,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32342703,Remote Management of Pacemaker Patients With Biennial In-Clinic Evaluation: Continuous Home Monitoring in the Japanese At-Home Study: A Randomized Clinical Trial.,"BACKGROUND


Current expert consensus recommends remote monitoring for cardiac implantable electronic devices, with at least annual in-office follow-up. We studied safety and resource consumption of exclusive remote follow-up (RFU) in pacemaker patients for 2 years.
METHODS


In Japan, consecutive pacemaker patients committed to remote monitoring were randomized to either RFU or conventional in-office follow-up (conventional follow-up) at twice yearly intervals. RFU patients were only seen if indicated by remote monitoring. All returned to hospital after 2 years. The primary end point was a composite of death, stroke, or cardiovascular events requiring surgery, and the primary hypothesis was noninferiority with 5% margin.
RESULTS


Of 1274 randomized patients (50.4% female, age 77±10 years), 558 (RFU) and 550 (Conventional follow-up) patients reached either the primary end point or 24 months follow-up. The primary end point occurred in 10.9% and 11.8%, respectively ( P =0.0012 for noninferiority). The median (interquartile range) number of in-office follow-ups was 0.50 (0.50-0.63) in RFU and 2.01 (1.93-2.05) in conventional follow-up per patient-year ( P <0.001). Insurance claims for follow-ups and directly related diagnostic procedures were 18 800 Yen (16 500-20 700 Yen) in RFU and 21 400 Yen (16 700-25 900 Yen) in conventional follow-up ( P <0.001). Only 1.4% of remote follow-ups triggered an unscheduled in-office follow-up, and only 1.5% of scheduled in-office follow-ups were considered actionable.
CONCLUSIONS


Replacing periodic in-office follow-ups with remote follow-ups for 2 years in pacemaker patients committed to remote monitoring does not increase the occurrence of major cardiovascular events and reduces resource consumption. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT01523704.",2020,"Only 1.4% of remote follow-ups triggered an unscheduled in-office follow-up, and only 1.5% of scheduled in-office follow-ups were considered actionable.  ","['In Japan, consecutive pacemaker patients committed to RM', '1274 randomized patients (50.4% female, age 77±10 years), 558 (RFU) and 550 (CFU) patients reached either the primary endpoint or 24 months follow-up', 'Pacemaker Patients with Biennial In-clinic Evaluation', 'pacemaker patients for two years']","['exclusive remote follow-up (RFU', 'RFU']","['composite of death, stroke, or cardiovascular events requiring surgery, and the primary hypothesis was non-inferiority with 5% margin', 'median (IQR) number of in-office follow-ups']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",1274.0,0.189135,"Only 1.4% of remote follow-ups triggered an unscheduled in-office follow-up, and only 1.5% of scheduled in-office follow-ups were considered actionable.  ","[{'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiology, Fujita Health University School of Medicine, Aichi (E.W.).'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Cardiovascular Surgery, Shizuoka City Shizuoka Hospital (F.Y.).'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Goto', 'Affiliation': 'Department of Cardiology, Nagoya City University Hospital (T.G.), Aichi, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Asai', 'Affiliation': 'Department of Cardiology, Ichinomiya Municipal Hospital (T. Asai), Aichi, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiology, Handa City Hospital (T. Yamamoto), Aichi, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Hirooka', 'Affiliation': 'Department of Cardiology, National Hospital Organization Osaka National Hospital (K.H.), Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Cardiology, Kyorin University Hospital (T.S.), Tokyo, Japan.'}, {'ForeName': 'Atsunobu', 'Initials': 'A', 'LastName': 'Kasai', 'Affiliation': 'Department of Cardiology, Japanese Red Cross Ise Hospital, Mie (A.K.).'}, {'ForeName': 'Marehiko', 'Initials': 'M', 'LastName': 'Ueda', 'Affiliation': 'Department of Cardiology, Chiba University Hospital (M.U.), Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamakawa', 'Affiliation': 'Department of Cardiology, Teikyo University Hospital (T. Yamakawa), Tokyo, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Ueda', 'Affiliation': 'Department of Cardiology, Osaka Police Hospital, Japan (Y.U.).'}, {'ForeName': 'Katsuhito', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiology, Kochi Health Sciences Center, Japan (K.Y.).'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Cardiology, JA Toride Medical Ctr, Ibaraki, Japan (T.T.).'}, {'ForeName': 'Yoshinao', 'Initials': 'Y', 'LastName': 'Sugai', 'Affiliation': 'Department of Cardiology, Hiraka General Hospital, Akita, Japan (Y.S.).'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiology, Kasukabe Chuo General Hospital, Saitama, Japan (K.T.).'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Hiramatsu', 'Affiliation': 'Department of Cardiology, Fukuyama Cardiovascular Hospital, Hiroshima, Japan (S.H.).'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Arakawa', 'Affiliation': 'Department of Cardiology, Daido Hospital, Aichi, Japan (T. Arakawa).'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schrader', 'Affiliation': 'Biotronik, Berlin, Germany (J.S.).'}, {'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Varma', 'Affiliation': 'Cleveland Clinic, Heart & Vascular Institute, OH (N.V.).'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan (K.A.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.007734']
1,32343000,Randomised clinical trial: faecal microbiota transplantation versus autologous placebo administered via colonoscopy in irritable bowel syndrome.,"BACKGROUND


Irritable bowel syndrome (IBS) has been associated with microbial dysbiosis.
AIM


To investigate the efficacy of faecal microbiota transplantation (FMT) in the treatment of IBS.
METHODS


Forty-nine IBS patients were randomised to receive autologous or allogenic FMT via colonoscopy. The primary endpoint was a sustained, minimum of 50-point, reduction in the IBS Symptom Severity Score. The secondary outcomes were levels of anxiety and depression, changes in quality of life, gut microbiota and faecal water content as assessed with validated questionnaires, intestinal microbiota composition and stool dry weight.
RESULTS


The primary endpoint was not achieved in either group. However, there was a transient reduction in the mean IBS Symptom Severity Score in the FMT group at 12 weeks after treatment as compared to baseline (P = 0.01). The groups did not differ in the number of patients achieving clinical response at 12 weeks. In the FMT-treated patients, microbial composition had changed to resemble that of the donor and the stool water content decreased significantly compared to baseline. The depression score decreased in patients with a reduction in IBS symptoms after FMT, but not in those placebo-treated patients who experienced a reduction in IBS symptoms.
CONCLUSIONS


FMT provided only a transient relief of symptoms, although it induced a sustained alteration in the microbiota of IBS patients. Therefore, FMT delivered by a single infusion via colonoscopy cannot be recommended as a treatment for IBS in clinical practice. ClinicalTrials.Org, Trial registration number: NCT03561519.",2020,"The depression score decreased in patients with a reduction in IBS symptoms after FMT, but not in those placebo-treated patients who experienced a reduction in IBS symptoms.
","['irritable bowel syndrome', 'Forty-nine', 'IBS patients', 'Irritable bowel syndrome (IBS']","['FMT', 'faecal microbiota transplantation versus autologous placebo', 'faecal microbiota transplantation (FMT', 'autologous or allogenic FMT via colonoscopy']","['sustained, minimum of 50-point, reduction in the IBS Symptom Severity Score', 'microbial composition', 'number of patients achieving clinical response', 'IBS symptoms', 'stool water content', 'levels of anxiety and depression, changes in quality of life, gut microbiota and faecal water content as assessed with validated questionnaires, intestinal microbiota composition and stool dry weight', 'depression score', 'mean IBS Symptom Severity Score']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",49.0,0.164282,"The depression score decreased in patients with a reduction in IBS symptoms after FMT, but not in those placebo-treated patients who experienced a reduction in IBS symptoms.
","[{'ForeName': 'Perttu', 'Initials': 'P', 'LastName': 'Lahtinen', 'Affiliation': 'Department of Gastroenterology, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Jalanka', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hartikainen', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Mattila', 'Affiliation': 'Department of Infectious Diseases, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Hillilä', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Punkkinen', 'Affiliation': 'Department of Gastroenterology, Porvoo Hospital, Porvoo, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Koskenpato', 'Affiliation': 'Department of Gastroenterology, Aava Medical Centre, Helsinki, Finland.'}, {'ForeName': 'Veli-Jukka', 'Initials': 'VJ', 'LastName': 'Anttila', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Tillonen', 'Affiliation': 'Department of Gastroenterology, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Reetta', 'Initials': 'R', 'LastName': 'Satokari', 'Affiliation': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Perttu', 'Initials': 'P', 'LastName': 'Arkkila', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15740']
2,32343001,Randomised clinical trial: the effectiveness of Gaviscon Advance vs non-alginate antacid in suppression of acid pocket and post-prandial reflux in obese individuals after late-night supper.,"BACKGROUND


Late-night supper increases the risk of postprandial reflux from the acid pocket especially in obesity. An alginate-based, raft-forming medication may be useful for obese patients with GERD.
AIMS


To compare the efficacy of Gaviscon Advance (Reckitt Benckiser, UK) and a non-alginate antacid in post-supper suppression of the acid pocket and post-prandial reflux among obese participants.
METHODS


Participants underwent 48 h wireless and probe-based pH-metry recording of the acid pocket and lower oesophagus, respectively, and were randomised to single post-supper (10 pm) dose of either Gaviscon Advance or a non-alginate antacid on the second night. Primary outcomes were suppression of median pH of acid pocket and lower oesophagus, measured every 10-minutes post-supper for 1 h. Secondary outcomes were suppression of % time pH < 4 at lower oesophagus and improvement in frequency and visual analogue score (VAS) of regurgitation.
RESULTS


Of the 81 screened participants, 55 were excluded and 26 (mean age 33.5 years, males 77.8% and BMI 32.8 kg/m 2  ) were randomised to Gaviscon Advance (n = 13) or antacid (n = 13). Median pH of the acid pocket but not the lower oesophagus was suppressed with Gaviscon Advance vs antacid (all P < 0.04) Gaviscon Advance but not antacid significantly reduced in % time pH < 4, symptom frequency and VAS on day 2 vs day 1 (all P < 0.05).
CONCLUSIONS


Among obese individuals, Gaviscon Advance was superior to a non-alginate antacid in post-supper suppression of the acid pocket. (Clinical trial registration unique identifier: NCT03516188).",2020,"Among obese individuals, Gaviscon Advance is was superior to a non-alginate antacid in post-supper suppression of the acid pocket.","['Participants underwent 48\xa0h wireless and probe-based pH-metry recording of the acid pocket and lower oesophagus, respectively', 'Of the 81 screened participants, 55 were excluded and 26 (mean age 33.5\xa0years, males 77.8% and BMI 32.8\xa0kg/m 2  ', 'obese individuals after late-night supper', 'obese participants', 'obese patients with GERD']","['Gaviscon Advance (Reckitt Benckiser, UK) and a non-alginate antacid', 'antacid', 'Gaviscon Advance', 'Gaviscon Advance vs antacid', 'Gaviscon Advance vs non-alginate antacid', 'Gaviscon Advance or a non-alginate antacid']","['suppression of % time pH', 'Median pH of the acid pocket', 'symptom frequency and VAS', 'frequency and visual analogue score (VAS) of regurgitation', 'suppression of median pH of acid pocket and lower oesophagus']","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}]","[{'cui': 'C0061146', 'cui_str': 'Gaviscon'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0003138', 'cui_str': 'Antacid'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0436350', 'cui_str': 'Symptom frequency'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}]",81.0,0.0540182,"Among obese individuals, Gaviscon Advance is was superior to a non-alginate antacid in post-supper suppression of the acid pocket.","[{'ForeName': 'Mohd Adli', 'Initials': 'MA', 'LastName': 'Deraman', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}, {'ForeName': 'Muhammad Ilham', 'Initials': 'MI', 'LastName': 'Abdul Hafidz', 'Affiliation': 'Faculty of Medicine, Universiti Teknologi MARA, Sungai Buloh, Malaysia.'}, {'ForeName': 'Rona Marie', 'Initials': 'RM', 'LastName': 'Lawenko', 'Affiliation': 'De La Salle Health Sciences Institute, Dasmarinas, Philippines.'}, {'ForeName': 'Zheng Feei', 'Initials': 'ZF', 'LastName': 'Ma', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}, {'ForeName': 'Mung Seong', 'Initials': 'MS', 'LastName': 'Wong', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}, {'ForeName': 'Cathal', 'Initials': 'C', 'LastName': 'Coyle', 'Affiliation': 'Reckitt Benckiser, Slough, UK.'}, {'ForeName': 'Yeong Yeh', 'Initials': 'YY', 'LastName': 'Lee', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15746']
3,32343246,An Electronic Medication Module to Improve Health Literacy in Patients With Type 2 Diabetes Mellitus: Pilot Randomized Controlled Trial.,"BACKGROUND


In primary care, patients play a crucial role in managing care processes and handling drug treatment. A decisive factor for success is their health literacy, and several interventions have been introduced to support patients in fulfilling their responsibility.
OBJECTIVE


The aim of this study is to assess the influence of such an intervention (ie, a medication module) within a patient-led electronic health record on patients' health literacy.
METHODS


We conducted a randomized controlled study among community-dwelling patients with type 2 diabetes mellitus. Patients were recruited from primary care practices. After randomization, patients either had access to an internet-based medication module allowing them to store their medication information, look up drug information, and print a medication schedule (intervention group), or they received an information brochure on the importance of medication schedules (control group). After 4-8 weeks, all patients were invited to attend a structured medication review (ie, follow-up visit). Data were collected via questionnaires before the start of the intervention and during the follow-up visit. The main outcome measure was the mean difference in health literacy between baseline and follow-up assessments of patients in the control and intervention groups.
RESULTS


Of 116 recruited patients, 107 (92.2%) completed the follow-up assessment and were eligible for intention-to-treat analyses. Only 73 patients, of which 29 were in the intervention group, followed the study protocol and were eligible for per-protocol analysis. No differences in overall health literacy were observed in either the intention-to-treat or in the per-protocol cohorts. Reasons for a null effect might be that the cohort was not particularly enriched with participants with low health literacy, thus precluding measurable improvement (ie, ceiling effect). Moreover, the success of implementation was considered poor because both the correct application of the study procedure (ie, randomization according to the protocol and dropout of 29 patients) and the actual interaction with the medication module was modest (ie, dropout of 9 patients).
CONCLUSIONS


The conduct of this randomized controlled study was challenging, leaving it open whether inadequate implementation, too short of a duration, or insufficient efficacy of the intervention, as such, contributed to the null effect of this study. This clearly outlines the value of piloting complex interventions and the accompanying process evaluations.",2020,No differences in overall health literacy were observed in either the intention-to-treat or in the per-protocol cohorts.,"['Patients were recruited from primary care practices', 'Of 116 recruited patients, 107 (92.2%) completed the follow-up assessment and were eligible for intention-to-treat analyses', 'community-dwelling patients with type 2 diabetes mellitus', 'Patients', ""patients' health literacy"", 'With Type 2 Diabetes Mellitus']",[],"['overall health literacy', 'mean difference in health literacy', 'Health Literacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",116.0,0.112451,No differences in overall health literacy were observed in either the intention-to-treat or in the per-protocol cohorts.,"[{'ForeName': 'Hanna Marita', 'Initials': 'HM', 'LastName': 'Seidling', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Mahler', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Strauß', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Weis', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Stützle', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Krisam', 'Affiliation': 'Institute of Medical Biometry and Informatics, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'See Acknowledgments, .'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Szecsenyi', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Walter Emil', 'Initials': 'WE', 'LastName': 'Haefeli', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany.'}]",JMIR formative research,['10.2196/13746']
4,32343308,"Dexmedetomidine with sufentanil in intravenous patient-controlled analgesia for relief from postoperative pain, inflammation and delirium after esophageal cancer surgery.","BACKGROUND AND AIMS


Postoperative pain can cause serious adverse reactions that severely affect postoperative outcome. The present study evaluated the effect of dexmedetomidine (DEX) added to sufentanil in intravenous patient-controlled analgesia (PCA) on the relief of pain and inflammatory responses during postoperative recovery of patients undergoing a combined thoracoscopic-laparoscopic esophagectomy (TLE).
METHODS


Sixty patients undergoing TLE were randomly allocated to receive 1 μg/ml of sufentanil alone (Group S) or 1 μg/ml of sufentanil plus 2.5 μg/ml of DEX (Group D) for postoperative intravenous (IV) PCA. Postoperative pain relief, cumulative PCA requirements, inflammatory marker levels, delirium and recovery were assessed.
RESULTS


A joint DEX and sufentanil regimen significantly reduced the area under the curve of numerical rating scores for pain at rest (NRSR) and coughing (NRSC) at 1-48 h postoperatively (P = 0.000) that were associated with lower PCA-delivered cumulative sufentanil consumption and less PCA frequency until 48 h postoperatively (P < 0.05 and P < 0.0001, respectively). The simultaneous administration of DEX and sufentanil significantly reduced plasma IL-6 and TNF-α concentrations and increased IL-10 level (P < 0.0001, P = 0.0003 and P = 0.0345, respectively), accompanied by better postoperative delirium categories and health statuses of patients (P = 0.024 and P < 0.05, respectively). There was no hypotension, bradycardia, respiratory depression or oversedation in Group D.
CONCLUSION


Patients receiving DEX in addition to IV PCA sufentanil for TLE exhibited better postoperative analgesia, fewer inflammatory responses and lower postoperative delirium categories and better health statuses.",2020,"Patients receiving DEX in addition to IV PCA sufentanil for TLE exhibited better postoperative analgesia, fewer inflammatory responses, and lower postoperative delirium categories and better health statuses.","['patients undergoing a', 'after Esophageal Cancer Surgery', 'Sixty patients undergoing TLE']","['Dexmedetomidine with Sufentanil', 'postoperative intravenous (IV) PCA', 'sufentanil alone (Group S) or 1 μg/ml of sufentanil plus 2.5 μg', 'DEX', 'dexmedetomidine (DEX', 'sufentanil', 'DEX and sufentanil', 'combined thoracoscopic-laparoscopic esophagectomy (TLE', 'IV PCA sufentanil', 'intravenous patient-controlled analgesia (PCA']","['cumulative sufentanil consumption and less PCA frequency', 'Postoperative Pain, Inflammation, and Delirium', 'postoperative delirium categories and health statuses', 'hypotension, bradycardia, respiratory depression, or oversedation', 'area under the curve of numerical rating scores for pain at rest (NRSR) and coughing (NRSC', 'Postoperative pain relief, cumulative PCA requirements, inflammatory marker levels, delirium, and recovery', 'postoperative analgesia, fewer inflammatory responses, and lower postoperative delirium categories and better health statuses', 'plasma IL-6 and TNF-α concentrations and increased IL-10 level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0542127', 'cui_str': 'Oversedation'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",60.0,0.453352,"Patients receiving DEX in addition to IV PCA sufentanil for TLE exhibited better postoperative analgesia, fewer inflammatory responses, and lower postoperative delirium categories and better health statuses.","[{'ForeName': 'Chaoliang', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Yida', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, China.'}, {'ForeName': 'Zhetao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Zeyuan', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Department of Pharmacy, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Qingtian', 'Initials': 'Q', 'LastName': 'Geng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Jiawu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Chai', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}]",Bioscience reports,['10.1042/BSR20193410']
5,32339359,A Pilot Randomized Controlled Trial of the PTSD Coach App Following Motor Vehicle Crash-related Injury.,"OBJECTIVE


Posttraumatic stress disorder (PTSD) symptoms (PTSS) are common after minor injuries and can impair recovery. We sought to understand whether an evidence-based mobile phone application with self-help tools (PTSD Coach) could be useful to improve recovery after acute trauma among injured emergency department (ED) patients. This pilot study examined the feasibility, acceptability, and potential benefit of using PTSD Coach among acutely injured motor vehicle crash (MVC) patients.
METHODS


From September 2017 to September 2018, we recruited adult patients within 24 hours post-MVC from the EDs of two Level I trauma centers in the United States. We randomly assigned 64 injured adults to either the PTSD Coach (n = 33) or treatment as usual (TAU; n = 31) condition. We assessed PTSS and associated symptoms at 1 month (83% retained) and 3 months (73% retained) postenrollment.
RESULTS


Enrollment was feasible (74% of eligible subjects participated) but usability and engagement were low (67% used PTSD Coach at least once, primarily in week 1); 76% of those who used it rated the app as moderately to extremely helpful. No differences emerged between groups in PTSS outcomes. Exploratory analyses among black subjects (n = 21) indicated that those in the PTSD Coach condition (vs. TAU) reported marginally lower PTSS (95% CI = -0.30 to 37.77) and higher PTSS coping self-efficacy (95% CI = -58.20 to -3.61) at 3 months.
CONCLUSIONS


We demonstrated feasibility to recruit acutely injured ED patients into an app-based intervention study, yet mixed evidence emerged for the usability and benefit of PTSD Coach. Most patients used the app once and rated it favorably in regard to satisfaction with and helpfulness, but longitudinal engagement was low. This latter finding may explain the lack of overall effects on PTSS. Additional research is warranted regarding whether targeting more symptomatic patients and the addition of engagement and support features can improve efficacy.",2020,No differences emerged between groups in PTSS outcomes.,"['64 injured adults to either the', 'acute trauma among injured emergency department (ED) patients', 'acutely injured motor-vehicle crash (MVC) patients', 'From September 2017-September 2018', 'adult patients within 24 hours post-MVC from the EDs of two Level 1 trauma centers in the United States', 'Black subjects (n = 21']","['evidence-based mobile phone application with self-help tools (PTSD Coach', 'PTSD Coach']","['PTSS coping self-efficacy', 'PTSD symptoms (PTSS) and associated symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175845', 'cui_str': 'Motor vehicle'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}]",64.0,0.242411,No differences emerged between groups in PTSS outcomes.,"[{'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Pacella-LaBarbara', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Suffoletto', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Kuhn', 'Affiliation': 'the, Dissemination and Training Division, National Center for PTSD, Palo Alto, CA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Germain', 'Affiliation': 'and the, Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Stephany', 'Initials': 'S', 'LastName': 'Jaramillo', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Repine', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Clifton W', 'Initials': 'CW', 'LastName': 'Callaway', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14000']
6,32339447,"hhIL-7-hyFc, A Long-Acting IL-7, Increased Absolute Lymphocyte Count in Healthy Subjects.","A low lymphocyte count puts immune-compromised patients at risk of mortality. hIL-7-hyFc is a homodimeric interleukin-7 (IL-7), a potent T-cell amplifier, fused to the hybridizing IgD/IgG4 immunoglobulin domain. We performed a randomized, double-blind, placebo-controlled, dose-escalation, phase I study to assess the pharmacokinetic, pharmacodynamic, safety, tolerability, and immunogenicity profiles of hIL-7-hyFc administered s.c. and i.m. to healthy volunteers. Thirty subjects randomly received hIL-7-hyFc or its matching placebo in an 8:2 ratio at 20, 60 μg/kg s.c., or 60 μg/kg i.m. The hIL-7-hyFc was slowly absorbed and its terminal half-life was 63.26 hours after i.m. administration. The hIL-7-hyFc increased absolute lymphocyte count, mostly in T-cells, which peaked 3 weeks after administration and then lasted for several additional weeks. The hIL-7-hyFc was well-tolerated after a single s.c. and i.m. administration. Injection site reaction was the most common treatment-emergent adverse event, which resolved spontaneously without treatment. The hIL-7-hyFc can be developed into a beneficial treatment option for patients with compromised T-cell immunity. This trial was registered at www.clinicaltrials.gov as #NCT02860715.",2020,"hIL-7-hyFc increased absolute lymphocyte count, mostly in T-cells, which peaked 3 weeks after administration and then lasted for several additional weeks.","['healthy volunteers', 'Thirty subjects randomly received', 'healthy subjects', 'patients with compromised T-cell immunity']","['hIL-7-hyFc or its matching placebo', 'hIL-7-hyFc administered subcutaneously (SC) and intramuscularly (IM', 'placebo']","['pharmacokinetic, pharmacodynamic, safety, tolerability and immunogenicity profiles', 'hIL-7-hyFc', 'absolute lymphocyte count']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}]",30.0,0.207898,"hIL-7-hyFc increased absolute lymphocyte count, mostly in T-cells, which peaked 3 weeks after administration and then lasted for several additional weeks.","[{'ForeName': 'Sang Won', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'NeoImmuneTech, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'MinKyu', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Genexine, Inc., Seongnam-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Eui-Cheol', 'Initials': 'EC', 'LastName': 'Shin', 'Affiliation': 'Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Su-Hyung', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'So Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Biomedical Science and Engineering Interdisciplinary Program, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Yeon-Kyung', 'Initials': 'YK', 'LastName': 'Oh', 'Affiliation': 'Genexine, Inc., Seongnam-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Byung Ha', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'NeoImmuneTech, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Se Hwan', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': 'NeoImmuneTech, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Young Chul', 'Initials': 'YC', 'LastName': 'Sung', 'Affiliation': 'Genexine, Inc., Seongnam-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}]",Clinical and translational science,['10.1111/cts.12800']
7,32339499,"Effects of exogenous ghrelin administration and ghrelin receptor blockade, in combination with alcohol, on peripheral inflammatory markers in heavy-drinking individuals: Results from two human laboratory studies.","The ghrelin system has been garnering interest for its role in different neuropsychiatric disorders, including alcohol use disorder (AUD). Accordingly, targeting the ghrelin system is under investigation as a potential novel therapeutic approach. While alcohol provokes the immune system and inflammatory responses, ghrelin has potent immunomodulatory and anti-inflammatory properties. The present study aimed to shed light on the ""crosstalk"" between ghrelin and inflammation by examining the effects of exogenous ghrelin administration and ghrelin receptor blockade on peripheral inflammatory markers in the context of two human laboratory studies with alcohol administration. Non-treatment-seeking, heavy-drinking individuals with alcohol dependence, the majority of whom were African American males, were enrolled. In the first randomized, crossover, double-blind, placebo-controlled human laboratory study, participants underwent two experimental paradigms - an intravenous alcohol self-administration (IV-ASA) and an intravenous alcohol clamp (IV-AC) - each consisting of two counterbalanced sessions (ghrelin, placebo). A loading dose of intravenous ghrelin (3 mcg/kg) or placebo, followed by a continuous ghrelin (16.9 ng/kg/min) or placebo infusion was administered. In the second dose-escalating, single-blind, placebo-controlled human laboratory phase 1b study, participants were dosed with an oral ghrelin receptor blocker (PF-5190457) and underwent an oral alcohol challenge. Repeated blood samples were collected, and plasma concentrations of the following inflammatory markers were measured: C-reactive protein (CRP), interleukin (IL)-6, IL-10, IL-18, and tumor necrosis factor alpha (TNF-α). During the IV-ASA experiment, significant drug × time interaction effects were observed for IL-6 (F 3,36  = 3.345, p = 0.030) and IL-10 (F 3,53.2  = 4.638, p = 0.006), indicating that ghrelin, compared to placebo, significantly reduced blood concentrations of the proinflammatory cytokine IL-6, while increasing blood concentrations of the anti-inflammatory cytokine IL-10. No significant drug × time interaction effects were observed during the IV-AC experiment, possibly because of its much shorter duration and/or smaller sample. Treatment with PF-5190457, compared to placebo, had no significant effect on the inflammatory markers investigated. In conclusion, a supraphysiologic pharmacological challenge with exogenous ghrelin in heavy-drinking individuals produced anti-inflammatory effects in the context of intravenous alcohol administration. On the contrary, ghrelin receptor blockade did not lead to any change in the inflammatory markers included in this study. Mechanistic studies are required to better understand the interaction between ghrelin, alcohol, and inflammatory processes.",2020,"(F 3,36  = 3.345, p = 0.030) and IL-10 (F 3,53.2  = 4.638, p = 0.006), indicating that ghrelin, compared to placebo, significantly reduced blood concentrations of the proinflammatory cytokine IL-6, while increasing blood concentrations of the anti-inflammatory cytokine IL-10.","['heavy-drinking individuals', 'two human laboratory studies with alcohol administration. Non-treatment-seeking, heavy-drinking individuals with alcohol dependence, the majority of whom were African American males']","['PF-5190457', 'oral ghrelin receptor blocker (PF-5190457) and underwent an oral alcohol challenge', 'intravenous alcohol self-administration (IV-ASA) and an intravenous alcohol clamp (IV-AC) - each consisting of two counterbalanced sessions (ghrelin, placebo', 'placebo', 'exogenous ghrelin administration and ghrelin receptor blockade', 'intravenous ghrelin']","['blood concentrations of the anti-inflammatory cytokine IL-10', 'IL-6', 'C-reactive protein (CRP), interleukin (IL)-6, IL-10, IL-18, and tumor necrosis factor alpha (TNF-α', 'time interaction effects', 'IL-10', 'blood concentrations of the proinflammatory cytokine IL-6']","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4279098', 'cui_str': 'PF-5190457'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0391690', 'cui_str': 'Growth Hormone Secretagogue Receptor'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.168388,"(F 3,36  = 3.345, p = 0.030) and IL-10 (F 3,53.2  = 4.638, p = 0.006), indicating that ghrelin, compared to placebo, significantly reduced blood concentrations of the proinflammatory cytokine IL-6, while increasing blood concentrations of the anti-inflammatory cytokine IL-10.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States; Center on Compulsive Behaviors, National Institutes of Health, Bethesda, MD, United States; Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Portelli', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Gray R', 'Initials': 'GR', 'LastName': 'McDiarmid', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Munjal', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Abshire', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Jillian T', 'Initials': 'JT', 'LastName': 'Battista', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Brittney D', 'Initials': 'BD', 'LastName': 'Browning', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Deschaine', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Akhlaghi', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, United States.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, United States; Center on Compulsive Behaviors, National Institutes of Health, Bethesda, MD, United States; Medication Development Program, National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Baltimore, MD, United States; Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University, Providence, RI, United States. Electronic address: lorenzo.leggio@nih.gov.'}]",Brain research,['10.1016/j.brainres.2020.146851']
8,32339648,Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma.,"BACKGROUND


The phase 3 JAVELIN Renal 101 trial (NCT02684006) demonstrated significantly improved progression-free survival (PFS) with first-line avelumab plus axitinib vs sunitinib in advanced renal cell carcinoma (aRCC). We report updated efficacy data from the second interim analysis.
PATIENTS AND METHODS


Treatment-naïve patients with aRCC were randomized (1:1) to receive avelumab (10 mg/kg) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary endpoints were PFS and overall survival (OS) among patients with PD-L1+ tumors. Key secondary endpoints were OS and PFS in the overall population.
RESULTS


Of 886 patients, 442 were randomized to the avelumab plus axitinib arm and 444 to the sunitinib arm; 270 and 290 had PD-L1+ tumors, respectively. After a minimum follow-up of 13 months (data cutoff Jan 28, 2019), PFS was significantly longer in the avelumab plus axitinib arm than in the sunitinib arm (PD-L1+ population: hazard ratio [HR] 0.62 [95% CI, 0.490-0.777]; 1-sided P < 0.0001; median 13.8 [95% CI, 10.1-20.7] vs 7.0 months [95% CI, 5.7-9.6]; overall population: HR 0.69 [95% CI, 0.574-0.825]; 1-sided P < 0.0001; median 13.3 [95% CI, 11.1-15.3] vs 8.0 months [95% CI, 6.7-9.8]). OS data were immature (PD-L1+ population: HR 0.828 [95% CI, 0.596-1.151]; 1-sided P = 0.1301; overall population: HR 0.796 [95% CI, 0.616-1.027]; 1-sided P = 0.0392).
CONCLUSION


Among patients with previously untreated aRCC, treatment with avelumab plus axitinib continued to result in a statistically significant improvement in PFS vs sunitinib; OS data were still immature.",2020,OS data were immature (PD-L1+ population: HR 0.828,"['886 patients', 'advanced renal cell carcinoma (aRCC', 'patients with advanced renal cell carcinoma', 'Treatment-naïve patients with aRCC']","['axitinib (5 mg) orally twice daily or sunitinib', 'avelumab plus axitinib versus sunitinib', 'avelumab', 'avelumab plus axitinib']","['progression-free survival (PFS', 'PFS', 'OS and PFS in the overall population', 'PFS and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",,0.268726,OS data were immature (PD-L1+ population: HR 0.828,"[{'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, 450 Brookline Ave, Boston, MA 02215, USA;. Electronic address: toni_choueiri@dcfi.harvard.edu.""}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY 10065, USA.'}, {'ForeName': 'B I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Haanen', 'Affiliation': 'Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam, 1066 CX, The Netherlands.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Campbell', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Venugopal', 'Affiliation': 'University of Glasgow, Beatson West of Scotland Cancer Centre, 1053, Great Western Rd, Glasgow, G12 0YN, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kollmannsberger', 'Affiliation': 'British Columbia Cancer Agency, Vancouver Centre, 600 West 10th Avenue, Vancouver, BC, V5Z 4E6, Canada.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gravis-Mescam', 'Affiliation': 'Institut Paoli-Calmettes, Department of Medical Oncology, Aix-Marseille Université, Inserm, CNRS, CRCM, Marseille, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Uemura', 'Affiliation': 'Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'M-O', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Jena University Hospital, Department of Urology, Am Klinikum 1, 07747 Jena, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Macquarie University, F10A Building, 2 Technology Place, Suite 407, Level 4, Sydney, NSW, 2109, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schmidinger', 'Affiliation': 'Medical University of Vienna; Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Waehringer Guertel 18-20, A-1090 Vienna, Austria.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden NHS Foundation Trust, Fulham Rd, London SW3 6JJ, UK.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown University Medical Center, 3800 Reservoir Rd NW, Washington, DC 20057, USA.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'City of Hope National Medical Center, 1500 E Duarte Rd, Duarte, CA 91010, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Pfizer, 300 Technology Square, Cambridge, MA 02138, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mariani', 'Affiliation': 'Pfizer Italia SRL, Via Anna Maria Mozzoni, 12, 20152 Milano, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Krishnaswami', 'Affiliation': 'Pfizer, 445 Eastern Point Rd, Groton, CT 06340, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cislo', 'Affiliation': 'Pfizer, 235 E 42nd St, New York, NY 10017, USA.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Chudnovsky', 'Affiliation': 'Pfizer, 300 Technology Square, Cambridge, MA 02138, USA.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Fowst', 'Affiliation': 'Pfizer Italia SRL, Via Anna Maria Mozzoni, 12, 20152 Milano, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'Pfizer, 445 Eastern Point Rd, Groton, CT 06340, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'di Pietro', 'Affiliation': 'Pfizer Italia SRL, Via Anna Maria Mozzoni, 12, 20152 Milano, Lombardia, Italy.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Institut Gustave Roussy, 114 rue Edouard Vaillant, Villejuif 94805, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.010']
9,32339664,"Effect of prefrontal tDCS on resting brain fMRI graph measures in Alcohol Use Disorders: A randomized, double-blind, sham-controlled study.","OBJECTIVES


Transcranial Direct Current Stimulation (tDCS) is a promising new adjuvant approach in the treatment of Alcohol Use Disorders (AUDs) that has the potential to ameliorate the aberrations secondary to chronic alcohol use. In this study, using a randomized, double-blind, sham-controlled, parallel-arm design, we examined the effects of prefrontal tDCS on resting-state functional magnetic resonance imaging (rsfMRI) and its correlates with impulsivity and time to first lapse in subjects with AUDs.
METHODS


Patients with AUD as per DSM-5 criteria were randomly allocated to receive a five-day course of either verum-tDCS (n = 12) or sham-tDCS (n = 12). Of them, 21 patients (verum/sham = 11/10) participated in both baseline and post-intervention 10-min rsfMRI sessions. Outside the scanner, subjects also performed the Stop-Signal Task at two time-points (baseline and post-intervention), which provided a measure of changes in impulsivity following tDCS. After completion of the post-intervention scan, all subjects were discharged and were followed-up for 90 days post-discharge or until lapse to first alcohol use.
RESULTS


Graph theoretical analysis of rsfMRI data revealed that verum-tDCS (but not sham) resulted in a significant increase in the global efficiency of brain networks with a concurrent significant reduction in global clustering; network-based statistical analysis identified a significant increase in the functional connectivity of a specific sub-network involving prefrontal regions. Furthermore, increased global efficiency of brain networks following verum tDCS predicted a significantly reduced likelihood of relapse. In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity.
CONCLUSIONS


The present study adds further support to the increasing evidence base for the clinical utility of tDCS in AUDs. Importantly, we observed improvement in both whole-brain network efficiency as well as inter-regional connectivity within a specific local prefrontal sub-network that is relevant to the neurobiology of AUDs. Replication and extension of these promising leads from the present study can facilitate clinical translation of tDCS, given its advantages (i.e. safety, cost-effectiveness, administration ease with potential for remotely-supervised / home-based application) for treating patients with AUDs.",2020,"In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity.
","['subjects with AUDs', 'Patients with AUD as per DSM-5 criteria', 'Alcohol Use Disorders', '21 patients (verum/sham\u202f=\u202f11/10) participated in both baseline and post-intervention 10-min rsfMRI sessions']","['prefrontal tDCS', 'Transcranial Direct Current Stimulation (tDCS', 'verum-tDCS (n\u202f=\u202f12) or sham-tDCS']","['resting brain fMRI graph measures', 'likelihood of relapse', 'global efficiency of brain networks', 'functional connectivity of a specific sub-network involving prefrontal regions']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",,0.15234,"In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity.
","[{'ForeName': 'Bharath', 'Initials': 'B', 'LastName': 'Holla', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Jitendriya', 'Initials': 'J', 'LastName': 'Biswal', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Vinutha', 'Initials': 'V', 'LastName': 'Ramesh', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Venkataram', 'Initials': 'V', 'LastName': 'Shivakumar', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Rose Dawn', 'Initials': 'RD', 'LastName': 'Bharath', 'Affiliation': 'Neuroimaging and Interventional Radiology, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Benegal', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Venkatasubramanian', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India. Electronic address: gvs@nimhans.ac.in.'}, {'ForeName': 'Prabhat Kumar', 'Initials': 'PK', 'LastName': 'Chand', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Murthy', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.109950']
10,32339768,Risk reduction through family therapy (RRFT): Protocol of a randomized controlled efficacy trial of an integrative treatment for co-occurring substance use problems and posttraumatic stress disorder symptoms in adolescents who have experienced interpersonal violence and other traumatic events.,"Decades of research demonstrate that childhood exposure to traumatic events, particularly interpersonal violence experiences (IPV; sexual abuse, physical abuse, witnessing violence), increases risk for negative behavioral and emotional outcomes, including substance use problems (SUP) and posttraumatic stress disorder (PTSD). Despite this well-established link-including empirical support for shared etiological and functional connections between SUP and PTSD -the field has been void of a gold standard treatment for adolescent populations. To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events. The purpose of this paper is to provide a detailed description of the design and methods of this RCT designed to reduce SUP, PTSD symptoms, and related risk behaviors, with outcomes measured from pre-treatment through 18 months post-entry. Specifically, the recruitment and sampling procedures, assessment measures and methods, description of the intervention, and planned statistical approaches to evaluating the full range of outcomes are detailed. Clinical and research implications of this work are also discussed.",2020,"To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events.","['adolescents who have experienced IPV and other traumatic events', 'adolescents who have experienced interpersonal violence and other traumatic events']","['integrative treatment', 'Risk Reduction through Family Therapy (RRFT']","['SUP, PTSD symptoms, and related risk behaviors', 'negative behavioral and emotional outcomes, including substance use problems (SUP) and posttraumatic stress disorder (PTSD']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C4751223', 'cui_str': 'Traumatic event'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0015618', 'cui_str': 'Family therapy'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",,0.0401951,"To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events.","[{'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Adams', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McCart', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Ashli J', 'Initials': 'AJ', 'LastName': 'Sheidow', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'de Arellano', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Carla Kmett', 'Initials': 'CK', 'LastName': 'Danielson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: danielso@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106012']
11,32339943,Effect of increased relative stiffness of the lumbar spine on hamstring muscle stretching in individuals with a history of low back pain suspected to have a clinical lumbar instability: A randomized crossover design.,"BACKGROUND


Theoretically, lumbopelvic stabilization techniques during hamstring muscle stretching could increase lumbar stiffness relative to hamstring muscle in individuals with a history of low back pain and suspected clinical lumbar instability. However, evidence to support this theory is limited. This study aimed to 1) determine changes in lumbopelvic, lumbar, and hip motions, and hamstring muscle length after stretching exercises with lumbopelvic stiffening or relaxing techniques, and 2) compare those changes between techniques.
METHODS


This study used a randomized crossover design. Thirty-two participants with a history of low back pain and bilateral hamstring muscle tightness were recruited. The order of the first technique was randomly assigned. After a 2-day washout, participants were crossed over to the second technique. Motion data during active forward trunk bending and bilateral hamstring muscle length during passive knee extension were collected pre- and post-intervention.
FINDINGS


Significant increases (P < 0.05) were found in bilateral hamstring muscle length for both techniques. However, stiffening technique demonstrated a significant decrease in lumbar motion (P < 0.05) and increase in hip motion (P < 0.05), while relaxing technique demonstrated trends showing increases in lumbar and hip motions (P = 0.134 and 0.115, respectively). The findings showed significantly greater improvement (P < 0.05) in lumbar and hip motions with stiffening technique.
INTERPRETATION


The findings suggest increased relative stiffness of the lumbar spine during hamstring muscle stretching can specifically lengthen bilateral hamstring muscle and decrease excessive lumbar motion. This stiffening technique may prevent excessive movement of the lumbar spine, thereby reducing the risk of recurrent low back pain.",2020,"However, stiffening technique demonstrated a significant decrease in lumbar motion (P < 0.05) and increase in hip motion (P < 0.05), while relaxing technique demonstrated trends showing increases in lumbar and hip motions (P = 0.134 and 0.115, respectively).","['Thirty-two participants with a history of low back pain and bilateral hamstring muscle tightness were recruited', 'individuals with a history of low back pain suspected to have a clinical lumbar instability', 'individuals with a history of low back pain and suspected clinical lumbar instability']","['lumbar spine', 'hamstring muscle stretching']","['lumbar motion', 'excessive lumbar motion', 'hip motion', 'lumbopelvic, lumbar, and hip motions, and hamstring muscle length', 'bilateral hamstring muscle length', 'lumbar and hip motions']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}]","[{'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0407178', 'cui_str': 'Stretching of muscle'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}]",32.0,0.0268945,"However, stiffening technique demonstrated a significant decrease in lumbar motion (P < 0.05) and increase in hip motion (P < 0.05), while relaxing technique demonstrated trends showing increases in lumbar and hip motions (P = 0.134 and 0.115, respectively).","[{'ForeName': 'Peemongkon', 'Initials': 'P', 'LastName': 'Wattananon', 'Affiliation': 'Motor Control and Neural Plasticity Lab, Faculty of Physical Therapy, Mahidol University, 999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170, Thailand. Electronic address: peemongkon.wat@mahidol.ac.th.'}, {'ForeName': 'Wallika', 'Initials': 'W', 'LastName': 'Prasertkul', 'Affiliation': 'Physical Therapy Clinic, Faculty of Physical Therapy, Mahidol University, 999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170, Thailand.. Electronic address: wallika.pra@mahidol.ac.th.'}, {'ForeName': 'Prasert', 'Initials': 'P', 'LastName': 'Sakulsriprasert', 'Affiliation': 'Biomechanics and Sport Lab, Faculty of Physical Therapy, Mahidol University, 999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170, Thailand. Electronic address: prasert.sak@mahido.ac.th.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Laskin', 'Affiliation': 'School of Physical Therapy and Rehabilitation Science, University of Montana, 135 Skaggs Building, Missoula, MT 59812, USA. Electronic address: james.laskin@umontana.edu.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.104996']
12,32339953,Effects of cardiopulmonary resuscitation training for Mozambican nursing students in a low-resource setting: An intervention study.,"BACKGROUND


There is an increasing incidence of cardiovascular diseases in Africa. Nurses' ability to undertake cardiopulmonary resuscitation (CPR) can significantly impact the survival of patients who experience cardiac arrest.
OBJECTIVES


We aimed to identify the effects of CPR training among Registered Nurse-Bachelor of Science in Nursing (RN-BSN) students in Mozambique.
DESIGN


A one-group pretest-posttest repeated-measures quasi-experimental design.
SETTING


Auditorium of a general hospital and 2 Anne manikins, but no automatic external defibrillator.
PARTICIPANTS


Thirty-two RN-BSN students.
METHODS


Students' attitudes and self-efficacy on CPR were measured by self-reported questionnaires three times (before, immediately after, and 20 weeks post intervention). Data were analyzed by the paired t-test and repeated-measures analysis of variance.
RESULTS


Attitude and self-efficacy scores of students on CPR significantly increased immediately after CPR training, but decreased 20 weeks after the intervention (p < .001). Sociodemographic characteristics did not significantly differ throughout the measurements of attitude or self-efficacy.
CONCLUSIONS


CPR manikin training positively affected attitude and self-efficacy in CPR among RN-BSN nursing students immediately, but not at 20 weeks, after the training. There is a need for research to repeatedly quantify parameters in a controlled study at different intervals and develop an instructor-training course customized to Mozambique.",2020,"RESULTS


Attitude and self-efficacy scores of students on CPR significantly increased immediately after CPR training, but decreased 20 weeks after the intervention (p < .001).","['patients who experience cardiac arrest', 'Registered Nurse-Bachelor of Science in Nursing (RN-BSN) students in Mozambique', 'Africa', 'Students', 'Auditorium of a general hospital and 2 Anne manikins, but no automatic external defibrillator.\nPARTICIPANTS\n\n\nThirty-two RN-BSN students', 'Mozambican nursing students in a low-resource setting']","['CPR training', 'CPR manikin training', 'cardiopulmonary resuscitation (CPR', 'cardiopulmonary resuscitation training']","['attitude or self-efficacy', 'Attitude and self-efficacy scores', 'attitude and self-efficacy', 'attitudes and self-efficacy on CPR', 'Sociodemographic characteristics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]",,0.0139191,"RESULTS


Attitude and self-efficacy scores of students on CPR significantly increased immediately after CPR training, but decreased 20 weeks after the intervention (p < .001).","[{'ForeName': 'Jeonghui', 'Initials': 'J', 'LastName': 'Seol', 'Affiliation': 'Department of Nursing, Bucheon University, 56 Sosa-Ro, Bucheon City 14774, Gyeonggi Province, Republic of Korea.'}, {'ForeName': 'Ogcheol', 'Initials': 'O', 'LastName': 'Lee', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, 84 Heukseok-Ro, Dongjak-Gu 06974, Seoul, Republic of Korea. Electronic address: leeoc@cau.ac.kr.'}]",Nurse education today,['10.1016/j.nedt.2020.104433']
13,32339933,"""A multicentre prospective randomized controlled clinical trial comparing the effectiveness and cost of a static air mattress and alternating air pressure mattress to prevent pressure ulcers in nursing home residents"".",,2020,,['nursing home residents'],['static air mattress and alternating air pressure mattress'],[],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0001876', 'cui_str': 'Air pressure'}]",[],,0.0890545,,"[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Fagart', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France. Electronic address: willy.fagart@chu-nimes.fr.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'De La Bachelerie', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blot', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dupeyron', 'Affiliation': 'Département de Médecine Physique et de Réadaptation, CHU de Nîmes, 30029 Nîmes, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chevalier', 'Affiliation': 'Laboratoire De Biostatistique, Épidémiologie, Santé Publique, Informatique Médicale, CHU de Nîmes, 30029 Nîmes, France.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103547']
14,32340150,"Effect of a 12-Week Almond-Enriched Diet on Biomarkers of Cognitive Performance, Mood, and Cardiometabolic Health in Older Overweight Adults.","Long term nut consumption is associated with reduced risk of coronary heart disease and better cognitive function. This study examined supplementing habitual diets with almonds or carbohydrate-rich snack foods (providing 15% energy) on biomarkers of cardiovascular and metabolic health, mood and cognitive performance. Participants (overweight/obese, 50-80 years) were randomised to an almond-enriched diet (AED) or isocaloric nut-free diet (NFD) for 12 weeks. Body weight, blood lipids, glucose, insulin, blood pressure (BP), arterial stiffness, cell adhesions molecules, C reactive protein (CRP), mood, and cognitive performance (working memory primary outcome), dietary profiles and energy intake/expenditure were measured at baseline and Week 12 in 128 participants (n = 63 AED, n = 65 NFD). Compared with NFD, AED was associated with altered macro and micronutrient profiles, but no differences in energy intake or expenditure. The AED significantly reduced triglycerides and SBP but there were no other changes in cardiometabolic biomarkers, mood, or cognitive performance. The inclusion of almonds in the diet improves aspects of cardiometabolic health without affecting cognitive performance or mood in overweight/obese adults.",2020,"The AED significantly reduced triglycerides and SBP but there were no other changes in cardiometabolic biomarkers, mood, or cognitive performance.","['overweight/obese adults', 'Older Overweight Adults', 'Participants (overweight/obese, 50-80 years']","['supplementing habitual diets with almonds or carbohydrate-rich snack foods', '12-Week Almond-Enriched Diet', 'almond-enriched diet (AED) or isocaloric nut-free diet (NFD']","['triglycerides and SBP', 'Biomarkers of Cognitive Performance, Mood, and Cardiometabolic Health', 'biomarkers of cardiovascular and metabolic health, mood and cognitive performance', 'energy intake or expenditure', 'Body weight, blood lipids, glucose, insulin, blood pressure (BP), arterial stiffness, cell adhesions molecules, C reactive protein (CRP), mood, and cognitive performance (working memory primary outcome), dietary profiles and energy intake/expenditure', 'cardiometabolic biomarkers, mood, or cognitive performance', 'risk of coronary heart disease and better cognitive function']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0452382', 'cui_str': 'Nut-free diet'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",128.0,0.0768591,"The AED significantly reduced triglycerides and SBP but there were no other changes in cardiometabolic biomarkers, mood, or cognitive performance.","[{'ForeName': 'Alison Mary', 'Initials': 'AM', 'LastName': 'Coates', 'Affiliation': 'School of Health Sciences, University of South Australia, Adelaide 5001, SA, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Morgillo', 'Affiliation': 'School of Health Sciences, University of South Australia, Adelaide 5001, SA, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Yandell', 'Affiliation': 'School of Health Sciences, University of South Australia, Adelaide 5001, SA, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Scholey', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne 3122, VIC, Australia.'}, {'ForeName': 'Jonathan David', 'Initials': 'JD', 'LastName': 'Buckley', 'Affiliation': 'School of Health Sciences, University of South Australia, Adelaide 5001, SA, Australia.'}, {'ForeName': 'Kathryn Ann', 'Initials': 'KA', 'LastName': 'Dyer', 'Affiliation': 'School of Health Sciences, University of South Australia, Adelaide 5001, SA, Australia.'}, {'ForeName': 'Alison Marie', 'Initials': 'AM', 'LastName': 'Hill', 'Affiliation': 'Alliance for Research in Nutrition, Exercise and Activity (ARENA), University of South Australia, Adelaide 5001, SA, Australia.'}]",Nutrients,['10.3390/nu12041180']
15,32340155,Impact of an Individualized Cognitive Training Intervention in Preschoolers from Poor Homes.,"Over the last few decades, different interventions were shown to be effective in changing cognitive performance in preschoolers from poor homes undertaking tasks with executive demands. However, this evidence also showed that not all children included in the intervention groups equally increased their performance levels, which could be related to individual and contextual variability. The present study aimed to explore the impact of a computerized cognitive training intervention with lab-based tasks in preschoolers from Unsatisfied Basic Needs (UBN) homes under the consideration of their baseline performance. In the context of a randomized controlled trial design, different interventions were administered to children according to their baseline performance in a variety of cognitive tasks (i.e., executive attention, inhibitory control, working memory, and planning demands). The results showed different patterns of impact on performance depending on the experimental group, supporting the importance of considering individual and contextual differences in the design of interventions aimed at optimizing executive functions in poverty-impacted sample populations in early stages of development.",2020,"Over the last few decades, different interventions were shown to be effective in changing cognitive performance in preschoolers from poor homes undertaking tasks with executive demands.","['preschoolers from Unsatisfied Basic Needs (UBN) homes under the consideration of their baseline performance', 'Preschoolers from Poor Homes']","['computerized cognitive training intervention with lab-based tasks', 'Individualized Cognitive Training Intervention']",['performance levels'],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0586055,"Over the last few decades, different interventions were shown to be effective in changing cognitive performance in preschoolers from poor homes undertaking tasks with executive demands.","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Giovannetti', 'Affiliation': 'Unidad de Neurobiología Aplicada (UNA), CEMIC-CONICET, Buenos Aires C1431FWO, Argentina.'}, {'ForeName': 'Marcos Luis', 'Initials': 'ML', 'LastName': 'Pietto', 'Affiliation': 'Unidad de Neurobiología Aplicada (UNA), CEMIC-CONICET, Buenos Aires C1431FWO, Argentina.'}, {'ForeName': 'María Soledad', 'Initials': 'MS', 'LastName': 'Segretín', 'Affiliation': 'Unidad de Neurobiología Aplicada (UNA), CEMIC-CONICET, Buenos Aires C1431FWO, Argentina.'}, {'ForeName': 'Sebastián Javier', 'Initials': 'SJ', 'LastName': 'Lipina', 'Affiliation': 'Unidad de Neurobiología Aplicada (UNA), CEMIC-CONICET, Buenos Aires C1431FWO, Argentina.'}]",International journal of environmental research and public health,['10.3390/ijerph17082912']
16,32340219,The TTCYB Study Protocol: A Tailored Print Message Intervention to Improve Cardiovascular Patients' Lifestyles.,"This article describes the development of the ""Time to Change Your Behavior"" (TTCYB) study protocol, a theory-based, tailored print message intervention to improve compliance with the self-care regimen in patients with cardiovascular diseases. A design with a baseline measurement and two follow-ups at six and 12 months will be applied. At baseline and the six-month follow-up, patients will complete self-report questionnaires evaluating lifestyle habits and socio-demographic and psychological variables; at the 12-month follow-up, patients will answer a telephone interview assessing lifestyle habits. After the baseline measurement, patients will be randomized into one of three groups: (1) the tailored group, which will receive tailored health brochures; (2) the ""non-tailored"" group, which will receive non-tailored health brochures; or (3) the usual care group, which will receive no print information materials. The effectiveness of the intervention will be assessed through patients' judgments of the brochures and changes in lifestyle. The role of socio-demographic and psychological variables as potential moderators of the materials' effectiveness will be explored. If the TTCYB is efficacious, it will have implications for the design and implementation of tailored communication programs. Concepts from this study can be potentially extended to primary prevention among high-risk groups.",2020,"If the TTCYB is efficacious, it will have implications for the design and implementation of tailored communication programs.","['patients with cardiovascular diseases', ""Cardiovascular Patients' Lifestyles""]","['tailored health brochures; (2) the ""non-tailored"" group, which will receive non-tailored health brochures; or (3) the usual care group, which will receive no print information materials', 'Tailored Print Message Intervention', 'telephone interview assessing lifestyle habits']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",[],,0.0176912,"If the TTCYB is efficacious, it will have implications for the design and implementation of tailored communication programs.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': ""D'Addario"", 'Affiliation': 'Department of Psychology, University of Milano-Bicocca, 20126 Milan, Italy.'}, {'ForeName': 'Erika Rosa', 'Initials': 'ER', 'LastName': 'Cappelletti', 'Affiliation': 'Health Promotion Division, Agenzia Tutela Salute Milano, 20129 Milan, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Sarini', 'Affiliation': 'Department of Psychology, University of Milano-Bicocca, 20126 Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Greco', 'Affiliation': 'Department of Human and Social Sciences, University of Bergamo, 24129 Bergamo, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Steca', 'Affiliation': 'Department of Psychology, University of Milano-Bicocca, 20126 Milan, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17082919']
17,32340502,Efficacy of transcutaneous electrical acupoint stimulation combined with diazepam for acute alcohol withdrawal syndrome: A double-blind randomized sham-controlled trial.,,2020,,['acute alcohol withdrawal syndrome'],['transcutaneous electrical acupoint stimulation combined with diazepam'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0236663', 'cui_str': 'Alcohol withdrawal syndrome'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}]",[],,0.575961,,"[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Qianfoshan Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'Department of Substance Abuse, Qingdao Mental Health Center, Qingdao, China.'}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': 'Department of Substance Abuse, Qingdao Mental Health Center, Qingdao, China.'}, {'ForeName': 'Cuiluan', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Substance Abuse, Shandong Mental Health Center Affiliated to Jining Medical University, Jinan, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Jian', 'Affiliation': 'Department of Substance Abuse, Shandong Mental Health Center Affiliated to Jining Medical University, Jinan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': 'Department of Substance Abuse, Shandong Mental Health Center Affiliated to Jining Medical University, Jinan, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Substance Abuse, Shandong Mental Health Center Affiliated to Jining Medical University, Jinan, China.'}]",The Journal of international medical research,['10.1177/0300060520910052']
18,32347216,Grinding the intaglio surface of yttria partially- and fully-stabilized zirconia polycrystals restorations: Effect on their fatigue behavior.,"This study evaluated the effects of diamond bur grinding the intaglio surface of second (yttria partially-stabilized zirconia polycrystals, PSZ) and third-generation zirconia (fully-stabilized zirconia polycrystals, FSZ) adhesively cemented to dentin analogue substrate on the fatigue failure load, cycle number until failure, surface micromorphology and phase transformation. Disc-shaped specimens were produced from second (Katana ML-HT, Kuraray) and third-generation zirconia (Katana STML, Kuraray) and randomly allocated (n = 15) into two groups according to the intaglio surface treatment: Control - Ctrl (without grinding); Grinding - Gr (grinding at the center of the intaglio surface). The ceramic discs were adhesively cemented (Multilink Automix System) onto dentin analogue discs. Fatigue tests were executed by the step-stress method. The obtained data were analyzed by Kaplan Meier and Mantel-Cox tests. In addition, surface topography, roughness, phase transformation and fractography analyses were performed. SEM analysis showed that grinding increased the surface roughness and introduced defects in zirconia from both generations. Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 N < grinding: 1600 N), while these same outcomes were reduced by grinding for the third-generation zirconia significantly (control: 766.67 N > grinding: 620 N). Thus, clinical adjustments with diamond burs damage the fatigue behavior of adhesively cemented third-generation zirconia.",2020,"Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 ",[],"['intaglio surface treatment: Control - Ctrl (without grinding); Grinding - Gr (grinding at the center of the intaglio surface', 'diamond bur grinding the intaglio surface of second (yttria partially-stabilized zirconia polycrystals, PSZ) and third-generation zirconia (fully-stabilized zirconia polycrystals, FSZ']","['surface roughness and introduced defects in zirconia', 'Fatigue tests', 'fatigue failure load, number of cycles to failure and survival rates', 'fatigue behavior']",[],"[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0292957', 'cui_str': 'yttria'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0215012,"Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 ","[{'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: camila-svs@hotmail.com.'}, {'ForeName': 'Bruna Dias', 'Initials': 'BD', 'LastName': 'Ilha', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: brunailha2@hotmail.com.'}, {'ForeName': 'Michele Mirian', 'Initials': 'MM', 'LastName': 'May', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: mmayodontologia@gmail.com.'}, {'ForeName': 'Liliana Gressler', 'Initials': 'LG', 'LastName': 'May', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: liligmay@gmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103800']
19,32276820,"Corrigendum to ""Fulfilling the psychological and information need of the family members of critically ill patients using interactive mobile technology: A randomized controlled trial"" [Intensive Crit. Care Nurs. 41 (2017) 77-83].",,2020,,['41'],[],[],[],[],[],,0.108797,,"[{'ForeName': 'Vico Chung Lim', 'Initials': 'VCL', 'LastName': 'Chiang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, HKSAR, PR China. Electronic address: vico.chiang@polyu.edu.hk.'}, {'ForeName': 'Rainbow Lai Ping', 'Initials': 'RLP', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, HKSAR, PR China. Electronic address: rainbow.l.p.lee@polyu.edu.hk.'}, {'ForeName': 'Mei Fung', 'Initials': 'MF', 'LastName': 'Ho', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: hmf430@ha.org.hk.'}, {'ForeName': 'Chi Kwong', 'Initials': 'CK', 'LastName': 'Leung', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: lck504@ha.org.hk.'}, {'ForeName': 'Pui Yi', 'Initials': 'PY', 'LastName': 'Tang', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: tpy336@ha.org.hk.'}, {'ForeName': 'Sze Wing', 'Initials': 'SW', 'LastName': 'Wong', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: wsw449@ha.org.hk.'}, {'ForeName': 'Sin Yee', 'Initials': 'SY', 'LastName': 'Ho', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: hsy446@ha.org.hk.'}, {'ForeName': 'Wai Yan', 'Initials': 'WY', 'LastName': 'Tung', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: twy688a@ha.org.hk.'}, {'ForeName': 'Lai Hang', 'Initials': 'LH', 'LastName': 'Louie', 'Affiliation': 'ICU, North District Hospital, HKSAR, PR China. Electronic address: LLH389@ha.org.hk.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2020.102833']
20,32347764,Air Pollutant Exposure and Stove Use Assessment Methods for the Household Air Pollution Intervention Network (HAPIN) Trial.,"BACKGROUND


High quality personal exposure data is fundamental to understanding the health implications of household energy interventions, interpreting analyses across assigned study arms, and characterizing exposure-response relationships for household air pollution. This paper describes the exposure data collection for the Household Air Pollution Intervention Network (HAPIN), a multicountry randomized controlled trial of liquefied petroleum gas stoves and fuel among 3,200 households in India, Rwanda, Guatemala, and Peru.
OBJECTIVES


The primary objectives of the exposure assessment are to estimate the exposure contrast achieved following a clean fuel intervention and to provide data for analyses of exposure-response relationships across a range of personal exposures.
METHODS


Exposure measurements are being conducted over the 3-y time frame of the field study. We are measuring fine particulate matter [PM  <   2.5 μ m  in aerodynamic diameter ( PM 2.5 )] with the Enhanced Children's MicroPEM™ (RTI International), carbon monoxide (CO) with the USB-EL-CO (Lascar Electronics), and black carbon with the OT21 transmissometer (Magee Scientific) in pregnant women, adult women, and children  < 1   year  of age, primarily via multiple 24-h personal assessments (three, six, and three measurements, respectively) over the course of the 18-month follow-up period using lightweight monitors. For children we are using an indirect measurement approach, combining data from area monitors and locator devices worn by the child. For a subsample (up to 10%) of the study population, we are doubling the frequency of measurements in order to estimate the accuracy of subject-specific typical exposure estimates. In addition, we are conducting ambient air monitoring to help characterize potential contributions of  PM 2.5  exposure from background concentration. Stove use monitors (Geocene) are being used to assess compliance with the intervention, given that stove stacking (use of traditional stoves in addition to the intervention gas stove) may occur.
CONCLUSIONS


The tools and approaches being used for HAPIN to estimate personal exposures build on previous efforts and take advantage of new technologies. In addition to providing key personal exposure data for this study, we hope the application and learnings from our exposure assessment will help inform future efforts to characterize exposure to household air pollution and for other contexts. https://doi.org/10.1289/EHP6422.",2020,"[PM  <   2.5 μ m  in aerodynamic diameter ( PM 2.5 )] with the Enhanced Children's MicroPEM™ (RTI International), carbon monoxide (CO) with the USB-EL-CO (Lascar Electronics), and black carbon with the OT21 transmissometer (Magee Scientific) in pregnant women, adult women, and children  ","['3,200 households in India, Rwanda, Guatemala, and Peru', 'pregnant women, adult women, and children']",['liquefied petroleum gas stoves'],[],"[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}]",[],3200.0,0.0431358,"[PM  <   2.5 μ m  in aerodynamic diameter ( PM 2.5 )] with the Enhanced Children's MicroPEM™ (RTI International), carbon monoxide (CO) with the USB-EL-CO (Lascar Electronics), and black carbon with the OT21 transmissometer (Magee Scientific) in pregnant women, adult women, and children  ","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Johnson', 'Affiliation': 'Berkeley Air Monitoring Group, Berkeley, California, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steenland', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Piedrahita', 'Affiliation': 'Berkeley Air Monitoring Group, Berkeley, California, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Clark', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Pillarisetti', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Luke P', 'Initials': 'LP', 'LastName': 'Naeher', 'Affiliation': 'Department of Environmental Health Science, College of Public Health, University of Georgia, Athens, Georgia, USA.'}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'Geocene, Vallejo, California, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Sarnat', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Lindsay J', 'Initials': 'LJ', 'LastName': 'Underhill', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Burrowes', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'McCracken', 'Affiliation': 'Center for Health Studies, Universidad del Valle de Guatemala, Guatemala City, Guatemala.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Rosa', 'Affiliation': 'Department of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rosenthal', 'Affiliation': 'Division of Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Sankar', 'Initials': 'S', 'LastName': 'Sambandam', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'de Leon', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Miles A', 'Initials': 'MA', 'LastName': 'Kirby', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kearns', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clasen', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environmental health perspectives,['10.1289/EHP6422']
21,32347765,Design and Rationale of the Biomarker Center of the Household Air Pollution Intervention Network (HAPIN) Trial.,"BACKGROUND


Biomarkers of exposure, susceptibility, and effect are fundamental for understanding environmental exposures, mechanistic pathways of effect, and monitoring early adverse outcomes. To date, no study has comprehensively evaluated a large suite and variety of biomarkers in household air pollution (HAP) studies in concert with exposure and outcome data. The Household Air Pollution Intervention Network (HAPIN) trial is a liquified petroleum gas (LPG) fuel/stove randomized intervention trial enrolling 800 pregnant women in each of four countries (i.e., Peru, Guatemala, Rwanda, and India). Their offspring will be followed from birth through 12 months of age to evaluate the role of pre- and postnatal exposure to HAP from biomass burning cookstoves in the control arm and LPG stoves in the intervention arm on growth and respiratory outcomes. In addition, up to 200 older adult women per site are being recruited in the same households to evaluate indicators of cardiopulmonary, metabolic, and cancer outcomes.
OBJECTIVES


Here we describe the rationale and ultimate design of a comprehensive biomarker plan to enable us to explore more fully how exposure is related to disease outcome.
METHODS


HAPIN enrollment and data collection began in May 2018 and will continue through August 2021. As a part of data collection, dried blood spot (DBS) and urine samples are being collected three times during pregnancy in pregnant women and older adult women. DBS are collected at birth for the child. DBS and urine samples are being collected from the older adult women and children three times throughout the child's first year of life. Exposure biomarkers that will be longitudinally measured in all participants include urinary hydroxy-polycyclic aromatic hydrocarbons, volatile organic chemical metabolites, metals/metalloids, levoglucosan, and cotinine. Biomarkers of effect, including inflammation, endothelial and oxidative stress biomarkers, lung cancer markers, and other clinically relevant measures will be analyzed in urine, DBS, or blood products from the older adult women. Similarly, genomic/epigenetic markers, microbiome, and metabolomics will be measured in older adult women samples.
DISCUSSION


Our study design will yield a wealth of biomarker data to evaluate, in great detail, the link between exposures and health outcomes. In addition, our design is comprehensive and innovative by including cutting-edge measures such as metabolomics and epigenetics. https://doi.org/10.1289/EHP5751.",2020,"The Household Air Pollution Intervention Network (HAPIN) trial is a liquified petroleum gas (LPG) fuel/stove randomized intervention trial enrolling 800 pregnant women in each of four countries (i.e., Peru, Guatemala, Rwanda, and India).","['older adult women', 'HAPIN enrollment and data collection began in May 2018 and will continue through August 2021', 'pregnant women and older adult women', '800 pregnant women in each of four countries (i.e., Peru, Guatemala, Rwanda, and India', '200 older adult women per site are being recruited in the same households to evaluate indicators of cardiopulmonary, metabolic, and cancer outcomes', 'older adult women samples']",['https://doi.org/10.1289/EHP5751'],"['DBS and urine samples', 'inflammation, endothelial and oxidative stress biomarkers, lung cancer markers']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",[],"[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]",800.0,0.124554,"The Household Air Pollution Intervention Network (HAPIN) trial is a liquified petroleum gas (LPG) fuel/stove randomized intervention trial enrolling 800 pregnant women in each of four countries (i.e., Peru, Guatemala, Rwanda, and India).","[{'ForeName': 'Dana Boyd', 'Initials': 'DB', 'LastName': 'Barr', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Puttaswamy', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Jaacks', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steenland', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rajkumar', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Savannah', 'Initials': 'S', 'LastName': 'Gupton', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'P Barry', 'Initials': 'PB', 'LastName': 'Ryan', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clasen', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Clark', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environmental health perspectives,['10.1289/EHP5751']
22,32347766,Design and Rationale of the HAPIN Study: A Multicountry Randomized Controlled Trial to Assess the Effect of Liquefied Petroleum Gas Stove and Continuous Fuel Distribution.,"BACKGROUND


Globally, nearly 3 billion people rely on solid fuels for cooking and heating, the vast majority residing in low- and middle-income countries (LMICs). The resulting household air pollution (HAP) is a leading environmental risk factor, accounting for an estimated 1.6 million premature deaths annually. Previous interventions of cleaner stoves have often failed to reduce exposure to levels that produce meaningful health improvements. There have been no multicountry field trials with liquefied petroleum gas (LPG) stoves, likely the cleanest scalable intervention.
OBJECTIVE


This paper describes the design and methods of an ongoing randomized controlled trial (RCT) of LPG stove and fuel distribution in 3,200 households in 4 LMICs (India, Guatemala, Peru, and Rwanda).
METHODS


We are enrolling 800 pregnant women at each of the 4 international research centers from households using biomass fuels. We are randomly assigning households to receive LPG stoves, an 18-month supply of free LPG, and behavioral reinforcements to the control arm. The mother is being followed along with her child until the child is 1 year old. Older adult women (40 to  < 80   years  of age) living in the same households are also enrolled and followed during the same period. Primary health outcomes are low birth weight, severe pneumonia incidence, stunting in the child, and high blood pressure (BP) in the older adult woman. Secondary health outcomes are also being assessed. We are assessing stove and fuel use, conducting repeated personal and kitchen exposure assessments of fine particulate matter with aerodynamic diameter  ≤ 2.5 μ m  ( PM 2.5 ), carbon monoxide (CO), and black carbon (BC), and collecting dried blood spots (DBS) and urinary samples for biomarker analysis. Enrollment and data collection began in May 2018 and will continue through August 2021. The trial is registered with ClinicalTrials.gov (NCT02944682).
CONCLUSIONS


This study will provide evidence to inform national and global policies on scaling up LPG stove use among vulnerable populations. https://doi.org/10.1289/EHP6407.",2020,"Primary health outcomes are low birth weight, severe pneumonia incidence, stunting in the child, and high blood pressure (BP) in the older adult woman.","['800 pregnant women at each of the 4 international research centers from households using biomass fuels', '3,200 households in 4 LMICs (India, Guatemala, Peru, and Rwanda', 'Older adult women (40 to  < 80 \u2009 years  of age) living in the same households are also enrolled and followed during the same period']","['Liquefied Petroleum Gas Stove and Continuous Fuel Distribution', 'LPG stoves', 'LPG stove and fuel distribution']","['low birth weight, severe pneumonia incidence, stunting in the child, and high blood pressure (BP', 'household air pollution (HAP', 'carbon monoxide (CO), and black carbon (BC), and collecting dried blood spots (DBS) and urinary samples for biomarker analysis']","[{'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]","[{'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0007010', 'cui_str': 'Carbon Black'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",800.0,0.14481,"Primary health outcomes are low birth weight, severe pneumonia incidence, stunting in the child, and high blood pressure (BP) in the older adult woman.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clasen', 'Affiliation': 'Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, Tamil Nadu, India.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'McCracken', 'Affiliation': 'Center for Health Studies, Universidad del Valle de Guatemala, Guatemala City, Guatemala.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Rosa', 'Affiliation': 'Department of Disease Control, Faculty of Infections and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Thompson', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Dana Boyd', 'Initials': 'DB', 'LastName': 'Barr', 'Affiliation': 'Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Clark', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Johnson', 'Affiliation': 'Berkeley Air Monitoring Group, Berkeley, California, USA.'}, {'ForeName': 'Lance A', 'Initials': 'LA', 'LastName': 'Waller', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Jaacks', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steenland', 'Affiliation': 'Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Miranda', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Chang', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Dong-Yun', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Office of Biostatistics Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Eudowood Division of Respiratory Sciences, Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Victor G', 'Initials': 'VG', 'LastName': 'Davila-Roman', 'Affiliation': 'Cardiovascular Imaging and Clinical Research Core Laboratory, Cardiovascular Division, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Papageorghiou', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UK.""}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Rosenthal', 'Affiliation': 'Division of Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environmental health perspectives,['10.1289/EHP6407']
23,32348009,The effect of partial pulpotomy with iRoot BP Plus in traumatized immature permanent teeth: A randomized prospective controlled trial.,"BACKGROUND/AIM


A new bioceramic material iRoot BP Plus has been introduced and reported to have good biocompatibility, sealing ability and antibacterial activity. It has also been reported to be successfully used for procedures such as pulpotomy, pulp floor perforation repair and so on. However, there are only a few reports on the use of iRoot BP Plus in the management of traumatized teeth with an exposed pulp. The aim of this study was to investigate the clinical and radiographic outcomes of partial pulpotomy with iRoot BP Plus in immature permanent teeth with complicated crown fracture or complicated crown-root fracture.
MATERIAL AND METHODS


The study was prospectively designed, and 110 immature permanent teeth with complicated crown fracture or complicated crown-root fracture were randomly allocated into two groups (n = 55). All teeth were clinically and radiographically assessed at 1, 3, 6, 12, 18 and 24 months after partial pulpotomy with iRoot BP Plus (experimental group, n = 50) or calcium hydroxide (control group, n = 49) as the pulp capping agent. Eleven cases were lost during follow up, and 99 teeth were finally analysed.
RESULTS


There were no intergroup differences in the survival rate, survival time, root length and dentin wall thickness. The calcific bridge was significantly thinner in the iRoot BP Plus group than in the calcium hydroxide group (0.97 ± 0.13 mm vs 1.36 ± 0.12 mm; F = 5.128, P = .029).
CONCLUSIONS


iRoot BP Plus may be an effective capping material for partial pulpotomy.",2020,"There were no intergroup differences in the survival rate, survival time, root length and dentin wall thickness.","['Traumatised Immature Permanent Teeth', 'immature permanent teeth with complicated crown fracture or complicated crown-root fracture', '110 immature permanent teeth with complicated crown fracture or complicated crown-root fracture']","['calcium hydroxide (control group,n=49) as the pulp capping agent', 'iRoot BP', 'partial pulpotomy with iRoot BP Plus', 'Partial Pulpotomy with iRoot BP Plus', 'calcium hydroxide', 'bioceramic material iRoot BP']","['survival rate, survival time, root length and dentin wall thickness', 'calcific bridge']","[{'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936256', 'cui_str': 'Pulp Capping Agents'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C4043153', 'cui_str': 'iRoot BP Plus'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}]",11.0,0.0477762,"There were no intergroup differences in the survival rate, survival time, root length and dentin wall thickness.","[{'ForeName': 'YingTing', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'The Third Clinical Division of Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xia', 'Affiliation': 'Department of Pediatric Dentistry, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Pediatric Dentistry, The Center for Pediatric Dentistry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Guili', 'Initials': 'G', 'LastName': 'Dou', 'Affiliation': 'Department of Pediatric Dentistry, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'The Third Clinical Division of Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yong', 'Affiliation': 'Department of General Dentistry, Peking University School and Hospital of Stomatology, Beijing, China.'}]",Dental traumatology : official publication of International Association for Dental Traumatology,['10.1111/edt.12563']
24,32343994,Effects of electronic cigarette on platelet and vascular function after four months of use.,"We examined the effects of electronic cigarette on platelet and vascular function after 4 months of use compared to tobacco smoking. Forty smokers without cardiovascular disease were randomized to smoke either conventional cigarettes or an electronic cigarette (nicotine concentration of 12 mg/ml). At baseline and after four months, we measured a) platelet function by Platelet Function Analyzer PFA-100 and Light Transmission Aggregometry, b) pulse wave velocity, c) plasma malondialdehyde levels as oxidative stress index and d) the exhaled CO level. After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045). Conversely, compared to smoking, vaping resulted in greater reduction of exhaled CO (6.9 ppm vs 2.6, p for interaction < 0.001), improvement of PWV (decrease of 0.8 m/s vs increase of 0.8 m/s, p for interaction = 0.020) and reduction of MDA (reduction 0.13 vs increase 0.19 nmol/L, p for interaction = 0.035). Switching to electronic cigarette for 4 months has a neutral effect on platelet function while it reduces arterial stiffness and oxidative stress compared to tobacco smoking.",2020,"After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045).",['Forty smokers without cardiovascular disease'],"['electronic cigarette', 'conventional cigarettes or an electronic cigarette (nicotine concentration of 12\u202fmg/ml']","['exhaled CO', 'platelet function', 'platelet and vascular function', 'improvement of PWV', 'arterial stiffness and oxidative stress', 'reduction of MDA', 'platelet function by Platelet Function Analyzer PFA-100 and Light Transmission Aggregometry, b) pulse wave velocity, c) plasma malondialdehyde levels as oxidative stress index and d) the exhaled CO level']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439294', 'cui_str': 'g/L'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",40.0,0.0199673,"After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: ignoik@gmail.com.""}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Katogiannis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Gavriella', 'Initials': 'G', 'LastName': 'Kostelli', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Kallirhoe', 'Initials': 'K', 'LastName': 'Kourea', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kyriakou', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Kypraiou', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Department of Pharmaceutical Chemistry, National and Kapodistrian University of Athens, School of Pharmacy, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Department of Pharmaceutical Chemistry, National and Kapodistrian University of Athens, School of Pharmacy, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Plotas', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Thymis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Argirios E', 'Initials': 'AE', 'LastName': 'Tsantes', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111389']
25,32344105,The after-effect of noisy galvanic vestibular stimulation on postural control in young people: A randomized controlled trial.,"Noisy galvanic vestibular stimulation (nGVS) enhances the vestibular system. The center of pressure (COP) sway has been shown to decrease during nGVS, but the after-effect of nGVS remains unclear. The aim of this study is to elucidate the after-effect of nGVS on COP sway. We randomly assigned 26 participants to either control (sham stimulation) or nGVS groups. All participants were measured for COP sway while standing with open eyes at baseline, during stimulation, and after stimulation. In the nGVS group, sway path length, mediolateral mean velocity, and anteroposterior mean velocity decreased both during stimulation and after stimulation compared with baseline. Conversely, no significant difference in COP sway was detected in the control group. There was a correlation between the stimulation effect and the after-effect in the nGVS group, indicating that nGVS is effective for people with high baseline COP sway.",2020,"In the nGVS group, sway path length, mediolateral mean velocity, and anteroposterior mean velocity decreased both during stimulation and after stimulation compared with baseline.",['young people'],"['noisy galvanic vestibular stimulation', 'nGVS', 'control (sham stimulation) or nGVS', 'Noisy galvanic vestibular stimulation (nGVS']","['sway path length, mediolateral mean velocity, and anteroposterior mean velocity', 'COP sway', 'postural control']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",26.0,0.0573894,"In the nGVS group, sway path length, mediolateral mean velocity, and anteroposterior mean velocity decreased both during stimulation and after stimulation compared with baseline.","[{'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Inukai', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan. Electronic address: inukai@nuhw.ac.jp.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Otsuru', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Miyaguchi', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Kojima', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Hirotake', 'Initials': 'H', 'LastName': 'Yokota', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Nagasaka', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Onishi', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}]",Neuroscience letters,['10.1016/j.neulet.2020.135009']
26,32345170,Quantitative measurement properties and score interpretation of the Cough Severity Diary in patients with chronic cough.,"AIMS


The Cough Severity Diary (CSD) was developed in accordance with the FDA guidance for patient-reported outcome measures and is focused on capturing the patient's perception of cough in terms of frequency, intensity, and disruption due to their cough. The measure includes a series of seven items asking patients to rate the frequency (three items), intensity (two items), and disruptiveness (two items) of their cough. The instrument was designed to be completed daily before bedtime, has a recall period of 'today,' and responses to items are entered on an 11-point numeric rating scale ranging from 0 to 10 with anchors on each end. The objective of this analysis was to confirm the domain structure of the CSD and assess its reliability, validity, and responsiveness in adult patients with refractory or unexplained chronic cough (RCC/UCC). Criteria for defining meaningful changes in mean weekly CSD total and domain scores in the context of a clinical trial were also developed.
METHODS


Pooled data from a phase II randomized controlled trial of an investigational treatment for RCC/UCC were analyzed. Participants were non-smokers, had RCC/UCC for ⩾1 year, and a baseline cough severity visual analogue scale (VAS) ⩾40 mm. CSD scores (baseline, week 4), were analyzed; the Leicester Cough Questionnaire (LCQ), cough severity VAS, Patient Global Impression of Change (PGIC), and objective cough frequency counts were used for validation. CSD domain structure (Total, Frequency, Intensity, Disruption) was assessed for scoring.
RESULTS


A total of 253 participants were included (mean age 60.2; 76% female). Global fit of the three-factor CSD was acceptable. For the CSD total score, internal consistency (α = 0.89) and test-retest reliability (intraclass correlation coefficient = 0.68) were high. CSD total scores were correlated with the LCQ total ( r  = -0.62) and cough severity VAS ( r  = 0.84). Participants with a PGIC score of 1 or 2 (most improved groups) had the greatest mean score improvement on the CSD Total (Day 0 to Day 28), supporting responsiveness (similar findings for subscales). A change threshold of ⩾1.3-point reduction on the total and subscale scores is appropriate to define clinically meaningful improvement.
CONCLUSION


The CSD is a reliable, valid, and responsive measure of cough symptom severity in patients with refractory or unexplained chronic cough and fit-for-purpose for assessing changes in cough severity in clinical trials.  The reviews of this paper are available via the supplemental material section.",2020,CSD total scores were correlated with the LCQ total ( r  = -0.62) and cough severity VAS ( r  = 0.84).,"['adult patients with refractory or unexplained chronic cough (RCC/UCC', 'patients with refractory or unexplained chronic cough', 'Participants were non-smokers, had RCC/UCC for ⩾1\u2009year, and a baseline cough severity visual analogue scale (VAS) ⩾40\u2009mm', 'patients with chronic cough', 'A total of 253 participants were included (mean age 60.2; 76% female']",[],"['CSD total scores', 'cough severity VAS', 'CSD scores', 'Leicester Cough Questionnaire (LCQ), cough severity VAS, Patient Global Impression of Change (PGIC), and objective cough frequency counts', 'CSD total score, internal consistency', 'Cough Severity Diary (CSD', 'CSD domain structure (Total, Frequency, Intensity, Disruption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4552485', 'cui_str': 'Unexplained chronic cough'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",253.0,0.032168,CSD total scores were correlated with the LCQ total ( r  = -0.62) and cough severity VAS ( r  = 0.84).,"[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Martin Nguyen', 'Affiliation': 'Merck Sharp & Dohme Corp., 770 Sumneytown Pike, West Point, PA 19486 USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bacci', 'Affiliation': 'Evidera Inc, Bethesda, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dicpinigaitis', 'Affiliation': 'Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Vernon', 'Affiliation': 'Evidera Inc, Bethesda, MD, USA.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620915155']
27,32340334,Temperamental Development among Preterm Born Children. An RCT Follow-Up Study.,"A randomized controlled trial study recruited 146 preterm born children, either to participate in a modified version of the Mother-Infant Transaction Program (MITP-m) or to receive the usual follow-up services, before and after discharge from a neonatal intensive care unit. This follow-up study investigates whether MITP participation is associated with parental perceptions of child temperament from two to seven years. Children's temperament was reported by mothers and fathers separately at children's ages of 2, 3, 5, and 7 years. Parents in the MITP-m group reported lower levels of negative emotionality in their children compared to the control group. In maternal reports, a group effect (F(1, 121) = 9.7,  p  = 0.002) revealed a stable difference in children's negative emotionality from two to seven years, while a group-by-time interaction related to an increasing difference was detected in reports from fathers (F(1, 94) = 4.8,  p  = 0.03). Another group difference appeared in fathers' reports of children's soothability (F(1, 100) = 14.2,  p  < 0.0005). MITP-m fathers seemed to perceive their children as easier to soothe at all ages as no interaction with time appeared. Parental reports on children's sociality, shyness, and activity did not differ between the groups.",2020,Parents in the MITP-m group reported lower levels of negative emotionality in their children compared to the control group.,"['Preterm Born Children', '146 preterm born children, either to participate in a modified version of the Mother-Infant Transaction Program (MITP-m) or to receive the usual follow-up services, before and after discharge from a neonatal intensive care unit']",['MITP'],"[""children's sociality, shyness, and activity"", ""children's negative emotionality"", 'levels of negative emotionality', ""fathers' reports of children's soothability""]","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037020', 'cui_str': 'Shyness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0542317', 'cui_str': 'Character trait finding of affective stability'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",146.0,0.0322789,Parents in the MITP-m group reported lower levels of negative emotionality in their children compared to the control group.,"[{'ForeName': 'Inger Pauline', 'Initials': 'IP', 'LastName': 'Landsem', 'Affiliation': 'Child & Adolescent Department, University Hospital of North Norway, 9019 Tromsø, Norway.'}, {'ForeName': 'Bjørn Helge', 'Initials': 'BH', 'LastName': 'Handegård', 'Affiliation': 'Health Research Faculty, UIT the Arctic University of Norway, 9019 Tromsø, Norway.'}, {'ForeName': 'Stein Erik', 'Initials': 'SE', 'LastName': 'Ulvund', 'Affiliation': 'Department of Education, University of Oslo, 0317 Oslo, Norway.'}]","Children (Basel, Switzerland)",['10.3390/children7040036']
28,32340343,"Combined Black Rice Germ, Bran Supplement and Exercise Intervention Modulate Aging Biomarkers and Improve Physical Performance and Lower-Body Muscle Strength Parameters in Aging Population.","Aging is a time-dependent functional decline in muscle mass and strength, which is reflected in poor physical performances, hormonal imbalance, and development of chronic low-grade inflammation. This study aimed to assess the effectiveness of black rice germ, bran supplement, and exercise program either alone or in combination for 24 weeks on the aging biomarkers (C-reactive protein, Interleukin-6, Insulin-like growth factor-1, and CD4:CD8 T cell ratio) physical performance, muscle strength parameters (walking speed, sit-to-stand time, grip strength) among Thai aging population. A total of 120 healthy volunteers aged 65-74 years were assigned to the exercise group (EX), black rice germ, and bran supplement (BR) group or the combination of BR and EX group (BR + EX). Over the course of the 24-week intervention, compared with baseline data (T0), the combined BR + EX intervention significantly decreased the inflammatory biomarkers (C-reactive protein and interleukin-6 levels, both  p  < 0.05 vs. T0) and significantly increased the insulin-like growth factor-1 levels ( p  < 0.001 vs. T0). Significant improvement in physical performance and muscle strength were also observed in the combined BR + EX group (decrease in sit-to-stand time and gait speed over the 24-week intervention, both  p  < 0.05 vs. T0, and trend toward grip strength improvement at  p  = 0.088 vs. T0). Overall, our results indicated a synergistic effect towards the combined intervention with the sustainable improvement in physical performances, lower-body muscle strength, and the modulation of both inflammatory and endocrine biomarkers. This study could encourage older adults to change their lifestyles to improve healthy aging and longevity.",2020,"Significant improvement in physical performance and muscle strength were also observed in the combined BR + EX group (decrease in sit-to-stand time and gait speed over the 24-week intervention, both  p  < 0.05 vs. T0, and trend toward grip strength improvement at  p  = 0.088 vs. T0).","['Thai aging population', 'Aging Population', 'older adults', '120 healthy volunteers aged 65-74 years']","['exercise group (EX), black rice germ, and bran supplement (BR) group or the combination of BR and EX group (BR + EX', 'combined BR + EX', 'black rice germ, bran supplement, and exercise program either alone or in combination', 'Combined Black Rice Germ, Bran Supplement and Exercise Intervention', 'combined BR + EX intervention']","['aging biomarkers (C-reactive protein, Interleukin-6, Insulin-like growth factor-1, and CD4:CD8 T cell ratio) physical performance, muscle strength parameters (walking speed, sit-to-stand time, grip strength', 'sit-to-stand time and gait speed', 'insulin-like growth factor-1 levels', 'grip strength improvement', 'physical performance and muscle strength', 'physical performances, lower-body muscle strength, and the modulation of both inflammatory and endocrine biomarkers', 'inflammatory biomarkers (C-reactive protein and interleukin-6 levels']","[{'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C3257691', 'cui_str': 'Rice germ preparation'}, {'cui': 'C0353942', 'cui_str': 'Bran'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}]",120.0,0.0145485,"Significant improvement in physical performance and muscle strength were also observed in the combined BR + EX group (decrease in sit-to-stand time and gait speed over the 24-week intervention, both  p  < 0.05 vs. T0, and trend toward grip strength improvement at  p  = 0.088 vs. T0).","[{'ForeName': 'Mathuramat', 'Initials': 'M', 'LastName': 'Seesen', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Warathit', 'Initials': 'W', 'LastName': 'Semmarath', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Supachai', 'Initials': 'S', 'LastName': 'Yodkeeree', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Ratana', 'Initials': 'R', 'LastName': 'Sapbamrer', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Pisittawoot', 'Initials': 'P', 'LastName': 'Ayood', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Rungnapa', 'Initials': 'R', 'LastName': 'Malasao', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Krongporn', 'Initials': 'K', 'LastName': 'Ongprasert', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Jiraporn', 'Initials': 'J', 'LastName': 'Chittrakul', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Penprapa', 'Initials': 'P', 'LastName': 'Siviroj', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Pornngarm', 'Initials': 'P', 'LastName': 'Limtrakul Dejkriengkraikul', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17082931']
29,32340367,Evaluation of the French National Program on Home Return of Patients with Chronic Heart Failure (PRADO-IC): Pilot Study of 91 Patients During Its Deployment in the Bas Rhin Area.,"OBJECTIVE


The main objective of this study was to evaluate the impact of the French national program on home return of chronic heart failure patients (PRADO-IC) in terms of re-hospitalizations for heart failure (HF) during its deployment in the Bas-Rhin (France).
PATIENTS AND METHODS


This was a pilot, descriptive, quantitative, retrospective, and bi-centric study (University Hospitals of Strasbourg and Haguenau Hospital Center, France). It included all patients included in the PRADO-IC program from these centers between January 1, 2015 and December 31, 2015. The primary endpoint of our study was the evaluation of the number of 1-year, 6-month, and 30-day re-admissions to the hospital in relation to an acute HF episode, before and after the inclusion of patients in the PRADO-IC program. The secondary endpoints were the number of overall re-hospitalizations (all-cause); the number of days of hospitalization for HF; the time to first re-hospitalization and the average length of hospital stay, before and after inclusion in PRADO-IC; and the overall and cardiovascular mortality rates.
RESULTS


91 patients out of 271 (33,6%) with a mean age of 79.2 years (67-94) were included. They all had chronic HF, essentially class II-III NYHA (90.1%), mostly of ischemic origin (41.9%), with altered left ventricular ejection fraction in 71.4% of cases. A reduction in the mean number of hospitalizations for HF per patient at 30 days, 6 months and 1 year was observed, respectively, from 0.18 ± 0.42 per patient before inclusion to 0.15 ± 0.36 after inclusion (p = 0.56); 0.98 ± 1.04 hospitalizations to 0.53 ± 0.81 at 6 months (p < 0.01); and 1.64 ± 1.14 hospitalizations 1.04 ± 1.05 at 1 year (p < 0.001). Patients were hospitalized less overall after inclusion in the PRADO-IC program. The number of days of hospitalization for HF was reduced after inclusion of patients from 18.02 ± 7.78 days before inclusion to 14.28 ± 11.57 days for the 6 month follow-up (p = 0.006), and from 22.07 ± 10.33 days before inclusion to 16.39 ± 15.94 days for the 1 year follow-up (p < 0.001). In contrast, inclusion in PRADO-IC statistically increased the mean time to first re-hospitalization for HF from mean 99.36 ± 72.39 days before inclusion to 148.11 ± 112.77 days after inclusion (p < 0.001).
CONCLUSION


This study seems to demonstrate that the PRADO-IC program could improve the management of chronic HF patients in ambulatory care, particularly regarding HF re-hospitalization. However, due to the limitations of the methodology used and the small number of patients, it is advisable to consolidate its initial results with a randomized controlled study on a larger number of patients. In our opinion, its results need to be communicated because, to our knowledge, no equivalent study exists.",2020,"A reduction in the mean number of hospitalizations for HF per patient at 30 days, 6 months and 1 year was observed, respectively, from 0.18 ± 0.42 per patient before inclusion to 0.15 ± 0.36 after inclusion (p = 0.56); 0.98 ± 1.04 hospitalizations to 0.53 ± 0.81 at 6 months (p < 0.01); and 1.64 ± 1.14 hospitalizations 1.04 ± 1.05 at 1 year (p < 0.001).","['chronic heart failure patients (PRADO-IC', 'bi-centric study (University Hospitals of Strasbourg and Haguenau Hospital Center, France', 'Patients with Chronic Heart Failure (PRADO-IC', '91 patients out of 271 (33,6%) with a mean age of 79.2 years (67-94) were included', '91 Patients During Its Deployment in the Bas Rhin Area', 'It included all patients included in the PRADO-IC program from these centers between January 1, 2015 and December 31, 2015']","['French National Program', 'French national program']","['number of days of hospitalization for HF', 'mean number of hospitalizations', 'mean time to first re-hospitalization', 'ischemic origin', 'altered left ventricular ejection fraction', 'number of overall re-hospitalizations (all-cause); the number of days of hospitalization for HF; the time to first re-hospitalization and the average length of hospital stay, before and after inclusion in PRADO-IC; and the overall and cardiovascular mortality rates', 'evaluation of the number of 1-year, 6-month, and 30-day re-admissions to the hospital in relation to an acute HF episode']","[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",,0.040552,"A reduction in the mean number of hospitalizations for HF per patient at 30 days, 6 months and 1 year was observed, respectively, from 0.18 ± 0.42 per patient before inclusion to 0.15 ± 0.36 after inclusion (p = 0.56); 0.98 ± 1.04 hospitalizations to 0.53 ± 0.81 at 6 months (p < 0.01); and 1.64 ± 1.14 hospitalizations 1.04 ± 1.05 at 1 year (p < 0.001).","[{'ForeName': 'Mylène', 'Initials': 'M', 'LastName': 'Radreau', 'Affiliation': 'Service de Médecine Interne, Diabète et Maladies Métaboliques, Clinique Médicale B, Hôpitaux Universitaires de Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Lorenzo-Villalba', 'Affiliation': 'Service de Médecine Interne, Diabète et Maladies Métaboliques, Clinique Médicale B, Hôpitaux Universitaires de Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Talha', 'Affiliation': ""Service de Physiologie et Laboratoire d'Explorations Fonctionnelles, Hôpitaux Universitaires de Strasbourg, 67000 Strasbourg, France.""}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Von Hunolstein', 'Affiliation': ""Service de Cardiologie, Unité Fonctionnelle dédiée à l'insuffisance cardiaque, Pôle Médico-chirurgical de Cardiovasculaire, Hôpitaux Universitaires de Strasbourg, 67000 Strasbourg, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Hanssen', 'Affiliation': 'Service de Cardiologie, Centre Hospitalier de Haguenau, 67500 Haguenau, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Koenig', 'Affiliation': ""Service de Cardiologie, Unité Fonctionnelle dédiée à l'insuffisance cardiaque, Pôle Médico-chirurgical de Cardiovasculaire, Hôpitaux Universitaires de Strasbourg, 67000 Strasbourg, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Couppie', 'Affiliation': 'Service de Cardiologie, Centre Hospitalier de Haguenau, 67500 Haguenau, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Geny', 'Affiliation': ""Service de Physiologie et Laboratoire d'Explorations Fonctionnelles, Hôpitaux Universitaires de Strasbourg, 67000 Strasbourg, France.""}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Severac', 'Affiliation': ""Département de santé publique et d'épidémiologie, Hôpitaux Universitaires de Strasbourg, 67000 Strasbourg, France.""}, {'ForeName': 'Gérald', 'Initials': 'G', 'LastName': 'Roul', 'Affiliation': ""Service de Cardiologie, Unité Fonctionnelle dédiée à l'insuffisance cardiaque, Pôle Médico-chirurgical de Cardiovasculaire, Hôpitaux Universitaires de Strasbourg, 67000 Strasbourg, France.""}, {'ForeName': 'Abrar-Ahmad', 'Initials': 'AA', 'LastName': 'Zulfiqar', 'Affiliation': 'Service de Médecine Interne, Diabète et Maladies Métaboliques, Clinique Médicale B, Hôpitaux Universitaires de Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Andrès', 'Affiliation': 'Service de Médecine Interne, Diabète et Maladies Métaboliques, Clinique Médicale B, Hôpitaux Universitaires de Strasbourg, 67000 Strasbourg, France.'}]",Journal of clinical medicine,['10.3390/jcm9041222']
30,32340375,Effect of Increased Daily Water Intake and Hydration on Health in Japanese Adults.,"Increased hydration is recommended as healthy habit with several merits. However, supportive data are sparse. To assess the efficacy of increased daily water intake, we tested the effect of water supplementation on biomarkers in blood, urine, and saliva. Twenty-four healthy Japanese men and 31 healthy Japanese women with fasting blood glucose levels ranging from 90-125 mg/dL were included. An open-label, two-arm, randomized controlled trial was conducted for 12 weeks. Two additional 550 mL bottles of water on top of habitual fluid intake were consumed in the intervention group. The subjects drank one bottle of water (550 mL) within 2 h of waking, and one bottle (550 mL) 2 h before bedtime. Subjects increased mean fluid intake from 1.3 L/day to 2.0 L/day, without changes in total energy intake. Total body water rate increased with associated water supplementation. There were no significant changes in fasting blood glucose and arginine vasopressin levels, but systolic blood pressure was significantly decreased in the intervention group. Furthermore, water supplementation increased body temperature, reduced blood urea nitrogen concentration, and suppressed estimated glomerular filtration rate reduction. Additionally, existence of an intestinal microbiome correlated with decreased systolic blood pressure and increased body temperature. Habitual water supplementation after waking up and before bedtime in healthy subjects with slightly elevated fasting blood glucose levels is not effective in lowering these levels. However, it represents a safe and promising intervention with the potential for lowering blood pressure, increasing body temperature, diluting blood waste materials, and protecting kidney function. Thus, increasing daily water intake could provide several health benefits.",2020,"There were no significant changes in fasting blood glucose and arginine vasopressin levels, but systolic blood pressure was significantly decreased in the intervention group.","['healthy subjects', 'Twenty-four healthy Japanese men and 31 healthy Japanese women with fasting blood glucose levels ranging from 90-125 mg/dL were included', 'Japanese Adults']","['Habitual water supplementation', 'Increased Daily Water Intake and Hydration', 'water supplementation']","['mean fluid intake', 'biomarkers in blood, urine, and saliva', 'body temperature, reduced blood urea nitrogen concentration', 'total energy intake', 'systolic blood pressure and increased body temperature', 'Total body water rate', 'systolic blood pressure', 'glomerular filtration rate reduction', 'fasting blood glucose and arginine vasopressin levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",24.0,0.0273587,"There were no significant changes in fasting blood glucose and arginine vasopressin levels, but systolic blood pressure was significantly decreased in the intervention group.","[{'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Suntory Global Innovation Center Ltd. Research Institute, 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Watanabe', 'Affiliation': 'Suntory Global Innovation Center Ltd. Research Institute, 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Medical Management and Informatics, Hokkaido Information University, Nishi-Nopporo 59-2, Ebetsu, Hokkaido 069-8585, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Yasui', 'Affiliation': 'Department of Pharmacology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Nishihira', 'Affiliation': 'Department of Medical Management and Informatics, Hokkaido Information University, Nishi-Nopporo 59-2, Ebetsu, Hokkaido 069-8585, Japan.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Murayama', 'Affiliation': 'Suntory Global Innovation Center Ltd. Research Institute, 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan.'}]",Nutrients,['10.3390/nu12041191']
31,32347815,The Development and Evaluation of a Text Message Program to Prevent Perceived Insufficient Milk Among First-Time Mothers: Retrospective Analysis of a Randomized Controlled Trial.,"BACKGROUND


Several recent trials have examined the feasibility and efficacy of automated SMS text messaging to provide remote breastfeeding support to mothers, but these texting systems vary in terms of design features and outcomes examined.
OBJECTIVE


This study examined user engagement with and feedback on a theory-grounded SMS text messaging intervention intended to prevent perceived insufficient milk (PIM)-the single, leading modifiable cause of unintended breastfeeding reduction and cessation.
METHODS


We recruited 250 nulliparous individuals intending to breastfeed between 13 and 25 weeks of pregnancy in southwestern Pennsylvania. Participants were randomly assigned with equal allocation to either an SMS intervention to prevent PIM and unintended breastfeeding reduction or cessation (MILK, a Mobile, semiautomated text message-based Intervention to prevent perceived Low or insufficient milK supply; n=126) or a control group receiving general perinatal SMS text messaging-based support via the national, free Text4Baby system (n=124). Participants in both groups received SMS text messages 3 to 7 times per week from 25 weeks of pregnancy to 8 weeks postpartum. The MILK intervention incorporated several automated interactivity and personalization features (eg, keyword texting for more detailed information on topics and branched response logic) as well as an option to receive one-on-one assistance from an on-call study lactation consultant. We examined participant interactions with the MILK system, including response rates to SMS text messaging queries. We also sought participant feedback on MILK content, delivery preferences, and overall satisfaction with the system via interviews and a remote survey at 8 weeks postpartum.
RESULTS


Participants randomized to MILK (87/124, 70.2% white and 84/124, 67.7% college educated) reported that MILK texts increased their breastfeeding confidence and helped them persevere through breastfeeding problems. Of 124 participants, 9 (7.3%) elected to stop MILK messages, and 3 (2.4%) opted to reduce message frequency during the course of the study. There were 46 texts through the MILK system for individualized assistance from the study lactation consultant (25/46, 54% on weekends or after-hours). The most commonly texted keywords for more detailed information occurred during weeks 4 to 6 postpartum and addressed milk volume intake and breastfeeding and sleep patterns. MILK participants stated a preference for anticipatory guidance on potential breastfeeding issues and less content addressing the benefits of breastfeeding. Suggested improvements included extending messaging past 8 weeks, providing access to messaging for partners, and tailoring content based on participants' pre-existing breastfeeding knowledge and unique breastfeeding trajectory.
CONCLUSIONS


Prenatal and postpartum evidence-based breastfeeding support delivered via semiautomated SMS text messaging is a feasible and an acceptable intervention for first-time mothers. To optimize engagement with digital breastfeeding interventions, enhanced customization features should be considered.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02724969; https://clinicaltrials.gov/ct2/show/NCT02724969.",2020,"Participants were randomly assigned with equal allocation to either an SMS intervention to prevent PIM and unintended breastfeeding reduction or cessation (MILK, a Mobile, semiautomated text message-based Intervention to prevent perceived Low or insufficient milK supply; n=126) or a control group receiving general perinatal SMS text messaging-based support via the national, free Text4Baby system (n=124).","['Of 124 participants, 9 (7.3%) elected to stop MILK messages, and 3 (2.4%) opted to reduce message frequency during the course of the study', '250 nulliparous individuals intending to breastfeed between 13 and 25 weeks of pregnancy in southwestern Pennsylvania']","['MILK', 'automated SMS text messaging', 'MILK intervention', 'SMS text messages', 'SMS intervention to prevent PIM and unintended breastfeeding reduction or cessation (MILK, a Mobile, semiautomated text message-based Intervention to prevent perceived Low or insufficient milK supply; n=126) or a control group receiving general perinatal SMS text messaging-based support via the national, free Text4Baby system']","['MILK content, delivery preferences, and overall satisfaction', 'MILK texts increased their breastfeeding confidence and helped them persevere through breastfeeding problems']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",250.0,0.113473,"Participants were randomly assigned with equal allocation to either an SMS intervention to prevent PIM and unintended breastfeeding reduction or cessation (MILK, a Mobile, semiautomated text message-based Intervention to prevent perceived Low or insufficient milK supply; n=126) or a control group receiving general perinatal SMS text messaging-based support via the national, free Text4Baby system (n=124).","[{'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Demirci', 'Affiliation': 'Department of Health Promotion & Development, University of Pittsburgh School of Nursing, Pittsburgh, PA, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Doman', 'Affiliation': 'Office of Academic Computing, Western Psychiatric Institute and Clinic, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Glasser', 'Affiliation': 'Department of Health Promotion & Development, University of Pittsburgh School of Nursing, Pittsburgh, PA, United States.'}, {'ForeName': 'Judy C', 'Initials': 'JC', 'LastName': 'Chang', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, and Internal Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'Department of Health & Community Systems, Center for Research and Evaluation, University of Pittsburgh School of Nursing, Pittsburgh, PA, United States.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Bogen', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.""}]",JMIR mHealth and uHealth,['10.2196/17328']
32,32344176,Imagining a positive future reduces cortisol response to awakening and reactivity to acute stress.,"The positive influence of optimism on health is thought to be due in part to a reduced physiological response to stress, as manifested for instance in activity of hypothalamic-pituitary-adrenal (HPA) systems. Results of previous studies support the notion that dispositional optimism can influence diurnal cortisol secretion as well as cortisol reactivity. The aim of the present study was to examine whether induced optimism can similarly affect HPA activity and thereby potentially have beneficial health effects. We assigned 66 university students to either the Best Possible Self (BPS) or an active control condition, respectively entailing two weeks of daily visualization of a positive future or time management exercises. Before and after the intervention, we assessed diurnal cortisol levels, response to awakening (CAR), and reactivity to the Trier Social Stress Task (TSST), as well as optimism, affect, negative cognitions, perceived stress, and threat appraisal. Effects of the BPS intervention were tested with repeated measures ANOVA (psychological outcomes) and multilevel regression (cortisol outcomes). The BPS intervention was associated with decreases in both the CAR and cortisol responses to acute stress. Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism. Within-person decreases in worrying were associated with decreased CARs, whereas both decreased worrying and increased PA were linked to attenuated stress reactivity. Results suggest that the BPS intervention can influence HPA axis reactivity, with effects on well-being variables likely mediating the process. More research is needed to determine longer-term neuroendocrine and health effects of such interventions in at-risk as well as healthy populations.",2020,"Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism.",['66 university students to either the'],"['BPS intervention', 'Best Possible Self (BPS) or an active control condition, respectively entailing two weeks of daily visualization of a positive future or time management exercises']","['optimism', 'CAR and cortisol responses', 'cortisol response', 'diurnal cortisol levels, response to awakening (CAR), and reactivity to the Trier Social Stress Task (TSST), as well as optimism, affect, negative cognitions, perceived stress, and threat appraisal', 'HPA axis reactivity', 'HPA activity', 'diurnal cortisol secretion']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",66.0,0.0181314,"Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism.","[{'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Nicolson', 'Affiliation': 'Department of Psychiatry & Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands. Electronic address: n.nicolson@maastrichtuniversity.nl.'}, {'ForeName': 'Madelon L', 'Initials': 'ML', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands. Electronic address: madelon.peters@maastrichtuniversity.nl.'}, {'ForeName': 'Yvo M C', 'Initials': 'YMC', 'LastName': 'In den Bosch-Meevissen', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands. Electronic address: info@MindMotions.nl.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104677']
33,32344198,Ileo-colonic delivery of conjugated bile acids improves glucose homeostasis via colonic GLP-1-producing enteroendocrine cells in human obesity and diabetes.,"BACKGROUND


The bile acid (BA) pathway plays a role in regulation of food intake and glucose metabolism, based mainly on findings in animal models. Our aim was to determine whether the BA pathway is altered and correctable in human obesity and diabetes.
METHODS


We conducted 3 investigations: 1) BA receptor pathways were studied in NCI-H716 enteroendocrine cell (EEC) line, whole human colonic mucosal tissue and in human colonic EEC isolated by Fluorescence-activated Cell Sorting (ex vivo) from endoscopically-obtained biopsies colon mucosa; 2) We characterized the BA pathway in 307 participants by measuring during fasting and postprandial levels of FGF19, 7αC4 and serum BA; 3) In a placebo-controlled, double-blind, randomised, 28-day trial, we studied the effect of ileo-colonic delivery of conjugated BAs (IC-CBAS) on glucose metabolism, incretins, and lipids, in participants with obesity and diabetes.
FINDINGS


Human colonic GLP-1-producing EECs express TGR5, and upon treatment with bile acids in vitro, human EEC differentially expressed GLP-1 at the protein and mRNA level. In Ussing Chamber, GLP-1 release was stimulated by Taurocholic acid in either the apical or basolateral compartment. FGF19 was decreased in obesity and diabetes compared to controls. When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide. Increase in faecal BA was associated with weight loss and with decreased fructosamine.
INTERPRETATIONS


In humans, BA signalling machinery is expressed in colonic EECs, deficient in obesity and diabetes, and when stimulated with IC-CBAS, improved glucose homeostasis. ClinicalTrials.gov number, NCT02871882, NCT02033876.
FUNDING


Research support and drug was provided by Satiogen Pharmaceuticals (San Diego, CA). AA, MC, and NFL report grants (AA- C-Sig P30DK84567, K23 DK114460; MC- NIH R01 DK67071; NFL- R01 DK057993) from the NIH. JR was supported by an Early Career Grant from Society for Endocrinology.",2020,"When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide.","['human obesity and diabetes', 'participants with obesity and diabetes', '307 participants by measuring during fasting and postprandial levels of FGF19, 7αC4 and serum BA; 3) In a']","['placebo, IC-CBAS', 'conjugated bile acids', 'ileo-colonic delivery of conjugated BAs (IC-CBAS', 'FGF19', 'placebo']","['glucose homeostasis', 'weight loss', 'faecal BA', 'obesity and diabetes', 'postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025922', 'cui_str': 'Mouse, Inbred CBA'}, {'cui': 'C0443599', 'cui_str': 'Conjugated bile acids'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}]",307.0,0.064704,"When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide.","[{'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Calderon', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McRae', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Juraj', 'Initials': 'J', 'LastName': 'Rievaj', 'Affiliation': 'University of Cambridge, UK; Current affiliation: Dosage Form Design & Development, AstraZeneca Granta Park, Cambridge CB21 6GH, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Inuk', 'Initials': 'I', 'LastName': 'Zandvakili', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Linker-Nord', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Burton', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'Current affiliation: Dosage Form Design & Development, AstraZeneca Granta Park, Cambridge CB21 6GH, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Reimann', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'Bronislava', 'Initials': 'B', 'LastName': 'Gedulin', 'Affiliation': 'Satiogen Pharmaceuticals, San Diego, CA, United States.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Vella', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'LaRusso', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Gribble', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Acosta', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States. Electronic address: acosta.andres@mayo.edu.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102759']
34,32344201,Continuous postoperative pericardial flushing method versus standard care for wound drainage after adult cardiac surgery: A randomized controlled trial.,"BACKGROUND


Excessive bleeding, incomplete wound drainage, and subsequent accumulation of blood and clots in the pericardium have been associated with a broad spectrum of bleeding-related complications after cardiac surgery. We developed and studied the continuous postoperative pericardial flushing (CPPF) method to improve wound drainage and reduce blood loss and bleeding-related complications.
METHODS


We conducted a single-center, open-label, ITT, randomized controlled trial at the Academic Medical Center Amstserdam. Adults undergoing cardiac surgery for non-emergent valvular or congenital heart disease (CHD) were randomly assigned (1:1) to receive CPPF method or standard care. The primary outcome was actual blood loss after 12-hour stay in the intensive care unit (ICU). Secondary outcomes included bleeding-related complications and clinical outcome after six months follow-up.
FINDINGS


Between May 2013 and February 2016, 170 patients were randomly allocated to CPPF method (study group; n = 80) or to standard care (control group; n = 90). CPPF significantly reduced blood loss after 12-hour stay in the ICU (-41%) when compared to standard care (median differences -155 ml, 95% confidence interval (CI) -310 to 0; p=≤0·001). Cardiac tamponade and reoperation for bleeding did not occur in the study group versus one and three in the control group, respectively. At discharge from hospital, patients in the study group were less likely to have pleural effusion in a surgically opened pleural cavity (22% vs. 36%; p = 0·043).
INTERPRETATION


Our study results indicate that CPPF is a safe and effective method to improve chest tube patency and reduce blood loss after cardiac surgery. Larger trials are needed to draw final conclusions concerning the effectiveness of CPPF on clinically relevant outcomes.",2020,"Cardiac tamponade and reoperation for bleeding did not occur in the study group versus one and three in the control group, respectively.","['wound drainage after adult cardiac surgery', 'Between May 2013 and February 2016, 170 patients', 'Adults undergoing cardiac surgery for non-emergent valvular or congenital heart disease (CHD']","['CPPF', 'CPPF method or standard care', 'Continuous postoperative pericardial flushing method versus standard care', 'CPPF method (study group; n\u202f=\u202f80) or to standard care (control group; n\u202f=\u202f90']","['actual blood loss after 12-hour stay in the intensive care unit (ICU', 'Cardiac tamponade and reoperation for bleeding', 'pleural effusion', 'bleeding-related complications and clinical outcome after six months follow-up', 'blood loss']","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442031', 'cui_str': 'Pericardial'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0553700', 'cui_str': 'Actual blood loss'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0007177', 'cui_str': 'Cardiac tamponade'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",170.0,0.171937,"Cardiac tamponade and reoperation for bleeding did not occur in the study group versus one and three in the control group, respectively.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Diephuis', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. Electronic address: e.c.diephuis@amsterdamumc.nl.'}, {'ForeName': 'Corianne', 'Initials': 'C', 'LastName': 'de Borgie', 'Affiliation': 'Clinical Research Unit, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Tomšič', 'Affiliation': 'Department of Cardiothoracic Surgery, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Winkelman', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Wim Jan', 'Initials': 'WJ', 'LastName': 'van Boven', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Berto', 'Initials': 'B', 'LastName': 'Bouma', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Eberl', 'Affiliation': 'Department of Anesthesiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Juffermans', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Schultz', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Jose P', 'Initials': 'JP', 'LastName': 'Henriques', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Koolbergen', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands; Department of Cardiothoracic Surgery, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102744']
35,32352391,Multidimensional Cognitive Behavioral Therapy for Obesity Applied by Psychologists Using a Digital Platform: Open-Label Randomized Controlled Trial.,"BACKGROUND


Developing effective, widely useful, weight management programs is a priority in health care because obesity is a major health problem.
OBJECTIVE


This study developed and investigated a new, comprehensive, multifactorial, daily, intensive, psychologist coaching program based on cognitive behavioral therapy (CBT) modules. The program was delivered via the digital health care mobile services Noom Coach and InBody.
METHODS


This was an open-label, active-comparator, randomized controlled trial. A total of 70 female participants with BMI scores above 24 kg/m 2  and no clinical problems besides obesity were randomized into experimental and control groups. The experimental (ie, digital CBT) group (n=45) was connected with a therapist intervention using a digital health care service that provided daily feedback and assignments for 8 weeks. The control group (n=25) also used the digital health care service, but practiced self-care without therapist intervention. The main outcomes of this study were measured objectively at baseline, 8 weeks, and 24 weeks and included weight (kg) as well as other body compositions. Differences between groups were evaluated using independent t tests and a per-protocol framework.
RESULTS


Mean weight loss at 8 weeks in the digital CBT group was significantly higher than in the control group (-3.1%, SD 4.5, vs -0.7%, SD 3.4, P=.04). Additionally, the proportion of subjects who attained conventional 5% weight loss from baseline in the digital CBT group was significantly higher than in the control group at 8 weeks (32% [12/38] vs 4% [1/21], P=.02) but not at 24 weeks. Mean fat mass reduction in the digital CBT group at 8 weeks was also significantly greater than in the control group (-6.3%, SD 8.8, vs -0.8%, SD 8.1, P=.02). Mean leptin and insulin resistance in the digital CBT group at 8 weeks was significantly reduced compared to the control group (-15.8%, SD 29.9, vs 7.2%, SD 35.9, P=.01; and -7.1%, SD 35.1, vs 14.4%, SD 41.2, P=.04). Emotional eating behavior (ie, mean score) measured by questionnaire (ie, the Dutch Eating Behavior Questionnaire) at 8 weeks was significantly improved compared to the control group (-2.8%, SD 34.4, vs 21.6%, SD 56.9, P=.048). Mean snack calorie intake in the digital CBT group during the intervention period was significantly lower than in the control group (135.9 kcal, SD 86.4, vs 208.2 kcal, SD 166.3, P=.02). Lastly, baseline depression, anxiety, and self-esteem levels significantly predicted long-term clinical outcomes (24 weeks), while baseline motivation significantly predicted both short-term (8 weeks) and long-term clinical outcomes.
CONCLUSIONS


These findings confirm that technology-based interventions should be multidimensional and are most effective with human feedback and support. This study is innovative in successfully developing and verifying the effects of a new CBT approach with a multidisciplinary team based on digital technologies rather than standalone technology-based interventions.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03465306; https://clinicaltrials.gov/ct2/show/NCT03465306.",2020,"Mean snack calorie intake in the digital CBT group during the intervention period was significantly lower than in the control group (135.9 kcal, SD 86.4, vs 208.2 kcal, SD 166.3, P=.02).","['70 female participants with BMI scores above 24 kg/m 2  and no clinical problems besides obesity', 'Obesity']","['Multidimensional Cognitive Behavioral Therapy', 'digital health care service, but practiced self-care without therapist intervention', 'Digital Platform']","['Mean fat mass reduction', 'Emotional eating behavior', 'Mean weight loss', 'Mean leptin and insulin resistance', 'weight loss', 'Mean snack calorie intake', 'Lastly, baseline depression, anxiety, and self-esteem levels', 'questionnaire (ie, the Dutch Eating Behavior Questionnaire', 'weight (kg) as well as other body compositions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",70.0,0.113484,"Mean snack calorie intake in the digital CBT group during the intervention period was significantly lower than in the control group (135.9 kcal, SD 86.4, vs 208.2 kcal, SD 166.3, P=.02).","[{'ForeName': 'Meelim', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Youngin', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Noom Inc, New York City, NY, United States.'}, {'ForeName': 'Yoonjeong', 'Initials': 'Y', 'LastName': 'Go', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seokoh', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Myeongjin', 'Initials': 'M', 'LastName': 'Na', 'Affiliation': ""Department of Psychology, Duksung Women's University, Ssangmun-Dong, Dobong-Gu, Republic of Korea.""}, {'ForeName': 'Younghee', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sungwon', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': ""Department of Psychology, Duksung Women's University, Ssangmun-Dong, Dobong-Gu, Republic of Korea.""}, {'ForeName': 'Hyung Jin', 'Initials': 'HJ', 'LastName': 'Choi', 'Affiliation': 'Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]",JMIR mHealth and uHealth,['10.2196/14817']
36,32352393,Effects of Sharing Old Pictures With Grandchildren on Intergenerational Relationships: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Intergenerational relationships are beneficial for both grandparents and grandchildren. A positive grandparent-grandchild relationship can improve the psychological well-being of older adults and be a source of social support, family history, and identity development. Maintaining meaningful interactions can be, however, a challenging endeavor, especially as life events lead to relocating geographically. Grandparents and grandchildren can have different preferences in terms of communication mediums and different assumptions about the real conversational needs of the other.
OBJECTIVE


In this study, we will investigate the feasibility and effect of sharing memories of older adults with their grandchildren in social media. This intervention focuses on bringing snippets of the lives of the grandparents into the grandchildren's social media feed and analyzing the potential effect on relational quality, relational investment, and conversational resources from the perspective of the grandchildren.
METHODS


A randomized controlled trial will be used to measure the effectiveness of sharing family memories through social media on intergenerational relationships from the perspective of the grandchildren. The study will be implemented in Mongolia among 60 grandparent-grandchild pairs who will be assigned to either a control or intervention group. Pictures and stories will be collected during reminiscence sessions between the researchers and the grandparents before the intervention. During an intervention period of 2 months, grandchildren in the intervention group will receive pictures and stories of their grandparents on their social media account. Pre- and postintervention questionnaires will measure relationship quality, relationship investment, and conversational resources and will be used to assess the effectiveness of the intervention.
RESULTS


We conducted a pretest pilot from January to April 2018 among 6 pairs of participants (6 grandparents and 6 grandchildren). The validation of the protocol was focused on the process, instruments, and technological setup. We continued the study after the validation, and 59 pairs of participants (59 grandparents and 59 grandchildren) have been recruited. The data collection was completed in November 2019.
CONCLUSIONS


The results of this study will contribute to strategies to stimulate social interactions in intergenerational pairs. A validation of the study process is also presented to provide further operational recommendations. The lessons learned during the validation of the protocol are discussed with recommendations and implications for the recruitment, reminiscence sessions, technological setup, and administration of instruments.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16315.",2020,"Grandparents and grandchildren can have different preferences in terms of communication mediums and different assumptions about the real conversational needs of the other.
","['older adults with their grandchildren in social media', 'Mongolia among 60 grandparent-grandchild pairs who will be assigned to either a control or intervention group', '59 pairs of participants (59 grandparents and 59 grandchildren) have been recruited', 'pretest pilot from January to April 2018 among 6 pairs of participants (6 grandparents and 6 grandchildren']",['Sharing Old Pictures'],"['relationship quality, relationship investment, and conversational resources', 'relational quality, relational investment, and conversational resources']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0026410', 'cui_str': 'Mongolia'}, {'cui': 'C0337471', 'cui_str': 'Grandparent'}, {'cui': 'C0337548', 'cui_str': 'Grandchild'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021953', 'cui_str': 'Investments'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",,0.0396629,"Grandparents and grandchildren can have different preferences in terms of communication mediums and different assumptions about the real conversational needs of the other.
","[{'ForeName': 'Zoljargalan', 'Initials': 'Z', 'LastName': 'Gantumur', 'Affiliation': 'School of Public Health, Mongolian National University of Medical Sciences, Ulaanbaatar, Mongolia.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Baez', 'Affiliation': 'University of Trento, Povo (TN), Italy.'}, {'ForeName': 'Nomin-Erdene', 'Initials': 'NE', 'LastName': 'Ulamnemekh', 'Affiliation': 'School of Public Health, Mongolian National University of Medical Sciences, Ulaanbaatar, Mongolia.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ibarra', 'Affiliation': 'University of Trento, Povo (TN), Italy.'}, {'ForeName': 'Sugarmaa', 'Initials': 'S', 'LastName': 'Myagmarjav', 'Affiliation': 'School of Public Health, Mongolian National University of Medical Sciences, Ulaanbaatar, Mongolia.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Casati', 'Affiliation': 'University of Trento, Povo (TN), Italy.'}]",JMIR research protocols,['10.2196/16315']
37,32348960,Sacubitril/valsartan increases postprandial gastrin and cholecystokinin in plasma.,"Aims


Neprilysin degrades natriuretic peptides in circulation and is also suggested to degrade the gut hormones gastrin and cholecystokinin. Neprilysin inhibition has become a therapeutic strategy and thus a regimen in need of further testing in terms of other hormonal axes besides natriuretic peptides. The aim of this study was to examine whether acute inhibition of neprilysin affects meal-induced responses in gastrin and cholecystokinin concentrations in healthy individuals.
Methods and results


Nine healthy young men were included in an open-labelled, randomized cross-over clinical trial. The participants received a standardized meal (25 g fat, 26 g protein, 42 g carbohydrate) on two separate days with or without a one-time dosage of sacubitril ((194 mg)/valsartan (206 mg)). Blood pressure, heart rate and blood samples were measured and collected during the experiment. Statistical differences between groups were assessed using area under the curve together with an ANOVA with a Bonferroni post hoc test. Sacubitril/valsartan increased the postprandial plasma concentrations of both gastrin and cholecystokinin (80% (AUC0-270 min, P = 0.004) and 60% (AUC0-270 min, P = 0.003), respectively) compared with the control meal. No significant hemodynamic effects were noted (blood pressure, AUC0-270 min, P = 0.86, heart rate, AUC0-270 min, P = 0.96).
Conclusion


Our study demonstrates that sacubitril/valsartan increases the postprandial plasma concentrations of gastrin and cholecystokinin in healthy individuals. The results thus suggest that neprilysin-mediated degradation of gastrin and cholecystokinin is physiologically relevant and may have a role in heart failure patients treated with sacubitril/valsartan.",2020,"No significant hemodynamic effects were noted (blood pressure, AUC0-270 min, P = 0.86, heart rate, AUC0-270 min, P = 0.96).
","['Nine healthy young men', 'heart failure patients treated with', 'healthy individuals']","['standardized meal', 'Sacubitril/valsartan', 'sacubitril/valsartan']","['Blood pressure, heart rate and blood samples', 'postprandial plasma concentrations of both gastrin and cholecystokinin', 'gastrin and cholecystokinin concentrations', 'postprandial plasma concentrations of gastrin and cholecystokinin', 'postprandial gastrin and cholecystokinin in plasma', 'hemodynamic effects']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017151', 'cui_str': 'Gastrins'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",9.0,0.0323268,"No significant hemodynamic effects were noted (blood pressure, AUC0-270 min, P = 0.86, heart rate, AUC0-270 min, P = 0.96).
","[{'ForeName': 'Ulrik Ø', 'Initials': 'UØ', 'LastName': 'Andersen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Dijana', 'Initials': 'D', 'LastName': 'Terzic', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai Jacob', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dall Mark', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Plomgaard', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jens P', 'Initials': 'JP', 'LastName': 'Goetze', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}]",Endocrine connections,['10.1530/EC-19-0563']
38,32350650,"Consideration of eyeball length and prismatic side-effects of spectacle lenses in strabismus surgery-a randomised, double-blind interventional study.","PURPOSE


Potential sources of error in dosage planning in strabismus surgery are (a) prismatic side-effects of spectacle lenses when measuring the preoperative angle with the alternating prism cover test and (b) a potential influence of eye ball axial length on dose response. As both errors take effect in opposite directions, many strabismus surgeons set aside their consideration. This study investigates whether considering both factors for dosage planning yields better operative results.
METHODS


In this prospective, randomised, double-blind, interventional pilot study, we included patients scheduled for purely horizontal strabismus surgery and determined each patient's surgical dose (total amount of recession/plication) either with (study group) or without (control) consideration of the two factors. The deviation of the resulting angle from the target angle 3 months postoperatively was the primary endpoint.
RESULTS


One hundred one patients were included, 51 of which in the intervention group and 50 in the control group. The primary endpoint showed a median deviation from the target of 3.0° in the intervention group and 4.8° in the control group. We observed a group difference of 1.8° in favour of the intervention group (p = 0.053). Subgroup analysis showed a difference between groups of 2.2° for esotropic patients and of 5.1° for patients with hyperopia > + 2 D.
CONCLUSION


Taking prismatic side-effects of spectacle lenses and eye ball length into account when calculating strabismus surgery doses showed a trend towards more accurate results. Esotropic patients and patients with hyperopia > + 2 D seemed to benefit most.
TRIAL REGISTRATION


International Clinical Trials Registry Platform: DRKS00011121.",2020,We observed a group difference of 1.8° in favour of the intervention group (p = 0.053).,"['strabismus surgery', 'Esotropic patients and patients with hyperopia >\u2009+\u20092\xa0D', ""patients scheduled for purely horizontal strabismus surgery and determined each patient's surgical dose (total amount of recession/plication) either with (study group) or without (control) consideration of the two factors"", 'One hundred one patients were included, 51 of which in the intervention group and 50 in the control group']","['spectacle lenses', 'spectacle lenses and eye ball length']",['median deviation'],"[{'cui': 'C0197981', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020490', 'cui_str': 'Hypermetropia'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0181607', 'cui_str': 'Spectacle lens'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]",101.0,0.238815,We observed a group difference of 1.8° in favour of the intervention group (p = 0.053).,"[{'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Beisse', 'Affiliation': 'Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany. flemming.beisse@med.uni-heidelberg.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Uhlmann', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Beisse', 'Affiliation': 'Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04690-z']
39,32347805,Usability of Food Size Aids in Mobile Dietary Reporting Apps for Young Adults: Randomized Controlled Trial.,"BACKGROUND


Young adults are more likely to use self-managed dietary reporting apps. However, there is scant research examining the user experience of different measurement approaches for mobile dietary reporting apps when dealing with a wide variety of food shapes and container sizes.
OBJECTIVE


Field user experience testing was conducted under actual meal conditions to assess the accuracy, efficiency, and subjective reaction of three food portion measurement methods embedded in a developed mobile app. Key-in-based aid (KBA), commonly used in many current apps, relies on the user's ability to key in volumes or weights. Photo-based aid (PBA) extends traditional assessment methods, allowing users to scroll, observe, and select a reduced-size image from a set of options. Gesture-based aid (GBA) is a new experimental approach in which the user makes finger movements on the screen to roughly describe food portion boundaries accompanied by a background reference.
METHODS


A group of 124 young adults aged 19 to 26 years was recruited for a head-to-head randomized comparison and divided into 3 groups: a KBA (n=42) control group and PBA (n=41) and GBA (n=41) experimental groups. In total, 3 meals (ie, breakfast, lunch, and dinner) were served in a university cafeteria. Participants were provided with 25 dishes and beverages for selection, with a variety of food shapes and containers that reflect everyday life conditions. The accuracy of and time spent on realistic interaction during food portion estimation and the subjective reaction of each aid were recorded and analyzed.
RESULTS


Participants in the KBA group provided the highest accuracy in terms of hash brown weight (P=.004) and outperformed PBA or GBA for many soft drinks in cups. PBA had the best results for a cylindrical hot dog (P<.001), irregularly shaped pork chop (P<.001), and green tea beverage (660 mL; P<.001). GBA outperformed PBA for most drinks, and GBA outperformed KBA for some vegetables. The GBA group spent significantly more time assessing food items than the KBA and PBA groups. For each aid, the overall subjective reaction based on the score of the System Usability Scale was not significantly different.
CONCLUSIONS


Experimental results show that each aid had some distinguishing advantages. In terms of user acceptance, participants considered all 3 aids to be usable. Furthermore, users' subjective opinions regarding measurement accuracy contradicted the empirical findings. Future work will consider the use of each aid based on food or container shape and integrate the various advantages of the 3 different aids for better results. Our findings on the use of portion size aids are based on realistic and diverse food items, providing a useful reference for future app improvement of an effective, evidence-based, and acceptable feature.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Registry ISRCTN36710750; http://www.controlled-trials.com/ISRCTN36710750.",2020,"RESULTS


Participants in the KBA group provided the highest accuracy in terms of hash brown weight (P=.004) and outperformed PBA or GBA for many soft drinks in cups.","['A group of 124 young adults aged 19 to 26 years was recruited for a head-to-head randomized comparison and divided into 3 groups: a', 'Young Adults', 'Young adults']","['Key-in-based aid (KBA', 'Photo-based aid (PBA', 'Food Size Aids', 'Gesture-based aid (GBA', 'control group and PBA', 'GBA', 'KBA']","['System Usability Scale', 'accuracy, efficiency, and subjective reaction', 'time assessing food items']","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",124.0,0.0774607,"RESULTS


Participants in the KBA group provided the highest accuracy in terms of hash brown weight (P=.004) and outperformed PBA or GBA for many soft drinks in cups.","[{'ForeName': 'Ying-Chieh', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': 'Department of Industrial Design, College of Management, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Sheng-Tang', 'Initials': 'ST', 'LastName': 'Wu', 'Affiliation': 'Division of Urology, Department of Surgery, Tri-Service General Hospital and National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Shan-Ju', 'Initials': 'SJ', 'LastName': 'Lin', 'Affiliation': 'Department of Industrial Design, College of Management, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Cyber Security Technology Institute, Institute for Information Industry, Taipei, Taiwan.'}, {'ForeName': 'Yu-Sheng', 'Initials': 'YS', 'LastName': 'Lin', 'Affiliation': 'Health Promotion Center, Department of Internal Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Hsin-Yun', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Department of Nutrition Therapy, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}]",JMIR mHealth and uHealth,['10.2196/14543']
40,32343631,Improving well-being after traumatic brain injury through volunteering: a randomized controlled trial.,"OBJECTIVE


To evaluate the efficacy of a novel intervention facilitating volunteer activity to improve well-being in individuals with traumatic brain injury (TBI).
DESIGN


Randomized two-arm controlled trial, with a wait-list control condition (ClinicalTrials.gov NCT#01728350).
SETTING


Community-based setting.
PARTICIPANTS


Seventy-four community-dwelling individuals at least 1-year post TBI, who had completed inpatient or outpatient TBI rehabilitation.
INTERVENTIONS


A novel intervention, HOPE - Helping Others through Purpose and Engagement, involving orientation/training and a 3-month volunteer placement for the participant, along with training for community agencies regarding TBI.
MAIN OUTCOME MEASURE(S


): Satisfaction With Life Scale (SWLS); Flourishing Scale (FS); Brief Symptom Inventory-18 (BSI-18); Scale of Positive and Negative Experience (SPANE); Purpose in Life subscale (one of six in the Ryff Scale of Psychological Well-Being - 54 item version).
RESULTS


There were significantly greater improvements in life satisfaction (SWLS) and self-perceived success (FS) in the intervention group compared to the control group. There were no significant treatment effects on the additional secondary measures of well-being, although they trended in a positive direction.
CONCLUSIONS


This study supports our primary hypothesis that individuals who take part in a volunteer intervention will demonstrate greater psychological well-being in comparison to a control group.",2020,There were significantly greater improvements in life satisfaction (SWLS) and self-perceived success (FS) in the intervention group compared to the control group.,"['Participants : Seventy-four community-dwelling individuals at least \ufeff1-year post TBI, who had completed inpatient or outpatient TBI rehabilitation', 'individuals with traumatic brain injury (TBI']",['novel intervention facilitating volunteer activity'],"['BSI-18); Scale of Positive and Negative Experience (SPANE); Purpose in Life subscale (one of six in the Ryff Scale of Psychological', 'life satisfaction (SWLS) and self-perceived success (FS', 'Main \ufeffoutcome \ufeffmeasure(s ): Satisfaction With Life Scale (SWLS); Flourishing Scale (FS); Brief Symptom Inventory-18']","[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",74.0,0.0623567,There were significantly greater improvements in life satisfaction (SWLS) and self-perceived success (FS) in the intervention group compared to the control group.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Payne', 'Affiliation': 'Research Department, Craig Hospital , Englewood, CO, USA.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Hawley', 'Affiliation': 'Research Department, Craig Hospital , Englewood, CO, USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Morey', 'Affiliation': 'Research Department, Craig Hospital , Englewood, CO, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Ketchum', 'Affiliation': 'Research Department, Craig Hospital , Englewood, CO, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Philippus', 'Affiliation': 'Research Department, Craig Hospital , Englewood, CO, USA.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Sevigny', 'Affiliation': 'Research Department, Craig Hospital , Englewood, CO, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Harrison-Felix', 'Affiliation': 'Research Department, Craig Hospital , Englewood, CO, USA.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Diener', 'Affiliation': 'Psychology Department, University of Utah , Salt Lake City, UT, USA.'}]",Brain injury,['10.1080/02699052.2020.1752937']
41,32344285,"Non-thyroidal illness syndrome, the hidden player in the septic shock induced myocardial contractile depression.","Septic shock causes high mortality in hospitalized patients, especially in those that develop myocardial dysfunction as an early complication. The myocardial dysfunction of septic shock is characterized by a decrease in ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction). Most patients with septic shock have low serum thyroid hormone levels, a condition known as non-thyroidal illness syndrome. Thyroid hormones sustain myocardial contractility and energy metabolism. Septic shock non-thyroidal illness syndrome causes myocardial hypothyroidism, and hypothyroidism causes myocardial dysfunction that resembles the myocardial depression of septic shock. We hypothesize that the myocardial hypothyroidism that occurs during septic shock has a causal role in the pathogenesis of septic shock-induced myocardial dysfunction. Thyroid hormones regulate the calcium cycle, the phenotype of contractile proteins, adrenergic response, and fatty acid transport and oxidation in the cardiomyocytes. Therefore, the administration of levothyroxine and liothyronine to normalize thyroid hormones level within the myocardium will improve the myocardial function. The hypothesis will be tested in humans with septic shock by performing a prospective, randomized, placebo-controlled study to compare the effect of thyroid hormone administration with placebo on myocardial function. The proposed hypothesis challenges the idea that non-thyroidal illness syndrome is a beneficial response of the thyroid hormone axis to illness and that thyroid hormone replacement is detrimental. The administration of thyroid hormone in order to prevent and reverse myocardial hypothyroidism during septic shock is a new theoretical concept on thyroid hormone metabolism and action at the tissue level during non-thyroidal illness syndrome. If the hypothesis is correct, clinicians should consider cardiac hypothyroidism as a central player in myocardial dysfunction caused by sepsis. Thyroid hormone replacement should be incorporated into the armamentarium of septic shock treatment.",2020,The myocardial dysfunction of septic shock is characterized by a decrease in ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction).,"['hospitalized patients', 'humans with septic shock']","['Thyroid hormone replacement', 'levothyroxine and liothyronine', 'thyroid hormone', 'placebo']","['low serum thyroid hormone levels', 'ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction', 'myocardial function']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}]","[{'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.205492,The myocardial dysfunction of septic shock is characterized by a decrease in ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction).,"[{'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Lado-Abeal', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Internal Medicine, Truman Medical Centers and University of Missouri Kansas City, MO, USA. Electronic address: joaquin.lado@tmcmed.org.'}]",Medical hypotheses,['10.1016/j.mehy.2020.109775']
42,32344324,"Cognitive Restructuring vs. Defusion: Impact on craving, healthy and unhealthy food intake.","Coping with food cravings is crucial for weight management. Individuals tend to use avoidance strategies to resist food cravings and prevent overeating, but such strategies may not result in the benefits sought. This study compared the effects of two cognitive techniques (Restructuring vs. Defusion) for dealing with food cravings in terms of their impact on healthy vs. unhealthy eating behavior (i.e., consumption of chocolate and/or carrots following the intervention). Sixty-five participants (M age  = 19.65 years) received either a 30-minute face-to-face instruction on cognitive restructuring (CR) or cognitive defusion (CD) along with 15 min of practice, or 45 min of obesity education and discussion (control). To examine craving and eating choices following the intervention, participants received bags of chocolate and carrots and were asked to carry these with them at all times over the next week, exchanging the bags every 2 days. Participants in the CD group ate fewer chocolates (M = 11.74) compared to CR (M = 17.06) and Control groups (M = 29.18) during the experimental week. The groups did not differ in number of carrot pieces eaten, though the CD group ate more carrots than chocolates. CD resulted in fewer self-reported cravings compared to CR and CO groups. At a final taste test, both CD and CR groups ate significantly fewer chocolates compared to the CO group. CD appears to be an effective technique in managing food craving and to present some advantages over CR.",2020,"The groups did not differ in number of carrot pieces eaten, though the CD group ate more carrots than chocolates.",['Sixty-five participants (M age \xa0'],"['bags of chocolate and carrots', '30-minute face-to-face instruction on cognitive restructuring (CR) or cognitive defusion (CD) along with 15\xa0min of practice, or 45\xa0min of obesity education and discussion (control', 'CD', 'cognitive techniques (Restructuring vs. Defusion', 'Cognitive Restructuring vs. Defusion']",[],"[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C1141640', 'cui_str': 'Carrot'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],65.0,0.020642,"The groups did not differ in number of carrot pieces eaten, though the CD group ate more carrots than chocolates.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Karekla', 'Affiliation': 'University of Cyprus, Cyprus. Electronic address: mkarekla@ucy.ac.cy.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Georgiou', 'Affiliation': 'University of Cyprus, Cyprus.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Panayiotou', 'Affiliation': 'University of Cyprus, Cyprus.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Sandoz', 'Affiliation': 'University of Louisiana at Lafayette, United States of America.'}, {'ForeName': 'A Solomon', 'Initials': 'AS', 'LastName': 'Kurz', 'Affiliation': 'VISN 17 Center of Excellence for Research on Returning War Veterans, Central Texas Veterans Health Care System, United States of America.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'University of Nicosia, Cyprus.'}]",Eating behaviors,['10.1016/j.eatbeh.2020.101385']
43,32344455,Pregnane X Receptor Activator Rifampin Increases Blood Pressure and Stimulates Plasma Renin Activity.,"We conducted a clinical trial with 22 healthy volunteers to investigate the effects of pregnane X receptor (PXR) agonist rifampin on blood pressure (BP). The study was randomized, crossover, single-blind, and placebo-controlled. Rifampin 600 mg or placebo once daily was administered for a week and the 24-hour ambulatory BP was monitored at the end of each arm on the eighth day. Rifampin elevated the mean systolic and diastolic 24-hour BP (4.7 mmHg, P < 0.0001, and 3.0 mmHg, P < 0.001, respectively) as well as the mean heart rate (3.5 bpm, P = 0.038). The serum renin concentration and the plasma renin activity were increased. Although rifampin increased circulating 4β-hydroxycholesterol (4βHC) as expected, the plasma 4βHC concentration strongly negatively correlated with 24-hour BP, especially systolic, in both rifampin and placebo arms (rifampin systolic BP, r = -0.69, P < 0.001; placebo systolic BP, r = -0.70, P < 0.001). The 4βHC, an agonist for liver X receptor (LXR), induced renin expression modestly in LXR-α expressing Calu-6 cells but only at unphysiologically high 4βHC concentrations. In conclusion, rifampin stimulates renin activity and has a hypertensive effect. This finding should be considered when designing interaction studies involving rifampin or other PXR agonists. Furthermore, PXR may represent a putative therapeutic target for the treatment of hypertension.",2020,"Rifampin elevated the mean systolic and diastolic 24hr BP (4.7 mmHg, P < 0.0001, and 3.0 mmHg, P < 0.001, respectively) as well as the mean heart rate (3.5 bpm, P = 0.038).",['22 healthy volunteers'],"['Pregnane X receptor activator rifampin', 'Rifampin 600 mg or placebo', 'pregnane X receptor (PXR) agonist rifampin', 'rifampin', 'placebo']","['mean systolic and diastolic 24hr BP', 'blood pressure and stimulates plasma renin activity', 'blood pressure (BP', 'plasma 4βHC concentration', 'serum renin concentration and the plasma renin activity', 'circulating 4β-hydroxycholesterol (4βHC', 'mean heart rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0671771', 'cui_str': 'SXR Receptor'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C1104996', 'cui_str': 'Rifampin 600 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0020339', 'cui_str': 'Hydroxycholesterols'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",22.0,0.133873,"Rifampin elevated the mean systolic and diastolic 24hr BP (4.7 mmHg, P < 0.0001, and 3.0 mmHg, P < 0.001, respectively) as well as the mean heart rate (3.5 bpm, P = 0.038).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hassani-Nezhad-Gashti', 'Affiliation': 'Research Unit of Biomedicine, Pharmacology and Toxicology, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Tuire', 'Initials': 'T', 'LastName': 'Salonurmi', 'Affiliation': 'Biocenter Oulu, Oulu, Finland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hautajärvi', 'Affiliation': 'Admescope Ltd., Oulu, Finland.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Rysä', 'Affiliation': 'School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Hakkola', 'Affiliation': 'Research Unit of Biomedicine, Pharmacology and Toxicology, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Hukkanen', 'Affiliation': 'Biocenter Oulu, Oulu, Finland.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1871']
44,32345372,"Protocol for a randomized multicenter study for isolated skin vasculitis (ARAMIS) comparing the efficacy of three drugs: azathioprine, colchicine, and dapsone.","BACKGROUND


Skin-limited forms of vasculitis, while lacking systemic manifestations, can persist or recur indefinitely, cause pain, itch, or ulceration, and be complicated by infection or scarring. High-quality evidence on how to treat these conditions is lacking. The aim of this comparative effectiveness study is to determine the optimal management of patients with chronic skin-limited vasculitis.
METHODS


ARAMIS is a multicenter, sequential, multiple assignment randomized trial with an enrichment design (SMARTER) aimed at comparing the efficacy of three drugs-azathioprine, colchicine, and dapsone-commonly used to treat various forms of isolated skin vasculitis. ARAMIS will enroll patients with isolated cutaneous small or medium vessel vasculitis, including cutaneous small vessel vasculitis, immunoglobulin A (IgA) vasculitis (skin-limited Henoch-Schönlein purpura), and cutaneous polyarteritis nodosa. Patients not responding to the initial assigned therapy will be re-randomized to one of the remaining two study drugs (Stage 2). Those with intolerance or contraindication to a study drug can be randomized directly into Stage 2. Target enrollment is 90 participants, recruited from international centers affiliated with the Vasculitis Clinical Research Consortium. The number of patients enrolled directly into Stage 2 of the study will be capped at 10% of the total recruitment target. The primary study endpoint is the proportion of participants from the pooled study stages with a response to therapy at month 6, according to the study definition.
DISCUSSION


ARAMIS will help identify effective agents for skin-limited forms of vasculitis, an understudied group of diseases. The SMARTER design may serve as an example for future trials in rare diseases.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02939573. Registered on 18 October 2016.",2020,"ARAMIS will enroll patients with isolated cutaneous small or medium vessel vasculitis, including cutaneous small vessel vasculitis, immunoglobulin A (IgA) vasculitis (skin-limited Henoch-Schönlein purpura), and cutaneous polyarteritis nodosa.","['patients with chronic skin-limited vasculitis', 'enroll patients with isolated cutaneous small or medium vessel vasculitis, including cutaneous small vessel vasculitis, immunoglobulin A (IgA) vasculitis (skin-limited Henoch-Schönlein purpura), and cutaneous polyarteritis nodosa', '90 participants, recruited from international centers affiliated with the Vasculitis Clinical Research Consortium', 'isolated skin vasculitis (ARAMIS', 'isolated skin vasculitis']","['azathioprine, colchicine, and dapsone', 'azathioprine, colchicine, and dapsone-commonly']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0042384', 'cui_str': 'Vasculitis'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C4510989', 'cui_str': 'Vasculitis of medium sized vessel'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0151436', 'cui_str': 'Hypersensitivity angiitis'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0034152', 'cui_str': 'Henoch-Schönlein purpura'}, {'cui': 'C0343190', 'cui_str': 'Cutaneous polyarteritis nodosa'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0010980', 'cui_str': 'Dapsone'}]",[],,0.115403,"ARAMIS will enroll patients with isolated cutaneous small or medium vessel vasculitis, including cutaneous small vessel vasculitis, immunoglobulin A (IgA) vasculitis (skin-limited Henoch-Schönlein purpura), and cutaneous polyarteritis nodosa.","[{'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Micheletti', 'Affiliation': 'Departments of Dermatology and Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pagnoux', 'Affiliation': 'Vasculitis Clinic, Department of Rheumatology, Mount Sinai Hospital, University of Toronto, 60 Murray Street, Toronto, ON, M5T3L9, Canada. cpagnoux@mtsinai.on.ca.'}, {'ForeName': 'Roy N', 'Initials': 'RN', 'LastName': 'Tamura', 'Affiliation': 'Health Informatics Institute, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Grayson', 'Affiliation': 'The National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'McAlear', 'Affiliation': 'Divison of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Borchin', 'Affiliation': 'Department of Biostatistics, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': 'Health Informatics Institute, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': 'Divison of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04285-3']
45,32346327,The application of 3D printing patient specific instrumentation model in total knee arthroplasty.,"The application of 3D printing patient specific instrumentation model in total knee arthroplasty was explored to improve the operative accuracy and safety of artificial total knee arthroplasty. In this study, a total of 52 patients who need knee replacement were selected as the study objects, and 52 patients were divided into experimental group and control group. First, the femoral mechanical-anatomical angle (FMAA), lateral femoral angle (LFA), hip-knee-ankle angle (HKA), femorotibial angle (FTA) of research objects in both groups were measured. Then, the blood loss during the operations, drainage volume after operations, total blood loss, hidden blood loss, and hemoglobin decrease of the experiment group and the control group were measured and calculated. Finally, the postoperative outcomes of patients who underwent total knee arthroplasty were evaluated. The results showed that before the operations, in the PSI group, the femoral mechanical-anatomical angle (FMAA) was (6.9 ± 2.4)°, the lateral femoral angle (LFA) was (82.4 ± 1.6)°, the hip-knee-ankle angle (HKA) was (166.4 ± 1.4)°, and the femorotibial angle (FTA) was (179.5 ± 7.3)°. In the CON group, the FMAA was (5.8 ± 2.4)°, the LFA was (81.3 ± 2.1)°, the HKA was (169.5 ± 1.9)°, and the FTA was (185.4 ± 5.4)°. The differences in these data between the two groups were not statistically significant (P > 0.05). After the operations, in the PSI group, the total blood loss, the hidden blood loss, and the hemoglobin (Hb) decrease were respectively (420.2 ± 210.5), (240.5 ± 234.5), and (1.7 ± 0.9); in the CON group, the total blood loss, the hidden blood loss, and the Hb decrease were respectively (782.1 ± 340.4), (450.9 ± 352.6), and (2.9 ± 1.0). These data of both groups were statistically significant (P < 0.05). Therefore, it can be seen that the 3D printing patient specific instrumentation model can effectively simulate the lower limb coronal force line and was highly consistent of the preoperative software simulation plan. In addition, the random interviews of patients who underwent total knee arthroplasty showed that the knees of patients had recovered well. The application of 3D printing patient specific instrumentation model in artificial total knee arthroplasty can effectively improve the operative accuracy and safety, and the clinical therapeutic effects were significant.",2020,"The application of 3D printing patient specific instrumentation model in artificial total knee arthroplasty can effectively improve the operative accuracy and safety, and the clinical therapeutic effects were significant.","['total knee arthroplasty', 'patients who underwent total knee arthroplasty', '52 patients who need knee replacement were selected as the study objects, and 52 patients']",['CON'],"['operative accuracy and safety', 'total blood loss, the hidden blood loss, and the hemoglobin (Hb) decrease', 'femoral mechanical-anatomical angle (FMAA), lateral femoral angle (LFA), hip-knee-ankle angle (HKA), femorotibial angle (FTA) of research objects', 'lateral femoral angle (LFA', 'operative accuracy and safety of artificial total knee arthroplasty', 'total blood loss, hidden blood loss, and hemoglobin decrease', 'femoral mechanical-anatomical angle (FMAA', 'blood loss', 'total blood loss, the hidden blood loss, and the Hb decrease']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]",[],"[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",52.0,0.0180318,"The application of 3D printing patient specific instrumentation model in artificial total knee arthroplasty can effectively improve the operative accuracy and safety, and the clinical therapeutic effects were significant.","[{'ForeName': 'Fengxin', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedics, Tianjin Nankai Hospital, Tianjin 300192, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xue', 'Affiliation': 'Department of Orthopaedics, Tianjin Nankai Hospital, Tianjin 300192, China.'}, {'ForeName': 'Shuquan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, Tianjin Nankai Hospital, Tianjin 300192, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2020.02.017']
46,32352644,Effects of Dapagliflozin on Epicardial Fat Thickness in Patients with Type 2 Diabetes and Obesity.,"OBJECTIVE


Epicardial adipose tissue (EAT) thickness is a marker of visceral fat and an emerging therapeutic target. Dapagliflozin, a selective sodium-glucose cotransporter 2 inhibitor, improves glucose control and induces moderate weight loss in patients with type 2 diabetes mellitus. Dapagliflozin has recently been shown to reduce cardiovascular risk. Nevertheless, whether dapagliflozin could reduce EAT thickness is unknown.
METHODS


This hypothesis was tested in a 24-week, randomized, double-blind, placebo-controlled clinical trial in 100 patients with type 2 diabetes mellitus with BMI ≥ 27 kg/m 2  and a hemoglobin A1c level ≤ 8% on metformin monotherapy. Individuals were randomly assigned to 2 groups to receive additional dapagliflozin up to 10 mg once daily or to remain on metformin up to 1,000 mg twice daily. Ultrasound-measured EAT thickness was measured at baseline, 12 weeks, and 24 weeks.
RESULTS


In the dapagliflozin group, EAT decreased by 20% from baseline to 24 weeks, by 15% after 12 weeks, and by 7% between 12 and 24 weeks, respectively (P < 0.01 for all), whereas in the metformin group, there was a significant but smaller EAT reduction. There was no statistically significant correlation between EAT and body weight changes.
CONCLUSIONS


Dapagliflozin causes a rapid and significant EAT reduction that could be independent of weight loss.",2020,"In the dapagliflozin group, EAT decreased by 20% from baseline to 24 weeks, by 15% after 12 weeks, and by 7% between 12 and 24 weeks, respectively (P < 0.01 for all), whereas in the metformin group, there was a significant but smaller EAT reduction.","['100 patients with type 2 diabetes mellitus with BMI\u2009≥\u200927 kg/m 2  and a hemoglobin A1c level\u2009≤\u20098% on', 'patients with type 2 diabetes mellitus', 'Patients with Type 2 Diabetes and Obesity']","['metformin monotherapy', 'dapagliflozin', 'metformin', 'additional dapagliflozin up to 10 mg once daily or to remain on metformin', 'Dapagliflozin', 'placebo']","['smaller EAT reduction', 'EAT', 'weight loss', 'moderate weight loss', 'EAT and body weight changes', 'Ultrasound-measured EAT thickness', 'EAT thickness', 'Epicardial Fat Thickness']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0442016', 'cui_str': 'Epicardial'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",100.0,0.062762,"In the dapagliflozin group, EAT decreased by 20% from baseline to 24 weeks, by 15% after 12 weeks, and by 7% between 12 and 24 weeks, respectively (P < 0.01 for all), whereas in the metformin group, there was a significant but smaller EAT reduction.","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Iacobellis', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gra-Menendez', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22798']
47,32353544,Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations.,"Opioid use disorder (OUD) in pregnant women has increased significantly in recent years. Maintaining these women on sublingual (SL) buprenorphine (BUP) is an evidence-based practice but BUP-SL is associated with several disadvantages that an extended-release (XR) BUP formulation could eliminate. The National Drug Abuse Treatment Clinical Trials Network (CTN) is conducting an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial, Medication treatment for Opioid-dependent expectant Mothers (MOMs), to compare mother and infant outcomes of pregnant women with OUD treated with BUP-XR, relative to BUP-SL. A second aim is to determine the relative economic value of utilizing BUP-XR. Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization. Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum. Participants will be invited to participate in two sub-studies to evaluate the: 1) mechanisms by which BUP-XR may improve mother and infant outcomes; and 2) effects of prenatal exposure to BUP-XR versus BUP-SL on infant neurodevelopment. This paper describes the key design decisions for the main trial made during protocol development. This Investigational New Drug (IND) trial uniquely uses pragmatic features where feasible in order to maximize external validity, hence increasing the potential to inform clinical practice guidelines and address multiple knowledge gaps for treatment of this patient population.",2020,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","['expectant mothers (MOMs', 'Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30\u202fweeks, recruited from 12 sites', 'pregnant women with OUD treated with BUP-XR, relative to BUP-SL', 'pregnant women']","['sublingual (SL) buprenorphine (BUP', 'buprenorphine formulations', 'prenatal exposure to BUP-XR versus BUP-SL']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],300.0,0.0591114,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Lofwall', 'Affiliation': 'Departments of Behavioral Science and Psychiatry, University of Kentucky College of Medicine, Center on Drug and Alcohol Research, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Hendrée E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina Chapel Hill, 410 North Greensboro St., Carrboro, NC 27510, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Davida M', 'Initials': 'DM', 'LastName': 'Schiff', 'Affiliation': 'Division of General Academic Pediatrics, MassGeneral Hospital for Children, 125 Nashua St Suite 860, Boston, MA 02114, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wexelblatt', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Merhar', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, 425 East 61st Street Suite 301, New York, NY 10065, USA.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': ""Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA; Division of Alcohol, Drug and Addictions and the Division of Women's Mental Health, McLean Hospital, 115 Mill Street, Belmont, MA 02478, USA.""}, {'ForeName': 'Mishka', 'Initials': 'M', 'LastName': 'Terplan', 'Affiliation': 'Friends Research Institute,1040 Park Ave Suite 103, Baltimore, MD 21201, USA.'}, {'ForeName': 'Elisha M', 'Initials': 'EM', 'LastName': 'Wachman', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, 801 Albany Street, Boston, MA 02119, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Medical University of South Carolina, 67 President St., MSC 861, Charleston, SC 29425, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverstein', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston University School of Medicine, 88 East Newton Street, Boston, MA 02118, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rosa', 'Affiliation': 'Center for the Clinical Trials Network, National Institute on Drug Abuse, 6001 Executive Blvd, Bethesda, MD 20892, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106014']
48,32352642,Association between plasma retinol levels and the risk of all-cause mortality in general hypertensive patients: A nested case-control study.,"To evaluate the association between plasma retinol levels with all-cause mortality and investigate the possible effect modifiers in general hypertensive patients with no previous cardiovascular disease (CVD). This case-control study was nested in the China Stroke Primary Prevention Trial (CSPPT), a randomized, double-blind, controlled trial conducted in 32 communities in Anhui and Jiangsu provinces in China. The current study included 617 cases of all-cause mortality and 617 controls matched on age (≤1 year), sex, treatment group, and study site. All-cause mortality was the main outcome in this analysis, which included death due to any reason. The median follow-up duration was 4.5 years. Overall, there was a U-shaped relation of plasma retinol with all-cause mortality. In the threshold effect analysis, the risk of all-cause mortality significantly decreased with the increase in plasma retinol (per 10 μg/dL increments: OR, 0.73; 95% CI: 0.61-0.87) in participants with plasma retinol <58.3 μg/dL and increased with the increase in plasma retinol (per 10 μg/dL increments: OR, 1.08; 95% CI: 1.01-1.16) in those with plasma retinol ≥58.3 μg/L. In participants with plasma retinol <58.3 μg/dL, a stronger inverse association was observed in those with higher time-averaged SBP (≥140 vs <140 mm Hg; P-interaction = .034), or higher vitamin E levels (≥11.5 [quartile 4]; vs <11.5 μg/mL; P-interaction = .013). The present study demonstrated that there was a U-shaped relationship of plasma retinol levels with the risk of all-cause mortality in general hypertensive patients, with a turning point around 58.3 μg/dL.",2020,"(≥140 vs <140 mm Hg; P-interaction = .034), or higher vitamin E levels (≥11.5 [quartile 4]; vs <11.5 μg/mL; P-interaction = .013).","['general hypertensive patients', '617 cases of all-cause mortality and 617 controls matched on age (≤1\xa0year), sex, treatment group, and study site', 'general hypertensive patients, with a turning point around 58.3\xa0μg/dL', '32 communities in Anhui and Jiangsu provinces in China', 'general hypertensive patients with no previous cardiovascular disease (CVD']",[],"['plasma retinol levels', 'vitamin E levels', 'higher time-averaged SBP', 'risk of all-cause mortality', 'plasma retinol']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1142098', 'cui_str': 'Vitamin E measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",617.0,0.192577,"(≥140 vs <140 mm Hg; P-interaction = .034), or higher vitamin E levels (≥11.5 [quartile 4]; vs <11.5 μg/mL; P-interaction = .013).","[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Tengfei', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Huiyuan', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Youbao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Institute of Biomedicine, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Chengzhang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Shenzhen Evergreen Medical Institute, Shenzhen, China.'}, {'ForeName': 'Lishun', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Houqing', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Clinical Laboratory, Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory for Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13866']
49,32353419,"Impact of transcranial direct current stimulation on sustained attention in breast cancer survivors: Evidence for feasibility, tolerability, and initial efficacy.","BACKGROUND


A significant subset of breast cancer survivors experience cognitive difficulties in attention and memory, which persist for years following treatment. Transcranial direct current stimulation (tDCS) has been shown to be effective in improving working memory, attention, processing speed, and other cognitive functions in both healthy and clinical populations. To date, no studies have examined tDCS for rehabilitation of cancer-related cognitive dysfunction.
OBJECTIVE/HYPOTHESIS


We aimed to provide preliminary evidence for feasibility, tolerability, acceptability, and efficacy of tDCS in improving performance on a measure of sustained attention.
METHODS


In a within-subjects design, 16 breast cancer survivors underwent 2 consecutive days of active tDCS over the prefrontal cortex, and 2 days of sham tDCS, counterbalanced for order of stimulation condition, while performing a continuous performance test.
RESULTS


Stimulation was feasible and tolerable, with 89% of participants completing all sessions, and none reporting more than mild to moderate discomfort. Analyses of efficacy showed that during active stimulation, participants had significantly lower standard errors of reaction times overall, indicating better sustained attention ability, as compared to sham stimulation (p < 0.05). Furthermore, the effect of stimulation on standard errors of reaction times differed by inter-stimulus interval (ISI): for 1 and 2 s ISIs, there was no significant difference in performance between sham and active tDCS conditions, but for 4 s ISIs, stimulation improved variability in response times relative to sham (p < 0.05).
CONCLUSIONS


Results suggest that tDCS is feasible, tolerable, and may be an effective intervention to improve sustained attention difficulties in survivors with cancer-related cognitive dysfunction.",2020,"Analyses of efficacy showed that during active stimulation, participants had significantly lower standard errors of reaction times overall, indicating better sustained attention ability, as compared to sham stimulation (p<0.05).","['survivors with cancer-related cognitive dysfunction', 'breast cancer survivors', '16 breast cancer survivors']","['Transcranial direct current stimulation (tDCS', 'tDCS', 'active tDCS', 'transcranial direct current stimulation']","['feasibility, tolerability, acceptability, and efficacy', 'standard errors of reaction times']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",16.0,0.118383,"Analyses of efficacy showed that during active stimulation, participants had significantly lower standard errors of reaction times overall, indicating better sustained attention ability, as compared to sham stimulation (p<0.05).","[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Gaynor', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA. Electronic address: gaynora@mskcc.org.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Pergolizzi', 'Affiliation': 'Universitat Internacional de Catalunya, School of Medicine and Health Sciences, Barcelona, Spain.'}, {'ForeName': 'Yesne', 'Initials': 'Y', 'LastName': 'Alici', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ryan', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Katrazyna', 'Initials': 'K', 'LastName': 'McNeal', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Ahles', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Root', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.04.013']
50,32352912,A Cluster Randomized Controlled Trial of a Lay Health Worker Intervention to Increase Healthy Eating and Physical Activity Among Vietnamese Americans.,"INTRODUCTION


Americans have low levels of knowledge of and adherence to recommendations for healthy eating of fruits and vegetables and for physical activity (HEPA). We conducted a cluster randomized controlled trial of a lay health worker intervention to increase HEPA among Vietnamese Americans.
METHODS


We randomized 64 lay health workers to 2 intervention arms. Each lay health worker recruited 10 participants aged 50 to 74. From 2008 to 2013, using flip charts, lay health workers led 2 educational sessions on HEPA (intervention) or colorectal cancer (comparison). We assessed HEPA knowledge and self-reported behaviors by preintervention and postintervention surveys 6 months apart.
RESULTS


Of the 640 participants, 50.0% were female, 38.4% had lived in the United States for 10 years or fewer, and 71.4% reported limited English proficiency. Knowledge of the recommended intake of fruits and vegetables (≥5 servings daily) increased from 2.6% to 60.5% in the intervention group (n = 311) and from 2.9% to 6.7% in the comparison group (n = 316) (intervention vs comparison change, P < .001). Knowledge of the physical activity recommendation (≥150 minutes weekly) increased from 2.6% to 62.4% among intervention participants and from 1.0% to 2.5% among comparison participants (P < .001). Consumption of 5 or more daily servings of fruits and vegetables increased more in the intervention group (8.4% to 62.1%) than in the comparison group (5.1% to 12.7%) (P < .001). Participants reporting 150 minutes or more of physical activity weekly increased from 28.9% to 54.0% in the intervention group and from 38.0% to 46.8% in the comparison group (intervention vs comparison change, P = .001).
CONCLUSION


A lay health worker intervention increased both healthy eating and physical activity knowledge and self-reported behaviors among older Vietnamese Americans.",2020,A lay health worker intervention increased both healthy eating and physical activity knowledge and self-reported behaviors among older Vietnamese Americans.,"['Vietnamese Americans', 'Each lay health worker recruited 10 participants aged 50 to 74', 'From 2008 to 2013, using flip charts, lay health workers led 2 educational sessions on HEPA (intervention) or colorectal cancer (comparison', 'older Vietnamese Americans', '64 lay health workers to 2 intervention arms']","['health worker intervention', 'Lay Health Worker Intervention', 'lay health worker intervention', 'fruits and vegetables']","['Healthy Eating and Physical Activity', 'healthy eating and physical activity knowledge and self-reported behaviors', 'HEPA knowledge and self-reported behaviors', 'physical activity weekly', 'Consumption of 5 or more daily servings of fruits and vegetables']","[{'cui': 'C4505363', 'cui_str': 'Vietnamese Americans'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]",64.0,0.0231968,A lay health worker intervention increased both healthy eating and physical activity knowledge and self-reported behaviors among older Vietnamese Americans.,"[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Jih', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, 1545 Divisadero St, San Francisco, CA 94115. Email: jane.jih@ucsf.edu.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Stewart', 'Affiliation': 'Department of Public Health Sciences, University of California, Davis.'}, {'ForeName': 'Thien-Nhien', 'Initials': 'TN', 'LastName': 'Luong', 'Affiliation': 'Vietnamese Reach for Health Coalition, Fremont, California.'}, {'ForeName': 'Tung T', 'Initials': 'TT', 'LastName': 'Nguyen', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'McPhee', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco.'}, {'ForeName': 'Bang H', 'Initials': 'BH', 'LastName': 'Nguyen', 'Affiliation': 'Research Department, Cancer Prevention Institute of California, Fremont, California.'}]",Preventing chronic disease,['10.5888/pcd17.190353']
51,32347208,"Yoga improves balance, mobility, and perceived occupational performance in adults with chronic brain injury: A preliminary investigation.","BACKGROUND AND PURPOSE


This was a preliminary investigation to investigate potential benefits of group yoga, as past work has indicated that one-on-one yoga can improve functional deficits in adults with brain injury.
MATERIALS AND METHODS


Participants served as their own controls. Nine participants with chronic brain injury were recruited, and seven (four female) completed the study. Performance measures of balance and mobility and self-reported measures of balance confidence, pain, and occupational performance and satisfaction were used. Data were collected 3 times: baseline (study onset), pre-yoga (after an 8-week no-contact period), and post-yoga (after 8 weeks of yoga). Group yoga was led by a yoga instructor/occupational therapist, and sessions lasted 1 h and occurred twice a week.
RESULTS


No participants withdrew due to adverse effects from yoga. There were no significant changes between baseline and pre-yoga. Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
CONCLUSION


We observed significant improvements in balance, mobility, and self-reported occupational performance in adults with chronic brain injury.",2020,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","['Nine participants with chronic brain injury were recruited, and seven (four female) completed the study', 'adults with brain injury', 'Participants served as their own controls', 'adults with chronic brain injury']",[],"['self-reported occupational performance', 'balance confidence, pain, and occupational performance and satisfaction', 'balance, mobility, and perceived occupational performance', 'functional deficits', 'balance, mobility, and self-reported occupational performance', 'mobility']","[{'cui': 'C0751813', 'cui_str': 'Chronic Brain Injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",9.0,0.0225685,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Stephens', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: jaclyn.stephens@colostate.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van Puymbroeck', 'Affiliation': 'Clemson University, Recreational Therapy Program, USA.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Sample', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: pat.sample@colostate.edu.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Schmid', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: arlene.schmid@colostate.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101172']
52,32347209,"Evaluation of the effectiveness of self-healing training on self-compassion, body image concern, and recovery process in patients with skin cancer.","BACKGROUND AND PURPOSE


The present study aimed to investigate the effect of self-healing training on self-compassion, body image concern, and recovery process in patients with skin cancer.
MATERIALS AND METHODS


The sample consisted of 34 volunteers who were purposefully selected and then randomly divided into experimental (n = 16) and control (n = 18) groups. The research instrument included the Self-Compassion Scale and Body Image Concern Inventory. The self-healing training intervention was then performed on the experimental group for twelve 90-min sessions. Finally, both groups underwent the post-test. Follow-up was performed two and four months after the post-test.
RESULTS


Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05).
CONCLUSION


The self-healing is an appropriate intervention method to increase self-compassion and reduce body image concern and thus accelerate the process of skin cancer recovery.",2020,"RESULTS


Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05).
","['patients with skin cancer', '34 volunteers who were purposefully selected']",['self-healing training'],"['level of body image concern, isolation, and over-identification', 'self-compassion, including self-kindness, self-judgment, and sense of common humanity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0885003', 'cui_str': 'Xiakucao'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0020157', 'cui_str': 'Humanities'}]",34.0,0.00947867,"RESULTS


Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05).
","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran. Electronic address: latifizh@gmail.com.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Soltani', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}, {'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101180']
53,32278029,"Addition of Chinese herbal remedy, Tongguan Capsules, to the standard treatment in patients with myocardial infarction improve the ventricular reperfusion and remodeling: Proteomic analysis of possible signaling pathways.","ETHNOPHARMACOLOGICAL RELEVANCE


Tongguan Capsules (TGC), a patented Chinese herbal remedy containing Salvia miltiorrhiza, Astragalus membranaceus, Borneolum syntheticum and Grasshopper, has been previously tested in the experimental model of animal hearts subjected to ischemia/reperfusion injury and its cardioprotective effect has been described.
AIM OF THE STUDY


This clinical trial was aimed at investigation whether the administration of TGC to patients suffered myocardial infarction (MI), would diminish dilation of the left ventricular (LV) and reduce development of the adverse clinical consequences.
METHODS


Eligible patients were enrolled and randomized 1:1 to TGC (4.5 g/d for 6 months) superimposed on standard treatment for MI, or the control group receiving the standard protocol alone. The outcomes of this trial were valued after 6 months and reported as a mean change from the baseline in LV end-systolic volume index (LVESVI) and as a frequency of MI recurrence, target-vessel revascularization, severity of heart failure or significant arrhythmia that required the additional therapy within 6 months. In addition, arrays with a panel of specific antibodies were used to assess levels of major cytokines and other pathophysiologic markers, that prompted conclusions about the mechanisms of the ultimate clinical outcomes in both patient's subgroups.
RESULTS


Meaningfully, obtained results indicated that MI patients randomly assigned to the TGC treatment, demonstrated a significant reduction of LVESVI (-4.03 ± 0.73 vs. 1.59 ± 0.43 mL/m 2 , P < 0.001) and a lower incidence of the major adverse cardiovascular events (5.45% vs. 11.44%, P = 0.033). Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis.
CONCLUSION


Addition of TGC to the current conventional treatment of MI patients, significantly reduced their adverse LV remodeling and contributed to the more positive clinical outcome.
TRIAL REGISTRATION


ChiCTR-IPR-17011618.",2020,"Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis (adjusted ??","['Eligible patients', 'patients with myocardial infarction', 'patients suffered myocardial infarction (MI']","['TGC', 'Chinese herbal remedy, Tongguan Capsules', 'standard treatment for MI, or the control group receiving the standard protocol alone']","['levels of markers of myocardial apoptosis and fibrosis', 'LVESVI', 'major adverse cardiovascular events', 'LV end-systolic volume index (LVESVI) and as a frequency of MI recurrence, target-vessel revascularization, severity of heart failure or significant arrhythmia', 'adverse LV remodeling', 'serum levels of major inflammatory cytokines']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C2605709', 'cui_str': 'tongguan'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic medicine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",,0.109447,"Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis (adjusted ??","[{'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China; Translational Medicine, Hospital for Sick Children, Toronto, M5G 0A4, Canada.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Ouyang', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.'}, {'ForeName': 'Yuanshen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Ruixiang', 'Initials': 'R', 'LastName': 'Zeng', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Xujie', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Qubo', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Biological Resource Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Minzhou', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. Electronic address: minzhouzhang@aliyun.com.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Hinek', 'Affiliation': 'Translational Medicine, Hospital for Sick Children, Toronto, M5G 0A4, Canada.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.112794']
54,32344650,"The Effect of Vitamin D 3  Supplementation on Hepcidin, Iron, and IL-6 Responses after a 100 km Ultra-Marathon.","Deficiencies in iron and vitamin D are frequently observed in athletes. Therefore, we examined whether different baseline vitamin D 3  levels have any impact on post-exercise serum hepcidin, IL-6 and iron responses in ultra-marathon runners. In this randomized control trial, the subjects (20 male, amateur runners, mean age 40.75 ± 7.15 years) were divided into two groups: experimental (VD) and control (CON). The VD group received vitamin D 3  (10,000 UI/day) and the CON group received a placebo for two weeks before the run. Venous blood samples were collected on three occasions-before the run, after the 100 km ultra-marathon and 12 h after the run-to measure iron metabolism indicators, hepcidin, and IL-6 concentration. After two weeks of supplementation, the intervention group demonstrated a higher level of serum 25(OH)D than the CON group (27.82 ± 5.8 ng/mL vs. 20.41 ± 4.67 ng/mL;  p  < 0.05). There were no differences between the groups before and after the run in the circulating hepcidin and IL-6 levels. The decrease in iron concentration immediately after the 100-km ultra-marathon was smaller in the VD group than CON ( p  < 0.05). These data show that various vitamin D 3  status can affect the post-exercise metabolism of serum iron.",2020,There were no differences between the groups before and after the run in the circulating hepcidin and IL-6 levels.,"['subjects (20 male, amateur runners, mean age 40.75 ± 7.15 years', 'ultra-marathon runners']","['vitamin D', 'CON', 'Vitamin D 3  Supplementation', 'placebo']","['circulating hepcidin and IL-6 levels', 'Venous blood samples', 'higher level of serum 25(OH)D', 'iron metabolism indicators, hepcidin, and IL-6 concentration', 'Hepcidin, Iron, and IL-6 Responses', 'iron concentration']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0673047,There were no differences between the groups before and after the run in the circulating hepcidin and IL-6 levels.,"[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Kasprowicz', 'Affiliation': 'Department of Molecular Biology, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Ratkowski', 'Affiliation': 'Department of Athletics, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Wołyniec', 'Affiliation': 'Department of Occupational, Metabolic and Internal Diseases, Medical University of Gdansk, 81-519 Gdynia, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Kaczmarczyk', 'Affiliation': 'Department of Clinical and Molecular Biochemistry, Pomeranian Medical University, 70-11 Szczecin, Poland.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Witek', 'Affiliation': 'Department of Biochemistry, Institute of Sport, National Research Institute, 01-982 Warsaw, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Żmijewski', 'Affiliation': 'Faculty of Physical Education, Jozef Piłsudski University of Physical Education in Warsaw, 01-813 Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Renke', 'Affiliation': 'Department of Occupational, Metabolic and Internal Diseases, Medical University of Gdansk, 81-519 Gdynia, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Jastrzębski', 'Affiliation': 'Department of Physiology, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rosemann', 'Affiliation': 'Institute of Primary Care, University of Zurich, 8091 Zurich, Switzerland.'}, {'ForeName': 'Pantelis T', 'Initials': 'PT', 'LastName': 'Nikolaidis', 'Affiliation': 'Exercise Physiology Laboratory, 18450 Nikaia, Greece.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Knechtle', 'Affiliation': 'Institute of Primary Care, University of Zurich, 8091 Zurich, Switzerland.'}]",International journal of environmental research and public health,['10.3390/ijerph17082962']
55,32344728,Impact of Active and Passive Hypoxia as Re-Warm-Up Activities on Rugby Players' Performance.,"The aim of this study was to analyse the effect of four types of re-warm-up (R-WU) activity, namely rest in normoxia (RN) at FiO 2  = 20.9%, rest in hypoxia (RH) at FiO 2  = 15%, activity (4 × 5 jumps/15 s) in normoxia (AN) and activity in hypoxia (AH) on physical performance. Ten elite male rugby players completed a 15-min warm-up followed by one of the 15-min randomized R-WU strategies. After R-WU, countermovement jump (CMJ), 20 m sprint and repeat sprint ability (RSA) tests were assessed. Compared to passive strategies (RN and RH), tympanic temperature was higher after active R-WU (AN and AH) ( p  = 0.016). Higher values of CMJ height ( p  = 0.037) and 20 m sprint ( p  = 0.02) were found in AH than in RN. In addition, mean RSA was lower ( p  = 0.008) in AH than in RN and RH. Blood lactate concentration was higher ( p  = 0.007) after RN and AN strategies than after AH. Muscle O 2  saturation ( p  = 0.021) and total Hb ( p  = 0.042) were higher after AH than after the other three conditions and after RN, respectively. Therefore, an active R-WU under hypoxia could be useful to elite rugby players, once it had attenuated the decline in tympanic temperature during a 15-min period after warm-up, improving jump, sprint and RSA performance.",2020,"Muscle O 2  saturation ( p  = 0.021) and total Hb ( p  = 0.042) were higher after AH than after the other three conditions and after RN, respectively.",['Ten elite male rugby players'],"['re-warm-up (R-WU) activity, namely rest in normoxia (RN', 'Active and Passive Hypoxia as Re-Warm-Up Activities']","['mean RSA', 'Muscle O 2  saturation', 'countermovement jump (CMJ), 20 m sprint and repeat sprint ability (RSA) tests', 'CMJ height', 'total Hb', 'normoxia (AN) and activity in hypoxia (AH) on physical performance', 'passive strategies (RN and RH), tympanic temperature', 'Blood lactate concentration']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}]","[{'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1532039', 'cui_str': 'Tympanic temperature'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",10.0,0.034329,"Muscle O 2  saturation ( p  = 0.021) and total Hb ( p  = 0.042) were higher after AH than after the other three conditions and after RN, respectively.","[{'ForeName': 'Domingo Jesús', 'Initials': 'DJ', 'LastName': 'Ramos-Campo', 'Affiliation': 'Faculty of Sports, UCAM, Catholic University San Antonio, 30107 Murcia, Spain.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Malta', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, 7000-645 Évora, Portugal.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Olcina', 'Affiliation': 'Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Timón', 'Affiliation': 'Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Raimundo', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, 7000-645 Évora, Portugal.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Tomas-Carus', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, 7000-645 Évora, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph17082971']
56,32344735,The Usefulness of Serum Biomarkers in the Early Stages of Diabetic Retinopathy: Results of the EUROCONDOR Clinical Trial.,"The main aim of this study was to evaluate the ability of serum biomarkers to predict the worsening of retinal neurodysfunction in subjects with type 2 diabetes. For this purpose, we measured selected molecules (N-epsilon-carboxy methyl lysine (CML), laminin P1 (Lam-P1), and asymmetric dimethylarginine (ADMA)) in the serum of 341 participants of the EUROCONDOR study at baseline, 24, and 48 weeks. Retinal neurodysfunction was assessed by measuring implicit time (IT) using multifocal electroretinography, and structural changes were examined by spectral domain-optical coherence tomography. The values of IT at baseline were directly correlated with baseline serum concentrations of CML ( r  = 0.135,  p  = 0.013). Furthermore, in the placebo group, increase in CML concentration throughout follow-up correlated with the IT ( r  = 0.20;  p  = 0.03). Baseline serum levels of CML also correlated with macular retinal thickness (RT) ( r  = 0.231;  p  < 0.001). Baseline Lam-P1 levels correlated with the increase of the RT at the end of follow-up in the placebo group ( r  = 0.22;  p  = 0.016). We provide evidence that CML may be a biomarker of both retinal neurodysfunction and RT, whereas Lam-P1 was associated with RT only. Therefore, circulating levels of these molecules could provide a complementary tool for monitoring the early changes of diabetic retinopathy (DR).",2020,Baseline Lam-P1 levels correlated with the increase of the RT at the end of follow-up in the placebo group ( r  = 0.22;  p  = 0.016).,"['341 participants of the EUROCONDOR study at baseline, 24, and 48 weeks', 'subjects with type 2 diabetes', 'Diabetic Retinopathy']",['placebo'],"['Baseline serum levels of CML', 'macular retinal thickness (RT', 'Baseline Lam-P1 levels', 'implicit time (IT) using multifocal electroretinography, and structural changes', 'selected molecules (N-epsilon-carboxy methyl lysine (CML), laminin P1 (Lam-P1), and asymmetric dimethylarginine (ADMA', 'CML concentration']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1627756', 'cui_str': 'Multifocal electroretinography'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0113456', 'cui_str': ""di(1,N(6)-ethenoadenosine)-5',5'''-P(1),P(4)-tetraphosphate""}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0064633', 'cui_str': 'laminin P1'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",341.0,0.09547,Baseline Lam-P1 levels correlated with the increase of the RT at the end of follow-up in the placebo group ( r  = 0.22;  p  = 0.016).,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hernández', 'Affiliation': ""Diabetes and Metabolism Research Unit and CIBERDEM, Vall d'Hebron Research Institute, 08035 Barcelona, Spain.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Porta', 'Affiliation': 'Department of Medical Sciences, University of Turin, 10124 Turin, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bandello', 'Affiliation': 'Department of Ophthalmology, Scientific Institute San Raffaele, University Vita-Salute, 20132 Milano, Italy.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Grauslund', 'Affiliation': 'Research Unit of Ophthalmology, Department of Clinical Research, University of Southern Denmark, 5230 Odense, Denmark.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Harding', 'Affiliation': ""Department of Eye & Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, and St. Pauls' Eye Unit. Liverpool University Hospitals, members of Liverpool Health Partners, Liverpool L69 7ZX, UK.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Aldington', 'Affiliation': 'Gloucestershire Hospitals National Health Service Foundation Trust, Cheltenham GL53 7AG, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Egan', 'Affiliation': 'Moorfields Eye Hospital National Health Service Foundation Trust, Institute of Ophthalmology/University College London, London EC1V 2PD, UK.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Frydkjaer-Olsen', 'Affiliation': 'Research Unit of Ophthalmology, Department of Clinical Research, University of Southern Denmark, 5230 Odense, Denmark.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'García-Arumí', 'Affiliation': ""Department of Ophthalmology, Vall d'Hebron University Hospital, 08035 Barcelona, Spain.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Gibson', 'Affiliation': 'Department of Vision Sciences, Aston University, Birmingham B4 7ET, UK.'}, {'ForeName': 'Gabriele E', 'Initials': 'GE', 'LastName': 'Lang', 'Affiliation': 'Department of Ophthalmology, University of Ulm, 89081 Ulm, Germany.'}, {'ForeName': 'Rosangela', 'Initials': 'R', 'LastName': 'Lattanzio', 'Affiliation': 'Department of Ophthalmology, Scientific Institute San Raffaele, University Vita-Salute, 20132 Milano, Italy.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Massin', 'Affiliation': 'Department of Ophthalmology, Lariboisière Hospital, 75004 Paris, France.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Midena', 'Affiliation': 'Department of Ophthalmology, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Berta', 'Initials': 'B', 'LastName': 'Ponsati', 'Affiliation': 'BCN Peptides, 08777 Barcelona, Spain.'}, {'ForeName': 'Luísa', 'Initials': 'L', 'LastName': 'Ribeiro', 'Affiliation': 'Association for Innovation and Biomedical Research on Light and Image (AIBILI), 3000-548 Coimbra, Portugal.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Scanlon', 'Affiliation': 'Gloucestershire Hospitals National Health Service Foundation Trust, Cheltenham GL53 7AG, UK.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Cunha-Vaz', 'Affiliation': 'Association for Innovation and Biomedical Research on Light and Image (AIBILI), 3000-548 Coimbra, Portugal.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Simó', 'Affiliation': ""Diabetes and Metabolism Research Unit and CIBERDEM, Vall d'Hebron Research Institute, 08035 Barcelona, Spain.""}]",Journal of clinical medicine,['10.3390/jcm9041233']
57,32348699,How short is too short? A randomised controlled trial evaluating short-term existential behavioural therapy for informal caregivers of palliative patients.,"BACKGROUND


Informal caregivers of palliative patients show higher levels of depression and distress compared with the general population. Fegg's (2013) existential behavioural therapy was shortened to two individual 1-h sessions (short-term existential behavioural therapy).
AIM


Testing the effectiveness of sEBT on psychological symptoms of informal caregivers in comparison with active control.
DESIGN


Randomised controlled trial.
SETTING/PARTICIPANTS


Informal caregivers of palliative in-patients.
METHODS


The primary outcome was depression; secondary outcomes were anxiety, subjective distress and minor mental disorders, positive and negative affect, satisfaction with life, quality of life and direct health care costs. General linear mixed models allow several measurements per participant and change over time. Reasons for declining the intervention were investigated by Rosenstock's Health Belief Model.
RESULTS


Overall inclusion rate was 41.0%. Data of 157 caregivers were available (63.1% females; mean age: 54.6 years, standard deviation (SD): 14.1); 127 participants were included in the main analysis. Participation in sEBT or active control was not significantly associated with post-treatment depression. Outcomes showed prevailingly significant association with time of investigation. Self-efficacy, scepticism of benefit of the intervention, belief of better coping alone and support by family and friends were significant factors in declining participation in the randomised controlled trial.
CONCLUSION


Inclusion rate was tripled compared with a previously evaluated longer EBT group intervention. By shortening the intervention, inclusion rate was traded for effectiveness and the intervention could not impact caregivers' psychological state. Early integration of sEBT and combination of individual and group setting and further study of the optimal length for caregiver interventions are suggested.",2020,Participation in sEBT or active control was not significantly associated with post-treatment depression.,"['Informal caregivers of palliative in-patients', 'informal caregivers in comparison with active control', '157 caregivers were available (63.1% females; mean age: 54.6\u2009years, standard deviation (SD): 14.1); 127 participants were included in the main analysis', 'informal caregivers of palliative patients', 'Informal caregivers of palliative patients']","['sEBT', 'short-term existential behavioural therapy']","['anxiety, subjective distress and minor mental disorders, positive and negative affect, satisfaction with life, quality of life and direct health care costs', 'depression and distress']","[{'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",127.0,0.213714,Participation in sEBT or active control was not significantly associated with post-treatment depression.,"[{'ForeName': 'Martina B', 'Initials': 'MB', 'LastName': 'Kühnel', 'Affiliation': 'Department of Palliative Medicine, Munich University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Marchioro', 'Affiliation': 'Statistical Consulting Unit (StaBLab), Department of Statistics, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Deffner', 'Affiliation': 'Statistical Consulting Unit (StaBLab), Department of Statistics, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bausewein', 'Affiliation': 'Department of Palliative Medicine, Munich University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Hildegard', 'Initials': 'H', 'LastName': 'Seidl', 'Affiliation': 'Institute of Health Economics and Health Care Management, Helmholtz Center Munich, Neuherberg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Siebert', 'Affiliation': 'Department of Palliative Medicine, Munich University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fegg', 'Affiliation': 'Department of Palliative Medicine, Munich University Hospital, Ludwig-Maximilians-University, Munich, Germany.'}]",Palliative medicine,['10.1177/0269216320911595']
58,32349513,"Immediate Effects of Self-Thai Foot Massage on Skin Blood Flow, Skin Temperature, and Range of Motion of the Foot and Ankle in Type 2 Diabetic Patients.","Objectives:  The purpose of this study was to investigate the immediate effects of self-Thai foot massages (STFMs) on the foot skin blood flow, the foot skin temperature, and range of motion (ROM) of the foot and ankle in type 2 diabetic patients with peripheral neuropathy.  Design:  A randomized crossover study.  Subjects:  Twenty five diabetic patients with peripheral neuropathy were recruited.  Interventions:  Participants were randomly assigned to either STFM or Thai foot massage (TFM) performed by a massage therapist; then, they were switched to the other group after a 1-week washout period. In both groups, the foot massage was performed in a seated position on the dominant lower leg and foot for 25 min.  Outcome measures:  Before and immediately after treatment, foot skin blood flow, foot skin temperature, and ROM of the foot and ankle were evaluated. Heart rate was measured throughout the treatment.  Results:  After a single treatment of the massage, foot skin blood flow and ROM of the foot and ankle significantly improved in both groups ( p  < 0.05). Foot skin temperature did not change in STFM, whereas it significantly increased in TFM. Heart rate significantly increased in STFM, whereas it tended to decrease in TFM.  Conclusions:  Both STFM and TFM by a massage therapist could improve foot skin blood flow and ROM of the foot and ankle in diabetic patients with peripheral neuropathy. An STFM could be a promising alternative treatment that patients can perform at home.",2020,"After a single treatment of the massage, foot skin blood flow and ROM of the foot and ankle significantly improved in both groups ( p  < 0.05).","['Subjects:  Twenty five diabetic patients with peripheral neuropathy were recruited', 'Type 2 Diabetic Patients', 'type 2 diabetic patients with peripheral neuropathy', 'diabetic patients with peripheral neuropathy']","['self-Thai foot massages (STFMs', 'STFM', 'STFM or Thai foot massage (TFM) performed by a massage therapist', 'Self-Thai Foot Massage', 'STFM and TFM']","['Skin Blood Flow, Skin Temperature, and Range of Motion of the Foot and Ankle', 'TFM', 'Heart rate', 'Outcome measures:  Before and immediately after treatment, foot skin blood flow, foot skin temperature, and ROM of the foot and ankle', 'foot skin blood flow, the foot skin temperature, and range of motion (ROM', 'foot skin blood flow and ROM', 'Foot skin temperature', 'foot skin blood flow and ROM of the foot and ankle']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}]",25.0,0.0167828,"After a single treatment of the massage, foot skin blood flow and ROM of the foot and ankle significantly improved in both groups ( p  < 0.05).","[{'ForeName': 'Uraiwan', 'Initials': 'U', 'LastName': 'Chatchawan', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kawita', 'Initials': 'K', 'LastName': 'Jarasrungsichol', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Junichiro', 'Initials': 'J', 'LastName': 'Yamauchi', 'Affiliation': 'Research Center in Back, Neck, Other Joint Pain and Human Performance, Khon Kaen University, Khon Kaen, Thailand.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0328']
59,32353816,Effects of a Mindfulness-based Intervention on diurnal cortisol pattern in disadvantaged families: A randomized controlled trial.,"OBJECTIVE


The present study examined the psychophysiological effects of Family-based Mindfulness Intervention (FBMI) on children and parents from disadvantaged families.
METHODS


This randomized controlled trial recruited parents and their children from 51 disadvantaged families in Hong Kong and randomized them into FBMI (n = 26) and waitlist control (n = 25) groups. The parent intervention included 6 sessions and the child intervention included 8 sessions with 2 half-hour joint programs. Both interventions lasted 9 hours in total each. All participants completed four salivary cortisol measures after wakeup, before lunchtime, late-afternoon, and before sleep at baseline and end of the intervention. The diurnal cortisol pattern was summarized by the morning cortisol, evening cortisol, mean cortisol, and diurnal cortisol slope.
RESULTS


Compared to the control group, children in the FBMI group showed significant increases in morning cortisol (d = 0.50, p =  0.03) and significant decreases in diurnal cortisol slopes (d = 0.50, p =  0.04) at the end of intervention. Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p =  0.04) compared to the control group at the end of intervention. No significant treatment effects were found on the mean cortisol.
DISCUSSION


The present findings suggest that FBMI could improve the diurnal cortisol slope and cortisol levels of the children and parents from disadvantaged families, respectively. Future studies should elucidate its potential benefits on neuroendocrine functioning.",2020,"Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p =  0.04) compared to the control group at the end of intervention.","['children and parents from disadvantaged families', 'parents and their children from 51 disadvantaged families in Hong Kong and randomized them into FBMI (n\u202f=\u202f26) and waitlist control (n\u202f=\u202f25) groups', 'disadvantaged families']","['Mindfulness-based Intervention', 'FBMI', 'Family-based Mindfulness Intervention (FBMI', 'child intervention included 8 sessions with 2 half-hour joint programs']","['morning cortisol, evening cortisol, mean cortisol, and diurnal cortisol slope', 'diurnal cortisol slopes', 'morning cortisol', 'evening cortisol', 'diurnal cortisol slope and cortisol levels', 'salivary cortisol measures', 'mean cortisol', 'diurnal cortisol pattern']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",51.0,0.0257721,"Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p =  0.04) compared to the control group at the end of intervention.","[{'ForeName': 'Rainbow T H', 'Initials': 'RTH', 'LastName': 'Ho', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Hong Kong; Department of Social Work & Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Herman H M', 'Initials': 'HHM', 'LastName': 'Lo', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong. Electronic address: herman.lo@polyu.edu.hk.'}, {'ForeName': 'Ted C T', 'Initials': 'TCT', 'LastName': 'Fong', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Hong Kong; Department of Social Work & Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Choi', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104696']
60,32353822,Effects of sugammadex on postoperative respiratory management in children with congenital heart disease: a randomized controlled study.,"BACKGROUND


Early extubation can reduce pulmonary complications in children undergoing cardiac surgery. The aim of this study is to evaluate the effects of sugammadex for postoperative respiratory management in children with congenital heart disease.
METHODS


Sixty children with congenital heart disease undergoing elective cardiac surgery were divided into group S and group C (30 children in each group). When post tetanic twitches count (PTC) = 1-2 and train-of-four (TOF) = 0, the children in group S received sugammadex4 mg/kg for reversal of neuromuscular block at the end of surgery, and the children in group C received the same volume of normal saline. The recovery time to TOF of 0.9, the mechanical ventilation and extubation times were recorded. On the other side, the hemodynamic parameters before and 5 min after administration, and side effects were also recorded. The levels of C-reactive protein (CRP) and procalcitonin (PCT) before and 24 h after surgery were measured.
RESULTS


The recovery time to TOF of 0.9 and extubation time were significantly shorter in the group S than in the group C (4.2 ± 1.4 vs 108.2 ± 26.7 min, 66.3 ± 6.5 vs 171.6 ± 23.1 min, respectively, P <  0.01). The CRP and PCT levels were found to be increased in both groups at postoperative 24 h than before surgery. Further, the levels of PCT and CRP at postoperative 24 h were lower in group S when compared to group C (median, 7 vs 17.5 mg/ml, 1.76 vs 5.22 ng/ml, respectively, P <  0.05). There were no statistical differences observed between the two groups (P> 0.05) with respect to side effects.
CONCLUSION


Sugammadex is rapid and effective in reversing rocuronium-induced neuromuscular block, and significantly reduces the extubation time and the release of postoperative CRP and PCT in children with congenital heart diseases.",2020,"The levels of C-reactive protein (CRP) and procalcitonin (PCT) before and 24 h after surgery were measured.
","['children undergoing cardiac surgery', 'children with congenital heart diseases', 'Sixty children with congenital heart disease undergoing elective cardiac surgery', 'children with congenital heart disease']","['sugammadex', 'Sugammadex']","['levels of PCT and CRP', 'postoperative respiratory management', 'levels of C-reactive protein (CRP) and procalcitonin (PCT', 'CRP and PCT levels', 'pulmonary complications', 'extubation time', 'recovery time to TOF of 0.9 and extubation time', 'recovery time to TOF of 0.9, the mechanical ventilation and extubation times']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",60.0,0.104172,"The levels of C-reactive protein (CRP) and procalcitonin (PCT) before and 24 h after surgery were measured.
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xiaobing', 'Affiliation': ""Department of Cardiothoracic Surgery, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China.""}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""Department of Anesthesiology, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China.""}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Wangping', 'Affiliation': ""Department of Anesthesiology, Women and Children's Hospital of Jiaxing University, Jiaxing 314000, China. Electronic address: zhang650679@163.com.""}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Rufang', 'Affiliation': ""Department of Cardiothoracic Surgery, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China. Electronic address: zhangrf398@163.com.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': ""Department of Cardiothoracic Surgery, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Rong', 'Affiliation': ""Department of Anesthesiology, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China.""}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110180']
61,32353830,Implications of maraviroc and/or rapamycin in a mouse model of fragility.,"BACKGROUND


As age increases, the risk of developing fragility also increases. Improving the knowledge of frailty could contribute to maintaining the functional ability of elderly people. Interleukin (IL)-10 homozygous knockout mice (IL-10 tm/tm  [IL10KO]) constitute an excellent tool for the study of frailty. Because patients with frailty demonstrate an overexpression of CCR5, rapamycin (RAPA) and/or maraviroc (MVC), two molecules able to decrease CCR5 expression, were evaluated.
RESULTS


Muscle myostatin was reduced in all the therapeutic groups but the MVC group (p <0.001 for RAPA and MVC-RAPA) and in serum samples (p <0.01 for all the groups). Serum CK levels were also significantly lower in MVC and RAPA groups (p <0.01 in both cases). Lower AST levels were observed in all the therapeutic groups (p <0.05 for all of them). The apoptotic effector caspase-3 was significantly lower in MVC and RAPA groups (p<0.05 in both cases). Combined treatment with MVC-RAPA showed a synergistic increase in p-AKT, p-mTOR and SIRT1 levels.
CONCLUSIONS


MVC and RAPA show a protective role in some factors involved in frailty. More studies are needed to prove their clinical applications.
MATERIAL AND METHODS


Eighty male homozygous IL10KOs were randomly assigned to one of 4 groups (n= 20): i) IL10KO group (IL10KO); ii) IL10KO receiving MVC in drinking water (MVC group), iii) IL10KO receiving RAPA in drinking water (RAPA group), and finally, iv) MVC-RAPA group that received MVC and RAPA in drinking water. Blood and muscle samples were analysed. Survival analysis, frailty index calculation, and functional assessment were also performed.",2020,"Combined treatment with MVC-RAPA showed a synergistic increase in p-AKT, p-mTOR and SIRT1 levels.
",['Eighty male homozygous IL10KOs'],"['Interleukin (IL)-10 homozygous knockout mice (IL-10 tm/tm  [IL10KO', 'maraviroc and/or rapamycin', 'MVC-RAPA', 'IL10KO group (IL10KO); ii) IL10KO receiving MVC in drinking water (MVC group), iii) IL10KO receiving RAPA in drinking water (RAPA group), and finally, iv) MVC-RAPA group that received MVC and RAPA in drinking water']","['Muscle myostatin', 'apoptotic effector caspase-3', 'Serum CK levels', 'Survival analysis, frailty index calculation, and functional assessment', 'Lower AST levels', 'synergistic increase in p-AKT, p-mTOR and SIRT1 levels', 'overexpression of CCR5, rapamycin (RAPA) and/or maraviroc (MVC']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}]","[{'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0206745', 'cui_str': 'Mouse, Knockout'}, {'cui': 'C1667052', 'cui_str': 'maraviroc'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C1720985', 'cui_str': 'Effector Caspases'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0164786', 'cui_str': 'c-akt Proto-Oncogene Protein'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C3711103', 'cui_str': 'CCR5 protein, human'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1667052', 'cui_str': 'maraviroc'}]",80.0,0.0189046,"Combined treatment with MVC-RAPA showed a synergistic increase in p-AKT, p-mTOR and SIRT1 levels.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pérez-Martínez', 'Affiliation': 'Centro de Investigación Biomédica de La Rioja (CIBIR), Logroño, España.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Romero', 'Affiliation': 'Centro de Investigación Biomédica de La Rioja (CIBIR), Logroño, España.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Muñoz-Galván', 'Affiliation': 'Instituto de Biomedicina de Sevilla, IBIS, Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Consejo Superior de Investigaciones Científicas, Sevilla, España.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Verdugo-Sivianes', 'Affiliation': 'Instituto de Biomedicina de Sevilla, IBIS, Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Consejo Superior de Investigaciones Científicas, Sevilla, España.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Rubio-Mediavilla', 'Affiliation': 'Servicio de Anatomía Patológica, Hospital San Pedro, Logroño, España.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Oteo', 'Affiliation': 'Centro de Investigación Biomédica de La Rioja (CIBIR), Logroño, España.'}, {'ForeName': 'Amancio', 'Initials': 'A', 'LastName': 'Carnero', 'Affiliation': 'Instituto de Biomedicina de Sevilla, IBIS, Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Consejo Superior de Investigaciones Científicas, Sevilla, España.'}, {'ForeName': 'José-Ramón', 'Initials': 'JR', 'LastName': 'Blanco', 'Affiliation': 'Centro de Investigación Biomédica de La Rioja (CIBIR), Logroño, España.'}]",Aging,['10.18632/aging.103167']
62,32345707,A novel decision aid to help plan for serious illness: a multisite randomized trial.,"BACKGROUND


Recent studies have shown substantial deficiencies in the quality or quantity (or both) of communication and decision-making during serious illness. We evaluated the efficacy of a novel decision support intervention, the Plan Well Guide, in increasing completion of a standard medical order form for advance medical care planning and improving decisional outcomes in nonacademic primary care settings.
METHODS


We conducted a randomized trial in 3 primary care practices in Lethbridge, Alberta in 2017-2018. We recruited ""patients at high risk"" referred by the primary care doctor who required establishment or review of their Goals of Care Designation (GCD). Enrolled patients were randomly allocated to receive the Plan Well Guide, delivered by a trained facilitator, or usual care. Eight to 12 weeks after the intervention, a research assistant blinded to intervention assignment contacted the patients in both groups by telephone to do a final outcome assessment. The primary outcome was completion of GCD forms; secondary outcomes included decisional conflict scores and ratings of satisfaction.
RESULTS


A total of 123 patients (59 women [48.0%]; mean age 73.9 yr) were enrolled, 66 in the intervention arm and 57 in the usualcare arm; 119 patients completed the trial. After the intervention, GCD completion rates in the intervention and usual-care groups were 95.3% and 90.9%, respectively (risk difference [RD] 4%, 95% confidence interval [CI] -14% to 22%), and the rate of concordance between medical orders and expressed preferences on follow-up was 78% and 66%, respectively (RD 12%, 95% CI -7% to 30%). Significantly fewer patients in the intervention group than in the usual-care group had written medical orders for intensive care unit care and cardiopulmonary resuscitation (22 [34%] v. 33 [60%], RD -26%, 95% CI -42% to -8%). Patients in the intervention group had lower decisional conflict scores than those in the usual-care group (mean 30.9 v. 43.1, adjusted mean difference -12.0, 95% CI -23.2 to -0.8). Physicians considered patients in the intervention group to have lower decisional conflict than those in the usual-care group, although not significantly so (mean score 10.4 v. 14.9, adjusted mean difference -4.7, 95% CI -9.9 to 0.4) and spent less time with the former (mean 9.7 v. 13.2 min, adjusted mean difference -3.5, 95% CI -5.5 to -1.5 min).
INTERPRETATION


The decision-support intervention did not increase GCD completion rates but did seem to improve some aspects of decisional quality while reducing the physician's time to accomplish GCD decisions.  Trial registration:  ClinicalTrials.gov, no. NCT01297946.",2020,"Significantly fewer patients in the intervention group than in the usual-care group had written medical orders for intensive care unit care and cardiopulmonary resuscitation (22 [34%] v. 33 [60%],","['3 primary care practices in Lethbridge, Alberta in 2017-2018', 'patients at high risk"" referred by the primary care doctor who required establishment or review of their Goals of Care Designation (GCD', '123 patients (59 women [48.0%]; mean age 73.9 yr) were enrolled, 66 in the intervention arm and 57 in the usualcare arm; 119 patients completed the trial']","['novel decision support intervention', 'Plan Well Guide, delivered by a trained facilitator, or usual care']","['rate of concordance between medical orders and expressed preferences', 'lower decisional conflict', 'decisional quality', 'lower decisional conflict scores', 'written medical orders for intensive care unit care and cardiopulmonary resuscitation', 'GCD completion rates', 'decisional conflict scores and ratings of satisfaction']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",3.0,0.122672,"Significantly fewer patients in the intervention group than in the usual-care group had written medical orders for intensive care unit care and cardiopulmonary resuscitation (22 [34%] v. 33 [60%],","[{'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ""Department of Critical Care Medicine (D. Heyland), Kingston General Hospital; Department of Public Health Sciences (D. Heyland), Queen's University; Clinical Evaluation Research Unit (D. Heyland, R. Heyland), Kingston General Hospital, Kingston, Ont.; Bigelow Fowler Clinic (Bailey), Lethbridge, Alta.; Department of Family Medicine (Howard), McMaster University, Hamilton, Ont. dkh2@queensu.ca.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Heyland', 'Affiliation': ""Department of Critical Care Medicine (D. Heyland), Kingston General Hospital; Department of Public Health Sciences (D. Heyland), Queen's University; Clinical Evaluation Research Unit (D. Heyland, R. Heyland), Kingston General Hospital, Kingston, Ont.; Bigelow Fowler Clinic (Bailey), Lethbridge, Alta.; Department of Family Medicine (Howard), McMaster University, Hamilton, Ont.""}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Bailey', 'Affiliation': ""Department of Critical Care Medicine (D. Heyland), Kingston General Hospital; Department of Public Health Sciences (D. Heyland), Queen's University; Clinical Evaluation Research Unit (D. Heyland, R. Heyland), Kingston General Hospital, Kingston, Ont.; Bigelow Fowler Clinic (Bailey), Lethbridge, Alta.; Department of Family Medicine (Howard), McMaster University, Hamilton, Ont.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Howard', 'Affiliation': ""Department of Critical Care Medicine (D. Heyland), Kingston General Hospital; Department of Public Health Sciences (D. Heyland), Queen's University; Clinical Evaluation Research Unit (D. Heyland, R. Heyland), Kingston General Hospital, Kingston, Ont.; Bigelow Fowler Clinic (Bailey), Lethbridge, Alta.; Department of Family Medicine (Howard), McMaster University, Hamilton, Ont.""}]",CMAJ open,['10.9778/cmajo.20190179']
63,32348282,Correction: A Smartphone App to Improve Medication Adherence in Patients With Type 2 Diabetes in Asia: Feasibility Randomized Controlled Trial.,[This corrects the article DOI: 10.2196/14914.].,2020,[This corrects the article DOI: 10.2196/14914.].,['Patients With Type 2 Diabetes in Asia'],['Smartphone App'],['Medication Adherence'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0003980', 'cui_str': 'Asia'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",,0.0584139,[This corrects the article DOI: 10.2196/14914.].,"[{'ForeName': 'Zhilian', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Eberta', 'Initials': 'E', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Lum', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sloot', 'Affiliation': 'Complexity Institute, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Bernhard Otto', 'Initials': 'BO', 'LastName': 'Boehm', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}]",JMIR mHealth and uHealth,['10.2196/18411']
64,32348435,"Panacea, placebo or poison? Genetically guided treatment for depression.",,2020,,[],"['Panacea, placebo']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.116168,,"[{'ForeName': 'Erika L', 'Initials': 'EL', 'LastName': 'Nurmi', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California at Los Angeles, Los Angeles, CA, USA.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0772']
65,32348797,"Anticipation of 24 h severe energy restriction increases energy intake and reduces physical activity energy expenditure in the prior 24 h, in healthy males.","Intermittent fasting involves alternating between severely restricted and unrestricted energy intake. Physical activity energy expenditure (PAEE) is reduced during, and energy intake is elevated after, a period of energy restriction, but whether these are altered in anticipation of energy restriction is unknown. The aim of this study was to assess energy intake and PAEE in the 24 h before severe energy restriction. In randomised, counterbalanced order, 14 healthy males completed two 48 h trials over 3 days. On day 1, participants were informed which diet they would receive on day 2; either an energy balanced diet providing 100% (2755 (159) kcal; EB) or an energy restricted diet providing 25% (691 (42) kcal; ER), of their estimated energy requirements. Throughout day 1, ad-libitum energy intake was then determined from researcher-provided breakfast (08:30-09:00), lunch (12:30-13:00), afternoon snacks (14:00-18:00) and dinner (19:30-20:00). On day 2, participants consumed their allocated diet as instructed. On day 3, ad-libitum energy intake was assessed at breakfast (08:30-09:00). PAEE was measured throughout via integrated heart-rate and accelerometry monitors. Energy intake was 6% greater on day 1 (260 (344) kcal; P < 0.05) and 14% greater at breakfast on day 3 (223 (59) kcal; P < 0.05) during ER compared to EB. PAEE was 156 (252) kcal lower on day 1 (P < 0.05) and 239 (391) lower on day 2 (P < 0.05) during ER compared to EB. These behavioural compensations meant that the energy deficit produced by 24 h severe energy restriction was attenuated by 1108 (415) kcal (46%) over the study period (P < 0.0001). These results suggest that compensatory changes in energy intake and PAEE occur before, during and after an acute 24 h period of severe energy restriction, likely lessening the energy deficit created.",2020,Energy intake was 6% greater on day 1 (260 (344) kcal; P < 0.05) and 14% greater at breakfast on day 3 (223 (59) kcal; P < 0.05) during ER compared to EB.,"['14 healthy males completed two 48\u202fh trials over 3 days', 'healthy males', '24\u202fh before severe energy restriction']",['Physical activity energy expenditure (PAEE'],"['physical activity energy expenditure', 'Energy intake', 'severe energy restriction', 'PAEE', 'energy intake and PAEE']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",14.0,0.0312231,Energy intake was 6% greater on day 1 (260 (344) kcal; P < 0.05) and 14% greater at breakfast on day 3 (223 (59) kcal; P < 0.05) during ER compared to EB.,"[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'James', 'Affiliation': 'School of Science and Technology, Nottingham Trent University, Nottingham, NG11 8NS, UK.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Clayton', 'Affiliation': 'School of Science and Technology, Nottingham Trent University, Nottingham, NG11 8NS, UK. Electronic address: David.Clayton@ntu.ac.uk.'}]",Appetite,['10.1016/j.appet.2020.104719']
66,32349835,Improving social function with real-world social-cognitive remediation in schizophrenia: Results from the RemedRugby quasi-experimental trial.,"BACKGROUND.


Functional capacity (FC) has been identified as a key outcome to improve real-world functioning in schizophrenia. FC is influenced by cognitive impairments, negative symptoms, self-stigma and reduced physical activity (PA). Psychosocial interventions targeting FC are still under-developed.
METHODS.


we conducted a quasi-experimental study evaluating the effects of an exercise-enriched integrated social cognitive remediation (SCR) intervention (RemedRugby [RR]) compared with an active control group practicing Touch Rugby (TR). To our knowledge, this is the first trial to date evaluating the effectiveness of such a program provided in a real-life environment.
RESULTS.


Eighty-seven people with schizophrenia were included and allocated to either the RR group (n = 57) or the TR group (n = 30) according to the routine clinical practice of the recruiting center. Outcomes were evaluated at baseline and post-treatment in both groups and after 6 months of follow-up in the RR group using standardized scales for symptom severity, social functioning, self-stigma, and a large cognitive battery. After treatment we observed moderate to large improvements in social function (Personal and Social Performance Scale [PSP], p < 0.001, d = 1.255), symptom severity (Positive and Negative Syndrome Scale [PANSS] negative, p < 0.001, d = 0.827; PANSS GP, p < 0.001, d = 0.991; PANSS positive, p = 0.009, d = 0.594), verbal abstraction (p = 0.008, d = 0.554), aggression bias (p = 0.008, d = 0.627), and self-stigma (stereotype endorsement, p = 0.019, d = 0.495; discrimination experiences, p = 0.047; d = 0.389) that were specific to the RR group and were not observed in participants playing only TR. Effects were persistent over time and even larger between post-treatment and follow-up.
CONCLUSIONS.


Exercise-enriched integrated SCR appears promising to improve real-life functioning in schizophrenia. Future research should investigate the potential effects of this intervention on neuroplasticity and physical fitness.",2020,,['schizophrenia'],[],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]",[],[],,0.0119092,,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Dubreucq', 'Affiliation': 'Centre de Neurosciences Cognitive, UMR 5229, CNRS and Université Lyon 1, Lyon, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Gabayet', 'Affiliation': 'Centre Référent de Réhabilitation Psychosociale et de Remédiation cognitive (C3R), Centre Hospitalier Alpes Isère, Grenoble, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Ycart', 'Affiliation': 'Laboratoire Jean Kuntzmann, CNRS UMR 5224, Université Grenoble-Alpes, Grenoble, France.'}, {'ForeName': 'Megane', 'Initials': 'M', 'LastName': 'Faraldo', 'Affiliation': 'Centre Référent de Réhabilitation Psychosociale et de Remédiation cognitive (C3R), Centre Hospitalier Alpes Isère, Grenoble, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Melis', 'Affiliation': 'Centre Référent de Réhabilitation Psychosociale et de Remédiation cognitive (C3R), Centre Hospitalier Alpes Isère, Grenoble, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lucas', 'Affiliation': 'Centre Référent de Réhabilitation Psychosociale et de Remédiation cognitive (C3R), Centre Hospitalier Alpes Isère, Grenoble, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Arnaud', 'Affiliation': 'Centre Hospitalier Sainte Marie de Clermont Ferrand, 33 rue Gabriel Péri, CS 9912, Clermont-Ferrand Cedex 1 63037, France.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Bacconnier', 'Affiliation': ""Centre Médical La Teppe, 25 Avenue de la Bouterne, CS 9721, Tain-l'Hermitage Cedex 26602, France.""}, {'ForeName': 'Motassem', 'Initials': 'M', 'LastName': 'Bakri', 'Affiliation': 'Centre de Réhabilitation Psychosociale et de Remédiation Cognitive (C2R), CH Drôme Vivarais, Montéléger, France.'}, {'ForeName': 'Gentiane', 'Initials': 'G', 'LastName': 'Cambier', 'Affiliation': 'Centre Hospitalier de la Savoie, 89 avenue de Bassens, Bassens73000, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Carmona', 'Affiliation': 'REHALise, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chereau', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Titaua', 'Initials': 'T', 'LastName': 'Challe', 'Affiliation': 'Centre Départemental de Réhabilitation Psychosociale des Glières, 219 Chemin des Bois des Fornets, La Roche sur Foron 74800, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Morel', 'Affiliation': 'Centre de Réhabilitation Psychosociale et de Remédiation Cognitive (C2R), CH Drôme Vivarais, Montéléger, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Pires', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Roussel', 'Affiliation': 'Centre Départemental de Réhabilitation Psychosociale des Glières, 219 Chemin des Bois des Fornets, La Roche sur Foron 74800, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lamy', 'Affiliation': 'REHALise, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Legrand', 'Affiliation': 'Centre Hospitalier Sainte Marie de Clermont Ferrand, 33 rue Gabriel Péri, CS 9912, Clermont-Ferrand Cedex 1 63037, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Pages', 'Affiliation': 'Centre Hospitalier de la Savoie, 89 avenue de Bassens, Bassens73000, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Pommier', 'Affiliation': 'REHALise, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Rey', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Yohan', 'Initials': 'Y', 'LastName': 'Souchet', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Pierre-Michel', 'Initials': 'PM', 'LastName': 'Llorca', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Massoubre', 'Affiliation': 'REHALise, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European psychiatry : the journal of the Association of European Psychiatrists,['10.1192/j.eurpsy.2020.42']
67,32350915,"Cardiac troponin is associated with cardiac outcomes in men and women with atrial fibrillation, insights from the ARISTOTLE trial.","BACKGROUND


Cardiac troponin T (cTnT) and I (cTnI) concentrations provide strong prognostic information in anticoagulated patients with atrial fibrillation (AF). Whether the associations between cardiac troponin concentrations and mortality and morbidity differ by sex is not known.
OBJECTIVES


To assess whether men and women have different concentrations and prognostic value of cTnT and cTnI measurements in anticoagulated patients with AF.
METHODS


cTnT and cTnI concentrations were measured with high-sensitivity (hs) assays in EDTA plasma samples obtained from the multicentre ARISTOTLE trial, which randomized patients with AF and at least one risk factor for stroke or systemic embolic event to warfarin or apixaban. Patients were stratified according to sex and the associations between hs-troponin concentrations, and all-cause death, cardiac death, myocardial infarction, stroke or systemic embolic event and major bleeding were assessed in multivariable regression models.
RESULTS


We found higher cardiac troponin concentrations in men (n = 9649) compared to women (n = 5331), both for hs-cTnT (median 11.8 [Q1-3 8.1-18.0] vs. 9.6 [6.7-14.3] ng L -1  , P < 0.001) and hs-cTnI (5.8 [3.4-10.8] vs. 4.9 [3.1-8.8] ng L -1  , P < 0.001). Adjusting for baseline demographics, comorbidities and medications, men still had significantly higher hs-troponin concentrations than women. C-reactive protein and N-terminal pro-B-type natriuretic peptide concentrations were higher in female patients. Both hs-cTnT and hs-cTnI concentrations were associated with all clinical outcomes similarly in men and women (p-value for interaction >0.05 for all end-points).
CONCLUSION


Men have higher hs-troponin concentrations than women in AF. Regardless of sex, hs-troponin concentrations remain similarly associated with adverse clinical outcomes in anticoagulated patients with AF.",2020,"We found higher cardiac troponin concentrations in men (n=9649) compared to women (n=5331), both for hs-cTnT","['female patients', 'anticoagulated patients with atrial fibrillation (AF', 'men (n=9649) compared to women (n=5331), both for hs-cTnT', 'patients with AF and at least one risk factor for stroke or systemic embolic event to warfarin or apixaban', 'anticoagulated patients with AF', 'men and women with atrial fibrillation']","['cTnT', 'Cardiac troponin', 'Cardiac troponin T ']","['higher hs-troponin concentrations', 'cardiac troponin concentrations', 'troponin concentrations and all-cause death, cardiac death, myocardial infarction, stroke or systemic embolic event, and major bleeding', 'and cTnI concentrations', 'C-reactive protein and N-terminal pro-B-type natriuretic peptide concentrations', 'hs-troponin concentrations']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]",,0.343636,"We found higher cardiac troponin concentrations in men (n=9649) compared to women (n=5331), both for hs-cTnT","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Røsjø', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Hijazi', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Omland', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Westerbergh', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Lyngbakken', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke Health, Durham, NC, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Gersh', 'Affiliation': 'Mayo Clinic College of Medicine, Rochester, MN, USA.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke Health, Durham, NC, USA.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Hylek', 'Affiliation': 'Boston University Medical Center, Boston, MA, USA.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke Health, Durham, NC, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Siegbahn', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.'}]",Journal of internal medicine,['10.1111/joim.13072']
68,32353174,Physical activity and cognition in young-onset Parkinson's disease.,"BACKGROUND


A relationship has been observed between physical activity and cognition in older-onset Parkinson's disease, as well as improvements in cognition after a physical activity intervention. To date, this has not been investigated in young-onset Parkinson's disease (YOPD).
OBJECTIVES


To examine the baseline relationship between physical activity and cognition in YOPD; and to examine whether a physical activity intervention can improve cognition in YOPD.
METHODS


Two interrelated online studies were conducted. In the first study, 132 participants with YOPD completed self-reported measures of physical activity, and objective and subjective measures of cognition. A subset of 38 participants was then randomly allocated to either a six-week physical activity intervention or control condition. Following the intervention, participants repeated the objective and subjective cognitive measures.
RESULTS


No relationship was found between self-reported physical activity and objective cognition; however, there was a relationship between physical activity and subjective cognition. Similarly, following the intervention subjective improvements were found for concentration, attention, and processing speed, but not for memory. Furthermore, medium effect sizes were evident for objective measures of processing speed and small-medium effect sizes for planning and cognitive flexibility, although statistical significance was not reached.
CONCLUSIONS


In this first study investigating physical activity and cognition in YOPD, the results suggest that increased physical activity relates to improved processing speed and attention. Replication is recommended with a larger sample size. A longer, more intense physical activity manipulation and utilizing the study's strengths of online recruitment and intervention delivery are also recommended.",2020,"Similarly, following the intervention subjective improvements were found for concentration, attention, and processing speed, but not memory.","['38 participants', ""young onset Parkinson's disease (YOPD"", ""young onset Parkinson's disease"", '132 participants with YOPD completed']","['physical activity intervention', 'six-week physical activity intervention or control condition']","['physical activity and objective cognition', 'Physical activity and cognition', 'physical activity and subjective cognition', 'processing speed and small-medium effect sizes for planning and cognitive flexibility', 'objective and subjective cognitive measures', 'self-report measures of physical activity, and objective and subjective measures of cognition', 'concentration, attention, and processing speed, but not memory']","[{'cui': 'C4275179', 'cui_str': 'Young onset Parkinson disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",132.0,0.0152447,"Similarly, following the intervention subjective improvements were found for concentration, attention, and processing speed, but not memory.","[{'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Biddiscombe', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Ong', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Kalinowski', 'Affiliation': 'Cogstate, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kerryn E', 'Initials': 'KE', 'LastName': 'Pike', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}]",Acta neurologica Scandinavica,['10.1111/ane.13256']
69,32353645,Effectiveness of simulation learning program for mastering public health nursing skills to enhance strength of community: A quasi-experimental design.,"PURPOSE


The purpose of this study is to develop a simulation learning program for mastering public health nursing skills to enhance strength of community, and to verify its effectiveness.
METHODS


The program is one-day session to master the skills from three exercises. This study adopts a quasi-experimental design. We selected unbiased 34 participants in intervention group and 30 participants in control group, and conducted self-administered questionnaire surveys at three points in time: pre, post 1 and post 2. Three tools were used to measure the required outcome. For the outcome evaluation, we calculated the changes in the mean value of each tool between pre and post 1 and between pre and post 2, and compared them between the two groups.
RESULTS


The change of intervention group in the total score at the post 1 stage from the pre stage was significantly higher than control group regarding each of the scales (P < .05).
CONCLUSIONS


The program was found to be effective in upgrading the skills of less-experienced public health nurses to enhance strength of community.",2020,The program was found to be effective in upgrading the skills of less-experienced public health nurses to enhance strength of community.,"['mastering public health nursing skills to enhance strength of community', '34 participants in intervention group and 30 participants in control group, and conducted self-administered questionnaire surveys at three points in time: pre, post 1 and post 2']",['simulation learning program'],['total score'],"[{'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0034023', 'cui_str': 'Nursing, Public Health'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439547', 'cui_str': 'Points in time'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0086858', 'cui_str': 'Programmed Learning'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",34.0,0.015403,The program was found to be effective in upgrading the skills of less-experienced public health nurses to enhance strength of community.,"[{'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Okamoto', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan. Electronic address: reiko@sahs.med.osaka-u.ac.jp.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Gouda', 'Affiliation': ""Faculty of Nursing and Rehabilitation, Konan Women's University, Japan.""}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Koide', 'Affiliation': 'Faculty of Nursing, Shitennouji University, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Tokimasa', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Kageyama', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Saori', 'Initials': 'S', 'LastName': 'Iwamoto', 'Affiliation': 'Faculty of Nursing, Kobe City College of Nursing, Japan.'}, {'ForeName': 'Misa', 'Initials': 'M', 'LastName': 'Shiomi', 'Affiliation': 'Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Kusano', 'Affiliation': 'Faculty of Nursing, Osaka Medical College, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Misaki', 'Initials': 'M', 'LastName': 'Kiya', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Aoki', 'Initials': 'A', 'LastName': 'Tada', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Hanayo', 'Initials': 'H', 'LastName': 'Koetaka', 'Affiliation': ""Faculty of Nursing and Rehabilitation, Konan Women's University, Japan.""}]",Nurse education today,['10.1016/j.nedt.2020.104432']
70,32353739,Real time SVD-based clutter filtering using randomized singular value decomposition and spatial downsampling for micro-vessel imaging on a Verasonics ultrasound system.,"Singular value decomposition (SVD)-based clutter filters can robustly reject the tissue clutter as compared with the conventional high pass filter-based clutter filters. However, the computational burden of SVD makes real time SVD-based clutter filtering challenging (e.g. frame rate at least 10-15 Hz with region of interest of about 4 × 4 cm 2 ). Recently, we proposed an acceleration method based on randomized SVD (rSVD) clutter filtering and randomized spatial downsampling, which can significantly reduce the computational complexity without compromising the clutter rejection capability. However, this method has not been implemented on an ultrasound scanner and tested for its performance. In this study, we implement this acceleration method on a Verasonics scanner using a multi-core CPU architecture, and evaluate the selections of the imaging and processing parameters to enable real time micro-vessel imaging. The Blood-to-Clutter Ratio (BCR) performance was evaluated on a Verasonics machine with different settings of parameters such as block size and ensemble size. The demonstration of real time process was implemented on a 12-core CPU (downsampling factor of 12, 12-threads in this study) host computer. The processing time of the rSVD-based clutter filter was less than 30 ms and BCRs were higher than 20 dB as the block size, ensemble size and the rank of tissue clutter subspace were set as 30 × 30, 45 and 26 respectively. We also demonstrate that the micro-vessel imaging frame rate of the proposed architecture can reach approximately 22 Hz when the block size, ensemble size and the rank of tissue clutter subspace were set as 20 × 20 pixels, 45 and 26 respectively (using both images and supplementary videos). The proposed method may be important for real time 2D scanning of tumor microvessels in 3D to select and store the most representative 2D view with most abnormal micro-vessels for better diagnosis.",2020,"The processing time of the rSVD-based clutter filter was less than 30 ms and BCRs were higher than 20 dB as the block size, ensemble size and the rank of tissue clutter subspace were set as 30 × 30, 45 and 26 respectively.",[],[],"['Blood-to-Clutter Ratio (BCR) performance', 'processing time of the rSVD-based clutter filter']",[],[],"[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0009090', 'cui_str': 'Cluttering'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039010', 'cui_str': 'Swine Vesicular Disease'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0180860', 'cui_str': 'Filter'}]",,0.0321407,"The processing time of the rSVD-based clutter filter was less than 30 ms and BCRs were higher than 20 dB as the block size, ensemble size and the rank of tissue clutter subspace were set as 30 × 30, 45 and 26 respectively.","[{'ForeName': 'U-Wai', 'Initials': 'UW', 'LastName': 'Lok', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Trzasko', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Daigle', 'Affiliation': 'Verasonics Inc., Kirkland, WA, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Borisch', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Chengwu', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Gong', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Wenwu', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Department of Ultrasound, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Shigao', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA. Electronic address: Chen.Shigao@mayo.edu.'}]",Ultrasonics,['10.1016/j.ultras.2020.106163']
71,32353805,"Sugammadex versus neostigmine for reversal of rocuronium-induced neuromuscular blockade: A randomized, double-blinded study of thoracic surgical patients evaluating hypoxic episodes in the early postoperative period.","STUDY OBJECTIVE


This objective of this study was to determine if reversal of rocuronium-induced neuromuscular blockade with sugammadex versus neostigmine results in a decreased number of hypoxic episodes in the early postoperative period in patients undergoing thoracic surgery with single lung ventilation.
DESIGN


Single-center, randomized, double-blind, two-arm clinical trial.
SETTING


Operating room and postanesthesia care unit.
PATIENTS


92 subjects aged ≥18, American Society of Anesthesiologists physical status II-IV, and undergoing a thoracic operation necessitating single lung ventilation.
INTERVENTIONS


Subjects received either 2 mg/kg sugammadex or 50 μg/kg neostigmine with 8 μg/kg glycopyrrolate for reversal of moderate neuromuscular blockade.
MEASUREMENTS


For the first 90 min postoperatively, all episodes of hypoxia were recorded. Neuromuscular monitoring was performed with acceleromyography (TOF-Watch® SX) and the train of four (TOF) was recorded at 2, 5, 10, and 15 min after administration of the neuromuscular reversal agent.
MAIN RESULTS


Subjects who received neostigmine had a median of 1 episode (interquartile range IQR: 0-2.2) of hypoxia versus subjects who received sugammadex who had a median of 0 episodes (IQR: 0-1) (p = 0.009). The mean time to recovery of TOF ≥ 0.9 was significantly faster with sugammadex at 10 min (95% confidence interval CI: 5-15) compared with neostigmine at 40 min (95% CI: 15-53) (p < 0.001).
CONCLUSIONS


In thoracic surgical patients necessitating single lung ventilation, sugammadex provides faster reversal of moderate neuromuscular blockade and results in a decreased number of postoperative hypoxic episodes compared with neostigmine.",2020,"The mean time to recovery of TOF ≥ 0.9 was significantly faster with sugammadex at 10 min (95% confidence interval CI: 5-15) compared with neostigmine at 40 min (95% CI: 15-53) (p < 0.001).
","['Operating room and postanesthesia care unit', 'patients undergoing thoracic surgery with single lung ventilation', '92 subjects aged ≥18, American Society of Anesthesiologists physical status II-IV, and undergoing a thoracic operation necessitating single lung ventilation', 'thoracic surgical patients evaluating hypoxic episodes in the early postoperative period', 'induced neuromuscular blockade']","['Sugammadex versus neostigmine', 'rocuronium', 'acceleromyography (TOF-Watch® SX', 'neostigmine', '2\xa0mg/kg sugammadex or 50\xa0μg/kg neostigmine with 8\xa0μg/kg glycopyrrolate', 'sugammadex versus neostigmine']","['episodes of hypoxia', 'hypoxic episodes', 'median of 1 episode', 'postoperative hypoxic episodes', 'mean time to recovery of TOF\xa0≥']","[{'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0524832', 'cui_str': 'Surgical procedure on thorax'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C3805242', 'cui_str': 'Acceleromyography'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]",92.0,0.706447,"The mean time to recovery of TOF ≥ 0.9 was significantly faster with sugammadex at 10 min (95% confidence interval CI: 5-15) compared with neostigmine at 40 min (95% CI: 15-53) (p < 0.001).
","[{'ForeName': 'Tiffany S', 'Initials': 'TS', 'LastName': 'Moon', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA. Electronic address: Tiffany.Moon@UTSouthwestern.edu.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Reznik', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Cardiovascular and Thoracic Surgery, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Pak', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Jan', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Pruszynski', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Cardiovascular and Thoracic Surgery, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Kim', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Katelynn M', 'Initials': 'KM', 'LastName': 'Smith', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Lu', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Gasanova', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Pamela E', 'Initials': 'PE', 'LastName': 'Fox', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Babatunde', 'Initials': 'B', 'LastName': 'Ogunnaike', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109804']
72,32355959,Corticospinal-motor neuronal plasticity promotes exercise-mediated recovery in humans with spinal cord injury.,"Rehabilitative exercise in humans with spinal cord injury aims to engage residual neural networks to improve functional recovery. We hypothesized that exercise combined with non-invasive stimulation targeting spinal synapses further promotes functional recovery. Twenty-five individuals with chronic incomplete cervical, thoracic, and lumbar spinal cord injury were randomly assigned to 10 sessions of exercise combined with paired corticospinal-motor neuronal stimulation (PCMS) or sham-PCMS. In an additional experiment, we tested the effect of PCMS without exercise in 13 individuals with spinal cord injury with similar characteristics. During PCMS, 180 pairs of stimuli were timed to have corticospinal volleys evoked by transcranial magnetic stimulation over the primary motor cortex arrive at corticospinal-motor neuronal synapses of upper- or lower-limb muscles (depending on the injury level), 1-2 ms before antidromic potentials were elicited in motor neurons by electrical stimulation of a peripheral nerve. Participants exercised for 45 min after all protocols. We found that the time to complete subcomponents of the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) and the 10-m walk test decreased on average by 20% after all protocols. However, the amplitude of corticospinal responses elicited by transcranial magnetic stimulation and the magnitude of maximal voluntary contractions in targeted muscles increased on overage by 40-50% after PCMS combined or not with exercise but not after sham-PCMS combined with exercise. Notably, behavioural and physiological effects were preserved 6 months after the intervention in the group receiving exercise with PCMS but not in the group receiving exercise combined with sham-PCMS, suggesting that the stimulation contributed to preserve exercise gains. Our findings indicate that targeted non-invasive stimulation of spinal synapses might represent an effective strategy to facilitate exercise-mediated recovery in humans with different degrees of paralysis and levels of spinal cord injury.",2020,"Notably, behavioural and physiological effects were preserved 6 months after the intervention in the group receiving exercise with PCMS but not in the group receiving exercise combined with sham-PCMS, suggesting that the stimulation contributed to preserve exercise gains.","['humans with spinal cord injury', '13 individuals with spinal cord injury with similar characteristics', 'Twenty-five individuals with chronic incomplete cervical, thoracic, and lumbar spinal cord injury']","['PCMS without exercise', 'exercise combined with paired corticospinal-motor neuronal stimulation (PCMS) or sham-PCMS', 'Corticospinal-motor neuronal plasticity promotes exercise', 'Rehabilitative exercise', 'exercise combined with sham-PCMS']","['time to complete subcomponents of the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) and the 10-m walk test', 'behavioural and physiological effects']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0457848', 'cui_str': 'Segment of lumbar spinal cord'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.223458,"Notably, behavioural and physiological effects were preserved 6 months after the intervention in the group receiving exercise with PCMS but not in the group receiving exercise combined with sham-PCMS, suggesting that the stimulation contributed to preserve exercise gains.","[{'ForeName': 'Hang Jin', 'Initials': 'HJ', 'LastName': 'Jo', 'Affiliation': 'University of Miami, Department of Neurological Surgery, The Miami Project to Cure Paralysis, and Bruce W. Carter Department of Veterans Affairs Medical Center, Miami, FL, USA.'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'Perez', 'Affiliation': 'University of Miami, Department of Neurological Surgery, The Miami Project to Cure Paralysis, and Bruce W. Carter Department of Veterans Affairs Medical Center, Miami, FL, USA.'}]",Brain : a journal of neurology,['10.1093/brain/awaa052']
73,32356465,Phase II open-label study investigating apalutamide in patients with biochemical progression after radical prostatectomy.,"Apalutamide, a competent inhibitor of the androgen receptor, has shown promising clinical efficacy results for patients with advanced prostate cancer. Here, we describe the rationale and design for the SAVE trial, a multi-center, Phase II study, wherein 202 men with biochemical progression after radical prostatectomy are randomly assigned 1:1 to apalutamide plus salvage radiotherapy (SRT) or androgen-deprivation therapy with an luteinizing hormone-releasing hormone agonist or antagonist plus SRT. The primary objective is to compare sexual function between the two treatment arms based on the expanded prostate cancer index-26 sexual domain score at nine months after start of hormonal treatment. The key secondary objectives are to assess quality of life, to evaluate the safety profile and the short-term efficacy of apalutamide in combination with SRT.  ClinicalTrials.gov identifier:  NCT03899077.",2020,The primary objective is to compare sexual function between the two treatment arms based on the expanded prostate cancer index-26 sexual domain score at nine months after start of hormonal treatment.,"['202 men with biochemical progression after radical prostatectomy', 'patients with advanced prostate cancer', 'patients with biochemical progression after radical prostatectomy']",['apalutamide plus salvage radiotherapy (SRT) or androgen-deprivation therapy with an luteinizing hormone-releasing hormone agonist or antagonist plus SRT'],"['quality of life', 'sexual function', 'expanded prostate cancer index-26 sexual domain score']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",202.0,0.0290767,The primary objective is to compare sexual function between the two treatment arms based on the expanded prostate cancer index-26 sexual domain score at nine months after start of hormonal treatment.,"[{'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Dirix', 'Affiliation': 'Department of Radiation Oncology, Iridium Kankernetwerk, Antwerp, Belgium.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Strijbos', 'Affiliation': 'Department of Medical Oncology, GZA Sint-Augustinus Hospital, Antwerp, Belgium.'}, {'ForeName': 'Tom Van', 'Initials': 'TV', 'LastName': 'den Mooter', 'Affiliation': 'Department of Medical Oncology, GZA Sint-Augustinus Hospital, Antwerp, Belgium.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Liefhooghe', 'Affiliation': 'Department of Radiation Oncology, AZ Groeninge, Kortrijk, Belgium.'}, {'ForeName': 'Siska Van', 'Initials': 'SV', 'LastName': 'Bruwaene', 'Affiliation': 'Department of Urology, AZ Groeninge, Kortrijk, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Uvin', 'Affiliation': 'Department of Urology, AZ Sint-Jan, Bruges, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Ghysel', 'Affiliation': 'Department of Urology, AZ Sint-Jan, Bruges, Belgium.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Ost', 'Affiliation': 'Department of Urology, AZ Sint-Blasius, Dendermonde, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schatteman', 'Affiliation': 'Department of Urology, OLV, Aalst, Belgium.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bral', 'Affiliation': 'Department of Radiation Oncology, OLV, Aalst, Belgium.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Engels', 'Affiliation': 'Department of Radiation Oncology, UZ Brussel, Brussels, Belgium.'}, {'ForeName': 'Robbe Van', 'Initials': 'RV', 'LastName': 'den Begin', 'Affiliation': 'Department of Radiation Oncology, Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Otte', 'Affiliation': 'Department of Radiation Oncology, Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Roumeguere', 'Affiliation': 'Department of Urology, Hôpital Erasme, Brussels, Belgium.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Palumbo', 'Affiliation': 'Department of Radiation Oncology, Hôpital Sainte Elisabeth, Namur, Belgium.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Neybuch', 'Affiliation': 'Department of Radiation Oncology, Hôpital Jolimont, La Louvière, Belgium.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Fonteyne', 'Affiliation': 'Department of Radiation Oncology, UZ Gent, Ghent, Belgium.'}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Ost', 'Affiliation': 'Department of Radiation Oncology, UZ Gent, Ghent, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Dirix', 'Affiliation': 'Department of Medical Oncology, GZA Sint-Augustinus Hospital, Antwerp, Belgium.'}]","Future oncology (London, England)",['10.2217/fon-2020-0056']
74,32356470,Postoperative analgesia and opioid use following hip arthroscopy with ultrasound-guided quadratus lumborum block: a randomized controlled double-blind trial.,"OBJECTIVE


To investigate the postoperative analgesic effect of ultrasound-guided quadratus lumborum block (QLB) in patients undergoing arthroscopic hip surgery.
METHODS


Patients who were scheduled to undergo elective arthroscopic hip surgery were randomly assigned to the QLB (Q) or control (C) group (n = 40 each). After general anesthesia induction, unilateral QLB was performed under ultrasound guidance in the Q group. The amount of opioid use via patient-controlled analgesia (PCA) and the resting and movement pain visual analog scale (VAS) scores when the patient left the postanesthesia care unit (PACU) and 4, 8, 12, and 24 hours after surgery were recorded. Postoperative complications were recorded for both groups.
RESULTS


At 24 hours post-surgery, opioid consumption amounts via PCA (48.4 [48.1-48.6] mL) in the Q group were significantly lower compared with the C group (52.0 [51.0-53.8] mL). A significant reduction in opioid consumption was observed between the two groups at each time point. Resting and movement VAS scores at each time point were significantly lower in the Q compared with the C group.
CONCLUSIONS


Hip arthroscopy patients who received QLB and general anesthesia in combination had less pain and a lower opioid requirement within 24 hours postoperatively.",2020,"Resting and movement VAS scores at each time point were significantly lower in the Q compared with the C group.
","['patients undergoing arthroscopic hip surgery', 'Patients who were scheduled to undergo elective arthroscopic hip surgery', 'Hip arthroscopy patients']","['QLB', 'ultrasound-guided quadratus lumborum block (QLB', 'QLB (Q) or control (C', 'hip arthroscopy with ultrasound-guided quadratus lumborum block']","['resting and movement pain visual analog scale (VAS) scores', 'Postoperative complications', 'opioid consumption', 'pain and a lower opioid requirement', 'Resting and movement VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0186190', 'cui_str': 'Diagnostic arthroscopy of hip joint'}]","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0186190', 'cui_str': 'Diagnostic arthroscopy of hip joint'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.0870454,"Resting and movement VAS scores at each time point were significantly lower in the Q compared with the C group.
","[{'ForeName': 'Liangjing', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Chengshi', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Anshi', 'Initials': 'A', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}]",The Journal of international medical research,['10.1177/0300060520920996']
75,32358836,Cost-effectiveness evaluation of the PROPPR trial transfusion protocols.,"BACKGROUND


There have been no prior investigations of the cost effectiveness of transfusion strategies for trauma resuscitation. The Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (PROPPR) study was a Phase III multisite, randomized trial in 680 subjects comparing the efficacy of 1:1:1 transfusion ratios of plasma and platelets to red blood cells with the 1:1:2 ratio. We hypothesized that 1:1:1 transfusion results in an acceptable incremental cost-effectiveness ratio, when estimated using patients' age-specific life expectancy and cost of care during the 30-day PROPPR trial period.
STUDY DESIGN AND METHODS


International Classification of Diseases, Ninth Revision codes were prospectively collected, and subjects were matched 1:2 to subjects in the Healthcare Utilization Program State Inpatient Data to estimate cost weights. We used a decision tree analysis, combined with standard costs and estimated years of expected survival to determine the cost effectiveness of the two treatments.
RESULTS


The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006). For every 100 patients treated in the 1:1:1 group, eight more achieved hemostasis than in the 1:1:2 group. At 30 days, the total hospital cost per 100 patients was $5.6 million in the 1:1:1 group compared with $5.0 million in the 1:1:2 group. For each 100 patients, the 1:1:1 group had 218.5 more years of life expectancy. This was at a cost of $2994 per year gained.
CONCLUSION


The 1:1:1 transfusion ratio in severely injured hemorrhaging trauma patients is a very cost-effective strategy for increasing hemostasis and decreasing trauma deaths.",2020,The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006).,"['severely injured hemorrhaging trauma patients', '680 subjects', 'International Classification of Diseases, Ninth Revision codes were prospectively collected, and subjects were matched 1:2 to subjects in the Healthcare Utilization Program State Inpatient Data to estimate cost weights']",[],"['hemostasis', 'overall costs', 'hemorrhagic death', 'total hospital cost', 'life expectancy']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",[],"[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",680.0,0.0809202,The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006).,"[{'ForeName': 'Rachael A', 'Initials': 'RA', 'LastName': 'Callcut', 'Affiliation': 'Division of General Surgery, Department of Surgery, School of Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Kit N', 'Initials': 'KN', 'LastName': 'Simpson', 'Affiliation': 'Department of Healthcare Leadership & Management, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baraniuk', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': 'Center for Translational Injury Research and Department of Surgery, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Tilley', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, Center for Injury Science, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transfusion,['10.1111/trf.15784']
76,32361220,Clinical impact of lung ultrasound monitoring for diagnosis of ventilator associated pneumonia: A diagnostic randomized controlled trial.,"PURPOSE


Studies have shown that lung-ultrasound may be superior to chest x-ray (CXR) in diagnosing ventilator-associated pneumonia (VAP). This study investigated whether the use of lung-ultrasound monitoring could detect VAP earlier and improve patient outcome.
METHODS


This was a single-center diagnostic randomized controlled trial. In the control group, VAP was diagnosed using a combination of CXR and clinical findings. In the intervention group, VAP was diagnosed using a combination of lung-ultrasound and clinical findings. The primary outcome measured was ventilator free days (VFD). Secondary outcomes were ICU mortality, length of stay in ICU, change in Sequential Organ Failure Score at day 4 compared to day 0 (delta SOFA), antibiotic duration and ventilator days.
RESULTS


We randomized intubated patients until 44 VAP diagnosis was made in each group. VFD was higher in the intervention group than in the control group (7.80+/- 9.7 days versus 3.7+/- 6.4 days, p = .044). There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70).
CONCLUSION


The use of lung-ultrasound monitoring for diagnosis of VAP improves patient outcome when compared to the standard diagnostic strategy that relies on CXR.",2020,"There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70).
",['diagnosis of ventilator associated pneumonia'],"['VAP', 'lung ultrasound monitoring', 'lung-ultrasound monitoring']","['ICU length of stay', 'delta SOFA', 'ICU mortality, length of stay in ICU, change in Sequential Organ Failure Score at day 4 compared to day 0 (delta SOFA), antibiotic duration and ventilator days', 'ICU mortality', 'antibiotic duration', 'ventilator free days (VFD', 'VFD']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3494460', 'cui_str': 'Organ Failure Scores'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.170703,"There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70).
","[{'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Pradhan', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal. Electronic address: saurabh_44@hotmail.com.'}, {'ForeName': 'Pramesh Sunder', 'Initials': 'PS', 'LastName': 'Shrestha', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}, {'ForeName': 'Gentle Sunder', 'Initials': 'GS', 'LastName': 'Shrestha', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}, {'ForeName': 'Moda Nath', 'Initials': 'MN', 'LastName': 'Marhatta', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}]",Journal of critical care,['10.1016/j.jcrc.2020.03.012']
77,32361223,Comparison of programmed intermittent epidural bolus and continuous epidural infusion for post-operative analgesia after major abdominal surgery: A randomized controlled trial.,"STUDY OBJECTIVE


Few studies have compared continuous epidural infusion (CEI) against programmed intermittent epidural bolus (PIEB) epidural analgesia after major abdominal surgery. It has not been established whether the modality of epidural medication administration affects postoperative pain and other patient outcomes. The goal of this study was to compare the efficacy of PIEB against CEI in postoperative pain management after a broad range of surgeries with abdominal incisions, all managed in the context of an established enhanced recovery after surgery (ERAS) pathway.
DESIGN


Prospective, randomized, controlled trial.
SETTING


Postoperative acute care.
PATIENTS


120 patients scheduled for major surgery involving abdominal incisions with planned postoperative epidural analgesia were enrolled as study participants.
INTERVENTIONS


All subjects received a standardized epidural solution containing ropivacaine 0.0625% and fentanyl 2 μg/ml. The CEI group received this solution as a continuous infusion, while the PIEB group received this solution as programmed intermittent boluses.
MEASUREMENTS


The primary study outcome was the total local anesthetic used over the first 24 h post-operatively. Secondary outcomes included pain severity, pain interference, total opioid consumption, patient satisfaction, and adverse effects at 24, 48, and 72 h postoperatively.
MAIN RESULTS


There was no difference in the primary outcome of total amount of local anesthetic administered in the first 24-hour postoperative period (PIEB: 123 mg [Interquartile Range (IQR): 114-136]; CEI: 126 mg [IQR: 120-134]). There were also no differences in average pain severity, total opioid consumption, patient satisfaction, number of PCEA requests and incidence of adverse events at 24, 48, and 72 h postoperatively.
CONCLUSIONS


Our study suggests that within the context of an established ERAS program, PIEB and CEI modes of epidural analgesia can be equally efficacious and safe in providing postoperative analgesia after major abdominal surgery.",2020,There was no difference in the primary outcome of total amount of local anesthetic administered in the first 24-hour postoperative period (PIEB:,"['post-operative analgesia after major abdominal surgery', '120 patients scheduled for major surgery involving abdominal incisions with planned postoperative epidural analgesia were enrolled as study participants']","['PIEB against CEI', 'standardized epidural solution containing ropivacaine', 'continuous epidural infusion', 'CEI']","['total amount of local anesthetic administered in the first 24-hour postoperative period (PIEB', 'total local anesthetic used over the first 24\xa0h post-operatively', 'average pain severity, total opioid consumption, patient satisfaction, number of PCEA requests and incidence of adverse events', 'pain severity, pain interference, total opioid consumption, patient satisfaction, and adverse effects']","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0198488', 'cui_str': 'Abdomen incision'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",120.0,0.371242,There was no difference in the primary outcome of total amount of local anesthetic administered in the first 24-hour postoperative period (PIEB:,"[{'ForeName': 'Po-Yi Paul', 'Initials': 'PP', 'LastName': 'Su', 'Affiliation': 'University of California San Francisco, United States of America. Electronic address: paul.su@ucsf.edu.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Peniche', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Elle', 'Initials': 'E', 'LastName': 'Clelland', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ladd', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Delgado', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Lee-Lynn', 'Initials': 'LL', 'LastName': 'Chen', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Claas', 'Initials': 'C', 'LastName': 'Siegmueller', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Latronica', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Ramana', 'Initials': 'R', 'LastName': 'Naidu', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Aleshi', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Behrends', 'Affiliation': 'University of California San Francisco, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109850']
78,32361279,Radial versus femoral access for percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction: Trial sequential analysis.,"BACKGROUND


Randomized controlled trials (RCTs) have yielded conflicting results about the impact of transradial access (TRA) versus transfemoral access (TFA) in patients with ST-segment elevation myocardial infarction (STEMI).
METHODS


We performed a trial sequential analysis (TSA) of RCTs comparing TRA and TFA in patients with STEMI. The outcomes of interest were 30-day mortality, major bleeding, major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and access site complications.
RESULTS


A total of 17 studies with 11,992 patients were included in the current TSA. The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001). There was no difference in MI and stroke between the 2groups. Applying TSA boundaries, the z-curve for 30-day mortality, major bleeding, MACE and access site complications crossed the conventional and the TSA boundaries, indicating firm evidence for better outcomes in the TRA group. For MI and stroke, the z-curve failed to cross the conventional and the TSA boundaries for both outcomes, indicating lack of signals of benefit or harm.
CONCLUSIONS


In the current TSA, the available data from RCTs support improved 30-day mortality, major bleeding, MACE and access site complication rates in STEMI patients treated by PCI through the radial access.",2020,"The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001).","['A total of 17 studies with 11,992 patients were included in the current TSA', 'patients with STEMI', 'patients with ST-segment elevation myocardial infarction (STEMI', 'patients with ST-segment elevation myocardial infarction']","['TRA', 'transradial access (TRA) versus transfemoral access (TFA', 'percutaneous coronary intervention', 'Radial versus femoral access']","['MI and stroke', '30-day mortality, major bleeding, MACE and access site complication rates', '30-day mortality, major bleeding, major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and access site complications', 'major bleeding', '30-day mortality', 'access site complications']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",11992.0,0.316525,"The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001).","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Osman', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA. Electronic address: Mohammed.Osman@hsc.wvu.edu.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saleem', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Khansa', 'Initials': 'K', 'LastName': 'Osman', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Babikir', 'Initials': 'B', 'LastName': 'Kheiri', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Regner', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Qais', 'Initials': 'Q', 'LastName': 'Radaideh', 'Affiliation': 'Division of Internal Medicine, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Moreland', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Rao', 'Affiliation': 'Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Kapadia', 'Affiliation': 'Heart and Vascular Institute, Department of Cardiovascular Medicine, Cleveland Clinic, OH, USA.'}]",American heart journal,['10.1016/j.ahj.2020.03.014']
79,32364879,Pro-Con Perspectives on Ethics in Surgical Research: Update from the 39th Annual Surgical Infection Society Meeting.,"Background:  Surgical research is potentially invasive, high-risk, and costly. Research that advances medical dogma must justify both its ends and its means. Although ethical questions do not always have simple answers, it is critically important for the clinician, researcher, and patient to approach these dilemmas and surgical research in a thoughtful, conscientious manner.  Methods:  We present four ethical issues in surgical research and discuss the opposing viewpoints. These topics were presented and discussed at the 39th Annual Meeting of the Surgical Infection Society as pro-con debates. The presenters of each opinion developed a succinct summary of their respective reviews for this publication.  Results:  The key subjects for these pro-con debates were: (1) Should patients be enrolled for time-sensitive surgical infection research using an opt-out or an opt-in strategy? (2) Should patients who are being enrolled in a randomized controlled trial (RCT) comparing surgery with a non-operative intervention pay the costs of their treatment arm? (3) Should the scientific community embrace open access journals as the future of scientific publishing? (4) Should the majority of funding go to clinical or basic science research? Important points were illustrated in each of the pro-con presentations and illustrated the difficulties that are facing the performance and payment of infection research in the future.  Conclusions:  Surgical research is ethically complex, with conflicting demands between individual patients, society, and healthcare economics. At present, there are no clear answers to these and the many other ethical issues facing research in the future. Answers will only come from continued robust dialogue among all stakeholders in surgical research.",2020,Important points were illustrated in each of the pro-con presentations and illustrated the difficulties that are facing the performance and payment of infection research in the future.  ,['Surgical Research'],[],[],"[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]",[],[],4.0,0.0241724,Important points were illustrated in each of the pro-con presentations and illustrated the difficulties that are facing the performance and payment of infection research in the future.  ,"[{'ForeName': 'Vanessa P', 'Initials': 'VP', 'LastName': 'Ho', 'Affiliation': 'Department of Surgery, MetroHealth Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Evelyn I', 'Initials': 'EI', 'LastName': 'Truong', 'Affiliation': 'Department of Surgery, MetroHealth Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Saira', 'Initials': 'S', 'LastName': 'Nisar', 'Affiliation': 'The Burn Center, Medstar Washington Hospital Center, Department of Surgery, Georgetown University School of Medicine, Washington, DC, USA.'}, {'ForeName': 'Addison K', 'Initials': 'AK', 'LastName': 'May', 'Affiliation': 'Department of Surgery, Carolinas Medical Center, Atrium Health, Charlotte, North Carolina, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Beilman', 'Affiliation': 'Department of Surgery, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Fry', 'Affiliation': 'Department of Surgery, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Barie', 'Affiliation': 'Departments of Surgery and Public Health, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Huston', 'Affiliation': 'Departments of Surgery and Science Education, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Shupp', 'Affiliation': 'The Burn Center, Medstar Washington Hospital Center, Department of Surgery, Georgetown University School of Medicine, Washington, DC, USA.'}, {'ForeName': 'Fredric M', 'Initials': 'FM', 'LastName': 'Pieracci', 'Affiliation': 'Department of Surgery, Denver Health Medical Center/University of Colorado School of Medicine, Denver, Colorado, USA.'}]",Surgical infections,['10.1089/sur.2020.098']
80,32366486,External heated humidification during non-invasive ventilation set up: results from a pilot cross-over clinical trial.,,2020,,[],['External Heated Humidification'],[],[],"[{'cui': 'C0205101', 'cui_str': 'External'}]",[],,0.0279443,,"[{'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Mandal', 'Affiliation': ""Lane Fox Clinical Respiratory Physiology Research Centre, St Thomas' Hospital, King's Health Partners, London, UK.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Ramsay', 'Affiliation': ""Lane Fox Clinical Respiratory Physiology Research Centre, St Thomas' Hospital, King's Health Partners, London, UK.""}, {'ForeName': 'Eui-Sik', 'Initials': 'ES', 'LastName': 'Suh', 'Affiliation': ""Lane Fox Clinical Respiratory Physiology Research Centre, St Thomas' Hospital, King's Health Partners, London, UK.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Harding', 'Affiliation': ""Lane Fox Clinical Respiratory Physiology Research Centre, St Thomas' Hospital, King's Health Partners, London, UK.""}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': ""Lane Fox Clinical Respiratory Physiology Research Centre, St Thomas' Hospital, King's Health Partners, London, UK.""}, {'ForeName': 'Abdel', 'Initials': 'A', 'LastName': 'Douiri', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Moxham', 'Affiliation': ""King's College London, School of Life Sciences, Centre for Human and Applied Physiological, London, UK.""}, {'ForeName': 'Patrick Brian', 'Initials': 'PB', 'LastName': 'Murphy', 'Affiliation': ""Lane Fox Clinical Respiratory Physiology Research Centre, St Thomas' Hospital, King's Health Partners, London, UK.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hart', 'Affiliation': ""Lane Fox Clinical Respiratory Physiology Research Centre, St Thomas' Hospital, King's Health Partners, London, UK nicholas.hart@gstt.nhs.uk.""}]",The European respiratory journal,['10.1183/13993003.01126-2019']
81,32363616,"The effect of synbiotic supplementation on anthropometric indices, appetite, and constipation in people with hypothyroidism: A randomized, double-blind, placebo-controlled trial.","Hypothyroidism and obesity are two highly prevalent conditions that appear to be closely related. Hypothyroidism is correlated with weight gain, loss of appetite, constipation, and a higher incidence of obesity. The present study aimed to investigate the effects of synbiotic supplementation on anthropometric indices, appetite, and constipation in subjects with hypothyroidism. Sixty subjects with hypothyroidism were assigned into two groups to receive either 500 mg/day of synbiotic (n = 30) or a placebo (n = 30) per day for 8 weeks. Anthropometric indices, appetite, and constipation were assessed at study baseline and end of the trial. At the end of trial, waist-to-hip ratio was significantly decreased in the synbiotic group (p = .030), whereas there were no significant differences between groups. We did not observe any statistically significant change in appetite or other anthropometric indices (p > .05). Compared with the placebo synbiotic supplementation led to a significant reduction in constipation (p = .048). The results of the present trial indicated that synbiotic supplementation may have favorable results in constipation among subjects with hypothyroidism for 8 weeks. Further studies with larger sample size and longer duration are needed to confirm our findings.",2020,Compared with the placebo synbiotic supplementation led to a significant reduction in constipation (p = .048).,"['people with hypothyroidism', 'subjects with hypothyroidism', 'subjects with hypothyroidism for 8\u2009weeks', 'Sixty subjects with hypothyroidism']","['500\u2009mg/day of synbiotic', 'synbiotic supplementation', 'placebo synbiotic supplementation', 'placebo']","['waist-to-hip ratio', 'appetite or other anthropometric indices', 'Anthropometric indices, appetite, and constipation', 'anthropometric indices, appetite, and constipation', 'weight gain, loss of appetite, constipation', 'constipation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}]",60.0,0.458891,Compared with the placebo synbiotic supplementation led to a significant reduction in constipation (p = .048).,"[{'ForeName': 'Sepide', 'Initials': 'S', 'LastName': 'Talebi', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Karimifar', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Heidari', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Food Security Research Center and Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Asbaghi', 'Affiliation': 'Student Research Committee, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Hadi', 'Affiliation': 'Halal Research Center of IRI, FDA, Tehran, Iran.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Marx', 'Affiliation': 'iMPACT, School of Medicine, Deakin University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': 'Food Security Research Center and Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6710']
82,32363636,Task-specific strength increases after lower-limb compound resistance training occurred in the absence of corticospinal changes in vastus lateralis.,"NEW FINDINGS


What is the central question of the study? Are corticospinal responses to acute and short-term squat resistance training task-specific? What is the main finding and its importance? A single bout of resistance training increased spinal excitability, but no changes in corticospinal responses were noted following 4 weeks of squat training despite task-specific increases in strength. The present data suggest that processes along the corticospinal pathway of the knee extensors play a limited role in the task-specific increase in strength following resistance training.
ABSTRACT


Neural adaptations subserving strength increases have been shown to be task-specific, but responses and adaptation to lower-limb compound exercises such as the squat are commonly assessed in a single-limb isometric task. This two-part study assessed neuromuscular responses to an acute bout (Study A) and 4 weeks (Study B) of squat resistance training at 80% of one-repetition-maximum, with measures taken during a task-specific isometric squat (IS) and non-specific isometric knee extension (KE). Eighteen healthy volunteers (25 ± 5 years) were randomised into either a training (n = 10) or a control (n = 8) group. Neural responses were evoked at the intracortical, corticospinal and spinal levels, and muscle thickness was assessed using ultrasound. The results of Study A showed that the acute bout of squat resistance training decreased maximum voluntary contraction (MVC) for up to 45 min post-exercise (-23%, P < 0.001). From 15-45 min post-exercise, spinally evoked responses were increased in both tasks (P = 0.008); however, no other evoked responses were affected (P ≥ 0.240). Study B demonstrated that following short-term resistance training, participants improved their one repetition maximum squat (+35%, P < 0.001), which was reflected by a task-specific increase in IS MVC (+49%, P = 0.001), but not KE (+1%, P = 0.882). However, no training-induced changes were observed in muscle thickness (P = 0.468) or any evoked responses (P = 0.141). Adjustments in spinal motoneuronal excitability are evident after acute resistance training. After a period of short-term training, there were no changes in the responses to central nervous system stimulation, which suggests that alterations in corticospinal properties of the vastus lateralis might not contribute to increases in strength.",2020,"A single bout of resistance training increased spinal excitability, however no changes in corticospinal responses were noted following 4 weeks of squat training despite task-specific increases in strength.",['Eighteen healthy volunteers (25\xa0±\xa05 years'],"['squat resistance training at 80% of 1-repetition-maximum, with measures taken during a task-specific isometric squat (IS) and non-specific isometric knee extension (KE']","['task-specific increase in IS MVC', 'maximum voluntary contraction (MVC', 'spinal excitability', 'corticospinal responses', 'muscle thickness', 'repetition maximum squat']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",18.0,0.0239771,"A single bout of resistance training increased spinal excitability, however no changes in corticospinal responses were noted following 4 weeks of squat training despite task-specific increases in strength.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ansdell', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Callum G', 'Initials': 'CG', 'LastName': 'Brownstein', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Škarabot', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Angius', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Dawson', 'Initials': 'D', 'LastName': 'Kidgell', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Ashlyn', 'Initials': 'A', 'LastName': 'Frazer', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Kirsty M', 'Initials': 'KM', 'LastName': 'Hicks', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rade', 'Initials': 'R', 'LastName': 'Durbaba', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Howatson', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Goodall', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}]",Experimental physiology,['10.1113/EP088629']
83,32363743,Positive association of serum uric acid with new-onset diabetes in Chinese women with hypertension in a retrospective analysis of the China Stroke Primary Prevention Trial.,"AIMS


To investigate the association of baseline serum uric acid (UA) with new-onset diabetes, and to explore the possible effect modifiers in Chinese adults with hypertension.
MATERIALS AND METHODS


A total of 14 943 hypertensive patients with available UA measurements and without diabetes at baseline were included from the China Stroke Primary Prevention Trial (CSPPT). Participants were randomly assigned to a double-blind daily treatment with 10 mg enalapril and 0.8 mg folic acid or 10 mg enalapril alone. The primary outcome was new-onset diabetes, defined as physician-diagnosed diabetes or use of glucose-lowering drugs during follow-up, or fasting glucose ≥7.0 mmol/L at the exit visit.
RESULTS


Over a median follow-up of 4.5 years, 1623 participants (10.9%) developed diabetes. Overall, there was a positive association between baseline UA and new-onset diabetes in women (per SD increment; adjusted odds ratio [OR] 1.14, 95% confidence interval [CI] 1.07, 1.23), but not in men (adjusted OR 1.01, 95% CI 0.92, 1.10). Moreover, a stronger positive association between baseline UA and new-onset diabetes was found among women with lower time-averaged on-treatment systolic blood pressure during the treatment period (<140 vs. ≥140 mmHg; P-interaction = 0.024), higher baseline body mass index (<24 vs. ≥24 kg/m 2  ; P-interaction = 0.012), or higher baseline waist circumference (<80 vs. ≥80 cm; P-interaction = 0.032).
CONCLUSIONS


Our study suggested that higher baseline UA was significantly associated with increased risk of new-onset diabetes in hypertensive Chinese women, but not in men. Further prospective studies are required to validate the differential association by sex.",2020,"<24 vs. ≥24 kg/m 2  ; P-interaction = 0.012), or higher baseline waist circumference (WC) (<80 vs. ≥80 cm; P-interaction = 0.032).
","['participants with different characteristics', 'A total 14\u2009943 hypertensive patients with available UA measurements and without diabetes at baseline were included from the China Stroke Primary Prevention Trial (CSPPT', 'hypertensive Chinese adults', 'hypertensive Chinese females']",['enalapril and 0.8\u2009mg folic acid or 10\u2009mg enalapril alone'],"['risk of new-onset diabetes', 'diabetes', 'new-onset diabetes, defined as physician-diagnosed diabetes or use of glucose-lowering drugs during follow-up, or fasting glucose ≥7.0\u2009mmol/L at the exit visit', 'baseline serum uric acid (UA) and new-onset diabetes', 'baseline UA and new-onset diabetes']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}]",14943.0,0.181051,"<24 vs. ≥24 kg/m 2  ; P-interaction = 0.012), or higher baseline waist circumference (WC) (<80 vs. ≥80 cm; P-interaction = 0.032).
","[{'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Mengyi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhuxian', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Chengzhang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Shenzhen Evergreen Medical Institute, Shenzhen, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiology, Loudi Central Hospital, Loudi, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Lishun', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Shenzhen Evergreen Medical Institute, Shenzhen, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Division of Nephrology, National Clinical Research Centre for Kidney Disease, State Key Laboratory for Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14072']
84,32360256,Multivessel Versus Culprit-Vessel Percutaneous Coronary Intervention in Cardiogenic Shock.,"OBJECTIVES


This study sought to compare outcomes of patients enrolled in the NCSI (National Cardiogenic Shock Initiative) trial who were treated using a revascularization strategy of percutaneous coronary intervention (PCI) of multivessel PCI (MV-PCI) versus culprit-vessel PCI (CV-PCI).
BACKGROUND


In patients with multivessel disease who present with acute myocardial infarction and cardiogenic shock (AMICS), intervening on the nonculprit vessel is controversial. There are conflicting published reports and lack of evidence, particularly in patients treated with early mechanical circulatory support (MCS).
METHODS


From July 2016 to December 2019, patients who presented with AMICS to 57 participating hospitals were included in this analysis. All patients were treated using a standard shock protocol emphasizing early MCS, revascularization, and invasive hemodynamic monitoring. Patients with multivessel coronary artery disease (MVCAD) were analyzed according to whether CV-PCI or MV-PCI was undertaken during the index procedure.
RESULTS


Of 198 patients with MVCAD, 126 underwent MV-PCI (64%) and 72 underwent CV-PCI (36%). Demographics between the cohorts were similar with respect to age, sex, history of diabetes, prior PCI or coronary artery bypass grafting, and prior history of myocardial infarction. Patients who underwent MV-PCI had a trend toward more severe impairment of cardiac output and worse lactate clearance on presentation, and cardiac performance was significantly worse at 12 h. However, 24 h from PCI, the hemometabolic derangements were similar. Survival and rates of acute kidney injury were not significantly different between groups (69.8% MV-PCI vs. 65.3% CV-PCI; p = 0.51; and 29.9% vs. 34.2%; p = 0.64, respectively).
CONCLUSIONS


In patients with MVCAD presenting with AMICS treated with early MCS, revascularization of nonculprit lesions was associated with similar hospital survival and acute kidney injury when compared with culprit-only PCI. Selective nonculprit PCI can be safety performed in AMICS in patients supported with mechanical circulatory support.",2020,"Demographics between the cohorts were similar with respect to age, sex, history of diabetes, prior PCI or coronary artery bypass grafting, and prior history of myocardial infarction.","['patients enrolled in the NCSI (National Cardiogenic Shock Initiative) trial who were treated using a revascularization strategy of', 'patients with MVCAD presenting with AMICS treated with early MCS, revascularization of nonculprit lesions', 'patients supported with mechanical circulatory support', 'Cardiogenic Shock', '198 patients with MVCAD', 'patients with multivessel disease who present with acute myocardial infarction and cardiogenic shock (AMICS', 'Patients with multivessel coronary artery disease (MVCAD', 'patients treated with early mechanical circulatory support (MCS', 'From July 2016 to December 2019, patients who presented with AMICS to 57 participating hospitals']","['Culprit-Vessel Percutaneous\xa0Coronary Intervention', 'percutaneous coronary intervention (PCI) of multivessel PCI (MV-PCI) versus culprit-vessel PCI (CV-PCI', 'Multi']","['Survival and rates of acute kidney injury', 'hospital survival and acute kidney injury', 'severe impairment of cardiac output and worse lactate clearance on presentation, and cardiac performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",198.0,0.0717317,"Demographics between the cohorts were similar with respect to age, sex, history of diabetes, prior PCI or coronary artery bypass grafting, and prior history of myocardial infarction.","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lemor', 'Affiliation': 'Department of Cardiology, Henry Ford Hospital, Detroit, Michigan. Electronic address: alejandrolemor@outlook.com.'}, {'ForeName': 'Mir B', 'Initials': 'MB', 'LastName': 'Basir', 'Affiliation': 'Department of Cardiology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Kirit', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiology, St. Joseph Mercy Oakland, Pontiac, Michigan.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kolski', 'Affiliation': ""Department of Cardiology, St. Joseph's Hospital-Orange, Orange, California.""}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Kaki', 'Affiliation': 'Department of Cardiology, Ascension St. John Hospital-Detroit, Detroit, Michigan.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Kapur', 'Affiliation': 'Department of Cardiology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Riley', 'Affiliation': 'The Christ Hospital Health Network, Cincinnati Ohio.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Finley', 'Affiliation': 'Department of Cardiology, Mercy Fitzgerald Hospital, Yeadon, Pennsylvania.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goldsweig', 'Affiliation': 'Department of Cardiology, University of Nebraska, Omaha, Nebraska.'}, {'ForeName': 'Herbert D', 'Initials': 'HD', 'LastName': 'Aronow', 'Affiliation': 'Department of Cardiology, Alpert Medical School at Brown University, Providence, Rhode Island.'}, {'ForeName': 'P Matthew', 'Initials': 'PM', 'LastName': 'Belford', 'Affiliation': 'Department of Cardiology, Wake Forest Baptist Health, Winston-Salem, North Carolina.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Tehrani', 'Affiliation': 'Department of Cardiology, Inova Fairfax Hospital, Falls Church, Virginia.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Truesdell', 'Affiliation': 'Department of Cardiology, Inova Fairfax Hospital, Falls Church, Virginia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lasorda', 'Affiliation': 'Department of Cardiology, Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bharadwaj', 'Affiliation': 'Department of Cardiology, Loma Linda Medical Center, Loma Linda, California.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Hanson', 'Affiliation': 'Department of Cardiology, Beaumont Hospital-Royal Oak, Royal Oak, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'LaLonde', 'Affiliation': 'Department of Cardiology, Ascension St. John Hospital-Detroit, Detroit, Michigan.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gorgis', 'Affiliation': 'Department of Cardiology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': ""O'Neill"", 'Affiliation': 'Department of Cardiology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.03.012']
85,32353635,Feasibility of decision rule-based treatment of comorbid youth: A pilot randomized control trial.,"This study examined the feasibility, acceptability, and preliminary efficacy of a decision rule driven treatment for youth with comorbid conduct problems and depression. A randomized, controlled, repeated measures design was used to compare two treatment approaches: Decision-Rule Based Treatment (DR) and Sequential Treatment (SEQ). Participants included 30 children (ages 8-14; 66% female; 80% Caucasian) who met criteria for a depressive disorder (major depressive disorder and/or dysthymia) and a conduct problem disorder (oppositional defiant disorder and/or conduct disorder). Assessments were conducted at baseline, post-treatment, and six-month follow-up. Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions. Both treatments showed similar remission of internalizing and externalizing diagnoses. Participants in DR showed significantly greater improvements at six-month follow-up in child-reported depressive symptom severity compared to SEQ. Both DR and SEQ conditions showed significantly lower behavior problems at end of treatment and six-month follow-up. DR showed significant reductions in emotion dysregulation at 6-month follow-up, while SEQ did not. Findings suggest that a decision rule based intervention holds promise as a feasible and acceptable treatment with high rates of remittance.",2020,"Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions.","['Participants included 30 children (ages 8-14; 66% female; 80% Caucasian) who met criteria for a depressive disorder (major depressive disorder and/or dysthymia) and a conduct problem disorder (oppositional defiant disorder and/or conduct disorder', 'youth with comorbid conduct problems and depression', 'comorbid youth']",['Decision-Rule Based Treatment (DR) and Sequential Treatment (SEQ'],"['remission of internalizing and externalizing diagnoses', 'behavior problems', 'depressive symptom severity', 'emotion dysregulation']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0149654', 'cui_str': 'Conduct disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",30.0,0.0310239,"Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions.","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Wolff', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA; Rhode Island Hospital, Providence, RI, USA. Electronic address: jennifer_wolff@brown.edu.'}, {'ForeName': 'Abbe', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA; Rhode Island Hospital, Providence, RI, USA.'}, {'ForeName': 'Lourah M', 'Initials': 'LM', 'LastName': 'Kelly', 'Affiliation': 'Rhode Island Hospital, Providence, RI, USA; University of Connecticut Health Center, Farmington, CT, USA.'}, {'ForeName': 'Elisabeth A', 'Initials': 'EA', 'LastName': 'Frazier', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103625']
86,32354987,"Renal, Cardiovascular, and Safety Outcomes of Canagliflozin by Baseline Kidney Function: A Secondary Analysis of the CREDENCE Randomized Trial.","BACKGROUND


Canagliflozin reduced renal and cardiovascular events in people with type 2 diabetes in the CREDENCE trial. We assessed efficacy and safety of canagliflozin by initial estimated glomerular filtration rate (eGFR).
METHODS


CREDENCE randomly assigned 4401 participants with an eGFR of 30 to <90 ml/min per 1.73 m 2  and substantial albuminuria to canagliflozin 100 mg or placebo. We used Cox proportional hazards regression to analyze effects on renal and cardiovascular efficacy and safety outcomes within screening eGFR subgroups (30 to <45, 45 to <60, and 60 to <90 ml/min per 1.73 m 2 ) and linear mixed effects models to analyze the effects on eGFR slope.
RESULTS


At screening, 1313 (30%), 1279 (29%), and 1809 (41%) participants had an eGFR of 30 to <45, 45 to <60, and 60 to <90 ml/min per 1.73 m 2 , respectively. The relative benefits of canagliflozin for renal and cardiovascular outcomes appeared consistent among eGFR subgroups (all  P  interaction >0.11). Subgroups with lower eGFRs, who were at greater risk, exhibited larger absolute benefits for renal outcomes. Canagliflozin's lack of effect on serious adverse events, amputations, and fractures appeared consistent among eGFR subgroups. In all subgroups, canagliflozin use led to an acute eGFR drop followed by relative stabilization of eGFR loss. Among those with an eGFR of 30 to <45 ml/min per 1.73 m 2 , canagliflozin led to an initial drop of 2.03 ml/min per 1.73 m 2 . Thereafter, decline in eGFR was slower in the canagliflozin versus placebo group (-1.72 versus -4.33 ml/min per 1.73 m 2 ; between-group difference 2.61 ml/min per 1.73 m 2 ).
CONCLUSIONS


Canagliflozin safely reduced the risk of renal and cardiovascular events, with consistent results across eGFR subgroups, including the subgroup initiating treatment with an eGFR of 30 to <45 ml/min per 1.73 m 2 . Absolute benefits for renal outcomes were greatest in subgroups with lower eGFR.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy (CREDENCE), NCT02065791.",2020,The relative benefits of canagliflozin for renal and cardiovascular outcomes appeared consistent among eGFR subgroups (all  P  interaction >0.11).,"['people with type 2 diabetes', 'Participants With Diabetic Nephropathy', 'randomly assigned 4401 participants with an eGFR of 30 to <90 ml/min per 1.73 m 2  and substantial albuminuria to']","['Canagliflozin', 'canagliflozin 100 mg or placebo', 'canagliflozin', 'placebo']","['glomerular filtration rate (eGFR', 'renal and cardiovascular events', 'decline in eGFR', 'risk of renal and cardiovascular events', 'Renal, Cardiovascular, and Safety Outcomes of Canagliflozin by Baseline Kidney Function', 'renal and cardiovascular efficacy and safety outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C3556569', 'cui_str': 'canagliflozin 100 MG [Invokana]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",4401.0,0.19396,The relative benefits of canagliflozin for renal and cardiovascular outcomes appeared consistent among eGFR subgroups (all  P  interaction >0.11).,"[{'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia mjardine@georgeinstitute.org.au.'}, {'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Department of Medicine, Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Oshima', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Indiana University School of Medicine and Veterans Affairs Medical Center, Indianapolis, Indiana.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Bajaj', 'Affiliation': 'LMC Healthcare, Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Bull', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Charytan', 'Affiliation': 'Baim Institute for Clinical Research, Boston, Massachusetts.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'Di Tanna', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Division of Biostatistics, Department of Population Health Sciences, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Adeera', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': 'Division of Nephrology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute of Medical Research, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Qiu', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Renal Division, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Rosenthal', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019111168']
87,32367748,Clinical efficacy of Baihe Gujin decoction combined with anti-tuberculosis therapy for pulmonary tuberculosis with Yin-deficiency and Fire-hyperactivity syndrome.,"OBJECTIVE


To evaluate the clinical efficacy of Baihe Gujin decoction combined with anti-tuberculosis therapy in mitigating the symptoms of pulmonary tuberculosis and to measure the effect on the CD4+ CD25+ regulatory T cell (T reg ) ratio.
METHODS


This randomized study enrolled patients with pulmonary tuberculosis and randomly assigned them to one of two treatment groups: an anti-tuberculosis treatment group and a combined treatment group. Bronchoalveolar lavage was performed before and 2 weeks after treatment. The ratio of CD4+ CD25+ T reg  cells and the levels of tumour necrosis factor (TNF)-α, interleukin (IL)-4, IL-6 and IL-12 in peripheral blood and bronchoalveolar lavage fluid were measured. Symptoms were recorded before and after treatment.
RESULTS


A total of 100 patients were enrolled and assigned to the anti-tuberculosis ( n  = 58) and combined treatment groups ( n  = 42). In the combined treatment group, Leicester Cough Questionnaire score, erythrocyte sedimentation rate, CD4+ CD25+ T reg  cell ratio in bronchoalveolar lavage fluid, cytokine levels, chest pain score and sleep disorder score were significantly decreased compared with the anti-tuberculosis treatment group after treatment. The leukocyte count, haemoglobin level, platelet and alanine aminotransferase levels did not differ significantly between the two groups after treatment. The creatinine level in the combined treatment group was significantly lower than that in the anti-tuberculosis treatment group.
CONCLUSION


Baihe Gujin decoction combined with anti-tuberculosis treatment can effectively alleviate the symptoms of pulmonary tuberculosis, enhance the host immune function and protect renal function.",2020,"The leukocyte count, haemoglobin level, platelet and alanine aminotransferase levels did not differ significantly between the two groups after treatment.","['pulmonary tuberculosis with Yin-deficiency and Fire-hyperactivity syndrome', 'enrolled patients with pulmonary tuberculosis', '100 patients were enrolled and assigned to the anti-tuberculosis ( n \u2009=\u200958) and combined treatment groups ( n \u2009=\u200942']","['anti-tuberculosis treatment group and a combined treatment group', 'Baihe Gujin decoction combined with anti-tuberculosis therapy', 'Baihe Gujin decoction combined with anti-tuberculosis treatment']","['CD4+ CD25+ regulatory T cell (T reg ) ratio', 'ratio of CD4+ CD25+ T reg  cells and the levels of tumour necrosis factor (TNF)-α, interleukin (IL)-4, IL-6 and IL-12 in peripheral blood and bronchoalveolar lavage fluid', 'leukocyte count, haemoglobin level, platelet and alanine aminotransferase levels', 'Leicester Cough Questionnaire score, erythrocyte sedimentation rate, CD4+ CD25+ T reg  cell ratio in bronchoalveolar lavage fluid, cytokine levels, chest pain score and sleep disorder score', 'creatinine level']","[{'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0085257', 'cui_str': 'Yin deficiency'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0007507', 'cui_str': 'Lymphocyte antigen CD25'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0006279', 'cui_str': 'Bronchoalveolar lavage fluid sample'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}]",100.0,0.0684112,"The leukocyte count, haemoglobin level, platelet and alanine aminotransferase levels did not differ significantly between the two groups after treatment.","[{'ForeName': 'Hai-Bo', 'Initials': 'HB', 'LastName': 'Ge', 'Affiliation': 'Department of Respiratory Medicine, The Third Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Respiratory Medicine, The Third Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China.'}]",The Journal of international medical research,['10.1177/0300060519875535']
88,32369007,Computerised speech and language therapy or attention control added to usual care for people with long-term post-stroke aphasia: the Big CACTUS three-arm RCT.,"BACKGROUND


People with aphasia may improve their communication with speech and language therapy many months/years after stroke. However, NHS speech and language therapy reduces in availability over time post stroke.
OBJECTIVE


This trial evaluated the clinical effectiveness and cost-effectiveness of self-managed computerised speech and language therapy to provide additional therapy.
DESIGN


A pragmatic, superiority, single-blind, parallel-group, individually randomised (stratified block randomisation, stratified by word-finding severity and site) adjunct trial.
SETTING


Twenty-one UK NHS speech and language therapy departments.
PARTICIPANTS


People with post-stroke aphasia (diagnosed by a speech and language therapist) with long-standing (> 4 months) word-finding difficulties.
INTERVENTIONS


The groups were (1) usual care; (2) daily self-managed computerised word-finding therapy tailored by speech and language therapists and supported by volunteers/speech and language therapy assistants for 6 months plus usual care (computerised speech and language therapy); and (3) activity/attention control (completion of puzzles and receipt of telephone calls from a researcher for 6 months) plus usual care.
MAIN OUTCOME MEASURES


Co-primary outcomes - change in ability to find treated words of personal relevance in a bespoke naming test (impairment) and change in functional communication in conversation rated on the activity scale of the Therapy Outcome Measures (activity) 6 months after randomisation. A key secondary outcome was participant-rated perception of communication and quality of life using the Communication Outcomes After Stroke questionnaire at 6 months. Outcomes were assessed by speech and language therapists using standardised procedures. Cost-effectiveness was estimated using treatment costs and an accessible EuroQol-5 Dimensions, five-level version, measuring quality-adjusted life-years.
RESULTS


A total of 818 patients were assessed for eligibility and 278 participants were randomised between October 2014 and August 2016. A total of 240 participants (86 usual care, 83 computerised speech and language therapy, 71 attention control) contributed to modified intention-to-treat analysis at 6 months. The mean improvements in word-finding were 1.1% (standard deviation 11.2%) for usual care, 16.4% (standard deviation 15.3%) for computerised speech and language therapy and 2.4% (standard deviation 8.8%) for attention control. Computerised speech and language therapy improved word-finding 16.2% more than usual care did (95% confidence interval 12.7% to 19.6%;  p  < 0.0001) and 14.4% more than attention control did (95% confidence interval 10.8% to 18.1%). Most of this effect was maintained at 12 months ( n  = 219); the mean differences in change in word-finding score were 12.7% (95% confidence interval 8.7% to 16.7%) higher in the computerised speech and language therapy group ( n  = 74) than in the usual-care group ( n  = 84) and 9.3% (95% confidence interval 4.8% to 13.7%) higher in the computerised speech and language therapy group than in the attention control group ( n  = 61). Computerised speech and language therapy did not show significant improvements on the Therapy Outcome Measures or Communication Outcomes After Stroke scale compared with usual care or attention control. Primary cost-effectiveness analysis estimated an incremental cost per participant of £732.73 (95% credible interval £674.23 to £798.05). The incremental quality-adjusted life-year gain was 0.017 for computerised speech and language therapy compared with usual care, but its direction was uncertain (95% credible interval -0.05 to 0.10), resulting in an incremental cost-effectiveness ratio of £42,686 per quality-adjusted life-year gained. For mild and moderate word-finding difficulty subgroups, incremental cost-effectiveness ratios were £22,371 and £28,898 per quality-adjusted life-year gained, respectively, for computerised speech and language therapy compared with usual care.
LIMITATIONS


This trial excluded non-English-language speakers, the accessible EuroQol-5 Dimensions, five-level version, was not validated and the measurement of attention control fidelity was limited.
CONCLUSIONS


Computerised speech and language therapy enabled additional self-managed speech and language therapy, contributing to significant improvement in finding personally relevant words (as specifically targeted by computerised speech and language therapy) long term post stroke. Gains did not lead to improvements in conversation or quality of life. Cost-effectiveness is uncertain owing to uncertainty around the quality-adjusted life-year gain, but computerised speech and language therapy may be more cost-effective for participants with mild and moderate word-finding difficulties. Exploring ways of helping people with aphasia to use new words in functional communication contexts is a priority.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN68798818.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 19. See the NIHR Journals Library website for further project information. The Tavistock Trust for Aphasia provided additional support to enable people in the control groups to experience the intervention after the trial had ended.",2020,Computerised speech and language therapy did not show significant improvements on the Therapy Outcome Measures or Communication Outcomes After Stroke scale compared with usual care or attention control.,"['Twenty-one UK NHS speech and language therapy departments', '240 participants (86 usual care, 83 computerised speech and language therapy, 71 attention control) contributed to modified intention-to-treat analysis at 6 months', 'participants with mild and moderate word-finding difficulties', 'A total of 818 patients were assessed for eligibility and 278 participants were randomised between October 2014 and August 2016', 'People with post-stroke aphasia (diagnosed by a speech and language therapist) with long-standing (>\u20094 months) word-finding difficulties']","['usual care; (2) daily self-managed computerised word-finding therapy tailored by speech and language therapists and supported by volunteers/speech and language therapy assistants for 6 months plus usual care (computerised speech and language therapy); and (3) activity/attention control (completion of puzzles and receipt of telephone calls from a researcher for 6 months) plus usual care', 'Computerised speech and language therapy', 'Computerised speech and language therapy enabled additional self-managed speech and language therapy', 'Computerised speech and language therapy or attention control added to usual care for people with long-term post-stroke aphasia', 'self-managed computerised speech and language therapy']","['Cost-effectiveness', 'participant-rated perception of communication and quality of life using the Communication Outcomes', 'mean improvements in word-finding', 'Computerised speech and language therapy', 'change in word-finding score', 'incremental cost-effectiveness ratios', 'incremental quality-adjusted life-year gain', 'conversation or quality of life']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0037831', 'cui_str': 'Speech therapy'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0454643', 'cui_str': 'Word finding difficulty'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0402015', 'cui_str': 'Speech and language therapist'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0402015', 'cui_str': 'Speech and language therapist'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0037831', 'cui_str': 'Speech therapy'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0423995', 'cui_str': 'Puzzled'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0037831', 'cui_str': 'Speech therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",818.0,0.114582,Computerised speech and language therapy did not show significant improvements on the Therapy Outcome Measures or Communication Outcomes After Stroke scale compared with usual care or attention control.,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Palmer', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Munyaradzi', 'Initials': 'M', 'LastName': 'Dimairo', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Latimer', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cross', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Brady', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Enderby', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Bowen', 'Affiliation': 'Division of Neuroscience & Experimental Psychology, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Julious', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Harrison', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Abualbishr', 'Initials': 'A', 'LastName': 'Alshreef', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Bradley', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Bhadhuri', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chater', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hughes', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Witts', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Herbert', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24190']
89,32366156,"Triple fixed-dose combination empagliflozin, linagliptin, and metformin for patients with type 2 diabetes.","Objectives : Fixed-dose combination (FDC) therapy can improve outcomes in type 2 diabetes (T2D). We evaluated the bioequivalence of 2 doses of an FDC of extended-release metformin (metformin XR), empagliflozin, a sodium-glucose co-transporter 2 inhibitor, and linagliptin, a dipeptidyl peptidase-4 inhibitor, versus corresponding free tablet combinations. Methods : Two randomized, open-label, two-way crossover studies in healthy adults compared: 2 FDC tablets of empagliflozin 5 mg/linagliptin 2.5 mg/metformin XR 1000 mg (Study 1; N = 30), 1 FDC tablet of empagliflozin 25 mg/linagliptin 5 mg/metformin XR 1000 mg (Study 2; N = 30) versus corresponding dose of free combinations. Subjects received study medication under fed conditions; washout was ≥35 days between treatments. Primary endpoints: area under the plasma concentration-time curve (AUC) from time 0 to last quantifiable data point for empagliflozin and metformin; AUC from time 0 to 72 hours for linagliptin, and peak plasma concentration (C max ) for empagliflozin, linagliptin, and metformin. Bioequivalence was defined as adjusted geometric mean ratios (FDC: free combination) and two-sided 90% confidence intervals (CIs) of AUC and C max  for each component within 80.00-125.00%. Results : Study 1: 27/29 and 28/30 treated participants were included in the pharmacokinetic analysis for the FDC and free combination periods, respectively. Study 2: 29/29 treated participants were included in the pharmacokinetic analysis for both periods. The adjusted geometric mean ratios of FDCs to their respective free tablet combinations and two-sided 90% CIs were all within the predefined range. The shapes of the mean plasma concentration-time profile of empagliflozin, linagliptin, and metformin XR were similar for subjects in the FDC and free combination groups in both studies. No serious adverse events were reported. Conclusion : The evaluated doses of empagliflozin/linagliptin/metformin XR FDC tablets were bioequivalent to the corresponding free combinations. Based on these two bioequivalence studies and existing phase 3 data, the FDA has recently approved this triple FDC to improve glycemic control in adults with T2D.",2020,The evaluated doses of empagliflozin/linagliptin/metformin XR FDC tablets were bioequivalent to the corresponding free combinations.,"['healthy adults compared: 2', 'adults with T2D', 'Study 1: 27/29 and 28/30 treated participants were included in the pharmacokinetic analysis for the FDC and free combination periods, respectively', 'patients with type 2 diabetes']","['empagliflozin/linagliptin/metformin XR FDC tablets', 'empagliflozin, linagliptin, and metformin', 'Triple fixed-dose combination empagliflozin, linagliptin, and metformin', 'FDC of extended-release metformin (metformin XR), empagliflozin, a sodium-glucose co-transporter 2 inhibitor, and linagliptin, a dipeptidyl peptidase-4 inhibitor', 'FDC tablets of empagliflozin 5 mg/linagliptin 2.5 mg/metformin XR', 'FDC) therapy', 'FDC tablet of empagliflozin 25 mg/linagliptin 5 mg/metformin XR']","['area under the plasma concentration-time curve (AUC) from time 0 to last quantifiable data point for empagliflozin and metformin; AUC from time 0 to 72\xa0hours for linagliptin, and peak plasma concentration (C max ', 'adjusted geometric mean ratios of FDCs', 'mean plasma concentration-time profile of empagliflozin, linagliptin, and metformin XR', 'serious adverse events']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3871442', 'cui_str': 'linagliptin and empagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C4050744', 'cui_str': 'empagliflozin 5 MG'}, {'cui': 'C3265893', 'cui_str': 'Linagliptin 2.5 MG'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3883488', 'cui_str': 'empagliflozin 25 MG / Linagliptin 5 MG [Glyxambi]'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0607173,The evaluated doses of empagliflozin/linagliptin/metformin XR FDC tablets were bioequivalent to the corresponding free combinations.,"[{'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine/Endocrinology and Department of Population and Data Sciences, UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Beetz', 'Affiliation': 'Global Clinical Operations, Early Trials, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Sennewald', 'Affiliation': 'Global Clinical Operations, Early Trials, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Schuler-Metz', 'Affiliation': 'Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bertulis', 'Affiliation': 'Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Loley', 'Affiliation': 'Biostatistics and Data Sciences, Clinical Statistics, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lang', 'Affiliation': 'Biostatistics and Data Sciences, Clinical Statistics, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lippert', 'Affiliation': 'Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.'}, {'ForeName': 'Jisoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Clinical Development & Cardiometabolism and Respiratory Medicine, Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Linda Shapiro', 'Initials': 'LS', 'LastName': 'Manning', 'Affiliation': 'Clinical Development & Medical Affairs - Cardiometabolism, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Terada', 'Affiliation': 'Clinical Development & Medical Affairs - Cardiometabolism, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1750228']
90,32366163,Gut Microbiota-Dependent Trimethylamine N-oxide and Cardiovascular Outcomes in Patients With Prior Myocardial Infarction: A Nested Case Control Study From the PEGASUS-TIMI 54 Trial.,"Background Trimethylamine N-oxide (TMAO) may have prothrombotic properties. We examined the association of TMAO quartiles with major adverse cardiovascular events (MACE) and the effect of TMAO on the efficacy of ticagrelor. Methods and Results PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin - Thrombolysis in Myocardial Infarction 54) randomized patients with prior myocardial infarction to ticagrelor or placebo (median follow-up 33 months). Baseline plasma concentrations of TMAO were measured in a nested case-control study of 597 cases with cardiovascular death, myocardial infarction, or stroke (MACE) and 1206 controls matched for age, sex, and estimated glomerular filtration rate [eGFR]. Odds ratios (OR) were used for the association between TMAO quartiles and MACE, adjusting for baseline clinical characteristics (age, sex, eGFR, region, body mass index, hypertension, hypercholesterolemia, diabetes mellitus, smoking, peripheral artery disease, index event, aspirin dosage and treatment arm), and cardiovascular biomarkers (hs-TnT [high-sensitivity troponin T], hs-CRP [high-sensitivity C-reactive protein], NT-proBNP [N-terminal-pro-B-type natriuretic peptide]). Higher TMAO quartiles were associated with risk of MACE (OR for quartile 4 versus quartile 1, 1.43, 95% CI, 1.06-1.93,  P  trend=0.015). The association was driven by cardiovascular death (OR 2.25, 95% CI, 1.28-3.96,  P  trend=0.003) and stroke (OR 2.68, 95% CI, 1.39-5.17,  P  trend<0.001). After adjustment for clinical factors, the association persisted for cardiovascular death (OR adj  1.89, 95% CI, 1.03-3.45,  P  trend=0.027) and stroke (OR adj  2.01, 95% CI, 1.01-4.01,  P  trend=0.022), but was slightly attenuated after adjustment for cardiovascular biomarkers (cardiovascular death: OR adj  1.74, 95% CI, 0.88-3.45,  P  trend=0.079; and stroke: OR adj  1.82, 95% CI, 0.88-3.78,  P  trend=0.056). The reduction in MACE with ticagrelor was consistent across TMAO quartiles ( P  interaction=0.92). Conclusions Among patients with prior myocardial infarction, higher TMAO levels were associated with cardiovascular death and stroke but not with recurrent myocardial infarction. The efficacy of ticagrelor was consistent regardless of TMAO levels. Registration URL: https://www.clini​caltr​ials.gov; Unique identifiers: PEGASUS-TIMI 54, NCT01225562.",2020,"Higher TMAO quartiles were associated with risk of MACE (OR for quartile 4 versus quartile 1, 1.43, 95% CI, 1.06-1.93,  P  trend=0.015).","['Myocardial Infarction 54) randomized patients with prior myocardial infarction to', 'Patients With Prior Heart Attack Using', 'Patients', 'patients with prior myocardial infarction', 'With Prior Myocardial Infarction', '597 cases with cardiovascular death, myocardial infarction, or stroke (MACE) and 1206 controls matched for age, sex, and estimated glomerular filtration rate [eGFR']","['Ticagrelor', 'Placebo', ' Trimethylamine N-oxide (TMAO', 'ticagrelor or placebo', 'TMAO', 'Aspirin - Thrombolysis', 'ticagrelor']","['Baseline plasma concentrations of TMAO', 'cardiovascular death and stroke', 'Odds ratios (OR', 'cardiovascular death', 'Gut Microbiota-Dependent Trimethylamine N-oxide and Cardiovascular Outcomes', 'stroke', 'TMAO levels', 'Higher TMAO quartiles', 'TMAO quartiles with major adverse cardiovascular events (MACE']","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",597.0,0.189664,"Higher TMAO quartiles were associated with risk of MACE (OR for quartile 4 versus quartile 1, 1.43, 95% CI, 1.06-1.93,  P  trend=0.015).","[{'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Gencer', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Xinmin S', 'Initials': 'XS', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'CPC Clinical Research Division of Cardiovascular Medicine University of Colorado Denver CO.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Newark Beth Israel Medical Center Rutgers-New Jersey Medical School Newark NJ.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Hôpital Bichat Paris France.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Cardiovascular Research Unit Department of Infection, Immunity and Cardiovascular Disease University of Sheffield United Kingdom.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca Göteborg Sweden.'}, {'ForeName': 'Zeneng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Stanley L', 'Initials': 'SL', 'LastName': 'Hazen', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.015331']
91,32363948,"The safety of medications used to treat peripheral neuropathic pain, part 1 (antidepressants and antiepileptics): review of double-blind, placebo-controlled, randomized clinical trials.","INTRODUCTION


Peripheral neuropathic pain is a highly disabling condition for patients and a challenge for neurologists and pain physicians. Although many drugs have been assessed in scientific studies, few have demonstrated a clear clinical efficacy against neuropathic pain. Moreover, the paucity of data regarding their safety raised the question on the benefit-risk ratio when used in patients experiencing peripheral neuropathies.
AREAS COVERED


The authors conducted a review of double-blind, placebo-controlled, randomized clinical trials to assess the safety of medications used to treat neuropathic pain. This first review was focused on antidepressant and antiepileptic medications. The aim was to provide an overview of the treatment-emergent adverse events (≥10%) and the serious adverse effects described in clinical trials.
EXPERT OPINION


Among antiepileptics and antidepressants, duloxetine appeared to have the most detailed safety for the treatment of peripheral neuropathic pain. Over all studies, the most commonly reported adverse effects were dizziness, drowsiness, nausea, and constipation. Only 20.0% of the included studies (N = 90) presented a good description of adverse effects that included a statistical comparison  vers   us a placebo group. Important methodological improvements must be made to improve the assessment of medication safety in future clinical trials.",2020,"Over all studies, the most commonly reported adverse effects were dizziness, drowsiness, nausea, and constipation.","['patients and a challenge for neurologists and pain physicians', 'patients experiencing peripheral neuropathies']","['duloxetine', 'placebo']","['adverse effects', 'dizziness, drowsiness, nausea, and constipation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237426', 'cui_str': 'Neurologist'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",,0.468693,"Over all studies, the most commonly reported adverse effects were dizziness, drowsiness, nausea, and constipation.","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Selvy', 'Affiliation': 'Université Clermont Auvergne, CHU Clermont-Ferrand, Service de chirurgie digestive, INSERM, NEURO-DOL , Clermont-Ferrand, France.'}, {'ForeName': 'Mélissa', 'Initials': 'M', 'LastName': 'Cuménal', 'Affiliation': 'Université Clermont Auvergne, INSERM NEURO-DOL , Clermont-Ferrand, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Kerckhove', 'Affiliation': 'Université Clermont Auvergne, CHU Clermont-Ferrand, Service de pharmacologie médicale, INSERMNEURO-DOL, Institut Analgesia , Clermont-Ferrand, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Courteix', 'Affiliation': 'Université Clermont Auvergne, INSERM NEURO-DOL , Clermont-Ferrand, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Busserolles', 'Affiliation': 'Université Clermont Auvergne, INSERM NEURO-DOL , Clermont-Ferrand, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Balayssac', 'Affiliation': ""Université Clermont Auvergne, CHU Clermont-Ferrand, Délégation à la recherche clinique et à l'innovation, INSERM, NEURO-DOL , Clermont-Ferrand, France.""}]",Expert opinion on drug safety,['10.1080/14740338.2020.1764934']
92,32374527,A Secondary Data Analysis Examining Young Adults' Performance in an Internet Weight Loss Program with Financial Incentives.,"OBJECTIVE


In traditional behavioral weight loss (BWL) programs, young adults fare worse than older adults with respect to engagement, retention, and weight loss, but money and use of technology have been cited as program factors that might improve outcomes for this population. This study evaluated young adult performance in internet-based BWL (IBWL) offering financial incentives for self-monitoring and weight loss.
METHODS


Participants (N = 180; BMI = 33.2 ± 6.0 kg/m 2  ) were randomly assigned to a 12-week IBWL or IBWL + incentives (IBWL + $) group. This secondary data analysis compared young adults (ages 18-35) in IBWL (n = 16) with young adults in IBWL + $ (n = 12) on percent weight loss, engagement, and retention. Young adults (n = 28) were also compared with older adults (ages 36-70; n = 152) on these outcomes.
RESULTS


Young adult weight loss was -2.8% ± 5.2% in IBWL and -5.4% ± 5.7% in IBWL + $ (P = 0.23, partial η 2   = 0.06). A greater proportion of young adults in IBWL + $ achieved a 10% weight loss compared with IBWL (42% vs. 6%, P = 0.02). Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
CONCLUSIONS


Findings suggest that technology-based BWL has the potential to eliminate weight loss disparities observed between young adults and older adults in in-person BWL trials. Moreover, adding financial incentives holds promise for promoting clinically meaningful weight loss for young adults.",2020,"Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
","['young adults', 'Participants (N\u2009=\u2009180; BMI\u2009=\u200933.2\u2009±\u20096.0 kg/m 2  ', 'young adults and older adults', 'young adults fare worse than older adults', 'Young adults (n\u2009=\u200928) were also compared with older adults (ages 36-70; n\u2009=\u2009152) on these outcomes', 'young adults (ages 18-35) in IBWL (n\u2009=\u200916) with young adults in IBWL\u2009+\u2009$ (n\u2009=\u200912) on percent weight loss, engagement, and retention']","['technology-based BWL', 'IBWL or IBWL\u2009+\u2009incentives (IBWL\u2009+\u2009$) group', 'traditional behavioral weight loss (BWL) programs']","['weight loss', 'retention or weight loss']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.0386472,"Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
","[{'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Tricia M', 'Initials': 'TM', 'LastName': 'Leahey', 'Affiliation': 'Department of Allied Health Services, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Lanoye', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Reading', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Weight Control and Diabetes Research Center, Miriam Hospital, Providence, Rhode Island, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22797']
93,32372294,Pharmacokinetics of Ambroxol Sustained Release (Mucosolvan ®  Retard) Compared with Other Formulations in Healthy Volunteers.,"INTRODUCTION


Ambroxol is used in the treatment of acute and chronic respiratory conditions characterized by abnormal mucus secretion and impaired mucus transport and is available in a variety of formulations. This study aimed to compare the steady-state (SS) pharmacokinetic characteristics of extended-release (ER) 75-mg retard capsules with two immediate-release (IR) formulations (60-mg effervescent tablets and 30-mg tablets) over a 24-h period.
METHODS


An open-label, randomized, three-period, six-sequence crossover study was conducted in healthy volunteers aged 18-45 years who had a normal body mass index. The test (ER 75-mg retard capsule once daily) and reference treatments (half of IR 60-mg effervescent tablet twice daily or 30-mg IR tablet twice daily) were administered on days 1-5 of each treatment period. Meals were standardized and concomitant therapy was prohibited. Blood samples for pharmacokinetic assessment were collected on day 5 (SS) of each treatment period. The co-primary endpoints were exposure (AUC SS 0-24 ) and maximum plasma level (C max SS ).
RESULTS


Twenty-four participants received ambroxol (male n = 13, 54.2%; mean ± standard deviation [SD] age 25.0 ± 6.4 years) and 23 completed the study. ER retard capsules provided similar AUC SS 0-24  compared to IR tablets (geometric means ratio [GMR] 110.7%; 90% confidence interval [CI] 99.8%, 122.7%) and effervescent tablets (GMR 106.9%; 90% CI 100.3%, 114.0%). ER retard capsules provided similar C max SS  compared to IR tablets (GMR 84.7%, 90% CI 77.0%, 93.3%), and lower C max SS  compared to effervescent tablets (GMR 80.9%, 90% CI 73.9%, 88.6%). Time to C max SS  (t max SS ) was longer with ER retard capsules (6.0 h) than with IR tablets (2.0 h) or effervescent tablets (1.0 h).
CONCLUSIONS


ER ambroxol 75-mg retard capsules given once daily showed a similar pharmacokinetic profile to IR ambroxol formulations and therefore can be used instead of these in the treatment of respiratory conditions. CLINICALTRIALS.
GOV IDENTIFIER


NCT02036775.",2020,"ER retard capsules provided similar C max SS  compared to IR tablets (GMR 84.7%, 90% CI 77.0%, 93.3%), and lower C max SS  compared to effervescent tablets (GMR 80.9%, 90% CI 73.9%, 88.6%).","['Healthy Volunteers', 'Twenty-four participants received ambroxol (male n\u2009=\u200913, 54.2%; mean\u2009±\u2009standard deviation [SD] age 25.0\u2009±\u20096.4\xa0years) and 23 completed the study', 'healthy volunteers aged 18-45\xa0years who had a normal body mass index']","['Ambroxol', 'Ambroxol Sustained Release (Mucosolvan ®  Retard', 'extended-release (ER) 75-mg retard capsules with two immediate-release (IR) formulations']","['exposure (AUC SS 0-24 ) and maximum plasma level (C max SS ', 'steady-state (SS) pharmacokinetic characteristics', 'Time to C max']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0002421', 'cui_str': 'Ambroxol'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517808', 'cui_str': '54.2'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231253', 'cui_str': 'Normal body mass index'}]","[{'cui': 'C0002421', 'cui_str': 'Ambroxol'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0023091', 'cui_str': 'Surbronc'}, {'cui': 'C0521111', 'cui_str': 'Retarded'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0673296,"ER retard capsules provided similar C max SS  compared to IR tablets (GMR 84.7%, 90% CI 77.0%, 93.3%), and lower C max SS  compared to effervescent tablets (GMR 80.9%, 90% CI 73.9%, 88.6%).","[{'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Ollier', 'Affiliation': 'PKDM-TMED Department, Sanofi-Aventis, PK-Biopharm, Montpellier, France.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Sent', 'Affiliation': 'Sanofi-Aventis, CHC Medical Affairs, Frankfurt am Main, Germany. ulrike.sent@sanofi.com.'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Mesquita', 'Affiliation': 'Sanofi-Aventis, CHC Medical Affairs, Frankfurt am Main, Germany.'}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Michel', 'Affiliation': 'Department of Pharmacology, Johannes Gutenberg Universität, Mainz, Germany.'}]",Pulmonary therapy,['10.1007/s41030-020-00116-7']
94,32372330,"Dose-dependent effects of netarsudil, a Rho-kinase inhibitor, on the distal outflow tract.","PURPOSE


To characterize the effects of netarsudil on the aqueous humor outflow tract distal to the trabecular meshwork (TM). We hypothesized that netarsudil increases outflow facility in eyes with and without circumferential ab interno trabeculectomy (AIT) that removes the TM.
METHODS


Sixty-four porcine anterior segment cultures were randomly assigned to groups with (n = 32) and without circumferential AIT (n = 32). Cultures were exposed to 0.1, 1, and 10 μM netarsudil (N = 8 eyes per concentration). For each concentration, IOP and vessel diameters were compared with their respective pretreatment baselines. Outflow tract vessel diameters were assessed by spectral-domain optical coherence tomography (SDOCT) and rendered in 4D (XYZ time series).
RESULTS


Netarsudil at 1 μM reduced IOP both in eyes with TM (- 0.60 ± 0.24 mmHg, p = 0.01) and in eyes without TM (- 1.79 ± 0.42 mmHg, p < 0.01). At this concentration, vessels of the distal outflow tract dilated by 72%. However, at 0.1 μM netarsudil elevated IOP in eyes with TM (1.59 ± 0.36 mmHg, p < 0.001) as well as in eyes without TM (0.23 ± 0.32 mmHg, p < 0.001). Vessels of the distal outflow tract constricted by 31%. Similarly, netarsudil at a concentration of 10 μM elevated IOP both in eyes with TM (1.91 ± 0.193, p < 0.001) and in eyes without TM (3.65 ± 0.86 mmHg, p < 0.001). At this concentration, outflow tract vessels constricted by 27%.
CONCLUSION


In the porcine anterior segment culture, the dose-dependent IOP changes caused by netarsudil matched the diameter changes of distal outflow tract vessels. Hyper- and hypotensive properties of netarsudil persisted after TM removal.",2020,"In the porcine anterior segment culture, the dose-dependent IOP changes caused by netarsudil matched the diameter changes of distal outflow tract vessels.",['Sixty-four porcine anterior segment cultures'],['circumferential ab interno trabeculectomy (AIT'],"['Outflow tract vessel diameters', 'IOP', 'concentration, IOP and vessel diameters']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",64.0,0.0358014,"In the porcine anterior segment culture, the dose-dependent IOP changes caused by netarsudil matched the diameter changes of distal outflow tract vessels.","[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, University of Würzburg, Josef-Schneider-Straße 11, 97080, Würzburg, Germany.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Waxman', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Atta', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Ralitsa', 'Initials': 'R', 'LastName': 'Loewen', 'Affiliation': 'Department of Ophthalmology, University of Würzburg, Josef-Schneider-Straße 11, 97080, Würzburg, Germany.'}, {'ForeName': 'Nils A', 'Initials': 'NA', 'LastName': 'Loewen', 'Affiliation': 'Department of Ophthalmology, University of Würzburg, Josef-Schneider-Straße 11, 97080, Würzburg, Germany. loewen.nils@gmail.com.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04691-y']
95,32371502,Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial.,"OBJECTIVE


Preprocedural bowel preparation is necessary for optimal colonoscopy visualisation. However, it is challenging to achieve high-quality bowel preparation among patients scheduled for colonoscopy. This study aims to evaluate the impact of an intensive patient educational programme on the quality of bowel preparation.
DESIGN


An accessor-blinded randomised controlled trial was carried out at the outpatient surgical clinic of a tertiary hospital. Patients were randomly assigned to the control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme). All subjects completed a questionnaire before colonoscopy to assess their compliance, acceptability, and tolerability towards bowel preparation regime. Quality of bowel preparation was determined using the Boston Bowel Preparation Scale (BBPS).
RESULTS


A total of 300 subjects who fulfilled the inclusion criteria were recruited. The experimental group had a significantly higher proportion of good quality bowel preparation than the control group (98.7% vs 52.3%, p<0.001). The median total BBPS score was also significantly higher in the experimental group (8 vs 5, p<0.001). Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).
CONCLUSION


An intensive patient educational programme can significantly improve the quality of bowel preparation for colonoscopy.",2020,"Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).
","['patients scheduled for colonoscopy', '300 subjects who fulfilled the inclusion criteria were recruited', 'outpatient surgical clinic of a tertiary hospital']","['control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme', 'intensive patient educational programme']","['quality of bowel preparation', 'quality of bowel preparation for colonoscopy', 'Boston Bowel Preparation Scale (BBPS', 'good quality bowel preparation', 'Quality of bowel preparation', 'tolerability towards bowel preparation', 'median total BBPS score', 'good quality of bowel preparation included educational programme', 'compliance to bowel cleansing agent']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0008920', 'cui_str': 'Cleansing Agents'}]",300.0,0.233298,"Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).
","[{'ForeName': 'Sivakami', 'Initials': 'S', 'LastName': 'Janahiraman', 'Affiliation': 'Pharmacy, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia sivakami_5@yahoo.com.'}, {'ForeName': 'Chan Yen', 'Initials': 'CY', 'LastName': 'Tay', 'Affiliation': 'Pharmacy, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Jie Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Pharmacy, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Wen Ling', 'Initials': 'WL', 'LastName': 'Lim', 'Affiliation': 'Pharmacy, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Chun Hoe', 'Initials': 'CH', 'LastName': 'Khiew', 'Affiliation': 'Pharmacy, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Ishak', 'Affiliation': 'Surgical, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Zakry Yahya', 'Initials': 'ZY', 'LastName': 'Onn', 'Affiliation': 'Surgical, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Mohd Razali', 'Initials': 'MR', 'LastName': 'Ibrahim', 'Affiliation': 'Surgical, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Chun Keat', 'Initials': 'CK', 'LastName': 'Chew', 'Affiliation': 'Centre for Clinical Trial, Institute for Clinical Research, Shah Alam, Selangor Darul Ehsan, Malaysia.'}]",BMJ open gastroenterology,['10.1136/bmjgast-2020-000376']
96,32371514,Impact of a farmers' market nutrition coupon programme on diet quality and psychosocial well-being among low-income adults: protocol for a randomised controlled trial and a longitudinal qualitative investigation.,"INTRODUCTION


Low-income populations have poorer diet quality and lower psychosocial well-being than their higher-income counterparts. These inequities increase the burden of chronic disease in low-income populations. Farmers' market subsidies may improve diet quality and psychosocial well-being among low-income populations. In Canada, the British Columbia (BC) Farmers' Market Nutrition Coupon Programme (FMNCP) aims to improve dietary patterns and health among low-income participants by providing coupons to purchase healthy foods from farmers' markets. This study will assess the impact of the BC FMNCP on the diet quality and psychosocial well-being of low-income adults and explore mechanisms of programme impacts.
METHODS AND ANALYSIS


In a parallel group randomised controlled trial, low-income adults will be randomised to an FMNCP intervention (n=132) or a no-intervention control group (n=132). The FMNCP group will receive 16 coupon sheets valued at CAD$21/sheet over 10-15 weeks to purchase fruits, vegetables, dairy, meat/poultry/fish, eggs, nuts and herbs at farmers' markets and will be invited to participate in nutrition skill-building activities. Overall diet quality (primary outcome), diet quality subscores, mental well-being, sense of community, food insecurity and malnutrition risk (secondary outcomes) will be assessed at baseline, immediately post-intervention and 16 weeks post-intervention. Dietary intake will be assessed using the Automated Self-Administered 24-hour Dietary Recall. Diet quality will be calculated using the Healthy Eating Index-2015. Repeated measures mixed-effect regression will assess differences in outcomes between groups from baseline to 16 weeks post-intervention. Furthermore, 25-30 participants will partake in semi-structured interviews during and 5 weeks after programme completion to explore participants' experiences with and perceived outcomes from the programme.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the University of Calgary Conjoint Health Research Ethics Board, Rutgers University Ethics and Compliance, and University of Waterloo Office of Research Ethics. Findings will be disseminated through policy briefs, conference presentations and peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT03952338.",2020,Farmers' Market Nutrition Coupon Programme (FMNCP) aims to improve dietary patterns and health among low-income participants by providing coupons to purchase healthy foods from farmers' markets.,"['among low-income adults', ""low-income participants by providing coupons to purchase healthy foods from farmers' markets"", 'Farmers']","[""farmers' market nutrition coupon programme"", 'FMNCP', 'Market Nutrition Coupon Programme (FMNCP', 'FMNCP intervention (n=132) or a no-intervention control group', 'BC FMNCP']","['burden of chronic disease', 'Diet quality', 'diet quality and psychosocial well-being', 'Overall diet quality (primary outcome), diet quality subscores, mental well-being, sense of community, food insecurity and malnutrition risk (secondary outcomes']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0221460', 'cui_str': 'Farmer'}, {'cui': 'C1318228', 'cui_str': 'Market'}]","[{'cui': 'C0221460', 'cui_str': 'Farmer'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}]","[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",30.0,0.199752,Farmers' Market Nutrition Coupon Programme (FMNCP) aims to improve dietary patterns and health among low-income participants by providing coupons to purchase healthy foods from farmers' markets.,"[{'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Aktary', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Caron-Roy', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Tolulope', 'Initials': 'T', 'LastName': 'Sajobi', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': ""O'Hara"", 'Affiliation': ""British Columbia Association of Farmers' Markets, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Leblanc', 'Affiliation': ""British Columbia Association of Farmers' Markets, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Sharlette', 'Initials': 'S', 'LastName': 'Dunn', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Gavin R', 'Initials': 'GR', 'LastName': 'McCormack', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Timmins', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Ball', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Shauna', 'Initials': 'S', 'LastName': 'Downs', 'Affiliation': 'School of Public Health, Rutgers University, Newark, New Jersey, USA.'}, {'ForeName': 'Leia M', 'Initials': 'LM', 'LastName': 'Minaker', 'Affiliation': 'School of Planning, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Candace Ij', 'Initials': 'CI', 'LastName': 'Nykiforuk', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Godley', 'Affiliation': 'Department of Sociology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Milaney', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Lashewicz', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Fournier', 'Affiliation': 'School of Nursing, Thompson Rivers University, Kamloops, British Columbia, Canada.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Elliott', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Raine', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Rachel Jl', 'Initials': 'RJ', 'LastName': 'Prowse', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Dana Lee', 'Initials': 'DL', 'LastName': 'Olstad', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada dana.olstad@ucalgary.ca.'}]",BMJ open,['10.1136/bmjopen-2019-035143']
97,32379374,Clinical evaluation of the efficacy of trichloroacetic acid 70% after microneedling vs intradermal injection of 5-fluorouracil in the treatment of nonsegmental vitiligo; A prospective comparative study.,"Vitiligo is a skin disorder commonly acquired. Although different therapies are used, they are refractory to therapy in many cases. Trauma has been reported to cause hyperpigmentation by the pigment incontinence, which results in the build-up of melanophages in the upper dermis after basal cell layer destruction. To detect the effectiveness of trichloroacetic acid (TCA) 70% in the treatment of nonsegmental vitiligo after skin microneedling by dermapen or intradermal injection of 5-fluorouracil.
PATIENTS AND METHODS


A prospective comparative study was enrolled with 32 patients with vitiligo who were assigned to two equal groups. Each containing 16 patients; group 1 was treated by microneedling followed by TCA 70%, group 2 was treated by intradermal 5-FU injection. This was done every 2 weeks for 2 months.
RESULTS


According to the Physician's Global Assessment, there was no significant (P < .05) difference in the therapeutic response between the two studied groups.
CONCLUSIONS


Both microneedling plus TCA 70% and 5-FU intradermal injection are a simple means of treating vitiligo with cosmetically accepted repigmentation of all age groups, as well as a relatively safe alternative or additive method that can be used before (or in combination with) any of the well-known and widely approved method for stable nonsegmented vitiligo treatment.",2020,"According to the Physician's Global Assessment, there was no significant (P < 0.","['A prospective comparative study was enrolled with thirty- two patients with vitiligo who were assigned to two equal groups', 'non-segmental vitiligo after skin micro-needling by dermapen or intradermal injection of', 'non-segmental vitiligo']","['trichloroacetic acid (TCA', '5-FU intradermal injection', 'intradermal 5-FU injection', 'trichloroacetic acid 70% after micro-needling vs intradermal injection of 5-fluorouracil', 'micro-needling followed by TCA', '5-fluorouracil']",['therapeutic response'],"[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009491', 'cui_str': 'Comparative Studies'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1274648', 'cui_str': 'Segmental vitiligo'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}]","[{'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0521982', 'cui_str': 'Response to treatment'}]",32.0,0.0177793,"According to the Physician's Global Assessment, there was no significant (P < 0.","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Khater', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Nasr', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Salah', 'Affiliation': 'Dermatology Resident, Belbis Hospital, Egypt.'}, {'ForeName': 'Fathia M', 'Initials': 'FM', 'LastName': 'Khattab', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13532']
98,32356923,Evaluating the Perceived Efficacy of Randomized Security Measures at Airports.,"Both the increase in traveler numbers and the heightened threat posed by terrorism in recent years represent significant challenges to airport security measures. To ensure that a high level of security is maintained, randomized security checks have been proposed as a promising alternative to traditional security approaches. The use of randomized checks means that only a specific number of people are selected for security screening. However, the likely effects of such a change in security procedures on travelers' security perceptions and on the deterrence of criminal activities remain unclear. Thus, the present study examines how varying the percentage of people screened during security checks influences people's security perceptions. In two online experiments, the participants were asked to imagine that they sought to smuggle an explosive dummy past an airport security check. The only information provided was the number of people screened during security checks, which was manipulated between-subjects in the first experiment and within-subjects in the second experiment. The participants then had to rate their security perception (i.e., the perceived likelihood of successfully smuggling the explosive dummy). The findings show that people perceive traditional security checks to be safer than randomized checks, irrespective of whether 90% or 30% of people are screened. Hence, if randomized security checks would indeed be implemented, it would automatically lead to a decreased perception of security. Furthermore, this decreased security perception might lead to an actual reduction in security, as the deterrence of criminal activities could also be reduced.",2020,"The findings show that people perceive traditional security checks to be safer than randomized checks, irrespective of whether 90% or 30% of people are screened.",[],[],['rate their security perception'],[],[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0315659,"The findings show that people perceive traditional security checks to be safer than randomized checks, irrespective of whether 90% or 30% of people are screened.","[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Stotz', 'Affiliation': 'ETH Zurich, Consumer Behavior, Zurich, 8092, Switzerland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bearth', 'Affiliation': 'ETH Zurich, Consumer Behavior, Zurich, 8092, Switzerland.'}, {'ForeName': 'Signe Maria', 'Initials': 'SM', 'LastName': 'Ghelfi', 'Affiliation': 'Zurich State Police, Airport Division - Research and Development, P.O. Box, Zurich-Airport, 8058, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Siegrist', 'Affiliation': 'ETH Zurich, Consumer Behavior, Zurich, 8092, Switzerland.'}]",Risk analysis : an official publication of the Society for Risk Analysis,['10.1111/risa.13474']
99,32361126,Kinetic parameters during land and water walking performed by individuals with Down Syndrome.,"BACKGROUND


Down Syndrome (DS) is a genetic condition presenting delay in acquisition of main motor milestones, such as walking. Although studies have been investigating the biomechanical parameters during land walking performed by individual with DS, the literature is scarce regarding kinetic parameters analysis in this population, specially during water walking.
RESEARCH QUESTION


This study sought to assess the vertical ground reaction force (Fz) of walking performed in water and on land at different speeds by individuals with DS.
METHODS


Fourteen adults with DS (age: 27.9 ± 7.9 years; body mass: 58.4 ± 12.9 kg; height: 1.4 ± 0.1 m, body mass index: 29.2 ± 5.4 kg.m -2 ) completed two sessions of data collection, one on land and another in aquatic environment. The protocol consisted of walking performed at three self-selected speeds (slow, comfortable and fast) in randomized order. The Fz was assessed with a waterproof force plate in each condition. Two-way repeated-measures ANOVA (environment and speed), with Bonferroni's post hoc tests, were used for analysis. A significance level was set as α = 0.05.
RESULTS


Significant differences were observed between environments (p < 0.001), with reduced first peak of Fz (68-73%), second peak of Fz (66-70%), loading rate (75-78%) and impulse (40-41%) in the water walking for all speeds analyzed. In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking. Moreover, the loading rate significantly increased (p = 0.019) as the impulse significantly reduced (p < 0.001) in the higher speeds.
SIGNIFICANCE


Individuals with DS present reduced Fz outcomes during water walking in comparison to land. Therefore, water walking may be performed by individuals with DS with safe vertical loads on lower limbs regardless the self-selected speed for rehabilitation, correction of gait and training purposes.",2020,"In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking.","['individuals with DS', 'individuals with Down Syndrome', 'Individuals with DS present', 'Fourteen adults with DS (age: 27.9\u2009±\u20097.9 years; body mass: 58.4\u2009±\u200912.9\u2009kg; height: 1.4\u2009±\u20090.1\u2009m, body mass index: 29.2\u2009±\u20095.4\u2009kg.m -2 ) completed two sessions of data collection, one on land and another in aquatic environment']",['vertical ground reaction force (Fz) of walking performed in water and on land'],"['speed of walking', 'second peak of Fz', 'reduced Fz outcomes', 'loading rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0563034', 'cui_str': 'Aquatic environment'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0557668', 'cui_str': 'Landing'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",14.0,0.0231467,"In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking.","[{'ForeName': 'Gabriela Neves', 'Initials': 'GN', 'LastName': 'Nunes', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Stephanie Santana', 'Initials': 'SS', 'LastName': 'Pinto', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Gabriele Randuz', 'Initials': 'GR', 'LastName': 'Krüger', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Leonardo Alexandre', 'Initials': 'LA', 'LastName': 'Peyré-Tartaruga', 'Affiliation': 'Exercise Research Laboratory, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luana Siqueira', 'Initials': 'LS', 'LastName': 'Andrade', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Graciele Ferreira', 'Initials': 'GF', 'LastName': 'Mendes', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Vitor de Lima', 'Initials': 'VL', 'LastName': 'Krüger', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Rochele Barboza', 'Initials': 'RB', 'LastName': 'Pinheiro', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Alexandre Carriconde', 'Initials': 'AC', 'LastName': 'Marques', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Cristine Lima', 'Initials': 'CL', 'LastName': 'Alberton', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil. Electronic address: tinialberton@yahoo.com.br.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.017']
100,32360692,Acute and residual mood and cognitive performance of young adults following smoked cannabis.,"OBJECTIVES


To examine acute and residual mood and cognitive performance in young adult regular cannabis users following smoked cannabis.
METHODS


Ninety-one healthy young adults completed this double-blind, placebo-controlled, parallel-groups study. Participants were randomized to receive active (12.5% THC) or placebo cannabis with a 2:1 allocation ratio, and mood [Profile of Mood States (POMS)] and cognitive performance [Hopkins Verbal Learning Test - Revised (HVLT-R), Digit Symbol Substitution Test (DSST), Continuous Performance Test (CPT), grooved pegboard (GPB)] were assessed before and 1, 24, and 48 (h) after smoking cannabis ad libitum. High and Low THC groups were based on blood THC concentrations.
RESULTS


One hour after smoking cannabis, compared to Placebo, in both the High and Low THC groups, there were increases in POMS Arousal and Positive Mood, and in the High THC group only, increases in Confusion, Friendliness, and Elation, and a decrease in Fatigue. Increases in Friendliness and Elation in the High THC group remained significant for 24 h. The only significant acute effect of cannabis on cognition was a decrease in the percent of words retained in the HVLT-R in the High THC group compared to Placebo (mean difference = 15.8%, 95% CI = 3.6-28.0%, p = 0.006). Unexpectedly, compared to Placebo, both the High and Low THC groups improved in DSST performance at 48 h (p ≤ 0.016).
CONCLUSIONS


Under the present experimental conditions, in young regular cannabis users, smoking cannabis ad libitum had significant effects on mood, some of which persisted 24 h later, yet minimal effects on cognition, and no evidence of residual cognitive impairment.",2020,"Unexpectedly, compared to Placebo, both the High and Low THC groups improved in DSST performance at 48 h (p ≤ 0.016).
","['young adult regular cannabis users following smoked cannabis', 'Ninety-one healthy young adults', 'young adults following smoked cannabis', 'young regular cannabis users']","['High and Low', 'Placebo', 'placebo cannabis with a 2:1 allocation ratio, and mood', 'placebo']","['Confusion, Friendliness, and Elation', 'blood THC concentrations', 'Fatigue', 'Mood States (POMS)] and cognitive performance [Hopkins Verbal Learning Test - Revised (HVLT-R), Digit Symbol Substitution Test (DSST), Continuous Performance Test (CPT), grooved pegboard (GPB', 'Friendliness and Elation', 'Acute and residual mood and cognitive performance', 'POMS Arousal and Positive Mood', 'DSST performance']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0233492', 'cui_str': 'Elation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C3490329', 'cui_str': 'glycerol phenylbutyrate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",91.0,0.263829,"Unexpectedly, compared to Placebo, both the High and Low THC groups improved in DSST performance at 48 h (p ≤ 0.016).
","[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Matheson', 'Affiliation': ""Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, 27 King's College Circle, Toronto, Ontario M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada. Electronic address: justin.matheson@camh.ca.""}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Mann', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario M5T3M7, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Sproule', 'Affiliation': 'Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S3M2, Canada; Pharmacy Department, Centre for Addiction and Mental Health, 1001 Queen Street, Toronto, Ontario M6J1H4, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Marilyn A', 'Initials': 'MA', 'LastName': 'Huestis', 'Affiliation': 'Institute of Emerging Health Professions, Thomas Jefferson University, 1020 Walnut Street, Philadelphia, PA 19107, United States.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Wickens', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario M5T3M7, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Stoduto', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada.'}, {'ForeName': 'Tony P', 'Initials': 'TP', 'LastName': 'George', 'Affiliation': ""Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada; Addictions Division, Centre for Addiction and Mental Health, 100 Stokes Street, Toronto, Ontario M6J1H4, Canada; Institute of Medical Sciences, University of Toronto, 1 King's College Circle, Room 2374, Toronto, Ontario M5S 1A8, Canada.""}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rehm', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario M5T3M7, Canada; Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 250 College Street, Toronto, Ontario M5T1R8, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': ""Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, 27 King's College Circle, Toronto, Ontario M5S3H7, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, Toronto, Ontario M5T1R8, Canada; Addictions Division, Centre for Addiction and Mental Health, 100 Stokes Street, Toronto, Ontario M6J1H4, Canada; Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Department of Family and Community Medicine, University of Toronto, 500 University Avenue, 5th Floor, Toronto, Ontario M5G 1V7, Canada.""}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Brands', 'Affiliation': ""Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, 27 King's College Circle, Toronto, Ontario M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario M5S2S1, Canada; Controlled Substances and Cannabis Directorate, Health Canada, Ottawa, Ontario, Canada.""}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.172937']
101,32370818,"Effect of antidepressants for cessation therapy in betel-quid use disorder: a randomised, double-blind, placebo-controlled trial.","AIMS


More than one-half of betel-quid (BQ) chewers have betel-quid use disorder (BUD). However, no medication has been approved. We performed a randomised clinical trial to test the efficacy of taking escitalopram and moclobemide antidepressants on betel-quid chewing cessation (BQ-CC) treatment.
METHODS


We enrolled 111 eligible male BUD patients. They were double-blinded, placebo-controlled and randomised into three treatment groups: escitalopram 10 mg/tab daily, moclobemide 150 mg/tab daily and placebo. Patients were followed-up every 2 weeks and the length of the trial was 8 weeks. The primary outcome was BQ-CC, defined as BUD patients who continuously stopped BQ use for ⩾6 weeks. The secondary outcomes were the frequency and amount of BQ intake, and two psychological rating scales. Several clinical adverse effects were measured during the 8-week treatment.
RESULTS


Intention-to-treat analysis shows that after 8 weeks, two (5.4%), 13 (34.2%) and 12 (33.3%) of BUD patients continuously quit BQ chewing for ⩾6 weeks among placebo, escitalopram, moclobemide groups, respectively. The adjusted proportion ratio of BQ-CC was 6.3 (95% CI 1.5-26.1) and 6.8 (95% CI 1.6-28.0) for BUD patients who used escitalopram and moclobemide, respectively, as compared with those who used placebo. BUD patients with escitalopram and moclobemide treatments both exhibited a significantly lower frequency and amount of BQ intake at the 8th week than those with placebo.
CONCLUSIONS


Prescribing a fixed dose of moclobemide and escitalopram to BUD patients over 8 weeks demonstrated treatment benefits to BQ-CC. Given a relatively small sample, this study provides preliminary evidence and requires replication in larger trials.",2020,"The adjusted proportion ratio of BQ-CC was 6.3 (95% CI 1.5-26.1) and 6.8 (95% CI 1.6-28.0) for BUD patients who used escitalopram and moclobemide, respectively, as compared with those who used placebo.","['BUD patients with escitalopram and', 'betel-quid use disorder', '111 eligible male BUD patients']","['placebo', 'moclobemide', 'escitalopram and moclobemide antidepressants', 'antidepressants', 'escitalopram 10 mg/tab daily, moclobemide 150 mg/tab daily and placebo']","['frequency and amount of BQ intake, and two psychological rating scales', 'frequency and amount of BQ intake', 'BQ-CC', 'adjusted proportion ratio of BQ-CC']","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0066673', 'cui_str': 'Moclobemide'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1168577', 'cui_str': 'Escitalopram 10 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1128430', 'cui_str': 'Moclobemide 150 MG'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",111.0,0.638953,"The adjusted proportion ratio of BQ-CC was 6.3 (95% CI 1.5-26.1) and 6.8 (95% CI 1.6-28.0) for BUD patients who used escitalopram and moclobemide, respectively, as compared with those who used placebo.","[{'ForeName': 'Chung-Chieh', 'Initials': 'CC', 'LastName': 'Hung', 'Affiliation': 'Graduate Institute of Clinical Medical Science, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health and Research Center for Environment Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Albert Min-Shan', 'Initials': 'AM', 'LastName': 'Ko', 'Affiliation': 'Key Laboratory of Vertebrate Evolution and Human Origins of Chinese Academy of Sciences, Institute of Vertebrate Paleontology and Paleoanthropology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hsien-Yuan', 'Initials': 'HY', 'LastName': 'Lane', 'Affiliation': 'Graduate Institute of Clinical Medical Science, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chi-Pin', 'Initials': 'CP', 'LastName': 'Lee', 'Affiliation': 'Environment-Omics-Disease Research Center, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Ying-Chin', 'Initials': 'YC', 'LastName': 'Ko', 'Affiliation': 'Environment-Omics-Disease Research Center, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796020000384']
102,32370822,Liver resection surgery compared with thermal ablation in high surgical risk patients with colorectal liver metastases: the LAVA international RCT.,"BACKGROUND


Although surgical resection has been considered the only curative option for colorectal liver metastases, thermal ablation has recently been suggested as an alternative curative treatment. There have been no adequately powered trials comparing surgery with thermal ablation.
OBJECTIVES


Main objective - to compare the clinical effectiveness and cost-effectiveness of thermal ablation versus liver resection surgery in high surgical risk patients who would be eligible for liver resection. Pilot study objectives - to assess the feasibility of recruitment (through qualitative study), to assess the quality of ablations and liver resection surgery to determine acceptable standards for the main trial and to centrally review the reporting of computed tomography scan findings relating to ablation and outcomes and recurrence rate in both arms.
DESIGN


A prospective, international (UK and the Netherlands), multicentre, open, pragmatic, parallel-group, randomised controlled non-inferiority trial with a 1-year internal pilot study.
SETTING


Tertiary liver, pancreatic and gallbladder (hepatopancreatobiliary) centres in the UK and the Netherlands.
PARTICIPANTS


Adults with a specialist multidisciplinary team diagnosis of colorectal liver metastases who are at high surgical risk because of their age, comorbidities or tumour burden and who would be suitable for liver resection or thermal ablation.
INTERVENTIONS


Thermal ablation conducted as per local policy (but centres were encouraged to recruit within Cardiovascular and Interventional Radiological Society of Europe guidelines) versus surgical liver resection performed as per centre protocol.
MAIN OUTCOME MEASURES


Pilot study - patients' and clinicians' acceptability of the trial to assist in optimisation of recruitment. Primary outcome - disease-free survival at 2 years post randomisation. Secondary outcomes - overall survival, timing and site of recurrence, additional therapy after treatment failure, quality of life, complications, length of hospital stay, costs, trial acceptability, and disease-free survival measured from end of intervention. It was planned that 5-year survival data would be documented through record linkage. Randomisation was performed by minimisation incorporating a random element, and this was a non-blinded study.
RESULTS


In the pilot study over 1 year, a total of 366 patients with colorectal liver metastases were screened and 59 were considered eligible. Only nine participants were randomised. The trial was stopped early and none of the planned statistical analyses was performed. The key issues inhibiting recruitment included fewer than anticipated patients eligible for both treatments, misconceptions about the eligibility criteria for the trial, surgeons' preference for one of the treatments ('lack of clinical equipoise' among some of the surgeons in the centre) with unconscious bias towards surgery, patients' preference for one of the treatments, and lack of dedicated research nurses for the trial.
CONCLUSIONS


Recruitment feasibility was not demonstrated during the pilot stage of the trial; therefore, the trial closed early. In future, comparisons involving two very different treatments may benefit from an initial feasibility study or a longer period of internal pilot study to resolve these difficulties. Sufficient time should be allowed to set up arrangements through National Institute for Health Research (NIHR) Research Networks.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN52040363.
FUNDING


This project was funded by the NIHR Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 21. See the NIHR Journals Library website for further project information.",2020,"Secondary outcomes - overall survival, timing and site of recurrence, additional therapy after treatment failure, quality of life, complications, length of hospital stay, costs, trial acceptability, and disease-free survival measured from end of intervention.","['366 patients with colorectal liver metastases were screened and 59 were considered eligible', ""patients eligible for both treatments, misconceptions about the eligibility criteria for the trial, surgeons' preference for one of the treatments ('lack of clinical equipoise' among some of the surgeons in the centre) with unconscious bias towards surgery, patients' preference for one of the treatments, and lack of dedicated research nurses for the trial"", 'high surgical risk patients with colorectal liver metastases', 'high surgical risk patients who would be eligible for liver resection', 'Tertiary liver, pancreatic and gallbladder (hepatopancreatobiliary) centres in the UK and the Netherlands', 'Adults with a specialist multidisciplinary team diagnosis of colorectal liver metastases who are at high surgical risk because of their age, comorbidities or tumour burden and who would be suitable for liver resection or thermal ablation']","['thermal ablation', 'Liver resection surgery', 'thermal ablation versus liver resection surgery', 'surgical liver resection performed as per centre protocol']","['overall survival, timing and site of recurrence, additional therapy after treatment failure, quality of life, complications, length of hospital stay, costs, trial acceptability, and disease-free survival', 'clinical effectiveness and cost-effectiveness', '5-year survival data', 'disease-free survival', 'recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0702057', 'cui_str': 'Equipoise'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041654', 'cui_str': 'Unconscious (Psychology)'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0687693', 'cui_str': 'Research nurse'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1319406', 'cui_str': 'Specialist multidisciplinary team'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0677798', 'cui_str': 'Thermal ablation'}]","[{'cui': 'C0677798', 'cui_str': 'Thermal ablation'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}]",366.0,0.249057,"Secondary outcomes - overall survival, timing and site of recurrence, additional therapy after treatment failure, quality of life, complications, length of hospital stay, costs, trial acceptability, and disease-free survival measured from end of intervention.","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Davidson', 'Affiliation': 'Royal Free Campus, Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Kurinchi', 'Initials': 'K', 'LastName': 'Gurusamy', 'Affiliation': 'Royal Free Campus, Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Corrigan', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Croft', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Ruddock', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Pullan', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Twiddy', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Jaqueline', 'Initials': 'J', 'LastName': 'Birtwistle', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Department of Applied Health Research, University College London, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Woodward', 'Affiliation': 'Radiology, Royal Free Hospital, London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Bandula', 'Affiliation': 'Radiology, University College Hospital, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hochhauser', 'Affiliation': 'Cancer Institute, University College London, London, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Prasad', 'Affiliation': 'Surgery and Transplantation, Leeds Teaching Hospital, Leeds, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Olde Damink', 'Affiliation': 'General Surgery, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Coolson', 'Affiliation': 'General Surgery, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'K van', 'Initials': 'KV', 'LastName': 'Laarhoven', 'Affiliation': 'Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Johannes Hw', 'Initials': 'JH', 'LastName': 'de Wilt', 'Affiliation': 'Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24210']
103,32375553,Prediction of Residual Risk by Ceramide-Phospholipid Score in Patients With Stable Coronary Heart Disease on Optimal Medical Therapy.,"Background Identification of patients with stable coronary heart disease who are at significant residual risk could be helpful for targeted prevention. Our aim was to determine the prognostic value of the recently introduced ceramide- and phospholipid-based risk score, the Cardiovascular Event Risk Test (CERT2), in patients with stable coronary heart disease on optimal medical therapy and to identify biological processes that contribute to the CERT2 score. Methods and Results Plasma samples (n=11 222) obtained from the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) trial were analyzed using a tandem liquid chromatography-mass spectrometry method. STABILITY was a trial in patients with stable coronary heart disease randomized to the lipoprotein-associated phospholipase A2 inhibitor darapladib or placebo on optimized medical therapy at baseline, with a median follow-up of 3.7 years. Hazard ratios per SD for the CERT2 risk score were 1.32 (95% CI, 1.25-1.39) for major adverse cardiovascular event, 1.47 (95% CI, 1.35-1.59) for cardiovascular death, 1.32 (95% CI, 1.16-1.49) for stroke, 1.23 (95% CI, 1.14-1.33) for myocardial infarction, and 1.56 (95% CI, 1.39-1.76) for hospitalization due to heart failure, when adjusted for traditional cardiovascular risk factors. CERT2 showed correlation ( P <0.001,  r >0.2) with inflammatory markers high-sensitivity C-reactive protein, interleukin 6, the heart failure marker N-terminal pro-B-type natriuretic peptide, and low-density lipoprotein cholesterol. After also adjusting for levels of other prognostic biomarkers, the CERT2 score was still independently related to the risk of cardiovascular death but not to nonfatal events. Conclusions The CERT2 risk score can detect residual risk in patients with stable coronary heart disease and is associated with biomarkers indicating inflammation, myocardial necrosis, myocardial dysfunction, renal dysfunction, and dyslipidemia. REGISTRATION URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT00799903.",2020,"Hazard ratios per SD for the CERT2 risk score were 1.32 (95% CI, 1.25-1.39) for major adverse cardiovascular event, 1.47 (95% CI, 1.35-1.59) for cardiovascular death, 1.32 (95% CI, 1.16-1.49) for stroke, 1.23 (95% CI, 1.14-1.33) for myocardial infarction, and 1.56 (95% CI, 1.39-1.76) for hospitalization due to heart failure, when adjusted for traditional cardiovascular risk factors.","['patients with stable coronary heart disease on optimal medical therapy', 'on optimized medical therapy at baseline, with a median follow-up of 3.7\xa0years', 'patients with stable coronary heart disease randomized to the', 'patients with stable coronary heart disease', 'Patients With Stable Coronary Heart Disease on Optimal Medical Therapy']",['lipoprotein-associated phospholipase A2 inhibitor darapladib or placebo'],"['myocardial infarction', 'Hazard ratios per SD for the CERT2 risk score', 'cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0893636', 'cui_str': 'phospholipase A2 inhibitor'}, {'cui': 'C2348075', 'cui_str': 'darapladib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0533902,"Hazard ratios per SD for the CERT2 risk score were 1.32 (95% CI, 1.25-1.39) for major adverse cardiovascular event, 1.47 (95% CI, 1.35-1.59) for cardiovascular death, 1.32 (95% CI, 1.16-1.49) for stroke, 1.23 (95% CI, 1.14-1.33) for myocardial infarction, and 1.56 (95% CI, 1.39-1.76) for hospitalization due to heart failure, when adjusted for traditional cardiovascular risk factors.","[{'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Hilvo', 'Affiliation': 'Zora Biosciences Oy Espoo Finland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences Uppsala University Uppsala Sweden.'}, {'ForeName': 'Tatevik', 'Initials': 'T', 'LastName': 'Ghukasyan Lakic', 'Affiliation': 'Uppsala Clinical Research Center Uppsala Sweden.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Held', 'Affiliation': 'Department of Medical Sciences Uppsala University Uppsala Sweden.'}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Kauhanen', 'Affiliation': 'Zora Biosciences Oy Espoo Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Jylhä', 'Affiliation': 'Zora Biosciences Oy Espoo Finland.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lindbäck', 'Affiliation': 'Uppsala Clinical Research Center Uppsala Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Siegbahn', 'Affiliation': 'Department of Medical Sciences Uppsala University Uppsala Sweden.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Medical Center Duke University Durham NC.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Koenig', 'Affiliation': 'Deutsches Herzzentrum München Technische Universität München München Germany and DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance Munich Germany.'}, {'ForeName': 'Ralph A H', 'Initials': 'RAH', 'LastName': 'Stewart', 'Affiliation': 'N Green Lane Cardiovascular Service Auckland City Hospital and University of Auckland New Zealand.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'White', 'Affiliation': 'N Green Lane Cardiovascular Service Auckland City Hospital and University of Auckland New Zealand.'}, {'ForeName': 'Reijo', 'Initials': 'R', 'LastName': 'Laaksonen', 'Affiliation': 'Zora Biosciences Oy Espoo Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.119.015258']
104,32381843,Adjunctive Effect of Doxycycline with Conventional Periodontal Therapy on Glycemic Level for Chronic Periodontitis with Type 2 Diabetes Mellitus Subjects.,"AIMS


This study aimed to assess the use of doxycycline in adjunct to periodontal therapy on the glycemic levels for chronic periodontitis patients with type 2 diabetes mellitus (DM).
MATERIALS AND METHODS


Fifty-one diabetic subjects with chronic periodontitis were selected and randomly assigned into 3 groups with 17 subjects each. Scaling and root planing (SRP) was done in group I, SRP and doxycycline was given in group II, and group III did not receive any periodontal treatment till 3 months. Probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and metabolic parameters were evaluated at baseline (day 0) and after 3 months (day 90). The statistical analysis was carried out using SPSS 17.0 software with significance fixed at 95% CI ( p  < 0.05).
RESULTS


The mean difference between baseline and day 90 for all periodontal parameters was significantly higher ( p  < 0.01) in group I and group II compared to control (group III). The metabolic parameters such as fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG), and glycated hemoglobin (HbA1c%) level were reduced in groups I and II compared to group III; however, only HbA1c% values were found significantly reduced ( p  < 0.01) at day 90. Group II showed significantly better metabolic parameters than group I at day 90.
CONCLUSION


The adjunct of doxycycline to conventional periodontal therapy provides additional benefit in reducing glycemic level and improves periodontal health.
CLINICAL SIGNIFICANCE


The prevalence of diabetes as well as periodontitis is increasing nowadays in the world. With treatment of periodontitis, it is found that there is reduction of glycemic level in diabetes. So it is an alert to health professionals about the relation of diabetes and periodontitis and so that they conduct a multidisciplinary treatment.",2019,"Probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and metabolic parameters were evaluated at baseline (day 0) and after 3 months (day 90).","['Chronic Periodontitis with Type 2 Diabetes Mellitus Subjects', 'chronic periodontitis patients with type 2 diabetes mellitus (DM', 'Fifty-one diabetic subjects with chronic periodontitis']","['doxycycline', 'Scaling and root planing (SRP', 'SRP and doxycycline', 'Doxycycline with Conventional Periodontal Therapy', 'periodontal therapy']","['glycemic levels', 'fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG), and glycated hemoglobin (HbA1c%) level', 'Glycemic Level', 'metabolic parameters', 'Probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and metabolic parameters', 'glycemic level and improves periodontal health']","[{'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",51.0,0.0174445,"Probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and metabolic parameters were evaluated at baseline (day 0) and after 3 months (day 90).","[{'ForeName': 'Abhaya C', 'Initials': 'AC', 'LastName': 'Das', 'Affiliation': ""Department of Periodontics and Oral Implantology, Institute of Dental Sciences, Siksha 'O' Anusandhan (Deemed to be university), Bhubaneswar, Odisha, India, Phone: +91 9437088379, e-mail: drabhaya2011@gmail.com.""}, {'ForeName': 'Swarga J', 'Initials': 'SJ', 'LastName': 'Das', 'Affiliation': 'Department of Periodontics and Oral Implantology, Regional Dental College, Guwahati, Assam, India.'}, {'ForeName': 'Saurav', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': ""Department of Periodontics and Oral Implantology, Institute of Dental Sciences, Siksha 'O' Anusandhan (Deemed to be university), Bhubaneswar, Odisha, India.""}, {'ForeName': 'Dipti', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Endocrinology, Gauhati Medical College, Guwahati, Assam, India.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Taschieri', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, IRCCS Galeazzi Orthopedic Institute, Milan, Lombardia, Italy.'}, {'ForeName': 'Massimo D', 'Initials': 'MD', 'LastName': 'Fabbro', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, IRCCS Galeazzi Orthopedic Institute, Milan, Lombardia, Italy.'}]",The journal of contemporary dental practice,[]
105,32356559,Physical activity and markers of glycation in older individuals: data from a combined cross-sectional and randomized controlled trial (EXAMIN AGE).,"BACKGROUND


Advanced glycation end products (AGEs) are protein modifications that are predominantly formed from dicarbonyl compounds that arise from glucose and lipid metabolism. AGEs and sedentary behavior have been identified as a driver of accelerated (vascular) aging. The effect of physical activity on AGE accumulation is unknown. Therefore, we investigated whether plasma AGEs and dicarbonyl levels are different across older individuals that were active or sedentary and whether plasma AGEs are affected by high-intensity interval training (HIIT).
METHODS


We included healthy older active (HA, n=38, 44.7% female, 60.1 ± 7.7 years old) and healthy older sedentary (HS, n=36, 72.2% female, 60.0 ± 7.3 years old) individuals as well as older sedentary individuals with increased cardiovascular risk (SR, n=84, 50% female, 58.7 ± 6.6 years old). The SR group was randomized into a 12-week walking-based HIIT program or control group. We measured protein-bound and free plasma AGEs and dicarbonyls by ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) at baseline and after the HIIT intervention.
RESULTS


Protein-bound AGE Nε-(carboxymethyl)lysine (CML) was lower in SR (2.6 ± 0.5 μmol/l) and HS (3.1 ± 0.5 μmol/l) than in HA (3.6 ± 0.6 μmol/l; P<0.05) and remained significantly lower after adjustment for several potential confounders. None of the other glycation markers were different between HS and HA. HIIT did not change plasma AGEs and dicarbonyls in SR.
DISCUSSION


Although lifestyle interventions may act as important modulators of cardiovascular risk, HIIT is not a potent short-term intervention to reduce glycation in older individuals, underlining the need for other approaches, such as pharmacological agents, to reduce AGEs and lower cardiovascular risk in this population.",2020,"HIIT did not change plasma AGEs and dicarbonyls in SR.
","['older individuals that were active or sedentary and whether plasma AGEs are affected by high intensity interval training (HIIT', 'older individuals', 'healthy older active (HA,\xa0n=38, 44.7% female, 60.1±7.7 years old) and healthy older sedentary (HS,\xa0n=36, 72.2% female, 60.0±7.3 years old) individuals as well as older sedentary individuals with increased cardiovascular risk (SR,\xa0n=84, 50% female, 58.7±6.6 years old']",['walking-based HIIT program or control group'],"['plasma AGEs and dicarbonyl levels', 'Physical activity and markers of glycation', 'protein-bound and free plasma AGEs and dicarbonyls by UPLC-MS/MS']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033618', 'cui_str': 'Protein binding'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}]",,0.0486955,"HIIT did not change plasma AGEs and dicarbonyls in SR.
","[{'ForeName': 'Mathias D G', 'Initials': 'MDG', 'LastName': 'Van den Eynde', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Streese', 'Affiliation': 'Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Alfons J H M', 'Initials': 'AJHM', 'LastName': 'Houben', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Coen D A', 'Initials': 'CDA', 'LastName': 'Stehouwer', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Jean L J M', 'Initials': 'JLJM', 'LastName': 'Scheijen', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Casper G', 'Initials': 'CG', 'LastName': 'Schalkwijk', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Nordin M J', 'Initials': 'NMJ', 'LastName': 'Hanssen', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Henner', 'Initials': 'H', 'LastName': 'Hanssen', 'Affiliation': 'Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}]","Clinical science (London, England : 1979)",['10.1042/CS20200255']
106,32360392,A randomized controlled trial of transcranial direct-current stimulation and cognitive training in children with fetal alcohol spectrum disorder.,"BACKGROUND


This study was a randomized double-blind sham-controlled trial examining the effects of transcranial direct current stimulation (tDCS) augmented cognitive training (CT) in children with Fetal Alcohol Spectrum Disorders (FASD). Prenatal alcohol exposure has profound detrimental effects on brain development and individuals with FASD commonly present with deficits in executive functions including attention and working memory. The most commonly studied treatment for executive deficits is CT, which involves repeated drilling of exercises targeting the impaired functions. As currently implemented, CT requires many hours and the observed effect sizes are moderate. Neuromodulation via tDCS can enhance brain plasticity and prior studies demonstrate that combining tDCS with CT improves efficacy and functional outcomes. TDCS-augmented CT has not yet been tested in FASD, a condition in which there are known abnormalities in neuroplasticity and few interventions.
METHODS


This study examined the feasibility and efficacy of this approach in 44 children with FASD. Participants were randomized to receive five sessions of CT with either active or sham tDCS targeting the dorsolateral prefrontal cortex, a region of the brain that is heavily involved in executive functioning.
RESULTS


The intervention was feasible and well-tolerated in children with FASD. The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p = .043). Group differences were observed at the third, fourth and fifth treatment sessions. There was no effect of tDCS on working memory (p = .911). Further, we found no group differences on a trail making task (p = .659) or on the verbal fluency test (p = .826). In the active tDCS group, a significant correlation was observed between improvement in attention scores and decrease in parent-reported attention deficits (p = .010).
CONCLUSIONS


These results demonstrate that tDCS-augmented CT is well tolerated in children with FASD and potentially offers benefits over and above CT alone.",2020,The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p=.043).,"['children with fetal alcohol spectrum disorder', 'children with Fetal Alcohol Spectrum Disorders (FASD', 'children with FASD', '44 children with FASD']","['CT with either active or sham tDCS', 'transcranial direct current stimulation (tDCS) augmented cognitive training (CT', 'transcranial direct-current stimulation and cognitive training', 'tDCS', 'tDCS-augmented CT', 'CT', 'TDCS-augmented CT']","['feasibility and efficacy', 'trail making task', 'attention scores and decrease in parent-reported attention deficits', 'attention on a continuous performance test']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015923', 'cui_str': 'Fetal alcohol syndrome'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",44.0,0.0938664,The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p=.043).,"[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Boroda', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Krueger', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Bansal', 'Affiliation': 'University of Maryland, USA.'}, {'ForeName': 'Mariah J', 'Initials': 'MJ', 'LastName': 'Schumacher', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Abhrajeet V', 'Initials': 'AV', 'LastName': 'Roy', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Boys', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Kelvin O', 'Initials': 'KO', 'LastName': 'Lim', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Wozniak', 'Affiliation': 'University of Minnesota, Twin Cities, USA. Electronic address: jwozniak@umn.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.04.015']
107,32360399,Effect of different exercise training intensities on musculoskeletal and neuropathic pain in inactive individuals with type 2 diabetes - Preliminary randomised controlled trial.,"AIMS


People with type 2 diabetes (T2D) have a greater prevalence of musculoskeletal and neuropathic pain. This exploratory analysis investigated whether exercise of different intensities leads to changes in self-reported musculoskeletal pain or symptoms of diabetic neuropathy in inactive individuals with type 2 diabetes.
METHODS


Thirty-two inactive adults with T2D (59% male, mean age 58.7 ± 9.1yrs, median HbA 1c  7.8%) were randomised to usual care (CON), supervised combined aerobic and resistance moderate-intensity continuous training (C-MICT), or supervised combined high-intensity interval training (C-HIIT). At baseline and 8-weeks, musculoskeletal and neuropathic pain were evaluated using a modified Nordic Musculoskeletal Questionnaire and the Neuropathy Total Symptom Score-6 respectively. Quantitative sensory testing was used to determine thermal, mechanical and vibration detection thresholds, as well as pain pressure thresholds. Adverse events were recorded throughout the intervention.
RESULTS


Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [-10.6 to -0.2], p = 0.04) and non-significantly greater for C-MICT (MD -5.9 [-12.4 to 0.7], p = 0.08). Changes in neuropathy symptoms were not different between C-HIIT and CON (MD 1.0 [-0.9 to 2.8], p = 0.31), or C-MICT and CON (MD 0.2 [-3.1 to 3.6], p = 0.89). No differences in sensory function were observed between groups. Similar rates of adverse events were seen in both exercise interventions (19 C-HIIT; 17 C-MICT), all but one of which were mild.
CONCLUSIONS


Preliminary data suggests 8-weeks of high-intensity combined aerobic and resistance exercise may be safely prescribed for inactive individuals with T2D and may reduce musculoskeletal pain but not neuropathic symptoms.
TRIAL REGISTRATION


ACTRN12615000475549.",2020,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","['inactive individuals with type 2 diabetes', 'Thirty-two inactive adults with T2D (59% male, mean age 58.7±9.1yrs, median HbA 1c  7.8', 'People with type 2 diabetes (T2D', 'Inactive Individuals with Type 2 Diabetes']","['usual care (CON), supervised combined aerobic and resistance moderate-intensity continuous training (C-MICT), or supervised combined high-intensity interval training (C-HIIT', 'CON', 'Different Exercise Training Intensities']","['modified Nordic Musculoskeletal Questionnaire and the Neuropathy Total Symptom Score-6 respectively', 'sensory function', 'Adverse events', 'Musculoskeletal and Neuropathic Pain', 'musculoskeletal pain intensity', 'neuropathy symptoms', 'adverse events', 'pain pressure thresholds', 'musculoskeletal and neuropathic pain', 'musculoskeletal pain']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",32.0,0.143575,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Cox', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Trishan', 'Initials': 'T', 'LastName': 'Gajanand', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Nicola W', 'Initials': 'NW', 'LastName': 'Burton', 'Affiliation': 'School of Applied Psychology, Griffith University, Mt Gravatt, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Brooke K', 'Initials': 'BK', 'LastName': 'Coombes', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Nathan, Queensland, Australia. Electronic address: b.coombes@griffith.edu.au.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108168']
108,32360596,What factors modify the effect of monthly bolus dose vitamin D supplementation on 25-hydroxyvitamin D concentrations?,"The increasing use of vitamin D supplements has stimulated interest in identifying factors that may modify the effect of supplementation on circulating 25-hydroxyvitamin D (25(OH)D) concentrations. Such information is of potential interest to researchers, clinicians and patients when deciding on bolus dose of vitamin D supplementation. We carried out a large randomized controlled trial of 5110 adults aged 50-84 years, of European/Other (84%), Polynesian (11%) and Asian (5%) ethnicity, to whom we gave a standard dose of vitamin D 3  supplements (200,000 IU initially, then 100,000 IU monthly) which was taken with high adherence. All participants provided a baseline blood sample, and follow-up blood samples were collected at 6 months and annually for 3 years in a random sample of 441 participants, and also at 2 years in 413 participants enrolled in a bone density sub-study. Serum 25(OH)D was measured by LC/MSMS. Mixed model analyses were carried out on all 854 participants providing follow-up blood samples in multivariable models that included age, sex, ethnicity, body mass index (kg/m 2 ), tobacco smoking, alcohol intake, physical activity, sun exposure, season, medical prescription of high-dose vitamin D 3  (Cal.D.Forte tablets), asthma/COPD and the study treatment (vitamin D or placebo). The adjusted mean difference in 25(OH)D in the follow-up points between vitamin D supplementation and placebo groups was inversely related (all p for interaction <0.05) to baseline 25(OH)D, BMI, and hours of sun exposure, and higher in females, elders, and those with high frequency of alcohol, medical prescription of vitamin D, and asthma/COPD. The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33). In summary, these data show that vitamin D status, BMI, sun exposure hours, sex and asthma/COPD modify the 25(OH)D response to vitamin D supplementation. By contrast, ethnicity, tobacco smoking, and vigorous activity do not.",2020,"The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33).","['5,110 adults aged 50-84 years, of European/Other (84%), Polynesian (11%) and Asian (5%) ethnicity', 'All participants provided a baseline blood sample, and follow-up blood samples were collected at 6 months and annually for 3 years in a random sample of 441 participants, and also at 2 years in 413 participants enrolled in a bone density sub-study', '854 participants providing follow-up blood samples in multivariable models that included age, sex, ethnicity, body mass index (kg/m 2 ), tobacco smoking, alcohol intake, physical activity, sun exposure, season, medical prescription of high-dose vitamin D 3  (Cal']","['vitamin D supplements', 'vitamin D 3  supplements', 'vitamin D or placebo', 'vitamin D supplementation', 'placebo']","['vigorous activity', 'circulating 25-hydroxyvitamin D (25(OH)D) concentrations', 'baseline 25(OH)D, BMI, and hours of sun exposure', 'Serum 25(OH)D', '25-hydroxyvitamin D concentrations', 'vitamin D status, BMI, sun exposure hours, sex and asthma/COPD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0240790', 'cui_str': 'Polynesians'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]","[{'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",5110.0,0.281124,"The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33).","[{'ForeName': 'Zhenqiang', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Beros', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Sluyter', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Waayer', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlene M M', 'Initials': 'CMM', 'LastName': 'Lawes', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Les', 'Initials': 'L', 'LastName': 'Toop', 'Affiliation': 'Department of Public Health & General Practice, The University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Kay-Tee', 'Initials': 'KT', 'LastName': 'Khaw', 'Affiliation': 'Department of Public Health, University of Cambridge, Cambridge, England, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand. Electronic address: r.scragg@auckland.ac.nz.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105687']
109,30862961,Differences in patient characteristics and care practices between two trials of therapeutic hypothermia.,"BACKGROUND


The Induced Hypothermia (IH) and Optimizing Cooling (OC) trials for hypoxic-ischemic encephalopathy (HIE) had similar inclusion criteria. The rate of death/moderate-severe disability differed for the subgroups treated with therapeutic hypothermia (TH) at 33.5 °C for 72 h (44% vs. 29%, unadjusted p = 0.03). We aimed to evaluate differences in patient characteristics and care practices between the trials.
METHODS


We compared pre/post-randomization characteristics and care practices between IH and OC.
RESULTS


There were 208 patients in the IH trial, 102 cooled, and 364 in the OC trial, 95 cooled to 33.5 °C for 72 h. In OC, neonates were less ill, fewer had severe HIE, and the majority were cooled prior to randomization. Differences between IH and OC were observed in the adjusted difference in the lowest PCO 2  (+3.08 mmHg, p = 0.005) and highest PO 2  (-82.7 mmHg, p < 0.001). In OC, compared to IH, the adjusted relative risk (RR) of exposure to anticonvulsant prior to randomization was decreased (RR 0.58, (0.40-0.85), p = 0.005) and there was increased risk of exposure during cooling to sedatives/analgesia (RR 1.86 (1.21-2.86), p = 0.005).
CONCLUSION


Despite similar inclusion criteria, there were differences in patient characteristics and care practices between trials. Change in care practices over time should be considered when planning future neuroprotective trials.",2019,"The rate of death/moderate-severe disability differed for the subgroups treated with therapeutic hypothermia (TH) at 33.5 °C for 72 h (44% vs. 29%, unadjusted p = 0.03).","['208 patients in the IH trial, 102 cooled, and 364 in the OC trial, 95 cooled to 33.5\u2009°C for 72\u2009h']",['Induced Hypothermia (IH) and Optimizing Cooling (OC'],"['IH and OC', 'adjusted relative risk (RR) of exposure to anticonvulsant prior to randomization', 'risk of exposure during cooling to sedatives/analgesia', 'rate of death/moderate-severe disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0003286', 'cui_str': 'Anticonvulsant'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.205879,"The rate of death/moderate-severe disability differed for the subgroups treated with therapeutic hypothermia (TH) at 33.5 °C for 72 h (44% vs. 29%, unadjusted p = 0.03).","[{'ForeName': 'Sonia L', 'Initials': 'SL', 'LastName': 'Bonifacio', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA. soniab1@stanford.edu.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'McDonald', 'Affiliation': 'National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Valerie Y', 'Initials': 'VY', 'LastName': 'Chock', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Wusthoff', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Hintz', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Abbot R', 'Initials': 'AR', 'LastName': 'Laptook', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Brown University, Providence, RI, USA.'}, {'ForeName': 'Seetha', 'Initials': 'S', 'LastName': 'Shankara', 'Affiliation': 'Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Krisa P', 'Initials': 'KP', 'LastName': 'Van Meurs', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Palo Alto, CA, USA.'}]",Pediatric research,['10.1038/s41390-019-0371-2']
110,32379608,The Impact of Childhood Maltreatment on Long-Term Outcomes in Disorder-Specific vs. Nonspecific Psychotherapy for Chronic Depression.,"BACKGROUND


Childhood maltreatment (CM) predicted poorer outcomes in acute depression treatment with CBT, IPT and Supportive Psychotherapy (SP). The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) fared well in patients with chronic depression and CM during acute treatment, yet there is a considerable lack of empirical evidence for long-term outcomes.
METHODS


We analyzed one and two-year follow-up data of 268 patients randomized to 24 sessions (20 weeks) of acute and 8 sessions (28 weeks) of extended treatment with CBASP or SP. Primary outcome was the number of well weeks as measured by the Longitudinal Interval Follow-Up Evaluation Interview (LIFE). Secondary outcomes included self- and clinician-rated depression symptoms. We investigated this moderating effect for any CM and for specific subtypes of CM.
RESULTS


Intent-to-treat analyses revealed that the presence of CM did not significantly moderate long-term effects of CBASP compared to SP. The analysis of trauma subtypes revealed that patients with childhood emotional abuse had statistically significant worse outcomes than patients without (main effect, p=.015) and that the advantage of CBASP over SP was larger in patients with childhood emotional abuse than in patients without (interaction effect, p=.045) after 1 year. No significant effects were found for other trauma subtypes.
LIMITATIONS


The measurement of CM was limited to retrospective self-assessment.
CONCLUSIONS


The presence of CM did not significantly moderate long-term treatment effects of CBASP compared to SP. When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.",2020,"When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.","['Disorder-Specific vs. Nonspecific Psychotherapy for Chronic Depression', 'patients with chronic depression and CM during acute treatment']","['CBT, IPT and Supportive Psychotherapy (SP', 'Psychotherapy (CBASP', 'CBASP', 'CBASP or SP']","['number of well weeks as measured by the Longitudinal Interval Follow-Up Evaluation Interview (LIFE', 'self- and clinician-rated depression symptoms']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",268.0,0.144678,"When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bausch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. Electronic address: paul.bausch@gmx.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fangmeier', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Meister', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Elsaeßer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Zobel', 'Affiliation': 'Psychology School at the Fresenius University of Applied Sciences Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, Eberhard Karls University Tübingen, Tübingen, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.164']
111,32356074,"A Randomized, Controlled, Pilot Study of CPAP for Patients with Chronic Cough and Obstructive Sleep Apnea.","BACKGROUND


An association between chronic cough and obstructive sleep apnea (OSA) has been reported in prior studies with resolution or improvement in cough after continuous positive airway pressure (CPAP) therapy. Controlled studies of the benefit of CPAP on cough-quality of life measures have not been conducted.
RESEARCH QUESTION


Does CPAP therapy for OSA improve cough in patients with chronic unexplained cough?
STUDY DESIGN AND METHODS


Patients with unexplained chronic cough (> 2 months duration of cough) and OSA were randomized to receive either CPAP or sham CPAP therapy for 6 weeks. The primary end point was the change in health status assessed with the Leicester Cough Questionnaire (LCQ) in patients treated with CPAP vs. sham CPAP. Secondary end points were changes in exhaled breath condensate markers of airway inflammation (interleukin-6, nitrite/nitrates, hydrogen peroxide and 8-isoprostanes).
RESULTS


A total of 22 patients with chronic unexplained cough and OSA were randomized of whom18 completed 6 weeks of treatments with either CPAP or sham CPAP. The CPAP vs. sham CPAP-treated group were comparable in terms of sex distribution, body mass index, and OSA severity. Following CPAP therapy, there was a significantly greater improvement in total LCQ scores as compared to those treated with sham therapy (ANCOVA p value 0.016). No significant differences were noted in the exhaled breath condensate marker changes between CPAP-treated vs. sham CPAP-treated groups.
CONCLUSION


Treatment of comorbid OSA in patients with chronic cough improved cough quality of life measures following treatment of OSA with CPAP in this pilot study. Larger studies to understand this association and unravel mechanisms of CPAP benefit in chronic cough need to be undertaken. Clinical Trial Registration NCT03172130.",2020,"Following CPAP therapy, there was a significantly greater improvement in total LCQ scores as compared to those treated with sham therapy (ANCOVA p value 0.016).","['Patients with Chronic Cough and Obstructive Sleep Apnea', 'patients with chronic unexplained cough', 'chronic cough and obstructive sleep apnea (OSA', 'patients with chronic cough', '22 patients with chronic unexplained cough and OSA', 'Patients with unexplained chronic cough (>\u20092\xa0months duration of cough) and OSA']","['CPAP vs. sham CPAP', 'CPAP', 'CPAP or sham CPAP', 'CPAP or sham CPAP therapy', 'CPAP therapy']","['change in health status assessed with the Leicester Cough Questionnaire (LCQ', 'exhaled breath condensate markers of airway inflammation (interleukin-6, nitrite/nitrates, hydrogen peroxide and 8-isoprostanes', 'exhaled breath condensate marker changes', 'total LCQ scores', 'cough quality of life measures', 'sex distribution, body mass index, and OSA severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1277590', 'cui_str': 'Unexplained cough'}, {'cui': 'C4552485', 'cui_str': 'Unexplained chronic cough'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1629517', 'cui_str': 'Exhaled breath condensate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036878', 'cui_str': 'Sex Distribution'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",22.0,0.0751761,"Following CPAP therapy, there was a significantly greater improvement in total LCQ scores as compared to those treated with sham therapy (ANCOVA p value 0.016).","[{'ForeName': 'Krishna M', 'Initials': 'KM', 'LastName': 'Sundar', 'Affiliation': 'Department of Medicine, University of Utah, Salt Lake City, Utah, USA. krishna.sundar@hsc.utah.edu.'}, {'ForeName': 'Alika M', 'Initials': 'AM', 'LastName': 'Willis', 'Affiliation': 'Department of Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Sleep-Wake Center, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'Family & Preventive Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Jay P', 'Initials': 'JP', 'LastName': 'Kitt', 'Affiliation': 'Department of Biomedical Informatics and Department of Chemistry, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Surinder S', 'Initials': 'SS', 'LastName': 'Birring', 'Affiliation': ""Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}]",Lung,['10.1007/s00408-020-00354-1']
112,32369281,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Dalerba', 'Affiliation': 'Columbia University, New York, NY pdd2109@columbia.edu.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Levin', 'Affiliation': 'Columbia University, New York, NY pdd2109@columbia.edu.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Thompson', 'Affiliation': 'Columbia University, New York, NY pdd2109@columbia.edu.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
113,32369283,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Havlichek', 'Affiliation': 'Michigan State University, East Lansing, MI havliche@msu.edu.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
114,32369284,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corrao', 'Affiliation': 'University of Palermo School of Medicine, Palermo, Italy s.corrao@tiscali.it.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Natoli', 'Affiliation': 'ARNAS Civico Di Cristina Benfratelli, Palermo, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cacopardo', 'Affiliation': 'University of Catania School of Medicine, Catania, Italy.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
115,32369285,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Carmona-Bayonas', 'Affiliation': 'Hospital Universitario Morales Meseguer, Murcia, Spain alberto.carmonabayonas@gmail.com.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Jimenez-Fonseca', 'Affiliation': 'Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Castañón', 'Affiliation': 'Clínica Universidad de Navarra, Madrid, Spain.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
116,32369282,A Trial of Lopinavir-Ritonavir in Covid-19.,,2020,,['Covid-19'],['Lopinavir-Ritonavir'],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]",[],,0.0535202,,"[{'ForeName': 'Kurt M', 'Initials': 'KM', 'LastName': 'Kunz', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA kkunz@sas.upenn.edu.'}]",The New England journal of medicine,['10.1056/NEJMc2008043']
117,32363972,Pre-infusion single-dose mesenchymal stem cells promote platelet engraftment and decrease severe acute graft versus host disease without relapse in haploidentical peripheral blood stem cell transplantation.,"BACKGROUND


Mesenchymal stem cells (MSCs) may be used to treat steroid-refractory graft versus host disease (GVHD). However, the effects of MSCs in haploidentical peripheral blood stem cell transplantation (haplo-PBSCT) have not been confirmed in randomized studies.
METHODS


We conducted a randomized clinical study to investigate the effects of pre-infusion (1 × 10 6  cells/kg) MSCs on hematopoietic recovery, Epstein-Barr and cytomegalovirus infection, GVHD, and relapse in patients undergoing haplo-PBSCT. Fifty patients with acute leukemia or myelodysplastic syndrome were randomly divided into an MSC group administered 1 × 10 6  MSCs/kg 4 to 6 hours before infusion of peripheral stem cells and a control group without MSCs.
RESULTS


Mean platelet engraftment time was significantly faster in the MSC compared with the control group (12.28 vs 13.29 days). The mean neutrophil engraftment time was comparable in both groups (10.76 ± 2.40 vs. 10.29 ± 1.72 days). Grade II or above acute GVHD was significantly decreased in the MSC compared with the control group (12% vs. 36%). There were no significant differences in relapse rate or overall survival between the groups.
CONCLUSION


These results suggest that pre-infusion single-dose MSCs promote platelet engraftment and decrease severe acute GVHD without increasing relapse rate.",2020,Grade II or above acute GVHD was significantly decreased in the MSC compared with the control group (12% vs. 36%).,"['haploidentical peripheral blood stem cell transplantation', 'patients undergoing haplo-PBSCT', 'Fifty patients with acute leukemia or myelodysplastic syndrome']","['MSC group administered 1\u2009×\u200910 6  MSCs/kg 4 to 6 hours before infusion of peripheral stem cells and a control group without MSCs', 'pre-infusion (1\u2009×\u200910 6  cells/kg) MSCs', 'MSC', 'MSCs']","['Mean platelet engraftment time', 'relapse rate or overall survival', 'Grade II or above acute GVHD', 'mean neutrophil engraftment time', 'hematopoietic recovery, Epstein-Barr and cytomegalovirus infection, GVHD, and relapse']","[{'cui': 'C0242602', 'cui_str': 'Peripheral blood stem cell graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018591', 'cui_str': 'Haplotypes'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}]","[{'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1518999', 'cui_str': 'Peripheral blood stem cell'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}]",50.0,0.0659951,Grade II or above acute GVHD was significantly decreased in the MSC compared with the control group (12% vs. 36%).,"[{'ForeName': 'Xiaoning', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'He', 'Affiliation': ""Department of Hematology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}]",The Journal of international medical research,['10.1177/0300060520920438']
118,32360042,Survival probability of zirconia-reinforced lithium silicate ceramic: Effect of surface condition and fatigue test load profile.,"OBJECTIVES


The present investigation evaluated the step stress accelerated test (SSALT) load profiles on the survival probability of a glass ceramic under two surface conditions (polished or roughened).
METHODS


Suprinity-ZLS blocks (Vita Zhanfabrik) were shaped into cylinders, cut in a sawing machine, and crystalized according to the manufacturer's instructions. 60 discs were obtained (Ø=12mm, thickness=1.2mm) and randomly assigned into two surface conditions: ""p"" polished surface (400-1200-grit SiC papers), and ""r"" roughened surface (200-grit SiC papers). Profilometry was performed in all discs to evaluate average surface roughness prior to flexural fatigue strength testing. 3 discs of each group were submitted to biaxial flexural strength in an universal testing machine (0.5mm/min) and the mean load to failure (N) was calculated to determine SSALT profiles. 27 specimens per surface condition were assigned into three profiles - Mild (n=9), Moderate (n=9), and Aggressive (n=9), and submitted to the fatigue test (60-320N, 140,000 cycles at 1.4Hz). The results were analyzed using the Kaplan-Meier and Wilcoxon tests (5%), 2-way ANOVA and Tukey test (α=5%).
RESULTS


Kaplan-Meier and generalized Wilcoxon showed (P=0.002) that polished groups showed higher survival probability than roughened condition (P<0.05). A rough internal surface impacted deleteriously on the fatigue strength and reliability of ZLS ceramic. Both surface conditions were more sensitive to the aggressive profile than the other profiles, even worst for the roughened group. Regardless the load profile, 0% survival probability was observed at 384MPa for polished condition. While for roughened, aggressive tested specimens did not survived 147MPa followed by moderate at 312MPa and mild at 384MPa. The failure modes showed fracture marks originating from superficial grooves for both surface conditions.
SIGNIFICANCE


Polished specimens are sensitive to the load profile variation, confirming the effect of surface morphology on the fatigue results.",2020,Wilcoxon showed (P=0.002) that polished groups showed higher survival probability than roughened condition (P<0.05).,"['Suprinity-ZLS blocks (Vita Zhanfabrik', '27 specimens per surface condition were assigned into three profiles - Mild (n=9), Moderate (n=9), and Aggressive (n=9']","['Wilcoxon', 'zirconia-reinforced lithium silicate ceramic']","['fatigue strength and reliability of ZLS ceramic', 'Survival probability', 'Kaplan-Meier and Wilcoxon tests', 'survival probability', 'biaxial flexural strength']","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0373745', 'cui_str': 'Vitamin A measurement'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0086983', 'cui_str': 'Silicate salt'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}]",60.0,0.0177578,Wilcoxon showed (P=0.002) that polished groups showed higher survival probability than roughened condition (P<0.05).,"[{'ForeName': 'Amanda Maria de Oliveira', 'Initials': 'AMO', 'LastName': 'Dal Piva', 'Affiliation': 'PhD Graduate Program in Restorative Dentistry, São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, SP, Brazil; Department of Dental Materials Science, Academic Centre for Dentistry Amsterdam (ACTA), Universiteit van Amsterdam and Vrije Universiteit, The Netherlands. Electronic address: amodalpiva@gmail.com.'}, {'ForeName': 'João Paulo Mendes', 'Initials': 'JPM', 'LastName': 'Tribst', 'Affiliation': 'PhD Graduate Program in Restorative Dentistry, São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, SP, Brazil; Department of Dental Materials Science, Academic Centre for Dentistry Amsterdam (ACTA), Universiteit van Amsterdam and Vrije Universiteit, The Netherlands. Electronic address: joao.tribst@unesp.br.'}, {'ForeName': 'Andressa Borin', 'Initials': 'AB', 'LastName': 'Venturini', 'Affiliation': 'PhD Graduate Program in Oral Science (Prosthodontics Unit), Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: andressa.venturini@hotmail.com.'}, {'ForeName': 'Lilian Costa', 'Initials': 'LC', 'LastName': 'Anami', 'Affiliation': 'Department of Prosthodontics, Santo Amaro University, São Paulo, Brazil. Electronic address: lianami@gmail.com.'}, {'ForeName': 'Estevam Augusto', 'Initials': 'EA', 'LastName': 'Bonfante', 'Affiliation': 'Department of Prosthodontics and Periodontology, University of São Paulo, Bauru School of Dentistry, Brazil. Electronic address: estevamab@gmail.com.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Bottino', 'Affiliation': 'PhD Graduate Program in Restorative Dentistry, São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, SP, Brazil. Electronic address: mmbottino@uol.com.br.'}, {'ForeName': 'Cornelis Johannes', 'Initials': 'CJ', 'LastName': 'Kleverlaan', 'Affiliation': 'Department of Dental Materials Science, Academic Centre for Dentistry Amsterdam (ACTA), Universiteit van Amsterdam and Vrije Universiteit, The Netherlands. Electronic address: c.kleverlaan@acta.nl.'}]",Dental materials : official publication of the Academy of Dental Materials,['10.1016/j.dental.2020.03.029']
119,32371183,Optimization of CT windowing for diagnosing invasiveness of adenocarcinoma presenting as sub-solid nodules.,"PURPOSE


To evaluate the optimal window setting to diagnose the invasiveness of lung adenocarcinoma in sub-solid nodules (SSNs).
METHODS


We retrospectively included 437 SSNs and randomly divided them 3:1 into a training group (327) and a testing group (110). The presence of a solid component was regarded as indicator of invasiveness. At fixed window level (WL) of 35 Hounsfield Units (HU), two readers adjusted the window width (WW) in the training group and recorded once a solid component appeared or disappeared on CT images acquired at 120 kVp. The optimal WW cut-off value to differentiate between invasive and pre-invasive lesions, based on the receiver operating characteristic (ROC) curve, was defined as ""core"" WW. The diagnostic performances of the mediastinal window setting (WW/WL, 350/35 HU) and core window setting were then compared in the testing group.
RESULTS


Of the 437 SSNs, 88 were pre-invasive [17 atypical adenomatous hyperplasia (AAH) and 71 adenocarcinoma in situ (AIS)], 349 were invasive [233 minimally invasive adenocarcinoma (MIA), 116 invasive adenocarcinoma (IA)]. In training group, the core WW of 1175 HU was the optimal cut-off to detect solid components of SSNs (AUC:0.79). In testing group, the sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness were 49.4%, 90.5%, 95.7%, 29.7%, and 57.3% for mediastinal window setting, and 87.6%, 76.2%, 91.6%, 76.2%, and 85.5% for core window setting.
CONCLUSION


At 120 kVp, core window setting (WW/WL, 1175/35 HU) outperformed the traditional mediastinal window setting to diagnose the invasiveness of SSNs.",2020,"In testing group, the sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness were 49.4%, 90.5%, 95.7%, 29.7%, and 57.3% for mediastinal window setting, and 87.6%, 76.2%, 91.6%, 76.2%, and 85.5% for core window setting.
","['lung adenocarcinoma in sub-solid nodules (SSNs', 'Of the 437 SSNs, 88 were pre-invasive [17 atypical adenomatous hyperplasia (AAH) and 71 adenocarcinoma in situ (AIS', '437 SSNs', ' 349 were invasive [233 minimally invasive adenocarcinoma (MIA), 116 invasive adenocarcinoma (IA']",['CT'],"['sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness']","[{'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0334001', 'cui_str': 'Atypical glandular hyperplasia'}, {'cui': 'C0334000', 'cui_str': 'Glandular hyperplasia'}, {'cui': 'C0334276', 'cui_str': 'Adenocarcinoma in situ'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C4517541', 'cui_str': '116'}]",[],"[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1301821', 'cui_str': 'Social security number'}, {'cui': 'C1301757', 'cui_str': 'Invasiveness'}]",233.0,0.0224966,"In testing group, the sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness were 49.4%, 90.5%, 95.7%, 29.7%, and 57.3% for mediastinal window setting, and 87.6%, 76.2%, 91.6%, 76.2%, and 85.5% for core window setting.
","[{'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China; University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.""}, {'ForeName': 'Shuxuan', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China.""}, {'ForeName': 'Marjolein A', 'Initials': 'MA', 'LastName': 'Heuvelmans', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands; Medisch Spectrum Twente, Department of Pulmonology, Enschede, the Netherlands.'}, {'ForeName': 'Daiwei', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.'}, {'ForeName': 'Yingru', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China.""}, {'ForeName': 'Harry J M', 'Initials': 'HJM', 'LastName': 'Groen', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands.'}, {'ForeName': 'Monique D', 'Initials': 'MD', 'LastName': 'Dorrius', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Oudkerk', 'Affiliation': 'Institute for Diagnostic Accuracy (iDNA) BV, Groningen, the Netherlands; University of Groningen, Faculty of Medical Sciences, Groningen, the Netherlands.'}, {'ForeName': 'Geertruida H', 'Initials': 'GH', 'LastName': 'de Bock', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands.'}, {'ForeName': 'Rozemarijn', 'Initials': 'R', 'LastName': 'Vliegenthart', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.'}, {'ForeName': 'Zhaoxiang', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China. Electronic address: yezhaoxiang@163.com.""}]",European journal of radiology,['10.1016/j.ejrad.2020.108981']
120,32371199,Clinical assessment of AF pattern is poorly correlated with AF burden and post ablation outcomes: A CIRCA-DOSE sub-study.,"BACKGROUND


Contemporary guidelines recommend that atrial fibrillation (AF) be classified into paroxysmal and persistent AF based on clinical assessment, with these categorizations forming the basis of therapeutic recommendations. While pragmatic, clinical assessment may introduce misclassification errors, which may impact treatment decisions. We sought to determine the relationship between AF classification, baseline AF burden, and post-ablation arrhythmia outcomes.
DESIGN


The current study is a sub-analysis of a prospective, parallel-group, multicenter, single-blinded randomized clinical trial. All 346 patients enrolled in CIRCA-DOSE received an implantable cardiac monitor a median of 72 days prior to ablation. AF was classified as low burden paroxysmal, high burden paroxysmal, or persistent based on clinical assessment prior to device implantation. Prior to ablation patients were re-classified using the same definitions based on device monitoring data. Correlation between classifications, AF burden, and post-ablation arrhythmia outcomes were assessed.
RESULTS


There was poor agreement between clinical and device-based AF classification (Cohen's kappa: 0.192). AF classification derived from pre-ablation continuous monitoring reflected baseline and post-ablation AF burden with greater accuracy and with less overlap between the AF classes (P < 0.01 for all categorical comparisons). Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence).
CONCLUSIONS


Classification of AF pattern based on pre-ablation continuous cardiac rhythm monitoring better predicted AF burden and freedom from recurrent AF post ablation. Despite the use of standardized definitions, classification of AF based on clinical assessment did not predict baseline AF burden, post ablation AF burden, or freedom from recurrent AF post ablation.
TRIAL REGISTRATION


ClinicalTrials.govNCT01913522.",2020,"Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence).
",['346 patients enrolled in'],"['implantable cardiac monitor', 'CIRCA-DOSE']","['AF burden, and post-ablation arrhythmia outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3879681', 'cui_str': 'Implantable cardiac monitor'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",346.0,0.0501133,"Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence).
","[{'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada; Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada. Electronic address: Jason.andrade@vch.ca.'}, {'ForeName': 'Robert R J', 'Initials': 'RRJ', 'LastName': 'Yao', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada.'}, {'ForeName': 'Nathaniel M', 'Initials': 'NM', 'LastName': 'Hawkins', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Rizkallah', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Umjeet', 'Initials': 'U', 'LastName': 'Jolly', 'Affiliation': ""St. Mary's Hospital, Kitchener, Canada.""}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'St. Boniface Hospital, Winnipeg, Canada.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Raymond', 'Affiliation': 'Centre Hospitalier Universitaire de Montreal, Université de Montréal, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McKinney', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Steinberg', 'Affiliation': 'Department of Medicine, Université Laval, Quebec, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ha', 'Affiliation': 'Toronto General Hospital, University of Toronto, Toront006F, Canada.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Ramanathan', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Luong', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Glover', 'Affiliation': 'Sunnybrook Hospital, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Center, Newmarket, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of electrocardiology,['10.1016/j.jelectrocard.2020.03.008']
121,32361367,Feasibility of a text-based reduction intervention in helping rural and underserved smokeless tobacco users quit.,"INTRODUCTION


Smokeless tobacco (ST) use significantly affects morbidity and mortality and remains disproportionally prevalent in rural and medically underserved communities. Few programs exist for rural smokeless tobacco users. Text-based interventions may increase the reach of cessation interventions; yet, none has tested them in ST users. We evaluated the feasibility, acceptability, and preliminary efficacy of a text-based Scheduled Gradual Reduction (SGR) intervention in rural and underserved ST users.
METHODS


ST users were randomized in 2:1 fashion to the SGR group (N = 65), a text-based reduction program plus text-based support counseling messages or text-based support messages only group (N = 33). We surveyed participants at 30-days post intervention initiation to assess feasibility and acceptability and examined self-report 7-day point prevalence cessation at 30-days and 6-months post intervention initiation in the two arms.
RESULTS


We achieved benchmarks for feasibility and acceptability. Among the SGR participants 51% (n = 48) reported that intervention was useful in helping them quit, 83% (n = 48) indicated that they would recommend the intervention to a friend. Over 95% (n = 39) of SGR participants said that they read all alert texts. The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect). However, the quit rate at 6-months was 21% (p = 0.9703) for both groups.
CONCLUSIONS


A text-based intervention was feasible and acceptable among underserved ST users. SGR helped promote short-term cessation. The text-based interventions both had long-term efficacy. Given that text-based interventions have the potential to increase reach in underserved ST users, further testing is warranted.",2020,"The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect).","['helping rural and underserved smokeless tobacco users quit', 'rural and underserved ST users', 'rural and medically underserved communities', 'rural smokeless tobacco users', 'ST users']","['text-based Scheduled Gradual Reduction (SGR) intervention', 'text-based reduction intervention', 'Smokeless tobacco (ST', 'text-based reduction program plus text-based support counseling messages or text-based support messages only group', 'SGR']","['feasibility and acceptability and examined self-report 7-day point prevalence cessation', 'feasibility and acceptability', 'quit rate']","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",51.0,0.0567251,"The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect).","[{'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States; Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States. Electronic address: devon.noonan@duke.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States; Duke University School of Medicine, Department of Community and Family Medicine, 2424 Erwin Rd, Suite 602, Durham, NC 27710, United States.'}, {'ForeName': 'Kellen', 'Initials': 'K', 'LastName': 'Peter', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Cherie', 'Initials': 'C', 'LastName': 'Conley', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Leigh Ann', 'Initials': 'LA', 'LastName': 'Simmons', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States; University of California, Davis, Department of Human Ecology, 301 Shields Avenue, Davis, CA 95616, United States.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Dr, Eugene, OR 97403, United States.'}, {'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States; Duke University School of Medicine, Department of Pupulation Health Sciences, 2424 Erwin Road Suite 602, Durham, NC 27710, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106434']
122,32361414,Neural correlates of NOS1 ex1f-VNTR allelic variation in panic disorder and agoraphobia during fear conditioning and extinction in fMRI.,"Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior in animals. In humans, the short (S) allele of a functional promotor polymorphism of NOS1 (NOS1 ex1f-VNTR) has been shown to be associated with higher anxiety and altered fear conditioning in healthy subjects in the amygdala and hippocampus (AMY/HIPP). Here, we explore the role of NOS1 ex1f-VNTR as a pathophysiological correlate of panic disorder and agoraphobia (PD/AG). In a sub-sample of a multicenter cognitive behavioral therapy (CBT) randomized controlled trial in patients with PD/AG (n = 48: S/S-genotype n=15, S/L-genotype n=21, L/L-genotype n=12) and healthy control subjects, HS (n = 34: S/S-genotype n=7, S/L-genotype n=17, L/L-genotype=10), a differential fear conditioning and extinction fMRI-paradigm was used to investigate how NOS1 ex1f-VNTR genotypes are associated with differential neural activation in AMY/HIPP. Prior to CBT, L/L-allele carriers showed higher activation than S/S-allele carriers in AMY/HIPP. A genotype × diagnosis interaction revealed that the S-allele in HS was associated with a pronounced deactivation in AMY/HIPP, while patients showed contrary effects. The interaction of genotype × stimulus type (CS+, conditioned stimulus associated with an aversive stimulus vs. CS-, unassociated) showed effects on differential learning in AMY/HIPP. All effects were predominately found during extinction. Genotype associated effects in patients were not altered after CBT. Low statistical power due to small sample size in each subgroup is a major limitation. However, our findings provide first preliminary evidence for dysfunctional neural fear conditioning/extinction associated with NOS1 ex1f-VNTR genotype in the context of PD/AG, shedding new light on the complex interaction between genetic risk, current psychopathology and treatment-related effects.",2020,Genotype associated effects in patients were not altered after CBT.,"['n\xa0=\xa048', 'healthy subjects', 'animals', 'patients with PD/AG', 'panic disorder and agoraphobia during fear conditioning and extinction in fMRI']",['cognitive behavioral therapy (CBT'],['Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0669368', 'cui_str': 'Nitric Oxide Synthase, Type I'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0249077,Genotype associated effects in patients were not altered after CBT.,"[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Herterich', 'Affiliation': 'Clinical Chemistry and Laboratory Medicine, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102268']
123,32361667,Manipulating visual perspective for obsessional imagery and its impact on obsessive-compulsive symptoms in an analogue sample.,"Visual perspective may have an important role in the phenomenology of intrusive images relevant to psychological disorders such as obsessive-compulsive disorder (OCD). The aim of the current study was to examine the subjective and behavioural effects of manipulating visual perspective, to either field or observer, on intrusive images related to doubting and contamination concerns. One hundred and twelve undergraduate participants with high levels OCD symptoms were asked to identify and imagine an intrusive image related to either doubting or contamination concerns. We then randomly assigned them to re-visualise their image from either a field (first-person) or observer (third-person) visual perspective. Participants shifted towards using an observer perspective demonstrated a greater decrease on ratings of subjective measures of image-related distress, prospective likelihood of the image occurring, and urges to suppress the image, relative to those shifted to a field perspective. In addition, those in the observer perspective evidenced a greater decrease on behavioural indices relevant to OCD, such as reduced frequency of the intrusive image and decreased efforts to neutralise the image. We discuss implications for imagery in OCD.",2020,"Participants shifted towards using an observer perspective demonstrated a greater decrease on ratings of subjective measures of image-related distress, prospective likelihood of the image occurring, and urges to suppress the image, relative to those shifted to a field perspective.",['One hundred and twelve undergraduate participants with high levels OCD symptoms'],[],"['obsessive-compulsive symptoms', 'ratings of subjective measures of image-related distress']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],"[{'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",112.0,0.0318503,"Participants shifted towards using an observer perspective demonstrated a greater decrease on ratings of subjective measures of image-related distress, prospective likelihood of the image occurring, and urges to suppress the image, relative to those shifted to a field perspective.","[{'ForeName': 'Shiu F', 'Initials': 'SF', 'LastName': 'Wong', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, Canada.'}, {'ForeName': 'Derek A P', 'Initials': 'DAP', 'LastName': 'Hu', 'Affiliation': 'School of Psychology, UNSW Sydney, Kensington, Australia.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Grisham', 'Affiliation': 'School of Psychology, UNSW Sydney, Kensington, Australia. Electronic address: jessicag@unsw.edu.au.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102227']
124,32361668,Social comparison modulates coping with fear in virtual environments.,"Social comparison can guide adaptive behavior in fear-related situations. The aim of this study was to investigate the effects of social comparison standards on acute anxiety levels and phobic symptoms. The sample comprised 159 individuals (M age  = 23.4) with self-reported fear of flying (22.6 %) or fear of heights (77.4 %) who were randomly assigned to an upward assimilation (UA) manipulation, a downward assimilation (DA) manipulation, or a control condition (no manipulation of social comparison) and entered a fear-related scenario in virtual reality (i.e., flying in an airplane or walking in a tall building, respectively). Results revealed that individuals in the UA condition reported significantly attenuated increases in anxiety levels from pre-exposure to both during- and post-exposure relative to the control condition. The DA condition did not significantly differ from either condition regarding increases in acute anxiety levels from pre-exposure to either during or post-exposure. At post-assessment, participants in the UA condition also reported fewer phobic symptoms compared to both the DA and the control condition. Our results suggest that social comparison can indeed modulate coping with fearful situations. Future research needs to investigate the underlying processes of social comparison and the extent to which social comparison can facilitate treatment of anxiety disorders.",2020,The DA condition did not significantly differ from either condition regarding increases in acute anxiety levels from pre-exposure to either during or post-exposure.,['159 individuals (M age  = 23.4) with self-reported fear of flying (22.6 %) or fear of heights (77.4 %) who were randomly assigned to an'],"['social comparison standards', 'upward assimilation (UA) manipulation, a downward assimilation (DA) manipulation, or a control condition (no manipulation of social comparison) and entered a fear-related scenario in virtual reality (i.e., flying in an airplane or walking in a tall building, respectively']","['anxiety levels', 'phobic symptoms', 'acute anxiety levels', 'acute anxiety levels and phobic symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424184', 'cui_str': 'Fear of flying'}, {'cui': 'C0233701', 'cui_str': 'Fear of heights'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1282911', 'cui_str': 'Upward'}, {'cui': 'C1704301', 'cui_str': 'Assimilation, Cultural'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0205104', 'cui_str': 'Down'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0012578', 'cui_str': 'Order Diptera'}, {'cui': 'C0683901', 'cui_str': 'Airplanes'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.0117484,The DA condition did not significantly differ from either condition regarding increases in acute anxiety levels from pre-exposure to either during or post-exposure.,"[{'ForeName': 'Isabel L', 'Initials': 'IL', 'LastName': 'Kampmann', 'Affiliation': 'Institute of Psychology, Westfälische Wilhelms-University Münster, Fliednerstraße 21, 48149 Münster, Germany. Electronic address: i.kampmann@uni-muenster.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Institute of Psychology, Westfälische Wilhelms-University Münster, Fliednerstraße 21, 48149 Münster, Germany. Electronic address: t.meyer@uni-muenster.de.'}, {'ForeName': 'Nexhmedin', 'Initials': 'N', 'LastName': 'Morina', 'Affiliation': 'Institute of Psychology, Westfälische Wilhelms-University Münster, Fliednerstraße 21, 48149 Münster, Germany. Electronic address: morina@uni-muenster.de.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102226']
125,32361689,PECS II may reduce chronic pain after breast surgery: A propensity score based secondary analysis of the BREAST trial.,,2020,,['after breast surgery'],['PECS'],['chronic pain'],"[{'cui': 'C0851312', 'cui_str': 'Breast surgery'}]","[{'cui': 'C0055065', 'cui_str': 'CEP combination'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",,0.250447,,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'De Cassai', 'Affiliation': 'UOC Anesthesia and Intensive Care Unit, University Hospital of Padova, Padova, Italy. Electronic address: alessandro.decassai@aopd.veneto.it.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bonanno', 'Affiliation': 'Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, University of Padova, Padova, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Andreatta', 'Affiliation': 'Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, University of Padova, Padova, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Marchet', 'Affiliation': 'Day Surgery Multidisciplinare, Surgical Department, Azienda Ospedaliera Padova, Padova, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Barbieri', 'Affiliation': 'UOC Anesthesia and Intensive Care Unit, University Hospital of Padova, Padova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Feltracco', 'Affiliation': 'UOC Anesthesia and Intensive Care Unit, University Hospital of Padova, Padova, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Carron', 'Affiliation': 'Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, University of Padova, Padova, Italy.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109851']
126,32361032,Ethnicity moderates outcome in family focused treatment for pediatric obsessive compulsive disorder.,"OBJECTIVE


This study examined predictors and moderators of treatment outcome in a randomized controlled trial (RCT) comparing two active interventions for pediatric obsessive compulsive disorder that differed with respect to the focus and format of family intervention. We had a particular interest in the role of race/ethnicity in shaping outcomes given our relatively diverse sample composition and the limited prior work in this area.
METHOD


A total of 62 youths (Mean age = 12.71 years; 57 % male; 34 % non-white) were assigned to either a standard cognitive behavioral therapy (CBT) family intervention (ST) or to a tailored intervention designed for cases of OCD complicated by poor family functioning (Enhanced Family Therapy; ET). Treatment in both arms involved 12 sessions of exposure therapy; the family interventions differed. Predictor and moderator variables were chosen based on the extant literature.
RESULTS


Minority status did not predict outcome, suggesting that overall, white and non-white youth had comparable treatment response. Race/ethnicity did, however, moderate response with non-white youth faring better in the ET arm of the study. In particular, minority youth in ET had, on average, post-treatment CYBOCS scores consistent with clinical remission whereas their ST counterparts were left with symptoms considered moderately severe. There were no predictors of treatment outcome.
CONCLUSIONS


Minority status predicts poorer response to standard CBT across disorders, suggesting the need for possible treatment adaptations. The present findings highlight one avenue for matching patients to treatments that might optimize outcomes and underscore the value of family involvement in OCD treatment.",2020,"There were no predictors of treatment outcome.
","['pediatric obsessive compulsive disorder', '62 youths (Mean age\u2009=\u200912.71 years; 57 % male; 34 % non-white']",['standard cognitive behavioral therapy (CBT) family intervention (ST) or to a tailored intervention designed for cases of OCD complicated by poor family functioning (Enhanced Family Therapy; ET'],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0015618', 'cui_str': 'Family therapy'}]",[],62.0,0.0176714,"There were no predictors of treatment outcome.
","[{'ForeName': 'Tara S', 'Initials': 'TS', 'LastName': 'Peris', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States. Electronic address: tperis@mednet.ucla.edu.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Rozenman', 'Affiliation': 'University of Denver, United States.'}, {'ForeName': 'Sunhye', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': 'Pennsylvania State University, United States.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States.'}, {'ForeName': 'Hardian', 'Initials': 'H', 'LastName': 'Thamrin', 'Affiliation': 'University of Arizona, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102229']
127,32370684,Low volume high intensity interval training leads to improved asthma control in adults.,"Objective:  Regularly engaging in aerobic exercise is associated with improved asthma control and quality of life in adults with mild to moderate severity asthma. Previous intervention research has primarily employed moderate intensity continuous aerobic exercise protocols. As such, the impact of high intensity interval training (HIIT) on asthma control is poorly understood. Methods:  A six-week, low volume HIIT intervention (3 times/week, 20 min bouts) was conducted in adults with asthma ( n  = 20). Asthma control was assessed using the Asthma Control Questionnaire-7 (ACQ-7). Results:  ACQ-7 improved from pre to post-intervention (pre: 0.8 ± 0.6; post: 0.5 ± 0.4,  p  = 0.02, Cohens  d  = 0.5). In total, 7/20 (35%) participants experienced clinically meaningful improvements in ACQ-7. Conclusion:  A low-volume HIIT intervention led to statistically and clinically significant improvements in asthma control as well as improved exertional dyspnea and exercise enjoyment.",2020,Regularly engaging in aerobic exercise is associated with improved asthma control and quality of life in adults with mild to moderate severity asthma.,"['adults with mild to moderate severity asthma', 'adults with asthma (n\u2009=\u200920', 'adults']","['high intensity interval training (HIIT', 'aerobic exercise']","['ACQ-7', 'asthma control and quality of life', 'exertional dyspnea and exercise enjoyment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0581122', 'cui_str': 'Asthma severity'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]",,0.0241432,Regularly engaging in aerobic exercise is associated with improved asthma control and quality of life in adults with mild to moderate severity asthma.,"[{'ForeName': 'Carley', 'Initials': 'C', 'LastName': ""O'Neill"", 'Affiliation': 'Faculty of Health Science (Kinesiology), University of Ontario Institute of Technology, Oshawa, Canada.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Dogra', 'Affiliation': 'Faculty of Health Science (Kinesiology), University of Ontario Institute of Technology, Oshawa, Canada.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1766063']
128,32371518,Psychiatric hospital reform in low-income and middle-income countries Structured Individualised inTervention And Recovery (SITAR): a two-arm pragmatic randomised controlled trial study protocol.,"INTRODUCTION


Low-income and middle-income settings like India have large treatment gaps in mental healthcare. People with severe mental disorders face impediments to their clinical and functional recovery, and have large unmet needs. The infrastructure and standards of care are poor in colonial period psychiatric hospitals, with no clear pathways to discharge and successfully integrate recovered individuals into the community. Our aim is to study the impact of psychiatric hospital reform on individual patient outcomes in a psychiatric hospital in India.
METHODS AND ANALYSIS


Structured Individualised inTervention And Recovery (SITAR) is a two-arm pragmatic randomised controlled trial, focusing on patients aged 18-60 years with a hospital stay of 12-120 months and a primary diagnosis of psychosis. It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life. A computer-generated permuted block randomisation schedule will allocate recruited subjects to the two study arms. We aim to recruit 100 people into each trial arm. Baseline and outcome measures will be undertaken by trained researchers independent to the case managers providing the individual intervention. A health economic analysis will determine the costing of implementing the individually tailored recovery plan.
ETHICS AND DISSEMINATION


The study will provide answers to important questions around the nature and process of reforms in institutional care that promote recovery while being cognizant of protecting human rights, and dignity. Ethical approval for SITAR was obtained from a registered ethics committee in India (Institutional Ethics Committee VikasAnvesh Foundation, VAF/2018-19/012 dated 6 December 2018) and the University of Warwick's Biomedical and Scientific Research Ethics Committee (REGO-2019-2332, dated 21 March 2019), and registered on the Central Trial Registry of India (CTRI/2019/01/017267). Trial results will be published in accordance to CONSORT guidelines.",2020,"It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life.","['People with severe mental disorders', 'patients aged 18-60 years with a hospital stay of 12-120 months and a primary diagnosis of psychosis', '100 people into each trial arm', 'psychiatric hospital in India']",['Individualised inTervention'],"['disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.266412,"It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life.","[{'ForeName': 'Tasneem', 'Initials': 'T', 'LastName': 'Raja', 'Affiliation': 'Mental Health, Tata Trusts, Mumbai, India T.Raja@warwick.ac.uk.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Tuomainen', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Madan', 'Affiliation': 'Center for Health Economics, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Dipesh', 'Initials': 'D', 'LastName': 'Mistry', 'Affiliation': 'Warwick Cinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Department of Psychiatry, NIMHANS, Bangalore, Karnataka, India.'}, {'ForeName': 'Swaran', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Director, Centre for Mental Health and Wellbeing Research, Warwick Medical School, Coventry, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035753']
129,32375104,Effects of the chymase inhibitor fulacimstat on adverse cardiac remodeling after acute myocardial infarction-Results of the Chymase Inhibitor in Adverse Remodeling after Myocardial Infarction (CHIARA MIA) 2 trial.,"BACKGROUND


Adverse cardiac remodeling is a major risk factor for the development of post myocardial infarction (MI) heart failure (HF). This study investigates the effects of the chymase inhibitor fulacimstat on adverse cardiac remodeling after acute ST-segment-elevation myocardial infarction (STEMI).
METHODS


In this double-blind, randomized, placebo-controlled trial patients with first STEMI were eligible. To preferentially enrich patients at high risk of adverse remodeling, main inclusion criteria were a left-ventricular ejection fraction (LVEF) ≤45% and an infarct size >10% on day 5 to 9 post MI as measured by cardiac MRI. Patients were then randomized to 6 months treatment with either 25 mg fulacimstat (n = 54) or placebo (n = 53) twice daily on top of standard of care starting day 6 to 12 post MI. The changes in LVEF, LV end-diastolic volume index (LVEDVI), and LV end-systolic volume index (LVESVI) from baseline to 6 months were analyzed by a central blinded cardiac MRI core laboratory.
RESULTS


Fulacimstat was safe and well tolerated and achieved mean total trough concentrations that were approximately tenfold higher than those predicted to be required for minimal therapeutic activity. Comparable changes in LVEF (fulacimstat: 3.5% ± 5.4%, placebo: 4.0% ± 5.0%, P = .69), LVEDVI (fulacimstat: 7.3 ± 13.3 mL/m 2 , placebo: 5.1 ± 18.9 mL/m 2 , P = .54), and LVESVI (fulacimstat: 2.3 ± 11.2 mL/m 2 , placebo: 0.6 ± 14.8 mL/m 2 , P = .56) were observed in both treatment arms.
CONCLUSION


Fulacimstat was safe and well tolerated in patients with left-ventricular dysfunction (LVD) after first STEMI but had no effect on cardiac remodeling.",2020,"RESULTS


Fulacimstat was safe and well tolerated and achieved mean total trough concentrations that were approximately tenfold higher than those predicted to be required for minimal therapeutic activity.",['controlled trial patients with first STEMI were eligible'],"['chymase inhibitor fulacimstat', '25 mg fulacimstat (n\u202f=\u202f54) or placebo', 'placebo']","['safe and well tolerated and achieved mean total trough concentrations', 'safe and well tolerated', 'cardiac remodeling', 'adverse cardiac remodeling', 'LVEF, LV end-diastolic volume index (LVEDVI), and LV end-systolic volume index (LVESVI']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0055673', 'cui_str': 'Chymase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",,0.55485,"RESULTS


Fulacimstat was safe and well tolerated and achieved mean total trough concentrations that were approximately tenfold higher than those predicted to be required for minimal therapeutic activity.","[{'ForeName': 'Hans-Dirk', 'Initials': 'HD', 'LastName': 'Duengen', 'Affiliation': 'Department of Internal Medicine, Cardiology, Charité-Universitaetsmedizin, Berlin, Germany.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Kim', 'Affiliation': 'Duke Cardiovascular Magnetic Resonance Center, Duke University Medical Center, Durham, United States.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Zahger', 'Affiliation': 'Department of Cardiology, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Orvin', 'Affiliation': 'Rabin Medical Center - Beilinson Campus, Cardiology Division, Petah Tikva, Israel.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': 'Rabin Medical Center - Beilinson Campus, Cardiology Division, Petah Tikva, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Admon', 'Affiliation': 'Hadassah Hebrew University Hospital Ein Kerem, Heart Institute, Jerusalem, Israel.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Kettner', 'Affiliation': 'Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.'}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Shimony', 'Affiliation': 'Department of Cardiology, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Otto', 'Affiliation': 'Experimental Medicine Cardiovascular, Bayer AG, Wuppertal, Germany. Electronic address: christiane.otto@bayer.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Becka', 'Affiliation': 'Research and Clinical Sciences Statistics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Kanefendt', 'Affiliation': 'Clinical Pharmacokinetics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Andres Iniguez', 'Initials': 'AI', 'LastName': 'Romo', 'Affiliation': 'Hospital Alvaro Cunqueiro, Servicio de la Cardiologia, Vigo, Spain.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Hasin', 'Affiliation': 'Shaare Zedek Medical Center, Department of Cardiology, Jerusalem, Israel.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Ostadal', 'Affiliation': 'Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Gonzalo Calvo', 'Initials': 'GC', 'LastName': 'Rojas', 'Affiliation': 'Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Division of Cardiology, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.01.012']
130,32376293,Automatic regulation of the endotracheal tube cuff pressure with a portable elastomeric device. A randomised controlled study.,"BACKGROUND


Intermittent manual correction of the endotracheal tube cuff pressure (P cuff ) may delay the detection of underinflation (source of contaminated oropharyngeal content microaspiration) or overinflation (exposing to airway damage). Devices for automated continuous correction of P cuff  are appealing but some are inconvenient, expensive or even harmful. This prospective randomised controlled study tested whether the tracoe Smart Cuff Manager™ reduced the rate of patients undergoing≥1 episode of underinflation (P cuff <20 cmH 2 O), as compared with routine manual P cuff  correction. The rate of patients with≥1 overinflation episode (P cuff >30 cmH 2 O) and the incidence of under/overinflation were also compared.
METHODS


Patients with acute brain injury and likely to receive invasive mechanical ventilation for>48h were randomly allocated to receive, during 48h, automated P cuff  correction (combined with manual correction) or manual correction alone. P cuff  was measured with a dedicated manual manometer, at least every 8h.
RESULTS


Sixty patients were included and randomised (32 patients with manual and 28 with automated P cuff  correction) for 506 measurements of P cuff  (269 and 237, respectively). Automated correction of P cuff  was associated with a lower rate of patients with≥1 episode of underinflation (63% and 18%, respectively, P<0.001), a lower incidence of underinflation episodes (15% vs. 2%; P<0.001), a lower rate of manual corrections (77% vs. 58%; P<0.001). For overinflation, there were no significant between-groups differences (2% vs. 2%). The incidence of early respiratory infections was similar in both groups (29% vs. 25%, P=0.78).
CONCLUSIONS


The adjunction of continuous P cuff  control with the Tracoe Smart Cuff Manager™ to routine manual intermittent correction reduced the incidence of P cuff  underinflation episodes without provoking overinflation.
TRIAL REGISTRATION


ClinicalTrials NCT03330379. Registered 6 November 2017, https://clinicaltrials.gov/ct2/show/NCT03330379.",2020,"The incidence of early respiratory infections was similar in both groups (29% vs. 25%, p = 0.78).
","['Sixty patients were included and randomised (32 patients with manual and 28 with automated Pcuff correction) for 506 measurements of Pcuff (269 and 237, respectively', 'patients undergoing ≥ 1 episode of underinflation (Pcuff<20 cmH2O', 'Patients with acute brain injury and likely to receive invasive mechanical ventilation for > 48 h']","['automated Pcuff correction (combined with manual correction) or manual correction alone', 'endotracheal tube cuff pressure (Pcuff', 'Tracoe Smart Cuff ManagerTM', 'endotracheal tube cuff pressure with a portable elastomeric device']","['lower rate of manual corrections', 'Pcuff', 'incidence of early respiratory infections', 'underinflation episodes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0085742', 'cui_str': 'Acute Brain Injuries'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0180212', 'cui_str': 'Endotracheal tube cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",60.0,0.0808773,"The incidence of early respiratory infections was similar in both groups (29% vs. 25%, p = 0.78).
","[{'ForeName': 'Jérôme E', 'Initials': 'JE', 'LastName': 'Dauvergne', 'Affiliation': ""Service d'anesthésie-réanimation, hôpital Laënnec, centre hospitalier universitaire de Nantes, boulevard Jacques-Monod, Saint-Herblain, 44093 Nantes cedex 1, France. Electronic address: jerome.dauvergne@chu-nantes.fr.""}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Geffray', 'Affiliation': ""Service d'anesthésie-réanimation, Hôtel-Dieu, centre hospitalier universitaire, 44093, Nantes, France.""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': ""Service d'anesthésie-réanimation, Hôtel-Dieu, centre hospitalier universitaire, 44093, Nantes, France.""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Rozec', 'Affiliation': ""Service d'anesthésie-réanimation, hôpital Laënnec, centre hospitalier universitaire de Nantes, boulevard Jacques-Monod, Saint-Herblain, 44093 Nantes cedex 1, France.""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Lakhal', 'Affiliation': ""Service d'anesthésie-réanimation, hôpital Laënnec, centre hospitalier universitaire de Nantes, boulevard Jacques-Monod, Saint-Herblain, 44093 Nantes cedex 1, France. Electronic address: lakhal_karim@yahoo.fr.""}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.04.007']
131,32376347,A pragmatic randomized trial of cardiopulmonary resuscitation training for families of cardiac patients before hospital discharge using a mobile application.,"AIM OF THE STUDY


Since over 80% of sudden cardiac arrests occur in the home, cardiopulmonary resuscitation (CPR) training for family members of high-risk cardiac patients represents a promising intervention. The use of mobile application-based (mApp) CPR training may facilitate this approach, but evidence regarding its efficacy is lacking.
METHODS


We conducted a multicenter, pragmatic, cluster-randomized trial assessing CPR training for family members of cardiac patients. The interventions were mApp (video, no manikin) and VSI (video + manikin). CPR skills were evaluated 6-months post-training. We hypothesized that chest compression (CC) rate from training with an mApp would be no worse than 5 compressions per minute (CPM) lower compared to VSI.
RESULTS


From 01/2016 to 01/2018, we enrolled 1325 eligible participants (mean age 51.6 years, 68.2% female and 59.4% white). CPR skills were evaluated 6-months post-training in 541 participants (275 VSI, 266 mApp). Mean rate was 84.6 CPM (95% CI: 80.4, 88.6) in VSI, compared to 82.7 CPM (95% CI: 76.2, 89.1) in the mApp, and mean depth was 42.1 mm (95% CI: 40.3, 43.8) in VSI, compared to 38.9 mm (95% CI: 36.2, 41.6) in the mApp. After adjustment, the mean difference in CC rate was -2.3 CPM (95% CI -9.4, 4.8, p = 0.25, non-inferiority) and CC depth was -3.2 mm (95% CI -5.9, 0.1, p = 0.056).
CONCLUSION


In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality. Future work is required to understand additional approaches to improve CPR skill retention.
CLINICAL TRIAL REGISTRATION


URL: ClinicalTrials.gov, Identifier: NCT02548793.",2020,"In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality.","['1,325 eligible participants (mean age 51.6 years, 68.2% female and 59.4% white', 'family members of cardiac patients', 'family members of high-risk cardiac patients', 'families of cardiac patients before hospital discharge using a mobile application']","['CPR training', 'cardiopulmonary resuscitation (CPR) training', 'cardiopulmonary resuscitation training', 'mobile application-based (mApp) CPR training']","['CPR skills', 'CC rate', 'Mean rate']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",1325.0,0.173811,"In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality.","[{'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'Blewer', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University, Durham, NC, USA. Electronic address: Audrey.blewer@duke.edu.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Putt', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Shaun K', 'Initials': 'SK', 'LastName': 'McGovern', 'Affiliation': 'Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Murray', 'Affiliation': 'Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Leary', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Berg', 'Affiliation': ""Department of Anesthesiology and Critical Care; University of Pennsylvania, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Viera', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University, Durham, NC, USA.'}, {'ForeName': 'Raina M', 'Initials': 'RM', 'LastName': 'Merchant', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Vinay M', 'Initials': 'VM', 'LastName': 'Nadkarni', 'Affiliation': ""Department of Anesthesiology and Critical Care; University of Pennsylvania, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Abella', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Resuscitation,['10.1016/j.resuscitation.2020.04.026']
132,32383013,Preoperative antibiotic prophylaxis regimen in brain tumour surgery in Sweden: a quasi-experimental study.,"BACKGROUND


There has been varied clinical practice concerning antibiotic prophylaxis in patients undergoing craniotomy. In Sweden, both Cloxacillin and Cefuroxime have frequently been used. We aimed to study the clinical effectiveness of these two regimens.
METHODS


A quasi-experimental design was used. The sample consisted of 580 adult (> 18 years) patients operated 2012-2015, of which 375 received Cloxacillin (pre-intervention group) and 205 received Cefuroxime (intervention group). Primary endpoint was the incidence of surgical site infection (SSI) 12 months after surgery, while secondary endpoints were the need for reoperation due to SSI, the amount antibiotics used and the number of visits in the outpatient clinic related to SSI. A control group from another institution was reviewed to rule out clinical trial effects.
RESULTS


When analysed by intention to treat, the pre-intervention group had a significant higher incidence of SSI, 13.3% (50/375) vs 5.4% (11/205) in the intervention group (p < 0.01). A treatment per protocol analysis confirmed the result. The number of reoperations due to SSI were significantly reduced in the intervention group, 3.4% (7/205) vs 8.3% (31/375) (p = 0.02), as was the total antibiotic use (p = 0.03) and the number of visits in the outpatient clinic (p < 0.01). In the control group, the reoperation rate as result of SSI was lower (p = 0.02) prior to the opposite change from Cefuroxime to Cloxacillin, 1.8% (27/1529) vs 3.1% (43/1378).
CONCLUSION


In Sweden, Cefuroxime as prophylaxis in brain tumour surgery by craniotomy seems to be superior to Cloxacillin.",2020,"In the control group, the reoperation rate as result of SSI was lower (p = 0.02) prior to the opposite change from Cefuroxime to Cloxacillin, 1.8% (27/1529) vs 3.1% (43/1378).
","['patients undergoing craniotomy', '580 adult (>\u200918\xa0years) patients operated 2012-2015, of which 375 received', 'brain tumour surgery in Sweden']","['Cefuroxime', 'Preoperative antibiotic prophylaxis regimen', 'Cloxacillin', 'Cloxacillin (pre-intervention group) and 205 received Cefuroxime', 'Cloxacillin and Cefuroxime']","['number of reoperations due to SSI', 'incidence of SSI', 'total antibiotic use', 'incidence of surgical site infection (SSI', 'reoperation rate as result of SSI', 'number of visits in the outpatient clinic', 'need for reoperation due to SSI, the amount antibiotics used and the number of visits in the outpatient clinic related to SSI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0009077', 'cui_str': 'Cloxacillin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",580.0,0.0480861,"In the control group, the reoperation rate as result of SSI was lower (p = 0.02) prior to the opposite change from Cefuroxime to Cloxacillin, 1.8% (27/1529) vs 3.1% (43/1378).
","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Skyrman', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden. simon.skyrman@sll.se.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Bartek', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Haghighi', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Fornebo', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Skoglund', 'Affiliation': 'Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Asgeir Store', 'Initials': 'AS', 'LastName': 'Jakola', 'Affiliation': 'Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'von Vogelsang', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Förander', 'Affiliation': 'Department of Neurosurgery, Karolinska University Hospital, 171 76, Stockholm, Sweden.'}]",Acta neurochirurgica,['10.1007/s00701-020-04309-6']
133,32380445,Intermittent theta-burst stimulation moderates interaction between increment of N-Acetyl-Aspartate in anterior cingulate and improvement of unipolar depression.,"BACKGROUND


Intermittent theta-burst stimulation (iTBS), a novel repetitive transcranial magnetic stimulation (rTMS) technique, appears to have antidepressant effects when applied over left dorsolateral prefrontal cortex (DLPFC). However, its underlying neurobiological mechanisms are unclear. Proton magnetic resonance spectroscopy ( 1 H-MRS) provides in vivo measurements of cerebral metabolites altered in major depressive disorder (MDD) like N-acetyl-aspartate (NAA) and choline-containing compounds (Cho). We used MRS to analyse effects of iTBS on the associations between the shifts in the NAA and Cho levels during therapy and MDD improvement.
METHODS


In-patients with unipolar MDD (N = 57), in addition to treatment as usual, were randomized to receive 20 iTBS or sham stimulations applied over left DLPFC over four weeks. Single-voxel  1 H-MRS of the anterior cingulate cortex (ACC) was performed at baseline and follow-up. Increments of concentrations, as well as MDD improvement, were defined as endpoints. We tested a moderated mediation model of effects using the PROCESS macro (an observed variable ordinary least squares and logistic regression path analysis modeling tool) for SPSS.
RESULTS


Improvement of depressive symptoms was significantly associated with decrease of Cho/NAA ratio, mediated by NAA. iTBS had a significant moderating effect enhancing the relationship between NAA change and depression improvement.
CONCLUSIONS


Our findings suggest a potential neurochemical pathway and mechanisms of antidepressant action of iTBS, which may moderate the improvement of metabolic markers of neuronal viability. iTBS might increase neuroplasticity, thus facilitating normalization of neuronal circuit function.",2020,Single-voxel  1 H-MRS of the anterior cingulate cortex (ACC) was performed at baseline and follow-up.,[],"['Intermittent theta-burst stimulation (iTBS', '20 iTBS or sham stimulations applied over left DLPFC', 'repetitive transcranial magnetic stimulation (rTMS) technique', 'Proton magnetic resonance spectroscopy ( 1 H-MRS']","['Cho/NAA ratio', 'NAA change and depression improvement', 'depressive symptoms', 'unipolar depression']",[],"[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]",,0.0453926,Single-voxel  1 H-MRS of the anterior cingulate cortex (ACC) was performed at baseline and follow-up.,"[{'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Zavorotnyy', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Department of Psychiatry and Psychotherapy, Psychiatric Services Aargau, Academic Hospital of the University of Zurich, Brugg, Switzerland; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany. Electronic address: maxim.zavorotnyy@staff.uni-marburg.de.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Zöllner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Health Protection Authority, Frankfurt, Main, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Rekate', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Dietsche', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Bopp', 'Affiliation': 'Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany; Department of Neurosurgery, University of Marburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Sommer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Meller', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Krug', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Nenadić', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}]",Brain stimulation,['10.1016/j.brs.2020.03.015']
134,32380449,Effects of high-frequency repetitive transcranial magnetic stimulation over the contralesional motor cortex on motor recovery in severe hemiplegic stroke: A randomized clinical trial.,"BACKGROUND


The contralesional hemisphere compensation may play a critical role in the recovery of stroke when there is extensive damage to one hemisphere. There is little research on the treatment of hemiplegia by high-frequency repetitive transcranial magnetic stimulation (rTMS) delivered to the contralesional cortex.
OBJECTIVE


We conducted a 2-week randomized, sham-controlled, single-blind trial to determine whether high-frequency rTMS (HF-rTMS) over the contralesional motor cortex can improve motor function in severe stroke patients.
METHODS


Forty-five patients with ischemic or hemorrhagic stroke in the middle cerebral artery territory were randomly assigned to treatment with 10 Hz rTMS (HF group), 1 Hz rTMS (LF group) or sham rTMS (sham group) applied over the contralesional motor cortex (M1) before physiotherapy daily for two weeks. The primary outcome was the change in the Fugl-Meyer Motor Assessment (FMA) Scale score from baseline to 2 weeks. The secondary endpoints included root mean square of surface electromyography (RMS-SEMG), Barthel Index (BI), and contralesional hemisphere cortical excitability.
RESULTS


The HF group showed a more significant improvement in FMA score (p < 0.05), BI (p < 0.005), contralesional hemisphere cortical excitability and conductivity (p < 0.05), and RMS-SEMG of the key muscles (p < 0.05) compared with the LF group and sham group. There were no significant differences between the LF group and sham group. There was a positive correlation between cortical conductivity of the uninjured hemisphere and recovery of motor impairment (p = 0.039).
CONCLUSIONS


HF-rTMS over the contralesional cortex was superior to low-frequency rTMS and sham stimulation in promoting motor recovery in patients with severe hemiplegic stroke by acting on contralesional cortex plasticity.
TRIAL REGISTRATION


Clinical trial registered with the Chinese Clinical Trial Registry at http://www.chictr.org.cn/showproj.aspx?proj=23264 (ChiCTR-IPR-17013580).",2020,"The HF group showed a more significant improvement in FMA score (p < 0.05), BI (p < 0.005), contralesional hemisphere cortical excitability and conductivity (p < 0.05), and RMS-SEMG of the key muscles (p < 0.05) compared with the LF group and sham group.","['severe hemiplegic stroke', 'Forty-five patients with ischemic or hemorrhagic stroke in the middle cerebral artery territory', 'patients with severe hemiplegic stroke', 'severe stroke patients']","['high-frequency repetitive transcranial magnetic stimulation', 'HF-rTMS', 'high-frequency rTMS (HF-rTMS', 'repetitive transcranial magnetic stimulation (rTMS', '10\xa0Hz rTMS (HF group), 1\xa0Hz rTMS (LF group) or sham rTMS (sham group) applied over the contralesional motor cortex (M1) before physiotherapy daily for two weeks']","['FMA score', 'root mean square of surface electromyography (RMS-SEMG), Barthel Index (BI), and contralesional hemisphere cortical excitability', 'change in the Fugl-Meyer Motor Assessment (FMA) Scale score', 'cortical conductivity of the uninjured hemisphere and recovery of motor impairment', 'contralesional hemisphere cortical excitability and conductivity', 'RMS-SEMG of the key muscles']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}]","[{'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0013777', 'cui_str': 'Electrical Conductivity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",45.0,0.537609,"The HF group showed a more significant improvement in FMA score (p < 0.05), BI (p < 0.005), contralesional hemisphere cortical excitability and conductivity (p < 0.05), and RMS-SEMG of the key muscles (p < 0.05) compared with the LF group and sham group.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Ying-Yu', 'Initials': 'YY', 'LastName': 'Zhao', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Hai', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yue-Wen', 'Initials': 'YW', 'LastName': 'Ma', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China. Electronic address: mayw@cmu1h.com.'}]",Brain stimulation,['10.1016/j.brs.2020.03.020']
135,32384426,A phase I/IIa double blind single institute trial of low dose sirolimus for Pendred syndrome/DFNB4.,"INTRODUCTION


Pendred syndrome (PDS)/DFNB 4 is a disorder with fluctuating and progressive hearing loss, vertigo, and thyroid goiter. We identified pathophysiology of a neurodegenerative disorder in PDS patient derived cochlear cells that were induced via induced pluripotent stem cells and found sirolimus, an mTOR inhibitor, as an inhibitor of cell death with the minimum effective concentration less than 1/10 of the approved dose for other diseases. Given that there is no rational standard therapy for PDS, we planned a study to examine effects of low dose oral administration of sirolimus for the fluctuating and progressive hearing loss, and the balance disorder of PDS by daily monitor of their audio-vestibular symptoms.
METHODS AND ANALYSIS


This is a phase I/IIa double blind parallel-group single institute trial in patient with PDS/DFNB4. Sixteen of outpatients with fluctuating hearing diagnosed as PDS in SLC26A4 genetic testing aged in between 7 and 50 years old at the time of consent are given either placebo or sirolimus tablet (NPC-12T). In NPC-12T placebo arm, placebo will be given for 36 weeks; in active substance arm, placebo will be given for 12 weeks and the NPC-12T for 24 weeks. Primary endpoints are safety and tolerability. The number of occurrences and types of adverse events and of side effects will be sorted by clinical symptoms and by abnormal change of clinical test results. A 2-sided 95% confidence interval of the incidence rate by respective dosing arms will be calculated using the Clopper-Pearson method. Clinical effects on audio-vestibular tests performed daily and precise physiological test at each visit will also be examined as secondary and expiratory endpoints.
TRIAL REGISTRATION NUMBER


JMA-IIA00361; Pre-results.",2020,The number of occurrences and types of adverse events and of side effects will be sorted by clinical symptoms and by abnormal change of clinical test results.,"['patient with PDS/DFNB4', 'Sixteen of outpatients with fluctuating hearing diagnosed as PDS in SLC26A4 genetic testing aged in between 7 and 50 years old at the time of consent are given either', 'Pendred syndrome/DFNB4']","['placebo or sirolimus tablet (NPC-12T', 'placebo', 'NPC-12T placebo', 'sirolimus']","['number of occurrences and types of adverse events', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C3538946', 'cui_str': 'Dilated Vestibular Aqueduct'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0231241', 'cui_str': 'Fluctuating'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0028587', 'cui_str': 'Nuclear Pore'}]","[{'cui': 'C0449789', 'cui_str': 'Number of occurrences'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.43163,The number of occurrences and types of adverse events and of side effects will be sorted by clinical symptoms and by abnormal change of clinical test results.,"[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Fujioka', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Akiyama', 'Affiliation': 'Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Hosoya', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Kikuchi', 'Affiliation': 'Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Fujiki', 'Affiliation': 'Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Yoshihama', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ozawa', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Tsukada', 'Affiliation': 'Department of Otorhinolaryngology, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Shin-Ya', 'Initials': 'SY', 'LastName': 'Nishio', 'Affiliation': 'Department of Otorhinolaryngology, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Usami', 'Affiliation': 'Department of Otorhinolaryngology, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Matsunaga', 'Affiliation': 'Department of Otolaryngology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Tomonobu', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Pediatrics, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}]",Medicine,['10.1097/MD.0000000000019763']
136,32384434,In vivo investigation on bio-markers of perimenopausal panic disorder and catgut embedding acupoints mechanism.,"BACKGROUND


Panic disorder (PD), defined by repeated and unexpected panic attacks, severely affects patients' living quality and social function. Perimenopausal women are high-risk group of PD and suffer greatly from it. Modern medicine therapies for this disorder have many side reactions and poor effects, so nonpharmacological modality is an urgent need. Although acupoint catgut embedding is widely used in clinical practice, there is no persuasive evidence of its effect for perimenopausal PD. The aim of this study is to investigate the effectiveness and safety of acupoint catgut embedding for perimenopausal PD and to elucidate the correlations among brain neural activation, bio-markers (amino acids) and clinical outcomes with radiographic evidence, thus to explore its neural mechanism.
METHODS


The parallel designed, exploratory randomized controlled trial will include 70 outpatients with perimenopausal PD recruited from two hospitals of Chinese Medicine. These subjects will be randomly allocated to an intervention group (Group Embedding) and a control group (Group Medication) in a 1:1 ratio. The subjects in the intervention group will receive acupoint catgut embedding treatment two weeks a time in the following predefined acupuncture points: Shenshu (BL23), Sanyinjiao (SP6), Guanyuan (RN4), Ganshu (BL18), Zusanli (ST36) and Pishu (BL20). The included women of the control group will take 0.4 mg Alprazolam tablet orally, 1 tablet a time, 3 times a day. There is a study period of 3 months and a follow-up period of 1 month for each group. The primary outcomes will be the following therapeutic indexes: the frequency of panic attack, Panic Disorder Severity Score (PDSS), and Panic-associated Symptoms Score (PASS) during the observation period and follow-up period. The changes in Hamilton Anxiety Scale (HAMA) Score and Symptom Checklist 90 (SCL-90) Score will also be compared between these two groups. Additionally, functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy (1H-MRS) scans will be done before and after the observation period to show cranial neuroimaging changes.
DISCUSSION


We present a study design and rationale to explore the effectiveness and neural mechanism of acupoint catgut embedding for perimenopausal PD. There are still several factors restrict our research such as no unified standard of diagnostic criteria and curative effect evaluation.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR-INR-16009724, registered in November 2016.",2020,The changes in Hamilton Anxiety Scale (HAMA) Score and Symptom Checklist 90 (SCL-90) Score will also be compared between these two groups.,"['70 outpatients with perimenopausal PD recruited from two hospitals of Chinese Medicine', 'perimenopausal PD', 'Perimenopausal women']","['Alprazolam', 'acupoint catgut embedding treatment two weeks a time in the following predefined acupuncture points: Shenshu (BL23), Sanyinjiao (SP6), Guanyuan (RN4), Ganshu (BL18), Zusanli (ST36) and Pishu (BL20', 'control group (Group Medication', 'functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy (1H-MRS) scans', 'acupoint catgut embedding']","['frequency of panic attack, Panic Disorder Severity Score (PDSS), and Panic-associated Symptoms Score (PASS', 'Hamilton Anxiety Scale (HAMA) Score and Symptom Checklist 90 (SCL-90) Score']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0007420', 'cui_str': 'Catgut'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0450614', 'cui_str': 'BL20'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0086769', 'cui_str': 'Panic attack'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}]",70.0,0.0811251,The changes in Hamilton Anxiety Scale (HAMA) Score and Symptom Checklist 90 (SCL-90) Score will also be compared between these two groups.,"[{'ForeName': 'Guizhen', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""The Bao'an District TCM Hospital, The Affiliated Hospital of Guangzhou University of Chinese Medicine, Shenzhen.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xiaokang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Junquan', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yunxiang', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}]",Medicine,['10.1097/MD.0000000000019909']
137,32384437,Extracorporeal shock wave therapy versus corticosteroid injection for chronic plantar fasciitis: A protocol of randomized controlled trial.,"BACKGROUND


The outcomes of corticosteroid injection (CSI) and extracorporeal shock wave therapy (ESWT) as primary treatment of plantar fasciitis have been debated. This study was conducted to compare and evaluate the therapeutic effects of ultrasound-guided CSI versus medium frequency ESWT in the treatment of plantar fasciitis among Chinese population.
METHODS


This study was a single-center, randomized, and double-blinded trial. The study protocol was approved by local ethics committee board and subsequently registered in Research Registry. Eighty patients with unilateral plantar fasciitis were randomized to receive either ESWT (3 times once per week) (n = 40) or CSI treatment (a single 1-mL dose of betamethasone sodium plus 0.5 mL of prilocaine under ultrasound guidance by injection into the plantar fascia) (n = 40). The primary outcome measures were visual analog scale and Foot Function Index scores. Secondary outcome measures included the heel tenderness index score and plantar fascia thickness as obtained by ultrasound examination. All of the assessments were performed at baseline and 1, 3, and 6 months after treatment.
RESULTS


This is a randomized controlled trial evaluating the efficacy of CSI versus ESWT in the treatment of plantar fasciitis. This study has limited inclusion and exclusion criteria and a well-controlled intervention.
CONCLUSIONS


The results of this trial will provide more evidence on which method can better treat plantar fasciitis.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5428).",2020,Eighty patients with unilateral plantar fasciitis were randomized to receive either ESWT (3 times once per week) (n = 40) or CSI treatment (a single 1-mL dose of betamethasone sodium plus 0.5 mL of prilocaine under ultrasound guidance by injection into the plantar fascia) (n = 40).,"['chronic plantar fasciitis', 'plantar fasciitis among Chinese population', 'plantar fasciitis', 'Eighty patients with unilateral plantar fasciitis']","['corticosteroid injection (CSI) and extracorporeal shock wave therapy (ESWT', 'ultrasound-guided CSI versus medium frequency ESWT', 'betamethasone sodium plus 0.5\u200amL of prilocaine', 'Extracorporeal shock wave therapy versus corticosteroid injection', 'CSI treatment', 'ESWT', 'CSI versus ESWT']","['visual analog scale and Foot Function Index scores', 'heel tenderness index score and plantar fascia thickness as obtained by ultrasound examination']","[{'cui': 'C1136148', 'cui_str': 'Fasciitis, Plantar, Chronic'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}]",80.0,0.206775,Eighty patients with unilateral plantar fasciitis were randomized to receive either ESWT (3 times once per week) (n = 40) or CSI treatment (a single 1-mL dose of betamethasone sodium plus 0.5 mL of prilocaine under ultrasound guidance by injection into the plantar fascia) (n = 40).,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Traumatic Orthopedics, Weifang People's Hospital, Weifang, Shandong, 261041.""}, {'ForeName': 'Wen Ming', 'Initials': 'WM', 'LastName': 'Luo', 'Affiliation': ""Department of Traumatic Orthopedics, Weifang People's Hospital, Weifang, Shandong, 261041.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, Weifang Maternal and Child health Hospital, Weifang, Shandong, 261000, China.'}]",Medicine,['10.1097/MD.0000000000019920']
138,32391667,[A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19].,"OBJECTIVE


To evaluate the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of patients with moderate coronavirus disease 2019 (COVID-19).
METHODS


We prospectively enrolled 30 treatment-naïve patients with confirmed COVID-19 after informed consent at Shanghai Public Health Clinical Center. The patients were randomized 1：1 to HCQ group and the control group. Patients in HCQ group were given HCQ 400 mg per day for 5 days plus conventional treatments, while those in the control group were given conventional treatment only. The primary endpoint was negative conversion rate of SARS-CoV-2 nucleic acid in respiratory pharyngeal swab on days 7 after randomization. This study has been approved by the Ethics Committee of Shanghai Public Health Clinical Center and registered online (NCT04261517).
RESULTS


One patient in HCQ group developed to severe during the treatment. On day 7, nucleic acid of throat swabs was negative in 13 (86.7%) cases in the HCQ group and 14 (93.3%) cases in the control group ( P >0.05). The median duration from hospitalization to virus nucleic acid negative conservation was 4 (1,9) days in HCQ group, which is comparable to that in the control group [2 (1,4) days, Z=1.27,  P >0.05]. The median time for body temperature normalization in HCQ group was 1 (0,2) day after hospitalization, which was also comparable to that in the control group [1 (0,3) day]. Radiological progression was shown on CT images in 5 cases (33.3%) of the HCQ group and 7 cases (46.7%) of the control group, and all patients showed improvement in follow-up examinations. Four cases (26.7%) of the HCQ group and 3 cases (20%) of the control group had transient diarrhea and abnormal liver function ( P >0.05).
CONCLUSIONS


The prognosis of COVID-19 moderate patients is good. Larger sample size study are needed to investigate the effects of HCQ in the treatment of COVID-19. Subsequent research should determine better endpoint and fully consider the feasibility of experiments such as sample size.",2020,"On day 7, nucleic acid of throat swabs was negative in 13 (86.7%) cases in the HCQ group and 14 (93.3%) cases in the control group ( P >0.05).","['patients with moderate COVID-19', 'patients with moderate coronavirus disease 2019 (COVID-19', 'enrolled 30 treatment-naïve patients with confirmed COVID-19 after informed consent at Shanghai Public Health Clinical Center']","['HCQ', 'hydroxychloroquine (HCQ', 'hydroxychloroquine']","['Radiological progression', 'transient diarrhea and abnormal liver function', 'efficacy and safety', 'median duration from hospitalization to virus nucleic acid negative conservation', 'negative conversion rate of SARS-CoV-2 nucleic acid', 'median time for body temperature normalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",30.0,0.0309209,"On day 7, nucleic acid of throat swabs was negative in 13 (86.7%) cases in the HCQ group and 14 (93.3%) cases in the control group ( P >0.05).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Danping', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Qingnian', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Yinzhong', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}]",Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences,[]
139,32391695,Ultrafast Excitation Transfer in Cy5 DNA Photonic Wires Displays Dye Conjugation and Excitation Energy Dependency.,"DNA scaffolds enable base-pair-specific positioning of fluorescent molecules, allowing for nanometer-scale precision in controlling multidye interactions. Expanding on this concept, DNA-based molecular photonic wires (MPWs) allow for light harvesting and directional propagation of photonic energy on the nanometer scale. The most common MPW examples exploit Förster resonance energy transfer (FRET), and FRET between the same dye species (HomoFRET) was recently shown to increase the distance and efficiency at which MPWs can function. Although increased proximity between adjacent fluorophores can be used to increase the energy transfer efficiency, FRET assumptions break down as the distance between the dye molecules becomes comparable to their size (∼2 nm). Here we compare dye conjugation with single versus dimer Cy5 dye repeats as HomoFRET MPW components on a double-crossover DNA scaffold. At room temperature (RT) under low-light conditions, end-labeled uncoupled dye molecules provide optimal transfer, while the Cy5 dimers show ultrafast (<100 ps) nonradiative decay that severely limits their functionality. Of particular interest is the observation that through increased excitation fluence as well as cryogenic temperatures, the dimeric MPW shows suppression of the ultrafast decay, demonstrating fluorescence lifetimes similar to the single Cy5 MPWs. This work points to the complex dynamic capabilities of dye-based nanophotonic networks, where dye positioning and interactions can become critical, and could be used to extend the lengths and complexities of such dye-DNA devices, enabling multiparameter nanophotonic circuitry.",2020,"DNA scaffolds enable base-pair-specific positioning of fluorescent molecules, allowing for nanometer-scale precision in controlling multidye interactions.",[],[],['excitation fluence'],[],[],[],,0.0251721,"DNA scaffolds enable base-pair-specific positioning of fluorescent molecules, allowing for nanometer-scale precision in controlling multidye interactions.","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Mazuski', 'Affiliation': 'Department of Chemistry, Institute for Biophysical Dynamics, and James Franck Institute, University of Chicago, Chicago, Illinois 60637, United States.'}, {'ForeName': 'Sebastián A', 'Initials': 'SA', 'LastName': 'Díaz', 'Affiliation': 'Center for Bio/Molecular Science and Engineering, Code 6900, U.S. Naval Research Laboratory, Washington, D.C. 20375, United States.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Wood', 'Affiliation': 'Department of Chemistry, Institute for Biophysical Dynamics, and James Franck Institute, University of Chicago, Chicago, Illinois 60637, United States.'}, {'ForeName': 'Lawson T', 'Initials': 'LT', 'LastName': 'Lloyd', 'Affiliation': 'Department of Chemistry, Institute for Biophysical Dynamics, and James Franck Institute, University of Chicago, Chicago, Illinois 60637, United States.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Klein', 'Affiliation': 'Center for Bio/Molecular Science and Engineering, Code 6900, U.S. Naval Research Laboratory, Washington, D.C. 20375, United States.'}, {'ForeName': 'Divita', 'Initials': 'D', 'LastName': 'Mathur', 'Affiliation': 'Center for Bio/Molecular Science and Engineering, Code 6900, U.S. Naval Research Laboratory, Washington, D.C. 20375, United States.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Melinger', 'Affiliation': 'Electronic Science and Technology Division, Code 6800, U.S. Naval Research Laboratory, Washington, D.C. 20375, United States.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Engel', 'Affiliation': 'Department of Chemistry, Institute for Biophysical Dynamics, and James Franck Institute, University of Chicago, Chicago, Illinois 60637, United States.'}, {'ForeName': 'Igor L', 'Initials': 'IL', 'LastName': 'Medintz', 'Affiliation': 'Center for Bio/Molecular Science and Engineering, Code 6900, U.S. Naval Research Laboratory, Washington, D.C. 20375, United States.'}]",The journal of physical chemistry letters,['10.1021/acs.jpclett.0c01020']
140,32387214,"Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis-an open labelled, randomized controlled trial.","AIMS & OBJECTIVES


The hand-sewn method of bowel anastomosis is the most common because of its affordability, familiarity and easy availability of materials. It can be done in single or double layers, with different surgeons preferring one technique over the other. Double layer intestinal anastomosis (DLIA) is time-consuming, challenging to perform, and carries possibly a higher risk of devascularisation, infection, and necrosis. Studies conducted so far do not show a significant difference between the two, but have concluded that more studies are required to determine this definitively. This study attempted to see whether the single layer intestinal anastomosis (SLIA) is non-inferior to DLIA in terms of incidence of anastomotic leak. It also compared mortality, morbidity, and length of hospitalization (LOH) between the two groups.
MATERIALS AND METHODS


This was a parallel arm, open labelled, non-inferiority randomized controlled trial conducted in the department of surgery in a tertiary care centre between October 2016 and March 2018. Patients who fulfilled the inclusion criteria were randomly allotted to two groups: Patients undergoing SLIA and patients undergoing DLIA. After the procedure, all patients were assessed for anastomotic leak, morbidity, mortality and LOH in the postoperative period. A 3-month follow-up period was observed for complications.
RESULTS


A total of 106 patients were randomised, 52 in SLIA and 54 in DLIA. Baseline demographic and clinicopathological characteristics between the two groups were comparable. The most common indication for intestinal anastomosis was ostomy closure in both groups. There was no significant difference between the two groups in terms of anastomotic leak, other complications, mortality and LOH.
CONCLUSION


SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalization, and can be considered as a safe and feasible alternative, in elective and emergency settings.",2020,"SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalisation, and can be considered as a safe and feasible alternative, in elective and emergency settings.","['Patients who fulfilled the inclusion criteria', 'department of surgery in a tertiary care centre between October 2016 and March 2018', '106 patients were randomised, 52 in SLIA and 54 in DLIA']","['single layered intestinal anastomosis', 'single layer intestinal anastomosis (SLIA', 'Double layer intestinal anastomosis (DLIA', 'SLIA and patients undergoing DLIA']","['anastomotic leak, other complications, mortality and LOH.\nCONCLUSION', 'mortality, morbidity, and length of hospitalisation (LOH', 'Baseline demographic and clinicopathological characteristics', 'anastomotic leak, morbidity, mortality, and the length of hospitalisation', 'anastomotic leak, morbidity, mortality and LOH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",106.0,0.173847,"SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalisation, and can be considered as a safe and feasible alternative, in elective and emergency settings.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aniruthan', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Amuda Ravichandar', 'Initials': 'AR', 'LastName': 'Pranavi', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Gubbi Shamanna', 'Initials': 'GS', 'LastName': 'Sreenath', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kate', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: dr.sreenathgs@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.04.066']
141,32387690,Vein conduits used to enhance arterial microsurgical end-to-end suture repair: A randomized comparative study.,"Wrapping microsurgical sutures with a vein conduit is a well-described procedure for microsurgical nerve repair. While this has rarely been described in the context of vascular repair, this technique could increase the permeability of the sutured vessels. As part of a University Diploma in Microsurgery, 9 junior surgeons performed a comparative study of 18 microsurgical repairs on rats with and without vein sleeve. The vessels used were an external jugular vein sleeve on the end-to-end anastomosis of the common carotid artery and comparing it to this same anastomosis without a sleeve. The data analyzed were rat weight, suture time with carotid clamping time, number of stitches used, complications as well as vascular leakage and permeability of the repair at 0 and 5minutes evaluated with a patency test. The average rat body weight was 255g. Mean suture time was 52minutes in group A (sleeved repairs) and 41minutes in group B (standard repairs). The number of stitches placed was 5.1 points on average in group A and 5.6 points in group B. The time to perform the repair and the number of stitches was not statistically different between groups. The patency test was positive in 100% of cases in group A and in 78% of cases in group B. There was a significant difference between the permeability rate of the repairs, with better results in group A (p=0.03). There were two anastomotic leaks after declamping in the sleeve group and five in the standard suture group, thus 2.5 times more leaks in the group without a sleeve (p<0.01). The addition of a vein sleeve around an end-to-end arterial suture repair seems to improve its permeability and therefore its reliability.",2020,"There were two anastomotic leaks after declamping in the sleeve group and five in the standard suture group, thus 2.5 times more leaks in the group without a sleeve (p<0.01).",[],"['18 microsurgical repairs on rats with and without vein sleeve', 'Vein conduits used to enhance arterial microsurgical end-to-end suture repair', 'external jugular vein sleeve', 'Wrapping microsurgical sutures with a vein conduit']","['average rat body weight', 'rat weight, suture time with carotid clamping time, number of stitches used, complications as well as vascular leakage and permeability of the repair at 0 and 5 minutes evaluated with a patency test', 'permeability rate', 'number of stitches placed', 'patency test', 'time to perform the repair and the number of stitches', 'Mean suture time', 'anastomotic leaks']",[],"[{'cui': 'C0567345', 'cui_str': 'Microsurgical repair'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0441247', 'cui_str': 'Conduit'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0226543', 'cui_str': 'Structure of external jugular vein'}]","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}]",,0.0395513,"There were two anastomotic leaks after declamping in the sleeve group and five in the standard suture group, thus 2.5 times more leaks in the group without a sleeve (p<0.01).","[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Lancien', 'Affiliation': 'Department of Plastic, Reconstructive Surgery, Burns Centre, University Hospital Nantes, 1, place Alexis-Ricordeau, 44000 Nantes, France. Electronic address: ulancien@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Delaveau', 'Affiliation': 'Department of Orthopedic and Traumatology surgery, University Hospital Poitiers, 2, rue de la Milétrie, 86021 Poitiers, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pouedras', 'Affiliation': 'Department of Orthopedic and Traumatology surgery, University Hospital Nantes, 1, place Alexis-Ricordeau, 44000 Nantes, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fortier', 'Affiliation': 'Department of Urology, University Hospital Angers, 4, rue Larrey, 49100 Angers, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bin', 'Affiliation': 'Department of Orthopedic pediatric surgery, Angers University Hospital, 4, rue Larrey, 49100 Angers, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ghersallah', 'Affiliation': 'Department of Stomatology and Maxillofacial Surgery, Hospital of Le Mans, 194, avenue Rubillard, 72037 Le Mans, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jeudy', 'Affiliation': 'Centre de la Main\xa0-\xa0Angers assistance-main, 47, rue de la Foucaudière, 49000 Trélazé, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Saint-Cast', 'Affiliation': 'Centre de la Main\xa0-\xa0Angers assistance-main, 47, rue de la Foucaudière, 49000 Trélazé, France.'}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Fournier', 'Affiliation': 'Department of Neurosurgery, Laboratory of Anatomy, rue Haute de Reculée, 49000 Angers, France.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2020.04.009']
142,32369436,Total versus partial knee replacement in patients with medial compartment knee osteoarthritis: the TOPKAT RCT.,"BACKGROUND


Late-stage medial compartment knee osteoarthritis can be treated using total knee replacement or partial (unicompartmental) knee replacement. There is high variation in treatment choice and insufficient evidence to guide selection.
OBJECTIVE


To assess the clinical effectiveness and cost-effectiveness of partial knee replacement compared with total knee replacement in patients with medial compartment knee osteoarthritis. The findings are intended to guide surgical decision-making for patients, surgeons and health-care providers.
DESIGN


This was a randomised, multicentre, pragmatic comparative effectiveness trial that included an expertise component. The target sample size was 500 patients. A web-based randomisation system was used to allocate treatments.
SETTING


Twenty-seven NHS hospitals (68 surgeons).
PARTICIPANTS


Patients with medial compartment knee osteoarthritis.
INTERVENTIONS


The trial compared the overall management strategy of partial knee replacement treatment with total knee replacement treatment. No specified brand or subtype of implant was investigated.
MAIN OUTCOME MEASURES


The Oxford Knee Score at 5 years was the primary end point. Secondary outcomes included activity scores, global health measures, transition items, patient satisfaction (Lund Score) and complications (including reoperation, revision and composite 'failure' - defined by minimal Oxford Knee Score improvement and/or reoperation). Cost-effectiveness was also assessed.
RESULTS


A total of 528 patients were randomised (partial knee replacement,  n  = 264; total knee replacement,  n  = 264). The follow-up primary outcome response rate at 5 years was 88% and both operations had good outcomes. There was no significant difference between groups in mean Oxford Knee Score at 5 years (difference 1.04, 95% confidence interval -0.42 to 2.50). An area under the curve analysis of the Oxford Knee Score at 5 years showed benefit in favour of partial knee replacement over total knee replacement, but the difference was within the minimal clinically important difference [mean 36.6 (standard deviation 8.3) ( n  = 233), mean 35.1 (standard deviation 9.1) ( n  = 231), respectively]. Secondary outcome measures showed consistent patterns of benefit in the direction of partial knee replacement compared with total knee replacement although most differences were small and non-significant. Patient-reported improvement (transition) and reflection (would you have the operation again?) showed statistically significant superiority for partial knee replacement only, but both of these variables could be influenced by the lack of blinding. The frequency of reoperation (including revision) by treatment received was similar for both groups: 22 out of 245 for partial knee replacement and 28 out of 269 for total knee replacement patients. Revision rates at 5 years were 10 out of 245 for partial knee replacement and 8 out of 269 for total knee replacement. There were 28 'failures' of partial knee replacement and 38 'failures' of total knee replacement (as defined by composite outcome). Beyond 1 year, partial knee replacement was cost-effective compared with total knee replacement, being associated with greater health benefits (measured using quality-adjusted life-years) and lower health-care costs, reflecting lower costs of the index surgery and subsequent health-care use.
LIMITATIONS


It was not possible to blind patients in this study and there was some non-compliance with the allocated treatment interventions. Surgeons providing partial knee replacement were relatively experienced with the procedure.
CONCLUSIONS


Both total knee replacement and partial knee replacement are effective, offer similar clinical outcomes and have similar reoperation and complication rates. Some patient-reported measures of treatment approval were significantly higher for partial knee replacement than for total knee replacement. Partial knee replacement was more cost-effective (more effective and cost saving) than total knee replacement at 5 years.
FUTURE WORK


Further (10-year) follow-up is in progress to assess the longer-term stability of these findings.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN03013488 and ClinicalTrials.gov NCT01352247.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 20. See the NIHR Journals Library website for further project information.",2020,"Both total knee replacement and partial knee replacement are effective, offer similar clinical outcomes and have similar reoperation and complication rates.","['Patients with medial compartment knee osteoarthritis', '528 patients were randomised (partial knee replacement,  n \u2009=\u2009264; total knee replacement,  n \u2009=\u2009264', 'Twenty-seven NHS hospitals (68 surgeons', 'patients with medial compartment knee osteoarthritis']","['partial knee replacement treatment with total knee replacement treatment', 'total knee replacement or partial (unicompartmental) knee replacement', 'partial knee replacement', 'total knee replacement', 'Partial knee replacement']","['Cost-effectiveness', 'health benefits', ""activity scores, global health measures, transition items, patient satisfaction (Lund Score) and complications (including reoperation, revision and composite 'failure' - defined by minimal Oxford Knee Score improvement and/or reoperation"", 'clinical effectiveness and cost-effectiveness', 'frequency of reoperation (including revision', 'mean Oxford Knee Score', 'Revision rates', 'health-care costs, reflecting lower costs of the index surgery and subsequent health-care use', 'cost-effective (more effective and cost saving', 'patterns of benefit in the direction of partial knee replacement compared with total knee replacement', 'response rate', ""failures' of partial knee replacement and 38 'failures' of total knee replacement""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0447798', 'cui_str': 'Compartment of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",528.0,0.0963477,"Both total knee replacement and partial knee replacement are effective, offer similar clinical outcomes and have similar reoperation and complication rates.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Loretta J', 'Initials': 'LJ', 'LastName': 'Davies', 'Affiliation': 'Nuffield Department of Orthopaedics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Cook', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Price', 'Affiliation': 'Nuffield Department of Orthopaedics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Seamus', 'Initials': 'S', 'LastName': 'Kent', 'Affiliation': 'Department of Public Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Carr', 'Affiliation': 'Nuffield Department of Orthopaedics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Department of Public Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': 'Department of Public Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Public Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Arden', 'Affiliation': 'Nuffield Department of Orthopaedics, University of Oxford, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Murray', 'Affiliation': 'Nuffield Department of Orthopaedics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marion K', 'Initials': 'MK', 'LastName': 'Campbell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24200']
143,32370588,Comprehensive Management With the ABC (Atrial Fibrillation Better Care) Pathway in Clinically Complex Patients With Atrial Fibrillation: A Post Hoc Ancillary Analysis From the AFFIRM Trial.,"Background For patients with atrial fibrillation, a comprehensive care approach based on the Atrial fibrillation Better Care (ABC) pathway can reduce the occurrence of adverse outcomes. The aim of this paper was to investigate if an approach based on the ABC pathway is associated with a reduced risk of adverse events in ""clinically complex"" atrial fibrillation patients, including those with multiple comorbidities, polypharmacy, and prior hospitalizations. Methods and Results We performed a post hoc analysis of the AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management) trial. The principal outcome was the composite of all-cause hospitalization and all-cause death. An integrated care approach (ABC group) was used in 3.8% of the multimorbidity group, 4.0% of the polypharmacy group, and 4.8%, of the hospitalized groups. In all ""clinically complex"" groups, the cumulative risk of the composite outcome was significantly lower in patients managed consistent with the ABC pathway versus non-ABC pathway-adherent (all  P <0.05). Cox regression analysis showed a reduction of composite outcomes in ABC pathway-adherent versus non-ABC pathway-adherent for multimorbidity (hazard ratio [HR], 0.61, 95% CI, 0.44-0.85), polypharmacy (HR, 0.68, 95% CI, 0.47-1.00), and hospitalization (HR, 0.59, 95% CI, 0.42-0.85) groups. Secondary analyses showed that the higher number of ABC criteria fulfilled the larger associated reduction in relative risk, even for secondary outcomes considered. Conclusions Use of an ABC consistent pathway is associated with fewer major adverse events in patients with atrial fibrillation who have multiple comorbidities, use of polypharmacy, and prior hospitalization.",2020,"Cox regression analysis showed a reduction of composite outcomes in ABC pathway-adherent versus non-ABC pathway-adherent for multimorbidity (hazard ratio [HR], 0.61, 95% CI, 0.44-0.85), polypharmacy (HR, 0.68, 95% CI, 0.47-1.00), and hospitalization (HR, 0.59, 95% CI, 0.42-0.85) groups.","['Atrial Fibrillation Better Care', 'patients with atrial fibrillation who have multiple comorbidities, use of polypharmacy, and prior hospitalization', 'patients with atrial fibrillation', 'Clinically Complex Patients With Atrial Fibrillation', 'clinically complex"" atrial fibrillation patients']",['ABC'],"['cumulative risk of the composite outcome', 'composite of all-cause hospitalization and all-cause death']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0434019,"Cox regression analysis showed a reduction of composite outcomes in ABC pathway-adherent versus non-ABC pathway-adherent for multimorbidity (hazard ratio [HR], 0.61, 95% CI, 0.44-0.85), polypharmacy (HR, 0.68, 95% CI, 0.47-1.00), and hospitalization (HR, 0.59, 95% CI, 0.42-0.85) groups.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Proietti', 'Affiliation': 'Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart & Chest Hospital Liverpool United Kingdom.'}, {'ForeName': 'Giulio Francesco', 'Initials': 'GF', 'LastName': 'Romiti', 'Affiliation': 'Department of Internal Medicine and Medical Specialties Sapienza-University of Rome Italy.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Olshansky', 'Affiliation': 'Division of Cardiovascular Medicine University of Iowa Hospitals and Clinics Iowa City IA.'}, {'ForeName': 'Deirdre A', 'Initials': 'DA', 'LastName': 'Lane', 'Affiliation': 'Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart & Chest Hospital Liverpool United Kingdom.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart & Chest Hospital Liverpool United Kingdom.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014932']
144,32370637,Angiotensin II type 1 receptor blockers favorably affect renal angiotensin II and MAS receptor expression in patients with diabetic nephropathy.,"INTRODUCTION


The aims of this study were to assess the renal expression of angiotensin II type 1 receptor (AT1R), angiotensin II type 2 receptor (AT2R), and MAS receptor in human type 2 diabetic nephropathy (DN).
MATERIALS AND METHODS


In total, 115 patients diagnosed with DN by renal biopsy were enrolled in this study. The protein expression levels of the AT1R, AT2R, and MAS receptors were assessed by immunohistochemistry.
RESULTS


The protein expression levels of AT1R, AT2R, and MAS receptor in the renal biopsy tissue were correlated with the pathologic classification of DN. Tubulointerstitial AT1R expression in patients of class IIb was significantly stronger than control samples ( p  < 0.05). Expression of AT2R and MAS receptors were highest with class IIb DN patients. When DN patients were treated with AT1R blocker (ARB), the expression of AT1R was downregulated ( p  < 0.05), and the MAS receptor was upregulated in tubular interstitial ( p  < 0.05).
CONCLUSIONS


Our results directly observed that renal expression levels of AT1R increase during the early stages of DN, ARB reducing AT1R while increasing MAS receptor. Therefore, ARB should be used as soon as possible in patients with DN.",2020,Tubulointerstitial AT1R expression in patients of class IIb was significantly stronger than control samples ( p  < 0.05).,"['115 patients diagnosed with DN by renal biopsy', 'human type 2 diabetic nephropathy (DN', 'patients with DN', 'patients with diabetic nephropathy']","['Angiotensin II type 1 receptor blockers', 'angiotensin II type 1 receptor (AT1R), angiotensin II type 2 receptor (AT2R), and MAS receptor', 'AT1R blocker (ARB']","['MAS receptor', 'protein expression levels of the AT1R, AT2R, and MAS receptors', 'Expression of AT2R and MAS receptors', 'renal angiotensin II and MAS receptor expression', 'expression of AT1R', 'Tubulointerstitial AT1R expression', 'protein expression levels of AT1R, AT2R, and MAS receptor in the renal biopsy tissue', 'renal expression levels of AT1R increase']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C1449680', 'cui_str': 'Angiotensin II Type 1 Receptor Antagonists'}, {'cui': 'C0529330', 'cui_str': 'Angiotensin Type 1 Receptor'}, {'cui': 'C0390423', 'cui_str': 'Angiotensin II Type 2 Receptor'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]","[{'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0529330', 'cui_str': 'Angiotensin Type 1 Receptor'}, {'cui': 'C0390423', 'cui_str': 'Angiotensin II Type 2 Receptor'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",115.0,0.0140806,Tubulointerstitial AT1R expression in patients of class IIb was significantly stronger than control samples ( p  < 0.05).,"[{'ForeName': 'Ye-Ping', 'Initials': 'YP', 'LastName': 'Ma', 'Affiliation': 'Clinical Medicine School of China-Japan friendship, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Shi-Min', 'Initials': 'SM', 'LastName': 'Jiang', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yi-Ning', 'Initials': 'YN', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Gu-Ming', 'Initials': 'GM', 'LastName': 'Zou', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Wen-Ge', 'Initials': 'WG', 'LastName': 'Li', 'Affiliation': 'Clinical Medicine School of China-Japan friendship, Peking Union Medical College, Beijing, China.'}]",Journal of the renin-angiotensin-aldosterone system : JRAAS,['10.1177/1470320320919607']
145,31806129,Echocardiographic Features of Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction.,"BACKGROUND


The PARAGON-HF (Prospective Comparison of ARNI With ARB Global Outcomes in HF With Preserved Ejection Fraction) trial tested the efficacy of sacubitril-valsartan in patients with heart failure with preserved ejection fraction (HFpEF). Existing data on cardiac structure and function in patients with HFpEF suggest significant heterogeneity.
OBJECTIVES


The aim of this study was to characterize cardiac structure and function, quantify their associations with clinical outcomes, and contextualize these findings with other HFpEF studies.
METHODS


Echocardiography was performed in 1,097 of 4,822 PARAGON-HF patients within 6 months of enrollment. Associations with incident first heart failure hospitalization or cardiovascular death were assessed using Cox proportional hazards models adjusted for age, sex, region of enrollment, randomized treatment, N-terminal pro-brain natriuretic peptide, and clinical risk factors.
RESULTS


Average age was 74 ± 8 years, 53% of patients were women, median N-terminal pro-brain natriuretic peptide level was 918 pg/ml (interquartile range: 485 to 1,578 pg/ml), 94% had hypertension, and 35% had atrial fibrillation. The mean left ventricular (LV) ejection fraction was 58.6 ± 9.8%, prevalence of LV hypertrophy was 21%, prevalence of left atrial enlargement was 83%, prevalence of elevated E/e' ratio was 53%, and prevalence of pulmonary hypertension was 31%. Heart failure hospitalization or cardiovascular death occurred in 288 patients at 2.8-year median follow-up. In fully adjusted models, higher LV mass index (hazard ratio [HR]: 1.05 per 10 g/m 2 ; 95% confidence interval [CI]: 1.00 to 1.10; p = 0.03), E/e' ratio (HR: 1.04 per unit; 95% CI: 1.02 to 1.06; p < 0.001), pulmonary artery systolic pressure (HR: 1.51 per 10 mm Hg; 95% CI: 1.29 to 1.76; p < 0.001), and right ventricular end-diastolic area (HR: 1.04 per cm 2 ; 95% CI: 1.01 to 1.07; p = 0.003) were each associated with this composite, while LV ejection fraction and left atrial size were not (p > 0.05 for all). Appreciable differences were observed in cardiac structure compared with other HFpEF clinical trials, despite similar E/e' ratio, pulmonary artery systolic pressure, and event rates.
CONCLUSIONS


Diastolic dysfunction, left atrial enlargement, and pulmonary hypertension were common in PARAGON-HF. LV hypertrophy, elevated left- and right-sided pressures, and right ventricular enlargement were independently predictive of incident heart failure hospitalization or cardiovascular death. Echocardiographic differences among HFpEF trials despite similar clinical event rates highlight the heterogeneity of this syndrome. (Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF]; NCT01920711).",2019,"Appreciable differences were observed in cardiac structure compared with other HFpEF clinical trials, despite similar E/e' ratio, pulmonary artery systolic pressure, and event rates.
","['patients with HFpEF', '288 patients at 2.8-year median follow-up', 'Echocardiography was performed in 1,097 of 4,822 PARAGON-HF patients within 6\xa0months of enrollment', 'patients with heart failure with preserved ejection fraction (HFpEF', 'Patients\xa0With Heart\xa0Failure and Preserved', 'Average age was 74 ± 8 years, 53% of patients were women, median N-terminal pro-brain natriuretic peptide level was 918 pg/ml (interquartile range: 485 to 1,578 pg/ml), 94% had hypertension, and 35% had atrial fibrillation', 'Heart\xa0Failure Patients With Preserved Ejection Fraction [PARAGON-HF']","['LCZ696', 'sacubitril-valsartan', 'Valsartan', 'HF']","['pulmonary hypertension', 'pulmonary artery systolic pressure', 'Heart failure hospitalization or cardiovascular death', 'cardiac structure', 'cardiovascular death', 'Diastolic dysfunction, left atrial enlargement, and pulmonary hypertension', 'prevalence of left atrial enlargement', 'prevalence of LV hypertrophy', 'LV hypertrophy, elevated left- and right-sided pressures, and right ventricular enlargement', 'right ventricular end-diastolic area', 'Morbidity and Mortality', 'mean left ventricular (LV) ejection fraction', ""E/e' ratio, pulmonary artery systolic pressure, and event rates"", 'LV ejection fraction and left atrial size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0616412', 'cui_str': 'paragon'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1533071', 'cui_str': 'N terminal pro-brain natriuretic peptide level'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0232309', 'cui_str': 'Left atrial hypertrophy by EKG'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0149721', 'cui_str': 'Left ventricular hypertrophy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162770', 'cui_str': 'Right ventricular hypertrophy'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.252585,"Appreciable differences were observed in cardiac structure compared with other HFpEF clinical trials, despite similar E/e' ratio, pulmonary artery systolic pressure, and event rates.
","[{'ForeName': 'Amil M', 'Initials': 'AM', 'LastName': 'Shah', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: ashah11@rics.bwh.harvard.edu.""}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Cikes', 'Affiliation': 'University of Zagreb School of Medicine and University Hospital Centre Zagreb, Department for Cardiovascular Diseases, Zagreb, Croatia.'}, {'ForeName': 'Narayana', 'Initials': 'N', 'LastName': 'Prasad', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Guichu', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Stoyan', 'Initials': 'S', 'LastName': 'Getchevski', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Rizkala', 'Affiliation': 'Novartis, East Hanover, New Jersey.'}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Lukashevich', 'Affiliation': 'Novartis, East Hanover, New Jersey.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Montreal Heart Institute and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Ryan', 'Affiliation': 'University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Mullens', 'Affiliation': 'Ziekenhuis Oost Limburg, Genk, Belgium.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'The Medical University of South Carolina and the Ralph H. Johnson VA Medical Center, Charleston, South Carolina.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore and Duke-National University of Singapore, Singapore; University Medical Centre Groningen, Groningen, the Netherlands; The George Institute for Global Health, Newtown, New South Wales, Australia.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.063']
146,32311655,Randomized sketches for kernel CCA.,"Kernel canonical correlation analysis (KCCA) is a popular tool as a nonlinear extension of canonical correlation analysis. Consistency and optimal convergence rate have been established in the literature. However, the time complexity of KCCA scales as O(n 3 ) and is thus prohibitive when n is large. We propose an m-dimensional randomized sketches approach for KCCA with m<<n, based on the recent work on randomized sketches for kernel ridge regression (KRR). Technically we establish our theoretical results relying on an interesting connection between KCCA and KRR by utilizing a novel ""duality tracking"" device that alternates between the infinite-dimensional operator-theory-based view of KCCA and the finite-dimensional kernel-matrix-based view.",2020,"However, the time complexity of KCCA scales as O(n 3 ) and is thus prohibitive when n is large.",[],['Kernel canonical correlation analysis (KCCA'],[],[],"[{'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],,0.045723,"However, the time complexity of KCCA scales as O(n 3 ) and is thus prohibitive when n is large.","[{'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Lian', 'Affiliation': 'Department of Mathematics, City University of Hong Kong, Hong Kong; City University of Hong Kong Shenzhen Research Institute, Shenzhen, China. Electronic address: henglian@cityu.edu.hk.'}, {'ForeName': 'Fode', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Center of Statistical Research and School of Statistics, Southwestern University of Finance and Economics, Chengdu, 611130, China.'}, {'ForeName': 'Wenqi', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'School of Management, Fudan University, Shanghai, China; Department of Mathematics, City University of Hong Kong, Hong Kong.'}]",Neural networks : the official journal of the International Neural Network Society,['10.1016/j.neunet.2020.04.006']
147,32374623,NUC-1031/cisplatin versus gemcitabine/cisplatin in untreated locally advanced/metastatic biliary tract cancer (NuTide:121).,"Gemcitabine/cisplatin is standard of care for first-line treatment of patients with advanced biliary tract cancer (aBTC); new treatments are needed. NUC-1031 is designed to overcome key cancer resistance mechanisms associated with gemcitabine. The tolerability/efficacy signal of NUC-1031/cisplatin in the Phase Ib ABC-08 study suggested that this combination may represent a more efficacious therapy than gemcitabine/cisplatin for patients with aBTC, leading to initiation of the global NuTide:121 study which will include 828 patients ≥18 years with untreated histologically/cytologically-confirmed aBTC (including cholangiocarcinoma, gallbladder or ampullary cancer); randomized (1:1) to NUC-1031 (725 mg/m 2 )/cisplatin (25 mg/m 2 ) or gemcitabine (1000 mg/m 2 )/cisplatin (25 mg/m 2 ), on days 1/8, Q21-days. Primary objectives are overall survival and objective response rate. Secondary objectives: progression-free survival, safety, pharmacokinetics, patient-reported quality of life and correlative studies.  (Investigational new drug (IND) number : 139058,  European Clinical Trials database : EudraCT Number 2019-001025-28,  ClinicalTrials.gov identifier : NCT04163900).",2020,The tolerability/efficacy signal of NUC-1031/cisplatin in the Phase,"['828 patients ≥18\xa0years with untreated histologically/cytologically-confirmed aBTC (including cholangiocarcinoma, gallbladder or ampullary cancer', 'patients with advanced biliary tract cancer (aBTC', 'untreated locally advanced/metastatic biliary tract cancer (NuTide:121', 'patients with aBTC']","['NUC-1031/cisplatin versus gemcitabine/cisplatin', 'Gemcitabine/cisplatin', 'cisplatin', 'gemcitabine', 'NUC-1031', 'NUC-1031 ', 'gemcitabine/cisplatin', 'NUC-1031/cisplatin']","['overall survival and objective response rate', 'progression-free survival, safety, pharmacokinetics, patient-reported quality of life and correlative studies', 'tolerability/efficacy signal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0262401', 'cui_str': 'Carcinoma of ampulla of Vater'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C3640933', 'cui_str': 'NUC-1031'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",828.0,0.0875217,The tolerability/efficacy signal of NUC-1031/cisplatin in the Phase,"[{'ForeName': 'Mairéad Geraldine', 'Initials': 'MG', 'LastName': 'McNamara', 'Affiliation': 'Division of Cancer Sciences, The University of Manchester & The Christie NHS Foundation Trust, Manchester, M20 4BX, UK.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Goyal', 'Affiliation': 'Department of Medical Oncology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Doherty', 'Affiliation': 'Department of Medical Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, M4Y 1H1, Canada.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Springfeld', 'Affiliation': 'Heidelberg University Hospital, Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Comp Cancer Center, The Johns Hopkins Hospital, Baltimore, MD 21287, USA.'}, {'ForeName': 'Katrin Marie', 'Initials': 'KM', 'LastName': 'Sjoquist', 'Affiliation': 'NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Joon Oh', 'Initials': 'JO', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of (South) Korea.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Verdaguer', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Braconi', 'Affiliation': 'The University of Glasgow & the Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Ross', 'Affiliation': ""Department of Medical Oncology, Guy's Hospital, London, UK.""}, {'ForeName': 'Aimery De', 'Initials': 'A', 'LastName': 'Gramont', 'Affiliation': 'Department of Medical Oncology, Franco-British Institute, Levallois-Perret, France.'}, {'ForeName': 'John Raymond', 'Initials': 'JR', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Medical Oncology, Alfred Health & School of Public Health, Monash University, Melbourne, Australia.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'Department of Medical Oncology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences, The University of Manchester & The Christie NHS Foundation Trust, Manchester, M20 4BX, UK.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Knox', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.'}]","Future oncology (London, England)",['10.2217/fon-2020-0247']
148,32376110,"Immunogenicity, long term protection and safety of subcutaneous administration of hepatitis A vaccine in patients with hemophilia and other bleeding disorders: A randomized study.","Hepatitis A vaccine is recommended for all individuals with hemophilia, although patients with bleeding disorders should avoid intramuscular (IM) injections. To date, only few studies showed subcutaneous (SC) route immunogenicity is comparable with the IM route. Therefore, this randomized study compared immunogenicity, long term protection and safety of hepatitis A vaccine administered by SC route with the IM route in 78 children and adults with hemophilia and other bleeding disorders. Thirty-eight patients had serology performed after first vaccine dose, determining seroconversion rates of 83.3% and 90.0% for the SC and the IM group, respectively (p = 0.5). Median IgG CO/OD value for the SC group was almost the double compared with the IM group (4.4 vs 2.6, p = 0.2). After second vaccine dose, seroconversion rates for the SC group was 97.5% and for the IM group was 97.4% (p = 1.0). Of the two patients who did not have seroconversion, interval between vaccine dose and serology was only one and two days for the SC and the IM group, respectively and in the following routine antibody dosage they presented seroconversion (100% for both groups). Median IgG CO/OD value for the SC group was greater than the IM group (72.5 vs. 58.0, p = 0.2). In a median of nine years after second vaccine dose, median IgG S/CO value for the SC group was slightly greater than the IM group (7.6 vs. 7.4, p = 0.8). There were no serious adverse events in both groups. Five (12.5%) patients of the SC group and seven (18.4%) of the IM group presented adverse events (p = 0.5). Twice as many patients of the IM group had clotting factor concentrates need for adverse events (15.8% vs. 7.5%, p = 0.3). Therefore, hepatitis A vaccine administered subcutaneously is as immunogenic, long term protective and even safer than the intramuscular route.",2020,"After second vaccine dose, seroconversion rates for the SC group was 97.5% and for the IM group was 97.4% (p = 1.0).","['78 children and adults with hemophilia and other bleeding disorders', 'individuals with hemophilia, although patients with bleeding disorders', 'patients with hemophilia and other bleeding disorders']","['hepatitis A vaccine', 'subcutaneous administration of hepatitis A vaccine']","['seroconversion rates', 'Median IgG CO/OD value', 'serious adverse events', 'adverse events', 'median IgG S/CO value', 'clotting factor concentrates need for adverse events', 'Immunogenicity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}]","[{'cui': 'C0170300', 'cui_str': 'Hepatitis A Vaccine'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005789', 'cui_str': 'Blood clotting factor'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",78.0,0.0424817,"After second vaccine dose, seroconversion rates for the SC group was 97.5% and for the IM group was 97.4% (p = 1.0).","[{'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Nakasone', 'Affiliation': 'Unidade de Hematologia, Instituto da Criança, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marta Heloisa', 'Initials': 'MH', 'LastName': 'Lopes', 'Affiliation': 'Departamento de Moléstias Infecciosas e Parasitárias, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ana Marli Chritovam', 'Initials': 'AMC', 'LastName': 'Sartori', 'Affiliation': 'Departamento de Moléstias Infecciosas e Parasitárias, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Eliane Partite Nobre', 'Initials': 'EPN', 'LastName': 'Sandoval', 'Affiliation': 'Centro de Hemofilia, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Paula Ribeiro', 'Initials': 'PR', 'LastName': 'Villaça', 'Affiliation': 'Centro de Hemofilia, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Elbio Antonio', 'Initials': 'EA', 'LastName': ""D'Amico"", 'Affiliation': 'Centro de Hemofilia, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jorge David Aivazoglou', 'Initials': 'JDA', 'LastName': 'Carneiro', 'Affiliation': 'Unidade de Hematologia, Instituto da Criança, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil; Centro de Hemofilia, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil. Electronic address: jorge.carneiro@hc.fm.usp.br.'}]",Vaccine,['10.1016/j.vaccine.2020.04.040']
149,32378273,"Effects of a cream containing madecassoside, 5% panthenol, and copper-zinc-manganese on improving postlaser resurfacing wound healing: A split-face, randomized trial.",,2020,,['post-laser resurfacing wound healing'],"['cream containing madecassoside, 5% panthenol, and copper-zinc-manganese']",[],"[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0297253', 'cui_str': 'madecassoside'}, {'cui': 'C1321598', 'cui_str': 'Panthenol'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0024706', 'cui_str': 'Manganese'}]",[],,0.0411193,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': ""L'Oreal (China) Co., Ltd., Shanghai, China.""}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Zhongxin', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Congying', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Zongzhou', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}]",Dermatologic therapy,['10.1111/dth.13533']
150,32376477,Effects of progressive resistance training prior to total HIP arthroplasty - a secondary analysis of a randomized controlled trial.,"OBJECTIVE


To investigate 1-year postoperative effect of preoperative resistance training (RT) in patients undergoing total hip arthroplasty (THA) on patient-reported outcomes on activity and function and objective outcomes on muscle strength and physical performance.
DESIGN


A 3-12 months follow-up of a randomized controlled trial. Patients scheduled for THA were randomized into: RT-group, twice a week for 10 weeks prior to THA, or 'care-as-usual' (CG). Primary endpoint of this sequel analysis is HOOS-ADL at 12 months follow-up. Secondary outcome measures are; other HOOS subscales, knee- and hip muscle strength plus function (gait, ascending/descending stairs, and sit-to-stand) at three and/or 12 months. CLINICALTRIALS.GOV: NCT01164111.
RESULTS


Eighty patients (70% women, 70.4 ± 7.6 years, BMI of 27.8 ± 4.6) were randomized to RT (n = 40) or CG (n = 40); data from 85% were available at 12 months. No superior effects were observed at 12 months for HOOS ADL (between-group change score [95%CI]) (2.6 [-4.2; 9.8], P = 0.44) or remaining subscales. However, ascending (1.3 s [0.3; 2.3], P = 0.01)) and descending stairs (1.6 s [0.3; 2.9], P = 0.01) demonstrated additional effects. At 3 months clinically relevant change-scores in favour of RT was observed on HOOS-Sport/Rec (10.5 points [1.4; 19.6], P = 0.023), together with higher knee strength of the affected side (14.6 Nm [6.3; 22.9], P < 0.001), and selected outcomes of physical function.
CONCLUSIONS


At 12 months after surgery, there was no additional effect of preoperative RT compared with THA alone, but rehabilitation was accelerated at 3 months.",2020,No superior effects were observed at 12 months for HOOS ADL (between-group change score [95%CI]) (,"['Patients scheduled for THA', 'patients undergoing total hip arthroplasty (THA', 'Eighty patients (70% women, 70.4 ± 7.6 years, BMI of 27.8 ± 4.6']","['THA', ""THA, or 'care-as-usual' (CG"", 'preoperative resistance training (RT', 'progressive resistance training']","['muscle strength and physical performance', 'HOOS subscales, knee- and hip muscle strength plus function (gait, ascending/descending stairs, and sit-to-stand', 'HOOS-ADL', 'knee strength', 'HOOS ADL']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517764', 'cui_str': '4.6'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",85.0,0.111012,No superior effects were observed at 12 months for HOOS ADL (between-group change score [95%CI]) (,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Holsgaard-Larsen', 'Affiliation': 'Orthopedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark. Electronic address: ahlarsen@health.sdu.dk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hermann', 'Affiliation': 'Orthopedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark; Department of Orthopedic Surgery, Herlev University Hospital, Denmark. Electronic address: ahermann@dadlnet.dk.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zerahn', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Herlev University Hospital, Denmark. Electronic address: Bo.Zerahn@regionh.dk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mejdahl', 'Affiliation': 'Department of Orthopedic Surgery, Herlev University Hospital, Denmark. Electronic address: Steen.Mejdahl@regionh.dk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Overgaard', 'Affiliation': 'Orthopedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark; Department of Clinical Research, University of Southern Denmark, Denmark. Electronic address: Soeren.Overgaard@rsyd.dk.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.04.010']
151,32376491,"Aeroallergen Sensitization, Serum IgE, and Eosinophilia as Predictors of Response to Omalizumab Therapy during the Fall Season among Children with Persistent Asthma.","BACKGROUND


Perennial aeroallergen sensitization is associated with greater asthma morbidity and is required for treatment with omalizumab.
OBJECTIVE


To investigate the predictive relationship between the number of aeroallergen sensitizations, total serum IgE, and serum eosinophil count, and response to omalizumab in children and adolescents with asthma treated during the fall season.
METHODS


This analysis includes inner-city patients with persistent asthma and recent exacerbations aged 6-20 years comprising the placebo and omalizumab-treated groups in two completed randomized clinical trials, the Inner-City Anti-IgE Therapy for Asthma (ICATA) study and the Preventative Omalizumab or Step-Up Therapy for Fall Exacerbations (PROSE) study. Logistic regression modeled the relationship between greater degrees of markers of allergic inflammation and the primary outcome of fall season asthma exacerbations.
RESULTS


The analysis included 761 participants who were 62% male and 59% African American with a median age of 10 years. Fall asthma exacerbations were significantly higher in children with greater numbers of aeroallergen-specific sensitizations in the placebo group (OR 1.33, 95% CI 1.11-1.60, p<0.01), but not in the omalizumab-treated children (OR 1.08, 95% CI 0.91-1.28, p=0.37) indicating a significant differential effect (p<0.01). Likewise, there was a differential effect of omalizumab treatment in children with greater baseline total serum IgE levels (p<0.01) or greater baseline serum eosinophil counts (p<0.01). Multiple aeroallergen sensitization was the best predictor of response to omalizumab; treated participants sensitized to ≥4 different groups of aeroallergens had a 51% reduction in the odds of a fall exacerbation (OR 0.49, 95% CI 0.30-0.81, p<0.01).
CONCLUSIONS


In preventing fall season asthma exacerbations, treatment with omalizumab was most beneficial in children with a greater degree of allergic inflammation.",2020,"Fall asthma exacerbations were significantly higher in children with greater numbers of aeroallergen-specific sensitizations in the placebo group (OR 1.33, 95% CI 1.11-1.60, p<0.01), but not in the omalizumab-treated children (OR 1.08, 95% CI 0.91-1.28, p=0.37) indicating a significant differential effect (p<0.01).","['city patients with persistent asthma and recent exacerbations aged 6-20 years comprising the', '761 participants who were 62% male and 59% African American with a median age of 10 years', 'children and adolescents with asthma treated during the fall season', 'Children with Persistent Asthma']","['Inner-City Anti-IgE Therapy for Asthma (ICATA) study and the Preventative Omalizumab or Step-Up Therapy', 'omalizumab', 'placebo and omalizumab']","['baseline total serum IgE levels', 'fall season asthma exacerbations', 'Aeroallergen Sensitization, Serum IgE, and Eosinophilia', 'allergic inflammation', 'Fall asthma exacerbations', 'fall exacerbation', 'total serum IgE, and serum eosinophil count, and response to omalizumab']","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0051978', 'cui_str': 'Anti-Immunoglobulin E antibody'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0001697', 'cui_str': 'Aeroallergen'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0014457', 'cui_str': 'Eosinophilia'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}]",761.0,0.144186,"Fall asthma exacerbations were significantly higher in children with greater numbers of aeroallergen-specific sensitizations in the placebo group (OR 1.33, 95% CI 1.11-1.60, p<0.01), but not in the omalizumab-treated children (OR 1.08, 95% CI 0.91-1.28, p=0.37) indicating a significant differential effect (p<0.01).","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sheehan', 'Affiliation': ""Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington, DC.""}, {'ForeName': 'Rebecca Z', 'Initials': 'RZ', 'LastName': 'Krouse', 'Affiliation': 'Rho, Federal Systems Division, Chapel Hill, NC.'}, {'ForeName': 'Agustin', 'Initials': 'A', 'LastName': 'Calatroni', 'Affiliation': 'Rho, Federal Systems Division, Chapel Hill, NC.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Gergen', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Rockville, MD.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Gern', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Gill', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Gruchalla', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Gurjit K', 'Initials': 'GK', 'LastName': 'Khurana Hershey', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Kattan', 'Affiliation': 'College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Kercsmar', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Carin I', 'Initials': 'CI', 'LastName': 'Lamm', 'Affiliation': 'College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Frederic F', 'Initials': 'FF', 'LastName': 'Little', 'Affiliation': 'Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Makhija', 'Affiliation': ""Lurie Children's Hospital and Northwestern University School of Medicine, Chicago, IL.""}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Searing', 'Affiliation': ""Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Zoratti', 'Affiliation': 'Henry Ford Health System and Wayne State University School of Medicine, Detroit, MI.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Teach', 'Affiliation': ""Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington, DC.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.03.051']
152,32381795,Effectiveness of Bubble Breath Play Therapy in the Dental Management of Anxious Children: A Pilot Study.,"Play is an inseparable part of childhood and can act as a mode through which children can be desensitized toward dental treatment.
AIM


To assess and compare the efficacy of bubble breath play therapy (BBPT) and tell-show-do (TSD) technique in the dental management of anxious/fearful children.
MATERIALS AND METHODS


Forty-eight children aged 6-8 years were randomly divided into group I: BBPT and group II: TSD. The effectiveness of the BBPT and TSD technique in reducing anxiety/fear in children was assessed pretreatment, during, and posttreatment evaluation of the child's anxiety levels using finger pulse oximeter and Venham's anxiety and behavior rating scale. All children underwent rotary restorative treatment.
RESULTS


The mean pulse rate in the BBPT and TSD group was 106.96 mm Hg and 102.25 mm Hg, respectively, at baseline. A decrease in the pulse rate was observed in both the groups after the application of behavior modification strategies. However, after the dental treatment, the mean pulse rate slightly increased in the BBPT group, while it showed a further improvement in the TSD group.
CONCLUSION


The BBPT acts as a distraction and can be considered to enhance rapport between the dentist and children during dental treatment.
CLINICAL SIGNIFICANCE


Application of appropriate strategies to allay dental fear in children is essential to provide quality dental treatment and build a positive attitude toward oral health.",2020,A decrease in the pulse rate was observed in both the groups after the application of behavior modification strategies.,"['anxious/fearful children', 'Anxious Children', 'Forty-eight children aged 6-8 years']","['bubble breath play therapy (BBPT) and tell-show-do (TSD) technique', 'rotary restorative treatment', 'Bubble Breath Play Therapy', 'BBPT', 'BBPT and TSD technique']","['pulse rate', ""child's anxiety levels using finger pulse oximeter and Venham's anxiety and behavior rating scale"", 'mean pulse rate slightly', 'mean pulse rate']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0032216', 'cui_str': 'Play therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0475483', 'cui_str': 'Behavior rating scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}]",48.0,0.0195124,A decrease in the pulse rate was observed in both the groups after the application of behavior modification strategies.,"[{'ForeName': 'Umme', 'Initials': 'U', 'LastName': 'Azher', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Sri Rajiv Gandhi College of Dental Sciences and Hospital, Bengaluru, Karnataka, India, Phone: +91 9945352984, e-mail: drummeazher@yahoo.com.'}, {'ForeName': 'Sarakanuru K', 'Initials': 'SK', 'LastName': 'Srinath', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Government Dental College and Research Institute, Victoria Hospital, Bengaluru, Karnataka, India.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Nayak', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Sri Rajiv Gandhi College of Dental Sciences and Hospital, Bengaluru, Karnataka, India.'}]",The journal of contemporary dental practice,[]
153,32316438,The Effects of Alcohol Hangover on Executive Functions.,"Recent research has suggested that processes reliant on executive functions are impaired by an alcohol hangover, yet few studies have investigated the effect of hangovers on core executive function processes. Therefore, the current study investigated the effect of hangovers on the three core components of the unity/diversity model of executive functions: the ability to switch attention, update information in working memory, and maintain goals. Thirty-five 18-to-30-year-old non-smoking individuals who reported experiencing a hangover at least once in the previous month participated in this study. They completed tasks measuring switching (number-switching task), updating (n-back task), and goal maintenance (AX Continuous Performance Test, AX-CPT) whilst experiencing a hangover and without a hangover in a 'naturalistic' within-subjects crossover design. Participants made more errors in the switching task ( p  = 0.019), more errors in both the 1- ( p  < 0.001) and 2-back ( p  < 0.001) versions of the n-back, and more errors in the AX-CPT ( p  = 0.007) tasks when experiencing a hangover, compared to the no-hangover condition. These results suggest that an alcohol hangover impairs core executive function processes that are important for everyday behaviours, such as decision-making, planning, and mental flexibility.",2020,"Participants made more errors in the switching task ( p  = 0.019), more errors in both the 1- ( p  < 0.001) and 2-back ( p  < 0.001) versions of the n-back, and more errors in the AX-CPT ( p  = 0.007) tasks when experiencing a hangover, compared to the no-hangover condition.",['Thirty-five 18-to-30-year-old non-smoking individuals who reported experiencing a hangover at least once in the previous month participated in this study'],[],['Executive Functions'],"[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0221100', 'cui_str': 'Hangover'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0197235,"Participants made more errors in the switching task ( p  = 0.019), more errors in both the 1- ( p  < 0.001) and 2-back ( p  < 0.001) versions of the n-back, and more errors in the AX-CPT ( p  = 0.007) tasks when experiencing a hangover, compared to the no-hangover condition.","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Gunn', 'Affiliation': 'Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath BA2 7AY, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Fairchild', 'Affiliation': 'Department of Psychology, University of Bath, Bath BA2 7AY, UK.'}, {'ForeName': 'Joris C', 'Initials': 'JC', 'LastName': 'Verster', 'Affiliation': 'Division of Pharmacology, Utrecht University, 3584CG Utrecht, The Netherlands.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Adams', 'Affiliation': 'Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath BA2 7AY, UK.'}]",Journal of clinical medicine,['10.3390/jcm9041148']
154,32380119,Exposure to harmful and potentially harmful constituents decreased in smokers switching to Carbon-Heated Tobacco Product.,"BACKGROUND


""Heat-not-burn"" tobacco products are designed to heat processed tobacco instead of combusting it, thus significantly reducing the formation of harmful and potentially harmful constituents (HPHCs) found in cigarette smoke, and ultimately reducing the risk of smoking-related diseases. The Carbon-Heated Tobacco Product (CHTP), a heat-not-burn tobacco product similar in appearance and use ritual to cigarettes, has been developed for smokers who would otherwise continue smoking as an alternative to cigarettes. To evaluate reduced risk of harm potential of CHTP, it is critical to quantify exposure to HPHCs and consequent biological pathway disturbances involved in disease onset in smokers who switch to CHTP.
METHODS


In this 2-arm, parallel-group study, adult healthy smokers, not willing to quit, were randomized to switch to CHTP 1.2 (n = 80) or to continue using cigarettes (n = 40) for 5 days in confinement followed by 85 days in an ambulatory setting. Endpoints included biomarkers of exposure (BoExp) to HPHCs, and to nicotine, urinary excretion of mutagenic constituents (Ames assay), CYP1A2 activity, biomarkers of effect, and safety.
RESULTS


In switchers to CHTP, BoExp were 40%-95% lower compared to smokers after 5 days of product use, with sustained reductions (36%-93%) observed on Day 90. Urine mutagenicity and CYP1A2 activity were also lower in the CHTP group. Exposure to nicotine was higher in the CHTP group at Day 5, but was similar between the two groups at Day 90. Favorable changes in some biomarkers of effect were observed in the CHTP group showing reductions in white blood cell count, soluble intracellular adhesion molecule-1, and 11-dehydro-thromboxane B2, respectively, indicative of reduced inflammation, endothelial dysfunction, and platelet activation.
CONCLUSIONS


Switching from cigarettes to CHTP resulted in significantly reduced exposure to HPHCs and was associated with observed improvements in some biomarkers of effect representative of pathomechanistic pathways underlying the development of smoking-related diseases.",2020,"Exposure to nicotine was higher in the CHTP group at Day 5, but was similar between the two groups at Day90.","['smokers who switch to CHTP', 'adult healthy smokers, not willing to quit']","['CHTP', 'Carbon-Heated Tobacco Product (CHTP']","['white blood cell count, soluble intracellular adhesion molecule-1, and 11-dehydro-thromboxane B2 respectively indicative of reduced inflammation, endothelial dysfunction, and platelet activation', 'biomarkers of exposure (BoExp) to HPHCs, and to nicotine, urinary excretion of mutagenic constituents (Ames assay), CYP1A2 activity, biomarkers of effect, and safety', 'Urine mutagenicity and CYP1A2 activity']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0600109', 'cui_str': 'Willing'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]","[{'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0044728', 'cui_str': '11-dehydro-thromboxane B2'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0207509', 'cui_str': 'Cytochrome p450 CYP1A2 enzyme'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042036', 'cui_str': 'Urine'}]",,0.0196296,"Exposure to nicotine was higher in the CHTP group at Day 5, but was similar between the two groups at Day90.","[{'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Bosilkovska', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland. Electronic address: Marija.Bosilkovska@contracted.pmi.com.'}, {'ForeName': 'Cam Tuan', 'Initials': 'CT', 'LastName': 'Tran', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'de La Bourdonnaye', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Brindusa', 'Initials': 'B', 'LastName': 'Taranu', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Benzimra', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Haziza', 'Affiliation': 'Philip Morris International, Philip Morris Products, S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.'}]",Toxicology letters,['10.1016/j.toxlet.2020.04.013']
155,32380135,Measurement of eroded dentine tubule patency and roughness following novel dab-on or brushing abrasion.,"OBJECTIVES


To investigate the effect of dab-on or brushing of stannous-fluoride SnF2 or sodium-fluoride NaF dentifrice on eroded dentine tubule patency, surface and inter-tubular dentine roughness, using Confocal-Laser-Scanning-Microscopy (CLSM), Atomic-Force-Microscopy (AFM), Energy-Dispersive-X-ray-Spectroscopy (EDX), Scanning-Electron-Microscopy (SEM) and Contact-Profilometry (CP).
METHODS


75-polished human dentine samples were prepared and eroded in agitated 6% citric acid to expose patent tubules and 'initiate' DH. Samples were randomly allocated into 5 intervention groups; artificial saliva control (1); electric tooth-brushing with NaF (2) or SnF2 (3), and dab-on application of NaF (4) or SnF2 (5). Samples underwent three cycles of intervention followed by further acid challenge. Patent tubules, likely to cause DH clinically, were measured using validated biocomputational methods with CLSM images of dentine surfaces taken baseline and post-intervention. Randomised samples (n = 15, 20 %) were investigated using AFM, EDX and SEM to study surface and sub-surface tubular occlusion. Dentine surface and inter-tubular roughness were measured using CP and AFM respectively.
RESULTS


At baseline, mean tubule patency in all samples was 216 (SD 58) with no significant inter-group differences. Post-intervention, the mean patency was 220 (40) and 208 (35) in groups 1 and 2 respectively (p ≥ 0.06), but decreased to 62 (41), 62 (21) and 63 (19) in groups 3, 4 and 5 respectively (p < 0.0001). Patency was confirmed using AFM, SEM and EDX. SnF2 interventions created greater sub-surface occlusion (p < 0.01), and increased CP surface roughness (p = 0.015). Significant negative correlation (-0.6) existed between CP surface roughness and tubule patency (p = 0.009).
CONCLUSIONS


Dab-on with NaF and SnF2 or brushing with SnF2 reduces DH in eroded dentine with ongoing acid challenges. Contacting surface roughness measures indicate risk of DH.
CLINICAL SIGNIFICANCE


Dab-on is a convenient supplementary method of dentifrice application to reduce DH; it beneficially avoids brushing post-erosion or overzealous brushing, enables re-establishment of an appropriate brushing regime post-DH and supports oral health. Significant modes of action of SnF2 in reducing DH are revealed. Finally, CP roughness measures provide indication of dentine lesions that may cause DH clinically.",2020,"SnF2 interventions created greater sub-surface occlusion (p < 0.01), and CP surface roughness (p = 0.015).",['75-polished human dentine samples were prepared and eroded in agitated 6'],"[""citric acid to expose patent tubules and 'initiate' DH"", 'NaF dentifrice', 'stannous-fluoride SnF2 or sodium-fluoride', 'artificial saliva control (1); electric tooth-brushing with NaF (2) or SnF2 (3), and dab-on application of NaF (4) or SnF2 (5']","['CP surface roughness and tubule patency', 'mean patency', 'eroded dentine tubule patency, surface and inter-tubular dentine roughness, using Confocal-Laser-Scanning-Microscopy (CLSM), Atomic-Force-Microscopy (AFM), Energy-Dispersive-X-ray-Spectroscopy (EDX), Scanning-Electron-Microscopy (SEM) and Contact-Profilometry (CP', 'sub-surface occlusion', 'mean tubule patency', 'CP surface roughness', 'Dentine surface and inter-tubular roughness']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0059735', 'cui_str': 'Cytochrome p450 CYP1A1 enzyme'}]","[{'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0012411', 'cui_str': '4-dimethylaminoazobenzene'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0059735', 'cui_str': 'Cytochrome p450 CYP1A1 enzyme'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0242841', 'cui_str': 'Confocal Laser Scanning Microscopy'}, {'cui': 'C0242849', 'cui_str': 'Atomic Force Microscopy'}, {'cui': 'C2699997', 'cui_str': 'Energy Dispersive X-Ray Fluorescence Spectroscopy'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",,0.0311758,"SnF2 interventions created greater sub-surface occlusion (p < 0.01), and CP surface roughness (p = 0.015).","[{'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Olley', 'Affiliation': 'Cardiff University, School of Dentistry, University Hospital Wales, Heath Park, Cardiff CF14 4XY, UK; Faculty of Dentistry, Oral and Craniofacial Sciences, Kings College London, London, UK. Electronic address: olleyr1@cardiff.ac.uk.'}, {'ForeName': 'Basim M', 'Initials': 'BM', 'LastName': 'Mohsen', 'Affiliation': 'Dental School, University of Dundee, Dundee, UK. Electronic address: bmmohsen1@sheffield.ac.uk.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Alhaij', 'Affiliation': 'Dental School, University of Dundee, Dundee, UK. Electronic address: s.alhaij@dundee.ac.uk.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Appleton', 'Affiliation': 'School of Life Sciences, University of Dundee, Dundee, UK. Electronic address: P.L.Appleton@dundee.ac.uk.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103358']
156,32380894,Functional respiratory imaging assessment of glycopyrrolate and formoterol fumarate metered dose inhalers formulated using co-suspension delivery technology in patients with COPD.,"BACKGROUND


Functional respiratory imaging (FRI) is a quantitative postprocessing imaging technique used to assess changes in the respiratory system. Using FRI, we characterized the effects of the long-acting muscarinic antagonist (LAMA), glycopyrrolate metered dose inhaler (GP MDI), and the long-acting β 2 -agonist (LABA), formoterol fumarate metered dose inhaler (FF MDI), on airway volume and resistance in patients with moderate-to-severe chronic obstructive pulmonary disease.
METHODS


Patients in this phase IIIb, randomized, double-blind crossover study received twice-daily GP MDI (18 μg) and FF MDI (9.6 μg). Primary endpoints were specific (i.e. corrected for lobar volume) image-based airway volume (siVaw) and specific image-based airway resistance (siRaw), measured using FRI. Secondary and other endpoints included additional FRI, spirometry, and body plethysmography parameters. Postdose efficacy assessments were performed within 60-150 min of dosing on day 15.
RESULTS


A total of 23 patients were randomized and 19 completed both treatment periods. GP MDI and FF MDI both achieved significant improvements from baseline to day 15 in siVaw [11% ( p  = 0.0187) and 23% ( p  < 0.0001) increases, respectively] and siRaw [25% ( p  = 0.0219) and 44% ( p  < 0.0001) reductions, respectively]. Although, on average, improvements were larger for FF MDI than GP MDI, some individuals displayed greater responses with each of the two treatments. These within-patient differences increased with airway generation number. Spirometry and body plethysmography endpoints showed significant improvements from baseline in inspiratory capacity for both treatments, and numeric improvements for other endpoints.
CONCLUSION


Both GP MDI and FF MDI significantly improved siRaw and siVaw at day 15  versus  baseline. FRI endpoints demonstrated increased sensitivity relative to spirometry and body plethysmography in detecting differences between treatments in a small number of patients. Intra-patient differences in treatment response between the LAMA and the LABA provide further support for the benefit of dual bronchodilator therapies.
CLINICALTRIALS.GOV REGISTRATION NUMBER


NCT02937584  The reviews of this paper are available via the supplemental material section.",2020,"Spirometry and body plethysmography endpoints showed significant improvements from baseline in inspiratory capacity for both treatments, and numeric improvements for other endpoints.
","['patients with moderate-to-severe chronic obstructive pulmonary disease', 'Patients in this phase IIIb', 'patients with COPD', '23 patients']","['muscarinic antagonist (LAMA), glycopyrrolate metered dose inhaler (GP MDI), and the long-acting β 2 -agonist (LABA), formoterol fumarate metered dose inhaler (FF MDI', 'Functional respiratory imaging (FRI', 'twice-daily GP MDI', 'glycopyrrolate and formoterol fumarate', 'GP MDI and FF MDI']","['specific (i.e. corrected for lobar volume) image-based airway volume (siVaw) and specific image-based airway resistance (siRaw), measured using FRI', 'siRaw', 'additional FRI, spirometry, and body plethysmography parameters', 'sensitivity relative to spirometry and body plethysmography', 'inspiratory capacity', 'siRaw and siVaw', 'GP MDI and FF MDI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0032224', 'cui_str': 'Total body plethysmography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}]",23.0,0.283185,"Spirometry and body plethysmography endpoints showed significant improvements from baseline in inspiratory capacity for both treatments, and numeric improvements for other endpoints.
","[{'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'De Backer', 'Affiliation': 'University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, Wilrijk, 2610 Antwerp, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'De Backer', 'Affiliation': 'FLUIDDA, Inc, Los Angeles, CA, USA.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verlinden', 'Affiliation': 'Formerly of FLUIDDA NV, Kontich, Belgium.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Leemans', 'Affiliation': 'Formerly of FLUIDDA NV, Kontich, Belgium.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Van Holsbeke', 'Affiliation': 'FLUIDDA NV, Kontich, Belgium.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mignot', 'Affiliation': 'FLUIDDA NV, Kontich, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Jenkins', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Griffis', 'Affiliation': 'AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ivanov', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Fitzpatrick', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}, {'ForeName': 'Earl', 'Initials': 'E', 'LastName': 'St Rose', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}, {'ForeName': 'Ubaldo J', 'Initials': 'UJ', 'LastName': 'Martin', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reisner', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620916990']
157,32393193,Neuroprotective effects of exercise in people with progressive multiple sclerosis (Exercise PRO-MS): study protocol of a phase II trial.,"BACKGROUND


Neurodegeneration, rather than inflammation, plays a key role in the progressive phase of multiple sclerosis (MS). Current disease modifying treatment options for people with progressive MS (PMS) do not specifically target neurodegeneration. Preliminary evidence suggests that exercise therapy might have neuroprotective effects. However, neuroprotective effect studies of exercise interventions in PMS are scarce and the possible mode of action underlying neuroprotective effects of exercise are unknown and need to be elucidated. The main aim of this phase II trial is to assess whether progressive resistance training (PRT) and high intensity interval training (HIIT), can slow down neurodegeneration in people with PMS.
METHODS


In a single-blinded phase II clinical trial with an extended baseline period, 60 people with PMS will be randomly assigned to PRT or HIIT. The participants should have had a relapse onset of MS with confirmed disease progression, however still ambulatory. The duration of the study is 48 weeks, consisting of 16 weeks baseline period (no intervention), 16 weeks intervention and 16 weeks follow-up. Patient-tailored training will be performed 3 times per week for one hour in groups, led by an experienced physiotherapist. The primary outcome measure is neurodegeneration, measured as whole brain atrophy on magnetic resonance imaging (MRI). Secondary outcome parameters will include other biomarkers associated with neurodegeneration (i.e. regional brain atrophy, lesion load, white matter integrity, resting state functional connectivity, blood biomarkers (brain derived neurotrophic factor (BDNF) and serum neurofilament light (sNFL)), patient functioning (physical and cognitive) and cardiovascular risk factors.
DISCUSSION


Besides the primary outcome measures, this study will examine a large variety of biomarkers associated with neurodegeneration after an exercise intervention. Combining outcome parameters may help to elucidate the mode of action underlying neuroprotective effects of exercise.
TRIAL REGISTRATION


This trial is prospectively registered at the Dutch Trial Registry (number NL8265, date 06-01-2020).",2020,"Besides the primary outcome measures, this study will examine a large variety of biomarkers associated with neurodegeneration after an exercise intervention.","['people with PMS', '60 people with PMS', 'people with progressive multiple sclerosis (Exercise PRO-MS', 'people with progressive MS (PMS']","['exercise therapy', 'progressive resistance training (PRT) and high intensity interval training (HIIT', 'exercise']","['neurodegeneration, measured as whole brain atrophy on magnetic resonance imaging (MRI', 'biomarkers associated with neurodegeneration (i.e. regional brain atrophy, lesion load, white matter integrity, resting state functional connectivity, blood biomarkers (brain derived neurotrophic factor (BDNF) and serum neurofilament light (sNFL)), patient functioning (physical and cognitive) and cardiovascular risk factors']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0027746', 'cui_str': 'Nerve degeneration'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",60.0,0.173043,"Besides the primary outcome measures, this study will examine a large variety of biomarkers associated with neurodegeneration after an exercise intervention.","[{'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Gravesteijn', 'Affiliation': 'Department of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands. a.gravesteijn@amsterdamumc.nl.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Beckerman', 'Affiliation': 'Department of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'de Jong', 'Affiliation': 'Department of Neurology, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands.'}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Hulst', 'Affiliation': 'Department of Anatomy and Neurosciences, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'de Groot', 'Affiliation': 'Department of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands.'}]",BMC neurology,['10.1186/s12883-020-01765-6']
158,32393194,Experiences of maternity care in New South Wales among women with mental health conditions.,"BACKGROUND


High quality maternity care is increasingly understood to represent a continuum of care. As well as ensuring a positive experience for mothers and families, integrated maternity care is responsive to mental health needs of mothers. The aim of this paper is to summarize differences in women's experiences of maternity care between women with and without a self-reported mental health condition.
METHODS


Secondary analyses of a randomized, stratified sample patient experience survey of 4787 women who gave birth in a New South Wales public hospital in 2017. We focused on 64 measures of experiences of antenatal care, hospital care during and following birth and follow up at home. Experiences covered eight dimensions: overall impressions, emotional support, respect for preferences, information, involvement, physical comfort and continuity. Multivariable logistic regression was used to compare experiences of women with and without a self-reported longstanding mental health condition.
RESULTS


Compared to women without a condition, women with a longstanding mental health condition (n = 353) reported significantly less positive experiences by eight percentage points on average, with significant differences on 41 out of 64 measures after adjusting for age, education, language, parity, type of birth and region. Disparities were pronounced for key measures of emotional support (discussion of worries and fears, trust in providers), physical comfort (assistance, pain management) and overall impressions of care. Most women with mental health conditions (75% or more) reported positive experiences for measures related to guidelines for maternity care for women with mental illness (discussion of emotional health, healthy behaviours, weight gain). Their experiences were not significantly different from those of women with no reported conditions.
CONCLUSIONS


Women with a mental health condition had significantly less positive experiences of maternity care across all stages of care compared to women with no condition. However, for some measures, including those related to guidelines for maternity care for women with mental illness, there were highly positive ratings and no significant differences between groups. This suggests disparities in experiences of care for women with mental health conditions are not inevitable. More can be done to improve experiences of maternity care for women with mental health conditions.",2020,"Disparities were pronounced for key measures of emotional support (discussion of worries and fears, trust in providers), physical comfort (assistance, pain management) and overall impressions of care.","[""women's experiences of maternity care between women with and without a self-reported mental health condition"", 'women with mental health conditions', '4787 women who gave birth in a New South Wales public hospital in 2017', '64 measures of experiences of antenatal care, hospital care during and following birth and follow up at home', 'Women with a mental health condition']",['maternity care'],"['emotional support (discussion of worries and fears, trust in providers), physical comfort (assistance, pain management) and overall impressions of care', 'impressions, emotional support, respect for preferences, information, involvement, physical comfort and continuity', 'positive experiences of maternity care']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}]","[{'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}]",4787.0,0.0883294,"Disparities were pronounced for key measures of emotional support (discussion of worries and fears, trust in providers), physical comfort (assistance, pain management) and overall impressions of care.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Corscadden', 'Affiliation': 'Australian Institute of Tropical Health and Medicine, James Cook University, 1 James Cook Dr, Douglas, Queensland, 4811, Australia. lisa.corscadden@health.nsw.gov.au.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Callander', 'Affiliation': 'School of Medicine, Griffiths University, 170 Kessels Rd, Nathan, QLD, 4111, Australia.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Topp', 'Affiliation': 'College of Public Health, Medical & Veterinary Sciences, James Cook University, 1 James Cook Dr, Douglas, Queensland, 4811, Australia.'}, {'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Watson', 'Affiliation': 'Bureau of Health Information, Level 11, 67 Albert Avenue, Chatswood, NSW, 2067, Australia.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-02972-2']
159,32381807,Comparison of Efficacy of Topical Curcumin Gel with Triamcinolone-hyaluronidase Gel Individually and in Combination in the Treatment of Oral Submucous Fibrosis.,"AIM


To study the efficacy of topical curcumin mucoadhesive semisolid gel, triamcinolone acetonide/hyaluronidase mucoadhesive semisolid gel, and a combination of both in the treatment of oral submucous fibrosis (OSMF).
MATERIALS AND METHODS


One hundred and twenty patients diagnosed with OSMF were randomly divided into groups I, II, and III. Each patients in groups I, II, and III was given professionally prepared mucoadhesive semisolid gel of curcumin, a combination of triamcinolone acetonide and hyaluronidase mucoadhesive semisolid gel, and a combination of all three, respectively. Patients were instructed to apply the gel thrice daily for 6 weeks on buccal mucosa bilaterally using the tip of index finger. Three parameters were evaluated at the end of each week, namely, mouth opening, burning on visual analog scale (VAS), and the color of oral mucosa on the binary scale. The results were subjected to statistical analysis.
RESULTS


It was observed that the group administered the three drug combinations achieved the greatest mouth opening (mean increase 4.05 mm) as compared to the other two groups. It was observed that triamcinolone and hyaluronidase group reported reduction in burning sensation on VAS (mean difference 6) as compared to the other two groups. It was observed that group III (1% curcumin, 1% hyaluronidase and 0.1% triamcinolone acetonide combined) drug therapy showed better change in mucosa color as compared to groups I (1% curcumin) and II.
CONCLUSION


Thus, we can conclude that curcumin has a therapeutic effect on patients diagnosed with OSMF. Maximum utilization and enhanced drug delivery were achieved with the help of a combination other two active drugs, namely, triamcinolone and hyaluronidase.
CLINICAL SIGNIFICANCE


Curcumin role in the treatment of oral cancers and the precancer lesion is very promising.",2020,It was observed that triamcinolone and hyaluronidase group reported reduction in burning sensation on VAS (mean difference 6) as compared to the other two groups.,"['patients diagnosed with OSMF', 'Oral Submucous Fibrosis', 'One hundred and twenty patients diagnosed with OSMF', 'oral submucous fibrosis (OSMF']","['triamcinolone acetonide and hyaluronidase mucoadhesive semisolid gel', 'topical curcumin mucoadhesive semisolid gel, triamcinolone acetonide/hyaluronidase mucoadhesive semisolid gel', 'triamcinolone', 'Topical Curcumin Gel with Triamcinolone-hyaluronidase Gel', 'triamcinolone acetonide']","['Maximum utilization and enhanced drug delivery', 'greatest mouth opening ', 'change in mucosa color', 'namely, mouth opening, burning on visual analog scale (VAS), and the color of oral mucosa on the binary scale', 'burning sensation on VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029172', 'cui_str': 'Oral submucosal fibrosis'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0020197', 'cui_str': 'Hyaluronidase'}, {'cui': 'C1720454', 'cui_str': 'Semi-solid dose form'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0474492', 'cui_str': 'Color of oral mucosa'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}]",120.0,0.0124886,It was observed that triamcinolone and hyaluronidase group reported reduction in burning sensation on VAS (mean difference 6) as compared to the other two groups.,"[{'ForeName': 'Ashish B', 'Initials': 'AB', 'LastName': 'Lanjekar', 'Affiliation': 'Department of Oral Medicine and Radiology, Swargiya Dadasaheb Kalmegh Smruti Dental College, Nagpur, Maharashtra, India, Phone: +91 9595052481, e-mail: Ashishlanjekar2007@gmail.com.'}, {'ForeName': 'Rahul R', 'Initials': 'RR', 'LastName': 'Bhowate', 'Affiliation': 'Department of Oral Medicine and Radiology, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.'}, {'ForeName': 'Suparna', 'Initials': 'S', 'LastName': 'Bakhle', 'Affiliation': 'Department of Pharmaceutic, Priyadarshini JL College of Pharmacy, Nagpur, Maharashtra, India.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Narayane', 'Affiliation': 'Department of Prosthodontics and Crown and Bridge, Dr Hedgewar Smruti Rugna Seva Mandal Dental College and Hospital, Hingoli, Maharashtra, India.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Pawar', 'Affiliation': 'Department of Oral Pathology, Dr Hedgewar Smruti Rugna Seva Mandal Dental College and Hospital, Washim, Maharashtra, India.'}, {'ForeName': 'Ranjeet', 'Initials': 'R', 'LastName': 'Gandagule', 'Affiliation': 'Department of Prosthodontics, Dr Hedgewar Smruti Rugna Seva Mandal Dental College and Hospital, Hingoli, Maharashtra, India.'}]",The journal of contemporary dental practice,[]
160,32380239,Effects of Partial Sleep Deprivation on Braking Response of Drivers in Hazard Scenarios.,"This study aimed at modeling the Response Time (RT) and Total Braking Time (TBT) of drivers under Partial Sleep Deprivation (PSD). Fifty male participants drove the driving simulator in three experimental conditions: two test sessions and a baseline. The two test sessions were conducted after one and two nights of PSD (sleep = 4.25 ± 0.5 h), respectively. Sleep reduction was recorded using a wrist-worn Actiwatch. The baseline session was conducted after full rest (7-8 h sleep/day for a week). The order of test sessions and baseline was randomized. Each test included two hazard events: 1) pedestrians crossing a road and 2) parked vehicles merging into a roadway. Karolinska Sleepiness Scale (KSS) and Sleepiness Symptoms Questionnaire (SSQ) ratings were also recorded during each drive. Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events. The models were chosen with clustered heterogeneity to account for intra-group heterogeneity due to repeated measures across tests. In the case of pedestrians crossing event, RT increased by 10% in the first test session and no significant effect observed on RT in the second test session. The overall TBT reduced by 25% and 28% during the first and second PSD sessions, respectively. In the case of vehicle merging event, both response time and total braking time delayed by 44% and 17% respectively after PSD. Other factors such as age, experience, work-rest hours, KSS and SSQ rating, often exercising, approaching speed and braking force were also found significant in the analysis. The parametric AFT approach adopted in this study showed the change in 'response time' and 'total braking time' concerning the type of hazard scenario and partial sleep-deprivation.",2020,Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events.,"['Fifty male participants', 'Drivers in Hazard Scenarios']",['Partial Sleep Deprivation'],"['Sleep reduction', 'response time and total braking time delayed', 'pedestrians crossing a road and 2) parked vehicles merging into a roadway', 'Karolinska Sleepiness Scale (KSS) and Sleepiness Symptoms Questionnaire (SSQ) ratings', 'overall TBT', 'Response Time (RT) and Total Braking Time (TBT) of drivers under Partial Sleep Deprivation (PSD']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0450063', 'cui_str': 'Pedestrian'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]",50.0,0.023591,Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events.,"[{'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Mahajan', 'Affiliation': 'Transportation Systems Engineering, Department of Civil Engineering, Indian Institute of Technology (IIT) Bombay, Powai, Mumbai 400 076, India.'}, {'ForeName': 'Nagendra R', 'Initials': 'NR', 'LastName': 'Velaga', 'Affiliation': 'Transportation Systems Engineering, Department of Civil Engineering, Indian Institute of Technology (IIT) Bombay, Powai, Mumbai 400 076, India. Electronic address: n.r.velaga@iitb.ac.in.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105545']
161,32380260,Methodological and reporting issues in a randomised controlled trial: Comment on de la Fuente et al (2020).,,2020,,[],[],[],[],[],[],,0.0693986,,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Halloran"", 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Belfast BT9 7BL, United Kingdom. Electronic address: p.ohalloran@qub.ac.uk.""}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103585']
162,32380271,Efficacy of adjunctive infliximab vs. placebo in the treatment of anhedonia in bipolar I/II depression.,"We investigated the efficacy of tumour necrosis factor (TNF)-α antagonist infliximab on a measure of anhedonia amongst individuals with bipolar I/II depression (ClinicalTrials.gov identifier NCT02363738). Adults (ages 18-65) with bipolar I/II disorder currently experiencing a major depressive episode with a higher probability of inflammatory activity (i.e., meeting one or more of the following inflammatory/metabolic criteria: obesity and dyslipidemia/hypertension, daily cigarette smoking, diabetes mellitus, migraine, inflammatory bowel disease, and/or C-reactive protein level of ⩾5 mg/L) were enrolled in a double-blind, 12-week clinical trial of adjunctive infliximab (5 mg/kg) and saline control, which were administered at weeks 0, 2, and 6. The primary outcome measure for the present secondary analysis was change in the Snaith-Hamilton Pleasure Scale (SHAPS) total score between placebo- and infliximab-treated subjects from baseline to weeks 6 and 12. Plasma concentrations of TNF-α and soluble TNF receptors (sTNFR) 1 and 2 were assessed at weeks 0, 2, 6, and 12. Sixty eligible adults received treatment with infliximab (n=29) or placebo (n=31); 47 subjects completed the study (infliximab: n=21, placebo: n=26). Overall, infliximab-randomized subjects exhibited significantly larger increases in SHAPS total score, denoting greater reductions in anhedonic symptoms, when compared to placebo-randomized subjects (treatment × time interaction effect: χ 2 =7.15,df=2,p=0.03). Anti-anhedonic efficacy was moderated by baseline plasma levels of TNF-α and sTNFR1, but not by changes in TNF-α or sTNFR1 concentrations. Baseline and changes in sTNFR2 concentrations did not moderate anti-anhedonic efficacy. Infliximab significantly improved a measure of anhedonia relative to placebo in adults with bipolar I/II depression at week 6; intervention efficacy was not sustained 6 weeks after the final infusion.",2020,"Anti-anhedonic efficacy was moderated by baseline plasma levels of TNF-α and sTNFR1, but not by changes in TNF-α or sTNFR1 concentrations.","['n=31); 48 subjects completed the study ', 'Sixty eligible adults received treatment with', 'Adults (ages 18-65) with bipolar I/II disorder currently experiencing a major depressive episode with a higher probability of inflammatory activity (i.e., meeting one or more of the following inflammatory/metabolic criteria: obesity and dyslipidemia/hypertension, daily cigarette smoking, diabetes mellitus, migraine, inflammatory bowel disease, and/or C-reactive protein level of ⩾5 mg/L', 'Anhedonia in Bipolar I/II Depression']","['Adjunctive Infliximab vs. Placebo', 'adjunctive infliximab', 'tumour necrosis factor (TNF)-α antagonist infliximab', 'Infliximab', 'infliximab: n=21, placebo', 'infliximab', 'placebo']","['anhedonia relative', 'anhedonic symptoms', 'Plasma concentrations of TNF-α and soluble TNF receptors (sTNFR', 'SHAPS total score', 'Snaith-Hamilton Pleasure Scale (SHAPS) total score', 'sTNFR2 concentrations']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.341386,"Anti-anhedonic efficacy was moderated by baseline plasma levels of TNF-α and sTNFR1, but not by changes in TNF-α or sTNFR1 concentrations.","[{'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada; Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': ""Psychiatry; Centre for Neuroscience Studies, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Carmona', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychology, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Mehala', 'Initials': 'M', 'LastName': 'Subramaniapillai', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Zihang', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Shekotikhina', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Rosenblat', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA; VA Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada; Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Department of Pharmacology, University of Toronto, Toronto, ON, Canada; Brain and Cognition Discovery Foundation, Toronto, ON, Canada. Electronic address: Roger.McIntyre@uhn.ca.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.04.063']
163,32381562,Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction.,"BACKGROUND


The best strategy for maintaining clinical remission in patients with axial spondyloarthritis (axSpA) has not been defined. C-OPTIMISE compared dose continuation, reduction and withdrawal of the tumour necrosis factor inhibitor certolizumab pegol (CZP) following achievement of sustained remission in patients with early axSpA.
METHODS


C-OPTIMISE was a two-part, multicentre phase 3b study in adults with early active axSpA (radiographic or non-radiographic). During the 48-week open-label induction period, patients received CZP 200 mg every 2 weeks (Q2W). At Week 48, patients in sustained remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 at Weeks 32/36 and 48) were randomised to double-blind CZP 200 mg Q2W (full maintenance dose), CZP 200 mg every 4 weeks (Q4W; reduced maintenance dose) or placebo (withdrawal) for a further 48 weeks. The primary endpoint was remaining flare-free (flare: ASDAS ≥2.1 at two consecutive visits or ASDAS >3.5 at any time point) during the double-blind period.
RESULTS


At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo. During Weeks 48 to 96, 83.7% (87/104), 79.0% (83/105) and 20.2% (21/104) of patients receiving the full maintenance dose, reduced maintenance dose or placebo, respectively, were flare-free (p<0.001 vs placebo in both CZP groups). Responses in radiographic and non-radiographic axSpA patients were comparable.
CONCLUSIONS


Patients with early axSpA who achieve sustained remission at 48 weeks can reduce their CZP maintenance dose; however, treatment should not be completely discontinued due to the high risk of flare following CZP withdrawal.
TRIAL REGISTRATION NUMBER


NCT02505542, ClinicalTrials.gov.",2020,"At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo.","['ASDAS) <1.3 at Weeks 32/36 and 48', 'patients with early axSpA.\nMETHODS', 'patients with axial spondyloarthritis (axSpA', 'adults with early active axSpA (radiographic or non-radiographic']","['CZP 200\u2009mg every 2 weeks (Q2W', 'CZP 200\u2009mg every 4 weeks (Q4W; reduced maintenance dose) or placebo', 'CZP 200\u2009mg Q2W', 'placebo']","['remaining flare-free (flare: ASDAS', 'sustained remission (Ankylosing Spondylitis Disease Activity Score', 'sustained remission', 'flare-free']","[{'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]","[{'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}]",,0.666024,"At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo.","[{'ForeName': 'Robert Bm', 'Initials': 'RB', 'LastName': 'Landewé', 'Affiliation': 'Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, The Netherlands landewe@rlandewe.nl.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Depertment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Hopital Cochin, Rheumatology, Université Paris Descartes, Paris, France.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Ruhr University Bochum, Bochum, Herne, Germany.'}, {'ForeName': 'Filip E', 'Initials': 'FE', 'LastName': 'Van den Bosch', 'Affiliation': 'Department of Internal Medicine and Pediatrics, VIB Center for Inflammation Research, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Gaffney', 'Affiliation': 'Rheumatology Department, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bauer', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Hoepken', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Owen R', 'Initials': 'OR', 'LastName': 'Davies', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'de Peyrecave', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Gensler', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216839']
164,32381629,"Correction: First use of cenerimod, a selective S1P 1  receptor modulator, for the treatment of SLE: a double-blind, randomised, placebo-controlled, proof-of-concept study.",,2020,,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.29762,,[],Lupus science & medicine,['10.1136/lupus-2019-000354corr1']
165,32384457,Randomized cross-over trial of demand oxygen delivery system.,"INTRODUCTION


Long-term oxygen therapy is reported to improve hypoxemia and survival in patients with respiratory failure. The demand oxygen delivery system (DODS) saves oxygen and extends the usable time of an oxygen cylinder 2- to 3-fold. A portable oxygen concentrator with an auto-DODS has been developed to switch its sensitivity among 3 levels (standard, high, and extra high) and to supply pulsed-flow oxygen when it detects apnea. The aim of this study is to evaluate the efficacy of this newly developed portable oxygen concentrator with auto-DODS compared to the efficacy of conventional DODS in oxygenation.
METHODS AND ANALYSIS


Twenty-six patients with chronic obstructive pulmonary disease or interstitial pneumonia will be randomized to use auto-DODS or conventional DODS at rest and during a 6-minute walk test. Primary endpoints are mean oxygen saturation (SpO2) at rest and during the 6-minute walk test. Secondary endpoints are the ratios of the times during which the oxygen concentrator operates at each sensitivity mode (standard, high, and extra high) and at a constant pulse rate to the examination time, the ratio of the times during which SpO2 fall below 90% to the examination time, the lowest value of SpO2 during the examination time, the mean and highest pulse rates during the examination time, 6-minute walking distance, recovery time, Borg scale, comfort, and reliability, which are measured by a numerical rating scale and a questionnaire, respectively.
ETHICS AND DISSEMINATION


The study was conducted in accordance with the Declaration of Helsinki and was registered on Aug 23, 2019 (https://jrct.niph.go.jp/en-latest-detail/jRCTs052190041). The results of the study will be presented at academic conferences and submitted to a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


jRCTs052190041.",2020,The demand oxygen delivery system (DODS) saves oxygen and extends the usable time of an oxygen cylinder,"['Twenty-six patients with chronic obstructive pulmonary disease or interstitial pneumonia', 'accordance with the Declaration of Helsinki and was registered on Aug 23, 2019 (https://jrct.niph.go.jp/en-latest-detail/jRCTs052190041', 'patients with respiratory failure']","['conventional DODS', 'auto-DODS or conventional DODS']","['hypoxemia and survival', 'mean oxygen saturation (SpO2) at rest and during the 6-minute walk test', 'ratios of the times during which the oxygen concentrator operates at each sensitivity mode (standard, high, and extra high) and at a constant pulse rate to the examination time, the ratio of the times during which SpO2 fall below 90% to the examination time, the lowest value of SpO2 during the examination time, the mean and highest pulse rates during the examination time, 6-minute walking distance, recovery time, Borg scale, comfort, and reliability, which are measured by a numerical rating scale and a questionnaire, respectively']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0206061', 'cui_str': 'Interstitial pneumonia'}, {'cui': 'C0018898', 'cui_str': 'Declaration of Helsinki'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0182123', 'cui_str': 'Oxygen concentrator'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",26.0,0.0386822,The demand oxygen delivery system (DODS) saves oxygen and extends the usable time of an oxygen cylinder,"[{'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Nagano', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Clinical and Translational Research Center, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Otoshi', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Kanoko', 'Initials': 'K', 'LastName': 'Umezawa', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Katsurada', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Masatsugu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Tachihara', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}]",Medicine,['10.1097/MD.0000000000020010']
166,32384461,Efficacy of needle-knife combined with etanercept treatment regarding disease activity and hip joint function in ankylosing spondylitis patients with hip joint involvement: A randomized controlled study.,"This study aimed to assess the efficacy of needle-knife (NK) combined with etanercept (NKCE) in attenuating pain, inflammation, disease activity, and improving hip joint function in ankylosing spondylitis (AS) patients with hip joint involvement.Totally, 90 patients with active AS involving unilateral hip joint were enrolled and randomly assigned in 1:1:1 ratio to receive NKCE, NK or conventional drugs (control). The ESR, CRP, hip joint pain Visual Analogue Scale (VAS) score, bath ankylosing spondylitis disease activity index (BASDAI), bath ankylosing spondylitis functional index (BASFI), modified Harris hip score (mHHS), and range of motion (ROM) of affected hip joint were assessed at baseline (W0), after 1-week treatment (W1) and after 24-week treatment (W24).ESR and CRP were decreased in NKCE group compared with NK and control groups, while was not attenuated in NK group compared with control group. Regrading pain and disease activity, NKCE group presented a reduction in hip pain VAS score and BASDAI compared with NK and control groups, and NK group showed a decrease in hip pain VAS score and BASDAI compared with control group. Besides, BASFI was lowered in NKCE and NK groups compared with control group, but similar between NKCE and NK groups. mHHS and hip ROM were raised in NKCE and NK groups compared with control group, but similar between NKCE and NK groups.NKCE decreases hip pain, inflammation, disease activity and improves hip joint function in AS patients with hip joint involvement.",2020,"mHHS and hip ROM were raised in NKCE and NK groups compared with control group, but similar between NKCE and NK groups.","['90 patients with active AS involving unilateral hip joint', 'ankylosing spondylitis (AS) patients with hip joint involvement', 'AS patients with hip joint involvement', 'ankylosing spondylitis patients with hip joint involvement']","['needle-knife combined with etanercept', 'needle-knife (NK) combined with etanercept (NKCE', 'NKCE, NK or conventional drugs (control', 'NKCE']","['pain, inflammation, disease activity', 'BASFI', 'mHHS and hip ROM', 'Regrading pain and disease activity', 'disease activity and hip joint function', 'hip pain, inflammation, disease activity and improves hip joint function', 'hip pain VAS score and BASDAI', 'ESR, CRP, hip joint pain Visual Analogue Scale (VAS) score, bath ankylosing spondylitis disease activity index (BASDAI), bath ankylosing spondylitis functional index (BASFI), modified Harris hip score (mHHS), and range of motion (ROM) of affected hip joint']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}]","[{'cui': 'C0181464', 'cui_str': 'Needle knife'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C2363836', 'cui_str': 'Natural killer cell count'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]",90.0,0.0265861,"mHHS and hip ROM were raised in NKCE and NK groups compared with control group, but similar between NKCE and NK groups.","[{'ForeName': 'Yuquan', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'School of Biomedical Sciences, Huaqiao University.'}, {'ForeName': 'Meimei', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'School of Biomedical Sciences, Huaqiao University.'}, {'ForeName': 'Lianqun', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}, {'ForeName': 'Changxian', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Biomedical Sciences, Huaqiao University.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}]",Medicine,['10.1097/MD.0000000000020019']
167,32384462,Randomized cross-over trial of demand oxygen delivery system in nocturnal hypoxemia.,"BACKGROUND


It has not been determined that demand valve oxygen therapy is effective for nocturnal hypoxia. A portable oxygen concentrator with an auto-demand oxygen delivery system (auto-DODS; standard, high, and extra high) has recently been developed to improve oxygenation and comfort. This oxygen concentrator can supply a pulsed flow when it detects apnoea. The aim of this study is to demonstrate that this newly developed portable oxygen concentrator with an auto-demand function is non-inferior to a continuous-flow oxygen concentrator for nocturnal hypoxemia.
METHODS


Twenty patients with chronic obstructive pulmonary disease or interstitial pneumonia will be randomized to receive a portable oxygen concentrator with an auto-DODS or a continuous-flow oxygen concentrator during sleep. The primary endpoint is mean oxygen saturation (SpO2) during the total sleep time. The secondary endpoints are the ratios of time that the oxygen concentrator spends in each sensitivity mode (standard, high, and extra-high) and at a constant pulse rate to the total sleep time, the total time and ratio of time for which SpO2 is less than 90% during the total sleep time, the lowest value of SpO2 during the total sleep time, the mean and highest pulse rate during the total sleep time, the apnoea index during the total sleep time, the total sleep duration itself, and comfort and reliability as measured by numerical rating scale and questionnaires.
DISCUSSION


If the auto-DODS demonstrates non-inferiority to continuous flow in oxygenation during sleep, the auto-DODS can be used even at night, and the patient will need only 1 device.
TRIAL REGISTRATION


The study was registered on Aug 23, 2019 (jRCTs052190042).",2020,"If the auto-DODS demonstrates non-inferiority to continuous flow in oxygenation during sleep, the auto-DODS can be used even at night, and the patient will need only 1 device.
","['nocturnal hypoxemia', 'Twenty patients with chronic obstructive pulmonary disease or interstitial pneumonia']","['demand oxygen delivery system', 'portable oxygen concentrator with an auto-DODS or a continuous-flow oxygen concentrator during sleep']","['mean oxygen saturation (SpO2) during the total sleep time', 'total sleep time, the lowest value of SpO2 during the total sleep time, the mean and highest pulse rate during the total sleep time, the apnoea index during the total sleep time, the total sleep duration itself, and comfort and reliability as measured by numerical rating scale and questionnaires', 'ratios of time that the oxygen concentrator spends in each sensitivity mode (standard, high, and extra-high) and at a constant pulse rate to the total sleep time, the total time and ratio of time for which SpO2']","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0206061', 'cui_str': 'Interstitial pneumonia'}]","[{'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1618343', 'cui_str': 'Portable oxygen concentrator'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0182123', 'cui_str': 'Oxygen concentrator'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0182123', 'cui_str': 'Oxygen concentrator'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}]",20.0,0.0357811,"If the auto-DODS demonstrates non-inferiority to continuous flow in oxygenation during sleep, the auto-DODS can be used even at night, and the patient will need only 1 device.
","[{'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Nagano', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Clinical and Translational Research Center, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Otoshi', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Kanoko', 'Initials': 'K', 'LastName': 'Umezawa', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Katsurada', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Masatsugu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Tachihara', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}]",Medicine,['10.1097/MD.0000000000020031']
168,32384905,Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study.,"BACKGROUND


Plantar heel pain (PHP) is present in a wide range of individuals and creates significant burden to quality of life and participation in physical activity. The high recurrence rates and persistence of PHP suggests current management options may not address all potentially modifiable factors associated with the condition. Reports of intrinsic foot muscle (IFM) atrophy in individuals with PHP, together with biomechanical evidence of their important contribution to optimal foot function, suggests that an intervention focused on IFM training may be beneficial in managing PHP. We will test the feasibility of a prospective, assessor-blinded, parallel-group, randomised clinical trial that compares foot exercise plus education to brief advice in individuals with PHP.
METHODS


Twenty participants with PHP will be randomly allocated to one of two groups for a 12-week intervention period: (i) foot exercise plus education, or (ii) brief advice. The foot exercise plus education group will attend eight sessions with a physiotherapist and receive detailed education on self-management strategies as well as a progressive exercise program for the IFMs. The brief advice group will attend one session with a physiotherapist and receive brief information about self-management strategies and reassurance. Outcome measures will be obtained at baseline and the primary end-point of 12 weeks. Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention. Secondary outcomes will explore treatment effects, which will consist of pain, physical function, physical activity level, pain self-efficacy, perceived treatment effect, magnetic resonance and ultrasound image measurement of IFM morphology, ultrasound imaging measurement of plantar fascia thickness, IFM motor performance, foot posture, foot mobility, ankle dorsiflexion range of motion, toe flexor and plantar flexor strength/endurance.
DISCUSSION


To reduce the burden of PHP on individuals and society, there is a need to establish effective treatments that are feasible and accepted by patients and health professionals. This trial will be the first to evaluate the feasibility of conducting a full-scale RCT, as well as the credibility, acceptability, and treatment effects, of education and foot exercise for PHP. The findings of this study will inform the development of a full-scale RCT.
TRIAL REGISTRATION


The trial protocol was prospectively registered with the Australia and New Zealand Clinical Trial Registry (ACTRN12619000987167) on 11th July 2019.",2020,"Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention.","['individuals with PHP', 'Twenty participants with PHP']","['foot exercise plus education', 'Foot exercise plus education versus wait and see', 'IFM training', 'physiotherapist and receive detailed education on self-management strategies as well as a progressive exercise program for the IFMs', 'foot exercise plus education, or (ii) brief advice']","['treatment effects, which will consist of pain, physical function, physical activity level, pain self-efficacy, perceived treatment effect, magnetic resonance and ultrasound image measurement of IFM morphology, ultrasound imaging measurement of plantar fascia thickness, IFM motor performance, foot posture, foot mobility, ankle dorsiflexion range of motion, toe flexor and plantar flexor strength/endurance', 'feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231786', 'cui_str': 'Plantar heel pain'}]","[{'cui': 'C0454370', 'cui_str': 'Foot exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C1286219', 'cui_str': 'Mobility of foot'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0454370', 'cui_str': 'Foot exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",20.0,0.0820667,"Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention.","[{'ForeName': 'Melinda M', 'Initials': 'MM', 'LastName': 'Franettovich Smith', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia. melinda.smith@uq.edu.au.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Collins', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Mellor', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Grimaldi', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Elliott', 'Affiliation': 'Faculty of Medicine and Health and The Kolling Research Institute, The University of Sydney, Sydney, New South Wales, 2006, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hoggarth', 'Affiliation': 'Department of Physical Therapy and Human Movement Sciences, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Weber Ii', 'Affiliation': 'Systems Neuroscience and Pain Lab, Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}]",Journal of foot and ankle research,['10.1186/s13047-020-00384-1']
169,32385061,"Effect of PIFR-based optimised inhalation therapy in patients recovering from acute exacerbation of chronic obstructive pulmonary disease: protocol of a prospective, multicentre, superiority, randomised controlled trial.","INTRODUCTION


Acute exacerbation (AE) is a major cause of disease progression and death in patients with chronic obstructive pulmonary disease (COPD), accounting for majority of medical expenditures. Correct inhalation therapy is effective in preventing AE attacks. However, inappropriate usage of dry powder inhaler, partially due to the unrecovered peak inhalation flow rate (PIFR) after acute exacerbation of COPD (AECOPD), results in increased risk of early treatment failure. Therefore, we designed a multicentre, randomised clinical trial to determine whether PIFR-based optimised inhalation therapy and training on inhaler usage at discharge could effectively reduce early treatment failure events.
METHODS AND ANALYSIS


A total of 416 hospitalised patients just recovering from AECOPD will be recruited and equally randomised into the PIFR group and the control group at a 1:1 ratio. The PIFR group will receive additive support before discharge, including choice of PIFR-guided inhaler and education on its usage. PIFR is measured by InCheck DIAL. In comparison, the control group will receive inhalers based on judgement of the respiratory physician. The primary outcome of the study is 30-day treatment failure rate. Other endpoints include PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs.
ETHICS AND DISSEMINATION


The trial has been approved by the Ethics Committee of Zhongshan Hospital of Fudan University (B2019-142). Participants will be screened and enrolled from hospitalised patients with AECOPD by clinicians, with no public advertisement for recruitment. After the trial has completed, the results will be reported to the public through conference presentations and peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT04000958.",2020,"Other endpoints include PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs.
","['patients with chronic obstructive pulmonary disease (COPD', 'Participants will be screened and enrolled from hospitalised patients with AECOPD by clinicians, with no public advertisement for recruitment', '416 hospitalised patients just recovering from AECOPD', 'patients recovering from acute exacerbation of chronic obstructive pulmonary disease']","['PIFR-based optimised inhalation therapy and training', 'PIFR-based optimised inhalation therapy']","['30-day treatment failure rate', 'risk of early treatment failure', 'PIFR', 'peak inhalation flow rate (PIFR', 'PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021455', 'cui_str': 'Inhalation Devices'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}]",416.0,0.260112,"Other endpoints include PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs.
","[{'ForeName': 'Jianlan', 'Initials': 'J', 'LastName': 'Hua', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Fudan University, Shanghai, China.'}, {'ForeName': 'Hui-Fang', 'Initials': 'HF', 'LastName': 'Cao', 'Affiliation': ""Department of Pulmonary, Shanghai Jing'an District Central Hospital, Shanghai, China, Shanghai, China.""}, {'ForeName': 'Chun-Ling', 'Initials': 'CL', 'LastName': 'Du', 'Affiliation': 'Department of Pulmonary, Shanghai Qingpu District Central Hospital, Shanghai, China.'}, {'ForeName': 'Jia-Yun', 'Initials': 'JY', 'LastName': 'Ma', 'Affiliation': ""Department of Pulmonary, North Branch of Shanghai Ninth People's Hospital, Shanghai, China.""}, {'ForeName': 'Yi-Hui', 'Initials': 'YH', 'LastName': 'Zuo', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China jingatlas@hotmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-034804']
170,32385063,Cow's Milk Fat Obesity pRevention Trial (CoMFORT): a primary care embedded randomised controlled trial protocol to determine the effect of cow's milk fat on child adiposity.,"INTRODUCTION


Cow's milk is a dietary staple for children in North America. Though clinical guidelines suggest children transition from whole (3.25% fat) milk to reduced (1% or 2%) fat milk at age 2 years, recent epidemiological evidence supports a link between whole milk consumption and lower adiposity in children. The purpose of this trial is to determine which milk fat recommendation minimises excess adiposity and optimises child nutrition and growth.
METHODS AND ANALYSIS


Cow's Milk Fat Obesity pRevention Trial will be a pragmatic, superiority, parallel group randomised controlled trial involving children receiving routine healthcare aged 2 to 4-5 years who are participating in the TARGet Kids! practice-based research network in Toronto, Canada. Children (n=534) will be randomised to receive one of two interventions: (1) a recommendation to consume whole milk or (2) a recommendation to consume reduced (1%) fat milk. The primary outcome is adiposity measured by body mass index z-score and waist circumference z-score; secondary outcomes will be cognitive development (using the Ages and Stages Questionnaire), vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake (measured by 24 hours dietary recall) and cost effectiveness. Outcomes will be measured 24 months postrandomisation and compared using analysis of covariance (ANCOVA), adjusting for baseline measures.
ETHICS AND DISSEMINATION


Ethics approval has been obtained from Unity Health Toronto and The Hospital for Sick Children. Results will be presented locally, nationally and internationally and published in a peer-reviewed journal. The findings may be helpful to nutrition guidelines for children in effort to reduce childhood obesity using a simple, inexpensive and scalable cow's milk fat intervention.
TRIAL REGISTRATION NUMBER


NCT03914807; pre-results.",2020,"vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake (measured by 24 hours dietary recall) and cost effectiveness.","['Children (n=534', 'children in North America', 'children receiving routine healthcare aged 2 to 4-5 years who are participating in the TARGet Kids', 'child adiposity']","[""cow's milk fat"", 'recommendation to consume whole milk or (2) a recommendation to consume reduced (1%) fat milk']","['adiposity measured by body mass index z-score and waist circumference z-score; secondary outcomes will be cognitive development (using the Ages and Stages Questionnaire', 'vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C3256606', 'cui_str': 'milk fat, cow'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0452717', 'cui_str': 'Whole milk'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1535899', 'cui_str': 'Non-high-density lipoprotein cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",534.0,0.221937,"vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake (measured by 24 hours dietary recall) and cost effectiveness.","[{'ForeName': 'Shelley M', 'Initials': 'SM', 'LastName': 'Vanderhout', 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Aglipay', 'Affiliation': ""Pediatrics, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Birken', 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': ""O'Connor"", 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Thorpe', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Constantin', 'Affiliation': 'Department of Pediatrics, Mcgill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marie-Adele', 'Initials': 'MA', 'LastName': 'Davis', 'Affiliation': 'Canadian Paediatric Society, Ottawa, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Feldman', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Geoff D C', 'Initials': 'GDC', 'LastName': 'Ball', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Janus', 'Affiliation': 'Offord Centre for Child Studies, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Junker', 'Affiliation': 'Pediatrics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Laupacis', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""L'Abbé"", 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Manson', 'Affiliation': 'Health Promotion, Chronic Disease and Injury Prevention, Public Health Ontario, Ottawa, Ontario, Canada.'}, {'ForeName': 'Myla E', 'Initials': 'ME', 'LastName': 'Moretti', 'Affiliation': 'Clinical Trials Unit, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nav', 'Initials': 'N', 'LastName': 'Persaud', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Omand', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Relton', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Yamashiro', 'Affiliation': 'Ontario Medical Association, Toronto, Ontario, Canada.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Tavares', 'Affiliation': 'Patient Partner, Toronto, Ontario, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Weir', 'Affiliation': 'Patient Partner, Toronto, Ontario, Canada.'}, {'ForeName': 'Jonathon L', 'Initials': 'JL', 'LastName': 'Maguire', 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada jonathon.maguire@utoronto.ca.'}]",BMJ open,['10.1136/bmjopen-2019-035241']
171,32385918,Randomized Phase II Study of First-Line Biweekly Gemcitabine and Carboplatin Versus Biweekly Gemcitabine and Carboplatin plus Maintenance Gemcitabine in Elderly Patients with Untreated Non-Small Cell Lung Cancer: LOGIK0801.,"LESSONS LEARNED


The usefulness of maintenance gemcitabine (GEM) after biweekly carboplatin + GEM in elderly patients with non-small cell lung cancer could not be proved. Superior overall survival was obtained in the group that did not receive maintenance therapy.
BACKGROUND


The primary objective of this randomized phase II study was to assess progression-free survival (PFS) in elderly patients with advanced non-small cell lung cancer (NSCLC) treated with gemcitabine (GEM) maintenance therapy versus best supportive care following first-line GEM plus carboplatin (CBDCA).
METHODS


Elderly chemotherapy-naive patients with stage IIIB or IV NSCLC were randomly assigned 1:1 to the control arm or the study arm. All patients received biweekly combination therapy with GEM and CBDCA (1,000 mg/m 2  GEM and CBDCA at an area under the curve [AUC] of 3 on days 1 and 15, every 4 weeks). In the study arm, patients with objective response or stable disease following three or four cycles of initial chemotherapy received maintenance GEM.
RESULTS


Eighty-four patients were enrolled. The objective response rates (ORRs) were 17.5% in the control arm and 14.0% in the study arm. The most common toxicity was neutropenia (control arm: 47.5% and study arm: 69.8%). The median progression-free survivals were 4.99 months (control arm) and 4.44 months (study arm), and the median overall survivals (OSs) were 21.7 months (control arm) and 8.2 months (study arm).
CONCLUSION


Our data do not support maintenance GEM after biweekly CBDCA+GEM in elderly patients with NSCLC.",2020,The most common toxicity was neutropenia,"['elderly patients with non-small cell lung cancer', 'Elderly chemotherapy-naive patients with stage IIIB or IV NSCLC', 'elderly patients with advanced non-small cell lung cancer', 'Elderly Patients with Untreated Non-Small Cell Lung Cancer', 'elderly patients with NSCLC', 'Eighty-four patients were enrolled']","['Gemcitabine and Carboplatin Versus Biweekly Gemcitabine and Carboplatin plus Maintenance Gemcitabine', 'gemcitabine (GEM) maintenance therapy', 'GEM plus carboplatin (CBDCA', 'maintenance gemcitabine (GEM', 'biweekly combination therapy with GEM and CBDCA', 'carboplatin + GEM']","['neutropenia', 'Superior overall survival', 'median overall survivals (OSs', 'progression-free survival (PFS', 'objective response rates (ORRs', 'median progression-free survivals']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4319623', 'cui_str': '84'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",84.0,0.0509466,The most common toxicity was neutropenia,"[{'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Takayama', 'Affiliation': 'Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Takeshita', 'Affiliation': 'Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Ichiki', 'Affiliation': 'Department of Respirology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Fujita', 'Affiliation': 'Department of Respiratory Medicine, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Taishi', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Respiratory Medicine, Japan Community Healthcare Organization Kyushu Hospital, Kitakyushu, Japan.'}, {'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Shiraishi', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Wataya', 'Affiliation': 'Division of Internal Medicine, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Tokunaga', 'Affiliation': 'Medical Information Center, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Tadaaki', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Uchino', 'Affiliation': 'Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sugio', 'Affiliation': 'Department of Thoracic and Breast Surgery, Oita University, Faculty of Medicine, Oita, Japan.'}]",The oncologist,['10.1634/theoncologist.2020-0322']
172,32386747,Effect of immune regulatory pathways after immunization with GMZ2 malaria vaccine candidate in healthy lifelong malaria-exposed adults.,"BACKGROUND


Despite appreciable immunogenicity in malaria-naive populations, many candidate malaria vaccines are considerably less immunogenic in malaria-exposed populations. This could reflect induction of immune regulatory mechanisms involving Human Leukocyte Antigen G (HLA-G), regulatory T (Treg), and regulatory B (Breg) cells. Here, we addressed the question whether there is correlation between these immune regulatory pathways and both plasmablast frequencies and vaccine-specific IgG concentrations.
METHODS


Fifty Gabonese adults with lifelong exposure to Plasmodium spp were randomized to receive three doses of either 30 µg or 100 µg GMZ2-CAF01, or 100 µg GMZ2-alum, or control vaccine (rabies vaccine) at 4-week intervals. Only plasma and peripheral blood mononuclear cells isolated from blood samples collected before (D0) and 28 days after the third vaccination (D84) of 35 participants were used to measure sHLA-G levels and anti-GMZ2 IgG concentrations, and to quantify Treg, Breg and plasmablast cells. Vaccine efficacy was assessed using controlled human malaria infection (CHMI) by direct venous inoculation of Plasmodium falciparum sporozoites (PfSPZ Challenge).
RESULTS


The sHLA-G concentration increased from D0 to D84 in all GMZ2 vaccinated participants and in the control group, whereas Treg frequencies increased only in those receiving 30 µg or 100 µg GMZ2-CAF01. The sHLA-G level on D84 was associated with a decrease of the anti-GMZ2 IgG concentration, whereas Treg frequencies on D0 or on D84, and Breg frequency on D84 were associated with lower plasmablast frequencies. Importantly, having a D84:D0 ratio of sHLA-G above the median was associated with an increased risk of P. falciparum infection after sporozoites injection.
CONCLUSION


Regulatory immune responses are induced following immunization. Stronger sHLA-G and Treg immune responses may suppress vaccine induced immune responses, and the magnitude of the sHLA-G response increased the risk of Plasmodium falciparum infection after CHMI. These findings could have implications for the design and testing of malaria vaccine candidates in semi-immune individuals.",2020,"The sHLA-G level on D84 was associated with a decrease of the anti-GMZ2 IgG concentration, whereas Treg frequencies on D0 or on D84, and Breg frequency on D84 were associated with lower plasmablast frequencies.","['Fifty Gabonese adults with lifelong exposure to Plasmodium spp', 'healthy lifelong malaria-exposed adults']","['30\xa0µg or 100\xa0µg GMZ2-CAF01, or 100\xa0µg GMZ2-alum, or control vaccine (rabies vaccine', 'GMZ2 malaria vaccine candidate']","['Vaccine efficacy', 'sHLA-G levels and anti-GMZ2 IgG concentrations', 'anti-GMZ2 IgG concentration', 'Only plasma and peripheral blood mononuclear cells', 'sHLA-G concentration', 'risk of P. falciparum infection']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0051522', 'cui_str': 'aluminum sulfate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034496', 'cui_str': 'Rabies vaccine'}, {'cui': 'C0206255', 'cui_str': 'Malarial Vaccines'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",35.0,0.0706217,"The sHLA-G level on D84 was associated with a decrease of the anti-GMZ2 IgG concentration, whereas Treg frequencies on D0 or on D84, and Breg frequency on D84 were associated with lower plasmablast frequencies.","[{'ForeName': 'Odilon', 'Initials': 'O', 'LastName': 'Nouatin', 'Affiliation': ""Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany; Département de Biochimie et de Biologie Cellulaire, Faculté des Sciences et Techniques, Université d'Abomey-Calavi, Cotonou, Benin. Electronic address: paterneodilon@gmail.com.""}, {'ForeName': 'Ulysse', 'Initials': 'U', 'LastName': 'Ateba Ngoa', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon. Electronic address: ulyssus7000@gmail.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ibáñez', 'Affiliation': 'Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Dejon-Agobe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mordmüller', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: benjamin.mordmueller@uni-tuebingen.de.'}, {'ForeName': 'Jean Ronald', 'Initials': 'JR', 'LastName': 'Edoa', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany. Electronic address: j.ronaldedoa@cermel.org.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Mougeni', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Brückner', 'Affiliation': 'Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany. Electronic address: sinab@gmx.net.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Bouyoukou Hounkpatin', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Esen', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: meral.esen@uni-tuebingen.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Theisen', 'Affiliation': 'Department for Congenital Disorders, Statens Serum Institut, Copenhagen, Denmark and Centre for Medical Parasitology at Department of International Health, Immunology and Microbiology, University of Copenhagen, and Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Denmark. Electronic address: mth@ssi.dk.'}, {'ForeName': 'Kabirou', 'Initials': 'K', 'LastName': 'Moutairou', 'Affiliation': ""Département de Biochimie et de Biologie Cellulaire, Faculté des Sciences et Techniques, Université d'Abomey-Calavi, Cotonou, Benin. Electronic address: kamoutairo@yahoo.fr.""}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria Inc, Rockville, MD 20850, USA. Electronic address: slhoffman@sanaria.com.'}, {'ForeName': 'Saadou', 'Initials': 'S', 'LastName': 'Issifou', 'Affiliation': 'Fondation pour la Recherche Scientifique, 72 BP45 Cotonou, Benin. Electronic address: isaadou2002@yahoo.fr.'}, {'ForeName': 'Adrian J F', 'Initials': 'AJF', 'LastName': 'Luty', 'Affiliation': ""Centre d'Etude et de Recherche sur le Paludisme Associé à la Grossesse et à l'Enfance, Faculté des Sciences de la Santé, Université d'Abomey-Calavi, Cotonou, MERIT UMR D216, Benin; Université de Paris, MERIT, IRD, Paris, France. Electronic address: adrian.luty@ird.fr.""}, {'ForeName': 'Marguerite M', 'Initials': 'MM', 'LastName': 'Loembe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: mmassingaloembe@cermel.org.'}, {'ForeName': 'Selidji Todagbé', 'Initials': 'ST', 'LastName': 'Agnandji', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: agnandjis@cermel.org.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lell', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: bertrand.lell@cermel.org.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kremsner', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: peter.kremsner@uni-tuebingen.de.'}, {'ForeName': 'Ayôla Akim', 'Initials': 'AA', 'LastName': 'Adegnika', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany; Leiden University Medical Centre (LUMC), 2333 ZA Leiden, the Netherlands. Electronic address: aadegnika@cermel.org.'}]",Vaccine,['10.1016/j.vaccine.2020.04.046']
173,32393370,Comparing the effects of ketorolac and Paracetamol on postoperative pain relief after coronary artery bypass graft surgery. A randomized clinical trial.,"INTRODUCTION


Pain management after coronary artery bypass graft (CABG) surgery remains challenging.
OBJECTIVE


This study aimed to compare the effects of Ketorolac and Paracetamol on postoperative CABG pain relief.
METHOD


This double-blind randomized clinical trial study was conducted in Ahvaz, Iran, from September 2018-December 2019. Two consecutive groups of 60 patients undergoing elective on-pump coronary artery bypass graft surgery.
INTERVENTION


The patients were divided into 0.5 mg/kg of ketorolac mg/dl and 10 mg/kg of Paracetamol after surgery for pain management. Primary outcomes were: visual analog pain scale (VAS) at the time point immediately after extubation (baseline) and at 6, 12, 24 and 48 h and the total dose of morphine consumption. Secondary outcomes included the hemodynamic variables, weaning time, chest tube derange, in-hospital mortality and myocardial infarction.
STATISTICAL ANALYSIS


The data were analyzed using SPSS version 22(SPSS, Chicago, IL). The Mann-Whitney U-test was used to compare demographic data, VAS scores, vital signs, and side effects. Repeated measurements were tested within groups using Friedman's ANOVA and the Wilcoxon rank-sum test. Values were expressed as means ± standard deviations. Statistical significance was defined as a p-value < 0.05.
RESULTS


Compared with baseline scores, there were significant declines in VAS scores in both groups throughout the time sequence (P< 0.05). The statistical VAS score was slightly higher in the Paracetamol group at most time points, except for the time of 6 h. However, at 24 and 48 h, the VAS score in group Paracetamol was significantly higher than in group Ketorolac. There were no significant differences between groups about hemodynamic variables.
CONCLUSION


The efficacy of ketorolac is comparable to that of Paracetamol in postoperative CABG pain relief.
TRIAL REGISTRY


IRCT20150216021098N5. Registered at 2019-09-12.",2020,"The statistical VAS score was slightly higher in the Paracetamol group at most time points, except for the time of 6 h.","['60 patients undergoing elective on-pump coronary artery bypass graft surgery', 'Ahvaz, Iran, from September 2018-December 2019', 'after coronary artery bypass graft surgery']","['Ketorolac and Paracetamol', 'coronary artery bypass graft (CABG) surgery', 'ketorolac mg/dl and 10\u2009mg/kg of Paracetamol', 'Paracetamol', 'ketorolac', 'ketorolac and Paracetamol']","['VAS score', 'statistical VAS score', 'demographic data, VAS scores, vital signs, and side effects', 'postoperative CABG pain relief', 'hemodynamic variables, weaning time, chest tube derange, in-hospital mortality and myocardial infarction', 'visual analog pain scale (VAS', 'postoperative pain relief', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",60.0,0.1372,"The statistical VAS score was slightly higher in the Paracetamol group at most time points, except for the time of 6 h.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Javaherforooshzadeh', 'Affiliation': 'Department of Cardiac Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. f_javaherforoosh@yahoo.com.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Abdalbeygi', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Farahzad', 'Initials': 'F', 'LastName': 'Janatmakan', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Gholizadeh', 'Affiliation': 'Atherosclerosis Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01125-y']
174,32393387,The impact of glutamate infusion on postoperative NT-proBNP in patients undergoing coronary artery bypass surgery: a randomized study.,"BACKGROUND


Glutamate, a key intermediate in myocardial metabolism, may enhance myocardial recovery after ischemia and possibly reduce the incidence and severity of postoperative heart failure in coronary artery bypass surgery (CABG). N-terminal pro-B-type natriuretic peptide (NT-proBNP) can be used to assess postoperative heart failure (PHF) after CABG. Our hypothesis was that glutamate enhances myocardial recovery in post-ischemic heart failure and, therefore, will be accompanied by a mitigated postoperative increase of NT-proBNP.
METHODS


Substudy of the GLUTAmate for Metabolic Intervention in Coronary Surgery (GLUTAMICS) trial (ClinicalTrials.gov Identifier: NCT00489827) a prospective triple-center double-blind randomized clinical trial on 399 patients undergoing CABG with or without concomitant procedure for acute coronary syndrome at three Swedish Cardiac Surgery centres (Linköping, Örebro, and Karlskrona) from May 30, 2007 to November 12, 2009. Patients were randomly assigned to intravenous infusion of 0.125 M L-glutamic acid or saline (1.65 mL/kg of body weight per hour) intraoperatively and postoperatively. Plasma NT-proBNP was measured preoperatively, the first (POD1) and third postoperative morning (POD3). A Clinical Endpoints Committee, blinded to both intervention and NT-proBNP used prespecified criteria to diagnose PHF. The primary endpoints were the absolute levels of postoperative NT-proBNP and the difference between preoperative and postoperative levels of NT-proBNP.
RESULTS


Overall no significant difference was detected in postoperative NT-proBNP levels between groups. However, in high-risk patients (upper quartile of EuroSCORE II ≥ 4.15; glutamate group n = 56; control group n = 45) glutamate was associated with significantly lower postoperative increase of NT-proBNP (POD3-Pre: 3900 [2995-6260] vs. 6745 [3455-12,687] ng•L -1 , p = 0.012) and lower NT-proBNP POD3 (POD3: 4845 [3426-7423] vs. 8430 [5370-14,100] ng•L -1 , p = 0.001). After adjusting for significant differences in preoperative demographics, NT-proBNP POD3 in the glutamate group was 0.62 times of that in the control group (p = 0.002). Patients in the glutamate group also had shorter ICU stay (21 [19-26] vs. 25 [22-46] h, p = 0.025) and less signs of myocardial injury (Troponin T POD3 (300 [170-500] vs. 560 [210-910] ng•L -1 , p = 0.025).
CONCLUSIONS


Post hoc analysis of postoperative NT-proBNP suggests that intravenous infusion of glutamate may prevent or mitigate myocardial dysfunction in high-risk patients undergoing CABG. Further studies are necessary to confirm these findings. Trial registration Swedish Medical Products Agency 151:2003/70403 (prospectively registered with amendment about this substudy filed March 17, 2007). ClinicalTrials.gov Identifier: NCT00489827 (retrospectively registered) https://clinicaltrials.gov/ct2/show/NCT00489827?term=glutamics&draw=1&rank=1.",2020,"After adjusting for significant differences in preoperative demographics, NT-proBNP POD3 in the glutamate group was 0.62 times of that in the control group (p = 0.002).","['coronary artery bypass surgery (CABG', 'for acute coronary syndrome at three Swedish Cardiac Surgery centres (Linköping, Örebro, and Karlskrona) from May 30, 2007 to November 12, 2009', 'patients undergoing coronary artery bypass surgery', 'high-risk patients undergoing CABG', '399 patients undergoing']","['CABG with or without concomitant procedure', 'glutamate infusion', 'intravenous infusion of 0.125\xa0M\xa0L-glutamic acid or saline', 'N-terminal pro-B-type natriuretic peptide (NT-proBNP']","['signs of myocardial injury (Troponin T POD3', 'postoperative NT-proBNP', 'myocardial dysfunction', 'preoperative demographics, NT-proBNP POD3', 'postoperative NT-proBNP levels', 'Plasma NT-proBNP', 'shorter ICU stay', 'lower NT-proBNP POD3', 'postoperative increase of NT-proBNP', 'absolute levels of postoperative NT-proBNP and the difference between preoperative and postoperative levels of NT-proBNP']","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C4517427', 'cui_str': '0.125'}, {'cui': 'C0061472', 'cui_str': 'Glutamic acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0340515', 'cui_str': 'Myocardial dysfunction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",399.0,0.384104,"After adjusting for significant differences in preoperative demographics, NT-proBNP POD3 in the glutamate group was 0.62 times of that in the control group (p = 0.002).","[{'ForeName': 'Huiqi', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine and Health Sciences, Unit of Cardiovascular Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Holm', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine and Health Sciences, Unit of Cardiovascular Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Vidlund', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Farkas', 'Initials': 'F', 'LastName': 'Vanky', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine and Health Sciences, Unit of Cardiovascular Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Örjan', 'Initials': 'Ö', 'LastName': 'Friberg', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Yanqi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine and Health Sciences, Unit of Cardiovascular Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Svedjeholm', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine and Health Sciences, Unit of Cardiovascular Sciences, Linköping University, Linköping, Sweden. rolf.svedjeholm@regionostergotland.se.'}]",Journal of translational medicine,['10.1186/s12967-020-02351-7']
175,31830776,Effects of probiotics or broccoli supplementation on Helicobacter pylori eradication with standard clarithromycin-based triple therapy.,"BACKGROUND/AIMS


The eradication failure rate of standard triple therapy (proton pump inhibitor, clarithromycin, and amoxicillin) for Helicobacter pylori infection has increased owing to antibiotic resistance in Korea. We assessed whether Saccharomyces boulardii probiotic or broccoli sprout extract sulforaphane supplementation could increase the H. pylori eradication rate and/or reduce antibiotic-associated adverse events.
METHODS


A total of 217 patients with H. pylori-positive chronic gastritis or peptic ulcer disease were recruited. Clarithromycin resistance was assessed in all patients by testing for A2142G and A2143G point mutations in H. pylori 23S rRNA using a dual-priming polymerase chain reaction (PCR) oligonucleotide. Thirty-four patients (17.3%) were clarithromycin-resistant and were excluded from the study. Finally, 183 patients with infections not resistant to clarithromycin were randomly assigned to triple therapy only (group A, n = 61), triple therapy plus probiotics (group B, n = 61), or triple therapy plus sulforaphane (group C, n = 61) groups. CYP2C19 polymorphisms were examined at position G681A of exon 5 and G636A of exon 4 by PCR with restriction fragment length polymorphism (PCR-RFLP) analysis. H. pylori eradication was assessed by 13C-urea breath test 4 weeks after treatment completion.
RESULTS


The eradication rates were similar among the groups both in the intention- to-treat (A = 85.2%, B = 89.6%, and C = 81.6%) and per-protocol (A = 89.2%, B = 86.8%, and C = 96.3%) analyses. The frequencies of overall adverse events in the groups also did not differ (A vs. B: p = 0.574; A vs. C: p = 1.000).
CONCLUSION


Probiotic or sulforaphane with triple therapy for H. pylori infection neither increased the eradication rate nor reduced the occurrence of adverse events.",2020,"The eradication rates were similar among the groups both in the intention- to-treat (A = 85.2%, B = 89.6%, and C = 81.6%) and per-protocol (A = 89.2%, B = 86.8%, and C = 96.3%) analyses.","['217 patients with H. pylori-positive chronic gastritis or peptic ulcer disease were recruited', 'Thirty-four patients (17.3%) were clarithromycin-resistant and were excluded from the study', '183 patients with infections not resistant to']","['triple therapy plus probiotics', 'dual-priming polymerase chain reaction (PCR) oligonucleotide', 'Saccharomyces boulardii probiotic or broccoli sprout extract sulforaphane supplementation', 'triple therapy plus sulforaphane', 'Probiotic or sulforaphane', 'standard clarithromycin-based triple therapy', 'probiotics or broccoli supplementation', 'standard triple therapy (proton pump inhibitor, clarithromycin, and amoxicillin', 'clarithromycin']","['frequencies of overall adverse events', 'H. pylori infection', 'eradication failure rate', 'Clarithromycin resistance', 'occurrence of adverse events', 'eradication rate', 'Helicobacter pylori eradication', 'H. pylori eradication rate and/or reduce antibiotic-associated adverse events', 'eradication rates', 'H. pylori eradication']","[{'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085695', 'cui_str': 'Chronic gastritis'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0028953', 'cui_str': 'Oligonucleotide'}, {'cui': 'C0772093', 'cui_str': 'Saccharomyces boulardii'}, {'cui': 'C1707048', 'cui_str': 'broccoli sprout extract'}, {'cui': 'C0163159', 'cui_str': 'sulforafan'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0330498', 'cui_str': 'Brassica oleracea'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",217.0,0.107694,"The eradication rates were similar among the groups both in the intention- to-treat (A = 85.2%, B = 89.6%, and C = 81.6%) and per-protocol (A = 89.2%, B = 86.8%, and C = 96.3%) analyses.","[{'ForeName': 'Young Woon', 'Initials': 'YW', 'LastName': 'Chang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yoo Min', 'Initials': 'YM', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chi Hyuk', 'Initials': 'CH', 'LastName': 'Oh', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Shin Ju', 'Initials': 'SJ', 'LastName': 'Oh', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jun-Hyung', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jung-Wook', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.'}]",The Korean journal of internal medicine,['10.3904/kjim.2019.139']
176,32394777,"Randomized Trial of Combined Aerobic, Resistance, and Cognitive Training to Improve Recovery From Stroke: Feasibility and Safety.","Background Physical exercise and cognitive training have been recommended to improve cognitive outcomes poststroke, but a multifaceted strategy including aerobic, resistance, and cognitive training to facilitate poststroke recovery has not been investigated. We aimed to assess the feasibility, adherence, and safety of a combined aerobic, resistance, and cognitive training intervention (CARET+CTI) after stroke. Methods and Results We prospectively randomized patients presenting with recent stroke to a comparison of a supervised 12-week CARET+CTI program and a control group receiving sham CARET+CTI. Participants were scheduled for 3 weekly CARET and CTI sessions. All participants underwent pre- and postintervention assessments of strength, endurance, and cognition. The primary outcomes were feasibility and adherence, defined as the ratio of scheduled and observed visits, and safety. We enrolled 131 participants, of whom 37 withdrew from the study. There were 17 (20%) withdrawals in the CARET+CTI and 20 (44%) in the control group. The observed-over-expected visit ratio was significantly higher in the intervention than in the control group (0.74±0.30 versus 0.54±0.38;  P =0.003). A total of 99 adverse events were reported by 59 participants, none of which were serious and related to the intervention. Greater gains in physical, cognitive, and mood outcomes were found in the CARET+CTI group than in the control group, but were not statistically significant after adjustments. Conclusions A CARET+CTI intervention, after stroke, is safe, feasible, and has satisfactory participant adherence over 12 weeks. REGISTRATION URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT02272426.",2020,The observed-over-expected visit ratio was significantly higher in the intervention than in the control group (,"['Stroke', 'We enrolled 131 participants, of whom 37 withdrew from the study', 'patients presenting with recent stroke to a comparison of a']","['Combined Aerobic, Resistance, and Cognitive Training', 'combined aerobic, resistance, and cognitive training intervention (CARET+CTI', 'supervised 12-week CARET+CTI program and a control group receiving sham CARET+CTI', ' Physical exercise and cognitive training']","['Greater gains in physical, cognitive, and mood outcomes', 'feasibility, adherence, and safety', 'feasibility and adherence, defined as the ratio of scheduled and observed visits, and safety', 'strength, endurance, and cognition', 'Feasibility and Safety', 'observed-over-expected visit ratio']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",131.0,0.0361699,The observed-over-expected visit ratio was significantly higher in the intervention than in the control group (,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Koch', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Tiozzo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Marialaura', 'Initials': 'M', 'LastName': 'Simonetto', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Clinton B', 'Initials': 'CB', 'LastName': 'Wright', 'Affiliation': 'National Institute of Neurological Disorders and Stroke (NINDS) Bethesda MD.'}, {'ForeName': 'Chuanhui', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bustillo', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Perez-Pinzon', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Kunjan R', 'Initials': 'KR', 'LastName': 'Dave', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Carolina M', 'Initials': 'CM', 'LastName': 'Gutierrez', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lewis', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Marti', 'Initials': 'M', 'LastName': 'Flothmann', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'M Carolina', 'Initials': 'MC', 'LastName': 'Mendoza-Puccini', 'Affiliation': 'National Institute of Neurological Disorders and Stroke (NINDS) Bethesda MD.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Junco', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Zuzel', 'Initials': 'Z', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Gomes-Osman', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Rundek', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Ralph L', 'Initials': 'RL', 'LastName': 'Sacco', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015377']
177,32396095,Home-Based Functional Electrical Stimulation-Assisted Hand Therapy Video Games for Children with Hemiplegia: Development and Proof-of-Concept.,"We describe the development and three case reports of a home-based intervention for children with hand hemiplegia that integrates custom video games with contralaterally controlled functional electrical stimulation (CCFES). With CCFES, stimulated opening of the more-affected hand is modulated by volitional opening of the less-affected hand. Video games that solicit goal-oriented, skill-requiring movement have shown promise for treating hemiplegia, but they have not previously been combined with electrical stimulation in children. Three children ages 8, 9, and 11 with moderate-to-severe hand hemiplegia were assigned six weeks of therapy in lab and at home. The goal was to determine if children could tolerate 9 lab treatment sessions and administer up to 7.5 hrs/wk of CCFES video game therapy at home. The feasibility of this intervention for home use was assessed by device logs, end-of-treatment interviews, and motor function/impairment assessments. With caregiver help, the children were all able to attend 9 lab sessions and built up to 7.5 hrs/wk of therapy by week 3. They averaged 5-7 hrs/wk of home intervention overall. Motor outcomes improved for all three participants at treatment end, but mostly regressed at 4-weeks follow-up. Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2. We found preliminary indications that CCFES-integrated video game therapy can provide a high dose of hand motor control therapy at home and in the lab. Improvements in motor outcomes were also observed, but more development and study is needed.",2020,"Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2.","['Children with Hemiplegia', 'Three children ages 8, 9, and 11 with moderate-to-severe hand hemiplegia', 'children with hand hemiplegia that integrates']","['custom video games with contralaterally controlled functional electrical stimulation (CCFES', 'CCFES-integrated video game therapy', 'home-based intervention', 'CCFES video game therapy', 'Home-Based Functional Electrical Stimulation-Assisted Hand Therapy Video Games']",['Motor outcomes'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}]",3.0,0.063265,"Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Curby', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Suder', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Katholi', 'Affiliation': ''}, {'ForeName': 'Jayme S', 'Initials': 'JS', 'LastName': 'Knutson', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2020.2992036']
178,32392019,Financial Toxicity After Acute Respiratory Distress Syndrome: A National Qualitative Cohort Study.,"OBJECTIVES


The financial burdens and subsequent related distress of medical care, referred to as financial toxicity, may limit access to beneficial treatments. However, financial toxicity after acute care is less described-and may be an important but underexplored mechanism preventing full recovery after critical illnesses such as acute respiratory distress syndrome. We sought to identify the mechanisms by which financial toxicity manifested in patients with acute respiratory distress syndrome, protective factors against such toxicity, and the consequences of financial toxicity to survivors' lives following acute respiratory distress syndrome.
DESIGN


We conducted semistructured interviews following patients' hospitalization and during recovery as an ancillary study to a multicenter randomized clinical trial in acute respiratory distress syndrome. Patients were 9-16 months post randomization at the time of interview.
SETTING AND PARTICIPANTS


The Reevaluation Of Systemic Early Neuromuscular Blockade trial examined the use of early neuromuscular blockade in mechanically ventilated patients with moderate/severe acute respiratory distress syndrome. We recruited consecutive surviving patients who were English speaking, consented to follow-up, and were randomized between December 11, 2017, and May 4, 2018 (n = 79) from 29 U.S. sites.
MEASUREMENTS AND MAIN RESULTS


We asked about patients' perceptions of financial burden(s) that they associated with their acute respiratory distress syndrome hospitalization. Forty-six of 79 eligible acute respiratory distress syndrome survivors (58%) participated (from 22 sites); their median age was 56 (interquartile range 47-62). Thirty-one of 46 reported at least one acute respiratory distress syndrome-related financial impact. Financial toxicity manifested via medical bills, changes in insurance coverage, and loss of employment income. Respondents reported not working prior to acute respiratory distress syndrome, using Medicaid or Medicare, or, conversely, generous work benefits as factors which may have limited financial burdens. Patients reported multiple consequences of acute respiratory distress syndrome-related financial toxicity, including harms to their mental and physical health, increased reliance on others, and specific material hardships.
CONCLUSIONS


Financial toxicity related to critical illness is common and may limit patients' emotional, physical, and social recovery after acute respiratory distress syndrome hospitalization for at least a year.",2020,"Patients reported multiple consequences of acute respiratory distress syndrome-related financial toxicity, including harms to their mental and physical health, increased reliance on others, and specific material hardships.
","['patients with acute respiratory distress syndrome', 'acute respiratory distress syndrome', 'consecutive surviving patients who were English speaking, consented to follow-up, and were randomized between December 11, 2017, and May 4, 2018 (n = 79) from 29 U.S. sites', 'Forty-six of 79 eligible acute respiratory distress syndrome survivors (58%) participated (from 22 sites); their median age was 56 (interquartile range 47-62', 'mechanically ventilated patients with moderate/severe acute respiratory distress syndrome', 'Thirty-one of 46 reported at least one acute respiratory distress syndrome-related financial impact', 'After Acute Respiratory Distress Syndrome']",[],"['Financial toxicity manifested via medical bills, changes in insurance coverage, and loss of employment income', 'acute respiratory distress syndrome hospitalization', 'financial toxicity', 'Financial Toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",[],"[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0004895', 'cui_str': 'Beak'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0425083', 'cui_str': 'Loss of job'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.13736,"Patients reported multiple consequences of acute respiratory distress syndrome-related financial toxicity, including harms to their mental and physical health, increased reliance on others, and specific material hardships.
","[{'ForeName': 'Katrina E', 'Initials': 'KE', 'LastName': 'Hauschildt', 'Affiliation': 'Department of Sociology, College of Literature, Science, and Arts, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Seigworth', 'Affiliation': 'Veterans Affairs Center for Clinical Management Research, HSR&D Center of Innovation, Ann Arbor, MI.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Kamphuis', 'Affiliation': 'Veterans Affairs Center for Clinical Management Research, HSR&D Center of Innovation, Ann Arbor, MI.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': 'Department of Medicine, Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'McPeake', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow Royal Infirmary, Glasgow, United Kingdom.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Iwashyna', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, MI.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004378']
179,32387472,Folinic acid improves the score of Autism in the EFFET placebo-controlled randomized trial.,"Autism spectrum disorders (ASD) are influenced by interacting maternal and environmental risk factors. High-dose folinic acid has shown improvement in verbal communication in ASD children. The EFFET randomized placebo-controlled trial (NCT02551380) aimed to evaluate the efficacy of folinic acid (FOLINORAL®) at a lower dose of 5 mg twice daily. Nineteen children were included in the EFFET trial. The primary efficacy outcome was improvement of Autism Diagnostic Observation Schedule (ADOS) score. The secondary outcomes were the improvement in ADOS sub scores communication, social interactions, Social Responsiveness Score (SRS) and treatment safety. The global ADOS score and social interaction and communication sub scores were significantly improved at week 12 compared to baseline in the folinic acid group (P = 0.003, P = 0.004 and P = 0.022, respectively), but not in the placebo group (P = 0.574, P = 0.780, P = 0.269, respectively). We observed a greater change of ADOS global score (-2.78 vs. -0.4 points) and (-1.78 vs. 0.20 points) in the folinic acid group, compared to the placebo group. No serious adverse events were observed. This pilot study showed significant efficacy of folinic acid with an oral formulation that is readily available. It opens a perspective of therapeutic intervention with folinic acid but needs to be confirmed by a multi-center trial on a larger number of children.",2020,"The global ADOS score and social interaction and communication sub scores were significantly improved at week 12 compared to baseline in the folinic acid group (P = 0.003, P = 0.004 and P = 0.022, respectively), but not in the placebo group (P = 0.574, P = 0.780, P = 0.269, respectively).","['Nineteen children were included in the EFFET trial', 'Autism spectrum disorders (ASD', 'ASD children']","['High-dose folinic acid', 'placebo', 'folinic acid (FOLINORAL®', 'Folinic acid', 'folinic acid']","['verbal communication', 'Autism Diagnostic Observation Schedule (ADOS) score', 'improvement in ADOS sub scores communication, social interactions, Social Responsiveness Score (SRS) and treatment safety', 'ADOS global score', 'serious adverse events', 'global ADOS score and social interaction and communication sub scores']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",19.0,0.384112,"The global ADOS score and social interaction and communication sub scores were significantly improved at week 12 compared to baseline in the folinic acid group (P = 0.003, P = 0.004 and P = 0.022, respectively), but not in the placebo group (P = 0.574, P = 0.780, P = 0.269, respectively).","[{'ForeName': 'Emeline', 'Initials': 'E', 'LastName': 'Renard', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Leheup', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France.'}, {'ForeName': 'Rosa-Maria', 'Initials': 'RM', 'LastName': 'Guéant-Rodriguez', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France.'}, {'ForeName': 'Abderrahim', 'Initials': 'A', 'LastName': 'Oussalah', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Quadros', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France; Department of Medicine, SUNY Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Guéant', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France. Electronic address: jean-louis.gueant@univ-lorraine.fr.'}]",Biochimie,['10.1016/j.biochi.2020.04.019']
180,32289353,Risk of contamination when planning psychological therapy trials can be assessed using a simple framework.,"OBJECTIVES


The objective of this study was to develop and pilot a standard framework that could be used to assess risk of contamination in psychological therapy trials, at the protocol development stage.
STUDY DESIGN AND SETTING


We developed and piloted a risk of contamination framework on a sample of 100 psychological therapy trial protocols registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry (www.isrctn.com). We assessed all protocols as being low or high risk via three possible sources of contamination: 1) participants in the control arm, 2) participants in the intervention arm, 3) therapists in the intervention arm.
RESULTS


Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%). We identified 14 studies that had a potentially high risk for contamination. Most of these (N = 10) were identified as risk of contamination arising from a therapist in the intervention arm.
CONCLUSION


The risk of contamination framework we piloted in this study could be a helpful tool for researchers aiming to identify and manage risk of contamination in their trial protocol development. We found that the risk of contamination was relatively low in the psychological therapy trials we sampled for this study, as measured by our framework, and could usually be mitigated through reasonable adjustments to the study design.",2020,"Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%).","['contamination: 1) participants in the control arm, 2) participants in the intervention arm, 3) therapists in the intervention arm']",[],['risk of contamination'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}]",10.0,0.109149,"Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%).","[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Jacobsen', 'Affiliation': ""Department of Psychology, University of Bath, Bath BA2 7AY; King's College London, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London SE5 8AF. Electronic address: p.c.jacobsen@bath.ac.uk.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wood', 'Affiliation': 'Acute and Rehabilitation Directorate Psychology Team, North East London NHS Foundation Trust, Goodmayes Hospital, Barley Lane, Ilford IG3 8XJ; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road W1T 7DN.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.04.005']
181,32388179,Do menopausal status and APOE4 genotype alter the long-term effects of intensive lifestyle intervention on cognitive function in women with type 2 diabetes mellitus?,"In the Look AHEAD trial, randomization to Intensive Lifestyle Intervention (ILI) or Diabetes Support and Education (DSE) did not result in differences in cognitive outcomes. However, menopause and APOE genotype are factors that affect the response to this intervention. The effect of this intervention on a single cognitive assessment was examined in 3 groups of women: premenopausal or <5 years postmenopausal (N = 594), within 5-10 years (n = 388), and ≥10 years postmenopausal (n = 963), and as a function of continuous years since menopause. The late postmenopausal group in the ILI had worse composite z-scores compared to those in the DSE, whereas the younger premenopausal or early postmenopausal women in the ILI had better composite z-scores than the DSE. A significant interaction between years since menopause and intervention arm, but not baseline age, was observed on executive function domains. ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause. These findings emphasize the importance of assessing menopause and APOE status to understand how weight loss impacts cognition.",2020,ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause.,"['women with type 2 diabetes mellitus', '3 groups of women: premenopausal or <5\xa0years postmenopausal (N\xa0= 594), within 5-10\xa0years (n\xa0= 388), and ≥10\xa0years postmenopausal (n\xa0= 963), and as a function of continuous years since menopause']","['Intensive Lifestyle Intervention (ILI) or Diabetes Support and Education (DSE', 'intensive lifestyle intervention']","['cognitive function', 'composite z-scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",,0.020602,ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause.,"[{'ForeName': 'Hussein N', 'Initials': 'HN', 'LastName': 'Yassine', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. Electronic address: hyassine@usc.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Brinton', 'Affiliation': 'Departments of Pharmacology and Neurology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Carmichael', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Hoscheidt', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Hugenschmidt', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Keller', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}]",Neurobiology of aging,['10.1016/j.neurobiolaging.2020.03.020']
182,32388198,Cost-Effectiveness Analysis of Xpert MTB/RIF for Multi-Outcomes of Presumptive Pulmonary Tuberculosis Patients in Thailand.,"OBJECTIVES


The cost-effectiveness of screening adult patients for pulmonary tuberculosis is not clear. As such, this study aims to identify the cost-effectiveness between the Xpert MTB/RIF assay and the sputum acid-fast bacilli (AFB) smear. Multi-outcomes were correct diagnosis, time to achieve correct diagnosis, and gain in quality-adjusted life-years (QALYs).
METHODS


A decision tree model was constructed to reveal a possible clinical pathway of tuberculosis diagnosis. The researchers used a clinical study to establish the probability of all clinical pathways for input into this model. The sample size was calculated following the correct diagnosis. Participants were randomly divided into 2 groups. A structural questionnaire and the Thai version of quality of life (EQ-5D-5L) were used for interviewing.
RESULTS


The results showed that the time to achieve the correct diagnosis for the group using Xpert MTB/RIF was shorter than that for the group using the sputum AFB smear. Both the correct diagnosis and QALYs of the base case analysis presented the Xpert MTB/RIF method as dominant. A Monte Carlo model, which analyzed the Xpert MTB/RIF method, revealed that the average number of patients who were correctly diagnosed was 673, the QALYs were 945.85 years, and the total cost was $143 110.64. For the sputum AFB smear method, the average number who received a correct diagnosis was 592, the QALYs were 940.40 years, and the total cost was $196 666.84. Probabilistic and one-way sensitivity analysis confirmed that the Xpert MTB/RIF remained dominant.
CONCLUSIONS


These results provide useful information for the National Strategic Plan to screen all adult patients for pulmonary tuberculosis.",2020,The results showed that the time to achieve the correct diagnosis for the group using Xpert MTB/RIF was shorter than that for the group using the sputum AFB smear.,"['Presumptive Pulmonary Tuberculosis Patients in Thailand', 'adult patients for pulmonary tuberculosis']","['Xpert MTB/RIF assay and the sputum acid-fast bacilli (AFB) smear', 'Xpert MTB/RIF']","['total cost', 'correct diagnosis', 'quality of life (EQ-5D-5L', 'cost-effectiveness', 'correct diagnosis, time to achieve correct diagnosis, and gain in quality-adjusted life-years (QALYs']","[{'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1318720', 'cui_str': 'Acid fast stain'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0222549,The results showed that the time to achieve the correct diagnosis for the group using Xpert MTB/RIF was shorter than that for the group using the sputum AFB smear.,"[{'ForeName': 'Jiraporn', 'Initials': 'J', 'LastName': 'Khumsri', 'Affiliation': 'Department of Medical Services, Nopparat Rajathanee Hospital, Ministry of Public Health, Bangkok, Thailand; Department of Preventive and Social Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Piya', 'Initials': 'P', 'LastName': 'Hanvoravongchai', 'Affiliation': 'Department of Medical Services, Nopparat Rajathanee Hospital, Ministry of Public Health, Bangkok, Thailand; Thailand Research Center for Health Services System, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Narin', 'Initials': 'N', 'LastName': 'Hiransuthikul', 'Affiliation': 'Department of Medical Services, Nopparat Rajathanee Hospital, Ministry of Public Health, Bangkok, Thailand. Electronic address: nhiransu@yahoo.com.'}, {'ForeName': 'Charoen', 'Initials': 'C', 'LastName': 'Chuchottaworn', 'Affiliation': 'Department of Medical Services, Central Chest Institute of Thailand, Ministry of Public Health, Nonthaburi, Thailand.'}]",Value in health regional issues,['10.1016/j.vhri.2019.09.010']
183,32388274,Effects of seafood consumption on mercury exposure in Norwegian pregnant women: A randomized controlled trial.,"BACKGROUND


Seafood provides nutrients that are important for optimal development of the unborn child. However, seafood is also a source of contaminants including mercury (Hg) and methylmercury (MeHg) that may have adverse effects on neurodevelopment of the fetus. Humans are predominantly exposed to MeHg through seafood consumption, however, levels of MeHg vary considerably between species.
OBJECTIVES


Investigate, in a randomized controlled trial (RCT) during pregnancy, if an increased intake of Atlantic cod (Gadus morhua), a fish species with relatively low levels of MeHg contamination, influences total hair Hg (THHg) concentrations in humans.
METHODS


Pregnant women (n = 137) were enrolled in the RCT ""Mommy's Food"" (2016-2017), which was designed to increase iodine status. Participants were randomly assigned to intervention (400 g of cod fillets per week) or control (continued habitual diet) groups for 16 weeks (gestational week 20-36). THHg concentrations were measured at baseline and post-intervention using thermal decomposition, amalgamation, and atomic absorption spectrophotometry (US EPA method 7473). The trial is registered in ClinicalTrials.gov, NCT02610959.
RESULTS


Post-intervention, the intervention group had median (inter-quartile range) THHg concentrations of 554 (392-805) µg/kg, and the control group 485 (341-740) µg/kg (p = 0.186). When adjusting for baseline THHg concentrations, there was a significant difference between the groups in those participants with baseline THHg concentrations below 534 µg/kg. Post-intervention, 8% of the study population exceeded the US EPA reference dose in hair (1,000 µg/kg) (intervention group: n = 6, control group: n = 4).
CONCLUSION


THHg concentrations were generally low in both study groups of pregnant women, despite the relatively high seafood intake. While the intervention with 400 g of cod per week slightly increased THHg concentrations, it did not lead to an increase in number of subjects exceeding the US EPA reference dose; a dose level at which no adverse effects are expected to occur over a period of lifetime exposure.",2020,"While the intervention with 400 g of cod per week slightly increased THHg concentrations, it did not lead to an increase in number of subjects exceeding the US EPA reference dose; a dose level at which no adverse effects are expected to occur over a period of lifetime exposure.","['Pregnant women (n\u202f=\u202f137', 'Norwegian pregnant women', 'humans']","['RCT', 'seafood consumption', 'intervention (400\xa0g of cod fillets per week) or control (continued habitual diet']","['total hair Hg (THHg) concentrations', 'iodine status', 'THHg concentrations']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0206208', 'cui_str': 'Seafood'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0184934', 'cui_str': 'Filleting'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",7473.0,0.204374,"While the intervention with 400 g of cod per week slightly increased THHg concentrations, it did not lead to an increase in number of subjects exceeding the US EPA reference dose; a dose level at which no adverse effects are expected to occur over a period of lifetime exposure.","[{'ForeName': 'Synnøve', 'Initials': 'S', 'LastName': 'Næss', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway. Electronic address: synnoeve.naess@hi.no.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Kjellevold', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Dahl', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Ive', 'Initials': 'I', 'LastName': 'Nerhus', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Lisa Kolden', 'Initials': 'LK', 'LastName': 'Midtbø', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Bank', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway; University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Josef D', 'Initials': 'JD', 'LastName': 'Rasinger', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Maria Wik', 'Initials': 'MW', 'LastName': 'Markhus', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}]",Environment international,['10.1016/j.envint.2020.105759']
184,32389105,Study protocol and statistical analysis plan for the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial.,"BACKGROUND


Contemporary glucose management of intensive care unit (ICU) patients with type 2 diabetes is based on trial data derived predominantly from patients without type 2 diabetes. This is despite the recognition that patients with type 2 diabetes may be relatively more tolerant of hyperglycaemia and more susceptible to hypoglycaemia. It is uncertain whether glucose targets should be more liberal in patients with type 2 diabetes.
OBJECTIVE


To detail the protocol, analysis and reporting plans for a randomised clinical trial - the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial - which will evaluate the risks and benefits of targeting a higher blood glucose range in patients with type 2 diabetes.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTION


A multicentre, parallel group, open label phase 2B randomised controlled clinical trial of 450 critically ill patients with type 2 diabetes. Patients will be randomised 1:1 to liberal blood glucose (target 10.0-14.0 mmol/L) or usual care (target 6.0-10.0 mmol/L).
MAIN OUTCOME MEASURES


The primary endpoint is incident hypoglycaemia (< 4.0 mmol/L) during the study intervention. Secondary endpoints include biochemical and feasibility outcomes.
RESULTS AND CONCLUSION


The study protocol and statistical analysis plan described will delineate conduct and analysis of the trial, such that analytical and reporting bias are minimised.
TRIAL REGISTRATION


This trial has been registered on the Australian New Zealand Clinical Trials Registry (ACTRN No. 12616001135404) and has been endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group.",2020,"To detail the protocol, analysis and reporting plans for a randomised clinical trial - the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial - which will evaluate the risks and benefits of targeting a higher blood glucose range in patients with type 2 diabetes.
","['450 critically ill patients with type 2 diabetes', 'intensive care unit (ICU) patients with type 2 diabetes', 'patients without type 2 diabetes', 'patients with type 2 diabetes', 'Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial', 'Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID']",['liberal blood glucose (target 10.0-14.0 mmol/L) or usual care (target 6.0-10.0 mmol/L'],"['biochemical and feasibility outcomes', 'incident hypoglycaemia']","[{'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0556994', 'cui_str': 'Lucid'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",450.0,0.153555,"To detail the protocol, analysis and reporting plans for a randomised clinical trial - the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial - which will evaluate the risks and benefits of targeting a higher blood glucose range in patients with type 2 diabetes.
","[{'ForeName': 'Alexis P', 'Initials': 'AP', 'LastName': 'Poole', 'Affiliation': 'Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia. Alexis.Poole@adelaide.edu.au.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Finnis', 'Affiliation': 'Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Anstey', 'Affiliation': 'Department of Intensive Care, Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'Department of Intensive and Critical Care Unit, Flinders Medical Centre, Adelaide, SA, Australia.'}, {'ForeName': 'Vishwanath', 'Initials': 'V', 'LastName': 'Biradar', 'Affiliation': 'Department of Intensive Care, Lyell McEwin Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Doherty', 'Affiliation': 'Department of Intensive Care, Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finfer', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'French', 'Affiliation': 'Department of Intensive Care, Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Angaj', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': 'Intensive Care Unit, Northern Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Heller', 'Affiliation': 'Clinical Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Palash', 'Initials': 'P', 'LastName': 'Kar', 'Affiliation': 'Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Kruger', 'Affiliation': 'Department of Intensive Care, Princess Alexandra Hospital, Brisbane, QLD, Australia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Maiden', 'Affiliation': 'Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Mårtensson', 'Affiliation': 'Section of Anaesthesia and Intensive Care Medicine, Department of Physiology and Pharmacology, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'McArthur', 'Affiliation': 'Department of Critical Care Medicine, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Shay P', 'Initials': 'SP', 'LastName': 'McGuinness', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care and High Dependency Unit, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Secombe', 'Affiliation': 'Department of Intensive Care, Alice Springs Hospital, Alice Springs, NT, Australia.'}, {'ForeName': 'Antony E', 'Initials': 'AE', 'LastName': 'Tobin', 'Affiliation': ""Department of Intensive Care, St Vincent's Hospital Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Udy', 'Affiliation': 'Department of Intensive Care, The Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Department of Intensive Care, Royal Melbourne Hospital, Melbourne, VIC, Australia. Adam.Deane@mh.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine,[]
185,32389147,Psychological and demographic characteristics of 368 patients with dissociative seizures: data from the CODES cohort.,"BACKGROUND


We examined demographic, clinical, and psychological characteristics of a large cohort (n = 368) of adults with dissociative seizures (DS) recruited to the CODES randomised controlled trial (RCT) and explored differences associated with age at onset of DS, gender, and DS semiology.
METHODS


Prior to randomisation within the CODES RCT, we collected demographic and clinical data on 368 participants. We assessed psychiatric comorbidity using the Mini-International Neuropsychiatric Interview (M.I.N.I.) and a screening measure of personality disorder and measured anxiety, depression, psychological distress, somatic symptom burden, emotional expression, functional impact of DS, avoidance behaviour, and quality of life. We undertook comparisons based on reported age at DS onset (<40 v. ⩾40), gender (male v. female), and DS semiology (predominantly hyperkinetic v. hypokinetic).
RESULTS


Our cohort was predominantly female (72%) and characterised by high levels of socio-economic deprivation. Two-thirds had predominantly hyperkinetic DS. Of the total, 69% had ⩾1 comorbid M.I.N.I. diagnosis (median number = 2), with agoraphobia being the most common concurrent diagnosis. Clinical levels of distress were reported by 86% and characteristics associated with maladaptive personality traits by 60%. Moderate-to-severe functional impairment, high levels of somatic symptoms, and impaired quality of life were also reported. Women had a younger age at DS onset than men.
CONCLUSIONS


Our study highlights the burden of psychopathology and socio-economic deprivation in a large, heterogeneous cohort of patients with DS. The lack of clear differences based on gender, DS semiology and age at onset suggests these factors do not add substantially to the heterogeneity of the cohort.",2020,"We assessed psychiatric comorbidity using the Mini-International Neuropsychiatric Interview (M.I.N.I.) and a screening measure of personality disorder and measured anxiety, depression, psychological distress, somatic symptom burden, emotional expression, functional impact of DS, avoidance behaviour, and quality of life.","['age at DS onset (<40 v. ⩾40), gender (male v. female), and DS semiology (predominantly hyperkinetic v. hypokinetic', 'patients with DS', '368 patients with dissociative seizures', 'large cohort (n = 368) of adults with dissociative seizures (DS', 'Women had a younger age at DS onset than men', 'Our cohort was predominantly female (72%) and characterised by high levels of socio-economic deprivation', '368 participants']",[],"['quality of life', 'maladaptive personality traits', 'personality disorder and measured anxiety, depression, psychological distress, somatic symptom burden, emotional expression, functional impact of DS, avoidance behaviour, and quality of life', 'Clinical levels of distress', 'psychiatric comorbidity']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233574', 'cui_str': 'Hyperkinetic'}, {'cui': 'C0086439', 'cui_str': 'Hypokinetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233851', 'cui_str': 'Maladaptive personality trait'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",368.0,0.231839,"We assessed psychiatric comorbidity using the Mini-International Neuropsychiatric Interview (M.I.N.I.) and a screening measure of personality disorder and measured anxiety, depression, psychological distress, somatic symptom burden, emotional expression, functional impact of DS, avoidance behaviour, and quality of life.","[{'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Robinson', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'John D C', 'Initials': 'JDC', 'LastName': 'Mellers', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Carson', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, UK.'}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Reuber', 'Affiliation': 'Academic Neurology Unit, Royal Hallamshire Hospital, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Eastwood', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Centre for Social Justice and Global Responsibility, School of Law and Social Sciences, London South Bank University, London, UK.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Mosweu', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Perdue', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Pilecka', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Richardson', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Medford', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychological medicine,['10.1017/S0033291720001051']
186,32402160,Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma.,"BACKGROUND


The combination of atezolizumab and bevacizumab showed encouraging antitumor activity and safety in a phase 1b trial involving patients with unresectable hepatocellular carcinoma.
METHODS


In a global, open-label, phase 3 trial, patients with unresectable hepatocellular carcinoma who had not previously received systemic treatment were randomly assigned in a 2:1 ratio to receive either atezolizumab plus bevacizumab or sorafenib until unacceptable toxic effects occurred or there was a loss of clinical benefit. The coprimary end points were overall survival and progression-free survival in the intention-to-treat population, as assessed at an independent review facility according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
RESULTS


The intention-to-treat population included 336 patients in the atezolizumab-bevacizumab group and 165 patients in the sorafenib group. At the time of the primary analysis (August 29, 2019), the hazard ratio for death with atezolizumab-bevacizumab as compared with sorafenib was 0.58 (95% confidence interval [CI], 0.42 to 0.79; P<0.001). Overall survival at 12 months was 67.2% (95% CI, 61.3 to 73.1) with atezolizumab-bevacizumab and 54.6% (95% CI, 45.2 to 64.0) with sorafenib. Median progression-free survival was 6.8 months (95% CI, 5.7 to 8.3) and 4.3 months (95% CI, 4.0 to 5.6) in the respective groups (hazard ratio for disease progression or death, 0.59; 95% CI, 0.47 to 0.76; P<0.001). Grade 3 or 4 adverse events occurred in 56.5% of 329 patients who received at least one dose of atezolizumab-bevacizumab and in 55.1% of 156 patients who received at least one dose of sorafenib. Grade 3 or 4 hypertension occurred in 15.2% of patients in the atezolizumab-bevacizumab group; however, other high-grade toxic effects were infrequent.
CONCLUSIONS


In patients with unresectable hepatocellular carcinoma, atezolizumab combined with bevacizumab resulted in better overall and progression-free survival outcomes than sorafenib. (Funded by F. Hoffmann-La Roche/Genentech; ClinicalTrials.gov number, NCT03434379.).",2020,"Overall survival at 12 months was 67.2% (95% CI, 61.3 to 73.1) with atezolizumab-bevacizumab and 54.6% (95% CI, 45.2 to 64.0) with sorafenib.","['patients with unresectable hepatocellular carcinoma who had not previously received systemic treatment', 'group and 165 patients in the sorafenib group', 'Unresectable Hepatocellular Carcinoma', '336 patients in the', 'patients with unresectable hepatocellular carcinoma']","['sorafenib', 'atezolizumab and bevacizumab', 'Atezolizumab plus Bevacizumab', 'atezolizumab-bevacizumab', 'atezolizumab plus bevacizumab or sorafenib', 'bevacizumab']","['overall and progression-free survival outcomes', 'Median progression-free survival', 'Grade 3 or 4 hypertension', 'Grade 3 or 4 adverse events', 'Overall survival', 'antitumor activity and safety', 'grade toxic effects', 'overall survival and progression-free survival', 'hazard ratio for death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.465943,"Overall survival at 12 months was 67.2% (95% CI, 61.3 to 73.1) with atezolizumab-bevacizumab and 54.6% (95% CI, 45.2 to 64.0) with sorafenib.","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ducreux', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Tae-You', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Valeriy', 'Initials': 'V', 'LastName': 'Breder', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Ahmed O', 'Initials': 'AO', 'LastName': 'Kaseb', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Daneng', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Verret', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Derek-Zhen', 'Initials': 'DZ', 'LastName': 'Xu', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Sairy', 'Initials': 'S', 'LastName': 'Hernandez', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Sohail', 'Initials': 'S', 'LastName': 'Mulla', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Yulei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': ""From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) - all in California; the People's Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai - all in China; National Cancer Center Hospital East, Kashiwa (M.I.), and Kindai University Faculty of Medicine, Osaka (M.K.) - both in Japan; University Medical Center Mainz, Mainz, Germany (P.R.G.); Gustave Roussy Cancer Center, Paris-Saclay University, Villejuif (M.D.), and University Hospital La Croix-Rousse, Lyon (P.M.) - both in France; Seoul National University College of Medicine (T.-Y.K.) and Samsung Medical Center, Sungkyunkwan University School of Medicine (H.Y.L.) - both in Seoul, South Korea; N.N. Blokhin Russian Cancer Research Center, Moscow (V.B.); the University of Texas M.D. Anderson Cancer Center, Houston (A.O.K.); Hoffmann-La Roche, Mississauga, ON, Canada (S.M.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.X.Z.); and the National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei (A.-L.C.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915745']
187,32398047,"Clinical efficacy of potassium canreonate-canrenone in sinus rhythm restoration among patients with atrial fibrillation - a protocol of a pilot, randomized, double -blind, placebo-controlled study (CANREN-AF trial).","BACKGROUND


Atrial fibrillation (AF) is the most frequent cardiac arrhythmia which increases the risk of thromboembolic complications and impairs quality of life. An important part of a therapeutic approach for AF is sinus rhythm restoration. Antiarrhythmic agents used in pharmacological cardioversion have limited efficacy and potential risk of proarrhythmia. Simultaneously, underlying conditions of AF should be treated (e.g. electrolyte imbalance, increased blood pressure, neurohormonal disturbances, atrial volume overload). There is still the need for an effective and safe approach to increase AF cardioversion efficacy. This randomized, double-blind, placebo-controlled, superiority clinical study is performed in patients with AF in order to evaluate the clinical efficacy of intravenous canrenone in sinus rhythm restoration.
METHODS


Eighty eligible patients with an episode of AF lasting less than 48 h are randomized in a 1:1 ratio to receive canrenone or placebo. Patients randomized to a treatment intervention are receiving canrenone intravenously at a dose of 200 mg within 2-3 min. Subjects assigned to a control group obtain the same volume of 0.9% saline within the same time. The primary endpoint includes return of sinus rhythm documented in the electrocardiogram within 2 h after drug or placebo administration. Other endpoints and safety outcomes analyses, due to expected lack of statistical power, are exploratory.
DISCUSSION


Current evidence supports renin-angiotensin-aldosterone system (RAAS) inhibition as an upstream therapy in AF management. Excess aldosterone secretion results in proarrhythmic effects. Among the RAAS inhibitors, only canrenone is administered intravenously. Canrenone additionally increases the plasma level of potassium, lowers blood pressure and reduces preload. It has been already used in primary and secondary hyperaldosteronism in the course of chronic liver dysfunction and in heart failure.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03536806. Registered on 25 May 2018.",2020,"Canrenone additionally increases the plasma level of potassium, lowers blood pressure and reduces preload.","['patients with atrial fibrillation - a protocol', 'Eighty eligible patients with an episode of AF lasting less than 48\u2009h are randomized in a 1:1 ratio to receive', 'patients with AF']","['intravenous canrenone', 'canrenone or placebo', 'canrenone', 'potassium canreonate-canrenone', 'placebo']","['blood pressure, neurohormonal disturbances, atrial volume overload', 'plasma level of potassium, lowers blood pressure and reduces preload', 'AF cardioversion efficacy', 'return of sinus rhythm documented in the electrocardiogram within 2\u2009h after drug or placebo administration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0006882', 'cui_str': 'Canrenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",80.0,0.350949,"Canrenone additionally increases the plasma level of potassium, lowers blood pressure and reduces preload.","[{'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Dąbrowski', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland. rdabrowski@ikard.pl.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Syska', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Mączyńska', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Farkowski', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sawicki', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Kubaszek-Kornatowska', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Michałek', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Kowalik', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Szwed', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Hryniewiecki', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}]",Trials,['10.1186/s13063-020-04277-3']
188,32398077,Effect of a postpartum family planning intervention on postpartum intrauterine device counseling and choice: evidence from a cluster-randomized trial in Tanzania.,"BACKGROUND


The World Health Organization recommends postpartum family planning (PPFP) for healthy birth spacing. This study is an evaluation of an intervention that sought to improve women's access to PPFP in Tanzania. The intervention included counseling on PPFP during antenatal and delivery care and introducing postpartum intrauterine device (PPIUD) insertion as an integrated part of delivery services for women electing PPIUD in the immediate postpartum period.
METHODS


This cluster-randomized controlled trial recruited 15,264 postpartum Tanzanian women aged 18 or older who delivered in one of five study hospitals between January and September 2016. We present the effectiveness of the intervention using a difference-in-differences approach to compare outcomes, receipt of PPIUD counseling and choice of PPIUD after delivery, between the pre- and post-intervention period in the treatment and control group. We also present an intervention adherence-adjusted analysis using an instrumental variables estimation.
RESULTS


We estimate linear probability models to obtain effect sizes in percentage points (pp). The intervention increased PPIUD counseling by 19.8 pp (95% CI: 9.1 - 22.6 pp) and choice of PPIUD by 6.3 pp (95% CI: 2.3 - 8.0 pp). The adherence-adjusted estimates demonstrate that if all women had been counseled, we would have observed a 31.6 pp increase in choice of PPIUD (95% CI: 24.3 - 35.8 pp). Among women counseled, determinants of choosing PPIUD included receiving an informational leaflet during counseling and being counseled after admission for delivery services.
CONCLUSIONS


The intervention modestly increased the rate of PPIUD counseling and choice of PPIUD, primarily due to low coverage of PPIUD counseling among women delivering in study facilities. With universal PPIUD counseling, large increases in choice of PPIUD would have been observed. Giving women informational materials on PPIUD and counseling after admission for delivery are likely to increase the proportion of women choosing PPIUD.
TRIAL REGISTRATION


Registered with clinicaltrials.gov (NCT02718222) on March 24, 2016, retrospectively registered.",2020,The intervention increased PPIUD counseling by 19.8 pp (95% CI: 9.1 - 22.6 pp) and choice of PPIUD by 6.3 pp (95% CI: 2.3 - 8.0 pp).,"['15,264 postpartum Tanzanian women aged 18 or older who delivered in one of five study hospitals between January and September 2016', 'healthy birth spacing', ""women's access to PPFP in Tanzania""]","['intervention included counseling on PPFP during antenatal and delivery care and introducing postpartum intrauterine device (PPIUD) insertion as an integrated part of delivery services', 'postpartum family planning intervention']","['rate of PPIUD counseling and choice of PPIUD, primarily due to low coverage of PPIUD counseling', 'PPIUD counseling']","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C1171257', 'cui_str': 'Delivery care'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",15264.0,0.213227,The intervention increased PPIUD counseling by 19.8 pp (95% CI: 9.1 - 22.6 pp) and choice of PPIUD by 6.3 pp (95% CI: 2.3 - 8.0 pp).,"[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Pearson', 'Affiliation': 'Ipas, Chapel Hill, NC, USA. pearsone@ipas.org.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Senderowicz', 'Affiliation': 'University of Wisconsin - Madison School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Pradhan', 'Affiliation': 'World Bank, Washington, DC, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Francis', 'Affiliation': 'Department of Family Medicine and Primary Care, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Projestine', 'Initials': 'P', 'LastName': 'Muganyizi', 'Affiliation': 'Association of Gynaecologists and Obstetricians of Tanzania (AGOTA), Dar es Salaam, Tanzania.'}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Shah', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Canning', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Karra', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'Nzovu', 'Initials': 'N', 'LastName': 'Ulenga', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",BMC women's health,['10.1186/s12905-020-00956-0']
189,32398091,A randomised controlled crossover trial investigating the short-term effects of different types of vegetables on vascular and metabolic function in middle-aged and older adults with mildly elevated blood pressure: the VEgetableS for vaScular hEaLth (VESSEL) study protocol.,"BACKGROUND


A diet rich in fruits and vegetables is recommended for cardiovascular health. However, the majority of Australians do not consume the recommended number of vegetable servings each day. Furthermore, intakes of vegetables considered to have the greatest cardiovascular benefit are often very low. Results from prospective observational studies indicate that a higher consumption of cruciferous vegetables (e.g. broccoli, cabbage, cauliflower) is associated with lower cardiovascular disease risk. This may be due to the presence of specific nutrients and bioactive compounds found almost exclusively, or at relatively high levels, in cruciferous vegetables. Therefore, the aim of this randomised controlled crossover trial is to determine whether regular consumption of cruciferous vegetables results in short-term improvement in measures related to cardiovascular disease risk, including ambulatory blood pressure, arterial stiffness, glycaemic control, and circulating biomarkers of oxidative stress and inflammation.
METHODS


Twenty-five participants (50-75 years) with mildly elevated blood pressure (systolic blood pressure 120-160 mmHg) will complete two 2-week intervention periods in random order, separated by a 2-week washout period. During the intervention period, participants will consume 4 servings (~ 300 g) of cruciferous vegetables per day as a soup (~ 500-600 mL/day). The 'control' soup will consist of other commonly consumed vegetables (potato, sweet potato, carrot, pumpkin). Both soups will be approximately matched for energy, protein, fat, and carbohydrate content. All measurements will be performed at the beginning and end of each intervention period.
DISCUSSION


The findings of this study will provide evidence regarding the potential cardiometabolic health benefits of cruciferous vegetables, which may contribute to the revision of dietary and clinical guidelines.
TRIAL REGISTRATION


The trial was registered with the Australian New Zealand Clinical Trial Registry on 19th September 2019 (ACTRN12619001294145).",2020,"METHODS


Twenty-five participants (50-75 years) with mildly elevated blood pressure (systolic blood pressure 120-160 mmHg) will complete two 2-week intervention periods in random order, separated by a 2-week washout period.","['Twenty-five participants (50-75\u2009years) with mildly elevated blood pressure (systolic blood pressure 120-160\u2009mmHg', 'middle-aged and older adults with mildly elevated blood pressure']","['cruciferous vegetables', 'regular consumption of cruciferous vegetables']","['vascular and metabolic function', 'ambulatory blood pressure, arterial stiffness, glycaemic control, and circulating biomarkers of oxidative stress and inflammation']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0453113', 'cui_str': 'Brassica vegetable'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",25.0,0.0701994,"METHODS


Twenty-five participants (50-75 years) with mildly elevated blood pressure (systolic blood pressure 120-160 mmHg) will complete two 2-week intervention periods in random order, separated by a 2-week washout period.","[{'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Connolly', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Catherine P', 'Initials': 'CP', 'LastName': 'Bondonno', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Radavelli-Bagatini', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Croft', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Boyce', 'Affiliation': 'Centre for Integrative Metabolomics and Computational Biology, School of Science, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'James', 'Affiliation': 'School of Public Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'School of Public Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Reindolf', 'Initials': 'R', 'LastName': 'Anokye', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Bondonno', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Devine', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Seng Khee', 'Initials': 'SK', 'LastName': 'Gan', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Schultz', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Mithen', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lewis', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hodgson', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Blekkenhorst', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia. l.blekkenhorst@ecu.edu.au.'}]",Nutrition journal,['10.1186/s12937-020-00559-3']
190,32398710,Metacognitive Therapy versus Cognitive Behaviour Therapy in Adults with Major Depression: A Parallel Single-Blind Randomised Trial.,"In the last forty years therapy outcomes for depression have remained the same with approximately 50% of patients responding to treatments. Advances are urgently required. We hypothesised that a recent treatment, metacognitive therapy (MCT), might be more effective, by targeting mental control processes that directly contribute to depression. We assessed the clinical efficacy of MCT compared to current best psychotherapy practice, CBT, in adults with major depressive disorder. A parallel randomized single-blind trial was conducted in a primary care outpatient setting. This trial is registered with the ISCRTN registry, number ISRCTN82799488. In total 174 adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder were eligible and consented to take part. 85 were randomly allocated to MCT and 89 to CBT. Randomisation was performed independently following pre-treatment assessment and was stratified for severity of depression (low < 20 vs high > =20) on the Hamilton Depression Rating Scale (HDRS) and on sex (male/female). Assessors and trial statisticians were blind to treatment allocation. Each treatment arm consisted of up to 24 sessions of up to 60 minutes each, delivered by trained clinical psychologists. The co-primary outcome measures were assessor rated symptom severity on the HDRS and self-reported symptom severity on the Beck Depression Inventory II (BDI-II) at post treatment. Secondary outcomes were scores six months post treatment on these measures and a range of symptom and mechanism variables. A key trial design feature was that each treatment was implemented to maximize individual patient benefit; hence time under therapy and number of sessions delivered could vary. Treated groups in the trial were very similar on most baseline characteristics. Data were analyzed on the basis of intention to treat (ITT). No differences were found on the HDRS at post treatment or follow-up (-0.95 [-2.88 to 0.98], p = 0.336; and -1.61 [-3.65 to 0.43], p = 0.122), but floor effects on this outcome were high. However, a significant difference favouring MCT was found on the BDI-II at post treatment (-5.49 [95% CI -8.90 to -2.08], p = 0.002), which was maintained at six-month follow-up (-4.64 [-8.21 to -1.06], p = 0.011). Following MCT 74% of patients compared with 52% in CBT met formal criteria for recovery on the BDI-II at post treatment (odds-ratio=2.42 [1.20 to 4.92], p = 0.014). At follow-up the proportions were 74% compared to 56% recovery (odds-ratio=2.19 [1.05 to 4.54], p = 0.036). Significant differences favouring MCT, also maintained over time, were observed for most secondary outcomes. The results were robust against controlling for time under therapy and when outcomes were assessed at a common 90 day mid-term time-point. Limitations of the study include the use of only two therapists where one treated 69% of patients, possible allegiance effects as the study was conducted in an established CBT clinic and the chief investigator is the originator of MCT and group differences in time under therapy. Never the less evidence from this study suggests that MCT had considerable beneficial effects in treating depression that may exceed CBT.",2020,Following MCT 74% of patients compared with 52% in CBT met formal criteria for recovery on the BDI-II at post treatment (odds-,"['In total 174 adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder were eligible and consented to take part', 'primary care outpatient setting', 'Adults with Major Depression', 'adults with major depressive disorder']","['metacognitive therapy (MCT', 'Metacognitive Therapy versus Cognitive Behaviour Therapy', 'MCT']","['range of symptom and mechanism variables', 'MCT', 'Hamilton Depression Rating Scale (HDRS', 'assessor rated symptom severity on the HDRS and self-reported symptom severity on the Beck Depression Inventory II (BDI-II', 'HDRS']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",174.0,0.0879843,Following MCT 74% of patients compared with 52% in CBT met formal criteria for recovery on the BDI-II at post treatment (odds-,"[{'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Callesen', 'Affiliation': 'Cektos - Center for Kognitiv - og Metakognitiv Terapi, Riddergade 7, 1 sal, 4700, Næstved, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reeves', 'Affiliation': 'University of Manchester, NIHR School for Primary Care Research, Manchester Academic Health Sciences Centre, Williamson Building, Manchester, M13 9PL, UK.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Heal', 'Affiliation': 'University of Manchester, Centre for Biostatistics, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, Manchester, M13 9PL, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wells', 'Affiliation': 'University of Manchester, School of Psychological Sciences, Faculty of Biology, Medicine and Health, Rawnsley Building, MRI, Manchester, M13 9WL, UK. adrian.wells@manchester.ac.uk.'}]",Scientific reports,['10.1038/s41598-020-64577-1']
191,32384478,Clinical study of XiangShaLiuJunZi decoction combined with S-1 as maintenance therapy for stage III or IV gastric carcinoma and colorectal carcinoma.,"INTRODUCTION


S-1, a new oral fluorouracil chemotherapeutical drug, has been increasingly used in clinical maintenance after first-line chemotherapy for stage III or IV gastric carcinoma (GC) and colorectal carcinoma (CRC) for its own advantages. XiangshaLiujunzi Decoction (XSLJZD), a classic traditional Chinese medicine (TCM) formula with effects of alleviating the adverse reactions of chemotherapy and improving the quality of life of cancer patients has been gradually confirmed, with no more reports about the maintenance therapy mode of combination of chemotherapeutic drugs and TCM. We designed the study of XSLJZD combined with S-1 in the maintenance therapy of Stage III or IV GC and CRC, and hoped that this research program will go further and comprehensively evaluate its efficacy and safety.
OBJECTIVES


The aim of this study was to determine the efficacy and safety of XSLJZD combined with S-1 in the maintenance therapy of stage III or IV GC and CRC.
METHODS


This study is an open, single-center, randomized study. Patients with stage III or stage IV GC and CRC will be randomized (1:1) into S-1group, S-1 combined with XSLJZD group for 5 years of maintenance therapy. The primary endpoint was progression-free survival, and secondary end point was overall survival and Quality of Life Assessment (QOLA), which include an improvement in symptoms before and after treatment, Karnofsky Performance Status, and adverse events assessment.
DISCUSSION


This study will provide meaningful clinical information about the combination of chemotherapeutic drugs S-1 with TCM in the maintenance therapy of stage III or IV GC and CRC.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR-INR-16008575.",2020,"formula with effects of alleviating the adverse reactions of chemotherapy and improving the quality of life of cancer patients has been gradually confirmed, with no more reports about the maintenance therapy mode of combination of chemotherapeutic drugs and TCM.","['stage III or IV gastric carcinoma (GC) and colorectal carcinoma (CRC', 'Patients with stage III or stage IV GC and CRC', 'cancer patients', 'stage III or IV gastric carcinoma and colorectal carcinoma']","['XSLJZD combined with S-1', 'TCM', 'XiangShaLiuJunZi decoction combined with S-1', 'S-1group, S-1 combined with XSLJZD', 'XiangshaLiujunzi Decoction (XSLJZD), a classic traditional Chinese medicine (TCM']","['quality of life', 'efficacy and safety', 'progression-free survival', 'overall survival and Quality of Life Assessment (QOLA), which include an improvement in symptoms before and after treatment, Karnofsky Performance Status, and adverse events assessment']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0699791', 'cui_str': 'Carcinoma of stomach'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C3884575', 'cui_str': 'Xiangshaliujunzi decoction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0439658', 'cui_str': 'Classic'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0857071,"formula with effects of alleviating the adverse reactions of chemotherapy and improving the quality of life of cancer patients has been gradually confirmed, with no more reports about the maintenance therapy mode of combination of chemotherapeutic drugs and TCM.","[{'ForeName': 'Xiao-Cui', 'Initials': 'XC', 'LastName': 'Hong', 'Affiliation': 'Oncology Center, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China.'}, {'ForeName': 'Qi-Lian', 'Initials': 'QL', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Xing-Bo', 'Initials': 'XB', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Ke-Hui', 'Initials': 'KH', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Hai-Xia', 'Initials': 'HX', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Wen-Ting', 'Initials': 'WT', 'LastName': 'Ou', 'Affiliation': ''}, {'ForeName': 'Hui-Jie', 'Initials': 'HJ', 'LastName': 'Zhang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020081']
192,32385058,Cluster randomised controlled trial of home cook intervention to reduce salt intake in China: a protocol study.,"INTRODUCTION


Salt intake in China is twice the upper limit recommended by the WHO, and nearly 80% of salt is added during cooking. This study will develop a package of salt reduction interventions targeting home cooks and evaluate its effectiveness and feasibility for scale-up.
METHODS AND ANALYSIS


A cluster randomised controlled trial design is adopted in this study, which will be conducted in six provinces covering northern, central and southern China. For each province, 10 communities/villages (clusters) with 13 families (one cook and one adult family member) will be selected in each cluster for evaluation. In total, 780 home cooks and 780 adult family members will be recruited. The home cooks in the intervention group will be provided with the intervention package, including community-based standardised offline and online health education and salt intake monitoring. The duration of the intervention will be 1 year. The primary outcome is the difference between the intervention and control group in change in salt intake as measured by 24 hours urinary sodium from baseline to the end of the trial. The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).
ETHICS AND DISSEMINATION


The study has been approved by The Queen Mary Research Ethics Committee (QMERC2018/13) and Institutional Review Board of the Chinese Center for Disease Control and Prevention (No. 201801). The study findings will be disseminated widely through conference presentations and peer-reviewed publications and the general media.
TRIAL REGISTRATION NUMBER


ChiCTR1800016804.",2020,"The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).
","['For each province, 10 communities/villages (clusters) with 13 families (one cook and one adult family member', 'China', 'six provinces covering northern, central and southern China', 'In total, 780 home cooks and 780 adult family members will be recruited']","['intervention package, including community-based standardised offline and online health education and salt intake monitoring', 'home cook intervention']","['change in salt intake', 'change in salt-related knowledge, attitude and practice and blood pressure (BP']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.101015,"The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).
","[{'ForeName': 'Xiaochang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Beijing Center for Diseases Prevention and Control, Beijing, China.'}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China majx@chinacdc.cn zpuhong@georgeinstitute.org.cn.'}, {'ForeName': 'Puhong', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China majx@chinacdc.cn zpuhong@georgeinstitute.org.cn.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Luo', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Feng J', 'Initials': 'FJ', 'LastName': 'He', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'MacGregor', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jinglei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zhaoxue', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2019-033842']
193,32386395,Δ 9 -Tetrahydrocannabinol (THC) impairs visual working memory performance: a randomized crossover trial.,"With the increasing prevalence of legal cannabis use and availability, there is an urgent need to identify cognitive impairments related to its use. It is widely believed that cannabis, or its main psychoactive component Δ 9 -tetrahydrocannabinol (THC), impairs working memory, i.e., the ability to temporarily hold information in mind. However, our review of the literature yielded surprisingly little empirical support for an effect of THC or cannabis on working memory. We thus conducted a study with three main goals: (1) quantify the effect of THC on visual working memory in a well-powered sample, (2) test the potential role of cognitive effects (mind wandering and metacognition) in disrupting working memory, and (3) demonstrate how insufficient sample size and task duration reduce the likelihood of detecting a drug effect. We conducted two double-blind, randomized crossover experiments in which healthy adults (N = 23, 23) performed a reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC (7.5 and/or 15 mg oral) or placebo. We also assessed self-reported ""mind wandering"" (Exp 1) and metacognitive accuracy about ongoing task performance (Exp 2). THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2). Thus, our findings indicate that THC does impair visual working memory, and that this impairment may be related to both increased mind wandering and decreased monitoring of task performance. Finally, we used a down-sampling procedure to illustrate the effects of task length and sample size on power to detect the acute effect of THC on working memory.",2020,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","['healthy adults (N\u2009=\u200923, 23) performed a']","['THC', 'reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC', 'placebo', 'Tetrahydrocannabinol (THC']","['metacognitive accuracy about task performance', 'THC impaired working memory performance', 'visual working memory', 'visual working memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.14689,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","[{'ForeName': 'Kirsten C S', 'Initials': 'KCS', 'LastName': 'Adam', 'Affiliation': 'Department of Psychology, University of California San Diego, San Diego, CA, USA. kadam@ucsd.edu.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Doss', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pabon', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Vogel', 'Affiliation': 'Grossman Institute for Neuroscience, Quantitative Biology, and Human Behavior, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0690-3']
194,32386418,Influence of Provider Communication on Emerging Adults' Medication Cognitions and Provider Satisfaction.,"OBJECTIVE


This study examined how the content of medical provider communication related to medication prescriptions influenced emerging adults' (EA) medication-related cognitions and satisfaction with care.
METHODS


In total, 257 EA (ages 18-25) were randomized to one of three audio vignettes depicting a medical appointment in which the EA imagined him/herself as the recipient of an oral antibiotic prescription. Provider communication content varied by vignette as follows: the positive outcome expectancy (POE) vignette focused on enhancing patient POE related to antibiotic use; the negative outcome expectancy (NOE) vignette focused on reducing patient NOE; and the standard care vignette focused on providing factual medication information. Following the vignette, participants self-reported on demographics, select medication-related cognitions, and provider satisfaction from vignette.
RESULTS


Those in the NOE vignette condition reported higher provider satisfaction, perceived the provider to have given more information, and evidenced lower NOE and higher POE about the antibiotic compared with those in the other conditions. Intent to adhere did not vary by vignette condition.
CONCLUSIONS


Brief, provider-initiated communication focused on reducing patient NOE may have unique value in altering EA's medication-related cognitions. Given that medication-related beliefs are known correlates of adherence, future research should replicate and expand these findings in the context of real-world medical encounters and through the utilization of objective indices of medication adherence to more fully understand the potential significance of provider language emphasizing reduction of NOE on medication adherence.",2020,"Intent to adhere did not vary by vignette condition.
","['In total, 257 EA (ages 18-25']","['Provider Communication', 'audio vignettes depicting a medical appointment in which the EA imagined him/herself as the recipient of an oral antibiotic prescription']",['provider satisfaction'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",257.0,0.0202149,"Intent to adhere did not vary by vignette condition.
","[{'ForeName': 'Samantha A', 'Initials': 'SA', 'LastName': 'Carreon', 'Affiliation': ""Texas Children's Hospital/Baylor College of Medicine.""}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Durkin', 'Affiliation': 'Rosalind Franklin University of Medicine and Science.'}, {'ForeName': 'W Hobart', 'Initials': 'WH', 'LastName': 'Davies', 'Affiliation': 'University of Wisconsin-Milwaukee.'}, {'ForeName': 'Rachel Neff', 'Initials': 'RN', 'LastName': 'Greenley', 'Affiliation': 'Rosalind Franklin University of Medicine and Science.'}]",Journal of pediatric psychology,['10.1093/jpepsy/jsaa022']
195,32387042,"Anti-inflammatory effects of lenabasum, a cannabinoid receptor type 2 agonist, on macrophages from cystic fibrosis.","BACKGROUND


Lenabasum is an oral synthetic cannabinoid receptor type 2 agonist previously shown to reduce the production of key airway pro-inflammatory cytokines known to play a role in cystic fibrosis (CF). In a double-blinded, randomized, placebo-control phase 2 study, lenabasum lowered the rate of pulmonary exacerbation among patients with CF. The present study was undertaken to investigate anti-inflammatory mechanisms of lenabasum exhibits in CF macrophages.
METHODS


We used monocyte-derived macrophages (MDMs) from healthy donors (n = 15), MDMs with CFTR inhibited with C-172 (n = 5) and MDMs from patients with CF (n = 4). Monocytes were differentiated to macrophages and polarized into classically activated (M1) macrophages by LPS or alternatively activated (M2) macrophages by IL-13 in presence or absence of lenabasum.
RESULTS


Lenabasum had no effect on differentiation, polarization and function of macrophages from healthy individuals. However, in CF macrophages lenabasum downregulated macrophage polarization into the pro-inflammatory M1 phenotype and secretion of the pro-inflammatory cytokines IL-8 and TNF-α in a dose-dependent manner. An improvement in phagocytic activity was also observed following lenabasum treatment. Although lenabasum did not restore the impaired polarization of anti-inflammatory M2 macrophage, it reduced the levels of IL-13 and enhanced the endocytic function of CF MDMs. The effects of lenabasum on MDMs with CFTR inhibited by C-172 were not as obvious.
CONCLUSION


In CF macrophages lenabasum modulates macrophage polarization and function in vitro in a way that would reduce inflammation in vivo. Further studies are warranted to determine the link between activating the CBR2 receptor and CFTR.",2020,"Although lenabasum did not restore the impaired polarization of anti-inflammatory M2 macrophage, it reduced the levels of IL-13 and enhanced the endocytic function of CF MDMs.","['healthy donors (n\xa0=\xa015), MDMs with CFTR inhibited with', 'patients with CF']","['C-172', 'placebo']","['rate of pulmonary exacerbation', 'differentiation, polarization and function of macrophages', 'phagocytic activity']","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}]","[{'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0429742,"Although lenabasum did not restore the impaired polarization of anti-inflammatory M2 macrophage, it reduced the levels of IL-13 and enhanced the endocytic function of CF MDMs.","[{'ForeName': 'Abdullah A', 'Initials': 'AA', 'LastName': 'Tarique', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Tama', 'Initials': 'T', 'LastName': 'Evron', 'Affiliation': 'Corbus Pharmaceuticals, Inc., Norwood, MA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Corbus Pharmaceuticals, Inc., Norwood, MA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Tepper', 'Affiliation': 'Corbus Pharmaceuticals, Inc., Norwood, MA, USA.'}, {'ForeName': 'Mohammed M', 'Initials': 'MM', 'LastName': 'Morshed', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Isabella S G', 'Initials': 'ISG', 'LastName': 'Andersen', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Nelufa', 'Initials': 'N', 'LastName': 'Begum', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Sly', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia. Electronic address: p.sly@uq.edu.au.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Fantino', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.03.015']
196,32387091,The clinical utility of apoB versus LDL-C/non-HDL-C.,"BACKGROUND


The ESC/EAS Guidelines and the EAS/EFLM consensus reports state that apoB is a more accurate marker of cardiovascular risk than LDL-C or non-HDL-C and that apoB can be measured accurately and precisely than LDL-C or non-HDL-C. Nevertheless, EAS/EFLM called for a randomized clinical trial and a cost-effective analysis before widespread implementation of apoB.
OBJECTIVE


To analyse these issues from the perspective of clinical utility as clinical utility would be considered by an informed patient and physician.
METHODS AND RESULTS


We highlight the biological inaccuracies as well as the laboratory inaccuracies of LDL-C/non-HDL-C versus apoB. We demonstrate why the biological variance in the cholesterol loading per apoB particle makes it impossible to design a randomized clinical trial to compare apoB to LDL-C/non-HDL-C. We further demonstrate that even in the context of the United States, adding apoB to a lipid panel would have only a trivial effect on costs.
CONCLUSION


We submit that no informed patient or physician would choose a less accurate test over a more accurate test if the more accurate test added only trivially to the total cost of care. For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.",2020,"For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.",[],['apoB versus LDL-C/non-HDL-C'],[],[],"[{'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",[],,0.0221709,"For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.","[{'ForeName': 'Ciaran N', 'Initials': 'CN', 'LastName': 'Kohli-Lynch', 'Affiliation': 'Division of General Medicine, Columbia University Medical Center, New York, NY, USA; Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thanassoulis', 'Affiliation': 'Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Division of Cardiology, Royal Victoria Hospital - McGill University Health Centre, 1001 Decarie Boulevard, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Moran', 'Affiliation': 'Division of General Medicine, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Sniderman', 'Affiliation': 'Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Division of Cardiology, Royal Victoria Hospital - McGill University Health Centre, 1001 Decarie Boulevard, Montreal, Quebec, Canada. Electronic address: allansniderman@hotmail.com.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.05.001']
197,32387209,"Invited commentary on ""The effect of increased abdominal pressure on internal jugular vein catheterization under ultrasound-guidance on conscious patients: A randomised controlled trial"".",,2020,,['conscious patients'],['internal jugular vein catheterization under ultrasound-guidance'],[],"[{'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]",[],,0.0620143,,"[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Tian', 'Affiliation': 'Department of Critical Care Medicine, Qingpu Branch of Zhongshan Hospital, Fudan University, Shanghai, 201700, China.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Wuhan Hospital of Traditional Chinese Medicine, Hubei, 430014, China. Electronic address: dhp19651226@126.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.04.073']
198,32388538,Serotonin differentially modulates the temporal dynamics of the limbic response to facial emotions in male adults with and without autism spectrum disorder (ASD): a randomised placebo-controlled single-dose crossover trial.,"Emotion processing-including signals from facial expressions-is often altered in individuals with autism spectrum disorder (ASD). The biological basis of this is poorly understood but may include neurochemically mediated differences in the responsivity of key 'limbic' regions (including amygdala, ventromedial prefrontal cortex (vmPFC) and nucleus accumbens (NAc)). Emerging evidence also suggests that ASD may be a disorder of brain temporal dynamics. Moreover, serotonin (5-HT) has been shown to be a key regulator of both facial-emotion processing and brain dynamics, and 5-HT abnormalities have been consistently implicated in ASD. To date, however, no one has examined how 5-HT influences the dynamics of facial-emotion processing in ASD. Therefore, we compared the influence of 5-HT on the responsivity of brain dynamics during facial-emotion processing in individuals with and without ASD. Participants completed a facial-emotion processing fMRI task at least 8 days apart using a randomised double-blind crossover design. At each visit they received either a single 20-mg oral dose of the selective serotonin reuptake inhibitor (SSRI) citalopram or placebo. We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults. The neurotypical adults' limbic response reverted more rapidly to baseline following a 5-HT-challenge. Our results suggest that serotonergic homoeostatic control of the temporal dynamics in limbic regions is altered in adults with ASD, and provide a fresh perspective on the biology of ASD.",2020,We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults.,"['individuals with autism spectrum disorder (ASD', 'individuals with and without ASD', 'male adults with and without autism spectrum disorder (ASD', 'adults with ASD']","['serotonin (5-HT', 'citalopram', 'Serotonin', 'selective serotonin reuptake inhibitor (SSRI) citalopram or placebo', 'Emotion processing-including signals from facial expressions', '5-HT', 'placebo']",['facial-emotion processing fMRI task'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",,0.311869,We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults.,"[{'ForeName': 'Nichol M L', 'Initials': 'NML', 'LastName': 'Wong', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. nichol.wong@kcl.ac.uk.""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Findon', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Wichers', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Giampietro', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Vladimira', 'Initials': 'V', 'LastName': 'Stoencheva', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Clodagh M', 'Initials': 'CM', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Blainey', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ecker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Goethe University Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Declan G', 'Initials': 'DG', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Grainne M', 'Initials': 'GM', 'LastName': 'McAlonan', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0693-0']
199,32393279,Protocols of a diagnostic study and a randomized controlled non-inferiority trial comparing televisits vs standard in-person outpatient visits for narcolepsy diagnosis and care: TElemedicine for NARcolepsy (TENAR).,"BACKGROUND


Narcolepsy is a rare chronic sleep disorder that typically begins in youth. Excessive daytime sleepiness is the main disabling symptom, but the disease is often associated with severe endocrine-metabolic and psychosocial issues, worsened by a long diagnostic delay, requiring a multidisciplinary approach. The scarcity of reference Sleep Centres forces the patient and family to travel for seeking medical consultations, increasing the economic and psychosocial burden of the disease. Growing evidence suggests that Telemedicine may facilitate patient access to sleep consultations and its non-inferiority in terms of patient satisfaction, adherence to treatment, and symptom improvement for sleep disorders. However, Telemedicine clinical and economic benefits for patients with narcolepsy are still unknown.
METHODS


TENAR is a two-part project, including: 1. a cross-sectional study (involving 250 children and adults with suspected narcolepsy) evaluating the accuracy of Teletriage (i.e., a synchronous live interactive sleep assessment through a Televisit) for narcolepsy diagnosis compared to the reference standard; and 2. a two-arm, parallel, open randomized controlled trial (RCT) to demonstrate the non-inferiority of the multidisciplinary care of narcolepsy through Televisits versus standard care. In this RCT, 202 adolescents (> 14 y.o.) and adults with narcolepsy will be randomly allocated (1:1 ratio) either to Televisits via videoconference or to standard in-person outpatient follow-up visits (control arm). The primary outcome is sleepiness control (according to the Epworth Sleepiness Scale). Secondary outcomes are other symptoms control, compliance with treatment, metabolic control, quality of life, feasibility, patient and family satisfaction with care, safety, and disease-related costs. At baseline and at 12 months, patients will undergo neurologic, metabolic, and psychosocial assessments and we will measure primary and secondary outcomes. Primary outcomes will be also measured at 6 months (remotely or in person, according to the arm).
DISCUSSION


TENAR project will assess, for the first time, the feasibility, accuracy, efficacy and safety of Telemedicine procedures applied to the diagnosis and the multidisciplinary care of children and adults with narcolepsy. The study may be a model for the remote management of other rare disorders, offering care access for patients living in areas lacking medical centres with specific expertise.
TRIAL REGISTRATION


Number of the Tele-multidisciplinary care study NCT04316286. Registered 20 March 2020.",2020,"Growing evidence suggests that Telemedicine may facilitate patient access to sleep consultations and its non-inferiority in terms of patient satisfaction, adherence to treatment, and symptom improvement for sleep disorders.","['person outpatient visits for narcolepsy diagnosis and care: TElemedicine for NARcolepsy (TENAR', '202 adolescents (>\u200914 y.o.) and adults with narcolepsy', 'children and adults with narcolepsy', 'patients with narcolepsy', '250 children and adults with suspected narcolepsy', 'patients living in areas lacking medical centres with specific expertise']","['Televisits via videoconference or to standard in-person outpatient follow-up visits (control arm', 'synchronous live interactive sleep assessment through a Televisit', 'Telemedicine']","['6\u2009months (remotely or in person, according to the arm', 'symptoms control, compliance with treatment, metabolic control, quality of life, feasibility, patient and family satisfaction with care, safety, and disease-related costs', 'sleepiness control (according to the Epworth Sleepiness Scale', 'Excessive daytime sleepiness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}]",250.0,0.120184,"Growing evidence suggests that Telemedicine may facilitate patient access to sleep consultations and its non-inferiority in terms of patient satisfaction, adherence to treatment, and symptom improvement for sleep disorders.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ingravallo', 'Affiliation': 'Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Vignatelli', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy. l.vignatelli@ausl.bologna.it.'}, {'ForeName': 'Uberto', 'Initials': 'U', 'LastName': 'Pagotto', 'Affiliation': 'Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Vandi', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Moresco', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Mangiaruga', 'Affiliation': 'Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Oriolo', 'Affiliation': 'Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Zenesini', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Pizza', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Plazzi', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}]",BMC neurology,['10.1186/s12883-020-01762-9']
200,32393300,"The effect of music therapy on pain, anxiety and depression in patients after coronary artery bypass grafting.","OBJECTIVE


The purpose of this study was to explore the effects of music therapy on pain, anxiety and depression in patients after coronary artery bypass grafting.
METHODS


A retrospective study of 99 patients after coronary artery bypass from January 2017 to January 2019 was conducted in a cardiac center in China. According to the different interventions, all the participants were divided into 3 groups: group A: music therapy; group B: rest without music therapy; and group C: conventional treatment. The Numerical Rating Scale (NRS), Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) were used to measure the patient's pain, anxiety and depression before and after 30 min of the intervention.
RESULTS


There were no significant differences in the NRS, SDS and SAS scores between the three groups of patients before the intervention. After 30 min of music therapy, the NRS, SDS and SAS scores of patients in group A were significantly lower than those before music therapy, and the differences were statistically significant. However, before and after the intervention in groups B and C, the NRS, SDS and SAS scores were not statistically significant. By comparison among the three groups after 30 min of intervention, the NRS, SDS and SAS scores in patients in group A were significantly lower than those in groups B and C, and the differences were statistically significant. The scores were not significantly different between groups B and C.
CONCLUSION


Music therapy can effectively alleviate the pain, anxiety and depression of patients after coronary artery bypass grafting.",2020,"There were no significant differences in the NRS, SDS and SAS scores between the three groups of patients before the intervention.","['99 patients after coronary artery bypass from January 2017 to January 2019 was conducted in a cardiac center in China', 'patients after coronary artery bypass grafting']","['music therapy', 'music therapy; group B: rest without music therapy; and group C: conventional treatment', 'Music therapy']","[""patient's pain, anxiety and depression"", 'pain, anxiety and depression', 'Numerical Rating Scale (NRS), Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS', 'NRS, SDS and SAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",99.0,0.0155104,"There were no significant differences in the NRS, SDS and SAS scores between the three groups of patients before the intervention.","[{'ForeName': 'Wang-Sheng', 'Initials': 'WS', 'LastName': 'Dai', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. chenqiang2228@163.com.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. caohua0791@163.com.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01141-y']
201,32393320,"Usual care including home exercise with versus without spa therapy for chronic low back pain: protocol for the LOMBATHERM' study, a multicentric randomised controlled trial.","BACKGROUND


Low back pain is highly prevalent and a major source of disability worldwide. Spa therapy is frequently used to treat low back pain, but the associated level of evidence for efficacy is insufficient. To fill this knowledge gap, this protocol proposes an appropriately powered, prospective, evaluator-blinded, multi-centre, two-parallel-arm, randomised (1:1), controlled trial that will compare spa therapy in addition to usual care including home exercise (UCHE) versus UCHE alone for the treatment of chronic low back pain.
METHODS


Eligible patients (anticipated sample size of 358) will have had low back pain for more than 3 months and scores for pain greater than 40 mm on a visual analogue scale (VAS). Following initial consent for UCHE and baseline evaluations, patients are randomised (1:1) to UCHE alone, or UCHE plus spa therapy (18 days of mud packs, underwater massages, showers and water exercises under medical supervision). Patients in the latter arm will be requested to sign an additional consent form as per Zelen randomisation. Follow-up visits will occur at approximately months 1, 6 and 12 and (along with baseline assessments) will cover changes over time in VAS pain scores, the impact of lower back pain on daily life (the Rolland and Morris Disability Questionnaire (RMDQ)), inappropriate fears and beliefs about lower back pain (the fear, avoidance, belief questionnaire (FABQ)), general quality of life (the Euroqol Group 5 dimension, 5 level questionnaire (EQ-5D-5 L)), Patient Acceptable Symptom State (PASS), consumption of analgesic drugs and nonsteroidal anti-inflammatory drugs (NSAIDs), and overall state of health. Health resource use and days of sick leave (and subsequently the associated costs) will also be recorded. The primary outcome is the presence/absence of a clinically relevant change (improvement of at least 30%) in the VAS score for pain at 6 months.
DISCUSSION


Despite the fact that previous, rather dated recommendations encourage spa therapy for the treatment of low back pain, the current literary corpus is methodologically poor. This protocol has been designed to provide results spanning a thorough range of outcomes at the highest evidence level possible.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03910023. Registered on 10 April 2019.",2020,"The primary outcome is the presence/absence of a clinically relevant change (improvement of at least 30%) in the VAS score for pain at 6 months.
","['Eligible patients (anticipated sample size of 358) will have had low back pain for more than 3\u2009months and scores for pain greater than 40\u2009mm on a visual analogue scale (VAS', 'chronic low back pain']","['Usual care including home exercise with versus without spa therapy', 'Spa therapy', 'UCHE alone, or UCHE plus spa therapy', 'usual care including home exercise (UCHE) versus UCHE alone']","['VAS score for pain', 'presence/absence of a clinically relevant change', 'VAS pain scores, the impact of lower back pain on daily life (the Rolland and Morris Disability Questionnaire (RMDQ)), inappropriate fears and beliefs about lower back pain (the fear, avoidance, belief questionnaire (FABQ)), general quality of life (the Euroqol Group 5 dimension, 5 level questionnaire (EQ-5D-5\u2009L)), Patient Acceptable Symptom State (PASS), consumption of analgesic drugs and nonsteroidal anti-inflammatory drugs (NSAIDs), and overall state of health']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0450402', 'cui_str': '40mm'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",358.0,0.216203,"The primary outcome is the presence/absence of a clinically relevant change (improvement of at least 30%) in the VAS score for pain at 6 months.
","[{'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Forestier', 'Affiliation': 'Centre de Recherche Rhumatologique et Thermal, 15 avenue Charles de Gaulle, 73100, Aix-les-Bains, France. romain.forestier@wanadoo.fr.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Suehs', 'Affiliation': 'Departments of Medical Information and Respiratory Diseases, Univ Montpellier, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Françon', 'Affiliation': 'Centre de Recherche Rhumatologique et Thermal, 15 avenue Charles de Gaulle, 73100, Aix-les-Bains, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Marty', 'Affiliation': 'Department of Rheumatology, APHP - Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Genevay', 'Affiliation': 'Department of Rheumatology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Sellam', 'Affiliation': 'Department of Rheumatology, APHP - Hôpital Saint-Antoine, Sorbonne Université, Inserm URMS_938, Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Chauveton', 'Affiliation': 'Delegation for Clinical Research and Innovation, Univ Montpellier, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Fatma Begüm', 'Initials': 'FB', 'LastName': 'Erol Forestier', 'Affiliation': 'Centre de Recherche Rhumatologique et Thermal, 15 avenue Charles de Gaulle, 73100, Aix-les-Bains, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Molinari', 'Affiliation': 'IMAG, CNRS, Univ Montpellier, CHU Montpellier, Montpellier, France.'}]",Trials,['10.1186/s13063-020-04271-9']
202,32387962,"Long-term treatment of chronic orofacial, pudendal, and central neuropathic limb pain with repetitive transcranial magnetic stimulation of the motor cortex.","OBJECTIVE


To assess the long-term analgesic effects of high-frequency repetitive transcranial magnetic stimulation (rTMS) of the motor cortex in patients with chronic pain syndrome.
METHODS


The study included 57 patients (orofacial pain, n = 26, pudendal neuralgia, n = 18, and neuropathic limb pain, n = 13) with an ""induction phase"" of 12 daily rTMS sessions for 3 weeks, followed by a ""maintenance phase"" of bi-monthly sessions for the next five months.
RESULTS


All pain measures significantly decreased from baseline to the end of the induction phase. Analgesic response, defined as pain intensity decrease ≥ 30% compared to baseline, was observed in 39 patients (68%), who could be differentiated from non-responders from the 7th rTMS session. At the end of the maintenance phase (D180), 27 patients (47%) were still responders. Anxio-depressive symptoms and quality of life also improved. The analgesic response at the end of the induction phase was associated with lower pain score at baseline, and the response at the end of the maintenance phase was associated with lower anxio-depressive score at baseline.
CONCLUSION


The analgesic efficacy of motor cortex rTMS can be maintained in the long term in various chronic pain conditions. Patients with high pain level and severe anxio-depressive symptoms may have a less favorable profile to respond to the procedure.
SIGNIFICANCE


The overall impact of rTMS treatment on daily life requires a multidimensional evaluation that goes beyond the analgesic effect that can be achieved.",2020,All pain measures significantly decreased from baseline to the end of the induction phase.,"['patients with chronic pain syndrome', '57 patients (orofacial pain, n\xa0=\xa026, pudendal neuralgia, n\xa0=\xa018, and neuropathic limb pain, n\xa0=\xa013) with an ""induction phase"" of 12 daily rTMS sessions for 3\xa0weeks, followed by a ""maintenance phase"" of bi-monthly sessions for the next five months', 'Patients with high pain level and severe anxio-depressive symptoms']","['high-frequency repetitive transcranial magnetic stimulation (rTMS', 'repetitive transcranial magnetic stimulation', 'rTMS', 'motor cortex rTMS']","['pain intensity decrease\xa0≥', 'anxio-depressive score', 'Anxio-depressive symptoms and quality of life', 'analgesic response', 'lower pain score', 'Analgesic response', 'All pain measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1298685', 'cui_str': 'Chronic pain syndrome'}, {'cui': 'C0178782', 'cui_str': 'Orofacial Pain'}, {'cui': 'C1997249', 'cui_str': 'Pudendal neuralgia'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",57.0,0.0662332,All pain measures significantly decreased from baseline to the end of the induction phase.,"[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Hodaj', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France; Grenoble Alpes University, Grenoble Institut Neurosciences, GIN, F-38000 Grenoble, France. Electronic address: HHodaj@chu-grenoble.fr.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Payen', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France; Grenoble Alpes University, Grenoble Institut Neurosciences, GIN, F-38000 Grenoble, France.'}, {'ForeName': 'Enkelejda', 'Initials': 'E', 'LastName': 'Hodaj', 'Affiliation': ""Centre d'Investigation Clinique, CHU Grenoble Alpes, F-38000 Grenoble, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Dumolard', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Maindet', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Cracowski', 'Affiliation': ""Centre d'Investigation Clinique, CHU Grenoble Alpes, F-38000 Grenoble, France.""}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Delon-Martin', 'Affiliation': 'Grenoble Alpes University, Grenoble Institut Neurosciences, GIN, F-38000 Grenoble, France.'}, {'ForeName': 'Jean-Pascal', 'Initials': 'JP', 'LastName': 'Lefaucheur', 'Affiliation': 'EA 4391, Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor, Université Paris Est Créteil, Créteil, France.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.03.022']
203,32389740,Administration of commensal Shewanella sp. MR-7 ameliorates lipopolysaccharide-induced intestine dysfunction in turbot (Scophthalmus maximus L.).,"This study was designed to evaluate whether the administration of commensal Shewanella sp. MR-7 (MR-7) could ameliorate lipopolysaccharide (LPS)-induced intestine dysfunction in turbot. Fish (body weight: 70.00 ± 2.00 g) were randomly divided into three groups including the control group treated with dough, the LPS group treated with dough plus LPS, and the LPS+MR-7 (LMR) group treated with dough plus LPS and MR-7. These three groups with 24 fish each were force-fed with 1 g dough daily for 7 continuous days. The results revealed that MR-7 administration ameliorated LPS-induced intestinal injury, showing higher intestinal villus and microvillus height. Further results showed that MR-7 could inhibit LPS-induced activation of TLR-NF-κB signaling thus maintaining the normal expression levels of cytokines and finally ameliorate the intestinal inflammatory response in turbot. Compared with the LPS group, LMR group had less goblet cells and lower mucin-2 expression level. Moreover, MR-7 restored LPS-induced down-regulation of tight junction protein-related gene expression (zonula occluden-1, occludin, tricellulin and claudin-3). Further investigations indicated that MR-7 partially counteracted LPS-induced changes in gut microbiota composition, enhanced the beneficial bacteria Lactobacillus and reduced the Pseudomonas, thus maintaining the overall microbiota balance. Taken together, the administration of MR-7 could effectively restore LPS-induced intestine function disorder in turbot by ameliorating inflammatory response, mucosal barrier dysfunction and microbiota dysbiosis.",2020,"Moreover, MR-7 restored LPS-induced down-regulation of tight junction protein-related gene expression (zonula occluden-1, occludin, tricellulin and claudin-3).",[],"['control group treated with dough, the LPS group treated with dough plus LPS, and the LPS+MR-7 (LMR) group treated with dough plus LPS and MR-7', 'commensal Shewanella sp. MR-7', 'LPS', 'LMR', 'MR-7']","['gut microbiota composition', 'overall microbiota balance', 'intestinal villus and microvillus height', 'goblet cells and lower mucin-2 expression level']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0542329', 'cui_str': 'Commensal parasite'}, {'cui': 'C0579220', 'cui_str': 'Shewanella'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0227266', 'cui_str': 'Intestinal villus'}, {'cui': 'C0026049', 'cui_str': 'Microvillus'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0506994', 'cui_str': 'Goblet Cells'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1528289', 'cui_str': 'MUC2 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.019845,"Moreover, MR-7 restored LPS-induced down-regulation of tight junction protein-related gene expression (zonula occluden-1, occludin, tricellulin and claudin-3).","[{'ForeName': 'Beili', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Chaoqun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Chengdong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Kangsen', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'He', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China; Laboratory for Marine Fisheries Science and Food Production Processes, Qingdao National Laboratory for Marine Science and Technology, Qingdao, 266237, China. Electronic address: hegen@ouc.edu.cn.'}]",Fish & shellfish immunology,['10.1016/j.fsi.2020.04.068']
204,32389808,Rationale and study design for lifestyle intervention in preparation for pregnancy (LIPP): A randomized controlled trial.,"INTRODUCTION


Maternal obesity increases neonatal risk for obesity and metabolic syndrome later in life. Prior attempts to break this intergenerational obesity cycle by limiting excessive gestational weight gain have failed to reduce neonatal adiposity. Alternatively, pre-conception lifestyle interventions may improve the in utero metabolic milieu during early pregnancy leading to improved fetal outcomes. This randomized controlled trial (RCT) is evaluating whether a lifestyle intervention to reduce weight and improve maternal metabolism in preparation for pregnancy (LIPP) attenuates neonatal adiposity, compared to standard medical advice.
MATERIAL AND METHODS


Overweight/class 1 obese women after a previous pregnancy, ~12 weeks postpartum, preparing for a subsequent pregnancy, will be block randomized (1:1) to either LIPP or standard of care in a parallel design. Randomization is stratified by lactation status and overweight vs. class 1 obesity. The LIPP program consists of intensive short-term weight loss followed by weight maintenance until conception using supervised exercise and a low glycemic Mediterranean diet.
PRIMARY OUTCOMES


Group differences in neonatal adiposity at birth assessed by PEA POD and placental mitochondrial lipid metabolism.
SECONDARY OUTCOMES


Group differences in maternal pregravid and gestational body composition, insulin sensitivity, β-cell function, fasting metabolic and inflammatory biomarkers, and overall quality of life. Exploratory outcomes include umbilical cord blood insulin resistance, lipid profile and inflammation.
DISCUSSION


This RCT will determine the efficacy of maternal weight loss prior to pregnancy on reducing neonatal adiposity. Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.
CLINICAL TRIAL REGISTRATION


NCT03146156.",2020,"Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.
","['pregnancy (LIPP', 'Overweight/class 1 obese women after a previous pregnancy, ~12', 'women planning for pregnancy']","['LIPP', 'lifestyle intervention']","['umbilical cord blood insulin resistance, lipid profile and inflammation', 'maternal pregravid and gestational body composition, insulin sensitivity, β-cell function, fasting metabolic and inflammatory biomarkers, and overall quality of life', 'utero metabolic milieu', 'neonatal adiposity at birth assessed by PEA POD and placental mitochondrial lipid metabolism']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",1.0,0.119724,"Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.
","[{'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Erickson', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Mey', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America; Department of Translational Services, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gordesky', 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Russell', 'Affiliation': 'Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Barkoukis', 'Affiliation': 'Department of Nutrition, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH 44106, United States of America.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': ""O'Tierney-Ginn"", 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, 711 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America. Electronic address: John.Kirwan@pbrc.edu.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Catalano', 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America. Electronic address: pcatalano@tuftsmedicalcenter.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106024']
205,32393129,Copayment Reduction Voucher Utilization and Associations With Medication Persistence and Clinical Outcomes: Findings From the ARTEMIS Trial.,"BACKGROUND


Cost is frequently cited as a barrier to optimal medication use, but the extent to which copayment assistance interventions are used when available, and their impact on evidence-based medication persistence and major adverse cardiovascular events is unknown.
METHODS AND RESULTS


The ARTEMIS trial (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) randomized 301 hospitals to usual care versus the ability to provide patients with vouchers that offset copayment costs when filling P2Y 12  inhibitors in the 1 year post-myocardial infarction. In the intervention group, we used multivariable logistic regression to identify patient and medication cost characteristics associated with voucher use. We then used this model to stratify both intervention and usual care patients by likelihood of voucher use, and examined the impact of the voucher intervention on 1-year P2Y 12  inhibitor persistence (no gap in pharmacy supply >30 days) and major adverse cardiovascular events (all-cause death, myocardial infarction, or stroke). Among 10 102 enrolled patients, 6135 patients were treated at hospitals randomized to the copayment intervention. Of these, 1742 (28.4%) never used the voucher, although 1729 (99.2%) voucher never-users filled at least one P2Y 12  inhibitor prescription in the 1 year post-myocardial infarction. Characteristics most associated with voucher use included: discharge on ticagrelor, planned 1-year course of P2Y 12  inhibitor treatment, white race, commercial insurance, and higher out-of-pocket medication costs (c-statistic 0.74). Applying this propensity model to stratify all enrolled patients by likelihood of voucher use, the intervention improved medication persistence the most in patients with high likelihood of voucher use (adjusted interaction  P =0.03, odds ratio, 1.86 [95% CI, 1.48-2.33]). The intervention did not significantly reduce major adverse cardiovascular events in any voucher use likelihood group, although the odds ratio was lowest (0.86 [95% CI, 0.56-1.16]) among patients with high likelihood of voucher use (adjusted interaction  P =0.04).
CONCLUSIONS


Among patients discharged after myocardial infarction, those with higher copayments and greater out-of-pocket medication costs were more likely to use a copayment assistance voucher, but some classes of patients were less likely to use a copayment assistance voucher. Patients at low likelihood of voucher use benefitted least from copayment assistance, and other interventions may be needed to improve medication-taking behaviors and clinical outcomes in these patients. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02406677.",2020,"The intervention did not significantly reduce major adverse cardiovascular events in any voucher use likelihood group, although the odds ratio was lowest (0.86 [95% CI, 0.56-1.16]) among patients with high likelihood of voucher use (adjusted interaction  P =0.04).
","['301 hospitals to usual care versus the ability to provide patients with vouchers that offset copayment costs when filling P2Y 12  inhibitors in the 1 year post-myocardial infarction', '10 102 enrolled patients, 6135 patients were treated at hospitals randomized to the copayment intervention']",[],"['major adverse cardiovascular events (all-cause death, myocardial infarction, or stroke', 'major adverse cardiovascular events']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",10102.0,0.0693459,"The intervention did not significantly reduce major adverse cardiovascular events in any voucher use likelihood group, although the odds ratio was lowest (0.86 [95% CI, 0.56-1.16]) among patients with high likelihood of voucher use (adjusted interaction  P =0.04).
","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Fanaroff', 'Affiliation': 'Penn Cardiovascular Outcomes, Quality and Evaluative Research Center, Leonard Davis Institute of Health Economics, Cardiovascular Medicine Division, University of Pennsylvania, Philadelphia (A.C.F.).'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Division of Cardiology (E.D.P., T.Y.W.), Duke University, Durham, NC.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kaltenbach', 'Affiliation': 'the Duke Clinical Research Institute (E.D.P., L.A.K., K.J.A., T.Y.W.), Duke University, Durham, NC.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'the Duke Clinical Research Institute (E.D.P., L.A.K., K.J.A., T.Y.W.), Duke University, Durham, NC.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Division of Cardiology, Ronald Reagan UCLA Medical Center, Los Angeles, CA (G.C.F.).'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, OH (T.D.H.).'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Division of Cardiology (C.P.P.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Niteesh K', 'Initials': 'NK', 'LastName': 'Choudhry', 'Affiliation': ""Center for Healthcare Delivery Sciences, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine (N.K.C.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City School of Medicine, Kansas City, MO (D.J.C.).'}, {'ForeName': 'Nipun', 'Initials': 'N', 'LastName': 'Atreja', 'Affiliation': 'AstraZeneca, Wilmington, DE (N.A., N.B., J.M.E.).'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Bhalla', 'Affiliation': 'AstraZeneca, Wilmington, DE (N.A., N.B., J.M.E.).'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Eudicone', 'Affiliation': 'AstraZeneca, Wilmington, DE (N.A., N.B., J.M.E.).'}, {'ForeName': 'Tracy Y', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiology (E.D.P., T.Y.W.), Duke University, Durham, NC.'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006182']
206,32393169,Does the revised intubating laryngeal tube (ILTS-D2) perform better than the intubating laryngeal mask (Fastrach)? - a randomised simulation research study.,"BACKGROUND


The intubating laryngeal tube (ILTS-D™) and the intubating laryngeal mask (Fastrach™) are devices that facilitate both extraglottic application and blind tracheal intubation. A revised model of the iLTS-D (for scientific reasons called ILTS-D2) has been designed but not yet evaluated. Therefore, we compared the ILTS-D2 with the established Fastrach under controlled conditions in a prospective randomised controlled simulation research study.
METHODS


After ethical approval, we randomised 126 medical students into two groups. Each participant received either Fastrach or ILTS-D2 to perform five consecutive ventilation attempts in a manikin. The primary endpoint was the time to ventilation in the last attempt of using the devices as extraglottic devices. Secondary endpoints were the time to tracheal intubation and the success rates.
RESULTS


There was no relevant difference between the two devices in the time to ventilation in the last of five attempts (Fastrach: median 14 s [IQR: 12-15]; ILTS-D2: median 13 s [IQR: 12-15], p = 0.592). Secondary endpoints showed a 2 s faster blind tracheal intubation using the Fastrach than using the ILTS-D2 (Fastrach: median 14 s [IQR: 13-17]; ILTS-D2: median 16 s [IQR: 15-20] p < 0.001). For both devices, the success rates were 100% in the last attempt.
CONCLUSIONS


Concerning extraglottic airway management, we could not detect a relevant difference between the revised ILTS-D2 and the Fastrach under laboratory conditions. We advocate for an evaluation of the ILTS-D2 in randomised controlled clinical trials.
TRIAL REGISTRATION


Identifier at clinicaltrials.gov: NCT03542747. May 31, 2018.",2020,Secondary endpoints showed a 2 s faster blind tracheal intubation using the Fastrach than using the ILTS-D2 (Fastrach: median 14 s [IQR: 13-17]; ILTS-D2: median 16 s [IQR: 15-20] p < 0.001).,['126 medical students into two groups'],"['intubating laryngeal tube (ILTS-D™) and the intubating laryngeal mask (Fastrach™', 'Fastrach or ILTS-D2']","['2\u2009s faster blind tracheal intubation using the Fastrach', 'time to tracheal intubation and the success rates', 'time to ventilation', 'time to ventilation in the last attempt of using the devices as extraglottic devices', 'success rates']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}]","[{'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",,0.115281,Secondary endpoints showed a 2 s faster blind tracheal intubation using the Fastrach than using the ILTS-D2 (Fastrach: median 14 s [IQR: 13-17]; ILTS-D2: median 16 s [IQR: 15-20] p < 0.001).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ott', 'Affiliation': 'Department of Anaesthesiology, Medical Centre of the Johannes Gutenberg University, Langenbeckstr. 1, 55131, Mainz, Germany. ottth@uni-mainz.de.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Tschöpe', 'Affiliation': 'Department of Anaesthesiology, Medical Centre of the Johannes Gutenberg University, Langenbeckstr. 1, 55131, Mainz, Germany.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Toenges', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology, and Informatics, Medical Centre of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Buggenhagen', 'Affiliation': 'Rudolf-Frey Lernklinik Central Education Platform, Medical Centre of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Engelhard', 'Affiliation': 'Department of Anaesthesiology, Medical Centre of the Johannes Gutenberg University, Langenbeckstr. 1, 55131, Mainz, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kriege', 'Affiliation': 'Department of Anaesthesiology, Medical Centre of the Johannes Gutenberg University, Langenbeckstr. 1, 55131, Mainz, Germany.'}]",BMC anesthesiology,['10.1186/s12871-020-01029-3']
207,32393216,"The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain.","BACKGROUND


Low back pain is a prevalent condition that causes a substantial health burden. Despite intensive and expensive clinical efforts, its prevalence is growing. Nonpharmacologic treatments are effective at improving pain-related outcomes; however, treatment effect sizes are often modest. Physical therapy (PT) and cognitive behavioral therapy (CBT) have the most consistent evidence of effectiveness. Growing evidence also supports mindfulness-based approaches. Discussions with providers and patients highlight the importance of discussing and trying options to find the treatment that works for them and determining what to do when initial treatment is not successful. Herein, we present the protocol for a study that will evaluate evidence-based, protocol-driven treatments using PT, CBT, or mindfulness to examine comparative effectiveness and optimal sequencing for patients with chronic low back pain.
METHODS


The Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain (OPTIMIZE) Study will be a multisite, comparative effectiveness trial using a sequential multiple assessment randomized trial design enrolling 945 individuals with chronic low back pain. The co-primary outcomes will be disability (measured using the Oswestry Disability Index) and pain intensity (measured using the Numerical Pain Rating Scale). After baseline assessment, participants will be randomly assigned to PT or CBT. At week 10, participants who have not experienced at least 50% improvement in disability will be randomized to cross-over phase-1 treatments (e.g., PT to CBT) or to Mindfulness-Oriented Recovery Enhancement (MORE). Treatment will consist of 8 weekly sessions. Long-term outcome assessments will be performed at weeks 26 and 52.
DISCUSSION


Results of this study may inform referring providers and patients about the most effective nonoperative treatment and/or sequence of nonoperative treatments to treat chronic low back pain.
TRIAL REGISTRATION


This study was prospectively registered on March 1, 2019, with Clinicaltrials.gov under the registration number NCT03859713 (https://clinicaltrials.gov/ct2/show/NCT03859713).",2020,The Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain (OPTIMIZE),"['945 individuals with chronic low back pain', 'chronic, nonspecific low back pain', 'patients with chronic low back pain']","['Physical therapy (PT) and cognitive behavioral therapy (CBT', 'nonpharmacologic treatment']","['disability', 'disability (measured using the Oswestry Disability Index) and pain intensity (measured using the Numerical Pain Rating Scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",945.0,0.158168,The Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain (OPTIMIZE),"[{'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Skolasky', 'Affiliation': 'Department of Orthopaedic Surgery, The Johns Hopkins University School of Medicine, 601 N. Caroline St, Baltimore, MD, 21287, USA. rskolas1@jhmi.edu.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Wegener', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The Johns Hopkins University School of Medicine, 601 N. Caroline St, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Rachel V', 'Initials': 'RV', 'LastName': 'Aaron', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The Johns Hopkins University School of Medicine, 601 N. Caroline St, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Patti', 'Initials': 'P', 'LastName': 'Ephraim', 'Affiliation': 'Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Brennan', 'Affiliation': 'Intermountain Healthcare, 36\u2009S State St, Salt Lake City, UT, 84111, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': ""Department of Population Health Sciences, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lane', 'Affiliation': ""Department of Physical Therapy and Athletic Training, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Minick', 'Affiliation': 'Intermountain Healthcare, 36\u2009S State St, Salt Lake City, UT, 84111, USA.'}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Hanley', 'Affiliation': ""College of Social Work, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA.""}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': ""College of Social Work, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA.""}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Fritz', 'Affiliation': ""Department of Physical Therapy and Athletic Training, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA.""}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03324-z']
208,32393220,Digital versus analogue chest drainage system in patients with primary spontaneous pneumothorax: a randomized controlled trial.,"BACKGROUND


Patients with a primary spontaneous pneumothorax (PSP) who are treated with chest tube drainage are traditionally connected to an analogue chest drainage system, containing a water seal and using a visual method of monitoring air leakage. Electronic systems with continuous digital monitoring of air leakage provide better insight into actual air leakage and changes in leakage over time, which may lead to a shorter length of hospital stay.
METHODS


We performed a randomized controlled trial comparing the digital with analogue system, with the aim of demonstrating that use of a digital drainage system in PSP leads to a shorter hospital stay.
RESULTS


In 102 patients enrolled with PSP we found no differences in total duration of chest tube drainage and hospital stay between the groups. However, in a post-hoc analysis, excluding 19 patients needing surgery due to prolonged air leakage, hospital stay was significantly shorter in the digital group (median 1 days, IQR 1-5 days) compared to the analogue group (median 3 days, IQR 2-5 days) (p 0.014). Treatment failure occurred in 3 patients in both groups; the rate of recurrence within 12 weeks was not significantly different between groups (16% in the digital group versus 8% in the analogue group, p 0.339).
CONCLUSION


Length of hospital stay was not shorter in patients with PSP when applying a digital drainage system compared to an analogue drainage system. However, in the large subgroup of uncomplicated PSP, a significant reduction in duration of drainage and hospital stay was demonstrated with digital drainage. These findings suggest that digital drainage may be a practical alternative to manual aspiration in the management of PSP.
TRIAL REGISTRATION


Registered 22 September 2013 - Retrospectively registered, Trial NL4022 (NTR4195).",2020,Length of hospital stay was not shorter in patients with PSP when applying a digital drainage system compared to an analogue drainage system.,"['102 patients enrolled with', 'Patients with a primary spontaneous pneumothorax (PSP) who are treated with', 'patients with primary spontaneous pneumothorax']","['chest tube drainage', 'PSP', 'Digital versus analogue chest drainage system']","['Treatment failure', 'Length of hospital stay', 'total duration of chest tube drainage and hospital stay', 'rate of recurrence', 'prolonged air leakage, hospital stay', 'duration of drainage and hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868193', 'cui_str': 'Primary spontaneous pneumothorax'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1868193', 'cui_str': 'Primary spontaneous pneumothorax'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0333257', 'cui_str': 'Air leakage'}]",102.0,0.12327,Length of hospital stay was not shorter in patients with PSP when applying a digital drainage system compared to an analogue drainage system.,"[{'ForeName': 'Dieuwertje', 'Initials': 'D', 'LastName': 'Ruigrok', 'Affiliation': 'Department of Pulmonary Medicine, Spaarne Gasthuis, PO Box 417 2000, AK, Haarlem, the Netherlands.'}, {'ForeName': 'Peter W A', 'Initials': 'PWA', 'LastName': 'Kunst', 'Affiliation': 'Department of Pulmonary Medicine, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Marielle M J', 'Initials': 'MMJ', 'LastName': 'Blacha', 'Affiliation': 'Department of Pulmonary Medicine, Spaarne Gasthuis, PO Box 417 2000, AK, Haarlem, the Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Tomlow', 'Affiliation': 'Department of Pulmonary Medicine, NWZG, Alkmaar, The Netherlands.'}, {'ForeName': 'Jacobine W', 'Initials': 'JW', 'LastName': 'Herbrink', 'Affiliation': 'Department of Pulmonary Medicine, Spaarne Gasthuis, PO Box 417 2000, AK, Haarlem, the Netherlands.'}, {'ForeName': 'Eva J', 'Initials': 'EJ', 'LastName': 'Japenga', 'Affiliation': 'Department of Pulmonary Medicine, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Boersma', 'Affiliation': 'Department of Pulmonary Medicine, NWZG, Alkmaar, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bresser', 'Affiliation': 'Department of Pulmonary Medicine, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'van der Lee', 'Affiliation': 'Department of Pulmonary Medicine, Spaarne Gasthuis, PO Box 417 2000, AK, Haarlem, the Netherlands.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Mooren', 'Affiliation': 'Department of Pulmonary Medicine, Spaarne Gasthuis, PO Box 417 2000, AK, Haarlem, the Netherlands. k.mooren@spaarnegasthuis.nl.'}]",BMC pulmonary medicine,['10.1186/s12890-020-1173-3']
209,32393245,Using alcohol consumption diary data from an internet intervention for outcome and predictive modeling: a validation and machine learning study.,"BACKGROUND


Alcohol use disorder (AUD) is highly prevalent and presents a large treatment gap. Self-help internet interventions are an attractive approach to lowering thresholds for seeking help and disseminating evidence-based programs at scale. Internet interventions for AUD however suffer from high attrition and since continuous outcome measurements are uncommon, little is known about trajectories and processes. The current study investigates whether data from a non-mandatory alcohol consumption diary, common in internet interventions for AUD, approximates drinks reported at follow-up, and whether data from the first half of the intervention predict treatment success.
METHODS


N = 607 participants enrolled in a trial of online self-help for AUD, made an entry in the non-mandatory consumption diary (total of 9117 entries), and completed the follow-up assessment. Using multiple regression and a subset of calendar data overlapping with the follow-up, scaling factors were derived to account for missing entries per participant and week. Generalized estimating equations with an inverse time predictor were then used to calculate point-estimates of drinks per week at follow-up, the confidence intervals of which were compared to that from the measurement at follow-up. Next, calendar data form the first half of the intervention were retained and summary functions used to create 18 predictors for random forest machine learning models, the classification accuracies of which were ultimately estimated using nested cross-validation.
RESULTS


While the raw calendar data substantially underestimated drinks reported at follow-up, the confidence interval of the trajectory-derived point-estimate from the adjusted data overlapped with the confidence interval of drinks reported at follow-up. Machine learning models achieved prediction accuracies of 64% (predicting non-hazardous drinking) and 48% (predicting AUD severity decrease), in both cases with higher sensitivity than specificity.
CONCLUSIONS


Data from a non-mandatory alcohol consumption diary, adjusted for missing entries, approximates follow-up data at a group level, suggesting that such data can be used to reveal trajectories and processes during treatment and possibly be used to impute missing follow-up data. At an individual level, however, calendar data from the first half of the intervention did not have high predictive accuracy, presumable due to a high rate of missing data and unclear missing mechanisms.",2020,"Machine learning models achieved prediction accuracies of 64% (predicting non-hazardous drinking) and 48% (predicting AUD severity decrease), in both cases with higher sensitivity than specificity.
","['N\xa0', '607 participants enrolled in a trial of online self-help for AUD, made an entry in the non-mandatory consumption diary (total of 9117 entries), and completed the follow-up assessment']",['Self-help internet interventions'],['prediction accuracies'],"[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}]",607.0,0.047745,"Machine learning models achieved prediction accuracies of 64% (predicting non-hazardous drinking) and 48% (predicting AUD severity decrease), in both cases with higher sensitivity than specificity.
","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Lindner', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden. philip.lindner@ki.se.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Johansson', 'Affiliation': 'Center for Dependency Disorders, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Gajecki', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Berman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}]",BMC medical research methodology,['10.1186/s12874-020-00995-z']
210,32393252,Metabolic effects of PCSK9 inhibition with Evolocumab in subjects with elevated Lp(a).,"BACKGROUND


Epidemiological studies substantiated that subjects with elevated lipoprotein(a) [Lp(a)] have a markedly increased cardiovascular risk. Inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) lowers both LDL cholesterol (LDL-C) as well as Lp(a), albeit modestly. Effects of PCSK9 inhibition on circulating metabolites such as lipoprotein subclasses, amino acids and fatty acids remain to be characterized.
METHODS


We performed nuclear magnetic resonance (NMR) metabolomics on plasma samples derived from 30 individuals with elevated Lp(a) (> 150 mg/dL). The 30 participants were randomly assigned into two groups, placebo (N = 14) and evolocumab (N = 16). We assessed the effect of 16 weeks of evolocumab 420 mg Q4W treatment on circulating metabolites by running lognormal regression analyses, and compared this to placebo. Subsequently, we assessed the interrelationship between Lp(a) and 14 lipoprotein subclasses in response to treatment with evolocumab, by running multilevel multivariate regression analyses.
RESULTS


On average, evolocumab treatment for 16 weeks resulted in a 17% (95% credible interval: 8 to 26%, P < 0.001) reduction of circulating Lp(a), coupled with substantial reduction of VLDL, IDL and LDL particles as well as their lipid contents. Interestingly, increasing concentrations of baseline Lp(a) were associated with larger reduction in triglyceride-rich VLDL particles after evolocumab treatment.
CONCLUSIONS


Inhibition of PCSK9 with evolocumab markedly reduced VLDL particle concentrations in addition to lowering LDL-C. The extent of reduction in VLDL particles depended on the baseline level of Lp(a). Our findings suggest a marked effect of evolocumab on VLDL metabolism in subjects with elevated Lp(a).
TRIAL REGISTRATION


Clinical trial registration information is registered at ClinicalTrials.gov on April 14, 2016 with the registration number NCT02729025.",2020,"Inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) lowers both LDL cholesterol (LDL-C) as well as Lp(a), albeit modestly.","['subjects with elevated Lp(a', 'subjects with elevated lipoprotein(a) [Lp(a', '30 individuals with elevated Lp(a) (>\u2009150\u2009mg/dL', '30 participants']","['proprotein convertase subtilisin/kexin type 9 (PCSK9', 'PCSK9 inhibition', 'evolocumab 420\u2009mg Q4W treatment', 'PCSK9 inhibition with Evolocumab', 'evolocumab', 'nuclear magnetic resonance (NMR) metabolomics', 'placebo']","['cardiovascular risk', 'LDL cholesterol (LDL-C', 'triglyceride-rich VLDL particles', 'concentrations of baseline Lp(a', 'VLDL particle concentrations', 'VLDL metabolism', 'VLDL, IDL and LDL particles', 'circulating Lp(a']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0523559', 'cui_str': 'IDL cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",30.0,0.409188,"Inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) lowers both LDL cholesterol (LDL-C) as well as Lp(a), albeit modestly.","[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Experimental Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. xiang.zhang@wur.nl.'}, {'ForeName': 'Lotte C A', 'Initials': 'LCA', 'LastName': 'Stiekema', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Albert K', 'Initials': 'AK', 'LastName': 'Groen', 'Affiliation': 'Department of Experimental Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}]",Lipids in health and disease,['10.1186/s12944-020-01280-0']
211,32393274,"Secondary surgical cytoreduction needs to be assessed taking into account surgical technique, completeness of cytoreduction, and extent of disease.","Recent evidence suggested that secondary surgical cytoreduction followed by chemotherapy does not result in longer overall survival in patients with platinum-sensitive recurrent ovarian cancer.This statement is based on a phase III multicenter, randomized clinical trial that lacks a description of the surgical protocol, the surgical technique, and the surgical variables. In a study that evaluates surgical cytoreduction, it is mandatory to assess the grade of cytoreductive surgery achieved (Sugarbaker PH, Langenbeck's Arch Surg 384:576-87, 1999), the extent of disease using PCI (Peritoneal Cancer Index), the technique itself, and the existence of a multidisciplinary approach with extensive upper abdominal procedures in experienced centers (Ren et al, BMC Cancer 15:1-12, 2015). There is evidence proving that the quality of cytoreduction (Al Rawahi et al, Cochrane Database Syst Rev 2013, 2013), the measurement of the amount of disease by PCI (Elzarkaa et al, J Gynecol Oncol 29, 2018), and a multidisciplinary approach with supramesocolic procedures (Ren et al, BMC Cancer 15:1-12, 2015) impact overall survival.This study fails to compare chemotherapy with secondary cytoreductive surgery since, due to the lack of variables, we can assess neither the performed surgery nor its criteria. This study should not be taken into account to recommend chemotherapy alone over a surgical approach in this group of patients.",2020,Recent evidence suggested that secondary surgical cytoreduction followed by chemotherapy does not result in longer overall survival in patients with platinum-sensitive recurrent ovarian cancer.,['patients with platinum-sensitive recurrent ovarian cancer'],[],['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0724334,Recent evidence suggested that secondary surgical cytoreduction followed by chemotherapy does not result in longer overall survival in patients with platinum-sensitive recurrent ovarian cancer.,"[{'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Segura-Sampedro', 'Affiliation': 'Department of General and Digestive Surgery, Son Espases University Hospital, Spain, 07010 Palma de Mallorca, Spain. Health Research Institute of the Balearic Islands (IdISBa), Palma de Mallorca, Spain. School of Medicine, University of the Balearic Islands (UIB), Palma de Mallorca, Spain. segusamjj@gmail.com.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Morales-Soriano', 'Affiliation': 'Department of General and Digestive Surgery, Son Espases University Hospital, Spain, 07010 Palma de Mallorca, Spain. Health Research Institute of the Balearic Islands (IdISBa), Palma de Mallorca, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Arjona-Sánchez', 'Affiliation': 'General & Digestive Surgery Department, University Hospital Reina Sofía, School of Medicine, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cascales-Campos', 'Affiliation': 'General & Digestive Surgery Department, University Hospital Virgen de la Arrixaca, School of Medicine, University of Murcia, Murcia, Spain.'}]",World journal of surgical oncology,['10.1186/s12957-020-01853-4']
212,32330670,Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) to increase evidence based psychotherapy in military behavioral health clinics: Design of a cluster-randomized stepped-wedge implementation study.,"BACKGROUND


Despite efforts by the U.S. Department of Defense to train behavioral health (BH) providers in evidence-based psychotherapies (EBPs) for posttraumatic stress disorder (PTSD), numerous barriers limit EBP implementation. A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities. TACTICS combines a needs assessment, a rubric for selecting implementation strategies based on local barriers, an implementation toolkit, and external facilitation to support local champions and their implementation teams in enacting changes. This paper describes the rationale for and design of a study that will evaluate whether TACTICS can increase implementation of PE for PTSD and improve patient outcomes in military BH clinics relative to provider training in PE alone.
METHODS


The study is a multi-site, cluster randomized, stepped-wedge trial, with the military treatment facility as the unit of analysis. Eight facilities undergo a provider-training phase, followed by 5 months of TACTICS implementation. The timing of TACTICS at each facility is randomly assigned to begin 9, 14, or 19 months after beginning the provider-training phase. Primary analyses will compare the proportion of PTSD patients receiving PE and patients' mean improvement in PTSD symptoms before and after the onset of TACTICS.
DISCUSSION


TACTICS endeavors to balance standardization of empirically-supported implementation strategies with the flexibility of application necessary for success across varied clinical settings. If successful, TACTICS may represent a systematic and scalable method of promoting and supporting EBP implementation.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier: NCT03663452.",2020,A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities.,"['military BH clinics relative to provider training in PE alone', 'military behavioral health clinics']",[],['PTSD symptoms'],"[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]",[],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0549177,A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities.,"[{'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Rosen', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America; Department of Psychiatry and Behavioral Sciences, Stanford University, 401 Quarry Rd, Palo Alto, CA 94305, United States of America. Electronic address: craig.rosen@va.gov.'}, {'ForeName': 'C Adrian', 'Initials': 'CA', 'LastName': 'Davis', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America. Electronic address: carrie.davis6@va.gov.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Riggs', 'Affiliation': 'Center for Deployment Psychology, Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD 20814, United States of America. Electronic address: driggs@deploymentpsych.org.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Center for Deployment Psychology, Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD 20814, United States of America. Electronic address: jcook@deploymentpsych.org.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America; Research and Development Service, South Texas Veterans Health Care System, 7400 Merton Minter Blvd, San Antonio, TX 78229, United States of America; Department of Psychology, University of Texas at San Antonio, One UTSA Circle, San Antonio, TX 78249, United States of America. Electronic address: petersona3@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America. Electronic address: youngs1@uthscsa.edu.'}, {'ForeName': 'Katherine Anne', 'Initials': 'KA', 'LastName': 'Comtois', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, 1959 NE Pacific St, Seattle, WA 98195, United States of America. Electronic address: kcomtois@uw.edu.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Haddock', 'Affiliation': 'Social Sciences Innovations Corporation, 71 W 23rd St 4th Floor, New York, NY 10010, United States of America. Electronic address: keithhaddock@hopehri.com.'}, {'ForeName': 'Elisa V', 'Initials': 'EV', 'LastName': 'Borah', 'Affiliation': 'University of Texas at Austin, Steve Hicks School of Social Work, 1925 San Jacinto Blvd, Austin, TX 78712, United States of America. Electronic address: Elisa.Borah@austin.utexas.edu.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America. Electronic address: Dondanville@uthscsa.edu.'}, {'ForeName': 'Erin P', 'Initials': 'EP', 'LastName': 'Finley', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America; Department of Medicine, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America; Veterans Evidence-based Research Dissemination and Implementation Center (VERDICT), South Texas Veterans Health Care System, 7400 Merton Minter Blvd, San Antonio, TX 78229, United States of America. Electronic address: finleye@uthscsa.edu.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Jahnke', 'Affiliation': 'Social Sciences Innovations Corporation, 71 W 23rd St 4th Floor, New York, NY 10010, United States of America. Electronic address: sara@hopehri.com.'}, {'ForeName': 'Walker S C', 'Initials': 'WSC', 'LastName': 'Poston', 'Affiliation': 'Social Sciences Innovations Corporation, 71 W 23rd St 4th Floor, New York, NY 10010, United States of America. Electronic address: carlosposton@hopehri.com.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Wiltsey-Stirman', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America; Department of Psychiatry and Behavioral Sciences, Stanford University, 401 Quarry Rd, Palo Alto, CA 94305, United States of America. Electronic address: sws1@stanford.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Neitzer', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America. Electronic address: andrea.neitzer@va.gov.'}, {'ForeName': 'Capt Rachel', 'Initials': 'CR', 'LastName': 'Broussard', 'Affiliation': 'David Grant United States Air Force Medical Center, Travis Air Force Base, 101 Bodin Cir, Fairfield, CA, 94533, United States of America. Electronic address: rachel.a.broussard2.mil@mail.mil.'}, {'ForeName': 'Maj Amy', 'Initials': 'MA', 'LastName': 'Brzuchalski', 'Affiliation': 'William Beaumont Army Medical Center, Ft. Bliss, 5005 N Piedras St, El Paso, TX 79920, United States of America. Electronic address: amy.e.brzuchalski.mil@mail.mil.'}, {'ForeName': 'Maj Spencer P', 'Initials': 'MSP', 'LastName': 'Clayton', 'Affiliation': '49th Medical Group, Holloman Air Force Base, 280 1st St, Alamogordo, NM 88330, United States of America. Electronic address: spencer.p.clayton.mil@mail.mil.'}, {'ForeName': 'Lt Allison M', 'Initials': 'LAM', 'LastName': 'Conforte', 'Affiliation': 'Naval Hospital Jacksonville, Naval Air Station Jacksonville, 2080 Child St, Jacksonville, FL 32214, United States of America. Electronic address: allison.m.conforte.mil@mail.mil.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Flores', 'Affiliation': 'William Beaumont Army Medical Center, Ft. Bliss, 5005 N Piedras St, El Paso, TX 79920, United States of America. Electronic address: araceli.flores8.civ@mail.mil.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hein', 'Affiliation': 'Blanchfield Army Community Hospital, Ft. Campbell, 650 Joel Dr, Fort Campbell, KY 42223, United States of America. Electronic address: jessica.l.hein.civ@mail.mil.'}, {'ForeName': 'Capt Felicia', 'Initials': 'CF', 'LastName': 'Keith', 'Affiliation': 'David Grant United States Air Force Medical Center, Travis Air Force Base, 101 Bodin Cir, Fairfield, CA, 94533, United States of America. Electronic address: felicia.a.keith.mil@mail.mil.'}, {'ForeName': 'Capt Jeremy', 'Initials': 'CJ', 'LastName': 'Jinkerson', 'Affiliation': '81st Medical Group, Keesler Air Force Base, 500 Fisher St, Biloxi, MS 39534, United States of America. Electronic address: jeremy.d.jinkerson.mil@mail.mil.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Letendre', 'Affiliation': 'Bassett Army Community Hospital, Ft. Wainwright, 4076 Neely Rd, Fairbanks, AK 99703, United States of America. Electronic address: margaret.a.letendre.civ@mail.mil.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Nofziger', 'Affiliation': 'Brooke Army Medical Center, Joint Base San Antonio-Ft. Sam Houston, 3551 Roger Brooke Dr, San Antonio, TX, 78234, United States of America. Electronic address: debra.l.nofziger.ctr@mail.mil.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Pollick', 'Affiliation': 'Naval Hospital Jacksonville, Naval Air Station Jacksonville, 2080 Child St, Jacksonville, FL 32214, United States of America. Electronic address: kirsten.m.pollick2.civ@mail.mil.'}, {'ForeName': 'Capt Kyra', 'Initials': 'CK', 'LastName': 'Santiago', 'Affiliation': '49th Medical Group, Holloman Air Force Base, 280 1st St, Alamogordo, NM 88330, United States of America. Electronic address: kyra.t.santiago.mil@mail.mil.'}, {'ForeName': 'Lt Col John', 'Initials': 'LCJ', 'LastName': 'Waggoner', 'Affiliation': '81st Medical Group, Keesler Air Force Base, 500 Fisher St, Biloxi, MS 39534, United States of America. Electronic address: john.w.waggoner6.mil@mail.mil.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Woodworth', 'Affiliation': 'Brooke Army Medical Center, Joint Base San Antonio-Ft. Sam Houston, 3551 Roger Brooke Dr, San Antonio, TX, 78234, United States of America. Electronic address: craig.a.woodworth.civ@mail.mil.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America; Department of Psychiatry and Behavioral Sciences, Stanford University, 401 Quarry Rd, Palo Alto, CA 94305, United States of America. Electronic address: carmen.mclean4@va.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106008']
213,32398112,"Modified Sijunzi decoction in the treatment of ulcerative colitis in the remission phase: study protocol for a series of N-of-1 double-blind, randomised controlled trials.","BACKGROUND


Modified Sijunzi decoction (SJZD) has been used to treat ulcerative colitis (UC) in remission. However, more rigorous clinical trials are necessary to evaluate its effectiveness. Therefore, a series of single-case randomised controlled trials (N-of-1 trials) is proposed to compare the efficacy of modified SJZD with mesalazine for treating UC in remission.
METHODS


This is a single-site, hospital-based, double-blind N-of-1 trial for 10 single subjects. Three cycles of N-of-1 trials are planned. There are two treatment periods in each cycle. Modified SJZD combined with mesalazine placebo or mesalazine combined with modified SJZD placebo will be randomised during each 8-week treatment period. There is no washout period in the study. Subjects will be selected by the researcher strictly in accordance with the inclusion and exclusion criteria.
DISCUSSION


Paired t tests and mixed-effect models will be used to analyse the visual analogue scale (VAS) for clinical symptoms and the quality of life questionnaire responses. The findings will be interpreted with caution. We anticipate that the results will show that modified SJZD is effective for patients with UC in remission.
TRIAL REGISTRATION


Chinese Clinical Trial Register, ID: ChiCTR1900024086. Registered on 24 June 2019.",2020,Paired t tests and mixed-effect models will be used to analyse the visual analogue scale (VAS) for clinical symptoms and the quality of life questionnaire responses.,"['10 single subjects', 'patients with UC in remission']","['modified SJZD', 'Modified Sijunzi decoction', 'mesalazine placebo or mesalazine combined with modified SJZD placebo', 'modified SJZD with mesalazine', 'Modified Sijunzi decoction (SJZD']","['visual analogue scale (VAS) for clinical symptoms and the quality of life questionnaire responses', 'ulcerative colitis']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3697010', 'cui_str': 'Ulcerative colitis in remission'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4743423', 'cui_str': 'Sijunzi decoction'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]",10.0,0.586393,Paired t tests and mixed-effect models will be used to analyse the visual analogue scale (VAS) for clinical symptoms and the quality of life questionnaire responses.,"[{'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': 'School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jie-Min', 'Initials': 'JM', 'LastName': 'Deng', 'Affiliation': 'School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': 'The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jiang-Tao', 'Initials': 'JT', 'LastName': 'Hou', 'Affiliation': 'The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Peng', 'Affiliation': 'The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Shi-Jing', 'Initials': 'SJ', 'LastName': 'Zhang', 'Affiliation': 'School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Mi', 'Affiliation': 'The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Qi-Long', 'Initials': 'QL', 'LastName': 'Jiang', 'Affiliation': 'The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xia-Lin', 'Initials': 'XL', 'LastName': 'Wu', 'Affiliation': 'The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Feng-Bin', 'Initials': 'FB', 'LastName': 'Liu', 'Affiliation': 'The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China. liufb163@163.com.'}, {'ForeName': 'Xin-Lin', 'Initials': 'XL', 'LastName': 'Chen', 'Affiliation': 'School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China. chenxlsums@126.com.'}]",Trials,['10.1186/s13063-020-04315-0']
214,32398113,Propranolol for familial cerebral cavernous malformation (Treat_CCM): study protocol for a randomized controlled pilot trial.,"BACKGROUND


Cerebral cavernous malformations (CCMs) are vascular malformations characterized by clusters of enlarged leaky capillaries in the central nervous system. They may result in intracranial haemorrhage, epileptic seizure(s), or focal neurological deficits, and potentially lead to severe disability. Globally, CCMs represent the second most common intracranial vascular malformation in humans, and their familial form (FCCMs) accounts for one-fifth of cases. Neurosurgical excision, and perhaps stereotactic radiosurgery, is the only available therapeutic option. Case reports suggest that propranolol might modify disease progression.
METHODS


Treat_CCM is a prospective, randomized, open-label, blinded endpoint (PROBE), parallel-group trial involving six Italian clinical centres with central reading of brain magnetic resonance imaging (MRI) and adverse events. Patients with symptomatic FCCMs are randomized (2:1 ratio) either to propranolol (40-80 mg twice daily) in addition to standard care or to standard care alone (i.e. anti-epileptic drugs or headache treatments). The primary outcome is intracranial haemorrhage or focal neurological deficit attributable to CCMs. The secondary outcomes are MRI changes over time (i.e. de novo CCM lesions, CCM size and signal characteristics, iron deposition, and vascular leakage as assessed by quantitative susceptibility mapping and dynamic contrast enhanced permeability), disability, health-related quality of life, depression severity, and anxiety (SF-36, BDI-II, State-Trait Anxiety Inventory).
DISCUSSION


Treat_CCM will evaluate the safety and efficacy of propranolol for CCMs following promising case reports in a randomized controlled trial. The direction of effect on the primary outcome and the consistency of effects on the secondary outcomes (even if none of them yield statistically significant differences) of this external pilot study may lead to a larger sample size in a definitive phase 2 trial.
TRIAL REGISTRATION


ClinicalTrails.gov, NCT03589014. Retrospectively registered on 17 July 2018.",2020,The primary outcome is intracranial haemorrhage or focal neurological deficit attributable to CCMs.,"['six Italian clinical centres with central reading of brain magnetic resonance imaging (MRI) and adverse events', 'familial cerebral cavernous malformation (Treat_CCM', 'Retrospectively registered on 17 July 2018', 'Patients with symptomatic FCCMs']","['Propranolol', 'propranolol (40-80\u2009mg twice daily) in addition to standard care or to standard care alone (i.e. anti-epileptic drugs or headache treatments', 'propranolol', 'Neurosurgical excision, and perhaps stereotactic radiosurgery']","['MRI changes over time (i.e. de novo CCM lesions, CCM size and signal characteristics, iron deposition, and vascular leakage as assessed by quantitative susceptibility mapping and dynamic contrast enhanced permeability), disability, health-related quality of life, depression severity, and anxiety (SF-36, BDI-II, State-Trait Anxiety Inventory', 'safety and efficacy', 'intracranial haemorrhage or focal neurological deficit attributable to CCMs']","[{'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2931263', 'cui_str': 'Hereditary cavernous hemangioma of brain'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0085203', 'cui_str': 'Radiosurgery'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0333596', 'cui_str': 'Deposition of iron'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C2919945', 'cui_str': 'Cavernous hemangioma of brain'}]",,0.228911,The primary outcome is intracranial haemorrhage or focal neurological deficit attributable to CCMs.,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Lanfranconi', 'Affiliation': 'Department of Neurology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Padiglione Monteggia-piano 3, Via Francesco Sforza 35, 20122, Milan, Italy. silvia.lanfranconi@policlinico.mi.it.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Scola', 'Affiliation': 'Department of Neuroradiology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122, Milan, Italy.'}, {'ForeName': 'Giulio Andrea', 'Initials': 'GA', 'LastName': 'Bertani', 'Affiliation': 'Department of Neurosurgery, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Zarino', 'Affiliation': 'Department of Neurosurgery, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pallini', 'Affiliation': 'Department of Neurosurgery, Università Cattolica del Sacro Cuore, Largo Francesco Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': ""d'Alessandris"", 'Affiliation': 'Department of Neurosurgery, Università Cattolica del Sacro Cuore, Largo Francesco Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Mazzon', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Contrada Casazza, 98124, Messina, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Marino', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Contrada Casazza, 98124, Messina, Italy.'}, {'ForeName': 'Maria Rita', 'Initials': 'MR', 'LastName': 'Carriero', 'Affiliation': 'Cerebrovascular Disease Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Giovanni Celoria 11, 20133, Milan, Italy.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Scelzo', 'Affiliation': 'Cerebrovascular Disease Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Giovanni Celoria 11, 20133, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Faragò', 'Affiliation': 'Department of Neuroradiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Giovanni Celoria 11, 20133, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Castori', 'Affiliation': 'Division of Medical Genetics, Fondazione IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 2, 71013, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Fusco', 'Affiliation': 'Division of Medical Genetics, Fondazione IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 2, 71013, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Petracca', 'Affiliation': 'Division of Medical Genetics, Fondazione IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 2, 71013, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': ""d'Agruma"", 'Affiliation': 'Division of Medical Genetics, Fondazione IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 2, 71013, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tassi', 'Affiliation': '""Claudio Munari"" Epilepsy Surgery Centre, ASST Grande Ospedale Metropolitano Niguarda, Piazza dell\'Ospedale Maggiore 3, 20162, Milan, Italy.'}, {'ForeName': 'Piergiorgio', 'Initials': 'P', 'LastName': ""d'Orio"", 'Affiliation': '""Claudio Munari"" Epilepsy Surgery Centre, ASST Grande Ospedale Metropolitano Niguarda, Piazza dell\'Ospedale Maggiore 3, 20162, Milan, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Lampugnani', 'Affiliation': 'Laboratory of Vascular Biology, IFOM, Firc Institute for Molecular Oncology, Via Adamello 16, 20139, Milan, Italy.'}, {'ForeName': 'Enrico Bjorn', 'Initials': 'EB', 'LastName': 'Nicolis', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Vasamì', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Novelli', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Laboratory of Research Methodology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Jennifer Marie Theresia Anna', 'Initials': 'JMTA', 'LastName': 'Meessen', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Rustam Al-Shahi', 'Initials': 'RA', 'LastName': 'Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Little France Crescent 49, Edinburgh, EH16 4SB, UK.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Dejana', 'Affiliation': 'Laboratory of Vascular Biology, IFOM, Firc Institute for Molecular Oncology, Via Adamello 16, 20139, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Latini', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-4202-x']
215,32398119,The effect of supplemental oxygen on perioperative brain natriuretic peptide concentration in cardiac risk patients - a protocol for a prosprective randomized clinical trial.,"BACKGROUND


Elevated postoperative N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations are predictive for cardiac adverse events in noncardiac surgery. Studies indicate that supplemental oxygen decreases sympathetic nerve activity and might, therefore, improve cardiovascular function. Thus, we will test the effect of perioperative supplemental oxygen administration on NT-proBNP release after surgery.
METHODS/DESIGN


We will conduct a single-center, double-blinded, randomized trial at the Medical University of Vienna, including 260 patients with increased cardiac risk factors undergoing moderate- to high-risk noncardiac surgery. Patients will be randomly assigned to receive 80% versus 30% oxygen during surgery and for 2 h postoperatively. The primary outcome will be the difference in maximum NT-proBNP release after surgery. As secondary outcomes we will assess the effect of supplemental oxygen on postoperative maximum troponin T concentration, oxidation-reduction potential, von Willebrand factor concentration and perioperative fluid requirements. We will perform outcome measurements 2 h after surgery, on postoperative day 1 and on postoperative day 3. The NT-proBNP concentration and the oxidation-reduction potential will also be measured within 72 h before discharge.
DISCUSSION


Our trial should determine whether perioperative supplemental oxygen administration will reduce the postoperative release of NT-proBNP in patients with preoperative increased cardiovascular risk factors undergoing noncardiac surgery.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03366857. Registered on 8th December 2017.",2020,"BACKGROUND


Elevated postoperative N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations are predictive for cardiac adverse events in noncardiac surgery.","['patients with preoperative increased cardiovascular risk factors undergoing noncardiac surgery', 'noncardiac surgery', '260 patients with increased cardiac risk factors undergoing moderate- to high-risk noncardiac surgery', 'cardiac risk patients']",['supplemental oxygen'],"['NT-proBNP release', 'cardiovascular function', 'maximum NT-proBNP release', 'postoperative maximum troponin T concentration, oxidation-reduction potential, von Willebrand factor concentration and perioperative fluid requirements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]",260.0,0.663905,"BACKGROUND


Elevated postoperative N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations are predictive for cardiac adverse events in noncardiac surgery.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Reiterer', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kabon', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. barbara.kabon@meduniwien.ac.at.'}, {'ForeName': 'Markus Falkner', 'Initials': 'MF', 'LastName': 'von Sonnenburg', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Starlinger', 'Affiliation': 'Department of Surgery, Medical University of Vienna, 1090, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Taschner', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zotti', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Goshin', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Drlicek', 'Affiliation': 'Franziskus Spital, Anaesthesia and Intensive Care, 1050, Vienna, Austria.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}]",Trials,['10.1186/s13063-020-04336-9']
216,32398120,Individualized treatment for acute Achilles tendon rupture based on the Copenhagen Achilles Rupture Treatment Algorithm (CARTA): a study protocol for a multicenter randomized controlled trial.,"BACKGROUND


An individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm (CARTA)) based on the ultrasonographic appearance of an acute Achilles tendon rupture has been developed aiming to select the correct patients for operative and non-operative treatment. The objective of this study is to investigate if this individualized treatment algorithm gives a better functional outcome than treating all patients either operatively or non-operatively per default.
METHODS/DESIGN


This study is conducted as a multicenter, three-armed randomized controlled trial. Participants are included from four hospitals in Denmark and randomized 1:1:1 to one of three parallel groups: 1) Intervention group-participants are treated according to an individualized treatment algorithm; 2) Control group A-participants are treated non-operatively; 3) Control group B-participants are treated operatively. The individualized treatment algorithm for the intervention group is based on an ultrasonographic examination; tendon overlap and elongation below 7% is to be treated non-operatively, while no tendon overlap and/or elongation above 7% will be treated operatively. Over a period of 3 years, 300 participants will be included. The primary outcome is the heel-rise work test at 12 months post-injury. Secondary outcomes are tendon elongation, the Achilles tendon Total Rupture Score (ATRS), the rate of re-ruptures, and other complications. The primary analysis will be conducted as an intention-to-treat analysis.
DISCUSSION


This trial will indicate if treatment of acute Achilles tendon rupture can be individualized based on elongation and tendon overlap. It is hypothesized that different patients will benefit from different treatments instead of offering all the same treatment.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03525964. Registered 16 May 2018.",2020,"BACKGROUND


An individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm (CARTA)) based on the ultrasonographic appearance of an acute Achilles tendon rupture has been developed aiming to select the correct patients for operative and non-operative treatment.","['patients either operatively or non-operatively per default', '300 participants will be included', 'Participants are included from four hospitals in Denmark']","['Copenhagen Achilles Rupture Treatment Algorithm (CARTA', 'Individualized treatment', 'Intervention group-participants are treated according to an individualized treatment algorithm; 2) Control group A-participants are treated non-operatively; 3) Control group B-participants are treated operatively', 'individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm (CARTA']","['heel-rise work test at 12\u2009months post-injury', 'tendon elongation, the Achilles tendon Total Rupture Score (ATRS), the rate of re-ruptures, and other complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0856439', 'cui_str': 'Tendon elongation'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",300.0,0.144609,"BACKGROUND


An individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm (CARTA)) based on the ultrasonographic appearance of an acute Achilles tendon rupture has been developed aiming to select the correct patients for operative and non-operative treatment.","[{'ForeName': 'Maria Swennergren', 'Initials': 'MS', 'LastName': 'Hansen', 'Affiliation': 'Physical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy, Copenhagen University Hospital, Kettegård Alle 30, 2650, Amager-Hvidovre, Denmark. maria_swennergren@hotmail.com.'}, {'ForeName': 'Marianne Toft', 'Initials': 'MT', 'LastName': 'Vestermark', 'Affiliation': 'Department of Orthopedic Surgery, Viborg Regional Hospital, Heiberbs Allé 4, 8800, Viborg, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hölmich', 'Affiliation': 'Sports Orthopedic Research Center - Copenhagen (SORC-C), Department of Orthopedic Surgery, Copenhagen University Hospital, Kettegård Alle 30, 2650, Amager-Hvidovre, Denmark.'}, {'ForeName': 'Morten Tange', 'Initials': 'MT', 'LastName': 'Kristensen', 'Affiliation': 'Physical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy, Copenhagen University Hospital, Kettegård Alle 30, 2650, Amager-Hvidovre, Denmark.'}, {'ForeName': 'Kristoffer Weisskirchner', 'Initials': 'KW', 'LastName': 'Barfod', 'Affiliation': 'Sports Orthopedic Research Center - Copenhagen (SORC-C), Department of Orthopedic Surgery, Copenhagen University Hospital, Kettegård Alle 30, 2650, Amager-Hvidovre, Denmark.'}]",Trials,['10.1186/s13063-020-04332-z']
217,32393214,The transtheoretical model is an effective weight management intervention: a randomized controlled trial.,"BACKGROUND


Given the current worldwide epidemic of obesity, there is a demand for interventions with higher impact, such as those carried out in the primary health care (PHC) setting. Here we evaluate the effect of intervention performed according to the stages of change of the transtheoretical model (TTM) for weight management.
METHODS


This randomized controlled trial in Brazilian PHC offered free physical exercise and nutrition education. The participants were women, aged 20 years or older who were obese or overweight, users in PHC service. The intervention group (IG, n = 51) received the same orientation as the comparison group (CG, n = 35) plus individual health counseling based on the TTM aimed at weight loss, which lasted 6 months. The outcome measures were anthropometric, food, and nutrient profiles. Inflammatory parameters were evaluated in a random subsample. The inter-group and intra-group differences were evaluated using interntion-to-treat analysis, and analysis of covariance (ANCOVA) used to assess intervention effectiveness.
RESULTS


There was a difference between groups of - 1.4 kg (CI95%: - 2.5; - 0.3) in body weight after the intervention. About 97% of women in the IG reported benefits of the intervention and presented positive changes in diet, biochemical markers, and anthropometry. The IG showed better body mass index, resistine, and blood glucose results compared to the CG during follow-up.
CONCLUSION


The individualized TTM-based intervention, combined with usual care, was an effective strategy in PHC. These results should encourage the use of interdisciplinary practices; nevertheless, research to identify additional strategies is needed to address barriers to weight maintenance among obese low-income women.
TRIAL REGISTRATION


The trial is registered with Brazilian clinical trials under the code: RBR-8t7ssv, Registration date: 12/12/2017 (retrospectively registered).",2020,"The IG showed better body mass index, resistine, and blood glucose results compared to the CG during follow-up.
","['participants were women, aged 20\u2009years or older who were obese or overweight, users\xa0in PHC service', 'obese low-income women']","['same orientation as the comparison group (CG, n\u2009=\u200935) plus individual health counseling based on the TTM', 'physical exercise and nutrition education']","['anthropometric, food, and nutrient profiles', 'body weight', 'body mass index, resistine, and blood glucose results']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose level - finding'}]",,0.0888361,"The IG showed better body mass index, resistine, and blood glucose results compared to the CG during follow-up.
","[{'ForeName': 'Patrícia Pinheiro', 'Initials': 'PP', 'LastName': 'de Freitas', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Mariana Carvalho', 'Initials': 'MC', 'LastName': 'de Menezes', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Luana Caroline', 'Initials': 'LC', 'LastName': 'Dos Santos', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Adriano Marçal', 'Initials': 'AM', 'LastName': 'Pimenta', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Adaliene Versiani Matos', 'Initials': 'AVM', 'LastName': 'Ferreira', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Aline Cristine Souza', 'Initials': 'ACS', 'LastName': 'Lopes', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil. alinelopesenf@gmail.com.'}]",BMC public health,['10.1186/s12889-020-08796-1']
218,32393215,"Efficacy of revefenacin, a long-acting muscarinic antagonist for nebulized therapy, in patients with markers of more severe COPD: a post hoc subgroup analysis.","BACKGROUND


Revefenacin, a once-daily, long-acting muscarinic antagonist delivered via standard jet nebulizer, increased trough forced expiratory volume in 1 s (FEV 1 ) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in prior phase 3 trials. We evaluated the efficacy of revefenacin in patients with markers of more severe COPD.
METHODS


A post hoc subgroup analysis of two replicate, randomized, phase 3 trials was conducted over 12 weeks. Endpoints included least squares change from baseline in trough FEV 1 , St. George's Respiratory Questionnaire (SGRQ) responders, and transition dyspnea index (TDI) responders at Day 85. This analysis included patient subgroups at high risk for COPD exacerbations and compared patients who received revefenacin 175 μg and placebo: severe and very severe airflow limitation (percent predicted FEV 1  30%-< 50% and < 30%), 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) D, reversibility (≥ 12% and ≥ 200 mL increase in FEV 1 ) to short-acting bronchodilators, concurrent use of long-acting β agonists and/or inhaled corticosteroids, older age (> 65 and > 75 years), and comorbidity risk factors.
RESULTS


Revefenacin demonstrated significant improvements in FEV 1  versus placebo at Day 85 among the intention-to-treat (ITT) population and all subgroups. Additionally, there was a greater number of SGRQ and TDI responders in the ITT population and the majority of subgroups analyzed among patients who received revefenacin versus placebo. For the SGRQ responders, the odds of response (odds ratio > 2.0) were significantly greater in the revefenacin arm versus the placebo arm among the severe airflow obstruction, very severe airflow obstruction and 2011 GOLD D subgroups. For the TDI responders, the odds of response (odds ratio > 2.0) were significantly greater among the severe airflow obstruction subgroup and patients aged > 75 years.
CONCLUSIONS


Revefenacin showed significantly greater improvements in FEV 1  versus placebo in the ITT population and all subgroups. Furthermore, there were a greater number of SGRQ and TDI responders in the ITT population, and in the majority of patient subgroups among patients who received revefenacin versus placebo. Based on the data presented, revefenacin could be a therapeutic option among patients with markers of more severe COPD.
TRIAL REGISTRATION


Clinical trials registered with www.clinicaltrials.gov (Studies 0126 [NCT02459080; prospectively registered 22 May 2015] and 0127 [NCT02512510; prospectively registered 28 July 2015]).",2020,"For the SGRQ responders, the odds of response (odds ratio > 2.0) were significantly greater in the revefenacin arm versus the placebo arm among the severe airflow obstruction, very severe airflow obstruction and 2011 GOLD D subgroups.","['www.clinicaltrials.gov (Studies 0126 [NCT02459080; prospectively registered 22 May 2015] and 0127', 'patients with markers of more severe COPD', 'patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in prior phase 3 trials', 'patient subgroups at high risk for COPD exacerbations and compared patients who received', 'and/or inhaled corticosteroids, older age (>\u200965 and\u2009>\u200975\u2009years), and comorbidity risk factors']","['revefenacin', 'revefenacin versus placebo', 'revefenacin 175\u2009μg and placebo', 'placebo']","['FEV', 'number of SGRQ and TDI responders', ""least squares change from baseline in trough FEV 1 , St. George's Respiratory Questionnaire (SGRQ) responders, and transition dyspnea index (TDI) responders"", 'severe airflow limitation', '2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) D, reversibility ']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C4519232', 'cui_str': 'revefenacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0449261', 'cui_str': 'Reversibility'}]",,0.403189,"For the SGRQ responders, the odds of response (odds ratio > 2.0) were significantly greater in the revefenacin arm versus the placebo arm among the severe airflow obstruction, very severe airflow obstruction and 2011 GOLD D subgroups.","[{'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Donohue', 'Affiliation': 'Pulmonary Medicine, UNC School of Medicine, 321 S Columbia St, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, LLC, 3860 Crater Lake Ave, Medford, OR, 97504, USA.'}, {'ForeName': 'Chris N', 'Initials': 'CN', 'LastName': 'Barnes', 'Affiliation': 'Theravance Biopharma US, Inc., 901 Gateway Blvd, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Edmund J', 'Initials': 'EJ', 'LastName': 'Moran', 'Affiliation': 'Theravance Biopharma US, Inc., 901 Gateway Blvd, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Haumann', 'Affiliation': 'Theravance Biopharma US, Inc., 901 Gateway Blvd, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Glenn D', 'Initials': 'GD', 'LastName': 'Crater', 'Affiliation': 'Theravance Biopharma US, Inc., 901 Gateway Blvd, South San Francisco, CA, 94080, USA. gcrater@theravance.com.'}]",BMC pulmonary medicine,['10.1186/s12890-020-1156-4']
219,32393559,Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial.,"PURPOSE


To test the efficacy of intra-articular hypertonic dextrose prolotherapy (DPT) vs normal saline (NS) injection for knee osteoarthritis (KOA).
METHODS


A single-center, parallel-group, blinded, randomized controlled trial was conducted at a university primary care clinic in Hong Kong. Patients with KOA (n = 76) were randomly allocated (1:1) to DPT or NS groups for injections at weeks 0, 4, 8, and 16. The primary outcome was the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 0-100 points) pain score. The secondary outcomes were the WOMAC composite, function and stiffness scores; objectively assessed physical function test results; visual analogue scale (VAS) for knee pain; and EuroQol-5D score. All outcomes were evaluated at baseline and at 16, 26, and 52 weeks using linear mixed model.
RESULTS


Randomization produced similar groups. The WOMAC pain score at 52 weeks showed a difference-in-difference estimate of -10.34 (95% CI, -19.20 to -1.49,  P  = 0.022) points. A similar favorable effect was shown on the difference-in-difference estimate on WOMAC function score of -9.55 (95% CI, -17.72 to -1.39,  P  = 0.022), WOMAC composite score of -9.65 (95% CI, -17.77 to -1.53,  P  = 0.020), VAS pain intensity score of -10.98 (95% CI, -21.36 to -0.61,  P  = 0.038), and EuroQol-5D VAS score of 8.64 (95% CI, 1.36 to 5.92,  P  = 0.020). No adverse events were reported.
CONCLUSION


Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections. The procedure is straightforward and safe; the adherence and satisfaction were high.",2020,"CONCLUSION


Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections.","['Patients with KOA (n = 76', 'Knee Osteoarthritis', 'university primary care clinic in Hong Kong', 'patients with KOA', 'knee osteoarthritis (KOA']","['DPT or NS', 'Intra-Articular Hypertonic Dextrose (Prolotherapy', 'intra-articular hypertonic dextrose prolotherapy (DPT) vs normal saline (NS) injection']","['EuroQol-5D VAS score', 'WOMAC composite score', 'WOMAC function score', 'pain, improved function and quality of life', 'Western Ontario McMaster University Osteoarthritis Index (WOMAC; 0-100 points) pain score', 'WOMAC composite, function and stiffness scores; objectively assessed physical function test results; visual analogue scale (VAS) for knee pain; and EuroQol-5D score', 'adverse events', 'WOMAC pain score', 'VAS pain intensity score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",76.0,0.385251,"CONCLUSION


Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections.","[{'ForeName': 'Regina Wing Shan', 'Initials': 'RWS', 'LastName': 'Sit', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong reginasit@cuhk.edu.hk.'}, {'ForeName': 'Ricky Wing Keung', 'Initials': 'RWK', 'LastName': 'Wu', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rabago', 'Affiliation': 'Department of Family Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Kenneth Dean', 'Initials': 'KD', 'LastName': 'Reeves', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Dicken Cheong Chun', 'Initials': 'DCC', 'LastName': 'Chan', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Benjamin Hon Kei', 'Initials': 'BHK', 'LastName': 'Yip', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Vincent Chi Ho', 'Initials': 'VCH', 'LastName': 'Chung', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Samuel Yeung Shan', 'Initials': 'SYS', 'LastName': 'Wong', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}]",Annals of family medicine,['10.1370/afm.2520']
220,32396257,"Ropinirole Patch Versus Placebo, Ropinirole Extended-Release Tablet in Advanced Parkinson's Disease.","BACKGROUND


A dopamine agonist patch is an important treatment option for PD.
OBJECTIVES


A randomized, double-blind, parallel-group, placebo-controlled trial was conducted to evaluate superiority of ropinirole hydrochloride patch over placebo and noninferiority to ropinirole hydrochloride extended-release tablet.
METHODS


PD patients using levodopa received ropinirole patch (up to 64 mg/d), ropinirole tablets (up to 16 mg/d), or placebo once-daily (double-dummy technique). The primary endpoint was the change from baseline in the total score for the UPDRS Part III (on state) at week 16.
RESULTS


The change of the least squares mean (95% confidence interval) in the UPDRS Part III total score was -9.8 (-10.8 to -8.7) with ropinirole patch, -4.3 (-5.8 to -2.8) with placebo, and -10.1 (-11.2 to -9.1) with ropinirole tablet. The difference between the ropinirole patch and placebo groups was -5.4 (-7.3 to -3.6), demonstrating superiority of the patch over placebo. The difference between the ropinirole patch and tablet groups was 0.3 (-1.2 to 1.8). The upper limit of the 95% confidence interval was smaller than the noninferiority limit of 2.5, demonstrating noninferiority of ropinirole patch to ropinirole tablet. In all three groups, most adverse events were mild or moderate and there were no serious safety concerns.
CONCLUSIONS


Once-daily ropinirole patch was effective in advanced PD patients, having demonstrated superiority over placebo and noninferiority to ropinirole tablet, without causing serious safety problems. Ropinirole patch can be an alternative option for PD patients. © 2020 International Parkinson and Movement Disorder Society.",2020,"The upper limit of the 95% confidence interval was smaller than the noninferiority limit of 2.5, demonstrating noninferiority of ropinirole patch to ropinirole tablet.","['advanced PD patients', 'PD patients', ""Advanced Parkinson's Disease"", 'PD patients using']","['dopamine agonist patch', 'Ropinirole patch', 'ropinirole tablet', 'ropinirole tablets', 'ropinirole patch', 'levodopa received ropinirole patch', 'ropinirole hydrochloride', 'ropinirole hydrochloride patch over placebo', 'Ropinirole Patch Versus Placebo, Ropinirole Extended-Release Tablet', 'ropinirole patch and placebo', 'placebo']","['UPDRS Part III total score', 'total score for the UPDRS Part III (on state']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0244821', 'cui_str': 'ropinirole'}, {'cui': 'C1247870', 'cui_str': 'ropinirole Oral Tablet'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0771840', 'cui_str': 'Ropinirole hydrochloride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2344623', 'cui_str': 'ropinirole Extended Release Oral Tablet'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.637977,"The upper limit of the 95% confidence interval was smaller than the noninferiority limit of 2.5, demonstrating noninferiority of ropinirole patch to ropinirole tablet.","[{'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Neurology, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Neurology, Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University Hospital, Ehime, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Uchida', 'Affiliation': 'Office for Promoting Medical Research, Showa University, Tokyo, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Terahara', 'Affiliation': 'Hisamitsu Pharmaceutical Co., Inc., Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Okawa', 'Affiliation': 'Hisamitsu Pharmaceutical Co., Inc., Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fukuta', 'Affiliation': 'Hisamitsu Pharmaceutical Co., Inc., Tokyo, Japan.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28071']
221,32398130,Evaluation of a communication skills training to facilitate addressing palliative care related topics in advanced cancer patients: study protocol of a multicenter randomized controlled trial (PALLI-KOM).,"BACKGROUND


Early integration of palliative care concurrently to standard cancer care is associated with several benefits for patients and their caregivers. However, communication barriers on part of the caring physicians often impede a timely referral to palliative care. This study describes the protocol of the evaluation of a communication skills training aiming to strengthen the ability of physicians to address palliative care related topics adequately and early during disease trajectory.
METHODS


We will implement a communication skills training and evaluate it within a prospective, multi-centered, two-armed randomized controlled trial (RCT), which will be conducted at four sites in Germany. Eligible subjects are all physicians treating patients with advanced cancer in their daily routine. An intervention group (IG) receiving a group training will be compared to a wait-list control group (CG) receiving the training after completion of data collection. At pre- and post-measurement points, participants will conduct videotaped conversations with standardized simulated patients (SP). Primary outcome will be the external rating of communication skills and consulting competencies addressing palliative care related topics. Secondary outcomes on core concepts of palliative care, basic knowledge, attitudes, confidence and self-efficacy will be assessed by standardized questionnaires and self-developed items. A further external assessment of the quality of physician-patient-interaction will be conducted by the SP. Longitudinal quantitative data will be analyzed using covariate-adjusted linear mixed-models.
DISCUSSION


If the communication skills training proves to be effective, it will provide a feasible intervention to promote an earlier communication of palliative care related topics in the care of advanced cancer patients. This would help to further establish early integration of palliative care as it is recommended by national and international guidelines.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00017025 (date of registration: 4 June 2019).",2020,An intervention group (IG) receiving a group training will be compared to a wait-list control group (CG) receiving the training after completion of data collection.,"['advanced cancer patients', 'patients and their caregivers', 'Eligible subjects are all physicians treating patients with advanced cancer in their daily routine']",['communication skills training'],"['core concepts of palliative care, basic knowledge, attitudes, confidence and self-efficacy will be assessed by standardized questionnaires and self-developed items', 'external rating of communication skills and consulting competencies addressing palliative care related topics']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0588407', 'cui_str': 'Communication skills training'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}]",,0.0914104,An intervention group (IG) receiving a group training will be compared to a wait-list control group (CG) receiving the training after completion of data collection.,"[{'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Harnischfeger', 'Affiliation': 'Department of Oncology, Hematology and BMT, Palliative Care Unit, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. n.harnischfeger@uke.de.'}, {'ForeName': 'Hilke M', 'Initials': 'HM', 'LastName': 'Rath', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'Ullrich', 'Affiliation': 'Department of Oncology, Hematology and BMT, Palliative Care Unit, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Alt-Epping', 'Affiliation': 'Department of Palliative Medicine, University Medical Center Goettingen, Goettingen, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Letsch', 'Affiliation': 'Department of Hematology, Oncology and Tumor Immunology, Campus Kiel, University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thuss-Patience', 'Affiliation': 'Medical Department, Division of Hematology, Oncology and Tumor Immunology, Campus Virchow Clinic, Charite University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'Department of Oncology, Hematology and BMT, Palliative Care Unit, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Oechsle', 'Affiliation': 'Department of Oncology, Hematology and BMT, Palliative Care Unit, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bergelt', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMC palliative care,['10.1186/s12904-020-00568-3']
222,32398149,Normalization of a conversation tool to promote shared decision making about anticoagulation in patients with atrial fibrillation within a practical randomized trial of its effectiveness: a cross-sectional study.,"BACKGROUND


Shared decision making (SDM) implementation remains challenging. The factors that promote or hinder implementation of SDM tools for use during the consultation, including contextual factors such as clinician burnout and organizational support, remain unclear. We explored these factors in the context of a practical multicenter randomized trial evaluating the effectiveness of an SDM conversation tool for patients with atrial fibrillation considering anticoagulation therapy.
METHODS


In this cross-sectional study, we recruited clinicians who were regularly involved in conversations with patients regarding anticoagulation for atrial fibrillation. Clinicians reported their characteristics and burnout symptoms using the two-item Maslach Burnout Inventory. Clinicians were trained in using the SDM tool, and they recorded their perceptions of the tool's normalization potential using the Normalization MeAsure Development (NoMAD) survey instrument and verbally reflected on their answers to these survey questions. When possible, the training sessions and clinicians' verbal responses to the conversation tool were recorded.
RESULTS


Our study comprised 183 clinicians recruited into the trial (168 with survey responses and 112 with recordings). Overall, clinicians gave high scores to the normalization potential of the intervention; they endorsed all domains of normalization to the same extent, regardless of site, clinician characteristics, or burnout ratings. In interviews, clinicians paid significant attention to making sense of the tool. Tool buy-in seemed to depend heavily on their ability to see the tool as accurate and ""evidence-based"" and their perceptions of having time in the consultation to use it.
CONCLUSIONS


While time in the consultation remains a barrier, we did not find a significant association between burnout symptoms and normalization of an SDM conversation tool. Possible areas for improving the normalization of SDM conversation tools in clinical practice include enabling collaboration among clinicians to implement the tool and reporting how clinicians elsewhere use the tool. Direct measures of normalization (i.e., observing how often clinicians access the tool in practice outside of the clinical trial) may further elucidate the role that contextual factors, such as clinician burnout, play in the implementation of SDM.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02905032. Registered on 9 September 2016.",2020,"Tool buy-in seemed to depend heavily on their ability to see the tool as accurate and ""evidence-based"" and their perceptions of having time in the consultation to use it.
","['183 clinicians recruited into the trial (168 with survey responses and 112 with recordings', 'patients with atrial fibrillation considering anticoagulation therapy', 'patients with atrial fibrillation', 'recruited clinicians who were regularly involved in conversations with patients regarding anticoagulation for atrial fibrillation']",['SDM conversation tool'],[],"[{'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0566061', 'cui_str': 'Does make conversation'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",[],183.0,0.0285299,"Tool buy-in seemed to depend heavily on their ability to see the tool as accurate and ""evidence-based"" and their perceptions of having time in the consultation to use it.
","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Spencer-Bonilla', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Thota', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Organick', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Oscar J', 'Initials': 'OJ', 'LastName': 'Ponce', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Kunneman', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Giblon', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Branda', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Sivly', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Behnken', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Carl R', 'Initials': 'CR', 'LastName': 'May', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Montori', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA. montori.victor@mayo.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04305-2']
223,32398160,"Nitrous oxide/oxygen plus acetaminophen versus morphine in ST elevation myocardial infarction: open-label, cluster-randomized, non-inferiority study.","BACKGROUND


Studies have shown disparate results on the consequences of morphine use in ST-segment elevation myocardial infarction (STEMI). No study has evaluated alternative treatments that could be at least non-inferior to morphine without its potentially damaging consequences for myocardial function and platelet reactivity. The aim of this study was to evaluate whether nitrous oxide/oxygen plus intravenous acetaminophen (NOO-A) is non-inferior to morphine to control chest pain in STEMI patients.
METHODS


This multicenter, open-label, cluster-randomized, controlled, non-inferiority study compared NOO-A with morphine in 684 prehospital patients with ongoing suspected STEMI of < 12 h duration and a pain rating score ≥ 4. The primary endpoint was the proportion of patients achieving pain relief (numeric rating score ≤ 3) after 30 min. Secondary safety endpoints included serious adverse events and death at 30 days.
RESULTS


The median baseline pain score was 7.0 in both groups. The primary endpoint occurred in 51.7% of the NOO-A group and 73.6% of the morphine group (absolute risk difference - 21.7%; 95% confidence interval - 29.6 to - 13.8). At 30 days, the rate of serious adverse events was 16.0 and 18.8% in the NOO-A and morphine groups respectively (p = NS). The rate of death was 1.8% (NOO-A group) and 3.8% (morphine group) (p = NS).
CONCLUSION


Analgesia provided by NOO-A was inferior to morphine at 30 min in patients with acute STEMI in the prehospital setting. Rates of serious adverse events did not differ between groups.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02198378.",2020,Analgesia provided by NOO-A was inferior to morphine at 30 min in patients with acute STEMI in the prehospital setting.,"['684 prehospital patients with ongoing suspected STEMI of <\u200912\u2009h duration and a pain rating score\u2009≥\u20094', 'STEMI patients', 'ST elevation myocardial infarction']","['nitrous oxide/oxygen plus intravenous acetaminophen (NOO-A', 'NOO-A with morphine', 'Nitrous oxide/oxygen plus acetaminophen', 'morphine']","['rate of death', 'proportion of patients achieving pain relief (numeric rating score', 'median baseline pain score', 'serious adverse events and death at 30\u2009days', 'rate of serious adverse events', 'Rates of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]","[{'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",684.0,0.243387,Analgesia provided by NOO-A was inferior to morphine at 30 min in patients with acute STEMI in the prehospital setting.,"[{'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Charpentier', 'Affiliation': 'Emergency Department, Toulouse University Hospital, INSERM UMR 1027, University Toulouse III Paul Sabatier, Toulouse, France. charpentier.s@chu-toulouse.fr.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Galinski', 'Affiliation': 'Emergency Department - SAMU 33, CHU de Bordeaux; INSERM U1219 - Injury Epidemiology Transport Occupation"" team, University Bordeaux II, 33000, Bordeaux, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Bounes', 'Affiliation': 'SAMU31, Toulouse University Hospital; University Toulouse III Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Ricard-Hibon', 'Affiliation': 'Pôle Emergency Department, SAMU - Centre Hospitalier René Dubos Pontoise, 95300, Pontoise, France.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'El-Khoury', 'Affiliation': 'Emergency Department and RESCUe Network, Lucien Hussel Hospital, Vienne, France.'}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Elbaz', 'Affiliation': 'Department of Cardiology, Rangueil University Hospital, Toulouse, France.'}, {'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Ageron', 'Affiliation': 'Emergency Department, Centre Hospitalier Annecy Genevois, Annecy, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Manzo-Silberman', 'Affiliation': 'Cardiology department, Lariboisire Hospital, APHP, Paris, France.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Soulat', 'Affiliation': 'SAMU 35 SMUR Urgences adultes, Centre Hospitalier Universitaire Rennes, Université Rennes 1, Rennes, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Lapostolle', 'Affiliation': 'SAMU 93 - UF Recherche-Enseignement-Qualité Université Paris 13, Sorbonne Paris Cité, Inserm U942 Hôpital Avicenne, AP-HP, 125, rue de Stalingrad, 93009, Bobigny, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gérard', 'Affiliation': ""Hospices Civils de Lyon SAMU 69 - Hôpital Édouard HERRIOT 5, place d'Arsonval, 69437, LYON Cedex 03, France.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Bregeaud', 'Affiliation': 'Hospital Centre of Chateauroux, Chateauroux, France.'}, {'ForeName': 'Vanina', 'Initials': 'V', 'LastName': 'Bongard', 'Affiliation': 'Department of Epidemiology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bonnefoy-Cudraz', 'Affiliation': 'Hôpital cardiologique Louis-Pradel, 69500, Lyon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Scandinavian journal of trauma, resuscitation and emergency medicine",['10.1186/s13049-020-00731-y']
224,32334332,The effects of consecutive sessions of anodal transcranial direct current stimulation over the primary motor cortex on hand function in healthy older adults.,"BACKGROUND


With advancing age, changes in the central nervous system may lead to motor functional deficits. Non-invasive brain stimulation techniques are suggested to help modifying brain function.
OBJECTIVES


The aim of the current study was to investigate the effect of using multi session anodal transcranial Direct Current Stimulation (a-tDCS) over the primary motor cortex (M1) on the hand function in healthy older adults.
METHOD


In this randomized, double-blinded, sham-controlled study 32 participants received active or sham a-tDCS (1 mA, 20 min, for five consecutive days) and performed the Purdue Pegboard Test (PPT) on the first day before tDCS application, immediately (T1), 30 min (T2), and one week after the last session (5th day) (T3) of the stimulation.
RESULTS


There was a significant improvement for PPT (p < 0.05) in a-tDCS group at all post-test values except for PPT for left hand (PPTL) at T1. Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
CONCLUSION


The current findings suggest a-tDCS can be considered as a promising stand-alone technique in the intervention of the age-related decline of manual dexterity for improving hand function.",2020,"Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
","['32 participants received', 'healthy older adults']","['multi session anodal transcranial Direct Current Stimulation (a-tDCS', 'active or sham a-tDCS', 'anodal transcranial direct current stimulation']","['PPT', 'PPT subtests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0204462', 'cui_str': 'Purdue pegboard test'}]",32.0,0.0611213,"Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Rostami', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. Electronic address: zmosallanezhad@yahoo.com.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Speech Therapy Department, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Dawson', 'Initials': 'D', 'LastName': 'Kidgell', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Tahere', 'Initials': 'T', 'LastName': 'Rezaeian', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Enayatollah', 'Initials': 'E', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghodrati', 'Affiliation': 'Health and Rehabilitation Sciences Program, University of Western Ontario, London, Canada.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104063']
225,32335343,"Safety and efficacy of memantine for multiple sclerosis-related fatigue: A pilot randomized, double-blind placebo-controlled trial.","BACKGROUND


Fatigue is one of the most common symptoms in patients with multiple sclerosis (MS). Currently, there is no approved medication for MS-related fatigue.
OBJECTIVE


In this study, we aim to evaluate the safety and efficacy of memantine for improving fatigue in patients with MS.
METHODS


This was a pilot randomized, double-blind, placebo-controlled clinical trial. Eligible patients with relapsing-remitting MS (RRMS) according to the McDonald criteria were randomized to receive either memantine (20 mg/day) or placebo and were assessed at baseline and three months after treatment. The change in the severity of fatigue was determined by the Modified Fatigue Impact Scale (MFIS).
RESULTS


Sixty-four patients were randomly allocated to the memantine (n = 32) and placebo (n = 32) groups. Sixteen patients in the memantine group and 24 patients in the placebo group completed the study. The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702). No serious adverse events were reported, except for dizziness and sedation in four patients in the experimental arm, which resulted in discontinuation.
CONCLUSION


This trial failed to prove any clinical efficacy of memantine for the management of MS-related fatigue. Although memantine was generally well-tolerated, adverse events were among the major causes of dropout in this study.",2020,"The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702).","['multiple sclerosis-related fatigue', 'Sixteen patients in the memantine group and 24 patients in the', 'patients with MS', 'Sixty-four patients', 'patients with multiple sclerosis (MS', 'Eligible patients with relapsing-remitting MS (RRMS) according to the McDonald criteria']","['placebo', 'memantine']","['MFIS scores', 'tolerated, adverse events', 'Safety and efficacy', 'serious adverse events', 'safety and efficacy', 'severity of fatigue', 'dizziness and sedation', 'Modified Fatigue Impact Scale (MFIS']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960438', 'cui_str': 'Fatigue impact scale score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}]",64.0,0.542728,"The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702).","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Falsafi', 'Affiliation': 'Department of Neurology, Alavi Hospital, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Tafakhori', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Agah', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mojarrad', 'Affiliation': 'School of medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reihaneh', 'Initials': 'R', 'LastName': 'Dehghani', 'Affiliation': 'Molecular Immunology Research Center, School of Medicine, Tehran University of Medical Science, Tehran 1419783151, Iran; Network of Immunity in Infection, Malignancy, and Autoimmunity (NIIMA), Universal Scientific Education and Research Network (USERN), Los Angeles, CA 90001, USA.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghaffarpour', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: ghafarpour@tums.ac.ir.'}, {'ForeName': 'Vajiheh', 'Initials': 'V', 'LastName': 'Aghamollaii', 'Affiliation': 'Department of Neurology, Roozbeh Hospital, Tehran University of Medical Sciences, Roozbeh Hospital, Tehran, Iran.'}, {'ForeName': 'Seyed Vahid', 'Initials': 'SV', 'LastName': 'Mousavi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Fouladi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Pourghaz', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pargol', 'Initials': 'P', 'LastName': 'Balali', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Harirchian', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: harirchm@tums.ac.ir.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116844']
226,32336008,A randomised Phase II trial of carboplatin and gemcitabine ± vandetanib in first-line treatment of patients with advanced urothelial cell cancer not suitable to receive cisplatin.,"OBJECTIVES


To assess the efficacy and tolerability of the dual epidermal growth factor receptor/vascular endothelial growth factor receptor inhibitor, vandetanib, in combination with carboplatin and gemcitabine in the first-line treatment of patients with advanced transitional cell carcinoma urothelial cancer (UC) who were unsuitable for cisplatin.
PATIENTS AND METHODS


From 2011 to 2014, 82 patients were randomised from 16 hospitals across the UK into the TOUCAN double-blind, placebo-controlled randomised Phase II trial, receiving six 21-day cycles of intravenous carboplatin (target area under the concentration versus time curve 4.5, day 1) and gemcitabine (1000 mg/m 2  days 1 and 8) combined with either oral vandetanib 100 mg or placebo (once daily). Progression-free survival (PFS; primary endpoint), adverse events, tolerability and feasibility of use, objective response rate and overall survival (OS) were evaluated. Intention-to-treat and per-protocol analyses were used to analyse the primary endpoint.
RESULTS


The 82 patients were randomised 1:1 to vandetanib (n = 40) or placebo (n = 42), and 25 patients (30%) completed six cycles of all allocated treatment. Toxicity Grade ≥3 was experienced in 80% (n = 32) and 76% (n = 32) of patients in the vandetanib and placebo arms, respectively. The median PFS was 6.8 and 8.8 months for the vandetanib and placebo arms, respectively (hazard ratio [HR] 1.07, 95% confidence interval [CI] 0.65-1.76; P = 0.71); the median OS was 10.8 vs 13.8 months (HR 1.41, 95% CI 0.79-2.52; P = 0.88); and radiological response rates were 50% and 55%.
CONCLUSION


There is no evidence that vandetanib improves clinical outcome in this setting. Our present data do not support its adoption as the regimen of choice for first-line treatment in patients with UC who were unfit for cisplatin.",2020,Toxicity ≥grade 3 was experienced in 80% (n=32) and 76% (n=32) of patients on vandetanib and placebo arms respectively.,"['UC patients who were unfit for cisplatin', '25 patients (30%) completed 6 cycles of all allocated treatment', 'Eighty-two patients', 'patients with advanced urolthelial cancer (UC) who were unsuitable for cisplatin', 'From 2011 and 2014', 'advanced urothelial cell cancer patients', '82 patients were randomised from 16 hospitals across the UK into the TOUCAN double-blind']","['oral vandetanib 100mg or placebo', 'carboplatin and gemcitabine ', 'dual EGFR/VEGFR inhibitor, vandetanib, in combination with carboplatin and gemcitabine', 'placebo', 'cisplatin', 'vandetanib', 'intravenous carboplatin (AUC 4.5 day 1) and gemcitabine']","['efficacy and tolerability', 'radiological response rates', 'Progression-free survival (PFS - primary endpoint), adverse events (AEs), tolerability and feasibility of use, objective response rate and overall survival (OS', 'Median PFS']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0227599', 'cui_str': 'Urinary tract transitional epithelial cell'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2960054', 'cui_str': 'Ramphastinae'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3152967', 'cui_str': 'Vandetanib 100 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1121849', 'cui_str': 'Vandetanib'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",82.0,0.528557,Toxicity ≥grade 3 was experienced in 80% (n=32) and 76% (n=32) of patients on vandetanib and placebo arms respectively.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Crabb', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chester', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Elliott', 'Affiliation': 'Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Huddart', 'Affiliation': 'Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Royal Lancaster Infirmary, Lancaster, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Evans', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lester', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Satinder', 'Initials': 'S', 'LastName': 'Jagdev', 'Affiliation': ""St. James's University Hospital, Leeds, UK.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Casbard', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Tracie-Ann', 'Initials': 'TA', 'LastName': 'Madden', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}]",BJU international,['10.1111/bju.15096']
227,32272256,"No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.","The SWEDEGRAFT study (ClinicalTrials.gov Identifier: NCT03501303) tests the hypothesis that saphenous vein grafts (SVGs) harvested with the ""no-touch"" technique improves patency of coronary artery bypass grafts compared with the conventional open skeletonized technique. This article describes the rationale and design of the randomized trial and baseline characteristics of the population enrolled during the first 9 months of enrollment. The SWEDEGRAFT study is a prospective, binational multicenter, open-label, registry-based trial in patients undergoing first isolated nonemergent coronary artery bypass grafting (CABG), randomized 1:1 to no-touch or conventional open skeletonized vein harvesting technique, with a planned enrollment of 900 patients. The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years. High-quality health registries and coronary computed tomography angiography are used to assess the primary end point. The secondary end points include wound healing in the vein graft sites and the composite outcome of major adverse cardiac events during the first 2 years based on registry data. Demographics of the first 200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration. RCT# NCT03501303.",2020,"The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years.","['200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration', 'patients undergoing first isolated']","['saphenous vein grafts', 'coronary computed tomography angiography', 'nonemergent coronary artery bypass grafting (CABG', 'saphenous vein grafts (SVGs) harvested with the ""no-touch"" technique', 'no-touch or conventional open skeletonized vein harvesting technique', 'coronary artery surgery (SWEDEGRAFT']","['patency of coronary artery bypass grafts', 'wound healing in the vein graft sites and the composite outcome of major adverse cardiac events', 'proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}]","[{'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0398206', 'cui_str': 'Harvesting of vein'}, {'cui': 'C0190188', 'cui_str': 'Operative procedure on coronary artery'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0333181', 'cui_str': 'Stenosed'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]",200.0,0.0320323,"The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years.","[{'ForeName': 'Sigurdur', 'Initials': 'S', 'LastName': 'Ragnarsson', 'Affiliation': 'Skane University Hospital and Lund University, Lund, Sweden. Electronic address: sigurdur.ragnarsson@med.lu.se.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Janiec', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Ivy Susanne', 'Initials': 'IS', 'LastName': 'Modrau', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Dreifaldt', 'Affiliation': 'Orebro University Hospital, Orebro, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ericsson', 'Affiliation': 'Blekinge Hospital, Karlskrona, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Holmgren', 'Affiliation': 'University Hospital of Umea, Umea, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hultkvist', 'Affiliation': 'Linkoping University Hospital, Linkoping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Jeppsson', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Sartipy', 'Affiliation': 'Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ternström', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Per Vikholm', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Domingos', 'Initials': 'D', 'LastName': 'de Souza', 'Affiliation': 'Orebro University Hospital, Orebro, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Thelin', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}]",American heart journal,['10.1016/j.ahj.2020.03.009']
228,32278195,Cardiorespiratory responses to fine particles during ambient PM 2.5  pollution waves: Findings from a randomized crossover trial in young healthy adults.,"BACKGROUND


PM 2.5  pollution waves (PPWs) are severe air pollution events with extremely high-level concentration of ambient PM 2.5 . PPWs, such as haze days, were suggested to be associated with increased cardiopulmonary mortality and morbidity. However, the biological mechanism response to ambient PM 2.5  during PPWs is still unclear.
METHODS


A randomized crossover trial was conducted on 29 healthy young adults. Repeated health measurements were performed before, during and after two typical PPWs under filtered and sham indoor air purification, with a washout interval of at least 2 weeks. Health parameters including blood pressure (BP), pulmonary function, fractional exhaled nitric oxide (FeNO) and circulating biomarkers which reflect platelet activation, blood coagulation and systematic oxidative stress were measured.
RESULTS


Ambient PM 2.5  levels elevated apparently during PPWs. Under sham purification, significant increase in FeNO and soluble P-selectin (sP-selectin) and decreases in pulmonary function were observed from pre-PPWs period to during-PPWs period. The changes in health biomarkers as mentioned above became attenuated and insignificant under filtered condition. For instance, sP-selectin increased by 12.0% (95% CI: 3.8%, 20.8%) during-PPWs periods compared with pre-PPWs periods under sham purification, while non-significant change was observed under filtered condition. Significant associations between time-weighted personal PM 2.5  exposure and increased levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α) were found.
CONCLUSION


PPWs could affect cardiopulmonary health through systematic oxidative stress, platelet activation and respiratory inflammation in healthy adults, and short-term indoor air purification could alleviate the adverse cardiopulmonary effects.",2020,"Significant associations between time-weighted personal PM 2.5  exposure and increased levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α) were found.
","['healthy adults', 'young healthy adults', '29 healthy young adults']",[],"['blood pressure (BP), pulmonary function, fractional exhaled nitric oxide (FeNO) and circulating biomarkers which reflect platelet activation, blood coagulation and systematic oxidative stress', 'levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α', 'FeNO and soluble P-selectin (sP-selectin', 'cardiopulmonary mortality and morbidity', 'health biomarkers', 'Cardiorespiratory responses', 'sP-selectin', 'pulmonary function']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282651', 'cui_str': 'Selectins'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",29.0,0.0335382,"Significant associations between time-weighted personal PM 2.5  exposure and increased levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α) were found.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Minghao', 'Initials': 'M', 'LastName': 'Kou', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Zemin', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Shaowei', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China. Electronic address: jing_huang@bjmu.edu.cn.'}, {'ForeName': 'Xinbiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China. Electronic address: guoxb@bjmu.edu.cn.'}]",Environment international,['10.1016/j.envint.2020.105590']
229,32302930,"Attentional prioritization in dual-task walking: Effects of stroke, environment, and instructed focus.","BACKGROUND


The impact of high distraction, real-world environments on dual-task interference and flexibility of attentional prioritization during dual-task walking in people with stroke is unknown.
RESEARCH QUESTION


How does a real-world environment affect dual-task performance and flexible task prioritization during dual-task walking in adults with and without stroke?
METHODS


Adults with stroke (n = 29) as well as age-, gender-, and education-matched adults without stroke (n = 23) participated. Single and dual-task walking were examined in two different environments (lab hallway, hospital lobby). Two different dual-task combinations were assessed (Stroop-gait, speech-gait). Each dual-task was performed first without explicit instruction about task prioritization (no-priority) and then with gait-priority instruction and Stroop/speech-priority instruction in randomized order.
RESULTS


People with stroke had significantly slower dual-task gait speed (Stroop only) in the lobby than the lab, but the effect was not clinically meaningful. Stroop reaction time for all participants was also slower in the lobby than the lab. All participants slowed their walking speed while generating spontaneous speech, but this effect was not influenced by environment. The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
SIGNIFICANCE


Although dual-tasking slows walking speed and verbal responses to auditory stimuli in people with stroke, the effects are not considerably impacted by a more complex, distracting environment. Adults with and without stroke may have difficulty overriding the preferred attention allocation strategy during dual-task walking, especially for habitual dual-tasks such as walking while speaking. It may also be that the cognitive control strategy governing task prioritization is influenced by degree of cognitive engagement.",2020,"The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
","['Adults with and without stroke', 'adults with and without stroke', 'Adults with stroke (n = 29) as well as age-, gender-, and education-matched adults without stroke (n = 23) participated', 'people with stroke']",['explicit instruction about task prioritization (no-priority) and then with gait-priority instruction and Stroop/speech-priority instruction'],"['walking speed while generating spontaneous speech', 'Stroop reaction time', 'dual-task gait speed']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",23.0,0.0469792,"The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
","[{'ForeName': 'Prudence', 'Initials': 'P', 'LastName': 'Plummer', 'Affiliation': 'Department of Physical Therapy, MGH Institute of Health Professions, 36 1st Avenue, Boston, MA, 02129, United States. Electronic address: pplummer@mghihp.edu.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Altmann', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Feld', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, NC, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zukowski', 'Affiliation': 'Department of Physical Therapy, High Point University, High Point, NC, United States.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Najafi', 'Affiliation': 'Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Giuliani', 'Affiliation': 'Department of Allied Health Sciences, University of North Carolina at Chapel Hill, NC, United States.'}]",Gait & posture,['10.1016/j.gaitpost.2020.03.013']
230,32304981,Opioid overdose reversals using naloxone in New York City by people who use opioids: Implications for public health and overdose harm reduction approaches from a qualitative study.,"BACKGROUND


Adverse reactions to naloxone, such as withdrawal symptoms and aggression, are widely recognised in the literature by pharmaceutical manufacturers and clinical practitioners as standard reactions of individuals who are physically dependent upon opioid drugs following the reversal of potentially fatal opioid overdose. This paper seeks to provide a differentiated view on reactions to naloxone that may have important implications for public health and harm reduction approaches.
METHODS


Analyses from a qualitative investigation embedded within a 5-year Randomised Controlled Trial (RCT) examined the risks and benefits of Overdose Education and Naloxone Distribution (OEND) training models (brief or extended training) in various populations of people who use opioids in New York City. The qualitative experiences (obtained through semi-structured interviews) of 46 people who use opioids and who were each involved in the delivery of naloxone, during 56 separate overdose events that occurred throughout 2016-2018, were studied. Situational analysis and inductive content analysis of interview data focused upon overdose reversals in an attempt to provide understandings of the various adverse effects associated with naloxone from their perspective. These analyses were supplemented by data sessions within the research team during which the findings obtained from situational analysis and inductive content analysis were reviewed and complemented by deductive (clinical) appraisals of the various physical and psychological effects associated with the overdose reversals.
RESULTS


People who use opioids recognise three distinct and interconnected outcomes that may follow a successful opioid overdose reversal after intramuscular or intranasal administration of naloxone. These outcomes are here termed, (i) 'rage' (describing a wide range of angry, hostile and/or aggressive outbursts), (ii) 'withdrawal symptoms,' and (iii) 'not rage, not withdrawal' (i.e., a wide range of short-lived, 'harmless' conditions (such as temporary amnesia, mild emotional outbursts, or physical discomfort) that do not include rage or withdrawal symptoms).
CONCLUSION


Physical and psychological reactions to naloxone should not be understood exclusively as a consequence of acute, opioid-related, withdrawal symptoms. The three distinct and interconnected reversal outcomes identified in this study are considered from a harm reduction policy perspective and are further framed by concepts associated with 'mediated toxicity' (i.e., harm triggered by medicine). The overall conclusion is that harm reduction training programmes that are aligned to the policy and practice of take home naloxone may be strengthened by including awareness and training in how to best respond to 'rage' associated with overdose reversal following naloxone administration by people who use opioids and other laypersons.",2020,"RESULTS


People who use opioids recognise three distinct and interconnected outcomes that may follow a successful opioid overdose reversal after intramuscular or intranasal administration of naloxone.","['46 people who use opioids and who were each involved in the delivery of naloxone, during 56 separate overdose events that occurred throughout 2016-2018, were studied', 'individuals who are physically dependent upon opioid drugs following the reversal of potentially fatal opioid overdose', 'various populations of people who use opioids in New York City']","['Overdose Education and Naloxone Distribution (OEND) training models (brief or extended training', 'naloxone']",['successful opioid overdose reversal'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}]",,0.0390371,"RESULTS


People who use opioids recognise three distinct and interconnected outcomes that may follow a successful opioid overdose reversal after intramuscular or intranasal administration of naloxone.","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Parkin', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom. Electronic address: stephen.parkin@kcl.ac.uk.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Neale', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom; Centre for Social Research in Health, University of New South Wales, Sydney, NSW 2052, Australia.""}, {'ForeName': 'Caral', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom.""}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Castillo', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'Jermaine D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill SE5 8BB, United Kingdom; South London and Maudsley NHS Foundation Trust, Maudsley Hospital, London SE5 8AZ, United Kingdom.""}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 20, New York, NY 10032, United States.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102751']
231,32325415,Whole-body vibration and stretching enhances dorsiflexion range of motion in individuals with chronic ankle instability.,"OBJECTIVE


The purpose of this study was to determine if WBV performed concurrently with static stretching was more effective than static stretching alone to increase dorsiflexion ROM (DFROM) in individuals with chronic ankle instability (CAI).
DESIGN


Controlled laboratory study.
PARTICIPANTS


Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score) were divided into 3 groups (normative (N), static stretch (SS), and static stretch with vibration (SV)). Participants stretched the triceps surae 4 days/wk for 3 wks. Vibration was imposed at 34 Hz and 1.8 mm.
MAIN OUTCOME MEASURES


DFROM was assessed in a straight and bent-leg position.
RESULTS


No differences were detected at any time in the N or SS group, however SS did exhibit large effect sizes with 95% confidence intervals (CI) that did not cross zero from baseline to 3 weeks for both measures. The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
CONCLUSIONS


Static stretching with WBV increases DFROM in participants with CAI more effectively than static stretching alone.",2020,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
","['participants with CAI', 'individuals with chronic ankle instability', 'Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score', 'individuals with chronic ankle instability (CAI']","['static stretch (SS), and static stretch with vibration (SV', 'static stretching', 'static stretching alone']","['DFROM', 'dorsiflexion ROM (DFROM', 'DFROM was assessed in a straight and bent-leg position']","[{'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0231748', 'cui_str': 'Giving-way'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",39.0,0.0500288,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
","[{'ForeName': 'Feland', 'Initials': 'F', 'LastName': 'Jb', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: brent_feland@byu.edu.'}, {'ForeName': 'Thalman', 'Initials': 'T', 'LastName': 'Lesley', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: lesleyabigail@gmail.com.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'I', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: iain_hunter@byu.edu.'}, {'ForeName': 'Cochrane', 'Initials': 'C', 'LastName': 'Dj', 'Affiliation': 'School of Sport, Exercise & Nutrition, Massey University, New Zealand. Electronic address: D.Cochrane@massey.ac.nz.'}, {'ForeName': 'Hopkins', 'Initials': 'H', 'LastName': 'Jt', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: tyhopkins@byu.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.04.001']
232,32179138,Cost-effectiveness of community mobilization (Camino Verde) for dengue prevention in Nicaragua and Mexico: A cluster randomized controlled trial.,"BACKGROUND


We assessed the cost-effectiveness of Camino Verde, a community-based mobilization strategy to prevent and control dengue and other mosquito-borne diseases. A cluster-randomized controlled trial in Managua, Nicaragua, and in three coastal regions in Guerrero, Mexico (75 intervention and 75 control clusters), Camino Verde used non-governmental community health workers, called brigadistas, to support community mobilization. This donor-funded trial demonstrated reductions of 29.5% (95% confidence interval, CI: 3.8%-55.3%) on dengue infections and 24.7% (CI: 1.8%-51.2%) on self-reported cases.
METHODS


We estimated program costs through a micro-costing approach and semi-structured questionnaires. We show results as incremental cost-effectiveness ratios (ICERs) for costs per disability-adjusted life-year (DALYs) averted and conducted probabilistic sensitivity analyses.
FINDINGS


The Camino Verde trial spent US$16.72 in Mexico and $7.47 in Nicaragua per person annually. We found an average of 910 (CI: 487-1 353) and 500 (CI: 250-760) dengue cases averted annually per million population in Mexico and Nicaragua, respectively, compared to control communities. The ICER in Mexico was US$29 618 (CI: 13 869-66 898) per DALY averted, or 3.0 times per capita GDP. For Nicaragua, the ICER was US$29 196 (CI: 14294-72181) per DALY averted, or 16.9 times per capita GDP.
INTERPRETATION


Camino Verde, as implemented in the research context, was marginally cost-effective in Mexico, and not cost-effective in Nicaragua, from a healthcare sector perspective. Nicaragua's low per capita GDP and the use of grant-funded management personnel weakened the cost-effectiveness results. Achieving efficiencies by incorporating Camino Verde activities into existing public health programs would make Camino Verde cost-effective.",2020,Nicaragua's low per capita GDP and use of extra-governmental management personnel weakened the cost-effectiveness results.,"['Nicaragua and Mexico', 'Managua, Nicaragua, and in three coastal regions in Guerrero, Mexico (75 intervention and 75 control clusters), Camino Verde used non-governmental community health workers, called brigadistas, to support community mobilization']",['community mobilization (Camino Verde'],['incremental cost-effectiveness ratios (ICER) for costs per disability-adjusted life-year (DALYs) averted and conducted probabilistic sensitivity analyses'],"[{'cui': 'C0028002', 'cui_str': 'Nicaragua'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0282620', 'cui_str': 'Adjusted Life Years'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",,0.0896247,Nicaragua's low per capita GDP and use of extra-governmental management personnel weakened the cost-effectiveness results.,"[{'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Tschampl', 'Affiliation': 'Schneider Institutes for Health Policy, The Heller School for Social Policy and Management, Brandeis University, Waltham, MA, USA.'}, {'ForeName': 'Eduardo A', 'Initials': 'EA', 'LastName': 'Undurraga', 'Affiliation': 'Escuela de Gobierno, Pontificia Universidad Católica de Chile, Santiago, RM, Chile.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Ledogar', 'Affiliation': 'CIET International, New York, USA.'}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Coloma', 'Affiliation': 'Division of Infectious Diseases and Vaccinology, School of Public Health, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Legorreta-Soberanis', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Acapulco, Mexico.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Paredes-Solís', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Acapulco, Mexico.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Arosteguí', 'Affiliation': 'CIET, Nicaragua.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Hernández-Álvarez', 'Affiliation': 'CIET, Nicaragua.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Harris', 'Affiliation': 'Division of Infectious Diseases and Vaccinology, School of Public Health, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Andersson', 'Affiliation': 'Centro de Investigación de Enfermedades Tropicales (CIET), Universidad Autónoma de Guerrero, Acapulco, Mexico; Department of Family Medicine, McGill University, Montreal, Canada.'}, {'ForeName': 'Donald S', 'Initials': 'DS', 'LastName': 'Shepard', 'Affiliation': 'Schneider Institutes for Health Policy, The Heller School for Social Policy and Management, Brandeis University, Waltham, MA, USA. Electronic address: shepard@brandeis.edu.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.03.026']
233,32199197,Evolving role of regorafenib for the treatment of advanced cancers.,"Regorafenib is an oral tyrosine kinase inhibitor (TKI) approved for the treatment of refractory metastatic colorectal cancer (mCRC), advanced gastrointestinal stromal tumors (GIST) previously treated with imatinib and sunitinib, and unresectable hepatocellular carcinoma (HCC) following progression on sorafenib. Regorafenib was initially approved for mCRC based on improved overall survival (OS) in the randomized, placebo-controlled, phase 3 CORRECT trial, which was confirmed in an expanded population of Asian patients in the randomized, placebo-controlled phase 3 CONCUR trial. Approvals in GIST, and more recently in HCC, were based on the results from the randomized, placebo-controlled, phase 3 GRID and RESORCE trials, respectively. In this review, we provide a comprehensive summary of the clinical evidence for approval of regorafenib in mCRC, GIST, and HCC, present emerging evidence of regorafenib activity in other tumor types (namely, gastroesophageal cancer, sarcomas, biliary tract cancer, and glioblastoma), and discuss trials in progress within the context of regorafenib's mechanism of action. We describe recent advances and key lessons learned with regorafenib, including the importance of managing common drug-related toxicities using dose-optimization strategies, the search for biomarkers to predict response to treatment, and highlight some of the unaddressed questions and future directions for regorafenib across tumors.",2020,"Regorafenib is an oral tyrosine kinase inhibitor (TKI) approved for the treatment of refractory metastatic colorectal cancer (mCRC), advanced gastrointestinal stromal tumors (GIST) previously treated with imatinib and sunitinib, and unresectable hepatocellular carcinoma (HCC) following progression on sorafenib.","['advanced cancers', 'refractory metastatic colorectal cancer (mCRC), advanced gastrointestinal stromal tumors (GIST) previously treated with imatinib and sunitinib, and unresectable hepatocellular carcinoma (HCC) following progression on']","['regorafenib', 'placebo', 'sorafenib', 'Regorafenib', 'oral tyrosine kinase inhibitor (TKI']",['overall survival (OS'],"[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal Stromal Tumors'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.175471,"Regorafenib is an oral tyrosine kinase inhibitor (TKI) approved for the treatment of refractory metastatic colorectal cancer (mCRC), advanced gastrointestinal stromal tumors (GIST) previously treated with imatinib and sunitinib, and unresectable hepatocellular carcinoma (HCC) following progression on sorafenib.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Grothey', 'Affiliation': 'West Cancer Center, Germantown, TN, USA. Electronic address: agrothey@westclinic.com.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Léon Bérard Centre and Claude Bernard University, Lyon, France.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Pavlakis', 'Affiliation': 'Royal North Shore Hospital, St Leonards, Australia.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Bruix', 'Affiliation': 'BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, IDIBAPS, CIBEREHD, Barcelona, Spain.'}]",Cancer treatment reviews,['10.1016/j.ctrv.2020.101993']
234,32208176,The effects of short-term moderate intensity aerobic exercise and long-term detraining on electrocardiogram indices and cardiac biomarkers in postmenopausal women.,"OBJECTIVE


The purpose of this study was to investigate the effects of 12-week of moderate-intensity aerobic exercise and 5-month detraining on electrocardiogram (ECG) indices and serum levels of 25-hydroxivitamin D (Vit D), parathyroid hormone (PTH), calcium (Ca 2+ ), and phosphorus (P) in postmenopausal women (PMWs).
MATERIALS AND METHODS


Thirty-one PMWs (aged 50-70 yrs) were randomized to exercise (EX, n = 16) and control (C, n = 15) groups. EX group performed of 12-week of warm up- walking/jogging moderate intensity aerobic exercise training program- recovery (60 min/day, 3 days/week at 70% of maximal heart rate reserve), and then 5-month detraining remained. C group maintain their normal lifestyle during 8 months. The ECG indices and cardiac serum levels were measured at baseline, after 12-week exercise, and after 5-month detraining.
RESULTS


After 12-week exercise intervention, P-R interval, serum PTH and serum Vit D were significantly increased in the EX group compared to the C group (P = 0.020, P = 0.001 and P = 0.001, respectively). After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group.
CONCLUSIONS


The results suggested that 12-week of moderate intensity aerobic exercise increased the P-R interval, PTH and Vit D, as severe Vit D deficiency status (below 10 ng/ml) improved to Vit D deficiency status (between 10 and 20 ng/ml) in PMWs. Also, long-term positive adaptations to aerobic exercise such as increased Vit D were observed even after 5-month detraining. In addition, P-R segment and S-T interval decreased after 5-month detraining in sedentary PMWs, which may be a sign of atrial positive adaptations to aerobic exercise.",2020,"After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group.
","['postmenopausal women (PMWs', 'postmenopausal women', 'Thirty-one PMWs (aged 50-70\xa0yrs']","['warm up- walking/jogging moderate intensity aerobic exercise training program- recovery', 'exercise (EX', 'short-term moderate intensity aerobic exercise and long-term detraining', 'moderate-intensity aerobic exercise and 5-month detraining', 'moderate intensity aerobic exercise']","['Vit D', 'electrocardiogram (ECG) indices and serum levels of 25-hydroxivitamin D (Vit D), parathyroid hormone (PTH), calcium (Ca 2+ ), and phosphorus (P', 'ECG indices and cardiac serum levels', 'electrocardiogram indices and cardiac biomarkers', 'P-R interval, serum PTH and serum Vit D', 'serum Vit D', 'Vit D deficiency status', 'P-R segment and S-T interval', 'P-R interval, PTH and Vit D, as severe Vit D deficiency status']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0596235', 'cui_str': 'Ca 2+'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0520879', 'cui_str': 'P-R segment, function (observable entity)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.0251744,"After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group.
","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Malandish', 'Affiliation': 'Exercise Physiology, Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran. Electronic address: malandish@gmail.com.'}, {'ForeName': 'Bakhtyar', 'Initials': 'B', 'LastName': 'Tartibian', 'Affiliation': ""Exercise Physiology, Department of Sport Injuries & Corrective Exercises, Faculty of Physical Education & Sport Sciences, Allameh Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Sheikhlou', 'Affiliation': 'Exercise Physiology, Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran.'}, {'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Afsargharehbagh', 'Affiliation': 'Fellowship of Balloon Angioplasty, Department of Interventional Cardiology, Shohada Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rahmati', 'Affiliation': 'Clinical Biochemistry, Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of electrocardiology,['10.1016/j.jelectrocard.2020.03.004']
235,32397978,Reduced frequency of Intravitreal methotrexate injection lowers the risk of Keratopathy in Vitreoretinal lymphoma patients.,"BACKGROUND


Intravitreal methotrexate has been proven to be an effective treatment method for vitreoretinal lymphoma. However, keratopathy occurs as the major side effect during treatment in most cases. The purpose of this study is to describe the characteristics of primary central nervous system lymphoma (PCNSL) with intraocular involvement and to attempt to reduce the incidence of keratopathy caused by intravitreal methotrexate.
METHODS


The medical records of 22 PCNSL patients with intraocular involvement (33 eyes) were reviewed. Patients were divided into two groups. Group A (22 eyes) received the induction-consolidation-maintenance regimen, which consisted of intravitreal methotrexate injection at a dosage of 400 μg/0.1 ml twice a week for the first four weeks, weekly for the following eight weeks, and then monthly for the last nine months. Patients with a poor systemic condition were assigned to Group B (8 eyes), who were started on the treatment protocol described above and switched directly to monthly injection (9 months) when ocular remission was achieved.
RESULTS


Blurred vision (31%) and floaters (25%) were common presenting symptoms. Vitritis was the most common clinical sign and was present in 29 eyes (90%) on B-ultrasound examination. Diagnosis was made by 25G-pars plana vitrectomy, and most diagnoses were diffuse large B-cell lymphoma. Ocular remission was achieved after 8.2 (SD = 4.6) injections of methotrexate. The mean VA (visual acuity) was improved from LogMAR 0.65 to 0.3 (P = 0.002). Keratopathy was observed in 21 eyes (66%) after an average of 8.2 (SD = 2.3) injections. With a reduced injection frequency, the incidence of keratopathy was lowered from 86.4% (Group A) to 25.0% (Group B) without ocular recurrence during follow-up.
CONCLUSIONS


Intravitreal methotrexate is a safe, effective and flexible treatment for PCNSL patients with intraocular involvement. Keratopathy is the most common adverse effect and can be controlled by reducing the injection frequency.",2020,Vitritis was the most common clinical sign and was present in 29 eyes (90%) on B-ultrasound examination.,"['Patients with a poor systemic condition', 'Vitreoretinal lymphoma patients', 'PCNSL patients with intraocular involvement', '22 PCNSL patients with intraocular involvement (33 eyes']","['25G-pars plana vitrectomy', 'Intravitreal methotrexate injection', 'methotrexate', 'induction-consolidation-maintenance regimen, which consisted of intravitreal methotrexate injection']","['Blurred vision', 'ocular recurrence', 'Ocular remission', 'Keratopathy', 'incidence of keratopathy', 'mean VA (visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0280803', 'cui_str': 'Primary central nervous system lymphoma'}, {'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4034144', 'cui_str': 'Methotrexate Injection'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0235270', 'cui_str': 'Keratopathy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",,0.014977,Vitritis was the most common clinical sign and was present in 29 eyes (90%) on B-ultrasound examination.,"[{'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital North, Fudan University, Shanghai, China.'}, {'ForeName': 'Xianjin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital, Fudan University, No.12 Wulumuqi Road, Shanghai, 200040, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital North, Fudan University, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital, Fudan University, No.12 Wulumuqi Road, Shanghai, 200040, China.'}, {'ForeName': 'Qingping', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital North, Fudan University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital North, Fudan University, Shanghai, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Laboratory Medicine, Huashan Hospital North, Fudan University, Shanghai, China.'}, {'ForeName': 'Qingjian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital, Fudan University, No.12 Wulumuqi Road, Shanghai, 200040, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital North, Fudan University, Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital North, Fudan University, Shanghai, China.'}, {'ForeName': 'Bobin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Huashan Hospital, Fudan University, No.12 Wulumuqi Road, Shanghai, 200040, China.'}, {'ForeName': 'Jianjiang', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital North, Fudan University, Shanghai, China. jianjiangxiao@163.com.'}]",BMC ophthalmology,['10.1186/s12886-020-01464-3']
236,32397980,"Efficacy and safety of myrrh in patients with incomplete abortion: a randomized, double-blind, placebo-controlled clinical study.","BACKGROUND


Myrrh (Commiphora myrrha (Nees) Engl.) has a long history of traditional use as a herbal medicine for different purposes. In ancient traditional Persian manuscripts, it has been noted that myrrh may act as uterine stimulant and probably cause complete abortion. However, there is no evidence to verify this comment. Therefore, the current study was carried out to evaluate the efficacy and safety of Myrrh in the treatment of incomplete abortion.
MATERIALS AND METHODS


In a randomized double-blinded placebo controlled clinical trial, 80 patients with ultrasound-documented retained products of conception (RPOC) were assigned to receive capsules containing 500 mg of Myrrh oleo-gum-resin or a placebo three times a day for 2 weeks. The existence of the retained tissue and its size were evaluated by ultrasound examination at the beginning and end of the study.
RESULTS


After 2 weeks, the mean diameter of the RPOC in the Myrrh group was significantly reduced compared with the placebo group (P < 0.001). Meanwhile, the rate of successful complete abortion was 82.9% in the intervention group and 54.3% in the placebo group (P = 0.01). The patients in both groups reported no serious drug-related adverse effects.
CONCLUSION


This study shows that Myrrh is effective and safe in the resolution of the RPOC and may be considered as an alternative option for treatment of patients with incomplete abortion. However, further studies on active compounds isolated from myrrh and their uterine stimulant effects are needed.
TRIAL REGISTRATION


This study was retrospectively registered at Iranian Registry of Clinical Trials (www.irct.ir) IRCT code: IRCT20140317017034N7.",2020,"After 2 weeks, the mean diameter of the RPOC in the Myrrh group was significantly reduced compared with the placebo group (P < 0.001).","['patients with incomplete abortion', '80 patients with ultrasound-documented retained products of conception (RPOC']","['capsules containing 500\u2009mg of Myrrh oleo-gum-resin or a placebo', 'placebo']","['efficacy and safety of Myrrh', 'Efficacy and safety', 'rate of successful complete abortion', 'no serious drug-related adverse effects', 'mean diameter of the RPOC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000810', 'cui_str': 'Incomplete miscarriage'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0033270', 'cui_str': 'Retained products of conception'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0230953', 'cui_str': 'Structure of product of conception'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0207011', 'cui_str': 'Myrrh extract'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0207011', 'cui_str': 'Myrrh extract'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0233105', 'cui_str': 'Abortion complete'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0033270', 'cui_str': 'Retained products of conception'}]",80.0,0.464431,"After 2 weeks, the mean diameter of the RPOC in the Myrrh group was significantly reduced compared with the placebo group (P < 0.001).","[{'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ajdari', 'Affiliation': 'Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ayda', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. nasadi2012@yahoo.ca.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Abolhasanzadeh', 'Affiliation': 'Department of Radiology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Khadije', 'Initials': 'K', 'LastName': 'Bazrafshan', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02946-z']
237,32398024,Web-based exercise versus supervised exercise for decreasing visceral adipose tissue in older adults with central obesity: a randomized controlled trial.,"BACKGROUND


Visceral adipose tissue (VAT) is a strong risk factor for cardiovascular disease and increases with age. While supervised exercise (SE) may be an effective approach, web-based exercise (WE) have other advantages such as being more readily accessible. Therefore, we evaluated the effects of WE on VAT, body composition and cardiometabolic risk markers in centrally obese older adults and compared the effects of WE to SE. We also explored the feasibility of WE.
METHODS


In a randomized controlled trial conducted in Umeå, Sweden during January 2018 - November 2018, N = 77, 70-year-old men and women with central obesity (> 1 kg VAT for women, > 2 kg for men) were randomized to an intervention group (n = 38) and a wait-list control group (n = 39). The intervention group received 10 weeks of SE while the wait-list control group lived as usual. Following a 10-week wash-out-period, the wait-list control group received 10 weeks of WE. The primary outcome was changes in VAT. Secondary outcomes included changes in fat mass (FM), lean body mass (LBM), blood lipids, fasting blood glucose. Additionally, we explored the feasibility of WE defined as adherence and participant experiences.
RESULTS


WE had no significant effect on VAT (P = 0.5), although it decreased FM by 450 g (95% confidence interval [CI], 37 to 836, P < 0.05). The adherence to WE was 85% and 87-97% of the participants rated aspects of the WE intervention > 4 on a scale of 1-5. Comparing SE to WE, there was no significant difference in decrease of VAT (Cohen's δ effect size [ES], 0.5, 95% CI, - 24 to 223, P = 0.11), although SE decreased FM by 619 g (ES, 0.5, 95% CI, 22 to 1215, P < 0.05) compared to WE.
CONCLUSIONS


Ten weeks of vigorous WE is insufficient to decrease VAT in centrally obese older adults, but sufficient to decrease FM while preserving LBM. The high adherence and positive experiences of the WE intervention implies that it could serve as an alternative exercise strategy for older adults with central obesity, with increased availability for a larger population.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03450655), retrospectively registered February 28, 2018.",2020,"WE had no significant effect on VAT (P = 0.5), although it decreased FM by 450 g (95% confidence interval [CI], 37 to 836, P < 0.05).","['older adults with central obesity', 'Umeå, Sweden during January 2018 - November 2018, N\u2009=\u200977, 70-year-old men and women with central obesity (>\u20091\u2009kg VAT for women, >\u20092\u2009kg for men', 'centrally obese older adults']","['Web-based exercise versus supervised exercise', 'wait-list control group', 'supervised exercise (SE', '10\u2009weeks of SE while the wait-list control group lived as usual']","['VAT', 'changes in fat mass (FM), lean body mass (LBM), blood lipids, fasting blood glucose', 'changes in VAT', 'VAT, body composition and cardiometabolic risk markers', 'SE decreased FM']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.245774,"WE had no significant effect on VAT (P = 0.5), although it decreased FM by 450 g (95% confidence interval [CI], 37 to 836, P < 0.05).","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Ballin', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Unit of Geriatric Medicine, Umeå University, 901 87, Umeå, Sweden. marcel.ballin@umu.se.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hult', 'Affiliation': 'Department of Public Health and Clinical Medicine, Section of Sustainable Health, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Björk', 'Affiliation': 'Department of Public Health and Clinical Medicine, Section of Sustainable Health, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Emmy', 'Initials': 'E', 'LastName': 'Lundberg', 'Affiliation': 'Department of Public Health and Clinical Medicine, Section of Sustainable Health, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Unit of Geriatric Medicine, Umeå University, 901 87, Umeå, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nordström', 'Affiliation': 'Department of Public Health and Clinical Medicine, Section of Sustainable Health, Umeå University, Umeå, Sweden.'}]",BMC geriatrics,['10.1186/s12877-020-01577-w']
238,32398040,PEACE V - Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): a study protocol for a randomized controlled phase II trial.,"BACKGROUND


Pelvic nodal recurrences are being increasingly diagnosed with the introduction of new molecular imaging techniques, like choline and PSMA PET-CT, in the restaging of recurrent prostate cancer (PCa). At this moment, there are no specific treatment recommendations for patients with limited nodal recurrences and different locoregional treatment approaches are currently being used, mostly by means of metastasis-directed therapies (MDT): salvage lymph node dissection (sLND) or stereotactic body radiotherapy (SBRT). Since the majority of patients treated with MDT relapse within 2 years in adjacent lymph node regions, with an estimated median time to progression of 12-18 months, combining MDT with whole pelvic radiotherapy (WPRT) may improve oncological outcomes in these patients. The aim of this prospective multicentre randomized controlled phase II trial is to assess the impact of the addition of WPRT to MDT and short-term androgen deprivation therapy (ADT) on metastasis-free survival (MFS) in the setting of oligorecurrent pelvic nodal recurrence.
METHODS & DESIGN


Patients diagnosed with PET-detected pelvic nodal oligorecurrence (≤5 nodes) following radical local treatment for PCa, will be randomized in a 1:1 ratio between arm A: MDT and 6 months of ADT, or arm B: WPRT added to MDT and 6 months of ADT. Patients will be stratified by type of PET-tracer (choline, FACBC or PSMA) and by type of MDT (sLND or SBRT). The primary endpoint is MFS and the secondary endpoints include clinical and biochemical progression-free survival (PFS), prostate cancer specific survival, quality of life (QoL), toxicity and time to castration-resistant prostate cancer (CRPC) and to palliative ADT. Estimated study completion: December 31, 2023.
DISCUSSION


This is the first prospective multicentre randomized phase II trial assessing the potential of combined WPRT and MDT as compared to MDT alone on MFS for patients with nodal oligorecurrent PCa.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03569241, registered June 14, 2018, ; Identifier on Swiss National Clinical Trials Portal (SNCTP): SNCTP000002947, registered June 14, 2018.",2020,"At this moment, there are no specific treatment recommendations for patients with limited nodal recurrences and different locoregional treatment approaches are currently being used, mostly by means of metastasis-directed therapies (MDT): salvage lymph node dissection (sLND) or stereotactic body radiotherapy (SBRT).","['patients with nodal oligorecurrent PCa', 'OligoRecurrent nodal prostate cancer Metastases (STORM', 'Patients diagnosed with PET-detected pelvic nodal oligorecurrence (≤5 nodes) following', 'registered June 14, 2018, ; Identifier on Swiss National Clinical Trials Portal (SNCTP']","['radical local treatment for PCa', 'WPRT', 'combined WPRT and MDT', 'stereotactic body radiotherapy (SBRT', 'MDT alone on MFS', 'MDT (sLND or SBRT', 'MDT with whole pelvic radiotherapy (WPRT', 'WPRT to MDT and short-term androgen deprivation therapy (ADT', 'PEACE V - Salvage Treatment']","['clinical and biochemical progression-free survival (PFS), prostate cancer specific survival, quality of life (QoL), toxicity and time to castration-resistant prostate cancer (CRPC) and to palliative ADT', 'metastasis-free survival (MFS', 'oncological outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205054', 'cui_str': 'Portal'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.149516,"At this moment, there are no specific treatment recommendations for patients with limited nodal recurrences and different locoregional treatment approaches are currently being used, mostly by means of metastasis-directed therapies (MDT): salvage lymph node dissection (sLND) or stereotactic body radiotherapy (SBRT).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'De Bruycker', 'Affiliation': 'Department of Radiation oncology and experimental cancer research, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Spiessens', 'Affiliation': 'Department of Radiation oncology and experimental cancer research, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Dirix', 'Affiliation': 'Department of Radiation oncology, Iridium Cancer Network, GZ Antwerp, Antwerp, Belgium.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Koutsouvelis', 'Affiliation': 'Department of Radiation oncology, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Semac', 'Affiliation': 'Department of Radiation oncology, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Liefhooghe', 'Affiliation': 'Department of Radiation oncology, AZ Groeninge, Kortrijk, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gomez-Iturriaga', 'Affiliation': 'Cruces University Hospital (Biocruces Health Research Institute), Barakaldo, Spain.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Everaerts', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Otte', 'Affiliation': 'Department of Radiation oncology, Jules Bordet Institute and Hôpital Erasme, University Clinics of Brussels, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Papachristofilou', 'Affiliation': 'Clinic of Radiotherapy & Radiation Oncology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Scorsetti', 'Affiliation': 'Humanitas Clinical and Research Hospital, IRCSS, Radiotherapy and Radiosurgery Department, Rozzano, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shelan', 'Affiliation': 'Department of Radiation oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Siva', 'Affiliation': 'Epworth Healthcare, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ameye', 'Affiliation': 'Department of Urology, AZ Maria-Middelares Ghent, Ghent, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Guckenberger', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zürich, University of Zurich, Zürich, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Heikkilä', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Putora', 'Affiliation': 'Department of Radiation oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zapatero', 'Affiliation': 'University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Conde-Moreno', 'Affiliation': 'Department of Radiation oncology, Hospital Universitari i Politècnic la Fe, Valencia, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Couñago', 'Affiliation': 'Department of Radiation oncology, University Hospital of Quirón, Madrid, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vanhoutte', 'Affiliation': 'Department of Radiation oncology and experimental cancer research, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Goetghebeur', 'Affiliation': 'Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Reynders', 'Affiliation': 'Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zilli', 'Affiliation': 'Department of Radiation oncology, Geneva University Hospital, Geneva, Switzerland. Thomas.Zilli@hcuge.ch.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ost', 'Affiliation': 'Department of Radiation oncology and experimental cancer research, Ghent University Hospital, Ghent, Belgium. piet.ost@ugent.be.'}]",BMC cancer,['10.1186/s12885-020-06911-4']
239,32396474,Factors Associated with HIV Disclosure Status Among iENGAGE Cohort of New to HIV Care Patients.,"HIV disclosure is an important behavior with implications for HIV treatment and prevention but understudied among new to HIV care patients who face unique challenges adjusting to a new diagnosis. This study evaluated the factors associated with HIV disclosure status and patterns of HIV disclosure among new to HIV care patients. A cross-sectional study was conducted evaluating the iENGAGE (integrating ENGagement and Adherence Goals upon Entry) cohort. Participants were enrolled in this randomized behavioral trial between December 2013 and June 2016. The primary and secondary outcomes included HIV disclosure status (Yes/No) and patterns of disclosure (Broad, Selective and Nondisclosure), respectively. Logistic and Multinomial Logistic Regression were used to evaluate the association of participant factors with HIV disclosure and patterns of HIV disclosure, respectively. Of 371 participants, the average age was 37 ± 12 years, 79.3% were males, and 62.3% were African Americans. A majority of participants (78.4%) disclosed their HIV status at baseline, 63.1% were broad disclosers and 15.2% were selective disclosers. In multivariable regression, black race, emotional support, and unmet needs predicted any HIV and broad disclosure, whereas males, emotional support, active coping, and acceptance were associated with selective disclosure. Interventions to promote early disclosure should focus on coping strategies and unmet needs, particularly among black and male people living with HIV initiating care.",2020,"A majority of participants (78.4%) disclosed their HIV status at baseline, 63.1% were broad disclosers and 15.2% were selective disclosers.","['Of 371 participants, the average age was 37\u2009±\u200912 years, 79.3% were males, and 62.3% were African Americans', 'Participants were enrolled in this randomized behavioral trial between December 2013 and June 2016', 'black and male people living with HIV initiating care', 'HIV care patients']",[],"['HIV status', 'males, emotional support, active coping, and acceptance', 'HIV disclosure status and patterns of HIV disclosure', 'HIV disclosure status (Yes/No) and patterns of disclosure (Broad, Selective and Nondisclosure', 'HIV Disclosure Status']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0332464', 'cui_str': 'Widening'}]",,0.0384234,"A majority of participants (78.4%) disclosed their HIV status at baseline, 63.1% were broad disclosers and 15.2% were selective disclosers.","[{'ForeName': 'Riddhi A', 'Initials': 'RA', 'LastName': 'Modi', 'Affiliation': 'Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'McGwin', 'Affiliation': 'Department of Epidemiology, and University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Willig', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Andrew O', 'Initials': 'AO', 'LastName': 'Westfall', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Griffin', 'Affiliation': 'Department of Epidemiology, and University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Rivet', 'Initials': 'R', 'LastName': 'Amico', 'Affiliation': 'Department of Health Behavior and Education, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Kimberly D', 'Initials': 'KD', 'LastName': 'Martin', 'Affiliation': 'Department of Epidemiology, and University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Raper', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jeanne C', 'Initials': 'JC', 'LastName': 'Keruly', 'Affiliation': 'Department of Medicine, Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Golin', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zinski', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Napravnik', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Crane', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mugavero', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}]",AIDS patient care and STDs,['10.1089/apc.2019.0271']
240,32335288,The 'Take a Break' game: Randomized trial protocol for a technology-assisted brief abstinence experience designed to engage lower-motivated smokers.,"BACKGROUND


While smoking continues to be the most preventable cause of mortality in the United States, most current smokers remain not ready to quit at any given time. Engaging these 'motivation phase' smokers with brief experiences to build confidence and practice skills related to cessation could lead to sooner and more successful quit attempts. Increasingly available mobile technology and gamification can be used to provide smokers with accessible and engaging support.
METHODS


We describe our protocol for conducting a randomized controlled trial evaluating Take a Break, an mHealth-based smoking pre-cessation challenge designed for smokers not ready to quit. Participants in the intervention receive 1) Motivational Messages, 2) text message Challenge Quizzes, 3) Goal-setting with tobacco treatment specialist, 4) Coping Mini-Games apps, and 5) Recognition and Rewards for participation during a 3-week challenge. Access to coping mini-games and motivational messaging continues for 6-months. Both intervention and comparison group participants receive brief Nicotine Replacement Therapy (NRT) sampling and daily smoking assessment text messages for three weeks. Primary outcomes include number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation at six months.
CONCLUSION


Take a Break is an innovative approach to engage those not prepared for a quit attempt. Take a Break provides motivation phase smokers with tools and a brief experience to prepare them for a quit attempt, filling a gap in tobacco cessation support and current research.",2020,"Primary outcomes include number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation at six months.
","['engage lower-motivated smokers', 'smokers not ready to quit']","['Motivational Messages, 2) text message Challenge Quizzes, 3) Goal-setting with tobacco treatment specialist, 4) Coping Mini-Games apps, and 5) Recognition and Rewards for participation during a 3-week challenge', 'Nicotine Replacement Therapy (NRT) sampling and daily smoking assessment text messages']","['number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3853073', 'cui_str': 'Smoking assessment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.0313065,"Primary outcomes include number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation at six months.
","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Amante', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America. Electronic address: daniel.amante@umassmed.edu.'}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Blok', 'Affiliation': 'VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, United States Department of Veterans Affairs, Ann Arbor, MI, United States of America; Systems, Populations and Leadership Department, School of Nursing, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Nagawa', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jessica G', 'Initials': 'JG', 'LastName': 'Wijesundara', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jeroan J', 'Initials': 'JJ', 'LastName': 'Allison', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Sharina D', 'Initials': 'SD', 'LastName': 'Person', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Morley', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America; Feinstein Institute for Medical Research, Manhasset, NY, United States of America.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Conigliaro', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America; Feinstein Institute for Medical Research, Manhasset, NY, United States of America.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Mattocks', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America; VA Central Western Massachusetts Healthcare System, Leeds, MA, United States of America.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Garber', 'Affiliation': 'Reliant Medical Group, Worcester, MA, United States of America.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Houston', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America; Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Rajani S', 'Initials': 'RS', 'LastName': 'Sadasivam', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106002']
241,32272255,COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial.,"BACKGROUND


Dual antiplatelet therapy constitutes the cornerstone of medical treatment in patients with ST elevation myocardial infarction (STEMI). However, oral antiplatelet agents, such as prasugrel or ticagrelor, are characterized by slow gastrointestinal drug absorption in the acute phase of STEMI, leading to decreased bioavailability and therefore delayed onset of platelet inhibition. Evidence suggests that administration of crushed tablets of the P2Y 12  inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI). However, the clinical implications of these pharmacokinetic and pharmacodynamic findings are unknown.
HYPOTHESIS


The present study is designed to test the hypothesis that patients presenting with STEMI planned for primary PCI will have improved markers of optimal reperfusion and clinical outcomes by prehospital administration of crushed tablets of prasugrel loading dose.
STUDY DESIGN


COMPARE CRUSH (NCT03296540) is a randomized trial in a regionally organized ambulance care setting evaluating the efficacy and safety of pre-hospital loading dose with prasugrel crushed tablets versus integral tablets in approximately 674 patients presenting with STEMI planned for primary PCI. The independent primary endpoints are percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution at 1 hour post-PCI. Secondary clinical endpoints are death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year. Moreover, the primary safety endpoint is bleeding events assessed at 48 hours.
CONCLUSIONS


The COMPARE CRUSH trial will assess whether prehospital administration of loading dose prasugrel in form of crushed tablets - which is expected to provide faster platelet inhibition compared to standard treatment with integral tablets - results in improved reperfusion and clinical outcomes. RCT# NCT03296540.",2020,Evidence suggests that administration of crushed tablets of the P2Y 12  inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI).,"['patients with ST elevation myocardial infarction (STEMI', 'patients with STEMI undergoing primary percutaneous coronary interventions', 'approximately 674 patients presenting with STEMI planned for primary PCI', 'patients presenting with STEMI planned for primary PCI', 'STEMI patients undergoing primary percutaneous coronary intervention (PCI']","['Prasugrel tablets', 'prasugrel crushed tablets']","['death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year', 'bleeding events', 'percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C2710119', 'cui_str': 'prasugrel Oral Tablet'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}]",674.0,0.146697,Evidence suggests that administration of crushed tablets of the P2Y 12  inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI).,"[{'ForeName': 'Georgios J', 'Initials': 'GJ', 'LastName': 'Vlachojannis', 'Affiliation': 'Maasstad Hospital, Rotterdam; University Medical Center Utrecht, Netherlands. Electronic address: g.vlachojannis@umcutrecht.nl.'}, {'ForeName': 'Rosanne F', 'Initials': 'RF', 'LastName': 'Vogel', 'Affiliation': 'University Medical Center Utrecht, Netherlands.'}, {'ForeName': 'Jeroen M', 'Initials': 'JM', 'LastName': 'Wilschut', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Miguel E', 'Initials': 'ME', 'LastName': 'Lemmert', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'Academic Medical Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diletti', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'van Vliet', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'van der Waarden', 'Affiliation': 'Ambulance Zorg Rotterdam-Rijnmond, Rotterdam, Netherlands.'}, {'ForeName': 'Rutger-Jan', 'Initials': 'RJ', 'LastName': 'Nuis', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Paradies', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Alexopoulos', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Zijlstra', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne University, ACTION Group, Groupe Hospitalier Pitie-Salpetriere Hospital (AP-HP), Paris, France.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine, Jacksonville, FL, USA.'}, {'ForeName': 'Mitchell W', 'Initials': 'MW', 'LastName': 'Krucoff', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}]",American heart journal,['10.1016/j.ahj.2020.03.005']
242,32289571,A picture is worth a thousand words: The effect of viewing celebrity Instagram images with disclaimer and body positive captions on women's body image.,"Research has shown that exposure to Instagram images is harmful for women's body image. Although Instagram consists of photos of both peers and celebrities, the top followed Instagram accounts are held by thin and attractive female celebrities. The present study aimed to experimentally investigate whether two forms of Instagram caption could mitigate the detrimental effect of celebrity images on women's body image. Participants were 256 female undergraduate students who were assigned to view a set of celebrity images with either no caption, a disclaimer caption, or a body positive caption, or a control set of travel images. Results showed that exposure to celebrity images, in comparison to travel images, increased body dissatisfaction and decreased body appreciation. However, there was no significant effect of either form of caption. The effect of celebrity images was mediated by state appearance comparison and moderated by trait appearance comparison. It was concluded that the addition of disclaimer or body positive captions by attractive celebrities does not serve to improve women's body image.",2020,"Results showed that exposure to celebrity images, in comparison to travel images, increased body dissatisfaction and decreased body appreciation.","['Participants were 256 female undergraduate students', ""women's body image""]","['celebrity images with either no caption, a disclaimer caption, or a body positive caption, or a control set of travel images']",['body dissatisfaction and decreased body appreciation'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0015621', 'cui_str': 'Famous Persons'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0040802', 'cui_str': 'Travel'}]","[{'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]",256.0,0.0238411,"Results showed that exposure to celebrity images, in comparison to travel images, increased body dissatisfaction and decreased body appreciation.","[{'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Brown', 'Affiliation': 'Flinders University, Australia. Electronic address: zoe.brown@flinders.edu.au.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'Flinders University, Australia.'}]",Body image,['10.1016/j.bodyim.2020.03.003']
243,32289741,Dulaglutide reduces binge episodes in type 2 diabetic patients with binge eating disorder: A pilot study.,"AIMS


Binge eating disorder (BED) is the most common eating disorder in the United States and Europe and is associated with obesity and type 2 diabetes (T2D). Presence and severity of BED have been associated with worse metabolic control and greater BMI in T2D patients. Glucagon Like Peptide-1 (GLP1) receptors are present in central nervous system areas involved in appetite regulation and treatment with GLP-1 receptor agonists modulates appetite and reward-related brain areas in humans. We evaluated the effects of treatment with dulaglutide on eating behavior in T2D outpatients with BED.
METHODS


This was a pilot open label, prospective controlled study. Inclusion criteria were: Age ≤65, HbA1c between 7.5 and 9% on metformin therapy alone, normal renal function and diagnosis of BED. Patients were randomly assigned to receive either Dulaglutide 1,5 mg/sett or Gliclazide 60 mg for 12 weeks. We evaluated baseline binge eating scale score (BES), weight, BMI, percentage fat mass, HbA1c and their changes after treatment. A multivariate linear regression model was used to verify the association between Δ BES from baseline with Δ Hba1c and variation of anthropometric parameters after treatment.
RESULTS


After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide. Reduction in BES was associated with reduction in body weight (p < 0.0001) and HbA1c (p = 0.033).
CONCLUSION


Dulaglutide treatment reduces binge eating behaviour in T2D patients with BED.",2020,"After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide.","['T2D patients', 'type 2 diabetic patients with binge eating disorder', 'T2D outpatients with BED', 'Inclusion criteria were: Age ≤65, HbA1c between 7.5 and 9% on metformin therapy alone, normal renal function and diagnosis of BED', 'T2D patients with BED']","['Dulaglutide 1,5 mg/sett or Gliclazide', 'Dulaglutide treatment', 'dulaglutide', 'Dulaglutide', 'gliclazide']","['BMI', 'percentage fat mass', 'binge eating behaviour', 'binge episodes', 'baseline binge eating scale score (BES), weight, BMI, percentage fat mass, HbA1c and their changes', 'Reduction in BES', 'eating behavior', 'body weight']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0451027', 'cui_str': 'Binge eating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",,0.0375975,"After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Da Porto', 'Affiliation': 'Internal Medicine, University of Udine, Italy. Electronic address: daporto.andrea@gmail.com.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Casarsa', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Catena', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Cavarape', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Sechi', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.03.009']
244,32305787,A prospective randomized controlled study of combined spinal-general anesthesia vs. general anesthesia for laparoscopic gynecological surgery: Opioid sparing properties.,"STUDY OBJECTIVE


We aimed to determine the magnitude of peri-operative opioid sparing effect when general anesthesia is combined with spinal analgesia for laparoscopic gynecological surgery.
DESIGN


A prospective randomized controlled study; a three-group trial with two comparisons (each intervention group to control).
SETTING


Operating room and postoperative recovery area.
PATIENTS


Patients aged between 18 and 65 years with American Society of Anesthesiologists physical status 1 or 2 who were scheduled for inpatient elective laparoscopic gynecological surgery with expected pneumoperitoneum duration of at least 20 min. Of 102 randomized patients, 99 completed the study.
INTERVENTIONS


Patients were randomized to general anesthesia alone (control group) or combined with very-low-dose (levobupivacaine 3.75 mg; sufentanil 2.5 μg) or low-dose (levobupivacaine 7.5 mg; sufentanil 2.5 μg) spinal analgesia.
MEASUREMENTS


Primary endpoints were perioperative opioid consumption and pain scores (11-point numeric rating scale) at 30 min, 1 h, 2 h, 4 h and 24 h post-surgery. Secondary endpoints were patient satisfaction with anesthetic care and participation in research, sevoflurane consumption and adverse effects.
MAIN RESULTS


Intra-operative sufentanil (median [95% CI]) consumption was 16.1 (10.5-22.6) μg/h in the control group versus 4.7 (3.2-9.2) μg/h in the very-low-dose and versus 2.9 (0.0-4.0) μg/h in the low-dose spinal analgesia groups (p < 0.001, for both comparisons). Median (95% CI) piritramide consumption at 24 h post-surgery was 7.5 (3-8) mg in the control group versus 5 (0-7.5) mg in the very-low dose spinal analgesia group (p = 0.182) and versus 2 (0-2.5) mg in the low-dose spinal analgesia group (p = 0.001). Postoperative pain scores were consistently <3 only in the low dose spinal analgesia group. Patient satisfaction with anesthetic care and participation in research was very high in all groups.
CONCLUSIONS


Low-dose spinal analgesia in combination with general anesthesia reduces peri-operative opioid consumption in laparoscopic gynecological surgery in immediate postoperative period.",2020,"CONCLUSIONS


Low-dose spinal analgesia in combination with general anesthesia reduces peri-operative opioid consumption in laparoscopic gynecological surgery in immediate postoperative period.","['102 randomized patients, 99 completed the study', 'laparoscopic gynecological surgery', 'Patients aged between 18 and 65\xa0years with American Society of Anesthesiologists physical status 1 or 2 who were scheduled for inpatient elective laparoscopic gynecological surgery with expected pneumoperitoneum duration of at least 20\xa0min']","['combined spinal-general anesthesia vs. general anesthesia', 'spinal analgesia', 'general anesthesia alone (control group) or combined with very-low-dose (levobupivacaine 3.75\xa0mg; sufentanil 2.5\xa0μg) or low-dose (levobupivacaine 7.5\xa0mg; sufentanil 2.5\xa0μg) spinal analgesia']","['Postoperative pain scores', 'perioperative opioid consumption and pain scores (11-point numeric rating scale) at 30\xa0min, 1\xa0h, 2\xa0h, 4\xa0h and 24\xa0h post-surgery', 'peri-operative opioid consumption', 'patient satisfaction with anesthetic care and participation in research, sevoflurane consumption and adverse effects', 'piritramide consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C1963862', 'cui_str': 'Spinal analgesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C4517697', 'cui_str': '3.75'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C4517859', 'cui_str': '7.5'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0031982', 'cui_str': 'Pirinitramide'}]",102.0,0.196443,"CONCLUSIONS


Low-dose spinal analgesia in combination with general anesthesia reduces peri-operative opioid consumption in laparoscopic gynecological surgery in immediate postoperative period.","[{'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Zdravkovic', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Management, University Medical Centre Maribor, Ljubljanska ulica 5, 2000 Maribor, Slovenia; Faculty of Medicine, University of Maribor, Taborska ulica 8, 2000 Maribor, Slovenia. Electronic address: markozdravkovic@gmail.com.'}, {'ForeName': 'Mirt', 'Initials': 'M', 'LastName': 'Kamenik', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Management, University Medical Centre Maribor, Ljubljanska ulica 5, 2000 Maribor, Slovenia; Faculty of Medicine, University of Maribor, Taborska ulica 8, 2000 Maribor, Slovenia.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109808']
245,32305794,Hemodynamic profiles with and without left uterine displacement: A randomized study in term pregnancies receiving subarachnoid blockade for cesarean delivery.,"STUDY OBJECTIVE


The aim of this study was to evaluate the effect of left uterine displacement (LUD) on maternal hemodynamic measures following subarachnoid blockade (SAB) for cesarean delivery (CD). The primary outcome was cardiac output (CO) differences between the LUD and non-LUD groups pre-delivery.
DESIGN


Prospective, randomized, controlled study.
SETTING


Obstetric operating room.
MATERIALS AND METHODS


We studied hemodynamic profiles in sixty healthy women with term pregnancies who underwent elective CD with SAB. Hemodynamics were measured using a non-invasive CO monitor, the Nexfin™. All women received a crystalloid 10 mL/kg preload, and hypotension was treated with ephedrine boluses.
INTERVENTIONS


Sixty women with term pregnancies were randomized into two groups: LUD group (received 15-30° LUD after SAB, n = 30) and non-LUD group (no LUD after SAB, n = 30).
MEASUREMENTS


Patient's hemodynamic variables including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), CO, systemic vascular resistance (SVR), and left ventricular contractility index (dP/dT) were measured continuously from pre-SAB until end of surgery.
MAIN RESULTS


In pre-delivery phase at 5 min after spinal anesthesia, the LUD group had significantly higher CO (7.20 ± 1.78 [95%CI 6.53-7.87] vs. 6.23 ± 1.44 L/min [95% CI 5.69-6.77]; p = 0.016) and higher dP/dT (784 ± 313 vs. 604 ± 241 mmHg/s; p = 0.020) than the non-LUD group. The LUD group had a lower incidence of maternal systolic hypotension at 5-min post-SAB (16.7% vs. 53.3% in non-LUD group, p = 0.003).
CONCLUSIONS


The study demonstrates modest hemodynamic advantages (higher CO, less hypotension, higher dP/dT) with pre-delivery LUD. The results support maternal hemodynamic benefits of LUD until delivery in women with term pregnancies undergoing CD with SAB.",2020,"The LUD group had a lower incidence of maternal systolic hypotension at 5-min post-SAB (16.7% vs. 53.3% in non-LUD group, p = 0.003).
","['sixty healthy women with term pregnancies who underwent elective CD with SAB', 'Sixty women with term pregnancies', 'Obstetric operating room', 'term pregnancies receiving subarachnoid blockade for cesarean delivery', 'women with term pregnancies undergoing CD with SAB', 'cesarean delivery (CD', '313 vs. 604\xa0±', '241', 'Hemodynamic profiles with and without left uterine displacement']","['ephedrine boluses', 'left uterine displacement (LUD', 'crystalloid 10\xa0mL/kg preload, and hypotension', 'subarachnoid blockade (SAB', 'LUD group (received 15-30° LUD after SAB, n\xa0=\xa030) and non-LUD']","['cardiac output (CO) differences', 'maternal hemodynamic measures', 'CO', 'systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), CO, systemic vascular resistance (SVR), and left ventricular contractility index (dP/dT', 'maternal systolic hypotension']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",60.0,0.185135,"The LUD group had a lower incidence of maternal systolic hypotension at 5-min post-SAB (16.7% vs. 53.3% in non-LUD group, p = 0.003).
","[{'ForeName': 'Yanipan', 'Initials': 'Y', 'LastName': 'Chungsamarnyart', 'Affiliation': 'Department of Anesthesiology, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Petch', 'Initials': 'P', 'LastName': 'Wacharasint', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Carvalho', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, USA. Electronic address: bcarvalho@stanford.edu.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109796']
246,32315769,"Commentary on ""Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study"".",,2020,,[],['Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery'],[],[],"[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]",[],,0.158978,,"[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'von Bechtolsheim', 'Affiliation': 'Department of Visceral, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University Dresden, Fetscherstraße 74, 01307, Dresden, Germany. Electronic address: felix.bechtolsheim@uniklinikum-dresden.de.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Distler', 'Affiliation': 'Department of Visceral, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University Dresden, Fetscherstraße 74, 01307, Dresden, Germany.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.086']
247,32315954,"Screening for oral cancer: Future prospects, research and policy development for Asia.","Although the incidence of oral cavity cancer is high among low and middle income countries in Asia where the risk habits (tobacco smoking, tobacco chewing and betel quid use) are common, the benefits for introducing oral cancer screening for the whole population in these countries still remains controversial. It is disappointing, but not surprising that many of studies, without control arms, could not provide a clear answer as to whether screening is effective in reducing mortality or combating rising incidence trends. Only one Indian study that reported a randomized controlled trial (RCT) elucidated that mass screening for high risk groups could significantly reduce the cancer mortality or down-stage cancers detected by screening. Several professional organizations that considered any potential benefits of oral cancer screening remain unconvinced that the current knowledge on its natural history, available tests and interventions to treat potentially malignant disorders satisfy the desirable criteria to recommend organized screening for oral cancer. In this review we discuss advantages and disadvantages for oral cancer screening particularly with reference to high incidence countries in Asia. If screening is undertaken, we propose that it is targeted to high risk groups and to combine screening with education on risky life-styles so that overall incidence can be reduced in the future. Further research on increasing public awarenes and impact of professional education such as e-learning to reduce diagnostic delays, studies on the natural history of oral potentially malignant disorders and cancer, comprehensive tobacco and areca nut cessation programs, developing tools to identify high-risk individuals and high-risk lesions are proposed.",2020,"Several professional organizations that considered any potential benefits of oral cancer screening remain unconvinced that the current knowledge on its natural history, available tests and interventions to treat potentially malignant disorders satisfy the desirable criteria to recommend organized screening for oral cancer.",['oral cancer'],[],['cancer mortality'],"[{'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}]",[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0484795,"Several professional organizations that considered any potential benefits of oral cancer screening remain unconvinced that the current knowledge on its natural history, available tests and interventions to treat potentially malignant disorders satisfy the desirable criteria to recommend organized screening for oral cancer.","[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Nagao', 'Affiliation': 'Department of Maxillofacial Surgery School of Dentistry, Aichi Gakuin University, Nagoya, Japan. Electronic address: tnagao@dpc.agu.ac.jp.'}, {'ForeName': 'Saman', 'Initials': 'S', 'LastName': 'Warnakulasuriya', 'Affiliation': ""Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, WHO Collaborating Centre for Oral Cancer, UK.""}]",Oral oncology,['10.1016/j.oraloncology.2020.104632']
248,32330775,Treatment with intravenous immunoglobulin increases the level of small EVs in plasma of pregnant women with recurrent pregnancy loss.,"Extracellular vesicles (EVs), which are small cell-derived compartments, take part in numerous different physiological processes. The contents of EVs reveal the cell of origin and indicates pathophysiological states in different diseases. In pregnancy disorders, changes have been reported in the composition, bioactivity and concentration of placental and non-placental EVs. The purpose of this study was to monitor the effects on EVs in patients receiving intravenous immunoglobulin (IVIG) or placebo (albumin) treatment due to recurrent pregnancy loss (RPL). In a placebo-controlled trial study of IVIG treatment, plasma collected from 39 women with RPL were investigated using the Extracellular Vesicle Array (EV Array). Plasma was sampled consecutively (from gestational week (GW) 5) and the protein phenotypes of the smaller EVs (sEVs) were analyzed for the presence of 34 markers. The levels of sEVs or changes in their levels in early pregnancy were correlated with treatment. There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo. In conclusion, the treatment with high-doses of IVIG clearly boosted the production and release of sEVs to the circulation; however, the biological role of this boost remains to be clarified in further studies.",2020,There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo.,"['pregnant women with recurrent pregnancy loss', '39 women with RPL', 'patients receiving']","['placebo', 'intravenous immunoglobulin', 'intravenous immunoglobulin (IVIG) or placebo (albumin']","['levels of sEVs or changes in their levels in early pregnancy', 'level of small EVs', 'levels of sEVs']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0560135', 'cui_str': 'eV'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}]",39.0,0.0521941,There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo.,"[{'ForeName': 'Malene Møller', 'Initials': 'MM', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark. Electronic address: maljoe@rn.dk.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Bæk', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Sloth', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Varming', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Ole Bjarne', 'Initials': 'OB', 'LastName': 'Christiansen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Nadja Emilie', 'Initials': 'NE', 'LastName': 'Ditlevsen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark; School of Medicine and Health, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rajaratnam', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark; School of Medicine and Health, Aalborg University, Aalborg, Denmark.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103128']
249,32244170,Endogenous in-session cortisol during exposure therapy predicts symptom improvement: Preliminary results from a scopolamine-augmentation trial.,"The purpose of this study was to explore whether individual differences in glucocorticoid concentrations were associated with symptom improvement following exposure therapy for patients with social anxiety disorder. To do this, 60 participants with social anxiety disorder completed a randomized-controlled trial of exposure therapy, where participants were randomized to receive scopolamine-augmentation or placebo during their 7 exposure sessions. Scopolamine is an antimuscarinic which blocks the effects of acetylcholine and reduces autonomic arousal. During sessions 1, 4, 7, and during the post-treatment extinction assessment, participants provided up to 16 saliva samples (4 in each session). Pre-treatment, post-treatment, and at 1-month follow-up, participants completed the Liebowitz Social Anxiety Scale to monitor change in fear and avoidance symptoms. Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up. The association between elevated endogenous in-session cortisol and attenuated symptom change was not moderated by scopolamine treatment condition. Individuals with social anxiety disorder who have elevated neuroendocrine signaling may under-benefit from exposure therapy. This is the first study, to our knowledge, to examine whether endogenous in-session cortisol concentrations predict symptom changes following exposure therapy for the treatment of social anxiety disorder. More investigation of non-invasive and reliable biological markers that explain variability in responses to effective treatments are needed.",2020,Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up.,"['patients with social anxiety disorder', 'social anxiety disorder', '60 participants with social anxiety disorder', 'Individuals with social anxiety disorder who have elevated neuroendocrine signaling may under-benefit from exposure therapy']","['acetylcholine', 'Scopolamine', 'scopolamine', 'scopolamine-augmentation or placebo', 'exposure therapy']","['Liebowitz Social Anxiety Scale to monitor change in fear and avoidance symptoms', 'symptom improvement', 'autonomic arousal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",60.0,0.01704,Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up.,"[{'ForeName': 'Kate R', 'Initials': 'KR', 'LastName': 'Kuhlman', 'Affiliation': 'Department of Psychological Science, University of California Irvine, Irvine, CA, 92697, United States; Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States; Institute for Interdisciplinary Salivary Bioscience, University of California Irvine, Irvine, CA, 92697, United States. Electronic address: krkuhl@uci.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Treanor', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Imbriano', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, 11794, United States.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States; Department of Psychology, University of California Los Angeles, Los Angeles, CA, 90095, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104657']
250,32247156,Association between delirium prediction scores and days spent with delirium.,"PURPOSE


To determine the correlation and discriminative value of the E-PRE-DELIRIC and PRE-DELIRIC scores with delirium exposure to evaluate the prognostic value of both models.
METHODS


A secondary analysis of a randomized clinical trial enrolling 1506 delirium-free, critically ill adults with an anticipated ICU stay of ≥2 days. Days spent with delirium (≥1 positive CAM-ICU) or coma (≥1 RASS ≤-4) in the 28-days after ICU admission were calculated. Patients were categorized into four groups: no delirium, short-exposure (1 delirium day), moderate-exposure (2-5 delirium days), and long- exposure (≥6 delirium days) to determine the correlation and discriminative value of the E-PRE-DELIRIC and the PRE-DELIRIC with days spent with delirium.
RESULTS


The correlation between the overall E-PRE-DELIRIC and PRE-DELIRIC scores and days spent with delirium were: R = 0.08 (P = .005) and R = 0.26 (P < .001), respectively. The correlation between both prediction scores and days spent with coma or delirium were R = 0.21 (P < .0001) and R = 0.46 (P < .0001), respectively. The highest Area Under the Receiver Operating Characteristic for both E-PRE-DELIRIC [0.57 (95% CI:0.51-0.62)] and PRE-DELIRIC [0.58 (95% CI:0.53-0.62)] was found in the long delirium exposure group.
CONCLUSION


The E-PRE-DELIRIC and PRE-DELIRIC model each poorly correlate and discriminate with days spent with delirium in the 28 days after ICU admission.",2020,The correlation between both prediction scores and days spent with coma or delirium were R = 0.21,"['1506 delirium-free, critically ill adults with an anticipated ICU stay of ≥2\xa0days', 'Patients were categorized into four groups: no delirium, short-exposure (1 delirium day), moderate-exposure (2-5 delirium days), and long- exposure (≥6 delirium days) to determine the correlation and discriminative value of the E-PRE-DELIRIC and the PRE-DELIRIC with days spent with delirium']",[],"['overall E-PRE-DELIRIC and PRE-DELIRIC scores', 'prediction scores and days spent with coma or delirium']","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]",1506.0,0.138306,The correlation between both prediction scores and days spent with coma or delirium were R = 0.21,"[{'ForeName': 'Hidde', 'Initials': 'H', 'LastName': 'Heesakkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud university medical center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': 'School of Pharmacy, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Arjen J C', 'Initials': 'AJC', 'LastName': 'Slooter', 'Affiliation': 'Department of Intensive Care Medicine and UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, the Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van den Boogaard', 'Affiliation': 'Department of Intensive Care Medicine, Radboud university medical center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands. Electronic address: Mark.vandenBoogaard@radboudumc.nl.'}]",Journal of critical care,['10.1016/j.jcrc.2020.03.008']
251,32247219,Choosing endotracheal tube size in children: Which formula is best?,"OBJECTIVES


Various formulae have been suggested to calculate the appropriate sized endotracheal tube in children. The current study prospectively compares three commonly used formulae for selection of cuffed endotracheal tubes in children.
METHODS


Patients were randomized to one of three formulae (Duracher, Cole, or Khine) to determine the size of the cuffed endotracheal tube for endotracheal intubation. The fit of the tube was noted and intracuff pressure was measured using a manometer. The postoperative incidence of stridor, throat pain/soreness, and hoarseness was noted in the post-anesthesia care unit at 2, 4 and 24 h after the procedure.
RESULTS


The study cohort included 135 patients less than or equal to 8 years, equally divided into three groups based on age, weight, and gender. There was no difference in the intracuff pressure, the volume required to seal the airway, or the number of times in which the intracuff pressure was greater than or equal to 20 or 30 cm H 2 O among the three groups. Six tube changes were required in the Cole group while no tube changes were required in the Duracher group (p < 0.05). The postoperative incidence of adverse events (throat pain, hoarseness, and stridor) at 0-2 h, 2-4 h, and 24 h was higher in the Cole group when compared to the Duracher group.
CONCLUSION


When using an endotracheal tube with a polyurethane cuff, the Duracher formula provided the best estimate for choosing the correct size.",2020,"The postoperative incidence of adverse events (throat pain, hoarseness, and stridor) at 0-2 h, 2-4 h, and 24 h was higher in the Cole group when compared to the Duracher group.
","['Patients', 'children', '135 patients less than or equal to 8 years, equally divided into three groups based on age, weight, and gender']","['cuffed endotracheal tubes', 'cuffed endotracheal tube for endotracheal intubation', 'three formulae (Duracher, Cole, or Khine']","['postoperative incidence of stridor, throat pain/soreness, and hoarseness', 'intracuff pressure, the volume required to seal the airway, or the number of times in which the intracuff pressure', 'intracuff pressure', 'postoperative incidence of adverse events (throat pain, hoarseness, and stridor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C3809781', 'cui_str': 'Cole disease'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038450', 'cui_str': 'Stridor'}, {'cui': 'C0242429', 'cui_str': 'Pain in throat'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449809', 'cui_str': 'Number of times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",135.0,0.0226457,"The postoperative incidence of adverse events (throat pain, hoarseness, and stridor) at 0-2 h, 2-4 h, and 24 h was higher in the Cole group when compared to the Duracher group.
","[{'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'Manimalethu', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Krishna', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Shabana Z', 'Initials': 'SZ', 'LastName': 'Shafy', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA. Electronic address: shabana.shafy@nationwidechildrens.org.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Hakim', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tobias', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA; Department of Anesthesiology & Pain Medicine, The Ohio State University College of Medicine, Columbus, OH, USA.""}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110016']
252,32252004,Potential applications for rhIGF-I: Bone disease and IGFI.,"Growth hormone (GH) and insulin like growth factor-I (IGFI) are key bone trophic hormones, whose rising levels during puberty are critical for pubertal bone accrual. Conditions of GH deficiency and genetic resistance impact cortical and trabecular bone deleteriously with reduced estimates of bone strength. In humans, conditions of undernutrition (as in anorexia nervosa (AN), or subsequent to chronic illnesses) are associated with low IGF-I levels, which correlate with disease severity, and also with lower bone mineral density (BMD), impaired bone structure and lower strength estimates. In adolescents and adults with AN, studies have demonstrated a nutritionally acquired GH resistance with low IGF-I levels despite high concentrations of GH. IGF-I levels go up with increasing body weight, and are associated with rising levels of bone turnover markers. In short-term studies lasting 6-10 days, recombinant human IGF-I (rhIGF-I) administration in physiologic replacement doses normalized IGF-I levels and increased levels of bone formation markers in both adults and adolescents with AN. In a randomized controlled trial in adults with AN in which participants were randomized to one of four arms: (i) rhIGF-I with oral estrogen-progesterone (EP), (ii) rhIGF-I alone, (iii) EP alone, or (iv) neither for 9 months, a significant increase in bone formation markers was noted in the groups that received rhIGF-I, and a significant decrease in bone resorption markers in the groups that received EP. The group that received both rhIGF-I and EP had a significant increase in bone density at the spine and hip compared to the group that received neither. Side effects were minimal, with no documented fingerstick glucose of <50 mg/dl. These data thus suggest a potential role for rhIGF-I administration in optimizing bone accrual in states of undernutrition associated with low IGF-I.",2020,I and EP had a significant increase in bone density at the spine and hip compared to the group that received neither.,"['adults with AN in which participants', 'adults and adolescents with AN']","['recombinant human IGF-I (rhIGF-I) administration in physiologic replacement', 'rhIGF-I with oral estrogen-progesterone (EP), (ii) rhIGF-I alone, (iii) EP alone', 'rhIGF', 'Growth hormone (GH) and insulin like growth factor-I (IGFI']","['fingerstick glucose', 'bone formation markers', 'bone resorption markers', 'bone strength', 'bone density', 'levels of bone formation markers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0486261,I and EP had a significant increase in bone density at the spine and hip compared to the group that received neither.,"[{'ForeName': 'Marisol', 'Initials': 'M', 'LastName': 'Bahamonde', 'Affiliation': 'Department of Pediatrics, Universidad San Francisco de Quito (USFQ), Cumbayá, Ecuador.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Misra', 'Affiliation': 'Division of Pediatric Endocrinology, Massachusetts General Hospital for Children, USA; Neuroendocrine Unit, Massachusetts General Hospital, Boston, MA, USA. Electronic address: mmisra@mgh.harvard.edu.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101317']
253,32396668,Effectiveness of a short web-based film targeting parental oral health knowledge in a well-child care setting.,"Young children rely on their parents with respect to oral health routines. However, parental knowledge on this topic is often insufficient. Well-child care may be an excellent route to reach parents because almost all of them attend. To evaluate the effectiveness of an 8.5 min web-based film about oral health, provided by well-child care, a non-blinded quasi-experimental study was performed. Parents attending well-child care clinics in the Netherlands were assigned to an intervention (n = 88) or control group (n = 41). The control group received care as usual. We measured parental knowledge of oral health with a questionnaire (range of scores 1-12) before and directly after the intervention, and 6 months later, and assessed differences between the intervention and the control group. Parental oral health knowledge improved after watching the film: the intervention group's mean score of 11.1 (SD 1.3) was greater than the mean score of 7.1 (SD 2.0) of the control group (Cohen's d = 2.64). Scores remained higher in the intervention group 6 months after watching the film (mean 9.1, SD 1.3) than before (Cohen's d = 1.25). A web-based educational film delivered in a well-child care setting can be an effective way to address oral health and to improve parental knowledge.",2020,"Scores remained higher in the intervention group 6 months after watching the film (mean 9.1, SD 1.3) than before (Cohen's d = 1.25).",['Parents attending well-child care clinics in the Netherlands'],['short web-based film targeting parental oral health knowledge'],"['parental knowledge of oral health', 'Parental oral health knowledge']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0312641,"Scores remained higher in the intervention group 6 months after watching the film (mean 9.1, SD 1.3) than before (Cohen's d = 1.25).","[{'ForeName': 'Deborah Ashley', 'Initials': 'DA', 'LastName': 'Verlinden', 'Affiliation': 'Centre of Dentistry and Oral Hygiene, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Annemarie A', 'Initials': 'AA', 'LastName': 'Schuller', 'Affiliation': 'Centre of Dentistry and Oral Hygiene, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Gijsbert H W', 'Initials': 'GHW', 'LastName': 'Verrips', 'Affiliation': 'Centre of Dentistry and Oral Hygiene, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Sijmen A', 'Initials': 'SA', 'LastName': 'Reijneveld', 'Affiliation': 'Department of Child Health, Netherlands Organization for Applied Scientific Research TNO, Leiden, the Netherlands.'}]",European journal of oral sciences,['10.1111/eos.12700']
254,32334146,Impact of viewing body image health promotion videos in adult men and women: Comparison of narrative and informational approaches.,"Body dissatisfaction is a serious public health issue, however, low awareness of its seriousness, and stigma, may inhibit treatment seeking. Social marketing videos using narrative-entertainment or documentary-informational style approaches may enhance awareness but little research has evaluated their impact, particularly potentially harmful effects. The current study addressed this gap. Men (n = 226) and women (n = 229), were randomly allocated to view one of four videos; (1) Narrative, (2) Narrative plus persuasive appeal, (3) Informational, and (4) Informational plus persuasive appeal. Outcome variables were assessed before and after viewing. A time-by-video interaction indicated an increase in perception of the importance of body dissatisfaction as a public health problem following informational, but not narrative videos. Time by gender interactions showed that women, but not men, experienced increased body weight satisfaction and reduced intentions to engage in body-talk after video viewing. Time main effects revealed improvements in perceptions of the problematic nature of body dissatisfaction related behaviours, in shape and muscularity satisfaction, and reduced anxiety and intentions to use body-talk and appearance comparison. Findings suggest that social marketing can increase awareness of body dissatisfaction without inadvertently causing harm. Results from this study provide preliminary support for dissemination through social marketing.",2020,"Time main effects revealed improvements in perceptions of the problematic nature of body dissatisfaction related behaviours, in shape and muscularity satisfaction, and reduced anxiety and intentions to use body-talk and appearance comparison.","['adult men and women', 'Men (n\u202f=\u202f226) and women (n\u202f=\u202f229']","['Narrative plus persuasive appeal, (3) Informational, and (4) Informational plus persuasive appeal', 'social marketing', 'viewing body image health promotion videos']","['body weight satisfaction and reduced intentions to engage in body-talk', 'perceptions of the problematic nature of body dissatisfaction related behaviours, in shape and muscularity satisfaction, and reduced anxiety and intentions to use body-talk and appearance comparison', 'awareness of body dissatisfaction', 'perception of the importance of body dissatisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",,0.0312284,"Time main effects revealed improvements in perceptions of the problematic nature of body dissatisfaction related behaviours, in shape and muscularity satisfaction, and reduced anxiety and intentions to use body-talk and appearance comparison.","[{'ForeName': 'Siân A', 'Initials': 'SA', 'LastName': 'McLean', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Australia; Institute for Health and Sport, Victoria University, Melbourne, Australia. Electronic address: s.mclean@latrobe.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.04.001']
255,32335402,Testosterone concentrations and risk of cardiovascular events in androgen-deficient men with atherosclerotic cardiovascular disease.,"BACKGROUND


Whether androgen deficiency among men increases the risk of cardiovascular (CV) events or is merely a disease marker remains a subject of intense scientific interest.
OBJECTIVES


Among male subjects in the AIM-HIGH Trial with metabolic syndrome and low baseline levels of high-density lipoprotein (HDL)-cholesterol who were randomized to niacin or placebo plus simvastatin, we examined the relationship between low baseline testosterone (T) concentrations and subsequent CV outcomes during a mean 3-year follow-up.
METHODS


In this post hoc analysis of men with available baseline plasma T concentrations, we examined the relationship between clinical/demographic characteristics and T concentrations both as a continuous and dichotomous variable (<300 ng/dL [""low T""] vs. ≥300 ng/dL [""normal T""]) on rates of pre-specified CV outcomes, using Cox proportional hazards models.
RESULTS


Among 2118 male participants in whom T concentrations were measured, 643 (30%) had low T and 1475 had normal T concentrations at baseline. The low T group had higher rates of diabetes mellitus, hypertension, elevated body mass index, metabolic syndrome, higher blood glucose, hemoglobin A1c, and triglyceride levels, but lower levels of both low-density lipoprotein and HDL-cholesterol, and a lower rate of prior myocardial infarction (MI). Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively.
CONCLUSIONS


In this post hoc analysis, there was an association between low baseline testosterone concentrations and increased risk of subsequent CV events in androgen-deficient men with established CV disease and metabolic syndrome, particularly for the composite secondary endpoint of CHD death, MI, and stroke.
CONDENSED ABSTRACT


In this AIM-HIGH Trial post hoc analysis of 2118 men with metabolic syndrome and low HDL-cholesterol with available baseline plasma testosterone (T) samples, 643 males (30%) had low T (mean: 229 ng/dL) and 1475 (70%) had normal T (mean: 444 ng/dL) concentrations. The ""low T"" group had a 24% higher risk of the primary 5-component endpoint (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07). There was also a 31% higher risk of the secondary composite endpoint: coronary heart disease death, myocardial infarction, and stroke (11.8% vs. 8.2%, final adjusted HR 1.37, P = .04) in the low vs. normal T group, respectively.",2020,"Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively.
","['2118 male participants in whom T concentrations were measured, 643 (30%) had low T and 1475 had normal T concentrations at baseline', '2118 men with metabolic syndrome and low HDL-cholesterol with available baseline plasma testosterone (T) samples, 643 males (30%) had low T (mean', 'androgen-deficient men with atherosclerotic cardiovascular disease', 'male subjects in the AIM-HIGH Trial with metabolic syndrome and low baseline levels of high-density lipoprotein (HDL)-cholesterol who were randomized to']",['niacin or placebo plus simvastatin'],"['low baseline testosterone concentrations and increased risk of subsequent CV events', 'CHD death, MI, and stroke composite endpoint', 'Testosterone concentrations and risk of cardiovascular events', 'coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization', 'secondary composite endpoint: coronary heart disease death, myocardial infarction, and stroke', 'low baseline testosterone (T) concentrations and subsequent CV outcomes', 'rates of diabetes mellitus, hypertension, elevated body mass index, metabolic syndrome, higher blood glucose, hemoglobin A1c, and triglyceride levels, but lower levels of both low-density lipoprotein and HDL-cholesterol, and a lower rate of prior myocardial infarction (MI']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0857717', 'cui_str': 'Plasma testosterone'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]","[{'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0007794', 'cui_str': 'Cerebral revascularisation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}]",2118.0,0.309705,"Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively.
","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': 'VA Boston Healthcare System, Boston University School of Medicine, Boston, MA. Electronic address: william.boden@va.gov.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Miller', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McBride', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Snabes', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'McGovern', 'Affiliation': 'VA Boston Healthcare System, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': 'National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': 'Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta.'}, {'ForeName': 'Moti', 'Initials': 'M', 'LastName': 'Kashyap', 'Affiliation': 'Long Beach VA Healthcare System, Los Angeles, CA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Probstfield', 'Affiliation': 'University of Washington, Seattle, WA.'}]",American heart journal,['10.1016/j.ahj.2020.03.016']
256,32280035,Adolescent cognitive control and mediofrontal theta oscillations are disrupted by neglect: Associations with transdiagnostic risk for psychopathology in a randomized controlled trial.,"Children that have experienced psychosocial neglect display impairments in self-monitoring and controlling their behavior (cognitive control) and are at broad, transdiagnostic risk for psychopathology. However, the neural underpinnings of such effects remain unclear. Event-related mediofrontal theta oscillations reflect a neural process supporting cognitive control that may relate to transdiagnostic psychopathology risk. Recent work demonstrates reduced mediofrontal theta in rodent models of neglect; however, similar findings have not been reported in humans. Here, 136 children reared in Romanian institutions were randomly assigned to either a high-quality foster care intervention and placed with families or remained in institutions; 72 never-institutionalized children served as a comparison group. The intervention ended at 54 months; event-related mediofrontal theta and psychopathology were assessed at 12- and 16-year follow-up assessments. Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for. Earlier placement into foster care yielded greater mediofrontal activity by age 16. Moreover, foster care placement was associated with the developmental trajectory of mediofrontal theta across the adolescent period (ages 12-16), which was, in turn, associated with greater reductions in transdiagnostic risk across this same period. These data reflect the first experimental evidence that the development of mediofrontal theta is impacted by removal from situations of neglect in humans, and further characterizes the importance of studying developmental change in mediofrontal theta during the adolescent period.",2020,"Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for.",['136 children reared in Romanian institutions'],['high-quality foster care intervention and placed with families or remained in institutions; 72 never-institutionalized children served as a comparison group'],"['Adolescent cognitive control and mediofrontal theta oscillations', 'transdiagnostic risk', 'mediofrontal activity']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",136.0,0.0417503,"Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Buzzell', 'Affiliation': 'University of Maryland, College Park, MD, United States. Electronic address: gbuzzell@umd.edu.'}, {'ForeName': 'Sonya V', 'Initials': 'SV', 'LastName': 'Troller-Renfree', 'Affiliation': 'Teachers College, Columbia University, NY, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Debnath', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Morales', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Bowers', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA, United States.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Harvard Medical School, Boston, MA, United States; Boston Children's Hospital, Boston, MA, United States; Harvard Graduate School of Education, Boston, MA, United States.""}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}]",Developmental cognitive neuroscience,['10.1016/j.dcn.2020.100777']
257,32299024,"A double-blind, randomized controlled trial of duloxetine for pain in Parkinson's disease.","BACKGROUND


Duloxetine proved effective for treating pain in people with Parkinson's disease in a single-arm, open-label study.
OBJECTIVE


To evaluate the efficacy of duloxetine in a double-blind, randomized, placebo-controlled trial.
METHODS


We randomly assigned 46 patients with Parkinson's disease with pain to either the duloxetine 40 mg/day arm or the placebo arm. After 10 weeks, we tested the change from baseline in 24-hour average pain severity measured by a visual analogue scale.
RESULTS


We could not confirm the effect of duloxetine on pain. Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
CONCLUSIONS


The study failed to provide evidence for the use of duloxetine for treating pain in people with Parkinson's disease.",2020,"Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
","[""people with Parkinson's disease in a single-arm, open-label study"", ""pain in Parkinson's disease"", ""people with Parkinson's disease"", ""46 patients with Parkinson's disease with pain to either the""]","['duloxetine', 'placebo', 'Duloxetine', 'duloxetine 40\xa0mg/day arm or the placebo']","['24-hour average pain severity measured by a visual analogue scale', ""Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39"", 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1576942', 'cui_str': 'duloxetine 40 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",46.0,0.692206,"Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Iwaki', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Laboratory of Neurogenetics, National Institute on Aging, National Institute of Health, MD, USA; Data Tecnica International, MD, USA.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Ando', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tada', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Neurology, National Center Hospital of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Tsujii', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamanishi', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Miyaue', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Yabe', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nagai', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Imabari Hospital, Ehime, Japan. Electronic address: nomoto1492@nifty.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116833']
258,32302788,Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF): A cluster randomized trial of a computerized clinical decision support tool.,"BACKGROUND


Clinical decision support (CDS) tools designed to digest, filter, organize, and present health data are becoming essential in providing clinical and cost-effective care. Many are not rigorously evaluated for benefit before implementation. We assessed whether computerized CDS for primary care providers would improve atrial fibrillation (AF) management and outcomes as compared to usual care.
METHODS


Overall, 203 primary care providers were recruited, randomized, and then cluster stratified by location (urban, rural) to usual care (n = 99) or CDS (n = 104). Providers recruited 1,145 adult patients with AF to participate. The intervention was access to an evidenced-based, point-of-care computerized CDS designed to support guideline-based AF management. The primary efficacy outcome was a composite of unplanned cardiovascular hospitalizations and AF-related emergency department visits; the primary safety outcome was major bleeding, both over 1 year. Patients were the units of intention-to-treat analysis.
RESULTS


No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months.
CONCLUSIONS


IMPACT-AF rigorously assessed a CDS tool in a highly representative sample of primary care providers and their patients; however, no impact on outcomes was observed. Considering the proliferating use of CDS applications, this study highlights the need for efficacy assessments prior to adoption and clinical implementation.",2020,"No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months.
","['1,145 adult patients with AF to participate', 'Atrial Fibrillation (IMPACT-AF', '203 primary care providers were recruited, randomized, and then cluster stratified by location (urban, rural) to usual care (n\u202f=\u202f99) or CDS (n\u202f=\u202f104']",['computerized CDS'],"['atrial fibrillation (AF) management and outcomes', 'composite of unplanned cardiovascular hospitalizations and AF-related emergency department visits; the primary safety outcome was major bleeding, both over 1 year', 'primary efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1145.0,0.0610574,"No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months.
","[{'ForeName': 'Jafna L', 'Initials': 'JL', 'LastName': 'Cox', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Department of Community Health and Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada; Heart and Stroke Foundation of Nova Scotia Endowed Chair in Cardiovascular Outcomes Research, Halifax, Nova Scotia, Canada. Electronic address: jafna.cox@dal.ca.'}, {'ForeName': 'Ratika', 'Initials': 'R', 'LastName': 'Parkash', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Foster', 'Affiliation': ""Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Biostatistics Unit, St Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'MacKillop', 'Affiliation': 'Sydney Primary Care Medical Clinic, Sydney, Nova Scotia, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ciaccia', 'Affiliation': 'Bayer Inc, Mississauga, Ontario, Canada.'}, {'ForeName': 'Shurjeel H', 'Initials': 'SH', 'LastName': 'Choudhri', 'Affiliation': 'Bayer Inc, Mississauga, Ontario, Canada.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Hamilton', 'Affiliation': 'QEII Health Sciences Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Nemis-White', 'Affiliation': 'Strive Health Management Consulting Ltd, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Departments of Anesthesia/Pediatrics, McMaster University, Hamilton, Ontario, Canada; Biostatistics Unit, Centre for Evaluation of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute (PHRI), Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.02.019']
259,32305825,Effect of pregnancy and exclusive breastfeeding on multiple sclerosis relapse rate and degree of disability within two years after delivery.,"OBJECTIVES


Pregnancy and lactation are important issues for women with multiple sclerosis (MS). The purpose of this study was to investigate the effect of pregnancy and exclusive breastfeeding on the rate of relapse and degree of disability within two years after delivery among patients with relapsing remitting multiple sclerosis (RRMS).
PATIENTS AND METHODS


30 pregnant women with RRMS who had exclusive breastfeeding for 4 months were compared with 67 non-pregnant women with RRMS between 2012 and 2017. Each patient was examined every three months for 33 months. In the study group, patients were examined at the beginning of pregnancy, and then every three months till 24th months after delivery.
RESULTS


In the study group, Expanded Disability Status Scale (EDSS) during the third trimester of pregnancy, between four to nine month after delivery, and the last 6 months of the study were significantly lower than the control group (p < 0.05). At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05). Also, EDSS during the second and third trimesters of pregnancy were significantly lower than the EDSS before pregnancy (p < 0.05). The mean number of relapses in the second and third trimesters of pregnancy, between four to six months after delivery, and the total number of relapses were significantly lower than the control group.
CONCLUSION


Pregnancy and exclusive breastfeeding can have a positive effect in reducing relapse rate and disability. This effect will continue until the 24th month after childbirth.",2020,"At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05).","['patients with relapsing remitting multiple sclerosis (RRMS', '30 pregnant women with RRMS who had exclusive breastfeeding for 4 months were compared with 67 non-pregnant women with RRMS between 2012 and 2017', 'women with multiple sclerosis (MS']",['pregnancy and exclusive breastfeeding'],"['total number of relapses', 'Expanded Disability Status Scale (EDSS', 'relapse rate and disability', 'mean EDSS', 'multiple sclerosis relapse rate and degree of disability', 'rate of relapse and degree of disability', 'mean number of relapses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.0139494,"At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05).","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Ghiasian', 'Affiliation': 'Hamedan University of Medical Sciences, Hamedan, Iran.'}, {'ForeName': 'Mohaddeseh', 'Initials': 'M', 'LastName': 'Nouri', 'Affiliation': 'Hamedan University of Medical Sciences, Hamedan, Iran.'}, {'ForeName': 'Abdorreza Naser', 'Initials': 'AN', 'LastName': 'Moghadasi', 'Affiliation': 'Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Ghaffari', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: m.ghaffari@sbmu.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105829']
260,32311521,"A Commentary on the article: Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study, Int J Surg. 2020 Mar 17. pii: S1743-9191(20)30231-4. doi: 10.1016/j.ijsu.2020.03.019.",,2020,,['pii'],['fluorescent imaging during laparoscopic surgery'],['peritoneal perfusion'],"[{'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}]","[{'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",,0.0758544,,"[{'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Karimian', 'Affiliation': 'Tehran University of Medical Sciences-TUMS, Iran. Electronic address: faramarz.karimian@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.074']
261,32315958,"Effects of oral butyrate and inulin supplementation on inflammation-induced pyroptosis pathway in type 2 diabetes: A randomized, double-blind, placebo-controlled trial.","PURPOSE


Pyroptosis, a form of inflammatory programmed cell death, is activated in diabetic patients. This study was conducted to investigate the effects of daily consumption of sodium butyrate (NaBut) and high-performance (HP) inulin supplementation, individually or in combination, on the expression of pyroptosis-related genes, microRNA (miR) 146a-5p, miR-9-5p and biomarkers of oxidative stress in patients with type 2 diabetes (T2DM).
METHODS


In this study, we conducted a randomized, double-blinded, placebo-controlled clinical involving sixty patients with type 2 diabetes. Participants received 600 mg/d of NaBut (group A), 10 g/d of HP inulin (group B), 600 mg/d of NaBut + 10 g/d of HP inulin (group C) or placebo (group D) for 45 consecutive days. We assessed the pyroptosis-related genes mRNA expression in peripheral blood mononuclear cells (PBMCs), as well as the plasmatic levels of miR-146a and miR-9 before and after the intervention. Moreover, blood samples of the patients at baseline and following the intervention were tested for total antioxidant capacity (TAC), superoxide dismutase (SOD) and catalase levels using enzyme-linked immunosorbent assay (ELISA). This study was registered on the Iranian Registry of Clinical Trials website (identifier: IRCT201605262017N29; https://www.irct.ir/).
RESULTS


Following butyrate supplementation, the relative expression levels of TLR2/4, NF-κB1, Caspase-1, NLRP3, IL-1β & IL-18 were significantly downregulated (p < 0.05). Furthermore, butyrate and concomitant use of butyrate and inulin caused a significant increase in the fold change of miR-146a and miR-9 compared with the placebo group (p < 0.05). Interestingly, the changes in total antioxidant capacity (p = 0.047) and superoxide dismutase (p = 0.006) were significantly increased after butyrate and concomitant use of butyrate and inulin supplement, respectively.
CONCLUSION


In summary, the change in expression level of miR-146a-5p and miR-9-5p due to butyrate supplementation may have a pivotal role in alleviating of diabetes via inhibiting pyroptosis by targeting TLR2 and NF-κB1. These microRNAs might be considered as potential therapeutic targets in the treatment of type 2 diabetes but further researches is required to prove the link.",2020,"Interestingly, the changes in total antioxidant capacity (p = 0.047) and superoxide dismutase (p = 0.006) were significantly increased after butyrate and concomitant use of butyrate and inulin supplement, respectively.
","['type 2 diabetes', 'sixty patients with type 2 diabetes', 'patients with type 2 diabetes (T2DM', 'diabetic patients']","['oral butyrate and inulin supplementation', 'placebo', '600\xa0mg/d of NaBut', 'NaBut\xa0+\xa010\xa0g/d of HP inulin', 'sodium butyrate (NaBut) and high-performance (HP) inulin supplementation', 'HP inulin']","['total antioxidant capacity', 'relative expression levels of TLR2/4, NF-κB1, Caspase-1, NLRP3, IL-1β & IL-18', 'expression of pyroptosis-related genes, microRNA (miR) 146a-5p, miR-9-5p and biomarkers of oxidative stress', 'fold change of miR-146a and miR-9', 'blood samples', 'superoxide dismutase', 'total antioxidant capacity (TAC), superoxide dismutase (SOD) and catalase levels using enzyme-linked immunosorbent assay (ELISA']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0142812', 'cui_str': 'Butyric Acid, Sodium Salt'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0534519', 'cui_str': 'Caspase-1'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C2610960', 'cui_str': 'Caspase-1 Dependent Cell Death'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C3884166', 'cui_str': 'MIRN9 microRNA, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}]",60.0,0.227835,"Interestingly, the changes in total antioxidant capacity (p = 0.047) and superoxide dismutase (p = 0.006) were significantly increased after butyrate and concomitant use of butyrate and inulin supplement, respectively.
","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Roshanravan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Naimeh Mesri', 'Initials': 'NM', 'LastName': 'Alamdari', 'Affiliation': 'Students Research Committee, School of Health, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Mohammad Asghari', 'Initials': 'MA', 'LastName': 'Jafarabadi', 'Affiliation': 'Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Cancer and Inflammation Research, Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark; Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Bahadir Rostamzadeh', 'Initials': 'BR', 'LastName': 'Shabestari', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Nasirzadeh', 'Affiliation': 'School of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': 'Stem Cell And Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Mansoori', 'Affiliation': 'Department of Cancer and Inflammation Research, Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark; Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Moloud', 'Initials': 'M', 'LastName': 'Akbarzadeh', 'Affiliation': 'Stem Cell And Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Abed', 'Initials': 'A', 'LastName': 'Ghavami', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Samad', 'Initials': 'S', 'LastName': 'Ghaffari', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: ghafaris@gmail.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: ostadrahimi@tbzmed.ac.ir.'}]",Cytokine,['10.1016/j.cyto.2020.155101']
262,32315965,Baduanjin mind-body exercise improves logical memory in long-term hospitalized patients with schizophrenia: A randomized controlled trial.,"Neurocognitive impairment is one of the core symptoms in schizophrenia and poses a great challenge to effective treatment. Sixty-one long-term hospitalized patients with schizophrenia were recruited and randomly assigned to two groups: Baduanjin exercise and brisk walking. Patients in the Baduanjin group received 24 weeks of Baduanjin training (5 days/week, 40 min/day), while patients in the brisk walking group received 24 weeks of brisk walking (5 days/week, 40 min/day). Scores on the Wechsler Memory Scale, Digit Symbol Substitution Test (DSST), and the positive and negative syndrome scale were used to evaluate the logical memory (LM), processing speed, and clinical symptoms of all participants, while the score of Trail Making Test-A (TMT-A) was applied to assess the visual attention and graphomotor speed, at baseline and the 16th week and 24th week of intervention. The one-way repeated measures analysis of variance (ANOVA) was used to test the differences in neurocognitive changes between the two groups. Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328). A significant effect of time was also detected in the LM immediate (F=10.24, p = 0.000) and LM delayed (F=4.93, p = 0.009) scores and in the completion time of the TMT-A (F=33.10, p = 0.000), but not in the DSST scores (F=2.12, p = 0.122). Baduanjin exercise could improve logical memory in the long-term hospitalized patients with schizophrenia.",2020,"Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328).","['long-term hospitalized patients with schizophrenia', 'hospitalized patients with schizophrenia', 'Sixty-one long-term hospitalized patients with schizophrenia']","['Baduanjin exercise', 'Baduanjin training', 'brisk walking group received 24 weeks of brisk walking', 'Baduanjin exercise and brisk walking', 'Baduanjin mind-body exercise']","['LM immediate', 'logical memory (LM), processing speed, and clinical symptoms', 'neurocognitive changes', 'LM delayed', 'logical memory', 'visual attention and graphomotor speed', 'completion time of the TMT-A', 'Wechsler Memory Scale, Digit Symbol Substitution Test (DSST), and the positive and negative syndrome scale', 'DSST scores']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C4517832', 'cui_str': '61'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.0321369,"Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328).","[{'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Mental Health Center and Psychiatric Laboratory, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China; The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China. Electronic address: limingli0517@qq.com.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Yusubujiang', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China. Electronic address: 577827619@qq.com.""}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102046']
263,32320843,"Brief cessation advice, nicotine replacement therapy sampling and active referral (BANSAR) for smoking expectant fathers: Study protocol for a multicentre, pragmatic randomised controlled trial.","BACKGROUND


Pregnancy presents a teachable moment to engage male smokers whose partners are pregnant in smoking cessation. Evidence on how to approach and help these smokers quit smoking in antenatal settings has remained scarce. This paper presents the rationale and study design of a trial which aims to evaluate the effectiveness of a brief intervention model for promoting smoking cessation in expectant fathers.
METHODS


BANSAR is a pragmatic randomised controlled trial conducted in antenatal clinic in seven public hospitals in Hong Kong, China. An estimated 1148 fathers who smoke at least one cigarette daily and whose partners are pregnant and non-smoking will be randomised (1:1) to receive brief advice combined with 1-week sample of nicotine replacement therapy (NRT) and active referral to smoking cessation services, or brief advice only (usual care). Outcome will be assessed at 3 and 6 months after treatment initiation. The primary outcome is carbon monoxide-verified (<4 part per million) abstinence at 6 months post-treatment initiation. Secondary outcomes include self-reported 7-day point-prevalence abstinence and 24-week continuous abstinence, use of smoking cessation service and NRT and quit attempt, and smoking reduction, change in nicotine dependence and intention to quit in continuing smokers.
COMMENT


This trial will provide real-world evidence on the effectiveness of a combined brief intervention model for smoking cessation in expectant fathers, an understudied population. The findings may be particularly relevant to low and middle-income countries, where male-to-female smoking ratios and birth rates tend to be higher than higher-income countries.
TRIAL REGISTRATION


ClinicalTrials.gov, number NCT03671707.",2020,"This trial will provide real-world evidence on the effectiveness of a combined brief intervention model for smoking cessation in expectant fathers, an understudied population.","['1148 fathers who smoke at least one cigarette daily and whose partners are pregnant and non-smoking', 'smoking expectant fathers', 'antenatal clinic in seven public hospitals in Hong Kong, China', 'expectant fathers']","['nicotine replacement therapy sampling and active referral (BANSAR', 'brief advice combined with 1-week sample of nicotine replacement therapy (NRT) and active referral to smoking cessation services, or brief advice only (usual care']","['carbon monoxide-verified (<4 part per million) abstinence', 'self-reported 7-day point-prevalence abstinence and 24-week continuous abstinence, use of smoking cessation service and NRT and quit attempt, and smoking reduction, change in nicotine dependence and intention to quit in continuing smokers']","[{'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",,0.144204,"This trial will provide real-world evidence on the effectiveness of a combined brief intervention model for smoking cessation in expectant fathers, an understudied population.","[{'ForeName': 'Tzu Tsun', 'Initials': 'TT', 'LastName': 'Luk', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Chi Ju', 'Initials': 'CJ', 'LastName': 'Hsieh', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Wing-Cheong', 'Initials': 'WC', 'LastName': 'Leung', 'Affiliation': 'Department of Obstetrics & Gynecology, Kwong Wah Hospital, Hong Kong.'}, {'ForeName': 'Kwok-Yin', 'Initials': 'KY', 'LastName': 'Leung', 'Affiliation': 'Department of Obstetrics & Gynecology, Queen Elizabeth Hospital, Hong Kong.'}, {'ForeName': 'Ka Wang', 'Initials': 'KW', 'LastName': 'Cheung', 'Affiliation': 'Department of Obstetrics & Gynecology, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Kwa', 'Affiliation': 'Department of Obstetrics & Gynecology, United Christian Hospital, Hong Kong.'}, {'ForeName': 'Kar-Hung', 'Initials': 'KH', 'LastName': 'Siong', 'Affiliation': 'Department of Obstetrics & Gynecology, Tuen Mun Hospital, Hong Kong.'}, {'ForeName': 'Kwok-Keung', 'Initials': 'KK', 'LastName': 'Tang', 'Affiliation': 'Department of Obstetrics & Gynecology, Pamela Youde Nethersole Eastern Hospital, Hong Kong.'}, {'ForeName': 'Kai-Wan', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics & Gynecology, Princess Margaret Hospital, Hong Kong.'}, {'ForeName': 'William Ho-Cheung', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong. Electronic address: mpwang@hku.hk.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106006']
264,32320894,Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracic Surgery Lobectomy.,"BACKGROUND


A narrow-profile powered vascular stapler (PVS) was developed to provide superior access and precise staple placement in thoracic procedures. The objective of this study was to determine if the PVS would yield an equivalent rate of hemostatic interventions compared with standard of care (SOC) staplers in video-assisted thoracoscopic surgery lobectomy.
MATERIALS AND METHODS


A randomized, controlled, multicenter study was conducted comparing PVS with SOC staplers in lobectomies performed for non-small cell lung cancer. The primary performance endpoint was the incidence of intraoperative hemostatic interventions, and the primary safety endpoint was the frequency of postoperative bleeding-related interventions.
RESULTS


A total of 98 subjects participated in the SOC group and 103 in the PVS group. Rates of intraoperative hemostatic interventions were 5.3% and 8.3% for the SOC and PVS groups, respectively. These rates were not statistically different (P = 0.137), although the upper bound of the 95% confidence interval for the difference in intervention rates between PVC and SOC exceeded a predefined 3% criterion for equivalence. Simple compressions were performed more frequently in the PVS subjects, which accounted for the higher intervention rate in this group. Postoperative interventions for bleeding were required in one SOC subject (1.0%) and one subject from the PVS group (0.9%). Procedure-related adverse events occurred in 21 (21.9%) SOC subjects and 23 (21.9%) PVS subjects, with no adverse events related to use of the study devices.
CONCLUSIONS


The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.",2020,The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.,"['98 subjects participated in the SOC group and 103 in the PVS group', 'non-small cell lung cancer']","['Powered Vascular Stapler in Video-Assisted Thoracic Surgery Lobectomy', 'standard of care (SOC) staplers in video-assisted thoracoscopic surgery lobectomy', 'SOC staplers', 'vascular stapler (PVS', 'PVS with SOC staplers']","['frequency of postoperative bleeding-related interventions', 'Procedure-related adverse events', 'incidence of intraoperative hemostatic interventions', 'Rates of intraoperative hemostatic interventions']","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C4520228', 'cui_str': 'Thoracoscopic surgical lobectomy using video-assisted guidance'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}]",98.0,0.124483,The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.,"[{'ForeName': 'Laureano', 'Initials': 'L', 'LastName': 'Molins', 'Affiliation': 'Department of Thoracic Surgery, Barcelona University, Barcelona, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lanuti', 'Affiliation': 'Division of Thoracic Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Force', 'Affiliation': 'Department of Surgery, The Emory Clinic, Atlanta, Georgia, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Woolley', 'Affiliation': 'Consultant Thoracic Surgeon, Liverpool Heart & Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Krantz', 'Affiliation': 'Division of Thoracic Surgery, Northshore University Health System, Evanston, Illinois, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Creedon', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Schwiers', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Singleton', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA. Electronic address: dsingl12@its.jnj.com.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Waggoner', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Fryrear', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Licht', 'Affiliation': 'Department of Cardiothoracic Surgery, Odense University Hospital, Odense, Denmark.'}]",The Journal of surgical research,['10.1016/j.jss.2020.03.023']
265,32330764,Preventing college student nonmedical prescription stimulant use: Development of vested interest theory-based persuasive messages.,"Vested interest theory (VIT) predicts that perceived importance and hedonic relevance of an expected behavioral outcome affects attitude-behavior consistency. Applied to college students' nonmedical use of prescription stimulants (NUPS), the theory posits that persuasive information that weakens vested perceptions regarding assumed advantages of stimulant misuse will reduce usage intentions. The current study developed and experimentally assessed persuasive messages that targeted perceptions of vested interest (VI), and examined if message effectiveness varied as a function of users' risk status. Appeals that focused on the physical harms of misuse served as the comparison condition. College student participants (N = 282) were randomly assigned to one of four message conditions. To examine group differences, data were analyzed in a 2 (VIT-based message: yes, no) × 2 (Physical harms emphasized: yes, no) × 3 (User status: resolute, vulnerable, user) between-subjects factorial design. Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005. In vulnerable nonusers, these messages also decreased NUPS intentions p = .006. The effect of exposure to the physical harm communication was not significant. Findings support the potential of VIT-guided messages in NUPS prevention, and the lack of effect of messages focused on physical consequences of misuse.",2020,Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005.,"['College student participants (N\xa0=\xa0282', 'college students']","['Vested interest theory (VIT', 'NUPS', 'nonmedical use of prescription stimulants (NUPS']",['cognitive functioning'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517681', 'cui_str': '282'}]","[{'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",282.0,0.0167375,Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005.,"[{'ForeName': 'Candice D', 'Initials': 'CD', 'LastName': 'Donaldson', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: Candice.Donaldson@cgu.edu.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Siegel', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: Jason.Siegel@cgu.edu.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Crano', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: William.Crano@cgu.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106440']
266,32179428,The effects of repeated transcranial direct current stimulation on sleep quality and depression symptoms in patients with major depression and insomnia.,"IMPORTANCE


Although several strategies using transcranial direct current stimulation (tDCS) have been investigated to treat major depressive disorder (MDD), the efficacy of this treatment for patients with MDD who also have insomnia is unclear.
OBJECTIVE


To observe the effects of tDCS on sleep quality and depressive symptoms in patients with MDD who have insomnia.
METHODS


We conducted a randomized, double-blinded study involving adults with major depression and insomnia. We randomly assigned patients to either add tDCS or to sham tDCS to their regular treatment. After randomization, we treated a total of 90 patients at the Kangning Hospital, Ningbo, China. We allocated 47 patients to the tDCS group and 43 to the sham tDCS group. The tDCS treatment procedure included 20 sessions of 2-mA stimulation of the dorsolateral prefrontal cortex (DLPFC) for 30 min, which was followed by four weekly treatments. The anode and cathode electrodes were placed on the left and right DLPFC, respectively. We recorded the Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), Pittsburgh Sleep Quality Inventory (PSQI), and Polysomnography (PSG) at Day 1 and Day 28.
RESULTS


Compared with the sham tDCS group, the active tDCS group showed improved total scores of SAS and SDS. PSQI total score and all PSQI sub-divisions, except for ""sleep duration and sleep efficiency,"" significantly improved after treatment. We also observed that tDCS affected sleep architecture, by increasing total sleep time and improving sleep efficiency through PSG.
CONCLUSIONS


Our study demonstrated the effect of tDCS on sleep quality and depressive symptoms in patients with MDD and insomnia. These results suggested that tDCS stimulation not only improved symptoms of depression and anxiety but also had a positive effect on sleep quality in patients with MDD. For patients with depression and insomnia, tDCS stimulation could be a good supplement to drugs.",2020,"PSQI total score and all PSQI sub-divisions, except for ""sleep duration and sleep efficiency,"" significantly improved after treatment.","['90 patients at the Kangning Hospital, Ningbo, China', 'patients with MDD', 'patients with MDD and insomnia', 'patients with major depression and insomnia', '47 patients to the tDCS group and 43 to the sham tDCS group', 'patients with MDD who have insomnia', 'adults with major depression and insomnia']","['tDCS', 'transcranial direct current stimulation (tDCS', 'sham tDCS', 'transcranial direct current stimulation', 'tDCS or to sham tDCS']","['total scores of SAS and SDS', 'sleep quality and depression symptoms', 'PSQI total score and all PSQI sub-divisions, except for ""sleep duration and sleep efficiency', 'sleep quality', 'Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), Pittsburgh Sleep Quality Inventory (PSQI), and Polysomnography (PSG', 'symptoms of depression and anxiety', 'total sleep time', 'sleep quality and depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",90.0,0.0527442,"PSQI total score and all PSQI sub-divisions, except for ""sleep duration and sleep efficiency,"" significantly improved after treatment.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Haihang', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Zhiwang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China. Electronic address: ytf0707@126.com.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China. Electronic address: wyzhouds@sina.com.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.003']
267,30501388,The Addition of Glenohumeral Adductor Coactivation to a Rotator Cuff Exercise Program for Rotator Cuff Tendinopathy: A Single-Blind Randomized Controlled Trial.,"BACKGROUND


Treatments for rotator cuff tendinopathy include rotator cuff muscle strengthening to promote better muscle recruitment in order to minimize subacromial narrowing during active movement. Glenohumeral adductor recruitment has also been shown to prevent such narrowing in asymptomatic individuals; therefore, adding glenohumeral adductor coactivation during rotator cuff strengthening could enhance the efficacy of rotator cuff strengthening. However, no study has explored its benefits.
OBJECTIVES


To compare the short-term efficacy of adding glenohumeral adductor coactivation to a rotator cuff-strengthening program to improve function, reduce symptoms, and increase acromiohumeral distance in adults with rotator cuff tendinopathy.
METHODS


In this single-blind randomized controlled trial, 42 participants with rotator cuff tendinopathy were randomly assigned to 2 groups, one that received strengthening of the scapular and rotator cuff muscles or one that received rotator cuff strengthening plus coactivation with pectoralis major and latissimus dorsi recruitment. The daily programs were performed at home for 6 weeks, with supervised training and follow-up sessions. Functional limitations/symptoms (Disabilities of the Arm, Shoulder and Hand [DASH] questionnaire as the primary outcome, and the Western Ontario Rotator Cuff index), pain (visual analog scale), and acromiohumeral distance were measured at baseline, 3 weeks, and 6 weeks. Data were analyzed using a mixed-model analysis of variance.
RESULTS


No significant group-by-time interaction was observed for the Disabilities of the Arm, Shoulder and Hand questionnaire, Western Ontario Rotator Cuff index, visual analog scale, and acromiohumeral distance (P≥.055). Significant time effects were obtained for the Western Ontario Rotator Cuff index and visual analog scale for pain with movement (P<.001).
CONCLUSION


The present findings show that adding glenohumeral adductor coactivation to a rotator cuff-strengthening program does not result in improved short-term efficacy in any of the measured outcomes. This study was registered with ClinicalTrials.gov (NCT02837848).
LEVEL OF EVIDENCE


Therapy, level 1b. J Orthop Sports Phys Ther 2019;49(3):126-135. Epub 30 Nov 2018. doi:10.2519/jospt.2019.8240.",2019,"No significant group-by-time interaction was observed for the Disabilities of the Arm, Shoulder and Hand questionnaire, Western Ontario Rotator Cuff index, visual analog scale, and acromiohumeral distance (P≥.055).","['adults with rotator cuff tendinopathy', 'Rotator Cuff Tendinopathy', '42 participants with rotator cuff tendinopathy']","['Glenohumeral Adductor Coactivation to a Rotator Cuff Exercise Program', 'glenohumeral adductor coactivation to a rotator cuff-strengthening program', 'strengthening of the scapular and rotator cuff muscles or one that received rotator cuff strengthening plus coactivation with pectoralis major and latissimus dorsi recruitment']","['Functional limitations/symptoms (Disabilities of the Arm, Shoulder and Hand [DASH] questionnaire', 'acromiohumeral distance', 'Western Ontario Rotator Cuff index and visual analog scale for pain with movement (P<.001', 'Western Ontario Rotator Cuff index), pain (visual analog scale), and acromiohumeral distance', 'Disabilities of the Arm, Shoulder and Hand questionnaire, Western Ontario Rotator Cuff index, visual analog scale, and acromiohumeral distance (P≥.055', 'short-term efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C1568272', 'cui_str': 'Tendinopathy'}]","[{'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0224362', 'cui_str': 'Latissimus Dorsi'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",42.0,0.163816,"No significant group-by-time interaction was observed for the Disabilities of the Arm, Shoulder and Hand questionnaire, Western Ontario Rotator Cuff index, visual analog scale, and acromiohumeral distance (P≥.055).","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Boudreau', 'Affiliation': ''}, {'ForeName': 'Nathaly', 'Initials': 'N', 'LastName': 'Gaudreault', 'Affiliation': ''}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Roy', 'Affiliation': ''}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Bédard', 'Affiliation': ''}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Balg', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2019.8240']
268,30501389,Cost-Effectiveness Evaluation of Manual Physical Therapy Versus Surgery for Carpal Tunnel Syndrome: Evidence From a Randomized Clinical Trial.,"BACKGROUND


Carpal tunnel syndrome (CTS) results in substantial societal costs and can be treated either by nonsurgical or surgical approaches.
OBJECTIVE


To evaluate differences in cost-effectiveness of manual physical therapy versus surgery in women with CTS.
METHODS


In this randomized clinical trial, 120 women with a clinical and an electromyographic diagnosis of CTS were randomized through concealed allocation to either manual physical therapy or surgery. Interventions consisted of 3 sessions of manual physical therapy, including desensitization maneuvers of the central nervous system, or decompression/release of the carpal tunnel. Societal costs and health-related quality of life (estimated by the European Quality of Life-5 Dimensions [EQ-5D] scale) over 1 year were used to generate incremental cost per quality-adjusted life year ratios for each treatment.
RESULTS


The analysis was possible for 118 patients (98%). Incremental quality-adjusted life years showed greater cost-effectiveness in favor of manual physical therapy (difference, 0.135; 95% confidence interval: 0.134, 0.136). Manual therapy was significantly less costly than surgery (mean difference in cost per patient, €2576; P<.001). Patients in the surgical group received a greater number of other treatments and made more visits to medical doctors than those receiving manual physical therapy (P = .02). Absenteeism from paid work was significantly higher in the surgery group (P<.001). The major contributors to societal costs were the treatment protocol (surgery versus manual therapy mean difference, €106 980) and absenteeism from paid work (surgery versus manual physical therapy mean difference, €42 224).
CONCLUSION


Manual physical therapy, including desensitization maneuvers of the central nervous system, has been found to be equally effective but less costly (ie, more cost-effective) than surgery for women with CTS. From a cost-benefit perspective, the proposed CTS manual physical therapy intervention can be considered.
LEVEL OF EVIDENCE


Economic and decision analyses, level 1b. J Orthop Sports Phys Ther 2019;49(2):55-63. Epub 30 Nov 2018. doi:10.2519/jospt.2019.8483.",2019,"Manual therapy was significantly less costly than surgery (mean difference in cost per patient, €2576; P<.001).","['women with CTS', '120 women with a clinical and an electromyographic diagnosis of CTS', '118 patients (98', 'women with CTS.\nMETHODS', 'Carpal Tunnel Syndrome', 'Carpal tunnel syndrome (CTS']","['manual physical therapy, including desensitization maneuvers of the central nervous system, or decompression/release of the carpal tunnel', 'CTS manual physical therapy intervention', 'Manual Physical Therapy Versus Surgery', 'Manual physical therapy', 'manual physical therapy', 'manual physical therapy or surgery']","['Societal costs and health-related quality of life', 'Absenteeism from paid work', 'cost-effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0556520', 'cui_str': 'Desensitization (Psychology)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",120.0,0.068602,"Manual therapy was significantly less costly than surgery (mean difference in cost per patient, €2576; P<.001).","[{'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': ''}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ortega-Santiago', 'Affiliation': ''}, {'ForeName': 'Homid Fahandezh-Saddi', 'Initials': 'HF', 'LastName': 'Díaz', 'Affiliation': ''}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Salom-Moreno', 'Affiliation': ''}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': ''}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Pareja', 'Affiliation': ''}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Arias-Buría', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2019.8483']
269,31226405,Keys to staying sharp: A randomized clinical trial of piano training among older adults with and without mild cognitive impairment.,"BACKGROUND


The prevalence of dementia, the most expensive medical condition (Kirschstein, 2000 and Hurd et al., 2013 [1,2]), and its precursor, mild cognitive impairment (MCI) are increasing [3]. Finding effective intervention strategies to prevent or delay dementia is imperative to public health. Prior research provides compelling evidence that central auditory processing (CAP) deficits are a risk factor for dementia [4-6]. Grounded in the information degradation theory [7, 8], we hypothesize that improving brain function at early perceptual levels (i.e., CAP) may be optimal to attenuate cognitive and functional decline and potentially curb dementia prevalence. Piano training is one avenue to enhance cognition [9-13] by facilitating CAP at initial perceptual stages [14-18].
OBJECTIVES


The Keys To Staying Sharp study is a two arm, randomized clinical trial examining the efficacy of piano training relative to music listening instruction to improve CAP, cognition, and everyday function among older adults. In addition, the moderating effects of MCI status on piano training efficacy will be examined and potential mediators of intervention effects will be explored.
HYPOTHESES


We hypothesize that piano training will improve CAP and cognitive performance, leading to functional improvements. We expect that enhanced CAP will mediate cognitive gains. We further hypothesize that cognitive gains will mediate functional improvements.
METHOD


We plan to enroll 360 adults aged 60 years and older who will be randomized to piano training or an active control condition of music listening instruction and complete pre- and immediate post- assessments of CAP, cognition, and everyday function.",2019,Prior research provides compelling evidence that central auditory processing (CAP) deficits are a risk factor for dementia [4-6].,"['360 adults aged 60\u202fyears and older who will be randomized to', 'older adults with and without mild cognitive impairment', 'older adults']","['piano training or an active control condition of music listening instruction and complete pre- and immediate post- assessments of CAP, cognition, and everyday function', 'piano training relative to music listening instruction', 'Piano training', 'piano training']","['CAP, cognition, and everyday function', 'CAP and cognitive performance']","[{'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]","[{'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'function'}]",360.0,0.0510187,Prior research provides compelling evidence that central auditory processing (CAP) deficits are a risk factor for dementia [4-6].,"[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Hudak', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, University of South Florida. Electronic address: ehudak@health.usf.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bugos', 'Affiliation': 'School of Music, University of South Florida.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Andel', 'Affiliation': 'School of Aging Studies, University of South Florida; Department of Neurology, Charles University and Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Lister', 'Affiliation': 'Department of Communication Sciences and Disorders, University of South Florida.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Ji', 'Affiliation': 'College of Nursing, University of South Florida.'}, {'ForeName': 'Jerri D', 'Initials': 'JD', 'LastName': 'Edwards', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, University of South Florida; Department of Communication Sciences and Disorders, University of South Florida.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.06.003']
270,30661082,Dried blood spot compared to plasma measurements of blood-based biomarkers of brain injury in neonatal encephalopathy.,"BACKGROUND


Data correlating dried blood spots (DBS) and plasma concentrations for neonatal biomarkers of brain injury are lacking. We hypothesized that candidate biomarker levels determined from DBS can serve as a reliable surrogate for plasma levels.
METHODS


In the context of a phase II multi-center trial evaluating erythropoietin for neuroprotection in neonatal encephalopathy (NE), DBS were collected at enrollment ( < 24 h), day 2, 4, and 5. Plasma was collected with the first and last DBS. The relationship between paired DBS-plasma determinations of brain-specific proteins and cytokines was assessed by correlation and Bland-Altman analyses. For analytes with consistent DBS-plasma associations, DBS-derived biomarker levels were related to brain injury by MRI and 1-year outcomes.
RESULTS


We enrolled 50 newborns with NE. While S100B protein, tumor necrosis factor α, interleukin (IL)1 β, IL-6, IL-8 demonstrated significant DBS-plasma correlations, Bland-Altman plots demonstrated that the methods are not interchangeable, with a 2 to 4-fold error between measurements. No significant relationships were found between DBS levels of TNFα, IL-6, and IL-8 and outcomes.
CONCLUSION


Further work is needed to optimize elution and assay methods before using DBS specimens as a reliable surrogate for plasma levels of candidate brain injury biomarkers in NE.",2019,"While S100B protein, tumor necrosis factor α, interleukin (IL)1 β, IL-6, IL-8 demonstrated significant DBS-plasma correlations,",['50 newborns with NE'],['Dried blood spot'],"['Plasma', 'DBS levels of TNFα, IL-6, and IL-8 and outcomes', 'While S100B protein, tumor necrosis factor α, interleukin (IL)1 β, IL-6, IL-8 demonstrated significant DBS-plasma correlations']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy'}]","[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",50.0,0.106799,"While S100B protein, tumor necrosis factor α, interleukin (IL)1 β, IL-6, IL-8 demonstrated significant DBS-plasma correlations,","[{'ForeName': 'An N', 'Initials': 'AN', 'LastName': 'Massaro', 'Affiliation': ""Pediatrics - Division of Neonatology, Children's National Health Systems and The George Washington University School of Medicine, Washington, DC, USA. anguyenm@cnmc.org.""}, {'ForeName': 'Yvonne W', 'Initials': 'YW', 'LastName': 'Wu', 'Affiliation': 'Neurology and Pediatrics, UCSF, San Francisco, CA, USA.'}, {'ForeName': 'Theo K', 'Initials': 'TK', 'LastName': 'Bammler', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'MacDonald', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Mathur', 'Affiliation': 'Pediatrics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Taeun', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': ""Neurology and Pediatrics, Children's National Health Systems and The George Washington University School of Medicine, Washington, DC, USA.""}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Mayock', 'Affiliation': 'Pediatrics-Division of Neonatology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Mulkey', 'Affiliation': ""Neurology and Pediatrics, Children's National Health Systems and The George Washington University School of Medicine, Washington, DC, USA.""}, {'ForeName': 'Krisa', 'Initials': 'K', 'LastName': 'van Meurs', 'Affiliation': 'Pediatrics, Stanford, Palo Alto, CA, USA.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Afsharinejad', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'Pediatrics-Division of Neonatology, University of Washington, Seattle, WA, USA.'}]",Pediatric research,['10.1038/s41390-019-0298-7']
271,32305012,"The effect of combined functional training on BDNF, IGF-1, and their association with health-related fitness in the multiple sclerosis women.","OBJECTIVE


Exercise-induced changes in the neurotrophic factors and the physical function are essential for the rehabilitation of the multiple sclerosis (MS) persons. The aim of this study was investigating of effectiveness of the combined functional training (CFT) on brain-derived neurotrophic factor (BDNF), insulin-like growth factor-1 (IGF-1), and their association with health-related fitness in the MS women.
DESIGN


Twenty women with relapsing-remitting MS randomly assigned to CFT and control (CON) groups. The CFT consisted of 8 weeks (3 days per week) rhythmic aerobic exercise, TRX suspension training, elastic band training, and bodyweight training. BDNF, IGF-1, and health-related fitness components were assessed before and after the intervention.
RESULTS


There was no significant difference in BDNF level between the CFT and the CON group. In contrast, IGF-1, walking speed, and strength of the right- and left-hand was significantly increased in the CFT compared with the CON group. Furthermore, there was a significant and positive correlation between IGF-1 and some fitness components.
CONCLUSIONS


The findings indicated that CFT might a useful training mode in the rehabilitation of the MS women. CFT improved IGF-1 level that is a neuroprotective agent in MS. Positive and significant association between IGF-1 and some health-related fitness components indicates of the importance of IGF-1 in the rehabilitation of the MS persons than BDNF.",2020,"In contrast, IGF-1, walking speed, and strength of the right- and left-hand was significantly increased in the CFT compared with the CON group.","['Twenty women with relapsing-remitting MS randomly assigned to', 'multiple sclerosis women']","['combined functional training', 'CFT', 'CFT and control (CON', 'combined functional training (CFT', 'CON', 'rhythmic aerobic exercise, TRX suspension training, elastic band training, and bodyweight training']","['brain-derived neurotrophic factor (BDNF), insulin-like growth factor-1 (IGF-1', 'BDNF, IGF-1, and health-related fitness components', 'IGF-1, walking speed, and strength of the right- and left-hand', 'IGF-1 level', 'BDNF level']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1504637', 'cui_str': 'TXN protein, human'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",20.0,0.0229704,"In contrast, IGF-1, walking speed, and strength of the right- and left-hand was significantly increased in the CFT compared with the CON group.","[{'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Abbaspoor', 'Affiliation': 'Department of Sport Physiology and Corrective Exercise, Sport Sciences Faculty, Urmia University, Urmia, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Zolfaghari', 'Affiliation': 'Department of Sport Physiology and Corrective Exercise, Sport Sciences Faculty, Urmia University, Urmia, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Ahmadi', 'Affiliation': 'Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Khodaei', 'Affiliation': 'Department of Sport Physiology and Corrective Exercise, Sport Sciences Faculty, Urmia University, Urmia, Iran. Electronic address: k.khodaei@urmia.ac.ir.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101320']
272,32305456,Computerized intervention for reducing intimate partner victimization for perinatal women seeking mental health treatment: A multisite randomized clinical trial protocol.,"Intimate partner victimization (IPV) is a significant social and public health problem among perinatal women. Research suggests that 21% to 33% of perinatal women report IPV and there is an enormous amount of morbidity associated with IPV. Moreover, IPV places women at high risk for several psychiatric disorders, which transforms the perinatal period from an already challenging process into a potentially overwhelming one. Further, IPV and untreated mental illness during the perinatal period pose a dual risk of adverse physical and emotional outcomes for women and their developing fetus/infant. Given the high rates of IPV among women who seek mental health treatment, mental health clinics compared to other medical settings are more effective sites for focused case finding and intervention. Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment (SURE). SURE is a brief, interactive program consistent with motivational interviewing and incorporates empowerment strategies. The proposed multisite randomized clinical trial (N = 186) will test whether SURE relative to control is associated with reduced IPV, greater positive affect and well-being, and greater perceived emotional support. We will also evaluate the role of theoretical mediators of empowerment and self-efficacy. Finally, we will estimate the resources needed and costs to deliver SURE, as well as the incremental cost effectiveness of SURE compared with treatment as usual. If SURE is found to be efficacious and cost effective, it can be easily integrated into clinical care and will fill a critical gap for a vulnerable, high-risk population.",2020,"Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment","['perinatal women seeking mental health treatment', 'women who seek mental health treatment, mental health clinics', 'perinatal women', 'women and their developing fetus/infant']","['Intimate partner victimization (IPV', 'Computerized intervention']",['adverse physical and emotional outcomes'],"[{'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",186.0,0.0511695,"Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment","[{'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychology, University of Akron, Akron, OH 44325-4301, USA. Electronic address: johnsod@uakron.edu.'}, {'ForeName': 'Golfo', 'Initials': 'G', 'LastName': 'Tzilos Wernette', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Ted R', 'Initials': 'TR', 'LastName': 'Miller', 'Affiliation': 'Pacific Institute for Research and Evaluation, Calverton, MD, USA; School of Public Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Muzik', 'Affiliation': 'Department of Psychiatry, Obstetrics & Gynecology, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Raker', 'Affiliation': ""Division of Research, Women and Infant's Hospital, Providence, RI, USA.""}, {'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Zlotnick', 'Affiliation': ""Department of Medicine, Women and Infant's Hospital, Providence, RI, USA; Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106011']
273,32305457,"Translating research into practice: Protocol for a community-engaged, stepped wedge randomized trial to reduce disparities in breast cancer treatment through a regional patient navigation collaborative.","BACKGROUND


Racial and socioeconomic disparities in breast cancer mortality persist. In Boston, MA, Black, Non-Hispanic women and Medicaid-insured individuals are 2-3 times more likely to have delays in treatment compared to White or privately insured women. While evidence-based care coordination strategies for reducing delays exist, they are not systematically implemented across healthcare settings.
METHODS


Translating Research Into Practice (TRIP) utilizes community engaged research methods to address breast cancer care delivery disparities. Four Massachusetts Clinical and Translational Science Institute (CTSI) hubs collaborated with the Boston Breast Cancer Equity Coalition (The Coalition) to implement an evidence-based care coordination intervention for Boston residents at risk for delays in breast cancer care. The Coalition used a community-driven process to define the problem of care delivery disparities, identify the target population, and develop a rigorous pragmatic approach. We chose a cluster-randomized, stepped-wedge hybrid type I effectiveness-implementation study design. The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care. Primary clinical outcomes include time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction. We will use mixed methods to collect the secondary implementation outcomes of acceptability, adoption/penetration, fidelity, sustainability and cost.
CONCLUSION


TRIP utilizes an innovative community-driven research strategy, focused on interdisciplinary collaborations, to design and implement a translational science study that aims to more efficiently integrate proven health services interventions into clinical practice.",2020,"The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care.",[],['stepped-wedge hybrid type'],"['time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction', 'acceptability, adoption/penetration, fidelity, sustainability and cost']",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.050151,"The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care.","[{'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Battaglia', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America. Electronic address: Tracy.Battaglia@bmc.org.""}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Freund', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, United States of America; Division of Internal Medicine and Primary Care, Department of Medicine, Tufts Medical Center, Boston, MA, United States of America; Tufts University School of Medicine, Boston, MA, United States of America.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Casanova', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Bak', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America; Boston University School of Medicine, Boston, MA, United States of America.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cabral', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Freedman', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston, MA, United States of America.'}, {'ForeName': 'Karen Burns', 'Initials': 'KB', 'LastName': 'White', 'Affiliation': 'Initiative to Eliminate Cancer Disparities, Dana Farber/Harvard Cancer Center, Boston, MA, United States of America.'}, {'ForeName': 'Stephenie C', 'Initials': 'SC', 'LastName': 'Lemon', 'Affiliation': 'Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106007']
274,32200304,Effects of sleep restriction on subjective and physiological variables in middle-aged Korean adults: an intervention study.,"BACKGROUND


Adequate sleep is crucial for normal functioning. However, most people, including middle-aged adults of reproductive age, show a marked reduction in their sleep duration. Thus, sleep is a major issue that should be addressed in health management. We investigated the effects of short-term sleep restriction on subjective parameters (sleepiness, stress, fatigue) and physiological parameters (cortisol, thyrotropin [TSH], thyroxine [T4], triiodothyronine [T3], C-reactive protein [CRP]) in middle-aged adults, the recovery of these parameters after rest, and the associations between parameters.
METHODS


A total of 118 healthy adults (59 men, 59 women), aged 35-44 years, and without sleep problems, were enrolled. Participants underwent a 4-h sleep restriction per day for 3 day at a hospital, and then returned to their daily lives to take four days of rest. A questionnaire and blood test were administered before and after sleep restriction, and after the recovery period, to assess subjective and physiological parameters.
RESULTS


After sleep restriction, sleepiness, fatigue, and stress significantly increased compared to baseline. Cortisol and TSH were elevated after sleep restriction, while T4, T3, and CRP were reduced compared to baseline. After the recovery phase, all parameters were restored to levels similar to baseline levels. Changes in each parameter were mutually associated; fatigue and sleepiness had the strongest association.
CONCLUSION


Our results suggest that even a short period of sleep restriction can have an adverse impact on psychological and physiological stress parameters in middle-aged adults, and that adequate rest and sleep are needed to restore them to normal levels.",2020,"Cortisol and TSH were elevated after sleep restriction, while T4, T3, and CRP were reduced compared to baseline.","['118 healthy adults (59 men, 59 women), aged 35-44 years, and without sleep problems, were enrolled', 'middle-aged Korean adults', 'middle-aged adults']","['sleep restriction', 'short-term sleep restriction']","['sleepiness, fatigue, and stress', 'Cortisol and TSH', 'subjective parameters (sleepiness, stress, fatigue) and physiological parameters (cortisol, thyrotropin [TSH], thyroxine [T4], triiodothyronine [T3], C-reactive protein [CRP', 'subjective and physiological variables', 'fatigue and sleepiness']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",118.0,0.0305566,"Cortisol and TSH were elevated after sleep restriction, while T4, T3, and CRP were reduced compared to baseline.","[{'ForeName': 'Younghwa', 'Initials': 'Y', 'LastName': 'Baek', 'Affiliation': 'Future Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea.'}, {'ForeName': 'Kyungsik', 'Initials': 'K', 'LastName': 'Jung', 'Affiliation': 'Future Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea.'}, {'ForeName': 'Siwoo', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Future Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea. Electronic address: ifree72@gmail.com.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.006']
275,32220760,Performance of PI-RADS v2 assessment categories assigned prior to MR-US fusion biopsy in a new fusion biopsy program.,"OBJECTIVE


To validate the performance of PI-RADS v2 for detection of clinically significant prostate cancer (csPca, Gleason ≥7) within the context of a new fusion biopsy program.
MATERIAL AND METHODS


Patients with a PI-RADS v2 assessment category assigned on pre-biopsy mpMRI between March 2015 and November 2017 were identified. Diagnostic performance of PI-RADS v2 was calculated using fusion biopsy results as reference standard using receiver operating characteristic curve analysis. Patient and lesion characteristics were analyzed with one-way ANOVA and Wilcoxon rank sum test.
RESULTS


Of 83 patients with 175 lesions, 115/175 (65.7%) were benign, 21/175 (12%) were Gleason 6, and 39/175 (22.3%) were Gleason ≥7. csPCa rates were 0% (0/5) for PI-RADS 1, 7.4% (2/27) for PI-RADS 2, 5.8% (3/52) for PI-RADS 3, 31.2% (24/77) for PI-RADS 4, and 71.4% (10/14) for PI-RADS 5 (p < 0.0001). For prediction of csPCa, patient-level AUC was 0.68 and lesion-level AUC was 0.77. Biopsy threshold of PI-RADS ≥3 was 92.6% sensitive and 22.1% specific. A threshold of PI-RADS ≥4 was 87.2% sensitive and 58.1% specific. Rate of csPca detection on concurrent standard 12 core biopsy only was 6.7%.
CONCLUSION


PI-RADS v2 assessment categories assigned prior to biopsy predict pathologic outcome reasonably well in a new prostate fusion biopsy program. Biopsy threshold of PI-RADS ≥3 is highly sensitive. A threshold of ≥4 increases specificity but misses some csPCa.",2020,"csPCa rates were 0% (0/5) for PI-RADS 1, 7.4% (2/27) for PI-RADS 2, 5.8% (3/52) for PI-RADS 3, 31.2% (24/77) for PI-RADS 4, and 71.4% (10/14) for PI-RADS 5 (p < 0.0001).","['Patients with a PI-RADS v2 assessment category assigned on pre-biopsy mpMRI between March 2015 and November 2017 were identified', '83 patients with 175 lesions, 115/175 (65.7%) were benign, 21/175 (12%) were Gleason 6, and 39/175 (22.3%) were Gleason ≥7']",['MR-US fusion biopsy'],"['csPCa rates', 'Diagnostic performance of PI-RADS', 'Rate of csPca detection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}]","[{'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}]",83.0,0.0252138,"csPCa rates were 0% (0/5) for PI-RADS 1, 7.4% (2/27) for PI-RADS 2, 5.8% (3/52) for PI-RADS 3, 31.2% (24/77) for PI-RADS 4, and 71.4% (10/14) for PI-RADS 5 (p < 0.0001).","[{'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Trent', 'Affiliation': 'University of Maryland School of Medicine, 655 W Baltimore Street, Baltimore, MD 21201, United States of America. Electronic address: Graham.Trent@somalumni.umaryland.edu.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ye', 'Affiliation': 'University of Maryland School of Medicine, 655 W Baltimore Street, Baltimore, MD 21201, United States of America. Electronic address: Nancy.y.ye@kp.org.'}, {'ForeName': 'Jasleen', 'Initials': 'J', 'LastName': 'Chopra', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 22 South Greene Street, Baltimore, MD 21201, United States of America.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 100 North Greene Street, Suite 411, Baltimore, MD 21201, United States of America. Electronic address: rchen@umm.edu.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Wong-You-Cheong', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 22 South Greene Street, Baltimore, MD 21201, United States of America. Electronic address: jwong@umm.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Naslund', 'Affiliation': 'University of Maryland School of Medicine, Department of Urology, 419 W. Redwood Street, Suite 320, Baltimore, MD 21201, United States of America. Electronic address: mnaslund@som.umaryland.edu.'}, {'ForeName': 'Mohummad M', 'Initials': 'MM', 'LastName': 'Siddiqui', 'Affiliation': 'University of Maryland School of Medicine, Department of Urology, 419 W. Redwood Street, Suite 320, Baltimore, MD 21201, United States of America. Electronic address: msiddiqui@som.umaryland.edu.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Wnorowski', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 22 South Greene Street, Baltimore, MD 21201, United States of America. Electronic address: AmeliaWnorowski@umm.edu.'}]",Clinical imaging,['10.1016/j.clinimag.2020.03.004']
276,32244028,Network topology and machine learning analyses reveal microstructural white matter changes underlying Chinese medicine Dengzhan Shengmai treatment on patients with vascular cognitive impairment.,"With the increasing incidence of cerebrovascular diseases and dementia, considerable efforts have been made to develop effective treatments on vascular cognitive impairment (VCI), among which accumulating practice-based evidence has shown great potential of the traditional Chinese medicine (TCM). Current randomized double-blind controlled trial has been designed to evaluate the 6-month treatment effects of Dengzhan Shengmai (DZSM) capsules, one TCM herbal preparations on VCI, and to explore the underlying neural mechanisms with graph theory-based analysis and machine learning method based on diffusion tensor imaging (DTI) data. A total of 82 VCI patients were recruited and randomly assigned to drug (45 with DZSM) and placebo (37 with placebo) groups, and neuropsychological and neuroimaging data were acquired at baseline and after 6-month treatment. After treatment, compared to the placebo group, the drug groups showed significantly improved performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score (p < 0.001) and the other cognitive domains. And with the reconstruction of white matter structural network, there were more streamlines connecting the left thalamus and right hippocampus in the drug groups (p < 0.001 uncorrected), with decreasing nodal efficiency of the right olfactory associated with slower decline in the general cognition (r = -0.364, p = 0.048). Moreover, support vector machine classification analyses revealed significant white matter network alterations after treatment in the drug groups (accuracy of baseline vs. 6-month later, 68.18 %). Taking together, the present study showed significant efficacy of DZSM treatment on VCI, which might result from white matter microstructure alterations and the topological changes in brain structural network.",2020,"After treatment, compared to the placebo group, the drug groups showed significantly improved performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score (p < 0.001) and the other cognitive domains.","['82 VCI patients', 'patients with vascular cognitive impairment']","['Dengzhan Shengmai (DZSM) capsules, one TCM herbal preparations', 'placebo', 'Network topology and machine learning', 'placebo (37 with placebo', 'DZSM']","['general cognition', 'white matter network alterations', 'nodal efficiency', ""performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3805043', 'cui_str': 'Vascular cognitive impairment'}]","[{'cui': 'C3885966', 'cui_str': 'shengmai'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0949854', 'cui_str': 'Plant Preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002812', 'cui_str': 'Regional Anatomy'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",82.0,0.257526,"After treatment, compared to the placebo group, the drug groups showed significantly improved performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score (p < 0.001) and the other cognitive domains.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou 510515, PR China.'}, {'ForeName': 'Junying', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, PR China; State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'School of Biomedical Engineering, Capital Medical University, Beijing, 100069, PR China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'China-Japan Friendship Hospital 100029, PR China.'}, {'ForeName': 'Caishui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Xuwen', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Wenxiao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Shaokun', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Dongfeng', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, PR China; State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, PR China; State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou 510515, PR China. Electronic address: chengweidong888@sina.com.'}, {'ForeName': 'Zhanjun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China. Electronic address: zhang_rzs@bnu.edu.cn.'}]",Pharmacological research,['10.1016/j.phrs.2020.104773']
277,32244044,Task-dependent modulation of corticospinal excitability and inhibition following strength training.,"This study determined whether there are task-dependent differences in cortical excitability following different types of strength training. Transcranial magnetic stimulation (TMS) measured corticospinal excitability (CSE) and intracortical inhibition (ICI) of the biceps brachii muscle in 42 healthy subjects that were randomised to either paced-strength-training (PST, n = 11), self-paced strength-training (SPST, n = 11), isometric strength-training (IST, n = 10) or to a control group (n = 10). Single-pulse and paired-pulse TMS were applied prior to and following 4-weeks of strength-training. PST increased CSE compared to SPST, IST and the control group (all P < 0.05). ICI was only reduced (60%) following PST. Dynamic strength increased by 18 and 25% following PST and SPST, whilst isometric strength increased by 20% following IST. There were no associations between the behavioural outcome measures and the change in CSE and ICI. The corticospinal responses to strength-training are task-dependent, which is a new finding. Strength-training that is performed slowly could promote use-dependent plasticity in populations with reduced volitional drive, such as during periods of limb immobilization, musculoskeletal injury or stroke.",2020,"Dynamic strength increased by 18 and 25% following PST and SPST, whilst isometric strength increased by 20% following IST.",['42 healthy subjects'],"['paced-strength-training (PST, n\xa0=\xa011), self-paced strength-training (SPST, n\xa0=\xa011), isometric strength-training (IST, n\xa0=\xa010) or to a control group', 'Single-pulse and paired-pulse TMS', 'Transcranial magnetic stimulation (TMS', 'strength training']","['Dynamic strength', 'corticospinal excitability (CSE) and intracortical inhibition (ICI', 'PST increased CSE', 'change in CSE and ICI', 'ICI', 'isometric strength', 'cortical excitability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}]",42.0,0.0265563,"Dynamic strength increased by 18 and 25% following PST and SPST, whilst isometric strength increased by 20% following IST.","[{'ForeName': 'Ummatul', 'Initials': 'U', 'LastName': 'Siddique', 'Affiliation': 'Department of Neurology, Institute of Neurosciences, Kolkata, India.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Department of Neurology, Institute of Neurosciences, Kolkata, India.'}, {'ForeName': 'Ashlyn', 'Initials': 'A', 'LastName': 'Frazer', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Leung', 'Affiliation': 'Department of Physiology, School of Biomedical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Pearce', 'Affiliation': 'College of Science, Health and Engineering, School of Allied Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Dawson J', 'Initials': 'DJ', 'LastName': 'Kidgell', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Australia. Electronic address: dawson.kidgell@monash.edu.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102411']
278,32332591,Effects of group cognitive-behavioral therapy on psychological distress of awaiting-trial prison inmates.,"BACKGROUND/OBJECTIVES


The level of psychological distress among awaiting-trial inmates is rapidly increasing in Nigeria. Studies have recommended increasing attention and additional psychological intervention that could improve the psychological wellbeing of prisoners. This study evaluates the effect of cognitive behavioral therapy on psychological distress among awaiting-trial prison inmates in Nigeria.
METHODS


A total of 34 awaiting-trial prison inmates in Enugu state Nigeria were used as the study participants. Two measures (perceived emotional distress inventory and general health Questionnaire) were used for data collection. Repeated measures with analysis of variance (ANOVA) were used to examine the effects of the intervention. Effect sizes were also reported with partial Eta Squared ((Equation is included in full-text article.)).
RESULTS


The result showed that there was no significant difference in psychological distress between the treatment and no-intervention groups. The results showed that CBT had a significant effect on psychological distress of awaiting-trial prison inmates when compared to their counterparts in the no-intervention group at Time 2. Additionally, the efficacy of CBT on the psychological distress of awaiting-trial prison inmates was significantly sustained at the follow-up measurements (Time 3).
CONCLUSION


This study suggests that cognitive behavioral therapy is an effective intervention for decreasing psychological distress among awaiting-trial prison inmates. Additionally, the impactful benefit of the intervention can persist in overtime. Therefore, cognitive behavioral therapists can further explore the efficacy of CBT using various cultures.",2020,This study suggests that cognitive behavioral therapy is an effective intervention for decreasing psychological distress among awaiting-trial prison inmates.,"['awaiting-trial prison inmates', 'awaiting-trial prison inmates in Nigeria', 'psychological distress of awaiting-trial prison inmates', '34 awaiting-trial prison inmates in Enugu state Nigeria were used as the study participants']","['group cognitive-behavioral therapy', 'CBT', 'cognitive behavioral therapy']","['level of psychological distress', 'emotional distress inventory and general health Questionnaire', 'partial Eta Squared', 'psychological distress']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C1720127', 'cui_str': 'Eta'}]",34.0,0.0294526,This study suggests that cognitive behavioral therapy is an effective intervention for decreasing psychological distress among awaiting-trial prison inmates.,"[{'ForeName': 'Chijioke Virgilus', 'Initials': 'CV', 'LastName': 'Amoke', 'Affiliation': 'Department of Educational Foundations, Faculty of Education.'}, {'ForeName': 'Moses Onyemaechi', 'Initials': 'MO', 'LastName': 'Ede', 'Affiliation': 'Department of Educational Foundations, Faculty of Education.'}, {'ForeName': 'Bonaventure N', 'Initials': 'BN', 'LastName': 'Nwokeoma', 'Affiliation': 'Department of Sociology and Anthropology, Faculty of Social Sciences, University of Nigeria, Nsukka.'}, {'ForeName': 'Sebastian O', 'Initials': 'SO', 'LastName': 'Onah', 'Affiliation': 'Department of Sociology and Anthropology, Faculty of Social Sciences, University of Nigeria, Nsukka.'}, {'ForeName': 'Amaka B', 'Initials': 'AB', 'LastName': 'Ikechukwu-Ilomuanya', 'Affiliation': 'Department of Educational Foundations, Faculty of Education.'}, {'ForeName': 'Florence C', 'Initials': 'FC', 'LastName': 'Albi-Oparaocha', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, Alex Ekwueme Federal University, Ndufu-Alike Ebonyi State.'}, {'ForeName': 'Maduka L', 'Initials': 'ML', 'LastName': 'Nweke', 'Affiliation': 'Department of Physiology, Faculty of Basic Medical Sciences, College of Medicine, University of Nigeria, Ituku Ozalla Enugu Campus.'}, {'ForeName': 'Chijioke V', 'Initials': 'CV', 'LastName': 'Amoke', 'Affiliation': 'Department of Educational Foundations, Faculty of Education.'}, {'ForeName': 'Kingsley C', 'Initials': 'KC', 'LastName': 'Amadi', 'Affiliation': 'Department of Sociology and Anthropology, Faculty of Social Sciences, University of Nigeria, Nsukka.'}, {'ForeName': 'Henry E', 'Initials': 'HE', 'LastName': 'Aloh', 'Affiliation': 'Health Economics and Research Unit, Department of Health Services, Alex Ekwueme Federal University, Ndufu-Alike Ebonyi State.'}, {'ForeName': 'Emenike N', 'Initials': 'EN', 'LastName': 'Anyaegbunam', 'Affiliation': 'Department of Psychology, Faculty of Management, Alex Ekwueme Federal University, Ndufu-Alike Ebonyi State.'}, {'ForeName': 'Chinyere A', 'Initials': 'CA', 'LastName': 'Nwajiuba', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, Alex Ekwueme Federal University, Ndufu-Alike Ebonyi State.'}, {'ForeName': 'Onyeyilichukwu P', 'Initials': 'OP', 'LastName': 'Onwuama', 'Affiliation': 'Department of Sociology and Anthropology, Faculty of Social Sciences, University of Nigeria, Nsukka.'}, {'ForeName': 'Kelechi R', 'Initials': 'KR', 'LastName': 'Ede', 'Affiliation': 'Department of Agricultural Science Education, University of Nigeria, Nsukka.'}, {'ForeName': 'Agnes I', 'Initials': 'AI', 'LastName': 'Ononaiwu', 'Affiliation': 'Department of Educational Foundations, Faculty of Education.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Nweze', 'Affiliation': 'Department of Educational Foundations, Ebonyi State University, Abakaliki Nigeria.'}]",Medicine,['10.1097/MD.0000000000018034']
279,32332608,Two head positions for orotracheal intubation with the trachway videolight intubating stylet with manual in-line stabilization: A randomized controlled trial.,"BACKGROUND


The Trachway Videolight Intubating Stylet is a video-assisted system with a rigid but malleable intubating stylet that facilitates endotracheal intubation. Minimizing cervical spine movement with manual in-line stabilization is essential for patients with cervical spine injuries such as multiple trauma. However, the intubation time of the Trachway Videolight Intubating Stylet and complications associated with intubation in patients with manual in-line stabilization in the neutral-head and head-lift positions remain unclear.
METHODS


Patients (20-80 years old) who were scheduled to undergo surgery that required general anesthesia with tracheal intubation were randomly allocated to either a neutral-head (n = 62) or a head-lift position (n = 62) group. Manual in-line stabilization was performed to limit cervical spine mobility. We aimed to evaluate orotracheal intubation time and success rate in these 2 positions with the Trachway Videolight Intubating Stylet.
RESULTS


Intubation was faster in the head-lift than in the neutral-head position (20 ± 10 and 25 ± 13 seconds, respectively, P = .000); intubation was equally successful in the 2 positions (96.8% vs 96.8%). Responses to intubation did not differ between positions (heart rate, P = .142; visual analog scale scores for throat soreness, P = .54). The only significant predictor of intubation time was the body mass index in the head-lift position group (P = .005).
CONCLUSIONS


Intubation using the Trachway Videolight Intubating Stylet with manual in-line stabilization is faster in the head-lift position, and therefore preferable. However, if the head-lift position is not suitable, the neutral-head position is a sensible alternative, with comparable intubation success rate, heart rate change, and postoperative throat soreness.",2020,"Responses to intubation did not differ between positions (heart rate, P = .142; visual analog scale scores for throat soreness, P = .54).","['patients with manual in-line stabilization in the neutral-head and head-lift positions remain unclear', 'Patients (20-80 years old) who were scheduled to undergo surgery that required general anesthesia with tracheal intubation', 'patients with cervical spine injuries']","['manual in-line stabilization', 'neutral-head (n\u200a=\u200a62) or a head-lift position', 'Trachway Videolight', 'orotracheal intubation with the trachway videolight intubating stylet with manual in-line stabilization']","['visual analog scale scores for throat soreness', 'intubation time of the Trachway Videolight', 'orotracheal intubation time and success rate', 'intubation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0432666', 'cui_str': 'Injury of cervical spine'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}]",,0.0898193,"Responses to intubation did not differ between positions (heart rate, P = .142; visual analog scale scores for throat soreness, P = .54).","[{'ForeName': 'Wei-Hung', 'Initials': 'WH', 'LastName': 'Chan', 'Affiliation': 'Department of Anesthesiology, Tri-Service General Hospital.'}, {'ForeName': 'Chiao-Pei', 'Initials': 'CP', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, Tri-Service General Hospital.'}, {'ForeName': 'Yu-Lung', 'Initials': 'YL', 'LastName': 'Chiu', 'Affiliation': 'Graduate Institute of Medical Sciences.'}, {'ForeName': 'Yung-Chi', 'Initials': 'YC', 'LastName': 'Hsu', 'Affiliation': 'Department of Anesthesiology, Tri-Service General Hospital.'}, {'ForeName': 'Mei-Hua', 'Initials': 'MH', 'LastName': 'Hu', 'Affiliation': 'Division of Pediatric General Medicine, Chang Gung Memorial Hospital, LinKou Branch.'}, {'ForeName': 'Go-Shine', 'Initials': 'GS', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Tri-Service General Hospital.'}]",Medicine,['10.1097/MD.0000000000019645']
280,32289518,Effects of supervised high-intensity resistance and impact training or machine-based isometric training on regional bone geometry and strength in middle-aged and older men with low bone mass: The LIFTMOR-M semi-randomised controlled trial.,"INTRODUCTION


Few data exist on the effects of bone-targeted exercise on geometric and biomechanical indices of bone strength in men. The Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation for Men (LIFTMOR-M) trial was designed to compare the efficacy and safety of two novel, supervised, twice-weekly, high-intensity exercise programs in middle-aged and older men with osteopenia and osteoporosis on musculoskeletal health and risk factors related to falls and fractures. The current report includes secondary outcomes of the LIFTMOR-M exercise intervention trial.
PURPOSE


Our goal was to determine the effects of two supervised, twice-weekly, high-intensity exercise programs on bone geometry and strength of the proximal femur, and distal and proximal sites of the tibia and radius in middle-aged and older men with osteopenia and osteoporosis.
METHODS


Generally-healthy men (≥45 years), with low lumbar spine (LS) and/or proximal femur areal bone mineral density (aBMD), were recruited from the community. Eligible participants were randomised to either eight months of twice-weekly supervised high-intensity progressive resistance and impact training (HiRIT) or supervised machine-based isometric axial compression (IAC) exercise training. Intervention group outcomes were compared at baseline and eight months with a matched but non-randomised control group (CON) who self-selected to usual activities. DXA scans (Medix DR, Medilink, France) of the skeletally non-dominant proximal femur were analysed using 3D hip software (DMS Group, France) to derive femoral neck (FN) and total hip (TH) bone mineral content (BMC), volume, and volumetric bone mineral density (vBMD) for total, trabecular and cortical bone compartments. Total FN cortical thickness was determined as well as anterior, posterior, lateral and medial subregions. pQCT scans (XCT-3000, Stratec, Germany) of the 4 and 38% sites of the tibia, and 4 and 66% sites of the radius were conducted to determine a range of geometric and bone structural strength indices. Intervention effects were examined using univariate ANCOVA of percent change, and repeated measures ANCOVA of raw baseline and follow-up data, controlling for initial values, using intention-to-treat and per-protocol approaches.
RESULTS


Ninety-three men (67.1 ± 7.5 yrs, 175.2 ± 6.7 cm, 82.1 ± 11.6 kg, 26.7 ± 3.5 kg/m 2 ) with lower than average aBMD (LS T-score -0.06 ± 1.04, FN T-score -1.58 ± 0.58, TH T-score -1.00 ± 0.58) were recruited, and designated CON (n = 26) or randomised to HiRIT (n = 34) or IAC (n = 33). Compliance to the supervised exercise programs did not differ (HiRIT 77.8 ± 16.6% versus IAC 78.5 ± 14.8%, p = 0.872). HiRIT improved medial FN cortical thickness compared with CON (5.6 ± 1.7% versus -0.1 ± 1.9%, p = 0.028) and IAC (5.6 ± 1.7% versus 0.7 ± 1.7%, p = 0.044). Distal tibia total BMC, vBMD, area and bone strength index, and trabecular BMC and bone strength index all declined for CON compared with maintenance for both HiRIT and IAC (all p < 0.05). HiRIT maintained distal tibia trabecular area compared with a loss in CON (0.2 ± 0.5% versus -1.6 ± 0.5%, p = 0.013). HiRIT and IAC maintained distal radius total BMC compared with loss in CON (-0.1 ± 0.7% versus -3.7 ± 0.8%, p = 0.001; 1.3 ± 0.7% versus -3.7 ± 0.8%, p < 0.001, respectively). HiRIT and IAC maintained distal radius total bone strength index compared with loss in CON (1.4 ± 1.4% versus -6.0 ± 1.6%, p = 0.001; 0.2 ± 1.3% versus -6.0 ± 1.6%, p = 0.004, respectively). HiRIT reduced proximal radius cortical area compared with CON (-3.1 ± 1.0% versus 1.1 ± 1.2%, p = 0.011) and IAC (-3.1 ± 1.0% versus -0.2 ± 1.0%, p = 0.042). No between-group differences were detected in any pQCT-derived bone outcome at the diaphyseal tibia 38% site.
CONCLUSION


Findings indicate that supervised HiRIT provides a positive stimulus to cortical bone at the medial FN compared with supervised IAC exercise, and both HiRIT and IAC preserve bone strength at the distal tibia and distal radius. These effects may translate into a reduced risk of lower and upper extremity fracture in middle-aged and older men with low bone mass.",2020,"No between-group differences were detected in any pQCT-derived bone outcome at the diaphyseal tibia 38% site.
","['middle-aged and older men with osteopenia and osteoporosis', 'Eligible participants', 'middle-aged and older men with low bone mass', 'Ninety-three men (67.1\u202f±\u202f7.5\u202fyrs, 175.2\u202f±\u202f6.7\u202fcm, 82.1\u202f±\u202f11.6\u202fkg, 26.7\u202f±\u202f3.5\u202fkg/m 2 ) with lower than average aBMD (LS T-score -0.06\u202f±\u202f1.04, FN T-score -1.58\u202f±\u202f0.58, TH T-score -1.00\u202f±\u202f0.58) were recruited, and designated CON (n\u202f=\u202f26) or randomised to', 'men', 'Generally-healthy men (≥45\u202fyears), with low lumbar spine (LS) and/or proximal femur areal bone mineral density (aBMD), were recruited from the community', 'middle-aged and older men with osteopenia and osteoporosis on musculoskeletal health and risk factors related to falls and fractures']","['IAC', 'high-intensity exercise programs', 'Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation', 'supervised high-intensity resistance and impact training or machine-based isometric training', 'HiRIT', 'twice-weekly supervised high-intensity progressive resistance and impact training (HiRIT) or supervised machine-based isometric axial compression (IAC) exercise training']","['HiRIT maintained distal tibia trabecular area', 'pQCT-derived bone outcome', 'femoral neck (FN) and total hip (TH) bone mineral content (BMC), volume, and volumetric bone mineral density (vBMD) for total, trabecular and cortical bone compartments', 'Total FN cortical thickness', 'Distal tibia total BMC, vBMD, area and bone strength index, and trabecular BMC and bone strength index', 'DXA scans (Medix DR, Medilink, France', 'HiRIT and IAC maintained distal radius total BMC', 'HiRIT and IAC maintained distal radius total bone strength index', 'efficacy and safety', 'regional bone geometry and strength', 'medial FN cortical thickness', 'HiRIT reduced proximal radius cortical area']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C5191362', 'cui_str': '1.04'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C4517463', 'cui_str': '0.58'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0588200', 'cui_str': 'Bone structure of distal tibia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0449829', 'cui_str': 'Geometry'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0588205', 'cui_str': 'Bone structure of proximal radius'}]",93.0,0.0493938,"No between-group differences were detected in any pQCT-derived bone outcome at the diaphyseal tibia 38% site.
","[{'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Harding', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Weeks', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Watson', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Weis', 'Affiliation': 'The Bone Clinic, Brisbane, Queensland, Australia.'}, {'ForeName': 'Belinda R', 'Initials': 'BR', 'LastName': 'Beck', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia; The Bone Clinic, Brisbane, Queensland, Australia. Electronic address: b.beck@griffith.edu.au.'}]",Bone,['10.1016/j.bone.2020.115362']
281,32325373,"Safety, tolerability, pharmacokinetics, and pharmacodynamics of macimorelin in healthy adults: Results of a single-dose, randomized controlled study.","OBJECTIVE


Macimorelin is an orally active ghrelin receptor agonist indicated for the diagnosis of adult growth hormone (GH) deficiency in the United States. This phase 1 study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of macimorelin (including a supratherapeutic dose to be used in a thorough QT trial) in healthy adults.
DESIGN


Participants were randomized to receive macimorelin 0.5, 1.0, or 2.0 mg/kg or placebo in 1 of 3 sequential ascending-dose cohorts. Blood samples for pharmacokinetic and pharmacodynamic assays were collected pre-dose and at specified time points over a 24-h period. Pharmacokinetic parameters assessed included area under the concentration-time curve (AUC), maximum concentration (C max ) of macimorelin in plasma, time to C max  (t max ), and terminal elimination half-life (t 1/2 ). Pharmacodynamic assessments evaluated levels of GH, adrenocorticotropic hormone, thyroid-stimulating hormone, cortisol, and prolactin. Safety was assessed based on treatment-emergent adverse events (TEAEs), vital signs, 12‑lead electrocardiograms, and laboratory parameters.
RESULTS


A total of 28 healthy adults were enrolled and completed the study. Macimorelin AUC and C max  showed less than dose-proportional increases following administration of 0.5 and 1.0 mg/kg. Mean t 1/2  was 3.51 h for macimorelin 0.5 and 1.0 mg/kg and 8.29 h for macimorelin 2.0 mg/kg; median t max  occurred at 0.5 to 0.75 h. GH levels increased after dosing, with a t max  of 0.75 h to 1.0 h. Mean GH C max  was similar with the macimorelin 0.5- and 1.0-mg/kg doses (31.9 and 37.8 ng/mL, respectively) and was ~50% lower with macimorelin 2.0 mg/kg (18.4 ng/mL). Transient increases were observed in adrenocorticotropic hormone, cortisol, and prolactin, which were not dose related. A total of 19 TEAEs were reported in 35.7% (10/28) of participants; all TEAEs were mild or moderate and resolved. A total of 12 drug-related TEAEs were reported in 8 participants. Headache was the most common drug-related TEAE. All doses of macimorelin prolonged mean QTcF by 10 to 11 ms. There were no clinically meaningful changes in vital signs or laboratory parameters.
CONCLUSIONS


Single-dose administration of macimorelin 0.5 to 2.0 mg/kg was well tolerated. Macimorelin exposure was less than dose-proportional over the dose range studied. Administration of macimorelin stimulated GH production, with the greatest increases observed in the macimorelin 0.5- and 1.0-mg/kg groups.",2020,"Safety was assessed based on treatment-emergent adverse events (TEAEs), vital signs, 12‑lead electrocardiograms, and laboratory parameters.
","['28 healthy adults', 'healthy adults']","['macimorelin', 'macimorelin prolonged mean', 'placebo']","['Pharmacodynamic assessments evaluated levels of GH, adrenocorticotropic hormone, thyroid-stimulating hormone, cortisol, and prolactin', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'GH levels', 'Headache', 'vital signs or laboratory parameters', 'tolerated', 'Pharmacokinetic parameters assessed included area under the concentration-time curve (AUC), maximum concentration (C max ) of macimorelin in plasma, time to C max  (t max ), and terminal elimination half-life', 'Mean GH C max', 'treatment-emergent adverse events (TEAEs), vital signs, 12‑lead electrocardiograms, and laboratory parameters', 'adrenocorticotropic hormone, cortisol, and prolactin', 'Safety, tolerability, pharmacokinetics, and pharmacodynamics of macimorelin', 'Macimorelin AUC and C max']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C2986922', 'cui_str': 'macimorelin'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0202056', 'cui_str': 'Growth hormone measurement'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C2986922', 'cui_str': 'macimorelin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",28.0,0.152206,"Safety was assessed based on treatment-emergent adverse events (TEAEs), vital signs, 12‑lead electrocardiograms, and laboratory parameters.
","[{'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Klaus', 'Affiliation': 'Nuvisan GmbH, Neu-Ulm, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sachse', 'Affiliation': 'Aeterna Zentaris GmbH, Frankfurt, Germany.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Ammer', 'Affiliation': 'Aeterna Zentaris GmbH, Frankfurt, Germany.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Kelepouris', 'Affiliation': 'Novo Nordisk Inc., Plainsboro, New Jersey, United States. Electronic address: nlkp@novonordisk.com.'}, {'ForeName': 'Vlady', 'Initials': 'V', 'LastName': 'Ostrow', 'Affiliation': 'Novo Nordisk Inc., Plainsboro, New Jersey, United States.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101321']
282,32217148,"Oleoylethanolamide supplementation in obese patients newly diagnosed with non-alcoholic fatty liver disease: Effects on metabolic parameters, anthropometric indices, and expression of PPAR-α, UCP1, and UCP2 genes.","The effects of oleoylethanolamide (OEA) on NAFLD are yet to be examined in human. The objective of the present study was to examine the effects of OEA supplementation along with weight loss intervention on the expression of PPAR-α, uncoupling proteins 1and 2 (UCP1 and UCP2) genes in the peripheral blood mononuclear cells (PBMCs), metabolic parameters, and anthropometric indices among obese patients with NAFLD. In this triple-blind placebo-controlled randomized clinical trial, 76 obese patients newly diagnosed with NAFLD were randomly allocated into either OEA or placebo group along with calorie-restricted diets for 12 weeks. At pre-and post-intervention phase, mRNA expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, serum levels of metabolic parameters as well as diet and appetite sensations were assessed. There was a significant increase in the expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, compared to the placebo at the endpoint. A significant decrease in the anthropometric indices, energy and carbohydrate intakes, glycemic parameters, except for hemoglobin A1c concentration was also observed in the OEA group, compared to the placebo group. OEA treatment significantly resulted in decreased serum levels of triglyceride (TG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), ALT/AST, increased serum levels of high-density lipoprotein cholesterol (HDL-C), and improved appetite sensations. Importantly, a significant improvement in TG, ALT, AST, ALT/AST, HDL-C levels as well as appetite sensations by OEA were under the influence of body mass index (BMI). Although liver steatosis severity was significantly reduced in both groups, the between-group differences did not reach statistical significance (P = 0.061). In conclusion, the present study, for the first time, revealed that OEA supplementation significantly improved anthropometric and metabolic risk factors related to NAFLD.",2020,"There was a significant increase in the expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, compared to the placebo at the endpoint.","['76 obese patients newly diagnosed with NAFLD', 'obese patients newly diagnosed with non-alcoholic fatty liver disease', 'obese patients with NAFLD']","['OEA', 'oleoylethanolamide (OEA', 'Oleoylethanolamide supplementation', 'placebo', 'OEA supplementation', 'OEA or placebo']","['liver steatosis severity', 'mRNA expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, serum levels of metabolic parameters as well as diet and appetite sensations', 'serum levels of triglyceride (TG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), ALT/AST, increased serum levels of high-density lipoprotein cholesterol (HDL-C), and improved appetite sensations', 'expression levels of PPAR-α, UCP1, and UCP2 genes', 'TG, ALT, AST, ALT/AST, HDL-C levels', 'anthropometric indices, energy and carbohydrate intakes, glycemic parameters, except for hemoglobin A1c concentration', 'expression of PPAR-α, uncoupling proteins 1and 2 (UCP1 and UCP2) genes in the peripheral blood mononuclear cells (PBMCs), metabolic parameters, and anthropometric indices', 'anthropometric and metabolic risk factors']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0166418', 'cui_str': 'Peroxisome Proliferator-Activated Receptors'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",76.0,0.0855709,"There was a significant increase in the expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, compared to the placebo at the endpoint.","[{'ForeName': 'Helda', 'Initials': 'H', 'LastName': 'Tutunchi', 'Affiliation': 'Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: helda.nutrition@gmail.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: ostadrahimi@tbzmed.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saghafi-Asl', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Saghafiaslm@gmail.com.'}, {'ForeName': 'Mohammad-Javad', 'Initials': 'MJ', 'LastName': 'Hosseinzadeh-Attar', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mhosseinzadeh@tums.ac.ir.'}, {'ForeName': 'Abolhasan', 'Initials': 'A', 'LastName': 'Shakeri', 'Affiliation': 'Department of Radiology, Imam Reza Teaching Hospital, Clinical Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: shakeria@tbzmed.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Asghari-Jafarabadi', 'Affiliation': 'Road Traffic Injury Research Center, School of Health, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: m.asghari862@gmail.com.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Roshanravan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Neda.roshanravan10@gmail.com.'}, {'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Farrin', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: nazilafarrin@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Naemi', 'Affiliation': 'Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Hasankhani', 'Affiliation': 'Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Pharmacological research,['10.1016/j.phrs.2020.104770']
283,32232698,Long-term (up to 16 months) health-related quality of life after adjuvant tailored dose-dense chemotherapy vs. standard three-weekly chemotherapy in women with high-risk early breast cancer.,"PURPOSE


To prospectively compare HRQoL effects of two modern adjuvant chemotherapy breast cancer treatment regimens at six time-points up to 16 months after random assignment.
METHODS


The open-label, randomized, Phase 3 ""Panther trial"" was conducted between February 2007 and September 2011. 760 women, aged 65 years and younger, after surgery for non-metastatic node-positive or high-risk node-negative breast cancer were randomized 1:1 to the experimental group (four cycles of tailored and dose-dense adjuvant epirubicin and cyclophosphamide/2 weeks followed by four cycles of tailored dose-dense docetaxel/2 weeks) or standard group (three cycles of fluorouracil and epirubicin-cyclophosphamide/3 weeks followed by three cycles of docetaxel/3 weeks). HRQoL was assessed at all Swedish centres using EORTC QLQ-C30 and EORTC QLQ-BR23 at six points during 16 months before randomization.
RESULTS


Response rates to questionnaires were highest at baseline 728/780 (93%) and lowest 16 months after randomization, 557/750 (74%). HRQoL declined during treatment in both groups. At the end of treatment, the experimental group reported statistically significantly lower HRQoL (P < 0.001) than the standard group on global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects. No differences were found for emotional functioning, body image, and arm and breast symptoms. There were no statistically significant differences between the groups at the first follow-up and at subsequent assessments. HRQoL levels at the 16-month follow-up were similar to baseline values.
CONCLUSIONS


Negative HRQoL impact of the dose-dense and tailored strategy appears to be prominent during treatment, but HRQoL recover once treatment ends.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00798070; isrctn.org Identifier: ISRCTN39017665.",2020,"At the end of treatment, the experimental group reported statistically significantly lower HRQoL (P < 0.001) than the standard group on global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects.","['two modern adjuvant chemotherapy breast cancer treatment regimens at six time-points up to 16\xa0months after random assignment', '760 women, aged 65\xa0years and younger, after surgery for non-metastatic node-positive or high-risk node-negative breast cancer', 'women with high-risk early breast cancer']","['tailored and dose-dense adjuvant epirubicin and cyclophosphamide/2\xa0weeks followed by four cycles of tailored dose-dense docetaxel/2\xa0weeks) or standard group (three cycles of fluorouracil and epirubicin-cyclophosphamide/3', 'adjuvant tailored dose-dense chemotherapy vs. standard three-weekly chemotherapy']","['HRQoL levels', 'emotional functioning, body image, and arm and breast symptoms', 'HRQoL', 'HRQoL effects', 'health-related quality of life', 'global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects']","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",760.0,0.0933665,"At the end of treatment, the experimental group reported statistically significantly lower HRQoL (P < 0.001) than the standard group on global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects.","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Brandberg', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden. yvonne.brandberg@ki.se.'}, {'ForeName': 'Hemming', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hellström', 'Affiliation': 'Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Möbus', 'Affiliation': 'Department of Gynecology and Obstetrics, Goethe University Frankfurt/M, Frankfurt, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Medical Department, Medical University Hospital, Salzburg, Austria.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Foukakis', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bergh', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Breast cancer research and treatment,['10.1007/s10549-020-05602-9']
284,32247220,Surgical resection of macrocystic lymphatic malformations of the head and neck: Short and long-term outcomes.,"BACKGROUND


Controversy exists on management of lymphatic malformations, with schools of thought advocating for observation, surgery or sclerotherapy. This study sought to examine outcomes after surgical resection of pediatric cervicofacial macrocystic lymphatic malformations (MLM).
METHODS


Case series with planned data collection on pediatric patients with cervicofacial MLM who underwent surgical resection at a tertiary referral center for vascular anomalies from January 1995 to June 2016. For consistency in patient population analysis, patients who had pre-surgical sclerotherapy or had mixed or microcystic disease were excluded. The main outcome was complete response rate (CR) and long-term recurrence-free survival (RFS).
RESULTS


Sixty-three patients who underwent excision of MLM were included, 52.4% were female, 77.8% Caucasian. The majority had de Serres stage I-III (96.8%) affecting the neck (71.4%). Patients were discharged the same day (28.6%), or had a 1 day median length-of-stay (interquartile range (IQR) = 2). Surgical complications included seroma/hematoma (9.5%), transient nerve weakness (facial nerve, sympathetic chain, or phrenic nerve, 6.3%), and infection (1.6%). On long-term follow-up (median: 12 months, IQR 1-43 months), a single surgery achieved CR in 90.5% of patients. RFS was achieved in 86% of patients in our observation period of up to 15 years. Most patients requiring a second intervention failed within 6-months of initial procedure (4/5 patients, 90%); associated factors included bilaterality, advanced staging, and partial response at first-follow-up (p = 0.0051, 0.0051, and <0.0001, respectively).
CONCLUSIONS


Surgery is safe and effective as first line treatment for selected MLM. For stage I-III MLM CR and long-term RFS can be achieved with a single surgery. A direct and randomized comparison of treatment modalities is needed.",2020,"Most patients requiring a second intervention failed within 6-months of initial procedure (4/5 patients, 90%); associated factors included bilaterality, advanced staging, and partial response at first-follow-up (p = 0.0051, 0.0051, and <0.0001, respectively).
","['pediatric patients with cervicofacial MLM who underwent surgical resection at a tertiary referral center for vascular anomalies from January 1995 to June 2016', 'Surgical resection of macrocystic lymphatic malformations of the head and neck', 'patient population analysis, patients who had pre-surgical sclerotherapy or had mixed or microcystic disease were excluded', 'Sixty-three patients who underwent excision of MLM were included, 52.4% were female, 77.8% Caucasian']",[],"['transient nerve weakness (facial nerve, sympathetic chain, or phrenic nerve, 6.3%), and infection', 'seroma/hematoma', 'bilaterality, advanced staging, and partial response', 'complete response rate (CR) and long-term recurrence-free survival (RFS', 'RFS']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2314896', 'cui_str': 'FAMMM'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0158570', 'cui_str': 'Vascular malformation'}, {'cui': 'C0398368', 'cui_str': 'Lymphatic malformation'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],"[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0015462', 'cui_str': 'Facial nerve structure'}, {'cui': 'C0228972', 'cui_str': 'Sympathetic trunk structure'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}]",63.0,0.129015,"Most patients requiring a second intervention failed within 6-months of initial procedure (4/5 patients, 90%); associated factors included bilaterality, advanced staging, and partial response at first-follow-up (p = 0.0051, 0.0051, and <0.0001, respectively).
","[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bonilla-Velez', 'Affiliation': ""Division of Pediatric Otolaryngology and Center for the Investigation of Congenital Aberrancies of Vascular Development, Arkansas Children's Hospital, 1 Children's Way, Little Rock, AR, USA; Department of Otolaryngology-Head and Neck Surgery, University of Arkansas for Medical Sciences, 4301 W Markham St #543, Little Rock, AR, USA. Electronic address: juliana.bonilla-velez@seattlechildrens.org.""}, {'ForeName': 'Brendan P', 'Initials': 'BP', 'LastName': 'Moore', 'Affiliation': 'College of Medicine, University of Arkansas for Medical Sciences, 4301 W Markham St #550, Little Rock, AR, USA.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Cleves', 'Affiliation': 'Department of Pediatrics and Biostatistics, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Buckmiller', 'Affiliation': ""Baylor College of Medicine. 1 Baylor Plaza, Houston, TX, USA; Children's Hospital of San Antonio, 333 N Santa Rosa St, San Antonio, TX, USA.""}, {'ForeName': 'Gresham T', 'Initials': 'GT', 'LastName': 'Richter', 'Affiliation': ""Division of Pediatric Otolaryngology and Center for the Investigation of Congenital Aberrancies of Vascular Development, Arkansas Children's Hospital, 1 Children's Way, Little Rock, AR, USA; Department of Otolaryngology-Head and Neck Surgery, University of Arkansas for Medical Sciences, 4301 W Markham St #543, Little Rock, AR, USA.""}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110013']
285,29236527,Paradoxical Effects of Intranasal Oxytocin on Trust in Inpatient and Community Adolescents.,"Research suggests that oxytocin, a neuropeptide implicated in attachment, is a promising clinical tool because it increases affiliation and attachment behaviors, which are reduced in a range of psychiatric disorders. Oxytocin has been recommended as a psychiatric treatment for adolescents, but this remains largely unstudied. Skepticism is warranted, based on mixed findings in adults and absence of data across development. The objective of this study was to examine the effect of intranasal oxytocin on attachment-related and non-attachment-related trust in an interactive game, determining how this effect differs among inpatient adolescents and healthy controls and whether this effect is moderated by attachment security. There were 122 adolescents (ages 12-17;  n  = 75 inpatient, 70% female, 37% Black, 24% Hispanic, 20% White, and 20% multiracial;  n  = 46 control, 55% female, 75% Caucasian) randomized to receive self-administered intranasal oxytocin or a placebo and play a trust game with their mother and a stranger over the Internet. Oxytocin only affected the trust game behavior of adolescents when attachment security was moderate or low. At these levels, oxytocin increased the trust of patients, such that their behavior was equivalent to that of healthy controls. Paradoxically, oxytocin reduced the investments of healthy control subjects. This study takes a first step toward determining whether, and for whom, oxytocin may have a trust-enhancing effect and challenges simplistic notions of oxytocin as the attachment-chemical of the brain-pointing instead to differential oxytocin effects based upon clinical status (patient vs. control) and attachment security.",2019,"Research suggests that oxytocin, a neuropeptide implicated in attachment, is a promising clinical tool because it increases affiliation and attachment behaviors, which are reduced in a range of psychiatric disorders.","['Inpatient and Community Adolescents', '122 adolescents (ages 12-17; n\xa0=\xa075 inpatient, 70% female, 37% Black, 24% Hispanic, 20% White, and 20% multiracial; n\xa0=\xa046 control, 55% female, 75% Caucasian', 'inpatient adolescents and healthy controls', 'healthy control subjects']","['Intranasal Oxytocin', 'intranasal oxytocin', 'Oxytocin', 'self-administered intranasal oxytocin or a placebo and play a trust game with their mother and a stranger over the Internet', 'oxytocin']",[],"[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]",[],122.0,0.141052,"Research suggests that oxytocin, a neuropeptide implicated in attachment, is a promising clinical tool because it increases affiliation and attachment behaviors, which are reduced in a range of psychiatric disorders.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Venta', 'Affiliation': 'Department of Philosophy & Psychology, Sam Houston State University.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Ha', 'Affiliation': 'Department of Pediatrics, University of Texas Health Sciences Center.'}, {'ForeName': 'Salome', 'Initials': 'S', 'LastName': 'Vanwoerden', 'Affiliation': 'Department of Psychology, University of Houston.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Newlin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Sciences Center.'}, {'ForeName': 'Lane', 'Initials': 'L', 'LastName': 'Strathearn', 'Affiliation': 'Center for Disabilities and Development, University of Iowa.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Sharp', 'Affiliation': 'Department of Psychology, University of Houston.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2017.1399401']
286,30967642,Weight loss at your fingertips: personalized nutrition with fasting glucose and insulin using a novel statistical approach.,"BACKGROUND/OBJECTIVES


Precision medicine is changing the way people are diagnosed and treated into a more personalized approach. Using a novel statistical approach, we demonstrate how two diets cause differential weight loss depending on pre-treatment fasting plasma glucose (FPG) and fasting insulin (FI) levels.
SUBJECTS/METHODS


One hundred and eighty-one overweight people with increased waist circumference were randomly assigned to receive an ad libitum New Nordic Diet (NND) high in dietary fiber and whole grain or an Average Danish (Western) Diet (ADD) for 26 weeks. All foods were provided free of charge. Body weight was measured throughout the study and blood was drawn before randomization from where FPG and FI were analyzed. Weight was described by linear mixed models including biomarker (FPG or FI) diet group interactions. Individualized predictions were estimated as contrasts of intercepts and slopes of pre-treatment biomarkers.
RESULTS


Every mmol/L increase in baseline FPG predicted a between-diet difference of 3.00 (1.18;4.83, n = 181, P = 0.001) kg larger weight loss from choosing NND over ADD. For instance, a baseline FPG level of 4.7 mmol/L would lead to an average of 1.42 kg larger weight loss on NND vs. ADD (above 0.41 kg with 95% certainty), whereas the average effect size would be 8.33 kg (above 5.50 kg with 95% certainty) among subjects with FPG level of 7.0 mmol/L. Among individuals with FPG <5.6 mmol/L, each pmol/L lower baseline FI predicted a 0.039 (95% CI 0.017;0.061, n = 143, P < 0.001) kg larger weight loss from choosing NND over ADD.
CONCLUSIONS


Use of pre-treatment FPG and FI led to truly individualized predictions of treatment effect of introducing more fiber and whole grain in the diet on weight loss, ranging from almost no effect to losing >8 kg. These findings suggest that this novel statistical approach has great potential when re-evaluating data from existing randomized controlled trials.",2019,"L lower baseline FI predicted a 0.039 (95% CI 0.017;0.061, n = 143, P < 0.001) kg larger weight loss from choosing NND over ADD.
","['individuals with FPG <5.6\u2009mmol/L, each pmol', 'One hundred and eighty-one overweight people with increased waist circumference']",['ad libitum New Nordic Diet (NND) high in dietary fiber and whole grain or an Average Danish (Western) Diet (ADD'],"['weight loss', 'Weight loss', 'Body weight', 'weight loss depending on pre-treatment fasting plasma glucose (FPG) and fasting insulin (FI) levels', 'baseline FPG']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0439192', 'cui_str': 'pmol'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",181.0,0.0415728,"L lower baseline FI predicted a 0.039 (95% CI 0.017;0.061, n = 143, P < 0.001) kg larger weight loss from choosing NND over ADD.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark. madsfiil@nexs.ku.dk.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0423-z']
287,31168085,Mucosal lactoferrin response to genital tract infections is associated with iron and nutritional biomarkers in young Burkinabé women.,"BACKGROUND/OBJECTIVES


The iron-binding affinity of vaginal lactoferrin (Lf) reduces iron available to genital pathogens. We describe host reproductive, nutritional, infection and iron biomarker profiles affecting vaginal Lf concentration in young nulliparous and primigravid women in Burkina Faso.
SUBJECTS/METHODS


Vaginal eluates from women who had participated in a randomized, controlled periconceptional iron supplementation trial were used to measure Lf using a competitive double-sandwich ELISA. For this analysis samples from both trial arms were combined and pregnant and non-pregnant cohorts compared. Following randomization Lf was measured after 18 months (end assessment) for women remaining non-pregnant, and at two antenatal visits for those becoming pregnant. Associations between log Lf levels and demographic, anthropometric, infection and iron biomarker variables were assessed using linear mixed models.
RESULTS


Lf samples were available for 712 non-pregnant women at end assessment and for 303 women seen at an antenatal visit. Lf concentrations of pregnant women were comparable to those of non-pregnant, sexually active women. Lf concentration increased with mid-upper-arm circumference, (P = 0.047), body mass index (P = 0.018), Trichomonas vaginalis (P < 0.001) infection, bacterial vaginosis (P < 0.001), serum C-reactive protein (P = 0.048) and microbiota community state types III/IV. Adjusted Lf concentration was positively associated with serum hepcidin (P = 0.047), serum ferritin (P = 0.018) and total body iron stores (P = 0.042). There was evidence that some women maintained persistently high or low Lf concentrations from before, and through, pregnancy.
CONCLUSION


Lf concentrations increased with genital infection, higher BMI, MUAC, body iron stores and hepcidin, suggesting nutritional and iron status influence homeostatic mechanisms controlling vaginal Lf responses.",2019,"Lf concentration increased with mid-upper-arm circumference, (P = 0.047), body mass index (P = 0.018), Trichomonas vaginalis (P < 0.001) infection, bacterial vaginosis (P < 0.001), serum C-reactive protein (P = 0.048) and microbiota community state types III/IV.","['young nulliparous and primigravid women in Burkina Faso', '712 non-pregnant women at end assessment and for 303 women seen at an antenatal visit', 'pregnant women', 'young Burkinabé women', 'Vaginal eluates from women who had participated']",[],"['Lf concentration', 'Adjusted Lf concentration', 'log Lf levels and demographic, anthropometric, infection and iron biomarker variables', 'Mucosal lactoferrin response', 'Lf concentrations', 'Lf concentrations increased with genital infection, higher BMI, MUAC, body iron stores and hepcidin, suggesting nutritional and iron status influence homeostatic mechanisms controlling vaginal Lf responses', 'serum hepcidin', 'serum C-reactive protein', 'serum ferritin', 'body mass index', 'total body iron stores', 'Trichomonas vaginalis']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0301870', 'cui_str': 'Eluate'}]",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0729552', 'cui_str': 'Infectious disease of genitopelvic system'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1561987', 'cui_str': 'Homeostatic mechanism'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0040922', 'cui_str': 'Trichomonas vaginalis'}]",,0.0939264,"Lf concentration increased with mid-upper-arm circumference, (P = 0.047), body mass index (P = 0.018), Trichomonas vaginalis (P < 0.001) infection, bacterial vaginosis (P < 0.001), serum C-reactive protein (P = 0.048) and microbiota community state types III/IV.","[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Roberts', 'Affiliation': 'Centre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, Faculty of Biology, Medicine and Health, School of Medical Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Brabin', 'Affiliation': 'Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Diallo', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gies', 'Affiliation': 'Department of Biomedical Sciences, Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium and Medical Mission Institute, Würzburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nelson', 'Affiliation': 'Faculty of Health and Life Sciences, University of Northumbria, Northumberland Building, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Swinkels', 'Affiliation': 'Department of Laboratory Medicine (TLM 830), Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Geurts-Moespot', 'Affiliation': 'Department of Laboratory Medicine (TLM 830), Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kazienga', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ouedraogo', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': ""D'Alessandro"", 'Affiliation': 'Medical Research Council Unit (MRC), Fajara, The Gambia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Clinical Research Unit of Nanoro (URCN/IRSS), Nanoro, Burkina Faso.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Brabin', 'Affiliation': 'Liverpool School of Tropical Medicine, and Institute of Infection and Global Health, University of Liverpool, Liverpool, UK. b.j.brabin@liverpool.ac.uk.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0444-7']
288,31400517,Clinical exome sequencing vs. usual care for hereditary colorectal cancer diagnosis: A pilot comparative effectiveness study.,"BACKGROUND


Clinical exome sequencing (CES) provides the advantage of assessing genetic variation across the human exome compared to a traditional stepwise diagnostic approach or multi-gene panels. Comparative effectiveness research methods offer an approach to better understand the patient-centered and economic outcomes of CES.
PURPOSE


To evaluate CES compared to usual care (UC) in the diagnostic work-up of inherited colorectal cancer/polyposis (CRCP) in a randomized controlled trial (RCT).
METHODS


The primary outcome was clinical sensitivity for the diagnosis of inherited CRCP; secondary outcomes included psychosocial outcomes, family communication, and healthcare resource utilization. Participants were surveyed 2 and 4 weeks after results return and at 3-month intervals up to 1 year.
RESULTS


Evolving outcome measures and standard of care presented critical challenges. The majority of participants in the UC arm received multi-gene panels [94.73%]. Rates of genetic findings supporting the diagnosis of hereditary CRCP were 7.5% [7/93] vs. 5.4% [5/93] in the CES and UC arms, respectively (P = 0.28). Differences in privacy concerns after receiving CRCP results were identified (0.88 in UC vs 0.38 in CES, P = 0.05); however, healthcare resource utilization, family communication and psychosocial outcomes were similar between the two arms. More participants with positive results (17.7%) intended to change their life insurance 1  month after the first return visit compared to participants returned a variant of uncertain significance (9.1%) or negative result (4.8%) (P = 0.09).
CONCLUSION


Our results suggest that CES provides similar clinical benefits to multi-gene panels in the diagnosis of hereditary CRCP.",2019,"Differences in privacy concerns after receiving CRCP results were identified (0.88 in UC vs 0.38 in CES, P = 0.05); however, healthcare resource utilization, family communication and psychosocial outcomes were similar between the two arms.",['hereditary colorectal cancer diagnosis'],"['CES', 'usual care (UC']","['healthcare resource utilization, family communication and psychosocial outcomes', 'privacy concerns', 'clinical sensitivity for the diagnosis of inherited CRCP; secondary outcomes included psychosocial outcomes, family communication, and healthcare resource utilization']","[{'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",[],"[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0080048', 'cui_str': 'Privacy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",,0.0971893,"Differences in privacy concerns after receiving CRCP results were identified (0.88 in UC vs 0.38 in CES, P = 0.05); however, healthcare resource utilization, family communication and psychosocial outcomes were similar between the two arms.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Amendola', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Ragan', 'Initials': 'R', 'LastName': 'Hart', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Bennette', 'Affiliation': 'Flatiron Health, New York, NY 10010, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Horike-Pyne', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Trinidad', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Elisabeth A', 'Initials': 'EA', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Comstock', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Nefcy', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Fuki M', 'Initials': 'FM', 'LastName': 'Hisama', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bennett', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Grady', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98101, USA.'}, {'ForeName': 'Carlos J', 'Initials': 'CJ', 'LastName': 'Gallego', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA; Department of Genetics and Genome Sciences, Case Western Reserve University, Cleveland, OH 44106, USA; Comparative Health Outcomes, Economics and Policy Institute (CHOICE), University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tarczy-Hornoch', 'Affiliation': 'Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Fullerton', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Wylie', 'Initials': 'W', 'LastName': 'Burke', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Regier', 'Affiliation': 'Canadian Centre for Applied Research in Cancer Control, BC Cancer Agency, Vancouver, BC V5Z 1L3, Canada.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Dorschner', 'Affiliation': 'Department of Pathology, University of Washington, Seattle, WA 98195, USA; Department of Genome Sciences, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Shirts', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Peggy D', 'Initials': 'PD', 'LastName': 'Robertson', 'Affiliation': 'Department of Genome Sciences, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Nickerson', 'Affiliation': 'Department of Genome Sciences, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Patrick', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'Gail P', 'Initials': 'GP', 'LastName': 'Jarvik', 'Affiliation': 'Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA; Department of Genome Sciences, University of Washington, Seattle, WA 98195, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Veenstra', 'Affiliation': 'Comparative Health Outcomes, Economics and Policy Institute (CHOICE), University of Washington, Seattle, WA 98195, USA. Electronic address: veenstra@uw.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105820']
289,31678222,Effects of a Robot-Assisted Arm Training Plus Hand Functional Electrical Stimulation on Recovery After Stroke: A Randomized Clinical Trial.,"OBJECTIVE


To compare the effects of unilateral, proximal arm robot-assisted therapy combined with hand functional electrical stimulation with intensive conventional therapy for restoring arm function in survivors of subacute stroke.
DESIGN


This was a single-blinded, randomized controlled trial.
SETTING


Inpatient rehabilitation university hospital.
PARTICIPANTS


Patients (N=40) diagnosed as having ischemic stroke (time since stroke <8wk) and upper limb impairment were enrolled.
INTERVENTIONS


Participants randomized to the experimental group received 30 sessions (5 sessions/wk) of robot-assisted arm therapy and hand functional electrical stimulation (RAT+FES). Participants randomized to the control group received a time-matched intensive conventional therapy.
MAIN OUTCOME MEASURES


The primary outcome was arm motor recovery measured with the Fugl-Meyer Motor Assessment. Secondary outcomes included motor function, arm spasticity, and activities of daily living. Measurements were performed at baseline, after 3 weeks, at the end of treatment, and at 6-month follow-up. Presence of motor evoked potentials (MEPs) was also measured at baseline.
RESULTS


Both groups significantly improved all outcome measures except for spasticity without differences between groups. Patients with moderate impairment and presence of MEPs who underwent early rehabilitation (<30d post stroke) demonstrated the greatest clinical improvements.
CONCLUSIONS


RAT+FES was no more effective than intensive conventional arm training. However, at the same level of arm impairment and corticospinal tract integrity, it induced a higher level of arm recovery.",2020,Both groups significantly improved all outcome measures except for spasticity without differences between groups.,"['Forty patients diagnosed with ischemic stroke (time since stroke <8 weeks) and upper limb impairment were enrolled', 'Inpatient Rehabilitation University Hospital', 'subacute stroke survivors']","['robot-assisted arm training plus hand functional electrical stimulation', 'unilateral, proximal arm robot-assisted therapy combined with hand functional electrical stimulation to intensive conventional therapy', 'robot-assisted arm therapy and hand functional electrical stimulation (RAT + FES', 'time-matched intensive conventional therapy (ICT']","['motor evoked potentials (MEPs', 'motor function, arm spasticity and activities of daily living', 'spasticity', 'motor recovery measured with the Fugl-Meyer Motor Assessment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0877408', 'cui_str': 'Arm spasticity'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",40.0,0.430265,Both groups significantly improved all outcome measures except for spasticity without differences between groups.,"[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy. Electronic address: s.straudi@ospfe.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baroni', 'Affiliation': 'Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy; Doctoral Program in Translational Neurosciences and Neurotechnologies, Ferrara University, Ferrara, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Mele', 'Affiliation': 'Biomedical and Specialty Surgical Sciences Department, Ferrara University, Ferrara, Italy.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Craighero', 'Affiliation': 'Biomedical and Specialty Surgical Sciences Department, Ferrara University, Ferrara, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy; Biomedical and Specialty Surgical Sciences Department, Ferrara University, Ferrara, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy; Biomedical and Specialty Surgical Sciences Department, Ferrara University, Ferrara, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Maietti', 'Affiliation': 'Medical Science Department, Center for Clinical Epidemiology, Ferrara University, Ferrara, Italy; Department of Biomedical and Neuromotor Sciences, Bologna University, Bologna, Italy.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy; Biomedical and Specialty Surgical Sciences Department, Ferrara University, Ferrara, Italy.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.09.016']
290,31678223,Low-Intensity vs High-Intensity Home-Based Treadmill Training and Walking Attainment in Young Children With Spastic Diplegic Cerebral Palsy.,"OBJECTIVE


To compare the effect of low-intensity (LI) vs high-intensity (HI) treadmill training (TT) on walking attainment and overall walking activity in children with cerebral palsy (CP).
DESIGN


Prospective, multisite, randomized controlled trial.
SETTING


Homes of the participants.
PARTICIPANTS


Children with spastic diplegic CP, Gross Motor Function Classification System Level I and II, ages 14-32 months (N=19; male, n=8).
INTERVENTIONS


The children were randomized to LI TT (2×/wk for 6wk) (n=10) and HI TT (10×/wk for 6wk) (n=9). The TT was carried out by the families with weekly instruction by the researchers.
MAIN OUTCOME MEASURES


Children were assessed at study onset, post intervention, and 1 and 4 months post intervention with the Gross Motor Function Measure Dimension D/E (GMFM D/E), average strides per day and percentage of time spent walking with accelerometers, the Peabody Developmental Motor Scales-2 (PDMS-2), Pediatric Evaluation of Disability Index Mobility Scale, timed 10-m and 1-minute walk test, and Functional Mobility Scale. Blinding was conducted for GMFM D/E and PDMS-2. Linear mixed effects regression models were applied to all outcomes.
RESULTS


No significant between-group differences were found in any outcome measure at any of the time points. Children in the HI group did not show significant improvement immediately following the intervention in GMFM E (P=.061), while children in the LI group did (P=.003), but no statistically significant differences were detected over time (P=.71). Children in the HI group showed better walking independence on the Functional Mobility Scale at all postintervention assessments.
CONCLUSIONS


A twice-weekly dosage was equally effective in improving skills related to walking compared with a 10×/wk program and can be more readily implemented into clinical practice.",2020,"Children in the HI group did not show significant improvement immediately following the intervention in GMFM-E (p=.061), while children in the LI group did (p=.003), but no statistically significant differences were detected over time (p=.71).","['children with cerebral palsy (CP', ' Homes of the participants PARTICIPANTS: 19 children with spastic diplegic CP, Gross Motor Function Classification System Level I and II, ages 14-32 months (male n=8', 'young children with spastic diplegic cerebral palsy']","['Low-intensity versus high-intensity home-based treadmill training and walking attainment', 'LI TT', 'low-intensity (LI) versus high-intensity (HI) TT']","['GMFM-E', 'Gross Motor Function Measure Dimension D/ E (GMFM-D/E), average strides/day and percentage of time spent walking with accelerometers, the Peabody Developmental Motor Scales-2 (PDMS-2), Pediatric Evaluation of Disability Index Mobility Scale, timed 10-meter and 1-minute walk test, and Functional Mobility Scale', 'walking attainment and overall walking activity', 'walking independence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441925', 'cui_str': 'Level I (tumor staging)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0270804', 'cui_str': 'Cerebral palsy, spastic, diplegic'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",19.0,0.0301917,"Children in the HI group did not show significant improvement immediately following the intervention in GMFM-E (p=.061), while children in the LI group did (p=.003), but no statistically significant differences were detected over time (p=.71).","[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Mattern-Baxter', 'Affiliation': 'Department of Physical Therapy, California State University, Sacramento, California. Electronic address: kbaxter@csus.edu.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Looper', 'Affiliation': 'School of Physical Therapy, University of the Puget Sound, Tacoma, Washington.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Department of Pediatrics, University of Washington, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Bjornson', 'Affiliation': ""Department of Pediatrics, University of Washington, Seattle Children's Research Institute, Seattle, Washington.""}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.09.015']
291,32334074,Bilateral nucleus basalis of Meynert deep brain stimulation for dementia with Lewy bodies: A randomised clinical trial.,"BACKGROUND


Dementia with Lewy bodies (DLB) is the second most common form of dementia. Current symptomatic treatment with medications remains inadequate. Deep brain stimulation of the nucleus basalis of Meynert (NBM DBS) has been proposed as a potential new treatment option in dementias.
OBJECTIVE


To assess the safety and tolerability of low frequency (20 Hz) NBM DBS in DLB patients and explore its potential effects on both clinical symptoms and functional connectivity in underlying cognitive networks.
METHODS


We conducted an exploratory randomised, double-blind, crossover trial of NBM DBS in six DLB patients recruited from two UK neuroscience centres. Patients were aged between 50 and 80 years, had mild-moderate dementia symptoms and were living with a carer-informant. Patients underwent image guided stereotactic implantation of bilateral DBS electrodes with the deepest contacts positioned in the Ch4i subsector of NBM. Patients were subsequently assigned to receive either active or sham stimulation for six weeks, followed by a two week washout period, then the opposite condition for six weeks. Safety and tolerability of both the surgery and stimulation were systematically evaluated throughout. Exploratory outcomes included the difference in scores on standardised measurements of cognitive, psychiatric and motor symptoms between the active and sham stimulation conditions, as well as differences in functional connectivity in discrete cognitive networks on resting state fMRI.
RESULTS


Surgery and stimulation were well tolerated by all six patients (five male, mean age 71.33 years). One serious adverse event occurred: one patient developed antibiotic-associated colitis, prolonging his hospital stay by two weeks. No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients. Active stimulation was associated with functional connectivity changes in both the default mode network and the frontoparietal network.
CONCLUSION


Low frequency NBM DBS can be safely conducted in DLB patients. This should encourage further exploration of the possible effects of stimulation on neuropsychiatric symptoms and corresponding changes in functional connectivity in cognitive networks.
TRIAL REGISTRATION NUMBER


NCT02263937.",2020,"No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients.","['Dementia with Lewy bodies (DLB', 'Patients were aged between 50-80 years, had mild-moderate dementia symptoms and were living with a carer-informant', 'six DLB patients recruited from two UK neuroscience centres', 'DLB patients', 'six patients (five male, mean age 71.33 years']","['NBM DBS', 'Bilateral Nucleus Basalis of Meynert Deep Brain Stimulation', 'image guided stereotactic implantation of bilateral DBS electrodes', 'active or sham stimulation', 'Meynert (NBM DBS']","['severity of neuropsychiatric symptoms', 'tolerated', 'safety and tolerability', 'functional connectivity in discrete cognitive networks on resting state fMRI', 'functional connectivity changes', 'Safety and tolerability', 'standardised measurements of cognitive, psychiatric and motor symptoms', 'antibiotic-associated colitis, prolonging his hospital stay']","[{'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",6.0,0.353614,"No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gratwicke', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK. Electronic address: j.gratwicke@ucl.ac.uk.'}, {'ForeName': 'Ludvic', 'Initials': 'L', 'LastName': 'Zrinzo', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kahan', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Una', 'Initials': 'U', 'LastName': 'Brechany', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'McNichol', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Mazda', 'Initials': 'M', 'LastName': 'Beigi', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Harith', 'Initials': 'H', 'LastName': 'Akram', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hyam', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Oswal', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Day', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mancini', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thornton', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Yousry', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Crutch', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'John-Paul', 'Initials': 'JP', 'LastName': 'Taylor', 'Affiliation': 'Newcastle University & Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McKeith', 'Affiliation': 'Newcastle University & Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Schott', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Limousin', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burn', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Martin N', 'Initials': 'MN', 'LastName': 'Rossor', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Hariz', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Jahanshahi', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK. Electronic address: t.foltynie@ucl.ac.uk.'}]",Brain stimulation,['10.1016/j.brs.2020.04.010']
292,31721277,"Safety and Efficacy of Otaplimastat in Patients with Acute Ischemic Stroke Requiring tPA (SAFE-TPA): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study.","OBJECTIVE


Otaplimastat is a neuroprotectant that inhibits matrix metalloprotease pathway, and reduces edema and intracerebral hemorrhage induced by recombinant tissue plasminogen activator (rtPA) in animal stroke models. We aimed to assess the safety and efficacy of otaplimastat in patients receiving rtPA.
METHODS


This was a phase 2, 2-part, multicenter trial in stroke patients (19-80 years old) receiving rtPA. Intravenous otaplimastat was administered <30 minutes after rtPA. Stage 1 was a single-arm, open-label safety study in 11 patients. Otaplimastat 80 mg was administered twice daily for 3 days. Stage 2 was a randomized, double-blind, placebo-controlled study involving 69 patients, assigned (1:1:1) to otaplimastat 40 mg, otaplimastat 80 mg, or a placebo. The primary endpoint was the occurrence of parenchymal hematoma (PH) on day 1. Secondary endpoints included serious adverse events (SAEs), mortality, and modified Rankin scale (mRS) distribution at 90 days (clinicaltrials.gov identifier: NCT02787278).
RESULTS


No safety issues were encountered in stage 1. The incidence of PH during stage 2 was comparable: 0 of 22 with the placebo, 0 of 22 with otaplimastat 40 mg, and 1 of 21 with the 80 mg dose. No differences in SAEs (13%, 17%, 14%) or death (8.3%, 4.2%, 4.8%) were observed among the 3 groups. Three adverse events (chills, muscle rigidity, hepatotoxicity) were judged to be related to otaplimastat.
INTERPRETATION


Intravenous otaplimastat adjunctive therapy in patients receiving rtPA is feasible and generally safe. The functional efficacy of otaplimastat needs to be investigated with further large trials. ANN NEUROL 2020;87:233-245.",2020,"Three adverse events (chills, muscle rigidity, hepatotoxicity) were judged to be related to otaplimastat.
","['Patients with Acute Ischemic Stroke Requiring tPA (SAFE-TPA', 'stroke patients (19-80\u2009years) receiving', 'patients receiving rtPA', '69 patients']","['Placebo', 'Otaplimastat', 'otaplimastat 40 mg, 80 mg or a placebo', 'rtPA', 'placebo', 'recombinant tissue plasminogen activator (rtPA']","['death', 'incidence of PH', 'SAE', 'adverse events (chills, muscle rigidity, hepatotoxicity', 'Safety and Efficacy', 'serious adverse events (SAE), mortality, and modified Rankin scale (mRS) distribution', 'safety and efficacy', 'occurrence of parenchymal hematoma (PH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0026837', 'cui_str': 'Rigidity, Muscular'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]",69.0,0.507934,"Three adverse events (chills, muscle rigidity, hepatotoxicity) were judged to be related to otaplimastat.
","[{'ForeName': 'Jong S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.'}, {'ForeName': 'Kyung Bok', 'Initials': 'KB', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Soonchunhyang University School of Medicine, Seoul.'}, {'ForeName': 'Jong-Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Myongji Hospital, Hanyang University College of Medicine, Goyang.'}, {'ForeName': 'Sang Min', 'Initials': 'SM', 'LastName': 'Sung', 'Affiliation': 'Department of Neurology, Pusan National University Hospital, Busan.'}, {'ForeName': 'Kyungmi', 'Initials': 'K', 'LastName': 'Oh', 'Affiliation': 'Department of Neurology, Korea University Guro Hospital, Seoul.'}, {'ForeName': 'Eung-Gyu', 'Initials': 'EG', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Inje University Busan Paik Hospital, Busan.'}, {'ForeName': 'Dae-Il', 'Initials': 'DI', 'LastName': 'Chang', 'Affiliation': 'Department of Neurology, Kyung Hee University Hospital, Seoul.'}, {'ForeName': 'Yang Ha', 'Initials': 'YH', 'LastName': 'Hwang', 'Affiliation': 'Department of Neurology, Kyungpook National University School of Medicine and Hospital, Daegu.'}, {'ForeName': 'Eun-Jae', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.'}, {'ForeName': 'Won-Ki', 'Initials': 'WK', 'LastName': 'Kim', 'Affiliation': 'Department of Neuroscience, Korea University College of Medicine, Seoul.'}, {'ForeName': 'Chung', 'Initials': 'C', 'LastName': 'Ju', 'Affiliation': 'Research Headquarters, Shin Poong Pharmaceutical, Ansan, Korea.'}, {'ForeName': 'Byung Su', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Research Headquarters, Shin Poong Pharmaceutical, Ansan, Korea.'}, {'ForeName': 'Jei-Man', 'Initials': 'JM', 'LastName': 'Ryu', 'Affiliation': 'Research Headquarters, Shin Poong Pharmaceutical, Ansan, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25644']
293,31148589,Dietary micronutrient intakes among women of reproductive age in Mumbai slums.,"OBJECTIVES


To (1) describe micronutrient intakes among women of reproductive age living in Mumbai slums; (2) assess the adequacy of these intakes compared with reference values; (3) identify important dietary sources of micronutrients.
SUBJECTS/METHODS


Participants were 6426 non-pregnant women aged 16-39 years, registered in a randomised controlled trial of a food-based intervention set in the Bandra, Khar and Andheri areas of Mumbai, India. Cross-sectional quantified food frequency questionnaire (FFQ) data were collected. Vitamin (n = 9) and mineral (n = 6) intakes were calculated and analysed in relation to dietary reference values (DRVs). Important dietary sources were identified for each micronutrient.
RESULTS


Median intakes of all micronutrients, except vitamin E, were below the FAO/WHO reference nutrient intake (RNI). Intakes of calcium, iron, vitamin A and folate were furthest from the RNI. For seven of the micronutrients, over half of the women had intakes below the lower reference nutrient intake (LRNI); this figure was over 75% for calcium and riboflavin. The majority of women (93%) had intakes below the EAR for 5 or more micronutrients, and 64% for 10 or more. Adolescents had lower intakes than women aged >19 years. Less than 1% of adult women and no adolescents met the EAR for all micronutrients. Animal source foods and micronutrient-rich fruit and vegetables were consumed infrequently.
CONCLUSIONS


These women had low intakes of multiple micronutrients, increasing their risk of insufficiency. There is a need to determine the factors causing poor intakes, to direct interventions that improve diet quality and nutritional sufficiency.",2019,"RESULTS


Median intakes of all micronutrients, except vitamin E, were below the FAO/WHO reference nutrient intake (RNI).","['women of reproductive age living in Mumbai slums', 'Adolescents had lower intakes than women aged >19 years', 'women of reproductive age in Mumbai slums', 'Participants were 6426 non-pregnant women aged 16-39 years']","['Vitamin', 'riboflavin']","['Intakes of calcium, iron, vitamin A and folate', 'Cross-sectional quantified food frequency questionnaire (FFQ) data']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0373720', 'cui_str': 'Vitamin B2'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",6426.0,0.0580757,"RESULTS


Median intakes of all micronutrients, except vitamin E, were below the FAO/WHO reference nutrient intake (RNI).","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Nunn', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Kehoe', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK. sk@mrc.soton.ac.uk.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Chopra', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Sirazul A', 'Initials': 'SA', 'LastName': 'Sahariah', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Di Gravio', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Patsy J', 'Initials': 'PJ', 'LastName': 'Coakley', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'Cox', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Harshad', 'Initials': 'H', 'LastName': 'Sane', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Shivshankaran', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Marley-Zagar', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Barrie M', 'Initials': 'BM', 'LastName': 'Margetts', 'Affiliation': 'Public Health Nutrition, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Jackson', 'Affiliation': 'National Institute for Health Research, Southampton Biomedical Research Centre, Southampton, UK.'}, {'ForeName': 'Ramesh D', 'Initials': 'RD', 'LastName': 'Potdar', 'Affiliation': 'Centre for the Study of Social Change, Mumbai, India.'}, {'ForeName': 'Caroline H D', 'Initials': 'CHD', 'LastName': 'Fall', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0429-6']
294,32338312,"Correction to: Effects of a resistance and balance exercise programme on physical fitness, health-related quality of life and fear of falling in older women with osteoporosis and vertebral fracture: a randomized controlled trial.","The original version of this article, published on 10 January 2020, contained a mistake. An author's name was misspelled.",2020,"The original version of this article, published on 10 January 2020, contained a mistake.",['older women with osteoporosis and vertebral fracture'],['resistance and balance exercise programme'],"['physical fitness, health-related quality of life and fear of falling']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}]",,0.0379202,"The original version of this article, published on 10 January 2020, contained a mistake.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Stanghelle', 'Affiliation': 'Institute of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, St. Olavs Plass, PO Box 4, 0130, Oslo, Norway. bsugland@oslomet.no.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bentzen', 'Affiliation': 'Institute of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, St. Olavs Plass, PO Box 4, 0130, Oslo, Norway.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Giangregorio', 'Affiliation': 'Department of Kinesiology, Schlegel-UW Research Institute for Aging, University of Waterloo, 250 Laurelwood Dr, Waterloo, ON, N2J 0E2, Canada.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Pripp', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, St. Olavs Plass, PO Box 4, 0130, Oslo, Norway.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Skelton', 'Affiliation': 'School of Health and Life Sciences, Centre for Living, Glasgow Caledonian University, Cowcaddens Rd, Glasgow, G4 0BA, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bergland', 'Affiliation': 'Institute of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, St. Olavs Plass, PO Box 4, 0130, Oslo, Norway.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05398-w']
295,32331476,Acute Effect of the Timing of Resistance Exercise and Nutrient Intake on Muscle Protein Breakdown.,"BACKGROUND


Combining resistance exercise (RE) with nutrient intake stimulates muscle protein net balance. However, it is still unclear whether the optimal timing of nutrient intake is before or after RE, especially on muscle protein breakdown (MPB) for an augmented muscle anabolic response. The aim of this study was to investigate the effect of a substantial mixed meal (i.e., nutrient- and protein-dense whole foods) before or after RE, compared with RE without a meal on the acute response of MPB in a crossover-design study.
METHODS


Eight healthy young men performed three trials: (1) meal intake before RE (Pre), (2) meal intake after RE (Post), and (3) RE without meal intake (No). Plasma insulin and 3-methylhistidine (3-MH), an MPB marker, were measured.
RESULTS


Time course change in plasma insulin level after RE was significantly higher in the Post condition than in the Pre and No conditions. The area under the curve of 3-MH concentration was significantly lower in the Post condition than in the Pre and No conditions.
CONCLUSIONS


These results suggest that a substantial mixed meal immediately after RE may effectively suppress MPB in the morning.",2020,"The area under the curve of 3-MH concentration was significantly lower in the Post condition than in the Pre and No conditions.
",['Eight healthy young men performed three trials: (1'],"['resistance exercise (RE) with nutrient intake', 'substantial mixed meal (i.e., nutrient- and protein-dense whole foods', 'Resistance Exercise and Nutrient Intake', 'meal intake before RE (Pre), (2) meal intake after RE (Post), and (3) RE without meal intake (No']","['area under the curve of 3-MH concentration', 'plasma insulin level after RE', 'Plasma insulin and 3-methylhistidine (3-MH), an MPB marker', 'MPB']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453870', 'cui_str': 'Whole food'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0047600', 'cui_str': '3-methyl histidine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1276042', 'cui_str': 'Plasma insulin measurement'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0699900', 'cui_str': 'Catabolism'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",8.0,0.0327376,"The area under the curve of 3-MH concentration was significantly lower in the Post condition than in the Pre and No conditions.
","[{'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Kume', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, 1-1-1 Nojihigashi, Kusatsu, Shiga 525-8577, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yasuda', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, 1-1-1 Nojihigashi, Kusatsu, Shiga 525-8577, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Hashimoto', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, 1-1-1 Nojihigashi, Kusatsu, Shiga 525-8577, Japan.'}]",Nutrients,['10.3390/nu12041177']
296,32331477,Acute Ingestion of A Novel Nitrate-Rich Dietary Supplement Significantly Increases Plasma Nitrate/Nitrite in Physically Active Men and Women.,"BACKGROUND


Dietary supplements purported to increase circulating nitric oxide are very popular among consumers. We determined the acute impact of two novel dietary supplements on plasma nitrate/nitrite (NOx) and nitrite alone.
METHODS


20 men and women (age: 24 ± 5 years) ingested two different nitrate-rich supplements (Resync Recovery Blend at 7.5 g and 15 g; Resync Collagen Blend at 21 g), or placebo, on four different days. Fasting blood samples were obtained before and 75 min following ingestion and analyzed for NOx and nitrite.
RESULTS


Nitrite was not differently impacted by treatment (p > 0.05). The NOx response for men and women was very similar, with no sex interactions noted (p > 0.05). Condition (p < 0.0001), time (p < 0.0001), and condition x time (p < 0.0001) effects were noted for NOx. Values increased from baseline to post-ingestion for the Resync Recovery Blend at 7.5 g (11 ± 9 to 101 ± 48 µM) and at 15 g (9 ± 5 to 176 ± 91µM), as well as for the Resync Collagen Blend (9 ± 9 to 46 ± 21µM), while values for placebo remained stable (9 ± 7 to 8 ± 5µM).
CONCLUSION


While nitrite alone was not impacted by treatment, both Resync products result in an increase in plasma NOx, with the increase proportionate to the quantity of ""nitric oxide blend"" ingredients contained within each product. Future studies are needed to determine the physiological implications of the increased NOx, as pertaining to exercise performance and recovery, in addition to other aspects of human health.",2020,"The NOx response for men and women was very similar, with no sex interactions noted (p > 0.05).","['20 men and women (age: 24 ± 5 years', 'Physically Active Men and Women']","['ingested two different nitrate-rich supplements (Resync Recovery Blend at 7.5 g and 15 g; Resync Collagen Blend at 21 g), or placebo', 'Novel Nitrate-Rich Dietary Supplement']","['condition x time', 'Nitrite', 'plasma nitrate/nitrite (NOx) and nitrite alone', 'NOx response', 'plasma NOx', 'Fasting blood samples', 'Plasma Nitrate/Nitrite']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C1959943', 'cui_str': '21G'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",20.0,0.0615797,"The NOx response for men and women was very similar, with no sex interactions noted (p > 0.05).","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Bloomer', 'Affiliation': 'Center for Nutraceutical and Dietary Supplement Research, School of Health Studies, University of Memphis; Memphis, TN 38152, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Butawan', 'Affiliation': 'Center for Nutraceutical and Dietary Supplement Research, School of Health Studies, University of Memphis; Memphis, TN 38152, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Pigg', 'Affiliation': 'Center for Nutraceutical and Dietary Supplement Research, School of Health Studies, University of Memphis; Memphis, TN 38152, USA.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Martin', 'Affiliation': 'Center for Nutraceutical and Dietary Supplement Research, School of Health Studies, University of Memphis; Memphis, TN 38152, USA.'}]",Nutrients,['10.3390/nu12041176']
297,31326523,"MIND food and speed of processing training in older adults with low education, the MINDSpeed Alzheimer's disease prevention pilot trial.","BACKGROUND


Multiple national organizations and leaders have called for increased attention to dementia prevention in those most vulnerable, for example persons with limited formal education. Prevention recommendations have included calls for multicomponent interventions that have the potential to improve both underlying neurobiological health and the ability to function despite neurobiological pathology, or what has been termed cognitive reserve.
OBJECTIVES


Test feasibility, treatment modifier, mechanism, and cognitive function effects of a multicomponent intervention consisting of foods high in polyphenols (i.e., MIND foods) to target neurobiological health, and speed of processing training to enhance cognitive reserve. We refer to this multicomponent intervention as MINDSpeed.
DESIGN


MINDSpeed is being evaluated in a 2 × 2 randomized factorial design with 180 participants residing independently in a large Midwestern city. Qualifying participants are 60 years of age or older with no evidence of dementia, and who have completed 12 years or less of education. All participants receive a study-issued iPad to access the custom study application that enables participants, depending on randomization, to select either control or MIND food, and to play online cognitive games, either speed of processing or control games.
METHODS


All participants complete informed consent and baseline assessment, including urine and blood samples. Additionally, up to 90 participants will complete neuroimaging. Assessments are repeated immediately following 12 weeks of active intervention, and at 24 weeks post-randomization. The primary outcome is an executive cognitive composite score. Secondary outcomes include oxidative stress, pro-inflammatory cytokines, and neuroimaging-captured structural and functional metrics of the hippocampus and cortical brain regions.
SUMMARY


MINDSpeed is the first study to evaluate the multicomponent intervention of high polyphenol intake and speed of processing training. It is also one of the first dementia prevention trials to target older adults with low education. The results of the study will guide future dementia prevention efforts and trials in high risk populations.",2019,"Prevention recommendations have included calls for multicomponent interventions that have the potential to improve both underlying neurobiological health and the ability to function despite neurobiological pathology, or what has been termed cognitive reserve.
","['older adults with low education', '180 participants residing independently in a large Midwestern city', 'Qualifying participants are 60\u202fyears of age or older with no evidence of dementia, and who have completed 12\u202fyears or less of education']","['multicomponent intervention consisting of foods high in polyphenols (i.e., MIND foods', 'MIND food and speed of processing training', 'control or MIND food, and to play online cognitive games, either speed of processing or control games']","['oxidative stress, pro-inflammatory cytokines, and neuroimaging-captured structural and functional metrics of the hippocampus and cortical brain regions', 'executive cognitive composite score']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",180.0,0.0716363,"Prevention recommendations have included calls for multicomponent interventions that have the potential to improve both underlying neurobiological health and the ability to function despite neurobiological pathology, or what has been termed cognitive reserve.
","[{'ForeName': 'Daniel O', 'Initials': 'DO', 'LastName': 'Clark', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America; Department of Medicine, Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN, United States of America. Electronic address: daniclar@iu.edu.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America; Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, IN, United States of America.'}, {'ForeName': 'Lyndsi', 'Initials': 'L', 'LastName': 'Moser', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Adeoye', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America.'}, {'ForeName': 'Annie W', 'Initials': 'AW', 'LastName': 'Lin', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, IL, United States of America.'}, {'ForeName': 'Christy C', 'Initials': 'CC', 'LastName': 'Tangney', 'Affiliation': 'Department of Clinical Nutrition, Rush University Medical Center, Chicago, IL, United States of America.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Risacher', 'Affiliation': 'Center for Neuroimaging, Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Saykin', 'Affiliation': 'Center for Neuroimaging, Department of Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': 'Considine', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Frederick W', 'Initials': 'FW', 'LastName': 'Unverzagt', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America; Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105814']
298,31344519,Individual and family-based approaches to increase physical activity in adolescents with intellectual and developmental disabilities: Rationale and design for an 18 month randomized trial.,"Adolescents with intellectual and developmental disabilities (IDD) are less physically active and have lower cardiovascular fitness compared with their typically developing peers. This population faces additional barriers to participation in moderate-to-vigorous physical activity (MVPA) such as reliance on parents, lack of peer-support, and lack of inclusive physical activity opportunities. Previous interventions to increase MVPA in adolescents with IDD have met with limited success, at least in part due to requiring parents to transport their adolescent to an exercise facility. We recently developed a remote system to deliver MVPA to groups of adolescents with IDD in their homes via video conferencing on a tablet computer. This approach eliminates the need for transportation and provides social interaction and support from both a health coach and other participants. We will conduct a 18-mo. trial (6 mos. active, 6 mos. maintenance, 6 mos. no-contact follow-up) to compare changes in objectively assessed MVPA in 114 adolescents with IDD randomized to a single level intervention delivered only to the adolescent (AO) or a multi-level intervention delivered to both the adolescent and a parent (A + P). Our primary aim is to compare increases in MVPA (min/d) between the AO and A + P groups from 0 to 6 mos. Secondarily we will compare changes in MVPA, sedentary time, cardiovascular fitness, muscular strength, motor ability, quality of life, and the percentage of adolescents achieving the US recommendation of 60 min. MVPA/d across 18 mos. We will also explore the influence of process variables/participant characteristics on changes in MVPA across 18 mos. NCT registration: NCT03684512.",2019,We recently developed a remote system to deliver MVPA to groups of adolescents with IDD in their homes via video conferencing on a tablet computer.,"['adolescents with IDD', '114 adolescents with IDD randomized to a', 'Adolescents with intellectual and developmental disabilities (IDD', 'adolescents with intellectual and developmental disabilities']","['MVPA', 'NCT registration', 'single level intervention delivered only to the adolescent (AO) or a multi-level intervention delivered to both the adolescent and a parent (A\u202f+\u202fP']","['MVPA, sedentary time, cardiovascular fitness, muscular strength, motor ability, quality of life, and the percentage of adolescents achieving the US recommendation of 60\u202fmin', 'MVPA', 'physical activity']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0008073', 'cui_str': 'Child Development Disorders'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0034380'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",114.0,0.0419222,We recently developed a remote system to deliver MVPA to groups of adolescents with IDD in their homes via video conferencing on a tablet computer.,"[{'ForeName': 'L T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: lptomey@ku.edu.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: rwashburn@ku.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA. Electronic address: jaehoon.lee@ttu.edu.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Greene', 'Affiliation': 'Department of Health, Sport, and Exercise Sciences, University of Kansas, Lawrence, KS 66045, USA. Electronic address: jlg@ku.edu.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Szabo-Reed', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: aszabo@kumc.edu.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Sherman', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: joesherman@ku.edu.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Danon', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: jdanon@ku.edu.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Osborne', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: lnosborne@ku.edu.'}, {'ForeName': 'T D', 'Initials': 'TD', 'LastName': 'Little', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA. Electronic address: todd.d.little@ttu.edu.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: jdonnelly@ku.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105817']
299,32334176,"The RESPECT trial-Replacement of peripheral intravenous catheters according to clinical reasons or every 96 h: A randomized, controlled, non-inferiority trial.","BACKGROUND


Peripheral intravenous catheters are widely used for infusion therapy. To prevent phlebitis, routine catheter replacement at 72 or 96 h remains widely practiced.
OBJECTIVE


To investigate the non-inferiority of clinically indicated peripheral intravenous catheter replacement compared with routine replacement every 96 h to prevent phlebitis. Phlebitis severity, catheter indwelling time, and other catheter failure types were also compared.
SETTING


Multi-center trial in wards at two hospitals in Sao Paulo, Brazil.
DESIGN


The REplacement of PEripheral intravenous CaTheters according to clinical signs or every 96 h (RESPECT) trial was a Randomized, non-blinded, controlled, non-inferiority trial.
PARTICIPANTS


1319 patients were enrolled with the following inclusion criteria: aged ≥18 years, expected peripheral intravenous therapy for ≥96 h; peripheral intravenous catheters inserted in the selected wards, intensive care units, or surgical centers; and informed consent provided. Exclusion criteria were: bloodstream infection and/or sepsis, neutrophil count of ≤1000/mm 3 , and simultaneous use of more than one peripheral intravenous catheter. Recruitment occurred within 96 h of peripheral intravenous catheter insertion. Randomization was performed using a computer-generated, concealed list.
METHODS


As intervention, clinically indicated replacement group patients underwent peripheral intravenous catheter removal only at the end of therapy or in the presence of phlebitis, infiltration, occlusion, displacement, accidental removal, or bloodstream infection. Routine 96-h replacement group patients (control) had their catheters replaced every 96-h, unless clinical reasons required earlier replacement. The primary outcome was Phlebitis and the analyses were carried out on intention-to-treat and per-protocol bases.
RESULTS


Demographic and clinical variables were similar between groups, with the exception to type of admission (p = 0.025) more frequent in clinically indicated patients and surgical on routine replacement group. Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis. Phlebitis/1000 catheter-days, was 14.9 in the clinically indicated group and 23.8 in the routine replacement group (p = 0.006). The survival analysis showed no significant between-group difference in the occurrence of the first phlebitis episode.
CONCLUSIONS


Clinically indicated peripheral intravenous catheter replacement was not inferior to routine (96 h) replacement regarding phlebitis occurrence, and was associated with significantly less phlebitis per 1000 days.
TRIAL REGISTRATION


Registered with www.clinicaltrials.gov (NCT02568670).",2020,"Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis.","['Multi-center trial in wards at two hospitals in Sao Paulo, Brazil', '1319 patients were enrolled with the following inclusion criteria: aged ≥18 years, expected peripheral intravenous therapy for ≥96\xa0h; peripheral intravenous catheters inserted in the selected wards, intensive care units, or surgical centers; and informed consent provided']","['peripheral intravenous catheters', 'peripheral intravenous catheter replacement', 'peripheral intravenous catheter removal']","['Phlebitis', 'phlebitis', 'intention-to-treat and per-protocol bases', 'Phlebitis severity, catheter indwelling time, and other catheter failure types']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",1319.0,0.175394,"Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Vendramim', 'Affiliation': 'Specialist in pediatric intensive care, M.Sc., Ph.D. in Health Science of Federal University of Sao Paulo, 258 Aimberê, St. Sao Paulo, Brazil. Electronic address: patvendramim@gmail.com.'}, {'ForeName': 'Ariane Ferreira Machado', 'Initials': 'AFM', 'LastName': 'Avelar', 'Affiliation': 'Federal University of Sao Paulo, Brazil. Electronic address: ariane.machado@unifesp.br.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Rickard', 'Affiliation': 'Griffith University - Australia, Australia. Electronic address: c.rickard@griffith.edu.au.'}, {'ForeName': 'Mavilde da Luz Gonçalves', 'Initials': 'MDLG', 'LastName': 'Pedreira', 'Affiliation': 'Federal University of Sao Paulo, Brazil. Electronic address: mpedreira@unifesp.br.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2019.103504']
300,32334292,The impact of fascia iliaca compartment block on chronic postsurgical pain in patients undergoing hip fracture repair.,"STUDY OBJECTIVE


Chronic postsurgical pain (CPSP), i.e. pain persisting >3 months, may appear after any type of surgery. There is a paucity of literature addressing CPSP development after hip fracture repair and the impact of any analgesic intervention on the development of CPSP in patients after hip fracture surgery. This study is the first aiming to examine the impact of ultrasound-guided fascia iliaca compartment block (USG FICB) on the development of CPSP after hip fracture repair.
DESIGN


Prospective randomized study.
SETTING


Operating room.
PATIENTS


182 patients scheduled for hip fracture surgery.
INTERVENTIONS


Patients were randomized to receive a USG FICB (FICB group) or a sham saline injection (sham FICB group), twenty minutes before positioning for spinal anesthesia.
MEASUREMENTS


The hip - related characteristic pain intensity (CPI) at 3- months post-surgery was the primary outcome measure. Presence and severity of hip-related pain at 3- and 6-months post-surgery, numeric rating pain scale (NRS) scores at 6, 24, 36, 48 postoperative hours, total 24-hour tramadol PCA administration and timing of the first tramadol dose, were documented as well.
MAIN RESULTS


FICB group presented with lower CPI scores 3- months postoperatively (p < 0.01), as well as lower percentage of patients with high-grade CPSP, 3 and 6 months postoperatively (p < 0.001). FICB group also showed significantly lower NRS scores in all instances, lower total 24 - hour tramadol consumption and higher mean time to first tramadol dose (p < 0.05). The overall sample of 182 patients reported a considerably high incidence of hip -related CPSP (60% at 3 months, 45% at 6 months).
CONCLUSIONS


USG FICB in the perioperative setting may reduce the incidence, intensity and severity of CPSP at 3 and 6 months after hip fracture surgery, providing safe and effective postoperative analgesia.",2020,"FICB group also showed significantly lower NRS scores in all instances, lower total 24 - hour tramadol consumption and higher mean time to first tramadol dose (p < 0.05).","['patients undergoing hip fracture repair', 'patients after hip fracture surgery', '182 patients reported a considerably high incidence of hip -related', '182 patients scheduled for hip fracture surgery']","['fascia iliaca compartment block', 'ultrasound-guided fascia iliaca compartment block (USG FICB', 'USG FICB (FICB group) or a sham saline injection', 'FICB']","['CPI scores', 'NRS scores', 'CPSP', 'hip - related characteristic pain intensity (CPI', 'numeric rating pain scale (NRS) scores', 'incidence, intensity and severity of CPSP', 'chronic postsurgical pain', 'Presence and severity of hip-related pain', 'total 24-hour tramadol PCA administration and timing of the first tramadol dose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0246008', 'cui_str': 'CPI(1)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",182.0,0.129944,"FICB group also showed significantly lower NRS scores in all instances, lower total 24 - hour tramadol consumption and higher mean time to first tramadol dose (p < 0.05).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Diakomi', 'Affiliation': 'Department of Anesthesiology, Asklepieion Hospital of Voula, Athens, Greece.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Papaioannou', 'Affiliation': 'Department of Anesthesiology, Asklepieion Hospital of Voula, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Georgoudis', 'Affiliation': 'Physiotherapy Department, University of West Attica, Athens, Greece.'}, {'ForeName': 'Erifili', 'Initials': 'E', 'LastName': 'Argyra', 'Affiliation': 'Department of Anesthesiology, Aretaieion University Hospital, Athens, Greece.'}, {'ForeName': 'Argyro', 'Initials': 'A', 'LastName': 'Mela', 'Affiliation': 'Department of Anesthesiology, Asklepieion Hospital of Voula, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Siafaka', 'Affiliation': 'Department of Anesthesiology, Aretaieion University Hospital, Athens, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Department of Anesthesiology, Asklepieion Hospital of Voula, Athens, Greece. Electronic address: makrisalexandros@hotmail.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109801']
301,31782181,Randomized Placebo-Controlled Trial of Intravenous Immunoglobulin in Autoimmune LGI1/CASPR2 Epilepsy.,"OBJECTIVE


Drug-resistant seizures are common in patients with leucine-rich, glioma-inactivated 1 (LGI1)-IgG associated and contactin-associated protein-like 2 (CASPR2)-IgG associated encephalitis. We performed the first randomized double-blind placebo-controlled trial to evaluate efficacy of intravenous immunoglobulin (IVIG) in reducing seizure frequency.
METHODS


Our enrollment goal was 30 LGI1/CASPR2-IgG-seropositive adult patients with ≥2 seizures per week. Patients were randomized to receive IVIG (0.5g/kg day 1, 1g/kg day 2, 0.6g/kg weeks 3 and 5) or volume-matched intravenous normal saline. Following the blinded phase, the nonresponders in the placebo group received IVIG. The primary clinical outcome was 50% reduction in seizure frequency from baseline to 5 weeks.
RESULTS


After enrollment of 17 patients (LGI1-IgG, 14; CASPR2-IgG, 3) over 34 months, the study was terminated due to slow enrollment. Six of 8 patients in the IVIG group were responders, compared to 2 of 9 in the placebo group (p = 0.044, odds ratio = 10.5, 95% confidence interval = 1.1-98.9). For the LGI1-IgG seropositive subgroup, 6 of 8 patients in the IVIG group were responders, compared to zero of 6 in the placebo group. Two LGI1-IgG-seropositive patients receiving IVIG, but none receiving placebo, were seizure-free at the end of the blinded phase. Four of the 6 patients entering the open-label IVIG arm reported ≥50% reduction in seizure frequency. There were no correlations with LGI1/CASPR2-IgG1-4 subclasses.
INTERPRETATION


Superiority of IVIG to placebo reached statistical significance for the primary endpoint for all patients and the subset with LGI1-IgG. These results have to be interpreted with the caveat that the study did not reach its originally selected sample size. ANN NEUROL 2020;87:313-323.",2020,"INTERPREATION


Superiority of IVIG to placebo reached statistical significance for the primary end-point for all patients and the subset with LGI1-IgG.","['30 LGI1/CASPR2-IgG-seropositive adult patients with ≥2 seizures per-week', 'autoimmune LGI1/CASPR2 epilepsy', 'patients with Leucine-rich, glioma-inactivated-1 (LGI1) and contactin-associated-protein-like-2 (CASPR2)-IgG associated encephalitis']","['Placebo', 'volume-matched intravenous normal saline', 'placebo', 'IVIG', 'intravenous immunoglobulin (IVIG']",['seizure frequency'],"[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0017638', 'cui_str': 'Glial Cell Tumors'}, {'cui': 'C0056257'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0014038', 'cui_str': 'Inflammation, Brain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.667386,"INTERPREATION


Superiority of IVIG to placebo reached statistical significance for the primary end-point for all patients and the subset with LGI1-IgG.","[{'ForeName': 'Divyanshu', 'Initials': 'D', 'LastName': 'Dubey', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McKeon', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Gadoth', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Zekeridou', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Sebastian A', 'Initials': 'SA', 'LastName': 'Lopez Chiriboga', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Devine', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jane H', 'Initials': 'JH', 'LastName': 'Cerhan', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Dunlay', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Sagen', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Ramberger', 'Affiliation': 'Oxford Autoimmune Neurology Group, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Waters', 'Affiliation': 'Oxford Autoimmune Neurology Group, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarosh R', 'Initials': 'SR', 'LastName': 'Irani', 'Affiliation': 'Oxford Autoimmune Neurology Group, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Pittock', 'Affiliation': 'Department of Neurology and Immunology, Mayo Clinic, Rochester, MN.'}]",Annals of neurology,['10.1002/ana.25655']
302,31849093,Effect of High-Caloric Nutrition on Survival in Amyotrophic Lateral Sclerosis.,"OBJECTIVE


Weight loss has been identified as a negative prognostic factor in amyotrophic lateral sclerosis, but there is no evidence regarding whether a high-caloric diet increases survival. Therefore, we sought to evaluate the efficacy of a high-caloric fatty diet (HCFD) for increasing survival.
METHODS


A 1:1 randomized, placebo-controlled, parallel-group, double-blinded trial (LIPCAL-ALS study) was conducted between February 2015 and September 2018. Patients were followed up at 3, 6, 9, 12, 15, and 18 months after randomization. The study was performed at 12 sites of the clinical and scientific network of German motor neuron disease centers (ALS/MND-NET). Eligible patients were randomly assigned (1:1) to receive either HCFD (405kcal/day, 100% fat) or placebo in addition to riluzole (100mg/day). The primary endpoint was survival time, defined as time to death or time to study cutoff date.
RESULTS


Two hundred one patients (80 female, 121 male, age = 62.4 ± 10.8 years) were included. The confirmatory analysis of the primary outcome survival showed a survival probability of 0.39 (95% confidence interval [CI] = 0.27-0.51) in the placebo group and 0.37 (95% CI = 0.25-0.49) in the HCFD group, both after 28 months (point in time of the last event). The hazard ratio was 0.97, 1-sided 97.5% CI = -∞ to 1.44, p = 0.44.
INTERPRETATION


The results provide no evidence for a life-prolonging effect of HCFD for the whole amyotrophic lateral sclerosis population. However, post hoc analysis revealed a significant survival benefit for the subgroup of fast-progressing patients. ANN NEUROL 2020;87:206-216.",2020,"The confirmatory analysis of the primary outcome survival showed a survival probability of 0.39 (95% CI 0.27-0.51) in the placebo group, and 0.37 (95% CI 0.25-0.49) in the HCFD group, both after 28 months (point in time of the last event).","['Eligible patients', 'German motor neuron disease centers (ALS/MND-NET', 'amyotrophic lateral sclerosis', '201 patients (80 female, 121 male, age 62.4 ±\u200910.8) were included']","['placebo in addition to riluzole', 'placebo', 'HCFD', 'high-caloric nutrition', 'high-caloric fatty diet (HCFD']","['survival time, defined as time to death or time to study cutoff date', 'survival', 'survival benefit', 'survival probability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0085084', 'cui_str': 'Motor System Disease'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",201.0,0.668802,"The confirmatory analysis of the primary outcome survival showed a survival probability of 0.39 (95% CI 0.27-0.51) in the placebo group, and 0.37 (95% CI 0.25-0.49) in the HCFD group, both after 28 months (point in time of the last event).","[{'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'Ludolph', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Dorst', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Dreyhaupt', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Jochen H', 'Initials': 'JH', 'LastName': 'Weishaupt', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kassubek', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Weiland', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Humboldt University of Berlin, Berlin, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Petri', 'Affiliation': 'Department of Neurology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hermann', 'Affiliation': 'Department of Neurology, Dresden University of Technology and German Center for Neurodegenerative Diseases, Dresden, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Emmer', 'Affiliation': 'Department of Neurology, Halle University Hospital, Halle/Saale, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Grosskreutz', 'Affiliation': 'Department of Neurology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Grehl', 'Affiliation': 'Department of Neurology, Bergmannsheil University Hospital, Bochum, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Zeller', 'Affiliation': 'Department of Neurology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Boentert', 'Affiliation': 'Department of Neurology, Institute of Translational Neurology, Münster University Hospital, Münster, Germany.'}, {'ForeName': 'Bertold', 'Initials': 'B', 'LastName': 'Schrank', 'Affiliation': 'Department of Neurology, Deutsche Klinik für Diagnostik HELIOS Clinic of Wiesbaden, Wiesbaden, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Prudlo', 'Affiliation': 'Department of Neurology, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Winkler', 'Affiliation': 'Department of Neurology, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Gorbulev', 'Affiliation': 'Interdisciplinary Center for Clinical Trials, Mainz University Medical Center, Mainz, Germany.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Roselli', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Schuster', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Dupuis', 'Affiliation': 'National Institute of Health and Medical Research, University of Strasbourg, Strasbourg, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25661']
303,32331307,"A Double-Blind Randomized Placebo-Controlled Study Assessing the Safety, Tolerability and Efficacy of a Herbal Medicine Containing Pycnogenol Combined with Papain and  Aloe vera  in the Prevention and Management of Pre-Diabetes.","Background:  Herbal medicines present attractive options to patients with chronic diseases. Undertaking clinical studies with patients presenting with symptomless pre-T2D can lead to significant limitations.  Methods:  A 12-week randomized double-blind placebo-controlled clinical study was conducted that investigated the safety and efficacy of an herbal formulation administered orally for the treatment of pre-type 2 diabetes (pre-T2D).  Results:  A numerically greater proportion of subjects in the interventional arm had impaired fasting glucose (IFG) at week 12 compared to the control arm (71.0% vs. 69.0%, p = 0.75). Fewer participants had impaired glucose tolerance (IGT) at 12 weeks in the intervention arm compared to the control arm (unadjusted 58.3% vs. 66.7%, p = 0.65; adjusting for baseline IGT, p = 0.266). In a subgroup analysis, subjects with a baseline fasting plasma glucose (FPG) level in the range of 6.1-6.9 mmol/L demonstrated a non-significant lower proportion of IFG at week 12 in the intervention arm compared to the control arm (60.0% vs. 41.7% p = 0.343). Total blood cholesterol and triglyceride levels remained unchanged from baseline to week 12 in both treatment groups.  Conclusions:  This study suggests that a polyherbal medicine was not effective for reducing the metabolic markers associated with pre-T2D over a 12-week period. Therefore, larger studies with well-defined endpoints and of longer duration are warranted.",2020,"Fewer participants had impaired glucose tolerance (IGT) at 12 weeks in the intervention arm compared to the control arm (unadjusted 58.3% vs. 66.7%, p = 0.65; adjusting for baseline IGT, p = 0.266).","['patients with chronic diseases', 'Pre-Diabetes', 'pre-type 2 diabetes (pre-T2D']","['Pycnogenol Combined with Papain and  Aloe vera', 'Placebo', 'placebo', 'herbal formulation', 'Herbal Medicine']","['Safety, Tolerability and Efficacy', 'glucose tolerance (IGT', 'fasting glucose (IFG', 'Total blood cholesterol and triglyceride levels', 'safety and efficacy', 'baseline fasting plasma glucose (FPG) level', 'IFG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0072642', 'cui_str': 'Pycnogenol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0030346', 'cui_str': 'Papain'}, {'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.176242,"Fewer participants had impaired glucose tolerance (IGT) at 12 weeks in the intervention arm compared to the control arm (unadjusted 58.3% vs. 66.7%, p = 0.65; adjusting for baseline IGT, p = 0.266).","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Vitetta', 'Affiliation': 'Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Sydney NSW 2006, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Butcher', 'Affiliation': 'WriteSource Medical Pty Ltd., Lane Cove NSW 2066, Australia.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Dal Forno', 'Affiliation': 'Medlab Clinical, Sydney NSW 2015, Australia.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Vitetta', 'Affiliation': 'Medlab Clinical, Sydney NSW 2015, Australia.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Nikov', 'Affiliation': 'Medlab Clinical, Sydney NSW 2015, Australia.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Medlab Clinical, Sydney NSW 2015, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Steels', 'Affiliation': 'Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Sydney NSW 2006, Australia.'}]","Medicines (Basel, Switzerland)",['10.3390/medicines7040022']
304,32331323,Pain Neuroscience Education and Physical Therapeutic Exercise for Patients with Chronic Spinal Pain in Spanish Physiotherapy Primary Care: A Pragmatic Randomized Controlled Trial.,"Chronic musculoskeletal pain affects more than 20% of the population, leading to high health care overload and huge spending. The prevalence is increasing and negatively affects both physical and mental health, being one of the leading causes of disability. The most common location is the spine. Most treatments used in the Public Health Services are passive (pharmacological and invasive) and do not comply with current clinical guidelines, which recommend treating pain in primary care (PC) with education and exercise as the first-line treatments. A randomized multicentre clinical trial has been carried out in 12 PC centres. The experimental group (EG) conducted a program of pain neuroscience education (6 sessions, 10 h) and group physical exercise with playful, dual-tasking, and socialization-promoting components (18 sessions in 6 weeks, 18 h), and the control group performed the usual physiotherapy care performed in PC. The experimental treatment improved quality of life ( d  = 1.8 in physical component summary), catastrophism ( d  = 1.7), kinesiophobia ( d  = 1.8), central sensitization ( d  = 1.4), disability ( d  = 1.4), pain intensity ( d  = 3.3), and pressure pain thresholds ( d  = 2). Differences between the groups ( p  < 0.001) were clinically relevant in favour of the EG. Improvements post-intervention (week 11) were maintained at six months. The experimental treatment generates high levels of satisfaction.",2020,"The experimental treatment improved quality of life ( d  = 1.8 in physical component summary), catastrophism ( d  = 1.7), kinesiophobia ( d  = 1.8), central sensitization ( d  = 1.4), disability ( d  = 1.4), pain intensity ( d  = 3.3), and pressure pain thresholds ( d  = 2).","['Patients with Chronic Spinal Pain in Spanish Physiotherapy Primary Care', '12 PC centres']","['program of pain neuroscience education (6 sessions, 10 h) and group physical exercise with playful, dual-tasking, and socialization-promoting components', 'control group performed the usual physiotherapy care performed in PC', 'Pain Neuroscience Education and Physical Therapeutic Exercise']","['pain intensity', 'Chronic musculoskeletal pain', 'pressure pain thresholds', 'central sensitization', 'disability', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0423673', 'cui_str': 'Pain in spine'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0543286,"The experimental treatment improved quality of life ( d  = 1.8 in physical component summary), catastrophism ( d  = 1.7), kinesiophobia ( d  = 1.8), central sensitization ( d  = 1.4), disability ( d  = 1.4), pain intensity ( d  = 3.3), and pressure pain thresholds ( d  = 2).","[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Galan-Martin', 'Affiliation': 'Unit for Active Coping Strategies for Pain in Primary Care, East-Valladolid Primary Care Management, Castilla and León Public Health System (Sacyl), 47011 Valladolid, Spain.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Montero-Cuadrado', 'Affiliation': 'Unit for Active Coping Strategies for Pain in Primary Care, East-Valladolid Primary Care Management, Castilla and León Public Health System (Sacyl), 47011 Valladolid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Lluch-Girbes', 'Affiliation': 'Department of Physical Therapy, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'María Carmen', 'Initials': 'MC', 'LastName': 'Coca-López', 'Affiliation': 'Castilla and León Regional Centre of Sports Medicine, (Sacyl), 47011 Valladolid, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Mayo-Iscar', 'Affiliation': 'Department of Statistics and Operational Research and IMUVA, University of Valladolid, 47005 Valladolid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cuesta-Vargas', 'Affiliation': 'Department of Physiotherapy, Faculty of Heath Sciences, University of Malaga, 19071 Málaga, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9041201']
305,32331341,"Clinical Effectiveness of a Combination of Black Elder Berries, Violet Herb, and Calendula Flowers in Chronic Obstructive Pulmonary Disease: The Results of a Double-Blinded Placebo-Controlled Study.","Chronic obstructive pulmonary disease (COPD) is a multifactorial disease, in which systemic inflammation plays a key role. This 6-month randomized double-blinded placebo-controlled study evaluates the possible effect of natural preparation Inflaminat on clinical symptoms of COPD, indicators of respiratory function, and exacerbation frequency in 60 patients with moderate severity of COPD. Inflaminat is a combination of natural ingredients black elder ( Sambucus nigra  L.) berries, violet ( Viola tricolor  L.) herb, and calendula ( Calendula officinalis  L.) flowers. The preparation has been previously demonstrated to possess anticytokine and anti-inflammatory effects in experimental studies. In present study, COPD dynamics were evaluated by means of BCSS (Breathlessness, Cough, and Sputum Scale) and spirometry tests. It was shown that 6-months Inflaminat administration led to significant decrease of BCSS points from 3.0 ± 0.6 to 1.9 ± 0.7, ( p  = 0.002) as well as significant increase of FEV1 from 66 ± 18% to 73 ± 17%, ( p  = 0.042); there were no beneficial dynamics in placebo group. Side effects associated with preparation administration were not identified. The results of the study suggest that Inflaminat may be employed in treatment of patients with moderate severity of COPD, since it has a positive effect on COPD symptoms according BCSS and indicators of respiratory function FEV1.",2020,"It was shown that 6-months Inflaminat administration led to significant decrease of BCSS points from 3.0 ± 0.6 to 1.9 ± 0.7, ( p  = 0.002) as well as significant increase of FEV1 from 66 ± 18% to 73 ± 17%, ( p  = 0.042); there were no beneficial dynamics in placebo group.","['Chronic Obstructive Pulmonary Disease', '60 patients with moderate severity of COPD', 'patients with moderate severity of COPD', 'Chronic obstructive pulmonary disease (COPD']","['placebo', 'Placebo', 'Black Elder Berries, Violet Herb, and Calendula Flowers']","['clinical symptoms of COPD, indicators of respiratory function, and exacerbation frequency', 'BCSS (Breathlessness, Cough, and Sputum Scale) and spirometry tests', 'BCSS points']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0331059', 'cui_str': 'Sambucus nigra'}, {'cui': 'C0005135', 'cui_str': 'Berry'}, {'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C2911923', 'cui_str': 'Calendula officinalis flower extract'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}]",60.0,0.358657,"It was shown that 6-months Inflaminat administration led to significant decrease of BCSS points from 3.0 ± 0.6 to 1.9 ± 0.7, ( p  = 0.002) as well as significant increase of FEV1 from 66 ± 18% to 73 ± 17%, ( p  = 0.042); there were no beneficial dynamics in placebo group.","[{'ForeName': 'Tatiana V', 'Initials': 'TV', 'LastName': 'Kirichenko', 'Affiliation': 'Laboratory of Infection Pathology and Molecular Microecology, Institute of Human Morphology, 117418 Moscow, Russia.'}, {'ForeName': 'Igor A', 'Initials': 'IA', 'LastName': 'Sobenin', 'Affiliation': 'Laboratory of Infection Pathology and Molecular Microecology, Institute of Human Morphology, 117418 Moscow, Russia.'}, {'ForeName': 'Yuliya V', 'Initials': 'YV', 'LastName': 'Markina', 'Affiliation': 'Laboratory of Infection Pathology and Molecular Microecology, Institute of Human Morphology, 117418 Moscow, Russia.'}, {'ForeName': 'Elena V', 'Initials': 'EV', 'LastName': 'Gerasimova', 'Affiliation': 'Department of Systemic Rheumatic Diseases, V.A. Nasonova Institute of Rheumatology, 115522 Moscow, Russia.'}, {'ForeName': 'Andrey V', 'Initials': 'AV', 'LastName': 'Grechko', 'Affiliation': 'Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology, 109240 Moscow, Russia.'}, {'ForeName': 'Dmitry A', 'Initials': 'DA', 'LastName': 'Kashirskikh', 'Affiliation': 'Laboratory of Angiopathology, Institute of General Pathology and Pathophysiology, 125315 Moscow, Russia.'}, {'ForeName': 'Elena B', 'Initials': 'EB', 'LastName': 'Romanenko', 'Affiliation': 'Department of Molecular Basis of Ontogenesis, Belozersky Institute of Physical and Chemical Biology, Moscow State University, 119234 Moscow, Russia.'}, {'ForeName': 'Wei-Kai', 'Initials': 'WK', 'LastName': 'Wu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Bei-Hu Branch, Taipei 108, Taiwan.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Orekhov', 'Affiliation': 'Laboratory of Infection Pathology and Molecular Microecology, Institute of Human Morphology, 117418 Moscow, Russia.'}]",Biology,['10.3390/biology9040083']
306,32332590,Effect of cognitive-behavioral therapy with music therapy in reducing physics test anxiety among students as measured by generalized test anxiety scale.,"BACKGROUND


The study determined the effect of cognitive-behavioral therapy (CBT) with music in reducing physics test anxiety among secondary school students as measured by generalized test anxiety scale.
METHODS


Pre-test post-test randomized control trial experimental design was adopted in this study. A total of 83 senior secondary students including male (n = 46) and female (n = 37) from sampled secondary schools in Enugu State, Nigeria, who met the inclusion criteria constituted participants for the study. A demographic questionnaire and a 48-item generalized test anxiety scale were used for data collection for the study. Subjects were randomized into treatment and control groups. The treatment group was exposed to a 12-week CBT-music program. Thereafter, the participants in the treatment group were evaluated at 3 time points. Data collected were analyzed using repeated measures analysis of variance.
RESULTS


The participants who were exposed to CBT-music intervention program significantly had lower test anxiety scores at the post-treatment than the participants in the control group. Furthermore, the test anxiety scores of the participants in the CBT-music group were significantly lower than those in the control group at the follow-up measure. Thus, the results showed a significant effect of CBT with music in reducing physics test anxiety among secondary school students.
CONCLUSION


We concluded that CBT-music program has a significant benefit in improving the management of physics test anxiety among secondary school students.",2020,"Furthermore, the test anxiety scores of the participants in the CBT-music group were significantly lower than those in the control group at the follow-up measure.","['83 senior secondary students including male (n\u200a=\u200a46) and female (n\u200a=\u200a37) from sampled secondary schools in Enugu State, Nigeria, who met the inclusion criteria constituted participants for the study', 'secondary school students']","['CBT-music intervention program', 'CBT-music program', 'cognitive-behavioral therapy with music therapy', 'CBT', 'cognitive-behavioral therapy (CBT']","['generalized test anxiety scale', 'test anxiety scores', 'physics test anxiety']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0039577', 'cui_str': 'Test Anxiety Questionnaire'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031837', 'cui_str': 'Physics'}]",83.0,0.0210617,"Furthermore, the test anxiety scores of the participants in the CBT-music group were significantly lower than those in the control group at the follow-up measure.","[{'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Ugwuanyi', 'Affiliation': 'Postdoctoral fellow, School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Moses O', 'Initials': 'MO', 'LastName': 'Ede', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Charity N', 'Initials': 'CN', 'LastName': 'Onyishi', 'Affiliation': ''}, {'ForeName': 'Osita V', 'Initials': 'OV', 'LastName': 'Ossai', 'Affiliation': ''}, {'ForeName': 'Edith N', 'Initials': 'EN', 'LastName': 'Nwokenna', 'Affiliation': 'Department of Art Education, Faculty of Education, University of Nigeria, Nsukka.'}, {'ForeName': 'Lauretta C', 'Initials': 'LC', 'LastName': 'Obikwelu', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Amaka', 'Initials': 'A', 'LastName': 'Ikechukwu-Ilomuanya', 'Affiliation': ''}, {'ForeName': 'Chijioke V', 'Initials': 'CV', 'LastName': 'Amoke', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Agnes O', 'Initials': 'AO', 'LastName': 'Okeke', 'Affiliation': 'Postdoctoral fellow, School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Catherine U', 'Initials': 'CU', 'LastName': 'Ene', 'Affiliation': 'Postdoctoral fellow, School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Edmund E', 'Initials': 'EE', 'LastName': 'Offordile', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Lilian C', 'Initials': 'LC', 'LastName': 'Ozoemena', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Maduka L', 'Initials': 'ML', 'LastName': 'Nweke', 'Affiliation': 'Department of Physiology, Faculty of Basic Medical Sciences, College of Medicine, University of Nigeria, Ituku-Ozalla, Enugu State, Nigeria.'}]",Medicine,['10.1097/MD.0000000000016406']
307,31400516,Design of the PACIFIC study: A randomized controlled trial evaluating a novel treatment for adults with overweight and obesity.,"The majority of adults in the United States have overweight or obesity which is associated with significant health and psychological consequences. Behavioral Weight Loss (BWL) is the current gold-standard weight-loss program for adults but recidivism rates continue to be disturbingly high. Given the health consequences of excess weight and the lack of long-term effectiveness of BWL, it is important to identify novel weight-loss programs. We developed the ROC (Regulation of Cues) program to reduce overeating through improvement in sensitivity to appetitive cues and decreased responsivity to external food cues. This study is a 4-arm randomized control trial designed to evaluate the efficacy of ROC, ROC combined with BWL, BWL alone and an active comparator over 24 months. Study recruitment completed in November 2017. Two hundred and seventy-one participants were randomized (mean age = 46.97 years; 82% female, mean BMI = 34.59; 20% Hispanic) and assessments were conducted at baseline, mid-treatment (6 months) and post-treatment (12 months). At this time, participants are completing 6- (18 months) and 12-month (24 months) follow-ups. Targeting novel mechanisms is critically important to improve weight-loss programs. Through this trial, we hope to identify treatments for adults with overweight and obesity to facilitate long-term weight loss and improved health.",2019,We developed the ROC (Regulation of Cues) program to reduce overeating through improvement in sensitivity to appetitive cues and decreased responsivity to external food cues.,"['adults with overweight and obesity', 'Two hundred and seventy-one participants were randomized (mean age\u202f=\u202f46.97\u202fyears; 82% female, mean BMI\u202f=\u202f34.59; 20% Hispanic', 'adults with overweight and obesity to facilitate long-term weight loss and improved health']","['ROC, ROC combined with BWL, BWL alone']",['Behavioral Weight Loss (BWL'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",271.0,0.0641581,We developed the ROC (Regulation of Cues) program to reduce overeating through improvement in sensitivity to appetitive cues and decreased responsivity to external food cues.,"[{'ForeName': 'Kerri N', 'Initials': 'KN', 'LastName': 'Boutelle', 'Affiliation': 'Department of Pediatrics, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA; Department of Family Medicine and Public Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA. Electronic address: kboutelle@ucsd.edu.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Eichen', 'Affiliation': 'Department of Pediatrics, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA.'}, {'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry, University of Minnesota, F282/2A West 2450, Riverside Ave, Minneapolis, MN 55454, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Rock', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA.'}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University, School of Public Health, 121 South Main Street, Box G-S121-3, Providence, RI 02912-G, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105824']
308,31419605,"Rationale, design, and baseline data for a multicenter randomized clinical trial comparing depression screening strategies after acute coronary syndrome: The comparison of depression identification after acute Coronary Syndromes-Quality of Life and Cost Outcomes (CODIACS-QOL) trial.","BACKGROUND


Elevated depressive symptoms among survivors of acute coronary syndromes (ACS) confer recurrent cardiovascular events and mortality, worse quality of life, and higher healthcare costs. While multiple scientific groups advise routine depression screening for ACS survivors, no randomized trials exist to inform this screening recommendation. We aimed to assess the effect of screening for depression on change in quality of life over 18 months among ACS patients.
METHODS


The Comparison of Depression Identification after Acute Coronary Syndrome on Quality of Life and Cost Outcomes (CODIACS-QoL) trial is a pragmatic, 3-arm trial that randomized ACS patients to 1) systematic depression screening using the 8-item Patient Health Questionnaire (PHQ-8) and if positive screen (PHQ-8 ≥ 10), notification of primary care providers (PCPs) and invitation to participate in centralized, patient-preference, stepped depression care (Screen, Notify, and Treat, N = 499); 2) systematic depression screening and PCP notification only (Screen and Notify, N = 501); and 3) usual care (No Screen, N = 500). Adults hospitalized for ACS in the previous 2-12 months without prior history of depression were eligible for participation. Key outcomes will be quality-adjusted life years (primary), cost of health care utilization, and depression-free days across 18 months.
RESULTS


A total of 1500 patients were randomized in the CODIACS-QOL trial (28.3% women; 16.3% Hispanic; mean age 65.9 (11.5) years). Only 7% of ACS survivors had elevated depressive symptoms.
CONCLUSIONS


Using a novel randomization schema and pragmatic design principles, the CODIACS-QoL trial achieved its enrollment target. Eventual results of this trial will inform future depression screening recommendations in cardiac patients.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT01993017).",2019,"Only 7% of ACS survivors had elevated depressive symptoms.
","['ACS patients', 'Adults hospitalized for ACS in the previous 2-12\u202fmonths without prior history of depression were eligible for participation', 'cardiac patients', 'after acute coronary syndrome', 'A total of 1500 patients were randomized in the CODIACS-QOL trial (28.3% women; 16.3% Hispanic; mean age 65.9 (11.5) years', 'survivors of acute coronary syndromes (ACS']","['depression screening strategies', 'positive screen (PHQ-8\u202f≥\u202f10), notification of primary care providers (PCPs) and invitation to participate in centralized, patient-preference, stepped depression care (Screen, Notify, and Treat, N\u202f=\u202f499); 2) systematic depression screening and PCP notification only (Screen and Notify, N\u202f=\u202f501); and 3) usual care (No Screen, N\u202f=\u202f500']","['quality-adjusted life years (primary), cost of health care utilization, and depression-free days across 18\u202fmonths', 'quality of life', 'elevated depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0455503', 'cui_str': 'H/O: depression'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0740218', 'cui_str': 'Depression screening (procedure)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}]","[{'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",1500.0,0.252491,"Only 7% of ACS survivors had elevated depressive symptoms.
","[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Moise', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America. Electronic address: nm2562@cumc.columbia.edu.'}, {'ForeName': 'Karina W', 'Initials': 'KW', 'LastName': 'Davidson', 'Affiliation': 'Northwell Health, New York, NY, United States of America.'}, {'ForeName': 'Ying Kuen K', 'Initials': 'YKK', 'LastName': 'Cheung', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Gregory N', 'Initials': 'GN', 'LastName': 'Clarke', 'Affiliation': 'Kaiser Permanente Northwest, Portland, OR, United States of America.'}, {'ForeName': 'Rowena J', 'Initials': 'RJ', 'LastName': 'Dolor', 'Affiliation': 'Duke Primary Care Research Consortium, Durham, NC, United States of America.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Duer-Hefele', 'Affiliation': 'Northwell Health, New York, NY, United States of America.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Ladapo', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': 'HealthPartners, Minneapolis, MN, United States of America.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'St Onge', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Parsons', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Retuerto', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Schmit', 'Affiliation': 'Duke Primary Care Research Consortium, Durham, NC, United States of America.'}, {'ForeName': 'Anusorn', 'Initials': 'A', 'LastName': 'Thanataveerat', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Kronish', 'Affiliation': 'Columbia University Medical Center, New York, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105826']
309,31419607,Reducing sexual health risks and substance use in the prenatal setting: A study protocol for a randomized controlled trial.,"Sexually transmitted infections (STIs) are at a record high in the United States, and STI risk is a critical and costly public health concern for childbearing women. STIs can lead to a number of serious health risks including premature birth, low birth weight, ectopic pregnancy, and fetal death. Similarly, there has been a dramatic increase in substance use during pregnancy, leading to complications during pregnancy and poorer birth outcomes. Women who misuse substances are disproportionately more likely to engage in risky sexual behaviors that can result in STIs. The proposed study will test whether the Health Check-Up for Expectant Moms (HCEM), a computer-delivered brief intervention that simultaneously targets STI risk and alcohol/illicit drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care. The study is a two-group, randomized controlled trial in which a diverse sample of 250 pregnant women will be recruited from prenatal care clinics and assigned to either (a) a computer-delivered, single-session brief intervention plus two booster sessions); or (b) a computer-delivered control condition. Follow-up assessments will occur at 2 and 6 months from baseline, and at 6 weeks postpartum. Our objective measures include STI incidence and birth outcomes. The results of this trial will fill a critical gap and provide much-needed data on the efficacy, costs, and resource utilization of a practical computer-delivered, brief motivational intervention tailored to reach high-risk women during pregnancy and extending impact to postpartum.",2019,"The proposed study will test whether the Health Check-Up for Expectant Moms (HCEM), a computer-delivered brief intervention that simultaneously targets STI risk and alcohol/illicit drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care.","['childbearing women', 'pregnant women seeking prenatal care', '250 pregnant women will be recruited from prenatal care clinics and assigned to either (a) a']","['computer-delivered, single-session brief intervention plus two booster sessions); or (b) a computer-delivered control condition', 'Health Check-Up for Expectant Moms (HCEM']","['risky sexual behaviors', 'STI incidence and birth outcomes', 'sexual health risks']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",250.0,0.0740378,"The proposed study will test whether the Health Check-Up for Expectant Moms (HCEM), a computer-delivered brief intervention that simultaneously targets STI risk and alcohol/illicit drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care.","[{'ForeName': 'Golfo', 'Initials': 'G', 'LastName': 'Tzilos Wernette', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI 48104, United States of America. Electronic address: gtzilos@med.umich.edu.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Plegue', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI 48104, United States of America.'}, {'ForeName': 'Okeoma', 'Initials': 'O', 'LastName': 'Mmeje', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI 48104, United States of America.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI 48104, United States of America.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Countryman', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI 48104, United States of America.'}, {'ForeName': 'Quyen', 'Initials': 'Q', 'LastName': 'Ngo', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI 48109, United States of America.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Prosser', 'Affiliation': 'Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, MI 48104, United States of America.'}, {'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Zlotnick', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University, Providence, RI 02906, United States of America; Women and Infants Hospital, Providence, RI 02906, United States of America; Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105827']
310,31034597,"Prognostic accuracy of patients, caregivers, and oncologists in advanced cancer.","BACKGROUND


In caring for patients with advanced cancer, accurate estimation of survival is important for clinical decision making. The purpose of this study was to assess the accuracy of 2-year survival probabilities estimated by oncologists, patients, and caregivers and to identify demographic and clinical factors associated with prognostic accuracy.
METHODS


This was a secondary observational analysis of data obtained from a cluster randomized controlled trial. Participants included 38 oncologists, 263 patients with advanced nonhematologic cancer, and 193 of their caregivers from clinics in Sacramento and Western New York. Discrimination within each group (oncologists, patients, caregivers) was evaluated using the C statistic, whereas calibration was assessed by comparing observed to predicted 2-year mortality using the chi-square statistic.
RESULTS


The median survival from study entry was 18 months, and 41.8% of patients survived for 2 years. C statistics for oncologists, patients, and caregivers were 0.81 (95% CI, 0.76-0.86), 0.62 (95% CI, 0.55-0.68), and 0.72 (95% CI, 0.65-0.78), respectively; oncologists' predictions were better than the predictions of both patients (P = .001) and caregivers (P = .03). Oncologists also had superior calibration: their predictions of 2-year survival were similar to actual survival (P = .17), whereas patients' (P = .0001) and caregivers' (P = .003) predictions diverged significantly from actual survival. Although most oncologists' predictions were classified as realistic (62.0%), approximately one-half of patients' and caregivers' predictions (50.0% and 46.0%, respectively) were unduly optimistic. Among patients, nonwhite race and higher levels of social well-being predicted undue optimism (P < .05).
CONCLUSIONS


Compared with oncologists, patients and caregivers displayed inferior prognostic discrimination, and their predictions were poorly calibrated, primarily because of overoptimism.",2019,"Among patients, nonwhite race and higher levels of social well-being predicted undue optimism (P < .05).
","['patients, caregivers, and oncologists in advanced cancer', 'Participants included 38 oncologists, 263 patients with advanced nonhematologic cancer, and 193 of their caregivers from clinics in Sacramento and Western New York', 'patients with advanced cancer']",[],"['accuracy of 2-year survival probabilities', '2-year survival', 'actual survival', 'median survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0027976', 'cui_str': 'New York'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",263.0,0.159178,"Among patients, nonwhite race and higher levels of social well-being predicted undue optimism (P < .05).
","[{'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Malhotra', 'Affiliation': 'Department of Internal Medicine, University of California at Davis, Sacramento, California.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Fenton', 'Affiliation': 'Department of Family and Community Medicine, University of California at Davis, Sacramento, California.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Guibo', 'Initials': 'G', 'LastName': 'Xing', 'Affiliation': 'Center for Healthcare Policy and Research, University of California at Davis, Sacramento, California.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': 'Center for Healthcare Policy and Research, University of California at Davis, Sacramento, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoerger', 'Affiliation': 'Department of Psychology, Tulane University, New Orleans, Louisiana.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gramling', 'Affiliation': 'Division of Palliative Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Kravitz', 'Affiliation': 'Center for Healthcare Policy and Research, University of California at Davis, Sacramento, California.'}]",Cancer,['10.1002/cncr.32127']
311,31937527,Lay Health Coaching to Increase Appropriate Inhaler Use in COPD: A Randomized Controlled Trial.,"PURPOSE


Poor adherence to medications is more prevalent for chronic obstructive pulmonary disease (COPD) than for other chronic conditions and is associated with unfavorable health outcomes. Few interventions have successfully improved adherence for COPD medications; none of these use unlicensed health care personnel. We explored the efficacy of lay health coaches to improve inhaler adherence and technique.
METHODS


Within a randomized controlled trial, we recruited English- and Spanish-speaking patients with moderate to severe COPD from urban, public primary care clinics serving a low-income, predominantly African American population. Participants were randomized to receive 9 months of health coaching or usual care. Outcome measures included self-reported adherence to inhaled controller medications in the past 7 days and observed technique for all inhalers. We used generalized linear models, controlling for baseline values and clustering by site.
RESULTS


Baseline adherence and inhaler technique were uniformly poor and did not differ by study arm. At 9 months, health-coached patients reported a greater number of days of adherence compared with usual care patients (6.4 vs 5.5 days; adjusted  P  = .02) and were more likely to have used their controller inhalers as prescribed for 5 of the last 7 days (90% vs 69%; adjusted  P  = .008). They were more than 3 times as likely to demonstrate perfect technique for all inhaler devices (24% vs 7%; adjusted  P  = .01) and mastery of essential steps (40% vs 11%; adjusted  P  <.001).
CONCLUSIONS


Health coaching may provide a scalable model that can improve care for people living with COPD.",2020,"At 9 months, health-coached patients reported a greater number of days of adherence compared with usual care patients (6.4 vs 5.5 days; adjusted  P  = .02) and were more likely to have used their controller inhalers as prescribed for 5 of the last 7 days (90% vs 69%; adjusted  P  = .008).","['chronic obstructive pulmonary disease (COPD', 'people living with COPD', 'COPD', 'recruited English- and Spanish-speaking patients with moderate to severe COPD from urban, public primary care clinics serving a low-income, predominantly African American population']",['health coaching or usual care'],"['self-reported adherence to inhaled controller medications in the past 7 days and observed technique for all inhalers', 'number of days of adherence', 'mastery of essential steps', 'Baseline adherence and inhaler technique']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205224', 'cui_str': 'Essential (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}]",,0.123517,"At 9 months, health-coached patients reported a greater number of days of adherence compared with usual care patients (6.4 vs 5.5 days; adjusted  P  = .02) and were more likely to have used their controller inhalers as prescribed for 5 of the last 7 days (90% vs 69%; adjusted  P  = .008).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Willard-Grace', 'Affiliation': 'Department of Family and Community Medicine, University of California San Francisco, San Francisco, California Rachel.Willard@ucsf.edu.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Chirinos', 'Affiliation': 'Department of Family and Community Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': 'Department of Family and Community Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'DeVore', 'Affiliation': 'Department of Family and Community Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'Department of Family and Community Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hessler', 'Affiliation': 'Department of Family and Community Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tsao', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Su', 'Affiliation': 'Department of Medicine: Pulmonology, Critical Care, Allergy and Sleep Medicine Program, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Thom', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Palo Alto, California.'}]",Annals of family medicine,['10.1370/afm.2461']
312,31937528,Peer-Delivered Cognitive Behavioral Training to Improve Functioning in Patients With Diabetes: A Cluster-Randomized Trial.,"PURPOSE


Cognitive behavioral therapy (CBT)-based programs delivered by trained community members could improve functioning and pain in individuals who lack access to such programs. We tested the effectiveness of a peer-delivered diabetes self-management program integrating CBT principles in improving physical activity, functional status, pain, quality of life (QOL), and health outcomes in individuals with diabetes and chronic pain.
METHODS


In this community-based, cluster-randomized controlled trial, intervention participants received a 3-month, peer-delivered, telephone-administered program. Attention control participants received a peer-delivered general health advice program. Outcomes were changes in functional status and pain (Western Ontario and McMaster Universities Osteoarthritis Index), QOL (Short Form 12), and physiologic measures (hemoglobin A 1c , systolic blood pressure, body mass index); physical activity was the explanatory outcome.
RESULTS


Of 195 participants with follow-up data, 80% were women, 96% African Americans, 74% had annual income <$20,000, and 64% had high school education or less. At follow-up, compared with controls, intervention participants had greater improvement in functional status (-10 ± 13 vs -5 ± 18,  P  = .002), pain (-10.5 ± 19 vs -4.8 ± 21,  P  = .01), and QOL (4.8 ± 8.8 vs 3.8 ± 8.8,  P  = .001). Physiologic measures did not change significantly in either group. At 3 months, a greater proportion of intervention than control participants reported no pain or did other forms of exercise when pain prevented them from walking for exercise.
CONCLUSION


This peer-delivered CBT-based intervention improved functioning, pain, QOL, and self-reported physical activity despite pain in individuals with diabetes and chronic pain. Trained community members can deliver effective CBT-based interventions in rural and under-resourced communities.",2020,"This peer-delivered CBT-based intervention improved functioning, pain, QOL, and self-reported physical activity despite pain in individuals with diabetes and chronic pain.","[' 80% were women, 96% African Americans, 74% had annual income <$20,000, and 64% had high school education or less', 'individuals who lack access to such programs', 'individuals with diabetes and chronic pain', 'Patients With Diabetes', '195 participants with follow-up data']","['peer-delivered diabetes self-management program integrating CBT principles', 'peer-delivered general health advice program', 'telephone-administered program', 'Cognitive behavioral therapy (CBT)-based programs', 'Peer-Delivered Cognitive Behavioral Training']","['physical activity, functional status, pain, quality of life (QOL), and health outcomes', 'functioning and pain', 'functional status and pain (Western Ontario and McMaster Universities Osteoarthritis Index), QOL (Short Form 12), and physiologic measures (hemoglobin A 1c , systolic blood pressure, body mass index); physical activity', 'Physiologic measures', 'pain', 'functioning, pain, QOL, and self-reported physical activity despite pain', 'functional status']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",195.0,0.0609482,"This peer-delivered CBT-based intervention improved functioning, pain, QOL, and self-reported physical activity despite pain in individuals with diabetes and chronic pain.","[{'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Andreae', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Lynn J', 'Initials': 'LJ', 'LastName': 'Andreae', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Joshua S', 'Initials': 'JS', 'LastName': 'Richman', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Cherrington', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Monika M', 'Initials': 'MM', 'LastName': 'Safford', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, New York mms9024@med.cornell.edu.'}]",Annals of family medicine,['10.1370/afm.2469']
313,32331356,Connectivity of Real-Time Video Counselling Versus Telephone Counselling for Smoking Cessation in Rural and Remote Areas: An Exploratory Study.,"This study compared the connectivity of video sessions to telephone sessions delivered to smokers in rural areas and whether remoteness and video app (video only) were associated with the connectivity of video or telephone sessions. Participants were recruited into a randomised trial where two arms offered smoking cessation counselling via: (a) real-time video communication software (201 participants) or (b) telephone (229 participants). Participants were offered up to six video or telephone sessions and the connectivity of each session was recorded. A total of 456 video sessions and 606 telephone sessions were completed. There was adequate connectivity of the video intervention in terms of no echoing noise (97.8%), no loss of internet connection during the session (88.6%), no difficulty hearing the participant (88.4%) and no difficulty seeing the participant (87.5%). In more than 94% of telephone sessions, there was no echoing noise, no difficulty hearing the participant and no loss of telephone line connection. Video sessions had significantly greater odds of experiencing connectivity difficulties than telephone sessions in relation to connecting to the participant at the start (odds ratio, OR = 5.13, 95% confidence interval, CI 1.88-14.00), loss of connection during the session (OR = 11.84, 95% CI 4.80-29.22) and hearing the participant (OR = 2.53, 95% CI 1.41-4.55). There were no significant associations between remoteness and video app and connectivity difficulties in the video or telephone sessions. Real-time video sessions are a feasible option for smoking cessation providers to provide support in rural areas.",2020,"Video sessions had significantly greater odds of experiencing connectivity difficulties than telephone sessions in relation to connecting to the participant at the start (odds ratio, OR = 5.13, 95% confidence interval, CI 1.88-14.00), loss of connection during the session (OR = 11.84, 95% CI 4.80-29.22) and hearing the participant (OR = 2.53, 95% CI 1.41-4.55).","['229 participants', 'Smoking Cessation in Rural and Remote Areas']","['Real-Time Video Counselling Versus Telephone Counselling', 'smoking cessation counselling via: (a) real-time video communication software (201 participants) or (b) telephone']","['loss of connection', 'no loss of internet connection', 'remoteness and video app and connectivity difficulties', 'experiencing connectivity difficulties']","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.0278314,"Video sessions had significantly greater odds of experiencing connectivity difficulties than telephone sessions in relation to connecting to the participant at the start (odds ratio, OR = 5.13, 95% confidence interval, CI 1.88-14.00), loss of connection during the session (OR = 11.84, 95% CI 4.80-29.22) and hearing the participant (OR = 2.53, 95% CI 1.41-4.55).","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Byaruhanga', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287, Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17082891']
314,32331366,"Effects of the Healthy Children, Healthy Families, Healthy Communities Program for Obesity Prevention among Vulnerable Children: A Cluster-Randomized Controlled Trial.","Background : We aimed to examine whether the Healthy Children, Healthy Families, and Healthy Communities Program, consisting of multi-level strategies for obesity prevention tailoring the context of socioeconomically vulnerable children based on an ecological perspective, would be effective on improving their healthy lifestyle behaviors and obesity status.  Methods : Participants were 104 children (and 59 parents) enrolled in public welfare systems in Seoul, South Korea. Based on a cluster-randomized controlled trial (no. ISRCTN11347525), eight centers were randomly assigned to intervention (four centers, 49 children, 27 parents) versus control groups (four centers, 55 children, 32 parents). Multi-level interventions of child-, parent-, and center-level strategies were conducted for 12 weeks. Children's healthy lifestyle behaviors and obesity status were assessed as daily recommended levels and body mass index ≥85th percentile, respectively. Parents' parenting behaviors were measured by the Family Nutrition and Physical Activity scale.  Results : Compared to the control group, the intervention group showed significant improvements in total composite scores of healthy-lifestyle behaviors-including 60-min of moderate physical activity-but not in obesity status among children. Moreover, the intervention group showed significant improvements in parenting behaviors among parents.  Conclusion : The multi-level strategies for obesity prevention based on an ecological perspective may be effective for promoting healthy lifestyles among socioeconomically vulnerable children.",2020,"Compared to the control group, the intervention group showed significant improvements in total composite scores of healthy-lifestyle behaviors-including 60-min of moderate physical activity-but not in obesity status among children.","['Participants were 104 children (and 59 parents) enrolled in public welfare systems in Seoul, South Korea', 'socioeconomically vulnerable children', 'Healthy Children, Healthy Families, and Healthy Communities Program', 'Healthy Children, Healthy Families, Healthy Communities Program for Obesity Prevention among Vulnerable Children']",[],"['total composite scores of healthy-lifestyle behaviors-including 60-min of moderate physical activity', 'Family Nutrition and Physical Activity scale', 'parenting behaviors', ""Children's healthy lifestyle behaviors and obesity status"", ""Parents' parenting behaviors""]","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]",104.0,0.03545,"Compared to the control group, the intervention group showed significant improvements in total composite scores of healthy-lifestyle behaviors-including 60-min of moderate physical activity-but not in obesity status among children.","[{'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Choo', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Hwa-Mi', 'Initials': 'HM', 'LastName': 'Yang', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Sae-Young', 'Initials': 'SY', 'LastName': 'Jae', 'Affiliation': 'Department of Sport Science, University of Seoul, Seoul 02504, Korea.'}, {'ForeName': 'Hye-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Jihyun', 'Initials': 'J', 'LastName': 'You', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Juneyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, College of Medicine, Korea University, Seoul 02841, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17082895']
315,32145674,"A double-blind, randomized, sham-controlled study of cranial electrotherapy stimulation as an add-on treatment for tic disorders in children and adolescents.","AIM


The aim of this study was to determine the efficacy and safety of cranial electrotherapy stimulation (CES) as an add-on treatment for TD.
METHODS


A randomized, double-blind, sham-controlled trial was conducted at an outpatient, single-center academic setting. A total of 62 patients aged 6-17 years with TD and lack of clinical response to 4 weeks' pharmacotherapy were enrolled. Patients were divided randomly into 2 groups and given 4 weeks' treatment, including 30 min sessions of active CES (500 μA-2 mA) or sham CES (lower than 100 μA) per day for 40 d on weekdays. Change in Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression-severity of illness-severity (CGI-S) and Hamilton Anxiety Scale-14 items (HAMA-14) were performed at baseline, week 2, week 4. Adverse events (AEs) were also evaluated.
RESULTS


53 patients (34 males and 9 females) completed the trial, including 29 in the active CES group and 24 in the sham CES group. Both groups showed clinical improvement in tic severities compared to baseline respectively at week 4. Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
CONCLUSION


Four-week's treatment of CES for children and adolescents with TD is effective and safe, but the improvement for tic severity may be related to placebo effect.",2020,"Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
","[""62 patients aged 6-17 years with TD and lack of clinical response to 4 weeks' pharmacotherapy were enrolled"", 'tic disorders in children and adolescents', '53 patients (34 males and 9 females) completed the trial, including 29 in the active CES group and 24 in the sham CES group']","['cranial electrotherapy stimulation', 'active CES', 'cranial electrotherapy stimulation (CES', 'active CES (500\u2009μA-2\u2009mA) or sham CES']","['clinical improvement in tic severities', 'Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression-severity of illness-severity (CGI-S) and Hamilton Anxiety', 'efficacy and safety', 'Adverse events (AEs', 'YGTSS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder (disorder)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",62.0,0.38816,"Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
","[{'ForeName': 'Wen-Jun', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: wenjun104@126.com.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: fgx995@163.com.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: caimin@fmmu.edu.cn.""}, {'ForeName': 'Yi-Huan', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: 182368179@qq.com.""}, {'ForeName': 'Cui-Hong', 'Initials': 'CH', 'LastName': 'Zhou', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: zch4610@126.com.""}, {'ForeName': 'Hua-Ning', 'Initials': 'HN', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: xskzhu@fmmu.edu.cn.""}, {'ForeName': 'Long-Biao', 'Initials': 'LB', 'LastName': 'Cui', 'Affiliation': ""Department of Clinical Psychology, School of Medical Psychology, Fourth Military Medical University, 169 # West Changle Road, Xi'an, 710032, China. Electronic address: lbcui@fmmu.edu.cn.""}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.101992']
316,32145678,"Randomized control trial of evaluation of Clemastine effects on visual evoked potential, nerve fiber layer and ganglion cell layer complex in patients with optic neuritis.","OBJECTIVES


Optic neuritis (ON) is the most common cause of optic neuropathy; typically presenting with a unilateral visual loss in young adults, with incidence of 1-5 in 100,000 per year. We evaluated the effect of Clemastine, a first-generation and CNS (central nervous system)-penetrant H1 receptor antagonist on visual evoked potential (VEP), retinal nerve fibre layer (RNFL) and ganglion cell layer (GCL) complex in patients with optic neuritis.
PATIENTS AND METHODS


This is a prospective comparative interventional case series in 25 patients with acute optic neuritis. Patients were randomly assigned to group 1 (treated with Clemastine 1 mg orally twice a day for 90 days; 16 patients) or group 2 (received placebo for 90 days; 9 patients) and both groups received standard treatment of optic neuritis. We recorded VEP and peripapillary OCT (optical coherence tomography) of patients before and after three months of treatment.
RESULTS


In contrast to patients treated with Clemastine, RNFL thickness loss between base line phase and after three months follow up in control group were statistically significant in temporal, supra temporal, Infrotemporal and almost global sections of RNFL map. The reduction in GCL thickness between base line phase and after three months follow up in control group were significant, while it did not reach significance in treatment group except in inferior region.
CONCLUSION


In contrast to treatment group, RNFL and GCL thickness of most quadrants are decreased significantly after three months in patients with ON in control group. In contrast to control group, p100 wave's amplitude recovered in a significant manner in treatment group.",2020,"In contrast to treatment group, RNFL and GCL thickness of most quadrants are decreased significantly after three months in patients with ON in control group.","['patients with optic neuritis', '25 patients with acute optic neuritis']","['Clemastine', 'Clemastine, a first-generation and CNS (central nervous system)-penetrant H1 receptor antagonist', 'placebo']","['GCL thickness', 'RNFL thickness loss', 'VEP and peripapillary OCT (optical coherence tomography', 'RNFL and GCL thickness', 'visual evoked potential, nerve fiber layer and ganglion cell layer complex', 'visual evoked potential (VEP), retinal nerve fibre layer (RNFL) and ganglion cell layer (GCL) complex']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029134', 'cui_str': 'Optic Neuritis'}]","[{'cui': 'C0008929', 'cui_str': 'Clemastine'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0034814', 'cui_str': 'Receptors, H1'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0442163', 'cui_str': 'Peripapillary (qualifier value)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0546834', 'cui_str': 'Visual evoked potential study'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0228071', 'cui_str': 'Ganglion cell (cell)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}]",25.0,0.0182228,"In contrast to treatment group, RNFL and GCL thickness of most quadrants are decreased significantly after three months in patients with ON in control group.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Moghaddasi', 'Affiliation': 'Department of Neurology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Nabovvati', 'Affiliation': 'Department of Neurology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran. Electronic address: m.nabovvati@gmail.com.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Koushki', 'Affiliation': 'Department of Ophthalmology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Soltansanjari', 'Affiliation': 'Department of Ophthalmology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Sardarinia', 'Affiliation': 'Department of Ophthalmology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nafise', 'Initials': 'N', 'LastName': 'Mohebi', 'Affiliation': 'Department of Neurology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyedhossein', 'Initials': 'S', 'LastName': 'Rabani', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105741']
317,32172171,PSA and VIM DBS efficiency in essential tremor depends on distance to the dentatorubrothalamic tract.,"OBJECTIVE


To investigate the relation between deep brain stimulation (DBS) of the posterior-subthalamic-area (PSA) and the ventral-intermediate-nucleus (VIM) and the distance to the dentatorubrothalamic tract (DRTT) in essential tremor (ET).
METHODS


Tremor rating scale (TRS) hemi-scores were analyzed in 13 ET patients, stimulated in both the VIM and the PSA in a randomized, crossover trial. Distances of PSA and VIM contacts to population-based DRTTs were calculated. The relationships between distance to DRTT and stimulation amplitude, as well as DBS efficiency (TRS improvement per amplitude) were investigated.
RESULTS


PSA contacts were closer to the DRTT (p = 0.019) and led to a greater improvement in TRS hemi-scores (p = 0.005) than VIM contacts. Proximity to the DRTT was related to lower amplitudes (p < 0.001) and higher DBS efficiency (p = 0.017).
CONCLUSIONS


Differences in tremor outcome and stimulation parameters between contacts in the PSA and the VIM can be explained by their different distance to the DRTT.",2020,"RESULTS


PSA contacts were closer to the DRTT (p = 0.019) and led to a greater improvement in TRS hemi-scores (p = 0.005) than VIM contacts.",[],"['deep brain stimulation (DBS) of the posterior-subthalamic-area (PSA) and the ventral-intermediate-nucleus (VIM', 'VIM']","['PSA and VIM DBS efficiency', 'DBS efficiency', 'TRS hemi-scores', 'DBS efficiency (TRS improvement per amplitude', 'Tremor rating scale (TRS) hemi-scores']",[],"[{'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0222045'}]",13.0,0.0220309,"RESULTS


PSA contacts were closer to the DRTT (p = 0.019) and led to a greater improvement in TRS hemi-scores (p = 0.005) than VIM contacts.","[{'ForeName': 'Till A', 'Initials': 'TA', 'LastName': 'Dembek', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany. Electronic address: till.dembek@uk-koeln.de.'}, {'ForeName': 'Jan Niklas', 'Initials': 'JN', 'LastName': 'Petry-Schmelzer', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Reker', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wirths', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Stereotactic and Functional Neurosurgery, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': 'University of Cologne, Institute of Medical Statistics and Computational Biology, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Steffen', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Haidar S', 'Initials': 'HS', 'LastName': 'Dafsari', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Mauritius', 'Initials': 'M', 'LastName': 'Hövels', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Stereotactic and Functional Neurosurgery, Germany.'}, {'ForeName': 'Gereon R', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany; Cognitive Neuroscience, Institute of Neuroscience and Medicine (INM-3), Research Center Jülich, Jülich, Germany.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Visser-Vandewalle', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Stereotactic and Functional Neurosurgery, Germany.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Barbe', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102235']
318,32179059,Oxytocin increases the social salience of the outgroup in potential threat contexts.,"A growing body of literature suggests that OT administration may affect not only prosocial outcomes, but also regulate adversarial responses in the context of intergroup relations. However, recent reports have challenged the view of a fixed role of OT in enhancing ingroup favoritism and outgroup derogation. Studying the potential effects of OT in modulating threat perception in a context characterized by racial miscegenation (Brazil) may thus afford additional clarification on the matter. In a double-blind, placebo-controlled study, White Brazilian participants completed a first-person shooter task to assess their responses towards potential threat from racial ingroup (White) or outgroup (Black) members. OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets). In summary, our results indicate that a single dose of OT may promote accurate behavioral responses to potential threat from members of a racial outgroup, thus offering support to the social salience hypothesis.",2020,"OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets).",['White Brazilian participants completed a firstperson shooter task to assess their responses towards potential threat from racial ingroup (White) or outgroup (Black) members'],"['OT', 'Oxytocin', 'placebo']",['social salience'],"[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3875150', 'cui_str': 'Towards'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.040038,"OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets).","[{'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Egito', 'Affiliation': 'Social and Cognitive Neuroscience Laboratory and Developmental Disorders Graduate Program, Center for Biological and Health Sciences, Mackenzie Presbyterian University, São Paulo, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nevat', 'Affiliation': 'The Integrated Brain and Behavior Research Center (IBBR) and Department of Psychology, University of Haifa, Haifa, 3498838, Israel.'}, {'ForeName': 'Simone G', 'Initials': 'SG', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'The Integrated Brain and Behavior Research Center (IBBR) and Department of Psychology, University of Haifa, Haifa, 3498838, Israel.'}, {'ForeName': 'Ana Alexandra C', 'Initials': 'AAC', 'LastName': 'Osório', 'Affiliation': 'Social and Cognitive Neuroscience Laboratory and Developmental Disorders Graduate Program, Center for Biological and Health Sciences, Mackenzie Presbyterian University, São Paulo, Brazil. Electronic address: ana.osorio@mackenzie.br.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104733']
319,32249950,"Efficacy of electrical stimulation of denervated muscle: A multicenter, double-blind, randomized clinical trial.","BACKGROUND


This was a multicenter, double-blind, randomized clinical trial to investigate the efficacy of electrical stimulation of denervated muscle (ESDM) on recovery of patients with peripheral nerve injuries.
METHODS


We enrolled 38 patients with traumatic peripheral nerve injuries with axonal damage and clinical impairment of two muscles, who were randomly treated with real or sham electrical stimulation (ES). Clinical and neurophysiological examinations were performed before treatment, at the end of treatment, and 3 mo posttreatment, by the same physician who was blinded to the ES allocation.
RESULTS


All patients improved but there was no significant beneficial effect of ESDM compared with sham treatment.
CONCLUSIONS


This study failed to demonstrate the efficacy of ESDM for peripheral nerve injuries. However, given the large number of variables related to ES and the heterogeneity in disease etiologies and clinical manifestations, future studies on homogeneous populations using different stimulation protocols may be useful.",2020,"All patients improved but there was no significant beneficial effect of ESDM compared to sham treatment.
","['denervated muscle', 'patients with peripheral nerve injuries', '38 patients with traumatic peripheral nerve injuries with axonal damage and clinical impairment of two muscles, who were randomly treated with']","['ESDM', 'electrical stimulation', 'electrical stimulation of denervated muscle (ESDM', 'real or sham electrical stimulation (ES']",[],"[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262593', 'cui_str': 'Injury of peripheral nerve'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]",[],38.0,0.408084,"All patients improved but there was no significant beneficial effect of ESDM compared to sham treatment.
","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Piccinini', 'Affiliation': 'Fondazione Policlinico Universitario A, Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cuccagna', 'Affiliation': 'Fondazione Policlinico Universitario A, Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Caliandro', 'Affiliation': 'Fondazione Policlinico Universitario A, Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Coraci', 'Affiliation': 'Fondazione Policlinico Universitario A, Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Germanotta', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Pecchioli', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milan, Taly.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Padua', 'Affiliation': 'Fondazione Policlinico Universitario A, Gemelli IRCCS, Rome, Italy.'}]",Muscle & nerve,['10.1002/mus.26880']
320,31715140,Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial.,"OBJECTIVE


To compare participation and subjective experience of participants in both home-based multiuser virtual reality (VR) therapy and home-based single-user (SU) VR therapy.
DESIGN


Crossover, randomized trial.
SETTING


Initial training and evaluations occurred in a rehabilitation hospital; the interventions took place in participants' homes.
PARTICIPANTS


Survivors of stroke with chronic upper extremity impairment (N=20).
INTERVENTIONS


Four weeks of in-home treatment using a custom, multiuser virtual reality system (VERGE): 2 weeks of both multiuser (MU) and SU versions of VERGE. The order of presentation of SU and MU versions was randomized such that participants were divided into 2 groups, First MU and First SU.
MAIN OUTCOME MEASURES


We measured arm displacement during each session (m) as the primary outcome measure. Secondary outcome measures include time participants spent using each MU and SU VERGE and Intrinsic Motivation Inventory scores. Fugl-Meyer Assessment of Motor Recovery After Stroke Upper Extremity (FMA-UE) score and compliance with prescribed training were also evaluated. Measures were recorded before, midway, and after the treatment. Activity and movement were measured during each training session.
RESULTS


Arm displacement during a session was significantly affected the mode of therapy (MU: 414.6m, SU: 327.0m, P=.019). Compliance was very high (99% compliance for MU mode and 89% for SU mode). Within a given session, participants spent significantly more time training in the MU mode than in the SU mode (P=.04). FMA-UE score improved significantly across all participants (Δ3.2, P=.001).
CONCLUSIONS


Multiuser VR exercises may provide an effective means of extending clinical therapy into the home.",2020,"FMUE score improved significantly across all participants (Δ3.2, p=0.001).
","[""participants' homes PARTICIPANTS: Stroke survivors with chronic upper extremity impairment ""]","['home-based multi-user VR therapy and home-based single-user VR therapy', '4 weeks of in-home treatment using a custom, multi-user virtual reality system (VERGE): two weeks of both multi-user (MU) and single-user (SU) versions of VERGE', 'Home-based upper extremity stroke therapy using a multi-user virtual reality environment']","['Fugl-Meyer Upper-Extremity (FMUE) score and compliance with prescribed training', 'FMUE score', 'time training', ' time participants spent using each MU and SU VERGE, and Intrinsic Motivation Inventory (IMI) scores', 'Activity and movement']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation, function (observable entity)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",,0.0332563,"FMUE score improved significantly across all participants (Δ3.2, p=0.001).
","[{'ForeName': 'Kelly O', 'Initials': 'KO', 'LastName': 'Thielbar', 'Affiliation': 'Shirley Ryan AbilityLab, Chicago, Illinois. Electronic address: kellythielbar@gmail.com.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Triandafilou', 'Affiliation': 'Shirley Ryan AbilityLab, Chicago, Illinois.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Barry', 'Affiliation': 'Shirley Ryan AbilityLab, Chicago, Illinois.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Yuan', 'Affiliation': 'Shirley Ryan AbilityLab, Chicago, Illinois.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Nishimoto', 'Affiliation': 'Electronic Visualization Laboratory, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'Shirley Ryan AbilityLab, Chicago, Illinois.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Stoykov', 'Affiliation': 'Shirley Ryan AbilityLab, Chicago, Illinois.'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Tsoupikova', 'Affiliation': 'Electronic Visualization Laboratory, University of Illinois at Chicago, Chicago, Illinois; School of Design, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Derek G', 'Initials': 'DG', 'LastName': 'Kamper', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, Illinois; UNC/NC State Joint Department of Biomedical Engineering, North Carolina State University, Raleigh, North Carolina; Closed-Loop Engineering for Advanced Rehabilitation Research Core, North Carolina State University, Raleigh, North Carolina.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.10.182']
321,31925473,"Effects of a resistance and balance exercise programme on physical fitness, health-related quality of life and fear of falling in older women with osteoporosis and vertebral fracture: a randomized controlled trial.","Exercise is recommended for people with osteoporosis, but the effect for people who have suffered vertebral fracture is uncertain. This study shows that a multicomponent exercise-program based on recommendations for people with osteoporosis improved muscle strength, balance, and fear of falling in older women with osteoporosis and vertebral fracture.
INTRODUCTION


Guidelines for exercise strongly recommend that older adults with osteoporosis or osteoporotic vertebral fracture should engage in a multicomponent exercise programme that includes resistance training in combination with balance training. Prior research is scarce and shows inconsistent findings. This study examines whether current exercise guidelines for osteoporosis, when applied to individuals with vertebral fractures, can improve health outcomes.
METHODS


This single blinded randomized controlled trial included 149 older women diagnosed with osteoporosis and vertebral fracture, 65+ years. The intervention group performed a 12-week multicomponent exercise programme, the control group received usual care. Primary outcome was habitual walking speed, secondary outcomes were physical fitness (Senior Fitness Test, Functional Reach and Four Square Step Test), health-related quality of life and fear of falling. Descriptive data was reported as mean (standard deviation) and count (percent). Data were analyzed following intention to treat principle and per protocol. Between-group differences were assessed using linear regression models (ANCOVA analysis).
RESULTS


No statistically significant difference between the groups were found on the primary outcome, walking speed (mean difference 0.04 m/s, 95% CI - 0.01-0.09, p = 0.132). Statistically significant between-group differences in favour of intervention were found on FSST (dynamic balance) (mean difference - 0.80 s, 95% CI - 1.57 to - 0.02, p = 0.044), arm curl (mean difference 1.55, 95% CI 0.49-2.61, p = 0.005) and 30-s STS (mean difference 1.85, 95% CI 1.04-2.67, p < 0.001), as well as fear of falling (mean difference - 1.45, 95% CI - 2.64 to - 0.26, p = 0.018). No statistically significant differences between the groups were found on health-related quality of life.
CONCLUSION


Twelve weeks of a supervised multicomponent resistance and balance exercise programme improves muscle strength and balance and reduces fear of falling, in women with osteoporosis and a history of vertebral fractures.
TRIAL REGISTRATION


ClincialTrials.gov Identifier: NCT02781974. Registered 25.05.16. Retrospectively registered.",2020,"Twelve weeks of a supervised multicomponent resistance and balance exercise programme improves muscle strength and balance and reduces fear of falling, in women with osteoporosis and a history of vertebral fractures.
","['older adults with osteoporosis or osteoporotic vertebral fracture', 'individuals with vertebral fractures', 'women with osteoporosis and a history of vertebral fractures', '149 older women diagnosed with osteoporosis and vertebral fracture, 65+\u2009years', 'people with osteoporosis', 'older women with osteoporosis and vertebral fracture']","['current exercise guidelines', 'multicomponent exercise-program', 'supervised multicomponent resistance and balance exercise programme', 'multicomponent exercise programme, the control group received usual care', 'resistance and balance exercise programme', 'multicomponent exercise programme']","['muscle strength, balance, and fear of falling', 'muscle strength and balance and reduces fear of falling', 'FSST (dynamic balance', 'habitual walking speed, secondary outcomes were physical fitness (Senior Fitness Test, Functional Reach and Four Square Step Test), health-related quality of life and fear of falling', 'fear of falling', 'health-related quality of life', 'walking speed', 'physical fitness, health-related quality of life and fear of falling']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1272070', 'cui_str': 'H/O: vertebral fracture'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}]",149.0,0.100939,"Twelve weeks of a supervised multicomponent resistance and balance exercise programme improves muscle strength and balance and reduces fear of falling, in women with osteoporosis and a history of vertebral fractures.
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Stanghelle', 'Affiliation': 'Institute of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, PO Box 4, St. Olavs plass, 0130, Oslo, Norway. bsugland@oslomet.no.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bentzen', 'Affiliation': 'Leader of the Institute of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, PO Box 4, St. Olavs Plass, 0130, Oslo, Norway.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Giangregorio', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Schlegel-UW Research Institute for Aging, Canada.250 Laurelwood Dr, Waterloo, ON, N2J 0E2, Canada.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Pripp', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, PO Box 4, St. Olavs Plass, 0130, Oslo, Norway.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Skelton', 'Affiliation': 'School of Health and Life Sciences, Centre for Living, Glasgow Caledonian University, Cowcaddens Rd, Glasgow, G4 0BA, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bergland', 'Affiliation': 'Institute of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, PO Box 4, St. Olavs Plass, 0130, Oslo, Norway.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-05256-4']
322,32331460,"The Effects of Biofeedback Training and Smartphone-Delivered Biofeedback Training on Resilience, Occupational Stress, and Depressive Symptoms among Abused Psychiatric Nurses.","Psychiatric ward (PW) nurses are at a higher risk to encounter workplace violence than are other healthcare providers, and many interventions have been developed to improve their mental health. We compared the effectiveness of biofeedback training (BT) and smartphone-delivered BT (SDBT) interventions on occupational stress, depressive symptoms, resilience, heart rate variability, and respiration rate in a sample of abused PW nurses. This was a quasi-experimental study. Structured questionnaires were administered before and six weeks after the intervention. Data were collected from April 2017 to October 2017. A total of 159 abused PW nurses were randomly assigned to BT, SDBT, and control groups, and 135 of them completed all processes of our protocol, with the study consisting of 119 females (88.1%) and 16 males (11.9%) and their age range being from 22 to 59 with the mean age of 35.61 and a standard deviation of 8.16. Compared to the controls, both the BT and the SDBT intervention groups experienced significant improvements in depressive symptoms, resilience, and respiration rate; and the SDBT group experienced significant reductions in occupational stress. Considering the cost, accessibility, restrictions time and space, SDBT be used as an effective intervention in people with resilience or occupational stress.",2020,"Compared to the controls, both the BT and the SDBT intervention groups experienced significant improvements in depressive symptoms, resilience, and respiration rate; and the SDBT group experienced significant reductions in occupational stress.","['people with resilience or occupational stress', 'Abused Psychiatric Nurses', ' and control groups, and 135 of them completed all processes of our protocol, with the study consisting of 119 females (88.1%) and 16 males (11.9%) and their age range being from 22 to 59 with the mean age of 35.61 and a standard deviation of 8.16', '159 abused PW nurses']","['biofeedback training (BT) and smartphone-delivered BT (SDBT) interventions', 'SDBT intervention', 'Biofeedback Training and Smartphone-Delivered Biofeedback Training', 'BT, SDBT']","['occupational stress, depressive symptoms, resilience, heart rate variability, and respiration rate', 'Resilience, Occupational Stress, and Depressive Symptoms', 'depressive symptoms, resilience, and respiration rate', 'occupational stress']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",,0.0281066,"Compared to the controls, both the BT and the SDBT intervention groups experienced significant improvements in depressive symptoms, resilience, and respiration rate; and the SDBT group experienced significant reductions in occupational stress.","[{'ForeName': 'Hsiu-Fen', 'Initials': 'HF', 'LastName': 'Hsieh', 'Affiliation': 'School of Nursing, College of Nursing, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung 807, Taiwan.'}, {'ForeName': 'I-Chin', 'Initials': 'IC', 'LastName': 'Huang', 'Affiliation': 'School of Nursing, College of Nursing, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, College of Nursing, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Wen-Ling', 'Initials': 'WL', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Tsyr-Huey Mental Hospital, Kaohsiung 831, Taiwan.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Lee', 'Affiliation': 'Nursing Department, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Hsin-Tien', 'Initials': 'HT', 'LastName': 'Hsu', 'Affiliation': 'School of Nursing, College of Nursing, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung 807, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17082905']
323,32062021,"The effect of Instagram #fitspiration images on young women's mood, body image, and exercise behaviour.","The present study experimentally examined the effects of viewing Instagram images of fitspiration on body dissatisfaction, mood, and exercise behaviour among young women. Further, the study investigated if exercise engagement following exposure to fitspiration images could mitigate any negative effects from image exposure. Participants were 108 women, aged 17-25 years, who were randomly assigned to a 2 (image type: fitspiration, travel inspiration) × 2 (activity type: exercise, quiet rest) between groups design. State body dissatisfaction and mood were assessed at baseline, following image exposure, and following participation in 10 min of walking or quiet rest. Results demonstrated that exposure to fitspiration images led to significantly higher negative mood and body dissatisfaction relative to exposure to travel images. There was no difference in actual exercise behaviour according to image type. However, participants who exercised following exposure to fitspiration images were significantly more likely to report higher subjective exertion ratings. Overall, negative mood and body dissatisfaction decreased after both exercise and quiet rest, with no additional benefit of exercise for the fitspiration condition. These findings provide further evidence highlighting fitspiration as a potentially harmful online trend.",2020,"Overall, negative mood and body dissatisfaction decreased after both exercise and quiet rest, with no additional benefit of exercise for the fitspiration condition.","[""young women's mood, body image, and exercise behaviour"", 'Participants were 108 women, aged 17-25 years', 'young women']","['2 (image type: fitspiration, travel inspiration']","['actual exercise behaviour', 'body dissatisfaction, mood, and exercise behaviour', 'Overall, negative mood and body dissatisfaction', 'subjective exertion ratings']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0429689', 'cui_str': 'Exertion rating (staging scale)'}]",108.0,0.0528909,"Overall, negative mood and body dissatisfaction decreased after both exercise and quiet rest, with no additional benefit of exercise for the fitspiration condition.","[{'ForeName': 'Ivanka', 'Initials': 'I', 'LastName': 'Prichard', 'Affiliation': 'Health & Exercise Sciences, College of Nursing & Health Sciences, Flinders University, Adelaide, South Australia, Australia; SHAPE Research Centre, Flinders University, Adelaide, South Australia, Australia. Electronic address: ivanka.prichard@flinders.edu.au.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Kavanagh', 'Affiliation': 'Psychology, College of Education, Psychology & Social Work, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Maroochydore, Australia.'}, {'ForeName': 'Megan S C', 'Initials': 'MSC', 'LastName': 'Lim', 'Affiliation': 'Burnet Institute, 85 Commercial Rd, Melbourne, Australia; School of Population Health and Preventive Medicine, Monash University, Melbourne, Australia; Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'Psychology, College of Education, Psychology & Social Work, Flinders University, Adelaide, South Australia, Australia.'}]",Body image,['10.1016/j.bodyim.2020.02.002']
324,32146231,The efficacy and safety of multiple-dose intravenous tranexamic acid in reducing perioperative blood loss in patients with thoracolumbar burst fracture.,"OBJECTIVE


To evaluate the efficacy and safety of tranexamic acid (TXA) for single-segment thoracolumbar burst fracture without neurologic injury underwent pedicle screw fixation via Wiltse approach.
PATIENTS AND METHODS


We identified 264 patients with single-segment thoracolumbar burst fracture without neurologic injury underwent pedicle screw fixation via Wiltse approach (January 2016-June 2019) at a single center. The cohort was separated into three groups. Group A received 20 mg/kg TXA at 5 min before skin incision and 16 h after first dose; Group B received 20 mg/kg TXA at 5 min before skin incision; Group C received NS at each same time point. The outcomes were evaluated by hidden blood loss (HBL), total blood loss (TBL), intraoperative blood loss (IBL), transfusion rate, maximum hemoglobin (Hb) drop, prethrombotic state molecular markers, liver and renal function, coagulation function, inflammatory factor and adverse events.
RESULTS


The HBL, TBL and maximum Hb drop were significantly lower in Group A than those of Group B and Group C, while the difference between Group B and Group C was statistically significant. The IBL was significantly lower in Group A and Group B than that of Group C. However, there was no significantly difference among the three groups in live and renal function, coagulation function, prethrombotic state molecular markers, transfusion rate and complications during the perioperative period. There was significantly lower level of interleukin-6 (IL-6) in Group A than Group C at the day after surgery, and lower level of C-reactive protein (CRP) at the third day after surgery.
CONCLUSIONS


Intravenous TXA used in the treatment of thoracolumbar burst fracture underwent pedicle screw fixation via Wiltse approach is effective and safe in decreasing perioperative blood loss. The two-dose TXA regimen can further reduce blood loss and alleviate post-operative inflammation response, without affecting prethrombotic state molecular marks and without increasing the risk of complications.",2020,"There was significantly lower level of interleukin-6 (IL-6) in Group A than Group C at the day after surgery, and lower level of C-reactive protein (CRP) at the third day after surgery.
","['patients with thoracolumbar burst fracture', '264 patients with single-segment thoracolumbar burst fracture without neurologic injury underwent']","['tranexamic acid', 'pedicle screw fixation', 'pedicle screw fixation via Wiltse approach', '20 mg/kg TXA', 'TXA', 'tranexamic acid (TXA']","['hidden blood loss (HBL), total blood loss (TBL), intraoperative blood loss (IBL), transfusion rate, maximum hemoglobin (Hb) drop, prethrombotic state molecular markers, liver and renal function, coagulation function, inflammatory factor and adverse events', 'level of interleukin-6 (IL-6', 'blood loss and alleviate post-operative inflammation response', 'HBL, TBL and maximum Hb drop', 'live and renal function, coagulation function, prethrombotic state molecular markers, transfusion rate and complications', 'perioperative blood loss', 'level of C-reactive protein (CRP', 'IBL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0859903', 'cui_str': 'Burst fracture'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C1719994', 'cui_str': 'Animal hide'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.0345035,"There was significantly lower level of interleukin-6 (IL-6) in Group A than Group C at the day after surgery, and lower level of C-reactive protein (CRP) at the third day after surgery.
","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics, Dalian Medical University, Dalian, 116000, China; Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Nan', 'Affiliation': ""Department of Orthopedics, Dalian Medical University, Dalian, 116000, China; Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Xinmin', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Yongxiang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Jiandong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Orthopaedic Implants, Shanghai, 200011, China.""}, {'ForeName': 'Shengfei', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China. Electronic address: zhangliang6320@sina.com.""}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105766']
325,32330433,Effect of prednisolone on language function in children with autistic spectrum disorder: a randomized clinical trial.,"OBJECTIVE


To describe the effect of prednisolone on language in children with autism spectrum disorder. This study is based upon two hypotheses: autism etiology may be closely related to neuroinflammation; and, an effective treatment should restore the individual's language skills.
METHOD


This is a prospective, double-blinded, randomized, placebo-controlled clinical trial, carried out in a federal university hospital. The initial patient sample consisted of 40 subjects, which were randomized into two parallel groups. Inclusion criteria were: male gender, 3-7 years of age, and meeting the Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) diagnostic criteria. The final sample consisted of 38 patients, of whom 20 were randomized to the placebo group and 18 to the active group. The latter received prednisolone for 24 weeks, at an initial dose of 1mg/kg/day and a tapering dose from the ninth week onward. Language was measured on four occasions over a 12-month period by applying two Brazilian tools: the Language Development Assessment (ADL) and the Child Language Test in Phonology, Vocabulary, Fluency, and Pragmatics (ABFW).
RESULTS


The side effects were mild: two patients had hypertension, five had hyperglycemia, and two had varicella. Prednisolone increased the global ADL score in children younger than 5 years of age who had developmental regression (p=0.0057). The ABFW's total of communicative acts also responded favorably in those participants with regression (p=0.054). The ABFW's total of vocal acts showed the most significant results, especially in children younger than 5 years (p=0.004, power=0.913).
CONCLUSIONS


The benefit of prednisolone for language scores was more evident in participants who were younger than five years, with a history of developmental regression, but the trial's low dose may have limited this benefit. The observed side effects do not contraindicate corticosteroid use in autism.",2020,Prednisolone increased the global ADL score in children younger than 5 years of age who had developmental regression (p=0.0057).,"['federal university hospital', 'children with autism spectrum disorder', 'children younger than 5 years of age who had developmental regression (p=0.0057', 'Inclusion criteria were: male gender, 3-7 years of age, and meeting the Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) diagnostic criteria', 'children with autistic spectrum disorder', 'participants who were younger than five years', 'initial patient sample consisted of 40 subjects']","['placebo', 'Prednisolone', 'prednisolone']","['Language Development Assessment (ADL) and the Child Language Test in Phonology, Vocabulary, Fluency, and Pragmatics (ABFW', ""ABFW's total of communicative acts"", 'global ADL score', 'language function', 'language scores']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1836830', 'cui_str': 'Developmental regression'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0023013', 'cui_str': 'Language Development'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008081', 'cui_str': 'Child Language'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",40.0,0.32767,Prednisolone increased the global ADL score in children younger than 5 years of age who had developmental regression (p=0.0057).,"[{'ForeName': 'Adriana Rocha', 'Initials': 'AR', 'LastName': 'Brito', 'Affiliation': 'Universidade Federal Fluminense (UFF), Departamento Materno-Infantil, Niterói, RJ, Brazil.'}, {'ForeName': 'Giselle de Paula Teixeira', 'Initials': 'GPT', 'LastName': 'Vairo', 'Affiliation': 'Universidade Federal Fluminense (UFF), Departamento Materno-Infantil, Niterói, RJ, Brazil.'}, {'ForeName': 'Ana Paula Botelho Henriques', 'Initials': 'APBH', 'LastName': 'Dias', 'Affiliation': 'Universidade Federal Fluminense (UFF), Departamento Materno-Infantil, Niterói, RJ, Brazil.'}, {'ForeName': 'Beni', 'Initials': 'B', 'LastName': 'Olej', 'Affiliation': 'Universidade Federal Fluminense (UFF), Departamento de Medicina Clínica, Niterói, RJ, Brazil.'}, {'ForeName': 'Osvaldo José Moreira', 'Initials': 'OJM', 'LastName': 'Nascimento', 'Affiliation': 'Universidade Federal Fluminense (UFF), Departamento de Medicina Clínica, Niterói, RJ, Brazil.'}, {'ForeName': 'Marcio Moacyr', 'Initials': 'MM', 'LastName': 'Vasconcelos', 'Affiliation': 'Universidade Federal Fluminense (UFF), Departamento Materno-Infantil, Niterói, RJ, Brazil. Electronic address: mmdvascon@gmail.com.'}]",Jornal de pediatria,['10.1016/j.jped.2019.10.012']
326,31469982,Poststroke Postural Sway Improved by Botulinum Toxin: A Multicenter Randomized Double-blind Controlled Trial.,"OBJECTIVE


To assess the effects of injecting botulinum toxin into the lower limb muscles of people with hemiparesis post stroke in terms of their sway areas.
DESIGN


A multicenter randomized double-blind trial on the effects of active botulinum toxin treatment vs placebo.
SETTING


Clinical examinations and postural sway assessments were performed before botulinum toxin injection and again 4-6 weeks after the injection.
PARTICIPANTS


People with hemiparesis with chronic post stroke lower limb spasticity (N=40).
INTERVENTIONS


Intramuscular injection of a placebo (physiological serum) was performed on the control group, and botulinum toxin injections were performed on the treatment group. Participants and physical and rehabilitation medicine specialists were given no information as to which of the 2 treatments was applied.
MAIN OUTCOME MEASURES


The sway area of the center of pressure was recorded for 30 seconds in 3 conditions: eyes open, eyes open in a dual task (a postural control task combined with an arithmetic task), and eyes closed. Spasticity was measured using the Modified Ashworth Scale.
RESULTS


Forty people post stroke were enrolled and randomized into 2 groups, one of which was treated with botulinum toxin (n=19) and the other with placebo (n=21). Spasticity decreased significantly in the treatment group (-0.7, P=.049 in the soleus muscles; -0.8, P=.035 in the gastrocnemii muscles). The sway area did not differ significantly between the 2 groups before treatment. The most conspicuous effect was observed in the case of the dual task, where a significant decrease (P=.005) in the sway area occurred in the treatment group (-3.11±6.92) in comparison with the placebo group (+0.27±3.57).
CONCLUSION


Treating spasticity by injecting botulinum toxin into people's lower limb muscles post stroke seems to improve their postural sway. The dual task used here to assess sway seems to be a useful, sensitive test for this purpose.",2020,Spasticity decreased significantly in the treatment group (-0.7;,"['hemiparetic people post-stroke in terms of their sway areas', 'Forty post-stroke', 'Forty chronic hemiparetic people post-stroke with lower limb spasticity']","['eyes open in a dual task (a postural control task combined with an arithmetic task), and eyes closed', 'botulinum toxin injections', 'placebo', 'botulinum toxin', 'placebo (physiological serum', 'botulinum toxin injection', 'active botulinum toxin']","['sway area of the center of pressure', 'Spasticity', 'sway area']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}]","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}]",40.0,0.189181,Spasticity decreased significantly in the treatment group (-0.7;,"[{'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Kerzoncuf', 'Affiliation': 'Aix Marseille University, APHM, INT, Inst Neurosci Timone, CHU Timone, Physical and Rehabilitation Medicine Department, Marseille, France. Electronic address: marjorie.kerzoncuf@ap-hm.fr.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Viton', 'Affiliation': 'Aix Marseille University, APHM, INT, Inst Neurosci Timone, CHU Timone, Physical and Rehabilitation Medicine Department, Marseille, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Pellas', 'Affiliation': 'Physical and Rehabilitation Medicine Department, University Hospital of Nîmes, Nîmes, France.'}, {'ForeName': 'Maeva', 'Initials': 'M', 'LastName': 'Cotinat', 'Affiliation': 'Aix Marseille University, APHM, INT, Inst Neurosci Timone, CHU Timone, Physical and Rehabilitation Medicine Department, Marseille, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Calmels', 'Affiliation': 'Physical and Rehabilitation Medicine Department, University Hospital of Saint Etienne, Saint Etienne, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Milhe de Bovis', 'Affiliation': 'Aix Marseille University, APHM, INT, Inst Neurosci Timone, CHU Timone, Physical and Rehabilitation Medicine Department, Marseille, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Delarque', 'Affiliation': 'Aix Marseille University, APHM, INT, Inst Neurosci Timone, CHU Timone, Physical and Rehabilitation Medicine Department, Marseille, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bensoussan', 'Affiliation': 'Aix Marseille University, APHM, INT, Inst Neurosci Timone, CHU Timone, Physical and Rehabilitation Medicine Department, Marseille, France.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.04.024']
327,31937532,The Effect of Warfarin Administration Time on Anticoagulation Stability (INRange): A Pragmatic Randomized Controlled Trial.,"PURPOSE


Without supporting evidence, clinicians commonly recommend that warfarin be taken in the evening. We conducted a randomized controlled trial to evaluate the effect of administration time (morning vs evening) on the stability of warfarin's anticoagulant effect.
METHODS


A total of 236 primary care physicians serving 54 western Canadian communities mailed letters of invitation to all their warfarin-using patients. Eligible patients were community-dwelling warfarin users (any indication) with at least 3 months of evening warfarin use and no plans for discontinuation. Participants were randomized (by web-based allocation) to morning vs continued evening warfarin ingestion. We used the Rosendaal method to determine the proportion of time within therapeutic range (TTR) of the international normalized ratio (INR) blood test month 2 to 7 postrandomization vs the 6 months prerandomization. The primary outcome was the percent change in proportion of time outside target INR range (with an a priori minimum clinically important difference of ±20%). All analyses were intention to treat.
RESULTS


Between March 8, 2015 and September 30, 2016, we randomized 109 participants to morning and 108 to evening warfarin use. TTR rose from 71.8% to 74.7% in the morning group, and from 72.6% to 75.6% in the evening group, for a change in TTR of 2.9% in the former vs 3.0% in the latter (difference, -0.1%;  P  = .97; 95% CI for the difference, -6.1% to 5.9%). The difference in percent change in proportion of time outside the therapeutic INR range (obtained via Hodges-Lehmann estimation of the difference in medians) was 4.4% ( P  = .62; 95% CI for the difference, -17.6% to 27.3%).
CONCLUSIONS


Administration time has no statistically significant nor clinically important impact on the stability of warfarin's anticoagulant effect. Patients should take warfarin whenever regular compliance would be easiest.",2020,"TTR rose from 71.8% to 74.7% in the morning group, and from 72.6% to 75.6% in the evening group, for a change in TTR of 2.9% in the former vs 3.0% in the latter (difference, -0.1%;  P  = .97; 95% CI for the difference, -6.1% to 5.9%).","['Between March 8, 2015 and September 30, 2016', 'Eligible patients were community-dwelling warfarin users (any indication) with at least 3 months of evening warfarin use and no plans for discontinuation', '236 primary care physicians serving 54 western Canadian communities mailed letters of invitation to all their warfarin-using patients', '109 participants to morning and 108 to evening warfarin use']","['warfarin', 'Warfarin']","['Anticoagulation Stability (INRange', 'proportion of time within therapeutic range (TTR) of the international normalized ratio (INR) blood test', 'proportion of time outside the therapeutic INR range', 'TTR', 'percent change in proportion of time outside target INR range']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0460097', 'cui_str': 'Within therapeutic range (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",109.0,0.270049,"TTR rose from 71.8% to 74.7% in the morning group, and from 72.6% to 75.6% in the evening group, for a change in TTR of 2.9% in the former vs 3.0% in the latter (difference, -0.1%;  P  = .97; 95% CI for the difference, -6.1% to 5.9%).","[{'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Garrison', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada scott.garrison@ualberta.ca.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Green', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Kolber', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Korownyk', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Olivier', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Balraj S', 'Initials': 'BS', 'LastName': 'Heran', 'Affiliation': 'Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Flesher', 'Affiliation': 'Fraser Health Authority, Burnaby, British Columbia, Canada.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Allan', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada.'}]",Annals of family medicine,['10.1370/afm.2488']
328,32331244,Dietary Intervention in Pregnant Women with Gestational Diabetes; Protocol for the DiGest Randomised Controlled Trial.,"Gestational diabetes mellitus (GDM) annually affects 35,000 pregnancies in the United Kingdom, causing suboptimal health outcomes to the mother and child. Obesity and excessive gestational weight gain are risk factors for GDM. The Institute of Medicine recommends weight targets for women that are overweight and obese, however, there are no clear guidelines for women with GDM. Observational data suggest that modest weight loss (0.6-2 kg) after 28 weeks may reduce risk of caesarean section, large-for-gestational-age (LGA), and maternal postnatal glycaemia. This protocol for a multicentre randomised double-blind controlled trial aims to identify if a fully controlled reduced energy diet in GDM pregnancy improves infant birthweight and reduces maternal weight gain (primary outcomes). A total of 500 women with GDM (National Institute of Health and Care Excellence (NICE) 2015 criteria) and body mass index (BMI) ≥25 kg/m 2  will be randomised to receive a standard (2000 kcal/day) or reduced energy (1200 kcal/day) diet box containing all meals and snacks from 28 weeks to delivery. Women and caregivers will be blinded to the allocations. Food diaries, continuous glucose monitoring, and anthropometry will measure dietary compliance, glucose levels, and weight changes. Women will receive standard antenatal GDM management (insulin/metformin) according to NICE guidelines. The secondary endpoints include caesarean section rates, LGA, and maternal postnatal glucose concentrations.",2020,This protocol for a multicentre randomised double-blind controlled trial aims to identify if a fully controlled reduced energy diet in GDM pregnancy improves infant birthweight and reduces maternal weight gain (primary outcomes).,"['women with GDM', 'Pregnant Women with Gestational Diabetes', '500 women with GDM (National Institute of Health and Care Excellence (NICE) 2015 criteria) and body mass index (BMI) ≥25 kg/m 2', 'Gestational diabetes mellitus (GDM) annually affects 35,000 pregnancies in the United Kingdom, causing suboptimal health outcomes to the mother and child']","['Dietary Intervention', 'standard (2000 kcal/day) or reduced energy (1200 kcal/day) diet box containing all meals and snacks from 28 weeks to delivery', 'standard antenatal GDM management (insulin/metformin']","['weight loss', 'Food diaries, continuous glucose monitoring, and anthropometry will measure dietary compliance, glucose levels, and weight changes', 'caesarean section rates, LGA, and maternal postnatal glucose concentrations', 'risk of caesarean section, large-for-gestational-age (LGA), and maternal postnatal glycaemia', 'Obesity and excessive gestational weight gain', 'maternal weight gain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",500.0,0.204451,This protocol for a multicentre randomised double-blind controlled trial aims to identify if a fully controlled reduced energy diet in GDM pregnancy improves infant birthweight and reduces maternal weight gain (primary outcomes).,"[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Kusinski', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Murphy', 'Affiliation': 'Cambridge Universities NHS Foundation Trust, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Emanuella', 'Initials': 'E', 'LastName': 'De Lucia Rolfe', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre-Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Rennie', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre-Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Oude Griep', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre-Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Institute of Cellular Medicine, University of Newcastle, Cambridge NE4 5PL, UK.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Meek', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK.'}]",Nutrients,['10.3390/nu12041165']
329,32331270,Change in the Mindset of a Paediatric Exercise Physiologist: A Review of Fifty Years Research.,"In this review, the career of a pediatric exercise physiologist (HCGK) is given over a period of almost 50 years. His research was concentrated on the relationship of physical activity (physical education, sport, and daily physical activity) with health and fitness in teenagers in secondary schools. (1) His first experiment was an exercise test on a bicycle ergometer to measure aerobic fitness by estimating physical work capacity at a heart rate of 170 beats/minute (PWC 170 ). (2) Secondly, a randomized control trial (RCT) was performed with an intervention of more intensive physical education (PE) with circuit interval training during three lessons per week over a period of six weeks. (3) Thereafter, a second RCT was performed with an intervention of two extra PE lessons per week over a whole school year. The results of these two RCTs appeared to be small or nonsignificant, probably because the effects were confounded by differences in maturation and the habitual physical activity of these teenagers. (4) Therefore, the scope of the research was changed into the direction of a long-term longitudinal study (the Amsterdam Growth And Health Longitudinal Study). This study included male and female teenagers that were followed over many years to get insight into the individual changes in biological factors (growth, fitness, obesity, hypercholesterolemia, and hypertension) and lifestyle parameters such as nutrition, smoking, alcohol usage, and daily physical activity. With the help of new advanced statistical methods (generalized estimating equations, random coefficient analysis, and autoregression analysis) suitable for longitudinal data, research questions regarding repeated measurements, tracking, or stability were answered. New measurement techniques such as mineral bone density by means of dual-energy X-ray absorptiometry (DEXA) showed that bone can also be influenced by short bursts of mechanical load. This changed his mind: In children and adolescents, not only can daily aerobic exercise of at least 30 to 60 minutes duration increase the aerobic power of muscles, but very short highly intensive bursts of less than one minute per day can also increase the strength of their bones.",2020,"His research was concentrated on the relationship of physical activity (physical education, sport, and daily physical activity) with health and fitness in teenagers in secondary schools.","['male and female teenagers', 'teenagers in secondary schools']","['intensive physical education (PE) with circuit interval training', 'pediatric exercise physiologist (HCGK']","['habitual physical activity', 'strength of their bones', 'biological factors (growth, fitness, obesity, hypercholesterolemia, and hypertension) and lifestyle parameters such as nutrition, smoking, alcohol usage, and daily physical activity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}]","[{'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0260141', 'cui_str': 'Physiologist'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0270298,"His research was concentrated on the relationship of physical activity (physical education, sport, and daily physical activity) with health and fitness in teenagers in secondary schools.","[{'ForeName': 'Han C G', 'Initials': 'HCG', 'LastName': 'Kemper', 'Affiliation': 'Emeritus Professor in Health and Physical Activity, Amsterdam UMC, Amsterdam Public Health Research Institute, 1081 BT Amsterdam, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17082888']
330,32331301,Personalized Treatment Suggestions: The Validity and Applicability of the Risk-Prevention-Index Social in Low Back Pain Exercise Treatments.,"Background:  The back pain screening tool Risk-Prevention- I ndex  S ocial (RPI-S) identifies the individual psychosocial risk for low back pain chronification and supports the allocation of patients at risk in additional multidisciplinary treatments. The study objectives were to evaluate (1) the prognostic validity of the RPI-S for a 6-month time frame and (2) the clinical benefit of the RPI-S.  Methods:  In a multicenter single-blind 3-armed randomized controlled trial,  n  = 660 persons (age 18-65 years) were randomly assigned to a twelve-week uni- or multidisciplinary exercise intervention or control group. Psychosocial risk was assessed by the RPI-S domain social environment (RPI-S SE ) and the outcome pain by the Chronic Pain Grade Questionnaire (baseline M1, 12-weeks M4, 24-weeks M5). Prognostic validity was quantified by the root mean squared error (RMSE) within the control group. The clinical benefit of RPI-S SE  was calculated by repeated measures ANOVA in intervention groups.  Results:  A subsample of  n  = 274 participants (mean = 38.0 years, SD 13.1) was analyzed, of which 30% were classified at risk in their psychosocial profile. The half-year prognostic validity was good (RMSE for disability of 9.04 at M4 and of 9.73 at M5; RMSE for pain intensity of 12.45 at M4 and of 14.49 at M5). People at risk showed significantly stronger reduction in pain disability and intensity at M4/M5, if participating in a multidisciplinary exercise treatment. Subjects at no risk showed a smaller reduction in pain disability in both interventions and no group differences for pain intensity. Regarding disability due to pain, around 41% of the sample would gain an unfitted treatment without the back pain screening.  Conclusion:  The RPI-S SE  prognostic validity demonstrated good applicability and a clinical benefit confirmed by a clear advantage of an individualized treatment possibility.",2020,"People at risk showed significantly stronger reduction in pain disability and intensity at M4/M5, if participating in a multidisciplinary exercise treatment.","['n  = 660 persons (age 18-65 years', 'A subsample of  n  = 274 participants (mean = 38.0 years, SD 13.1) was analyzed, of which 30% were classified at risk in their psychosocial profile']","['multidisciplinary exercise intervention or control group', 'Prevention', 'S ocial (RPI-S', 'Personalized Treatment Suggestions']","['pain intensity', 'RPI-S domain social environment (RPI-S SE ) and the outcome pain by the Chronic Pain Grade Questionnaire (baseline M1, 12-weeks M4, 24-weeks M5', 'pain disability and intensity', 'pain disability', 'Prognostic validity', 'Psychosocial risk']","[{'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0037414', 'cui_str': 'Social context'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",30.0,0.0381605,"People at risk showed significantly stronger reduction in pain disability and intensity at M4/M5, if participating in a multidisciplinary exercise treatment.","[{'ForeName': 'Pia-Maria', 'Initials': 'PM', 'LastName': 'Wippert', 'Affiliation': 'Sociology of Health and Physical Activity, University of Potsdam, 14469 Potsdam, Germany.'}, {'ForeName': 'Anne-Katrin', 'Initials': 'AK', 'LastName': 'Puschmann', 'Affiliation': 'Sociology of Health and Physical Activity, University of Potsdam, 14469 Potsdam, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Drießlein', 'Affiliation': 'Statistical Consulting Unit StaBLab, Ludwig-Maximilians-Universität München, 80539 Munich, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt, 60323 Frankfurt am Main, Germany.'}, {'ForeName': 'Heidrun', 'Initials': 'H', 'LastName': 'Beck', 'Affiliation': 'University Hospital Carl Gustav Carus at Technical University Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Schiltenwolf', 'Affiliation': 'Pain Management, Centre of Orthopaedics and Trauma Surgery, Heidelberg University Hospital, 69118 Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schneider', 'Affiliation': 'Orthopädiezentrum Theresie, 80339 München, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Mayer', 'Affiliation': 'University Outpatient Clinic, Centre of Sports Medicine, University of Potsdam, 14469 Potsdam, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9041197']
331,32062566,Alleviation of ADHD symptoms by non-invasive right prefrontal stimulation is correlated with EEG activity.,"Attention deficit hyperactivity disorder (ADHD) is a prevalent disorder with effective pharmacological treatment that benefits most patients. However, about one-third fail to benefit while others search non-pharmacological alternatives, and for those options are scarce. One alternative treatment option is to alter abnormal right prefrontal cortex (rPFC) activity, given that rPFC abnormality has been repeatedly implicated in ADHD neurophathology. Here, we evaluated whether targeting the rPFC with multiple sessions of repetitive transcranial magnetic stimulation (rTMS), which can modulate neuronal excitability, activity, and plasticity in a non-invasive manner, will affect clinical symptoms in adults suffering from ADHD. Concomitantly, we used EEG to characterize electrophysiological alterations induced by treatment and to search for correlation between baseline neuronal activity and clinical response. Forty-three drug free adults with ADHD were randomized to receive either Real, Active Control, or Sham treatment (13 females, age ranging 21-46; n = 15, 14, 14, respectively), and underwent three weeks of daily high-frequency (18 Hz) stimulation sessions. We found that Real treatment was safe and resulted in significant improvement of symptoms (η 2 p  = 0.34; Cohen's d (against Sham)  = 0.96; Cohen's d (against AC)  = 0.68; p = 0.00085). Furthermore, based on EEG recorded within the first treatment session we established a novel biomarker, composed of the Alpha and Low-gamma power, which highly correlated the magnitude of the clinical outcome (r = 0.92, p = 0.0001). Taken together, the results of this pilot study indicate safety and effectiveness of rTMS directed to the rPFC for treatment of adult ADHD patients. The biomarker is suggested to reflect the responsiveness of the cortex to this rTMS intervention. Following validation of the results in larger samples, this study may represent a step towards a non-pharmacological treatment for adults with ADHD using EEG-based selection of optimal candidates for treatment.",2020,We found that Real treatment was safe and resulted in significant improvement of symptoms (η 2 p  = 0.34; Cohen's d (against Sham)  = 0.96; Cohen's d (against AC)  = 0.68; p = 0.00085).,"['Forty-three drug free adults with ADHD', 'adults suffering from ADHD', 'adult ADHD patients']","['Real, Active Control, or Sham treatment', 'repetitive transcranial magnetic stimulation (rTMS', 'rTMS']",['symptoms'],"[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0294365,We found that Real treatment was safe and resulted in significant improvement of symptoms (η 2 p  = 0.34; Cohen's d (against Sham)  = 0.96; Cohen's d (against AC)  = 0.68; p = 0.00085).,"[{'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Alyagon', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hamutal', 'Initials': 'H', 'LastName': 'Shahar', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Aviad', 'Initials': 'A', 'LastName': 'Hadar', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Barnea-Ygael', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Lazarovits', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hadar', 'Initials': 'H', 'LastName': 'Shalev', 'Affiliation': 'Psychiatry Department, Soroka Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: azangen@bgu.ac.il.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102206']
332,32086189,A cluster randomized controlled trial of the SoMe social media literacy body image and wellbeing program for adolescent boys and girls: Study protocol.,"Youth spend substantial time on social media, which can foster self-critical processes that increase risk of body dissatisfaction, disordered eating, and depressed mood. To date, there have been few investigations of interventions to decrease the negative impacts of social media engagement in adolescent boys and girls. This paper outlines the protocol for a cluster randomized controlled trial (RCT) of a four-lesson social media literacy program that was developed based on pilot results and aims to decrease body dissatisfaction, dietary restraint, and strategies to increase muscles. The RCT will be conducted with grades 7-8 students from Australian secondary schools. Using block randomization, grade levels within schools will be assigned to either the SoMe program (intervention) or health lessons as usual (control). Primary outcomes will be body satisfaction, dietary restraint, and strategies to increase muscles. Secondary outcomes will be self-esteem and depressed mood. Participants will complete assessments on four occasions - baseline, five-weeks post-baseline, and six- and 12-month post-baseline. Analyses will compare outcomes in the intervention compared to the control group. This study will be the first to implement a RCT design to evaluate the impact of a school-based social media literacy program designed to mitigate negative impacts of social media.",2020,"This paper outlines the protocol for a cluster randomized controlled trial (RCT) of a four-lesson social media literacy program that was developed based on pilot results and aims to decrease body dissatisfaction, dietary restraint, and strategies to increase muscles.","['grades 7-8 students from Australian secondary schools', 'adolescent boys and girls']","['SoMe program (intervention) or health lessons as usual (control', 'SoMe social media literacy body image and wellbeing program']","['body satisfaction, dietary restraint, and strategies to increase muscles', 'self-esteem and depressed mood']","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}]",,0.0798022,"This paper outlines the protocol for a cluster randomized controlled trial (RCT) of a four-lesson social media literacy program that was developed based on pilot results and aims to decrease body dissatisfaction, dietary restraint, and strategies to increase muscles.","[{'ForeName': 'Chloe S', 'Initials': 'CS', 'LastName': 'Gordon', 'Affiliation': 'La Trobe University, Victoria, Australia. Electronic address: c.gordon@latrobe.edu.au.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Rodgers', 'Affiliation': 'Northeastern University, Boston, MA, USA; Department of Psychiatric Emergency & Acute Care, Lapeyronie Hospital, CHRU, Montpellier, France.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Slater', 'Affiliation': 'Centre for Appearance Research, University of West of England, Bristol, England, United Kingdom.'}, {'ForeName': 'Siân A', 'Initials': 'SA', 'LastName': 'McLean', 'Affiliation': 'La Trobe University, Victoria, Australia; Victoria University, Australia.'}, {'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'Jarman', 'Affiliation': 'La Trobe University, Victoria, Australia.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Paxton', 'Affiliation': 'La Trobe University, Victoria, Australia.'}]",Body image,['10.1016/j.bodyim.2020.02.003']
333,32166681,"Application of Low Tube Voltage, Low-concentration Contrast Agent Using a 320-row CT in Coronary CT Angiography: Evaluation of Image Quality, Radiation Dose and Iodine Intake.","The effect of low voltage and low concentration contrast agent on image quality of coronary CT angiography, radiation dose and iodine intake was evaluated. A total of 121 patients with body mass index (BMI) <26 kg/m 2  and heart rate (HR) <70 beats/min were randomly divided into four groups: group A (n=31, 80 kVp, 270 mgI/mL); group B (n=33, 100 kVp, 270 mgI/mL); group C (n=30, 100 kVp, 320 mgI/mL); group D (n=27, 100 kVp, 400 mgI/mL). The automatic current modulation system and the iterative algorithm for reconstruction were adopted in each group. The CT values and SD values of the aortic root (AR), subcutaneous fat, left coronary artery opening (LCA), and right coronary artery opening (RCA) were measured in all groups, the signal-to-noise ratio (SNR) and contrast noise ratio (CNR) were calculated, and effective radiation dose and iodine intake were recorded. The subjective assessment for image quality was performed by two physicians using a 4-point scale. The results were compared using the one-way ANOVA and rank sum tests. The image quality of the four groups met the clinical diagnostic requirements. The CT values of AR in groups A, B, C, and D were 537.6±71.4, 447.2±81.9, 445.2±64.9 and 518.5±94.9 Hu, respectively, with no significant difference between group A and group D, or between group B and group C, while CT values in groups B and C were significantly lower than those in groups A and D (P<0.05). In groups A, B, C, and D, the LCA SNR values were 22.7±9.1, 23.3±9.1, 23.3±7.7 and 26.6±8.9, and the RCA CNR values were 26.9±9.8, 28.5±11.4, 27.7±8.8 and 32.1±10.6, respectively. The AR visual scores in groups A, B, C and D were 3.8±0.2, 3.9±0.3, 3.9±0.3 and 4.0±0.3, respectively. There were no significant differences in SNR, CNR and visual score among the four groups (P>0.05). The radiation doses in groups A, B, C and D were 2.6±1.4, 3.6±1.8, 4.9±3.5 and 4.9±2.8 mSv, respectively. The radiation dose in group A was significantly less than that in the rest three groups (P<0.05). The iodine intakes in groups A, B, C and D were 14.9±1.5, 15.0±1.5, 17.7±2.0 and 18.1±2.5 g, respectively. There was no significant difference in the intake of iodine between groups C and D, or between groups A and B, while iodine intake in groups A and B were significantly reduced as compared with that in groups C and D (P<0.05). It was concluded that for patients with low BMI and controlled HR, compared to 100 kVp tube voltage combined with multiple concentration contrast agents, 80 kVp combined with 270 mgI/mL contrast agent is enough to ensure the quality of the images, and can reduce the radiation dose significantly, while reducing the amount of iodine intake notably, thus reducing the incidence of adverse reaction.",2020,The radiation dose in group A was significantly less than that in the rest three groups (P<0.05).,['121 patients with body mass index (BMI) <26 kg/m 2  and heart rate (HR) <70 beats/min'],['low voltage and low concentration contrast agent'],"['signal-to-noise ratio (SNR) and contrast noise ratio (CNR', 'CT values', 'LCA SNR values', 'CT values and SD values of the aortic root (AR), subcutaneous fat, left coronary artery opening (LCA), and right coronary artery opening (RCA', 'CT values of AR', 'RCA CNR values', 'SNR, CNR and visual score', 'effective radiation dose and iodine intake', 'intake of iodine', 'image quality of coronary CT angiography, radiation dose and iodine intake', 'AR visual scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}]","[{'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C1261082', 'cui_str': 'Left coronary artery structure'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0610301', 'cui_str': 'RCA II'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}]",121.0,0.0131779,The radiation dose in group A was significantly less than that in the rest three groups (P<0.05).,"[{'ForeName': 'Yue-Ying', 'Initials': 'YY', 'LastName': 'Pan', 'Affiliation': 'Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. xpyy02@sina.com.'}, {'ForeName': 'Shu-Chang', 'Initials': 'SC', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Yu-Jin', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Chun-Xia', 'Initials': 'CX', 'LastName': 'Liu', 'Affiliation': 'Department of Health Records, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Han-Xiong', 'Initials': 'HX', 'LastName': 'Guan', 'Affiliation': 'Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}]",Current medical science,['10.1007/s11596-020-2162-8']
334,32330694,Loading modality and age influence teriparatide-induced bone formation in the human femoral neck.,"Teriparatide (TPTD) reduces risk of both vertebral and nonvertebral fracture, but increases bone mineral density (BMD) much more at the spine than the hip. TPTD and mechanical loading may have a synergistic anabolic effect on BMD, which may help explain these site-specific differences. Under normal daily activity, the femoral neck (FN) is under bending, placing one side under tension and the other under compression. We sought to further understand the relationship between mechanical loading and TPTD at the hip by investigating the effect of tensile versus compressive loading on TPTD stimulated bone formation indices in the human FN. Thirty-eight patients receiving total hip replacements for osteoarthritis were randomized to receive placebo (PBO) or TPTD for a mean treatment duration of 6 weeks prior to surgery, and double tetracycline labeling was administered to allow assessment of bone formation. The FN was harvested during surgery and analyzed for dynamic bone formation indices in the compressive and tensile regions of the endocortical and periosteal envelopes. Regression models relating outcome measures to patient characteristics including sex, age, body weight, and FN geometry were also analyzed. Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface. The level of bone formation in both TPTD and placebo groups was greater on the tensile endocortical surface and the compressive periosteal surface. There was a trend toward decreased endocortical eroded surface with TPTD in the compressive but not the tensile region. Patient age and sex explained the greatest variability in endocortical bone formation, and patient body mass and sex explained the greatest variability in periosteal bone formation. Our data represent the first dynamic comparison of teriparatide treatment under two loading modalities in human FN samples. Future work could determine whether specific hip loading intervention could amplify the benefits of teriparatide on the hip in clinical settings.",2020,"Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface.","['Thirty-eight patients receiving total hip replacements for osteoarthritis', 'human femoral neck', 'human FN']","['teriparatide', 'TPTD versus placebo', 'placebo', 'tetracycline labeling', 'teriparatide-induced bone formation', 'Teriparatide (TPTD', 'placebo (PBO) or TPTD']","['level of bone formation', 'bone mineral density (BMD', 'tensile endocortical surface', 'bone formation', 'patient characteristics including sex, age, body weight, and FN geometry']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0449829', 'cui_str': 'Geometry'}]",38.0,0.027878,"Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface.","[{'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Rooney', 'Affiliation': 'Nancy E. and Peter C. Meinig School of Biomedical Engineering, Cornell University, 101 Weill Hall, Ithaca, NY 14853, USA. Electronic address: amr427@cornell.edu.'}, {'ForeName': 'Mathias P G', 'Initials': 'MPG', 'LastName': 'Bostrom', 'Affiliation': 'Research Division, Hospital for Special Surgery, 515 East 71st St., New York, NY 10021, USA. Electronic address: BostromM@hss.edu.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dempster', 'Affiliation': 'Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA; Department of Pathology, Columbia University, 630 West 168th St., New York, NY 10025, USA.'}, {'ForeName': 'Jeri W', 'Initials': 'JW', 'LastName': 'Nieves', 'Affiliation': 'Research Division, Hospital for Special Surgery, 515 East 71st St., New York, NY 10021, USA; Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA; Department of Epidemiology, Columbia University, 722 West 168th St., New York, NY 10032, USA. Electronic address: jwn5@cumc.columbia.edu.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA. Electronic address: zhouh@helenhayeshosp.org.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Department of Medicine, Columbia University, 622 West 168th St., New York, NY 10032, USA. Electronic address: fc14@cumc.columbia.edu.'}]",Bone,['10.1016/j.bone.2020.115373']
335,32330749,Human gut microbiome composition and tryptophan metabolites were changed differently by fast food and Mediterranean diet in 4 days: a pilot study.,"Diets rich in animal source foods vs plant-based diets have different macronutrient composition, and they have been shown to have differential effects on the gut microbiome. In this study, we hypothesized that diets with very different nutrient composition are able to change gut microbiome composition and metabolites in a very short period. We compared a fast food (FF) diet (ie, burgers and fries) with a Mediterranean (Med) diet, which is rich in vegetables, whole grains, olive oil, nuts, and fish. Ten healthy subjects participated in a controlled crossover study in which they consumed a Med diet and FF diet in randomized order for 4 days each, with a 4-day washout between treatments. Fecal DNA was extracted and the 16S V4 region amplified using polymerase chain reaction followed by sequencing on an Illumina MiSeq. Plasma metabolites and bile acids were analyzed using liquid chromatography-mass spectrometry. Certain bile-tolerant microbial genera and species including Collinsella, Parabacteroides, and Bilophila wadsworthia significantly increased after the FF diet. Some fiber-fermenting bacteria, including Lachnospiraceae and Butyricicoccus, increased significantly after the Med diet and decreased after the FF diet. Bacterially produced metabolites indole-3-lactic acid and indole-3-propionic acid, which have been shown to confer beneficial effects on neuronal cells, increased after the Med diet and decreased after the FF diet. Interindividual variability in response to the treatments may be related to differences in background diet, for example as shown by differences in Bilophila response in relationship to the saturated fat content of the baseline diet. In conclusion, an animal fat-rich, low-fiber FF diet v. a high-fiber Med diet altered human gut microbiome composition and its metabolites after just 4 days.",2020,"Some fiber-fermenting bacteria, including Lachnospiraceae and Butyricicoccus, increased significantly after the Med diet and decreased after the FF diet.",['Ten healthy subjects'],"['fast food (FF) diet (ie, burgers and fries) with a Mediterranean (Med) diet, which is rich in vegetables, whole grains, olive oil, nuts, and fish', 'Med diet and FF diet']","['Collinsella, Parabacteroides, and Bilophila wadsworthia', 'Plasma metabolites and bile acids']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0452929', 'cui_str': 'Burger'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C1047126', 'cui_str': 'Collinsella'}, {'cui': 'C1927848', 'cui_str': 'Parabacteroides'}, {'cui': 'C1005848', 'cui_str': 'Bilophila wadsworthia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}]",10.0,0.0227447,"Some fiber-fermenting bacteria, including Lachnospiraceae and Butyricicoccus, increased significantly after the Med diet and decreased after the FF diet.","[{'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: chhzhu@ucdavis.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sawrey-Kubicek', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: lsawreykubicek@ucdavis.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beals', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: egbeals@ucdavis.edu.'}, {'ForeName': 'Chris H', 'Initials': 'CH', 'LastName': 'Rhodes', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: chrhodes@ucdavis.edu.'}, {'ForeName': 'Hannah Eve', 'Initials': 'HE', 'LastName': 'Houts', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: hehouts@ucdavis.edu.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: rsacchi@ucdavis.edu.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: amzivkovic@ucdavis.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.03.005']
336,32151992,#Loveyourbody: The effect of body positive Instagram captions on women's body image.,"One increasing trend on social media is the posting of body positive content that aims to challenge narrow beauty ideals and instead promote acceptance and appreciation of all bodies. The aim of the present study was to experimentally investigate the effect of body positive captions attached to Instagram images on young women's body image. Participants were 384 women aged 18-30 years randomly assigned to view Instagram images of thin or average-sized women containing either body positive captions or no captions. In contrast to prediction, the body positive captions had no effect on body dissatisfaction or body appreciation. There was a significant effect of image type, whereby the average images resulted in less body dissatisfaction and greater body appreciation than the thin images. A significant three-way interaction indicated that for women high on thin-ideal internalisation, body positive captions on average images led to greater body appreciation, but lower body appreciation when attached to thin images. The results suggest that the visual imagery of an Instagram post is a more potent contributor to body image than any accompanying text. Presenting a more diverse array of women's bodies on social media is likely a more effective way to foster body satisfaction and appreciation.",2020,"There was a significant effect of image type, whereby the average images resulted in less body dissatisfaction and greater body appreciation than the thin images.","['Participants were 384 women aged 18-30 years randomly assigned to', ""young women's body image"", ""women's body image""]","['body positive captions attached to Instagram images', 'Loveyourbody', 'view Instagram images of thin or average-sized women containing either body positive captions or no captions', 'body positive Instagram captions']","['body dissatisfaction and greater body appreciation', 'body dissatisfaction or body appreciation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",384.0,0.0408839,"There was a significant effect of image type, whereby the average images resulted in less body dissatisfaction and greater body appreciation than the thin images.","[{'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'Flinders University, Australia. Electronic address: Marika.Tiggemann@flinders.edu.au.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Anderberg', 'Affiliation': 'Flinders University, Australia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Brown', 'Affiliation': 'Flinders University, Australia.'}]",Body image,['10.1016/j.bodyim.2020.02.015']
337,32155576,Effect of intensive self-management education on seizure frequency and quality of life in epilepsy patients with prodromes or precipitating factors.,"PURPOSE


To explore the impact of an intensive self-management education strategy on seizure frequency and quality of life in patients with epileptic seizures with prodromes or precipitating factors. The intensive self-management education included monthly education sessions on prodromes and precipitating factors aiming to help patients to adopt self-management strategies.
METHODS


Adult patients with epilepsy (PWE) able to identify prodromes or precipitating factors of their seizures were randomly assigned to an intensive education group (IEG) (n = 45) or a regular education group(REG) (n = 47). All patients received a single face-to-face self-management education session at the time of enrollment. Both groups of patients received monthly telephone follow-up for 1 year. PWE in the IEG received intensive education during each follow-up call. Primary outcomes were seizure frequency, quality of life(Quality of life in epilepsy-31 inventory scores, QOLIE 31), and drug adherence(Morisky medication adherence scale,MMAS).
RESULTS


At the end of the 1-year follow-up period, seizure frequency in the IEG was significantly lower than at baseline (p < 0.001), but not in the REG(p = 0.085). Quality of life had improved significantly in the IEG (p < 0.001), but not in the REG (p = 0.073). Drug adherence was better in the IEG than in the REG (p = 0.003), and there were fewer accidental injuries in the IEG than the REG (p = 0.031).
CONCLUSIONS


In PWE aware of seizure prodromes or precipitating factors, intensive self-management education may reduce seizure frequency, improve quality of life, increase adherence with antiepileptic medication and reduce accidental injuries caused by seizures.",2020,"Quality of life had improved significantly in the IEG (p < 0.001), but not in the REG (p = 0.073).","['Adult patients with epilepsy (PWE) able to identify prodromes or precipitating factors of their seizures', 'patients with epileptic seizures with prodromes or precipitating factors', 'epilepsy patients with prodromes or precipitating factors']","['intensive self-management education strategy', 'intensive education group (IEG) (n = 45) or a regular education group(REG', 'intensive self-management education']","['seizure frequency in the IEG', 'seizure frequency and quality of life', 'Drug adherence', 'quality of life', 'accidental injuries', 'seizure frequency, quality of life(Quality of life in epilepsy-31 inventory scores, QOLIE 31), and drug adherence(Morisky medication adherence scale,MMAS', 'Quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0240805', 'cui_str': 'Prodrome'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C4317109', 'cui_str': 'Epileptic Seizures'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0151736', 'cui_str': 'Accidental injury (disorder)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0222045'}]",47.0,0.0654244,"Quality of life had improved significantly in the IEG (p < 0.001), but not in the REG (p = 0.073).","[{'ForeName': 'Meiling', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': ""Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Chengdu, Sichuan Province 610072, China.""}, {'ForeName': 'Chenqi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Chengdu, Sichuan Province 610072, China.""}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Chengdu, Sichuan Province 610072, China.""}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Chengdu, Sichuan Province 610072, China.""}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Chengdu, Sichuan Province 610072, China. Electronic address: shb1369@aliyun.com.""}]",Seizure,['10.1016/j.seizure.2020.03.003']
338,32174482,Transfer and retention effects of gait training with anterior-posterior perturbations to postural responses after medio-lateral gait perturbations in older adults.,"BACKGROUND


Gait perturbations, occurring in any direction in daily life, may result in a fall. In fall prevention, gait perturbation training is a promising approach. Treadmill perturbations in anterior-posterior direction can easily be applied by accelerations or decelerations of the belt, but it is unknown whether training effects transfer to reactive recovery in medio-lateral direction. We aimed to evaluate the transfer and retention effects of gait training with treadmill perturbations in anterior-posterior direction to medio-lateral reactive recovery.
METHODS


30 community dwelling older adults (>65 years) participated in this study. They were randomly assigned to a treadmill training session either with 16 anterior-posterior perturbations or with treadmill walking. The assessments contained a walking trial with 4 anterior-posterior and 4 medio-lateral perturbations. Deviations in trunk velocity from unperturbed walking were summed over the first three strides after perturbation as a measure of recovery.
FINDINGS


An exposure to gait perturbations during the baseline assessment led to significant improvement of recovery responses. For anterior-posterior perturbations, both groups showed better recovery immediately and 1-week post-intervention, and no group x time interaction was found.. For medio-lateral perturbations, both groups showed better recovery immediately and 1-week post-intervention, and again no group × time interaction.
INTERPRETATION


Baseline assessment with perturbations in anterior-posterior and medio-lateral directions caused significant improvements that were retained. Short-term training can be effective in dynamic stabilization of one's trunk, but our findings do not exclude that multi-directional perturbations may be needed.",2020,"For medio-lateral perturbations, both groups showed better recovery immediately and 1-week post-intervention, and again no group × time interaction.
","['30 community dwelling older adults (>65\xa0years', 'older adults']","['treadmill training session either with 16 anterior-posterior perturbations or with treadmill walking', 'gait training', 'gait training with anterior-posterior perturbations', 'gait perturbation training']",['recovery responses'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],30.0,0.0321226,"For medio-lateral perturbations, both groups showed better recovery immediately and 1-week post-intervention, and again no group × time interaction.
","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Rieger', 'Affiliation': 'Department of Human Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Van der Boechorststraat 7, 1081 BT Amsterdam, Amsterdam, the Netherlands; Motek Medical BV, Hogehilweg 18C, 1101 CD Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Papegaaij', 'Affiliation': 'Motek Medical BV, Hogehilweg 18C, 1101 CD Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pijnappels', 'Affiliation': 'Department of Human Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Van der Boechorststraat 7, 1081 BT Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Steenbrink', 'Affiliation': 'Motek Medical BV, Hogehilweg 18C, 1101 CD Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'van Dieën', 'Affiliation': 'Department of Human Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Van der Boechorststraat 7, 1081 BT Amsterdam, Amsterdam, the Netherlands. Electronic address: j.van.dieen@vu.nl.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.104988']
339,32333564,"Effects of robot-assisted gait training combined with virtual reality on motor and cognitive functions in patients with multiple sclerosis: A pilot, single-blind, randomized controlled trial.","BACKGROUND


Studies on robot-assisted gait training rehabilitation in multiple sclerosis have reported positive effects on mobility and quality of life. However, their effects on cognitive functions are difficult to determine because not all trials have included cognition assessments. Virtual reality-based training provides enhanced opportunity for stimulating cognitive abilities by repetitive practice, feedback information, and motivation for endurance practice.
OBJECTIVE


To compare the effects of innovative robot-assisted gait training combined with virtual reality versus standard robot-assisted gait training on information processing speed, sustained attention, working memory, and walking endurance in patients with multiple sclerosis.
METHODS


Seventeen outpatients were randomly assigned to receive robot-assisted gait training either with or without virtual reality. The robot assisted gait training + virtual reality group underwent end-effector system training engendered by virtual reality. The standard training group underwent end-effector system training. A blinded rater evaluated patients before and after treatment and at one month follow-up. The outcome measures were the Paced Auditory Serial Addition Test, Phonemic Fluency Test, Novel Task, Digit Symbol, Multiple Sclerosis Quality of Life-54, 2-Minutes Walk Test, 10-Meter Walking Test, Berg Balance Scale, gait analysis, and stabilometric assessment.
RESULTS


Between-group comparisons showed a significant change on the 2-Minutes Walk Test (p = 0.023) after treatment in the robot-assisted gait training + virtual reality group. Significant improvement were obtained also in executive functions (p = 0.012). Both gains were maintained at the 1-month follow-up evaluation (p = 0.012, p = 0.012) in the robot-assisted gait training + virtual reality group. Both group improved quality of life after treatment (Multiple Sclerosis Quality of Life-54: Mental Health p = 0.018, Physical Health p = 0.017).
CONCLUSIONS


Both training lead to positive influenced on executive functions. However larger positive effects on gait ability were noted after robot-assisted gait training engendered by virtual reality with multiple sclerosis. Robot-assisted gait training provides a therapeutic alternative and motivational of traditional motor rehabilitation.",2020,"RESULTS


Between-group comparisons showed a significant change on the 2-Minutes Walk Test (p = 0.023) after treatment in the robot-assisted gait training + virtual reality group.","['patients with multiple sclerosis', 'Seventeen outpatients']","['standard training group underwent end-effector system training', 'robot-assisted gait training either with or without virtual reality', 'robot-assisted gait training combined with virtual reality', 'Virtual reality-based training', 'Robot-assisted gait training', 'innovative robot-assisted gait training combined with virtual reality versus standard robot-assisted gait training', 'robot assisted gait training + virtual reality group underwent end-effector system training engendered by virtual reality', 'robot-assisted gait training rehabilitation']","['executive functions', 'mobility and quality of life', 'motor and cognitive functions', 'Paced Auditory Serial Addition Test, Phonemic Fluency Test, Novel Task, Digit Symbol, Multiple Sclerosis Quality of Life-54, 2-Minutes Walk Test, 10-Meter Walking Test, Berg Balance Scale, gait analysis, and stabilometric assessment', '2-Minutes Walk Test', 'quality of life', 'information processing speed, sustained attention, working memory, and walking endurance', 'gait ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0589060', 'cui_str': 'Paced auditory serial addition test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",17.0,0.0398956,"RESULTS


Between-group comparisons showed a significant change on the 2-Minutes Walk Test (p = 0.023) after treatment in the robot-assisted gait training + virtual reality group.","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Munari', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fonte', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Varalta', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Battistuzzi', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cassini', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Anna Paola', 'Initials': 'AP', 'LastName': 'Montagnoli', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Marialuisa', 'Initials': 'M', 'LastName': 'Gandolfi', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Modenese', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Filippetti', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Picelli', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}]",Restorative neurology and neuroscience,['10.3233/RNN-190974']
340,32317700,"Neck-specific exercise for radiating pain and neurological deficits in chronic whiplash, a 1-year follow-up of a randomised clinical trial.","Up to 90% of people with neurological deficits following whiplash injury report chronic symptoms. A recent unique study of neck-specific exercise showed positive results (post-intervention at 12 weeks), regarding arm pain and neurological deficits in people with chronic whiplash associated disorders (WAD). This 1-year follow-up of that randomised controlled study with assessor blinding aimed to examine whether neck-specific exercise with (NSEB) or without (NSE) a behavioural approach has long-term benefits over physical activity prescription (PPA) regarding arm pain and neurological deficits (n = 171). Interventions were: NSE, NSEB, or PPA. Follow-up of arm pain, paraesthesia bothersomeness (questionnaires) and clinical neurological tests were performed after 3, 6 and 12 months and analysed with Linear Mixed Models and General Estimating Equations. The NSE and/or NSEB groups reported significantly less pain and paraesthesia bothersomeness as well as higher odds of normal key muscle arm strength and of normal upper limb neural tension over the year (all p < 0.03), compared with PPA. In conclusion, results suggest that neck-specific exercise with or without a behavioural approach may have persisting long term benefits over PPA regarding arm pain and clinical signs associated with neurological deficits in chronic WAD.",2020,"The NSE and/or NSEB groups reported significantly less pain and paraesthesia bothersomeness as well as higher odds of normal key muscle arm strength and of normal upper limb neural tension over the year (all p < 0.03), compared with PPA.",['people with chronic whiplash associated disorders (WAD'],"['neck-specific exercise with (NSEB) or without (NSE', 'neck-specific exercise', 'Neck-specific exercise']","['Follow-up of arm pain, paraesthesia bothersomeness (questionnaires) and clinical neurological tests', 'pain and paraesthesia bothersomeness', 'normal key muscle arm strength and of normal upper limb neural tension']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0043145', 'cui_str': 'Whiplash injury to neck'}, {'cui': 'C1292726', 'cui_str': 'Associated disorder'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0233494', 'cui_str': 'Tension'}]",,0.0665411,"The NSE and/or NSEB groups reported significantly less pain and paraesthesia bothersomeness as well as higher odds of normal key muscle arm strength and of normal upper limb neural tension over the year (all p < 0.03), compared with PPA.","[{'ForeName': 'Maria Landén', 'Initials': 'ML', 'LastName': 'Ludvigsson', 'Affiliation': 'Department of Health Medicine and Caring Sciences, Division of Prevention Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, Linköping, Sweden. Maria.Landen.Ludvigsson@liu.se.'}, {'ForeName': 'Gunnel', 'Initials': 'G', 'LastName': 'Peterson', 'Affiliation': 'Department of Health Medicine and Caring Sciences, Division of Prevention Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Peolsson', 'Affiliation': 'Department of Health Medicine and Caring Sciences, Division of Prevention Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, Linköping, Sweden.'}]",Scientific reports,['10.1038/s41598-020-62722-4']
341,31446142,Implementing electronic substance use disorder and depression and anxiety screening and behavioral interventions in primary care clinics serving people with HIV: Protocol for the Promoting Access to Care Engagement (PACE) trial.,"BACKGROUND


Substance use disorders (SUDs) and psychiatric disorders are common among people with HIV (PWH) and lead to poor outcomes. Yet these conditions often go unrecognized and untreated in primary care.
METHODS


The Promoting Access to Care Engagement (PACE) trial currently in process examines the impact of self-administered electronic screening for SUD risk, depression and anxiety in three large Kaiser Permanente Northern California primary care clinics serving over 5000 PWH. Screening uses validated measures (Tobacco, Alcohol, Prescription medication, and other Substance use [TAPS]; and the Adult Outcomes Questionnaire [AOQ], which includes the Patient Health Questionnaire [PHQ-9] and Generalized Anxiety Disorder [GAD-2]) delivered via three modalities (secure messaging, tablets in waiting rooms, and desktop computers in exam rooms). Results are integrated automatically into the electronic health record. Based on screening results and physician referrals, behavioral health specialists embedded in primary care initiate motivational interviewing- and cognitive behavioral therapy-based brief treatment and link patients to addiction and psychiatry clinics as needed. Analyses examine implementation (screening and treatment rates) and effectiveness (SUD, depression and anxiety symptoms; HIV viral control) outcomes using a stepped-wedge design, with a 12-month intervention phase implemented sequentially in the clinics, and a 24-month usual care period prior to implementation in each clinic functioning as sequential observational phases for comparison. We also evaluate screening and treatment costs and implementation barriers and facilitators.
DISCUSSION


The study examines innovative, technology-facilitated strategies for improving assessment and treatment in primary care. Results may help to inform substance use, mental health, and HIV services.
TRIAL REGISTRATION


NCT03217058.",2019,"Analyses examine implementation (screening and treatment rates) and effectiveness (SUD, depression and anxiety symptoms; HIV viral control) outcomes using a stepped-wedge design, with a 12-month intervention phase implemented sequentially in the clinics, and a 24-month usual care period prior to implementation in each clinic functioning as sequential observational phases for comparison.","['for SUD risk, depression and anxiety in three large Kaiser Permanente Northern California primary care clinics serving over 5000 PWH', 'people with HIV (PWH', 'primary care clinics serving people with HIV', 'primary care']","['anxiety screening and behavioral interventions', 'electronic screening', 'motivational interviewing- and cognitive behavioral therapy-based brief treatment']","['Patient Health Questionnaire [PHQ-9] and Generalized Anxiety Disorder [GAD-2]) delivered via three modalities (secure messaging, tablets in waiting rooms, and desktop computers in exam rooms', 'effectiveness (SUD, depression and anxiety symptoms; HIV viral control) outcomes']","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C4319610', 'cui_str': '5000 (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1742641', 'cui_str': 'Desktop computer (physical object)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0312021,"Analyses examine implementation (screening and treatment rates) and effectiveness (SUD, depression and anxiety symptoms; HIV viral control) outcomes using a stepped-wedge design, with a 12-month intervention phase implemented sequentially in the clinics, and a 24-month usual care period prior to implementation in each clinic functioning as sequential observational phases for comparison.","[{'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, 401 Parnassus Avenue, Box 0984, San Francisco, CA 94143, United States of America; Division of Research, Kaiser Permanente Northern California Region, 2000 Broadway, Oakland, CA 94612, United States of America. Electronic address: derek.satre@ucsf.edu.'}, {'ForeName': 'Alexandra N', 'Initials': 'AN', 'LastName': 'Anderson', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California Region, 2000 Broadway, Oakland, CA 94612, United States of America.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Leibowitz', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California Region, 2000 Broadway, Oakland, CA 94612, United States of America.'}, {'ForeName': 'Tory', 'Initials': 'T', 'LastName': 'Levine-Hall', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California Region, 2000 Broadway, Oakland, CA 94612, United States of America.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Slome', 'Affiliation': 'Kasier Permanente Oakland Medical Center, 3801 Howe St, Oakland, CA 94611, United States of America.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Flamm', 'Affiliation': 'Kaiser Permanente Sacramento Medical Center, 2025 Morse Ave, Sacramento, CA 95825, United States of America.'}, {'ForeName': 'C Bradley', 'Initials': 'CB', 'LastName': 'Hare', 'Affiliation': 'Kaiser Permanente San Francisco Medical Center, 2238 Geary Blvd, San Francisco, CA 94115, United States of America.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McNeely', 'Affiliation': 'New York University School of Medicine, 550 1st Ave., New York, NY 10016, United States of America.'}, {'ForeName': 'Constance M', 'Initials': 'CM', 'LastName': 'Weisner', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, 401 Parnassus Avenue, Box 0984, San Francisco, CA 94143, United States of America; Division of Research, Kaiser Permanente Northern California Region, 2000 Broadway, Oakland, CA 94612, United States of America.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Horberg', 'Affiliation': 'Mid-Atlantic Permanente Research Institute, Kaiser Permanente Mid-Atlantic States, 2101 East Jefferson, Rockville, MD 20852, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Volberding', 'Affiliation': 'AIDS Research Institute, University of California San Francisco, San Francisco, CA, 94158, United States of America.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Silverberg', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California Region, 2000 Broadway, Oakland, CA 94612, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105833']
342,31972397,Creative music therapy to promote brain function and brain structure in preterm infants: A randomized controlled pilot study.,"Cognitive and neurobehavioral problems are among the most severe adverse outcomes in very preterm infants. Such neurodevelopmental impairments may be mitigated through nonpharmacological interventions such as creative music therapy (CMT), an interactive, resource- and needs-oriented approach that provides individual social contact and musical stimulation. The aim was to test the feasibility of a study investigating the role of CMT and to measure the short- and medium-term effects of CMT on structural and functional brain connectivity with MRI. In this randomized, controlled clinical pilot feasibility trial, 82 infants were randomized to either CMT or standard care. A specially trained music therapist provided CMT via infant-directed humming and singing in lullaby style. To test the short-term effects of CMT on brain structure and function, diffusion tensor imaging data and resting-state functional imaging data were acquired. Clinical feasibility was achieved despite moderate parental refusal mainly in the control group after randomization. 40 infants remained as final cohort for the MRI analysis. Structural brain connectivity appears to be moderately affected by CMT, structural connectomic analysis revealed increased integration in the posterior cingulate cortex only. Lagged resting-state MRI analysis showed lower thalamocortical processing delay, stronger functional networks, and higher functional integration in predominantly left prefrontal, supplementary motor, and inferior temporal brain regions in infants treated with CMT. This trial provides unique evidence that CMT has beneficial effects on functional brain activity and connectivity in networks underlying higher-order cognitive, socio-emotional, and motor functions in preterm infants. Our results indicate the potential of CMT to improve long-term neurodevelopmental outcomes in children born very preterm.",2020,"Structural brain connectivity appears to be moderately affected by CMT, structural connectomic analysis revealed increased integration in the posterior cingulate cortex only.","['very preterm infants', '40 infants remained as final cohort for the MRI analysis', 'children born very preterm', '82 infants', 'preterm infants']","['CMT or standard care', 'CMT', 'Creative music therapy']","['brain structure and function, diffusion tensor imaging data and resting-state functional imaging data']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0026868', 'cui_str': 'Music Therapy'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",82.0,0.173841,"Structural brain connectivity appears to be moderately affected by CMT, structural connectomic analysis revealed increased integration in the posterior cingulate cortex only.","[{'ForeName': 'Friederike Barbara', 'Initials': 'FB', 'LastName': 'Haslbeck', 'Affiliation': 'Department of Neonatology, University Hospital Zurich and University Zurich, Frauenklinikstrasse 10, 8091 Zürich, Switzerland. Electronic address: friederike.haslbeck@usz.ch.'}, {'ForeName': 'Andras', 'Initials': 'A', 'LastName': 'Jakab', 'Affiliation': ""MR Research Center, University Children's Hospital Zurich, Steinwiesstrasse 75, 8032 Zürich, Switzerland.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Held', 'Affiliation': 'Department of Biostatistics Epidemiology, Biostatistics and Prevention Institute UZH, Hirschengraben 84, 8001 Zürich, Switzerland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Bassler', 'Affiliation': 'Department of Neonatology, University Hospital Zurich and University Zurich, Frauenklinikstrasse 10, 8091 Zürich, Switzerland.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Bucher', 'Affiliation': 'Department of Neonatology, University Hospital Zurich and University Zurich, Frauenklinikstrasse 10, 8091 Zürich, Switzerland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Hagmann', 'Affiliation': ""Department of Neonatology and Pediatric Intensive Care, Children's University Hospital of Zurich, Steinwiesstrasse 75, 8032 Zürich, Switzerland; Children's Research Center, University Children's Hospital Zurich, Steinwiesstrasse 75, 8032 Zürich, Switzerland.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102171']
343,31978826,Hippocampal plasticity underpins long-term cognitive gains from resistance exercise in MCI.,"Dementia affects 47 million individuals worldwide, and assuming the status quo is projected to rise to 150 million by 2050. Prevention of age-related cognitive impairment in older persons with lifestyle interventions continues to garner evidence but whether this can combat underlying neurodegeneration is unknown. The Study of Mental Activity and Resistance Training (SMART) trial has previously reported within-training findings; the aim of this study was to investigate the long-term neurostructural and cognitive impact of resistance exercise in Mild Cognitive Impairment (MCI). For the first time we show that hippocampal subareas particularly susceptible to volume loss in Alzheimer's disease (AD) are protected by resistance exercise for up to one year after training. One hundred MCI participants were randomised to one of four training groups: (1) Combined high intensity progressive resistance and computerised cognitive training (PRT+CCT), (2) PRT+Sham CCT, (3) CCT+Sham PRT, (4) Sham physical+sham cognitive training (SHAM+SHAM). Physical, neuropsychological and MRI assessments were carried out at baseline, 6 months (directly after training) and 18 months from baseline (12 months after intervention cessation). Here we report neuro-structural and functional changes over the 18-month trial period and the association with global cognitive and executive function measures. PRT but not CCT or PRT+CCT led to global long-term cognitive improvements above SHAM intervention at 18-month follow-up. Furthermore, hippocampal subfields susceptible to atrophy in AD were protected by PRT revealing an elimination of long-term atrophy in the left subiculum, and attenuation of atrophy in left CA1 and dentate gyrus when compared to SHAM+SHAM (p = 0.023, p = 0.020 and p = 0.027). These neuroprotective effects mediated a significant portion of long-term cognitive benefits. By contrast, within-training posterior cingulate plasticity decayed after training cessation and was unrelated to long term cognitive benefits. Neither general physical activity levels nor fitness change over the 18-month period mediated hippocampal trajectory, demonstrating that enduring hippocampal subfield plasticity is not a simple reflection of post-training changes in fitness or physical activity participation. Notably, resting-state fMRI analysis revealed that both the hippocampus and posterior cingulate participate in a functional network that continued to be upregulated following intervention cessation. Multiple structural mechanisms may contribute to the long-term global cognitive benefit of resistance exercise, developing along different time courses but functionally linked. For the first time we show that 6 months of high intensity resistance exercise is capable of not only promoting better cognition in those with MCI, but also protecting AD-vulnerable hippocampal subfields from degeneration for at least 12 months post-intervention. These findings emphasise the therapeutic potential of resistance exercise; however, future work will need to establish just how long-lived these outcomes are and whether they are sufficient to delay dementia.",2020,PRT but not CCT or PRT+CCT led to global long-term cognitive improvements above SHAM intervention at 18-month follow-up.,"['older persons with', 'One hundred MCI participants', 'Mild Cognitive Impairment (MCI']","['CCT or PRT+CCT', 'resistance exercise', 'Combined high intensity progressive resistance and computerised cognitive training (PRT+CCT), (2) PRT+Sham CCT, (3) CCT+Sham PRT, (4) Sham physical+sham cognitive training (SHAM+SHAM', 'lifestyle interventions']","['Physical, neuropsychological and MRI assessments']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0684562,PRT but not CCT or PRT+CCT led to global long-term cognitive improvements above SHAM intervention at 18-month follow-up.,"[{'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Broadhouse', 'Affiliation': 'Nola Thompson Centre for Advanced Imaging, Sunshine Coast Mind and Neuroscience Thompson Institute, University of the Sunshine Coast, QLD, Australia; Regenerative Neuroscience Group, Brain and Mind Centre and Sydney Medical School, The University of Sydney, Sydney, NSW, Australia. Electronic address: kbroadhouse@usc.edu.au.'}, {'ForeName': 'Maria Fiatarone', 'Initials': 'MF', 'LastName': 'Singh', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences and Sydney Medical School, The University of Sydney, Lidcombe, NSW, Australia; Hebrew SeniorLife and Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Suo', 'Affiliation': 'Regenerative Neuroscience Group, Brain and Mind Centre and Sydney Medical School, The University of Sydney, Sydney, NSW, Australia; School of Psychological Sciences and Monash Biomedical Imaging, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gates', 'Affiliation': 'Regenerative Neuroscience Group, Brain and Mind Centre and Sydney Medical School, The University of Sydney, Sydney, NSW, Australia; School of Psychiatry, University of New South Wales, Sydney, NSW, Australia; Centre for Healthy Brain Ageing, School of Psychiatry, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wen', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, NSW, Australia; Neuropsychiatric Institute, Prince of Wales Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Brodaty', 'Affiliation': 'Centre for Healthy Brain Ageing, School of Psychiatry, University of New South Wales, Sydney, NSW, Australia; Dementia Collaborative Research Centre, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Guy C', 'Initials': 'GC', 'LastName': 'Wilson', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Jacinda', 'Initials': 'J', 'LastName': 'Meiklejohn', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Nalin', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Bernhard T', 'Initials': 'BT', 'LastName': 'Baune', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baker', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences and Sydney Medical School, The University of Sydney, Lidcombe, NSW, Australia; School of Exercise Science, Australian Catholic University, Strathfield, NSW, Australia.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Foroughi', 'Affiliation': 'Clinical and Rehabilitation Research Group, Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Clinical and Rehabilitation Research Group, Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia; Department of Medicine and the Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Kochan', 'Affiliation': 'Centre for Healthy Brain Ageing, School of Psychiatry, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Ashton', 'Affiliation': 'Biomedical Sciences, Faculty of Health Sciences and Medicine, Bond University, QLD, Australia.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': ""Institute of Health and Biomedical Innovation, Queensland University of Technology, QLD, Australia; King's College London National Institutes of Health Biomedical Research Centre, UK.""}, {'ForeName': 'Zhixiu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, QLD, Australia.'}, {'ForeName': 'Yorgi', 'Initials': 'Y', 'LastName': 'Mavros', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences and Sydney Medical School, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Perminder S', 'Initials': 'PS', 'LastName': 'Sachdev', 'Affiliation': 'Centre for Healthy Brain Ageing, School of Psychiatry, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Valenzuela', 'Affiliation': 'Regenerative Neuroscience Group, Brain and Mind Centre and Sydney Medical School, The University of Sydney, Sydney, NSW, Australia; School of Medical Sciences, Sydney Medical School, University of Sydney, Sydney, NSW, Australia. Electronic address: michael.valenzuela@sydney.edu.au.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102182']
344,32194251,Slow release oral morphine versus methadone for opioid use disorder in the fentanyl era (pRESTO): Protocol for a non-inferiority randomized clinical trial.,"BACKGROUND


North America is facing an unprecedented public health crisis of opioid-related morbidity and mortality, increasingly as a result of the introduction of illicitly manufactured fentanyl into the street drug market. Although the treatment of opioid use disorder (OUD) is a key element in the response to the opioid overdose epidemic, currently available pharmacotherapies (e.g., methadone, buprenorphine) may not be acceptable to or effective in all patients. Available evidence suggests that slow-release oral morphine (SROM) has similar efficacy rates as methadone with respect to promoting abstinence, and with improvements in a number of patient-reported outcomes among persons using heroin. However, little is known about the relative effectiveness and acceptability of SROM compared to methadone in the context of fentanyl use. This study aims to address this research gap.
METHODS


pRESTO is a 24-week, open-label, two arm, non-inferiority, randomized controlled trial comparing SROM versus methadone for the treatment of OUD. Participants will be 298 clinically stable, non-pregnant adults with OUD, recruited from outpatient clinics in Vancouver, Canada, where the majority of the illicit opioids are contaminated with fentanyl. The primary outcome is suppression of illicit opioid use, measured by bi-weekly urine drug screens. Secondary outcomes include: treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness.
DISCUSSION


pRESTO will be among the first studies to evaluate treatment options for individuals primarily using synthetic street opioids, providing important evidence to guide treatment strategies for this population.",2020,"Secondary outcomes include: treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness.
","['Participants will be 298 clinically stable, non-pregnant adults with OUD, recruited from outpatient clinics in Vancouver, Canada, where the majority of the illicit opioids are contaminated with fentanyl']","['methadone, buprenorphine', 'methadone', 'morphine', 'morphine (SROM']","['suppression of illicit opioid use, measured by bi-weekly urine drug screens', 'efficacy rates', ' treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0205279', 'cui_str': 'Contaminated (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",298.0,0.110341,"Secondary outcomes include: treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness.
","[{'ForeName': 'M Eugenia', 'Initials': 'ME', 'LastName': 'Socias', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada. Electronic address: bccsu-es@bccsu.ubc.ca.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Wood', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Huiru', 'Initials': 'H', 'LastName': 'Dong', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Rupinder', 'Initials': 'R', 'LastName': 'Brar', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Paxton', 'Initials': 'P', 'LastName': 'Bach', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Fairbairn', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105993']
345,31042696,Effects of MDMA on attention to positive social cues and pleasantness of affective touch.,"The psychostimulant drug ±3,4-methylenedioxymethamphetamine (MDMA) reportedly produces distinctive feelings of empathy and closeness with others. MDMA increases social behavior in animal models and has shown promise in psychiatric disorders, such as autism spectrum disorder (ASD) and post-traumatic stress disorder (PTSD). How it produces these prosocial effects is not known. This behavioral and psychophysiological study examined the effects of MDMA, compared with the prototypical stimulant methamphetamine (MA), on two measures of social behavior in healthy young adults: (i) responses to socially relevant, ""affective"" touch, and (ii) visual attention to emotional faces. Men and women (N = 36) attended four sessions in which they received MDMA (0.75 or 1.5 mg/kg), MA (20 mg), or a placebo in randomized order under double-blind conditions. Responses to experienced and observed affective touch (i.e., being touched or watching others being touched) were assessed using facial electromyography (EMG), a proxy of affective state. Responses to emotional faces were assessed using electrooculography (EOG) in a measure of attentional bias. Subjective ratings were also included. We hypothesized that MDMA, but not MA, would enhance the ratings of pleasantness and psychophysiological responses to affective touch and increase attentional bias toward positive facial expressions. Consistent with this, we found that MDMA, but not MA, selectively enhanced ratings of pleasantness of experienced affective touch. Neither drug altered the ratings of pleasantness of observed touch. On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces. These results provide new evidence that MDMA can enhance the experience of positive social interactions; in this case, pleasantness of physical touch and attentional bias toward positive facial expressions. The findings are consistent with evidence that the prosocial effects are unique to MDMA relative to another stimulant. Understanding the behavioral and neurobiological processes underlying the distinctive social effects of MDMA is a key step to developing the drug for psychiatric disorders.",2019,"On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces.","['Men and women (N\u2009=\u200936) attended four sessions in which they received', 'healthy young adults']","['placebo', 'psychostimulant drug ±3,4-methylenedioxymethamphetamine (MDMA', 'MDMA', 'electrooculography (EOG', 'MA', 'prototypical stimulant methamphetamine (MA']","['ratings of pleasantness and psychophysiological responses to affective touch and increase attentional bias toward positive facial expressions', 'positive social cues and pleasantness of affective touch', 'Subjective ratings', 'ratings of pleasantness of observed touch', 'attention toward happy faces']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0013854', 'cui_str': 'EOG'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}]","[{'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]",,0.0389876,"On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces.","[{'ForeName': 'Anya K', 'Initials': 'AK', 'LastName': 'Bershad', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Mayo', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kathryne', 'Initials': 'K', 'LastName': 'Van Hedger', 'Affiliation': 'Department of Clinical Neurological Sciences, University of Western Ontario, London, ON, UK.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'McGlone', 'Affiliation': 'School of Natural Sciences and Psychology, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Susannah C', 'Initials': 'SC', 'LastName': 'Walker', 'Affiliation': 'School of Natural Sciences and Psychology, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA. hdew@uchicago.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0402-z']
346,32325164,Perineural Dextrose and Corticosteroid Injections for Ulnar Neuropathy at the Elbow: A Randomized Double-blind Trial.,"OBJECTIVE


To assess the effects of perineural corticosteroid and 5% dextrose water (D5W) injections in patients with mild to moderate ulnar neuropathy at the elbow (UNE).
DESIGN


Prospective, randomized, double-blind, controlled trial (6-month follow-up).
SETTING


Outpatients of local medical center settings.
PARTICIPANTS


Patients (N=36) with mild to moderate UNE were randomized, and 33 participants were included in the final data analysis.
INTERVENTIONS


Patients were administered a single perineural injection with 5 mL D5W and 3 mL corticosteroid (triamcinolone acetonide, 10mg/mL) mixed with 2 mL normal saline under ultrasound guidance in the dextrose and steroid groups, respectively.
MAIN OUTCOME MEASURES


The visual analog scale digital pain or paresthesia/dysesthesia score was the primary outcome. The secondary outcomes were the Disabilities of the Arm, Shoulder, and Hand questionnaire, motor nerve conduction velocity, and cross-sectional area (CSA) of the ulnar nerve. The measurement assessment was conducted before and 1, 3, 4, and 6 months after injection.
RESULTS


Thirty-three patients completed the study. Both injections were found to be equally effective at most measurement points, although the dextrose group experienced larger reductions in symptom severity and CSA of the ulnar nerve from the third month onward.
CONCLUSIONS


We suggest D5W as a more suitable injectate for perineural injection in patients with UNE.",2020,"Both injections were found to be equally effective at most measurement points, although the dextrose group experienced larger reductions in symptom severity and CSA of the ulnar nerve from the 3 rd  month onward.
","['ulnar neuropathy at the elbow', 'Outpatients of local medical center settings', 'Thirty-six patients with mild-to-moderate UNE were randomized and 33 participants were included in the final data analysis', 'patients with mild-to-moderate ulnar neuropathy at the elbow (UNE', 'Thirty-three patients completed the study']","['perineural corticosteroid and 5% dextrose water', 'Perineural dextrose and corticosteroid injections', 'single perineural injection with 5 mL D5W and 3 mL corticosteroid (10 mg/mL) mixed with 2 mL normal saline under ultrasound guidance in the dextrose and steroid groups, respectively']","['symptom severity and CSA of the ulnar nerve', 'dysesthesia score', 'Disabilities of the Arm, Shoulder, and Hand questionnaire, motor nerve conduction velocity, and cross-sectional area (CSA) of the ulnar nerve', 'visual analog scale digital pain or paresthesia']","[{'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0985452', 'cui_str': 'Glucose 50 MG/ML'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041602', 'cui_str': 'Structure of ulnar nerve'}, {'cui': 'C0241057', 'cui_str': 'Burning sensation of skin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0457379', 'cui_str': 'Motor nerve conduction velocity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}]",36.0,0.570527,"Both injections were found to be equally effective at most measurement points, although the dextrose group experienced larger reductions in symptom severity and CSA of the ulnar nerve from the 3 rd  month onward.
","[{'ForeName': 'Liang-Cheng', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Tsung-Yen', 'Initials': 'TY', 'LastName': 'Ho', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China; Department of Physical Medicine and Rehabilitation, Taichung Armed Forces General Hospital, Taichung City, Taiwan, Republic of China.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Shen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Su', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Tsung-Ying', 'Initials': 'TY', 'LastName': 'Li', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China; Integrated Pain Management Center, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Chia-Kuang', 'Initials': 'CK', 'LastName': 'Tsai', 'Affiliation': 'Department of Neurology, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China; Graduate Institute of Medical Science, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Yung-Tsan', 'Initials': 'YT', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China; Integrated Pain Management Center, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China. Electronic address: crwu98@gmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.016']
347,32325176,Effect of preparation design on the fracture behavior of ceramic occlusal veneers in maxillary premolars.,"OBJECTIVES


The fracture strengths of four types of occlusal veneers and a traditional full crown ceramic restoration and the influence of preparation design on the stress of restorations were examined.
METHODS


Forty intact maxillary premolars randomly divided into five groups were prepared based on the demands of type O (occlusal surface coverage), OF (occlusal and lingual surface coverage), POF (occlusal, lingual, and mesial surface coverage), and POFP (occlusal, lingual, mesial, and distal surface coverage) veneers and full crown, and then restored by glass ceramic. Specimens were subjected to fracture resistance tests after cyclic loading. The fracture strengths and modes were analyzed statistically. The level of significance was set at α = 0.05. One maxillary premolar was prepared for type O, OF, POF, POFP veneer and full crown, and then scanned to establish finite element models. The mean fracture load was applied vertically to calculate the maximum principal stress on the ceramic.
RESULTS


Type O veneer showed higher fracture strength than type POF and POFP veneers (P < 0.05). Both type O and OF veneers exhibited higher fracture strength than full crown (P < 0.05). No significant difference in failure mode was observed. The maximum principal stress for type O, OF, POF, POFP veneers, and full crown increased progressively and concentrated at the bonding surface directly beneath the loading area.
CONCLUSIONS


Four types of occlusal veneer showed fracture strengths that considerably exceeded normal biting forces. They represent conservative alternatives to full crowns and present a viable treatment for severely worn teeth.
CLINICAL SIGNIFICANCE


The occlusal veneers with different preparation designs, including type O, OF, POF and POFP veneers, show higher fracture resistances than traditional full coverage crowns that considerably exceed the normal biting forces. Therefore, these represent conservative alternatives to crown restorations and present a viable treatment for restoring severely worn teeth.",2020,Both type O and OF veneers exhibited higher fracture strength than full crown (P <  0.05).,"['Forty intact maxillary premolars', 'maxillary premolars']",[],"['fracture behavior of ceramic occlusal veneers', 'failure mode', 'maximum principal stress for type O, OF, POF, POFP veneers, and full crown', 'fracture strengths', 'fracture strength']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]",[],"[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0559953', 'cui_str': 'Veneer'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}]",40.0,0.0209738,Both type O and OF veneers exhibited higher fracture strength than full crown (P <  0.05).,"[{'ForeName': 'Xiaoqiong', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: huangxq36@mail2.sysu.edu.cn.""}, {'ForeName': 'Leiyan', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: zouly5@mail2.sysu.edu.cn.""}, {'ForeName': 'Run', 'Initials': 'R', 'LastName': 'Yao', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Shuyi', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: shuyiwu@21cn.com.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: liy8@mail.sysu.edu.cn.""}]",Journal of dentistry,['10.1016/j.jdent.2020.103346']
348,32325257,"A multicentre, randomised trial comparing schedules of G-CSF (filgrastim) administration for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer.","BACKGROUND


The optimal duration of filgrastim as primary febrile neutropenia (FN) prophylaxis in early breast cancer patients is unknown, with 5, 7 or 10 days being commonly prescribed. This trial evaluates whether 5 days of filgrastim was non-inferior to 7/10 days.
PATIENTS AND METHODS


In this randomised, open-label trial, early breast cancer patients who were to receive filgrastim as primary FN prophylaxis were randomly allocated to 5 versus 7 versus 10 days of filgrastim for all chemotherapy cycles. A protocol amendment in November 2017 allowed subsequent patients (N = 324) to be randomised to either 5 or 7/10 days. The primary outcome was a composite of either FN or treatment-related hospitalisations. Secondary outcomes included chemotherapy dose reductions, delays and discontinuations. Analyses were carried out by per protocol (primary) and intention-to-treat, and the non-inferiority margin was set at 3% for the risk of having FN and/or hospitalisation per cycle of chemotherapy.
RESULTS


Patients (N = 466) were randomised to receive 5 (184, 39.5%), or 7/10 (282, 60.5%) days of filgrastim. In our primary analysis, the difference in risk of either FN or treatment-related hospitalisation per cycle was -1.52% [95% confidence interval (CI): -3.22% to 0.19%] suggesting non-inferiority of a 5-day filgrastim schedule compared with 7/10-days. The difference in events per cycle for FN was 0.11% (95% CI: -1.05 to 1.27) while for treatment-related hospitalisations it was -1.68% (95% CI: -2.73% to -0.63%). The overall proportions of patients having at least one occurrence of either FN or treatment-related hospitalisation were 11.8% and 14.96% for the 5- and 7/10-day groups, respectively (risk difference: -3.17%, 95% CI: -9.51% to 3.18%).
CONCLUSION


Five days of filgrastim was non-inferior to 7/10 days. Given the cost and toxicity of this agent, 5 days should be considered standard of care. CLINICALTRIALS.
GOV REGISTRATION


NCT02428114 and NCT02816164.",2020,The difference in events per cycle for FN was 0.11% (95%CI: -1.05 to 1.27) while for treatment-related hospitalisations it was -1.68% (95%CI: -2.73% to -0.63%).,"['early breast cancer (EBC) patients', 'Patient (N=466', 'November 2017 allowed subsequent patients (N=324', 'early stage breast cancer', 'EBC patients who were to receive filgrastim as primary FN prophylaxis']","['filgrastim', 'G-CSF (filgrastim']","['overall proportions of patients having at least one occurrence of either FN or treatment-related hospitalization', 'risk of either FN or treatment-related hospitalisation per cycle', 'events per cycle for FN', 'composite of either FN or treatment-related hospitalisations', 'chemotherapy dose reductions, delays, and discontinuations', 'febrile neutropenia']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.248534,The difference in events per cycle for FN was 0.11% (95%CI: -1.05 to 1.27) while for treatment-related hospitalisations it was -1.68% (95%CI: -2.73% to -0.63%).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada; Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address: mclemons@toh.ca.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Division of Clinical Epidemiology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Simos', 'Affiliation': 'The Stronach Regional Cancer Center, Newmarket, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mates', 'Affiliation': 'Cancer Centre of Southeastern Ontario, Kingston, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Cancer Centre of Southeastern Ontario, Kingston, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Califaretti', 'Affiliation': 'Grand River Regional Cancer Centre, Kitchener, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zibdawi', 'Affiliation': 'The Stronach Regional Cancer Center, Newmarket, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bahl', 'Affiliation': 'Grand River Regional Cancer Centre, Kitchener, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raphael', 'Affiliation': 'Department of Medical Oncology, Schulich School of Medicine & Dentistry, Western University and London Health Sciences Centre, London, Canada; Division of Medical Oncology, London Regional Cancer Program, Western University, London, Canada.'}, {'ForeName': 'M F K', 'Initials': 'MFK', 'LastName': 'Ibrahim', 'Affiliation': 'Thunder Bay Regional Health Research Institute, Thunder Bay, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fernandes', 'Affiliation': 'Department of Medical Oncology, Schulich School of Medicine & Dentistry, Western University and London Health Sciences Centre, London, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pitre', 'Affiliation': 'The Northeast Cancer Centre, Sudbury, Canada.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Aseyev', 'Affiliation': 'Thunder Bay Regional Health Research Institute, Thunder Bay, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stober', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vandermeer', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Saunders', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hutton', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Pond', 'Affiliation': 'McMaster University, Hamilton, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Awan', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hilton', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.005']
349,32326325,Circulating MicroRNA Levels Indicate Platelet and Leukocyte Activation in Endotoxemia Despite Platelet P2Y 12  Inhibition.,"There is evidence for the effects of platelet inhibition on innate immune activation. Circulating microRNAs (miRNAs) have been implicated as markers of platelet and leukocyte activation. In the present study, we assessed the effects of P2Y 12  inhibitors on platelet and leukocyte miRNAs during endotoxemia. Healthy volunteers were randomly assigned to receive oral ticagrelor ( n  = 10), clopidogrel ( n  = 8) or no drug ( n  = 8) for one week, followed by an intravenous bolus of 2 ng/kg endotoxin. Serum was collected at baseline, after one week of antiplatelet treatment and 6 and 24 h after endotoxin administration. MiRNAs were screened using LNA-based qPCR, followed by TaqMan-qPCR validation of candidates. Clinical validation was performed in 41 sepsis patients. Platelet-enriched miR-197, miR-223 and miR-223* were decreased in volunteers following antiplatelet therapy. Endotoxin increased platelet miRNAs, whilst the opposite effect was seen for leukocyte-enriched miR-150. Neither of these endotoxin-mediated effects were altered by P2Y 12  inhibitors. Sepsis patients with fatal outcomes ( n  = 12) had reduced miR-150 levels compared with survivors ( n  = 29). In conclusion, we show that miR-150 is downregulated in experimental endotoxemia and can predict survival in sepsis but is unaffected by P2Y 12  inhibition. While P2Y 12  inhibition reduces platelet-associated miRNAs in healthy volunteers, it fails to attenuate the response of platelet miRNAs to endotoxemia.",2020,Sepsis patients with fatal outcomes ( n  = 12) had reduced miR-150 levels compared with survivors ( n  = 29).,"['41 sepsis patients', 'Endotoxemia', 'healthy volunteers', 'Healthy volunteers', 'Sepsis patients with fatal outcomes ( n  = 12']","['oral ticagrelor', 'clopidogrel ( n  = 8) or no drug ( n  = 8) for one week, followed by an intravenous bolus of 2 ng/kg endotoxin', 'Endotoxin']",['reduced miR-150 levels'],"[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376618', 'cui_str': 'Endotoxemia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0206277', 'cui_str': 'Fatal Outcome'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1638318', 'cui_str': 'ng/kg'}, {'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",41.0,0.0786613,Sepsis patients with fatal outcomes ( n  = 12) had reduced miR-150 levels compared with survivors ( n  = 29).,"[{'ForeName': 'Aitana', 'Initials': 'A', 'LastName': 'Braza-Boïls', 'Affiliation': ""King's British Heart Foundation Centre, King's College London, London SE5 9NU, UK.""}, {'ForeName': 'Temo', 'Initials': 'T', 'LastName': 'Barwari', 'Affiliation': ""King's British Heart Foundation Centre, King's College London, London SE5 9NU, UK.""}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Gutmann', 'Affiliation': ""King's British Heart Foundation Centre, King's College London, London SE5 9NU, UK.""}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Thomas', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Judge', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield S10 2RX, UK.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': ""King's British Heart Foundation Centre, King's College London, London SE5 9NU, UK.""}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Pechlaner', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck 6020, Austria.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Shankar-Hari', 'Affiliation': ""Critical Care Medicine, Guy's and St Thomas' NHS Foundation Trust, London SE1 7EH, UK.""}, {'ForeName': 'Ramzi A', 'Initials': 'RA', 'LastName': 'Ajjan', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Sabroe', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield S10 2RX, UK.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield S10 2RX, UK.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Mayr', 'Affiliation': ""King's British Heart Foundation Centre, King's College London, London SE5 9NU, UK.""}]",International journal of molecular sciences,['10.3390/ijms21082897']
350,32326347,"Efficacy of  Lactobacillus paracasei  HA-196 and  Bifidobacterium longum  R0175 in Alleviating Symptoms of Irritable Bowel Syndrome (IBS): A Randomized, Placebo-Controlled Study.","Specific probiotic strains can alleviate the gastrointestinal (GI) symptoms and psychiatric comorbidities of irritable bowel syndrome (IBS). In this randomized, double-blind, placebo-controlled study, the efficacy of  Lactobacillus paracasei  HA-196 ( L. paracasei ) and  Bifidobacterium longum  R0175 ( B. longum ) in reducing the GI and psychological symptoms of IBS was evaluated in 251 adults with either constipation (IBS-C), diarrhea (IBS-D), or mixed-pattern (IBS-M). Following a 2-week run-in period, participants were randomized to one of three interventions:  L. paracasei  ( n  = 84),  B. longum  ( n  = 83) or placebo ( n  = 81). IBS symptoms, stool frequency and consistency and quality of life were assessed by questionnaires. The differences from baseline in the severity of IBS symptoms at 4 and 8 weeks were similar between groups. Participants in this study were classified, after randomization, into subtypes according to Rome III. Within the  L. paracasei  group, complete spontaneous and spontaneous bowel movement frequency increased in participants with IBS-C ( n  = 10) after 8 weeks of supplementation (both  p  < 0.05) and decreased in participants with IBS-D ( n  = 10,  p  = 0.013). Both  L. paracasei  and  B. longum  supplementation improved the quality of life in emotional well-being and social functioning compared with baseline (all  p  < 0.05). In conclusion,  L. paracasei  and  B. longum  may reduce GI symptom severity and improve the psychological well-being of individuals with certain IBS subtypes.",2020,"Within the  L. paracasei  group, complete spontaneous and spontaneous bowel movement frequency increased in participants with IBS-C ( n  = 10) after 8 weeks of supplementation (both  p  < 0.05) and decreased in participants with IBS-D ( n  = 10,  p  = 0.013).","['251 adults with either constipation (IBS-C), diarrhea (IBS-D), or mixed-pattern (IBS-M', 'Irritable Bowel Syndrome (IBS']","['Lactobacillus paracasei  HA-196 ( L. paracasei ) and  Bifidobacterium longum  R0175 ( B. longum ', 'three interventions:  L. paracasei  ( n  = 84),  B. longum  ( n  = 83) or placebo', 'Specific probiotic strains', 'Placebo', 'placebo', 'Lactobacillus paracasei  HA-196 and  Bifidobacterium longum  R0175']","['IBS symptoms, stool frequency and consistency and quality of life', 'severity of IBS symptoms', 'GI symptom severity', 'quality of life in emotional well-being and social functioning', 'complete spontaneous and spontaneous bowel movement frequency']","[{'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C1564227', 'cui_str': 'Longum'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}]",251.0,0.195619,"Within the  L. paracasei  group, complete spontaneous and spontaneous bowel movement frequency increased in participants with IBS-C ( n  = 10) after 8 weeks of supplementation (both  p  < 0.05) and decreased in participants with IBS-D ( n  = 10,  p  = 0.013).","[{'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Lewis', 'Affiliation': 'KGK Science Inc., London, ON N6A 5R8, Canada.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Antony', 'Affiliation': 'KGK Science Inc., London, ON N6A 5R8, Canada.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Crowley', 'Affiliation': 'KGK Science Inc., London, ON N6A 5R8, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Piano', 'Affiliation': 'Lallemand Health Solutions, Montreal, QC H4P 2R2, Canada.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Bhardwaj', 'Affiliation': 'Lallemand Health Solutions, Montreal, QC H4P 2R2, Canada.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Tompkins', 'Affiliation': 'Lallemand Health Solutions, Montreal, QC H4P 2R2, Canada.'}, {'ForeName': 'Malkanthi', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'KGK Science Inc., London, ON N6A 5R8, Canada.'}]",Nutrients,['10.3390/nu12041159']
351,32326354,"Hot, Tired and Hungry: The Snacking Behaviour and Food Cravings of Firefighters During Multi-Day Simulated Wildfire Suppression.","Firefighters are exposed to numerous stressors during wildfire suppression, including working in hot temperatures and sleep restricted conditions. Research has shown that when sleep restricted, individuals choose foods higher in carbohydrates, fat, and sugar, and have increased cravings for calorie dense foods. However, there is currently no research on the combined effect of heat and sleep restriction on snacking behaviour. Conducting secondary analyses from a larger study, the current study aimed to investigate the impact of heat and sleep restriction on snacking behaviour and food cravings. Sixty-six firefighters completed three days of simulated physically demanding firefighting work and were randomly allocated to either the control ( n  = 18, CON; 19 °C, 8h sleep opportunity), sleep restricted ( n  = 16, SR; 19 °C, 4-h sleep opportunity), hot ( n  = 18, HOT; 33 °C, 8h sleep opportunity), or hot and sleep restricted ( n  = 14 HOT + SR; 33 °C, 4-h sleep opportunity) condition. During rest periods firefighters were able to self-select sweet, savoury, or healthy snacks from a ration pack and were asked to rate their hunger, fullness, and cravings every two hours (eating block). Mixed model analyses revealed no difference in total energy intake between conditions, however there was a significant interaction between eating block and condition, with those in the CON, HOT, and HOT + SR condition consuming significantly more energy between 1230 and 1430 compared to the SR condition ( p  = 0.002). Sleep restriction and heat did not impact feelings of hunger and fullness across the day, and did not lead to greater cravings for snacks, with no differences between conditions. These findings suggest that under various simulated firefighting conditions, it is not the amount of food that differs but the timing of food intake, with those that are required to work in hot conditions while sleep restricted more likely to consume food between 1230 and 1430. This has potential implications for the time of day in which a greater amount of food should be available for firefighters.",2020,"Sleep restriction and heat did not impact feelings of hunger and fullness across the day, and did not lead to greater cravings for snacks, with no differences between conditions.",['Sixty-six firefighters completed three days of simulated physically demanding firefighting work'],"['Hot, Tired and Hungry', 'heat and sleep restriction']","['total energy intake', 'Snacking Behaviour and Food Cravings of Firefighters', 'hunger and fullness', 'snacking behaviour and food cravings']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}]",,0.0175493,"Sleep restriction and heat did not impact feelings of hunger and fullness across the day, and did not lead to greater cravings for snacks, with no differences between conditions.","[{'ForeName': 'Charlotte C', 'Initials': 'CC', 'LastName': 'Gupta', 'Affiliation': 'School of Health, Medical and Applied Sciences, Central Queensland University, Adelaide 5034, Australia.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Ferguson', 'Affiliation': 'School of Health, Medical and Applied Sciences, Central Queensland University, Adelaide 5034, Australia.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Aisbett', 'Affiliation': 'Institute of Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong 3216, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Dominiak', 'Affiliation': 'School of Health, Medical and Applied Sciences, Central Queensland University, Adelaide 5034, Australia.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Chappel', 'Affiliation': 'Institute of Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong 3216, Australia.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Sprajcer', 'Affiliation': 'School of Health, Medical and Applied Sciences, Central Queensland University, Adelaide 5034, Australia.'}, {'ForeName': 'Hugh H K', 'Initials': 'HHK', 'LastName': 'Fullagar', 'Affiliation': 'University of Technology, Faculty of Health, Sydney 2007, Australia.'}, {'ForeName': 'Saman', 'Initials': 'S', 'LastName': 'Khalesi', 'Affiliation': 'School of Health, Medical and Applied Sciences, Central Queensland University, Adelaide 5034, Australia.'}, {'ForeName': 'Joshua H', 'Initials': 'JH', 'LastName': 'Guy', 'Affiliation': 'School of Health, Medical and Applied Sciences, Central Queensland University, Adelaide 5034, Australia.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Vincent', 'Affiliation': 'School of Health, Medical and Applied Sciences, Central Queensland University, Adelaide 5034, Australia.'}]",Nutrients,['10.3390/nu12041160']
352,32326511,An Explorative Analysis of  ABCG2/TOP-1  mRNA Expression as a Biomarker Test for FOLFIRI Treatment in Stage III Colon Cancer Patients: Results from Retrospective Analyses of the PETACC-3 Trial.,"Biomarker-guided treatment for patients with colon cancer is needed. We tested ABCG2 and topoisomerase 1 (TOP1) mRNA expression as predictive biomarkers for irinotecan benefit in the PETACC-3 patient cohort. The present study included 580 patients with mRNA expression data from Stage III colon cancer samples from the PETACC-3 study, which randomized the patients to Fluorouracil/leucovorin (5FUL) +/- irinotecan. The primary end-points were recurrence free survival (RFS) and overall survival (OS). Patients were divided into one group with high ABCG2 expression (above median) and low TOP-1 expression (below 75 percentile) (""resistant"") ( n  = 216) and another group including all other combinations of these two genes (""sensitive"") ( n  = 364). The rationale for the cut-offs were based on the distribution of expression levels in the PETACC-3 Stage II set of patients, where ABCG2 was unimodal and TOP1 was bimodal with a high expression level mode in the top quarter of the patients. Cox proportional hazards regression was used to estimate the hazard ratios and the association between variables and end-points and log-rank tests to assess the statistical significance of differences in survival between groups. Kaplan-Meier estimates of the survival functions were used for visualization and estimation of survival rates at specific time points. Significant differences were found for both RFS (Hazard ratio (HR): 0.63 (0.44-0.92);  p  = 0.016) and OS (HR: 0.60 (0.39-0.93);  p  = 0.02) between the two biomarker groups when the patients received FOLFIRI (5FUL+irinotecan). Considering only the Microsatellite Stable (MSS) and Microsatellite Instability-Low (MSI-L) patients ( n  = 470), the differences were even more pronounced. In contrast, no significant differences were observed between the groups when patients received 5FUL alone. This study shows that the combination of ABCG2 and TOP1 gene expression significantly divided the Stage III colon cancer patients into two groups regarding benefit from adjuvant treatment with FOLFIRI but not 5FUL.",2020,Significant differences were found for both RFS (Hazard ratio (HR): 0.63 (0.44-0.92);  p  = 0.016) and OS (HR: 0.60 (0.39-0.93);  ,"['580 patients with mRNA expression data from Stage III colon cancer samples from the PETACC-3 study, which randomized the patients to', 'Stage III Colon Cancer Patients', 'Stage III colon cancer patients', 'patients with colon cancer']","['5FUL', 'Fluorouracil/leucovorin (5FUL) ', 'FOLFIRI (5FUL+irinotecan', 'irinotecan']","['recurrence free survival (RFS) and overall survival (OS', 'survival rates']","[{'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0278480', 'cui_str': 'Carcinoma of colon, stage III'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",580.0,0.0389563,Significant differences were found for both RFS (Hazard ratio (HR): 0.63 (0.44-0.92);  p  = 0.016) and OS (HR: 0.60 (0.39-0.93);  ,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stenvang', 'Affiliation': 'Section of Molecular Disease Biology, Institute of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Budinská', 'Affiliation': 'RECETOX, Faculty of Science, Masarykova Univerzita, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'van Cutsem', 'Affiliation': 'Digestive Oncology Department, University Hospitals Leuven and KU Leuven, 3001 Leuven, Belgium.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Bosman', 'Affiliation': 'University Institute of Pathology, University of Lausanne, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Popovici', 'Affiliation': 'RECETOX, Faculty of Science, Masarykova Univerzita, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Brünner', 'Affiliation': 'Section of Molecular Disease Biology, Institute of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, 2100 Copenhagen, Denmark.'}]",Cancers,['10.3390/cancers12040977']
353,32272281,Benefits of a WeChat-based multimodal nursing program on early rehabilitation in postoperative women with breast cancer: A clinical randomized controlled trial.,"BACKGROUND


Primary treatments for early-stage breast cancer can cause adverse effects, such as pain, fatigue, and sleep disturbance, that can markedly affect the patients' health-related quality of life.
OBJECTIVE


This study aimed to evaluate the benefits of a WeChat-based multimodal nursing program on early rehabilitation in postoperative women with breast cancer.
DESIGN


Clinical randomized controlled trial.
SETTING


Surgical breast cancer department of a general hospital in Shaanxi Province, China.
PARTICIPANTS


Women with breast cancer were recruited via convenience sampling. The inclusion criteria were (1) age ≥18 years, (2) newly diagnosed with breast cancer, (3) stage I-III disease, and (4) indicated for surgery with adjuvant therapy. Exclusion criteria were (1) comorbidity with other malignant tumors and infections and (2) cognitive or psychiatric disorders.
METHODS


We recruited patients with breast cancer and randomly allocated them to the intervention (n = 56) and control (n = 55) groups. The former was subjected to the WeChat-based multimodal nursing program plus routine nursing care for 6 months, whereas the latter received only routine nursing care. The primary endpoint (health-related quality of life) and secondary endpoints (pain, fatigue, and sleep) were measured using the Functional Assessment of Cancer Therapy-Breast version 4.0 (FACT-Bv4.0) and the Numerical Rating Scale at 4 time points (i.e., pre-surgery and 1, 3, and 6 months post-surgery).
RESULTS


The intervention group had significantly improved total FACT-Bv4.0 scores owing to the effects of group (F = 16.28, P < 0.001), time (F = 28.82, P < 0.001), and group-time interaction (F = 5.35, P = 0.001). Similar improvements were also found in social/family well-being and functional well-being (P < 0.05). Emotional well-being was improved based on the effects of time (F = 42.12, P < 0.001) and group-time interaction (F = 10.20, P < 0.001). The 'breast cancer-specific subscale for additional concerns' was affected by group (F = 21.55, P < 0.001) and time (F = 28.96, P < 0.001), whereas physical well-being was only affected by time (F = 35.39, P < 0.001). Pain, fatigue, and sleep were not significantly influenced by group effects.
CONCLUSIONS


We found a significant improvement in the health-related quality of life of postoperative women with breast cancer who used the WeChat-based multimodal nursing program during early rehabilitation. This demonstrated that the program is an effective intervention for postoperative rehabilitation in such patients. Findings of the study will provide evidence for eHealth services in clinical and transitional nursing care.",2020,Similar improvements were also found in social/family well-being and functional well-being (P < 0.05).,"['postoperative women with breast cancer who used the WeChat-based multimodal nursing program during early rehabilitation', 'The inclusion criteria were (1) age ≥18 years, (2) newly diagnosed with breast cancer, (3) stage I-III disease, and (4) indicated for surgery with adjuvant therapy', 'Women with breast cancer were recruited via convenience sampling', 'Exclusion criteria were (1) comorbidity with other malignant tumors and infections and (2) cognitive or psychiatric disorders', 'Surgical breast cancer department of a general hospital in Shaanxi Province, China', 'postoperative women with breast cancer', 'patients with breast cancer']",['WeChat-based multimodal nursing program'],"['total FACT-Bv4.0 scores', 'Functional Assessment of Cancer Therapy-Breast version 4.0 (FACT-Bv4.0) and the Numerical Rating Scale', 'breast cancer-specific subscale for additional concerns', 'Pain, fatigue, and sleep', 'health-related quality of life', 'social/family well-being and functional well-being', 'primary endpoint (health-related quality of life) and secondary endpoints (pain, fatigue, and sleep']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",56.0,0.0989668,Similar improvements were also found in social/family well-being and functional well-being (P < 0.05).,"[{'ForeName': 'Kaina', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': ""School of Nursing, Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi 710061, China. Electronic address: zhoukaina@xjtu.edu.cn.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""School of Nursing, Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi 710061, China.""}, {'ForeName': 'Wenqian', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': ""School of Nursing, Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi 710061, China.""}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""School of Nursing, Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi 710061, China.""}, {'ForeName': 'Mengyue', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""School of Nursing, Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi 710061, China.""}, {'ForeName': 'Pingli', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': ""Surgical Breast Cancer Department, the First Affiliated Hospital of Xi'an Jiaotong University, No. 277 Yanta West Road, Xi'an, Shaanxi 710061, China.""}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Surgical Breast Cancer Department, the First Affiliated Hospital of Xi'an Jiaotong University, No. 277 Yanta West Road, Xi'an, Shaanxi 710061, China.""}, {'ForeName': 'Minjie', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""School of Nursing, Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi 710061, China.""}, {'ForeName': 'Jinghua', 'Initials': 'J', 'LastName': 'An', 'Affiliation': ""School of Nursing, Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi 710061, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""School of Nursing, Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi 710061, China. Electronic address: lijin@xjtu.edu.cn.""}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""School of Nursing, Xi'an Jiaotong University Health Science Centre, No. 76 Yanta West Road, Xi'an, Shaanxi 710061, China. Electronic address: roselee@xjtu.edu.cn.""}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103565']
354,31465756,Added Value of Gluteus Medius and Quadratus Lumborum Dry Needling in Improving Knee Pain and Function in Female Athletes With Patellofemoral Pain Syndrome: A Randomized Clinical Trial.,"OBJECTIVE


To compare the effects of exercise therapy alone and exercise therapy plus gluteus medius (GM) and quadratus lumbarum (QL) dry needling on pain and function in female athletes with patellofemoral pain (PFP).
DESIGN


Single-blind randomized controlled trial with follow-up.
SETTING


Physiotherapy clinic.
PARTICIPANTS


Convenience sample of female athletes with PFP (N=40), who were randomly assigned to the exercise therapy (Ex group) or exercise-therapy+dry needling (Ex+DN group) group.
INTERVENTIONS


The Ex group received exercise therapy for 4 weeks, and the Ex+DN group received exercise therapy in combination with dry needling directed at GM and QL trigger points for 4 weeks.
MAIN OUTCOME MEASURES


In all participants, pain intensity, function (Kujala score, modified star excursion balance test, step-down test), and QL and GM pressure pain threshold (PPT) were recorded at baseline and at 4 and 6 weeks after the start of treatment. Analysis of variance (2 groups×3 times) was used to compare within- and between-group differences.
RESULTS


The group versus time interaction effect was significant for all variables (P<.05). Both groups showed significant improvements in pain, function, and PPT at weeks 4 and 6 compared to baseline (P<.05). Between-groups comparisons showed significantly greater improvements in pain, function, and PPT in the Ex+DN group (P<.05).
CONCLUSIONS


Targeting intervention to treat trigger points in the GM and QL muscles combined with exercise therapy had superior beneficial effects compared to exercise alone in managing PFP. Therefore, adding GM and QL muscle dry needling to exercise therapy may be advisable to enhance the effects of PFP rehabilitation.",2020,"Both groups showed significant improvements in pain, function and PPT at weeks 4 and 6 compared to baseline (P<0.05).","['female athletes with patellofemoral pain (PFP', '40 female athletes with PFP', 'female athletes with patellofemoral pain']","['exercise therapy', 'Ex+DN group received exercise therapy in combination with dry needling directed at GM and QL trigger points for 4 weeks', 'exercise therapy alone and exercise therapy plus gluteus medius (GM) and quadratus lumbarum (QL) dry needling', 'Exercise-therapy (Ex group) or Exercise-therapy + Dry needling (Ex+DN group) group', 'gluteus medius and quadratus lumborum dry needling']","['pain, function and PPT', 'pain and function', 'time interaction effect', 'pain intensity, function (Kujala score, modified star excursion balance test, step-down test), and QL and GM pressure pain threshold (PPT']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}]",40.0,0.132875,"Both groups showed significant improvements in pain, function and PPT at weeks 4 and 6 compared to baseline (P<0.05).","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Zarei', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Student Research Committee, Shiraz University of Medical Science, Shiraz, Iran.'}, {'ForeName': 'Soha', 'Initials': 'S', 'LastName': 'Bervis', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Student Research Committee, Shiraz University of Medical Science, Shiraz, Iran.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Piroozi', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Motealleh', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Rehabilitation Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: motealleh@sums.ac.ir.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.07.009']
355,31465757,"Effects of the Use of Anchor Systems in the Rehabilitation of Dynamic Balance and Gait in Individuals With Chronic Dizziness of Peripheral Vestibular Origin: A Single-Blinded, Randomized, Controlled Clinical Trial.","OBJECTIVE


To assess the effectiveness of the anchors in the balance rehabilitation of participants with chronic peripheral vestibulopathy who failed to respond positively to conventional rehabilitation for dynamic balance and gait.
DESIGN


Assessor-blind, randomized controlled trial.
SETTING


Department of Otoneurology and Laboratory of Assessment and Rehabilitation of Equilibrium.
PARTICIPANTS


Women with chronic dizziness of peripheral vestibular origin (N=42), who continued to show otoneurologic symptoms for more than 6 months after starting classic vestibular rehabilitation, with no clinical improvement observed.
INTERVENTIONS


Participants were randomly assigned to receive a clinical intervention with the anchor system, a clinical intervention without the anchor system, or no intervention or anchor system. The intervention was based on multi-sensory exercises for 6 weeks, twice a week, totaling 12 sessions, in groups of up to 4 participants, with an average time of 40 minutes per session.
MAIN OUTCOME MEASURES


The primary outcome was functional balance as assessed by the short version of the Balance Evaluation Systems Test. The secondary outcomes were gait parameters of step width in meters, step length in meters, and gait speed in meters per second. The measures were assessed preintervention and postintervention, and after a 3-month follow-up period.
RESULTS


The proposed intervention was beneficial for dizziness, balance, and gait for both groups studied. At the 3-month follow-up, only the group that used anchors retained the benefits related to the physical aspects of dizziness, balance, and gait.
CONCLUSIONS


The present study found that the proposed intervention protocol, with or without the use of anchors, was beneficial for improving the dizziness, balance, and gait. However, retention of the benefits achieved through the exercise protocol was observed only for those using the anchor system, which promotes the use of haptic information. The use of anchors was effective, in short protocols (12wk), with maintenance of results after 3 months.",2020,"At the 3-month follow-up, only the group that used anchors retained the benefits related to the physical aspects of dizziness, balance, and gait.
","['Department of Otoneurology and Laboratory of Assessment and Rehabilitation of Equilibrium', 'individuals with chronic dizziness of peripheral vestibular origin', 'Women with chronic dizziness of peripheral vestibular origin (n=42), who continued to show otoneurological symptoms for more than 6 months after starting classic VR, with no clinical improvement observed', 'participants with chronic peripheral vestibulopathy who failed to respond positively to conventional rehabilitation for dynamic balance and gait']","['clinical intervention with the anchor system, a clinical intervention without the anchor system, or no intervention or anchor system']","['gait parameters of step width (m), step length (m), and gait speed (m/sec).The measures', 'dizziness, balance, and gait', 'functional balance as assessed by the short version of the Balance Evaluation Systems Test (Mini-BESTest', 'physical aspects of dizziness, balance, and gait', 'AND FOLLOW-UP']","[{'cui': 'C3494416', 'cui_str': 'Otoneurology'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0014653', 'cui_str': 'Balance (observable entity)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.0586184,"At the 3-month follow-up, only the group that used anchors retained the benefits related to the physical aspects of dizziness, balance, and gait.
","[{'ForeName': 'Almir R', 'Initials': 'AR', 'LastName': 'Coelho', 'Affiliation': 'Department of Health Sciences of Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil; Department of Physiotherapy, University of Franca, Franca, Brazil. Electronic address: almir.resende@hotmail.com.'}, {'ForeName': 'Rafaela C', 'Initials': 'RC', 'LastName': 'Fontes', 'Affiliation': 'Department of Physiotherapy, University of Franca, Franca, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Moraes', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Camila de G C', 'Initials': 'CGC', 'LastName': 'Barros', 'Affiliation': 'Department of Health Sciences of Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Daniela C C', 'Initials': 'DCC', 'LastName': 'de Abreu', 'Affiliation': 'Department of Health Sciences of Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.07.012']
356,31562872,Randomized Controlled Trial of the Lateral Push-Off Skater Exercise for High-Intensity Interval Training vs Conventional Treadmill Training.,"OBJECTIVE


To examine the therapeutic effects of the lateral push-off skater exercise vs conventional treadmill training on health-related quality of life, cardiorespiratory fitness (CRF), and balance.
DESIGN


Single-blinded, randomized controlled trial.
SETTING


Outpatient clinic at a tertiary hospital.
PARTICIPANTS


Patients after minor stroke (N=36) with National Institutes of Health Stroke Scale scores≤3 between 20 and 65 years of age were randomly assigned to the intervention group (n=18) or the control group (n=18).
INTERVENTIONS


Thirty-minute sessions of the skater exercise were performed 3 times weekly for 12 weeks in the intervention group. Conventional treadmill aerobic exercise was conducted in the control group at the same frequency and duration as the experimental group exercise.
MAIN OUTCOME MEASURES


The primary outcome was measured using the European Quality of Life-5 Dimension (EQ-5D). Secondary outcomes included CRF and balance indicators. Assessments were performed at baseline (T0), 12 weeks from T0 (T1), and 16 weeks from T0 (T2).
RESULTS


Significant improvements in EQ-5D, peak oxygen uptake (VO 2 peak), peak oxygen pulse, peak minute ventilation (VE), Dynamic Gait Index (DGI), and Berg Balance Scale (BBS) were found in the intervention group after performing the skater exercise (P<.05, all), and these improvements were sustained at T2 (P<.05, all). Between-group comparisons demonstrated greater improvements in EQ-5D, VO 2 peak, peak oxygen pulse, peak VE, DGI, and BBS in the intervention group than those in the control group at both T1 (P<.05, all) and T2 (P<0.05, all). Correlation analysis showed significant relationships between EQ-5D and VO 2 peak, peak VE, DGI, and BBS (P<.05, all).
CONCLUSIONS


The skater exercise improved health-related quality of life, CRF, and balance in patients after minor stroke more effectively than conventional treadmill-based aerobic exercise. We recommend the skater exercise as a high-intensity interval training program for patients after minor stroke.",2020,"Between-group comparisons demonstrated greater improvements in EQ-5D, VO 2 peak, peak oxygen pulse, VEpeak, DGI, and BBS in the intervention group than those in the control group at both T1 (p<0.05, all) and T2 (p<0.05, all).","['minor stroke patients', 'Outpatient clinic at a tertiary hospital', 'Minor stroke patients with National Institutes of Health Stroke Scale scores of 3 or less between 20 and 65 years of age']","['High Intensity Interval Training versus Conventional Treadmill Training', 'conventional treadmill-based aerobic exercise', 'Conventional treadmill aerobic exercise', 'skater exercise versus conventional treadmill training', 'Lateral Push-Off Skater Exercise', 'skater exercise as a high-intensity interval training program', 'skater exercise']","['EQ-5D, peak oxygen uptake (VO 2 peak), peak oxygen pulse, peak minute ventilation (VEpeak), Dynamic Gait Index (DGI), and Berg Balance Scale (BBS', 'health-related quality of life, CRF, and balance', 'EQ-5D, VO 2 peak, peak oxygen pulse, VEpeak, DGI, and BBS', 'Euro-Quality of Life-5 Dimension (EQ-5D', 'CRF and balance indicators', 'health-related quality of life, cardiorespiratory fitness (CRF), and balance', 'EQ-5D and VO 2 peak, VEpeak, DGI, and BBS (p<0.05, all']","[{'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C1719958', 'cui_str': 'Push'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index (assessment scale)'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",,0.0736642,"Between-group comparisons demonstrated greater improvements in EQ-5D, VO 2 peak, peak oxygen pulse, VEpeak, DGI, and BBS in the intervention group than those in the control group at both T1 (p<0.05, all) and T2 (p<0.05, all).","[{'ForeName': 'Soo-Hyun', 'Initials': 'SH', 'LastName': 'Soh', 'Affiliation': 'Department of Rehabilitation Medicine, Wonkwang University School of Medicine and Institute of Wonkwang Medical Science, Iksan, Republic of Korea.'}, {'ForeName': 'Min Cheol', 'Initials': 'MC', 'LastName': 'Joo', 'Affiliation': 'Department of Rehabilitation Medicine, Wonkwang University School of Medicine and Institute of Wonkwang Medical Science, Iksan, Republic of Korea.'}, {'ForeName': 'Na Ri', 'Initials': 'NR', 'LastName': 'Yun', 'Affiliation': 'Department of Rehabilitation Medicine, Wonkwang University School of Medicine and Institute of Wonkwang Medical Science, Iksan, Republic of Korea.'}, {'ForeName': 'Min-Su', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Wonkwang University School of Medicine and Institute of Wonkwang Medical Science, Iksan, Republic of Korea. Electronic address: helmaine@naver.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.08.480']
357,32044712,Using connectivity-based real-time fMRI neurofeedback to modulate attentional and resting state networks in people with high trait anxiety.,"High levels of trait anxiety are associated with impaired attentional control, changes in brain activity during attentional control tasks and altered network resting state functional connectivity (RSFC). Specifically, dorsolateral prefrontal cortex to anterior cingulate cortex (DLPFC - ACC) functional connectivity, thought to be crucial for effective and efficient attentional control, is reduced in high trait anxious individuals. The current study examined the potential of connectivity-based real-time functional magnetic imaging neurofeedback (rt-fMRI-nf) for enhancing DLPFC - ACC functional connectivity in trait anxious individuals. We specifically tested if changes in DLPFC - ACC connectivity were associated with reduced anxiety levels and improved attentional control. Thirty-two high trait anxious participants were assigned to either an experimental group (EG), undergoing veridical rt-fMRI-nf, or a control group (CG) that received sham (yoked) feedback. RSFC (using resting state fMRI), anxiety levels and Stroop task performance were assessed pre- and post-rt-fMRI-nf training. Post-rt-fMRI-nf training, relative to the CG, the EG showed reduced anxiety levels and increased DLPFC-ACC functional connectivity as well as increased RSFC in the posterior default mode network. Moreover, in the EG, changes in DLPFC - ACC functional connectivity during rt-fMRI-nf training were associated with reduced anxiety levels. However, there were no group differences in Stroop task performance. We conclude that rt-fMRI-nf targeting DLPFC - ACC functional connectivity can alter network connectivity and interactions and is a feasible method for reducing trait anxiety.",2020,"Post-rt-fMRI-nf training, relative to the CG, the EG showed reduced anxiety levels and increased DLPFC-ACC functional connectivity as well as increased RSFC in the posterior default mode network.","['Thirty-two high trait anxious participants', 'people with high trait anxiety', 'trait anxious individuals']","['undergoing veridical rt-fMRI-nf, or a control group (CG) that received sham (yoked) feedback', 'connectivity-based real-time functional magnetic imaging neurofeedback (rt-fMRI-nf']","['anxiety levels', 'DLPFC - ACC functional connectivity', 'brain activity during attentional control tasks and altered network resting state functional connectivity (RSFC', 'Stroop task performance', 'anxiety levels and improved attentional control', 'anxiety levels and increased DLPFC-ACC functional connectivity', 'DLPFC - ACC connectivity', 'High levels of trait anxiety', 'anxiety levels and Stroop task performance']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",32.0,0.0137754,"Post-rt-fMRI-nf training, relative to the CG, the EG showed reduced anxiety levels and increased DLPFC-ACC functional connectivity as well as increased RSFC in the posterior default mode network.","[{'ForeName': 'Elenor', 'Initials': 'E', 'LastName': 'Morgenroth', 'Affiliation': 'Ecole Polytechnique Federale, Lausanne, Switzerland; Department of Psychology, University of Roehampton, Whitelands College, Hollybourne Avenue, London SW15 4JD, UK. Electronic address: Elenor.morgenroth@epfl.ch.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Saviola', 'Affiliation': 'CIMeC, Center for Mind/Brain Sciences, University of Trento, Rovereto (Trento), Italy.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gilleen', 'Affiliation': 'Department of Psychology, University of Roehampton, Whitelands College, Hollybourne Avenue, London SW15 4JD, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Allen', 'Affiliation': 'Department of Psychology, Royal Holloway University of London, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lührs', 'Affiliation': 'Research Department, Brain Innovation B.V., Maastricht, Netherlands; Department of Cognitive Neuroscience, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'W Eysenck', 'Affiliation': 'Department of Psychology, University of Roehampton, Whitelands College, Hollybourne Avenue, London SW15 4JD, UK; Department of Psychology, Royal Holloway University of London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Allen', 'Affiliation': ""Department of Psychology, University of Roehampton, Whitelands College, Hollybourne Avenue, London SW15 4JD, UK; Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK; Combined Universities Brain Imaging Centre, London, UK; Icahn School of Medicine, Mount Sinai Hospital, New York, NY, USA.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102191']
358,32298704,Pain-modulating effects of oxytocin in patients with chronic low back pain.,"The neuropeptide oxytocin (OT) has been shown to play a modulatory role in nociception. However, analgesic effects of OT in chronic pain conditions remain elusive and the neural underpinnings have not yet been investigated in humans. Here, we conducted an exploratory, randomized, placebo-controlled, cross-over study to examine effects of intranasal OT in male patients suffering from chronic low back pain (CBP) versus healthy controls (HC). N = 22 participants with CBP and 22 HCs were scanned using functional magnetic resonance imaging (fMRI) while they continuously rated either spontaneously occurring back pain or acute thermal pain stimuli applied to the lower back. During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs. Spontaneously experienced pain in contrast to heat pain was associated with activation changes in the medial frontal cortex (MFC) and the anterior cingulate cortex (ACC) as reported in previous studies. However, we did not observe OT effects on spontaneously experienced pain in CBP patients. Overall, our preliminary data may suggest that the striatum is a key structure underlying the pain-modulating effects of OT in patients with chronic pain and adds to the growing evidence linking the neuropeptide to pain modulation in humans. Further studies on neuronal OT effects in larger samples of chronic back pain patients are needed to understand probable mechanisms of OT effects in chronic pain. This article is part of the special issue on Neuropeptides.",2020,During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs.,"['N\u202f=\u202f22 participants with CBP and 22\u202fHCs', 'male patients suffering from chronic low back pain (CBP) versus healthy controls (HC', 'patients with chronic low back pain', 'chronic back pain patients', 'patients with chronic pain']","['neuropeptide oxytocin (OT', 'OT', 'OT versus PL', 'intranasal OT', 'placebo', 'functional magnetic resonance imaging (fMRI) while they continuously rated either spontaneously occurring back pain or acute thermal pain stimuli applied to the lower back', 'oxytocin']","['BOLD responses', 'pain intensity ratings', 'medial frontal cortex (MFC) and the anterior cingulate cortex (ACC', 'OT effects']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0004600', 'cui_str': 'Back'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",22.0,0.105867,During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs.,"[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Boll', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Ueltzhoeffer', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Roth', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bertsch', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany; Department of Psychology and Psychotherapy, Ludwigs-Maximilian-University München, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Department of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Nees', 'Affiliation': 'Department of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Grinevich', 'Affiliation': 'Department of Neuropeptide Research in Psychiatry, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Sabine C', 'Initials': 'SC', 'LastName': 'Herpertz', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany. Electronic address: Sabine.Herpertz@med.uni-heidelberg.de.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108105']
359,32302646,Acute stress affects implicit but not explicit motor imagery: A pilot study.,"Motor imagery (MI) is the capacity to mentally perform one or a set of movements without concomitant overt action. MI training has been show to enhance the subsequent motor performance. While the benefits of MI to manage stress have been extensively documented, the reverse impact of stress on MI received far less attention. The present study thus aimed to evaluate whether acute stress might influence MI abilities. Thirty participants were assigned either to a stress or a control group. The Socially Evaluated Cold Pressor Test (SECPT) was used to induce stress, with heart rate, electrodermal activity, salivary cortisol, and self-report perceived levels of stress being monitored during the experiment. Stress induction was followed by both implicit (laterality judgment) and explicit (sequential pointing) MI tasks. Main results showed a deleterious impact of stress on implicit MI, while explicit MI was not altered. These exploratory findings provide a deeper understanding of stress effects on cognition, and practically support that under stressful conditions, as during a sport competition or rehabilitation contexts, explicit MI should be prioritized.",2020,"Main results showed a deleterious impact of stress on implicit MI, while explicit MI was not altered.",['Thirty participants'],"['explicit motor imagery', 'Motor imagery (MI', 'MI training']","['induce stress, with heart rate, electrodermal activity, salivary cortisol, and self-report perceived levels of stress', 'deleterious impact of stress on implicit MI, while explicit MI']","[{'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]",30.0,0.0137573,"Main results showed a deleterious impact of stress on implicit MI, while explicit MI was not altered.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schlatter', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: sophie.schlatter@univ-lyon1.fr.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Guillot', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: aymeric.guillot@univ-lyon1.fr.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Faes', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: camille.faes@univ-lyon1.fr.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Saruco', 'Affiliation': 'Neurologische Universitätsklinik, Bergmannsheil gGmbH, Forschungsgruppe Plastizität, Bürkle-de-la-Camp-Platz 1, 44789 Bochum, Germany. Electronic address: elodie.saruco@ruhr-uni-bochum.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Collet', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: christian.collet@univ-lyon1.fr.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Di Rienzo', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: franck.di-rienzo@univ-lyon1.fr.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Debarnot', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: ursula.debarnot@univ-lyon1.fr.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.04.011']
360,32304734,Cetirizine inhibits gender-specific blood cell dynamics upon allergen contact in allergic rhinitis.,"IgE-mediated inflammatory responses upon allergen contact in allergic rhinitis (AR) are associated with rapid alterations of circulating blood cell numbers detectable in a complete blood count (CBC). Aim of this study was to evaluate whether intake of antihistamines may modulate allergen-induced CBC dynamics in male and female patients. A total of N = 112 specific allergen challenges were performed in otherwise healthy AR subjects. Seventy-two (n = 72) subjects received placebo and forty (n = 40) received cetirizine (H1-receptor antagonist) per os prior to allergen exposure in a randomized, double-blind trial at the Vienna Challenge Chamber (VCC); a subgroup of twenty-five (n = 25) subjects received cetirizine and placebo on different study days (parallel group). Blood samples and symptom scores were taken at baseline and immediately after 6 h of airway challenge simulating ambient allergen contact. Female sex was associated with a pronounced circulating monocyte increase (p < .01) and male sex with an eosinophil decrease (p < .05) in the placebo group, but not in cetirizine treated subjects. The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes. A more prominent thrombocyte increase in female subjects (p < .05) was noted upon allergen exposure, regardless of prior cetirizine intake. Cetirizine inhibited the mobilization of neutrophils, lymphocytes and decline in erythrocyte numbers, but did not affect thrombocyte increase upon allergen challenge. It further diminished gender-specific blood cell dynamics. Overall, as reflected in a simple CBC, cetirizine critically diminished immediate and late innate immune responses subsequent to allergen exposure.",2020,The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes.,"['allergic rhinitis', 'Seventy-two (n\u202f=\u202f72) subjects received', 'allergic rhinitis (AR', 'male and female patients', 'otherwise healthy AR subjects']","['cetirizine (H1-receptor antagonist) per os prior to allergen exposure', 'cetirizine and placebo', 'Cetirizine', 'antihistamines', 'placebo', 'cetirizine']","['circulating erythrocytes', 'segmented neutrophils', 'Blood samples and symptom scores', 'mobilization of neutrophils, lymphocytes and decline in erythrocyte numbers', 'circulating monocyte increase']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0055147', 'cui_str': 'Cetirizine'}, {'cui': 'C0034814', 'cui_str': 'Histamine H1 receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0229640', 'cui_str': 'Segmented neutrophil'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0553698', 'cui_str': 'Monocyte count increased'}]",72.0,0.125116,The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jordakieva', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria. Electronic address: galateja.jordakieva@meduniwien.ac.at.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': 'Center for Public Health, Department of Environmental Health, Medical University of Vienna, Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lemell', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jensen-Jarolim', 'Affiliation': 'Institute of Pathophysiology and Allergy Research, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Austria; The Interuniversity Messerli Research Institute, Medical University Vienna, University of Veterinary Medicine Vienna, University of Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Crevenna', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria.'}]","Clinical immunology (Orlando, Fla.)",['10.1016/j.clim.2020.108422']
361,31217579,Management of primary pterygium with intra-lesional injection of 5 flurouracil and bevacizumab (Avastin).,"BACKGROUND


To assess the efficacy of combined 5FU and Avastin injections in the treatment of primary pterygium METHODS: Sixteen eyes with primary pterygium received intralesional 5 fluorouracil and Avastin (2.5-5 mg) injections every 2 weeks for a maximum of five injections. Fourteen eyes of 14 patients received five injections, one eye received three injections and one eye received two injections. All eyes were followed at monthly intervals for 3 months after last injection. Tissue was obtained by surgical excision of primary pterygium from four eyes who received injections and three eyes with primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I.
RESULTS


Pterygium progression was arrested in all patients. Sixty-two percent of patients had improvement of redness while 89% had reduced thickness of the lesion. VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
CONCLUSIONS


The injection of 5 fluorouracil and Avastin act synergistically to arrest progression and induce atrophy in primary pterygium. This is related to the effect of agents on fibroblasts, collagen, and vascular tissues. Such medical intervention is a safe and viable option in the management of primary pterygium though excision of residual tissue is still required in some cases. Longer follow up is needed to ascertain whether this will reduce the recurrence rate following excision.",2019,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","['primary pterygium', 'Fourteen eyes of 14 patients', 'primary pterygium with intra-lesional injection of 5', 'Sixteen eyes with primary pterygium']","['combined 5FU and Avastin injections', 'intralesional 5 fluorouracil and Avastin', 'primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF', 'fluorouracil and Avastin', 'flurouracil and bevacizumab (Avastin']","['Pterygium progression', 'vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I', 'redness', 'VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I', 'recurrence rate']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}, {'cui': 'C0243982', 'cui_str': 'Hyaluronan Receptors'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.0193891,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","[{'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Ghoz', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Ross', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Mohammed', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hogan', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Dalia G', 'Initials': 'DG', 'LastName': 'Said', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Harminder S', 'Initials': 'HS', 'LastName': 'Dua', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK. harminder.dua@nottingham.ac.uk.'}]","Eye (London, England)",['10.1038/s41433-019-0493-0']
362,32325162,Effects of an Individualized Comprehensive Rehabilitation Program on Impaired Postural Control in Women With Chronic Pelvic Pain: A Randomized Controlled Trial.,"OBJECTIVE


To assess the effectiveness of an individualized comprehensive rehabilitation program (ICPR) on impaired postural control, pain, self-perceived health status, and functionality in women with chronic pelvic pain.
DESIGN


Randomized controlled trial.
SETTING


Women with chronic pelvic pain were recruited from the Gynecology Department of the University Hospital San Cecilio in Granada, Spain.
PARTICIPANTS


Participants (N=38) who were randomly divided into 2 groups.
INTERVENTIONS


The intervention group received an 8-week ICRP, and the control group received a leaflet with ergonomic information.
MAIN OUTCOME MEASURES


The main outcomes included were postural control (Mini Balance Evaluation Systems [Mini BESTest] and timed Up and Go [TUG]), pain (Brief Pain Inventory), self-perceived health status (EuroQol 5 dimensions [EQ-5D]), and functionality (Oswestry Disability Index [ODI]).
RESULTS


Significant differences were found between groups in the Mini BESTest and TUG scores with large effect sizes. The Brief Pain Inventory, EQ-5D, and ODI also presented significant differences in the between-groups analysis, with better scores in the intervention group after treatment. In the follow-up analysis, significant differences were found between groups in the Mini BESTest (P<.001), the cognitive TUG subscale (P=.032), interference of pain (P<.001), anxiety and depression (P=.001), and visual analog scale EQ-5D (P=.026) subscales, as well as the ODI (P<.001).
CONCLUSIONS


Our results show significant improvements on postural control, pain, self-perceived health status, and functionality in women with chronic pelvic pain who received an 8-week ICRP.",2020,"Our results show significant improvements on postural control, pain, self-perceived health status and functionality in women with CPP that received an eight-week ICRP.","['Women with chronic pelvic pain were recruited from the Gynaecology Department of the ""Hospital San Cecilio"" in Granada', '38 participants were included in the study and randomly divided into two groups', 'women with CPP', 'women with chronic pelvic pain']","['Individualized Comprehensive Rehabilitation Program', 'eight-week ICRP and the control group received a leaflet with ergonomic information', 'Individualized Comprehensive Rehabilitation Program (ICPR']","['Mini BESTest and TUG scores', 'VAS EQ-5D', 'interference of pain (p<0.001), anxiety/depression', 'postural control (Mini Balance Evaluation Systems, Mini BESTest and Timed Up and Go Test, TUG), pain (Brief Pain Inventory, BPI), self-perceived health status (Euroqol-5dimensions, EQ-5D) and functionality (Oswestry Disability Index, ODI', 'postural control', 'BPI, EQ-5D and ODI', 'cognitive TUG subscale', 'postural control, pain, self-perceived health status and functionality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0587481', 'cui_str': 'Gynecology department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",38.0,0.0673424,"Our results show significant improvements on postural control, pain, self-perceived health status and functionality in women with CPP that received an eight-week ICRP.","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Rodríguez-Torres', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-López', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cabrera-Martos', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Prados-Román', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Granados-Santiago', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Valenza', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain. Electronic address: cvalenza@ugr.es.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.019']
363,32326228,"Acute Effects of High-Definition Transcranial Direct Current Stimulation on Foot Muscle Strength, Passive Ankle Kinesthesia, and Static Balance: A Pilot Study.","This study aimed to examine the effects of single-session anodal high-definition transcranial direct current stimulation (HD-tDCS) on the strength of intrinsic foot muscles, passive ankle kinesthesia, and static balance.
METHODS


In this double-blinded self-controlled study, 14 healthy younger adults were asked to complete assessments of foot muscle strength, passive ankle kinesthesia, and static balance before and after a 20-minute session of either HD-tDCS or sham stimulation (i.e., control) at two visits separated by one week. Two-way repeated-measures analysis of variance was used to examine the effects of HD-tDCS on metatarsophalangeal joint flexor strength, toe flexor strength, the passive kinesthesia threshold of ankle joint, and the average sway velocity of the center of gravity.
RESULTS


All participants completed all study procedures and no side effects nor risk events were reported. Blinding was shown to be successful, with an overall accuracy of 35.7% in the guess of stimulation type (p = 0.347). No main effects of intervention, time, or their interaction were observed for foot muscle strength ( p  > 0.05). The average percent change in first-toe flexor strength following anodal HD-tDCS was 12.8 ± 24.2%, with 11 out of 14 participants showing an increase in strength, while the change following sham stimulation was 0.7 ± 17.3%, with 8 out of 14 participants showing an increase in strength. A main effect of time on the passive kinesthesia threshold of ankle inversion, dorsiflexion, and anteroposterior and medial-lateral average sway velocity of the center of gravity in one-leg standing with eyes closed was observed; these outcomes were reduced from pre to post stimulation (p < 0.05). No significant differences were observed for other variables between the two stimulation types.
CONCLUSION


The results of this pilot study suggested that single-session HD-tDCS may improve the flexor strength of the first toe, although no statistically significant differences were observed between the anodal HD-tDCS and sham procedure groups. Additionally, passive ankle kinesthesia and static standing balance performance were improved from pre to post stimulation, but no significant differences were observed between the HD-tDCS and sham procedure groups. This may be potentially due to ceiling effects in this healthy cohort of a small sample size. Nevertheless, these preliminary findings may provide critical knowledge of optimal stimulation parameters, effect size, and power estimation of HD-tDCS for future trials aiming to confirm and expand the findings of this pilot study.",2020,"No main effects of intervention, time, or their interaction were observed for foot muscle strength ( p  > 0.05).",['14 healthy younger adults'],"['single-session anodal high-definition transcranial direct current stimulation (HD-tDCS', 'HD-tDCS or sham stimulation', 'HD-tDCS', 'High-Definition Transcranial Direct Current Stimulation']","['metatarsophalangeal joint flexor strength, toe flexor strength', 'passive kinesthesia threshold of ankle inversion, dorsiflexion, and anteroposterior and medial-lateral average sway velocity of the center of gravity', 'flexor strength', 'passive ankle kinesthesia and static standing balance performance', 'foot muscle strength', 'Foot Muscle Strength, Passive Ankle Kinesthesia, and Static Balance', 'strength']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0025589', 'cui_str': 'Metatarsophalangeal joint structure'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0022701', 'cui_str': 'Sense of position and movement, function'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}]",14.0,0.0502868,"No main effects of intervention, time, or their interaction were observed for foot muscle strength ( p  > 0.05).","[{'ForeName': 'Songlin', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Baofeng', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Xini', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA 02131, USA.'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai 200438, China.'}]",Brain sciences,['10.3390/brainsci10040246']
364,32326236,Transcranial Direct Current Stimulation at 4 mA Induces Greater Leg Muscle Fatigability in Women Compared to Men.,"Transcranial direct current stimulation (tDCS) has previously shown different cortical excitability and neuropsychological effects between women and men. However, the sex-specific effects of tDCS on leg muscle fatigability has not been investigated. The purpose of this study was to determine the effects of a single session of 2 mA and 4 mA primary motor cortex tDCS on leg muscle fatigability in healthy young men and women in a crossover design. Twenty participants (women = 10) completed isokinetic fatigue testing (40 maximal reps, 120°/s) of the knee extensors and flexors in conjunction with sham, 2 mA, and 4 mA tDCS in a double-blind, randomized design. The fatigue index from each condition was calculated. Women had significantly greater knee extensor fatigability in the 4 mA condition compared to men (57.8 ± 6.8% versus 44.1 ± 18.4%;  p  = 0.041,  d  = 0.99). This study provides additional evidence that responses to tDCS may be sex-specific and highlights the necessity of accounting and powering for sex differences in future investigations.",2020,"Women had significantly greater knee extensor fatigability in the 4 mA condition compared to men (57.8 ± 6.8% versus 44.1 ± 18.4%;  p  = 0.041,  d  = 0.99).","['women and men', 'Women Compared to Men', 'Twenty participants (women = 10) completed', 'healthy young men and women in a crossover design']","['tDCS', 'single session of 2 mA and 4 mA primary motor cortex tDCS', 'Transcranial Direct Current Stimulation at 4 mA', 'isokinetic fatigue testing (40 maximal reps, 120°/s) of the knee extensors and flexors in conjunction with sham, 2 mA, and 4 mA tDCS', 'Transcranial direct current stimulation (tDCS']","['fatigue index', 'leg muscle fatigability', 'knee extensor fatigability', 'Leg Muscle Fatigability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",20.0,0.173461,"Women had significantly greater knee extensor fatigability in the 4 mA condition compared to men (57.8 ± 6.8% versus 44.1 ± 18.4%;  p  = 0.041,  d  = 0.99).","[{'ForeName': 'Craig D', 'Initials': 'CD', 'LastName': 'Workman', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Fietsam', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Rudroff', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, IA 52242, USA.'}]",Brain sciences,['10.3390/brainsci10040244']
365,32326304,A Pilot Randomised Clinical Trial of a Novel Approach to Reduce Sedentary Behaviour in Care Home Residents: Feasibility and Preliminary Effects of the GET READY Study.,"Care-home residents are among the most sedentary and least active of the population. We aimed to assess the feasibility, acceptability, safety, and preliminary effects of an intervention to reduce sedentary behaviour (SB) co-created with care home residents, staff, family members, and policymakers within a pilot two-armed pragmatic cluster randomized clinical trial (RCT). Four care homes from two European countries participated, and were randomly assigned to control (usual care, CG) or the Get Ready intervention (GR), delivered by a staff champion one-to-one with the care home resident and a family member. A total of thirty-one residents participated (51.6% female, 82.9 (13.6) years old). GR involves six face to face sessions over a 12-week period with goal-oriented prompts for movement throughout. The feasibility and acceptability of the intervention were assessed and adverse events (AEs) were collected. The preliminary effects of the GR on SB, quality of life, fear of falling, and physical function were assessed. Means and standard deviations are presented, with the mean change from baseline to post-intervention calculated along with 95% confidence intervals. The CG smoked more, sat more, and had more functional movement difficulties than the GR at baseline. The GR intervention was feasible and acceptable to residents and staff. No AEs occurred during the intervention. GR participants showed a decrease in daily hours spent sitting/lying (Cohen's d = 0.36) and an increase in daily hours stepping, and improvements in health-related quality of life, fear of falling, and habitual gait speed compared to usual care, but these effects need confirmation in a definitive RCT. The co-created GR was shown to be feasible and acceptable, with no AEs.",2020,"GR participants showed a decrease in daily hours spent sitting/lying (Cohen's d = 0.36) and an increase in daily hours stepping, and improvements in health-related quality of life, fear of falling, and habitual gait speed compared to usual care, but these effects need confirmation in a definitive RCT.","['Sedentary Behaviour in Care Home Residents', 'Four care homes from two European countries participated', 'A total of thirty-one residents participated (51.6% female, 82.9 (13.6) years old']","['control (usual care, CG) or the Get Ready intervention (GR), delivered by a staff champion one-to-one with the care home resident and a family member', 'GR intervention']","['sedentary behaviour (SB', 'daily hours spent sitting/lying', 'feasibility, acceptability, safety', 'SB, quality of life, fear of falling, and physical function', 'functional movement difficulties', 'daily hours stepping, and improvements in health-related quality of life, fear of falling, and habitual gait speed']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",31.0,0.0546158,"GR participants showed a decrease in daily hours spent sitting/lying (Cohen's d = 0.36) and an increase in daily hours stepping, and improvements in health-related quality of life, fear of falling, and habitual gait speed compared to usual care, but these effects need confirmation in a definitive RCT.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Giné-Garriga', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA, UK.'}, {'ForeName': 'Philippa M', 'Initials': 'PM', 'LastName': 'Dall', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA, UK.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Sandlund', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Umeå University, 901 87 Umeå, Sweden.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Jerez-Roig', 'Affiliation': 'Research Group on Methodology, Methods, Models and Outcome of Health and Social Sciences (M3O), Faculty of Health Sciences and Welfare, University of Vic-Central University of Catalonia (UVIC-UCC), 08500 Vic, Spain.'}, {'ForeName': 'Sebastien F M', 'Initials': 'SFM', 'LastName': 'Chastin', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA, UK.'}, {'ForeName': 'Dawn A', 'Initials': 'DA', 'LastName': 'Skelton', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17082866']
366,32326305,The Role of Anti-Angiogenics in Pre-Treated Metastatic  BRAF -Mutant Colorectal Cancer: A Pooled Analysis.,"Background . FOLFOXIRI plus Bevacizumab is one of the most frequently used first-line treatments for patients with  BRAF -mutant colorectal cancer (CRC), while second-line treatment requires extensive further research. In this pooled analysis, we evaluate the impact of anti-angiogenics in patients with pre-treated  BRAF -mutant CRC.  Methods.  We monitored patients in randomized, controlled studies who had advanced CRC and were undergoing second-line chemotherapy in addition to utilizing Bevacizumab, Ramucirumab or Aflibercept treatments. These data were pooled together with the data and results of  BRAF -mutant patients enrolled in two phase III trials (TRIBE and TRIBE-2 study), who had been treated with second-line treatment both with or without Bevacizumab. Overall survival (OS), in relation to  BRAF  mutational status, was the primary focus.  Results . Pooled analysis included 129 patients. Anti-angiogenics were found to have a significant advantage over the placebo in terms of OS (HR 0.50, 95%CI 0.29-0.85) ( p  = 0.01).  Conclusions . Our pooled analysis confirms the efficacy of anti-angiogenics in pre-treated  BRAF -mutant CRC, establishing the combination of chemotherapy plus Bevacizumab or Ramucirumab or Aflibercept as a valid treatment option.",2020,"Anti-angiogenics were found to have a significant advantage over the placebo in terms of OS (HR 0.50, 95%CI 0.29-0.85) ( p  = 0.01).  ","['patients with pre-treated  BRAF -mutant CRC', 'Colorectal Cancer', 'patients with  BRAF -mutant colorectal cancer (CRC', 'patients in randomized, controlled studies who had advanced CRC and were undergoing second-line chemotherapy in addition to utilizing', '129 patients']","['chemotherapy plus Bevacizumab or Ramucirumab or Aflibercept', 'Pre-Treated Metastatic  BRAF -Mutant', 'placebo', 'FOLFOXIRI plus Bevacizumab', 'Bevacizumab', 'Bevacizumab, Ramucirumab or Aflibercept treatments']",['Overall survival (OS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",129.0,0.0631283,"Anti-angiogenics were found to have a significant advantage over the placebo in terms of OS (HR 0.50, 95%CI 0.29-0.85) ( p  = 0.01).  ","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Gelsomino', 'Affiliation': 'Department of Oncology and Hematology, Division of Oncology, University of Modena and Reggio Emilia, 4121 Modena, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Casadei-Gardini', 'Affiliation': 'Department of Oncology and Hematology, Division of Oncology, University of Modena and Reggio Emilia, 4121 Modena, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rossini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, 56121 Pisa, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Boccaccino', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, 56121 Pisa, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Masi', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, 56121 Pisa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, 56121 Pisa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Spallanzani', 'Affiliation': 'Department of Oncology and Hematology, Division of Oncology, University of Modena and Reggio Emilia, 4121 Modena, Italy.'}, {'ForeName': 'Massimo Giuseppe', 'Initials': 'MG', 'LastName': 'Viola', 'Affiliation': 'Department of Surgery, Card. G. Panico Hospital of Tricase, 73039 Tricase, Italy.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Garajovà', 'Affiliation': 'Medical Oncology Unit, University Hospital of Parma, 43121 Parma, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Salati', 'Affiliation': 'Department of Oncology and Hematology, Division of Oncology, University of Modena and Reggio Emilia, 4121 Modena, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Elia', 'Affiliation': 'Department of Medical Oncology, Card. G. Panico Hospital of Tricase, 73039 Tricase, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Caputo', 'Affiliation': 'Department of Oncology and Hematology, Division of Oncology, University of Modena and Reggio Emilia, 4121 Modena, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Santini', 'Affiliation': 'Department of Oncology and Hematology, Division of Oncology, University of Modena and Reggio Emilia, 4121 Modena, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine, Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, 56121 Pisa, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cascinu', 'Affiliation': 'Department of Medical Oncology, Università Vita-Salute, San Raffaele Hospital IRCCS, 20019 Milan, Italy.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Tamburini', 'Affiliation': 'Department of Medical Oncology, Card. G. Panico Hospital of Tricase, 73039 Tricase, Italy.'}]",Cancers,['10.3390/cancers12041022']
367,32203691,"Efficacy of levetiracetam, fosphenytoin, and valproate for established status epilepticus by age group (ESETT): a double-blind, responsive-adaptive, randomised controlled trial.","BACKGROUND


Benzodiazepine-refractory, or established, status epilepticus is thought to be of similar pathophysiology in children and adults, but differences in underlying aetiology and pharmacodynamics might differentially affect response to therapy. In the Established Status Epilepticus Treatment Trial (ESETT) we compared the efficacy and safety of levetiracetam, fosphenytoin, and valproate in established status epilepticus, and here we describe our results after extending enrolment in children to compare outcomes in three age groups.
METHODS


In this multicentre, double-blind, response-adaptive, randomised controlled trial, we recruited patients from 58 hospital emergency departments across the USA. Patients were eligible for inclusion if they were aged 2 years or older, had been treated for a generalised convulsive seizure of longer than 5 min duration with adequate doses of benzodiazepines, and continued to have persistent or recurrent convulsions in the emergency department for at least 5 min and no more than 30 min after the last dose of benzodiazepine. Patients were randomly assigned in a response-adaptive manner, using Bayesian methods and stratified by age group (<18 years, 18-65 years, and >65 years), to levetiracetam, fosphenytoin, or valproate. All patients, investigators, study staff, and pharmacists were masked to treatment allocation. The primary outcome was absence of clinically apparent seizures with improved consciousness and without additional antiseizure medication at 1 h from start of drug infusion. The primary safety outcome was life-threatening hypotension or cardiac arrhythmia. The efficacy and safety outcomes were analysed by intention to treat. This study is registered in ClinicalTrials.gov, NCT01960075.
FINDINGS


Between Nov 3, 2015, and Dec 29, 2018, we enrolled 478 patients and 462 unique patients were included: 225 children (aged <18 years), 186 adults (18-65 years), and 51 older adults (>65 years). 175 (38%) patients were randomly assigned to levetiracetam, 142 (31%) to fosphenyltoin, and 145 (31%) were to valproate. Baseline characteristics were balanced across treatments within age groups. The primary efficacy outcome was met in those treated with levetiracetam for 52% (95% credible interval 41-62) of children, 44% (33-55) of adults, and 37% (19-59) of older adults; with fosphenytoin in 49% (38-61) of children, 46% (34-59) of adults, and 35% (17-59) of older adults; and with valproate in 52% (41-63) of children, 46% (34-58) of adults, and 47% (25-70) of older adults. No differences were detected in efficacy or primary safety outcome by drug within each age group. With the exception of endotracheal intubation in children, secondary safety outcomes did not significantly differ by drug within each age group.
INTERPRETATION


Children, adults, and older adults with established status epilepticus respond similarly to levetiracetam, fosphenytoin, and valproate, with treatment success in approximately half of patients. Any of the three drugs can be considered as a potential first-choice, second-line drug for benzodiazepine-refractory status epilepticus.
FUNDING


National Institute of Neurological Disorders and Stroke, National Institutes of Health.",2020,The primary outcome was absence of clinically apparent seizures with improved consciousness and without additional antiseizure medication at 1 h from start of drug infusion.,"['for 52% (95% credible interval 41-62) of children, 44% (33-55) of adults, and 37% (19-59) of older adults; with fosphenytoin in 49% (38-61) of children, 46% (34-59) of adults, and 35% (17-59) of older adults; and with valproate in 52% (41-63) of children, 46% (34-58) of adults, and 47% (25-70) of older adults', 'recruited patients from 58 hospital emergency departments across the USA', 'Children, adults, and older adults with established status epilepticus respond similarly to', 'Between Nov 3, 2015, and Dec 29, 2018, we enrolled 478 patients and 462 unique patients were included: 225 children (aged <18 years), 186 adults (18-65 years), and 51 older adults (>65 years', 'Patients were eligible for inclusion if they were aged 2 years or older, had been treated for a generalised convulsive seizure of longer than 5 min duration with adequate doses of benzodiazepines, and continued to have persistent or recurrent convulsions in the emergency department for at least 5 min and no more than 30 min after the last dose of']","['levetiracetam', 'levetiracetam, fosphenytoin, or valproate', 'levetiracetam, fosphenytoin, and valproate', 'benzodiazepine', 'valproate']","['efficacy and safety', 'life-threatening hypotension or cardiac arrhythmia', 'absence of clinically apparent seizures with improved consciousness and without additional antiseizure medication', 'efficacy and safety outcomes']","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0244656', 'cui_str': 'fosphenytoin'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0038220', 'cui_str': 'Status Epilepticus, Generalized'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0751494', 'cui_str': 'Convulsive Seizures'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1869075', 'cui_str': 'Convulsions (SMQ)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0244656', 'cui_str': 'fosphenytoin'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C1869051', 'cui_str': 'Cardiac arrhythmias (SMQ)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]",478.0,0.634583,The primary outcome was absence of clinically apparent seizures with improved consciousness and without additional antiseizure medication at 1 h from start of drug infusion.,"[{'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Chamberlain', 'Affiliation': ""Division of Emergency Medicine Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Kapur', 'Affiliation': 'Department of Neurology, University of Virginia Health Sciences Center, Charlottesville, VA, USA.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Shinnar', 'Affiliation': 'Neurology, Pediatrics and Epidemiology and Population Health Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Elm', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Holsti', 'Affiliation': 'Division of Pediatric Emergency Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Babcock', 'Affiliation': ""Division of Pediatric Emergency Medicine, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA; Department of Pediatrics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Barsan', 'Affiliation': 'Department of Emergency Medicine, Neuro Emergencies Research, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cloyd', 'Affiliation': 'Center for Orphan Drug Research, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lowenstein', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Bleck', 'Affiliation': 'Division of Stroke and Neurocritical Care, Northwestern University Feinberg School of Medicine, Chicago, IL USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health Neuroscience Center, Bethesda, MD, USA.'}, {'ForeName': 'Caitlyn', 'Initials': 'C', 'LastName': 'Meinzer', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Cock', 'Affiliation': ""Institute of Molecular and Clinical Sciences, St George's University of London, London, UK.""}, {'ForeName': 'Nathan B', 'Initials': 'NB', 'LastName': 'Fountain', 'Affiliation': 'Department of Neurology, University of Virginia Health Sciences Center, Charlottesville, VA, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Underwood', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Connor', 'Affiliation': 'ConfluenceStat LLC and University of Central Florida College of Medicine, Cooper City, FL, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': 'Department of Emergency Medicine, Neuro Emergencies Research, University of Michigan, Ann Arbor, MI, USA. Electronic address: robert.silbergleit@umich.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30611-5']
368,31927499,Brain age prediction in stroke patients: Highly reliable but limited sensitivity to cognitive performance and response to cognitive training.,"Cognitive deficits are important predictors for outcome, independence and quality of life after stroke, but often remain unnoticed and unattended because other impairments are more evident. Computerized cognitive training (CCT) is among the candidate interventions that may alleviate cognitive difficulties, but the evidence supporting its feasibility and effectiveness is scarce, partly due to the lack of tools for outcome prediction and monitoring. Magnetic resonance imaging (MRI) provides candidate markers for disease monitoring and outcome prediction. By integrating information not only about lesion extent and localization, but also regarding the integrity of the unaffected parts of the brain, advanced MRI provides relevant information for developing better prediction models in order to tailor cognitive intervention for patients, especially in a chronic phase. Using brain age prediction based on MRI based brain morphometry and machine learning, we tested the hypotheses that stroke patients with a younger-appearing brain relative to their chronological age perform better on cognitive tests and benefit more from cognitive training compared to patients with an older-appearing brain. In this randomized double-blind study, 54 patients who suffered mild stroke (>6 months since hospital admission, NIHSS≤7 at hospital discharge) underwent 3-weeks CCT and MRI before and after the intervention. In addition, patients were randomized to one of two groups receiving either active or sham transcranial direct current stimulation (tDCS). We tested for main effects of brain age gap (estimated age - chronological age) on cognitive performance, and associations between brain age gap and task improvement. Finally, we tested if longitudinal changes in brain age gap during the intervention were sensitive to treatment response. Briefly, our results suggest that longitudinal brain age prediction based on automated brain morphometry is feasible and reliable in stroke patients. However, no significant association between brain age and both performance and response to cognitive training were found.",2020,"However, no significant association between brain age and both performance and response to cognitive training were found.","['patients with an older-appearing brain', '54 patients who suffered mild stroke (>6 months since hospital admission, NIHSS≤7 at hospital discharge) underwent 3-weeks CCT and MRI before and after the intervention', 'stroke patients with a younger-appearing brain relative to their chronological age', 'stroke patients']","['Computerized cognitive training (CCT', 'Magnetic resonance imaging (MRI', 'active or sham transcranial direct current stimulation (tDCS', 'cognitive training']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]",[],54.0,0.0501623,"However, no significant association between brain age and both performance and response to cognitive training were found.","[{'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Richard', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Norway; Department of Psychology, University of Oslo, Norway; Sunnaas Rehabilitation Hospital HT, Nesodden, Norway. Electronic address: genevieve.richard@medisin.uio.no.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Kolskår', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Norway; Department of Psychology, University of Oslo, Norway; Sunnaas Rehabilitation Hospital HT, Nesodden, Norway.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Ulrichsen', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Norway; Department of Psychology, University of Oslo, Norway; Sunnaas Rehabilitation Hospital HT, Nesodden, Norway.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kaufmann', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Alnæs', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Anne-Marthe', 'Initials': 'AM', 'LastName': 'Sanders', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Norway; Department of Psychology, University of Oslo, Norway; Sunnaas Rehabilitation Hospital HT, Nesodden, Norway.'}, {'ForeName': 'Erlend S', 'Initials': 'ES', 'LastName': 'Dørum', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Norway; Department of Psychology, University of Oslo, Norway; Sunnaas Rehabilitation Hospital HT, Nesodden, Norway.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Monereo Sánchez', 'Affiliation': 'Faculty of Health, Medicine and Life Sciences, Maastricht University, Netherlands; Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Netherlands.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Petersen', 'Affiliation': 'Center for Visual Cognition, Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hege', 'Initials': 'H', 'LastName': 'Ihle-Hansen', 'Affiliation': 'Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jan Egil', 'Initials': 'JE', 'LastName': 'Nordvik', 'Affiliation': 'CatoSenteret Rehabilitation Center, Son, Norway.'}, {'ForeName': 'Lars T', 'Initials': 'LT', 'LastName': 'Westlye', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Norway; Department of Psychology, University of Oslo, Norway. Electronic address: l.t.westlye@psykologi.uio.no.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102159']
369,30707970,Soy isoflavones reduce asthma exacerbation in asthmatic patients with high PAI-1-producing genotypes.,"BACKGROUND


The 4G4G genotype of plasminogen activator inhibitor 1 (PAI-1) is associated with increased plasma PAI-1 levels and poor asthma control. Previous studies suggest that soy isoflavones can reduce PAI-1 levels.
OBJECTIVE


We sought to investigate PAI-1 genotype-specific differences of the soy isoflavone response in asthma outcomes.
METHODS


A PAI-1 functional polymorphism (rs1799768, 4G5G) was characterized in subjects with poorly controlled asthma enrolled in a randomized clinical trial of soy isoflavones (n = 265). Genotype-specific treatment responses on asthma outcomes were compared between soy isoflavones and placebo. Normal human bronchial epithelial cells were cultured with or without TGF-β1, genistein, or both, and PAI-1 levels were measured.
RESULTS


The 4G4G/4G5G genotype was associated with a greater risk for allergy-related worsened asthma symptoms and eczema at baseline compared with the 5G5G genotype. There was a significant interaction between the genotype and soy isoflavone intervention on oral corticosteroid use for asthma exacerbation (P = .005). In a subgroup analysis soy isoflavones significantly reduced the use of oral corticosteroids (number of events/person-year) by 4-fold compared with placebo in the 4G4G/4G5G genotype (0.2 vs 0.8; relative risk, 0.28; P < .001) but not in the 5G5G genotype. Soy isoflavones reduced plasma PAI-1 levels compared with placebo. Genistein treatment reduced TGF-β1-induced PAI-1 production in normal human bronchial epithelial cells.
CONCLUSIONS


This study demonstrates that soy isoflavone treatment provides a significant benefit in reducing the number of severe asthma exacerbations in asthmatic patients with the high PAI-1-producing genotype. PAI-1 polymorphisms can be used as a genetic biomarker for soy isoflavone-responsive patients with asthma.",2019,The 4G4G/4G5G genotype was associated with a greater risk for allergy-related worsened asthma symptoms and eczema at baseline compared with the 5G5G genotype.,"['responsive patients with asthma', 'normal human bronchial epithelial cells', 'A PAI-1 functional polymorphism (rs1799768, 4G5G) was characterized in subjects with poorly controlled asthma enrolled', 'asthmatic patients with high PAI-1-producing genotypes', 'asthmatic patients with the high PAI-1-producing genotype']","['placebo', 'Genistein', 'soy isoflavones and placebo', 'soy isoflavone', 'soy isoflavones', 'soy isoflavone intervention', 'Soy isoflavones']","['Normal human bronchial epithelial cells', 'plasma PAI-1 levels', 'number of severe asthma exacerbations', 'TGF-β1-induced PAI-1 production', 'oral corticosteroids']","[{'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205039', 'cui_str': 'Bronchial (qualifier value)'}, {'cui': 'C0014597', 'cui_str': 'Epithelial Cells'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061202', 'cui_str': 'Genistein'}, {'cui': 'C4076257', 'cui_str': 'Soy isoflavone (substance)'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205039', 'cui_str': 'Bronchial (qualifier value)'}, {'cui': 'C0014597', 'cui_str': 'Epithelial Cells'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]",,0.185136,The 4G4G/4G5G genotype was associated with a greater risk for allergy-related worsened asthma symptoms and eczema at baseline compared with the 5G5G genotype.,"[{'ForeName': 'Seong H', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Division of Allergy-Immunology, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, Fla; Division of Rheumatology, Department of Internal Medicine, School of Medicine, Kyung Hee University, Seoul, Korea. Electronic address: scho2@health.usf.edu.'}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Jo', 'Affiliation': 'Division of Allergy-Immunology, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, Fla.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Casale', 'Affiliation': 'Division of Allergy-Immunology, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, Fla.'}, {'ForeName': 'Su J', 'Initials': 'SJ', 'LastName': 'Jeong', 'Affiliation': 'Department of Statistics Support, Medical Science Research Institute, School of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Seung-Jae', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, School of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Joong K', 'Initials': 'JK', 'LastName': 'Cho', 'Affiliation': 'Division of Allergy-Immunology, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, Fla.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Division of Allergy-Immunology, Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, Ill.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Ill.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.01.020']
370,30711299,Conversation about the future self improves preschoolers' prospection abilities.,"Prospection, the ability to engage in future-oriented thinking and decision making, begins to develop during the preschool years yet remains far from adult-like. One specific challenge for children of this age is with regard to thinking and reasoning about their future selves. Drawing from work indicating the importance of adult-child conversation in language and cognitive development, the current study examined the extent to which conversations about the future and the self may facilitate preschool-aged children's prospective thinking. The participants, 4- and 5-year-old children (N = 68), were randomly assigned to read books surrounding one of four topics with an adult experimenter: their present self, their future self, another child's present self, or another child's future self. Children whose conversations were centered on their future selves outperformed other children in the sample on a battery of prospection assessments taken immediately after the manipulation. Of the three prospection assessments administered, the manipulation had the strongest effect on children's prospective memories. Results are discussed in terms of the role that everyday conversation can play in fostering children's cognitive development during the early childhood years.",2019,Children whose conversations were centered on their future selves outperformed other children in the sample on a battery of prospection assessments taken immediately after the manipulation.,"['participants, 4- and 5-year-old children (N\u202f=\u202f68']","[""read books surrounding one of four topics with an adult experimenter: their present self, their future self, another child's present self, or another child's future self""]",[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0006002', 'cui_str': 'Books'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],,0.0110998,Children whose conversations were centered on their future selves outperformed other children in the sample on a battery of prospection assessments taken immediately after the manipulation.,"[{'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Leech', 'Affiliation': 'Harvard University Graduate School of Education, Cambridge, MA 02138, USA. Electronic address: kathryn_leech@gse.harvard.edu.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Leimgruber', 'Affiliation': 'Department of Psychology, Franklin & Marshall College, Lancaster, PA 17604, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Warneken', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Rowe', 'Affiliation': 'Harvard University Graduate School of Education, Cambridge, MA 02138, USA.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2018.12.008']
371,31277991,"Feasibility, Acceptability, and Process Indicators for Guy2Guy, an mHealth HIV Prevention Program for Sexual Minority Adolescent Boys.","PURPOSE


Guy2Guy is one of the first mHealth HIV prevention programs for sexual minority boys aged 14-18 years, evaluated nationally. Here, we examine the program's feasibility and acceptability and explore participants' feedback about program content and components intended to invigorate program engagement.
METHODS


Guy2Guy was tested in a randomized controlled trial of 302 youth assigned to either the intervention or an attention-matched control group. At 3-month follow-up, participants completed a survey that included questions about feasibility and acceptability. Focus groups were conducted with a subset of intervention participants (n = 45) to further understand their program experience.
RESULTS


The protocol and program appeared to be feasible: 94% completed the 3-month follow-up survey. The intervention also appeared to be acceptable: 93% of intervention participants said they somewhat or strongly agreed that they liked the program. Although ∼20% boys agreed that the program sent too many messages, only 10% said they stopped reading the messages by the end. Focus group participants were largely enthusiastic about program content and generally appreciated receiving information and skills-building messages that talked about HIV risk reduction. Some indicated a desire for more content that addressed condom negotiation. Program engagement components, particularly the weekly ""level up"" quiz, also were generally well received.
CONCLUSIONS


Sexual minority boys are willing to engage in Guy2Guy, an intensive, multiweek sexual health intervention via text messaging, and most would recommend the program to their friends.",2019,The intervention also appeared to be acceptable: 93% of intervention participants said they somewhat or strongly agreed that they liked the program.,"['Sexual Minority Adolescent Boys', 'sexual minority boys aged 14-18\xa0years, evaluated nationally', '302 youth assigned to either the']",['intervention or an attention-matched control group'],[],"[{'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],302.0,0.0217854,The intervention also appeared to be acceptable: 93% of intervention participants said they somewhat or strongly agreed that they liked the program.,"[{'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Ybarra', 'Affiliation': 'Center for Innovative Public Health Research, San Clemente, California. Electronic address: Michele@innovativePublicHealth.org.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Prescott', 'Affiliation': 'Center for Innovative Public Health Research, San Clemente, California.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mustanski', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing and Department of Medical Social Sciences, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Parsons', 'Affiliation': 'Department of Psychology, Hunter College, City University of New York, New York, New York.'}, {'ForeName': 'Sheana S', 'Initials': 'SS', 'LastName': 'Bull', 'Affiliation': 'Community and Behavioral Health, Colorado School of Public Health, Denver, Colorado.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.04.025']
372,32325958,Modifications to Infant Formula Instructions Improve the Accuracy of Formula Dispensing.,"Readability of infant formula preparation instructions is universally poor, which may result in inaccurate infant feeding. Given that inaccurate formula dispensing can lead to altered infant growth and increased adiposity, there is an increased need for easy to follow instructions for formula preparation. We hypothesize that altering infant formula instruction labels using feedback from iterative focus groups will improve the preparation accuracy of powdered infant formula in a randomized controlled trial. Participants were recruited from the community, 18 years of age or older, willing to disclose demographic information for focus group matching, and willing to participate freely in the first ( n  = 21) or second ( n  = 150) phase of the study. In the second phase, participants were randomized to use the standard manufacturer instructions or to use the modified instructions created in the first phase. Accuracy was defined as the percent error between manufacturer-intended powder formula quantity and the amount dispensed by the participant. Participants who were assigned to the modified instructions were able to dispense the powdered formula more accurately than participants who used the standard manufacturer instructions (-0.67 ± 0.76 vs. -4.66 ± 0.74% error;  p  < 0.0001). Accuracy in powdered formula dispensing was influenced by bottle size ( p  = 0.02) but not by body mass index ( p  = 0.17), education level ( p  = 0.75), income ( p  = 0.7), age ( p  = 0.89) or caregiver status ( p  = 0.18). Percent error of water measurement was not different between the groups (standard: -1.4 ± 0.6 vs. modified: 0.7 ± 0.6%;  p  = 0.38). Thus, caloric density was more accurate in the modified instructions group compared to the standard manufacturer instructions group (-0.3 ± 0.6 vs.-2.9 ± 0.9%;  p  = 0.03). Infant formula label modifications using focus group feedback increased infant formula preparation accuracy.",2020,Participants who were assigned to the modified instructions were able to dispense the powdered formula more accurately than participants who used the standard manufacturer instructions (-0.67 ± 0.76 vs. -4.66 ± 0.74% error;  p  < 0.0001).,"['Participants were recruited from the community, 18 years of age or older, willing to disclose demographic information for focus group matching, and willing to participate freely in the first ( n  = 21) or second ( n  = 150) phase of the study']",[],"['education level', 'Percent error of water measurement', 'caloric density']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",,0.057273,Participants who were assigned to the modified instructions were able to dispense the powdered formula more accurately than participants who used the standard manufacturer instructions (-0.67 ± 0.76 vs. -4.66 ± 0.74% error;  p  < 0.0001).,"[{'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Gilmore', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Abby D', 'Initials': 'AD', 'LastName': 'Altazan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Emily W', 'Initials': 'EW', 'LastName': 'Flanagan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Alexandra G', 'Initials': 'AG', 'LastName': 'Beyer', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Kelsey N', 'Initials': 'KN', 'LastName': 'Olson', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Alexis A', 'Initials': 'AA', 'LastName': ""O'Connell"", 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Nguyen', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}]",Nutrients,['10.3390/nu12041150']
373,32326047,Reduction in the Choking Phenomenon in Elite Diving Athletes Through Changes in Gut Microbiota Induced by Yogurt Containing  Bifidobacterium animalis  subsp.  lactis  BB-12: A Quasi Experimental Study.,"OBJECTIVE


The aims of this study are as follows: (1) to understand the relationship between gut microbiota and the choking phenomenon in diving athletes, and (2) to regulate the gut microbiota in diving athletes by drinking yogurt containing Bifidobacterium animalis subsp. lactis BB-12 and observe changes in the choking phenomenon in diving athletes.
METHODS


Experiment 1: A total of 20 diving athletes were tested in low- and high-pressure situations. Gut microbiota (n = 18) composition was then determined and differences in the gut microbiota composition among diving athletes who presented choking vs. no choking were identified. Experiment 2: A total of 16 divers who presented choking were divided into a high yogurt group (n = 6) and a low yogurt group (n = 10) for 15 days.
RESULTS


(1) The content of Veillonellaceae in divers who presented choking was significantly higher when compared to divers who did not present choking ( p  < 0.05). Bifidobacteriaceae ( r  = -0.52,  p  < 0.05) and Lactobacillaceae ( r  = -0.66,  p  < 0.05) were negatively correlated with the choking index. (2) During experiment 2, the average daily intake of the high yogurt group was 611.78 ± 94.94 mL and the average daily intake of the low yogurt group was 338 ± 71.45 mL and the abundance of Bifidobacteriaceae was significantly higher in the high yogurt group than in the low yogurt group. After the experiment, the choking index in the high yogurt group became significantly lower than that of the low yogurt group ( z  = -3.26,  p  < 0.001).
CONCLUSION


The intake of yogurt containing B. animalis subsp. lactis can increase the abundance of Bifidobacteriaceae in elite diving athletes and their performance under high pressure. Hence, gut microbiota may affect the choking phenomenon in elite diving athletes.",2020,(1) The content of Veillonellaceae in divers who presented choking was significantly higher when compared to divers who did not present choking ( p  < 0.05).,"['diving athletes by drinking yogurt containing Bifidobacterium animalis subsp', 'elite diving athletes', 'Experiment 1', '20 diving athletes', 'Elite Diving Athletes', 'A total of 16 divers who presented choking']",[],"['content of Veillonellaceae in divers who presented choking', 'choking index', 'abundance of Bifidobacteriaceae', 'average daily intake', 'Bifidobacteriaceae', 'Lactobacillaceae', 'gut microbiota composition']","[{'cui': 'C0012823', 'cui_str': 'Diving'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0452819', 'cui_str': 'Drinking yogurt'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0403082', 'cui_str': 'Diver'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008301', 'cui_str': 'Choking'}]",[],"[{'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0042447', 'cui_str': 'Acidaminococcaceae'}, {'cui': 'C0403082', 'cui_str': 'Diver'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008301', 'cui_str': 'Choking'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1003847', 'cui_str': 'Bifidobacteriaceae'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0022937', 'cui_str': 'Lactobacillaceae'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",20.0,0.0176118,(1) The content of Veillonellaceae in divers who presented choking was significantly higher when compared to divers who did not present choking ( p  < 0.05).,"[{'ForeName': 'Weizhong', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Research Centre For Exercise Detoxification, College of Physical Education, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Research Centre For Exercise Detoxification, College of Physical Education, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Shuaixiong', 'Initials': 'S', 'LastName': 'Liao', 'Affiliation': 'Research Centre For Exercise Detoxification, College of Physical Education, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Minghang', 'Initials': 'M', 'LastName': 'Lai', 'Affiliation': 'Research Centre For Exercise Detoxification, College of Physical Education, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Research Centre For Exercise Detoxification, College of Physical Education, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Song', 'Affiliation': 'Research Centre For Exercise Detoxification, College of Physical Education, Southwest University, Chongqing 400715, China.'}]",Microorganisms,['10.3390/microorganisms8040597']
374,32326082,"Mindfulness versus Physical Exercise: Effects of Two Recovery Strategies on Mental Health, Stress and Immunoglobulin A during Lunch Breaks. A Randomized Controlled Trial.","This research analyses the effects of mindfulness meditation (MM) and physical exercise (PE), practised as daily recovery activities during lunch breaks, on perceived stress, general mental health, and immunoglobin A (IgA). A three-armed randomized controlled trial with 94 employees was conducted for five weeks including two follow-up sessions after one and six months. Daily practice lasted 30 min maximum. Perceived stress and general mental health questionnaires and saliva samples were used. There were significant differences in time factor comparing pre- and post-test of Perceived Stress Questionnaire (PSQ) both for PE [Mdiff = 0.10, SE = 0.03,  p  = 0.03], and for MM [Mdiff = 0.09, SE = 0.03,  p  = 0.03]. Moreover, there were significant differences of interaction factor when comparing MM vs. PE in total score at pre-post [F = -2.62 (6, 168.84),  p  = 0.02, ω 2  = 0.09], favoring PE with medium and high effect sizes. Regarding General Health Questionnaire (GHQ) variable, practicing MM showed significant effects in time factor compared to pre-Fup2. No significant differences were found for IgA. Thus, practicing both MM and PE as recovery strategies during lunch breaks could reduce perceived stress after five weeks of practice, with better results for PE. Moreover, practicing MM could improve mental health with effects for 6 months.",2020,"There were significant differences in time factor comparing pre- and post-test of Perceived Stress Questionnaire (PSQ) both for PE [Mdiff = 0.10, SE = 0.03,  p  = 0.03], and for MM [Mdiff = 0.09, SE = 0.03,  p  = 0.03].",['94 employees'],"['Mindfulness versus Physical Exercise', 'mindfulness meditation (MM) and physical exercise (PE']","['mental health', 'Mental Health, Stress and Immunoglobulin A during Lunch Breaks', 'time factor comparing pre- and post-test of Perceived Stress Questionnaire (PSQ', 'perceived stress, general mental health, and immunoglobin A (IgA', 'Perceived stress and general mental health questionnaires and saliva samples']","[{'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0040225', 'cui_str': 'Time Factors'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",94.0,0.120693,"There were significant differences in time factor comparing pre- and post-test of Perceived Stress Questionnaire (PSQ) both for PE [Mdiff = 0.10, SE = 0.03,  p  = 0.03], and for MM [Mdiff = 0.09, SE = 0.03,  p  = 0.03].","[{'ForeName': 'Cintia', 'Initials': 'C', 'LastName': 'Díaz-Silveira', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, Universidad Rey Juan Carlos, Avda. Atenas s/n, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Carlos-María', 'Initials': 'CM', 'LastName': 'Alcover', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, Universidad Rey Juan Carlos, Avda. Atenas s/n, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Burgos', 'Affiliation': 'Faculty of Psychology, Universidad Nacional de Educación a Distancia, c/Juan del Rosal 10, 29040 Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Marcos', 'Affiliation': 'Faculty of Psychology, Universidad Nacional de Educación a Distancia, c/Juan del Rosal 10, 29040 Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Santed', 'Affiliation': 'Faculty of Psychology, Universidad Nacional de Educación a Distancia, c/Juan del Rosal 10, 29040 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17082839']
375,32326664,Ubiquinol Ameliorates Endothelial Dysfunction in Subjects with Mild-to-Moderate Dyslipidemia: A Randomized Clinical Trial.,"In this randomized, double-blind, single-center trial (ANZCTR number ACTRN12619000436178) we aimed to investigate changes in endothelium-dependent vasodilation induced by ubiquinol, the reduced form of coenzyme Q10 (CoQ10), in healthy subjects with moderate dyslipidemia. Fifty-one subjects with low-density lipoprotein (LDL) cholesterol levels of 130-200 mg/dL, not taking statins or other lipid lowering treatments, moderate (2.5%-6.0%) endothelial dysfunction as measured by flow-mediated dilation (FMD) of the brachial artery, and no clinical signs of cardiovascular disease were randomized to receive either ubiquinol (200 or 100 mg/day) or placebo for 8 weeks. The primary outcome measure was the effect of ubiquinol supplementation on FMD at the end of the study. Secondary outcomes included changes in FMD on week 4, changes in total and oxidized plasma CoQ10 on week 4 and week 8, and changes in serum nitrate and nitrite levels (NOx), and plasma LDL susceptibility to oxidation in vitro on week 8. Analysis of the data of the 48 participants who completed the study demonstrated a significantly increased FMD in both treated groups compared with the placebo group (200 mg/day, +1.28% ± 0.90%; 100 mg/day, +1.34% ± 1.44%;  p  < 0.001) and a marked increase in plasma CoQ10, either total ( p  < 0.001) and reduced ( p  < 0.001). Serum NOx increased significantly and dose-dependently in all treated subjects ( p  = 0.016), while LDL oxidation lag time improved significantly in those receiving 200 mg/day ( p  = 0.017). Ubiquinol significantly ameliorated dyslipidemia-related endothelial dysfunction. This effect was strongly related to increased nitric oxide bioavailability and was partly mediated by enhanced LDL antioxidant protection.",2020,"CoQ10, either total ( p  < 0.001) and reduced ( p  < 0.001).","['healthy subjects with moderate dyslipidemia', 'Subjects with Mild-to-Moderate Dyslipidemia', 'Fifty-one subjects with low-density lipoprotein (LDL) cholesterol levels of 130-200 mg/dL, not taking statins or other lipid lowering treatments, moderate (2.5%-6.0%) endothelial dysfunction as measured by flow-mediated dilation (FMD) of the brachial artery, and no clinical signs of cardiovascular disease']","['ubiquinol', 'placebo']","['plasma', 'effect of ubiquinol supplementation on FMD', 'LDL oxidation lag time', 'changes in FMD on week 4, changes in total and oxidized plasma CoQ10 on week 4 and week 8, and changes in serum nitrate and nitrite levels (NOx), and plasma LDL susceptibility to oxidation', 'Serum NOx', 'FMD', 'dyslipidemia-related endothelial dysfunction', 'nitric oxide bioavailability', 'Ubiquinol Ameliorates Endothelial Dysfunction']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0077656', 'cui_str': 'ubiquinol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0077656', 'cui_str': 'ubiquinol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0580333', 'cui_str': 'Urine nitrite'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",51.0,0.350858,"CoQ10, either total ( p  < 0.001) and reduced ( p  < 0.001).","[{'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Sabbatinelli', 'Affiliation': 'Department of Clinical and Molecular Sciences, Università Politecnica delle Marche, Via Tronto 10/A, 60126 Ancona, Italy.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Orlando', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Ranieri 65, 60128 Ancona, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Galeazzi', 'Affiliation': 'Clinical Laboratory and Molecular Diagnostics, IRCCS INRCA, Via della Montagnola 81, 60127 Ancona, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Silvestri', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Ranieri 65, 60128 Ancona, Italy.'}, {'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Cirilli', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Ranieri 65, 60128 Ancona, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Marcheggiani', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Ranieri 65, 60128 Ancona, Italy.'}, {'ForeName': 'Phiwayinkosi V', 'Initials': 'PV', 'LastName': 'Dludla', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Ranieri 65, 60128 Ancona, Italy.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Giuliani', 'Affiliation': 'Department of Clinical and Molecular Sciences, Università Politecnica delle Marche, Via Tronto 10/A, 60126 Ancona, Italy.'}, {'ForeName': 'Anna Rita', 'Initials': 'AR', 'LastName': 'Bonfigli', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Via della Montagnola 81, 60127 Ancona, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mazzanti', 'Affiliation': 'Department of Clinical Sciences, Biology and Biochemistry Section, Università Politecnica delle Marche, Via Ranieri 65, 60128 Ancona, Italy.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Olivieri', 'Affiliation': 'Department of Clinical and Molecular Sciences, Università Politecnica delle Marche, Via Tronto 10/A, 60126 Ancona, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Antonicelli', 'Affiliation': 'Cardiology Unit, IRCCS INRCA, Via della Montagnola 81, 60127 Ancona, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Tiano', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Ranieri 65, 60128 Ancona, Italy.'}]",Nutrients,['10.3390/nu12041098']
376,30858518,Lithium continuation therapy following ketamine in patients with treatment resistant unipolar depression: a randomized controlled trial.,"The N-methyl-D-aspartate (NMDA) receptor antagonist ketamine is associated with rapid but transient antidepressant effects in patients with treatment resistant unipolar depression (TRD). Based on work suggesting that ketamine and lithium may share overlapping mechanisms of action, we tested lithium compared to placebo as a continuation strategy following ketamine in subjects with TRD. Participants who met all eligibility criteria and showed at least an initial partial response to a single intravenous infusion of ketamine 0.5 mg/kg were randomized under double-blind conditions to lithium or matching placebo before receiving an additional three infusions of ketamine. Subsequent to the ketamine treatments, participants remained on lithium or placebo during a double-blind continuation phase. The primary study outcome was depression severity as measured by the Montgomery-Åsberg Depression Rating Scale compared between the two groups at Study Day 28, which occurred ~2 weeks following the final ketamine of four infusions. Forty-seven participants with TRD were enrolled in the study and underwent an initial ketamine infusion, of whom 34 participants were deemed to have at least a partial antidepressant response and were eligible for randomization. Comparison between treatment with daily oral lithium (n = 18) or matching placebo (n = 16) at the primary outcome showed no difference in depression severity between groups (t 32  = 0.11, p = 0.91, 95% CI [-7.87, 8.76]). There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine. The identification of a safe and effective strategy for preventing depression relapse following an acute course of ketamine treatment remains an important goal for future studies.",2019,There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine.,"['Participants who met all eligibility criteria and showed at least an initial partial response to a single intravenous infusion of ketamine 0.5\u2009mg/kg', 'subjects with TRD', 'patients with treatment resistant unipolar depression (TRD', 'patients with treatment resistant unipolar depression', 'Forty-seven participants with TRD were enrolled in the study and underwent an initial ketamine infusion, of whom 34 participants were deemed to have at least a partial antidepressant response and were eligible for randomization']","['ketamine', 'matching placebo', 'ketamine and lithium', 'placebo', 'lithium or placebo', 'daily oral lithium', 'N-methyl-D-aspartate (NMDA) receptor antagonist ketamine', 'Lithium continuation therapy', 'lithium and placebo', 'lithium or matching placebo']","['depression severity', 'depression severity as measured by the Montgomery-Åsberg Depression Rating Scale']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0041696', 'cui_str': 'Unipolar Depression'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4521484', 'cui_str': 'N-methyl-D-aspartate receptor antagonist (disposition)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",34.0,0.668127,There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Costi', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Laili', 'Initials': 'L', 'LastName': 'Soleimani', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Glasgow', 'Affiliation': 'Department of Anesthesiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Brallier', 'Affiliation': 'Department of Anesthesiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Spivack', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Cara F', 'Initials': 'CF', 'LastName': 'Levitch', 'Affiliation': 'Department of Psychology, Fordham University, Bronx, NY, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Richards', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hoch', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wade', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Welch', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Collins', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Feder', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Charney', 'Affiliation': 'Department of Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA. james.murrough@mssm.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0365-0']
377,32278106,Perineal repair of media-lateral episiotomies and 2nd degree tears by midwives: A randomised controlled trial comparing three suture techniques.,"BACKGROUND


Perineal trauma pain is associated with perineal repair and its subsequent healing. New evidence is required concerning perineal repair techniques that cause less pain and favour healing.
OBJECTIVE


To compare three perineal repair suturing techniques after episiotomy or second degree tearing during a normal birth with respect to reducing pain and improving the perineal healing process.
DESIGN


A randomised controlled trial.
SETTING


A large public university hospital in Madrid, Spain.
PARTICIPANTS


Full term pregnant women older than 18 years-of-age, who required perineal repair after episiotomy or second degree tearing and were attended for normal birth by midwives.
METHODS


One hundred and eighty-three women were randomly assigned to three groups: the Continuous Suture Group (n = 58), Interrupted Cutaneous Suture Group (n = 53), or the Interrupted Subcutaneous Suture Group (n = 57). The study participants and data collectors were blinded to group allocations. Principal outcome: perineal pain 10 days after birth. Other outcomes: short (2 and 48 h) and long term (3 and 6 months) perineal pain after birth; short term healing; suture time.
RESULTS


At 10 days postpartum, the presence of spontaneous pain, pain when walking or moving in bed, was almost nonexistent in the 3 suture groups. The median (P25-P75) perineal pain on palpation was similar in the 3 groups, with values of 2 (1-4) in the Continuous Suture Group, 3 (2-5) in the Interrupted Cutaneous Suture Group and 2 (1-4) in the Interrupted Subcutaneous Suture Group; also were similar the perineal pain on sitting: 1 (0-3) in the Continuous Suture Group, 1 (0-2) in the Interrupted Cutaneous Suture Group and 1 (0-3) in the Interrupted Subcutaneous Suture Group. There were no statistically significant differences between the groups. Pain measurements throughout the follow-up period only showed statistically significant differences in 2 out of 22 evaluations: pain when sitting 48 h after birth and spontaneous pain at 3 months. The mean times (standard deviation) to carry out suturing were 12.86 (4.9) minutes in the Continuous Suture Group, 13.54 (5.6) in the Interrupted Cutaneous Suture Group, and 15.59 (6.9) minutes in the Interrupted Subcutaneous Suture Group (p < 0.05).
CONCLUSIONS


The three suturing methods described for perineal repair after episiotomy or second degree tearing after normal birth are comparable with respect to short, medium and long term perineal pain and the healing process. Use of the continuous suturing technique involved less time than interrupted suture methods. Tweetable abstract: proper the suturing methods for perineal repair after episiotomy or second degree tearing prevent postpartum perineal pain.",2020,Pain measurements throughout the follow-up period only showed statistically significant differences in 2 out of 22 evaluations: pain when sitting 48 h after birth and spontaneous pain at 3 months.,"['perineal repair after episiotomy or second degree tearing prevent postpartum perineal pain', 'and 2nd degree tears by midwives', 'Full term pregnant women older than 18 years-of-age, who required perineal repair after episiotomy or second degree tearing and were attended for normal birth by midwives', 'A large public university hospital in Madrid, Spain', 'One hundred and eighty-three women']","['continuous suturing technique', 'Continuous Suture Group (n\xa0=\xa058), Interrupted Cutaneous Suture Group (n\xa0=\xa053), or the Interrupted Subcutaneous Suture Group', 'perineal repair suturing techniques', 'Perineal repair of media-lateral episiotomies']","['spontaneous pain, pain when walking or moving in bed', 'perineal pain 10 days after birth', 'Pain measurements', 'median (P25-P75) perineal pain on palpation', 'mean times (standard deviation) to carry out suturing', 'perineal pain after birth; short term healing; suture time']","[{'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0443298', 'cui_str': 'Second degree'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}]","[{'cui': 'C1997216', 'cui_str': 'Spontaneous pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0578370', 'cui_str': 'Does move in bed'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}, {'cui': 'C1259013', 'cui_str': 'IL2RB protein, human'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]",183.0,0.113328,Pain measurements throughout the follow-up period only showed statistically significant differences in 2 out of 22 evaluations: pain when sitting 48 h after birth and spontaneous pain at 3 months.,"[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'López-Lapeyrere', 'Affiliation': 'Puerta de Hierro Majadahonda University Hospital. Calle Joaquín Rodrigo, 2, 28222 Majadahonda, Madrid, Spain; Nursing and Health Care Research Group, Puerta de Hierro-Segovia de Arana Health Research Institute. Calle Joaquín Rodrigo, 2, 28222 Majadahonda, Madrid, Spain. Electronic address: cllapeyrere@salud.madrid.org.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Solís-Muñoz', 'Affiliation': 'Puerta de Hierro Majadahonda University Hospital. Calle Joaquín Rodrigo, 2, 28222 Majadahonda, Madrid, Spain; Nursing and Health Care Research Group, Puerta de Hierro-Segovia de Arana Health Research Institute. Calle Joaquín Rodrigo, 2, 28222 Majadahonda, Madrid, Spain. Electronic address: montserrat.solis@salud.madrid.org.'}, {'ForeName': 'Ana Belén', 'Initials': 'AB', 'LastName': 'Hernández-López', 'Affiliation': 'Puerta de Hierro Majadahonda University Hospital. Calle Joaquín Rodrigo, 2, 28222 Majadahonda, Madrid, Spain; Nursing and Health Care Research Group, Puerta de Hierro-Segovia de Arana Health Research Institute. Calle Joaquín Rodrigo, 2, 28222 Majadahonda, Madrid, Spain. Electronic address: abhernandez2@salud.madrid.org.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rodríguez-Barrientos', 'Affiliation': 'Gerencia Asistencial de Atención Primaria, Servicio Madrileño de Salud. Calle San Martín de Porres, 6, 28035 Madrid, Spain. Electronic address: ricardo.rodriguez@salud.madrid.org.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'González-Rubio', 'Affiliation': 'Escuela Nacional de Sanidad, Instituto de Salud Carlos III, Madrid 28029, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Puerta de Hierro Majadahonda University Hospital. Calle Joaquín Rodrigo, 2, 28222 Majadahonda, Madrid, Spain.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103553']
378,32279360,Effect of resistance training on quality of life in older people with sarcopenic obesity living in long-term care institutions: A quasi-experimental study.,"AIMS AND OBJECTIVES


To measure the effect of chair resistance training (RT) on the quality of life (QoL) of older long-term care residents with sarcopenic obesity (SO).
BACKGROUND


Sarcopenia combined with obesity, commonly called SO, is considered to be related to health-related QoL. Despite concerns regarding SO-related long-term healthcare issues, intervention studies on SO residents in nursing homes are scant in Taiwan.
DESIGN


This research was a quasi-experiment conducted according to the TREND Checklist. A total of 123 older persons were enrolled from six nursing facilities. The RT was implemented between October 2015-March 2016.
METHOD


The intervention group received progressive RT with sandbags/dumbbells twice a week for 3 months, whereas the comparison group received the usual care. QoL was the major outcome variable. Data were analysed using chi-square test, Student's t test and generalised estimating equation (GEE).
RESULTS


The various definition criteria for SO can influence the results of QoL in the older persons. From the body composition perspective, in the GEE analysis, the SO cut-off points for neither skeletal muscle mass percentage (SMMp) nor appendicular skeletal muscle mass index demonstrated significant between-group differences in the QoL variable after the 3-month RT intervention. Between-group analysis revealed a significant effect of time on anxiety/depression [Exp(B): 0.41, 95% confidence interval: 0.18-0.93, p-value < .05] in participants who met all three criteria of the definition of SO (low SMMp, low handgrip strength, and obesity). RT was one of the protective factors.
CONCLUSION


In the SO group, the effect of muscle strength on QoL is greater than the effect of changes in body composition after RT.
RELEVANCE TO CLINICAL PRACTICE


This study analysed the influence of RT on QoL in subjects with different categories of SO. RT is one of the ways to promote QoL among the SO population. ClinicalTrials.gov Identifier: NCT02912338.",2020,"Between-group analysis revealed a significant effect of time on anxiety/depression [Exp(B): 0.41, 95% confidence interval: 0.18-0.93, p-value <0.05] in participants who met all three criteria of the definition of SO (low SMMp, low handgrip strength, and obesity).","['123 older persons were enrolled from six nursing facilities', 'older people with sarcopenic obesity living in long-term care institutions', 'subjects with different categories of SO', 'elderly long-term care residents with sarcopenic obesity (SO', 'older persons']","['progressive RT with sandbags/dumbbells twice a week for 3 months, whereas the comparison group received the usual care', 'resistance training', 'chair resistance training (RT']","['quality of life (QoL', 'time on anxiety/depression', 'quality of life']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0179847', 'cui_str': 'Chair'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",123.0,0.0452616,"Between-group analysis revealed a significant effect of time on anxiety/depression [Exp(B): 0.41, 95% confidence interval: 0.18-0.93, p-value <0.05] in participants who met all three criteria of the definition of SO (low SMMp, low handgrip strength, and obesity).","[{'ForeName': 'Shu-Fang', 'Initials': 'SF', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, College of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan, ROC.'}, {'ForeName': 'Shu-Ching', 'Initials': 'SC', 'LastName': 'Chiu', 'Affiliation': 'Department of Nursing, National Taipei University of Nursing & Health Sciences, Taipei, Taiwan, ROC.'}]",Journal of clinical nursing,['10.1111/jocn.15277']
379,32311627,Women's experience of induction of labor using PGE2 as an inpatient versus balloon catheter as an outpatient.,"OBJECTIVE


Induction of labor (IOL) typically involves cervical priming in an inpatient setting. Outpatient cervical priming may be a safe and cost-effective alternative. However, little is known about women's preference and the impact of outpatient cervical priming on their healthcare experience. The objective was to compare women's healthcare experiences following IOL using a balloon catheter and going home, versus prostaglandin (PG) and remaining an inpatient.
STUDY DESIGN


A randomized controlled trial was undertaken across eight Australian maternity hospitals. Between September 2015 and October 2018, 695 women with uncomplicated term singleton pregnancies were randomized. Of these, 215 and 233 women in the balloon-outpatient and PG-inpatient groups, respectively, received the allocated intervention. The PG group received Dinoprostone gel or controlled-release tape. The balloon group had a double-balloon catheter inserted and went home. Experiential and quality-of-life outcomes were measured via written questionnaire after birth. The primary outcome was a composite neonatal measure. Women's healthcare experience, health-state (EQ-5D-3 L) and pain scores are reported here.
RESULTS


Questionnaire data were available for 366 (81.7 %) women enrolled who received their treatment allocation. More women in the balloon-outpatient group reported they would choose IOL next pregnancy (49.2 % vs 38.4 %; p = 0.037) and desire the same method (72.4 % vs 61.1 %; p = 0.022). The balloon-outpatient group experienced higher pain scores at the start of IOL (median (IQR) 3(2-5) vs 2(1-4); p = 0.002) but lower scores at time of rupture of membranes (3(1-5) vs 4(2-6); p = 0.007). The EQ-5D-3 L health-utility index did not differ significantly between the groups (0.77 vs 0.78; p = 0.899).
CONCLUSIONS


Women report similar healthcare experiences following balloon-outpatient compared to PG-impatient IOL, but are more likely to desire the same method next pregnancy if IOL is required. If both options are available, then differences in experience should be shared with women, alongside differences in clinical outcomes as part of their decision-making process.",2020,"The EQ-5D-3 L health-utility index did not differ significantly between the groups (0.77 vs 0.78; p = 0.899).
","['215 and 233 women in the balloon-outpatient and PG-inpatient groups', 'Questionnaire data were available for 366 (81.7 %) women enrolled who received their treatment allocation', 'Between September 2015 and October 2018, 695 women with uncomplicated term singleton pregnancies', 'eight Australian maternity hospitals']","['double-balloon catheter inserted and went home', 'IOL using a balloon catheter and going home, versus prostaglandin (PG) and remaining an inpatient', 'Dinoprostone gel or controlled-release tape']","['EQ-5D-3 L health-utility index', 'IOL next pregnancy', ""Women's healthcare experience, health-state (EQ-5D-3 L) and pain scores"", 'Experiential and quality-of-life outcomes', 'composite neonatal measure', 'pain scores']","[{'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0020010', 'cui_str': 'Maternity Hospitals'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",695.0,0.164063,"The EQ-5D-3 L health-utility index did not differ significantly between the groups (0.77 vs 0.78; p = 0.899).
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Beckmann', 'Affiliation': 'Mater Health, Queensland, Australia; University of Queensland, School of Medicine, Queensland, Australia; Mater Research, The University of Queensland, Queensland, Australia. Electronic address: Michael.Beckmann@mater.org.au.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Acreman', 'Affiliation': 'Mater Health, Queensland, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Schmidt', 'Affiliation': 'Mater Health, Queensland, Australia.'}, {'ForeName': 'Katharina M D', 'Initials': 'KMD', 'LastName': 'Merollini', 'Affiliation': 'University of the Sunshine Coast, School of Health and Sport Sciences, Queensland, Australia.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Miller', 'Affiliation': 'Queensland University of Technology, Queensland, Australia.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.03.031']
380,31577692,Early Enteral Nutrition Is Associated With Improved Clinical Outcomes in Critically Ill Children: A Secondary Analysis of Nutrition Support in the Heart and Lung Failure-Pediatric Insulin Titration Trial.,"OBJECTIVES


The impact of early enteral nutrition on clinical outcomes in critically ill children has not been adequately described. We hypothesized that early enteral nutrition is associated with improved clinical outcomes in critically ill children.
DESIGN


Secondary analysis of the Heart and Lung Failure-Pediatric Insulin Titration randomized controlled trial.
SETTING


Thirty-five PICUs.
PATIENTS


Critically ill children with hyperglycemia requiring inotropic support and/or invasive mechanical ventilation who were enrolled for at least 48 hours with complete nutrition data.
INTERVENTIONS


Subjects received nutrition via guidelines that emphasized enteral nutrition and were classified into early enteral nutrition (enteral nutrition within 48 hr of study randomization) and no early enteral nutrition (enteral nutrition after 48 hr of study randomization, or no enteral nutrition at any time).
MEASUREMENTS AND MAIN RESULTS


Of 608 eligible subjects, 331 (54%) received early enteral nutrition. Both early enteral nutrition and no early enteral nutrition groups had similar daily caloric intake over the first 8 study days (median, 36 vs 36 kcal/kg/d; p = 0.93). After controlling for age, body mass index z scores, primary reason for ICU admission, severity of illness, and mean Vasopressor-Inotrope Score at the time of randomization, and adjusting for site, early enteral nutrition was associated with lower 90-day hospital mortality (8% vs 17%; p = 0.007), more ICU-free days (median, 20 vs 17 d; p = 0.02), more hospital-free days (median, 8 vs 0 d; p = 0.003), more ventilator-free days (median, 21 vs 19 d; p = 0.003), and less organ dysfunction (median maximum Pediatric Logistic Organ Dysfunction, 11 vs 12; p < 0.001).
CONCLUSIONS


In critically ill children with hyperglycemia requiring inotropic support and/or mechanical ventilation, early enteral nutrition was independently associated with better clinical outcomes.",2020,"Both early enteral nutrition and no early enteral nutrition groups had similar daily caloric intake over the first 8 study days (median, 36 vs 36 kcal/kg/d; p = 0.93).","['Critically Ill Children', 'critically ill children', 'Critically ill children with hyperglycemia requiring inotropic support and/or invasive mechanical ventilation who were enrolled for at least 48 hours with complete nutrition data', '608 eligible subjects, 331 (54%) received early enteral nutrition', 'critically ill children with hyperglycemia requiring inotropic support and/or mechanical ventilation, early enteral nutrition', 'Thirty-five PICUs']","['early enteral nutrition', 'nutrition via guidelines that emphasized enteral nutrition and were classified into early enteral nutrition (enteral nutrition within 48 hr of study randomization) and no early enteral nutrition (enteral nutrition after 48 hr of study randomization, or no enteral nutrition at any time']","['organ dysfunction', 'ICU admission, severity of illness, and mean Vasopressor-Inotrope Score', '90-day hospital mortality', 'daily caloric intake']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C1046445', 'cui_str': 'Picus'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0587438', 'cui_str': 'Day hospital (environment)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",608.0,0.27809,"Both early enteral nutrition and no early enteral nutrition groups had similar daily caloric intake over the first 8 study days (median, 36 vs 36 kcal/kg/d; p = 0.93).","[{'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Srinivasan', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Natalie R', 'Initials': 'NR', 'LastName': 'Hasbani', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Nilesh M', 'Initials': 'NM', 'LastName': 'Mehta', 'Affiliation': ""Department of Anesthesiology, Critical Care and Pain Medicine, Division of Critical Care, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Sharon Y', 'Initials': 'SY', 'LastName': 'Irving', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Kandil', 'Affiliation': 'Section of Pediatric Critical Care Medicine, Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'H Christine', 'Initials': 'HC', 'LastName': 'Allen', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Department of Pediatrics, The Children's Hospital of Oklahoma, Oklahoma City, OK.""}, {'ForeName': 'Katri V', 'Initials': 'KV', 'LastName': 'Typpo', 'Affiliation': ""Department of Pediatrics, Banner Children's at Diamond Children's Medical Center, Tucson, AZ.""}, {'ForeName': 'Natalie Z', 'Initials': 'NZ', 'LastName': 'Cvijanovich', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital, Oakland, CA.""}, {'ForeName': 'E Vincent S', 'Initials': 'EVS', 'LastName': 'Faustino', 'Affiliation': 'Section of Pediatric Critical Care Medicine, Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Michael S D', 'Initials': 'MSD', 'LastName': 'Agus', 'Affiliation': ""Division of Medical Critical Care, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Vinay M', 'Initials': 'VM', 'LastName': 'Nadkarni', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002135']
381,32323557,"Vitamin D Treatment Attenuates Heart Apoptosis After Coronary Artery Bypass Surgery: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.","BACKGROUND


Vitamin D plays an important role in immune system and in the regulation of inflammatory cytokines. Coronary artery bypass graft (CABG) with cardiopulmonary bypass (CPB) is associated with an extensive inflammatory response. The aim of this study is to examine the effect of vitamin D treatment on the apoptosis and inflammatory changes developed after CABG.
METHODS


This trial was conducted on 70 patients undergoing CABG with CPB. Patients were randomly administered either in placebo or in the group of orally consuming 150 000 IU vitamin D daily for 3 consecutive days before surgery. The right atrium sample was taken to assess caspases 2, 3, and 7 activity using immunohistochemistry method. The serum level of interleukin-10 (IL-10) and insulin-like growth factor 1 (IGF-1) were compared at intervals.
RESULTS


The average number of positive cells for caspases 2 and 3 were less in vitamin D group ( P  = .006 and  P  < .001, respectively). There was an increase in serum levels of IL-10 after 3 days from vitamin D treatment before surgery (vitamin D group = 4.4 ± 4.9 ng/mL and control group = 1 ± 0.5 ng/mL,  P  = .001). After operation, IL-10 increased in both groups, higher level in vitamin D group ( P  < .001). The comparison of serum IGF-1 showed significant difference after 3 days ( P  = .006) and remained higher in vitamin D group after CPB ( P  < .001).
CONCLUSIONS


These findings suggest the apoptosis rate after CPB can be reduced by vitamin D. Vitamin D treatment may improve the inflammatory status before and after surgery. Further studies are needed to confirm the antiapoptotic property of vitamin D and clinical implication.",2020,"The average number of positive cells for caspases 2 and 3 were less in vitamin D group ( P  = .006 and  P  < .001, respectively).",['70 patients undergoing CABG with CPB'],"['Coronary artery bypass graft (CABG) with cardiopulmonary bypass (CPB', 'Coronary Artery Bypass Surgery', 'vitamin D. Vitamin D', 'Placebo', 'placebo', 'Vitamin D', 'vitamin D']","['serum level of interleukin-10 (IL-10) and insulin-like growth factor 1 (IGF-1', 'average number of positive cells', 'Heart Apoptosis', 'IL-10', 'apoptosis rate', 'serum levels of IL-10']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}]",70.0,0.638586,"The average number of positive cells for caspases 2 and 3 were less in vitamin D group ( P  = .006 and  P  < .001, respectively).","[{'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Tasdighi', 'Affiliation': 'Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Manouchehr', 'Initials': 'M', 'LastName': 'Hekmat', 'Affiliation': 'Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Beheshti', 'Affiliation': 'Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Baghaei', 'Affiliation': 'Clinical Research and Development Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Mohsen', 'Initials': 'SM', 'LastName': 'Mirhosseini', 'Affiliation': 'Clinical Research and Development Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Torbati', 'Affiliation': 'Department of Pathology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Pourmotahari', 'Affiliation': 'Clinical Research and Development Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahnoosh', 'Initials': 'M', 'LastName': 'Foroughi', 'Affiliation': 'Clinical Research and Development Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420920495']
382,32374959,Endovascular Thrombectomy with or without Intravenous Alteplase in Acute Stroke.,"BACKGROUND


In acute ischemic stroke, there is uncertainty regarding the benefit and risk of administering intravenous alteplase before endovascular thrombectomy.
METHODS


We conducted a trial at 41 academic tertiary care centers in China to evaluate endovascular thrombectomy with or without intravenous alteplase in patients with acute ischemic stroke. Patients with acute ischemic stroke from large-vessel occlusion in the anterior circulation were randomly assigned in a 1:1 ratio to undergo endovascular thrombectomy alone (thrombectomy-alone group) or endovascular thrombectomy preceded by intravenous alteplase, at a dose of 0.9 mg per kilogram of body weight, administered within 4.5 hours after symptom onset (combination-therapy group). The primary analysis for noninferiority assessed the between-group difference in the distribution of the modified Rankin scale scores (range, 0 [no symptoms] to 6 [death]) at 90 days on the basis of a lower boundary of the 95% confidence interval of the adjusted common odds ratio equal to or larger than 0.8. We assessed various secondary outcomes, including death and reperfusion of the ischemic area.
RESULTS


Of 1586 patients screened, 656 were enrolled, with 327 patients assigned to the thrombectomy-alone group and 329 assigned to the combination-therapy group. Endovascular thrombectomy alone was noninferior to combined intravenous alteplase and endovascular thrombectomy with regard to the primary outcome (adjusted common odds ratio, 1.07; 95% confidence interval, 0.81 to 1.40; P = 0.04 for noninferiority) but was associated with lower percentages of patients with successful reperfusion before thrombectomy (2.4% vs. 7.0%) and overall successful reperfusion (79.4% vs. 84.5%). Mortality at 90 days was 17.7% in the thrombectomy-alone group and 18.8% in the combination-therapy group.
CONCLUSIONS


In Chinese patients with acute ischemic stroke from large-vessel occlusion, endovascular thrombectomy alone was noninferior with regard to functional outcome, within a 20% margin of confidence, to endovascular thrombectomy preceded by intravenous alteplase administered within 4.5 hours after symptom onset. (Funded by the Stroke Prevention Project of the National Health Commission of the People's Republic of China and the Wu Jieping Medical Foundation; DIRECT-MT ClinicalTrials.gov number, NCT03469206.).",2020,"Endovascular thrombectomy alone was noninferior to combined intravenous alteplase and endovascular thrombectomy with regard to the primary outcome (adjusted common odds ratio, 1.07; 95% confidence interval, 0.81 to 1.40; P = 0.04 for noninferiority) but was associated with lower percentages of patients with successful reperfusion before thrombectomy (2.4% vs. 7.0%) and overall successful reperfusion (79.4% vs. 84.5%).","['1586 patients screened, 656 were enrolled, with 327 patients assigned to the thrombectomy-alone group and 329 assigned to the combination-therapy group', 'Patients with acute ischemic stroke from large-vessel occlusion in the anterior circulation', 'Acute Stroke', 'patients with acute ischemic stroke', '41 academic tertiary care centers in China to evaluate', 'Chinese patients with acute ischemic stroke']","['Endovascular Thrombectomy with or without Intravenous Alteplase', 'endovascular thrombectomy with or without intravenous alteplase', 'endovascular thrombectomy alone (thrombectomy-alone group) or endovascular thrombectomy preceded by intravenous alteplase']","['Mortality', 'death and reperfusion of the ischemic area', 'distribution of the modified Rankin scale scores', 'overall successful reperfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",656.0,0.189257,"Endovascular thrombectomy alone was noninferior to combined intravenous alteplase and endovascular thrombectomy with regard to the primary outcome (adjusted common odds ratio, 1.07; 95% confidence interval, 0.81 to 1.40; P = 0.04 for noninferiority) but was associated with lower percentages of patients with successful reperfusion before thrombectomy (2.4% vs. 7.0%) and overall successful reperfusion (79.4% vs. 84.5%).","[{'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yongwei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yongxin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Kilian M', 'Initials': 'KM', 'LastName': 'Treurniet', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Wenhuo', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jiyue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Shouchun', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Congguo', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hongchao', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Conghui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Xincan', 'Initials': 'X', 'LastName': 'Yue', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lou', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hansheng', 'Initials': 'H', 'LastName': 'Shu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Dianjing', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Fuqiang', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Kaifu', 'Initials': 'K', 'LastName': 'Ke', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Haicheng', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Huaizhang', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Tianxiao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Zifu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xing', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Qinghai', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yibin', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Laixing', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yansheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Xihua', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Longde', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Hong', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Benqiang', 'Initials': 'B', 'LastName': 'Deng', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2001123']
383,32326133,A Metabolically Healthy Profile Is a Transient Stage When Exercise and Diet Are Not Supervised: Long-Term Effects in the EXERDIET-HTA Study.,"Metabolically unhealthy obesity (MUO) is a regular state in people with primary hypertension (HTN), obesity, and who are physically inactive. To achieve and maintain a metabolically healthy overweight/obese (MHO) state should be a main treatment goal. The aims of the study were (1) to determine differences in metabolic profiles of overweight/obese, physically inactive individuals with HTN following a 16-week (POST) supervised aerobic exercise training (SupExT) intervention with an attentional control (AC) group, and (2) to determine whether the changes observed were maintained following six months (6 M) of unsupervised time. Participants (n = 219) were randomly assigned into AC or SupExT groups. All participants underwent a hypocaloric diet. At POST, all participants received diet and physical activity advice for the following 6 M, with no supervision. All measurements were assessed pre-intervention (PRE), POST, and after 6 M. From PRE to POST, MUO participants became MHO with improved ( p  < 0.05) total cholesterol (TC, ∆ = -12.1 mg/dL), alanine aminotransferase (∆ = -8.3 U/L), glucose (∆ = -5.5 mg/dL), C-reactive protein (∆ = -1.4 mg/dL), systolic blood pressure (SBP), and cardiorespiratory fitness (CRF) compared to unhealthy optimal cut-off values. However, after 6 M, TC, glucose, and SBP returned to unhealthy values ( p  < 0.05). In a non-physically active population with obesity and HTN, a 16-week SupExT and diet intervention significantly improves cardiometabolic profile from MUO to MHO. However, after 6 M of no supervision, participants returned to MUO. The findings of this study highlight the need for regular, systematic, and supervised diet and exercise programs to avoid subsequent declines in cardiometabolic health.",2020,"However, after 6 M, TC, glucose, and SBP returned to unhealthy values ( p  < 0.05).","['Participants (n = 219', 'metabolically healthy overweight/obese (MHO) state', 'people with primary hypertension (HTN), obesity, and who are physically inactive', 'overweight/obese, physically inactive individuals with HTN following a 16-week (POST) supervised']","['SupExT and diet intervention', 'Metabolically unhealthy obesity (MUO', 'hypocaloric diet', 'aerobic exercise training (SupExT) intervention with an attentional control (AC']","['systolic blood pressure (SBP), and cardiorespiratory fitness (CRF', 'alanine aminotransferase', 'cardiometabolic profile', 'TC, glucose, and SBP', 'total cholesterol']","[{'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",219.0,0.0262249,"However, after 6 M, TC, glucose, and SBP returned to unhealthy values ( p  < 0.05).","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Corres', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Simon M', 'Initials': 'SM', 'LastName': 'Fryer', 'Affiliation': 'School of Sport and Exercise, Oxstalls Campus, University of Gloucestershire, Gloucester GL2 9HW, UK.'}, {'ForeName': 'Aitor Martínez', 'Initials': 'AM', 'LastName': 'Aguirre-Betolaza', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Ilargi', 'Initials': 'I', 'LastName': 'Gorostegi-Anduaga', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Arratibel-Imaz', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Pérez-Asenjo', 'Affiliation': 'Cardiology Unit, Igualatorio Médico Quirúrgico (IMQ-Amárica), 01005 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Francisco-Terreros', 'Affiliation': 'Clinical Trials Unit, Health and Quality of Life Area, TECNALIA, 01009 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Saracho', 'Affiliation': 'Nefrology Department, Osakidetza, Hospital University of Araba, 01009 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Maldonado-Martín', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17082830']
384,32326177,"Targeted Breast Milk Fortification for Very Low Birth Weight (VLBW) Infants: Nutritional Intake, Growth Outcome and Body Composition.","Despite improvements in nutritional management, preterm infants continue to face high rates of postnatal growth restriction. Because variability in breast milk composition may result in protein and energy deficits, targeted fortification has been advocated. We conducted an interventional study to compare body composition and growth outcomes of very low birth weight infants fed targeted protein-fortified human milk (HM) with those fed standard fortified HM. If mother's own milk was not available, donor milk was used. Weekly analysis of HM with mid-infrared spectroscopy was conducted and additional protein was added to the fortified HM to ensure a protein intake of 4 g/kg/day. Weekly anthropometric measurements were done. Prior to discharge or at 37 weeks, corrected age skinfold thickness (SFT) measurements as well as body composition measurement using air displacement plethysmography were done. Among 36 preterm infants enrolled, those in the targeted group ( n  = 17) received more protein and had a larger flank SFT at study end than those in the standard group ( n  = 19). A pilot post-hoc analysis of subjects having at least 30 intervention days showed a 3% higher fat-free mass in the targeted group. Use of a targeted fortification strategy resulted in a higher protein intake and fat-free mass among those receiving longer intervention.",2020,Use of a targeted fortification strategy resulted in a higher protein intake and fat-free mass among those receiving longer intervention.,"['very low birth weight infants fed', 'Very Low Birth Weight (VLBW) Infants', '36 preterm infants enrolled, those in the targeted group ( n  = 17) received more protein and had a larger flank SFT at study end than those in the standard group ( n  = 19']",['targeted protein-fortified human milk (HM) with those fed standard fortified HM'],"['Nutritional Intake, Growth Outcome and Body Composition', 'higher protein intake and fat-free mass']","[{'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0230171', 'cui_str': 'Structure of lateral region of abdomen'}, {'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}]",36.0,0.0283307,Use of a targeted fortification strategy resulted in a higher protein intake and fat-free mass among those receiving longer intervention.,"[{'ForeName': 'Sumesh', 'Initials': 'S', 'LastName': 'Parat', 'Affiliation': 'Department of Pediatrics at MetroHealth Medical Center, Cleveland, OH 44109, USA.'}, {'ForeName': 'Praneeta', 'Initials': 'P', 'LastName': 'Raza', 'Affiliation': 'Neurological Institute, Cleveland Clinic, Cleveland, OH 44106, USA.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Kamleh', 'Affiliation': 'Health Economics and Outcomes Research, Covance Market Access, Houston, TX 77018, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Super', 'Affiliation': 'Department of Pediatrics at MetroHealth Medical Center, Cleveland, OH 44109, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Groh-Wargo', 'Affiliation': 'Department of Pediatrics at MetroHealth Medical Center, Cleveland, OH 44109, USA.'}]",Nutrients,['10.3390/nu12041156']
385,32326179,Three-Dimensional Ankle Exercise with Combined Isotonic Technique for an Obese Subject with Plantar Fasciitis: A Case Study.,"Background and objectives:  Obese people have many foot-related disorders and plantar fasciitis (PF) is the most common disorder among them. However, research on the role of therapeutic exercises in PF is lacking and there is no evidence to suggest its benefits. As such, a further insight into therapeutic exercises is needed within this group. This case study investigated the effect of three-dimensional (3D) ankle exercises using a combined isotonic (CI) technique on function and balance in an obese subject with PF.  Material and methods:  The subject in this study was a 28-year-old obese woman who was diagnosed with PF by an orthopedic surgeon. A 3D ankle exercise program was commenced three times a week for 15 min over 4 weeks. The evaluations were conducted at five intervals: pre-test, and at 1, 2, 3 and 4 weeks from the initiation of the intervention. The tests were conducted in the following order: the patient-specific functional scale test (PSFS), an ultrasound of the plantar fascia, the heel pressure and balance test, the pressure pain threshold (PPT), and the 4-way ankle strength test.  Results:  The mean score of the PSFS test reduced by 70.55% after 4 weeks of the intervention. The thickness of the plantar fascia and heel pressure measured during single-leg standing decreased by 6.67% and 10.37%, respectively, after 4 weeks of the intervention. The anteroposterior and medial-lateral balance ability showed improvements of 8.29% and 8.61%, respectively, after 4 weeks of the intervention. The PPT improved by 38.01% after 4 weeks of the intervention. In the 4-way ankle strength test, dorsiflexion, plantar flexion, inversion, and eversion increased by 14.46%, 9.63%, 4.3% and 13.25%, respectively, after 4 weeks of the intervention.  Conclusion:  3D ankle exercises utilizing the CI technique were shown to be effective in improving foot function, pressure pain, and muscle strength in dorsiflexion and inversion in an obese patient with PF.",2020,"The anteroposterior and medial-lateral balance ability showed improvements of 8.29% and 8.61%, respectively, after 4 weeks of the intervention.","['obese subject with PF', 'obese patient with PF', 'Obese Subject with Plantar Fasciitis', '28-year-old obese woman who was diagnosed with PF by an orthopedic surgeon']","['patient-specific functional scale test (PSFS), an ultrasound of the plantar fascia, the heel pressure and balance test, the pressure pain threshold (PPT), and the 4-way ankle strength test', 'three-dimensional (3D) ankle exercises using a combined isotonic (CI) technique', 'Dimensional Ankle Exercise with Combined Isotonic Technique']","['4-way ankle strength test, dorsiflexion, plantar flexion, inversion, and eversion', 'mean score of the PSFS test', 'thickness of the plantar fascia and heel pressure measured during single-leg standing', 'foot function, pressure pain, and muscle strength in dorsiflexion and inversion', 'PPT']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}]","[{'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1813909', 'cui_str': '4-Way'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0454369', 'cui_str': 'Ankle exercises'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1813909', 'cui_str': '4-Way'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}]",,0.0279969,"The anteroposterior and medial-lateral balance ability showed improvements of 8.29% and 8.61%, respectively, after 4 weeks of the intervention.","[{'ForeName': 'Kyung-Sun', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Industrial Health, College of Health Sciences, Catholic University of Pusan, Busan 46252, Korea.'}, {'ForeName': 'Du-Jin', 'Initials': 'DJ', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Catholic University of Pusan, Busan 46252, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56040190']
386,32327366,The Effect of Dry Needling on Lower Limb Dysfunction in Poststroke Survivors.,"BACKGROUND


Spasticity is one of the main complications in poststroke survivors leading to difficulties in walking and standing resulting in high levels of disability.
OBJECTIVE


The aim of the study was to investigate the effects of deep dry needling on lower limb dysfunction in poststroke spastic patients.
METHODS


A randomized clinical trial conducted in poststroke survivors who were assigned to one of 2 groups: Deep dry needling (intervention group) and sham dry needling (control group). The primary outcome measures were Modified Modified Ashworth Scale (MMAS) and functional tests (timed up and go test, 10-meter walk test). Secondary outcome measures were active ankle dorsiflexion range of motion (AROM), passive ankle dorsiflexion range of motion (PROM), single leg stance test, and Barthel index. All measurements were assessed at baseline (T0), immediately after the third session 1 week later (T1), and 1 month after the end of the intervention (T2).
RESULTS


We recruited 24 patients (71% male; mean age 57 ± 10 years; 26.4 ± 1.8 kg•m -2 ; time since event: 25.2 ± 12.5 months). There were significant improvements in MMAS, timed up and go test, 10-meter walk test, Barthel scale, and PROM (P < .05) in the intervention group compared to controls across the time-points. There were no significant improvements in AROM assessments (P > .05).
CONCLUSIONS


Deep dry needling decreases muscle spasticity and improves lower limb function and gait speed in poststroke survivors.",2020,"There were significant improvements in MMAS, timed up and go test, 10-meter walk test, Barthel scale, and PROM (P < .05) in the intervention group compared to controls across the time-points.","['24 patients (71% male; mean age 57 ± 10 years; 26.4 ± 1.8 kg•m -2 ; time since event: 25.2 ± 12.5 months', 'poststroke survivors who were assigned to one of 2 groups', 'Poststroke Survivors', 'poststroke spastic patients', 'poststroke survivors']","['Deep dry needling (intervention group) and sham dry needling (control group', 'Dry Needling', 'deep dry needling']","['active ankle dorsiflexion range of motion (AROM), passive ankle dorsiflexion range of motion (PROM), single leg stance test, and Barthel index', 'Lower Limb Dysfunction', 'Modified Modified Ashworth Scale (MMAS) and functional tests (timed up and go test, 10-meter walk test', 'MMAS, timed up and go test, 10-meter walk test, Barthel scale, and PROM', 'lower limb function and gait speed', 'AROM assessments']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1444228', 'cui_str': 'Range of motion assessment'}]",71.0,0.0986201,"There were significant improvements in MMAS, timed up and go test, 10-meter walk test, Barthel scale, and PROM (P < .05) in the intervention group compared to controls across the time-points.","[{'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Ghannadi', 'Affiliation': 'Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ardalan', 'Initials': 'A', 'LastName': 'Shariat', 'Affiliation': 'Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: ardalansh2002@gmail.com.'}, {'ForeName': 'Noureddin Nakhostin', 'Initials': 'NN', 'LastName': 'Ansari', 'Affiliation': 'Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran; Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Tavakol', 'Affiliation': 'Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Honarpishe', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Dommerholt', 'Affiliation': 'Bethesda Physiocare, Bethesda, Maryland; Myopain Seminars, Bethesda, Maryland.'}, {'ForeName': 'Pardis', 'Initials': 'P', 'LastName': 'Noormohammadpour', 'Affiliation': 'Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ingle', 'Affiliation': 'Sport, Health & Exercise Science, University of Hull, Kingston-upon-Hull, United Kingdom.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104814']
387,31264565,A Stepped Wedge Cluster-Randomized Trial Assessing the Impact of a Riverbank Filtration Intervention to Improve Access to Safe Water on Health in Rural India.,"Sustainable and low-cost methods for delivery of safe drinking water in resource-limited settings remain suboptimal, which contributes to global diarrhea morbidity. We aimed to assess whether delivery of riverbank filtration-treated water to newly installed water storage tanks (improved quality and access, intervention condition) reduced reported diarrhea in comparison to delivery of unfiltered river water (improved access alone, control condition) in rural Indian villages. We used a stepped wedge cluster-randomized trial (SW-CRT) design involving four clusters (villages). Selection criteria included village size, proximity to a river, and lack of existing or planned community-level safe water sources. All adults and children were eligible for enrollment. All villages started in the control condition and were sequentially randomized to receive the intervention at 3-month intervals. Our primary outcome was 7-day-period prevalence of self- or caregiver-reported diarrhea, measured at 3-month intervals (five time points). Analysis was by intention to treat. Because blinding was not possible, we incorporated questions about symptoms unrelated to water consumption to check response validity (negative control symptoms). We measured outcomes in 2,222 households (9,836 participants). We did not find a measurable reduction in diarrhea post-intervention (RR: 0.98 [95% CI: 0.24-4.09]); possible explanations include low intervention uptake, availability of other safe water sources, low baseline diarrheal prevalence, and reporting fatigue. Our study highlights both the difficulties in evaluating the impact of real-world interventions and the potential for an optimized SW-CRT design to address budgetary, funding, and logistical constraints inherent in such evaluations.",2020,"We did not find a measurable reduction in diarrhea post-intervention (RR: 0.98 [95% CI: 0.24-4.09]); possible explanations include low intervention uptake, availability of other safe water sources, low baseline diarrheal prevalence, and reporting fatigue.","['rural Indian villages', 'Health in Rural India', '2,222 households (9,836 participants', 'All adults and children were eligible for enrollment']","['Riverbank Filtration Intervention', 'unfiltered river water (improved access alone and control condition', 'riverbank filtration-treated water to newly installed water storage tanks']","['diarrhea post-intervention', '7-day-period prevalence of self- or caregiver-reported diarrhea']","[{'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C1720497', 'cui_str': 'River water'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0337123', 'cui_str': 'Storage tank, device (physical object)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",9836.0,0.195914,"We did not find a measurable reduction in diarrhea post-intervention (RR: 0.98 [95% CI: 0.24-4.09]); possible explanations include low intervention uptake, availability of other safe water sources, low baseline diarrheal prevalence, and reporting fatigue.","[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'McGuinness', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': ""O'Toole"", 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Forbes', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Boving', 'Affiliation': 'Department of Civil and Environmental Engineering, University of Rhode Island, Kingston, Rhode Island.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Patil', 'Affiliation': 'The Energy and Resources Institute (TERI), Goa, India.'}, {'ForeName': 'Fraddry', 'Initials': 'F', 'LastName': ""D'Souza"", 'Affiliation': 'The Energy and Resources Institute (TERI), Goa, India.'}, {'ForeName': 'Chetan A', 'Initials': 'CA', 'LastName': 'Gaonkar', 'Affiliation': 'The Energy and Resources Institute (TERI), Goa, India.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Giriyan', 'Affiliation': 'The Energy and Resources Institute (TERI), Goa, India.'}, {'ForeName': 'S Fiona', 'Initials': 'SF', 'LastName': 'Barker', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sinclair', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Leder', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0260']
388,32114516,Percutaneous coronary intervention versus medical therapy in patients with angina and grey-zone fractional flow reserve values: a randomised clinical trial.,"INTRODUCTION


There is conflicting evidence regarding the benefits of percutaneous coronary intervention (PCI) in patients with grey zone fractional flow reserve ( GZ FFR artery) values (0.75-0.80). The prevalence of ischaemia is unknown. We wished to define the prevalence of ischaemia in  GZ FFR artery and assess whether PCI is superior to optimal medical therapy (OMT) for angina control.
METHODS


We enrolled 104 patients with angina with 1:1 randomisation to PCI or OMT. The artery was interrogated with a Doppler flow/pressure wire. Patients underwent Magnetic Resonance Imaging (MRI) with follow-up at 3 and 12 months. The primary outcome was angina status at 3 months using the Seattle Angina Questionnaire (SAQ).
RESULTS


104 patients (age 60±9 years), 79 (76%) males and 79 (76%) Left Anterior Descending (LAD) stenoses were randomised. Coronary physiology and SAQ were similar. Of 98 patients with stress perfusion MRI data, 17 (17%) had abnormal perfusion (≥2 segments with ≥25% ischaemia or ≥1 segment with ≥50% ischaemia) in the target  GZ FFR artery. Of 89 patients with invasive physiology data, 26 (28%) had coronary flow velocity reserve <2.0 in the target  GZ FFR artery. After 3 months of follow-up, compared with patients treated with OMT only, patients treated by PCI and OMT had greater improvements in SAQ angina frequency (21 (28) vs 10 (23); p=0.026) and quality of life (24 (26) vs 11 (24); p=0.008) though these differences were no longer significant at 12 months.
CONCLUSIONS


Non-invasive evidence of major ischaemia is uncommon in patients with  GZ FFR artery. Compared with OMT alone, patients randomised to undergo PCI reported improved symptoms after 3 months but these differences were no longer significant after 12 months.
TRIAL REGISTRATION NUMBER


NCT02425969.",2020,"Compared with OMT alone, patients randomised to undergo PCI reported improved symptoms after 3 months but these differences were no longer significant after 12 months.
","['patients with angina and grey-zone fractional flow reserve values', '104 patients with angina with 1:1 randomisation to PCI or OMT', 'patients with  GZ FFR artery', '89 patients with invasive physiology data, 26 (28%) had coronary flow velocity reserve <2.0 in the target  GZ FFR artery', '104 patients (age 60±9 years), 79 (76%) males and 79 (76', '98 patients with stress perfusion MRI data, 17 (17%) had abnormal perfusion (≥2 segments with ≥25% ischaemia or ≥1 segment with ≥50% ischaemia) in the target']","['percutaneous coronary intervention (PCI', 'Magnetic Resonance Imaging (MRI', 'OMT', 'Percutaneous coronary intervention versus medical therapy']","['SAQ angina frequency', 'quality of life', 'Coronary physiology and SAQ', 'angina status at 3 months using the Seattle Angina Questionnaire (SAQ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",104.0,0.144313,"Compared with OMT alone, patients randomised to undergo PCI reported improved symptoms after 3 months but these differences were no longer significant after 12 months.
","[{'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Hennigan', 'Affiliation': 'Cardiology Department, Golden Jubilee National Hospital, Glasgow, United Kingdom barrywhennigan@gmail.com.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'Cardiology Department, Golden Jubilee National Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Collison', 'Affiliation': 'Cardiology Department, Golden Jubilee National Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Corcoran', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Science, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Eteiba', 'Affiliation': 'Cardiology Department, Golden Jubilee National Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Good', 'Affiliation': 'Cardiology Department, Golden Jubilee National Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McEntegart', 'Affiliation': 'Cardiology Department, Golden Jubilee National Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Watkins', 'Affiliation': 'Cardiology Department, Golden Jubilee National Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'McClure', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Science, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mangion', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Science, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Thomas Joseph', 'Initials': 'TJ', 'LastName': 'Ford', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Science, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Science, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Hood', 'Affiliation': 'Cardiology Department, Golden Jubilee National Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rocchiccioli', 'Affiliation': 'Cardiology Department, Golden Jubilee National Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Aadil', 'Initials': 'A', 'LastName': 'Shaukat', 'Affiliation': 'Cardiology Department, Golden Jubilee National Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Lindsay', 'Affiliation': 'Cardiology Department, Golden Jubilee National Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'Cardiology Department, Golden Jubilee National Hospital, Glasgow, United Kingdom.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-316075']
389,32270959,Infra-Abdominal Muscles Activation Brings Benefits to the Pulmonary Function of Patients with Sternal Instability after Cardiac Surgery.,"OBJECTIVE


To compare physical therapy strategies involving abdominal muscle stabilization, with and without upper limb movement, in patients with sternal instability after heart surgery and during in-hospital care.
METHODS


This prospective, longitudinal, randomized, and comparative clinical study included 20 patients, which were divided into two groups: ARM, the arm group (n=10), and LEG, the leg group (n=10). The study involved the evaluation of scores of visual analog scales for sternal instability, pain, discomfort, functional impairment, lung function, and maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) before and after the interventions. Two protocols consisting of abdominal exercises in both groups with upper limb movements (ARM) and just abdominal activation with leg movements (LEG) were used for three weeks.
RESULTS


There were statistically significant (P≤0.01) improvements in pain, discomfort, and functional impairment scores, and in MIP (P=0.04) and MEP (P≤0.01) after intervention in both groups and just LEG showed improvement in forced vital capacity (P=0.043) and forced expiratory volume in one second (P=0.011).
CONCLUSION


Both strategies promoted improvement in pain, discomfort, and functional impairment scores and in the values of inspiratory and expiratory pressures. Perhaps they were influenced by the time and resolution of the infection process, although exercises with upper limb movements seem to be safe in this population. The activation of the infra-abdominal muscles through leg movements seems to bring more benefits to lung function.",2020,"Both strategies promoted improvement in pain, discomfort, and functional impairment scores and in the values of inspiratory and expiratory pressures.","['20 patients', 'Patients with Sternal Instability after Cardiac Surgery', 'patients with sternal instability after heart surgery and during in-hospital care']","['abdominal exercises', 'just abdominal activation with leg movements (LEG']","['forced vital capacity', 'pain, discomfort, and functional impairment scores, and in MIP', 'forced expiratory volume', 'values of inspiratory and expiratory pressures', 'pain, discomfort, and functional impairment scores', 'visual analog scales for sternal instability, pain, discomfort, functional impairment, lung function, and maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0454354', 'cui_str': 'Abdominal exercises'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}]",20.0,0.0210973,"Both strategies promoted improvement in pain, discomfort, and functional impairment scores and in the values of inspiratory and expiratory pressures.","[{'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Nozawa', 'Affiliation': 'Universidade de São Paulo Faculdade de Medicina Hospital das Clínicas São Paulo SP Brazil Department of Physiotherapy of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor/HC-FMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Cristiane Domingues', 'Initials': 'CD', 'LastName': 'Gonçalves', 'Affiliation': 'Universidade de São Paulo Faculdade de Medicina Hospital das Clínicas São Paulo SP Brazil Department of Physiotherapy of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor/HC-FMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Patricia Oliva de', 'Initials': 'PO', 'LastName': 'Almeida', 'Affiliation': 'Universidade de São Paulo Faculdade de Medicina Hospital das Clínicas São Paulo SP Brazil Department of Physiotherapy of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor/HC-FMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Ludhmila Abrahão', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Universidade de São Paulo Faculdade de Medicina Hospital das Clínicas São Paulo SP Brazil Department of Critical Patients of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor/HC-FMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Filomena Regina Gomes', 'Initials': 'FRG', 'LastName': 'Galas', 'Affiliation': 'Universidade de São Paulo Faculdade de Medicina Hospital das Clínicas São Paulo SP Brazil Department of Anesthesia and Surgical Intensive Care of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor/HC-FMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Ignêz Zanetti', 'Initials': 'MIZ', 'LastName': 'Feltrim', 'Affiliation': 'Universidade de São Paulo Faculdade de Medicina Hospital das Clínicas São Paulo SP Brazil Department of Physiotherapy of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor/HC-FMUSP), São Paulo, SP, Brazil.'}]",Brazilian journal of cardiovascular surgery,['10.21470/1678-9741-2018-0365']
390,32320844,Protocol for an embedded pragmatic clinical trial to test the effectiveness of Aliviado Dementia Care in improving quality of life for persons living with dementia and their informal caregivers.,"INTRODUCTION


Persons living with Alzheimer's disease and related dementias (ADRD) frequently experience pain and behavioral and psychological symptoms of dementia (BPSD) which decrease quality of life (QOL) and influence caregiver burden. Home healthcare professionals however may underrecognize or lack the ability to manage BPSD.
INTERVENTION


This protocol describes an ADRD palliative quality assurance performance improvement program for home healthcare, Aliviado Dementia Care-Home Health Edition. It includes training, mentoring, and a toolbox containing intervention strategies.
METHODS


This embedded pragmatic clinical trial will utilize a multi-site, cluster randomized control design. Recruitment will occur from three home healthcare agencies located in New Jersey, Utah, and Florida. At each agency, care teams will be randomized as clusters and assigned to either the Aliviado Dementia Care program or usual care. We plan to enroll 345 persons living with ADRD and their informal caregiver dyads. The primary outcome will be to measure QOL in both the person living with ADRD and their informal caregiver, and emergency department visits and hospital admissions. Secondary outcomes in the person living with ADRD will include the examination of pain, BPSD, antipsychotic and analgesic use. Secondary outcomes in caregivers include burden, depressive symptoms, functional health and wellbeing, and healthcare utilization.
CONCLUSION


This study will be the first large-scale embedded pragmatic clinical trial in home healthcare focused on care quality and outcomes in addressing QOL in ADRD. If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
TRIAL REGISTRATION


Clinical Trials.gov: NCT03255967.",2020,"If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
","[""Persons living with Alzheimer's disease and related dementias (ADRD"", '345 persons living with ADRD and their informal caregiver dyads', 'persons living with dementia and their informal caregivers']","['Aliviado Dementia Care', 'Aliviado Dementia Care program or usual care']","['caregivers include burden, depressive symptoms, functional health and wellbeing, and healthcare utilization', 'person living with ADRD will include the examination of pain, BPSD, antipsychotic and analgesic use', 'quality of life (QOL', 'quality of life', 'QOL in both the person living with ADRD and their informal caregiver, and emergency department visits and hospital admissions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",,0.117164,"If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
","[{'ForeName': 'Alycia A', 'Initials': 'AA', 'LastName': 'Bristol', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Convery', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Sotelo', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Schneider', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Shih-Yin', 'Initials': 'SY', 'LastName': 'Lin', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fletcher', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Rupper', 'Affiliation': 'University of Utah School of Medicine, United States; George E. Wahlen Department of Veterans Affairs Medical Center, VA Salt Lake City Health Care System, Geriatric Research, Education and Clinical Center, Salt Lake City, UT, United States.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Galvin', 'Affiliation': 'Comprehensive Center for Brain Health, University of Miami Miller School of Medicine, United States.'}, {'ForeName': 'Abraham A', 'Initials': 'AA', 'LastName': 'Brody', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States. Electronic address: Ab.Brody@nyu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106005']
391,32320846,Proactive health support (PaHS) - telephone-based self-management support for persons at risk of hospital admission: Study protocol for a randomized controlled trial.,"BACKGROUND


A small proportion of patients account for most of the healthcare costs. Previous studies of supportive interventions have several methodological limitations and results are mixed. This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov, NCT03628469). The main aim of the intervention is to reduce hospital admissions and improve quality of life at six months.
METHODS


A sample size of 4400 is needed and individuals with the highest risk of hospital admission in Denmark are invited by electronic communication and telephone to participate in a 1:1 randomized controlled trial. The intervention group receives one face-to-face start-up session followed by telephone sessions about individual goals regarding participants' knowledge, coping and need of healthcare. Quality of life was assessed with the mental health composite score of the SF-36v2 questionnaire. Primary analyses are done using the intention-to-treat principle.
DISCUSSION


The trial has been approved by The Regional Committee on Health Research Ethics (SJ-677). Intervention nurses do not assume clinical responsibility for the participants and the intervention is an addition to the general healthcare services. The intervention is complex due to challenging skills and behaviors required by nurses, individual tailoring of the intervention, and interacting intervention components. The study therefore includes process evaluation. The research program comprises: 1. Development initiation, 2. Intervention effect, 3. Cost-effectiveness, 4. Organizational implementation, and 5. Participants' experiences. Inclusion to the trial began April 9th, 2018, was completed July 1st, 2019 and follow-up will be completed February 1st, 2020.",2020,"This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov, NCT03628469).","['persons at risk of hospital admission', ""Participants' experiences""]","[""intervention group receives one face-to-face start-up session followed by telephone sessions about individual goals regarding participants' knowledge, coping and need of healthcare"", 'Proactive health support (PaHS) - telephone-based self-management support']","['Cost-effectiveness', 'mental health composite score of the SF-36v2 questionnaire', 'Quality of life', 'hospital admissions and improve quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.110494,"This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov, NCT03628469).","[{'ForeName': 'Kirstine Skov', 'Initials': 'KS', 'LastName': 'Benthien', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. Electronic address: kirstine.skov.benthien@regionh.dk.'}, {'ForeName': 'Knud', 'Initials': 'K', 'LastName': 'Rasmussen', 'Affiliation': 'Production, Research and Innovation, Region Zealand, Sorø, Denmark. Electronic address: kra@regionsjaelland.dk.'}, {'ForeName': 'Camilla Palmhøj', 'Initials': 'CP', 'LastName': 'Nielsen', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: camilla.palmhoj@rm.dk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hjarnaa', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. Electronic address: louise.hjarnaa@regionh.dk.'}, {'ForeName': 'Maja Kjær', 'Initials': 'MK', 'LastName': 'Rasmussen', 'Affiliation': 'Centre for Innovative Medical Technology, Odense University Hospital, Odense, Denmark. Electronic address: maja.kjaer.rasmussen@rsyd.dk.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kidholm', 'Affiliation': 'Centre for Innovative Medical Technology, Odense University Hospital, Odense, Denmark. Electronic address: kristian.kidholm@rsyd.dk.'}, {'ForeName': 'Berit Kjærside', 'Initials': 'BK', 'LastName': 'Nielsen', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: beritnie@rm.dk.'}, {'ForeName': 'Nina Konstantin', 'Initials': 'NK', 'LastName': 'Nissen', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: niniss@rm.dk.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Fredens', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: mia.fredens@rm.dk.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Winther', 'Affiliation': 'Clinical Nursing Research Unit, Aalborg University Hospital, Aalborg, Denmark. Electronic address: susanne.winther@rn.dk.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Grønkjær', 'Affiliation': 'Clinical Nursing Research Unit, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: mette.groenkjaer@rn.dk.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Toft', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. Electronic address: ulla.toft@regionh.dk.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106004']
392,32319076,Levodopa Inhalation Powder: A Review in Parkinson's Disease.,"Levodopa inhalation powder (Inbrija ® ) is approved for the intermittent treatment of OFF episodes in patients with Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor (LD-DCI) in the EU and specifically with carbidopa/levodopa in the USA. The approved dosage is 84 mg taken as needed up to five times a day. Administered via a breath-actuated inhaler, this formulation enables levodopa to bypass the gastrointestinal (GI) tract and, instead, rapidly enter the bloodstream through the pulmonary system. In the 12-week, double-blind, placebo-controlled, phase III SPAN-PD trial, as-needed levodopa inhalation powder 84 mg improved motor symptoms during OFF periods in PD patients (aged 30-86 years) treated with levodopa and carbidopa or benserazide. The likelihood of achieving an ON state 60 min postdose was significantly higher in the levodopa inhalation powder than the placebo group, with most patients in the levodopa inhalation powder group experiencing improvements in PD symptoms. Findings from longer-term, 52-week phase III studies were consistent with those from the SPAN-PD trial with regards to the treatment of OFF episodes. Levodopa inhalation powder was generally well tolerated and did not noticeably affect pulmonary function in PD patients. Providing a nonintrusive, convenient treatment method, levodopa inhalation powder is a promising option for the intermittent treatment of OFF episodes in patients with PD treated with a LD-DCI.",2020,"The likelihood of achieving an ON state 60 min postdose was significantly higher in the levodopa inhalation powder than the placebo group, with most patients in the levodopa inhalation powder group experiencing improvements in PD symptoms.","[""patients with Parkinson's disease (PD) treated with"", 'PD patients', 'PD patients (aged 30-86\xa0years) treated with', 'patients with PD treated with a LD-DCI']","['Levodopa Inhalation Powder', 'placebo', 'carbidopa/levodopa', 'levodopa and carbidopa or benserazide', 'Levodopa inhalation powder', 'Levodopa inhalation powder (Inbrija ® ', 'levodopa inhalation powder', 'levodopa/dopa-decarboxylase inhibitor (LD-DCI']","['likelihood of achieving an ON state 60\xa0min postdose', 'motor symptoms', 'pulmonary function', 'PD symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0598272', 'cui_str': 'Dopa decarboxylase inhibitor'}]","[{'cui': 'C4745728', 'cui_str': 'Levodopa Inhalation Powder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0005014', 'cui_str': 'Benserazide'}, {'cui': 'C4745523', 'cui_str': 'Inbrija'}, {'cui': 'C0598272', 'cui_str': 'Dopa decarboxylase inhibitor'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0348168,"The likelihood of achieving an ON state 60 min postdose was significantly higher in the levodopa inhalation powder than the placebo group, with most patients in the levodopa inhalation powder group experiencing improvements in PD symptoms.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Paik', 'Affiliation': 'Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}]",Drugs,['10.1007/s40265-020-01307-x']
393,32315448,Effect of self-performed mechanical plaque control frequency on gingival health in subjects with a history of periodontitis: A Randomized Clinical Trial.,"AIM


This randomized clinical trial evaluated the effect of the frequency of self-performed mechanical plaque control (SPC) on gingival health in subjects with a history of periodontitis.
MATERIALS AND METHODS


Forty-two subjects participating in a routine periodontal maintenance program were randomized to perform SPC at 12-, 24- or 48-hr intervals. Plaque index (PlI) and gingival index (GI) were evaluated at baseline, and days 15, 30 and 90 of study. Probing depths, clinical attachment levels and bleeding on probing were assessed at baseline, days 30 and 90. Mixed linear models were used for the analysis and comparison of experimental groups.
RESULTS


Mean GI at baseline remained unchanged throughout study (90 days) only in the 12-hr group (0.7 ± 0.1 versus 0.8 ± 0.1; p < .05). At the end of study, mean GI was significantly increased in the 48-hr group over that in the 12- and 24-hr groups. When GI = 2 scores were considered, only the 48-hr group failed to maintain gingival health throughout the study (18.8%).
CONCLUSION


SPC performed at a 12- or 24-hr frequency appears sufficient to controlling gingival inflammation whereas this clinical status was not maintained using a 48-hr frequency in subjects with a history of periodontitis subject to a routine periodontal maintenance program (ClinicalTrials.gov: 50208115.9.0000.5346).",2020,Mean GI at baseline remained unchanged throughout study (90 days) only in the 12-hour group (0.7±0.1 vs. 0.8±0.1; p<0.05).,"['Forty-two subjects participating in a routine periodontal maintenance program', 'subjects with a history of periodontitis', 'Subjects with a History of Periodontitis']","['self-performed mechanical plaque control (SPC', 'Self-Performed Mechanical Plaque Control Frequency']","['Probing depths, clinical attachment levels and bleeding on probing', 'maintain gingival health', 'gingival health', 'Gingival Health', 'mean GI', 'Mean GI', 'Plaque index (PlI) and gingival index (GI']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}]",42.0,0.0637548,Mean GI at baseline remained unchanged throughout study (90 days) only in the 12-hour group (0.7±0.1 vs. 0.8±0.1; p<0.05).,"[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Maier', 'Affiliation': 'Department of Stomatology, Division of Periodontology, School of Dentistry, Federal University of Santa Maria, Santa Maria, Brazil.'}, {'ForeName': 'Ana Paula Pereira', 'Initials': 'APP', 'LastName': 'Reiniger', 'Affiliation': 'Department of Stomatology, Division of Periodontology, School of Dentistry, Federal University of Santa Maria, Santa Maria, Brazil.'}, {'ForeName': 'Camila Silveira', 'Initials': 'CS', 'LastName': 'Sfreddo', 'Affiliation': 'Department of Stomatology, Division of Periodontology, School of Dentistry, Federal University of Santa Maria, Santa Maria, Brazil.'}, {'ForeName': 'Ulf Me', 'Initials': 'UM', 'LastName': 'Wikesjö', 'Affiliation': 'Laboratory for Applied Periodontal & Craniofacial Research, Adams School of Dentistry, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Karla Zanini', 'Initials': 'KZ', 'LastName': 'Kantorski', 'Affiliation': 'Department of Stomatology, Division of Periodontology, School of Dentistry, Federal University of Santa Maria, Santa Maria, Brazil.'}, {'ForeName': 'Carlos Heitor Cunha', 'Initials': 'CHC', 'LastName': 'Moreira', 'Affiliation': 'Department of Stomatology, Division of Periodontology, School of Dentistry, Federal University of Santa Maria, Santa Maria, Brazil.'}]",Journal of clinical periodontology,['10.1111/jcpe.13297']
394,32316660,Wheat Consumption Leads to Immune Activation and Symptom Worsening in Patients with Familial Mediterranean Fever: A Pilot Randomized Trial.,"We have identified a clinical association between self-reported non-celiac wheat sensitivity (NCWS) and Familial Mediterranean Fever (FMF). Objectives: A) To determine whether a 2-week double-blind placebo-controlled (DBPC) cross-over wheat vs. rice challenge exacerbates the clinical manifestations of FMF; B) to evaluate innate immune responses in NCWS/FMF patients challenged with wheat vs. rice. The study was conducted at the Department of Internal Medicine of the University Hospital of Palermo and the Hospital of Sciacca, Italy. Six female volunteers with FMF/NCWS (mean age 36 ± 6 years) were enrolled, 12 age-matched non-FMF, NCWS females, and 8 sex- and age-matched healthy subjects served as controls. We evaluated: 1. clinical symptoms by the FMF-specific AIDAI (Auto-Inflammatory Diseases Activity Index) score; 2. serum soluble CD14 (sCD14), C-reactive protein (CRP), and serum amyloid A (SSA); 3. circulating CD14 +  monocytes expressing interleukin (IL)-1β and tumor necrosis factor (TNF)-α. The AIDAI score significantly increased in FMF patients during DBPC with wheat, but not with rice (19 ± 6.3 vs. 7 ± 1.6;  p  = 0.028). sCD14 values did not differ in FMF patients before and after the challenge, but were higher in FMF patients than in healthy controls (median values 11357 vs. 8710 pg/ml;  p  = 0.002). The percentage of circulating CD14 + /IL-1β +  and of CD14 + /TNF-α +  monocytes increased significantly after DBPC with wheat vs. baseline or rice challenge. Self-reported NCWS can hide an FMF diagnosis. Wheat ingestion exacerbated clinical and immunological features of FMF. Future studies performed on consecutive FMF patients recruited in centers for auto-inflammatory diseases will determine the real frequency and relevance of this association.",2020,"sCD14 values did not differ in FMF patients before and after the challenge, but were higher in FMF patients than in healthy controls (median values 11357 vs. 8710 pg/ml;  p  = 0.002).","['Department of Internal Medicine of the University Hospital of Palermo and the Hospital of Sciacca, Italy', 'NCWS/FMF patients challenged with wheat vs. rice', 'Patients with Familial Mediterranean Fever', 'consecutive FMF patients recruited in centers for auto-inflammatory diseases', 'Six female volunteers with FMF/NCWS (mean age 36 ± 6 years) were enrolled, 12 age-matched non-FMF, NCWS females, and 8 sex- and age-matched healthy subjects served as controls']",['placebo-controlled (DBPC) cross-over wheat vs. rice challenge'],"['sCD14 values', 'percentage of circulating CD14 + /IL-1β +  and of CD14 + /TNF-α +  monocytes', 'FMF-specific AIDAI (Auto-Inflammatory Diseases Activity Index) score; 2. serum soluble CD14 (sCD14), C-reactive protein (CRP), and serum amyloid A (SSA); 3. circulating CD14 +  monocytes expressing interleukin (IL)-1β and tumor necrosis factor (TNF)-α. The AIDAI score']","[{'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0031069', 'cui_str': 'Familial Mediterranean fever'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1290884', 'cui_str': 'Inflammatory disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0035567', 'cui_str': 'Rice'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0031069', 'cui_str': 'Familial Mediterranean fever'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1290884', 'cui_str': 'Inflammatory disorder'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]",6.0,0.0332698,"sCD14 values did not differ in FMF patients before and after the challenge, but were higher in FMF patients than in healthy controls (median values 11357 vs. 8710 pg/ml;  p  = 0.002).","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Carroccio', 'Affiliation': 'Department of Health Promotion Sciences, Maternal and Infant Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, 90124 Palermo, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Mansueto', 'Affiliation': 'Department of Health Promotion Sciences, Maternal and Infant Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, 90124 Palermo, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Soresi', 'Affiliation': 'Department of Health Promotion Sciences, Maternal and Infant Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, 90124 Palermo, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fayer', 'Affiliation': 'Department of Health Promotion Sciences, Maternal and Infant Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, 90124 Palermo, Italy.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Di Liberto', 'Affiliation': 'Central Laboratory of Advanced Diagnosis and Biomedical Research (CLADIBIOR), University of Palermo, 90129 Palermo, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Monguzzi', 'Affiliation': 'Institute of Translational Immunology and Research Center for Immunotherapy, University Medical Center, Johannes Gutenberg University, 55122 Mainz, Germany.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Lo Pizzo', 'Affiliation': 'Central Laboratory of Advanced Diagnosis and Biomedical Research (CLADIBIOR), University of Palermo, 90129 Palermo, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'La Blasca', 'Affiliation': 'Department of Health Promotion Sciences, Maternal and Infant Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, 90124 Palermo, Italy.'}, {'ForeName': 'Girolamo', 'Initials': 'G', 'LastName': 'Geraci', 'Affiliation': 'Surgery Department, University of Palermo, 90129 Palermo, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Pecoraro', 'Affiliation': 'Hematology Unit for Rare Diseases, Laboratory of Molecular Genetic, Villa Sofia-Cervello, 90146 Palermo, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Dieli', 'Affiliation': 'Central Laboratory of Advanced Diagnosis and Biomedical Research (CLADIBIOR), University of Palermo, 90129 Palermo, Italy.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Schuppan', 'Affiliation': 'Institute of Translational Immunology and Research Center for Immunotherapy, University Medical Center, Johannes Gutenberg University, 55122 Mainz, Germany.'}]",Nutrients,['10.3390/nu12041127']
395,32316686,Effectiveness of Hypopressive Exercises in Women with Pelvic Floor Dysfunction: A Randomised Controlled Trial.,"Hypopressive exercises have emerged as a conservative treatment option for pelvic floor dysfunction (PFD). The aim of this study was to compare the effects of an eight-week hypopressive exercise program to those of an individualized pelvic floor muscle (PFM) training (PFMT) program, and to a combination of both immediately after treatment and at follow-up assessments at 3, 6 and 12 months later. The study was a prospective, single-centre, assessor-blinded, randomised controlled trial. Ninety-four women with PFD were assigned to PFMT ( n  = 32), hypopressive exercises ( n  = 31) or both ( n  = 31). All programs included the same educational component, and instruction about lifestyle interventions and the knack manoeuvre. Primary outcomes were the Pelvic Floor Distress Inventory Short Form (PFDI-20); the Pelvic Floor Impact Questionnaire Short Form (PFIQ-7); PFM strength (manometry and dynamometry) and pelvic floor basal tone (dynamometry). There were no statistically significant differences between groups at baseline, nor after the intervention. Overall, women reduced their symptoms (24.41-30.5 on the PFDI-20); improved their quality of life (14.78-21.49 on the PFIQ-7), improved their PFM strength (8.61-9.32 cmH 2 O on manometry; 106.2-247.7 g on dynamometry), and increased their pelvic floor basal tone (1.8-22.9 g on dynamometry). These data suggest that individual PFMT, hypopressive exercises and a combination of both interventions significantly reduce PFD symptoms, enhance quality of life, and improve PFM strength and basal tone in women with PFD, both in the short and longer term.",2020,"Overall, women reduced their symptoms (24.41-30.5 on the PFDI-20); improved their quality of life (14.78-21.49 on the PFIQ-7), improved their PFM strength (8.61-9.32 cmH 2 O on manometry; 106.2-247.7 g on dynamometry), and increased their pelvic floor basal tone (1.8-22.9 g on dynamometry).","['Ninety-four women with PFD', 'Women with Pelvic Floor Dysfunction']","['Hypopressive exercises', 'Hypopressive Exercises', 'hypopressive exercises', 'individualized pelvic floor muscle (PFM) training (PFMT) program', 'PFMT', 'eight-week hypopressive exercise program']","['pelvic floor basal tone', 'Pelvic Floor Distress Inventory Short Form (PFDI-20); the Pelvic Floor Impact Questionnaire Short Form (PFIQ-7); PFM strength (manometry and dynamometry) and pelvic floor basal tone (dynamometry', 'PFM strength', 'quality of life', 'PFD symptoms, enhance quality of life, and improve PFM strength and basal tone']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4041537', 'cui_str': 'Pelvic floor dysfunction'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4041537', 'cui_str': 'Pelvic floor dysfunction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",94.0,0.0617368,"Overall, women reduced their symptoms (24.41-30.5 on the PFDI-20); improved their quality of life (14.78-21.49 on the PFIQ-7), improved their PFM strength (8.61-9.32 cmH 2 O on manometry; 106.2-247.7 g on dynamometry), and increased their pelvic floor basal tone (1.8-22.9 g on dynamometry).","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Navarro-Brazález', 'Affiliation': ""Physiotherapy in Women's Health (FPSM) Research Group. Physiotherapy Department, Faculty of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, 28805 Madrid, Spain.""}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Prieto-Gómez', 'Affiliation': ""Physiotherapy in Women's Health (FPSM) Research Group. Physiotherapy Department, Faculty of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, 28805 Madrid, Spain.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Prieto-Merino', 'Affiliation': ""Physiotherapy in Women's Health (FPSM) Research Group. Physiotherapy Department, Faculty of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, 28805 Madrid, Spain.""}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Sánchez-Sánchez', 'Affiliation': ""Physiotherapy in Women's Health (FPSM) Research Group. Physiotherapy Department, Faculty of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, 28805 Madrid, Spain.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'McLean', 'Affiliation': 'School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa, ON K1H 8M5, Canada.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Torres-Lacomba', 'Affiliation': ""Physiotherapy in Women's Health (FPSM) Research Group. Physiotherapy Department, Faculty of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, 28805 Madrid, Spain.""}]",Journal of clinical medicine,['10.3390/jcm9041149']
396,32316689,"Alcohol Hangover and Multitasking: Effects on Mood, Cognitive Performance, Stress Reactivity, and Perceived Effort.","The aim of this study was to examine the effects of hangover on mood, multitasking ability, and psychological stress reactivity to cognitive demand. Using a crossover design and semi-naturalistic methodology, 25 participants attended the laboratory in the morning following a night of (i) alcohol abstinence and (ii) alcohol self-administration during a typical night out (with order counterbalanced across participants). They completed a four-module multitasking framework (MTF, a widely used laboratory stressor) and a battery of questionnaires assessing mood, hangover symptom severity, and previous night's sleep. The effects of the MTF on mood and perceived workload were also assessed. Participants in the hangover condition reported significantly lower alertness and contentment coupled with a higher mental fatigue and anxiety. Multitasking ability was also significantly impaired in the hangover condition. Completion of the cognitive stressor increased reported levels of mental demand, effort, and frustration, and decreased perceived level of performance. MTF completion did not differentially affect mood. Lastly, participants rated their sleep as significantly worse during the night prior to the hangover compared with the control condition. These findings confirm the negative cognitive and mood effects of hangover on mood. They also demonstrate that hangover is associated with greater perceived effort during task performance.",2020,Participants in the hangover condition reported significantly lower alertness and contentment coupled with a higher mental fatigue and anxiety.,['25 participants attended the laboratory in the morning following a night of (i) alcohol abstinence and (ii) alcohol self-administration during a typical night out (with order counterbalanced across participants'],"['MTF', 'Alcohol Hangover and Multitasking']","['Multitasking ability', 'mental fatigue and anxiety', 'Mood, Cognitive Performance, Stress Reactivity, and Perceived Effort', 'levels of mental demand, effort, and frustration, and decreased perceived level of performance']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0678274', 'cui_str': 'Alcohol Abstinence'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0393756', 'cui_str': 'Hangover'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016770', 'cui_str': 'Feeling frustrated'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",25.0,0.0291446,Participants in the hangover condition reported significantly lower alertness and contentment coupled with a higher mental fatigue and anxiety.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ayre', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Garrisson', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Wetherell', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia.'}, {'ForeName': 'Joris C', 'Initials': 'JC', 'LastName': 'Verster', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Scholey', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia.'}]",Journal of clinical medicine,['10.3390/jcm9041154']
397,32311349,Pneumonia and Exposure to Household Air Pollution in Children Under the Age of 5 Years in Rural Malawi: Findings From the Cooking and Pneumonia Study.,"BACKGROUND


Exposure to household air pollution is associated with an increased risk of pneumonia in children in low- and middle-income countries; however, exposure-response data are limited, and there are uncertainties around the extent to which biomass-fueled cookstoves can reduce these exposures.
RESEARCH QUESTION


What is the association between exposure to household air pollution and pneumonia in children under the age of 5 years in rural Malawi and what are the effects of a biomass-fueled cookstove intervention on personal exposure to household air pollution?
STUDY DESIGN AND METHODS


We measured personal exposure to carbon monoxide (CO; 48 hours of continuous measurement and transcutaneous carboxyhemoglobin) every 6 months in children who participated in a cluster-randomized controlled trial of a cleaner burning biomass-fueled cookstove intervention to prevent pneumonia in children under the age of 5 years in rural Malawi (the Cooking And Pneumonia Study). Exposure-response and multivariable analyses were done.
RESULTS


We recruited 1805 (928 intervention; 877 control) children (mean age, 25.6 months; 50.6% female). We found no evidence of an association between exposure to CO (incident rate ratio, 1.0; 95% CI, 0.967 to 1.014; P = .53) or carboxyhemoglobin (incident rate ratio, 1.00; 95% CI, 0.993 to 1.003; P = .41) in children who experienced pneumonia vs those who did not. Median exposure to CO in the intervention and control groups was was 0.34 (interquartile range, 0.15 to 0.81) and 0.37 parts per million (interquartile range, 0.15 toa 0.97), respectively. The group difference in means was 0.46 (95% CI, -0.95 to 0.012; P = .06).
INTERPRETATION


Exposure to CO in our population was low with no association seen between exposure to CO and pneumonia incidence and no effect of the Cooking And Pneumonia Study intervention on these exposures. These findings suggest that CO may not be an appropriate measure of household air pollution exposure in settings such as rural Malawi and that there is a need to develop ways to measure particulate matter exposures directly in young children instead.
CLINICAL TRIAL REGISTRATION


ISRCTN59448623.",2020,"The group difference in means was 0.46 (95% CI:-0.95-0.012; p=0.06).
","['children under the age of 5 years in rural Malawi', 'children under the age of 5 years in rural Malawi - the Cooking And Pneumonia Study (CAPS', 'children participating in a cluster-randomised controlled trial of a', 'young children instead', 'We recruited 1805 (928 intervention; 877 control) children (mean age 25.6 months, 50.6% female', 'children under the age of 5 in rural Malawi']","['COHb ', 'CAPS intervention', 'personal exposure to carbon monoxide (CO', 'transcutaneous carboxyhemoglobin (COHb', 'cleaner-burning biomass-fueled cookstove intervention']",['Median exposure to CO'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0007061', 'cui_str': 'Carboxyhemoglobin'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0238889', 'cui_str': 'Exposure to carbon monoxide'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0238889', 'cui_str': 'Exposure to carbon monoxide'}]",,0.0927706,"The group difference in means was 0.46 (95% CI:-0.95-0.012; p=0.06).
","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mortimer', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK. Electronic address: Kevin.mortimer@lstmed.ac.uk.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Lesosky', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Semple', 'Affiliation': 'Stirling University, Stirling, UK.'}, {'ForeName': 'Julita', 'Initials': 'J', 'LastName': 'Malava', 'Affiliation': 'Malawi Epidemiology and Intervention Research Unit, Malawi.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Katundu', 'Affiliation': 'Malawi Epidemiology and Intervention Research Unit, Malawi.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Crampin', 'Affiliation': 'Malawi Epidemiology and Intervention Research Unit, Malawi; London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Weston', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Pope', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Havens', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Gordon', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK; Malawi Liverpool Wellcome Trust Programme, Blantyre, Malawi.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Balmes', 'Affiliation': 'University of California, Berkeley, CA; University of California, San Francisco, San Francisco, CA.'}]",Chest,['10.1016/j.chest.2020.03.064']
398,32311455,"Disposition of two highly permeable drugs in the upper gastrointestinal lumen of healthy adults after a standard high-calorie, high-fat meal.","OBJECTIVES


To quantify the presence of two model highly permeable drugs, paracetamol and danazol, in the upper gastrointestinal lumen under conditions simulating the situation after disintegration of immediate release dosage forms administered in bioavailability/bioequivalence studies in the fed state. To understand the drug transfer process from the antral contents through the upper small intestine based on luminal drug data.
METHODS


8 healthy male adult volunteers participated in a randomized, single dose, two-phase, crossover study. After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube. The drugs were administered in solution form (Phase I) and in suspension form (Phase II) with a glass of tap water to the antrum of the stomach, 30 min after the initiation of meal administration. Samples were aspirated from the antrum and the upper small intestine up to 4 hours post drug administration.
RESULTS


Apparent concentrations in the aqueous contents of the antrum were higher than apparent concentrations in the micellar contents of the upper small intestine for paracetamol; the opposite was observed for danazol. Based on total drug amount per volume data in contents of the upper gastrointestinal lumen, the transfer of paracetamol (aqueous solution or suspension) and danazol (aqueous suspension) through the upper small intestine could be described as an apparent first-order process. Transfer of a long-chain triglyceride solution of danazol was highly variable.
CONCLUSIONS


Concentrations in the aqueous/micellar phase of luminal contents and values of parameters controlling the transfer from bulk gastric contents through the upper small intestine after a high-calorie, high-fat meal, were reported for the first time for highly permeable drugs. Data are expected to enhance the development of biorelevant in vitro and physiologically based biopharmaceutics modelling methodologies.",2020,"After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube.",['8 healthy male adult volunteers'],"['paracetamol and danazol', 'danazol', 'paracetamol (aqueous solution or suspension) and danazol (aqueous suspension']",[],"[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]",[],8.0,0.0387024,"After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pentafragka', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Symillides', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Goumas', 'Affiliation': 'Department of Gastroenterology, Red Cross Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105351']
399,32312607,Changes in Vertebral Arterial Blood Flow During Premanipulative Tests in Participants With Upper Cervical Spine Motion Restriction.,"OBJECTIVE


The purpose of the present study was to measure changes in blood flow velocity and volume flow rate (VFR) in the contralateral vertebral artery (VA) during end-range rotation and pre-manipulative hold at C1-C2 and to compare these measurements between participants with and without C1-C2 range of motion (ROM) restriction.
METHODS


This research was approached as an exploratory study and designed as a parallel noninterventional controlled trial with intentionally equal allocation, for studying diagnostic tests. Fifteen women and 13 men (mean age 44) were recruited (volunteer sample) in physiotherapy clinics. No participant had any current neurologic or vertebrobasilar insufficiency symptoms. The measurements of 13 participants with a limited ROM C1-C2 and 15 with no limitation were compared. Blood flow velocity and VFR in the contralateral VA were measured using color duplex Doppler imaging in 3 neck positions: neutral, maximal rotation, and pre-manipulative hold of C1-C2.
RESULTS


Pre-manipulative hold significantly (P < .01) decreased all blood flow velocity parameters and VFR, mainly in the left VA. End-range rotation showed a significant (P < .05) decrease in the peak systolic velocity in the left VA. No significant differences were found between participants grouped by the presence or absence of a C1-C2 ROM restriction.
CONCLUSION


A C1-C2 rotational ROM restriction does not appear associated with change in a significantly reduced VA blood flow due to the neck position.",2020,"RESULTS


Pre-manipulative hold significantly (P < .01) decreased all blood flow velocity parameters and VFR, mainly in the left VA.","['participants with and without C1-C2 range of motion (ROM) restriction', '13 participants with a limited ROM C1-C2 and 15 with no limitation were compared', 'Participants With Upper Cervical Spine Motion Restriction', 'Fifteen women and 13 men (mean age 44) were recruited (volunteer sample) in physiotherapy clinics']",[],"['peak systolic velocity', 'Vertebral Arterial Blood Flow', 'blood flow velocity parameters and VFR', 'blood flow velocity and volume flow rate (VFR', 'Blood flow velocity and VFR', 'current neurologic or vertebrobasilar insufficiency symptoms']","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0231589', 'cui_str': 'Limitation of joint movement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}]",[],"[{'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0042568', 'cui_str': 'Vertebrobasilar artery syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",15.0,0.0371664,"RESULTS


Pre-manipulative hold significantly (P < .01) decreased all blood flow velocity parameters and VFR, mainly in the left VA.","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Leenaerts', 'Affiliation': 'Paramedisch Instituut Scheepjeshof, Veenendaal, The Netherlands. Electronic address: a.e.r.leenaerts@live.nl.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Molenaar', 'Affiliation': 'Fysiogroep Waterland, Monnickendam, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Cattrysse', 'Affiliation': 'Experimental Anatomy research group, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.10.002']
400,32187464,A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19.,"BACKGROUND


No therapeutics have yet been proven effective for the treatment of severe illness caused by SARS-CoV-2.
METHODS


We conducted a randomized, controlled, open-label trial involving hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg. Patients were randomly assigned in a 1:1 ratio to receive either lopinavir-ritonavir (400 mg and 100 mg, respectively) twice a day for 14 days, in addition to standard care, or standard care alone. The primary end point was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first.
RESULTS


A total of 199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the lopinavir-ritonavir group, and 100 to the standard-care group. Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.31; 95% confidence interval [CI], 0.95 to 1.80). Mortality at 28 days was similar in the lopinavir-ritonavir group and the standard-care group (19.2% vs. 25.0%; difference, -5.8 percentage points; 95% CI, -17.3 to 5.7). The percentages of patients with detectable viral RNA at various time points were similar. In a modified intention-to-treat analysis, lopinavir-ritonavir led to a median time to clinical improvement that was shorter by 1 day than that observed with standard care (hazard ratio, 1.39; 95% CI, 1.00 to 1.91). Gastrointestinal adverse events were more common in the lopinavir-ritonavir group, but serious adverse events were more common in the standard-care group. Lopinavir-ritonavir treatment was stopped early in 13 patients (13.8%) because of adverse events.
CONCLUSIONS


In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir-ritonavir treatment beyond standard care. Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit. (Funded by Major Projects of National Science and Technology on New Drug Creation and Development and others; Chinese Clinical Trial Register number, ChiCTR2000029308.).",2020,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","['Adults Hospitalized with Severe Covid-19', 'hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg', '199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the', 'patients with severe illness']","['lopinavir-ritonavir', 'Lopinavir-ritonavir', 'Lopinavir-Ritonavir']","['Gastrointestinal adverse events', 'serious adverse events', 'time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first', 'Mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'TS-COV19'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0222045'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",199.0,0.162561,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Danning', 'Initials': 'D', 'LastName': 'Wen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jingli', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiaan', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuelei', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Caihong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hanping', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shengjing', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fengyun', 'Initials': 'F', 'LastName': 'Gong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chongya', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiuyang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianhan', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Kunxia', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Qu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sixia', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Cheng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chunmin', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ge', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chaolin', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}]",The New England journal of medicine,['10.1056/NEJMoa2001282']
401,32193052,Effects of an individualized exercise training program on severity markers of obstructive sleep apnea syndrome: a randomised controlled trial.,"OBJECTIVE


Obstructive sleep apnea (OSA) is a high prevalent disorder with severe consequences including sleepiness, metabolic, and cardiovascular disorders. The aim of this study was to assess the effect of an individualized exercise-training (IET) program with educational sessions vs educational sessions alone on severity markers of OSA over an eight-week duration.
METHODS


This was a randomised, controlled, parallel-design study. In sum, 64 patients with moderate-to-severe OSA (apnea-hypopnea index AHI 15-45/hour), low physical activity level (Voorrips<9), body-mass index (BMI) <40 kg/m 2  were included in intervention group (IG) or control group (CG), and 54 patients finished the study. All underwent polysomnography (PSG), multiple sleep latency test (MSLT), constant workload exercise test, blood samples and fulfilled questionnaires twice. The primary endpoint was the change in apnea-hypopnea (AHI) at eight weeks from baseline. Main secondary endpoints were daytime sleepiness assessed by questionnaire and objective tests.
RESULTS


No significant between-group differences were found for changes in AHI. A reduction in AHI was found in IG only (p = 0.005). Compared to CG, exercise training leads to a greater decrease in AHI during REM sleep (p = 0.0004), with a significant increase in mean daytime sleep latency (p = 0.02). Between-group differences were significant for weight reduction, severity of fatigue, insomnia and depressive symptoms with trend for sleepiness symptoms.
CONCLUSIONS


In adult patients with moderate-to-severe OSA, IET did not decrease AHI compared to the control group but improved markers of severity of OSA, in particular AHI in rapid eye movement (REM) sleep and objective daytime sleepiness. Adding personalized exercise training to the management of patients with OSA should be considered. CLINICALTRIALS.
GOV IDENTIFIER


NCT01256307.",2020,"Between-group differences were significant for weight reduction, severity of fatigue, insomnia and depressive symptoms with trend for sleepiness symptoms.
","['64 patients with moderate-to-severe OSA (apnea-hypopnea index AHI 15-45/hour), low physical activity level (Voorrips<9), body-mass index (BMI) <40\xa0kg/m 2  were included in intervention group (IG) or control group (CG), and 54 patients finished the study', 'obstructive sleep apnea syndrome', 'patients with OSA', 'Obstructive sleep apnea (OSA']","['individualized exercise-training (IET) program with educational sessions vs educational sessions alone', 'individualized exercise training program', 'personalized exercise training']","['severity markers of OSA', 'AHI', 'weight reduction, severity of fatigue, insomnia and depressive symptoms with trend for sleepiness symptoms', 'AHI during REM sleep', 'multiple sleep latency test (MSLT), constant workload exercise test, blood samples and fulfilled questionnaires twice', 'mean daytime sleep latency', 'change in apnea-hypopnea (AHI', 'daytime sleepiness assessed by questionnaire and objective tests', 'severity of OSA, in particular AHI in rapid eye movement (REM) sleep and objective daytime sleepiness', 'changes in AHI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1521798', 'cui_str': 'With trend (attribute)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C0519186', 'cui_str': 'Multiple sleep latency test (procedure)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4075948', 'cui_str': 'Sleeps during day (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",64.0,0.01711,"Between-group differences were significant for weight reduction, severity of fatigue, insomnia and depressive symptoms with trend for sleepiness symptoms.
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bughin', 'Affiliation': 'PhyMedExp INSERM U1046 / CNRS UMR9214, Montpellier University, Montpellier, University Hospital, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Desplan', 'Affiliation': 'Specialized Medical Center Medimarien, Marcel Marien Street 21, 1030, Brussels, Belgium; LaboCenter for the Study of Sleep Disorders, Neuroscience Pole, DELTA Hospital, CHIREC, Boulevard of the Triumph 201, 1160, Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mestejanot', 'Affiliation': 'Unité du Sommeil, Centre National de Référence pour la Narcolepsie, CHU Montpellier, Hôpital Gui-de-Chauliac, Service de Neurologie, Montpellier, France.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Picot', 'Affiliation': 'Clinical Research and Epidemiology Unit, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Jaffuel', 'Affiliation': 'Department of Pneumology, Arnaud de Villeneuve, Regional University Hospital of Montpellier, 371 Avenue du Doyen Giraud, 34295, Montpellier Cedex 5, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mercier', 'Affiliation': 'PhyMedExp INSERM U1046 / CNRS UMR9214, Montpellier University, Montpellier, University Hospital, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Jaussent', 'Affiliation': 'INSERM, U1061, Neuropsychiatry, Montpellier, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'Unité du Sommeil, Centre National de Référence pour la Narcolepsie, CHU Montpellier, Hôpital Gui-de-Chauliac, Service de Neurologie, Montpellier, France; INSERM, U1061, Neuropsychiatry, Montpellier, France; University Montpellier, Montpellier, France. Electronic address: ydauvilliers@yahoo.fr.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.008']
402,32193169,Visual and cognitive processing of thin-ideal Instagram images containing idealized or disclaimer comments.,"Recent studies have demonstrated that exposure to thin-ideal social media content is associated with decreased body satisfaction, and disclaimer comments have been a proposed intervention. This experiment uses eye-tracking methods to explore the effect of disclaimer comments on participants' processing of thin-ideal Instagram images. Women ages 18-35 (N = 181) were randomly assigned to view thin-ideal Instagram images paired with one of two caption types: traditional comments that idealized the images, or disclaimer comments that critiqued the images as unrealistic. Participants' eye movements were tracked during viewing. Following exposure, participants reported their anxiety about specific body regions, as well as their perceptions of social pressure for thinness. Post-test body anxiety and perceived pressure for thinness did not differ based on experimental condition. Results indicated some differences in message processing, with similar visual attention to the model across conditions but greater attention to the comment in the disclaimer condition. Attention to the model's thighs was associated with increased body anxiety about the thighs in both conditions, whereas attention to the model's waist was associated with increased body anxiety about the waist only in the Idealized Comment condition. This indicates that the disclaimer comments were somewhat, but not entirely, effective.",2020,"Results indicated some differences in message processing, with similar visual attention to the model across conditions but greater attention to the comment in the disclaimer condition.","['Women ages 18-35 (N = 181', ""participants' processing of thin-ideal Instagram images""]","['view thin-ideal Instagram images paired with one of two caption types: traditional comments that idealized the images, or disclaimer comments that critiqued the images as unrealistic']","['Visual and cognitive processing', 'body anxiety']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0282411', 'cui_str': 'Commentary'}, {'cui': 'C0010341', 'cui_str': 'Critique'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",181.0,0.0172846,"Results indicated some differences in message processing, with similar visual attention to the model across conditions but greater attention to the comment in the disclaimer condition.","[{'ForeName': 'Amelia C', 'Initials': 'AC', 'LastName': 'Couture Bue', 'Affiliation': 'Communication Studies, University of Michigan, United States. Electronic address: ameliacc@umich.edu.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'Communication Studies, University of Michigan, United States.'}]",Body image,['10.1016/j.bodyim.2020.02.014']
403,31096264,Influence of Δ9-tetrahydrocannabinol on long-term neural correlates of threat extinction memory retention in humans.,"The neural mechanisms and durability of Δ9-tetrahydrocannabinol (THC) impact on threat processing in humans are not fully understood. Herein, we used functional MRI and psychophysiological tools to examine the influence of THC on the mechanisms of conditioned threat extinction learning, and the effects of THC on extinction memory retention when assessed 1 day and 1 week from learning. Healthy participants underwent threat conditioning on day 1. On day 2, participants were randomized to take one pill of THC or placebo (PBO) 2-h before threat extinction learning. Extinction memory retention was assessed 1 day and 1 week after extinction learning. We found that THC administration increased amygdala and ventromedial prefrontal cortex (vmPFC) activation during early extinction learning with no significant impact on skin conductance responses (SCR). When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network. When extinction memory retention was tested 1 week after learning, the THC group exhibited significantly decreased responses to the extinguished cues within the vmPFC and amygdala, but significantly increased functional coupling between the vmPFC, hippocampus, and dorsal anterior cingulate cortex during this extinction retention test. Our results are the first to report a long-term impact of one dose of THC on the functional activation of the threat extinction network and unveil a significant change in functional connectivity emerging after a week from engagement. We highlight the need for further investigating the long-term impact of THC on threat and anxiety circuitry.",2019,"When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network.","['humans', 'Healthy participants underwent threat conditioning on day 1']","['Δ9-tetrahydrocannabinol (THC', 'THC', 'Δ9-tetrahydrocannabinol', 'THC or placebo (PBO) 2-h before threat extinction learning']","['extinction memory retention', 'amygdala and ventromedial prefrontal cortex (vmPFC) activation', 'Extinction memory retention', 'functional coupling between the vmPFC, hippocampus, and dorsal anterior cingulate cortex', 'skin conductance responses (SCR']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]","[{'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]",,0.0325937,"When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network.","[{'ForeName': 'Mira Z', 'Initials': 'MZ', 'LastName': 'Hammoud', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA. mhammoud@uic.edu.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}, {'ForeName': 'Joshua R B', 'Initials': 'JRB', 'LastName': 'Hatfield', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gorka', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'Mohammed R', 'Initials': 'MR', 'LastName': 'Milad', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Rabinak', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0416-6']
404,32325751,Comparison of Obturation Removal Efficiency from Straight Root Canals with ProTaper Gold or Reciproc Blue: A Micro-Computed Tomography Study.,"BACKGROUND


The objective was to evaluate the efficiency of ProTaper Gold (PTG) and Reciproc Blue (RB) NiTi files in obturation material removal from straight root canals assessed by micro-computed tomography.
METHODS


Fifty-two anterior human teeth were shaped with a PTG rotary system until F2 (25/.08). Specimens were obturated with a continuous wave of condensation technique. For retreatment, specimens were randomly distributed in two experimental groups: PTG group (F4 file) and RB (R40 file). Micro-CT scans were performed before and after retreatment procedures. The percentage of the remaining obturation material compared to the original volume was calculated, as well as the retreatment time. The presence of separated files was recorded. A descriptive analysis was carried out, and nonparametric tests were employed.
RESULTS


The mean percentages of remaining obturation material in the PTG group and the RB group were 4.14 ± 4.30% and 4.18 ± 4.29%, respectively. The mean retreatment times for the PTG and RB groups were 144 ± 51 and 163 ± 88 s, respectively. There were no statistically significant differences, neither in removal efficiency ( p  > 0.05) nor in retreatment time ( p  > 0.05), between the two groups. The coronal and middle thirds presented significantly more remaining obturation material than the apical third ( p  < 0.05). No file separation occurred.
CONCLUSIONS


ProTaper Gold and Reciproc Blue present with comparable efficiency in removing the obturation material, with a similar mean retreatment time.",2020,The coronal and middle thirds presented significantly more remaining obturation material than the apical third ( p  < 0.05).,['Fifty-two anterior human teeth'],"['PTG group (F4 file) and RB (R40 file', 'ProTaper Gold (PTG) and Reciproc Blue (RB) NiTi files', 'Straight Root Canals with ProTaper Gold or Reciproc Blue']","['percentage of the remaining obturation material', 'remaining obturation material', 'mean percentages of remaining obturation material', 'retreatment time', 'removal efficiency']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0450439', 'cui_str': 'Obturation material'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0155847,The coronal and middle thirds presented significantly more remaining obturation material than the apical third ( p  < 0.05).,"[{'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Faus-Matoses', 'Affiliation': 'Department of Restorative Dentistry and Endodontics, Valencia University Medical and Dental School, 46010 Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Pasarín-Linares', 'Affiliation': 'Department of Restorative Dentistry and Endodontics, Valencia University Medical and Dental School, 46010 Valencia, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Faus-Matoses', 'Affiliation': 'Department of Restorative Dentistry and Endodontics, Valencia University Medical and Dental School, 46010 Valencia, Spain.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Foschi', 'Affiliation': ""Department of Endodontics, Faculty of Dentistry, Oral & Craniofacial Sciences, Floor 22 Tower Wing, Guy's Dental Hospital, London SE1 9RT, UK.""}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Sauro', 'Affiliation': 'Institute of Dentistry, I. M. Sechenov First Moscow State Medical University, 119146 Moscow, Russia.'}, {'ForeName': 'Vicente J', 'Initials': 'VJ', 'LastName': 'Faus-Llácer', 'Affiliation': 'Department of Restorative Dentistry and Endodontics, Valencia University Medical and Dental School, 46010 Valencia, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9041164']
405,32325778,"Effects of an Omega-3 and Vitamin D Supplement on Fatty Acids and Vitamin D Serum Levels in Double-Blinded, Randomized, Controlled Trials in Healthy and Crohn's Disease Populations.","Two trials separately measured the bioavailability and impact on inflammation of a supplement taken daily containing 510 mg Docosahexaenoic acid (DHA), 344 mg Eicosapentaenoic acid (EPA), and 1000 IU of vitamin D (25-hydroxyvitamin D; 25(OH)D), for healthy and Crohn's disease (CD) populations. Both trials were double blinded, randomized, placebo-controlled with cross-over. Participants were randomly allocated to groups A (placebo then supplement) or B (supplement then placebo). Both included a washout. Fatty acid ( N -3 PUFAs) and vitamin D serum levels, plasma C-reactive protein (CRP), and stool calprotectin were measured before and after each treatment period. Outcome measures were analyzed using generalized linear mixed models, including terms for treatment, period, and a treatment-by-period interaction. The supplement significantly increased serum levels in healthy and CD groups for EPA ( p  < 0.001 and  p  < 0.001, respectively), Docosapentaenoic acid ( p  < 0.001 and 0.005), DHA ( p  < 0.001 and 0.006), the omega-3 index ( p  < 0.001 and 0.001), and (vitamin D ( p  < 0.001 and 0.027). CRP and calprotectin measures showed no evidence of a treatment effect on inflammation; however, model estimation was imprecise for both outcomes, hence further research is required to elucidate potential inflammation effects. The nutrient supplement increased serum levels of key  N -3 PUFAs and vitamin D in both populations, showing the preparation was readily bioavailable.",2020,"The supplement significantly increased serum levels in healthy and CD groups for EPA ( p  < 0.001 and  p  < 0.001, respectively), Docosapentaenoic acid ( p  < 0.001 and 0.005), DHA ( p  < 0.001 and 0.006), the omega-3 index ( p  < 0.001 and 0.001), and (vitamin D ( p  < 0.001 and 0.027).","[""Healthy and Crohn's Disease Populations"", ""healthy and Crohn's disease (CD) populations""]","['Omega-3 and Vitamin D Supplement', 'Docosahexaenoic acid (DHA), 344 mg Eicosapentaenoic acid (EPA), and 1000 IU of vitamin D (25-hydroxyvitamin D; 25(OH)D', 'placebo', 'placebo then supplement) or B (supplement then placebo']","['inflammation', 'Fatty acid ( N -3 PUFAs) and vitamin D serum levels, plasma C-reactive protein (CRP), and stool calprotectin', 'Fatty Acids and Vitamin D Serum Levels', 'serum levels of key  N -3 PUFAs and vitamin D', 'Docosapentaenoic acid', 'bioavailability and impact on inflammation', 'serum levels', 'omega-3 index']","[{'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.684886,"The supplement significantly increased serum levels in healthy and CD groups for EPA ( p  < 0.001 and  p  < 0.001, respectively), Docosapentaenoic acid ( p  < 0.001 and 0.005), DHA ( p  < 0.001 and 0.006), the omega-3 index ( p  < 0.001 and 0.001), and (vitamin D ( p  < 0.001 and 0.027).","[{'ForeName': 'Bobbi', 'Initials': 'B', 'LastName': 'Brennan Laing', 'Affiliation': 'Faculty of Medical and Health Sciences, University of Auckland, Auckland 1023, New Zealand.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Cavadino', 'Affiliation': 'School of Population Health, University of Auckland, Auckland 1023, New Zealand.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Ellett', 'Affiliation': 'Faculty of Medical and Health Sciences, University of Auckland, Auckland 1023, New Zealand.'}, {'ForeName': 'Lynnette R', 'Initials': 'LR', 'LastName': 'Ferguson', 'Affiliation': 'Faculty of Medical and Health Sciences, University of Auckland, Auckland 1023, New Zealand.'}]",Nutrients,['10.3390/nu12041139']
406,32325781,Flaxseed ( Linum Usitatissimum  L.) Supplementation in Patients Undergoing Lipoprotein Apheresis for Severe Hyperlipidemia-A Pilot Study.,"Being rich in polyunsaturated fatty acids, flaxseed ( Linum usitatissimum  L.) is thought to be able to decrease lipid levels and dampen inflammation. In this pilot study, we aimed to determine whether flaxseed supplementation could improve the profiles of lipids and inflammatory mediators in patients with severe hyperlipidemia resistant to conventional lipid-lowering pharmacotherapy and requiring lipoprotein apheresis. To this end, six patients received, blindly-in addition to their normal lipoprotein apheresis regimen-a 10-week dietary supplementation with flaxseed (28 g/d) administered in biscuits. This was followed by a 10-week washed out-period and a 10-week supplementation phase with whole wheat placebo. Blood samples were collected at the end of each phase, before the lipoprotein apheresis session. The primary endpoint was the lipid profile and the secondary endpoints were the concentrations of inflammatory mediators and tolerability. Flaxseed supplementation was well-tolerated and resulted in a consistent and significant decrease in total cholesterol and low-density lipoprotein (LDL) levels. The median (and range) percentage decrease was 11.5% (0-18.8) and 7.3% (4.4-26.6), for cholesterol ( p  = 0.015) and LDL-C ( p  = 0.003), respectively. On the other hand, there was no significant effect of flaxseed on lipoprotein(a) (Lp(a)), C-reactive protein (CRP), and interleukin 6 (IL-6) concentrations. These observations indicate that flaxseed can produce a cholesterol- and LDL-lowering effect in patients treated with lipoprotein apheresis. Thus, flaxseed supplementation may help to control cholesterol in this patient population. The flaxseed supplementation protocol applied may be of use for further adequately-powered studies to validate and extend our findings.",2020,Flaxseed supplementation was well-tolerated and resulted in a consistent and significant decrease in total cholesterol and low-density lipoprotein (LDL) levels.,"['patients with severe hyperlipidemia resistant to conventional lipid-lowering pharmacotherapy and requiring lipoprotein apheresis', 'Patients Undergoing Lipoprotein Apheresis for Severe Hyperlipidemia-A Pilot Study']","['flaxseed supplementation', 'Flaxseed supplementation', 'blindly-in addition to their normal lipoprotein apheresis regimen-a 10-week dietary supplementation with flaxseed (28 g/d) administered in biscuits', 'Flaxseed ( Linum Usitatissimum  L.) Supplementation', 'placebo']","['total cholesterol and low-density lipoprotein (LDL) levels', 'concentrations of inflammatory mediators and tolerability', 'flaxseed on lipoprotein(a) (Lp(a', 'lipid levels and dampen inflammation', ' C-reactive protein (CRP), and interleukin 6 (IL-6) concentrations', 'lipid profile']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0005791', 'cui_str': 'Apheresis'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0023753', 'cui_str': 'Linum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0005791', 'cui_str': 'Apheresis'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C3164740', 'cui_str': '28 gauge'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C1095866', 'cui_str': 'Linum usitatissimum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023753', 'cui_str': 'Linum'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",,0.103819,Flaxseed supplementation was well-tolerated and resulted in a consistent and significant decrease in total cholesterol and low-density lipoprotein (LDL) levels.,"[{'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Kanikowska', 'Affiliation': 'Department of Pathophysiology, Poznan University of Medical Sciences, Rokietnicka 8, 60-806 Poznań, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Korybalska', 'Affiliation': 'Department of Pathophysiology, Poznan University of Medical Sciences, Rokietnicka 8, 60-806 Poznań, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Mickiewicz', 'Affiliation': '1st Department of Cardiology, Medical University of Gdansk, Marii Skłodowskiej-Curie 3a, 80-210 Gdańsk, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Pathophysiology, Poznan University of Medical Sciences, Rokietnicka 8, 60-806 Poznań, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Kuchta', 'Affiliation': 'Department of Clinical Chemistry, Medical University of Gdansk, Marii Skłodowskiej-Curie 3a, 80-210 Gdańsk, Poland.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Department of Physiology, School of Medicine, Institutional Research, Aichi Medical University, Nagakute, Aichi 480-1195, Japan.'}, {'ForeName': 'Ewelina', 'Initials': 'E', 'LastName': 'Kreft', 'Affiliation': 'Department of Clinical Chemistry, Medical University of Gdansk, Marii Skłodowskiej-Curie 3a, 80-210 Gdańsk, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Fijałkowski', 'Affiliation': '1st Department of Cardiology, Medical University of Gdansk, Marii Skłodowskiej-Curie 3a, 80-210 Gdańsk, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Gruchała', 'Affiliation': '1st Department of Cardiology, Medical University of Gdansk, Marii Skłodowskiej-Curie 3a, 80-210 Gdańsk, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Jankowski', 'Affiliation': 'Department of Clinical Chemistry, Medical University of Gdansk, Marii Skłodowskiej-Curie 3a, 80-210 Gdańsk, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Bręborowicz', 'Affiliation': 'Department of Pathophysiology, Poznan University of Medical Sciences, Rokietnicka 8, 60-806 Poznań, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Witowski', 'Affiliation': 'Department of Pathophysiology, Poznan University of Medical Sciences, Rokietnicka 8, 60-806 Poznań, Poland.'}]",Nutrients,['10.3390/nu12041137']
407,32325794,A Randomized Controlled Open Label Crossover Trial to Study Vaginal Colonization of Orally Administered Lactobacillus Reuteri RC-14 and Rhamnosus GR-1 in Pregnant Women at High Risk for Preterm Labor.,"Lactobacilli administration has been suggested for the treatment and prevention of bacterial vaginosis, which increases the risk for preterm birth. We aimed to evaluate the vaginal colonization of lactobacilli orally administered to pregnant women at risk for preterm birth. We performed a randomized and controlled crossover study between January 2016 and May 2017. Forty pregnant women at high risk for preterm birth with normal vaginal flora (Nugent score ≤ 3) were randomized to either receive two oral capsules/day each containing 5 × 10 9   Lactobacilli  (L.)  rhamnosus  GR-1 and  L. reuteri  RC-14 ( n  = 20) or no treatment ( n  = 20) for 2 months. Treatments were then crossed over for an additional two months. A vaginal examination and swabbing were performed for assessment of bacterial vaginosis at baseline and every month until study completion. At the same time points, vaginal samples were cultured and subjected to matrix-assisted-laser-desorption/ionization-time-of-flight-mass-spectrometry (MALDI TOF-MS) for the detection of the specific bacterial strains contained in the capsules. The primary endpoint was the presence of the administered lactobacilli strains in the vagina during the first two months of follow-up. Thirty-eight women completed the study. During the first two months of treatment,  L. rhamnosus  GR-1 was detected in one (5%) woman on the probiotic treatment and 2 (11%) women receiving no treatment ( p  = 0.6).  L. rhamnosus  GR-1 was detected in vaginal samples of 4 (11%) women during probiotic treatment (of both groups) and  L. reuteri  RC-14 was not detected in any samples. The rest of the endpoints were not different between the groups. Altogether, vaginal colonization of lactobacilli following oral administration is low during pregnancy.",2020,L. rhamnosus  GR-1 was detected in vaginal samples of 4 (11%) women during probiotic treatment (of both groups) and  L. reuteri  RC-14 was not detected in any samples.,"['Pregnant Women at High Risk for Preterm Labor', 'Forty pregnant women at high risk for preterm birth with normal vaginal flora (Nugent score ≤ 3', 'pregnant women at risk for preterm birth', 'January 2016 and May 2017', 'Thirty-eight women completed the study']","['Lactobacillus Reuteri RC-14 and Rhamnosus GR-1', 'oral capsules/day each containing 5 × 10 9   Lactobacilli  (L.)  rhamnosus  GR-1 and  L. reuteri  RC-14 ( n  = 20) or no treatment', 'Lactobacilli']",['presence of the administered lactobacilli strains in the vagina'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0991533', 'cui_str': 'Oral capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]",40.0,0.0809557,L. rhamnosus  GR-1 was detected in vaginal samples of 4 (11%) women during probiotic treatment (of both groups) and  L. reuteri  RC-14 was not detected in any samples.,"[{'ForeName': 'Enav', 'Initials': 'E', 'LastName': 'Yefet', 'Affiliation': 'Department of Obstetrics & Gynecology, Emek Medical Center, Afula 1834111, Israel.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Colodner', 'Affiliation': 'Microbiology Laboratory, Emek Medical Center, Afula 1834111, Israel.'}, {'ForeName': 'Merav', 'Initials': 'M', 'LastName': 'Strauss', 'Affiliation': 'Microbiology Laboratory, Emek Medical Center, Afula 1834111, Israel.'}, {'ForeName': 'Yifat', 'Initials': 'Y', 'LastName': 'Gam Ze Letova', 'Affiliation': 'Department of Obstetrics & Gynecology, Emek Medical Center, Afula 1834111, Israel.'}, {'ForeName': 'Zohar', 'Initials': 'Z', 'LastName': 'Nachum', 'Affiliation': 'Department of Obstetrics & Gynecology, Emek Medical Center, Afula 1834111, Israel.'}]",Nutrients,['10.3390/nu12041141']
408,32326541,Nutrition and Lifestyle Behavior Peer Support Program for Adults with Metabolic Syndrome: Outcomes and Lessons Learned from a Feasibility Trial.,"BACKGROUND


While peer support interventions have shown to benefit adults with certain chronic conditions, there is limited evidence on its feasibility and effectiveness among people with metabolic syndrome (MetS). This paper describes the outcomes of a pre-post feasibility trial of "" PE e R   SU pport program for  AD ults with m E tabolic syndrome"" (PERSUADE), an evidence-based and community-specific nutrition and lifestyle behavior peer support program for Malaysian adults with MetS.
METHODS


We recruited 48 peers (median age: 46 (IQR = 11) years old) into four peer groups, who underwent 3 months of PERSUADE, followed by 3 months of follow-up period. Statistical analyses were conducted at post-intervention and post-follow-up to assess the changes in nutrition intake, anthropometry, and metabolic parameters.
RESULTS


Although there were significant overall increases in total carbohydrate intake and glycemic load (both  p  < 0.001), we noted significant reductions in the intakes of total energy and fat (both  p  < 0.001). Physical activity (total METS/week) also showed a significant improvement ( p  < 0.001). Overall, significant but marginal improvements in anthropometric and vital metabolic parameters were also observed.
CONCLUSIONS


The feasibility trial supported the adoption of PERSUADE, though there is a need to assess the long-term impact of the peer support program in local community settings.",2020,Physical activity (total METS/week) also showed a significant improvement ( p  < 0.001).,"['Malaysian adults with MetS.\nMETHODS\n\n\nWe recruited 48 peers (median age: 46 (IQR = 11) years old', 'people with metabolic syndrome (MetS', 'Adults with Metabolic Syndrome']","[' PE e R   SU pport program', 'Nutrition and Lifestyle Behavior Peer Support Program']","['total carbohydrate intake and glycemic load', 'intakes of total energy and fat', 'Physical activity', 'anthropometric and vital metabolic parameters']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C4042927', 'cui_str': 'Glycemic Load'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",48.0,0.100651,Physical activity (total METS/week) also showed a significant improvement ( p  < 0.001).,"[{'ForeName': 'Muhammad Daniel Azlan', 'Initials': 'MDA', 'LastName': 'Mahadzir', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Jalan Lagoon Selatan, Bandar Sunway 47500, Malaysia.'}, {'ForeName': 'Kia Fatt', 'Initials': 'KF', 'LastName': 'Quek', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Jalan Lagoon Selatan, Bandar Sunway 47500, Malaysia.'}, {'ForeName': 'Amutha', 'Initials': 'A', 'LastName': 'Ramadas', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Jalan Lagoon Selatan, Bandar Sunway 47500, Malaysia.'}]",Nutrients,['10.3390/nu12041091']
409,32326621,Long-Term Effects of Vitamin D Supplementation in Obese Children During Integrated Weight-Loss Programme-A Double Blind Randomized Placebo-Controlled Trial.,"BACKGROUND


Vitamin D was studied in regards to its possible impact on body mass reduction and metabolic changes in adults and children with obesity yet there were no studies assessing the impact of vitamin D supplementation during a weight management program in children and adolescence. The aim of our study was to assess the influence of 26 weeks of vitamin D supplementation in overweight and obese children undergoing an integrated 12-months' long weight loss program on body mass reduction, body composition and bone mineral density.
METHODS


A double-blind randomized placebo-controlled trial. Vitamin D deficient patients (<30 ng/ml level of vitamin D) aged 6-14, participating in multidisciplinary weight management program were randomly allocated to receiving vitamin D (1200 IU) or placebo for the first 26 weeks of the intervention.
RESULTS


Out of the 152 qualified patients, 109 (72%) completed a full cycle of four visits scheduled in the program. There were no difference in the level of BMI (body mass index) change - both raw BMI and BMI centiles. Although the reduction of BMI centiles was greater in the vitamin D vs. placebo group (-4.28 ± 8.43 vs. -2.53 ± 6.10) the difference was not statistically significant ( p  = 0.319). Similarly the reduction in fat mass-assessed both using bioimpedance and DEXa was achieved, yet the differences between the groups were not statistically significant.
CONCLUSIONS


Our study ads substantial results to support the thesis on no effect of vitamin D supplementation on body weight reduction in children and adolescents with vitamin D insufficiency undergoing a weight management program.",2020,There were no difference in the level of BMI (body mass index) change - both raw BMI and BMI centiles.,"['Obese Children', ""overweight and obese children undergoing an integrated 12-months' long weight loss program on body mass reduction, body composition and bone mineral density"", 'adults and children with obesity', 'children and adolescents with vitamin D insufficiency undergoing a weight management program', 'deficient patients (<30 ng/ml level of vitamin D) aged 6-14, participating in multidisciplinary weight management program', '152 qualified patients, 109 (72%) completed a full cycle of four visits scheduled in the program']","['Vitamin D Supplementation', 'Placebo', 'placebo', 'vitamin D supplementation', 'Vitamin D', 'vitamin D', 'vitamin D vs. placebo']","['fat mass-assessed both using bioimpedance and DEXa', 'level of BMI (body mass index) change - both raw BMI and BMI centiles', 'BMI centiles', 'body weight reduction']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.515459,There were no difference in the level of BMI (body mass index) change - both raw BMI and BMI centiles.,"[{'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Brzeziński', 'Affiliation': 'Department of Paediatrics, Gastroenterology, Allergology and Paediatric Nutrition, Medical University of Gdańsk, 80-803 Gdańsk, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Jankowska', 'Affiliation': 'Department of Paediatrics, Gastroenterology, Allergology and Paediatric Nutrition, Medical University of Gdańsk, 80-803 Gdańsk, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Słomińska-Frączek', 'Affiliation': 'Department of Paediatrics, Copernicus Medical Center, 80-462 Gdańsk, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Metelska', 'Affiliation': 'Department of Public Health and Social Medicine, Medical University of Gdansk, 80-210 Gdańsk, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Wiśniewski', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Medical University of Gdansk, 80-952 Gdańsk, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Socha', 'Affiliation': ""Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute, 04-730 Warszawa, Poland.""}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Szlagatys-Sidorkiewicz', 'Affiliation': 'Department of Paediatrics, Gastroenterology, Allergology and Paediatric Nutrition, Medical University of Gdańsk, 80-803 Gdańsk, Poland.'}]",Nutrients,['10.3390/nu12041093']
410,32325856,Yeast Beta-Glucan Supplementation Downregulates Markers of Systemic Inflammation after Heated Treadmill Exercise.,"Aerobic exercise and thermal stress instigate robust challenges to the immune system. Various attempts to modify or supplement the diet have been proposed to bolster the immune system responses. The purpose of this study was to identify the impact of yeast beta-glucan ( Saccharomyces cerevisiae ) supplementation on exercise-induced muscle damage and inflammation. Healthy, active men (29.6 ± 6.7 years, 178.1 ± 7.2 cm, 83.2 ± 11.2 kg, 49.6 ± 5.1 mL/kg/min,  n  = 16) and women (30.1 ± 8.9 years, 165.6 ± 4.1 cm, 66.7 ± 10.0 kg, 38.7 ± 5.8 mL/kg/min,  n  = 15) were randomly assigned in a double-blind and cross-over fashion to supplement for 13 days with either 250 mg/day of yeast beta-glucan (YBG) or a maltodextrin placebo (PLA). Participants arrived fasted and completed a bout of treadmill exercise at 55% peak aerobic capacity (VO 2Peak ) in a hot (37.2 ± 1.8 °C) and humid (45.2 ± 8.8%) environment. Prior to and 0, 2, and 72 h after completing exercise, changes in white blood cell counts, pro- and anti-inflammatory cytokines, markers of muscle damage, markers of muscle function, soreness, and profile of mood states (POMS) were assessed. In response to exercise and heat, both groups experienced significant increases in white blood cell counts, plasma creatine kinase and myoglobin, and soreness along with reductions in peak torque and total work with no between-group differences. Concentrations of serum pro-inflammatory cytokines in YBG were lower than PLA for macrophage inflammatory protein 1β (MIP-1β) ( p  = 0.044) and tended to be lower for interleukin 8 (IL-8) ( p  = 0.079), monocyte chemoattractment protein 1 (MCP-1) ( p  = 0.095), and tumor necrosis factor α (TNF-α) ( p  = 0.085). Paired samples  t -tests using delta values between baseline and 72 h post-exercise revealed significant differences between groups for IL-8 ( p  = 0.044, 95% Confidence Interval (CI): (0.013, 0.938,  d  = -0.34), MCP-1 ( p  = 0.038, 95% CI: 0.087, 2.942,  d  = -0.33), and MIP-1β ( p  = 0.010, 95% CI: 0.13, 0.85,  d  = -0.33). POMS outcomes changed across time with anger scores in PLA exhibiting a sharper decline than YBG ( p  = 0.04). Vigor scores ( p  = 0.04) in YBG remained stable while scores in PLA were significantly reduced 72 h after exercise. In conclusion, a 13-day prophylactic period of supplementation with 250 mg of yeast-derived beta-glucans invoked favorable changes in cytokine markers of inflammation after completing a prolonged bout of heated treadmill exercise.",2020,"In response to exercise and heat, both groups experienced significant increases in white blood cell counts, plasma creatine kinase and myoglobin, and soreness along with reductions in peak torque and total work with no between-group differences.","['Healthy, active men (29.6 ± 6.7 years, 178.1 ± 7.2 cm, 83.2 ± 11.2 kg, 49.6 ± 5.1 mL/kg/min,  n  = 16) and women (30.1 ± 8.9 years, 165.6 ± 4.1 cm, 66.7 ± 10.0 kg, 38.7 ± 5.8 mL/kg/min,  n  = 15']","['double-blind and cross-over fashion to supplement for 13 days with either 250 mg/day of yeast beta-glucan (YBG) or a maltodextrin placebo (PLA', 'Aerobic exercise', 'yeast beta-glucan ( Saccharomyces cerevisiae ) supplementation', 'bout of treadmill exercise at 55% peak aerobic capacity (VO 2Peak ']","['monocyte chemoattractment protein 1 (MCP-1', 'IL-8 ', 'cytokine markers of inflammation', 'peak torque and total work', 'white blood cell counts, pro- and anti-inflammatory cytokines, markers of muscle damage, markers of muscle function, soreness, and profile of mood states (POMS', 'tumor necrosis factor α (TNF-α', 'white blood cell counts, plasma creatine kinase and myoglobin, and soreness', 'Concentrations of serum pro-inflammatory cytokines in YBG', 'Vigor scores', 'MCP-1']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C4517796', 'cui_str': '5.8'}]","[{'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C1134651', 'cui_str': 'Beta glucan'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]","[{'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",15.0,0.294643,"In response to exercise and heat, both groups experienced significant increases in white blood cell counts, plasma creatine kinase and myoglobin, and soreness along with reductions in peak torque and total work with no between-group differences.","[{'ForeName': 'Hannah A', 'Initials': 'HA', 'LastName': 'Zabriskie', 'Affiliation': 'Department of Kinesiology, Towson University, Towson, MD 21252, USA.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Blumkaitis', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, 209 S. Kingshighway, St. Charles, MO 63301, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Moon', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, 209 S. Kingshighway, St. Charles, MO 63301, USA.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Currier', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, 209 S. Kingshighway, St. Charles, MO 63301, USA.'}, {'ForeName': 'Riley', 'Initials': 'R', 'LastName': 'Stefan', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, 209 S. Kingshighway, St. Charles, MO 63301, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Ratliff', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, 209 S. Kingshighway, St. Charles, MO 63301, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Harty', 'Affiliation': 'Energy Balance and Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX 79409, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Stecker', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, 209 S. Kingshighway, St. Charles, MO 63301, USA.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Rudnicka', 'Affiliation': 'Department of Immunology and Infectious Biology, Faculty of Biology and Environmental Protection, University of Lodz, 90-136 Lodz, Poland.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Jäger', 'Affiliation': 'Increnovo LLC, Milwaukee, WI 53202, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roberts', 'Affiliation': 'School of Kinesiology, Auburn University, Auburn, AL 36849, USA.'}, {'ForeName': 'Kaelin', 'Initials': 'K', 'LastName': 'Young', 'Affiliation': 'Department of Cell Biology and Physiology, Edward Via College of Osteopathic Medicine, Auburn University, Auburn, AL 36849, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Jagim', 'Affiliation': 'Sports Medicine, Mayo Clinic Health System, Onalaska, WI 54650, USA.'}, {'ForeName': 'Chad M', 'Initials': 'CM', 'LastName': 'Kerksick', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, 209 S. Kingshighway, St. Charles, MO 63301, USA.'}]",Nutrients,['10.3390/nu12041144']
411,32325914,Anserine Reverses Exercise-Induced Oxidative Stress and Preserves Cellular Homeostasis in Healthy Men.,"The study tested whether anserine (beta-alanyl-3-methyl-l-histidine), the active ingredient of chicken essence affects exercise-induced oxidative stress, cell integrity, and haematology biomarkers. In a randomized placebo-controlled repeated-measures design, ten healthy men ingested anserine in either a low dose (ANS-LD) 15 mg.kg -1 .bw -1 , high dose (ANS-HD) 30 mg.kg -1 .bw -1 , or placebo (PLA), following an exercise challenge (time to exhaustion), on three separate occasions. Anserine supplementation increased superoxide dismutase (SOD) by 50% ( p  < 0.001, effect size d = 0.8 for both ANS-LD and ANS-HD), and preserved catalase (CAT) activity suggesting an improved antioxidant activity. However, both ANS-LD and ANS-HD elevated glutathione disulfide (GSSG), (both  p  < 0.001, main treatment effect), and consequently lowered the glutathione to glutathione disulfide (GSH/GSSG) ratio compared with PLA ( p  < 0.01, main treatment effect), without significant effects on thiobarbituric acid active reactive substances (TBARS). Exercise-induced cell damage biomarkers of glutamic-oxaloacetic transaminase (GOT) and myoglobin were unaffected by anserine. There were slight but significant elevations in glutamate pyruvate transaminase (GPT) and creatine kinase isoenzyme (CKMB), especially in ANS-HD ( p  < 0.05) compared with ANS-LD or PLA. Haematological biomarkers were largely unaffected by anserine, its dose, and without interaction with post exercise time-course. However, compared with ANS-LD and PLA, ANS-HD increased the mean cell volume (MCV), and decreased the mean corpuscular haemoglobin concentration (MCHC) ( p  < 0.001). Anserine preserves cellular homoeostasis through enhanced antioxidant activity and protects cell integrity in healthy men, which is important for chronic disease prevention. However, anserine temporal elevated exercise-induced cell-damage, together with enhanced antioxidant activity and haematological responses suggest an augmented exercise-induced adaptative response and recovery.",2020,"Anserine supplementation increased superoxide dismutase (SOD) by 50% ( p  < 0.001, effect size d = 0.8 for both ANS-LD and ANS-HD), and preserved catalase (CAT) activity suggesting an improved antioxidant activity.","['healthy men', 'ten healthy men ingested anserine in either a low dose (ANS-LD', 'Healthy Men']","['placebo', 'anserine (beta-alanyl-3-methyl-l-histidine', 'placebo (PLA']","['Haematological biomarkers', 'oxidative stress, cell integrity, and haematology biomarkers', 'mean corpuscular haemoglobin concentration (MCHC', 'superoxide dismutase (SOD', 'thiobarbituric acid active reactive substances (TBARS', 'preserved catalase (CAT) activity', 'mean cell volume (MCV', 'glutathione disulfide (GSSG', 'antioxidant activity and haematological responses', 'Exercise-induced cell damage biomarkers of glutamic-oxaloacetic transaminase (GOT) and myoglobin', 'glutamate pyruvate transaminase (GPT) and creatine kinase isoenzyme (CKMB), especially in ANS-HD', 'glutathione to glutathione disulfide (GSH/GSSG) ratio', 'antioxidant activity']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0003134', 'cui_str': 'Anserine'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003134', 'cui_str': 'Anserine'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1274119', 'cui_str': 'Hematopathology'}, {'cui': 'C0369183', 'cui_str': 'Mean corpuscular hemoglobin determination'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0474535', 'cui_str': 'Mean corpuscular hemoglobin concentration determination'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0076442', 'cui_str': 'thiobarbituric acid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0524587', 'cui_str': 'Mean cell volume - finding'}, {'cui': 'C0026394', 'cui_str': 'Molluscum contagiosum virus'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0010288', 'cui_str': 'Creatine kinase isoenzyme'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",10.0,0.103446,"Anserine supplementation increased superoxide dismutase (SOD) by 50% ( p  < 0.001, effect size d = 0.8 for both ANS-LD and ANS-HD), and preserved catalase (CAT) activity suggesting an improved antioxidant activity.","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alkhatib', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, No.101, Sec. 2, Zhongcheng Road., Shilin District, Taipei City 11153, Taiwan.'}, {'ForeName': 'Wen-Hsin', 'Initials': 'WH', 'LastName': 'Feng', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, No.101, Sec. 2, Zhongcheng Road., Shilin District, Taipei City 11153, Taiwan.'}, {'ForeName': 'Yi-Jen', 'Initials': 'YJ', 'LastName': 'Huang', 'Affiliation': 'Office of Physical Education, Soochow University, No. 70, Linhsi Road, Shihlin District, Taipei City 11111, Taiwan.'}, {'ForeName': 'Chia-Hua', 'Initials': 'CH', 'LastName': 'Kuo', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, No.101, Sec. 2, Zhongcheng Road., Shilin District, Taipei City 11153, Taiwan.'}, {'ForeName': 'Chien-Wen', 'Initials': 'CW', 'LastName': 'Hou', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, No.101, Sec. 2, Zhongcheng Road., Shilin District, Taipei City 11153, Taiwan.'}]",Nutrients,['10.3390/nu12041146']
412,32325919,Decreased Consumption of Added Fructose Reduces Waist Circumference and Blood Glucose Concentration in Patients with Overweight and Obesity. The DISFRUTE Study: A Randomised Trial in Primary Care.,"The relationship between fructose intake and insulin resistance remains controversial. Our purpose was to determine whether a reduction in dietary fructose is effective in decreasing insulin resistance (HOMA2-IR). This field trial was conducted on 438 adults with overweight and obese status, without diabetes. A total of 121 patients in a low fructose diet (LFD) group and 118 in a standard diet (SD) group completed the 24-week study. Both diets were prescribed with 30-40% of energy intake restriction. There were no between-group differences in HOMA2-IR. However, larger decreases were seen in the LFD group in waist circumference (-7.0 vs. -4.8 = -2.2 cms, 95% CI: -3.7, -0.7) and fasting blood glucose -0.25 vs. -0.11 = -0.14 mmol/L, 95% CI: -0.028, -0.02). The percentage of reduction in calorie intake was similar. Only were differences observed in the % energy intake for some nutrients: total fructose (-2 vs. -0.6 = -1.4, 95% CI: -2.6, -0.3), MUFA (-1.7 vs. -0.4 = -1.3, 95% CI: -2.4, -0.2), protein (5.1 vs. 3.6 = 1.4, 95% CI: 0.1, 2.7). The decrease in fructose consumption originated mainly from the reduction in added fructose (-2.8 vs. -1.9 = -0.9, 95% CI: -1.6, -0.03). These results were corroborated after multivariate adjustments. The low fructose diet did not reduce insulin resistance. However, it reduced waist circumference and fasting blood glucose concentration, which suggests a decrease in hepatic insulin resistance.",2020,There were no between-group differences in HOMA2-IR.,"['121 patients in a low fructose diet (LFD) group and 118 in a standard diet (SD) group completed the 24-week study', 'Patients with Overweight and Obesity', '438 adults with overweight and obese status, without diabetes']",['LFD'],"['HOMA2-IR', 'insulin resistance', 'calorie intake', 'MUFA', 'hepatic insulin resistance', 'insulin resistance (HOMA2-IR', 'energy intake for some nutrients: total fructose', 'waist circumference and fasting blood glucose concentration', 'waist circumference', 'fructose consumption', 'Decreased Consumption of Added Fructose Reduces Waist Circumference and Blood Glucose Concentration', 'fasting blood glucose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0452314', 'cui_str': 'Low fructose diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",[],"[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}]",438.0,0.0862863,There were no between-group differences in HOMA2-IR.,"[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Domínguez-Coello', 'Affiliation': 'Centro de Salud La Victoria de Acentejo-Tenerife, Calle Domingo Salazar 21, 38380 Tenerife, Canary Islands, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Carrillo-Fernández', 'Affiliation': 'Centro de Salud La Victoria de Acentejo, 38380 Tenerife, Canary Islands, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Gobierno-Hernández', 'Affiliation': 'Centro de Salud de Güimar 38500Tenerife, Canary Islands, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Méndez-Abad', 'Affiliation': 'Centro de Salud de la Orotava San Antonio, 38313 Tenerife, Canary Islands, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Borges-Álamo', 'Affiliation': 'Centro de Salud Ruiz de Padrón, 38002 Tenerife, Canary Islands, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'García-Dopico', 'Affiliation': 'Laboratorio del Complejo Hospitalario Universitario de Canarias, 38320 La Laguna, Canary Islands, Spain.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Aguirre-Jaime', 'Affiliation': 'Health Care Research Institute of the Santa Cruz de Tenerife College of Nursing, Colegio Oficial de Enfermeros de Santa Cruz de Tenerife, 38001 Tenerife, Spain.'}, {'ForeName': 'Antonio Cabrera-de', 'Initials': 'AC', 'LastName': 'León', 'Affiliation': 'Unidad de Investigación de la Gerencia de Atención Primaria de Tenerife y del Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, 38010 Tenerife, Canary Islands, Spain.'}]",Nutrients,['10.3390/nu12041149']
413,32229541,Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial.,"RATIONALE


Pulmonary rehabilitation (PR) is an effective, key standard treatment for people with COPD. Nevertheless, low participant uptake, insufficient attendance and high drop-out rates are reported. Investigation is warranted of the benefits achieved through alternative approaches, such as pulmonary tele-rehabilitation (PTR).
OBJECTIVE


To investigate whether PTR is superior to conventional PR on 6 min walk distance (6MWD) and secondarily on respiratory symptoms, quality of life, physical activity and lower limb muscle function in patients with COPD and FEV 1  <50% eligible for routine hospital-based, outpatient PR.
METHODS


In this single-blinded, multicentre, superiority randomised controlled trial, patients were assigned 1:1 to 10 weeks of groups-based PTR (60 min, three times weekly) or conventional PR (90 min, two times weekly). Assessments were performed by blinded assessors at baseline, end of intervention and at 22 weeks' follow-up from baseline. The primary analysis was based on the intention-to-treat principle.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was change in 6MWD from baseline to 10 weeks; 134 participants (74 females, mean±SD age 68±9 years, FEV 1  33%±9% predicted, 6MWD 327±103 metres) were included and randomised. The analysis showed no between-group differences for changes in 6MWD after intervention (9.2 metres (95% CI: -6.6 to 24.9)) or at 22 weeks' follow-up (-5.3 metres (95% CI: -28.9 to 18.3)). More participants completed the PTR intervention (n=57) than conventional PR (n=43) (χ 2  test p<0.01).
CONCLUSION


PTR was not superior to conventional PR on the 6MWD and we found no differences between groups. As more participants completed PTR, supervised PTR would be relevant to compare with conventional PR in a non-inferiority design.  Trial registration number  ClinicalTrials.gov (NCT02667171), 28 January 2016.",2020,PTR was not superior to conventional PR on the 6MWD and we found no differences between groups.,"['134 participants (74 females, mean±SD\u2009age 68±9 years, FEV 1  33%±9% predicted, 6MWD 327±103 metres', 'severe COPD', 'people with COPD', 'patients with COPD and FEV 1  <50% eligible for routine hospital-based, outpatient PR']","['PTR intervention', 'conventional PR', 'Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation', 'PTR']","['change in 6MWD', 'respiratory symptoms, quality of life, physical activity and lower limb muscle function', '6MWD']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0034380'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}]",,0.234033,PTR was not superior to conventional PR on the 6MWD and we found no differences between groups.,"[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hansen', 'Affiliation': 'Respiratory Research Unit, Department of Respiratory Medicine, Hvidovre Hospital, Hvidovre, Denmark henrik.hansen.09@regionh.dk.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Bieler', 'Affiliation': 'Department of Physical and Occupational Therapy, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Beyer', 'Affiliation': 'Institute for Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'Clinical Research Center, Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Jon Torgny', 'Initials': 'JT', 'LastName': 'Wilcke', 'Affiliation': 'Department of Pulmonary Medicine, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Lisbeth Marie', 'Initials': 'LM', 'LastName': 'Østergaard', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Frost Andeassen', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Martinez', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lavesen', 'Affiliation': 'Department of Respiratory Medicine and Infectious Diseases, Hillerød Hospital, Hillerød, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Frølich', 'Affiliation': 'Department of Public Health, University of Copenhagen Faculty of Health Sciences, Copenhagen, Denmark.'}, {'ForeName': 'Nina Skavlan', 'Initials': 'NS', 'LastName': 'Godtfredsen', 'Affiliation': 'Institute for Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.'}]",Thorax,['10.1136/thoraxjnl-2019-214246']
414,31728664,"A multicenter, double-blind, randomized trial on the bleeding profile of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg.","PURPOSE


A typical compliance problem in the use of traditional progestin-only pills is the irregular bleeding pattern and the strict daily intake. Desogestrel 75 mg has a 12-h missed-pill window; however, its poor cycle control limits a more common use.
METHODS


A drospirenone (DRSP)-only pill was developed to improve the bleeding profile.
SETTING


A phase III study in healthy women aged 18-45 years was performed to compare the bleeding profile and safety of a DRSP-only pill in a regime of 24 days of 4 mg of DRSP tablets followed by 4 days of placebo versus desogestrel 0.075 mg per day continuously over nine cycles.
POPULATION


A total of 858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed.
MAIN OUTCOME MEASURES


The primary end point was the proportion of women with unscheduled bleeding/spotting in each cycle from cycles 2 to 9 and cumulative in cycles 2-4 and cycles 7-9.
RESULTS


In each cycle, up to cycle 7, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, Chi-square test).
CONCLUSIONS


This report describes the improvement in bleeding profile of women using the new DRSP-only oral contraceptive in comparison to DSG, providing a better quality of live and adherence to the contraceptive method. EudraCT Registration Number: 2011-002396-42.",2019,"In each cycle, up to cycle 7, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, Chi-square test).
","['healthy women aged 18-45\xa0years', '858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed']","['DRSP-only pill', 'DRSP', 'desogestrel 0.075\xa0mg', 'DRSP tablets', 'traditional progestin-only pills', 'Desogestrel', 'placebo versus desogestrel', 'drospirenone']","['bleeding profile and safety', 'bleeding profile', 'proportion of women with unscheduled bleeding/spotting', 'proportion of women with unscheduled bleeding']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C1306692', 'cui_str': 'Desogestrel 0.075 MG'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",858.0,0.145873,"In each cycle, up to cycle 7, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, Chi-square test).
","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Palacios', 'Affiliation': 'Instituto Palacios, Salud y Medicina de la Mujer, C/ Antonio Acuña, 9, 28009, Madrid, Spain.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis HealthCare Madrid, C/ Manuel Pombo Angulo 28, 4th Floor, 28050, Madrid, Spain.'}, {'ForeName': 'Pedro-Antonio', 'Initials': 'PA', 'LastName': 'Regidor', 'Affiliation': 'Exeltis Europe, Adalperostr. 84, 85737, Ismaning, Germany. pedro-antonio.regidor@exeltis.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05340-4']
415,31971139,Treatment of Sick Children Seeking Care in the Private Health Sector in Uganda: A Cluster Randomized Trial.,"The main objective of this study was to assess whether training of private health providers and community sensitization on the importance of effective prompt care seeking and the need for referral could improve treatment of sick children in the private health sector in Uganda. Private providers were trained to diagnose and treat sick children according to the integrated community case management (iCCM) guidelines. In the control arm, routine services were offered. The outcomes were seeking care within 24 hours of onset of symptoms and appropriate case management for malaria, pneumonia, and diarrhea among children aged < 5 years. A total of 10,809 sick children (5,955 in the intervention arm and 4,854 in the control arm) presented for diagnosis and treatment. The percentage seeking care within 24 hours of onset of symptoms was 45.4% (95% CI 36.0-48.8) in the intervention arm versus 43.9% (95% CI 38.1-49.8) in the control arm ( P  = 0.04). Adherence to malaria rapid diagnostic test (mRDT) results was high, with 1,459 (94.3%) in the intervention arm versus 1,402 (83.0%) in the control arm ( P  = 0.04). Appropriate treatment of mRDT-positive children with artemisinin-based combination therapy was seen in 93.1% (95% CI 88.5-97.7) in the intervention arm versus 85.1% (95% CI 78.6-91.7) in the control arm ( P  = 0.03). Adherence to iCCM guidelines was very high: 89.1% of children with diarrhea in the intervention arm and 80.4% in the control arm were given oral rehydration salts and zinc ( P  = 0.01). Of the children with a respiratory rate > 40 breaths/minute, 1,596 (85.1%) in the intervention arm versus 104 (54.5%) in the control arm were given amoxicillin ( P  = 0.01). In conclusion, the intervention improved treatment of malaria, pneumonia, and diarrhea because of provider adherence to treatment guidelines. The policy implications of these findings are to initiate a dialogue at district and national levels on how to scale up the intervention in the private sector. NCT02450630 registered with ClinicalTrials.gov: May 9, 2015.",2020,Adherence to iCCM guidelines was very high: 89.1% of children with diarrhea in the intervention arm and 80.4% in the control arm were given oral rehydration salts and zinc (,"['10,809 sick children (5,955 in the intervention arm and 4,854 in the control arm) presented for diagnosis and treatment', 'sick children in the private health sector in Uganda', 'Sick Children Seeking Care in the Private Health Sector in Uganda', 'children aged < 5 years']","['oral rehydration salts and zinc ', 'amoxicillin ']","['diarrhea', 'percentage seeking care', 'malaria, pneumonia, and diarrhea', 'malaria, pneumonia, and diarrhea because of provider adherence']","[{'cui': 'C0260101', 'cui_str': 'Sick child'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0086904', 'cui_str': 'Oral Rehydration'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",10809.0,0.0716126,Adherence to iCCM guidelines was very high: 89.1% of children with diarrhea in the intervention arm and 80.4% in the control arm were given oral rehydration salts and zinc (,"[{'ForeName': 'Anthony K', 'Initials': 'AK', 'LastName': 'Mbonye', 'Affiliation': 'School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Buregyeya', 'Affiliation': 'Department of Disease Control and Environmental Health, School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Elizeus', 'Initials': 'E', 'LastName': 'Rutebemberwa', 'Affiliation': 'Department of Health Policy, Planning and Management, School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Sham', 'Initials': 'S', 'LastName': 'Lal', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Siân E', 'Initials': 'SE', 'LastName': 'Clarke', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Kristian S', 'Initials': 'KS', 'LastName': 'Hansen', 'Affiliation': 'Department of Public Health and Centre for Health Economics and Policy, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Magnussen', 'Affiliation': 'Institute for Immunology and Microbiology, Centre for Medical Parasitology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'LaRussa', 'Affiliation': 'Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, New York.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0367']
416,31643041,Effect of Simvastatin on Permeability in Cerebral Cavernous Malformation Type 1 Patients: Results from a Pilot Small Randomized Controlled Clinical Trial.,,2020,,['Cerebral Cavernous Malformation Type 1 Patients'],['Simvastatin'],[],"[{'cui': 'C2919945', 'cui_str': 'Familial Cavernous Malformation'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}]",[],,0.177976,,"[{'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Mabray', 'Affiliation': 'Department of Radiology, University of New Mexico Health Sciences Center, University of New Mexico, MSC 10 5530, 1 University of New Mexico, Albuquerque, NM, 87131, USA. mamabray@salud.unm.edu.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Caprihan', 'Affiliation': 'Mind Research Network, Albuquerque, NM, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'Department of Anesthesia and Perioperative Care, Center for Cerebrovascular Research, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'McCulloch', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Zafar', 'Affiliation': 'Department of Neurology, University of New Mexico Health Sciences Center, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesia and Perioperative Care, Center for Cerebrovascular Research, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Blaine L', 'Initials': 'BL', 'LastName': 'Hart', 'Affiliation': 'Department of Radiology, University of New Mexico Health Sciences Center, University of New Mexico, MSC 10 5530, 1 University of New Mexico, Albuquerque, NM, 87131, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': 'Department of Neurology, University of New Mexico Health Sciences Center, University of New Mexico, Albuquerque, NM, USA.'}]",Translational stroke research,['10.1007/s12975-019-00737-4']
417,32034074,Results of the ADAPT Phase 3 Study of Rocapuldencel-T in Combination with Sunitinib as First-Line Therapy in Patients with Metastatic Renal Cell Carcinoma.,"PURPOSE


Rocapuldencel-T is an autologous immunotherapy prepared from mature monocyte-derived dendritic cells (DC), coelectroporated with amplified tumor RNA plus CD40L RNA. This pivotal phase III trial was initiated to investigate the safety and efficacy of a combination therapy dosing regimen of Rocapuldencel-T plus sunitinib in patients with metastatic renal cell carcinoma (mRCC).
PATIENTS AND METHODS


Patients received either Rocapuldencel-T plus standard of care (SOC) or SOC treatment alone. The primary objective compared overall survival (OS) between groups. Secondary objectives included safety assessments, progression-free survival (PFS), and tumor responses based on RECIST 1.1 criteria. Exploratory analyses included immunologic assessments and correlates with OS.
RESULTS


Between 2013 and 2016, 462 patients were randomized 2:1, 307 to the combination group and 155 to the SOC group. Median OS in the combination group was 27.7 months [95% confidence interval (CI) 23.0-35.9] and 32.4 months (95% CI, 22.5-) in the SOC group HR of 1.10 (95% CI, 0.83-1.40). PFS was 6.0 months and 7.83 months for the combination and SOC groups, respectively [HR = 1.15 (95% CI, 0.92-1.44)]. The ORR was 42.7% (95% CI, 37.1-48.4) for the combination group and 39.4% (95% CI, 31.6-47.5) for the SOC group. Median follow up was 29 months (0.4-47.7 months). On the basis of the lack of clinical efficacy, the ADAPT trial was terminated on February 17, 2017. Immune responses were detected in 70% of patients treated with Rocapuldencel-T, and the magnitude of the immune response positively correlated with OS. In addition, we report the survival-predictive value of measuring IL-12 produced by the DC vaccine and the observation that high baseline numbers of T regulatory cells are associated with improved outcomes in DC-treated patients, but are associated with poor outcomes in patients receiving SOC treatment. No serious adverse events attributed to the study medication have been reported to date.
CONCLUSIONS


Rocapuldencel-T did not improve OS in patients treated with combination therapy, although the induced immune response correlated with OS. Moreover, we identified two potential survival-predictive biomarkers for patients receiving DC based immunotherapy, IL-12 produced by the DC vaccine and higher numbers of T regulatory cells present in the peripheral blood of patients with advanced RCC.",2020,"Rocapuldencel-T did not improve OS in patients treated with combination therapy, although the immune response correlated with OS.","['patients with mRCC', '462 patients were randomized 2:1, 307 to the combination group and 155 to the SOC group', 'patients with metastatic renal cell carcinoma']","['Rocapuldencel-T plus SOC or SOC treatment alone', 'sunitinib', 'Rocapuldencel-T plus sunitinib']","['PFS', 'Immune responses', 'survival-predictive value of IL-12', 'safety and efficacy', 'Median OS', 'ORR', 'safety, PFS and tumor responses', 'immunological assessments and correlates with OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",462.0,0.143527,"Rocapuldencel-T did not improve OS in patients treated with combination therapy, although the immune response correlated with OS.","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Figlin', 'Affiliation': 'Cedars-Sinai Medical Center Los Angeles, California.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'University of Texas, MD Anderson Cancer Center Houston, Texas.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Uzzo', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System, Philadelphia, Pennsylvania.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Tykodi', 'Affiliation': 'Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington.'}, {'ForeName': 'David Y T', 'Initials': 'DYT', 'LastName': 'Chen', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System, Philadelphia, Pennsylvania.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Master', 'Affiliation': 'Emory University Department of Urology, Emory University Hospital, Atlanta, Georgia.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'Urologic Cancer Centre for Research and Innovation, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vaena', 'Affiliation': 'Holden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lowrance', 'Affiliation': 'Huntsman Cancer Hospital, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Gennady', 'Initials': 'G', 'LastName': 'Bratslavsky', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'DeBenedette', 'Affiliation': 'Argos Therapeutics Inc., now CoImmune Inc., Durham, North Carolina. mdebenedette@coimmune.com.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Gamble', 'Affiliation': 'Argos Therapeutics Inc., now CoImmune Inc., Durham, North Carolina.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Plachco', 'Affiliation': 'Argos Therapeutics Inc., now CoImmune Inc., Durham, North Carolina.'}, {'ForeName': 'Marcus S', 'Initials': 'MS', 'LastName': 'Norris', 'Affiliation': 'Argos Therapeutics Inc., now CoImmune Inc., Durham, North Carolina.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Horvatinovich', 'Affiliation': 'Argos Therapeutics Inc., now CoImmune Inc., Durham, North Carolina.'}, {'ForeName': 'Irina Y', 'Initials': 'IY', 'LastName': 'Tcherepanova', 'Affiliation': 'Argos Therapeutics Inc., now CoImmune Inc., Durham, North Carolina.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nicolette', 'Affiliation': 'Argos Therapeutics Inc., now CoImmune Inc., Durham, North Carolina.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Wood', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2427']
418,32293191,Mid-position treatment strategy for locally advanced lung cancer: a dosimetric study.,"OBJECTIVE


The internal target volume (ITV) strategy generates larger planning target volumes (PTVs) in locally advanced non-small cell lung cancer (LA-NSCLC) than the Mid-position (Mid-p) strategy. We investigated the benefit of the Mid-p strategy regarding PTV reduction and dose to the organs at risk (OARs).
METHODS


44 patients with LA-NSCLC were included in a randomized clinical study to compare ITV and Mid-p strategies. GTV were delineated by a physician on maximum intensity projection images and on Mid-p images from four-dimensional CTs. CTVs were obtained by adding 6 mm uniform margin for microscopic extension. CTV to PTV margins were calculated using the van Herk's recipe for setup and delineation errors. For the Mid-p strategy, the mean target motion amplitude was added as a random error. For both strategies, three-dimensional conformal plans delivering 60-66 Gy to PTV were performed. PTVs, dose-volume parameters for OARs (lung, esophagus, heart, spinal cord) were reported and compared.
RESULTS


With the Mid-p strategy, the median of volume reduction was 23.5 cm 3  ( p  = 0.012) and 8.8 cm 3  ( p  = 0.0083) for PTV T  and PTV N  respectively; the median mean lung dose reduction was 0.51 Gy ( p  = 0.0057). For 37.1% of the patients, delineation errors led to smaller PTV with the ITV strategy than with the Mid-p strategy.
CONCLUSION


PTV and mean lung dose were significantly reduced using the Mid-p strategy. Delineation uncertainty can unfavorably impact the advantage.
ADVANCES IN KNOWLEDGE


To the best of our knowledge, this is the first dosimetric comparison study between ITV and Mid-p strategies for LA-NSCLC.",2020,"For 37.1% of the patients, delineation errors led to smaller PTV with the ITV strategy than with the Mid-p strategy.
","['44 patients with LA-NSCLC', 'locally advanced lung cancer']","['Mid-position treatment strategy', 'internal target volume (ITV) strategy generates larger planning target volumes (PTVs']","['mean target motion amplitude', 'median of volume reduction', 'PTVs, dose-volume parameters for OARs (lung, esophagus, heart, spinal cord']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}]","[{'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0454199', 'cui_str': 'Planning target volume'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2936599', 'cui_str': 'Organs at Risk'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}]",44.0,0.0337473,"For 37.1% of the patients, delineation errors led to smaller PTV with the ITV strategy than with the Mid-p strategy.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ayadi', 'Affiliation': 'Radiotherapy and Physics Department, Leon Berard Cancer Center, 28, rue Laennec F-69373, Lyon, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Baudier', 'Affiliation': 'Univ Lyon, INSA-Lyon, Université Lyon 1, CNRS, Inserm, Centre Léon Bérard, CREATIS UMR 5220, U1206, F-69373, Lyon, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bouilhol', 'Affiliation': 'Department of Radiotherapy, Hartmann Radiotherapy Center, American Hospital of Paris, Neuilly, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Dupuis', 'Affiliation': 'Radiotherapy and Physics Department, Leon Berard Cancer Center, 28, rue Laennec F-69373, Lyon, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Boissard', 'Affiliation': 'Radiotherapy and Physics Department, Leon Berard Cancer Center, 28, rue Laennec F-69373, Lyon, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pinho', 'Affiliation': 'Univ Lyon, INSA-Lyon, Université Lyon 1, CNRS, Inserm, Centre Léon Bérard, CREATIS UMR 5220, U1206, F-69373, Lyon, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Krason', 'Affiliation': 'Univ Lyon, INSA-Lyon, Université Lyon 1, CNRS, Inserm, Centre Léon Bérard, CREATIS UMR 5220, U1206, F-69373, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rit', 'Affiliation': 'Univ Lyon, INSA-Lyon, Université Lyon 1, CNRS, Inserm, Centre Léon Bérard, CREATIS UMR 5220, U1206, F-69373, Lyon, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Claude', 'Affiliation': 'Radiotherapy and Physics Department, Leon Berard Cancer Center, 28, rue Laennec F-69373, Lyon, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sarrut', 'Affiliation': 'Univ Lyon, INSA-Lyon, Université Lyon 1, CNRS, Inserm, Centre Léon Bérard, CREATIS UMR 5220, U1206, F-69373, Lyon, France.'}]",The British journal of radiology,['10.1259/bjr.20190692']
419,30997482,Sex-Related Differences in Brain Volumes and Cerebral Blood Flow Among Overweight and Obese Adults With Type 2 Diabetes: Exploratory Analyses From the Action for Health in Diabetes Brain Magnetic Resonance Imaging Study.,"BACKGROUND


Sex may be an important modifier of brain health in response to risk factors. We compared brain structure and function of older overweight and obese women and men with type 2 diabetes mellitus.
METHODS


Cross-sectional cognitive assessments and magnetic resonance images were obtained in 224 women and 95 men (mean age 69 years) with histories of type 2 diabetes mellitus and overweight or obesity. Prior to magnetic resonance images, participants had completed an average of 10 years of random assignment to either multidomain intervention targeting weight loss or a control condition of diabetes support and education. Total (summed gray and white) matter volumes, white matter hyperintensity volumes, and cerebral blood flow across five brain regions of interest were analyzed using mixed-effects models.
RESULTS


After covariate adjustment, women, compared with men, averaged 10.9 [95% confidence interval 3.3, 18.5; ≈1%] cc greater summed region of interest volumes and 1.39 [0.00002, 2.78; ≈54%] cc greater summed white matter hyperintensity volumes. Sex differences could not be attributed to risk factor profiles or intervention response. Their magnitude did not vary significantly with respect to age, body mass index, intervention assignment, or APOE-ε4 genotype. Sex differences in brain magnetic resonance images outcomes did not account for the better levels of cognitive functioning in women than men.
CONCLUSIONS


In a large cohort of older overweight or obese adults with type 2 diabetes mellitus, differences in brain volumes and white matter disease were apparent between women and men, but these did not account for a lower prevalence of cognitive impairment in women compared with men in this cohort.
TRIAL REGISTRATION


NCT00017953.",2020,"Their magnitude did not vary significantly with respect to age, body mass index, intervention assignment, or APOE-ε4 genotype.","['participants had completed an average of 10 years of random assignment to either multidomain intervention targeting weight loss or a control condition of diabetes support and education', 'older overweight and obese women and men with type 2 diabetes mellitus', 'women than men', '224 women and 95 men (mean age 69 years) with histories of type 2 diabetes mellitus and overweight or obesity', 'Overweight and Obese Adults With Type 2 Diabetes', 'older overweight or obese adults with type 2 diabetes mellitus']",[],"['Brain Volumes and Cerebral Blood Flow', 'cognitive functioning', 'brain volumes and white matter disease', 'Total (summed gray and white) matter volumes, white matter hyperintensity volumes, and cerebral blood flow across five brain regions of interest']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C1272247', 'cui_str': 'Target weight'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0270612', 'cui_str': 'White Matter Diseases'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1269776', 'cui_str': 'Gray'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0682708'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}]",224.0,0.0891676,"Their magnitude did not vary significantly with respect to age, body mass index, intervention assignment, or APOE-ε4 genotype.","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Winston-Salem, NC.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Hayden', 'Affiliation': 'Department of Social Sciences and Health Policy, Winston-Salem, NC.'}, {'ForeName': 'Samuel N', 'Initials': 'SN', 'LastName': 'Lockhart', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Hussein N', 'Initials': 'HN', 'LastName': 'Yassine', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California. Los Angeles, CA.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Hoscheidt', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Yasar', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Luchsinger', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Biostatistics and Data Science, Winston-Salem, NC.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Diaz Brinton', 'Affiliation': 'University of Arizona Center for Innovation in Brain Science, The University of Arizona Health Sciences, Tucson, AZ.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Carmichael', 'Affiliation': 'Biomedical Imaging Center, Pennington Biomedical Research Center, Baton Rouge, LA.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz090']
420,32316129,Acute Effects of the Consumption of  Passiflora setacea  Juice on Metabolic Risk Factors and Gene Expression Profile in Humans.,"BACKGROUND


Passiflora setacea  (PS) is a passionfruit variety of the Brazilian savannah and is a rich source of plant food bioactives with potential anti-inflammatory activity. This study aimed to investigate the effect of an acute intake of PS juice upon inflammation, metabolic parameters, and gene expression on circulating immune cells in humans.
METHODS


Overweight male volunteers ( n  = 12) were enrolled in two double-blind placebo-controlled studies. Blood samples were collected from fasting volunteers 3 h after the consumption of 250 mL of PS juice or placebo (PB). Metabolic parameters (insulin, glucose, total cholesterol, high-density lipoprotein (LDL), high-density lipoprotein (HDL), and total triglycerides) and circulating cytokines were evaluated (study 1). Peripheral blood mononuclear cell (PBMC) from the same subjects were isolated and RNA was extracted for transcriptomic analyses using microarrays (study 2).
RESULTS


Insulin and homeostatic model assessment for insulin resistance (HOMA-IR) levels decreased statistically after the PS juice intake, whereas HDL level increased significantly. Interleukin (IL)-17A level increased after placebo consumption, whereas its level remained unchanged after PS juice consumption. Nutrigenomic analyses revealed 1327 differentially expressed genes after PS consumption, with modulated genes involved in processes such as inflammation, cell adhesion, or cytokine-cytokine receptor.
CONCLUSION


Taken together, these clinical results support the hypothesis that PS consumption may help the prevention of cardiometabolic diseases.",2020,"Nutrigenomic analyses revealed 1327 differentially expressed genes after PS consumption, with modulated genes involved in processes such as inflammation, cell adhesion, or cytokine-cytokine receptor.
","['Overweight male volunteers ( n  = 12', 'humans', 'Humans']","['PS juice or placebo (PB', 'placebo', 'Interleukin']","['HDL level', 'IL)-17A level', 'Metabolic parameters (insulin, glucose, total cholesterol, high-density lipoprotein (LDL), high-density lipoprotein (HDL), and total triglycerides) and circulating cytokines', 'Blood samples', 'Insulin and homeostatic model assessment for insulin resistance (HOMA-IR) levels', 'inflammation, cell adhesion, or cytokine-cytokine receptor', 'Peripheral blood mononuclear cell (PBMC', 'Metabolic Risk Factors and Gene Expression Profile']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0007577', 'cui_str': 'Cell Adhesion'}, {'cui': 'C0206552', 'cui_str': 'Cytokine Receptor'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1449575', 'cui_str': 'Microarray Analysis'}]",12.0,0.189443,"Nutrigenomic analyses revealed 1327 differentially expressed genes after PS consumption, with modulated genes involved in processes such as inflammation, cell adhesion, or cytokine-cytokine receptor.
","[{'ForeName': 'Isabella de Araújo Esteves', 'Initials': 'IAE', 'LastName': 'Duarte', 'Affiliation': 'Postgraduate Program in Human Nutrition, College of Health Sciences, Campus Universitário Darcy Ribeiro, Universidade de Brasília, Brasília DF 70.910-900, Brazil.'}, {'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Milenkovic', 'Affiliation': 'Unité de Nutrition Humaine, Université Clermont Auvergne, INRAE, UNH, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Tatiana Karla Dos Santos', 'Initials': 'TKDS', 'LastName': 'Borges', 'Affiliation': 'Laboratory of Cellular Immunology, Faculty of Medicine, University of Brasilia, Brasilia DF 70.910-900, Brazil.'}, {'ForeName': 'Artur Jordão de Magalhães', 'Initials': 'AJM', 'LastName': 'Rosa', 'Affiliation': 'Laboratory of Food Science, Embrapa Cerrados, Planaltina DF 73.310-970, Brazil.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Morand', 'Affiliation': 'Unité de Nutrition Humaine, Université Clermont Auvergne, INRAE, UNH, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Livia de Lacerda de', 'Initials': 'LL', 'LastName': 'Oliveira', 'Affiliation': 'Postgraduate Program in Human Nutrition, College of Health Sciences, Campus Universitário Darcy Ribeiro, Universidade de Brasília, Brasília DF 70.910-900, Brazil.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Costa', 'Affiliation': 'Laboratory of Food Science, Embrapa Cerrados, Planaltina DF 73.310-970, Brazil.'}]",Nutrients,['10.3390/nu12041104']
421,32316158,Effects of a Workplace-Based Virtual-Run Intervention Among University Employees.,"Virtual runs (real running or walking activities using online recording platforms) have been popular in the digital age and could have the potential to promote physical activity (PA) in workplaces. We investigated the effects of a virtual-run intervention (VRI) on PA and body compositions among university employees. A three-phase intervention was conducted over 6 months: 0 (pre-intervention), 1 (during intervention), and 2 (post-intervention). Exercise stages of change were assessed in phases 0 and 2. Body compositions (body weight, body mass index, fat mass, percentage of fat mass, fat-free mass, and percentage of fat-free mass) were assessed in phases 0, 1, and 2. Running and walking times were recorded through a mobile application. Forty-seven participants completed the VRI. The number of participants at the maintenance stage increased from 34.04% in phase 0 ( n  = 16) to 63.83% in phase 2 ( n  = 30). None of the changes in body compositions were significant ( p  > 0.05). The median running and walking time among participants at the maintenance stage was 151.85 (interquartile range, 109.15) min/week. Future research should focus on approaches to improve the efficacy of VRIs and their effects on health outcomes.",2020,None of the changes in body compositions were significant ( p  > 0.05).,"['university employees', 'University Employees']","['Workplace-Based Virtual-Run Intervention', 'virtual-run intervention (VRI', 'Virtual runs (real running or walking activities using online recording platforms']","['Body compositions (body weight, body mass index, fat mass, percentage of fat mass, fat-free mass, and percentage of fat-free mass', 'median running and walking time', 'body compositions']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",47.0,0.0386114,None of the changes in body compositions were significant ( p  > 0.05).,"[{'ForeName': 'Apichai', 'Initials': 'A', 'LastName': 'Wattanapisit', 'Affiliation': 'School of Medicine, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Waluka', 'Initials': 'W', 'LastName': 'Amaek', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Watcharawat', 'Initials': 'W', 'LastName': 'Promma', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Phatcharawadee', 'Initials': 'P', 'LastName': 'Srirug', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Uchane', 'Initials': 'U', 'LastName': 'Cheangsan', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Satit', 'Initials': 'S', 'LastName': 'Khwanchum', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Wattana', 'Initials': 'W', 'LastName': 'Chadakorn', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Kanittha', 'Initials': 'K', 'LastName': 'Eardmak', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}, {'ForeName': 'Narumon', 'Initials': 'N', 'LastName': 'Chadakorn', 'Affiliation': 'Walailak University Running for Health Club, Thasala, Nakhon Si Thammarat 80161, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17082745']
422,32316168,Effect of an Eleven-Day Altitude Training Program on Aerobic and Anaerobic Performance in Adolescent Runners.,"Background and Objectives:  We evaluated the effect of an eleven-day altitude training camp on aerobic and anaerobic fitness in trained adolescent runners.  Materials and Methods:  Twenty adolescent (14-18 yrs) middle- and long-distance runners (11 males and 9 females; 16.7 ± 0.8 yrs), with at least two years of self-reported consistent run training, participated in this study. Eight of the subjects (4 females/4 males) constituted the control group, whereas twelve subjects (5 females/7 males) took part in a structured eleven-day altitude training camp, and training load was matched between groups. Primary variables of interest included changes in aerobic (VO 2 max) and anaerobic (30 s Wingate test) power. We also explored the relationships between running velocity and blood lactate levels before and after the altitude training camp.  Results:  Following 11 days of altitude training, desirable changes ( p  < 0.01) in VO 2 max (+13.6%), peak relative work rate (+9.6%), and running velocity at various blood lactate concentrations (+5.9%-9.6%) were observed. Meanwhile, changes in Wingate anaerobic power (+5.1%) were statistically insignificant ( p  > 0.05).  Conclusions:  Short duration altitude appears to yield meaningful improvements in aerobic but not anaerobic power in trained adolescent endurance runners.",2020,"Following 11 days of altitude training, desirable changes ( p  < 0.01) in VO 2 max (+13.6%), peak relative work rate (+9.6%), and running velocity at various blood lactate concentrations (+5.9%-9.6%) were observed.","['Twenty adolescent (14-18 yrs) middle- and long-distance runners (11 males and 9 females; 16.7 ± 0.8 yrs), with at least two years of self-reported consistent run training, participated in this study', 'Eight of the subjects (4 females/4 males) constituted the control group, whereas twelve subjects (5 females/7 males) took part in a structured eleven-day altitude training camp, and training load was matched between groups', 'trained adolescent endurance runners', 'trained adolescent runners', 'Adolescent Runners']","['eleven-day altitude training camp', 'Eleven-Day Altitude Training Program']","['changes in aerobic (VO 2 max) and anaerobic (30 s Wingate test) power', 'running velocity at various blood lactate concentrations', 'aerobic and anaerobic fitness', 'Aerobic and Anaerobic Performance', 'Wingate anaerobic power', 'running velocity and blood lactate levels', 'peak relative work rate']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",,0.0147409,"Following 11 days of altitude training, desirable changes ( p  < 0.01) in VO 2 max (+13.6%), peak relative work rate (+9.6%), and running velocity at various blood lactate concentrations (+5.9%-9.6%) were observed.","[{'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Bahenský', 'Affiliation': 'Department of Sports Studies, Faculty of Education, University of South Bohemia, 371 15 České Budějovice, Czech Republic.'}, {'ForeName': 'Václav', 'Initials': 'V', 'LastName': 'Bunc', 'Affiliation': 'Physical Training and Education, Sports Motor Skills Laboratory, Faculty of Sports, Charles University, 165 52 Prague, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Tlustý', 'Affiliation': 'Department of Mathematics, Faculty of Education, University of South Bohemia, 371 15 České Budějovice, Czech Republic.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Grosicki', 'Affiliation': 'Biodynamics and Human Performance Center, Georgia Southern University, Savannah, GA 31419, USA.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56040184']
423,32316197,Effectiveness of Motivational Interviewing in Regard to Activities of Daily Living and Motivation for Rehabilitation among Stroke Patients.,"BACKGROUND


Stroke patients urgently need rehabilitation to enhance activities of daily living. This study aims to determine whether motivational interviewing (MI) improves the performance of activities of daily living and enhances motivation for rehabilitation among first-stroke patients.
METHODS


A quasi-experimental design was used in this study. The study recruited 65 patients between March and October 2016. Before the intervention, all patients received routine care. The experimental group (n = 33) received weekly sessions of MI for 6 weeks, whereas the control group (n = 32) received individual attention from a research nurse weekly for 6 weeks. Structured questionnaires were used to collect data, including demographic data, activities of daily living data (Barthel index {BI} and instrumental activities of daily living {IADLs} scale), and rehabilitation motivation data.
RESULTS


The BI and IADLs scores significantly improved with time in both the experimental and control groups. The generalized estimating equation approach showed that at 6 weeks and 3 months after the intervention, the rehabilitation motivation scores in the experimental group were respectively 3.10 and 2.54 points higher than those in the control group, with significant differences.
CONCLUSIONS


MI could effectively enhance motivation for rehabilitation among stroke patients.",2020,The BI and IADLs scores significantly improved with time in both the experimental and control groups.,"['Stroke Patients', 'first-stroke patients', '65 patients between March and October 2016', 'stroke patients']","['Motivational Interviewing', 'individual attention from a research nurse weekly for 6 weeks', 'routine care', 'motivational interviewing (MI']","['demographic data, activities of daily living data (Barthel index {BI} and instrumental activities of daily living {IADLs} scale), and rehabilitation motivation data', 'BI and IADLs scores', 'rehabilitation motivation scores']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0687693', 'cui_str': 'Research nurse'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",65.0,0.0288482,The BI and IADLs scores significantly improved with time in both the experimental and control groups.,"[{'ForeName': 'Hsiao-Mei', 'Initials': 'HM', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Chung Shan Medical University, Taichung 40201, Taiwan.'}, {'ForeName': 'Hsiao-Lu', 'Initials': 'HL', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Yuhing Junior College of Health Care & Management, Kaohsiung 80776, Taiwan.'}, {'ForeName': 'Fu-Chi', 'Initials': 'FC', 'LastName': 'Yang', 'Affiliation': 'College of General Education, National Chin-Yi University of Technology, Taichung 40201, Taiwan.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Chiu', 'Affiliation': 'Department of Nursing, Chung Shan Medical University, Taichung 40201, Taiwan.'}, {'ForeName': 'Shu-Yuan', 'Initials': 'SY', 'LastName': 'Chao', 'Affiliation': 'Department of Nursing, Hungkuang University, Taichung 43302, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17082755']
424,31933461,Barriers and Enablers to Intervention Uptake and Health Reporting in a Water Intervention Trial in Rural India: A Qualitative Explanatory Study.,"Consumption of unsafe drinking water contributes to the global disease burden, necessitating identification and implementation of effective, acceptable, and sustainable water interventions in resource-limited settings. In a quantitative stepped-wedge cluster randomized trial of a community-based water intervention in rural India, we identified low rates of intervention uptake and reported diarrhea. To better understand and explain these findings, we performed a qualitative study examining barriers and enablers to intervention uptake and health reporting using the COM-B model, where capabilities, opportunities, and motivators interact to generate behavior. We conducted 20 focus groups and one semi-structured interview with participants and four focus groups with data collectors. Multifactorial barriers to intervention uptake included distorted perceptions of water-related health effects, implementation issues that reduced treated water availability; convenience of, and preference for, alternative drinking water sources; delivery of water to plastic storage tanks (perceived as affecting water quality and taste); and resistance to change. Enablers included knowledge of water-related health risks, proximity to tanks, and social opportunity. Barriers to health reporting included variability in interpretation of illness, suspicion regarding the consequences of reporting disease, weariness with repeated questions, and perceived inaction on health data already provided; low survey implementation fidelity was also important. Enablers included surveyor initiatives to encourage reporting and a sense of social responsibility. This qualitative explanatory study allowed better understanding of our quantitative results. It also identified obstacles and facilitators to implementing and evaluating community water interventions, providing insight on how to achieve better intervention uptake and health reporting in future studies.",2020,"Multifactorial barriers to intervention uptake included distorted perceptions of water-related health effects, implementation issues that reduced treated water availability; convenience of, and preference for, alternative drinking water sources; delivery of water to plastic storage tanks (perceived as affecting water quality and taste); and resistance to change.",['Rural India'],['community-based water intervention'],"['knowledge of water-related health risks, proximity to tanks, and social opportunity']","[{'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0336821', 'cui_str': 'Tank - military vehicle (physical object)'}]",,0.0316373,"Multifactorial barriers to intervention uptake included distorted perceptions of water-related health effects, implementation issues that reduced treated water availability; convenience of, and preference for, alternative drinking water sources; delivery of water to plastic storage tanks (perceived as affecting water quality and taste); and resistance to change.","[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'McGuinness', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': ""O'Toole"", 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Darshini', 'Initials': 'D', 'LastName': 'Ayton', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Giriyan', 'Affiliation': 'The Energy and Resources Institute (TERI), Panaji, India.'}, {'ForeName': 'Chetan A', 'Initials': 'CA', 'LastName': 'Gaonkar', 'Affiliation': 'The Energy and Resources Institute (TERI), Panaji, India.'}, {'ForeName': 'Ramkrishna', 'Initials': 'R', 'LastName': 'Vhaval', 'Affiliation': 'The Energy and Resources Institute (TERI), Panaji, India.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Leder', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0486']
425,31680625,Examining key sociodemographic characteristics of adolescents and young adults with cancer: A post hoc analysis of the Promoting Resilience in Stress Management randomized clinical trial.,"BACKGROUND


The ""Promoting Resilience in Stress Management"" intervention is a skills-based, early palliative care intervention with demonstrated efficacy in adolescents and young adults with cancer.
AIM


Utilizing data from a randomized clinical trial of Promoting Resilience in Stress Management versus Usual Care, we examined whether response to Promoting Resilience in Stress Management differed across key sociodemographic characteristics.
DESIGN


Adolescents and young adults with cancer completed patient-reported outcome measures of resilience, hope, benefit-finding, quality of life, and distress at enrollment and 6 months. Participants were stratified by sex, age, race, and neighborhood socioeconomic disadvantage based on home address (Area Deprivation Index scores with 8-10 = most disadvantaged). Differences in the magnitude of effect sizes between stratification subgroups were noted using a conservative cutoff of  d  > 0.5.
SETTING/PARTICIPANTS


Participants were 12 to 25 years old, English-speaking, and receiving cancer care at Seattle Children's Hospital.
RESULTS


In total, 92 adolescents and young adults (48 Promoting Resilience in Stress Management, 44 Usual Care) completed baseline measures. They were 43% female, 73% 12 to 17 years old, 64% White, and 24% most disadvantaged. Effect sizes stratified by sex, age, and race were in an expected positive direction and of similar magnitude for the majority of outcomes with some exceptions in magnitude of treatment effect. Those who lived in less disadvantaged neighborhoods benefited more from Promoting Resilience in Stress Management, and those living in most disadvantaged neighborhoods benefited less.
CONCLUSION


The ""Promoting Resilience in Stress Management"" intervention demonstrated a positive effect for the majority of outcomes regardless of sex, age, and race. It may not be as helpful for adolescents and young adults living in disadvantaged neighborhoods. Future studies must confirm its generalizability and integrate opportunities for improvement by targeting individual needs.",2020,"The ""Promoting Resilience in Stress Management"" intervention demonstrated a positive effect for the majority of outcomes regardless of sex, age, and race.","['They were 43% female, 73% 12 to 17\u2009years old, 64% White, and 24% most disadvantaged', 'Participants were stratified by sex, age, race, and neighborhood socioeconomic disadvantage based on home address (Area Deprivation Index scores with 8-10\u2009=\u2009most disadvantaged', '92 adolescents and young adults (48 Promoting Resilience in Stress Management, 44 Usual Care) completed baseline measures', ""Participants were 12 to 25\u2009years old, English-speaking, and receiving cancer care at Seattle Children's Hospital"", 'adolescents and young adults with cancer', 'Adolescents and young adults with cancer completed patient', 'adolescents and young adults living in disadvantaged neighborhoods']",[],"['resilience, hope, benefit-finding, quality of life, and distress']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205393', 'cui_str': 'Most (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0034380'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",92.0,0.144515,"The ""Promoting Resilience in Stress Management"" intervention demonstrated a positive effect for the majority of outcomes regardless of sex, age, and race.","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lau', 'Affiliation': ""Center for Clinical and Translational Research, Palliative Care and Resilience Research Center, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Bradford', 'Affiliation': ""Center for Clinical and Translational Research, Palliative Care and Resilience Research Center, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Steineck', 'Affiliation': ""Center for Clinical and Translational Research, Palliative Care and Resilience Research Center, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': ""Center for Clinical and Translational Research, Palliative Care and Resilience Research Center, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Bona', 'Affiliation': 'Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Joyce P', 'Initials': 'JP', 'LastName': 'Yi-Frazier', 'Affiliation': ""Center for Clinical and Translational Research, Palliative Care and Resilience Research Center, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McCauley', 'Affiliation': 'Division of Child Psychiatry, Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Rosenberg', 'Affiliation': ""Center for Clinical and Translational Research, Palliative Care and Resilience Research Center, Seattle Children's Research Institute, Seattle, WA, USA.""}]",Palliative medicine,['10.1177/0269216319886215']
426,32145827,"Treatment of advanced AIDS-associated Kaposi sarcoma in resource-limited settings: a three-arm, open-label, randomised, non-inferiority trial.","BACKGROUND


Optimal treatment regimens for AIDS-associated Kaposi sarcoma, a frequent contributor to morbidity and mortality among people with HIV, have not been systematically evaluated in low-income and middle-income countries, where the disease is most common. In this study, we aimed to investigate optimal treatment strategies for advanced stage disease in areas of high prevalence and limited resources.
METHODS


In this open-label, non-inferiority trial, we enrolled people with HIV and advanced stage AIDS-associated Kaposi sarcoma attending 11 AIDS Clinical Trials Group sites in Brazil, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. Eligible participants were randomly assigned (1:1:1) with a centralised computer system to receive either intravenous bleomycin and vincristine or oral etoposide (the investigational arms), or intravenous paclitaxel (the control arm), together with antiretroviral therapy (ART; combined efavirenz, tenofovir disoproxil fumarate, and emtricitabine). The primary outcome was progression-free survival (PFS) at week 48, using a 15% non-inferiority margin to compare the investigational groups against the active control group. Safety was assessed in all eligible treated study participants. The study was registered with ClinicalTrials.gov, NCT01435018.
FINDINGS


334 participants were enrolled between Oct 1, 2013, and March 8, 2018, when the study was closed early due to inferiority of the bleomycin and vincristine plus ART arm, as per the recommendations of the Data and Safety Monitoring Board (DSMB). The etoposide plus ART arm also closed due to inferiority in March, 2016, following a DSMB recommendation. Week-48 PFS rates were higher in the paclitaxel plus ART arm than in both investigational arms. The absolute differences in PFS were -30% (95% CI -52 to -8) for the comparison of paclitaxel plus ART (week 48 PFS 50%, 32 to 67; n=59) and etoposide plus ART (20%, 6 to 33; n=59), and -20% (-33% to -7%) for the comparison of paclitaxel plus ART (64%, 55 to 73; n=138) and bleomycin and vincristine plus ART (44%, 35 to 53; n=132). Both CIs overlapped the non-inferiority margin. The most common adverse events, in 329 eligible participants who began treatment, were neutropenia (48 [15%]), low serum albumin (33 [10%]), weight loss (29 [9%]), and anaemia (28 [9%]), occurring at similar frequency across treatment arms.
INTERPRETATION


Non-inferiority of either investigational intervention was not shown, with paclitaxel plus ART showing superiority to both oral etoposide plus ART and bleomycin and vincristine plus ART, supporting its use in treating advanced AIDS-associated Kaposi sarcoma in resource-limited settings.
FUNDING


US National Institute of Allergy and Infectious Diseases and National Cancer Institute, National Institutes of Health.",2020,"The primary outcome was progression-free survival (PFS) at week 48, using a 15% non-inferiority margin to compare the investigational groups against the active control group.","['334 participants were enrolled between Oct 1, 2013, and March 8, 2018, when the study was closed early due to inferiority of the', 'people with HIV', 'enrolled people with HIV and advanced stage AIDS-associated Kaposi sarcoma attending 11 AIDS Clinical Trials Group sites in Brazil, Kenya, Malawi, South Africa, Uganda, and Zimbabwe', 'advanced stage disease in areas of high prevalence and limited resources', 'Eligible participants']","['antiretroviral therapy (ART; combined efavirenz, tenofovir disoproxil fumarate, and emtricitabine', 'paclitaxel plus ART', 'etoposide plus ART', 'intravenous bleomycin and vincristine or oral etoposide (the investigational arms), or intravenous paclitaxel', 'bleomycin and vincristine plus ART']","['progression-free survival (PFS', 'low serum albumin', 'weight loss', 'neutropenia', 'PFS', 'Safety', 'Week-48 PFS rates']","[{'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0036220', 'cui_str': 'Kaposi Sarcoma'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1320290', 'cui_str': 'Clinical trial group'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",329.0,0.329646,"The primary outcome was progression-free survival (PFS) at week 48, using a 15% non-inferiority margin to compare the investigational groups against the active control group.","[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Krown', 'Affiliation': 'AIDS Malignancy Consortium, New York, NY, USA. Electronic address: krowns@mskcc.org.'}, {'ForeName': 'Carlee B', 'Initials': 'CB', 'LastName': 'Moser', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'MacPhail', 'Affiliation': 'Clinical HIV Research Unit, Department of Internal Medicine, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Matining', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Godfrey', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Stephanie R', 'Initials': 'SR', 'LastName': 'Caruso', 'Affiliation': 'Frontier Science Foundation, Amherst, NY, USA.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'UNC Project-Malawi, Lilongwe, Malawi; Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Division of Infectious Diseases, Chapel Hill, NC, USA.'}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': 'Parirenyatwa Clinical Research Site, Harare, Zimbabwe.'}, {'ForeName': 'Mulinda', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Johns Hopkins Research Project, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Naftali W', 'Initials': 'NW', 'LastName': 'Busakhala', 'Affiliation': 'Moi University School of Medicine, Eldoret, Kenya.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Okuku', 'Affiliation': 'Uganda Cancer Institute, Kampala, Uganda.'}, {'ForeName': 'Josphat', 'Initials': 'J', 'LastName': 'Kosgei', 'Affiliation': 'Kenya Medical Research Institute, USA Medical Directorate for Africa/Kenya, Kericho, Kenya.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Hoagland', 'Affiliation': 'Oswaldo Cruz Foundation, Evandro Chagas National Institute of Infectious Diseases, Rio de Janeiro, Brazil.'}, {'ForeName': 'Noluthando', 'Initials': 'N', 'LastName': 'Mwelase', 'Affiliation': 'Clinical HIV Research Unit, Department of Internal Medicine, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Vincent O', 'Initials': 'VO', 'LastName': 'Oliver', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Centers for Disease Control and Prevention, Kisumu CRS, HIV-Research Branch, Kisumu, Kenya.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Burger', 'Affiliation': 'Family Clinical Research Unit CRS, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa; Division of Radiation Oncology, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Mngqibisa', 'Affiliation': 'Durban International Clinical Research Site, Enhancing Care Foundation, Durban, South Africa.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Nokta', 'Affiliation': 'Office of HIV and AIDS Malignancy, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Margaret Z', 'Initials': 'MZ', 'LastName': 'Borok', 'Affiliation': 'Department of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)33222-2']
427,32315969,"Comic book-based educational program on epilepsy for high-school students: Results from a pilot study in the Gran Chaco region, Bolivia.","INTRODUCTION


In low- and middle-income countries (LMIC), epilepsy still represents a significant health challenge. In the Bolivian Chaco, we have previously found high levels of stigma towards people with epilepsy (PWE) especially expressed by high school students. In order to increase the knowledge about epilepsy, we have tested a comic book-based intervention on a sample of high school students.
METHODS


The study has been conducted in the Bolivian Chaco region where two urban and two rural classrooms have been randomly selected. Students have been administered a knowledge, attitudes, and practices (KAP) questionnaire, and then they underwent a comic book-based educational program where they were randomly assigned either to an autonomous reading or a character interpretation methodology. The same KAP questionnaire has been administered after the teaching session and at a three months follow-up. Mean KAP scores at the baseline were compared with the after teaching and the three-month assessment.
RESULTS


Eighty-three students with a mean age of 15.5 ± 0.9 years, of whom 38 (45.8%) males, were recruited. After the comic book session, students improved in the global score (p < 0.001) and in the knowledge (p < 0.001), attitudes (p = 0.004), and practices (p < 0.001) subscores. Both the autonomous reading and the character interpretation groups significantly improved in the global score, but only the latter improved in all the subscores. At the three months follow-up, there were no differences in the global, knowledge, and attitudes subscores, compared with scores immediately after the intervention.
CONCLUSION


Using a comic book to teach about epilepsy led to a significant improvement in the knowledge, attitudes, and practices about the disease in high school students of LMIC. This teaching strategy can be easily implemented in LMIC.",2020,"At the three months follow-up, there were no differences in the global, knowledge, and attitudes subscores, compared with scores immediately after the intervention.
","['high-school students', 'Eighty-three students with a mean age of 15.5\u202f±\u202f0.9\u202fyears, of whom 38 (45.8%) males, were recruited', 'Bolivian Chaco region where two urban and two rural classrooms']","['Comic book-based educational program', 'comic book-based educational program']","['global score', 'global, knowledge, and attitudes subscores', 'Mean KAP scores']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}]","[{'cui': 'C0681446', 'cui_str': 'Comic Books'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",83.0,0.032308,"At the three months follow-up, there were no differences in the global, knowledge, and attitudes subscores, compared with scores immediately after the intervention.
","[{'ForeName': 'Calogero Edoardo', 'Initials': 'CE', 'LastName': 'Cicero', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Giuliano', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Todaro', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Colli', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Padilla', 'Affiliation': 'Center of Anthropological Researches of the Teko Guaraní, Gutierrez, Bolivia.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Vilte', 'Affiliation': 'Center of Anthropological Researches of the Teko Guaraní, Gutierrez, Bolivia.'}, {'ForeName': 'Elizabeth Blanca', 'Initials': 'EB', 'LastName': 'Crespo Gómez', 'Affiliation': 'Hospital Universitario Hernández Vera, Santa Cruz, Bolivia.'}, {'ForeName': 'Walter Mario', 'Initials': 'WM', 'LastName': 'Camargo Villarreal', 'Affiliation': 'Bolivian League Against Epilepsy, Santa Cruz, Bolivia.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Bartoloni', 'Affiliation': 'Department of Experimental and Clinical Medicine, Infectious and Tropical Diseases Unit, University of Florence, Florence, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zappia', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Nicoletti', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy. Electronic address: anicolet@unict.it.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107076']
428,32234534,"Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial.","BACKGROUND


Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications.
METHODS


In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02439749.
FINDINGS


From June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0·999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was -3·9 mm Hg (Bayesian 95% credible interval -6·2 to -1·6) and for office systolic blood pressure the difference was -6·5 mm Hg (-9·6 to -3·5). No major device-related or procedural-related safety events occurred up to 3 months.
INTERPRETATION


SPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications.
FUNDING


Medtronic.",2020,"No major device-related or procedural-related safety events occurred up to 3 months.
","['44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm', 'From June 25, 2015, to Oct 15, 2019, 331 patients']","['catheter-based renal denervation', 'renal denervation', 'renal denervation or sham procedure']","['No major device-related or procedural-related safety events', 'baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure', 'blood pressure', '24-h systolic blood pressure', 'office systolic blood pressure']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",331.0,0.54398,"No major device-related or procedural-related safety events occurred up to 3 months.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg (Saar), Germany. Electronic address: michael.boehm@uks.eu.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, GA, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': 'Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg (Saar), Germany; Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Weber', 'Affiliation': 'SUNY Downstate College of Medicine, Brooklyn, NY, USA.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Schmieder', 'Affiliation': 'Universitätsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tsioufis', 'Affiliation': 'National and Kapodistrian University of Athens, Hippocratio Hospital, Athens, Greece.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Konstantinidis', 'Affiliation': 'National and Kapodistrian University of Athens, Hippocratio Hospital, Athens, Greece.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Baylor Scott and White Heart and Vascular Hospital, Dallas, TX, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'East', 'Affiliation': 'Baylor Scott and White Heart and Vascular Hospital, Dallas, TX, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Lee', 'Affiliation': 'Stanford Hospital and Clinics, Stanford, CA, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Ma', 'Affiliation': 'Stanford Hospital and Clinics, Stanford, CA, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Ewen', 'Affiliation': 'Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg (Saar), Germany.'}, {'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Cohen', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wilensky', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Chandan M', 'Initials': 'CM', 'LastName': 'Devireddy', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Lea', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Schmid', 'Affiliation': 'Universitätsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Weil', 'Affiliation': 'Sana Cardiomed Heart Center, LÜbeck, Germany.'}, {'ForeName': 'Tolga', 'Initials': 'T', 'LastName': 'Agdirlioglu', 'Affiliation': 'Sana Cardiomed Heart Center, LÜbeck, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Reedus', 'Affiliation': 'Piedmont Heart Institute, Atlanta, GA, USA.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Jefferson', 'Affiliation': 'TriStar Centennial Medical Center, Nashville, TN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reyes', 'Affiliation': 'TriStar Centennial Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': ""D'Souza"", 'Affiliation': 'The Royal Devon and Exeter Hospital, Exeter, UK.'}, {'ForeName': 'Andrew S P', 'Initials': 'ASP', 'LastName': 'Sharp', 'Affiliation': 'University Hospital of Wales, Cardiff, UK; University of Exeter, Exeter, UK.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Sharif', 'Affiliation': 'Galway University Hospitals and National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fahy', 'Affiliation': 'Medtronic, Santa Rosa, CA, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'DeBruin', 'Affiliation': 'Medtronic, Santa Rosa, CA, USA.'}, {'ForeName': 'Sidney A', 'Initials': 'SA', 'LastName': 'Cohen', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Medtronic, Santa Rosa, CA, USA.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Brar', 'Affiliation': 'Medtronic, Santa Rosa, CA, USA.'}, {'ForeName': 'Raymond R', 'Initials': 'RR', 'LastName': 'Townsend', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30554-7']
429,30768418,A Randomized Controlled Trial: Attachment-Based Family and Nondirective Supportive Treatments for Youth Who Are Suicidal.,"OBJECTIVE


To evaluate the efficacy of attachment-based family therapy (ABFT) compared with a family-enhanced nondirective supportive therapy (FE-NST) for decreasing adolescents' suicide ideation and depressive symptoms.
METHOD


A randomized controlled trial of 129 adolescents who are suicidal ages 12- to 18-years-old (49% were African American) were randomized to ABFT (n = 66) or FE-NST (n = 63) for 16 weeks of treatment. Assessments occurred at baseline and 4, 8, 12, and 16 weeks. Trajectory of change and clinical recovery were calculated for suicidal ideation and depressive symptoms.
RESULTS


There was no significant between-group difference in the rate of change in self-reported ideation (Suicidal Ideation Questionnaire-Jr; F 1,127  = 181, p = .18). Similar results were found for depressive symptoms. However, adolescents receiving ABFT showed a significant decrease in suicide ideation (t 127  = 12.61, p < .0001; effect size, d = 2.24). Adolescents receiving FE-NST showed a similar significant decrease (t 127  = 10.88, p < .0001; effect size, d = 1.93). Response rates (ie, ≥50% decrease in suicide ideation symptoms from baseline) at post-treatment were 69.1% for ABFT versus 62.3% for FE-NST.
CONCLUSION


Contrary to expectations, ABFT did not perform better than FE-NST. The 2 treatments produced substantial decreases in suicidal ideation and depressive symptoms that were comparable to or better than those reported in other more intensive, multicomponent treatments. The equivalent outcomes could be attributed to common treatment elements, different active mechanisms, or regression to the mean. Future studies will explore long-term follow up, secondary outcomes, and potential moderators and mediators.
CLINICAL TRIAL REGISTRATION INFORMATION


Attachment-Based Family Therapy for Suicidal Adolescents; http://clinicaltrials.gov; NCT01537419.",2019,"Adolescents receiving FE-NST showed a similar significant decrease (t 127  = 10.88, p < .0001; effect size, d = 1.93).","['129 adolescents who are suicidal ages', ""adolescents' suicide ideation and depressive symptoms"", 'Youth', '12- to 18-years-old (49% were African American']","['family-enhanced nondirective supportive therapy (FE-NST', 'FE-NST', 'ABFT', 'attachment-based family therapy (ABFT']","['Response rates', 'suicidal ideation and depressive symptoms', 'depressive symptoms', 'suicide ideation symptoms', 'suicide ideation', 'rate of change in self-reported ideation (Suicidal Ideation Questionnaire']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015618', 'cui_str': 'Family Therapy'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",129.0,0.263649,"Adolescents receiving FE-NST showed a similar significant decrease (t 127  = 10.88, p < .0001; effect size, d = 1.93).","[{'ForeName': 'Guy S', 'Initials': 'GS', 'LastName': 'Diamond', 'Affiliation': 'Center for Family Intervention Science, Drexel University, Philadelphia, PA. Electronic address: guy.diamond@drexel.edu.'}, {'ForeName': 'R Roger', 'Initials': 'RR', 'LastName': 'Kobak', 'Affiliation': 'University of Delaware, Newark.'}, {'ForeName': 'E Stephanie', 'Initials': 'ES', 'LastName': 'Krauthamer Ewing', 'Affiliation': 'Center for Family Intervention Science, Drexel University, Philadelphia, PA.'}, {'ForeName': 'Suzanne A', 'Initials': 'SA', 'LastName': 'Levy', 'Affiliation': 'Center for Family Intervention Science, Drexel University, Philadelphia, PA.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Herres', 'Affiliation': 'The College of New Jersey, Ewing Township.'}, {'ForeName': 'Jody M', 'Initials': 'JM', 'LastName': 'Russon', 'Affiliation': 'Virginia Tech, Blacksburg.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gallop', 'Affiliation': 'Applied Statistics Program, West Chester University, PA.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.10.006']
430,32320566,Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease.,"BACKGROUND


Acute graft-versus-host disease (GVHD) remains a major limitation of allogeneic stem-cell transplantation; not all patients have a response to standard glucocorticoid treatment. In a phase 2 trial, ruxolitinib, a selective Janus kinase (JAK1 and JAK2) inhibitor, showed potential efficacy in patients with glucocorticoid-refractory acute GVHD.
METHODS


We conducted a multicenter, randomized, open-label, phase 3 trial comparing the efficacy and safety of oral ruxolitinib (10 mg twice daily) with the investigator's choice of therapy from a list of nine commonly used options (control) in patients 12 years of age or older who had glucocorticoid-refractory acute GVHD after allogeneic stem-cell transplantation. The primary end point was overall response (complete response or partial response) at day 28. The key secondary end point was durable overall response at day 56.
RESULTS


A total of 309 patients underwent randomization; 154 patients were assigned to the ruxolitinib group and 155 to the control group. Overall response at day 28 was higher in the ruxolitinib group than in the control group (62% [96 patients] vs. 39% [61]; odds ratio, 2.64; 95% confidence interval [CI], 1.65 to 4.22; P<0.001). Durable overall response at day 56 was higher in the ruxolitinib group than in the control group (40% [61 patients] vs. 22% [34]; odds ratio, 2.38; 95% CI, 1.43 to 3.94; P<0.001). The estimated cumulative incidence of loss of response at 6 months was 10% in the ruxolitinib group and 39% in the control group. The median failure-free survival was considerably longer with ruxolitinib than with control (5.0 months vs. 1.0 month; hazard ratio for relapse or progression of hematologic disease, non-relapse-related death, or addition of new systemic therapy for acute GVHD, 0.46; 95% CI, 0.35 to 0.60). The median overall survival was 11.1 months in the ruxolitinib group and 6.5 months in the control group (hazard ratio for death, 0.83; 95% CI, 0.60 to 1.15). The most common adverse events up to day 28 were thrombocytopenia (in 50 of 152 patients [33%] in the ruxolitinib group and 27 of 150 [18%] in the control group), anemia (in 46 [30%] and 42 [28%], respectively), and cytomegalovirus infection (in 39 [26%] and 31 [21%]).
CONCLUSIONS


Ruxolitinib therapy led to significant improvements in efficacy outcomes, with a higher incidence of thrombocytopenia, the most frequent toxic effect, than that observed with control therapy. (Funded by Novartis; REACH2 ClinicalTrials.gov number, NCT02913261.).",2020,"The median failure-free survival was considerably longer with ruxolitinib than with control (5.0 months vs. 1.0 month; hazard ratio for relapse or progression of hematologic disease, non-relapse-related death, or addition of new systemic therapy for acute GVHD, 0.46; 95% CI, 0.35 to 0.60).","['patients 12 years of age or older who had glucocorticoid-refractory acute GVHD after allogeneic stem-cell transplantation', '309 patients underwent randomization; 154 patients were assigned to the ruxolitinib group and 155 to the control group', 'patients with glucocorticoid-refractory acute GVHD']",['oral ruxolitinib'],"['efficacy outcomes', 'efficacy and safety', 'hazard ratio for relapse or progression of hematologic disease, non-relapse-related death', 'thrombocytopenia', 'Overall response', 'Durable overall response', 'anemia', 'cumulative incidence of loss of response', 'median failure-free survival', 'durable overall response', 'median overall survival', 'overall response (complete response or partial response', 'cytomegalovirus infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2931926', 'cui_str': 'ruxolitinib'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}]",309.0,0.161116,"The median failure-free survival was considerably longer with ruxolitinib than with control (5.0 months vs. 1.0 month; hazard ratio for relapse or progression of hematologic disease, non-relapse-related death, or addition of new systemic therapy for acute GVHD, 0.46; 95% CI, 0.35 to 0.60).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zeiser', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'von Bubnoff', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Mohty', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Dietger', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Reuven', 'Initials': 'R', 'LastName': 'Or', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Szer', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Wagner', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Tsila', 'Initials': 'T', 'LastName': 'Zuckerman', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Bruyère', 'Initials': 'B', 'LastName': 'Mahuzier', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Wilke', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Kunal K', 'Initials': 'KK', 'LastName': 'Gandhi', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Socié', 'Affiliation': ""From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) - all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women's Hospital, Brisbane, QLD (J.B.), and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC (J.S.) - all in Australia; Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Sorbonne and INSERM Unité Mixte de Recherche (UMR) 938 (M.M.), and AP-HP, Hématologie-Transplantation, Hôpital St. Louis, Université de Paris and INSERM UMR 976 (G.S.), Paris, and Novartis Pharma, Rueil-Malmaison (B.M.) - all in France; the Cancer Immunotherapy and Immunobiology Research Center, Hadassah University Hospital, Jerusalem (R.O.), and the Hematology Institute and Bone Marrow Transplantation, Clinical Research Institute at Rambam, Rambam Health Care Campus, Haifa (T.Z.) - both in Israel; Novartis Pharmaceuticals, East Hanover, NJ (J.X., K.K.G.); and Novartis Pharma, Basel, Switzerland (C.W.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1917635']
431,32286882,HDL-apoA-I kinetics in response to 16 wk of exercise training in men with nonalcoholic fatty liver disease.,"Nonalcoholic fatty liver disease (NAFLD) is characterized by low-circulating concentration of high-density lipoprotein cholesterol (HDL-C) and raised triacylglycerol (TAG). Exercise reduces hepatic fat content, improves insulin resistance and increases clearance of very-low-density lipoprotein-1 (VLDL 1 ). However, the effect of exercise on TAG and HDL-C metabolism is unknown. We randomized male participants to 16 wk of supervised, moderate-intensity aerobic exercise ( n  = 15), or conventional lifestyle advice ( n  = 12). Apolipoprotein A-I (apoA-I) and VLDL-TAG and apolipoprotein B (apoB) kinetics were investigated using stable isotopes (1-[ 13 C]-leucine and 1,1,2,3,3- 2 H 5  glycerol) pre- and postintervention. Participants underwent MRI/spectroscopy to assess changes in visceral fat. Results are means ± SD. At baseline, there were no differences between exercise and control groups for age (52.4 ± 7.5 vs. 52.8 ± 10.3 yr), body mass index (BMI: 31.6 ± 3.2 vs. 31.7 ± 3.6 kg/m 2 ), and waist circumference (109.3 ± 7.5 vs. 110.0 ± 13.6 cm). Percentage of liver fat was 23.8 (interquartile range 9.8-32.5%). Exercise reduced body weight (101.3 ± 10.2 to 97.9 ± 12.2 kg;  P  < 0.001) and hepatic fat content [from 19.6%, interquartile range (IQR) 14.6-36.1% to 8.9% (4.4-17.8%);  P  = 0.001] and increased the fraction HDL-C concentration (measured following ultracentrifugation) and apoA-I pool size with no change in the control group. However, plasma and VLDL 1 -TAG concentrations and HDL-apoA-I fractional catabolic rate (FCR) and production rate (PR) did not change significantly with exercise. Both at baseline (all participants) and after exercise there was an inverse correlation between apoA-I pool size and VLDL-TAG and -apoB pool size. The modest effect of exercise on HDL metabolism may be explained by the lack of effect on plasma and VLDL 1 -TAG.",2020,"Exercise reduced body weight (101.3±10.2 to 97.9±12.2 kg; P<0.001) and hepatic fat content (from 19.6%, IQR 14.6-36.1% to 8.9% (4.4-17.8%); P=0.001) and increased the fraction HDL-C concentration (measured following ultracentrifugation) and apoA-I pool size with no change in the control group.","['male participants to 16 weeks of', 'men with non-alcoholic fatty liver disease (NAFLD']","['MRI/spectroscopy', 'exercise training', 'supervised, moderate-intensity aerobic exercise (n=15) or conventional lifestyle advice']","['Exercise reduced body weight', 'visceral fat', 'hepatic fat content', 'BMI', 'Percentage liver fat', 'waist circumference', 'hepatic fat content, improves insulin resistance and increases clearance of very-low density lipoprotein-1 (VLDL1', 'Apolipoprotein A-I (apoA-I) and VLDL-TAG and apolipoprotein B (apoB) kinetics', 'fraction HDL-C concentration', 'plasma and VLDL1 TAG concentrations and HDL-apoA-I fractional catabolic rate (FCR) and production rate (PR']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0078207', 'cui_str': 'Very low density lipoprotein triglyceride'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",,0.147255,"Exercise reduced body weight (101.3±10.2 to 97.9±12.2 kg; P<0.001) and hepatic fat content (from 19.6%, IQR 14.6-36.1% to 8.9% (4.4-17.8%); P=0.001) and increased the fraction HDL-C concentration (measured following ultracentrifugation) and apoA-I pool size with no change in the control group.","[{'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Whyte', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Shojaee-Moradie', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Sharaf E', 'Initials': 'SE', 'LastName': 'Sharaf', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Cuthbertson', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Graham J', 'Initials': 'GJ', 'LastName': 'Kemp', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Barrett', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Jackson', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Roselle A', 'Initials': 'RA', 'LastName': 'Herring', 'Affiliation': 'Centre for Diabetes, Endocrinology, and Research, Royal Surrey County Hospital, Guildford, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Centre for Diabetes, Endocrinology, and Research, Royal Surrey County Hospital, Guildford, United Kingdom.'}, {'ForeName': 'E Louise', 'Initials': 'EL', 'LastName': 'Thomas', 'Affiliation': 'Research Centre for Optimal Health, School of Life Sciences, University of Westminster, London, United Kingdom.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': 'Research Centre for Optimal Health, School of Life Sciences, University of Westminster, London, United Kingdom.'}, {'ForeName': 'A Margot', 'Initials': 'AM', 'LastName': 'Umpleby', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, United Kingdom.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00019.2020']
432,31823141,Effect of short-term methotrexate discontinuation on rheumatoid arthritis disease activity: post-hoc analysis of two randomized trials.,"To investigate the effects of short-term discontinuation of methotrexate (MTX) on disease activity in patients with rheumatoid arthritis (RA) taking a stable dose of MTX. A post-hoc analysis of two randomized controlled trials was used to investigate the effects of temporary MTX discontinuation (for 2 weeks or 4 weeks) on responses to seasonal influenza vaccination. The impact of MTX discontinuation on the RA disease activity score (DAS28) and RA flare rate during discontinuation and after reintroduction was examined. The DAS28 increased during the 4-week MTX discontinuation period, before returning to baseline after reintroduction. The overall flare-free survival period did not differ between the groups (log rank p = 0.142). However, during the 4-week MTX discontinuation period, more patients in the MTX-hold group than in the MTX-continue group experienced a flare (20.5% vs. 7.4%, respectively; p = 0.058). After resumption of MTX, the flare rate did not differ between groups. The flare rates in the MTX-continue group and the 2-week and 4-week MTX-hold groups were 5.8%, 10.8% and 20.5%, respectively (p < 0.01). The change in the DAS28 from baseline did not differ significantly between the MTX-continue and the 2-week MTX-discontinue groups. However, there was a significant difference between the 4-week MTX-hold group and the MTX-continue group (p = 0.005). Short-term discontinuation of MTX for up to 2 weeks is safe, whereas discontinuation for 4 weeks is associated with a transient increase in disease flares and activity in RA patients taking a stable MTX dose.Key Points• Methotrexate discontinuation for 2 weeks is safe.• Methotrexate discontinuation for 4 weeks transiently increases flare risk and disease activity.• Disease flare risk and disease activity return to baseline after restarting methotrexate treatment.",2020,The overall flare-free survival period did not differ between the groups (log rank p = 0.142).,"['rheumatoid arthritis disease activity', 'patients with rheumatoid arthritis (RA']","['methotrexate (MTX', 'MTX', 'short-term methotrexate discontinuation', 'temporary MTX discontinuation']","['DAS28', 'disease activity', 'RA disease activity score (DAS28) and RA flare rate', 'flare rates', 'disease flares and activity', 'flare risk and disease activity.•', 'Disease flare risk and disease activity return', 'overall flare-free survival period', 'flare rate']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0245859,The overall flare-free survival period did not differ between the groups (log rank p = 0.142).,"[{'ForeName': 'Jin Kyun', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Min Jung', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Yunhee', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Division of Medical Statistics, Medical Research Collaborating Center, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Winthrop', 'Affiliation': 'Division of Infectious Diseases, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Yeong Wook', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Eun Bong', 'Initials': 'EB', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea. leb7616@snu.ac.kr.'}]",Clinical rheumatology,['10.1007/s10067-019-04857-y']
433,31367979,Twelve-month efficacy and safety of glaucoma filtration device for surgery in patients with normal-tension glaucoma.,"PURPOSE


To assess the efficacy and safety of filtration surgery using the EX-PRESS glaucoma filtration device in patients with normal-tension glaucoma (NTG).
STUDY DESIGN


Prospective, single-arm, multicenter interventional case series.
METHODS


Eyes with NTG underwent EX-PRESS implantation with or without cataract surgery. The efficacy and safety were assessed at 1 day; 1 and 2 weeks; and 1, 3, 6, and 12 months after surgery. The main outcome measure was reduction in intraocular pressure (IOP) from baseline at 3, 6, and 12 months after surgery. Safety assessments included adverse event incidence, postoperative inflammation, and corneal endothelial cell density.
RESULTS


Thirty-two Japanese patients (37 eyes) with NTG were enrolled. The mean IOP decreased from 14.8 ± 2.3 mmHg at baseline to 10.0 ± 3.1 mmHg at 12 months after surgery (mean reduction 4.9 ± 4.2 mmHg [31.1%]; P < .0001). IOP-lowering medication use decreased from a mean of 3.3 medications per eye before surgery to 0.1 medications per eye at 12 months after surgery. IOP reductions > 20% were achieved by 61.5% of the eyes at 12 months. Adverse events were typical for filtration procedures, and none was deemed device-related. Postoperative inflammation was mild and self-limiting. The mean corneal endothelial cell density had decreased by 3.3% at 12 months after surgery.
CONCLUSION


The EX-PRESS glaucoma filtration device is safe and effective for filtration surgery in patients with NTG, providing mean IOP reduction consistent with recommendations based on the Collaborative NTG Study.",2019,"The EX-PRESS glaucoma filtration device is safe and effective for filtration surgery in patients with NTG, providing mean IOP reduction consistent with recommendations based on the Collaborative NTG Study.","['patients with normal-tension glaucoma (NTG', 'Eyes with', 'patients with normal-tension glaucoma', 'Thirty-two Japanese patients (37 eyes) with NTG were enrolled', 'patients with NTG']","['glaucoma filtration device', 'filtration surgery using the EX-PRESS glaucoma filtration device', 'NTG underwent EX-PRESS implantation with or without cataract surgery']","['intraocular pressure (IOP', 'Adverse events', 'IOP reductions', 'mean IOP', 'adverse event incidence, postoperative inflammation, and corneal endothelial cell density', 'efficacy and safety', 'mean corneal endothelial cell density', 'Postoperative inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152136', 'cui_str': 'Normal Tension Glaucoma'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0242673', 'cui_str': 'Surgery, Filtration'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",32.0,0.112248,"The EX-PRESS glaucoma filtration device is safe and effective for filtration surgery in patients with NTG, providing mean IOP reduction consistent with recommendations based on the Collaborative NTG Study.","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Aihara', 'Affiliation': 'Department of Ophthalmology, University of Tokyo School of Medicine, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. aihara-tky@umin.net.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Kuwayama', 'Affiliation': 'Fukushima Eye Clinic, Fukushima, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Miyata', 'Affiliation': 'Miyata Ophthalmic Hospital, Miyazaki, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ohtani', 'Affiliation': 'Kagoshima Miyata Eye Clinic, Kagoshima, Japan.'}, {'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Ideta', 'Affiliation': 'Ideta Eye Hospital, Kumamoto, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Shinseikai Toyama Hospital, Toyama, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Sasaki', 'Affiliation': 'Alcon Japan, Tokyo, Japan.'}, {'ForeName': 'Shiroaki', 'Initials': 'S', 'LastName': 'Shirato', 'Affiliation': 'Yotsuya-Shirato Eye Clinic, Tokyo, Japan.'}]",Japanese journal of ophthalmology,['10.1007/s10384-019-00682-7']
434,32320533,First-Year Economic and Quality of Life Effects of the RAINBOW Intervention to Treat Comorbid Obesity and Depression.,"OBJECTIVE


Obesity and depression are prevalent and often co-occurring conditions in the United States. The Research Aimed at Improving Both Mood and Weight (RAINBOW) randomized trial demonstrated the effectiveness of an integrated intervention for adults with both conditions. Characterizing the intervention's economic effects is important for broader dissemination and implementation.
METHODS


This study evaluated the cost (2018 US dollars) and health-related quality of life (HRQoL) impacts during RAINBOW's first year, comparing intervention (n = 204) and usual-care groups (n = 205). Outcomes included intervention delivery costs, differential changes in antidepressant medication spending compared with the pretrial year, differential changes in medical services spending compared with the pretrial year, and HRQoL changes from baseline using Euroqol-5D US utility weights.
RESULTS


RAINBOW's 1-year delivery cost per person was $2,251. Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027). Annual antidepressant medication spending had a larger, nonsignificant increase ($89 [95% CI: -$20 to $197]; P = 0.109). Annual spending on medical care services had a smaller, nonsignificant decrease (-$54 [95% CI: -$832 to $941]; P = 0.905). HRQoL had a nonsignificant increase (0.011 [95% CI: -0.025 to 0.047]; P = 0.546).
CONCLUSIONS


The RAINBOW intervention's economic value will depend on how its 1-year improvements in obesity and depression translate into long-term reduced morbidity, delayed mortality, or averted costs.",2020,"Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027).",['adults with both conditions'],['integrated intervention'],"['Annual spending on medical care services', 'intervention delivery costs, differential changes in antidepressant medication spending compared with the pretrial year, differential changes in medical services spending compared with the pretrial year, and HRQoL changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0723905,"Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027).","[{'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Goldhaber-Fiebert', 'Affiliation': 'Stanford Health Policy Group, Centers for Health Policy and Primary Care and Outcomes Research, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Prince', 'Affiliation': 'Stanford Health Policy Group, Centers for Health Policy and Primary Care and Outcomes Research, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Epidemiology and Population Health, School of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, School of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'Center for Communications Science, RTI International, Seattle, Washington, USA.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Division of Academic Internal Medicine and Geriatrics, Department of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22805']
435,32318813,Acute physiological responses to combined blood flow restriction and low-level laser.,"PURPOSE


Blood flow restriction (BFR) is an innovation in fitness to train muscles with low loads at low oxygen levels. Low-level laser therapy (LLLT) is a bio-energetic approach to alleviate muscle fatigue during resistance training. This study investigated the immediate effect of LLLT pre-conditioning on BFR that accelerates muscle fatigue due to ischemia.
METHODS


Fifteen young adults participated in this study of a crossover randomized design. They completed a low-load contraction with various pre-conditioning (blood flow restriction with low-level laser therapy (LLLT + BFR), blood flow restriction with sham low-level laser therapy (BFR), and control). Force fluctuation dynamics, muscle oxygen saturation of hemoglobin and myoglobin (SmO 2 ), and discharge patterns of motor units (MU) were compared.
RESULTS


Normalized SmO 2  during low-load contractions significantly varied with the pre-contraction protocols (Control (83.6 ± 3.0%) > LLLT + BFR (70.3 ± 2.8%) > BFR (55.4 ± 2.4%). Also, force fluctuations and MU discharge varied with the pre-contraction protocols. Multi-scale entropy and mean frequency of force fluctuations were greater in the LLLT + BFR condition (31.95 ± 0.67) than in the BFR condition (29.47 ± 0.73). The mean inter-spike interval of MUs was greater in the LLLT + BFR condition (53.32 ± 2.70 ms) than in the BFR condition (45.04 ± 1.08 ms). In particular, MUs with higher recruitment thresholds exhibited greater LLLT-related discharge complexity (LLLT + BFR (0.201 ± 0.012) > BFR (0.154 ± 0.006)).
CONCLUSIONS


LLLT pre-conditioning can minimize the BFR-related decline in muscle oxygen saturation, leading to force gradation and MU discharge in a cost-effective and complex manner.",2020,"This study investigated the immediate effect of LLLT pre-conditioning on BFR that accelerates muscle fatigue due to ischemia.
",['Fifteen young adults'],"['LLLT pre-conditioning on BFR', 'various pre-conditioning (blood flow restriction with low-level laser therapy (LLLT\u2009+\u2009BFR), blood flow restriction with sham low-level laser therapy (BFR), and control', 'combined blood flow restriction and low-level laser', 'Low-level laser therapy (LLLT', 'Blood flow restriction (BFR']","['force fluctuations and MU discharge', 'mean inter-spike interval of MUs', 'Force fluctuation dynamics, muscle oxygen saturation of hemoglobin and myoglobin (SmO 2 ), and discharge patterns of motor units (MU', 'Multi-scale entropy and mean frequency of force fluctuations']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0024944', 'cui_str': 'Mauritius'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0574401', 'cui_str': 'Samoan language'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",15.0,0.0350489,"This study investigated the immediate effect of LLLT pre-conditioning on BFR that accelerates muscle fatigue due to ischemia.
","[{'ForeName': 'Yi-Ching', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Therapy, College of Medical Science and Technology, Chung Shan Medical University, Taichung City, 40201, Taiwan.'}, {'ForeName': 'Yu-Han', 'Initials': 'YH', 'LastName': 'Su', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan City, 70101, Taiwan.'}, {'ForeName': 'Yen-Ting', 'Initials': 'YT', 'LastName': 'Lin', 'Affiliation': 'Physical Education Office, Asian University, Taichung City, 41354, Taiwan.'}, {'ForeName': 'Chien-Chun', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Medical Device Innovation Center, National Cheng Kung University, Tainan City, Taiwan.'}, {'ForeName': 'Ing-Shiou', 'Initials': 'IS', 'LastName': 'Hwang', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan City, 70101, Taiwan. ishwang@mail.ncku.edu.tw.'}]",European journal of applied physiology,['10.1007/s00421-020-04378-6']
436,32095393,Clinical Evaluation of an Off-the-Shelf Allogeneic Adipose Matrix for Soft Tissue Reconstruction.,"Biomaterials derived from human adipose extracellular matrix have shown promise in vitro and in animal studies as an off-the-shelf adipogenic matrix for sustained volume replacement. Herein, we report the results of a randomized prospective study conducted with allograft adipose matrix (AAM) grafted into the pannus of presurgical abdominoplasty patients 3 or 6 months before scheduled surgery. This is the first report of a longitudinal histologic analysis of AAM in clinical use.
Methods


Ten healthy patients undergoing elective abdominoplasty were recruited to receive AAM before surgery. Enrolled subjects were randomized into either a 3-month follow-up cohort or a 6-month follow-up cohort. Subjects were monitored for adverse events associated with AAM grafting in addition to undergoing serial biopsy. Following surgical excision of the pannus, representative samples from the AAM surgical sites were stained and evaluated with hematoxylin and eosin for tissue morphology, Masson's trichrome for collagen, and perilipin for adipocytes.
Results


All subjects tolerated AAM with no severe adverse events reported. At 3 months following implantation, AAM remained visible within the confines of the subjects' native surrounding adipose tissue with sparse adipocytes apparent within the matrix. By 6 months, AAM had remodeled and was primarily composed of perilipin-positive adipocytes. Histologic analysis confirmed tissue remodeling (hematoxylin and eosin), adipogenesis (perilipin), and angiogenesis (Masson's trichrome) occurred with the presence of AAM.
Conclusions


AAM is a safe, allogeneic, off-the-shelf regenerative matrix that is adipogenic and noninflammatory and promotes angiogenesis.",2020,All subjects tolerated AAM with no severe adverse events reported.,"['Ten healthy patients undergoing elective abdominoplasty were recruited to receive AAM before surgery', 'presurgical abdominoplasty patients 3 or 6 months before scheduled surgery']",['allograft adipose matrix (AAM'],"[""tissue remodeling (hematoxylin and eosin), adipogenesis (perilipin), and angiogenesis (Masson's trichrome""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0018964', 'cui_str': 'Hydroxybrasilin'}, {'cui': 'C0014448', 'cui_str': 'eosin'}, {'cui': 'C0596843', 'cui_str': 'Adipogenesis'}, {'cui': 'C0443326', 'cui_str': 'Trichrome (qualifier value)'}]",10.0,0.0256852,All subjects tolerated AAM with no severe adverse events reported.,"[{'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kokai', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Wesley N', 'Initials': 'WN', 'LastName': 'Sivak', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Schilling', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Arivarasan', 'Initials': 'A', 'LastName': 'Karunamurthy', 'Affiliation': 'Division of Molecular & Genomic Pathology, Pittsburgh, Pa.'}, {'ForeName': 'Francesco M', 'Initials': 'FM', 'LastName': 'Egro', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'M Asher', 'Initials': 'MA', 'LastName': 'Schusterman', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Minteer', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Patsy', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': ""D'Amico"", 'Affiliation': 'Department of Plastic Surgery, Mount Sinai School of Medicine, New York, N.Y.'}, {'ForeName': 'J Peter', 'Initials': 'JP', 'LastName': 'Rubin', 'Affiliation': 'Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pa.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000002574']
437,32320131,International Consultation on Incontinence Questionnaire-Satisfaction: psychometric testing of a new patient-reported outcome measure for the evaluation of satisfaction after urological surgery.,"OBJECTIVES


To evaluate the psychometric properties of a new patient-reported outcome measure (PROM), the International Consultation on Incontinence Questionnaire-Satisfaction (ICIQ-S), to assess satisfaction after urological surgery.
SUBJECTS/PATIENTS AND METHODS


Following item development, the developmental ICIQ-S (dICIQ-S) was used within in a randomised control trial comparing two types of surgery for male prostatic obstruction at 1.5, 3, and 12 months after surgery. Reliability was assessed by Cronbach's α and construct validity by the correlation of scores with concurrently administered PROMs of known validity: ICIQ-Male Lower Urinary Tract Symptoms (LUTS), International Prostate Symptom Score, and the ICIQ-LUTS Quality of Life.
RESULTS


A total of 410 men were included in the trial. Missing data was generally low for the dICIQ-S [mean (range) 1.6 (<1-3.1)%] except for the items 'complications' 6.8% and 'satisfaction with sex-life' 9.2%. High ceiling effects were found in all items. Factor analysis identified six items related to surgical outcomes (Cronbach's α 0.89), which have formed the scored part of the ICIQ-S, together with a standalone overall satisfaction item, scored 0-10. Seven additional unscored items, related to satisfaction with experiences and expectations, were also retained. As hypothesised, post-surgery dICIQ-S scores were correlated with reduced symptoms and improved quality of life as measured by the concurrent PROMs.
CONCLUSION


The results support the validity and reliability of a scored six-item domain for evaluating satisfaction with surgical outcomes, together with a standalone scored overall satisfaction item. The further unscored seven standalone items are anticipated to be used as the basis for adaptation and further validation of the ICIQ-S in different patient populations.",2020,"As hypothesised, post-surgery dICIQ-S scores were correlated with reduced symptoms and improved quality of life as measured by the concurrent PROMs.
","['new patient', 'A total of 410 men were included in the trial']",[],['quality of life'],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",410.0,0.0449834,"As hypothesised, post-surgery dICIQ-S scores were correlated with reduced symptoms and improved quality of life as measured by the concurrent PROMs.
","[{'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Uren', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Cotterill', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Hashim', 'Initials': 'H', 'LastName': 'Hashim', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dharmesh', 'Initials': 'D', 'LastName': 'Kapoor', 'Affiliation': 'Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, Bristol, UK.'}]",BJU international,['10.1111/bju.15091']
438,32315696,Testing the effects of transcranial direct current stimulation (tDCS) on the face inversion effect and the N170 event-related potentials (ERPs) component.,"The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces). We combined tDCS and EEG simultaneously to examine the effects of tDCS on the face inversion effect behaviourally and on the N170 ERPs component. The results from two experiments (overall N = 112) show that anodal tDCS delivered at Fp3 site for 10 min at 1.5 mA (double-blind and between-subjects) can reduce behaviourally the face inversion effect compared to sham (control) stimulation. The ERP results provide some evidence for tDCS being able to influence the face inversion effect on the N170. Specifically, we find a dissociation of the tDCS-induced effects where for the N170 latencies the tDCS reduces the usual face inversion effect (delayed N170 in response to inverted vs. upright faces) compared to sham. Contrarily, the same tDCS procedure on the same participants increased the inversion effect seen in the N170 amplitudes by making the negative deflection for the inverted faces that much greater than that for upright faces. We interpret our results in the context of the literature on the face inversion effect and the N170 peak component. In doing so, we extend our results to previous studies investigating the effects of tDCS on perceptual learning and face recognition.",2020,The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces).,[],"['tDCS', 'transcranial direct current stimulation (tDCS', 'anodal tDCS']",['perceptual learning and face recognition'],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",,0.0243991,The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces).,"[{'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Civile', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK. Electronic address: c.civile@exeter.ac.uk.'}, {'ForeName': 'Emika', 'Initials': 'E', 'LastName': 'Waguri', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Quaglia', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Wooster', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Curtis', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Rossy', 'Initials': 'R', 'LastName': 'McLaren', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Aureliu', 'Initials': 'A', 'LastName': 'Lavric', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'I P L', 'Initials': 'IPL', 'LastName': 'McLaren', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK. Electronic address: i.p.l.mclaren@exeter.ac.uk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107470']
439,32316288,Relative Validity of an Online Herb and Spice Consumption Questionnaire.,"Culinary herbs and spices contribute bioactives to the diet, which act to reduce systemic inflammation and associated disease. Investigating the health effects of herb/spice consumption is hampered, however, by a scarcity of dietary assessment tools designed to collect herb/spice data. The objective of this study was to determine the relative validity of an online 28-item herb/spices intake questionnaire (HSQ). In randomized order, 62 volunteers residing in Idaho, USA, completed the online Diet History Questionnaire III + the HSQ followed one week later by one of two comparative methods: 7-day food records or three telephone-administered 24-h dietary recalls. Relative validity of the HSQ was tested two ways: (1) by comparing herb/spice intakes between the HSQ and comparator, and (2) by determining the correlation between herb/spice data and Healthy Eating Index 2015 score. The HSQ and both comparators identified black pepper, cinnamon and garlic powder as the three most commonly used herbs/spices. The HSQ captured significantly higher measures of the number and amount of herbs/spices consumed than the comparators. The number of herbs/spices consumed was significantly directly correlated with diet quality for the HSQ. These results support the ability of the HSQ to record general herb/spice use, yet suggest that further validation testing is needed.",2020,The HSQ captured significantly higher measures of the number and amount of herbs/spices consumed than the comparators.,"['62 volunteers residing in Idaho, USA, completed the']","['online 28-item herb/spices intake questionnaire (HSQ', 'Online Herb and Spice Consumption Questionnaire', 'online Diet History Questionnaire III + the HSQ followed one week later by one of two comparative methods: 7-day food records or three telephone-administered 24-h dietary recalls']",[],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0020787', 'cui_str': 'Idaho'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0037910', 'cui_str': 'Spice'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453242', 'cui_str': 'Herbs and spices'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",[],62.0,0.0272359,The HSQ captured significantly higher measures of the number and amount of herbs/spices consumed than the comparators.,"[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Blanton', 'Affiliation': 'Department of Nutrition and Dietetics, Idaho State University, Pocatello, ID 83201-8117, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17082757']
440,32316310,"Tissue Expansion Improves the Outcome and Predictability for Alveolar Bone Augmentation: Prospective, Multicenter, Randomized Controlled Trial.","OBJECTIVES


The purpose of this study was to evaluate the effectiveness of the intraoral use of subperiosteally placed self-inflating tissue expanders for subsequent bone augmentation and implant integrity.
MATERIAL AND METHODS


A prospective, multicenter, randomized controlled trial was performed on patients requiring alveolar bone graft for dental implant insertion. Patients were assigned to three groups: tissue expansion and tunneling graft (TET group), tissue expansion and conventional bone graft (TEG), and control group without tissue expansion. Dimensional changes of soft tissue and radiographic vertical bone gain, retention, and peri-implant marginal bone changes were evaluated and secondary outcomes; clinical complications and thickness changes of expanded overlying tissue were assessed.
RESULTS


Among 75 patients screened, a total of 57 patients were included in the final analysis. Most patients showed uneventful soft tissue expansion without any inflammatory sign or symptoms. Ultrasonographic measurements of overlying gingiva revealed no thinning after tissue expansion ( p  > 0.05). Mean soft vertical and horizontal tissue measurements at the end of its expansion were 5.62 and 6.03 mm, respectively. Significantly higher vertical bone gain was shown in the TEG (5.71 ± 1.99 mm) compared with that in the control patients (4.32 ± 0.97 mm;  p  < 0.05). Hard tissue retention- measured by bone resorption after 6 months-showed that control group showed higher amount of vertical (2.06 ± 1.00 mm) and horizontal bone resorption (1.69 ± 0.81 mm) compared to that of the TEG group ( p  < 0.05).
CONCLUSION


The self-inflating tissue expander effectively augmented soft tissue volume and both conventional bone graft and tunneling techniques confirmed their effectiveness in bone augmentation. With greater amount of bone gain and better 6 month hard tissue integrity, the TEG group compared to the control group-without tissue expansion-showed that the combined modality of tissue expander use and guided bone regeneration (GBR) technique may improve the outcome and predictability of hard tissue augmentation.",2020,Significantly higher vertical bone gain was shown in the TEG (5.71 ± 1.99 mm) compared with that in the control patients (4.32 ± 0.97 mm;  p  < 0.05).,"['patients requiring alveolar bone graft for dental implant insertion', '75 patients screened, a total of 57 patients were included in the final analysis']","['TEG', 'guided bone regeneration (GBR) technique', 'subperiosteally placed self-inflating tissue expanders', 'Tissue Expansion', 'tissue expansion and tunneling graft (TET group), tissue expansion and conventional bone graft (TEG), and control group without tissue expansion']","['Mean soft vertical and horizontal tissue measurements', 'uneventful soft tissue expansion', 'Ultrasonographic measurements of overlying gingiva revealed no thinning after tissue expansion', 'Hard tissue retention- measured by bone resorption', 'bone gain', 'horizontal bone resorption', 'vertical bone gain', 'Dimensional changes of soft tissue and radiographic vertical bone gain, retention, and peri-implant marginal bone changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0407708', 'cui_str': 'Alveolar bone graft'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0040290', 'cui_str': 'Tissue Expansion'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0040289', 'cui_str': 'Tissue expander'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C2959953', 'cui_str': 'Tetum language'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0040290', 'cui_str': 'Tissue Expansion'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}]",57.0,0.0461616,Significantly higher vertical bone gain was shown in the TEG (5.71 ± 1.99 mm) compared with that in the control patients (4.32 ± 0.97 mm;  p  < 0.05).,"[{'ForeName': 'Soo-Hwan', 'Initials': 'SH', 'LastName': 'Byun', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sacred Heart Hospital, Hallym University Medical Center, Kyonggi-do 14068, Korea.'}, {'ForeName': 'Sun-Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, College of Medicine, Ewha Womans University, Seoul 07985, Korea.'}, {'ForeName': 'Sura', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, College of Medicine, Ewha Womans University, Seoul 07985, Korea.'}, {'ForeName': 'Ho', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Research Society of Gangnam Oral and Maxillofacial Surgeons, Seoul 07985, Korea.'}, {'ForeName': 'Ho-Kyung', 'Initials': 'HK', 'LastName': 'Lim', 'Affiliation': 'Research Society of Gangnam Oral and Maxillofacial Surgeons, Seoul 07985, Korea.'}, {'ForeName': 'Ju-Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sacred Heart Hospital, Hallym University Medical Center, Kyonggi-do 14068, Korea.'}, {'ForeName': 'Ui-Lyong', 'Initials': 'UL', 'LastName': 'Lee', 'Affiliation': 'Research Society of Gangnam Oral and Maxillofacial Surgeons, Seoul 07985, Korea.'}, {'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Sun-Jong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, College of Medicine, Ewha Womans University, Seoul 07985, Korea.'}, {'ForeName': 'Min-Kyoung', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Bio R&D Center, Osstem implant Co., Ltd. Busan 07789, Korea.'}, {'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Research Society of Gangnam Oral and Maxillofacial Surgeons, Seoul 07985, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9041143']
441,32316331,Wireless Motion Sensors-Useful in Assessing the Effectiveness of Physiotherapeutic Methods Used in Patients with Knee Osteoarthritis-Preliminary Report.,"Osteoarthritis of the knee (OAK) is characterized by pain, limitation of joint mobility, and significant deterioration of proprioception resulting in functional decline. This study assessed proprioception in OAK patients following two ten-day rehabilitation programs using the Orthyo ®  system. Fifty-four study participants with clinical symptoms and radiological signs of OAK were randomly divided into an exercise group ( n  = 27) or a manual therapy group ( n  = 27). The control group consisted of 27 volunteers with radiological signs of OAK, but with no clinical symptoms or prior history of rehabilitation. The following parameters were assessed: knee proprioception using inertial sensors and a mobile application, patients' function using Western Ontario and McMaster Universities osteoarthritis index (WOMAC), and pain intensity using the visual analog scale (VAS). Following rehabilitation, knee proprioception tests did not improve in either study group. Both study groups showed significant improvement of the WOMAC-assessed function (exercise group:  p  < 0.01, manual therapy group:  p  = 0.01) and a significant decrease ( p  < 0.01) of VAS-assessed pain following rehabilitation, but the post-therapy results did not differ significantly between the aforementioned groups. The Orthyo ®  system provided a quick and accurate assessment of the knee joint position sense. There was no direct relationship between functionality, pain, and proprioception threshold in the knee joint.",2020,"Both study groups showed significant improvement of the WOMAC-assessed function (exercise group:  p  < 0.01, manual therapy group:  p  = 0.01) and a significant decrease ( p  < 0.01) of VAS-assessed pain following rehabilitation, but the post-therapy results did not differ significantly between the aforementioned groups.","['Fifty-four study participants with clinical symptoms and radiological signs of OAK', 'OAK patients following two ten-day rehabilitation programs using the Orthyo ®  system', '27 volunteers with radiological signs of OAK, but with no clinical symptoms or prior history of rehabilitation', 'Patients with Knee Osteoarthritis-Preliminary Report']","['manual therapy', 'exercise group']","['functionality, pain, and proprioception threshold', ""knee proprioception using inertial sensors and a mobile application, patients' function using Western Ontario and McMaster Universities osteoarthritis index (WOMAC), and pain intensity using the visual analog scale (VAS"", 'VAS-assessed pain following rehabilitation', 'WOMAC-assessed function']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0330302', 'cui_str': 'Genus Quercus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]",54.0,0.0147846,"Both study groups showed significant improvement of the WOMAC-assessed function (exercise group:  p  < 0.01, manual therapy group:  p  = 0.01) and a significant decrease ( p  < 0.01) of VAS-assessed pain following rehabilitation, but the post-therapy results did not differ significantly between the aforementioned groups.","[{'ForeName': 'Jagoda', 'Initials': 'J', 'LastName': 'Goślińska', 'Affiliation': 'Department of Rehabilitation and Physiotherapy, University of Medical Sciences, 28 Czerwca 1956 Str., No 135/147, 60-545 Poznań, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Wareńczak', 'Affiliation': 'Department of Rehabilitation and Physiotherapy, University of Medical Sciences, 28 Czerwca 1956 Str., No 135/147, 60-545 Poznań, Poland.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Miedzyblocki', 'Affiliation': 'Department of Rehabilitation and Physiotherapy, University of Medical Sciences, 28 Czerwca 1956 Str., No 135/147, 60-545 Poznań, Poland.'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Hejdysz', 'Affiliation': 'Department of Rehabilitation and Physiotherapy, University of Medical Sciences, 28 Czerwca 1956 Str., No 135/147, 60-545 Poznań, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Adamczyk', 'Affiliation': 'Department of Rehabilitation and Physiotherapy, University of Medical Sciences, 28 Czerwca 1956 Str., No 135/147, 60-545 Poznań, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Sip', 'Affiliation': 'Department of Rehabilitation and Physiotherapy, University of Medical Sciences, 28 Czerwca 1956 Str., No 135/147, 60-545 Poznań, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Chlebuś', 'Affiliation': 'Department of Rehabilitation and Physiotherapy, University of Medical Sciences, 28 Czerwca 1956 Str., No 135/147, 60-545 Poznań, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Gośliński', 'Affiliation': 'Aisens Sp. z o. o., Lubeckiego 23A, 60-348 Poznań, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Owczarek', 'Affiliation': 'Aisens Sp. z o. o., Lubeckiego 23A, 60-348 Poznań, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Woźniak', 'Affiliation': 'Aisens Sp. z o. o., Lubeckiego 23A, 60-348 Poznań, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Lisiński', 'Affiliation': 'Department of Rehabilitation and Physiotherapy, University of Medical Sciences, 28 Czerwca 1956 Str., No 135/147, 60-545 Poznań, Poland.'}]","Sensors (Basel, Switzerland)",['10.3390/s20082268']
442,32316391,Short-Communication: Ingestion of a Nucleotide-Rich Mixed Meal Increases Serum Uric Acid Concentrations but Does Not Affect Postprandial Blood Glucose or Serum Insulin Responses in Young Adults.,"Circulating uric acid concentrations have been linked to various metabolic diseases. Consumption of large boluses of nucleotides increases serum uric acid concentrations. We investigated the effect of a nucleotide-rich mixed meal on postprandial circulating uric acid, glucose, and insulin responses. Ten healthy adults participated in a randomised, controlled, double-blind, crossover trial in which they consumed a mixed-meal containing either nucleotide-depleted mycoprotein (L-NU) or high-nucleotide mycoprotein (H-NU) on two separate visits. Blood samples were collected in the postabsorptive state and throughout a 24 h postprandial period, and were used to determine circulating uric acid, glucose, and insulin concentrations. Mixed meal ingestion had divergent effects on serum uric acid concentrations across conditions (time x condition interaction;  P  < 0.001), with L-NU decreasing transiently (from 45 to 240 min postprandially) by ~7% (from 279 ± 16 to 257 ± 14 µmol·L -1 ) and H-NU resulting in a ~12% increase (from 284 ± 13 to 319 ± 12 µmol·L -1  after 210 min), remaining elevated for 12 h and returning to baseline concentrations after 24 h. There were no differences between conditions in blood glucose or serum insulin responses, nor in indices of insulin sensitivity. The ingestion of a nucleotide-rich mixed-meal increases serum uric acid concentrations for ~12 h, but does not influence postprandial blood glucose or serum insulin concentrations.",2020,"P  < 0.001), with L-NU decreasing transiently (from 45 to 240 min postprandially) by ~7% (from 279 ± 16 to 257 ± 14 µmol·L -1 ) and H-NU resulting in a ~12% increase (from 284 ± 13 to 319 ± 12 µmol·L -1  after 210 min), remaining elevated for 12 h and returning to baseline concentrations after 24 h.","['Ten healthy adults', 'Young Adults']","['Nucleotide-Rich Mixed Meal', 'mixed-meal containing either nucleotide-depleted mycoprotein (L-NU) or high-nucleotide mycoprotein (H-NU', 'nucleotide-rich mixed meal']","['serum uric acid concentrations', 'postprandial circulating uric acid, glucose, and insulin responses', 'circulating uric acid, glucose, and insulin concentrations', 'blood glucose or serum insulin responses, nor in indices of insulin sensitivity', 'postprandial blood glucose or serum insulin concentrations']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0028630', 'cui_str': 'Nucleotide'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C2347312', 'cui_str': 'Mycoprotein'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",10.0,0.0304135,"P  < 0.001), with L-NU decreasing transiently (from 45 to 240 min postprandially) by ~7% (from 279 ± 16 to 257 ± 14 µmol·L -1 ) and H-NU resulting in a ~12% increase (from 284 ± 13 to 319 ± 12 µmol·L -1  after 210 min), remaining elevated for 12 h and returning to baseline concentrations after 24 h.","[{'ForeName': 'Mariana O C', 'Initials': 'MOC', 'LastName': 'Coelho', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter EX1 2LU, UK.'}, {'ForeName': 'Alistair J', 'Initials': 'AJ', 'LastName': 'Monteyne', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter EX1 2LU, UK.'}, {'ForeName': 'Ishara D', 'Initials': 'ID', 'LastName': 'Kamalanathan', 'Affiliation': 'UK Research and Innovation, Polaris House, Swindon SN2 1FL, UK.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Najdanovic-Visak', 'Affiliation': 'Chemical Engineering and Applied Chemistry (CEAC), Energy and Bioproducts Research Institute (EBRI), Aston University, Birmingham B4 7ET, UK.'}, {'ForeName': 'Tim J A', 'Initials': 'TJA', 'LastName': 'Finnigan', 'Affiliation': 'Marlow Foods Ltd., Stokesley TS9 7AB, UK.'}, {'ForeName': 'Francis B', 'Initials': 'FB', 'LastName': 'Stephens', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter EX1 2LU, UK.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Wall', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter EX1 2LU, UK.'}]",Nutrients,['10.3390/nu12041115']
443,30101576,Complementary feeding practices among rural Bangladeshi mothers: Results from WASH Benefits study.,"Inappropriate complementary feeding contributes to linear growth faltering in early childhood. Behaviour change interventions have been effective at improving practice, but few studies have investigated the effects of multicomponent integrated interventions. We conducted a cluster-randomized controlled trial in rural Bangladesh in which geographic clusters were randomized into seven arms: water treatment (W), sanitation (S), handwashing (H), water, sanitation, and handwashing (WSH), improved nutrition with infant and young child feeding messages and lipid-based nutrient supplementation for 6- to 24-month olds (N), N+WSH, and control. The objective of this paper was to examine the independent and combined effects of interventions on indicators of complementary feeding. Approximately 1 and 2 years after initiation of the intervention, research assistants surveyed mothers about infant feeding practices. Complementary feeding was examined using the World Health Organization indicators of infant and young child feeding practices. We used Poisson regression models to estimate prevalence ratios and linear regression models for prevalence differences with clustered sandwich estimators to adjust for clustering. A total of 4,718 households from 720 clusters were surveyed at year 1 and 4,667 at year 2. The children in the nutrition arms had a higher prevalence of meeting the minimum dietary diversity score compared with controls (year 1: N: 66.4%; N+WSH: 65.0% vs. C:32.4%; year 2: N: 91.5%; N+WSH: 91.6% vs. C:77.7%). Children in the nutrition arms received diverse food earlier than the children in control arm. In addition, the average consumption of lipid-based nutrient supplementation was >90% in each follow-up. Nutrition-specific interventions could be integrated with nutrition-sensitive interventions such as WSH without compromising the uptake of the nutrition intervention.",2019,The children in the nutrition arms had a higher prevalence of meeting the minimum dietary diversity score compared with controls (year 1: N: 66.4%; N+WSH: 65.0% vs. C:32.4%; year 2: N: 91.5%; N+WSH: 91.6% vs. C:77.7%).,"['rural Bangladesh in which geographic clusters', 'rural Bangladeshi mothers', '4,718 households from 720 clusters were surveyed at year 1 and 4,667 at year 2']","['N+WSH', 'water treatment (W), sanitation (S), handwashing (H), water, sanitation, and handwashing (WSH), improved nutrition with infant and young child feeding messages and lipid-based nutrient supplementation for 6- to 24-month olds (N), N+WSH, and control']","['minimum dietary diversity score', 'average consumption of lipid-based nutrient supplementation']","[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]",4718.0,0.0582974,The children in the nutrition arms had a higher prevalence of meeting the minimum dietary diversity score compared with controls (year 1: N: 66.4%; N+WSH: 65.0% vs. C:32.4%; year 2: N: 91.5%; N+WSH: 91.6% vs. C:77.7%).,"[{'ForeName': 'Kaniz', 'Initials': 'K', 'LastName': 'Jannat', 'Affiliation': 'Environmental Intervention Unit, Infectious Disease Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Medicine - Med/Infectious Diseases, Stanford University, Stanford, California.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Unicomb', 'Affiliation': 'Environmental Intervention Unit, Infectious Disease Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Mahbubur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Environmental Intervention Unit, Infectious Disease Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Winch', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Sarker M', 'Initials': 'SM', 'LastName': 'Parvez', 'Affiliation': 'Environmental Intervention Unit, Infectious Disease Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Kishor K', 'Initials': 'KK', 'LastName': 'Das', 'Affiliation': 'Environmental Intervention Unit, Infectious Disease Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Elli', 'Initials': 'E', 'LastName': 'Leontsini', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Pavani K', 'Initials': 'PK', 'LastName': 'Ram', 'Affiliation': 'Department of Epidemiology and Environmental Health, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California.'}]",Maternal & child nutrition,['10.1111/mcn.12654']
444,32321389,Evaluation of Proactive Community Case Detection to Increase Help Seeking for Mental Health Care: A Pragmatic Randomized Controlled Trial.,"OBJECTIVE


The Community Informant Detection Tool (CIDT) is a vignette- and picture-based method of proactive case detection to promote help seeking for persons with depression, psychosis, alcohol use disorder, and epilepsy. The authors evaluated the effectiveness of the CIDT to increase help-seeking behavior in rural Nepal, where a district mental health care plan was being implemented.
METHODS


Twenty-four health facilities were randomly assigned to one of two methods for training their all-female cadre of community health volunteers: standard training or standard training that included the CIDT. The authors compared the number of patients with depression, psychosis, alcohol use disorder, and epilepsy who were registered in the routine health information system prior to and 6 months after the training.
RESULTS


At health facilities where volunteers received CIDT training, 309 patients were registered as having depression, psychosis, alcohol use disorder, or epilepsy, compared with 182 patients at facilities where volunteers received standard training. The median number of patients registered was 47% greater at facilities where CIDT training was included (24 patients) than at facilities with standard training (16 patients) (p=0.04, r=0.42). The difference in the number of registered patients remained significant when the analysis factored in the population catchment (N=18 patients [CIDT] versus N=14 [standard] per 10,000 population; p=0.05, r=0.40).
CONCLUSIONS


The median number of patients registered as having a mental illness was 47% greater at primary care facilities in which community health volunteers used the CIDT than at facilities where volunteers received standard training. Proactive case finding holds promise for increasing help seeking for mental health care.",2020,The median number of patients registered as having a mental illness was 47% greater at primary care facilities in which community health volunteers used the CIDT than at facilities where volunteers received standard training.,"['309 patients were registered as having depression, psychosis, alcohol use disorder, or epilepsy, compared with 182 patients at facilities where volunteers received', 'Twenty-four health facilities', 'Mental Health Care', 'patients with depression, psychosis, alcohol use disorder, and epilepsy who were registered in the routine health information system prior to and 6 months after the training']","['CIDT training', 'training their all-female cadre of community health volunteers: standard training or standard training that included the CIDT', 'standard training', 'CIDT', 'Proactive Community Case Detection', 'Community Informant Detection Tool (CIDT']","['median number of patients registered', 'median number of patients registered as having a mental illness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0679918', 'cui_str': 'Health Information Systems'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0585825', 'cui_str': 'Patient registered'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",309.0,0.0371716,The median number of patients registered as having a mental illness was 47% greater at primary care facilities in which community health volunteers used the CIDT than at facilities where volunteers received standard training.,"[{'ForeName': 'Mark J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London (Jordans, Lund); Transcultural Psychosocial Organization (TPO) Nepal, Kathmandu (Jordans, Luitel, Kohrt); Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa (Lund); Department of Psychiatry, George Washington University, Washington, D.C. (Kohrt).""}, {'ForeName': 'Nagendra P', 'Initials': 'NP', 'LastName': 'Luitel', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London (Jordans, Lund); Transcultural Psychosocial Organization (TPO) Nepal, Kathmandu (Jordans, Luitel, Kohrt); Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa (Lund); Department of Psychiatry, George Washington University, Washington, D.C. (Kohrt).""}, {'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London (Jordans, Lund); Transcultural Psychosocial Organization (TPO) Nepal, Kathmandu (Jordans, Luitel, Kohrt); Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa (Lund); Department of Psychiatry, George Washington University, Washington, D.C. (Kohrt).""}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Kohrt', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London (Jordans, Lund); Transcultural Psychosocial Organization (TPO) Nepal, Kathmandu (Jordans, Luitel, Kohrt); Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa (Lund); Department of Psychiatry, George Washington University, Washington, D.C. (Kohrt).""}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900377']
445,32321651,Multifocal transcranial stimulation in chronic ischemic stroke: A phase 1/2a randomized trial.,"BACKGROUND AND PURPOSE


Repetitive transcranial magnetic stimulation (rTMS) may promote recovery of motor function after stroke by inducing functional reorganization of cortical circuits. The objective of this study was to examine whether multifocal cortical stimulation using a new wearable transcranial rotating permanent magnet stimulator (TRPMS) can promote recovery of motor function after stroke by inducing functional reorganization of cortical circuits.
METHODS


Thirty 30  patients with chronic ischemic stroke and stable unilateral weakness were enrolled in a Phase 1/2a randomized double-blind sham-controlled clinical trial to evaluate safety and preliminary efficacy. Bilateral hemispheric stimulation was administered for 20 sessions 40 min each over 4 weeks. The primary efficacy endpoint was the change in functional MRI BOLD activation immediately after end of treatment. Secondary efficacy endpoints were clinical scales of motor function, including the Fugl-Meyer motor arm score, ARAT, grip strength, pinch strength, gait velocity, and NIHSS.
RESULTS


TRPMS treatment was well-tolerated with no device-related adverse effects. Active treatment produced a significantly greater increase in the number of active voxels on fMRI than sham treatment (median +48.5 vs -30, p = 0.038). The median active voxel number after active treatment was 8.8-fold greater than after sham (227.5 vs 26, p = 0.016). Although the statistical power was inadequate to establish clinical endpoint benefits, numerical improvements were demonstrated in 5 of 6 clinical scales of motor function. The treatment effects persisted over a 3-month duration of follow-up.
CONCLUSIONS


Multifocal bilateral TRPMS was safe and showed significant fMRI changes suggestive of functional reorganization of cortical circuits in patients with chronic ischemic stroke. A larger randomized clinical trial is warranted to verify recovery of motor function.",2020,"Active treatment produced a significantly greater increase in the number of active voxels on fMRI than sham treatment (median +48.5 vs -30, p = 0.038).","['chronic ischemic stroke', 'Thirty 30  patients with chronic ischemic stroke and stable unilateral weakness', 'patients with chronic ischemic stroke']","['Repetitive transcranial magnetic stimulation (rTMS', 'transcranial rotating permanent magnet stimulator (TRPMS', 'Multifocal transcranial stimulation', 'Bilateral hemispheric stimulation']","['change in functional MRI BOLD activation', 'number of active voxels on fMRI', 'clinical scales of motor function, including the Fugl-Meyer motor arm score, ARAT, grip strength, pinch strength, gait velocity, and NIHSS', 'tolerated with no device-related adverse effects', 'median active voxel number']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C3714552', 'cui_str': 'Debility'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0024483', 'cui_str': 'Magnet'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1264673', 'cui_str': 'Arbitrary rate'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.4372,"Active treatment produced a significantly greater increase in the number of active voxels on fMRI than sham treatment (median +48.5 vs -30, p = 0.038).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chiu', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States. Electronic address: dchiu@houstonmethodist.org.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'McCane', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Blessy', 'Initials': 'B', 'LastName': 'John', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Nguyen', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Butler', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Gadhia', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Misra', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Volpi', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}, {'ForeName': 'Santosh A', 'Initials': 'SA', 'LastName': 'Helekar', 'Affiliation': 'Stanley H. Appel Department of Neurology, Methodist Neurological Institute, Houston Methodist Hospital, 6560 Fannin St #802, Houston, TX 77030, United States.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104816']
446,31012105,A storytelling intervention reduces childhood caries risk behaviors among American Indian and Alaska Native mothers in Northern California.,"OBJECTIVES


To evaluate a storytelling intervention targeting the oral health beliefs, knowledge, and behaviors of AIAN pregnant women and mothers.
METHODS


Fifty-three adult AIAN women from three tribal communities in Northern California participated. The intervention story delivered oral health messaging using a traditional storytelling format. The effect of the intervention on self-reported oral health behaviors, dental knowledge, and beliefs was assessed using a pretest-posttest design, with an additional six-month follow-up. Tests of repeated measures using Generalized Linear Models were conducted to assess changes in oral health knowledge, beliefs, and behaviors.
RESULTS


Knowledge and beliefs significantly increased as a result of the intervention and persisted after six months. A consistent, significant increase in positive oral health behaviors from baseline to six-months was also observed.
CONCLUSIONS


The results of this intervention study suggest promise for traditional storytelling to increase oral health-related knowledge, beliefs, and behaviors among self-identified AIAN pregnant women and mothers.",2019,"The results of this intervention study suggest promise for traditional storytelling to increase oral health-related knowledge, beliefs, and behaviors among self-identified AIAN pregnant women and mothers.","['American Indian and Alaska Native mothers in Northern California', 'pregnant women and mothers', 'Fifty-three adult AIAN women from three tribal communities in Northern California participated']","['storytelling intervention', 'oral health messaging using a traditional storytelling format']","['childhood caries risk behaviors', 'self-reported oral health behaviors, dental knowledge, and beliefs', 'positive oral health behaviors', 'oral health-related knowledge, beliefs, and behaviors', 'oral health knowledge, beliefs, and behaviors']","[{'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0029162'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0029162'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",53.0,0.0386832,"The results of this intervention study suggest promise for traditional storytelling to increase oral health-related knowledge, beliefs, and behaviors among self-identified AIAN pregnant women and mothers.","[{'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Heaton', 'Affiliation': 'Department of Health Policy and Health Services Research, Boston University Henry M. Goldman School of Dental Medicine, Boston, MA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Crawford', 'Affiliation': 'Violence Prevention Research Program, Department of Emergency Medicine, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Wimsatt', 'Affiliation': 'Independent Research Scientist, Sacramento, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Henshaw', 'Affiliation': 'Department of Health Policy and Health Services Research, Boston University Henry M. Goldman School of Dental Medicine, Boston, MA, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Riedy', 'Affiliation': 'Department of Oral Health Policy and Epidemiology, Harvard School of Dental Medicine, Boston, MA, USA.'}, {'ForeName': 'Judith C', 'Initials': 'JC', 'LastName': 'Barker', 'Affiliation': ""Center to Address Disparities in Children's Oral Health (CAN-DO), School of Dentistry, University of California San Francisco, San Francisco, CA, USA.""}, {'ForeName': 'Raul I', 'Initials': 'RI', 'LastName': 'Garcia', 'Affiliation': 'Department of Health Policy and Health Services Research, Boston University Henry M. Goldman School of Dental Medicine, Boston, MA, USA.'}]",Journal of public health dentistry,['10.1111/jphd.12318']
447,31012968,"Maintenance of physical activity and sedentary behavior change, and physical activity and sedentary behavior change after an abridged intervention: Secondary outcomes from the ACTIVATE Trial.","BACKGROUND


This brief report examines the maintenance of moderate to vigorous physical activity (MVPA) and sedentary behavior changes approximately 12 weeks after the delivery of the ACTIVATE Trial primary intervention (use of the Garmin Vivofit 2 activity tracker coupled with a behavioral feedback and goal-setting session and 5 telephone-delivered health coaching sessions). We also examine the efficacy of an abridged intervention (use of the Garmin Vivofit 2 only) in the waitlist control group.
METHODS


A pre-post design was employed to examine the secondary aims of the ACTIVATE Trial (n = 80; mean age = 62 years). MVPA and sedentary behavior were measured using Actigraph and activPAL accelerometers after delivery of the primary intervention (T2), and again 12 weeks later (T3). Linear mixed models with random effects were used to examine within-group changes in MVPA and sitting time variables.
RESULTS


After the 12-week follow-up period, women in the primary intervention group had maintained their higher levels of MVPA (change from T2 to T3 = 14 min/wk; 95% CI = -18 to 46; P = .37). However, their sitting time increased slightly, by 7 min/d (95% CI = -20 to 34; P = .58), but it did not return to its preintervention level. After receiving the Garmin Vivofit 2, the waitlist control group increased their MVPA by 33 min/wk (95% CI = 3-64; P = .03) and reduced their sitting time by 38 min/d (95% CI = -69 to -7; P = .02) over the same 12-week period.
CONCLUSION


The secondary outcomes from the ACTIVATE Trial suggest that wearable technology may generate sustainable changes in MVPA and sitting time. Wearable technology alone may be sufficient to change behavior, at least in the short term.",2019,"After the 12-week follow-up period, women in the primary intervention group had maintained their higher levels of MVPA (change from T2 to T3 = ",['Trial (n\xa0=\xa080; mean age\xa0'],"['Garmin Vivofit 2 activity tracker coupled with a behavioral feedback and goal-setting session and 5 telephone-delivered health coaching sessions', 'abridged intervention']","['MVPA and sitting time variables', 'physical activity and sedentary behavior change, and physical activity and sedentary behavior change', 'levels of MVPA', 'MVPA and sitting time', 'sitting time', 'MVPA and sedentary behavior', 'MVPA']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0428392,"After the 12-week follow-up period, women in the primary intervention group had maintained their higher levels of MVPA (change from T2 to T3 = ","[{'ForeName': 'Brigid M', 'Initials': 'BM', 'LastName': 'Lynch', 'Affiliation': 'Cancer Epidemiology Division, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Nga H', 'Initials': 'NH', 'LastName': 'Nguyen', 'Affiliation': 'Cancer Epidemiology Division, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Moore', 'Affiliation': ""Medical Oncology, St. Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Marina M', 'Initials': 'MM', 'LastName': 'Reeves', 'Affiliation': 'Cancer Prevention Research Centre, School of Public Health, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Dori E', 'Initials': 'DE', 'LastName': 'Rosenberg', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Boyle', 'Affiliation': 'Australian Centre for Precision Health, School of Health Sciences, University of South Australia Cancer Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Shakira', 'Initials': 'S', 'LastName': 'Milton', 'Affiliation': 'Department of General Practice, Melbourne Medical School, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Friedenreich', 'Affiliation': 'Department of Cancer Epidemiology and Prevention Research, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Jeff K', 'Initials': 'JK', 'LastName': 'Vallance', 'Affiliation': 'Faculty of Health Disciplines, Athabasca University, Athabasca, Alberta, Canada.'}, {'ForeName': 'Dallas R', 'Initials': 'DR', 'LastName': 'English', 'Affiliation': 'Cancer Epidemiology Division, Cancer Council Victoria, Melbourne, Victoria, Australia.'}]",Cancer,['10.1002/cncr.32142']
448,31012970,A randomized controlled trial of a wearable technology-based intervention for increasing moderate to vigorous physical activity and reducing sedentary behavior in breast cancer survivors: The ACTIVATE Trial.,"BACKGROUND


The benefits of an active lifestyle after a breast cancer diagnosis are well recognized, but the majority of survivors are insufficiently active. The ACTIVATE Trial examined the efficacy of an intervention (use of the Garmin Vivofit 2 activity monitor coupled with a behavioral feedback and goal-setting session and 5 telephone-delivered health coaching sessions) to increase moderate to vigorous physical activity (MVPA) and reduce sedentary behavior in breast cancer survivors.
METHODS


This randomized controlled trial recruited 83 inactive, postmenopausal women diagnosed with stage I-III breast cancer who had completed primary treatment. Participants were randomly assigned to the intervention group or to the control group, and the intervention was delivered over a 12-week period. MVPA and sedentary behavior were measured with Actigraph and activPAL accelerometers at baseline (T1) and at the end of the intervention (T2).
RESULTS


Retention in the trial was high, with 80 (96%) of participants completing T2 data collection. At T2, there was a significant between-group difference in MVPA (69 min/wk; 95% CI = 22-116) favoring the intervention group. The trial resulted in a statistically significant decrease in both total sitting time and prolonged bouts (≥20 min) of sitting, with between-group reductions of 37 min/d (95% CI = -72 to -2) and 42 min/d (95% CI = -83 to -2), respectively, favoring the intervention group.
CONCLUSION


Results from the ACTIVATE Trial suggest that the use of wearable technology presents an inexpensive and scalable opportunity to facilitate more active lifestyles for cancer survivors. Whether or not such wearable technology-based interventions can create sustainable behavioral change should be the subject of future research.",2019,"The trial resulted in a statistically significant decrease in both total sitting time and prolonged bouts (≥20 min) of sitting, with between-group reductions of 37 min/d (95% CI = -72 to -2) and 42 min/d (95% CI = -83 to -2), respectively, favoring the intervention group.
","['83 inactive, postmenopausal women diagnosed with stage I-III breast cancer who had completed primary treatment', 'breast cancer survivors']","['Garmin Vivofit 2 activity monitor coupled with a behavioral feedback and goal-setting session and 5 telephone-delivered health coaching sessions', 'wearable technology-based intervention']","['MVPA and sedentary behavior', 'total sitting time and prolonged bouts (≥20\xa0min) of sitting', 'MVPA']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4505348', 'cui_str': 'Wearable Electronic Devices'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",83.0,0.125761,"The trial resulted in a statistically significant decrease in both total sitting time and prolonged bouts (≥20 min) of sitting, with between-group reductions of 37 min/d (95% CI = -72 to -2) and 42 min/d (95% CI = -83 to -2), respectively, favoring the intervention group.
","[{'ForeName': 'Brigid M', 'Initials': 'BM', 'LastName': 'Lynch', 'Affiliation': 'Cancer Epidemiology Division, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Nga H', 'Initials': 'NH', 'LastName': 'Nguyen', 'Affiliation': 'Cancer Epidemiology Division, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Moore', 'Affiliation': ""Medical Oncology, St. Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Marina M', 'Initials': 'MM', 'LastName': 'Reeves', 'Affiliation': 'Cancer Prevention Research Centre, School of Public Health, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Dori E', 'Initials': 'DE', 'LastName': 'Rosenberg', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Boyle', 'Affiliation': 'Australian Centre for Precision Health, School of Health Sciences, University of South Australia Cancer Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jeff K', 'Initials': 'JK', 'LastName': 'Vallance', 'Affiliation': 'Faculty of Health Disciplines, Athabasca University, Athabasca, Alberta, Canada.'}, {'ForeName': 'Shakira', 'Initials': 'S', 'LastName': 'Milton', 'Affiliation': 'Department of General Practice, Melbourne Medical School, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Friedenreich', 'Affiliation': 'Department of Cancer Epidemiology and Prevention Research, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Dallas R', 'Initials': 'DR', 'LastName': 'English', 'Affiliation': 'Cancer Epidemiology Division, Cancer Council Victoria, Melbourne, Victoria, Australia.'}]",Cancer,['10.1002/cncr.32143']
449,32250836,"Effect of a brief progressive resistance training program in hospital porters on pain, work ability, and physical function.","BACKGROUND


Hospital porters are possibly exposed to the greatest mechanical loads within the hospital environment. However, the evidence about preventive strategies in this population is scarce.
OBJECTIVE


To investigate the effect of a workplace-based progressive resistance-training program on musculoskeletal pain among hospital porters.
METHOD


A total of 37 hospital porters (27 women, 10 men) participated. Participants allocated to the intervention group performed five brief resistance training sessions/week, for 9 weeks during working hours at the hospital. Intensity was progressively increased. Participants allocated to the control group maintained their usual physical activity. The primary outcome was pain assessed with the patient global impression of pain change scale. Secondary outcome measures were average pain intensity, work ability, use of analgesics, and physical function. Additionally, perceived general changes were evaluated at follow-up: wellness, satisfaction at work, desire to exercise, motivation to eat healthy, energy to be with family and friends, and socialization with colleagues.
RESULTS


For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group. Significant between-group interactions were found for work impairment due to diseases (d = -1.2), hips/thighs pain (d = 0.7), ankles/feet pain (d = 0.4), the Biering-Sorensen test (d = -0.6) and the push-ups test (d = -2.3) favoring the intervention group. All between-group differences were clinically important.
CONCLUSION


A progressive resistance training program performed at the workplace is feasible and effective in reducing musculoskeletal pain and improving work ability and physical function among hospital porters.",2020,"For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group.","['musculoskeletal pain among hospital porters', 'A total of 37 hospital porters (27 women, 10 men) participated']","['workplace-based progressive resistance-training program', 'progressive resistance training program', 'brief resistance training sessions', 'control group maintained their usual physical activity']","['work satisfaction', 'pain assessed with the patient global impression of pain change scale', 'musculoskeletal pain and improving work ability and physical function', 'satisfaction at work, desire to exercise, motivation to eat healthy, energy to be with family and friends, and socialization with colleagues', 'desire for practicing exercise', 'greater wellbeing', 'average pain intensity, work ability, use of analgesics, and physical function', 'ankles/feet pain', 'hips/thighs pain', 'Intensity', 'pain, work ability, and physical function', 'lower general pain']","[{'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0402674', 'cui_str': 'Hospital porter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0016512', 'cui_str': 'Foot pain'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",37.0,0.0521316,"For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group.","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Escriche-Escuder', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain; Department of Physiotherapy, University of Malaga, Malaga, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Calatayud', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain; National Research Centre for the Working Environment, Copenhagen, Denmark. Electronic address: joaquin.calatayud@uv.es.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark; Sport Sciences, Department of Health Science and Technology, Aalborg University, Denmark.'}, {'ForeName': 'Yasmín', 'Initials': 'Y', 'LastName': 'Ezzatvar', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Aiguadé', 'Affiliation': 'Department of Nursing and Physiotherapy, University of Lleida, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Casaña', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102162']
450,32315057,Effect of Intravenous Zoledronic Acid on Tibiofemoral Cartilage Volume Among Patients With Knee Osteoarthritis With Bone Marrow Lesions: A Randomized Clinical Trial.,"Importance


A proof-of-principle study suggested that intravenous zoledronic acid may reduce knee pain and the size of bone marrow lesions in people with knee osteoarthritis, but data from large trials are lacking.
Objective


To determine the effects of intravenous zoledronic acid on knee cartilage volume loss in patients with symptomatic knee osteoarthritis and bone marrow lesions.
Design, Setting, and Participants


A 24-month multicenter, double-blind placebo-controlled randomized clinical trial conducted at 4 sites in Australia (1 research center and 3 hospitals). Adults aged 50 years or older with symptomatic knee osteoarthritis and subchondral bone marrow lesions detected by magnetic resonance imaging (MRI) were enrolled from November 2013 through September 2015. The final date of follow-up was October 9, 2017.
Interventions


Intravenous infusion with either 5 mg of zoledronic acid in a 100-mL saline solution (n = 113) or a placebo saline solution (n = 110) at baseline and 12 months.
Main Outcomes and Measures


The primary outcome was absolute change in tibiofemoral cartilage volume assessed using MRI over 24 months (the minimum clinically important difference [MCID] has not been established). Three prespecified secondary outcomes were change in knee pain assessed by a visual analog scale (0 [no pain] to 100 [unbearable pain]; MCID, 15) and the Western Ontario and McMaster Universities Osteoarthritis Index (0 [no pain] to 500 [unbearable pain]; MCID, 75) over 3, 6, 12, 18, and 24 months and change in bone marrow lesion size over 6 and 24 months (the MCID has not been established).
Results


Of 223 participants enrolled (mean age, 62.0 years [SD, 8.0 years]; 52% were female), 190 (85%) completed the trial. Change in tibiofemoral cartilage volume was not significantly different between the zoledronic acid group and the placebo group over 24 months (-878 mm3 vs -919 mm3; between-group difference, 41 mm3 [95% CI, -79 to 161 mm3]; P = .50). No significant between-group differences were found for any of the prespecified secondary outcomes, including changes in knee pain assessed by a visual analog scale (-11.5 in the zoledronic acid group vs -16.8 in the placebo group; between-group difference, 5.2 [95% CI, -2.3 to 12.8]; P = .17), changes in knee pain assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (-37.5 vs -58.0, respectively; between-group difference, 20.5 [95% CI, -11.2 to 52.2]; P = .21), and changes in bone marrow lesion size (-33 mm2 vs -6 mm2; between-group difference, -27 mm2 [95% CI, -127 to 73 mm2]; P = .60) over 24 months. Adverse events were more common with zoledronic acid than with placebo (96% vs 83%, respectively) and consisted mainly of acute reactions (defined as symptoms within 3 days of administration of infusion; 87% vs 56%).
Conclusions and Relevance


Among patients with symptomatic knee osteoarthritis and bone marrow lesions, yearly zoledronic acid infusions, compared with placebo, did not significantly reduce cartilage volume loss over 24 months. These findings do not support the use of zoledronic acid in the treatment of knee osteoarthritis.
Trial Registration


anzctr.org.au Identifier: ACTRN12613000039785.",2020,"Change in tibiofemoral cartilage volume was not significantly different between the zoledronic acid group and the placebo group over 24 months (-878 mm3 vs -919 mm3; between-group difference, 41 mm3 [95% CI, -79 to 161 mm3]; P = .50).","['4 sites in Australia (1 research center and 3 hospitals', 'people with knee osteoarthritis', 'Adults aged 50 years or older with symptomatic knee osteoarthritis and subchondral bone marrow lesions detected by magnetic resonance imaging (MRI) were enrolled from November 2013 through September 2015', ' 52% were female), 190 (85%) completed the trial', 'Patients With Knee Osteoarthritis With Bone Marrow Lesions', '223 participants enrolled (mean age, 62.0 years [SD, 8.0 years', 'patients with symptomatic knee osteoarthritis and bone marrow lesions']","['Intravenous Zoledronic Acid', 'placebo', 'zoledronic acid infusions', 'zoledronic acid', 'placebo saline solution']","['Adverse events', 'absolute change in tibiofemoral cartilage volume', 'Change in tibiofemoral cartilage volume', 'changes in knee pain assessed by a visual analog scale', 'change in knee pain assessed by a visual analog scale (0 [no pain] to 100 [unbearable pain]; MCID, 15) and the Western Ontario and McMaster Universities Osteoarthritis Index (0', 'knee cartilage volume loss', 'no pain', 'bone marrow lesion size', 'cartilage volume loss', 'Tibiofemoral Cartilage Volume', 'acute reactions', 'knee pain assessed by the Western Ontario and McMaster Universities Osteoarthritis Index']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",223.0,0.637902,"Change in tibiofemoral cartilage volume was not significantly different between the zoledronic acid group and the placebo group over 24 months (-878 mm3 vs -919 mm3; between-group difference, 41 mm3 [95% CI, -79 to 161 mm3]; P = .50).","[{'ForeName': 'Guoqi', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Aitken', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Laslett', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Pelletier', 'Affiliation': 'Osteoarthritis Research Unit, University of Montreal Hospital Research Centre, Notre-Dame Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Martel-Pelletier', 'Affiliation': 'Osteoarthritis Research Unit, University of Montreal Hospital Research Centre, Notre-Dame Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': 'Queen Elizabeth Hospital, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'March', 'Affiliation': 'University of Sydney, Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Anita E', 'Initials': 'AE', 'LastName': 'Wluka', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Antony', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Blizzard', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Winzenberg', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Cicuttini', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Jones', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia.'}]",JAMA,['10.1001/jama.2020.2938']
451,32316559,Ex-Vivo Comparison of Torsional Stress on Nickel-Titanium Instruments Activated by Continuous Rotation or Adaptive Motion.,"This study aimed to evaluate the effect of adaptive motion applied to conventional nickel-titanium (NiTi) rotary instruments on torsional stress generation during shaping procedure. One hundred and twenty mesio-buccal canals of molars were randomly assigned to two groups according to the kinetics; adaptive motion (AD) and continuous rotation (CR). Each group was divided into four subgroups (n = 15) according to the NiTi instrument systems: HyFlex EDM, One Curve, Twisted File Adaptive, and ProTaper Next. A glide path was established with PathFile #1, for each file group being used with either of the kinetic movements. During the instrumentation with the designated motion and file system, the generated torque was measured via the control unit and acquisition module. Based on the acquired data, the maximum and total torque were calculated. The data were statistically analyzed using Kruskal-Wallis and Mann-Whitney tests at a significance level of 95%. The maximum and total torque generated by all instruments were significantly reduced by the adaptive motion ( p  < 0.05). In the CR group, HyFlex EDM generated the highest maximum and total stress. In the AD group, HyFlex EDM showed the highest maximum torsional stress, and One Curve showed the highest total torsional stress ( p  < 0.05). The TF Adaptive instrument with adaptive movement produced the lowest maximum and total torsional stress ( p  < 0.05). Under the conditions of this study, the use of adaptive motion would be useful to reduce the torsional stress of instrument and root dentin. The reduction of torsional stress through adaptive motion may enhance the durability of instruments and reduce the potential risk of dentinal cracks.",2020,The TF Adaptive instrument with adaptive movement produced the lowest maximum and total torsional stress ( p  < 0.05).,['One hundred and twenty mesio-buccal canals of molars'],"['kinetics; adaptive motion (AD) and continuous rotation (CR', 'adaptive motion applied to conventional nickel-titanium (NiTi) rotary instruments', 'NiTi instrument systems: HyFlex EDM, One Curve, Twisted File Adaptive, and ProTaper']","['maximum and total torque', 'highest maximum and total stress', 'highest total torsional stress', 'highest maximum torsional stress', 'torsional stress generation', 'lowest maximum and total torsional stress', 'Kruskal-Wallis and Mann-Whitney tests', 'torsional stress of instrument and root dentin']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0016094', 'cui_str': 'Filing'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0450425', 'cui_str': 'Torsional'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]",,0.0182421,The TF Adaptive instrument with adaptive movement produced the lowest maximum and total torsional stress ( p  < 0.05).,"[{'ForeName': 'Joo Yeong', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Conservative Dentistry, Dental Research Institute, School of Dentistry, Pusan National University, Yangsan 50612, Korea.'}, {'ForeName': 'Sang Won', 'Initials': 'SW', 'LastName': 'Kwak', 'Affiliation': 'Department of Conservative Dentistry, Dental Research Institute, School of Dentistry, Pusan National University, Yangsan 50612, Korea.'}, {'ForeName': 'Jung-Hong', 'Initials': 'JH', 'LastName': 'Ha', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Kyungpook National University, Daegu 41940, Korea.'}, {'ForeName': 'Hyeon-Cheol', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, Dental Research Institute, School of Dentistry, Pusan National University, Yangsan 50612, Korea.'}]","Materials (Basel, Switzerland)",['10.3390/ma13081900']
452,32316561,"Four Weeks of Time-Restricted Feeding Combined with Resistance Training Does Not Differentially Influence Measures of Body Composition, Muscle Performance, Resting Energy Expenditure, and Blood Biomarkers.","Recently, interest in time-restricted feeding (TRF) has increased from reports highlighting improvements in body composition and muscular performance measures. Twenty-six recreationally active males were randomly assigned to either TRF ( n  = 13; ~22.9 years; 82.0 kg; 178.1 cm; 8 h eating window, 25% caloric deficit, 1.8 g/kg/day protein) or normal diet (ND;  n  = 13; ~22.5 years; 83.3 kg; 177.5 cm; normal meal pattern; 25% caloric deficit, 1.8 g/kg/day protein) groups. Participants underwent 4-weeks of supervised full body resistance training. Changes in body composition (fat mass (FM), fat free mass (FFM), and body fat percentage (BF%)), skeletal muscle cross sectional area (CSA) and muscle thickness (MT) of the vastus lateralis (VL), rectus femoris, (RF), and biceps brachii (BB) muscles, resting energy expenditure (REE), muscular performance, blood biomarkers, and psychometric parameters were assessed. Significant ( p  < 0.05) decreases were noted in BM, FM, BF%, testosterone, adiponectin, and REE, along with significant increases in BP 1RM , LP 1RM , VJ HT , VJ PP , VL CSA , BB CSA , and BB MT  in both groups. Plasma cortisol levels were significantly elevated at post ( p  = 0.018) only in ND. Additionally, FFM was maintained equally between groups. Thus, a TRF style of eating does not enhance reductions in FM over caloric restriction alone during a 4-week hypocaloric diet.",2020,"Significant ( p  < 0.05) decreases were noted in BM, FM, BF%, testosterone, adiponectin, and REE, along with significant increases in BP 1RM , LP 1RM , VJ HT , VJ PP , VL CSA , BB CSA , and BB MT  in both groups.",['Twenty-six recreationally active males'],"['FFM', 'TRF', 'supervised full body resistance training']","['body composition (fat mass (FM), fat free mass (FFM), and body fat percentage (BF%)), skeletal muscle cross sectional area (CSA) and muscle thickness (MT) of the vastus lateralis (VL), rectus femoris, (RF), and biceps brachii (BB) muscles, resting energy expenditure (REE), muscular performance, blood biomarkers, and psychometric parameters', 'Plasma cortisol levels', 'BM, FM, BF%, testosterone, adiponectin, and REE', 'Body Composition, Muscle Performance, Resting Energy Expenditure, and Blood Biomarkers', 'BP 1RM , LP 1RM , VJ HT , VJ PP , VL CSA , BB CSA , and BB MT']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]",26.0,0.0268502,"Significant ( p  < 0.05) decreases were noted in BM, FM, BF%, testosterone, adiponectin, and REE, along with significant increases in BP 1RM , LP 1RM , VJ HT , VJ PP , VL CSA , BB CSA , and BB MT  in both groups.","[{'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Stratton', 'Affiliation': 'Department of Exercise Science and Sport Management, Kennesaw State University, Kennesaw, GA 30144, USA.'}, {'ForeName': 'Grant M', 'Initials': 'GM', 'LastName': 'Tinsley', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX 79409, USA.'}, {'ForeName': 'Michaela G', 'Initials': 'MG', 'LastName': 'Alesi', 'Affiliation': 'Department of Exercise Science and Sport Management, Kennesaw State University, Kennesaw, GA 30144, USA.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Hester', 'Affiliation': 'Department of Exercise Science and Sport Management, Kennesaw State University, Kennesaw, GA 30144, USA.'}, {'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Olmos', 'Affiliation': 'Department of Exercise Science and Sport Management, Kennesaw State University, Kennesaw, GA 30144, USA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Serafini', 'Affiliation': 'Department of Exercise Science and Sport Management, Kennesaw State University, Kennesaw, GA 30144, USA.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Modjeski', 'Affiliation': 'Department of Exercise Science and Sport Management, Kennesaw State University, Kennesaw, GA 30144, USA.'}, {'ForeName': 'Gerald T', 'Initials': 'GT', 'LastName': 'Mangine', 'Affiliation': 'Department of Exercise Science and Sport Management, Kennesaw State University, Kennesaw, GA 30144, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'King', 'Affiliation': 'Department of Exercise Science and Sport Management, Kennesaw State University, Kennesaw, GA 30144, USA.'}, {'ForeName': 'Shelby N', 'Initials': 'SN', 'LastName': 'Savage', 'Affiliation': 'Department of Exercise Science and Sport Management, Kennesaw State University, Kennesaw, GA 30144, USA.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Webb', 'Affiliation': 'Department of Exercise Science and Sport Management, Kennesaw State University, Kennesaw, GA 30144, USA.'}, {'ForeName': 'Trisha A', 'Initials': 'TA', 'LastName': 'VanDusseldorp', 'Affiliation': 'Department of Exercise Science and Sport Management, Kennesaw State University, Kennesaw, GA 30144, USA.'}]",Nutrients,['10.3390/nu12041126']
453,32316589,"Iron Status in Elderly Women Impacts Myostatin, Adiponectin and Osteocalcin Levels Induced by Nordic Walking Training.","Impaired iron metabolism is associated with increased risk of many morbidities. Exercise was shown to have a beneficial role; however, the mechanism is not well understood. The purpose of this study was to assess the relationship between exerkines and iron metabolism in elderly women before and after 12 weeks of Nordic Walking (NW) training. Exerkines like myostatin, adiponectin, and osteocalcin have been shown to have several positive effects on metabolism. Thirty-six post-menopausal women (66 ± 5 years old, mean ± SD) were randomly assigned to a NW intervention group (n = 18; body mass, 68.8 ± 11.37 kg; fat, 23.43 ± 7.5 kg; free fat mass, 45.37 ± 5.92 kg) or a control group (n = 18; body mass, 68.34 ± 11.81 kg; fat, 23.61 ± 10.03 kg; free fat mass, 44.73 ± 3.9 kg). The training was performed three times a week for 12 weeks, with the intensity adjusted to 70% of the individual maximum ability. Before and one day after the 12-weeks intervention, performance indices were assessed using a senior fitness test. Blood samples (5 mL) were obtained from the participants between 7 and 8 AM, following an overnight fast, at baseline and one day immediately after the 12-week training program. A significant and large time ´ group interaction was observed for iron (NW: 98.6 ± 26.68 to 76.1 ± 15.31; CON: 100.6 ± 25.37 to 99.1 ± 27.2;  p  = 0.01; = 0.21), myostatin (NW: 4.42 ± 1.97 to 3.83 ± 1.52; CON: 4.11 ± 0.95 to 4.84 ± 1.19;  p  = 0.00; = 0.62), adiponectin (NW: 12.0 ± 9.46 to 14.6 ± 10.64; CON: 12.8 ± 8.99 to 11.9 ± 8.53;  p  = 0.00; = 0.58), and osteocalcin (NW: 38.9 ± 26.04 to 41.6 ± 25.09; CON: 37.1 ± 33.2 to 37.2 ± 32.29;  p  = 0.03; = 0.13). Furthermore, we have observed the correlations: basal ferritin levels were inversely correlated with changes in myostatin ( r  = -0.51,  p  = 0.05), change in adiponectin, and change in serum iron ( r  = -0.45,  p  = 0.05), basal iron, and osteocalcin after training ( r  = -0.55,  p  = 0.04). These findings indicate that iron modulates NW training-induced changes in exerkine levels.",2020,"A significant and large time ´ group interaction was observed for iron (NW: 98.6 ± 26.68 to 76.1 ± 15.31; CON: 100.6 ± 25.37 to 99.1 ± 27.2;  p  = 0.01; = 0.21), myostatin (NW: 4.42 ± 1.97 to 3.83 ± 1.52; CON: 4.11 ± 0.95 to 4.84 ± 1.19;  ","['Thirty-six post-menopausal women (66 ± 5 years old, mean ± SD', 'elderly women before and after 12 weeks of Nordic Walking (NW) training']",[],"['change in adiponectin, and change in serum iron', 'correlations: basal ferritin levels', 'Adiponectin and Osteocalcin Levels', 'basal iron, and osteocalcin', 'exerkine levels']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}]",,0.0728038,"A significant and large time ´ group interaction was observed for iron (NW: 98.6 ± 26.68 to 76.1 ± 15.31; CON: 100.6 ± 25.37 to 99.1 ± 27.2;  p  = 0.01; = 0.21), myostatin (NW: 4.42 ± 1.97 to 3.83 ± 1.52; CON: 4.11 ± 0.95 to 4.84 ± 1.19;  ","[{'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Kortas', 'Affiliation': 'Department of Sport, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Ziemann', 'Affiliation': 'Department of Athletics, Strength and Conditioning, Poznan University of Physical Education, 61-871 Poznan, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Juszczak', 'Affiliation': 'Seventh Navy Hospital, 80-305 Gdansk, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Micielska', 'Affiliation': 'Department of Anatomy and Anthropology, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Kozłowska', 'Affiliation': 'Department of Physiology and Pharmacology, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Prusik', 'Affiliation': 'Department of Sport, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Prusik', 'Affiliation': 'Department of Sport, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Jedrzej', 'Initials': 'J', 'LastName': 'Antosiewicz', 'Affiliation': 'Department of Bioenergetics and Physiology of Exercise, Medical University of Gdansk, 80-210 Gdansk, Poland.'}]",Nutrients,['10.3390/nu12041129']
454,32317212,"Acceptability, safety, and feasibility of in-bed cycling with critically ill patients.","BACKGROUND


In-bed cycling is a promising intervention that may assist critically ill patients to maintain muscle mass and improve their trajectory of recovery. The acceptability of in-bed cycling from the different perspectives of patients, clinicians, and families are unknown. In addition, the safety and feasibility of in-bed cycling in an Australian tertiary intensive care unit (ICU) is relatively unknown.
OBJECTIVES


The objective of this study was to examine the acceptability, safety, and feasibility of in-bed cycling in an Australian tertiary, adult, mixed medical, surgical, trauma ICU.
METHODS


An observational process evaluation was embedded in one arm of a two-arm parallel phase II randomised controlled trial that was conducted in an Australian tertiary ICU. The process evaluation was of the acceptability, safety, and feasibility of passive and active in-bed cycling for participants allocated to the trial intervention group. In-bed cycling acceptability questionnaires were designed through a three-step Delphi process. Questionnaire responses from patients, family members, and clinicians who participated in or observed the intervention during the Critical Care Cycling Study (CYCLIST) were evaluated to determine the acceptability of in-bed cycling. The congruence of responses between respondents was also compared. Safety and feasibility of the in-bed cycling intervention were assessed against predetermined criteria.
RESULTS


Acceptability questionnaire responses demonstrated that in-bed cycling was an acceptable intervention from the perspectives of patients, family members, and clinicians. Questionnaire responses were congruent across the respondent groups. Safety was demonstrated with two minor transient adverse events occurring during 276 in-bed cycling sessions (adverse event rate: 0.7%). In-bed cycling sessions were feasible with 276 of 304 (90%) planned sessions conducted.
CONCLUSIONS


Acceptability questionnaire responses found that in-bed cycling was regarded as an acceptable intervention to patients, family members, and clinicians. The implementation of in-bed cycling was safe and feasible to complete with critically ill patients during the early stages of their critical illness in an Australian tertiary ICU setting.",2020,Safety was demonstrated with two minor transient adverse events occurring during 276 in-bed cycling sessions (adverse event rate: 0.7%).,"['critically ill patients', 'patients, family members, and clinicians who participated in\xa0or observed the intervention during the Critical Care Cycling Study (CYCLIST', 'critically ill patients during the early stages of their critical illness in an Australian tertiary ICU setting', 'Australian tertiary intensive care unit (ICU']",[],"['Acceptability, safety, and feasibility', 'Acceptability questionnaire responses', 'safety and feasibility', 'Questionnaire responses', 'acceptability, safety, and feasibility', 'acceptability, safety, and feasibility of passive and active']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",,0.0553266,Safety was demonstrated with two minor transient adverse events occurring during 276 in-bed cycling sessions (adverse event rate: 0.7%).,"[{'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Nickels', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Australian Centre for Health Services Innovation and Centre for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia; Centre for Functioning and Health Research, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: marc.nickels@health.qld.gov.au.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Aitken', 'Affiliation': 'School of Health Sciences, City, University of London, London, United Kingdom; Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia. Electronic address: leanne.aitken.1@city.ac.uk.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Barnett', 'Affiliation': 'Australian Centre for Health Services Innovation and Centre for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia. Electronic address: a.barnett@qut.edu.au.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Walsham', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; School of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: james.walsham@health.qld.gov.au.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'Australian Centre for Health Services Innovation and Centre for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia; Centre for Functioning and Health Research, Metro South Health, Brisbane, Queensland, Australia; Clinical Informatics, Metro South Health, Brisbane, Australia. Electronic address: steven.mcphail@qut.edu.au.'}]",Australian critical care : official journal of the Confederation of Australian Critical Care Nurses,['10.1016/j.aucc.2020.02.007']
455,31611333,Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Survivors: A Randomized Controlled Pilot Trial.,"BACKGROUND


Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating long-term side effects in breast cancer survivors. We conducted a randomized controlled pilot trial to assess the feasibility, safety, and effects of an acupuncture intervention on CIPN in this population.
PATIENTS AND METHODS


Women with stage I-III breast cancer with grade 1 or higher CIPN after taxane-containing adjuvant chemotherapy were randomized 1:1 to an immediate acupuncture (IA) arm or to a waitlist control group (CG). Participants in the IA arm received 18 sessions of acupuncture over 8 weeks, then received no additional acupuncture. Patients in the CG arm received usual care over 8 weeks, followed by nine sessions of acupuncture over 8 weeks. Measures including Patient Neurotoxicity Questionnaire (PNQ), Functional Assessment of Cancer Therapy-Neurotoxicity subscale (FACT-NTX), and Brief Pain Inventory-short form (BPI-SF) were collected at baseline and at 4, 8, and 16 weeks after enrollment.
RESULTS


Forty women (median age, 54) were enrolled (20 to IA and 20 to CG), with median time between completion of chemotherapy and enrollment of 14 months (range 1-92). At 8 weeks, participants in the IA arm experienced significant improvements in PNQ sensory score (-1.0 ± 0.9 vs. -0.3 ± 0.6;  p  = .01), FACT-NTX summary score (8.7 ± 8.9 vs. 1.2 ± 5.4;  p  = .002), and BPI-SF pain severity score (-1.1 ± 1.7 vs. 0.3 ± 1.5;  p  = .03), compared with those in the CG arm. No serious side effects were observed.
CONCLUSION


Women with CIPN after adjuvant taxane therapy for breast cancer experienced significant improvements in neuropathic symptoms from an 8-week acupuncture treatment regimen. Additional larger studies are needed to confirm these findings.
IMPLICATIONS FOR PRACTICE


Chemotherapy-induced peripheral neuropathy (CIPN) is a toxicity that often persists for months to years after the completion of adjuvant chemotherapy for early breast cancer. In a randomized pilot trial of 40 breast cancer survivors with CIPN, an 8-week acupuncture intervention (vs. usual care) led to a statistically and clinically significant improvement in subjective sensory symptoms including neuropathic pain and paresthesia. Given the lack of effective therapies and established safety profile of acupuncture, clinicians may consider acupuncture as a treatment option for mild to moderate CIPN in practice.",2019,"No serious side effects were observed.
","['breast cancer survivors', '40 breast cancer survivors with CIPN, an 8-week', 'Forty women (median age, 54) were enrolled (20 to IA and 20 to CG), with median time between completion of chemotherapy and enrollment of 14 months (range 1-92', 'Breast Cancer Survivors', 'Women with stage I-III breast cancer with grade 1 or higher CIPN after']","['acupuncture', 'immediate acupuncture (IA) arm or to a waitlist control group (CG', 'taxane therapy', 'taxane-containing adjuvant chemotherapy', 'acupuncture intervention', 'Acupuncture']","['neuropathic symptoms', 'BPI-SF pain severity score', 'PNQ sensory score', 'Patient Neurotoxicity Questionnaire (PNQ), Functional Assessment of Cancer Therapy-Neurotoxicity subscale (FACT-NTX), and Brief Pain Inventory-short form (BPI-SF', 'serious side effects', 'subjective sensory symptoms including neuropathic pain and paresthesia']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0423551', 'cui_str': 'Sensory symptoms (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}]",40.0,0.156072,"No serious side effects were observed.
","[{'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA weidong_lu@dfci.harvard.edu.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Giobbie-Hurder', 'Affiliation': 'Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Freedman', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Im Hee', 'Initials': 'IH', 'LastName': 'Shin', 'Affiliation': 'Department of Medical Statistics and Informatics, School of Medicine at the Catholic University of Daegu, Daegu, Republic of Korea.'}, {'ForeName': 'Nancy U', 'Initials': 'NU', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Ligibel', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0489']
456,32311204,Long-term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT-2 study): 52-week results from a randomized controlled trial.,"AIM


To investigate the long-term efficacy and safety of dapagliflozin as an adjunct to adjustable insulin in adults with type 1 diabetes (T1D) and inadequate glycaemic control.
MATERIALS AND METHODS


Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes (DEPICT-2) was a placebo-controlled, double-blind, multicentre, phase III study of adults with T1D (HbA1c 7.5%-10.5%) randomized (1:1:1) to receive dapagliflozin 5, 10 mg, or placebo. The efficacy and safety of dapagliflozin over 52 weeks were exploratory endpoints in this extension to DEPICT-2.
RESULTS


Of 813 participants randomized, 88.2% completed the study. From baseline to 52 weeks, dapagliflozin 5 and 10 mg were associated with reduction in HbA1c (difference [95% CI] vs. placebo: -0.20% [-0.34, -0.06] and -0.25% [-0.38, -0.11], respectively) and adjusted mean percentage change in body weight (difference [95% CI] vs. placebo: -4.42% [-5.19, -3.64] and -4.86% [-5.63, -4.08], respectively). Serious adverse events were reported in the dapagliflozin 5, 10 mg, and placebo groups (32 [11.8%], 19 [7.0%] and 16 [5.9%], respectively). The proportion of hypoglycaemic events was similar across groups; severe hypoglycaemia was uncommon. More participants with events adjudicated as definite diabetic ketoacidosis (DKA) were in the dapagliflozin 5 and 10 mg groups versus placebo (11 [4.1%], 10 [3.7%] and 1 [0.4%], respectively); the majority of events were mild or moderate in severity and all were resolved with treatment.
CONCLUSIONS


Dapagliflozin led to long-term reductions in HbA1c and body weight in adults with T1D, but increased DKA risk compared with placebo.",2020,"From baseline to 52 weeks, dapagliflozin 5 and 10 mg were associated with reduction in HbA 1c  (difference [95% CI] vs. placebo: -0.20% [-0.34, -0.06] and - 0.25% [-0.38, -0.11], respectively) and adjusted mean percentage change in body weight (difference [95% CI] vs. placebo: -4.42% [-5.19, -3.64], and - 4.86% [-5.63, -4.08], respectively).","['813 participants randomized, 88.2% completed the study', 'adults with type 1 diabetes (T1D) and inadequate glycemic control', 'DEPICT-2 (Dapagliflozin Evaluation in Patients with Inadequately Controlled T1D; NCT02460978) was a placebo-controlled, double-blind, multicenter, Phase III study of adults with T1D (HbA 1c  7.5-10.5', 'patients with inadequately controlled type 1 diabetes (the DEPICT-2 study']","['dapagliflozin 5\u2009mg, 10\u2009mg, or placebo', 'dapagliflozin', 'Dapagliflozin', 'placebo']","['definite diabetic ketoacidosis (DKA', 'proportion of hypoglycemic events', 'HbA 1c  and body weight', 'Serious adverse events', 'efficacy and safety', 'DKA risk', 'reduction in HbA 1c', 'severe hypoglycemia', 'body weight']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C3709923', 'cui_str': 'dapagliflozin 5 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}]",813.0,0.500435,"From baseline to 52 weeks, dapagliflozin 5 and 10 mg were associated with reduction in HbA 1c  (difference [95% CI] vs. placebo: -0.20% [-0.34, -0.06] and - 0.25% [-0.38, -0.11], respectively) and adjusted mean percentage change in body weight (difference [95% CI] vs. placebo: -4.42% [-5.19, -3.64], and - 4.86% [-5.63, -4.08], respectively).","[{'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Clinical and Experimental Endocrinology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Gottfried', 'Initials': 'G', 'LastName': 'Rudofsky', 'Affiliation': 'Endocrinology and Metabolic Diseases, Cantonal Hospital Olten, Olten, Switzerland.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""Institute for Endocrinology and Diabetes, Schneider Children's Medical Center of Israel, Tel-Aviv University, Tel-Aviv, Israel.""}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Araki', 'Affiliation': 'Department of Metabolic Medicine, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Arya', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Thorén', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Scheerer', 'Affiliation': 'BioPharmaceuticals Medical, AstraZeneca, Wedel, Germany.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Dandona', 'Affiliation': 'Department of Endocrinology, Kaleida Health, Buffalo, New York, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14060']
457,32105984,"Rationale and design for a multicenter, randomized, double-blind, placebo-controlled, phase 2 study evaluating the safety and efficacy of the soluble guanylate cyclase stimulator praliciguat over 12 weeks in patients with heart failure with preserved ejection fraction (CAPACITY HFpEF).","BACKGROUND


Heart failure with preserved ejection fraction (HFpEF) is a significant cause of morbidity and mortality worldwide. Exercise intolerance is the main symptom of HFpEF and is associated with a poor quality of life and increased mortality. Currently, there are no approved medications for the treatment of HFpEF. Praliciguat (IW-1973), a novel soluble guanylate cyclase stimulator that may help restore deficient nitric oxide-soluble guanylate cyclase-cyclic guanosine 3',5'-monophosphate signaling, is being investigated for the treatment of patients with HFpEF.
METHODS


CAPACITY HFpEF is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the safety and efficacy of praliciguat over 12 weeks in approximately 184 patients with HFpEF. Eligible patients must have evidence supporting clinical HFpEF and at least 2 of the following 4 conditions associated with NO deficiency: diabetes/prediabetes, hypertension, obesity, and age >70 years. The primary efficacy end point is the change from baseline in peak VO 2  by cardiopulmonary exercise test (CPET). Secondary end points include the change from baseline in 6-minute walk test distance and the change in ventilatory efficiency on CPET, as well as number of CPET responders. Other exploratory end points include changes in echocardiographic parameters, New York Heart Association functional classification, cardiac events, blood and urine biomarkers pathophysiologically relevant to heart failure, and patient-reported outcomes including Kansas City Cardiomyopathy Questionnaire.
CONCLUSIONS


The CAPACITY HFpEF trial will provide data on short-term safety and efficacy of praliciguat on peak exercise capacity, as well as multiple secondary end points of submaximal functional capacity, patient-reported outcomes, and biomarkers.",2020,"Praliciguat (IW-1973), a novel soluble guanylate cyclase stimulator that may help restore deficient nitric oxide-soluble guanylate cyclase-cyclic guanosine 3',5'-monophosphate signaling, is being investigated for the treatment of patients with HFpEF.
","['184 patients with HFpEF', 'patients with HFpEF', 'Eligible patients must have evidence supporting clinical HFpEF and at least 2 of the following 4 conditions associated with NO deficiency: diabetes/prediabetes, hypertension, obesity, and age >70\u202fyears', 'patients with heart failure with preserved ejection fraction (CAPACITY HFpEF']","['placebo', 'soluble guanylate cyclase stimulator praliciguat', 'HFpEF']","['echocardiographic parameters, New York Heart Association functional classification, cardiac events, blood and urine biomarkers pathophysiologically relevant to heart failure, and patient-reported outcomes including Kansas City Cardiomyopathy Questionnaire', 'safety and efficacy', 'peak VO 2  by cardiopulmonary exercise test (CPET', '6-minute walk test distance and the change in ventilatory efficiency on CPET, as well as number of CPET responders']","[{'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1097411', 'cui_str': 'Soluble Guanylate Cyclase'}, {'cui': 'C0175727', 'cui_str': 'Stimulator, device (physical object)'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005768'}, {'cui': 'C0042037'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",184.0,0.38256,"Praliciguat (IW-1973), a novel soluble guanylate cyclase stimulator that may help restore deficient nitric oxide-soluble guanylate cyclase-cyclic guanosine 3',5'-monophosphate signaling, is being investigated for the treatment of patients with HFpEF.
","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Udelson', 'Affiliation': 'Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, MA. Electronic address: JUdelson@tuftsmedicalcenter.org.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and the RHJ Department of Veterans Affairs Medical Center, Charleston, SC.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Burnett', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mittleman', 'Affiliation': 'Cyclerion Therapeutics, Cambridge, MA.'}, {'ForeName': 'Albert T', 'Initials': 'AT', 'LastName': 'Profy', 'Affiliation': 'Cyclerion Therapeutics, Cambridge, MA.'}, {'ForeName': 'Jelena P', 'Initials': 'JP', 'LastName': 'Seferovic', 'Affiliation': 'Cyclerion Therapeutics, Cambridge, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reasner', 'Affiliation': 'Ironwood Pharmaceuticals, Cambridge, MA.'}, {'ForeName': 'Marvin A', 'Initials': 'MA', 'LastName': 'Konstam', 'Affiliation': 'Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, MA.'}]",American heart journal,['10.1016/j.ahj.2020.01.009']
458,30677175,Theory-based diabetes self-management education with pre-selection of participants: a randomized controlled trial with 2.5 years' follow-up (ELDES Study).,"AIMS


To evaluate the (cost-)effectiveness of Beyond Good Intentions (BGI), a 12-week group-based, nurse-led self-management programme, in terms of cardiovascular risk factors, self-management and quality of life, after 2.5 years of follow-up in pre-selected individuals with known Type 2 diabetes of up to 5 years' duration.
METHODS


A parallel randomized controlled trial comparing BGI with usual care, based on a self-management screening questionnaire, was conducted in 43 general practices after pre-selection of participants. After 2.5 years of follow-up, the between-group changes in the abovementioned variables were assessed using analysis of covariance.
RESULTS


A total of 108 participants (BGI group, n =56; control group, n =52) were included. Changes over time in BMI (-0.4 vs -0.5 kg/m 2  ) were similar in the two groups. Median HbA 1c  [BGI group 47 mmol/mol (6.5%); control group: 49 mmol/mol (6.6%)] and mean systolic blood pressure (BGI group: 132±13 mmHg; control group: 133±14 mmHg) were well controlled at baseline and no intervention effect was found. LDL cholesterol levels decreased from 2.4 to 2.2 mmol/l in the control group and remained stable at 2.6 mmol/l in the intervention group (P=0.032). No intervention effect was found for self-management or quality of life.
CONCLUSION


In contrast to the first BGI study, we did not observe significant effects of the BGI intervention, despite pre-selection of individuals. In diabetes populations with target levels for HbA 1c  , systolic blood pressure and LDL cholesterol, no further beneficial effects can be expected from self-management programmes with regard to biomedical factors and quality of life.",2019,"No intervention effect was found for self-management or quality of life.
","['108 participants (BGI group, n =56; control group, n =52) were included', '43 general practices after pre-selection of participants', ""pre-selected individuals with known Type 2 diabetes of up to 5 years' duration""]",[],"['self-management or quality of life', 'Changes over time in BMI', 'systolic blood pressure and LDL cholesterol', 'cardiovascular risk factors, self-management and quality of life', 'mean systolic blood pressure', 'LDL cholesterol levels']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",[],"[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0034380'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",108.0,0.0400274,"No intervention effect was found for self-management or quality of life.
","[{'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Vos', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, Department of General Practice, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'van Heusden', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, Department of General Practice, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'N W D', 'Initials': 'NWD', 'LastName': 'Eikelenboom', 'Affiliation': 'DOH Care Group, Eindhoven, The Netherlands.'}, {'ForeName': 'G E H M', 'Initials': 'GEHM', 'LastName': 'Rutten', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, Department of General Practice, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.13907']
459,32223044,"Monomeric Flavanols Are More Efficient Substrates for Gut Microbiota Conversion to Hydroxyphenyl-γ-Valerolactone Metabolites Than Oligomeric Procyanidins: A Randomized, Placebo-Controlled Human Intervention Trial.","SCOPE


The majority of ingested flavanols reach the colon where they are catabolized by the microbiota to form hydroxyphenyl-γ-valerolactones (HGVLs). It is not known if the HGVLs are catabolic products of monomeric (epi)catechins (EPC), oligomeric procyanidins (OPCs), or both. Using data from a randomized, double-blind, placebo-controlled crossover trial the relative contributions of catechins and OPC to the bioavailable pool of HGVLs are estimated.
METHODS AND RESULTS


Participants ingested an apple extract once daily for 28 days that delivered the following: i) 70 mg EPC and 65 mg OPC (low dose EPC), ii) 140 mg EPC and 130 mg OPC (high dose EPC), iii) 6 mg EPC and 130 mg OPC (OPC), and iv) a placebo control. Urine is collected over a 24-h period before and after treatments. The median urinary excretion of HGVLs after ingestion of the high dose EPC is tenfold higher than that excreted after ingestion of the OPC that provided an equivalent dose of PC. Approximately 22% of catechins are converted to HGVLs in contrast to PC, for which there is limited conversion.
CONCLUSION


Monomeric catechins are efficiently converted to derived HGVLs that are absorbed and excreted in human urine, whereas oligomeric PCs are much less efficiently converted.",2020,The median urinary excretion of HGVL metabolites after ingestion of the high dose EPC was 10-fold higher than that excreted after ingestion of the OPC that provided an equivalent dose of PC.,['Participants ingested an apple extract once daily for 28-d that delivered the following: (i) 70\xa0mg'],"['catechins and 65\xa0mg PC (Low dose EPC', 'Placebo', 'placebo']",['median urinary excretion of HGVL metabolites'],"[{'cui': 'C3257517', 'cui_str': 'Apple extract'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0169014', 'cui_str': 'erucylphosphocholine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.455696,The median urinary excretion of HGVL metabolites after ingestion of the high dose EPC was 10-fold higher than that excreted after ingestion of the OPC that provided an equivalent dose of PC.,"[{'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Hollands', 'Affiliation': 'Food Innovation and Health Programme, Quadram Institute Bioscience, Norwich, NR4 7UQ, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Philo', 'Affiliation': 'Food Innovation and Health Programme, Quadram Institute Bioscience, Norwich, NR4 7UQ, UK.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Perez-Moral', 'Affiliation': 'Food Innovation and Health Programme, Quadram Institute Bioscience, Norwich, NR4 7UQ, UK.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Needs', 'Affiliation': 'Food Innovation and Health Programme, Quadram Institute Bioscience, Norwich, NR4 7UQ, UK.'}, {'ForeName': 'George M', 'Initials': 'GM', 'LastName': 'Savva', 'Affiliation': 'Core Research Services, Quadram Institute Bioscience, Norwich, NR4 7UQ, UK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Kroon', 'Affiliation': 'Food Innovation and Health Programme, Quadram Institute Bioscience, Norwich, NR4 7UQ, UK.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901135']
460,32227638,Different Mismatch Concepts for Magnetic Resonance Imaging-Guided Thrombolysis in Unknown Onset Stroke.,"OBJECTIVE


To explore the prevalence of the perfusion-weighted imaging (PWI)-diffusion-weighted imaging (DWI) mismatch and response to intravenous thrombolysis in the WAKE-UP trial.
METHODS


We performed a prespecified post hoc analysis of ischemic stroke patients screened for DWI-fluid-attenuated inversion recovery (FLAIR) mismatch in WAKE-UP who underwent PWI. We defined PWI-DWI mismatch as ischemic core volume < 70ml, mismatch volume > 10ml, and mismatch ratio > 1.2. Primary efficacy end point was a modified Rankin Scale score of 0-1 at 90 days, adjusted for age and symptom severity.
RESULTS


Of 1,362 magnetic resonance imaging-screened patients, 431 underwent PWI. Of these, 57 (13%) had a double mismatch, 151 (35%) only a DWI-FLAIR mismatch, and 54 (13%) only a PWI-DWI mismatch. DWI-FLAIR mismatch was more prevalent than PWI-DWI mismatch (48%, 95% confidence interval [CI] = 43-53% vs 26%, 95% CI = 22-30%; p < 0.0001). Screening for either one of the mismatch profiles resulted in a yield of 61% (95% CI = 56-65%). Prevalence of PWI-DWI mismatch was similar in patients with (27%) or without (24%) DWI-FLAIR mismatch (p = 0.52). In an exploratory analysis in the small subgroup of 208 randomized patients with PWI, PWI-DWI mismatch status did not modify the treatment response (p for interaction = 0.73).
INTERPRETATION


Evaluating both the DWI-FLAIR and PWI-DWI mismatch patterns in patients with unknown time of stroke onset will result in the highest yield of thrombolysis treatment. The treatment benefit of alteplase in patients with a DWI-FLAIR mismatch seems to be driven not merely by the presence of a PWI-DWI mismatch, although this analysis was underpowered. ANN NEUROL 2020;87:931-938.",2020,Prevalence of PWI-DWI mismatch was similar in patients with (27%) or without (24%) DWI-FLAIR mismatch (p = 0.52).,"['1,362 magnetic resonance imaging (MRI) screened patients, 431 underwent PWI', 'ischemic stroke patients screened for DWI - fluid-attenuated inversion recovery (FLAIR) mismatch in WAKE-UP who underwent PWI', 'patients with a DWI-FLAIR mismatch']",['perfusion-weighted imaging (PWI) - diffusion-weighted imaging'],"['modified Rankin Scale score of 0-1 at 90\u2009days, adjusted for age and symptom severity', 'Prevalence of PWI-DWI mismatch']","[{'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0021945', 'cui_str': 'Inversion (morphologic abnormality)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",208.0,0.139603,Prevalence of PWI-DWI mismatch was similar in patients with (27%) or without (24%) DWI-FLAIR mismatch (p = 0.52).,"[{'ForeName': 'Lauranne', 'Initials': 'L', 'LastName': 'Scheldeman', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Wouters', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Boutitie', 'Affiliation': 'Hospices Civils de Lyon, Service de Biostatistique, F-69003 Lyon, France; Université Lyon 1, F-69100, Villeurbanne, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dupont', 'Affiliation': 'Department of Neurosciences, Laboratory for Cognitive Neurology, KU Leuven-University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'GrayNumber Analytics, Lomma, Sweden.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurology, Head and Neurocenter, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ebinger', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jochen B', 'Initials': 'JB', 'LastName': 'Fiebach', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerloff', 'Affiliation': 'Department of Neurology, Head and Neurocenter, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Institute of Neuroscience & Psychology, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Nighoghossian', 'Affiliation': 'Department of Stroke Medicine, Claude Bernard University Lyon 1, CREATIS National Center for Scientific Research Mixed Unit of Research 5220-National Institute of Health and Medical Research U1206, National Institute of Applied Sciences of Lyon, Lyon Civil Hospices, Lyon, France.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Pedraza', 'Affiliation': 'Department of Radiology, Institute of Diagnostic Imaging, Dr Josep Trueta Hospital, Girona Institute of Biomedical Research, Marti and Julia de Salt Hospital Park - Building M2, Girona, Spain.'}, {'ForeName': 'Claus Z', 'Initials': 'CZ', 'LastName': 'Simonsen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'Stroke Theme, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Thomalla', 'Affiliation': 'Department of Neurology, Head and Neurocenter, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Lemmens', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25730']
461,32107938,The Legacy Effect in Treating Hypercholesterolemia.,"BACKGROUND


The duration of randomized controlled clinical trials usually is approximately 3 to 5 years although hypercholesterolemia and other risk factors for atherosclerotic cardiovascular disease (ASCVD) are lifelong conditions.
OBJECTIVES


The legacy effect, defined as the persistence of benefit of pharmacologic interventions in clinical trials after the end of the randomized phase when all participants receive active therapy, is used to examine the long-term benefit. We summarize the evidence for the existence of the legacy effect as it pertains to hypercholesterolemia, describe underlying mechanisms, and discuss its relevance to clinical practice.
METHODS


We examined all published (n = 13) randomized clinical trials of lipid-lowering agents compared to placebo or usual care with follow-up after the randomized phase for the presence or absence of a legacy effect.
RESULTS


A legacy effect was demonstrated in all studies. The current US and European guidelines recommend treatment with high-intensity statins for patients with manifest ASCVD and that individualized approach be used for primary prevention.
CONCLUSION


The legacy effect results in significant long-term clinical benefits by preventing fatal and nonfatal events. This implies that early therapy would result in lower event rates. Long-term follow-up should be a part of clinical trial design in order to evaluate the presence or absence of a legacy effect.",2020,"The legacy effect, defined as the persistence of benefit of pharmacologic interventions in clinical trials after the end of the randomized phase when all participants receive active therapy, is used to examine the long-term benefit.","['patients with manifest ASCVD', 'We examined all published (n = 13) randomized clinical trials of']",['lipid-lowering agents compared to placebo'],['fatal and nonfatal events'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205319', 'cui_str': 'Manifest (qualifier value)'}, {'cui': 'C3539085', 'cui_str': 'All'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0086440', 'cui_str': 'Antilipemic Agents'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",13.0,0.120009,"The legacy effect, defined as the persistence of benefit of pharmacologic interventions in clinical trials after the end of the randomized phase when all participants receive active therapy, is used to examine the long-term benefit.","[{'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Kostis', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Cardiovascular Institute, New Brunswick, NJ, USA.'}, {'ForeName': 'Mrinali', 'Initials': 'M', 'LastName': 'Shetty', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Cardiovascular Institute, New Brunswick, NJ, USA.'}, {'ForeName': 'Yuvraj Singh', 'Initials': 'YS', 'LastName': 'Chowdhury', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Cardiovascular Institute, New Brunswick, NJ, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kostis', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Cardiovascular Institute, New Brunswick, NJ, USA.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420907256']
462,32202920,"Acceptability, Feasibility, and Preliminary Efficacy of a Resilience-Oriented Family Intervention to Prevent Adolescent HIV and Depression: A Pilot Randomized Controlled Trial.","We tested the acceptability, feasibility, and preliminary efficacy of Our Family Our Future, a resilience-oriented intervention engaging families in prevention of adolescent HIV and depression. South African adolescents, 13-15 years of age, with mild depressive symptoms, were randomized to intervention or wait-list using parallel assignment in a single-blind trial. HIV risk behavior and depression were evaluated at baseline, 1, and 3 months. We examined intervention satisfaction, fidelity, trial retention, and preliminary efficacy. One hundred-ninety-six adolescent-parent dyads completed eligibility screening and baseline, and n = 73 dyads were randomized. All families ranked intervention quality as good or excellent. Over 90% were satisfied with content. Facilitators were adherent to intervention protocol. All families were retained in post-intervention assessments. Intervention recipients reported diminished depressive symptoms, inconsistent condom use, and sexual activity, as well as increased HIV testing. Our Family Our Future is highly acceptable and feasible and should be tested in a future efficacy trial.",2020,"We tested the acceptability, feasibility, and preliminary efficacy of Our Family Our Future, a resilience-oriented intervention engaging families in prevention of adolescent HIV and depression.","['South African adolescents, 13-15 years of age, with mild depressive symptoms', 'One hundred-ninety-six adolescent-parent dyads completed eligibility screening and baseline, and n = 73 dyads were randomized', 'Adolescent HIV and Depression']",['Resilience-Oriented Family Intervention'],"['depressive symptoms, inconsistent condom use, and sexual activity, as well as increased HIV testing', 'HIV risk behavior and depression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0442809', 'cui_str': 'Inconsistent (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",73.0,0.118718,"We tested the acceptability, feasibility, and preliminary efficacy of Our Family Our Future, a resilience-oriented intervention engaging families in prevention of adolescent HIV and depression.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kuo', 'Affiliation': 'Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mathews', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Giovenco', 'Affiliation': 'University of North Carolina at Chapel Hill, Gillings School of Global Public Health.'}, {'ForeName': 'Millicent', 'Initials': 'M', 'LastName': 'Atujuna', 'Affiliation': 'Desmond Tutu HIV Foundation, Cape Town, South Africa.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Beardslee', 'Affiliation': ""Judge Baker Children's Center, Harvard Medical School, and Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hoare', 'Affiliation': 'University of Cape Town.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'South African Medical Research Council Unit on Risk & Resilience in Mental Disorders, University of Cape Town.'}, {'ForeName': 'Larry K', 'Initials': 'LK', 'LastName': 'Brown', 'Affiliation': 'Alpert Medical School of Brown University, Providence, Rhode Island, and the Providence/Boston Center for AIDS Research.'}]",AIDS education and prevention : official publication of the International Society for AIDS Education,['10.1521/aeap.2020.32.1.67']
463,30314833,Distal Versus Traditional Radial Approach for Coronary Angiography.,"PURPOSE


The aim of this study was to evaluate the efficacy and safety of distal radial (DR) versus traditional radial (TR) approach during coronary angiography.
METHODS


Two hundred patients scheduled to undergo transradial coronary angiography were randomized between the two approaches. Primary endpoint of the study was switching to another access site due to inability of successful target artery cannulation. Secondary endpoints were time to cannulation, total procedure duration, number of attempts, number of skin punctures and duration of manual hemostasis. Secondary safety endpoints were the rate of moderate or severe spasm, arm hematoma EASY class III or more and radial artery occlusion at discharge. Quality of life endpoint was the patient's preference of cannulation method at 30 days.
RESULTS


The primary endpoint was met in 30 patients (30%) from the DR group and 2 patients (2%) from the TR group (p < 0.001). The time of cannulation was longer in the DR group compared to the TR group (269 ± 251 s vs 140 ± 161 s, p < 0.001), but this did not affect the total procedural duration (925 ± 896 s vs 831 ± 424 s, p = 0.494). The number of attempts and the number of skin punctures were more in the DR group compared to the TR group (6.8 ± 6.2 vs 3.4 ± 4.5, p < 0.001 and 2.4 ± 1.7 vs 1.6 ± 1.2, p < 0.001, respectively). However, DR treated patients had faster manual hemostasis time compared to TR treated patients (568 ± 462 s vs 841 ± 574 s, p = 0.002). There were no differences recorded in the safety endpoints of moderate or severe spasm, EASY grade III or more radial hematomas or the incidence of radial artery occlusion after the procedure. Patients' preference to the randomized puncture sites was the same (79% vs 85%, p = 0.358).
CONCLUSION


Distal radial approach is associated with lower successful cannulation rates and shorter manual hemostasis time compared to the traditional radial approach.",2019,"There were no differences recorded in the safety endpoints of moderate or severe spasm, EASY grade III or more radial hematomas or the incidence of radial artery occlusion after the procedure.",['Two hundred patients scheduled to undergo'],"['transradial coronary angiography', 'Distal versus traditional radial approach for coronary angiography', 'distal radial (DR) versus traditional radial (TR) approach']","['safety endpoints of moderate or severe spasm, EASY grade III or more radial hematomas or the incidence of radial artery occlusion', 'switching to another access site due to inability of successful target artery cannulation', 'rate of moderate or severe spasm, arm hematoma EASY class III or more and radial artery occlusion at discharge', 'successful cannulation rates', 'efficacy and safety', 'number of attempts and the number of skin punctures', 'time to cannulation, total procedure duration, number of attempts, number of skin punctures and duration of manual hemostasis', 'manual hemostasis time', 'total procedural duration', 'Quality of life endpoint', 'time of cannulation']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0037763', 'cui_str': 'Muscular Spasm'}, {'cui': 'C0332219', 'cui_str': 'Easy (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0441887', 'cui_str': 'Class 3 (qualifier value)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0034380'}]",200.0,0.149881,"There were no differences recorded in the safety endpoints of moderate or severe spasm, EASY grade III or more radial hematomas or the incidence of radial artery occlusion after the procedure.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koutouzis', 'Affiliation': 'Department of Cardiology, Red Cross General Hospital, Greece. Electronic address: koutouzismike@yahoo.gr.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Kontopodis', 'Affiliation': 'Department of Cardiology, Red Cross General Hospital, Greece.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Tassopoulos', 'Affiliation': 'Department of Cardiology, Red Cross General Hospital, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Tsiafoutis', 'Affiliation': 'Department of Cardiology, Red Cross General Hospital, Greece.'}, {'ForeName': 'Konstantina', 'Initials': 'K', 'LastName': 'Katsanou', 'Affiliation': 'Department of Cardiology, Red Cross General Hospital, Greece.'}, {'ForeName': 'Aggeliki', 'Initials': 'A', 'LastName': 'Rigatou', 'Affiliation': 'Department of Cardiology, Red Cross General Hospital, Greece.'}, {'ForeName': 'Matthaios', 'Initials': 'M', 'LastName': 'Didagelos', 'Affiliation': 'Department of Cardiology, Aristoteleion University of Thessaloniki, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Andreou', 'Affiliation': 'Department of Cardiology, Red Cross General Hospital, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Lazaris', 'Affiliation': 'Department of Cardiology, Red Cross General Hospital, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Oikonomidis', 'Affiliation': 'Department of Cardiology, Red Cross General Hospital, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Maniotis', 'Affiliation': 'Department of Cardiology, Red Cross General Hospital, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Ziakas', 'Affiliation': 'Department of Cardiology, Aristoteleion University of Thessaloniki, Greece.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2018.09.018']
464,32310162,Brain Perfusion Change in Patients with Mild Cognitive Impairment After 12 Months of Aerobic Exercise Training.,"Aerobic exercise (AE) has recently received increasing attention in the prevention of Alzheimer's disease (AD). There is some evidence that it can improve neurocognitive function in elderly individuals. However, the mechanism of these improvements is not completely understood. In this prospective clinical trial, thirty amnestic mild cognitive impairment participants were enrolled into two groups and underwent 12 months of intervention. One group (n = 15) performed AE training (8M/7F, age = 66.4 years), whereas the other (n = 15) performed stretch training (8M/7F, age = 66.1 years) as a control intervention. Both groups performed 25-30 minutes training, 3 times per week. Frequency and duration were gradually increased over time. Twelve-month AE training improved cardiorespiratory fitness (p = 0.04) and memory function (p = 0.004). Cerebral blood flow (CBF) was measured at pre- and post-training using pseudo-continuous-arterial-spin-labeling MRI. Relative to the stretch group, the AE group displayed a training-related increase in CBF in the anterior cingulate cortex (p = 0.016). Furthermore, across individuals, the extent of memory improvement was associated with CBF increases in anterior cingulate cortex and adjacent prefrontal cortex (voxel-wise p < 0.05). In contrast, AE resulted in a decrease in CBF of the posterior cingulate cortex, when compared to the stretch group (p = 0.01). These results suggest that salutary effects of AE in AD may be mediated by redistribution of blood flow and neural activity in AD-sensitive regions of brain.",2020,Twelve-month AE training improved cardiorespiratory fitness (p = 0.04) and memory function (p = 0.004).,"['Patients with Mild Cognitive Impairment', 'thirty amnestic mild cognitive impairment participants', 'elderly individuals']","['Aerobic Exercise Training', 'AE training', 'Aerobic exercise (AE', 'stretch training (8M/7F, age\u200a=\u200a66.1 years) as a control intervention']","['Cerebral blood flow (CBF', 'blood flow and neural activity', 'CBF', 'memory function', 'CBF increases in anterior cingulate cortex and adjacent prefrontal cortex', 'CBF of the posterior cingulate cortex', 'neurocognitive function', 'cardiorespiratory fitness', 'Frequency and duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",30.0,0.0166923,Twelve-month AE training improved cardiorespiratory fitness (p = 0.04) and memory function (p = 0.004).,"[{'ForeName': 'Binu P', 'Initials': 'BP', 'LastName': 'Thomas', 'Affiliation': 'Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tarumi', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital, Dallas, TX, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Sheng', 'Affiliation': 'Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Tseng', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital, Dallas, TX, USA.'}, {'ForeName': 'Kyle B', 'Initials': 'KB', 'LastName': 'Womack', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'C Munro', 'Initials': 'CM', 'LastName': 'Cullum', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Rypma', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital, Dallas, TX, USA.'}, {'ForeName': 'Hanzhang', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190977']
465,32310169,"A Placebo-Controlled, Parallel-Group, Randomized Clinical Trial of AC-1204 in Mild-to-Moderate Alzheimer's Disease.","BACKGROUND


Alzheimer's disease (AD) is characterized by amyloid-β plaques, neurofibrillary tangles, and regional cerebral glucose hypometabolism. Providing an alternative metabolic substrate, such as ketone bodies, may be a viable therapeutic option.
OBJECTIVE


The objective was to determine the efficacy and safety of the AC-1204 formulation of caprylic triglyceride administered daily for 26 weeks in APOE4 non-carrier participants with mild-to-moderate AD.
METHODS


In a double-blind, placebo-controlled, randomized study (AC-12-010, NOURISH AD, NCT01741194), 413 patients with mild-to-moderate probable AD were stratified by APOE genotype and randomized (1 : 1) to receive either placebo or AC-1204 for 26 weeks. The primary outcome was the change from baseline to week 26 on the 11-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog11) among APOE4 non-carriers. The key secondary outcome was the change from baseline to week 26 in the Alzheimer's Disease Cooperative Study - Clinician's Global Impression of Change scale.
RESULTS


Administration of AC-1204 was safe and well-tolerated. Mean changes from baseline in the primary outcome at 26 weeks in ADAS-Cog11 for placebo (n = 138) was 0.0 and for AC-1204 (n = 137) was 0.6 (LS differences of mean - 0.761, p = 0.2458) and secondary outcome measures failed to detect any drug effects.
CONCLUSION


The AC-1204 formulation of caprylic triglyceride failed to improve cognition or functional ability in subjects with mild-to-moderate AD. The lack of efficacy observed in this study may have several contributing factors including a lower ketone body formation from AC-1204 than expected and a lack of decline in the patients receiving placebo.",2020,The AC-1204 formulation of caprylic triglyceride failed to improve cognition or functional ability in subjects with mild-to-moderate AD.,"['413 patients with mild-to-moderate probable AD were stratified by APOE genotype and randomized ', ""Mild-to-Moderate Alzheimer's Disease"", 'subjects with mild-to-moderate AD', '26 weeks in APOE4 non-carrier participants with mild-to-moderate AD']","['placebo or AC-1204', 'placebo', 'AC-1204', 'caprylic triglyceride', 'Placebo']","['efficacy and safety', 'cognition or functional ability', ""11-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog11"", ""Alzheimer's Disease Cooperative Study - Clinician's Global Impression of Change scale"", 'safe and well-tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0003595', 'cui_str': 'Apolipoprotein E'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0052201', 'cui_str': 'Apolipoprotein E4'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0077030', 'cui_str': 'tricaprylin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",413.0,0.511938,The AC-1204 formulation of caprylic triglyceride failed to improve cognition or functional ability in subjects with mild-to-moderate AD.,"[{'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Henderson', 'Affiliation': 'Cerecin, Inc, Denver, CO, USA and Singapore.'}, {'ForeName': 'Bruce H', 'Initials': 'BH', 'LastName': 'Morimoto', 'Affiliation': 'Cerecin, Inc, Denver, CO, USA and Singapore.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Cummings', 'Affiliation': 'Department of Brain Health, School of Integrated Health Sciences, University of Nevada, Las Vegas (UNLV), Las Vegas, NV, USA.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Farlow', 'Affiliation': 'Department of Neurology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Cerecin, Inc, Denver, CO, USA and Singapore.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191302']
466,32310196,Upper limb recovery in early acute phase stroke survivors by coupled EMG-triggered and cyclic neuromuscular electrical stimulation.,"BACKGROUND


Few patients with severe upper extremity (UE) paresis after stroke achieved full recovery, because of the lack of a definitive approach to improve severe UE paresis immediately after onset.
OBJECTIVE


to investigate the effects of coupled EMG-triggered and cyclic neuromuscular electrical stimulation (NMES) on UE paresis during early acute phase of stroke.
METHODS


Seventeen participants with severe UE disability met the criteria. 8 subjects received 20 minutes of NMES prior to standard care per session, while 9 age- and severity-matched subjects received two times 20 minutes of standard care. Outcome measures included UE motor section of the Fugl-Meyer Motor Assessment Scale (FMA-UE), Wolf motor function test (WMFT), and box and block test (BBT).
RESULTS


The NMES group received treatment (average session: 10.87) after a median 7 days from stroke (16.5 sessions after 5 days for control). To adjust the different treatment durations, we defined ""progress rate"" as the gains of UE function scores divided by treatment duration. The progress rate was significantly different in FMA-UE, but not in WMFT and BBT.
CONCLUSIONS


The present study suggested beneficial effects of coupled NMES on UE paresis during early acute phase of stroke.",2020,"The progress rate was significantly different in FMA-UE, but not in WMFT and BBT.
","['Seventeen participants with severe UE disability met the criteria', 'UE paresis during early acute phase of stroke']","['NMES', 'coupled EMG-triggered and cyclic neuromuscular electrical stimulation (NMES', 'coupled NMES']","['UE motor section of the Fugl-Meyer Motor Assessment Scale (FMA-UE), Wolf motor function test (WMFT), and box and block test (BBT', 'progress rate']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0451321', 'cui_str': 'Motor assessment scale'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]",17.0,0.0424184,"The progress rate was significantly different in FMA-UE, but not in WMFT and BBT.
","[{'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Obayashi', 'Affiliation': 'Department of Rehabilitation Medicine, Dokkyo Medical University Saitama Medical Center, Koshigaya, Saitama, Japan.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Takahashi', 'Affiliation': 'Department of Rehabilitation Medicine, Dokkyo Medical University Saitama Medical Center, Koshigaya, Saitama, Japan.'}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Onuki', 'Affiliation': 'Department of Rehabilitation Medicine, Dokkyo Medical University Saitama Medical Center, Koshigaya, Saitama, Japan.'}]",NeuroRehabilitation,['10.3233/NRE-203024']
467,32310197,Effect of task-oriented circuit training on motor and cognitive performance in patients with multiple sclerosis: A single-blinded randomized controlled trial.,"BACKGROUND


Exercise training has positive effects on motor and cognitive performance which deteriorates over time in patients with Multiple Sclerosis (MS). The effects of task-oriented circuit training (TOCT) on motor and cognitive performance in patients with MS are not yet clear.
OBJECTIVE


The aims of this study are to investigate the effects of TOCT on balance, walking, manual dexterity, cognitive performance, and to determine the extent to which patients are able to transfer changes in their performance to activities of daily living.
METHODS


Twenty patients with MS (EDSS: 2-5.5), were randomly assigned to two groups; the task-oriented circuit training group (TOCTG, n:10) and the control group (CG, n:10). The TOCTG received TOCT twice a week for six weeks while the CG performed the relaxation exercises at home. All patients were assessed by using Modified Sensory Organization Test, Berg Balance Scale, Activities-specific Balance Confidence, Timed Up and Go, Functional Gait Assessment, 12-item Multiple Sclerosis Walking Scale, Nine-Hole Peg Test, Brief Repeatable Battery of Neuropsychological Tests, Multiple Sclerosis Neuropsychological Questionnaire.
RESULTS


Balance and walking performance were improved after TOCT (p < 0.05), whereas manual dexterity and cognitive performance except for verbal memory did not change significantly (p > 0.05). The CG showed no changes in any measurements (p > 0.05).
CONCLUSIONS


TOCT is quite effective to improve balance and walking in patients with MS. However, further studies are needed to determine the effect of TOCT on cognitive performance.",2020,"RESULTS


Balance and walking performance were improved after TOCT (p <  0.05), whereas manual dexterity and cognitive performance except for verbal memory did not change significantly (p >  0.05).","['Twenty patients with MS (EDSS: 2-5.5', 'patients with MS', 'patients with Multiple Sclerosis (MS', 'patients with multiple sclerosis']","['Exercise training', 'TOCT', 'task-oriented circuit training group (TOCTG, n:10) and the control group (CG, n:10', 'task-oriented circuit training (TOCT', 'task-oriented circuit training']","['Multiple Sclerosis Walking Scale, Nine-Hole Peg Test, Brief Repeatable Battery of Neuropsychological Tests, Multiple Sclerosis Neuropsychological Questionnaire', 'motor and cognitive performance', 'Modified Sensory Organization Test, Berg Balance Scale, Activities-specific Balance Confidence, Timed Up and Go, Functional Gait Assessment, 12-item', 'manual dexterity and cognitive performance except for verbal memory', 'balance, walking, manual dexterity, cognitive performance', 'Balance and walking performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C3844008', 'cui_str': '5.5'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4720873', 'cui_str': 'Sensory organization test'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}]",20.0,0.0146737,"RESULTS


Balance and walking performance were improved after TOCT (p <  0.05), whereas manual dexterity and cognitive performance except for verbal memory did not change significantly (p >  0.05).","[{'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Ozkul', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Guclu-Gunduz', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Kader', 'Initials': 'K', 'LastName': 'Eldemir', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Apaydin', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Cagri', 'Initials': 'C', 'LastName': 'Gulsen', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Yazici', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Soke', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Ceyla', 'Initials': 'C', 'LastName': 'Irkec', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Neurology, Ankara, Turkey.'}]",NeuroRehabilitation,['10.3233/NRE-203029']
468,32306153,High dietary sodium augments vascular tone and attenuates low-flow mediated constriction in salt-resistant adults.,"INTRODUCTION


Low-flow mediated constriction (L-FMC) has emerged as a valuable and complementary measure of flow-mediated dilation (FMD) for assessing endothelial function non-invasively. High dietary sodium has been shown to impair FMD independent of changes in blood pressure (BP), but its effects on L-FMC are unknown.
PURPOSE


To test the hypothesis that high dietary sodium would attenuate brachial artery L-FMC in salt-resistant adults.
METHODS


Fifteen healthy, normotensive adults (29 ± 6 years) participated in a controlled feeding study. Following a run-in diet, participants completed a 7-day low sodium (LS; 20 mmol sodium/day) and 7-day high sodium (HS; 300 mmol sodium/day) diet in randomized order. On the last day of each diet, 24 h urine was collected and assessments of 24 h ambulatory BP and L-FMC were performed. Salt-resistance was defined as a change in 24 h ambulatory mean arterial pressure (MAP) between the LS and HS diets of ≤ 5 mmHg. Resting vascular tone and L-FMC were calculated from ultrasound-derived arterial diameters.
RESULTS


High dietary sodium increased serum sodium and urinary sodium excretion (p < 0.001 for both), but 24 h MAP was unchanged (p = 0.16) by design. High dietary sodium augmented vascular tone (LS: 91 ± 23%, HS: 125 ± 56%, p = 0.01) and attenuated L-FMC (LS: - 0.58 ± 0.99%, HS: 0.17 ± 1.23%, p = 0.008).
CONCLUSION


These findings in salt-resistant adults provide additional evidence that dietary sodium has adverse vascular effects independent of changes in BP.",2020,"High dietary sodium augmented vascular tone (LS: 91 ± 23%, HS: 125 ± 56%, p = 0.01) and attenuated L-FMC (LS: - 0.58 ± 0.99%, HS: 0.17 ± 1.23%, p = 0.008).
","['Fifteen healthy, normotensive adults (29\u2009±\u20096\xa0years', 'salt-resistant adults']","['Low-flow mediated constriction (L-FMC', '7-day low sodium (LS; 20\xa0mmol sodium/day) and 7-day high sodium (HS; 300\xa0mmol sodium/day) diet', 'High dietary sodium']","['vascular tone', 'Salt-resistance', 'blood pressure (BP', 'Resting vascular tone and L-FMC', 'ambulatory mean arterial pressure (MAP', 'serum sodium and urinary sodium excretion', 'brachial artery L-FMC']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0595879', 'cui_str': 'Sodium high'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037570', 'cui_str': 'Dietary Sodium'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}]",15.0,0.0307452,"High dietary sodium augmented vascular tone (LS: 91 ± 23%, HS: 125 ± 56%, p = 0.01) and attenuated L-FMC (LS: - 0.58 ± 0.99%, HS: 0.17 ± 1.23%, p = 0.008).
","[{'ForeName': 'Ninette', 'Initials': 'N', 'LastName': 'Shenouda', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Meghan G', 'Initials': 'MG', 'LastName': 'Ramick', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Lennon', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA. dge@udel.edu.'}]",European journal of applied physiology,['10.1007/s00421-020-04370-0']
469,32306154,Acute hypertrophic but not maximal strength loading transiently enhances the kynurenine pathway towards kynurenic acid.,"PURPOSE


Due to distinct immuno- and neuro-modulatory properties, growing research interest focuses on exercise-induced alterations of the kynurenine (KYN) pathway in healthy and clinical populations. To date, knowledge about the impact of different acute strength exercise modalities on the KYN pathway is scarce. Therefore, we investigated the acute effects of hypertrophic (HYP) compared to maximal (MAX) strength loadings on the KYN pathway regulation.
METHODS


Blood samples of twelve healthy males (mean age and weight: 23.5 ± 3.2 years; 77.5 ± 7.5 kg) were collected before (T 0 ), immediately after (T 1 ), and 1 h after completion (T 2 ) of HYP (5 sets with 10 repetitions at 80% of 1RM) and MAX (15 sets with 1RM) loadings performed in a randomized cross-over design. Serum concentrations of tryptophan (TRP), KYN, kynurenic acid (KA), and quinolinic acid (QA) were assessed using high-performance liquid chromatography.
RESULTS


The KA/KYN ratio increased from T 0  to T 1  (p = 0.01) and decreased from T 1  to T 2  (p = 0.011) in HYP, while it was maintained within MAX. Compared to MAX, serum concentrations of KA were greater in HYP at T 1  (p = 0.014). Moreover, the QA/KA ratio was significantly lower in HYP than in MAX at T 1  (p = 0.002).
CONCLUSION


Acute HYP loading led to increases in the metabolic flux yielding KA, thereby possibly promoting immunosuppression and neuroprotection. Our findings emphasize the potential of acute HYP exercise as short-term modulator of KYN pathway downstream to KA in healthy males and need to be proven in other samples.",2020,"Compared to MAX, serum concentrations of KA were greater in HYP at T 1  (p = 0.014).","['healthy males', 'healthy and clinical populations', 'Blood samples of twelve healthy males (mean age and weight: 23.5\u2009±\u20093.2\xa0years; 77.5\u2009±\u20097.5\xa0kg']",[],"['KA/KYN ratio', 'serum concentrations of KA', 'QA/KA ratio', 'Serum concentrations of tryptophan (TRP), KYN, kynurenic acid (KA), and quinolinic acid (QA']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517859', 'cui_str': '7.5'}]",[],"[{'cui': 'C0022816', 'cui_str': 'Kynurenic acid'}, {'cui': 'C0022818', 'cui_str': 'Kynurenine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034425', 'cui_str': 'Quinolinic Acids'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}]",12.0,0.0225537,"Compared to MAX, serum concentrations of KA were greater in HYP at T 1  (p = 0.014).","[{'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Joisten', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Schumann', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Schenk', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walzik', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Freitag', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Knoop', 'Affiliation': 'Center for Preventive Doping Research/Institute of Biochemistry, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Thevis', 'Affiliation': 'Center for Preventive Doping Research/Institute of Biochemistry, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Department for Molecular and Cellular Sports Medicine, Institute for Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany. philipp.zimmer@tu-dortmund.de.'}]",European journal of applied physiology,['10.1007/s00421-020-04375-9']
470,32314298,Comparative Study of Traditional Ablative CO 2  Laser-Assisted Topical Antifungal with only Topical Antifungal for Treating Onychomycosis: A Multicenter Study.,"BACKGROUND


The predominance of onychomycosis has been increasing recently. New medications and treatment modalities are being researched for better saturation of the antifungal agents through the nail plate topically because of the low resilience of some patients for the oral antifungal agents. Treatment of onychomycosis, mainly moderate to severe, can be very challenging, expensive, and time consuming.
OBJECTIVE


The objective of this clinical trial is to compare the efficacy and safety of a manually operated ablative CO 2  laser combined with a topical antifungal agent in patients with onychomycosis.
STUDY DESIGN


We conducted an open-label controlled prospective study of 160 eligible patients randomized into control and treatment groups with a 1:1 allocation in the department of dermatology in five different hospitals in Shanghai. It was a 6-month study where both groups were treated with a topical antifungal agent, with the treatment group also receiving ablation by the traditional CO 2  laser once a month for the first 3 months.
RESULTS


The clinical efficacy and mycological cure rate were significantly higher (p < 0.001) for the treatment group. Three (3.75%) patients from the control group and 18 (25%) patients from the treatment group achieved complete nail clearance along with negative potassium hydroxide and negative culture (primary endpoint) results at 24 weeks. Mycological clearance with at least moderate nail clearance (secondary endpoint) for the treatment group was also significantly higher (p < 0.001) for the laser treatment group. The laser treatment was mildly painful but tolerable by the patients. No drug interactions for both groups were encountered.
CONCLUSIONS


The ablative CO 2  laser is a primitive yet effective modality to be considered for the delivery of topical antifungal agents for the management of mild-to-severe onychomycosis. The laser has good tolerance in patients and is a common equipment found in most dermatology units even those without the latest medical technology.",2020,The clinical efficacy and mycological cure rate were significantly higher (p < 0.001) for the treatment group.,"['Treating Onychomycosis', '160 eligible patients randomized into control and treatment groups with a 1:1 allocation in the department of dermatology in five different hospitals in Shanghai', 'patients with onychomycosis']",['Traditional Ablative CO 2  Laser-Assisted Topical Antifungal with only Topical Antifungal'],"['Mycological clearance', 'clinical efficacy and mycological cure rate', 'efficacy and safety', 'nail clearance', 'complete nail clearance']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}]","[{'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",160.0,0.017543,The clinical efficacy and mycological cure rate were significantly higher (p < 0.001) for the treatment group.,"[{'ForeName': 'Bhavana', 'Initials': 'B', 'LastName': 'Rajbanshi', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Liangliang', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Jiaoyang', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Dermatology and Venereology, Putuo District Central Hospital, Shanghai, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Dermatology and Venereology, Jiading District Anting Hospital, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Dermatology and Venereology, Jiading District Nanxiang Hospital, Shanghai, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': 'Department of Dermatology and Venereology, Jiading District Central Hospital, Shanghai, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China.'}, {'ForeName': 'Jingjun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Dermatology and Venereology, Shanghai Tongji Hospital, Tongji University School of Medicine, 398 Xincun road, Putou District, Shanghai, China. zhaojingjun2015@aliyun.com.'}]",Clinical drug investigation,['10.1007/s40261-020-00914-6']
471,32309876,"The Feasibility, Safety, and Efficacy of the Preemptive Indwelling of Double-J Stents in Percutaneous Nephrolithotomy Surgery: A Randomized Controlled Trial.","PURPOSE


The goal of this study is to compare the feasibility, safety, and efficacy of the preemptive indwelling of double-J stents (PI-DJS) versus the conventional preemptive indwelling of ureteral catheters (PI-UC) in percutaneous nephrolithotomy (PCNL) via a randomized, controlled clinical study.
MATERIALS AND METHODS


A total of 75 patients with complex renal calculi underwent PCNL surgery and were randomized, using random number table, to receive either a PI-DJS (37 cases) or a PI-UC (38 cases). All operations were performed by the same experienced surgeon. Several outcomes were measured, including duration of operation, time to establish passage, level of hemoglobin decline, rate of stone clearance and incidence of complications.
RESULTS


Guided by B-ultrasound, percutaneous passages were successfully established in all patients who then underwent one-stage PCNL. The time required to establish a passage using a PI-DJS was 7.5min, whereas that of the group who received a PI-UC was 11.5min (P < 0.01). There was no significant difference between the two groups in terms of operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences (all P > 0.05).
CONCLUSION


PI-DJS during PCNL allowed for a reliable and stable reflux from the bladder into the renal pelvis to produce an artificial hydronephrosis without the formation of microbubbles, unlike conventional ureteral catheters.",2020,"There was no significant difference between the two groups in terms of operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences (p> 0.05).
","['Percutaneous Nephrolithotomy Surgery', '75 patients with complex renal calculi underwent PCNL surgery']","['Preemptive Indwelling of Double-J Stents', 'conventional preemptive indwelling of ureteral catheters (PI-UC', 'PI-DJS', 'preemptive indwelling of double-J stents (PI-DJS', 'percutaneous nephrolithotomy (PCNL']","['feasibility, safety, and efficacy', 'duration of operation, time to establish passage, level of hemoglobin decline, rate of stone clearance and incidence of complications', 'Feasibility, Safety, and Efficacy', 'operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences']","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0179799', 'cui_str': 'Ureteral catheter'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}]",75.0,0.0259171,"There was no significant difference between the two groups in terms of operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences (p> 0.05).
","[{'ForeName': 'Fuding', 'Initials': 'F', 'LastName': 'Bai', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China. bfd0816@hotmail.com.'}, {'ForeName': 'Huifeng', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'JiMin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jiaming', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}]",Urology journal,['10.22037/uj.v0i0.4957']
472,32305492,Probiotics and fructo-oligosaccharide intervention modulate the microbiota-gut brain axis to improve autism spectrum reducing also the hyper-serotonergic state and the dopamine metabolism disorder.,"The prevalence of autism spectrum disorders (ASD) is increasing, but its etiology remains elusive and hence an effective treatment is not available. Previous research conducted on animal models suggests that microbiota-gut-brain axis may contribute to ASD pathology and more human research is needed. This study was divided into two stages,.At the discovery stage, we compared the differences in gut microbiota profiles (using 16S rRNA sequencing), fecal SCFAs (using GC-MS) and plasma neurotransmitters (using UHPLC-MS/MS) of 26 children with ASD and 24 normal children. All 26 children with ASD participated in the intervention stage, and we measured the gut microbiota profiles, SCFAs and neurotransmitters before and after probiotics + FOS (n = 16) or placebo supplementation (n = 10). We found that gut microbiota was in a state of dysbiosis and significantly lower levels of Bifidobacteriales and Bifidobacterium longum were observed at the discovery stage in children with ASD. An increase in beneficial bacteria (Bifidobacteriales and B. longum) and suppression of suspected pathogenic bacteria (Clostridium) emerged after probiotics + FOS intervention, with significant reduction in the severity of autism and gastrointestinal symptoms. Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD. Interestingly, the above SCFAs in children with autism significantly elevated after probiotics + FOS intervention and approached those in the control group. In addition, our data demonstrated that decreased serotonin and increased homovanillic acid emerged after probiotics + FOS intervention. However, the above-mentioned changes did not appear in the placebo group for ASD children. Probiotics + FOS intervention can modulate gut microbiota, SCFAs and serotonin in association with improved ASD symptoms, including a hyper-serotonergic state and dopamine metabolism disorder.",2020,"Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD.","['26 children with ASD', '26 children with ASD and 24 normal children', 'autism', 'autism spectrum disorders (ASD', 'children with ASD']","['Probiotics and fructo-oligosaccharide intervention', 'placebo supplementation', 'Probiotics\u2009+\u2009FOS intervention', 'placebo']","['gut microbiota profiles (using 16S rRNA sequencing), fecal SCFAs (using GC-MS) and plasma neurotransmitters', 'hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid', 'severity of autism and gastrointestinal symptoms', 'acetic acid, propionic acid and butyric acid', 'homovanillic acid', 'beneficial bacteria (Bifidobacteriales and B. longum) and suppression of suspected pathogenic bacteria (Clostridium']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0087140', 'cui_str': 'v-fos Oncogenes'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0024868', 'cui_str': 'Chromatography, Gas-Mass Spectrometry'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019903', 'cui_str': 'Homovanillic acid'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0033482', 'cui_str': 'Propanoic Acids'}, {'cui': 'C0006523', 'cui_str': 'Butanoic Acids'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C1037103', 'cui_str': 'Bifidobacteriales'}, {'cui': 'C1564227', 'cui_str': 'Longum'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}]",26.0,0.0229384,"Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China; State Key Laboratory of Microbial Technology, Shandong University, Qingdao, Shandong, China. Electronic address: wangyingying67@163.com.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': ""Institute of Child Health Care, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 754520623@qq.com.""}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': 'College of Life Science, Qilu Normal University, Jinan, Shandong, China. Electronic address: microbiota@foxmail.com.'}, {'ForeName': 'Dong-Mei', 'Initials': 'DM', 'LastName': 'Zhao', 'Affiliation': ""Institute of Child Health Care, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: jnzhaodongmei@163.com.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine and Engineering, Beihang University, Key Laboratory of Big Data-Based Precision Medicine (Beihang University), the Ministry of Industry and Information Technology of the People's Republic of China, Beijing, China. Electronic address: binchen23@163.com.""}, {'ForeName': 'Guo-Qing', 'Initials': 'GQ', 'LastName': 'Zhang', 'Affiliation': 'Bio-Med Big Data Center, CAS Key Laboratory of Computational Biology, CAS-MPG Partner Institute for Computational Biology, Shanghai Institute of Nutrition and Health, Shanghai, China. Electronic address: gqzhang@picb.ac.cn.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Shenzhen Institute of Synthetic Biology, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, Guangdong, China; CAS Key Laboratory of Quantitative Engineering Biology, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, Guangdong, China. Electronic address: shuo.chen1@siat.ac.cn.'}, {'ForeName': 'Rui-Fang', 'Initials': 'RF', 'LastName': 'Cao', 'Affiliation': 'Bio-Med Big Data Center, CAS Key Laboratory of Computational Biology, CAS-MPG Partner Institute for Computational Biology, Shanghai Institute of Nutrition and Health, Shanghai, China. Electronic address: caoruifang@picb.ac.cn.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: yuhan_1991@163.com.""}, {'ForeName': 'Chang-Ying', 'Initials': 'CY', 'LastName': 'Zhao', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1163310981@qq.com.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1295163749@qq.com.""}, {'ForeName': 'Yong-Sheng', 'Initials': 'YS', 'LastName': 'Ge', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1305358934@qq.com.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: liuyi-ly@126.com.""}, {'ForeName': 'Le-Hai', 'Initials': 'LH', 'LastName': 'Zhang', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: zlh6813@126.com.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Microbial Technology, Shandong University, Qingdao, Shandong, China. Electronic address: hw_1@sdu.edu.cn.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine and Engineering, Beihang University, Key Laboratory of Big Data-Based Precision Medicine (Beihang University), the Ministry of Industry and Information Technology of the People's Republic of China, Beijing, China; Microbiome Research Center, Shandong Institutes for Food and Drug Control, Shandong Institute of Industrial Technology for Health Sciences and Precision Medicine, Jinan, Shandong, China. Electronic address: microbiome@foxmail.com.""}, {'ForeName': 'Zhong-Tao', 'Initials': 'ZT', 'LastName': 'Gai', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: gzt@etyy.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.104784']
473,31981648,Second-generation magnetically controlled capsule gastroscopy with improved image resolution and frame rate: a randomized controlled clinical trial (with video).,"BACKGROUND AND AIMS


Compared with conventional endoscopy, magnetically controlled capsule gastroscopy (MCCG) can be further optimized in gastric examination time and complete visualization of upper GI (UGI) mucosa. The second-generation MCCG (MCCG-2) was developed with higher image resolution and adaptive frame rate, and we aimed to evaluate its clinical availability for UGI examination in this study.
METHODS


Consecutive patients undergoing MCCG examination between May to June 2019 were prospectively enrolled and randomized to swallow the first-generation MCCG (MCCG-1) or MCCG-2 in a 1:1 ratio. The main outcomes included visualization of the esophagus and duodenum, operation-related parameters, image quality, maneuverability, detection of lesions, and safety evaluation.
RESULTS


Eighty patients were enrolled. In the MCCG-2 group, frames captured for esophageal mucosa and Z-line were 171.00 and 2.00, significantly increased from those in the MCCG-1 group (97.00 [P = .002] and .00 [P = .028], respectively). The gastric examination time was shortened from 7.78 ± .97 minutes to 5.27 ± .74 minutes (P < .001), with the total running time of the capsule extended from 702.83 minutes to 1001.99 minutes (P < .001). MCCG-2 also greatly improved the image quality (P < .001) and maneuverability (P < .01). No statistical difference existed in the detection of lesions between the 2 groups, and no adverse events occurred.
CONCLUSIONS


MCCG-2 showed better performance in mucosal visualization, examination duration, and maneuverability, making better diagnosis of UGI diseases a possibility. (Clinical trial registration number: NCT03977935.).",2020,MCCG-2 also greatly improved the image quality (P<0.001) and maneuverability (P<0.01).,"['Eighty patients were enrolled', 'Consecutive patients undergoing MCCG examination between May to June 2019']","['swallow the first-generation MCCG (MCCG-1) or MCCG-2', 'conventional endoscopy, magnetically controlled capsule gastroscopy (MCCG', 'Second-generation magnetically controlled capsule gastroscopy']","['image resolution and frame rate', 'visualization of the esophagus and duodenum, operation related parameters, image quality, maneuverability, detection of lesions, as well as safety evaluation', 'gastric examination time', 'image quality', 'detection of lesions', 'performance in mucosal visualization, examination duration and maneuverability', 'esophageal mucosa and Z-line', 'total running time of capsule']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0017195', 'cui_str': 'Gastroscopy'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0014876', 'cui_str': 'Esophagus'}, {'cui': 'C0013303', 'cui_str': 'Duodenum'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0227176', 'cui_str': 'Esophagus Mucosa'}, {'cui': 'C0230719', 'cui_str': 'Z line (cell structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]",80.0,0.129374,MCCG-2 also greatly improved the image quality (P<0.001) and maneuverability (P<0.01).,"[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yang-Yang', 'Initials': 'YY', 'LastName': 'Qian', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yuan-Chen', 'Initials': 'YC', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Jia-Hui', 'Initials': 'JH', 'LastName': 'Zhu', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Wen-Bin', 'Initials': 'WB', 'LastName': 'Zou', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Zhao-Shen', 'Initials': 'ZS', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.01.027']
474,32234584,Stigma interdependence among pregnant HIV-infected couples in a cluster randomized controlled trial from rural South Africa.,"BACKGROUND


Stigma can exacerbate negative health outcomes in people living with HIV (PLWH). This longitudinal, cluster randomized controlled trial in rural Mpumalanga, South Africa, examined the interdependence of HIV-related stigma among pregnant couples living with HIV, and the potential impact of a lay health worker delivered intervention, Protect Your Family, on changes in stigma over time across couples, controlling for physical intimate partner violence (IPV), verbal IPV, gender, HIV knowledge, and months since HIV diagnosis. Using a form of the Actor-Partner Interdependence model, changes in stigma over time were also examined within each dyad of seroconcordant participants with HIV.
METHOD


Antenatal clinics were randomized to experimental or control conditions, and participants completed baseline antenatal and 12-month postpartum assessments. Both women and male partners participated in intervention sessions in gender concordant groups and couple or individual sessions.
RESULTS


Multilevel models (N = 1475) revealed stigma was related to condition and verbal intimate partner violence, but not time. Using an Actor-Partner Interdependence cross-lagged path model to examine within dyad changes in stigma for seroconcordant couples (n = 201), intervention condition participants' stigma levels were not interdependent over time. Women's 12-month stigma was related to their partners' stigma at baseline in the control condition, but not in the intervention condition.
DISCUSSION


Compared to women in the control condition, postpartum stigma among women in the intervention condition was not related to their male partners' stigma, suggesting that women's perception of stigma became uncoupled from that of their partners. The intervention may have promoted female empowerment to shape their own beliefs and attitudes towards what it means to be infected with HIV, and express their own agency in responding to how others treat them and they treat themselves.",2020,"Compared to women in the control condition, postpartum stigma among women in the intervention condition was not related to their male partners' stigma, suggesting that women's perception of stigma became uncoupled from that of their partners.","['rural Mpumalanga, South Africa', 'Both women and male partners', 'people living with HIV (PLWH', 'Antenatal clinics', 'pregnant couples living with HIV', 'pregnant HIV-infected couples in a cluster randomized controlled trial from rural South Africa']",[],"['stigma was related to condition and verbal intimate partner violence', 'Stigma interdependence', 'postpartum stigma']","[{'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",,0.0392253,"Compared to women in the control condition, postpartum stigma among women in the intervention condition was not related to their male partners' stigma, suggesting that women's perception of stigma became uncoupled from that of their partners.","[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Abbamonte', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ramlagan', 'Affiliation': 'HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Cristofari', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Peltzer', 'Affiliation': 'HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa; Department of Research & Innovation, University of Limpopo, Sovenga, South Africa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sifunda', 'Affiliation': 'HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. Electronic address: djones@med.miami.edu.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.112940']
475,31400759,"RESTORE-IMI 1: A Multicenter, Randomized, Double-blind Trial Comparing Efficacy and Safety of Imipenem/Relebactam vs Colistin Plus Imipenem in Patients With Imipenem-nonsusceptible Bacterial Infections.","BACKGROUND


The β-lactamase inhibitor relebactam can restore imipenem activity against imipenem-nonsusceptible gram-negative pathogens. We evaluated imipenem/relebactam for treating imipenem-nonsusceptible infections.
METHODS


Randomized, controlled, double-blind, phase 3 trial. Hospitalized patients with hospital-acquired/ventilator-associated pneumonia, complicated intraabdominal infection, or complicated urinary tract infection caused by imipenem-nonsusceptible (but colistin- and imipenem/relebactam-susceptible) pathogens were randomized 2:1 to 5-21 days imipenem/relebactam or colistin+imipenem. Primary endpoint: favorable overall response (defined by relevant endpoints for each infection type) in the modified microbiologic intent-to-treat (mMITT) population (qualifying baseline pathogen and ≥1 dose study treatment). Secondary endpoints: clinical response, all-cause mortality, and treatment-emergent nephrotoxicity. Safety analyses included patients with ≥1 dose study treatment.
RESULTS


Thirty-one patients received imipenem/relebactam and 16 colistin+imipenem. Among mITT patients (n = 21 imipenem/relebactam, n = 10 colistin+imipenem), 29% had Acute Physiology and Chronic Health Evaluation II scores >15, 23% had creatinine clearance <60 mL/min, and 35% were aged ≥65 years. Qualifying baseline pathogens: Pseudomonas aeruginosa (77%), Klebsiella spp. (16%), other Enterobacteriaceae (6%). Favorable overall response was observed in 71% imipenem/relebactam and 70% colistin+imipenem patients (90% confidence interval [CI] for difference, -27.5, 21.4), day 28 favorable clinical response in 71% and 40% (90% CI, 1.3, 51.5), and 28-day mortality in 10% and 30% (90% CI, -46.4, 6.7), respectively. Serious adverse events (AEs) occurred in 10% of imipenem/relebactam and 31% of colistin+imipenem patients, drug-related AEs in 16% and 31% (no drug-related deaths), and treatment-emergent nephrotoxicity in 10% and 56% (P = .002), respectively.
CONCLUSIONS


Imipenem/relebactam is an efficacious and well-tolerated treatment option for carbapenem-nonsusceptible infections.
CLINICAL TRIALS REGISTRATION


NCT02452047.",2020,"Serious adverse events (AEs) occurred in 10% of imipenem/relebactam and 31% of colistin+imipenem patients, drug-related AEs in 16% and 31% (no drug-related deaths), and treatment-emergent nephrotoxicity in 10% and 56% (P = .002), respectively.
","['Qualifying baseline pathogens', 'Patients With Imipenem-nonsusceptible Bacterial Infections', 'patients with ≥1 dose study treatment', 'Hospitalized patients with hospital-acquired/ventilator-associated pneumonia, complicated intraabdominal infection, or complicated urinary tract infection caused by imipenem-nonsusceptible (but colistin- and imipenem/relebactam-susceptible) pathogens']","['Imipenem/relebactam', 'imipenem/relebactam or colistin+imipenem', 'imipenem/relebactam', 'Imipenem/Relebactam vs Colistin Plus Imipenem']","['clinical response, all-cause mortality, and treatment-emergent nephrotoxicity', 'Serious adverse events (AEs', 'creatinine clearance', 'clinical response', 'Favorable overall response', 'treatment-emergent nephrotoxicity', 'overall response (defined by relevant endpoints for each infection type) in the modified microbiologic intent-to-treat (mMITT) population', 'Acute Physiology and Chronic Health Evaluation II scores', '28-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0004623', 'cui_str': 'Bacterial Infections'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456393', 'cui_str': 'Hospital acquired (qualifier value)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C1112209', 'cui_str': 'Intra-Abdominal Infections'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C4317244'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}]","[{'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C4317244'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0599918', 'cui_str': 'Nephrotoxicity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0243028', 'cui_str': 'APACHE II'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",28.0,0.353527,"Serious adverse events (AEs) occurred in 10% of imipenem/relebactam and 31% of colistin+imipenem patients, drug-related AEs in 16% and 31% (no drug-related deaths), and treatment-emergent nephrotoxicity in 10% and 56% (P = .002), respectively.
","[{'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Motsch', 'Affiliation': 'Universitätsklinikum Heidelberg, Germany.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Murta de Oliveira', 'Affiliation': 'Santa Casa de Misericórdia, Belo Horizonte, Brazil.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Stus', 'Affiliation': 'Dnipropetrovsk Medical Academy, Dnipro, Ukraine.'}, {'ForeName': 'Iftihar', 'Initials': 'I', 'LastName': 'Köksal', 'Affiliation': 'Karadeniz Technical University School of Medicine, Trabzon, Turkey.'}, {'ForeName': 'Olexiy', 'Initials': 'O', 'LastName': 'Lyulko', 'Affiliation': 'Department of Urology, Zaporozhye State Medical University, Zaporozhye, Ukraine.'}, {'ForeName': 'Helen W', 'Initials': 'HW', 'LastName': 'Boucher', 'Affiliation': 'Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Kaye', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'File', 'Affiliation': 'Summa Health, Akron, Ohio.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Brown', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Ireen', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Jiejun', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Hee-Koung', 'Initials': 'HK', 'LastName': 'Joeng', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Tipping', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Aggrey', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Young', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Kartsonis', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Joan R', 'Initials': 'JR', 'LastName': 'Butterton', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Paschke', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz530']
476,32298870,The effects of transcranial direct current stimulation on within- and cross-paradigm transfer following multi-session backward recall training.,"Transcranial direct current stimulation (tDCS) has been shown to enhance the efficacy and generalisation of working memory (WM) training, but there has been little systematic investigation into how coupling task-specific WM training with stimulation impacts more specifically on transfer to untrained tasks. This randomised controlled trial investigated the boundary conditions to transfer by testing firstly whether the benefits of training on backward digit recall (BDR) extend to untrained backward recall tasks and n-back tasks with different materials, and secondly which, if any, form of transfer is enhanced by tDCS. Forty-eight participants were allocated to one of three conditions: BDR training with anodal (10 min, 1 mA) or sham tDCS, or visual search training with sham tDCS, applied over the left dorsolateral prefrontal cortex. Transfer was assessed on within- (backward recall with digits, letters, and spatial locations) and cross-paradigm (n-back with digits and letters) transfer tests following three sessions of training and stimulation. On-task training gains were found, with transfer to other backward span but not n-back tasks. There was little evidence that tDCS enhanced on-task training or transfer. These findings indicate that training enhances paradigm-specific processes within WM, but that tDCS does not enhance these gains.",2020,"Transcranial direct current stimulation (tDCS) has been shown to enhance the efficacy and generalisation of working memory (WM) training, but there has been little systematic investigation into how coupling task-specific WM training with stimulation impacts more specifically on transfer to untrained tasks.",['Forty-eight participants'],"['transcranial direct current stimulation', 'Transcranial direct current stimulation (tDCS', 'BDR training with anodal (10\u202fmin, 1\u202fmA) or sham tDCS, or visual search training with sham tDCS']","['backward digit recall (BDR', 'tDCS enhanced on-task training or transfer']","[{'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",48.0,0.0236361,"Transcranial direct current stimulation (tDCS) has been shown to enhance the efficacy and generalisation of working memory (WM) training, but there has been little systematic investigation into how coupling task-specific WM training with stimulation impacts more specifically on transfer to untrained tasks.","[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Byrne', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, 15 Chaucer Road, University of Cambridge, Cambridge CB2 7EF, UK. Electronic address: emb72@cam.ac.uk.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Ewbank', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, 15 Chaucer Road, University of Cambridge, Cambridge CB2 7EF, UK. Electronic address: m.ewbank@iesohealth.com.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Gathercole', 'Affiliation': 'Department of Psychiatry, Douglas House, 18b Trumpington Road, University of Cambridge, Cambridge CB2 8AH, UK. Electronic address: seg57@cam.ac.uk.'}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Holmes', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, 15 Chaucer Road, University of Cambridge, Cambridge CB2 7EF, UK. Electronic address: joni.holmes@mrc-cbu.cam.ac.uk.'}]",Brain and cognition,['10.1016/j.bandc.2020.105552']
477,32305259,Management of early pregnancy loss with mifepristone and misoprostol: clinical predictors of treatment success from a randomized trial.,"BACKGROUND


Early pregnancy loss is a common event in the first trimester, occurring in 15%-20% of confirmed pregnancies. A common evidence-based medical regimen for early pregnancy loss uses misoprostol, a prostaglandin E1 analog, with a dosage of 800 μg, self-administered vaginally. The clinical utility of this regimen is limited by suboptimal effectiveness in patients with a closed cervical os, with 29% of patients experiencing early pregnancy loss requiring a second dose after 3 days and 16% of patients eventually requiring a uterine aspiration procedure.
OBJECTIVE


This study aimed to evaluate clinical predictors associated with treatment success in patients receiving medical management with mifepristone-misoprostol or misoprostol alone for early pregnancy loss.
STUDY DESIGN


We performed a planned secondary analysis of a randomized trial comparing mifepristone-misoprostol with misoprostol alone for management of early pregnancy loss. The published prediction model for treatment success of single-dose misoprostol administered vaginally included the following variables: active bleeding, type of early pregnancy loss (anembryonic pregnancy or embryonic and/or fetal demise), parity, gestational age, and treatment site; previous significant predictors were vaginal bleeding within the past 24 hours and parity of 0 or 1 vs >1. To determine if these characteristics predicted differential proportions of patients with treatment success or failure, we performed bivariate analyses; given the small proportion of treatment failures in the combined treatment arm, both arms were combined for analysis. Thereafter, we performed a logistic regression analysis to assess the effect of these predictors collectively in each of the 2 treatment groups separately as well as in the full cohort as a proxy for the combined treatment arm. Finally, by using receiver operating characteristic curves, we tested the ability of these predictors in association with misoprostol treatment success to discriminate between treatment success and treatment failure. To quantify the ability of the score to discriminate between treatment success and treatment failure in each treatment arm as well as in the entire cohort, we calculated the area under the curve. Using multivariable logistic regression, we then assessed our study population for other predictors of treatment success in both treatment groups, with and without mifepristone pretreatment.
RESULTS


Overall, 297 evaluable participants were included in the primary study, with 148 in the mifepristone-misoprostol combined treatment group and 149 in the misoprostol-alone treatment group. Among patients who had vaginal bleeding at the time of treatment, 15 of 17 (88%) in the mifepristone-misoprostol combined treatment group and 12 of 17 (71%) in the misoprostol-alone treatment group experienced expulsion of pregnancy tissue. Among patients with a parity of 0 or 1, 94 of 108 (87%) in the mifepristone-misoprostol treatment group and 66 of 95 (69%) in the misoprostol-alone treatment group experienced expulsion of pregnancy tissue. These clinical characteristics did not predict treatment success in the combined cohort alone (area under the curve=0.56; 95% confidence interval, 0.48-0.64). No other baseline clinical factors predicted treatment success in the misoprostol-alone treatment arm or mifepristone pretreatment arm. In the full cohort, the significant predictors of treatment success were pretreatment with mifepristone (adjusted odds ratio=2.51; 95% confidence interval, 1.43-4.43) and smoking (adjusted odds ratio=2.15; 95% confidence interval, 1.03-4.49).
CONCLUSION


No baseline clinical factors predicted treatment success in women receiving medical management with misoprostol for early pregnancy loss. Adding mifepristone to the medical management regimen of early pregnancy loss improved treatment success; thus, mifepristone treatment should be considered for management of early pregnancy loss regardless of baseline clinical factors.",2020,No other baseline clinical factors predicted treatment success in the misoprostol-alone or mifepristone pretreatment arms individually.,"['alone for early pregnancy loss (EPL', 'women with a closed cervical os, with 29% of women with EPL requiring a second dose after three days, and 16% eventually requiring a uterine aspiration procedure', 'women with a parity of 0 or 1, 94/108 (87%) in the', 'women undergoing medical management of EPL with', 'women receiving medical management with', '297 evaluable subjects in the primary study, including 148 in the', 'combined and 149 in the misoprostol-alone groups', 'women who had vaginal bleeding at the time of treatment, 15/17 (88%) in the']","['prostaglandin E1 analogue misoprostol', 'misoprostol-alone', 'misoprostol-alone or mifepristone', 'mifepristone and misoprostol', 'mifepristone', 'mifepristone-misoprostol or misoprostol', 'mifepristone-misoprostol', 'misoprostol']","['vaginal bleeding', 'pregnancy']","[{'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C1185785', 'cui_str': 'External os structure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002335', 'cui_str': 'Alprostadil'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}]","[{'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",,0.312621,No other baseline clinical factors predicted treatment success in the misoprostol-alone or mifepristone pretreatment arms individually.,"[{'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Sonalkar', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Hospital of the University of Pennsylvania, Philadelphia, PA. Electronic address: sarita.sonalkar@pennmedicine.upenn.edu.'}, {'ForeName': 'Nathanael', 'Initials': 'N', 'LastName': 'Koelper', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Research on Reproduction and Women's Health, Philadelphia, PA.""}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Atrio', 'Affiliation': 'Department of Obstetrics and Gynecology, Montefiore Hospital and Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Department of Biostatistics and Informatics, Center for Integrative Design and Analysis, Colorado School of Public Health, Denver, CO.'}, {'ForeName': 'Arden', 'Initials': 'A', 'LastName': 'McAllister', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Hospital of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Hospital of the University of Pennsylvania, Philadelphia, PA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.04.006']
478,31802124,Adolescent/Young Adult Perspectives of a Therapeutic Music Video Intervention to Improve Resilience During Hematopoietic Stem Cell Transplant for Cancer.,"This empirical phenomenology study reports adolescents/young adults (AYA) experiences of the therapeutic music video (TMV) intervention arm of a randomized controlled clinical trial (Children's Oncology Group; COG-ANUR0631; R01 NR008583) during hospitalization for a hematopoietic stem cell transplant. A purposive subsample of 14 AYA were interviewed using a broad open-ended data-generating question about their TMV intervention experiences. At the end of each interview, we also asked AYA for suggestions on how to improve the TMV. Analysis of the narrative data resulted in four theme categories: (a) An Interwoven Experience of the Transplant and TMV Intervention; (b) TMV as a Guided Opportunity for Reflection, Self-Expression, and Meaning-Making; (c) Telling My Story: The Work of Deriving Meaning; and (d) A Way to Overcome the Bad Side of Cancer. AYA suggestions for improving the TMV are also summarized. Findings provide insight into ways the TMV supports AYA efforts to overcome distress and challenges by providing opportunities to reflect on what is meaningful, connect with others, and explore/identify personal strengths. Findings also inform our understanding about how the TMV may have functioned (i.e., mechanisms of action) to bring about significant change in AYA self-reported outcomes (i.e., positive coping, social support, and family function) for this trial.",2020,This empirical phenomenology study reports adolescents/young adults (AYA) experiences of the therapeutic music video (TMV) intervention arm of a randomized controlled clinical trial (Children's Oncology Group; COG-ANUR0631; R01 NR008583) during hospitalization for a hematopoietic stem cell transplant.,"['During Hematopoietic Stem Cell Transplant for Cancer', 'A purposive subsample of 14 AYA were interviewed using a broad open-ended data-generating question about their TMV intervention experiences']","['therapeutic music video (TMV) intervention', 'Therapeutic Music Video Intervention', 'Transplant and TMV Intervention']",[],"[{'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]",[],,0.0478659,This empirical phenomenology study reports adolescents/young adults (AYA) experiences of the therapeutic music video (TMV) intervention arm of a randomized controlled clinical trial (Children's Oncology Group; COG-ANUR0631; R01 NR008583) during hospitalization for a hematopoietic stem cell transplant.,"[{'ForeName': 'Joan E', 'Initials': 'JE', 'LastName': 'Haase', 'Affiliation': 'Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Robb', 'Affiliation': 'Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Burns', 'Affiliation': 'Indiana University Purdue University Indianapolis, Indianapolis, Indiana, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Stegenga', 'Affiliation': ""Children's Mercy Hospitals and Clinics, Kansas City, Missouri, USA.""}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Cherven', 'Affiliation': ""Children's Healthcare of Atlanta, Emory University, Atlanta, Georgia, USA.""}, {'ForeName': 'Verna', 'Initials': 'V', 'LastName': 'Hendricks-Ferguson', 'Affiliation': 'St. Louis University, St. Louis, Missouri, USA.'}, {'ForeName': 'Lona', 'Initials': 'L', 'LastName': 'Roll', 'Affiliation': 'The University of Texas Health Sciences Center, San Antonio, Texas, USA.'}, {'ForeName': 'Sharron L', 'Initials': 'SL', 'LastName': 'Docherty', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Phillips', 'Affiliation': 'Indiana University, Indianapolis, Indiana, USA.'}]",Journal of music therapy,['10.1093/jmt/thz014']
479,32251932,Predictors of anxiety and depressive symptoms among teachers in Ghana: Evidence from a randomized controlled trial.,"RATIONALE


While teachers are heralded as key drivers of student learning outcomes, little attention has been paid to teachers' mental health, especially in less-developed countries such as Ghana. Professional background, workplace environment, and personal life stressors may threaten teachers' mental health and subsequent effectiveness in the classroom.
OBJECTIVES


The objectives of this study were to investigate 1) whether and how professional background, workplace environment, and personal life stressors predicted teachers' anxiety and depressive symptoms, and 2) whether participation in a professional development intervention predicted change in teachers' symptoms over the course of one school year in Ghana.
METHOD


We used multilevel models to examine predictors of depressive and anxiety symptoms among 444 kindergarten teachers (98% female; age range: 18-69) who participated in the Quality Preschool for Ghana (QP4G) Study. QP4G was a school-randomized control trial (n = 108 public schools; n = 132 private schools) evaluating a one-year teacher professional development intervention program implemented with and without parental-awareness meetings. Teacher depressive and anxiety symptoms were assessed at baseline before the intervention and at the end of the school year.
RESULTS


Poor workplace environment was associated with increased anxiety and depressive symptoms. Social support also predicted symptoms, with lack of support from students' parents and being new to the local community associated with more anxiety symptoms. Within teachers' personal lives, household food insecurity predicted more depressive symptoms. Finally, anxiety and depressive symptoms increased for all teachers over the school year. However, randomization to either intervention was linked to a significantly smaller increase in symptoms over the school year.
CONCLUSIONS


Results suggest that teachers' personal and professional lives are consequential for their mental health, and that professional development interventions that provide training and in-class coaching and parent engagement may benefit teachers' mental health.",2020,"Social support also predicted symptoms, with lack of support from students' parents and being new to the local community associated with more anxiety symptoms.","['teachers in Ghana', ""teachers' symptoms over the course of one school year in Ghana"", 'n = 108 public schools; n = 132 private schools) evaluating a', '444 kindergarten teachers (98% female; age range: 18-69) who participated in the Quality Preschool for Ghana (QP4G) Study']","['one-year teacher professional development intervention program implemented with and without parental-awareness meetings', 'QP4G']","['Teacher depressive and anxiety symptoms', 'anxiety and depressive symptoms', 'depressive symptoms']","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0335008', 'cui_str': 'Pre-primary education teacher'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0812396,"Social support also predicted symptoms, with lack of support from students' parents and being new to the local community associated with more anxiety symptoms.","[{'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Peele', 'Affiliation': 'Population Studies Center, University of Pennsylvania, 239 McNeil Building 3718 Locust Walk, Philadelphia, PA, 19104, USA. Electronic address: mopeele@sas.upenn.edu.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Wolf', 'Affiliation': 'Graduate School of Education, University of Pennsylvania, 3700 Walnut Street, Philadelphia, PA, 9104, USA. Electronic address: wolfs@upenn.edu.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.112957']
480,31738834,Randomized multicenter trial of sirolimus vs prednisone as initial therapy for standard-risk acute GVHD: the BMT CTN 1501 trial.,"Clinical- and biomarker-based tools may identify a lower-risk acute graft-versus-host disease (GVHD) population amenable to novel, reduced-intensity treatments. Previous data suggest sirolimus may rival standard of care prednisone. We conducted a National Heart, Lung, and Blood Institute/National Cancer Institute-funded Blood and Marrow Transplant Clinical Trials Network multicenter, open-label, randomized phase 2 trial to estimate the difference in day 28 complete response (CR)/partial response (PR) rates for sirolimus vs prednisone as initial treatment of patients with standard risk (SR) acute GVHD as defined by the Minnesota (MN) GVHD Risk Score and Ann Arbor (AA1/2) biomarker status. A total of 127 MN-SR patients were randomized (1:1), and 122 were AA1/2 (sirolimus, n = 58; prednisone, n = 64). Others were AA3 (n = 4), or AA status missing (n = 1). The day 28 CR/PR rates were similar for sirolimus 64.8% (90% confidence interval [CI], 54.1%-75.5%) vs 73% (90% CI, 63.8%-82.2%) for prednisone. The day 28 rate of CR/PR with prednisone ≤0.25 mg/kg/day was significantly higher for sirolimus than prednisone (66.7% vs 31.7%; P < .001). No differences were detected in steroid-refractory acute GVHD, disease-free survival, relapse, nonrelapse mortality, or overall survival. Sirolimus was associated with reduced steroid exposure and hyperglycemia, reduced grade 2 to 3 infections, improvement in immune suppression discontinuation and patient-reported quality of life, and increased risk for thrombotic microangiopathy. For patients with clinical- and biomarker-based SR acute GVHD, sirolimus demonstrates similar overall initial treatment efficacy as prednisone. In addition, sirolimus therapy spares steroid exposure and allied toxicity, does not compromise long-term survival outcomes, and is associated with improved patient-reported quality of life. This trial was registered at www.clinicaltrials.gov as #NCT02806947.",2020,"No differences were detected in steroid-refractory acute GVHD, disease-free survival, relapse, non-relapse mortality, or overall survival.","['patients with standard risk (SR) acute GVHD', 'Standard Risk Acute GVHD', 'A total of 127 MN-SR patients were randomized (1:1), and 122 were AA1/2 ']","['sirolimus vs. prednisone', 'Sirolimus', 'Sirolimus vs. Prednisone', 'sirolimus', 'prednisone']","['complete response (CR)/partial response (PR) rates', 'steroid-refractory acute GVHD, disease-free survival, relapse, non-relapse mortality, or overall survival', 'reduced steroid exposure and hyperglycemia, reduced grade 2-3 infections, improvement in immune suppression discontinuation and patient-reported quality of life, and increased risk for thrombotic microangiopathy', 'PR rates', 'steroid exposure and allied toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034380'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2717961', 'cui_str': 'Thrombotic Microangiopathies'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",127.0,0.125604,"No differences were detected in steroid-refractory acute GVHD, disease-free survival, relapse, non-relapse mortality, or overall survival.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pidala', 'Affiliation': 'Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hamadani', 'Affiliation': 'BMT and Cellular Therapy Program, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes Corporation, Rockville, MD.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Martens', 'Affiliation': 'Emmes Corporation, Rockville, MD.'}, {'ForeName': 'Amin M', 'Initials': 'AM', 'LastName': 'Alousi', 'Affiliation': 'Department of Stem Cell Transplant and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Madan', 'Initials': 'M', 'LastName': 'Jagasia', 'Affiliation': 'Division of Hematology/Oncology, Stem Cell Transplantation, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Yvonne A', 'Initials': 'YA', 'LastName': 'Efebera', 'Affiliation': 'Blood and Marrow Transplantation Program, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Chhabra', 'Affiliation': 'BMT and Cellular Therapy Program, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Iskra', 'Initials': 'I', 'LastName': 'Pusic', 'Affiliation': 'Medical Oncology, Washington University School of Medicine in St. Louis, St. Louis, MO.'}, {'ForeName': 'Shernan G', 'Initials': 'SG', 'LastName': 'Holtan', 'Affiliation': 'Blood and Marrow Transplant Program, Departments of Pediatrics and Medicine, University of Minnesota Medical School, Minneapolis, MN.'}, {'ForeName': 'James L M', 'Initials': 'JLM', 'LastName': 'Ferrara', 'Affiliation': 'Blood and Marrow Transplantation Program, The Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Levine', 'Affiliation': 'Blood and Marrow Transplantation Program, The Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mielcarek', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': 'Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bolaños-Meade', 'Affiliation': 'Department of Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; and.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Howard', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Brent R', 'Initials': 'BR', 'LastName': 'Logan', 'Affiliation': 'BMT and Cellular Therapy Program, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Leifer', 'Affiliation': 'Office of Biostatistics Research, National Heart, Lung, and Blood Institute, Bethesda, MD.'}, {'ForeName': 'Theresa S', 'Initials': 'TS', 'LastName': 'Pritchard', 'Affiliation': 'Emmes Corporation, Rockville, MD.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': 'BMT and Cellular Therapy Program, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'MacMillan', 'Affiliation': 'Blood and Marrow Transplant Program, Departments of Pediatrics and Medicine, University of Minnesota Medical School, Minneapolis, MN.'}]",Blood,['10.1182/blood.2019003125']
481,32001213,"Corrigendum to ""Rationale and design of the Study To Understand Fall Reduction and Vitamin D in You (STURDY): A randomized clinical trial of Vitamin D supplement doses for the prevention of falls in older adults"" [Contemp Clin Trials. 73 (2018) 111-122].",,2020,,"['older adults"" [Contemp Clin Trials']",['Vitamin D supplement'],['Fall Reduction and Vitamin D in You (STURDY'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}]","[{'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]",,0.189991,,"[{'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Michos', 'Affiliation': 'Division of Cardiology, Johns Hopkins School of Medicine, Baltimore, MD, United States; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, United States. Electronic address: edonnell@jhmi.edu.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Mitchell', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, United States; Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Sternberg', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, United States; Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States; Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Schrack', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, United States; Center on Aging and Health, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Szanton', 'Affiliation': 'Center on Aging and Health, Johns Hopkins University, Baltimore, MD, United States; Johns Hopkins School of Nursing, Baltimore, MD, United States; Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Walston', 'Affiliation': 'Center on Aging and Health, Johns Hopkins University, Baltimore, MD, United States; Division of Geriatric Medicine and Gerontology, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Rita R', 'Initials': 'RR', 'LastName': 'Kalyani', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; Center on Aging and Health, Johns Hopkins University, Baltimore, MD, United States; Division of Endocrinology, Diabetes, and Metabolism, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Plante', 'Affiliation': 'Department of Medicine, Larner College of Medicine at the University of Vermont, Burlington, VT, United States.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Christenson', 'Affiliation': 'Department of Pathology, University of Maryland Medical Center, Baltimore, MD, United States.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Shade', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Roth', 'Affiliation': 'Center on Aging and Health, Johns Hopkins University, Baltimore, MD, United States; Division of Geriatric Medicine and Gerontology, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, United States; Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.105936']
482,31957334,Clinical Trial Simulation To Optimize Trial Design for Fludarabine Dosing Strategies in Allogeneic Hematopoietic Cell Transplantation.,"Optimal fludarabine exposure has been associated with improved treatment outcome in allogeneic hematopoietic cell transplantation, suggesting potential benefit of individualized dosing. A randomized controlled trial (RCT) comparing alternative fludarabine dosing strategies to current practice may be warranted, but should be sufficiently powered for a relevant end point, while still feasible to enroll. To find the optimal design, we simulated RCTs comparing current practice (160 mg/m 2  ) to either covariate-based or therapeutic drug monitoring (TDM)-guided dosing with potential outcomes being nonrelapse mortality (NRM), graft failure, or relapse, and ultimately overall survival (covering all three aforementioned outcomes). The inclusion in each treatment arm (n) required to achieve 80% power was calculated for all combinations of end points and dosing comparisons. The trial requiring the lowest n for sufficient power compared TDM-guided dosing to current practice with NRM as primary outcome (n = 70, NRM decreasing from 21% to 5.7%). We conclude that a superiority trial is feasible.",2020,The inclusion in each treatment arm (n) required to achieve 80% power was calculated for all combinations of endpoints and dosing comparisons.,"['allogeneic hematopoietic cell transplantation (HCT', 'allogeneic hematopoietic cell transplantation']",['fludarabine'],"['relapse mortality (NRM), graft failure, or relapse, and ultimately overall survival (OS']","[{'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]","[{'cui': 'C0059985', 'cui_str': 'fludarabine'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0895835,The inclusion in each treatment arm (n) required to achieve 80% power was calculated for all combinations of endpoints and dosing comparisons.,"[{'ForeName': 'Jurgen B', 'Initials': 'JB', 'LastName': 'Langenhorst', 'Affiliation': 'Pediatric Blood and Marrow Transplant Program, Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands.'}, {'ForeName': 'Thomas P C', 'Initials': 'TPC', 'LastName': 'Dorlo', 'Affiliation': 'Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'van Kesteren', 'Affiliation': 'Pediatric Blood and Marrow Transplant Program, Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands.'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'van Maarseveen', 'Affiliation': 'Department of Clinical Pharmacy, University Medical Centre Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Nierkens', 'Affiliation': 'Pediatric Blood and Marrow Transplant Program, Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands.'}, {'ForeName': 'Moniek A', 'Initials': 'MA', 'LastName': 'de Witte', 'Affiliation': 'Department of Hematology, University Medical Centre Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jaap Jan', 'Initials': 'JJ', 'LastName': 'Boelens', 'Affiliation': 'Pediatric Blood and Marrow Transplant Program, Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands.'}, {'ForeName': 'Alwin D R', 'Initials': 'ADR', 'LastName': 'Huitema', 'Affiliation': 'Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12486']
483,30156338,A randomised crossover trial comparing nasal masks with oronasal masks: No differences in therapeutic pressures or residual apnea-hypopnea indices.,"In treating obstructive sleep apnea (OSA), the use of oronasal masks with continuous positive airway pressure (CPAP) has been reported to increase pressure levels and reduce compliance. These reports come mostly from large observational studies. In this study, we examined the impact that oronasal masks have on 95th centile pressures, the residual apnea-hypopnea index (AHI) and compliance compared with nasal masks. A randomised crossover design was implemented. Participants already established on CPAP were randomly allocated to a nasal mask or oronasal mask with auto-titrating positive airway pressure (APAP) for 2 weeks. Participants then crossed over to use the alternate mask for another 2 weeks. Seventy-one participants were recruited but only 60 completed the trial. There were no differences in median 95th centile pressure (nasal, 11.5 cm H 2  O; oronasal, 11.7 cm H 2  O; p = 0.115), median residual AHI (nasal, 4.9 events/hr; oronasal, 5.3 events/hr; p = 0.234) or median compliance (nasal, 7.3 hr/night; oronasal, 7.3 hr/night; p = 0.961). Only four patients had 95th centile pressures that were at least 1.5 cm H 2  O greater with oronasal masks. Oronasal masks do not systematically increase therapeutic CPAP requirements. Rather, a small subset of patients display significant differences in CPAP levels.",2019,Only four patients had 95th centile pressures that were at least 1.5 cm H 2  O greater with oronasal masks.,"['Participants already established on CPAP', 'obstructive sleep apnea (OSA', 'Seventy-one participants were recruited but only 60 completed the trial']","['nasal mask or oronasal mask with auto-titrating positive airway pressure (APAP', 'nasal masks with oronasal masks', 'oronasal masks with continuous positive airway pressure (CPAP']","['therapeutic pressures or residual apnea-hypopnea indices', 'median compliance', 'CPAP levels', 'residual apnea-hypopnea index (AHI) and compliance', 'median residual AHI', 'therapeutic CPAP requirements', 'median 95th centile pressure']","[{'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C2711254', 'cui_str': 'Dental mask'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",71.0,0.0225112,Only four patients had 95th centile pressures that were at least 1.5 cm H 2  O greater with oronasal masks.,"[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Shirlaw', 'Affiliation': 'Sleep Disorders Centre, Department of Respiratory and Sleep Medicine, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Duce', 'Affiliation': 'Sleep Disorders Centre, Department of Respiratory and Sleep Medicine, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Milosavljevic', 'Affiliation': 'Sleep Disorders Centre, Department of Respiratory and Sleep Medicine, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Hanssen', 'Affiliation': 'Sleep Disorders Centre, Department of Respiratory and Sleep Medicine, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Hukins', 'Affiliation': 'Sleep Disorders Centre, Department of Respiratory and Sleep Medicine, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}]",Journal of sleep research,['10.1111/jsr.12760']
484,32307560,Intrinsic connections between thalamic sub-regions and the lateral prefrontal cortex are differentially impacted by acute methylphenidate.,"BACKGROUND


The thalamus is a major target of dopaminergic projections and is densely connected with the prefrontal cortex. A better understanding of how dopamine changes thalamo-cortical communication may shed light on how dopamine supports cognitive function. Methylphenidate has been shown to facilitate cognitive processing and reduce connectivity between the thalamus and lateral prefrontal cortex.
AIMS


The thalamus is a heterogeneous structure, and the present study sought to clarify how the intrinsic connections of thalamic sub-regions are differentially impacted by acute dopamine transporter blockade.
METHODS


Sixty healthy volunteers were orally administered either 20 mg of methylphenidate (N = 29) or placebo (N = 31) in a double-blind, randomized, between-subject design. Multi-echo fMRI was used to assess intrinsic functional connectivity of sub-regions of the thalamus during a resting state scan. An N-back working-memory paradigm provided a measure of cognitive performance.
RESULTS


Acute methylphenidate significantly reduced connectivity of the lateral prefrontal cortex with the motor and somatosensory sub-regions of the thalamus and reduced connectivity with the parietal and visual sub-regions at a trend level. Connectivity with the premotor, prefrontal, and temporal sub-regions was not impacted. The intrinsic connectivity between the thalamus and the lateral prefrontal cortex was not associated with working-memory performance.
CONCLUSIONS


Methylphenidate decreases functional connections between the lateral prefrontal cortex and thalamus broadly, while sparing intrinsic connectivity with thalamic sub-regions involved with working-memory and language related processes. Collectively, our results suggest that the dopamine transporter regulates functional connections between the prefrontal cortex and non-cognitive areas of the thalamus.",2020,"Connectivity with the premotor, prefrontal, and temporal sub-regions was not impacted.",['Sixty healthy volunteers'],"['Methylphenidate', '20\xa0mg of methylphenidate (N\u2009=\u200929) or placebo']",['connectivity of the lateral prefrontal cortex'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",60.0,0.0421953,"Connectivity with the premotor, prefrontal, and temporal sub-regions was not impacted.","[{'ForeName': 'Adam X', 'Initials': 'AX', 'LastName': 'Gorka', 'Affiliation': 'Section on the Neurobiology of Fear & Anxiety, National Institute of Mental Health, 15K North Drive Rm 300-F, Bethesda, MD, 20892, USA. adam.gorka@nih.gov.'}, {'ForeName': 'Tiffany R', 'Initials': 'TR', 'LastName': 'Lago', 'Affiliation': 'Section on the Neurobiology of Fear & Anxiety, National Institute of Mental Health, 15K North Drive Rm 300-F, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Balderston', 'Affiliation': 'Section on the Neurobiology of Fear & Anxiety, National Institute of Mental Health, 15K North Drive Rm 300-F, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Torrisi', 'Affiliation': 'Section on the Neurobiology of Fear & Anxiety, National Institute of Mental Health, 15K North Drive Rm 300-F, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Bari', 'Initials': 'B', 'LastName': 'Fuchs', 'Affiliation': 'Department of Nutritional Sciences, Penn State University, State College, PA, 16801, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Section on the Neurobiology of Fear & Anxiety, National Institute of Mental Health, 15K North Drive Rm 300-F, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'Section on the Neurobiology of Fear & Anxiety, National Institute of Mental Health, 15K North Drive Rm 300-F, Bethesda, MD, 20892, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05505-z']
485,31443102,Colonization by B. infantis EVC001 modulates enteric inflammation in exclusively breastfed infants.,"BACKGROUND


Infant gut dysbiosis, often associated with low abundance of bifidobacteria, is linked to impaired immune development and inflammation-a risk factor for increased incidence of several childhood diseases. We investigated the impact of B. infantis EVC001 colonization on enteric inflammation in a subset of exclusively breastfed term infants from a larger clinical study.
METHODS


Stool samples (n = 120) were collected from infants randomly selected to receive either 1.8 × 10 10  CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal. The fecal microbiome was analyzed using 16S ribosomal RNA, proinflammatory cytokines using multiplexed immunoassay, and fecal calprotectin using ELISA at three time points: days 6 (Baseline), 40, and 60 postnatal.
RESULTS


Fecal calprotectin concentration negatively correlated with Bifidobacterium abundance (P < 0.0001; ρ = -0.72), and proinflammatory cytokines correlated with Clostridiaceae and Enterobacteriaceae, yet negatively correlated with Bifidobacteriaceae abundance. Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
CONCLUSION


Our findings indicate that gut dysbiosis (absence of B. infantis) is associated with increased intestinal inflammation. Early addition of EVC001 to diet represents a novel strategy to prevent enteric inflammation during a critical developmental phase.",2019,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
","['exclusively breastfed infants', 'Stool samples (n\u2009=\u2009120']","['CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal']","['Proinflammatory cytokines', 'intestinal inflammation', 'fecal microbiome', 'Fecal calprotectin concentration', 'enteric inflammation', 'proinflammatory cytokines']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1550661', 'cui_str': 'Feces specimen'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C3889047', 'cui_str': 'Intestinal inflammation'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",1010.0,0.0603489,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
","[{'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Henrick', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA. bhenrick2@unl.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chew', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Casaburi', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Brown', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Frese', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Morrison Microscopy Core Research Facility, University of Nebraska, Lincoln, NE, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Smilowitz', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}]",Pediatric research,['10.1038/s41390-019-0533-2']
486,31362591,Disparities in Socioeconomic Context and Association With Blood Pressure Control and Cardiovascular Outcomes in ALLHAT.,"Background Observational studies demonstrate that communities of low socioeconomic status have higher blood pressure and worse cardiovascular outcomes. Yet, whether the clinical outcomes resulting from antihypertensive therapy vary by socioeconomic context in a randomized clinical trial, in which participants are treated under a standard protocol, is unknown. Methods and Results We used data from ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) to study the effect of socioeconomic context, defined as the county-level median household income, of study sites. We stratified sites into income quintiles and compared characteristics, blood pressure control, and cardiovascular outcomes among ALLHAT participants in the lowest- and highest-income quintiles. Among 27 862 qualifying participants, 2169 (7.8%) received care in the lowest-income sites (quintile 1) and 10 458 (37.6%) received care in the highest-income sites (quintile 5). Participants in quintile 1 were more likely to be women, to be black, to be Hispanic, to have fewer years of education, to live in the South, and to have fewer cardiovascular risk factors. After adjusting for baseline demographic and clinical characteristics, quintile 1 participants were less likely to achieve blood pressure control (<140/90 mm Hg) (odds ratio, 0.48; 95% CI, 0.37-0.63) and had greater all-cause mortality (hazard ratio [HR], 1.25; 95% CI, 1.10-1.41), heart failure hospitalizations/mortality (HR, 1.26; 95% CI, 1.03-1.55), and end-stage renal disease (HR, 1.86; 95% CI, 1.26-2.73), but lower angina hospitalizations (HR, 0.70; 95% CI, 0.59-0.83) and coronary revascularizations (HR, 0.71; 95% CI, 0.57-0.89). Conclusions Despite standardized treatment protocols, ALLHAT participants in the lowest-income sites experienced poorer blood pressure control and worse outcomes for some adverse cardiovascular events, emphasizing the importance of measuring and addressing socioeconomic context. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00000542.",2019,"ALLHAT participants in the lowest-income sites experienced poorer blood pressure control and worse outcomes for some adverse cardiovascular events, emphasizing the importance of measuring and addressing socioeconomic context.","['Among 27\xa0862 qualifying participants, 2169 (7.8%) received care in the lowest-income sites (quintile 1) and 10\xa0458 (37.6%) received care in the highest-income sites (quintile 5']",['ALLHAT (Antihypertensive and Lipid-Lowering Treatment'],"['blood pressure control, and cardiovascular outcomes', 'heart failure hospitalizations/mortality', 'angina hospitalizations', 'blood pressure control', 'coronary revascularizations', 'blood pressure control ', 'cause mortality', 'blood pressure and worse cardiovascular outcomes']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0948433', 'cui_str': 'High income'}]","[{'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]",,0.206748,"ALLHAT participants in the lowest-income sites experienced poorer blood pressure control and worse outcomes for some adverse cardiovascular events, emphasizing the importance of measuring and addressing socioeconomic context.","[{'ForeName': 'Andi', 'Initials': 'A', 'LastName': 'Shahu', 'Affiliation': 'Department of Medicine Johns Hopkins Hospital Baltimore MD.'}, {'ForeName': 'Jeph', 'Initials': 'J', 'LastName': 'Herrin', 'Affiliation': 'Section\xa0of Cardiovascular Medicine Department of Internal Medicine Yale School of Medicine New Haven CT.'}, {'ForeName': 'Sanket S', 'Initials': 'SS', 'LastName': 'Dhruva', 'Affiliation': 'San Francisco Veterans Affairs Medical Center San Francisco CA.'}, {'ForeName': 'Nihar R', 'Initials': 'NR', 'LastName': 'Desai', 'Affiliation': 'Section\xa0of Cardiovascular Medicine Department of Internal Medicine Yale School of Medicine New Haven CT.'}, {'ForeName': 'Barry R', 'Initials': 'BR', 'LastName': 'Davis', 'Affiliation': 'Coordinating Center for Clinical Trials University of Texas School of Public Health Houston TX.'}, {'ForeName': 'Harlan M', 'Initials': 'HM', 'LastName': 'Krumholz', 'Affiliation': 'Section\xa0of Cardiovascular Medicine Department of Internal Medicine Yale School of Medicine New Haven CT.'}, {'ForeName': 'Erica S', 'Initials': 'ES', 'LastName': 'Spatz', 'Affiliation': 'Section\xa0of Cardiovascular Medicine Department of Internal Medicine Yale School of Medicine New Haven CT.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.012277']
487,31400518,Scalability of cancer SurvivorLink™: A cluster randomized trial among pediatric cancer clinics.,"BACKGROUND


Children diagnosed with cancer are living longer and the survivor population is growing. However, most survivors develop late effects of radiation and chemotherapy shortly to years after completion of therapy, and the receipt of follow-up visits that are recommended by the Children's Oncology Group (COG) is suboptimal nationally.
AIMS


The aims of this study are to: 1) evaluate the impact of a patient-controlled electronic personal health record (ePHR) and system (SurvivorLink) on care visit attendance, risk-based surveillance, and other secondary outcomes (i.e., patient activation, quality of life (QOL)); 2) measure the use, acceptability, and perceived usefulness of, and satisfaction with SurvivorLink; and 3) assess facilitators and barriers to implementation.
METHODS


This hybrid effectiveness-implementation, clustered randomized control trial (RCT) evaluates the effect of SurvivorLink among pediatric cancer survivors and their parents on receipt of follow-up cancer care. We will recruit 20 pediatric survivor clinics with half receiving the intervention and half acting as a waitlist control. Parents of survivors and survivors will complete baseline, 3 and 12 month surveys that assess SurvivorLink use, patient self-efficacy, and intentions to return for follow-up. We will use mixed methods and multi-informant assessment to assess implementation outcomes (i.e., acceptability, feasibility, appropriateness).
DISCUSSION


New approaches are needed to facilitate the receipt of long-term follow-up care among pediatric cancer survivors. This study will assess whether SurvivorLink is effective in increasing receipt of follow-up cancer care. Moreover, it will explore the influences of context and other moderators of clinical practice change in pediatric cancer survivorship.",2019,"This hybrid effectiveness-implementation, clustered randomized control trial (RCT) evaluates the effect of SurvivorLink among pediatric cancer survivors and their parents on receipt of follow-up cancer care.","['pediatric cancer clinics', 'pediatric cancer survivors and their parents on receipt of follow-up cancer care', 'Scalability of cancer SurvivorLink™', '20 pediatric survivor clinics with half receiving the intervention and half acting as a waitlist control', 'pediatric cancer survivors']","['patient-controlled electronic personal health record (ePHR) and system (SurvivorLink', 'SurvivorLink']","['care visit attendance, risk-based surveillance, and other secondary outcomes (i.e., patient activation, quality of life (QOL)); 2) measure the use, acceptability, and perceived usefulness of, and satisfaction with SurvivorLink; and 3) assess facilitators and barriers to implementation']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0018739', 'cui_str': 'Personal Health Records'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.0903792,"This hybrid effectiveness-implementation, clustered randomized control trial (RCT) evaluates the effect of SurvivorLink among pediatric cancer survivors and their parents on receipt of follow-up cancer care.","[{'ForeName': 'Cam', 'Initials': 'C', 'LastName': 'Escoffery', 'Affiliation': 'Rollins School of Public Health, Emory, 1518 Clifton Road, Atlanta, GA 30322, USA. Electronic address: cescoff@emory.edu.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Gilleland Marchak', 'Affiliation': ""Department of Pediatrics, Emory University; Aflac Cancer and Blood Disorder Center, Children's Healthcare of Atlanta, 1405 Clifton Rd, Atlanta, GA 30322, USA. Electronic address: jgillel@emory.edu.""}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Haardörfer', 'Affiliation': 'Rollins School of Public Health, Emory, 1518 Clifton Road, Atlanta, GA 30322, USA. Electronic address: regine.haardoerfer@emory.edu.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Meacham', 'Affiliation': ""Department of Pediatrics, Emory University; Aflac Cancer and Blood Disorder Center, Children's Healthcare of Atlanta, 1405 Clifton Rd, Atlanta, GA 30322, USA. Electronic address: lillian.meacham@emory.edu.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Williamson Lewis', 'Affiliation': ""Aflac Cancer and Blood Disorder Center, Children's Healthcare of Atlanta, 1405 Clifton Rd, Atlanta, GA 30322, USA. Electronic address: rebecca.lewis@choa.org.""}, {'ForeName': 'Hallie', 'Initials': 'H', 'LastName': 'Udelson', 'Affiliation': 'Rollins School of Public Health, Emory, 1518 Clifton Road, Atlanta, GA 30322, USA. Electronic address: hallie.udelson@emory.edu.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Edwards', 'Affiliation': 'Himformatics, 1579 Monroe Drive NE, Suite 410, Atlanta, GA 30324, USA. Electronic address: pedwards@himformatics.com.'}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Mertens', 'Affiliation': ""Department of Pediatrics, Emory University; Aflac Cancer and Blood Disorder Center, Children's Healthcare of Atlanta, 1405 Clifton Rd, Atlanta, GA 30322, USA. Electronic address: amerten@emory.edu.""}]",Contemporary clinical trials,['10.1016/j.cct.2019.105819']
488,32307658,A randomized phase II trial evaluating two non-pharmacologic interventions in cancer survivors for the treatment of sleep-wake disturbances: NCCTG N07C4 (Alliance).,"PURPOSE


Sleep disturbance is a prevalent problem for cancer survivors and effective behavioral treatments are not widely used for this population. This study evaluated home-based sleep interventions based on cognitive behavioral therapy for insomnia (CBT-I).
METHODS


This phase II randomized controlled trial evaluated two manualized interventions over 7 weeks. The intervention group received sleep hygiene information, stimulus control, sleep restriction, and a bedtime imagery audio recording. The control group was similar, but without sleep restriction and used audio recordings of bedtime short stories instead of imagery. Eligibility included adult cancer survivors who had trouble falling asleep or falling back to sleep on 3 of 7 days. Patients with diagnoses of sleep or mental health disorders were excluded. The primary endpoint was change in time to fall asleep or falling back to sleep after awakening, from baseline to week 7. Two-sample T tests evaluated differences between arms for this endpoint.
RESULTS


Ninety-three of 168 planned participants were enrolled from 20 institutions. The study closed early for poor accrual. Baseline time to sleep was 45 min and 52 min for the intervention and control group, respectively. At 7 weeks, both groups improved, the intervention group to 26 min and control group to 30 min, a non-significant difference between groups (p = 0.85). Secondary outcomes improved in both groups with no significant differences between arms.
CONCLUSIONS


Improvement in sleep outcomes in both arms was consistent with other CBT-I interventions delivered through alternative approaches to provider-delivered therapy. More research on optimal scalable delivery of CBT-I is needed.
CLINICAL RELEVANCE


This study supports the effectiveness of CBT-I based behavioral interventions for sleep but also the need for better delivery methods to improve uptake and effect size.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00993928.",2020,"At 7 weeks, both groups improved, the intervention group to 26 min and control group to 30 min, a non-significant difference between groups (p = 0.85).","['Patients with diagnoses of sleep or mental health disorders', 'Ninety-three of 168 planned participants were enrolled from 20 institutions', 'cancer survivors for the treatment of sleep-wake disturbances: NCCTG N07C4 (Alliance', 'Eligibility included adult cancer survivors who had trouble falling asleep or falling back to sleep on 3 of 7\xa0days']","['home-based sleep interventions based on cognitive behavioral therapy', 'sleep hygiene information, stimulus control, sleep restriction, and a bedtime imagery audio recording', 'CBT-I based behavioral interventions']","['change in time to fall asleep or falling back to sleep', 'sleep outcomes', 'Baseline time to sleep']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0393760', 'cui_str': 'Initial insomnia'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0871436', 'cui_str': 'Stimulus control'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.0861286,"At 7 weeks, both groups improved, the intervention group to 26 min and control group to 30 min, a non-significant difference between groups (p = 0.85).","[{'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Barton', 'Affiliation': 'University of Michigan School of Nursing, 400 N. Ingalls, Room 4320, Ann Arbor, MI, 48109-5482, USA. debbartn@med.umich.edu.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Daniel V', 'Initials': 'DV', 'LastName': 'Satele', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Qin', 'Affiliation': 'Janssen Pharmaceuticals, Raritan, NJ, Belgium.'}, {'ForeName': 'Shaker', 'Initials': 'S', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP, Wichita, KS, USA.'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Pipe', 'Affiliation': 'Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hobday', 'Affiliation': 'Mayo Clinic Cancer Center, Rochester, MN, USA.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Fee-Schroeder', 'Affiliation': 'Mayo Clinic Cancer Center, Rochester, MN, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'Mayo Clinic Cancer Center, Rochester, MN, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05461-6']
489,31687984,Effects of Elastic Resistance Exercise After Total Knee Replacement on Muscle Mass and Physical Function in Elderly Women With Osteoarthritis: A Randomized Controlled Trial.,"OBJECTIVE


Knee osteoarthritis and age are associated with high sarcopenia risk, especially in patients who have received total knee replacement. The aim of this study was to identify the effects of elastic resistance exercise training after total knee replacement on muscle mass and physical outcomes in older women with knee osteoarthritis.
DESIGN


Sixty older women who received unilateral primary total knee replacement surgery were randomized to an experimental group, which received 12 wks of postoperative elastic resistance exercise training, or a control group, which received standard care. The outcome measures included physical function performance (ie, Timed Up & Go, gait speed, forward reach, single-leg stance, timed chair rise), appendicular lean mass, and the Western Ontario and McMaster Universities Osteoarthritis Index. The assessment time points were 2 wks before surgery (T0), 1 mo after surgery (T1, before resistance exercise training), and 4 mos after surgery (T2, upon completion of resistance exercise training).
RESULTS


After 12 wks of postoperative elastic resistance exercise training, the experimental group exhibited a significantly greater change in appendicular lean mass (mean difference = 0.81 kg, P = 0.004) than the control group. Elastic resistance exercise training also exerted significant effects on Timed Up & Go and gait speed with mean differences of 0.28 m/sec (P < 0.001) and -2.66 secs (P < 0.001), respectively.
CONCLUSIONS


A 12-wk elastic resistance exercise training program after total knee replacement exerted benefits on muscle mass, mobility, and Western Ontario and McMaster Universities Osteoarthritis Index functional outcomes in older women with knee osteoarthritis.",2020,"A 12-week elastic RET program after TKR exerted benefits on muscle mass, mobility, and WOMAC functional outcomes in older women with KOA.","['older women with KOA', 'elderly women with osteoarthritis', 'older women with KOA.Sixty older women who received unilateral primary TKR surgery', 'patients who have received total knee replacement (TKR']","['postoperative elastic RET, or a control group (CG), which received standard care', 'TKR', 'elastic resistance exercise training (RET', 'elastic resistance exercise']","['muscle mass and physical outcomes', 'physical function performance (i.e., Timed Up & Go [TUG], gait speed [GS], forward reach, single-leg stance, timed chair rise), appendicular lean mass (ALM), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC', 'muscle mass and physical function', 'muscle mass, mobility, and WOMAC functional outcomes', 'ALM']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0379555,"A 12-week elastic RET program after TKR exerted benefits on muscle mass, mobility, and WOMAC functional outcomes in older women with KOA.","[{'ForeName': 'Chun-De', 'Initials': 'CD', 'LastName': 'Liao', 'Affiliation': 'From the School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan (C-DL, J-YT); Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan (C-DL, S-WH, T-HL); Department of Orthopedics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan (Y-SC); Department of Radiology, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan (J-WK); Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan, Taiwan (S-WH); and Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan (S-WH, T-HL).'}, {'ForeName': 'Jau-Yih', 'Initials': 'JY', 'LastName': 'Tsauo', 'Affiliation': ''}, {'ForeName': 'Yen-Shuo', 'Initials': 'YS', 'LastName': 'Chiu', 'Affiliation': ''}, {'ForeName': 'Jan-Wen', 'Initials': 'JW', 'LastName': 'Ku', 'Affiliation': ''}, {'ForeName': 'Shih-Wei', 'Initials': 'SW', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Tsan-Hon', 'Initials': 'TH', 'LastName': 'Liou', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001344']
490,31041545,Withdrawal of thiopurines in Crohn's disease treated with scheduled adalimumab maintenance: a prospective randomised clinical trial (DIAMOND2).,"BACKGROUND


The risk:benefit ratio of concomitant use of thiopurines with scheduled adalimumab (ADA) maintenance therapy for Crohn's disease is controversial. The aim of this study is to identify the influence of withdrawal of thiopurines in patients in remission with combination therapy in an open-label, randomised, controlled trial (DIAMOND2; UMIN000009596).
METHODS


Patients in corticosteroid-free clinical remission (CFCR) for ≥ 6 months with ADA (40 mg, s.c., every other week) scheduled maintenance combined with thiopurines were randomised into two groups, ""continue"" (Con) or ""discontinue"" (Dis) group of thiopurines, whereas all other patients kept receiving scheduled ADA maintenance therapy for 52 weeks. The primary endpoint was the proportion of patients in CFCR at week 52. Secondary endpoints were endoscopic remission (ER), trough levels of ADA in serum, and safety.
RESULTS


Fifty patients were randomised to Con or Dis groups. Characteristics of patients were not significantly different between the groups. CFCR and ER prevalence at week 52 were not significantly different between groups (log rank, P = 0.704, P = 1.000, respectively). Trough levels of ADA were not significantly different between groups (P = 0.515). The proportion of patients with AAA positivity at week 52 was not significantly different (P = 0.437). ER at week 0 was involved in ER and triple remission at week 52. No serious adverse effects were observed in either group.
CONCLUSION


Continuation of thiopurines > 6 months offers no clear benefit over scheduled ADA monotherapy. CFCR, ER, and ADA trough level at week 52 were not significantly different between groups. ER at week 0 may be involved in better long-term clinical outcomes.",2019,"CFCR and ER prevalence at week 52 were not significantly different between groups (log rank, P = 0.704, P = 1.000, respectively).","['patients in remission with combination therapy in an open-label', 'Fifty patients', ""Crohn's disease treated with scheduled adalimumab maintenance"", 'Patients in corticosteroid-free clinical remission (CFCR) for\u2009≥']","['continue"" (Con) or ""discontinue"" (Dis) group of thiopurines, whereas all other patients kept receiving scheduled ADA maintenance therapy', 'thiopurines with scheduled adalimumab (ADA) maintenance therapy', 'thiopurines', 'ADA', 'Withdrawal of thiopurines']","['serious adverse effects', 'CFCR and ER prevalence', 'Trough levels of ADA', 'proportion of patients in CFCR', 'CFCR, ER, and ADA trough level', 'proportion of patients with AAA positivity', 'endoscopic remission (ER), trough levels of ADA in serum, and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",50.0,0.167078,"CFCR and ER prevalence at week 52 were not significantly different between groups (log rank, P = 0.704, P = 1.000, respectively).","[{'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Hisamatsu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Third Department of Internal Medicine, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka-shi, Tokyo, 181-8611, Japan. thisamatsu@ks.kyorin-u.ac.jp.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Saitama Medical Centre, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Kunisaki', 'Affiliation': 'Inflammatory Bowel Disease Centre, Yokohama City University Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Matsuura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Nagahori', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Motoya', 'Affiliation': 'Inflammatory Bowel Disease Center, Sapporo Kosei General Hospital, Sapporo, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Esaki', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Norimasa', 'Initials': 'N', 'LastName': 'Fukata', 'Affiliation': 'Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': 'Departments of Gastroenterology, Kobe City Medical Center General Hospital, Hyogo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sugaya', 'Affiliation': 'Department of Internal Medicine, Japan Red Cross Ashikaga Hospital, Tochigi, Japan.'}, {'ForeName': 'Hirotake', 'Initials': 'H', 'LastName': 'Sakuraba', 'Affiliation': 'Department of Gastroenterology and Hematology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Fumihito', 'Initials': 'F', 'LastName': 'Hirai', 'Affiliation': 'Inflammatory Bowel Disease Center, Fukuoka University Chikushi Hospital, Chikushino, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Division of Gastroenterology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Kanai', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Naganuma', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nakase', 'Affiliation': 'Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hibi', 'Affiliation': 'Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Nojima', 'Affiliation': 'Center for Translational Research, Institute of Medical Science Hospital, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Iwate Medical University, Morioka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of gastroenterology,['10.1007/s00535-019-01582-w']
491,31307270,Effect of Intensive and Standard Clinic-Based Hypertension Management on the Concordance Between Clinic and Ambulatory Blood Pressure and Blood Pressure Variability in SPRINT.,"Background Blood pressure ( BP ) varies over time within individual patients and across different BP measurement techniques. The effect of different BP targets on concordance between BP measurements is unknown. The goals of this analysis are to evaluate concordance between (1) clinic and ambulatory BP , (2) clinic visit-to-visit variability and ambulatory BP variability, and (3) first and second ambulatory BP and to evaluate whether different clinic targets affect these relationships. Methods and Results The SPRINT (Systolic Blood Pressure Intervention Trial) ambulatory BP monitoring ancillary study obtained ambulatory BP readings in 897 participants at the 27-month follow-up visit and obtained a second reading in 203 participants 293±84 days afterward. There was considerable lack of agreement between clinic and daytime ambulatory systolic BP with wide limits of agreement in Bland-Altman plots of -21 to 34 mm Hg in the intensive-treatment group and -26 to 32 mm Hg in the standard-treatment group. Overall, there was poor agreement between clinic visit-to-visit variability and ambulatory BP variability with correlation coefficients for systolic and diastolic BP all <0.16. We observed a high correlation between first and second ambulatory BP ; however, the limits of agreement were wide in both the intensive group (-27 to 21 mm Hg) and the standard group (-23 to 20 mm Hg). Conclusions We found low concordance in BP and BP variability between clinic and ambulatory BP and second ambulatory BP . Results did not differ by treatment arm. These results reinforce the need for multiple BP measurements before clinical decision making.",2019,Results did not differ by treatment arm.,['897 participants at the 27-month follow-up visit and obtained a second reading in 203 participants 293±84\xa0days afterward'],['Intensive and Standard Clinic-Based Hypertension Management'],"['BP and BP variability between clinic and ambulatory BP and second ambulatory BP ', ' Blood pressure ( BP ', 'concordance between (1) clinic and ambulatory BP , (2) clinic visit-to-visit variability and ambulatory BP variability, and (3) first and second ambulatory BP', 'clinic visit-to-visit variability and ambulatory BP variability with correlation coefficients for systolic and diastolic BP', 'daytime ambulatory systolic BP', 'Concordance Between Clinic and Ambulatory Blood Pressure and Blood Pressure Variability']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}]",897.0,0.0254439,Results did not differ by treatment arm.,"[{'ForeName': 'Lama', 'Initials': 'L', 'LastName': 'Ghazi', 'Affiliation': '1 Division of Public Health Department of Epidemiology and Community Health University of Minnesota Minneapolis MN.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': '2 Division of Public Health Sciences Department of Biostatistical Sciences Wake Forest School of Medicine Winston-Salem NC.'}, {'ForeName': 'Dena E', 'Initials': 'DE', 'LastName': 'Rifkin', 'Affiliation': '3 Division of Nephrology Veterans Affairs Health System and University of California San Diego CA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': '4 Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine Houston TX.'}, {'ForeName': 'Tara I', 'Initials': 'TI', 'LastName': 'Chang', 'Affiliation': '5 Division of Nephrology Stanford University School of Medicine Palo Alto CA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': '6 Memphis Veterans Affairs Medical Center Memphis TN.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Glasser', 'Affiliation': '7 Division of Cardiology Department of Internal Medicine University of Kentucky College of Medicine Lexington KY.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': '8 Division of Nephrology and Hypertension Mayo Clinic Jacksonville FL.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': '9 Department of Preventive Medicine University of Tennessee Health Science Center Memphis TN.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kostis', 'Affiliation': '10 Division of Cardiovascular Disease and Hypertension Rutgers Robert Wood Johnson Medical School New Brunswick NJ.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Papademetriou', 'Affiliation': '11 Department of Veterans Affairs and Georgetown University Washington DC.'}, {'ForeName': 'Mahboob', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': '12 Case Western Reserve University University Hospitals Cleveland Medical Center Louis Stokes Cleveland VA Medical Center Cleveland OH.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Simmons', 'Affiliation': '13 Department of Internal Medicine University of Utah Salt Lake City UT.'}, {'ForeName': 'Addison', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': '4 Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine Houston TX.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': '15 Tulane University School of Public Health and Tropical Medicine New Orleans LA.'}, {'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Wright', 'Affiliation': '16 Clinical Hypertension Program Division of Nephrology and Hypertension University Hospitals Cleveland Medical Center Cleveland OH.'}, {'ForeName': 'Udayan Y', 'Initials': 'UY', 'LastName': 'Bhatt', 'Affiliation': '17 Division of Nephrology The Ohio State University, Wexner Medical Center Columbus OH.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Drawz', 'Affiliation': '18 Division of Renal Diseases and Hypertension University of Minnesota Minneapolis MN.'}]",Journal of the American Heart Association,['10.1161/JAHA.118.011706']
492,31347430,Acute Aspirin Plus Cilostazol Dual Therapy for Noncardioembolic Stroke Patients Within 48 Hours of Symptom Onset.,"Background The aim of the present study was to investigate the efficacy and safety of antiplatelet (aspirin plus cilostazol) dual therapy for patients with noncardioembolic stroke within 48 hours of symptom onset. Methods and Results The ADS (Acute Aspirin Plus Cilostazol Dual Therapy for Non-Cardiogenic Stroke Patients Within 48 Hours of Symptom Onset ) study is an investigator-initiated, prospective, multicenter (34 hospitals in Japan), randomized, open-label, and aspirin-controlled trial. Acute stroke patients with noncardioembolic stroke within 48 hours of onset were studied. The subjects were randomly allocated to combination therapy with aspirin 81 to 200 mg plus cilostazol 200 mg (dual group) and single therapy with aspirin 81 to 200 mg (aspirin group) for 14 days. After the 14 days, all patients took the cilostazol 200 mg for 3 months. A primary efficacy outcome was defined as any one of the following occurring (neurological deterioration, symptomatic stroke recurrence, or transient ischemic attack) within 14 days. A primary safety outcome included intracerebral hemorrhage and subarachnoid hemorrhage. Between May 2011 and June 2017, 1201 patients (796 [66%] men; median age, 69 [61-77] years) randomized 1:1 to either the dual group or the aspirin group were analyzed. Initial National Institutes of Health Stroke Scale score was 2 (1-4) in both groups (P=0.830). A primary efficacy outcome was observed in 11% in the dual group and 11% in the aspirin group (P=0.853). A primary safety outcome occurred in 2 (0.3%) in the dual group and in 1 (0.2%) in the aspirin group (P=0.624). Conclusions Dual antiplatelet therapy using cilostazol and aspirin was safe but did not reduce the rate of short-term neurological worsening. Clinical Trial Registration URL: umin.ac.jp/ctr/index/htm. Unique identifier: UMIN000004950.",2019,Initial National Institutes of Health Stroke Scale score was 2 (1-4) in both groups (P=0.830).,"['Non-Cardiogenic Stroke Patients', 'Noncardioembolic Stroke Patients', 'patients with noncardioembolic stroke within 48\xa0hours of symptom onset', 'Acute stroke patients with noncardioembolic stroke within 48\xa0hours of onset were studied', 'Between May 2011 and June 2017, 1201 patients (796 [66%] men; median age, 69 [61-77] years']","['aspirin', 'ADS ', 'aspirin 81 to 200\xa0mg plus cilostazol 200\xa0mg (dual group) and single therapy with aspirin 81 to 200\xa0mg (aspirin', 'cilostazol and aspirin', 'antiplatelet (aspirin plus cilostazol) dual therapy', 'Acute Aspirin Plus Cilostazol Dual Therapy']","['Health Stroke Scale score', 'rate of short-term neurological worsening', 'intracerebral hemorrhage and subarachnoid hemorrhage', 'efficacy and safety', 'one of the following occurring (neurological deterioration, symptomatic stroke recurrence, or transient ischemic attack']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0038525', 'cui_str': 'SAH (Subarachnoid Hemorrhage)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}]",1201.0,0.0939648,Initial National Institutes of Health Stroke Scale score was 2 (1-4) in both groups (P=0.830).,"[{'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Aoki', 'Affiliation': 'Department of Neurological Science Graduate School of Medicine Nippon Medical School Tokyo Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Iguchi', 'Affiliation': 'Department of Neurology Jikei University School of Medicine Tokyo Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Urabe', 'Affiliation': 'Department of Neurology Juntendo University Urayasu Hospital Chiba Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamagami', 'Affiliation': 'Department of Neurology, Stroke Center Kobe City Medical Center General Hospital Hyogo Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Todo', 'Affiliation': 'Department of Neurology, Stroke Center Kobe City Medical Center General Hospital Hyogo Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Cerebrovascular Medicine, Stroke Center Steel Memorial Yawata Hospital Fukuoka Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Idomari', 'Affiliation': 'Department of Stroke Medicine Okinawa Kyodo Hospital Okinawa Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Kaneko', 'Affiliation': 'Department of Stroke Medicine Okinawa Kyodo Hospital Okinawa Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Iwanaga', 'Affiliation': 'Department of Stroke Medicine Okayama Red Cross Hospital Okayama Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Terasaki', 'Affiliation': 'Department of Neurology Japanese Red Cross Kumamoto Hospital Kumamoto Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Department of Neurology Faculty of Medicine Juntendo University Tokyo Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Clinical Neurosciences Institute of Biomedical Sciences Tokushima University Tokushima Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsujino', 'Affiliation': 'Department of Neurology and Strokology Nagasaki University Hospital Nagasaki Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Department of Neurology Shioda Hospital Chiba Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Department of Neurology Okayama University Medical School Okayama Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Uno', 'Affiliation': 'Department of Neurosurgery Kawasaki Medical School Okayama Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Department of Cerebrovascular Medicine and Neurology Clinical Research Institute National Hospital Organization Kyushu Medical Center Fukuoka Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Cerebrovascular Medicine NHO Kagoshima Medical Center Kagoshima Japan.'}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'Yamagata', 'Affiliation': 'Department of Neurosurgery Kurashiki Central Hospital Okayama Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Neurology Kyoto Second Red Cross Hospital Kyoto Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Yonehara', 'Affiliation': 'Department of Neurology Stroke Center Saiseikai Kumamoto Hospital Kumamoto Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Stroke Medicine Kawasaki Medical School General Medical Center Kawasaki Medical School Okayama Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Yagita', 'Affiliation': 'Department of Stroke Medicine Kawasaki Medical School Okayama Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Neurological Science Graduate School of Medicine Nippon Medical School Tokyo Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.119.012652']
493,31319747,Is It Safe for Patients With Cardiac Channelopathies to Undergo Routine Dental Care? Experience From a Single-Center Study.,"Background Brugada syndrome and long-QT syndrome may account for at least one third of unexplained sudden cardiac deaths. Dental care in patients with cardiac channelopathies is challenging because of the potential risk of life-threatening events. We hypothesized that the use of local dental anesthesia with lidocaine with and without epinephrine is safe and does not result in life-threatening arrhythmias in patients with channelopathies. Methods and Results We performed a randomized, double-blind pilot trial comparing the use of 2% lidocaine without a vasoconstrictor and with 1:100 000 epinephrine in 2 sessions of restorative dental treatment with a washout period of 7 days (crossover trial). Twenty-eight-hour Holter monitoring was performed, and 12-lead electrocardiography, digital sphygmomanometry, and anxiety scale assessments were also conducted at 3 time points. Fifty-six dental procedures were performed in 28 patients (18 women, 10 men) with cardiac channelopathies: 16 (57.1%) had long-QT syndrome, and 12 (42.9%) had Brugada syndrome; 11 (39.3%) of patients had an implantable defibrillator. The mean age was 45.9±15.9 years. The maximum heart rate increased after the use of epinephrine during the anesthesia period from 82.1 to 85.8 beats per minute (P=0.008). In patients with long-QT syndrome, the median corrected QT was higher, from 450.1 to 465.4 ms (P=0.009) at the end of anesthesia in patients in whom epinephrine was used. The other measurements showed no statistically significant differences. No life-threatening arrhythmias occurred during dental treatment. Conclusions The use of local dental anesthesia with lidocaine, regardless of the use of a vasoconstrictor, did not result in life-threatening arrhythmias and appears to be safe in stable patients with cardiac channelopathies. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03182777.",2019,No life-threatening arrhythmias occurred during dental treatment.,"['Patients', 'patients with channelopathies', '28 patients (18 women, 10 men) with cardiac channelopathies: 16 (57.1%) had long-QT syndrome, and 12 (42.9%) had Brugada syndrome; 11 (39.3%) of patients had an implantable defibrillator', 'stable patients with cardiac channelopathies', 'patients with cardiac channelopathies']","['vasoconstrictor and with 1:100\xa0000 epinephrine', 'lidocaine', 'epinephrine']","['No life-threatening arrhythmias', 'maximum heart rate', '12-lead electrocardiography, digital sphygmomanometry, and anxiety scale assessments', 'median corrected QT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1720983', 'cui_str': 'Channelopathies'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0023976', 'cui_str': 'Long QT Syndrome'}, {'cui': 'C4517773', 'cui_str': 'Forty-two point nine'}, {'cui': 'C1142166', 'cui_str': 'Sudden Unexplained Death Syndrome'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0042397', 'cui_str': 'Vasoactive Agonists'}, {'cui': 'C0456972', 'cui_str': '100 International Units in 0.1mL (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",,0.176868,No life-threatening arrhythmias occurred during dental treatment.,"[{'ForeName': 'Ana Carolina Guimarães', 'Initials': 'ACG', 'LastName': 'Oliveira', 'Affiliation': 'Unidade de Odontologia Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Itamara Lucia Itagiba', 'Initials': 'ILI', 'LastName': 'Neves', 'Affiliation': 'Unidade de Odontologia Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Sacilotto', 'Affiliation': 'Nucleo Clinico-Cirurgico de Arritmias Cardiacas Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Natália Quintella Sangiorgi', 'Initials': 'NQS', 'LastName': 'Olivetti', 'Affiliation': 'Nucleo Clinico-Cirurgico de Arritmias Cardiacas Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Marcela Alves Dos', 'Initials': 'MAD', 'LastName': 'Santos-Paul', 'Affiliation': 'Unidade de Odontologia Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Tânia Cristina Pedroso', 'Initials': 'TCP', 'LastName': 'Montano', 'Affiliation': 'Unidade de Odontologia Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Cíntia Maria Alencar', 'Initials': 'CMA', 'LastName': 'Carvalho', 'Affiliation': 'Unidade de Odontologia Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Tan Chen', 'Initials': 'TC', 'LastName': 'Wu', 'Affiliation': 'Nucleo Clinico-Cirurgico de Arritmias Cardiacas Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Cesar José', 'Initials': 'CJ', 'LastName': 'Grupi', 'Affiliation': 'Unidade de Eletrocardiografia Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Sílvio Alves', 'Initials': 'SA', 'LastName': 'Barbosa', 'Affiliation': 'Unidade de Eletrocardiografia Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Carlos Alberto', 'Initials': 'CA', 'LastName': 'Pastore', 'Affiliation': 'Unidade de Eletrocardiografia Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Samesima', 'Affiliation': 'Unidade de Eletrocardiografia Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Denise Tessariol', 'Initials': 'DT', 'LastName': 'Hachul', 'Affiliation': 'Nucleo Clinico-Cirurgico de Arritmias Cardiacas Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Maurício Ibrahim', 'Initials': 'MI', 'LastName': 'Scanavacca', 'Affiliation': 'Nucleo Clinico-Cirurgico de Arritmias Cardiacas Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Ricardo Simões', 'Initials': 'RS', 'LastName': 'Neves', 'Affiliation': 'Unidade de Odontologia Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}, {'ForeName': 'Francisco Carlos Costa', 'Initials': 'FCC', 'LastName': 'Darrieux', 'Affiliation': 'Nucleo Clinico-Cirurgico de Arritmias Cardiacas Instituto do Coracao Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo Brazil.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.012361']
494,31331219,Prospective Randomized Comparison of Fractional Flow Reserve Versus Optical Coherence Tomography to Guide Revascularization of Intermediate Coronary Stenoses: One-Month Results.,"Background Fractional flow reserve (FFR) and optical coherence tomography (OCT) may help both in assessment and in percutaneous coronary intervention optimization of angiographically intermediate coronary lesions. We designed a prospective trial comparing the clinical and economic outcomes associated with FFR or OCT in angiographically intermediate coronary lesions. Methods and Results Three hundred fifty patients with angiographically intermediate coronary lesions (n=446) were randomized to FFR or OCT guidance. In the FFR arm, percutaneous coronary intervention was performed if FFR was ≤0.80 aiming for a postprocedure FFR >0.90. In the OCT arm, percutaneous coronary intervention was performed if percentage of area stenosis was ≥75% or 50% to 75% with minimal lumen area <2.5 mm 2  or plaque ulceration. Costs, angina frequency, and major adverse cardiac events were assessed at 1 month and at 13 months. We present early data at 1 month consistent with a prespecified analysis of secondary end points. Patients randomized to FFR, as compared with OCT, were significantly more commonly managed with medical therapy alone (67.7% versus 41.1%; P<0.001), required less contrast media (245±137 versus 280±129 mL; P=0.004), and exhibited a lower occurrence of contrast-induced acute kidney injury (1.7% versus 8.6%; P=0.034). At 1 month, in comparison to FFR, OCT was associated with increased total costs (2831±1288 versus 4292±3844 euros/patient; P<0.001) whereas occurrence of major adverse cardiac events or significant angina was similar. Conclusions In patients with angiographically intermediate coronary lesions, a functional guidance by FFR, as compared with OCT, increased the rate of patients treated with medical therapy alone. This translated into a significant reduction in administered contrast, contrast-induced acute kidney injury, and total costs at 1 month with FFR. Clinical Trial Registration URL: http://www.clinicaltrialsgov. Unique identifier: NCT01824030.",2019,"This translated into a significant reduction in administered contrast, contrast-induced acute kidney injury, and total costs at 1 month with FFR.","['Three hundred fifty patients with angiographically intermediate coronary lesions (n=446', 'patients with angiographically intermediate coronary lesions', 'angiographically intermediate coronary lesions', 'Intermediate Coronary Stenoses']","['percutaneous coronary intervention', 'FFR', 'FFR or OCT guidance', 'FFR or OCT', 'Fractional Flow Reserve Versus Optical Coherence Tomography', ' Fractional flow reserve (FFR) and optical coherence tomography (OCT']","['occurrence of major adverse cardiac events', 'Costs, angina frequency, and major adverse cardiac events', 'total costs', 'acute kidney injury', 'percentage of area stenosis']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0242231', 'cui_str': 'Coronary Artery Stenosis'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}]",350.0,0.0244852,"This translated into a significant reduction in administered contrast, contrast-induced acute kidney injury, and total costs at 1 month with FFR.","[{'ForeName': 'Antonio Maria', 'Initials': 'AM', 'LastName': 'Leone', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Burzotta', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Aurigemma', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy.'}, {'ForeName': 'Giovanni Luigi', 'Initials': 'GL', 'LastName': 'De Maria', 'Affiliation': 'Department of Cardiology John Radcliffe Hospital Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom.'}, {'ForeName': 'Aniello', 'Initials': 'A', 'LastName': 'Zambrano', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Zimbardo', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy.'}, {'ForeName': 'Manfredi', 'Initials': 'M', 'LastName': 'Arioti', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Cerracchio', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Vergallo', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Trani', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Crea', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.012772']
495,30602756,Influence of peripheral corneal relaxing incisions during cataract surgery for corneal astigmatism up to 2.5 dioptres on corneal densitometry.,"PURPOSE


To assess the effect of peripheral corneal relaxing incisions (PCRI) for astigmatism between 0.75 and 2.5 dioptres during cataract surgery on corneal densitometry (CD).
METHODS


In this prospective, randomised study, 80 eyes (80 patients), received either tIOL or PCRI. Assessment at pre-operative and 1, 3, 6, 12 months post-operative visit included uncorrected (UCDVA) and best-corrected distance visual acuity (BCDVA), spherical equivalent (SEQ) (only post-operatively), mean anterior and posterior keratometric astigmatism (K A ) and CD with Schiempflug system. CD was analysed in four concentric radial zones from centre to periphery (Zone 1 to 4) and in 3 layers (anterior, mid-stromal and posterior).
RESULTS


Comparing tIOLs vs. PCRIs, there was no significant difference in the UCDVA, BCDVA and SEQ. In PCRI group, anterior K A  decreased at 1 month and remained stable thereafter. For zones 1, 2 and 3, CD significantly reduced after 3 months with tIOLs whereas with PCRIs, it reduced 1 month onwards. For zone 4, CD reduced only at 12 months with tIOLs compared to 3 months onwards with PCRIs. In both groups CD was higher in the zone 4 and anterior layer. Significant reduction in CD was found in all three layers of cornea after 3 months in tIOL and after first month in PCRI groups, respectively.
CONCLUSIONS


Cataract surgery alone reduces the CD. Reducing keratometric astigmatism with PCRIs shows significant differences in CD from early post-operative period for central and anterior corneal layer.",2019,"Significant reduction in CD was found in all three layers of cornea after 3 months in tIOL and after first month in PCRI groups, respectively.
",['80 eyes (80 patients'],"['peripheral corneal relaxing incisions', 'tIOL or PCRI', 'peripheral corneal relaxing incisions (PCRI']","['corneal densitometry (CD', 'CD', 'anterior K A', 'uncorrected (UCDVA) and best-corrected distance visual acuity (BCDVA), spherical equivalent (SEQ) (only post-operatively), mean anterior and posterior keratometric astigmatism (K A ) and CD with Schiempflug system', 'UCDVA, BCDVA and SEQ']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1275660', 'cui_str': 'LRI - limbal relaxing incision'}]","[{'cui': 'C0011321', 'cui_str': 'Densitometry'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",80.0,0.0194215,"Significant reduction in CD was found in all three layers of cornea after 3 months in tIOL and after first month in PCRI groups, respectively.
","[{'ForeName': 'Ieva', 'Initials': 'I', 'LastName': 'Zukaite', 'Affiliation': 'Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton, BN2 5BF, UK.'}, {'ForeName': 'Kaveeta K', 'Initials': 'KK', 'LastName': 'Bedi', 'Affiliation': 'Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton, BN2 5BF, UK.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9PX, UK.'}, {'ForeName': 'Mayank A', 'Initials': 'MA', 'LastName': 'Nanavaty', 'Affiliation': 'Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton, BN2 5BF, UK. mayank.nanavaty@bsuh.nhs.uk.'}]","Eye (London, England)",['10.1038/s41433-018-0327-5']
496,31345083,Safety of Amlodipine in Early Pregnancy.,"Background Amlodipine is used for the treatment of hypertension, but reports on its use in early pregnancy are limited. Methods and Results In the present study, we recruited 231 women with chronic hypertension, including those who received amlodipine or other antihypertensives during early pregnancy, and investigated frequencies of morphologic abnormalities in their 231 offspring. Specifically, we evaluated 48 neonates exposed to amlodipine in the first trimester (amlodipine group, Group A), 54 neonates exposed to antihypertensives other than amlodipine (other antihypertensive group, Group O), and 129 neonates not exposed to antihypertensives (no-antihypertensive group, Group N). The number of morphologic abnormalities of offspring in each group were 2 in Group A (4.2%; 95% CI, 0.51-14.25); 3 in Group O (5.6%; 95% CI, 1.16-15.39) and 6 in Group N (4.7%; 95% CI, 1.73-9.85). The odds ratio of the primary outcome comparing Group A and Group O was 0.74 (95% CI: 0.118-4.621) and Group A and Group N was 0.89 (95% CI: 0.174-4.575). Conclusions The odds of birth defects in Group A in the first trimester were not significantly different from those with or without other antihypertensives.",2019,The odds of birth defects in Group A in the first trimester were not significantly different from those with or without other antihypertensives.,"['48 neonates exposed to', 'Early Pregnancy', 'or other antihypertensives during early pregnancy, and investigated frequencies of morphologic abnormalities in their 231 offspring', '231 women with chronic hypertension, including those who received']","['129 neonates not exposed to antihypertensives (no-antihypertensive', 'amlodipine', 'Amlodipine', '54 neonates exposed to antihypertensives other than amlodipine', ' Amlodipine']","['odds of birth defects', 'number of morphologic abnormalities']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C3539170', 'cui_str': 'OTHER ANTIHYPERTENSIVES in ATC'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",231.0,0.106359,The odds of birth defects in Group A in the first trimester were not significantly different from those with or without other antihypertensives.,"[{'ForeName': 'Asako', 'Initials': 'A', 'LastName': 'Mito', 'Affiliation': 'Drug Information Institute in Pregnancy Tokyo Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Murashima', 'Affiliation': 'Drug Information Institute in Pregnancy Tokyo Japan.'}, {'ForeName': 'Yoshinao', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': ""Department of Obstetric Medicine Osaka Women's and Children's Hospital Osaka Japan.""}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Miyasato-Isoda', 'Affiliation': 'Department of Internal Medicine (I) Osaka Medical College Osaka Japan.'}, {'ForeName': 'Chizuko A', 'Initials': 'CA', 'LastName': 'Kamiya', 'Affiliation': 'Department of Perinatology and Gynecology National Cerebral and Cardiovascular Center Osaka Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Waguri', 'Affiliation': ""Department of Obstetric Medicine Osaka Women's and Children's Hospital Osaka Japan.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yoshimatsu', 'Affiliation': 'Department of Perinatology and Gynecology National Cerebral and Cardiovascular Center Osaka Japan.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Yakuwa', 'Affiliation': 'Drug Information Institute in Pregnancy Tokyo Japan.'}, {'ForeName': 'Omi', 'Initials': 'O', 'LastName': 'Watanabe', 'Affiliation': 'Drug Information Institute in Pregnancy Tokyo Japan.'}, {'ForeName': 'Tomo', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Drug Information Institute in Pregnancy Tokyo Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Arata', 'Affiliation': 'Drug Information Institute in Pregnancy Tokyo Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Mikami', 'Affiliation': 'Division of Biostatistics Clinical Research Center National Center for Child Health and Development Tokyo Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Motherisk Program Division of Clinical Pharmacology and Toxicology Department of Paediatrics The Hospital for Sick Children University of Toronto Toronto Canada.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.012093']
497,32273271,A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial.,"OBJECTIVE


The role of U300 glargine insulin for the inpatient management of type 2 diabetes (T2D) has not been determined. We compared the safety and efficacy of glargine U300 versus glargine U100 in noncritically ill patients with T2D.
RESEARCH DESIGN AND METHODS


This prospective, open-label, randomized clinical trial included 176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA 1c  9.5 ± 2.2%), treated with oral agents or insulin before admission. Patients were treated with a basal-bolus regimen with glargine U300 ( n  = 92) or glargine U100 ( n  = 84) and glulisine before meals. We adjusted insulin daily to a target BG of 70-180 mg/dL. The primary end point was noninferiority in the mean difference in daily BG between groups. The major safety outcome was the occurrence of hypoglycemia.
RESULTS


There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL,  P  = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%,  P  = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days,  P  = 0.06), hospital complications (6.5% vs. 11%,  P  = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day,  P  = 0.74). There were no differences in the proportion of patients with BG <70 mg/dL (8.7% vs. 9.5%,  P  > 0.99), but glargine U300 resulted in significantly lower rates of clinically significant hypoglycemia (<54 mg/dL) compared with glargine U100 (0% vs. 6.0%,  P  = 0.023).
CONCLUSIONS


Hospital treatment with glargine U300 resulted in similar glycemic control compared with glargine U100 and may be associated with a lower incidence of clinically significant hypoglycemia.",2020,"There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL,  P  = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%,  P  = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days,  P  = 0.06), hospital complications (6.5% vs. 11%,  P  = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day,  P  = 0.74).","['type 2 diabetes (T2D', 'Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial', '176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA 1c  9.5 ± 2.2%), treated with oral agents or insulin before admission', 'noncritically ill patients with T2D.\nMETHODS']","['Glargine U300 and Glargine U100', 'U300 glargine insulin', 'glargine U300 versus glargine', 'glargine U100', 'glargine U300']","['percentage of readings within target BG', 'safety and efficacy', 'rates of clinically significant hypoglycemia', 'length of stay', 'hospital complications', 'occurrence of hypoglycemia']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",176.0,0.187812,"There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL,  P  = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%,  P  = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days,  P  = 0.06), hospital complications (6.5% vs. 11%,  P  = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day,  P  = 0.74).","[{'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'M Cecilia', 'Initials': 'MC', 'LastName': 'Lansang', 'Affiliation': 'The Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Ameer', 'Initials': 'A', 'LastName': 'Khowaja', 'Affiliation': 'Hennepin County Medical Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'M Agustina', 'Initials': 'MA', 'LastName': 'Urrutia', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Albury', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Rodolfo J', 'Initials': 'RJ', 'LastName': 'Galindo', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Migdal', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA geumpie@emory.edu.'}]",Diabetes care,['10.2337/dc19-1940']
498,31129681,Maternal anemia type during pregnancy is associated with anemia risk among offspring during infancy.,"BACKGROUND


We evaluated the association between etiology of maternal anemia and iron status throughout infancy.
METHODS


Samples from a study designed to examine Praziquantel treatment during pregnancy were used (n = 359). All women were infected with schistosomiasis and randomized to Praziquantel or placebo at 16 ± 2 weeks' gestation. Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood. The relationship between both maternal Praziquantel treatment and etiology of anemia and infant iron status was evaluated.
RESULTS


Maternal iron-deficiency anemia was associated with increased risk of infant anemia at 6 months of age. Infants of mothers with the lowest levels of circulating hepcidin during gestation, likely a marker for iron deficiency, had higher sTfR:SF levels and lower hemoglobin levels, particularly at 12 months of age. Maternal non-iron-deficiency anemia (NIDA) did not impact infant anemia risk or iron status. Maternal treatment for schistosomiasis had no effect on infant hematologic status.
CONCLUSIONS


Maternal iron deficiency anemia was associated with an increased risk for anemia or iron deficiency during late infancy. We did not observe an association between maternal NIDA and increased risk for iron deficiency during infancy.",2019,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.",['All women were infected with schistosomiasis and randomized to'],"['Praziquantel or placebo', 'Praziquantel']","['sTfR', 'SF levels and lower hemoglobin levels', 'risk of infant anemia', 'Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6', 'Maternal anemia type', 'etiology of anemia and infant iron status', 'Maternal iron-deficiency anemia', 'Maternal non-iron-deficiency anemia (NIDA']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036323', 'cui_str': 'Schistoma Infection'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble (substance)'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0068218', 'cui_str': 'NIDA'}]",,0.133641,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.","[{'ForeName': 'Ajibola I', 'Initials': 'AI', 'LastName': 'Abioye', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'McDonald', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sangshin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA. spark@uos.ac.kr.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ripp', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Brady', 'Initials': 'B', 'LastName': 'Bennett', 'Affiliation': 'Center for International Health Research, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Hannah W', 'Initials': 'HW', 'LastName': 'Wu', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sunthorn', 'Initials': 'S', 'LastName': 'Pond-Tor', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Marianne J', 'Initials': 'MJ', 'LastName': 'Sagliba', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Amabelle J', 'Initials': 'AJ', 'LastName': 'Amoylen', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Palmera I', 'Initials': 'PI', 'LastName': 'Baltazar', 'Affiliation': 'Remedios Trinidad Romualdez Hospital, Tacloban City, Leyte, The Philippines.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tallo', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Luz P', 'Initials': 'LP', 'LastName': 'Acosta', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Remigio M', 'Initials': 'RM', 'LastName': 'Olveda', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Kurtis', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Friedman', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Pediatric research,['10.1038/s41390-019-0433-5']
499,31048509,Multidisciplinary home-based rehabilitation in inoperable lung cancer: a randomised controlled trial.,"BACKGROUND


Lung cancer is associated with poor health-related quality of life (HRQoL) and high symptom burden. This trial aimed to assess the efficacy of home-based rehabilitation versus usual care in inoperable lung cancer.
METHODS


A parallel-group, assessor-blinded, allocation-concealed, randomised controlled trial. Eligible participants were allocated (1:1) to usual care (UC) plus 8 weeks of aerobic and resistance exercise with behaviour change strategies and symptom support (intervention group (IG)) or UC alone. Assessments occurred at baseline, 9 weeks and 6 months. The primary outcome, change in between-group 6 min walk distance (6MWD), was analysed using intention-to-treat (ITT). Subsequent analyses involved modified ITT (mITT) and included participants with at least one follow-up outcome measure. Secondary outcomes included HRQoL and symptoms.
RESULTS


Ninety-two participants were recruited. Characteristics of participants (UC=47, IG=45): mean (SD) age 64 (12) years; men 55%; disease stage n (%) III=35 (38) and IV=48 (52); radical treatment 46%. There were no significant between-group differences for the 6MWD (n=92) at 9 weeks (p=0.308) or 6 months (p=0.979). The mITT analyses of 6MWD between-group differences were again non-significant (mean difference (95% CI): 9 weeks: -25.4 m (-64.0 to 13.3), p=0.198 and 6 months: 41.3 m (-26.7 to 109.4), p=0.232). Significant 6-month differences, favouring the IG, were found for HRQoL (Functional Assessment of Cancer Therapy-Lung: 13.0 (3.9 to 22.1), p=0.005) and symptom severity (MD Anderson Symptom Inventory-Lung Cancer: -2.2 (-3.6 to -0.9), p=0.001).
CONCLUSIONS


Home-based rehabilitation did not improve functional exercise capacity but there were improvements in patient-reported exploratory secondary outcomes measures observed at 6 months.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12614001268639).",2019,"Significant 6-month differences, favouring the IG, were found for HRQoL (Functional Assessment of Cancer Therapy-Lung: 13.0 (3.9 to 22.1), p=0.005) and symptom severity (MD Anderson Symptom Inventory-Lung Cancer: -2.2 (-3.6 to -0.9), p=0.001).
","['Characteristics of participants (UC=47, IG=45): mean (SD) age 64 (12) years; men 55%; disease stage n (%) III=35 (38) and IV=48 (52); radical treatment 46', 'Ninety-two participants were recruited', 'inoperable lung cancer']","['home-based rehabilitation versus usual care', '6MWD', 'usual care (UC) plus 8 weeks of aerobic and resistance exercise with behaviour change strategies and symptom support (intervention group (IG)) or UC alone', 'Multidisciplinary home-based rehabilitation']","['HRQoL (Functional Assessment of Cancer Therapy-Lung', 'functional exercise capacity', 'symptom severity (MD Anderson Symptom Inventory-Lung Cancer', 'intention-to-treat (ITT', 'HRQoL and symptoms', 'change in between-group 6 min walk distance (6MWD']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",92.0,0.218499,"Significant 6-month differences, favouring the IG, were found for HRQoL (Functional Assessment of Cancer Therapy-Lung: 13.0 (3.9 to 22.1), p=0.005) and symptom severity (MD Anderson Symptom Inventory-Lung Cancer: -2.2 (-3.6 to -0.9), p=0.001).
","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Edbrooke', 'Affiliation': 'Department of Physiotherapy, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Sanchia', 'Initials': 'S', 'LastName': 'Aranda', 'Affiliation': 'Cancer Council Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Granger', 'Affiliation': 'Department of Physiotherapy, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'McDonald', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Institute for Breathing and Sleep, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Krishnasamy', 'Affiliation': 'Department of Nursing and Centre for Cancer Research, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mileshkin', 'Affiliation': 'Department of Medical Oncology, The Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Clark', 'Affiliation': 'University of the Sunshine Coast, Sippy Downs, Queensland, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gordon', 'Affiliation': 'Statistical Consulting Centre, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Irving', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Denehy', 'Affiliation': 'Allied Health Service, The Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia l.denehy@unimelb.edu.au.'}]",Thorax,['10.1136/thoraxjnl-2018-212996']
500,32301137,Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data.,"BACKGROUND


Relamorelin, a pentapeptide ghrelin receptor agonist, accelerated gastric emptying significantly and improved symptoms in adults with diabetic gastroparesis in phase 2 trials.
AIM


To assess the safety and tolerability of relamorelin across phase 2 trials.
METHODS


Safety assessments in patients aged 18-75 years (weight, adverse events [AEs] and laboratory tests) from two randomised, double-blind phase 2 trials (NCT01571297, NCT02357420; results published previously) were reviewed descriptively. Analysis of covariance assessed treatment effect on glycated haemoglobin (HbA1c) and blood glucose post hoc. Phase 2a and 2b trial durations were, respectively, 4 weeks (relamorelin 10 µg once or twice daily [b.d.] or placebo b.d.) and 12 weeks (relamorelin 10, 30 or 100 µg or placebo b.d.) with 1- and 2-week, single-blind placebo run-ins.
RESULTS


Among 204 phase 2a and 393 phase 2b patients, respectively, 67% and 62% were female, and 88% and 89% had type 2 diabetes. Proportions of patients reporting serious AEs were similar across treatment groups, as were those with ≥1 treatment-emergent AE (TEAE). TEAE-related discontinuations were proportionally higher in relamorelin groups than placebo. Of 12 serious TEAEs in phase 2a, none occurred in >1 patient. In phase 2b, five serious TEAEs were reported in >1 patient, and one (100 µg) died (urosepsis), all unrelated to relamorelin. In phase 2b, increased HbA1c and fasting blood glucose levels were dose-related (P < 0.0001 and P = 0.0043, respectively).
CONCLUSIONS


Relamorelin showed acceptable safety and tolerability in phase 2 trials. Relamorelin may elevate blood glucose: this should be managed proactively in relamorelin-treated patients.",2020,"In phase 2b, increased HbA1c and fasting blood glucose levels were dose-related (P < 0.0001 and P = 0.0043, respectively).
","['adults with diabetic gastroparesis', '204 phase 2a and 393 phase 2b patients, respectively, 67% and 62% were female, and 88% and 89% had type 2 diabetes', 'adults with diabetic gastroparesis in phase\xa02 trials', 'patients aged 18-75\xa0years (weight, adverse events [AEs] and laboratory tests']","['Relamorelin', 'placebo', 'relamorelin', 'placebo b.d.) and 12\xa0weeks (relamorelin 10, 30 or 100\xa0µg or placebo b.d.) with 1- and 2-week, single-blind placebo run-ins']","['Overall safety', 'glycated haemoglobin (HbA1c) and blood glucose post hoc', 'TEAE-related discontinuations', 'blood glucose', 'safety and tolerability', 'acceptable safety and tolerability', 'HbA1c and fasting blood glucose levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0267176', 'cui_str': 'Gastroparesis with diabetes mellitus'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]","[{'cui': 'C4045486', 'cui_str': 'relamorelin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",,0.432022,"In phase 2b, increased HbA1c and fasting blood glucose levels were dose-related (P < 0.0001 and P = 0.0043, respectively).
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lembo', 'Affiliation': 'Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McCallum', 'Affiliation': 'Division of Gastroenterology, Texas Tech University Health Sciences Center, El Paso, TX, USA.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Tourkodimitris', 'Affiliation': 'Biostatistics, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Kemps', 'Affiliation': 'Clinical Development, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Miller', 'Affiliation': 'Chemistry, Manufacturing and Controls, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Bertelsen', 'Affiliation': 'Clinical Pharmacology, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Iacob', 'Affiliation': 'Medical Safety, Allergan plc, Madison, NJ, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15711']
501,32301388,Comparison of the effects of intravenous propofol and propofol with low-dose ketamine on preventing postextubation cough and laryngospasm among patients awakening from general anaesthesia: A prospective randomised clinical trial.,"BACKGROUND


Coughing and laryngospasm are undesirable consequences occurring when patients awaken from general anaesthesia. The objective of the study aimed to compare the effects of intravenous propofol and propofol with low-dose ketamine on preventing postextubation cough and laryngospasm.
METHODS


In all, 120 patients scheduled surgery under general anaesthesia were randomly assigned into three groups. Patients in the control group (C-group) obtained intravenous 0.9% NaCl, while patients in the propofol group (P-group) obtained intravenous 0.25mg/kg propofol and patients in the propofol combined with ketamine group (PK-group) obtained intravenous 0.25mg/kg of propofol plus 0.15mg/kg of ketamine. Drugs were administered before extubation. Incidence and severity of coughing and laryngospasm were recorded by a blinded anaesthesiologist.
RESULTS


Subjects of the PK-group (25%) experienced significantly reduced incidence of postoperative cough than that in the P-group (55%) and C-group (72.5%) (all P < 0.05). The severity of cough in the PK-group was significantly less than that in the P-group and C-group (P = 0.039 and P < 0.001, respectively). No significant difference was found in the incidence and severity of laryngospasm between comparison groups.
CONCLUSION


Intravenous combination of propofol and low-dose ketamine significantly reduced the incidence and severity among patients awakening from general anaesthesia.",2020,,['patients awakening from general anaesthesia'],['propofol and propofol with low-dose ketamine'],['postextubation cough and laryngospasm'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0023066', 'cui_str': 'Laryngeal spasm'}]",,0.0201312,,"[{'ForeName': 'Yanipan', 'Initials': 'Y', 'LastName': 'Chungsamarnyart', 'Affiliation': 'Department of Anesthesiology, Phramongkutklao Hospital and Phramongkutklao Collage of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Jiranun', 'Initials': 'J', 'LastName': 'Pairart', 'Affiliation': 'Department of Anesthesiology, Phramongkutklao Hospital and Phramongkutklao Collage of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Sithapan', 'Initials': 'S', 'LastName': 'Munjupong', 'Affiliation': 'Department of Anesthesiology, Phramongkutklao Hospital and Phramongkutklao Collage of Medicine, Bangkok, Thailand.'}]",Journal of perioperative practice,['10.1177/1750458920912636']
502,32301681,Changes in countermovement jump performance and subjective readiness-to-train scores following a simulated soccer match.,"The study investigated whether countermovement jump (CMJ) metrics and subjective responses to a readiness-to-train questionnaire (RTT-Q) tracked simulated match-induced acute fatigue. This was a randomized cross-over repeated measures study. Participants were assigned into one of two groups; CONTROL or LIST. The LIST group performed the Loughborough Intermittent Shuttle Run (LIST), which was designed to simulate the demands of a soccer match. The CONTROL performed light physical activity at an intensity of <65% of maximal heart rate. Each group performed three CMJ's and completed an RTT-Q before (PRE), and again at 24 and 48 h after the LIST and/or CONTROL interventions. At 24 h there were significant differences in RTT-Q answers between the Pre and 24 h for the LIST group for questions; ""Do you feel physically strong today?"" and ""Do you have muscle soreness today?"" ( p  = 0.02 and 0.0008, respectively). The questions ""Do you feel mentally strong today?"" and "" Do you have muscle soreness today ?"" ( p  = 0.02 and  p  = 0.0001 respectively) were the only questions that had a significant difference between Pre and 48 h for the LIST group. None of the CMJ metrics (LIST or CONTROL) changed significantly at any stage of the experiment. Although fatigue was detected by changes in the RTT-Q at 24 and 48 h after the LIST, none of the CMJ metrics changed. These findings suggest that subjective measures are more sensitive to low-level fatigue than objective measures, thus effective monitoring should include both.",2020,"At 24 h there were significant differences in RTT-Q answers between the Pre and 24 h for the LIST group for questions; "" Do you feel physically strong today ?"" and "" Do you have muscle soreness today ?""",[],"['countermovement jump (CMJ) metrics and subjective responses to a readiness-to-train questionnaire (RTT-Q', 'Loughborough Intermittent Shuttle Run (LIST', 'LIST']","['RTT-Q answers', 'countermovement jump performance and subjective readiness-to-train scores']",[],"[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.043078,"At 24 h there were significant differences in RTT-Q answers between the Pre and 24 h for the LIST group for questions; "" Do you feel physically strong today ?"" and "" Do you have muscle soreness today ?""","[{'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Lombard', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Starling', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wewege', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lambert', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}]",European journal of sport science,['10.1080/17461391.2020.1757764']
503,28851037,"The effects of a lipid-based nutrient supplement and antiretroviral therapy in a randomized controlled trial on iron, copper, and zinc in milk from HIV-infected Malawian mothers and associations with maternal and infant biomarkers.","We evaluated effects of antiretroviral (ARV) therapy and lipid-based nutrient supplements (LNSs) on iron, copper, and zinc in milk of exclusively breastfeeding HIV-infected Malawian mothers and their correlations with maternal and infant biomarkers. Human milk and blood at 2, 6, and 24 weeks post-partum and blood during pregnancy (≤30 weeks gestation) were collected from 535 mothers/infant-pairs in the Breastfeeding, Antiretrovirals, and Nutrition study. The participants received ARV, LNS, ARV and LNS, or no intervention from 0 to 28 weeks post-partum. ARVs negatively affected copper and zinc milk concentrations, but only at 2 weeks, whereas LNS had no effect. Among all treatment groups, approximately 80-90% of copper and zinc and <50% of iron concentrations met the current adequate intake for infants at 2 weeks and only 1-19% at 24 weeks. Pregnancy haemoglobin was negatively correlated with milk iron at 2 and 6 weeks (r = -.18, p < .02 for both). The associations of the milk minerals with each other were the strongest correlations observed (r = .11-.47, p < .05 for all); none were found with infant biomarkers. At 2 weeks, moderately anaemic women produced milk higher in iron when ferritin was higher or TfR lower. At 6 weeks, higher maternal α-1-acid glycoprotein and C-reactive protein were associated with higher milk minerals in mildly anaemic women. Infant TfR was lower when milk mineral concentrations were higher at 6 weeks and when mothers were moderately anaemic during pregnancy. ARV affects copper and zinc milk concentrations in early lactation, and maternal haemoglobin during pregnancy and lactation could influence the association between milk minerals and maternal and infant iron status and biomarkers of inflammation.",2018,"At 6 weeks, higher maternal α-1-acid glycoprotein and C-reactive protein were associated with higher milk minerals in mildly anaemic women.","['mildly anaemic women', 'milk from HIV-infected Malawian mothers and associations with maternal and infant biomarkers']","['ARV, LNS, ARV and LNS, or no intervention', 'antiretroviral (ARV) therapy and lipid-based nutrient supplements (LNSs', 'lipid-based nutrient supplement and antiretroviral therapy']","['iron, copper, and zinc in milk', 'ARV affects copper and zinc milk concentrations', 'copper and zinc milk concentrations', 'milk mineral concentrations', 'higher maternal α-1-acid glycoprotein and C-reactive protein', 'Pregnancy haemoglobin']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",535.0,0.108645,"At 6 weeks, higher maternal α-1-acid glycoprotein and C-reactive protein were associated with higher milk minerals in mildly anaemic women.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hampel', 'Affiliation': 'USDA, ARS Western Human Nutrition Research Center, Davis, California, USA.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Shahab-Ferdows', 'Affiliation': 'USDA, ARS Western Human Nutrition Research Center, Davis, California, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Gertz', 'Affiliation': 'USDA, ARS Western Human Nutrition Research Center, Davis, California, USA.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Flax', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Adair', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Bentley', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Denise J', 'Initials': 'DJ', 'LastName': 'Jamieson', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Tegha', 'Affiliation': 'UNC Project, Lilongwe, Malawi.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Chasela', 'Affiliation': 'UNC Project, Lilongwe, Malawi.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Kamwendo', 'Affiliation': 'UNC Project, Lilongwe, Malawi.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'van der Horst', 'Affiliation': 'School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Lindsay H', 'Initials': 'LH', 'LastName': 'Allen', 'Affiliation': 'USDA, ARS Western Human Nutrition Research Center, Davis, California, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12503']
504,32300910,A Randomized Controlled Trial of Functional Communication Training via Telehealth for Young Children with Autism Spectrum Disorder.,"Many children with autism spectrum disorder (ASD) have problem behaviors that interfere with learning and social interaction. This randomized controlled trial compared treatment with functional communication training (FCT) to ""treatment as usual"" for young children with ASD (n = 38, ages 21-84 months). FCT was conducted by parents with training and real-time coaching provided by behavioral consultants using telehealth. FCT treatment via telehealth achieved a mean reduction in problem behavior of 98% compared to limited behavioral improvement in children receiving ""treatment as usual"" during a 12-week period. Social communication and task completion also improved. For children with ASD and moderate to severe behavior problems, parent-implemented FCT using telehealth significantly reduced problem behavior while ongoing interventions typically did not.",2020,"FCT treatment via telehealth achieved a mean reduction in problem behavior of 98% compared to limited behavioral improvement in children receiving ""treatment as usual"" during a 12-week period.","['young children with ASD (n\u2009=\u200938, ages 21-84\xa0months', 'Young Children with Autism Spectrum Disorder', 'children with autism spectrum disorder (ASD']","['Functional Communication Training via Telehealth', 'FCT', 'functional communication training (FCT']",['Social communication and task completion'],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C4708134', 'cui_str': 'Functional communication training'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.0709193,"FCT treatment via telehealth achieved a mean reduction in problem behavior of 98% compared to limited behavioral improvement in children receiving ""treatment as usual"" during a 12-week period.","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Lindgren', 'Affiliation': 'Stead Family Department of Pediatrics, University of Iowa College of Medicine, 100 Hawkins Drive, Iowa City, IA, 52242, USA. scott-lindgren@uiowa.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wacker', 'Affiliation': 'Stead Family Department of Pediatrics, University of Iowa College of Medicine, 100 Hawkins Drive, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Schieltz', 'Affiliation': 'Stead Family Department of Pediatrics, University of Iowa College of Medicine, 100 Hawkins Drive, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Suess', 'Affiliation': 'Chatter Pediatric Therapy, Williston, ND, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Pelzel', 'Affiliation': 'Department of Psychiatry, University of Iowa College of Medicine, Iowa City, IA, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Kopelman', 'Affiliation': 'Department of Psychiatry, University of Iowa College of Medicine, Iowa City, IA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Telehealth Behavioral Consultation Services, Sahuarita, AZ, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Romani', 'Affiliation': ""Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO, USA.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': ""O'Brien"", 'Affiliation': 'Stead Family Department of Pediatrics, University of Iowa College of Medicine, 100 Hawkins Drive, Iowa City, IA, 52242, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04451-1']
505,32298143,Randomized Controlled Trial of a Novel Peer Concussion-Education Program for Collegiate Athletes.,"CONTEXT


The National Collegiate Athletic Association and US Department of Defense have called for educational programs to change the culture of concussion reporting, increase reporting behavior, and enhance the safety of players and service members.
OBJECTIVE


To evaluate the effects of a novel peer concussion-education program (PCEP) in changing knowledge, attitudes, and norms about concussion reporting among collegiate student-athletes and assess program implementation.
DESIGN


Randomized controlled trial and qualitative analysis of interviews.
SETTING


National Collegiate Athletic Association athletic teams from randomly selected colleges or universities.
PATIENTS OR OTHER PARTICIPANTS


A total of 1614 male and female student-athletes from 60 teams at 10 colleges and universities and 8 athletic trainers.
INTERVENTION(S)


The PCEP intervention trains 2 peer concussion educators to provide 2 education modules to their teammates. Knowledge, attitudes (oneself and teammates), and concussion occurrence or reporting were assessed at baseline, postintervention, and 1 month later. Eight athletic trainers were interviewed about program implementation.
RESULTS


Compared with the control group, the intervention group showed greater increases occurred postintervention and at 1 month in concussion knowledge ( F 1,2648  = 51.3,  P  < .0001), intention to report (oneself,  F 2,2633  = 82.3,  P  < .0001; teammates,  F 2,2624  = 53.9,  P  < .0001), return-to-play protocol knowledge, ( F 2,2632  = 28.4,  P  < .0001), direct subjective norms (oneself,  F 2,2625  = 51.7,  P  < .0001; teammates,  F 2,2644  = 40.6,  P  < .0001), direct perceived behavioral control (oneself,  F 2,2628  = 53.7,  P  < .0001; teammates,  F 2,2615  = 68.2,  P  < .0001), and indirect attitudes (oneself,  F 2,2626  = 47.1,  P  < .001; teammates,  F 2,2623  = 40.9,  P  < .0001). Peer concussion-education program participants discussed concussion more often with a teammate ( F 1,1396  = 13.96,  P  < .0001) or athletic staff ( F 1,1396  = 6.62,  P  < .001). Qualitative program analysis revealed both positive aspects of the PCEP and areas for improvement.
CONCLUSIONS


The PCEP showed promise in increasing concussion knowledge, intention to report concussion, reporting a teammate's concussion, and facilitating attitudinal changes that support reporting among student-athletes.",2020,"Compared with the control group, the intervention group showed greater increases occurred postintervention and at 1 month in concussion knowledge ( F 1,2648  = 51.3,  P  < .0001), intention to report (oneself,  F 2,2633  = 82.3,  P  < .0001; teammates,  F 2,2624  = 53.9,  P  < .0001), return-to-play protocol knowledge, ( F 2,2632  = 28.4,  P  < .0001), direct subjective norms (oneself,  F 2,2625  = 51.7,  P  < .0001; teammates,  F 2,2644  = 40.6,  P  < .0001), direct perceived behavioral control (oneself,  F 2,2628  = 53.7,  P  < .0001; teammates,  F 2,2615  = 68.2,  P  < .0001) and indirect attitudes (oneself,  F 2,2626  ","['1614 male and female student-athletes from 60 teams at 10 colleges and universities and 8 athletic trainers', 'Eight athletic trainers', 'National Collegiate Athletic Association athletic teams from randomly selected colleges or universities', 'Collegiate Athletes']","['novel peer concussion-education program (PCEP', 'Novel Peer Concussion-Education Program', 'PCEP']","['indirect attitudes (oneself,  F 2,2626', 'return-to-play protocol knowledge', 'concussion knowledge', 'Knowledge, attitudes (oneself and teammates), and concussion occurrence or reporting', 'athletic staff', 'direct subjective norms']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0004083', 'cui_str': 'Association'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}]",1614.0,0.0448974,"Compared with the control group, the intervention group showed greater increases occurred postintervention and at 1 month in concussion knowledge ( F 1,2648  = 51.3,  P  < .0001), intention to report (oneself,  F 2,2633  = 82.3,  P  < .0001; teammates,  F 2,2624  = 53.9,  P  < .0001), return-to-play protocol knowledge, ( F 2,2632  = 28.4,  P  < .0001), direct subjective norms (oneself,  F 2,2625  = 51.7,  P  < .0001; teammates,  F 2,2644  = 40.6,  P  < .0001), direct perceived behavioral control (oneself,  F 2,2628  = 53.7,  P  < .0001; teammates,  F 2,2615  = 68.2,  P  < .0001) and indirect attitudes (oneself,  F 2,2626  ","[{'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'Kneavel', 'Affiliation': 'School of Nursing and Health Sciences, La Salle University, Philadelphia, PA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ernst', 'Affiliation': 'Center for Concussion Education and Research, Chestnut Hill College, Philadelphia, PA.'}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'McCarthy', 'Affiliation': 'Center for Concussion Education and Research, Chestnut Hill College, Philadelphia, PA.'}]",Journal of athletic training,['10.4085/1062-6050-0182.19']
506,32301579,Cognitive bias modification for threat interpretations: Impact on anxiety symptoms and stress reactivity.,"BACKGROUND


Cognitive bias modification for interpretations (CBM-I) is a computerized intervention that has received increasing attention in the last decade as a potential experimental intervention for anxiety. Initial CBM-I trials with clinical populations suggest the potential utility of this approach. However, most CBM-I experiments have been conducted with unaffected samples, few (one or two) training sessions, and have not examined transfer effects to anxiety-related constructs such as stress reactivity.
METHOD


This study compared a 12-session CBM-I intervention (n = 12) to an interpretation control condition (ICC; n = 12) in individuals (N = 24) with elevated trait anxiety on interpretation bias, anxiety symptom, and stress reactivity outcomes (electrodermal activity, heart rate, and respiratory sinus arrhythmia).
RESULTS


Compared to the ICC group, participants assigned to CBM-I experienced significantly greater improvements in interpretation bias and anxiety symptoms by post-intervention 4 weeks later, with impact on anxiety maintained at 1-month follow-up. While CBM-I and ICC groups did not differ in stress reactivity during an acute stressor at pre-intervention, the CBM-I group evidenced improved stress reactivity at post-intervention compared to ICC on two psychophysiological indices, electrodermal activity and heart rate.
CONCLUSIONS


The results of this pilot study suggest that CBM-I may hold promise for reducing anxiety symptoms, as well as impact psychophysiological arousal during an acute stressor.",2020,"Compared to the ICC group, participants assigned to CBM-I experienced significantly greater improvements in interpretation bias and anxiety symptoms by post-intervention 4 weeks later, with impact on anxiety maintained at 1-month follow-up.",[],"['12-session CBM-I intervention (n\u2009=\u200912) to an interpretation control condition (ICC', 'ICC']","['anxiety symptoms and stress reactivity', 'elevated trait anxiety on interpretation bias, anxiety symptom, and stress reactivity outcomes (electrodermal activity, heart rate, and respiratory sinus arrhythmia', 'stress reactivity', 'psychophysiological indices, electrodermal activity and heart rate', 'interpretation bias and anxiety symptoms', 'anxiety symptoms']",[],"[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",24.0,0.0301572,"Compared to the ICC group, participants assigned to CBM-I experienced significantly greater improvements in interpretation bias and anxiety symptoms by post-intervention 4 weeks later, with impact on anxiety maintained at 1-month follow-up.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Rozenman', 'Affiliation': 'Department of Psychology, University of Denver, Denver, Colorado.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Psychology, California State University, Long Beach, California.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Logan', 'Affiliation': 'Department of Psychology, California State University, Long Beach, California.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Goger', 'Affiliation': 'San Diego State University (SDSU)/University of California, San Diego (UCSD), Joint Doctoral Program in Clinical Psychology, San Diego, California.'}]",Depression and anxiety,['10.1002/da.23018']
507,32301591,Improvement of sexual functioning during treatment of MDD with adjunctive pimavanserin: A secondary analysis.,"BACKGROUND


Sexual dysfunction is common among patients with major depressive disorder (MDD). In the CLARITY study, the safety and efficacy of adjunctive pimavanserin, an inverse agonist at 5-HT 2A  receptors, were demonstrated when added to existing treatment for MDD. This analysis provides a detailed assessment of the effects of pimavanserin on sexual function from the CLARITY study.
METHODS


Patients with a diagnosis of MDD in a depressive episode, inadequate response to ongoing antidepressant therapy, and a Montgomery-Åsberg Depression Rating Scale total score >20 were randomized to pimavanserin 34 mg/day or placebo added to ongoing treatment with an immediate revision of all selective serotonin or serotonin-norepinephrine for 5 weeks (Stage 1), and nonresponders (<50% improvement from baseline in Hamilton Depression Rating Scale [HAMD-17]) were re-randomized for an additional 5 week (Stage 2). Effects of pimavanserin on the Massachusetts General Hospital Sexual Functioning Index (MGH-SFI) and HAMD-17 Item 14 (sexual interest) were examined.
RESULTS


Among 203 patients (51 on pimavanserin; 152 on placebo), pimavanserin demonstrated significant improvement from baseline to Week 5 on the MGH-SFI (least square [LS]mean difference -0.634, 95% confidence interval [CI] [-0.964, -0.304]; p = .0002; effect size [ES], Cohen's d: .614). Across Stages 1 and 2, the weighted LSmean difference was -0.468 (95% CI [-0.720, -0.216]; p = .0003) for pimavanserin versus placebo. Mean changes from baseline to Week 5 for MGH-SFI Items 1, 2, 3, and 5 and HAMD Item 14 were significantly (p < .05) greater with pimavanserin versus placebo.
CONCLUSIONS


Adjunctive pimavanserin improved sexual function in patients with MDD. Adding pimavanserin to ongoing treatment for MDD may be especially useful for patients experiencing sexual dysfunction.",2020,"Effects of pimavanserin on the Massachusetts General Hospital Sexual Functioning Index (MGH-SFI) and HAMD-17 Item 14 (sexual interest) were examined.
","['patients experiencing sexual dysfunction', 'patients with MDD', 'Patients with a diagnosis of MDD in a depressive episode, inadequate response to ongoing antidepressant therapy, and a Montgomery-Åsberg Depression Rating Scale total score >20', '203 patients (51 on pimavanserin; 152 on', 'patients with major depressive disorder (MDD']","['adjunctive pimavanserin', 'pimavanserin 34\u2009mg/day or placebo added to ongoing treatment with an immediate revision of all selective serotonin or serotonin-norepinephrine', 'placebo', 'placebo), pimavanserin', 'pimavanserin']","['sexual functioning', 'MGH-SFI', 'Massachusetts General Hospital Sexual Functioning Index (MGH-SFI) and HAMD-17 Item 14 (sexual interest', 'sexual function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1722267', 'cui_str': 'pimavanserin'}]","[{'cui': 'C1722267', 'cui_str': 'pimavanserin'}, {'cui': 'C4704362', 'cui_str': 'pimavanserin 34 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424400', 'cui_str': 'Erotic interest'}]",203.0,0.0952581,"Effects of pimavanserin on the Massachusetts General Hospital Sexual Functioning Index (MGH-SFI) and HAMD-17 Item 14 (sexual interest) were examined.
","[{'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dirks', 'Affiliation': 'Medical Department, ACADIA Pharmaceuticals Inc., San Diego, California.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Medical Department, ACADIA Pharmaceuticals Inc., San Diego, California.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'Medical Department, ACADIA Pharmaceuticals Inc., San Diego, California.'}]",Depression and anxiety,['10.1002/da.23017']
508,32299820,Low-dose versus High-dose Carfilzomib with Dexamethasone (S1304) in Patients with Relapsed-Refractory Multiple Myeloma.,"PURPOSE


Treatment of multiple myeloma (MM) has evolved tremendously and optimal utilization of available therapies will ensure maximal patient benefits.
EXPERIMENTAL DESIGN


We report the SWOG randomized phase 2 trial (S1304) comparing twice-weekly low-dose (27 mg/m 2 ; Arm 1) to high-dose carfilzomib (56 mg/m 2 ; Arm 2), both with dexamethasone, administered for 12 cycles (11 months) for relapsed and/or refractory MM with up to six prior lines of therapy (NCT01903811). The primary endpoint was progression-free survival (PFS), and patients on Arm 1 could crossover to Arm 2 after progression on treatment.
RESULTS


Among 143 enrolled patients, of whom 121 were eligible and analyzable, the overall response rate was 42.8%, with no significant difference between the arms (p=0.113). Also, neither the median PFS (5 months and 8 months, respectively; HR: 1.061, 80% Wald CI 0.821, 1.370; p=0.384) nor the median overall survival were significantly different (26 and 22 months, respectively; HR: 1.149, 80% Wald CI 0.841, 1.571; p=0.284). Sixteen patients crossed over to Arm 2 with a median PFS benefit of 3 months. Certain adverse events (AE) were more frequent in Arm 2, including fatigue, thrombocytopenia and peripheral neuropathy, but there was no significant difference in cardiopulmonary AEs.
CONCLUSIONS


This randomized trial did not support a benefit of fixed-duration, twice-weekly 56 mg/m 2  dosing of carfilzomib over the 27 mg/m 2  dose for the treatment of relapsed and/or refractory MM. However, treatment to progression in earlier patient populations with high-dose carfilzomib using different schedules should still be considered as part of the standard of care.",2020,"Certain adverse events (AE) were more frequent in Arm 2, including fatigue, thrombocytopenia and peripheral neuropathy, but there was no significant difference in cardiopulmonary AEs.
","['multiple myeloma (MM', '143 enrolled patients', 'Patients with Relapsed-Refractory Multiple Myeloma']","['dexamethasone', 'carfilzomib', 'Dexamethasone']","['fatigue, thrombocytopenia and peripheral neuropathy', 'cardiopulmonary AEs', 'median overall survival', 'Certain adverse events (AE', 'overall response rate', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2001856', 'cui_str': 'carfilzomib'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",143.0,0.0870112,"Certain adverse events (AE) were more frequent in Arm 2, including fatigue, thrombocytopenia and peripheral neuropathy, but there was no significant difference in cardiopulmonary AEs.
","[{'ForeName': 'Sikander', 'Initials': 'S', 'LastName': 'Ailawadhi', 'Affiliation': 'Hematology, Mayo Clinic ailawadhi.sikander@mayo.edu.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Sexton', 'Affiliation': 'CRAB.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Lentzsch', 'Affiliation': 'Columbia University Medical Center.'}, {'ForeName': 'Muneer H', 'Initials': 'MH', 'LastName': 'Abidi', 'Affiliation': 'Department of Hematology, Spectrum Health, BMT Program.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Cohen', 'Affiliation': 'Medicine, Abramson Cancer Center, University of Pennsylvania.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Rohren', 'Affiliation': 'Radiology, Baylor College of Medicine.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Heitner', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'Norris Comprehensive Cancer Center.'}, {'ForeName': 'Niklas J', 'Initials': 'NJ', 'LastName': 'Mackler', 'Affiliation': 'Hematology/Oncology, IHA Hematology/Oncology.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Baer', 'Affiliation': 'Medical Oncology, Kaiser Permanente.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Hoering', 'Affiliation': 'Biostatistics, Cancer Research And Biostatistics.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Durie', 'Affiliation': 'Hematology/ Oncology, Cedars-Sinai Outpatient Cancer Center.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'Lymphoma/Myeloma, University of Texas MD Anderson Cancer Center.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-1997']
509,32299860,The effect of exacerbation history on outcomes in the IMPACT trial.,"IMPACT, a 52-week, randomised, double-blind trial, assessed the efficacy and safety of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy  versus  FF/VI or UMEC/VI in patients with symptomatic COPD and a history of exacerbations.Subgroup analyses assessed whether the efficacy of FF/UMEC/VI  versus  FF/VI or UMEC/VI and UMEC/VI  versus  FF/VI varies according to prior exacerbation history, and the combined effects of exacerbation history and blood eosinophil counts. Three subgroups were defined: single moderate (1 moderate/no severe; n=3056 (30%)), frequent moderate (≥2 moderate/no severe; n=4628 (45%)) and severe (≥1 severe/any moderate; n=2671 (26%)). End-points included annual on-treatment moderate/severe exacerbation rate (pre-specified), lung function and health status (both post-hoc).Moderate/severe exacerbation rates (reduction % (95% CI)) were reduced in the FF/UMEC/VI group  versus  FF/VI (single moderate 20% (10-29), frequent moderate 11% (2-19), severe 17% (7-26)) and  versus  UMEC/VI (single moderate 18% (5-29), frequent moderate 29% (21-37), severe 26% (14-35)). Moderate/severe exacerbation rates were reduced in the FF/VI group  versus  UMEC/VI in the frequent moderate subgroup; a numerical reduction was observed in the severe subgroup (single moderate 2% (-12-18), frequent moderate 21% (11-29), severe 11% (-3-22)). Moderate/severe exacerbation rates were lower in the FF/VI group compared with UMEC/VI in patients with higher eosinophil counts. FF/UMEC/VI improved lung function and health status  versus  both dual therapies irrespective of exacerbation subgroup. UMEC/VI improved lung function  versus  FF/VI in all subgroups.Triple therapy was more effective than dual regardless of exacerbation history, consistent with results in the intent-to-treat population. Comparisons between dual therapies were influenced by prior exacerbation history and eosinophil counts.",2020,Moderate/severe exacerbation rates were reduced in the FF/VI group  versus  UMEC/VI in the frequent moderate subgroup; a numerical reduction was observed in the severe subgroup (single moderate: 2% [-12-18]; frequent moderate: 21% [11-29]; severe: 11% [-3-22]).,"['≥2 moderate/no severe; n=4628 [45%]) and severe (≥1 severe/any moderate; n=2671 [26', 'patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations']","['fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy  versus  FF/VI or UMEC/VI', 'Triple therapy']","['severe exacerbation rates', 'annual on-treatment moderate/severe exacerbation rate (pre-specified), lung function, and health status ', 'Moderate/severe exacerbation rates', 'UMEC/VI improved lung function', 'efficacy and safety', 'numerical reduction', 'FF/UMEC/VI improved lung function and health status', 'frequent moderate']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]",,0.597665,Moderate/severe exacerbation rates were reduced in the FF/VI group  versus  UMEC/VI in the frequent moderate subgroup; a numerical reduction was observed in the severe subgroup (single moderate: 2% [-12-18]; frequent moderate: 21% [11-29]; severe: 11% [-3-22]).,"[{'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK d.halpin@nhs.net.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary & Critical Care, Ann Arbor, MI, USA.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GlaxoSmithKline, Stockley Park, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Medical Dept, Herlev and Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, UK.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Pascoe', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Hospitals Trust, Manchester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}]",The European respiratory journal,['10.1183/13993003.01921-2019']
510,32299679,"A multicenter, randomized, placebo-controlled, double-blind phase 3 trial with open-arm comparison indicates safety and efficacy of nephroprotective therapy with ramipril in children with Alport's syndrome.","Children with Alport syndrome develop renal failure early in life. Since the safety and efficacy of preemptive nephroprotective therapy are uncertain we conducted a randomized, placebo-controlled, double-blind trial in 14 German sites of pediatric patients with ramipril for three to six years plus six months follow-up to determine these parameters. Pretreated children and those whose parents refused randomization became an open-arm control, which were compared to prospective real-world data from untreated children. The co-primary endpoints were safety (adverse drug reactions) and efficacy (time to progression). Out of 66 oligosymptomatic children, 22 were randomized and 44 joined the open-arm comparison. Ramipril therapy showed no safety issues (total of 216.4 patient-years on ramipril; adverse event rate-ratio 1.00; 95% confidence interval 0.66-1.53). Although not significant, our results cautiously showed that ramipril therapy was effective: in the randomized arm, Ramipril decreased the risk of disease progression by almost half (hazard ratio 0.51 (0.12-2.20)), diminished the slope of albuminuria progression and the decline in glomerular filtration. In adjusted analysis, indications of efficacy were supported by prospective data from participants treated open label compared with untreated children, in whom ramipril again seemed to reduce progression by almost half (0.53 (0.22-1.29)). Incorporating these results into the randomized data by Bayesian evidence synthesis resulted in a more precise estimate of the hazard-ratio of 0.52 (0.19-1.39). Thus, our study shows the safety of early initiation of therapy and supports the hope to slow renal failure by many years, emphasizing the value of preemptive therapy. Hence, screening programs for glomerular hematuria in children and young adults could benefit from inclusion of genetic testing for Alport-related gene-variants.",2020,Ramipril therapy showed no safety issues (total of 216.4 patient-years on ramipril; adverse event rate-ratio 1.00; 95% confidence interval 0.66-1.53).,"['66 oligosymptomatic children', 'Children with Alport syndrome develop renal failure early in life', 'children and young adults', ""children with Alport's syndrome"", '14 German sites of pediatric patients with ramipril for three to six years plus six months']","['placebo', 'Ramipril', 'ramipril', 'nephroprotective therapy with ramipril', 'preemptive nephroprotective therapy']","['slope of albuminuria progression', 'safety and efficacy', 'safety (adverse drug reactions) and efficacy (time to progression', 'glomerular filtration', 'reduce progression', 'risk of disease progression']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1567741', 'cui_str': 'Alport syndrome'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C3267042', 'cui_str': 'Nephroprotective therapy'}]","[{'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",66.0,0.200707,Ramipril therapy showed no safety issues (total of 216.4 patient-years on ramipril; adverse event rate-ratio 1.00; 95% confidence interval 0.66-1.53).,"[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gross', 'Affiliation': 'Clinic for Nephrology and Rheumatology, University Medical Center Göttingen, Göttingen, Germany. Electronic address: gross.oliver@med.uni-goettingen.de.'}, {'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Tönshoff', 'Affiliation': ""Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Lutz T', 'Initials': 'LT', 'LastName': 'Weber', 'Affiliation': 'Pediatric Nephrology, Children`s and Adolescents` Hospital, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Pape', 'Affiliation': 'Department of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Latta', 'Affiliation': 'Clementine Kinderhospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Fehrenbach', 'Affiliation': ""Pediatric Nephrology, Children's Hospital, Memmingen, Germany.""}, {'ForeName': 'Baerbel', 'Initials': 'B', 'LastName': 'Lange-Sperandio', 'Affiliation': ""Dr. v. Hauner Children's Hospital, Ludwig Maximilians University, Munich, Germany.""}, {'ForeName': 'Hildegard', 'Initials': 'H', 'LastName': 'Zappel', 'Affiliation': 'Clinic of Pediatrics and Adolescent Medicine, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hoyer', 'Affiliation': 'Pediatric Nephrology, Pediatrics II, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Hagen', 'Initials': 'H', 'LastName': 'Staude', 'Affiliation': ""Pediatric Nephrology, University Children's Hospital Rostock, Rostock, Germany.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'König', 'Affiliation': ""University Children's Hospital Münster, Münster, Germany.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'John', 'Affiliation': ""Division of Pediatric Nephrology, University Children's Hospital, Jena, Germany.""}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Gellermann', 'Affiliation': ""Pediatric Nephrology, Charité Children's Hospital, Berlin, Germany.""}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hoppe', 'Affiliation': 'Division of Pediatric Nephrology, Department of Pediatrics, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Galiano', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, University Hospital, Friedrich-Alexander-University Erlangen, Erlangen, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Hoecker', 'Affiliation': ""Department of Pediatrics I, University Children's Hospital Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Ehren', 'Affiliation': 'Pediatric Nephrology, Children`s and Adolescents` Hospital, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lerch', 'Affiliation': 'Department of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Clifford E', 'Initials': 'CE', 'LastName': 'Kashtan', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Harden', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Boeckhaus', 'Affiliation': 'Clinic for Nephrology and Rheumatology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2019.12.015']
511,32299733,Prospective randomized multicentre comparison on sibling oocytes comparing G-Series media system with antioxidants versus standard G-Series media system.,"RESEARCH QUESTION


Does the inclusion of three antioxidants (A3), acetyl-l-carnitine (ALC), N-acetyl-l-cysteine (NAC) and alpha-lipoic acid (ALA) improve human embryo development and pregnancy potential?
DESIGN


Prospective randomized multicentre comparison of sibling oocytes. A total of 1563 metaphase II oocytes from 133 patients in two IVF centres. Day 3 embryo and day 5/6 blastocyst quality were assessed. Good embryo quality on day 3 was defined as 8 to 10 cells with even cells and low fragmentation; good quality blastocysts as 3BB or greater. Clinical outcome was assessed on transfers of fresh or vitrified-warmed blastocyst on day 5.
RESULTS


Of the two-pronuclei, 40.7% (G-Series) and 50.2% (G-Series with A3 group) resulted in good quality embryos on day 3 (P < 0.05). The implantation rate by fetal sac was 39.2% and 50.6%, and by fetal heartbeat was 37.8% and 47.1% for the G-Series and G-Series with A3 group, respectively. When stratified by female patient age, patients 35-40 years had an implantation rate by fetal sac and heart of 23.5% in the G-Series compared with 57.5% (P < 0.05) and 50.0% (P < 0.05) in the A3 group. The ongoing pregnancies in patients 35-40 years were significantly higher in the A3 group (50%) compared with the control (25.8%) (P < 0.05).
CONCLUSIONS


The presence of antioxidants during IVF and embryo culture for patients 35-40 years resulted in a significant increase in implantation and pregnancy rate. Supplementation of antioxidants to IVF and culture media may therefore improve the viability of human embryos in assisted reproductive technologies, plausibly through the reduction of oxidative stress.",2020,The presence of antioxidants during IVF and embryo culture for patients 35-40 years resulted in a significant increase in implantation and pregnancy rate.,['A total of 1563 metaphase II oocytes from 133 patients in two IVF centres'],"['three antioxidants (A3), acetyl-l-carnitine (ALC), N-acetyl-l-cysteine (NAC) and alpha-lipoic acid (ALA', 'G-Series media system with antioxidants versus standard G-Series media system']","['Good embryo quality', 'implantation rate by fetal sac and heart', 'transfers of fresh or vitrified-warmed blastocyst on day 5', 'implantation and pregnancy rate', 'fetal heartbeat', 'implantation rate by fetal sac', 'good quality embryos']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}]",,0.091776,The presence of antioxidants during IVF and embryo culture for patients 35-40 years resulted in a significant increase in implantation and pregnancy rate.,"[{'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Gardner', 'Affiliation': 'School of BioSciences, University of Melbourne, Parkville, Australia; Melbourne IVF, East Melbourne, Australia. Electronic address: david.gardner@unimelb.edu.au.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kuramoto', 'Affiliation': ""Kuramoto Women's Clinic, Reproductive Medicine, Fukuoka, Japan.""}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Kiba Park Clinic, Reproductive Medicine, Tokyo, Japan.'}, {'ForeName': 'Shigetoshi', 'Initials': 'S', 'LastName': 'Mitzumoto', 'Affiliation': ""Kuramoto Women's Clinic, Reproductive Medicine, Fukuoka, Japan.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Montag', 'Affiliation': 'ilabcomm GmbH, Eisenachstrasse 34, Sankt Augustin, Germany.'}, {'ForeName': 'Atsumi', 'Initials': 'A', 'LastName': 'Yoshida', 'Affiliation': 'Kiba Park Clinic, Reproductive Medicine, Tokyo, Japan.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.026']
512,32299734,A randomized double-blinded non-inferiority trial comparing fentanyl and midazolam with pethidine and diazepam for pain relief during oocyte retrieval.,"RESEARCH QUESTION


Is fentanyl and midazolam non-inferior to pethidine and diazepam in pain relief during oocyte retrieval under conscious sedation?
DESIGN


A randomized double-blinded non-inferiority trial of 170 infertile women undergoing oocyte retrieval under conscious sedation in an assisted reproduction centre. The women were randomized to receive intravenously either 0.1 mg fentanyl and 5 mg midazolam or 25 mg pethidine and 5 mg diazepam, plus paracervical block with 10 ml 1% lignocaine. The primary outcome was abdominal pain level during retrieval assessed by linear visual analogue scale from 0-10. Secondary outcomes included vaginal pain levels during and after retrieval and postoperative abdominal pain levels and side-effects, satisfaction level, clinical pregnancy and ongoing pregnancy rates. A pre-defined non-inferiority margin of 1 for the difference in pain levels between two groups was set.
RESULTS


Vaginal and abdominal pain levels during retrieval were significantly lower in the fentanyl and midazolam group compared with the pethidine and diazepam group (per-protocol analysis, vaginal pain: 1.6 versus 4.3; mean difference: -2.7, 95% CI -3.7, -1.8; P < 0.001; abdominal pain: 2.9 versus 5.2; mean difference: -2.3, 95% CI -3.3 to -1.3; P < 0.001 for non-inferiority). No differences were observed in these pain levels after retrieval. Most women experienced no postoperative side-effects. The fentanyl and midazolam group had better sedation level, satisfaction level on pain relief and satisfaction on the overall retrieval procedure than the pethidine and diazepam group. No significant differences were found in clinical pregnancy and ongoing pregnancy rates between the two groups.
CONCLUSION


The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.",2020,The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.,"['pain relief during oocyte retrieval', '170 infertile women undergoing oocyte retrieval under conscious sedation in an assisted reproduction centre']","['pethidine and 5 mg diazepam, plus paracervical block with 10 ml 1% lignocaine', 'fentanyl and 5 mg midazolam', 'pethidine', 'pethidine and diazepam', 'midazolam', 'diazepam', 'fentanyl and midazolam']","['postoperative side-effects', 'clinical pregnancy and ongoing pregnancy rates', 'pain levels', 'Vaginal and abdominal pain levels', 'vaginal and abdominal pain levels', 'vaginal pain levels during and after retrieval and postoperative abdominal pain levels and side-effects, satisfaction level, clinical pregnancy and ongoing pregnancy rates', 'abdominal pain', 'abdominal pain level during retrieval assessed by linear visual analogue scale', 'sedation level, satisfaction level on pain relief and satisfaction on the overall retrieval procedure']","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030401', 'cui_str': 'Paracervical block anesthesia'}, {'cui': 'C2744579', 'cui_str': 'ATP8A2 protein, human'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0236082', 'cui_str': 'Vaginal pain'}, {'cui': 'C4047372', 'cui_str': 'Postoperative abdominal pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",170.0,0.597173,The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.,"[{'ForeName': 'Shui Fan', 'Initials': 'SF', 'LastName': 'Lai', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong. Electronic address: lsf087@ha.org.hk.'}, {'ForeName': 'Mei Ting', 'Initials': 'MT', 'LastName': 'Lam', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Hang Wun Raymond', 'Initials': 'HWR', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ernest Hung Yu', 'Initials': 'EHY', 'LastName': 'Nga', 'Affiliation': 'Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.021']
513,32302791,"A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol.","This randomized trial will evaluate the mechanisms of three chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS). We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level. The shared versus specific role of these mechanisms across the three treatments will be evaluated during treatment (Primary Aim), and immediately post-treatment to examine relapse mechanisms (Secondary Aim). We will enroll 300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study. Participants will be randomly assigned to eight, 1.5 h telehealth group sessions of CT, MM, or AS. Mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via random cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. The primary outcome will be measured by the PROMIS 5-item Pain Interference scale. Structural equation modeling (SEM) will be used to test the primary aims. This study is pre-registered on clinicaltrials.gov (Identifier: NCT03687762). This study will determine the temporal sequence of lagged mediation effects to evaluate rates of change in outcome as a function of change in mediators. The findings will provide an empirical basis for enhancing and streamlining psychosocial chronic pain interventions. Further, results will guide future efforts towards optimizing maintenance of gains to effectively reduce relapse risk.",2020,"We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level.","['chronic pain', '300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study']","['Structural equation modeling (SEM', 'telehealth group sessions of CT, MM, or AS', 'chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS', 'cognitive, behavioral and mindfulness-based psychosocial treatments']","['Pain Interference scale', 'cognitive content, cognitive process, and/or activity level', 'PROMIS 5-item']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0681947', 'cui_str': 'Structural Equation Modeling'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",300.0,0.103487,"We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level.","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Day', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia. Electronic address: m.day@uq.edu.au.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Ward', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Friedly', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Thorn', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Ciol', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mendoza', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Chan', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Battalio', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Borckardt', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106000']
514,32298697,Molecular profiling of allergen-specific antibody responses may enhance success of specific immunotherapy.,"BACKGROUND


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


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


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


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


Stratification of patients with HDM allergy according to molecular sensitization profiles and molecular monitoring of AIT-induced IgG responses may enhance the success of AIT.",2020,induced protective IgG mainly against Der p 1 and Der p 2 and to a lower extent to Der,"['House dust mites (HDM', 'HDM allergic patients', 'Serum and nasal secretion samples from HDM allergic patients (n=24) (baseline, 7, 15, 33 and 52 weeks) who had received one year treatment with a well-defined subcutaneous AIT form (Alutard SQ 510']","['ImmunoCAP ISAC technology', 'placebo-controlled allergen-specific immunotherapy (AIT']","['reduction of symptoms determined by combined symptom medication score (CSMS) and visual analogue (VAS', 'clinical efficacy']","[{'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0524581', 'cui_str': 'House dust'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442825', 'cui_str': 'Well defined'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C4517800', 'cui_str': '510'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",510.0,0.0767799,induced protective IgG mainly against Der p 1 and Der p 2 and to a lower extent to Der,"[{'ForeName': 'Azahara', 'Initials': 'A', 'LastName': 'Rodríguez-Domínguez', 'Affiliation': 'Department of Pathophysiology and Allergy Research, Division of Immunopathology, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Vienna and Krems, Austria.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Berings', 'Affiliation': 'Upper Airways Research Laboratory, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rohrbach', 'Affiliation': 'Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité-University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Huey-Jy', 'Initials': 'HJ', 'LastName': 'Huang', 'Affiliation': 'Department of Pathophysiology and Allergy Research, Division of Immunopathology, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Vienna and Krems, Austria.'}, {'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Curin', 'Affiliation': 'Department of Pathophysiology and Allergy Research, Division of Immunopathology, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Vienna and Krems, Austria.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gevaert', 'Affiliation': 'Upper Airways Research Laboratory, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Paolo M', 'Initials': 'PM', 'LastName': 'Matricardi', 'Affiliation': 'Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité-University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Valenta', 'Affiliation': 'Department of Pathophysiology and Allergy Research, Division of Immunopathology, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Vienna and Krems, Austria; NRC Institute of Immunology, Federal Biomedical Agency of Russia, Moscow; Department of Clinical Immunology and Allergy, Sechenov First State Medical University, Moscow, Russia; Karl Landsteiner University of Health Sciences, Krems, Austria.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Vrtala', 'Affiliation': 'Department of Pathophysiology and Allergy Research, Division of Immunopathology, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Vienna and Krems, Austria. Electronic address: susanne.vrtala@meduniwien.ac.at.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.03.029']
515,32304676,"Impact of sugar taxes and front-of-package nutrition labels on purchases of protein, calcium and fibre.","Taxes and front-of-package (FOP) labels can be effective interventions for reducing consumption of sugar, saturated fat, and sodium; however, few studies have examined their impact on intake of 'positive' nutrients. The current study explored the impact of sugar taxes and FOP labels on the protein, calcium and fibre density of snack food purchases. A total of 3584 Canadians aged 13 years and older participated in an experimental marketplace using a 3 × 8 between-within group experiment. Participants received $5 and viewed images of 20 snack food products available for purchase. Participants were randomized to one of five FOP label conditions (no label, high in, multiple traffic light, health star rating, or nutrition grade) and completed three within-subject purchasing tasks with different sugar tax conditions (no tax, 20%, tiered). Upon conclusion, participants received the product and any change from one of the purchasing tasks. The results indicate that participants purchased snack foods with higher fibre density when either sugar tax was applied (+0.1 g/100 kcal) compared to no tax, and when they were assigned to see the multiple traffic light (+0.4 g/100 kcal) or health star rating (+0.3 g/100 kcal) FOP labels, compared to no FOP label. There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions. Overall, the findings suggest that as consumers respond to tax or labelling policies by moving away from sugars, sodium, and saturated fat, there may be no downside-or even an increase-in 'positive' nutrient density.",2020,There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions.,['3584 Canadians aged 13\u202fyears and older participated in an experimental marketplace using a 3\u202f×\u202f8 between-within group experiment'],"['sugar taxes and front-of-package nutrition labels', 'multiple traffic light (+0.4\u202fg/100\u202fkcal) or health star rating (+0.3\u202fg/100\u202fkcal) FOP labels', 'sugar taxes and FOP labels', 'Taxes and front-of-package (FOP) labels', 'FOP label conditions (no label, high in, multiple traffic light, health star rating, or nutrition grade) and completed three within-subject purchasing tasks with different sugar tax conditions (no tax, 20%, tiered']","['purchases of protein, calcium and fibre']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0039371', 'cui_str': 'Tax'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}]",3584.0,0.0287178,There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions.,"[{'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Acton', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, Canada. Electronic address: rbacton@uwaterloo.ca.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, Canada. Electronic address: david.hammond@uwaterloo.ca.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106091']
516,32302790,"Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS): A prospective, multi-centre therapeutic phase II parallel Randomised Control Trial.","INTRODUCTION


Focal therapy (FT) targets individual areas of cancer within the prostate, providing oncological control with minimal side-effects. Early evidence demonstrates encouraging short-medium-term outcomes. With no randomized controlled trials (RCT) comparing FT to radical therapies, Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (CHRONOS) will compare the cancer control of these two strategies.
PATIENTS AND METHODS


CHRONOS is a parallel phase II RCT for patients with clinically significant non-metastatic prostate cancer, dependent upon clinician/patient decision, patients will enrol into either CHRONOS-A or CHRONOS-B. CHRONOS-A will randomize patients to either radical treatment or FT. CHRONOS-B is a multi-arm, multistage RCT comparing focal therapy alone to FT with neoadjuvant agents that might improve the current focal therapy outcomes. An internal pilot will determine the feasibility of, and compliance to, randomization. The proposed definitive study plans to recruit and randomize 1190 patients into CHRONOS-A and 1260 patients into CHRONOS-B.
RESULTS


Primary outcome in CHRONOS-A is progression-free survival (transition to salvage local or systemic therapy, development of metastases or prostate-cancer-related mortality) and in CHRONOS-B is failure-free survival (includes the above definition and recurrence of clinically significant prostate cancer after initial FT). Secondary outcomes include adverse events, health economics and functional outcomes measured using validated questionnaires. CHRONOS is powered to assess non-inferiority of FT compared to radical therapy in CHRONOS-A, and superiority of neoadjuvant agents with FT in CHRONOS-B.
CONCLUSION


CHRONOS will assess the oncological outcomes after FT compared to radical therapy and whether neoadjuvant treatments improve cancer control following one FT session.",2020,"CHRONOS is powered to assess non-inferiority of FT compared to radical therapy in CHRONOS-A, and superiority of neoadjuvant agents with FT in CHRONOS-B.
CONCLUSION


CHRONOS will assess the oncological outcomes after FT compared to radical therapy and whether neoadjuvant treatments improve cancer control following one FT session.","['patients with clinically significant non-metastatic prostate cancer', 'prostate cancer (IP4-CHRONOS', '1190 patients into CHRONOS-A and 1260 patients']","['Novel Surgery', 'radical treatment or FT']","['adverse events, health economics and functional outcomes measured using validated questionnaires', 'progression-free survival (transition to salvage local or systemic therapy, development of metastases or prostate-cancer-related mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4759295', 'cui_str': 'Non-metastatic prostate cancer'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1260.0,0.0411896,"CHRONOS is powered to assess non-inferiority of FT compared to radical therapy in CHRONOS-A, and superiority of neoadjuvant agents with FT in CHRONOS-B.
CONCLUSION


CHRONOS will assess the oncological outcomes after FT compared to radical therapy and whether neoadjuvant treatments improve cancer control following one FT session.","[{'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Reddy', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK. Electronic address: Deepika.reddy06@imperial.ac.uk.'}, {'ForeName': 'Taimur T', 'Initials': 'TT', 'LastName': 'Shah', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Dudderidge', 'Affiliation': 'Department of Urology, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'McCracken', 'Affiliation': 'Department of Urology, Sunderland Royal Hospital, Sunderland, UK; Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Manit', 'Initials': 'M', 'LastName': 'Arya', 'Affiliation': 'Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK; Department of Surgery and Interventional Sciences, University College London, University College Hospital, London, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Dobbs', 'Affiliation': 'Patient and Public Representative, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Emberton', 'Affiliation': 'Department of Surgery and Interventional Sciences, University College London, University College Hospital, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fiorentino', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Day', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Andrew Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sydes', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Winkler', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Hashim U', 'Initials': 'HU', 'LastName': 'Ahmed', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105999']
517,32026568,The impact of maternal supplementation during pregnancy and the first 6 months postpartum on the growth status of the next child born after the intervention period: Follow-up results from Bangladesh and Ghana.,"Pregnancy and breastfeeding make demands on maternal nutrient stores. The extent of depletion and the degree to which nutrient stores are replenished between pregnancies has implications for a mother's nutritional status at conception of the subsequent child and therefore that child's birth outcomes and growth. Using follow-up data collected several years after a randomized effectiveness trial conducted in rural Bangladesh and a randomized efficacy trial conducted in semiurban Ghana, we evaluated the impact of maternal supplementation with small-quantity lipid-based nutrient supplements (LNS) or multiple micronutrients (MMN) through pregnancy (the index pregnancy) and 6 months postpartum on the growth status of the next living younger sibling conceived and born after the index pregnancy. In both Bangladesh (n = 472 younger siblings) and Ghana (n = 327 younger siblings), there were no overall differences in the growth status or the prevalence of undernutrition among younger siblings whose mothers had received LNS (or MMN, Ghana only) during and after the index pregnancy compared with the younger siblings of mothers who had received iron plus folic acid (IFA) during the index pregnancy (Ghana) or during and for 3 months after the index pregnancy (Bangladesh). These findings do not indicate that preconception nutrition interventions do not improve child growth. Rather, they suggest that any benefits of maternal LNS or MMN supplementation during one pregnancy and for 6 months postpartum are unlikely to extend to the growth of her next child beyond any effects due to IFA alone.",2020,"In both Bangladesh (n = 472 younger siblings) and Ghana (n = 327 younger siblings), there were no overall differences in the growth status or the prevalence of undernutrition among younger siblings whose mothers had received LNS (or MMN, Ghana only) during and after the index pregnancy compared with the younger siblings of mothers who had received iron plus folic acid (IFA) during the index pregnancy (Ghana) or during and for 3 months after the index pregnancy (Bangladesh).","['rural Bangladesh and a randomized efficacy trial conducted in semiurban Ghana', 'In both Bangladesh (n = 472 younger siblings) and Ghana (n = 327 younger siblings']","['maternal supplementation with small-quantity lipid-based nutrient supplements (LNS) or multiple micronutrients (MMN', 'maternal supplementation', 'LNS', 'iron plus folic acid (IFA', 'maternal LNS or MMN supplementation']",['maternal nutrient stores'],"[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]",472.0,0.0327532,"In both Bangladesh (n = 472 younger siblings) and Ghana (n = 327 younger siblings), there were no overall differences in the growth status or the prevalence of undernutrition among younger siblings whose mothers had received LNS (or MMN, Ghana only) during and after the index pregnancy compared with the younger siblings of mothers who had received iron plus folic acid (IFA) during the index pregnancy (Ghana) or during and for 3 months after the index pregnancy (Bangladesh).","[{'ForeName': 'Katherine P', 'Initials': 'KP', 'LastName': 'Adams', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Adu-Afarwuah', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Malay K', 'Initials': 'MK', 'LastName': 'Mridha', 'Affiliation': 'School of Public Health, BRAC University, Dhaka, Bangladesh.'}, {'ForeName': 'Brietta M', 'Initials': 'BM', 'LastName': 'Oaks', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, Rhode Island, USA.'}, {'ForeName': 'Susana L', 'Initials': 'SL', 'LastName': 'Matias', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California, Berkeley, Berkeley, California, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Sika M', 'Initials': 'SM', 'LastName': 'Kumordzie', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Okronipa', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Maku E', 'Initials': 'ME', 'LastName': 'Ocansey', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12927']
518,32304731,Nudging while online grocery shopping: A randomized feasibility trial to enhance nutrition in individuals with food insecurity.,"Food insecurity, the inability to acquire adequate food due to insufficient resources for food, is associated with an increased risk for obesity and associated health problems. This study assessed the feasibility and initial efficacy of a prefilled online grocery shopping cart (i.e., default option) in promoting healthier grocery purchases in individuals with food insecurity. Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits. Compared to nutrition education, the default shopping cart resulted in the purchase of significantly more ounces of whole grains (Mean Difference [M diff ] = -4.05; 95% Confidence Interval [CI] = -6.14, -1.96; p < .001), cups of fruits (M diff  = -1.51; 95% CI = -2.51, -0.59; p = .002) and vegetables (M diff  = -2.21; 95% CI = -4.01, -0.41; p = .02), foods higher in fiber (mg; M diff  = -15.65; 95% CI = -27.43, -3.87; p = .01), and lower in sodium (mg; M diff  = 1642.66; 95% CI = 660.85, 2624.48; p = .002), cholesterol (mg; M diff  = 463.86; 95% CI = 198.76, 728.96; p = .001), and grams of fat (M diff  = 75.42; 95% CI = 42.81, 108.03; p < .001) and saturated fat (M diff  = 26.20; 95% CI = 14.07, 38.34; p < .001). The use of a default online shopping cart appears to improve nutritional quality of food purchases in individuals facing financial constraints.",2020,"Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits.","['individuals with food insecurity', 'Fifty participants recruited from food pantries in New York in 2018 were randomized to', 'individuals facing financial constraints']","['review nutrition information before purchasing groceries online (n\u202f=\u202f23) or modify a prefilled, nutritionally balanced online shopping cart (n\u202f=\u202f27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits', 'prefilled online grocery shopping cart (i.e., default option']","['grams of fat (M diff', 'nutritional quality of food purchases', 'saturated fat', 'feasibility and initial efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0441061', 'cui_str': 'Shopping cart'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C3494397', 'cui_str': 'SNAP Program'}]","[{'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C3489446', 'cui_str': 'Nutritive Quality'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",50.0,0.161297,"Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits.","[{'ForeName': 'Jaime A', 'Initials': 'JA', 'LastName': 'Coffino', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, USA. Electronic address: jcoffino@albany.edu.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Udo', 'Affiliation': 'Department of Health Policy, Management, and Behavior, University at Albany, State University of New York, USA.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hormes', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, USA.'}]",Appetite,['10.1016/j.appet.2020.104714']
519,32303810,High contextual interference in perturbation-based balance training leads to persistent and generalizable stability gains of compensatory limb movements.,"Reactive responses to balance perturbations have been shown to be improved by training. This investigation aimed to compare the effects of block and random training perturbation schedules on stability gains of compensatory arm and leg movements in response to unpredictable large-magnitude balance perturbations. Perturbations were produced by means of sudden displacements of the support base, associating mode (rotation, translation, combined), direction, and velocity of platform motion. Healthy young participants were assigned to one of three groups: random, block, and control. For the random group, perturbation sequence was unpredictable. For the block group, each balance perturbation was repeated over blocks of four trials. Controls were tested only, serving as reference of first trial responses in the post-test. Evaluation was made through a scale rating stability of compensatory arm and leg movements (CALM). We probed immediate and persistence gains (1-week retention), in addition to generalizability to perturbations of higher velocity and to dual-tasking (mental subtraction). In the post-test both the block and random groups achieved higher leg and global scores in comparison with controls in the most challenging perturbations. In retention and transfer tests, results for the global score indicated higher values for the random than for the block and control groups. These results support the conclusion that high but not low contextual interference in perturbation-based balance training leads to enduring and generalizable increased stability gains of compensatory limb movements in response to unpredictable balance perturbations.",2020,In the post-test both the block and random groups achieved higher leg and global scores in comparison with controls in the most challenging perturbations.,['Healthy young participants'],[],"['stability gains of compensatory arm and leg movements', 'sudden displacements of the support base, associating mode (rotation, translation, combined), direction, and velocity of platform motion', 'scale rating stability of compensatory arm and leg movements (CALM', 'higher leg and global scores']","[{'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1276802', 'cui_str': 'Sudden'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0268591,In the post-test both the block and random groups achieved higher leg and global scores in comparison with controls in the most challenging perturbations.,"[{'ForeName': 'Patrícia Sayuri', 'Initials': 'PS', 'LastName': 'Takazono', 'Affiliation': 'Human Motor Systems Laboratory, School of Physical Education and Sport, University of São Paulo, Av. Prof. Mello Moraes, 65. Cidade Universitária, USP, São Paulo, SP, 05508-030, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ribeiro de Souza', 'Affiliation': 'Human Motor Systems Laboratory, School of Physical Education and Sport, University of São Paulo, Av. Prof. Mello Moraes, 65. Cidade Universitária, USP, São Paulo, SP, 05508-030, Brazil.'}, {'ForeName': 'Júlia', 'Initials': 'J', 'LastName': 'Ávila de Oliveira', 'Affiliation': 'Human Motor Systems Laboratory, School of Physical Education and Sport, University of São Paulo, Av. Prof. Mello Moraes, 65. Cidade Universitária, USP, São Paulo, SP, 05508-030, Brazil.'}, {'ForeName': 'Daniel Boari', 'Initials': 'DB', 'LastName': 'Coelho', 'Affiliation': 'Human Motor Systems Laboratory, School of Physical Education and Sport, University of São Paulo, Av. Prof. Mello Moraes, 65. Cidade Universitária, USP, São Paulo, SP, 05508-030, Brazil.'}, {'ForeName': 'Luis Augusto', 'Initials': 'LA', 'LastName': 'Teixeira', 'Affiliation': 'Human Motor Systems Laboratory, School of Physical Education and Sport, University of São Paulo, Av. Prof. Mello Moraes, 65. Cidade Universitária, USP, São Paulo, SP, 05508-030, Brazil. lateixei@usp.br.'}]",Experimental brain research,['10.1007/s00221-020-05806-x']
520,31424182,Effect of single-session transcranial direct current stimulation on cognition in Parkinson's disease.,"AIMS


Nonmotor symptoms (NMS) such as cognitive impairment and impulse-control disorders in Parkinson's disease (PD) remain a therapeutic challenge. Transcranial direct current stimulation (tDCS) has emerged as a promising alternative, although its immediate effects on NMS have been less well defined. In this randomized, sham-controlled, crossover study, we aimed to explore the single-session tDCS effects on cognitive performance in PD.
METHODS


Ten nondemented patients with PD completed two sessions in counterbalanced order, receiving 20 minutes of either 2 mA anodal or sham tDCS over the left dorsolateral prefrontal cortex (DLPFC). During stimulation, they performed the visual working memory and go/no-go tasks. Performance of the tasks was compared between the two conditions.
RESULTS


Single-session anodal tDCS over the left DLPFC did not significantly improve cognitive tasks in PD compared with sham (P > .05).
CONCLUSION


Single-session tDCS is ineffective in improving visual working memory and inhibitory control in PD. Further research may worth exploring alternative tDCS parameters, ideally with repeated sessions and concomitant training.",2019,"RESULTS


Single-session anodal tDCS over the left DLPFC did not significantly improve cognitive tasks in PD compared with sham (P > .05).
","[""Parkinson's disease (PD"", 'Ten nondemented patients with PD completed two sessions in counterbalanced order', ""Parkinson's disease""]","['single-session transcranial direct current stimulation', 'receiving 20\xa0minutes of either 2\xa0mA anodal or sham tDCS', 'Transcranial direct current stimulation (tDCS']","['cognitive performance', 'cognitive tasks']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]",[],,0.0460988,"RESULTS


Single-session anodal tDCS over the left DLPFC did not significantly improve cognitive tasks in PD compared with sham (P > .05).
","[{'ForeName': 'Chi-Ieong', 'Initials': 'CI', 'LastName': 'Lau', 'Affiliation': 'Dementia Center, Department of Neurology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Mu-N', 'Initials': 'MN', 'LastName': 'Liu', 'Affiliation': 'Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Kae-Chwen', 'Initials': 'KC', 'LastName': 'Chang', 'Affiliation': 'Department of Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': 'Department of Neurology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chyi-Huey', 'Initials': 'CH', 'LastName': 'Bai', 'Affiliation': 'Department of Public Health, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Ching-Shiang', 'Initials': 'CS', 'LastName': 'Tseng', 'Affiliation': 'Department of Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Walsh', 'Affiliation': 'Applied Cognitive Neuroscience Group, Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Han-Cheng', 'Initials': 'HC', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}]",CNS neuroscience & therapeutics,['10.1111/cns.13210']
521,32302693,"Evaluation of febuxostat initiation during an acute gout attack: A prospective, randomized clinical trial.","OBJECTIVE


Urate-lowering treatment (ULT) is recommended in gout management. However, initiation of ULT during an acute gout flare is still inconclusive. This study aimed to evaluate the efficacy and safety of the ULT febuxostat administered at initiation of an acute gout attack.
METHODS


A prospective randomized controlled clinical trial was conducted for 12 weeks in primary gout patients who were admitted with acute gout attacks. Subjects were randomly assigned to the febuxostat group in which febuxostat, 40mg daily, was administered in the primary care setting for attacks, or to the control group in which febuxostat, 40mg daily, was administered after the attacks. All patients received adequate anti-inflammatory and analgesic therapies. Serum urate (SU) levels were monitored throughout the study. Pain, measured using a visual analogue scale (VAS), and gout recurrence rate were used as primary outcomes. Flare-related inflammation biomarkers were selected as secondary outcomes.
RESULTS


Fifty-two patients completed the study (febuxostat group: n=28; control group: n=24). No significant differences were detected in VAS scores between the two groups over the first 14-day observation period (P>0.05). Administration of febuxostat decreased SU levels significantly during the first 2-week period. However, the gout recurrent rate or gout flare-related inflammation indicators did not change in the febuxostat or control groups. Treatment-related adverse events were mild and similar between groups.
CONCLUSION


Initiation of the urate-lowering drug febuxostat during an acute gout attack caused no significant difference in daily pain, recurrent flares, or adverse effects. The treatment significantly decreased SU levels in the early stage and might have potential long-term benefits in these patients.",2020,No significant differences were detected in VAS scores between the two groups over the first 14-day observation period (P > 0.05).,"['Fifty-two patients completed the study (febuxostat group: n = 28; control group: n = 24', 'Acute Gout Attack', '12 weeks in primary gout patients who were admitted with acute gout attacks']","['control group in which febuxostat', 'adequate anti-inflammatory and analgesic therapies', 'Febuxostat Initiation', 'ULT', 'febuxostat', 'febuxostat group in which febuxostat', 'Urate-lowering treatment (ULT', 'ULT febuxostat']","['adverse events', 'SU levels', 'gout recurrent rate or gout flare-related inflammation indicators', 'daily pain, recurrent flares, or adverse effects', 'Flare-related inflammation biomarkers', 'efficacy and safety', 'Serum urate (SU) levels', 'Pain, measured using a visual analogue scale (VAS), and gout recurrence rate', 'VAS scores']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0149896', 'cui_str': 'Primary gout'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0149896', 'cui_str': 'Primary gout'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",52.0,0.111008,No significant differences were detected in VAS scores between the two groups over the first 14-day observation period (P > 0.05).,"[{'ForeName': 'Ruixia', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Department of Endocrinology and Metabolism, the Affiliated Hospital of Qingdao University, 266003 Qingdao, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Department of Endocrinology and Metabolism, the Affiliated Hospital of Qingdao University, 266003 Qingdao, China; Institute of Metabolic Diseases, Qingdao University, 266003 Qingdao, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Department of Endocrinology and Metabolism, the Affiliated Hospital of Qingdao University, 266003 Qingdao, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Department of Endocrinology and Metabolism, the Affiliated Hospital of Qingdao University, 266003 Qingdao, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xin', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Department of Endocrinology and Metabolism, the Affiliated Hospital of Qingdao University, 266003 Qingdao, China.'}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Department of Endocrinology and Metabolism, the Affiliated Hospital of Qingdao University, 266003 Qingdao, China; Institute of Metabolic Diseases, Qingdao University, 266003 Qingdao, China. Electronic address: lichanggui@medmail.com.cn.'}]",Joint bone spine,['10.1016/j.jbspin.2020.03.017']
522,31984480,Oral Janus kinase inhibitors for maintenance of remission in ulcerative colitis.,"BACKGROUND


Tofacitinib is an oral Janus kinase (JAK) inhibitor which blocks cytokine signaling involved in the pathogenesis of autoimmune diseases including ulcerative colitis (UC). The etiology of UC is poorly understood, however research suggests the development and progression of the disease is due to a dysregulated immune response leading to inflammation of the colonic mucosa in genetically predisposed individuals. Additional medications are currently required since some patients do not respond to the available medications and some medications are associated with serious adverse events (SAEs). JAK inhibitors have been widely studied in diseases including rheumatoid arthritis and Crohn's disease and may represent a promising and novel therapeutic option for the treatment of UC.
OBJECTIVES


The primary objective was to assess the efficacy and safety of oral JAK inhibitors for the maintenance of remission in participants with quiescent UC.
SEARCH METHODS


We searched the following databases from inception to 20 September 2019: MEDLINE, Embase, CENTRAL, and the Cochrane IBD Group Specialized Register, WHO trials registry and clinicaltrials.gov. References and conference abstracts were searched to identify additional studies.
SELECTION CRITERIA


Randomized control trial (RCTs) in which an oral JAK inhibitor was compared with placebo or active comparator in the treatment of quiescent UC were eligible for inclusion.
DATA COLLECTION AND ANALYSIS


Two review authors independently screened studies for inclusion and extraction. Bias was assessed using the Cochrane 'Risk of bias' tool. The primary outcome was the proportion of participants who failed to maintain remission as defined by any included studies. Secondary outcomes included failure to maintain clinical response, failure to maintain endoscopic remission, failure to maintain endoscopic response, disease-specific quality of life, adverse events (AEs), withdrawal due to AEs and SAEs. We calculated the risk ratio (RR) and 95% confidence intervals (95% CI) for each dichotomous outcome. Data were analyzed on an intention-to-treat basis. The overall certainty of the evidence supporting the outcomes was evaluated using the GRADE criteria.
MAIN RESULTS


One RCT (593 participants) including patients with moderately to severely active UC met the inclusion criteria. Patients were randomly assigned in a 1:1:1 ratio to receive maintenance therapy with tofacitinib at 5 mg twice daily, 10 mg twice daily or placebo for 52 weeks. The primary endpoint was remission at 52 weeks and the secondary endpoints included mucosal healing at 52 weeks, sustained remission at 24 and 52 weeks and glucocorticosteroid-free remission. This study was rated as low risk of bias. The study reported on most of the pre-specified primary and secondary outcomes for this review including clinical remission, clinical response, endoscopic remission, AEs, SAEs and withdrawal due to AEs. However, the included study did not report on endoscopic response or disease-specific quality of life. Sixty-three per cent (247/395) of tofacitinib participants failed to maintain clinical remission at 52 weeks compared to 89% (176/198) of placebo participants (RR 0.70, 95% CI 0.64 to 0.77; high-certainty evidence). Forty-three per cent (171/395) of tofacitinib participants failed to maintain clinical response at 52 weeks compared to 80% (158/198) of placebo participants (RR 0.54, 95% CI 0.48 to 0.62; high-certainty evidence). Eighty-four per cent (333/395) of tofacitinib participants failed to maintain endoscopic remission at 52 weeks compared to 96% (190/198) of placebo participants (RR 0.88, 95% CI 0.83 to 0.92; high-certainty evidence). AEs were reported in 76% (299/394) of tofacitinib participants compared with 75% (149/198) of placebo participants (RR 1.01, 95% CI 0.92 to 1.11; high-certainty evidence). Commonly reported AEs included worsening UC, nasopharyngitis, arthralgia (joint pain)and headache. SAEs were reported in 5% (21/394) of tofacitinib participants compared with 7% (13/198) of placebo participants (RR 0.81, 95% CI 0.42 to 1.59; low-certainty evidence). SAEs included non-melanoma skin cancers, cardiovascular events, cancer other than non-melanoma skin cancer, Bowen's disease, skin papilloma and uterine leiomyoma (a tumour in the uterus). There was a higher proportion of participants who withdrew due to an AE in the placebo group compared to the tofacitinib group. Nine per cent (37/394) of participants taking tofacitinib withdrew due to an AE compared to 19% (37/198) of participants taking placebo (RR 0.50, 95% CI 0.33 to 0.77; moderate-certainty evidence). The most common reason for withdrawal due to an AE was worsening UC. The included study did not report on endoscopic response or on mean disease-specific quality of life scores.
AUTHORS' CONCLUSIONS


High-certainty evidence suggests that tofacitinib is superior to placebo for maintenance of clinical and endoscopic remission at 52 weeks in participants with moderate-to-severe UC in remission. The optimal dose of tofacitinib for maintenance therapy is unknown. High-certainty evidence suggests that there is no increased risk of AEs with tofacitinib compared to placebo. However, we are uncertain about the effect of tofacitinib on SAEs due to the low number of events. Further studies are required to look at the long-term effectiveness and safety of using tofacitinib and other oral JAK inhibitors as maintenance therapy in participants with moderate-to-severe UC in remission.",2020,"Nine per cent (37/394) of participants taking tofacitinib withdrew due to an AE compared to 19% (37/198) of participants taking placebo (RR 0.50, 95% CI 0.33 to 0.77; moderate-certainty evidence).","['participants with moderate-to-severe UC in remission', 'participants with quiescent UC', 'quiescent UC were eligible for inclusion']","['oral JAK inhibitors', 'tofacitinib', 'maintenance therapy with tofacitinib', 'placebo', 'Oral Janus kinase inhibitors']","['endoscopic response or disease-specific quality of life', 'failure to maintain clinical response, failure to maintain endoscopic remission, failure to maintain endoscopic response, disease-specific quality of life, adverse events (AEs), withdrawal due to AEs and SAEs', 'mucosal healing at 52 weeks, sustained remission', 'efficacy and safety', 'SAEs', 'endoscopic response or on mean disease-specific quality of life scores', 'clinical remission, clinical response, endoscopic remission, AEs, SAEs and withdrawal due to AEs', 'maintain clinical response', 'maintain endoscopic remission', 'maintain clinical remission', 'worsening UC, nasopharyngitis, arthralgia (joint pain)and headache', 'proportion of participants who failed to maintain remission', 'risk ratio (RR', ""non-melanoma skin cancers, cardiovascular events, cancer other than non-melanoma skin cancer, Bowen's disease, skin papilloma and uterine leiomyoma""]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3854325', 'cui_str': 'JAK Inhibitors'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521962', 'cui_str': 'Janus kinase inhibitor'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0151779', 'cui_str': 'Familial Atypical Mole-Malignant Melanoma Syndrome'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0006079', 'cui_str': ""Bowen's Disease""}, {'cui': 'C0347390', 'cui_str': 'Papilloma of skin (disorder)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}]",,0.687987,"Nine per cent (37/394) of participants taking tofacitinib withdrew due to an AE compared to 19% (37/198) of participants taking placebo (RR 0.50, 95% CI 0.33 to 0.77; moderate-certainty evidence).","[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Davies', 'Affiliation': 'University of Western Ontario, Schulich School of Medicine & Dentistry, London, ON, Canada.'}, {'ForeName': 'Isra M', 'Initials': 'IM', 'LastName': 'Hussein', 'Affiliation': ""University of Toronto, Faculty of Medicine, 1 King's College Circle, Toronto, ON, Canada, M5S 1A8.""}, {'ForeName': 'Tran M', 'Initials': 'TM', 'LastName': 'Nguyen', 'Affiliation': 'Robarts Clinical Trials, 100 Dundas Street, Suite 200, London, ON, Canada.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Parker', 'Affiliation': 'Robarts Clinical Trials, 100 Dundas Street, Suite 200, London, ON, Canada.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': 'University of Western Ontario, Department of Medicine, London, ON, Canada.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jairath', 'Affiliation': 'University of Western Ontario, Department of Medicine, London, ON, Canada.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012381.pub2']
523,32303829,Dietary nitrate does not acutely enhance skeletal muscle blood flow and vasodilation in the lower limbs of older adults during single-limb exercise.,"PURPOSE


Blood flow (BF) and vasodilator responses to knee-extension exercise are attenuated in older adults across an exercise transient (onset, kinetics, and steady-state), and reduced nitric oxide bioavailability (NO) has been hypothesized to be a primary mechanism contributing to this attenuation. We tested the hypothesis acute dietary nitrate (NO 3 - ) supplementation (~ 4.03 mmol NO 3 -  and 0.29 mmol NO 2 - ) would improve leg vasodilator responses across an exercise transient during lower limb exercise in older adults.
METHODS


Older (n = 10) untrained adults performed single and rhythmic knee-extension contractions at 20% and 40% work-rate maximum (WR max ) prior to and 2-h after consuming a NO 3 -  or placebo beverage in a double-blind, randomized fashion. Femoral artery BF was measured by Doppler ultrasound. Vascular conductance was calculated using BF and mean arterial pressure.
RESULTS


Acute ingestion of dietary NO 3 -  enhanced plasma [NO 3 - ] and [NO 2 - ] (P < 0.05). Neither dietary NO 3 -  or placebo enhanced vasodilator responses at the onset of exercise or during steady state at 20% and 40% WR max  (P > 0.05). Leg vasodilator kinetics during rhythmic exercise remained unchanged following NO 3 -  and placebo ingestion (P > 0.05).
CONCLUSIONS


The key findings of this study are that despite increasing plasma [NO 3 - ] and [NO 2 - ] ,  acute dietary NO 3 -  intake had no effect on (1) rapid hyperaemic or vasodilator responses at the onset of exercise; (2) hyperaemic and vasodilator responses during steady-state submaximal exercise; or (3) kinetics of vasodilation preceding steady-state responses. Collectively, these findings suggest that low dose dietary NO 3 -  supplementation does not improve hyperaemic and vasodilator responses across an exercise transient in older adults.",2020,"Leg vasodilator kinetics during rhythmic exercise remained unchanged following NO 3 -  and placebo ingestion (P > 0.05).
","['10) untrained adults performed', 'older adults', 'Older (n\u2009']","['Dietary nitrate', 'single and rhythmic knee-extension contractions at 20% and 40% work-rate maximum (WR max ) prior to and 2-h after consuming a NO 3 -  or placebo beverage', 'hypothesis acute dietary nitrate (NO 3 - ) supplementation (~\u20094.03\xa0mmol NO', 'placebo']","['vasodilator responses', 'Vascular conductance', 'Leg vasodilator kinetics during rhythmic exercise', 'Femoral artery BF', 'hyperaemic and vasodilator responses', 'leg vasodilator responses']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439190', 'cui_str': 'mmol'}]","[{'cui': 'C0042402', 'cui_str': 'Vasodilator agent'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.140591,"Leg vasodilator kinetics during rhythmic exercise remained unchanged following NO 3 -  and placebo ingestion (P > 0.05).
","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Hughes', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, Carver College of Medicine, University of Iowa, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Nicholas T', 'Initials': 'NT', 'LastName': 'Kruse', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, Carver College of Medicine, University of Iowa, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Ueda', 'Affiliation': 'Department of Anesthesia, Carver College of Medicine, University of Iowa, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Feider', 'Affiliation': 'Department of Anesthesia, Carver College of Medicine, University of Iowa, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hanada', 'Affiliation': 'Department of Anesthesia, Carver College of Medicine, University of Iowa, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Bock', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, Carver College of Medicine, University of Iowa, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Darren P', 'Initials': 'DP', 'LastName': 'Casey', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, Carver College of Medicine, University of Iowa, Iowa City, IA, 52242, USA. darren-casey@uiowa.edu.'}]",European journal of applied physiology,['10.1007/s00421-020-04368-8']
524,31862032,Being watched over by a conversation robot may enhance safety in simulated driving.,"INTRODUCTION


In an aging society that is more and more information-oriented, being able to replace human passengers' protective effects on vehicle drivers with those of social robots is both essential and promising. However, the effects of a social robot's presence on drivers have not yet been fully explored. Thus, using a driving simulator and a conversation robot, this experimental study had two main goals: (a) to find out whether social robots' anthropomorphic qualities (i.e., not the practical information the robot provides drivers) have protective effects by promoting attentive driving and alleviating crash risks; and (b) by what psychological processes such effects emerge.
METHOD


Participants were recruited from young (n = 38), the middle-aged (n = 39), and the elderly (n = 49) age groups. They were assigned to either the treatment group (simulated driving in a conversation robot's presence) or the control group (simulated driving alone), and their driving performance was measured. Mental states (peaceful, concentrating, and reflective) also were assessed in a post-driving questionnaire using our original scales.
RESULTS


Although the group of older participants did not experience protective effects (perhaps due to motion sickness), the young participants drove attentively, with the robot enhancing peace of mind. The protective effect was also observed among the middle-aged participants, and the verbal data analysis ascribed this to the robot's role of expressing sympathy, especially when the middle-aged drivers nearly had not-at-fault crashes, which caused them to be stressed. In conclusion, we discuss the practical implications of the results.",2019,"They were assigned to either the treatment group (simulated driving in a conversation robot's presence) or the control group (simulated driving alone), and their driving performance was measured.","['Participants were recruited from young (n\u202f=\u202f38), the middle-aged (n\u202f=\u202f39), and the elderly (n\u202f=\u202f49) age groups']","[""treatment group (simulated driving in a conversation robot's presence) or the control group (simulated driving alone""]","['Mental states (peaceful, concentrating, and reflective', 'protective effect']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0166334,"They were assigned to either the treatment group (simulated driving in a conversation robot's presence) or the control group (simulated driving alone), and their driving performance was measured.","[{'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Management, Kochi University of Technology, 185 Miyanokuchi, Kami City, Kochi Prefecture, Japan. Electronic address: nakagawa.yoshinori@kochi-tech.ac.jp.'}, {'ForeName': 'Kaechang', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Research Organization for Regional Alliance, Kochi University of Technology, 185 Miyanokuchi, Kami City, Kochi Prefecture, Japan.'}, {'ForeName': 'Hirotada', 'Initials': 'H', 'LastName': 'Ueda', 'Affiliation': 'Research Organization for Regional Alliance, Kochi University of Technology, 185 Miyanokuchi, Kami City, Kochi Prefecture, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ono', 'Affiliation': 'Honda Motor Co., Ltd., 1-10-1 Shin Sayama, Sayama City, Saitama Prefecture, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Miyake', 'Affiliation': 'Nissho Electronics Corporation, 3-5, Nibancho, Chiyoda-ku, Tokyo, Japan.'}]",Journal of safety research,['10.1016/j.jsr.2019.09.010']
525,31599994,The impact of high-intensity interval training on ventricular remodeling in patients with a recent acute myocardial infarction-A randomized training intervention pilot study.,"BACKGROUND


Aerobic exercise training is associated with beneficial ventricular remodeling and an improvement in cardiac biomarkers in chronic stable heart failure. High-intensity interval training (HIIT) is a time-efficient method to improve  V   ˙   O   2   peak      in stable coronary heart disease patients. This pilot study aimed to compare the effect of HIIT on ventricular remodeling in patients with a recent acute myocardial infarction (AMI).
METHODS


Nineteen post-AMI patients were randomized to either HIIT (n = 9) or usual care (n = 10). A cardiopulmonary exercise test (CPET), transthoracic echocardiography, and cardiac biomarker assessment (ie, N-terminal pro B-type natriuretic peptide levels and G protein-coupled receptor kinase 2 expression) were performed before and after a 12-week training intervention. CPET parameters including oxygen uptake efficiency slope (OUES) and  V   ˙   O   2    at the first ventilatory threshold (  V   ˙   O   2    VT1) were calculated. left ventricular (LV) structural and functional echocardiographic parameters including myocardial strain imaging were assessed.
RESULTS


V   ˙   O   2   peak      and OUES improved solely in the HIIT group (P < .05 for group/time, respectively). There was a significant training effect for the improvement of peak work load in both groups (P < .05). O 2  pulse and  V   ˙   O   2    at VT1 both improved only in the HIIT group (P < .05 for time, no interaction). HIIT improved radial strain and pulsed-wave tissue Doppler imaging derived e' (P < .05 for time, no interaction). Cardiac biomarkers did not change in either group.
CONCLUSIONS


In post-AMI patients, HIIT lead to significant improvements in prognostic CPET parameters compared to usual care. HIIT was associated with favorable ventricular remodeling regarding certain echocardiographic parameters of LV function.",2019,"˙   O   2   peak      and OUES improved solely in the HIIT group (P < .05 for group/time, respectively).","['patients with a recent acute myocardial infarction (AMI', 'stable coronary heart disease patients', 'Nineteen post-AMI patients', 'chronic stable heart failure', 'patients with a recent acute myocardial infarction']","['high-intensity interval training', 'O 2  pulse and  V', 'HIIT', 'Aerobic exercise training', 'cardiopulmonary exercise test (CPET), transthoracic echocardiography, and cardiac biomarker assessment', 'usual care', 'High-intensity interval training (HIIT']","['Cardiac biomarkers', 'HIIT improved radial strain and pulsed-wave tissue Doppler imaging derived e', 'peak work load', 'left ventricular (LV) structural and functional echocardiographic parameters including myocardial strain imaging', 'oxygen uptake efficiency slope (OUES) and  V', '˙   O   2   peak      and OUES', 'prognostic CPET parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography (procedure)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1868749', 'cui_str': 'Myocardial strain'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0055954', 'cui_str': 'CPET'}]",19.0,0.0149877,"˙   O   2   peak      and OUES improved solely in the HIIT group (P < .05 for group/time, respectively).","[{'ForeName': 'Lukas-Daniel', 'Initials': 'LD', 'LastName': 'Trachsel', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (ÉPIC) Center, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Louis-Philippe', 'Initials': 'LP', 'LastName': 'David', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Gayda', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (ÉPIC) Center, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Henri', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hayami', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (ÉPIC) Center, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Thorin-Trescases', 'Affiliation': 'Research Center, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Thorin', 'Affiliation': 'Research Center, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Mélissa-Anne', 'Initials': 'MA', 'LastName': 'Blain', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (ÉPIC) Center, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Mariève', 'Initials': 'M', 'LastName': 'Cossette', 'Affiliation': 'Montreal Health Innovations Coordinating Center, Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lalongé', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (ÉPIC) Center, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Juneau', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (ÉPIC) Center, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Nigam', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation (ÉPIC) Center, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}]",Clinical cardiology,['10.1002/clc.23277']
526,30683803,Impact of a youth-led social marketing intervention run by adolescents to encourage healthy lifestyles among younger school peers (EYTO-Kids project): a parallel-cluster randomised controlled pilot study.,"BACKGROUND


Encouraging healthy lifestyles in children is a challenge. This project aimed to improve lifestyles of younger peers by engaging adolescent creators (ACs) to design and implement peer-led and social marketing (SM) health-promoting activities.
METHODS


A 10-month parallel-cluster randomised controlled school-based pilot study was performed in disadvantaged neighbourhoods in Reus (Spain) spanning two academic years (2015-2016/2016-2017). Eight primary schools (n=375 children) and four high schools (n=94ACs) were randomly placed in the intervention group. The 94 ACs (12-14 years) designed and implemented four SM activities for their younger peers (9-11 years). Eight primary schools (n=327 children) and three high schools (n=98 adolescents) served as the control group and received no intervention. Primary (physical activity and fruit consumption) and secondary outcomes (screen time, vegetables, soft drinks, sweets and fast food consumptions) were assessed with validated questionnaires at baseline and at the end of the study.
RESULTS


After 10 months, fruit consumption and physical activity were maintained in the children who consumed ≥1 fruit/day and spent ≥6 hours/week physical activity. However, compared with the controls, the intervention significantly increased the physical activity of girls to 15.6 min/week, whereas the percentage of girls who consumed sweets, soft drinks and fast food decreased significantly by 8.4%, 14.5% and 5.9%, respectively. Additionally, the percentage of ≥2 hour/weekday of screen time by boys decreased significantly by 8.2%.
CONCLUSION


The European Youth Tackling Obesity-Kids, SM and peer-led intervention, effectively increased physical activity hours/week in girls, but was not effective in improving the percentage of children who consumed the recommended fruit. Moreover, the percentages of girls who consumed sweets, soft drinks and fast food and boys screen time decreased.
TRIAL REGISTRATION NUMBER


NCT02702336; Pre-results.",2019,"However, compared with the controls, the intervention significantly increased the physical activity of girls to 15.6 min/week, whereas the percentage of girls who consumed sweets, soft drinks and fast food decreased significantly by 8.4%, 14.5% and 5.9%, respectively.","['disadvantaged neighbourhoods in Reus (Spain) spanning two academic years (2015-2016/2016-2017', 'Eight primary schools (n=375 children) and four high schools (n=94ACs', 'younger school peers (EYTO-Kids project', 'Eight primary schools (n=327 children) and three high schools (n=98 adolescents', 'younger peers by engaging adolescent creators (ACs']","['youth-led social marketing intervention', 'control group and received no intervention']","['percentages of girls who consumed sweets, soft drinks and fast food and boys screen time decreased', 'percentage of ≥2\u2009hour/weekday of screen time', 'fruit consumption and physical activity', 'physical activity', 'Primary (physical activity and fruit consumption) and secondary outcomes (screen time, vegetables, soft drinks, sweets and fast food consumptions']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C3489624', 'cui_str': 'Soft Drinks'}, {'cui': 'C0344355', 'cui_str': 'Convenience Foods'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]",,0.0184278,"However, compared with the controls, the intervention significantly increased the physical activity of girls to 15.6 min/week, whereas the percentage of girls who consumed sweets, soft drinks and fast food decreased significantly by 8.4%, 14.5% and 5.9%, respectively.","[{'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Tarro', 'Affiliation': 'Medicine and Surgery and Basical Medical Sciences, Universitat Rovira i Virgili, Facultat de Medicina i Ciències de la Salut, Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Health Education and Promotion, C/ Sant Llorenç, 21, Reus (43201), Spain, Reus, Spain.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Llauradó', 'Affiliation': 'Medicine and Surgery and Basical Medical Sciences, Universitat Rovira i Virgili, Facultat de Medicina i Ciències de la Salut, Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Health Education and Promotion, C/ Sant Llorenç, 21, Reus (43201), Spain, Reus, Spain.'}, {'ForeName': 'Magaly', 'Initials': 'M', 'LastName': 'Aceves-Martins', 'Affiliation': 'Medicine and Surgery and Basical Medical Sciences, Universitat Rovira i Virgili, Facultat de Medicina i Ciències de la Salut, Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Health Education and Promotion, C/ Sant Llorenç, 21, Reus (43201), Spain, Reus, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moriña', 'Affiliation': ""Infections and Cancer-Information and Interventions, Unit of Infections and Cancer-Information and Interventions (UNIC-I&I), Catalan Institute of Oncology (ICO)-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain.""}, {'ForeName': 'Ignasi', 'Initials': 'I', 'LastName': 'Papell-Garcia', 'Affiliation': 'Health and Nutrition, Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Avinguda Universitat 1, Reus, Catalonia, Spain.'}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Arola', 'Affiliation': 'Health and Nutrition, Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Avinguda Universitat 1, Reus, Catalonia, Spain.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Giralt', 'Affiliation': 'Medicine and Surgery and Basical Medical Sciences, Universitat Rovira i Virgili, Facultat de Medicina i Ciències de la Salut, Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Health Education and Promotion, C/ Sant Llorenç, 21, Reus (43201), Spain, Reus, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Solà', 'Affiliation': 'Medicine and Surgery and Basical Medical Sciences, Universitat Rovira i Virgili, Facultat de Medicina i Ciències de la Salut, Functional Nutrition, Oxidation, and Cardiovascular Diseases Group (NFOC-Salut), Health Education and Promotion, C/ Sant Llorenç, 21, Reus (43201), Spain, Reus, Spain.'}]",Journal of epidemiology and community health,['10.1136/jech-2017-210163']
527,32164441,Adjuvant Single-Dose Upper Urinary Tract Instillation of Mitomycin C After Therapeutic Ureteroscopy for Upper Tract Urothelial Carcinoma: A Single-Centre Prospective Non-Randomized Trial.,"Purpose:  To address the safety and feasibility of adjuvant single-dose upper urinary tract instillation of mitomycin (ASDM) immediately after therapeutic ureteroscopy for upper tract urothelial carcinoma (UTUC) and to compare urothelial (ipsilateral or bladder) recurrence rates in the ASDM group and controls.  Materials and Methods:  Between April 2015 and August 2018, 52 patients affected by UTUC were treated by endoscopic ablation, of whom 26 were selected for ASDM. Clinical and perioperative data and 30-day complications were recorded. Urothelial recurrence-free survival (URFS) was evaluated with second-look ureteroscopy (URS) and CT scan/URS every 6 months.  Results:  ASDM was administered through a Single-J (19/25, 76%) or a Double-J (6/25, 24%) in 25/26 (96%) patients. Median follow-up was 18 months (IQR 10-29). The urothelial recurrence rate was 23.5% and 55.5% in the ASDM group and controls, respectively ( p  = 0.086). Mean URFS was 28.8 months in the ASDM group  vs  18.8 months in controls (log-rank  p  = 0.067). On multivariate Cox regression, ASDM was associated with a 7.7-fold lower risk of urothelial recurrence (HR = 0.13; 95% CI 0.03-0.65;  p  = 0.01). Clavien grade ≤II complications occurred in 32% (8/25) and 30.7% (8/26) of the ASDM and control group, respectively ( p  = 0.9). Two Clavien III complications occurred in the ASDM group: bladder hematuria after concomitant transurethral resection of bladder and obstructive kidney failure in a single-kidney patient.  Conclusions:  ASDM was well tolerated after therapeutic URS. It appears to reduce the risk of urothelial recurrence in patients affected by low-grade UTUC without bladder tumor. Therefore, its use should be evaluated.",2020,Two Clavien III complications occurred in the ASDM group: bladder haematuria after concomitant TURB and obstructive kidney failure in a single-kidney patient.,"['upper tract urothelial carcinoma', 'upper tract urothelial carcinoma (UTUC', 'Materials and Methods Between April 2015 and August 2018, 52 patients affected by UTUC were treated by endoscopic ablation, of whom 26 were selected for ASDM']","['Adjuvant single-dose upper urinary tract instillation of mitomycin C', 'mitomycin (ASDM', 'ASDM']","['obstructive kidney failure', 'Clavien grade ≤II complications', 'urothelial recurrence-free survival (URFS) evaluated by second-look ureteroscopy and CT scan/ureteroscopy every 6 months', 'urothelial recurrence rate', 'urothelial (ipsilateral or bladder) recurrence rates', 'urothelial recurrence', 'Clinical and perioperative data and 30-day complications', 'risk of urothelial recurrence', 'Mean URFS']","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0042027'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0585339', 'cui_str': 'q6mo'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",52.0,0.0631059,Two Clavien III complications occurred in the ASDM group: bladder haematuria after concomitant TURB and obstructive kidney failure in a single-kidney patient.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gallioli', 'Affiliation': 'Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Boissier', 'Affiliation': 'Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Territo', 'Affiliation': 'Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Vila Reyes', 'Affiliation': 'Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sanguedolce', 'Affiliation': 'Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'José Maria', 'Initials': 'JM', 'LastName': 'Gaya', 'Affiliation': 'Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Regis', 'Affiliation': 'Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'José Daniel', 'Initials': 'JD', 'LastName': 'Subiela', 'Affiliation': 'Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Palou', 'Affiliation': 'Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Breda', 'Affiliation': 'Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain.'}]",Journal of endourology,['10.1089/end.2019.0750']
528,31631248,Prospective randomized trial comparing efficacy of letrozole step-up protocol with letrozole plus gonadotropins for controlled ovarian stimulation and intrauterine insemination in patients with unexplained infertility.,"PURPOSE


Empirical treatment options for unexplained infertility treatment include controlled ovarian stimulation (COS) with clomiphene citrate, letrozole or gonadotropins followed by intrauterine insemination (IUI). Achieving consistent multifollicular development with letrozole generally requires addition of gonadotropins. However, the cost and discomfort of injections remains a drawback of this regimen. Therefore, there is a need for evolving newer cost-effective regimens for COS/IUI using orally administered drugs like letrozole.
METHODS


Sixty couples with unexplained infertility (on standard infertility investigations) visiting the infertility clinic at a tertiary centre in North India were randomized into two groups. Group A COS was done by step-up protocol of letrozole from day 2 or 3 of menstrual cycle, starting with 2.5 mg and increased by 2.5 mg per day for next 3 days (2.5 mg, 5 mg, 7.5 mg, 10 mg). Group B COS was done with combination of letrozole and hMG (human menopausal gonadotropin). Starting from day 2 or 3 of menses, tablet letrozole 2.5 mg twice a day was given for 5 days. Intramuscular injection of hMG 150 IU was given every alternate day starting from day 7 and titrated according to the response. HCG was given when leading follicle was 17 mm and IUI done 36 h after HCG.
RESULTS


Twenty-eight couples in letrozole step-up group (group A) and 30 couples in letrozole plus hMG group (group B), completed follow up for 44 and 55 cycles, respectively. Mean numbers of follicle ≥ 16 mm in both groups were comparable: 1.74 (± 0.83) in group A and 1.94 (± 0.68) in group B (p = 0.178). Ovulation rate of 90.9% (40/44) was achieved in group A, whereas it was 100% (55/55) in group B (p = 0.022), although there was no significant difference in clinical pregnancy rate per patient, which was 3/28 (10.7%) in group A versus 5/30 (16.67%) in group B (p = 0.707). The mean (SD) cost of medicines was significantly lower in group A Rs. 345.00 (00) compared to group B Rs. 2148.64 (515.67) [p < 0.0001]. There was one case each of hyperstimulation and multiple pregnancies in group B, while none in group A.
CONCLUSION


It is possible to achieve multifollicular development with use of novel letrozole step-up protocol, even without addition of gonadotropins, at significantly lower cost.",2019,"Ovulation rate of 90.9% (40/44) was achieved in group A, whereas it was 100% (55/55) in group B (p = 0.022), although there was no significant difference in clinical pregnancy rate per patient, which was 3/28 (10.7%) in group A versus 5/30 (16.67%) in group B (p = 0.707).","['Sixty couples with unexplained infertility (on standard infertility investigations) visiting the infertility clinic at a tertiary centre in North India', 'patients with unexplained infertility', 'Twenty-eight couples in']","['letrozole', 'letrozole and hMG (human menopausal gonadotropin', 'letrozole step-up protocol with letrozole plus gonadotropins', 'letrozole plus hMG', 'HCG', 'clomiphene citrate, letrozole or gonadotropins followed by intrauterine insemination (IUI', 'hMG']","['Ovulation rate', 'clinical pregnancy rate', 'Mean numbers of follicle\u2009≥', 'mean (SD) cost of medicines']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3715200', 'cui_str': 'Infertility clinic'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}, {'cui': 'C0454366', 'cui_str': 'Step ups (regime/therapy)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}]","[{'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]",60.0,0.0692462,"Ovulation rate of 90.9% (40/44) was achieved in group A, whereas it was 100% (55/55) in group B (p = 0.022), although there was no significant difference in clinical pregnancy rate per patient, which was 3/28 (10.7%) in group A versus 5/30 (16.67%) in group B (p = 0.707).","[{'ForeName': 'Japleen', 'Initials': 'J', 'LastName': 'Kaur', 'Affiliation': 'Department of Obstetrics and Gynecology, Nehru Hospital, Postgraduate Institute of Medical Education and Research (PGIMER), 3rd Floor, Chandigarh, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Suri', 'Affiliation': 'Department of Obstetrics and Gynecology, Nehru Hospital, Postgraduate Institute of Medical Education and Research (PGIMER), 3rd Floor, Chandigarh, India.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Gainder', 'Affiliation': 'Department of Obstetrics and Gynecology, Nehru Hospital, Postgraduate Institute of Medical Education and Research (PGIMER), 3rd Floor, Chandigarh, India.'}, {'ForeName': 'Aashima', 'Initials': 'A', 'LastName': 'Arora', 'Affiliation': 'Department of Obstetrics and Gynecology, Nehru Hospital, Postgraduate Institute of Medical Education and Research (PGIMER), 3rd Floor, Chandigarh, India. aashicool84@gmail.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05326-2']
529,30980618,A cream of herbal mixture to improve melasma.,"BACKGROUND


Melasma is an acquired, common hyperpigmented disorder on the face. While many therapeutic approaches are available, their efficacy is moderate.
OBJECTIVE


To investigate the safety and efficacy of a cream containing herbal mixture for melasma.
METHODS


A total of 90 volunteers with melasma were enrolled in this randomized, double-blind, controlled clinical study, and they were randomly divided into three groups (A, B, and C). Patients in group A were treated with a cream containing herbal mixture, while groups B and C were treated with arbutin cream and placebo, respectively, twice daily for 12 weeks. Melasma area and severity index (MASI) score, melanin index (MI), erythema index (EI), changes in density of inflammatory cells, and adverse events were evaluated every 4 weeks.
RESULTS


Although MASI scores declined significantly in both groups A and B (P < 0.05), a greater reduction was seen in group A (13.00-9.82 = 3.18 for group A; 12.65-10.84 = 1.81 for group B). Moreover, the cream containing herbal mixture, but not arbutin cream and placebo, significantly reduced EI and density of inflammatory cells after 12-week treatment (P < 0.05). No adverse reactions were observed in either group A or group C. In group B, two subjects experienced mild erythema and itching, which disappeared after stop using the arbutin cream.
CONCLUSION


The cream containing herbal mixture is safe and effective for melasma.",2019,No adverse reactions were observed in either group A or group,['90 volunteers with melasma'],"['cream containing herbal mixture', 'arbutin cream and placebo', 'placebo', 'herbal mixture']","['Melasma area and severity index (MASI) score, melanin index (MI), erythema index (EI), changes in density of inflammatory cells, and adverse events', 'reduced EI and density of inflammatory cells', 'safety and efficacy', 'melasma', 'MASI scores', 'mild erythema and itching', 'adverse reactions']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0003729', 'cui_str': 'Arbutin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",90.0,0.0434724,No adverse reactions were observed in either group A or group,"[{'ForeName': 'Qiongyu', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': 'Department of Dermatology, First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Department of Dermatology, First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Dongjie', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Dermatology, First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Dermatology, First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Mao-Qiang', 'Initials': 'MQ', 'LastName': 'Man', 'Affiliation': 'Dermatology Service, Veterans Affairs Medical Center San Francisco, San Francisco, California.'}, {'ForeName': 'Hongduo', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Haiyang', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Phytochemistry and Plant Resources in West China, Kunming Institute of Botany, Chinese Academy of Sciences, Kunming, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Beitaini Bio-technological Co Ltd, Kunming, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Dermatology, First Affiliated Hospital of Kunming Medical University, Kunming, China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.12938']
530,32229581,Antidopaminergic treatment is associated with reduced chorea and irritability but impaired cognition in Huntington's disease (Enroll-HD).,"OBJECTIVES


Alterations in dopamine neurotransmission underlie some of the clinical features of Huntington's disease (HD) and as such are a target for therapeutic intervention, especially for the treatment of chorea and some behavioural problems. However, justification for such an intervention is mainly based on case reports and small open label studies and the effects these drugs have on cognition in HD remain unclear.
METHODS


In this study, we used the Enroll-HD observational database to assess the effects of antidopaminergic medication on motor, psychiatric and cognitive decline, over a 3-year period. We first looked at the annual rate of decline of a group of HD patients taking antidopaminergic medication (n=466) compared with an untreated matched group (n=466). The groups were matched on specified clinical variables using propensity score matching. Next, we studied a separate group of HD patients who were prescribed such medications part way through the study (n=90) and compared their rate of change before and after the drugs were introduced and compared this to a matched control group.
RESULTS


We found that HD patients taking antidopaminergic medication had a slower progression in chorea and irritability compared with those not taking such medications. However, this same group of patients also displayed significantly greater rate of decline in a range of cognitive tasks.
CONCLUSION


In conclusion we found that antidopaminergic treatment is associated with improvements in the choreic movements and irritability of HD but worsens cognition. However, further research is required to prospectively investigate this and whether these are causally linked, ideally in a double-blind placebo-controlled trial.",2020,In conclusion we found that antidopaminergic treatment is associated with improvements in the choreic movements and irritability of HD but worsens cognition.,"['HD patients taking antidopaminergic medication (n=466) compared with an untreated matched group (n=466', 'HD patients who were prescribed such medications part way through the study (n=90']","['antidopaminergic medication', 'Antidopaminergic']","['chorea and irritability', 'choreic movements and irritability of HD but worsens cognition', 'motor, psychiatric and cognitive decline']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0008489', 'cui_str': 'Choreatic Syndromes'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}]",,0.0291193,In conclusion we found that antidopaminergic treatment is associated with improvements in the choreic movements and irritability of HD but worsens cognition.,"[{'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Harris', 'Affiliation': 'Department of Clinical Neurosciences, The University of Cambridge, Cambridge, United Kingdom kh600@cam.ac.uk.'}, {'ForeName': 'Wei-Li', 'Initials': 'WL', 'LastName': 'Kuan', 'Affiliation': 'Department of Clinical Neurosciences, The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Mason', 'Affiliation': 'Department of Clinical Neurosciences, Cambridge Centre for Brain Repair, Cambridge, Cambridgeshire, United Kingdom.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Barker', 'Affiliation': 'Department of Clinical Neurosciences, John van Geest Centre for Brain Repair, and MRC-WT Cambridge Stem Cell Institute, University of Cambridge, Cambridge, United Kingdom.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-322038']
531,32239737,"Meralgia paresthetica: Nerve stimulator-guided injection with methylprednisolone/lidocaine, a double-blind randomized placebo-controlled study.","BACKGROUND


Meralgia paresthetica is a mononeuropathy of the lateral femoral cutaneous nerve. A common therapy is injection with corticosteroids. The goal of this study was to analyze the effect of injection with methylprednisolone/lidocaine vs placebo.
METHODS


After randomization, 10 patients received a nerve stimulator-guided injection with methylprednisolone/lidocaine, and 10 patients received saline. The primary outcome measure was pain (visual analogue scale, VAS).
RESULTS


In the placebo group, there was a significant pain reduction (baseline VAS, 6.8; VAS week 12, 4.3; P = .014). The VAS score in the methylprednisolone group did not show a significant reduction (baseline VAS, 7.4; VAS week 12, 4.8; P = .053). There was no significant difference in pain reduction between the groups.
CONCLUSIONS


We found no objective evidence for benefit from nerve stimulator-guided injection with corticosteroids in meralgia paresthetica, although this study is limited by a small sample size. Future placebo-controlled studies using ultrasound-guided injection are warranted.",2020,"We found no objective evidence for benefit from nerve stimulator-guided injection with corticosteroids in meralgia paraesthetica, although this study is limited by a small sample size.",[],"['methylprednisolone', 'placebo', 'methylprednisolone/lidocaine', 'saline', 'nerve stimulator-guided injection with methylprednisolone/lidocaine']","['VAS score', 'pain (visual analogue scale, VAS', 'pain reduction']",[],"[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0582124', 'cui_str': 'Neurostimulator'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.599475,"We found no objective evidence for benefit from nerve stimulator-guided injection with corticosteroids in meralgia paraesthetica, although this study is limited by a small sample size.","[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Kloosterziel', 'Affiliation': 'Department of Neurology, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Dénes L J', 'Initials': 'DLJ', 'LastName': 'Tavy', 'Affiliation': 'Department of Neurology, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Arends', 'Affiliation': 'Department of Neurology, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Joyce M', 'Initials': 'JM', 'LastName': 'Zijdewind', 'Affiliation': 'Department of Neurology, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Erik W', 'Initials': 'EW', 'LastName': 'van Zwet', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Wirtz', 'Affiliation': 'Department of Neurology, Haga Hospital, The Hague, The Netherlands.'}]",Muscle & nerve,['10.1002/mus.26877']
532,31686184,Efficacy and safety of two post-operative drains: results of a prospectively randomized clinical study in breast cancer patients after breast conserving surgery.,"OBJECTIVE


To compare the efficacy and safety of two post-operative drains in breast cancer patients after breast conserving surgery.
METHODS


This was a prospectively randomized comparative study of two drains investigated in breast cancer patients after breast conserving therapy. The Redon drain ends in a tip with 28 double perforations while the Quadrain drain features 4 flexible flaps of about 0.15 m length. The drains cost 0.28 € and 3.54 €, respectively. Primary target parameter was the duration of the drains staying in the surgical site. Secondary target parameters were pain post-surgery, seroma volume, final cosmetic result and surgical site infections.
RESULTS


A total of 88 patients were randomized, 47 and 41 received the Redon drain and the Quadrain drain, respectively. The mean duration of the drains staying in the surgical site was not different between the Redon and the Quadrain drain, 42.6 h (± 25.8 h) and 50.1 h (± 28.5 h), respectively (p = 0.1959). The post-operative pain score, seroma size, cosmetic result and surgical site infections were not different for both systems.
CONCLUSION


The Redon drain and the new Quadrain drain were not significantly different with respect to duration in the surgical site, post-operative pain, seroma volume and cosmetic result.",2019,"The post-operative pain score, seroma size, cosmetic result and surgical site infections were not different for both systems.
","['breast cancer patients after breast conserving therapy', 'breast cancer patients after breast conserving surgery', '88 patients were randomized, 47 and 41 received the']","['two post-operative drains', 'Redon drain and the Quadrain drain']","['post-operative pain score, seroma size, cosmetic result and surgical site infections', 'efficacy and safety', 'Efficacy and safety', 'pain post-surgery, seroma volume, final cosmetic result and surgical site infections', 'duration of the drains staying', 'mean duration of the drains staying']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",88.0,0.0672633,"The post-operative pain score, seroma size, cosmetic result and surgical site infections were not different for both systems.
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schmidt', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Kirrberger Straße, 66421, Homburg/Saar, Germany. gilda.schmidt@uks.eu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zuschlag', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Kirrberger Straße, 66421, Homburg/Saar, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gerlinger', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Kirrberger Straße, 66421, Homburg/Saar, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Endrikat', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Kirrberger Straße, 66421, Homburg/Saar, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Müller', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Kirrberger Straße, 66421, Homburg/Saar, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gabriel', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Kirrberger Straße, 66421, Homburg/Saar, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ströder', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Kirrberger Straße, 66421, Homburg/Saar, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Juhasz-Böss', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Kirrberger Straße, 66421, Homburg/Saar, Germany.'}, {'ForeName': 'E F', 'Initials': 'EF', 'LastName': 'Solomayer', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Kirrberger Straße, 66421, Homburg/Saar, Germany.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05360-0']
533,31823503,A qualitative analysis of text message conversations in a breastfeeding peer counselling intervention.,"The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) breastfeeding peer counselling (BFPC) program supports optimal early life nutrition by providing evidenced-based breastfeeding protection, promotion, and support. The Lactation Advice Through Texting Can Help (LATCH) study was a randomized controlled trial that tested the effectiveness of a text messaging intervention designed to augment the BFPC program. The purpose of the present study was to understand the topics discussed during the text message exchanges between breastfeeding peer counsellors (PCs) and their clients in the intervention arm of the LATCH study, from the time of enrollment up to two-weeks postpartum. Text messaging data were first coded and analysed for one- and two-way text message exchanges. Text messages of participants with a high volume of two-way exchanges were then analysed qualitatively. Four domains were identified in both the prenatal and postpartum periods: the mechanics of breastfeeding, social support, baby's nutrition, and PCs maintaining contact with participants. Additional themes and subthemes identified in the postpartum period included the discussion of breastfeeding problems such as latching trouble engorgement, plugged ducts, pumping, other breastfeeding complications, and resuming breastfeeding if stopped. Two-way text messaging in the context of the WIC BFPC program provides an immediate and effective method of substantive communication between mothers and their PC.",2020,"Four domains were identified in both the prenatal and postpartum periods: the mechanics of breastfeeding, social support, baby's nutrition, and PCs maintaining contact with participants.","['participants with a high volume of two-way exchanges', 'Women, Infants and Children (WIC']","['breastfeeding peer counselling (BFPC) program', 'text messaging intervention']","['discussion of breastfeeding problems such as latching trouble engorgement, plugged ducts, pumping, other breastfeeding complications, and resuming breastfeeding if stopped']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0687028', 'cui_str': 'Duct (organ) structure'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]",,0.0315317,"Four domains were identified in both the prenatal and postpartum periods: the mechanics of breastfeeding, social support, baby's nutrition, and PCs maintaining contact with participants.","[{'ForeName': 'Josefa L', 'Initials': 'JL', 'LastName': 'Martinez-Brockman', 'Affiliation': 'Department of General Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Nurit', 'Initials': 'N', 'LastName': 'Harari', 'Affiliation': 'Chinle Comprehensive Health Care Facility, Indian Health Service, Chinle, Arizona.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Goeschel', 'Affiliation': 'Connecticut Special Supplemental Nutrition Program for Women, Infants, and Children, Community, Family and Health Equity Section, Connecticut Department of Public Health, Hartford, Connecticut.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Bozzi', 'Affiliation': 'Breastfeeding Heritage and Pride Program, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Pérez-Escamilla', 'Affiliation': 'Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, Connecticut.'}]",Maternal & child nutrition,['10.1111/mcn.12904']
534,32179929,Rehabilitation in warm climate for young adults with inflammatory arthritis: A 12-month randomized controlled trial.,"OBJECTIVES


To investigate if an intensive rehabilitation programme, including intensive exercise and patient education, for young adults with inflammatory arthritis, conducted in a warm climate, has long-term effects on general health status compared with usual care.
DESIGN


Open randomized controlled trial.
PATIENTS


A total of 64 patients with inflammatory arthritis, aged 20-35 years.
METHODS


Patients underwent randomized allocation to an intensive 17-day rehabilitation programme in a warm climate (intervention group) or to usual care with no structured rehabilitation (control group). The primary outcomes were physical function, assessed by the ""30-second Sit to Stand test""(30sSTS), and coping, measured by the ""Effective Musculoskeletal Consumer Scale"" (EC17).
RESULTS


A total of 64 patients (mean age 27.5 years, 62.5% female) were randomized. Thirty out of 32 patients completed the intervention. At 12-month follow-up, 7 patients were lost to follow-up; 4 from the intervention group and 3 from the control group. The intervention group showed significant improvement in the physical function test at 3 months; estimated mean difference (95% confidence interval): 5.5 (2.8-8.1), 6 months 3.6 (0.4-6.8) and 12 months 4.0 (0.0-7.9), compared with the control group. There were no differences in coping between the 2 groups at 3, 6 or 12 months.
CONCLUSION


Rehabilitation in a warm climate improves physical functioning, but not coping, in young adults with inflammatory arthritis.",2020,"The intervention group showed significant improvement in the physical function test at 3 months; estimated mean difference (95% confidence interval): 5.5 (2.8-8.1), 6 months 3.6 (0.4-6.8) and 12 months 4.0 (0.0-7.9), compared with the control group.","['64 patients (mean age 27.5 years, 62.5% female', 'Thirty out of 32 patients completed the intervention', '64 patients with inflammatory arthritis, aged 20-35 years', 'Patients underwent randomized allocation to an', 'young adults with RA', 'young adults with inflammatory arthritis']","['intensive 17-day rehabilitation programme in a warm climate (intervention group) or to usual care with no structured rehabilitation (control group', 'intensive rehabilitation programme', 'intensive exercise and patient education']","['physical functioning', 'physical function, assessed by the ""30-second Sit to Stand test""(30sSTS), and coping, measured by the ""Effective Musculoskeletal Consumer Scale"" (EC17', 'physical function test']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0222045'}]",64.0,0.122181,"The intervention group showed significant improvement in the physical function test at 3 months; estimated mean difference (95% confidence interval): 5.5 (2.8-8.1), 6 months 3.6 (0.4-6.8) and 12 months 4.0 (0.0-7.9), compared with the control group.","[{'ForeName': 'Ingrid Rekaa', 'Initials': 'IR', 'LastName': 'Nilssen', 'Affiliation': 'Norwegian National Advisory Unit on Pregnancy and Rheumatic diseases, Department of Rheumatology, St. Olavs hospital, Trondheim University Hospital, , 7006 Trondheim, Norway. Ingrid.Rekaa.Nilssen@stolav.no.'}, {'ForeName': 'Hege Svean', 'Initials': 'HS', 'LastName': 'Koksvik', 'Affiliation': ''}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Grønning', 'Affiliation': ''}, {'ForeName': 'Aslak', 'Initials': 'A', 'LastName': 'Steinsbekk', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2666']
535,31358922,Progression and new onset of macular retinoschisis in myopic choroidal neovascularization eyes after Conbercept therapy: a post-hoc analysis.,"OBJECTIVES


The objective of this study is to evaluate the progression and new onset of macular retinoschisis (MRS) in the patients treated with intravitreal Conbercept injections for myopic choroidal neovascularization (mCNV).
METHODS


Post-hoc analysis of 160 mCNV patients included in SHINY study was performed to evaluate the impact of Conbercept injection on MRS in patients with mCNV undergoing intravitreal Conbercept injections. The patients were 3:1 randomized to the study group (three loading dose and thereafter pro re nata [PRN]) and the control group (3 months' sham injection, then one Conbercept injection at month 4 and thereafter PRN). MRS was assessed with optical coherence tomography by masked graders.
RESULTS


At baseline, 28 of 122 eyes in study group and 10 of 38 eyes in control group had MRS. At month 3, two patients showed MRS progression and one patient had new onset MRS in study group. No MRS progression nor new onset MRS was found in the control group. At final visit, the cumulative incidence of MRS was 1.3% (2/160). Both Spearman's correlation and multiple logistic regression demonstrated no association between the progression and new onset of MRS and intravitreal injection frequency (correlation coefficient = 0.017, P = 0.851 and odds ratio = 0.996, P = 0.982). In addition, baseline vitreoretinal adhesion was the most likely potential risk factor resulting in MRS progression (odds ratio = 4.566, P = 0.027). Furthermore, MRS progression was more likely to take place in outer retinal layers.
CONCLUSIONS


The progression and new onset of MRS was not associated with the frequency of intravitreal Conbercept injections.",2020,No MRS progression nor new onset MRS was found in the control group.,"['myopic choroidal neovascularization eyes after Conbercept therapy', '160 mCNV patients included in SHINY study', 'for myopic choroidal neovascularization (mCNV', 'patients with mCNV undergoing intravitreal Conbercept injections']","['Conbercept injection on MRS', 'intravitreal Conbercept injections']","['MRS', 'cumulative incidence of MRS', 'progression and new onset of MRS and intravitreal injection frequency', 'MRS progression nor new\xa0onset MRS', 'MRS progression', 'new onset MRS']","[{'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",,0.0474506,No MRS progression nor new onset MRS was found in the control group.,"[{'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yuanzhi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Minlu', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Kuang', 'Affiliation': 'R&D Center, Chengdu Kanghong Biotech Ltd., Sichuan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Peking, China.'}, {'ForeName': 'Fenghua', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. shretina@sjtu.edu.cn.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. xdsun@sjtu.edu.cn.""}]","Eye (London, England)",['10.1038/s41433-019-0516-x']
536,31849201,Egg intervention effect on linear growth no longer present after two years.,"The Lulun Project, a randomized controlled trial conducted in 2015, found that one egg per day for 6 months during early complementary feeding reduced stunting by 47% and increased linear growth by 0.63 length-for-age Z (LAZ). This follow-up cohort study (Lulun Project II) aimed to test whether the growth effect remained in the egg intervention group compared with the control group after approximately 2 years. Mothers or caregivers from the Lulun Project were recontacted and recruited for this study. Enumerators collected data on socio-economic and demographic factors, 24-hr frequency of dietary intakes, morbidities, and anthropometric measures of height, weight, and head circumference using World Health Organization protocols. Statistical analyses followed the same analytical plan as Lulun Project, applying generalized linear models and regression modelling to test group differences in height-for-age z (HAZ) from LAZ at Lulun Project endline, and structural equation modelling for mediation. One hundred thirty-five mother-child dyads were included in Lulun II, with 11% losses to follow-up from endline Lulun Project. Growth faltering across all children was evident with HAZ -2.07 ± 0.91 and a stunting prevelance of 50%. Regression modelling showed no difference between egg and control groups for the HAZ outcome and other anthropometric outcomes, and significant declines in HAZ from endline Lulun Project in the egg intervention are compared with control groups. Current dietary egg intake, however, was associated with reduced growth faltering in HAZ from Lulun Project endline to Lulun Project II, independent of group assignment and through mediation, explaining 8.8% of the total effect. Findings suggest the need for a longer intervention period and ongoing nutrition support to young children during early childhood.",2020,"Regression modelling showed no difference between egg and control groups for the HAZ outcome and other anthropometric outcomes, and significant declines in HAZ from endline Lulun Project in the egg intervention are compared with control groups.","['Mothers or caregivers from the Lulun Project were recontacted and recruited for this study', '2015, found that one egg per day for 6 months during early complementary feeding reduced stunting by 47% and increased linear growth by 0.63 length-for-age Z (LAZ', 'young children during early childhood', 'One hundred thirty-five mother-child dyads were included in Lulun II, with 11% losses to follow-up from endline Lulun Project']",[],"['socio-economic and demographic factors, 24-hr frequency of dietary intakes, morbidities, and anthropometric measures of height, weight, and head circumference using World Health Organization protocols']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C4517468', 'cui_str': '0.63'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",[],"[{'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0011292', 'cui_str': 'Demographic Factors'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]",135.0,0.0339684,"Regression modelling showed no difference between egg and control groups for the HAZ outcome and other anthropometric outcomes, and significant declines in HAZ from endline Lulun Project in the egg intervention are compared with control groups.","[{'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Iannotti', 'Affiliation': 'Institute for Public Health, Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Chapnick', 'Affiliation': 'Institute for Public Health, Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Nicholas', 'Affiliation': 'School of Medicine, Pediatric Radiology, Mallinckrodt Institute of Radiology, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Carlos Andres', 'Initials': 'CA', 'LastName': 'Gallegos-Riofrio', 'Affiliation': 'Institute for Public Health, Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Moreno', 'Affiliation': 'Instituto de Investigación en Salud y Nutrición, Diego de Robles y Via Interoceánica, Universidad San Francisco de Quito, Quito, Ecuador.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Douglas', 'Affiliation': 'School of Medicine, Pediatric Radiology, Mallinckrodt Institute of Radiology, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Habif', 'Affiliation': 'Institute for Public Health, Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Yuhan', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Institute for Public Health, Brown School, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California.'}, {'ForeName': 'Chessa K', 'Initials': 'CK', 'LastName': 'Lutter', 'Affiliation': 'PAHO, Food Security and Agriculture, RTI International, Washington, DC, United States.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Waters', 'Affiliation': 'Instituto de Investigación en Salud y Nutrición, Diego de Robles y Via Interoceánica, Universidad San Francisco de Quito, Quito, Ecuador.'}]",Maternal & child nutrition,['10.1111/mcn.12925']
537,31228356,Effects of repetitive transcranial magnetic stimulation on children with low-function autism.,"BACKGROUND


Autism spectrum disorder (ASD) is a very complex neurodevelopmental disorder, characterized by social difficulties and stereotypical or repetitive behavior. Some previous studies using low-frequency repetitive transcranial magnetic stimulation (rTMS) have proven of benefit in ASD children.
METHODS


In this study, 32 children (26 males and six females) with low-function autism were enrolled, 16 children (three females and 13 males; mean ± SD age: 7.8 ± 2.1 years) received rTMS treatment twice every week, while the remaining 16 children (three females and 13 males; mean ± SD age: 7.2 ± 1.6 years) served as waitlist group. This study investigated the effects of rTMS on brain activity and behavioral response in the autistic children.
RESULTS


Peak alpha frequency (PAF) is an electroencephalographic measure of cognitive preparedness and might be a neural marker of cognitive function for the autism. Coherence is one way to assess the brain functional connectivity of ASD children, which has proven abnormal in previous studies. The results showed significant increases in the PAF at the frontal region, the left temporal region, the right temporal region and the occipital region and a significant increase of alpha coherence between the central region and the right temporal region. Autism Behavior Checklist (ABC) scores were also compared before and after receiving rTMS with positive effects shown on behavior.
CONCLUSION


These findings supported our hypothesis by demonstration of positive effects of combined rTMS neurotherapy in active treatment group as compared to the waitlist group, as the rTMS group showed significant improvements in behavioral and functional outcomes as compared to the waitlist group.",2019,"The results showed significant increases in the PAF at the frontal region, the left temporal region, the right temporal region and the occipital region and a significant increase of alpha coherence between the central region and the right temporal region.","['autistic children', '16 children (three females and 13 males; mean\xa0±\xa0SD age: 7.2\xa0±\xa01.6\xa0years) served as waitlist group', 'children with low-function autism', 'SD age: 7.8\xa0±\xa02.1\xa0years', 'Autism spectrum disorder (ASD', '32 children (26 males and six females) with low-function autism were enrolled, 16 children (three females and 13 males; mean\xa0±']","['repetitive transcranial magnetic stimulation', 'rTMS', 'low-frequency repetitive transcranial magnetic stimulation (rTMS']","['Autism Behavior Checklist (ABC) scores', 'behavioral and functional outcomes', 'alpha coherence', 'brain activity and behavioral response', 'PAF at the frontal region, the left temporal region, the right temporal region and the occipital region']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}]","[{'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0549224', 'cui_str': 'Frontal region'}, {'cui': 'C0039485', 'cui_str': 'Temporal Region'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0230005', 'cui_str': 'Occipital region structure'}]",32.0,0.0176346,"The results showed significant increases in the PAF at the frontal region, the left temporal region, the right temporal region and the occipital region and a significant increase of alpha coherence between the central region and the right temporal region.","[{'ForeName': 'Jian-Nan', 'Initials': 'JN', 'LastName': 'Kang', 'Affiliation': 'College of Electronic & Information Engineering, Hebei University, Baoding, China.'}, {'ForeName': 'Jia-Jia', 'Initials': 'JJ', 'LastName': 'Song', 'Affiliation': 'College of Electronic & Information Engineering, Hebei University, Baoding, China.'}, {'ForeName': 'Manuel F', 'Initials': 'MF', 'LastName': 'Casanova', 'Affiliation': 'Department of Biomedical Sciences, University of South Carolina School of Medicine Greenville Campus, Greenville Health System, Greenville, South Carolina.'}, {'ForeName': 'Estate M', 'Initials': 'EM', 'LastName': 'Sokhadze', 'Affiliation': 'Department of Biomedical Sciences, University of South Carolina School of Medicine Greenville Campus, Greenville Health System, Greenville, South Carolina.'}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}]",CNS neuroscience & therapeutics,['10.1111/cns.13150']
538,31320735,Intravitreal dexamethasone implant as an alternative to systemic steroids as prophylaxis for uveitic cataract surgery: a randomized trial.,"PURPOSE


To determine the utility of the dexamethasone implant (IVD) as an alternative to systemic steroids as prophylaxis against cystoid macular edema (CMO) in patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery.
METHODS


This was a randomized, parallel design, and clinical trial. Patients with IU/PU and cataract scheduled for cataract surgery were randomly assigned to receive the IVD concurrently with cataract surgery (Group 1: 20 patients) or systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care. Patients with glaucoma/contraindications to steroids were excluded. All patients were followed up for 6 months.
OUTCOME MEASURE


Primary-incidence of postoperative CMO. Secondary-the change in BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications. Appropriate statistical analysis was done.
RESULTS


The median age was 47.3 ± 4.23 years (group 1) and 49.12 ± 5.32 years (Group 2). One patient (Group 1) and two (Group 2) developed CMO. The BCVA improved significantly in both groups (p = 0.013). The CST change was insignificant. Four patients (Group 1) required intraocular pressure (IOP) lowering medications. Three patients (Group 2) required early steroid taper.
CONCLUSIONS


IVD is a good alternative as prophylaxis in IU/PU and cataract in preventing postoperative CMO.",2020,The BCVA improved significantly in both groups (p = 0.013).,"['uveitic cataract surgery', 'Patients with IU/PU and cataract scheduled for cataract surgery', 'The median age was 47.3\u2009±\u20094.23 years (group 1) and 49.12\u2009±\u20095.32 years (Group 2', 'Patients with glaucoma/contraindications to steroids were excluded', 'patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery']","['dexamethasone implant (IVD', 'IVD concurrently with cataract surgery', 'systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care', 'Intravitreal dexamethasone implant']","['CMO', 'BCVA', 'postoperative CMO', 'BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications', 'intraocular pressure (IOP) lowering medications']","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0042167', 'cui_str': 'Uveitis, Posterior'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",,0.0567074,The BCVA improved significantly in both groups (p = 0.013).,"[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Sudhalkar', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India. adityasudhalkar@yahoo.com.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Bhojwani', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Shail', 'Initials': 'S', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Samaresh', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}]","Eye (London, England)",['10.1038/s41433-019-0534-8']
539,31320738,Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data.,"BACKGROUND/OBJECTIVES


This post hoc analysis explores the relationship between residual oedema exposure after ranibizumab treatment initiation and long-term visual acuity outcome in eyes with centre-involved diabetic macular oedema (DMO).
SUBJECTS/METHODS


Eyes randomised to the ranibizumab + prompt or deferred laser treatment arms in the Protocol I trial and with observed central retinal thickness (CRT) readings at baseline and ≥1 follow-up visits (n = 367) were stratified by 1) oedema duration (number of study visits with CRT ≥ 250 µm during the first 52 weeks of ranibizumab treatment); and 2) oedema extent (amount of excess CRT [≥ 250 µm] at each study visit, averaged over the first 52 weeks). Associations between measures of residual oedema and best-corrected visual acuity (BCVA) were assessed in multiple regression analyses.
RESULTS


Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156. Eyes with the most persistent oedema gained (mean) 4.4 (95% CI 0.1─8.7) fewer Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 156 than eyes with the least persistent oedema (P = 0.044). Eyes with the greatest amount of oedema gained (mean) 9.3 (95% CI 4.0─14.5) fewer ETDRS letters at week 156 than eyes with the least amount of oedema (P < 0.001).
CONCLUSIONS


Macular oedema exposure over the first 52 weeks of ranibizumab treatment is a negative prognostic factor for long-term visual acuity improvement in centre-involved DMO.",2020,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","['diabetic macular oedema', 'eyes with centre-involved diabetic macular oedema (DMO']","['ranibizumab + prompt or deferred laser treatment', 'ranibizumab']","['oedema and visual acuity outcome', 'residual oedema and best-corrected visual acuity (BCVA', 'Oedema duration and oedema extent', 'ETDRS letters']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",367.0,0.11728,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","[{'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, CA, USA. SSadda@doheny.org.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Holekamp', 'Affiliation': 'Pepose Vision Institute and Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Szilárd', 'Initials': 'S', 'LastName': 'Kiss', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Augustin', 'Affiliation': 'Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Shih', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Whitcup', 'Affiliation': 'Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]","Eye (London, England)",['10.1038/s41433-019-0522-z']
540,30458263,Randomized trial seeking to induce the Hawthorne effect found no evidence for any effect on self-reported alcohol consumption online.,"OBJECTIVE


We tested the hypothesis that participants who know the behavioral focus of a study and are thus aware that a particular behavior is being studied will modify that behavior, independently of any possible effect of assessment, thereby dismantling a Hawthorne effect into two putative components.
STUDY DESIGN AND SETTING


We undertook a three-arm individually randomized trial online among students: group A (control) were told they were completing a lifestyle survey; group B were told the focus of the survey was alcohol consumption; and group C additionally answered 20 questions on their alcohol use and its consequences before answering the same lifestyle questions as Groups A and B. Nondrinkers were excluded, and all groups were aware they would be followed up after 1 month.
RESULTS


Outcome data were obtained for 4,583 of 5,478 trial participants (84% follow-up rate). There were no differences between the three groups on primary (overall volume consumed) or secondary outcome measures (drinking frequency and amount per typical occasion) in the intervening 4 weeks.
CONCLUSIONS


There is no evidence that any form of Hawthorne effect exists in relation to self-reported alcohol consumption online among university students in usual research practice. Attention to study contexts is warranted for investigating research participation effects.",2019,"There were no differences between the three groups on primary (overall volume consumed) or secondary outcome measures (drinking frequency and amount per typical occasion) in the intervening 4 weeks.
",['university students'],['alcohol consumption; and group C additionally answered 20 questions on their alcohol use and its consequences before answering the same lifestyle questions'],['primary (overall volume consumed) or secondary outcome measures (drinking frequency and amount per typical occasion'],"[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0445247', 'cui_str': 'Same (qualifier value)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.0341787,"There were no differences between the three groups on primary (overall volume consumed) or secondary outcome measures (drinking frequency and amount per typical occasion) in the intervening 4 weeks.
","[{'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'McCambridge', 'Affiliation': 'Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia; Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Attia', 'Affiliation': 'Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Weaver', 'Affiliation': 'Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Kypros', 'Initials': 'K', 'LastName': 'Kypri', 'Affiliation': 'Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia. Electronic address: kypros.kypri@newcastle.edu.au.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2018.11.016']
541,31369090,Overeating Saturated Fat Promotes Fatty Liver and Ceramides Compared With Polyunsaturated Fat: A Randomized Trial.,"CONTEXT


Saturated fatty acid (SFA) vs polyunsaturated fatty acid (PUFA) may promote nonalcoholic fatty liver disease by yet unclear mechanisms.
OBJECTIVE


To investigate if overeating SFA- and PUFA-enriched diets lead to differential liver fat accumulation in overweight and obese humans.
DESIGN


Double-blind randomized trial (LIPOGAIN-2). Overfeeding SFA vs PUFA for 8 weeks, followed by 4 weeks of caloric restriction.
SETTING


General community.
PARTICIPANTS


Men and women who are overweight or have obesity (n = 61).
INTERVENTION


Muffins, high in either palm (SFA) or sunflower oil (PUFA), were added to the habitual diet.
MAIN OUTCOME MEASURES


Lean tissue mass (not reported here). Secondary and exploratory outcomes included liver and ectopic fat depots.
RESULTS


By design, body weight gain was similar in SFA (2.31 ± 1.38 kg) and PUFA (2.01 ± 1.90 kg) groups, P = 0.50. SFA markedly induced liver fat content (50% relative increase) along with liver enzymes and atherogenic serum lipids. In contrast, despite similar weight gain, PUFA did not increase liver fat or liver enzymes or cause any adverse effects on blood lipids. SFA had no differential effect on the accumulation of visceral fat, pancreas fat, or total body fat compared with PUFA. SFA consistently increased, whereas PUFA reduced circulating ceramides, changes that were moderately associated with liver fat changes and proposed markers of hepatic lipogenesis. The adverse metabolic effects of SFA were reversed by calorie restriction.
CONCLUSIONS


SFA markedly induces liver fat and serum ceramides, whereas dietary PUFA prevents liver fat accumulation and reduces ceramides and hyperlipidemia during excess energy intake and weight gain in overweight individuals.",2019,"SFA had no differential effect on the accumulation of visceral fat, pancreas fat or total body fat compared with PUFA.","['General community', 'overweight and obese humans', 'Participants: n=61 overweight or obese men and women']","['Saturated fat (SFA) versus polyunsaturated fat (PUFA', 'Overeating saturated fat promotes fatty liver and ceramides', 'Muffins high in either palm (SFA)- or sunflower oil (PUFA', 'Overfeeding SFA vs PUFA']","['liver fat or liver enzymes', 'blood lipids', 'SFA', 'body weight gain', 'liver and ectopic fat depots', 'Lean tissue mass', 'accumulation of visceral fat, pancreas fat or total body fat', 'liver fat content', 'adverse metabolic effects of SFA']","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C2362518', 'cui_str': 'Polyunsaturated fat (substance)'}, {'cui': 'C0020505', 'cui_str': 'Polyphagia'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0452660', 'cui_str': 'Muffin (substance)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0340464', 'cui_str': 'Premature Cardiac Complex'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.090904,"SFA had no differential effect on the accumulation of visceral fat, pancreas fat or total body fat compared with PUFA.","[{'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Rosqvist', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Kullberg', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ståhlman', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cedernaes', 'Affiliation': 'Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Heurling', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Hans-Erik', 'Initials': 'HE', 'LastName': 'Johansson', 'Affiliation': 'Department of Public Health and Caring Sciences, Geriatrics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Iggman', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Wilking', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Eriksson', 'Affiliation': 'Antaros Medical AB, BioVenture Hub, Mölndal, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Johansson', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Straniero', 'Affiliation': 'Metabolism Unit, Endocrinology, Metabolism and Diabetes, and Integrated CardioMetabolic Center, Department of Medicine, Karolinska Institutet at Karolinska University Hospital, Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Rudling', 'Affiliation': 'Metabolism Unit, Endocrinology, Metabolism and Diabetes, and Integrated CardioMetabolic Center, Department of Medicine, Karolinska Institutet at Karolinska University Hospital, Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Antoni', 'Affiliation': 'Department of Medicinal Chemistry, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lubberink', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Marju', 'Initials': 'M', 'LastName': 'Orho-Melander', 'Affiliation': 'Department of Clinical Sciences in Malmö, Lund University Diabetes Centre, Lund University, Malmö, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Borén', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Ahlström', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Risérus', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Uppsala, Sweden.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00160']
542,31793233,The ABA intervention for improving breastfeeding initiation and continuation: Feasibility study results.,"The UK has low breastfeeding rates, with socioeconomic disparities. The Assets-based feeding help Before and After birth (ABA) intervention was designed to be inclusive and improve infant feeding behaviours. ABA is underpinned by the behaviour change wheel and offers an assets-based approach focusing on positive capabilities of individuals and communities, including use of a Genogram. This study aimed to investigate feasibility of intervention delivery within a randomised controlled trial (RCT). Nulliparous women ≥16 years, (n = 103) from two English sites were recruited and randomised to either intervention or usual care. The intervention - delivered through face-to-face, telephone and text message by trained Infant Feeding Helpers (IFHs) - ran from 30-weeks' gestation until 5-months postnatal. Outcomes included recruitment rates and follow-up at 3-days, 8-weeks and 6-months postnatal, with collection of future full trial outcomes via questionnaires. A mixed-methods process evaluation included qualitative interviews with 30 women, 13 IFHs and 17 maternity providers; IFH contact logs; and fidelity checking of antenatal contact recordings. This study successfully recruited women, including teenagers, from socioeconomically disadvantaged areas; postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3-days, 8-weeks and 6-months respectively. Breastfeeding at 8-weeks was obtained for 95.1% using routine data for non-responders. It was possible to recruit and train peer supporters to deliver the intervention with adequate fidelity. The ABA intervention was acceptable to women, IFHs and maternity services. There was minimal contamination and no evidence of intervention-related harm. In conclusion, the intervention is feasible to deliver within an RCT, and a definitive trial required.",2020,The Assets-based feeding help Before and After birth (ABA) intervention was designed to be inclusive and improve infant feeding behaviours.,"['recruited women, including teenagers, from socioeconomically disadvantaged areas; postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3-days, 8-weeks and 6-months respectively', 'Nulliparous women ≥16\xa0years, (n\xa0=\xa0103) from two English sites', '30 women, 13 IFHs and 17 maternity providers; IFH contact logs; and fidelity checking of antenatal contact recordings']","[""intervention - delivered through face-to-face, telephone and text message by trained Infant Feeding Helpers (IFHs) - ran from 30-weeks' gestation until 5-months postnatal"", 'intervention or usual care', 'ABA intervention']","['recruitment rates and follow-up at 3-days, 8-weeks and 6-months postnatal, with collection of future full trial outcomes via questionnaires']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0967482,The Assets-based feeding help Before and After birth (ABA) intervention was designed to be inclusive and improve infant feeding behaviours.,"[{'ForeName': 'Joanne L', 'Initials': 'JL', 'LastName': 'Clarke', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ingram', 'Affiliation': 'Centre for Academic Child Health, University of Bristol, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'Centre for Academic Child Health, University of Bristol, UK.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Thomson', 'Affiliation': 'Maternal and Infant Nutrition and Nurture Unit (MAINN), University of Central Lancashire, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Trickey', 'Affiliation': 'DECIPHER, Department of Social Medicine, Cardiff University, UK.'}, {'ForeName': 'Stephan U', 'Initials': 'SU', 'LastName': 'Dombrowski', 'Affiliation': 'Faculty of Kinesiology, University of New Brunswick, Canada.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sitch', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Dykes', 'Affiliation': 'Maternal and Infant Nutrition and Nurture Unit (MAINN), University of Central Lancashire, UK.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Feltham', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'MacArthur', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Roberts', 'Affiliation': 'Health Economic Unit, University of Birmingham, UK.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Hoddinott', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, UK.'}]",Maternal & child nutrition,['10.1111/mcn.12907']
543,31756291,Phenotype is sustained during hospital readmissions following treatment for complicated severe malnutrition among Kenyan children: A retrospective cohort study.,"Hospital readmission is common among children with complicated severe acute malnutrition (cSAM) but not well-characterised. Two distinct cSAM phenotypes, marasmus and kwashiorkor, exist, but their pathophysiology and whether the same phenotype persists at relapse are unclear. We aimed to test the association between cSAM phenotype at index admission and readmission following recovery. We performed secondary data analysis from a multicentre randomised trial in Kenya with 1-year active follow-up. The main outcome was cSAM phenotype upon hospital readmission. Among 1,704 HIV-negative children with cSAM discharged in the trial, 177 children contributed a total of 246 readmissions with cSAM. cSAM readmission was associated with age<12 months (p = .005), but not site, sex, season, nor cSAM phenotype. Of these, 42 children contributed 44 readmissions with cSAM that occurred after a monthly visit when SAM was confirmed absent (cSAM relapse). cSAM phenotype was sustained during cSAM relapse. The adjusted odds ratio for presenting with kwashiorkor during readmission after kwashiorkor at index admission was 39.3 [95% confidence interval (95% CI) [2.69, 1,326]; p = .01); and for presenting with marasmus during readmission after kwashiorkor at index admission was 0.02 (95% CI [0.001, 0.037]; p = .01). To validate this finding, we examined readmissions to Kilifi County Hospital, Kenya occurring at least 2 months after an admission with cSAM. Among 2,412 children with cSAM discharged alive, there were 206 readmissions with cSAM. Their phenotype at readmission was significantly influenced by their phenotype at index admission (p < .001). This is the first report describing the phenotype and rate of cSAM recurrence.",2020,"cSAM readmission was associated with age<12 months (p = .005), but not site, sex, season, nor cSAM phenotype.","['Kenyan children', '2,412 children with cSAM discharged alive, there were 206 readmissions with cSAM', '1,704 HIV-negative children with cSAM discharged in the trial, 177 children contributed a total of 246 readmissions with cSAM', 'children with complicated severe acute malnutrition (cSAM', 'Kenya with 1-year active follow-up', 'Kilifi County Hospital, Kenya occurring at least 2 months after an admission with cSAM']",[],"['cSAM phenotype upon hospital readmission', 'cSAM readmission', '44 readmissions with cSAM', 'Hospital readmission']","[{'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C2933140', 'cui_str': 'AM206 cpd'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0020005', 'cui_str': 'Hospitals, County'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}]",2412.0,0.11712,"cSAM readmission was associated with age<12 months (p = .005), but not site, sex, season, nor cSAM phenotype.","[{'ForeName': 'Gerard Bryan', 'Initials': 'GB', 'LastName': 'Gonzales', 'Affiliation': 'Laboratory of Gastroenterology, Department of Internal Medicine and Paediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Moses M', 'Initials': 'MM', 'LastName': 'Ngari', 'Affiliation': 'The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Njunge', 'Affiliation': 'The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya.'}, {'ForeName': 'Johnstone', 'Initials': 'J', 'LastName': 'Thitiri', 'Affiliation': 'The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mwalekwa', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Neema', 'Initials': 'N', 'LastName': 'Mturi', 'Affiliation': 'KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Martha K', 'Initials': 'MK', 'LastName': 'Mwangome', 'Affiliation': 'The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ogwang', 'Affiliation': 'The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya.'}, {'ForeName': 'Amek', 'Initials': 'A', 'LastName': 'Nyaguara', 'Affiliation': 'The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Berkley', 'Affiliation': 'The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya.'}]",Maternal & child nutrition,['10.1111/mcn.12913']
544,30989763,Differences between homeless women and men before and after the transition from shelter to community living: A longitudinal analysis.,"Social quality is the extent to which people are able to participate in social relationships under conditions which enhance their well-being, capacities and potential and enables them to shape their own circumstances and contribute to societal development. We assessed whether women in homeless shelters differed from men on social quality factors that constitute the quality of their daily life and whether factor scores changed at a different rate for women and men after shelter exit. Data were collected as part of a randomised controlled trial. In 18 shelters across the Netherlands, 183 participants were recruited between December 2010 and December 2012 and followed for 9 months. Adults were eligible if they were about to move from shelter to (supported) independent housing and their shelter stay had been shorter than 14 months. At baseline, women were significantly younger than men. They were more likely to have children, to have minor children staying with them, to be lower educated, to be unemployed and to have been victimised than men. Women had used more services and reported lower self-esteem, less satisfaction with health and empowerment and higher psychological distress. They were less likely than men to have used alcohol excessively or cannabis. We found no significant differences between women and men in changes over time on the social quality factors. As women were disadvantaged at baseline compared to men regarding many factors, we concluded that women in homeless shelters are a particularly vulnerable group. Moreover, an opportunity remains for shelter services to improve women's social quality during and after their shelter stay.",2019,"Women had used more services and reported lower self-esteem, less satisfaction with health and empowerment and higher psychological distress.","['18 shelters across the Netherlands, 183 participants were recruited between December 2010 and December 2012 and followed for 9\xa0months', 'Adults were eligible if they were about to move from shelter to (supported) independent housing and their shelter stay had been shorter than 14\xa0months', 'homeless women and men before and after the transition from shelter to community living', 'women in homeless shelters']",[],"['lower self-esteem', 'satisfaction with health and empowerment and higher psychological distress', 'social quality factors']","[{'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3874886', 'cui_str': 'Is about (attribute)'}, {'cui': 'C1269909', 'cui_str': 'MOVED FROM (attribute)'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0679136', 'cui_str': 'Low self-esteem (finding)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",183.0,0.0634094,"Women had used more services and reported lower self-esteem, less satisfaction with health and empowerment and higher psychological distress.","[{'ForeName': 'Renée', 'Initials': 'R', 'LastName': 'de Vet', 'Affiliation': 'Impuls - Netherlands Center for Social Care Research, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, the Netherlands.'}, {'ForeName': 'Mariëlle D', 'Initials': 'MD', 'LastName': 'Beijersbergen', 'Affiliation': 'Impuls - Netherlands Center for Social Care Research, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, the Netherlands.'}, {'ForeName': 'Danielle A M', 'Initials': 'DAM', 'LastName': 'Lako', 'Affiliation': 'Impuls - Netherlands Center for Social Care Research, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, the Netherlands.'}, {'ForeName': 'Albert M', 'Initials': 'AM', 'LastName': 'van Hemert', 'Affiliation': 'Department of Psychiatry, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Herman', 'Affiliation': 'Silberman School of Social Work at Hunter College, City University of New York, New York, New York.'}, {'ForeName': 'Judith R L M', 'Initials': 'JRLM', 'LastName': 'Wolf', 'Affiliation': 'Impuls - Netherlands Center for Social Care Research, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, the Netherlands.'}]",Health & social care in the community,['10.1111/hsc.12752']
545,31740469,"Integrated multisectoral strategy to improve girls' and women's nutrition before conception, during pregnancy and after birth in India (Swabhimaan): protocol for a prospective, non-randomised controlled evaluation.","INTRODUCTION


Swabhimaan is a community-based programme to improve adolescent girls' and women's nutrition in the rural areas of three Indian states-Bihar, Chhattisgarh and Odisha with high prevalence of undernutrition.
METHODS AND ANALYSIS


Swabhimaan has a nested prospective, non-randomised controlled evaluation. Since 2017, five intervention sites receive community-led interventions through national government's livelihood mission supported women's self-help group federations and five control sites will initiate these activities 36 months later, in 2020. Community-led activities aim to improve coverage of 18 interventions including adequacy of food consumed, prevention of micronutrient deficiencies, access to basic health services and special care of nutritionally 'at risk' girls and women, improving hygiene and access to water and sanitation services and access to family planning services. The evaluation includes baseline (2016-2017), midline (2018-2019) and endline (2020-2021) surveys covering 6638 adolescent girls, 2992 pregnant women and 8755 mothers of children under 2. The final impact analysis will be by intention to treat, comparing primary and secondary outcomes in five intervention areas and five control areas. The primary outcomes are: (1) a 15% reduction in the proportion of adolescent girls with a body mass index (BMI) <18.5 kg/m 2 ; (2) a 15% reduction in the proportion of mothers of children under two with a BMI <18.5 kg/m 2  and (3) and a 0.4 cm improvement in mean mid-upper arm circumference among pregnant women.
ETHICS AND DISSEMINATION


All procedures involving human subjects were approved by the Institutional Ethics Committee of the All India Institute of Medical Sciences, Bihar, Chhattisgarh and Odisha and in compliance with guidelines laid down in the Declaration of Helsinki. Evidence will inform maternal and preconception nutrition policy at national and state level.
TRIAL REGISTRATION NUMBER


58261b2f46876 and CTRI/2016/11/007482; Pre-results.",2019,"Swabhimaan is a community-based programme to improve adolescent girls' and women's nutrition in the rural areas of three Indian states-Bihar, Chhattisgarh and Odisha with high prevalence of undernutrition.
","['6638 adolescent girls, 2992 pregnant women and 8755 mothers of children under 2', ""adolescent girls' and women's nutrition in the rural areas of three Indian states-Bihar, Chhattisgarh and Odisha with high prevalence of undernutrition""]","[""community-led interventions through national government's livelihood mission supported women's self-help group federations and five control sites"", 'Swabhimaan']",['proportion of adolescent girls with a body mass index (BMI'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",2992.0,0.0592726,"Swabhimaan is a community-based programme to improve adolescent girls' and women's nutrition in the rural areas of three Indian states-Bihar, Chhattisgarh and Odisha with high prevalence of undernutrition.
","[{'ForeName': 'Vani', 'Initials': 'V', 'LastName': 'Sethi', 'Affiliation': 'Child Development and Nutrition, UNICEF India, New Delhi, India vsethi@unicef.org.'}, {'ForeName': 'Arti', 'Initials': 'A', 'LastName': 'Bhanot', 'Affiliation': 'Independent Consultant, New Delhi, India.'}, {'ForeName': 'Sourav', 'Initials': 'S', 'LastName': 'Bhattacharjee', 'Affiliation': 'Nutrition section, UNICEF Odisha, Bhubaneshwar, India.'}, {'ForeName': 'Rajkumar', 'Initials': 'R', 'LastName': 'Gope', 'Affiliation': 'Ekjut, Chakradharpur, India.'}, {'ForeName': 'Debjeet', 'Initials': 'D', 'LastName': 'Sarangi', 'Affiliation': 'Living Farms, Bhubanehwar, India.'}, {'ForeName': 'Vikash', 'Initials': 'V', 'LastName': 'Nath', 'Affiliation': 'Ekjut, Chakradharpur, India.'}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Nair', 'Affiliation': 'Ekjut, Chakradharpur, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Singh', 'Affiliation': 'Dr Rajendra Prasad Central Agricultural University, Samastipur, India.'}, {'ForeName': 'Abner', 'Initials': 'A', 'LastName': 'Daniel', 'Affiliation': 'Child Development and Nutrition, UNICEF India, New Delhi, India.'}, {'ForeName': 'Rabi N', 'Initials': 'RN', 'LastName': 'Parhi', 'Affiliation': 'Nutrition section, UNICEF Bihar, Patna, India.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Nutrition section, UNICEF Odisha, Bhubaneshwar, India.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Loomba', 'Affiliation': 'Nutrition section, UNICEF Chhattisgarh, Raipur, India.'}, {'ForeName': 'Somya', 'Initials': 'S', 'LastName': 'S', 'Affiliation': 'Bihar Rural Livelihoods Promotion Society, Patna, India.'}, {'ForeName': 'Apollo', 'Initials': 'A', 'LastName': 'Purty', 'Affiliation': 'Bihar Rural Livelihoods Promotion Society, Patna, India.'}, {'ForeName': 'Naushad', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Independent Consultant, Patna, India.'}, {'ForeName': 'Babita', 'Initials': 'B', 'LastName': 'Mohapatra', 'Affiliation': 'Odisha Livelihoods Mission, Bhubaneshwar, India.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Community and Family Medicince, All India Institute of Medical Sciences (AIIMS), Patna, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Bhatia', 'Affiliation': 'Community and Family Medicine, All India Institute of Medical Sciences Bhubaneswar, Bhubaneswar, India.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Ruikar', 'Affiliation': 'Community and Family Medicine, All India Institute of Medical Sciences, Raipur, India.'}, {'ForeName': 'Bharati', 'Initials': 'B', 'LastName': 'Sahu', 'Affiliation': 'Independent Consultant, Bhubaneshwar, India.'}, {'ForeName': 'Reshmi', 'Initials': 'R', 'LastName': 'R S', 'Affiliation': 'International Institute for Population Sciences, Mumbai, India.'}, {'ForeName': 'Sarang', 'Initials': 'S', 'LastName': 'Pedgaonkar', 'Affiliation': 'International Institute for Population Sciences, Mumbai, India.'}, {'ForeName': 'Laxmi Kant', 'Initials': 'LK', 'LastName': 'Dwivedi', 'Affiliation': 'International Institute for Population Sciences, Mumbai, India.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Saiyed', 'Affiliation': 'Nutrition section, UNICEF Chhattisgarh, Raipur, India.'}, {'ForeName': 'Mahendra', 'Initials': 'M', 'LastName': 'Prajapati', 'Affiliation': 'Nutrition section, UNICEF Bihar, Patna, India.'}, {'ForeName': 'Preetu', 'Initials': 'P', 'LastName': 'Mishra', 'Affiliation': 'Nutrition section, UNICEF Chhattisgarh, Raipur, India.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Prost', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Kejrewal', 'Affiliation': 'Deendayal Antyodaya Yojana, National Rural Livelihoods Mission, New Delhi, India.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'De Wagt', 'Affiliation': 'Child Development and Nutrition, UNICEF India, New Delhi, India.'}, {'ForeName': 'Harshpal', 'Initials': 'H', 'LastName': 'Sachdev', 'Affiliation': 'Department of Paediatrics, Sitaram Bhartia Institute of Science and Research, New Delhi, India.'}, {'ForeName': 'Sayeed', 'Initials': 'S', 'LastName': 'Unisa', 'Affiliation': 'International Institute for Population Sciences, Mumbai, India.'}]",BMJ open,['10.1136/bmjopen-2019-031632']
546,31765640,Impact of treatment for Fecal Incontinence on Constipation Symptoms.,"OBJECTIVE


Defecatory symptoms, such as sense of incomplete emptying and straining with bowel movements, are paradoxically present in women with fecal incontinence (FI). Treatments for FI, such as loperamide and biofeedback, can worsen or improve defecatory symptoms, respectively. The primary aim of this study was to compare changes in constipation symptoms in women undergoing treatment for FI with education only, loperamide, anal muscle exercises with biofeedback, or both loperamide and biofeedback. Our secondary aim was to compare changes in constipation symptoms among responders and non-responders to FI treatment.
METHODS


This was a planned secondary analysis of a randomized controlled trial comparing 2 first-line therapies for FI in a 2x2 factorial design. Women with at least monthly FI and normal stool consistency were randomized to 4 groups: 1) oral placebo plus education only, 2) oral loperamide plus education only, 3) placebo plus anorectal manometry-assisted biofeedback and 4) loperamide plus biofeedback. Defecatory symptoms were measured using the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at baseline, 12 weeks and 24 weeks. The PAC-SYM consists of 12 items that contribute to a global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps). Scores for each subscale as well as the global score range from 0 (no symptoms) to 4 (maximum score), with negative change scores representing improvement in defecatory symptoms. Responders to FI treatment were defined as women with a minimally important clinical improvement of ≥5-points on the St. Mark's (Vaizey) scale between baseline and 24 weeks. Intent-to-treat analysis was performed using a longitudinal mixed model, controlling for baseline scores, to estimate changes in PAC-SYM scores from baseline through 24 weeks.
RESULTS


At 24 weeks, there were small changes in PAC-SYM global scores in all four groups: oral placebo plus education (-0.3; 95% CI -0.5, -0.1), loperamide plus education (-0.1, 95% CI -0.3, 0.0), oral placebo plus biofeedback (-0.3, 95% CI -0.4, -0.2), and loperamide plus biofeedback (-0.3, 95% CI -0.4, -0.2). No differences were observed in change in PAC-SYM scores between women randomized to placebo plus education and those randomized to loperamide plus education (p=0.17) or placebo plus biofeedback (p=0.82). Change in PAC-SYM scores in women randomized to combination loperamide plus biofeedback therapy was not different from that of women randomized to treatment with loperamide or biofeedback alone. Responders had greater improvement in PAC-SYM scores than non-responders (-0.4; 95% CI -0.5, -0.3 vs. -0.2; 95% CI -0.3, -0.0, p<0.01, mean difference 0.2, 95% CI 0.1, 0.4).
CONCLUSION


Change in constipation symptoms following treatment of FI in women are small and are not significantly different between groups. Loperamide treatment for FI does not worsen constipation symptoms among women with normal consistency stool. Women with clinically significant improvement in FI symptoms report greater improvement in constipation symptoms.",2019,No differences were observed in change in PAC-SYM scores between women randomized to placebo plus education and those randomized to loperamide plus education (p=0.17) or placebo plus biofeedback (p=0.82).,"['Women with at least monthly FI and normal stool consistency', 'Fecal Incontinence on Constipation Symptoms', 'women with fecal incontinence (FI', 'women undergoing treatment for FI with education only', 'women with normal consistency stool']","['placebo', 'placebo plus biofeedback', 'loperamide, anal muscle exercises with biofeedback, or both loperamide and biofeedback', 'combination loperamide plus biofeedback therapy', 'oral placebo plus education only, 2) oral loperamide plus education only, 3) placebo plus anorectal manometry-assisted biofeedback and 4) loperamide plus biofeedback']","['PAC-SYM scores', 'PAC-SYM global scores', 'constipation symptoms', 'loperamide plus biofeedback', 'FI symptoms', 'loperamide plus education', 'Constipation Symptoms (PAC-SYM) questionnaire', 'global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps', ""St. Mark's (Vaizey) scale"", 'Defecatory symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332530', 'cui_str': 'Normal consistency (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3652856', 'cui_str': 'loperamide, combinations'}, {'cui': 'C0005491', 'cui_str': 'Feedback, Psychophysiologic'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0374190', 'cui_str': 'Anorectal manometry'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0426739', 'cui_str': 'Stool size'}, {'cui': 'C0558921', 'cui_str': 'Rectal symptoms (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0740651', 'cui_str': 'Abdominal symptom'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C1446787', 'cui_str': 'Cramping'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0222045'}]",,0.676002,No differences were observed in change in PAC-SYM scores between women randomized to placebo plus education and those randomized to loperamide plus education (p=0.17) or placebo plus biofeedback (p=0.82).,"[{'ForeName': 'Uduak U', 'Initials': 'UU', 'LastName': 'Andy', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA. Electronic address: uduakumoh.andy@uphs.upenn.edu.'}, {'ForeName': 'J Eric', 'Initials': 'JE', 'LastName': 'Jelovsek', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carper', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Isuzu', 'Initials': 'I', 'LastName': 'Meyer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Keisha Y', 'Initials': 'KY', 'LastName': 'Dyer', 'Affiliation': 'Department of Obstetrics and Gynecology Kaiser Permanente, San Diego, CA.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Rogers', 'Affiliation': ""Department of Women's Health, Dell Medical School, University of Texas at Austin. Austin, TX and The University of New Mexico Health Sciences Center, Albuquerque NM.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Korbly', 'Affiliation': 'Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Sassani', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.11.1256']
547,31885221,Effectiveness of a locally produced ready-to-use supplementary food in preventing growth faltering for children under 2 years in Cambodia: a cluster randomised controlled trial.,"This cluster randomised controlled trial tested the effectiveness of a locally produced, fish-based, ready-to-use supplementary food (RUSF) to prevent growth faltering (decline in z-scores). Cambodian infants (n= 485), aged 6 to 11 months, were randomised by site to receive the RUSF, Corn-Soy Blend++ (CSB++), micronutrient powders (MNP), or no supplement (control). The intervention was for 6 months. In unadjusted analysis, the control group had statistically significantly decreased weight-for-age z-scores (WAZ; -0.02, 95%CI = -0.03 - -0.01, P= 0.001) and height-for-age z-scores (HAZ; -0.07, 95%CI = -0.09 - -0.05, P < 0.001), and increased mid-upper arm-circumference (MUAC; 0.02cm, 95%CI = 0.01 - 0.04, P = 0.010), but no statistically significant change in weight-for-height z-scores (WHZ). The RUSF group did not differ significantly from the control for WAZ, HAZ or WHZ (in other words, WAZ and HAZ decreased and WHZ did not change), but had increased MUAC in comparison to the control (0.04cm, 95%CI = 0.01 - 0.06, P = 0.008). There were no statistically significant differences between the RUSF group and the CSB++ or MNP groups with respect to WAZ, HAZ, WHZ or MUAC. Interestingly, in adjusted analysis, low consumers of RUSF had increased WAZ, WHZ and MUAC (0.03, 95%CI = 0.01-0.06, P = 0.006; 0.04, 95%CI = 0.01-0.08, P = 0.026; and 0.05cm, 95%CI = 0.02-0.09, P = 0.004, respectively) compared with the control. The novel RUSF, particularly in small quantities, protected against ponderal growth faltering, but the improvements were of limited clinical significance.",2020,"There were no statistically significant differences between the RUSF group and the CSB++ or MNP groups with respect to WAZ, HAZ, WHZ or MUAC.","['Cambodian infants (n= 485), aged 6 to 11 months', 'children under 2 years in Cambodia']","['RUSF', 'locally produced, fish-based, ready-to-use supplementary food (RUSF', 'locally produced ready-to-use supplementary food', 'RUSF, Corn-Soy Blend++ (CSB++), micronutrient powders (MNP), or no supplement (control']","['MUAC', 'weight-for-age z-scores', 'control for WAZ, HAZ or WHZ', 'weight-for-height z-scores (WHZ']","[{'cui': 'C1553323', 'cui_str': 'Cambodians'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006797', 'cui_str': 'Khmer Republic'}]","[{'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0424670', 'cui_str': 'Weight for height (observable entity)'}]",485.0,0.185361,"There were no statistically significant differences between the RUSF group and the CSB++ or MNP groups with respect to WAZ, HAZ, WHZ or MUAC.","[{'ForeName': 'Bindi', 'Initials': 'B', 'LastName': 'Borg', 'Affiliation': 'School of Public Health, Faculty of Medicine, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Daream', 'Initials': 'D', 'LastName': 'Sok', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mihrshahi', 'Affiliation': 'School of Public Health, Faculty of Medicine, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'School of Public Health, Faculty of Medicine, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Chhoun', 'Initials': 'C', 'LastName': 'Chamnan', 'Affiliation': 'Department of Fisheries Post-Harvest Technologies and Quality Control, Fisheries Administration, Ministry of Agriculture, Forestry and Fisheries, Phnom Penh, Cambodia.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Berger', 'Affiliation': 'UMR-204 Nutripass, Institut de Recherche pour le Développement, IRD/UM/SupAgro, Montpellier, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Laillou', 'Affiliation': 'Child Survival and Development Section, UNICEF, Phnom Penh, Cambodia.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Roos', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frank T', 'Initials': 'FT', 'LastName': 'Wieringa', 'Affiliation': 'UMR-204 Nutripass, Institut de Recherche pour le Développement, IRD/UM/SupAgro, Montpellier, France.'}]",Maternal & child nutrition,['10.1111/mcn.12896']
548,31915207,Long-term functional outcome following minimally invasive endoscopic intracerebral hemorrhage evacuation.,"BACKGROUND AND PURPOSE


Preclinical studies suggest that clot removal may mitigate primary and secondary brain injury following intracerebral hemorrhage (ICH). Although the MISTIE trial did not demonstrate an overall outcome benefit, it did demonstrate outcome benefit from effective reduction of clot burden. Minimally invasive endoscopic ICH evacuation may provide an alternative option for clot evacuation.
METHODS


Patients presenting to a single healthcare system from December 2015 to October 2018 with supratentorial spontaneous ICH were evaluated for minimally invasive endoscopic evacuation. Inclusion and exclusion criteria were prospectively established by a multidisciplinary group in the healthcare system. The prespecified primary analysis was the proportion of patients with modified Rankin Score (mRS) 0-3 at 6 months.
RESULTS


One hundred patients met the inclusion and exclusion criteria and underwent minimally invasive endoscopic ICH evacuation. The mean (SD) hematoma size was 49.7 (30.6) mL, the mean (SD) evacuation percentage was 88.2 (20.3)%, and 86% of patients had postoperative residual hematoma ≤15 mL. At 6 months the proportion of patients with an mRS of 0-3 was 46%.
CONCLUSIONS


This study suggests that minimally invasive endoscopic ICH evacuation may produce favorable long-term functional outcomes. Further evaluation of this technique in a randomized clinical trial is necessary.",2020,"Although the MISTIE trial did not demonstrate an overall outcome benefit, it did demonstrate outcome benefit from effective reduction of clot burden.","['intracerebral hemorrhage (ICH', 'One hundred patients met the inclusion and exclusion criteria and underwent minimally invasive endoscopic ICH evacuation', 'Patients presenting to a single healthcare system from December 2015 to October 2018 with supratentorial spontaneous ICH', 'minimally invasive endoscopic intracerebral hemorrhage evacuation']","['minimally invasive endoscopic evacuation', 'Minimally invasive endoscopic ICH evacuation', 'minimally invasive endoscopic ICH evacuation']","['mean (SD) evacuation percentage', 'postoperative residual hematoma', 'proportion of patients with modified Rankin Score (mRS', 'mean (SD) hematoma size']","[{'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3888574', 'cui_str': 'Modified Rankin score'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",100.0,0.214503,"Although the MISTIE trial did not demonstrate an overall outcome benefit, it did demonstrate outcome benefit from effective reduction of clot burden.","[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Kellner', 'Affiliation': ''}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Dominic A', 'Initials': 'DA', 'LastName': 'Nistal', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Scaggiante', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Chartrain', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Rumsey', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Hom', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Dangayach', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Rupendra', 'Initials': 'R', 'LastName': 'Swarup', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Tuhrim', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Saadi', 'Initials': 'S', 'LastName': 'Ghatan', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Bederson', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mocco', 'Affiliation': 'Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-015528']
549,30814669,Influence of training protocols on text input speed on a computer in individuals with cervical spinal cord injury: a randomised controlled trial.,"STUDY DESIGN


Randomised controlled trial.
OBJECTIVES


To evaluate the impact of two different word prediction software (WPS) training protocols on text input speed (TIS) in people with tetraplegia and to determine which was the most effective.
SETTING


Rehabilitation department, Garches, France.
METHODS


Participants with neurological levels between C6 and C8 were allocated to one of three different groups. The REHAB group underwent training with an occupational therapist. The SELF group carried out a standardised home self-training with a written training guide. The CONTROL group had no training. Participants were assessed at day 15 (D15) and day 30 (D30). The primary outcome was a copying task with and without WPS (WITH and WITHOUT).
RESULTS


Forty-two participants (mean age ± SD of 39.8 ± 12) were included and 38 completed the study. At D30, the mean (95% confidence interval) difference in TIS between the CONTROL and SELF groups was 3.8 [-1.7 to 9.4] characters per minute (cpm) (p = 0.23), between the REHAB and SELF groups was 12.9 [7.4 to 18.4] cpm (p < 0.001), and between the REHAB and CONTROL groups was 9.1 [3.5 to 14.6] cpm (p < 0.001).
CONCLUSIONS


The results of this study showed that occupational therapist-supervised training improved TIS but word prediction software did not increase TIS. These results suggest that supervised training should be provided to all individuals who are prescribed with devices and systems to facilitate computer access in order to increase their TIS.",2019,"To evaluate the impact of two different word prediction software (WPS) training protocols on text input speed (TIS) in people with tetraplegia and to determine which was the most effective.
","['Participants with neurological levels between C6 and C8', 'individuals with cervical spinal cord injury', 'people with tetraplegia', 'Forty-two participants (mean age\u2009±\u2009SD of 39.8\u2009±\u200912) were included and 38 completed the study', 'Rehabilitation department, Garches, France']","['training protocols', 'word prediction software (WPS) training protocols', 'standardised home self-training with a written training guide', 'training with an occupational therapist']","['TIS', 'text input speed (TIS', 'copying task with and without WPS (WITH and WITHOUT']","[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0587478', 'cui_str': 'Rehabilitation department (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}]","[{'cui': 'C3541382', 'cui_str': 'Text'}]",,0.0702357,"To evaluate the impact of two different word prediction software (WPS) training protocols on text input speed (TIS) in people with tetraplegia and to determine which was the most effective.
","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Pouplin', 'Affiliation': 'New Technologies Plate-Form, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France. samuel.pouplin@aphp.fr.'}, {'ForeName': 'Djamel', 'Initials': 'D', 'LastName': 'Bensmail', 'Affiliation': 'New Technologies Plate-Form, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vaugier', 'Affiliation': 'Clinical Innovations Centre 1429, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France.'}, {'ForeName': 'Axelle', 'Initials': 'A', 'LastName': 'Gelineau', 'Affiliation': 'New Technologies Plate-Form, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Pottier', 'Affiliation': 'Clinical Innovations Centre 1429, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': 'Inserm Unit 1179, Team 3: Technologies and Innovative Therapies Applied to Neuromuscular Diseases, University of Versailles, St-Quentin-en-Yvelines, France.'}]",Spinal cord,['10.1038/s41393-019-0265-5']
550,31127284,Improving Tuberculosis Preventive Therapy Uptake: A Cluster-randomized Trial of Symptom-based Versus Tuberculin Skin Test-based Screening of Household Tuberculosis Contacts Less Than 5 Years of Age.,"BACKGROUND


Tuberculosis preventive therapy (TPT) is highly effective at preventing tuberculosis disease in household child contacts (<5 years), but is poorly implemented worldwide. In 2006, the World Health Organization recommended symptom-based screening as a replacement for tuberculin skin testing (TST) to simplify contact evaluation and improve implementation. We aimed to determine the effectiveness of this recommendation.
METHODS


We conducted a pragmatic, cluster-randomized trial to determine whether contact evaluation using symptom screening improved the proportion of identified child contacts who initiated TPT, compared to TST-based screening, in Matlosana, South Africa. We randomized 16 clinics to either symptom-based or TST-based contact evaluations. Outcome data were abstracted from customized child contact management files.
RESULTS


Contact tracing identified 550 and 467 child contacts in the symptom and TST arms, respectively (0.39 vs 0.32 per case, respectively; P = .27). There was no significant difference by arm in the adjusted proportion of identified child contacts who were screened (52% in symptom arm vs 60% in TST arm; P = .39). The adjusted proportion of identified child contacts who initiated TPT or tuberculosis treatment was 51.5% in the symptom clinics and 57.1% in the TST clinics (difference -5.6%, 95% confidence interval -23.7 to 12.6; P = .52). Based on the district's historic average of 0.7 child contacts per index case, 14% and 15% of child contacts completed 6 months of TPT in the symptom and TST arms, respectively (P = .89).
CONCLUSIONS


Symptom-based screening did not improve the proportion of identified child contacts evaluated or initiated on TPT, compared to TST-based screening. Further research is needed to identify bottlenecks and evaluate interventions to ensure all child contacts receive TPT.
CLINICAL TRIALS REGISTRATION


NCT03074799.",2020,"CONCLUSIONS


Symptom-based screening did not improve the proportion of identified child contacts evaluated or initiated on TPT compared to TST-based screening.","['Household Tuberculosis Contacts', 'proportion of identified child contacts who initiated TPT compared to TST-based screening in Matlosana, South Africa', 'Sixteen clinics']","['symptom-based or TST-based contact evaluation', 'Symptom-Based Versus Tuberculin Skin Test-Based Screening']","['adjusted proportion of identified child contacts', 'TPT Uptake']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0050127', 'cui_str': 'TPTPT'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0041289', 'cui_str': 'Tuberculin'}, {'cui': 'C0037296', 'cui_str': 'Skin Tests'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0050127', 'cui_str': 'TPTPT'}]",16.0,0.0785813,"CONCLUSIONS


Symptom-based screening did not improve the proportion of identified child contacts evaluated or initiated on TPT compared to TST-based screening.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Salazar-Austin', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cohn', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Grace Link', 'Initials': 'GL', 'LastName': 'Barnes', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Molefi', 'Initials': 'M', 'LastName': 'Tladi', 'Affiliation': 'Perinatal Human Immunodeficiency Virus Research Unit, University of Witwatersrand, Johannesburg.'}, {'ForeName': 'Katlego', 'Initials': 'K', 'LastName': 'Motlhaoleng', 'Affiliation': 'Perinatal Human Immunodeficiency Virus Research Unit, University of Witwatersrand, Johannesburg.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Swanepoel', 'Affiliation': 'Matlosana Sub-district Department of Health, Klerksdorp/Tshepong Hospital Complex, North West Province Department of Health, Johannesburg, South Africa.'}, {'ForeName': 'Zarina', 'Initials': 'Z', 'LastName': 'Motala', 'Affiliation': 'Matlosana Sub-district Department of Health, Klerksdorp/Tshepong Hospital Complex, North West Province Department of Health, Johannesburg, South Africa.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Variava', 'Affiliation': 'Perinatal Human Immunodeficiency Virus Research Unit, University of Witwatersrand, Johannesburg.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martinson', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Chaisson', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz436']
551,31141837,"Relationship between early-life nutrition and ages at menarche and first pregnancy, and childbirth rates of young adults: Evidence from APCAPS in India.","India's Integrated Child Development Services (ICDS) provides daily supplementary nutrition and other public health services to women and children. We estimated associations between exposure to early-childhood ICDS nutrition and adult reproductive outcomes. During 1987-1990, a balanced protein-calorie supplement called ""upma""-made from locally available corn-soya ingredients-was rolled out by subdistricts near Hyderabad and offered to pregnant women and children under age 6 years. In a controlled trial, 15 villages received the supplement and 14 did not. We used data from a 2010-2012 resurvey of adults born during the trial (n = 715 in intervention and n = 645 in control arms). We used propensity score matching methods to estimate the associations between birth in an intervention village and menarcheal age, age at first pregnancy, and fertility of adults. We found that women born in the intervention group during the trial, as compared with the control group, had menarche 0.45 (95% confidence interval [CI: 0.22, 0.68]; p < .001) years later and first pregnancy 0.53 (95% CI [0.04, 1.02]; p < .05) years later. Married women from the intervention group had menarche 0.36 (95% CI [0.09, 0.64]; p < .01) years later, first cohabitation with partner 0.8 (95% CI [0.27, 1.33]; p < .01) years later, and first pregnancy 0.53 (95% CI [0.04, 1.02]; p < .05) years later than married women in the control group. There was no significant difference between intervention and control group women regarding whether they had at least one childbirth or the total number of children born. The findings were similar when we employed inverse propensity score weighted regression models.",2020,There was no significant difference between intervention and control group women regarding whether they had at least one childbirth or the total number of children born.,"['pregnant women and children under age 6\xa0years', 'women and children', 'young adults', 'Married women from the intervention group had menarche 0.36', '2010-2012 resurvey of adults born during the trial (n\xa0=\xa0715 in intervention and n\xa0=\xa0645 in control arms']","[""India's Integrated Child Development Services (ICDS"", 'balanced protein-calorie supplement called ""upma""-made from locally available corn-soya ingredients-was rolled out by subdistricts near Hyderabad']",[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025274', 'cui_str': 'Menarche'}, {'cui': 'C4517452', 'cui_str': '0.36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0037733', 'cui_str': 'Soy Beans'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}]",[],,0.133344,There was no significant difference between intervention and control group women regarding whether they had at least one childbirth or the total number of children born.,"[{'ForeName': 'Arindam', 'Initials': 'A', 'LastName': 'Nandi', 'Affiliation': 'Center for Disease Dynamics, Economics & Policy, Washington, DC, Washington, District of Columbia.'}, {'ForeName': 'Jere R', 'Initials': 'JR', 'LastName': 'Behrman', 'Affiliation': 'Departments of Economics and Sociology, Population Studies Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Black', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kinra', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Ramanan', 'Initials': 'R', 'LastName': 'Laxminarayan', 'Affiliation': 'Center for Disease Dynamics, Economics & Policy, New Delhi, New Delhi, India.'}]",Maternal & child nutrition,['10.1111/mcn.12854']
552,31232512,The cost of improving nutritional outcomes through food-assisted maternal and child health and nutrition programmes in Burundi and Guatemala.,"Evidence on the cost-effectiveness of multisectoral maternal and child health and nutrition programmes is scarce. We conducted a prospective costing study of two food-assisted maternal and child health and nutrition programmes targeted to pregnant women and children during the first 1,000 days (pregnancy to 2 years). Each was paired with a cluster-randomized controlled trial to evaluate impact and compare the optimal quantity and composition of food rations (Guatemala, five treatment arms) and their optimal timing and duration (Burundi, three treatment arms). We calculated the total and per beneficiary cost, conducted cost consequence analyses, and estimated the cost savings from extending the programme for 2 years. In Guatemala, the programme model with the lowest cost per percentage point reduction in stunting provided the full-size family ration with an individual ration of corn-soy blend or micronutrient powder. Reducing family ration size lowered costs but failed to reduce stunting. In Burundi, providing food assistance for the full 1,000 days led to the lowest cost per percentage point reduction in stunting. Reducing the duration of ration eligibility reduced per beneficiary costs but was less effective. A 2-year extension could have saved 11% per beneficiary in Guatemala and 18% in Burundi. We found that investments in multisectoral nutrition programmes do not scale linearly. Programmes providing smaller rations or rations for shorter durations, although less expensive per beneficiary, may not provide the necessary dose to improve (biological) outcomes. Lastly, delivering effective programmes for longer periods can generate cost savings by dispersing start-up costs and lengthening peak operating capacity.",2020,"In Burundi, providing food assistance for the full 1,000 days led to the lowest cost per percentage point reduction in stunting.","['Burundi and Guatemala', 'pregnant women and children during the first 1000 days (pregnancy to two years']","['multisectoral maternal and child health and nutrition (MCHN', 'food-assisted MCHN']",['duration of ration eligibility reduced per beneficiary costs'],"[{'cui': 'C0006448', 'cui_str': 'Republic of Burundi'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0363949,"In Burundi, providing food assistance for the full 1,000 days led to the lowest cost per percentage point reduction in stunting.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Heckert', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC.'}, {'ForeName': 'Jef L', 'Initials': 'JL', 'LastName': 'Leroy', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC.'}, {'ForeName': 'Deanna K', 'Initials': 'DK', 'LastName': 'Olney', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Richter', 'Affiliation': 'Michigan State University, work conducted while affiliated with Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC.'}, {'ForeName': 'Elyse', 'Initials': 'E', 'LastName': 'Iruhiriye', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Ruel', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC.'}]",Maternal & child nutrition,['10.1111/mcn.12863']
553,32295092,Response of the Human Milk Microbiota to A Maternal Prebiotic Intervention is Individual and Influenced by Maternal Age.,"Maternal bacteria are shared with infants via breastfeeding. Prebiotics modulate the gut microbiota, promoting health benefits. We investigated whether the maternal diet supplementation with a prebiotic (fructooligosaccharides, FOS) could influence the milk microbiota. Twenty-eight lactating women received 4.5 g of fructooligosaccharides + 2 g of maltodextrin (FOS group) and twenty-five received 2 g of maltodextrin (placebo group) for 20 days. Breast-milk samples were taken before and after the intervention. The DNA from samples was used for 16S rRNA sequencing. No statistical differences between the groups were found for the bacterial genera after the intervention. However, the distances of the trajectories covered by paired samples from the beginning to the end of the supplementation were higher for the FOS group ( p  = 0.0007) indicating greater changes in milk microbiota compared to the control group. Linear regression models suggested that the maternal age influenced the response for FOS supplementation ( p  = 0.02). Interestingly, the pattern of changes to genus abundance upon supplementation was not shared between mothers. We demonstrated that manipulating the human milk microbiota through prebiotics is possible, and the maternal age can affect this response.&nbsp.",2020,No statistical differences between the groups were found for the bacterial genera after the intervention.,['Twenty-eight lactating women'],"['fructooligosaccharides + 2 g of maltodextrin (FOS group) and twenty-five received 2 g of maltodextrin (placebo', 'maternal diet supplementation with a prebiotic (fructooligosaccharides, FOS']",['milk microbiota'],"[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0087140', 'cui_str': 'v-fos Oncogenes'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",28.0,0.0224471,No statistical differences between the groups were found for the bacterial genera after the intervention.,"[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Padilha', 'Affiliation': 'School of Pharmaceutical Sciences, University of São Paulo, São Paulo 05508-000, Brazil.'}, {'ForeName': 'Asker', 'Initials': 'A', 'LastName': 'Brejnrod', 'Affiliation': 'Laboratory of Genomics and Molecular Biomedicine, Department of Biology, University of Copenhagen, Copenhagen DK-2100, Denmark.'}, {'ForeName': 'Niels Banhos', 'Initials': 'NB', 'LastName': 'Danneskiold-Samsøe', 'Affiliation': 'Laboratory of Genomics and Molecular Biomedicine, Department of Biology, University of Copenhagen, Copenhagen DK-2100, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hoffmann', 'Affiliation': 'School of Pharmaceutical Sciences, University of São Paulo, São Paulo 05508-000, Brazil.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'de Melo Iaucci', 'Affiliation': 'School of Pharmaceutical Sciences, University of São Paulo, São Paulo 05508-000, Brazil.'}, {'ForeName': 'Vanessa Pereira', 'Initials': 'VP', 'LastName': 'Cabral', 'Affiliation': 'School of Pharmaceutical Sciences, University of São Paulo, São Paulo 05508-000, Brazil.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Xavier-Santos', 'Affiliation': 'School of Pharmaceutical Sciences, University of São Paulo, São Paulo 05508-000, Brazil.'}, {'ForeName': 'Carla Romano', 'Initials': 'CR', 'LastName': 'Taddei', 'Affiliation': 'School of Pharmaceutical Sciences, University of São Paulo, São Paulo 05508-000, Brazil.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Kristiansen', 'Affiliation': 'Laboratory of Genomics and Molecular Biomedicine, Department of Biology, University of Copenhagen, Copenhagen DK-2100, Denmark.'}, {'ForeName': 'Susana Marta Isay', 'Initials': 'SMI', 'LastName': 'Saad', 'Affiliation': 'School of Pharmaceutical Sciences, University of São Paulo, São Paulo 05508-000, Brazil.'}]",Nutrients,['10.3390/nu12041081']
554,31320177,The association of serum interleukin-6 levels with clinical outcomes in antineutrophil cytoplasmic antibody-associated vasculitis.,"OBJECTIVE


To investigate serum IL-6 (sIL-6) levels during active disease, complete remission (CR), and relapse in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), and to explore the association of changes in sIL-6 with clinical outcomes.
METHODS


sIL-6 levels were measured at baseline and longitudinally over 18 months, in 78 patients with AAV enrolled in a randomized controlled trial comparing treatment with either rituximab (RTX) or cyclophosphamide (CYC)/azathioprine (AZA). Outcome variables included baseline clinical features, ANCA specificity, disease activity (active disease versus CR), time to relapse events, B cell repopulation, and ANCA titer increases.
RESULTS


At baseline, sIL6 levels were detectable in 81% of patients; 73% (n = 57) of subjects were proteinase 3 (PR3)-ANCA positive, sIL-6 levels were higher in subjects with PR3-ANCAs and positively correlated with their levels (r s  = 0.36,p < 0.01), but not with levels of myeloperoxidase (MPO)-ANCA (r s  = -0.17,p = 0.47). Higher baseline sIL-6 levels were associated with PR3-ANCA positivity, fever, pulmonary nodules/cavities, conductive deafness, and absence of urinary red blood cell casts (p < 0.05). Baseline sIL6 levels did not predict CR at month 6 (p = 0.71), and the median sIL-6 level declined from baseline with induction therapy, regardless of CR achievement. An increase in sIL-6 during CR was a predictor for subsequent severe relapse in RTX-treated patients (hazard ratio (HR):7.24,p = 0.01), but not in CYC/AZA-treated patients (HR:0.62,p = 0.50). In contrast, a sIL-6 increase did not predict B cell repopulation or ANCA titer increase in either treatment arm (p > 0.05).
CONCLUSION


At baseline, sIL-6 concentrations correlate with PR3-ANCA titers and are associated with specific clinical manifestations of AAV. Baseline sIL6 concentrations do not predict CR at 6 months, but the increase in sIL-6 concentrations during CR is associated with subsequent severe relapse among RTX-treated patients. Further investigation into the mechanistic role of IL6 in AAV might lead to identifying this pathway as a potential therapeutic target in this disease.",2019,"(PR3)-ANCA positive, sIL-6 levels were higher in subjects with PR3-ANCAs and positively correlated with their levels (r s  = 0.36,p < 0.01), but not with levels of myeloperoxidase (MPO)-ANCA (r s  = -0.17,p = 0.47).",['78 patients with AAV enrolled'],['rituximab (RTX) or cyclophosphamide (CYC)/azathioprine (AZA'],"['PR3-ANCA positivity, fever, pulmonary nodules/cavities, conductive deafness, and absence of urinary red blood cell casts', 'baseline clinical features, ANCA specificity, disease activity (active disease versus CR), time to relapse events, B cell repopulation, and ANCA titer increases', 'sIL-6 increase did not predict B cell repopulation or ANCA titer increase', 'sIL6 levels', 'Baseline sIL6 concentrations', 'sIL-6', 'serum IL-6', 'Higher baseline sIL-6 levels', 'sIL-6 concentrations', 'Baseline sIL6 levels', 'sIL-6) levels during active disease, complete remission (CR), and relapse in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV', 'median sIL-6 level', 'PR3)-ANCA positive, sIL-6 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0201530', 'cui_str': 'Antineutrophil cytoplasmic antibody measurement (procedure)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0018777', 'cui_str': 'Conductive hearing loss (disorder)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0333873', 'cui_str': 'Squamous intraepithelial lesion'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2609436', 'cui_str': 'Vasculitis (SMQ)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0238874', 'cui_str': 'Antineutrophil cytoplasmic antibody positive (finding)'}]",78.0,0.149311,"(PR3)-ANCA positive, sIL-6 levels were higher in subjects with PR3-ANCAs and positively correlated with their levels (r s  = 0.36,p < 0.01), but not with levels of myeloperoxidase (MPO)-ANCA (r s  = -0.17,p = 0.47).","[{'ForeName': 'Alvise', 'Initials': 'A', 'LastName': 'Berti', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Roscoe', 'Initials': 'R', 'LastName': 'Warner', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Divi', 'Initials': 'D', 'LastName': 'Cornec', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Darrell R', 'Initials': 'DR', 'LastName': 'Schroeder', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Brian F', 'Initials': 'BF', 'LastName': 'Kabat', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Langford', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Cees G M', 'Initials': 'CGM', 'LastName': 'Kallenberg', 'Affiliation': 'University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Seo', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Spiera', 'Affiliation': 'Hospital for Special Surgery, New York, NY, USA.'}, {'ForeName': 'E William', 'Initials': 'EW', 'LastName': 'St Clair', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Fernando C', 'Initials': 'FC', 'LastName': 'Fervenza', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Stone', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Monach', 'Affiliation': 'Boston University and VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA. Electronic address: specks.ulrich@mayo.edu.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of autoimmunity,['10.1016/j.jaut.2019.07.001']
555,32294534,Reducing Missed Opportunities for Human Papillomavirus Vaccination in School-Based Health Centers: Impact of an Intervention.,"OBJECTIVE


Human papillomavirus (HPV) immunization rates among US adolescents are low. Missed opportunities (MOs) for HPV vaccination are common. School-based health centers (SBHCs) have potential to boost HPV vaccination, but their role in addressing MOs has not been examined.
METHODS


We implemented a multicomponent intervention, consisting of 3 immunization process workflow modifications combined with provider performance feedback, in 2 Los Angeles area SBHCs and conducted a pre/post evaluation of MOs. Our primary outcome was SBHC-based MOs for HPV vaccination during all visits, including visits for confidential reproductive health care (ie, confidential visits). Secondary outcomes were MOs for meningococcal (MenACWY) and influenza vaccination during visits for nonconfidential care.
RESULTS


MOs for HPV vaccination decreased during all visit types from the baseline to the intervention period (82.3% to 46.1%; adjusted risk ratio [RR] = 0.558, P < .0001). The rate decrease appeared to be greater during physical examination visits than confidential visits (83.4% to 31.6% vs 98.7% to 70.4%, respectively). MOs for MenACWY (74.5% to 35.0%; adjusted RR = 0.47, P < .0001) and influenza (86.7% to 69.3%; adjusted RR = 0.792, P < .0001) vaccination also decreased during nonconfidential visits. Vaccine refusal was the most frequently documented reason for HPV vaccine MOs during both physical examination and confidential visits.
CONCLUSIONS


A pragmatic, multicomponent SBHC intervention reduced MOs for HPV vaccination during all visit types. MOs for MenACWY and influenza vaccination also decreased during nonconfidential visits. Findings suggest that practice-level improvements in SBHCs can improve delivery of HPV and other adolescent vaccines.",2020,"The rate decrease appeared to be greater during physical examination visits than confidential visits (83.4% to 31.6% vs. 98.7% to 70.4%, respectively).",['Human Papillomavirus Vaccination in School-Based Health Centers'],[],"['MOs for MenACWY and influenza vaccination', 'MOs for HPV vaccination', 'MOs for meningococcal (MenACWY) and influenza vaccination during visits for non-confidential care', 'HPV vaccination', 'SBHC-based MOs for HPV vaccination during all visits, including visits for confidential reproductive health care (i.e., confidential visits']","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]",[],"[{'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}]",,0.0638702,"The rate decrease appeared to be greater during physical examination visits than confidential visits (83.4% to 31.6% vs. 98.7% to 70.4%, respectively).","[{'ForeName': 'Megha D', 'Initials': 'MD', 'LastName': 'Shah', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, David Geffen School of Medicine and UCLA Mattel Children's Hospital (University of California, Los Angeles) (MD Shah, PJ Chung, R Valderrama, and PG Szilagyi), Los Angeles, Calif. Electronic address: mshah@ph.lacounty.gov.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Glenn', 'Affiliation': 'UCLA Kaiser Permanente Center for Health Equity (BA Glenn and LC Chang), Los Angeles, Calif; Jonsson Comprehensive Cancer Center at UCLA (BA Glenn and LC Chang), Los Angeles, Calif; Department of Health Policy and Management, UCLA Fielding School of Public Health (BA Glenn), Los Angeles, Calif.'}, {'ForeName': 'L Cindy', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'UCLA Kaiser Permanente Center for Health Equity (BA Glenn and LC Chang), Los Angeles, Calif; Jonsson Comprehensive Cancer Center at UCLA (BA Glenn and LC Chang), Los Angeles, Calif.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Chung', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, David Geffen School of Medicine and UCLA Mattel Children's Hospital (University of California, Los Angeles) (MD Shah, PJ Chung, R Valderrama, and PG Szilagyi), Los Angeles, Calif.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Valderrama', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, David Geffen School of Medicine and UCLA Mattel Children's Hospital (University of California, Los Angeles) (MD Shah, PJ Chung, R Valderrama, and PG Szilagyi), Los Angeles, Calif.""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Uyeda', 'Affiliation': 'Los Angeles Unified School District (K Uyeda), Los Angeles, Calif. Dr Shah is now with the Los Angeles County Department of Public Health, Office of Health Assessment and Epidemiology, Los Angeles, Calif. Dr Chung is now with the Department of Health Systems Science, Kaiser Permanente School of Medicine, Pasadena, Calif. Dr Uyeda is now with the California School-Based Health Alliance, Oakland, Calif.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Szilagyi', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, David Geffen School of Medicine and UCLA Mattel Children's Hospital (University of California, Los Angeles) (MD Shah, PJ Chung, R Valderrama, and PG Szilagyi), Los Angeles, Calif.""}]",Academic pediatrics,['10.1016/j.acap.2020.04.002']
556,32294874,[Application of external diaphragm pacemaker combination with high-flow nasal cannula in offline patients with postoperative severe cerebral hemorrhage].,"Objective:  To investigate the offline clinical effect of external diaphragm pacemaker (EDP) combination with High-flow nasal cannula oxygen therapy in postoperative severe cerebral hemorrhage patients.  Methods:  A total of 123 severe postoperative severe cerebral hemorrhage patients with tracheotomy and mechanical ventilation (MV) were selected, who were admitted in NICU of PLA Rocket Force Characteristic Medical Center from October 2016 to December 2019. These patients were randomly divided into the High-flow nasal cannula (HFNC) group ( n= 63) and HFNC+EDP group ( n= 60). In the HFNC group, the HFNC was given to the patients who were off ventilator. The HFNC+EDP group was added on the basis of treatment in the HFNC group, once a day and 30 minutes each time.  Results:  Compared to the HFNC group, the oxygenation index (OI) of the HFNC+EDP group was higher in the next 1, 12, 24 and 48 hour [(209±15) mmHg vs (218±18) mmHg, (215±14) mmHg vs (222±17) mmHg, (223±13) mmHg vs (235±15) mmHg, (236±7) mmHg vs (257±12) mmHg, P< 0.05]. The offline time was shorter [(13±3) d vs (12±3) d, P< 0.05]. The excursion of diaphragm was higher [(1.94±0.08) cm vs (2.91±0.11) cm, P< 0.05]. The length of stay in NICU was shorter [(33±14) d vs (28±9) d, P< 0.05]. The Glasgow Coma Scale (GCS) was higher when being discharged from the NICU (5.9±2.1 vs 7.8±0.4,  P< 0.05) and the hospital (9.9±2.1 vs 11.0±2.0,  P< 0.05).  Conclusions:  EDP combination with HFNC can increase the excursion of diaphragm, shorten the offline time and length of stay in the NICU, thereby enhancing the early recovery and improving the prognosis.",2020,"Compared to the HFNC group, the oxygenation index (OI) of the HFNC+EDP group was higher in the next 1, 12, 24 and 48 hour [(209±15) mmHg vs (218±18)","['offline patients with postoperative severe cerebral hemorrhage', '123 severe postoperative severe cerebral hemorrhage patients with tracheotomy and mechanical ventilation (MV) were selected, who were admitted in NICU of PLA Rocket Force Characteristic Medical Center from October 2016 to December 2019', 'postoperative severe cerebral hemorrhage patients']","['High-flow nasal cannula (HFNC', 'HFNC+EDP', 'external diaphragm pacemaker combination with high-flow nasal cannula', 'HFNC', 'external diaphragm pacemaker (EDP) combination with High-flow nasal cannula oxygen therapy']","['excursion of diaphragm, shorten the offline time and length of stay', 'Glasgow Coma Scale (GCS', 'length of stay in NICU', 'oxygenation index (OI', 'excursion of diaphragm']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C4761117', 'cui_str': 'High-flow nasal cannula oxygen therapy'}]","[{'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}]",,0.029299,"Compared to the HFNC group, the oxygenation index (OI) of the HFNC+EDP group was higher in the next 1, 12, 24 and 48 hour [(209±15) mmHg vs (218±18)","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Jin Zhou Medical University PLA Rocket Force Characterristic Medical Center Graduate Training Base, Beijing 100088, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'PLA Rocket Force Characterristic Medical Center, Beijing 100088, China.'}, {'ForeName': 'Y F', 'Initials': 'YF', 'LastName': 'Liu', 'Affiliation': 'PLA Rocket Force Characterristic Medical Center, Beijing 100088, China.'}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Zhao', 'Affiliation': 'PLA Rocket Force Characterristic Medical Center, Beijing 100088, China.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Zhang', 'Affiliation': 'PLA Rocket Force Characterristic Medical Center, Beijing 100088, China.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Yin', 'Affiliation': 'PLA Rocket Force Characterristic Medical Center, Beijing 100088, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200217-00307']
557,32294881,"Health Outcomes of an Integrated Behaviour-Centred Water, Sanitation, Hygiene and Food Safety Intervention-A Randomised before and after Trial.","Diarrhoeal disease in children under five in low income settings has been associated with multiple environmental exposure pathways, including complementary foods. Conducted from February to December 2018 in rural Malawi, this before and after trial with a control used diarrhoeal disease as a primary outcome, to measure the impact of a food hygiene intervention (food hygiene + handwashing) relative to a food hygiene and water, sanitation and hygiene (WASH) intervention (food hygiene + handwashing + faeces management + water management). The 31-week intervention was delivered by community-based coordinators through community events ( n  = 2), cluster group meetings ( n  = 17) and household visits ( n  = 14). Diarrhoeal disease was self-reported and measured through an end line survey, and daily diaries completed by caregivers. Difference-in-differences results show a 13-percentage point reduction in self-reported diarrhoea compared to the control group. There were also significant increases in the presence of proxy measures in each of the treatment groups (e.g., the presence of soap). We conclude that food hygiene interventions (including hand washing with soap) can significantly reduce diarrhoeal disease prevalence in children under five years in a low-income setting. Therefore, the promotion of food hygiene practices using a behaviour-centred approach should be embedded in nutrition and WASH policies and programming.",2020,Difference-in-differences results show a 13-percentage point reduction in self-reported diarrhoea compared to the control group.,"['children under five in low income settings', 'children under five years in a low-income setting']","['food hygiene interventions (including hand washing with soap', 'food hygiene intervention (food hygiene + handwashing) relative to a food hygiene and water, sanitation and hygiene (WASH) intervention (food hygiene + handwashing + faeces management + water management', 'Integrated Behaviour-Centred Water, Sanitation, Hygiene and Food Safety']","['self-reported diarrhoea', 'Diarrhoeal disease', 'presence of proxy measures', 'diarrhoeal disease prevalence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1456535', 'cui_str': 'Food Safety'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",,0.0252993,Difference-in-differences results show a 13-percentage point reduction in self-reported diarrhoea compared to the control group.,"[{'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Morse', 'Affiliation': 'Centre for Water, Environment, Sustainability and Public Health, Department of Civil and Environmental Engineering, University of Strathclyde, Glasgow G1 1XJ, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tilley', 'Affiliation': 'Department of Environmental Health, University of Malawi (Polytechnic), Blantyre, Malawi.'}, {'ForeName': 'Kondwani', 'Initials': 'K', 'LastName': 'Chidziwisano', 'Affiliation': 'Centre for Water, Environment, Sustainability and Public Health, Department of Civil and Environmental Engineering, University of Strathclyde, Glasgow G1 1XJ, UK.'}, {'ForeName': 'Rossanie', 'Initials': 'R', 'LastName': 'Malolo', 'Affiliation': 'Centre for Water, Sanitation, Health and Appropriate Technology Development (WASHTED), University of Malawi (Polytechnic), Blantyre, Malawi.'}, {'ForeName': 'Janelisa', 'Initials': 'J', 'LastName': 'Musaya', 'Affiliation': 'Department of Biochemical Sciences, College of Medicine, University of Malawi, Blantyre, Malawi.'}]",International journal of environmental research and public health,['10.3390/ijerph17082648']
558,32294883,"Administration of Apple Polyphenol Supplements for Skin Conditions in Healthy Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","This clinical study was performed to evaluate the effects of continuous apple polyphenol (AP) administration on facial skin conditions and pigmentation induced by ultraviolet (UV) irradiation in healthy women participants. Participants (n = 65, age 20-39 years) were randomized to receive tablets containing AP (300 or 600 mg/day) or placebo in a double-blinded, placebo-controlled clinical trial. Continuous administration of AP for 12 weeks significantly prevented UV irradiation induced skin pigmentation (erythema value, melanin value, L value), although a dose-dependent relationship was not clearly observed. In contrast, no significant differences were detected between the groups with regard to water content and trans-epidermal water loss. Our study demonstrated that APs and their major active compounds, procyanidins, have several health benefits. Here, we report that continuous administration of AP for 12 weeks alleviated UV irradiation induced skin pigmentation, when compared with placebo, in healthy women.",2020,"Continuous administration of AP for 12 weeks significantly prevented UV irradiation induced skin pigmentation (erythema value, melanin value, L value), although a dose-dependent relationship was not clearly observed.","['healthy women', 'Healthy Women', 'Participants (n = 65, age 20-39 years', 'healthy women participants']","['continuous apple polyphenol (AP', 'Apple Polyphenol Supplements', 'placebo', 'Placebo', 'tablets containing AP']","['water content and trans-epidermal water loss', 'UV irradiation induced skin pigmentation (erythema value, melanin value, L value', 'facial skin conditions and pigmentation induced by ultraviolet (UV) irradiation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037290', 'cui_str': 'Skin pigmentation'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}]",,0.340781,"Continuous administration of AP for 12 weeks significantly prevented UV irradiation induced skin pigmentation (erythema value, melanin value, L value), although a dose-dependent relationship was not clearly observed.","[{'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Shoji', 'Affiliation': 'Research Laboratories for Fundamental Technology of Food, Asahi Breweries Ltd., 1-21 Midori 1-chome, Moriya-shi, Ibaraki 305-0106, Japan.'}, {'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Masumoto', 'Affiliation': 'Research Laboratories for Fundamental Technology of Food, Asahi Breweries Ltd., 1-21 Midori 1-chome, Moriya-shi, Ibaraki 305-0106, Japan.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Moriichi', 'Affiliation': 'Research Laboratories for Fundamental Technology of Food, Asahi Breweries Ltd., 1-21 Midori 1-chome, Moriya-shi, Ibaraki 305-0106, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Ohtake', 'Affiliation': 'Research Laboratories for Fundamental Technology of Food, Asahi Breweries Ltd., 1-21 Midori 1-chome, Moriya-shi, Ibaraki 305-0106, Japan.'}, {'ForeName': 'Tomomasa', 'Initials': 'T', 'LastName': 'Kanda', 'Affiliation': 'Research Laboratories for Fundamental Technology of Food, Asahi Breweries Ltd., 1-21 Midori 1-chome, Moriya-shi, Ibaraki 305-0106, Japan.'}]",Nutrients,['10.3390/nu12041071']
559,31736283,How can we best use opportunities provided by routine maternity care to engage women in improving their diets and health?,"Pregnancy provides motivation for women to improve their diets and increase their physical activity. Opportunistic brief interventions delivered as part of routine primary care have produced improvements in patients' health behaviour. Consequently, there have been calls for midwives to use contacts during pregnancy in this way. This study explored the experiences of pregnant women and research midwives/nurses of a brief intervention called Healthy Conversation Skills (HCS) being delivered as part of a randomised control trial, assessing the acceptability and feasibility of including this intervention in routine maternity care. Three research questions were addressed using mixed methods to produce four datasets: face-to-face interviews with participants, a focus group with the HCS-trained midwives/nurses, case reports of participants receiving HCS and audio-recordings of mid-pregnancy telephone calls to the women which produced midwife/nurse HCS competency scores. Midwives/nurses used their HCS to support women to make plans for change and set goals. Women welcomed the opportunity to address their own health and well-being as distinct from that of their baby. Midwives/nurses were competent in using the skills and saw healthy conversations as an effective means of raising issues of diet and physical activity. Recent extension of maternity appointment times provides ideal opportunities to incorporate a brief intervention to support behaviour change. Incorporating HCS training into midwifery education and continuing professional development would facilitate this. HCS is a scalable, brief intervention with the potential to improve the diets and physical activity levels of women during pregnancy, and hence the health of themselves and their babies.",2020,Midwives/nurses were competent in using the skills and saw healthy conversations as an effective means of raising issues of diet and physical activity.,"[""patients' health behaviour"", 'pregnant women and research midwives/nurses of a']","['HCS and audio-recordings of mid-pregnancy telephone calls to the women which produced midwife/nurse HCS competency scores', 'HCS', 'brief intervention called Healthy Conversation Skills (HCS']",['physical activity'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0035168'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0191824,Midwives/nurses were competent in using the skills and saw healthy conversations as an effective means of raising issues of diet and physical activity.,"[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lawrence', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Vogel', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Strömmer', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Morris', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Treadgold', 'Affiliation': 'School of Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Watson', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hart', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McGill', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hammond', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Harvey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Inskip', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Baird', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Barker', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}]",Maternal & child nutrition,['10.1111/mcn.12900']
560,32294870,[The clinical efficacy of laparoscopic cornuotomy on interstitial tubal pregnancy which diameter was shorter than 3 cm].,"Objective:  To investigate the clinical efficacy of Laparoscopic cornuotomy on Interstitial Tubal Pregnancy (IP) which diameter was shorter than 3 cm.  Methods:  The women who had IP under 3 cm diameter were selected from January, 2016 to December, 2018 at the Department of Gynecology, JiaXing Maternity and Child Health care Hospital. A total of 32 IP patients were divided into two groups. They were all treated with laparoscopic surgery. 17 patients were in study group, conducted by a cornuotomy and suturing the cornual.15 patients were in control group, conducted by a cornual resection and suturing the cornual. Patients' genenral conditions were not significantly different(all  P  values>0.05). The peri-surgical data and the related clinical data were compared in the two groups.  Results:  All the 32 patients were successfully treated by laparoscopic surgery. The mean operating time was significantly shorter for cornuotomy than for cornual resection[ (33±6) min vs (53±9) min,  P< 0.05].Changes in blood loss[(45±5) ml vs (50±7) ml]、the total hospital stays[ (4.4±1.4) d vs (4.6±1.4) d] and the recovery time of HCG[(16±5) d vs (15±5) d] were not significantly different between the two groups (all  P  values>0.05) . There were no persistent ectopic pregnancy and uterine rupture happened in two groups. Compared with the control group,the interval time to pregnancy was shorter[ (8±3) m vs (16±4) m,  P< 0.05] and the number of full-term pregnancy cases were more (9 vs 3,  P< 0.05).  Conclusion:  The Laparoscopic cornuotomy was feasible and safe on interstitial tubal pregnancy which diameter was shorter than 3cm. It deserved popularization in the clinical work and regarded as one of selection operative treatment on interstitial heterotopic pregnancy.",2020,Patients' genenral conditions were not significantly different(all  P  values>0.05).,"['32 patients were successfully treated by laparoscopic surgery', 'A total of 32 IP patients', '17 patients', 'women who had IP under 3 cm diameter were selected from January, 2016 to December, 2018 at the Department of Gynecology, JiaXing Maternity and Child Health care Hospital']","['laparoscopic surgery', 'laparoscopic cornuotomy', 'Laparoscopic cornuotomy', 'cornual resection and suturing the cornual']","['ectopic pregnancy and uterine rupture', 'recovery time of HCG[(16±5', 'interstitial tubal pregnancy', 'Interstitial Tubal Pregnancy (IP', 'mean operating time', 'number of full-term pregnancy cases', 'ml]、the total hospital stays', 'interval time to pregnancy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0032987', 'cui_str': 'Ectopic pregnancy'}, {'cui': 'C0042143', 'cui_str': 'Rupture of uterus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0032994', 'cui_str': 'Tubal pregnancy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3494204', 'cui_str': 'Time-to-Pregnancy'}]",32.0,0.0192718,Patients' genenral conditions were not significantly different(all  P  values>0.05).,"[{'ForeName': 'Q Y', 'Initials': 'QY', 'LastName': 'Jin', 'Affiliation': 'Department of Obstetrics and Gynecology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou 310000, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Jin', 'Affiliation': 'Department of Gynecology, Jiaxing Maternity and Child Health care Hospital, Jiaxing 314051, China.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou 310000, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20191122-02547']
561,31711300,Household Water Quality Testing and Information: Identifying Impacts on Health Outcomes and Sanitation- and Hygiene-Related Risk-Mitigating Behaviors.,"BACKGROUND


In 2014, a group of 512 households in multipurpose water systems and also relying on unimproved water, sanitation, and hygiene practices in the Greater Accra region of Ghana were randomly selected to participate in water quality self-testing and also receipt of information in the form of handouts on how to improve water quality.
OBJECTIVES AND RESEARCH DESIGN


Using a cluster-randomized controlled design, we study the health, sanitation, and hygiene behavior impacts of the household water quality testing and information experiment.
SUBJECTS


The study has three arms: (1) adult household members, (2) schoolgoing children, and (3) control group.
MEASURES


The study measures the effects on handwashing with soap, cleanliness of households, and prevalence of diarrhea and self-reported fever. We also address impacts on child health and nutrition outcomes, particularly diarrhea and anthropometric outcomes.
RESULTS


We show that there is high household willingness to participate in this intervention on water quality self-testing. About 7 months after households took part in the intervention, the study finds little impacts on health outcomes and on sanitation- and hygiene-related risk-mitigating behaviors, regardless of the intervention group, either schoolchildren or adult household members. Impacts (direction and extent) are rather homogeneous for most of the outcomes across treatment groups.
CONCLUSIONS


The study discusses the implications of the findings and also offers several explanations for the lack of transmission of impacts from the household water quality testing and information intervention on health outcomes and on sanitation and hygiene behaviors.",2019,"About 7 months after households took part in the intervention, the study finds little impacts on health outcomes and on sanitation- and hygiene-related risk-mitigating behaviors, regardless of the intervention group, either schoolchildren or adult household members.","['adult household members, (2) schoolgoing children, and (3) control group', '512 households in multipurpose water systems and also relying on unimproved water, sanitation, and hygiene practices in the Greater Accra region of Ghana']",[],"['child health and nutrition outcomes, particularly diarrhea and anthropometric outcomes', 'handwashing with soap, cleanliness of households, and prevalence of diarrhea and self-reported fever']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}]",[],"[{'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}]",,0.0231326,"About 7 months after households took part in the intervention, the study finds little impacts on health outcomes and on sanitation- and hygiene-related risk-mitigating behaviors, regardless of the intervention group, either schoolchildren or adult household members.","[{'ForeName': 'Charles Yaw', 'Initials': 'CY', 'LastName': 'Okyere', 'Affiliation': 'Department of Agricultural Economics and Agribusiness, College of Basic and Applied Sciences, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Evita Hanie', 'Initials': 'EH', 'LastName': 'Pangaribowo', 'Affiliation': 'Faculty of Geography, Department of Environmental Geography, Gadjah Mada University, Yogyakarta, Indonesia.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Gerber', 'Affiliation': 'Center for Development Research (ZEF), University of Bonn, Germany.'}]",Evaluation review,['10.1177/0193841X19885204']
562,32295808,Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial.,"OBJECTIVE


To assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naive Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).
RESEARCH DESIGN AND METHODS


In this phase 3, open-label, multicenter trial, 321 patients with HbA 1c ≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks. The primary end point was change in HbA 1c  at week 26.
RESULTS


Change in HbA 1c  from baseline to week 26 was significantly greater with iGlarLixi (-1.58% [-17.3 mmol/mol]) than with Lixi (-0.51% [-5.6 mmol/mol]), confirming the superiority of iGlarLixi (least squares [LS] mean difference -1.07% [-11.7 mmol/mol],  P  < 0.0001). At week 26, significantly greater proportions of patients treated with iGlarLixi reached HbA 1c  <7% (53 mmol/mol) (65.2% vs. 19.4%;  P  < 0.0001), and FPG reductions were greater with iGlarLixi than Lixi (LS mean difference -2.29 mmol/L [-41.23 mg/dL],  P  < 0.0001). Incidence of documented symptomatic hypoglycemia (≤3.9 mmol/L [70 mg/dL]) was higher with iGlarLixi (13.0% vs. 2.5%) through week 26, with no severe hypoglycemic events in either group. Incidence of gastrointestinal events through week 52 was lower with iGlarLixi (36.0% vs. 50.0%), and rates of treatment-emergent adverse events were similar.
CONCLUSIONS


This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.",2020,"This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.","['Japanese patients with T2DM', 'insulin-naïve Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs', 'Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs', '321 patients with HbA 1c ≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL']","['1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide', 'iGlarLixi or Lixi', 'insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi', 'iGlarLixi']","['Efficacy and Safety', 'FPG reductions', 'change in HbA 1c', 'rates of treatment-emergent adverse events', 'Incidence of documented symptomatic hypoglycemia', 'efficacy and safety', 'severe hypoglycemic events', 'Incidence of gastrointestinal events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4293375', 'cui_str': 'insulin glargine and lixisenatide'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",321.0,0.0516409,"This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan hwatada@juntendo.ac.jp.'}, {'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Takami', 'Affiliation': 'Research & Development, Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spranger', 'Affiliation': 'Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Amano', 'Affiliation': 'Research & Development, Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Research & Development, Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}]",Diabetes care,['10.2337/dc19-2452']
563,32295131,"Effects of a Psychological Management Program on Subjective Happiness, Anger Control Ability, and Gratitude among Late Adolescent Males in Korea.","This study aimed to develop an emotion management program for late adolescent males, and investigate the effect of the program. This study is an experimental study using a pretest-posttest control group design. It was conducted from 14 May to 21 December, 2018 at a male high school in Korea. It analyzed 52 participants (26 in the experimental group and 26 in the control group.) Regarding subjective happiness, there was a significant difference between groups (t = 3.409,  p  = 0.001). In anger control ability and gratitude, there was no significant difference between groups (t = 0.332,  p  = 0.740/ z = 0.528,  p  = 0.599). This program for emotion management, which is based on the broaden-and-build theory, can improve subjective happiness, anger control ability, and gratitude, by reinforcing appreciation skills and anger awareness and self-expression in male high school students.",2020,"In anger control ability and gratitude, there was no significant difference between groups (t = 0.332,  p  = 0.740/","['14 May to 21 December, 2018 at a male high school in Korea', 'late adolescent males', '52 participants (26 in the experimental group and 26 in the control group', 'male high school students', 'Late Adolescent Males in Korea']","['emotion management program', 'Psychological Management Program']","['Subjective Happiness, Anger Control Ability, and Gratitude', 'subjective happiness']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0120727,"In anger control ability and gratitude, there was no significant difference between groups (t = 0.332,  p  = 0.740/","[{'ForeName': 'Ju Eun', 'Initials': 'JE', 'LastName': 'Hong', 'Affiliation': 'Department of Nursing, Dongyang University, Yeongju 36040, Korea.'}, {'ForeName': 'Miok', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, College of Nursing, Dankook University, Cheonan 31116, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17082683']
564,32132224,Effect of fingolimod on MRI outcomes in patients with paediatric-onset multiple sclerosis: results from the phase 3 PARADIG MS  study.,"OBJECTIVE


PARADIG MS  demonstrated superior efficacy and comparable safety of fingolimod versus interferon β-1a (IFN β-1a) in paediatric-onset multiple sclerosis (PoMS). This study aimed to report all predefined MRI outcomes from this study.
METHODS


Patients with multiple sclerosis (MS) (aged 10-<18 years) were randomised to once-daily oral fingolimod (n=107) or once-weekly intramuscular IFN β-1a (n=108) in this flexible duration study. MRI was performed at baseline and every 6 months for up to 2 years or end of the study (EOS) in case of early treatment discontinuation/completion. Key MRI endpoints included the annualised rate of formation of new/newly enlarging T2 lesions, gadolinium-enhancing (Gd+) T1 lesions, new T1 hypointense lesions and combined unique active (CUA) lesions (6 months onward), changes in T2 and Gd+ T1 lesion volumes and annualised rate of brain atrophy (ARBA).
RESULTS


Of the randomised patients, 107 each were treated with fingolimod and IFN β-1a for up to 2 years. Fingolimod reduced the annualised rate of formation of new/newly enlarging T2 lesions (52.6%, p<0.001), number of Gd+ T1 lesions per scan (66.0%, p<0.001), annualised rate of new T1 hypointense lesions (62.8%, p<0.001) and CUA lesions per scan (60.7%, p<0.001) versus IFN β-1a at EOS. The percent increases from baseline in T2 (18.4% vs 32.4%, p<0.001) and Gd+ T1 (-72.3% vs 4.9%, p=0.001) lesion volumes and ARBA (-0.48% vs -0.80%, p=0.014) were lower with fingolimod versus IFN β-1a, the latter partially due to accelerated atrophy in the IFN β-1a group.
CONCLUSION


Fingolimod significantly reduced MRI activity and ARBA for up to 2 years versus IFN β-1a in PoMS.",2020,Fingolimod significantly reduced MRI activity and ARBA for up to 2 years versus IFN β-1a in PoMS.,"['patients with paediatric-onset multiple sclerosis', 'paediatric-onset multiple sclerosis (PoMS', 'Patients with multiple sclerosis (MS) (aged 10-<18 years']","['fingolimod', 'fingolimod versus interferon β-1a (IFN β-1a', 'oral fingolimod (n=107) or once-weekly intramuscular IFN β-1a']","['number of Gd+ T1 lesions per scan', 'MRI activity and ARBA', 'MRI outcomes', 'annualised rate of formation of new/newly enlarging T2 lesions, gadolinium-enhancing (Gd+) T1 lesions, new T1 hypointense lesions and combined unique active (CUA) lesions (6 months onward), changes in T2 and Gd+ T1 lesion volumes and annualised rate of brain atrophy (ARBA', 'annualised rate of formation of new/newly enlarging T2 lesions', 'lesion volumes and ARBA', 'annualised rate of new T1 hypointense lesions', 'Gd+ T1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0441633'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0442800', 'cui_str': 'Enlarged (qualifier value)'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}]",,0.057622,Fingolimod significantly reduced MRI activity and ARBA for up to 2 years versus IFN β-1a in PoMS.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada douglas.arnold@mcgill.ca.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Banwell', 'Affiliation': ""The Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bar-Or', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadephia, Pennsylvania, USA, Montreal, Quebec, Canada.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Ghezzi', 'Affiliation': 'Centro Studi Sclerosi Multipla, Ospedale di Gallarate, Gallarate, Italy.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Greenberg', 'Affiliation': 'Department of Neurology and Neurotherapeutics, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Waubant', 'Affiliation': 'Department of Neurology, University of California, San Francisco, California, USA.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University, London, UK.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'McGovern Medical School, Department of Neurology, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA, Houston, Texas, USA.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Gärtner', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, German Centre for Multiple Sclerosis in Childhood and Adolescence, University Medical Centre, Göttingen, Germany.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Rostásy', 'Affiliation': ""Division of Paediatric Neurology, Children's Hospital Datteln, University Witten/Herdecke, Datteln, Germany.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Krupp', 'Affiliation': 'Department of Neurology; Pediatric MS Center, NYU Langone Health, New York, NY USA, USA, New York, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Tardieu', 'Affiliation': 'Hôpitaux universitaires Paris Sud, Paediatric Neurology Department, Assistance Publique-Hôpitaux de Paris, Paris France, Paris, France.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Brück', 'Affiliation': 'Department of Neuropathology, University Medical Centre, Göttingen, Germany.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Stites', 'Affiliation': 'Neuroscience TA, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Pearce', 'Affiliation': 'GCE Solutions, Bloomington, Illinois, USA.'}, {'ForeName': 'Dieter A', 'Initials': 'DA', 'LastName': 'Häring', 'Affiliation': 'Neuroscience TA, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Merschhemke', 'Affiliation': 'Neuroscience TA, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Tanuja', 'Initials': 'T', 'LastName': 'Chitnis', 'Affiliation': 'Partners Pediatric Multiple Sclerosis Center, Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-322138']
565,31981043,Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation in the Management of Weight Regain After Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.,"BACKGROUND


Roux-en-Y gastric bypass is one of the most widely performed bariatric surgeries. However, the relapse of obesity occurs in approximately 20% of patients and enlargement of the anastomosis is one of the factors associated with this relapse. Endoscopic treatment of the anastomosis has been proposed to assist in renewed weight loss. One endoscopic technique is the narrowing of the anastomosis argon plasma coagulation (APC).
OBJECTIVE


Evaluate the effectiveness and safety of the endoscopic treatment of an enlarged anastomosis with APC.
METHODS


A randomized controlled study was conducted comparing APC to exclusive multidisciplinary management after weight regain.
RESULTS


Forty-two patients were divided into two groups: APC (n = 22) and control (n = 20). After 14 months of follow-up with a crossover at 6 months, significant improvement in satiety and greater weight loss were found in the APC group and after crossover. APC was associated with significant weight loss [9.73 (7.46, 12) vs. + 1.38 (- 1.39, 2.15)], a reduction in the anastomosis diameter [p < 0.001], early satiation [0.77 (0.44, 1.11) vs. - 0.59 (- 0.95, - 0.23), p < 0.001], and increased quality of life measured using the EQ5D index [p = 0.04] and EQ5D VAS scale [p = 0.04]. Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
CONCLUSION


Treatment of the gastrojejunal anastomosis with APC was effective and safe, with significant weight loss, the return of early satiation, and an improvement in quality of life.",2020,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
","['After Gastric Bypass Surgery', 'Forty-two patients']","['Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation', 'APC', 'SHAM']","['quality of life', 'satiety and greater weight loss', 'weight loss', 'EQ5D VAS scale', 'effectiveness and safety', 'total mean weight loss', 'weight loss, the return of early satiation', 'relapse of obesity occurs', 'Weight Regain']","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1879736', 'cui_str': 'Argon Beam Coagulation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0034380'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0222045'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",42.0,0.0503247,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
","[{'ForeName': 'Luiz Gustavo', 'Initials': 'LG', 'LastName': 'de Quadros', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil. Gustavo_quadros@hotmail.com.'}, {'ForeName': 'Manoel Galvão', 'Initials': 'MG', 'LastName': 'Neto', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'João Caetano', 'Initials': 'JC', 'LastName': 'Marchesini', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Teixeira', 'Affiliation': 'Orlando Health Hospital, Orlando, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Grecco', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Roberto Luiz Kaiser', 'Initials': 'RLK', 'LastName': 'Junior', 'Affiliation': 'Beneficência Portuguesa Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Zundel', 'Affiliation': 'Jackson North Medical Center, University at Buffalo, Miami, USA.'}, {'ForeName': 'Idiberto José Zotarelli', 'Initials': 'IJZ', 'LastName': 'Filho', 'Affiliation': 'Kaiser Day Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Thiago Ferreira', 'Initials': 'TF', 'LastName': 'de Souza', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Admar Concon', 'Initials': 'AC', 'LastName': 'Filho', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Lyz Bezerra', 'Initials': 'LB', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Josemberg Marins', 'Initials': 'JM', 'LastName': 'Campos', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04414-6']
566,31942688,Weight Loss and Vomiting 1 Year After Banded Versus Non-banded One Anastomosis Gastric Bypass: a Prospective Randomized Trial.,"BACKGROUND


The weight loss outcomes after banded one-anastomosis gastric bypass (OAGB) remain to be determined.
OBJECTIVE


To compare weight loss and vomiting 1 year after banded versus non-banded OAGB.
METHODS


This is a prospective, open-label, randomized study, which evaluated 33 individuals with morbid obesity, which underwent banded (16 individuals) and non-banded OAGB (17 individuals) and were followed up for 12 months. Weight loss (percentages of total weight loss-%TWL-and excess weight loss-%EWL) and occurrence of vomiting were assessed and compared before surgery and after 6 and 12 months.
RESULTS


At baseline, there were no differences between groups in regard to age, gender, and body mass index (BMI). At 6 and 12 months post-op, and the overall mean %TWL regardless of band use was 22.4 ± 7% and 29 ± 6.9%, respectively, and the overall average %EWL regardless of band use was 66.8 ± 22.9% and 86.3 ± 24%, respectively. %TWL did not differ between the banded and non-banded groups at 6 (21.8 ± 6.8% vs. 23.1 ± 7.4%; p = 0.7) and 12 months post-op (27.5 ± 6.6% vs. 30.4 ± 7.1%; p = 0.3), as well as %EWL at 6 (67 ± 22.9% vs. 67.6 ± 23.6%; p = 0.6) and 12 months post-op (83.5 ± 24.4% vs. 89 ± 24.1%; p = 0.4). The occurrence of vomiting did not significantly differ between banded and non-banded OAGB at 6 (12.5% vs. 11.8%; p = 0.9) and 12 months post-op (12.5% vs. 5.9%; p = 0.5).
CONCLUSION


OAGB led to an overall satisfactory weight loss after 1 year, regardless of band use. Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.",2020,Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.,"['33 individuals with morbid obesity, which underwent banded (16 individuals) and non-banded OAGB (17 individuals) and were followed up for 12\xa0months']","['OAGB', 'Banded Versus Non-banded One Anastomosis Gastric Bypass']","['weight loss and vomiting 1\xa0year', 'overall satisfactory weight loss', 'weight loss nor more vomiting', 'Weight Loss and Vomiting 1 Year', 'occurrence of vomiting', 'Weight loss (percentages of total weight', 'loss-%TWL-and excess weight loss-%EWL) and occurrence of vomiting']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0252491,Banded OAGB did not lead to neither significantly higher weight loss nor more vomiting than non-banded OAGB 1 year after surgery.,"[{'ForeName': 'Everton', 'Initials': 'E', 'LastName': 'Cazzo', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil. notrevezzo@yahoo.com.'}, {'ForeName': 'Laísa Simakawa', 'Initials': 'LS', 'LastName': 'Jimenez', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Felipe Gilberto', 'Initials': 'FG', 'LastName': 'Valerini', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Tiago Bezerra', 'Initials': 'TB', 'LastName': 'de Freitas Diniz', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': 'Elinton Adami', 'Initials': 'EA', 'LastName': 'Chaim', 'Affiliation': 'Department of Surgery, Faculty of Medical Sciences, State University of Campinas (UNICAMP), São Paulo, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04393-8']
567,32087337,N-acetylcysteine for the treatment of comorbid alcohol use disorder and posttraumatic stress disorder: Design and methodology of a randomized clinical trial.,"Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) are two prevalent psychiatric conditions in the U.S. The co-occurrence of AUD and PTSD is also common, and associated with a more severe clinical presentation and worse treatment outcomes across the biopsychosocial spectrum (e.g., social and vocational functioning, physical health) as compared to either disorder alone. Despite the high co-occurrence and negative outcomes, research on effective medications for AUD/PTSD is sparse and there is little empirical evidence to guide treatment decisions. The study described in this paper addresses this knowledge gap by testing the efficacy of N-acetylcysteine (NAC) in reducing alcohol use and PTSD symptoms. Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation. NAC is a cysteine pro-drug that stimulates the cystine-glutamate exchanger, normalizes glial glutamate transporters, and restores glutamatergic tone on presynaptic receptors in reward regions of the brain. Moreover, NAC is available over-the-counter, has a long-established safety record, and does not require titration to achieve the target dose. This paper describes the rationale, study design, and methodology of a 12-week, randomized, double-blind, placebo-controlled trial of NAC (2400 mg/day) among adults with co-occurring AUD and PTSD. Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS) are utilized to investigate the neural circuitry and neurochemistry underlying comorbid AUD/PTSD and identify predictors of treatment outcome. This study is designed to determine the efficacy of NAC in the treatment of co-occurring AUD/PTSD and provide new information regarding mechanisms of action implicated in co-occurring AUD/PTSD.",2020,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"['adults with co-occurring AUD and PTSD', 'comorbid alcohol use disorder and posttraumatic stress disorder']","['placebo', 'NAC', 'N-acetylcysteine', 'Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS', 'N-acetylcysteine (NAC']",['alcohol use and PTSD symptoms'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0324161,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"[{'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: graykm@musc.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Santa Ana', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: santaana@musc.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jonjen@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jarnecka@musc.edu.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: josep@musc.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prisciandaro', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: priscian@musc.edu.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Killeen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: killeent@musc.edu.'}, {'ForeName': 'Delisa G', 'Initials': 'DG', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: browdg@musc.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Taimina', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: taimina@musc.edu.'}, {'ForeName': 'Ebele', 'Initials': 'E', 'LastName': 'Compean', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Malcolm', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: malcolmr@musc.edu.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Kalivas', 'Affiliation': 'Department of Neuroscience, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kalivasp@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105961']
568,32108442,Effect of Plain Versus Sugar-Sweetened Breakfast on Energy Balance and Metabolic Health: A Randomized Crossover Trial.,"OBJECTIVE


This study investigated the effect of 3 weeks of high-sugar (""Sweet"") versus low-sugar (""Plain"") breakfast on energy balance, metabolic health, and appetite.
METHODS


A total of 29 healthy adults (22 women) completed this randomized crossover study. Participants had pre- and postintervention appetite, health, and body mass outcomes measured, and they recorded diet, appetite (visual analogue scales), and physical activity for 8 days during each intervention. Interventions were 3 weeks of isoenergetic Sweet (30% by weight added sugar; average 32 g of sugar) versus Plain (no added sugar; average 8 g of sugar) porridge-based breakfasts.
RESULTS


Pre- to postintervention changes in body mass were similar between Plain (Δ 0.1 kg; 95% CI: -0.3 to 0.5 kg) and Sweet (Δ 0.2 kg; 95% CI: -0.2 to 0.5 kg), as were pre- to postintervention changes for biomarkers of health (all P ≥ 0.101) and psychological appetite (all P ≥ 0.152). Energy, fat, and protein intake was not statistically different between conditions. Total carbohydrate intake was higher during Sweet (287 ± 82 g/d vs. 256 ± 73 g/d; P = 0.009), driven more by higher sugar intake at breakfast (116 ± 46 g/d vs. 88 ± 38 g/d; P < 0.001) than post-breakfast sugar intake (Sweet 84 ± 42 g/d vs. Plain 80 ± 37 g/d; P = 0.552). Participants reported reduced sweet desire immediately after Sweet but not Plain breakfasts (trial × time P < 0.001).
CONCLUSIONS


Energy balance, health markers, and appetite did not respond differently to 3 weeks of high- or low-sugar breakfasts.",2020,"Participants reported reduced sweet desire immediately after Sweet but not Plain breakfasts (trial × time P < 0.001).
",['29 healthy adults (22 women'],"['Plain Versus Sugar-Sweetened Breakfast', 'isoenergetic Sweet (30% by weight added sugar', 'high-sugar (""Sweet"") versus low-sugar (""Plain"") breakfast', 'Plain (no added sugar; average 8 g of\xa0sugar) porridge-based breakfasts']","['body mass', 'reduced sweet desire', 'psychological appetite', 'Energy Balance and Metabolic Health', 'Energy, fat, and protein intake', 'diet, appetite (visual analogue scales), and physical activity', 'energy balance, metabolic health, and appetite', 'Total carbohydrate intake']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0452575', 'cui_str': 'Porridge (substance)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]",29.0,0.323909,"Participants reported reduced sweet desire immediately after Sweet but not Plain breakfasts (trial × time P < 0.001).
","[{'ForeName': 'Harriet A', 'Initials': 'HA', 'LastName': 'Carroll', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Iain S', 'Initials': 'IS', 'LastName': 'Templeman', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Wharton', 'Affiliation': 'Department of Life Sciences, University of Roehampton, London, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Reeves', 'Affiliation': 'Department of Life Sciences, University of Roehampton, London, UK.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Trim', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Enhad A', 'Initials': 'EA', 'LastName': 'Chowdhury', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Brunstrom', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'School for Policy Studies, University of Bristol, Bristol, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22757']
569,32293706,Exploring occupancy of the histamine H 3  receptor by pitolisant in humans using PET.,"BACKGROUND AND PURPOSE


BF2.649 (pitolisant, Wakix®) is a novel histamine H 3  receptor inverse agonist/antagonist recently approved for the treatment of narcolepsy disorder. The objective of the study was to investigate in vivo occupancy of H 3  receptors by BF2.649 using PET brain imaging with the H 3  receptor antagonist radioligand [ 11  C]GSK189254.
EXPERIMENTAL APPROACH


Six healthy adult participants were scanned with [ 11  C]GSK189254. Participants underwent a total of two PET scans on separate days, 3 h after oral administration of placebo or after pitolisant hydrochloride (40 mg). [ 11  C]GSK189254 regional total distribution volumes were estimated in nine brain regions of interest with the two tissue-compartment model with arterial input function using a common V ND  across the regions. Brain receptor occupancies were calculated with the Lassen plot.
KEY RESULTS


Pitolisant, at the dose administered, provided high (84 ± 7%; mean ± SD) occupancy of H 3  receptors. The drug was well-tolerated, and participants experienced few adverse events.
CONCLUSION AND IMPLICATIONS


The administration of pitolisant (40 mg) produces a high occupancy of H 3  receptors and may be a new tool for the treatment of a variety of CNS disorders that are associated with mechanisms involving H 3  receptors.",2020,Pitolisant 40 mg promoted 84±7% (x̅±SD) occupancy of H3R.,"['Humans Using Positron Emission Tomography', 'Six healthy adult participants']",['placebo or after pitolisant hydrochloride'],"['vivo H3R occupancy', 'Brain receptor occupancies']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3529928', 'cui_str': 'pitolisant'}]","[{'cui': 'C0062739', 'cui_str': 'Histamine H3 Receptor'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]",6.0,0.0585618,Pitolisant 40 mg promoted 84±7% (x̅±SD) occupancy of H3R.,"[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rusjan', 'Affiliation': 'Research Imaging Centre, CAMH, Toronto, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Sabioni', 'Affiliation': 'Translational Addiction Research Laboratory, CAMH, Toronto, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Di Ciano', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Esmaeil', 'Initials': 'E', 'LastName': 'Mansouri', 'Affiliation': 'Research Imaging Centre, CAMH, Toronto, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boileau', 'Affiliation': 'Research Imaging Centre, CAMH, Toronto, Canada.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Laveillé', 'Affiliation': 'Bioprojet Pharma, Paris, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Capet', 'Affiliation': 'Bioprojet Pharma, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Duvauchelle', 'Affiliation': 'Bioprojet Pharma, Paris, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Schwartz', 'Affiliation': 'Bioprojet Biotech, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Robert', 'Affiliation': 'Bioprojet Biotech, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': 'Research Imaging Centre, CAMH, Toronto, Canada.'}]",British journal of pharmacology,['10.1111/bph.15067']
570,32290185,Depth of Neuromuscular Block Is Not Associated with Abdominal Wall Distention or Surgical Conditions during Gynecologic Laparoscopic Operations. A Prospective Trial.,"The influence of the degree of a neuromuscular block (NMB) on surgical operating conditions during laparoscopic surgery is debated controversially. The extent of abdominal distension during the time course of the NMB was assessed as a new measurement tool. In 60 patients scheduled for gynecologic laparoscopic surgery, the increase of the abdominal wall length induced by the capnoperitoneum was measured at 5 degrees of the NMB: intense NMB-post-tetanic count (PTC) = 0; deep NMB-train-of-four count (TOF) = 0 and PTC = 1-5; medium NMB-PTC > 5 and TOF = 0-1; shallow NMB-TOF > 1; full recovery-train-of-four ratio TOFR > 90%. Simultaneously, the quality of operating conditions was assessed with a standardized rating scale (SRS) reaching from 1 (extremely poor conditions) to 5 (excellent conditions). Fifty patients could be included in the analysis. The abdominal wall length increased by 10-13 mm induced by the capnoperitoneum. SRS was higher during intense NMB (4.7 ± 0.5) vs. full recovery (4.5 ± 0.5) (mean ± SD;  p  = 0.025). Generally, an intense NMB did not increase abdominal wall length induced by capnoperitoneum. Additionally, its influence on the quality of surgical operating conditions seems to be of minor clinical relevance.",2020,"In 60 patients scheduled for gynecologic laparoscopic surgery, the increase of the abdominal wall length induced by the capnoperitoneum was measured at 5 degrees of the NMB: intense NMB-post-tetanic count (PTC) = 0; deep NMB-train-of-four count (TOF) = 0 and PTC = 1-5; medium NMB-PTC > 5 and TOF = 0-1; shallow NMB-TOF > 1; full recovery-train-of-four ratio TOFR","['Fifty patients could be included in the analysis', '60 patients scheduled for']","['gynecologic laparoscopic surgery', 'neuromuscular block (NMB']","['quality of operating conditions', 'Depth of Neuromuscular Block', 'abdominal distension', 'SRS', 'abdominal wall length', 'standardized rating scale (SRS) reaching']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0836916', 'cui_str': 'Abdominal wall structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]",60.0,0.0653235,"In 60 patients scheduled for gynecologic laparoscopic surgery, the increase of the abdominal wall length induced by the capnoperitoneum was measured at 5 degrees of the NMB: intense NMB-post-tetanic count (PTC) = 0; deep NMB-train-of-four count (TOF) = 0 and PTC = 1-5; medium NMB-PTC > 5 and TOF = 0-1; shallow NMB-TOF > 1; full recovery-train-of-four ratio TOFR","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Soltesz', 'Affiliation': 'Department of Anesthesia and Intensive Care, Rheinland Klinikum Dormagen, 41540 Dormagen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Mathes', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, University Hospital of Cologne, 50924 Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Anapolski', 'Affiliation': 'Department Ob/Gyn, University of Witten-Herdecke, Rheinland Klinikum Dormagen, 41540 Dormagen, Germany.'}, {'ForeName': 'Karl Guenter', 'Initials': 'KG', 'LastName': 'Noé', 'Affiliation': 'Department Ob/Gyn, University of Witten-Herdecke, Rheinland Klinikum Dormagen, 41540 Dormagen, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9041078']
571,32290271,"Effects of Whey Protein Supplementation on Aortic Stiffness, Cerebral Blood Flow, and Cognitive Function in Community-Dwelling Older Adults: Findings from the ANCHORS A-WHEY Clinical Trial.","ANCHORS A-WHEY was a 12-week randomized controlled trial (RCT) designed to examine the effect of whey protein on large artery stiffness, cerebrovascular responses to cognitive activity and cognitive function in older adults.
METHODS


99 older adults (mean ± SD; age 67 ± 6 years, BMI 27.2 ± 4.7kg/m 2 , 45% female) were randomly assigned to 50g/daily of whey protein isolate (WPI) or an iso-caloric carbohydrate (CHO) control for 12 weeks (NCT01956994). Aortic stiffness was determined as carotid-femoral pulse wave velocity (cfPWV). Aortic hemodynamic load was assessed as the product of aortic systolic blood pressure and heart rate (Ao SBP × HR). Cerebrovascular response to cognitive activity was assessed as change in middle-cerebral artery (MCA) blood velocity pulsatility index (PI) during a cognitive perturbation (Stroop task). Cognitive function was assessed using a computerized neurocognitive battery.
RESULTS


cfPWV increased slightly in CHO and significantly decreased in WPI ( p  < 0.05). Ao SBP × HR was unaltered in CHO but decreased significantly in WPI ( p  < 0.05). Although emotion recognition selectively improved with WPI ( p  < 0.05), WPI had no effect on other domains of cognitive function or MCA PI response to cognitive activity ( p  > 0.05 for all).
CONCLUSIONS


Compared to CHO, WPI supplementation results in favorable reductions in aortic stiffness and aortic hemodynamic load with limited effects on cognitive function and cerebrovascular function in community-dwelling older adults.",2020,"Although emotion recognition selectively improved with WPI ( p  < 0.05), WPI had no effect on other domains of cognitive function or MCA PI response to cognitive activity ( p  > 0.05 for all).
","['older adults', 'Community-Dwelling Older Adults', 'community-dwelling older adults', '99 older adults (mean ± SD; age 67 ± 6 years, BMI 27.2 ± 4.7kg/m 2 , 45% female']","['whey protein', 'Whey Protein Supplementation', 'CHO, WPI supplementation', 'whey protein isolate (WPI) or an iso-caloric carbohydrate (CHO) control']","['Aortic hemodynamic load', 'carotid-femoral pulse wave velocity (cfPWV', 'cfPWV increased slightly in CHO', 'middle-cerebral artery (MCA) blood velocity pulsatility index (PI) during a cognitive perturbation (Stroop task', 'cognitive function or MCA PI response to cognitive activity', 'Ao SBP × HR', 'Aortic stiffness', 'large artery stiffness, cerebrovascular responses to cognitive activity and cognitive function', 'aortic systolic blood pressure and heart rate (Ao SBP × HR', 'Cerebrovascular response to cognitive activity', 'WPI', 'CHO', 'cognitive function and cerebrovascular function', 'Cognitive function', 'Aortic Stiffness, Cerebral Blood Flow, and Cognitive Function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C5191357', 'cui_str': '27.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0226003', 'cui_str': 'Structure of large artery'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}]",99.0,0.0226556,"Although emotion recognition selectively improved with WPI ( p  < 0.05), WPI had no effect on other domains of cognitive function or MCA PI response to cognitive activity ( p  > 0.05 for all).
","[{'ForeName': 'Wesley K', 'Initials': 'WK', 'LastName': 'Lefferts', 'Affiliation': 'Human Performance Laboratory, Department of Exercise Science, Syracuse University, Syracuse, NY 13244, USA.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Augustine', 'Affiliation': 'Human Performance Laboratory, Department of Exercise Science, Syracuse University, Syracuse, NY 13244, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Spartano', 'Affiliation': 'Human Performance Laboratory, Department of Exercise Science, Syracuse University, Syracuse, NY 13244, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Hughes', 'Affiliation': 'Human Performance Laboratory, Department of Exercise Science, Syracuse University, Syracuse, NY 13244, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Human Performance Laboratory, Department of Exercise Science, Syracuse University, Syracuse, NY 13244, USA.'}, {'ForeName': 'Brigid K', 'Initials': 'BK', 'LastName': 'Heenan', 'Affiliation': 'Human Performance Laboratory, Department of Exercise Science, Syracuse University, Syracuse, NY 13244, USA.'}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'Heffernan', 'Affiliation': 'Human Performance Laboratory, Department of Exercise Science, Syracuse University, Syracuse, NY 13244, USA.'}]",Nutrients,['10.3390/nu12041054']
572,32291277,Effects of Novel Dual GIP and GLP-1 Receptor Agonist Tirzepatide on Biomarkers of Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes.,"OBJECTIVE


To determine the effect of tirzepatide, a dual agonist of glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1 receptors, on biomarkers of nonalcoholic steatohepatitis (NASH) and fibrosis in patients with type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS


Patients with T2DM received either once weekly tirzepatide (1, 5, 10, or 15 mg), dulaglutide (1.5 mg), or placebo for 26 weeks. Changes from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST), keratin-18 (K-18), procollagen III (Pro-C3), and adiponectin were analyzed in a modified intention-to-treat population.
RESULTS


Significant ( P  < 0.05) reductions from baseline in ALT (all groups), AST (all groups except tirzepatide 10 mg), K-18 (tirzepatide 5, 10, 15 mg), and Pro-C3 (tirzepatide 15 mg) were observed at 26 weeks. Decreases with tirzepatide were significant compared with placebo for K-18 (10 mg) and Pro-C3 (15 mg) and with dulaglutide for ALT (10, 15 mg). Adiponectin significantly increased from baseline with tirzepatide compared with placebo (10, 15 mg).
CONCLUSIONS


In post hoc analyses, higher tirzepatide doses significantly decreased NASH-related biomarkers and increased adiponectin in patients with T2DM.",2020,"RESULTS


Significant ( P  < 0.05) reductions from baseline in ALT (all groups), AST (all groups except tirzepatide 10 mg), K-18 (tirzepatide 5, 10, 15 mg), and Pro-C3 (tirzepatide 15 mg) were observed at 26 weeks.","['patients with T2DM', 'Patients With Type 2 Diabetes', 'patients with type 2 diabetes mellitus (T2DM', 'Patients with T2DM received either once weekly']","['tirzepatide', 'placebo', 'dulaglutide', 'Novel Dual GIP and GLP-1 Receptor Agonist Tirzepatide', 'AST']","['NASH-related biomarkers and increased adiponectin', 'alanine aminotransferase (ALT), aspartate aminotransferase (AST), keratin-18 (K-18), procollagen III (Pro-C3), and adiponectin', 'Adiponectin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}]","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0010805', 'cui_str': 'Cytokeratin 18'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0071997', 'cui_str': 'Pro-Complement 3'}]",,0.0602816,"RESULTS


Significant ( P  < 0.05) reductions from baseline in ALT (all groups), AST (all groups except tirzepatide 10 mg), K-18 (tirzepatide 5, 10, 15 mg), and Pro-C3 (tirzepatide 15 mg) were observed at 26 weeks.","[{'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hartman', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN hartman_mark_l@lilly.com.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, Department of Medicine, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Wilson', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Nikooienejad', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Bray', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Chrisanthi A', 'Initials': 'CA', 'LastName': 'Karanikas', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Duffin', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Robins', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haupt', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}]",Diabetes care,['10.2337/dc19-1892']
573,29660858,Peer counselling improves breastfeeding practices: A cluster randomized controlled trial in urban Bangladesh.,"This study aimed to evaluate the impact of peer counselling on early initiation of breastfeeding (EIBF) and exclusive breastfeeding (EBF) rates for mother-infant pairs living in urban slums, Dhaka, Bangladesh. This randomized controlled trial enrolled 350 mother-infant pairs from selected slums between September 2014 and July 2016. The women assigned to intervention group received peer counselling from locally recruited, trained community female volunteers starting in third trimester of pregnancy until 6 months after delivery; control group received no intervention. EIBF, any liquids given after birth, and EBF were compared between groups. Follow-up was scheduled at enrolment, following childbirth, and every 2 months up to 6 months after delivery. Multiple logistic regressions were used to assess the effect peer counselling and other associated factors on EIBF and EBF practices. EIBF rate was higher in the intervention group than in the control group (89.1% vs. 77.4%, p = .005). More mothers in intervention group were exclusively breastfeeding at 5 months than mothers in the control group (73% vs. 27%, p < .005). Control mothers were twice as likely to not practice EIBF compared with intervention mothers (adjusted odds risk [aOR]: 2.53, CI [1.29, 4.97], p = .007). Overall, caesarean section was associated with an 8.9-fold higher risk of not achieving EIBF (aOR: 8.90, CI [4.05, 19.55], p < .001). Intervention mothers were 5.10-fold more likely to practice EBF compared with control mothers (aOR: 5.10, CI [2.89, 9.01], p < .001) at 5 months. This study demonstrates peer counselling can positively influence both EIBF and EBF among mothers living in urban area.",2018,"EIBF rate was higher in the intervention group than in the control group (89.1% vs. 77.4%, p = .005).","['350 mother-infant pairs from selected slums between September 2014 and July 2016', 'mothers living in urban area', 'mother-infant pairs living in urban slums, Dhaka, Bangladesh', 'urban Bangladesh']","['peer counselling from locally recruited, trained community female volunteers starting in third trimester of pregnancy until 6\xa0months after delivery; control group received no intervention', 'Peer counselling', 'peer counselling']","['EIBF rate', 'Overall, caesarean section', 'breastfeeding practices', 'practice EBF', 'early initiation of breastfeeding (EIBF) and exclusive breastfeeding (EBF) rates']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2317036', 'cui_str': 'Initiation of breastfeeding'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}]",350.0,0.131108,"EIBF rate was higher in the intervention group than in the control group (89.1% vs. 77.4%, p = .005).","[{'ForeName': 'Gulshan', 'Initials': 'G', 'LastName': 'Ara', 'Affiliation': 'ICDDR, B, Dhaka, Bangladesh.'}, {'ForeName': 'Mansura', 'Initials': 'M', 'LastName': 'Khanam', 'Affiliation': 'ICDDR, B, Dhaka, Bangladesh.'}, {'ForeName': 'Nowshin', 'Initials': 'N', 'LastName': 'Papri', 'Affiliation': 'ICDDR, B, Dhaka, Bangladesh.'}, {'ForeName': 'Baitun', 'Initials': 'B', 'LastName': 'Nahar', 'Affiliation': 'ICDDR, B, Dhaka, Bangladesh.'}, {'ForeName': 'Md Ahshanul', 'Initials': 'MA', 'LastName': 'Haque', 'Affiliation': 'ICDDR, B, Dhaka, Bangladesh.'}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Kabir', 'Affiliation': 'Bangladesh Breastfeeding Foundation (BBF), Dhaka, Bangladesh.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dibley', 'Affiliation': 'Sydney School of Public Health, Edward Ford Building (A27), University of Sydney, Sydney, New South Wales, Australia.'}]",Maternal & child nutrition,['10.1111/mcn.12605']
574,32290078,Transcranial Direct Current Stimulation of the Occipital Cortex in Medication Overuse Headache: A Pilot Randomized Controlled Cross-Over Study.,"BACKGROUND


Medication overuse headache (MOH) is a chronic pain syndrome that arises from the frequent use of acute antimigraine drugs. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique with a possible therapeutic effect in this particular context.
METHODS


This was a randomized, sham-controlled, cross-over study. Eighteen patients with MOH (17 women, age range: 20-38 years) received three sets of three consecutive daily sessions of tDCS: anodal tDCS over the prefrontal cortex, cathodal tDCS over the occipital cortex ipsilateral to the dominant side of migraine pain, and sham. The order in which the tDCS blocks were delivered was randomly defined based on a 1:1:1 ratio. Patients filled in a migraine diary that allowed recording of the pain intensity (visual analogue scale) and the daily consumption of analgesic pills from one week before to two weeks after each condition.
RESULTS


Both prefrontal and occipital tDCS lowered the total number of migraine days and the number of severe migraine days per week at week 1, but only the effects of occipital tDCS on these two outcomes lasted until week 2. Only occipital tDCS decreased the daily analgesic pills consumption, at weeks 1 and 2.
CONCLUSION


Three consecutive days of cathodal occipital tDCS appear to improve the clinical outcomes in patients with MOH.",2020,"Both prefrontal and occipital tDCS lowered the total number of migraine days and the number of severe migraine days per week at week 1, but only the effects of occipital tDCS on these two outcomes lasted until week 2.","['patients with MOH', 'Eighteen patients with MOH (17 women, age range: 20-38 years', 'Medication Overuse Headache']","['Transcranial Direct Current Stimulation of the Occipital Cortex', 'tDCS: anodal tDCS', 'Transcranial direct current stimulation (tDCS', 'cathodal tDCS']","['clinical outcomes', 'daily analgesic pills consumption', 'total number of migraine days and the number of severe migraine', 'pain intensity (visual analogue scale) and the daily consumption of analgesic pills']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522254', 'cui_str': 'Analgesic overuse headache'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0028785', 'cui_str': 'Occipital lobe structure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",18.0,0.0362114,"Both prefrontal and occipital tDCS lowered the total number of migraine days and the number of severe migraine days per week at week 1, but only the effects of occipital tDCS on these two outcomes lasted until week 2.","[{'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Mansour', 'Affiliation': 'Department of Internal Medicine, the Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Rechdi', 'Initials': 'R', 'LastName': 'Ahdab', 'Affiliation': 'Gilbert and Rose Mary Chagoury School of Medicine School of Medicine, Lebanese American University, Byblos 4504, Lebanon.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Khazen', 'Affiliation': 'Gilbert and Rose Mary Chagoury School of Medicine School of Medicine, Lebanese American University, Byblos 4504, Lebanon.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'El-Khoury', 'Affiliation': 'Gilbert and Rose Mary Chagoury School of Medicine School of Medicine, Lebanese American University, Byblos 4504, Lebanon.'}, {'ForeName': 'Toni M', 'Initials': 'TM', 'LastName': 'Sabbouh', 'Affiliation': 'Department of Internal Medicine, Morristown Medical Center, Morristown, NJ 07960, USA.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Salem', 'Affiliation': 'Gilbert and Rose Mary Chagoury School of Medicine School of Medicine, Lebanese American University, Byblos 4504, Lebanon.'}, {'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Yamak', 'Affiliation': 'Gilbert and Rose Mary Chagoury School of Medicine School of Medicine, Lebanese American University, Byblos 4504, Lebanon.'}, {'ForeName': 'Moussa A', 'Initials': 'MA', 'LastName': 'Chalah', 'Affiliation': 'Service de Physiologie-Explorations Fonctionnelles, Hôpital Henri Mondor, Assistance Publique- Hôpitaux de Paris, 94010 Créteil, France.'}, {'ForeName': 'Samar S', 'Initials': 'SS', 'LastName': 'Ayache', 'Affiliation': 'Service de Physiologie-Explorations Fonctionnelles, Hôpital Henri Mondor, Assistance Publique- Hôpitaux de Paris, 94010 Créteil, France.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Riachi', 'Affiliation': 'Gilbert and Rose Mary Chagoury School of Medicine School of Medicine, Lebanese American University, Byblos 4504, Lebanon.'}]",Journal of clinical medicine,['10.3390/jcm9041075']
575,32290122,Consuming  Gymnema sylvestre  Reduces the Desire for High-Sugar Sweet Foods.,"Background . Gymnemic acids, from the plant  Gymnema sylvestre  (GS), selectively suppress taste responses to sweet compounds without affecting the perception of other taste elements. The aim of this study was to investigate the effect of consuming a GS-containing mint on the desire to consume high-sugar sweet foods directly thereafter.  Methods . This study utilized a single-blind, crossover design comparing the consumption of a mint (dissolving tablet) containing 4 mg of gymnemic acids with an isocaloric placebo in 56 healthy young men and women. Participants were given samples of their favourite chocolate (varied between 14-18 g; energy varied between 292-370 kJ) and were directed to rate on their hunger on 100-mm visual analogue scales 30 s prior to consuming high-sugar sweet food (chocolate). They then consumed the GS mint or placebo mint and rated their perceived pleasantness and desire for more chocolate on separate visual analogue scales immediately following consumption of the high-sugar sweet food before being offered up to five additional servings (and asked to rate hunger, pleasantness and desire to eat more chocolate between each ingestion period).  Results . The number of chocolate bars eaten decreased by 0.48 bars (21.3%) within a 15-min period of consumption of the GS mint ( p  = 0.006). Desire to eat more of the high-sugar sweet food ( p  = 0.011) and pleasantness of the high-sugar sweet food ( p  < 0.001) was reduced after GS mint intake. Those who reported having a 'sweet tooth' had a greater reduction in the pleasantness of chocolate ( p  = 0.037) and desire to eat more ( p  = 0.004) after consuming the GS mint for the first serving of a high-sugar sweet food following the mint.  Conclusion . Consuming gymnema-containing mints compared to placebo significantly reduced the quantity of chocolate eaten mainly due to a decrease in the desire and pleasantness of consuming it.",2020,Desire to eat more of the high-sugar sweet food ( p  = 0.011) and pleasantness of the high-sugar sweet food ( p  < 0.001) was reduced after GS mint intake.,"['Participants were given samples of their favourite chocolate (varied between 14-18 g; energy varied between 292-370 kJ', '56 healthy young men and women']","['GS-containing mint', 'consumption of a mint (dissolving tablet) containing 4 mg of gymnemic acids with an isocaloric placebo', 'placebo', 'GS mint or placebo']","['pleasantness of chocolate', 'quantity of chocolate eaten', 'desire and pleasantness of consuming it', 'number of chocolate bars eaten']","[{'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0456637', 'cui_str': '18G'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0452249', 'cui_str': 'Mint'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1549535', 'cui_str': 'Dissolve'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0062022', 'cui_str': 'gymnemic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}]",56.0,0.134382,Desire to eat more of the high-sugar sweet food ( p  = 0.011) and pleasantness of the high-sugar sweet food ( p  < 0.001) was reduced after GS mint intake.,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': 'School of Sport, Nutrition and Exercise, Massey University, Auckland 0745, New Zealand.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Diako', 'Affiliation': 'School of Food and Advanced Technology, Massey University, Auckland 0745, New Zealand.'}, {'ForeName': 'Rozanne', 'Initials': 'R', 'LastName': 'Kruger', 'Affiliation': 'School of Sport, Nutrition and Exercise, Massey University, Auckland 0745, New Zealand.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'School of Food and Advanced Technology, Massey University, Auckland 0745, New Zealand.'}, {'ForeName': 'Warrick', 'Initials': 'W', 'LastName': 'Wood', 'Affiliation': 'School of Sport, Nutrition and Exercise, Massey University, Auckland 0745, New Zealand.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Rutherfurd-Markwick', 'Affiliation': 'School of Health Sciences, Massey University, Auckland 0745, New Zealand.'}, {'ForeName': 'Ajmol', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'School of Sport, Nutrition and Exercise, Massey University, Auckland 0745, New Zealand.'}]",Nutrients,['10.3390/nu12041046']
576,32102728,The Effectiveness of Actively Induced Medical Rehabilitation in Chronic Inflammatory Bowel Disease.,"BACKGROUND


The poor evidence base is a major problem for the German rehabilitation sector. This trial focused on testing the efficacy and benefit of inpatient medical rehabilitation compared to routine care in a single common entity, namely, chronic inflammatory bowel disease (IBD).
METHODS


This pragmatic, multicenter, randomized controlled trial with a parallel group design included gainfully employed patients with IBD who were covered by one of four statutory health insurance providers. Patients in the intervention group were actively advised regarding options for rehabilitation and given support in applying for it; patients in the control group continued with the care they had been receiving before participation in the trial. The primary endpoint was social participation, and there were various secondary endpoints, including disease activity and sick days taken off from work. All parameters were assessed by questionnaire at the beginning of the trial and twelve months later. This was trial no. DRKS00009912 in the German clinical trials registry.
RESULTS


In a complete case analysis, the intervention group (211 patients, of whom 112 underwent rehabilitation) did better than the control group (220 patients, of whom 15 underwent rehabilitation) in multiple respects. The reported limitation in social participation was reduced by 7.3 points in the intervention group and 2.9 points in the control group (p = 0.018; d = 0.23). Significant improvements were also seen in disease activity, vitality, health-related quality of life, and self-management, with effect sizes between 0.3 and 0.4. No benefit was seen in outcomes related to working capacity. Sensitivity analyses lent further support to the findings.
CONCLUSION


Rehabilitation research can be conducted with individually randomized, controlled trials. The findings of this trial indicate the absolute effectiveness of ied rehabilitation for IBD patients, as well as its additional benefit compared to routine care.",2020,"Significant improvements were also seen in disease activity, vitality, health-related quality of life, and self-management, with effect sizes between 0.3 and 0.4.","['Chronic Inflammatory Bowel Disease', 'gainfully employed patients with IBD who were covered by one of four statutory health insurance providers']","['inpatient medical rehabilitation', 'Actively Induced Medical Rehabilitation']","['disease activity and sick days taken off from work', 'disease activity, vitality, health-related quality of life, and self-management, with effect sizes', 'social participation']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}]","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0242806', 'cui_str': 'Sick Days'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}]",,0.0879992,"Significant improvements were also seen in disease activity, vitality, health-related quality of life, and self-management, with effect sizes between 0.3 and 0.4.","[{'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hüppe', 'Affiliation': 'Institute of Social Medicine and Epidemiology, University of Lübeck; Center for Population Medicine and Health Services Research, University of Lübeck.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Langbrandtner', 'Affiliation': ''}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Lill', 'Affiliation': ''}, {'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Raspe', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0089']
577,32115652,The altered early components and the decisive later process underlying attention bias modification in social anxiety: evidence from event-related potentials.,"Attention bias modification (ABM) is a potential intervention in relieving social anxiety symptoms, while its underlying neural mechanisms are not yet understood. The current study included 63 college students with social anxiety. Participants were assigned to the attention modification program (AMP, n = 20), the attention control condition (ACC, n = 20) and the passive waiting group (PW, n = 23). Questionnaires and the emotional Stroop task with EEG recordings were used to assess whether and how the 4-week ABM period affected emotional symptoms and specific emotional processing. Results showed that the two training groups (AMP and ACC) produced comparable emotional improvements and both showed a decrease in negative bias compared with the PW group. The ERP results indicated that despite no significant ERP changes in the PW group, the ACC group exhibited a greater N1, whereas the AMP group exhibited a reduced VPP at the post-test stage compared to the pre-test stage. Besides, both training groups showed a similar late positive potential (LPP) reduction. Notably, the reduction in LPP was positively correlated with behavioral and symptom improvement. Thus, manipulations unique to ABM (face-target contingency) primarily modulate the early attention distribution of material-related stimuli. However, the clinical benefits of attention training may be due to later cognitive-affective mechanisms.",2019,Results showed that the two training groups (AMP and ACC) produced comparable emotional improvements and both showed a decrease in negative bias compared with the PW group.,['63 college students with social anxiety'],"['Attention bias modification (ABM', 'attention modification program (AMP, n\u2009=\u200920), the attention control condition (ACC, n\u2009=\u200920) and the passive waiting group']","['VPP', 'late positive potential (LPP) reduction', 'negative bias', 'ERP changes', 'LPP', 'emotional symptoms and specific emotional processing']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0337380', 'cui_str': 'Endoscopic retrograde pancreatography (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",63.0,0.0147367,Results showed that the two training groups (AMP and ACC) produced comparable emotional improvements and both showed a decrease in negative bias compared with the PW group.,"[{'ForeName': 'Dong-Ni', 'Initials': 'DN', 'LastName': 'Pan', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing 100101, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing 100101, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Lei', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing 100101, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing 100101, China.'}, {'ForeName': 'Xuebing', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing 100101, China.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsz098']
578,32290335,Outcomes of Radiotherapy for Mesenchymal and Non-Mesenchymal Subtypes of Gastric Cancer.,"Background:  The purpose of this study was to evaluate the clinical outcomes following postoperative chemotherapy (XP) versus chemoradiotherapy (XP-RT) according to mesenchymal subtype based on RNA sequencing in gastric cancer (GC) in a cohort of the Adjuvant chemoRadioTherapy In Stomach Tumor (ARTIST) trial.  Methods:  Of the 458 patients enrolled in the ARTIST trial, formalin-fixed, paraffin-embedded (FFPE) specimens were available from 106 (23.1%) patients for RNA analysis. The mesenchymal subtype was classified according to a previously reported 71-gene MSS/EMT signature using the NanoString assay.  Results:  Of the 106 patients analyzed (50 in XP arm, 56 in XP-RT arm), 36 (34.0%) patients were categorized as mesenchymal subtype by NanoString assay. Recurrence-free survival (RFS,  p  = 0.009, hazard ratio (HR) = 2.11, 95% confidence interval (CI): 1.21-3.70) and overall survival (OS,  p  = 0.003, HR = 2.28, 95% CI: 1.31-3.96) were significantly lower in the mesenchymal subtype than in the non-mesenchymal subtype. In terms of post-operative radiotherapy (RT), mesenchymal subtype was not an independent variable to predict RFS or OS regardless to the assigned arm (XP with or without RT) in this patient cohort. However, there was a trend in the adjuvant XP arm, which showed higher OS than the XP-RT arm for the mesenchymal subtype and lower OS than the XP-RT arm for the non-mesenchymal subtype.  Conclusions:  We could not determine any significant differences between the mesenchymal and non-mesenchymal subtypes with respect to the effects of adjuvant XP with or without RT in gastric cancer following curative surgery.",2020,We could not determine any significant differences between the mesenchymal and non-mesenchymal subtypes with respect to the effects of adjuvant XP with or without RT in gastric cancer following curative surgery.,"['458 patients enrolled in the ARTIST trial, formalin-fixed, paraffin-embedded (FFPE) specimens were available from 106 (23.1%) patients for RNA analysis', 'Gastric Cancer', '106 patients analyzed (50 in XP arm, 56 in XP-RT arm), 36 (34.0%) patients were categorized as mesenchymal subtype by NanoString assay']","['postoperative chemotherapy (XP) versus chemoradiotherapy (XP-RT', 'Radiotherapy', 'Adjuvant chemoRadioTherapy', 'post-operative radiotherapy (RT']","['overall survival', 'Recurrence-free survival (RFS']","[{'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0402043', 'cui_str': 'Artist'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0030415', 'cui_str': 'Paraffin'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]","[{'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3178761', 'cui_str': 'Adjuvant Chemoradiotherapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}]",458.0,0.0693107,We could not determine any significant differences between the mesenchymal and non-mesenchymal subtypes with respect to the effects of adjuvant XP with or without RT in gastric cancer following curative surgery.,"[{'ForeName': 'Jeong Il', 'Initials': 'JI', 'LastName': 'Yu', 'Affiliation': 'Departments of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea.'}, {'ForeName': 'Hee Chul', 'Initials': 'HC', 'LastName': 'Park', 'Affiliation': 'Departments of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea.'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Departments of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Changhoon', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Departments of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Kang', 'Affiliation': 'Departments of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Departments of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Seung Tae', 'Initials': 'ST', 'LastName': 'Kim', 'Affiliation': 'Departments of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Tae Sung', 'Initials': 'TS', 'LastName': 'Sohn', 'Affiliation': 'Departments of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Departments of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Ji Yeong', 'Initials': 'JY', 'LastName': 'An', 'Affiliation': 'Departments of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Min Gew', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Departments of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Jae Moon', 'Initials': 'JM', 'LastName': 'Bae', 'Affiliation': 'Departments of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Kyoung-Mee', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul 03181, Korea.'}, {'ForeName': 'Heewon', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon 06351, Korea.'}, {'ForeName': 'Kyunga', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon 06351, Korea.'}, {'ForeName': 'Sung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Medical Device Management and Research, Samsung Advanced Institute for Health Sciences and Technology, Sungkyunkwan University, Seoul 06351, Korea.'}, {'ForeName': 'Do Hoon', 'Initials': 'DH', 'LastName': 'Lim', 'Affiliation': 'Departments of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea.'}]",Cancers,['10.3390/cancers12040943']
579,32290344,Galacto-Oligosaccharide RP-G28 Improves Multiple Clinical Outcomes in Lactose-Intolerant Patients.,"Background and Aims:  Lactose intolerance (LI) is a global problem affecting more than half of the world's population. An ultra-purified, high-concentration galacto-oligosaccharide, RP-G28, is being developed as a treatment for patients with LI. The efficacy and safety of RP-G28 in reducing symptoms of lactose intolerance were assessed in a blinded, randomized, placebo-controlled trial.  Methods:  In this multiclinical site, double-blinded, placebo-controlled trial, 377 patients with LI were randomized to one of two doses of orally administered RP-G28 or placebo for 30 days. A LI test and symptom assessment were performed at baseline and on day 31. The primary endpoint was a ≥4-point reduction or a score of zero on LI composite score on day 31. Voluntary milk and dairy intake and global outcome measures assessed patients' overall treatment satisfaction and quality of life before therapy and 30 days after therapy. This study received Institutional Review Board (IRB) approval.  Results:  For the primary endpoint, 40% in the RP-G28 groups reported a ≥4-point reduction or no symptoms on LI symptom composite score compared to 26% with placebo (P = 0.016). Treatment with RP-G28 also led to significantly higher levels of milk and dairy intake and significant improvements in global assessments compared to placebo. RP-G28 but not placebo led to significant increases in five  Bifidobacterium  taxa.  Conclusions:  RP-G28 for 30 days significantly reduced symptoms and altered the fecal microbiome in patients with LI. Treatment with RP-G28 also improved milk/dairy consumption and quality of life and was safe and well tolerated.",2020,Treatment with RP-G28 also led to significantly higher levels of milk and dairy intake and significant improvements in global assessments compared to placebo.,"['Lactose-Intolerant Patients', '377 patients with LI', 'patients with LI']","['Lactose intolerance (LI', 'placebo', 'RP-G28', 'RP-G28 or placebo', 'Galacto-Oligosaccharide RP-G28']","['global assessments', 'milk/dairy consumption and quality of life and was safe and well tolerated', ""Voluntary milk and dairy intake and global outcome measures assessed patients' overall treatment satisfaction and quality of life"", 'levels of milk and dairy intake', 'fecal microbiome', '≥4-point reduction or no symptoms on LI symptom composite score', '≥4-point reduction or a score of zero on LI composite score']","[{'cui': 'C0860475', 'cui_str': 'Lactose intolerant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022951', 'cui_str': 'Intolerance to lactose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3851806', 'cui_str': 'RP-G28'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0919414', 'cui_str': '0'}]",377.0,0.583276,Treatment with RP-G28 also led to significantly higher levels of milk and dairy intake and significant improvements in global assessments compared to placebo.,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chey', 'Affiliation': 'Gastroenterology and Nutrition Sciences 3912 Taubman Center, SPC 5362, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, San Diego, CA 92093, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Ritter', 'Affiliation': 'Ritter Pharmaceuticals, Inc., Los Angeles, CA 90067, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Foyt', 'Affiliation': 'Ritter Pharmaceuticals, Inc., Los Angeles, CA 90067, USA.'}, {'ForeName': 'M Andrea', 'Initials': 'MA', 'LastName': 'Azcarate-Peril', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology and UNC Microbiome Core, School of Medicine, University of North Carolina at Chapel Hill, NC 27514, USA.'}, {'ForeName': 'Dennis A', 'Initials': 'DA', 'LastName': 'Savaiano', 'Affiliation': 'Meredith Professor of Nutrition Science, Institution: Purdue University, West Lafayette, IN 47907, USA.'}]",Nutrients,['10.3390/nu12041058']
580,32290490,Health-Related Physical Fitness Benefits in Sedentary Women Employees after an Exercise Intervention with Zumba Fitness ® .,"Background : The protective properties of high physical fitness levels on health are manifest independently of age, sex, fatness, smoking, alcohol consumption, and other clinical factors. However, women are less active than men, which contributes to low physical fitness and a high risk of CVD. Thus, the objective of this study is to analyze the effect of two exercise interventions on health-related physical fitness in sedentary employed females.  Methods : A total of 98 physically inactive adult women were randomly assigned to 3 study groups: the control group (CG) = 31, the endurance training group based on Zumba Fitness ®  classes (ET;  n  = 39), and the concurrent training group that had an extra muscle-strengthening workout after the Zumba Fitness ®  class (CnT;  n  = 28). Body composition (BMI, waist circumference), motor fitness (one-leg stand test), musculoskeletal fitness (shoulder-neck mobility, handgrip strength test, jump and reach test, and dynamic sit-up test), and cardiorespiratory fitness (2-km test and estimated VO 2  max) were assessed with the ALPHA-Fit test battery for adults.  Results : Both interventions showed a significant improvement in the majority of health-related fitness and body composition variables/test (waist circumference: ET = -2.275 ± 0.95,  p  = 0.02, CnT = -2.550 ± 1.13,  p =  0.03; one-stand leg test: ET = 13.532 ± 2.65,  p  < 0.001; CnT = 11.656 ± 2.88,  p  < 0.001; shoulder-neck mobility: ET = 1.757 ± 0.44,  p  < 0.001, CnT = 2.123 ± 0.47,  p  < 0.001; handgrip test: 0.274 ± 0.08,  p  < 0.001, CnT = 0.352 ± 0.08,  p  < 0.001; dynamic sit-up: ET = 1.769 ± 0.45,  p  < 0.001, CnT = -1.836 ± 0.49,  p  < 0.001; 2-km test time: -1.280 ± 0.25,  p  < 0.001, CnT = -1.808 ± 0.28,  p  < 0.001; estimated VO 2  max: ET = 1.306 ± 0.13,  p  < 0.001, CnT = 1.191 ± 0.15,  p  < 0.001). There were no significant differences after the intervention between the two exercise intervention groups.  Conclusions : Exercise interventions based on Zumba fitness ®  or Zumba fitness ®  combined with an extra muscle-strengthening workout based on bodyweight training exercises are effective strategies to improve the health-related physical fitness in sedentary women employees.",2020,"Both interventions showed a significant improvement in the majority of health-related fitness and body composition variables/test (waist circumference: ET = -2.275 ± 0.95,  ","['sedentary employed females', '98 physically inactive adult women', 'sedentary women employees', 'Sedentary Women Employees']","['exercise interventions', 'extra muscle-strengthening workout based on bodyweight training exercises', 'control group (CG) = 31, the endurance training group based on Zumba Fitness ®  classes (ET;  n  = 39), and the concurrent training group that had an extra muscle-strengthening workout after the Zumba Fitness ®  class (CnT']","['majority of health-related fitness and body composition variables', 'health-related physical fitness', 'ALPHA-Fit test battery for adults', 'Body composition (BMI, waist circumference), motor fitness (one-leg stand test), musculoskeletal fitness (shoulder-neck mobility, handgrip strength test, jump and reach test, and dynamic sit-up test), and cardiorespiratory fitness (2-km test and estimated VO 2  max']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560837', 'cui_str': 'Does sit up'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",98.0,0.0334706,"Both interventions showed a significant improvement in the majority of health-related fitness and body composition variables/test (waist circumference: ET = -2.275 ± 0.95,  ","[{'ForeName': 'Yaira', 'Initials': 'Y', 'LastName': 'Barranco-Ruiz', 'Affiliation': 'Department of Physical and Sports Education, PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, Melilla 52071, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Villa-González', 'Affiliation': 'Department of Physical and Sports Education, PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, Melilla 52071, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17082632']
581,32290521,Leucine-Enriched Essential Amino Acids Improve Recovery from Post-Exercise Muscle Damage Independent of Increases in Integrated Myofibrillar Protein Synthesis in Young Men.,"BACKGROUND


Leucine-enriched essential amino acids (LEAAs) acutely enhance post-exercise myofibrillar protein synthesis (MyoPS), which has been suggested to be important for muscle repair and recovery. However, the ability of LEAAs to concurrently enhance MyoPS and muscle damage recovery in free-living humans has not been studied.
METHODS


In a randomized, double-blind, placebo-controlled, parallel-group design, twenty recreationally active males consuming a controlled diet (1.2 g/kg/d of protein) were supplemented thrice daily with 4 g of LEAAs (containing 1.6 g leucine) or isocaloric placebo for four days following an acute bout of lower-body resistance exercise (RE). MyoPS at rest and integrated over 96 h of recovery was measured by D 2 O. Isometric and isokinetic torque, muscle soreness, Z-band streaming, muscle heat shock protein (HSP) 25 and 72, plasma creatine kinase (CK), and plasma interleukin-6 (IL-6) were measured over 96 h post-RE to assess various direct and indirect markers of muscle damage.
RESULTS


Integrated MyoPS increased ~72% over 96 h after RE ( p  < 0.05), with no differences between groups ( p  = 0.98). Isometric, isokinetic, and total peak torque decreased ~21% by 48 h after RE ( p  < 0.05), whereas total peak torque was ~10% greater overall during recovery in LEAAs compared to placebo ( p  < 0.05). There were moderate to large effects for peak torque in favour of LEAAs. Muscle soreness increased during recovery with no statistical differences between groups but small to moderate effects in favour of LEAAs that correlated with changes in peak torque. Plasma CK, plasma IL-6, and muscle HSP25 increased after RE ( p  < 0.05) but were not significantly different between groups ( p  ≥ 0.13). Consistent with a trend toward attenuated Z-band streaming in LEAAs ( p  = 0.07), muscle HSP72 expression was lower ( p  < 0.05) during recovery in LEAAs compared with placebo. There were no correlations between MyoPS and any measures of muscle damage ( p  ≥ 0.37).
CONCLUSION


Collectively, our data suggest that LEAAs moderately attenuated muscle damage without concomitant increases in integrated MyoPS in the days following an acute bout of resistance exercise in free-living recreationally active men.",2020,Muscle soreness increased during recovery with no statistical differences between groups but small to moderate effects in favour of LEAAs that correlated with changes in peak torque.,"['free-living recreationally active men', 'Young Men', 'twenty recreationally active males consuming a controlled diet (1.2 g/kg/d of protein']","['LEAAs (containing 1.6 g leucine) or isocaloric placebo', 'LEAAs', 'placebo', 'Leucine-Enriched Essential Amino Acids']","['total peak torque', 'peak torque', 'muscle HSP72 expression', 'Muscle soreness', 'Isometric, isokinetic, and total peak torque', 'muscle damage', 'Plasma CK, plasma IL-6, and muscle HSP25', 'D 2 O. Isometric and isokinetic torque, muscle soreness, Z-band streaming, muscle heat shock protein (HSP) 25 and 72, plasma creatine kinase (CK), and plasma interleukin-6 (IL-6']","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C1532536', 'cui_str': 'g/kg/day'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0230719', 'cui_str': 'Z line'}, {'cui': 'C0018850', 'cui_str': 'Heat-Shock Protein'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}]",,0.251633,Muscle soreness increased during recovery with no statistical differences between groups but small to moderate effects in favour of LEAAs that correlated with changes in peak torque.,"[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Waskiw-Ford', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2C9, Canada.'}, {'ForeName': 'Sarkis', 'Initials': 'S', 'LastName': 'Hannaian', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2C9, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Duncan', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2C9, Canada.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': 'Technology Development Center, Institute of Food Sciences and Technologies, Ajinomoto Co., Inc., Kawasaki, Kanagawa 210-8681, Japan.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Abou Sawan', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2C9, Canada.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Locke', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2C9, Canada.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kumbhare', 'Affiliation': 'Toronto Rehabilitation Institute, Toronto, ON M5G 2A2, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Moore', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2C9, Canada.'}]",Nutrients,['10.3390/nu12041061']
582,32290885,Clinical efficacy and safety of switch from bosentan to macitentan in children and young adults with pulmonary arterial hypertension: extended study results.,"BACKGROUND


Macitentan is an orally active, potent, dual endothelin receptor antagonist and is the only registered treatment for pulmonary arterial hypertension that significantly reduced morbidity and mortality in a long-term study.
AIM


We have recently reported that switch from bosentan to macitentan significantly improved exercise capacity in children and young adults with pulmonary arterial hypertension in a 24-week prospective study and well tolerated without adverse events. We now aimed to evaluate clinical efficacy, safety of switch in a larger patient population, in a 24-month prospective study.
METHODS


This is a single-institution, 24-month prospective study. Patients ≥12 years with idiopathic/heritable, pulmonary arterial hypertension, or related to CHD or residual pulmonary arterial hypertension due to repaired congenital systemic-to-pulmonary shunts and on bosentan treatment were included. Concomitant treatment with oral phosphodiesterase type 5 inhibitors/inhaled prostanoids was allowed. Outcome measures included change from baseline to 24 months, in the 6-minute walk distance, functional class, oxygen saturation at rest/after walk distance test, and natriuretic peptide levels. Safety end points included adverse events, laboratory abnormalities.
RESULTS


Twenty-seven patients (19 adults/8 children, mean age: 21.1 ± 6.3 years (12-36), weight: 53.1 ± 15.7 kgs (26-87)) were included. Mean duration of macitentan treatment: 22.3 ± 3.9 months (9-24). Six-minute walk distance significantly improved from baseline (mean: 458 ± 79 m (300-620)) at 6 months (mean: 501 ± 73 m (325-616) + 43 m) (p < 0.05), at 12 months (mean: 514 ± 82 m (330-626) + 56 m) (p < 0.05), and at 24 months (mean: 532 ± 85 m (330-682) + 74 m) (p < 0.05). We observed a significant improvement during the first 6 months but no incremental improvement after 6 months (p > 0.05). Macitentan did not significantly change functional class, oxygen saturation, and natriuretic levels (p > 0.05). None of the patients had anaemia, hepatotoxicity, and peripheral edema.
CONCLUSIONS


Our study is the first study which showed that switch from bosentan to macitentan improved exercise capacity in children and young adults with pulmonary arterial hypertension significantly in the first 6 months and compared to baseline in 24 months and well tolerated without adverse events.",2020,"Macitentan did not significantly change functional class, oxygen saturation, and natriuretic levels (p > 0.05).","['Patients ≥12 years with idiopathic/heritable, pulmonary arterial hypertension, or related to CHD or residual pulmonary arterial hypertension due to repaired congenital systemic-to-pulmonary shunts and on bosentan treatment were included', 'Twenty-seven patients (19 adults/8 children, mean age: 21.1 ± 6.3 years (12-36), weight: 53.1 ± 15.7 kgs (26-87)) were included', 'children and young adults with pulmonary arterial hypertension']",['oral phosphodiesterase type 5 inhibitors/inhaled prostanoids'],"['anaemia, hepatotoxicity, and peripheral edema', 'change functional class, oxygen saturation, and natriuretic levels', 'Clinical efficacy and safety', '6-minute walk distance, functional class, oxygen saturation at rest/after walk distance test, and natriuretic peptide levels', 'Six-minute walk distance', 'pulmonary arterial hypertension', 'adverse events, laboratory abnormalities', 'exercise capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0252643', 'cui_str': 'bosentan'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1318700', 'cui_str': 'Phosphodiesterase 5 inhibitor'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C3160837', 'cui_str': 'Walking distance test'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0500576,"Macitentan did not significantly change functional class, oxygen saturation, and natriuretic levels (p > 0.05).","[{'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Aypar', 'Affiliation': 'Department of Pediatric Cardiology, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Dursun', 'Initials': 'D', 'LastName': 'Alehan', 'Affiliation': 'Department of Pediatric Cardiology, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Tevfik', 'Initials': 'T', 'LastName': 'Karagöz', 'Affiliation': 'Department of Pediatric Cardiology, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Aykan', 'Affiliation': 'Department of Pediatric Cardiology, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'İlker', 'Initials': 'İ', 'LastName': 'Ertugrul', 'Affiliation': 'Department of Pediatric Cardiology, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}]",Cardiology in the young,['10.1017/S1047951120000773']
583,32071118,Results of a Randomized Phase IIb Trial of Nelipepimut-S + Trastuzumab versus Trastuzumab to Prevent Recurrences in Patients with High-Risk HER2 Low-Expressing Breast Cancer.,"PURPOSE


Preclinical data provide evidence for synergism between HER2-targeted peptide vaccines and trastuzumab. The efficacy of this combination was evaluated in patients with HER2 low-expressing breast cancer in the adjuvant setting.
EXPERIMENTAL DESIGN


A phase IIb, multicenter, randomized, single-blinded, controlled trial enrolled disease-free patients after standard therapy completion (NCT01570036). Eligible patients were HLA-A2, A3, A24, and/or A26+, and had HER2 IHC 1+/2+, FISH nonamplified breast cancer, that was node positive and/or hormone receptor negative [triple-negative breast cancer (TNBC)]. Patients received trastuzumab for 1 year and were randomized to placebo (GM-CSF, control) or nelipepimut-S (NPS) with GM-CSF. Primary outcome was 24-month disease-free survival (DFS). Secondary outcomes were 36-month DFS, safety, and immunologic response.
RESULTS


Overall, 275 patients were randomized; 136 received NPS with GM-CSF, and 139 received placebo with GM-CSF. There were no clinicopathologic differences between groups. Concurrent trastuzumab and NPS with GM-CSF was safe with no additional overall or cardiac toxicity compared with control. At median follow-up of 25.7 (interquartile range, 18.4-32.7) months, estimated DFS did not significantly differ between NPS and control [HR, 0.62; 95% confidence interval (CI), 0.31-1.25;  P  = 0.18]. In a planned exploratory analysis of patients with TNBC, DFS was improved for NPS versus control (HR, 0.26; 95% CI, 0.08-0.81,  P  = 0.01).
CONCLUSION


The combination of NPS with trastuzumab is safe. In HER2 low-expressing breast cancer, no significant difference in DFS was seen in the intention-to-treat analysis; however, significant clinical benefit was seen in patients with TNBC. These findings warrant further investigation in a phase III randomized trial.",2020,"In HER2 low-expressing breast cancer, no significant difference in DFS was seen in the intention-to-treat analysis; however, significant clinical benefit was seen in TNBC patients.","['high-risk HER2 low-expressing breast cancer patients', '275 patients were randomized; 136 received', 'HER2 low-expressing breast cancer patients in the adjuvant setting', 'Eligible patients were HLA-A2, A3, A24, and/or A26+, and had HER2 immunohistochemistry 1+/2+, FISH nonamplified breast cancer, that was node positive and/or hormone receptor negative (triple negative breast cancer [TNBC']","['placebo with GM-CSF', 'NPS with trastuzumab', 'NPS with GM-CSF', 'nelipepimut-S + trastuzumab vs trastuzumab', 'placebo (granulocyte-macrophage colony-stimulating factor [GM-CSF], control) or nelipepimut-S (NPS) with GM-CSF', 'trastuzumab', 'Concurrent trastuzumab and NPS with GM-CSF']","['DFS', '24-month disease-free survival (DFS', 'cardiac toxicity', '36-month DFS, safety, and immunologic response', 'estimated DFS']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0019733', 'cui_str': 'HLA-A2'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0876994', 'cui_str': 'Cardiac Toxicity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",275.0,0.140496,"In HER2 low-expressing breast cancer, no significant difference in DFS was seen in the intention-to-treat analysis; however, significant clinical benefit was seen in TNBC patients.","[{'ForeName': 'G Travis', 'Initials': 'GT', 'LastName': 'Clifton', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, Fort Sam Houston, San Antonio, Texas.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Hale', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, Fort Sam Houston, San Antonio, Texas.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Vreeland', 'Affiliation': 'Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Annelies T', 'Initials': 'AT', 'LastName': 'Hickerson', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, Fort Sam Houston, San Antonio, Texas.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Litton', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Gheath', 'Initials': 'G', 'LastName': 'Alatrash', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Rashmi K', 'Initials': 'RK', 'LastName': 'Murthy', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Qiao', 'Affiliation': 'Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Anne V', 'Initials': 'AV', 'LastName': 'Philips', 'Affiliation': 'Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Lukas', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle Cancer Care Alliance, Issaquah, Washington.'}, {'ForeName': 'Jarrod P', 'Initials': 'JP', 'LastName': 'Holmes', 'Affiliation': 'Department of Medical Oncology, St. Joseph Health Cancer Center, Santa Rosa, California.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Peoples', 'Affiliation': 'Department of Surgery, Uniformed Services Health University, Bethesda, Maryland. emittendorf@bwh.harvard.edu gpeoples@cancerinsight.com.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Mittendorf', 'Affiliation': 'Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. emittendorf@bwh.harvard.edu gpeoples@cancerinsight.com.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2741']
584,31634025,Immunogenicity and safety of high-dose quadrivalent influenza vaccine in Japanese adults ≥65 years of age: a randomized controlled clinical trial.,"A trivalent high-dose inactivated influenza vaccine has been licensed in healthy adults ≥65 years of age and provides better protection against influenza infection and related complications than trivalent standard-dose vaccine. This phase I/II clinical trial (NCT03233217), conducted at two sites in Japan, examined the safety and immunogenicity of a quadrivalent formulation of the high-dose inactivated influenza vaccine (IIV4-HD). Healthy adults ≥65 years of age were randomized to receive IIV4-HD by intramuscular injection (n = 60), IIV4-HD by subcutaneous injection (n = 60), or a quadrivalent standard-dose inactivated influenza vaccine (IIV4-SD) by subcutaneous injection (n = 55). Irrespective of administration route, post-vaccination (day 28-35) hemagglutination inhibition geometric mean titers and seroconversion rates were higher for IIV4-HD than for IIV4-SD. Hemagglutination inhibition geometric mean titers and seroconversion rates were also higher for intramuscular than subcutaneous administration of IIV4-HD. Solicited reactions were more common in participants who received IIV4-HD administered subcutaneously than in those who received IIV4-HD administered intramuscularly or IIV4-SD administered subcutaneously. Unsolicited adverse events were similar between the vaccine groups, and no safety signals were detected. This study showed that IIV4-HD administered by either intramuscular or subcutaneous injection was well tolerated and highly immunogenic in healthy Japanese adults ≥65 years of age. Although this study was descriptive, the results add to the evidence that high-dose inactivated influenza vaccines are more immunogenic than standard-dose vaccines in this age group and that intramuscular administration provides greater immunogenicity and lower reactogenicity than subcutaneous administration.",2020,Hemagglutination inhibition geometric mean titers and seroconversion rates were also higher for intramuscular than subcutaneous administration of IIV4-HD.,"['Healthy adults ≥65 years of age', 'healthy Japanese adults ≥65 years of age', 'healthy adults ≥65 years of age', 'Japanese adults ≥65 years of age']","['intramuscular or subcutaneous injection', 'IIV4-HD', 'IIV4-HD administered intramuscularly or IIV4-SD', 'trivalent high-dose inactivated influenza vaccine', 'IIV4-HD by subcutaneous injection (n=60), or a quadrivalent standard-dose inactivated influenza vaccine (IIV4-SD) by subcutaneous injection', 'high-dose quadrivalent influenza vaccine', 'high-dose inactivated influenza vaccine (IIV4-HD', 'IIV4-HD by intramuscular injection']","['Hemagglutination inhibition geometric mean titers and seroconversion rates', 'hemagglutination inhibition geometric mean titers and seroconversion rates', 'tolerated and highly immunogenic', 'Unsolicited adverse events', 'Immunogenicity and safety']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}]","[{'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0612741,Hemagglutination inhibition geometric mean titers and seroconversion rates were also higher for intramuscular than subcutaneous administration of IIV4-HD.,"[{'ForeName': 'Leilani', 'Initials': 'L', 'LastName': 'Sanchez', 'Affiliation': 'Research and Development, Sanofi Pasteur, Taguig, Philippines.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Matsuoka', 'Affiliation': 'Medical Corporation Heishinkai ToCROM Clinic, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': 'Medical Corporation Heishinkai OCROM Clinic, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Sanofi K.K, Tokyo, Japan.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Nakama', 'Affiliation': 'Sanofi K.K, Tokyo, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Sanofi K.K, Tokyo, Japan.'}, {'ForeName': 'Aseem', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Lee-Jah', 'Initials': 'LJ', 'LastName': 'Chang', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1677437']
585,31689166,Hepatitis B and pertussis antibodies in 4- to 5-year-old children previously vaccinated with different hexavalent vaccines.,"In randomized active-comparator controlled studies, DTaP5-HB-IPV-Hib showed comparable immunogenicity and safety to other licensed vaccines. This study assessed persistence of anti-hepatitis B surface antigen (HBs) and anti-pertussis antibodies, when children were 4 to 5 years of age, 3 to 4 years after initial infant/toddler hexavalent vaccination. This was an extension of 2 European studies in which infants/toddlers received either DTaP5-HB-IPV-Hib or DTaP3-HB-IPV/Hib on a 2 + 1 or 3 + 1 schedule. Primary endpoints included percentages with anti-HBs ≥10 mIU/mL, and anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae types 2 & 3 (FIM) greater than or equal to the lower limit of quantitation (LLOQ). One month after 2 + 1 or 3 + 1 dosing, nearly all toddlers had anti-HBs ≥10 mIU/mL, and responded to the received pertussis antigens. Approximately 3 to 4 years later, 65.8%-70.2% in the DTaP5-HB-IPV-Hib and 82.0%-83.7% in the DTaP3-HB-IPV/Hib groups, respectively, had anti-HBs ≥10 mIU/mL. Percentages of children with pertussis antibodies above LLOQ after 2 + 1 dosing were 58.4% and 41.5% (anti-PT), 80.9% and 88.3% (anti-FHA), 66.1% and 72.6% (anti-PRN), and 94.4% and 3.3% (anti-FIM), in the DTaP5-HB-IPV-Hib and DTaP3-HB-IPV/Hib groups, respectively. This study demonstrated, as expected, waning of hepatitis B and pertussis antibodies during the 3 to 4 years after completion of a 3 + 1 or 2 + 1 hexavalent vaccination schedule. Nonetheless, anti-HBs levels ≥10 IU/mL and detectable antibodies against acellular pertussis antigens persisted in most study participants. The implications of these findings for the long-term prevention of hepatitis B and pertussis are further discussed.",2020,"One month after 2 + 1 or 3 + 1 dosing, nearly all toddlers had anti-HBs ≥10 mIU/mL, and responded to the received pertussis antigens.","['children were 4 to 5\xa0years of age, 3 to 4\xa0years after initial infant/toddler hexavalent vaccination']","['anti-hepatitis B surface antigen (HBs) and anti-pertussis antibodies', 'DTaP5-HB-IPV-Hib or DTaP3-HB-IPV/Hib on a 2\xa0+\xa01 or 3\xa0+\xa01 schedule']","['Hepatitis B and pertussis antibodies', 'percentages with anti-HBs ≥10 mIU/mL, and anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae types 2 & 3 (FIM) greater than or equal to the lower limit of quantitation (LLOQ', 'immunogenicity and safety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0369334', 'cui_str': 'Antibody to hepatitis B surface antigen (substance)'}, {'cui': 'C0439457', 'cui_str': 'milliinternational unit/milliliter'}, {'cui': 'C0020731', 'cui_str': 'Histamine-Sensitizing Factor'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0136166', 'cui_str': 'pertactin'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0193221,"One month after 2 + 1 or 3 + 1 dosing, nearly all toddlers had anti-HBs ≥10 mIU/mL, and responded to the received pertussis antigens.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Vesikari', 'Affiliation': 'Department of Pediatrics, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Johnson', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Hall', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Tomáš', 'Initials': 'T', 'LastName': 'Marček', 'Affiliation': 'MCM Vaccine B. V., Leiden, The Netherlands.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Goveia', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Camilo J', 'Initials': 'CJ', 'LastName': 'Acosta', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Andrew Wen-Tseng', 'Initials': 'AW', 'LastName': 'Lee', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1673119']
586,32283820,"Effects of Motor Mental Imagery Training on Tennis Service Performance during the Ramadan Fasting: a Randomized, Controlled Trial.","The objective of the present study is to analyze the effects of motor mental imagery training on tennis service performance among tennis athletes who fast during Ramadan. Participants were 38 young male tennis players, randomly divided into two groups: Imaging Training (IMG,  n  = 18) and control group (CG,  n  = 20). The CG has watched videos on the history of the Olympic Games, while IMG has followed a training program in motor imagery. The performance of the tennis service was obtained by the product between accuracy and speed of typing (accuracy x average speed of all shots (km/h)). The effect of group / time interaction ( p  < 0.01) was identified for all performance indicators (accuracy, running speed and performance (speed x precision)), with improvement only in IMG ( p  = 0.01). The results showed that motor imagery training could be an effective strategy for mitigating/counteracting the negative effects of Ramadan on the tennis service performance.",2020,"The effect of group / time interaction ( p  < 0.01) was identified for all performance indicators (accuracy, running speed and performance (speed x precision)), with improvement only in IMG ( p  = 0.01).","['Participants were 38 young male tennis players', 'tennis athletes who fast during Ramadan', 'Tennis Service Performance during the Ramadan Fasting']","['Imaging Training (IMG,  n  = 18) and control group (CG', 'Motor Mental Imagery Training', 'motor mental imagery training', 'motor imagery training']","['tennis service performance', 'performance indicators (accuracy, running speed and performance (speed x precision']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",38.0,0.0184548,"The effect of group / time interaction ( p  < 0.01) was identified for all performance indicators (accuracy, running speed and performance (speed x precision)), with improvement only in IMG ( p  = 0.01).","[{'ForeName': 'Sofien', 'Initials': 'S', 'LastName': 'Fekih', 'Affiliation': 'Higher Institute of Sport and Physical Education of Gafsa, Gafsa 2100, Tunisia.'}, {'ForeName': 'Mohamed Sami', 'Initials': 'MS', 'LastName': 'Zguira', 'Affiliation': 'Higher Institute of Sport and Physical Education of Gafsa, Gafsa 2100, Tunisia.'}, {'ForeName': 'Abdessalem', 'Initials': 'A', 'LastName': 'Koubaa', 'Affiliation': 'Higher Institute of Sport and Physical Education of Gafsa, Gafsa 2100, Tunisia.'}, {'ForeName': 'Liwa', 'Initials': 'L', 'LastName': 'Masmoudi', 'Affiliation': 'Research Unit: Education, Motricity, Sports and Health, (EM2S, UR15JS01), Higher Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax 3100, Tunisia.'}, {'ForeName': 'Nicola Luigi', 'Initials': 'NL', 'LastName': 'Bragazzi', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), Section of Psychiatry, Genoa University, Genoa 16132, Italy.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Jarraya', 'Affiliation': 'Research Unit: Education, Motricity, Sports and Health, (EM2S, UR15JS01), Higher Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax 3100, Tunisia.'}]",Nutrients,['10.3390/nu12041035']
587,32283681,Role of Parents in Body Mass Reduction in Children with Obesity-Adherence and Success of 1-Year Participation in an Intervention Program.,"Background and Objectives : Obesity in children and adolescents results in a number of serious health-related consequences necessitating early treatment. Support from family members and family-focused lifestyle interventions can improve effectiveness of the treatment. The aim of the study was to assess the effects of parental characteristics and family-based dietary habits on the adherence and success of a body mass reduction program in children with obesity included in a lifestyle intervention program after 1 year.  Materials and Methods : The program included dietetic, psychosocial, and endocrine counseling given to individuals either alone or in groups and was conducted by a multidisciplinary team (consisting of endocrinologists, nurses, psychologists, social counselors, dietitians, and physiotherapists). A total of 113 children aged 10-17 years (mean age 12.9 ± 2.0; 60 girls, 53 boys) were included in the program. After 1 year of participation, the rate of adherence and success were assessed. The effect of the participants' general characteristics, including anthropometric data, as well as parental characteristics (marital status, employment, education, body mass index (BMI), duration of breastfeeding) and the circumstances of meal consumption (eating at home or outside, fast food consumption), was analyzed.  Results : The most important factors predicting body mass reduction success were baseline BMI ( p  < 0.0001) and waist-hip ratio (WHR) ( p  = 0.04), but they did not predict body mass reduction adherence.  Conclusions : The meal consumption habits and support from family members may be among the determinants of adherence to a body mass reduction program for preadolescents and adolescents with obesity. However, the results of the presented study suggested that baseline BMI and WHR are the most important determinants of the body mass reduction success.",2020,"The most important factors predicting body mass reduction success were baseline BMI ( p  < 0.0001) and waist-hip ratio (WHR) ( p  = 0.04), but they did not predict body mass reduction adherence.  ","['children and adolescents', 'children with obesity included in a lifestyle intervention program after 1 year', '113 children aged 10-17 years (mean age 12.9 ± 2.0; 60 girls, 53 boys']","['parental characteristics and family-based dietary habits', 'endocrine counseling given to individuals either alone or in groups and was conducted by a multidisciplinary team', 'Materials and Methods ']","['rate of adherence and success', 'waist-hip ratio (WHR', 'parental characteristics (marital status, employment, education, body mass index (BMI), duration of breastfeeding) and the circumstances of meal consumption (eating at home or outside, fast food consumption']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}]",113.0,0.0423834,"The most important factors predicting body mass reduction success were baseline BMI ( p  < 0.0001) and waist-hip ratio (WHR) ( p  = 0.04), but they did not predict body mass reduction adherence.  ","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Rahelić', 'Affiliation': 'Department of Nutrition and Dietetics, University Hospital Centre Zagreb, 12 Kišpatićeva Str., 10-000 Zagreb, Croatia.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Głąbska', 'Affiliation': 'Chair of Dietetics, Department of Dietetics, Institute of Human Nutrition Sciences, Warsaw University of Life Sciences (WULS-SGGW), 159c Nowoursynowska Str., 02-787 Warsaw, Poland.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Guzek', 'Affiliation': 'Department of Food Market and Consumer Research, Institute of Human Nutrition Sciences, Warsaw University of Life Sciences (WULS-SGGW), 159c Nowoursynowska Str., 02-787 Warsaw, Poland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Pavić', 'Affiliation': 'Department of Nutrition and Dietetics, University Hospital Centre Zagreb, 12 Kišpatićeva Str., 10-000 Zagreb, Croatia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Rumora Samarin', 'Affiliation': 'Faculty of Food Technology and Biotechnology, University of Zagreb, 6 Pierottijeva Str., 10-000 Zagreb, Croatia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Bogdanić', 'Affiliation': 'Department of Pediatrics, University Hospital Centre Zagreb, 12 Kišpatićeva Str., 10-000 Zagreb, Croatia.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Špehar Uroić', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetes, University Hospital Centre Zagreb, 12 Kišpatićeva Str., 10-000 Zagreb, Croatia.'}, {'ForeName': 'Nataša', 'Initials': 'N', 'LastName': 'Rojnić Putarek', 'Affiliation': 'Juraj Dobrila University of Pula, 30 Zagrebačka Str., 52-000 Pula, Croatia.'}, {'ForeName': 'Nevena', 'Initials': 'N', 'LastName': 'Krnić', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetes, University Hospital Centre Zagreb, 12 Kišpatićeva Str., 10-000 Zagreb, Croatia.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56040168']
588,32283762,Dietary Supplementation with Curcumin Reduce Circulating Levels of Glycogen Synthase Kinase-3β and Islet Amyloid Polypeptide in Adults with High Risk of Type 2 Diabetes and Alzheimer's Disease.,"Dietary supplementation with curcumin has been previously reported to have beneficial effects in people with insulin resistance, type 2 diabetes (T2D) and Alzheimer's disease (AD). This study investigated the effects of dietary supplementation with curcumin on key peptides implicated in insulin resistance in individuals with high risk of developing T2D. Plasma samples from participants recruited for a randomised controlled trial with curcumin (180 mg/day) for 12 weeks were analysed for circulating glycogen synthase kinase-3 β (GSK-3β) and islet amyloid polypeptide (IAPP). Outcome measures were determined using ELISA kits. The homeostasis model for assessment of insulin resistance (HOMA-IR) was measured as parameters of glycaemic control. Curcumin supplementation significantly reduced circulating GSK-3β (-2.4 ± 0.4 ng/mL vs. -0.3 ± 0.6,  p  = 0.0068) and IAPP (-2.0 ± 0.7 ng/mL vs. 0.4 ± 0.6,  p  = 0.0163) levels compared with the placebo group. Curcumin supplementation significantly reduced insulin resistance (-0.3 ± 0.1 vs. 0.01 ± 0.05,  p  = 0.0142) compared with placebo group. Dietary supplementation with curcumin reduced circulating levels of IAPP and GSK-3β, thus suggesting a novel mechanism through which curcumin could potentially be used for alleviating insulin resistance related markers for reducing the risk of T2D and AD.",2020,"Curcumin supplementation significantly reduced circulating GSK-3β (-2.4 ± 0.4 ng/mL vs. -0.3 ± 0.6,  p  = 0.0068) and IAPP (-2.0 ± 0.7 ng/mL vs. 0.4 ± 0.6,  p  = 0.0163) levels compared with the placebo group.","['individuals with high risk of developing T2D. Plasma samples from participants recruited', ""Adults with High Risk of Type 2 Diabetes and Alzheimer's Disease"", ""people with insulin resistance, type 2 diabetes (T2D) and Alzheimer's disease (AD""]","['Dietary Supplementation with Curcumin', 'placebo', 'Curcumin supplementation', 'dietary supplementation with curcumin', 'curcumin']","['insulin resistance (HOMA-IR', 'circulating glycogen synthase kinase-3 β (GSK-3β) and islet amyloid polypeptide (IAPP', 'insulin resistance', 'IAPP', 'circulating GSK-3β']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0244989', 'cui_str': 'GSK-3'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}]",,0.193251,"Curcumin supplementation significantly reduced circulating GSK-3β (-2.4 ± 0.4 ng/mL vs. -0.3 ± 0.6,  p  = 0.0068) and IAPP (-2.0 ± 0.7 ng/mL vs. 0.4 ± 0.6,  p  = 0.0163) levels compared with the placebo group.","[{'ForeName': 'Rohith N', 'Initials': 'RN', 'LastName': 'Thota', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Jessica I', 'Initials': 'JI', 'LastName': 'Rosato', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Cintia B', 'Initials': 'CB', 'LastName': 'Dias', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Ralph N', 'Initials': 'RN', 'LastName': 'Martins', 'Affiliation': 'School of Biomedical Sciences, Macquarie University, Macquarie, NSW 2109, Australia.'}, {'ForeName': 'Manohar L', 'Initials': 'ML', 'LastName': 'Garg', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan, NSW 2308, Australia.'}]",Nutrients,['10.3390/nu12041032']
589,31157583,Neoadjuvant Trastuzumab Emtansine and Pertuzumab in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Three-Year Outcomes From the Phase III KRISTINE Study.,"PURPOSE


The KRISTINE study compared neoadjuvant trastuzumab emtansine plus pertuzumab (T-DM1+P) with docetaxel, carboplatin, trastuzumab plus P (TCH+P) for the treatment human epidermal growth factor receptor 2-positive stage II to III breast cancer. T-DM1+P led to a lower pathologic complete response rate (44.4%  v  55.7%;  P  = .016), but fewer grade 3 or greater and serious adverse events (AEs). Here, we present 3-year outcomes from KRISTINE.
METHODS


Patients were randomly assigned to neoadjuvant T-DM1+P or TCH+P every 3 weeks for six cycles. Patients who received T-DM1+P continued adjuvant T-DM1+P, and patients who received TCH+P received adjuvant trastuzumab plus pertuzumab. Secondary end points included event-free survival (EFS), overall survival, patient-reported outcomes (measured from random assignment), and invasive disease-free survival (IDFS; measured from surgery).
RESULTS


Of patients, 444 were randomly assigned (T-DM1+P, n = 223; TCH+P, n = 221). Median follow-up was 37 months. Risk of an EFS event was higher with TDM-1+P (hazard ratio [HR], 2.61 [95% CI, 1.36 to 4.98]) with more locoregional progression events before surgery (15 [6.7%]  v  0). Risk of an IDFS event after surgery was similar between arms (HR, 1.11 [95% CI, 0.52 to 2.40]). Pathologic complete response was associated with a reduced risk of an IDFS event (HR, 0.24 [95% CI, 0.09 to 0.60]) regardless of treatment arm. Overall, grade 3 or greater AEs (31.8%  v  67.7%) were less common with T-DM1+P. During adjuvant treatment, grade 3 or greater AEs (24.5%  v  9.9%) and AEs leading to treatment discontinuation (18.4%  v  3.8%) were more common with T-DM1+P. Patient-reported outcomes favored T-DM1+P during neoadjuvant treatment and were similar to trastuzumab plus pertuzumab during adjuvant treatment.
CONCLUSION


Compared with TCH+P, T-DM1+P resulted in a higher risk of an EFS event owing to locoregional progression events before surgery, a similar risk of an IDFS event, fewer grade 3 or greater AEs during neoadjuvant treatment, and more AEs leading to treatment discontinuation during adjuvant treatment.",2019,"T-DM1+P led to a lower pathologic complete response rate (44.4%  v  55.7%;  P  = .016), but fewer grade 3 or greater and serious adverse events (AEs).","['Patients', 'Of patients', 'Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer']","['TCH+P, T-DM1+P', 'TCH+P received adjuvant trastuzumab plus pertuzumab', 'Neoadjuvant Trastuzumab Emtansine and Pertuzumab', 'neoadjuvant trastuzumab emtansine plus pertuzumab (T-DM1+P) with docetaxel, carboplatin, trastuzumab plus P (TCH+P', 'neoadjuvant T-DM1+P or TCH+P']","['reduced risk of an IDFS event', 'locoregional progression events', 'Overall, grade 3 or greater AEs', 'grade 3 or greater AEs', 'pathologic complete response rate', 'Pathologic complete response', 'event-free survival (EFS), overall survival, patient-reported outcomes (measured from random assignment), and invasive disease-free survival (IDFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0449770', 'cui_str': 'Measured from (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",444.0,0.300328,"T-DM1+P led to a lower pathologic complete response rate (44.4%  v  55.7%;  P  = .016), but fewer grade 3 or greater and serious adverse events (AEs).","[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Universidad Complutense, CUBERONC, GEICAM, Madrid, Spain.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chiun-Sheng', 'Initials': 'CS', 'LastName': 'Huang', 'Affiliation': 'National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Republic of China.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'University of Munich, Munich, Germany.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Valero', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Daniil', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Moscow City Oncology Hospital 62, Moscow, Russia.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wildiers', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': 'Centre René Gauducheau, Saint-Herblain, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Boileau', 'Affiliation': 'McGill University, Jewish General Hospital Segal Cancer Centre, Montréal, Québec, Canada.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Afenjar', 'Affiliation': 'Translational Research in Oncology, Paris, France.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Spera', 'Affiliation': 'Translational Research in Oncology, Montevideo, Uruguay.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Lopez-Valverde', 'Affiliation': 'PAREXEL International GmbH, Berlin, Germany.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Trask', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Boulet', 'Affiliation': 'PAREXEL International GmbH, Berlin, Germany.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'W Fraser', 'Initials': 'WF', 'LastName': 'Symmans', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Thompson', 'Affiliation': 'Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Slamon', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00882']
590,32285318,Random forest for prediction of contrast-induced nephropathy following coronary angiography.,"The majority of prediction models for contrast-induced nephropathy (CIN) have moderate performance. Therefore, we aimed to develop a better pre-procedural prediction tool for CIN following contemporary percutaneous coronary intervention (PCI) or coronary angiography (CAG). A total of 3469 patients undergoing PCI/CAG between January 2010 and December 2013 were randomly divided into a training (n = 2428, 70%) and validation data-sets (n = 1041, 30%). Random forest full models were developed using 40 pre-procedural variables, of which 13 variables were selected for a reduced CIN model. CIN developed in 78 (3.21%) and 37 of patients (3.54%) in the training and validation datasets, respectively. In the validation dataset, the full and reduced models demonstrated improved discrimination over classic Mehran, ACEF CIN risk scores (AUC 0.842 and 0.825 over 0.762 and 0.701, respectively, all P < 0.05) and common estimated glomerular filtration rate. Compared to that for the Mehran risk score model, the full and reduced models had significantly improved fit based on the net reclassification improvement (all P < 0.001) and integrated discrimination improvement (P = 0.001, 0.028, respectively). Using the above models, 2462 (66.7%), 661, and 346 patients were categorized into low (< 1%), moderate (1% to 7%), and high (> 7%) risk groups, respectively. Our pre-procedural CIN risk prediction algorithm (http://cincalc.com) demonstrated good discriminative ability and was well calibrated when validated. Two-thirds of the patients were at low CIN risk, probably needing less peri-procedural preventive strategy; however, the discriminative ability of CIN risk requires further external validation. TRIAL REGISTRATION: ClinicalTrials.gov NCT01400295.",2020,"In the validation dataset, the full and reduced models demonstrated improved discrimination over classic Mehran, ACEF CIN risk scores (AUC 0.842 and 0.825 over 0.762 and 0.701, respectively, all P < 0.05) and common estimated glomerular filtration rate.",['3469 patients undergoing PCI/CAG between January 2010 and December 2013'],['percutaneous coronary intervention (PCI) or coronary angiography (CAG'],"['discrimination over classic Mehran, ACEF CIN risk scores', 'CIN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",3469.0,0.0288732,"In the validation dataset, the full and reduced models demonstrated improved discrimination over classic Mehran, ACEF CIN risk scores (AUC 0.842 and 0.825 over 0.762 and 0.701, respectively, all P < 0.05) and common estimated glomerular filtration rate.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Shiqun', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Cardiology&Dongguan Division of Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Dongguan TCM Hospital, Dongguan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xian', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Xuan', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Tan', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jiyan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. chenjiyandr@126.com.""}, {'ForeName': 'Zhonghan', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. liuyongxueshu@139.com.""}]",The international journal of cardiovascular imaging,['10.1007/s10554-019-01730-6']
591,31326978,Associations of Hearing Loss and Menopausal Hormone Therapy With Change in Global Cognition and Incident Cognitive Impairment Among Postmenopausal Women.,"BACKGROUND


Hearing loss (HL) and menopausal hormone therapy (conjugated equine estrogens [CEE] and/or medroxyprogesterone acetate [MPA]) are separately associated with cognitive decline and increased risk of incident cognitive impairment. Joint effects of HL and HT could be associated with additive or synergistic decline in global cognition and risk of incident cognitive impairment among postmenopausal women.
METHODS


Using the Women's Health Initiative (WHI) Memory Study, 7,220 postmenopausal women with measures of HL, global cognition (Modified Mini-Mental State Examination score), and cognitive impairment (centrally adjudicated diagnoses of mild cognitive impairment and dementia) from 1996 to 2009. Multivariable linear mixed-effects models were used to analyze rate of change in global cognition. Accelerated failure time models were used to evaluate time to incident cognitive impairment, stratified by HT.
RESULTS


Within the CEE-Alone trial, observed adverse effects of CEE-Alone on change in global cognition did not differ by HL, and estimated joint effects of HL and CEE-Alone were not associated with incident cognitive impairment. Within the CEE+MPA trial, while HL did not independently accelerate time to cognitive impairment, the adverse effect of CEE+MPA on global cognition was heightened in older women with HL. Older women on CEE+MPA either with HL (time ratio [TR] = 0.82, 95% confidence interval [CI]: 0.71, 0.94) or with normal hearing (TR = 0.86, 95% CI: 0.76, 0.97) had faster time to cognitive impairment than those with normal hearing and placebo.
CONCLUSIONS


HL may accentuate the adverse effect of CEE+MPA, not CEE-Alone, on global cognitive decline, not incident cognitive impairment, among postmenopausal women on HT.",2020,"Joint effects of HL and HT could be associated with additive or synergistic decline in global cognition and risk of incident cognitive impairment among postmenopausal women.
","['postmenopausal women', '7,220 postmenopausal women with measures of HL, global cognition (Modified Mini- Mental State Examination score), and cognitive impairment (centrally-adjudicated diagnoses of mild cognitive impairment and dementia) from 1996-2009', 'Postmenopausal Women', 'postmenopausal women on HT', 'older women with HL', 'Older women on']","['HL and HT', 'Menopausal Hormone Therapy', 'medroxyprogesterone acetate [MPA', 'CEE+MPA']","['incident cognitive impairment', 'normal hearing', 'rate of change in global cognition', 'global cognition', 'faster time to cognitive impairment']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4304091', 'cui_str': '3MS (Modified Mini-Mental State) Examination score'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.094197,"Joint effects of HL and HT could be associated with additive or synergistic decline in global cognition and risk of incident cognitive impairment among postmenopausal women.
","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Armstrong', 'Affiliation': 'Laboratory of Behavioral Neuroscience, National Institute of Aging, Baltimore, Maryland.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jiu-Chiuan', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Preventive Medicine and Neurology, Keck School of Medicine of University of Southern California, Los Angeles, California.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Masaki', 'Affiliation': 'Department of Geriatric Medicine, John A. Burns School of Medicine, University of Hawai`i Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wactawski-Wende', 'Affiliation': 'Department of Epidemiology and Environmental Health, School of Public Health and Health Professions, University of Buffalo, New York.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.'}, {'ForeName': 'Margery L S', 'Initials': 'MLS', 'LastName': 'Gass', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Marcia L', 'Initials': 'ML', 'LastName': 'Stefanick', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Deal', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Frank R', 'Initials': 'FR', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Resnick', 'Affiliation': 'Laboratory of Behavioral Neuroscience, National Institute of Aging, Baltimore, Maryland.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz173']
592,32285195,The Utility of Diaphragm Ultrasound in Reducing Time to Extubation.,"PURPOSE


Prediction of optimal timing for extubation of mechanically ventilated patients is challenging. Ultrasound measures of diaphragm thickness or diaphragm dome excursion have been used to aid in predicting extubation success or failure. The aim of this study was to determine if incorporating results of diaphragm ultrasound into usual ICU care would shorten the time to extubation.
METHODS


We performed a prospective, randomized, controlled study at three Brown University teaching hospitals. Included subjects underwent block randomization to either usual care (Control) or usual care enhanced with ultrasound measurements of the diaphragm (Intervention). The primary outcome was the time to extubation after ultrasound, and the secondary outcome was the total days on the ventilator. Only intensivists in the Intervention group would have the ultrasound information on the likelihood of successful extubation available to incorporate with traditional clinical and physiologic measures to determine the timing of extubation.
RESULTS


A total of 32 subjects were studied; 15 were randomized into the Control group and 17 into the Intervention group. The time from ultrasound to extubation was significantly reduced in the Intervention group compared to the Control group in patients with a ∆tdi% ≥ 30% (4.8 ± 8.4 vs 35.0 ± 41.0 h, p = 0.04). The time from ultrasound to extubation was shorter in subjects with a normally functioning diaphragm (∆tdi% ≥ 30%) compared to those with diaphragm dysfunction (∆tdi% < 30%) (23.2 ± 35.2 vs 57.3 ± 52.0 h p = 0.046). When combining the Intervention and Control groups, a value of ∆tdi% ≥ 30% for extubation success at 24 h provided a sensitivity, specificity, PPV and NPV of 90.9%, 86.7%, 90.9%, and 86.7%, respectively.
CONCLUSIONS


Diaphragm ultrasound evaluation of ∆tdi% aids in reducing time to extubation.",2020,"The time from ultrasound to extubation was significantly reduced in the Intervention group compared to the Control group in patients with a ∆tdi% ≥ 30% (4.8 ± 8.4 vs 35.0 ± 41.0 h, p = 0.04).","['three Brown University teaching hospitals', 'mechanically ventilated patients', 'A total of 32 subjects were studied; 15']","['Diaphragm Ultrasound', 'diaphragm ultrasound into usual ICU care', 'usual care (Control) or usual care enhanced with ultrasound measurements of the diaphragm (Intervention']","['time to extubation', 'sensitivity, specificity, PPV and NPV', 'total days on the ventilator', 'time from ultrasound to extubation', 'time to extubation after ultrasound']","[{'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0028586', 'cui_str': 'Nucleopolyhedrovirus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",32.0,0.0729494,"The time from ultrasound to extubation was significantly reduced in the Intervention group compared to the Control group in patients with a ∆tdi% ≥ 30% (4.8 ± 8.4 vs 35.0 ± 41.0 h, p = 0.04).","[{'ForeName': 'F Dennis', 'Initials': 'FD', 'LastName': 'McCool', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Dennis O', 'Initials': 'DO', 'LastName': ""Oyieng'o"", 'Affiliation': ', 3311 E Murdock St 3rd floor, Wichita, KS, 67208, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Koo', 'Affiliation': 'University of Tennessee College of Medicine Chattanooga, Baroness Erlanger Hospital, 975 E 3rd Street, C-735, Chattanooga, TN, 37403, USA. drpkoo@gmail.com.'}]",Lung,['10.1007/s00408-020-00352-3']
593,32159882,Safety and efficacy of first-line dacomitinib in Japanese patients with advanced non-small cell lung cancer.,"In a subgroup of Japanese patients in the ARCHER 1050 randomized phase 3 trial, we evaluated the efficacy and safety and determined the effects of dose modifications on adverse events (AE) and therapy management of first-line oral dacomitinib 45 mg compared with oral gefitinib 250 mg, each once daily in 28-d cycles, in patients with EGFR-activating mutation-positive (EGFR-positive; exon 19 deletion or exon 21 L858R substitution mutations) advanced non-small cell lung cancer (NSCLC). The primary endpoint was progression-free survival (PFS; RECIST, version 1.1, by blinded independent review). In 81 Japanese patients (40 dacomitinib, 41 gefitinib), PFS was longer with dacomitinib compared with gefitinib (hazard ratio [HR], 0.544 [95% confidence interval {CI}, 0.307-0.961]; 2-sided P = .0327; median 18.2 for dacomitinib [95% CI, 11.0-31.3] mo, 9.3 [95% CI, 7.4-14.7] mo for gefitinib). The most common Grade 3 AEs were dermatitis acneiform with dacomitinib (27.5%) and increased alanine aminotransferase with gefitinib (12.2%). A higher proportion of patients receiving dacomitinib (85.0%) compared with gefitinib (24.4%) had AEs leading to dose reduction. Incidence and severity of diarrhea, dermatitis acneiform, stomatitis and paronychia were generally reduced after dacomitinib dose reductions and dacomitinib treatment duration was generally longer in patients with a dose reduction in comparison with those without a dose reduction. Our results confirmed the efficacy and safety of first-line dacomitinib in Japanese patients with EGFR-positive advanced NSCLC.",2020,"Incidence and severity of diarrhea, dermatitis acneiform, stomatitis and paronychia were generally reduced after dacomitinib dose reductions and dacomitinib treatment duration was generally longer in patients with a dose reduction in comparison with those without a dose reduction.","['81 Japanese patients', 'Japanese patients with EGFR-positive advanced NSCLC', 'Japanese patients with advanced non-small cell lung cancer']","['first-line dacomitinib', 'oral gefitinib', 'EGFR-activating mutation-positive (EGFR-positive; exon 19 deletion or exon 21 L858R substitution mutations) advanced non-small cell lung cancer (NSCLC']","['Safety and efficacy', 'progression-free survival', 'efficacy and safety', 'alanine aminotransferase', 'Incidence and severity of diarrhea, dermatitis acneiform, stomatitis and paronychia', 'dermatitis acneiform with dacomitinib']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C2987430'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0234894', 'cui_str': 'Dermatitis acneiform'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C2987430'}]",81.0,0.130685,"Incidence and severity of diarrhea, dermatitis acneiform, stomatitis and paronychia were generally reduced after dacomitinib dose reductions and dacomitinib treatment duration was generally longer in patients with a dose reduction in comparison with those without a dose reduction.","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Thoracic Oncology, Kanagawa Cancer Center, Kanagawa, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Niho', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Nogami', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Kaneda', 'Affiliation': 'Department of Clinical Oncology, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wilner', 'Affiliation': 'Pfizer Oncology, La Jolla, CA, USA.'}, {'ForeName': 'Mizuki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Isozaki', 'Affiliation': 'Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Wada', 'Affiliation': 'Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Fumito', 'Initials': 'F', 'LastName': 'Tsuji', 'Affiliation': 'SFJ Pharma Japan, Osaka, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.'}]",Cancer science,['10.1111/cas.14384']
594,32216524,"Effects of strength training on physical fitness and sport-specific performance in recreational, sub-elite, and elite rowers: A systematic review with meta-analysis.","The purpose of this systematic review with meta-analysis was to examine the effects of strength training (ST) on selected components of physical fitness (e.g., lower/upper limb maximal strength, muscular endurance, jump performance, cardiorespiratory endurance) and sport-specific performance in rowers. Only studies with an active control group were included if they examined the effects of ST on at least one proxy of physical fitness and/or sport-specific performance in rowers. Weighted and averaged standardized mean differences (SMD) were calculated using random-effects models. Subgroup analyses were computed to identify effects of ST type or expertise level on sport-specific performance. Our analyses revealed significant small effects of ST on lower limb maximal strength (SMD = 0.42, p = 0.05) and on sport-specific performance (SMD = 0.32, p = 0.05). Non-significant effects were found for upper limb maximal strength, upper/lower limb muscular endurance, jump performance, and cardiorespiratory endurance. Subgroup analyses for ST type and expertise level showed non-significant differences between the respective subgroups of rowers (p ≥ 0.32). Our systematic review with meta-analysis indicated that ST is an effective means for improving lower limb maximal strength and sport-specific performance in rowers. However, ST-induced effects are neither modulated by ST type nor rowers' expertise level.
ABBREVIATIONS


CON: control group; ICC: intraclass correlation coefficient; CRE: cardiorespiratory endurance; F: female; IG: intervention group; INT: intervention group; M: male; Sets: number of sets per exercise; SMD: standardized mean differences; SMD wm : weighted mean SMD; ST: strength training; RCT: randomized controlled trial; Reps: repetitions; RM: repetition maximum; TF: training frequency (times per week); TI: training intensity (eg., % of 1 repetition maximum); TP: training periods (weeks).",2020,"Non-significant effects were found for upper limb maximal strength, upper/lower limb muscular endurance, jump performance, and cardiorespiratory endurance.","['rowers', 'recreational, sub-elite, and elite rowers']","['strength training', 'ST', 'strength training (ST']","['lower limb maximal strength', 'upper limb maximal strength, upper/lower limb muscular endurance, jump performance, and cardiorespiratory endurance', 'physical fitness (e.g., lower/upper limb maximal strength, muscular endurance, jump performance, cardiorespiratory endurance) and sport-specific performance', 'sport-specific performance', 'ST type and expertise level', 'physical fitness and sport-specific performance']","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0203292,"Non-significant effects were found for upper limb maximal strength, upper/lower limb muscular endurance, jump performance, and cardiorespiratory endurance.","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Thiele', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognitive Sciences, University of Potsdam , Potsdam, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Prieske', 'Affiliation': 'Professorship for Exercise and Movement, University of Applied Sciences for Sports and Management Potsdam , Potsdam, Germany.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Chaabene', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognitive Sciences, University of Potsdam , Potsdam, Germany.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognitive Sciences, University of Potsdam , Potsdam, Germany.'}]",Journal of sports sciences,['10.1080/02640414.2020.1745502']
595,32091593,Child-level evaluation of a web-based intervention to improve dietary guideline implementation in childcare centers: a cluster-randomized controlled trial.,"BACKGROUND


Although it is recommended that childcare centers provide foods consistent with dietary guidelines, the impact of implementing sector-specific guidelines on child outcomes is largely unknown.
OBJECTIVES


This study aims to examine the impact of a web-based program and support to implement dietary guidelines in childcare centers on children's 1) diet; 2) BMI z scores; and 3) child health-related quality of life (HRQoL).
METHODS


This study was a cluster-randomized controlled trial utilizing a Type-3 Hybrid implementation-effectiveness design conducted between October 2016 and March 2018. This study reports on child outcomes. Fifty-four childcare centers in New South Wales, Australia were randomly assigned to the intervention (a web-based menu-planning tool and support) or control group (usual care). The intervention was designed to address barriers and enablers to dietary guideline implementation according to the Theoretical Domains Framework. A quota of 35 consenting childcare centers undertook child-level evaluation of dietary intake where 522 parents consented to completing ≥1 component of data collection for their child. Child consumption of core and discretionary (unhealthy) foods while in care was assessed via dietary observations by blinded research assistants, childcare diet quality was assessed via educator-completed questionnaires, BMI z scores were assessed via measured weight and height, and child HRQoL was assessed via parent report at baseline and 12-mo follow-up.
RESULTS


There was a significant increase in mean child consumption of fruit (0.39 servings; 95% CI: 0.12, 0.65 servings) and dairy foods (0.38 servings; 95% CI: 0.19, 0.57 servings) and a significant reduction in consumption of discretionary foods (-0.40 servings; 95% CI: -0.64, -0.16 servings) in care in the intervention group, relative to control at 12-mo follow-up. No significant differences were observed in diet quality, BMI z scores, or HRQoL.
CONCLUSIONS


A web-based intervention to support planning of childcare menus consistent with dietary guidelines can improve child consumption of healthier foods in daycare. This trial was registered at www.anzctr.org.au as ACTRN12616000974404.",2020,"No significant differences were observed in diet quality, BMI z scores, or HRQoL.
CONCLUSIONS


A web-based intervention to support planning of childcare menus consistent with dietary guidelines can improve child consumption of healthier foods in daycare.","['October 2016 and March 2018', 'childcare centers', 'Fifty-four childcare centers in New South Wales, Australia', '35 consenting childcare centers undertook child-level evaluation of dietary intake where 522 parents consented to completing ≥1 component of data collection for their child', ""childcare centers on children's 1) diet; 2""]","['intervention (a web-based menu-planning tool and support) or control group (usual care', 'web-based program and support to implement dietary guidelines', 'web-based intervention to improve dietary guideline implementation']","['consumption of discretionary foods', 'weight and height, and child HRQoL', 'child consumption of healthier foods in daycare', 'mean child consumption of fruit', 'diet quality, BMI z scores', 'BMI z scores; and 3) child health-related quality of life (HRQoL']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C4517804', 'cui_str': 'Five hundred and twenty-two'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C3658297', 'cui_str': 'Nutrition Guidelines'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.136214,"No significant differences were observed in diet quality, BMI z scores, or HRQoL.
CONCLUSIONS


A web-based intervention to support planning of childcare menus consistent with dietary guidelines can improve child consumption of healthier foods in daycare.","[{'ForeName': 'Sze Lin', 'Initials': 'SL', 'LastName': 'Yoong', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Grady', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Wiggers', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Fiona G', 'Initials': 'FG', 'LastName': 'Stacey', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rissel', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Flood', 'Affiliation': 'Western Sydney Local Health District, Westmead, New South Wales, Australia.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Finch', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wyse', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Salajan', 'Affiliation': 'Healthy Australia Ltd, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': ""O'Rourke"", 'Affiliation': 'Healthy Australia Ltd, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Barnes', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pond', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gillham', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Green', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales, Australia.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa025']
596,30959514,Neurophysiological signature of gamma-hydroxybutyrate augmented sleep in male healthy volunteers may reflect biomimetic sleep enhancement: a randomized controlled trial.,"Gamma-hydroxybutyrate (GHB) is an endogenous GHB/GABA B  receptor agonist, which has demonstrated potency in consolidating sleep and reducing excessive daytime sleepiness in narcolepsy. Little is known whether GHB's efficacy reflects the promotion of physiological sleep mechanisms and no study has investigated its sleep consolidating effects under low sleep pressure. GHB (50 mg/kg p.o.) and placebo were administered in 20 young male volunteers at 2:30 a.m., the time when GHB is typically given in narcolepsy, in a randomized, double-blinded, crossover manner. Drug effects on sleep architecture and electroencephalographic (EEG) sleep spectra were analyzed. In addition, current source density (CSD) analysis was employed to identify the effects of GHB on the brain electrical sources of neuronal oscillations. Moreover, lagged-phase synchronization (LPS) analysis was applied to quantify the functional connectivity among sleep-relevant brain regions. GHB prolonged slow-wave sleep (stage N3) at the cost of rapid eye movement (REM) sleep. Furthermore, it enhanced delta-theta (0.5-8 Hz) activity in NREM and REM sleep, while reducing activity in the spindle frequency range (13-15 Hz) in sleep stage N2. The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex. Theta power was particularly increased in the prefrontal cortex and both temporal poles. Moreover, the brain areas that showed increased theta power after GHB also exhibited increased lagged-phase synchronization among each other. Our study in healthy men revealed distinct similarities between GHB-augmented sleep and physiologically augmented sleep as seen in recovery sleep after prolonged wakefulness. The promotion of the sleep neurophysiological mechanisms by GHB may thus provide a rationale for GHB-induced sleep and waking quality in neuropsychiatric disorders beyond narcolepsy.",2019,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","['20 young male volunteers', 'healthy men', 'male healthy volunteers']","['gamma-hydroxybutyrate augmented sleep', 'placebo', 'GHB', 'Gamma-hydroxybutyrate (GHB']","['sleep architecture and electroencephalographic (EEG) sleep spectra', 'delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex', 'biomimetic sleep enhancement', 'GHB prolonged slow-wave sleep (stage N3', 'Theta power']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0228243', 'cui_str': 'Gyrus Fusiformis'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0872312', 'cui_str': 'Biomimicry Engineering'}, {'cui': 'C0184578', 'cui_str': 'Sleep/wake cycle facilitation'}, {'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",20.0,0.0596478,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","[{'ForeName': 'Dario A', 'Initials': 'DA', 'LastName': 'Dornbierer', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland. dornbierer@pharma.uzh.ch.'}, {'ForeName': 'Diego M', 'Initials': 'DM', 'LastName': 'Baur', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Stucky', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Forensic Pharmacology and Toxicology, Zurich Institute of Forensic Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Oliver G', 'Initials': 'OG', 'LastName': 'Bosch', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Landolt', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0382-z']
597,32286711,"Effects of continuous and intermittent aerobic physical training on hormonal and metabolic profile, and body composition in women with polycystic ovary syndrome: A randomized controlled trial.","OBJECTIVE


To evaluate the effects of continuous (CA) and intermittent (IA) aerobic training on hormonal and metabolic parameters and body composition of women with polycystic ovary syndrome (PCOS).
DESIGN


Prospective, interventional, randomized study.
METHODS


Randomized controlled training (RCT) with sample allocation and stratification into three groups: CAT (n = 28) and IAT (n = 29) training and no training [control (CG), n = 30]. Before and after 16 weeks of intervention (CAT or IAT) or observation (CG), hormonal and metabolic parameters, body composition and anthropometric indices were evaluated. Aerobic physical training on a treadmill consisted of 30- to 50-minute sessions with intensities ranging from 60% to 90% of the maximum heart rate.
RESULTS


In the CA group, there was reduction in waist circumference (WC) (P = .045), hip circumference (P = .032), cholesterol (P ≤ .001), low-density lipoprotein (P = .030) and testosterone (P ≤ .001). In the IAT group, there was a reduction in WC (P = .014), waist-to-hip ratio (P = .012), testosterone (P = .019) and the free androgen index (FAI) (P = .037). The CG showed increases in WC (P = .049), total body mass (P = .015), body fat percentage (P = .034), total mass of the arms (P ≤ .001), trunk fat percentage (P = .033), leg fat percentage (P = .021) and total gynoid mass (P = .011).
CONCLUSION


CAT and IAT training reduced anthropometric indices and hyperandrogenism in PCOS, whereas only IAT training reduced the FAI. Furthermore, only CAT training improved the lipid profile.",2020,"In the CA group, there was reduction in waist circumference (WC) (p = 0.045), hip circumference (p = 0.032), cholesterol (p ≤ 0.001), low-density lipoprotein (p = 0.030), and testosterone (p ≤ 0.001).","['women with polycystic ovary syndrome', 'women with polycystic ovary syndrome (PCOS']","['CAT and IAT training', 'continuous and intermittent aerobic physical training', 'Aerobic physical training', 'IAT (n = 29) training and no training [control (CG', 'continuous (CA) and intermittent (IA) aerobic training']","['cholesterol', 'total gynoid mass', 'leg fat percentage', 'waist circumference (WC', 'hormonal and metabolic profile, and body composition', 'reduction in WC', 'waist-to-hip ratio', 'free androgen index (FAI', 'body fat percentage', 'total mass', 'hip circumference', 'WC', 'trunk fat percentage', 'lipid profile', 'low-density lipoprotein', 'total body mass']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]",,0.0782393,"In the CA group, there was reduction in waist circumference (WC) (p = 0.045), hip circumference (p = 0.032), cholesterol (p ≤ 0.001), low-density lipoprotein (p = 0.030), and testosterone (p ≤ 0.001).","[{'ForeName': 'Victor B', 'Initials': 'VB', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Gislaine Satyko', 'Initials': 'GS', 'LastName': 'Kogure', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Iris Palma', 'Initials': 'IP', 'LastName': 'Lopes', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Rafael C', 'Initials': 'RC', 'LastName': 'Silva', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Daiana Cristina Chielli', 'Initials': 'DCC', 'LastName': 'Pedroso', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Anderson S', 'Initials': 'AS', 'LastName': 'de Melo', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Hugo C D', 'Initials': 'HCD', 'LastName': 'de Souza', 'Affiliation': 'Department of Biomechanics, Medicine and Rehabilitation of the Locomotor Apparatus, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP), Ribeirão Preto, Brazil.'}, {'ForeName': 'Rui Alberto', 'Initials': 'RA', 'LastName': 'Ferriani', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Cristiana Libardi', 'Initials': 'CL', 'LastName': 'Miranda Furtado', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}, {'ForeName': 'Rosana Maria', 'Initials': 'RM', 'LastName': 'Dos Reis', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP) Ribeirão Preto, Ribeirão Preto, Brazil.'}]",Clinical endocrinology,['10.1111/cen.14194']
598,31950134,Effect of vitamin D3 supplementation on vascular and metabolic health of vitamin D-deficient overweight and obese children: a randomized clinical trial.,"BACKGROUND


Obese children are vulnerable to vitamin D deficiency and impaired cardiovascular health; vitamin D replenishment might improve their cardiovascular health.
OBJECTIVES


The aims were to determine, in vitamin D-deficient overweight and obese children, whether supplementation with vitamin D3 1000 or 2000 IU/d is more effective than 600 IU/d in improving arterial endothelial function, arterial stiffness, central and systemic blood pressure (BP), insulin sensitivity (1/fasting insulin concentration), fasting glucose concentration, and lipid profile and to explore whether downregulation of adipocytokines and markers of systemic inflammation underlies vitamin D effects.
METHODS


We conducted a randomized, double-masked, controlled clinical trial in 225 10- to 18-y-old eligible children. Change in endothelial function at 6 mo was the primary outcome.
RESULTS


Dose-response increases in serum 25-hydroxyvitamin D concentrations were significant and tolerated without developing hypercalcemia. Changes at 3 and 6 mo in endothelial function, arterial stiffness, systemic-systolic BP, lipids, and inflammatory markers did not differ between children receiving 1000 or 2000 IU vitamin D and children receiving 600 IU. Some secondary outcomes differed between groups. Compared with the 600-IU group, central-systolic, central-diastolic, and systemic-diastolic BP was lower at 6 mo in the 1000-IU group [-2.66 (95% CI: -5.27, -0.046), -3.57 (-5.97, -1.17), and -3.28 (-5.55, -1.00) mm Hg, respectively]; insulin sensitivity increased at 3 and 6 mo and fasting glucose concentration declined at 6 mo (-2.67; 95% CI: -4.88, -0.46 mg/dL) in the 2000-IU group.
CONCLUSIONS


Correction of vitamin D deficiency in overweight and obese children by vitamin D3 supplementation with 1000 or 2000 IU/d versus 600 IU/d did not affect measures of arterial endothelial function or stiffness, systemic inflammation, or lipid profile, but resulted in reductions in BP and fasting glucose concentration and in improvements in insulin sensitivity. Optimization of children's vitamin D status may improve their cardiovascular health. This trial was registered at clinicaltrials.gov as NCT01797302.",2020,"Compared with the 600-IU group, central-systolic, central-diastolic, and systemic-diastolic BP was lower at 6 mo in the 1000-IU group [-2.66 (95% CI: -5.27, -0.046), -3.57","['vitamin D-deficient overweight and obese children', 'Obese children', 'deficient overweight and obese children', '225 10- to 18-y-old eligible children', 'overweight and obese children']","['vitamin D', 'vitamin D3 supplementation', 'supplementation with vitamin D3']","['arterial endothelial function or stiffness, systemic inflammation, or lipid profile', 'fasting glucose concentration', 'insulin sensitivity', 'central-systolic, central-diastolic, and systemic-diastolic BP', '25-hydroxyvitamin D concentrations', 'arterial endothelial function, arterial stiffness, central and systemic blood pressure (BP), insulin sensitivity (1/fasting insulin concentration), fasting glucose concentration, and lipid profile', 'serum', 'endothelial function', 'BP and fasting glucose concentration', 'vascular and metabolic health', 'endothelial function, arterial stiffness, systemic-systolic BP, lipids, and inflammatory markers']","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.646145,"Compared with the 600-IU group, central-systolic, central-diastolic, and systemic-diastolic BP was lower at 6 mo in the 1000-IU group [-2.66 (95% CI: -5.27, -0.046), -3.57","[{'ForeName': 'Kumaravel', 'Initials': 'K', 'LastName': 'Rajakumar', 'Affiliation': ""Department of Pediatrics, University of Pittsburgh School of Medicine, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Charity G', 'Initials': 'CG', 'LastName': 'Moore', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Arshad T', 'Initials': 'AT', 'LastName': 'Khalid', 'Affiliation': ""Department of Pediatrics, University of Pittsburgh School of Medicine, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Abbe N', 'Initials': 'AN', 'LastName': 'Vallejo', 'Affiliation': ""Department of Pediatrics, University of Pittsburgh School of Medicine, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Virji', 'Affiliation': 'Department of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Holick', 'Affiliation': 'Department of Medicine, Boston University Medical Center, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Greenspan', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Arslanian', 'Affiliation': ""Department of Pediatrics, University of Pittsburgh School of Medicine, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Reis', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz340']
599,32283645,Fecal Recovery of Probiotics Administered as a Multi-Strain Formulation during Antibiotic Treatment.,"The present study aimed to investigate whether probiotic recovery is affected when consumed together with antibiotics. Fecal samples were collected from an earlier antibiotic associated diarrhea, randomized, placebo-controlled study with a product consisting of a combination of  Lactobacillus acidophilus  NCFM,  Lactobacillus paracasei  Lpc-37, and  Bifidobacterium lactis  Bi-07,  B. lactis  Bl-04 at equal numbers and at a total dose of 10 10  CFU. Fecal samples were collected during the screening visit (T0), i.e., at the time of antibiotic prescription, and then on the last day of the antibiotic treatment (T1) as well as seven days after the subject had stopped taking the antibiotic treatment (T2) and at two weeks after completing antibiotic treatment and one week after probiotic/placebo consumption stopped (T3). Samples were analyzed for the presence of the four administered strains. The study was registered at clinicaltrials.gov as NCT01596829. Detection levels of all four strains were significantly increased from T0 to T1 and returned to baseline level from T2 to T3. There were also significantly more subjects with detectable levels of  L. paracasei  Lpc-37,  B. lactis  Bi-07, and  B. lactis  Bl-04 at T1 and T2 compared to T0 and T3, and compared to placebo. Each of the four strains could be detected in the feces of patients apparently unaffected by the simultaneous consumption of antibiotics.",2020,Detection levels of all four strains were significantly increased from T0 to T1 and returned to baseline level from T2 to T3.,[],['placebo'],['Detection levels'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",10.0,0.0780496,Detection levels of all four strains were significantly increased from T0 to T1 and returned to baseline level from T2 to T3.,"[{'ForeName': 'Sofia D', 'Initials': 'SD', 'LastName': 'Forssten', 'Affiliation': 'DuPont Nutrition and Biosciences, Sokeritehtaantie 20, 02460 Kantvik, Finland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Yeung', 'Affiliation': 'DuPont Nutrition and Biosciences, Sokeritehtaantie 20, 02460 Kantvik, Finland.'}, {'ForeName': 'Arthur C', 'Initials': 'AC', 'LastName': 'Ouwehand', 'Affiliation': 'DuPont Nutrition and Biosciences, Sokeritehtaantie 20, 02460 Kantvik, Finland.'}]",Biomedicines,['10.3390/biomedicines8040083']
600,32140704,Vitamin D status and cardiometabolic risk markers in young Swedish children: a double-blind randomized clinical trial comparing different doses of vitamin D supplements.,"BACKGROUND


Observational studies have linked low vitamin D status to unfavorable cardiometabolic risk markers, but double-blinded vitamin D intervention studies in children are scarce.
OBJECTIVES


The aim was to evaluate the effect of different doses of a vitamin D supplement on cardiometabolic risk markers in young healthy Swedish children with fair and dark skin.
METHODS


Cardiometabolic risk markers were analyzed as secondary outcomes of a double-blind, randomized, milk-based vitamin D intervention trial conducted during late fall and winter in 2 areas of Sweden (latitude 63°N and 55°N, respectively) in both fair- and dark-skinned 5- to 7-y-old children. During the 3-mo intervention, 206 children were randomly assigned to a daily milk-based vitamin D3 supplement of either 10 or 25 µg or placebo (2 µg; only at 55°N). Anthropometric measures, blood pressure, serum 25-hydroxyvitamin D [25(OH)D], total cholesterol, HDL cholesterol, apoA-I, apoB, and C-reactive protein (CRP) were analyzed and non-HDL cholesterol calculated at baseline and after the intervention.
RESULTS


At baseline, serum 25(OH)D was negatively associated with systolic and diastolic blood pressure (β = -0.194; 95% CI: -0.153, -0.013; and β = -0.187; 95% CI: -0.150, -0.011, respectively). At follow-up, there was no statistically significant difference in any of the cardiometabolic markers between groups.
CONCLUSIONS


We could not confirm any effect of vitamin D supplementation on serum lipids, blood pressure, or CRP in healthy 5- to 7-y-old children. The study was registered at clinicaltrials.gov (NCT01741324).",2020,"We could not confirm any effect of vitamin D supplementation on serum lipids, blood pressure, or CRP in healthy 5- to 7-y-old children.","['trial conducted during late fall and winter in 2 areas of Sweden (latitude 63°N and 55°N, respectively) in both fair- and dark-skinned 5- to 7-y-old children', 'young healthy Swedish children with fair and dark skin', 'healthy 5- to 7-y-old children', '206 children', 'young Swedish children']","['vitamin D supplementation', 'milk-based vitamin D intervention', 'vitamin D supplement', 'daily milk-based vitamin D3 supplement of either 10 or 25\xa0µg or placebo', 'vitamin D supplements']","['systolic and diastolic blood pressure', 'serum lipids, blood pressure, or CRP', 'cardiometabolic markers', 'cardiometabolic risk markers', 'HDL cholesterol calculated', 'Anthropometric measures, blood pressure, serum 25-hydroxyvitamin D [25(OH)D], total cholesterol, HDL cholesterol, apoA-I, apoB, and C-reactive protein (CRP', 'Vitamin D status and cardiometabolic risk markers']","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0332582', 'cui_str': 'Dark color (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0756567', 'cui_str': 'apoA-I(Zavalla)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",206.0,0.54295,"We could not confirm any effect of vitamin D supplementation on serum lipids, blood pressure, or CRP in healthy 5- to 7-y-old children.","[{'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Öhlund', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Lind', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Hernell', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sven-Arne', 'Initials': 'SA', 'LastName': 'Silfverdal', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Liv', 'Affiliation': 'Section of Sustainable Health, Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Karlsland Åkeson', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Lund University, Lund, Sweden.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa031']
601,31103018,Neural and behavioral effects of oxytocin administration during theory of mind in schizophrenia and controls: a randomized control trial.,"Social cognitive impairments, including theory of mind (ToM), in schizophrenia more strongly predict functional outcomes than psychotic symptoms or nonsocial cognitive deficits. Despite their clinical importance, current medications do not improve these deficits. The current study investigated the hypothesis that oxytocin, a neuropeptide implicated in social behavior, would normalize neural abnormalities in schizophrenia during ToM, and that this normalization would correlate improvement in ToM behavior. In this cross-over, double-blind, and placebo-controlled functional magnetic resonance imaging study, a single dose of 40 IU of oxytocin was administered via nasal spray to male individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n = 23) and healthy controls (n = 25). Participants completed two ToM tasks in the scanner, the False Belief and Person Description tasks. During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls. Oxytocin, relative to placebo, significantly increased accuracy and rTPJ activation for ToM but not control stories in schizophrenia. Furthermore, a significant positive correlation was found between oxytocin induced increases in rTPJ activity and accuracy, indicating that oxytocin improved rTPJ activity in schizophrenia predicted behavioral improvement. Oxytocin also significantly improved connectivity between rTPJ and mPFC in schizophrenia. These findings suggest that rTPJ activity during ToM might be a potential neural target for the treatment of social cognitive deficits in schizophrenia.",2019,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","['schizophrenia and controls', 'male\xa0individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n\u2009=\u200923) and healthy controls (n\u2009=\u200925']","['Oxytocin', 'placebo', 'oxytocin']","['rTPJ activity and accuracy', 'accuracy and rTPJ activation', 'Social cognitive impairments, including theory of mind (ToM', 'connectivity', 'reduced accuracy, hypo-activity', 'rTPJ activity']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}]",,0.12082,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","[{'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'University of California, San Francisco, CA, USA. josh.woolley@ucsf.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0417-5']
602,31113987,"Efficacy and safety of esaxerenone (CS-3150) for the treatment of essential hypertension: a phase 2 randomized, placebo-controlled, double-blind study.","This was a phase 2, multicenter, randomized, double-blind, placebo-controlled, open-label comparator study to investigate the efficacy and safety of esaxerenone (CS-3150), a novel non-steroidal mineralocorticoid receptor blocker, in Japanese patients with essential hypertension. Eligible patients (n = 426) received esaxerenone (1.25, 2.5, or 5 mg/day), placebo, or eplerenone (50-100 mg/day) for 12 weeks. The primary efficacy endpoint was the change from baseline in sitting systolic and diastolic blood pressure (BP). Safety endpoints included adverse events and serum K +  elevation. There were significant dose-response reductions in the 2.5 and 5 mg/day esaxerenone groups for sitting BP (both p < 0.001) and 24-h BP (both p < 0.0001) compared with placebo, with a mean (95% confidence interval) change in sitting BP of -7.0 (-9.5 to -4.6)/-3.8 (-5.2 to -2.4) mmHg in the placebo group, and -10.7 (-13.2 to -8.2)/-5.0 (-6.4 to -3.6) mmHg, -14.3 (-16.8 to -11.9)/-7.6 (-9.1 to -6.2) mmHg, and -20.6 (-23.0 to -18.2)/ -10.4 (-11.8 to -9.0) mmHg for the 1.25, 2.5, and 5 mg/day esaxerenone groups, respectively, while the change was -17.4 (-19.9 to -15.0)/-8.5 (-9.9 to -7.1) mmHg for eplerenone. The incidence of adverse events was similar in all treatment groups. Serum K +  levels initially increased in proportion with esaxerenone dose but were stable from week 2 until week 12. Plasma esaxerenone concentration increased in proportion with the dose. In conclusion, esaxerenone is an effective and tolerable treatment option for patients with essential hypertension.",2019,Serum K +  levels initially increased in proportion with esaxerenone dose but were stable from week 2 until week 12.,"['essential hypertension', 'Japanese patients with essential hypertension', 'Eligible patients (n\u2009=\u2009426) received', 'patients with essential hypertension']","['placebo, or eplerenone', 'esaxerenone', 'esaxerenone (CS-3150', 'placebo']","['dose-response reductions', 'Plasma esaxerenone concentration', '24-h BP', 'Serum K +  levels', 'adverse events', 'sitting BP', 'Efficacy and safety', 'sitting systolic and diastolic blood pressure (BP', 'adverse events and serum K +  elevation']","[{'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C4278755', 'cui_str': 'CS-3150'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",,0.342126,Serum K +  levels initially increased in proportion with esaxerenone dose but were stable from week 2 until week 12.,"[{'ForeName': 'Sadayoshi', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Division of Nephrology, Endocrinology and Vascular Medicine, Department of Medicine, Tohoku University School of Medicine, Sendai, Japan. db554@med.tohoku.ac.jp.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Division of Endocrinology, Metabolism and Nephrology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Okuda', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Yamakawa', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}]",Journal of human hypertension,['10.1038/s41371-019-0207-x']
603,32069352,Leptin partially mediates the association between early-life nutritional supplementation and long-term glycemic status among women in a Guatemalan longitudinal cohort.,"BACKGROUND


Early-life exposure to improved nutrition is associated with decreased risk of diabetes but increased risk of obesity. Leptin positively correlates with adiposity and has glucose-lowering effects, thus it may mediate the association of early-life nutrition and long-term glycemic status.
OBJECTIVES


We aimed to investigate the role of leptin in the differential association between early-life nutrition and the risks of obesity and diabetes.
METHODS


We analyzed data from a Guatemalan cohort who were randomly assigned at the village level to receive nutritional supplements as children. We conducted mediation analysis to examine the role of leptin in the associations of early-life nutrition and adult cardiometabolic outcomes.
RESULTS


Among 1112 study participants aged (mean ± SD) 44.1 ± 4.2 y, 60.6% were women. Cardiometabolic conditions were common: 40.2% of women and 19.4% of men were obese, and 53.1% of women and 41.0% of men were hyperglycemic or diabetic. Median (IQR) leptin concentration was 15.2 ng/mL (10.2-17.3 ng/mL) in women and 2.7 ng/mL (1.3-5.3 ng/mL) in men. Leptin was positively correlated with BMI (Spearman's ρ was 0.6 in women, 0.7 in men). Women exposed to improved nutrition in early life had 2.8-ng/mL (95% CI: 0.3, 5.3 ng/mL) higher leptin and tended to have lower fasting glucose (-0.8 mmol/L; -1.8, 0.2 mmol/L, nonsignificant) than unexposed women. There were no significant differences in leptin (-0.7 ng/mL; -2.1, 0.8 ng/mL) or fasting glucose (0.2 mmol/L; -0.5, 0.9 mmol/L) in men exposed to improved nutrition in early life compared with unexposed men. Leptin mediated 34.9% of the pathway between early-life nutrition and fasting glucose in women. The mediation in women was driven by improved pancreatic β-cell function. We did not observe the mediation effect in men.
CONCLUSIONS


Leptin mediated the glucose-lowering effect of early-life nutrition in women but not in men.",2020,"There were no significant differences in leptin (-0.7 ng/mL; -2.1, 0.8 ng/mL) or fasting glucose (0.2 mmol/L; -0.5, 0.9 mmol/L) in men exposed to improved nutrition in early life compared with unexposed men.","['men', 'women in a Guatemalan longitudinal cohort', 'women', 'women but not in men', '1112 study participants aged (mean\xa0±\xa0SD']",['nutritional supplements'],"['fasting glucose', 'pancreatic β-cell function', 'Leptin', 'leptin', 'Median (IQR) leptin concentration', 'Cardiometabolic conditions', 'hyperglycemic or diabetic']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]",1112.0,0.135746,"There were no significant differences in leptin (-0.7 ng/mL; -2.1, 0.8 ng/mL) or fasting glucose (0.2 mmol/L; -0.5, 0.9 mmol/L) in men exposed to improved nutrition in early life compared with unexposed men.","[{'ForeName': 'Siran', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Ngoc-Anh', 'Initials': 'NA', 'LastName': 'Le', 'Affiliation': 'Biomarker Core Laboratory, Foundation for Atlanta Veterans Education and Research, Atlanta Veterans Affairs Medical Center, Atlanta, GA, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ramirez-Zea', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama, Guatemala City, Guatemala.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Martorell', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'K M Venkat', 'Initials': 'KMV', 'LastName': 'Narayan', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa001']
604,32280089,Concentration-Dependent Activity of Hydromethylthionine on Clinical Decline and Brain Atrophy in a Randomized Controlled Trial in Behavioral Variant Frontotemporal Dementia.,"BACKGROUND


Hydromethylthionine is a potent inhibitor of pathological aggregation of tau and TDP-43 proteins.
OBJECTIVE


To compare hydromethylthionine treatment effects at two doses and to determine how drug exposure is related to treatment response in bvFTD.
METHODS


We undertook a 52-week Phase III study in 220 bvFTD patients randomized to compare hydromethylthionine at 200 mg/day and 8 mg/day (intended as a control). The principal outcomes were change on the Addenbrookes Cognitive Examination - Revised (ACE-R), the Functional Activities Questionnaire (FAQ), and whole brain volume. Secondary outcomes included Modified Clinical Global Impression of Change (Modified-CGIC). A population pharmacokinetic exposure-response analysis was undertaken in 175 of the patients with available blood samples and outcome data using a discriminatory plasma assay for the parent drug.
RESULTS


There were no significant differences between the two doses as randomized. There were steep concentration-response relationships for plasma levels in the range 0.3-0.6 ng/ml at the 8 mg/day dose on clinical and MRI outcomes. There were significant exposure-dependent differences at 8 mg/day for FAQ, Modified-CGIC, and whole brain atrophy comparing patients with plasma levels greater than 0.346 ng/ml with having minimal drug exposure. The exposure-response is biphasic with worse outcomes at the high concentrations produced by 200 mg/day.
CONCLUSIONS


Hydromethylthionine has a similar concentration-response profile for effects on clinical decline and brain atrophy at the 8 mg/day dose in bvFTD as recently reported in AD. Treatment responses in bvFTD are predicted to be maximal at doses in the range 20-60 mg/day. A confirmatory placebo-controlled trial is now planned.",2020,There were steep concentration-response relationships for plasma levels in the range 0.3-0.6 ng/ml at the 8 mg/day dose on clinical and MRI outcomes.,"['220 bvFTD patients', '176 of the patients with available blood samples and outcome data using a discriminatory plasma assay for the parent drug', 'Behavioral Variant Frontotemporal Dementia']","['hydromethylthionine', 'Hydromethylthionine', 'placebo']","['Modified Clinical Global Impression of Change (Modified-CGIC', 'steep concentration-response relationships for plasma levels', 'Addenbrookes Cognitive Examination - Revised (ACE-R), the Functional Activities Questionnaire (FAQ), and whole brain volume']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4011788', 'cui_str': 'Behavioral variant of frontotemporal dementia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",220.0,0.107878,There were steep concentration-response relationships for plasma levels in the range 0.3-0.6 ng/ml at the 8 mg/day dose on clinical and MRI outcomes.,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Shiells', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Bjoern O', 'Initials': 'BO', 'LastName': 'Schelter', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bentham', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Baddeley', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Rubino', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Ganesan', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hammel', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Vuksanovic', 'Affiliation': 'Aberdeen Biomedical Imaging Centre, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Roger T', 'Initials': 'RT', 'LastName': 'Staff', 'Affiliation': 'Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'Murray', 'Affiliation': 'Aberdeen Biomedical Imaging Centre, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Bracoud', 'Affiliation': 'Bioclinica, Lyon, France.'}, {'ForeName': 'Damon J', 'Initials': 'DJ', 'LastName': 'Wischik', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Riedel', 'Affiliation': 'School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gauthier', 'Affiliation': ""McGill Centre for Studies in Aging, Alzheimer's Disease Research Unit, and Douglas Mental Health University Institute, Montreal, QC, Canada.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': ""Beijing Institute for Brain Disorders Alzheimer's Disease Centre, Beijing, China.""}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Moebius', 'Affiliation': 'Moebius-Consult, Baar, Switzerland.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Hardlund', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Kipps', 'Affiliation': 'University Hospital Southampton and University of Southampton, UK.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kook', 'Affiliation': 'Salamandra LLC, Bethesda, MD, USA.'}, {'ForeName': 'John M D', 'Initials': 'JMD', 'LastName': 'Storey', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Harrington', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}, {'ForeName': 'Claude M', 'Initials': 'CM', 'LastName': 'Wischik', 'Affiliation': 'TauRx Therapeutics Ltd., Aberdeen, UK.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191173']
605,32281081,"[Lower Extremity Exercise Improves Functional Fitness, Physiological Indexes, Exercise Self-Efficacy, Sleep Quality, and Mental Health in Middle-Aged and Older Individuals].","BACKGROUND


Middle-aged and older individuals suffer from skeletal muscle loss due to aging, increasing the risk of sarcopenia. Muscular dystrophy reduces lower-extremity muscle endurance. The annual incidence of falls in the community is about 30-40%. Falls contribute to disability and fractures, affect quality of life, reduce mental health, and, in severe cases, result in death. Therefore, preventing lower limb muscle weakness in middle-aged and older individuals should be taken seriously.
PURPOSE


The purpose of this study was to promote community health with a focus on older, community-dwelling individuals. The effects of a lower-extremity exercise intervention on middle-aged and older individuals in terms of improving functional fitness, physiological indexes, exercise self-efficacy, sleep quality, and mental health were explored.
METHODS


This study used convenience sampling to recruit community residents over 55 years old as participants, with 50 participants assigned to the control group and to the experimental group, respectively. The experimental group participated in a 50-min lower extremity exercise intervention three times a week for 12 weeks. Differences in functional fitness, basic physiological index, exercise self-efficacy, sleep quality, and mental health variables between the two groups were assessed at the conclusion of the intervention.
RESULTS


The lower-extremity muscle exercise program significantly improved functional fitness, physiological indexes, exercise self-efficacy, sleep quality, and overall mental health status in the experimental group, as compared to the control group (p < .05).
CONCLUSIONS / IMPLICATIONS FOR PRACTICE


It is recommended that the concept and application of lower extremity movement intervention should be popularized among middle-aged and older individuals to promote physical and mental health, prevent the decline and loss of lower extremity muscle strength, and help realize healthy aging goals.",2020,"The lower-extremity muscle exercise program significantly improved functional fitness, physiological indexes, exercise self-efficacy, sleep quality, and overall mental health status in the experimental group, as compared to the control group (p < .05).
","['middle-aged and older individuals', 'Middle-aged and older individuals', 'community residents over 55 years old as participants, with 50 participants assigned to the control group and to the experimental group, respectively', 'community health with a focus on older, community-dwelling individuals']","['lower-extremity exercise intervention', '50-min lower extremity exercise intervention', 'Muscular dystrophy']","['quality of life, reduce mental health', 'extremity muscle endurance', 'functional fitness, physiological indexes, exercise self-efficacy, sleep quality, and mental health', 'functional fitness, physiological indexes, exercise self-efficacy, sleep quality, and overall mental health status', 'Lower Extremity Exercise Improves Functional Fitness, Physiological Indexes, Exercise Self-Efficacy, Sleep Quality, and Mental Health in Middle-Aged and Older Individuals', 'limb muscle weakness', 'functional fitness, basic physiological index, exercise self-efficacy, sleep quality, and mental health variables']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0026850', 'cui_str': 'Muscular dystrophy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0587246', 'cui_str': 'Muscle weakness of limb'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.0203585,"The lower-extremity muscle exercise program significantly improved functional fitness, physiological indexes, exercise self-efficacy, sleep quality, and overall mental health status in the experimental group, as compared to the control group (p < .05).
","[{'ForeName': 'Lan-Yin', 'Initials': 'LY', 'LastName': 'Jhang', 'Affiliation': 'MSN, RN, Department of Nurse, Lin Shin Hospital, Taiwan, ROC.'}, {'ForeName': 'Hsin-Shu', 'Initials': 'HS', 'LastName': 'Huang', 'Affiliation': 'EdD, RN, Associate Professor, Department of Nursing, Central Taiwan University of Science and Technology, Taiwan, ROC. hshuang@ctust.edu.tw.'}, {'ForeName': 'Yuannian', 'Initials': 'Y', 'LastName': 'Hsu', 'Affiliation': 'MD, Dean, Tao Yuan General Hospital, Ministry of Health and Welfare, Taiwan, ROC.'}, {'ForeName': 'Wen-Miao', 'Initials': 'WM', 'LastName': 'Liu', 'Affiliation': 'PhD, RN, Associate Professor, Department of Eldercare, Central Taiwan University of Science and Technology, Taiwan, ROC.'}]",Hu li za zhi The journal of nursing,['10.6224/JN.202004_67(2).06']
606,32020168,"Reformulation initiative for partial replacement of saturated with unsaturated fats in dairy foods attenuates the increase in LDL cholesterol and improves flow-mediated dilatation compared with conventional dairy: the randomized, controlled REplacement of SaturatEd fat in dairy on Total cholesterol (RESET) study.","BACKGROUND


Modifying dairy fat composition by increasing the MUFA content is a potential strategy to reduce dietary SFA intake for cardiovascular disease (CVD) prevention in the population.
OBJECTIVES


To determine the effects of consuming SFA-reduced, MUFA-enriched (modified) dairy products, compared with conventional dairy products (control), on the fasting cholesterol profile (primary outcome), endothelial function assessed by flow-mediated dilatation (FMD; key secondary outcome), and other cardiometabolic risk markers.
METHODS


A double-blind, randomized, controlled crossover 12-wk intervention was conducted. Participants with a 1.5-fold higher (moderate) CVD risk than the population mean replaced habitual dairy products with study products (milk, cheese, and butter) to achieve a high-fat, high-dairy isoenergetic daily dietary exchange [38% of total energy intake (%TE) from fat: control (dietary target: 19%TE SFA; 11%TE MUFA) and modified (16%TE SFA; 14%TE MUFA) diet].
RESULTS


Fifty-four participants (57.4% men; mean ± SEM age: 52 ± 3 y; BMI: 25.8 ± 0.5 kg/m2) completed the study. The modified diet attenuated the rise in fasting LDL cholesterol observed with the control diet (0.03 ± 0.06 mmol/L and 0.19 ± 0.05 mmol/L, respectively; P = 0.03). Relative to baseline, the %FMD response increased after the modified diet (0.35% ± 0.15%), whereas a decrease was observed after the control diet (-0.51% ± 0.15%; P< 0.0001). In addition, fasting plasma nitrite concentrations increased after the modified diet, yet decreased after the control diet (0.02 ± 0.01 μmol/L and -0.03 ± 0.02 μmol/L, respectively; P = 0.01).
CONCLUSIONS


In adults at moderate CVD risk, consumption of a high-fat diet containing SFA-reduced, MUFA-enriched dairy products for 12 wk showed beneficial effects on fasting LDL cholesterol and endothelial function compared with conventional dairy products. Our findings indicate that fatty acid modification of dairy products may have potential as a public health strategy aimed at CVD risk reduction. This trial was registered at clinicaltrials.gov as NCT02089035.",2020,"The modified diet attenuated the rise in fasting LDL cholesterol observed with the control diet (0.03 ± 0.06 mmol/L and 0.19 ± 0.05 mmol/L, respectively; P = 0.03).","['SEM age: 52\xa0±\xa03 y; BMI: 25.8\xa0±\xa00.5 kg/m2) completed the study', 'Participants with a 1.5-fold higher (moderate) CVD risk than the population mean replaced habitual dairy products with study products (milk, cheese, and butter', 'Fifty-four participants (57.4% men']","['consuming SFA-reduced, MUFA-enriched (modified) dairy products, compared with conventional dairy products (control']","['LDL cholesterol and improves flow-mediated dilatation', 'fasting LDL cholesterol', 'fasting LDL cholesterol and endothelial function', 'mean\xa0±', 'FMD response', 'fasting cholesterol profile (primary outcome), endothelial function assessed by flow-mediated dilatation (FMD; key secondary outcome), and other cardiometabolic risk markers', 'fasting plasma nitrite concentrations']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0010947', 'cui_str': 'Dairy Products'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0010947', 'cui_str': 'Dairy Products'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}]",54.0,0.185327,"The modified diet attenuated the rise in fasting LDL cholesterol observed with the control diet (0.03 ± 0.06 mmol/L and 0.19 ± 0.05 mmol/L, respectively; P = 0.03).","[{'ForeName': 'Dafni', 'Initials': 'D', 'LastName': 'Vasilopoulou', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Oonagh', 'Initials': 'O', 'LastName': 'Markey', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Kirsty E', 'Initials': 'KE', 'LastName': 'Kliem', 'Affiliation': 'Animal, Dairy and Food Chain Sciences, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Colette C', 'Initials': 'CC', 'LastName': 'Fagan', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Alistair S', 'Initials': 'AS', 'LastName': 'Grandison', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Humphries', 'Affiliation': 'Animal, Dairy and Food Chain Sciences, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Todd', 'Affiliation': 'Department of Mathematics and Statistics, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Kim G', 'Initials': 'KG', 'LastName': 'Jackson', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Givens', 'Affiliation': 'Institute for Food, Nutrition and Health, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Lovegrove', 'Affiliation': 'Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research, University of Reading, Reading, United Kingdom.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz344']
607,30822774,"Randomized, double-blind, placebo-controlled study of F17464, a preferential D 3  antagonist, in the treatment of acute exacerbation of schizophrenia.","F17464, a highly potent preferential D3 antagonist, is a novel compound in development for schizophrenia treatment. This phase II, double-blind, randomized, placebo-controlled, parallel-group study in five European countries evaluated the efficacy and safety of F17464, 20 mg twice daily, versus placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Change from baseline to Day 43 of the Positive and Negative Syndrome Scale (PANSS) total score was the primary outcome. The data from 134 randomized patients (67 per group) were analyzed (efficacy/safety). Using analysis of covariance (ANCOVA) after last observation carried forward (LOCF) imputation (primary analysis), the PANSS total score reduction was statistically significantly greater for F17464 than placebo treated subjects at endpoint (p = 0.014); using ANCOVA with Multiple Imputation (MI) method, the between-group difference was in favor of F17464 but did not reach statistical significance. Differences in PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria were also statistically significant in favor of F17464 (p values < 0.05) using the LOCF method, with similar results as for the primary analysis using the MI method. Treatment-related adverse events (AEs) were reported in 49.3% and 46.3% of patients on F17464 and placebo, respectively. The most common AEs in F17464 group: insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective was less frequent in F17464. Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464. This 6-week trial demonstrated therapeutic efficacy of 40 mg/day F17464 in improving symptoms of acute exacerbation of schizophrenia with a favorable safety profile.",2019,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","['acute exacerbation of schizophrenia', 'patients with acute exacerbation of schizophrenia']",['placebo'],"['weight gain, no extrapyramidal disorder except rare akathisia', 'insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective', 'PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria', 'adverse events (AEs', 'PANSS total score reduction', 'therapeutic efficacy', 'Positive and Negative Syndrome Scale (PANSS) total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0015371', 'cui_str': 'Extrapyramidal Disorders'}, {'cui': 'C0522498', 'cui_str': 'Uncommon (qualifier value)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0852908', 'cui_str': 'Drug ineffective'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}]",134.0,0.307203,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","[{'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Bitter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Semmelweis University, Balassa u.6, Budapest, 1083, Hungary.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'New York Presbyterian Hospital - Columbia University Medical Center, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Gaudoux', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Sokoloff', 'Affiliation': 'PSAdvice, Impasse Larosa, Ile-aux-Moines, 56780, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Groc', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chavda', 'Affiliation': ""Galderma, Rue D'Entre-deux-Villes 10, La Tour de Peilz, 1814, Switzerland.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Delsol', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Barthe', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Brunner', 'Affiliation': 'IRIS Servier, 50 rue Carot, Suresnes Cedex, 92284, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Fabre', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Fagard', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Montagne', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Tonner', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France. francoise.tonner@pierre-fabre.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0355-2']
608,32151708,Changes in serum estrogenic activity during neoadjuvant therapy with letrozole and exemestane.,"The aromatase inhibitors (AIs), letrozole (Femar®/Femara®) and exemestane (Aromasin®), are widely used to treat estrogen receptor (ER) positive breast cancer in postmenopausal patients. In the setting of metastatic breast cancer, these drugs may be used after another causing new responses in selected patients after progressing on the first choice. The precise explanation for this ""lack of cross resistance"" is still missing. NEOLETEXE is a neoadjuvant, randomized, open-label, cross-over trial. Postmenopausal patients with ER-positive, HER-2 negative, locally advanced breast cancer were enrolled. All patients were randomized to treatment starting with either letrozole or exemestane for at least 2 months followed by another 2 months on the alternative AI. The total estrogenic activities in blood samples were determined using the AroER tri-screen assay developed in the Chen laboratory. Using this highly sensitive assay, estrogenic activity was detected at three time points for all patients. Importantly, a significantly higher total estrogenic activity was found during therapy with exemestane compared to letrozole in 21 out of 26 patients. When letrozole was included in the AroER tri-screen assay, the estrogenic activities in most samples collected during exemestane treatment were further reduced, suggesting that low levels of androgens remained in specimens obtained after exemestane treatment. Our results suggest the AroER tri-screen to be a very sensitive method to estimate the overall estrogen-mediated activity in human samples even during therapy with highly potent aromatase inhibitors. In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.",2020,"In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.","['postmenopausal patients', 'Postmenopausal patients with ER-positive, HER-2 negative, locally advanced breast cancer were enrolled']","['letrozole', 'letrozole and exemestane', 'aromatase inhibitors (AIs), letrozole (Femar®/Femara®) and exemestane (Aromasin®', 'letrozole or exemestane', 'exemestane']","['total estrogenic activities in blood samples', 'serum estrogenic activity', 'estrogenic activity', 'serum estrogen activity', 'total estrogenic activity', 'estrogenic activities']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0876723', 'cui_str': 'Aromasin'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0857965', 'cui_str': 'Serum oestrogen'}]",26.0,0.0127101,"In the present study, serum estrogen activity was significantly higher during exemestane therapy when compared to letrozole therapy.","[{'ForeName': 'Nazli', 'Initials': 'N', 'LastName': 'Bahrami', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway; Department of Breast and Endocrine Surgery, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Kanaya', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Torill', 'Initials': 'T', 'LastName': 'Sauer', 'Affiliation': 'Department of Pathology, Akershus University Hospital, Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Campus AHUS, Norway.'}, {'ForeName': 'Daehoon', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': 'Department of Pathology, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Loeng', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Gravdehaug', 'Affiliation': 'Department of Breast and Endocrine Surgery, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Shiuan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Cancer Biology, Beckman Research Institute of the City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Geisler', 'Affiliation': 'Department of Oncology, Akershus University Hospital (AHUS), Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Campus AHUS, Norway. Electronic address: juergen.geisler@medisin.uio.no.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105641']
609,32282356,Corneal Haze After Transepithelial Collagen Cross-linking for Keratoconus: A Scheimpflug Densitometry Analysis.,"PURPOSE


To quantitate corneal haze and analyze the postoperative time course of corneal haze after transepithelial corneal collagen cross-linking (TECXL) in patients with keratoconus.
METHODS


Patients underwent TECXL and were randomized into 2 groups. One group received intraoperative riboflavin 0.10% every minute, and the second group received riboflavin 0.10% every 2 minutes during ultraviolet exposure. Scheimpflug densitometry was measured preoperatively, and at 1, 3, 6, and 12 months to assess the postoperative time course. Densitometry measurements were also correlated with visual acuity, pachymetry, and topography outcomes.
RESULTS


Fifty-nine eyes of 43 patients with keratoconus were analyzed. Preoperative mean corneal densitometry was 20.45 ± 2.79. Mean densitometry increased at 1 month (22.58 ± 3.79; P < 0.001), did not significantly change between 1 and 3 months (22.64 ± 3.83; P = 0.8), and significantly improved between 3 and 12 months postoperatively (mean6 21.59 ± 3.39; P = 0.002, mean12 20.80 ± 3.27; P = 0.002). There was no difference between preoperative and 1-year densitometry measurements (P = 0.21). There was no significant difference between the 1-minute and 2-minute subgroups. In addition, corneal densitometry at either 3 months or 1 year did not correlate with uncorrected distance visual acuity (P = 0.4), corrected distance visual acuity (P = 0.1), or maximum keratometry (P = 0.5), 1 year after corneal collagen cross-linking (CXL).
CONCLUSIONS


After TECXL, corneal haze increased slightly at 1 month, plateaued between 1 and 3 months, and returned to baseline between 3 and 12 months. In general, corneal haze in this study was substantially less than the haze previously reported for the standard cross-linking procedure. CXL-associated corneal haze did not correlate with the postoperative visual or topographic outcomes 1 year after CXL.",2020,"Mean densitometry increased at 1 month (22.58 ± 3.79; P < 0.001), did not significantly change between 1 and 3 months (22.64 ± 3.83; P = 0.8), and significantly improved between 3 and 12 months postoperatively (mean6 21.59 ± 3.39; P = 0.002, mean12 20.80 ± 3.27; P = 0.002).","['patients with keratoconus', 'Fifty-nine eyes of 43 patients with keratoconus', 'Patients underwent', 'Keratoconus']","['transepithelial corneal collagen cross-linking (TECXL', 'intraoperative riboflavin', 'riboflavin', 'TECXL']","['Corneal Haze', 'corneal haze', 'CXL-associated corneal haze', 'visual acuity, pachymetry, and topography outcomes', 'postoperative time course', 'corrected distance visual acuity', 'Mean densitometry', 'preoperative and 1-year densitometry measurements', 'uncorrected distance visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}]","[{'cui': 'C0010038', 'cui_str': 'Corneal opacity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011321', 'cui_str': 'Densitometry'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",43.0,0.0458156,"Mean densitometry increased at 1 month (22.58 ± 3.79; P < 0.001), did not significantly change between 1 and 3 months (22.64 ± 3.83; P = 0.8), and significantly improved between 3 and 12 months postoperatively (mean6 21.59 ± 3.39; P = 0.002, mean12 20.80 ± 3.27; P = 0.002).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Lai', 'Affiliation': 'The Cornea and Laser Eye Institute-Hersh Vision Group, CLEI Center for Keratoconus, Teaneck, NJ.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Greenstein', 'Affiliation': 'The Cornea and Laser Eye Institute-Hersh Vision Group, CLEI Center for Keratoconus, Teaneck, NJ.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Gelles', 'Affiliation': 'The Cornea and Laser Eye Institute-Hersh Vision Group, CLEI Center for Keratoconus, Teaneck, NJ.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Hersh', 'Affiliation': 'The Cornea and Laser Eye Institute-Hersh Vision Group, CLEI Center for Keratoconus, Teaneck, NJ.'}]",Cornea,['10.1097/ICO.0000000000002334']
610,32070125,What Guidewire Is the Best for Bypassing an Impacted Ureteral Stone?,"Introduction and Objectives:  To determine the optimal guidewire for bypassing an impacted ureteral stone.  Materials and Methods:  Three different benchtop models of varying impaction (300, 362, and 444 mm Hg pressure) were used to compare the ability of 13 different guidewires to bypass an impacted ureteral stone. In the first and second models, we recorded the maximum force required to bypass the stone. In the first model (300 mm Hg) 10 new wires for each of the 13 types were advanced past a ureteral stone using a series 5 digital force gauge. In the second model (362 mm Hg), the top 5 performing guidewires were similarly tested. In the third model (444 mm Hg), 5 attending urologists and 5 urology residents (blinded to wire type) compared the 13 guidewires and rated the wire performance using a Likert scale. Statistical analysis was performed with analysis of variance and the chi-square test.  Results:  In the first model, there was a significant difference between wires ( p  < 0.001) with the lowest mean force to bypass a stone seen in the Glidewire (0.117 ± 0.02 lbs) and HiWire (0.130 ± 0.01 lbs). Of the five wires tested in the second model, the Glidewire (0.24 ± 0.09 lbs) and UltraTrack (0.40 ± 0.35 lbs) both required less force than the other three wires ( p  = 0.018). In the third model, only two wires (Roadrunner and Glidewire) bypassed the impacted stone in 100% of trials. When comparing standard, hybrid, and hydrophilic wires, the hydrophilic had the highest success rate (standard = 0%, hybrid = 36.67%, and hydrophilic = 70.67%;  p  = 0.000) and Likert score (standard = 1.03, hybrid = 2.38, and hydrophilic = 3.24;  p  = 0.000). Hydrophilic wires required the least time to bypass the stone (hybrid = 82.81 seconds  vs  hydrophilic = 45.37 seconds,  p  = 0.000).  Conclusions:  In this benchtop study, standard wires performed poorly and hybrid wires were not as effective as hydrophilic wires. The Glidewire required the least force, the shortest insertion time, and had the highest surgeon satisfaction rating.",2020,"Hydrophilic wires required the least time to bypass the stone (hybrid:82.81 seconds vs. hydrophilic:45.37 seconds, p=0.000).
","['Three different benchtop models of varying impaction (300, 362, and 444 mmHg pressure']",[],"['highest success rate', 'Likert score']","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0333124', 'cui_str': 'Impaction (morphologic abnormality)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0327151,"Hydrophilic wires required the least time to bypass the stone (hybrid:82.81 seconds vs. hydrophilic:45.37 seconds, p=0.000).
","[{'ForeName': 'Akin S', 'Initials': 'AS', 'LastName': 'Amasyali', 'Affiliation': 'Department of Urology, Loma Linda University Health System, Loma Linda, California.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Groegler', 'Affiliation': 'Department of Urology, Loma Linda University Health System, Loma Linda, California.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hajiha', 'Affiliation': 'Department of Urology, Loma Linda University Health System, Loma Linda, California.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Department of Urology, Loma Linda University Health System, Loma Linda, California.'}, {'ForeName': 'Muhannad', 'Initials': 'M', 'LastName': 'Alsyouf', 'Affiliation': 'Department of Urology, Loma Linda University Health System, Loma Linda, California.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Stokes', 'Affiliation': 'Department of Urology, Loma Linda University Health System, Loma Linda, California.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Belay', 'Affiliation': 'Department of Urology, Loma Linda University Health System, Loma Linda, California.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Maldonado', 'Affiliation': 'Department of Urology, Loma Linda University Health System, Loma Linda, California.'}, {'ForeName': 'D Duane', 'Initials': 'DD', 'LastName': 'Baldwin', 'Affiliation': 'Department of Urology, Loma Linda University Health System, Loma Linda, California.'}]",Journal of endourology,['10.1089/end.2020.0058']
611,32281269,Comparison of Physical Therapy and Physician Pathways for Employees with Recent Onset Musculoskeletal Pain: A Randomized Controlled Trial.,"BACKGROUND


Life expectancy of the U.S. population will continue to rise, increasing the workforce demands in the treatment of musculoskeletal pathologies. With a declining primary care physician workforce, physical therapists (PT) may be in a unique situation to help absorb this demand.
OBJECTIVE


Our primary objective was to compare physical function between two primary care groups, a ""physical therapy-led pathway"" versus ""physician-led pathway"" in the management of recent-onset musculoskeletal pain at 1-month follow-up. Our secondary objectives were to compare other patient-important outcomes between the groups at 1 month and health utilization at 1 month and 1 year.
METHODS


A pragmatic randomized controlled trial with a 1-year follow-up was conducted, enrolling 150 university employees with recent onset musculoskeletal pain. Participants were randomized at first contact to either a PT-led pathway or physician-led pathway. The primary outcome was change in Patient-Reported Outcomes Measurement Information System (PROMIS) ShortForm v1-Physical Function 10a at 1 month; groups were compared with repeated measurement of analysis of variance and chi-square for both primary and secondary outcomes, except for satisfaction score at 1 month, which was cross-sectionally compared by independent two-sample t-test. At 1 year, healthcare utilization was assessed through medical record extraction, and healthcare utilization was converted to total episodic standard cost. Utilization was compared between groups using chi-square and Wilcoxon rank-sum tests.
RESULTS


Both groups demonstrated improvement at 1-month follow-up but showed no significant between-group difference in mean PROMIS scores at 1 month (PT-led pathway vs physician-led pathway, 2.04, [95% CI -0.28 to 4.36]; P = .082). At 1 year, there was no difference in healthcare utilization or cost between groups. No harm or misdiagnosis was found, filed, or reported by participants at 1 year.
CONCLUSION


This study shows equivalence in outcomes for two low-cost musculoskeletal care pathways with no risk of harm. These results reinforce other findings in the literature that support PTs as safe and effective initial providers for individuals with musculoskeletal disorders.",2020,"Both groups demonstrated improvement at 1-mo follow-up but showed no significant between-group difference in mean PROMIS scores at 1-mo (PT-led pathway vs physician-led pathway, 2.04, [95CI -0.28 to 4.36]; P = .0819).","['150 university employees with recent onset musculoskeletal pain', 'individuals with musculoskeletal disorders', 'For Employees With Recent Onset Musculoskeletal Pain']","['PT-led pathway or physician-led pathway', 'Physical Therapy And Physician Pathways', 'physical therapy-led pathway"" vs ""physician-led pathway']","['satisfaction score', 'No harm or misdiagnosis', 'change in PROMIS ShortForm v1-Physical Function', 'healthcare utilization or cost', 'mean PROMIS scores']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0679838', 'cui_str': 'Misdiagnosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",150.0,0.0950043,"Both groups demonstrated improvement at 1-mo follow-up but showed no significant between-group difference in mean PROMIS scores at 1-mo (PT-led pathway vs physician-led pathway, 2.04, [95CI -0.28 to 4.36]; P = .0819).","[{'ForeName': 'Heidi A', 'Initials': 'HA', 'LastName': 'Ojha', 'Affiliation': 'Physical Therapy Program, College of Public Health, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Fritz', 'Affiliation': 'College of Health, The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Alyson L', 'Initials': 'AL', 'LastName': 'Malitsky', 'Affiliation': 'Good Shepherd Penn Partners, Bala Cynwyd, PA, USA.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Epidemiology and Biostatistics, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Weiner', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medicine, NY, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Brandi', 'Affiliation': 'Moss Rehabilitation Hospital, Physical Therapy, Philadelphia, PA, USA.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Rhon', 'Affiliation': 'Doctoral Program in Physical Therapy, JBSA Fort Sam Houston, Baylor University, San Antonio, TX, USA.'}, {'ForeName': 'Ben H P', 'Initials': 'BHP', 'LastName': 'Mobo', 'Affiliation': 'Temple University, Temple Employee Health Service, Philadelphia, PA, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Fleming', 'Affiliation': 'Odyssey Physical Therapy, Philadelphia, PA, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Beidleman', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA, USA.'}, {'ForeName': 'W Geoffrey', 'Initials': 'WG', 'LastName': 'Wright', 'Affiliation': 'Physical Therapy Program, College of Public Health, Temple University, Philadelphia, PA, USA.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12382']
612,32282957,Effect of increased levothyroxine dose on depressive mood in older adults undergoing thyroid hormone replacement therapy.,"OBJECTIVE


Depressive mood consequent to hypothyroidism can be reversed with levothyroxine (LT4) replacement therapy. However, it is unclear whether increasing LT4 dose confers additional mood benefits.
DESIGN AND PATIENTS


A single-blinded before-and-after study of 24 patients with hypothyroidism who were aged 65 years or older and undergoing LT4 replacement therapy with stable doses.
MEASUREMENTS


Geriatric Depression Scale (GDS-K) and Hyperthyroid Symptom Scale (HSS-K) were assessed at baseline, 3 months after increasing LT4 dose by an additional 12.5 µg/d, and finally 3 months after returning to the baseline dose.
RESULTS


Serum thyroid-stimulating hormone (TSH) concentrations decreased at the higher LT4 dose (1.95 ± 2.16 vs 0.47 ± 1.09 mIU/L, P < .001) and recovered after returning to the baseline dose. Serum-free thyroxine levels and HSS-K scores were unchanged during the study period. GDS-K scores improved on the increased dose (9.5 ± 6.6 vs 7.5 ± 4.7, P = .029), and this improvement was maintained after returning to the baseline dose (9.5 ± 6.6 vs 7.4 ± 5.4, P = .010). Higher serum TSH was independently associated with both higher GDS-K and depression risk among those with depressive mood (GDS-K > 10) at baseline.
CONCLUSIONS


Depressive mood improves with increased LT4 dose, without significant hyperthyroid symptoms or signs, in older adults undergoing thyroid hormone replacement. These findings suggest the potential for varying the treatment target for hypothyroidism based on mood status and that low-dose LT4 treatment might be an ancillary treatment for depression.",2020,"Depressive mood improves with increased LT4 dose, without significant hyperthyroid symptoms or signs, in older adults undergoing thyroid hormone replacement.","['24 patients with hypothyroidism who were aged 65 years or older and undergoing LT4 replacement therapy with stable doses', 'older adults undergoing thyroid hormone replacement', 'older adults undergoing thyroid hormone replacement therapy']","['levothyroxine (LT4) replacement therapy', 'levothyroxine']","['Depressive mood', 'Higher serum TSH', 'GDS-K scores', 'Serum-free thyroxine levels and HSS-K scores', 'Geriatric Depression Scale (GDS-K) and Hyperthyroid Symptom Scale (HSS-K', 'depressive mood', 'Serum thyroid-stimulating hormone (TSH) concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C2242640', 'cui_str': 'Thyroid hormone replacement therapy'}]","[{'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0857986', 'cui_str': 'Serum thyroid stimulating hormone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1269634', 'cui_str': 'Serum free T4 measurement'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0020550', 'cui_str': 'Hyperthyroidism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",24.0,0.0602373,"Depressive mood improves with increased LT4 dose, without significant hyperthyroid symptoms or signs, in older adults undergoing thyroid hormone replacement.","[{'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Korea.'}, {'ForeName': 'Ji Won', 'Initials': 'JW', 'LastName': 'Han', 'Affiliation': 'Department of Neuropsychiatry, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Korea.'}, {'ForeName': 'Tae Jung', 'Initials': 'TJ', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Korea.'}, {'ForeName': 'Sung Hee', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Korea.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Korea.'}, {'ForeName': 'Ki Woong', 'Initials': 'KW', 'LastName': 'Kim', 'Affiliation': 'Department of Neuropsychiatry, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Korea.'}, {'ForeName': 'Hak Chul', 'Initials': 'HC', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Korea.'}]",Clinical endocrinology,['10.1111/cen.14189']
613,32281082,[The Effectiveness of a Mindfulness-Based Intervention in Reducing Relocation Anxiety and Promoting Adaptation in Older People With Diabetes].,"BACKGROUND


Relocating from home to a long-term facility is frequently a stressful event for older persons with diabetes. Therefore, it is important that nurses have available an intervention program that effectively reduces relocation anxiety and promotes adaptation in this population.
PURPOSE


To evaluate the effectiveness of a mindfulness-based intervention in reducing relocation anxiety and promoting adaptation in older persons with diabetes.
METHODS


Four long-term care facilities in Kaohsiung City were selected as the study sites. Residents of these facilities who had diabetes and who had moved in within the previous year were recruited as participants using a simple random-sampling method. The experimental group (n = 34) received a 9-week mindfulness-based intervention and the control group (n = 32) received routine diabetes care and maintained their normal daily routine. Outcome measurements included a demographic datasheet, the Taiwanese version of the State Anxiety Inventory, and the individual mental factors subscale of the elderly adaptation problem scale. These measures were administered at baseline and upon completion of the intervention.
RESULTS


Thirty participants in each group completed the study. The mean differences between the baseline and post-test scores in the experimental group for relocation anxiety (t = 5.15, p < .01) and adaptation (t = -5.57, p < .01) were both significant. Among the participants who tested positive for relocation anxiety at pretest (a mean score > 30.13; 83.3% of the participants), those in the experimental group reported a more significant decrease (p < .05) in relocation anxiety at posttest than their control group peers. Among the participants who tested as having poor adaptation pretest (a mean scores < 45.62; 71.7% of the participants), those in the experimental group reported a more significant improvement (p < .05) in adaptation at posttest than their control group peers.
CONCLUSIONS / IMPLICATIONS FOR PRACTICE


The results indicate that the 9-week intervention has the potential to help older people with diabetes improve their relocation anxiety and adaptation. This study may be used as a reference to improve emotional distress among residents of long-term care facilities.",2020,"The mean differences between the baseline and post-test scores in the experimental group for relocation anxiety (t = 5.15, p < .01) and adaptation (t = -5.57, p < .01) were both significant.","['Older People With Diabetes', 'Four long-term care facilities in Kaohsiung City were selected as the study sites', 'Residents of these facilities who had diabetes and who had moved in within the previous year were recruited as participants using a simple random-sampling method', 'older persons with diabetes', 'older people with diabetes', 'residents of long-term care facilities', 'Thirty participants in each group completed the study']","['9-week mindfulness-based intervention and the control group', 'routine diabetes care and maintained their normal daily routine', 'mindfulness-based intervention', 'Mindfulness-Based Intervention']","['demographic datasheet, the Taiwanese version of the State Anxiety Inventory, and the individual mental factors subscale of the elderly adaptation problem scale', 'Relocation Anxiety', 'relocation anxiety', 'emotional distress']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449370', 'cui_str': 'Method of sampling'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",,0.015058,"The mean differences between the baseline and post-test scores in the experimental group for relocation anxiety (t = 5.15, p < .01) and adaptation (t = -5.57, p < .01) were both significant.","[{'ForeName': 'Pei-Chen', 'Initials': 'PC', 'LastName': 'Tsai', 'Affiliation': 'MSN, RN, Lecturer, Department of Nursing, Fooyin University, Taiwan, ROC.'}, {'ForeName': 'Shu-Ming', 'Initials': 'SM', 'LastName': 'Chen', 'Affiliation': 'PhD, RN, Assistant Professor, Department of Nursing, Fooyin University, Taiwan, ROC. ft036@fy.edu.tw.'}, {'ForeName': 'Huey-Shyan', 'Initials': 'HS', 'LastName': 'Lin', 'Affiliation': 'PhD, Professor, Department of Health-Business Administration, Fooyin University, Taiwan, ROC.'}, {'ForeName': 'Ying-Ju', 'Initials': 'YJ', 'LastName': 'Chen', 'Affiliation': 'Student, Department of Nursing, Fooyin University, Taiwan, ROC.'}]",Hu li za zhi The journal of nursing,['10.6224/JN.202004_67(2).07']
614,32281095,Investigation of a New Catheter on Relieving Pain During Male Cystoscopy - A Randomized Clinical Trial.,"PURPOSE


To investigate the pain intensity and tolerability of a new catheter applied to urethral surface anesthesia during rigid cystoscopy in male patients, and explore the prospects of its application and the anesthetic method in hospitals at primary levels.
MATERIALS AND METHODS


252 adult male patients were randomly divided into the experimental group and the control group.1% lidocaine solution was irrigated into the posterior urethra of the experimental group using the new catheter before cystoscopy, while the control group was administered with lidocaine gel. Both groups were assessed by visual analogue scale(VAS) with their pain perceived during administration of lidocaine (control group) /during insertion of catheter and administration of lidocaine (experimental group) (T1),during the insertion of cystoscope (T2),at the beginning of cystoscopy (T3),The third minute of cystoscopy (T4), during the first urination after the procedure (T5), as well with the maximum pain(Pmax) perceived during the whole procedure. The fluctuations of blood pressure and heart rate in each group before, after and during the procedure were recorded, and the anesthesia costs in both groups were calculated.
RESULTS


Except a slightly higher score in T1, the scores of VAS in experimental group were lower than those of control group in T2,T3 and T4. The Pmax of the control group was 4.92(SD=1.20), which was higher than in the experimental group of 3.89(SD=0.95,P<0.01).There was no significant difference on blood pressure variation in both groups. While heart rate variation in experimental group was lower than that in control group (16.3%,SD=3.4 vs. 22.6%,SD=5.0, P<0.01).No obvious complications were found in both groups. The anesthesia cost of the experimental group is about 1.53 dollars, with 1.75 dollars lower than that of the control group.
CONCLUSION


It is tolerable and beneficial to apply the new catheter for male urethral anesthesia. It can significantly relieve the pain during rigid cystoscopy in male patients, and is low in cost and easy in operation. Thus this method is worth being recommended to hospitals, especially at community hospitals or primary hospitals.",2020,"While heart rate variation in experimental group was lower than that in control group (16.3%,SD=3.4 vs. 22.6%,SD=5.0, P<0.01).No obvious complications were found in both groups.","['252 adult male patients', 'male urethral anesthesia', 'male patients']","['New Catheter', 'control group.1% lidocaine solution', 'lidocaine gel', 'new catheter applied to urethral surface anesthesia during rigid cystoscopy', 'lidocaine (control group) /during insertion of catheter and administration of lidocaine (experimental group']","['scores of VAS', 'heart rate variation', 'anesthesia costs', 'pain intensity and tolerability', 'pain', 'anesthesia cost', 'fluctuations of blood pressure and heart rate', 'blood pressure variation', 'Relieving Pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0577993', 'cui_str': 'Rigid cystoscopy'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",252.0,0.0267797,"While heart rate variation in experimental group was lower than that in control group (16.3%,SD=3.4 vs. 22.6%,SD=5.0, P<0.01).No obvious complications were found in both groups.","[{'ForeName': 'Xiong Yong', 'Initials': 'XY', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology,YongChuan Hospital of ChongQing medical university,Xuan Hua Road,Yongchuan District, ChongQing,402160,China. xiongyongjiang1988@126.com.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Jiaji', 'Affiliation': 'Department of Urology,YongChuan Hospital of ChongQing medical university,Xuan Hua Road,Yongchuan District, ChongQing,402160,China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Tao', 'Affiliation': 'Department of Urology,YongChuan Hospital of ChongQing medical university,Xuan Hua Road,Yongchuan District, ChongQing,402160,China.'}]",Urology journal,['10.22037/uj.v0i0.5130']
615,32199790,Pregnancy intentions and contraceptive uptake after miscarriage.,"OBJECTIVE


To identify factors associated with contraceptive uptake among participants in a miscarriage management clinical trial.
STUDY DESIGN


We performed a secondary analysis of a multi-center, randomized controlled trial of medical management regimens for miscarriage between 5 and 12 completed weeks. Pregnancy intention was measured by patient report after miscarriage diagnosis. Participants were offered contraception in accordance with standard clinical care once their miscarriage was completed. We analyzed participants as a cohort and fit a multivariable model to describe demographic characteristics and pregnancy intentions independently associated with contraceptive uptake.
RESULTS


Of 244 participants with available contraceptive outcomes, 121 (50%) stated that this pregnancy was planned, and 218 (90%) stated that they had planned to continue the pregnancy to term. Ninety-seven participants (40%) initiated contraception: 33 (14%) selected a long-acting reversible method, 44 (18%) a short-acting reversible method, and 20 (8%) condoms or emergency contraception, while 147 (60%) declined contraception after miscarriage completion. In the multivariable model, unplanned pregnancy (aRR 2.13, 95% CI: 1.45-3.13) and lack of intention to continue the pregnancy (aRR 1.61, 95% CI: 1.18-2.20) were independently associated with contraceptive uptake. Of participants who declined contraception, 85 (57%) did so in order to conceive again. Nearly one-quarter of participants who declined contraception described the index pregnancy as unplanned, but after miscarriage planned to conceive a new pregnancy.
CONCLUSION


Patients with unplanned pregnancy who miscarried were twice as likely to initiate contraception as those with planned pregnancy, however pregnancy intentions sometimes changed after miscarriage.
IMPLICATIONS


Miscarriage management represents an important opportunity to clarify pregnancy goals and provide contraceptive counseling. Although unplanned pregnancy correlates with contraceptive uptake, we do not recommend using this clinically to predict contraceptive need. Future research should examine how best to measure pregnancy intention and its relationship to the experience of miscarriage.",2020,"In the multivariable model, unplanned pregnancy (aRR 2.13, 95% CI: 1.45-3.13) and lack of intention to continue the pregnancy (aRR 1.61, 95% CI: 1.18-2.20) were independently associated with contraceptive uptake.","['244 participants with available contraceptive outcomes, 121 (50', 'Ninety-seven participants (40%) initiated contraception: 33 (14%) selected a long-acting reversible method, 44 (18%) a short-acting reversible method, and 20 (8%) condoms or emergency contraception, while 147 (60%) declined contraception after miscarriage completion', 'participants in a miscarriage management clinical trial', 'Of participants who declined contraception, 85 (57%) did so in order to conceive again', 'miscarriage between 5 and 12 completed weeks']",[],"['Pregnancy intention', 'unplanned pregnancy', 'Pregnancy intentions and contraceptive uptake']","[{'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0558252', 'cui_str': 'Emergency Contraception'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",[],"[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0041747', 'cui_str': 'Unintended Pregnancy'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}]",244.0,0.114047,"In the multivariable model, unplanned pregnancy (aRR 2.13, 95% CI: 1.45-3.13) and lack of intention to continue the pregnancy (aRR 1.61, 95% CI: 1.18-2.20) were independently associated with contraceptive uptake.","[{'ForeName': 'Andrea H', 'Initials': 'AH', 'LastName': 'Roe', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce St., Philadelphia, PA 19104, United States. Electronic address: andrea.roe@uphs.upenn.edu.'}, {'ForeName': 'Arden', 'Initials': 'A', 'LastName': 'McAllister', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce St., Philadelphia, PA 19104, United States.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado, 13001 E. 17th Place, B119, Bldg 500, 3rd Floor West Wing, Aurora, CO 80045, United States.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce St., Philadelphia, PA 19104, United States.'}]",Contraception,['10.1016/j.contraception.2020.03.002']
616,31285038,Effectiveness of a cognitive behavioural intervention for patients with undifferentiated somatoform disorder: Results from the CIPRUS cluster randomized controlled trial in primary care.,"OBJECTIVE


To examine the effectiveness of a cognitive behavioural intervention delivered by mental health nurse practitioners (MHNPs) to patients with undifferentiated somatoform disorder (USD), compared to usual care.
METHODS


We conducted a cluster randomized trial among primary care patients with USD comparing the intervention to usual care. The intervention consisted of six sessions with the MHNP. Primary outcome was physical functioning (RAND-36 physical component summary score). Secondary outcomes were the RAND-36 mental component summary score and the eight subscales; anxiety and depression (Hospital Anxiety and Depression Scale) and somatic symptom severity (Patient Health Questionnaire-15). Outcomes were assessed at baseline, 2, 4 and 12 months. We analysed data using linear mixed models by intention-to-treat, and investigated effect modifiers.
RESULTS


Compared to usual care (n = 87), the intervention group (n = 111) showed an improvement in physical functioning (mean difference 2.24 [95% CI 0.51; 3.97]; p = .011), a decrease in limitations due to physical problems (mean difference 10.82 [95% CI 2.14; 19.49]; p. = 0.015) and in pain (mean difference 5.08 [95% CI 0.58; 9.57]; p = .027), over 12 months. However effect sizes were small and less clinically relevant than expected. We found no differences for anxiety, depression and somatic symptom severity. Effects were larger and clinically relevant for patients with more recent symptoms and fewer physical diseases.
CONCLUSION


The cognitive behavioural intervention was effective in improving pain and physical functioning components of patients' health. It was particularly suitable for patients with symptoms that had been present for a limited number of years and with few comorbid physical diseases.
TRIAL REGISTRATION


The trial is registered in the Dutch Trial Registry, www.trialregister.nl, under NTR4686.",2019,"Compared to usual care (n = 87), the intervention group (n = 111) showed an improvement in physical functioning (mean difference 2.24 [95% CI 0.51; 3.97]; p = .011), a decrease in limitations due to physical problems (mean difference 10.82 [95% CI 2.14; 19.49];","['patients with undifferentiated somatoform disorder', 'primary care patients with USD comparing the intervention to usual care', 'patients with undifferentiated somatoform disorder (USD', 'patients with symptoms that had been present for a limited number of years and with few comorbid physical diseases']","['cognitive behavioural intervention', 'cognitive behavioural intervention delivered by mental health nurse practitioners (MHNPs', 'MHNP']","['pain and physical functioning components', 'pain', 'anxiety, depression and somatic symptom severity', 'RAND-36 mental component summary score and the eight subscales; anxiety and depression (Hospital Anxiety and Depression Scale) and somatic symptom severity (Patient Health Questionnaire-15', 'physical functioning', 'physical functioning (RAND-36 physical component summary score', 'limitations due to physical problems']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041672', 'cui_str': 'Undifferentiated somatoform disorder (disorder)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1964024', 'cui_str': 'Mental health nurse (occupation)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3839861', 'cui_str': 'Medically Unexplained Symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",,0.159452,"Compared to usual care (n = 87), the intervention group (n = 111) showed an improvement in physical functioning (mean difference 2.24 [95% CI 0.51; 3.97]; p = .011), a decrease in limitations due to physical problems (mean difference 10.82 [95% CI 2.14; 19.49];","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sitnikova', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, De Boelelaan 1117, Amsterdam, Netherlands. Electronic address: e.sitnikova@vumc.nl.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Leone', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'Harm W J', 'Initials': 'HWJ', 'LastName': 'van Marwijk', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Twisk', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'Henriëtte E', 'Initials': 'HE', 'LastName': 'van der Horst', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, De Boelelaan 1117, Amsterdam, Netherlands.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2019.109745']
617,31743165,Methylprednisolone Does Not Reduce Acute Postoperative Pain After Cardiac Surgery: Subanalysis of a Randomized Clinical Trial.,"BACKGROUND


Pain after cardiac surgery is largely treated with opioids, but their poor safety profile makes nonopioid medications attractive as part of multimodal pathways. Anti-inflammatory drugs reduce acute postoperative pain, but the role of steroids in reducing acute poststernotomy pain is unclear. We evaluated the association between the intraoperative administration of methylprednisolone and postoperative analgesia, defined as a composite of pain scores and opioid consumption, during the initial 24 hours after cardiac surgery.
METHODS


We conducted a post hoc retrospective analysis of a large clinical trial in which adults having cardiac surgery were randomized 1:1 to receive 2 intraoperative doses of 250 mg IV methylprednisolone or placebo. Pain scores and opioid consumption were collected during the initial 24 hours after surgery. Methylprednisolone was considered to be associated with better pain control than placebo if proven noninferior (not worse) on both pain scores (defined a priori with delta of 1 point) and opioid consumption (delta of 20%) and superior to placebo in at least 1 of the 2 outcomes. This test was repeated in the opposite direction (testing whether placebo is better than methylprednisolone on postoperative pain management).
RESULTS


Of 251 eligible patients, 127 received methylprednisolone and 124 received placebo. Methylprednisolone was noninferior to placebo on pain with difference in mean (CI) pain scores of -0.25 (-0.71 to 0.21); P < .001. However, methylprednisolone was not noninferior to placebo on opioid consumption (ratio of geometric means [CI]: 1.11 [0.64-1.91]; P = .37). Because methylprednisolone was not noninferior to placebo on both outcomes, we did not proceed to superiority testing based on the a priori stopping rules. Similar results were found when testing the opposite direction.
CONCLUSIONS


In this post hoc analysis, we could not identify a beneficial analgesic effect after cardiac surgery associated with methylprednisolone administration. There are currently no data to suggest that methylprednisolone has significant analgesic benefit in adults having cardiac surgery.",2019,"In this post hoc analysis, we could not identify a beneficial analgesic effect after cardiac surgery associated with methylprednisolone administration.","['adults having cardiac surgery', '251 eligible patients']","['placebo', 'methylprednisolone or placebo', 'Methylprednisolone', 'methylprednisolone']","['pain scores', 'opioid consumption', 'pain control', 'Acute Postoperative Pain', 'Pain scores and opioid consumption', 'mean (CI) pain scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",251.0,0.683031,"In this post hoc analysis, we could not identify a beneficial analgesic effect after cardiac surgery associated with methylprednisolone administration.","[{'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Whitlock', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Essber', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Azfar', 'Initials': 'A', 'LastName': 'Niazi', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Makarova', 'Affiliation': ''}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Saasouh', 'Affiliation': ''}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Alfirevic', 'Affiliation': 'Department of Cardiothoracic Anesthesia Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Donn', 'Initials': 'D', 'LastName': 'Marciniak', 'Affiliation': 'Department of Cardiothoracic Anesthesia Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'From the Departments of Outcomes Research.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004061']
618,31743169,Dexmedetomidine for Improved Quality of Emergence From General Anesthesia: A Dose-Finding Study.,"BACKGROUND


Dexmedetomidine provides smooth and hemodynamically stable emergence at the expense of hypotension, delayed recovery, and sedation. We investigated the optimal dose of dexmedetomidine for prevention of cough, agitation, hypertension, tachycardia, and shivering, with minimal side effects.
METHODS


In this prospective, randomized, double-blind trial, 216 adult patients were randomly assigned to dexmedetomidine 1 µg/kg (D 1), 0.5 µg/kg (D 0.5), 0.25 µg/kg (D 0.25), or control (C). During emergence, cough, agitation, hemodynamic parameters, shivering, time to extubation, and sedation scores were recorded.
RESULTS


A total of 190 patients were analyzed. The respective incidences for the groups D 1, D 0.5, and D 0.25 versus group C were 48%, 64%, and 64% vs 84% for cough-corrected P < .003 between groups D 1 and C; 33%, 34%, and 33% vs 72% for agitation-corrected P < .003 between group C and each of the study groups; and 4%, 2%, and 7% vs 22% for shivering-corrected P = .03 and corrected P = .009 between groups D 1 and D 0.5 versus group C, respectively. The percent increase from baseline blood pressure on extubation for the 3 treatment groups was significantly lower than group C. Percent increase in heart rate was lower than control in groups D 1 and D 0.5 but not in group D 0.25. Time to extubation and sedation scores were comparable. However, more hypotension was recorded during the emergence phase in the 3 treatment groups versus group C.
CONCLUSIONS


D 1 at the end of surgery provides the best quality of emergence from general anesthesia including the control of cough, agitation, hypertension, tachycardia, and shivering. D 0.5 also controls emergence phenomena but is less effective in controlling cough. The 3 doses do not delay extubation. However, they cause dose-dependent hypotension.",2019,The percent increase from baseline blood pressure on extubation for the 3 treatment groups was significantly lower than group C. Percent increase in heart rate was lower than control in groups D 1 and D 0.5 but not in group D 0.25.,"['Emergence From General Anesthesia', '216 adult patients', 'A total of 190 patients were analyzed']","['dexmedetomidine', 'Dexmedetomidine']","['cough, agitation, hypertension, tachycardia, and shivering', 'baseline blood pressure on extubation', 'hypotension', 'Time to extubation and sedation scores', 'heart rate', 'cough, agitation, hemodynamic parameters, shivering, time to extubation, and sedation scores']","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",216.0,0.0898928,The percent increase from baseline blood pressure on extubation for the 3 treatment groups was significantly lower than group C. Percent increase in heart rate was lower than control in groups D 1 and D 0.5 but not in group D 0.25.,"[{'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Aouad', 'Affiliation': 'From the Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Zeeni', 'Affiliation': 'From the Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Rony', 'Initials': 'R', 'LastName': 'Al Nawwar', 'Affiliation': 'From the Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Sahar M', 'Initials': 'SM', 'LastName': 'Siddik-Sayyid', 'Affiliation': 'From the Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Hanane B', 'Initials': 'HB', 'LastName': 'Barakat', 'Affiliation': 'Department of Anesthesiology, Lebanese American University Medical Center-Rizk Hospital, Beirut, Lebanon.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Elias', 'Affiliation': 'From the Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Vanda G', 'Initials': 'VG', 'LastName': 'Yazbeck Karam', 'Affiliation': 'Department of Anesthesiology, Lebanese American University Medical Center-Rizk Hospital, Beirut, Lebanon.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000002763']
619,31743170,Comparison of Intraoperative Sedation With Dexmedetomidine Versus Propofol on Acute Postoperative Pain in Total Knee Arthroplasty Under Spinal Anesthesia: A Randomized Trial.,"BACKGROUND


In patients undergoing total knee arthroplasty under spinal anesthesia, we compared the postoperative analgesic effect of intraoperative sedation with dexmedetomidine versus propofol. We hypothesized that sedation with dexmedetomidine would result in lower postoperative opioid analgesic consumption than with propofol.
METHODS


Forty-eight patients were enrolled and randomly assigned to either a dexmedetomidine group (n = 24), which received a loading dose of 1 μg/kg dexmedetomidine over 10 minutes, followed by a continuous infusion of 0.1-0.5 μg·kg·hour, or a propofol group (n = 24), which received a continuous infusion of propofol via a target-controlled infusion to maintain the effect-site concentration within a range of 0.5-2.0 μg/mL. The drug infusion rate was determined according to the sedation level, targeting a modified observer's assessment of alertness/sedation score of 3 or 4. The cumulative amounts of fentanyl administered via intravenous patient-controlled analgesia were recorded at 24 and 48 hours postoperatively (primary outcome). The postoperative numerical rating scale for pain was assessed at 6, 12, 24, and 48 hours (secondary outcome). The postoperative use of additional rescue analgesic (ketoprofen) and antiemetic drugs was also compared between the 2 groups at 24 and 48 hours.
RESULTS


Dexmedetomidine significantly reduced postoperative fentanyl consumption (median [interquartile range]) during 0-24 hours (45 [30-71] vs 150 [49-248] μg, P = .004; median difference = -105 μg [99.98% CI, 210-7.5]), 24-48 hours (90 [45-143] vs 188 [75-266] μg, P = .005; median difference = -98 μg [99.98% CI, 195-45]), and 0-48 hours (135 [68-195] vs 360 [146-480] μg, P = .003; median difference = -225 μg [99.98% CI, 405-7.5]). The numerical rating scale (median [interquartile range]) was lower at 6 hours (1 [0-2] vs 2 [1-3], P = .003), 12 hours (1 [1-2] vs 3 [2-3], P < .001), 24 hours (1 [1-2] vs 3 [2-3], P < .001), and 48 hours (2 [2-3] vs 3 [3-4], P < .001) after surgery in the dexmedetomidine group compared to the propofol group. No significant intergroup differences were observed in the amount of rescue analgesics and antiemetics at 24 hours (P = .155 and P = .482) and 48 hours (P = .082 and P = .153) after surgery.
CONCLUSIONS


Intraoperative dexmedetomidine sedation was associated with a small but clinically important reduction in postoperative opioid use after total knee arthroplasty.",2019,"No significant intergroup differences were observed in the amount of rescue analgesics and antiemetics at 24 hours (P = .155 and P = .482) and 48 hours (P = .082 and P = .153) after surgery.
","['patients undergoing total knee arthroplasty under spinal anesthesia', 'Forty-eight patients', 'Total Knee Arthroplasty', '225 μg']","['dexmedetomidine versus propofol', 'dexmedetomidine', 'analgesic (ketoprofen', 'dexmedetomidine sedation', 'Dexmedetomidine', 'Intraoperative Sedation', 'Dexmedetomidine Versus Propofol', 'propofol']","['cumulative amounts of fentanyl administered via intravenous patient-controlled analgesia', 'amount of rescue analgesics and antiemetics', 'Acute Postoperative Pain', 'postoperative fentanyl consumption', 'postoperative numerical rating scale for pain', 'postoperative opioid analgesic consumption', 'numerical rating scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain (finding)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'Analgesics, Opioid'}]",48.0,0.512177,"No significant intergroup differences were observed in the amount of rescue analgesics and antiemetics at 24 hours (P = .155 and P = .482) and 48 hours (P = .082 and P = .153) after surgery.
","[{'ForeName': 'Hyun-Jung', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Sang-Hwan', 'Initials': 'SH', 'LastName': 'Do', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Jae-Sung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Tae-Kyun', 'Initials': 'TK', 'LastName': 'Kim', 'Affiliation': 'Joint Reconstruction Center, Department of Orthopedic Surgery, Seoul National University Bundang Hospital, Seongnam-si, South Korea.'}, {'ForeName': 'Hyo-Seok', 'Initials': 'HS', 'LastName': 'Na', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003315']
620,31743175,Targeted Use of Alcohol-Based Hand Rub on Gloves During Task Dense Periods: One Step Closer to Pathogen Containment by Anesthesia Providers in the Operating Room.,"BACKGROUND


Anesthesia providers' hand hygiene practices in the operating room may contribute to the transmission of bacteria. There is a debate, however, over the best approaches for pathogen containment during task dense periods (induction and extubation) of anesthesia care. A novel approach to reducing pathogen spread during these task dense periods is the use of alcohol-based hand rub on gloves when it may be difficult to either change gloves or clean hands.
METHODS


To evaluate the impact of alcohol-based hand rub on gloves, we estimated perforation rates of 50 gloves that were worn as pairs by volunteers for 2 hours at a time applying alcohol-based hand rub every 15 minutes (total of 8 alcohol-based hand rub applications per pair of gloves). We also identified perforation rates of 50 new, unused gloves. To evaluate the ability to perform routine anesthesia functions, volunteers were asked to pick up a coin from a table top and document whether the gloves felt normal or sticky at each 15-minute period.
RESULTS


Fifty new gloves (not exposed to alcohol-based hand rub) were tested for integrity using the Food and Drug Administration-approved process, and one was found to have a microperforation. Of the 50 gloves that had been applied with alcohol-based hand rub 8 times, no microperforations were identified. All volunteers demonstrated tactile competence by picking up a coin from a table top after 8 alcohol-based hand rub applications; in addition, as the number of alcohol-based hand rub applications progressed, the volunteers reported increased stickiness.
CONCLUSIONS


This study suggests that the use of alcohol-based hand rub on commonly used nitrile examination gloves does not compromise glove integrity or hamper the ability to safely perform routine anesthesia functions.",2019,"Of the 50 gloves that had been applied with alcohol-based hand rub 8 times, no microperforations were identified.",['Fifty new gloves (not exposed to alcohol-based hand rub'],"['alcohol-based hand rub', 'Alcohol-Based Hand Rub on Gloves']",['tactile competence'],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0206069', 'cui_str': 'Glove'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0177773,"Of the 50 gloves that had been applied with alcohol-based hand rub 8 times, no microperforations were identified.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Birnbach', 'Affiliation': 'From the Department of Anesthesiology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Taylor C', 'Initials': 'TC', 'LastName': 'Thiesen', 'Affiliation': 'From the Department of Anesthesiology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Nathan T', 'Initials': 'NT', 'LastName': 'McKenty', 'Affiliation': 'From the Department of Anesthesiology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Lisa F', 'Initials': 'LF', 'LastName': 'Rosen', 'Affiliation': 'University of Miami-Jackson Memorial Hospital Center for Patient Safety, Miami, Florida.'}, {'ForeName': 'Kristopher L', 'Initials': 'KL', 'LastName': 'Arheart', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Fitzpatrick', 'Affiliation': 'University of Miami-Jackson Memorial Hospital Center for Patient Safety, Miami, Florida.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Everett-Thomas', 'Affiliation': 'University of Miami School of Nursing and Health Studies, Miami, Florida.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004107']
621,31499231,Effects of a comprehensive self-management intervention on extraintestinal symptoms among patients with IBS.,"OBJECTIVE


Adults with irritable bowel syndrome (IBS) often report extraintestinal pain, fatigue, and sleep disturbances in addition to abdominal pain. Few interventions have sought to reduce these extraintestinal symptoms within the IBS population. To address this, we compared the effects of a comprehensive self-management (CSM) intervention to a control intervention (usual care) on extraintestinal pain, fatigue, and sleep disturbances among patients with IBS.
METHOD


Data were obtained from 243 IBS patients participating in two CSM intervention trials. Daily symptom diaries were collected at baseline, 3 and 6 months post-randomization. Daily symptoms of headache, backache, muscle pain, joint pain, fatigue, sleepiness during the day, sleep quality, and refreshed by sleep were analyzed. Analysis of covariance was used to determine the effects of the intervention on each symptom at 3 and 6 months controlling for 'study' and baseline symptom levels.
RESULTS


Patients in the CSM intervention group reported decreased symptoms of fatigue, sleep disturbances, backache and headache compared to usual care at 3 and 6 months. The CSM group also reported significantly decreased joint pain at 3 months compared to usual care, but not 6 months. No significant difference was found for muscle pain.
CONCLUSIONS


An existing CSM intervention is effective in reducing fatigue and sleep disturbances. However, mixed results for extraintestinal pain indicates a need to better differentiate between underlying mechanisms. Addressing such symptoms is important to decrease the overall burden of IBS, reduce health care expenditures, and improve patients' quality of life.
TRIAL REGISTRATION


NCT00907790; NCT00167635.",2019,"RESULTS


Patients in the CSM intervention group reported decreased symptoms of fatigue, sleep disturbances, backache and headache compared to usual care at 3 and 6 months.","['patients with IBS', 'Adults with irritable bowel syndrome (IBS', '243 IBS patients participating in two CSM intervention trials']","['comprehensive self-management (CSM) intervention', 'comprehensive self-management intervention', 'control intervention (usual care', 'CSM intervention']","['Daily symptom diaries', 'joint pain', 'fatigue and sleep disturbances', 'extraintestinal pain, fatigue, and sleep disturbances', 'muscle pain', 'Daily symptoms of headache, backache, muscle pain, joint pain, fatigue, sleepiness during the day, sleep quality, and refreshed by sleep', 'extraintestinal symptoms', 'symptoms of fatigue, sleep disturbances, backache and headache']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",243.0,0.0367462,"RESULTS


Patients in the CSM intervention group reported decreased symptoms of fatigue, sleep disturbances, backache and headache compared to usual care at 3 and 6 months.","[{'ForeName': 'Kendra J', 'Initials': 'KJ', 'LastName': 'Kamp', 'Affiliation': 'University of Washington, United States of America. Electronic address: kamp@uw.edu.'}, {'ForeName': 'Kristen R', 'Initials': 'KR', 'LastName': 'Weaver', 'Affiliation': 'University of Maryland, United States of America. Electronic address: kristen.weaver@umaryland.edu.'}, {'ForeName': 'LeeAnne B', 'Initials': 'LB', 'LastName': 'Sherwin', 'Affiliation': 'University of Missouri, United States of America. Electronic address: sherwinl@missouri.edu.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Barney', 'Affiliation': 'University of Washington, United States of America. Electronic address: pamb@uw.edu.'}, {'ForeName': 'Sun-Kyung', 'Initials': 'SK', 'LastName': 'Hwang', 'Affiliation': 'Pusan National University, South Korea. Electronic address: skhwang@uw.edu.'}, {'ForeName': 'Pei-Lin', 'Initials': 'PL', 'LastName': 'Yang', 'Affiliation': 'University of Washington, United States of America. Electronic address: plinyang@uw.edu.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Burr', 'Affiliation': 'University of Washington, United States of America. Electronic address: bobburr@uw.edu.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Cain', 'Affiliation': 'University of Washington, United States of America. Electronic address: cain@uw.edu.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Heitkemper', 'Affiliation': 'University of Washington, United States of America. Electronic address: heit@uw.edu.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2019.109821']
622,31707107,Neurofeedback impacts cognition and quality of life in pediatric focal epilepsy: An exploratory randomized double-blinded sham-controlled trial.,"OBJECTIVE


Children with epilepsy experience cognitive deficits and well-being issues that have detrimental effects on their development. Pharmacotherapy is the standard of care in epilepsy; however, few interventions exist to promote cognitive development and to mitigate disease burden. We aimed to examine the impact of two different modalities of neurofeedback (NFB) on cognitive functioning and quality-of-life (QOL) measurements in children and adolescents with controlled focal epilepsy. The study also explored the effects of NFB on clinical outcomes and electroencephalography (EEG) quantitative analysis.
METHODS


Participants (n = 44) with controlled focal epilepsy were randomized to one of three arms: sensorimotor rhythm (SMR) NFB (n = 15), slow cortical potentials (SCP) NFB (n = 16), or sham NFB (n = 13). All participants received 25 sessions of intervention. The attention switching task (AST), Liverpool Seizure Severity Scale (LSSS), seizure frequency (SF), EEG power spectrum, and coherence were measured at baseline, postintervention, and at 3-month follow-up.
RESULTS


In children and adolescents with controlled focal epilepsy, SMR training significantly reduced reaction time in the AST (p = 0.006), and this was correlated with the difference of change for theta power on EEG (p = 0.03); only the SMR group showed a significant decrease in beta coherence (p = 0.03). All groups exhibited improvement in QOL (p = <0.05).
CONCLUSIONS


This study provides the first data on two NFB modalities (SMR and SCP) including cognitive, neurophysiological, and clinical outcomes in pediatric epilepsy. Sensorimotor rhythm NFB improved cognitive functioning, while all the interventions showed improvements in QOL, demonstrating a powerful placebo effect in the sham group.",2019,"All groups exhibited improvement in QOL (p = <0.05).
","['pediatric focal epilepsy', 'Participants (n\u202f=\u202f44) with controlled focal epilepsy', 'Children with epilepsy experience cognitive deficits', 'pediatric epilepsy', 'children and adolescents with controlled focal epilepsy']","['neurofeedback (NFB', 'Pharmacotherapy', 'NFB modalities (SMR and SCP', 'NFB', 'sensorimotor rhythm (SMR) NFB (n\u202f=\u202f15), slow cortical potentials (SCP) NFB (n\u202f=\u202f16), or sham NFB']","['reaction time', 'clinical outcomes and electroencephalography (EEG) quantitative analysis', 'Neurofeedback impacts cognition and quality of life', 'cognitive functioning', 'beta coherence', 'QOL', 'cognitive functioning and quality-of-life (QOL) measurements', 'attention switching task (AST), Liverpool Seizure Severity Scale (LSSS), seizure frequency (SF), EEG power spectrum, and coherence']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0014547', 'cui_str': 'Focal Seizure Disorder'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034380'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.331688,"All groups exhibited improvement in QOL (p = <0.05).
","[{'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Morales-Quezada', 'Affiliation': 'Neuromodulation Center, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Charlestown, MA, USA. Electronic address: jmorales-quezada@partners.org.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Martinez', 'Affiliation': 'Boston Neurodynamics, Brookline, MA, USA; Neocemod, Centro de Neuromodulacion, Aguascalientes, Mexico.'}, {'ForeName': 'Mirret M', 'Initials': 'MM', 'LastName': 'El-Hagrassy', 'Affiliation': 'Neuromodulation Center, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies and Therapeutic Encounter, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'M Barry', 'Initials': 'MB', 'LastName': 'Sterman', 'Affiliation': 'Department of Neurobiology, UCLA School of Medicine, USA; Department of Biobehavioral Psychiatry, UCLA School of Medicine, USA.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': ""Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Osher Center for Integrative Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.106570']
623,31702883,A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus.,"BACKGROUND


Difelikefalin is a peripherally restricted and selective agonist of kappa opioid receptors that are considered to be important in modulating pruritus in conditions such as chronic kidney disease.
METHODS


In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients undergoing hemodialysis who had moderate-to-severe pruritus to receive either intravenous difelikefalin (at a dose of 0.5 μg per kilogram of body weight) or placebo three times per week for 12 weeks. The primary outcome was the percentage of patients with an improvement (decrease) of at least 3 points from baseline at week 12 in the weekly mean score on the 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS; scores range from 0 to 10, with higher scores indicating greater itch intensity). The secondary outcomes included the change from baseline in itch-related quality-of-life measures, the percentage of patients with an improvement of at least 4 points in the WI-NRS score at week 12, and safety.
RESULTS


A total of 378 patients underwent randomization. A total of 82 of 158 patients (51.9%) in the difelikefalin group had a decrease of at least 3 points in the WI-NRS score (primary outcome), as compared with 51 of 165 (30.9%) in the placebo group. The imputed percentage of patients with a decrease of at least 3 points in the WI-NRS score was 49.1% in the difelikefalin group, as compared with 27.9% in the placebo group (P<0.001). Difelikefalin also resulted in a significant improvement from baseline to week 12 in itch-related quality of life as measured by the 5-D itch scale and the Skindex-10 scale. The imputed percentage of patients with a decrease of at least 4 points in the WI-NRS score at week 12 was significantly greater in the difelikefalin group than in the placebo group (37.1% [observed data: 64 of 158 patients] vs. 17.9% [observed data: 35 of 165 patients], P<0.001). Diarrhea, dizziness, and vomiting were more common in the difelikefalin group than in the placebo group.
CONCLUSIONS


Patients treated with difelikefalin had a significant reduction in itch intensity and improved itch-related quality of life as compared with those who received placebo. (Funded by Cara Therapeutics; KALM-1 ClinicalTrials.gov number, NCT03422653.).",2020,"Diarrhea, dizziness, and vomiting were more common in the difelikefalin group than in the placebo group.
","['Hemodialysis Patients with Pruritus', 'patients undergoing hemodialysis who had moderate-to-severe pruritus to receive either', '378 patients underwent randomization']","['placebo', 'intravenous difelikefalin', 'Difelikefalin', 'difelikefalin']","['Diarrhea, dizziness, and vomiting', 'itch-related quality of life', 'WI-NRS score', '24-hour Worst Itching Intensity Numerical Rating Scale', 'itch intensity and improved itch-related quality of life', 'change from baseline in itch-related quality-of-life measures, the percentage of patients with an improvement of at least 4 points in the WI-NRS score at week 12, and safety']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0222045'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",378.0,0.341431,"Diarrhea, dizziness, and vomiting were more common in the difelikefalin group than in the placebo group.
","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fishbane', 'Affiliation': 'From the Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (S.F.); North America Research Institute, San Dimas, CA (A.J.); and Cara Therapeutics, Stamford, CT (C.M., W.W., F.M.).'}, {'ForeName': 'Aamir', 'Initials': 'A', 'LastName': 'Jamal', 'Affiliation': 'From the Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (S.F.); North America Research Institute, San Dimas, CA (A.J.); and Cara Therapeutics, Stamford, CT (C.M., W.W., F.M.).'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Munera', 'Affiliation': 'From the Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (S.F.); North America Research Institute, San Dimas, CA (A.J.); and Cara Therapeutics, Stamford, CT (C.M., W.W., F.M.).'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Wen', 'Affiliation': 'From the Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (S.F.); North America Research Institute, San Dimas, CA (A.J.); and Cara Therapeutics, Stamford, CT (C.M., W.W., F.M.).'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Menzaghi', 'Affiliation': 'From the Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (S.F.); North America Research Institute, San Dimas, CA (A.J.); and Cara Therapeutics, Stamford, CT (C.M., W.W., F.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1912770']
624,31734556,Mediation analysis shows that a decline in self-efficacy mediates the increase in fatigue severity following an initial positive response to cognitive behavioural therapy in Q fever fatigue syndrome.,"OBJECTIVE


Q fever fatigue syndrome (QFS) is characterized by chronic fatigue following acute Q fever. Previously, it was shown that cognitive behavioural therapy (CBT), and not doxycycline, was significantly more effective than placebo in reducing fatigue severity in QFS patients. However, this effect was not maintained after one year. The aim of this study is to elucidate the cognitive and behavioural variables which mediate the positive effect of CBT on fatigue during the treatment and the relapse of fatigue after completion of CBT, by using multiple mediation analysis.
METHODS


Additional analyses were performed on data of a randomized controlled trial that investigated the efficacy of CBT and antibiotics compared to placebo for QFS [1]. Only those patients in the CBT group who completed the allocated CBT treatment, and those patients in the medication group who did not follow additional CBT during follow-up, were included in this study. Two mediation models were tested, using respectively assessments at baseline and end-of-treatment (EOT), and EOT and follow-up, comparing the CBT group (n = 43) with the medication group (n = 89).
RESULTS


During treatment, the decrease in fatigue brought on by CBT was completely mediated by an increase in self-efficacy with respect to fatigue. A reduction in self-efficacy partly mediated the increase in fatigue at follow-up in the CBT group.
CONCLUSIONS


Given the decline in self efficacy, booster sessions focussing on restoration and maintenance of self-efficacy with respect to fatigue, may lead to elongation of the initial positive effects of CBT for QFS.",2019,"During treatment, the decrease in fatigue brought on by CBT was completely mediated by an increase in self-efficacy with respect to fatigue.",['QFS patients'],"['cognitive behavioural therapy (CBT', 'CBT', 'doxycycline', 'CBT and antibiotics', 'placebo']","['self-efficacy', 'fatigue severity', 'fatigue brought', 'fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0670181,"During treatment, the decrease in fatigue brought on by CBT was completely mediated by an increase in self-efficacy with respect to fatigue.","[{'ForeName': 'Evi M C', 'Initials': 'EMC', 'LastName': 'Breukers', 'Affiliation': 'Radboud Expert Centre for Q Fever, Radboud university medical center Nijmegen, the Netherlands. Electronic address: evibreukers@gmail.com.'}, {'ForeName': 'Ruud P H', 'Initials': 'RPH', 'LastName': 'Raijmakers', 'Affiliation': 'Radboud Expert Centre for Q Fever, Radboud university medical center Nijmegen, the Netherlands; Department of Internal Medicine, Division of Infectious Diseases, Radboud university medical center Nijmegen, the Netherlands. Electronic address: Ruud.Raijmakers@radboudumc.nl.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Nieuwkerk', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, Amsterdam Public Health Research Institute, University of Amsterdam, the Netherlands. Electronic address: P.T.Nieuwkerk@amsterdamumc.nl.'}, {'ForeName': 'Gijs', 'Initials': 'G', 'LastName': 'Bleijenberg', 'Affiliation': 'Radboud Expert Centre for Q Fever, Radboud university medical center Nijmegen, the Netherlands. Electronic address: Gijs.Bleijenberg@radboudumc.nl.'}, {'ForeName': 'Jos W M', 'Initials': 'JWM', 'LastName': 'van der Meer', 'Affiliation': 'Radboud Expert Centre for Q Fever, Radboud university medical center Nijmegen, the Netherlands; Department of Internal Medicine, Division of Infectious Diseases, Radboud university medical center Nijmegen, the Netherlands. Electronic address: Jos.vanderMeer@radboudumc.nl.'}, {'ForeName': 'Chantal P', 'Initials': 'CP', 'LastName': 'Bleeker-Rovers', 'Affiliation': 'Radboud Expert Centre for Q Fever, Radboud university medical center Nijmegen, the Netherlands; Department of Internal Medicine, Division of Infectious Diseases, Radboud university medical center Nijmegen, the Netherlands. Electronic address: Chantal.Bleeker-Rovers@radboudumc.nl.'}, {'ForeName': 'Stephan P', 'Initials': 'SP', 'LastName': 'Keijmel', 'Affiliation': 'Radboud Expert Centre for Q Fever, Radboud university medical center Nijmegen, the Netherlands; Department of Internal Medicine, Division of Infectious Diseases, Radboud university medical center Nijmegen, the Netherlands. Electronic address: Stephan.Keijmel@radboudumc.nl.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Knoop', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, Amsterdam Public Health Research Institute, University of Amsterdam, the Netherlands; Expert Centre for Chronic Fatigue, Department of Medical Psychology, Amsterdam University Medical Centers, VU University, Amsterdam, the Netherlands. Electronic address: Hans.Knoop@amsterdamumc.nl.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2019.109841']
625,31743177,Global and Regional Respiratory Mechanics During Robotic-Assisted Laparoscopic Surgery: A Randomized Study.,"BACKGROUND


Pneumoperitoneum and nonphysiological positioning required for robotic surgery increase cardiopulmonary risk because of the use of larger airway pressures (Paws) to maintain tidal volume (VT). However, the quantitative partitioning of respiratory mechanics and transpulmonary pressure (PL) during robotic surgery is not well described. We tested the following hypothesis: (1) the components of driving pressure (transpulmonary and chest wall components) increase in a parallel fashion at robotic surgical stages (Trendelenburg and robot docking); and (2) deep, when compared to routine (moderate), neuromuscular blockade modifies those changes in PLs as well as in regional respiratory mechanics.
METHODS


We studied 35 American Society of Anesthesiologists (ASA) I-II patients undergoing elective robotic surgery. Airway and esophageal balloon pressures and respiratory flows were measured to calculate respiratory mechanics. Regional lung aeration and ventilation was assessed with electrical impedance tomography and level of neuromuscular blockade with acceleromyography. During robotic surgical stages, 2 crossover randomized groups (conditions) of neuromuscular relaxation were studied: Moderate (1 twitch in the train-of-four stimulation) and Deep (1-2 twitches in the posttetanic count).
RESULTS


Pneumoperitoneum was associated with increases in driving pressure, tidal changes in PL, and esophageal pressure (Pes). Steep Trendelenburg position during robot docking was associated with further worsening of the respiratory mechanics. The fraction of driving pressures that partitioned to the lungs decreased from baseline (63% ± 15%) to Trendelenburg position (49% ± 14%, P < .001), due to a larger increase in chest wall elastance (Ecw; 12.7 ± 7.6 cm H2O·L) than in lung elastance (EL; 4.3 ± 5.0 cm H2O·L, P < .001). Consequently, from baseline to Trendelenburg, the component of Paw affecting the chest wall increased by 6.6 ± 3.1 cm H2O, while PLs increased by only 3.4 ± 3.1 cm H2O (P < .001). PL and driving pressures were larger at surgery end than at baseline and were accompanied by dorsal aeration loss. Deep neuromuscular blockade did not change respiratory mechanics, regional aeration and ventilation, and hemodynamics.
CONCLUSIONS


In robotic surgery with pneumoperitoneum, changes in ventilatory driving pressures during Trendelenburg and robot docking are distributed less to the lungs than to the chest wall as compared to routine mechanical ventilation for supine patients. This effect of robotic surgery derives from substantially larger increases in Ecw than ELs and reduces the risk of excessive PLs. Deep neuromuscular blockade does not meaningfully change global or regional lung mechanics.",2019,"RESULTS


Pneumoperitoneum was associated with increases in driving pressure, tidal changes in PL, and esophageal pressure (Pes).",['35 American Society of Anesthesiologists (ASA) I-II patients undergoing'],"['robotic surgery with pneumoperitoneum', 'Global and Regional Respiratory Mechanics During Robotic-Assisted Laparoscopic Surgery', 'robotic surgery', 'acceleromyography', 'elective robotic surgery']","['Paw affecting the chest wall', 'fraction of driving pressures', 'quantitative partitioning of respiratory mechanics and transpulmonary pressure (PL', 'Regional lung aeration and ventilation', 'driving pressure, tidal changes in PL, and esophageal pressure (Pes', 'chest wall elastance', 'ventilatory driving pressures', 'Airway and esophageal balloon pressures and respiratory flows', 'PL and driving pressures', 'change respiratory mechanics, regional aeration and ventilation, and hemodynamics']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C3805242', 'cui_str': 'Acceleromyography'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205076', 'cui_str': 'Chest Wall'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure (observable entity)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0179752', 'cui_str': 'Esophageal balloon, device (physical object)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",35.0,0.0702256,"RESULTS


Pneumoperitoneum was associated with increases in driving pressure, tidal changes in PL, and esophageal pressure (Pes).","[{'ForeName': 'Julio C', 'Initials': 'JC', 'LastName': 'Brandão', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Marcos A', 'Initials': 'MA', 'LastName': 'Lessa', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Motta-Ribeiro', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Soshi', 'Initials': 'S', 'LastName': 'Hashimoto', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Luis Felipe', 'Initials': 'LF', 'LastName': 'Paula', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Torsani', 'Affiliation': 'Cardio-Pulmonary Department, Pulmonary Division, Heart Institute (Incor), University of São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Linh', 'Initials': 'L', 'LastName': 'Le', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Bao', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Eikermann', 'Affiliation': 'Department of Urology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Dahl', 'Affiliation': 'Department of Urology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Tabatabaei', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Marcelo B P', 'Initials': 'MBP', 'LastName': 'Amato', 'Affiliation': 'Cardio-Pulmonary Department, Pulmonary Division, Heart Institute (Incor), University of São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Marcos F', 'Initials': 'MF', 'LastName': 'Vidal Melo', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004289']
626,32283870,The Effects of Low-Nickel Diet Combined with Oral Administration of Selected Probiotics on Patients with Systemic Nickel Allergy Syndrome (SNAS) and Gut Dysbiosis.,"BACKGROUND


Nickel (Ni) oral consumption may elicit systemic reactions in patients affected by systemic nickel allergy syndrome (SNAS), including gastrointestinal symptoms, which in turn are associated with gut dysbiosis. We evaluated the effects of a low-Ni diet alone or in combination with the oral consumption of appropriate probiotics on Ni-sensitivity and urinary dysbiosis markers in SNAS patients.
METHODS


n  = 51 patients with SNAS and concomitant intestinal dysbiosis were enrolled in the study. According to the urinary indican/skatole levels, quantified through a colorimetric and a high-performance liquid chromatographic method, respectively, patients were assigned to a dysbiosis type/grade and followed a low-Ni diet for three months. Along with the diet, 22 patients also consumed probiotics based on the dysbiosis type. In particular, a Lactobacilli- or Bifidobacteria-containing formulation was administered to patients with fermentative or putrefactive dysbiosis, respectively, while a broad-spectrum probiotic formulation containing both Lactobacilli and Bifidobacteria was administered to patients with mixed dysbiosis. After three months, patients were invited to repeat the Ni-stimulation and the dysbiosis tests.
RESULTS


The fermentative dysbiosis group represented the largest group followed by the mixed dysbiosis group, while only two patients had putrefactive dysbiosis. Overall, at three months of treatment in general (diet alone with or without probiotics), the Ni-sensitivity and dysbiosis levels were strongly ameliorated. The association of a low-Ni diet with a specific probiotic oral supplementation was significantly more effective in decreasing dysbiosis levels or reaching eubiosis than with diet alone.
CONCLUSION


Our results, while confirming the benefits of a low-Ni diet in SNAS patients, strongly support that appropriate adjuvant treatment with probiotics significantly helps to improve intestinal dysbiosis or restore a healthy microbiota.",2020,"The association of a low-Ni diet with a specific probiotic oral supplementation was significantly more effective in decreasing dysbiosis levels or reaching eubiosis than with diet alone.
","['Patients with Systemic Nickel Allergy Syndrome (SNAS) and Gut Dysbiosis', 'SNAS patients', 'n  = 51 patients with SNAS and concomitant intestinal dysbiosis were enrolled in the study', 'patients affected by systemic nickel allergy syndrome (SNAS']","['Low-Nickel Diet Combined with Oral Administration of Selected Probiotics', 'Nickel (Ni) oral consumption', 'general (diet alone with or without probiotics']","['Ni-sensitivity and urinary dysbiosis markers', 'dysbiosis levels', 'Ni-sensitivity and dysbiosis levels', 'intestinal dysbiosis or restore a healthy microbiota']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0028013', 'cui_str': 'nickel'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C3658208', 'cui_str': 'Dysbiosis'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C4287543', 'cui_str': 'Intestinal dysbiosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}]","[{'cui': 'C0452363', 'cui_str': 'Low nickel diet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0028013', 'cui_str': 'nickel'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0684345', 'cui_str': 'Contact dermatitis due to nickel'}, {'cui': 'C3658208', 'cui_str': 'Dysbiosis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4287543', 'cui_str': 'Intestinal dysbiosis'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",51.0,0.0211122,"The association of a low-Ni diet with a specific probiotic oral supplementation was significantly more effective in decreasing dysbiosis levels or reaching eubiosis than with diet alone.
","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Lombardi', 'Affiliation': ""Department of Life, Health & Environmental Sciences, University of L'Aquila, Via Pompeo Spennati, Building Rita Levi Montalcini, Coppito, 67100 L'Aquila, Italy.""}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Fiasca', 'Affiliation': ""Department of Life, Health & Environmental Sciences, University of L'Aquila, Via Pompeo Spennati, Building Rita Levi Montalcini, Coppito, 67100 L'Aquila, Italy.""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Minelli', 'Affiliation': 'PoliSmail, Specialistic Unit Allergic & Immunological Pathologies, Via Clemente Rebora, 1, 73100 Lecce, Italy.'}, {'ForeName': 'Dominga', 'Initials': 'D', 'LastName': 'Maio', 'Affiliation': 'PoliSmail, Specialistic Unit Allergic & Immunological Pathologies, Via Clemente Rebora, 1, 73100 Lecce, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Mattei', 'Affiliation': ""Department of Life, Health & Environmental Sciences, University of L'Aquila, Via Pompeo Spennati, Building Rita Levi Montalcini, Coppito, 67100 L'Aquila, Italy.""}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Vergallo', 'Affiliation': 'PoliSmail, Specialistic Unit Allergic & Immunological Pathologies, Via Clemente Rebora, 1, 73100 Lecce, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Cifone', 'Affiliation': ""Department of Life, Health & Environmental Sciences, University of L'Aquila, Via Pompeo Spennati, Building Rita Levi Montalcini, Coppito, 67100 L'Aquila, Italy.""}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Cinque', 'Affiliation': ""Department of Life, Health & Environmental Sciences, University of L'Aquila, Via Pompeo Spennati, Building Rita Levi Montalcini, Coppito, 67100 L'Aquila, Italy.""}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Minelli', 'Affiliation': 'PoliSmail, Specialistic Unit Allergic & Immunological Pathologies, Via Clemente Rebora, 1, 73100 Lecce, Italy.'}]",Nutrients,['10.3390/nu12041040']
627,32276370,NIV Is not Adequate for High Intensity Endurance Exercise in COPD.,"Noninvasive ventilation (NIV) during exercise has been suggested to sustain higher training intensity but the type of NIV interface, patient-ventilator asynchronies (PVA) or technological limitation of the ventilator may interfere with exercise. We assessed whether these parameters affect endurance exercise capacity in severe COPD patients. In total, 21 patients with severe COPD not eligible to home NIV performed three constant workload tests. The first test was carried out on spontaneous breathing (SB) and the following ones with NIV and a nasal or oronasal mask in a randomized order. PVA and indicators of ventilator performance were assessed through a comprehensive analysis of the flow pressure tracing raw data from the ventilator. The time limit was significantly reduced with both masks (406 s (197-666), 240 s (131-385) and 189 s (115-545),  p  < 0.01 for tests in SB, with oronasal and nasal mask, respectively). There were few PVA with an oronasal mask (median: 3.4% (1.7-5.2)) but the ventilator reached its maximal generating capacity (median flowmax: 208.0 L/s (189.5-224.8) while inspiratory pressure dropped throughout exercise (from 10.1 (9.4-11.4) to 8.8 cmH2O (8.6-10.8),  p  < 0.01). PVA were more frequent with nasal mask (median: 12.8% (3.2-31.6),  p  < 0.01). Particularly, the proportion of patients with ineffective efforts > 10% was significantly higher with nasal interface (0% versus 33.3%,  p  < 0.01). NIV did not effectively improve endurance capacity in COPD patients not acclimated to home NIV. This was due to a technological limitation of the ventilator for the oronasal mask and the consequence either of an insufficient pressure support or a technological limitation for the nasal mask.",2020,"PVA were more frequent with nasal mask (median: 12.8% (3.2-31.6),  p  < 0.01).","['21 patients with severe COPD not eligible to home', 'severe COPD patients']",['Noninvasive ventilation (NIV'],"['endurance capacity', 'spontaneous breathing (SB', 'PVA and indicators of ventilator performance', 'endurance exercise capacity', 'time limit', 'nasal interface', 'PVA', 'inspiratory pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0032623', 'cui_str': 'Polyvinyl Alcohol'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0332186', 'cui_str': 'Definite time'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",21.0,0.0357313,"PVA were more frequent with nasal mask (median: 12.8% (3.2-31.6),  p  < 0.01).","[{'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Bonnevie', 'Affiliation': 'Normandie University, UNIROUEN, UPRES EA 3830, Rouen university hospital, Haute Normandie Research and Biomedical Innovation, 76000 Rouen, France.'}, {'ForeName': 'Francis-Edouard', 'Initials': 'FE', 'LastName': 'Gravier', 'Affiliation': 'Normandie University, UNIROUEN, UPRES EA 3830, Rouen university hospital, Haute Normandie Research and Biomedical Innovation, 76000 Rouen, France.'}, {'ForeName': 'Emeline', 'Initials': 'E', 'LastName': 'Fresnel', 'Affiliation': 'KerNel Biomedical, 76000 Rouen, France.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Kerfourn', 'Affiliation': 'KerNel Biomedical, 76000 Rouen, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Medrinal', 'Affiliation': 'Normandie University, UNIROUEN, UPRES EA 3830, Rouen university hospital, Haute Normandie Research and Biomedical Innovation, 76000 Rouen, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Prieur', 'Affiliation': 'Normandie University, UNIROUEN, UPRES EA 3830, Rouen university hospital, Haute Normandie Research and Biomedical Innovation, 76000 Rouen, France.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Combret', 'Affiliation': 'Institute of Experimental and Clinical Research (IREC), Pole of Pulmonology, ORL and Dermatology, Catholic University of Louvain, 1000 Brussels, Belgium.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Muir', 'Affiliation': 'Normandie University, UNIROUEN, UPRES EA 3830, Rouen university hospital, Haute Normandie Research and Biomedical Innovation, 76000 Rouen, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Cuvelier', 'Affiliation': 'Normandie University, UNIROUEN, UPRES EA 3830, Rouen university hospital, Haute Normandie Research and Biomedical Innovation, 76000 Rouen, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Debeaumont', 'Affiliation': 'Department of Respiratory and Exercise Physiology and CIC-CRB 1404, Rouen University Hospital, 76000 Rouen, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Pneumology Department, Saint-Luc University Clinics, 1000 Brussels, Belgium.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Patout', 'Affiliation': 'Normandie University, UNIROUEN, UPRES EA 3830, Rouen university hospital, Haute Normandie Research and Biomedical Innovation, 76000 Rouen, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Viacroze', 'Affiliation': 'Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, 76000 Rouen, France.'}]",Journal of clinical medicine,['10.3390/jcm9041054']
628,32276375,"Effects of Cocoa Butter and Cocoa Butter Equivalent in a Chocolate Confectionery on Human Blood Triglycerides, Glucose and Insulin.","Given the rising trend in the consumption of chocolate confectioneries, the shortage in cocoa butter (CB) production remains a constant threat to food manufacturers. Therefore, exploring alternative plant sources of CB is essential. Sal fat, obtained from seed kernels of trees, has the potential to substitute CB in chocolate confectioneries. The primary aims of this randomised controlled, crossover trial was to compare the glycaemic, insulinaemic and lipidaemic response of two different oil types (CB and Sal fat) in people and the effects of these oils in two physical forms (liquid and oleogel). Seventeen healthy male participants (age 24.73 ± 2.63, height 173.81 ± 7.24 cm, weight 65.85 ± 8.06 kg, BMI 21.73 ± 1.65 kg/m 2 ) completed the study. There were no significant differences in blood glucose iAUC ( p  = 0.995), plasma insulin ( p  = 0.760) and triglyceride (TG) ( p  = 0.129), regardless of oil type consumed. When comparing incremental area under the curve (iAUC) of insulin and TG between the different forms (liquid or oleogel), oleogel was found to be significantly lower ( p  = 0.014 and  p  = 0.024 respectively). Different types of oil transformed into oleogels are effective in reducing postprandial insulinaemia and lipidaemia. Sal fat, although not metabolically different from CB, can be an acceptable substitute for CB in the production of chocolate confectioneries.",2020,"There were no significant differences in blood glucose iAUC ( p  = 0.995), plasma insulin ( p  = 0.760) and triglyceride (TG) ( p  = 0.129), regardless of oil type consumed.","['Seventeen healthy male participants (age 24.73 ± 2.63, height 173.81 ± 7.24 cm, weight 65.85 ± 8.06 kg, BMI 21.73 ± 1.65 kg/m 2 ) completed the study']","['Cocoa Butter and Cocoa Butter Equivalent', 'oil types (CB and Sal fat']","['Human Blood Triglycerides, Glucose and Insulin', 'triglyceride (TG', 'plasma insulin', 'glycaemic, insulinaemic and lipidaemic response', 'blood glucose iAUC', 'postprandial insulinaemia and lipidaemia']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0056057', 'cui_str': 'cocoa butter'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0518018', 'cui_str': 'Blood triglycerides'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}]",17.0,0.0533234,"There were no significant differences in blood glucose iAUC ( p  = 0.995), plasma insulin ( p  = 0.760) and triglyceride (TG) ( p  = 0.129), regardless of oil type consumed.","[{'ForeName': 'Rina Yu Chin', 'Initials': 'RYC', 'LastName': 'Quek', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR) and National University Health System, 14 Medical Drive, Singapore 117599, Singapore.'}, {'ForeName': 'Elaine Wan Yi', 'Initials': 'EWY', 'LastName': 'Peh', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR) and National University Health System, 14 Medical Drive, Singapore 117599, Singapore.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR) and National University Health System, 14 Medical Drive, Singapore 117599, Singapore.'}]","Foods (Basel, Switzerland)",['10.3390/foods9040455']
629,32276315,"High Variability in Erythrocyte, Plasma and Whole Blood EPA and DHA Levels in Response to Supplementation.","(1) Aim: the aim of this secondary analysis was to report the variability in response to  n -3 long chain polyunsaturated fatty acids (LCPUFA) supplementation in erythrocytes, plasma and whole blood of a previously published dose response study. (2) Methods: a randomized, double-blind, placebo-controlled trial of parallel design was conducted, whereby pre-menopausal women were randomly assigned to consume 0, 0.35, 0.7 or 1 g/day of supplemental eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA). Fasted blood samples were taken at baseline and after eight weeks intervention. Erythrocyte, plasma and whole blood fatty acids were extracted using the method of Lepage and Roy and analysed using gas chromatography. (3) Results: There were significant increases in EPA plus DHA levels in the 0.7 g and 1 g dose groups, with the highest increase with the 1 g dose notably: in erythrocytes (from 5.69% to 7.59%), plasma (from 2.94% to 5.48%) and in whole blood (from 3.81% to 6.03%). There was high variability in response to the supplement in erythrocytes, plasma and whole blood across the different doses. (4) Conclusion: there is high individual variability in  n -3 LCPUFA levels in response to  n -3 LCPUFA supplementation, which should be taken into account in clinical trials using  n -3 LCPUFA supplements.",2020,"There was high variability in response to the supplement in erythrocytes, plasma and whole blood across the different doses.",['whereby pre-menopausal women'],"['n -3 long chain polyunsaturated fatty acids (LCPUFA) supplementation', 'supplemental eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA', 'placebo']","['EPA plus DHA levels', 'plasma', 'erythrocytes', 'Erythrocyte, plasma and whole blood fatty acids', 'High Variability in Erythrocyte, Plasma and Whole Blood EPA and DHA Levels']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.203004,"There was high variability in response to the supplement in erythrocytes, plasma and whole blood across the different doses.","[{'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Sparkes', 'Affiliation': 'School of Medicine, Molecular Horizons, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Faculty of Health, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Gibson', 'Affiliation': 'University of Adelaide, Adelaide, SA 5005, Australia.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Else', 'Affiliation': 'School of Medicine, Molecular Horizons, University of Wollongong, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'School of Medicine, Molecular Horizons, University of Wollongong, Wollongong, NSW 2522, Australia.'}]",Nutrients,['10.3390/nu12041017']
630,32279227,Efficacy of Postbiotics in a PRP-Like Cosmetic Product for the Treatment of Alopecia Area Celsi: A Randomized Double-Blinded Parallel-Group Study.,"INTRODUCTION


Alopecia areata (AA), also known as 'area Celsi', is the second most common form of hair loss affecting the scalp. Newly proposed treatments for AA include low-level light therapy, biologics such as Janus kinase inhibitors and autologous platelet-rich plasma (PRP), which is a well-known ""elixir"" for hair growth. Bioactive peptides developed through biotechnological applications have been used to overcome the limitations of PRP. More recently, the involvement of microbiota in hair growth disorders, in AA in particular, has been reported, and the usefulness of microbial metabolites, i.e. postbiotics, has been suggested.
METHODS


This study was a randomized double-blinded parallel-group study in which 160 persons of both sexes affected by AA and aged between 18 and 60 years were enrolled. The subjects were randomly assigned to a treatment group (group 1), receiving the TR-PRP plus-Celsi cosmetic product, and a placebo group (group 2). The SALT (Severity of Alopecia Tool) score was determined in both groups at baseline and after 2 and 3 months of treatment, and the results compared between groups.
RESULTS


The subjects in group 1 showed a significant change from baseline in SALT score at 2 months of treatment (61.04% ± 3.45%; p < 0.0001), with a further improvement at the end of treatment (3 months) (69.56% ± 4.32%; p < 0.0001). No significant changes from baseline were reported for the subjects in group 2 (T1: 26.45% ± 3.64%; T3: 27.63% ± 7.61%).
CONCLUSIONS


The results of this study provide further proof of the efficacy of bioactive peptides that mimick the growth factors present in PRP in subjects affected by AA. They also add to our knowledge of the link between microbiota and hair growth disorders, emphasizing the importance of studies on the microbial community and microbial metabolites as a novel therapeutic approach.",2020,"No significant changes from baseline were reported for the subjects in group 2 (T1: 26.45% ± 3.64%; T3: 27.63% ± 7.61%).
","['Alopecia Area Celsi', '160 persons of both sexes affected by AA and aged between 18 and 60\xa0years were enrolled']","['Postbiotics', 'PRP-Like Cosmetic Product', 'TR-PRP plus-Celsi cosmetic product, and a placebo']","['SALT (Severity of Alopecia Tool) score', 'SALT score']","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.108524,"No significant changes from baseline were reported for the subjects in group 2 (T1: 26.45% ± 3.64%; T3: 27.63% ± 7.61%).
","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Rinaldi', 'Affiliation': 'Human Advanced Microbiome Project (HMAP), Giuliani SpA, Milan, Italy. fabio.rinaldi@studiorinaldi.com.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Trink', 'Affiliation': 'Human Advanced Microbiome Project (HMAP), Giuliani SpA, Milan, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pinto', 'Affiliation': 'Human Advanced Microbiome Project (HMAP), Giuliani SpA, Milan, Italy.'}]",Dermatology and therapy,['10.1007/s13555-020-00369-9']
631,32278779,"Association of Guideline-Recommended COPD Inhaler Regimens With Mortality, Respiratory Exacerbations, and Quality of Life: A Secondary Analysis of the Long-Term Oxygen Treatment Trial.","BACKGROUND


Although inhaled therapy reduces exacerbations among patients with COPD, the effectiveness of providing inhaled treatment per risk stratification models remains unclear.
RESEARCH QUESTION


Are inhaled regimens that align with the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy associated with clinically important outcomes?
STUDY DESIGN AND METHODS


We conducted secondary analyses of Long-term Oxygen Treatment Trial (LOTT) data. The trial enrolled patients with COPD with moderate resting or exertional hypoxemia between 2009 and 2015. Our exposure was the patient-reported inhaled regimen at enrollment, categorized as either aligning with, undertreating, or potentially overtreating per the 2017 GOLD strategy. Our primary composite outcome was time to death or first hospitalization for COPD. Additional outcomes included individual components of the composite outcome and time to first exacerbation. We generated multivariable Cox proportional hazard models across strata of GOLD-predicted exacerbation risk (high vs low) to estimate between-group hazard ratios for time to event outcomes. We adjusted models a priori for potential confounders, clustered by site.
RESULTS


The trial enrolled 738 patients (73.4% men; mean age, 68.8 years). Of the patients, 571 (77.4%) were low risk for future exacerbations. Of the patients, 233 (31.6%) reported regimens aligning with GOLD recommendations; most regimens (54.1%) potentially overtreated. During a 2.3-year median follow-up, 332 patients (44.9%) experienced the composite outcome. We found no difference in time to composite outcome or death among patients reporting regimens aligning with recommendations compared with undertreated patients. Among patients at low risk, potential overtreatment was associated with higher exacerbation risk (hazard ratio, 1.42; 95% CI, 1.09-1.87), whereas inhaled corticosteroid treatment was associated with 64% higher risk of pneumonia (incidence rate ratio, 1.64; 95% CI, 1.01-2.66).
INTERPRETATION


Among patients with COPD with moderate hypoxemia, we found no difference in clinical outcomes between inhaled regimens aligning with the 2017 GOLD strategy compared with those that were undertreated. These findings suggest the need to reevaluate the effectiveness of risk stratification model-based inhaled treatment strategies.",2020,We found no difference in time-to composite outcome or death among patients reporting regimens aligning with recommendations compared to undertreated patients.,"['COPD patients with moderate hypoxemia', 'enrolled COPD patients with moderate resting or exertional hypoxemia between 2009-2015', 'and Methods', 'COPD patients', '571 patients (77.4%) were low-risk for future exacerbations', '738 patients; 73.4% were male with mean age 68.8 years']",[],"['individual components of the composite outcome and time-to first exacerbation', 'exacerbation risk', 'COPD Inhaler Regimenswith Mortality, Respiratory Exacerbations, and Quality of Life', 'risk of pneumonia', 'time-to composite outcome or death', 'time-to death or first hospitalization for COPD']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",738.0,0.234867,We found no difference in time-to composite outcome or death among patients reporting regimens aligning with recommendations compared to undertreated patients.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA. Electronic address: tlk33@uw.edu.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Spece', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Donovan', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Edmunds', 'Initials': 'E', 'LastName': 'Udris', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Coggeshall', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffith', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Bryant', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'J Allen', 'Initials': 'JA', 'LastName': 'Cooper', 'Affiliation': 'Birmingham VA Medical Center and the Lung Health Center, University of Alabama Birmingham, Birmingham, AL.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Temple University School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Phillip T', 'Initials': 'PT', 'LastName': 'Diaz', 'Affiliation': '201 Heart Lung Institute, Ohio State University School of Medicine, Columbus, OH.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Fuhlbrigge', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Gay', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor, MI.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Kanner', 'Affiliation': 'University of Utah Health Sciences Center, Salt Lake City, UT.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Panos', 'Affiliation': 'Cincinnati VA Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shade', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sternberg', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stibolt', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Stoller', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Yusen', 'Affiliation': 'Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Feemster', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}]",Chest,['10.1016/j.chest.2020.02.073']
632,32278781,"Effect of Venlafaxine on Apnea-Hypopnea Index in Patients With Sleep Apnea: A Randomized, Double-Blind Crossover Study.","BACKGROUND


One of the key mechanisms underlying OSA is reduced pharyngeal muscle tone during sleep. Data suggest that pharmacologic augmentation of central serotonergic/adrenergic tone increases pharyngeal muscle tone.
RESEARCH QUESTION


We hypothesized that venlafaxine, a serotonin-norepinephrine reuptake inhibitor, would improve OSA severity.
STUDY DESIGN AND METHODS


In this mechanistic, randomized, double-blind, placebo-controlled crossover trial, 20 patients with OSA underwent two overnight polysomnograms ≥ 4 days apart, receiving either 50 mg of immediate-release venlafaxine or placebo before bedtime. Primary outcomes were the apnea-hypopnea index (AHI) and peripheral oxygen saturation (Spo 2 ) nadir, and secondary outcomes included sleep parameters and pathophysiologic traits; with a view toward understanding the impact of venlafaxine on mechanisms underlying OSA.
RESULTS


Overall, there was no significant difference between venlafaxine and placebo regarding AHI (mean reduction, -5.6 events/h [95% CI, -12.0 to 0.9]; P = .09) or Spo 2  nadir (median increase, +1.0% [-0.5 to 5]; P = .11). Venlafaxine reduced total sleep time, sleep efficiency, and rapid eye movement (REM) sleep, while increasing non-REM stage 1 sleep (P all  < .05). On the basis of exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%; P = .049) and lowered (""worsened"") the predicted arousal threshold (-13%; [P = .02]; ie, more arousable), with no effects on other pathophysiologic traits (P all  ≥ .3). Post hoc analyses further suggested effect modification by arousal threshold (P = .002): AHI improved by 19% in patients with a high arousal threshold (-10.9 events/h [-3.9 to -17.9]) but tended to increase in patients with a low arousal threshold (+7 events/h [-2.0 to 16]). Other predictors of response were elevated AHI and less collapsible upper airway anatomy at baseline (|r| > 0.5, P ≤ .02).
INTERPRETATION


In unselected patients, venlafaxine simultaneously worsened and improved various pathophysiologic traits, resulting in a zero net effect. Careful patient selection based on pathophysiologic traits, or combination therapy with drugs countering its alerting effects, may produce a more robust response.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT02714400; URL: www.clinicaltrials.gov.",2020,"Based on exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%, P=.049) and lowered (""worsened"") the predicted arousal threshold (-13%, P=.02; i.e. more arousable), with no effects on other pathophysiological traits (P all ≥.3).","['and Methods', 'obstructive sleep apnea (OSA', 'Patients with Sleep Apnea ', '20 OSA patients underwent two', 'patients with a high arousal threshold (-10.9/h']","['venlafaxine', 'Venlafaxine', 'overnight polysomnograms >4days apart receiving either 50mg immediate-release venlafaxine or placebo', 'placebo']","['Apnea Hypopnea Index', 'ventilatory response to arousal', 'total sleep time, sleep efficiency and rapid eye movement (REM) sleep', 'pathophysiological traits', 'apnea hypopnea index (AHI) and SpO 2  nadir; secondary outcomes included sleep parameters and pathophysiological traits with a view towards understanding its impact on mechanisms underlying OSA']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",20.0,0.290939,"Based on exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%, P=.049) and lowered (""worsened"") the predicted arousal threshold (-13%, P=.02; i.e. more arousable), with no effects on other pathophysiological traits (P all ≥.3).","[{'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Schmickl', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Yanru', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA; Department of Otorhinolaryngology Head and Neck Surgery, Sleep Medicine Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China. Electronic address: liyanruru@aliyun.com.'}, {'ForeName': 'Jeremy E', 'Initials': 'JE', 'LastName': 'Orr', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jen', 'Affiliation': 'Division of Respiratory Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': 'Sleep and Circadian Medicine Laboratory, Department of Physiology, School of Biomedical Sciences and Biomedical Discovery Institute, Monash University, Melbourne, VIC, Australia; Turner Institute for Brain and Mental Health, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'DeYoung', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}]",Chest,['10.1016/j.chest.2020.02.074']
633,32277364,"Phase I, First-in-Human, Single and Multiple Ascending Dose- and Food-Effect Studies to Assess the Safety, Tolerability and Pharmacokinetics of a Novel Anti-hepatitis B Virus Drug, Bentysrepinine (Y101), in Healthy Chinese Subjects.","BACKGROUND AND OBJECTIVE


Bentysrepinine (Y101), a derivative of repensine (a compound isolated from Dichondra repens Forst), is a novel phenylalanine dipeptide currently under development for the treatment of hepatitis B virus (HBV). The objectives of these studies were to assess the safety, tolerability and pharmacokinetics of bentysrepinine in healthy Chinese subjects.
METHODS


Two randomised, double-blind, placebo-controlled trials evaluated a single oral dose (50-900 mg, study 01) and multiple doses (300 mg and 600 mg, study 02), and a randomised, open, crossover food-effect study (600 mg, study 03) of bentysrepinine was established. Safety and tolerability were assessed by adverse event (AE) reporting, clinical laboratory tests, physical examinations, vital sign monitoring and electrocardiogram (ECG). Plasma, urine and faecal samples were analysed using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods to investigate the pharmacokinetics of bentysrepinine.
RESULTS


Ninety-four subjects were enrolled, and bentysrepinine was well tolerated. Mild and reversible AEs occurred for single and multiple oral doses between 50 and 900 mg. The most common adverse effects were increased alanine aminotransferase (ALT) and aspartate transaminase (AST). Other clinically significant AEs included nausea and elevated urine leukocytes, urine red blood cells, transaminase, creatine kinase, total cholesterol, triglycerides, and low-density cholesterol. There were no clinically significant changes in the ECG, vital signs or laboratory assessments during the studies. The maximum tolerated dose (MTD) was not reached in the dose escalation study. Bentysrepinine was rapidly absorbed and metabolised with a mean time to reach maximum concentration (T max ) between 1-2 h and a mean terminal elimination half-life (t 1/2 ) of approximately 1-3 h. In the single ascending dose study, the exposure including the area under the concentration-time curve (AUC) and the maximum plasma concentration (C max ) of bentysrepinine generally increased in a dose-dependent but not dose-proportional manner in the 50-900 mg dose range. The urinary excretion and faecal excretion of unchanged bentysrepinine were 2.98% and 4.58% of the total dose, respectively. In the multiple-dose study, no accumulation was found after repeated administration at the 300 mg and 600 mg dose levels. The food-effect study using a 600 mg single dose showed that food intake has an obvious effect on the absorption of bentysrepinine from tablets. No experimental differences were found based on sex.
CONCLUSION


Bentysrepinine exhibited acceptable safety and tolerability in healthy subjects in the dose range of 50-900 mg in both single- and multiple-dose studies. The drug did not exhibit linear pharmacokinetic characteristics. No accumulation was observed after the administration of multiple 300 and 600 mg doses. Bentysrepinine is extensively metabolised in the body. Food may increase its bioavailability.
TRIALS REGISTRATION


CFDA registration numbers CTR20160096, CTR20160094, and CTR20140543 (www.chinadrugtrials.org.cn).",2020,Bentysrepinine was rapidly absorbed and metabolised with a mean time to reach maximum concentration (T max ) between 1-2 h and a mean terminal elimination half-life (t 1/2 ) of approximately 1-3 h.,"['healthy Chinese subjects', 'healthy subjects', 'Ninety-four subjects were enrolled, and', 'Healthy Chinese Subjects']","['bentysrepinine', 'Bentysrepinine', 'Novel Anti-hepatitis B Virus Drug, Bentysrepinine', 'placebo']","['bioavailability', 'safety, tolerability and pharmacokinetics', 'Safety, Tolerability and Pharmacokinetics', 'tolerated', 'maximum tolerated dose (MTD', 'Safety and tolerability', 'urinary excretion and faecal excretion of unchanged bentysrepinine', 'ECG, vital signs or laboratory assessments', 'concentration-time curve (AUC) and the maximum plasma concentration (C max ) of bentysrepinine', 'Plasma, urine and faecal samples', 'acceptable safety and tolerability', 'nausea and elevated urine leukocytes, urine red blood cells, transaminase, creatine kinase, total cholesterol, triglycerides, and low-density cholesterol', 'adverse event (AE) reporting, clinical laboratory tests, physical examinations, vital sign monitoring and electrocardiogram (ECG', 'Mild and reversible AEs', 'alanine aminotransferase (ALT) and aspartate transaminase (AST']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C3493298', 'cui_str': 'N-(N-benzoyl-O-(2-dimethylaminoethyl)-L-tyrosyl)-L-phenylalaninol'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C3493298', 'cui_str': 'N-(N-benzoyl-O-(2-dimethylaminoethyl)-L-tyrosyl)-L-phenylalaninol'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0555120', 'cui_str': 'Urine micr.:leukocytes present'}, {'cui': 'C0427827', 'cui_str': 'Urine: red - blood'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}]",94.0,0.106305,Bentysrepinine was rapidly absorbed and metabolised with a mean time to reach maximum concentration (T max ) between 1-2 h and a mean terminal elimination half-life (t 1/2 ) of approximately 1-3 h.,"[{'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Department of Pharmaceutics, College of Pharmaceutical Science, Soochow University, Suzhou, China.'}, {'ForeName': 'Shichao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmaceutics, College of Pharmaceutical Science, Soochow University, Suzhou, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Linsheng', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'Bailing Enterprise Group Pharmaceutical Co., Ltd., Guizhou, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': 'Bailing Enterprise Group Pharmaceutical Co., Ltd., Guizhou, China.'}, {'ForeName': 'Chenrong', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China. chrishuangcr@163.com.'}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'Miao', 'Affiliation': 'Department of Clinical Pharmacology, The First Affiliated Hospital of Soochow University, No. 899, Pinghai Street, Suzhou, 215006, China. miaoliyan@suda.edu.cn.'}]",Clinical drug investigation,['10.1007/s40261-020-00909-3']
634,32277388,Comparative Study to Evaluate Tolerability of Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions in Treatment of Androgenetic Alopecia in Indian Men: Randomized Double-Blind Study.,"INTRODUCTION


Patients with androgenetic alopecia treated with alcohol-based minoxidil topical solutions often report local irritation, dryness, and redness of the scalp. We evaluate the in-use tolerance of 5% minoxidil novel formulation topical solution-test product (TP)-compared with 5% minoxidil alcohol-based topical solutions-reference product 1 (RP1) and reference product 2 (RP2)-in Indian men with androgenetic alopecia.
METHODS


In this randomized double-blind study, patients aged ≥ 18 years with androgenetic alopecia were randomized 1:1:1 to apply TP, RP1, and RP2 twice daily for 30 days. The safety endpoints included mean hydration, mean redness, and mean scaling on scalp.
RESULTS


All screened patients (N = 100) were enrolled and randomized to TP (n = 33), RP1 (n = 33), or RP2 (n = 34). At day 30, the mean (SD) hydration was significantly increased in patients treated with TP [9.74 (4.98)] but significantly reduced in patients treated with RP1 [3.28 (2.67)] or RP2 [3.03 (1.57)] (p-value 0.001). The mean (SD) score for redness was significantly decreased in the TP group [0.01 (0.04)], (p-value, 0.009) at day 30 compared with baseline, while no change was observed in the RP1 [0.08 (0.13)] or RP2 [0.11 (0.17)] group. After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups.
CONCLUSIONS


Twice daily application of 5% minoxidil novel formulation for 30 days significantly improved hydration and reduced redness of the scalp. Hence, 5% minoxidil novel formulation could be a safer alternative in treating men with androgenetic alopecia who are sensitive to alcoholic formulations.
TRIAL REGISTRATION


Clinical Trial Registry of India; CTRI/2018/11/016431.",2020,"After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups.
","['Indian men with androgenetic alopecia', 'men with androgenetic alopecia who are sensitive to alcoholic formulations', 'Patients with androgenetic alopecia treated with', 'All screened patients (N\u2009=\u2009100', '18\xa0years with androgenetic alopecia', 'patients aged\u2009≥', 'Indian Men']","['minoxidil', 'alcohol-based minoxidil topical solutions', 'TP', 'Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions', 'minoxidil novel formulation topical solution-test product (TP)-compared with 5% minoxidil alcohol-based topical solutions-reference product 1 (RP1) and reference product 2 (RP2)-in']","['hydration and reduced redness of the scalp', 'mean (SD) score for redness', 'mean score of scaling', 'mean hydration, mean redness, and mean scaling on scalp', 'mean (SD) hydration', 'Androgenetic Alopecia']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0332324', 'cui_str': 'Sensitive'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0307514', 'cui_str': 'Minoxidil Topical Solution [Rogaine]'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0991555', 'cui_str': 'Cutaneous solution'}]","[{'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]",100.0,0.0681424,"After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups.
","[{'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Sarkar', 'Affiliation': 'Department of Dermatology, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Vartak', 'Affiliation': 'C.L.A.I.M.S. Pvt Ltd, Mumbai, Maharashtra, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Nikhil Kumar', 'Initials': 'NK', 'LastName': 'Kursam', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Amey', 'Initials': 'A', 'LastName': 'Mane', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Suyog', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Sujeet Narayan', 'Initials': 'SN', 'LastName': 'Charugulla', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India. sujeetnc@drreddys.com.""}]",Dermatology and therapy,['10.1007/s13555-020-00374-y']
635,32252241,Vitamin D 3  Supplementation Increases Long-Chain Ceramide Levels in Overweight/Obese African Americans: A Post-Hoc Analysis of a Randomized Controlled Trial.,"Sphingolipid metabolism plays a critical role in cell growth regulation, lipid regulation, neurodevelopment, type 2 diabetes, and cancer. Animal experiments suggest that vitamin D may be involved in sphingolipid metabolism regulation. In this study, we tested the hypothesis that vitamin D supplementation would alter circulating long-chain ceramides and related metabolites involved in sphingolipid metabolism in humans. We carried out a post-hoc analysis of a previously conducted randomized, placebo-controlled clinical trial in 70 overweight/obese African-Americans, who were randomly assigned into four groups of 600, 2000, 4000 IU/day of vitamin D 3  supplements or placebo for 16 weeks. The metabolites were measured in 64 subjects (aged 26.0 ± 9.4 years, 17% male). Serum levels of  N -stearoyl-sphingosine (d18:1/18:0) (C18Cer) and stearoyl sphingomyelin (d18:1/18:0) (C18SM) were significantly increased after vitamin D 3  supplementation ( p s < 0.05) in a dose-response fashion. The effects of 600, 2000, and 4000 IU/day vitamin D 3  supplementation on C18Cer were 0.44 ( p  = 0.049), 0.52 ( p  = 0.016), and 0.58 ( p  = 0.008), respectively. The effects of three dosages on C18SM were 0.30 ( p  = 0.222), 0.61 ( p  = 0.009), and 0.68 ( p  = 0.004), respectively. This was accompanied by the significant correlations between serum 25-hydroxyvitamin D 3  [25(OH)D] concentration and those two metabolites ( p s < 0.05). Vitamin D 3  supplementations increase serum levels of C18Cer and C18SM in a dose-response fashion among overweight/obese African Americans.",2020,(C18SM) were significantly increased after vitamin D 3  supplementation ( p s < 0.05) in a dose-response fashion.,"['64 subjects (aged 26.0 ± 9.4 years, 17% male', 'overweight/obese African Americans', '70 overweight/obese African-Americans', 'humans', 'Overweight/Obese African Americans']","['vitamin D supplementation', 'placebo', 'Vitamin D 3  supplementations', 'Vitamin D 3  Supplementation Increases', 'vitamin D', 'vitamin D 3  supplements or placebo']","['Serum levels of  N -stearoyl-sphingosine (d18:1/18:0) (C18Cer) and stearoyl sphingomyelin (d18:1/18:0', 'serum levels of C18Cer and C18SM', '25-hydroxyvitamin D 3  [25(OH)D] concentration']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037907', 'cui_str': 'Sphingosine'}, {'cui': 'C0037906', 'cui_str': 'Sphingomyelin'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",70.0,0.524224,(C18SM) were significantly increased after vitamin D 3  supplementation ( p s < 0.05) in a dose-response fashion.,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Georgia Prevention Institute, Department of Medicine, Medical College of Georgia, Augusta University, Augusta, GA 30912, USA.'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Georgia Prevention Institute, Department of Medicine, Medical College of Georgia, Augusta University, Augusta, GA 30912, USA.'}, {'ForeName': 'Jigar', 'Initials': 'J', 'LastName': 'Bhagatwala', 'Affiliation': 'Department of Medicine, Medical College of Georgia, Augusta University, Augusta, GA 30912, USA.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Raed', 'Affiliation': 'Department of Medicine, Medical College of Georgia, Augusta University, Augusta, GA 30912, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Georgia Prevention Institute, Department of Medicine, Medical College of Georgia, Augusta University, Augusta, GA 30912, USA.'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Georgia Prevention Institute, Department of Medicine, Medical College of Georgia, Augusta University, Augusta, GA 30912, USA.'}]",Nutrients,['10.3390/nu12040981']
636,32276360,Impact of Medication Regimen Simplification on Medication Administration Times and Health Outcomes in Residential Aged Care: 12 Month Follow Up of the SIMPLER Randomized Controlled Trial.,"In the SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER) cluster-randomized controlled trial, we evaluated the impact of structured medication regimen simplification on medication administration times, falls, hospitalization, and mortality at 8 residential aged care facilities (RACFs) at 12 month follow up. In total, 242 residents taking ≥1 medication regularly were included. Opportunities for simplification among participants at 4 RACFs were identified using the validated Medication Regimen Simplification Guide for Residential Aged CarE (MRS GRACE). Simplification was possible for 62 of 99 residents in the intervention arm. Significant reductions in the mean number of daily medication administration times were observed at 8 months (-0.38, 95% confidence intervals (CI) -0.69 to -0.07) and 12 months (-0.47, 95%CI -0.84 to -0.09) in the intervention compared to the comparison arm. A higher incidence of falls was observed in the intervention arm (incidence rate ratio (IRR) 2.20, 95%CI 1.33 to 3.63) over 12-months, which was primarily driven by a high falls rate in one intervention RACF and a simultaneous decrease in comparison RACFs. No significant differences in hospitalizations (IRR 1.78, 95%CI 0.57-5.53) or mortality (relative risk 0.81, 95%CI 0.48-1.38) over 12 months were observed. Medication simplification achieves sustained reductions in medication administration times and should be implemented using a structured resident-centered approach that incorporates clinical judgement.",2020,"No significant differences in hospitalizations (IRR 1.78, 95%CI 0.57-5.53) or mortality (relative risk 0.81, 95%CI 0.48-1.38) over 12 months were observed.","['Residential Aged Care', '242 residents taking ≥1 medication regularly were included', 'participants at 4 RACFs']",[],"['Medication Administration Times and Health Outcomes', 'medication administration times, falls, hospitalization, and mortality', 'mortality', 'mean number of daily medication administration times', 'hospitalizations']","[{'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",4.0,0.104562,"No significant differences in hospitalizations (IRR 1.78, 95%CI 0.57-5.53) or mortality (relative risk 0.81, 95%CI 0.48-1.38) over 12 months were observed.","[{'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Sluggett', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, VIC 3052, Australia.'}, {'ForeName': 'Ria E', 'Initials': 'RE', 'LastName': 'Hopkins', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, VIC 3052, Australia.'}, {'ForeName': 'Esa Yh', 'Initials': 'EY', 'LastName': 'Chen', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, VIC 3052, Australia.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Ilomäki', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, VIC 3052, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Corlis', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Hornsby Ku-ring-gai Hospital, Sydney, NSW 2077, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Van Emden', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Hornsby Ku-ring-gai Hospital, Sydney, NSW 2077, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hogan', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Hornsby Ku-ring-gai Hospital, Sydney, NSW 2077, Australia.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Caporale', 'Affiliation': 'Helping Hand Aged Care, Adelaide, SA 5006, Australia.'}, {'ForeName': 'Choon Ean', 'Initials': 'CE', 'LastName': 'Ooi', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, VIC 3052, Australia.'}, {'ForeName': 'Sarah N', 'Initials': 'SN', 'LastName': 'Hilmer', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Hornsby Ku-ring-gai Hospital, Sydney, NSW 2077, Australia.'}, {'ForeName': 'J Simon', 'Initials': 'JS', 'LastName': 'Bell', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, VIC 3052, Australia.'}]",Journal of clinical medicine,['10.3390/jcm9041053']
637,32278870,Impact of Presence of Inferior Vena Cava Filter on Iliocaval Stent Outcomes.,"BACKGROUND


The impact of presence of an IVC filter in patients undergoing stenting for symptomatic femoroiliocaval obstruction has not been explored in detail. This study attempts to fill this gap by evaluating clinical and stent-related outcomes in such patients. The incidence of deep vein thrombosis (DVT) in this setting is also analyzed.
METHODS


A retrospective review of contemporaneously entered EMR data on initial iliocaval stents placed in patients with an indwelling IVC filter (or placed after stenting) over a 15-year period from 2000 to 2015 was performed. A separate matched cohort that underwent initial stenting during the time frame, but which did not have an IVC filter, was utilized as the control group. Clinical outcomes were evaluated through use of the venous clinical severity score (VCSS) and visual analog scale (VAS) pain scores. Incidence of deep venous thrombosis after stenting was also reviewed in both groups. The Kaplan-Meier analysis was used to assess stent patency after intervention while t-tests were used to examine preintervention and postintervention outcomes within and in-between groups.
RESULTS


A total of 50 limbs (40 patients) underwent placement of a femoroiliocaval stent in the setting of a preexisting (49) or post-stent (1) IVC filter [filter group]. The control group had 156 limbs (155 patients). There was no difference in VCSS, VAS pain score, or grade of swelling at baseline between the 2 groups. Over the median follow-up duration (43 months-filter group; 40 months-control group), VCSS went from 6 to 4 at 12 months (P = 0.0001) in the filter group and from 6 to 4 in the control group (P < 0.0001). VAS pain scores went from 7 to 0 at 12 months (P < 0.0001) in the filter group and from 5 to 0 in the control group (P < 0.0001). There was no significant difference in the VCSS scores or VAS pain score between the 2 groups at 12 months (P > 0.05). Overall, there was a statistically significant increase in the incidence of DVT in the filter group (10%) compared to the control group (3%) [P = 0.03%]. Primary, primary assisted, and secondary patencies in the filter/control groups at 48 months were 64%/65% (P = 0.6), 100%/97% (P = 0.5), and 100%/75% (P = 0.4), respectively. Reintervention from in-stent restenosis was noted in 16% of patients in the filter group compared to 4% in the control group (P = 0.006).
CONCLUSIONS


Patients with an IVC filter in the setting of a femoroiliocaval stent tend to have an increased rate of deep venous thrombosis on the stented side. In addition, an increased rate of reintervention secondary to in-stent restenosis was also noted. In light of this, every attempt should be made to remove the IVC filter as soon as the need for the filter no longer exists.",2020,VAS pain scores went from 7 to 0 at 12 months (p<0.0001) in the filter group and from 5 to 0 in the control group (p=<0.0001).,"['patients with an indwelling IVC filter (or placed post stenting) over a 15-year period from 2000 to 2015 was performed', 'A total of 50 limbs (40 patients) underwent', 'patients undergoing stenting for symptomatic femoroiliocaval obstruction']","['IVC filter', 'placement of a femoroiliocaval stent in the setting of a pre-existing (49) or post stent (1) IVC filter [filter group', 'inferior vena cava filter']","['venous clinical severity score (VCSS) and VAS pain scores', 'VCSS, VAS pain score or grade of swelling', 'Reintervention from instent restenosis', 'Incidence of deep venous thrombosis post stenting', 'incidence of deep venous thrombosis (DVT', 'VCSS scores or VAS pain score', 'Mean primary, primary assisted and secondary patencies', 'rate of deep venous thrombosis', 'rate of reintervention secondary to instent restenosis', 'VAS pain scores', 'incidence of DVT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0080306', 'cui_str': 'Vena cava filter'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}]",,0.047803,VAS pain scores went from 7 to 0 at 12 months (p<0.0001) in the filter group and from 5 to 0 in the control group (p=<0.0001).,"[{'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Jayaraj', 'Affiliation': 'The RANE Center for Venous & Lymphatic Diseases, St. Dominic Hospital, Jackson, MS. Electronic address: jayaraj.arjun2015@gmail.com.'}, {'ForeName': 'Chandler', 'Initials': 'C', 'LastName': 'Noel', 'Affiliation': 'The RANE Center for Venous & Lymphatic Diseases, St. Dominic Hospital, Jackson, MS.'}, {'ForeName': 'Seshadri', 'Initials': 'S', 'LastName': 'Raju', 'Affiliation': 'The RANE Center for Venous & Lymphatic Diseases, St. Dominic Hospital, Jackson, MS.'}]",Annals of vascular surgery,['10.1016/j.avsg.2020.03.041']
638,32252250,The Effects of Low- and High-Glycemic Index Sport Nutrition Bars on Metabolism and Performance in Recreational Soccer Players.,"Consumption of low-glycemic index (GI) carbohydrates (CHO) may be superior to high-GI CHO before exercise by increasing fat oxidation and decreasing carbohydrate oxidation. We compared the effects of pre-exercise feeding of a low-GI lentil-based sports nutrition bar with a high-GI bar on metabolism and performance during a simulated soccer match. Using a randomized, double-blind, counterbalanced, crossover design, participants ( n  = 8) consumed 1.5 g/kg available CHO from a low-GI bar (GI = 45) or high-GI bar (GI = 101) two hours before a 90 min simulated soccer match, and 0.38 g/kg body mass during a 15 min half-time break. The test involved alternating 6 min intervals of paced jogging, running, walking, and sprinting, and 3 min intervals of soccer-specific skills (timed ball dribbling, agility running, heading, kicking accuracy). Carbohydrate oxidation rate was lower during the match after consuming the low-GI compared to high-GI bar (2.17 ± 0.6 vs. 2.72 ± 0.4 g/min;  p  < 0.05). Participants performed better during the low-GI versus high-GI bar condition on the agility test (5.7 ± 0.4 versus 6.1 ± 0.6 s;  p  < 0.01) and heading (i.e., jumping height 24.7 ± 4.3 versus 22.2 ± 4.5 cm;  p  < 0.01) late in the soccer match (72 min). A low-GI lentil-based sports nutrition bar provides a metabolic benefit (lower carbohydrate oxidation rate) and a modest improvement in agility running and jumping height (heading) late in the test.",2020,"Participants performed better during the low-GI versus high-GI bar condition on the agility test (5.7 ± 0.4 versus 6.1 ± 0.6 s;  p  < 0.01) and heading (i.e., jumping height 24.7 ± 4.3 versus 22.2 ± 4.5 cm;  p  < 0.01) late in the soccer match (72 min).",['Recreational Soccer Players'],"['paced jogging, running, walking, and sprinting, and 3 min intervals of soccer-specific skills (timed ball dribbling, agility running, heading, kicking accuracy', 'Low- and High-Glycemic Index Sport Nutrition Bars', 'pre-exercise feeding of a low-GI lentil-based sports nutrition bar with a high-GI', 'low-glycemic index (GI) carbohydrates (CHO']","['agility running and jumping height (heading) late', 'Carbohydrate oxidation rate']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",,0.0469766,"Participants performed better during the low-GI versus high-GI bar condition on the agility test (5.7 ± 0.4 versus 6.1 ± 0.6 s;  p  < 0.01) and heading (i.e., jumping height 24.7 ± 4.3 versus 22.2 ± 4.5 cm;  p  < 0.01) late in the soccer match (72 min).","[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Kaviani', 'Affiliation': 'School of Nutrition and Dietetics, Faculty of Pure & Applied Science, Acadia University, Wolfville, Nova Scotia, NS B4P 2R6, Canada.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Chilibeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, 87 Campus Dr, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Gall', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, 87 Campus Dr, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jochim', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, 87 Campus Dr, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Gordon A', 'Initials': 'GA', 'LastName': 'Zello', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, 107 Wiggins Rd, Saskatoon, SK S7N 5E5, Canada.'}]",Nutrients,['10.3390/nu12040982']
639,32086551,Neural responses in the pain matrix when observing pain of others are unaffected by testosterone administration in women.,"There is evidence of testosterone having deteriorating effects on cognitive and affective empathic behaviour in men and women under varying conditions. However, whether testosterone influences empathy for pain has not yet been investigated. Therefore, we tested neural responses to witnessing others in pain in a within-subject placebo-controlled testosterone administration study in healthy young women. Using functional magnetic resonance imaging, we provide affirming evidence that an empathy-inducing paradigm causes changes in the activity throughout the pain circuitry, including the bilateral insula and anterior cingulate cortex. Administration of testosterone, however, did not influence these activation patterns in the pain matrix. Testosterone has thus downregulating effects on aspects of empathic behaviour, but based on these data does not seem to influence neural responses during empathy for others' pain. This finding gives more insight into the role of testosterone in human empathy.",2020,There is evidence of testosterone having deteriorating effects on cognitive and affective empathic behaviour in men and women under varying conditions.,"['men and women under varying conditions', 'healthy young women']","['placebo-controlled testosterone', 'Testosterone', 'testosterone']",['cognitive and affective empathic behaviour'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]",[],,0.324285,There is evidence of testosterone having deteriorating effects on cognitive and affective empathic behaviour in men and women under varying conditions.,"[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Heany', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Terburg', 'Affiliation': 'Department of Experimental Psychology, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'van Honk', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Bos', 'Affiliation': 'Institute of Education and Child Studies, Leiden University, Leiden, The Netherlands. p.a.bos@fsw.leidenuniv.nl.'}]",Experimental brain research,['10.1007/s00221-020-05749-3']
640,32277008,Effects of Weight Loss and Weight Regain on Circulating Biomarkers in Overweight/Obese Breast Cancer Survivors Enrolled in a Weight Loss Trial in the Rural Midwest.,"BACKGROUND


Obesity is associated with worse breast cancer prognosis, however little is known about the level of weight loss required to improve pathway biomarkers. The effects of weight regain on biomarkers are also largely unknown.
METHODS


Overweight/obese breast cancer survivors enrolled in an 18-month behavioral weight loss trial provided weight and serum biomarkers [leptin, adiponectin, insulin, plasminogen activator inhibitor-1 (PAI-1), IL-6, TNFα, and hepatocyte growth factor HGF] at baseline, 6, and 18 months ( n  = 138). Change in biomarkers over time and by weight loss thresholds were examined.
RESULTS


Mean weight loss at 6 months was 13.3 ± 5.0 kg; from 6 to 18 months, mean regain was 4.0 ± 5.2 kg. Favorable biomarker modulations were observed at 6 months for leptin, adiponectin, insulin, PAI-1, IL-6, and HGF ( P  < 0.006 to  P  < 0.0001). These changes remained significant overall at 18 months despite attenuation in some. Women who lost <10% of baseline weight showed significantly smaller modulation effects for leptin ( P  < 0.0001), adiponectin:leptin (A/L) ratio ( P  < 0.0001), PAI-1 ( P  < 0.001), and insulin ( P  = 0.003) compared with women who lost >10%. Women who lost >10% observed a significant increase in adiponectin ( P  < 0.0001), and these women continued to show improved adiponectin from 6 to 18 months despite weight regain. Physical activity contributed additional effects on biomarker change for leptin, A/L ratio, and PAI-1.
CONCLUSIONS


These findings are consistent with a clinical target of 10% weight.
IMPACT


Sustained increases in adiponectin likely confer benefits for breast cancer prognosis even with weight regain.",2020,"Favorable biomarker modulations were observed at 6 months for leptin, adiponectin, insulin, PAI-1, IL-6, and HGF (p<0.006 to p<0.0001).","['Overweight/Obese Breast Cancer Survivors Enrolled in a Weight Loss Trial in the Rural Midwest', 'Overweight/obese breast cancer survivors enrolled in an 18-month behavioral weight loss trial provided']",['Weight Loss and Weight Regain'],"['Favorable biomarker modulations', 'smaller modulation effects for leptin (p<0.0001), adiponectin:leptin (A/L) ratio (p<0.0001), PAI-1', 'biomarker change for leptin, A/L ratio, and PAI-1', 'leptin, adiponectin, insulin, PAI-1, IL-6, and HGF', 'PAI-1], interleukin-6 [IL-6], tumor necrosis factor alpha [TNFα], and hepatocyte growth factor [HGF', 'Mean weight loss', 'adiponectin', 'weight and serum biomarkers (leptin, adiponectin, insulin, plasminogen activator inhibitor-1']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0062534', 'cui_str': 'Scatter Factor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",138.0,0.0228327,"Favorable biomarker modulations were observed at 6 months for leptin, adiponectin, insulin, PAI-1, IL-6, and HGF (p<0.006 to p<0.0001).","[{'ForeName': 'Christie A', 'Initials': 'CA', 'LastName': 'Befort', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas. cbefort@kumc.edu.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Kimler', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Leonidas E', 'Initials': 'LE', 'LastName': 'Bantis', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Phillips', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Fabian', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-1572']
641,32277258,Listening to music while running alters ground reaction forces: a study of acute exposure to varying speed and loudness levels in young women and men.,"PURPOSE


Music listening while running enhances physiological and psychological features, resulting in a more enjoyable experience. The possible influence of music on ground reaction forces (GRF) during running, however, is unknown. Considering the 'distracting' role of music on runner's attention, we hypothesized that music would cover foot impacts against the ground. This study verified such hypothesis by testing the effects of different music volumes while running at different velocities.
METHODS


Fifty fit volunteers (F:M = 22:8; 23 ± 2 years) performed 2-min running stints over 3 random conditions (80-dB, 85-dB music; 'no music'), at 3 velocities (8, 10, 12 km/h). Participants ran on a sensorized treadmill that recorded GRF during all experiments.
RESULTS


Listening to 85-dB music resulted in greater GRF at 8 (p = 0.0005) and 10 km/h (p = 0.04) but not 12 km/h (p = 0.35) and not with 80-dB volume. Gender-based analyses revealed significant Condition × gender interactions only for 85-dB music vs. 'no music'. Bonferroni-adjusted comparisons revealed significant music-induced increases in GRF only in men at 8 km/h (+ 4.1 kg/cm 2 , p < 0.0005; women: + 0.8 kg/cm 2 , p = 0.47) and 10 km/h (+ 3.3 kg/cm 2 , p = 0.004; women: + 0.8 kg/cm 2 , p = 0.51) but not at 12 km/h.
CONCLUSION


In active men, listening to loud music while running results in increased GRF, whereas no effect was observed in women. The lack of music effect in women may be related to structural factors, such as larger hip width-to-femoral length ratio, possibly resulting in different loading patterns. The present preliminary findings introduce high-volume music listening as a new potential risk factor for injury in young runners.",2020,"RESULTS


Listening to 85-dB music resulted in greater GRF at 8 (p = 0.0005) and 10 km/h (p = 0.04) but not 12 km/h (p = 0.35) and not with 80-dB volume.","['Fifty fit volunteers (F:M\u2009=\u200922:8; 23\u2009±\u20092 years) performed', 'young women and men', 'young runners']","[""2-min running stints over 3 random conditions (80-dB, 85-dB music; 'no music"", 'sensorized treadmill that recorded GRF', 'Listening to music while running alters ground reaction forces']",['GRF'],"[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",50.0,0.253089,"RESULTS


Listening to 85-dB music resulted in greater GRF at 8 (p = 0.0005) and 10 km/h (p = 0.04) but not 12 km/h (p = 0.35) and not with 80-dB volume.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Manca', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Viale S. Pietro 43/b, 07100, Sassari, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Cugusi', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Viale S. Pietro 43/b, 07100, Sassari, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Pomidori', 'Affiliation': 'Esercizio Vita Medical Fitness, Ferrara, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Felisatti', 'Affiliation': 'Esercizio Vita Medical Fitness, Ferrara, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Altavilla', 'Affiliation': 'Esercizio Vita Medical Fitness, Ferrara, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Zocca', 'Affiliation': 'Esercizio Vita Medical Fitness, Ferrara, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Zocca', 'Affiliation': 'Esercizio Vita Medical Fitness, Ferrara, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bussu', 'Affiliation': 'Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Zeevi', 'Initials': 'Z', 'LastName': 'Dvir', 'Affiliation': 'Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Deriu', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Viale S. Pietro 43/b, 07100, Sassari, Italy. deriuf@uniss.it.'}]",European journal of applied physiology,['10.1007/s00421-020-04371-z']
642,32277344,Comparable Effect of Two-Step Versus Extended Infusions on the Pharmacokinetics of Imipenem in Patients with Sepsis and Septic Shock.,"INTRODUCTION


The present study aimed to compare the pharmacokinetic/pharmacodynamic (PK/PD) parameters of imipenem administered by two-step (50% delivered in a 30-min bolus, 50% for the following 90 min) or extended (administered continuously for 2 h) infusion.
METHODS


Patients with sepsis and septic shock were prospectively enrolled and randomized into four groups. Subjects in the two-step or extended groups were given two doses of imipenem (0.5 g q6h and 1.0 g q8h). The plasma imipenem concentrations were measured at given time points after the fifth dose. The PK/PD target was defined as the achievement of a fractional time above the minimal inhibitory concentration (MIC) of > 40%.
RESULTS


Thirty-five patients were eventually enrolled. No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05). All four groups achieved 40% T > MIC when MIC was 0.5-4.0 μg/ml, but only regimens with a higher dose (1.0 g q8h) achieved target when MIC was 8 μg/ml.
CONCLUSION


The two-step and extended regimens of imipenem are comparable to the PK/PD target in the treatment of sepsis and septic shock. A higher dose (1.0 g q8h) should be considered for target achievement at an MIC of > 8 μg/ml.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02616354.",2020,"No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05).","['Patients with Sepsis and Septic Shock', 'Patients with sepsis and septic shock', 'Thirty-five patients were eventually enrolled']","['Imipenem', 'imipenem']","['plasma imipenem concentrations', 'pharmacokinetic/pharmacodynamic (PK/PD) parameters', 'percentage of patients achieving 40% T\u2009>\u2009MIC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C4319605', 'cui_str': '35'}]","[{'cui': 'C0020933', 'cui_str': 'Imipenem'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}]",35.0,0.14188,"No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05).","[{'ForeName': 'Yingzi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Pharmacy Department, Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Zha', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Songqiao', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China. yiyiyang2004@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01339-5']
643,31981645,Use of rapid reading software to reduce capsule endoscopy reading times while maintaining accuracy.,"BACKGROUNDS AND AIMS


A typical capsule endoscopy (CE) case generates tens of thousands of images, with abnormalities often confined to a just few frames. Omni Mode is a novel EndoCapsule software algorithm (Olympus, Tokyo, Japan) that proposes to intelligently remove duplicate images while maintaining accuracy in lesion detection.
METHODS


This prospective multicenter study took place across 9 European centers. Consecutive, unselected CE cases were read conventionally in normal mode, with every captured frame reviewed. Cases were subsequently anonymized and randomly allocated to another center where they were read using Omni Mode. Detected lesions and reading times were recorded, with findings compared between both viewing modes. The clinical significance of lesions was described according to the P classification (P0, P1, and P2). Where a discrepancy in lesion detection in either mode was found, expert blinded review at a consensus meeting was undertaken.
RESULTS


The patient population undergoing CE had a mean age of 49.5 years (range, 18-91), with the investigation of anemia or GI bleeding accounting for 71.8% of cases. The average small-bowel transit time was 4 hours, 26 minutes. The mean reading time in normal mode was 42.5 minutes. The use of Omni Mode was significantly faster (P < .0001), with an average time saving of 24.6 minutes (95% confidence interval, 22.8-26.9). The 2127 lesions were identified and classified according to the P classification as P0 (1234), P1 (656), and P2 (237). Lesions were identified using both reading modes in 40% (n = 936), and 1186 lesions were identified by either normal or Omni Mode alone. Normal mode interpretation was associated with 647 lesions being missed, giving an accuracy of .70. Omni Mode interpretation led to 539 lesions being missed, with an accuracy of .75. There was no significant difference in clinical conclusions made between either reading mode.
CONCLUSIONS


This study shows that CE reading times can be reduced by an average of 40%, without any reduction in clinical accuracy.",2020,"The use of Omni Mode was significantly faster (P<0.0001), with an average time saving of 24.6 minutes (95% CI, 22.8 - 26.9).A total of 2172 lesions were identified, which were classified according to the P-classification as P0 (1234), P1 (656), and P2 (237).","['patient population undergoing capsule endoscopy had a mean age of 49.5 years (range 18 - 91), with the investigation of anemia or gastrointestinal bleeding accounting for 71.8% of cases']",[],"['Detected lesions and reading time', 'mean reading time', 'average small-bowel transit time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1721048', 'cui_str': 'Video Capsule Endoscopy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0000938', 'cui_str': 'Accounting'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",[],"[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}]",2172.0,0.0242448,"The use of Omni Mode was significantly faster (P<0.0001), with an average time saving of 24.6 minutes (95% CI, 22.8 - 26.9).A total of 2172 lesions were identified, which were classified according to the P-classification as P0 (1234), P1 (656), and P2 (237).","[{'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Beg', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom; Nottingham Digestive Diseases Centre, The University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wronska', 'Affiliation': 'Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland; Department of Gastroenterological Oncology, Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Isis', 'Initials': 'I', 'LastName': 'Araujo', 'Affiliation': 'Gastroenterology Department, ICMDiM, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Begona', 'Initials': 'B', 'LastName': 'González Suárez', 'Affiliation': 'Gastroenterology Department, ICMDiM, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Ivanova', 'Affiliation': 'Department of Gastroenterology, Moscow University Hospital N31, Pirogov Russia National Research Medical University, Moscow, Russia.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Fedorov', 'Affiliation': 'Department of Gastroenterology, Moscow University Hospital N31, Pirogov Russia National Research Medical University, Moscow, Russia.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Aabakken', 'Affiliation': 'Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Seitz', 'Affiliation': 'Department of Gastroenterology, University Hospital Heidelberg, Heppenheim, Germany.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Rey', 'Affiliation': 'Hepato-Gastroenterology Department, Institut Arnault Tzanck, St. Laurent du Var, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Saurin', 'Affiliation': 'Department of Endoscopy and Gastroenterology, Pavillon L, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Tari', 'Affiliation': 'Gastroenterology Division, Azienda Ospedaliero Universitaria ""Maggiore della Carità"", Novara, Italy.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Card', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom; Division of Epidemiology and Public Health, School of Medicine The University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Krish', 'Initials': 'K', 'LastName': 'Ragunath', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom; Nottingham Digestive Diseases Centre, The University of Nottingham, Nottingham, United Kingdom.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.01.026']
644,32001481,FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1.,"On March 8, 2019, the FDA granted accelerated approval to atezolizumab in combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 [PD-L1 stained tumor-infiltrating immune cells (IC) of any intensity covering ≥1% of the tumor area], as determined by an FDA-approved test. Approval was based on data from IMpassion130, which randomized patients to receive atezolizumab or placebo in combination with paclitaxel protein-bound. Investigator-assessed progression-free survival (PFS) in the intent-to-treat (ITT) and PD-L1-positive populations were coprimary endpoints. After 13-month median follow-up, the estimated median PFS in the PD-L1-positive population was 7.4 months in the atezolizumab arm and 4.8 months in the placebo arm [HR = 0.60; 95% confidence interval (CI), 0.48-0.77]. Overall survival (OS) results were immature with 43% deaths in the ITT population, representing 59% of the OS events required to perform the final OS analysis. Adverse reactions occurring in ≥20% of patients receiving atezolizumab with paclitaxel protein-bound were alopecia, peripheral neuropathies, fatigue, nausea, diarrhea, anemia, constipation, cough, headache, neutropenia, vomiting, and decreased appetite. Accelerated approval was appropriate taking into account the unmet medical need along with the immaturity of the OS results and potential for PFS in the PD-L1-expressing population to predict clinical benefit.",2020,Investigator-assessed progression-free survival (PFS) in the intent-to-treat (ITT) and PD-L1-positive populations were co-primary endpoints.,"['patients with advanced or metastatic TNBC whose tumors express PD-L1', 'adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC']","['placebo', 'atezolizumab', 'atezolizumab or placebo']","['median PFS', 'Overall survival results', 'Adverse reactions', 'alopecia, peripheral neuropathies, fatigue, nausea, diarrhea, anemia, constipation, cough, headache, neutropenia, vomiting, and decreased appetite', 'Investigator-assessed progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0589049,Investigator-assessed progression-free survival (PFS) in the intent-to-treat (ITT) and PD-L1-positive populations were co-primary endpoints.,"[{'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. preeti.narayan@fda.hhs.gov.'}, {'ForeName': 'Sakar', 'Initials': 'S', 'LastName': 'Wahby', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gao', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Amiri-Kordestani', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bloomquist', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Bellinda L', 'Initials': 'BL', 'LastName': 'King-Kallimanis', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Hou', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Yutao', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Kalavar', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Soma', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Philip', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Theoret', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Blumenthal', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Sridhara', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3545']
645,31930993,Health resource utilization of labor induction versus expectant management.,"BACKGROUND


Although induction of labor of low-risk nulliparous women at 39 weeks reduces the risk of cesarean delivery compared with expectant management, concern regarding more frequent use of labor induction remains, given that this intervention historically has been thought to incur greater resource utilization.
OBJECTIVE


The objective of the study was to determine whether planned elective labor induction at 39 weeks among low-risk nulliparous women, compared with expectant management, was associated with differences in health care resource utilization from the time of randomization through 8 weeks postpartum.
STUDY DESIGN


This is a planned secondary analysis of a multicenter randomized trial in which low-risk nulliparous women were assigned to induction of labor at 39 weeks or expectant management. We assessed resource utilization after randomization in 3 time periods: antepartum, delivery admission, and discharge through 8 weeks postpartum.
RESULTS


Of 6096 women with data available, those in the induction of labor group (n = 3059) were significantly less likely in the antepartum period after randomization to have at least 1 ambulatory visit for routine prenatal care (32.4% vs 68.4%), unanticipated care (0.5% vs 2.6%), or urgent care (16.2% vs 44.3%), or at least 1 antepartum hospitalization (0.8% vs 2.2%, P < .001 for all). They also had fewer tests (eg, sonograms, blood tests) and treatments (eg, antibiotics, intravenous hydration) prior to delivery. During the delivery admission, women in the induction of labor group spent a longer time in labor and delivery (median, 0.83 vs 0.57 days), but both women (P = .002) and their neonates (P < .001) had shorter postpartum stays. Women and neonates in both groups had similar frequencies of postpartum urgent care and hospital readmissions (P > .05 for all).
CONCLUSION


Women randomized to induction of labor had longer durations in labor and delivery but significantly fewer antepartum visits, tests, and treatments and shorter maternal and neonatal hospital durations after delivery. These results demonstrate that the health outcome advantages associated with induction of labor are gained without incurring uniformly greater health care resource use.",2020,"Women and neonates in both groups had similar frequencies of PP urgent care and hospital readmissions (p>0.05 for all).
","['low-risk nulliparous women', '6096 women with data available, those in the IOL group (n = 3059']","['labor induction versus expectant management', 'planned elective labor induction']","['antepartum (AP), delivery admission, and discharge through 8 weeks postpartum (PP', 'antepartum hospitalization', 'urgent care', 'PP urgent care and hospital readmissions', 'unanticipated care', 'longer time in labor and delivery', 'shorter maternal and neonatal hospital durations post-delivery', 'shorter postpartum stays', 'longer durations in labor and delivery']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C2585455', 'cui_str': 'Expectant management (procedure)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0456336', 'cui_str': 'Antepartum (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}]",,0.11091,"Women and neonates in both groups had similar frequencies of PP urgent care and hospital readmissions (p>0.05 for all).
","[{'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Departments of Obstetrics and Gynecology, Northwestern University, Chicago, IL. Electronic address: w-grobman@northwestern.edu.'}, {'ForeName': 'Grecio', 'Initials': 'G', 'LastName': 'Sandoval', 'Affiliation': 'George Washington University Biostatistics Center, Washington, DC.'}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'University of Utah Health Sciences Center, Salt Lake City, UT.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': 'Departments of Obstetrics and Gynecology, Northwestern University, Chicago, IL.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'University of Utah Health Sciences Center, Salt Lake City, UT.'}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': 'George Washington University Biostatistics Center, Washington, DC.'}, {'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': 'Stanford University, Stanford, CA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': 'Columbia University, New York, NY.'}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': 'Brown University, Providence, RI.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ""University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, TX.""}, {'ForeName': 'Jay D', 'Initials': 'JD', 'LastName': 'Iams', 'Affiliation': 'Ohio State University, Columbus, OH.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': 'MetroHealth Medical Center-Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Gibbs', 'Affiliation': 'University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Duke University, Durham, NC.'}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Washington University, Saint Louis, MO.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.01.002']
646,31852769,"Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study.","OBJECTIVE


Faecal microbiota transplantation (FMT) from healthy donors to patients with irritable bowel syndrome (IBS) has been attempted in two previous double-blind, placebo-controlled studies. While one of those studies found improvement of the IBS symptoms, the other found no effect. The present study was conducted to clarify these contradictory findings.
DESIGN


This randomised, double-blind, placebo-controlled study randomised 165 patients with IBS to placebo (own faeces), 30 g FMT or 60 g FMT at a ratio of 1:1:1. The material for FMT was obtained from one healthy, well-characterised donor, frozen and administered via gastroscope. The primary outcome was a reduction in the IBS symptoms at 3 months after FMT (response). A response was defined as a decrease of 50 or more points in the total IBS symptom score. The secondary outcome was a reduction in the dysbiosis index (DI) and a change in the intestinal bacterial profile, analysed by 16S rRNA gene sequencing, at 1 month following FMT.
RESULTS


Responses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively. These were accompanied by significant improvements in fatigue and the quality of life in patients who received FMT. The intestinal bacterial profiles changed also significantly in the groups received FMT. The FMT adverse events were mild self-limiting gastrointestinal symptoms.
CONCLUSIONS


FMT is an effective treatment for patients with IBS. Utilising a well-defined donor with a normal DI and favourable specific microbial signature is essential for successful FMT. The response to FMT increases with the dose.  Trial registration  www.clinicaltrials.gov (NCT03822299) and www.cristin.no (ID657402).",2020,"RESULTS


Responses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively.","['patients with IBS', 'patients with irritable bowel syndrome', '165 patients with IBS to placebo (own faeces), 30\u2009g FMT or 60\u2009g FMT at a ratio of 1:1:1', 'healthy donors to patients with irritable bowel syndrome (IBS']","['faecal microbiota transplantation', 'FMT', 'placebo', 'Faecal microbiota transplantation (FMT', 'www.cristin.no']","['IBS symptoms', 'reduction in the dysbiosis index (DI) and a change in the intestinal bacterial profile, analysed by 16S rRNA gene sequencing', 'intestinal bacterial profiles', 'fatigue and the quality of life', 'total IBS symptom score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3658208', 'cui_str': 'Disbiosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0035899', 'cui_str': 'Ribosomal RNA Genes'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",165.0,0.430062,"RESULTS


Responses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively.","[{'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'El-Salhy', 'Affiliation': 'Stord Hospital, Stord, Norway magdy.elsalhy@sklbb.no.'}, {'ForeName': 'Jan Gunnar', 'Initials': 'JG', 'LastName': 'Hatlebakk', 'Affiliation': 'Department of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.'}, {'ForeName': 'Odd Helge', 'Initials': 'OH', 'LastName': 'Gilja', 'Affiliation': 'Department of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Bråthen Kristoffersen', 'Affiliation': 'Genetic Analysis As, Oslo, Norway.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Hausken', 'Affiliation': 'Department of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.'}]",Gut,['10.1136/gutjnl-2019-319630']
647,32119803,"Biochemical, Anthropometric, and Physiological Responses to Carbohydrate-Restricted Diets Versus a Low-Fat Diet in Obese Adults: A Randomized Crossover Trial.","Some research supports high-fat carbohydrate (CHO)-restricted diets for weight and fat loss and improvement of cardiovascular disease risk factors. To test this, a randomized crossover study was designed. Subjects (17 obese men and women [BMI: 30-38 kg/m 2 ]) were fed three diets (supplying 1600 and 2200 kilocalories (kcal)/day for women and men, respectively) for 4 weeks, with each trial separated by 4-week washout periods. One CHO-restricted diet (10% CHO, 50% fat, and 40% protein content) was rich in plant foods and mushrooms, while the other CHO-restricted diet included more animal foods (10% CHO, 60% fat, and 30% protein content). The third diet was lower in fat and protein content (LF) and higher in CHOs (61% CHO, 21% fat, and 18% protein content). Body composition was assessed through hydrostatic weighing before and after each diet trial. Fasting blood samples were collected weekly for analysis of hormones and lipids. Data were analyzed through repeated measures analysis of variance with  post hoc  paired comparison  t -tests. Weight and fat loss were similar ( P  > .05) among trials. Subjects lost lean mass ( P  < .05) during CHO-restricted trials, but not in the LF trial. Insulin concentrations decreased ( P  < .05) during the CHO-restricted trial and tended ( P  = .05) to decrease during the LF trial. Total cholesterol decreased ( P  < .05) for all trials; however, high-density lipoprotein cholesterol decreased ( P  < .05) and triacylglycerols were higher ( P  < .05) following the LF trial. Taken together, energy restriction regardless of diet composition promoted similar weight loss; however, CHO-restricted diets based on either plants/mushrooms or animal foods elicited a more beneficial lipid-altering effect in comparison with the LF diet.",2020,"Total cholesterol decreased ( P  < .05) for all trials; however, high-density lipoprotein cholesterol decreased ( P  < .05) and triacylglycerols were higher ( P  < .05) following the LF trial.","['Obese Adults', 'Subjects (17 obese men and women [BMI: 30-38\u2009kg/m 2 ']","['fed three diets (supplying 1600 and 2200 kilocalories (kcal)/day', 'Carbohydrate-Restricted Diets Versus a Low-Fat Diet']","['high-density lipoprotein cholesterol', 'fat and protein content (LF) and higher in CHOs', 'triacylglycerols', 'Total cholesterol', 'Fasting blood samples', 'Body composition', 'Weight and fat loss', 'Insulin concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C4517651', 'cui_str': 'Two thousand two hundred'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",17.0,0.043574,"Total cholesterol decreased ( P  < .05) for all trials; however, high-density lipoprotein cholesterol decreased ( P  < .05) and triacylglycerols were higher ( P  < .05) following the LF trial.","[{'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Petrisko', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kloss', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bradley', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Birrenkott', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Spindler', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Clayton', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kern', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, California, USA.'}]",Journal of medicinal food,['10.1089/jmf.2019.0266']
648,32272776,"Protein-Bound Uremic Toxins in Hemodialysis Patients Relate to Residual Kidney Function, Are Not Influenced by Convective Transport, and Do Not Relate to Outcome.","Protein-bound uremic toxins (PBUTs) are predominantly excreted by renal tubular secretion and hardly removed by traditional hemodialysis (HD). Accumulation of PBUTs is proposed to contribute to the increased morbidity and mortality of patients with end-stage kidney disease (ESKD). Preserved PBUT excretion in patients with residual kidney function (RKF) and/or increased PBUT clearance with improved dialysis techniques might improve the prognosis of patients with ESKD. The aims of this study are to explore determinants of PBUTs in HD patients, and investigate whether hemodiafiltration (HDF) lowers PBUT plasma concentrations, and whether PBUTs are related to the outcome. Predialysis total plasma concentrations of kynurenine, kynurenic acid, indoxyl sulfate, indole-3-acetic acid, p-cresyl sulfate, p-cresyl glucuronide, and hippuric acid were measured by UHPLC-MS at baseline and after 6 months of follow-up in the first 80 patients participating in the CONvective TRAnsport Study (CONTRAST), a randomized controlled trial that compared the effects of online HDF versus low-flux HD on all-cause mortality and new cardiovascular events. RKF was inversely related to kynurenic acid ( p  < 0.001), indoxyl sulfate ( p  = 0.001), indole-3-acetic acid ( p  = 0.024), p-cresyl glucuronide ( p  = 0.004) and hippuric acid ( p  < 0.001) plasma concentrations. Only indoxyl sulfate decreased by 8.0% (-15.3 to 34.6) in patients treated with HDF and increased by 11.9% (-15.4 to 31.9) in HD patients after 6 months of follow-up (HDF vs. HD:  p  = 0.045). No independent associations were found between PBUT plasma concentrations and either risk of all-cause mortality or new cardiovascular events. In summary, in the current population, RKF is an important determinant of PBUT plasma concentrations in HD patients. The addition of convective transport did not consistently decrease PBUT plasma concentrations and no relation was found between PBUTs and cardiovascular endpoints.",2020,"RKF was inversely related to kynurenic acid ( p  < 0.001), indoxyl sulfate ( p  = 0.001), indole-3-acetic acid ( p  = 0.024), p-cresyl glucuronide ( p  = 0.004) and hippuric acid ( p  < 0.001) plasma concentrations.","['HD patients', 'patients with residual kidney function (RKF', 'patients with end-stage kidney disease (ESKD']","['hemodiafiltration (HDF', 'online HDF versus low-flux HD']","['indoxyl sulfate', 'hippuric acid', 'Residual Kidney Function', 'kynurenic acid', 'indole-3-acetic acid', 'PBUT plasma concentrations and either risk of all-cause mortality or new cardiovascular events', 'Predialysis total plasma concentrations of kynurenine, kynurenic acid, indoxyl sulfate, indole-3-acetic acid, p-cresyl sulfate, p-cresyl glucuronide, and hippuric acid', 'RKF', 'PBUT plasma concentrations']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}]","[{'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0021210', 'cui_str': 'Indican'}, {'cui': 'C0062725', 'cui_str': 'Hippuric acid'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0022816', 'cui_str': 'Kynurenic acid'}, {'cui': 'C0936060', 'cui_str': 'Indoleacetic acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022818', 'cui_str': 'Kynurenine'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}]",80.0,0.0181568,"RKF was inversely related to kynurenic acid ( p  < 0.001), indoxyl sulfate ( p  = 0.001), indole-3-acetic acid ( p  = 0.024), p-cresyl glucuronide ( p  = 0.004) and hippuric acid ( p  < 0.001) plasma concentrations.","[{'ForeName': 'Maaike K', 'Initials': 'MK', 'LastName': 'van Gelder', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, 3584 CX Utrecht, The Netherlands.'}, {'ForeName': 'Igor R', 'Initials': 'IR', 'LastName': 'Middel', 'Affiliation': 'Division of Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, 3584 CG Utrecht, The Netherlands.'}, {'ForeName': 'Robin W M', 'Initials': 'RWM', 'LastName': 'Vernooij', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, 3584 CX Utrecht, The Netherlands.'}, {'ForeName': 'Michiel L', 'Initials': 'ML', 'LastName': 'Bots', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Utrecht, 3584 CG Utrecht, The Netherlands.'}, {'ForeName': 'Marianne C', 'Initials': 'MC', 'LastName': 'Verhaar', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, 3584 CX Utrecht, The Netherlands.'}, {'ForeName': 'Rosalinde', 'Initials': 'R', 'LastName': 'Masereeuw', 'Affiliation': 'Division of Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, 3584 CG Utrecht, The Netherlands.'}, {'ForeName': 'Muriel P', 'Initials': 'MP', 'LastName': 'Grooteman', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Nephrology, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Menso J', 'Initials': 'MJ', 'LastName': 'Nubé', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Nephrology, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'van den Dorpel', 'Affiliation': 'Department of Internal Medicine, Maasstad Hospital, 3079 DZ Rotterdam, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Blankestijn', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, 3584 CX Utrecht, The Netherlands.'}, {'ForeName': 'Maarten B', 'Initials': 'MB', 'LastName': 'Rookmaaker', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, 3584 CX Utrecht, The Netherlands.'}, {'ForeName': 'Karin G F', 'Initials': 'KGF', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center Utrecht, 3584 CX Utrecht, The Netherlands.'}]",Toxins,['10.3390/toxins12040234']
649,32272653,"Leisure-Time Physical Activity, Sedentary Behaviour and Diet Quality are Associated with Metabolic Syndrome Severity: The PREDIMED-Plus Study.","Healthy lifestyle factors, such as physical activity (PA) and Mediterranean diet (MD), decrease the likelihood of developing metabolic syndrome (MetS). The aim of this study was to report main lifestyle components and related factors according to the MetS severity. Cross-sectional analysis was done of baseline lifestyle factors from 5739 participants with overweight/obesity and MetS features (aged 55-75 years) included in the PREDIMED-PLUS primary cardiovascular prevention randomized trial. Participants were categorized in tertiles according to a validated MetS severity score (MetSSS). Anthropometrics, visceral adiposity index, dietary nutrient intake, biochemical marker levels, as well as a Dietary Inflammatory Index and depression symptoms (Beck Depression Inventory-II) were measured. Diet quality was assessed using a 17-item energy-restricted MD questionnaire. Duration and intensity of PA was self-reported using the Minnesota-REGICOR Short Physical Activity Questionnaire. Sedentary behaviours were measured using the Spanish version of the Nurses' Health Study questionnaire. The 30 s chair stand test was also assessed. Participants with highest MetSSS showed higher values of cardiovascular risk factors (except for total cholesterol and LDL cholesterol), depression risk, sedentary and TV viewing time, and lower moderate and vigorous leisure-time physical activity (LTPA). Highest MetSSS participants tended to a pro-inflammatory dietary pattern and tended to lower MD adherence. In addition, they showed lower carbohydrate and nut intake and higher intake of protein, saturated and trans fatty acids, cholesterol, iodine, sodium, red and processed meat products, other oils different from olive oil and spirit alcoholic drinks. The highest MetS severity score was associated with lower moderate and vigorous LTPA and higher sedentary time and depression risk, as they tended to a pro-inflammatory dietary pattern and lower MD adherence.",2020,"Participants with highest MetSSS showed higher values of cardiovascular risk factors (except for total cholesterol and LDL cholesterol), depression risk, sedentary and TV viewing time, and lower moderate and vigorous leisure-time physical activity (LTPA).",['5739 participants with overweight/obesity and MetS features (aged 55-75 years'],[],"['sedentary time and depression risk', 'Diet quality', 'Leisure-Time Physical Activity, Sedentary Behaviour and Diet Quality', 'physical activity (PA) and Mediterranean diet (MD), decrease the likelihood of developing metabolic syndrome (MetS', 'Sedentary behaviours', 'lower carbohydrate and nut intake and higher intake of protein, saturated and trans fatty acids, cholesterol, iodine, sodium, red and processed meat products', 'total cholesterol and LDL cholesterol), depression risk, sedentary and TV viewing time, and lower moderate and vigorous leisure-time physical activity (LTPA', 'Duration and intensity of PA', 'cardiovascular risk factors', 'validated MetS severity score (MetSSS', 'Anthropometrics, visceral adiposity index, dietary nutrient intake, biochemical marker levels, as well as a Dietary Inflammatory Index and depression symptoms (Beck Depression Inventory-II', 'highest MetS severity score', 'MD adherence']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0452956', 'cui_str': 'Processed meat'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",5739.0,0.0274326,"Participants with highest MetSSS showed higher values of cardiovascular risk factors (except for total cholesterol and LDL cholesterol), depression risk, sedentary and TV viewing time, and lower moderate and vigorous leisure-time physical activity (LTPA).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gallardo-Alfaro', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Maria Del Mar', 'Initials': 'MDM', 'LastName': 'Bibiloni', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Catalina M', 'Initials': 'CM', 'LastName': 'Mascaró', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Montemayor', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ruiz-Canela', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Romaguera', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vioque', 'Affiliation': 'Nutritional Epidemiology Unit, Miguel Hernández University, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), 46020 Alicante, Spain.'}, {'ForeName': 'Ángel M', 'Initials': 'ÁM', 'LastName': 'Alonso-Gómez', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wärnberg', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Fernández-García', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García Ríos', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Bueno-Cavanillas', 'Affiliation': 'CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'José J', 'Initials': 'JJ', 'LastName': 'Gaforio', 'Affiliation': 'CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Matía-Martín', 'Affiliation': 'Department of Endocrinology and Nutrition, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Daimiel', 'Affiliation': 'Nutritional Genomics and Epigenomics Group, IMDEA Food, CEI UAM + CSIC, 28049 Madrid, Spain.'}, {'ForeName': 'Rafael M', 'Initials': 'RM', 'LastName': 'Micó-Pérez', 'Affiliation': 'CIBER Diabetes y Enfermedades Metabólicas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Vidal', 'Affiliation': 'Department of Endocrinology, IDIBAPS, Hospital Clinic, University of Barcelona, 08036 Barcelona, Spain.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Vázquez', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Cesar Ignacio', 'Initials': 'CI', 'LastName': 'Fernandez-Lázaro', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Becerra-Tomás', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Ignacio Manuel', 'Initials': 'IM', 'LastName': 'Gimenez-Alba', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'María Dolors', 'Initials': 'MD', 'LastName': 'Zomeño', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Jadwiga', 'Initials': 'J', 'LastName': 'Konieczna', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Compañ-Gabucio', 'Affiliation': 'Nutritional Epidemiology Unit, Miguel Hernández University, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), 46020 Alicante, Spain.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Tojal-Sierra', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Jéssica', 'Initials': 'J', 'LastName': 'Pérez-López', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'M Ángeles', 'Initials': 'MÁ', 'LastName': 'Zulet', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Casañas-Quintana', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Castro-Barquero', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Gómez-Pérez', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Santos-Lozano', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Galera', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'Basterra-Gortari', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Basora', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Saiz', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Karla Alejandra', 'Initials': 'KA', 'LastName': 'Pérez-Vega', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Aina M', 'Initials': 'AM', 'LastName': 'Galmés-Panadés', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Tercero-Maciá', 'Affiliation': 'Centro de Salud Raval, 03203 Elche, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Sorto-Sánchez', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Sayón-Orea', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'García-Gavilán', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Júlia', 'Initials': 'J', 'LastName': 'Muñoz-Martínez', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Josep A', 'Initials': 'JA', 'LastName': 'Tur', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}]",Nutrients,['10.3390/nu12041013']
650,32189446,Simulation in Urological Training and Education (SIMULATE): Protocol and curriculum development of the first multicentre international randomized controlled trial assessing the transferability of simulation-based surgical training.,"OBJECTIVES


To report the study protocol for the first international multicentre randomized controlled trial investigating the effectiveness of simulation-based surgical training and the development process for an evidence-based training curriculum, to be delivered as an educational intervention.
PARTICIPANTS AND METHODS


This prospective, international, multicentre randomized controlled clinical and educational trial will recruit urology surgical trainees who must not have performed ≥10 of the selected index procedure, ureterorenoscopy (URS). Participants will be randomized to simulation-based training (SBT) or non-simulation-based training (NSBT), the latter of which is the current sole standard of training globally. The primary outcome is the number of procedures required to achieve proficiency, where proficiency is defined as achieving a learning curve plateau of 28 or more on an Objective Structured Assessment of Technical Skills (OSATS) assessment scale, for three consecutive operations, without any complications. All participants will be followed up either until they complete 25 procedures or for 18 months. Development of the URS SBT curriculum took place through a two-round Delphi process.
RESULTS


A total of 47 respondents, consisting of trainees (n = 24) with URS experience and urolithiasis specialists (n = 23), participated in round 1 of the Delphi process. Specialists (n = 10) finalized the content of the curriculum in round 2. The developed interventional curriculum consists of initial theoretic knowledge through didactic lectures followed by select tasks and cases on the URO-Mentor (Simbionix, Lod, Israel) VR Simulator, Uro-Scopic Trainer (Limbs & Things, Bristol, UK) and Scope Trainer (Mediskills, Manchester, UK) models for both semi-rigid and flexible URS. Respondents also selected relevant non-technical skills scenarios and cadaveric simulation tasks as additional components, with delivery subject to local availability.
CONCLUSIONS


SIMULATE is the first multicentre trial investigating the effect and transferability of supplementary SBT on operating performance and patient outcomes. An evidence-based training curriculum is presented, developed with expert and trainee input. Participants will be followed and the primary outcome, number of procedures required to proficiency, will be reported alongside key clinical secondary outcomes, (ISCRTN 12260261).",2020,"Participants will be randomised to simulation-based training (SBT) or non-simulation-based training (NSBT), the latter of which is the current sole standard of training globally.","['47 respondents consisting of trainees (n=24), with URS experience, and urolithiasis specialists (n=23) participated in round-1 of the Delphi process', 'Surgery', 'urology surgical trainees who must not have performed ≥ 10 of the selected index procedure, ureterorenoscopy (URS']","['Transferability of Simulation-based Training', 'simulation-based surgical training', 'simulation-based training (SBT) or non-simulation-based training (NSBT']","['number of procedures required to achieve proficiency, where proficiency is defined as achieving a learning curve plateau of 28 or more on an Objective Structured Assessment of Technical Skill (OSATS) assessment scale, on 3 consecutive operations, without any complications']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0451641', 'cui_str': 'Urinary Lithiasis'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1270970', 'cui_str': 'Ureterorenoscopy (procedure)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C2936637', 'cui_str': 'Learning Curve'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.182342,"Participants will be randomised to simulation-based training (SBT) or non-simulation-based training (NSBT), the latter of which is the current sole standard of training globally.","[{'ForeName': 'Abdullatif', 'Initials': 'A', 'LastName': 'Aydin', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Van Hemelrijck', 'Affiliation': ""School of Cancer and Pharmaceutical Studies, King's College London, London, UK.""}, {'ForeName': 'Hashim U', 'Initials': 'HU', 'LastName': 'Ahmed', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, UK.'}, {'ForeName': 'Muhammad Shamim', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': 'Prokar', 'Initials': 'P', 'LastName': 'Dasgupta', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJU international,['10.1111/bju.15056']
651,32271710,Safety/Efficacy of New Topical Silicone Formulation with Selective Growth Factors for Treating Striae Distensae.,"Striae distensae (SD) are linear dermal scars that arise from progressive stretching or tearing of the dermal layer. This study tests the safety and efficacy of a topical formulation of silicone-based scar cream containing selective synthetic recombinant human growth factors, hyaluronic acid, and vitamin C to improve overall appearance and texture of SD. Twenty-two subjects with SD alba were recruited and randomized to apply the topical formula to half of their SD laterally twice a day for 1 month. Patient surveys were obtained at 1 month for overall appearance, texture, and tolerability. Three-dimensional imaging was obtained at baseline and at 1 month and submitted to independent evaluators for grading on overall appearance. Subjects reported improved texture and appearance in 86.4% of SD. Subjects reported 100% of untreated SD to have no change in overall appearance or texture. 90.9% of subjects reported no tolerability issues. 9.1% of the treated group reported mild issues such as slight itching or redness the first day of application, which subsided in 2 days for all patients. Independent evaluators indicated improvement in 72.7% of SD in comparison to improvement in 36.3% of untreated SD. This study demonstrates that the investigated topical formulation is safe and effective to use for SD.",2020,Independent evaluators indicated improvement in 72.7% of SD in comparison to improvement in 36.3% of untreated SD.,['Twenty-two subjects with SD alba'],"['silicone-based scar cream containing selective synthetic recombinant human growth factors, hyaluronic acid, and vitamin C', 'New Topical Silicone Formulation']","['overall appearance and texture of SD', 'overall appearance, texture, and tolerability', 'slight itching or redness', 'safety and efficacy', 'overall appearance or texture', 'texture and appearance']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0152459', 'cui_str': 'Linear atrophy'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0152459', 'cui_str': 'Linear atrophy'}, {'cui': 'C2937276', 'cui_str': 'Slight'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0286139,Independent evaluators indicated improvement in 72.7% of SD in comparison to improvement in 36.3% of untreated SD.,"[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Kikuchi', 'Affiliation': 'Aesthetic and Reconstructive Oculoplastic Surgery, Beverly Hills, California 90212 (R.K., A.W., B.K., C.I.Z.), Department of Plastic Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California 90033 (E.M.W.), Division of Applied Statistics, Victoria University of Wellington, Wellington, New Zealand 6140 (V.P.).'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Waldman', 'Affiliation': 'Aesthetic and Reconstructive Oculoplastic Surgery, Beverly Hills, California 90212 (R.K., A.W., B.K., C.I.Z.), Department of Plastic Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California 90033 (E.M.W.), Division of Applied Statistics, Victoria University of Wellington, Wellington, New Zealand 6140 (V.P.).'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'Wolfswinkel', 'Affiliation': 'Aesthetic and Reconstructive Oculoplastic Surgery, Beverly Hills, California 90212 (R.K., A.W., B.K., C.I.Z.), Department of Plastic Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California 90033 (E.M.W.), Division of Applied Statistics, Victoria University of Wellington, Wellington, New Zealand 6140 (V.P.).'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Pletzer', 'Affiliation': 'Aesthetic and Reconstructive Oculoplastic Surgery, Beverly Hills, California 90212 (R.K., A.W., B.K., C.I.Z.), Department of Plastic Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California 90033 (E.M.W.), Division of Applied Statistics, Victoria University of Wellington, Wellington, New Zealand 6140 (V.P.).'}, {'ForeName': 'Brandon D', 'Initials': 'BD', 'LastName': 'Kalasho', 'Affiliation': 'Aesthetic and Reconstructive Oculoplastic Surgery, Beverly Hills, California 90212 (R.K., A.W., B.K., C.I.Z.), Department of Plastic Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California 90033 (E.M.W.), Division of Applied Statistics, Victoria University of Wellington, Wellington, New Zealand 6140 (V.P.).'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Zoumalan', 'Affiliation': 'Aesthetic and Reconstructive Oculoplastic Surgery, Beverly Hills, California 90212 (R.K., A.W., B.K., C.I.Z.), Department of Plastic Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California 90033 (E.M.W.), Division of Applied Statistics, Victoria University of Wellington, Wellington, New Zealand 6140 (V.P.).'}]",Journal of cosmetic science,[]
652,31780003,Using a cultural dance program to increase sustainable physical activity for breast cancer survivors-A pilot study.,"BACKGROUND


Studies have shown that physical activity can reduce the risk of mortality for female breast cancer patients and improve quality of life, reduce weight, and alter circulating biomarker levels. We conducted a pilot trial to determine the feasibility of increasing physical activity through a cultural dance intervention to achieve similar benefits.
METHODS


Conducted a pilot trial implementing a cultural dance intervention to increase and sustain physical activity for breast cancer survivors, which consisted of a six-month group-based intervention of Hula Dance. Anthropometric measures, fasting blood draws, and self-reported questionnaires to assess physical activity, mood, and quality of life, were completed at baseline, at the end of the 6-month intervention (time point month-6), and at two additional post-intervention time points (month-12 and month-24) to assess sustainability.
RESULTS


A total of 11 women with a median age of 63 years were enrolled in the intervention trial. Eight of the 11 (73%) completed the trial to month-12 and demonstrated an overall significant increase in weekly moderate exercise. There were no significant changes in intra-individual body mass index (BMI). However, there was a sustained post-intervention reduction in waist circumference and significant changes in circulating biomarker levels. For the self-reported measures, there was a significant increase in vigor/activity (p < 0.001; Profile of Mood States-Short Form).
CONCLUSION


Our intervention pilot trial demonstrated that a cultural dance program could achieve a sustainable increase in physical activity for breast cancer survivors, with potential to improve quality of life, increase vigor, and decrease levels of circulating cytokines associated with obesity and inflammation.",2019,"For the self-reported measures, there was a significant increase in vigor/activity (p < 0.001;","['breast cancer survivors', '11 women with a median age of 63 years', 'female breast cancer patients']","['cultural dance program', 'cultural dance intervention']","['vigor/activity', 'circulating biomarker levels', 'weekly moderate exercise', 'physical activity', 'sustainable physical activity', 'quality of life, increase vigor', 'intra-individual body mass index (BMI', 'waist circumference', 'Anthropometric measures, fasting blood draws, and self-reported questionnaires to assess physical activity, mood, and quality of life']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0205695,"For the self-reported measures, there was a significant increase in vigor/activity (p < 0.001;","[{'ForeName': 'Lenora W M', 'Initials': 'LWM', 'LastName': 'Loo', 'Affiliation': 'University of Hawaii Cancer Center, Population Sciences in the Pacific Program, 701 Ilalo Street, Honolulu, HI, 96813, United States. Electronic address: lloo@cc.hawaii.edu.'}, {'ForeName': 'Kryslin', 'Initials': 'K', 'LastName': 'Nishibun', 'Affiliation': 'University of Hawaii Cancer Center, Population Sciences in the Pacific Program, 701 Ilalo Street, Honolulu, HI, 96813, United States.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Welsh', 'Affiliation': 'University of Hawaii Cancer Center, Population Sciences in the Pacific Program, 701 Ilalo Street, Honolulu, HI, 96813, United States.'}, {'ForeName': 'TeMoana', 'Initials': 'T', 'LastName': 'Makolo', 'Affiliation': 'University of Hawaii Cancer Center, Population Sciences in the Pacific Program, 701 Ilalo Street, Honolulu, HI, 96813, United States.'}, {'ForeName': 'Clayton D', 'Initials': 'CD', 'LastName': 'Chong', 'Affiliation': ""The Queen's Medical Center, Queen's Cancer Center, 1301 Punchbowl Street, Honolulu, HI, 96813, United States.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Pagano', 'Affiliation': 'University of Hawaii Cancer Center, Population Sciences in the Pacific Program, 701 Ilalo Street, Honolulu, HI, 96813, United States.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'University of Hawaii Cancer Center, Population Sciences in the Pacific Program, 701 Ilalo Street, Honolulu, HI, 96813, United States.'}, {'ForeName': 'Erin O', 'Initials': 'EO', 'LastName': 'Bantum', 'Affiliation': 'University of Hawaii Cancer Center, Population Sciences in the Pacific Program, 701 Ilalo Street, Honolulu, HI, 96813, United States.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2019.102197']
653,32272750,"Intracoronary Injection of Autologous CD34+ Cells Improves One-Year Left Ventricular Systolic Function in Patients with Diffuse Coronary Artery Disease and Preserved Cardiac Performance-A Randomized, Open-Label, Controlled Phase II Clinical Trial.","This phase II randomized controlled trial tested whether intracoronary autologous CD34+ cell therapy could further improve left ventricular (LV) systolic function in patients with diffuse coronary artery disease (CAD) with relatively preserved LV ejection fraction (defined as LVEF >40%) unsuitable for coronary intervention. Between December 2013 and November 2017, 60 consecutive patients were randomly allocated into group 1 (CD34+ cells, 3.0 × 10 7 /vessel/ n  = 30) and group 2 (optimal medical therapy;  n  = 30). All patients were followed for one year, and preclinical and clinical parameters were compared between two groups. Three-dimensional echocardiography demonstrated no significant difference in LVEF between groups 1 and 2 (54.9% vs. 51.0%, respectively,  p  = 0.295) at 12 months. However, compared with baseline, 12-month LVEF was significantly increased in group 1 ( p  < 0.001) but not in group 2 ( p  = 0.297). From baseline, there were gradual increases in LVEF in group 1 compared to those in group 2 at 1-month, 3-months, 6-months and 12 months (+1.6%, +2.2%, +2.9% and +4.6% in the group 1 vs. -1.6%, -1.5%, -1.4% and -0.9% in the group 2; all  p  < 0.05). Additionally, one-year angiogenesis (2.8 ± 0.9 vs. 1.3 ± 1.1), angina (0.4 ± 0.8 vs. 1.8 ± 0.9) and HF (0.7 ± 0.8 vs. 1.8 ± 0.6) scores were significantly improved in group 1 compared to those in group 2 (all  p  < 0.001). In conclusion, autologous CD34+ cell therapy gradually and effectively improved LV systolic function in patients with diffuse CAD and preserved LVEF who were non-candidates for coronary intervention (Trial registration: ISRCTN26002902 on the website of ISRCTN registry).",2020,"However, compared with baseline, 12-month LVEF was significantly increased in group 1 ( p  < 0.001) but not in group 2 ( p  = 0.297).","['patients with diffuse CAD', 'Between December 2013 and November 2017, 60 consecutive patients', 'Patients with Diffuse Coronary Artery Disease and Preserved Cardiac Performance', 'patients with diffuse coronary artery disease (CAD) with relatively preserved LV ejection fraction (defined as LVEF >40%) unsuitable for coronary intervention']","['intracoronary autologous CD34+ cell therapy', 'Intracoronary Injection of Autologous CD34+ Cells', 'autologous CD34+ cell therapy']","['LVEF', 'gradual increases in LVEF', 'LV systolic function', '12-month LVEF', 'left ventricular (LV) systolic function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",60.0,0.037202,"However, compared with baseline, 12-month LVEF was significantly increased in group 1 ( p  < 0.001) but not in group 2 ( p  = 0.297).","[{'ForeName': 'Pei-Hsun', 'Initials': 'PH', 'LastName': 'Sung', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung 83301, Taiwan.'}, {'ForeName': 'Yi-Chen', 'Initials': 'YC', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung 83301, Taiwan.'}, {'ForeName': 'Mel S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedics, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung 83301, Taiwan..'}, {'ForeName': 'Hao-Yi', 'Initials': 'HY', 'LastName': 'Hsiao', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung 83301, Taiwan.'}, {'ForeName': 'Ming-Chun', 'Initials': 'MC', 'LastName': 'Ma', 'Affiliation': 'Division of Hema-Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 83301, Taiwan.'}, {'ForeName': 'Sung-Nan', 'Initials': 'SN', 'LastName': 'Pei', 'Affiliation': 'Department of Hematology Oncology, E-Da Cancer Hospital and I-Shou University, College of Medicine, Kaohsiung 82445, Taiwan.'}, {'ForeName': 'Hsin-Ju', 'Initials': 'HJ', 'LastName': 'Chiang', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 83301, Taiwan.'}, {'ForeName': 'Fan-Yen', 'Initials': 'FY', 'LastName': 'Lee', 'Affiliation': 'Division of Thoracic and Cardiovascular Surgery, Department of Surgery, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 83301, Taiwan.'}, {'ForeName': 'Hon-Kan', 'Initials': 'HK', 'LastName': 'Yip', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung 83301, Taiwan.'}]",Journal of clinical medicine,['10.3390/jcm9041043']
654,32272758,"Yoga and Mindfulness as a Tool for Influencing Affectivity, Anxiety, Mental Health, and Stress among Healthcare Workers: Results of a Single-Arm Clinical Trial.","Mindfulness-based interventions have emerged as unique approaches for addressing a range of clinical and subclinical difficulties such as stress, chronic pain, anxiety, or recurrent depression. Moreover, there is strong evidence about the positive effects of yoga practice on stress management and prevention of burnout among healthcare workers. The aim of this study was to conduct a single-arm clinical trial to assess the effectiveness of an intervention based on mindfulness-based stress reduction and yoga in improving healthcare workers' quality of life. Healthcare workers of two hospitals in Rome were enrolled in a 4-week yoga and mindfulness course. Four questionnaires were administered at different times (Short Form-12 (SF-12), State-Trait Anxiety Inventory (STAI) Y1 and Y2, and Positive and Negative Affect Schedule (PANAS)) to evaluate the efficacy of the intervention. Forty participants took part to the study (83.3 %). The Mental Composite Score-12, that is part of the quality of life assessment, passed from a median of 43.5 preintervention to 48.1 postintervention ( p  = 0.041), and the negative affect passed from a score of 16 in the preintervention to 10 in the postintervention ( p  < 0.001). Both the forms of the STAI questionnaires showed a decrease after the intervention. Yoga and mindfulness administered together seem to be effective to reduce stress and anxiety in healthcare workers, providing them with more consciousness and ability to manage work stressful demands.",2020,Both the forms of the STAI questionnaires showed a decrease after the intervention.,"['Healthcare workers of two hospitals in Rome were enrolled in a 4-week yoga and mindfulness course', 'Forty participants took part to the study (83.3 ', 'Healthcare Workers']",['intervention based on mindfulness-based stress reduction and yoga'],"['Short Form-12 (SF-12), State-Trait Anxiety Inventory (STAI) Y1 and Y2, and Positive and Negative Affect Schedule (PANAS', ""healthcare workers' quality of life""]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",40.0,0.0479725,Both the forms of the STAI questionnaires showed a decrease after the intervention.,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'La Torre', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Raffone', 'Affiliation': 'Department of Psychology, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Peruzzo', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychology, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Rosario Andrea', 'Initials': 'RA', 'LastName': 'Cocchiara', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': ""D'Egidio"", 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Pasquale Fabio', 'Initials': 'PF', 'LastName': 'Leggieri', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Dorelli', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Zaffina', 'Affiliation': ""Occupational Medicine, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.""}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Mannocci', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Yomin Collaborative Group', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}]",Journal of clinical medicine,['10.3390/jcm9041037']
655,32035124,Protocol paper: Stepped wedge cluster randomized trial translating the ABCS into optimizing cardiovascular care for people living with HIV.,"People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts. The ABCS (aspirin-blood pressure control-cholesterol control-smoking cessation) reduce atherosclerotic (ASCVD) risk in the general population, but little is known regarding strategies for promoting the ABCS among PWH. Guided by the Consolidated Framework for Implementation Research (CFIR), we designed multilevel implementation strategies that target PWH and their clinicians to promote appropriate use of the ABCS based on a 10-year estimated ASCVD risk. Implementation strategies include patient coaching, automated texting, peer phone support, academic detailing and audit and feedback for the patient's clinician. We are evaluating implementation through a stepped wedge cluster randomized trial based on the Reach-Effectiveness-Adoption-Maintenance/Qualitative-Evaluation-for-Systematic-Translation (RE-AIM/QuEST) mixed methods framework that integrates quantitative and qualitative assessments. The primary outcome is change in ASCVD risk. Findings will have important implications regarding strategies for reducing ASCVD risk among PWH.",2020,People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts.,"['people living with HIV', 'People living with HIV (PWH']","['ABCS (aspirin-blood pressure control-cholesterol control-smoking cessation', 'ABCS']",['change in ASCVD risk'],"[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0702008,People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts.,"[{'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Williams', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Johnson', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Tobin', 'Affiliation': 'Clinical Directors Network (CDN), Community-Engaged Research, The Rockefeller University Center for Clinical and Translational Science, New York, NY.'}, {'ForeName': 'Amneris Esther', 'Initials': 'AE', 'LastName': 'Luque', 'Affiliation': 'Infectious Diseases and Geographic Medicine, HIV Program at Parkland Health and Hospital System, Community Prevention and Intervention Unit, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Mechelle', 'Initials': 'M', 'LastName': 'Sanders', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Carroll', 'Affiliation': 'Department of Family Medicine, University of Colorado, Aurora, CO.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cassells', 'Affiliation': 'Clinical Directors Network, Inc. (CDN), New York, NY.'}, {'ForeName': 'Tameir', 'Initials': 'T', 'LastName': 'Holder', 'Affiliation': 'Clinical Directors Network, Inc. (CDN), New York, NY.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fiscella', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, NY. Electronic address: Kevin_fiscella@urmc.rochester.edu.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.02.003']
656,32272827,Dental caries and periodontal status in children with type 1 diabetes mellitus.,"INTRODUCTION


Type 1 diabetes mellitus (T1DM) is a chronic metabolic disease that strongly affects the health of individuals. Some studies have sug-gested that it affects oral health, thus indicating a higher-than-average predisposition of patients with diabetes to caries and periodontal diseases.
AIM OF THE STUDY


We aimed at investigating the association between caries, periodontal diseases, and diabetes among children using dental indices.
MATERIAL AND METHODS


The study included 50 children (aged 10-18 years) who had type 1 diabetes for at least years. The participants were divided into well controlled (WC), (HBA1c < 7.5%) and poorly controlled (PC) (HBA1c ≥ 7.5%) groups (25 diabetic children each). The control group (GC) included non-diabetic children. The following clinical parameters were measured: DMFT index, plaque index (PI), approximal plaque index (API), gingival index (GI), and modified sulcus bleeding index (mSBI).
RESULTS


The WC group had the lowest average value - 3.44 of the DMFT index with values of 5.80 and 3.88 in the PC and GC groups, respec-tively. A statistically significant difference was found in the DMFT value between PC and WC groups (p = 0.04). No statistically signif-icant differences in the values of other indices were found between the groups.
CONCLUSIONS


Children with poorly controlled type 1 diabetes were characterised by a significantly higher intensity of caries. In contrast, no statistical-ly significant differences were observed in the periodontal status between the study groups.",2020,A statistically significant difference was found in the DMFT value between PC and WC groups (p = 0.04).,"['children using dental indices', 'children with type 1 diabetes mellitus', '50 children (aged 10-18 years) who had type 1 diabetes for at least years']",[],"['DMFT value', 'Dental caries and periodontal status', 'periodontal status', 'DMFT index, plaque index (PI), approximal plaque index (API), gingival index (GI), and modified sulcus bleeding index (mSBI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]",[],"[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",50.0,0.0201685,A statistically significant difference was found in the DMFT value between PC and WC groups (p = 0.04).,"[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Pachoński', 'Affiliation': 'NZOZ Pachońscy Dental Clinic, Tarnowskie Gory, Poland.'}, {'ForeName': 'Przemysława', 'Initials': 'P', 'LastName': 'Jarosz-Chobot', 'Affiliation': ""Department of Children's Diabetology, Medical University of Silesia, Katowice, Poland.""}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Koczor-Rozmus', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Patrycja', 'Initials': 'P', 'LastName': 'Łanowy', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Mocny-Pachońska', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Medical University of Silesia, Katowice, Poland.'}]","Pediatric endocrinology, diabetes, and metabolism",['10.5114/pedm.2020.93249']
657,32268554,"Effects of Age on Acute Appetite-Related Responses to Whey-Protein Drinks, Including Energy Intake, Gastric Emptying, Blood Glucose, and Plasma Gut Hormone Concentrations-A Randomized Controlled Trial.","Protein-rich supplements are used commonly to increase energy intake in undernourished older people. This study aimed to establish age effects on energy intake, appetite, gastric emptying, blood glucose, and gut hormones in response to protein-rich drinks. In a randomized double-blind, order, 13 older men (age: 75 ± 2 yrs, body mass index (BMI): 26 ± 1 kg/m 2 ) and 13 younger (23 ± 1 yrs, 24 ± 1 kg/m 2 ) men consumed (i) a control drink (~2 kcal) or drinks (450 mL) containing protein/fat/carbohydrate: (ii) 70 g/0 g/0 g (280 kcal/'P 280' ), (iii) 14 g/12.4 g/28 g (280 kcal/'M 280' ), (iv) 70 g/12.4 g/28 g (504 kcal/'M 504' ), on four separate days. Appetite (visual analog scales), gastric emptying (3D ultrasonography), blood glucose, plasma insulin, ghrelin, cholecystokinin (CCK), glucagon-like peptide-1 (GLP-1) concentrations (0-180 min), and ad-libitum energy intake (180-210 min) were determined. Older men, compared to younger men, had higher fasting glucose and CCK concentrations and lower fasting GLP-1 concentrations (all  p  < 0.05). Energy intake by P 280  compared to control was less suppressed in older men (increase: 49 ± 42 kcal) than it was in younger men (suppression: 100 ± 54 kcal,  p  = 0.038). After the caloric drinks, the suppression of hunger and the desire to eat, and the stimulation of fullness was less ( p  < 0.05), and the stimulation of plasma GLP-1 was higher ( p  < 0.05) in older men compared to younger men. Gastric emptying, glucose, insulin, ghrelin, and CCK responses were similar between age groups. In conclusion, ageing reduces the responses of caloric drinks on hunger, the desire to eat, fullness, and energy intake, and protein-rich nutrition supplements may be an effective strategy to increase energy intake in undernourished older people.",2020,Energy intake by P 280  compared to control was less suppressed in older men (increase: 49 ± 42 kcal) than it was in younger men,"['older men (increase: 49 ± 42 kcal) than it was in younger men', 'Older men', '13 older men (age: 75 ± 2 yrs, body mass index (BMI): 26 ± 1 kg/m 2 ) and 13 younger (23 ± 1 yrs, 24 ± 1 kg/m 2 ) men consumed (i) a', 'undernourished older people']","['Protein-rich supplements', 'control drink ', 'drinks (450 mL) containing protein/fat/carbohydrate: (ii) 70']","['Gastric emptying, glucose, insulin, ghrelin, and CCK responses', 'hunger, the desire to eat, fullness, and energy intake', 'suppression of hunger and the desire to eat, and the stimulation of fullness', 'Energy Intake, Gastric Emptying, Blood Glucose, and Plasma Gut Hormone Concentrations', 'stimulation of plasma GLP-1', 'energy intake, appetite, gastric emptying, blood glucose, and gut hormones', 'Energy intake', 'Appetite (visual analog scales), gastric emptying (3D ultrasonography), blood glucose, plasma insulin, ghrelin, cholecystokinin (CCK), glucagon-like peptide-1', 'fasting glucose and CCK concentrations and lower fasting GLP-1 concentrations']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",13.0,0.0743672,Energy intake by P 280  compared to control was less suppressed in older men (increase: 49 ± 42 kcal) than it was in younger men,"[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Giezenaar', 'Affiliation': 'Riddet Institute, Massey University, Palmerston North 4474, New Zealand.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence (C.R.E.) in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia 5000, Australia.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Hausken', 'Affiliation': 'Department of Medicine, Haukeland University Hospital, 5021 Bergen, Norway.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence (C.R.E.) in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia 5000, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence (C.R.E.) in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia 5000, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chapman', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence (C.R.E.) in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia 5000, Australia.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Soenen', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence (C.R.E.) in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Royal Adelaide Hospital, South-Australia 5000, Australia.'}]",Nutrients,['10.3390/nu12041008']
658,32268604,Extracellular Vesicle Biomarkers Reveal Inhibition of Neuroinflammation by Infliximab in Association with Antidepressant Response in Adults with Bipolar Depression.,"Accumulating evidence suggests that neuroinflammation is involved in bipolar disorder (BD) pathogenesis. The tumor necrosis factor-alpha (TNF-α) antagonist infliximab was recently reported to improve depressive symptoms in a subpopulation of individuals with BD and history of childhood maltreatment. To explore the mechanistic mediators of infliximab's effects, we investigated its engagement with biomarkers of cellular response to inflammation derived from plasma extracellular vesicles enriched for neuronal origin (NEVs). We hypothesized that infliximab, compared to placebo, would decrease TNF-α receptors (TNFRs) and nuclear factor-kappa B (NF-κB) pathway signaling biomarkers, and that history of childhood abuse would moderate infliximab's effects. We immunocaptured NEVs from plasma samples collected at baseline and at weeks 2, 6, and 12 (endpoint) from 55 participants of this clinical trial and measured NEV biomarkers using immunoassays. A subset of participants ( n  = 27) also underwent whole-brain magnetic resonance imaging at baseline and endpoint. Childhood physical abuse moderated treatment by time interactions for TNFR1 (χ 2  = 9.275,  p  = 0.026), NF-κB (χ 2  = 13.825,  p  = 0.003), and inhibitor of NF-κB (IκBα) (χ 2  = 7.990,  p  = 0.046), indicating that higher levels of physical abuse were associated with larger biomarker decreases over time. Moreover, the antidepressant response to infliximab was moderated by TNFR1 (χ 2  = 7.997,  p  = 0.046). In infliximab-treated participants, reductions in TNFR1 levels were associated with improvement of depressive symptoms, an effect not detected in the placebo group. Conversely, reductions in TNFR1 levels were associated with increased global cortical thickness in infliximab- (r = -0.581,  p  = 0.029), but not placebo-treated, patients (r = 0.196,  p  = 0.501). In conclusion, we report that NEVs revealed that infliximab engaged the TNFR/NF-κB neuro-inflammatory pathway in individuals with BD, in a childhood trauma-dependent manner, which was associated with clinical response and brain structural changes.",2020,"Childhood physical abuse moderated treatment by time interactions for TNFR1 (χ 2  = 9.275,  p  = 0.026), NF-κB (χ 2  = 13.825,  ",['Adults with Bipolar Depression'],"['infliximab', 'placebo']","['TNFR1 levels', 'global cortical thickness', 'inhibitor of NF-κB (IκBα)\uf061', 'depressive symptoms', 'TNF-α receptors (TNFRs) and nuclear factor-kappa B (NF-κB) pathway signaling biomarkers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0255808', 'cui_str': 'Lymphocyte antigen CD120A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C0037080', 'cui_str': 'Signal Pathways'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",55.0,0.172907,"Childhood physical abuse moderated treatment by time interactions for TNFR1 (χ 2  = 9.275,  p  = 0.026), NF-κB (χ 2  = 13.825,  ","[{'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Francheska', 'Initials': 'F', 'LastName': 'Delgado-Peraza', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD 20892, USA.'}, {'ForeName': 'Mehala', 'Initials': 'M', 'LastName': 'Subramaniapillai', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Iacobucci', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Rodrigues', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Rosenblat', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA 94304, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA 94304, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA 94304, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Raison', 'Affiliation': 'School of Human Ecology, University of Wisconsin-Madison, Madison, WI 53706, USA.'}, {'ForeName': 'Sahil', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD 20892, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Nogueras-Ortiz', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD 20892, USA.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kapogiannis', 'Affiliation': 'Laboratory of Clinical Investigation, Intramural Research Program, National Institute on Aging, National Institutes of Health (NIA/NIH), Baltimore, MD 20892, USA.'}]",Cells,['10.3390/cells9040895']
659,32268550,Glutamatergic Activation of Neuronostatin Neurons in the Periventricular Nucleus of the Hypothalamus.,"Neuronostatin, a newly identified anorexigenic peptide, is present in the central nervous system. We tested the hypothesis that neuronostatin neurons are activated by feeding as a peripheral factor and that the glutamatergic system has regulatory influences on neuronostatin neurons. The first set of experiments analyzed the activation of neuronostatin neurons by refeeding as a physiological stimulus and the effectiveness of the glutamatergic system on this physiological stimulation. The subjects were randomly divided into three groups: the fasting group, refeeding group, and 6-cyano-7-nitroquinoxaline-2,3-dione (CNQX)+refeeding group. We found that refeeding increased the phosphorylated signal transducers and transcription activator-5 (pSTAT5) expression in neuronostatin-positive neurons and that the CNQX injection significantly suppressed the number of pSTAT5-expressing neuronostatin neurons. The second set of experiments analyzed the activation pathways of neuronostatin neurons and the regulating effects of the glutamatergic system on neuronostatin neurons. The animals received intraperitoneal injections of glutamate receptor agonists (kainic acid, α-amino-3-hydroxy-5methyl-4-isoazepropionic acid (AMPA), and N-methyl-D-aspartate (NMDA)) or 0.9% NaCl. The number of c-Fos-expressing neuronostatin neurons significantly increased following the AMPA and NMDA injections. In conclusion, we found that the neuronostatin neurons were activated by peripheral or central signals, including food intake and/or glutamatergic innervation, and that the glutamate receptors played an important role in this activation.",2020,We found that refeeding increased the phosphorylated signal transducers and transcription activator-5 (pSTAT5) expression in neuronostatin-positive neurons and that the CNQX injection significantly suppressed the number of pSTAT5-expressing neuronostatin neurons.,[],"['fasting group, refeeding group, and 6-cyano-7-nitroquinoxaline-2,3-dione (CNQX)+refeeding group', 'intraperitoneal injections of glutamate receptor agonists (kainic acid, α-amino-3-hydroxy-5methyl-4-isoazepropionic acid (AMPA), and N-methyl-D-aspartate (NMDA)) or 0.9% NaCl']",['number of c-Fos-expressing neuronostatin neurons'],[],"[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0099122', 'cui_str': '6-Cyano-2,3-dihydroxy-7-nitroquinoxaline'}, {'cui': 'C0021493', 'cui_str': 'Intraperitoneal injection'}, {'cui': 'C0061465', 'cui_str': 'Glutamate Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0022471', 'cui_str': 'Digenic Acid'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0085301', 'cui_str': 'c-fos Proteins'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0027882', 'cui_str': 'Neuron'}]",,0.0128451,We found that refeeding increased the phosphorylated signal transducers and transcription activator-5 (pSTAT5) expression in neuronostatin-positive neurons and that the CNQX injection significantly suppressed the number of pSTAT5-expressing neuronostatin neurons.,"[{'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Serter Kocoglu', 'Affiliation': 'Department of Histology and Embryology, Balikesir University School of Medicine, 10145 Balikesir, Turkey.'}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Gok Yurtseven', 'Affiliation': 'Department of Histology and Embryology, Sanko University School of Medicine, 27090 Gaziantep, Turkey.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Cakir', 'Affiliation': 'Department of Histology and Embryology, Bursa Uludag University School of Medicine, 16240 Bursa, Turkey.'}, {'ForeName': 'Zehra', 'Initials': 'Z', 'LastName': 'Minbay', 'Affiliation': 'Department of Histology and Embryology, Bursa Uludag University School of Medicine, 16240 Bursa, Turkey.'}, {'ForeName': 'Ozhan', 'Initials': 'O', 'LastName': 'Eyigor', 'Affiliation': 'Department of Histology and Embryology, Bursa Uludag University School of Medicine, 16240 Bursa, Turkey.'}]",Brain sciences,['10.3390/brainsci10040217']
660,30925125,"Addition of Docetaxel to Oral Fluoropyrimidine Improves Efficacy in Patients With Stage III Gastric Cancer: Interim Analysis of JACCRO GC-07, a Randomized Controlled Trial.","PURPOSE


S-1 is a standard postoperative adjuvant chemotherapy for patients with stage II or III gastric cancer in Asia. Neoadjuvant or perioperative strategies dominate in Western countries, and docetaxel has recently shown significant survival benefits when combined with other standard regimens in advanced cancer and perioperative settings.
PATIENTS AND METHODS


This randomized phase III study was designed to prove the superiority of postoperative S-1 plus docetaxel over S-1 alone for R0 resection of pathologic stage III gastric cancer. The sample size of 1,100 patients was necessary to detect a 7% increase in 3-year relapse-free survival as the primary end point (hazard ratio, 0.78; 2-sided α = .05; β = .2).
RESULTS


The second interim analysis was conducted when the number of events reached 216 among 915 enrolled patients (median follow-up, 12.5 months). Analysis demonstrated the superiority of S-1 plus docetaxel (66%) to S-1 (50%) for 3-year relapse-free survival (hazard ratio, 0.632; 99.99% CI, 0.400 to 0.998; stratified log-rank test,  P  < .001), and enrollment was terminated as recommended by the independent data and safety monitoring committee. Incidences of grade 3 or greater adverse events, particularly neutropenia and leukopenia, were higher in the S-1 plus docetaxel group, but all events were manageable.
CONCLUSION


Addition of docetaxel to S-1 is effective with few safety concerns in patients with stage III gastric cancer. The present findings may also be applicable in countries in which perioperative adjuvant chemotherapy or chemoradiation is not standard.",2019,"Incidences of grade 3 or greater adverse events, particularly neutropenia and leukopenia, were higher in the S-1 plus docetaxel group, but all events were manageable.
","['R0 resection of pathologic stage III gastric cancer', 'patients with stage II or III gastric cancer in Asia', 'Patients With Stage III Gastric Cancer', 'patients with stage III gastric cancer']","['S-1 plus docetaxel', 'docetaxel', 'postoperative S-1 plus docetaxel', 'S-1 alone', 'Docetaxel to Oral Fluoropyrimidine']","['Incidences of grade 3 or greater adverse events, particularly neutropenia and leukopenia', 'survival benefits', '3-year relapse-free survival']","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1320480', 'cui_str': 'Pathologic stage'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]","[{'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",915.0,0.14033,"Incidences of grade 3 or greater adverse events, particularly neutropenia and leukopenia, were higher in the S-1 plus docetaxel group, but all events were manageable.
","[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': '1 Gifu University, Gifu, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kodera', 'Affiliation': '2 Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Kochi', 'Affiliation': '3 Nihon University Itabashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Ichikawa', 'Affiliation': '4 Showa University Fujigaoka Hospital, Yokohama, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kakeji', 'Affiliation': '5 Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sano', 'Affiliation': '6 Cancer Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Narutoshi', 'Initials': 'N', 'LastName': 'Nagao', 'Affiliation': '7 Gifu Prefectural General Medical Center, Gifu, Japan.'}, {'ForeName': 'Masazumi', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': ""8 Yokohama Municipal Citizen's Hospital, Yokohama, Japan.""}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Takagane', 'Affiliation': '9 Hakodate Goryoukaku Hospital, Hakodate, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': '10 Konan Kosei Hospital, Konan, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Kaji', 'Affiliation': '11 Toyama Prefectural Central Hospital, Toyama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Okitsu', 'Affiliation': '12 Tokushima Red Cross Hospital, Komatsushima, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nomura', 'Affiliation': '13 Yamagata Prefectural Central Hospital, Yamagata, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Matsui', 'Affiliation': '14 Aichi Cancer Center Aichi Hospital, Okazaki, Japan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': '15 Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Matsuyama', 'Affiliation': '16 Yao Municipal Hospital, Yao, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': '17 Gifu Municipal Hospital, Gifu, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': '18 Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Takeuchi', 'Affiliation': '19 Kitasato University, Tokyo, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Fujii', 'Affiliation': '3 Nihon University Itabashi Hospital, Tokyo, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01138']
661,30860948,Effect of Chemotherapy With Docetaxel With Androgen Suppression and Radiotherapy for Localized High-Risk Prostate Cancer: The Randomized Phase III NRG Oncology RTOG 0521 Trial.,"PURPOSE


Radiotherapy (RT) plus long-term androgen suppression (AS) are a standard treatment option for patients with high-risk localized prostate cancer. We hypothesized that docetaxel chemotherapy (CT) could improve overall survival (OS) and clinical outcomes among patients with high-risk prostate cancer.
PATIENTS AND METHODS


The multicenter randomized NRG Oncology RTOG 0521 study enrolled patients with high-risk nonmetastatic disease between 2005 and 2009. Patients were randomly assigned to receive standard long-term AS plus RT with or without adjuvant CT.
RESULTS


A total of 612 patients were enrolled; 563 were evaluable. Median prostate-specific antigen was 15.1 ng/mL; 53% had a Gleason score 9 to 10 cancer; 27% had cT3 to cT4 disease. Median follow-up was 5.7 years. Treatment was well tolerated in both arms. Four-year OS rate was 89% (95% CI, 84% to 92%) for AS + RT and 93% (95% CI, 90% to 96%) for AS + RT + CT (hazard ratio [HR], 0.69; 90% CI, 0.49 to 0.97; one-sided  P  = .034). There were 59 deaths in the AS + RT arm and 43 in the AS + RT + CT arm, with fewer deaths resulting from prostate cancer in the AS + RT + CT arm versus AS + RT (23  v  16 deaths, respectively). Six-year rate of distant metastasis was 14% for AS + RT and 9.1% for AS + RT + CT, (HR, 0.60; 95% CI, 0.37 to 0.99; two-sided  P  = .044). Six-year disease-free survival rate was 55% for AS + RT and 65% for AS + RT + CT (HR, 0.76; 95% CI, 0.58 to 0.99; two-sided  P  = .043).
CONCLUSION


For patients with high-risk nonmetastatic prostate cancer, CT with docetaxel improved OS from 89% to 93% at 4 years, with improved disease-free survival and reduction in the rate of distant metastasis. The trial suggests that docetaxel CT may be an option to be discussed with selected men with high-risk prostate cancer.",2019,"Six-year disease-free survival rate was 55% for AS + RT and 65% for AS + RT + CT (HR, 0.76; 95% CI, 0.58 to 0.99; two-sided  P  = .043).
","['A total of 612 patients were enrolled; 563 were evaluable', '0521 study enrolled patients with high-risk nonmetastatic disease between 2005 and 2009', 'selected men with high-risk prostate cancer', 'Localized High-Risk Prostate Cancer', 'patients with high-risk localized prostate cancer', 'patients with high-risk prostate cancer']","['Chemotherapy With Docetaxel With Androgen Suppression and Radiotherapy', 'docetaxel', 'AS + RT + CT', 'docetaxel chemotherapy (CT', 'standard long-term AS plus RT with or without adjuvant CT', 'Radiotherapy (RT) plus long-term androgen suppression (AS', 'docetaxel CT']","['tolerated', 'overall survival (OS) and clinical outcomes', 'Six-year disease-free survival rate', 'Median prostate-specific antigen', 'Six-year rate of distant metastasis', 'OS rate']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517834', 'cui_str': '612 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1269798', 'cui_str': 'pM category'}]",612.0,0.103851,"Six-year disease-free survival rate was 55% for AS + RT and 65% for AS + RT + CT (HR, 0.76; 95% CI, 0.58 to 0.99; two-sided  P  = .043).
","[{'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Rosenthal', 'Affiliation': '1 Sutter Medical Group and Sutter Cancer Centers, Sacramento, CA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': '2 NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': '4 Tulane University Health Services Center, New Orleans, LA.'}, {'ForeName': 'Leonard G', 'Initials': 'LG', 'LastName': 'Gomella', 'Affiliation': '5 Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Mahul B', 'Initials': 'MB', 'LastName': 'Amin', 'Affiliation': '6 Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Purdy', 'Affiliation': '7 University of California Davis Medical Center, Sacramento, CA.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Michalski', 'Affiliation': '8 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Garzotto', 'Affiliation': '9 Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Pervez', 'Affiliation': '10 Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Balogh', 'Affiliation': '11 Tom Baker Cancer Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Rodrigues', 'Affiliation': '12 London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Souhami', 'Affiliation': '13 McGill University, Montréal, Quebec, Canada.'}, {'ForeName': 'M Neil', 'Initials': 'MN', 'LastName': 'Reaume', 'Affiliation': '14 The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Williams', 'Affiliation': '15 Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Raquibul', 'Initials': 'R', 'LastName': 'Hannan', 'Affiliation': '16 University of Texas Southwestern Medical School, Dallas, TX.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Horwitz', 'Affiliation': '17 Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': '18 Christiana Care Health Services Community Clinical Oncology Program, Newark, DE.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Peters', 'Affiliation': '19 Northeast Radiation Oncology Center, Dunmore, PA.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': '20 University of California at San Francisco, San Francisco, CA.'}, {'ForeName': 'William U', 'Initials': 'WU', 'LastName': 'Shipley', 'Affiliation': '21 Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': '6 Cedars-Sinai Medical Center, Los Angeles, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02158']
662,30865548,Mutational Analysis of Patients With Colorectal Cancer in CALGB/SWOG 80405 Identifies New Roles of Microsatellite Instability and Tumor Mutational Burden for Patient Outcome.,"PURPOSE


CALGB/SWOG 80405 was a randomized phase III trial that found no statistically significant difference in overall survival (OS) in patients with first-line metastatic colorectal cancer treated with chemotherapy plus either bevacizumab or cetuximab. Primary tumor DNA from 843 patients has been used to discover genetic markers of OS.
PATIENTS AND METHODS


Gene mutations were determined by polymerase chain reaction. Microsatellite status was determined by genotyping of microsatellites. Tumor mutational burden (TMB) was determined by next-generation sequencing. Cox proportional hazard models were used, with adjusting factors. Interaction of molecular alterations with either the bevacizumab or the cetuximab arms was tested.
RESULTS


Patients with high TMB in their tumors had longer OS than did patients with low TMB (hazard ratio [HR], 0.73 [95% CI, 0.57 to 0.95];  P  = .02). In patients with microsatellite instability-high (MSI-H) tumors, longer OS was observed in the bevacizumab arm than in the cetuximab arm (HR, 0.13 [95% CI, 0.06 to 0.30]; interaction  P  < .001 for interaction between microsatellite status and the two arms). Patients with  BRAF  mutant tumors had shorter OS than did patients with wild-type (WT) tumors (HR, 2.01 [95% CI, 1.49 to 2.71];  P  < .001). Patients with extended  RAS  mutant tumors had shorter OS than did patients with WT tumors (HR, 1.52 [95% CI, 1.26 to 1.84];  P  < .001). Patients with triple-negative tumors (WT for  NRAS / KRAS / BRAF ) had a median OS of 35.9 months (95% CI, 33.0 to 38.8 months) versus 22.2 months (95% CI, 19.6 to 24.4 months ) in patients with at least one mutated gene in their tumors ( P  < .001).
CONCLUSION


In patients with metastatic colorectal cancer treated in first line, low TMB, and  BRAF  and  RAS  mutations are negative prognostic factors. Patients with MSI-H tumors benefited more from bevacizumab than from cetuximab, and studies to confirm this effect of MSI-H are warranted.",2019,"In patients with microsatellite instability-high (MSI-H) tumors, longer OS was observed in the bevacizumab arm than in the cetuximab arm (HR, 0.13","['Patients with MSI-H tumors', 'patients with metastatic colorectal cancer', '843 patients', 'Patients with  BRAF', 'Patients With Colorectal Cancer in CALGB/SWOG 80405', 'patients with first-line metastatic colorectal cancer treated with']","['bevacizumab', 'chemotherapy plus either bevacizumab or cetuximab']","['longer OS', 'Tumor mutational burden (TMB', 'median OS', 'shorter OS', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0725974,"In patients with microsatellite instability-high (MSI-H) tumors, longer OS was observed in the bevacizumab arm than in the cetuximab arm (HR, 0.13","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': '1 University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': '2 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Xueping', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': '3 Genentech, South San Francisco, CA.'}, {'ForeName': 'Tyler J', 'Initials': 'TJ', 'LastName': 'Zemla', 'Affiliation': '2 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': '4 Duke University, Durham, NC.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Tam', 'Affiliation': '3 Genentech, South San Francisco, CA.'}, {'ForeName': 'Shilpi', 'Initials': 'S', 'LastName': 'Mahajan', 'Affiliation': '3 Genentech, South San Francisco, CA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': '5 West Virginia University Cancer Institute, Morgantown, WV.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Bertagnolli', 'Affiliation': '6 Dana-Farber/Partners CancerCare, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': '7 Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Sanoff', 'Affiliation': '1 University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Atkins', 'Affiliation': '8 Southeast Clinical Oncology Research Consortium, Winston-Salem, NC.'}, {'ForeName': 'Blasé', 'Initials': 'B', 'LastName': 'Polite', 'Affiliation': '9 University of Chicago Comprehensive Cancer Center, Chicago, IL.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': '10 University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': '11 USC Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Kabbarah', 'Affiliation': '3 Genentech, South San Francisco, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01798']
663,30925126,"Self-Management in Long-Term Prostate Cancer Survivors: A Randomized, Controlled Trial.","PURPOSE


This randomized clinical trial compared a personally tailored, automated telephone symptom management intervention to improve self-management among long-term survivors of prostate cancer with usual care enhanced with a nontailored newsletter about symptom management. We hypothesized that intervention-group participants would have more confident symptom self-management and reduced symptom burden.
METHODS


A total of 556 prostate cancer survivors who, more than 1 year after treatment, were experiencing symptom burden were recruited from April 2015 to February 2017 across four Veterans Affairs sites. Participants were randomly assigned to intervention (n = 278) or usual care (n = 278) groups. We compared differences in the primary (symptom burden according to Expanded Prostate Cancer Index Composite-26 [EPIC], confidence in self-management) and secondary outcomes between groups using intent-to-treat analyses. We compared domain-specific changes in symptom burden from baseline to 5 and 12 months among the intervention group according to the primary symptom focus area (urinary, bowel, sexual, general) of participants.
RESULTS


Most of the prostate cancer survivors in this study were married (54.3%), were white (69.2%), were retired (62.4%), and underwent radiation therapy (56.7%  v  46.2% who underwent surgery), and the mean age was 67 years. There were no baseline differences in urinary, bowel, sexual, or hormonal domain EPIC scores across groups. We observed higher EPIC scores in the intervention arm in all domain areas at 5 months, though differences were not statistically significant. No differences were found in secondary outcomes; however, coping appraisal was higher (2.8  v  2.6;  P  = .02) in intervention-arm patients at 5 months. In subgroup analyses, intervention participants reported improvement from baseline at 5 and 12 months in their symptom focus area domains.
CONCLUSION


This intervention was well received among veterans who were long-term survivors of prostate cancer. Although overall outcome differences were not observed across groups, the intervention tailored to symptom area of choice may hold promise to improve associated burden.",2019,"We observed higher EPIC scores in the intervention arm in all domain areas at 5 months, though differences were not statistically significant.","['long-term survivors of prostate cancer with usual care enhanced with a nontailored newsletter about symptom management', 'Long-Term Prostate Cancer Survivors', 'prostate cancer survivors in this study were married (54.3%), were white (69.2%), were retired (62.4%), and underwent radiation therapy (56.7%  v  46.2% who underwent surgery), and the mean age was 67 years', '556 prostate cancer survivors who, more than 1 year after treatment, were experiencing symptom burden were recruited from April 2015 to February 2017 across four Veterans Affairs sites', 'veterans who were long-term survivors of prostate cancer']","['Self-Management', 'telephone symptom management intervention', 'usual care']","['coping appraisal', 'urinary, bowel, sexual, or hormonal domain EPIC scores', 'EPIC scores']","[{'cui': 'C0206193', 'cui_str': 'Long-Term Survivors'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0555047', 'cui_str': 'Married (finding)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0035345', 'cui_str': 'Retirement'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",556.0,0.0861139,"We observed higher EPIC scores in the intervention arm in all domain areas at 5 months, though differences were not statistically significant.","[{'ForeName': 'Ted A', 'Initials': 'TA', 'LastName': 'Skolarus', 'Affiliation': '1 Veterans Affairs Health Services Research and Development Center for Clinical Management Research, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI.'}, {'ForeName': 'Tabitha', 'Initials': 'T', 'LastName': 'Metreger', 'Affiliation': '1 Veterans Affairs Health Services Research and Development Center for Clinical Management Research, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Wittmann', 'Affiliation': '2 University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Soohyun', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': '3 University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC.'}, {'ForeName': 'Hyungjin Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': '1 Veterans Affairs Health Services Research and Development Center for Clinical Management Research, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Grubb', 'Affiliation': '4 Medical University of South Carolina, Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Gingrich', 'Affiliation': '5 Duke University, Durham Veterans Affairs Healthcare System, Durham, NC.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': '6 Case Western Reserve University, Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Piette', 'Affiliation': '1 Veterans Affairs Health Services Research and Development Center for Clinical Management Research, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI.'}, {'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Hawley', 'Affiliation': '1 Veterans Affairs Health Services Research and Development Center for Clinical Management Research, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01770']
664,31202508,Comparative Bioavailability Study of a New Orodispersible Formulation of Ibuprofen Versus Two Existing Oral Tablet Formulations in Healthy Male and Female Volunteers.,"PURPOSE


This study aimed to assess the comparative bioavailability between ibuprofen acid orodispersible tablets (Test product) and ibuprofen acid oral tablets (Reference product).
METHODS


This was a randomized, single-dose, 3-way crossover, open-label, pharmacokinetic study in 36 healthy male and female volunteers. Blood samples were taken periodically over a 12-h period after dosing to derive total plasma ibuprofen and S(+)/R(-) ibuprofen enantiomer pharmacokinetic parameters; safety profile and tolerability were evaluated throughout the study.
FINDINGS


After a single-dose administration of ibuprofen acid oral tablets (2 × 200 mg), the total ibuprofen C max  and AUC 0-t  (geometric least square [LS] mean) for the Test product was 29.4 μg/mL and 100.6 h/μg/mL, respectively, and for the Reference product it was 30.6 μg/mL and 98.7 h/μg/mL. The geometric LS mean Test/Reference ratio 90% CI for both total ibuprofen C max  (90.71-101.77) and AUC 0-t  (98.72-105.23) was contained entirely within the predefined 80.00%-125.00% lower and upper limits; in addition, no statistically significant difference was found in T max  (P = 0.1819) after fasted administration of the Test and Reference products. There were 4 mild treatment emergent adverse events, considered unrelated to the study drug, reported by 2 volunteers during the study; no serious adverse events, no suspected unexpected serious adverse events. and no clinically significant changes in laboratory safety, vital signs, or 12-lead ECG measurements were reported. The enantiomer-specific analysis mirrored that of total ibuprofen, with the C max  and AUC 0-t  LS mean Test/Reference ratio 90% CI for both ibuprofen S(+) and R(-) enantiomers contained entirely within the predetermined 80%-125.00% limits.
IMPLICATIONS


This study found that ibuprofen acid 200 mg orodispersible tablets and ibuprofen acid 200 mg tablets met the regulatory criteria for bioequivalence for AUC 0-t  and C max . Post hoc analysis of ibuprofen both S(+) and R(-) enantiomers mirrored the findings for total ibuprofen. All investigational products were found to be well tolerated. Clinicaltrials.gov identifier: NCT03180879.",2019,"There were 4 mild treatment emergent adverse events, considered unrelated to the study drug, reported by 2 volunteers during the study; no serious adverse events, no suspected unexpected serious adverse events.","['Healthy Male and Female Volunteers', '36 healthy male and female volunteers']","['Ibuprofen', 'ibuprofen acid', 'ibuprofen acid oral tablets', 'ibuprofen acid orodispersible tablets (Test product) and ibuprofen acid oral tablets (Reference product']","['tolerated', 'laboratory safety, vital signs, or 12-lead ECG measurements', 'T max', 'comparative bioavailability', 'serious adverse events']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0993159', 'cui_str': 'Oral Tablet'}, {'cui': 'C2960508', 'cui_str': 'Conventional release orodispersible tablet'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518766'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",36.0,0.0524628,"There were 4 mild treatment emergent adverse events, considered unrelated to the study drug, reported by 2 volunteers during the study; no serious adverse events, no suspected unexpected serious adverse events.","[{'ForeName': 'Dalma', 'Initials': 'D', 'LastName': 'Sugár', 'Affiliation': 'Reckitt Benckiser Health Limited, Slough, United Kingdom.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Francombe', 'Affiliation': 'Simbec Research Ltd, Merthyr Tydfil, United Kingdom.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'da Silva', 'Affiliation': 'Reckitt Benckiser Health Limited, Slough, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hanid', 'Affiliation': 'Reckitt Benckiser Health Limited, Slough, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hutchings', 'Affiliation': 'Simbec Research Ltd, Merthyr Tydfil, United Kingdom. Electronic address: simon.hutchings@simbec.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.04.040']
665,31202506,"Efficacy and Safety of Udenafil for the Treatment of Pulmonary Arterial Hypertension: a Placebo-controlled, Double-blind, Phase IIb Clinical Trial.","PURPOSE


Udenafil is an oral phosphodiesterase-5 inhibitor approved for the treatment of erectile dysfunction. In a multicenter, placebo-controlled, randomized Phase IIa study, the reduction of pulmonary vascular resistance index was greater with a 50-mg baseline dose of udenafil than with the 100-mg dose, the cardiac index did not decrease at most points, and the safety was excellent, suggesting that 50-mg udenafil could be used in a Phase IIb trial.
METHODS


In this 16-week, double-blind, placebo-controlled study, 63 patients with pulmonary arterial hypertension were randomized to receive 50-mg udenafil or a placebo BID. The primary efficacy end point was the 6-min walking distance. The secondary efficacy end points were the Borg dyspnea score and time to clinical worsening. Patients who completed the 16-week study could participate in a long-term extension study.
FINDINGS


In terms of the difference between the baseline and 16-week 6-min walking distance in both groups, the mean placebo-corrected treatment effect was 25 (58) m (P = 0.0873). Among the patients with a history of endothelin receptor antagonist therapy, the treatment effect at week 16 between the udenafil and placebo groups was 34 (60) m (P = 0.0460). However, there were no significant differences in the Borg dyspnea score and time to clinical worsening between groups. The safety profile and adverse effects of udenafil were similar to those of typical phosphodiesterase-5 inhibitors seen in previous studies.
IMPLICATIONS


Udenafil has a favorable safety profile and improves exercise capacity in patients with pulmonary arterial hypertension. ClinicalTrials.gov identifier: NCT01553721.",2019,"The safety profile and adverse effects of udenafil were similar to those of typical phosphodiesterase-5 inhibitors seen in previous studies.
","['Pulmonary Arterial Hypertension', 'patients with pulmonary arterial hypertension', '63 patients with pulmonary arterial hypertension', 'Patients who completed the 16-week study could participate in a long-term extension study']","['50-mg udenafil or a placebo BID', 'placebo', 'Placebo', 'phosphodiesterase-5 inhibitor', 'Udenafil']","['6-min walking distance', 'dyspnea score and time to clinical worsening', 'exercise capacity', 'Efficacy and Safety', 'pulmonary vascular resistance index']","[{'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C1742789', 'cui_str': '3-(1-Methyl-7-oxo-3-propyl-4,7-dihydro-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-N-(2-(1-methyl-2-pyrrolidinyl)ethyl)-4-propoxybenzenesulfonamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C1318700', 'cui_str': 'PDE5 Inhibitors'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456262', 'cui_str': 'Pulmonary vascular resistance index (observable entity)'}]",63.0,0.37042,"The safety profile and adverse effects of udenafil were similar to those of typical phosphodiesterase-5 inhibitors seen in previous studies.
","[{'ForeName': 'Hyuk-Jae', 'Initials': 'HJ', 'LastName': 'Chang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Shinjeong', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-A', 'Initials': 'SA', 'LastName': 'Chang', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyung-Kwan', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Hae-Ok', 'Initials': 'HO', 'LastName': 'Jung', 'Affiliation': ""Cardiovascular Center, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Jung-Hyun', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Pusan National University Hospital, Pusan, South Korea.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kye-Hun', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'The Heart Center of Chonnam National University Hospital, Chonnam National University Research Institute of Medical Sciences, Gwangju, South Korea.'}, {'ForeName': 'Jin-Ok', 'Initials': 'JO', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Cardiovascular Center, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, South Korea.'}, {'ForeName': 'Ju Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, South Korea.'}, {'ForeName': 'Duk-Kyung', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: dukkyung.kim@gmail.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.05.006']
666,31307833,"Efficacy and Safety of a Fixed-Dose Combination of Candesartan and Rosuvastatin on Blood Pressure and Cholesterol in Patients With Hypertension and Hypercholesterolemia: A Multicenter, Randomized, Double-Blind, Parallel Phase III Clinical Study.","PURPOSE


The aim of this study was to evaluate the blood pressure-lowering and cholesterol-lowering effects of a fixed-dose combination therapy using candesartan (CND)/rosuvastatin (RSV) compared with CND or RSV monotherapy in patients with hypertension and hypercholesterolemia.
METHODS


This study was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 394 patients were screened. After a 4-week run-in period, 219 of these patients with hypertension and primary hypercholesterolemia were randomized. Patients received 1 of 3 regimens for 8 weeks: (1) CND 32 mg/RSV 20 mg, (2) RSV 20 mg, or (3) CND 32 mg. The primary outcome variables were changes in the systolic blood pressure (SBP) and diastolic blood pressure (DBP) and the percentage changes in LDL-C from baseline to the drug treatment at 8 weeks. The secondary outcome variables were percentage changes of total cholesterol, triglycerides, HDL-C, non-HDL-C, apolipoprotein B, apolipoprotein A-I, high-sensitivity C-reactive protein, and glucose metabolic indices, including percentage changes of the homeostasis model assessment of insulin resistance (HOMA-IR), adiponectin, and hemoglobin A 1c . Tolerability of combination therapy was compared with other monotherapy groups.
FINDINGS


The percentage changes of LDL-C were -48.6% (from 157.2 to 80.1 mg/dL) in the RSV group and -49.8% (from 160.2 to 78.9 mg/dL) in the CND/RSV group from baseline to the end of 8 weeks of treatment. Mean SBP and DBP were significantly decreased in the CND/RSV and CND groups after 8 weeks (P < 0.001 for all); however, no significant differences were found between the 2 groups. Total cholesterol levels, triglycerides, non-HDL-C, and apolipoprotein B were significantly reduced in the CND/RSV and RSV groups, with no significant differences between the groups compared with the CND group (P < 0.001 for all). The percentage changes of HOMA-IR, adiponectin, and hemoglobin A 1c  had no significant differences between the combination groups and monotherapy groups. However, in a 2-sample t test, HOMA-IR was significantly decreased in the CND/RSV group compared with the RSV group in nondiabetic patients (mean [SD] percentage change of HOMA-IR, -8.7% [37.6%] vs 17.1% [53.1%]; P = 0.048). There were no significant differences in metabolic indices between the diabetic groups. Adverse events in the CND/RSV group were similar to those in the monotherapy group.
IMPLICATIONS


Once-daily fixed-dose combination therapy with CND/RSV is an effective, tolerable, convenient treatment option for patients with essential hypertension and hypercholesteremia. ClinicalTrials.gov identifier: NCT02770261.",2019,"Total cholesterol levels, triglycerides, non-HDL-C, and apolipoprotein B were significantly reduced in the CND/RSV and RSV groups, with no significant differences between the groups compared with the CND group (P < 0.001 for all).","['patients with hypertension and primary hypercholesterolemia', 'Patients With Hypertension and Hypercholesterolemia', '394 patients were screened', 'patients with essential hypertension and hypercholesteremia', 'patients with hypertension and hypercholesterolemia']","['CND', 'CND/RSV', 'RSV', 'placebo', 'CND or RSV monotherapy', 'Candesartan and Rosuvastatin', 'candesartan (CND)/rosuvastatin (RSV', 'combination therapy']","['HOMA-IR, adiponectin, and hemoglobin', 'metabolic indices', 'Mean SBP and DBP', 'percentage changes of LDL-C', 'Adverse events', 'percentage changes of total cholesterol, triglycerides, HDL-C, non-HDL-C, apolipoprotein B, apolipoprotein A-I, high-sensitivity C-reactive protein, and glucose metabolic indices, including percentage changes of the homeostasis model assessment of insulin resistance (HOMA-IR), adiponectin, and hemoglobin A 1c ', 'HOMA-IR', 'Blood Pressure and Cholesterol', 'Tolerability', 'Efficacy and Safety', 'Total cholesterol levels, triglycerides, non-HDL-C, and apolipoprotein B', 'systolic blood pressure (SBP) and diastolic blood pressure (DBP) and the percentage changes in LDL-C', 'blood pressure-lowering and cholesterol-lowering effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0342879', 'cui_str': 'Primary hypercholesterolemia (disorder)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}]","[{'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0717550', 'cui_str': 'candesartan'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0622790', 'cui_str': 'Apo A-I (Giessen)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",394.0,0.0458476,"Total cholesterol levels, triglycerides, non-HDL-C, and apolipoprotein B were significantly reduced in the CND/RSV and RSV groups, with no significant differences between the groups compared with the CND group (P < 0.001 for all).","[{'ForeName': 'Kyoung Im', 'Initials': 'KI', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Bo Hyun', 'Initials': 'BH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Pusan National University Hospital and Biomedical Research Institute, Busan, South Korea.'}, {'ForeName': 'Yong Hyun', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Jeong-Cheon', 'Initials': 'JC', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Korea University Ansan Hospital, Seoul, South Korea.'}, {'ForeName': 'Sang Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul Boramae Hospital, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Wook Jin', 'Initials': 'WJ', 'LastName': 'Chung', 'Affiliation': 'Department of Internal Medicine, Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'Weon', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Il Suk', 'Initials': 'IS', 'LastName': 'Sohn', 'Affiliation': 'Department of Internal Medicine, Kyung Hee University School of Medicine, Kyung Hee University Hospital at Gangdong, Seoul, South Korea.'}, {'ForeName': 'Jin Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yong Jin', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Kiyuk', 'Initials': 'K', 'LastName': 'Chang', 'Affiliation': ""Department of Internal Medicine, The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, South Korea.""}, {'ForeName': 'Cheol Woong', 'Initials': 'CW', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, Korea University Anam Hospital, Seoul, South Korea.'}, {'ForeName': 'Soe Hee', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Ulsan University Hospital, Ulsan, South Korea.'}, {'ForeName': 'Seok Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jae Kean', 'Initials': 'JK', 'LastName': 'Ryu', 'Affiliation': 'Department of Internal Medicine, Daegu Catholic University Hospital, Daegu, South Korea.'}, {'ForeName': 'Jong Young', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Bum Kee', 'Initials': 'BK', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Taek Jong', 'Initials': 'TJ', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Gyu Park', 'Affiliation': 'Department of Internal Medicine, Korea University Guro Hospital, Seoul, South Korea. Electronic address: parkcg@kumc.or.kr.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.05.007']
667,32270891,Effects of High-Intensity Resistance Training on Osteopenia and Sarcopenia Parameters in Older Men with Osteosarcopenia-One-Year Results of the Randomized Controlled Franconian Osteopenia and Sarcopenia Trial (FrOST).,"Dynamic resistance exercise (DRT) might be the most promising agent for fighting sarcopenia in older people. However, the positive effect of DRT on osteopenia/osteoporosis in men has still to be confirmed. To evaluate the effect of low-volume/high-intensity (HIT)-DRT on bone mineral density (BMD) and skeletal muscle mass index (SMI) in men with osteosarcopenia, we initiated the Franconian Osteopenia and Sarcopenia Trial (FrOST). Forty-three sedentary community-dwelling older men (aged 73 to 91 years) with osteopenia/osteoporosis and SMI-based sarcopenia were randomly assigned to a HIT-RT exercise group (EG; n = 21) or a control group (CG; n = 22). HIT-RT provided a progressive, periodized single-set DRT on machines with high intensity, effort, and velocity twice a week, while CG maintained their lifestyle. Both groups were adequately supplemented with whey protein, vitamin D, and calcium. Primary study endpoint was integral lumbar spine (LS) BMD as determined by quantitative computed tomography. Core secondary study endpoint was SMI as determined by dual-energy X-ray absorptiometry. Additional study endpoints were BMD at the total hip and maximum isokinetic hip-/leg-extensor strength (leg press). After 12 months of exercise, LS-BMD was maintained in the EG and decreased significantly in the CG, resulting in significant between-group differences (p < 0.001; standardized mean difference [SMD] = 0.90). In parallel, SMI increased significantly in the EG and decreased significantly in the CG (p < 0.001; SMD = 1.95). Total hip BMD changes did not differ significantly between the groups (p = 0.064; SMD = 0.65), whereas changes in maximum hip-/leg-extensor strength were much more prominent (p < 0.001; SMD = 1.92) in the EG. Considering dropout (n = 2), attendance rate (95%), and unintended side effects/injuries (n = 0), we believe our HIT-RT protocol to be feasible, attractive, and safe. In summary, we conclude that our combined low-threshold HIT-RT/protein/vitamin D/calcium intervention was feasible, safe, and effective for tackling sarcopenia and osteopenia/osteoporosis in older men with osteosarcopenia. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.",2020,"In parallel, SMI increased significantly in the EG and decreased significantly in the CG (p<.001, SMD: 1.95).","['Older Men with Osteosarcopenia - One-year results of the randomized controlled Franconian Osteopenia and Sarcopenia Trial (FrOST', 'older people', 'men with osteosarcopenia, we initiated the Franconian Osteopenia and Sarcopenia Trial', 'older men with osteosarcopenia', 'Forty-three sedentary community dwelling older men (73-91\u2009years) with osteopenia/osteoporosis and SMI-based sarcopenia']","['High Intensity Resistance Training', 'low volume/high intensity (HIT)-DRT', 'HIT-RT exercise', 'Dynamic resistance exercise (DRT', 'whey protein, Vit-D and calcium', 'DRT', 'calcium intervention']","['maximum hip-/leg-extensor strength', 'Total hip BMD changes', 'osteopenia/osteoporosis', 'BMD at the total hip and maximum isokinetic hip-/leg-extensor strength (leg press', 'integral lumbar spine (LS) BMD', 'bone mineral density (BMD) and skeletal muscle mass index (SMI', 'Osteopenia and Sarcopenia parameters', 'attendance rate', 'skeletal muscle mass index (SMI) as determined by dual-energy-x-ray absorptiometry', 'LS-BMD']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3849574', 'cui_str': 'EPHB2 protein, human'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]",43.0,0.0184288,"In parallel, SMI increased significantly in the EG and decreased significantly in the CG (p<.001, SMD: 1.95).","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kemmler', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kohl', 'Affiliation': 'Faculty Medical and Life Sciences, University of Furtwangen, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fröhlich', 'Affiliation': 'Department of Sports Science, University of Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Jakob', 'Affiliation': 'Bernhard-Heine-Center for Locomotion Research, Würzburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Engelke', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'von Stengel', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schoene', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4027']
668,32256159,Three-dimensional assessment of transverse dentoskeletal mandibular dimensions after utilizing two designs of fixed mandibular expansion appliance: A prospective clinical investigation.,"The aim of this clinical study was to evaluate and compare the dentoskeletal transverse mandibular arch dimensions following the use of two designs of fixed mandibular expanders using cone beam computed tomography (CBCT). Twenty orthodontic patients, 12 females and 8 males, with mean age of 13.4 ± 0.5 years were selected and randomly divided into two equivalent groups; group A consisted of 10 patients (4 boys, 6 girls) who were treated with modified Williams expander and group B consisted of 10 patients (4 boys, 6 girls) who were treated with a two-arm fixed expander. Consistent expansion instructions were given to all patients according to a standardized slow protocol of one quarter turn twice/week for both expanders. Routine orthodontic records as well as mandibular CBCTs were obtained before (T1) and immediately after expansion (T2) to estimate changes in dentoskeletal mandibular transverse dimensions. The data was statistically analyzed and the significance level was set at  p  ≤ 0.05. Mandibular intercanine, inter-premolar, intermolar widths; and arch perimeter were significantly increased ( p  ≤ 0.05) following expansion with both fixed expanders. However, the changes in inter-premolar width, intercanine width, and arch perimeter were significantly augmented in two-arm fixed expander group than modified Williams's group. In contrast, their effects on the skeletal mandibular body width were non-significant ( p  > 0.05). Both expanders yielded significant and equivalent dentoalveolar effects that were more evident with two-arm fixed expander than the William one. Both fixed designs enhanced mandibular transverse dental dimensions; however, they were unsuccessful to create any considerable skeletal effects.",2020,Both expanders yielded significant and equivalent dentoalveolar effects that were more evident with two-arm fixed expander than the William one.,"['10 patients (4 boys, 6 girls) who were treated with a two-arm fixed expander', '10 patients (4 boys, 6 girls) who were treated with', 'Twenty orthodontic patients, 12 females and 8 males, with mean age of 13.4\xa0±\xa00.5\xa0years']","['modified Williams expander and group B', 'fixed mandibular expansion appliance', 'fixed mandibular expanders using cone beam computed tomography (CBCT']","['changes in inter-premolar width, intercanine width, and arch perimeter', 'mandibular transverse dental dimensions', 'skeletal mandibular body width']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0222746', 'cui_str': 'Structure of body of mandible'}]",20.0,0.026524,Both expanders yielded significant and equivalent dentoalveolar effects that were more evident with two-arm fixed expander than the William one.,"[{'ForeName': 'Saif-Alnasr Abdullah', 'Initials': 'SA', 'LastName': 'Milad', 'Affiliation': 'Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Farouk Ahmed', 'Initials': 'FA', 'LastName': 'Hussein', 'Affiliation': 'Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Al-DanyAtwa', 'Initials': 'AD', 'LastName': 'Mohammed', 'Affiliation': 'Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Mohamed I', 'Initials': 'MI', 'LastName': 'Hashem', 'Affiliation': 'Dental Biomaterials Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2019.12.008']
669,32241260,"A factorial cluster-randomised controlled trial combining home-environmental and early child development interventions to improve child health and development: rationale, trial design and baseline findings.","BACKGROUND


Exposure to unhealthy environments and inadequate child stimulation are main risk factors that affect children's health and wellbeing in low- and middle-income countries. Interventions that simultaneously address several risk factors at the household level have great potential to reduce these negative effects. We present the design and baseline findings of a cluster-randomised controlled trial to evaluate the impact of an integrated home-environmental intervention package and an early child development programme to improve diarrhoea, acute respiratory infections and childhood developmental outcomes in children under 36 months of age living in resource-limited rural Andean Peru.
METHODS


We collected baseline data on children's developmental performance, health status and demography as well as microbial contamination in drinking water. In a sub-sample of households, we measured indoor kitchen 24-h air concentration levels of carbon monoxide (CO) and fine particulate matter (PM 2.5 ) and CO for personal exposure.
RESULTS


We recruited and randomised 317 children from 40 community-clusters to four study arms. At baseline, all arms had similar health and demographic characteristics, and the developmental status of children was comparable between arms. The analysis revealed that more than 25% of mothers completed primary education, a large proportion of children were stunted and diarrhoea prevalence was above 18%. Fifty-two percent of drinking water samples tested positive for thermo-tolerant coliforms and the occurrence of E.coli was evenly distributed between arms. The mean levels of kitchen PM 2.5  and CO concentrations were 213 μg/m 3  and 4.8 ppm, respectively.
CONCLUSIONS


The trial arms are balanced with respect to most baseline characteristics, such as household air and water pollution, and child development. These results ensure the possible estimation of the trial effectiveness. This trial will yield valuable information for assessing synergic, rational and cost-effective benefits of the combination of home-based interventions.
TRIAL REGISTRY


ISRCTN-26548981.",2020,Fifty-two percent of drinking water samples tested positive for thermo-tolerant coliforms and the occurrence of E.coli was evenly distributed between arms.,"['children under 36\u2009months of age living in resource-limited rural Andean Peru', '317 children from 40 community-clusters to four study arms']","['home-environmental and early child development interventions', 'integrated home-environmental intervention package and an early child development programme']","['mean levels of kitchen PM 2.5  and CO concentrations', 'diarrhoea prevalence', 'diarrhoea, acute respiratory infections and childhood developmental outcomes', 'indoor kitchen 24-h air concentration levels of carbon monoxide (CO) and fine particulate matter (PM 2.5 ) and CO for personal exposure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026118', 'cui_str': 'Environmental intervention'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0557653', 'cui_str': 'Kitchen'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",317.0,0.197468,Fifty-two percent of drinking water samples tested positive for thermo-tolerant coliforms and the occurrence of E.coli was evenly distributed between arms.,"[{'ForeName': 'Stella M', 'Initials': 'SM', 'LastName': 'Hartinger', 'Affiliation': 'Department of Epidemiology & Public Health, Swiss Tropical and Public Health Institute, Basel, Switzerland. stella.hartinger.p@upch.pe.'}, {'ForeName': 'Nestor', 'Initials': 'N', 'LastName': 'Nuño', 'Affiliation': 'Department of Epidemiology & Public Health, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hattendorf', 'Affiliation': 'Department of Epidemiology & Public Health, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Verastegui', 'Affiliation': 'School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Karlen', 'Affiliation': 'Department of Health Sciences and Technology, ETH Zürich, Zürich, Switzerland.'}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Ortiz', 'Affiliation': 'Programa Nacional CUNA MAS, Lima, Peru.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mäusezahl', 'Affiliation': 'Department of Epidemiology & Public Health, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}]",BMC medical research methodology,['10.1186/s12874-020-00950-y']
670,32260508,"Comparison of Clinical Outcomes between Hyaluronic and Polylactic Acid Filler Injections for Penile Augmentation in Men Reporting a Small Penis: A Multicenter, Patient-Blinded/Evaluator-Blinded, Non-Inferiority, Randomized Comparative Trial with 18 Months of Follow-up.","Although several types of penile augmentation (PA) fillers have been recently introduced, no long-term follow-up studies have compared them. This study aimed to compare the long-term clinical outcomes of hyaluronic acid (HA) and polylactic acid (PLA) filler injections for PA. Our multicenter, patient-blinded/evaluator-blinded, randomized comparative trial was performed for 18 months after the single injection of fillers. Sixty-seven healthy men reporting a small penis were administered an injection between November 2016 and May 2017. Subjects were divided into the HA group (n = 33) and PLA group (n = 34). At 18 months, the mean penile girths had significantly increased in both groups (each  p  < 0.001). Changes in the mean penile girth of both groups were not significantly different during the study period. Satisfaction levels at 18 months were significantly higher than those at baseline in both groups (each  p  < 0.01). Changes in satisfaction levels did not differ significantly during the study period. Injection-associated adverse events (AEs) occurred in three (9.1%) patients in the HA group and in two (5.9%) patients in the PLA group; no serious AEs occurred. In conclusion, HA and PLA filler injections for PA led to significant augmentation and increased satisfaction. Clinical efficacy and safety were comparable between groups.",2020,Satisfaction levels at 18 months were significantly higher than those at baseline in both groups (each  p  < 0.01).,"['Sixty-seven healthy men reporting a small penis were administered an injection between November 2016 and May 2017', 'Men Reporting a Small Penis']","['Hyaluronic and Polylactic Acid Filler Injections', 'penile augmentation (PA) fillers', 'hyaluronic acid (HA) and polylactic acid (PLA) filler injections', 'PLA']","['mean penile girth', 'mean penile girths', 'satisfaction', 'Satisfaction levels', 'adverse events (AEs', 'Clinical efficacy and safety', 'satisfaction levels']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0240701', 'cui_str': 'Small penis'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0071443', 'cui_str': 'Polylactic acid'}, {'cui': 'C0729441', 'cui_str': 'Filler'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",67.0,0.152096,Satisfaction levels at 18 months were significantly higher than those at baseline in both groups (each  p  < 0.01).,"[{'ForeName': 'Dae Yul', 'Initials': 'DY', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, College of Medicine, Hallym Unversity, Kangdong Sacred Heart Hospital, Seoul 05355, Korea.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Jeong', 'Affiliation': 'Department of Urology, College of Medicine, Hallym Unversity, Kangdong Sacred Heart Hospital, Seoul 05355, Korea.'}, {'ForeName': 'Kyungtae', 'Initials': 'K', 'LastName': 'Ko', 'Affiliation': 'Department of Urology, College of Medicine, Hallym Unversity, Kangdong Sacred Heart Hospital, Seoul 05355, Korea.'}, {'ForeName': 'Seong Ho', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Hallym Unversity, Dongtan Sacred Heart Hospital, Hwaseong 18450, Korea.'}, {'ForeName': 'Young Goo', 'Initials': 'YG', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Hallym Unversity, Kangnam Sacred Heart Hospital, Seoul 07441, Korea.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Hallym Unversity, Chuncheon Sacred Heart Hospital, Chuncheon 24253, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9041024']
671,32259823,The Effect of a Thixotropic Nasal Gel on Nasal Symptoms and Inflammatory Biomarkers in Seasonal Allergic Rhinitis.,"BACKGROUND


Drug-free viscous nasal applications have been shown to reduce nasal symptoms in individuals with seasonal allergic rhinitis (SAR). Nascum®-Plus (NP), a commercially available thixotropic gel, has been designed to reduce dryness and soreness of the nasal mucosa and prevent the absorption of small particles.
OBJECTIVES


The aim of this study was to assess the efficacy of single-dose NP in treating nasal symptoms and secretion during challenge in an allergen challenge chamber (ACC). Furthermore, the effect of this treatment on biomarkers and immune cells of the allergic cascade were measured.
METHODS


This open-label, cross-over, sequence-randomized, monocentric trial randomized 18 adults with SAR and a positive skin prick test reaction to Dactylis glomerata pollen to receive NP or no treatment during two 4-h ACC sessions 3 weeks apart. On Day 1, 9 subjects were challenged for 4 h with treatment, the other 9 without treatment, and vice versa on Day 22. Nasal lavage fluid and nasal filter eluate samples were obtained pre, 2, and 18 h post challenge in the ACC.
RESULTS


NP significantly reduced nasal symptoms, assessed by total nasal symptom score (p < 0.001), and minimized nasal secretion (p = 0.047), while no significant effect on biomarkers and immune cells in the nasal fluid was observed. The treatment was safe and well-tolerated.
CONCLUSIONS


The physical barrier built by NP nasal gel can be safely applied in patients with allergic rhinitis. It reduces allergic nasal symptoms and secretion, but application of a single dose does not affect local inflammatory biomarkers.",2020,"RESULTS


NP significantly reduced nasal symptoms, assessed by total nasal symptom score (p < 0.001), and minimized nasal secretion (p = 0.047), while no significant effect on biomarkers and immune cells in the nasal fluid was observed.","['patients with allergic rhinitis', 'individuals with seasonal allergic rhinitis (SAR', '18 adults with SAR and a positive skin prick test reaction to Dactylis glomerata pollen to receive NP or no treatment during two 4-h ACC sessions 3 weeks apart', 'Seasonal Allergic Rhinitis']","['single-dose NP', 'Nascum®-Plus (NP', 'Thixotropic Nasal Gel']","['biomarkers and immune cells', 'allergic nasal symptoms and secretion', 'safe and well-tolerated', 'total nasal symptom score', 'Nasal Symptoms and Inflammatory Biomarkers', 'minimized nasal secretion', 'nasal symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0440327', 'cui_str': 'Orchard grass pollen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0991526', 'cui_str': 'Nasal gel'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]",18.0,0.0451303,"RESULTS


NP significantly reduced nasal symptoms, assessed by total nasal symptom score (p < 0.001), and minimized nasal secretion (p = 0.047), while no significant effect on biomarkers and immune cells in the nasal fluid was observed.","[{'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Struß', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Badorrek', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Mattern', 'Affiliation': 'M et P Pharma AG, Emmetten, Switzerland.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Mattern', 'Affiliation': 'M et P Pharma AG, Emmetten, Switzerland.'}, {'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Hohlfeld', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany, jens.hohlfeld@item.fraunhofer.de.'}]",International archives of allergy and immunology,['10.1159/000506129']
672,32260470,Bariatric Surgery Improves HDL Function Examined by ApoA1 Exchange Rate and Cholesterol Efflux Capacity in Patients with Obesity and Type 2 Diabetes.,"Bariatric surgery improves glycemic control better than medical therapy; however, the effect of bariatric surgery on HDL function is not well characterized. Serum samples were available at baseline, 1-, and 5-years post procedures, for 90 patients with obesity and type 2 diabetes who were randomized to intensive medical therapy ( n  = 20), Roux-en-Y gastric bypass (RYGB,  n  = 37), or sleeve gastrectomy (SG,  n  = 33) as part of the STAMPEDE clinical trial. We examined serum HDL function by two independent assays, apolipoprotein A-1 exchange rate (AER) and cholesterol efflux capacity (CEC). Compared with baseline, AER was significantly higher at 5 years for participants in all treatment groups, but only increased significantly at 1 year in the RYGB and SG groups. CEC was divided into ABCA1-dependent and independent fractions, and the later was correlated with AER. ABCA1-independent CEC increased significantly only at 5 years in both surgical groups, but did not significantly change in the medical therapy group. There was no significant change in ABCA1-dependent CEC in any group. The increase in AER, but not ABCA1-independent CEC, was correlated with the reduction in body mass index and glycated hemoglobin levels among all subjects at 5 years, indicating that AER as a measure of HDL function would be a better reflection of therapy versus CEC.",2020,"Compared with baseline, AER was significantly higher at 5 years for participants in all treatment groups, but only increased significantly at 1 year in the RYGB and SG groups.","['90 patients with obesity and type 2 diabetes', 'Patients with Obesity and Type 2 Diabetes']","['CEC', 'Roux-en-Y gastric bypass (RYGB,  n  = 37), or sleeve gastrectomy (SG', 'Bariatric Surgery', 'intensive medical therapy', 'Bariatric surgery']","['ABCA1-independent CEC', 'serum HDL function', 'ABCA1-dependent CEC', 'apolipoprotein A-1 exchange rate (AER) and cholesterol efflux capacity (CEC', 'body mass index and glycated hemoglobin levels', 'HDL Function Examined by ApoA1 Exchange Rate and Cholesterol Efflux Capacity', 'HDL function', 'AER']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C3711161', 'cui_str': 'ABCA1 protein, human'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C1677784', 'cui_str': 'APOA1 protein, human'}, {'cui': 'C1112870', 'cui_str': 'Drug aerosol'}]",90.0,0.0127405,"Compared with baseline, AER was significantly higher at 5 years for participants in all treatment groups, but only increased significantly at 1 year in the RYGB and SG groups.","[{'ForeName': 'Shuhui Wang', 'Initials': 'SW', 'LastName': 'Lorkowski', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Brubaker', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Rotroff', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Sangeeta R', 'Initials': 'SR', 'LastName': 'Kashyap', 'Affiliation': 'Endocrinology Institute, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Schauer', 'Affiliation': 'Bariatric and Metabolic Institute, Department of General Surgery, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Bariatric and Metabolic Institute, Department of General Surgery, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Smith', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences, Cleveland Clinic, Cleveland, OH 44195, USA.'}]",Biomolecules,['10.3390/biom10040551']
673,32260099,Which Effects on Neuroanatomy and Path-Integration Survive? Results of a Randomized Controlled Study on Intensive Balance Training.,"Balancing is a complex task requiring the integration of visual, somatosensory and vestibular inputs. The vestibular system is linked to the hippocampus, a brain structure crucial for spatial orientation. Here we tested the immediate and sustained effects of a one-month-long slackline training program on balancing and orientation abilities as well as on brain volumes in young adults without any prior experience in that skill. On the corrected level, we could not find any interaction effects for brain volumes, but the effect sizes were small to medium. A subsequent within-training-group analysis revealed volumetric increments within the somatosensory cortex and decrements within posterior insula, cerebellum and putamen remained stable over time. No significant interaction effects were observed on the clinical balance and the spatial orientation task two months after the training period (follow-up). We interpret these findings as a shift away from processes crucial for automatized motor output towards processes related to voluntarily controlled movements. The decrease in insular volume in the training group we propose to result from multisensory interaction of the vestibular with the visual and somatosensory systems. The discrepancy between sustained effects in the brain of the training group on the one hand and transient benefits in function on the other may indicate that for the latter to be retained a longer-term practice is required.",2020,No significant interaction effects were observed on the clinical balance and the spatial orientation task two months after the training period (follow-up).,['young adults without any prior experience in that skill'],"['slackline training program', 'Intensive Balance Training']","['insular volume', 'brain volumes', 'clinical balance and the spatial orientation task']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0179199', 'cui_str': 'Balance'}, {'cui': 'C0037744', 'cui_str': 'Space Perception'}]",,0.025205,No significant interaction effects were observed on the clinical balance and the spatial orientation task two months after the training period (follow-up).,"[{'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Dordevic', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), 39120 Magdeburg, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Taubert', 'Affiliation': 'Center for Behavioral Brain Sciences (CBBS), 39106 Magdeburg, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Müller', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), 39120 Magdeburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Riemer', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), 39120 Magdeburg, Germany.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Kaufmann', 'Affiliation': 'Neurology Clinic, Otto von Guericke University, 39120 Magdeburg, Germany.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hökelmann', 'Affiliation': 'Chair for Training Science ""Cognition and Motion"", Department Sports Science, Otto von Guericke University, 39104 Magdeburg, Germany.'}, {'ForeName': 'Notger G', 'Initials': 'NG', 'LastName': 'Müller', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), 39120 Magdeburg, Germany.'}]",Brain sciences,['10.3390/brainsci10040210']
674,31743184,"Incentive-Based Game for Allaying Preoperative Anxiety in Children: A Prospective, Randomized Trial.","BACKGROUND


Induction of anesthesia can be distressing both for children and their parents. Nonpharmacological behavioral interventions can reduce the anxiety of children without significant adverse effects as seen with sedative medications. We hypothesized that the use of incentive-based game therapy in conjunction with parental involvement would be a simple and cost-effective intervention in reducing the preoperative anxiety in children.
METHODS


Eighty children between the age group of 4 and 8 years scheduled to undergo surgery were randomly assigned to a control group (n = 40) and intervention group (n = 40). Children in the intervention group participated in an incentive-based game in the preoperative room. Anesthesia was induced with parental presence in both the groups. The modified Yale Preoperative Anxiety Scale (mYPAS) score to measure the anxiety of the children during induction was taken as the primary outcome. Induction Compliance Checklist score and parental satisfaction were assessed as secondary outcomes.
RESULTS


The mYPAS score of children in the intervention group was significantly less than the control group during anesthesia induction. The mean difference (95% confidence interval [CI]) of the mYPAS at induction between the 2 groups was 20 (95% CI, 16-24; P < .001). Fourteen (35%) children in the intervention group and 2 (5%) children in control group displayed no anxiety (mYPAS score <30) (difference of -30%; 95% CI, -11% to -49%; P < .001). Children in the intervention group were more compliant with mask induction and had a significantly less Induction Compliance Checklist score compared to the control (P < .001). Thirty (75%) parents in the intervention group were satisfied at the end of surgery compared to 6 (15%) in the control group (difference of -60%; 95% CI, -39% to -73%; P < .001).
CONCLUSIONS


The use of incentive-based game therapy reduces the anxiety scores during induction of anesthesia and improves the compliance to facemask induction in children undergoing surgery. It can form a simple, cost-effective, and easy-to-administer technique that can be easily applied in low-income settings.",2019,Children in the intervention group were more compliant with mask induction and had a significantly less Induction Compliance Checklist score compared to the control (P < .001).,"['Children', 'children', 'Eighty children between the age group of 4 and 8 years scheduled to undergo surgery', 'children and their parents', 'children undergoing surgery']","['Incentive-Based Game', 'incentive-based game in the preoperative room', 'incentive-based game therapy', 'Nonpharmacological behavioral interventions']","['Induction Compliance Checklist score and parental satisfaction', 'anxiety scores', 'compliant with mask induction', 'modified Yale Preoperative Anxiety Scale (mYPAS) score', 'Induction Compliance Checklist score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0566588', 'cui_str': 'Compliant (qualifier value)'}, {'cui': 'C0412768', 'cui_str': 'Inhalational induction (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0222045'}]",80.0,0.0671848,Children in the intervention group were more compliant with mask induction and had a significantly less Induction Compliance Checklist score compared to the control (P < .001).,"[{'ForeName': 'Bijay', 'Initials': 'B', 'LastName': 'Chaurasia', 'Affiliation': 'From the Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': ''}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ''}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Gandhi', 'Affiliation': ''}, {'ForeName': 'Preethy J', 'Initials': 'PJ', 'LastName': 'Mathew', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003717']
675,31743196,Effect of Remote Ischemic Preconditioning in Patients Undergoing Hepatectomy With Portal Triad Clamping: A Randomized Controlled Trial.,"BACKGROUND


Remote ischemic preconditioning (RIPC) is reported to reduce liver injury in patients undergoing hepatectomy for colorectal liver metastasis, but its role is unclear in hepatocellular carcinoma patients with portal triad clamping during hepatectomy.
METHODS


In this prospective, randomized trial, 140 patients with hepatocellular carcinoma undergoing liver resection requiring portal triad clamping were randomized to a RIPC group or a control group. Patients in the RIPC group received RIPC (3 cycles of 5-minute ischemia and 5-minute reperfusion in right upper limb with cuff pressure at 30 kPa [225 mm Hg]) approximately 10 minutes after induction of anesthesia. In the control group, patients received sham RIPC (the cuff was not inflated). The primary outcome was the postoperative peak level of total bilirubin (TBIL) and was analyzed with the independent t test. Secondary outcomes were liver function test at postoperative days 1, 3, and 5; postoperative morbidity and mortality during the first month; and the length of postoperative hospital stay.
RESULTS


Data from 136 patients (69 in the RIPC group and 67 in the control group) were analyzed. The RIPC group had on average a 5.9 μmol lower peak level of TBIL than the control group; the mean difference is -5.9, and the 95% confidence interval (CI) reverses to -17.9 to 6.1. There were no significant differences between the 2 groups in liver function test at postoperative days 1, 3, and 5; postoperative morbidity and mortality during the first month; and the length of postoperative hospital stay.
CONCLUSIONS


We found no evidence that RIPC can reduce postoperative liver injury after hepatectomy.",2019,"There were no significant differences between the 2 groups in liver function test at postoperative days 1, 3, and 5; postoperative morbidity and mortality during the first month; and the length of postoperative hospital stay.
","['patients undergoing hepatectomy for colorectal liver metastasis', 'Patients Undergoing Hepatectomy', '140 patients with hepatocellular carcinoma undergoing liver resection requiring portal triad clamping', 'hepatocellular carcinoma patients with portal triad clamping during hepatectomy', '136 patients (69 in the RIPC group and 67 in the control group) were analyzed']","['Remote ischemic preconditioning (RIPC', 'Portal Triad Clamping', 'Remote Ischemic Preconditioning', 'sham RIPC', 'RIPC']","['liver function test', 'postoperative peak level of total bilirubin (TBIL', 'postoperative morbidity and mortality', 'length of postoperative hospital stay', 'liver function test at postoperative days 1, 3, and 5; postoperative morbidity and mortality during the first month; and the length of postoperative hospital stay', 'peak level of TBIL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0227514', 'cui_str': 'Portal triad structure'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0227514', 'cui_str': 'Portal triad structure'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0023901', 'cui_str': 'Liver Function Tests'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",140.0,0.197495,"There were no significant differences between the 2 groups in liver function test at postoperative days 1, 3, and 5; postoperative morbidity and mortality during the first month; and the length of postoperative hospital stay.
","[{'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'From the Department of Anesthesia, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Longhui', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'From the Department of Anesthesia, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Tianhua', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Anesthesia, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Rongping', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Departments of Hepatology.'}, {'ForeName': 'Wenqian', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'From the Department of Anesthesia, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China and Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004434']
676,31740387,Exercise training induces insulin-sensitizing PAHSAs in adipose tissue of elderly women.,"Adverse effects of aging can be delayed with life-style interventions. We examined how exercise training (ET) alone or combined with omega-3 polyunsaturated fatty acid (PUFA) affects serum and adipose tissue (AT) lipidome in older women. Fifty-five sedentary older women were included in the physical activity program and given either sunflower (Placebo) or wax esters-rich (Calanus) oil capsules for 4 months. Serum and subcutaneous abdominal AT samples were acquired while maximum rates of oxygen consumption (VO 2  max), insulin sensitivity (hyperinsulinemic-euglycemic clamps) and comprehensive lipidome profiles were determined before and after the study. ET increased VO 2  max in both groups. Lipidomics profiling revealed unusual serum triacylglycerols and phospholipids with ether-bound alkyls in the Calanus group, while ET generally induced shorter-chain triacylglycerols in AT, suggesting increased de novo lipogenesis. The latter was positively associated with whole-body insulin sensitivity. Unexpectedly, insulin-sensitizing lipokines from the family of branched palmitic acid esters of hydroxy stearic acid (PAHSAs) were elevated in both serum and AT after ET, while PAHSAs-containing triacylglycerols were detected in AT. ET stimulated beneficial changes in AT, including PAHSAs synthesis. Although the added value of omega-3 PUFA supplementation was not proven, our discovery can help understand the nature of the metabolic benefits of exercise.",2020,ET increased VO 2  max in both groups.,"['Fifty-five sedentary older women', 'adipose tissue of elderly women', 'older women']","['physical activity program and given either sunflower (Placebo) or wax esters-rich (Calanus) oil capsules', 'exercise training (ET) alone or combined with omega-3 polyunsaturated fatty acid (PUFA', 'omega-3 PUFA supplementation', 'Exercise training']","['serum and adipose tissue (AT) lipidome', 'ET increased VO 2  max', 'whole-body insulin sensitivity', 'oxygen consumption (VO 2  max), insulin sensitivity (hyperinsulinemic-euglycemic clamps) and comprehensive lipidome profiles']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0740486', 'cui_str': 'Ear Wax'}, {'cui': 'C0014898', 'cui_str': 'Esters'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}]",55.0,0.0201206,ET increased VO 2  max in both groups.,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Brezinova', 'Affiliation': 'Institute of Physiology of the Czech Academy of Sciences, Videnska 1083, 14220 Prague 4, Czech Republic.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Cajka', 'Affiliation': 'Institute of Physiology of the Czech Academy of Sciences, Videnska 1083, 14220 Prague 4, Czech Republic.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Oseeva', 'Affiliation': 'Institute of Physiology of the Czech Academy of Sciences, Videnska 1083, 14220 Prague 4, Czech Republic.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Stepan', 'Affiliation': 'Department of Pathophysiology, Third Faculty of Medicine, Charles University, 100 00 Prague, Czech Republic; 2nd Internal Medicine Department, Kralovske Vinohrady University Hospital, 100 34 Prague, Czech Republic.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Dadova', 'Affiliation': 'Faculty of Physical Education and Sports, Charles University, José Martího 31, 162 52 Prague, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Rossmeislova', 'Affiliation': 'Department of Pathophysiology, Third Faculty of Medicine, Charles University, 100 00 Prague, Czech Republic.'}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Matous', 'Affiliation': 'Department of Pathophysiology, Third Faculty of Medicine, Charles University, 100 00 Prague, Czech Republic.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Siklova', 'Affiliation': 'Department of Pathophysiology, Third Faculty of Medicine, Charles University, 100 00 Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rossmeisl', 'Affiliation': 'Institute of Physiology of the Czech Academy of Sciences, Videnska 1083, 14220 Prague 4, Czech Republic. Electronic address: martin.rossmeisl@fgu.cas.cz.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Kuda', 'Affiliation': 'Institute of Physiology of the Czech Academy of Sciences, Videnska 1083, 14220 Prague 4, Czech Republic. Electronic address: ondrej.kuda@fgu.cas.cz.'}]",Biochimica et biophysica acta. Molecular and cell biology of lipids,['10.1016/j.bbalip.2019.158576']
677,31941445,Anticipated HIV stigma among HIV negative men who have sex with men in China: a cross-sectional study.,"BACKGROUND


Anticipated HIV stigma, i.e., the expectation of adverse experiences from one's seroconversion, is associated with both negative psychological and behavioral outcomes. We know little about anticipated HIV stigma's relationship with emerging technologies, such as HIV self-testing (HIVST) and online sex-seeking platforms, that have become popular among populations that are disproportionately affected by HIV/AIDS. This study examined correlates of anticipated HIV stigma among Chinese men who have sex with men (MSM).
METHODS


In July 2016, MSM, who were ≥ 16 years old and self-reported as HIV negative or unknown, were recruited from a gay mobile phone application in China. Information regarding socio-demographics, sexual behaviors, sexual health service utilization, and anticipated HIV stigma were collected. Anticipated HIV stigma (i.e., negative attitude toward future stigmatization of HIV seroconversion by others) was measured as the mean score from a 7-item Likert-scale ranging from 1 (low) to 4 (high). Generalized linear models were conducted to examine the factors associated with the anticipated HIV stigma scores.
RESULTS


Overall, 2006 men completed the survey. Most men completed high school (1308/2006, 65.2%) and had an annual personal income of ≤9200 USD (1431/2006, 71.3%). The mean anticipated HIV stigma score for the participants was 2.98 ± 0.64. Using social media to seek sexual partners was associated with higher anticipated HIV stigma (Adjusted β = 0.11, 95% confidence interval (CI): 0.05 to 0.17, p = 0.001). HIV self-testing (Adjusted β = - 0.07, 95%CI: - 0.13 to - 0.01, p = 0.02) and having disclosed one's sexual orientation to a healthcare provider (Adjusted β = - 0.16, 95%CI: - 0.22 to - 0.96, p < 0.001) were associated with lower anticipated HIV stigma.
CONCLUSION


Our data suggested that anticipated HIV stigma is still common among Chinese MSM not living with HIV. Tailored anti-HIV stigma campaigns on social media are especially needed, and the promotion of HIVST may be a promising approach.",2020,"Using social media to seek sexual partners was associated with higher anticipated HIV stigma (Adjusted β = 0.11, 95% confidence interval (CI): 0.05 to 0.17, p = 0.001).","['HIV negative men who have sex with men in China', 'Most men completed high school (1308/2006, 65.2%) and had an annual personal income of ≤9200 USD ', '2006 men completed the survey', 'Chinese men who have sex with men (MSM', '16\u2009years old and self-reported as HIV negative or unknown, were recruited from a gay mobile phone application in China']",[],"['HIV stigma', 'socio-demographics, sexual behaviors, sexual health service utilization, and anticipated HIV stigma', 'mean anticipated HIV stigma score', 'HIV stigma scores']","[{'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557168', 'cui_str': 'Individual income'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0380416,"Using social media to seek sexual partners was associated with higher anticipated HIV stigma (Adjusted β = 0.11, 95% confidence interval (CI): 0.05 to 0.17, p = 0.001).","[{'ForeName': 'Chuncheng', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Pan', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Bolin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Ong', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Fu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Chongyi', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Dermatology Hospital of Southern Medical University and the University of North Carolina Project-China, No.2 Lujing Road, Guangzhou, 510095, China. weimingtangscience@gmail.com.'}]",BMC infectious diseases,['10.1186/s12879-020-4778-5']
678,31600598,A two-part phase 1 study to establish and compare the safety and local tolerability of two nasal formulations of XF-73 for decolonisation of Staphylococcus aureus: A previously investigated 0.5mg/g viscosified gel formulation versus a modified formulation.,"OBJECTIVES


Successful decolonisation of nasal Staphylococcus aureus (SA) carriage by mupirocin is limited by increasing drug resistance. This randomised, open-label, phase 1 study compared the safety and local tolerability of two nasal formulations of XF-73, a novel porphyrinic antibacterial with rapid intrinsic activity against SA.
METHODS


The study was performed in 60 healthy adults. In Part 1, eight non-SA carriers were randomised to groups of four subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel or 2.0mg/g 2% gel. In Part 2, 52 persistent SA carriers were randomised to groups of 13 subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel, 2.0mg/g 2% gel, 0.5mg/g 4% gel or 4% viscosified placebo gel. Plasma pharmacokinetic and pharmacodynamic studies were performed. Antistaphylococcal activity was assessed as the presence/absence of SA and by quantification of colonisation using a semiquantitative scale (SA score).
RESULTS


56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the pharmacokinetic population and 48/60 the pharmacodynamic population. There was no measurable systemic absorption of XF-73. XF-73 treatment was associated with rapid reduction in SA score in all subjects. The most common treatment-emergent adverse events (TEAEs) were rhinorrhoea and nasal dryness (15.5% each in Parts 1 and 2). TEAEs were mild and resolved spontaneously.
CONCLUSION


XF-73 was well tolerated with minimal side effects at doses of 0.5mg/g 2% gel and 2.0mg/g 2% gel. These findings support further development of XF-73.",2019,"CONCLUSION


XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","['2 dosing cohorts, and enrolled 60 healthy adults', '56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the PK population and 48/60 the PD population', '52 healthy persistent SA carriers', 'Staphylococcus aureus', 'healthy volunteers']","['XF-73 in concentrations of 0.5\u2009mg/g 2% gel and 2\u2009mg/g 2% gel, respectively', 'XF-73', 'XF-73 (0.5\u2009mg/g 2% gel, 2\u2009mg/g 2% gel and 0.5\u2009mg/g 4% gel) or a 4% viscosified placebo gel']","['systemic absorption of XF-73', 'safety and local tolerability', 'Anti-staphylococcal activity', 'rhinorrhea and nasal dryness', 'SA scores', 'Plasma pharmacokinetics (PK) and pharmacodynamics (PD) studies']","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3850076', 'cui_str': 'Systemic Absorption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0231919', 'cui_str': 'Nasal mucosa dry (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",60.0,0.0287411,"CONCLUSION


XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Yendewa', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA. Electronic address: gay7@case.edu.'}, {'ForeName': 'J McLeod', 'Initials': 'JM', 'LastName': 'Griffiss', 'Affiliation': 'ClinicalRM, Hinckley, OH, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jacobs', 'Affiliation': 'Department of Pathology, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Fulton', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': ""O'Riordan"", 'Affiliation': 'Department of Pediatrics, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Wesley A', 'Initials': 'WA', 'LastName': 'Gray', 'Affiliation': 'Department of Pediatrics, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Proskin', 'Affiliation': 'Howard M. Proskin and Associates, Incorporated, Rochester, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Winkle', 'Affiliation': 'Anaheim Clinical Trials, Anaheim, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Salata', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2019.09.017']
679,31742631,Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial.,"Importance


Ubrogepant is an oral calcitonin gene-related peptide receptor antagonist under investigation for acute treatment of migraine.
Objective


To evaluate the efficacy and tolerability of ubrogepant compared with placebo for acute treatment of a single migraine attack.
Design, Setting, and Participants


Phase 3, multicenter, randomized, double-blind, placebo-controlled, single-attack, clinical trial (ACHIEVE II) conducted in the United States (99 primary care and research clinics; August 26, 2016-February 26, 2018). Participants were adults with migraine with or without aura experiencing 2 to 8 migraine attacks per month.
Interventions


Ubrogepant 50 mg (n = 562), ubrogepant 25 mg (n = 561), or placebo (n = 563) for a migraine attack of moderate or severe pain intensity.
Main Outcomes and Measures


Co-primary efficacy outcomes were pain freedom and absence of the participant-designated most bothersome migraine-associated symptom (among photophobia, phonophobia, and nausea) at 2 hours after taking the medication.
Results


Among 1686 randomized participants, 1465 received study treatment (safety population; mean age, 41.5 years; 90% female); 1355 of 1465 (92.5%) were evaluable for efficacy. Pain freedom at 2 hours was reported by 101 of 464 participants (21.8%) in the ubrogepant 50-mg group, 90 of 435 (20.7%) in the ubrogepant 25-mg group, and 65 of 456 (14.3%) in the placebo group (absolute difference for 50 mg vs placebo, 7.5%; 95% CI, 2.6%-12.5%; P = .01; 25 mg vs placebo, 6.4%; 95% CI, 1.5%-11.5%; P = .03). Absence of the most bothersome associated symptom at 2 hours was reported by 180 of 463 participants (38.9%) in the ubrogepant 50-mg group, 148 of 434 (34.1%) in the ubrogepant 25-mg group, and 125 of 456 (27.4%) in the placebo group (absolute difference for 50 mg vs placebo, 11.5%; 95% CI, 5.4%-17.5%; P = .01; 25 mg vs placebo, 6.7%; 95% CI, 0.6%-12.7%; P = .07). The most common adverse events within 48 hours of any dose were nausea (50 mg, 10 of 488 [2.0%]; 25 mg, 12 of 478 [2.5%]; and placebo, 10 of 499 [2.0%]) and dizziness (50 mg, 7 of 488 [1.4%]; 25 mg, 10 of 478 [2.1%]; placebo, 8 of 499 [1.6%]).
Conclusions and Relevance


Among adults with migraine, acute treatment with ubrogepant compared with placebo led to significantly greater rates of pain freedom at 2 hours with 50-mg and 25-mg doses, and absence of the most bothersome migraine-associated symptom at 2 hours only with the 50-mg dose. Further research is needed to assess the effectiveness of ubrogepant against other acute treatments for migraine and to evaluate the long-term safety of ubrogepant among unselected patient populations.
Trial Registration


ClinicalTrials.gov Identifier: NCT02867709.",2019,"Pain freedom at 2 hours was reported by 101 of 464 participants (21.8%) in the ubrogepant 50-mg group, 90 of 435 (20.7%) in the ubrogepant 25-mg group, and 65 of 456 (14.3%) in the placebo group (absolute difference for 50 mg vs placebo, 7.5%; 95% CI, 2.6%-12.5%; P = .01; 25 mg vs placebo, 6.4%; 95% CI, 1.5%-11.5%; P = .03).","['adults with migraine', 'Acute Treatment of Migraine', 'Participants were adults with migraine with or without aura experiencing 2 to 8 migraine attacks per month', '1686 randomized participants, 1465 received study treatment (safety population; mean age, 41.5 years; 90% female); 1355 of 1465 (92.5%) were evaluable for efficacy', 'United States (99 primary care and research clinics']","['placebo', 'Ubrogepant vs Placebo']","['dizziness', 'rates of pain freedom', 'pain freedom and absence of the participant-designated most bothersome migraine-associated symptom (among photophobia, phonophobia, and nausea', 'Pain', 'efficacy and tolerability', 'nausea', 'Pain freedom']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0035168'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}, {'cui': 'C0751466', 'cui_str': 'Phonophobia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",1686.0,0.495495,"Pain freedom at 2 hours was reported by 101 of 464 participants (21.8%) in the ubrogepant 50-mg group, 90 of 435 (20.7%) in the ubrogepant 25-mg group, and 65 of 456 (14.3%) in the placebo group (absolute difference for 50 mg vs placebo, 7.5%; 95% CI, 2.6%-12.5%; P = .01; 25 mg vs placebo, 6.4%; 95% CI, 1.5%-11.5%; P = .03).","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Montefiore Headache Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ailani', 'Affiliation': 'Medstar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Allergan plc, Madison, New Jersey.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Finnegan', 'Affiliation': 'Allergan plc, Madison, New Jersey.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Szegedi', 'Affiliation': 'Allergan plc, Madison, New Jersey.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Trugman', 'Affiliation': 'Allergan plc, Madison, New Jersey.'}]",JAMA,['10.1001/jama.2019.16711']
680,31748227,"Antigenic competition in CD4 +  T cell responses in a randomized, multicenter, double-blind clinical HIV vaccine trial.","T cell responses have been implicated in reduced risk of HIV acquisition in uninfected persons and control of viral replication in HIV-infected individuals. HIV Gag-specific T cells have been predominantly associated with post-infection control, whereas Env antigens are the target for protective antibodies; therefore, inclusion of both antigens is common in HIV vaccine design. However, inclusion of multiple antigens may provoke antigenic competition, reducing the potential effectiveness of the vaccine. HVTN 084 was a randomized, multicenter, double-blind phase 1 trial to investigate whether adding Env to a Gag/Pol vaccine decreases the magnitude or breadth of Gag/Pol-specific T cell responses. Fifty volunteers each received one intramuscular injection of 1 × 10 10  particle units (PU) of rAd5 Gag/Pol and EnvA/B/C (3:1:1:1 mixture) or 5 × 10 9  PU of rAd5 Gag/Pol. CD4 +  T cell responses to Gag/Pol measured 4 weeks after vaccination by cytokine expression were significantly higher in the group vaccinated without Env, whereas CD8 +  T cell responses did not differ significantly between the two groups. Mapping of individual epitopes revealed greater breadth of the Gag/Pol-specific T cell response in the absence of Env compared to Env coimmunization. Addition of an Env component to a Gag/Pol vaccine led to reduced Gag/Pol CD4 +  T cell response rate and magnitude as well as reduced epitope breadth, confirming the presence of antigenic competition. Therefore, T cell-based vaccine strategies should aim at choosing a minimalist set of antigens to reduce interference of individual vaccine components with the induction of the maximally achievable immune response.",2019,"CD4 +  T cell responses to Gag/Pol measured 4 weeks after vaccination by cytokine expression were significantly higher in the group vaccinated without Env, whereas CD8 +  T cell responses did not differ significantly between the two groups.",['Fifty volunteers each received one'],['intramuscular injection of 1 × 10 10  particle units (PU) of rAd5 Gag/Pol and EnvA/B/C (3:1:1:1 mixture) or 5 × 10 9  PU of rAd5 Gag/Pol'],"['Gag/Pol CD4 +  T cell response rate', 'CD8 +  T cell responses', 'breadth of the Gag/Pol-specific T cell response', 'magnitude or breadth of Gag/Pol-specific T cell responses', 'CD4 +  T cell responses', 'cytokine expression']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}]","[{'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",50.0,0.193547,"CD4 +  T cell responses to Gag/Pol measured 4 weeks after vaccination by cytokine expression were significantly higher in the group vaccinated without Env, whereas CD8 +  T cell responses did not differ significantly between the two groups.","[{'ForeName': 'Esper G', 'Initials': 'EG', 'LastName': 'Kallas', 'Affiliation': 'Division of Clinical Immunology and Allergy, University of São Paulo, São Paulo 05508, Brazil.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Grunenberg', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Bryce', 'Initials': 'B', 'LastName': 'Manso', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Division of Immunology and Allergy, Lausanne University Hospital (CHUV), 1011 Lausanne, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Casapia', 'Affiliation': 'Asociación Civil Selva Amazónica, Iquitos 16002, Peru.'}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Valencia', 'Affiliation': 'Asociación Civil Impacta Salud Y Educación, Lima 15063, Peru.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Sobieszczyk', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY 10025, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Van Tieu', 'Affiliation': 'Laboratory of Infectious Disease Prevention, New York Blood Center, New York, NY 10065, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Division of AIDS, National Institute for Allergy and Infectious Diseases, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hural', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Graham', 'Affiliation': 'Vaccine Research Center, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Goepfert', 'Affiliation': 'Division of Infectious Disease and Department of Surgery, Division of Gastroenterology, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL 35294, USA.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Johnson', 'Affiliation': 'Yerkes National Primate Research Center, School of Medicine, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Yunda', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA. nicole.frahm@gatesmri.org.'}]",Science translational medicine,['10.1126/scitranslmed.aaw1673']
681,31743188,Cervical Spine Motion During Tracheal Intubation Using an Optiscope Versus the McGrath Videolaryngoscope in Patients With Simulated Cervical Immobilization: A Prospective Randomized Crossover Study.,"BACKGROUND


In patients with an unstable cervical spine, maintenance of cervical immobilization during tracheal intubation is important. In McGrath videolaryngoscopic intubation, lifting of the blade to raise the epiglottis is needed to visualize the glottis, but in patients with an unstable cervical spine, this can cause cervical spine movement. By contrast, the Optiscope, a rigid video-stylet, does not require raising of the epiglottis during tracheal intubation. We therefore hypothesized that the Optiscope would produce less cervical spine movement than the McGrath videolaryngoscope during tracheal intubation. The aim of this study was to compare the Optiscope with the McGrath videolaryngoscope with respect to cervical spine motion during intubation in patients with simulated cervical immobilization.
METHODS


The primary outcome of the study was the extent of cervical spine motion at the occiput-C1, C1-C2, and C2-C5 segments. In this randomized crossover study, the cervical spine angle was measured before and during tracheal intubation using either the Optiscope or the McGrath videolaryngoscope in 21 patients with simulated cervical immobilization. Cervical spine motion was defined as the change in angle at each cervical segment during tracheal intubation.
RESULTS


There was significantly less cervical spine motion at the occiput-C1 segment using the Optiscope rather than the McGrath videolaryngoscope (mean [98.33% CI]: 4.7° [2.4-7.0] vs 10.4° [8.1-12.7]; mean difference [98.33% CI]: -5.7° [-7.5 to -3.9]). There were also fewer cervical spinal motions at the C1-C2 and C2-C5 segments using the Optiscope (mean difference versus the McGrath videolaryngoscope [98.33% CI]: -2.4° [-3.7 to -1.2]) and -3.7° [-5.9 to -1.4], respectively).
CONCLUSIONS


The Optiscope produces less cervical spine motion than the McGrath videolaryngoscope during tracheal intubation of patients with simulated cervical immobilization.",2019,There was significantly less cervical spine motion at the occiput-C1 segment using the Optiscope rather than the McGrath videolaryngoscope (mean [98.33% CI]:,"['Patients With Simulated Cervical Immobilization', '21 patients with simulated cervical immobilization', 'patients with simulated cervical immobilization', 'patients with an unstable cervical spine, maintenance of cervical immobilization during tracheal intubation']",['Tracheal Intubation Using an Optiscope Versus the McGrath Videolaryngoscope'],"['cervical spine motion', 'cervical spine movement', 'cervical spine motion at the occiput-C1, C1-C2, and C2-C5 segments', 'cervical spinal motions', 'Cervical spine motion', 'Cervical Spine Motion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]","[{'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope (physical object)'}]","[{'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}]",,0.0240296,There was significantly less cervical spine motion at the occiput-C1 segment using the Optiscope rather than the McGrath videolaryngoscope (mean [98.33% CI]:,"[{'ForeName': 'Karam', 'Initials': 'K', 'LastName': 'Nam', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Younsuk', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dongguk University Medical Center Ilsan Hospital, Dongguk University College of Medicine, Goyang, Korea.'}, {'ForeName': 'Hee-Pyoung', 'Initials': 'HP', 'LastName': 'Park', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jaeyeon', 'Initials': 'J', 'LastName': 'Chung', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyun-Kyu', 'Initials': 'HK', 'LastName': 'Yoon', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Tae Kyong', 'Initials': 'TK', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003635']
682,31037789,Exploratory analysis of treatment response trajectories in the PRISM trial: Models of psychosocial care.,"OBJECTIVE


Adolescents and young adults (AYAs) with cancer are at high risk of negative psychosocial outcomes. Promoting Resilience in Stress Management (PRISM), a novel, brief, skill-based intervention, has demonstrated efficacy in improving psychosocial well-being for AYAs. We utilized data from a recent randomized trial of PRISM versus usual care (UC) to categorize and explore group differences in change trajectories of patient reported outcomes (PROs) over time.
METHODS


One hundred English-speaking AYAs (aged 12-25 years old) with cancer were randomized to PRISM versus UC. At enrollment and 6 months later, AYAs completed validated PROs measuring resilience (Connor-Davidson Resilience Scale [CDRISC-10]), hope (Hope Scale), benefit finding (Benefit and Burden Scale for Children), cancer-specific quality of life (Pediatric Quality of Life [PedsQL] Cancer Module), and distress (Kessler-6). Patient response trajectories were categorized as ""improved,"" ""consistently well,"" ""consistently at risk,"" or ""deteriorated"" using minimal clinically important differences (MCIDs) or established measure cutoffs for all PROs. Positive response trajectories consisted of the first two categories (""improved"" and ""consistently well""), and negative response trajectories consisted of the latter two categories (""consistently at risk"" and ""deteriorated"").
RESULTS


Across all PROs, more patients in the PRISM arm ""improved"" in psychosocial well-being over time, and fewer PRISM recipients ""deteriorated"" over time. Across all PROs, a greater proportion of PRISM participants (vs UC) experienced positive response trajectories. Across all PROs, a greater proportion of UC participants experienced negative response trajectories.
CONCLUSIONS


PRISM shows evidence of both a prevention effect and an intervention effect. Thus, PRISM may serve as a viable prevention and early intervention model for psychosocial care.",2019,"Across all PROs, more patients in the PRISM arm ""improved"" in psychosocial well-being over time, and fewer PRISM recipients ""deteriorated"" over time.","['Adolescents and young adults (AYAs) with cancer', 'One hundred English-speaking AYAs (aged 12-25 years old) with cancer']","['PRISM versus UC', 'PRISM versus usual care (UC']","['PROs measuring resilience (Connor-Davidson Resilience Scale [CDRISC-10]), hope (Hope Scale), benefit finding (Benefit and Burden Scale for Children), cancer-specific quality of life (Pediatric Quality of Life [PedsQL] Cancer Module), and distress (Kessler-6']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[],"[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",100.0,0.0429357,"Across all PROs, more patients in the PRISM arm ""improved"" in psychosocial well-being over time, and fewer PRISM recipients ""deteriorated"" over time.","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lau', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Bradford', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Steineck', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Courtney C', 'Initials': 'CC', 'LastName': 'Junkins', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Joyce P', 'Initials': 'JP', 'LastName': 'Yi-Frazier', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McCauley', 'Affiliation': 'Division of Child Psychiatry, Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Rosenberg', 'Affiliation': ""Palliative Care and Resilience Research Program, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}]",Psycho-oncology,['10.1002/pon.5098']
683,31010372,Beneficial Effects of Acute Exercise on Executive Function in Adolescents.,"Background : Evidence supports that a single session of exercise has benefits for cognitive performance following exercise. Although the vast majority of research has been conducted with young adults, very few studies to date have tested these effects in adolescents (high school aged students). As executive function (EF) develops through late adolescence and into young adulthood, it is important to assess the extent to which acute exercise benefits EF in adolescents. The primary purpose of this study was to assess the effect of moderate-intensity acute exercise on subsequent EF performance in this population.  Methods : Healthy high school students (N = 22; age: 15.90 [0.29] y) volunteered to participate in the study. Using a within-subjects design with order of conditions randomized and counterbalanced, participants performed the Stroop Test, the Symbol Digit Modalities Test, and the Tower of London Test following control and following exercise with sessions performed on different days.  Results : Exercise resulted in significant benefits for Stroop Color, Stroop Color-Word tests, Symbol Digit Modalities Test, Tower of London total moves, and Tower of London total excess moves.  Conclusions : These results provide an important extension to the literature by confirming that 20 minutes of moderate-intensity exercise benefits EF performance in high school students.",2019,"Exercise resulted in significant benefits for Stroop Color, Stroop Color-Word tests, Symbol Digit Modalities Test, Tower of London total moves, and Tower of London total excess moves.  ","['high school students', 'adolescents', 'Healthy high school students (N\u2009=\u200922; age: 15.90 [0.29', 'Adolescents', 'y) volunteered to participate in the study', 'adolescents (high school aged students']","['Acute Exercise', ' ', 'moderate-intensity acute exercise']","['subsequent EF performance', 'Stroop Color, Stroop Color-Word tests, Symbol Digit Modalities Test, Tower of London total moves, and Tower of London total excess moves', 'Executive Function']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517446', 'cui_str': '0.29'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0582675', 'cui_str': 'Stroop neuropsychological screening test (assessment scale)'}, {'cui': 'C0451522', 'cui_str': 'Symbol Digit Modalities Test'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0578671', 'cui_str': 'Does move (finding)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0522542,"Exercise resulted in significant benefits for Stroop Color, Stroop Color-Word tests, Symbol Digit Modalities Test, Tower of London total moves, and Tower of London total excess moves.  ","[{'ForeName': 'SeYun', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Etnier', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0219']
684,31743193,"Impact of Local Infiltration Analgesia on the Quality of Recovery After Anterior Total Hip Arthroplasty: A Randomized, Triple-Blind, Placebo-Controlled Trial.","BACKGROUND


Local infiltration analgesia (LIA) is commonly used in anterior total hip arthroplasty (THA) surgery; however, evidence for its efficacy is lacking. We hypothesized that LIA with 0.2% ropivacaine when compared with injection of placebo (0.9% saline) would improve patient quality of recovery on postoperative day (POD) 1, as measured by the Quality of Recovery-15 (QoR-15) score.
METHODS


Patients scheduled to have a primary unilateral anterior THA with a single surgeon in a tertiary level metropolitan hospital were randomized to receive LIA with either 2.5 mL/kg of 0.2% ropivacaine or 0.9% saline as placebo. Patients and clinical and study personnel were blinded to group allocation. Perioperative care was standardized and this included spinal anesthesia and oral multimodal analgesia. The primary outcome was a multidimensional (pain, physical comfort, physical independence, emotions, and psychological support) patient-reported quality of recovery scale, QoR-15, measured on POD 1.
RESULTS


One hundred sixty patients were randomized; 6 patients were withdrawn after randomization and 2 patients had incomplete outcome data. The intention-to-treat analysis included 152 patients. The median (interquartile range [IQR]) QoR-15 score on POD 1 of the ropivacaine group was 119.5 (102-124), compared with the placebo group which had a median (IQR) of 115 (98-126). The median difference of 2 (95% confidence interval [CI], -4 to 7; P = .56) was not statistically or clinically significant. An as-per-protocol sensitivity analysis of 146 patients who received spinal anesthesia without general anesthesia, and the allocated intervention, also showed no evidence of a significant difference between groups. Secondary outcomes (worst pain numerical rating scale at rest and with movement on POD 1, opioid consumption on PODs 1 and 2, mobilization on POD 1, Brief Pain Inventory severity and interference on POD 90, and length of stay) were similar in both groups.
CONCLUSIONS


LIA with 0.2% ropivacaine when compared with 0.9% saline as placebo did not improve quality of recovery 1 day after anterior THA.",2019,"The median difference of 2 (95% confidence interval [CI], -4 to 7; P = .56) was not statistically or clinically significant.","['anterior total hip arthroplasty (THA) surgery', 'Patients scheduled to have a primary unilateral anterior THA with a single surgeon in a tertiary level metropolitan hospital', 'One hundred sixty patients', '152 patients', '146 patients who received', 'After Anterior Total Hip Arthroplasty']","['Placebo', 'Local infiltration analgesia (LIA', 'ropivacaine', 'placebo', 'spinal anesthesia without general anesthesia', 'LIA with either 2.5 mL/kg of 0.2% ropivacaine or 0.9% saline as placebo']","['quality of recovery', 'QoR-15 score', 'median (interquartile range [IQR', 'pain numerical rating scale at rest and with movement on POD 1, opioid consumption on PODs 1 and 2, mobilization on POD 1, Brief Pain Inventory severity and interference on POD 90, and length of stay', 'patient quality of recovery on postoperative day (POD', 'multidimensional (pain, physical comfort, physical independence, emotions, and psychological support) patient-reported quality of recovery scale, QoR-15, measured on POD 1', 'Quality of Recovery-15 (QoR-15) score', 'Quality of Recovery']","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0600015', 'cui_str': 'Emotional support (regime/therapy)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",160.0,0.734306,"The median difference of 2 (95% confidence interval [CI], -4 to 7; P = .56) was not statistically or clinically significant.","[{'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Tan', 'Affiliation': 'From the Department of Anaesthesia, Critical Care Institute, Epworth HealthCare, Melbourne, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gotmaker', 'Affiliation': ""Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Barrington', 'Affiliation': ""Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, Australia.""}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004255']
685,32266494,Exercise type and fat mass loss regulate breast cancer-related sex hormones in obese and overweight postmenopausal women.,"PURPOSE


The aim of the study was to examine the effects of a time-matched endurance versus concurrent training on circulating sex hormone levels and body composition in postmenopausal women.
METHODS


Thirty-five sedentary and obese postmenopausal women were recruited and randomly divided into endurance training (EN, n = 10), concurrent training (CON, n = 13), or control group (C, n = 12). Participants took part in a 12-week supervised intervention, training 3 days/week and 60 min/session. Before and after the intervention, body composition was assessed, and blood samples were obtained to evaluate estradiol, testosterone, DHEA-S, and SHBG.
RESULT


In response to training, a reduction in total fat mass was found (5.3%; P < 0.05), while an increase in lean body mass was observed in the CON group (1.5%; P < 0.05). There was a significant decrease in DHEA-S (- 13%), total (- 40%) and free testosterone (- 41%) in the EN group, while in the CON group, total (25%) and free testosterone (21%) increased significantly (P < 0.05). When participants were stratified according to fat mass loss (> or < 2 kg), a statistically significant increase in circulating SHBG (21%) and decrease in DHEA-S (- 13%) were found.
CONCLUSION


The type of exercise and exercise-induced fat mass loss seem to modify the sex hormone profile in postmenopausal women that is an established risk factor of breast cancer. Thus, this study provides additional evidences to the intricated interaction among sex hormones, adipose tissue, and muscle mass in postmenopausal women.",2020,"In response to training, a reduction in total fat mass was found (5.3%; P < 0.05), while an increase in lean body mass was observed in the CON group (1.5%; P < 0.05).","['obese and overweight postmenopausal women', 'postmenopausal women', 'Thirty-five sedentary and obese postmenopausal women']","['Exercise type and fat mass', 'endurance training (EN, n\u2009=\u200910), concurrent training (CON', 'exercise and exercise-induced fat mass loss', 'time-matched endurance versus concurrent training', 'CON']","['free testosterone', 'circulating SHBG', 'estradiol, testosterone, DHEA-S, and SHBG', 'lean body mass', 'total fat mass', 'body composition', 'DHEA-S']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]","[{'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0057277', 'cui_str': 'Dehydroepiandrosterone sulfate'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",35.0,0.0168716,"In response to training, a reduction in total fat mass was found (5.3%; P < 0.05), while an increase in lean body mass was observed in the CON group (1.5%; P < 0.05).","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Gonzalo-Encabo', 'Affiliation': 'Department of Biomedical Sciences. Faculty of Medicine and Health Sciences, University of Alcalá, Ctra. Madrid-Barcelona km 33,600, 28805, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Valadés', 'Affiliation': 'Department of Biomedical Sciences. Faculty of Medicine and Health Sciences, University of Alcalá, Ctra. Madrid-Barcelona km 33,600, 28805, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Natalio', 'Initials': 'N', 'LastName': 'García-Honduvilla', 'Affiliation': 'Department of Medicine and Medical Specialties, Faculty of Medicine and Health Sciences and Networking Biomedical Research Centre on Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), University of Alcalá, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'de Cos Blanco', 'Affiliation': 'Department of Nutrition, Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Friedenreich', 'Affiliation': 'Department of Cancer Epidemiology and Prevention Research, CancerControl Alberta, Alberta Health Services, Calgary, AB, Canada.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pérez-López', 'Affiliation': 'Department of Biomedical Sciences. Faculty of Medicine and Health Sciences, University of Alcalá, Ctra. Madrid-Barcelona km 33,600, 28805, Alcalá de Henares, Madrid, Spain. Alberto_perez-lopez@hotmail.com.'}]",European journal of applied physiology,['10.1007/s00421-020-04361-1']
686,32267168,Self-guided mindfulness and cognitive behavioural practices reduce anxiety in autistic adults: A pilot 8-month waitlist-controlled trial of widely available online tools.,"LAY ABSTRACT


Anxiety in autism is an important target for psychological therapies because it is very common and because it significantly impacts upon quality of life and well-being. Growing evidence suggests that cognitive behaviour therapies and mindfulness-based therapies can help autistic individuals learn to manage feelings of anxiety but access to such therapies remains problematic. In the current pilot study, we examined whether existing online cognitive behaviour therapy and mindfulness-based therapy self-help tools can help reduce anxiety in autistic adults. Specifically, 35 autistic adults were asked to try either an existing online cognitive behaviour therapy (n = 16) or mindfulness-based therapy (n = 19) programme while a further 19 autistic adults served as a waitlist comparison group. A first important finding was that 23 of the 35 (66%) participants who tried the online tools completed them, suggesting that such tools are, in principle, acceptable to many autistic adults. In addition, adults in the cognitive behaviour therapy and mindfulness-based therapy conditions reported significant decreases in anxiety over 3 and to some extent also 6 months that were less apparent in the waitlist group of participants. On broader measures of mental health and well-being, the benefits of the online tools were less apparent. Overall, the results suggest that online self-help cognitive behaviour therapy and mindfulness-based therapy tools should be explored further as a means of providing cost-effective mental health support to at least those autistic individuals who can engage effectively with such online tools.",2020,"On broader measures of mental health and well-being, the benefits of the online tools were less apparent.","['35 autistic adults', '19 autistic adults served as a waitlist comparison group', 'autistic adults']","['Self-guided mindfulness and cognitive behavioural practices', 'existing online cognitive behaviour therapy and mindfulness-based therapy self-help tools', 'existing online cognitive behaviour therapy (n = 16) or mindfulness-based therapy']",['anxiety'],"[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",35.0,0.0145778,"On broader measures of mental health and well-being, the benefits of the online tools were less apparent.","[{'ForeName': 'Sebastian B', 'Initials': 'SB', 'LastName': 'Gaigg', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Flaxman', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Gracie', 'Initials': 'G', 'LastName': 'McLaven', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Ritika', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Dermot M', 'Initials': 'DM', 'LastName': 'Bowler', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'University of Westminster, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Roestorf', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Haenschel', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Rodgers', 'Affiliation': 'Newcastle University, UK.'}, {'ForeName': 'Mikle', 'Initials': 'M', 'LastName': 'South', 'Affiliation': 'Brigham Young University, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361320909184']
687,31122111,Functional Exercise Improves Mobility Performance in Older Adults With Type 2 Diabetes: A Randomized Controlled Trial.,"Background : Diabetes-related disability occurs in approximately two-thirds of older adults with diabetes and is associated with loss of independence, increased health care resource utilization, and sedentary lifestyle. The objective of this randomized controlled trial was to determine the effect of a center-based functional circuit exercise training intervention followed by a 10-week customized home-based program in improving mobility function in sedentary older adults with diabetes.  Methods : Participants (n = 111; mean age 70.5 [7.1] y; mean body mass index 32.7 [5.9] kg/m 2 ) were randomized to either a moderate-intensity functional circuit training (FCT) plus 10-week home program to optimize physical activity (FCT-PA) primary intervention or one of 2 comparison groups (FCT plus health education [FCT-HE] or flexibility and toning plus health education [FT-HE]).  Results : Compared with FT-HE, FCT-PA improvements in comfortable gait speed of 0.1 m/s ( P  < .05) and 6-minute walk of 80 ft were consistent with estimates of clinically meaningful change. At 20 weeks, controlling for 10-week outcomes, improvements were found between groups for comfortable gait speed (FCT-PA vs FT-HE and FCT-HE vs FT-HE) and 6-minute walk (FCT-PA vs FCT-HE).  Conclusions : Functional exercise training can improve mobility in overweight/obese older adults with diabetes and related comorbidities. Future studies should evaluate intervention sustainability and adaptations for those with more severe mobility impairments.",2019,"Compared with FT-HE, FCT-PA improvements in comfortable gait speed of 0.1 m/s ( P  < .05) and 6-minute walk of 80 ft were consistent with estimates of clinically meaningful change.","['Older Adults With Type', 'Methods : Participants (n\u2009=\u2009111', 'mean age 70.5 [7.1', 'sedentary older adults with diabetes', 'overweight/obese older adults with diabetes and related comorbidities', 'y', '2 Diabetes']","['Functional exercise training', 'center-based functional circuit exercise training intervention', ' ', 'Functional Exercise', 'moderate-intensity functional circuit training (FCT) plus 10-week home program to optimize physical activity (FCT-PA) primary intervention or one of 2 comparison groups (FCT plus health education [FCT-HE] or flexibility and toning plus health education [FT-HE']","['mobility function', 'Mobility Performance', 'comfortable gait speed']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}]",,0.0785422,"Compared with FT-HE, FCT-PA improvements in comfortable gait speed of 0.1 m/s ( P  < .05) and 6-minute walk of 80 ft were consistent with estimates of clinically meaningful change.","[{'ForeName': 'Kimberlee A', 'Initials': 'KA', 'LastName': 'Gretebeck', 'Affiliation': ''}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Blaum', 'Affiliation': ''}, {'ForeName': 'Tisha', 'Initials': 'T', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Galecki', 'Affiliation': ''}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Strasburg', 'Affiliation': ''}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Neil B', 'Initials': 'NB', 'LastName': 'Alexander', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0240']
688,32251792,The Efficacy and Safety of High-dose Daptomycin in the Treatment of Complicated Skin and Soft Tissue Infections in Asians.,"OBJECTIVE


To compare the efficacy and safety of standard-dose (SD) daptomycin with those of high-dose (HD) daptomycin in complicated skin and soft tissue infections (cSSTIs) in an Asian population.
MATERIALS AND METHODS


Patients from three medical centers diagnosed with cSSTIs were screened in the clinical information system. Patients included in the analysis were divided into two groups: those who received daptomycin at doses ≥ 6 mg/kg (HD group) and those receiving 4 mg/kg (SD group). The demographics and clinical treatment information were analyzed.
RESULTS


Overall, 155 patients were recruited, including 108 patients in the SD group and 47 patients in the HD group. The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005). Compared with the SD group, the HD group had statistically significant early clinical stabilization (72.34% vs 52.78%, P = 0.023). The results of the multivariate analysis indicated that HD daptomycin was an independent effector for early clinical stabilization (HR=0.394, P < 0.001). The rate of drug-related adverse events was equally distributed in the HD and SD groups (36.17% vs. 26.85%, P = 0.243).
CONCLUSION


Compared with SD daptomycin, HD daptomycin increased the rate of early clinical stabilization in Asian patients with cSSTIs, whereas the incidence of adverse events did not increase.",2020,"The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005).","['complicated skin and soft tissue infections (cSSTIs) in an Asian population', '155 patients were recruited, including 108 patients in the SD group and 47 patients in the HD group', 'Patients from three medical centers diagnosed with cSSTIs were screened in the clinical information system', 'Complicated Skin and Soft Tissue Infections in Asians']","['daptomycin at doses ≥ 6\u2009mg/kg (HD group) and those receiving 4\u2009mg/kg (SD group', 'High-dose Daptomycin', 'standard-dose (SD) daptomycin with those of high-dose (HD) daptomycin']","['clinical stabilization', 'rate of early clinical stabilization', 'incidence of adverse events', 'rate of drug-related adverse events', 'rate of healthcare-associated infections', 'efficacy and safety']","[{'cui': 'C4727978', 'cui_str': 'Complicated skin and soft tissue infection'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021428', 'cui_str': 'Information system'}]","[{'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",155.0,0.0449794,"The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005).","[{'ForeName': 'Xiao-Meng', 'Initials': 'XM', 'LastName': 'Dong', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Yong-Yuan', 'Initials': 'YY', 'LastName': 'Yao', 'Affiliation': ""Department of Intensive Care Medicine, Rizhao People's Hospital, Rizhao 276800, China.""}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Guan', 'Affiliation': ""Department of Infectious Diseases, Rizhao People's Hospital, Rizhao 276800, China.""}, {'ForeName': 'Qing-Yan', 'Initials': 'QY', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Feng-Zhe', 'Initials': 'FZ', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China. Electronic address: clinicalpaper@163.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.03.060']
689,32252416,The Multispecies Probiotic Effectively Reduces Homocysteine Concentration in Obese Women: A Randomized Double-Blind Placebo-Controlled Study.,"Dysregulated metabolism of homocysteine (Hcy) is associated with obesity. Supplementation with probiotics can potentially be a natural therapeutic method for metabolic disorders. The precise mechanism in which microbiota affect Hcy metabolism in obese individuals is still unknown. The aim of this study was to evaluate the effects of a 12-week supplementation with a multispecies probiotic on Hcy levels, oxidative stress, inflammation and lipid profile in obese patients. This randomized double-blind placebo-controlled trial was performed on 50 obese women (aged 45-70 years). Subjects were randomly assigned to take either a multispecies probiotic supplement ( n  = 25) or placebo ( n  = 25) for 12 weeks. The probiotic contained nine bacterial strains containing 2.5 × 10 9  CFU/g. Biochemical and anthropometric measurements were carried out at baseline and after 12 weeks of intervention. At the end of the study, a significant decrease in Hcy, tumor necrosis factor α (TNF-α), total cholesterol (TC), low-density lipoprotein cholesterol (LDL) and triglyceride (TG) levels were observed in the probiotic group. The amelioration of total antioxidant status (TAS) was also observed. The 12-week supplementation of the multispecies probiotic (Ecologic ®  BARIER) effectively reduced Hcy concentration, oxidative stress and inflammation, and improved the lipid profile. These multidirectional effects can potentially reduce cardiometabolic risks.",2020,"At the end of the study, a significant decrease in Hcy, tumor necrosis factor α (TNF-α), total cholesterol (TC), low-density lipoprotein cholesterol (LDL) and triglyceride (TG) levels were observed in the probiotic group.","['obese patients', 'Obese Women', '50 obese women (aged 45-70 years', 'obese individuals']","['multispecies probiotic', 'placebo', 'multispecies probiotic (Ecologic ®  BARIER', 'Placebo', 'multispecies probiotic supplement']","['cardiometabolic risks', 'amelioration of total antioxidant status (TAS', 'Hcy, tumor necrosis factor α (TNF-α), total cholesterol (TC), low-density lipoprotein cholesterol (LDL) and triglyceride (TG) levels', 'Homocysteine Concentration', 'Hcy levels, oxidative stress, inflammation and lipid profile', 'Hcy concentration, oxidative stress and inflammation, and improved the lipid profile', 'Dysregulated metabolism of homocysteine (Hcy']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",50.0,0.351733,"At the end of the study, a significant decrease in Hcy, tumor necrosis factor α (TNF-α), total cholesterol (TC), low-density lipoprotein cholesterol (LDL) and triglyceride (TG) levels were observed in the probiotic group.","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Majewska', 'Affiliation': 'Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics. University of Medical Sciences in Poznań, Szamarzewskiego Str. 84, 60-569 Poznan, Poland.'}, {'ForeName': 'Matylda', 'Initials': 'M', 'LastName': 'Kręgielska-Narożna', 'Affiliation': 'Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics. University of Medical Sciences in Poznań, Szamarzewskiego Str. 84, 60-569 Poznan, Poland.'}, {'ForeName': 'Hieronim', 'Initials': 'H', 'LastName': 'Jakubowski', 'Affiliation': 'Department of Microbiology, Biochemistry and Molecular Genetics, Rutgers University, New Jersey Medical School, International Center for Public Health, 225 Warren Street, Newark, NJ 07103-3535, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Szulińska', 'Affiliation': 'Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics. University of Medical Sciences in Poznań, Szamarzewskiego Str. 84, 60-569 Poznan, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Bogdański', 'Affiliation': 'Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics. University of Medical Sciences in Poznań, Szamarzewskiego Str. 84, 60-569 Poznan, Poland.'}]",Journal of clinical medicine,['10.3390/jcm9040998']
690,31149869,Cardiometabolic Effects of a Workplace Cycling Intervention.,"BACKGROUND


In laboratory settings, cycling workstations improve cardiometabolic risk factors. Our purpose was to quantify risk factors following a cycling intervention in the workplace.
METHODS


Twenty-one office workers who sat at work ≥6 hours per day underwent baseline physiological measurements (resting blood pressure, blood lipid profile, maximum oxygen consumption [V˙O2max], body composition, and 2-h oral glucose tolerance test). Participants were randomly assigned to a 4-week intervention only group (n = 12) or a delayed intervention group (n = 9) that involved a 4-week control condition before beginning the intervention. During the intervention, participants were instructed to use the cycling device a minimum of 15 minutes per hour, which would result in a total use of ≥2 hours per day during the workday. Following the intervention, physiological measurements were repeated.
RESULTS


Participants averaged 1.77 (0.48) hours per day of cycling during the intervention with no changes in actigraphy-monitored noncycling physical activity. Four weeks of the workplace intervention increased V˙O2max (2.07 [0.44] to 2.17 [0.44] L·min-1, P < .01); end of V˙O2max test power output (166.3 [42.2] to 176.6 [46.1] W, P < .01); and high-density lipoprotein cholesterol (1.09 [0.17] to 1.17 [0.24] mmol·L-1, P = .04).
CONCLUSIONS


A stationary cycling device incorporated into a sedentary workplace for 4 weeks improves some cardiometabolic risk factors with no compensatory decrease in noncycling physical activity.",2019,Participants averaged 1.77 (0.48) hours per day of cycling during the intervention with no changes in actigraphy-monitored noncycling physical activity.,['Twenty-one office workers who sat at work ≥6\xa0hours per day'],"['delayed intervention group', 'Workplace Cycling Intervention', ' ']","['cardiometabolic risk factors', 'noncycling physical activity', 'blood pressure, blood lipid profile, maximum oxygen consumption [  V', 'high-density lipoprotein cholesterol', '˙ O 2 max  ], body composition, and 2-h oral glucose tolerance test', 'V']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0556974', 'cui_str': 'hours/day (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",,0.0359128,Participants averaged 1.77 (0.48) hours per day of cycling during the intervention with no changes in actigraphy-monitored noncycling physical activity.,"[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Peterman', 'Affiliation': ''}, {'ForeName': 'Kalee L', 'Initials': 'KL', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Rodger', 'Initials': 'R', 'LastName': 'Kram', 'Affiliation': ''}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Byrnes', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0062']
691,32253271,Intravenous Iron Dosing and Infection Risk in Patients on Hemodialysis: A Prespecified Secondary Analysis of the PIVOTAL Trial.,"BACKGROUND


Experimental and observational studies have raised concerns that giving intravenous (IV) iron to patients, such as individuals receiving maintenance hemodialysis, might increase the risk of infections. The Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial randomized 2141 patients undergoing maintenance hemodialysis for ESKD to a high-dose or a low-dose IV iron regimen, with a primary composite outcome of all-cause death, heart attack, stroke, or hospitalization for heart failure. Comparison of infection rates between the two groups was a prespecified secondary analysis.
METHODS


Secondary end points included any infection, hospitalization for infection, and death from infection; we calculated cumulative event rates for these end points. We also interrogated the interaction between iron dose and vascular access (fistula versus catheter).
RESULTS


We found no significant difference between the high-dose IV iron group compared with the lose-dose group in event rates for all infections (46.5% versus 45.5%, respectively, which represented incidences of 63.3 versus 69.4 per 100 patient years, respectively); rates of hospitalization for infection (29.6% versus 29.3%, respectively) also did not differ. We did find a significant association between risk of a first cardiovascular event and any infection in the previous 30 days. Compared with patients undergoing dialysis with an arteriovenous fistula, those doing so  via  a catheter had a higher incidence of having any infection, hospitalization for infection, or fatal infection, but IV iron dosing had no effect on these outcomes.
CONCLUSIONS


The high-dose and low-dose IV iron groups exhibited identical infection rates. Risk of a first cardiovascular event strongly associated with a recent infection.",2020,"We found no significant difference between the high-dose IV iron group compared with the lose-dose group in event rates for all infections (46.5% versus 45.5%, respectively, which represented incidences of 63.3 versus 69.4 per 100 patient years, respectively); rates of hospitalization for infection (29.6% versus 29.3%, respectively) also did not differ.","['Patients on Hemodialysis', 'Haemodialysis Patients (PIVOTAL) trial randomized 2141 patients undergoing maintenance hemodialysis for ESKD to a high-dose or a low-dose IV iron regimen, with a primary composite outcome of all-cause death, heart attack, stroke, or hospitalization for heart failure']",['Proactive IV Iron Therapy'],"['infection, hospitalization for infection, and death from infection; we calculated cumulative event rates', 'infection rates', 'incidence of having any infection, hospitalization for infection, or fatal infection', 'rates of hospitalization for infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",2141.0,0.137907,"We found no significant difference between the high-dose IV iron group compared with the lose-dose group in event rates for all infections (46.5% versus 45.5%, respectively, which represented incidences of 63.3 versus 69.4 per 100 patient years, respectively); rates of hospitalization for infection (29.6% versus 29.3%, respectively) also did not differ.","[{'ForeName': 'Iain C', 'Initials': 'IC', 'LastName': 'Macdougall', 'Affiliation': ""Department of Renal Medicine, King's College Hospital, London, United Kingdom iain.macdougall11@gmail.com.""}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust and Hull York Medical School, Hull, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'White', 'Affiliation': ""Department of Renal Medicine, King's College Hospital, London, United Kingdom.""}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Division of Cardiology and Metabolism, Department of Cardiology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Farrington', 'Affiliation': 'Lister Hospital, Stevenage, United Kingdom.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Kalra', 'Affiliation': 'Salford Royal Hospital, Salford, United Kingdom.'}, {'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Mark', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Chante', 'Initials': 'C', 'LastName': 'Reid', 'Affiliation': ""Department of Renal Medicine, King's College Hospital, London, United Kingdom.""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Robertson', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Charles R V', 'Initials': 'CRV', 'LastName': 'Tomson', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'University College London, London, United Kingdom.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Winearls', 'Affiliation': 'Oxford Kidney Unit, The Churchill, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019090972']
692,32253388,The effect of television distraction versus Tell-Show-Do as behavioral management techniques in children undergoing dental treatments.,"OBJECTIVE


Distraction is a highly acceptable technique for diverting a patient's attention from what may be perceived as an unpleasant procedure, reducing anxiety and helping the patient relax. The objective of the present study was to evaluate the effect of watching television during dental treatment on pediatric patients' anxiety and cooperation compared to the commonly used conventional Tell-Show-Do (TSD) behavioral management method.
METHOD AND MATERIALS


Sixty-nine children (mean age 6.8 years) scheduled to undergo restorative dental treatment were randomly divided into two intervention groups: a group that was managed by television distraction and a control group that was managed by TSD. During treatment, anxiety was assessed by the Facial Image Scale and cooperative behavior was assessed by the Frankl scale. Pulse rate and oxygen saturation were also measured during the treatment.
RESULTS


Compared to TSD, television distraction significantly reduced anxiety by 1.27 (95% confidence interval [CI] 0.798 to 1.744, adjusted P < .001), decreased pulse rate by 6.44 beats per minute (bpm) (95% CI 4.60 to 8.28, adjusted P < .001), and significantly increased cooperation by 1.17 (95% CI -1.318 to -1.020, adjusted P < .001). A greater effect of television distraction on reduced anxiety and increased cooperation was observed during administration of the anesthetic injection. No effect of television distraction on saturation levels was noted.
CONCLUSIONS


Television distraction is an effective method for reducing anxiety and improving cooperative behavior in children during dental treatments.",2020,"Compared to TSD, television distraction significantly reduced anxiety by 1.27 (95% confidence interval [CI] 0.798 to 1.744, adjusted P < .001), decreased pulse rate by 6.44 beats per minute (bpm) (95% CI 4.60 to 8.28, adjusted P < .001), and significantly increased cooperation by 1.17 (95% CI -1.318 to -1.020, adjusted P < .001).","['children during dental treatments', ""pediatric patients' anxiety and cooperation"", 'children undergoing dental treatments', 'Sixty-nine children (mean age 6.8 years) scheduled to undergo restorative dental treatment']","['television distraction and a control group that was managed by TSD', 'Television distraction', 'watching television', 'TSD, television distraction', 'television distraction versus Tell-Show-Do as behavioral management techniques', 'television distraction']","['Pulse rate and oxygen saturation', 'Facial Image Scale and cooperative behavior', 'anxiety', 'pulse rate', 'reduced anxiety and increased cooperation', 'saturation levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0039373', 'cui_str': 'Tay-Sachs disease'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009964', 'cui_str': 'Cooperative Behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",69.0,0.0618737,"Compared to TSD, television distraction significantly reduced anxiety by 1.27 (95% confidence interval [CI] 0.798 to 1.744, adjusted P < .001), decreased pulse rate by 6.44 beats per minute (bpm) (95% CI 4.60 to 8.28, adjusted P < .001), and significantly increased cooperation by 1.17 (95% CI -1.318 to -1.020, adjusted P < .001).","[{'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Kharouba', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Peretz', 'Affiliation': ''}, {'ForeName': 'Sigalit', 'Initials': 'S', 'LastName': 'Blumer', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44366']
693,32253065,Complementary Saphenous Nerve Block to Intra-Articular Analgesia Reduces Pain After Total Knee Arthroplasty: A Prospective Randomized Controlled Trial.,"BACKGROUND


Numerous strategies exist for pain management after total knee arthroplasty (TKA), with a fast recovery and early ambulation required for full function. Currently, there is no universal standard of care to facilitate this management. We assessed pain management safety and efficacy after TKA, using intra-articular infiltration associated with peripheral saphenous nerve block (SNB) vs intra-articular infiltration alone.
METHODS


We performed a controlled, double-blinded, and randomized trial to evaluate postoperative pain in TKA. One group was treated with intra-articular analgesia associated with SNB, whereas a second group received the same intra-articular cocktail, associated with placebo. Efficacy was evaluated according to average pain, pain-free time, and morphine rescue indices. Safety was assessed by intervention complications and surgery.
RESULTS


About 70 patients were recruited. At time 0 (immediately postoperative), 51.43% of the intra-articular analgesia + placebo group presented pain <3, whereas in the intra-articular analgesia + SNB group, 8.82% (P = .001) presented with pain. This difference was maintained at 6, 12, and 24 hours, postoperatively. After 24 hours, the placebo group received an average 0.66 morphine rescues (standard deviation, 0.86), when compared with the SNB group that received 0.14 rescues (standard deviation, 0.43), (P = .002). We recorded a paresis of the external popliteal sciatic nerve, with spontaneous recovery without other complications.
CONCLUSION


Complementary SNB to intra-articular analgesia was more effective in reducing average pain and the amount of pain-free time in the first 24 hours after TKA, with fewer requests for morphine rescue analgesia.",2020,"After 24 hours, the placebo group received an average 0.66 morphine rescues (standard deviation, 0.86), when compared with the SNB group that received 0.14 rescues (standard deviation, 0.43), (P = .002).","['After Total Knee Arthroplasty', 'pain management after total knee arthroplasty (TKA', '70 patients were recruited']","['Complementary Saphenous Nerve Block to Intra-Articular Analgesia', 'placebo', 'peripheral saphenous nerve block (SNB) vs intra-articular infiltration alone']","['average pain, pain-free time, and morphine rescue indices', 'Pain', 'pain management safety and efficacy', 'Efficacy', 'Safety', 'average pain and the amount of pain-free time', 'pain <3']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0394744', 'cui_str': 'Local anesthetic saphenous nerve block'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",70.0,0.406561,"After 24 hours, the placebo group received an average 0.66 morphine rescues (standard deviation, 0.86), when compared with the SNB group that received 0.14 rescues (standard deviation, 0.43), (P = .002).","[{'ForeName': 'Tomas I', 'Initials': 'TI', 'LastName': 'Nicolino', 'Affiliation': 'Institute of Orthopaedics ""Carlos E. Ottolenghi"", Italian Hospital of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Costantini', 'Affiliation': 'Institute of Orthopaedics ""Carlos E. Ottolenghi"", Italian Hospital of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Lisandro', 'Initials': 'L', 'LastName': 'Carbó', 'Affiliation': 'Institute of Orthopaedics ""Carlos E. Ottolenghi"", Italian Hospital of Buenos Aires, Buenos Aires, Argentina.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.03.010']
694,32047925,The effect of legume supplementation on the gut microbiota in rural Malawian infants aged 6 to 12 months.,"BACKGROUND


Common bean and cowpea contain about 25% protein and 25% fiber, and are recommended as complementary foods in sub-Saharan Africa.
OBJECTIVE


The objective of this study was to determine if a daily legume supplement given to Malawian infants aged 6 to 12 mo alters the 16S configuration of the fecal microbiota as read out by amplicon sequence variants (ASVs).
METHODS


This study was conducted within the context of a randomized, double-blind, controlled clinical trial to assess whether cowpea or common bean supplementation reduced intestinal permeability or increased linear growth. There were 2 village clusters in which the study was conducted. Fresh stool collections were flash frozen from 236 infants at ≤6 time points. The stools were sequenced using Earth Microbiome project protocols and data were processed using Qiime and Qiita, open-source, validated software packages. α-diversity was measured using the Faith's test. The 16S configuration was characterized by determining the weighted UniFrac distances of the ASVs and comparing them using permutational multivariate ANOVA.
RESULTS


Among the 1249 samples analyzed, the α-diversity of the fecal microbiome was unchanged among subjects after initiation of legume supplementation. Neither cowpea nor common bean altered the overall 16S configuration at any age. The 16S configuration differed between children with adequate and poor linear growth aged from 6 to 9 mo, but no specific ASVs differed in relative abundance. The 16S configuration differed between children with normal and abnormal intestinal permeability at 9 mo, but no specific ASVs differed in relative abundance. Among categorical characteristics of the population associated with different 16S configurations, village cluster was most pronounced.
CONCLUSION


Legume supplementation in breastfed, rural African infants did not affect the structure of the gut microbial communities until the children were aged 9 mo. This trial was registered at clinicaltrials.gov as NCT02472262.",2020,"Among the 1249 samples analyzed, the α-diversity of the fecal microbiome was unchanged among subjects after initiation of legume supplementation.","['rural Malawian infants aged 6 to 12 months', 'Malawian infants aged 6 to 12 mo alters the 16S configuration of the fecal microbiota as read out by amplicon sequence variants (ASVs', 'breastfed, rural African infants']","['legume supplementation', 'Legume supplementation', 'cowpea or common bean supplementation']","['intestinal permeability', 'abnormal intestinal permeability', 'gut microbiota', 'α-diversity', 'α-diversity of the fecal microbiome']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}]","[{'cui': 'C0453184', 'cui_str': 'Legumes'}, {'cui': 'C0996862', 'cui_str': 'Vigna'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0004896', 'cui_str': 'Bean (substance)'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}]",,0.255769,"Among the 1249 samples analyzed, the α-diversity of the fecal microbiome was unchanged among subjects after initiation of legume supplementation.","[{'ForeName': 'M Isabel', 'Initials': 'MI', 'LastName': 'Ordiz', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssen', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Humphrey', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Ackermann', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Stephenson', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Agapova', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Divala', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Malawi.'}, {'ForeName': 'Yankho', 'Initials': 'Y', 'LastName': 'Kaimila', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Malawi.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Malawi.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Zhong', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Indi', 'Initials': 'I', 'LastName': 'Trehan', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Phillip I', 'Initials': 'PI', 'LastName': 'Tarr', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Brigida', 'Initials': 'B', 'LastName': 'Rusconi', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Manary', 'Affiliation': 'Department of Pediatrics, Washington University at St. Louis, St. Louis, MO, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa011']
695,32091599,A randomized clinical trial of the effects of leafy green vegetables and inorganic nitrate on blood pressure.,"BACKGROUND


A diet rich in fruits and vegetables is associated with lowering of blood pressure (BP), but the nutrient(s) responsible for these effects remain unclear. Research suggests that inorganic nitrate present in leafy green vegetables is converted into NO in vivo to improve cardiovascular function.
OBJECTIVE


In this study, we evaluated the effect of leafy green vegetables on BP in subjects with elevated BP, with the aim of elucidating if any such effect is related to their high nitrate content.
DESIGN


We enrolled 243 subjects, 50-70 y old, with a clinic systolic BP (SBP) of 130-159 mm Hg. After a 2-wk run-in period on a nitrate-restricted diet the subjects were randomly assigned to receive 1 of the following 3 interventions daily for 5 wk: low-nitrate vegetables + placebo pills, low-nitrate vegetables + nitrate pills (300 mg nitrate), or leafy green vegetables containing 300 mg nitrate + placebo pills. The primary end point measure was the difference in change in 24 h ambulatory SBP between the groups.
RESULTS


A total of 231 subjects (95%) completed the study. The insignificant change in ambulatory SBP (mean ± standard deviation) was -0.6 ± 6.2 mm Hg in the placebo group, -1.2 ± 6.8 mm Hg in the potassium nitrate group, and -0.5 ± 6.6 mm Hg in the leafy green vegetable group. There was no significant difference in change between the 3 groups.
CONCLUSIONS


A 5-wk dietary supplementation with leafy green vegetables or pills containing the same amount of inorganic nitrate does not decrease ambulatory SBP in subjects with elevated BP. This trial was registered at clinicaltrials.gov as NCT02916615.",2020,"There was no significant difference in change between the 3 groups.
","['subjects with elevated BP', '231 subjects (95%) completed the study', 'We enrolled 243 subjects, 50-70 y old, with a clinic systolic BP (SBP) of 130-159\xa0mm Hg']","['low-nitrate vegetables\xa0+\xa0placebo pills, low-nitrate vegetables\xa0+\xa0nitrate pills (300\xa0mg nitrate), or leafy green vegetables containing 300\xa0mg nitrate\xa0+\xa0placebo pills', 'placebo', 'leafy green vegetables', 'leafy green vegetables and inorganic nitrate']","['ambulatory SBP (mean ± standard deviation', 'change in 24\xa0h ambulatory SBP', 'blood pressure (BP', 'blood pressure', 'ambulatory SBP']","[{'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",243.0,0.154485,"There was no significant difference in change between the 3 groups.
","[{'ForeName': 'Michaela L', 'Initials': 'ML', 'LastName': 'Sundqvist', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Filip J', 'Initials': 'FJ', 'LastName': 'Larsen', 'Affiliation': 'Department of Sport and Health Sciences, Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Carlström', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bottai', 'Affiliation': 'Division of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pernow', 'Affiliation': 'Department of Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Mai-Lis', 'Initials': 'ML', 'LastName': 'Hellénius', 'Affiliation': 'Department of Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Weitzberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jon O', 'Initials': 'JO', 'LastName': 'Lundberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa024']
696,32097450,"Effects of whole-grain wheat, rye, and lignan supplementation on cardiometabolic risk factors in men with metabolic syndrome: a randomized crossover trial.","BACKGROUND


A whole-grain (WG)-rich diet has shown to have potential for both prevention and treatment of the metabolic syndrome (MetS), which is a cluster of risk factors that increase the risk of type 2 diabetes and cardiovascular disease. Different WGs may have different health effects. WG rye, in particular, may improve glucose homeostasis and blood lipids, possibly mediated through fermentable dietary fiber and lignans. Recent studies have also suggested a crucial role of the gut microbiota in response to WG.
OBJECTIVES


The aim was to investigate WG rye, alone and with lignan supplements [secoisolariciresinol diglucoside (SDG)], and WG wheat diets on glucose tolerance [oral-glucose-tolerance test (OGTT)], other cardiometabolic outcomes, enterolignans, and microbiota composition. Moreover, we exploratively evaluated the role of gut microbiota enterotypes in response to intervention diets.
METHODS


Forty men with MetS risk profile were randomly assigned to WG diets in an 8-wk crossover study. The rye diet was supplemented with 280 mg SDG at weeks 4-8. Effects of treatment were evaluated by mixed-effects modeling, and effects on microbiota composition and the role of gut microbiota as a predictor of response to treatment were analyzed by random forest plots.
RESULTS


The WG rye diet (± SDG supplements) did not affect the OGTT compared with WG wheat. Total and LDL cholesterol were lowered (-0.06 and -0.09 mmol/L, respectively; P < 0.05) after WG rye compared with WG wheat after 4 wk but not after 8 wk. WG rye resulted in higher abundance of Bifidobacterium [fold-change (FC) = 2.58, P < 0.001] compared with baseline and lower abundance of Clostridium genus compared with WG wheat (FC = 0.54, P = 0.02). The explorative analyses suggest that baseline enterotype is associated with total and LDL-cholesterol response to diet.
CONCLUSIONS


WG rye, alone or with SDG supplementation, compared with WG wheat did not affect glucose metabolism but caused transient LDL-cholesterol reduction. The effect of WG diets appeared to differ according to enterotype. This trial was registered at www.clinicaltrials.gov as NCT02987595.",2020,"Total and LDL cholesterol were lowered (-0.06 and -0.09 mmol/L, respectively; P < 0.05) after WG rye compared with WG wheat after 4 wk but not after 8 wk.","['Forty men with MetS risk profile', 'men with metabolic syndrome']","['WG)-rich diet', 'lignan supplements [secoisolariciresinol diglucoside (SDG', 'WG rye, alone or with SDG supplementation', 'whole-grain ', 'whole-grain wheat, rye, and lignan supplementation']","['glucose metabolism', 'glucose homeostasis and blood lipids', 'cardiometabolic risk factors', 'Total and LDL cholesterol', 'transient LDL-cholesterol reduction', 'glucose tolerance [oral-glucose-tolerance test (OGTT)], other cardiometabolic outcomes, enterolignans, and microbiota composition', 'total and LDL-cholesterol response', 'higher abundance of Bifidobacterium [fold-change (FC']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0064971', 'cui_str': 'Lignans'}, {'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C1140674', 'cui_str': 'Rye'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",40.0,0.116774,"Total and LDL cholesterol were lowered (-0.06 and -0.09 mmol/L, respectively; P < 0.05) after WG rye compared with WG wheat after 4 wk but not after 8 wk.","[{'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Eriksen', 'Affiliation': 'Department of Molecular Sciences, Swedish University of Agricultural Sciences, Uppsala, Sweden.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Brunius', 'Affiliation': 'Division of Food and Nutrition Science, Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mazidi', 'Affiliation': 'Division of Food and Nutrition Science, Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Per M', 'Initials': 'PM', 'LastName': 'Hellström', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Risérus', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Kia N', 'Initials': 'KN', 'LastName': 'Iversen', 'Affiliation': 'Division of Food and Nutrition Science, Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Fristedt', 'Affiliation': 'Division of Food and Nutrition Science, Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Molecular Sciences, Swedish University of Agricultural Sciences, Uppsala, Sweden.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Animal Nutrition and Management, Swedish University of Agricultural Sciences, Uppsala, Sweden.'}, {'ForeName': 'Natalja P', 'Initials': 'NP', 'LastName': 'Nørskov', 'Affiliation': 'Department of Animal Science, Aarhus University, Tjele, Denmark.'}, {'ForeName': 'Knud Erik B', 'Initials': 'KEB', 'LastName': 'Knudsen', 'Affiliation': 'Department of Animal Science, Aarhus University, Tjele, Denmark.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Kyrø', 'Affiliation': 'Unit of Diet, Genes and Environment, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Olsen', 'Affiliation': 'Unit of Diet, Genes and Environment, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tjønneland', 'Affiliation': 'Unit of Diet, Genes and Environment, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Dicksved', 'Affiliation': 'Department of Animal Nutrition and Management, Swedish University of Agricultural Sciences, Uppsala, Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Landberg', 'Affiliation': 'Division of Food and Nutrition Science, Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa026']
697,32255395,Subacute effects of the psychedelic ayahuasca on the salience and default mode networks.,"BACKGROUND


Neuroimaging studies have just begun to explore the acute effects of psychedelics on large-scale brain networks' functional organization. Even less is known about the neural correlates of subacute effects taking place days after the psychedelic experience. This study explores the subacute changes of primary sensory brain networks and networks supporting higher-order affective and self-referential functions 24 hours after a single session with the psychedelic ayahuasca.
METHODS


We leveraged task-free functional magnetic resonance imaging data 1 day before and 1 day after a randomized placebo-controlled trial exploring the effects of ayahuasca in naïve healthy participants (21 placebo/22 ayahuasca). We derived intra- and inter-network functional connectivity of the salience, default mode, visual, and sensorimotor networks, and assessed post-session connectivity changes between the ayahuasca and placebo groups. Connectivity changes were associated with Hallucinogen Rating Scale scores assessed during the acute effects.
RESULTS


Our findings revealed increased anterior cingulate cortex connectivity within the salience network, decreased posterior cingulate cortex connectivity within the default mode network, and increased connectivity between the salience and default mode networks 1 day after the session in the ayahuasca group compared to placebo. Connectivity of primary sensory networks did not differ between groups. Salience network connectivity increases correlated with altered somesthesia scores, decreased default mode network connectivity correlated with altered volition scores, and increased salience default mode network connectivity correlated with altered affect scores.
CONCLUSION


These findings provide preliminary evidence for subacute functional changes induced by the psychedelic ayahuasca on higher-order cognitive brain networks that support interoceptive, affective, and self-referential functions.",2020,"Salience network connectivity increases correlated with altered somesthesia scores, decreased default mode network connectivity correlated with altered volition scores, and increased salience default mode network connectivity correlated with altered affect scores.
",['naïve healthy participants (21 placebo/22 ayahuasca'],"['ayahuasca', 'psychedelic ayahuasca', 'placebo']","['anterior cingulate cortex connectivity', 'Hallucinogen Rating Scale scores', 'altered somesthesia scores', 'posterior cingulate cortex connectivity', 'salience default mode network connectivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}]","[{'cui': 'C0330913', 'cui_str': 'Banisteriopsis'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0018533', 'cui_str': 'Hallucinogen'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234209', 'cui_str': 'Somatic sensation'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",,0.144697,"Salience network connectivity increases correlated with altered somesthesia scores, decreased default mode network connectivity correlated with altered volition scores, and increased salience default mode network connectivity correlated with altered affect scores.
","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Pasquini', 'Affiliation': 'Memory and Aging Center, University of California, San Francisco, United States of America.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Palhano-Fontes', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal-RN, Brazil.'}, {'ForeName': 'Draulio B', 'Initials': 'DB', 'LastName': 'Araujo', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte, Natal-RN, Brazil.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120909409']
698,31483448,Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial.,"Importance


The patterns of disease recurrence after resection of pancreatic ductal adenocarcinoma with adjuvant chemotherapy remain unclear.
Objective


To define patterns of recurrence after adjuvant chemotherapy and the association with survival.
Design, Setting, and Participants


Prospectively collected data from the phase 3 European Study Group for Pancreatic Cancer 4 adjuvant clinical trial, an international multicenter study. The study included 730 patients who had resection and adjuvant chemotherapy for pancreatic cancer. Data were analyzed between July 2017 and May 2019.
Interventions


Randomization to adjuvant gemcitabine or gemcitabine plus capecitabine.
Main Outcomes and Measures


Overall survival, recurrence, and sites of recurrence.
Results


Of the 730 patients, median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43%). The median follow-up time from randomization was 43.2 months (95% CI, 39.7-45.5 months), with overall survival from time of surgery of 27.9 months (95% CI, 24.8-29.9 months) with gemcitabine and 30.2 months (95% CI, 25.8-33.5 months) with the combination (HR, 0.81; 95% CI, 0.68-0.98; P = .03). The 5-year survival estimates were 17.1% (95% CI, 11.6%-23.5%) and 28.0% (22.0%-34.3%), respectively. Recurrence occurred in 479 patients (65.6%); another 78 patients (10.7%) died without recurrence. Local recurrence occurred at a median of 11.63 months (95% CI, 10.05-12.19 months), significantly different from those with distant recurrence with a median of 9.49 months (95% CI, 8.44-10.71 months) (HR, 1.21; 95% CI, 1.01-1.45; P = .04). Following recurrence, the median survival was 9.36 months (95% CI, 8.08-10.48 months) for local recurrence and 8.94 months (95% CI, 7.82-11.17 months) with distant recurrence (HR, 0.89; 95% CI, 0.73-1.09; P = .27). The median overall survival of patients with distant-only recurrence (23.03 months; 95% CI, 19.55-25.85 months) or local with distant recurrence (23.82 months; 95% CI, 17.48-28.32 months) was not significantly different from those with only local recurrence (24.83 months; 95% CI, 22.96-27.63 months) (P = .85 and P = .35, respectively). Gemcitabine plus capecitabine had a 21% reduction of death following recurrence compared with monotherapy (HR, 0.79; 95% CI, 0.64-0.98; P = .03).
Conclusions and Relevance


There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence. Pancreatic cancer behaves as a systemic disease requiring effective systemic therapy after resection.
Trial Registration


ClinicalTrials.gov identifier: NCT00058201, EudraCT 2007-004299-38, and ISRCTN 96397434.",2019,"Conclusions and Relevance


There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence.","[' median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43', '730 patients who had resection and adjuvant chemotherapy for pancreatic cancer', 'Pancreatic Ductal Adenocarcinoma', '730 patients']","['Gemcitabine plus capecitabine', 'gemcitabine', 'gemcitabine or gemcitabine plus capecitabine']","['local recurrence', 'median overall survival', 'Measures\n\n\nOverall survival, recurrence, and sites of recurrence', 'overall survival', 'median survival', 'death following recurrence', 'local with distant recurrence', 'time to recurrence and subsequent and overall survival', 'Recurrence', 'distant recurrence', 'median follow-up time', 'Local recurrence', '5-year survival estimates']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517771', 'cui_str': 'Four hundred and fourteen'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",730.0,0.440122,"Conclusions and Relevance


There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence.","[{'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Jones', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Eftychia-Eirini', 'Initials': 'EE', 'LastName': 'Psarelli', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ghaneh', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Halloran', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Campbell', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'University of Manchester/The Christie, Manchester, England.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Faluyi', 'Affiliation': 'The Clatterbridge Cancer Centre, Wirral, England.'}, {'ForeName': 'Derek A', 'Initials': 'DA', 'LastName': ""O'Reilly"", 'Affiliation': 'Manchester University Foundation Trust, Manchester, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden Hospital, London, England.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Weston Park Hospital, Sheffield, England.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Darby', 'Affiliation': 'Weston Park Hospital, Sheffield, England.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Royal Free Hospital, London, England.'}, {'ForeName': 'Roopinder', 'Initials': 'R', 'LastName': 'Gillmore', 'Affiliation': 'Royal Free Hospital, London, England.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Anthoney', 'Affiliation': ""St. James's University Hospital, Leeds, England.""}, {'ForeName': 'Pehr', 'Initials': 'P', 'LastName': 'Lind', 'Affiliation': 'Clinical Research Sörmland, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Clinical Research Sörmland, University of Uppsala, Uppsala, Sweden.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Haematology and Oncology Centre, Bristol, England.'}, {'ForeName': 'Jakob R', 'Initials': 'JR', 'LastName': 'Izbicki', 'Affiliation': 'University of Hamburg Medical Institutions UKE, Hamburg, Germany.'}, {'ForeName': 'Gary William', 'Initials': 'GW', 'LastName': 'Middleton', 'Affiliation': 'Royal Surrey County Hospital, Guildford, England.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Cummins', 'Affiliation': 'Royal Surrey County Hospital, Guildford, England.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Ross', 'Affiliation': ""Guy's Hospital, London, England.""}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, London, England.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'The Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Crosby', 'Affiliation': 'Velindre Hospital, Cardiff, Wales.'}, {'ForeName': 'Yuk', 'Initials': 'Y', 'LastName': 'Ting', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, England.'}, {'ForeName': 'Kinnari', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Churchill Hospital, Oxford, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sherriff', 'Affiliation': 'Derriford Hospital, Plymouth, England.'}, {'ForeName': 'Rubin', 'Initials': 'R', 'LastName': 'Soomal', 'Affiliation': 'Jersey General Hospital, Jersey, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Borg', 'Affiliation': 'Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Sothi', 'Affiliation': 'University Hospital Coventry, Coventry, England.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'Markus M', 'Initials': 'MM', 'LastName': 'Lerch', 'Affiliation': 'Greifswald University, Medicine, Greifswald, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mayerle', 'Affiliation': 'Greifswald University, Medicine, Greifswald, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tjaden', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Strobel', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Neoptolemos', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2019.3337']
699,32083646,Exopolysaccharides from milk fermented by lactic acid bacteria enhance dietary carotenoid bioavailability in humans in a randomized crossover trial and in rats.,"BACKGROUND


Dietary supplementation with carotenoids can have beneficial health effects, but carotenoids are poorly absorbed.
OBJECTIVES


We aimed to evaluate how milk fermented by lactic acid bacteria affects dietary carotenoid bioavailability in humans and rats and to investigate mechanisms by which active components in milk fermented by Lactobacilli enhance dietary carotenoid absorption.
METHODS


Male rats (n = 8/group) were administered β-carotene or β-carotene + fermented milk. Rats (n = 6/group) were also pretreated with ezetimibe, a cholesterol absorption inhibitor, to investigate β-carotene transport mechanisms. In humans, 3 studies were conducted using a randomized crossover method. Subjects (n = 16/study) consumed a vegetable (carrot, tomato, or spinach) drink alone or with a fermented milk drink. Blood samples were collected at various time points after consumption.
RESULTS


In rats, the serum β-carotene area under the concentration-time curve (AUC) was significantly higher for the β-carotene + fermented milk than for β-carotene only. A significant correlation (r = 0.83, P < 0.001) between the exopolysaccharide (EPS) content of fermented milk and serum β-carotene AUC was observed. Ezetimibe treatment did not suppress elevations in serum β-carotene concentrations induced by fermented milk ingestion. In humans, the incremental area under the concentration-time curve (iAUC) for β-carotene in the plasma triacylglycerol-rich lipoprotein (TRL) fraction was significantly (1.8-fold, range: 0.6-3.9) higher when carrot + fermented milk was consumed compared with carrot drink alone. A significantly (6.5-fold, range: 0.04-7.7) higher iAUC for lycopene in the plasma TRL fraction was observed for subjects who consumed tomato + fermented milk compared with tomato drink alone. A significant increase in plasma lutein in all fractions was observed after consumption of spinach + fermented milk, but not with spinach drink alone.
CONCLUSIONS


Co-ingestion of β-carotene and fermented milk significantly increased dietary β-carotene bioavailability in humans and rats. EPSs could affect the physical properties of fermented milk to enhance dietary β-carotene absorption mediated by simple diffusion mechanisms. These findings may be relevant for methods to increase dietary carotenoid bioavailability.This trial was registered at umin.ac.jp/ctr as UMIN000034838, UMIN000034839, and UMIN000034840.",2020,"In rats, the serum β-carotene area under the concentration-time curve (AUC) was significantly higher for the β-carotene + fermented milk than for β-carotene only.","['Male rats (n\xa0=\xa08/group', 'Subjects (n\xa0', 'Rats (n\xa0', 'humans and rats']","['β-carotene and fermented milk', 'Ezetimibe', 'ezetimibe', 'β-carotene or β-carotene\xa0+\xa0fermented milk', 'milk fermented by lactic acid bacteria', 'vegetable (carrot, tomato, or spinach) drink alone or with a fermented milk drink', 'Exopolysaccharides from milk fermented by lactic acid bacteria']","['plasma lutein', 'serum β-carotene concentrations', 'exopolysaccharide (EPS) content of fermented milk and serum β-carotene AUC', 'serum β-carotene area under the concentration-time curve (AUC', 'dietary carotenoid bioavailability', 'plasma TRL fraction', 'plasma triacylglycerol-rich lipoprotein (TRL) fraction', 'dietary β-carotene bioavailability']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1210581', 'cui_str': 'Lactic Acid Bacteria'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C1141640', 'cui_str': 'Carrots'}, {'cui': 'C1140676', 'cui_str': 'Solanum lycopersicum'}, {'cui': 'C0242949', 'cui_str': 'Spinach'}, {'cui': 'C0556317', 'cui_str': 'Drinks alone (finding)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}]",,0.0225199,"In rats, the serum β-carotene area under the concentration-time curve (AUC) was significantly higher for the β-carotene + fermented milk than for β-carotene only.","[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Morifuji', 'Affiliation': 'Food Microbiology Research Labs, Meiji Co., Ltd., Meiji Innovation Center, Hachiouji, Tokyo, Japan.'}, {'ForeName': 'Satomi', 'Initials': 'S', 'LastName': 'Ichikawa', 'Affiliation': 'Food Microbiology Research Labs, Meiji Co., Ltd., Meiji Innovation Center, Hachiouji, Tokyo, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Kitade', 'Affiliation': 'Food Microbiology Research Labs, Meiji Co., Ltd., Meiji Innovation Center, Hachiouji, Tokyo, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Fukasawa', 'Affiliation': 'Food Microbiology Research Labs, Meiji Co., Ltd., Meiji Innovation Center, Hachiouji, Tokyo, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Asami', 'Affiliation': 'Food Microbiology Research Labs, Meiji Co., Ltd., Meiji Innovation Center, Hachiouji, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Manabe', 'Affiliation': 'Division of Applied Biosciences, Graduate School of Agriculture, Kyoto University, Sakyo-ku, Kyoto, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Sugawara', 'Affiliation': 'Division of Applied Biosciences, Graduate School of Agriculture, Kyoto University, Sakyo-ku, Kyoto, Japan.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa020']
700,30586008,Haptoglobin 2 Allele is Associated With Histologic Response to Vitamin E in Subjects With Nonalcoholic Steatohepatitis.,"BACKGROUND


Haptoglobin (Hp) genotype has been linked to oxidative stress and cardiovascular outcomes in response to vitamin E (VitE) among patients with diabetes mellitus. Its effect on histologic response to VitE in nonalcoholic steatohepatitis (NASH) is unknown.
GOALS


Our objective was to determine if Hp genotype associates with response to VitE in patients with NASH.
STUDY


A post hoc analysis of 228 patients receiving VitE or placebo in 2 clinical trials was performed. Regression analysis was used to assess the effect of VitE versus placebo, by Hp genotype (1-1, 2-1, or 2-2), on histologic features and laboratory markers of nonalcoholic fatty liver disease, comparing baseline to end of treatment values. An interaction term was included in the regression models to assess differential treatment effect across Hp genotype.
RESULTS


Hp 2-2 patients treated with VitE versus placebo showed significant histologic improvement (51% vs. 20%; OR=4.2; P=0.006), resolution of steatohepatitis (44% vs. 12%; OR=6.2; P=0.009), decrease in nonalcoholic fatty liver disease Activity Score (NAS) (-2.2 vs. -0.6; P=0.001), and decrease in liver enzymes alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and γ-glutamyl transpeptidase. Hp 2-1 patients on VitE versus placebo showed improved resolution of steatohepatitis, NAS and liver enzymes. Hp 1-1 patients showed no significant improvement in histology or liver enzymes. VitE had no effect on fibrosis stage in any group. Regression analysis showed incremental benefit of having Hp 2-2 or 2-1 versus 1-1 for all liver enzyme.
CONCLUSIONS


Hp 2 allele is associated with greater histologic and biological improvement in NASH with VitE treatment compared with the Hp 1 allele.",2019,"Hp 2-1 patients on VitE versus placebo showed improved resolution of steatohepatitis, NAS and liver enzymes.","['patients with NASH', '228 patients receiving VitE or', 'patients with diabetes mellitus', 'Subjects With Nonalcoholic Steatohepatitis']","['vitamin E (VitE', 'VitE versus placebo', 'Vitamin E', 'placebo']","['resolution of steatohepatitis, NAS and liver enzymes', 'nonalcoholic fatty liver disease Activity Score (NAS', 'histology or liver enzymes', 'fibrosis stage', 'histologic improvement', 'resolution of steatohepatitis', 'liver enzymes alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and γ-glutamyl transpeptidase']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0017040', 'cui_str': 'gammaglutamyltransferase'}]",228.0,0.342091,"Hp 2-1 patients on VitE versus placebo showed improved resolution of steatohepatitis, NAS and liver enzymes.","[{'ForeName': 'Bubu A', 'Initials': 'BA', 'LastName': 'Banini', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Sophie C', 'Initials': 'SC', 'LastName': 'Cazanave', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Katherine P', 'Initials': 'KP', 'LastName': 'Yates', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Amon', 'Initials': 'A', 'LastName': 'Asgharpour', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vincent', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Faridoddin', 'Initials': 'F', 'LastName': 'Mirshahi', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Le', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Contos', 'Affiliation': 'Division of Surgical Pathology, Department of Pathology, VCU School of Medicine, Richmond, VA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Naga P', 'Initials': 'NP', 'LastName': 'Chalasani', 'Affiliation': 'Division of Gastroenterology and Hepatology, Indiana Fatty Liver Disease Research Group, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Liver Care Network, Swedish Medical Center, Seattle, WA.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'McCullough', 'Affiliation': 'Department of Gastroenterology and Hepatology, Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Behling', 'Affiliation': 'Department of Pathology, Sharp Health System.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Schwimmer', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California, San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Lavine', 'Affiliation': 'Department of Pediatrics, Columbia University, New York, NY.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001142']
701,31178434,Lack of Durable Improvements in β-Cell Function Following Withdrawal of Pharmacological Interventions in Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes.,"OBJECTIVE


The Restoring Insulin Secretion (RISE) Adult Medication Study compared pharmacological approaches targeted to improve β-cell function in individuals with impaired glucose tolerance (IGT) or treatment-naive type 2 diabetes of <12 months duration.
RESEARCH DESIGN AND METHODS


A total of 267 adults with IGT ( n  = 197, 74%) or recently diagnosed type 2 diabetes ( n  = 70, 26%) were studied. Participants were randomized to receive 12 months of metformin alone, 3 months of insulin glargine with a target fasting glucose <5 mmol/L followed by 9 months of metformin, 12 months of liraglutide combined with metformin, or 12 months of placebo. β-Cell function was assessed using hyperglycemic clamps at baseline, 12 months (on treatment), and 15 months (3 months off treatment). The primary outcome was β-cell function at 15 months compared with baseline.
RESULTS


All three active treatments produced on-treatment reductions in weight and improvements in HbA 1c  compared with placebo; the greatest reductions were seen in the liraglutide plus metformin group. At 12 months, glucose-stimulated C-peptide responses improved in the three active treatment groups and were greatest in the liraglutide plus metformin group, but the arginine-stimulated incremental C-peptide response was reduced in the liraglutide plus metformin group. Despite on-treatment benefits, 3 months after treatment withdrawal there were no sustained improvements in β-cell function in any treatment group.
CONCLUSIONS


In adults with IGT or recently diagnosed type 2 diabetes, interventions that improved β-cell function during active treatment failed to produce persistent benefits after treatment withdrawal. These observations suggest that continued intervention may be required to alter the progressive β-cell dysfunction in IGT or early type 2 diabetes.",2019,"At 12 months, glucose-stimulated C-peptide responses improved in the three active treatment groups and were greatest in the liraglutide plus metformin group, but the arginine-stimulated incremental C-peptide response was reduced in the liraglutide plus metformin group.","['Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes', 'individuals with impaired glucose tolerance (IGT) or treatment-naive type 2 diabetes of <12 months duration', '267 adults with IGT ( n  = 197, 74%) or recently diagnosed type 2 diabetes ( n  = 70, 26%) were studied']","['liraglutide combined with metformin', 'placebo', 'insulin glargine with a target fasting glucose <5 mmol/L followed by 9 months of metformin', 'metformin', 'liraglutide plus metformin']","['Restoring Insulin Secretion (RISE', 'β-cell function', 'weight and improvements in HbA 1c', 'arginine-stimulated incremental C-peptide response', 'glucose-stimulated C-peptide responses', 'β-Cell function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",267.0,0.0446286,"At 12 months, glucose-stimulated C-peptide responses improved in the three active treatment groups and were greatest in the liraglutide plus metformin group, but the arginine-stimulated incremental C-peptide response was reduced in the liraglutide plus metformin group.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0556']
702,31186300,PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes.,"OBJECTIVE


This trial compared the efficacy and safety of the first oral glucagon-like peptide 1 (GLP-1) receptor agonist, oral semaglutide, as monotherapy with placebo in patients with type 2 diabetes managed by diet and exercise alone. Two estimands addressed two efficacy-related questions: a treatment policy estimand (regardless of trial product discontinuation or rescue medication use) and a trial product estimand (on trial product without rescue medication use) in all randomized patients.
RESEARCH DESIGN AND METHODS


This was a 26-week, phase 3a, randomized, double-blind, placebo-controlled, parallel-group trial conducted in 93 sites in nine countries. Adults with type 2 diabetes insufficiently controlled with diet and exercise were randomized (1:1:1:1) to once-daily oral semaglutide 3 mg, 7 mg, 14 mg, or placebo. The primary end point was change from baseline to week 26 in HbA 1c . The confirmatory secondary end point was change from baseline to week 26 in body weight.
RESULTS


In the 703 patients randomized (mean age 55 years, 50.8% male, and mean baseline HbA 1c  8.0% [64 mmol/mol]), oral semaglutide reduced HbA 1c  (placebo-adjusted treatment differences at week 26: treatment policy estimand, -0.6% [3 mg], -0.9% [7 mg], and -1.1% [14 mg]; trial product estimand, -0.7% [3 mg], -1.2% [7 mg], and -1.4% [14 mg];  P  < 0.001 for all) and body weight (treatment policy, -0.1 kg [3 mg], -0.9 kg [7 mg], and -2.3 kg [14 mg,  P  < 0.001]; trial product, -0.2 kg [3 mg], -1.0 kg [7 mg,  P  = 0.01], and -2.6 kg [14 mg,  P  < 0.001]). Mild-to-moderate transient gastrointestinal events were the most common adverse events with oral semaglutide. Trial product discontinuations occurred in 2.3-7.4% with oral semaglutide and 2.2% with placebo.
CONCLUSIONS


In patients with type 2 diabetes, oral semaglutide monotherapy demonstrated superior and clinically relevant improvements in HbA 1c  (all doses) and body weight loss (14 mg dose) versus placebo, with a safety profile consistent with other GLP-1 receptor agonists.",2019,"In patients with T2D, oral semaglutide monotherapy demonstrated superior and clinically relevant improvements in HbA 1c  (all doses) and body weight loss (14 mg dose) vs placebo, with a safety profile consistent with other GLP-1 receptor agonists.
","['703 patients randomized (mean age 55 years; 50.8% male; mean baseline HbA 1c  8.0% [64 mmol/mol', 'Patients with Type 2 Diabetes', '93 sites in 9 countries', 'patients with type 2 diabetes (T2D) managed by diet and exercise alone', 'Adults with T2D insufficiently controlled with diet and exercise']","['Oral Semaglutide Monotherapy with Placebo', 'placebo']","['oral semaglutide reduced HbA 1c', 'body weight loss', 'body weight', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",703.0,0.32625,"In patients with T2D, oral semaglutide monotherapy demonstrated superior and clinically relevant improvements in HbA 1c  (all doses) and body weight loss (14 mg dose) vs placebo, with a safety profile consistent with other GLP-1 receptor agonists.
","[{'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA varoda@bwh.harvard.edu.""}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, TX.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Terauchi', 'Affiliation': 'Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Yuksel', 'Initials': 'Y', 'LastName': 'Altuntas', 'Affiliation': 'Division of Endocrinology Metabolism Diabetes, Department of Internal Medicine, Sisli Hamidiye Etfal Teaching and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Nebojsa M', 'Initials': 'NM', 'LastName': 'Lalic', 'Affiliation': 'Clinic for Endocrinology, Diabetes and Metabolic Diseases, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Enrique C', 'Initials': 'EC', 'LastName': 'Morales Villegas', 'Affiliation': 'Cardiometabolic Research Center, Aguascalientes, Mexico.'}, {'ForeName': 'Ole K', 'Initials': 'OK', 'LastName': 'Jeppesen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Christiansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Christin L', 'Initials': 'CL', 'LastName': 'Hertz', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haluzík', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0749']
703,31320446,"Once-Weekly Efpeglenatide Dose-Range Effects on Glycemic Control and Body Weight in Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide.","OBJECTIVE


To explore the efficacy, safety, and tolerability of once-weekly efpeglenatide, a long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA), in early type 2 diabetes (T2D) (drug naive or on metformin monotherapy).
RESEARCH DESIGN AND METHODS


EXCEED 203 was a 12-week, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study of efpeglenatide once weekly referenced to open-label liraglutide 1.8 mg (exploratory analysis). Participants, ∼90% on metformin monotherapy, were randomized to one of five efpeglenatide doses (0.3, 1, 2, 3, or 4 mg q.w.;  n  = 181), placebo ( n  = 37), or liraglutide (≤1.8 mg daily;  n  = 36). The primary efficacy end point was change in HbA 1c  from baseline to week 13.
RESULTS


From a baseline HbA 1c  of 7.7-8.0% (61.0-63.9 mmol/mol), all efpeglenatide doses ≥1 mg significantly reduced HbA 1c  versus placebo (placebo-adjusted least squares [LS] mean changes 0.6-1.2%,  P  < 0.05 for all) to a final HbA 1c  of 6.3-6.8% (45.4-50.6 mmol/mol); masked efpeglenatide 4 mg was noninferior to open-label liraglutide. Greater proportions treated with efpeglenatide ≥1 mg than placebo achieved HbA 1c  <7% (61-72% vs. 24%,  P  < 0.05 for all), and greater reductions in body weight were observed with efpeglenatide 3 and 4 mg versus placebo (placebo-adjusted LS mean differences -1.4 and -2.0 kg, respectively,  P <  0.05 for both). Rates of nausea and vomiting were consistent with other GLP-1 RAs and rapidly subsided after the initial 2 weeks. No neutralizing antibodies were detected with efpeglenatide.
CONCLUSIONS


Efpeglenatide once weekly led to significant reductions in HbA 1c  and weight, with a safety profile consistent with the GLP-1 RA class in patients with early T2D mostly on metformin monotherapy.",2019,"(placebo-adjusted LS mean differences -1.4 and -2.0 kg, respectively,  P <  0.05 for both).","['early type 2 diabetes (T2D) (drug naive or on metformin monotherapy', 'Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide']","['placebo (placebo-adjusted least squares [LS', 'liraglutide', 'efpeglenatide once weekly referenced to open-label liraglutide', 'placebo', 'glucagon-like peptide 1 receptor agonist (GLP-1 RA', 'metformin monotherapy']","['efficacy, safety, and tolerability', 'change in HbA 1c', 'neutralizing antibodies', 'Rates of nausea and vomiting', 'Glycemic Control and Body Weight', 'body weight']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.1652,"(placebo-adjusted LS mean differences -1.4 and -2.0 kg, respectively,  P <  0.05 for both).","[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, TX juliorosenstock@dallasdiabetes.com.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Sorli', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Trautmann', 'Affiliation': 'ProSciento, Chula Vista, CA.'}, {'ForeName': 'Cristóbal', 'Initials': 'C', 'LastName': 'Morales', 'Affiliation': 'Day Hospital & Diabetes Research Unit, Clinical Management Unit Endocrinology and Nutrition, Virgen Macarena University Hospital, Seville, Spain.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Wendisch', 'Affiliation': 'Group Practice in Internal Medicine and Diabetology, Hamburg, Germany.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dailey', 'Affiliation': 'Scripps Clinic, John R. Anderson V Medical Pavilion, La Jolla, CA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hompesch', 'Affiliation': 'ProSciento, Chula Vista, CA.'}, {'ForeName': 'In Young', 'Initials': 'IY', 'LastName': 'Choi', 'Affiliation': 'Hanmi Pharmaceutical Co., Ltd., Seoul, South Korea.'}, {'ForeName': 'Jahoon', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Hanmi Pharmaceutical Co., Ltd., Seoul, South Korea.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi Canada, Laval, Quebec, Canada.'}, {'ForeName': 'Kun-Ho', 'Initials': 'KH', 'LastName': 'Yoon', 'Affiliation': 'The Catholic University of Korea, Seoul, South Korea.'}]",Diabetes care,['10.2337/dc18-2648']
704,30850756,Comparative effectiveness of drugs used to constrict the patent ductus arteriosus: a secondary analysis of the PDA-TOLERATE trial (NCT01958320).,"OBJECTIVE


To evaluate the effectiveness of drugs used to constrict patent ductus arteriosus (PDA) in newborns < 28 weeks.
METHODS


We performed a secondary analysis of the multi-center PDA-TOLERATE trial (NCT01958320). Infants with moderate-to-large PDAs were randomized 1:1 at 8.1 ± 2.1 days to either Drug treatment (n = 104) or Conservative management (n = 98). Drug treatments were assigned by center rather than within center (acetaminophen: 5 centers, 27 infants; ibuprofen: 7 centers, 38 infants; indomethacin: 7 centers, 39 infants).
RESULTS


Indomethacin produced the greatest constriction (compared with spontaneous constriction during Conservative management): RR (95% CI) = 3.21 (2.05-5.01)), followed by ibuprofen = 2.03 (1.05-3.91), and acetaminophen = 1.33 (0.55-3.24). The initial rate of acetaminophen-induced constriction was 27%. Infants with persistent moderate-to-large PDA after acetaminophen were treated with indomethacin. The final rate of constriction after acetaminophen ± indomethacin was 60% (similar to the rate in infants receiving indomethacin-alone (62%)).
CONCLUSION


Indomethacin was more effective than acetaminophen in producing ductus constriction.",2019,"RESULTS


Indomethacin produced the greatest constriction (compared with spontaneous constriction during Conservative management): RR (95% CI) = 3.21 (2.05-5.01)), followed by ibuprofen = 2.03 (1.05-3.91), and acetaminophen = 1.33 (0.55-3.24).","['patent ductus arteriosus', 'Infants with moderate-to-large PDAs', 'newborns\u2009<\u200928 weeks', 'Infants with persistent moderate-to-large PDA after']","['constrict patent ductus arteriosus (PDA', 'ibuprofen', 'acetaminophen', 'Indomethacin', 'indomethacin', 'Drug treatment (n\u2009=\u2009104) or Conservative management']","['greatest constriction', 'final rate of constriction', 'initial rate of acetaminophen-induced constriction']","[{'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1444778', 'cui_str': 'Constricting'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",,0.0871162,"RESULTS


Indomethacin produced the greatest constriction (compared with spontaneous constriction during Conservative management): RR (95% CI) = 3.21 (2.05-5.01)), followed by ibuprofen = 2.03 (1.05-3.91), and acetaminophen = 1.33 (0.55-3.24).","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Liebowitz', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kaempf', 'Affiliation': 'Providence St. Vincent Medical Center, Portland, OR, USA.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Erdeve', 'Affiliation': ""Ankara University School of Medicine Children's Hospital, Ankara, Turkey.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bulbul', 'Affiliation': 'Sisli Hamidiye Etfal Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Stellan', 'Initials': 'S', 'LastName': 'Håkansson', 'Affiliation': 'Umea University Hospital, Umea, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Lindqvist', 'Affiliation': 'Umea University Hospital, Umea, Sweden.'}, {'ForeName': 'Aijaz', 'Initials': 'A', 'LastName': 'Farooqi', 'Affiliation': 'Umea University Hospital, Umea, Sweden.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Katheria', 'Affiliation': 'Sharp Mary Birch Hospital, San Diego, CA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Sauberan', 'Affiliation': 'Sharp Mary Birch Hospital, San Diego, CA, USA.'}, {'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Nelson', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wickremasinghe', 'Affiliation': 'Kaiser Permanente Santa Clara Medical Center, Santa Clara, CA, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Kaiser Permanente Santa Clara Medical Center, Santa Clara, CA, USA.'}, {'ForeName': 'Denise C', 'Initials': 'DC', 'LastName': 'Hassinger', 'Affiliation': 'Morristown Medical Center, Morristown, NJ, USA.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Aucott', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Hayashi', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Heuchan', 'Affiliation': 'University of Glasgow, Royal Hospital for Sick Children, Glasgow, Scotland, UK.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Carey', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Derrick', 'Affiliation': 'Northshore University Health System, Evanston, IL, USA.'}, {'ForeName': 'Ilene Sue', 'Initials': 'IS', 'LastName': 'Wolf', 'Affiliation': 'Northshore University Health System, Evanston, IL, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kimball', 'Affiliation': ""University of California San Diego and Rady Children's Hospital, San Diego, CA, USA.""}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Sankar', 'Affiliation': 'Good Samaritan Hospital, San Jose, CA, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Leone', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'South Miami Hospital/Baptist Health South Florida, Miami, FL, USA.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Serize', 'Affiliation': 'South Miami Hospital/Baptist Health South Florida, Miami, FL, USA.'}, {'ForeName': 'Ronald I', 'Initials': 'RI', 'LastName': 'Clyman', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, CA, USA. clymanr@peds.ucsf.edu.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0347-4']
705,31402223,Fascia Iliaca Blockade With the Addition of Liposomal Bupivacaine Versus Plain Bupivacaine for Perioperative Pain Management During Hip Arthroscopy: A Double-Blinded Prospective Randomized Control Trial.,"PURPOSE


To determine in a prospective, randomized fashion whether liposomal bupivacaine extends the effectiveness of decreased pain scores and reduces narcotic requirements following hip arthroscopy when used in addition to a fascia iliaca blockade with plain bupivacaine alone.
METHODS


Double-blinded prospective randomized controlled trial of participants undergoing hip arthroscopy. Randomized to receive a fascia iliaca blockade with 40 mL 0.25% plain bupivacaine (100 mg; control group) or 20 mL 0.5% plain bupivacaine (100 mg) plus 20 mL liposomal bupivacaine (266 mg; study group). The primary outcome was Defense and Veterans Pain Rating Scale (DVPRS) scores in the postanesthesia care unit and on postoperative days (POD) 1, 2, 3, and 14. Secondary outcomes included postoperative opioid consumption and subjective loss of anterior thigh sensation.
RESULTS


Seventy-four patients were enrolled, and 70 completed the study; 37 were randomized to the control group and 33 to the study group. There was no significant difference in postoperative DVPRS scores at any time point. There was no significant difference in total postoperative opioid use during any postoperative time points. While most patients reported anterior thigh numbness at discharge, significantly more patients in the study group reported anterior thigh numbness at POD2 (control, 19/37 numb vs study, 32/33 numb; P < .0001) and at POD3 (control, 8/37 numb vs study, 26/33 numb; P < .0001).
CONCLUSIONS


In this prospective evaluation comparing plain bupivacaine versus the liposomal formulation administered via a fascia iliaca blockade there were no significant differences in postoperative pain scores and narcotic pill usage. Given the highly significant findings of prolonged anterior thigh numbness out to POD3 in patients who received liposomal bupivacaine, this formulation did exhibit prolonged effects; however, it did not provide improved pain control when used in this surgical population, likely due to the innervation of the hip capsule from differential nerve plexi. Given the 6-fold increased cost of using the liposomal formulation, we are unable to recommend its use via a fascia iliaca blockade for hip arthroscopy.
LEVEL OF EVIDENCE


Level I, therapeutic study.",2019,There was no significant difference in postoperative DVPRS scores at any time point.,"['Seventy-four patients were enrolled, and 70 completed the study; 37 were randomized to the control group and 33 to the study group', 'participants undergoing hip arthroscopy']","['liposomal bupivacaine', '20\xa0mL 0.5% plain bupivacaine', 'fascia iliaca blockade with 40\xa0mL 0.25% plain bupivacaine', 'plain bupivacaine', 'Liposomal Bupivacaine Versus Plain Bupivacaine']","['anterior thigh numbness', 'anterior thigh numbness at POD2', 'total postoperative opioid use', 'Perioperative Pain Management', 'Defense and Veterans Pain Rating Scale (DVPRS) scores in the postanesthesia care unit and on postoperative days (POD) 1, 2, 3, and 14', 'narcotic requirements', 'postoperative opioid consumption and subjective loss of anterior thigh sensation', 'pain control', 'postoperative DVPRS scores', 'postoperative pain scores and narcotic pill usage', 'pain scores']","[{'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",74.0,0.275988,There was no significant difference in postoperative DVPRS scores at any time point.,"[{'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Purcell', 'Affiliation': 'Department of Orthopaedics, Walter Reed National Military Medical Center, Bethesda, Maryland, U.S.A.. Electronic address: richard.l.purcell10.mil@mail.mil.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Brooks', 'Affiliation': 'Department of Research Programs, Walter Reed National Military Medical Center, Bethesda, Maryland, U.S.A.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Steelman', 'Affiliation': 'Department of Orthopaedics, Walter Reed National Military Medical Center, Bethesda, Maryland, U.S.A.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Christensen', 'Affiliation': 'Department of Orthopaedics, Walter Reed National Military Medical Center, Bethesda, Maryland, U.S.A.'}, {'ForeName': 'Jonathan F', 'Initials': 'JF', 'LastName': 'Dickens', 'Affiliation': 'Department of Orthopaedics, Walter Reed National Military Medical Center, Bethesda, Maryland, U.S.A.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Kent', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, U.S.A.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'McCabe', 'Affiliation': 'APEX Orthopedic and Sports Medicine, Overland Park, Kansas, U.S.A.'}, {'ForeName': 'Terrence D', 'Initials': 'TD', 'LastName': 'Anderson', 'Affiliation': 'Department of Orthopedic Surgery, University of Texas Health Science Center at Houston (T.D.A.), Houston, Texas, U.S.A.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.03.056']
706,31408838,APOE gene-dependent BOLD responses to a breath-hold across the adult lifespan.,"Age and apolipoprotein E (APOE) e4 genotype are two of the strongest known risk factors for sporadic Alzheimer's disease (AD). Neuroimaging has shown hemodynamic response changes with age, in asymptomatic carriers of the APOE e4 allele, and in AD. In this study, we aimed to characterize and differentiate age- and APOE gene-specific hemodynamic changes to breath-hold and visual stimulation. A further aim was to study whether these responses were modulated by 3-day intake of nitrate, a nitric oxide (NO) source. The study was designed as a randomized, double-blinded, placebo-controlled crossover study, and the study cohort comprised 41 APOE e4 carriers (e3/e4 or e4/e4 genotype) and 40 non-carriers (e3/e3 genotype) aged 30-70 years at enrollment. The participants underwent two scanning sessions, each preceded by ingestion of sodium nitrate or sodium chloride (control). During functional magnetic resonance imaging (fMRI) sessions, participants performed two concurrent tasks; a breath-hold task to probe cerebrovascular reactivity and a visual stimulation task to evoke functional hyperemia, respectively. We found that the blood oxygenation level dependent (BOLD) hemodynamic response to breath-hold was altered in APOE e4 carriers relative to non-carriers. Mid-aged (50-60 years of age) e4 carriers exhibited a significantly increased peak time relative to mid-aged e3 carriers, and peak time for younger (30-40 years of age) e4 carriers was significantly shorter than that of mid-aged e4 carriers. The response width was significantly increased for e4 carriers. The response peak magnitude significantly decreased with age. For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type. We found no effect of nitrate ingestion on BOLD responses evoked by the breath-hold and visual stimulation tasks. The APOE gene-dependent response to breath-hold may reflect NO-independent differences in vascular function.",2019,"For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type.",['41 APOE e4 carriers (e3/e4 or e4/e4 genotype) and 40 non-carriers (e3/e3 genotype) aged 30-70\u202fyears at enrollment'],"['sodium nitrate or sodium chloride (control', 'placebo', 'functional magnetic resonance imaging (fMRI) sessions', 'nitrate ingestion']","['response peak magnitude', 'blood oxygenation level dependent (BOLD) hemodynamic response', 'peak time relative', 'response width', 'Age and apolipoprotein E (APOE']","[{'cui': 'C0003595', 'cui_str': 'Apo-E'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0074748', 'cui_str': 'sodium nitrate'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0523511', 'cui_str': 'Apolipoproteins E measurement (procedure)'}, {'cui': 'C0003595', 'cui_str': 'Apo-E'}]",,0.218788,"For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type.","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rasmussen', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: pmr@cfin.au.dk.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Aamand', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Weitzberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Christiansen', 'Affiliation': 'Department for Congenital Disorders, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Torben E', 'Initials': 'TE', 'LastName': 'Lund', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101955']
707,31296648,Long-term Weight Loss Maintenance in the Continuation of a Randomized Diabetes Prevention Translational Study: The Healthy Living Partnerships to Prevent Diabetes (HELP PD) Continuation Trial.,"OBJECTIVE


HELP PD was a clinical trial of 301 adults with prediabetes. Participants were randomized to enhanced usual care (EUC) or to a lifestyle weight loss (LWL) intervention led by community health workers that consisted of a 6-month intensive phase (phase 1) and 18 months of maintenance (phase 2). At 24 months, participants were asked to enroll in phase 3 to assess whether continued group maintenance (GM) sessions would maintain improvements realized in phases 1 and 2 compared with self-directed maintenance (SM) or EUC.
RESEARCH DESIGN AND METHODS


In phase 3, LWL participants were randomly assigned to GM or SM. EUC participants remained in the EUC arm and, along with participants in SM, received monthly newsletters. All participants received semiannual dietitian sessions. Anthropometrics and biomarkers were assessed every 6 months. Mixed-effects models were used to assess changes in outcomes over time.
RESULTS


Eighty-two of the 151 intervention participants (54%) agreed to participate in phase 3; 41 were randomized to GM and 41 to SM. Of the 150 EUC participants, 107 (71%) continued. Ninety percent of clinic visits were completed. Over 48 months of additional follow-up, outcomes remained relatively stable in the EUC participants; the GM group was able to maintain body weight, BMI, and waist circumference; and these measures all increased significantly ( P  < 0.001) in the SM group.
CONCLUSIONS


Participants in the GM arm maintained weight loss achieved in phases 1 and 2, while those in the SM arm regained weight. Because group session attendance by the participants in the GM arm was low, it is unclear what intervention components led to successful weight maintenance.",2019,"Over 48 months of additional follow-up, outcomes remained relatively stable in the EUC participants; the GM group was able to maintain body weight, BMI, and waist circumference; and these measures all increased significantly ( P  < 0.001) in the SM group.
","['301 adults with prediabetes', 'Eighty-two of the 151 intervention participants (54%) agreed to participate in phase 3; 41']","['enhanced usual care (EUC) or to a lifestyle weight loss (LWL) intervention led by community health workers that consisted of a 6-month intensive phase', 'GM or SM', 'continued group maintenance (GM) sessions would maintain improvements realized in phases 1 and 2 compared with self-directed maintenance (SM) or EUC', 'semiannual dietitian sessions', 'Long-term Weight Loss Maintenance']","['maintain body weight, BMI, and waist circumference', 'maintained weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",301.0,0.0801487,"Over 48 months of additional follow-up, outcomes remained relatively stable in the EUC participants; the GM group was able to maintain body weight, BMI, and waist circumference; and these measures all increased significantly ( P  < 0.001) in the SM group.
","[{'ForeName': 'Mara Z', 'Initials': 'MZ', 'LastName': 'Vitolins', 'Affiliation': 'Department of Epidemiology and Prevention, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC mvitolin@wakehealth.edu.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Blackwell', 'Affiliation': 'Department of Epidemiology and Prevention, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Katula', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Isom', 'Affiliation': 'Department of Biostatistics and Data Sciences, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'L Douglas', 'Initials': 'LD', 'LastName': 'Case', 'Affiliation': 'Department of Biostatistics and Data Sciences, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}]",Diabetes care,['10.2337/dc19-0295']
708,31300280,Randomized controlled trial demonstrating the benefits of delta inulin adjuvanted immunotherapy in patients with bee venom allergy.,"BACKGROUND


Allergic reactions to Hymenoptera insect stings remain a major global clinical problem. Although effective, parenteral desensitization regimens require use of costly venom extracts and require frequent visits over extended periods of time.
OBJECTIVE


Adjuvants are commonly used to enhance the efficacy of infectious disease vaccines, and this study asked whether Advax (Vaxine Pty Ltd, Adelaide, Australia), a novel noninflammatory polysaccharide adjuvant, might provide similar benefits for allergy desensitization.
METHODS


A randomized, controlled phase 1/2 trial was undertaken in 27 adults with a history of rapid-onset systemic allergic reactions to honeybee stings and positive specific IgE levels to evaluate the safety and efficacy of honeybee venom immunotherapy (HBVIT) combined with Advax adjuvant. Venom immunotherapy (VIT) was administered monthly for 30 months after achievement of maintenance doses.
RESULTS


Advax-adjuvanted HBVIT was well tolerated. Around week 14 of VIT, specific IgG 4  responses peaked in both groups but increased earlier, peaked higher, and were better maintained through the end of the study in the Advax-adjuvanted arm. Several different patterns of serologic response to VIT were seen; some subjects had a dominant IgG 4  response, some had a combined IgG 4  and IgG 1  response, and some had an exclusively IgG 1  response. In some subjects specific IgE levels increased during the induction phase and then decreased, whereas in others specific IgE levels progressively decreased from the start of VIT.
CONCLUSION


Advax adjuvant favorably enhanced the immunogenicity of HBVIT, with an early and prolonged switch to specific IgG 4  production. The ability of Advax adjuvant to enhance VIT efficacy warrants further study.",2019,"Around week 14 of VIT, specific IgG 4  responses peaked in both groups but increased earlier, peaked higher, and were better maintained through the end of the study in the Advax-adjuvanted arm.","['27 adults with a history of rapid-onset systemic allergic reactions to honeybee stings and positive specific IgE levels to evaluate the', 'patients with bee venom allergy']","['Advax adjuvant', 'Venom immunotherapy (VIT', 'honeybee venom immunotherapy (HBVIT) combined with Advax adjuvant', 'delta inulin adjuvanted immunotherapy']","['tolerated', 'immunogenicity of HBVIT', 'specific IgE levels', 'safety and efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1736167', 'cui_str': 'Systemic allergic reaction'}, {'cui': 'C0323351', 'cui_str': 'Apis mellifera (organism)'}, {'cui': 'C0038340', 'cui_str': 'Stings'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004920', 'cui_str': 'Apis Venoms'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}]","[{'cui': 'C3530029', 'cui_str': 'advax'}, {'cui': 'C0419067', 'cui_str': 'Venom immunotherapy'}, {'cui': 'C0323351', 'cui_str': 'Apis mellifera (organism)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",27.0,0.098978,"Around week 14 of VIT, specific IgG 4  responses peaked in both groups but increased earlier, peaked higher, and were better maintained through the end of the study in the Advax-adjuvanted arm.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Heddle', 'Affiliation': 'University of Adelaide, North Terrace, Adelaide, Australia; Royal Adelaide Hospital, North Terrace, Adelaide, Australia; Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Allergy and Clinical Immunology Department, Flinders Medical Centre, Bedford Park, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Pravin', 'Initials': 'P', 'LastName': 'Hissaria', 'Affiliation': 'Royal Adelaide Hospital, North Terrace, Adelaide, Australia.'}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Petrovsky', 'Affiliation': 'Flinders University, Bedford Park, Australia; Vaxine, Bedford Park, Australia. Electronic address: nikolai.petrovsky@flinders.edu.au.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.03.035']
709,31283409,"Neoadjuvant Three-Dimensional Conformal Radiotherapy for Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Randomized, Open-Label, Multicenter Controlled Study.","PURPOSE


To compare the survival outcomes of neoadjuvant three-dimensional conformal radiotherapy (RT) followed by hepatectomy with hepatectomy alone in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT).
PATIENTS AND METHODS


A randomized, multicenter controlled study was conducted from January 2016 to December 2017 in patients with resectable HCC and PVTT. Patients were randomly assigned to receive neoadjuvant RT followed by hepatectomy (n = 82) or hepatectomy alone (n = 82). The modified Response Evaluation Criteria in Solid Tumors (mRECIST) guidelines were used to evaluate the therapeutic effects of RT. The primary end point was overall survival. The expression of interleukin-6 (IL-6) in patients' serum before RT and in surgical specimens was correlated with response to RT.
RESULTS


In the neoadjuvant RT group, 17 patients (20.7%) had partial remission. The overall survival rates for the neoadjuvant RT group at 6, 12, 18, and 24 months were 89.0%, 75.2%, 43.9%, and 27.4%, respectively, compared with 81.7%, 43.1%, 16.7%, and 9.4% in the surgery-alone group ( P  < .001). The corresponding disease-free survival rates were 56.9%, 33.0%, 20.3%, and 13.3% versus 42.1%, 14.9%, 5.0%, and 3.3% ( P  < .001). On multivariable Cox regression analyses, neoadjuvant RT significantly reduced HCC-related mortality and HCC recurrence rates compared with surgery alone (hazard ratios, 0.35 [95% CI, 0.23 to 0.54;  P  < .001] and 0.45 [95% CI, 0.31 to 0.64;  P  < .001]). Increased expressions of IL-6 in pre-RT serum and tumor tissues were significantly associated with resistance to RT.
CONCLUSION


For patients with resectable HCC and PVTT, neoadjuvant RT provided significantly better postoperative survival outcomes than surgery alone. IL-6 may predict response to RT in these patients.",2019,"The expression of interleukin-6 (IL-6) in patients' serum before RT and in surgical specimens was correlated with response to RT.
","['Resectable Hepatocellular Carcinoma', 'January 2016 to December 2017 in patients with resectable HCC and PVTT', 'patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT', 'With Portal Vein Tumor Thrombus']","['neoadjuvant RT followed by hepatectomy', 'PVTT', 'hepatectomy alone', 'hepatectomy with hepatectomy alone', 'IL-6', 'neoadjuvant three-dimensional conformal radiotherapy (RT', 'Neoadjuvant Three-Dimensional Conformal Radiotherapy']","['partial remission', 'expression of interleukin-6 (IL-6', 'corresponding disease-free survival rates', 'survival outcomes', 'Increased expressions of IL-6 in pre-RT serum and tumor tissues', 'overall survival rates', 'HCC-related mortality and HCC recurrence rates', 'postoperative survival outcomes', 'overall survival']","[{'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C3163918', 'cui_str': 'Tumor thrombus'}]","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0600521', 'cui_str': 'Three-Dimensional Conformal Radiotherapy'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",,0.0761295,"The expression of interleukin-6 (IL-6) in patients' serum before RT and in surgical specimens was correlated with response to RT.
","[{'ForeName': 'Xubiao', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yabo', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Xiuping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': ""2Department of Health Statistics, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xing', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Weixing', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': ""3Fujian Provincial Cancer Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""3Fujian Provincial Cancer Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Huichuan', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""4Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ""4Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Congde', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yaxin', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Wenming', 'Initials': 'W', 'LastName': 'Cong', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Wan Yee', 'Initials': 'WY', 'LastName': 'Lau', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}, {'ForeName': 'Shuqun', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': ""1Eastern Hepatobiliary Surgery Hospital, Navy Military Medical University, Shanghai, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02184']
710,31440032,Pharmacokinetics and tolerability of IDP-73152 mesylate after a single oral administration under fasted and fed conditions in healthy volunteers.,"Background and objective


IDP-73152 mesylate is a peptide deformylase inhibitor under investigation for the treatment of complicated skin and respiratory tract infections. The objective of this study was to investigate the pharmacokinetic (PK) profile and tolerability of IDP-73152 and the effect of food after a single oral administration.
Methods


A dose block-randomized, double-blind, placebo-controlled, dose-escalation study was conducted. A total of 56 healthy volunteers received IDP-73152 mesylate in a single oral dose of 40, 80, 160, 320, 640, or 1280 mg in the fasted and fed (640 mg only) states. Blood and urine samples for PK analysis were collected up to 48 h post dose.
Results


The area under the plasma concentration-time curve (AUC 0-t ) of IDP-73152 increased in a dose-proportional manner in the range of 40-320 mg. The mean terminal half-life decreased from 10.7 to 6.2 hrs as the dose increased. The fraction excreted unchanged in the urine ranged from 0.05 to 0.12. In the 640-mg dose group, food delayed the median time to peak concentration ( t   max ) from 0.9 to 3.5 hrs. Furthermore, the maximum plasma concentration (C max ) were decreased by 36.2%; however, AUC 0-t  was not generally affected. No serious adverse event or clinically significant findings were observed.
Conclusions


The systemic exposure of IDP-73152 proportionally increased as the dose increased up to 320 mg. The rate of absorption and extent of exposure were reduced by food intake. IDP-73152 was well tolerated without clinically significant adverse effects after a single oral administration.",2019,The area under the plasma concentration-time curve (AUC 0-t ) of IDP-73152 increased in a dose-proportional manner in the range of 40-320 mg.,"['56 healthy volunteers', 'healthy volunteers']","['placebo', 'IDP-73152 mesylate', 'IDP-73152']","['Pharmacokinetics and tolerability', 'maximum plasma concentration (C max ', 'mean terminal half-life', 'median time to peak concentration', 'systemic exposure of IDP-73152', 'fraction excreted', 'pharmacokinetic (PK) profile and tolerability', 'rate of absorption and extent of exposure', 'plasma concentration-time curve (AUC 0-t ) of IDP-73152']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021532', 'cui_str': 'Riboxin'}, {'cui': 'C3645051', 'cui_str': 'mesylate'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0021532', 'cui_str': 'Riboxin'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",56.0,0.131628,The area under the plasma concentration-time curve (AUC 0-t ) of IDP-73152 increased in a dose-proportional manner in the range of 40-320 mg.,"[{'ForeName': 'Dongseong', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Department of Pharmacology, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Sang-In', 'Initials': 'SI', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyung Hee University Hospital, Seoul, Korea.'}, {'ForeName': 'Hong-Sub', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Research Laboratories ILDONG Pharmaceutical Co. Ltd, Hwaseong, Korea.'}, {'ForeName': 'Kyung-Mi', 'Initials': 'KM', 'LastName': 'An', 'Affiliation': 'Research Laboratories ILDONG Pharmaceutical Co. Ltd, Hwaseong, Korea.'}, {'ForeName': 'Juyoung', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'Research Laboratories ILDONG Pharmaceutical Co. Ltd, Hwaseong, Korea.'}, {'ForeName': 'MyongJae', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Research Laboratories ILDONG Pharmaceutical Co. Ltd, Hwaseong, Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}]","Drug design, development and therapy",['10.2147/DDDT.S209238']
711,31505367,Blame-rebalance fMRI neurofeedback in major depressive disorder: A randomised proof-of-concept trial.,"Previously, using fMRI, we demonstrated lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions while patients with major depressive disorder (MDD) experience guilt. This neural signature was detected despite symptomatic remission which suggested a putative role in vulnerability. This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature. To this end, we developed a fMRI neurofeedback software (FRIEND), which measures ATL-SCC coupling and displays its levels in real time. Twenty-eight patients with remitted MDD were randomised to two groups, each receiving one session of fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories. They were instructed to feel the emotion whilst trying to increase the level of a thermometer-like display on a screen. Active intervention group: The thermometer levels increased with increasing levels of ATL-SCC correlations in the guilt condition. Control intervention group: The thermometer levels decreased when correlation levels deviated from the previous baseline level in the guilt condition, thus reinforcing stable correlations. Both groups also received feedback during the indignation condition reinforcing stable correlations. We confirmed our predictions that patients in the active intervention group were indeed able to increase levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem after training compared to before training and that this differed significantly from the control intervention group. These data provide proof-of-concept for a novel treatment target for MDD patients and are in keeping with the hypothesis that ATL-SCC connectivity plays a key role in self-worth. https://clinicaltrials.gov/ct2/show/results/NCT01920490.",2019,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"['patients with major depressive disorder (MDD) experience guilt', 'major depressive disorder', 'patients with MDD', 'Twenty-eight patients with remitted MDD']","['fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories', 'Control intervention']","['levels of ATL-SCC correlations', 'lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions', 'levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441997', 'cui_str': 'Right anterior (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0018427', 'cui_str': 'Cingulate Body'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",28.0,0.0826356,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Julie H', 'Initials': 'JH', 'LastName': 'Weingartner', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Basilio', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bado', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas (ICB), Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Mattos', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'João R', 'Initials': 'JR', 'LastName': 'Sato', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Center for Mathematics, Computation, and Cognition, Universidade Federal do ABC, Santo André, Brazil.""}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'de Oliveira-Souza', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Gaffrée e Guinle University Hospital, Federal University of the State of Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Leo F', 'Initials': 'LF', 'LastName': 'Fontenelle', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moll', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Scients Institute, Palo Alto, USA. Electronic address: jorge.moll@idor.org.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101992']
712,31296647,Associations of Perfluoroalkyl and Polyfluoroalkyl Substances With Incident Diabetes and Microvascular Disease.,"OBJECTIVE


Perfluoroalkyl and polyfluoroalkyl substances (PFASs) are suspected endocrine disruptors widely detected across populations. We examine the extent to which PFASs are associated with diabetes incidence and microvascular disease. Secondarily, we tested whether a lifestyle intervention modifies associations and decreases concentrations.
RESEARCH DESIGN AND METHODS


We analyzed data from a prospective cohort of 957 participants from the Diabetes Prevention Program (DPP) trial and Diabetes Prevention Program Outcomes Study (DPPOS). At baseline, participants were randomized to an intensive lifestyle intervention of diet, physical activity, and behavior modification or a placebo medication. We quantified plasma concentrations of six PFASs at baseline and 2 years after randomization. Participants were monitored for ∼15 years, repeatedly tested for diabetes, and evaluated for microvascular disease at the end of the follow-up.
RESULTS


A doubling in baseline branched perfluorooctanoic acid concentration was associated with a 14% increase in diabetes risk for the placebo (hazard ratio [HR] 1.14, 95% CI 1.04, 1.25) but not in the lifestyle intervention group (HR 1.01, 95% CI 0.92, 1.11,  P   interaction  = 0.11). Mean change in plasma baseline branched perfluorooctanoic acid concentration was greater for the placebo (0.96 ng/mL; 95% CI 0.71, 1.22) compared with the lifestyle intervention group (0.31 ng/mL; 95% CI 0.14, 0.48) 2 years after randomization. Each doubling in  N -ethyl-perfluorooctane sulfonamido acetic acid was associated with 17% greater odds of prevalent microvascular disease (OR 1.17, 95% CI 1.05, 1.31), and a similar association was observed for perfluorodimethylhexane sulfonic acid (OR 1.18, 95% CI 1.04, 1.35), regardless of treatment.
CONCLUSIONS


Some plasma PFASs were associated with diabetes and microvascular disease. Our results suggest that exercise and diet may attenuate the diabetogenic association of PFASs.",2019,"Mean change in plasma baseline branched perfluorooctanoic acid concentration was greater for the placebo (0.96 ng/mL; 95% CI 0.71, 1.22) compared with the lifestyle intervention group (0.31 ng/mL; 95% CI 0.14, 0.48) 2 years after randomization.","['Participants were monitored for ∼15 years, repeatedly tested for diabetes, and evaluated for microvascular disease at the end of the follow-up', 'We analyzed data from a prospective cohort of 957 participants from the Diabetes Prevention Program (DPP) trial and Diabetes Prevention Program Outcomes Study (DPPOS']","['placebo', 'intensive lifestyle intervention of diet, physical activity, and behavior modification or a placebo medication']","['diabetes risk', 'prevalent microvascular disease', 'Mean change in plasma baseline branched perfluorooctanoic acid concentration', 'perfluorodimethylhexane sulfonic acid']","[{'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4554227', 'cui_str': 'Repeatedly - dosing instruction fragment'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0070403', 'cui_str': 'perfluorooctanoic acid'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038762', 'cui_str': 'Sulfonic Acids'}]",957.0,0.222315,"Mean change in plasma baseline branched perfluorooctanoic acid concentration was greater for the placebo (0.96 ng/mL; 95% CI 0.71, 1.22) compared with the lifestyle intervention group (0.31 ng/mL; 95% CI 0.14, 0.48) 2 years after randomization.","[{'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Cardenas', 'Affiliation': 'Division of Environmental Health Sciences, School of Public Health, University of California, Berkeley, Berkeley, CA andres.cardenas@berkeley.edu.'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Hivert', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Gold', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Hauser', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Ken P', 'Initials': 'KP', 'LastName': 'Kleinman', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Massachusetts-Amherst School of Public Health and Health Sciences, Amherst, MA.'}, {'ForeName': 'Pi-I D', 'Initials': 'PD', 'LastName': 'Lin', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}, {'ForeName': 'Abby F', 'Initials': 'AF', 'LastName': 'Fleisch', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Maine Medical Center, Portland, ME.'}, {'ForeName': 'Antonia M', 'Initials': 'AM', 'LastName': 'Calafat', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Webster', 'Affiliation': 'Department of Environmental Health, Boston University School of Public Health, Boston, MA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Oken', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}]",Diabetes care,['10.2337/dc18-2254']
713,32248637,Investigation of optimal dose of early intervention to prevent posttraumatic stress disorder: A multiarm randomized trial of one and three sessions of modified prolonged exposure.,"BACKGROUND


Posttraumatic stress disorder (PTSD) is linked to a specific event, providing the opportunity to intervene in the immediate aftermath of trauma to prevent the development of this disorder. A previous trial demonstrated that trauma survivors who received three sessions of modified prolonged exposure therapy demonstrated decreased PTSD and depression prospectively compared to assessment only. The present study investigated the optimal dosing of this early intervention to test one versus three sessions of exposure therapy in the immediate aftermath of trauma.
METHODS


Participants (n = 95) recruited from a Level 1 Trauma Center were randomly assigned in a 1.5:1.5:1 ratio in a parallel-group design to the three conditions: one-session exposure therapy, three-session exposure therapy, and assessment only. Follow-up assessments were conducted by study assessors blind to study condition.
RESULTS


Mixed-effects model results found no significant differences in PTSD or depression symptoms between the control condition and those who received one or three exposure therapy sessions across 1-12-month follow-up assessment. Results indicate that the intervention did not interfere with natural recovery. Receiver operating characteristic curve analyses on the screening measure used for study inclusion (Predicting PTSD Questionnaire; PPQ) in the larger sample from which the treatment sample was drawn (n = 481) found that the PPQ was a poor predictor of likely PTSD at all follow-up time points (Area under the curve's = 0.55-0.62).
CONCLUSIONS


This likely impacted study results as many participants demonstrated natural recovery. Recommendations for future early intervention research are reviewed, including strategies to identify more accurately those at risk for PTSD and oversampling more severe trauma types.",2020,"RESULTS


Mixed-effects model results found no significant differences in PTSD or depression symptoms between the control condition and those who received one or three exposure therapy sessions across 1-12-month follow-up assessment.","['trauma survivors', 'Participants (n\u2009=\u200995) recruited from a Level 1 Trauma Center', 'posttraumatic stress disorder', 'Posttraumatic stress disorder (PTSD']","['early intervention', 'session exposure therapy, three-session exposure therapy, and assessment only']","['PTSD or depression symptoms', 'PTSD and depression']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.012171,"RESULTS


Mixed-effects model results found no significant differences in PTSD or depression symptoms between the control condition and those who received one or three exposure therapy sessions across 1-12-month follow-up assessment.","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Maples-Keller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Loren M', 'Initials': 'LM', 'LastName': 'Post', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Price', 'Affiliation': 'Department of Psychological Science, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Goodnight', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Burton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Carly W', 'Initials': 'CW', 'LastName': 'Yasinski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Michopoulos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Stevens', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hinrichs', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Alex O', 'Initials': 'AO', 'LastName': 'Rothbaum', 'Affiliation': 'Department of Psychological Sciences, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hudak', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Houry', 'Affiliation': 'Division of Injury Prevention, National Center for Injury Control and Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Jovanovic', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Ressler', 'Affiliation': 'Department of Psychiatry, Mclean Hospital, Harvard Medical School, Belmont, Massachusetts.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Emory University, Atlanta, Georgia.'}]",Depression and anxiety,['10.1002/da.23015']
714,31670070,Evidence for decreased Neurologic Pain Signature activation following thoracic spinal manipulation in healthy volunteers and participants with neck pain.,"BACKGROUND CONTEXT


Spinal manipulation (SM) is a common treatment for neck and back pain, theorized to mechanically affect the spine leading to therapeutic mechanical changes. The link between specific mechanical effects and clinical improvement is not well supported. SM's therapeutic action may instead be partially mediated within the central nervous system.
PURPOSE


To introduce brain-based models of pain for spinal pain and manual therapy research, characterize the distributed central mechanisms of SM, and advance the preliminary validation of brain-based models as potential clinical biomarkers of pain.
STUDY DESIGN


Secondary analysis of two functional magnetic resonance imaging studies investigating the effect of thoracic SM on pain-related brain activity: A non-controlled, non-blinded study in healthy volunteers (Study 1, n = 10, 5 females, and mean age = 31.2 ± 10.0 years) and a randomized controlled study in participants with acute to subacute neck pain (Study 2, n = 24, 16 females, mean age = 38.0 ± 15.1 years).
METHODS


Functional magnetic resonance imaging was performed during noxious mechanical stimulation of the right index finger cuticle pre- and post-intervention. The effect of SM on pain-related activity was studied within brain regions defined by the Neurologic Pain Signature (NPS) that are predictive of physical pain.
RESULTS


In Study 1, evoked mechanical pain (p < 0.001) and NPS activation (p = 0.010) decreased following SM, and the changes in evoked pain and NPS activation were correlated (r RM 2  = 0.418, p = 0.016). Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019). In Study 2, neck pain (p = 0.046) and NPS (p = 0.033) activation decreased following verum but not sham SM. Associations between evoked pain, neck pain, and NPS activation, were not significant and less clear, possibly due to inadequate power, methodological limitations, or other confounding factors.
CONCLUSIONS


The findings provide preliminary evidence that SM may alter the processing of pain-related brain activity within specific pain-related brain regions and support the use of brain-based models as clinical biomarkers of pain.",2019,"Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019).","['healthy volunteers (Study 1, n\u202f=\u202f10, 5 females, and mean age\u202f=\u202f31.2\u202f±\u202f10.0 years', 'participants with acute to subacute neck pain (Study 2, n\u202f=\u202f24, 16 females, mean age\u202f=\u202f38.0\u202f±\u202f15.1 years', 'healthy volunteers and participants with neck pain']","['SM', 'thoracic SM', 'thoracic spinal manipulation']","['dACC activity', 'evoked mechanical pain', 'NPS activation', 'pain-related activity', 'Neurologic Pain Signature activation', 'evoked pain and NPS activation', 'NPS', 'SM, and evoked pain', 'neck pain', 'evoked pain, neck pain, and NPS activation', 'pain-related brain activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}]",,0.0871702,"Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019).","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Weber Ii', 'Affiliation': 'Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States. Electronic address: kenweber@stanford.edu.'}, {'ForeName': 'Tor D', 'Initials': 'TD', 'LastName': 'Wager', 'Affiliation': 'Psychology and Neuroscience, Center for Neuroscience, Institute of Cognitive Science, University of Colorado Boulder, Boulder, CO, United States.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Mackey', 'Affiliation': 'Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Elliott', 'Affiliation': 'Northern Sydney Local Health District, The Kolling Research Institute and The Faculty of Health Sciences, The University of Sydney, St. Leonards, NSW, Australia.'}, {'ForeName': 'Wen-Ching', 'Initials': 'WC', 'LastName': 'Liu', 'Affiliation': 'Center for Collaborative Brain Research, Department of Radiology, OSF HealthCare Saint Francis Medical Center, Peoria, IL, United States.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Sparks', 'Affiliation': 'Center of Expertise, Rehabilitation and Occupational Health, OSF HealthCare, Peoria, IL, United States; School of Physical Therapy, South College, Knoxville, TN, United States.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102042']
715,32249193,Randomized Comparison of Prostatic Artery Embolization versus Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia.,"PURPOSE


To compare clinical and functional outcomes of prostatic artery embolization (PAE) with those of transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
MATERIALS AND METHODS


Noninferiority randomized trial was conducted involving men over 60 years of age with LUTS secondary to BPH. From November 2014 to January 2017, 45 patients were randomized to PAE (n = 23) or to TURP (n = 22). PAE was performed with 300- to 500-μm microspheres with the patient under local anesthesia, whereas bipolar TURP was performed with the patients under spinal or general anesthesia. Primary outcomes were changes in peak urinary flow (Q max ) and international prostate symptoms score (IPSS) from baseline to 12 months. Quality of life (QoL), and prostate volume (PV) changes from baseline to 12 month were secondary outcomes. Adverse events were compared using the Clavien classification.
RESULTS


Mean Q max  increased from 6.1 mL/s in the PAE group and from 9.6 mL/s in the TURP patients (P = .862 for noninferiority), and mean IPSS reduction was 21.0 points for PAE and 18.2 points for TURP subjects (P = .080) at 12 months. A greater QoL improvement was reported in the PAE group (3.78 points for PAE and 3.09 points for TURP; P = .002). Mean PV reduction was 20.5 cm³ (34.2%) for PAE subjects and 44.7 cm³ (71.2%) for TURP subjects (P < .001). There were fewer adverse events reported in the PAE group than in the TURP group (n = 15 vs n = 47; P < .001).
CONCLUSIONS


Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE. Long-term follow-up is needed to compare the durability of the symptomatic improvement from each procedure.",2020,"CONCLUSIONS


Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE.","['Benign Prostatic Hyperplasia', 'lower urinary symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH', 'men over 60 years of age with LUTS secondary to BPH', 'From November 2014 to January 2017, 45 patients']","['prostatic artery embolization (PAE', 'TURP', 'Prostatic Artery Embolization versus Transurethral Resection', 'transurethral resection of the prostate (TURP', 'PAE']","['changes in peak urinary flow (Q max ) and international prostate symptoms score (IPSS', 'QoL improvement', 'mean IPSS reduction', 'adverse events', 'Quality of life (QoL), and prostate volume (PV) changes', 'Adverse events', 'Mean PV reduction', 'Mean Q max']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",45.0,0.0429549,"CONCLUSIONS


Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE.","[{'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Insausti', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain. Electronic address: insausti00@hotmail.com.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Sáez de Ocáriz', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Galbete', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra-Universidad Pública de Navarra, Red de Investigación en Servicios de Salud en Enfermedades Crónicas, Pamplona, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Capdevila', 'Affiliation': 'Department of Pharmacy, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Saioa', 'Initials': 'S', 'LastName': 'Solchaga', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Giral', 'Affiliation': 'Department of Urology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Bilhim', 'Affiliation': 'Department of Interventional Radiology, Hospital St. Louis, Lisbon, Portugal; Department of Radiology, NOVA Medical School, Lisbon, Portugal; Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Isaacson', 'Affiliation': 'Division of Vascular and Interventional Radiology, Department of Radiology, University of North Carolina Medical Center, Chapel Hill, North Carolina.'}, {'ForeName': 'Fermin', 'Initials': 'F', 'LastName': 'Urtasun', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Saturnino', 'Initials': 'S', 'LastName': 'Napal', 'Affiliation': 'Department of Urology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2019.12.810']
716,32248243,GAD-alum immunotherapy in type 1 diabetes expands bifunctional Th1/Th2 autoreactive CD4 T cells.,"AIMS/HYPOTHESIS


Antigen-specific therapy aims to modify inflammatory T cell responses in type 1 diabetes and restore immune tolerance. One strategy employs GAD65 conjugated to aluminium hydroxide (GAD-alum) to take advantage of the T helper (Th)2-biasing adjuvant properties of alum and thereby regulate pathological Th1 autoimmunity. We explored the cellular and molecular mechanism of GAD-alum action in the setting of a previously reported randomised placebo-controlled clinical trial conducted by Type 1 Diabetes TrialNet.
METHODS


In the clinical trial conducted by Type 1 Diabetes TrialNet, participants were immunised with 20 μg GAD-alum (twice or three times) or alum alone and peripheral blood mononuclear cell samples were banked at baseline and post treatment. In the present study, GAD-specific T cell responses were measured in these samples and GAD-specific T cell lines and clones were generated, which were then further characterised.
RESULTS


At day 91 post immunisation, we detected GAD-specific IL-13 +  CD4 T cell responses significantly more frequently in participants immunised with GAD-alum (71% and 94% treated twice or three times, respectively) compared with those immunised with alum alone (38%; p = 0.003 and p = 0.0002, respectively) accompanied by high secreted levels of IL-13, IL-4 and IL-5, confirming a GAD-specific, GAD-alum-induced Th2 response. Of note, GAD-specific, IL-13 +  CD4 T cells observed after immunisation co-secreted IFN-γ, displaying a bifunctional Th1/Th2 phenotype. Single-cell transcriptome analysis identified IL13 and IFNG expression in concert with the canonical Th2 and Th1 transcription factor genes GATA3 and TBX21, respectively. T cell receptor β-chain (TCRB) CDR3 regions of GAD-specific bifunctional T cells were identified in circulating naive and central memory CD4 T cell pools of non-immunised participants with new-onset type 1 diabetes and healthy individuals, suggesting the potential for bifunctional responses to be generated de novo by GAD-alum immunisation or via expansion from an existing public repertoire.
CONCLUSIONS/INTERPRETATION


GAD-alum immunisation activates and propagates GAD-specific CD4 T cells with a distinctive bifunctional phenotype, the functional analysis of which might be important in understanding therapeutic responses.",2020,"At day 91 post immunisation, we detected GAD-specific IL-13 +  CD4 T cell responses significantly more frequently in participants immunised with GAD-alum (71% and 94% treated twice or three times, respectively) compared with those immunised with alum alone (38%; p = 0.003 and p = 0.0002, respectively) accompanied by high secreted levels of IL-13, IL-4 and IL-5, confirming a GAD-specific, GAD-alum-induced Th2 response.",[],"['aluminium hydroxide (GAD-alum', 'placebo', 'GAD-alum immunotherapy']","['GAD-specific IL-13 +  CD4 T cell responses', 'IL-13, IL-4 and IL-5, confirming a GAD-specific, GAD-alum-induced Th2 response', 'GAD-specific, IL-13 +  CD4 T cells', 'GAD-specific T cell responses', 'IL13 and IFNG expression', 'T cell receptor β-chain (TCRB']",[],"[{'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C0051522', 'cui_str': 'aluminum sulfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0214743', 'cui_str': 'Interleukin 13'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0051522', 'cui_str': 'aluminum sulfate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0034790', 'cui_str': 'T-cell antigen receptor'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0087049', 'cui_str': 'T-Cell Receptors beta-Chain'}]",,0.0923879,"At day 91 post immunisation, we detected GAD-specific IL-13 +  CD4 T cell responses significantly more frequently in participants immunised with GAD-alum (71% and 94% treated twice or three times, respectively) compared with those immunised with alum alone (38%; p = 0.003 and p = 0.0002, respectively) accompanied by high secreted levels of IL-13, IL-4 and IL-5, confirming a GAD-specific, GAD-alum-induced Th2 response.","[{'ForeName': 'Sefina', 'Initials': 'S', 'LastName': 'Arif', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Iria', 'Initials': 'I', 'LastName': 'Gomez-Tourino', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Yogesh', 'Initials': 'Y', 'LastName': 'Kamra', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Pujol-Autonell', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hanton', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Tree', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Melandri', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hull', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Wherrett', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Beam', 'Affiliation': 'Homer Stryker MD School of Medicine, Western Michigan University, Kalamazoo, MI, USA.'}, {'ForeName': 'Bart O', 'Initials': 'BO', 'LastName': 'Roep', 'Affiliation': 'Diabetes and Metabolism Research Institute, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lorenc', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Peakman', 'Affiliation': ""Peter Gorer Department of Immunobiology, King's College London Faculty of Life Sciences and Medicine, 2nd Floor, Borough Wing, Guy's Hospital, London, SE1 9RT, UK. mark.peakman@kcl.ac.uk.""}]",Diabetologia,['10.1007/s00125-020-05130-7']
717,32247714,Effect of Intermittent or Continuous Feed on Muscle Wasting in Critical Illness: A Phase 2 Clinical Trial.,"BACKGROUND


Acute skeletal muscle wasting in critical illness is associated with excess morbidity and mortality. Continuous feeding may suppress muscle protein synthesis as a result of the muscle-full effect, unlike intermittent feeding, which may ameliorate it.
RESEARCH QUESTION


Does intermittent enteral feed decrease muscle wasting compared with continuous feed in critically ill patients?
STUDY DESIGN AND METHODS


In a phase 2 interventional single-blinded randomized controlled trial, 121 mechanically ventilated adult patients with multiorgan failure were recruited following prospective informed consultee assent. They were randomized to the intervention group (intermittent enteral feeding from six 4-hourly feeds per 24 h, n = 62) or control group (standard continuous enteral feeding, n = 59). The primary outcome was 10-day loss of rectus femoris muscle cross-sectional area determined by ultrasound. Secondary outcomes included nutritional target achievements, plasma amino acid concentrations, glycemic control, and physical function milestones.
RESULTS


Muscle loss was similar between arms (-1.1% [95% CI, -6.1% to -4.0%]; P = .676). More intermittently fed patients received 80% or more of target protein (OR, 1.52 [1.16-1.99]; P < .001) and energy (OR, 1.59 [1.21-2.08]; P = .001). Plasma branched-chain amino acid concentrations before and after feeds were similar between arms on trial day 1 (71 μM [44-98 μM]; P = .547) and trial day 10 (239 μM [33-444 μM]; P = .178). During the 10-day intervention period the coefficient of variation for glucose concentrations was higher with intermittent feed (17.84 [18.6-20.4]) vs continuous feed (12.98 [14.0-15.7]; P < .001). However, days with reported hypoglycemia and insulin usage were similar in both groups. Safety profiles, gastric intolerance, physical function milestones, and discharge destinations did not differ between groups.
INTERPRETATION


Intermittent feeding in early critical illness is not shown to preserve muscle mass in this trial despite resulting in a greater achievement of nutritional targets than continuous feeding. However, it is feasible and safe.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT02358512; URL: www.clinicaltrials.gov.",2020,Plasma branched-chain amino acid concentrations before and after feeds were similar between arms on trial day 1 (71 μM (44-98); p=0.547) and trial day 10 (239 μM (33-444); p=0.178).,"['121 mechanically-ventilated adult patients with multi-organ failure', 'muscle wasting in critical illness', 'critically ill patients']","['intermittent or continuous feed', 'control group (standard continuous enteral feeding']","['Safety profiles, gastric intolerance, physical function milestones and discharge destinations', 'Plasma branched-chain amino acid concentrations', 'hypoglycaemia and insulin usage', 'Muscle loss', 'coefficient of variation for glucose concentrations', 'nutritional target achievements, plasma amino acid concentrations, glycaemic control and physical function milestones', 'day loss of rectus femoris muscle cross-sectional area determined by ultrasound']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",121.0,0.179377,Plasma branched-chain amino acid concentrations before and after feeds were similar between arms on trial day 1 (71 μM (44-98); p=0.547) and trial day 10 (239 μM (33-444); p=0.178).,"[{'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'McNelly', 'Affiliation': 'William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom; University College London (UCL), London, United Kingdom; National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at UCL Hospitals NHS Foundation Trust and University College London, London, United Kingdom. Electronic address: angela.mcnelly@qmul.ac.uk.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Bear', 'Affiliation': ""Department of Nutrition and Dietetics, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom; Department of Critical Care, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom; NIHR BRC, King's College London (KCL), London, United Kingdom.""}, {'ForeName': 'Bronwen A', 'Initials': 'BA', 'LastName': 'Connolly', 'Affiliation': ""NIHR BRC, King's College London (KCL), London, United Kingdom; Lane Fox Clinical Respiratory Physiology Research Centre, Guy's and St Thomas' NHS Foundation Trust.""}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Arbane', 'Affiliation': ""Lane Fox Clinical Respiratory Physiology Research Centre, Guy's and St Thomas' NHS Foundation Trust.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Allum', 'Affiliation': ""Lane Fox Clinical Respiratory Physiology Research Centre, Guy's and St Thomas' NHS Foundation Trust.""}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Tarbhai', 'Affiliation': 'University College London (UCL), London, United Kingdom.'}, {'ForeName': 'Jackie A', 'Initials': 'JA', 'LastName': 'Cooper', 'Affiliation': 'University College London (UCL), London, United Kingdom.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Hopkins', 'Affiliation': 'Kings College Hospital, London, United Kingdom.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Wise', 'Affiliation': 'University Hospital of Wales, Cardiff, Wales, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brealey', 'Affiliation': 'National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at UCL Hospitals NHS Foundation Trust and University College London, London, United Kingdom.'}, {'ForeName': 'Kieron', 'Initials': 'K', 'LastName': 'Rooney', 'Affiliation': 'Bristol Royal Infirmary, Bristol, United Kingdom.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Cupitt', 'Affiliation': 'Blackpool Victoria Hospital, Blackpool, United Kingdom.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Carr', 'Affiliation': 'University Hospitals of North Midlands, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Koelfat', 'Affiliation': 'Department of Surgery and School of Nutrition and Translational Research in Metabolism (NUTRIM), University of Maastricht, Maastricht, The Netherlands.'}, {'ForeName': 'Steven Olde', 'Initials': 'SO', 'LastName': 'Damink', 'Affiliation': 'Department of Surgery and School of Nutrition and Translational Research in Metabolism (NUTRIM), University of Maastricht, Maastricht, The Netherlands; Department of General, Visceral and Transplantation Surgery, RWTH University Hospital Aachen, Aachen, Germany.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'Medical Research Council/Arthritis Research UK Centre for Musculoskeletal Aging, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hart', 'Affiliation': ""Lane Fox Clinical Respiratory Physiology Research Centre, Guy's and St Thomas' NHS Foundation Trust.""}, {'ForeName': 'Hugh E', 'Initials': 'HE', 'LastName': 'Montgomery', 'Affiliation': 'University College London (UCL), London, United Kingdom; National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at UCL Hospitals NHS Foundation Trust and University College London, London, United Kingdom.'}, {'ForeName': 'Zudin A', 'Initials': 'ZA', 'LastName': 'Puthucheary', 'Affiliation': 'Adult Critical Care Unit, Royal London Hospital, London, United Kingdom; William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}]",Chest,['10.1016/j.chest.2020.03.045']
718,31764105,Association between HIV antiretroviral therapy and preterm birth based on antenatal ultrasound gestational age determination: a comparative analysis.,"OBJECTIVE


To evaluate the association between HIV antiretroviral therapy (ART) and preterm birth (PTB), when defined by gold standard antenatal ultrasound versus newborn exam.
DESIGN


A secondary analysis of the PROMISE 1077BF/1077FF randomized controlled trial, which compared antiretroviral strategies to reduce perinatal HIV transmission and improve maternal health. The trial used newborn exam (i.e. New Ballard Score, NBS) to assess gestational age. This analysis included liveborn singleton pregnancies with both newborn exam and ultrasound data. The primary exposure was the trial's antiretroviral strategies: zidovudine with intrapartum nevirapine ('ZDV alone'); zidovudine/lamivudine/lopinavir-ritonavir ('ZDV-based ART'); or tenofovir/emtricitabine/lopinavir-ritonavir ('TDF-based ART'). The primary outcome was PTB less than 37 and less than 34 weeks based on the gold standard of ultrasound dating. We evaluated the association between antiretroviral strategy and PTB. We fit multivariable logistic regression models, adjusting for maternal characteristics, obstetric history, and HIV disease severity.
RESULTS


Among 720 assessed pregnant women, PTB less than 37 weeks was 15.4% by NBS and 18.3% by ultrasound. The NBS was specific but not sensitive for PTB less than 37 weeks (92.0% and 48.5%). Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks. These results held for ultrasounds performed less than 24 weeks, and were generally consistent with prior analyses from the PROMISE trial using the NBS.
CONCLUSION


Women starting HIV ART in pregnancy remained at higher risk of PTB when determined by ultrasound, consistent with prior data using newborn exam. However, newborn exam misclassified cases of PTB compared with gold standard ultrasound.",2019,"Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks.",['liveborn singleton pregnancies with both newborn exam and ultrasound data'],"['HIV antiretroviral therapy (ART) and preterm birth (PTB', 'ZDV', ""zidovudine with intrapartum nevirapine ('ZDV alone'); zidovudine/lamivudine/lopinavir-ritonavir ('ZDV-based ART'); or tenofovir/emtricitabine/lopinavir-ritonavir ('TDF-based ART""]",['perinatal HIV transmission and improve maternal health'],"[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}]",720.0,0.198607,"Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks.","[{'ForeName': 'Kartik Kailas', 'Initials': 'KK', 'LastName': 'Venkatesh', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Farhad', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Fenton', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Centre for AIDS Research in South Africa and Department of Obstetrics and Gynecology, School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Naik', 'Affiliation': 'Byramiee Jeejeebhoy Government Medical College, Pune, India.'}, {'ForeName': 'Clemensia', 'Initials': 'C', 'LastName': 'Nakabiito', 'Affiliation': 'Makerere University, Kampala, Uganda.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.""}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Chi', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.""}]","AIDS (London, England)",['10.1097/QAD.0000000000002367']
719,31795035,Stability of frontal alpha asymmetry in depressed patients during antidepressant treatment.,"INTRODUCTION


Frontal alpha asymmetry (FAA) is a proposed prognostic biomarker in major depressive disorder (MDD), conventionally acquired with electroencephalography (EEG). Although small studies attributed trait-like properties to FAA, a larger sample is needed to reliably asses this characteristic. Furthermore, to use FAA to predict treatment response, determining its stability, including the potential dependency on depressive state or medication, is essential.
METHODS


In the international Study to Predict Optimized Treatment in Depression (iSPOT-D), a multi-center, randomized, prospective open-label trial, 1008 MDD participants were randomized to treatment with escitalopram, sertraline or venlafaxine-extended release. Treatment response was established eight weeks after treatment initiation and resting state EEG was measured both at baseline and after eight weeks (n = 453).
RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity. After randomizing females to escitalopram or sertraline, for whom treatment response could be predicted in an earlier study, FAA after eight weeks resulted in equivalent response prediction as baseline FAA (one tailed p = .028).
CONCLUSION


We demonstrate that FAA is a stable trait, robust to time, state and pharmacological status. This confirms FAA stability. Furthermore, as prediction of treatment response is irrespective of moment of measurement and use of medication, FAA can be used as a state-invariant prognostic biomarker with promise to optimize MDD treatments.",2019,"RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity.","['1008 MDD participants', 'depressed patients during antidepressant treatment']","['escitalopram, sertraline or venlafaxine-extended release', 'FAA', 'Frontal alpha asymmetry (FAA', 'sertraline']","['resting state EEG', 'Stability of frontal alpha asymmetry']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]",1008.0,0.02721,"RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity.","[{'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'van der Vinne', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Synaeda Psycho Medisch Centrum, Leeuwarden, The Netherlands; Department of Clinical Neurophysiology, Technical Medical Centre, University of Twente, Enschede, The Netherlands. Electronic address: n.van.der.vinne@synaeda.nl.'}, {'ForeName': 'Madelon A', 'Initials': 'MA', 'LastName': 'Vollebregt', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Michel J A M', 'Initials': 'MJAM', 'LastName': 'van Putten', 'Affiliation': 'Department of Clinical Neurophysiology, Technical Medical Centre, University of Twente, Enschede, The Netherlands; Department of Clinical Neurophysiology and Neurology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Department of Experimental Psychology, Utrecht University, Utrecht, The Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102056']
720,31795041,Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder.,"Real-time functional magnetic resonance imaging (fMRI) neurofeedback training of amygdala hemodynamic activity directly targets a neurobiological mechanism, which contributes to emotion regulation problems in borderline personality disorder (BPD). However, it remains unknown which outcome measures can assess changes in emotion regulation and affective instability, associated with amygdala downregulation in a clinical trial. The current study directly addresses this question. Twenty-four female patients with a DSM-IV BPD diagnosis underwent four runs of amygdala neurofeedback. Before and after the training, as well as at a six-weeks follow-up assessment, participants completed measures of emotion dysregulation and affective instability at diverse levels of analysis (verbal report, clinical interview, ecological momentary assessment, emotion-modulated startle, heart rate variability, and fMRI). Participants were able to downregulate their amygdala blood oxygen-dependent (BOLD) response with neurofeedback. There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training. Further explorative analyses suggest that patients indicated less affective instability, as seen by lower hour-to-hour variability in negative affect and inner tension in daily life. If replicated by an independent study, our results imply changes in emotion regulation and affective instability for several systems levels, including behavior and verbal report. Conclusions are limited due to the lack of a control group. A randomized controlled trial (RCT) will be needed to confirm effectiveness of the training.",2019,There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training.,"['patients with borderline personality disorder', 'borderline personality disorder (BPD', 'Twenty-four female patients with a DSM-IV BPD diagnosis underwent four runs of amygdala neurofeedback']",[],"['emotion-modulated startle to negative pictures', 'emotion regulation and affective instability', 'amygdala blood oxygen-dependent (BOLD) response with neurofeedback', 'affective instability', 'emotion dysregulation and affective instability at diverse levels of analysis (verbal report, clinical interview, ecological momentary assessment, emotion-modulated startle, heart rate variability, and fMRI', 'emotion regulation', 'Zanarini rating scale for BPD (ZAN-BPD', 'BPD symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0460109', 'cui_str': 'Verbal report'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",24.0,0.0423346,There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training.,"[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Zaehringer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany. Electronic address: jenny.zaehringer@zi-mannheim.de.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Ende', 'Affiliation': 'Department Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim / University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Santangelo', 'Affiliation': 'Chair of Applied Psychology/Mental Health Lab, Institute of Sport and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Kleindienst', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Ruf', 'Affiliation': 'Department Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim / University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bertsch', 'Affiliation': 'Department for General Psychiatry, Center of Psychosocial Medicine, University of Heidelberg, Heidelberg, Germany; Department of Psychology, LMU Munich, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bohus', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmahl', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Paret', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany; Sagol Brain Institute, Wohl Institute for Advanced Imaging, Tel-Aviv Sourasky Medical Center and School of Psychological Sciences, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: christian.paret@zi-mannheim.de.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102032']
721,32250331,Dose and staffing comparison study of upper limb device-assisted therapy.,"BACKGROUND


Neurological injuries cause persistent upper extremity motor deficits. Device-assisted therapy is an emerging trend in neuro-rehabilitation as it offers high intensity, repetitive practice in a standardized setting.
OBJECTIVE


To investigate the effects of therapy duration and staff-participant configuration on device-assisted upper limb therapy outcomes in individuals with chronic paresis.
METHODS


Forty-seven participants with chronic upper extremity weakness due to neurological injury were assigned to a therapy duration (30 or 60 min) and a staff-participant configuration (1-to-1 or 1-to-2). Therapy consisted of 3 sessions a week for 6 weeks using the Armeo®Spring device. Clinical assessments were performed at three timepoints (Pre, Post, and 3 month Follow up).
RESULTS


Improvements in upper limb impairment, measured by change in Fugl-Meyer score (FM), were observed following therapy in all groups. FM improvement was comparable between 30 and 60 min sessions, but participants in the 1-to-2 group had significantly greater improvement in FM from Pre-to-Post and from Pre-to-Follow up than the 1-to-1 group.
CONCLUSIONS


Device-assisted therapy can reduce upper limb impairment to a similar degree whether participants received 30 or 60 min per session. Our results suggest that delivering therapy in a 1-to-2 configuration is a feasible and more effective approach than traditional 1-to-1 staffing.",2020,"RESULTS


Improvements in upper limb impairment, measured by change in Fugl-Meyer score (FM), were observed following therapy in all groups.","['Forty-seven participants with chronic upper extremity weakness due to neurological injury', 'individuals with chronic paresis']","['Device-assisted therapy', 'upper limb device-assisted therapy']","['FM', 'upper limb impairment', 'Fugl-Meyer score (FM', 'FM improvement']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0751792', 'cui_str': 'Injury of nervous system'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",47.0,0.0446229,"RESULTS


Improvements in upper limb impairment, measured by change in Fugl-Meyer score (FM), were observed following therapy in all groups.","[{'ForeName': 'Marissa J', 'Initials': 'MJ', 'LastName': 'Wuennemann', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Stuart W', 'Initials': 'SW', 'LastName': 'Mackenzie', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Heather Pepper', 'Initials': 'HP', 'LastName': 'Lane', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Avrielle R', 'Initials': 'AR', 'LastName': 'Peltz', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Healthcare Policy & Research, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Gerber', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Healthcare Policy & Research, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Dylan J', 'Initials': 'DJ', 'LastName': 'Edwards', 'Affiliation': 'Moss Rehabilitation Research Institute, Elkins Park, PA, USA.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kitago', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}]",NeuroRehabilitation,['10.3233/NRE-192993']
722,32250328,"Effects of dynamic core-postural chain stabilization on diaphragm movement, abdominal muscle thickness, and postural control in patients with subacute stroke: A randomized control trial.","BACKGROUND


Neurodevelopmental treatment (NDT) and Dynamic neuromuscular stabilization (DNS)-based exercise is effective for improving core stability and postural control in stroke patients.
OBJECTIVE


To compare the effects of DNS and conventional NDT exercises on diaphragm movement, abdominal muscle thickness, and postural control in stroke patients.
METHODS


The participants were randomly allocated into DNS (n = 16) and NDT (n = 15) for 30 minutes each per day, 3 days a week for 4 weeks. Diaphragm movement and abdominal muscle thickness were determined using ultrasonography. The trunk impairment scale (TIS) and Berg Balance Scale (BBS) were used to measure postural control. The functional ambulation category (FAC) was used to evaluate gait ability. Analysis of covariance (ANCOVA) was used to evaluate post-test differences in the DNS and NDT exercise groups.
RESULTS


ANCOVA revealed the superior effects of DNS in diaphragm movement and abdominal muscle thickness (transversus abdominis, internal oblique), as well as clinical BBS and FAC tests, compared with those of NDT (p < 0.05).
CONCLUSIONS


This novel clinical trial suggests that DNS training was more effective than NDT training in improving postural movement control and gait ability via a balanced co-activation of the diaphragm and TrA/IO in stroke patients.",2020,"Analysis of covariance (ANCOVA) was used to evaluate post-test differences in the DNS and NDT exercise groups.
","['patients with subacute stroke', 'stroke patients']","['DNS and conventional NDT exercises', 'NDT training', 'dynamic core-postural chain stabilization', 'Neurodevelopmental treatment (NDT) and Dynamic neuromuscular stabilization (DNS)-based exercise', 'DNS training', 'DNS', 'NDT']","['functional ambulation category (FAC', 'trunk impairment scale (TIS) and Berg Balance Scale (BBS', 'diaphragm movement and abdominal muscle thickness (transversus abdominis, internal oblique), as well as clinical BBS and FAC tests', 'postural movement control and gait ability', 'diaphragm movement, abdominal muscle thickness, and postural control', 'Diaphragm movement and abdominal muscle thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C2314896', 'cui_str': 'FAMMM'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0054427', 'cui_str': 'CAF protocol'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0000739', 'cui_str': 'Skeletal muscle structure of abdomen'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0224376', 'cui_str': 'Internal Oblique Muscle'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0427083', 'cui_str': 'Control of movement'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",,0.040415,"Analysis of covariance (ANCOVA) was used to evaluate post-test differences in the DNS and NDT exercise groups.
","[{'ForeName': 'Hyun Sik', 'Initials': 'HS', 'LastName': 'Yoon', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Young Joo', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, Movement Healing Laboratory, The Graduate School, Yonsei University, Wonju, Republic of Korea.'}, {'ForeName': 'Joshua Sung Hyun', 'Initials': 'JSH', 'LastName': 'You', 'Affiliation': 'Department of Physical Therapy, Movement Healing Laboratory, The Graduate School, Yonsei University, Wonju, Republic of Korea.'}]",NeuroRehabilitation,['10.3233/NRE-192983']
723,32250330,"Testosterone replacement in hypogonadal men during inpatient rehabilitation following traumatic brain injury: Results from a double-blind, placebo-controlled clinical pilot study.","BACKGROUND


Endocrinopathy, including hypogonadism, is common following traumatic brain injury (TBI). Prior evidence suggests hypogonadism is associated with poorer function.
OBJECTIVE


Determine the feasibility, safety, and efficacy of testosterone (T) therapy in hypogonadal men following TBI in acute rehabilitation.
DESIGN


Randomized, double blind, placebo-controlled pilot trial.
SETTING


Inpatient rehabilitation brain injury unit.
PARTICIPANTS


Men ages 18 -65, post moderate to severe TBI receiving inpatient rehabilitation.
INTERVENTIONS


Transdermal T gel or placebo.
MAIN OUTCOME MEASURES


Revised FIM™ score, strength, adverse events.
RESULTS


Of 498 screened, 70 participants were enrolled, and 22 meeting all criteria were randomized into placebo (n = 10) or physiologic T therapy (n = 12). There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, or slopes t = 0.61, p = 0.5472). The Treatment group demonstrated the greatest absolute improvement in FIM™ scores and grip strength compared to Placebo or Normal T groups. There was no difference in adverse events between groups. Percentage of time with agitation or aggression was highest in the Placebo group.
CONCLUSIONS


Although there were no significant differences in rates of recovery, treatment group subjects showed greater absolute functional and strength improvement compared to the Placebo or Normal T groups.",2020,"There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, slopes t = 0.61, p = 0.5472).","['Inpatient rehabilitation brain injury unit', 'Of 498 screened, 70 participants were enrolled, and 22 meeting all criteria were randomized into', 'Men ages 18 -65, post moderate to severe TBI receiving inpatient rehabilitation', 'hypogonadal men following TBI in acute rehabilitation', 'hypogonadal men during inpatient rehabilitation following traumatic brain injury']","['Testosterone replacement', 'placebo', 'testosterone (T) therapy', 'Transdermal T gel or placebo', 'Placebo', 'physiologic T therapy']","['FIM™ scores and grip strength', 'Percentage of time with agitation or aggression', 'feasibility, safety, and efficacy', 'absolute functional and strength improvement', 'adverse events', 'FIM™', 'Revised FIM™ score, strength, adverse events', 'rates of recovery']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",70.0,0.707248,"There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, slopes t = 0.61, p = 0.5472).","[{'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Ripley', 'Affiliation': 'Shirley Ryan Ability Lab, Chicago, IL, USA.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Gerber', 'Affiliation': 'Craig Hospital, Englewood, CO, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pretz', 'Affiliation': 'Lead Biostatistician, Johnson and Johnson, Irvine, CA, USA.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Weintraub', 'Affiliation': 'Craig Hospital, Englewood, CO, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Wierman', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, and Rocky Mountain Regional Veterans Affairs Research Service, Aurora, CO, USA.'}]",NeuroRehabilitation,['10.3233/NRE-192992']
724,32244279,"Vitamin B12 is Low in Milk of Early Postpartum Women in Urban Tanzania, and was not Significantly Increased by High dose Supplementation.","The effect of maternal multivitamin supplementation on breast milk vitamin B12 concentrations has not been examined in Tanzania, where the prevalence of maternal plasma B12 insufficiency is 25.6%. Multivitamins (containing 50 µg vitamin B12) or placebo were provided during pregnancy and in the postpartum period. Breast milk samples were collected at or around six weeks postpartum from 491 participants in a trial of multivitamins (NCT00197548). Linear and logistic regression models were used to examine the effect of supplements on vitamin B12 concentration in milk and its associations with other variables including potential confounders. Median vitamin B12 concentration in breast milk was 206 pmol/L and 70% of women had levels indicating inadequacy (<310 pmol/L). Multivitamin supplements did not significantly reduce the odds of inadequate vitamin B12 in breast milk, suggesting suboptimal absorption. A single unit increase in maternal hemoglobin at six weeks was associated with 18% lower odds of inadequate vitamin B12 in breast milk. Participants with higher BMI at baseline had double the odds of having inadequate vitamin B12 than the reference group (<22 kg/m 2 ). Trials to determine the optimal dose, route, and duration of supplementation to improve maternal B12 status in Sub-Saharan Africa are of utmost importance.",2020,Participants with higher BMI at baseline had double the odds of having inadequate vitamin B12 than the reference group (<22 kg/m 2 ).,[],"['maternal multivitamin supplementation', 'Multivitamin supplements', 'Multivitamins (containing 50 µg vitamin B12) or placebo']","['Median vitamin B12 concentration', 'maternal hemoglobin', 'maternal B12 status']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",491.0,0.219356,Participants with higher BMI at baseline had double the odds of having inadequate vitamin B12 than the reference group (<22 kg/m 2 ).,"[{'ForeName': 'Omar N', 'Initials': 'ON', 'LastName': 'Lweno', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Center, P.O. Box 74 Bagamoyo, Tanzania.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Sudfeld', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Hertzmark', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'Karim P', 'Initials': 'KP', 'LastName': 'Manji', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, P.O. Box 65001 Dar-es-Salaam, Tanzania.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, P.O. Box 65001 Dar-es-Salaam, Tanzania.'}, {'ForeName': 'Ramadhani A', 'Initials': 'RA', 'LastName': 'Noor', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'Honorati', 'Initials': 'H', 'LastName': 'Masanja', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Center, P.O. Box 74 Bagamoyo, Tanzania.'}, {'ForeName': 'Nahya', 'Initials': 'N', 'LastName': 'Salim', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, P.O. Box 65001 Dar-es-Salaam, Tanzania.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Shahab-Ferdows', 'Affiliation': 'USDA ARS Western Human Nutrition Research Centre, University of California Davis, CA 95616, USA.'}, {'ForeName': 'Lindsay H', 'Initials': 'LH', 'LastName': 'Allen', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Wafaie W', 'Initials': 'WW', 'LastName': 'Fawzi', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.'}]",Nutrients,['10.3390/nu12040963']
725,32244368,A Prospective Pilot Trial to Assess the Efficacy of Argatroban (Argatra ® ) in Critically Ill Patients with Heparin Resistance.,"The current study aims to evaluate whether prophylactic anticoagulation using argatroban or an increased dose of unfractionated heparin (UFH) is effective in achieving the targeted activated partial thromboplastin time (aPTT) of more than 45 s in critically ill heparin-resistant (HR) patients. Patients were randomized either to continue receiving an increased dose of UFH, or to be treated with argatroban. The endpoints were defined as achieving an aPTT target of more than 45 s at 7 h and 24 h. This clinical trial was registered on clinicaltrials.gov (NCT01734252) and on EudraCT (2012-000487-23). A total of 42 patients, 20 patients in the heparin and 22 in the argatroban group, were included. Of the patients with continued heparin treatment 55% achieved the target aPTT at 7 h, while only 40% of this group maintained the target aPTT after 24 h. Of the argatroban group 59% reached the target aPTT at 7 h, while at 24 h 86% of these patients maintained the targeted aPTT. Treatment success at 7 h did not differ between the groups ( p  = 0.1000), whereas at 24 h argatroban showed significantly greater efficacy ( p  = 0.0021) than did heparin. Argatroban also worked better in maintaining adequate anticoagulation in the further course of the study. There was no significant difference in the occurrence of bleeding or thromboembolic complications between the treatment groups. In the case of heparin-resistant critically ill patients, argatroban showed greater efficacy than did an increased dose of heparin in achieving adequate anticoagulation at 24 h and in maintaining the targeted aPTT goal throughout the treatment phase.",2020,"Treatment success at 7 h did not differ between the groups ( p  = 0.1000), whereas at 24 h argatroban showed significantly greater efficacy ( p  = 0.0021) than did heparin.","['42 patients, 20 patients in the heparin and 22 in the argatroban group, were included', 'critically ill heparin-resistant (HR) patients', 'Critically Ill Patients with Heparin Resistance']","['UFH, or to be treated with argatroban', 'heparin', 'Argatroban (Argatra ® ', 'Argatroban', 'argatroban', 'EudraCT', 'unfractionated heparin (UFH']","['occurrence of bleeding or thromboembolic complications', 'Treatment success', 'efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0048470', 'cui_str': 'argatroban'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1167838', 'cui_str': 'Heparin resistance'}]","[{'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0048470', 'cui_str': 'argatroban'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",42.0,0.0298231,"Treatment success at 7 h did not differ between the groups ( p  = 0.1000), whereas at 24 h argatroban showed significantly greater efficacy ( p  = 0.0021) than did heparin.","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Bachler', 'Affiliation': 'Institute for Sports Medicine, Alpine Medicine and Health Tourism, UMIT-University for Health Sciences, Medical Informatics and Technology, 6060 Hall in Tirol, Austria.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hell', 'Affiliation': 'Department of Mathematics, Faculty of Mathematics, Computer Science and Physics, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bösch', 'Affiliation': 'Department of General and Surgical Critical Care Medicine, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Treml', 'Affiliation': 'Department of General and Surgical Critical Care Medicine, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Schenk', 'Affiliation': 'Department of General and Surgical Critical Care Medicine, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Treichl', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Friesenecker', 'Affiliation': 'Department of General and Surgical Critical Care Medicine, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Lorenz', 'Affiliation': 'Department of General and Surgical Critical Care Medicine, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stengg', 'Affiliation': 'Department of General and Surgical Critical Care Medicine, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hruby', 'Affiliation': 'Department of General and Surgical Critical Care Medicine, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wallner', 'Affiliation': 'Department of General and Surgical Critical Care Medicine, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Elgar', 'Initials': 'E', 'LastName': 'Oswald', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ströhle', 'Affiliation': 'Department of General and Surgical Critical Care Medicine, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Niederwanger', 'Affiliation': 'Department of Pediatrics, Pediatrics I, Intensive Care Unit, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Irsara', 'Affiliation': 'Central Institute for Medical and Chemical Laboratory Diagnostics, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Fries', 'Affiliation': 'Department of General and Surgical Critical Care Medicine, Medical University of Innsbruck, 6020 Innsbruck, Austria.'}]",Journal of clinical medicine,['10.3390/jcm9040963']
726,32244696,Effect of Two Meal Replacement strategies on Cardiovascular Risk Parameters in Advanced Age Patients with Obesity and Osteoarthritis.,"BACKGROUND AND AIMS


Meal replacement diets consist of replacing one or more meals with an artificial nutritional supplement. The objective of this study was to compare the effect of one against two meal replacement strategies on body composition and cardiovascular risk parameters in patients with obesity.
METHODS


A randomized clinical trial was designed with a modified hypocaloric diet with an artificial nutritional preparation replacing one or two meals for three months in patients with obesity and osteoarthritis pending orthopedic surgery. An anthropometric evaluation and a measurement of the body composition were done with bioelectrical impedance measurement at the beginning and at three months.
RESULTS


A total of 112 patients were recruited. Fifty-two patients (46.4%) were randomized to one replacement and 60 patients (53.6%) to two meal replacements. Eighty-one patients (72.3%) were women, and the average age was 61 (11.03) years. The percentage of weight loss at three months was 8.27 (4.79)% (one meal replacement: 7.98 (5.97)%; two meal replacements: 8.50 (3.48)%;  p  = 0.56). A decrease in fat mass measured by the fat mass index (FMI) was detected (one meal replacement: -2.15 (1.45) kg/m 2  vs. two meal replacements: -2.78 (2.55) kg/m 2 ;  p  > 0.05), and a relative increase in fat-free mass was observed (one meal replacement: +3.57 (4.61)% vs. two meal replacements: +2.14 (4.45)%;  p  > 0.05). A decrease in HOMA-IR, systolic blood pressure (SBP), and total cholesterol was observed in both groups without differences between them.
CONCLUSIONS


The substitution strategies of one or two meal replacements were effective in weight loss and fat mass decrease without differences between the two groups. An improvement in lipid parameters, glycemic control, and systolic blood pressure was observed without differences between strategies.",2020,The substitution strategies of one or two meal replacements were effective in weight loss and fat mass decrease without differences between the two groups.,"['A total of 112 patients were recruited', 'patients with obesity and osteoarthritis pending orthopedic surgery', 'Advanced Age Patients with Obesity and Osteoarthritis', 'Fifty-two patients (46.4', 'Eighty-one patients (72.3%) were women, and the average age was 61 (11.03) years', 'patients with obesity']","['meal replacement strategies', 'modified hypocaloric diet', 'Two Meal Replacement strategies']","['percentage of weight loss', 'fat-free mass', 'lipid parameters, glycemic control, and systolic blood pressure', 'fat mass', 'weight loss and fat mass decrease', 'fat mass index (FMI', 'body composition and cardiovascular risk parameters', 'Cardiovascular Risk Parameters', 'HOMA-IR, systolic blood pressure (SBP), and total cholesterol']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",112.0,0.0372317,The substitution strategies of one or two meal replacements were effective in weight loss and fat mass decrease without differences between the two groups.,"[{'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'López-Gómez', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valladolid, Av. Ramón y Cajal, 3, 47003 Valladolid, Spain.'}, {'ForeName': 'Olatz', 'Initials': 'O', 'LastName': 'Izaola-Jauregui', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valladolid, Av. Ramón y Cajal, 3, 47003 Valladolid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Primo-Martín', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valladolid, Av. Ramón y Cajal, 3, 47003 Valladolid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Torres-Torres', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valladolid, Av. Ramón y Cajal, 3, 47003 Valladolid, Spain.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Gómez-Hoyos', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valladolid, Av. Ramón y Cajal, 3, 47003 Valladolid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortolá-Buigues', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valladolid, Av. Ramón y Cajal, 3, 47003 Valladolid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Martín-Ferrero', 'Affiliation': 'Servicio de Traumatología, Hospital Clínico Universitario de Valladolid, Av. Ramón y Cajal, 3, 47003 Valladolid, Spain.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'De Luis-Román', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valladolid, Av. Ramón y Cajal, 3, 47003 Valladolid, Spain.'}]",Nutrients,['10.3390/nu12040976']
727,32244777,EMS-effect of Exercises with Music on Fatness and Biomarkers of Obese Elderly Women.,"Background and objectives:  Electromyostimulation (EMS) has been shown to improve body composition, but what biomarkers it affects has not been investigated. The purpose of this study was to compare the EMS-effect of exercises with music on fatness and biomarker levels in obese elderly.  Materials and Methods:  Twenty-five women were randomly classified into a control group (CON) and EMS group (EMSG). EMS suits used in this study enabled the simultaneous activation of eight pairs with selectable intensities. Program sessions of EMS were combined with exercises of listening to music three times a week for eight weeks. Although both groups received the same program, CON did not receive electrical stimuli.  Results:  Compared with CON, a significant effect of the EMS intervention concerning decreased fatness, as well as an increased skeletal muscle mass and basal metabolic rate, were evident. Tumor necrosis factor-a, C-reactive protein, resistin, and carcinoembryonic antigen of biomarkers were significantly different in the groups by time interaction. Similarly, the positive changes caused by EMS were represented in lipoprotein-cholesterols.  Conclusions:  The results indicate that a significant effect due to the EMS intervention was found concerning body composition and biomarkers in obese elderly women.",2020,"Compared with CON, a significant effect of the EMS intervention concerning decreased fatness, as well as an increased skeletal muscle mass and basal metabolic rate, were evident.","['Obese Elderly Women', 'obese elderly women', 'obese elderly', 'Twenty-five women']","['Electromyostimulation (EMS', 'exercises with music', 'Exercises with Music', 'CON', 'control group (CON) and EMS group (EMSG', 'EMS intervention']","['Tumor necrosis factor-a, C-reactive protein, resistin, and carcinoembryonic antigen of biomarkers', 'skeletal muscle mass and basal metabolic rate', 'lipoprotein-cholesterols']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0542499', 'cui_str': 'Measurement of basal metabolic rate'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}]",25.0,0.0141086,"Compared with CON, a significant effect of the EMS intervention concerning decreased fatness, as well as an increased skeletal muscle mass and basal metabolic rate, were evident.","[{'ForeName': 'Jiyoun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Exercise Rehabilitation and Welfare, Gachon University, Hombakmoero, Yeonsu-gu, Incheon 406-799, Korea.'}, {'ForeName': 'Yongseok', 'Initials': 'Y', 'LastName': 'Jee', 'Affiliation': 'Department of Leisure and Marine Sports, Hanseo University, Hanseo 1-Ro, Haemi-myeon, Seosan 31962, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56040158']
728,32241625,Effect of virtual reality meditation on sleep quality of intensive care unit patients: A randomised controlled trial.,"OBJECTIVE


This study aimed to investigate the effect of virtual reality meditation on sleep quality of intensive care unit patients.
METHODS


This randomised controlled trial included 48 cardiac intensive care unit patients in a university hospital in Korea randomly allocated to the experimental (24) and the control group (24). For the experimental group, meditation was provided for 30 minutes using a head-mounted display for virtual reality, on the evening of the admission day.
MAIN OUTCOME MEASURES


The sleep quality of both groups was measured by self-report using Sleep Scale A and the activity tracker FitBit Charge 2.
RESULTS


The experimental group reported significantly higher subjective sleep quality than did the control group. Activity tracker assessment indicated that total sleep time and light sleep time did not differ between the groups. However, the awake time was shorter, deep sleep time was longer and sleep efficiency was significantly higher in the experimental group than in the control group.
CONCLUSION


Virtual reality meditation positively affected the sleep quality of intensive care unit patients. Critical care nurses should consider using virtual reality meditation as a nursing intervention to improve the patient's sleep quality.",2020,"However, the awake time was shorter, deep sleep time was longer and sleep efficiency was significantly higher in the experimental group than in the control group.
","['48 cardiac intensive care unit patients in a university hospital in Korea randomly allocated to the experimental (24) and the control group (24', 'intensive care unit patients']","['virtual reality meditation', 'Virtual reality meditation']","['subjective sleep quality', 'deep sleep time', 'awake time', 'self-report using Sleep Scale A and the activity tracker FitBit Charge 2', 'sleep efficiency', 'total sleep time and light sleep time', 'sleep quality']","[{'cui': 'C0587446', 'cui_str': 'Cardiac intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0278182', 'cui_str': 'Light sleep'}]",48.0,0.0787142,"However, the awake time was shorter, deep sleep time was longer and sleep efficiency was significantly higher in the experimental group than in the control group.
","[{'ForeName': 'Soon Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Cardiac Intensive Care Unit, Dong-A University Medical Center, Busan, South Korea.'}, {'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'College of Nursing, Dong-A University, Busan, South Korea. Electronic address: jykang@dau.ac.kr.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2020.102849']
729,32244628,Comparison of Post-Exercise Hypotension Responses in Paralympic Powerlifting Athletes after Completing Two Bench Press Training Intensities.,"Background and objective : Post-exercise hypotension, the reduction of blood pressure after a bout of exercise, is of great clinical relevance. Resistance exercise training is considered an important contribution to exercise training programs for hypertensive individuals and athletes. In this context, post-exercise hypotension could be clinically relevant because it would maintain blood pressure of hypertensive individuals transiently at lower levels during day-time intervals, when blood pressure is typically at its highest levels. The aim of this study was to compare the post-exercise cardiovascular effects on Paralympic powerlifting athletes of two typical high-intensity resistance-training sessions, using either five sets of five bench press repetitions at 90% 1 repetition maximum (1RM) or five sets of three bench press repetitions at 95% 1RM.  Materials and Methods : Ten national-level Paralympic weightlifting athletes (age: 26.1 ± 6.9 years; body mass: 76.8 ± 17.4 kg) completed the two resistance-training sessions, one week apart, in a random order.  Results : Compared with baseline values, a reduction of 5-9% in systolic blood pressure was observed after 90% and 95% of 1RM at 20-50 min post-exercise. Furthermore, myocardial oxygen volume and double product were only significantly increased immediately after and 5 min post-exercise, while the heart rate was significantly elevated after the resistance training but decreased to baseline level by 50 min after training for both training conditions.  Conclusions : A hypotensive response can be expected in elite Paralympic powerlifting athletes after typical high-intensity type resistance-training sessions.",2020,"Furthermore, myocardial oxygen volume and double product were only significantly increased immediately after and 5 min post-exercise, while the heart rate was significantly elevated after the resistance training but decreased to baseline level by 50 min after training for both training conditions.  ","['Paralympic Powerlifting Athletes', 'hypertensive individuals and athletes', 'elite Paralympic powerlifting athletes after typical high-intensity type resistance-training sessions', 'Paralympic powerlifting athletes of two typical high-intensity resistance-training sessions', 'Ten national-level Paralympic weightlifting athletes (age: 26.1 ± 6.9 years; body mass: 76.8 ± 17.4 kg) completed the two resistance-training sessions, one week apart, in a random order']","['Materials and Methods ', 'Resistance exercise training']","['blood pressure', 'systolic blood pressure', 'heart rate', 'myocardial oxygen volume and double product']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",,0.0609874,"Furthermore, myocardial oxygen volume and double product were only significantly increased immediately after and 5 min post-exercise, while the heart rate was significantly elevated after the resistance training but decreased to baseline level by 50 min after training for both training conditions.  ","[{'ForeName': 'Ângelo de Almeida', 'Initials': 'ÂA', 'LastName': 'Paz', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), 49100-000 São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Felipe José', 'Initials': 'FJ', 'LastName': 'Aidar', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), 49100-000 São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Dihogo Gama', 'Initials': 'DG', 'LastName': 'de Matos', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GEPEPS), the Federal University of Sergipe (UFS), 49100-000 São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Raphael Fabrício', 'Initials': 'RF', 'LastName': 'de Souza', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GEPEPS), the Federal University of Sergipe (UFS), 49100-000 São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Marzo Edir', 'Initials': 'ME', 'LastName': 'da Silva-Grigoletto', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), 49100-000 São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'van den Tillaar', 'Affiliation': 'Department of Sport Sciences and Physical Education, Nord University, 1490 8049 Levanger, Norway.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Department of Physical Activity Sciences, Universidad de Los Lagos, 14104 Osorno, Chile.'}, {'ForeName': 'Fábio Yuzo', 'Initials': 'FY', 'LastName': 'Nakamura', 'Affiliation': 'Department of Physical Education, Federal University of Paraíba-UFPB, 50670-901 João Pessoa, Paraíba, Brazil.'}, {'ForeName': 'Manoel da Cunha', 'Initials': 'MDC', 'LastName': 'Costa', 'Affiliation': 'Human Performance Laboratory, Pernambuco State University-(UPE), 50100-010 Recife, Pernambuco, Brazil.'}, {'ForeName': 'Albená', 'Initials': 'A', 'LastName': 'Nunes-Silva', 'Affiliation': 'Laboratory of Inflammation and Exercise Immunology, Sports Center, Federal University of Ouro Preto, 35400-000 Minas Gerais, Brazil.'}, {'ForeName': 'Anselmo de Athayde', 'Initials': 'AA', 'LastName': 'Costa E Silva', 'Affiliation': 'Department of Physical Education, Federal University of Pará (UFPA), 66075-110 Belém, Pará, Brazil.'}, {'ForeName': 'Anderson Carlos', 'Initials': 'AC', 'LastName': 'Marçal', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GEPEPS), the Federal University of Sergipe (UFS), 49100-000 São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Victor Machado', 'Initials': 'VM', 'LastName': 'Reis', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), Trás os Montes and Alto Douro University, 5001-801 Vila Real, Portugal.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56040156']
730,32246591,[Percutaneous versus open technique transpedicular fixation in patients with thoracolumbares type A fractures].,"INTRODUCTION


Percutaneous transpedicular fixation techniques are an emerging tool in the treatment of spinal trauma, however, their use is not fully accepted.
OBJECTIVE


Compare results in patients with traumatic vertebral fracture, treated with percutaneous transpedicular fixation surgery versus open transpedicular fixation.
MATERIAL AND METHODS


From January to December 2016, 15 patients with traumatic vertebral fracture were randomly divided into 2 groups, group A were six treated with percutaneous transpedicular fixation, group B were treated with open technique transpedicular fixation, three patients were eliminated. Transoperative bleeding, postoperative pain with the 24-hour and two-week postoperative visual scale, the six-week Oswestry lumbar pain disability index, and three, six, 12 and 24 months of postoperative control were evaluated.
RESULTS


The follow-up was 24 months. Statistically significant differences in transoperative bleeding (p 2.43E-05), EVA on the first day (p 0.0003), EVA at two weeks (p = 0.01) were reported in the Oswestry lumbar pain disability questionnaire at six weeks (p = 0.0007), three months (p = 0.005), six months (p = 0.005), 12 months (p = 0.01) and 24 months (p = 0.004), no significant differences were observed with respect to operating time (p = 0.12).
DISCUSSION


In our work we find that transoperative bleeding, postoperative pain and functional disability are significantly minor in the percutaneous transpedicular fixation group.",2019,"Statistically significant differences in transoperative bleeding (p 2.43E-05), EVA on the first day (p 0.0003), EVA at two weeks (p = 0.01) were reported in the Oswestry lumbar pain disability questionnaire at six weeks (p = 0.0007), three months (p = 0.005), six months (p = 0.005), 12 months (p = 0.01) and 24 months (p = 0.004), no significant differences were observed with respect to operating time (p = 0.12).
","['patients with thoracolumbares type A fractures', 'patients with traumatic vertebral fracture', 'From January to December 2016, 15 patients with traumatic vertebral fracture']","['percutaneous transpedicular fixation', 'open technique transpedicular fixation', 'percutaneous transpedicular fixation surgery versus open transpedicular fixation', 'Percutaneous versus open technique transpedicular fixation']","['transoperative bleeding, postoperative pain and functional disability', 'Transoperative bleeding, postoperative pain with the 24-hour and two-week postoperative visual scale, the six-week Oswestry lumbar pain disability index', 'EVA', 'transoperative bleeding', 'Oswestry lumbar pain disability questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0442371', 'cui_str': 'Transpedicular approach'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242686', 'cui_str': 'EVA'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",15.0,0.013929,"Statistically significant differences in transoperative bleeding (p 2.43E-05), EVA on the first day (p 0.0003), EVA at two weeks (p = 0.01) were reported in the Oswestry lumbar pain disability questionnaire at six weeks (p = 0.0007), three months (p = 0.005), six months (p = 0.005), 12 months (p = 0.01) and 24 months (p = 0.004), no significant differences were observed with respect to operating time (p = 0.12).
","[{'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Calleros-Hernández', 'Affiliation': 'Centro Médico (ISSEMyM) Instituto de Seguridad Social del Estado de México y Municipios, Toluca. Estado de México. México.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Valencia-Martínez', 'Affiliation': 'Servicio de Ortopedia, Centro Médico (ISSEMyM) Instituto de Seguridad Social del Estado de México y Municipios, Toluca. Estado de México. México.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Hardy-Pérez', 'Affiliation': 'Coordinador de investigación y estudios de Postgrado, Facultad de Medicina de la Universidad Autónoma del Estado de México UAEMex. Estado de México.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Granados-Agonizante', 'Affiliation': 'Servicio de Ortopedia, Centro Médico (ISSEMyM) Instituto de Seguridad Social del Estado de México y Municipios, Toluca. Estado de México. México.'}]",Acta ortopedica mexicana,[]
731,32084445,Reducing cardiovascular risk among people living with HIV: Rationale and design of the INcreasing Statin Prescribing in HIV Behavioral Economics REsearch (INSPIRE) randomized controlled trial.,"Cardiovascular disease (CVD) is a major cause of morbidity among people living with HIV (PLWH). Statins can safely and effectively reduce CVD risk in PLWH, but evidence-based statin therapy is under-prescribed in PLWH. Developed using an implementation science framework, INcreasing Statin Prescribing in HIV Behavioral Economics REsearch (INSPIRE) is a stepped-wedge cluster randomized trial that addresses organization-, clinician- and patient-level barriers to statin uptake in Los Angeles community health clinics serving racially and ethnically diverse PLWH. After assessing knowledge about statins and barriers to clinician prescribing and patient uptake, we will design, implement and measure the effectiveness of (1) educational interventions targeting leadership, clinicians, and patients, followed by (2) behavioral economics-informed clinician feedback on statin uptake. In addition, we will assess implementation outcomes, including changes in clinician acceptability of statin prescribing for PLWH, clinician acceptability of the education and feedback interventions, and cost of implementation.",2020,"In addition, we will assess implementation outcomes, including changes in clinician acceptability of statin prescribing for PLWH, clinician acceptability of the education and feedback interventions, and cost of implementation.","['people living with HIV', 'people living with HIV (PLWH']",['Statin'],"['clinician acceptability of statin prescribing for PLWH, clinician acceptability of the education and feedback interventions, and cost of implementation', 'cardiovascular risk']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",2.0,0.0964372,"In addition, we will assess implementation outcomes, including changes in clinician acceptability of statin prescribing for PLWH, clinician acceptability of the education and feedback interventions, and cost of implementation.","[{'ForeName': 'Sae', 'Initials': 'S', 'LastName': 'Takada', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, Department of Medicine, Geffen School of Medicine at University of California, Los Angeles (UCLA), Los Angeles, CA, USA.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Ober', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Noah J', 'Initials': 'NJ', 'LastName': 'Goldstein', 'Affiliation': 'UCLA Anderson School of Management, Los Angeles, CA, USA; Department of Psychology, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Tamara B', 'Initials': 'TB', 'LastName': 'Horwich', 'Affiliation': 'Division of Cardiology, Department of Medicine, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Mittman', 'Affiliation': 'Division of Health Services Research & Implementation Science, Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, CA, USA.'}, {'ForeName': 'Suzanne B', 'Initials': 'SB', 'LastName': 'Shu', 'Affiliation': 'UCLA Anderson School of Management, Los Angeles, CA, USA.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, Department of Medicine, Geffen School of Medicine at University of California, Los Angeles (UCLA), Los Angeles, CA, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Vijayan', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Soma', 'Initials': 'S', 'LastName': 'Wali', 'Affiliation': 'Department of Medicine, Olive View-UCLA Medical Center, Sylmar, CA, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Cunningham', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, Department of Medicine, Geffen School of Medicine at University of California, Los Angeles (UCLA), Los Angeles, CA, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Ladapo', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, Department of Medicine, Geffen School of Medicine at University of California, Los Angeles (UCLA), Los Angeles, CA, USA. Electronic address: JLadapo@mednet.ucla.edu.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.02.012']
732,32250336,Effects of aerobic training on physical activity in people with stroke: A randomized controlled trial.,"BACKGROUND


Individuals with stroke have low physical activity levels and spend high amount of time in low-energy expenditure activities.
OBJECTIVE


To investigate the effects of aerobic treadmill training on physical activity levels and time spent in low-energy expenditure activities (primary outcomes), as well as on cardiorespiratory fitness, endurance, depression, mobility, quality of life and participation (secondary outcomes) after stroke.
METHODS


A randomized controlled trial, with 22 adults with chronic stroke was performed. Experimental group: aerobic treadmill training at 60-80% of heart rate reserve.
CONTROL GROUP


outdoor-overground walking below 40% of heart rate reserve. Both groups: three 40 min sessions/week over 12 weeks. Outcomes were measured at baseline, post-training, and 16-week follow-up.
RESULTS


No changes in the primary outcomes were found for any of the groups. The experimental group showed greater improvements in quality of life at 16-week follow-up (13 points;95% CI:3.5-23). Both groups improved depression (2.2 points;95% CI:0.01-4.3), endurance (Six-minute walk test:31 m;95% CI:5.6-57, Incremental shuttle-walk test:55 m;95% CI:3.8-107), and mobility (0.12 m/s;95% CI:0.02-0.2).
CONCLUSION


Aerobic treadmill training improved quality of life. Aerobic treadmill training or outdoor-overground walking improved depression, endurance and mobility. Further studies are needed to clarify the effects of aerobic training on physical activity levels and time spent in low-energy expenditure activities after stroke.",2020,"Both groups improved depression (2.2 points;95% CI:0.01-4.3), endurance (Six-minute walk test:31 m;95% CI:5.6-57, Incremental shuttle-walk","['people with stroke', '22 adults with chronic stroke']","['aerobic treadmill training', 'GROUP', 'Aerobic treadmill training', 'aerobic training', 'Aerobic treadmill training or outdoor-overground walking']","['depression, endurance and mobility', 'cardiorespiratory fitness, endurance, depression, mobility, quality of life and participation (secondary outcomes) after stroke', 'quality of life', 'physical activity levels and time spent in low-energy expenditure activities', 'mobility', 'depression', 'physical activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",22.0,0.150659,"Both groups improved depression (2.2 points;95% CI:0.01-4.3), endurance (Six-minute walk test:31 m;95% CI:5.6-57, Incremental shuttle-walk","[{'ForeName': 'Larissa Tavares', 'Initials': 'LT', 'LastName': 'Aguiar', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Nadeau', 'Affiliation': ""École de Réadaptation, Université de Montréal (UdeM), and Centre de recherche interdisciplinaire en réadaptation (CRIR), Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM), CIUSSS Centre-sud-de-l'Ile-de-Montréal, Montréal, Canada.""}, {'ForeName': 'Raquel Rodrigues', 'Initials': 'RR', 'LastName': 'Britto', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Luci Fuscaldi', 'Initials': 'LF', 'LastName': 'Teixeira-Salmela', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Júlia Caetano', 'Initials': 'JC', 'LastName': 'Martins', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Giane Amorim Ribeiro', 'Initials': 'GAR', 'LastName': 'Samora', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'João Antônio', 'Initials': 'JA', 'LastName': 'da Silva Júnior', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Christina Danielli Coelho de Morais', 'Initials': 'CDCM', 'LastName': 'Faria', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}]",NeuroRehabilitation,['10.3233/NRE-193013']
733,32250337,Effects of EMG-triggered FES during trunk pattern in PNF on balance and gait performance in persons with stroke.,"BACKGROUND


EMG-triggered functional electrical stimulation (EMG-triggered FES) is one of the effective method for improving task performance and providing movement re-learning of central nervous system. Proprioceptive neuromuscular facilitation (PNF) is a traditional manual therapy that is used as a method to regain normal movement by providing specific training methods.
OBJECTIVE


The purpose of this study was to investigate the effect of EMG-triggered FES during trunk pattern in PNF on trunk control, balance, and gait of stroke patients.
METHODS


Forty participants were randomly allocated to EMG-triggered FES during PNF trunk pattern group (n = 20) and PNF trunk pattern group (n = 20). This study was a pretest-posttest with a control group design for duration of 4weeks (30 min/5 times/1 week). Outcome measures involved trunk impairment scale (TIS), Berg balance scale (BBS), and dynamic gait index (DGI).
RESULTS


In the experimental group and control group, TIS, BBS, and DGI score was significantly increased after intervention. However, there was no significant difference between the two groups in the comparison of the experimental group and the control group according to the amount of change before and after the training.
CONCLUSIONS


The results of this study showed that PNF trunk pattern affected the trunk control for stroke patients, and increased trunk control ability was effective in improving balance and walking. In addition, it was found that the EMG-triggered FES applied to the PNF trunk pattern affected the trunk control.",2020,"In the experimental group and control group, TIS, BBS, and DGI score was significantly increased after intervention.","['persons with stroke', 'Forty participants']","['EMG-triggered FES', 'Proprioceptive neuromuscular facilitation (PNF', 'EMG-triggered FES during PNF trunk pattern group (n\u200a=\u200a20) and PNF trunk pattern group', 'EMG-triggered functional electrical stimulation (EMG-triggered FES']","['trunk control ability', 'balance and gait performance', 'trunk impairment scale (TIS), Berg balance scale (BBS), and dynamic gait index (DGI', 'TIS, BBS, and DGI score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0426971', 'cui_str': 'Trunk control'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index'}, {'cui': 'C0475413', 'cui_str': 'Tis category'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0195031,"In the experimental group and control group, TIS, BBS, and DGI score was significantly increased after intervention.","[{'ForeName': 'Jaehong', 'Initials': 'J', 'LastName': 'Shim', 'Affiliation': 'Department of Physical Therapy, ROI Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sujin', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Department of Physical Therapy, Baekseok University, Chungcheongnam-do, Republic of Korea.'}, {'ForeName': 'Kyongil', 'Initials': 'K', 'LastName': 'Ki', 'Affiliation': 'Department of Physical Therapy, Walkrun Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Youngkeun', 'Initials': 'Y', 'LastName': 'Woo', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Jeonju, Republic of Korea.'}]",Restorative neurology and neuroscience,['10.3233/RNN-190944']
734,32109729,Low-cost self-paced interventions increase birth satisfaction in first time fathers.,"OBJECTIVE


This research aims to investigate whether a skills or birth stories intervention for fathers can improve birth satisfaction of fathers.
STUDY DESIGN


One hundred and seventy-four men were recruited and randomly assigned to a skills preparation group, a birth stories group, or a treatment as usual (TAU) group. One hundred sixteen men completed the three questionnaires relevant for this report (67% retention rate). Birth satisfaction was measured soon after birth.
MEASURES


Demographic data and data related to partners pregnancy, birth and preparation were collected. The Mackey Childbirth Satisfaction Rating Scale was the primary outcome measure.
RESULTS


It was found that men who received either of the birth preparation interventions (skills or birth stories booklet) had significantly higher birth satisfaction scores. An analysis found that, irrespective of intervention, his partner having an induction, a caesarean section, and his not being in full-time employment had a negative effect on birth satisfaction, while his partner having an epidural, his experiencing family life satisfaction before the birth, his finding antenatal classes useful, and having his birth delivery expectations met had a positive impact on birth satisfaction.
CONCLUSION


Increasing the father's understanding, role expectations, and preparation for his partner's childbirth, may be important for fathers birth satisfaction. Expectations around childbirth and expectations of himself might be better managed to improve satisfaction. This study found evidence that simple low-cost interventions can improve birth satisfaction for new fathers.",2020,"An analysis found that, irrespective of intervention, his partner having an induction, a caesarean section, and his not being in full-time employment had a negative effect on birth satisfaction, while his partner having an epidural, his experiencing family life satisfaction before the birth, his finding antenatal classes useful, and having his birth delivery expectations met had a positive impact on birth satisfaction.
","['One hundred sixteen men completed the three questionnaires relevant for this report (67% retention rate', 'One hundred and seventy-four men', 'first time fathers', 'fathers', 'new fathers']","['skills preparation group, a birth stories group, or a treatment as usual (TAU', 'Low-cost self-paced interventions', 'birth stories intervention']","['birth satisfaction scores', 'Birth satisfaction', 'Mackey Childbirth Satisfaction Rating Scale', 'birth satisfaction']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0222045'}]",174.0,0.0625908,"An analysis found that, irrespective of intervention, his partner having an induction, a caesarean section, and his not being in full-time employment had a negative effect on birth satisfaction, while his partner having an epidural, his experiencing family life satisfaction before the birth, his finding antenatal classes useful, and having his birth delivery expectations met had a positive impact on birth satisfaction.
","[{'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Howarth', 'Affiliation': 'Dunedin School of Medicine, Department of Psychological Medicine, Dunedin, New Zealand.'}, {'ForeName': 'Nicola R', 'Initials': 'NR', 'LastName': 'Swain', 'Affiliation': 'Dunedin School of Medicine, Department of Psychological Medicine, Dunedin, New Zealand. Electronic address: nicola.swain@otago.ac.nz.'}]",Sexual & reproductive healthcare : official journal of the Swedish Association of Midwives,['10.1016/j.srhc.2020.100503']
735,32143552,Double-Blinded Prospective Randomized Clinical Trial Comparing Regular and Moses Modes of Holmium Laser Lithotripsy.,"Objective:  To compare regular and Moses modes of holmium laser lithotripsy during ureteroscopy in terms of fragmentation/pulverization and procedural times in addition to perioperative complications.  Patients and Methods:  After obtaining ethics approval, a prospective double-blinded randomized trial was conducted for patients undergoing holmium laser lithotripsy during retrograde ureteroscopy. Patients were randomly assigned to either regular or Moses modes. Patients and surgeons were blinded to the laser mode. Lumenis 120W generator with 200 Moses D/F/L fibers were used. Demographic data, stone parameters, perioperative complications, and success rates were compared. The degree of stone retropulsion was graded on a Likert scale from 0-no retropulsion to 3-maximum retropulsion.  Results:  A total of 72 patients were included in the study (36 per arm). Both groups were comparable in terms of age and preoperative stone size (1.4 cm  vs  1.7 cm,  p  > 0.05). When compared with the regular mode, Moses mode was associated with significantly lower fragmentation/pulverization time (21.1 minutes  vs  14.2 minutes;  p  = 0.03) and procedural time (50.9 minutes  vs  41.1 minutes,  p  = 0.03). However, there were no significant differences in terms of lasing time (7.4 minutes  vs  6.1 minutes,  p  > 0.05) and total energy applied to the stones (11.1 kJ  vs  10.8 kJ,  p  > 0.05). Moses mode was associated with significantly less retropulsion (mean grade was 1.0  vs  0.5,  p  = 0.01). There were no significant differences between both modes in terms of intraoperative complications (11.1%  vs  8.3%,  p  > 0.05), with one patient requiring endoureterotomy for stricture in the Moses group. Success rate at the end of 3 months was comparable between both groups (83.3%  vs  88.4%,  p  > 0.05).  Conclusion:  Moses technology was associated with significantly lower fragmentation/pulverization and procedural times. The reduced fragmentation/pulverization time seen using Moses technology could be explained by the significantly lower retropulsion of stones during laser lithotripsy.",2020,"Moses mode was associated with significantly less retropulsion (mean grade was 1.0 vs. 0.5, p=0.01).","['patients undergoing', 'A total of 72 patients were included in the study (36 per each arm']","['holmium laser lithotripsy during retrograde ureteroscopy', 'Holmium Laser Lithotripsy', 'holmium laser lithotripsy']","['lasing time', 'degree of stone retropulsion', 'Success rate', 'procedural time', 'fragmentation/pulverization time', 'intra-operative complications', 'Demographic data, stone parameters, peri-operative complications and success rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0277845', 'cui_str': 'Retropulsion (finding)'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation (morphologic abnormality)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",72.0,0.0732771,"Moses mode was associated with significantly less retropulsion (mean grade was 1.0 vs. 0.5, p=0.01).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Division of Urology, Department of Surgery, McGill University, Montreal, Canada.'}, {'ForeName': 'Mostafa M', 'Initials': 'MM', 'LastName': 'Elhilali', 'Affiliation': 'Division of Urology, Department of Surgery, McGill University, Montreal, Canada.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Fahmy', 'Affiliation': 'Division of Urology, Department of Surgery, McGill University, Montreal, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Carrier', 'Affiliation': 'Division of Urology, Department of Surgery, McGill University, Montreal, Canada.'}, {'ForeName': 'Sero', 'Initials': 'S', 'LastName': 'Andonian', 'Affiliation': 'Division of Urology, Department of Surgery, McGill University, Montreal, Canada.'}]",Journal of endourology,['10.1089/end.2019.0695']
736,22374991,"Gastric cancer incidence among Hispanics in California: patterns by time, nativity, and neighborhood characteristics.","BACKGROUND


Better understanding about gastric cancer incidence patterns among Hispanics by birthplace, socioeconomic status (SES), and acculturation can improve preventive strategies and disease models.
METHODS


Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer were calculated by age, sex, and nativity among Hispanics using California Cancer Registry data from 1988 through 2004. Incidence rates in 1998 to 2002 were compared by neighborhood SES and Hispanic enclave status according to 2000 US Census data.
RESULTS


Incidence rates of diffuse gastric cancer increased from 1988 through 2004 among foreign-born Hispanic men (EAPC: 3.5%, 95% CI: 1.5%-5.5%) and U.S.-born Hispanic women (EAPC: 3.0%, 95% CI: 0.7%-5.3%). During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women. Noncardia and both intestinal and diffuse gastric cancer were more common in foreign-born than U.S.-born Hispanic men and women, and in those from lower SES, higher enclave neighborhoods. By contrast, among younger and middle-aged Hispanic men, cardia tumors were more common in the U.S.-born than the foreign-born, and in higher SES, lower enclave neighborhoods.
CONCLUSIONS


Varying gastric cancer risk factors among Hispanic subgroups and increasing rates of diffuse gastric cancer in foreign-born Hispanic men and U.S.-born Hispanic women merit further investigation to identify separate disease etiologies.
IMPACT


Age, sex, birthplace, SES, and acculturation modify gastric cancer incidence in Hispanics and should be considered when examining disease risk and prevention.",2012,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","['foreign-born Hispanic men and U.S.-born Hispanic women', 'younger and middle-aged Hispanic men, cardia tumors', 'Hispanics in California']",[],"['Noncardia and both intestinal and diffuse gastric cancer', 'Incidence rates', 'time, nativity, and neighborhood characteristics', 'cardia and noncardia gastric cancer', 'Incidence rates of diffuse gastric cancer', 'Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer', 'Gastric cancer incidence', 'incidence rates of intestinal gastric cancer']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0006754', 'cui_str': 'California'}]",[],"[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.019428,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","[{'ForeName': 'Ellen T', 'Initials': 'ET', 'LastName': 'Chang', 'Affiliation': 'Cancer Prevention Institute of California, Fremont, CA, USA. echang@exponent.com'}, {'ForeName': 'Scarlett Lin', 'Initials': 'SL', 'LastName': 'Gomez', 'Affiliation': ''}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Fish', 'Affiliation': ''}, {'ForeName': 'Clayton W', 'Initials': 'CW', 'LastName': 'Schupp', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Parsonnet', 'Affiliation': ''}, {'ForeName': 'Mindy C', 'Initials': 'MC', 'LastName': 'DeRouen', 'Affiliation': ''}, {'ForeName': 'Theresa H M', 'Initials': 'TH', 'LastName': 'Keegan', 'Affiliation': ''}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Clarke', 'Affiliation': ''}, {'ForeName': 'Sally L', 'Initials': 'SL', 'LastName': 'Glaser', 'Affiliation': ''}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-11-1208']
737,32145441,A randomized trial of a multi-level intervention to improve advance care planning and symptom management among low-income and minority employees diagnosed with cancer in outpatient community settings.,"INTRODUCTION


Equitable delivery of advance care planning and symptom management among patients is crucial to improving cancer care. Existing interventions to improve the uptake of these services have predominantly occurred in clinic settings and are limited in their effectiveness, particularly among low-income and minority populations.
METHODS


The ""Lay health worker Educates Engages and Activates Patients to Share (LEAPS)"" intervention was developed to improve advance care planning and symptom management among low-income and minority hourly-wage workers with cancer, in two community settings. The intervention provides a lay health worker to all patients newly diagnosed with cancer and aims to educate and activate patients to engage in advance care planning and symptom management with their oncology providers. In this randomized clinical trial, we will evaluate the effect on quality of life (primary outcome) using the validated Functional Assessment of Cancer Therapy - General Survey, at enrollment, 4- and 12- months post-enrollment. We will examine between-group differences on our secondary outcomes of patient activation, patient satisfaction with healthcare decision-making, and symptom burden (at enrollment, 4- and 12-months post-enrollment), and total healthcare use and healthcare costs (at 12-months post-enrollment).
DISCUSSION


Multilevel approaches are urgently needed to improve cancer care delivery among low-income and minority patients diagnosed with cancer in community settings. The current study describes the LEAPS intervention, the study design, and baseline characteristics of the community centers participating in the study. ClinicalTrials.gov Registration #NCT03699748.",2020,"METHODS


The ""Lay health worker Educates Engages and Activates Patients to Share (LEAPS)"" intervention was developed to improve advance care planning and symptom management among low-income and minority hourly-wage workers with cancer, in two community settings.","['community centers participating in the study', 'minority patients diagnosed with cancer in community settings', 'low-income and minority employees diagnosed with cancer in outpatient community settings', 'and minority hourly-wage workers with cancer, in two community settings', 'The ""Lay health worker Educates Engages and Activates Patients to', 'patients newly diagnosed with cancer']","['advance care planning and symptom management among low-income', 'LEAPS intervention', 'Share (LEAPS)"" intervention', 'multi-level intervention']","['quality of life', 'total healthcare use and healthcare costs', 'patient activation, patient satisfaction with healthcare decision-making, and symptom burden']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0036064', 'cui_str': 'Wages'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]","[{'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",2.0,0.104465,"METHODS


The ""Lay health worker Educates Engages and Activates Patients to Share (LEAPS)"" intervention was developed to improve advance care planning and symptom management among low-income and minority hourly-wage workers with cancer, in two community settings.","[{'ForeName': 'Manali I', 'Initials': 'MI', 'LastName': 'Patel', 'Affiliation': 'Division of Oncology, Stanford University School of Medicine, Stanford, CA, United States of America; Medical Services, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, United States of America; Center for Primary Care and Outcomes Research/Health Research and Policy, Stanford University School of Medicine, Stanford, CA, United States of America. Electronic address: manalip@stanford.edu.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Khateeb', 'Affiliation': 'Division of Oncology, Stanford University School of Medicine, Stanford, CA, United States of America.'}, {'ForeName': 'Tumaini', 'Initials': 'T', 'LastName': 'Coker', 'Affiliation': ""Seattle Children's Research Institute, Seattle, WA, United States of America; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.105971']
738,32246762,Effect of adjunctive vaginal progesterone after McDonald cerclage on the rate of second-trimester abortion in singleton pregnancy: a randomized controlled trial.,"OBJECTIVE


To evaluate the effect of adjunctive use of vaginal progesterone after McDonald cerclage on the rate of second-trimester abortion in singleton pregnancy.
METHODS


A randomized controlled trial at Woman's Health Hospital, Assiut University, Egypt, between April 2017 and March 2019 enrolled women eligible for McDonald cerclage. After cerclage, participants were randomly assigned to receive progesterone (400 mg pessary) once daily until 37 weeks or no progesterone. The primary outcome was rate of abortion before 28 weeks. Secondary outcomes included gestational age at delivery, preterm delivery, mean birthweight, Apgar score, and admission to the neonatal intensive care unit (NICU).
RESULTS


The rate of spontaneous abortion was higher in the no-progesterone group (P=0.016). Mean gestational age and mean birthweight was higher in the progesterone group (P<0.001 and P=0.002, respectively). The frequency of preterm neonates, neonates with Apgar score less than 7, and admission to NICU was higher in the progesterone group than in the no-progesterone group (P=0.005, P=0.008, and P=0.044, respectively).
CONCLUSION


Adjunctive use of vaginal progesterone after McDonald cerclage was found to decrease the frequency of second-trimester abortion and to improve perinatal outcomes in singleton pregnancy. Clinicaltrials.gov: NCT02846909.",2020,"birthweight was higher in the progesterone group (P<0.001 and P=0.002, respectively).","['Mean gestational age and mean', 'singleton pregnancy', ""Woman's Health Hospital, Assiut University, Egypt, between April 2017 and March 2019 enrolled women eligible for McDonald cerclage""]","['adjunctive vaginal progesterone', 'progesterone (400\xa0mg pessary) once daily until 37\xa0weeks or no progesterone', 'vaginal progesterone']","['frequency of preterm neonates, neonates with Apgar score', 'rate of abortion', 'admission to NICU', 'gestational age at delivery, preterm delivery, mean birthweight, Apgar score, and admission to the neonatal intensive care unit (NICU', 'rate of second-trimester abortion', 'rate of spontaneous abortion', 'perinatal outcomes', 'frequency of second-trimester abortion', 'birthweight']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1292825', 'cui_str': 'Cerclage'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0032980', 'cui_str': 'Second trimester pregnancy'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}]",,0.209308,"birthweight was higher in the progesterone group (P<0.001 and P=0.002, respectively).","[{'ForeName': 'Mohammed K', 'Initials': 'MK', 'LastName': 'Ali', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Sameh E', 'Initials': 'SE', 'LastName': 'Ahmed', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Gamal H', 'Initials': 'GH', 'LastName': 'Sayed', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Esraa Y', 'Initials': 'EY', 'LastName': 'Badran', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abbas', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13148']
739,32187403,Carbohydrates do not accelerate force recovery after glycogen-depleting followed by high-intensity exercise in humans.,"Prolonged low-frequency force depression (PLFFD) induced by fatiguing exercise is characterized by a persistent depression in submaximal contractile force during the recovery period. Muscle glycogen depletion is known to limit physical performance during prolonged low- and moderate-intensity exercise, and accelerating glycogen resynthesis with post-exercise carbohydrate intake can facilitate recovery and improve repeated bout exercise performance. Short-term, high-intensity exercise, however, can cause PLFFD without any marked decrease in glycogen. Here, we studied whether recovery from PLFFD was accelerated by carbohydrate ingestion after 60 minutes of moderate-intensity glycogen-depleting cycling exercise followed by six 30-seconds all-out cycling sprints. We used a randomized crossover study design where nine recreationally active males drank a beverage containing either carbohydrate or placebo after exercise. Blood glucose and muscle glycogen concentrations were determined at baseline, immediately post-exercise, and during the 3-hours recovery period. Transcutaneous electrical stimulation of the quadriceps muscle was performed to determine the extent of PLFFD by eliciting low-frequency (20 Hz) and high-frequency (100 Hz) stimulations. Muscle glycogen was severely depleted after exercise, with a significantly higher rate of muscle glycogen resynthesis during the 3-hours recovery period in the carbohydrate than in the placebo trials (13.7 and 5.4 mmol glucosyl units/kg wet weight/h, respectively). Torque at 20 Hz was significantly more depressed than 100 Hz torque during the recovery period in both conditions, and the extent of PLFFD (20/100 Hz ratio) was not different between the two trials. In conclusion, carbohydrate supplementation enhances glycogen resynthesis after glycogen-depleting exercise but does not improve force recovery when the exercise also involves all-out cycling sprints.",2020,"Torque at 20Hz was significantly more depressed than 100 Hz torque during the recovery period in both conditions, and the extent of PLFFD (20/100Hz ratio) was not different between the two trials.",['nine recreationally-active males drank a beverage containing either'],"['carbohydrate or placebo', 'placebo', 'carbohydrate supplementation']","['Torque at 20Hz', 'PLFFD by eliciting low-frequency (20Hz) and high-frequency (100Hz) stimulations', 'glycogen', 'Blood glucose and muscle glycogen concentrations', 'Muscle glycogen', 'rate of muscle glycogen re-synthesis']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3538953', 'cui_str': 'Carbohydrate supplementation'}]","[{'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.125912,"Torque at 20Hz was significantly more depressed than 100 Hz torque during the recovery period in both conditions, and the extent of PLFFD (20/100Hz ratio) was not different between the two trials.","[{'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'Cheng', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chaillou', 'Affiliation': 'School of Health Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Sigitas', 'Initials': 'S', 'LastName': 'Kamandulis', 'Affiliation': 'Sports Science and Innovation Institute, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Andrejus', 'Initials': 'A', 'LastName': 'Subocius', 'Affiliation': 'Sports Science and Innovation Institute, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Westerblad', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Brazaitis', 'Affiliation': 'Sports Science and Innovation Institute, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Venckunas', 'Affiliation': 'Sports Science and Innovation Institute, Lithuanian Sports University, Kaunas, Lithuania.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13655']
740,32114185,Augmenting usual care SSRIs with cognitive behavioral therapy for insomnia to improve depression outcomes in youth: Design of a randomized controlled efficacy-effectiveness trial.,"IMPORTANCE


Extant treatments for youth depression are only modestly effective. Alternative approaches are needed to improve health outcomes. A novel approach to improve depression outcomes is suggested by epidemiological studies finding that insomnia often predates and may contribute to depression risk. We test whether treating insomnia among youth starting a new course of SSRI antidepressants improves depression outcomes. This paper describes our study design.
DESIGN


2-arm randomized controlled efficacy-effectiveness trial.
SETTING


A large non-profit health maintenance organization.
PARTICIPANTS


165 adolescents aged 12-19 with research-confirmed depression and insomnia diagnoses, starting a new episode of selective serotonin reuptake inhibitor (SSRI) antidepressant treatment prescribed by their usual care provider.
INTERVENTIONS


Two sleep interventions, each 6-7 sessions, both overlaying ""treatment as usual"" (TAU) SSRIs: a sleep hygiene (SH) attention control condition, and cognitive-behavioral therapy for insomnia (CBTI).
CONCLUSIONS AND RELEVANCE


If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.
TRIAL REGISTRATION


clinicaltrials.gov, NCT02290496, https://clinicaltrials.gov/ct2/show/NCT02290496.",2020,"If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.
","['youth', 'A large non-profit health maintenance organization', '165 adolescents aged 12-19 with research-confirmed depression and insomnia diagnoses, starting a new episode of selective serotonin reuptake inhibitor (SSRI) antidepressant treatment prescribed by their usual care provider']","['cognitive behavioral therapy', 'overlaying ""treatment as usual"" (TAU) SSRIs: a sleep hygiene (SH) attention control condition, and cognitive-behavioral therapy for insomnia (CBTI', 'SSRI antidepressants']",['depression outcomes'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018720', 'cui_str': 'Prepaid Group Health Organizations'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035168'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0565959', 'cui_str': 'New episode (qualifier value)'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0444456', 'cui_str': 'Overlay (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",165.0,0.0962211,"If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.
","[{'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Clarke', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Greg.Clarke@kpchr.org.'}, {'ForeName': 'Christina R', 'Initials': 'CR', 'LastName': 'Sheppler', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Christina.R.Sheppler@kpchr.org.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Firemark', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Alison.J.Firemark@kpchr.org.'}, {'ForeName': 'Andreea M', 'Initials': 'AM', 'LastName': 'Rawlings', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Andreea.M.Rawlings@kpchr.org.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dickerson', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: John.F.Dickerson@kpchr.org.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Michael.C.Leo@kpchr.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105967']
741,32114186,Feasibility and preliminary effects of a peer-led motivationally-embellished workplace walking intervention: A pilot cluster randomized trial (the START trial).,"Walking interventions can be effective in increasing physical activity amongst physically inactive employees. However, despite their promising potential regarding sustainability and scalability, peer-led workplace walking interventions have not been tested. We evaluated a peer-led workplace group walking intervention designed to engage physically inactive employees. A 16-week pilot cluster randomized controlled trial consisted of enhanced (5 worksites; n = 50 participants) and minimal treatment (3 worksites; n = 47) conditions. All participants were provided with a Fitbit Zip and information on health benefits of walking. Enhanced treatment participants had access to a mobile phone app incorporating behavior change techniques, were trained on principles of autonomous motivation, and had a peer leader trained in a motivationally supportive communication style. Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only). Outcomes assessed included movement-related behaviors (assessed via activPAL devices), cardio-metabolic risk factors, motivation to walk, and well-being, and these measures were taken at baseline and post-intervention. The results supported intervention feasibility. Preliminary efficacy evidence was mixed. Markers of cardio-metabolic risk improved in the enhanced treatment only. Autonomous motivation increased in both conditions. There were no changes in step counts, standing, and sitting time, or well-being. Further fine tuning is needed before a definitive RCT. Australian and New Zealand Clinical Trials Registry: ACTRN12618000807257.",2020,"Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only).",['Australian and New Zealand'],"['enhanced (5 worksites; n\u202f=\u202f50 participants) and minimal treatment (3 worksites; n\u202f=\u202f47) conditions', 'peer-led workplace group walking intervention', 'peer-led motivationally-embellished workplace walking intervention', 'Walking interventions']","['step counts, standing, and sitting time, or well-being', 'Markers of cardio-metabolic risk', 'Autonomous motivation', 'movement-related behaviors (assessed via activPAL devices), cardio-metabolic risk factors, motivation to walk, and well-being, and these measures', 'Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0043016', 'cui_str': 'Walkers'}]",50.0,0.113263,"Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thøgersen-Ntoumani', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia. Electronic address: c.thogersen@curtin.edu.au.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Quested', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Smith', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nicholas', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McVeigh', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, Australia.'}, {'ForeName': 'S A M', 'Initials': 'SAM', 'LastName': 'Fenton', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, England.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stamatakis', 'Affiliation': 'Charles Perkins Centre, School of Public Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': 'Centre for Transformative Work Design, Future of Work Institute, Curtin University, Perth, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pereira', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Gucciardi', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105969']
742,32119926,A comparative effectiveness trial of an information technology enhanced peer-integrated collaborative care intervention versus enhanced usual care for US trauma care systems: Clinical study protocol.,"Annually approximately 2-3 million Americans are so severely injured that they require inpatient hospitalization. The study team, which includes patients, clinical researchers, front-line provider and policy maker stakeholders, has been working together for over a decade to develop interventions that target improvements for US trauma care systems nationally. This pragmatic randomized trial compares a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists, versus trauma team notification of patient emotional distress with mental health consultation as enhanced usual care. The peer-integrated collaborative care intervention will be supported by a novel emergency department exchange health information technology platform. A total of 424 patients will be randomized to peer-integrated collaborative care (n = 212) and surgical team notification (n = 212) conditions. The study hypothesizes that patient's randomized to peer integrated collaborative care intervention will demonstrate significant reductions in emergency department health service utilization, severity of patient concerns, post traumatic stress disorder symptoms, and physical limitations when compared to surgical team notification. These four primary outcomes will be followed-up at 1- 3-, 6-, 9- and 12-months after injury for all patients. The Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) method will be used to assess implementation processes. Data from the primary outcome analysis and implementation process assessment will be used to inform an end-of-study policy summit with the American College of Surgeons Committee on Trauma. The policy summit will facilitate acute care practice changes related to patient-centered care transitions over the course of a single 5-year funding cycle. Trial registration: (Clinicaltrials.govNCT03569878).",2020,"The study hypothesizes that patient's randomized to peer integrated collaborative care intervention will demonstrate significant reductions in emergency department health service utilization, severity of patient concerns, post traumatic stress disorder symptoms, and physical limitations when compared to surgical team notification.","['424 patients will be randomized to peer-integrated collaborative care (n\u202f=\u202f212) and surgical team notification (n\u202f=\u202f212) conditions', 'integrates front-line trauma center staff with peer interventionists, versus trauma team notification of patient emotional distress with mental health consultation as enhanced usual care']","['information technology enhanced peer-integrated collaborative care intervention', 'peer integrated collaborative care intervention']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0683867', 'cui_str': 'Information Technology'}]",[],424.0,0.135098,"The study hypothesizes that patient's randomized to peer integrated collaborative care intervention will demonstrate significant reductions in emergency department health service utilization, severity of patient concerns, post traumatic stress disorder symptoms, and physical limitations when compared to surgical team notification.","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Scheuer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: hscheuer@uw.edu.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Engstrom', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: alliengs@uw.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': 'Powers Pyles Sutter & Verville PC, 501 M Street, NW, Seventh Floor, Washington, DC 20005, United States of America. Electronic address: Peter.Thomas@PowersLaw.com.'}, {'ForeName': 'Rddhi', 'Initials': 'R', 'LastName': 'Moodliar', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: rddhim@uw.edu.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Moloney', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: kmoloney@uw.edu.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Walen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: marylouw@uw.edu.'}, {'ForeName': 'Peyton', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: peej23@uw.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Seo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: saraseo@uw.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Vaziri', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: nvaziri@uw.edu.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: alvmarti@uw.edu.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Maier', 'Affiliation': 'Department of Surgery, University of Washington School of Medicine, 410 9th Ave., Seattle, WA 98104, United States of America. Electronic address: ronmaier@uw.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Russo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: jerusso@uw.edu.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Sieber', 'Affiliation': 'Molecular Genomics Core/Microarray Group, National Institute of Environmental Health Sciences, P.O. Box 12233, Mail Drop D2-04, Durham, N.C 27709, United States of America. Electronic address: sieber@niehs.nih.gov.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Anziano', 'Affiliation': 'Shepherd Center, 2020 Peachtree Road NW, Atlanta, GA 30309-1465, United States of America. Electronic address: Pete.Anziano@shepherd.org.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America; The Koshka Foundation, United States of America. Electronic address: kanderson@koshkafoundation.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bulger', 'Affiliation': 'Department of Surgery, University of Washington School of Medicine, 410 9th Ave., Seattle, WA 98104, United States of America. Electronic address: ebulger@uw.edu.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Whiteside', 'Affiliation': 'Department of Emergency Medicine, University of Washington School of Medicine, 325 9th Ave., Seattle, WA 98104, United States of America. Electronic address: laurenkw@uw.edu.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington School of Public Health, 1705 NE Pacific St., Seattle, WA 98195, United States of America. Electronic address: heagerty@uw.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Palinkas', 'Affiliation': 'Department of Children, Youth and Families, USC Suzanne Dworak-Peck School of Social Work, 669 W 34(th) St., Los Angeles, CA 90089, United States of America. Electronic address: palinkas@usc.edu.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Zatzick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: dzatzick@uw.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105970']
743,32145440,Rationale and design of the granulocyte-macrophage colony stimulating factor in peripheral arterial disease (GPAD-3) study.,"BACKGROUND


Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials. The GPAD-3 trial will study the effect of two successive administrations of GM-CSF at 3-month interval for improving claudication among patients with lower extremity PAD.
METHODS


We plan to recruit 176 patients in this ongoing randomized, double-blind, placebo-controlled Phase IIB trial. After screening for inclusion and exclusion criteria, eligible subjects undergo a 4-week screening phase where they perform subcutaneous placebo injections thrice weekly and walk at least three times a day until they develop claudication. After the screening phase, eligible subjects undergo baseline testing and are randomized 2:1 to receive 500 μg/day of GM-CSF subcutaneously thrice weekly for three weeks or placebo injections. After 3 months, follow-up endpoint testing is performed and subjects in the GM-CSF group receive the second administration of the drug for three weeks while subjects in placebo group receive matching placebo injections. All participants undergo endpoint testing at six-month and nine-month follow-up. The primary endpoint is change in 6-min walk distance between baseline and 6-month follow-up.
CONCLUSION


GPAD-3 explores a novel approach to address the need for alternative therapies that can alleviate symptoms among patients with lower extremity PAD. If successful, this study will pave the way for a pivotal Phase III trial.",2020,Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials.,"['176 patients', 'patients with PAD experience claudication despite adequate medical and/or surgical management', 'patients with lower extremity PAD']","['GM-CSF', 'placebo', 'Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF', 'granulocyte-macrophage colony stimulating factor', 'placebo group receive matching placebo injections', 'placebo injections']",['change in 6-min walk distance between baseline and 6-month follow-up'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.40022,Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials.,"[{'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Mehta', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Rogers', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Devinder S', 'Initials': 'DS', 'LastName': 'Dhindsa', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Cydney', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Risha', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Mohammad A', 'Initials': 'MA', 'LastName': 'Martini', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Mahadev', 'Initials': 'M', 'LastName': 'Prasad', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mokhtari', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Iraj G', 'Initials': 'IG', 'LastName': 'Hesaroieh', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Frohwein', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Kutner', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Harzand', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Wells', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Yazan', 'Initials': 'Y', 'LastName': 'Duwayri', 'Affiliation': 'Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Olamide', 'Initials': 'O', 'LastName': 'Alabi', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia; Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ravi R', 'Initials': 'RR', 'LastName': 'Rajani', 'Affiliation': 'Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Luke P', 'Initials': 'LP', 'LastName': 'Brewster', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia; Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': 'Winship Cancer Institute, Department of Hematology and Oncology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Arshed A', 'Initials': 'AA', 'LastName': 'Quyyumi', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia. Electronic address: Aquyyum@Emory.Edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105975']
744,32087336,Pragmatic trial design of an intervention to reduce cardiovascular risk in people with serious mental illness.,"BACKGROUND


Cardiovascular (CV) disease is the leading cause of death for people with serious mental illness (SMI), but clinicians are often slow to address this risk.
METHODS/DESIGN


78 Midwestern primary care clinics were randomized to receive or not receive access to a clinical decision support (CDS) tool. Between March 2016 and September 2018, primary care clinicians (PCPs) received CDS alerts during visits with adult patients with SMI who met minimal inclusion criteria and had at least one CV risk factor not at goal. The PCP CDS included a summary of six modifiable CV risk factors and patient-specific treatment recommendations. Psychiatrists received CDS alerts during their next visit with an eligible patient with SMI that alerted them to an elevated body mass index or recent weight gain and the presence of an obesogenic SMI medication. Study outcomes include total modifiable CV risk, six modifiable CV risk factors, and use of obesogenic SMI medications.
DISCUSSION


This cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI. Effectiveness will be assessed using an intent-to-treat analysis, and outcomes will be assessed largely through electronic health record data harvested by the CDS tool itself. In total, 10,347 patients with SMI had an index primary care visit in a randomized clinic, and 8937 patients had at least one follow-up visit. Analyses are ongoing, and trial results are expected in mid-2020.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02451670.",2020,This cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI.,"['patients with SMI', '10,347 patients with SMI had an index primary care visit in a randomized clinic, and 8937 patients had at least one follow-up visit', 'Between March 2016 and September 2018, primary care clinicians (PCPs) received CDS alerts during visits with adult patients with SMI who met minimal inclusion criteria and had at least one CV risk factor not at goal', 'people with serious mental illness', 'people with serious mental illness (SMI', '78 Midwestern primary care clinics']",['clinical decision support (CDS) tool'],"['CV risk', 'total modifiable CV risk, six modifiable CV risk factors, and use of obesogenic SMI medications', 'cardiovascular risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C4042765', 'cui_str': 'Clinical Decision Support'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",10347.0,0.266181,This cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI.,"[{'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Rossom', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America. Electronic address: rebecca.c.rossom@healthpartners.com.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}, {'ForeName': 'A Lauren', 'Initials': 'AL', 'LastName': 'Crain', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Waring', 'Affiliation': 'Essentia Health, Duluth, MN, United States of America.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Ohnsorg', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}, {'ForeName': 'Allise', 'Initials': 'A', 'LastName': 'Taran', 'Affiliation': 'Essentia Health, Duluth, MN, United States of America.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Kopski', 'Affiliation': 'HealthPartners Medical Group, Minneapolis, MN, United States of America.'}, {'ForeName': 'JoAnn M', 'Initials': 'JM', 'LastName': 'Sperl-Hillen', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105964']
745,32087338,The impact of financial incentives on utilization and outcomes of diabetes prevention programs among Medicaid managed care adults in New York state.,"Diabetes prevalence has risen rapidly and has become a global health challenge. The Diabetes Prevention Program (DPP) has been shown to prevent or delay the development of diabetes among individuals with prediabetes. Yet, diabetes prevention studies within the Medicaid population are limited and results are mixed. This study aimed to evaluate the impact of different financial incentive strategies on the utilization of the DPP for Medicaid managed care adults in New York State. A four-arm randomized controlled trial was conducted among Medicaid managed care adult enrollees diagnosed with prediabetes and/or obesity. Study participants were offered a 16-week DPP with various incentive strategies based on class attendance and weight loss as follows: Attendance-Only, Weight-Loss Only, and both Attendance and Weight-Loss. A control group was offered DPP with no incentives for attendance or weight loss. We evaluated the impact of incentives on achievement of the program completion and weight-loss milestone. Participants who received incentives for the Attendance-Only class were least likely to be lost to follow-up, more likely to complete the program, and had two times higher percentage of meeting the weight-loss milestone compared to the control group. Results for the other incentive cohorts were mixed. A strong positive association was observed for participants who attended 9 or more classes and weight-loss regardless of incentive strategies. Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone. However, the results from this study indicate that participant enrollment and retention remained challenges despite the incentives.",2020,Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone.,"['Medicaid managed care adult enrollees diagnosed with prediabetes and/or obesity', 'individuals with prediabetes', 'Medicaid managed care adults in New York State', 'Medicaid managed care adults in New York state']","['Diabetes Prevention Program (DPP', 'DPP with various incentive strategies based on class attendance and weight loss as follows']","['weight-loss milestone', 'Attendance-Only, Weight-Loss Only, and both Attendance and Weight-Loss']","[{'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0283401,Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone.,"[{'ForeName': 'Jo-Yu', 'Initials': 'JY', 'LastName': 'Chin', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: Jo-Yu.Chin@health.ny.gov.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Matson', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: jacqueline.matson@health.ny.gov.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McCauley', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: susan.mccauley@health.ny.gov.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Anarella', 'Affiliation': 'Albany, NY, USA. Electronic address: joeanarella@gmail.com.'}, {'ForeName': 'Foster', 'Initials': 'F', 'LastName': 'Gesten', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: fgesten@nycap.rr.com.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Roohan', 'Affiliation': 'MVP Health Care, Schenectady, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105960']
746,32151753,Design of a home-based intervention for Houston-area African-American adults with asthma: Methods and lessons learned from a pragmatic randomized trial.,"A growing body of evidence demonstrates that home-based, multicomponent interventions can effectively reduce exposures to asthma triggers and decrease asthma symptoms. However, few of these studies have targeted adults. To address this and other research gaps, we designed and implemented a pragmatic randomized clinical trial, the Houston Home-based Integrated Intervention Targeting Better Asthma Control (HIITBAC) for African Americans, to assess the effectiveness of a home-based intervention to improve asthma control and quality of life in African-American adults-a population disproportionately affected by asthma. The primary goals were to help participants reduce allergens and irritants in their homes and better manage their disease through knowledge, improved medication use, and behavior change. HIITBAC had two groups: clinic-only and home-visit groups. Both groups received enhanced clinical care, but the home-visit group also received a detailed home assessment and four additional home visits spaced over roughly one year. We recruited 263 participants. Of these, 152 (57.8%) were recruited through electronic health record data, 51 (19.4%) through Emergency Medical Services data, and 60 (22.8%) through other efforts (e.g., emergency departments, community events, outreach). Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group. We describe the HIITBAC methodology and cohort, discuss lessons learned about recruitment and retention, and highlight adaptations we implemented to address these lessons.",2020,"Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group.","['152 (57.8%) were recruited through electronic health record data, 51 (19.4%) through Emergency Medical Services data, and 60 (22.8%) through other efforts (e.g., emergency departments, community events, outreach', 'African-American adults-a population disproportionately affected by asthma', 'HIITBAC had two groups: clinic-only and home-visit groups', 'Houston-area African-American adults with asthma', '263 participants', 'Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group', 'African Americans']","['home-based intervention', 'Houston Home-based Integrated Intervention Targeting Better Asthma Control (HIITBAC']","['allergens and irritants in their homes and better manage their disease through knowledge, improved medication use, and behavior change', 'asthma control and quality of life']","[{'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C4709305', 'cui_str': '19.4 (qualifier value)'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0348027', 'cui_str': 'Irritant (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034380'}]",263.0,0.076198,"Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group.","[{'ForeName': 'Rebecca Jensen', 'Initials': 'RJ', 'LastName': 'Bruhl', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States. Electronic address: Rebecca.J.Bruhl@bcm.edu.'}, {'ForeName': 'William Brett', 'Initials': 'WB', 'LastName': 'Perkison', 'Affiliation': 'Department of Epidemiology, Human Genetics and Environmental Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Houston, TX, United States.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Lorna H', 'Initials': 'LH', 'LastName': 'McNeill', 'Affiliation': 'Department of Health Disparities Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Abiodun O', 'Initials': 'AO', 'LastName': 'Oluyomi', 'Affiliation': 'Section of Epidemiology and Population Science, Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Ellen Baskin', 'Initials': 'EB', 'LastName': 'Fiesinger', 'Affiliation': 'Department of Management, Policy and Community Health, The University of Texas Health Science Center at Houston, School of Public Health, Houston, TX, United States.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Minard', 'Affiliation': 'Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Abida', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'College of Nursing, Prairie View A&M University, Houston, TX, United States.'}, {'ForeName': 'Winifred J', 'Initials': 'WJ', 'LastName': 'Hamilton', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Butler', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Caldwell', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Crosby', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Cellie', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Galvan', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': ""Frene'"", 'Initials': 'F', 'LastName': 'Lacour-Chestnut', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Shereda', 'Initials': 'S', 'LastName': 'Pannell', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Phipps', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Gwendolyn', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Adriene', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'White', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Boles', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Rangel', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Ritupreet', 'Initials': 'R', 'LastName': 'Virk', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Brock', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Guffey', 'Affiliation': 'Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Ramamurthy', 'Affiliation': 'Office of Research Information Technology, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Persse', 'Affiliation': 'Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, United States; Emergency Medical Services, Houston Fire Department, City of Houston, TX, United States.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Maffei', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Wenyaw', 'Initials': 'W', 'LastName': 'Chan', 'Affiliation': 'Department of Biostatistics, The University of Texas Health Science Center at Houston, School of Public Health, Houston, TX, United States.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Reyes', 'Affiliation': 'U.S. Department of Housing & Urban Development, Washington, DC, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105977']
747,32171937,Movement pattern biofeedback training after total knee arthroplasty: Randomized clinical trial protocol.,"INTRODUCTION


Total knee arthroplasty (TKA) reduces joint symptoms, but habitual movement compensations persist years after surgery. Preliminary research on movement training interventions have signaled initial efficacy for remediating movement compensations and restoring knee joint loading symmetry during dynamic functional tasks after TKA. The purpose of this clinical trial is to determine if physical rehabilitation that includes movement training restores healthy movement patterns after TKA and reduces the risk of osteoarthritis (OA) progression in the contralateral knee.
METHODS/DESIGN


150 participants will be enrolled into this randomized controlled trial. Participants will be randomly allocated to one of two dose-equivalent treatment groups: standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL). Movement training will promote between-limb symmetry and surgical knee loading during activity-based exercises. Movement training strategies will include real-time biofeedback using in-shoe pressure sensors and verbal, visual, and tactile cues from the physical therapist. The primary outcome will be change in peak knee extension moment in the surgical knee during walking, from before surgery to six months after surgery. Secondary outcomes will include lower extremity movement symmetry during functional tasks, physical function, quadriceps strength, range of motion, satisfaction, adherence, contralateral knee OA progression, and incidence of contralateral TKA.
DISCUSSION


This study will provide insights into the efficacy of movement training after unilateral TKA, along with mechanisms for optimizing long-term physical function and minimizing negative sequelae of compensatory movement patterns.",2020,Participants will be randomly allocated to one of two dose-equivalent treatment groups: standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL).,"['150 participants', 'total knee arthroplasty']","['Movement training', 'standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL', 'TKA', 'Total knee arthroplasty (TKA', 'Movement pattern biofeedback training']","['lower extremity movement symmetry during functional tasks, physical function, quadriceps strength, range of motion, satisfaction, adherence, contralateral knee OA progression, and incidence of contralateral TKA', 'risk of osteoarthritis (OA) progression', 'peak knee extension moment in the surgical knee during walking']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",150.0,0.0895054,Participants will be randomly allocated to one of two dose-equivalent treatment groups: standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bade', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America. Electronic address: michael.bade@ucdenver.edu.'}, {'ForeName': 'Jesse C', 'Initials': 'JC', 'LastName': 'Christensen', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Zeni', 'Affiliation': 'Rutgers University, School of Health Professions, Newark, NJ, United States of America.'}, {'ForeName': 'Cory L', 'Initials': 'CL', 'LastName': 'Christiansen', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Dayton', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America.'}, {'ForeName': 'Jeri E', 'Initials': 'JE', 'LastName': 'Forster', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Veterans Affairs Rocky Mountain Mental Illness, Research, Education and Clinical Center, VA Eastern Colorado Healthcare System, Aurora, CO, United States of America.'}, {'ForeName': 'Victor A', 'Initials': 'VA', 'LastName': 'Cheuy', 'Affiliation': 'University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Stevens-Lapsley', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105973']
748,32087340,"The OaSiS trial: A hybrid type II, national cluster randomized trial to implement smoking cessation during CT screening for lung cancer.","INTRODUCTION


When the Centers for Medicare and Medicaid Services announced coverage for low dose CT lung cancer screening, they also mandated that imaging centers offer smoking cessation services. We designed the Optimizing Lung Screening (OaSiS) trial to evaluate strategies to implement the Public Health Service Guidelines for Treating Tobacco Use and Dependence during CT screening for lung cancer.
METHODS AND DESIGN


OaSiS was implemented using a pragmatic effectiveness-implementation hybrid design in 26 imaging clinics across the United States affiliated with the National Cancer Institute's National Community Oncology Research Program (NCORP). The 26 sites selected for participation in the OaSiS trial were randomized to receive either a compendium of implementation strategies to add or enhance smoking cessation services during lung screening or to usual care. Usual care sites were given the option to receive the full compendium of implementation strategies at the conclusion of data collection. We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
DISCUSSION


The OaSiS trial was designed to identify opportunities for implementing evidence-based smoking cessation into LDCT lung cancer screening imaging facilities and to establish the effectiveness of these services. We report our study design and evaluation, including strengths of the pragmatic design and the inclusion of a diverse range of screening programs. Establishing these tobacco cessation services will be critical to reducing smoking related morbidity and mortality.",2020,"We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
","['patients undergoing LDCT screening', ""26 imaging clinics across the United States affiliated with the National Cancer Institute's National Community Oncology Research Program (NCORP"", '26 sites selected for participation in the OaSiS trial', 'for lung cancer']","['compendium of implementation strategies to add or enhance smoking cessation services during lung screening or to usual care', 'smoking cessation during CT screening']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035168'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",[],26.0,0.0444411,"We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
","[{'ForeName': 'Kristie Long', 'Initials': 'KL', 'LastName': 'Foley', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America. Electronic address: kfoley@wakehealth.edu.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Miller', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Internal Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Weaver', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Social Sciences and Health Policy, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Sutfin', 'Affiliation': 'Social Sciences and Health Policy, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'W Jeffrey', 'Initials': 'WJ', 'LastName': 'Petty', 'Affiliation': 'Hematology and Oncology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bellinger', 'Affiliation': 'Pulmonology and Critical Care, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Spangler', 'Affiliation': 'Family and Community Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Stone', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Lawler', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Davis', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dressler', 'Affiliation': 'Biostatistics and Data Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Lesser', 'Affiliation': 'Internal Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Hematology and Oncology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Chiles', 'Affiliation': 'Radiology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105963']
749,32087342,"The SMARTER Trial: Design of a trial testing tailored mHealth feedback to impact self-monitoring of diet, physical activity, and weight.","BACKGROUND


Self-monitoring food intake and physical activity (PA) is positively related to weight loss and the addition of feedback (FB) messages has been shown to reinforce behavior change. Moreover, the more immediate the delivery of reinforcing FB messages, the more likely they will promote the desired behaviors.
PURPOSE


Describe design and rationale of SMARTER, a National Institute of Heart, Lung, and Blood (NHLBI)-sponsored randomized, controlled trial, which compares the differential efficacy of two weight loss treatments among 530 adults, ages 18 and older.
METHODS


Single-site, 2-group design trial with subjects randomized 1:1 to either: 1) self-monitoring (SM), where participants self-monitor diet, PA, and weight using a commercial smartphone application (app); or 2) SM + FB, where participants self-monitor and receive real-time, tailored feedback (FB) as pop-up messages up to 3 times/day for 12 months. Daily FB messages address diet and PA behaviors and a weekly FB message addresses self-weighing. We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol. We will explore temporal relationships of the frequency, timing, and type of FB delivered and subsequent lifestyle behaviors through examination of serially collected real-time SM (diet, PA, weight) data over 12 months.
CONCLUSIONS


If efficacious, this fully scalable intervention could be efficiently translated and disseminated to reach large numbers of individuals through commercial apps at lower cost than existing in-person weight loss programs.",2020,"We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol.","['530 adults, ages 18 and older']","['1) self-monitoring (SM), where participants self-monitor diet, PA, and weight using a commercial smartphone application (app); or 2) SM\u202f+\u202fFB, where participants self-monitor and receive real-time, tailored feedback (FB']",['weight loss'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",530.0,0.0361057,"We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol.","[{'ForeName': 'Lora E', 'Initials': 'LE', 'LastName': 'Burke', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America. Electronic address: lbu100@pitt.edu.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Bambang', 'Initials': 'B', 'LastName': 'Parmanto', 'Affiliation': 'University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Britney', 'Initials': 'B', 'LastName': 'Beatrice', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Cajita', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'India', 'Initials': 'I', 'LastName': 'Loar', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'I Wayan', 'Initials': 'IW', 'LastName': 'Pulantara', 'Affiliation': 'University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Yuhan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Kariuki', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Cedillo', 'Affiliation': 'University of Utah, School of Medicine, Salt Lake City, UT, United States of America.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'University of Pittsburgh, Graduate School of Public Health, Department of Epidemiology, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Conroy', 'Affiliation': 'University of Utah, School of Medicine, Salt Lake City, UT, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105958']
750,31118449,Effects of different ablation strategies on long-term left atrial function in patients with paroxysmal atrial fibrillation: a single-blind randomized controlled trial.,"Restoration of sinus rhythm in atrial fibrillation (AF) by radiofrequency catheter ablation (RFCA) is associated with a transient stunning of left atrial (LA) function. However, the long-term effects of different ablation strategies on LA function remain undetermined. We performed randomized controlled trial to evaluate the effects of RFCA, cryoablation, and 3D mapping-guided cryoablation on LA function of proximal AF patients within 1 year. The 3D mapping-guided cryoablation was defined as a maximum of two cryoablation procedures for each pulmonary vein accompanied by RFCA for additional points until complete pulmonary vein isolation was achieved. Conventional and speckle tracking echocardiographic analyses were performed to evaluate LA function. Among the 210 patients (70 in each group) included, a trend of decreasing LA systolic and diastolic function was observed in all groups, as evidenced by decreases in peak A-wave velocity, the global LA peak systolic strain, the peak strain rate, the peak early diastolic strain rate, and the peak late diastolic strain rate within 7 days to 3 months after ablation followed by gradual recovery thereafter. However, the temporal changes in the above four strain parameters among the three groups did not differ significantly within 1 year after ablation (all p > 0.05). Parameters of the LA emptying fraction and LA dimensions were not significantly affected. These results suggested that stunning of LA function occurred within 7 days to 3 months after ablation, and different strategies of AF ablation did not differentially affect the temporal changes in LA function up to 1 year after ablation.",2019,"However, the temporal changes in the above four strain parameters among the three groups did not differ significantly within 1 year after ablation (all p > 0.05).","['patients with paroxysmal atrial fibrillation', '210 patients (70 in each group', 'proximal AF patients within 1 year']","['radiofrequency catheter ablation (RFCA', 'RFCA, cryoablation, and 3D mapping-guided cryoablation']","['stunning of LA function', 'LA emptying fraction and LA dimensions', 'peak A-wave velocity, the global LA peak systolic strain, the peak strain rate, the peak early diastolic strain rate, and the peak late diastolic strain rate', 'LA function', 'LA systolic and diastolic function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0162561', 'cui_str': 'Catheter Ablation, Radiofrequency'}, {'cui': 'C0010408', 'cui_str': 'Cryoablation'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C2599617', 'cui_str': 'a wave (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",210.0,0.0326991,"However, the temporal changes in the above four strain parameters among the three groups did not differ significantly within 1 year after ablation (all p > 0.05).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'You', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Bolun', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': ""Xiangya School of Medicine, Central South University, Changsha, People's Republic of China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Honglin', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Jinglan', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Guangli', 'Initials': 'G', 'LastName': 'Yin', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Chenfeng', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Ruiqin', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': ""Division of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China. xieruiqin88@163.com.""}]",Scientific reports,['10.1038/s41598-019-44168-5']
751,31118458,Clinical effect of stannous fluoride and amine fluoride containing oral hygiene products: A 4-year randomized controlled pilot study.,"This 4-year randomized controlled trial (RCT) aimed at investigating whether routine home use of both a SnCl 2 /AmF/NaF-containing mouth rinse and toothpaste has a preventive effect on oral health. Fifty-four test subjects were examined in biannual intervals. The primary endpoint ""dental erosion"" was determined by the Basic Erosive Wear Examination (BEWE). The secondary endpoints were ""saliva pH"", ""dentin hypersensitivity"" generated by Visual Analogue Scale (VAS), and ""discoloration"" measured by the Lobene Stain Index (LSI). A mixed model for repeated measures (MMRM) was used to analyze the primary endpoint ""dental erosion"". Primary analysis showed a significant intervention effect of the SnCl 2 /AmF/NaF-containing test product (p 1  = 0.0242). This result was confirmed by two additional MMRM-based sensitivity analyses. Comparison of all models showed ""dental erosion"" values of the intervention group  below values of the control group. Discoloration of the teeth was significantly higher in the intervention than in the control group at all time points. Saliva pH and dentin hypersensitivity were not significantly different between groups over four years. In summary, this RCT is the first to indicate a possible preventive effect of SnCl 2 /AmF/NaF-containing oral hygiene products on dental erosion over a follow-up period of four years.",2019,Discoloration of the teeth was significantly higher in the intervention than in the control group at all time points.,[],"['SnCl 2 /AmF/NaF-containing mouth rinse and toothpaste', 'stannous fluoride and amine fluoride containing oral hygiene products']","['dental erosion', 'Discoloration of the teeth', 'Saliva pH and dentin hypersensitivity', 'saliva pH"", ""dentin hypersensitivity"" generated by Visual Analogue Scale (VAS), and ""discoloration"" measured by the Lobene Stain Index (LSI', 'Basic Erosive Wear Examination (BEWE', 'SnCl 2 /AmF/NaF-containing test product']",[],"[{'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0002508', 'cui_str': 'Amines'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}]","[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0011432', 'cui_str': 'Tooth Sensitivity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439679', 'cui_str': 'Erosive (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0516369,Discoloration of the teeth was significantly higher in the intervention than in the control group at all time points.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Frese', 'Affiliation': 'Department of Conservative Dentistry, Clinic for Oral, Dental and Maxillofacial Diseases, Dental School, University Hospital Heidelberg, Heidelberg, Germany. cornelia.frese@med.uni-heidelberg.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wohlrab', 'Affiliation': 'Department of Conservative Dentistry, Clinic for Oral, Dental and Maxillofacial Diseases, Dental School, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sheng', 'Affiliation': 'Institute of Medical Biometry and Informatics, Ruprecht Karls University, Heidelberg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kieser', 'Affiliation': 'Institute of Medical Biometry and Informatics, Ruprecht Karls University, Heidelberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Krisam', 'Affiliation': 'Institute of Medical Biometry and Informatics, Ruprecht Karls University, Heidelberg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wolff', 'Affiliation': 'Department of Conservative Dentistry, Clinic for Oral, Dental and Maxillofacial Diseases, Dental School, University Hospital Tübingen, Tübingen, Germany.'}]",Scientific reports,['10.1038/s41598-019-44164-9']
752,32245746,Dapagliflozin Versus Placebo on Left Ventricular Remodeling in Patients With Diabetes and Heart Failure: The REFORM Trial.,"OBJECTIVE


To determine the effects of dapagliflozin in patients with heart failure (HF) and type 2 diabetes mellitus (T2DM) on left ventricular (LV) remodeling using cardiac MRI.
RESEARCH DESIGN AND METHODS


We randomized 56 patients with T2DM and HF with LV systolic dysfunction to dapagliflozin 10 mg daily or placebo for 1 year, on top of usual therapy. The primary end point was difference in LV end-systolic volume (LVESV) using cardiac MRI. Key secondary end points included other measures of LV remodeling and clinical and biochemical parameters.
RESULTS


In our cohort, dapagliflozin had no effect on LVESV or any other parameter of LV remodeling. However, it reduced diastolic blood pressure and loop diuretic requirements while increasing hemoglobin, hematocrit, and ketone bodies. There was a trend toward lower weight.
CONCLUSIONS


We were unable to determine with certainty whether dapagliflozin in patients with T2DM and HF had any effect on LV remodeling. Whether the benefits of dapagliflozin in HF are due to remodeling or other mechanisms remains unknown.",2020,"In our cohort, dapagliflozin had no effect on LVESV or any other parameter of LV remodeling.","['56 patients with T2DM and HF with LV systolic dysfunction to', 'patients with heart failure (HF) and type 2 diabetes mellitus (T2DM', 'Patients With Diabetes and Heart Failure']","['dapagliflozin 10 mg daily or placebo', 'Dapagliflozin Versus Placebo', 'dapagliflozin']","['diastolic blood pressure and loop diuretic requirements', 'lower weight', 'Left Ventricular Remodeling', 'LV remodeling', 'hemoglobin, hematocrit, and ketone bodies', 'LV end-systolic volume (LVESV) using cardiac MRI', 'LV remodeling and clinical and biochemical parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0412692', 'cui_str': 'Cardiac MRI'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",56.0,0.196478,"In our cohort, dapagliflozin had no effect on LVESV or any other parameter of LV remodeling.","[{'ForeName': 'Jagdeep S S', 'Initials': 'JSS', 'LastName': 'Singh', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Ify R', 'Initials': 'IR', 'LastName': 'Mordi', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Keeran', 'Initials': 'K', 'LastName': 'Vickneson', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Fathi', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Mohapradeep', 'Initials': 'M', 'LastName': 'Mohan', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Anna Maria J', 'Initials': 'AMJ', 'LastName': 'Choy', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gandy', 'Affiliation': 'Department of Medical Physics, NHS Tayside, Dundee, U.K.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Faisel', 'Initials': 'F', 'LastName': 'Khan', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Ewan R', 'Initials': 'ER', 'LastName': 'Pearson', 'Affiliation': 'Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'J Graeme', 'Initials': 'JG', 'LastName': 'Houston', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Chim C', 'Initials': 'CC', 'LastName': 'Lang', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K. c.c.lang@dundee.ac.uk.'}]",Diabetes care,['10.2337/dc19-2187']
753,32193044,Etomidate plus fentanyl for anesthesia in pediatric strabotomy.,"Considering the side effects of etomidate, it requires additional anesthetics to reduce the side effects and improve efficacy. Ketamine is often used as an adjunct anesthetic. We hypothesized that etomidate combined with fentanyl was more effective than etomidate combined with ketamine in the anesthesia of pediatric strabotomy. To prove our hypothesis, a prospective randomized controlled clinical study was performed, in which 35 children with strabotomy received etomidate plus ketamine (group A) for anesthesia induction and maintenance and 35 children with strabotomy received etomidate combined with fentanyl (group B). Mean arterial pressure (MAP), heart rate (HR), bispectral index (BIS), anesthesia effect, and emergence agitation and pain were observed before anesthesia induction (T1), after anesthesia induction (T2), at the beginning of the operation (T3), after 10-min operation (T4), and at the end of the operation (T5). Children in group B had significantly lower MAP and HR from T3 to T5, decreased BIS from T2 to T4, better anesthesia effect, and smaller emergence agitation and pain scores at 10 min after entering into postanesthesia care unit (PACU) compared with group A (p < 0.05). The mean emergence agitation score in group B was significantly lower than that in group A when the maximum emergence in group B was at 20 min after entering into PACU (p < 0.05). In conclusion, etomidate combined with fentanyl plays a good efficacy in anesthesia of pediatric strabotomy compared with etomidate plus ketamine.",2020,The mean emergence agitation score in group B was significantly lower than that in group A when the maximum emergence in group B was at 20 min after entering into PACU (p < 0.05).,"['35 children with strabotomy received', 'anesthesia in pediatric strabotomy', 'group A) for anesthesia induction and maintenance and 35 children with strabotomy received']","['etomidate combined with fentanyl', 'etomidate plus ketamine', 'ketamine', 'Etomidate plus fentanyl', 'etomidate', 'Ketamine']","['mean emergence agitation score', 'anesthesia effect, and smaller emergence agitation and pain scores', 'MAP and HR', 'Mean arterial pressure (MAP), heart rate (HR), bispectral index (BIS), anesthesia effect, and emergence agitation and pain were observed before anesthesia induction (T1), after anesthesia induction (T2), at the beginning of the operation (T3']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0948673', 'cui_str': 'Strabotomy'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]",35.0,0.0530917,The mean emergence agitation score in group B was significantly lower than that in group A when the maximum emergence in group B was at 20 min after entering into PACU (p < 0.05).,"[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Outpatient, Maternal and Child Health Hospital of Panzhihua, Panzhihua, Sichuan Province, China. Electronic address: huyanmc3h@163.com.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'Department of Ophthalmology, The Affiliated Hospital of Panzhihua University, Panzhihua, Sichuan Province, China.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, The 19th Metallurgical Hospital of Panzhihua, Panzhihua, Sichuan Province, China.'}]",Medical hypotheses,['10.1016/j.mehy.2020.109666']
754,32197105,"Efficacy of a tetravalent dengue vaccine in healthy children aged 4-16 years: a randomised, placebo-controlled, phase 3 trial.","BACKGROUND


A substantial unmet need remains for safe and effective vaccines against dengue virus disease, particularly for individuals who are dengue-naive and those younger than 9 years. We aimed to assess the efficacy, safety, and immunogenicity of a live attenuated tetravalent dengue vaccine (TAK-003) in healthy children aged 4-16 years.
METHODS


We present data up to 18 months post-vaccination from an ongoing phase 3, randomised, double-blind trial of TAK-003 in endemic regions of Asia and Latin America (26 medical and research centres across Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, and Thailand). Healthy children aged 4-16 years were randomly assigned 2:1 (stratified by age and region) to receive two doses of TAK-003 or two doses of placebo, 3 months apart. Investigators, participants and their parents or guardians, and sponsor representatives advising on trial conduct were masked to trial group assignments. Participants presenting with febrile illness were tested for virologically confirmed dengue (VCD) by serotype-specific RT-PCR. In timeframes beginning 30 days post-second dose, the primary endpoint (overall vaccine efficacy) was assessed in the first 11 months, and the secondary endpoints (efficacy by baseline serostatus, serotype, hospitalised dengue, and severe dengue) in the first 17 months. This study is registered with ClinicalTrials.gov, NCT02747927.
FINDINGS


20 099 participants were randomly assigned and vaccinated between Sept 7, 2016, and Aug 18, 2017; 19 021 (94·6%) were included in the per protocol analysis, and 20 071 (99·9%) in the safety set. The primary endpoint was achieved with an overall vaccine efficacy of 80·2% (95% CI 73·3 to 85·3; 61 cases of VCD in the TAK-003 group vs 149 cases of VCD in the placebo group). In the secondary endpoint assessment timeframe, an overall vaccine efficacy of 73·3% (95% CI 66·5 to 78·8) was observed. Analysis of secondary endpoints showed efficacies of 76·1% (95% CI 68·5 to 81·9) in individuals who were seropositive at baseline, 66·2% (49·1 to 77·5) in individuals who were seronegative at baseline, 90·4% (82·6 to 94·7) against hospitalised dengue, and 85·9% (31·9 to 97·1) against dengue haemorrhagic fever. Efficacy varied by individual serotypes (DENV 1, 69·8% [95% CI 54·8 to 79·9]; DENV 2, 95·1% [89·9 to 97·6]; DENV 3, 48·9% [27·2 to 64·1]; DENV 4, 51·0% [-69·4 to 85·8]). Cumulative rates of serious adverse events were similar in TAK-003 (4·0%) and placebo (4·8%) recipients, and were consistent with expected medical disorders in the study population. Infection was the most frequent reason leading to serious adverse events. 20 participants (<0·1% of the safety set) were withdrawn from the trial due to 21 adverse events by the end of part two; 14 of these participants received TAK-003 and six received placebo.
INTERPRETATION


TAK-003 was well tolerated and efficacious against symptomatic dengue in children regardless of serostatus before immunisation. Vaccine efficacy varied by serotype, warranting continued follow-up to assess longer-term vaccine performance.
FUNDING


Takeda Vaccines.",2020,"INTERPRETATION


TAK-003 was well tolerated and efficacious against symptomatic dengue in children regardless of serostatus before immunisation.","['healthy children aged 4-16 years', '20\u2008099 participants were randomly assigned and vaccinated between Sept 7, 2016, and Aug 18, 2017; 19\u2008021', 'in endemic regions of Asia and Latin America (26 medical and research centres across Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, and Thailand', 'individuals who are dengue-naive and those younger than 9 years', 'Healthy children aged 4-16 years', 'Participants presenting with febrile illness']","['TAK-003 or two doses of placebo', 'TAK-003', 'placebo', 'live attenuated tetravalent dengue vaccine (TAK-003', 'TAK-003 and six received placebo', 'tetravalent dengue vaccine']","['secondary endpoints (efficacy by baseline serostatus, serotype, hospitalised dengue, and severe dengue', 'Vaccine efficacy', 'efficacy, safety, and immunogenicity', 'Cumulative rates of serious adverse events', 'haemorrhagic fever', 'overall vaccine efficacy', 'Efficacy']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0013014', 'cui_str': 'Dominican Republic'}, {'cui': 'C0028002', 'cui_str': 'Nicaragua'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0038088', 'cui_str': 'Ceylon'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0743841', 'cui_str': 'Febrile syndrome'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}, {'cui': 'C0019100', 'cui_str': 'Philippine Hemorrhagic Fever'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019104', 'cui_str': 'Hemorrhagic Fevers, Viral'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",20099.0,0.743754,"INTERPRETATION


TAK-003 was well tolerated and efficacious against symptomatic dengue in children regardless of serostatus before immunisation.","[{'ForeName': 'Shibadas', 'Initials': 'S', 'LastName': 'Biswal', 'Affiliation': 'Takeda Vaccines, Boston, MA, USA. Electronic address: shibadas.biswal@takeda.com.'}, {'ForeName': 'Charissa', 'Initials': 'C', 'LastName': 'Borja-Tabora', 'Affiliation': 'Research Institute For Tropical Medicine, Muntinlupa, Philippines.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Martinez Vargas', 'Affiliation': 'Centro de Atención e Investigación Médica, Dominicana, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Velásquez', 'Affiliation': 'Centro de Atención e Investigación Médica, Acacias, Colombia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Theresa Alera', 'Affiliation': 'Philippines-Armed Forces Research Institute of Medical Sciences Virology Research Unit, Cebu City, Philippines.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Sierra', 'Affiliation': 'Centro de Atención e Investigación Médica, Yopal, Colombia.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Johana Rodriguez-Arenales', 'Affiliation': 'Centro de Atención e Investigación Médica, Aguazul, Colombia.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'De La Salle Medical and Health Sciences Institute, Dasmariñas, Philippines.'}, {'ForeName': 'V Pujitha', 'Initials': 'VP', 'LastName': 'Wickramasinghe', 'Affiliation': 'University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Duarte Moreira', 'Affiliation': 'Associação Obras Sociais Irmã Dulce Hospital Santo Antônio and Oswaldo Cruz Foundation, Bahia, Brazil.'}, {'ForeName': 'Asvini D', 'Initials': 'AD', 'LastName': 'Fernando', 'Affiliation': 'Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.'}, {'ForeName': 'Dulanie', 'Initials': 'D', 'LastName': 'Gunasekera', 'Affiliation': 'Faculty of Medical Sciences, University of Sri Jayawardenenpura, Gangodawila, Sri Lanka.'}, {'ForeName': 'Pope', 'Initials': 'P', 'LastName': 'Kosalaraksa', 'Affiliation': 'Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Espinoza', 'Affiliation': 'National Autonomous University of Nicaragua, León, Nicaragua.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'López-Medina', 'Affiliation': 'Centro de Estudios en Infectología Pediátrica, Universidad del Valle and Centro Médico Imbanaco, Cali, Colombia.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Bravo', 'Affiliation': 'University of the Philippines Manila, Ermita, Philippines.'}, {'ForeName': 'Suely', 'Initials': 'S', 'LastName': 'Tuboi', 'Affiliation': 'Takeda Pharmaceuticals, São Paulo, Brazil.'}, {'ForeName': 'Yanee', 'Initials': 'Y', 'LastName': 'Hutagalung', 'Affiliation': 'Takeda Vaccines, Singapore.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Garbes', 'Affiliation': 'Takeda Vaccines, Boston, MA, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Escudero', 'Affiliation': 'Takeda Vaccines, Singapore.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Rauscher', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Bizjajeva', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'LeFevre', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Saez-Llorens', 'Affiliation': 'Hospital del Niño Dr José Renán Esquivel, Sistema Nacional de Investigación at Secretaría Nacional de Ciencia y Tecnología, Centro de Vacunación Internacional (Cevaxin), Panama City, Panama.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'Takeda Vaccines, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30414-1']
755,32092439,Evaluating the effect of individually-targeted food incentives on grocery purchases: The smart cart study protocol for a randomized controlled cross-over trial.,"BACKGROUND/AIMS


Health stakeholders are interested in the promise of healthy food incentives to improve dietary quality. The Smart Cart Study tested whether targeting healthful food incentives based on customer preferences and purchase history was effective for improving grocery purchase quality.
DESIGN


Randomized controlled crossover design of 224 adults who shopped at an independent supermarket for ≥50% of their groceries, participated in the store's loyalty program, and completed validated diet and sociodemographic/behavioral questionnaires. Participants were randomized using 1:1 blocked randomization; all participants received a 5% discount on their purchases with their loyalty card. For the first 13-weeks, the intervention group received individually-targeted weekly coupons (valued up to $10) with brief nutrition education to improve grocery purchase quality. The study team developed healthy food coupons, and the study algorithm allocated targeted coupons to participants' loyalty cards using purchase history, dietary preferences/allergies, and baseline diet quality. Control participants received weekly untargeted nutrition education and occasional generic coupons. Following a 2-4 week washout period, the two groups crossed over. The primary study outcomes were purchases of targeted products and grocery purchase quality measured using the validated Grocery Purchase Quality Index-2016; the study was powered to detect a minimum 3% difference in purchase quality.
CONCLUSIONS


The Smart Cart Study tested a novel application of automated individually-targeted marketing using customer purchase history, dietary quality, and preferences to identify and deliver targeted incentives to improve grocery purchase quality. Future research could scale this program through collaboration between multiple stakeholders, including supermarkets, workplace wellness initiatives and insurance companies.",2020,"The Smart Cart Study tested whether targeting healthful food incentives based on customer preferences and purchase history was effective for improving grocery purchase quality.
","[""224 adults who shopped at an independent supermarket for ≥50% of their groceries, participated in the store's loyalty program, and completed validated diet and sociodemographic/behavioral questionnaires""]","['untargeted nutrition education and occasional generic coupons', 'individually-targeted weekly coupons (valued up to $10) with brief nutrition education']","['purchase quality', 'purchases of targeted products and grocery purchase quality']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0700383', 'cui_str': 'Shop (environment)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0557778', 'cui_str': 'Supermarket (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0521114', 'cui_str': 'Infrequent (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",224.0,0.0760648,"The Smart Cart Study tested whether targeting healthful food incentives based on customer preferences and purchase history was effective for improving grocery purchase quality.
","[{'ForeName': 'Maya K', 'Initials': 'MK', 'LastName': 'Vadiveloo', 'Affiliation': 'Department of Nutrition and Food Sciences, College of Health Sciences, University of Rhode Island, Kingston, RI, United States of America. Electronic address: Maya_vadiveloo@uri.edu.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Marketing Area, College of Business Administration, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Haley W', 'Initials': 'HW', 'LastName': 'Parker', 'Affiliation': 'Department of Nutrition and Food Sciences, College of Health Sciences, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Perraud', 'Affiliation': 'AgroParis Tech., 75231 Paris, Ile-de-France, France.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Buchanan', 'Affiliation': 'Department of Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Atlas', 'Affiliation': 'Marketing Area, College of Business Administration, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'General Internal Medicine Division, Department of Medicine, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105966']
756,30661836,"An observer blinded, randomized, placebo-controlled, phase I dose escalation trial to evaluate the safety and immunogenicity of an inactivated West Nile virus Vaccine, HydroVax-001, in healthy adults.","BACKGROUND


West Nile virus (WNV) is the most common mosquito-borne infection in the United States. HydroVax-001 WNV is a hydrogen peroxide inactivated, whole virion (WNV-Kunjin strain) vaccine adjuvanted with aluminum hydroxide.
METHODS


We performed a phase 1, randomized, placebo-controlled, double-blind (within dosing group), dose escalation clinical trial of the HydroVax-001 WNV vaccine administered via intramuscular injection. This trial evaluated 1 mcg and 4 mcg dosages of HydroVax-001 WNV vaccine given intramuscularly on day 1 and day 29 in healthy adults. The two dosing groups of HydroVax-001 were enrolled sequentially and each group consisted of 20 individuals who received HydroVax-001 and 5 who received placebo. Safety was assessed at all study days (days 1, 2, 4 and 15 post dose 1, and days 1, 2, 4, 15, 29, 57, 180 and 365 post dose 2), and reactogenicity was assessed for 14 days after administration of each dose. Immunogenicity was measured by WNV-specific plaque reduction neutralization tests (PRNT 50 ) in the presence or absence of added complement or by WNV-specific enzyme-linked immunosorbent assays (ELISA).
RESULTS


HydroVax-001 was safe and well-tolerated as there were no serious adverse events or concerning safety signals. At the 1 mcg dose, HydroVax-001 was not immunogenic by PRNT 50  but elicited up to 41% seroconversion by WNV-specific ELISA in the per-protocol population (PP) after the second dose. At the 4 mcg dose, HydroVax-001 elicited neutralizing antibody responses in 31% of the PP following the second dose. In the presence of added complement, PRNT 50  seroconversion rates increased to 50%, and 75% seroconversion was observed by WNV-specific ELISA.
CONCLUSIONS


The HydroVax-001 WNV vaccine was found to be modestly immunogenic and well-tolerated at all dose levels.",2019,"RESULTS


HydroVax-001 was safe and well-tolerated as there were no serious adverse events or concerning safety signals.",['healthy adults'],"['placebo', 'HydroVax-001 WNV vaccine', 'HydroVax-001', 'HydroVax-001 and 5 who received placebo', 'inactivated West Nile virus Vaccine, HydroVax-001', 'aluminum hydroxide']","['HydroVax-001 elicited neutralizing antibody responses', 'Immunogenicity', 'seroconversion rates', 'reactogenicity', 'modestly immunogenic and well-tolerated', 'safety and immunogenicity', 'safe and well-tolerated', 'Safety']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1299874', 'cui_str': 'West Nile Virus Vaccines'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}]","[{'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.307203,"RESULTS


HydroVax-001 was safe and well-tolerated as there were no serious adverse events or concerning safety signals.","[{'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Woods', 'Affiliation': 'Duke Department of Medicine, Duke University School of Medicine, Durham, NC, USA. Electronic address: chris.woods@duke.edu.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Sanchez', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Duke Department of Gynecology and Obstetrics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Micah T', 'Initials': 'MT', 'LastName': 'McClain', 'Affiliation': 'Duke Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Harrington', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Duke Early Phase Research Unit, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Poore', 'Affiliation': 'Najít Technologies Inc., Beaverton, OR, USA.'}, {'ForeName': 'Dawn K', 'Initials': 'DK', 'LastName': 'Slifka', 'Affiliation': 'Najít Technologies Inc., Beaverton, OR, USA.'}, {'ForeName': 'Danae E', 'Initials': 'DE', 'LastName': 'Poer DeRaad', 'Affiliation': 'Najít Technologies Inc., Beaverton, OR, USA.'}, {'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Amanna', 'Affiliation': 'Najít Technologies Inc., Beaverton, OR, USA.'}, {'ForeName': 'Mark K', 'Initials': 'MK', 'LastName': 'Slifka', 'Affiliation': 'Division of Neuroscience, Oregon National Primate Research Center, Oregon Health & Science University, Beaverton, OR, USA.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'National Institutes of Health, Division of Microbiology and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Venus', 'Initials': 'V', 'LastName': 'Shahamatdar', 'Affiliation': 'National Institutes of Health, Division of Microbiology and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Wierzbicki', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Amegashie', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Emmanuel B', 'Initials': 'EB', 'LastName': 'Walter', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.'}]",Vaccine,['10.1016/j.vaccine.2018.12.026']
757,32239968,Preterm Infants Fed Cow's Milk-Derived Fortifier Had Adverse Outcomes Despite a Base Diet of Only Mother's Own Milk.,"Objective:  An increasingly common practice is to feed preterm infants a base diet comprising only human milk (HM), usually fortified with a cow's milk (CM)-derived fortifier (CMDF). We evaluated the safety of CMDF in a diet of 100% mother's own milk (MOM) against a HM-derived fortifier (HMDF). To date, this has received little research attention.  Study Design:  We reanalyzed a 12-center randomized trial, originally comparing exclusive HM feeding, including MOM, donor milk (DM), and HMDF, versus a CM exposed group fed MOM, preterm formula (PTF), and CMDF1. However, for the current study, we performed a subgroup analysis ( n  = 114) selecting only infants receiving 100% MOM base diet plus fortification, and fed no DM or PTF. This allowed for an isolated comparison of fortifier type: CMDF versus HMDF to evaluate the primary outcomes: necrotizing enterocolitis (NEC) and a severe morbidity index of NEC surgery or death; and several secondary outcomes.  Results:  CMDF and HMDF groups had similar baseline characteristics. CMDF was associated with higher risk of NEC; relative risk (RR) 4.2 ( p  = 0.038), NEC surgery or death (RR 5.1,  p  = 0.014); and reduced head circumference gain ( p  = 0.04).  Conclusions:  In neonates fed, as currently recommended with a MOM-based diet, the safety of CMDF when compared to HMDF has been little researched. We conclude that available evidence points to an increase in adverse outcomes with CMDF, including NEC and severe morbidity comprising NEC surgery or death.",2020,"CMDF was associated with higher risk of NEC; relative risk (RR) 4.2 ( p  = 0.038), NEC surgery or death (RR 5.1,  p  = 0.014); and reduced head circumference gain ( p  = 0.04).  ",[],"['CMDF', 'MOM base diet plus fortification, and fed no DM or PTF', 'MOM, donor milk (DM), and HMDF, versus a CM exposed group fed MOM, preterm formula (PTF), and CMDF1']","['adverse outcomes with CMDF, including NEC and severe morbidity comprising NEC surgery or death', 'NEC surgery or death', 'head circumference gain']",[],"[{'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206695', 'cui_str': 'Neuroendocrine carcinoma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}]",114.0,0.181336,"CMDF was associated with higher risk of NEC; relative risk (RR) 4.2 ( p  = 0.038), NEC surgery or death (RR 5.1,  p  = 0.014); and reduced head circumference gain ( p  = 0.04).  ","[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Lucas', 'Affiliation': 'Institute of Child Health, University College, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boscardin', 'Affiliation': 'Department of Medicine and University of California, San Francisco, California, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Abrams', 'Affiliation': 'Department of Pediatrics, Dell Medical School, The University of Texas, Austin, Texas, USA.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2019.0133']
758,31181564,A randomized trial of an NMDA receptor antagonist for reversing corticosteroid effects on the human hippocampus.,"Preclinical and clinical research indicates that excess corticosteroid is associated with adverse effects on the hippocampus. Animal model data suggest that N-methyl-D-aspartate (NMDA) receptor antagonists may block corticosteroid effect on the hippocampus. This translational clinical trial investigated the effect of memantine vs. placebo on hippocampal subfield volume in humans receiving chronic corticosteroid therapy. Men and women (N = 46) receiving chronic prescription corticosteroid therapy were randomized to memantine or placebo in a double-blind, crossover design (two 24-week treatment periods, separated by a 4-week washout) for 52 weeks. Structural magnetic resonance imaging was obtained at baseline and after each treatment. Data were analyzed using repeated measures analysis of variance. Mean corticosteroid dose was 7.69 ± 6.41 mg/day and mean duration 4.90 ± 5.61 years. Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011). The findings suggest that an NMDA receptor antagonist attenuates corticosteroid effect in the same hippocampal subfields in humans as in animal models. This finding has both mechanistic and clinical implications. Attenuation of the effect of corticosteroids on the human DG/CA3 region implicates the NMDA receptor in human hippocampal volume losses with corticosteroids. In addition, by suggesting a drug class that may, at least in part, block the effects of corticosteroids on the human DG/CA3 subfield, these results may have clinical relevance for people receiving prescription corticosteroids, as well as to those with cortisol elevations due to medical or psychiatric conditions.",2019,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","['Men and women (N\u2009=\u200946) receiving chronic prescription corticosteroid therapy', 'humans receiving chronic corticosteroid therapy']","['NMDA receptor antagonist', 'placebo', 'memantine or placebo', 'memantine vs. placebo', 'memantine', 'corticosteroids']","['left DG/CA3 region', 'hippocampal subfield volume']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.420896,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","[{'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA. Sherwood.Brown@UTSouthwestern.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kulikova', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Enkevort', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Ivleva', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yassa', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Departments of Radiology and the Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Frol', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vazquez', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0430-8']
759,31882527,"Imaging markers of small vessel disease and brain frailty, and outcomes in acute stroke.","OBJECTIVE


To assess the association of baseline imaging markers of cerebral small vessel disease (SVD) and brain frailty with clinical outcome after acute stroke in the Efficacy of Nitric Oxide in Stroke (ENOS) trial.
METHODS


ENOS randomized 4,011 patients with acute stroke (<48 hours of onset) to transdermal glyceryl trinitrate (GTN) or no GTN for 7 days. The primary outcome was functional outcome (modified Rankin Scale [mRS] score) at day 90. Cognition was assessed via telephone at day 90. Stroke syndrome was classified with the Oxfordshire Community Stroke Project classification. Brain imaging was adjudicated masked to clinical information and treatment and assessed SVD (leukoaraiosis, old lacunar infarcts/lacunes, atrophy) and brain frailty (leukoaraiosis, atrophy, old vascular lesions/infarcts). Analyses used ordinal logistic regression adjusted for prognostic variables.
RESULTS


In all participants and those with lacunar syndrome (LACS; 1,397, 34.8%), baseline CT imaging features of SVD and brain frailty were common and independently associated with unfavorable shifts in mRS score at day 90 (all participants: SVD score odds ratio [OR] 1.15, 95% confidence interval [CI] 1.07-1.24; brain frailty score OR 1.25, 95% CI 1.17-1.34; those with LACS: SVD score OR 1.30, 95% CI 1.15-1.47, brain frailty score OR 1.28, 95% CI 1.14-1.44). Brain frailty was associated with worse cognitive scores at 90 days in all participants and in those with LACS.
CONCLUSIONS


Baseline imaging features of SVD and brain frailty were common in lacunar stroke and all stroke, predicted worse prognosis after all acute stroke with a stronger effect in lacunar stroke, and may aid future clinical decision-making.
IDENTIFIER


ISRCTN99414122.",2020,The primary outcome was functional outcome,"['acute stroke', '4,011 patients with acute stroke (<48 hours of onset) to', 'for 7 days']","['Nitric Oxide', 'transdermal glyceryl trinitrate (GTN) or no GTN']","['baseline CT imaging features of SVD and brain frailty', 'functional outcome', 'Brain frailty', 'SVD (leukoaraiosis, old lacunar infarcts/lacunes, atrophy) and brain frailty (leukoaraiosis, atrophy, old vascular lesions/infarcts', 'worse cognitive scores', 'mRS score']","[{'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0948163', 'cui_str': 'Leukoaraiosis'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0333559', 'cui_str': 'Infarct, Lacunar'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",4011.0,0.286948,The primary outcome was functional outcome,"[{'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Appleton', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Woodhouse', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Adami', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Becker', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Berge', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Cala', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Casado', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Caso', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': 'Hanne K', 'Initials': 'HK', 'LastName': 'Christensen', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Dineen', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gommans', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': 'Panos', 'Initials': 'P', 'LastName': 'Koumellis', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': 'Szabolcs', 'Initials': 'S', 'LastName': 'Szatmari', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK. Philip.bath@nottingham.ac.uk.""}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Wardlaw', 'Affiliation': ""From the Stroke Trials Unit (J.P.A., L.J.W., N.S., P.M.B.) and Radiological Sciences Research Group (R.A.D.), Division of Clinical Neurosciences, University of Nottingham; Stroke (J.P.A., N.S., P.M.B.), Nottingham University Hospitals NHS Trust, UK; Stroke Center (A.A.), IRCSS Sacro Cuore-Don Calabria Hospital, Negrar, Verona, Italy; Department of Medical Imaging (J.L.B.), College of Medicine, University of Arizona, Tucson; Department of Internal Medicine and Cardiology (E.B.), Oslo University Hospital, Norway; School of Medicine (L.A.C.), University of Western Australia, Crawley; Department of Neuroradiology (A.M.C.), Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK; Stroke Unit (V.C.), Santa Maria della Misericordia Hospital, University of Perugia, Italy; Neurology (H.K.C.), Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine (J.G.), Hawke's Bay District Health Board, Hastings, New Zealand; Department of Neuroradiology (P.K.), Nottingham University Hospitals, Queen's Medical Centre, UK; Department of Neurology (S.S.), Clinical County Emergency Hospital, Targu Mures, Romania; and Division of Neuroimaging Sciences (J.M.W.), Centre for Clinical Brain Sciences, Dementia Research Institute, University of Edinburgh, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000008881']
760,32184197,A stepped-wedge randomized trial protocol of a community intervention for increasing lung screening through engaging primary care providers (I-STEP).,"Lung cancer screening with low-dose computed tomography (LDCT) reduces lung cancer mortality, yet few eligible high-risk patients receive it annually. This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways. This study uses a stepped-wedge implementation design. Screening centers are randomized by readiness level to enter the intervention phase in three-month ""steps"" with pre-intervention data serving as the control. The primary outcome is whether delivery of the Toolkit to primary care practices results in a monthly increase in number of initial LDCT screenings. Six participating centers will identify 10 practices and reach 2-3 providers per practice to train them to use the Toolkit. The Toolkit will address known barriers to screening and referral at the patient and provider levels and provide support for required elements of screening. Toolkit components include adaptable evidence-based interventions to maximize compatibility with workflows. We hypothesize that after nine months of intervention delivery, the number of initial screening per center will double. Involving 60 practices achieves 80% power at 5% level of significance. Implementation outcomes such as adoption, acceptability, feasibility, adaptation, and sustainability will be assessed through field-notes and activity logs. LDCT for lung cancer screening currently reaches a small fraction of eligible adults. To reach the full potential to reduce mortality, primary care practices are an important venue for increasing appropriate referrals. This multidisciplinary trial will encourage acceptability and sustainability by using local knowledge and promoting partnership between providers and patients. Trial registration: ClinicalTrials.gov, NCT03958253.",2020,This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways.,[],"['LDCT', 'Lung cancer screening with low-dose computed tomography (LDCT', 'community-partnered intervention (Toolkit) designed to support primary care practices', 'community intervention']","['adoption, acceptability, feasibility, adaptation, and sustainability will be assessed through field-notes and activity logs', 'delivery of the Toolkit to primary care practices results in a monthly increase in number of initial LDCT screenings', 'lung cancer mortality']",[],"[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.158435,This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways.,"[{'ForeName': 'Ana S', 'Initials': 'AS', 'LastName': 'Salazar', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: a.salaza@wustl.edu.'}, {'ForeName': 'Subhjit', 'Initials': 'S', 'LastName': 'Sekhon', 'Affiliation': 'University of Missouri-Kansas City, USA. Electronic address: sks3t4@mail.umkc.edu.'}, {'ForeName': 'Karthik W', 'Initials': 'KW', 'LastName': 'Rohatgi', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: karthik.rohatgi@wustl.edu.'}, {'ForeName': 'Akua', 'Initials': 'A', 'LastName': 'Nuako', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: aanuako@wustl.edu.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: esther@wustl.edu.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Harriss', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: courtney.harriss@wustl.edu.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Brennan', 'Affiliation': 'Siteman Cancer Center at Barnes-Jewish St. Peters Hospital, 150 Entrance Way, St. Peters, MO 63376, USA. Electronic address: ellen.brennan@bjc.org.'}, {'ForeName': 'Dareld', 'Initials': 'D', 'LastName': 'LaBeau', 'Affiliation': 'Siteman Cancer Center at Barnes-Jewish St. Peters Hospital, 150 Entrance Way, St. Peters, MO 63376, USA. Electronic address: dareld.labeau@bjc.org.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abdalla', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: ibrahim.abdalla@coxhealth.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Schulze', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: chris.schulze@coxhealth.com.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Muenks', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: jackie.muenks@coxhealth.com.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Overlot', 'Affiliation': 'Cancer Care Center of Decatur, Decatur Memorial Hospital, 210 W. McKinley Avenue, Decatur, IL 62526, USA. Electronic address: daveo@dmhhs.org.'}, {'ForeName': 'Jeri Ann', 'Initials': 'JA', 'LastName': 'Higgins', 'Affiliation': 'Cancer Care Center of Decatur, Decatur Memorial Hospital, 210 W. McKinley Avenue, Decatur, IL 62526, USA. Electronic address: jerih@dmhhs.org.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Jones', 'Affiliation': 'Regional Cancer Center, Memorial Health System, 701 N 1(st), Springfield, IL 62781, USA. Electronic address: jones.linda@mhsil.com.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Swick', 'Affiliation': 'Sarah Bush Lincoln Regional Cancer Center, Sarah Bush Lincoln Health System, 1001 Health Center Drive, Mattoon, IL 61938, USA. Electronic address: cswick@sblhs.org.'}, {'ForeName': 'Stacia', 'Initials': 'S', 'LastName': 'Goings', 'Affiliation': 'Sarah Bush Lincoln Regional Cancer Center, Sarah Bush Lincoln Health System, 1001 Health Center Drive, Mattoon, IL 61938, USA. Electronic address: sgoings@sblhs.org.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Badiu', 'Affiliation': 'SIH Cancer Institute, Southern Illinois Healthcare, 1400 Pin Oak Drive, Carterville, IL 62918, USA. Electronic address: jennifer.badiu@sih.net.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'SIH Cancer Institute, Southern Illinois Healthcare, 1400 Pin Oak Drive, Carterville, IL 62918, USA. Electronic address: Justin.Walker@sih.net.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'Colditz', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: colditzg@wustl.edu.'}, {'ForeName': 'Aimee S', 'Initials': 'AS', 'LastName': 'James', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: aimeejames@wustl.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105991']
761,32184198,The efficacy of written exposure therapy versus imaginal exposure delivered online for posttraumatic stress disorder: Design of a randomized controlled trial in Veterans.,"Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD). This paper describes the rationale for and methods of a randomized controlled trial comparing the efficacy and efficiency of written exposure therapy versus imaginal exposure for PTSD delivered in a novel online and variable length format. Participants will be 300 Veterans seeking treatment for clinically significant symptoms of PTSD. Participants will be randomly assigned to either written exposure or imaginal exposure via verbal recounting and will complete between 4 and 8 online therapy sessions facilitated by trained peer support specialists. Treatment is terminated before session 8 if the PTSD symptom improvement criterion is met. Assessments will be conducted at baseline, post-treatment, and at 3-month follow-up. The primary hypotheses are that written exposure therapy will be noninferior to imaginal exposure with respect to treatment efficacy and efficiency. Secondary hypotheses relate to identifying and comparing potential mediators of PTSD treatment outcome, including trauma-related cognitions and emotion regulation.",2020,Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD).,"['posttraumatic stress disorder', 'Veterans with posttraumatic stress disorder (PTSD', '300 Veterans seeking treatment for clinically significant symptoms of PTSD', 'Veterans']","['written exposure therapy versus imaginal exposure for PTSD', 'written exposure therapy versus imaginal exposure delivered online', 'written exposure or imaginal exposure via verbal recounting and will complete between 4 and 8 online therapy sessions facilitated by trained peer support specialists']",['trauma-related cognitions and emotion regulation'],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}]","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",300.0,0.026439,Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD).,"[{'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA 94025, USA; Stanford University, Department of Psychiatry and Behavioral Sciences, School of Medicine, 401 Quarry Road, Stanford, CA 94305, USA. Electronic address: Carmen.McLean4@va.gov.'}, {'ForeName': 'Madeleine L', 'Initials': 'ML', 'LastName': 'Miller', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA 94025, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gengler', 'Affiliation': 'Prevail Health Solutions, LLC, 105 W Chicago Ave #203, Chicago, IL 60642, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Prevail Health Solutions, LLC, 105 W Chicago Ave #203, Chicago, IL 60642, USA.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Sloan', 'Affiliation': 'National Center for PTSD, Behavioral Science Division, VA Boston Healthcare System, 150 S Huntington Ave, Boston, MA 02130, USA; Boston University School of Medicine, 72 E Concord St, Boston, MA 02118, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105990']
762,31375874,Effects of milk powder intervention on bone mineral density and indicators related to bone metabolism in Chinese adolescents.,"The study is to determine the effects of milk powder on bone density and metabolism in healthy adolescents. Vitamin D and calcium supplements increased IGF-1 but did not affect bone mineralization or turnover. Higher vitamin D in combination with sufficient calcium supplementation in such populations requires attention.
INTRODUCTION


Both calcium and vitamin D play an important role in bone mineralization in adolescents.
METHODS


In this one and a half-year randomized controlled trial, 232 participants (aged 12-15 years) were randomly assigned to three intervention groups receiving milk powder fortified with vitamin D 400 IU plus calcium 300, or 600, or 900 mg [Ca3D (n = 54), Ca6D (n = 56), and Ca9D (n = 49)], or one control group maintaining habitual diet [control (n = 73)]. Bone turnover markers, serum intact PTH, 25(OH)D, and IGF-1 levels were measured at baseline and one and a half years, and bone mineral contents and bone areal mineral density were measured by Dual-energy X-ray absorptiometry (DXA) at baseline, one year, and one and a half years.
RESULTS


Baseline average serum 25(OH)D level and calcium intake were 29.4 nmol/L and 363.5 mg/day, respectively. There was a significant increase in bone turnover, total body, hip, lumbar spine bone mineral density (BMD), and total body BMC as well as slight fluctuations in 25(OH)D levels over one and a half years without between-group differences. Significantly decreased serum PTH level was only observed in the Ca6D group (31%, p < 0.0001), in which the intervention effect was also significant (p = 0.0029) compared with the control group. IGF-1 levels increased significantly in all intervention groups (18.5 to 22.8%, p < 0.05) but decreased in the control group (16.5%, p < 0.05), and the group by time interaction was also significant (p = 0.0029).
CONCLUSIONS


Our study showed that in healthy adolescents with low vitamin D status and calcium intake, mild vitamin D and mild to modest calcium supplements increased IGF-1 but did not affect bone mineralization or turnover. Higher vitamin D in combination with sufficient calcium supplementation in such populations requires attention.",2019,"IGF-1 levels increased significantly in all intervention groups (18.5 to 22.8%, p < 0.05) but decreased in the control group (16.5%, p < 0.05), and the group by time interaction was also significant (p = 0.0029).
","['healthy adolescents', 'adolescents', '232 participants (aged 12-15\xa0years', 'Chinese adolescents']","['calcium and vitamin D', 'milk powder intervention', 'control group maintaining habitual diet [control', 'Vitamin D and calcium supplements', 'milk powder', 'milk powder fortified with vitamin D 400\xa0IU plus calcium 300, or 600, or 900\xa0mg [Ca3D']","['Bone turnover markers, serum intact PTH, 25(OH)D, and IGF-1 levels', 'serum PTH level', 'serum 25(OH)D level and calcium intake', 'IGF-1', 'bone turnover, total body, hip, lumbar spine bone mineral density (BMD), and total body BMC as well as slight fluctuations in 25(OH)D levels', 'bone density and metabolism', 'bone mineralization or turnover', 'IGF-1 levels', 'bone mineral contents and bone areal mineral density', 'bone mineral density and indicators related to bone metabolism']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement (substance)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}]","[{'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C2350989', 'cui_str': 'Bone Mineralization'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",232.0,0.0742661,"IGF-1 levels increased significantly in all intervention groups (18.5 to 22.8%, p < 0.05) but decreased in the control group (16.5%, p < 0.05), and the group by time interaction was also significant (p = 0.0029).
","[{'ForeName': 'J X', 'Initials': 'JX', 'LastName': 'Lu', 'Affiliation': 'National Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention, 29 Nan Wei Road, Xi Cheng District, Beijing, 100050, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'National Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention, 29 Nan Wei Road, Xi Cheng District, Beijing, 100050, China.'}, {'ForeName': 'X Q', 'Initials': 'XQ', 'LastName': 'Hu', 'Affiliation': 'National Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention, 29 Nan Wei Road, Xi Cheng District, Beijing, 100050, China.'}, {'ForeName': 'Z W', 'Initials': 'ZW', 'LastName': 'Huang', 'Affiliation': 'National Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention, 29 Nan Wei Road, Xi Cheng District, Beijing, 100050, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'National Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention, 29 Nan Wei Road, Xi Cheng District, Beijing, 100050, China. zhangqian7208@163.com.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-05105-4']
763,31392401,Study of twice-weekly injections of Teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients: the TWICE study.,"A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial (the TWICE study) conducted in Japanese primary osteoporosis patients with a high risk of fractures demonstrated that a 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen of teriparatide, while also improving safety.
INTRODUCTION


While a 56.5-μg once-weekly regimen of teriparatide has high efficacy for osteoporosis, treatment continuation rates are low, with one of the major causes being adverse drug reactions such as nausea or vomiting. The TWICE study was therefore conducted to investigate whether a twice-weekly regimen with 28.2-μg teriparatide can provide comparable efficacy to the 56.5-μg once-weekly regimen while improving safety.
METHODS


A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan. Patients with primary osteoporosis aged ≥ 65 years at high risk of fractures (n = 553) were randomly allocated to the 28.2-μg twice-weekly group (n = 277) or the 56.5-μg once-weekly group (n = 276). The primary endpoint was the percentage change in lumbar spine (L2-L4) bone mineral density (BMD) at final follow-up.
RESULTS


The percentage changes in lumbar spine (L2-L4) BMD at final follow-up in the 28.2-μg twice-weekly and 56.5-μg once-weekly groups were 7.3% and 5.9%, respectively; the difference (95% confidence interval [CI]) in percentage change was 1.3% (0.400-2.283%). Since the lower limit of the 95% CI was above the pre-specified non-inferiority margin (- 1.6%), non-inferiority of the 28.2-μg twice-weekly group was demonstrated. Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group.
CONCLUSIONS


A 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen while improving safety.
CLINICAL TRIAL REGISTRATION


JapicCTI-163477 .",2019,"Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group.
","['Japanese primary osteoporosis patients with a high risk of fractures', 'Japan', 'Patients with primary osteoporosis aged ≥', 'osteoporosis', 'osteoporosis patients', '65\xa0years at high risk of fractures (n\u2009=\u2009553']","['teriparatide', 'Teriparatide']","['percentage change in lumbar spine (L2-L4) bone mineral density (BMD', 'safety', 'Adverse drug reactions', 'adverse drug reactions', 'nausea or vomiting', 'incidence of major adverse drug reactions', 'lumbar spine (L2-L4) BMD']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0410438', 'cui_str': 'Primary osteoporosis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",553.0,0.409506,"Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group.
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Internal Medicine 1, Shimane University Faculty of Medicine, 89-1 Ennya-cho, Izumo, Shimane, 693-8501, Japan. sugimoto@med.shimane-u.ac.jp.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shiraki', 'Affiliation': 'Research Institute and Practice for Involutional Diseases, 1610-1 Misatomeisei, Azumino, Nagano, 399-8101, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fukunaga', 'Affiliation': 'Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kishimoto', 'Affiliation': 'Nojima Hospital, 2714-1 Sesakimachi, Kurayoshi, Tottori, 682-0863, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hagino', 'Affiliation': 'School of Health Science, Tottori University, 86 Nishicho, Yonago, Tottori, 683-8503, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sone', 'Affiliation': 'Department of Nuclear Medicine, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nakano', 'Affiliation': 'Tamana Central Hospital, 1950 Naka, Tamana, Kumamoto, 865-0064, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Center for Diversity and Inclusion, Nagasaki University, 1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8520, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Orthopaedic Surgery, Graduated School of Medicine, Osaka University, 1-1 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Minamida', 'Affiliation': 'Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tsuruya', 'Affiliation': 'Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Toto Sangenjaya Rehabilitation Hospital, 1-24-3 Sangenjaya, Setagaya-ku, Tokyo, 154-0024, Japan.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-05111-6']
764,31334795,Intensive vs Standard Treatment of Hyperglycemia and Functional Outcome in Patients With Acute Ischemic Stroke: The SHINE Randomized Clinical Trial.,"Importance


Hyperglycemia during acute ischemic stroke is common and is associated with worse outcomes. The efficacy of intensive treatment of hyperglycemia in this setting remains unknown.
Objectives


To determine the efficacy of intensive treatment of hyperglycemia during acute ischemic stroke.
Design, Setting, and Participants


The Stroke Hyperglycemia Insulin Network Effort (SHINE) randomized clinical trial included adult patients with hyperglycemia (glucose concentration of >110 mg/dL if had diabetes or ≥150 mg/dL if did not have diabetes) and acute ischemic stroke who were enrolled within 12 hours from stroke onset at 63 US sites between April 2012 and August 2018; follow-up ended in November 2018. The trial included 1151 patients who met eligibility criteria.
Interventions


Patients were randomized to receive continuous intravenous insulin using a computerized decision support tool (target blood glucose concentration of 80-130 mg/dL [4.4-7.2 mmol/L]; intensive treatment group: n = 581) or insulin on a sliding scale that was administered subcutaneously (target blood glucose concentration of 80-179 mg/dL [4.4-9.9 mmol/L]; standard treatment group: n = 570) for up to 72 hours.
Main Outcomes and Measures


The primary efficacy outcome was the proportion of patients with a favorable outcome based on the 90-day modified Rankin Scale score (a global stroke disability scale ranging from 0 [no symptoms or completely recovered] to 6 [death]) that was adjusted for baseline stroke severity.
Results


Among 1151 patients who were randomized (mean age, 66 years [SD, 13.1 years]; 529 [46%] women, 920 [80%] with diabetes), 1118 (97%) completed the trial. Enrollment was stopped for futility based on prespecified interim analysis criteria. During treatment, the mean blood glucose level was 118 mg/dL (6.6 mmol/L) in the intensive treatment group and 179 mg/dL (9.9 mmol/L) in the standard treatment group. A favorable outcome occurred in 119 of 581 patients (20.5%) in the intensive treatment group and in 123 of 570 patients (21.6%) in the standard treatment group (adjusted relative risk, 0.97 [95% CI, 0.87 to 1.08], P = .55; unadjusted risk difference, -0.83% [95% CI, -5.72% to 4.06%]). Treatment was stopped early for hypoglycemia or other adverse events in 65 of 581 patients (11.2%) in the intensive treatment group and in 18 of 570 patients (3.2%) in the standard treatment group. Severe hypoglycemia occurred only among patients in the intensive treatment group (15/581 [2.6%]; risk difference, 2.58% [95% CI, 1.29% to 3.87%]).
Conclusions and Relevance


Among patients with acute ischemic stroke and hyperglycemia, treatment with intensive vs standard glucose control for up to 72 hours did not result in a significant difference in favorable functional outcome at 90 days. These findings do not support using intensive glucose control in this setting.
Trial Registration


ClinicalTrials.gov Identifier: NCT01369069.",2019,The primary efficacy outcome was the proportion of patients with a favorable outcome based on the 90-day modified Rankin Scale score (a global stroke disability scale ranging from 0,"['1151 patients who were randomized (mean age, 66 years [SD, 13.1 years]; 529 [46%] women, 920 [80%] with diabetes), 1118 (97%) completed the trial', 'patients with acute ischemic stroke and hyperglycemia', 'Patients With Acute Ischemic Stroke', '1151 patients who met eligibility criteria', 'adult patients with hyperglycemia (glucose concentration of >110 mg/dL if had diabetes or ≥150 mg/dL if did not have diabetes) and acute ischemic stroke who were enrolled within 12 hours from stroke onset at 63 US sites between April 2012 and August 2018; follow-up ended in November 2018']",['continuous intravenous insulin using a computerized decision support tool (target blood glucose concentration of 80-130 mg/dL [4.4-7.2 mmol/L]; intensive treatment group: n\u2009=\u2009581) or insulin on a sliding scale that was administered subcutaneously (target blood glucose concentration of 80-179 mg/dL [4.4-9.9 mmol/L]; standard treatment group: n\u2009=\u2009570) for up to 72 hours'],"['mean blood glucose level', 'Severe hypoglycemia', '90-day modified Rankin Scale score (a global stroke disability scale', 'hypoglycemia or other adverse events', 'favorable functional outcome', 'no symptoms or completely recovered] to 6 [death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517806', 'cui_str': '529 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0240016', 'cui_str': 'Insulin used (attribute)'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1151.0,0.1673,The primary efficacy outcome was the proportion of patients with a favorable outcome based on the 90-day modified Rankin Scale score (a global stroke disability scale ranging from 0,"[{'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnston', 'Affiliation': 'Department of Neurology, University of Virginia, Charlottesville.'}, {'ForeName': 'Askiel', 'Initials': 'A', 'LastName': 'Bruno', 'Affiliation': 'Department of Neurology, Medical College of Georgia, Augusta University, Augusta.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pauls', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Christiana E', 'Initials': 'CE', 'LastName': 'Hall', 'Affiliation': 'Department of Neurology and Neurotherapeutics, UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Barrett', 'Affiliation': 'Department of Neurology, Mayo Clinic Florida, Jacksonville.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Barsan', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Fansler', 'Affiliation': 'Brain Institute, University of Virginia, Charlottesville.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Van de Bruinhorst', 'Affiliation': 'Department of Neurology and Neurotherapeutics, UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Janis', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Durkalski-Mauldin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.9346']
765,32243582,Enhanced serotonin availability amplifies fatigue perception and modulates the TMS-induced silent period during sustained low-intensity elbow flexions.,"KEY POINTS


During maximal effort contractions, intense serotonin release via the raphe-spinal pathway spills over from the somato-dendritic compartment to activate inhibitory 5-HT 1A  receptors on the axon initial segment of motoneurons to reduce motoneuronal output. We investigated whether the same mechanism of central fatigue is present for low-intensity contractions, whereby weak serotonergic drive over an extended period may cause accumulation of serotonin and exacerbate central fatigue. Enhanced availability of serotonin did not directly influence motor pathways or motor performance during prolonged submaximal contraction. However, perceptions of muscle fatigue were greater, and the fatigue-induced lengthening of the silent period elicited via motor cortical stimulation was reduced with enhanced availability of serotonin. We propose that sustained low-intensity serotonergic neurotransmission influences supraspinal processes associated with fatigue, without directly influencing the output of the motor system during submaximal exercise.
ABSTRACT


Enhanced availability of serotonin (5-HT) exacerbates central fatigue that occurs during maximal effort contractions. However, it is unknown if 5-HT release contributes to central fatigue during prolonged submaximal contractions. Hence, we assessed the effect that enhanced availability of 5-HT has on sustained low-intensity fatiguing contractions. Fifteen individuals (22.3 ± 2.1 years) ingested the 5-HT reuptake inhibitor paroxetine in a human, double-blinded, placebo-controlled, repeated-measures design. Participants performed a low-intensity isometric elbow flexion for 30 min (15% of maximal voluntary contraction, MVC). Throughout the protocol, brief MVCs were performed and muscle responses to transcranial magnetic stimulation (TMS) of the motor cortex, electrical stimulation of the brachial plexus, and motor point stimulation of the biceps were obtained. Ratings of perceived fatigue were also acquired. Paroxetine did not influence torque or voluntary activation during brief MVCs performed throughout the low-intensity contraction. However, paroxetine increased the perception of fatigue throughout the contraction (P = 0.005), and shortened the biceps silent period elicited via TMS during sustained submaximal contraction (P = 0.003) and brief MVCs (P = 0.011). Overall, it appears that prolonged low-intensity contractions do not cause intense 5-HT release onto motoneurons, and therefore, 5-HT does not activate inhibitory extra-synaptic 5-HT 1A  receptors of motoneurons to reduce their output. Although motor performance was unaffected by paroxetine, perceived fatigue was greater and intracortical inhibitory activity was reduced following the enhancement of endogenous concentrations of 5-HT during sustained submaximal contraction. Thus, 5-HT affects supraspinal processes during low-intensity contractions without directly altering motor pathways projecting to the muscle.",2020,"Although motor performance was unaffected by paroxetine, perceived fatigue was greater and intracortical inhibitory activity was reduced following the enhancement of endogenous concentrations of 5-HT during sustained submaximal contraction.",['Fifteen individuals (22.3\xa0±\xa02.1\xa0yr) ingested the'],"['low-intensity isometric elbow flexion', 'serotonin (5-HT', 'Paroxetine', 'paroxetine', 'serotonin', '5-HT', '5-HT reuptake inhibitor paroxetine']","['perception of fatigue', 'Ratings of perceived fatigue', 'brief MVCs', 'muscle fatigue', 'intracortical inhibitory activity', 'torque or voluntary activation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}]",,0.04441,"Although motor performance was unaffected by paroxetine, perceived fatigue was greater and intracortical inhibitory activity was reduced following the enhancement of endogenous concentrations of 5-HT during sustained submaximal contraction.","[{'ForeName': 'Jacob R', 'Initials': 'JR', 'LastName': 'Thorstensen', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Murray G', 'Initials': 'MG', 'LastName': 'Tucker', 'Affiliation': 'Mental Health, Drugs and Alcohol Service, Barwon Health, University Hospital Geelong, Geelong, Victoria, Australia.'}, {'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Kavanagh', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}]",The Journal of physiology,['10.1113/JP279347']
766,32061969,Athletes for life: Rationale and methodology of a community- and family-based randomized controlled trial to promote cardiovascular fitness among primarily Latino families.,"BACKGROUND


Community-based programs have had modest success in combating obesity in Latino populations. Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs. Because improvements in cardiorespiratory fitness confer health benefits, regardless of weight, they offer an alternative to obesity-focused approaches. We describe the rationale and design of Athletes for Life (AFL), a community- and family-based intervention for Latino families.
METHODS/DESIGN


This two-group randomized controlled trial will test the efficacy of AFL for improving cardiorespiratory fitness and diet in 6- to 11-year-old children (N = 160) and their parents, relative to a wait-list control group. Children will participate in 12 weeks of semiweekly sports skill programing and nutrition sessions. Concurrently, parents will participate in sports-focused activity and behavior change sessions that focus on nutrition, chronic disease prevention, and healthy eating. Cardiovascular fitness will be measured by the 1-mile run and 3-min step-test for both parents and children. Secondary outcomes include changes in objectively measured physical activity, dietary measures, body composition, and cardiometabolic risk (waist circumference, blood pressure, blood lipids, glucose, insulin, and C-reactive protein).
DISCUSSION


AFL, implemented with a strong community partnership, will provide a test of the efficacy of culturally tailored intervention programming to promote positive health behaviors and improve health outcomes in Latino families. Intervention content, structure, and messaging will provide guidance for future methods to engage Latino families in health promotion programs that highlight their cultural norms, and beliefs.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier NCT03761589 (12/3/2018).",2020,"Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs.","['Latino families', '6- to 11-year-old children (N\u202f=\u202f160) and their parents, relative to a wait-list control group', 'Latino populations', 'Athletes for Life (AFL), a community- and family-based intervention for Latino families', 'primarily Latino families']","['semiweekly sports skill programing and nutrition sessions', 'AFL']","['changes in objectively measured physical activity, dietary measures, body composition, and cardiometabolic risk (waist circumference, blood pressure, blood lipids, glucose, insulin, and C-reactive protein', 'cardiorespiratory fitness and diet', 'health outcomes', 'Cardiovascular fitness']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.040074,"Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Szeszulski', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; The University of Texas Health Science Center at Houston, Center for Health Promotion and Prevention Research, 7000 Fannin Street, #1200, Houston, TX 77030, USA; The University of Texas Health Science Center at Houston, Austin Campus, Michael Susan Dell Center for Healthy Living, 1616 Guadalupe Street, Suite 6.300, Austin, TX 78701, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vega-López', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; Arizona State University, Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service & Community Solutions, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'Arizona State University, Edson College of Nursing and Health Innovation, 550 North 3rd Street, Suite 301, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ray', 'Affiliation': 'City of Phoenix Parks and Recreation, 212 East Alta Vista Rd, Phoenix, AZ 85042, USA.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Behar', 'Affiliation': 'San Diego State University, School of Public Health, 5500 Campanile Drive, San Diego, CA 92182, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chavez', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Eckert', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; Mays Cancer Center at UT Health San Antonio MD Anderson, 7979 Wurzbach Rd, San Antonio, TX 78229, USA.'}, {'ForeName': 'Anabell', 'Initials': 'A', 'LastName': 'Lorenzo-Quintero', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Hartmann Manrique', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Noe C', 'Initials': 'NC', 'LastName': 'Crespo', 'Affiliation': 'San Diego State University, School of Public Health, 5500 Campanile Drive, San Diego, CA 92182, USA. Electronic address: ncrespo@sdsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105956']
767,32032641,Birth Control Connect: A randomized trial of an online group to disseminate contraceptive information.,"OBJECTIVE


We sought to test whether participation in an online group including IUD users influenced IUD-related knowledge, attitudes, and behavior among IUD non-users, as a proof-of-concept evaluation of information dissemination for less commonly used or novel contraceptives.
STUDY DESIGN


We conducted a blinded, randomized controlled trial on the effect of online communication with IUD users within an online program called Birth Control Connect. Participants were women age 18-45 living in the United States who had never used an IUD. We invited participants randomized to the intervention to join two-week, nine-member discussion groups including four satisfied IUD users and five IUD non-users; we invited control participants to groups including nine IUD non-users. We performed chi-squared tests on IUD knowledge, information-seeking, informational support and use in immediate post-surveys, and t-tests comparing change in IUD attitudes and frequency of logins to discussion groups.
RESULTS


We invited 488 IUD non-users and enrolled them into 70 groups between October 2015 and April 2016. We found increased positive attitudes towards the IUD in the intervention arm (0.65-point increase between pre- and post-surveys, versus 0.05 mean change for control arm, p = 0.03 for hormonal IUD, with a trend in the same direction for the non-hormonal IUD). Informational support also increased, with 70.3% of intervention arm participants self-reporting that they gained a better idea of what the IUD would be like, compared to 51.3% in control arm (p < 0.01). Of intervention participants, 63.3% versus 51.3% of control participants reported gaining new information from their group (p = 0.03). There were no differences in correct responses to knowledge items or information-seeking between groups.
CONCLUSIONS


Online exposure to IUD users increased positive attitudes toward the IUD and informational support for decision-making about the IUD among non-users.
IMPLICATIONS STATEMENT


Online spaces provide a promising environment for the exchange of accurate, useful contraceptive information based on real user experiences. Interventions aiming to harness social communication through structured online conversations (e.g., on existing social media platforms) about user experiences with lesser-known contraceptive methods such as the IUD may be worthwhile.",2020,"Of intervention participants, 63.3% versus 51.3% of control participants reported gaining new information from their group (p=0.03).","['Participants were women age 18-45 living in the United States who had never used an IUD', '488 IUD non-users and enrolled them into 70 groups between October 2015 and April 2016']",['nine-member discussion groups including four satisfied IUD users and five IUD non-users; we invited control participants to groups including nine IUD non-users'],"['gaining new information', 'correct responses to knowledge items or information-seeking', 'positive attitudes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205455', 'cui_str': '9'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}]",488.0,0.257525,"Of intervention participants, 63.3% versus 51.3% of control participants reported gaining new information from their group (p=0.03).","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dehlendorf', 'Affiliation': 'University of California, San Francisco, Department of Family & Community Medicine, Person-Centered Reproductive Health Program, 1001 Potrero Ave., San Francisco, CA 94110, USA; University of California, San Francisco, Department of Obstetrics, Gynecology, & Reproductive Sciences, 1001 Potrero Ave., San Francisco, CA 94110, USA; University of California, San Francisco, Department of Epidemiology and Biostatistics, 1001 Potrero Ave., San Francisco, CA 94110, USA. Electronic address: christine.dehlendorf@ucsf.edu.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fox', 'Affiliation': 'University of California, San Francisco, Department of Family & Community Medicine, Person-Centered Reproductive Health Program, 1001 Potrero Ave., San Francisco, CA 94110, USA. Electronic address: edith.fox@ucsf.edu.'}, {'ForeName': 'Anjana E', 'Initials': 'AE', 'LastName': 'Sharma', 'Affiliation': 'University of California, San Francisco, Department of Family & Community Medicine, Person-Centered Reproductive Health Program, 1001 Potrero Ave., San Francisco, CA 94110, USA. Electronic address: anjana.sharma@ucsf.edu.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'University of Pennsylvania, Annenberg School for Communication, Network Dynamics Group, 3620 Walnut Street, Philadelphia, PA 19104, USA; University of California, Davis, Department of Communication, One Shields Avenue, Davis, CA 95616, USA. Electronic address: jwzzhang@ucdavis.edu.'}, {'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'University of Pennsylvania, Annenberg School for Communication, Network Dynamics Group, 3620 Walnut Street, Philadelphia, PA 19104, USA. Electronic address: sijia.yang@asc.penn.edu.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Centola', 'Affiliation': 'University of Pennsylvania, Annenberg School for Communication, Network Dynamics Group, 3620 Walnut Street, Philadelphia, PA 19104, USA. Electronic address: dcentola@asc.penn.edu.'}]",Contraception,['10.1016/j.contraception.2020.01.014']
768,32037592,A randomized controlled trial of a physiology-guided percutaneous coronary intervention optimization strategy: Rationale and design of the TARGET FFR study.,"Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) ≥0.90 confers an improved cardiac prognosis. There are currently limited data available to determine how often it is possible to improve an angiographically acceptable but physiologically suboptimal result. A physiology-guided optimization strategy can achieve a clinically meaningful increase in the proportion of patients achieving a final post-PCI FFR ≥0.90 compared to standard care. Following angiographically successful PCI procedures, 260 patients will be randomized (1:1) to receive either a physiology-guided incremental optimization strategy (intervention group) or blinded post-PCI coronary physiology measurements (control group). Patients undergoing successful, standard-of-care PCI for either stable angina or non-ST-segment-elevation myocardial infarction who meet the study's inclusion and exclusion criteria will be eligible for randomization. The primary endpoint is defined as the proportion of patients with a final post-PCI FFR result ≥0.90. Secondary endpoints include change from baseline in Seattle Angina Questionnaire and EQ-5D-5L scores at 3 months and the rate of target vessel failure and its components (cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalization with target vessel revascularization) at 3 months and 1 year. 260 individual patients were successfully randomized between March 2018 and November 2019. Key baseline demographics of the study population are reported within. TARGET FFR is an investigator-initiated, prospective, single-center, randomized controlled trial of an FFR-guided PCI optimization strategy. The study has completed recruitment and is now in clinical follow-up. It is anticipated that primary results will be presented in Autumn 2020. ClinicalTrials.gov Identifier: NCT03259815. [Correction added on Apr 3 2020, after first online publication: Clinical Trials identifier added.].",2020,Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) ≥0.90 confers an improved cardiac prognosis.,"['260 patients', ""Patients undergoing successful, standard-of-care PCI for either stable angina or non-ST-segment-elevation myocardial infarction who meet the study's inclusion and exclusion criteria will be eligible for randomization"", '260 individual patients were successfully randomized between March 2018 and November 2019']","['physiology-guided percutaneous coronary intervention', 'FFR', 'physiology-guided incremental optimization strategy (intervention group) or blinded post-PCI coronary physiology measurements (control group']","['proportion of patients with a final post-PCI FFR result ≥0.90', 'change from baseline in Seattle Angina Questionnaire and EQ-5D-5L scores at 3 months and the rate of target vessel failure and its components (cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalization with target vessel revascularization']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",260.0,0.129999,Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) ≥0.90 confers an improved cardiac prognosis.,"[{'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Collison', 'Affiliation': 'West of Scotland Regional Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'McClure', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'West of Scotland Regional Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'West of Scotland Regional Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.'}]",Clinical cardiology,['10.1002/clc.23342']
769,32241047,[Clinical effects of concentrated growth factor combined with plasma albumin gel in treating facial depressed scar].,"Objective:  To explore the clinical effects of concentrated growth factor (CGF) combined with plasma albumin gel (PAG) in treating facial depressed scar.  Methods:  From January 2018 to June 2019, 14 patients in the First Affiliated Hospital of Zhengzhou University and 10 patients in Henan NO.3 Provincial People's Hospital with facial depressed scar who met the inclusion criteria were admitted, and their clinical data were retrospectively analyzed by the method of case-control study. Based on the method of treatment, 8 patients (4 males and 4 females) aged 28.50 (25.50, 31.50) years were enrolled in CGF alone group, 8 patients (3 males and 5 females) aged 32.00 (28.50, 35.00) years were enrolled in PAG alone group, and 8 patients (5 males and 3 females) aged 33.50 (29.00, 35.75) years were enrolled in CGF+ PAG group. Suitable amount of CGF, PAG, and CGF+ PAG (mixed at a ratio of 1.0∶1.0-1.0∶1.5) prepared from autologous blood were injected subcutaneously via a single or multiple entrance (s) into the depressed scar of patients in CGF alone, PAG alone, and CGF+ PAG groups respectively to fill up the concavity, once every 4 weeks for a total of 3 times. Before the first treatment (hereinafter referred to as before treatment) and 3 months after the last treatment (hereinafter referred to as after treatment), the Goodman & Baron Acne Scar Grading System was used for scar grading, and the difference was calculated; the Anxiety Self-Rating Scale was used to score anxiety, and the difference was calculated. The Visual Analogue Score was used to score pain immediately after the first treatment. By one, two, and three months after treatment, the patients' satisfaction to scar treatment was scored, and the Global Aesthetic Improvement Scale was used to score the scar improvement. Adverse reaction of patients after treatment was monitored. Data were statistically analyzed with Fisher's exact probability test, Kruskal-Wallis  H  test, Mann-Whitney  U  test, Bonferroni correction, and Wilcoxon signed rank sum test.  Results:  (1) The scars of patients in the three groups were all graded 4.00 (4.00, 4.00) before treatment ( χ (2)<0.001,  P >0.05). By three months after treatment, compared with 2.00 (1.25, 2.00) of CGF alone group, the scar grades of patients in PAG alone group and CGF+ PAG group (3.00 (2.00, 3.00) and 1.00 (1.00, 1.00), respectively) had no significant change ( Z =2.199, 2.003,  P >0.05). The scar grade of patients in CGF+ PAG group was significantly lower than that in PAG alone group ( Z =3.229,  P <0.01). Compared with those before treatment, the scar grades of patients in CGF alone group, PAG alone group, and CGF+ PAG group were significantly reduced three months after treatment ( Z =2.588, 2.598, 2.640,  P <0.05 or  P <0.01). The difference in scar grade before and after the treatment was significantly higher in CGF+ PAG group than in PAG alone group ( Z =3.229,  P <0.01). (2) The anxiety scores of patients in the three groups were similar before treatment and 3 months after ( χ (2)=2.551, 2.768,  P >0.05). Compared with those before treatment, the anxiety scores of patients in CGF alone group, PAG alone group, and CGF+ PAG group were significantly reduced three months after treatment ( Z =2.395, 2.527, 2.533,  P <0.05). The differences in anxiety score before and after the treatment were similar among the three groups ( χ (2)=1.796,  P >0.05). (3) The pain scores of patients in the three groups were similar immediately after the first treatment ( χ (2)=0.400,  P >0.05). (4) By one and two month (s) after treatment, the patients' satisfaction scores to scar treatment in the three groups were similar ( χ (2)=2.688, 5.989,  P >0.05). By three months after treatment, the patients' satisfaction score to scar treatment in CGF+ PAG group was significantly higher than that in PAG alone group ( Z =2.922,  P <0.01). Compared with those one month after treatment within the same group, the patients' satisfaction scores to scar treatment in CGF alone group, PAG alone group, and CGF+ PAG group were significantly increased two and three months after treatment ( Z =1.121, 2.392, 2.000, 2.828, 2.449, 2.598,  P <0.05 or  P <0.01). Compared with those two months after treatment within the same group, the patients' satisfaction scores to scar treatment in CGF alone group, PAG alone group, and CGF+ PAG group were significantly increased three months after treatment ( Z =2.271, 2.000, 2.646,  P <0.05 or  P <0.01). (5) One month after treatment, the scar improvement scores of patients in the three groups were similar ( χ (2)=4.438,  P >0.05). Two months after treatment, the scar improvement scores of patients in CGF alone group and CGF+ PAG group were 2.00 (2.00, 2.75) and 2.00 (2.00, 2.00) points, respectively, which were significantly higher than 1.00 (1.00, 1.00) point of PAG alone group ( Z =3.303, 3.771,  P <0.01). Three months after treatment, the scar improvement score of patients in CGF+ PAG group was 3.00 (3.00, 3.00) points, which was significantly higher than 2.00 (2.00, 2.75) points of CGF alone group and 1.00 (1.00, 2.00) points of PAG alone group ( Z =2.450, 3.427,  P <0.05 or  P <0.01). Compared with those one month after treatment within the same group, the scar improvement scores of patients were significantly higher in CGF alone group and CGF+ PAG group two and three months after treatment and in PAG alone group three months after treatment ( Z =2.828, 2.828, 2.530, 2.640, 2.121,  P <0.05 or  P <0.01). Compared with that two months after treatment within the same group, the scar improvement score of patients in CGF+ PAG group was significantly higher three months after treatment ( Z =2.449,  P <0.05). (6) After injection, all patients in the three groups had slight redness and swelling at the needle prick point and no other adverse reactions.  Conclusions:  CGF combined with PAG can reduce the scar grading, anxiety of patients, and enhance patients' satisfaction and scar improvement in the treatment of patients with facial depressed scar. The combined CGF+ PAG injection, without significant adverse reactions, is better than single component injection and is worthy of clinical application.",2020,"The difference in scar grade before and after the treatment was significantly higher in CGF+ PAG group than in PAG alone group ( Z =3.229,  P <0.01).","['8 patients (4 males and 4 females) aged 28.50 (25.50, 31.50) years were enrolled in CGF alone group, 8 patients (3 males and 5 females) aged 32.00 (28.50, 35.00) years were enrolled in PAG alone group, and 8 patients (5 males and 3 females) aged 33.50 (29.00, 35.75) years were enrolled in CGF+ PAG group', 'treating facial depressed scar', 'patients with facial depressed scar', ""From January 2018 to June 2019, 14 patients in the First Affiliated Hospital of Zhengzhou University and 10 patients in Henan NO.3 Provincial People's Hospital with facial depressed scar who met the inclusion criteria were admitted, and their clinical data were retrospectively analyzed by the method of case-control study""]","['concentrated growth factor (CGF) combined with plasma albumin gel (PAG', 'CGF+ PAG', 'CGF combined with PAG', 'concentrated growth factor combined with plasma albumin gel', 'CGF alone, PAG alone, and CGF+ PAG', 'CGF']","['scar grades', 'pain scores', 'slight redness and swelling', 'satisfaction score to scar treatment', 'satisfaction scores to scar treatment', 'anxiety scores', 'scar improvement scores', 'scar grade', ""Fisher's exact probability test, Kruskal-Wallis  H  test, Mann-Whitney  U  test, Bonferroni correction, and Wilcoxon signed rank sum test"", 'Adverse reaction', 'scar improvement score', 'Global Aesthetic Improvement Scale', 'Anxiety Self-Rating Scale', 'anxiety score', 'adverse reactions', 'Visual Analogue Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0432284', 'cui_str': 'Infantile myofibromatosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0228398', 'cui_str': 'Structure of periaqueductal gray matter'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}]","[{'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0857876', 'cui_str': 'Plasma albumin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0228398', 'cui_str': 'Structure of periaqueductal gray matter'}, {'cui': 'C0432284', 'cui_str': 'Infantile myofibromatosis'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C2937276', 'cui_str': 'Slight'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0242928', 'cui_str': 'Rank-Sum Tests'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",,0.0168518,"The difference in scar grade before and after the treatment was significantly higher in CGF+ PAG group than in PAG alone group ( Z =3.229,  P <0.01).","[{'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Sun', 'Affiliation': 'Department of Burns and Repair Reconstruction, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': ""Department of Plastic Surgery, Henan NO.3 Provincial People's Hospital, Zhengzhou 450000, China.""}, {'ForeName': 'Z J', 'Initials': 'ZJ', 'LastName': 'Cui', 'Affiliation': 'Department of Burns and Repair Reconstruction, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China.'}, {'ForeName': 'Q N', 'Initials': 'QN', 'LastName': 'Meng', 'Affiliation': 'Department of Burns and Repair Reconstruction, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China.'}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Liu', 'Affiliation': 'Department of Burns and Repair Reconstruction, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Burns and Repair Reconstruction, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China.'}, {'ForeName': 'Z G', 'Initials': 'ZG', 'LastName': 'Yu', 'Affiliation': 'Department of Burns and Repair Reconstruction, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China.'}]",Zhonghua shao shang za zhi = Zhonghua shaoshang zazhi = Chinese journal of burns,['10.3760/cma.j.cn501120-20190930-00389']
770,32237279,"A new model of care and in-house general practitioners for residential aged care facilities: a stepped wedge, cluster randomised trial.","OBJECTIVES


To evaluate whether an alternative model of care in aged care facilities, including in-house general practitioners, influenced health outcomes for residents.
DESIGN


Stepped wedge, cluster randomised controlled trial over 90 weeks (31 December 2012 - 21 September 2014), with a 54-week pre-trial retrospective data period (start: 19 December 2011) and a 54-week post-trial prospective data collection period (to 4 October 2015).
PARTICIPANTS, SETTING


Fifteen residential aged care facilities operated by Bupa Aged Care in metropolitan and regional cities in four Australian states.
INTERVENTION


Residential aged care facilities sought to recruit general practitioners as staff members; care staff roles were redefined to allow registered nurses greater involvement in care plan development.
MAIN (PRIMARY) OUTCOME MEASURES


Numbers of falls; numbers of unplanned transfers to hospital; polypharmacy.
RESULTS


The new model of care could be implemented in all facilities, but four could not recruit in-house GPs at any time during the trial period. Intention-to-treat analyses found no statistically significant effect of the intervention on the primary outcome measures. Contamination-adjusted intention-to-treat analyses identified that the presence of an in-house GP was associated with reductions in the numbers of unplanned hospital transfers (incidence rate ratio [IRR], 0.53; 95% CI, 0.43-0.66) and admissions (IRR, 0.52; 95% CI, 0.41-0.64) and of out-of-hours GP call-outs (IRR, 0.54; 95% CI, 0.36-0.80), but also with an increase in the number of reported falls (IRR, 1.37; 95% CI, 1.20-1.58).
CONCLUSIONS


Recruiting GPs to work directly in residential aged care facilities is difficult, but may reduce the burden of unplanned presentations to hospitals and increase the reporting of adverse events.
TRIAL REGISTRATION


Australia New Zealand Clinical Trial Registry, ACTRN12613000218796 (25 February 2013).",2020,"Contamination-adjusted intention-to-treat analyses identified that the presence of an in-house GP was associated with reductions in the numbers of unplanned hospital transfers (incidence rate ratio [IRR], 0.53; 95% CI, 0.43-0.66) and admissions (IRR, 0.52; 95% CI, 0.41-0.64) and of out-of-hours GP call-outs (IRR, 0.54; 95% CI, 0.36-0.80), but also with an increase in the number of reported falls (IRR, 1.37; 95% CI, 1.20-1.58).
","['90 weeks (31 December 2012 - 21 September 2014), with a 54-week pre-trial retrospective data period (start: 19 December 2011) and a 54-week post-trial prospective data collection period (to 4 October 2015', 'Fifteen residential aged care facilities operated by Bupa Aged Care in metropolitan and regional cities in four Australian states', 'residential aged care facilities', 'house general practitioners for residential aged care facilities', 'aged care facilities, including in-house general practitioners, influenced health outcomes for residents']",['Residential aged care facilities sought to recruit general practitioners as staff members; care staff roles were redefined to allow registered nurses greater involvement in care plan development'],"['Numbers of falls; numbers of unplanned transfers to hospital; polypharmacy', 'numbers of unplanned hospital transfers']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}]",,0.299138,"Contamination-adjusted intention-to-treat analyses identified that the presence of an in-house GP was associated with reductions in the numbers of unplanned hospital transfers (incidence rate ratio [IRR], 0.53; 95% CI, 0.43-0.66) and admissions (IRR, 0.52; 95% CI, 0.41-0.64) and of out-of-hours GP call-outs (IRR, 0.54; 95% CI, 0.36-0.80), but also with an increase in the number of reported falls (IRR, 1.37; 95% CI, 1.20-1.58).
","[{'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Haines', 'Affiliation': 'Monash University, Melbourne, VIC.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Palmer', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Tierney', 'Affiliation': 'Bupa Aged Care Australia, Sydney, NSW.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Si', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Robinson', 'Affiliation': 'Wicking Dementia Research and Education Centre, University of Tasmania, Hobart, TAS.'}]",The Medical journal of Australia,['10.5694/mja2.50565']
771,32087339,"Treatment for anxiety: Mindfulness meditation versus escitalopram (TAME): Design of a randomized, controlled non-inferiority trial.","Anxiety disorders (generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia) are common, distressing, and impairing. While pharmacotherapy and psychotherapy are first-line treatment strategies for anxiety disorders, many patients are reluctant to take psychiatric medication, and many prefer to avoid any kind of mental health treatment due to stigma or distrust of traditional medical care. We present the trial protocol for the first study comparing first-line medication treatment with Mindfulness-Based Stress Reduction (MBSR), a popular mindfulness meditation training program, for the treatment of anxiety disorders. We will use a non-inferiority, comparative effectiveness trial design, in which individuals with diagnosed anxiety disorders will be randomized to either pharmacotherapy with escitalopram or MBSR for 8 weeks of treatment. Treatment outcome will be based on gold standard symptom severity measures assessed by trained independent evaluators blind to treatment allocation. Secondary outcomes will include key symptom and function measures, as well as tolerability and satisfaction with treatment. Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders.",2020,"Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders.","['anxiety disorders', 'individuals with diagnosed anxiety disorders']","['Mindfulness-Based Stress Reduction (MBSR), a popular mindfulness meditation training program', 'anxiety: Mindfulness meditation versus escitalopram (TAME', 'pharmacotherapy with escitalopram or MBSR']","['Anxiety disorders (generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia', 'key symptom and function measures, as well as tolerability and satisfaction with treatment']","[{'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0150277'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0287433,"Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hoge', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA. Electronic address: eah103@georgetown.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bui', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mihriye', 'Initials': 'M', 'LastName': 'Mete', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA; MedStar Health Research Institute, Hyattsville, MD, USA.'}, {'ForeName': 'Samantha R', 'Initials': 'SR', 'LastName': 'Philip', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gabriel', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA.'}, {'ForeName': 'Meredith J', 'Initials': 'MJ', 'LastName': 'Ward', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Suzuki', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Dutton', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, New York University School of Medicine, New York, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105965']
772,31118485,Improving medication adherence in adult kidney transplantation (IMAKT): A pilot randomised controlled trial.,"Resources to support long-term medication adherence in kidney transplantation are limited. This study aimed to determine the efficacy of an intervention designed for kidney transplant recipients to enhance medication adherence. A single-blind, multi-site, 12-month pilot randomised controlled trial was conducted at all five public hospitals providing adult kidney transplantation in Victoria, Australia. Participants were recruited at 4 to 6 weeks post-transplantation. Thirty-five participants were randomly assigned to a 3-month intervention, involving a face-to-face meeting (a medication review and a consumer-centred video) and health coaching every two weeks. Thirty-six were randomised to receive usual care. All participants were followed for nine months post-intervention. There were no differences in adherence between groups measured by Medication Event Monitoring System (MEMS), however, it was underutilised by 42% of participants. Based on the self-reported Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS©) score, the percentage of adherent participants decreased significantly between baseline and 3 to 12 months in the control group (p-values < 0.001) whilst the percentage of adherent participants in the intervention group remained constant over time. No group differences were detected in other outcomes. Due to the complex medication regimen, developing and testing a medication adherence intervention is difficult in kidney transplantation.",2019,"There were no differences in adherence between groups measured by Medication Event Monitoring System (MEMS), however, it was underutilised by 42% of participants.","['five public hospitals providing adult kidney transplantation in Victoria, Australia', 'Thirty-six', 'adult kidney transplantation (IMAKT', 'Thirty-five participants', 'kidney transplant recipients']",[],"['adherence', 'Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS©) score']","[{'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}]",[],"[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",35.0,0.0694951,"There were no differences in adherence between groups measured by Medication Event Monitoring System (MEMS), however, it was underutilised by 42% of participants.","[{'ForeName': 'Jac Kee', 'Initials': 'JK', 'LastName': 'Low', 'Affiliation': 'Monash Nursing & Midwifery, Monash University, Clayton, Victoria, Australia. jackee.low@gmail.com.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Manias', 'Affiliation': 'School of Nursing and Midwifery, Centre for Quality and Patient Safety Research, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Crawford', 'Affiliation': 'Monash Nursing & Midwifery, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Department of Renal Medicine, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Mulley', 'Affiliation': 'Department of Nephrology, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Nigel D', 'Initials': 'ND', 'LastName': 'Toussaint', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dooley', 'Affiliation': 'Alfred Health, Prahran, Victoria, Australia.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Kennedy', 'Affiliation': 'Department of Nephrology, Monash Medical Centre, Clayton, Victoria, Australia.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Smith', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Nalder', 'Affiliation': 'Pharmacy Department, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Yip', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Monash Nursing & Midwifery, Monash University, Clayton, Victoria, Australia.'}]",Scientific reports,['10.1038/s41598-019-44002-y']
773,31127163,"Effects of a moderate-to-high intensity resistance circuit training on fat mass, functional capacity, muscular strength, and quality of life in elderly: A randomized controlled trial.","Physical exercise is considered an important intervention for promoting well-being and healthy aging. The objective was to determine the effects of moderate-to-high intensity resistance circuit training on different parameters of body composition, functional autonomy, muscular strength and quality of life in elderly. A randomized controlled trial was conducted. A total of 45 subjects (27 females, 18 males) aged between 65-75 years old from Murcia (Spain) were divided by sex, and randomly to experimental group (n = 33, mean age 69 ± 3.2 years old) receiving 12 weeks of moderate-to-high intensity resistance circuit training and control group (n = 33, mean age 70 ± 4.1 years old) receiving no exercise intervention. Intra-group comparison, the experimental group showed a significant increment of lean body mass in women and men, which also presented a decrease of fat mass. Both sex presented a significant improve in functional autonomy, and significately higher values of muscular strength. But no changes were observed regarding quality of life in these groups. The control group did not show any differences pre and post-intervention in women, but in men presented an increment of body mass index and total weight post-intervention. No changes were showed in the other variables. Similar results were founded at inter-group comparison. The moderate-to-high intensity resistance circuit training showed increase in total lean body mass, improvements in functional capacity and significantly increase in upper and lower muscular strength in women and men. Progressive resistance circuit training should be promoted for the elderly as it has the potential to improve physical performance, thereby prolonging healthy independent aging.",2019,"The moderate-to-high intensity resistance circuit training showed increase in total lean body mass, improvements in functional capacity and significantly increase in upper and lower muscular strength in women and men.","['elderly', '45 subjects (27 females, 18 males) aged between 65-75 years old from Murcia (Spain) were divided by sex, and randomly to experimental group (n\u2009=\u200933, mean age 69\u2009±\u20093.2 years old) receiving 12 weeks of']","['moderate-to-high intensity resistance circuit training', 'Progressive resistance circuit training', 'moderate-to-high intensity resistance circuit training and control group (n\u2009=\u200933, mean age 70\u2009±\u20094.1 years old) receiving no exercise intervention', 'Physical exercise']","['functional autonomy', 'body composition, functional autonomy, muscular strength and quality of life', 'muscular strength', 'body mass index and total weight post-intervention', 'fat mass', 'fat mass, functional capacity, muscular strength, and quality of life', 'quality of life', 'total lean body mass, improvements in functional capacity', 'lean body mass']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}]",45.0,0.0181237,"The moderate-to-high intensity resistance circuit training showed increase in total lean body mass, improvements in functional capacity and significantly increase in upper and lower muscular strength in women and men.","[{'ForeName': 'Pablo Jorge', 'Initials': 'PJ', 'LastName': 'Marcos-Pardo', 'Affiliation': 'Grupo de Investigación en Salud, Actividad Física, Fitness y Comportamiento Motor (GISAFFCOM), Faculty of Sport, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain. pmarcos@ucam.edu.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Orquin-Castrillón', 'Affiliation': 'Grupo de Investigación en Salud, Actividad Física, Fitness y Comportamiento Motor (GISAFFCOM), Faculty of Sport, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Gemma María', 'Initials': 'GM', 'LastName': 'Gea-García', 'Affiliation': 'Grupo de Investigación en Salud, Actividad Física, Fitness y Comportamiento Motor (GISAFFCOM), Faculty of Sport, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Ruperto', 'Initials': 'R', 'LastName': 'Menayo-Antúnez', 'Affiliation': 'Grupo de Investigación en Salud, Actividad Física, Fitness y Comportamiento Motor (GISAFFCOM), Faculty of Sport, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'González-Gálvez', 'Affiliation': 'Grupo de Investigación en Salud, Actividad Física, Fitness y Comportamiento Motor (GISAFFCOM), Faculty of Sport, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Rodrigo Gomes de Souza', 'Initials': 'RGS', 'LastName': 'Vale', 'Affiliation': 'Grupo de Investigación en Salud, Actividad Física, Fitness y Comportamiento Motor (GISAFFCOM), Faculty of Sport, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martínez-Rodríguez', 'Affiliation': 'Grupo de Investigación en Salud, Actividad Física, Fitness y Comportamiento Motor (GISAFFCOM), Faculty of Sport, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain.'}]",Scientific reports,['10.1038/s41598-019-44329-6']
774,31741204,Quality of life outcomes of web-based and in-person weight management for adults with serious mental illness.,"Adults with serious mental illness have high rates of obesity, with associated negative impacts on health-related quality of life. The present study utilized data from a randomized controlled trial (N = 276) to examine the effectiveness of in-person and online-delivered weight management interventions, compared to usual care, for improving health-related quality of life in this population. Participants completed quality of life assessments at baseline, 3 months, and 6 months. Mixed effects models examined group by time interactions. Compared to usual care, in-person MOVE was associated with improvements in loneliness (t = - 2.76, p = .006) and mental health related quality of life (t = 1.99, p = 0.048) at 6 months, and webMOVE was associated with improvements in weight-related self-esteem at 6 months (t = 2.23, p = .026) and mental health-related quality of life at 3 months (t = 2.17, p = 0.031) and 6 months (t = 2.38, p = .018). Web-based and in-person weight management led to improvements in health-related quality of life for adults with serious mental illness.ClinicalTrials.gov Identifier: NCT00983476.",2019,"Compared to usual care, in-person MOVE was associated with improvements in loneliness (t = - 2.76, p = .006) and mental health related quality of life (t = 1.99, p = 0.048) at 6 months, and webMOVE was associated with improvements in weight-related self-esteem at 6 months (t = 2.23, p = .026) and mental health-related quality of life at 3 months (t = 2.17, p = 0.031) and 6 months (t = 2.38, p = .018).","['adults with serious mental illness', 'Adults with serious mental illness']","['person and online-delivered weight management interventions', 'web-based and in-person weight management']","['mental health related quality of life', 'quality of life assessments', 'health-related quality of life', 'mental health-related quality of life', 'weight-related self-esteem', 'loneliness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0023974', 'cui_str': 'Loneliness'}]",276.0,0.177496,"Compared to usual care, in-person MOVE was associated with improvements in loneliness (t = - 2.76, p = .006) and mental health related quality of life (t = 1.99, p = 0.048) at 6 months, and webMOVE was associated with improvements in weight-related self-esteem at 6 months (t = 2.23, p = .026) and mental health-related quality of life at 3 months (t = 2.17, p = 0.031) and 6 months (t = 2.38, p = .018).","[{'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Muralidharan', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA. anjana.muralidharan2@va.gov.'}, {'ForeName': 'Clayton H', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of Psychiatric Services Research, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Noosha', 'Initials': 'N', 'LastName': 'Niv', 'Affiliation': 'Veterans Affairs Desert Pacific Mental Illness Research, Education, and Clinical Center (MIRECC), Long Beach, CA, USA.'}, {'ForeName': 'Amy N', 'Initials': 'AN', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kreyenbuhl', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Oberman', 'Affiliation': 'VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Goldberg', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Young', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00117-1']
775,32240832,Antibiotics Do Not Reduce Length of Hospital Stay for Uncomplicated Diverticulitis in a Pragmatic Double-Blind Randomized Trial.,"BACKGROUND & AIMS


Antibiotic treatment is the standard care for patients with uncomplicated acute diverticulitis. However, this practice is based on low-level evidence and has been challenged by findings from 2 randomized trials, which did not include a placebo group. We investigated the non-inferiority of placebo vs antibiotic treatment for the management of uncomplicated acute diverticulitis.
METHODS


In the selective treatment with antibiotics for non-complicated diverticulitis study, 180 patients hospitalized for uncomplicated acute diverticulitis (determined by computed tomography, Hinchey 1a grade) from New Zealand and Australia were randomly assigned to groups given antibiotics (n = 85) or placebo (n = 95) for 7 days. We collected demographic, clinical, and laboratory data and answers to questionnaires completed every 12 hrs for the first 48 hrs and then daily until hospital discharge. The primary endpoint was length of hospital stay; secondary endpoints included occurrence of adverse events, readmission to the hospital, procedural intervention, change in serum markers of inflammation, and patient-reported pain scores at 12 and 24 hrs.
RESULTS


There was no significant difference in median time of hospital stay between the antibiotic group (40.0 hrs; 95% CI, 24.4-57.6 hrs) and the placebo group (45.8 hrs; 95% CI, 26.5-60.2 hrs) (P = .2). There were no significant differences between groups in adverse events (12% for both groups; P = 1.0), readmission to the hospital within 1 week (6% for the placebo group vs 1% for the antibiotic group; P = .1), and readmission to the hospital within 30 days (6% for the placebo group vs 11% for the antibiotic group; P = .3).
CONCLUSIONS


Foregoing antibiotic treatment did not prolong length of hospital admission. This result provides strong evidence for omission of antibiotics for selected patients with uncomplicated acute diverticulitis.
ACTRN


12615000249550.",2020,"There were no significant differences between groups in adverse events (12% for both groups; P=1.0), readmission to the hospital within 1 week (6% for the placebo group vs 1% for the antibiotic group; P=.1), and readmission to the hospital within 30 days (6% for the placebo group vs 11% for the antibiotic group; P= .3).
","['patients with uncomplicated acute diverticulitis', '180 patients hospitalized for uncomplicated acute diverticulitis (determined by computed tomography, Hinchey 1a grade) from New Zealand and Australia', 'selected patients with uncomplicated acute diverticulitis']","['Antibiotic treatment', 'placebo vs antibiotic treatment', 'placebo', 'antibiotics']","['Length of Hospital Stay', 'length of hospital admission', 'median time of hospital stay', 'adverse events', 'readmission to the hospital', 'length of hospital stay; secondary endpoints included occurrence of adverse events, readmission to the hospital, procedural intervention, change in serum markers of inflammation, and patient-reported pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0518989', 'cui_str': 'Acute diverticulitis'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",180.0,0.661601,"There were no significant differences between groups in adverse events (12% for both groups; P=1.0), readmission to the hospital within 1 week (6% for the placebo group vs 1% for the antibiotic group; P=.1), and readmission to the hospital within 30 days (6% for the placebo group vs 11% for the antibiotic group; P= .3).
","[{'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Jaung', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Nisbet', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Martijn Pieter', 'Initials': 'MP', 'LastName': 'Gosselink', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Western Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Di Re', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Western Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Keane', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Milne', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': ""Su'a"", 'Affiliation': 'South Auckland Clinical School, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Siraj', 'Initials': 'S', 'LastName': 'Rajaratnam', 'Affiliation': 'Colorectal Unit, Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Grahame', 'Initials': 'G', 'LastName': 'Ctercteko', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Western Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hsee', 'Affiliation': 'Acute Surgical Unit, Department of Surgery, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rowbotham', 'Affiliation': 'Department of Gastroenterology and Hepatology, Auckland City Hospital, Auckland, New Zealand South Auckland Clinical School, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'South Auckland Clinical School, University of Auckland, Auckland, New Zealand; Department of Surgery, Counties Manukau Health, Auckland New Zealand.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Bissett', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand; Colorectal Unit, Department of Surgery, Auckland District Health Board, Auckland, New Zealand. Electronic address: i.bissett@auckland.ac.nz.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.03.049']
776,32236522,The Effects of Mat Pilates Training on Vascular Function and Body Fatness in Obese Young Women With Elevated Blood Pressure.,"BACKGROUND


Effective nonpharmacological interventions targeting the enhancement of vascular function and decline of body fatness (BF) in obese individuals are indispensable for the prevention of hypertension and cardiovascular events in young adults. Mat Pilates training (MPT) has gained significant popularity worldwide, yet its effects on vascular function and body composition are understudied. We examined the effects of MPT on vascular function and BF in young obese women with elevated blood pressure (BP).
METHODS


Twenty-eight young obese women with elevated BP were randomized to an MPT (n = 14) or a nonexercising control (CON, n = 14) group for 12 weeks. Systemic arterial stiffness (brachial-ankle pulse wave velocity (baPWV)), brachial and aortic BP, wave reflection (augmentation index (AIx)), plasma nitric oxide (NO) levels, and BF percentage (BF%) were assessed before and after 12 weeks.
RESULTS


MPT significantly reduced (P ˂ 0.05) baPWV (-0.7 ± 0.2 m/s), AIx (-4 ± 1%), brachial systolic BP (-5 ± 1 mm Hg), aortic systolic BP (-6 ± 1 mm Hg), and BF% (-2 ± 1%), while significantly increasing plasma NO (6 ± 2 µM) (P ˂ 0.05) compared with CON. MPT improved systemic arterial stiffness, aortic BP, wave reflection, circulating plasma NO, and BF% in young obese women with elevated BP.
CONCLUSIONS


MPT may be an effective intervention for the improvement of vascular function and BF in young obese women with elevated BP, a population at risk for hypertension and early vascular complications.
CLINICAL TRIALS REGISTRATION


Trial Number NCT03907384.",2020,"MPT improved systemic arterial stiffness, aortic BP, wave reflection, circulating plasma","['Twenty-eight young obese women with elevated BP', 'young obese women with elevated BP', 'obese individuals', 'young adults', 'young obese women with elevated blood pressure (BP', 'Obese Young Women With Elevated Blood Pressure']","['Mat Pilates Training', 'MPT', 'Mat Pilates training (MPT', 'nonexercising control (CON']","['Vascular Function and Body Fatness', 'Systemic arterial stiffness (brachial-ankle pulse wave velocity (baPWV)), brachial and aortic BP, wave reflection (augmentation index (AIx)), plasma nitric oxide (NO) levels, and BF percentage (BF', 'systemic arterial stiffness, aortic BP, wave reflection, circulating plasma', 'brachial systolic BP', 'vascular function and BF', 'aortic systolic BP']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",28.0,0.085763,"MPT improved systemic arterial stiffness, aortic BP, wave reflection, circulating plasma","[{'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, VA, USA.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Figueroa', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Fischer', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Health and Kinesiology, University of Nebraska-Omaha, Omaha, NE, USA.'}]",American journal of hypertension,['10.1093/ajh/hpaa026']
777,32243943,"Combined Treatment With Hydrocortisone, Vitamin C, and Thiamine for Sepsis and Septic Shock: A Randomized Controlled Trial.","BACKGROUND


Whether hydrocortisone, vitamin C, and thiamine treatment can reduce the mortality of patients with sepsis is controversial.
RESEARCH QUESTION


To evaluate the efficacy and safety of hydrocortisone, vitamin C, and thiamine combination treatment for patients with sepsis or septic shock.
STUDY DESIGN AND METHODS


This single-blind, randomized controlled trial evaluated treatment with hydrocortisone (50 mg every 6 h for 7 days), vitamin C (1.5 g every 6 h for 4 days), and thiamine (200 mg every 12 h for 4 days) vs placebo (normal saline) in patients with sepsis. The intention-to-treat analysis was used. Primary outcome was 28-day all-cause mortality, and secondary outcomes were organ protection, procalcitonin reduction, and adverse events related to hydrocortisone, vitamin C, and thiamine.
RESULTS


Eighty patients were randomized to receive combination treatment (n = 40) or normal saline (n = 40). No difference in 28-day all-cause mortality was observed (27.5% vs 35%, respectively; P = .47); however, treatment was associated with a significant improvement of 72-h change in Sequential Organ Failure Assessment score (P = .02). In adverse events analysis, the treatment group exhibited more incidents of hypernatremia (P = .005). In prespecified subgroup analysis, patients of the treatment subgroup diagnosed with sepsis within 48 h showed lower mortality than those in the control subgroup (P = .02). The study was terminated after the midterm analysis.
INTERPRETATION


Among patients with sepsis or septic shock, the combination of hydrocortisone, vitamin C, and thiamine did not reduce mortality compared with placebo.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT03258684; URL: www.clinicaltrials.gov.",2020,"In adverse events analysis, the treatment group exhibited more incidents of hypernatremia (P = 0.005).","['sepsis and septic shock (HYVCTTSSS', 'Eighty patients', 'patients with sepsis or septic shock', 'patients with sepsis']","['hydrocortisone, vitamin C, and thiamine treatment', 'placebo (normal saline', 'normal saline', 'vitamin C', 'hydrocortisone, vitamin C, and thiamine combination treatment', 'placebo', 'hydrocortisone, vitamin C, and thiamine', 'thiamine', 'hydrocortisone']","['lower mortality', '28-day all-cause mortality', '72-h ΔSOFA score', 'efficacy and safety', '28-day all-cause mortality, and secondary outcomes were organ protection, procalcitonin reduction, and adverse events related to hydrocortisone, vitamin C, and thiamine', 'incidents of hypernatremia']","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0020488', 'cui_str': 'Hypernatremia'}]",80.0,0.791428,"In adverse events analysis, the treatment group exhibited more incidents of hypernatremia (P = 0.005).","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chang', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': ""Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou; Department of Critical Care Medicine, Dongguan People's Hospital, Dongguan.""}, {'ForeName': 'Jianbin', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Yuexun', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Organ Transplant, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Organ Transplant, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Zhongran', 'Initials': 'Z', 'LastName': 'Cen', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Zhanguo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou. Electronic address: zhguoliu@163.com.'}]",Chest,['10.1016/j.chest.2020.02.065']
778,31806133,Impact of Renal Impairment on Beta-Blocker Efficacy in Patients With Heart Failure.,"BACKGROUND


Moderate and moderately severe renal impairment are common in patients with heart failure and reduced ejection fraction, but whether beta-blockers are effective is unclear, leading to underuse of life-saving therapy.
OBJECTIVES


This study sought to investigate patient prognosis and the efficacy of beta-blockers according to renal function using estimated glomerular filtration rate (eGFR).
METHODS


Analysis of 16,740 individual patients with left ventricular ejection fraction <50% from 10 double-blind, placebo-controlled trials was performed. The authors report all-cause mortality on an intention-to-treat basis, adjusted for baseline covariates and stratified by heart rhythm.
RESULTS


Median eGFR at baseline was 63 (interquartile range: 50 to 77) ml/min/1.73 m 2 ; 4,584 patients (27.4%) had eGFR 45 to 59 ml/min/1.73 m 2 , and 2,286 (13.7%) 30 to 44 ml/min/1.73 m 2 . Over a median follow-up of 1.3 years, eGFR was independently associated with mortality, with a 12% higher risk of death for every 10 ml/min/1.73 m 2  lower eGFR (95% confidence interval [CI]: 10% to 15%; p < 0.001). In 13,861 patients in sinus rhythm, beta-blockers reduced mortality versus placebo; adjusted hazard ratio (HR): 0.73 for eGFR 45 to 59 ml/min/1.73 m 2  (95% CI: 0.62 to 0.86; p < 0.001) and 0.71 for eGFR 30 to 44 ml/min/1.73 m 2  (95% CI: 0.58 to 0.87; p = 0.001). The authors observed no deterioration in renal function over time in patients with moderate or moderately severe renal impairment, no difference in adverse events comparing beta-blockers with placebo, and higher mortality in patients with worsening renal function on follow-up. Due to exclusion criteria, there were insufficient patients with severe renal dysfunction (eGFR <30 ml/min/1.73 m 2 ) to draw conclusions. In 2,879 patients with atrial fibrillation, there was no reduction in mortality with beta-blockers at any level of eGFR.
CONCLUSIONS


Patients with heart failure, left ventricular ejection fraction <50% and sinus rhythm should receive beta-blocker therapy even with moderate or moderately severe renal dysfunction.",2019,"In 2,879 patients with atrial fibrillation, there was no reduction in mortality with beta-blockers at any level of eGFR.
","['16,740 individual patients with left ventricular ejection fraction\xa0<50% from 10 double-blind', 'm 2 ; 4,584 patients (27.4%) had eGFR 45 to 59\xa0ml', 'Patients with heart failure, left ventricular ejection fraction\xa0<50% and sinus rhythm', 'patients with heart failure and reduced ejection fraction', '2,879 patients with atrial fibrillation', 'Patients', 'patients with severe renal dysfunction (eGFR\xa0<30']","['beta-blockers', 'placebo']","['adverse events', 'severe renal dysfunction', 'renal function', 'risk of death', 'Beta-Blocker Efficacy', 'glomerular filtration rate (eGFR', 'mortality with beta-blockers']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",2879.0,0.289216,"In 2,879 patients with atrial fibrillation, there was no reduction in mortality with beta-blockers at any level of eGFR.
","[{'ForeName': 'Dipak', 'Initials': 'D', 'LastName': 'Kotecha', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom; Centre of Cardiovascular Research and Education in Therapeutics, Monash University, Melbourne, Victoria, Australia. Electronic address: d.kotecha@bham.ac.uk.'}, {'ForeName': 'Simrat K', 'Initials': 'SK', 'LastName': 'Gill', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Marcus D', 'Initials': 'MD', 'LastName': 'Flather', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Science, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Holmes', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Rosano', 'Affiliation': ""Cardiovascular and Cell Science Institute, St. George's University of London, London, United Kingdom; Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Kardiologie, Angiologie und Internistische Intensivmedizin, Universitatsklinikum des Saarlandes, Homburg/Saar, Germany.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'Robertson Institute of Biostatistics and Clinical Trials Unit, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wikstrand', 'Affiliation': 'Wallenberg Laboratory for Cardiovascular Research, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology, Charite Campus Virchow-Klinikum, Berlin, Germany.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Centre Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Manzano', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Ramón y Cajal, Universidad de Alcalá (IRYCIS), Plaza de San Diego, Madrid, Spain.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'von Lueder', 'Affiliation': 'Centre of Cardiovascular Research and Education in Therapeutics, Monash University, Melbourne, Victoria, Australia; Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Rigby', 'Affiliation': 'Hull York Medical School, Faculty of Health Sciences, University of Hull, Kingston-upon-Hull, United Kingdom.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Andersson', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital and Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kjekshus', 'Affiliation': 'Rikshospitalet University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wedel', 'Affiliation': 'Health Metrics, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ruschitzka', 'Affiliation': 'Klinik fur Kardiologie, UniversitätsSpital Zürich, Zürich, Switzerland.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Damman', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Centre Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Redon', 'Affiliation': 'INCLIVA Biomedical Research Institute, Valencia, Spain.'}, {'ForeName': 'Andrew J S', 'Initials': 'AJS', 'LastName': 'Coats', 'Affiliation': 'Department of Medical Sciences, IRCCS San Raffaele Pisana, Roma, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.059']
779,32235518,"Effects of a Ketogenic Diet on Muscle Fatigue in Healthy, Young, Normal-Weight Women: A Randomized Controlled Feeding Trial.","Ketogenic low-carbohydrate high-fat (LCHF) diets are increasingly popular in broad sections of the population. The main objective of this study was to evaluate the effects of a non-energy-restricted ketogenic LCHF diet on muscle fatigue in healthy, young, and normal-weight women. Twenty-four women were randomly allocated to a 4-week ketogenic LCHF diet followed by a 4-week control diet (a National Food Agency recommended diet), or the reverse sequence due to the crossover design. Treatment periods were separated by a 15 week washout period. Seventeen women completed the study and were included in the analyses. Treatment effects were evaluated using mixed models. The ketogenic LCHF diet had no effect on grip strength or time to fatigue, measured with handgrip test (day 24-26). However, cycling time to fatigue decreased with almost two minutes (-1.85 min 95% CI:[-2.30;-1.40];  p  < 0.001) during incremental cycling (day 25-27), accommodated with higher ratings of perceived exertion using the Borg scale ( p  < 0.01). Participants' own diary notes revealed experiences of muscle fatigue during daily life activities, as well as during exercise. We conclude that in young and healthy women, a ketogenic LCHF diet has an unfavorable effect on muscle fatigue and might affect perceived exertion during daily life activities.",2020,"The ketogenic LCHF diet had no effect on grip strength or time to fatigue, measured with handgrip test (day 24-26).","['Twenty-four women', 'healthy, young, and normal-weight women', 'young and healthy women', 'Healthy, Young, Normal-Weight Women', 'Seventeen women completed the study and were included in the analyses']","['non-energy-restricted ketogenic LCHF diet', 'Ketogenic Diet', '4-week ketogenic LCHF diet followed by a 4-week control diet (a National Food Agency recommended diet', 'Ketogenic low-carbohydrate high-fat (LCHF) diets']","['Muscle Fatigue', 'muscle fatigue during daily life activities', 'grip strength or time to fatigue', 'cycling time to fatigue']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0559897', 'cui_str': 'Diet followed'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}]","[{'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",17.0,0.0451566,"The ketogenic LCHF diet had no effect on grip strength or time to fatigue, measured with handgrip test (day 24-26).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sjödin', 'Affiliation': 'Department of Food, Nutrition and Culinary Science, Umeå University, 90187 Umeå, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Hellström', 'Affiliation': 'Department of Occupational and Public Health Sciences, Centre for Musculoskeletal Research, University of Gävle, 80176 Gävle, Sweden.'}, {'ForeName': 'EwaCarin', 'Initials': 'E', 'LastName': 'Sehlstedt', 'Affiliation': 'Department of Food, Nutrition and Culinary Science, Umeå University, 90187 Umeå, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Svensson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Sports Medicine Unit, Umeå University, 90187 Umeå, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Burén', 'Affiliation': 'Department of Food, Nutrition and Culinary Science, Umeå University, 90187 Umeå, Sweden.'}]",Nutrients,['10.3390/nu12040955']
780,32235563,The Clinical Impact of Hexanic Extract of  Serenoa repens  in Men with Prostatic Inflammation: A Post Hoc Analysis of a Randomized Biopsy Study.,"A randomized biopsy study showed that hexanic  Serenoa repens  (HESr) treatment resulted in prostatic inflammation reduction. This post-hoc analysis evaluated the clinical impact of HESr and investigated correlations between baseline parameters and treatment response. Patients were randomized to receive HESr 320mg/day for six months or no therapy. Assessment included International Prostate Symptoms Score (IPSS), prostate volume (PV), and maximum flow rate (Qmax). Baseline characteristics were recorded, including body mass index (BMI) and metabolic syndrome (MetS) components. In patients under α1-adrenoceptor antagonists (α1-blockers), the addition of HESr resulted in statistically significant IPSS improvement after 6 months ( p  = 0.006). IPSS remained stable in patients under a1-blockers only ( p  = 0.346). Patients treated only with HESr reported a significant IPSS amelioration ( p  = 0.001). In the control group of naïve patients, no significant IPSS change was detected ( p  = 0.298). Baseline PV showed fair correlation ( r  = -0.20) with inflammation reduction in the HESr patients. BMI ( r  = 0.40), diabetes mellitus ( r  = 0.40), and PV ( r  = 0.23) showed fair correlation with Qmax increase but without reaching statistical significance. MetS ( p  = 0.06) was an influent biomarker for Qmax improvement. Treatment with HESr (as monotherapy or add-on therapy to a-blockers) may improve urinary symptoms in terms of IPSS in patients with prostatic inflammation.",2020,Patients treated only with HESr reported a significant IPSS amelioration ( p  = 0.001).,"['patients with prostatic inflammation', 'Men with Prostatic Inflammation']","['HESr', 'HESr 320mg/day for six months or no therapy', 'hexanic  Serenoa repens  (HESr', 'Hexanic Extract']","['IPSS amelioration', 'IPSS change', 'urinary symptoms', 'diabetes mellitus', 'IPSS', 'International Prostate Symptoms Score (IPSS), prostate volume (PV), and maximum flow rate (Qmax', 'prostatic inflammation reduction', 'IPSS improvement', 'body mass index (BMI) and metabolic syndrome (MetS) components', 'BMI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0697222', 'cui_str': 'Sabal serrulata'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0588805,Patients treated only with HESr reported a significant IPSS amelioration ( p  = 0.001).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Samarinas', 'Affiliation': 'Department of Urology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Mezourlo, 41110 Larissa, Greece.'}, {'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Karatzas', 'Affiliation': 'Department of Urology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Mezourlo, 41110 Larissa, Greece.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Tzortzis', 'Affiliation': 'Department of Urology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Mezourlo, 41110 Larissa, Greece.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Gravas', 'Affiliation': 'Department of Urology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Mezourlo, 41110 Larissa, Greece.'}]",Journal of clinical medicine,['10.3390/jcm9040957']
781,31566579,DNA priming and gp120 boosting induces HIV-specific antibodies in a randomized clinical trial.,"BACKGROUNDRV144 is the only preventive HIV vaccine regimen demonstrating efficacy in humans. Attempting to build upon RV144 immune responses, we conducted a phase 1, multicenter, randomized, double-blind trial to assess the safety and immunogenicity of regimens substituting the DNA-HIV-PT123 (DNA) vaccine for ALVAC-HIV in different sequences or combinations with AIDSVAX B/E (protein).METHODSOne hundred and four HIV-uninfected participants were randomized to 4 treatment groups (T1, T2, T3, and T4) and received intramuscular injections at 0, 1, 3, and 6 months (M): T1 received protein at M0 and M1 and DNA at M3 and M6; T2 received DNA at M0 and M1 and protein at M3 and M6; T3 received DNA at M0, M1, M3, and M6 with protein coadministered at M3 and M6; and T4 received protein and DNA coadministered at each vaccination visit.RESULTSAll regimens were well tolerated. Antibodies binding to gp120 and V1V2 scaffold were observed in 95%-100% of participants in T3 and T4, two weeks after final vaccination at high magnitude. While IgG3 responses were highest in T3, a lower IgA/IgG ratio was observed in T4. Binding antibodies persisted at 12 months in 35%-100% of participants. Antibody-dependent cell-mediated cytotoxicity and tier 1 neutralizing-antibody responses had higher response rates for T3 and T4, respectively. CD4+ T cell responses were detectable in all treatment groups (32%-64%) without appreciable CD8+ T cell responses.CONCLUSIONThe DNA/protein combination regimens induced high-magnitude and long-lasting HIV V1V2-binding antibody responses, and early coadministration of the 2 vaccines led to a more rapid induction of these potentially protective responses.TRIAL REGISTRATIONClinicalTrials.gov NCT02207920.FUNDINGNational Institute of Allergy and Infectious Diseases (NIAID) grants UM1 AI068614, UM1 AI068635, UM1 AI068618, UM1 AI069511, UM1 AI069470, UM1 AI069534, P30 AI450008, UM1 AI069439, UM1 AI069481, and UM1 AI069496; the National Center for Advancing Translational Sciences, NIH (grant UL1TR001873); and the Bill & Melinda Gates Foundation (grant OPP52845).",2019,"Antibody-dependent cell-mediated cytotoxicity and tier 1 neutralizing-antibody responses had higher response rates for T3 and T4, respectively.","['ALVAC-HIV in different sequences or combinations with AIDSVAX B/E (protein).METHODSOne hundred and four HIV-uninfected participants', 'humans']","['protein at M0 and M1 and DNA at M3 and M6; T2 received DNA at M0 and M1 and protein at M3 and M6; T3 received DNA at M0, M1, M3, and M6 with protein coadministered at M3 and M6; and T4 received protein and DNA coadministered at each vaccination visit', 'DNA-HIV-PT123 (DNA) vaccine']","['tolerated', 'Binding antibodies', 'HIV-specific antibodies', 'lower IgA/IgG ratio', 'CD4+ T cell responses', 'IgG3 responses']","[{'cui': 'C0675907', 'cui_str': 'ALVAC-HIV'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0020859', 'cui_str': 'IgG3'}]",,0.119543,"Antibody-dependent cell-mediated cytotoxicity and tier 1 neutralizing-antibody responses had higher response rates for T3 and T4, respectively.","[{'ForeName': 'Nadine G', 'Initials': 'NG', 'LastName': 'Rouphael', 'Affiliation': 'Hope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Morgan', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Shuying S', 'Initials': 'SS', 'LastName': 'Li', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Jensen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Sanchez', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Karuna', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Swann', 'Affiliation': 'Division of AIDS, NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Magdalena E', 'Initials': 'ME', 'LastName': 'Sobieszczyk', 'Affiliation': 'Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Frank', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Wilson', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Hong-Van', 'Initials': 'HV', 'LastName': 'Tieu', 'Affiliation': 'New York Blood Center, New York, New York, USA.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Maenza', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Norwood', 'Affiliation': 'UCSF, San Francisco, California, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kobie', 'Affiliation': 'Department of Medicine, University of Rochester School of Medicine & Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Faruk', 'Initials': 'F', 'LastName': 'Sinangil', 'Affiliation': 'Global Solutions for Infectious Diseases, South San Francisco, California, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Division of Immunology and Allergy, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'EuroVacc Foundation, Lausanne, Switzerland.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'De Rosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Keefer', 'Affiliation': 'Department of Medicine, University of Rochester School of Medicine & Dentistry, Rochester, New York, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of clinical investigation,['10.1172/JCI128699']
782,30640659,Self-reported cumulative medical opioid exposure and subjective responses on first use of opioids predict analgesic and subjective responses to placebo-controlled opioid administration.,"BACKGROUND AND OBJECTIVES


To expand the evidence base needed to enable personalized pain medicine, we evaluated whether self-reported cumulative exposure to medical opioids and subjective responses on first opioid use predicted responses to placebo-controlled opioid administration.
METHODS


In study 1, a survey assessing cumulative medical opioid exposure and subjective responses on first opioid use was created (History of Opioid Medical Exposure (HOME)) and psychometric features documented in a general sample of 307 working adults. In study 2, 49 patients with chronic low back pain completed the HOME and subsequently rated back pain intensity and subjective opioid effects four times after receiving saline placebo or intravenous morphine (four incremental doses) in two separate double-blinded laboratory sessions. Placebo-controlled morphine effects were derived for all outcomes.
RESULTS


Two HOME subscales were supported: cumulative opioid exposure and euphoric response, both demonstrating high test-retest reliability (Intraclass Correlation Coefficients > 0.93) and adequate internal consistency (Revelle's Omega Total = 0.73-0.77). In study 2, higher cumulative opioid exposure scores were associated with significantly greater morphine-related reductions in back pain intensity (p=0.02), but not with subjective drug effects. Higher euphoric response subscale scores were associated with significantly lower overall perceived morphine effect (p=0.003), less sedation (p=0.04), greater euphoria (p=0.03) and greater desire to take morphine again (p=0.02).
DISCUSSION


Self-reports of past exposure and responses to medical opioid analgesics may have utility for predicting subsequent analgesic responses and subjective effects. Further research is needed to establish the potential clinical and research utility of the HOME.
TRIAL REGISTRATION NUMBER


NCT02469077.",2019,"Higher euphoric response subscale scores were associated with significantly lower overall perceived morphine effect (p=0.003), less sedation (p=0.04), greater euphoria (p=0.03) and greater desire to take morphine again (p=0.02).
","['49 patients with chronic low back pain completed the HOME and subsequently rated back pain intensity and subjective opioid effects four times after receiving', '307 working adults']","['Placebo-controlled morphine', 'saline placebo or intravenous morphine', 'placebo']","['back pain intensity', 'greater euphoria', 'cumulative opioid exposure and euphoric response', 'adequate internal consistency', 'Higher euphoric response subscale scores', 'sedation', 'cumulative opioid exposure scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",307.0,0.219517,"Higher euphoric response subscale scores were associated with significantly lower overall perceived morphine effect (p=0.003), less sedation (p=0.04), greater euphoria (p=0.03) and greater desire to take morphine again (p=0.02).
","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bruehl', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA Stephen.Bruehl@vumc.org.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Stone', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Palmer', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Edwards', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Asokumar', 'Initials': 'A', 'LastName': 'Buvanendran', 'Affiliation': 'Department of Anesthesiology, Rush University, Chicago, Illinois, USA.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Chont', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Kennedy', 'Affiliation': 'Department of Behavioral Science, Rush University, Chicago, Illinois, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Department of Behavioral Science, Rush University, Chicago, Illinois, USA.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2018-000008']
783,32236732,Effects of ertugliflozin on renal function over 104 weeks of treatment: a post hoc analysis of two randomised controlled trials.,"AIMS/HYPOTHESIS


This study aimed to evaluate the effect of ertugliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, on eGFR and albuminuria (urine albumin/creatinine ratio [UACR]) vs glimepiride or placebo/glimepiride (non-ertugliflozin) over 104 weeks of treatment in participants with type 2 diabetes mellitus, using pooled data from two randomised controlled, active comparator studies from the eValuation of ERTugliflozin effIcacy and Safety (VERTIS) programme (Clinicaltrials.gov NCT01999218 [VERTIS SU] and NCT02033889 [VERTIS MET]). In the VERTIS SU study, ertugliflozin was evaluated vs glimepiride over 104 weeks. In the VERTIS MET study, ertugliflozin was evaluated vs placebo over 26 weeks; eligible participants were switched from placebo to blinded glimepiride from week 26 to week 104. The glycaemic efficacy of ertugliflozin vs non-ertugliflozin was also assessed in the pooled population.
METHODS


Post hoc, exploratory analysis was used to investigate mean changes from baseline in eGFR and UACR over 104 weeks.
RESULTS


Overall, mean (SD) baseline eGFR was 88.2 (18.8) ml min -1  (1.73 m) -2  and geometric mean (95% CI) of baseline UACR was 1.31 mg/mmol (1.23, 1.38). At week 6, the changes in eGFR from baseline were -2.3, -2.7 and -0.7 ml min -1  (1.73 m) -2  for the ertugliflozin 5 mg, ertugliflozin 15 mg and non-ertugliflozin groups, respectively. Mean eGFR in the ertugliflozin groups increased over time thereafter, while it decreased in the non-ertugliflozin group. Week 104 changes in eGFR from baseline were -0.2, 0.1 and -2.0 ml min -1  (1.73 m) -2  for the ertugliflozin 5 mg, ertugliflozin 15 mg and non-ertugliflozin groups, respectively. Among 415 patients (21.4% of the cohort) with albuminuria at baseline, the ertugliflozin groups had greater reductions in UACR at all measured time points up to week 104. At week 104, the non-ertugliflozin-corrected difference in UACR (95% CI) was -29.5% (-44.8, -9.8; p < 0.01) for ertugliflozin 5 mg and -37.6% (-51.8, -19.2; p < 0.001) for ertugliflozin 15 mg. Least squares mean changes from baseline in HbA 1c  (mmol/mol [95% CI]) at week 104 were similar between treatment groups: -6.84 (-7.64, -6.03), -7.74 (-8.54, -6.94) and -6.84 (-7.65, -6.03) in the ertugliflozin 5 mg, ertugliflozin 15 mg and non-ertugliflozin groups, respectively. Least squares mean changes from baseline in HbA1 c  (% [95% CI]) at week 104 were: -0.63 (-0.70, -0.55), -0.71 (-0.78, -0.64) and -0.63 (-0.70, -0.55) in the ertugliflozin 5 mg, ertugliflozin 15 mg and non-ertugliflozin groups, respectively.
CONCLUSIONS/INTERPRETATION


Ertugliflozin reduced eGFR at week 6, consistent with the known pharmacodynamic effects of SGLT2 inhibitors on renal function. Over 104 weeks, eGFR values returned to baseline and were higher with ertugliflozin compared with non-ertugliflozin treatment, even though changes in HbA 1c  did not differ between the groups. Ertugliflozin reduced UACR in patients with baseline albuminuria.
TRIAL REGISTRATION


clinicaltrials.gov NCT01999218 and NCT02033889.",2020,"At week 6, the changes in eGFR from baseline were -2.3, -2.7 and -0.7 ","['participants with type 2 diabetes mellitus', 'patients with baseline albuminuria']","['glimepiride', 'placebo', 'ertugliflozin 15\xa0mg and non-ertugliflozin', 'ertugliflozin vs non-ertugliflozin', 'Ertugliflozin', 'glimepiride or placebo/glimepiride (non-ertugliflozin', 'placebo to blinded glimepiride', 'ertugliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor', 'ertugliflozin']","['UACR', 'glycaemic efficacy', 'ERTugliflozin effIcacy and Safety (VERTIS) programme', 'eGFR and albuminuria (urine albumin/creatinine ratio [UACR', 'Overall, mean (SD) baseline eGFR', 'Mean eGFR', 'eGFR values', 'renal function']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]","[{'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4535690', 'cui_str': 'ertugliflozin 15 MG'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0455271', 'cui_str': 'Urine albumin/creatinine ratio measurement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",415.0,0.194555,"At week 6, the changes in eGFR from baseline were -2.3, -2.7 and -0.7 ","[{'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Division of Nephrology, University of Toronto, Toronto General Hospital, 585 University Ave, 8N-845, Toronto, ON, M5G 2N2, Canada. david.cherney@uhn.ca.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frederich', 'Affiliation': 'Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Maldonado', 'Affiliation': 'Merck Sharp & Dohme Limited, London, UK.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Zhi J', 'Initials': 'ZJ', 'LastName': 'Xu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Shrita', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA, USA.'}]",Diabetologia,['10.1007/s00125-020-05133-4']
784,32235569,The Role of Soluble Corn Fiber on Glycemic and Insulin Response.,"Increasing prevalence of type 2 diabetes mellitus (T2DM) in Asia has prompted the exploration of dietary fibers as an ingredient to attenuate glycemic response (GR). This study aims to compare the effects of replacing 50% of total carbohydrate with soluble corn fiber (SCF) or maltodextrin on the GR and insulin response (IR). In this randomized cross-over study, twenty-two healthy Chinese males aged between 21-60 years were recruited. The participants consumed glucose beverages and four test meals comprising SCF or maltodextrin in glutinous rice or as a drink. Repeated-measure ANOVA was used to compare the incremental area under the curve values of glucose (iAUGC) and insulin (iAUIC) of all the foods. Relative response (RR) of the beverages were also calculated and compared using paired t-test. SCF treatments had significantly lower iAUGC ( p -value < 0.05) and iAUIC ( p -value < 0.001) as compared to all treatments. Both treatments (rice and beverage) of maltodextrin were not significantly different from glucose ( p -value > 0.05). Maltodextrin beverage had significantly increased postprandial GR and insulin secretion by 20% and 40%, respectively, when compared to SCF beverage ( p -value < 0.001). This study shows that the inclusion of SCF into the diet is beneficial in controlling the postprandial GR. Replacing total carbohydrates with SCF effectively lowers GR and IR.",2020,SCF treatments had significantly lower iAUGC ( p -value < 0.05) and iAUIC ( p -value < 0.001) as compared to all treatments.,['twenty-two healthy Chinese males aged between 21-60 years were recruited'],"['total carbohydrate with soluble corn fiber (SCF) or maltodextrin', 'SCF', 'maltodextrin', 'SCF or maltodextrin', 'Maltodextrin', 'Soluble Corn Fiber']","['Glycemic and Insulin Response', 'iAUGC', 'GR and insulin response (IR', 'Relative response (RR) of the beverages', 'postprandial GR and insulin secretion', 'incremental area under the curve values of glucose (iAUGC) and insulin (iAUIC']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0143630', 'cui_str': 'Mast Cell Growth Factor'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",22.0,0.0207969,SCF treatments had significantly lower iAUGC ( p -value < 0.05) and iAUIC ( p -value < 0.001) as compared to all treatments.,"[{'ForeName': 'Wei Shuan Kimberly', 'Initials': 'WSK', 'LastName': 'Tan', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR) and National University Health System, Singapore 117599, Singapore.'}, {'ForeName': 'Pei Fen Winnie', 'Initials': 'PFW', 'LastName': 'Chia', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR) and National University Health System, Singapore 117599, Singapore.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Ponnalagu', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR) and National University Health System, Singapore 117599, Singapore.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Karnik', 'Affiliation': 'Innovation and Commercial Development, Tate & Lyle Ingredients Americans LLC, Hoffman Estates, IL 60192, USA.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR) and National University Health System, Singapore 117599, Singapore.'}]",Nutrients,['10.3390/nu12040961']
785,31908102,Effects of a mind map-based life review programme on psychospiritual well-being in cancer patients undergoing chemotherapy: A randomised controlled trial.,"OBJECTIVES


To evaluate the effects of a mind map-based life review programme (MBLRP) on psychological distress, hope, meaning in life and self-transcendence in cancer patients undergoing chemotherapy.
METHODS


Eighty-four cancer patients undergoing chemotherapy from a university-affiliated hospital in Fujian, China. The participants were randomly allocated to a MBLRP group (n = 40) or usual care group (n = 44). Data were collected at baseline (T0), on the second day (T1) and four weeks after the programme (T2) using the Distress Thermometer, Meaning in Life Questionnaire, Herth Hope Scale and Self-transcendence Scale.
RESULTS


No significant interaction effects for time and group membership were found for psychological distress either at T1 (t = -1.707, p = .090) or at T2 (t = -1.123, p = .263). The interaction effects for T1 and group membership were statistically significant for meaning in life (t = 3.487, p = .001) and hope (t = 5.313, p < .001), but not statistically significant for self-transcendence (t = 0.148, p = .882). The interaction effects for T2 and group membership were statistically significant for meaning in life (t = 2.592, p = .01), hope (t = 5.215, p < .001) and self-transcendence (t = 2.843, p = .005).
CONCLUSIONS


The MBLRP could improve hope, meaning in life and self-transcendence in cancer patients undergoing chemotherapy.",2020,"The interaction effects for T1 and group membership were statistically significant for meaning in life (t = 3.487, p = .001) and hope (t = 5.313, p < .001), but not statistically significant for self-transcendence (t = 0.148, p = .882).","['cancer patients undergoing', 'Eighty-four cancer patients undergoing chemotherapy from a university-affiliated hospital in Fujian, China', 'cancer patients undergoing chemotherapy']","['chemotherapy', 'MBLRP', 'mind map-based life review programme (MBLRP', 'MBLRP group (n\xa0=\xa040) or usual care group', 'mind map-based life review programme']","['self-transcendence', 'meaning in life', 'psychological distress', 'Distress Thermometer, Meaning in Life Questionnaire, Herth Hope Scale and Self-transcendence Scale', 'psychological distress, hope, meaning in life and self-transcendence']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0039818', 'cui_str': 'Thermometers'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0222045'}]",,0.0888213,"The interaction effects for T1 and group membership were statistically significant for meaning in life (t = 3.487, p = .001) and hope (t = 5.313, p < .001), but not statistically significant for self-transcendence (t = 0.148, p = .882).","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'School of Nursing, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Oncology, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Department of Oncology, Fujian Medical University Union Hospital, Fuzhou, China.'}]",European journal of cancer care,['10.1111/ecc.13221']
786,32234275,"Does Telehealth Delivery of a Dyadic Dementia Care Program Provide a Noninferior Alternative to Face-To-Face Delivery of the Same Program? A Randomized, Controlled Trial.","OBJECTIVE


This study aimed to determine whether delivery of a dyadic intervention using telehealth was noninferior to delivery of the same program using traditional face-to-face delivery through home visits.
DESIGN


We conducted a noninferiority randomized controlled trial.
PARTICIPANTS


Participants had a diagnosis of dementia, were living in the community, and had an informal caregiver who reported difficulties in managing activities of daily living or behavioral symptoms.
INTERVENTION


Participants were randomized to receive either telehealth or home visit delivery of the same intervention program.
MEASUREMENTS


The primary outcome was the Caregiving Mastery Index, secondary outcomes included caregiver's perceptions of change, activities of daily living function, and type and frequency of behavioral symptoms of persons living with dementia. Therapists delivering the intervention recorded the time spent delivering the intervention as well as travel time.
RESULTS


Sixty-three dyads were recruited and randomized. Both groups reported improvements for the primary outcome, however, these were not statistically significant. There were no significant differences between groups for the primary outcome (mean difference 0.09 (95% confidence interval -1.26 to 1.45) or the secondary outcomes at 4 months. Both groups reported significant improvements in caregiver's perceptions of change. The amount of time spent delivering the content of the program was similar between groups, however offering the intervention via telehealth significantly reduced travel time (mean 255.9 minutes versus mean 77.2 minutes, p <0.0001).
CONCLUSION


It is feasible to offer dyadic interventions via telehealth and doing so reduces travel time and results in similar benefits for families.",2020,"The amount of time spent delivering the content of the program was similar between groups, however offering the intervention via telehealth significantly reduced travel time (mean 255.9 minutes versus mean 77.2 minutes, p <0.0001).
","['Participants had a diagnosis of dementia, were living in the community, and had an informal caregiver who reported difficulties in managing activities of daily living or behavioral symptoms', 'Sixty-three dyads were recruited and randomized']",['telehealth or home visit delivery of the same intervention program'],"['travel time', ""Caregiving Mastery Index, secondary outcomes included caregiver's perceptions of change, activities of daily living function, and type and frequency of behavioral symptoms of persons living with dementia""]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1269688', 'cui_str': 'Activities of daily living management'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]",63.0,0.213133,"The amount of time spent delivering the content of the program was similar between groups, however offering the intervention via telehealth significantly reduced travel time (mean 255.9 minutes versus mean 77.2 minutes, p <0.0001).
","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Laver', 'Affiliation': 'College of Medicine and Public Health (KL, EL, OD, MC), Flinders University, Adelaide, South Australia, Australia. Electronic address: Kate.Laver@flinders.edu.au.'}, {'ForeName': 'Enwu', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': 'College of Medicine and Public Health (KL, EL, OD, MC), Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'University of Sydney (LC), Sydney, New South Wales, Australia.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Davies', 'Affiliation': 'College of Medicine and Public Health (KL, EL, OD, MC), Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'University of Queensland (LG), Queensland, Australia.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'Drexel University (LNG), Philadelphia, PA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'College of Medicine and Public Health (KL, EL, OD, MC), Flinders University, Adelaide, South Australia, Australia.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.02.009']
787,32234715,Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period.,"OBJECTIVE


Tanezumab, a nerve growth factor inhibitor, was investigated for osteoarthritis (OA) of the hip or knee in a study with 24-week treatment and 24-week safety follow-up.
METHODS


This double-blind, randomised, phase III study enrolled adults in Europe and Japan with moderate-to-severe OA who had not responded to or could not tolerate standard-of-care analgesics. Patients were randomised to tanezumab 2.5 mg or 5 mg subcutaneously or matching placebo every 8 weeks (three doses). Co-primary end points were change from baseline to week 24 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Physical Function, and Patient's Global Assessment of OA (PGA-OA). Joint safety and neurological assessments continued throughout the 48-week study.
RESULTS


From March 2016 to December 2017, 849 patients were randomised and evaluated (placebo n=282, tanezumab 2.5 mg n=283, tanezumab 5 mg n=284). At week 24, there was a statistically significant improvement from baseline for tanezumab 5 mg compared with placebo for WOMAC Pain (least squares mean difference±SE -0.62±0.18, p=0.0006), WOMAC Physical Function (-0.71±0.17, p<0.0001) and PGA-OA (-0.19±0.07, p=0.0051). For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA. Rapidly progressive osteoarthritis (RPOA) was observed in 1.4% (4/283) and 2.8% (8/284) of patients in the tanezumab 2.5 mg and tanezumab 5 mg groups, respectively and none receiving placebo. Total joint replacements (TJRs) were similarly distributed across all three treatment groups (6.7%-7.8%). Tanezumab-treated patients experienced more paraesthesia (5 mg) and hypoaesthesia (both doses) than placebo.
CONCLUSION


Tanezumab 5 mg statistically significantly improved pain, physical function and PGA-OA, but tanezumab 2.5 mg only achieved two co-primary end points. RPOA occurred more frequently with tanezumab 5 mg than tanezumab 2.5 mg. TJRs were similarly distributed across all three groups.
TRIAL REGISTRATION NUMBER


NCT02709486.",2020,"For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA.","['osteoarthritis of the hip or knee', 'From March 2016 to December 2017, 849 patients were randomised and evaluated ', 'phase III study enrolled adults in Europe and Japan with moderate-to-severe OA who had not responded to or could not tolerate standard-of-care analgesics']","['placebo n=282, tanezumab 2.5\u2009mg n=283, tanezumab', 'placebo', 'tanezumab', 'Tanezumab', 'tanezumab 2.5 mg or 5\u2009mg subcutaneously or matching placebo', 'Subcutaneous tanezumab']","['RPOA', 'paraesthesia', 'pain, physical function and PGA-OA', 'WOMAC Physical Function', 'Rapidly progressive osteoarthritis (RPOA', 'Total joint replacements (TJRs', 'WOMAC Pain', 'Western Ontario and McMaster Universities Osteoarthritis Index', 'Joint safety and neurological assessments', 'WOMAC Pain and Physical Function', ""WOMAC) Pain and Physical Function, and Patient's Global Assessment of OA (PGA-OA""]","[{'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2346819', 'cui_str': 'tanezumab'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C3854438', 'cui_str': 'Rapidly progressive osteoarthritis'}, {'cui': 'C4279925', 'cui_str': 'Total Joint Replacement'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",849.0,0.0446766,"For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA.","[{'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Berenbaum', 'Affiliation': 'Department of Rheumatology, Sorbonne Université, INSERM CRSA, AP-HP Hopital Saint Antoine, Paris, France francis.berenbaum@aphp.fr.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Blanco', 'Affiliation': 'Servicio de Reumatología, INIBC-Complejo Hospitalario Universitario A Coruña, La Coruña, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Department of Radiology, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Miki', 'Affiliation': 'Faculty of Health Science, Osaka Yukioka College of Health Science, Hayaishi Hospital, Osaka, Japan.'}, {'ForeName': 'Takaharu', 'Initials': 'T', 'LastName': 'Yamabe', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Viktrup', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Rod', 'Initials': 'R', 'LastName': 'Junor', 'Affiliation': 'Pfizer Ltd, Tadworth, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Carey', 'Affiliation': 'Pfizer Ltd, Tadworth, UK.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Brown', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Verburg', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216296']
788,32234462,"Evolocumab in HIV-Infected Patients With Dyslipidemia: Primary Results of the Randomized, Double-Blind BEIJERINCK Study.","BACKGROUND


People living with human immunodeficiency virus (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD) and are prone to statin-related adverse events from drug-drug interactions with certain antiretroviral regimens.
OBJECTIVES


This study sought to evaluate the efficacy and safety of evolocumab in dyslipidemic PLHIV.
METHODS


BEIJERINCK (EvolocumaB Effect on LDL-C Lowering in SubJEcts with Human Immunodeficiency VirRus and INcreased Cardiovascular RisK) is a randomized, double-blind, multinational trial comparing monthly subcutaneous evolocumab 420 mg with placebo in PLHIV with hypercholesterolemia/mixed dyslipidemia taking maximally-tolerated statin therapy. The primary endpoint was the percent change (baseline to week 24) in low-density lipoprotein cholesterol (LDL-C); secondary endpoints included achievement of LDL-C <70 mg/dl and percent change in other plasma lipid and lipoprotein levels. Treatment-emergent adverse events were also examined.
RESULTS


A total of 464 patients were analyzed (mean age of 56.4 years, 82.5% male, mean duration with HIV of 17.4 years). ASCVD was documented in 35.6% of patients, and statin intolerance/contraindications to statin use were present in 20.7% of patients. Evolocumab reduced LDL-C by 56.9% (95% confidence interval: 61.6% to 52.3%) from baseline to week 24 versus placebo. An LDL-C level of <70 mg/dl was achieved in 73.3% of patients in the evolocumab group versus 7.9% in the placebo group. Evolocumab also significantly reduced other atherogenic lipid levels, including non-high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) (all p < 0.0001). Evolocumab was well tolerated, and treatment-emergent adverse events patient incidence was similar among evolocumab and placebo groups.
CONCLUSIONS


Evolocumab was safe and significantly reduced lipid levels in dyslipidemic PLHIV on maximally-tolerated statin therapy. Evolocumab is an effective therapy for lowering atherogenic lipoproteins in PLHIV with high cardiovascular risk. (Safety, Tolerability & Efficacy on LDL-C of Evolocumab in Subjects With HIV & Hyperlipidemia/Mixed Dyslipidemia; NCT02833844).",2020,"Evolocumab reduced LDL-C by 56.9% (95% CI: 61.6%, 52.3%) from baseline to week 24 versus placebo.","['A total of 464 patients were analyzed (mean age of 56.4 years, 82.5% male, mean duration with HIV of 17.4 years', 'HIV-Infected Patients With Dyslipidemia', 'People living with HIV (PLHIV', 'PLHIV with hypercholesterolemia/mixed dyslipidemia taking maximally-tolerated statin therapy']","['Evolocumab', 'evolocumab', 'placebo', 'subcutaneous evolocumab 420 mg with placebo']","['efficacy and safety', 'LDL-C level', 'low-density lipoprotein cholesterol (LDL-C); secondary endpoints included achievement of LDL-C <70 mg/dL and percent change in other plasma lipid and lipoprotein levels', 'lipid levels', 'atherogenic lipid levels, including non-HDL-C, ApoB, and Lp(a', 'ASCVD', 'tolerated, and TEAE patient incidence', 'Evolocumab reduced LDL-C']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4517774', 'cui_str': '420'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0523753', 'cui_str': 'Lipoproteins measurement'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}]",464.0,0.420886,"Evolocumab reduced LDL-C by 56.9% (95% CI: 61.6%, 52.3%) from baseline to week 24 versus placebo.","[{'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Boccara', 'Affiliation': ""AP-HP, Hôpitaux de l'Est Parisien, Hôpital Saint-Antoine, Department of Cardiology, Sorbonne Université-INSERM UMR S_938, Centre de Recherche Saint-Antoine, Paris, France. Electronic address: franck.boccara@aphp.fr.""}, {'ForeName': 'Princy N', 'Initials': 'PN', 'LastName': 'Kumar', 'Affiliation': 'Division of Infectious Diseases and Travel Medicine, Georgetown University School of Medicine, Washington, DC.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Caramelli', 'Affiliation': 'Interdisciplinary Medicine in Cardiology Unit, InCor, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Calmy', 'Affiliation': 'HIV/AIDS Unit, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'J Antonio G', 'Initials': 'JAG', 'LastName': 'López', 'Affiliation': 'Global Development, Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bray', 'Affiliation': 'Global Development, Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Marcoli', 'Initials': 'M', 'LastName': 'Cyrille', 'Affiliation': 'Global Development, Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Rosenson', 'Affiliation': 'Cardiometabolics Unit, Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.03.025']
789,30664661,Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.,"BACKGROUND/OBJECTIVES


Prolonged-release (PR) naltrexone 32 mg/bupropion 360 mg (NB) is approved for chronic weight management as an adjunct to reduced-calorie diet and increased physical activity. Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo.
SUBJECTS/METHODS


Data were pooled from 5 prospective, double-blind, randomized, placebo-controlled clinical trials (duration range, 24-56 weeks) of NB in subjects with overweight or obesity. PAEs were collected via AE preferred terms, organized into major subtopics (e.g., anxiety, depression, sleep disorders), and divided into category terms (e.g., anxiety, potential anxiety symptoms). Additionally, the Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively.
RESULTS


Baseline characteristics and comorbidities were comparable for placebo (n = 1515) and NB (n = 2545). Most common PAEs in the NB group (using category grouping; NB vs placebo) were sleep disorders (12.7 vs 7.9%, P < 0.001), anxiety (5.4 vs 3.3%, P = 0.029), and depression (1.8 vs 2.7%, P = 0.014); PAEs were more frequent during dose escalation and generally mild or moderate. Mean (SD) changes in IDS-SR total score from baseline to endpoint were small in both groups: 0.13 (5.83) for NB and -0.45 (5.65) for placebo. Retrospective AE categorization via C-CASA confirmed no completed suicides, suicide attempts, or preparatory acts toward imminent suicidal behavior.
CONCLUSIONS


This large pooled analysis of 5 clinical trials provides additional safety information about the NB PAE profile. Anxiety and sleep disorder-related PAEs were more frequent with NB versus placebo but were mostly mild to moderate and generally occurred early. Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",2019,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",['subjects with overweight or obesity'],"['naltrexone/bupropion combination therapy', 'bupropion 360\u2009mg (NB', 'placebo']","['Depression-related PAEs', 'depression', 'suicidal ideation or behavior', 'Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively', 'Psychiatric adverse events', 'Mean (SD) changes in IDS-SR total score', 'Anxiety and sleep disorder-related PAEs', 'anxiety', 'sleep disorders']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0002045'}, {'cui': 'C3494753', 'cui_str': 'Suicide evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]",,0.497082,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Apovian', 'Affiliation': 'Boston University School of Medicine and Department of Medicine Section of Endocrinology, Diabetes and Nutrition, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Lindner Center of HOPE, Mason, and Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Annexon Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Lisette M', 'Initials': 'LM', 'LastName': 'Acevedo', 'Affiliation': 'Nalpropion Pharmaceuticals, Inc, La Jolla, CA, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA. frank.greenway@pbrc.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0302-z']
790,30938383,A Mediterranean diet does not alter plasma trimethylamine N-oxide concentrations in healthy adults at risk for colon cancer.,"An elevated circulating level of trimethylamine N-oxide (TMAO) has been identified as a risk factor for numerous diseases, including cardiovascular disease (CVD) and colon cancer. TMAO is formed from trimethylamine (TMA)-precursors such as choline via the combined action of the gut microbiota and liver. We conducted a Mediterranean diet intervention that increased intakes of fiber and changed intakes of many other foods containing fat to increase the relative amount of mono-unsaturated fats in the diet. The Mediterranean diet is associated with reduced risks of chronic diseases and might counteract the pro-inflammatory effects of increased TMAO formation. Therefore, the purpose of this study was to determine if the Mediterranean diet would reduce TMAO concentrations. Fasting TMAO concentrations were measured before and after six-months of dietary intervention in 115 healthy people at increased risk for colon cancer. No significant changes in plasma TMAO or in the ratios of TMAO to precursor compounds were found in either the Mediterranean group or the comparison group that followed a Healthy Eating diet. TMAO concentrations exhibited positive correlations with age and markers of metabolic health. TMAO concentrations were not associated with circulating cytokines, but the relative abundance of Akkermansia mucinophilia in colon biopsies was modestly and inversely correlated with baseline TMAO, choline, and betaine serum concentrations. These results suggest that broad dietary pattern intervention over six months may not be sufficient for reducing TMAO concentrations in an otherwise healthy population. Disruption of the conversion of dietary TMA to TMAO should be the focus of future studies.",2019,"TMAO concentrations were not associated with circulating cytokines, but the relative abundance of Akkermansia mucinophilia in colon biopsies was modestly and inversely correlated with baseline TMAO, choline, and betaine serum concentrations.","['115 healthy people at increased risk for colon cancer', 'healthy adults at risk for colon cancer']","['TMAO', 'trimethylamine N-oxide (TMAO', 'Mediterranean diet intervention']","['baseline TMAO, choline, and betaine serum concentrations', 'relative abundance of Akkermansia mucinophilia in colon biopsies', 'TMAO concentrations', 'Fasting TMAO concentrations', 'plasma TMAO', 'plasma trimethylamine']","[{'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}]","[{'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C1490589', 'cui_str': 'Genus Akkermansia (organism)'}, {'cui': 'C0192867', 'cui_str': 'Biopsy of colon (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0077172', 'cui_str': 'trimethylamine'}]",115.0,0.0170761,"TMAO concentrations were not associated with circulating cytokines, but the relative abundance of Akkermansia mucinophilia in colon biopsies was modestly and inversely correlated with baseline TMAO, choline, and betaine serum concentrations.","[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Griffin', 'Affiliation': 'Department of Food Science and Technology, Virginia Tech, Blacksburg, VA, USA. aneilso@ncsu.edu.'}, {'ForeName': 'Zora', 'Initials': 'Z', 'LastName': 'Djuric', 'Affiliation': 'Departments of Family Medicine and Nutritional Sciences, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Angiletta', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Cassie M', 'Initials': 'CM', 'LastName': 'Mitchell', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Baugh', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Davy', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Neilson', 'Affiliation': 'Department of Food Science and Technology, Virginia Tech, Blacksburg, VA, USA. aneilso@ncsu.edu.'}]",Food & function,['10.1039/c9fo00333a']
791,30938764,Metformin Improves Peripheral Insulin Sensitivity in Youth With Type 1 Diabetes.,"CONTEXT


Type 1 diabetes in adolescence is characterized by insulin deficiency and insulin resistance (IR), both thought to increase cardiovascular disease risk. We previously demonstrated that adolescents with type 1 diabetes have adipose, hepatic, and muscle IR, and that metformin lowers daily insulin dose, suggesting improved IR. However, whether metformin improves IR in muscle, hepatic, or adipose tissues in type 1 diabetes was unknown.
OBJECTIVE


Measure peripheral, hepatic, and adipose insulin sensitivity before and after metformin or placebo therapy in youth with obesity with type 1 diabetes.
DESIGN


Double-blind, placebo-controlled clinical trial.
SETTING


Multi-center at eight sites of the T1D Exchange Clinic Network.
PARTICIPANTS


A subset of 12- to 19-year-olds with type 1 diabetes (inclusion criteria: body mass index ≥85th percentile, HbA1c 7.5% to 9.9%, insulin dosing ≥0.8 U/kg/d) from a larger trial (NCT02045290) were enrolled.
INTERVENTION


Participants were randomized to 3 months of metformin (N = 19) or placebo (N = 18) and underwent a three-phase hyperinsulinemic euglycemic clamp with glucose and glycerol isotope tracers to assess tissue-specific IR before and after treatment.
MAIN OUTCOME MEASURES


Peripheral insulin sensitivity, endogenous glucose release, rate of lipolysis.
RESULTS


Between-group differences in change in insulin sensitivity favored metformin regarding whole-body IR [change in glucose infusion rate 1.3 (0.1, 2.4) mg/kg/min, P = 0.03] and peripheral IR [change in metabolic clearance rate 0.923 (-0.002, 1.867) dL/kg/min, P = 0.05]. Metformin did not impact insulin suppression of endogenous glucose release (P = 0.12). Adipose IR was not assessable with traditional methods in this highly IR population.
CONCLUSIONS


Metformin appears to improve whole-body and peripheral IR in youth who are overweight/obese with type 1 diabetes.",2019,Metformin did not impact insulin suppression of endogenous glucose release (P = 0.12).,"['Multi-center at eight sites of the T1D Exchange Clinic Network', 'youth who are overweight/obese with type 1 diabetes', 'youth with obesity with type 1 diabetes', 'Youth With Type 1 Diabetes', 'adolescents with type 1 diabetes', 'A subset of 12- to 19-year-olds with type 1 diabetes (inclusion criteria: body mass index ≥85th percentile, HbA1c 7.5% to 9.9%, insulin dosing ≥0.8 U/kg/d) from a larger trial (NCT02045290) were enrolled']","['metformin or placebo therapy', 'placebo', 'metformin', 'hyperinsulinemic euglycemic clamp with glucose and glycerol isotope tracers', 'Metformin']","['insulin sensitivity', 'Adipose IR', 'Peripheral Insulin Sensitivity', 'peripheral IR [change in metabolic clearance rate', 'Peripheral insulin sensitivity, endogenous glucose release, rate of lipolysis', 'body IR [change in glucose infusion rate', 'endogenous glucose release', 'IR in muscle, hepatic, or adipose tissues']","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1300561', 'cui_str': 'unit/kg'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0022262', 'cui_str': 'Isotopes'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0025515', 'cui_str': 'Metabolic Clearance Rate'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}]",,0.060328,Metformin did not impact insulin suppression of endogenous glucose release (P = 0.12).,"[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cree-Green', 'Affiliation': 'Division of Pediatric Endocrinology, Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Bryan C', 'Initials': 'BC', 'LastName': 'Bergman', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cengiz', 'Affiliation': 'Yale School of Medicine University, New Haven, Connecticut.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Fox', 'Affiliation': ""Nemours Children's Specialty Care, Jacksonville, Florida.""}, {'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetology, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Kellee', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Nathan', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pyle', 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Kahn', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tansey', 'Affiliation': 'Stead Family Department of Pediatrics, Endocrinology and Diabetes, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Tichy', 'Affiliation': 'Yale School of Medicine University, New Haven, Connecticut.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Tsalikian', 'Affiliation': 'Stead Family Department of Pediatrics, Endocrinology and Diabetes, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Libman', 'Affiliation': ""Children's Hospital of Pittsburgh at University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': 'Division of Pediatric Endocrinology, Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00129']
792,32230721,"The Oak-wood Extract Robuvit ®  Improves Recovery and Oxidative Stress after Hysterectomy: A Randomized, Double-blind, Placebo-controlled Pilot Study.","Hysterectomy has a variety of medical indications and improves pre-operative symptoms but might compromise the quality of life during recovery due to symptoms such as fatigue, headache, nausea, depression, or pain. The aim of the present study was to determine the effect of a standardized extract from French oak wood ( Quercus   robur ) containing at least 40% polyphenols of the ellagitannins class, Robuvit ® , on convalescence and oxidative stress of women after hysterectomy. Recovery status was monitored with the SF-36 questionnaire. The supplementation with Robuvit ®  (300 mg/day) during 4 weeks significantly improved general and mental health, while under placebo some items significantly deteriorated. Oxidative stress and enhancement of MMP-9 activity was significantly reduced by Robuvit ®  versus placebo. After 8 weeks of intervention, the patients' condition improved independently of the intervention. Our results suggest that the use of Robuvit ®  as a natural supplement relieves post-operative symptoms of patients after hysterectomy and reduces oxidative stress. The study was registered with ID ISRCTN 11457040 (13/09/2019).",2020,"The supplementation with Robuvit ®  (300 mg/day) during 4 weeks significantly improved general and mental health, while under placebo some items significantly deteriorated.","['women after hysterectomy', 'after Hysterectomy']","['Placebo', 'Hysterectomy', 'placebo', 'standardized extract from French oak wood ( Quercus   robur ) containing at least 40% polyphenols of the ellagitannins class, Robuvit ®']","['Oxidative stress and enhancement of MMP-9 activity', 'Recovery and Oxidative Stress', 'general and mental health', 'fatigue, headache, nausea, depression, or pain', 'oxidative stress']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0330302', 'cui_str': 'Quercus'}, {'cui': 'C0043217', 'cui_str': 'Wood'}, {'cui': 'C0330306', 'cui_str': 'Quercus robur (organism)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C3850290', 'cui_str': 'Robuvit'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.231729,"The supplementation with Robuvit ®  (300 mg/day) during 4 weeks significantly improved general and mental health, while under placebo some items significantly deteriorated.","[{'ForeName': 'Vladimír', 'Initials': 'V', 'LastName': 'Ferianec', 'Affiliation': 'Department of II. Gynecology and Obstetrics, Medical Faculty, Comenius University, 82606 Bratislava, Slovakia.'}, {'ForeName': 'Matej', 'Initials': 'M', 'LastName': 'Fülöp', 'Affiliation': 'Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Medical Faculty, Comenius University, 81108 Bratislava, Slovakia.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ježovičová', 'Affiliation': 'Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Medical Faculty, Comenius University, 81108 Bratislava, Slovakia.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Radošinská', 'Affiliation': 'Institute of Physiology, Faculty of Medicine, Comenius University in Bratislava, 81108 Bratislava, Slovakia.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Husseinová', 'Affiliation': 'Institute of Physiology, Faculty of Medicine, Comenius University in Bratislava, 81108 Bratislava, Slovakia.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Feriancová', 'Affiliation': 'Department of II. Gynecology and Obstetrics, Medical Faculty, Comenius University, 82606 Bratislava, Slovakia.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Radošinská', 'Affiliation': 'Faculty of Natural Sciences, Comenius University in Bratislava, 84215 Bratislava, Slovakia.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Barančík', 'Affiliation': 'Center of Experimental Medicine, Institute for Heart Research, Slovak Academy of Sciences, 84104 Bratislava, Slovakia.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Muchová', 'Affiliation': 'Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Medical Faculty, Comenius University, 81108 Bratislava, Slovakia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Hȍgger', 'Affiliation': 'Institut für Pharmazie und Lebensmittelchemie, Universität Würzburg, 97074 Würzburg, Germany.'}, {'ForeName': 'Zdeňka', 'Initials': 'Z', 'LastName': 'Ďuračková', 'Affiliation': 'Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Medical Faculty, Comenius University, 81108 Bratislava, Slovakia.'}]",Nutrients,['10.3390/nu12040913']
793,32229495,"Evaluation of the Effect of Contezolid (MRX-I) on the Corrected QT Interval in a Randomized, Double-Blind, Placebo- and Positive-Controlled Crossover Study in Healthy Chinese Volunteers.","Contezolid (MRX-I), a new oxazolidinone, is an antibiotic in development for treating complicated skin and soft tissue infections caused by resistant Gram-positive bacteria. This was a thorough QT study conducted in 52 healthy subjects who were administered oral contezolid at a therapeutic (800 mg) dose, a supratherapeutic (1,600 mg) dose, placebo, and oral moxifloxacin at 400 mg in four separate treatment periods. The pharmacokinetic profile of contezolid was also evaluated. Time point analysis indicated that the upper bounds of the two-sided 90% confidence interval (CI) for placebo-corrected change-from-baseline QTc (ΔΔQTc) were <10 ms for the contezolid therapeutic dose at each time point. The upper bound of the 90% CI for ΔΔQTc was slightly more than 10 ms with the contezolid supratherapeutic dose at 3 and 4 h postdose, and the prolongation effect on the QT/QTc interval was less than that of the positive control, moxifloxacin, at 400 mg. At 3 and 4 h after the moxifloxacin dose, the moxifloxacin group met the assay sensitivity criteria outlined in ICH Guidance E14 by having a lower confidence bound of ≥5 ms. The results of a linear exposure-response model which were similar to that of a time point analysis demonstrated a slightly positive relationship between contezolid plasma levels and ΔQTcF interval with a slope of 0.227 ms per mg/liter (90% CI, 0.188 to 0.266). In summary, contezolid did not prolong the QT interval at a therapeutic dose and may have a slight effect on QT interval prolongation at a supratherapeutic dose.",2020,Time-point analysis indicated that the upper bounds of the two-sided 90% confidence interval (CI) for placebo-corrected change-from-baseline QTc (ΔΔQTc) were <10 ms for the contezolid therapeutic dose at each time point.,"['52 healthy subjects who were administered', 'healthy Chinese volunteers']","['placebo', 'placebo, and oral moxifloxacin', 'moxifloxacin', 'oral contezolid', 'supratherapeutic', 'contezolid (MRX-I']","['QT interval prolongation', 'contezolid plasma levels and ΔQTcF interval', 'QT interval']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",52.0,0.16154,Time-point analysis indicated that the upper bounds of the two-sided 90% confidence interval (CI) for placebo-corrected change-from-baseline QTc (ΔΔQTc) were <10 ms for the contezolid therapeutic dose at each time point.,"[{'ForeName': 'Junzhen', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Cao', 'Affiliation': 'Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Hailan', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yuancheng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Beining', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Jicheng', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Kanhong', 'Initials': 'K', 'LastName': 'Ni', 'Affiliation': 'Department of Cardiology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jufang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China zhangj_fudan@aliyun.com xiyuewen@medmail.com.cn.'}, {'ForeName': 'Yuewen', 'Initials': 'Y', 'LastName': 'Xi', 'Affiliation': 'Department of Cardiology, Huashan Hospital, Fudan University, Shanghai, China zhangj_fudan@aliyun.com xiyuewen@medmail.com.cn.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02158-19']
794,32230754,Effects of Olive Oil Consumption on Cardiovascular Risk Factors in Patients with Fibromyalgia.,"We have recently reported that patients with fibromyalgia (FM) may be at increased risk for cardiovascular disease. Olive oil reportedly has cardioprotective effects. We examined the influence of olive oil consumption on cardiovascular risk factors in FM. This preliminary study was performed on blood samples of women with FM who consumed 50 mL of organic olive oil daily for 3 weeks. Patients were randomized into two groups: 15 women ingested extra virgin olive oil (EVOO) and 15 refined olive oil (ROO). Cardiovascular risk markers were measured at baseline (pre measure) and after consumption of olive oil (post measure). Red blood cell count and erythrocyte sedimentation rate (ESR; both  p  < 0.05) declined significantly post-treatment in the EVOO group. Consumption of ROO increased mean platelet volume and reduced platelet distribution width (PDW), neutrophil-to-lymphocyte ratio, ESR and fibrinogen (all  p  < 0.05). Significant differences were found in pre-post change between the EVOO and ROO groups for cortisol and PDW (both  p  < 0.05). Our results have shown that consumption of olive oil may have antithrombotic and antiinflammatory properties in patients with FM, thereby improving a number of cardiovascular risk markers. Both EVOO and ROO may be useful as adjuvants for the prevention and/or treatment of cardiovascular disorders in these patients.",2020,Red blood cell count and erythrocyte sedimentation rate (ESR; both  p  < 0.05) declined significantly post-treatment in the EVOO group.,"['patients with fibromyalgia (FM', 'Patients with Fibromyalgia', 'women with FM who consumed 50 mL of organic olive oil daily for 3 weeks', 'patients with FM']","['Olive Oil Consumption', 'Olive oil', 'olive oil consumption', '15 women ingested extra virgin olive oil (EVOO) and 15 refined olive oil (ROO']","['Consumption of ROO increased mean platelet volume and reduced platelet distribution width (PDW), neutrophil-to-lymphocyte ratio, ESR and fibrinogen', 'Cardiovascular Risk Factors', 'cardioprotective effects', 'cortisol and PDW', 'Red blood cell count and erythrocyte sedimentation rate (ESR', 'Cardiovascular risk markers', 'cardiovascular risk factors']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0200665', 'cui_str': 'Mean Platelet Volume'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0427565', 'cui_str': 'Platelet distribution width measurement'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1287262', 'cui_str': 'Finding of red blood cell count (finding)'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}]",,0.0772352,Red blood cell count and erythrocyte sedimentation rate (ESR; both  p  < 0.05) declined significantly post-treatment in the EVOO group.,"[{'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Rus', 'Affiliation': 'Department of Cell Biology, University of Granada, Avenida de la Fuentenueva, s/n, 18071 Granada, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Molina', 'Affiliation': 'Department of Health Science, University of Jaén, Campus Las Lagunillas s/n, 23071 Jaén, Spain.'}, {'ForeName': 'María Josefa', 'Initials': 'MJ', 'LastName': 'Martínez-Ramírez', 'Affiliation': 'Department of Health Science, University of Jaén, Campus Las Lagunillas s/n, 23071 Jaén, Spain.'}, {'ForeName': 'María Encarnación', 'Initials': 'ME', 'LastName': 'Aguilar-Ferrándiz', 'Affiliation': 'Instituto de Investigación Biosanitaria ibs.GRANADA, 18012 Granada, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Carmona', 'Affiliation': 'Department of Cell Biology, University of Granada, Avenida de la Fuentenueva, s/n, 18071 Granada, Spain.'}, {'ForeName': 'María Luisa', 'Initials': 'ML', 'LastName': 'Del Moral', 'Affiliation': 'Department of Experimental Biology, University of Jaén, Campus Las Lagunillas s/n, 23071 Jaén, Spain.'}]",Nutrients,['10.3390/nu12040918']
795,32230954,Effects of Leucine Administration in Sarcopenia: A Randomized and Placebo-controlled Clinical Trial.,"Treating sarcopenia in older individuals remains a challenge, and nutritional interventions present promising approaches in individuals that perform limited physical exercise. We assessed the efficacy of leucine administration to evaluate whether the regular intake of this essential amino acid can improve muscle mass, muscle strength and functional performance and respiratory muscle function in institutionalized older individuals. The study was a placebo-controlled, randomized, double-blind design in fifty participants aged 65 and over (ClinicalTrials.gov identifier NCT03831399). The participants were randomized to a parallel group intervention of 13 weeks' duration with a daily intake of leucine (6 g/day) or placebo (lactose, 6 g/day). The primary outcome was to study the effect on sarcopenia and respiratory muscle function. The secondary outcomes were changes in the geriatric evaluation scales, such as cognitive function, functional impairment and nutritional assessments. We also evaluated whether leucine administration alters blood analytical parameters and inflammatory markers. Administration of leucine was well-tolerated and significantly improves some criteria of sarcopenia in elderly individuals such as functional performance measured by walking time ( p  = 0.011), and improved lean mass index. For respiratory muscle function, the leucine-treated group improved significantly ( p  = 0.026) in maximum static expiratory force compared to the placebo. No significant effects on functional impairment, cognitive function or nutritional assessment, inflammatory cytokines IL-6, TNF-alpha were observed after leucine administration compared to the placebo. The use of l-leucine supplementation can have some beneficial effects on sarcopenia and could be considered for the treatment of sarcopenia in older individuals.",2020,"Administration of leucine was well-tolerated and significantly improves some criteria of sarcopenia in elderly individuals such as functional performance measured by walking time ( p  = 0.011), and improved lean mass index.","['institutionalized older individuals', 'fifty participants aged 65 and over (ClinicalTrials.gov identifier NCT03831399', 'older individuals', 'Sarcopenia']","['placebo', 'placebo (lactose', 'Leucine', 'leucine', 'Placebo', 'l-leucine supplementation']","['maximum static expiratory force', 'sarcopenia and respiratory muscle function', 'geriatric evaluation scales, such as cognitive function, functional impairment and nutritional assessments', 'muscle mass, muscle strength and functional performance and respiratory muscle function', 'functional impairment, cognitive function or nutritional assessment, inflammatory cytokines IL-6, TNF-alpha', 'lean mass index']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0222045'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0028708', 'cui_str': 'Nutritional Assessment'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C3853978'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",50.0,0.451043,"Administration of leucine was well-tolerated and significantly improves some criteria of sarcopenia in elderly individuals such as functional performance measured by walking time ( p  = 0.011), and improved lean mass index.","[{'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Martínez-Arnau', 'Affiliation': 'Department of Physiotherapy, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Fonfría-Vivas', 'Affiliation': 'Frailty and Cognitive Impairment Research Group (FROG), University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Buigues', 'Affiliation': 'Frailty and Cognitive Impairment Research Group (FROG), University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Castillo', 'Affiliation': 'La Saleta, Armonea Group, 46015 Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Molina', 'Affiliation': 'La Saleta, Armonea Group, 46015 Valencia, Spain.'}, {'ForeName': 'Aldert J', 'Initials': 'AJ', 'LastName': 'Hoogland', 'Affiliation': 'Natura Foundation, Numansdorp 3281 NC, The Netherlands.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'van Doesburg', 'Affiliation': 'Natura Foundation, Numansdorp 3281 NC, The Netherlands.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Pruimboom', 'Affiliation': 'University of Groningen, University Medical Center Groningen (UMCG), Groningen 9712 CP, The Netherlands.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Fernández-Garrido', 'Affiliation': 'Frailty and Cognitive Impairment Research Group (FROG), University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Cauli', 'Affiliation': 'Frailty and Cognitive Impairment Research Group (FROG), University of Valencia, 46010 Valencia, Spain.'}]",Nutrients,['10.3390/nu12040932']
796,32230987,Randomised Double-Blind Placebo-Controlled Trial of Inulin with Metronidazole in Non-Alcoholic Fatty Liver Disease (NAFLD).,"Background : Non-alcoholic fatty liver disease (NAFLD) can be ameliorated by weight loss although difficult to maintain. Emerging evidence indicates that prebiotics and antibiotics improve NAFLD.  Aim : To determine whether inulin supplementation after brief metronidazole therapy is effective in reducing alanine aminotransferase (ALT) and maintaining weight loss achieved through a very-low-calorie diet (VLCD) among people with NAFLD.  Methods : Sixty-two people with NAFLD commenced 4-week VLCD using Optifast meal replacements (600 kcal/day). Sixty were then randomised into a 12-week double-blind, placebo-controlled, parallel three-arm trial: (1) 400 mg metronidazole twice daily in Week 1 then inulin 4 g twice daily OR (2) placebo twice daily in week one then inulin OR (3) placebo-placebo. Main outcomes were ALT and body weight at 12 weeks. Fecal microbiota changes were also evaluated.  Results : Mean body mass index (BMI) and ALT reduced after VLCD by 2.4 kg/m 2  and 11 U/L, respectively. ALT further decreased after metronidazole-inulin compared to after placebo-placebo (mean ALT change -19.6 vs. -0.2 U/L, respectively;  p  = 0.026); however, weight loss maintenance did not differ. VLCD treatment decreased the ratio of  Firmicutes / Bacteroidetes  ( p  = 0.002).  Conclusion : Brief metronidazole followed by inulin supplementation can reduce ALT beyond that achieved after VLCD in patients with NAFLD.",2020,VLCD treatment decreased the ratio of  Firmicutes / Bacteroidetes  ( p  = 0.002).  ,"['patients with NAFLD', 'Alcoholic Fatty Liver Disease (NAFLD', 'Non', 'people with NAFLD', 'Sixty-two people with NAFLD commenced 4-week']","['placebo-placebo', 'placebo', 'metronidazole', 'Placebo', 'Inulin with Metronidazole', 'VLCD', 'inulin supplementation', 'metronidazole-inulin', 'metronidazole therapy']","['ALT and body weight', 'Fecal microbiota changes', 'alanine aminotransferase (ALT) and maintaining weight loss', 'ALT', 'weight loss maintenance', 'ratio of  Firmicutes / Bacteroidetes', 'Mean body mass index (BMI) and ALT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0015696', 'cui_str': 'Fatty Liver, Alcoholic'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1254144', 'cui_str': 'Firmicutes'}, {'cui': 'C0995456', 'cui_str': 'Bacteroidetes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.506217,VLCD treatment decreased the ratio of  Firmicutes / Bacteroidetes  ( p  = 0.002).  ,"[{'ForeName': 'Clara Yieh Lin', 'Initials': 'CYL', 'LastName': 'Chong', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland 1142, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Orr', 'Affiliation': 'New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland 1023, New Zealand.'}, {'ForeName': 'Lindsay D', 'Initials': 'LD', 'LastName': 'Plank', 'Affiliation': 'Department of Surgery, Faculty of Medical and Health Sciences, The University of Auckland, Auckland 1142, New Zealand.'}, {'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Vatanen', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland 1142, New Zealand.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': ""O'Sullivan"", 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland 1142, New Zealand.'}, {'ForeName': 'Rinki', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland 1142, New Zealand.'}]",Nutrients,['10.3390/nu12040937']
797,32231103,Replacing Animal-Based Proteins with Plant-Based Proteins Changes the Composition of a Whole Nordic Diet-A Randomised Clinical Trial in Healthy Finnish Adults.,"Increased consumption of plant-based foods and decreased consumption of animal-based foods is recommended for healthy diets and sustainable food production. We investigated the effects of partial replacement of dietary animal proteins with plant-based ones on intake of energy-yielding nutrients, fibre, and plasma lipoproteins. This 12-week randomised clinical intervention comprised 107 women and 29 men (20-69 years) in three diet groups with different dietary protein compositions (""ANIMAL"": Animal 70%/plant 30%; ""50/50"": Animal 50%/plant 50%; ""PLANT"": Animal 30%/plant 70%; all: Protein intake 17 E%). Nutrient intakes were assessed by 4-day food records. Saturated fat intake (E%) was lower and polyunsaturated fatty acid intake (E%) higher in the PLANT and 50/50 groups compared to the ANIMAL group ( p  < 0.001 for all). Fibre intake was higher in the PLANT ( p  ˂ 0.001) and 50/50 ( p  = 0.012) groups. Total and LDL cholesterol were lower in the PLANT than in the ANIMAL group ( p  = 0.003 for both) but no differences in HDL cholesterol or triglycerides were observed ( p  > 0.05). Replacing animal protein with plant protein sources in the diet led to an increased fibre intake and improved dietary fat quality as well as blood lipoprotein profile. Flexitarian diets could provide healthy and more sustainable alternatives for the current, predominantly animal-based diets.",2020,Fibre intake was higher in the PLANT ( p  ˂ 0.001) and 50/50 ( p  = 0.012) groups.,"['Healthy Finnish Adults', '107 women and 29 men (20-69 years) in three diet groups with different']","['Flexitarian diets', 'partial replacement of dietary animal proteins with plant', 'dietary protein compositions (""ANIMAL"": Animal 70%/plant 30%; ""50/50"": Animal']","['HDL cholesterol or triglycerides', 'Nutrient intakes', 'Fibre intake', 'Total and LDL cholesterol', 'fibre intake and improved dietary fat quality', 'blood lipoprotein profile']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0440447', 'cui_str': 'Animal protein'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C0012177', 'cui_str': 'Dietary Proteins'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0003062', 'cui_str': 'Animals'}]","[{'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0012171', 'cui_str': 'Dietary Fats'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}]",107.0,0.0244458,Fibre intake was higher in the PLANT ( p  ˂ 0.001) and 50/50 ( p  = 0.012) groups.,"[{'ForeName': 'Essi', 'Initials': 'E', 'LastName': 'Päivärinta', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66 (Agnes Sjöbergin katu 2), University of Helsinki, 00014 Helsinki, Finland.'}, {'ForeName': 'Suvi T', 'Initials': 'ST', 'LastName': 'Itkonen', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66 (Agnes Sjöbergin katu 2), University of Helsinki, 00014 Helsinki, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Pellinen', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66 (Agnes Sjöbergin katu 2), University of Helsinki, 00014 Helsinki, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Lehtovirta', 'Affiliation': 'Institute for Molecular Medicine Finland, University of Helsinki, P.O. Box 20, 00014 Helsinki, Finland.'}, {'ForeName': 'Maijaliisa', 'Initials': 'M', 'LastName': 'Erkkola', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66 (Agnes Sjöbergin katu 2), University of Helsinki, 00014 Helsinki, Finland.'}, {'ForeName': 'Anne-Maria', 'Initials': 'AM', 'LastName': 'Pajari', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, P.O. Box 66 (Agnes Sjöbergin katu 2), University of Helsinki, 00014 Helsinki, Finland.'}]",Nutrients,['10.3390/nu12040943']
798,31977576,The effects of antihypertensive class on gout in older adults: secondary analysis of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.,"OBJECTIVES


Gout is a common complication of blood pressure management and a frequently cited cause of medication nonadherence. Little trial evidence exists to inform antihypertensive selection with regard to gout risk.
METHODS


The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) was a randomized clinical trial on the effects of first-step hypertension therapy with amlodipine, chlorthalidone, or lisinopril on fatal coronary heart disease or nonfatal myocardial infarction (1994-2002). Trial participants were linked to CMS and VA gout claims (ICD9 274.XX). We determined the effect of drug assignment on gout with Cox regression models. We also determined the adjusted association of self-reported atenolol use (ascertained at the 1-month visit for indications other than hypertension) with gout.
RESULTS


Claims were linked to 23 964 participants (mean age 69.8 ± 6.8 years, 45% women, 31% black). Atenolol use was reported by 928 participants at the 1-month visit. Over a mean follow-up of 4.9 years, we documented 597 gout claims. Amlodipine reduced the risk of gout by 37% (hazard ratio 0.63; 95% CI 0.51--0.78) compared with chlorthalidone and by 26% (hazard ratio 0.74; 95% CI 0.58--0.94) compared with lisinopril. Lisinopril nonsignificantly lowered gout risk compared with chlorthalidone (hazard ratio 0.85; 95% CI 0.70--1.03). Atenolol use was not associated with gout risk (adjusted hazard ratio 1.18; 95% CI 0.78--1.80). Gout risk reduction was primarily observed after 1 year of follow-up.
CONCLUSION


Amlodipine lowered long-term gout risk compared with lisinopril or chlorthalidone. This finding may be useful in cases where gout risk is a principal concern among patients being treated for hypertension.This trial is registered at clinicaltrials.gov, number: NCT00000542.",2020,Amlodipine reduced the risk of gout by 37% (hazard ratio 0.63; 95% CI 0.51--0.78) compared with chlorthalidone and by 26% (hazard ratio 0.74; 95% CI 0.58--0.94) compared with lisinopril.,"['Claims were linked to 23\u200a964 participants (mean age 69.8\u200a±\u200a6.8 years, 45% women, 31% black', 'older adults', '928 participants at the 1-month visit', 'patients being treated for hypertension']","['Lisinopril', 'amlodipine, chlorthalidone, or lisinopril', 'lisinopril', 'chlorthalidone', 'Amlodipine', 'lisinopril or chlorthalidone', 'Atenolol', 'antihypertensive class']","['risk of gout', 'fatal coronary heart disease or nonfatal myocardial infarction', 'Gout risk reduction', 'gout risk']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",23964.0,0.236379,Amlodipine reduced the risk of gout by 37% (hazard ratio 0.63; 95% CI 0.51--0.78) compared with chlorthalidone and by 26% (hazard ratio 0.74; 95% CI 0.58--0.94) compared with lisinopril.,"[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Beth Israel Deaconess Medical Center, Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lara M', 'Initials': 'LM', 'LastName': 'Simpson', 'Affiliation': 'Department of Biostatistics, Health Science Center at Houston, University of Texas, Houston, Texas.'}, {'ForeName': 'Barry R', 'Initials': 'BR', 'LastName': 'Davis', 'Affiliation': 'Department of Biostatistics, Health Science Center at Houston, University of Texas, Houston, Texas.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Shmerling', 'Affiliation': 'Beth Israel Deaconess Medical Center, Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Beach', 'Affiliation': 'Beth Israel Deaconess Medical Center, Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ishak', 'Affiliation': 'Healthcare Associates, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Beth Israel Deaconess Medical Center, Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}]",Journal of hypertension,['10.1097/HJH.0000000000002359']
799,31451438,"Individual coronary plaque changes on serial CT angiography: Within-patient heterogeneity, natural history, and statin effects in HIV.","BACKGROUND


It is not known how the volume and composition of individual coronary plaques change over time in HIV-infected people and whether statins influence these changes.
METHODS


We included forty adults with HIV and subclinical coronary atherosclerosis who participated in a randomized controlled trial of placebo vs. atorvastatin. All participants underwent serial coronary computed tomography angiography at baseline and after one year. Individual coronary plaques were measured to assess the within-patient variability of plaque volume and composition changes. Left-main, proximal-right, proximal-left-anterior descending, and proximal-circumflex coronary segments were considered proximal. Plaque voxels with attenuation ≤130 Hounsfield Units (HU) were defined as noncalcified and further divided into fatty (<40HU) and fibrotic (40-130HU) components.
RESULTS


In 37 patients who completed the trial, there were 92 coronary plaques. Individual plaque changes varied highly, with some plaques increasing while others decreased in the same patient. Overall, 77% vs. 51% of individual plaques progressed, while 24% vs. 49% regressed in placebo and statin, respectively (p = 0.016). Substantial increases in proximal plaques drove the progression in placebo. Statins suppressed these large increases, resulting in a 3-fold lower variance in plaque volume change compared to placebo (p = 0.025). Statins suppressed progression of fibrotic (p = 0.015) plaque, with a trend towards reducing fatty (p = 0.075) plaque and no significant effect on the calcified portion (p = 0.203).
CONCLUSION


In persons with HIV, a population with increased atherosclerosis burden and cardiovascular risk, individual coronary plaque changes vary within a given individual. Large increases in proximal plaques characterize progression, and statins act in part by stabilizing progressing plaques by reducing fatty and fibrotic plaque components, without influencing the calcified portion.",2020,"Statins suppressed progression of fibrotic (p = 0.015) plaque, with a trend towards reducing fatty (p = 0.075) plaque and no significant effect on the calcified portion (p = 0.203).
","['forty adults with HIV and subclinical coronary atherosclerosis who participated in a randomized controlled trial of', '37 patients who completed the trial, there were 92 coronary plaques']","['serial coronary computed tomography angiography', 'placebo vs. atorvastatin', 'placebo']","['serial CT angiography', 'progression of fibrotic', 'proximal plaques', 'atherosclerosis burden and cardiovascular risk, individual coronary plaque changes', 'plaque volume change', 'Individual coronary plaques']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0010054', 'cui_str': 'Coronary Atherosclerosis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",92.0,0.152296,"Statins suppressed progression of fibrotic (p = 0.015) plaque, with a trend towards reducing fatty (p = 0.075) plaque and no significant effect on the calcified portion (p = 0.203).
","[{'ForeName': 'Borek', 'Initials': 'B', 'LastName': 'Foldyna', 'Affiliation': 'Cardiovascular Imaging Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Clinic for Radiology, Cardiovascular Center, Bad Neustadt an der Saale, Germany. Electronic address: bfoldyna@mgh.harvard.edu.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Program in Nutritional Metabolism, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mayrhofer', 'Affiliation': 'Cardiovascular Imaging Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; School of Business Studies, Stralsund University of Applied Sciences, Stralsund, Germany.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Program in Nutritional Metabolism, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiovascular Imaging Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lu', 'Affiliation': 'Cardiovascular Imaging Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}]",Journal of cardiovascular computed tomography,['10.1016/j.jcct.2019.08.011']
800,32229185,Comparing a patient positioning system to an overhead LIFT with pillows for impact on turning effectiveness.,"BACKGROUND


Frequent patient handling activities present numerous challenges to healthcare workers. A variety of products are available to assist with in-bed positioning but few comparative studies have been completed to ascertain turning effectiveness.
METHODS


The purpose of this study was to compare two turning devices (air-powered positioning system with wedges versus ceiling lift with pillows) for in-bed repositioning and turning effectiveness. The study took place at a large community hospital in the Midwestern USA and used a prospective, four-group crossover study design to compare devices.
RESULTS


The two turning groups were not significantly different for any of the demographic variables. The use of an air-powered positioning system with wedges achieved a greater degree of turn and maintained that turn after an hour better than the lift device with pillows. There were no hospital acquired pressure injuries in either group.
CONCLUSION


The devices used demonstrated significant differences in turn angle achieved and ability to maintain the turn at one hour. Future studies need to further delineate the ideal method for turning and compare devices to identify best practice and equipment. An effective turning method would integrate ease of use with the ability to achieve an optimal degree of turn in order to prevent hospital acquired pressure injuries while also decreasing caregiver injuries.",2020,"There were no hospital acquired pressure injuries in either group.
",[],['turning devices (air-powered positioning system with wedges versus ceiling lift with pillows'],['hospital acquired pressure injuries'],[],"[{'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439639', 'cui_str': 'Wedge (physical object)'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0182291', 'cui_str': 'Pillow, device (physical object)'}]","[{'cui': 'C0456393', 'cui_str': 'Hospital acquired (qualifier value)'}, {'cui': 'C0332679', 'cui_str': 'Pressure injury'}]",,0.0328385,"There were no hospital acquired pressure injuries in either group.
","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Powers', 'Affiliation': 'Parkview Health System, 11109 Parkview Plaza Drive, Fort Wayne, IN 46845 USA. Electronic address: jan.powers@parkview.com.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Beaubien', 'Affiliation': 'Parkview Health System, 11109 Parkview Plaza Drive, Fort Wayne, IN 46845 USA. Electronic address: Rebecca.beaubien@parkview.com.'}, {'ForeName': 'Tressa', 'Initials': 'T', 'LastName': 'Brunner', 'Affiliation': 'Parkview Research Center, 3948 A New Vision Drive, Fort Wayne, IN 46845 USA. Electronic address: Tressa.brunner@parkview.com.'}, {'ForeName': 'Kellie', 'Initials': 'K', 'LastName': 'Girardot', 'Affiliation': 'Parkview Health System, 11109 Parkview Plaza Drive, Fort Wayne, IN 46845 USA. Electronic address: Kellie.girardot@parkview.com.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rechter', 'Affiliation': 'Parkview Health System, 11109 Parkview Plaza Drive, Fort Wayne, IN 46845 USA. Electronic address: Jennifer.rechter@parkview.com.'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Richardson', 'Affiliation': 'Parkview Health System, 11109 Parkview Plaza Drive, Fort Wayne, IN 46845 USA. Electronic address: Janette.richardson@parkview.com.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2020.102847']
801,31292709,A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA study.,"BCD-055 is a biosimilar of innovator infliximab (IFX). Here we present the 54-week results from phase 3 clinical study in patients with rheumatoid arthritis (RA). The aim of this study was to demonstrate the equivalent efficacy and safety of BCD-055 and IFX in patients with active rheumatoid arthritis. 426 adults with active RA were enrolled. Patients were randomized into 2 study arms in 2:1 ratio to receive BCD-055 or IFX innovator in dose of 3 mg/kg at week 0, 2, 6 and then every 8 weeks up to week 54. Primary efficacy endpoint was the rate of American College of Rheumatology (ACR) 20 response at week 14. The equivalence margin was set as 15%. Immunogenicity and safety were also assessed. Rate of ACR20 at week 14 in PP (Per-Protocol) population was 71.2% in BCD-055 group and 67.9% in IFX group. Difference in ACR20 rates between groups was 3.2% with 95% CI [- 7.0%; 13.5%] (р = 0.587). Throughout 54-week study period, both groups were characterized by similar rates of ACR20/50/70 response at all timepoints without significant differences (p > 0.05). The rates of adverse events (AE) were similar in groups (74.64% in BCD-055 arm vs 66.67% in IFX arm, p = 0.111). Antibodies to infliximab were detected in 28.46% patients for BCD-055 arm and 26.56% for IFX arm (p = 0.786). BCD-055 and IFX were comparable in efficacy (including radiographic progression), safety and immunogenicity throughout the 54-week study.Trial registration ClinicalTrials.gov ID, number NCT02762838.",2019,"The rates of adverse events (AE) were similar in groups (74.64% in BCD-055 arm vs 66.67% in IFX arm, p = 0.111).","['426 adults with active RA were enrolled', 'patients with active rheumatoid arthritis', 'patients with rheumatoid arthritis (RA']","['BCD-055 or IFX innovator', 'innovator infliximab', 'BCD-055', 'BCD-055 and IFX']","['rates of adverse events (AE', 'efficacy (including radiographic progression), safety and immunogenicity', 'Antibodies to infliximab', 'Immunogenicity and safety', 'rate of American College of Rheumatology (ACR) 20 response', 'rates of ACR20/50/70 response', 'Rate of ACR20', 'ACR20 rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}]",426.0,0.0836367,"The rates of adverse events (AE) were similar in groups (74.64% in BCD-055 arm vs 66.67% in IFX arm, p = 0.111).","[{'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Lila', 'Affiliation': 'North-Western State Medical University named after I.I. Mechnikov, Saint Petersburg, Russia.'}, {'ForeName': 'Vadim I', 'Initials': 'VI', 'LastName': 'Mazurov', 'Affiliation': 'North-Western State Medical University named after I.I. Mechnikov, Saint Petersburg, Russia.'}, {'ForeName': 'Lev N', 'Initials': 'LN', 'LastName': 'Denisov', 'Affiliation': 'V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia.'}, {'ForeName': 'Olga B', 'Initials': 'OB', 'LastName': 'Nesmeyanova', 'Affiliation': 'State Budgetary Institution of Healthcare ""Chelyabinsk Regional Clinical Hospital"", Chelyabinsk, Russia.'}, {'ForeName': 'Elena P', 'Initials': 'EP', 'LastName': 'Ilivanova', 'Affiliation': 'State Budgetary Institution of Healthcare ""Leningrad Region Clinical Hospital"", Saint Petersburg, Russia.'}, {'ForeName': 'Anna V', 'Initials': 'AV', 'LastName': 'Eremeeva', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russia.'}, {'ForeName': 'Julia Valentinovna', 'Initials': 'JV', 'LastName': 'Usacheva', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russia. usacheva@biocad.ru.'}, {'ForeName': 'Ekaterina A', 'Initials': 'EA', 'LastName': 'Dokukina', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russia.'}, {'ForeName': 'Ekaterina V', 'Initials': 'EV', 'LastName': 'Chernyaeva', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russia.'}, {'ForeName': 'Roman A', 'Initials': 'RA', 'LastName': 'Ivanov', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russia.'}]",Rheumatology international,['10.1007/s00296-019-04359-9']
802,32147571,A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures.,"BACKGROUND


Cancer-related fatigue is a significant problem and is associated with poor quality of life. Behavioral interventions include exercise and cognitive-behavioral therapy, which survivors may be unwilling or unable to adopt. Pharmacologic interventions (e.g., selective serotonin reuptake inhibitors) have been disappointing. One potential therapy is the antidepressant bupropion, a norepinephrine-dopamine reuptake inhibitor that targets both inflammation and the hypothalamic-pituitary-adrenal axis. The current study is intended to provide a rigorous test of the efficacy and tolerability of bupropion for cancer-related fatigue.
METHODS


A randomized, double-blind, placebo-controlled trial will examine the effects of bupropion on cancer-related fatigue. The trial will be conducted nationwide through the University of Rochester Medical Center (URMC) National Cancer Institute Community Oncology Research Program (NCORP). Disease-free breast cancer survivors (n = 422) who completed chemotherapy and/or radiotherapy 12-60 months previously and report significant fatigue will be randomized 1:1 to receive bupropion (300 mg/day) or placebo. Outcomes will be assessed at baseline and the 12-week follow-up. The primary outcome, fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). Secondary outcomes include quality of life, depression, and drug tolerability. Exploratory outcomes include cognition and symptomatology. Potential biological mechanisms and genetic moderators of cancer-related fatigue will also be explored.
DISCUSSION


This study is the first placebo-controlled trial to our knowledge to evaluate bupropion for cancer-related fatigue. Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.",2020,"Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.","['Disease-free breast cancer survivors (n\xa0=\xa0422) who completed', 'Cancer-related fatigue', 'University of Rochester Medical Center (URMC']","['bupropion', 'placebo', 'chemotherapy', 'Behavioral interventions include exercise and cognitive-behavioral therapy']","['efficacy and tolerability', 'cognition and symptomatology', 'fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F', 'cancer-related fatigue', 'quality of life, depression, and drug tolerability']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",422.0,0.134713,"Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.","[{'ForeName': 'Heather S L', 'Initials': 'HSL', 'LastName': 'Jim', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA. Electronic address: heather.jim@moffitt.org.'}, {'ForeName': 'Aasha I', 'Initials': 'AI', 'LastName': 'Hoogland', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Hyo Sook', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Heckler', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Janelsins', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Williams', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Julienne', 'Initials': 'J', 'LastName': 'Bower', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cole', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Zeruesenay', 'Initials': 'Z', 'LastName': 'Desta', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Margarita Bobonis', 'Initials': 'MB', 'LastName': 'Babilonia', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Morrow', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Peppone', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105976']
803,31097163,Pacemaker Implantation After Mitral Valve Surgery With Atrial Fibrillation Ablation.,"BACKGROUND


The incidence of permanent pacemaker (PPM) implantation is higher following mitral valve surgery (MVS) with ablation for atrial fibrillation (AF) compared with MVS alone.
OBJECTIVES


This study identified risk factors and outcomes associated with PPM implantation in a randomized trial that evaluated ablation for AF in patients who underwent MVS.
METHODS


A total of 243 patients with AF and without previous PPM placement were randomly assigned to MVS alone (n = 117) or MVS + ablation (n = 126). Patients in the ablation group were further randomized to pulmonary vein isolation (PVI) (n = 62) or the biatrial maze procedure (n = 64). Using competing risk models, this study examined the association among PPM and baseline and operative risk factors, and the effect of PPM on time to discharge, readmissions, and 1-year mortality.
RESULTS


Thirty-five patients received a PPM within the first year (14.4%), 29 (83%) underwent implantation during the index hospitalization. The frequency of PPM implantation was 7.7% in patients randomized to MVS alone, 16.1% in MVS + PVI, and 25% in MVS + biatrial maze. The indications for PPM were similar among patients who underwent MVS with and without ablation. Ablation, multivalve surgery, and New York Heart Association functional (NYHA) functional class III/IV were independent risk factors for PPM implantation. Length of stay post-surgery was longer in patients who received PPMs, but it was not significant when adjusted for randomization assignment (MVS vs. ablation) and age (hazard ratio [HR]: 0.81; 95% confidence interval [CI]: 0.61 to 1.08; p = 0.14). PPM implantation did not increase 30-day readmission rate (HR: 1.43; 95% CI: 0.50 to 4.05; p = 0.50). The need for PPM was associated with a higher risk of 1-year mortality (HR: 3.21; 95% CI: 1.01 to 10.17; p = 0.05) after adjustment for randomization assignment, age, and NYHA functional class.
CONCLUSIONS


AF ablation, multivalve surgery, and NYHA functional class III/IV were associated with an increased risk for permanent pacing. PPM implantation following MVS was associated with a significant increase in 1-year mortality. (Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery; NCT00903370).",2019,PPM implantation did not increase 30-day readmission rate (HR: 1.43; 95% CI: 0.50 to 4.05; p = 0.50).,"['243 patients with AF and without previous PPM placement', 'Patients With Atrial Fibrillation', 'patients who underwent MVS']","['MVS\xa0+ ablation', 'pulmonary vein isolation (PVI) (n\xa0=\xa062) or the biatrial maze procedure', 'MVS', 'Pacemaker Implantation', 'permanent pacemaker (PPM) implantation', 'Surgical Ablation Versus No Surgical Ablation', 'PPM implantation', 'mitral valve surgery (MVS', 'MVS alone']","['time to discharge, readmissions, and 1-year mortality', 'frequency of PPM implantation', '30-day readmission rate', 'Ablation, multivalve surgery, and New York Heart Association functional (NYHA) functional class III/IV', '1-year mortality', 'Length of stay post-surgery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0397414', 'cui_str': 'Maze procedure for atrial fibrillation (procedure)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0026264', 'cui_str': 'Bicuspid Valve'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441887', 'cui_str': 'Class 3 (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",243.0,0.0490692,PPM implantation did not increase 30-day readmission rate (HR: 1.43; 95% CI: 0.50 to 4.05; p = 0.50).,"[{'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'DeRose', 'Affiliation': 'Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, New York.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Mancini', 'Affiliation': 'International Center for Health Outcomes and Innovation Research (InCHOIR), the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: donna.mancini@mountsinai.org.'}, {'ForeName': 'Helena L', 'Initials': 'HL', 'LastName': 'Chang', 'Affiliation': 'International Center for Health Outcomes and Innovation Research (InCHOIR), the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Argenziano', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dagenais', 'Affiliation': 'Department of Surgery, Institut de Cardiologie et Pneumologie de Québec, Québec, Canada.'}, {'ForeName': 'Gorav', 'Initials': 'G', 'LastName': 'Ailawadi', 'Affiliation': 'Section of Adult Cardiac Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Louis P', 'Initials': 'LP', 'LastName': 'Perrault', 'Affiliation': 'Department of Surgery, Montreal Heart Institute, Québec, Québec, Canada.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Parides', 'Affiliation': 'Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, New York.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Taddei-Peters', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mack', 'Affiliation': 'Cardiovascular Surgery, Baylor Scott and White Health, Plano, Texas.'}, {'ForeName': 'Donald D', 'Initials': 'DD', 'LastName': 'Glower', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Babatunde A', 'Initials': 'BA', 'LastName': 'Yerokun', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Pavan', 'Initials': 'P', 'LastName': 'Atluri', 'Affiliation': 'Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mullen', 'Affiliation': 'Division of Cardiac Surgery, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': ""Department of Cardiovascular Surgery, Mount Sinai Heart at Saint Luke's, New York, New York.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': ""O'Sullivan"", 'Affiliation': 'International Center for Health Outcomes and Innovation Research (InCHOIR), the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Sledz', 'Affiliation': 'International Center for Health Outcomes and Innovation Research (InCHOIR), the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Tremblay', 'Affiliation': 'Department of Surgery, Institut de Cardiologie et Pneumologie de Québec, Québec, Canada.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Moquete', 'Affiliation': 'International Center for Health Outcomes and Innovation Research (InCHOIR), the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Bart S', 'Initials': 'BS', 'LastName': 'Ferket', 'Affiliation': 'International Center for Health Outcomes and Innovation Research (InCHOIR), the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Moskowitz', 'Affiliation': 'International Center for Health Outcomes and Innovation Research (InCHOIR), the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Iribarne', 'Affiliation': 'Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Annetine C', 'Initials': 'AC', 'LastName': 'Gelijns', 'Affiliation': 'International Center for Health Outcomes and Innovation Research (InCHOIR), the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': ""O'Gara"", 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Eugene H', 'Initials': 'EH', 'LastName': 'Blackstone', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'A Marc', 'Initials': 'AM', 'LastName': 'Gillinov', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.02.062']
804,29644875,"A Single Intra-Articular Injection of Gel-200 for Treatment of Symptomatic Osteoarthritis of the Knee Is More Effective than Phosphate Buffered Saline at 6 Months: A Subgroup Analysis of a Multicenter, Randomized Controlled Trial.","OBJECTIVE


Many clinical trials of viscosupplementation have been conducted, although only the Gel-200 (primary) trial included a different patient population. A subgroup analysis of a multicenter, randomized controlled trial comparing the efficacy of single intra-articular injections of Gel-200 with phosphate buffered saline (PBS) was performed to demonstrate its benefit as treatment of osteoarthritis of the knee in a population similar to those of other reported trials of viscosupplementation.
DESIGN


The subgroup population was defined as patients in the intention-to-treat (ITT) population who met the specified criteria. Changes from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores following treatment with Gel-200 or PBS were derived from a longitudinal model and treatment differences compared between groups at weeks 12 and 26, and over 26 weeks.
RESULTS


The subgroup included 311 subjects (152 Gel-200; 159 PBS). Mean improvements from baseline in WOMAC pain subscores in the Gel-200 over PBS groups were statistically significant at week 12 ( P  = 0.031) and week 26 ( P  = 0.019 ) . Treatment group differences in WOMAC stiffness and total scores were statistically significant at week 26 ( P  = 0.023 and  P  = 0.036, respectively).
CONCLUSIONS


The efficacy of Gel-200 following a single injection for knee osteoarthritis was demonstrated in WOMAC pain, stiffness, and total scores as well as clinically important improvements in pain at 26 weeks in this subset of patients with comparable characteristics to populations evaluated in other viscosupplementation treatment trials.",2019,"Treatment group differences in WOMAC stiffness and total scores were statistically significant at week 26 ( P = 0.023 and P = 0.036, respectively).","['The subgroup included 311 subjects (152 Gel-200; 159 PBS', 'subgroup population was defined as patients in the intention-to-treat (ITT) population who met the specified criteria']","['Gel-200 with phosphate buffered saline (PBS', 'Phosphate Buffered Saline']","['WOMAC pain subscores', 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores', 'WOMAC pain, stiffness, and total scores', 'WOMAC stiffness and total scores']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",311.0,0.456929,"Treatment group differences in WOMAC stiffness and total scores were statistically significant at week 26 ( P = 0.023 and P = 0.036, respectively).","[{'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Takamura', 'Affiliation': 'R&D Planning Department, Research & Development Division, Seikagaku Corporation, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Seo', 'Affiliation': 'Clinical Development Department, Research & Development Division, Seikagaku Corporation, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.'}]",Cartilage,['10.1177/1947603518768015']
805,32225045,Adaptation of a Health Education Program for Improving the Uptake of HIV Self-Testing by Men in Rwanda: A Study Protocol.,"Background and objectives:  Available evidence shows a low uptake of HIV services among men in Rwanda. HIV self-testing (HIVST), a new intervention, may have the potential to improve the uptake of HIV testing services among men. The current study aims to adapt a health education program (HEP) for improving the uptake of HIVST among men in Rwanda.  Materials and Methods : We propose a mixed method study, which will be conducted in four phases. In Phase 1, we will conduct a scoping review to map the available evidence on health education programs for men in low- and middle-income countries (LMICs). In Phase 2, we will conduct interviews with stakeholders in the Rwanda HIV response and healthcare providers to determine their perspectives on implementation of HIVST in Rwanda. In Phase 3, a cross-sectional survey will be used to assess HIVST awareness and acceptability among men in Rwanda. Guided by findings from Phases 1, 2, and 3, we will employ the nominal group technique to develop and optimize the HEP for improving the uptake of HIVST among men in Rwanda. In Phase 4, we will use a pragmatic pilot randomized controlled trial to assess the preliminary impact of the HEP for men in Rwanda and assess the feasibility of a later, larger study. We will employ the Stata version 16 statistical package and NVivo version 12 for the analysis of quantitative and qualitative data, respectively. We anticipate that the findings of this study will inform implementers and policy makers to guide strategies on the implementation of HIVST in Rwanda and ultimately accomplish goals set forth in the Rwanda 2019-2024 Fourth Health Sector Strategic Plan on scaling up the number of men who know their HIV status.  Conclusion:  It is anticipated that this study will proffer solutions and strategies that are applicable not only in Rwanda but also in similar settings of LMICs.",2020,"HIV self-testing (HIVST), a new intervention, may have the potential to improve the uptake of HIV testing services among men.","['men', 'men in low- and middle-income countries (LMICs', 'by Men in Rwanda', 'men in Rwanda']","['Materials and Methods ', 'Health Education Program', 'HEP', 'health education program (HEP', 'HIV self-testing (HIVST']","['HIVST awareness and acceptability', 'Uptake of HIV Self-Testing']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0035978', 'cui_str': 'Ruanda'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0018701'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",,0.0498635,"HIV self-testing (HIVST), a new intervention, may have the potential to improve the uptake of HIV testing services among men.","[{'ForeName': 'Tafadzwa', 'Initials': 'T', 'LastName': 'Dzinamarira', 'Affiliation': 'Department of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban 4001, South Africa.'}, {'ForeName': 'Tivani Phosa', 'Initials': 'TP', 'LastName': 'Mashamba-Thompson', 'Affiliation': 'Department of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban 4001, South Africa.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56040149']
806,30456796,Glycaemic efficacy and safety of linagliptin compared to a basal-bolus insulin regimen in patients with type 2 diabetes undergoing non-cardiac surgery: A multicentre randomized clinical trial.,"AIMS


The use of incretin-based therapy, rather than or complementary to, insulin therapy is an active area of research in hospitalized patients with type 2 diabetes (T2D). We determined the glycaemic efficacy and safety of linagliptin compared to a basal-bolus insulin regimen in hospitalized surgical patients with T2D.
MATERIALS AND METHODS


This prospective open-label multicentre study randomized T2D patients undergoing non-cardiac surgery with admission blood glucose (BG) of 7.8 to 22.2 mmol/L who were under treatment with diet, oral agents or total insulin dose (TDD) ≤ 0.5 units/kg/day to either linagliptin (n = 128) daily or basal-bolus (n = 122) with glargine once daily and rapid-acting insulin before meals. Both groups received supplemental insulin for BG > 7.8 mmol/L. The primary endpoint was difference in mean daily BG between groups.
RESULTS


Mean daily BG was higher in the linagliptin group compared to the basal-bolus group (9.5 ± 2.6 vs 8.8 ± 2.3 mmol/L/dL, P = 0.03) with a mean daily BG difference of 0.6 mmol/L (95% confidence interval 0.04, 1.2). In patients with randomization BG < 11.1 mmol/L (63% of cohort), mean daily BG was similar in the linagliptin and basal-bolus groups (8.9 ± 2.3 vs 8.7 ± 2.3 mmol/L, P = 0.43); however, patients with BG ≥ 11.1 mmol/L who were treated with linagliptin had higher BG compared to the basal-bolus group (10.9 ± 2.6 vs 9.2 ± 2.2 mmol/L, P < 0.001). Linagliptin resulted in fewer hypoglycaemic events (1.6% vs 11%, P = 0.001; 86% relative risk reduction), with similar supplemental insulin and fewer daily insulin injections (2.0 ± 3.3 vs 3.1 ± 3.3, P < 0.001) compared to the basal-bolus group.
CONCLUSIONS


For patients with T2D undergoing non-cardiac surgery who presented with mild to moderate hyperglycaemia (BG < 11.1 mmol/L), daily linagliptin is a safe and effective alternative to multi-dose insulin therapy, resulting in similar glucose control with lower hypoglycaemia.",2019,"Linagliptin resulted in fewer hypoglycaemic events (1.6% vs. 11%, p=0.001, 86% relative risk reduction), similar supplemental insulin (and lower number of daily insulin injections (2.0±3.3 vs 3.1±3.3, p<0.001) compared to basal-bolus.
","['T2D patients undergoing non-cardiac surgery with admission blood glucose(BG) 7.8-22.2 mmol/L treated with diet, oral agents or total insulin dose(TDD) ≤0.5 units/kg/day to linagliptin(n=128) daily or basal-bolus(n=122) with glargine once daily and rapid-acting insulin before meals', 'hospitalized patients with type 2 diabetes (T2D', 'hospitalized surgical patients with T2D', 'patients with T2D undergoing non-cardiac surgery presenting with mild to moderate hyperglycaemia (BG <11.1 mmol/L', 'Patients with Type 2 Diabetes Undergoing Non-Cardiac Surgery']","['linagliptin', 'Linagliptin', 'supplemental insulin', 'incretin-based therapy instead of or complementary to insulin therapy', 'Basal-Bolus Insulin Regimen']","['Mean daily BG', 'mean daily BG', 'hypoglycaemic events', 'supplemental insulin (and lower number of daily insulin injections', 'glycaemic efficacy and safety', 'Glycaemic Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1532634', 'cui_str': 'Unit/kilogram/day'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0356365', 'cui_str': 'Insulin, Rapid-Acting'}, {'cui': 'C1550738', 'cui_str': 'Before meal (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0586328', 'cui_str': 'Insulin injection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.107985,"Linagliptin resulted in fewer hypoglycaemic events (1.6% vs. 11%, p=0.001, 86% relative risk reduction), similar supplemental insulin (and lower number of daily insulin injections (2.0±3.3 vs 3.1±3.3, p<0.001) compared to basal-bolus.
","[{'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Rasouli', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado-Denver, Denver, Colorado.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baldwin', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Alexanian', 'Affiliation': 'Division of Endocrinology, Diabetes and Nutrition, Department of Medicine, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Anzola', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Urrutia', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Biostatistics, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13587']
807,30343489,"Automated symptom and treatment side effect monitoring for improved quality of life among adults with diabetic peripheral neuropathy in primary care: a pragmatic, cluster, randomized, controlled trial.","AIMS


To evaluate the effectiveness of automated symptom and side effect monitoring on quality of life among individuals with symptomatic diabetic peripheral neuropathy.
METHODS


We conducted a pragmatic, cluster randomized controlled trial (July 2014 to July 2016) within a large healthcare system. We randomized 1834 primary care physicians and prospectively recruited from their lists 1270 individuals with neuropathy who were newly prescribed medications for their symptoms. Intervention participants received automated telephone-based symptom and side effect monitoring with physician feedback over 6 months. The control group received usual care plus three non-interactive diabetes educational calls. Our primary outcomes were quality of life (EQ-5D) and select symptoms (e.g. pain) measured 4-8 weeks after starting medication and again 8 months after baseline. Process outcomes included receiving a clinically effective dose and communication between individuals with neuropathy and their primary care provider over 12 months. Interviewers collecting outcome data were blinded to intervention assignment.
RESULTS


Some 1252 participants completed the baseline measures [mean age (sd): 67 (11.7), 53% female, 57% white, 8% Asian, 13% black, 20% Hispanic]. In total, 1179 participants (93%) completed follow-up (619 control, 560 intervention). Quality of life scores (intervention: 0.658 ± 0.094; control: 0.653 ± 0.092) and symptom severity were similar at baseline. The intervention had no effect on primary [EQ-5D: -0.002 (95% CI -0.01, 0.01), P = 0.623; pain: 0.295 (-0.75, 1.34), P = 0.579; sleep disruption: 0.342 (-0.18, 0.86), P = 0.196; lower extremity functioning: -0.079 (-1.27, 1.11), P = 0.896; depression: -0.462 (-1.24, 0.32); P = 0.247] or process outcomes.
CONCLUSIONS


Automated telephone monitoring and feedback alone were not effective at improving quality of life or symptoms for people with symptomatic diabetic peripheral neuropathy.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02056431).",2019,"depression: -0.462 (-1.24, 0.32); P = 0.247] or process outcomes.
","['adults with diabetic peripheral neuropathy in primary care', 'people with symptomatic diabetic peripheral neuropathy', '1179 participants (93%) completed follow-up (619 control, 560 intervention', 'individuals with symptomatic diabetic peripheral neuropathy', '1252 participants completed the baseline measures [mean age (sd): 67 (11.7), 53% female, 57% white, 8% Asian, 13% black, 20% Hispanic', '1834 primary care physicians and prospectively recruited from their lists 1270 individuals with neuropathy who were newly prescribed medications for their symptoms', 'July 2014 to July 2016) within a large healthcare system']","['usual care plus three non-interactive diabetes educational calls', 'automated telephone-based symptom and side effect monitoring with physician feedback']","['Quality of life scores', 'quality of life or symptoms', 'symptom severity', 'quality of life', 'quality of life (EQ-5D) and select symptoms (e.g. pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517535', 'cui_str': '11.7 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",1834.0,0.227587,"depression: -0.462 (-1.24, 0.32); P = 0.247] or process outcomes.
","[{'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Adams', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, CA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, CA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Altschuler', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, CA.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Bayliss', 'Affiliation': 'Kaiser Permanente Colorado Institute for Health Research, Denver, CO.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Neugebauer', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, CA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, CA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Dyer', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, CA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Clark', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, CA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cook', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, CA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Willyoung', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, CA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jaffe', 'Affiliation': 'Kaiser Permanente South San Francisco Medical Center, South San Francisco, CA.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': 'Kaiser Permanente Oakland Medical Center, Oakland, CA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Kaiser Permanente Oakland Medical Center, Oakland, CA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Boggs', 'Affiliation': 'Kaiser Permanente Colorado Institute for Health Research, Denver, CO.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Prosser', 'Affiliation': 'University of Michigan, School of Public Health, Ann Arbor, MI.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wittenberg', 'Affiliation': 'Harvard School of Public Health, Boston, MA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Callaghan', 'Affiliation': 'University of Michigan, Michigan Medicine, Neurology Clinic, Ann Arbor, MI, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shainline', 'Affiliation': 'Kaiser Permanente Colorado Institute for Health Research, Denver, CO.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Hippler', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, CA.'}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Grant', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, CA.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.13840']
808,32150758,Comparing TEE- vs Non-TEE-guided cardioversion of atrial fibrillation: The ENSURE-AF trial.,"BACKGROUND


ENSURE-AF (NCT02072434) assessed therapy with edoxaban vs enoxaparin-warfarin in patients with nonvalvular atrial fibrillation (AF) undergoing elective electrical cardioversion (ECV).
OBJECTIVES


To evaluate clinical features and primary efficacy (composite of stroke, systemic embolic events, myocardial infarction and cardiovascular mortality during study period) and safety endpoints (composite of major and clinically relevant nonmajor bleeding during on-treatment period) in patients awaiting ECV of AF with a transesophageal echocardiography (TEE)-guided vs a non-TEE-guided strategy.
METHODS


In this prospective, randomized, open-label, blinded endpoint study, 2199 patients were randomized to edoxaban 60 mg once-daily (30 mg for creatinine clearance 15-50 mL/min, weight ≤60 kg and/or concomitant use of P-glycoprotein inhibitor) or enoxaparin-warfarin. Primary efficacy endpoint and safety endpoint were reported. Associates of TEE use, efficacy endpoint and safety endpoint were explored using multivariable logistic regression.
RESULTS


In total, 589 patients from the edoxaban stratum and 594 from the enoxaparin-warfarin stratum were allocated to the TEE-guided strategy. Primary efficacy was similar regardless of TEE approach (P = .575). There were no significant differences in bleeding rates, regardless of TEE approach (P = .677). Independent predictors of TEE use were as follows: history of ischaemic stroke/ transient ischaemic attack, hypertension and valvular heart disease. Mean CHA 2  DS 2  VASc and HAS-BLED score were independent predictors of the efficacy endpoint whilst mean age was an independent predictor of the safety endpoint.
CONCLUSIONS


Thromboembolic and bleeding events were not different between patients undergoing TEE-guided strategy and in those undergoing an optimized conventional anticoagulation approach for ECV of AF.",2020,Mean CHA 2  DS 2  VASc and HAS-BLED score were independent predictors of the efficacy endpoint,"['patients with nonvalvular atrial fibrillation (AF) undergoing elective electrical cardioversion (ECV', '2199 patients', 'patients awaiting ECV of AF with a', '589 patients from the edoxaban stratum and 594 from the enoxaparin-warfarin stratum']","['TEE', 'enoxaparin-warfarin', 'transesophageal echocardiography (TEE)-guided versus a non-TEE guided strategy', 'TEE-guided strategy', 'edoxaban 60 mg once daily (30 mg for creatinine clearance 15-50 mL/min, weight ≤60 kg, and/or concomitant use of P-glycoprotein inhibitor) or enoxaparin-warfarin', 'edoxaban']","['ischaemic stroke/ transient ischaemic attack, hypertension and valvular heart disease', 'Thromboembolic and bleeding events', 'clinical features and primary efficacy (composite of stroke, systemic embolic events, myocardial infarction and cardiovascular mortality', 'Mean CHA 2  DS 2  VASc and HAS-BLED score', 'bleeding rates, regardless of TEE approach']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0206054', 'cui_str': 'Echocardiography, Transesophageal'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3872158', 'cui_str': 'edoxaban 60 MG [Savaysa]'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0242643', 'cui_str': 'ATP Binding Cassette Transporter, Sub-Family B, Member 1'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0018824', 'cui_str': 'Valvular Heart Diseases'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3875442', 'cui_str': 'HAS-BLED score'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",2199.0,0.0580301,Mean CHA 2  DS 2  VASc and HAS-BLED score were independent predictors of the efficacy endpoint,"[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Kozieł', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Merino', 'Affiliation': 'Arrhythmia and Robotic Electrophysiology Unit, Hospital Universitario La Paz, Universidad Europea, Madrid, Spain.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caterina', 'Affiliation': 'Institute of Cardiology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital, Medical School, Sigmund Freud University, Vienna, Austria.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Daiichi Sankyo, Inc., Basking Ridge, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Melino', 'Affiliation': 'Daiichi Sankyo, Inc., Basking Ridge, NJ, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goette', 'Affiliation': 'St. Vincenz-Hospital, Paderborn, Paderborn, Germany and Working Group: Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of clinical investigation,['10.1111/eci.13221']
809,32222267,Pain Control After Total Hip Arthroplasty: A Randomized Controlled Trial Determining Efficacy of Fascia Iliaca Compartment Blocks in the Immediate Postoperative Period.,"BACKGROUND


The purpose of this randomized controlled trial is to identify if a fascia iliaca block reduces postoperative pain and narcotic consumption and improves early functional outcomes in primary total hip arthroplasty (THA) performed through the mini-posterior approach.
METHODS


Patients were recruited from September 2017 to September 2019. Eligible patients received a primary THA using a mini-posterior approach with epidural anesthesia. Postoperatively, patients were randomized to receive a fascia iliaca compartment block or a placebo block. Numeric Rating Scale pain scores, narcotic consumption, and functional outcomes were recorded at regular intervals postoperatively.
RESULTS


Upon study completion, 122 patients were available for final analysis. There was no difference in the average pain scores at any time interval between the placebo and block groups during the first 24 hours (P = .21-.99). There was no difference in the morphine equivalents consumed between the groups during any time interval postoperatively (P = .06-.95). Functional testing showed no difference in regards to distance walked during the first therapy session (67.1 vs 68.3 ft., P = .92) and timed-up-and-go testing (63.7 vs 66.3 seconds, P = .86). There was an increased incidence of quadriceps weakness in the block group (22% vs 0%, P = .004) requiring alterations in therapy protocols.
CONCLUSION


This randomized trial shows that a fascia iliaca compartment block does not improve functional performance and does not decrease pain levels or narcotic usage after mini-posterior THA, but does increase the risk of quadriceps weakness postoperatively. Based on these results we do not recommend routine fascia iliaca compartment blocks after THA performed with the mini-posterior approach.",2020,There was no difference in the morphine equivalents consumed between the groups during any time interval postoperatively (P = .06-.95).,"['primary total hip arthroplasty (THA', 'After Total Hip Arthroplasty', '122 patients were available for final analysis', 'Patients were recruited from September 2017 to September 2019']","['primary THA using a mini-posterior approach with epidural anesthesia', 'placebo', 'Fascia Iliaca Compartment Blocks', 'fascia iliaca compartment block or a placebo block']","['pain levels or narcotic usage', 'average pain scores', 'morphine equivalents', 'Pain Control', 'postoperative pain and narcotic consumption', 'functional performance', 'incidence of quadriceps weakness', 'Numeric Rating Scale pain scores, narcotic consumption, and functional outcomes']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach (qualifier value)'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3853978'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714552', 'cui_str': 'Weakness - general'}, {'cui': 'C0222045'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",122.0,0.282413,There was no difference in the morphine equivalents consumed between the groups during any time interval postoperatively (P = .06-.95).,"[{'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Bober', 'Affiliation': 'Department of Orthopedic Surgery, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Kadado', 'Affiliation': 'Department of Orthopedic Surgery, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Charters', 'Affiliation': 'Department of Orthopedic Surgery, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Ayooluwa', 'Initials': 'A', 'LastName': 'Ayoola', 'Affiliation': 'Department of Orthopedic Surgery, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'North', 'Affiliation': 'Department of Orthopedic Surgery, Henry Ford Hospital, Detroit, MI.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.02.020']
810,32222326,Impacting child health outcomes in congenital heart disease: Cluster randomized controlled trial protocol of in-clinic physical activity counselling.,"BACKGROUND


Most (>90%) children with congenital health defects are not active enough for optimal health. Proactively promoting physical activity during every clinic visit is recommended, but rarely implemented due to a lack of appropriate resources.
METHODS


This cluster randomized controlled trial will implement an evidence-based, multi-faceted physical activity intervention. All eligible patients at small (London, ON), medium (Ottawa, ON) and large (Edmonton, AB) pediatric cardiac clinics will be approached, with randomization to intervention/control by clinic and week. Intervention patients will be counselled with 5 key physical activity messages, have questions about physical activity answered, and have access to a custom web site with personalized activity suggestions and support from a Registered Kinesiologist. The primary outcome is daily physical activity (number of steps, minutes of moderate-to-vigorous activity) assessed via pedometer one week per month for 6-months. Standardized questionnaires assess activity motivation and quality of life at baseline and end of study. Healthcare outcomes will be clinic visit time and contacts for physical activity concerns. Repeated measures ANCOVA will compare control/intervention pedometer outcomes, adjusting for covariates (alpha=0.05).
CONCLUSIONS


This trial aims to determine whether providing resources and protocols enables clinicians to counsel about physical activity as part of every pediatric cardiology appointment. Evaluations of healthcare system impact and intervention delivery in small, medium and large clinics will assess applicability for implementation in all pediatric cardiac clinics. The impact on physical activity motivation and participation will evaluate the effectiveness of this standardized approach for increasing physical activity in children with congenital heart defects.",2020,"Evaluations of healthcare system impact and intervention delivery in small, medium and large clinics will assess applicability for implementation in all pediatric cardiac clinics.","['children with congenital health defects', 'Most (>90%) children with congenital health defects', 'all pediatric cardiac clinics', 'All eligible patients at small (London, ON), medium (Ottawa, ON) and large (Edmonton, AB) pediatric cardiac clinics', 'congenital heart disease']",['clinic physical activity counselling'],"['daily physical activity (number of steps, minutes of moderate-to-vigorous activity) assessed via pedometer one week per month for 6-months', 'Standardized questionnaires assess activity motivation and quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0439083', 'cui_str': '>90 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0034380'}]",,0.168498,"Evaluations of healthcare system impact and intervention delivery in small, medium and large clinics will assess applicability for implementation in all pediatric cardiac clinics.","[{'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Lemire', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada; University of Ottawa, Faculty of Medicine, Ottawa, Ontario, Canada.""}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Yaraskavitch', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lougheed', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada; Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mackie', 'Affiliation': ""Stollery Children's Hospital, Department of Pediatrics, Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Norozi', 'Affiliation': ""Department of Pediatrics, Pediatric Cardiology, Schulich School of Medicine and Dentistry, Western University & Children's Health Research Institute, London, Ontario, Canada; Paediatric Cardiology and Intensive Care Medicine, Medical School Hannover, Germany.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': 'Canadian Congenital Heart Alliance, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Willan', 'Affiliation': 'The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Longmuir', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada; University of Ottawa, Faculty of Medicine, Ottawa, Ontario, Canada. Electronic address: plongmuir@cheo.on.ca.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.105994']
811,32221696,Differences in acute reinforcement across reduced nicotine content cigarettes.,"RATIONALE


The smallest difference in nicotine that can change a smoker's cigarette preference is not clearly known.
OBJECTIVE


A procedure to efficiently identify the difference in nicotine needed to change cigarette preference could help inform research to gauge effects of a nicotine reduction policy.
METHODS


Using a within-subject design, we assessed preference for research cigarettes varying in nicotine contents (NIC; 18.7, 10.8, 5.3, 2.3, and 1.3 mg/g of tobacco), relative to a very low nicotine cigarette (VLNC; 0.4 mg/g), in 17 adult-dependent non-menthol smokers abstinent overnight. Only one NIC was compared vs. the VLNC per session, with order of the five NIC contents randomized across sessions on five separate days. Preference for each NIC vs. VLNC was determined by validated forced choice procedure, with those NIC chosen more than VLNC indicating greater reinforcement due to greater nicotine per se. Secondarily, less preference for lower NIC (vs. VLNC), relative to choice for the highest NIC, 18.7 mg/g (vs. VLNC), indexed reduced reinforcement.
RESULTS


Overall, NIC choices increased as their nicotine increased, as anticipated. Relative to the 0.4 mg/g VLNC, choice was greater for NIC ≥ 5.3 mg/g but not ≤ 2.3 mg/g. Correspondingly, relative to choice for 18.7 mg/g, choice was less for NIC ≤ 2.3 mg/g but not ≥ 5.3 mg/g.
CONCLUSIONS


Although replication with larger samples and longer access is needed, results indicate that nicotine reduction to ≤ 2.3 mg/g in cigarettes would attenuate reinforcement. This choice procedure may efficiently inform future clinical trials to assess relative reinforcing effects of smoking reduced nicotine cigarettes.",2020,"VLNC, choice was greater for NIC ≥ ",['17 adult-dependent non-menthol smokers abstinent overnight'],"['nicotine', 'mg/g of tobacco', 'low nicotine cigarette (VLNC']","['Overall, NIC choices']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}]",17.0,0.0328602,"VLNC, choice was greater for NIC ≥ ","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Perkins', 'Affiliation': ""Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, 3811 O'Hara Street, Pittsburgh, PA, 15213, USA. perkinska@upmc.edu.""}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Karelitz', 'Affiliation': ""Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, 3811 O'Hara Street, Pittsburgh, PA, 15213, USA.""}]",Psychopharmacology,['10.1007/s00213-020-05509-9']
812,30664239,Deprescribing in the Pharmacologic Management of Delirium: A Randomized Trial in the Intensive Care Unit.,"OBJECTIVE


Benzodiazepines and anticholinergics are risk factors for delirium in the intensive care unit (ICU). We tested the impact of a deprescribing intervention on short-term delirium outcomes.
DESIGN


Multisite randomized clinical trial.
SETTING


ICUs of three large hospitals.
PARTICIPANTS


Two hundred adults aged 18 years or older and admitted to an ICU with delirium, according to the Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the ICU (CAM-ICU). Participants had a contraindication to haloperidol (seizure disorder or prolonged QT interval) or preference against haloperidol as a treatment for delirium, and were excluded for serious mental illness, stroke, pregnancy, or alcohol withdrawal. Participants were randomized to a deprescribing intervention or usual care. The intervention included electronic alerts combined with pharmacist support to deprescribe anticholinergics and benzodiazepines.
MEASUREMENTS


Primary outcomes were delirium duration measured by the CAM-ICU and severity measured by the Delirium Rating Scale Revised-98 (DRS-R-98) and the CAM-ICU-7; secondary outcomes included adverse events and mortality.
RESULTS


Participants had a mean age of 61.8 (SD = 14.3) years, 59% were female, and 52% were African American, with no significant differences in baseline characteristics between groups. No differences between groups were identified in the number exposed to anticholinergics (P = .219) or benzodiazepines (P = .566), the median total anticholinergic score (P = .282), or the median total benzodiazepine dose in lorazepam equivalents (P = .501). Neither median delirium/coma-free days (P = .361) nor median change in delirium severity scores (P = .582 for DRS-R-98; P = .333 for CAM-ICU-7) were different between groups. No differences in adverse events or mortality were identified.
CONCLUSIONS


When added to state-of-the-art clinical services, this deprescribing intervention had no impact on medication use in ICU participants. Given the age of the population, results of clinical outcomes may not be easily extrapolated to older adults. Nonetheless, improved approaches for deprescribing or preventing anticholinergics and benzodiazepines should be developed to determine the impact on delirium outcomes. J Am Geriatr Soc 67:695-702, 2019.",2019,"No differences between groups were identified in the number exposed to anticholinergics (P = .219) or benzodiazepines (P = .566), the median total anticholinergic score (P = .282), or the median total benzodiazepine dose in lorazepam equivalents (P = .501).","['Delirium', 'Two hundred adults aged 18 years or older and admitted to an ICU with delirium, according to the Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the ICU (CAM-ICU', 'Participants had a contraindication to haloperidol (seizure disorder or prolonged QT interval) or preference against haloperidol as a treatment for delirium, and were excluded for serious mental illness, stroke, pregnancy, or alcohol withdrawal', 'ICUs of three large hospitals']","['Benzodiazepines and anticholinergics', 'deprescribing intervention or usual care', 'deprescribing intervention', 'electronic alerts combined with pharmacist support to deprescribe anticholinergics and benzodiazepines', 'benzodiazepines']","['delirium duration measured by the CAM-ICU and severity measured by the Delirium Rating Scale Revised-98 (DRS-R-98) and the CAM-ICU-7; secondary outcomes included adverse events and mortality', 'delirium severity scores', 'median total anticholinergic score', 'adverse events or mortality', 'median total benzodiazepine dose in lorazepam equivalents']","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval (finding)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C4046040', 'cui_str': 'Deprescribing'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]",200.0,0.137567,"No differences between groups were identified in the number exposed to anticholinergics (P = .219) or benzodiazepines (P = .566), the median total anticholinergic score (P = .282), or the median total benzodiazepine dose in lorazepam equivalents (P = .501).","[{'ForeName': 'Noll L', 'Initials': 'NL', 'LastName': 'Campbell', 'Affiliation': 'Purdue University College of Pharmacy, West Lafayette, Indiana.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Perkins', 'Affiliation': 'Indiana University Center for Health Innovation and Implementation Science and Indiana Clinical and Translational Sciences Institute, Indianapolis, Indiana.'}, {'ForeName': 'Babar A', 'Initials': 'BA', 'LastName': 'Khan', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, Indiana.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, Indiana.'}, {'ForeName': 'Mark O', 'Initials': 'MO', 'LastName': 'Farber', 'Affiliation': 'Department of Medicine Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Sikandar', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, Indiana.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Malaz A', 'Initials': 'MA', 'LastName': 'Boustani', 'Affiliation': 'Indiana University Center for Aging Research, Indianapolis, Indiana.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15751']
813,32223444,Risk/Benefit Tradeoff of Antithrombotic Therapy in Patients With Atrial Fibrillation Early and Late After an Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From AUGUSTUS.,"BACKGROUND


In AUGUSTUS (Open-Label, 2×2 Factorial, Randomized, Controlled Clinical Trial to Evaluate the Safety of Apixaban vs Vitamin K Antagonist and Aspirin vs Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome and/or Percutaneous Coronary Intervention), patients with atrial fibrillation and a recent acute coronary syndrome and those undergoing percutaneous coronary intervention had less bleeding with apixaban than vitamin K antagonist (VKA) and with placebo than aspirin. However, the number of ischemic events was numerically higher with placebo. The aim of this analysis is to assess the tradeoff of risk (bleeding) and benefit (ischemic events) over time with apixaban versus VKA and aspirin versus placebo.
METHODS


In AUGUSTUS, 4614 patients with atrial fibrillation and recent acute coronary syndrome or percutaneous coronary intervention on a P2Y 12  inhibitor were randomized to blinded aspirin or placebo and to open-label apixaban or VKA for 6 months. In a post hoc analysis, we compared the risk of 3 composite bleeding outcomes and 3 composite ischemic outcomes from randomization through 30 days and from 30 days to 6 months with apixaban and VKA and with aspirin and placebo.
RESULTS


Compared with VKA, apixaban had either a lower or a similar risk of bleeding and ischemic outcomes from randomization to 30 days and from 30 days to 6 months. From randomization to 30 days, aspirin caused more severe bleeding (absolute risk difference, 0.97% [95% CI, 0.23-1.70]) and fewer severe ischemic events (absolute risk difference, -0.91% [95% CI, -1.74 to -0.08]) than placebo. From 30 days to 6 months, the risk of severe bleeding was higher with aspirin than placebo (absolute risk difference, 1.25% [95% CI, 0.23-2.27]), whereas the risk of severe ischemic events was similar (absolute risk difference, -0.17% [95% CI, -1.33 to 0.98]).
CONCLUSIONS


In patients with atrial fibrillation and recent acute coronary syndrome or percutaneous coronary intervention receiving a P2Y 12  inhibitor, apixaban is preferred over VKA. Use of aspirin immediately and for up to 30 days results in an equal tradeoff between an increase in severe bleeding and a reduction in severe ischemic events. After 30 days, aspirin continues to increase bleeding without significantly reducing ischemic events. These results inform shared, patient-centric decision making on the ideal duration of the use of aspirin after an acute coronary syndrome or percutaneous coronary intervention in patients with atrial fibrillation receiving oral anticoagulation. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02415400.",2020,"From randomization to 30 days, aspirin caused more severe bleeding (absolute risk difference 0.97%, 95% CI 0.23 to 1.70) and fewer severe ischemic events (absolute risk difference -0.91%, 95% CI -1.74 to -0.08) than placebo.","['patients with atrial fibrillation (AF) and a recent acute coronary syndrome (ACS) and/or those undergoing', 'Patients with Atrial Fibrillation', 'patients with AF receiving oral anticoagulation', '4614 patients with AF and recent ACS and/or PCI on a P2Y 12  inhibitor']","['vitamin K antagonist (VKA', 'aspirin', 'placebo', 'Antithrombotic Therapy', 'VKA, apixaban', 'aspirin and placebo', 'aspirin or placebo and to open-label apixaban or VKA', 'percutaneous coronary intervention (PCI', 'apixaban versus VKA and aspirin versus placebo', 'Percutaneous Coronary Intervention']","['severe bleeding', 'risk of severe ischemic events', 'risk of severe bleeding', 'severe ischemic events', 'tradeoff of risk (bleeding) and benefit (ischemic events', 'ischemic events', 'risk of bleeding and ischemic outcomes', 'severe bleeding and reduction in severe ischemic events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",4614.0,0.142368,"From randomization to 30 days, aspirin caused more severe bleeding (absolute risk difference 0.97%, 95% CI 0.23 to 1.70) and fewer severe ischemic events (absolute risk difference -0.91%, 95% CI -1.74 to -0.08) than placebo.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (J.H.A., D.W., L.T., C.B.G., R.D.L.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (J.H.A., D.W., L.T., C.B.G., R.D.L.).'}, {'ForeName': 'Amit N', 'Initials': 'AN', 'LastName': 'Vora', 'Affiliation': 'UPMC Pinnacle, Harrisburg, PA (A.N.V.).'}, {'ForeName': 'Laine', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (J.H.A., D.W., L.T., C.B.G., R.D.L.).'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (J.H.A., D.W., L.T., C.B.G., R.D.L.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (S.G.G.).'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ (R.A.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Bern University Hospital, Inselspital, University of Bern, Switzerland (S.W.).'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York, NY (R.M.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (J.H.A., D.W., L.T., C.B.G., R.D.L.).'}]",Circulation,['10.1161/CIRCULATIONAHA.120.046534']
814,32223446,Peripheral Artery Disease and Venous Thromboembolic Events After Acute Coronary Syndrome: Role of Lipoprotein(a) and Modification by Alirocumab: Prespecified Analysis of the ODYSSEY OUTCOMES Randomized Clinical Trial.,"BACKGROUND


Patients with acute coronary syndrome are at risk for peripheral artery disease (PAD) events and venous thromboembolism (VTE). PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors reduce lipoprotein(a) and low-density lipoprotein cholesterol (LDL-C) levels. Our objective was to ascertain whether PCSK9 inhibition reduces the risk of PAD events or VTE after acute coronary syndrome, and if such effects are related to levels of lipoprotein(a) or LDL-C.
METHODS


This was a prespecified analysis of the ODYSSEY OUTCOMES randomized clinical trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome), which was conducted in 18 924 patients with recent acute coronary syndrome on intensive or maximum-tolerated statin treatment who were randomized to the PCSK9 inhibitor alirocumab or placebo. In a prespecified analysis, PAD events (critical limb ischemia, limb revascularization, or amputation for ischemia) and VTE (deep vein thrombosis or pulmonary embolism) were assessed. LDL-C was corrected (LDL-C corrected ) for cholesterol content in lipoprotein(a).
RESULTS


At baseline, median lipoprotein(a) and LDL-C corrected  were 21 and 75 mg/dL, respectively; with alirocumab, median relative reductions were 23.5% and 70.6%, respectively. PAD events and VTE occurred in 246 and 92 patients, respectively. In the placebo group, risk of PAD events was related to baseline quartile of lipoprotein(a) ( P trend =0.0021), and tended to associate with baseline quartile of LDL-C corrected  ( P trend =0.06); VTE tended to associate with baseline quartile of lipoprotein(a) ( P trend =0.06), but not LDL-C corrected  ( P trend =0.85). Alirocumab reduced risk of PAD events (hazard ratio [HR], 0.69 [95% CI, 0.54-0.89];  P =0.004), with nonsignificantly fewer VTE events (HR, 0.67 [95% CI, 0.44-1.01];  P =0.06). Reduction in PAD events with alirocumab was associated with baseline quartile of lipoprotein(a) ( P trend =0.03), but not LDL-C corrected  ( P trend =0.50). With alirocumab, the change from baseline to Month 4 in lipoprotein(a), but not LDL-C corrected , was associated with the risk of VTE and the composite of VTE and PAD events.
CONCLUSIONS


In statin-treated patients with recent acute coronary syndrome, risk of PAD events is related to lipoprotein(a) level and is reduced by alirocumab, particularly among those with high lipoprotein(a). Further study is required to confirm whether risk of VTE is related to lipoprotein(a) level and its reduction with alirocumab. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01663402.",2020,"Alirocumab reduced risk of PAD events (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.54-0.89;  P =0.004), with non-significantly fewer VTE events (HR, 0.67; 95% CI, 0.44-1.01;  P =0.06).","['Patients with acute coronary syndrome (ACS', '18 924 patients with recent ACS on intensive or maximum-tolerated statin treatment who were randomized to the']","['Alirocumab', 'PCSK9 inhibitor alirocumab or placebo', 'placebo', 'PCSK9 inhibition']","['PAD events', 'lipoprotein(a) and low-density lipoprotein cholesterol (LDL-C) levels', 'PAD events and VTE', 'risk of VTE and the composite of VTE and PAD events', 'peripheral artery disease (PAD) events and venous thromboembolism (VTE', 'VTE events', 'median lipoprotein(a) and LDL-C corrected', 'Peripheral Artery Disease and Venous Thromboembolic Events', 'PAD events (critical limb ischemia, limb revascularization, or amputation for ischemia) and VTE (deep vein thrombosis or pulmonary embolism', 'risk of PAD events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4522007', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 inhibitor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0472662', 'cui_str': 'Limb revascularization (procedure)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}]",18924.0,0.568608,"Alirocumab reduced risk of PAD events (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.54-0.89;  P =0.004), with non-significantly fewer VTE events (HR, 0.67; 95% CI, 0.44-1.01;  P =0.06).","[{'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora (G.G.S.).'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France (P.G.S.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn (M.S.).'}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'University of Alabama at Birmingham (V.A.B.).'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Cardiológicos Latinoamérica, Instituto Cardiovascular de Rosario, Argentina (R.D.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (S.G.G.).'}, {'ForeName': 'Yong-Un', 'Initials': 'YU', 'LastName': 'Kim', 'Affiliation': 'Sanofi, Paris, France (Y.-U.K.).'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Leiden University Medical Center, The Netherlands (J.W.J.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY (R.P.).'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R.).'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services Auckland City Hospital, New Zealand (H.D.W.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.046524']
815,31540617,Integrated stepped alcohol treatment for patients with HIV and liver disease: A randomized trial.,"BACKGROUND


There is no known safe level of alcohol use among patients with HIV and liver disease. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use, HIV, and liver outcomes among patients with HIV and liver disease.
METHODS


In this multi-site, randomized trial conducted between January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score > 1.45]. ISAT (n = 49) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 46) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat.
RESULTS


Among ISAT participants, 55% advanced to Step 2, among whom 70% advanced to Step 3. Participants randomized to ISAT and TAU increased abstinence (primary outcome) over time. Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24. VACS Index scores (AMD [95% CI] = 1.1 [-3.2, 5.5]) and the proportion with an undetectable HIV viral load (AOR [95% CI] = 0.3 [0.1, 1.3]) did not differ by group at week 24 (p values >0.05). ISAT had non-significantly lower FIB-4 scores (adjusted mean difference [AMD] [95% CI] = -0.2 [-0.9, 0.5]), ALT (AMD [95% CI] = -7 [-20, 7]) and AST (AMD [95% CI] = -4 [-15, 7]) at week 24 compared to TAU.
CONCLUSION


ISAT is feasible and potentially effective at enhancing delivery of evidence-based alcohol treatment to promote alcohol abstinence and improve liver biomarkers among patients with HIV and liver disease.",2019,"Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24.","['patients with HIV and liver disease', 'January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score\u202f>\u202f1.45']","['ISAT', 'Integrated stepped alcohol treatment', 'health handout plus routine care', 'integrated stepped alcohol treatment (ISAT', 'ISAT and TAU']","['liver biomarkers', 'Abstinence rates', 'proportion with an undetectable HIV viral load', 'alcohol use, HIV, and liver outcomes', 'VACS Index scores', 'FIB-4 scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517505', 'cui_str': '1.45'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",95.0,0.155409,"Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24.","[{'ForeName': 'E Jennifer', 'Initials': 'EJ', 'LastName': 'Edelman', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America. Electronic address: ejennifer.edelman@yale.edu.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'Syracuse University, Syracuse, NY 13244, United States of America.'}, {'ForeName': 'Nathan B', 'Initials': 'NB', 'LastName': 'Hansen', 'Affiliation': 'Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America; College of Public Health, University of Georgia, Athens, GA 30602, United States of America.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Cutter', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale Center for Analytic Sciences, Yale School of Public Health, New Haven, CT 06511, United States of America.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Yale Center for Analytic Sciences, Yale School of Public Health, New Haven, CT 06511, United States of America.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': ""O'Connor"", 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bedimo', 'Affiliation': 'Veterans Affairs North Texas Health Care System, UT Southwestern, Dallas, TX 75216, United States of America.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Gibert', 'Affiliation': 'D.C. VAMC, George Washington University School of Medicine and Health Sciences, Washington, DC 20422, United States of America.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Atlanta VAMC, Emory University School of Medicine, Atlanta, GA 30033, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rimland', 'Affiliation': 'Atlanta VAMC, Emory University School of Medicine, Atlanta, GA 30033, United States of America.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Rodriguez-Barradas', 'Affiliation': 'Michael E. DeBakey VAMC, Baylor College of Medicine, Houston, TX 77030, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Simberkoff', 'Affiliation': 'VA NY Harbor Healthcare System, New York University School of Medicine, New York, NY 10010, United States of America.'}, {'ForeName': 'Janet P', 'Initials': 'JP', 'LastName': 'Tate', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Justice', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; VA Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT 06516, United States of America.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism HIV/AIDS Program, Bethesda, MD 20892-7003, United States of America.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.007']
816,30798376,The effect of male involvement and a prevention of mother-to-child transmission (PMTCT) intervention on depressive symptoms in perinatal HIV-infected rural South African women.,"This study investigated perinatal depressive symptoms among HIV-infected women enrolled in a cluster-randomized, controlled trial in South Africa. Women (n = 1370) attending 12 community health centers were consecutively enrolled in a two-phase (phase 1 = without a male partner, phase 2 = with a male partner) and two-condition (experimental or control) prevention of mother-to-child transmission (PMTCT) intervention. Women were enrolled at 8-24 weeks pregnant and followed postpartum at 6 weeks and 6 and 12 months (retention rate = 69.8%). Antenatally, 45.4% of women were above the 12-point Edinburgh Postnatal Depression Scale (EPDS) cutoff, 30.2% were above the cutoff at 6 weeks, and 34.2% and 36.9% at 6 months and 12 months postpartum, respectively. In multilevel regression analyses, depressive symptoms decreased over time among women in phase 2 participating in the intervention condition, but neither condition nor phase alone was associated with a decrease in depression. Greater HIV stigma, increased psychological intimate partner violence, less male involvement, lower education, and non-adherence during pregnancy were associated with increased depressive symptoms over the perinatal period. Results indicated that women participating had high levels of depressive symptoms (> 40% prenatally and > 30% postnatally), and the combination of the multi-session PMTCT intervention plus male partner participation contributed to a reduction in depressive symptoms. Results suggest that interventions targeting the reduction of depressive symptoms in perinatal HIV-positive women by increasing male involvement and decreasing HIV stigma and intimate partner violence are needed to reduce depression in this vulnerable population.",2020,"Antenatally, 45.4% of women were above the 12-point Edinburgh Postnatal Depression Scale (EPDS) cutoff, 30.2% were above the cutoff at 6 weeks, and 34.2% and 36.9% at 6 months and 12 months postpartum, respectively.","['perinatal HIV-infected rural South African women', 'HIV-infected women enrolled in a cluster-randomized, controlled trial in South Africa', 'Women (n\u2009=\u20091370) attending 12 community health centers were consecutively enrolled in a two-phase (phase 1\u2009=\u2009without a male partner, phase 2\u2009=\u2009with a male partner) and two']","['condition (experimental or control) prevention of mother-to-child transmission (PMTCT) intervention', 'mother-to-child transmission (PMTCT) intervention']","['perinatal depressive symptoms', 'depression', 'depressive symptoms', '12-point Edinburgh Postnatal Depression Scale (EPDS) cutoff', 'HIV stigma and intimate partner violence', 'Greater HIV stigma, increased psychological intimate partner violence, less male involvement, lower education, and non-adherence']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0282474', 'cui_str': 'Mother-to-Child Transmission'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}]",,0.0648498,"Antenatally, 45.4% of women were above the 12-point Edinburgh Postnatal Depression Scale (EPDS) cutoff, 30.2% were above the cutoff at 6 weeks, and 34.2% and 36.9% at 6 months and 12 months postpartum, respectively.","[{'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Peltzer', 'Affiliation': 'HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa. kpeltzer@hsrc.ac.za.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Abbamonte', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Lissa N', 'Initials': 'LN', 'LastName': 'Mandell', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Violeta J', 'Initials': 'VJ', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Tae Kyoung', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}]",Archives of women's mental health,['10.1007/s00737-019-00955-7']
817,32223113,Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery.,"BACKGROUND


Nonmajor orthopedic surgery of the lower limbs that results in transient reduced mobility places patients at risk for venous thromboembolism. Rivaroxaban may be noninferior to enoxaparin with regard to the prevention of major venous thromboembolism in these patients.
METHODS


In this international, parallel-group, randomized, double-blind, noninferiority trial, we randomly assigned adult patients undergoing lower-limb nonmajor orthopedic surgery who were considered to be at risk for venous thromboembolism on the basis of the investigator's judgment to receive either rivaroxaban or enoxaparin. The primary efficacy outcome of major venous thromboembolism was a composite of symptomatic distal or proximal deep-vein thrombosis, pulmonary embolism, or venous thromboembolism-related death during the treatment period or asymptomatic proximal deep-vein thrombosis at the end of treatment. A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin. For all outcomes, multiple imputation was used to account for missing data. Prespecified safety outcomes included major bleeding (fatal, critical, or clinically overt bleeding or bleeding at the surgical site leading to intervention) and nonmajor clinically relevant bleeding.
RESULTS


A total of 3604 patients underwent randomization; 1809 patients were assigned to receive rivaroxaban, and 1795 to receive enoxaparin. Major venous thromboembolism occurred in 4 of 1661 patients (0.2%) in the rivaroxaban group and in 18 of 1640 patients (1.1%) in the enoxaparin group (risk ratio with multiple imputation, 0.25; 95% confidence interval, 0.09 to 0.75; P<0.001 for noninferiority; P = 0.01 for superiority). The incidence of bleeding did not differ significantly between the rivaroxaban group and the enoxaparin group (1.1% and 1.0%, respectively, for major bleeding or nonmajor clinically relevant bleeding; 0.6% and 0.7%, respectively, for major bleeding).
CONCLUSIONS


Rivaroxaban was more effective than enoxaparin in the prevention of venous thromboembolic events during a period of immobilization after nonmajor orthopedic surgery of the lower limbs. (Funded by Centre Hospitalier Universitaire de Saint-Etienne and Bayer; PRONOMOS ClinicalTrials.gov number, NCT02401594.).",2020,A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin.,"['Nonmajor Orthopedic Surgery', '3604 patients underwent randomization; 1809 patients', ""adult patients undergoing lower-limb nonmajor orthopedic surgery who were considered to be at risk for venous thromboembolism on the basis of the investigator's judgment to receive either""]","['enoxaparin', 'Rivaroxaban', 'Rivaroxaban or Enoxaparin', 'rivaroxaban', 'rivaroxaban or enoxaparin']","['venous thromboembolic events', 'incidence of bleeding', 'major venous thromboembolism was a composite of symptomatic distal or proximal deep-vein thrombosis, pulmonary embolism, or venous thromboembolism-related death during the treatment period or asymptomatic proximal deep-vein thrombosis', 'major bleeding or nonmajor clinically relevant bleeding', 'Major venous thromboembolism', 'major bleeding (fatal, critical, or clinically overt bleeding or bleeding at the surgical site leading to intervention) and nonmajor clinically relevant bleeding']","[{'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",3604.0,0.445584,A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin.,"[{'ForeName': 'C Marc', 'Initials': 'CM', 'LastName': 'Samama', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Silvy', 'Initials': 'S', 'LastName': 'Laporte', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rosencher', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Girard', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Llau', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mouret', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fisher', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez-Martín', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duverger', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Deygas', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Presles', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Cucherat', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mismetti', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1913808']
818,32218125,Solidago virgaurea  L. Plant Extract Targeted Against  Candida albicans  to Reduce Oral Microbial Biomass: a Double Blind Randomized Trial on Healthy Adults.,"Oral microbiome plays an important part on oral health and endogenous bacteria and fungi should not be eradicated. However, their proliferation must be controlled by oral hygiene care. In vitro,  Solidago virgaurea  ssp.  virgaurea  L. (SV) plant extract inhibits the adherence and hyphal formation of a fungus,  Candida albicans . It reduces the biomass of  Candida -bacterial biofilms but not fungal or bacterial growth. Unlike chemical antiseptics, like triclosan and chlorhexidine for instance, SV is a plant extract easily biodegradable. The purpose of this study was to assess the in vivo effectiveness of SV extract in reducing oral biomass. A randomized, double-blind clinical study, with dental plaque evaluation designed to assess the effectiveness of a fluorinated toothpaste containing SV (Bucovia™, Givaudan, Vernier, Switzerland) was conducted. Sixty-six subjects (SV group  n  = 33 vs. control  n  = 33) brushed their teeth twice a day for a 4-week period. Supragingival dental plaque was sampled. Total bacterial load (broad spectral bacterial quantitative Polymerase Chain Reaction (qPCR)),  C. albicans  and seven bacterial species were quantified by qPCR. In the Intervention group, there was a decrease of Total bacterial load (ΔD0D28  p  = 0.005 and ΔD14D28  p  = 0.026),  Streptococcus mutans  (ΔD0D14  p  = 0.024) and  C. albicans  (ΔD0D28  p  = 0.022). In the Control group Total bacterial load tended to decrease from baseline to day 28 (ΔD0D28  p  = 0.062 and ΔD14D28  p  = 0.009). Plaque Index and Gingival Index improved in both groups.",2020,"virgaurea  L. (SV) plant extract inhibits the adherence and hyphal formation of a fungus,  Candida albicans .",['Healthy Adults'],"['chlorhexidine', 'fluorinated toothpaste containing SV (Bucovia™, Givaudan, Vernier, Switzerland', 'virgaurea  L. (SV) plant extract', 'SV extract', 'Solidago virgaurea  L. Plant Extract']","['Total bacterial load', 'Total bacterial load (broad spectral bacterial quantitative Polymerase Chain Reaction (qPCR)),  C. albicans  and seven bacterial species', 'biomass of  Candida -bacterial biofilms', 'oral biomass', 'Plaque Index and Gingival Index']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0032081', 'cui_str': 'Plant Extracts'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1441204', 'cui_str': 'Solidago virgaurea'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0006836', 'cui_str': 'Monilia'}, {'cui': 'C0081786', 'cui_str': 'Biofilms'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}]",66.0,0.0868541,"virgaurea  L. (SV) plant extract inhibits the adherence and hyphal formation of a fungus,  Candida albicans .","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Prêcheur', 'Affiliation': ""Université Nice Côte d'Azur, Faculté de Chirurgie Dentaire, Laboratoire Micoralis EA 7354, 06300 Nice, France.""}, {'ForeName': 'Yohan', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Givaudan, Naturex, 84140 Avignon, France.'}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Hasseine', 'Affiliation': ""Université Nice Côte d'Azur, Centre Hospitalier Universitaire, Laboratoire de Parasitologie-Mycologie, 06200 Nice, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Orange', 'Affiliation': ""Université Nice Côte d'Azur, Faculté des Sciences, Centre Commun de Microscopie Appliquée (CCMA), 06000 Nice, France.""}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Morisot', 'Affiliation': ""Université Nice Côte d'Azur, Centre Hospitalier Universitaire, Département de Santé Publique, 06200 Nice, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Landreau', 'Affiliation': ""Université Nice Côte d'Azur, Centre Hospitalier Universitaire, Laboratoire de Parasitologie-Mycologie, 06200 Nice, France.""}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9040137']
819,32220916,"Combination Therapy With Canagliflozin Plus Liraglutide Exerts Additive Effect on Weight Loss, but Not on HbA 1c , in Patients With Type 2 Diabetes.","OBJECTIVE


To examine the effect of combination therapy with canagliflozin plus liraglutide on HbA 1c , endogenous glucose production (EGP), and body weight versus each therapy alone.
RESEARCH DESIGN AND METHODS


Forty-five patients with poorly controlled (HbA 1c  7-11%) type 2 diabetes mellitus (T2DM) on metformin with or without sulfonylurea received a 9-h measurement of EGP with [3- 3 H]glucose infusion, after which they were randomized to receive  1 ) liraglutide 1.2 mg/day (LIRA),  2 ) canagliflozin 100 mg/day (CANA), or  3 ) liraglutide 1.2 mg plus canagliflozin 100 mg (CANA/LIRA) for 16 weeks. At 16 weeks, the EGP measurement was repeated.
RESULTS


The mean decrease from baseline to 16 weeks in HbA 1c  was -1.67 ± 0.29% ( P  = 0.0001), -0.89 ± 0.24% ( P  = 0.002), and -1.44 ± 0.39% ( P  = 0.004) in patients receiving CANA/LIRA, CANA, and LIRA, respectively. The decrease in body weight was -6.0 ± 0.8 kg ( P  < 0.0001), -3.5 ± 0.5 kg ( P  < 0.0001), and -1.9 ± 0.8 kg ( P  = 0.03), respectively. CANA monotherapy caused a 9% increase in basal rate of EGP ( P  < 0.05), which was accompanied by a 50% increase ( P  < 0.05) in plasma glucagon-to-insulin ratio. LIRA monotherapy reduced plasma glucagon concentration and inhibited EGP. In CANA/LIRA-treated patients, EGP increased by 15% ( P  < 0.05), even though the plasma insulin response was maintained at baseline and the CANA-induced rise in plasma glucagon concentration was blocked.
CONCLUSIONS


These results demonstrate that liraglutide failed to block the increase in EGP caused by canagliflozin despite blocking the rise in plasma glucagon and preventing the decrease in plasma insulin concentration caused by canagliflozin. The failure of liraglutide to prevent the increase in EGP caused by canagliflozin explains the lack of additive effect of these two agents on HbA 1c .",2020,"In CANA/LIRA-treated patients, EGP increased by 15% ( P  < 0.05), even though the plasma insulin response was maintained at baseline and the CANA-induced rise in plasma glucagon concentration was blocked.
","['Patients With Type 2 Diabetes', 'Forty-five patients with poorly controlled (HbA 1c  7-11%) type 2 diabetes mellitus (T2DM) on']","['Canagliflozin Plus Liraglutide', 'liraglutide', 'liraglutide 1.2 mg/day (LIRA);  2 ) canagliflozin 100 mg/day (CANA); or  3 ) liraglutide 1.2 mg plus canagliflozin 100 mg (CANA/LIRA', 'canagliflozin plus liraglutide', 'metformin with or without sulfonylurea received a 9-h measurement of EGP with [3- 3 H]glucose infusion', 'LIRA monotherapy']","['Weight Loss', 'plasma glucagon concentration', 'HbA 1c , endogenous glucose production (EGP), and body weight', 'plasma insulin concentration', 'plasma insulin response', 'plasma glucagon-to-insulin ratio', 'body weight', 'basal rate of EGP', 'EGP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C3556805', 'cui_str': 'canagliflozin 100 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0033268'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]",45.0,0.0331542,"In CANA/LIRA-treated patients, EGP increased by 15% ( P  < 0.05), even though the plasma insulin response was maintained at baseline and the CANA-induced rise in plasma glucagon concentration was blocked.
","[{'ForeName': 'Ali Muhammed', 'Initials': 'AM', 'LastName': 'Ali', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Martinez', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Al-Jobori', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Triplitt', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX albarado@uthscsa.edu.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Cersosimo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}]",Diabetes care,['10.2337/dc18-2460']
820,32219499,Describing the resource utilisation and costs associated withvertebral fractures: the Build Better Bones with Exercise (B3E) Pilot Trial.,"This analysis examined costs/resources of 141 women with vertebral fractures, randomised to a home exercise programme or control group. Total, mean costs and the incremental cost-effectiveness ratio (ICER) were calculated. Quality of life was collected. Cost drivers were caregiver time, medications and adverse events (AEs). Results show adding an exercise programme may reduce the risk of AEs.
INTRODUCTION


This exploratory economic analysis examined the health resource utilisation and costs experienced by women with vertebral fractures, and explored the effects of home exercise on those costs.
METHODS


Women ≥ 65 years with one or more X-ray-confirmed vertebral fractures were randomised 1:1 to a 12-month home exercise programme or equal attention control group. Clinical and health system resources were collected during monthly phone calls and daily diaries completed by participants. Intervention costs were included. Unit costs were applied to health system resources. Quality of life (QoL) information was collected via EQ-5D-5L at baseline, 6 and 12 months.
RESULTS


One hundred and forty-one women were randomised. Overall total costs (CAD 2018) were $664,923 (intervention) and $614,033 (control), respectively. The top three cost drivers were caregiver time ($250,269 and $240,811), medications ($151,000 and $122,145) and AEs ($58,807 and $71,981). The mean cost per intervention participant of $9365 ± $9988 was higher compared with the mean cost per control participant of $8772 ± $9718. The mean EQ-5D index score was higher for the intervention participants (0.81 ± 0.11) compared with that of controls (0.79 ± 0.13). The differences in quality-adjusted life year (QALY) (0.02) and mean cost ($593) were used to calculate the ICER of $29,650.
CONCLUSIONS


Women with osteoporosis with a previous fracture experience a number of resources and associated costs that impact their care and quality of life. Caregiver time, medications and AEs are the biggest cost drivers for this population. The next steps would be to expand this feasibility study with more participants, longer-term follow-up and more regional variability.",2020,The mean EQ-5D index score was higher for the intervention participants (0.81 ± 0.11) compared with that of controls (0.79 ± 0.13).,"['Women ≥', '65\xa0years with one or more X-ray-confirmed vertebral fractures', 'Women with osteoporosis with a previous fracture experience', 'One hundred and forty-one women were randomised', '141 women with vertebral fractures', 'women with vertebral fractures']","['home exercise programme or control group', 'home exercise programme or equal attention control group']","['caregiver time', 'Total, mean costs and the incremental cost-effectiveness ratio (ICER', 'mean EQ-5D index score', 'risk of AEs', 'quality-adjusted life year (QALY) (0.02) and mean cost', 'Quality of life (QoL) information', 'caregiver time, medications and adverse events (AEs', 'Quality of life', 'Caregiver time, medications and AEs', 'Overall total costs\xa0(CAD 2018']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}]","[{'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",141.0,0.0806214,The mean EQ-5D index score was higher for the intervention participants (0.81 ± 0.11) compared with that of controls (0.79 ± 0.13).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hassan', 'Affiliation': 'HOPE Research Centre, Sunnybrook Research Institute, Toronto, Ontario, M4N 3M5, Canada. shazia.hassan@sunnybrook.ca.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Seung', 'Affiliation': 'HOPE Research Centre, Sunnybrook Research Institute, Toronto, Ontario, M4N 3M5, Canada.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Clark', 'Affiliation': 'University of Waterloo, Waterloo, Canada.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Gibbs', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'McMaster University, Hamilton, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mittmann', 'Affiliation': 'Cancer Care Ontario, Toronto, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'McMaster University, Hamilton, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kendler', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Papaioannou', 'Affiliation': 'McMaster University, Hamilton, Canada.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Wark', 'Affiliation': 'University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Ashe', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Adachi', 'Affiliation': 'McMaster University, Hamilton, Canada.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Templeton', 'Affiliation': 'University of Waterloo, Waterloo, Canada.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Giangregorio', 'Affiliation': 'University of Waterloo, Waterloo, Canada.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05387-z']
821,31437865,"Randomised clinical trial: safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of tegoprazan (CJ-12420), a novel potassium-competitive acid blocker, in healthy male subjects.","BACKGROUND


Tegoprazan (CJ-12420) is a potassium-competitive acid blocker (P-CAB) with therapeutic potential for gastro-oesophageal reflux disease (GERD) by reversibly suppressing gastric H +  /K +  -ATPase.
AIMS


To investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of tegoprazan METHODS: A phase I, randomised, double-blind and placebo-controlled clinical trial was conducted in 56 healthy male subjects without Helicobacter pylori infection. In the single ascending dose study, 50, 100, 200 and 400 mg tegoprazan were administered to 32 subjects. In the multiple ascending dose study, 100 and 200 mg tegoprazan were administered every 24 hours to each of the eight subjects for 7 days. In the comparative pharmacodynamics study, 40 mg esomeprazole was administered to eight subjects every 24 hours for 7 days. The assessment included safety, tolerability, pharmacodynamics through monitoring of 24-hour gastric pH and pharmacokinetics of tegoprazan in plasma and urine.
RESULTS


Tegoprazan was generally well tolerated. Most adverse events reported in the study were mild in intensity and resolved without any sequelae. Exposure to tegoprazan increased in a dose-proportional manner. Multiple dosing with tegoprazan showed no accumulation in plasma on day 7. The pharmacodynamic analysis revealed that tegoprazan showed rapid, dose-dependent gastric acid suppression.
CONCLUSIONS


Tegoprazan was well tolerated and showed rapid and potent gastric acid suppression. This supports the further development of tegoprazan as a treatment for acid-related disorders.",2019,Multiple dosing with tegoprazan showed no accumulation in plasma on day 7.,"['healthy male subjects', '56 healthy male subjects without Helicobacter pylori infection']","['Tegoprazan', 'placebo', 'potassium-competitive acid blocker', 'tegoprazan (CJ-12420', 'esomeprazole', 'tegoprazan']","['tolerated', 'safety, tolerability, pharmacokinetics and pharmacodynamics', 'tolerated and showed rapid and potent gastric acid suppression', 'safety, tolerability, pharmacodynamics through monitoring of 24-hour gastric pH and pharmacokinetics of tegoprazan in plasma and urine']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0017119', 'cui_str': 'Hydrochloric Acid, Gastric'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1168023', 'cui_str': 'Gastric pH'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0042037'}]",56.0,0.0985526,Multiple dosing with tegoprazan showed no accumulation in plasma on day 7.,"[{'ForeName': 'Sungpil', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': ""Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary's Hospital, PIPET (Pharmacometrics Institute for Practical Education and Training), College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Hee Youn', 'Initials': 'HY', 'LastName': 'Choi', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Yo Han', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Nam', 'Affiliation': 'CJ HealthCare Corporation, Seoul, Korea.'}, {'ForeName': 'Bongtae', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'CJ HealthCare Corporation, Seoul, Korea.'}, {'ForeName': 'Geun Seog', 'Initials': 'GS', 'LastName': 'Song', 'Affiliation': 'CJ HealthCare Corporation, Seoul, Korea.'}, {'ForeName': 'Hyeong-Seok', 'Initials': 'HS', 'LastName': 'Lim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Kyun-Seop', 'Initials': 'KS', 'LastName': 'Bae', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15438']
822,31714506,Effects of Expressing Writing on organizational variables in Palliative Care health Professionals: an explorative study.,"BACKGROUND AND AIM


Healthcare professionals working in palliative care are exposed to emotionally intense conditions. Scientific literature suggests Expressive Writing as a valid tool for the adjustment to traumatic events. For health workers, EW represents an important support to prevent Compassion Fatigue and Burnout. As literature showed that Compassion Satisfaction, Group Cohesion and the Organizational Commitment are protective factors able to counter the onset of Compassion Fatigue and Burnout, the aim of this study is evaluating the effect of Expressive Writing protocol in Palliative Care workers on Compassion Satisfaction, Group Cohesion and Organizational Commitment.
METHODS


A quasi-experimental quantitative 2x2 prospective study was conducted with two groups and two measurements. 66 professionals were included. Outcome variables were measured using: Organizational Commitment Questionnaire, Compassion Satisfaction Rating Scale, ICONAS Questionnaire, Questionnaire for the evaluation of EW sessions.
RESULTS


The parametric analysis through Student t test did not show statistical significance within the experimental group and between the experimental and control groups. One significant difference in the pre-intervention assessment of Normative Commitment t (gl 64) = -2.008 for p< 0.05, higher in the control group, disappeared in the post intervention evaluation. An improvement trend in all variables within and between groups was present, with a positive assessment of utility from the participants.
CONCLUSIONS


This intervention did not significantly impact outcome variables. It is however conceivable that by modifying the intervention methodology, it could prove effective. The positive evaluation by the operators, suggests to keep trying modelling a protocol tailored on Palliative Care professionals.",2019,The parametric analysis through Student t test did not show statistical significance within the experimental group and between the experimental and control groups.,"['66 professionals were included', 'Palliative Care health Professionals']","['Expressive Writing protocol', 'Expressing Writing']","['Organizational Commitment Questionnaire, Compassion Satisfaction Rating Scale, ICONAS Questionnaire, Questionnaire for the evaluation of EW sessions']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",66.0,0.0595422,The parametric analysis through Student t test did not show statistical significance within the experimental group and between the experimental and control groups.,"[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cosentino', 'Affiliation': 'University of Parma. chiara.cosentino1@unipr.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Corte', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Fioresi', 'Affiliation': ''}, {'ForeName': 'Fiorella', 'Initials': 'F', 'LastName': 'Molina Ojeda', 'Affiliation': ''}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pastore', 'Affiliation': ''}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Severgnini', 'Affiliation': ''}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Spacci', 'Affiliation': ''}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Artioli', 'Affiliation': ''}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v90i11-S.8946']
823,32215653,"Histological Evaluation of the Skin After Fat Grafting: A Blinded, Randomized, Controlled Clinical Study.","BACKGROUND


Autologous fat graft is often employed to treat body contour defects. There is currently increased interest in the regenerative properties of fat grafting.
OBJECTIVES


The authors evaluated the histological changes of fat grafting in a blinded randomized controlled trial of staged fat grafting-abdominoplasty.
METHODS


Ten women between 24 and 55 years of age with a body mass index <30 kg/m2 and previous cesarean scar were submitted to fat grafting followed by staged abdominoplasty. The C-section scar served as a landmark for standardization of fat grafting site and control. One side of the abdomen was fat grafted and the other was left intact (control). At the time of abdominoplasty, 4 months later, a full-thickness skin sample from each hemi abdomen (fat-grafted area and control) was collected and sent to histological analysis.
RESULTS


All of the fat-grafted samples showed extracellular lipids and signs of fat graft viability, whereas no such changes occurred in the control group. There were no statistically significant differences in fat-grafted vs control samples regarding skin inflammatory infiltrate (P = 0.582), dermis thickness (P = 0.973), vascular density (P = 0.326), and amount of elastic fibers (P = 1).
CONCLUSIONS


The histological evaluation of women's abdominoplasty surgical site skin after 4 months of fat grafting showed signs of fat graft in 100% of the grafted sides but no change in skin inflammatory infiltrate, dermis thickness, vascularity density, or elastic fiber quantity.",2020,"There were no statistically significant differences in fat-grafted vs control samples regarding skin inflammatory infiltrate (P = 0.582), dermis thickness (P = 0.973), vascular density (P = 0.326), and amount of elastic fibers (P = 1).
",['Ten women between 24 and 55 years of age with a body mass index <30 kg/m2 and previous cesarean scar'],"['Skin', 'fat grafting followed by staged abdominoplasty', 'staged fat grafting-abdominoplasty']","['vascular density', 'extracellular lipids and signs of fat graft viability', 'dermis thickness', 'skin inflammatory infiltrate', 'signs of fat graft', 'amount of elastic fibers', 'skin inflammatory infiltrate, dermis thickness, vascularity density, or elastic fiber quantity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0011646', 'cui_str': 'Corium'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0230899', 'cui_str': 'Elastic Fibers'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]",10.0,0.0776158,"There were no statistically significant differences in fat-grafted vs control samples regarding skin inflammatory infiltrate (P = 0.582), dermis thickness (P = 0.973), vascular density (P = 0.326), and amount of elastic fibers (P = 1).
","[{'ForeName': 'Juan P B R', 'Initials': 'JPBR', 'LastName': 'Maricevich', 'Affiliation': 'Department of Plastic Surgery, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Marcel F M B', 'Initials': 'MFMB', 'LastName': 'Lima', 'Affiliation': 'Department of Plastic Surgery, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Maricevich', 'Affiliation': ''}, {'ForeName': 'Marco A B R', 'Initials': 'MABR', 'LastName': 'Maricevich', 'Affiliation': 'Division of Plastic Surgery, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Larissa F J', 'Initials': 'LFJ', 'LastName': 'Silva', 'Affiliation': 'Department of Pathology, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Daniela M', 'Initials': 'DM', 'LastName': 'Takano', 'Affiliation': 'Department of Pathology, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Anlicoara', 'Affiliation': 'Department of Plastic Surgery, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}]",Aesthetic surgery journal,['10.1093/asj/sjz327']
824,32217783,Energy conservation technique improves dyspnoea when patients with severe COPD climb stairs: a randomised crossover study.,"In this randomised, crossover trial, 22 patients with severe chronic obstructive pulmonary disease climbed six flights of stairs (108 steps) twice, under two test conditions: (1) energy conservation technique (ECT): participants were asked to rest for at least 5 seconds every three steps and (2) control condition: participants climbed the stairs at their own pace. Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition were found, with no change in total task time. CLINICAL TRIAL REGISTRATION: NCT03564028.",2020,"Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition were found, with no change in total task time.","['patients with severe COPD climb stairs', '22 patients with severe chronic obstructive pulmonary disease climbed six flights of stairs (108 steps) twice, under two test conditions: (1']","['Energy conservation technique', 'energy conservation technique (ECT']","['dyspnoea', 'Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition', 'total task time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease (disorder)'}, {'cui': 'C0561942', 'cui_str': 'Does climb (finding)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0449910', 'cui_str': 'Test conditions (attribute)'}]","[{'cui': 'C1621943', 'cui_str': 'Energy conservation'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0859235', 'cui_str': 'Lower extremities ill feeling of'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",22.0,0.0844287,"Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition were found, with no change in total task time.","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Prieur', 'Affiliation': 'Institute of Experimental and Clinical Research (IREC), Pole of Pulmonology, ORL and Dermatology, Université catholique de Louvain, 1200, Belgium gprieur.kine@gmail.com.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Combret', 'Affiliation': 'Institute of Experimental and Clinical Research (IREC), Pole of Pulmonology, ORL and Dermatology, Université catholique de Louvain, 1200, Belgium.'}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Medrinal', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Arnol', 'Affiliation': 'ICADOM, AGIR à dom, Meylan, France.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Bonnevie', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Francis-Edouard', 'Initials': 'FE', 'LastName': 'Gravier', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Quieffin', 'Affiliation': 'Pulmonology department and pulmonary rehabilitation department, Groupe Hospitalier du Havre, 76290 Montivilliers, France.'}, {'ForeName': 'Bouchra', 'Initials': 'B', 'LastName': 'Lamia', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Institute of Experimental and Clinical Research (IREC), Pole of Pulmonology, ORL and Dermatology, Université catholique de Louvain, 1200, Belgium.'}, {'ForeName': 'Jean-Christian', 'Initials': 'JC', 'LastName': 'Borel', 'Affiliation': 'R&D, AGIR à dom, Meylan, France.'}]",Thorax,['10.1136/thoraxjnl-2019-214295']
825,31124194,"The effects of GSK2981710, a medium-chain triglyceride, on cognitive function in healthy older participants: A randomised, placebo-controlled study.","OBJECTIVE


This double-blind, randomised, placebo-controlled, two-part study assessed the impact of GSK2981710, a medium-chain triglyceride (MCT) that liberates ketone bodies, on cognitive function, safety, and tolerability in healthy older adults.
METHODS


Part 1 was a four-period dose-selection study (n = 8 complete). Part 2 was a two-period crossover study (n = 80 complete) assessing the acute (Day 1) and prolonged (Day 15) effects of GSK2981710 on cognition and memory-related neuronal activity. Safety and tolerability of MCT supplementation were monitored in both parts of the study.
RESULTS


The most common adverse event was diarrhoea (100% and 75% of participants in Parts 1 and 2, respectively). Most adverse events were mild to moderate, and 11% participants were withdrawn due to one or more adverse events. Although GSK2981710 (30 g/day) resulted in increased peak plasma β-hydroxybutyrate (BHB) concentrations, no significant improvements in cognitive function or memory-related neuronal activity were observed.
CONCLUSION


Over a duration of 14 days, increasing plasma BHB levels with daily administration of GSK2981710 had no effects on neuronal activity or cognitive function. This result indicates that modulating plasma ketone levels with GSK2981710 may be ineffective in improving cognitive function in healthy older adults, or the lack of observed effect could be related to several factors including study population, plasma BHB concentrations, MCT composition, or treatment duration.",2019,"The most common adverse event was diarrhoea (100% and 75% of participants in Parts 1 and 2, respectively).","['healthy older adults', 'Part 1 was a four-period dose-selection study (n\xa0=\xa08 complete', 'healthy older participants']","['MCT', 'GSK2981710, a medium-chain triglyceride', 'placebo', 'GSK2981710, a medium-chain triglyceride (MCT']","['peak plasma β-hydroxybutyrate (BHB) concentrations', 'plasma BHB levels', 'diarrhoea', 'cognitive function, safety, and tolerability', 'cognitive function or memory-related neuronal activity', 'cognition and memory-related neuronal activity', 'Safety and tolerability', 'neuronal activity or cognitive function']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.19717,"The most common adverse event was diarrhoea (100% and 75% of participants in Parts 1 and 2, respectively).","[{'ForeName': 'Barry V', 'Initials': 'BV', 'LastName': ""O'Neill"", 'Affiliation': 'GSK Nutrition, GSK Consumer Healthcare, Brentford, UK.'}, {'ForeName': 'Chris M', 'Initials': 'CM', 'LastName': 'Dodds', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sam R', 'Initials': 'SR', 'LastName': 'Miller', 'Affiliation': 'Department of Quantitative Sciences, GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Quantitative Sciences India, GlaxoSmithKline, Bangalore, India.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Lawrence', 'Affiliation': 'Clinical Unit, GlaxoSmithKline, Cambridge, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bullman', 'Affiliation': 'Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, London, UK.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Dewit', 'Affiliation': 'Clinical Unit, GlaxoSmithKline, Cambridge, UK.'}, {'ForeName': 'Subramanya', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Clinical Unit, GlaxoSmithKline, Cambridge, UK.'}, {'ForeName': 'Mushi', 'Initials': 'M', 'LastName': 'Dustagheer', 'Affiliation': 'Clinical Unit, GlaxoSmithKline, Cambridge, UK.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Price', 'Affiliation': 'Clinical Unit, GlaxoSmithKline, Cambridge, UK.'}, {'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Shabbir', 'Affiliation': 'Clinical Pharmacology Study Sciences and Operations, GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Pradeep J', 'Initials': 'PJ', 'LastName': 'Nathan', 'Affiliation': 'Sosei Heptares, Cambridge, UK.'}]",Human psychopharmacology,['10.1002/hup.2694']
826,32223340,The Effects of a Citywide Bike Share System on Active Transportation Among College Students: A Randomized Controlled Pilot Study.,"Introduction.  Despite the known health benefits of biking, within the last year, 46% of college students reported not riding a bike. This trend indicates a need to explore interventions to increase bicycling. The purpose of this study was to examine how a free membership to a citywide bike share system, with a campus docking station, affected bicycling and physical activity.  Method.  Undergraduate students were recruited from a Midwest University to participate in this research study in spring 2018. Each participant wore an activity-tracking device for 3 weeks and was randomly assigned to either an intervention group ( n  = 29) or a control group ( n  = 27). Participants in the intervention group received a free 1-month membership to Kansas City's bike share system, B-cycle. Data on the type of activity (e.g., biking), the frequency, duration, and overall steps were collected. A pre- and posttest survey was developed and distributed to assess perceptions and use of bicycles and the bike share system.  T  tests were performed to identify differences between the two groups.  Results.  Data analyses reveal no significant differences in overall steps or increased biking behavior between the two groups. Furthermore, only two of participants who received a free bike share membership redeemed their membership. Among other barriers, risk of overage fees or not wanting to enter credit/debit card information emerged as major themes that deterred participants.  Conclusions.  Results from this study will inform future interventions to decrease barriers, increase physical activity, and increase the proportions of trips taken by bike among college students. More specifically, alternative payment methods should be explored to decrease the barriers observed.",2020,Data analyses reveal no significant differences in overall steps or increased biking behavior between the two groups.,"['College Students', 'Undergraduate students were recruited from a Midwest University to participate in this research study in spring 2018']","[""free 1-month membership to Kansas City's bike share system, B-cycle"", 'Citywide Bike Share System on Active Transportation']","['biking behavior', 'type of activity (e.g., biking), the frequency, duration, and overall steps', 'physical activity']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0035168'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0459205', 'cui_str': 'Type of activity (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0295729,Data analyses reveal no significant differences in overall steps or increased biking behavior between the two groups.,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Grimes', 'Affiliation': 'University of Missouri-Kansas City, MO, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Baker', 'Affiliation': 'University of Missouri-Kansas City, MO, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198120914244']
827,31181957,Cluster Randomized Trial Examining the Impact of Automated Best Practice Alert on Rates of Implantable Defibrillator Therapy.,"Background Implantable cardioverter-defibrillators (ICDs) are indicated in patients with left ventricular ejection fraction ≤35%, but many eligible patients do not receive this therapy. In this cluster randomized trial, we investigated the impact of a best practice alert (BPA) through the electronic health records on the rates of electrophysiology referrals, ICD implantations, and all-cause mortality in severe cardiomyopathy patients. Methods and Results Providers in the Heart and Vascular Institute (n=106) and in General Internal Medicine (n=89) were randomized to receive or not receive a BPA recommending consideration for ICD implantation. Patients belonging to the BPA and no BPA groups of providers were followed to the end points of electrophysiology referrals, ICD implantations, and all-cause mortality. Between 2013 and 2015, patients with reduced left ventricular ejection fraction were managed by 93 providers in the BPA (n=997 patients) and 102 providers in the no BPA (n=909 patients) groups. Patients in the 2 groups had comparable baseline characteristics. After a median follow-up of 36 months, 638 (33%) patients were referred to electrophysiology, 536 (27%) received an ICD, and 445 (23%) died. Patients in the BPA group were more likely to be referred to electrophysiology (hazard ratio=1.23; P=0.026), to receive ICD therapy (hazard ratio=1.35; P=0.006), and exhibited a trend towards slightly lower mortality (hazard ratio=0.85; P=0.091). Conclusions Delivering a BPA through the electronic health record recommending to providers consideration of ICD implantation when the left ventricular ejection fraction is ≤35% improves the rates of electrophysiology referrals and ICD therapy in patients with severe left ventricular dysfunction.",2019,"Patients in the BPA group were more likely to be referred to electrophysiology (hazard ratio=1.23; P=0.026), to receive ICD therapy (hazard ratio=1.35; P=0.006), and exhibited a trend towards slightly lower mortality (hazard ratio=0.85; P=0.091).","['Between 2013 and 2015, patients with reduced left ventricular ejection fraction were managed by 93 providers in the BPA (n=997 patients) and 102 providers in the no BPA (n=909 patients) groups', 'patients with severe left ventricular dysfunction', 'Heart and Vascular Institute (n=106) and in General Internal Medicine (n=89', 'severe cardiomyopathy patients', 'patients with left ventricular ejection fraction ≤35']","['BPA recommending consideration for ICD implantation', ' Implantable cardioverter-defibrillators (ICDs']",['mortality'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0242973', 'cui_str': 'Ventricular Dysfunction'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0931906,"Patients in the BPA group were more likely to be referred to electrophysiology (hazard ratio=1.23; P=0.026), to receive ICD therapy (hazard ratio=1.35; P=0.006), and exhibited a trend towards slightly lower mortality (hazard ratio=0.85; P=0.091).","[{'ForeName': 'Jae', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Heart and Vascular Institute, Division of Cardiology, Department of Medicine (J.S.L., M.S., F.T., A.D.A., J.L., S.S.).'}, {'ForeName': 'Libby', 'Initials': 'L', 'LastName': 'Szeto', 'Affiliation': 'University of Pittsburgh School of Medicine (L.S.).'}, {'ForeName': 'Deepak Kumar', 'Initials': 'DK', 'LastName': 'Pasupula', 'Affiliation': 'General Internal Medicine, Department of Medicine, (D.K.P, A.H., A.W., S.A., G.F.).'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Hussain', 'Affiliation': 'General Internal Medicine, Department of Medicine, (D.K.P, A.H., A.W., S.A., G.F.).'}, {'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Waheed', 'Affiliation': 'General Internal Medicine, Department of Medicine, (D.K.P, A.H., A.W., S.A., G.F.).'}, {'ForeName': 'Shubash', 'Initials': 'S', 'LastName': 'Adhikari', 'Affiliation': 'General Internal Medicine, Department of Medicine, (D.K.P, A.H., A.W., S.A., G.F.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sharbaugh', 'Affiliation': 'Heart and Vascular Institute, Division of Cardiology, Department of Medicine (J.S.L., M.S., F.T., A.D.A., J.L., S.S.).'}, {'ForeName': 'Floyd', 'Initials': 'F', 'LastName': 'Thoma', 'Affiliation': 'Heart and Vascular Institute, Division of Cardiology, Department of Medicine (J.S.L., M.S., F.T., A.D.A., J.L., S.S.).'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Althouse', 'Affiliation': 'Heart and Vascular Institute, Division of Cardiology, Department of Medicine (J.S.L., M.S., F.T., A.D.A., J.L., S.S.).'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Fischer', 'Affiliation': 'General Internal Medicine, Department of Medicine, (D.K.P, A.H., A.W., S.A., G.F.).'}, {'ForeName': 'Joon Sup', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Heart and Vascular Institute, Division of Cardiology, Department of Medicine (J.S.L., M.S., F.T., A.D.A., J.L., S.S.).'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Saba', 'Affiliation': 'Heart and Vascular Institute, Division of Cardiology, Department of Medicine (J.S.L., M.S., F.T., A.D.A., J.L., S.S.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.118.005024']
828,32022261,"A randomized, phase 1, placebo-controlled trial of APG-157 in oral cancer demonstrates systemic absorption and an inhibitory effect on cytokines and tumor-associated microbes.","BACKGROUND


Although curcumin's effect on head and neck cancer has been studied in vitro and in vivo, to the authors' knowledge its efficacy is limited by poor systemic absorption from oral administration. APG-157 is a botanical drug containing multiple polyphenols, including curcumin, developed under the US Food and Drug Administration's Botanical Drug Development, that delivers the active components to oromucosal tissues near the tumor target.
METHODS


A double-blind, randomized, placebo-controlled, phase 1 clinical trial was conducted with APG-157 in 13 normal subjects and 12 patients with oral cancer. Two doses, 100 mg or 200 mg, were delivered transorally every hour for 3 hours. Blood and saliva were collected before and 1 hour, 2 hours, 3 hours, and 24 hours after treatment. Electrocardiograms and blood tests did not demonstrate any toxicity.
RESULTS


Treatment with APG-157 resulted in circulating concentrations of curcumin and analogs peaking at 3 hours with reduced IL-1β, IL-6, and IL-8 concentrations in the salivary supernatant fluid of patients with cancer. Salivary microbial flora analysis showed a reduction in Bacteroidetes species in cancer subjects. RNA and immunofluorescence analyses of tumor tissues of a subject demonstrated increased expression of genes associated with differentiation and T-cell recruitment to the tumor microenvironment.
CONCLUSIONS


The results of the current study suggested that APG-157 could serve as a therapeutic drug in combination with immunotherapy.
LAY SUMMARY


Curcumin has been shown to suppress tumor cells because of its antioxidant and anti-inflammatory properties. However, its effectiveness has been limited by poor absorption when delivered orally. Subjects with oral cancer were given oral APG-157, a botanical drug containing multiple polyphenols, including curcumin. Curcumin was found in the blood and in tumor tissues. Inflammatory markers and Bacteroides species were found to be decreased in the saliva, and immune T cells were increased in the tumor tissue. APG-157 is absorbed well, reduces inflammation, and attracts T cells to the tumor, suggesting its potential use in combination with immunotherapy drugs.",2020,"Inflammatory markers and Bacteroides species were found to be decreased in the saliva, and immune T cells were increased in the tumor tissue.","['head and neck cancer', 'Subjects with oral cancer', '13 normal subjects and 12 patients with oral cancer', 'cancer subjects']","['APG-157', 'placebo', 'oral APG-157, a botanical drug containing multiple polyphenols, including curcumin', 'placebo-controlled']","['circulating concentrations of curcumin and analogs peaking at 3\xa0hours with reduced IL-1β, IL-6, and IL-8 concentrations', 'Blood and saliva', 'Electrocardiograms and blood tests', 'toxicity', 'Inflammatory markers and Bacteroides species', 'saliva, and immune T cells']","[{'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0153381', 'cui_str': 'Cancer of Mouth'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0005768'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}]",13.0,0.135396,"Inflammatory markers and Bacteroides species were found to be decreased in the saliva, and immune T cells were increased in the tumor tissue.","[{'ForeName': 'Saroj K', 'Initials': 'SK', 'LastName': 'Basak', 'Affiliation': 'Department of Surgery, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Alakesh', 'Initials': 'A', 'LastName': 'Bera', 'Affiliation': 'Department of Anatomy, Physiology and Genetics, Uniformed Services University of Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Yoon', 'Affiliation': 'Pasarow Mass Spectrometry Laboratory, Jane and Terry Semel Institute for Neuroscience and Human Behavior, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Morselli', 'Affiliation': 'Department of Molecular, Cell and Developmental Biology, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Jeong', 'Affiliation': 'Department of Surgery, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Anela', 'Initials': 'A', 'LastName': 'Tosevska', 'Affiliation': 'Department of Molecular, Cell and Developmental Biology, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Tien S', 'Initials': 'TS', 'LastName': 'Dong', 'Affiliation': 'Division of Gastroenterology, Hepatology and Parenteral Nutrition, Department of Medicine, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eklund', 'Affiliation': 'Department of Anatomy, Physiology and Genetics, Uniformed Services University of Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Russ', 'Affiliation': 'Department of Anatomy, Physiology and Genetics, Uniformed Services University of Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Nasser', 'Affiliation': 'Department of Head and Neck Surgery, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Lagishetty', 'Affiliation': 'Division of Gastroenterology, Hepatology and Parenteral Nutrition, Department of Medicine, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Medicine Statistics Core, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Dipti', 'Initials': 'D', 'LastName': 'Sajed', 'Affiliation': 'Department of Pathology, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Mudgal', 'Affiliation': 'Aveta Biomics Inc, Bedford, Massachusetts.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Mehta', 'Affiliation': 'Aveta Biomics Inc, Bedford, Massachusetts.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Avila', 'Affiliation': 'Aveta Biomics Inc, Bedford, Massachusetts.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Srivastava', 'Affiliation': 'Department of Anatomy, Physiology and Genetics, Uniformed Services University of Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Kym', 'Initials': 'K', 'LastName': 'Faull', 'Affiliation': 'Pasarow Mass Spectrometry Laboratory, Jane and Terry Semel Institute for Neuroscience and Human Behavior, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Jacobs', 'Affiliation': 'Division of Gastroenterology, Hepatology and Parenteral Nutrition, Department of Medicine, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Molecular, Cell and Developmental Biology, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Daniel Sanghoon', 'Initials': 'DS', 'LastName': 'Shin', 'Affiliation': 'Jonsson Comprehensive Cancer Center, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Eri S', 'Initials': 'ES', 'LastName': 'Srivatsan', 'Affiliation': 'Department of Surgery, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}, {'ForeName': 'Marilene B', 'Initials': 'MB', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, Veterans Administration Greater Los Angeles Healthcare System, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California.'}]",Cancer,['10.1002/cncr.32644']
829,32220917,"Effects of Low-Energy Diet or Exercise on Cardiovascular Function in Working-Age Adults With Type 2 Diabetes: A Prospective, Randomized, Open-Label, Blinded End Point Trial.","OBJECTIVE


To confirm the presence of subclinical cardiovascular dysfunction in working-age adults with type 2 diabetes (T2D) and determine whether this is improved by a low-energy meal replacement diet (MRP) or exercise training.
RESEARCH DESIGN AND METHODS


This article reports on a prospective, randomized, open-label, blinded end point trial with nested case-control study. Asymptomatic younger adults with T2D were randomized 1:1:1 to a 12-week intervention of  1 ) routine care,  2 ) supervised aerobic exercise training, or  3 ) a low-energy (∼810 kcal/day) MRP. Participants underwent echocardiography, cardiopulmonary exercise testing, and cardiac magnetic resonance (CMR) at baseline and 12 weeks. The primary outcome was change in left ventricular (LV) peak early diastolic strain rate (PEDSR) as measured by CMR. Healthy volunteers were enrolled for baseline case-control comparison.
RESULTS


Eighty-seven participants with T2D (age 51 ± 7 years, HbA 1c  7.3 ± 1.1%) and 36 matched control participants were included. At baseline, those with T2D had evidence of diastolic dysfunction (PEDSR 1.01 ± 0.19 vs. 1.10 ± 0.16 s -1 ,  P  = 0.02) compared with control participants. Seventy-six participants with T2D completed the trial (30 routine care, 22 exercise, and 24 MRP). The MRP arm lost 13 kg in weight and had improved blood pressure, glycemia, LV mass/volume, and aortic stiffness. The exercise arm had negligible weight loss but increased exercise capacity. PEDSR increased in the exercise arm versus routine care (β = 0.132,  P  = 0.002) but did not improve with the MRP (β = 0.016,  P  = 0.731).
CONCLUSIONS


In asymptomatic working-age adults with T2D, exercise training improved diastolic function. Despite beneficial effects of weight loss on glycemic control, concentric LV remodeling, and aortic stiffness, a low-energy MRP did not improve diastolic function.",2020,"PEDSR increased in the exercise arm versus routine care (β = 0.132,  P  = 0.002) but did not improve with the MRP (β = 0.016,  P  = 0.731).
","['asymptomatic working-age adults with T2D', 'Asymptomatic younger adults with T2D', '2 Diabetes', 'Working-Age Adults With Type', 'Healthy volunteers were enrolled for baseline case-control comparison', 'Eighty-seven participants with T2D (age 51 ± 7 years, HbA 1c  7.3 ± 1.1%) and 36 matched control participants were included', 'working-age adults with type 2 diabetes (T2D', 'Seventy-six participants with T2D completed the trial (30 routine care, 22 exercise, and 24 MRP']","['12-week intervention of  1 ) routine care,  2 ) supervised aerobic exercise training, or  3 ) a low-energy (∼810 kcal/day) MRP', 'low-energy meal replacement diet (MRP) or exercise training', 'Low-Energy Diet or Exercise', 'exercise training', 'echocardiography, cardiopulmonary exercise testing, and cardiac magnetic resonance (CMR']","['diastolic dysfunction', 'Cardiovascular Function', 'PEDSR', 'change in left ventricular (LV) peak early diastolic strain rate (PEDSR', 'diastolic function', 'glycemic control, concentric LV remodeling, and aortic stiffness', 'negligible weight loss', 'blood pressure, glycemia, LV mass/volume, and aortic stiffness']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1701620', 'cui_str': 'mercaptopropionyl-phenylalanyl-cyclohexylalanyl-cyclohexylalanyl-arginyl-lysyl-prolyl-asparaginyl-aspartyl-lysinamide'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C1701620', 'cui_str': 'mercaptopropionyl-phenylalanyl-cyclohexylalanyl-cyclohexylalanyl-arginyl-lysyl-prolyl-asparaginyl-aspartyl-lysinamide'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C3654008', 'cui_str': 'Low-energy diets'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}]","[{'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction (finding)'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0332269', 'cui_str': 'Negligible (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",87.0,0.0736891,"PEDSR increased in the exercise arm versus routine care (β = 0.132,  P  = 0.002) but did not improve with the MRP (β = 0.016,  P  = 0.731).
","[{'ForeName': 'Gaurav S', 'Initials': 'GS', 'LastName': 'Gulsin', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Swarbrick', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Athithan', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Emer M', 'Initials': 'EM', 'LastName': 'Brady', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Henson', 'Affiliation': 'Diabetes Research Centre, University of Leicester and the NIHR Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Baldry', 'Affiliation': 'Diabetes Research Centre, University of Leicester and the NIHR Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Argyridou', 'Affiliation': 'Diabetes Research Centre, University of Leicester and the NIHR Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Nishal B', 'Initials': 'NB', 'LastName': 'Jaicim', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Squire', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Walters', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Anna-Marie', 'Initials': 'AM', 'LastName': 'Marsh', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McAdam', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Kelly S', 'Initials': 'KS', 'LastName': 'Parke', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Biglands', 'Affiliation': 'NIHR Leeds Biomedical Research Centre, Leeds, U.K.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester and the NIHR Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester and the NIHR Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester and the NIHR Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K. gpm12@leicester.ac.uk.'}]",Diabetes care,['10.2337/dc20-0129']
830,30995174,Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer.,"PURPOSE


The primary objective was to determine if vaginal cuff brachytherapy and chemotherapy (VCB/C) increases recurrence-free survival (RFS) compared with pelvic radiation therapy (RT) in high-intermediate and high-risk early-stage endometrial carcinoma.
PATIENTS AND METHODS


A randomized phase III trial was performed in eligible patients with endometrial cancer. Eligible patients had International Federation of Gynecology and Obstetrics (2009) stage I endometrioid histology with Gynecologic Oncology Group protocol 33-based high-intermediate-risk criteria, stage II disease, or stage I to II serous or clear cell tumors. Treatment was randomly assigned between RT (45 to 50.4 Gy over 5 weeks) or VCB followed by intravenous paclitaxel 175 mg/m 2  (3 hours) plus carboplatin (area under the curve, 6) every 21 days for three cycles.
RESULTS


The median age of the 601 patients was 63 years, and 74% had stage I disease. Histologies included endometrioid (71%), serous (15%), and clear cell (5%). With a median follow-up of 53 months, the 60-month RFS was 0.76 (95% CI, 0.70 to 0.81) for RT and 0.76 (95% CI, 0.70 to 0.81) for VCB/C (hazard ratio, 0.92; 90% confidence limit, 0.69 to 1.23). The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52). Vaginal and distant recurrence rates were similar between arms. Pelvic or para-aortic nodal recurrences were more common with VCB/C (9%  v  4%). There was no heterogeneity of treatment effect with respect to RFS or overall survival among clinical or pathologic variables evaluated.
CONCLUSION


Superiority of VCB/C compared with pelvic RT was not demonstrated. Acute toxicity was greater with VCB/C; late toxicity was similar. Pelvic RT alone remains an effective, well-tolerated, and appropriate adjuvant treatment in high-risk early-stage endometrial carcinomas of all histologies.",2019,"The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52).","['High-Intermediate and High-Risk Early Stage Endometrial Cancer', 'The median age of the 601 patients was 63 years, and 74% had stage I disease', 'high-intermediate and high-risk early-stage endometrial carcinoma', 'eligible patients with endometrial cancer', 'Eligible patients had International Federation of Gynecology and Obstetrics (2009) stage']","['Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin', 'vaginal cuff brachytherapy and chemotherapy (VCB/C', 'pelvic radiation therapy (RT', 'Pelvic RT alone', 'VCB followed by intravenous paclitaxel 175 mg/m 2  (3 hours) plus carboplatin']","['recurrence-free survival (RFS', 'Pelvic or para-aortic nodal recurrences', 'RFS or overall survival', '60-month overall survival', '60-month RFS', 'Vaginal and distant recurrence rates', 'Acute toxicity']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0854674', 'cui_str': 'Brachytherapy to vagina'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1550321', 'cui_str': 'Vaginal cuff'}, {'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0442134', 'cui_str': 'Peri-aortic'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.213594,"The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52).","[{'ForeName': 'Marcus E', 'Initials': 'ME', 'LastName': 'Randall', 'Affiliation': '1 University of Kentucky, Lexington, KY.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Filiaci', 'Affiliation': '2 NRG Oncology Statistical and Data Center, Buffalo, NY.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'McMeekin', 'Affiliation': '3 University of Oklahoma School of Medicine, Oklahoma City, OK.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'von Gruenigen', 'Affiliation': '4 Summa Health System, Akron, OH.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': '2 NRG Oncology Statistical and Data Center, Buffalo, NY.'}, {'ForeName': 'Catheryn M', 'Initials': 'CM', 'LastName': 'Yashar', 'Affiliation': '5 University of California San Diego, San Diego, CA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': '3 University of Oklahoma School of Medicine, Oklahoma City, OK.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': '6 Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Salani', 'Affiliation': '7 Ohio State University, Columbus, OH.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'DiSilvestro', 'Affiliation': '8 Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Burke', 'Affiliation': '9 Mercer University, Savannah, GA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rutherford', 'Affiliation': '10 Yale University, New Haven, CT.'}, {'ForeName': 'Nick M', 'Initials': 'NM', 'LastName': 'Spirtos', 'Affiliation': ""11 Women's Cancer Center of Nevada, Las Vegas, NV.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Terada', 'Affiliation': '12 University of Hawaii, Honolulu, HI.'}, {'ForeName': 'Penny R', 'Initials': 'PR', 'LastName': 'Anderson', 'Affiliation': '13 Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Wendy R', 'Initials': 'WR', 'LastName': 'Brewster', 'Affiliation': '14 University of North Carolina Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Small', 'Affiliation': '15 Loyola University, Chicago, IL.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Aghajanian', 'Affiliation': '16 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Miller', 'Affiliation': '17 University of Texas Southwestern Medical Center, Dallas, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01575']
831,26776270,"Acceptability of locally produced ready-to-use therapeutic foods in Ethiopia, Ghana, Pakistan and India.","Successful treatment of severe acute malnutrition has been achieved with ready-to-use therapeutic food (RUTF), but only 15% of children with severe acute malnutrition receive RUTF. The objective of this study was to determine whether new formulations of RUTF produced using locally available ingredients were acceptable to young children in Ethiopia, Ghana, Pakistan and India. The local RUTFs were formulated using a linear programming tool that allows for inclusion of only local ingredients and minimizes cost. The study consisted of 4 two-arm, crossover, site-randomized food acceptability trials to test the acceptability of an alternative RUTF formula compared with the standard peanut-based RUTF containing powdered milk. Fifty children with moderate wasting in each country were enrolled in the 2-week study. Acceptability was measured by overall consumption, likeability and adverse effects reported by caregivers. Two of the four RUTFs did not include peanut, and all four used alternative dairy proteins rather than milk. The ingredient cost of all of the RUTFs was about 60% of standard RUTF. In Ethiopia, Ghana and India, the local RUTF was tolerated well without increased reports of rash, diarrhoea or vomiting. Children consumed similar amounts of local RUTF and standard RUTF and preferred them similarly as well. In Pakistan, local RUTF was consumed in similar quantities, but mothers perceived that children did not enjoy it as much as standard RUTF. Our results support the further investigation of these local RUTFs in Ethiopia, Ghana and India in equivalency trials and suggest that local RUTFs may be of lower cost.",2017,"In Ethiopia, Ghana and India, the local RUTF was tolerated well without increased reports of rash, diarrhoea or vomiting.","['young children in Ethiopia, Ghana, Pakistan and India', 'Fifty children with moderate wasting in each country were enrolled in the 2-week study', 'Ethiopia, Ghana, Pakistan and India', 'severe acute malnutrition']","['RUTF', 'alternative RUTF formula compared with the standard peanut-based RUTF containing powdered milk']","['overall consumption, likeability and adverse effects', 'Acceptability', 'rash, diarrhoea or vomiting']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",50.0,0.0726087,"In Ethiopia, Ghana and India, the local RUTF was tolerated well without increased reports of rash, diarrhoea or vomiting.","[{'ForeName': 'Jacklyn M', 'Initials': 'JM', 'LastName': 'Weber', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Kelsey N', 'Initials': 'KN', 'LastName': 'Ryan', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Tandon', 'Affiliation': 'Action Contre La Faim, Baran, India.'}, {'ForeName': 'Meeta', 'Initials': 'M', 'LastName': 'Mathur', 'Affiliation': 'Action Contre La Faim, Baran, India.'}, {'ForeName': 'Tsinuel', 'Initials': 'T', 'LastName': 'Girma', 'Affiliation': 'College of Public Health and Medical Sciences, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Steiner-Asiedu', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Legon, Ghana.'}, {'ForeName': 'Firibu', 'Initials': 'F', 'LastName': 'Saalia', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Legon, Ghana.'}, {'ForeName': 'Shujaat', 'Initials': 'S', 'LastName': 'Zaidi', 'Affiliation': 'Department of Pediatric and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sajid', 'Initials': 'S', 'LastName': 'Soofi', 'Affiliation': 'Department of Pediatric and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Okos', 'Affiliation': 'Agricultural and Biological Engineering Department, Purdue University, West Lafayette, Indiana, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Vosti', 'Affiliation': 'Department of Agricultural and Resource Economics, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Manary', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12250']
832,30282103,Risk of Ischemic Placental Disease in Relation to Family History of Preeclampsia.,"OBJECTIVE


To assess the risk of ischemic placental disease (IPD) including preeclampsia, small for gestational age (SGA), and abruption, in relation to preeclampsia in maternal grandmother, mother, and sister(s).
STUDY DESIGN


We performed a secondary analysis of data from a randomized trial of vitamins C and E for preeclampsia prevention. Data on family history of preeclampsia were based on recall by the proband. The associations between family history of preeclampsia and the odds of IPD were evaluated from alternating logistic regressions.
RESULTS


Of the 9,686 women who delivered nonmalformed, singleton live births, 17.1% had IPD. Probands provided data on preeclampsia in 55.5% ( n  = 5,374) on all three family members, 26.5% ( n  = 2,562) in mother and sister(s) only, and 11.6% ( n  = 1,125) in sister(s) only. The pairwise odds ratio (pOR) of IPD was 1.16 (95% confidence interval [CI]: 1.00-1.36) if one or more of the female relatives had preeclampsia. The pORs of preeclampsia were 1.54 (95% CI: 1.12-2.13) and 1.35 (95% CI: 1.03-1.77) if the proband's mother or sister(s) had a preeclamptic pregnancy, respectively, but no associations were seen for SGA infant or abruption.
CONCLUSION


This study suggests that IPD may share a predisposition with preeclampsia, suggesting a familial inheritance.",2019,"Probands provided data on preeclampsia in 55.5% ( n  = 5,374) on all three family members, 26.5% ( n  = 2,562) in mother and sister(s) only, and 11.6% ( n  = 1,125) in sister(s) only.","['9,686 women who delivered nonmalformed, singleton live births, 17.1% had IPD']",['vitamins C and E'],"['pairwise odds ratio (pOR) of IPD', 'pORs of preeclampsia', 'preeclampsia', 'preeclamptic pregnancy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}]",[],"[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",9686.0,0.106824,"Probands provided data on preeclampsia in 55.5% ( n  = 5,374) on all three family members, 26.5% ( n  = 2,562) in mother and sister(s) only, and 11.6% ( n  = 1,125) in sister(s) only.","[{'ForeName': 'Cande V', 'Initials': 'CV', 'LastName': 'Ananth', 'Affiliation': 'Department of Obstetrics and Gynecology, Vagelos College of Physicians and Surgeons, Joseph L. Mailman School of Public Health, Columbia University, New York, New York.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Jablonski', 'Affiliation': 'Department of Obstetrics and Gynecology, Biostatistics Center, The George Washington University, Washington, District of Columbia.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Myatt', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Roberts', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Leveno', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Varner', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Mercer', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Ramin', 'Affiliation': ""Department of Obstetrics and Gynecology, Children's Memorial Hermann Hospital, The University of Texas Health Science Center at Houston, Houston, Texas.""}, {'ForeName': 'Marshall W', 'Initials': 'MW', 'LastName': 'Carpenter', 'Affiliation': 'Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Samuels', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Sciscione', 'Affiliation': 'Department of Obstetrics and Gynecology, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Tolosa', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Yoram', 'Initials': 'Y', 'LastName': 'Sorokin', 'Affiliation': 'Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of perinatology,['10.1055/s-0038-1672177']
833,30461315,"Effects of Cognitive Behavioral Therapy for Insomnia on Sleep, Symptoms, Stress, and Autonomic Function Among Patients With Heart Failure.","Background : Insomnia is common among patients with stable heart failure (HF) and associated with inflammation and altered autonomic function.  Purpose : The purposes of this study were to examine the effects of cognitive behavioral therapy for insomnia (CBT-I) on the Hypothalamic Pituitary (HPA) Axis, autonomic function, inflammation, and circadian rhythmicity and the associations between these biomarkers and insomnia, sleep characteristics, symptoms, functional performance, and sleep-related cognitions.  Methods : We conducted a subanalysis of a pilot randomized controlled trial (RCT, NCT02827799) whose primary aim was to test the effects of CBT-I on insomnia. We randomized 51 patients with stable Class II-IV HF to CBT-I ( n  = 30) or attention control ( n  = 21). Participants completed wrist actigraphy and self-reported insomnia severity, sleep characteristics, sleep-related cognitions, daytime symptoms, and functional performance. We measured day and nighttime urinary free cortisol, melatonin sulfate, epinephrine, and norepinephrine at baseline, and two weeks after CBT-I and computed general linear models and partial correlations.  Results : CBT-I had no effects on the biomarkers, but there were statistically significant negative cross-sectional correlations between the ratio of day and night urinary free cortisol and sleep disturbance, anxiety, fatigue, depression, and negative sleep cognitions. Increases in the ratio between day and night cortisol were associated with statistically significant improvements in fatigue, depression, sleep duration, and sleep-related cognitions.  Conclusions : Biomarkers of stress and autonomic function are associated with sleep, sleep-related symptoms, and cognitions among people with chronic HF. Future studies are needed to identify potential causal relationships and the impact of sleep interventions.",2020,"Increases in the ratio between day and night cortisol were associated with statistically significant improvements in fatigue, depression, sleep duration, and sleep-related cognitions.
","['Patients With Heart Failure', 'people with chronic HF', 'patients with stable heart failure (HF', '51 patients with stable Class II-IV HF to CBT-I (n =\xa030) or attention control (n =\xa021']","['Cognitive Behavioral Therapy', 'cognitive behavioral therapy']","['wrist actigraphy and self-reported insomnia severity, sleep characteristics, sleep-related cognitions, daytime symptoms, and functional performance', 'Hypothalamic Pituitary (HPA) Axis, autonomic function, inflammation, and circadian rhythmicity and the associations between these biomarkers and insomnia, sleep characteristics, symptoms, functional performance, and sleep-related cognitions', 'Insomnia on Sleep, Symptoms, Stress, and Autonomic Function', 'nighttime urinary free cortisol, melatonin sulfate, epinephrine, and norepinephrine', 'fatigue, depression, sleep duration, and sleep-related cognitions', 'night urinary free cortisol and sleep disturbance, anxiety, fatigue, depression, and negative sleep cognitions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3853978'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0031084', 'cui_str': 'Rhythmicity'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine (procedure)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",51.0,0.03938,"Increases in the ratio between day and night cortisol were associated with statistically significant improvements in fatigue, depression, sleep duration, and sleep-related cognitions.
","[{'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Redeker', 'Affiliation': 'Beatrice Renfield Term Professor of Nursing, Yale School of Nursing, West Haven, Connecticut.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Conley', 'Affiliation': 'Yale School of Nursing, Orange, CT.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Anderson', 'Affiliation': 'Yale Child Study Center, New Haven, CT.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cline', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Andrews', 'Affiliation': 'Yale School of Nursing, Orange, CT.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mohsenin', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Sangchoon', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'Yale School of Nursing, Orange, CT.'}]",Behavioral sleep medicine,['10.1080/15402002.2018.1546709']
834,30566590,"Safety and efficacy of nivolumab in combination with S-1/capecitabine plus oxaliplatin in patients with previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: interim results of a randomized, phase II trial (ATTRACTION-4).","BACKGROUND


Nivolumab is approved as an option for third- or later-line treatment of advanced gastric/gastroesophageal junction (G/GEJ) cancer in several countries after ATTRACTION-2. To further improve the therapeutic efficacy of first-line therapy, exploration of a nivolumab-chemotherapy combination is warranted. In part 1 (phase II) of ATTRACTION-4, the safety and efficacy of nivolumab combined with S-1 plus oxaliplatin (SOX) or capecitabine plus oxaliplatin (CapeOX) as first-line therapy for unresectable advanced or recurrent human epidermal growth factor receptor 2 (HER2)-negative G/GEJ cancer were evaluated.
PATIENTS AND METHODS


Patients were randomized (1 : 1) to receive nivolumab (360 mg intravenously every 3 weeks) plus SOX (S-1, 40 mg/m2 orally twice daily for 14 days followed by 7 days off; oxaliplatin, 130 mg/m2 intravenously on day 1 every 3 weeks) or CapeOX (capecitabine, 1000 mg/m2 orally twice daily for 14 days followed by 7 days off; oxaliplatin, 130 mg/m2 intravenously on day 1 every 3 weeks) until disease progression, unacceptable toxicity, or consent withdrawal.
RESULTS


Of 40 randomized patients, 39 (nivolumab plus SOX, 21; nivolumab plus CapeOX, 18) and 38 (21 and 17, respectively) comprised the safety and efficacy populations, respectively. Most frequent (>10%) grade 3/4 treatment-related adverse events were neutropenia (14.3%) in the nivolumab plus SOX group, and neutropenia (16.7%), anemia, peripheral sensory neuropathy, decreased appetite, type 1 diabetes mellitus, and nausea (11.1% each) in the nivolumab plus CapeOX group. No treatment-related death occurred. Objective response rate was 57.1% (95% confidence interval 34.0-78.2) with nivolumab plus SOX and 76.5% (50.1-93.2) with nivolumab plus CapeOX. Median overall survival was not reached (NR) in both groups. Median progression-free survival was 9.7 months (5.8-NR) and 10.6 months (5.6-12.5), respectively.
CONCLUSION


Nivolumab combined with SOX/CapeOX was well tolerated and demonstrated encouraging efficacy for unresectable advanced or recurrent HER2-negative G/GEJ cancer. ATTRACTION-4 has proceeded to part 2 (phase III) to compare nivolumab plus SOX/CapeOX versus placebo plus SOX/CapeOX.
CLINICALTRIALS.GOV ID


NCT02746796.",2019,Objective response rate was 57.1% (95% confidence interval 34.0-78.2) with nivolumab plus SOX and 76.5% (50.1-93.2) with nivolumab plus CapeOX.,"['Patients were randomized ', '40 randomized patients, 39', 'unresectable advanced or recurrent human epidermal growth factor receptor 2 (HER2)-negative G/GEJ cancer', 'patients with previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer']","['nivolumab combined with S-1 plus oxaliplatin (SOX) or capecitabine plus oxaliplatin (CapeOX', 'S-1/capecitabine plus oxaliplatin', 'nivolumab', 'Nivolumab combined with SOX/CapeOX', 'oxaliplatin', 'CapeOX (capecitabine, 1000', 'nivolumab-chemotherapy combination']","['anemia, peripheral sensory neuropathy, decreased appetite, type 1 diabetes mellitus, and nausea', 'Objective response rate', 'neutropenia', 'therapeutic efficacy', 'Median progression-free survival', 'Median overall survival', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",40.0,0.202282,Objective response rate was 57.1% (95% confidence interval 34.0-78.2) with nivolumab plus SOX and 76.5% (50.1-93.2) with nivolumab plus CapeOX.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'M-H', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'Department of Medical Oncology, Yonsei Cancer Center, Song Dang Institute for Cancer Research, Yonsei University College of Medicine, Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Minashi', 'Affiliation': 'Clinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'K-W', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital, Tokyo, Japan (previously Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Kang', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Komatsu', 'Affiliation': 'Division of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tsuda', 'Affiliation': 'Department of Gastroenterological Oncology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastroenterology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fumita', 'Affiliation': 'Department of Medical Oncology, Nara Hospital Kindai University, Ikoma, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Azuma', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'L-T', 'Initials': 'LT', 'LastName': 'Chen', 'Affiliation': 'National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan; Department of Internal Medicine, National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Y-K', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Electronic address: ykkang@amc.seoul.kr.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdy540']
835,31326995,Plaque burden can be assessed using intravascular optical coherence tomography and a dedicated automated processing algorithm: a comparison study with intravascular ultrasound.,"AIMS


Plaque burden (PB) measurement using intravascular optical coherence tomography (IVOCT) is currently thought to be inferior to intravascular ultrasound (IVUS). We developed an automated IVOCT image processing algorithm to enhance the external elastic lamina (EEL) contour. Thus, we investigated the accuracies of standard IVOCT and an IVOCT enhancement algorithm for measuring PB using IVUS as the reference standard.
METHODS AND RESULTS


The EEL-enhancement algorithm combined adaptive attenuation compensation, exponentiation, angular registration, and image averaging using three sequential frames. In two different laboratories with intravascular imaging expertise, PB was quantified on 200 randomized, matched IVOCT and IVUS images by four independent observers. Fibroatheroma, fibrocalcific plaque, fibrous plaque, pathological intimal thickening (PIT), and mixed plaque were included in each set. Pearson's correlation coefficients between IVUS and standard IVOCT measurements of PB were 0.61, 0.67, 0.76, 0.78, and 0.87 for fibroatheromas, mixed plaques, fibrocalcific plaques, fibrous plaques, and PIT plaques, respectively. Pearson's correlation coefficients increased to 0.81, 0.83, 0.83, 0.84, and 0.90 when using the EEL-enhanced images (P = 0.003, P = 0.004, P = 0.08, P = 0.12, and P = 0.23, respectively). EEL-enhanced IVOCT analysis was associated with a lower EEL-area measurement absolute error for fibroatheromas, mixed plaques, and all pooled plaques (P = 0.006, P = 0.02, and P < 0.001, respectively). Compared with standard IVOCT, the EEL-enhanced IVOCT images had a higher sensitivity (79% vs. 28%, P < 0.001) and specificity (98% vs. 85%, P = 0.03) for plaques with an IVUS PB ≥70%.
CONCLUSION


EEL-enhanced IVOCT can be used to reliably measure PB in all types of coronary atherosclerotic lesions, including fibroatheromas and mixed plaques.",2020,"EEL-enhanced IVOCT analysis was associated with a lower EEL-area measurement absolute error for fibroatheromas, mixed plaques, and all pooled plaques (P = 0.006, P = 0.02, and P < 0.001, respectively).",[],"['EEL-enhanced IVOCT', 'intravascular optical coherence tomography (IVOCT']","['mixed plaques, fibrocalcific plaques, fibrous plaques, and PIT plaques', 'IVUS and standard IVOCT measurements of PB', 'higher sensitivity', 'Fibroatheroma, fibrocalcific plaque, fibrous plaque, pathological intimal thickening (PIT), and mixed plaque', 'specificity']",[],"[{'cui': 'C0013671', 'cui_str': 'Anguilliformes'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0334146', 'cui_str': 'Fibrous plaque (morphologic abnormality)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C2936351', 'cui_str': 'Fibroatheromatous Plaques'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C3495932', 'cui_str': 'Intimal thickening'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",200.0,0.0522334,"EEL-enhanced IVOCT analysis was associated with a lower EEL-area measurement absolute error for fibroatheromas, mixed plaques, and all pooled plaques (P = 0.006, P = 0.02, and P < 0.001, respectively).","[{'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Gerbaud', 'Affiliation': 'Wellman Center for Photomedicine, Harvard Medical School and Massachusetts General Hospital, 40 Blossom Street, BHX-604A, Boston, MA 02114, USA.'}, {'ForeName': 'Giora', 'Initials': 'G', 'LastName': 'Weisz', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Wellman Center for Photomedicine, Harvard Medical School and Massachusetts General Hospital, 40 Blossom Street, BHX-604A, Boston, MA 02114, USA.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Luu', 'Affiliation': 'Wellman Center for Photomedicine, Harvard Medical School and Massachusetts General Hospital, 40 Blossom Street, BHX-604A, Boston, MA 02114, USA.'}, {'ForeName': 'Hany Ahmed Salaheldin Hussein', 'Initials': 'HASH', 'LastName': 'Osman', 'Affiliation': 'Wellman Center for Photomedicine, Harvard Medical School and Massachusetts General Hospital, 40 Blossom Street, BHX-604A, Boston, MA 02114, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Baldwin', 'Affiliation': 'Wellman Center for Photomedicine, Harvard Medical School and Massachusetts General Hospital, 40 Blossom Street, BHX-604A, Boston, MA 02114, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Coste', 'Affiliation': 'Cardiology Intensive Care Unit and Interventional Cardiology, Hôpital Cardiologique du Haut Lévêque, 5 Avenue Magellan, Pessac 33600, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Cognet', 'Affiliation': ""Institut d'Optique Graduate School, CNRS-UMR 5298, Bordeaux University, Rue François Miterrand, Talence 33400, France.""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Waxman', 'Affiliation': 'Department of Cardiology, Lahey Clinic Medical Center, 41 Mall Road, Burlington, MA 01805, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Moses', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Mintz', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Akasaka', 'Affiliation': 'Department of Cardiovascular Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Guillermo J', 'Initials': 'GJ', 'LastName': 'Tearney', 'Affiliation': 'Wellman Center for Photomedicine, Harvard Medical School and Massachusetts General Hospital, 40 Blossom Street, BHX-604A, Boston, MA 02114, USA.'}]",European heart journal cardiovascular Imaging,['10.1093/ehjci/jez185']
836,30160168,"Quantitative T2 MRI Mapping and 12-Month Follow-up in a Randomized, Blinded, Placebo Controlled Trial of Bone Marrow Aspiration and Concentration for Osteoarthritis of the Knees.","OBJECTIVE


Bone marrow aspiration and concentration (BMAC) is becoming a more common regenerative therapy for musculoskeletal pathology. In our current pilot study, we studied patients with mild-to-moderate bilateral knee osteoarthritis, compared pain at 12-month follow-up between BMAC-injected and saline-injected knees, and examined cartilage appearance measured by magnetic resonance imaging (MRI) T2 quantitative mapping.
DESIGN


Twenty-five patients with mild-to-moderate bilateral osteoarthritic knee pain were randomized to receive BMAC into one knee and saline placebo into the other. Bone marrow was aspirated from the iliac crests, concentrated in an automated centrifuge, combined with platelet-poor plasma for knee injection, and compared with saline injection into the contralateral knee. Primary outcome measures were T2 MRI cartilage mapping at 6-month and Visual Analog Scale and Osteoarthritis Research Society International Intermittent and Constant Osteoarthritis Pain scores and radiographs at 12-month follow-up.
RESULTS


Constant, intermittent, and overall knee pain remained significantly decreased from baseline at 12-month follow-up (all  P  ⩽ 0.01), with no apparent difference between BMAC- and saline-treated knees (all  P  ⩾ 0.54). A similar significant increase from baseline to 12-month follow-up regarding quality of life was observed for both BMAC- and saline-treated knees (all  P  ⩽ 0.04). T2 quantitative MRI mapping showed no significant changes as a result of treatment.
CONCLUSIONS


BMAC is safe to perform and relieves pain from knee arthritis but showed no superiority to saline injection at 12-month follow-up. MRI cartilage sequences failed to show regenerative benefit with single BMAC injection. The mechanisms of action that led to pain relief remain unclear and warrant further studies.",2019,A similar significant increase from baseline to 12-month follow-up regarding quality of life was observed for both BMAC- and saline-treated knees (all P ⩽ 0.04).,"['Design Twenty-five patients with mild-to-moderate bilateral osteoarthritic knee pain', 'Osteoarthritis of the Knees', 'patients with mild-to-moderate bilateral knee osteoarthritis, compared pain at 12-month follow-up between']","['BMAC-injected and saline-injected knees, and examined cartilage appearance measured by magnetic resonance imaging (MRI) T2 quantitative mapping', 'Placebo', 'Bone Marrow Aspiration', 'BMAC into one knee and saline placebo', 'Objective Bone marrow aspiration and concentration (BMAC']","['overall knee pain', 'quality of life', 'T2 MRI cartilage mapping at 6-month and Visual Analog Scale and Osteoarthritis Research Society International Intermittent and Constant Osteoarthritis Pain scores and radiographs']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0398523', 'cui_str': 'Bone marrow aspiration procedure'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0035168'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}]",25.0,0.107449,A similar significant increase from baseline to 12-month follow-up regarding quality of life was observed for both BMAC- and saline-treated knees (all P ⩽ 0.04).,"[{'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Shapiro', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Arthurs', 'Affiliation': 'Division of Transplant Medicine, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Heckman', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Bestic', 'Affiliation': 'Department of Radiology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Shari E', 'Initials': 'SE', 'LastName': 'Kazmerchak', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Nancy N', 'Initials': 'NN', 'LastName': 'Diehl', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Abba C', 'Initials': 'AC', 'LastName': 'Zubair', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Mary I', 'Initials': 'MI', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Orthopedic Surgery, Yale-New Haven Hospital, New Haven, CT, USA.'}]",Cartilage,['10.1177/1947603518796142']
837,31896735,Comparing treatment effects of a convenient vibratory positional device to CPAP in positional OSA: a crossover randomised controlled trial.,"OBJECTIVES


Up to 77% of patients with obstructive sleep apnoea (OSA) have positional OSA (POSA) but traditional positional therapy (PT) methods have failed as they were poorly tolerated. New convenient vibratory PT devices have been invented but while recent studies suggest high treatment efficacy and adherence, there are no published data comparing these devices directly with continuous positive airway pressure (CPAP). Our objective is to evaluate if a convenient vibratory PT device is non-inferior to CPAP in POSA treatment.
METHODS


In this crossover randomised controlled trial, we enrolled patients with POSA with significant daytime sleepiness (Epworth Sleepiness Scale (ESS)≥10). POSA diagnosis was based on: (1) total Apnoea/Hypopnoea Index (AHI)>10/hour and non-supine AHI<10/hour (2) supine AHI≥2 × non-supine AHI. Patients used their initial allocated devices (PT or CPAP) for 8 weeks before crossing to the alternative intervention after a 1 week washout. The primary aim is to measure changes in ESS between the two treatments. Secondary outcomes include sleep study parameters and patient treatment preference (ClinicalTrials.gov: NCT03125512).
RESULTS


40 patients completed the trial between April 2017 and December 2018. Difference in ESS after 8 weeks of device use (PT minus CPAP) was 2.0 (95% CI 0.68 to 3.32), exceeding our predetermined non-inferiority margin of 1.5. AHI on CPAP was lower than with PT (4.0±3.2 vs 13.0±13.8 events/hour, respectively, p=0.001), although both were lower than at baseline. Time spent supine was significantly lower with PT than CPAP (p<0.001). 60% of patients preferred CPAP, 20% preferred PT, while 20% preferred neither device.
CONCLUSIONS


The non-inferiority ESS endpoint for PT compared with CPAP was not met and the results were inconclusive. Future trials with larger sample sizes or in less symptomatic patients are warranted to provide further insight into the role of these new vibratory PT devices.",2020,Time spent supine was significantly lower with PT than CPAP (p<0.001).,"['40 patients completed the trial between April 2017 and December 2018', 'patients with obstructive sleep apnoea (OSA) have positional OSA (POSA) but', 'positional OSA', 'enrolled patients with POSA with significant daytime sleepiness (Epworth Sleepiness Scale (ESS)≥10']","['initial allocated devices (PT or CPAP', 'convenient vibratory positional device to CPAP', 'traditional positional therapy (PT', 'CPAP']","['Time spent supine', 'AHI on CPAP', 'ESS', 'total Apnoea/Hypopnoea Index (AHI)>10/hour', 'sleep study parameters and patient treatment preference (ClinicalTrials.gov: NCT03125512']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C3831015', 'cui_str': 'Convenient (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",40.0,0.0527833,Time spent supine was significantly lower with PT than CPAP (p<0.001).,"[{'ForeName': 'Yingjuan', 'Initials': 'Y', 'LastName': 'Mok', 'Affiliation': 'Department of Sleep Medicine, Surgery and Science, Changi General Hospital, Singapore, Singapore mok.yingjuan@singhealth.com.sg.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'Department of Sleep Medicine, Surgery and Science, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Pon Poh', 'Initials': 'PP', 'LastName': 'Hsu', 'Affiliation': 'Department of Sleep Medicine, Surgery and Science, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Seow', 'Affiliation': 'Allied Health Division, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Yiong Huak', 'Initials': 'YH', 'LastName': 'Chan', 'Affiliation': 'Biostatistics Unit, Yong Loo Lin School of Medicine, National University Singapore, Singapore, Singapore.'}, {'ForeName': 'Hang Siang', 'Initials': 'HS', 'LastName': 'Wong', 'Affiliation': 'Department of Sleep Medicine, Surgery and Science, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Poh', 'Affiliation': 'Allied Health Division, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Keith K H', 'Initials': 'KKH', 'LastName': 'Wong', 'Affiliation': 'Department of Respiratory & Sleep Medicine, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}]",Thorax,['10.1136/thoraxjnl-2019-213547']
838,30538282,Prefronto-cerebellar neuromodulation affects appetite in obesity.,"Human neuroimaging studies have consistently reported changes in cerebellar function and integrity in association with obesity. To date, however, the nature of this link has not been studied directly. Emerging evidence suggests a role for the cerebellum in higher cognitive functions through reciprocal connections with the prefrontal cortex. The purpose of this exploratory study was to examine appetite changes associated with noninvasive prefronto-cerebellar neuromodulation in obesity. Totally, 12 subjects with class I obesity (mean body mass index 32.9 kg/m 2 ) underwent a randomized, single-blinded, sham-controlled, crossover study, during which they received transcranial direct current stimulation ((tDCS); active/sham) aimed at simultaneously enhancing the activity of the prefrontal cortex and decreasing the activity of the cerebellum. Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated. We found that active tDCS caused an increase in hunger and desire to eat following food-cue exposure. In line with these data, subjects also tended to make more errors during the working memory task. No changes in basic motor performance occurred. This study represents the first demonstration that prefronto-cerebellar neuromodulation can influence appetite in individuals with obesity. While preliminary, our findings support a potential role for prefronto-cerebellar pathways in the behavioral manifestations of obesity.",2019,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"['individuals with obesity', '12 subjects with class']","['transcranial direct current stimulation ((tDCS); active/sham', 'active tDCS', 'prefronto-cerebellar neuromodulation', 'Prefronto-cerebellar neuromodulation']","['basic motor performance', 'appetite (state and food-cue-triggered) and performance', 'hunger and desire to eat']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",12.0,0.0223505,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Marron', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain. emunozmarr@uoc.edu.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Viejo-Sobera', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Cuatrecasas', 'Affiliation': 'Endocrinology Department, Clínica Sagrada Familia. Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Redolar-Ripoll', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Pilar García', 'Initials': 'PG', 'LastName': 'Lorda', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Soterix Medical, New York City, NY, USA.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, City College of New York (CCNY), New York, NY, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. malonso@bidmc.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0278-8']
839,30568260,Personalized nutrition: pretreatment glucose metabolism determines individual long-term weight loss responsiveness in individuals with obesity on low-carbohydrate versus low-fat diet.,"BACKGROUND/OBJECTIVES


The interaction between fasting plasma glucose (FPG) and fasting insulin (FI) concentrations and diets with different carbohydrate content were studied as prognostic markers of weight loss as recent studies up to 6 months of duration have suggested the importance of these biomarkers.
SUBJECTS/METHODS


This was a retrospective analysis of a clinical trial where participants with obesity were randomized to an ad libitum low-carbohydrate diet or a low-fat diet with low energy content (1200-1800 kcal/day [≈ 5.0-7.5 MJ/d]; ≤ 30% calories from fat) for 24 months. Participants were categorized (pretreatment) as normoglycemic (FPG < 5.6 mmol/L) or prediabetic (FPG ≥ 5.6-6.9 mmol/L) and further stratified by median FI. Linear mixed models were used to examine outcomes by FPG and FI values.
RESULTS


After 2 years, participants with prediabetes and high FI lost 7.2  kg (95% CI 2.1;12.2, P = 0.005) more with the low-fat than low-carbohydrate diet, whereas those with prediabetes and low FI tended to lose 6.2  kg (95% CI -0.9;13.3, P = 0.088) more on the low-carbohydrate diet than low-fat diet [mean difference: 13.3 kg (95% CI 4.6;22.0, P = 0.003)]. No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
CONCLUSIONS


Fasting plasma glucose and insulin are strong predictors of the weight loss response to diets with different macronutrient composition and might be a useful approach for personalized weight management.",2019,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","['Participants were categorized (pretreatment) as normoglycemic (FPG\u2009<\u20095.6\u2009mmol/L) or prediabetic (FPG\u2009≥\u20095.6-6.9\u2009mmol/L) and further stratified by median FI', 'individuals with obesity on low-carbohydrate versus low-fat diet', 'participants with obesity']",['ad libitum low-carbohydrate diet or a low-fat diet with low energy content'],['fasting plasma glucose (FPG) and fasting insulin (FI) concentrations'],"[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0200382,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","[{'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark. madsfiil@nexs.ku.dk.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Yishai', 'Initials': 'Y', 'LastName': 'Zohar', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'Lorien E', 'Initials': 'LE', 'LastName': 'Urban', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'R Drew', 'Initials': 'RD', 'LastName': 'Sayer', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Babette S', 'Initials': 'BS', 'LastName': 'Zemel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",International journal of obesity (2005),['10.1038/s41366-018-0298-4']
840,32210687,Therapeutic effect of autologous bone marrow stem cell mobilization combined with anti-infective therapy on moyamoya disease.,"Objective


The purpose of this study is to explore the therapeutic effect of autologous bone marrow stem cell (ABMSC) mobilization combined anti-infection therapy on patients with moyamoya disease (MMD), and to provide reference for the clinical treatment of MMD and cerebrovascular disease.
Methods


54 adult patients with MMD diagnosed in Henan Provincial People's Hospital from March 2017 to March 2019 were chosen as research objects. All patients were randomly divided into study group (SG) and control group (CG), with 27 patients in each group. Patients in both groups received conventional drug treatment after diagnosis of MMD, and received dura turnover of brain - temporal muscle - superficial temporal artery application surgery during indirect vascular reconstruction. On the basis of surgical treatment, patients in the SG were given ABMSC mobilization combined with low-dose dexamethasone for anti-inflammatory and anti-infection treatment. ABMSCs were mobilized by recombinant human granulocyte colony stimulating factor (rhG-csF) and recombinant human granulocyte - macrophage colony stimulating factor (rhoM-esF). The therapeutic effects of the patients were evaluated BF, one month after treatment (AF), three months AF, and six months AF. The number of hematopoietic stem cells (HpCs) and inflammatory indicators were compared between the two groups before and 4 weeks AF.
Results


Firstly, the Barthcl index of patients in the two groups showed a gradual increase trend at the 3rd and 6th months AF, and the ascensional range in the research group was higher than that in the CG (P < 0.05). Secondly, at the 3rd and 6th month AF, national institute of heath stroke scale (NIHSS) scores of patients in the CG were lower than those before treatment (BF), and there was an important change in NIHSS scores between the two groups at the same period (P < 0.05). Thirdly, after 1 month of treatment and 3 months of treatment, Chinese stroke scale (CSS) scores of patients in both groups decreased obviously compared with those BF, and the SG was lower than the CG, with statistical changes (P < 0.05). Fourthly, after 4 weeks of treatment, the hematopoietic stem cell counts in both groups were higher than those BF, and the hematopoietic stem cell counts in the SG were obviously higher than those in the CG (P < 0.05). All three inflammatory indicators were improved compared with those BF, and the SG was better than the CG (P < 0.05).
Conclusion


Autogenous bone marrow stem cell mobilization combined with dexamethasone anti-inflammation and anti-infection treatment after revascularization in patients with MMD can accelerate the recovery of nerve function and promote the formation of new blood vessels. At the same time, it can reduce inflammation and improve patients' quality of life, which is worthy of clinical reference.",2020,"The number of hematopoietic stem cells (HpCs) and inflammatory indicators were compared between the two groups before and 4 weeks AF.
","[""54 adult patients with MMD diagnosed in Henan Provincial People's Hospital from March 2017 to March 2019 were chosen as research objects"", 'patients with moyamoya disease (MMD', 'moyamoya disease', 'patients with MMD']","['Autogenous bone marrow stem cell mobilization combined with dexamethasone', 'ABMSC mobilization combined with low-dose dexamethasone', 'autologous bone marrow stem cell (ABMSC) mobilization combined anti-infection therapy', 'conventional drug treatment after diagnosis of MMD, and received dura turnover of brain - temporal muscle - superficial temporal artery application surgery during indirect vascular reconstruction', 'autologous bone marrow stem cell mobilization combined with anti-infective therapy', 'CG (P']","['Chinese stroke scale (CSS) scores', 'number of hematopoietic stem cells (HpCs) and inflammatory indicators', 'ascensional range', 'hematopoietic stem cell counts', 'NIHSS scores', 'national institute of heath stroke scale (NIHSS) scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035168'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0026654', 'cui_str': 'Cerebrovascular Moyamoya Disease'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0524864', 'cui_str': 'Stem Cell Mobilization'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0039487', 'cui_str': 'Temporal Muscle'}, {'cui': 'C0226130', 'cui_str': 'Structure of superficial temporal artery'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C1141958', 'cui_str': 'Anti-infective therapy'}]","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}]",54.0,0.0158499,"The number of hematopoietic stem cells (HpCs) and inflammatory indicators were compared between the two groups before and 4 weeks AF.
","[{'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurosurgery, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Weiliang', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': ""Department of Neurosurgery, Henan University People's Hospital, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': ""Department of Neurosurgery, Henan University People's Hospital, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Gao', 'Affiliation': ""Department of Neurosurgery, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Yuxue', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Neurosurgery, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Shao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Henan University People's Hospital, Zhengzhou, Henan 450003, China.""}, {'ForeName': 'Chaoyue', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Neurosurgery, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, Henan 450003, China.""}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2019.12.016']
841,31342533,"Improvement of non-invasive markers of NAFLD from an individualised, web-based exercise program.","BACKGROUND


Lifestyle modifications remain the cornerstone of treatment in non-alcoholic fatty liver disease (NAFLD). However, they requently fail related to the inability of patients to implement lasting changes.
AIMS


To evaluate the effects of a short, web-based, individualised exercise program on non-invasive markers of hepatic steatosis, inflammation and fibrosis.
METHODS


Patients with histologically confirmed NAFLD underwent an 8-week, web-based, individualised exercise program that contained bidirectional feedback.
RESULTS


Forty-four patients entered the study and 41 completed the assigned training goal (93.2%). In the completer population, 8 weeks of individualised exercise increased the VO 2peak  by 12.2% compared to baseline (P < .001). ALT and AST decreased by 14.3% (P = .002) and 18.2% (P < .001) and remained at this level until follow-up 12 weeks after the intervention. Markers of inflammation including hsCRP, ferritin, and M30 decreased. In parallel, gut microbiota exhibited increased metagenomic richness (P < .05) and at the taxonomic levels Bacteroidetes and Euryarchaeota increased whereas Actinobacteria phylum decreased. Surrogate scores of steatosis and fibrosis including the fatty liver index (FLI), FiB-4, APRI and transient elastography showed significant reductions. In parallel, a marker of procollagen-3 turnover (PRO-C3) decreased while C4M2, reflecting type IV collagen, degradation increased suggesting beneficial hepatic fibrosis remodelling from exercise. Also, an enhancement in health-related quality of life was reported.
CONCLUSION


The current study underlines the plausibility and potential of an 8 week individualised web-based exercise program in NAFLD. Clinical trial number: NCT02526732.",2019,"In parallel, gut microbiota exhibited increased metagenomic richness (P < .05) and at the taxonomic levels Bacteroidetes and Euryarchaeota increased whereas Actinobacteria phylum decreased.","['non-alcoholic fatty liver disease (NAFLD', 'Patients with histologically confirmed NAFLD underwent an 8-week, web-based', 'Forty-four patients entered the study and 41 completed the assigned training goal (93.2']","['individualised exercise program that contained bidirectional feedback', 'individualised exercise program']","['VO 2peak', 'taxonomic levels Bacteroidetes and Euryarchaeota', 'metagenomic richness', 'hepatic steatosis, inflammation and fibrosis', 'health-related quality of life', 'ALT and AST', 'Surrogate scores of steatosis and fibrosis including the fatty liver index (FLI), FiB-4, APRI and transient elastography']","[{'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0995456', 'cui_str': 'Bacteroidetes'}, {'cui': 'C0524822', 'cui_str': 'Euryarchaeota'}, {'cui': 'C2717799', 'cui_str': 'Population Genomics'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}]",44.0,0.102523,"In parallel, gut microbiota exhibited increased metagenomic richness (P < .05) and at the taxonomic levels Bacteroidetes and Euryarchaeota increased whereas Actinobacteria phylum decreased.","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Huber', 'Affiliation': 'Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pfirrmann', 'Affiliation': 'Department of Sports Medicine, Rehabilitation and Prevention, Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Gebhardt', 'Affiliation': 'Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Labenz', 'Affiliation': 'Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Gehrke', 'Affiliation': 'Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Beate K', 'Initials': 'BK', 'LastName': 'Straub', 'Affiliation': 'Institute of Pathology, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ruckes', 'Affiliation': 'Interdisciplinary Centre for Clinical Trials (IZKS), University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Bantel', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Belda', 'Affiliation': 'Integromics team, Institute of cardiometabolism and Nutrition, Paris, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Clément', 'Affiliation': 'Nutrition Department, Pitié-Salpêtrière Hospital, Assistance Publique Hôpitaux de Paris, Sorbonne Université, INSERM, NutriOmics Research Team, Paris, France.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Leeming', 'Affiliation': 'Nordic Bioscience Biomarkers and Research A/S, Herlev, Denmark.'}, {'ForeName': 'Morten A', 'Initials': 'MA', 'LastName': 'Karsdal', 'Affiliation': 'Nordic Bioscience Biomarkers and Research A/S, Herlev, Denmark.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': 'Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Perikles', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Department of Sports Medicine, Rehabilitation and Prevention, Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Jörn M', 'Initials': 'JM', 'LastName': 'Schattenberg', 'Affiliation': 'Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15427']
842,32217780,Cost-effectiveness of positive airway pressure modalities in obesity hypoventilation syndrome with severe obstructive sleep apnoea.,"BACKGROUND


Obesity hypoventilation syndrome (OHS) is treated with either non-invasive ventilation (NIV) or CPAP, but there are no long-term cost-effectiveness studies comparing the two treatment modalities.
OBJECTIVES


We performed a large, multicentre, randomised, open-label controlled study to determine the comparative long-term cost and effectiveness of NIV versus CPAP in patients with OHS with severe obstructive sleep apnoea (OSA) using hospitalisation days as the primary outcome measure.
METHODS


Hospital resource utilisation and within trial costs were evaluated against the difference in effectiveness based on the primary outcome (hospitalisation days/year, transformed and non-transformed in monetary term). Costs and effectiveness were estimated from a log-normal distribution using a Bayesian approach. A secondary analysis by adherence subgroups was performed.
RESULTS


In total, 363 patients were selected, 215 were randomised and 202 were available for the analysis. The median (IQR) follow-up was 3.01 (2.91-3.14) years for NIV group and 3.00 (2.92-3.17) years for CPAP. The mean (SD) Bayesian estimated hospital days was 2.13 (0.73) for CPAP and 1.89 (0.78) for NIV. The mean (SD) Bayesian estimated cost per patient/year in the NIV arm, excluding hospitalisation costs, was €2075.98 (91.6), which was higher than the cost in the CPAP arm of €1219.06 (52.3); mean difference €857.6 (105.5). CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs. Similar findings were observed in the high and low adherence subgroups.
CONCLUSION


CPAP is more cost-effective than NIV; therefore, CPAP should be the preferred treatment for patients with OHS with severe OSA.
TRIAL REGISTRATION NUMBER


NCT01405976.",2020,CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs.,"['363 patients were selected, 215 were randomised and 202 were available for the analysis', 'obesity hypoventilation syndrome with severe obstructive sleep apnoea', 'patients with OHS with severe OSA', 'patients with OHS with severe obstructive sleep apnoea (OSA']","['CPAP', 'non-invasive ventilation (NIV) or CPAP', 'NIV versus CPAP', 'positive airway pressure modalities']","['mean (SD) Bayesian estimated cost per patient/year in the NIV arm, excluding hospitalisation costs', 'Costs and effectiveness', 'hospital stay', 'mean (SD) Bayesian estimated hospital days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0031880', 'cui_str': 'Obesity Hypoventilation Syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",363.0,0.132362,CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs.,"[{'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Masa', 'Affiliation': 'Respiratory Department, San Pedro de Alcantara Hospital, Caceres, Spain fmasa@separ.es.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Mokhlesi', 'Affiliation': 'Instituto Universitario deInvestigación Biosanitaria de Extremadura (INUBE), Romero, Auxiliadora.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Benítez', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Gómez de Terreros Caro', 'Affiliation': 'Respiratory Department, San Pedro de Alcantara Hospital, Caceres, Spain.'}, {'ForeName': 'M-Ángeles', 'Initials': 'MÁ', 'LastName': 'Sánchez-Quiroga', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Auxiliadora', 'Initials': 'A', 'LastName': 'Romero', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Candela', 'Initials': 'C', 'LastName': 'Caballero', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Maria Luz', 'Initials': 'ML', 'LastName': 'Alonso-Álvarez', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Ordax-Carbajo', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gómez-García', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'González', 'Affiliation': 'Respiratory Department, Valdecilla Hospital, Santander, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'López-Martín', 'Affiliation': 'Respiratory Department, Gregorio Marañon Hospital, Madrid, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Marin', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Martí', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Díaz-Cambriles', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Eusebi', 'Initials': 'E', 'LastName': 'Chiner', 'Affiliation': 'Respiratory Department, San Juan Hospital, Alicante, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Egea', 'Affiliation': 'Respiratory Department, Gregorio Marañon Hospital, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Barca', 'Affiliation': 'Institut de Recerca Biomédica de LLeida (IRBLLEIDA), Lleida, Spain.'}, {'ForeName': 'Francisco-José', 'Initials': 'FJ', 'LastName': 'Vázquez-Polo', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Negrín', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martel-Escobar', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Barbé', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Corral-Peñafiel', 'Affiliation': 'Respiratory Department, San Pedro de Alcantara Hospital, Caceres, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thorax,['10.1136/thoraxjnl-2019-213622']
843,31499228,Communication and coping intervention for mothers of adolescents with type 1 diabetes: Rationale and trial design.,"Mothers of adolescents with type 1 diabetes (T1D) experience high rates of depressive symptoms and diabetes distress, which are established risk factors for deteriorating glycemic control, problems with adherence, increased depressive symptoms, and poor quality of life in adolescents. Given that adolescents are a high-risk population for suboptimal glycemic control, novel interventions to improve outcomes in adolescents with T1D are needed. Building on effective interventions to treat depression in adults, and our own pilot work in this population, we developed a cognitive behavioral intervention, Communication & Coping, to target maternal depressive symptoms and parenting behaviors. The randomized controlled trial compares the telephone and Facebook-delivered Communication & Coping intervention, which promotes the use of adaptive coping strategies and positive parenting practices, to a diabetes education control condition on diabetes outcomes and psychosocial outcomes in adolescents with T1D. This paper describes the study rationale, trial design, and methodology.",2019,"The randomized controlled trial compares the telephone and Facebook-delivered Communication & Coping intervention, which promotes the use of adaptive coping strategies and positive parenting practices, to a diabetes education control condition on diabetes outcomes and psychosocial outcomes in adolescents with T1D.","['adolescents with T1D', 'Mothers of adolescents with type 1 diabetes (T1D) experience high rates of depressive symptoms and diabetes distress', 'adolescents', 'mothers of adolescents with type 1 diabetes']","['telephone and Facebook-delivered Communication & Coping intervention', 'adaptive coping strategies and positive parenting practices, to a diabetes education control condition', 'Communication and coping intervention']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],,0.0392277,"The randomized controlled trial compares the telephone and Facebook-delivered Communication & Coping intervention, which promotes the use of adaptive coping strategies and positive parenting practices, to a diabetes education control condition on diabetes outcomes and psychosocial outcomes in adolescents with T1D.","[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Jaser', 'Affiliation': 'Vanderbilt University Medical Center, USA. Electronic address: sarah.jaser@vumc.org.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Hamburger', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Pagoto', 'Affiliation': 'University of Connecticut, USA.'}, {'ForeName': 'Rodayne', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Meyn', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Abigail C', 'Initials': 'AC', 'LastName': 'Jones', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105844']
844,31500854,Randomized Crossover Trial of Phosphate-binding Medication on Serum Phosphate Levels in Patients With Aortic Stenosis.,"PURPOSE


Aortic stenosis is a common cause of valvular heart disease with no means of prevention. The recognized association between aortic stenosis and serum phosphate raises the possibility of preventing progression of the disorder by using phosphate-binding drugs, but there is uncertainty whether such treatment lowers serum phosphate levels in patients without diagnosed renal failure. This pilot study was conducted to answer this question in patients with aortic stenosis.
METHODS


A randomized, double-blind, crossover trial of the phosphate-binding drug sevelamer was conducted in 72 patients. Patients were prescribed sevelamer 0.8 g (low-dose), sevelamer 2.4 g (high-dose), and matching placebo, 3 times daily with food; each regimen lasted 6 weeks and was allocated at random. Serum phosphate levels were measured at the end of each treatment period, and within-person levels were compared.
FINDINGS


Sixty-one patients completed the 3 treatment periods. There was no significant difference in the mean end-treatment phosphate levels across all patients (3.38, 3.36, and 3.31 mg/dL with placebo, low-dose sevelamer, and high-dose sevelamer, respectively). Post hoc analysis showed a reduction in phosphate levels with increasing sevelamer dose in the highest baseline phosphate quartile group; a 0.3 mg/dL reduction (mean, 4.09 mg/dL with placebo, 3.95 mg/dL with low-dose sevelamer, and 3.79 mg/dL with high-dose sevelamer; P trend  = 0.027).
IMPLICATIONS


Sevelamer had no overall statistically significant effect in lowering serum phosphate levels, but a reduction was observed in patients with phosphate levels in the highest quartile group of the population distribution. This hypothesis-generating result requires confirmation in an independent study. If confirmed, a trial of sevelamer in preventing the progression of aortic stenosis may be justified in patients with high phosphate levels. ISRCTN Registry identifier: ISRCTN17365679.",2019,"IMPLICATIONS


Sevelamer had no overall statistically significant effect in lowering serum phosphate levels, but a reduction was observed in patients with phosphate levels in the highest quartile group of the population distribution.","['patients with aortic stenosis', '72 patients', 'Patients With Aortic Stenosis', 'patients with high phosphate levels', 'patients without diagnosed renal failure']","['sevelamer 0.8\xa0g (low-dose), sevelamer 2.4\xa0g (high-dose), and matching placebo', 'phosphate-binding drug sevelamer', 'placebo', 'Phosphate-binding Medication', 'sevelamer']","['Serum Phosphate Levels', 'phosphate levels', 'lowering serum phosphate levels', 'Serum phosphate levels', 'mean end-treatment phosphate levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0523826', 'cui_str': 'Phosphate measurement (procedure)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}]","[{'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523826', 'cui_str': 'Phosphate measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",61.0,0.0844807,"IMPLICATIONS


Sevelamer had no overall statistically significant effect in lowering serum phosphate levels, but a reduction was observed in patients with phosphate levels in the highest quartile group of the population distribution.","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Wald', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom. Electronic address: d.s.wald@qmul.ac.uk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chambers', 'Affiliation': 'Department of Cardiology, St Thomas Hospital, London, United Kingdom. Electronic address: john.chambers@gstt.nhs.uk.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Bestwick', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom. Electronic address: j.p.bestwick@qmul.ac.uk.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Wald', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom. Electronic address: n.j.wald@qmul.ac.uk.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.08.004']
845,31504596,Prostate-Specific Antigen Levels During Testosterone Treatment of Hypogonadal Older Men: Data from a Controlled Trial.,"CONTEXT


Prostate-specific antigen (PSA) changes during testosterone treatment of older hypogonadal men have not been rigorously evaluated.
DESIGN


Double-blinded, placebo-controlled trial.
SETTING


Twelve US academic medical centers.
PARTICIPANTS


Seven hundred ninety hypogonadal men ≥65 years of age with average testosterone levels ≤275 ng/dL. Men at high risk for prostate cancer were excluded.
INTERVENTIONS


Testosterone or placebo gel for 12 months.
MAIN OUTCOMES


Percentile changes in PSA during testosterone treatment of 12 months.
RESULTS


Testosterone treatment that increased testosterone levels from 232 ± 63 ng/dL to midnormal was associated with a small but substantially greater increase (P < 0.001) in PSA levels than placebo treatment. Serum PSA levels increased from 1.14 ± 0.86 ng/mL (mean ± SD) at baseline by 0.47 ± 1.1 ng/mL at 12 months in the testosterone group and from 1.25 ± 0.86 ng/mL by 0.06 ± 0.72 ng/mL in the placebo group. Five percent of men treated with testosterone had an increase ≥1.7 ng/mL and 2.5% of men had an increase of ≥3.4 ng/mL. A confirmed absolute PSA >4.0 ng/mL at 12 months was observed in 1.9% of men in the testosterone group and 0.3% in the placebo group. Four men were diagnosed with prostate cancer; two were Gleason 8.
CONCLUSIONS


When hypogonadal older men with normal baseline PSA are treated with testosterone, 5% had an increase in PSA ≥1.7 ng/mL, and 2.5% had an increase ≥3.4 ng/mL.",2019,Serum PSA levels increased from 1.14±0.86 ng/mL (mean ±SD) at baseline by 0.47±1.1 ng/mL at 12 months in the testosterone group and from 1.25±0.86 ng/mL by 0.06±0.72 ng/mL in the placebo group.,"['790 hypogonadal men ≥65 years with average testosterone levels ≤275 ng/dL. Men at high risk for prostate cancer were excluded', 'older hypogonadal men', 'Four men were diagnosed with prostate cancer', 'Twelve United States academic medical centers', 'Hypogonadal Older Men']","['placebo', 'testosterone', 'Testosterone', 'Testosterone or placebo gel']","['testosterone levels', 'PSA levels', 'Serum PSA levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",790.0,0.749418,Serum PSA levels increased from 1.14±0.86 ng/mL (mean ±SD) at baseline by 0.47±1.1 ng/mL at 12 months in the testosterone group and from 1.25±0.86 ng/mL by 0.06±0.72 ng/mL in the placebo group.,"[{'ForeName': 'Glenn R', 'Initials': 'GR', 'LastName': 'Cunningham', 'Affiliation': ""Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine, Baylor St. Luke's Medical Center, Houston, Texas.""}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Alvin M', 'Initials': 'AM', 'LastName': 'Matsumoto', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs Puget Sound Health Care System, Seattle, Washington.'}, {'ForeName': 'J Kellogg', 'Initials': 'JK', 'LastName': 'Parsons', 'Affiliation': 'Department of Urology, Moores Comprehensive Cancer Center, University of California San Diego, San Diego, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Preston', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Division of Geriatric Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'Division of Endocrinology, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Division of Endocrinology, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Kristine E', 'Initials': 'KE', 'LastName': 'Ensrud', 'Affiliation': 'Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology, School of Public Health at UAB, Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging & Geriatric Research, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Divisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Molitch', 'Affiliation': 'Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Cifelli', 'Affiliation': 'Center for Clinical Epidemiology & Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Diem', 'Affiliation': 'Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Alisa J', 'Initials': 'AJ', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Center for Clinical Epidemiology & Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00806']
846,30849721,"An inactive control of the 'Trier Social Stress Test' for Youth 10-17 years: Neuroendocrine, cardiac, and subjective responses.","The Trier Social Stress Test for children (TSST-C) adapted from TSST is one of the most commonly used laboratory paradigms for investigating the effects of stress on cognitive, affective and physiological responses in children and adolescents. Considering that laboratory procedures generate a significant amount of stress to children and adolescents, even in the absence of a stress paradigm, it is important to validate TSST-C against an inactive control condition in which the stress components were absent. Using a randomized design, we tested an inactive control condition, which replaced the TSST-C with a benign video clip (nature scenes viewed while standing), thus removing the stress associated components of the TSST-C. Eighty-eight youth between the ages of 10 and 17 years were randomly assigned to complete the TSST-C or the Inactive Control (IC). Subjective anxiety rating, salivary cortisol, systolic and diastolic blood pressure, and heart rate were collected at eight time points. Subjects in the Inactive Control condition showed no significant changes in blood pressure and heart rate, and decreased anxiety rating and salivary cortisol level throughout the study. Subjects in the stress condition (TSST-C) showed increased anxiety ratings, salivary cortisol, systolic and diastolic blood pressure, and heart rate immediately following TSST-C stress induction. Our findings validated that the TSST-C induced a systemic stress response, and that the Inactive Control can be a promising standardized control condition for the TSST-C and a tool for future psychobiological research. Our results also showed that anxiety reactivity decreased with age while HR reactivity increased with age. Cortisol reactivity did not fall in a linear relationship with age but rather via a quadratic curve, suggesting the mid-age adolescents had the highest cortisol responses to stress compared to their younger and older peers, potentially due to a dual factor of pubertal development and self-control and emotion regulation capacity.",2019,"Subjects in the Inactive Control condition showed no significant changes in blood pressure and heart rate, and decreased anxiety rating and salivary cortisol level throughout the study.","['TSST-C. Eighty-eight youth between the ages of 10 and 17 years', 'children and adolescents']","['TSST-C or the Inactive Control (IC', 'TSST-C with a benign video clip (nature scenes viewed while standing']","['HR reactivity', 'Cortisol reactivity', 'anxiety ratings, salivary cortisol, systolic and diastolic blood pressure, and heart rate immediately following TSST-C stress induction', 'anxiety reactivity', 'Subjective anxiety rating, salivary cortisol, systolic and diastolic blood pressure, and heart rate', 'blood pressure and heart rate, and decreased anxiety rating and salivary cortisol level']","[{'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",88.0,0.013836,"Subjects in the Inactive Control condition showed no significant changes in blood pressure and heart rate, and decreased anxiety rating and salivary cortisol level throughout the study.","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Yale Child Study Center, Yale School of Medicine, New Haven, CT, United States; Developmental Electrophysiology Laboratory, Yale Child Study Center, New Haven, CT, United States. Electronic address: jia.wu@yale.edu.'}, {'ForeName': 'Tammi-Marie', 'Initials': 'TM', 'LastName': 'Phillip', 'Affiliation': 'Yale Child Study Center, Yale School of Medicine, New Haven, CT, United States.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Doretto', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Sao Paulo, Brazil.'}, {'ForeName': 'Stefon', 'Initials': 'S', 'LastName': 'van Noordt', 'Affiliation': 'Yale Child Study Center, Yale School of Medicine, New Haven, CT, United States; Developmental Electrophysiology Laboratory, Yale Child Study Center, New Haven, CT, United States; Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Tara M', 'Initials': 'TM', 'LastName': 'Chaplin', 'Affiliation': 'Department of Psychology, George Mason University, Fairfax, VA, United States.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Hommer', 'Affiliation': 'Genetic Epidemiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Mayes', 'Affiliation': 'Yale Child Study Center, Yale School of Medicine, New Haven, CT, United States; Developmental Electrophysiology Laboratory, Yale Child Study Center, New Haven, CT, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Yale Child Study Center, Yale School of Medicine, New Haven, CT, United States; Program for Anxiety Disorders, Yale Child Study Center, New Haven, CT, United States; Developmental Electrophysiology Laboratory, Yale Child Study Center, New Haven, CT, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.02.027']
847,31047017,Natriuretic Response Is Highly Variable and Associated With 6-Month Survival: Insights From the ROSE-AHF Trial.,"OBJECTIVES


This study sought to describe sodium excretion in acute decompensated heart failure (ADHF) clearly and to evaluate the prognostic ability of urinary sodium and fluid-based metrics.
BACKGROUND


Sodium retention drives volume overload, with fluid retention largely a passive, secondary phenomenon. However, parameters (urine output, body weight) used to monitor therapy in ADHF measure fluid rather than sodium balance. Thus, the accuracy of fluid-based metrics hinges on the contested assumption that urinary sodium content is consistent.
METHODS


Patients enrolled in the ROSE-AHF (Renal Optimization Strategies Evaluation-Acute Heart Failure) trial with 24-h sodium excretion available were studied (n = 316). Patients received protocol-driven high-dose loop diuretic therapy.
RESULTS


Sodium excretion through the first 24 h was highly variable (range 0.12 to 19.8 g; median 3.63 g, interquartile range: 1.85 to 6.02 g) and was not correlated with diuretic agent dose (r = 0.06; p = 0.27). Greater sodium excretion was associated with reduced mortality in a univariate model (hazard ratio: 0.80 per doubling of sodium excretion; 95% confidence interval: 0.66 to 0.95; p = 0.01), whereas gross urine output (p = 0.43), net fluid balance (p = 0.87), and weight change (p = 0.11) were not. Sodium excretion of less than the prescribed dietary sodium intake (2 g), even in the setting of a negative net fluid balance, portended a worse prognosis (hazard ratio: 2.02; 95% confidence interval: 1.17 to 3.46; p = 0.01).
CONCLUSIONS


In patients hospitalized with ADHF who were receiving high-dose loop diuretic agents, sodium concentration and excretion were highly variable. Sodium excretion was strongly associated with 6-month mortality, whereas traditional fluid-based metrics were not. Poor sodium excretion, even in the context of fluid loss, portends a worse prognosis.",2019,"Greater sodium excretion was associated with reduced mortality in a univariate model (hazard ratio: 0.80 per doubling of sodium excretion; 95% confidence interval: 0.66 to 0.95; p = 0.01), whereas gross urine output (p = 0.43), net fluid balance (p = 0.87), and weight change (p = 0.11) were not.","['acute decompensated heart failure (ADHF', 'Patients enrolled in the ROSE-AHF (Renal Optimization Strategies Evaluation-Acute Heart Failure) trial with 24-h sodium excretion available were studied (n\xa0= 316', 'patients hospitalized with ADHF']",['protocol-driven high-dose loop diuretic therapy'],"['6-month mortality', 'net fluid balance', 'Natriuretic Response', 'gross urine output', 'Greater sodium excretion', 'Sodium excretion', 'weight change']","[{'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0450356', 'cui_str': '316'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0354100', 'cui_str': 'Loop Diuretics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",316.0,0.0919205,"Greater sodium excretion was associated with reduced mortality in a univariate model (hazard ratio: 0.80 per doubling of sodium excretion; 95% confidence interval: 0.66 to 0.95; p = 0.01), whereas gross urine output (p = 0.43), net fluid balance (p = 0.87), and weight change (p = 0.11) were not.","[{'ForeName': 'Daniel Z', 'Initials': 'DZ', 'LastName': 'Hodson', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Mahoney', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Parinita', 'Initials': 'P', 'LastName': 'Raghavendra', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Section of Nephrology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'F Perry', 'Initials': 'FP', 'LastName': 'Wilson', 'Affiliation': 'Section of Nephrology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Veena S', 'Initials': 'VS', 'LastName': 'Rao', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Mullens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost Limburg, Genk-Biomedical Research Institute, Faculty of Medicine and Life Sciences, Hasselt University Diepenbeek, Belgium.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Testani', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut. Electronic address: jeffrey.testani@yale.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.01.007']
848,31216226,Final Overall Survival of a Randomized Trial of Bevacizumab for Primary Treatment of Ovarian Cancer.,"PURPOSE


We report the final, protocol-specified analysis of overall survival (OS) in GOG-0218, a phase III, randomized trial of bevacizumab in women with newly diagnosed ovarian, fallopian tube, or primary peritoneal carcinoma.
METHODS


A total of 1,873 women with incompletely resected stage III to IV disease were randomly assigned 1:1:1 to six 21-day cycles of intravenous carboplatin (area under the concentration  v  time curve 6) and paclitaxel (175 mg/m 2 ) versus chemotherapy plus concurrent bevacizumab (15 mg/kg, cycles 2 to 6) versus chemotherapy plus concurrent and maintenance bevacizumab (cycles 2 to 22). Inclusion criteria included a Gynecologic Oncology Group performance status of 0 to 2 and no history of clinically significant vascular events or evidence of intestinal obstruction. OS was analyzed in the intention-to-treat population. A total of 1,195 serum and/or tumor specimens were sequenced for  BRCA1/2  and damaging mutations in homologous recombination repair (HRR) genes. Intratumoral microvessel density was studied using CD31 immunohistochemistry.
RESULTS


Median follow-up was 102.9 months. Relative to control (n = 625), for patients receiving bevacizumab-concurrent (n = 625), the hazard ratio (HR) of death was 1.06 (95% CI, 0.94 to 1.20); for bevacizumab-concurrent plus maintenance (n = 623), the HR was 0.96 (95% CI, 0.85 to 1.09). Disease-specific survival was not improved in any arm. No survival advantage was observed after censoring patients who received bevacizumab at crossover or as second line. Median OS for stage IV bevacizumab-concurrent plus maintenance was 42.8  v  32.6 months for stage IV control (HR, 0.75; 95% CI, 0.59 to 0.95). Relative to wild type, the HR for death for  BRCA1/2  mutated carcinomas was 0.62 (95% CI, 0.52 to 0.73), and for non- BRCA1/2  HRR, the HR was 0.65 (95% CI, 0.51 to 0.85).  BRCA1/2 , HRR, and CD31 were not predictive of bevacizumab activity.
CONCLUSION


No survival differences were observed for patients who received bevacizumab compared with chemotherapy alone. Testing for  BRCA1/2  mutations and homologous recombination deficiency is essential.",2019,Disease-specific survival was not improved in any arm.,"['women with newly diagnosed ovarian, fallopian tube, or primary peritoneal carcinoma', '1,873 women with incompletely resected stage III to IV disease', 'Ovarian Cancer']","['intravenous carboplatin (area under the concentration  v  time curve 6) and paclitaxel', 'bevacizumab', 'Bevacizumab', 'chemotherapy plus concurrent and maintenance bevacizumab', 'bevacizumab-concurrent', 'chemotherapy plus concurrent bevacizumab']","['hazard ratio (HR) of death', 'survival differences', 'Disease-specific survival', 'survival advantage', 'Median OS', 'Intratumoral microvessel density', 'BRCA1/2 , HRR, and CD31', 'vascular events or evidence of intestinal obstruction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0948303', 'cui_str': 'Peritoneal carcinoma'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2350570', 'cui_str': 'Microvessels'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0021843', 'cui_str': 'Intestinal Obstruction'}]",1873.0,0.353929,Disease-specific survival was not improved in any arm.,"[{'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Burger', 'Affiliation': 'University of Pennsylvania Abramson Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Enserro', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Barbara M', 'Initials': 'BM', 'LastName': 'Norquist', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Brady', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bookman', 'Affiliation': 'Permanente Medical Group, San Francisco, CA.'}, {'ForeName': 'Gini F', 'Initials': 'GF', 'LastName': 'Fleming', 'Affiliation': 'The University of Chicago, Chicago, IL.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Homesley', 'Affiliation': 'Indiana University Medical Center, Indianapolis, IN.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Fowler', 'Affiliation': 'The Ohio State University James Cancer Hospital, Columbus, OH.'}, {'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Greer', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Boente', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Sharon X', 'Initials': 'SX', 'LastName': 'Liang', 'Affiliation': 'Western Pennsylvania Hospital, Pittsburgh, PA.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bais', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Randall', 'Affiliation': 'University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Chan', 'Affiliation': 'California Pacific Medical Center Research Institute, San Francisco, CA.'}, {'ForeName': 'J Stuart', 'Initials': 'JS', 'LastName': 'Ferriss', 'Affiliation': 'Dell Seton Medical Center at The University of Texas, Austin, TX.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Herzog', 'Affiliation': 'University of Cincinnati Cancer Institute, Cincinnati, OH.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'DiSaia', 'Affiliation': 'University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'Larry J', 'Initials': 'LJ', 'LastName': 'Copeland', 'Affiliation': 'The Ohio State University James Cancer Hospital, Columbus, OH.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Birrer', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'University of Arizona and Creighton University, Phoenix, AZ.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01009']
849,32094154,Prospective community programme versus parent-driven care to prevent respiratory morbidity in children following hospitalisation with severe bronchiolitis or pneumonia.,"BACKGROUND


Hospitalisation with severe lower respiratory tract infection (LRTI) in early childhood is associated with ongoing respiratory symptoms and possible later development of bronchiectasis. We aimed to reduce this intermediate respiratory morbidity with a community intervention programme at time of discharge.
METHODS


This randomised, controlled, single-blind trial enrolled children aged <2 years hospitalised for severe LRTI to 'intervention' or 'control'. Intervention was three monthly community clinics treating wet cough with prolonged antibiotics referring non-responders. All other health issues were addressed, and health resilience behaviours were encouraged, with referrals for housing or smoking concerns. Controls followed the usual pathway of parent-initiated healthcare access. After 24 months, all children were assessed by a paediatrician blinded to randomisation for primary outcomes of wet cough, abnormal examination (crackles or clubbing) or chest X-ray Brasfield score ≤22.
FINDINGS


400 children (203 intervention, 197 control) were enrolled in 2011-2012; mean age 6.9 months, 230 boys, 87% Maori/Pasifika ethnicity and 83% from the most deprived quintile. Final assessment of 321/400 (80.3%) showed no differences in presence of wet cough (33.9% intervention, 36.5% controls, relative risk (RR) 0.93, 95% CI 0.69 to 1.25), abnormal examination (21.7% intervention, 23.9% controls, RR 0.92, 95% CI 0.61 to 1.38) or Brasfield score ≤22 (32.4% intervention, 37.9% control, RR 0.85, 95% CI 0.63 to 1.17). Twelve (all intervention) were diagnosed with bronchiectasis within this timeframe.
INTERPRETATION


We have identified children at high risk of ongoing respiratory disease following hospital admission with severe LRTI in whom this intervention programme did not change outcomes over 2 years.
TRIAL REGISTRATION NUMBER


ACTRN12610001095055.",2020,"Final assessment of 321/400 (80.3%) showed no differences in presence of wet cough (33.9% intervention, 36.5% controls, relative risk (RR) 0.93, 95% CI 0.69 to 1.25), abnormal examination (21.7% intervention, 23.9% controls, RR 0.92, 95% CI 0.61 to 1.38) or Brasfield score ≤22 (32.4% intervention, 37.9% control, RR 0.85, 95% CI 0.63 to 1.17).","['children following hospitalisation with severe bronchiolitis or pneumonia', '400 children (203 intervention, 197 control) were enrolled in 2011-2012; mean age 6.9 months, 230 boys, 87% Maori/Pasifika ethnicity and 83% from the most deprived quintile', ""enrolled children aged <2 years hospitalised for severe LRTI to 'intervention' or 'control""]",['Prospective community programme versus parent-drive care'],"['wet cough, abnormal examination (crackles or clubbing) or chest X-ray Brasfield score ≤22', 'respiratory morbidity', 'presence of wet cough', 'abnormal examination']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0024770', 'cui_str': 'Maori (ethnic group)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}]","[{'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0034642', 'cui_str': 'Rales'}, {'cui': 'C0039985', 'cui_str': 'Radiologic examination of chest'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]",400.0,0.203638,"Final assessment of 321/400 (80.3%) showed no differences in presence of wet cough (33.9% intervention, 36.5% controls, relative risk (RR) 0.93, 95% CI 0.69 to 1.25), abnormal examination (21.7% intervention, 23.9% controls, RR 0.92, 95% CI 0.61 to 1.38) or Brasfield score ≤22 (32.4% intervention, 37.9% control, RR 0.85, 95% CI 0.63 to 1.17).","[{'ForeName': 'Catherine Ann', 'Initials': 'CA', 'LastName': 'Byrnes', 'Affiliation': 'Department of Paediatrics, Child and Youth Health, The University of Auckland, Auckland, New Zealand c.byrnes@auckland.ac.nz.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Trenholme', 'Affiliation': 'Department of Paediatrics, Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Lawrence', 'Affiliation': 'Department of Paediatrics, KidzFirst Hospital Middlemore, Auckland, New Zealand.'}, {'ForeName': 'Harley', 'Initials': 'H', 'LastName': 'Aish', 'Affiliation': 'Otara Family and Christian Health Centre, Otara, Auckland, New Zealand.'}, {'ForeName': 'Julie Anne', 'Initials': 'JA', 'LastName': 'Higham', 'Affiliation': 'Hunter Corner Medical Centre, Papatoetoe, Auckland, New Zealand.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hoare', 'Affiliation': 'Greenstone Family Clinic, Manurewa, Auckland, New Zealand.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Elborough', 'Affiliation': 'Pukekohe Family Health Centre, Pukekohe, Auckland, New Zealand.'}, {'ForeName': 'Charissa', 'Initials': 'C', 'LastName': 'McBride', 'Affiliation': 'Department of Paediatrics, KidzFirst Hospital Middlemore, Auckland, New Zealand.'}, {'ForeName': 'Lyndsay', 'Initials': 'L', 'LastName': 'Le Comte', 'Affiliation': 'Counties Manukau District Health Board, Middlemore Clinical Trials Unit, Auckland, New Zealand.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McIntosh', 'Affiliation': 'Department of Paediatrics, KidzFirst Hospital Middlemore, Auckland, New Zealand.'}, {'ForeName': 'Florina', 'Initials': 'F', 'LastName': 'Chan Mow', 'Affiliation': 'Department of Paediatrics, KidzFirst Hospital Middlemore, Auckland, New Zealand.'}, {'ForeName': 'Mirjana', 'Initials': 'M', 'LastName': 'Jaksic', 'Affiliation': 'Department of Paediatrics, Child and Youth Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Metcalfe', 'Affiliation': ""Department of Radiology, Starship Children's Health, Auckland, New Zealand.""}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Coomarasamy', 'Affiliation': 'Research and Evaluation Office, Koawatea, Auckland, New Zealand.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Leung', 'Affiliation': 'Department of Health Economy, Wellington School of Medicine, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'Department of Paediatrics, KidzFirst Hospital Middlemore, Auckland, New Zealand.'}, {'ForeName': 'Teuila', 'Initials': 'T', 'LastName': 'Percival', 'Affiliation': 'Department of Paediatrics, KidzFirst Hospital Middlemore, Auckland, New Zealand.'}, {'ForeName': 'Henare', 'Initials': 'H', 'LastName': 'Mason', 'Affiliation': 'Koawatea, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Department of Population Health, The University of Auckland, Auckland, New Zealand.'}]",Thorax,['10.1136/thoraxjnl-2019-213142']
850,32222134,Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.,"BACKGROUND


The effect of vericiguat, a novel oral soluble guanylate cyclase stimulator, in patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received intravenous diuretic therapy is unclear.
METHODS


In this phase 3, randomized, double-blind, placebo-controlled trial, we assigned 5050 patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of less than 45% to receive vericiguat (target dose, 10 mg once daily) or placebo, in addition to guideline-based medical therapy. The primary outcome was a composite of death from cardiovascular causes or first hospitalization for heart failure.
RESULTS


Over a median of 10.8 months, a primary-outcome event occurred in 897 of 2526 patients (35.5%) in the vericiguat group and in 972 of 2524 patients (38.5%) in the placebo group (hazard ratio, 0.90; 95% confidence interval [CI], 0.82 to 0.98; P = 0.02). A total of 691 patients (27.4%) in the vericiguat group and 747 patients (29.6%) in the placebo group were hospitalized for heart failure (hazard ratio, 0.90; 95% CI, 0.81 to 1.00). Death from cardiovascular causes occurred in 414 patients (16.4%) in the vericiguat group and in 441 patients (17.5%) in the placebo group (hazard ratio, 0.93; 95% CI, 0.81 to 1.06). The composite of death from any cause or hospitalization for heart failure occurred in 957 patients (37.9%) in the vericiguat group and in 1032 patients (40.9%) in the placebo group (hazard ratio, 0.90; 95% CI, 0.83 to 0.98; P = 0.02). Symptomatic hypotension occurred in 9.1% of the patients in the vericiguat group and in 7.9% of the patients in the placebo group (P = 0.12), and syncope occurred in 4.0% of the patients in the vericiguat group and in 3.5% of the patients in the placebo group (P = 0.30).
CONCLUSIONS


Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo. (Funded by Merck Sharp & Dohme [a subsidiary of Merck] and Bayer; VICTORIA ClinicalTrials.gov number, NCT02861534.).",2020,"Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo.","['patients with high-risk heart failure', 'patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received', 'Patients with Heart Failure and Reduced Ejection Fraction', '5050 patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of less than 45% to receive']","['vericiguat (target dose, 10 mg once daily) or placebo, in addition to guideline-based medical therapy', 'placebo', 'intravenous diuretic therapy']","['syncope', 'Death from cardiovascular causes', 'Symptomatic hypotension', 'composite of death from cardiovascular causes or first hospitalization for heart failure', 'death from cardiovascular causes or hospitalization for heart failure', 'hospitalized for heart failure', 'composite of death from any cause or hospitalization for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0948575', 'cui_str': 'Diuretic therapy'}]","[{'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",5050.0,0.580875,"Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo.","[{'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Jia', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Koglin', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915928']
851,32222135,Rivaroxaban in Peripheral Artery Disease after Revascularization.,"BACKGROUND


Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events. The efficacy and safety of rivaroxaban in this context are uncertain.
METHODS


In a double-blind trial, patients with peripheral artery disease who had undergone revascularization were randomly assigned to receive rivaroxaban (2.5 mg twice daily) plus aspirin or placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes. The principal safety outcome was major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification; major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH) was a secondary safety outcome.
RESULTS


A total of 6564 patients underwent randomization; 3286 were assigned to the rivaroxaban group, and 3278 were assigned to the placebo group. The primary efficacy outcome occurred in 508 patients in the rivaroxaban group and in 584 in the placebo group; the Kaplan-Meier estimates of the incidence at 3 years were 17.3% and 19.9%, respectively (hazard ratio, 0.85, 95% confidence interval [CI], 0.76 to 0.96; P = 0.009). TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07). ISTH major bleeding occurred in 140 patients in the rivaroxaban group, as compared with 100 patients in the placebo group (5.94% and 4.06%; hazard ratio, 1.42; 95% CI, 1.10 to 1.84; P = 0.007).
CONCLUSIONS


In patients with peripheral artery disease who had undergone lower-extremity revascularization, rivaroxaban at a dose of 2.5 mg twice daily plus aspirin was associated with a significantly lower incidence of the composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes than aspirin alone. The incidence of TIMI major bleeding did not differ significantly between the groups. The incidence of ISTH major bleeding was significantly higher with rivaroxaban and aspirin than with aspirin alone. (Funded by Bayer and Janssen Pharmaceuticals; VOYAGER PAD ClinicalTrials.gov number, NCT02504216.).",2020,"TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07).","['patients with peripheral artery disease who had undergone lower-extremity revascularization', 'patients with peripheral artery disease who had undergone revascularization', '508 patients in the', 'Peripheral Artery Disease after Revascularization', 'Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events', '6564 patients underwent randomization; 3286 were assigned to the']","['aspirin', 'placebo', 'Rivaroxaban', 'aspirin or placebo plus aspirin', 'rivaroxaban']","['composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes', 'efficacy and safety', 'TIMI major bleeding', 'incidence of TIMI major bleeding', 'ISTH major bleeding', 'incidence of ISTH major bleeding', 'acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes', 'Kaplan-Meier estimates of the incidence', 'major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification; major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C4049535', 'cui_str': 'Acute limb ischaemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1720943', 'cui_str': 'Product-Limit Method'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",6564.0,0.574825,"TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07).","[{'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Rupert M', 'Initials': 'RM', 'LastName': 'Bauersachs', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Sonia S', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'E Sebastian', 'Initials': 'ES', 'LastName': 'Debus', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nehler', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Fanelli', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Warren H', 'Initials': 'WH', 'LastName': 'Capell', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Diao', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Jaeger', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Connie N', 'Initials': 'CN', 'LastName': 'Hess', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Akos F', 'Initials': 'AF', 'LastName': 'Pap', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kittelson', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Gudz', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Mátyás', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Dainis K', 'Initials': 'DK', 'LastName': 'Krievins', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muehlhofer', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Lloyd P', 'Initials': 'LP', 'LastName': 'Haskell', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}]",The New England journal of medicine,['10.1056/NEJMoa2000052']
852,32205572,Acute pain after serratus anterior plane or thoracic paravertebral blocks for video-assisted thoracoscopic surgery: A randomised trial.,"BACKGROUND


Serratus anterior and paravertebral blocks can both be used for video-assisted thoracic surgery. However, serratus anterior blocks are easier to perform, and possibly safer. We therefore tested the primary hypothesis that serratus anterior plane blocks and thoracic paravertebral blocks provide comparable analgesia for video-assisted thoracic surgery. Secondarily, we tested the hypothesis that both blocks lengthen the time to onset of surgical pain and reduce the need for rescue tramadol.
METHODS


Patients having video-assisted thoracic lobectomy or segmentectomy were randomly allocated to ultrasound-guided thoracic paravertebral blocks, n = 30; ultrasound-guided serratus anterior plane blocks, n = 30; or, general anaesthesia alone, n = 30. Visual analogue pain scores analogue pain scores at rest, during coughing and Prince-Henry pain scores were used to assess postoperative analgesia. Our primary analysis was noninferiority of serratus anterior blocks compared with paravertebral blocks.
RESULTS


Baseline characteristics were comparable among the three groups. Two hours after surgery, the mean difference in visual analogue pain scores between the serratus anterior and paravertebral blocks was 0.0 (96.8% CI -0.4 to 0.3) cm at rest, -0.2 (-0.8 to 0.4) cm during coughing and -0.1(-0.5 to 0.3) for Prince-Henry pain scores. After 24 h, the mean difference was 0.0 (-0.7 to 0.8) cm at rest, 0.1 (-0.8 to 0.9) cm during coughing and 0.1(-0.4 to 0.6) for Prince-Henry pain scores. All differences were significantly noninferior. Time to onset of pain after surgery was 19 ± 5 (SD) hours with serratus anterior blocks, 16 ± 5 h with paravertebral blocks and 12 ± 5 h with general anaesthesia. Anaesthesia with either block was associated with significantly less intra-operative propofol and sufentanil, reduced postoperative rescue analgesia (tramadol) and less postoperative nausea and vomiting compared with general anaesthesia alone. Patients with serratus anterior block had a significantly lower incidence of intra-operative hypotension and requirement for intra-operative vasopressor (3.4%), compared with general anaesthesia alone. Serratus anterior block took less time to perform than paravertebral block (5.1 ± 1.1 min versus 10.1 ± 2.9 min).
CONCLUSION


Serratus anterior plane blocks, which are easier and quicker than paravertebral blocks, provide comparable analgesia in patients having video-assisted thoracic surgery.
CLINICAL TRIAL NUMBER AND REGISTRY URL


ChiCTR1800017671; http://www.chictr.org.cn/hvshowproject.aspx?id=13510.",2020,"Anaesthesia with either block was associated with significantly less intra-operative propofol and sufentanil, reduced postoperative rescue analgesia (tramadol) and less postoperative nausea and vomiting compared with general anaesthesia alone.","['patients having video-assisted thoracic surgery', 'Patients having video-assisted thoracic lobectomy or segmentectomy']","['video-assisted thoracic surgery', 'serratus anterior plane or thoracic paravertebral blocks', 'ultrasound-guided thoracic paravertebral blocks, n\u200a=\u200a30; ultrasound-guided serratus anterior plane blocks, n\u200a=\u200a30; or, general anaesthesia alone, n\u200a=\u200a30', 'video-assisted thoracoscopic surgery', 'sufentanil']","['postoperative rescue analgesia (tramadol', 'visual analogue pain scores', 'Acute pain', 'Visual analogue visual analogue pain scores at rest, during coughing and Prince-Henry pain scores', 'postoperative nausea and vomiting', 'incidence of intra-operative hypotension and requirement for intra-operative vasopressor']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}]","[{'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0582517', 'cui_str': 'henry (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",,0.144153,"Anaesthesia with either block was associated with significantly less intra-operative propofol and sufentanil, reduced postoperative rescue analgesia (tramadol) and less postoperative nausea and vomiting compared with general anaesthesia alone.","[{'ForeName': 'Yuwei', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'From the Department of Anesthesiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China (YQ, JW, QH, YL, MX); Department of Outcomes Research, Anesthesiology Institute (YQ, DY, II, DIS); Outcomes Research Consortium (JW); Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio, USA (DY); Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey (II).'}, {'ForeName': 'Jingxiang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Yungang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Meiying', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Ince', 'Affiliation': ''}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001196']
853,32401380,"Comparison of therapeutic efficacy of topical treatment with phenytoin and fluocinolone on cutaneous lichen planus: A randomized, double-blind trial.",,2020,,['cutaneous lichen planus'],['phenytoin and fluocinolone'],[],"[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0023646', 'cui_str': 'Lichen planus'}]","[{'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0060507', 'cui_str': 'fluocinolone'}]",[],,0.633,,"[{'ForeName': 'Mozhdeh', 'Initials': 'M', 'LastName': 'Sepaskhah', 'Affiliation': 'Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Hemmatian Boroujeni', 'Affiliation': 'Department of Dermatology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Javaheri', 'Affiliation': 'Department of Dermatology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bagheri', 'Affiliation': 'Department of Biostatistics, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Dermatologic therapy,['10.1111/dth.13578']
854,32401385,Comparison of the efficiency of two different proton pump inhibitor formula in treatment of patients with atypical gastroesophageal reflux disease: a prospective randomized study.,"BACKGROUND AND AIM


The prospective, open-label, randomized study aims to compare the efficacy of lansoprazole, a fast orally disintegrating proton pump inhibitor (PPI), and dexlansoprazole, a dual delayed release PPI, in patients with atypical symptoms of gastroesophageal reflux disease (GERD).
METHODS


Patients with atypical GERD symptoms with a total reflux symptom index score > 10 were eligible for enrollment. From February 2018 to December 2019, 232 subjects were randomly assigned (1:1 ratio) to receive oral lansoprazole, Takepron OD 30 mg, once daily before breakfast or oral dexlansoprazole, Dexilant 60 mg, once daily before breakfast for 8 weeks. The primary end-point is to compare the symptoms response rate after an 8-week PPI therapy between the two groups.
RESULTS


There were 232 study subjects enrolling in this study. After the 8-week PPI therapy, dexlansoprazole-treated group had a significantly higher response rate than lansoprazole-treated group in cough (76.5% vs 38.0%) and globus (69.7% vs 30.8%) (P all < 0.05 by intention-to-treat). Multivariate logistic regression analysis showed that the use of dexlansoprazole, presence of dyslipidemia, and typical GERD symptoms (acid reflux and heartburn) were predictors for symptom response for cough; the use of dexlansoprazole and presence of erosive esophagitis were predictors for symptom response for globus (P all < 0.05). No predictor for therapy response to hoarseness was noted.
CONCLUSIONS


There is a higher response rate for cough and globus symptoms in patients with atypical GERD after the 8-week PPI therapy with dexlansoprazole rather than lansoprazole.",2020,There is a higher response rate for cough and globus symptoms in atypical GERD patients after a 8-week PPI therapy with dexlansoprazole rather than lansoprazole.,"['From Feb. 2018 to Dec. 2019, 232 subjects', 'atypical GERD patients', '232 study subjects enrolling in this study', 'patients with atypical symptoms of gastro-esophageal reflux disease (GERD', 'Patients with atypical GERD symptoms with a total Reflux Symptom Index (RSI) score >10 were eligible for enrollment']","['PPI formula', 'oral lansoprazole, Takepron® OD 30 mg, once daily before breakfast or oral dexlansoprazole, Dexilant®', 'lansoprazole']","['dyslipidemia and typical GERD symptoms (acid reflux and heartburn', 'symptoms response rate', 'response rate', 'response rate for cough and globus symptoms']","[{'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C1174766', 'cui_str': 'Takepron'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C1549040', 'cui_str': 'Before breakfast'}, {'cui': 'C2348248', 'cui_str': 'dexlansoprazole'}, {'cui': 'C2609580', 'cui_str': 'Dexilant'}]","[{'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0017650', 'cui_str': 'Feeling of lump in throat'}]",232.0,0.0220918,There is a higher response rate for cough and globus symptoms in atypical GERD patients after a 8-week PPI therapy with dexlansoprazole rather than lansoprazole.,"[{'ForeName': 'Xi-Hsuan', 'Initials': 'XH', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Jiing-Chyuan', 'Initials': 'JC', 'LastName': 'Luo', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Po-Hsiang', 'Initials': 'PH', 'LastName': 'Ting', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Tien-En', 'Initials': 'TE', 'LastName': 'Chang', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hsiang', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ming-Chih', 'Initials': 'MC', 'LastName': 'Hou', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Fa-Yauh', 'Initials': 'FY', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15093']
855,32404056,Effectiveness of concomitant use of green tea and polyethylene glycol in bowel preparation for colonoscopy: a randomized controlled study.,"BACKGROUND


Polyethylene glycol solution (PEG) is widely used for bowel preparation prior to colonoscopies. However, patients often exhibited adverse events as nausea, vomit and distention due to its uncomfortable tastes and potential side affects. This study aimed to evaluate the effectiveness and safety of concomitant use of green tea (GT) with PEG in bowel preparation prior to colonoscopy.
METHODS


This was a prospective, randomized controlled study. It was conducted at an outpatient setting of colorectal surgery in a tertiary hospital. Patients aged 18 through 80 who were scheduled to undergo colonoscopy between August 2015 and February 2016 were randomly assigned into two groups, admitting either 2 L-PEG solutions with 1 L GT liquids or 2 L-PEG solutions only for bowel preparation. Admitted doses of PEG solutions, taste evaluation, adverse reactions (nausea and vomiting, distention and abdominal pain) were investigated by questionnaires. The bowel cleanliness of each patient was evaluated according to the Aronchick indicators.
RESULTS


A total of 116 patients were enrolled in this study (PEG+GT 59, PEG 57). Full compliances were achieved in 93.2% patients of group PEG+GT and 59.6% of group PEG (p < 0.001). Mean Aronchick scale between two groups were 2.0 ± 0.9 versus 2.2 ± 0.7 respectively (PEG+GT vs PEG, p = 0.296). Rates of adverse events as nausea and vomiting, abdominal pain in bowel preparation were significantly different between two groups (55.9% vs 77.2%, p = 0.015 and 13.6% vs 33.3%, p = 0.012). Patients in group PEG+GT who have probabilities to receive repeating colonoscopy had a higher willingness to accept PEG+GT again for bowel preparation, compared with PEG group (94.9% vs 57.9%, p < 0.001).
CONCLUSIONS


Concomitant use of green tea and polyethylene glycol may effectively reduce incidence of adverse events, increase compliances, with comparable bowel cleanliness in bowel preparation.
TRIAL REGISTRATION


This trial was retrospectively registered on Feb 1st, 2019 (ChiCTR1900021178).",2020,"Patients in group PEG+GT who have probabilities to receive repeating colonoscopy had a higher willingness to accept PEG+GT again for bowel preparation, compared with PEG group (94.9% vs 57.9%, p < 0.001).
","['colonoscopy', 'Patients aged 18 through 80 who were scheduled to undergo colonoscopy between August 2015 and February 2016', '116 patients were enrolled in this study (PEG+GT 59, PEG 57']","['Polyethylene glycol solution (PEG', 'admitting either 2\u2009L-PEG solutions with 1\u2009L GT liquids or 2\u2009L-PEG solutions only for bowel preparation', 'green tea (GT) with PEG', 'green tea and polyethylene glycol']","['Full compliances', 'Mean Aronchick scale', 'nausea, vomit and distention', 'Rates of adverse events as nausea and vomiting, abdominal pain in bowel preparation', 'taste evaluation, adverse reactions (nausea and vomiting, distention and abdominal pain']","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",116.0,0.083535,"Patients in group PEG+GT who have probabilities to receive repeating colonoscopy had a higher willingness to accept PEG+GT again for bowel preparation, compared with PEG group (94.9% vs 57.9%, p < 0.001).
","[{'ForeName': 'Zong', 'Initials': 'Z', 'LastName': 'Hao', 'Affiliation': ""Department of General Surgery, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, 200240, China.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Gong', 'Affiliation': ""Department of General Surgery, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, 200240, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': ""Department of Endoscopic Center, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, 200240, China.""}, {'ForeName': 'Huipeng', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, 200240, China.""}, {'ForeName': 'Shaowen', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': ""Department of General Surgery, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, 200240, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, 200240, China.""}, {'ForeName': 'Yuankun', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""Department of General Surgery, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, 200240, China. 18918168583@163.com.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Colorectal Surgery, Peking University International Hospital, Beijing, 102206, China. chenjun@pkuih.edu.cn.'}]",BMC gastroenterology,['10.1186/s12876-020-01220-3']
856,32404059,Effectiveness of a community program for older adults with type 2 diabetes and multimorbidity: a pragmatic randomized controlled trial.,"BACKGROUND


Type II diabetes mellitus (T2DM) affects upwards of 25% of Canadian older adults and is associated with high comorbidity and burden. Studies show that lifestyle factors and self-management are associated with improved health outcomes, but many studies lack rigour or exclude older adults, particularly those with multimorbidity. More evidence is needed on the effectiveness of community-based self-management programs in older adults with T2DM and multimorbidity. The study purpose is to evaluate the effect of a community-based intervention versus usual care on physical functioning, mental health, depressive symptoms, anxiety, self-efficacy, self-management, and healthcare costs in older adults with T2DM and 2 or more comorbidities.
METHODS


Community-living older adults with T2DM and two or more chronic conditions were recruited from three Primary Care Networks (PCNs) in Alberta, Canada. Participants were randomly allocated to the intervention or control group in this pragmatic randomized controlled trial comparing the intervention to usual care. The intervention involved up to three in-home visits, a monthly group wellness program, monthly case conferencing, and care coordination. The primary outcome was physical functioning. Secondary outcomes included mental functioning, anxiety, depressive symptoms, self-efficacy, self-management, and the cost of healthcare service use. Intention-to-treat analysis was performed using ANCOVA modeling.
RESULTS


Of 132 enrolled participants (70-Intervention, 62-Control), 42% were 75 years or older, 55% were female, and over 75% had at least six chronic conditions (in addition to T2DM). No significant group differences were seen for the baseline to six-month change in physical functioning (mean difference: -0.74; 95% CI: - 3.22, 1.74; p-value: 0.56), mental functioning (mean difference: 1.24; 95% CI: - 1.12, 3.60; p-value: 0.30), or other secondary outcomes..
CONCLUSION


No significant group differences were seen for the primary outcome, physical functioning (PCS). Program implementation, baseline differences between study arms and chronic disease management services that are part of usual care may have contributed to the modest study results. Fruitful areas for future research include capturing clinical outcome measures and exploring the impact of varying the type and intensity of key intervention components such as exercise and diet.
TRIAL REGISTRATION


NCT02158741 Date of registration: June 9, 2014.",2020,"No significant group differences were seen for the baseline to six-month change in physical functioning (mean difference: -0.74; 95% CI: - 3.22, 1.74; p-value: 0.56), mental functioning (mean difference: 1.24; 95% CI: - 1.12, 3.60; p-value: 0.30), or other secondary outcomes..
CONCLUSION


","['older adults with T2DM and multimorbidity', 'older adults with T2DM and 2 or more comorbidities', 'Type II diabetes mellitus (T2DM) affects upwards of 25% of Canadian older adults', 'Community-living older adults with T2DM and two or more chronic conditions were recruited from three Primary Care Networks (PCNs) in Alberta, Canada', '132 enrolled participants (70-Intervention, 62-Control', 'older adults with type 2 diabetes and multimorbidity', ' 42% were 75\u2009years or older, 55% were female, and over 75% had at least six chronic conditions (in addition to T2DM']","['community program', 'community-based intervention versus usual care']","['mental functioning, anxiety, depressive symptoms, self-efficacy, self-management, and the cost of healthcare service use', 'physical functioning, mental health, depressive symptoms, anxiety, self-efficacy, self-management, and healthcare costs', 'physical functioning (PCS', 'mental functioning', 'physical functioning']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0557143', 'cui_str': 'Lives in a community'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0557829', 'cui_str': 'Healthcare services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}]",132.0,0.11465,"No significant group differences were seen for the baseline to six-month change in physical functioning (mean difference: -0.74; 95% CI: - 3.22, 1.74; p-value: 0.56), mental functioning (mean difference: 1.24; 95% CI: - 1.12, 3.60; p-value: 0.30), or other secondary outcomes..
CONCLUSION


","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Miklavcic', 'Affiliation': 'Schmid College of Science and Technology, Chapman University, Orange, California, 92866, USA.'}, {'ForeName': 'Kimberly D', 'Initials': 'KD', 'LastName': 'Fraser', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, T6G2R3, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ploeg', 'Affiliation': 'School of Nursing, and Scientific Director, Aging, Community and Health Research Unit, School of Nursing McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada. ploegj@mcmaster.ca.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Markle-Reid', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Fisher', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Amiram', 'Initials': 'A', 'LastName': 'Gafni', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact; and Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, L8S 4K1, Canada.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Griffith', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Hirst', 'Affiliation': 'Faculty of Nursing, University of Calgary, Calgary, Alberta, T2N 1N4, Canada.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'Sadowski', 'Affiliation': 'Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, 3-171 Edmonton Clinic Health Academy, Edmonton, Alberta, T6G 1C9, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, L8S 4K1, Canada.'}, {'ForeName': 'Jean A C', 'Initials': 'JAC', 'LastName': 'Triscott', 'Affiliation': 'Care of the Elderly Division, Glenrose Rehabilitation Hospital, Rm 1244 10230-111 Avenue, Edmonton, Alberta, T5G 0B7, Canada.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Upshur', 'Affiliation': 'Division of Clinical Public Health, Dalla Lana School of Public Health, University of Toronto, Room 678 155 College Street, Toronto, Ontario, M5T 3M7, Canada.'}]",BMC geriatrics,['10.1186/s12877-020-01557-0']
857,32404076,The effects of gamification on antimicrobial resistance knowledge and its relationship to dentistry in Saudi Arabia: a randomized controlled trial.,"BACKGROUND


Antimicrobial resistance (AMR) has reached alarming levels and is considered to be a worldwide public health problem. One of the most significant factors contributing to the spread of AMR is the lack of proper knowledge about the use of antibiotics, which are being used more frequently in dentistry. Recent studies have found that gamification shows promising results for helping the average person improve their knowledge about health and may also be used to boost knowledge about AMR among the public. This study aimed to assess the effects of gamification on AMR awareness, using a board game to promote knowledge about AMR among the public in Saudi Arabia.
METHODS


Using a single-blinded parallel group randomized controlled trial design, 94 volunteers were recruited and randomized into two groups. The study group received information about AMR by playing a board game, while the control group received the same information given in a conventional lecture. The participants were evaluated three times: (T1) before the intervention, (T2) immediately after the intervention, and (T3) one month after the intervention for follow-up to evaluate their retention of the information.
RESULTS


Results showed that there were significant improvements (p <  0.05) in knowledge scores for T2 and T3 in comparison to the T1 baseline scores in both groups. However, the knowledge scores also relapsed significantly from T2 to T3 in both groups. Nevertheless, the difference in knowledge score T1 to T3 was significantly higher in the study group in comparison to the control group, and the participants had higher mean scores to use the game as health promotion method.
CONCLUSIONS


Gamification using a board game can significantly improve AMR knowledge, with better retention than conventional lecture. It is a promising method for boosting public knowledge about AMR and its relationship to dentistry.
TRIAL REGISTRATION


ISRCTN registry: ISRCTN15884410 (retrospectively registered 26-October-2019).",2020,"RESULTS


Results showed that there were significant improvements (p <  0.05) in knowledge scores for T2 and T3 in comparison to the T1 baseline scores in both groups.","['Saudi Arabia', '94 volunteers']","['information about AMR by playing a board game, while the control group received the same information given in a conventional lecture']","['knowledge score T1 to T3', 'knowledge scores', 'AMR knowledge']","[{'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",94.0,0.0755879,"RESULTS


Results showed that there were significant improvements (p <  0.05) in knowledge scores for T2 and T3 in comparison to the T1 baseline scores in both groups.","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Aboalshamat', 'Affiliation': 'Dental Public Health Division, Preventative Dentistry Department, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia. ktaboalshamat@uqu.edu.sa.'}, {'ForeName': 'Amjad', 'Initials': 'A', 'LastName': 'Khayat', 'Affiliation': 'College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Ragheb', 'Initials': 'R', 'LastName': 'Halwani', 'Affiliation': 'College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Bitan', 'Affiliation': 'College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Ryyan', 'Initials': 'R', 'LastName': 'Alansari', 'Affiliation': 'College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}]",BMC public health,['10.1186/s12889-020-08806-2']
858,32404088,"The effect of health education on knowledge and behavior toward respiratory infectious diseases among students in Gansu, China: a quasi-natural experiment.","BACKGROUND


The respiratory infectious diseases (RID) threaten the health and life quality of school students. However, previous related studies were insufficient in research design and method applied. This study aimed to evaluate the effect of health education on the knowledge and behavior of students toward RID through difference-in-difference (DID) analysis in Gansu, China.
METHODS


In 2015-2016, a one-year health education program in Gansu, China was conducted. The intervention group contained 1064 students before and 1001 students after the health education (2015 and 2016, respectively). The control group contained 1018 and 1001 students, respectively. The health education, including playing promotional cartoons, developing lectures, giving out handbook copies and making hand copy and blackboard newspapers, and publicity columns on RID, were conducted monthly from 2015 to 2016 in intervention group. The data were collected before and after the health education program with a questionnaire on the students' knowledge and preventive behaviors regarding RID. The × 2  and t tests were performed to compare the accuracy rate and scores for RID knowledge and behavior of the two groups. DID estimation was conducted to evaluate the effect of health education on RID knowledge and behavior while controlling the non- equilibrium variables.
RESULTS


After the health education program, the accuracy rate and scores of most items in the intervention group were significantly higher than those in the control group (P < 0.05) except for item k9 ""What methods can prevent flu?"". The DID results wherein the demographics- age, nationality, and household register were controlled showed that health education significantly improved the accuracy rate of RID knowledge by 5.2-63.9% for most items, although the accuracy rates of items k2 ""What's the transmission way of the mumps?"" and k9 were significantly decreased by 36.8 and 12.0%. The health education significantly improved the score of knowledge by 155.2% (P < 0.001) and the accuracy rate of all items of RID behavior by 2.9-51.5% except for item b3 ""If you have phlegm, how do you usually deal with it?"". In addition, the health education also significantly improved the score of behavior toward RID of the sampled students by 138.2% (P < 0.001).
CONCLUSION


The results of this study show that health education seemed to increase the RID knowledge and behavior of students. It is recommended that the health education should be enhanced and popularized in schools of China, and RID transmission routes and prevention methods should attract more attention.",2020,"The health education significantly improved the score of knowledge by 155.2% (P < 0.001) and the accuracy rate of all items of RID behavior by 2.9-51.5% except for item b3 ""If you have phlegm, how do you usually deal with it?"".","['students in Gansu, China', '1064 students before and 1001 students after the health education (2015 and 2016, respectively', 'In 2015-2016, a one-year health education program in Gansu, China was conducted', 'school students']",['health education'],"['score of knowledge', 'accuracy rate and scores of most items', 'score of behavior toward RID', 'accuracy rate of all items of RID behavior', 'accuracy rate and scores for RID knowledge and behavior', 'accuracy rate of RID knowledge', 'knowledge and behavior toward respiratory infectious diseases', 'RID knowledge and behavior of students']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",,0.0225614,"The health education significantly improved the score of knowledge by 155.2% (P < 0.001) and the accuracy rate of all items of RID behavior by 2.9-51.5% except for item b3 ""If you have phlegm, how do you usually deal with it?"".","[{'ForeName': 'Manli', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'China Center for Special Economic Zone Research, Shenzhen University, Shenzhen, 518060, China.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': ""Administration Office, Shenzhen People's Hospital, Second Clinical Medical College of Jinan University, First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, 518020, China. fanghq@szhospital.com.""}]",BMC public health,['10.1186/s12889-020-08813-3']
859,32404599,Effect of blood insulin level on postprandial hypotension in elderly people.,"OBJECTIVES


The aim of the study is to discuss the effect of postprandial insulin level on blood pressure in elderly patients by comparing the blood pressure, blood glucose, and insulin levels between patients with postprandial hypotension (PPH) and non-PPH over 80 years old during fasting and within 2 h after meal, and observing the changes of parameters in patients with PPH before and after treatment with acarbose.
METHODS AND MATERIALS


Twenty-five PPH patients and 27 non-PPH patients were selected. The blood pressure, blood glucose, and insulin levels during fasting and within 2 h after meal were monitored. Patients with PPH were treated with acarbose. All parameters were checked one week later.
RESULTS


(1) Preprandial blood pressure in PPH group was significantly higher than that in non-PPH group (152.00 ± 15.62 mmHg vs. 136.40 ± 14.12 mmHg, P < 0.05). (2) The maximum decrease of postprandial systolic blood pressure (SBP) in PPH group was significantly increased compared with that of the control group (32.20 ± 13.19 mmHg vs. 9.67 ± 8.38 mmHg, P < 0.05). The maximum increases of postprandial blood glucose and insulin levels were significantly higher in PPH group than in the control group (P < 0.05). (3) After acarbose treatment, the decrease of postprandial SBP in PPH group was significantly reduced compared with that before treatment (22.67 ± 6.98 mmHg vs. 32.60 ± 9.55 mmHg, P < 0.05); the increase of postprandial blood glucose was also significantly reduced in PPH group (2.37 ± 1.63 mmol/L vs. 3.39 ± 1.62 mmol/L, P < 0.05); the increase of postprandial insulin level was reduced significantly in PPH group (12.09 ± 3.96 mU/L vs. 22.33 ± 1.78 mU/L, P < 0.05). (4) There was no correlation between the maximum decrease of postprandial SBP and the maximum increase of blood glucose (r = -0.008, P = 0.961), but the maximum decrease of postprandial SBP was positively correlated with the maximum increase of insulin (r = 0.381, P = 0.032).
CONCLUSION


PPH tends to occur in elderly people with elevated basal blood pressure before meal. PPH is associated with an abnormal increase of postprandial insulin secretion. Reducing the increase of postprandial insulin is one of the mechanisms of acarbose in the treatment of PPH.",2020,The maximum increases of postprandial blood glucose and insulin levels were significantly higher in PPH group than in the control group (P < 0.05).,"['elderly people with elevated basal blood pressure before meal', 'patients with postprandial hypotension (PPH) and non-PPH over 80\u2009years old during fasting and within 2\u2009h after meal, and observing the changes of parameters in patients with PPH before and after treatment with', 'Twenty-five PPH patients and 27 non-PPH patients were selected', 'Patients with PPH', 'elderly people', 'elderly patients']","['blood insulin level', 'PPH', 'postprandial insulin level', 'acarbose']","['postprandial insulin', 'postprandial hypotension', 'blood pressure', 'postprandial insulin level', 'blood glucose', 'Preprandial blood pressure', 'postprandial systolic blood pressure (SBP', 'postprandial blood glucose', 'postprandial blood glucose and insulin levels', 'postprandial SBP', 'blood pressure, blood glucose, and insulin levels', 'postprandial insulin secretion']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0853230', 'cui_str': 'Blood insulin'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}]",25.0,0.0150893,The maximum increases of postprandial blood glucose and insulin levels were significantly higher in PPH group than in the control group (P < 0.05).,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'The Six Department of Cardiac Surgery, Beijing An Zhen Hospital, Capital Medical University.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qiao', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Yunyun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Kejing', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000450']
860,32406112,Randomised clinical trial: linaclotide vs placebo-a study of bi-directional gut and brain axis.,"BACKGROUND


Linaclotide, a guanylate cyclase C agonist relieves irritable bowel syndrome with predominant constipation (IBS-C) symptoms, but how it improves pain in humans is unknown.
AIMS


To investigate the effects of linaclotide and placebo on the afferent and efferent gut-brain-gut signalling in IBS-C patients, in a randomised clinical trial.
METHODS


Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations. Rectal sensations were examined by balloon distention. Assessments included abdominal pain, bowel symptoms and quality of life (QOL) scores. Primary outcomes were latencies of recto-cortical and cortico-rectal evoked potentials.
RESULTS


Thirty-nine patients participated; 26 received linaclotide and 13 received placebo. Rectal cortical evoked potentials latencies (milliseconds) were significantly prolonged with linaclotide compared to baseline (P1:Δ 19 ± 6, P < 0.005; N1:Δ 20 ± 7, P < 0.02) but not with placebo (P1:Δ 3 ± 5; N1:Δ 4.7 ± 5,P = 0.3) or between groups. The efferent cortico-anorectal and spino-anorectal latencies were unchanged. The maximum tolerable rectal volume (cc) increased significantly with linaclotide compared to baseline (P < 0.001) and placebo (Δ 29 ± 10 vs 4 ± 20, (P < 0.03). Abdominal pain decreased (P < 0.001) with linaclotide but not between groups. Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo. There was no difference in overall responders between linaclotide and placebo (54% vs 23%, P = 0.13).
CONCLUSIONS


Linaclotide prolongs afferent gut-brain signalling from baseline but both afferent and efferent signalling were unaffected compared to placebo. Linaclotide significantly improves rectal hypersensitivity, IBS-C symptoms and QOL compared to placebo. These mechanisms may explain the effects of linaclotide on pain relief in IBS-C patients. ClinicalTrials.Gov: Registered at Clinical trials.gov no NCT02078323.",2020,"Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo.","['Thirty-nine patients participated; 26 received', 'IBS-C patients', 'Patients with IBS-C (Rome III) and rectal hypersensitivity']","['linaclotide', 'linaclotide (290\xa0µg) or placebo for 10\xa0weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations', 'Linaclotide', 'linaclotide vs placebo', 'linaclotide and placebo', 'placebo']","['abdominal pain, bowel symptoms and quality of life (QOL) scores', 'pain relief', 'overall responders', 'rectal hypersensitivity, IBS-C symptoms and QOL', 'Rectal sensations', 'latencies of recto-cortical and cortico-rectal evoked potentials', 'IBS-QOL scores', 'efferent cortico-anorectal and spino-anorectal latencies', 'Abdominal pain', 'Rectal cortical evoked potentials latencies (milliseconds', 'Complete spontaneous bowel movement frequency', 'maximum tolerable rectal volume (cc']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C2000261', 'cui_str': 'linaclotide'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0232717', 'cui_str': 'Rectal sensation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0205116', 'cui_str': 'Efferent'}, {'cui': 'C0439223', 'cui_str': 'ms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",39.0,0.636366,"Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo.","[{'ForeName': 'Satish S C', 'Initials': 'SSC', 'LastName': 'Rao', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Kulthep', 'Initials': 'K', 'LastName': 'Rattanakovit', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Tanisa', 'Initials': 'T', 'LastName': 'Patcharatrakul', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parr', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Ayyala', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Amol', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Division of Neurogastroenterology/Motility, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15772']
861,32220517,The BlastGen study: a randomized controlled trial of blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor.,"RESEARCH QUESTION


Does Embryogen®/BlastGen™ culture medium improve live birth rates compared with standard culture medium for women undergoing IVF and intracytoplasmic sperm injection (ICSI) with poor prognosis.
DESIGN


Randomized clinical trial. A total of 100 couples undergoing IVF/ICSI were randomly allocated to having their inseminated oocytes incubated in either Embryogen®/BlastGen™ sequential culture media or standard Cleavage/Blastocyst sequential culture media for 5 days (ClinicalTrials.gov Identifier: NCT02305420).
RESULTS


No statistically significant difference in live birth rate was found between the control group and the Embryogen®/BlastGen™ group (17 [34%] versus 11 [22%], respectively) (OR 0.55; 95% CI 0.22 to 1.32; P = 0.18). After adjustment for maternal age, body mass index and fertilization procedure, the blastulation rate reduced (40.6 ± 26.5 versus 24.6 ± 26.7; RR 0.70, CI 0.52 to 0.95; P < 0.05), and grade of the embryo transferred (OR 0.35, CI 0.16 to 0.77; P < 0.01) when Embryogen®/BlastGen™ medium was used.
CONCLUSION


A significant reduction in day-5 embryo outcome parameters was found using Embryogen®/BlastGen™ compared with standard medium, and insufficient evidence of a difference in pregnancy outcomes. Taking into consideration the small samples size, study limitations and strict inclusion criteria of this single-centre study, further research is needed to determine the efficacy of Embryogen®/BlastGen™ medium in couples undergoing IVF/ICSI.",2020,"A significant reduction in day-5 embryo outcome parameters was found using Embryogen®/BlastGen™ compared with standard medium, and insufficient evidence of a difference in pregnancy outcomes.","['couples undergoing IVF/ICSI', '100 couples undergoing IVF/ICSI', 'women undergoing IVF and intracytoplasmic sperm injection (ICSI) with poor prognosis']","['Embryogen®/BlastGen', 'having their inseminated oocytes incubated in either Embryogen®/BlastGen™ sequential culture media or standard Cleavage/Blastocyst sequential culture media', 'blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor']","['blastulation rate', 'grade of the embryo transferred', 'live birth rates', 'live birth rate']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}]","[{'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0010454', 'cui_str': 'Culture Media'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}]",100.0,0.22946,"A significant reduction in day-5 embryo outcome parameters was found using Embryogen®/BlastGen™ compared with standard medium, and insufficient evidence of a difference in pregnancy outcomes.","[{'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Rose', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia. Electronic address: ryan.rose@adelaide.edu.au.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Barry', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}, {'ForeName': 'Emma V', 'Initials': 'EV', 'LastName': 'Dunstan', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia.'}, {'ForeName': 'Siu Man', 'Initials': 'SM', 'LastName': 'Yuen', 'Affiliation': 'Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}, {'ForeName': 'Lyndal P', 'Initials': 'LP', 'LastName': 'Cameron', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Knight', 'Affiliation': 'School of Public Health, Robinson Research Institute, AHMS Building, The University of Adelaide, North Terrace, Adelaide5005 SA, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}, {'ForeName': 'M Louise', 'Initials': 'ML', 'LastName': 'Hull', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.011']
862,30705390,Screening and brief intervention for obesity in primary care: cost-effectiveness analysis in the BWeL trial.,"BACKGROUND


The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years.
METHODS


Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years.
RESULTS


Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice.
CONCLUSIONS


A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m 2  reduces healthcare costs and improves health more than advising weight loss.",2019,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","['Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity', 'patients with a BMI of at least 30\u2009kg/m 2  reduces healthcare costs and improves health more than advising weight loss', '1882 consecutively attending primary care patients who were obese and participants']","['physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice']","['disease incidence, quality of life, and healthcare costs', 'cumulative incidence of weight-related disease', 'weight loss', 'health service costs']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0034380'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1882.0,0.159942,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Retat', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pimpin', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Abbygail', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tearne', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Christian-Brown', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Ashby Road, Loughborough, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lycett', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Priory Street, Coventry, CV1 5FB, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. paul.aveyard@phc.ox.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-018-0295-7']
863,31704437,"Protocol for a systematically-developed, phase I/II, single-blind randomized controlled trial of treadmill walking exercise training effects on cognition and brain function in persons with multiple sclerosis.","Slowed cognitive processing speed (CPS) is a common and debilitating consequence of multiple sclerosis (MS) that is notoriously difficult to treat. As such, we undertook a systematic line of research that indicated that supervised, progressive treadmill walking exercise (TMWX) training might improve CPS and brain functioning among fully-ambulatory persons with MS. The current study will be the first adequately-powered, single-blind randomized controlled trial (RCT) that examines the efficacy of 12-weeks of TMWX training compared with an active control condition on CPS, thalamocortical brain connectivity (based on resting-state fMRI), and exploratory functional outcomes in 88 fully-ambulatory persons with MS who present with slowed CPS. The intervention condition involves supervised, progressive TMWX training 3 times/week over 12-weeks; this initially involves 15-min of light-to-moderate intensity TMWX that progresses up to 40-min of vigorous intensity TMWX. The active control condition involves supervised, minimal intensity, stretching-and-resistance exercise that will be delivered on the same frequency as the intervention condition. The primary study outcomes involve Symbol Digit Modalities Test performance (i.e., CPS) and fMRI-based measures of thalamocortical resting-state functional connectivity. Exploratory study outcomes involve measures of community participation, activities of daily living, quality of life, and functional mobility. All study outcomes will be administered before and after the 12-week study period by treatment-blinded assessors. If successful, the current study will provide the first Class I evidence for the effects of TMWX training as an approach for improving CPS and its neural correlate, and possibly mitigating the impact of slowed CPS on functional outcomes in MS.",2019,"The intervention condition involves supervised, progressive TMWX training 3 times/week over 12-weeks; this initially involves 15-min of light-to-moderate intensity TMWX that progresses up to 40-min of vigorous intensity TMWX.","['persons with multiple sclerosis', '88 fully-ambulatory persons with MS who present with slowed CPS', 'fully-ambulatory persons with MS']","['supervised, progressive treadmill walking exercise (TMWX) training', 'Slowed cognitive processing speed (CPS', 'treadmill walking exercise training', 'TMWX training']","['Symbol Digit Modalities Test performance (i.e., CPS) and fMRI-based measures of thalamocortical resting-state functional connectivity', 'community participation, activities of daily living, quality of life, and functional mobility', 'CPS and brain functioning', 'cognition and brain function']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0451522', 'cui_str': 'Symbol Digit Modalities Test'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0009476', 'cui_str': 'Community Participation'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0034380'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'function'}]",88.0,0.0221623,"The intervention condition involves supervised, progressive TMWX training 3 times/week over 12-weeks; this initially involves 15-min of light-to-moderate intensity TMWX that progresses up to 40-min of vigorous intensity TMWX.","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Sandroff', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: sandroff@uab.edu.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Diggs', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Marcas M', 'Initials': 'MM', 'LastName': 'Bamman', 'Affiliation': 'Departments of Cell, Developmental, & Integrative Biology, University of Alabama at Birmingham, Birmingham, AL, USA; Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jessica F', 'Initials': 'JF', 'LastName': 'Baird', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'C Danielle', 'Initials': 'CD', 'LastName': 'Jones', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Rinker', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Glenn R', 'Initials': 'GR', 'LastName': 'Wylie', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105878']
864,27034455,The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment.,"BACKGROUND


Challenges to effective pharmacologic management of symptomatic diabetic peripheral neuropathy include the limited effectiveness of available medicines, frequent side effects, and the need for ongoing symptom assessment and treatment titration for maximal effectiveness. We present here the rationale and implementation challenges of the Diabetes Telephone Study, a randomized trial designed to improve medication treatment, titration, and quality of life among patients with symptomatic diabetic peripheral neuropathy.
METHODS


We implemented a pragmatic cluster randomized controlled trial to test the effectiveness of an automated interactive voice response tool designed to provide physicians with real-time patient-reported data about responses to newly prescribed diabetic peripheral neuropathy medicines. A total of 1834 primary care physicians treating patients in the diabetes registry at Kaiser Permanente Northern California were randomized into the intervention or control arm. In September 2014, we began identification and recruitment of patients assigned to physicians in the intervention group who receive three brief interactive calls every 2 months after a medication is prescribed to alleviate diabetic peripheral neuropathy symptoms. These calls provide patients with the opportunity to report on symptoms, side effects, self-titration of medication dose and overall satisfaction with treatment. We plan to compare changes in self-reported quality of life between the intervention group and patients in the control group who receive three non-interactive automated educational phone calls.
RESULTS


Successful implementation of this clinical trial required robust stakeholder engagement to help tailor the intervention and to address pragmatic concerns such as provider time constraints. As of 27 October 2015, we had screened 2078 patients, 1447 of whom were eligible for participation. We consented and enrolled 1206 or 83% of those eligible. Among those enrolled, 53% are women and the mean age is 67 (standard deviation = 12) years. The racial ethnic make-up is 56% White, 8% Asian, 13% Black or African American, and 19% Hispanic or Latino.
CONCLUSION


Innovative strategies are needed to guide improvements in healthcare delivery for patients with symptomatic diabetic peripheral neuropathy. This trial aims to assess whether real-time collection and clinical feedback of patient treatment experiences can reduce patient symptom burden. Implementation of a clinical trial closely involving clinical care required researchers to partner with clinicians. If successful, this intervention provides a critical information feedback loop that would optimize diabetic peripheral neuropathy medication titration through widely available interactive voice response technology.",2016,We implemented a pragmatic cluster randomized controlled trial to test the effectiveness of an automated interactive voice response tool designed to provide physicians with real-time patient-reported data about responses to newly prescribed diabetic peripheral neuropathy medicines.,"['27 October 2015, we had screened 2078 patients, 1447 of whom were eligible for participation', '1834 primary care physicians treating patients in the diabetes registry at Kaiser Permanente Northern California', 'Among those enrolled, 53% are women and the mean age is 67 (standard deviation\u2009=\u200912)\u2009years', 'patients with symptomatic diabetic peripheral neuropathy']","['automated interactive voice response', 'three non-interactive automated educational phone calls']",['quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",[{'cui': 'C0034380'}],2078.0,0.0805978,We implemented a pragmatic cluster randomized controlled trial to test the effectiveness of an automated interactive voice response tool designed to provide physicians with real-time patient-reported data about responses to newly prescribed diabetic peripheral neuropathy medicines.,"[{'ForeName': 'Alyce S', 'Initials': 'AS', 'LastName': 'Adams', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, CA, USA Alyce.S.Adams@kp.org.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bayliss', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Altschuler', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dyer', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Neugebauer', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Jaffe', 'Affiliation': 'South San Francisco Medical Center, Kaiser Permanente, South San Francisco, CA, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': 'Oakland Medical Center, Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Oakland Medical Center, Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Grant', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774516631530']
865,32065623,"Clinical Effects of the Self-administered Subcutaneous Complement Inhibitor Zilucoplan in Patients With Moderate to Severe Generalized Myasthenia Gravis: Results of a Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial.","Importance


Many patients with generalized myasthenia gravis (gMG) have substantial clinical disability, persistent disease burden, and adverse effects attributable to chronic immunosuppression. Therefore, there is a significant need for targeted, well-tolerated therapies with the potential to improve disease control and enhance quality of life.
Objective


To evaluate the clinical effects of zilucoplan, a subcutaneously (SC) self-administered macrocyclic peptide inhibitor of complement component 5, in a broad population of patients with moderate to severe gMG.
Design, Setting, and Participants


This randomized, double-blind, placebo-controlled phase 2 clinical trial at 25 study sites across North America recruited participants between December 2017 and August 2018. Fifty-seven patients were screened, of whom 12 did not meet inclusion criteria and 1 was lost to follow-up after randomization but before receiving study drug, resulting in a total of 44 acetylcholine receptor autoantibody (AChR-Ab)-positive patients with gMG with baseline Quantitative Myasthenia Gravis (QMG) scores of at least 12, regardless of treatment history.
Interventions


Patients were randomized 1:1:1 to a daily SC self-injection of placebo, 0.1-mg/kg zilucoplan, or 0.3-mg/kg zilucoplan for 12 weeks.
Main Outcomes and Measures


The primary and key secondary end points were the change from baseline to week 12 in QMG and MG Activities of Daily Living scores, respectively. Significance testing was prespecified at a 1-sided α of .10. Safety and tolerability were also assessed.
Results


The study of 44 patients was well balanced across the 3 treatment arms with respect to key demographic and disease-specific variables. The mean age of patients across all 3 treatment groups ranged from 45.5 to 54.6 years and most patients were white (average proportions across 3 treatment groups: 78.6%-86.7%). Clinically meaningful and statistically significant improvements in primary and key secondary efficacy end points were observed. Zilucoplan at a dose of 0.3 mg/kg SC daily resulted in a mean reduction from baseline of 6.0 points in the QMG score (placebo-corrected change, -2.8; P = .05) and 3.4 points in the MG Activities of Daily Living score (placebo-corrected change, -2.3; P = .04). Clinically meaningful and statistically significant improvements were also observed in other secondary end points, the MG Composite and MG Quality-of-Life scores. Outcomes for the 0.1-mg/kg SC daily dose were also statistically significant but slower in onset and less pronounced than with the 0.3-mg/kg dose. Rescue therapy (intravenous immunoglobulin or plasma exchange) was required in 3 of 15, 1 of 15, and 0 of 14 participants in the placebo, 0.1-mg/kg zilucoplan, and 0.3-mg/kg zilucoplan arms, respectively. Zilucoplan was observed to have a favorable safety and tolerability profile.
Conclusions and Relevance


Zilucoplan yielded rapid, meaningful, and sustained improvements over 12 weeks in a broad population of patients with moderate to severe AChR-Ab-positive gMG. Near-complete complement inhibition appeared superior to submaximal inhibition. The observed safety and tolerability profile of zilucoplan was favorable.
Trial Registration


ClinicalTrials.gov Identifier: NCT03315130.",2020,"Clinically meaningful and statistically significant improvements were also observed in other secondary end points, the MG Composite and MG Quality-of-Life scores.","['44 patients was well balanced across the 3 treatment arms with respect to key demographic and disease-specific variables', 'Patients With Moderate to Severe Generalized Myasthenia Gravis', 'patients with generalized myasthenia gravis (gMG', '25 study sites across North America recruited participants between December 2017 and August 2018', 'Fifty-seven patients were screened, of whom 12 did not meet inclusion criteria and 1 was lost to follow-up after randomization but before receiving study drug, resulting in a total of 44 acetylcholine receptor autoantibody (AChR-Ab)-positive patients with gMG with baseline Quantitative Myasthenia Gravis (QMG) scores of at least 12, regardless of treatment history', 'patients with moderate to severe gMG']","['zilucoplan', 'placebo', 'zilucoplan, a subcutaneously (SC) self-administered macrocyclic peptide inhibitor', 'Self-administered Subcutaneous Complement Inhibitor Zilucoplan', 'daily SC self-injection of placebo, 0.1-mg/kg zilucoplan, or 0.3-mg/kg zilucoplan', 'Rescue therapy (intravenous immunoglobulin or plasma exchange', 'placebo, 0.1-mg/kg zilucoplan, and 0.3-mg/kg zilucoplan', 'Zilucoplan', 'Placebo']","['QMG and MG Activities of Daily Living scores', 'favorable safety and tolerability profile', 'MG Composite and MG Quality-of-Life scores', 'Daily Living score', 'QMG score', 'Safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0751339', 'cui_str': 'Myasthenia Gravis, Generalized'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0765796', 'cui_str': 'GMG'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034792', 'cui_str': 'Receptors, Acetylcholine'}, {'cui': 'C0004358', 'cui_str': 'Autoantibodies'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1564892', 'cui_str': 'Complement Inactivating Agents'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0032113', 'cui_str': 'Plasma Exchange'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",57.0,0.514858,"Clinically meaningful and statistically significant improvements were also observed in other secondary end points, the MG Composite and MG Quality-of-Life scores.","[{'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Howard', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Nowak', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Gil I', 'Initials': 'GI', 'LastName': 'Wolfe', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Miriam L', 'Initials': 'ML', 'LastName': 'Freimer', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Tuan H', 'Initials': 'TH', 'LastName': 'Vu', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Hinton', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Benatar', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Petra W', 'Initials': 'PW', 'LastName': 'Duda', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'MacDougall', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Farzaneh-Far', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Barohn', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Dimachkie', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Mamatha', 'Initials': 'M', 'LastName': 'Pasnoor', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Farmakidis', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Colgan', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Benatar', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Tulio', 'Initials': 'T', 'LastName': 'Bertorini', 'Affiliation': 'Wesley Neurology Clinic, Cordova, Tennessee.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Pillai', 'Affiliation': 'Wesley Neurology Clinic, Cordova, Tennessee.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Henegar', 'Affiliation': 'Wesley Neurology Clinic, Cordova, Tennessee.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bromberg', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Gibson', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Janecki', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Freimer', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Bakri', 'Initials': 'B', 'LastName': 'Elsheikh', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Matisak', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Genge', 'Affiliation': 'Montreal Neurological Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Guidon', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'David', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'Ali A', 'Initials': 'AA', 'LastName': 'Habib', 'Affiliation': 'University of California, Irvine, Orange.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Mathew', 'Affiliation': 'University of California, Irvine, Orange.'}, {'ForeName': 'Tahseen', 'Initials': 'T', 'LastName': 'Mozaffar', 'Affiliation': 'University of California, Irvine, Orange.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Hinton', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hewitt', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Barnett', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sullivan', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Ho', 'Affiliation': 'Lahey Hospital, Burlington, Massachusetts.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Howard', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Traub', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Chopra', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Radwa', 'Initials': 'R', 'LastName': 'Aly', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Bayat', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abu-Rub', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Shaida', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'University of Texas Southwestern, Dallas, Irving.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Lange', 'Affiliation': 'Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Shara', 'Initials': 'S', 'LastName': 'Holzberg', 'Affiliation': 'Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Bhupendra', 'Initials': 'B', 'LastName': 'Khatri', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Lindman', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Tayo', 'Initials': 'T', 'LastName': 'Olapo', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Sershon', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Lisak', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Bernitsas', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Jia', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Malik', 'Affiliation': 'Rush University, Chicago, Illinois.'}, {'ForeName': 'Tiffany D', 'Initials': 'TD', 'LastName': 'Lewis-Collins', 'Affiliation': 'Rush University, Chicago, Illinois.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nicolle', 'Affiliation': 'London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Nowak', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Roy', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Nye', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pulley', 'Affiliation': 'University of Florida, Jacksonville.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'University of Florida, Jacksonville.'}, {'ForeName': 'Yasmeen', 'Initials': 'Y', 'LastName': 'Shabbir', 'Affiliation': 'University of Florida, Jacksonville.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Sachdev', 'Affiliation': 'Michigan State University, East Lansing.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Patterson', 'Affiliation': 'Michigan State University, East Lansing.'}, {'ForeName': 'Zaeem', 'Initials': 'Z', 'LastName': 'Siddiqi', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sivak', 'Affiliation': 'Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bratton', 'Affiliation': 'Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Small', 'Affiliation': 'Allegheny Neurological Associates, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Anem', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'Allegheny Neurological Associates, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fetter', 'Affiliation': 'Allegheny Neurological Associates, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Tuan', 'Initials': 'T', 'LastName': 'Vu', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lam', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Harvey', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'Gil I', 'Initials': 'GI', 'LastName': 'Wolfe', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Silvestri', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Patrick', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Zakalik', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Petra W', 'Initials': 'PW', 'LastName': 'Duda', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacDougall', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Farzaneh-Far', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Pontius', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hoarty', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}]",JAMA neurology,['10.1001/jamaneurol.2019.5125']
866,31633643,Improved Reduction of the Tibiofibular Syndesmosis With TightRope Compared With Screw Fixation: Results of a Randomized Controlled Study.,"OBJECTIVE


To compare the rate of malreduction after high fibular fractures associated with syndesmosis injury treated with open reduction and internal fixation, with either 2 screws or 1 knotless TightRope device.
DESIGN


Prospective randomized controlled multicenter trial.
SETTING


Eleven academic and community hospitals including Level 1 and Level 2 trauma centers across Canada.
PATIENTS/PARTICIPANTS


One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability after malleolar bony fixation were followed for 12 months after treatment.
METHODS


Open reduction of the syndesmosis was performed in all cases. Fixation was randomized to either TightRope (1 knotless TightRope, group T) or screw fixation (two 3.5-mm cortical positional screws placed across 3 cortices, group S). Surgical techniques and rehabilitation were standardized. All surgeons were trained or experienced in the use of the TightRope device. Follow-up was performed at 2 and 6 weeks, 3, 6, and 12 months.
MAIN OUTCOME MEASURE


Rate of malreduction based on bilateral ankle computed tomography scan results at 3 months after fixation. Secondary outcome measures included adverse events, reoperation, and validated functional outcomes including the EQ-5D, the Olerud-Molander Ankle Score, the Foot and Ankle Disability Index, and the Work Productivity Activity Impairment Questionnaire. The estimated sample size required to detect a difference in reduction rate was 72 patients, but the estimated sample size required to detect a difference in functional outcome scores was 240 patients, suggesting the study was adequately powered for radiographic results only.
RESULTS


Overall, the rate of malreduction using screw fixation was 39% compared with 15% using TightRope fixation (P = 0.028, χ). Analysis of computed tomography results was performed using a 2-mm translation or 10-degree rotation threshold for malreduction and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, and mid); medial compression; and rotation (fibular and articular). Patients in group T had greater anterior translation (5.4 ± 1.8 mm) compared with the contralateral limb (4.3 ± 1.3 mm, P < 0.01) or group S (4.6 ± 1.5 mm, P = 0.05). Group T syndesmoses also had greater diastasis compared with control limb (4.1 ± 1.3 vs. 3.3 ± 1.4 mm, P < 0.01) and less fibular medialization compared with group S (1.04 ± 1.8 vs. 0.3 ± 1.8 mm, P = 0.05). Functional outcome measures demonstrated significant improvements over time, but no differences between fixation groups. Foot and Ankle Disability Index scores at each time interval were 44 ± 22 (T) versus 45 ± 24 (S) (6 weeks), 76 ± 14 versus 73 ± 17 (3 months), 89 ± 10 versus 86 ± 13 (6 months), and 93 ± 9 versus 90 ± 14 (12 months) (all P > 0.2). The reoperation rate was higher in the screw group compared with TightRope (30% vs. 4%, P = 0.02) with the difference driven by the rate of implant removal.
CONCLUSIONS


Based on our results, the TightRope device seems to compare favorably with two, 3.5-mm, 3-cortex screw fixation for syndesmosis injuries.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,"Patients in group T had greater anterior translation (5.4 ± 1.8 mm) compared with the contralateral limb (4.3 ± 1.3 mm, P < 0.01) or group S (4.6 ± 1.5 mm, P = 0.05).","['Eleven academic and community hospitals including Level 1 and Level 2 trauma centers across Canada', 'One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability after malleolar bony fixation were followed for 12 months after treatment']","['TightRope (1 knotless TightRope, group T) or screw fixation', 'Screw Fixation', '3-cortex screw fixation', 'syndesmosis injury treated with open reduction and internal fixation, with either 2 screws or 1 knotless TightRope device', 'TightRope']","['rate of implant removal', 'Foot and Ankle Disability Index scores', '2-mm translation or 10-degree rotation threshold for malreduction and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, and mid); medial compression; and rotation (fibular and articular', 'greater anterior translation', 'adverse events, reoperation, and validated functional outcomes including the EQ-5D, the Olerud-Molander Ankle Score, the Foot and Ankle Disability Index, and the Work Productivity Activity Impairment Questionnaire', 'reoperation rate', 'fibular medialization', 'rate of malreduction using screw fixation', 'Rate of malreduction based on bilateral ankle computed tomography scan results']","[{'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0456948', 'cui_str': 'Level 2 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0036679', 'cui_str': 'Separation (morphologic abnormality)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0443157', 'cui_str': 'Bony (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0561946', 'cui_str': 'Removal of implant (procedure)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",240.0,0.152368,"Patients in group T had greater anterior translation (5.4 ± 1.8 mm) compared with the contralateral limb (4.3 ± 1.3 mm, P < 0.01) or group S (4.6 ± 1.5 mm, P = 0.05).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'Department of Orthopedic Surgery, London Health Sciences Centre, Victoria Hospital, London, ON Canada.'}, {'ForeName': 'Prism', 'Initials': 'P', 'LastName': 'Schneider', 'Affiliation': 'Department of Orthopedic Surgery, Foothills Medical Centre, Calgary, AB, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'Department of Orthopedic Surgery, London Health Sciences Centre, Victoria Hospital, London, ON Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tieszer', 'Affiliation': 'Department of Orthopedic Surgery, London Health Sciences Centre, Victoria Hospital, London, ON Canada.'}, {'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Lawendy', 'Affiliation': 'Department of Orthopedic Surgery, London Health Sciences Centre, Victoria Hospital, London, ON Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001559']
867,32217809,Pasireotide for acromegaly: long-term outcomes from an extension to the Phase III PAOLA study.,"Objective


In the Phase III PAOLA study (clinicaltrials.gov: NCT01137682), enrolled patients had uncontrolled acromegaly despite ≥6 months of octreotide/lanreotide treatment before study start. More patients achieved biochemical control with long-acting pasireotide versus continued treatment with octreotide/lanreotide (active control) at month 6. The current work assessed the extent of comorbidities at baseline and outcomes during a long-term extension.
Design/methods


Patients receiving pasireotide 40 or 60 mg at core study end could continue on the same dose in an extension phase if biochemically controlled or receive pasireotide 60 mg if uncontrolled. Uncontrolled patients on active control were switched to pasireotide 40 mg, with the dose increased at week 16 of the extension if still uncontrolled (crossover group). Efficacy and safety are reported to 304 weeks (~5.8 years) for patients randomized to pasireotide (core + extension), and 268 weeks for patients in the crossover group (extension only).
Results


Almost half (49.5%; 98/198) of patients had ≥3 comorbidities at core baseline. During the extension, 173 patients received pasireotide. Pasireotide effectively and consistently reduced GH and IGF-I levels for up to 5.8 years' treatment; 37.0% of patients achieved GH <1.0 µg/L and normal IGF-I at some point during the core or extension. Improvements were observed in key symptoms. The long-term safety profile was similar to that in the core study; 23/173 patients discontinued treatment because of adverse events.
Conclusions


In this patient population with a high burden of comorbid illness, pasireotide was well tolerated and efficacious, providing prolonged maintenance of biochemical control and improving symptoms.",2020,More patients achieved biochemical control with long-acting pasireotide versus continued treatment with octreotide/lanreotide (active control) at month 6.,"['173 patients received', 'enrolled patients had uncontrolled acromegaly despite ≥6 months of', 'treatment before study start', 'Patients receiving pasireotide 40 or 60 mg at core study end could continue on the same dose in an extension phase if biochemically controlled, or receive']","['pasireotide 60 mg if uncontrolled', 'pasireotide', 'octreotide/lanreotide']","['tolerated and efficacious', 'GH and IGF-I levels', 'normal IGF', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001206', 'cui_str': 'Somatotropin Hypersecretion Syndrome (Acromegaly)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C4033783', 'cui_str': 'pasireotide 60 MG [Signifor]'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.141322,More patients achieved biochemical control with long-acting pasireotide versus continued treatment with octreotide/lanreotide (active control) at month 6.,"[{'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Colao', 'Affiliation': 'Università Federico II di Napoli, Naples, Italy.'}, {'ForeName': 'Marcello D', 'Initials': 'MD', 'LastName': 'Bronstein', 'Affiliation': 'University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Brue', 'Affiliation': 'Aix-Marseille Université, Institut National de la Santé et de la Recherche Médicale INSERM U1251, Marseille Medical Genetics and Assistance Publique Hôpitaux de Marseille (APHM), Hôpital de la Conception, Marseille, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'De Marinis', 'Affiliation': 'Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fleseriu', 'Affiliation': 'Northwest Pituitary Center, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Mirtha', 'Initials': 'M', 'LastName': 'Guitelman', 'Affiliation': 'Endocrinology Division, Carlos G Durand Hospital, Buenos Aires, Argentina.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Raverot', 'Affiliation': 'Groupement Hospitalier Est, Hospices Civils de Lyon and Lyon 1 University, Lyon, France.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Shimon', 'Affiliation': 'Rabin Medical Center and Sackler School of Medicine, Tel-Aviv University, Petah-Tiqva, Israel.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Fleck', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Pritam', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Novartis Healthcare Private Limited, Hyderabad, India.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Pedroncelli', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Mônica R', 'Initials': 'MR', 'LastName': 'Gadelha', 'Affiliation': 'Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.'}]",European journal of endocrinology,['10.1530/EJE-19-0762']
868,32217876,Neurally Adjusted Ventilatory Assist versus Pressure Support Ventilation in Difficult Weaning: A Randomized Trial.,"BACKGROUND


Difficult weaning frequently develops in ventilated patients and is associated with poor outcome. In neurally adjusted ventilatory assist, the ventilator is controlled by diaphragm electrical activity, which has been shown to improve patient-ventilator interaction. The objective of this study was to compare neurally adjusted ventilatory assist and pressure support ventilation in patients difficult to wean from mechanical ventilation.
METHODS


In this nonblinded randomized clinical trial, difficult-to-wean patients (n = 99) were randomly assigned to neurally adjusted ventilatory assist or pressure support ventilation mode. The primary outcome was the duration of weaning. Secondary outcomes included the proportion of successful weaning, patient-ventilator asynchrony, ventilator-free days, and mortality. Weaning duration was calculated as 28 days for patients under mechanical ventilation at day 28 or deceased before day 28 without successful weaning.
RESULTS


Weaning duration in all patients was statistically significant shorter in the neurally adjusted ventilatory assist group (n = 47) compared with the pressure support ventilation group (n = 52; 3.0 [1.2 to 8.0] days vs. 7.4 [2.0 to 28.0], mean difference: -5.5 [95% CI, -9.2 to -1.4], P = 0.039). Post hoc sensitivity analysis also showed that the neurally adjusted ventilatory assist group had shorter weaning duration (hazard ratio, 0.58; 95% CI, 0.34 to 0.98). The proportion of patients with successful weaning from invasive mechanical ventilation was higher in neurally adjusted ventilatory assist (33 of 47 patients, 70%) compared with pressure support ventilation (25 of 52 patients, 48%; respiratory rate for neurally adjusted ventilatory assist: 1.46 [95% CI, 1.04 to 2.05], P = 0.026). The number of ventilator-free days at days 14 and 28 was statistically significantly higher in neurally adjusted ventilatory assist compared with pressure support ventilation. Neurally adjusted ventilatory assist improved patient ventilator interaction. Mortality and length of stay in the intensive care unit and in the hospital were similar among groups.
CONCLUSIONS


In patients difficult to wean, neurally adjusted ventilatory assist decreased the duration of weaning and increased ventilator-free days.",2020,Weaning duration in all patients was statistically significant shorter in the neurally adjusted ventilatory assist group (n = 47) compared with the pressure support ventilation group (n = 52,"['patients difficult to wean from mechanical ventilation', 'wean patients (n = 99', 'ventilated patients', 'Difficult Weaning']","['neurally adjusted ventilatory assist and pressure support ventilation', 'Neurally Adjusted Ventilatory Assist versus Pressure Support Ventilation', 'neurally adjusted ventilatory assist or pressure support ventilation mode', 'pressure support ventilation']","['shorter weaning duration', 'proportion of successful weaning, patient-ventilator asynchrony, ventilator-free days, and mortality', 'proportion of patients with successful weaning from invasive mechanical ventilation', 'Mortality and length of stay', 'patient ventilator interaction', 'respiratory rate', 'number of ventilator-free days', 'Weaning duration', 'duration of weaning', 'pressure support ventilation', 'duration of weaning and increased ventilator-free days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",99.0,0.15027,Weaning duration in all patients was statistically significant shorter in the neurally adjusted ventilatory assist group (n = 47) compared with the pressure support ventilation group (n = 52,"[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'From the Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, Jiangsu, China (L.L., X.X., Q.S., Y. Yu., F.X., J.X., Y. Yang, H.Q.) the Department of Intensive Care, Amsterdam University Medical Center, Amsterdam, The Netherlands (L.H.).'}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Feiping', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Heunks', 'Affiliation': ''}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003207']
869,31575423,Comparison of Frequency of Atherosclerotic Cardiovascular Disease Events Among Primary and Secondary Prevention Subgroups of the Systolic Blood Pressure Intervention Trial.,"The Pooled Cohort Equation (PCE) predicts 10-year risk of first-time atherosclerotic cardiovascular disease (ASCVD) events and was incorporated in analyses of a primary and secondary prevention population in the Systolic Blood Pressure Intervention Trial (SPRINT). Whether PCE enhances risk prediction among secondary prevention populations is unknown. We sought to compare ASCVD events by level of PCE-predicted risk among primary and secondary prevention SPRINT populations. SPRINT randomized adults with hypertension and ≥1 CVD risk factor or previous CVD events to systolic blood pressure control targeting <120 mm Hg or 135 to 139 mm Hg. We calculated the hazard ratio (HR) of ASCVD events among secondary versus primary (reference) prevention subgroups overall and by predicted 10-year ASCVD risk categories (<10%, 10% to <20%, 20% to <30%, and ≥30%) and within risk subgroups, comparing to the lowest risk category. Among 8,151 participants, 16% with previous CVD, mean age was 66 years and 35% were women. The HR for ASCVD events overall was 2.51 (1.96, 3.20). HR was 2.97 (1.47, 5.99) among <10% 10-year risk and 2.23 (1.38, 3.59) among ≥30% risk. Within subgroups comparing ≥30% to <10% risk (reference) categories, the HR was 2.85 (1.76, 4.63) for primary and 2.14 (1.07, 4.30) for the secondary prevention. In conclusion, history of previous events was a potent risk factor for subsequent ASCVD events. The PCE does not enhance risk prediction among secondary prevention populations and may differentially underestimate risk in secondary prevention populations with lowest predicted risk.",2019,The PCE does not enhance risk prediction among secondary prevention populations and may differentially underestimate risk in secondary prevention populations with lowest predicted risk.,"['Primary and Secondary Prevention Subgroups of the Systolic Blood Pressure Intervention Trial', '8,151 participants, 16% with previous CVD, mean age was 66 years and 35% were women', 'SPRINT randomized adults with hypertension and ≥1 CVD risk factor or previous CVD events to systolic blood pressure control targeting <120 mm Hg or 135 to 139 mm Hg']",['PCE'],"['hazard ratio (HR) of ASCVD events', '10-year ASCVD risk categories']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}]","[{'cui': 'C1588205', 'cui_str': 'PCE'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0342558,The PCE does not enhance risk prediction among secondary prevention populations and may differentially underestimate risk in secondary prevention populations with lowest predicted risk.,"[{'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Plante', 'Affiliation': 'Department of Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont. Electronic address: Timothy.Plante@uvm.edu.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'Zakai', 'Affiliation': 'Department of Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont; Department Pathology and Laboratory Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Tracy', 'Affiliation': 'Department Pathology and Laboratory Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Cushman', 'Affiliation': 'Department of Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont; Department Pathology and Laboratory Medicine, Larner College of Medicine at the University of Vermont, Burlington, Vermont.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.08.028']
870,31652073,Effects of Hormone Therapy on Heart Fat and Coronary Artery Calcification Progression: Secondary Analysis From the KEEPS Trial.,"Background Heart fats (epicardial and paracardial adipose tissue [PAT]) are greater after menopause. Endogenous estrogen may regulate these fat depots. We evaluated the differential effects of hormone therapy formulations on heart fat accumulations and their associations with coronary artery calcification (CAC) progression in recently menopausal women from KEEPS (Kronos Early Estrogen Prevention Study). Methods and Results KEEPS was a multicenter, randomized, placebo-controlled trial of the effects of 0.45 mg/d oral conjugated equine estrogens and 50 µg/d transdermal 17β-estradiol, compared with placebo, on 48-month progression of subclinical atherosclerosis among 727 early menopausal women. CAC progression was defined if baseline CAC score was 0 and 48-month CAC score was >0 or if baseline CAC score was >0 and <100 and annualized change in CAC score was ≥10. Of 727 KEEPS participants, 474 (mean age: 52.7 [SD: 2.6]; 78.1% white) had computed tomography-based heart fat and CAC measures at both baseline and 48 months. Compared with women on placebo, women on oral conjugated equine estrogens were less likely to have any increase in epicardial adipose tissue (odds ratio for oral conjugated equine estrogens versus placebo: 0.62 [95% CI, 0.40-0.97];  P =0.03). PAT did not change in any group. Changes in epicardial adipose tissue and PAT did not differ by treatment group. CAC increased in 14% of participants. The assigned treatment modified the association between PAT changes and CAC progression ( P =0.02) such that PAT increases were associated with CAC increases only in the transdermal 17β-estradiol group. Conclusions In recently menopausal women, oral conjugated equine estrogens may slow epicardial adipose tissue accumulation, whereas transdermal 17β-estradiol may increase progression of CAC associated with PAT accumulation. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00154180.",2019,"Compared with women on placebo, women on oral conjugated equine estrogens were less likely to have any increase in epicardial adipose tissue (odds ratio for oral conjugated equine estrogens versus placebo: 0.62 [95% CI, 0.40-0.97];  P =0.03).","['Of 727 KEEPS participants, 474 (mean age: 52.7 [SD: 2.6]; 78.1% white) had computed tomography-based heart fat and CAC measures at both baseline and 48 months', 'recently menopausal women from KEEPS (Kronos Early Estrogen Prevention Study', '727 early menopausal women']","['hormone therapy formulations', ' Heart fats (epicardial and paracardial adipose tissue [PAT', 'Hormone Therapy', 'placebo', 'KEEPS', 'PAT', 'd oral conjugated equine estrogens and 50 µg/d transdermal 17β-estradiol, compared with placebo']","['Heart Fat and Coronary Artery Calcification Progression', 'epicardial adipose tissue and PAT', 'PAT changes and CAC progression', 'baseline CAC score', 'CAC progression', 'CAC', 'CAC score', 'heart fat accumulations', 'coronary artery calcification (CAC) progression', 'epicardial adipose tissue']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1136013', 'cui_str': 'Conjugated Equine Estrogens'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}]","[{'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",727.0,0.488914,"Compared with women on placebo, women on oral conjugated equine estrogens were less likely to have any increase in epicardial adipose tissue (odds ratio for oral conjugated equine estrogens versus placebo: 0.62 [95% CI, 0.40-0.97];  P =0.03).","[{'ForeName': 'Samar R', 'Initials': 'SR', 'LastName': 'El Khoudary', 'Affiliation': 'Department of Epidemiology University of Pittsburgh, Graduate School of Public Health Pittsburgh PA.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Epidemiology University of Pittsburgh, Graduate School of Public Health Pittsburgh PA.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Venugopal', 'Affiliation': 'Department of Epidemiology University of Pittsburgh, Graduate School of Public Health Pittsburgh PA.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Harvard Medical School and Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology University of Pittsburgh, Graduate School of Public Health Pittsburgh PA.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'University of Colorado Aurora CO.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Black', 'Affiliation': 'Departments of Epidemiology and Biostatistics University of California San Francisco San Francisco CA.'}, {'ForeName': 'S Mitchell', 'Initials': 'SM', 'LastName': 'Harman', 'Affiliation': 'Phoenix Veterans Affairs Health Care System Phoenix AZ.'}, {'ForeName': 'Marcelle I', 'Initials': 'MI', 'LastName': 'Cedars', 'Affiliation': 'Departments of Epidemiology and Biostatistics University of California San Francisco San Francisco CA.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Hopkins', 'Affiliation': 'University of Utah School of Medicine Salt Lake City UT.'}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Kearns', 'Affiliation': 'Mayo Clinic Rochester MN.'}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Miller', 'Affiliation': 'Mayo Clinic Rochester MN.'}, {'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Yale University New Haven CT.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'Los Angeles Biomedical Research Institute Torrance CA.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.012763']
871,30939090,Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303.,"PURPOSE


Alliance/CALGB 50303 (NCT00118209), an intergroup, phase III study, compared dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) with standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as frontline therapy for diffuse large B-cell lymphoma.
PATIENTS AND METHODS


Patients received six cycles of DA-EPOCH-R or R-CHOP. The primary objective was progression-free survival (PFS); secondary clinical objectives included response rate, overall survival (OS), and safety.
RESULTS


Between 2005 and 2013, 524 patients were registered; 491 eligible patients were included in the final analysis. Most patients (74%) had stage III or IV disease; International Prognostic Index (IPI) risk groups included 26% IPI 0 to 1, 37% IPI 2, 25% IPI 3, and 12% IPI 4 to 5. At a median follow-up of 5 years, PFS was not statistically different between the arms (hazard ratio, 0.93; 95% CI, 0.68 to 1.27;  P  = .65), with a 2-year PFS rate of 78.9% (95% CI, 73.8% to 84.2%) for DA-EPOCH-R and 75.5% (95% CI, 70.2% to 81.1%) for R-CHOP. OS was not different (hazard ratio, 1.09; 95% CI, 0.75 to 1.59;  P  = .64), with a 2-year OS rate of 86.5% (95% CI, 82.3% to 91%) for DA-EPOCH-R and 85.7% (95% CI, 81.4% to 90.2%) for R-CHOP. Grade 3 and 4 adverse events were more common ( P  < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9%  v  10.7%, respectively), febrile neutropenia (35.0%  v  17.7%, respectively), mucositis (8.4%  v  2.1%, respectively), and neuropathy (18.6%  v  3.3%, respectively). Five treatment-related deaths (2.1%) occurred in each arm.
CONCLUSION


In the 50303 study population, the more intensive, infusional DA-EPOCH-R was more toxic and did not improve PFS or OS compared with R-CHOP. The more favorable results with R-CHOP compared with historical controls suggest a potential patient selection bias and may preclude generalizability of results to specific risk subgroups.",2019,"Grade 3 and 4 adverse events were more common ( P < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9% v 10.7%, respectively), febrile neutropenia (35.0% v 17.7%, respectively), mucositis (8.4% v 2.1%, respectively), and neuropathy (18.6% v 3.3%, respectively).","['524 patients were registered; 491 eligible patients were included in the final analysis', 'Between 2005 and 2013', 'diffuse large B-cell lymphoma', 'Patients received six cycles of', 'Diffuse Large B-Cell Lymphoma']","['Dose-Adjusted EPOCH-R Compared With R-CHOP', 'etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) with standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP', 'DA-EPOCH-R or R-CHOP']","['febrile neutropenia', 'PFS or OS', 'mucositis', 'stage III or IV disease; International Prognostic Index', 'progression-free survival (PFS); secondary clinical objectives included response rate, overall survival (OS), and safety', 'Grade 3 and 4 adverse events', 'infection', '2-year PFS rate', 'neuropathy', '2-year OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}]","[{'cui': 'C4520227', 'cui_str': 'Dose-adjusted EPOCH'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}]",524.0,0.170783,"Grade 3 and 4 adverse events were more common ( P < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9% v 10.7%, respectively), febrile neutropenia (35.0% v 17.7%, respectively), mucositis (8.4% v 2.1%, respectively), and neuropathy (18.6% v 3.3%, respectively).","[{'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Wyndham H', 'Initials': 'WH', 'LastName': 'Wilson', 'Affiliation': '2 National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': '3 Duke University, Durham, NC.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': '4 Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Maurer', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Levi D', 'Initials': 'LD', 'LastName': 'Pederson', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Mei-Yin C', 'Initials': 'MC', 'LastName': 'Polley', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Brandelyn N', 'Initials': 'BN', 'LastName': 'Pitcher', 'Affiliation': '3 Duke University, Durham, NC.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': '6 MedStar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': '7 University of Rochester, Rochester, NY.'}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'Staudt', 'Affiliation': '2 National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Nina D', 'Initials': 'ND', 'LastName': 'Wagner-Johnston', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': '8 The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Jeremy S', 'Initials': 'JS', 'LastName': 'Abramson', 'Affiliation': '9 Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Nishitha M', 'Initials': 'NM', 'LastName': 'Reddy', 'Affiliation': '10 Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Winter', 'Affiliation': '11 Northwestern University, Chicago, IL.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Chang', 'Affiliation': '12 University of Wisconsin, Madison, WI.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Gopal', 'Affiliation': '13 Univeristy of Washington, Seattle, WA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chadburn', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mathew', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Fisher', 'Affiliation': '15 Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Kristy L', 'Initials': 'KL', 'LastName': 'Richards', 'Affiliation': '16 University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Schöder', 'Affiliation': '17 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': '17 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01994']
872,32201109,Efficacy and Safety of Buprenorphine Transdermal Patch for Immediate Postoperative Analgesia After Total Knee Arthroplasty Surgery.,"BACKGROUND


Total knee arthroplasty (TKA) is associated with moderate-to-severe postoperative pain. Satisfactory perioperative analgesia is essential for a good and predictable surgical outcome. Effective postoperative pain control is a major challenge to the treating surgeon and his team. Old age and multiple comorbidities restrict the choice of analgesics one can offer. Transdermal buprenorphine (TDB), widely used in chronic pain management, has been rarely studied in acute postoperative setting. The purpose of this study was to compare the safety and efficacy of a TDB patch to conventional analgesics after knee arthroplasty surgery.
METHODS


A prospective randomized study was conducted with 200 patients aged 60-75 years undergoing TKA surgery under neuraxial anesthesia. All patients received periarticular local anesthetic infiltration and epidural/femoral nerve block infusion for 72 hours postoperatively. Group A received the TDB patch 5 mcg applied at the end of surgery. Group B received a combination of paracetamol and tramadol. All patients received intravenous diclofenac as rescue analgesia. Pain scores at rest, on movement, and side effects, if any, were compared over 7 days using the numerical rating scale score.
RESULTS


Pain scores at rest and on movement were significantly lower in group A (P values .008 and .01). Rescue analgesia requirement was also significantly less in this group. Only one patient had clinically significant respiratory depression, and 3 patients had local erythema.
CONCLUSION


Our data shows that the TDB patch is more efficacious in reducing postoperative pain after TKA surgery and can be safely used with fewer systemic side effects when compared to conventional analgesics.",2020,"RESULTS


Pain scores at rest and on movement were significantly lower in group A (P values .008 and .01).","['After Total Knee Arthroplasty Surgery', '200 patients aged 60-75 years undergoing TKA surgery under neuraxial anesthesia']","['TDB patch', 'periarticular local anesthetic infiltration and epidural/femoral nerve block infusion', 'Buprenorphine Transdermal Patch', 'diclofenac', 'paracetamol and tramadol', 'Total knee arthroplasty (TKA', 'TDB patch to conventional analgesics', 'Transdermal buprenorphine (TDB']","['Efficacy and Safety', 'Rescue analgesia requirement', 'local erythema', 'Pain scores', 'postoperative pain', 'numerical rating scale score', 'safety and efficacy', 'Pain scores at rest, on movement, and side effects']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration (procedure)'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0991556', 'cui_str': 'Transdermal System'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",200.0,0.0793419,"RESULTS


Pain scores at rest and on movement were significantly lower in group A (P values .008 and .01).","[{'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Londhe', 'Affiliation': 'CritiCare Multispecialty Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Meghana', 'Initials': 'M', 'LastName': 'Patwardhan', 'Affiliation': 'CritiCare Multispecialty Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'CritiCare Multispecialty Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Mugdha', 'Initials': 'M', 'LastName': 'Oak', 'Affiliation': 'CritiCare Multispecialty Hospital, Mumbai, Maharashtra, India.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.02.015']
873,32088174,"Multicenter, open-label trial to assess the safety and tolerability of drospirenone 4.0 mg over 6 cycles in female adolescents, with a 7-cycle extension phase.","OBJECTIVE


To assess the safety, tolerability and bleeding patterns of drospirenone 4.0 mg.
STUDY DESIGN


A multicenter, open-label, safety trial in sexually-active adolescents aged 12-17 years for six 28-day treatment cycles (Core Phase) and an optional 7-13 cycle extension with administration of drospirenone 4.0 mg in a regimen of 24 active/4 placebo tablets.
RESULTS


We enrolled 111 subjects, and after eight failed Screening and one withdrew consent, 102 remained evaluable; 89 (87.3%) completed the Core Phase. Overall, treatment with drospirenone 4.0 mg was well tolerated. Possibly-related TEAEs were reported for 23 subjects (22.5% of the 102 evaluable); two serious adverse events were reported during the Extension Phase (pharyngitis and joint dislocation), neither related to treatment. The number of subjects reporting dysmenorrhea decreased from 47 prior to Screening, to 14 at the end of Cycle 6, to 8 at the end of Cycle 13. Assessments of vital signs and gynecological and physical examinations were unremarkable. We observed a trend towards less bleeding and/or spotting over the first cycles with the use of drospirenone: the proportion of subjects with both scheduled and unscheduled bleeding and spotting decreased, while the proportion with absence of bleeding or spotting increased. Only five subjects (4.9% of 102 evaluable) prematurely terminated the trial due to irregular bleeding. At the end of 6 months, 85.3% rated the tolerability of drospirenone as ""excellent"" or ""good"".
CONCLUSIONS


The results indicate that 4.0 mg drospirenone over 13 treatment cycles was well tolerated, safe and acceptable for the majority of adolescents.
IMPLICATIONS


Drospirenone 4.0 mg oral pills provide a well-tolerated, safe and acceptable contraceptive choice for adolescents.",2020,"We observed a trend towards less bleeding and/or spotting over the first cycles with the use of drospirenone: the proportion of subjects with both scheduled and unscheduled bleeding and spotting decreased, while the proportion with absence of bleeding or spotting increased.","['We enrolled 111 subjects, and after eight failed Screening and one withdrew consent, 102 remained evaluable; 89 (87.3%) completed the Core Phase', 'Female Adolescents', 'sexually-active adolescents aged 12-17 years for six 28-day treatment cycles (Core Phase) and an optional 7-13 cycle extension with administration of', 'adolescents']","['drospirenone', 'Drospirenone', 'drospirenone 4.0 mg in a regimen of 24 active/4 placebo tablets']","['serious adverse events', 'bleeding and/or spotting', 'unscheduled bleeding and spotting', 'tolerated', 'tolerated, safe and acceptable for the majority of adolescents', 'irregular bleeding', 'tolerated, safe and acceptable contraceptive choice', 'tolerability', 'safety, tolerability and bleeding patterns', 'number of subjects reporting dysmenorrhea', 'Safety and Tolerability']","[{'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205271', 'cui_str': 'Irregular (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}]",111.0,0.0285746,"We observed a trend towards less bleeding and/or spotting over the first cycles with the use of drospirenone: the proportion of subjects with both scheduled and unscheduled bleeding and spotting decreased, while the proportion with absence of bleeding or spotting increased.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Apter', 'Affiliation': 'VL-Medi Clinical Research Center, Töölönkatu 37, 00260 Helsinki, Finland. Electronic address: dan.apter@vlmedi.fi.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis Spain, Madrid, Spain.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, and Karolinska University Hospital, 171 77 Stockholm, Sweden.""}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Peters', 'Affiliation': 'Praxis Dr. Peters, Berner Heerweg 157, 22159 Hamburg, Germany.'}]",Contraception,['10.1016/j.contraception.2020.02.004']
874,32087818,"Efficacy and safety of nerinetide for the treatment of acute ischaemic stroke (ESCAPE-NA1): a multicentre, double-blind, randomised controlled trial.","BACKGROUND


Nerinetide, an eicosapeptide that interferes with post-synaptic density protein 95, is a neuroprotectant that is effective in preclinical stroke models of ischaemia-reperfusion. In this trial, we assessed the efficacy and safety of nerinetide in human ischaemia-reperfusion that occurs with rapid endovascular thrombectomy in patients who had an acute ischaemic stroke.
METHODS


For this multicentre, double-blind, randomised, placebo-controlled study done in 48 acute care hospitals in eight countries, we enrolled patients with acute ischaemic stroke due to large vessel occlusion within a 12 h treatment window. Eligible patients were aged 18 years or older with a disabling ischaemic stroke at the time of randomisation, had been functioning independently in the community before the stroke, had an Alberta Stroke Program Early CT Score (ASPECTS) greater than 4, and vascular imaging showing moderate-to-good collateral filling, as determined by multiphase CT angiography. Patients were randomly assigned (1:1) to receive intravenous nerinetide in a single dose of 2·6 mg/kg, up to a maximum dose of 270 mg, on the basis of estimated or actual weight (if known) or saline placebo by use of a real-time, dynamic, internet-based, stratified randomised minimisation procedure. Patients were stratified by intravenous alteplase treatment and declared endovascular device choice. All trial personnel and patients were masked to sequence and treatment allocation. All patients underwent endovascular thrombectomy and received alteplase in usual care when indicated. The primary outcome was a favourable functional outcome 90 days after randomisation, defined as a modified Rankin Scale (mRS) score of 0-2. Secondary outcomes were measures of neurological disability, functional independence in activities of daily living, excellent functional outcome (mRS 0-1), and mortality. The analysis was done in the intention-to-treat population and adjusted for age, sex, baseline National Institutes of Health Stroke Scale score, ASPECTS, occlusion location, site, alteplase use, and declared first device. The safety population included all patients who received any amount of study drug. This trial is registered with ClinicalTrials.gov, NCT02930018.
FINDINGS


Between March 1, 2017, and Aug 12, 2019, 1105 patients were randomly assigned to receive nerinetide (n=549) or placebo (n=556). 337 (61·4%) of 549 patients with nerinetide and 329 (59·2%) of 556 with placebo achieved an mRS score of 0-2 at 90 days (adjusted risk ratio 1·04, 95% CI 0·96-1·14; p=0·35). Secondary outcomes were similar between groups. We observed evidence of treatment effect modification resulting in inhibition of treatment effect in patients receiving alteplase. Serious adverse events occurred equally between groups.
INTERPRETATION


Nerinetide did not improve the proportion of patients achieving good clinical outcomes after endovascular thrombectomy compared with patients receiving placebo.
FUNDING


Canadian Institutes for Health Research, Alberta Innovates, and NoNO.",2020,"Serious adverse events occurred equally between groups.
","['Between March 1, 2017, and Aug 12, 2019, 1105 patients', '48 acute care hospitals in eight countries, we enrolled patients with acute ischaemic stroke due to large vessel occlusion within a 12 h treatment window', 'Eligible patients were aged 18 years or older with a disabling ischaemic stroke at the time of randomisation, had been functioning independently in the community before the stroke, had an Alberta Stroke Program', '337 (61·4%) of 549 patients with nerinetide and 329 (59·2%) of 556 with', 'patients who had an acute ischaemic stroke', 'patients who received any amount of study drug', 'patients receiving alteplase', 'acute ischaemic stroke (ESCAPE-NA1']","['placebo', 'nerinetide', 'alteplase', 'saline placebo', 'intravenous nerinetide']","['efficacy and safety', 'mRS score', 'Serious adverse events', 'neurological disability, functional independence in activities of daily living, excellent functional outcome (mRS 0-1), and mortality', 'Efficacy and safety', 'favourable functional outcome 90 days after randomisation, defined as a modified Rankin Scale (mRS) score of 0-2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",1105.0,0.768557,"Serious adverse events occurred equally between groups.
","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Foothills Medical Centre, University of Calgary, Calgary, AB, Canada. Electronic address: michael.hill@ucalgary.ca.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Foothills Medical Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Bijoy K', 'Initials': 'BK', 'LastName': 'Menon', 'Affiliation': 'Foothills Medical Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Raul G', 'Initials': 'RG', 'LastName': 'Nogueira', 'Affiliation': 'Emory University School of Medicine, Grady Memorial Hospital, Atlanta, GA, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'McTaggart', 'Affiliation': 'Warren Alpert School of Medicine, Brown University, Providence, RI, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Demchuk', 'Affiliation': 'Foothills Medical Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Alexandre Y', 'Initials': 'AY', 'LastName': 'Poppe', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Buck', 'Affiliation': 'University of Alberta Hospital, Edmonton, AB, Canada.'}, {'ForeName': 'Thalia S', 'Initials': 'TS', 'LastName': 'Field', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Dar', 'Initials': 'D', 'LastName': 'Dowlatshahi', 'Affiliation': 'Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'van Adel', 'Affiliation': 'McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Swartz', 'Affiliation': 'Sunnybrook Health Sciences Centre, University of Toronto, Toronto ON, Canada.'}, {'ForeName': 'Ruchir A', 'Initials': 'RA', 'LastName': 'Shah', 'Affiliation': 'Erlanger Hospital, Chattanooga, TN, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Sauvageau', 'Affiliation': 'Lyerly Neurosurgery, Baptist Hospital, Jacksonville, FL, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Zerna', 'Affiliation': 'Foothills Medical Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Ospel', 'Affiliation': 'Foothills Medical Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Joshi', 'Affiliation': 'Foothills Medical Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Almekhlafi', 'Affiliation': 'Foothills Medical Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Karla J', 'Initials': 'KJ', 'LastName': 'Ryckborst', 'Affiliation': 'Foothills Medical Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Lowerison', 'Affiliation': 'Clinical Research Unit, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Heard', 'Affiliation': 'NoNO, Toronto, ON, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garman', 'Affiliation': 'NoNO, Toronto, ON, Canada.'}, {'ForeName': 'Diogo', 'Initials': 'D', 'LastName': 'Haussen', 'Affiliation': 'Emory University School of Medicine, Grady Memorial Hospital, Atlanta, GA, USA.'}, {'ForeName': 'Shawna M', 'Initials': 'SM', 'LastName': 'Cutting', 'Affiliation': 'Warren Alpert School of Medicine, Brown University, Providence, RI, USA.'}, {'ForeName': 'Shelagh B', 'Initials': 'SB', 'LastName': 'Coutts', 'Affiliation': 'Foothills Medical Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Roy', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Rempel', 'Affiliation': 'University of Alberta Hospital, Edmonton, AB, Canada.'}, {'ForeName': 'Axel Cr', 'Initials': 'AC', 'LastName': 'Rohr', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Iancu', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada; Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada.""}, {'ForeName': 'Demetrios J', 'Initials': 'DJ', 'LastName': 'Sahlas', 'Affiliation': 'McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Amy Y X', 'Initials': 'AYX', 'LastName': 'Yu', 'Affiliation': 'Sunnybrook Health Sciences Centre, University of Toronto, Toronto ON, Canada.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Devlin', 'Affiliation': 'Erlanger Hospital, Chattanooga, TN, USA.'}, {'ForeName': 'Ricardo A', 'Initials': 'RA', 'LastName': 'Hanel', 'Affiliation': 'Lyerly Neurosurgery, Baptist Hospital, Jacksonville, FL, USA.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Puetz', 'Affiliation': 'University Hospital Carl Gustav Carus at the Technische Universität Dresden, Dresden Neurovascular Center, Dresden, Germany.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Silver', 'Affiliation': 'University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Bruce C V', 'Initials': 'BCV', 'LastName': 'Campbell', 'Affiliation': 'The Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Chapot', 'Affiliation': 'Department of Neuroradiology and Endovascular Therapy, Alfred Krupp Krankenhaus Hospital, Essen, Germany.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Teitelbaum', 'Affiliation': 'Montreal Neurological Institute, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Mandzia', 'Affiliation': 'London Health Science Centre, Western University, London, ON, Canada.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kleinig', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Turkel-Parrella', 'Affiliation': 'New York University School of Medicine, New York University, New York, NY, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Heck', 'Affiliation': 'Forsyth Medical Center, Winston-Salem, NC, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kelly', 'Affiliation': 'Royal University Hospital, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bharatha', 'Affiliation': ""St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Oh Young', 'Initials': 'OY', 'LastName': 'Bang', 'Affiliation': 'Samsung Medical Center, Departments of Neurology and Radiology, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Jadhav', 'Affiliation': 'University of Pittsburgh Medical Centre, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Wellstar Health Systems, Kennestone Hospital, Marietta, GA, USA.'}, {'ForeName': 'Donald F', 'Initials': 'DF', 'LastName': 'Frei', 'Affiliation': 'Swedish Medical Center, Colorado Neurological Institute, Denver, CO, USA.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Tarpley', 'Affiliation': ""Providence Little Company of Mary Medical Center, Providence Saint John's Health Center and The Pacific Neuroscience Institute, Torrance, CA, USA.""}, {'ForeName': 'Cameron G', 'Initials': 'CG', 'LastName': 'McDougall', 'Affiliation': 'Swedish Neurological Institute, Seattle, WA, USA.'}, {'ForeName': 'Staffan', 'Initials': 'S', 'LastName': 'Holmin', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet and Departments of Neuroradiology and Neurology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Joung-Ho', 'Initials': 'JH', 'LastName': 'Rha', 'Affiliation': 'Inha University Hospital Neurology, Incheon, South Korea.'}, {'ForeName': 'Ajit S', 'Initials': 'AS', 'LastName': 'Puri', 'Affiliation': 'University of Massachusetts Medical Center, University of Massachusetts, Worcester, MA, USA.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Camden', 'Affiliation': 'Enfant-Jésus Hospital, Centre Hospitalier Universitaire de Québec, Laval University, Québec City, QC, Canada.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Thomalla', 'Affiliation': 'Department of Neurology and Department of Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Choe', 'Affiliation': 'Neurosciences Institute, Abington Jefferson Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Phillips', 'Affiliation': 'Queen Elizabeth II Health Science Centre, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Schindler', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thornton', 'Affiliation': 'Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Nagel', 'Affiliation': 'University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Ji Hoe', 'Initials': 'JH', 'LastName': 'Heo', 'Affiliation': 'Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-Il', 'Initials': 'SI', 'LastName': 'Sohn', 'Affiliation': 'Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Marios-Nikos', 'Initials': 'MN', 'LastName': 'Psychogios', 'Affiliation': 'University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'Budzik', 'Affiliation': 'Ohio Health, Riverside Methodist Hospital, Columbus, OH, USA.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Starkman', 'Affiliation': 'UCLA Comprehensive Stroke Center, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Coleman O', 'Initials': 'CO', 'LastName': 'Martin', 'Affiliation': ""Saint Luke's Hospital of Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Burns', 'Affiliation': 'Royal Victoria Hospital, Belfast, UK.'}, {'ForeName': 'Seán', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Lopez', 'Affiliation': 'Rush University Medical Center, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Joey', 'Initials': 'J', 'LastName': 'English', 'Affiliation': 'California Pacific Medical Center, Sutter Health, San Francisco, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tymianski', 'Affiliation': 'NoNO, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30258-0']
875,31558252,Improving Communication in Heart Failure Patient Care.,"BACKGROUND


Although implantable cardioverter-defibrillators (ICDs) reduce sudden death, these patients die of heart failure (HF) or other diseases. To prevent shocks at the end of life, clinicians should discuss deactivating the defibrillation function.
OBJECTIVES


The purpose of this study was to determine if a clinician-centered teaching intervention and automatic reminders increased ICD deactivation discussions and increased device deactivation.
METHODS


In this 6-center, single-blinded, cluster-randomized, controlled trial, primary outcomes were proportion of patients: 1) having ICD deactivation discussions; and 2) having the shocking function deactivated. Secondary outcomes included goals of care conversations and advance directive completion.
RESULTS


A total of 525 subjects were included with advanced HF who had an ICD: 301 intervention and 224 control. At baseline, 52% (n = 272) were not candidates for advanced therapies (i.e., cardiac transplant or mechanical circulatory support). There were no differences in discussions (41 [14%] vs. 26 [12%]) or deactivation (33 [11%] vs. 26 [12%]). In pre-specified subgroup analyses of patients who were not candidates for advanced therapies, the intervention increased deactivation discussions (32 [25%] vs. 16 [11%]; odds ratio: 2.90; p = 0.003). Overall, 99 patients died; there were no differences in conversations or deactivations among decedents.
SECONDARY OUTCOMES


Among all participants, there was an increase in goals of care conversations (47% intervention vs. 38% control; odds ratio: 1.53; p = 0.04). There were no differences in completion of advance directives.
CONCLUSIONS


The intervention increased conversations about ICD deactivation and goals of care. HF clinicians were able to apply new communication techniques based on patients' severity of illness. (An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations [WISDOM]; NCT01459744).",2019,There were no differences in discussions (41 [14%] vs. 26 [12%]) or deactivation (33 [11%] vs. 26 [12%]).,"['525 subjects were included with advanced HF who had an ICD: 301 intervention and 224 control', 'patients die of heart failure (HF) or other diseases']",['implantable cardioverter-defibrillators (ICDs'],"['goals of care conversations and advance directive completion', 'conversations about ICD deactivation and goals of care', 'deactivation discussions', 'goals of care conversations']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]",525.0,0.195202,There were no differences in discussions (41 [14%] vs. 26 [12%]) or deactivation (33 [11%] vs. 26 [12%]).,"[{'ForeName': 'Nathan E', 'Initials': 'NE', 'LastName': 'Goldstein', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York; James J. Peters Veterans Affairs Medical Center, Bronx, New York. Electronic address: Nathan.Goldstein@mssm.edu.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Mather', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McKendrick', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Gelfman', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York; James J. Peters Veterans Affairs Medical Center, Bronx, New York.'}, {'ForeName': 'Mathew D', 'Initials': 'MD', 'LastName': 'Hutchinson', 'Affiliation': 'Division of Cardiovascular Medicine, Sarver Heart Center, University of Arizona College of Medicine Tucson, Tucson, Arizona.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lampert', 'Affiliation': 'Department of Internal Medicine, Section of Cardiology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Hannah I', 'Initials': 'HI', 'LastName': 'Lipman', 'Affiliation': 'Hackensack University Medical Center, Hackensack, New Jersey; Hackensack Meridian School of Medicine at Seton Hall, Nutley, New Jersey.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, Colorado.'}, {'ForeName': 'Jacob J', 'Initials': 'JJ', 'LastName': 'Strand', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Center for Palliative Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Birmingham Veterans Affairs Medical Center, Department of Medicine and UAB Center for Palliative and Supportive Care, University of Alabama Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Kalman', 'Affiliation': 'Lenox Hill Hospital, Northwell Health, New York, New York.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Kutner', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Pinney', 'Affiliation': 'Division of Cardiology, Samuel Bronfman Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'R Sean', 'Initials': 'RS', 'LastName': 'Morrison', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York; James J. Peters Veterans Affairs Medical Center, Bronx, New York.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.07.058']
876,30776911,Ancillary service needs among persons new to HIV care and the relationship between needs and late presentation to care.,"Ancillary service needs likely influence time to diagnosis and presentation for HIV care. The effect of both met and unmet needs on late presentation to HIV care is not well understood. We used baseline data from 348 people with HIV (PWH) with no prior HIV care who enrolled in iENGAGE (a randomized controlled trial (RCT) of an intervention to support retention in care) at one of four HIV clinics in the US. A standardized baseline questionnaire collected information on ancillary service needs, and whether each need was presently unmet. We examined covariates known to be associated with disease stage at presentation to care and their association with needs. We subsequently assessed the relationship of needs with CD4 accounting for those other covariates by estimating prevalence ratios (PR) using inverse probability weights. Most patients enrolling in the RCT were male (79%) and the majority were Black (62%); median age was 34 years. Prevalence of any reported individual need was 69%. One-third of the sample had a baseline CD4 cell count <200, 42% between 200 and 499 and 27% ≥500. There was no statistically significant association between need or unmet need and baseline CD4. In general, psychiatric health and SU issues (depression, anxiety, and drug use) were consistently associated with higher prevalence of need (met and unmet). Additionally, the Black race was associated with higher basic resource needs (housing: PR 1.67, 95%CI 1.08-2.59; transportation: PR 1.65, 95% CI 1.12-2.45). Ancillary service needs (met and unmet) were common among patients new to HIV care and impacted vulnerable subgroups. However, we found no evidence that reporting a specific individual need, whether met or unmet, was associated with a timely presentation to HIV care. The impact of needs on subsequent steps of the HIV care continuum will be examined with longitudinal data.",2019,"Additionally, the Black race was associated with higher basic resource needs (housing: PR 1.67, 95%CI 1.08-2.59; transportation: PR 1.65, 95% CI 1.12-2.45).","['348 people with HIV (PWH) with no prior HIV care who enrolled', 'Most patients enrolling in the RCT were male (79%) and the majority were Black (62%); median age was 34 years']",[],['baseline CD4 cell count'],"[{'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}]",,0.135374,"Additionally, the Black race was associated with higher basic resource needs (housing: PR 1.67, 95%CI 1.08-2.59; transportation: PR 1.65, 95% CI 1.12-2.45).","[{'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Monroe', 'Affiliation': 'a Johns Hopkins University School of Medicine , Baltimore , MD , USA.'}, {'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Lesko', 'Affiliation': 'c Johns Hopkins Bloomberg School of Public Health , Baltimore , MD , USA.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'a Johns Hopkins University School of Medicine , Baltimore , MD , USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Lau', 'Affiliation': 'c Johns Hopkins Bloomberg School of Public Health , Baltimore , MD , USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Keruly', 'Affiliation': 'd Adult Ryan White Services , Johns Hopkins University , Baltimore , MD , USA.'}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Crane', 'Affiliation': 'e Harborview Medical Center , University of Washington , Seattle , WA , USA.'}, {'ForeName': 'K Rivet', 'Initials': 'KR', 'LastName': 'Amico', 'Affiliation': 'f Department of Health Behavior and Health Education , School of Public Health, University of Michigan , Ann Arbor , MI , USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Napravnik', 'Affiliation': 'g School of Medicine , Chapel Hill , NC , USA.'}, {'ForeName': 'E Byrd', 'Initials': 'EB', 'LastName': 'Quinlivan', 'Affiliation': 'h Institute for Global Health and Infectious Diseases , University of North Carolina at Chapel Hill , Chapel Hill , NC , USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mugavero', 'Affiliation': 'i Division of Infectious Diseases , University of Alabama at Birmingham (UAB) , Birmingham , AL , USA.'}]",AIDS care,['10.1080/09540121.2019.1576840']
877,30977721,Parents' perceptions of parent-child interactions related to eating and body image: an experimental vignette study.,"Parents are key to children's health because they can influence children's eating behavior and body image and can make health-related decisions for children. Despite their influence, research on parents'  opinions  about parenting practices related to weight and eating is limited. Experimental vignettes examined parents' perceptions of parent-child interactions around body image, eating, and weight loss. We manipulated vignette-child weight (healthy-weight, overweight) and communication tone (positive, negative, neutral) to assess their influence on parents' perceptions. Parents ( N  = 233, 27.5% fathers, 72.5% mothers) were randomly assigned to read one of six vignettes. When the vignette-child had overweight, parents were more likely to recommend seeking help for body image and that the vignette-parent should choose the restaurant food order. Parents were less opposed to commenting on the vignette-child's weight when tone was positive. Parents were more likely to recommend weight-loss efforts that could be implemented by the family rather than those requiring professional assistance. This study is among the first to examine parents' opinions about parenting practices related to weight and eating using an experimental design. Findings might inform future research and continued work on prevention and treatment applications to help align parents' existing opinions about weight and eating with evidence-based health-promoting strategies.",2020,Parents were more likely to recommend weight-loss efforts that could be implemented by the family rather than those requiring professional assistance.,"['Parents (N =\xa0233, 27.5% fathers, 72.5% mothers']",[],[],"[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",[],[],,0.0150207,Parents were more likely to recommend weight-loss efforts that could be implemented by the family rather than those requiring professional assistance.,"[{'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Lydecker', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Paige M', 'Initials': 'PM', 'LastName': 'Cunningham', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}]",Eating disorders,['10.1080/10640266.2019.1598767']
878,31196815,Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE-TIMI 58 randomised trial.,"BACKGROUND


Sodium-glucose co-transporter-2 (SGLT2) inhibitors have shown beneficial effects on renal outcomes mainly in patients with established atherosclerotic cardiovascular disease. Here we report analyses of renal outcomes with the SGLT2 inhibitor dapagliflozin in the DECLARE-TIMI 58 cardiovascular outcomes trial, which included patients with type 2 diabetes both with and without established atherosclerotic cardiovascular disease and mostly with preserved renal function.
METHODS


In DECLARE-TIMI 58, patients with type 2 diabetes, HbA 1c  6·5-12·0% (47·5-113·1 mmol/mol), with either established atherosclerotic cardiovascular disease or multiple risk factors, and creatinine clearance of at least 60 mL/min were randomly assigned (1:1) to 10 mg dapagliflozin or placebo once daily. A prespecified secondary cardiorenal composite outcome was defined as a sustained decline of at least 40% in estimated glomerular filtration rate [eGFR] to less than 60 mL/min per 1·73m 2 , end-stage renal disease (defined as dialysis for at least 90 days, kidney transplantation, or confirmed sustained eGFR <15mL/min per 1·73 m 2 ), or death from renal or cardiovascular causes; a prespecified renal-specific composite outcome was the same but excluding death from cardiovascular causes. In this renal analysis, we report findings for the components of these composite outcomes, subgroup analysis of these composite outcomes, and changes in eGFR at different timepoints. DECLARE-TIMI 58 is registered with ClinicalTrials.gov, number NCT01730534.
FINDINGS


The trial took place between April 25, 2013, and Sept 18, 2018; median follow-up was 4·2 years (IQR 3·9-4·4). Of the 17 160 participants who were randomly assigned, 8162 (47·6%) had an eGFR of at least 90 mL/min per 1·73 m 2 , 7732 (45·1%) had an eGFR of 60 to less than 90 mL/min per 1·73 m 2 , and 1265 (7·4%) had an eGFR of less than 60 mL/min per 1·73 m 2  at baseline (one participant had missing data for eGFR); 6974 (40·6%) had established atherosclerotic cardiovascular disease and 10 186 (59·4%) had multiple risk factors. As previously reported, the cardiorenal secondary composite outcome was significantly reduced with dapagliflozin versus placebo (hazard ratio [HR] 0·76, 95% CI 0·67-0.87; p<0·0001); excluding death from cardiovascular causes, the HR for the renal-specific outcome was 0·53 (0·43-0·66; p<0·0001). We identified a 46% reduction in sustained decline in eGFR by at least 40% to less than 60 mL/min per 1·73 m 2  (120 [1·4% vs 221 [2·6%]; HR 0·54 [95% CI 0·43-0·67]; p<0·0001). The risk of end-stage renal disease or renal death was lower in the dapagliflozin group than in the placebo group (11 [0·1%] vs 27 [0·3%]; HR 0·41 [95% CI 0·20-0·82]; p=0·012). Both the cardiorenal and renal-specific composite outcomes were improved with dapagliflozin versus placebo across various prespecified subgroups, including those defined by baseline eGFR (cardiorenal outcome p interaction =0·97; renal-specific outcome p interaction =0·87) and the presence or absence of established atherosclerotic cardiovascular disease (cardiorenal outcome p interaction =0·67; renal-specific outcome p interaction =0·72). 6 months after randomisation, the mean decrease in eGFR was larger in the dapagliflozin group than in the placebo group. The mean change equalised by 2 years, and at 3 and 4 years the mean decrease in eGFR was less with dapagliflozin than with placebo.
INTERPRETATION


Dapagliflozin seemed to prevent and reduce progression of kidney disease compared with placebo in this large and diverse population of patients with type 2 diabetes with and without established atherosclerotic cardiovascular disease, most of whom had preserved renal function.
FUNDING


AstraZeneca.",2019,"Both the cardiorenal and renal-specific composite outcomes were improved with dapagliflozin versus placebo across various prespecified subgroups, including those defined by baseline eGFR (cardiorenal outcome p interaction =0·97; renal-specific outcome p interaction =0·87) and the presence or absence of established atherosclerotic cardiovascular disease (cardiorenal outcome p interaction =0·67; renal-specific outcome p interaction =","['patients with type 2 diabetes, HbA 1c  6·5-12·0% (47·5-113·1 mmol/mol), with either established atherosclerotic cardiovascular disease or multiple risk factors, and creatinine clearance of at least 60 mL/min', 'patients with type 2 diabetes both with and without established atherosclerotic cardiovascular disease and mostly with preserved renal function', 'patients with type 2 diabetes', 'patients with established atherosclerotic cardiovascular disease', 'patients with type 2 diabetes with and without established atherosclerotic cardiovascular disease, most of whom had preserved renal function', 'Of the 17\u2008160 participants']","['dapagliflozin versus placebo', 'placebo', 'Sodium-glucose co-transporter-2 (SGLT2) inhibitors', 'dapagliflozin or placebo', 'SGLT2 inhibitor dapagliflozin', 'dapagliflozin']","['glomerular filtration rate [eGFR', 'multiple risk factors', 'mean decrease in eGFR', 'sustained decline in eGFR', 'cardiorenal and renal-specific composite outcomes', 'risk of end-stage renal disease or renal death', 'eGFR', 'established atherosclerotic cardiovascular disease', 'development and progression of kidney disease', 'presence or absence of established atherosclerotic cardiovascular disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}]",17160.0,0.449725,"Both the cardiorenal and renal-specific composite outcomes were improved with dapagliflozin versus placebo across various prespecified subgroups, including those defined by baseline eGFR (cardiorenal outcome p interaction =0·97; renal-specific outcome p interaction =0·87) and the presence or absence of established atherosclerotic cardiovascular disease (cardiorenal outcome p interaction =0·67; renal-specific outcome p interaction =","[{'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel. Electronic address: ofrim@hadassah.org.il.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Rozenberg', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Yanuv', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Goodrich', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Zelniker', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Dwyer', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Eri T', 'Initials': 'ET', 'LastName': 'Kato', 'Affiliation': 'Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Ingrid A M', 'Initials': 'IAM', 'LastName': 'Gause-Nilsson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fredriksson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30180-9']
879,31329516,"ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer.","PURPOSE


Enzalutamide, a potent androgen-receptor inhibitor, has demonstrated significant benefits in metastatic and nonmetastatic castration-resistant prostate cancer. We evaluated the efficacy and safety of enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC).
METHODS


ARCHES (ClinicalTrials.gov identifier: NCT02677896) is a multinational, double-blind, phase III trial, wherein 1,150 men with mHSPC were randomly assigned 1:1 to enzalutamide (160 mg/day) or placebo, plus androgen deprivation therapy (ADT), stratified by disease volume and prior docetaxel chemotherapy. The primary end point was radiographic progression-free survival.
RESULTS


As of October 14, 2018, the risk of radiographic progression or death was significantly reduced with enzalutamide plus ADT versus placebo plus ADT (hazard ratio, 0.39; 95% CI, 0.30 to 0.50;  P  < .001; median not reached  v  19.0 months). Similar significant improvements in radiographic progression-free survival were reported in prespecified subgroups on the basis of disease volume and prior docetaxel therapy. Enzalutamide plus ADT significantly reduced the risk of prostate-specific antigen progression, initiation of new antineoplastic therapy, first symptomatic skeletal event, castration resistance, and reduced risk of pain progression. More men achieved an undetectable prostate-specific antigen level and/or an objective response with enzalutamide plus ADT ( P  < .001). Patients in both treatment groups reported a high baseline level of quality of life, which was maintained over time. Grade 3 or greater adverse events were reported in 24.3% of patients who received enzalutamide plus ADT versus 25.6% of patients who received placebo plus ADT, with no unexpected adverse events.
CONCLUSION


Enzalutamide with ADT significantly reduced the risk of metastatic progression or death over time versus placebo plus ADT in men with mHSPC, including those with low-volume disease and/or prior docetaxel, with a safety analysis that seems consistent with the safety profile of enzalutamide in previous clinical trials in castration-resistant prostate cancer.",2019,"Enzalutamide with ADT significantly reduced the risk of metastatic progression or death over time versus placebo plus ADT in men with mHSPC, including those with low-volume disease and/or prior docetaxel, with a safety analysis that seems consistent with the safety profile of enzalutamide in previous clinical trials in castration-resistant prostate cancer.","['Men With Metastatic Hormone-Sensitive Prostate Cancer', 'metastatic and nonmetastatic castration-resistant prostate cancer', 'metastatic hormone-sensitive prostate cancer (mHSPC', '1,150 men with mHSPC']","['placebo, plus androgen deprivation therapy (ADT), stratified by disease volume and prior docetaxel chemotherapy', 'enzalutamide plus ADT', 'Enzalutamide plus ADT', 'placebo plus ADT', 'enzalutamide', 'Androgen Deprivation Therapy With Enzalutamide or Placebo', 'Enzalutamide with ADT', 'ARCHES']","['risk of prostate-specific antigen progression, initiation of new antineoplastic therapy, first symptomatic skeletal event, castration resistance, and reduced risk of pain progression', 'undetectable prostate-specific antigen level', 'radiographic progression-free survival', 'risk of metastatic progression or death', 'Grade 3 or greater adverse events', 'efficacy and safety', 'risk of radiographic progression or death', 'high baseline level of quality of life']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0003392', 'cui_str': 'Chemotherapeutic Anticancer Drug'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0034380'}]",1150.0,0.334023,"Enzalutamide with ADT significantly reduced the risk of metastatic progression or death over time versus placebo plus ADT in men with mHSPC, including those with low-volume disease and/or prior docetaxel, with a safety analysis that seems consistent with the safety profile of enzalutamide in previous clinical trials in castration-resistant prostate cancer.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC.'}, {'ForeName': 'Russell Z', 'Initials': 'RZ', 'LastName': 'Szmulewitz', 'Affiliation': 'The University of Chicago, Chicago, IL.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Holzbeierlein', 'Affiliation': 'The University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Arnauld', 'Initials': 'A', 'LastName': 'Villers', 'Affiliation': 'Lille University, Lille, France.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Azad', 'Affiliation': 'Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Alcaraz', 'Affiliation': 'Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'Hertzen Moscow Cancer Research Institute, Moscow, Russia.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Iguchi', 'Affiliation': 'Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach, SC.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Rosbrook', 'Affiliation': 'Pfizer, San Diego, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sugg', 'Affiliation': 'Astellas Pharma, Northbrook, IL.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Baron', 'Affiliation': 'Astellas Pharma, Leiden, the Netherlands.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Astellas Pharma, Northbrook, IL.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Eberhard Karls University of Tübingen, Tübingen, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00799']
880,32209645,Continuous Glucose Monitoring in Pregnancy: Importance of Analyzing Temporal Profiles to Understand Clinical Outcomes.,"OBJECTIVE


To determine if temporal glucose profiles differed between  1 ) women who were randomized to real-time continuous glucose monitoring (RT-CGM) or self-monitored blood glucose (SMBG),  2 ) women who used insulin pumps or multiple daily insulin injections (MDIs), and  3 ) women whose infants were born large for gestational age (LGA) or not, by assessing CGM data obtained from the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT).
RESEARCH DESIGN AND METHODS


Standard summary metrics and functional data analysis (FDA) were applied to CGM data from the CONCEPTT trial (RT-CGM,  n  = 100; SMBG,  n  = 100) taken at baseline and at 24- and 34-weeks' gestation. Multivariable regression analysis determined if temporal differences in 24-h glucose profiles occurred between comparators in each of the three groups.
RESULTS


FDA revealed that women using RT-CGM had significantly lower glucose (0.4-0.8 mmol/L [7-14 mg/dL]) for 7 h/day (0800 h to 1200 h and 1600 h to 1900 h) compared with those with SMBG. Women using pumps had significantly higher glucose (0.4-0.9 mmol/L [7-16 mg/dL]) for 12 h/day (0300 h to 0600 h, 1300 h to 1800 h, and 2030 h to 0030 h) at 24 weeks with no difference at 34 weeks compared with MDI. Women who had an LGA infant ran a significantly higher glucose by 0.4-0.7 mmol/L (7-13 mg/dL) for 4.5 h/day at baseline, by 0.4-0.9 mmol/L (7-16 mg/dL) for 16 h/day at 24 weeks, and by 0.4-0.7 mmol/L (7-13 mg/dL) for 14 h/day at 34 weeks.
CONCLUSIONS


FDA of temporal glucose profiles gives important information about differences in glucose control and its timing, which are undetectable by standard summary metrics. Women using RT-CGM were able to achieve better daytime glucose control, reducing fetal exposure to maternal glucose.",2020,"Multivariable regression analysis determined if temporal differences in 24-h glucose profiles occurred between comparators in each of the three groups.
","['temporal glucose profiles differed between  1 ) women who were randomized to', 'Women who had an LGA infant ran a significantly', 'MDIs), and  3 ) women whose infants were born large for gestational age (LGA) or not, by assessing CGM data obtained from the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT', 'Pregnancy']","['real-time continuous glucose monitoring (RT-CGM) or self-monitored blood glucose (SMBG),  2 ) women who used insulin pumps or multiple daily insulin injections']","['higher glucose', 'daytime glucose control, reducing fetal exposure to maternal glucose', '24-h glucose profiles']","[{'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1848395', 'cui_str': 'Large for gestational age'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0586328', 'cui_str': 'Insulin injection'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",2.0,0.024243,"Multivariable regression analysis determined if temporal differences in 24-h glucose profiles occurred between comparators in each of the three groups.
","[{'ForeName': 'Eleanor M', 'Initials': 'EM', 'LastName': 'Scott', 'Affiliation': 'Department of Clinical and Population Science, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, U.K. e.m.scott@leeds.ac.uk.'}, {'ForeName': 'Denice S', 'Initials': 'DS', 'LastName': 'Feig', 'Affiliation': 'Department of Medicine, Sinai Health System, Toronto, Ontario, Canada.'}, {'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Murphy', 'Affiliation': ""Division of Maternal Health, St Thomas' Hospital, King's College London, London, U.K.""}, {'ForeName': 'Graham R', 'Initials': 'GR', 'LastName': 'Law', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-2527']
881,32211977,Correlations Between Serum Decoy Receptor 3 and Airflow Limitation and Quality of Life in Male Patients with Stable Stage and Acute Exacerbation of COPD.,"PURPOSE


Serum decoy receptor 3 (DcR3) level increases in chronic inflammatory diseases. The present study aimed to examine serum DcR3 and IL-6 levels in male patients with stable chronic obstructive pulmonary disease (COPD) and acute exacerbation of the disease and correlations between these markers and airflow limitation.
METHODS


We measured serum DcR3 and IL-6 levels in 60 COPD patients [30 stable COPD (SCOPD), and 30 acute exacerbation of COPD (AECOPD)], and 30 control subjects and assessed their correlations with airflow limitation according to the COPD stage indicated by the global initiative for chronic obstructive pulmonary disease (GOLD) criteria, peripheral O 2  saturation (SpO 2 ), and COPD assessment test (CAT) score. We also tested associations between serum DcR3 levels and COPD patients' clinical parameters.
RESULTS


Both serum DcR3 and IL-6 levels increased with increasing severity of airflow limitation in SCOPD and AECOPD groups (P < 0.01 to 0.001). These markers also increased in patients with AECOPD compared with subjects in SCOPD group in GOLD stages III-IV (P < 0.05 to 0.001). In addition, there was a significant positive correlation between serum DcR3 level and IL-6, CAT score and smoking history (per year).
CONCLUSION


The study revealed that serum DcR3 level elevated with increasing severity of airflow limitation in male COPD patients, particularly in acute exacerbation phase. This increase was associated with a reduced quality of life and increased severity of hypoxia. These results suggest that DcR3 may be associated with the underlying pathophysiology of COPD in male patients.",2020,Both serum DcR3 and IL-6 levels increased with increasing severity of airflow limitation in SCOPD and AECOPD groups (P < 0.01 to 0.001).,"['Male Patients with Stable Stage and Acute Exacerbation of COPD', 'male patients', 'chronic inflammatory diseases', '60 COPD patients [30 stable COPD (SCOPD), and 30 acute exacerbation of COPD (AECOPD)], and 30 control subjects and assessed their correlations with airflow limitation according to the COPD stage indicated by the', 'male COPD patients', 'male patients with stable chronic obstructive pulmonary disease (COPD']",[],"['Serum Decoy Receptor 3 and Airflow Limitation and Quality of Life', 'global initiative for chronic obstructive pulmonary disease (GOLD) criteria, peripheral O 2  saturation (SpO 2 ), and COPD assessment test (CAT) score', 'serum DcR3 level and IL-6, CAT score and smoking history (per year', 'serum DcR3 level', 'serum DcR3 levels', 'serum DcR3 and IL-6 levels', 'quality of life and increased severity of hypoxia']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C1290886', 'cui_str': 'Chronic inflammatory disorder'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]",60.0,0.0382817,Both serum DcR3 and IL-6 levels increased with increasing severity of airflow limitation in SCOPD and AECOPD groups (P < 0.01 to 0.001).,"[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Ghobadi', 'Affiliation': 'Internal Medicine Department (Pulmonary Division), Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Hosseini', 'Affiliation': 'Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Aslani', 'Affiliation': 'Lung Inflammatory Diseases Research Center, Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran. mraslani105@yahoo.com.'}]",Lung,['10.1007/s00408-020-00348-z']
882,30343620,Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in Patients With Resected  BRAF  V600-Mutant Stage III Melanoma.,"PURPOSE


Dabrafenib plus trametinib improved relapse-free survival (RFS) versus placebo (hazard ratio [HR], 0.47;  P  < .001) in patients with resected  BRAF  V600-mutant stage III melanoma (BRF115532; COMBI-AD; ClinicalTrials.gov identifier: NCT01682083). We present an updated RFS analysis on the basis of extended study follow-up and a cure-rate model analysis to estimate the fraction of patients expected to remain relapse free long term.
METHODS


In this phase III trial, patients with resected  BRAF  V600-mutant stage III melanoma were randomly assigned to 12 months of adjuvant dabrafenib plus trametinib versus placebo. We report updated RFS (primary end point) and distant metastasis-free survival. RFS was also analyzed by subgroups defined by baseline disease stage (American Joint Committee on Cancer 7th and 8th editions), nodal metastatic burden, and ulceration status. The fraction of patients who remained relapse free long term was estimated using a Weibull mixture cure-rate model.
RESULTS


At median follow-up of 44 months (dabrafenib plus trametinib) and 42 months (placebo), 3- and 4-year RFS rates were 59% (95% CI, 55% to 64%) and 54% (95% CI, 49% to 59%) in the dabrafenib plus trametinib arm and 40% (95% CI, 35% to 45%) and 38% (95% CI, 34% to 44%) in the placebo arm, respectively (HR, 0.49; 95% CI, 0.40 to 0.59). Distant metastasis-free survival also favored dabrafenib plus trametinib (HR, 0.53; 95% CI, 0.42 to 0.67). The estimated cure rate was 54% (95% CI, 49% to 59%) in the dabrafenib plus trametinib arm compared with 37% (95% CI, 32% to 42%) in the placebo arm. Subgroup analysis of RFS demonstrated similar treatment benefit regardless of baseline factors, including disease stage, nodal metastatic burden, and ulceration.
CONCLUSION


Longer follow-up confirmed RFS benefit with dabrafenib plus trametinib. Subgroup analysis suggested that dabrafenib plus trametinib benefited patients regardless of baseline factors.",2018,"The estimated cure rate was 54% (95% CI, 49% to 59%) in the dabrafenib plus trametinib arm compared with 37% (95% CI, 32% to 42%) in the placebo arm.","['patients with resected BRAF V600-mutant stage III melanoma', 'Patients']","['placebo', 'adjuvant dabrafenib plus trametinib versus placebo']","['4-year RFS rates', 'RFS', 'nodal metastatic burden, and ulceration status', 'disease stage, nodal metastatic burden, and ulceration', 'estimated cure rate', 'Distant metastasis-free survival', 'relapse-free survival (RFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3887532', 'cui_str': 'Ulceration (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.776619,"The estimated cure rate was 54% (95% CI, 49% to 59%) in the dabrafenib plus trametinib arm compared with 37% (95% CI, 32% to 42%) in the placebo arm.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Santinami', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Nyakas', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Schachter', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lesimple', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Plummer', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Kohinoor', 'Initials': 'K', 'LastName': 'Dasgupta', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Haas', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Shilkrut', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kefford', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy; Victoria Atkinson, Princess Alexandra Hospital; Gallipoli Medical Research Foundation; University of Queensland, Brisbane, Queensland; Andrew Haydon, The Alfred Hospital, Melbourne, Victoria; Richard Kefford, Macquarie University; Westmead Hospital; Richard Kefford and Georgina V. Long, Melanoma Institute Australia; University of Sydney; Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia; James Larkin, Royal Marsden National Health Service Foundation Trust, London; Ruth Plummer, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom; Marta Nyakas, Oslo University Hospital, Oslo, Norway; Caroline Dutriaux, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux; Caroline Robert, Institute Gustave Roussy, Paris; Laurent Mortier, Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Centre Hospitalier Universitaire de sa Region Lille, Lille; Thierry Lesimple, Centre Eugène Marquis, Rennes, France; Jacob Schachter, Sheba Medical Center, Tel Hashomer; Tel Aviv University, Tel Aviv, Israel; Kohinoor Dasgupta, Novartis Healthcare, Hyderabad, India; Mark Shilkrut and Eduard Gasal, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and John M. Kirkwood, UPMC Hillman Cancer Center; University of Pittsburgh, Pittsburgh, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01219']
883,31339827,Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial.,"PURPOSE


Older women with breast cancer remain under-represented in clinical trials. The Cancer and Leukemia Group B 49907 trial focused on women age 65 years and older. We previously reported the primary analysis after a median follow-up of 2.4 years. Standard adjuvant chemotherapy showed significant improvements in recurrence-free survival (RFS) and overall survival compared with capecitabine. We now update results at a median follow-up of 11.4 years.
PATIENTS AND METHODS


Patients age 65 years or older with early breast cancer were randomly assigned to either standard adjuvant chemotherapy (physician's choice of either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide and doxorubicin) or capecitabine. An adaptive Bayesian design was used to determine sample size and test noninferiority of capecitabine. The primary end point was RFS.
RESULTS


The design stopped accrual with 633 patients at its first sample size assessment. RFS remains significantly longer for patients treated with standard chemotherapy. At 10 years, in patients treated with standard chemotherapy versus capecitabine, the RFS rates were 56% and 50%, respectively (hazard ratio [HR], 0.80;  P  = .03); breast cancer-specific survival rates were 88% and 82%, respectively (HR, 0.62;  P  = .03); and overall survival rates were 62% and 56%, respectively (HR, 0.84;  P  = .16). With longer follow-up, standard chemotherapy remains superior to capecitabine among hormone receptor-negative patients (HR, 0.66;  P  = .02), but not among hormone receptor-positive patients (HR, 0.89;  P  = .43). Overall, 43.9% of patients have died (13.1% from breast cancer, 16.4% from causes other than breast cancer, and 14.1% from unknown causes). Second nonbreast cancers occurred in 14.1% of patients.
CONCLUSION


With longer follow-up, RFS remains superior for standard adjuvant chemotherapy versus capecitabine, especially in patients with hormone receptor-negative disease. Competing risks in this older population dilute overall survival benefits.",2019,Standard adjuvant chemotherapy showed significant improvements in recurrence-free survival (RFS) and overall survival compared with capecitabine.,"['Older women with breast cancer remain under-represented in clinical trials', 'Older Women With Early Breast Cancer', 'patients with hormone receptor-negative disease', 'women age 65 years and older', '633 patients at its first sample size assessment', 'Patients age 65 years or older with early breast cancer']","['capecitabine', 'standard chemotherapy', 'Standard Adjuvant Chemotherapy Regimens Versus Capecitabine', ""standard adjuvant chemotherapy (physician's choice of either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide and doxorubicin) or capecitabine"", 'standard chemotherapy versus capecitabine']","['overall survival rates', 'RFS', 'recurrence-free survival (RFS) and overall survival', 'died', 'RFS rates', 'breast cancer-specific survival rates']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",633.0,0.250812,Standard adjuvant chemotherapy showed significant improvements in recurrence-free survival (RFS) and overall survival compared with capecitabine.,"[{'ForeName': 'Hyman B', 'Initials': 'HB', 'LastName': 'Muss', 'Affiliation': 'University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Mei-Yin C', 'Initials': 'MC', 'LastName': 'Polley', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Berry', 'Affiliation': 'Alliance Statistics and Data Center, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Constance T', 'Initials': 'CT', 'LastName': 'Cirrincione', 'Affiliation': 'Robert H Lurie Comprehensive Cancer Center, Northwestern University, Evanston, IL.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Theodoulou', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Mauer', 'Affiliation': 'Advocate Illinois Masonic Medical Center, Chicago, IL.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Kornblith', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Advocate Illinois Masonic Medical Center, Chicago, IL.'}, {'ForeName': 'Lynn G', 'Initials': 'LG', 'LastName': 'Dressler', 'Affiliation': 'University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Kartcheske', 'Affiliation': 'Robert H Lurie Comprehensive Cancer Center, Northwestern University, Evanston, IL.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Sidney Kimmel Cancer Center, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'University of Washington Seattle Cancer Alliance, Seattle, WA.'}, {'ForeName': 'Harold J', 'Initials': 'HJ', 'LastName': 'Burstein', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Mahmood', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Sutton', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, NC.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Magrinat', 'Affiliation': 'Cone Health Cancer Center, Greensboro, NC.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Parker', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Hart', 'Affiliation': 'Harold Alfond Center for Cancer Care, Augusta, ME.'}, {'ForeName': 'Debjani', 'Initials': 'D', 'LastName': 'Grenier', 'Affiliation': 'St Boniface General Hospital, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Arti', 'Initials': 'A', 'LastName': 'Hurria', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, CA.'}, {'ForeName': 'Aminah', 'Initials': 'A', 'LastName': 'Jatoi', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Norton', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Clifford A', 'Initials': 'CA', 'LastName': 'Hudis', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Carey', 'Affiliation': 'University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00647']
884,32201572,"Protocol for the Effectiveness of an Anesthesiology Control Tower System in Improving Perioperative Quality Metrics and Clinical Outcomes: the TECTONICS randomized, pragmatic trial.","Introduction:  Perioperative morbidity is a public health priority, and surgical volume is increasing rapidly. With advances in technology, there is an opportunity to research the utility of a telemedicine-based control center for anesthesia clinicians that assess risk, diagnoses negative patient trajectories, and implements evidence-based practices.  Objectives:  The primary objective of this trial is to determine whether an anesthesiology control tower (ACT) prevents clinically relevant adverse postoperative outcomes including 30-day mortality, delirium, respiratory failure, and acute kidney injury. Secondary objectives are to determine whether the ACT improves perioperative quality of care metrics including management of temperature, mean arterial pressure, mean airway pressure with mechanical ventilation, blood glucose, anesthetic concentration, antibiotic redosing, and efficient fresh gas flow.  Methods and analysis:  We are conducting a single center, randomized, controlled, phase 3 pragmatic clinical trial. A total of 58 operating rooms are randomized daily to receive support from the ACT or not. All adults (eighteen years and older) undergoing surgical procedures in these operating rooms are included and followed until 30 days after their surgery. Clinicians in operating rooms randomized to ACT support receive decision support from clinicians in the ACT. In operating rooms randomized to no intervention, the current standard of anesthesia care is delivered. The intention-to-treat principle will be followed for all analyses. Differences between groups will be presented with 99% confidence intervals; p-values <0.005 will be reported as providing compelling evidence, and p-values between 0.05 and 0.005 will be reported as providing suggestive evidence.  Registration:  TECTONICS is registered on ClinicalTrials.gov,  NCT03923699 ; registered on 23 April 2019.",2019,"With advances in technology, there is an opportunity to research the utility of a telemedicine-based control center for anesthesia clinicians that assess risk, diagnoses negative patient trajectories, and implements evidence-based practices.  ",['All adults (eighteen years and older) undergoing surgical procedures in these operating rooms are included and followed until 30 days after their surgery'],"['anesthesiology control tower (ACT', 'Anesthesiology Control Tower System', 'ACT']","['Perioperative Quality Metrics and Clinical Outcomes', 'perioperative quality of care metrics including management of temperature, mean arterial pressure, mean airway pressure with mechanical ventilation, blood glucose, anesthetic concentration, antibiotic redosing, and efficient fresh gas flow', '30-day mortality, delirium, respiratory failure, and acute kidney injury']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0442799', 'cui_str': 'Efficient (qualifier value)'}, {'cui': 'C0428716', 'cui_str': 'Fresh gas flow (observable entity)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}]",,0.307689,"With advances in technology, there is an opportunity to research the utility of a telemedicine-based control center for anesthesia clinicians that assess risk, diagnoses negative patient trajectories, and implements evidence-based practices.  ","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'King', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Abraham', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Kannampallil', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Fritz', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Arbi', 'Initials': 'A', 'LastName': 'Ben Abdallah', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Computer Science and Engineering, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Henrichs', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Politi', 'Affiliation': 'Department of Surgery, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Torres', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Mickle', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Thaddeus P', 'Initials': 'TP', 'LastName': 'Budelier', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'McKinnon', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gregory', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Kheterpal', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Wildes', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': 'Department of Anesthesiology, Washington University in St Louis, St Louis, MO, 63110, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",F1000Research,['10.12688/f1000research.21016.1']
885,30395144,Pilot randomized trial of an electronic symptom monitoring intervention for hospitalized patients with cancer.,"BACKGROUND


Hospitalized patients with cancer experience a high symptom burden, which is associated with poor health outcomes and increased health care utilization. However, studies investigating symptom monitoring interventions in this population are lacking. We conducted a pilot randomized trial to assess the feasibility and preliminary efficacy of a symptom monitoring intervention to improve symptom management in hospitalized patients with advanced cancer.
PATIENTS AND METHODS


We randomly assigned patients with advanced cancer who were admitted to the inpatient oncology service to a symptom monitoring intervention or usual care. Patients in both arms self-reported their symptoms daily (Edmonton Symptom Assessment System and Patient Health Questionnaire-4). Patients assigned to the intervention had their symptom reports presented graphically with alerts for moderate/severe symptoms during daily team rounds. The primary end point of the study was feasibility. We defined the intervention as feasible if >75% of participants hospitalized >2 days completed >2 symptom reports. We observed daily rounds to determine whether clinicians discussed and developed a plan to address patients' symptoms. We used regression models to assess intervention effects on patients' symptoms throughout their hospitalization, readmission risk, and hospital length of stay (LOS).
RESULTS


Among 150 enrolled patients (81.1% enrollment), 94.2% completed >2 symptom reports. Clinicians discussed 60.4% of the symptom reports and developed a plan to address the symptoms highlighted by the symptom reports 20.8% of the time. Compared with usual care, intervention patients had a greater proportion of days with lower psychological distress (B = 0.12, P = 0.008), but no significant difference in the proportion of days with improved Edmonton Symptom Assessment System-physical symptoms (B = 0.07, P = 0.138). Intervention patients had lower readmission risk (hazard ratio = 0.68, P = 0.224), although this difference was not significant. We found no significant intervention effects on hospital LOS (B = 0.16, P = 0.862).
CONCLUSIONS


This symptom monitoring intervention is feasible and demonstrates encouraging preliminary efficacy for improving patients' symptoms and readmission risk.ClinicalTrials.gov identifier NCT02891993.",2019,"Compared with usual care, intervention patients had a greater proportion of days with lower psychological distress (B = 0.12, P = 0.008), but no significant difference in the proportion of days with improved Edmonton Symptom Assessment System-physical symptoms (B = 0.07, P = 0.138).","['Hospitalized patients with cancer experience a high symptom burden', 'hospitalized patients with advanced cancer', 'hospitalized patients with cancer', '150 enrolled patients (81.1% enrollment), 94.2% completed >2 symptom reports', 'We randomly assigned patients with advanced cancer who were admitted to the inpatient oncology service to a symptom monitoring intervention or usual care']","['symptom monitoring intervention', 'electronic symptom monitoring intervention']","['hospitalization, readmission risk, and hospital length of stay (LOS', 'lower readmission risk', 'hospital LOS', 'proportion of days with improved Edmonton Symptom Assessment System-physical symptoms', 'symptoms daily (Edmonton Symptom Assessment System and Patient Health Questionnaire-4', 'proportion of days with lower psychological distress']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3472649', 'cui_str': 'ESAS'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",150.0,0.0364236,"Compared with usual care, intervention patients had a greater proportion of days with lower psychological distress (B = 0.12, P = 0.008), but no significant difference in the proportion of days with improved Edmonton Symptom Assessment System-physical symptoms (B = 0.07, P = 0.138).","[{'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Nipp', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital & Harvard Medical School, Boston, USA. Electronic address: rnipp@mgh.harvard.edu.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fuh', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Temel', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': ""D'Arpino"", 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Cashavelly', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Jackson', 'Affiliation': 'Division of Palliative Care, Department of Medicine, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Ryan', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Hochberg', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdy488']
886,30428063,"Paclitaxel with or without trametinib or pazopanib in advanced wild-type BRAF melanoma (PACMEL): a multicentre, open-label, randomised, controlled phase II trial.","BACKGROUND


Advanced melanoma treatments often rely on immunotherapy or targeting mutations, with few treatment options for wild-type BRAF (BRAF-wt) melanoma. However, the mitogen-activated protein kinase pathway is activated in most melanoma, including BRAF-wt. We assessed whether inhibiting this pathway by adding kinase inhibitors trametinib or pazopanib to paclitaxel chemotherapy improved outcomes in patients with advanced BRAF-wt melanoma in a phase II, randomised and open-label trial.
PATIENTS AND METHODS


Patients were randomised (1 : 1 : 1) to paclitaxel alone or with trametinib or pazopanib. Paclitaxel was given for a maximum of six cycles, while 2 mg trametinib and 800 mg pazopanib were administered orally once daily until disease progression or unacceptable toxicity. Participants and investigators were unblinded. The primary end point was progression-free survival (PFS). Key secondary end points included overall survival (OS) and objective response rate (ORR).
RESULTS


Participants were randomised to paclitaxel alone (n = 38), paclitaxel and trametinib (n = 36), or paclitaxel and pazopanib (n = 37). Adding trametinib significantly improved 6-month PFS [time ratio (TR), 1.47; 90% confidence interval (CI) 1.08-2.01, P = 0.04] and ORR (42% versus 13%; P = 0.01) but had no effect on OS (P = 0.25). Adding pazopanib did not benefit 6-month PFS; (TR 1.36; 90% CI 0.96-1.93; P = 0.14), ORR, or OS. Toxicity increased in both combination arms.
CONCLUSION


In this phase II trial, adding trametinib to paclitaxel chemotherapy for BRAF-wt melanoma improved PFS and substantially increased ORR but did not impact OS.This study was registered with the EU Clinical Trials Register, EudraCT number 2011-002545-35, and with the ISRCTN registry, number 43327231.",2019,"Adding trametinib significantly improved 6-month PFS [time ratio (TR), 1.47; 90% confidence interval (CI) 1.08-2.01, P = 0.04] and ORR (42% versus 13%; P = 0.01) but had no effect on OS (P = 0.25).","['patients with advanced BRAF-wt melanoma in a phase II, randomised and open-label trial', 'Patients were randomised ', 'advanced wild-type BRAF melanoma (PACMEL']","['paclitaxel and pazopanib', 'paclitaxel and trametinib', 'Paclitaxel', 'paclitaxel alone or with trametinib or pazopanib', '1\xa0:\xa01\xa0', 'paclitaxel alone', 'pazopanib', 'pazopanib to paclitaxel chemotherapy', 'Paclitaxel with or without trametinib or pazopanib']","['progression-free survival (PFS', '6-month PFS [time ratio (TR', 'Toxicity', 'overall survival (OS) and objective response rate (ORR', 'ORR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1264675', 'cui_str': 'Time ratio'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",,0.550047,"Adding trametinib significantly improved 6-month PFS [time ratio (TR), 1.47; 90% confidence interval (CI) 1.08-2.01, P = 0.04] and ORR (42% versus 13%; P = 0.01) but had no effect on OS (P = 0.25).","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Urbonas', 'Affiliation': 'Early Phase Clinical Trials Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, UK; National Cancer Institute, Vilnius, Lithuania.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, West German Cancer Centre, University Duisburg-Essen, Essen, Germany; The German Cancer Consortium, Essen, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zimmer', 'Affiliation': 'Department of Dermatology, University Hospital Essen, West German Cancer Centre, University Duisburg-Essen, Essen, Germany; The German Cancer Consortium, Essen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Danson', 'Affiliation': 'Department of Oncology, Sheffield Experimental Cancer Medicine Centre, Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Marshall', 'Affiliation': 'Department of Oncology, Clatterbridge Cancer Centre, Wirral, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Corrie', 'Affiliation': 'Department of Oncology, Addenbrookes Hospital, Cambridge, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wheater', 'Affiliation': 'Department of Oncology, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Plummer', 'Affiliation': 'Department of Oncology, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mauch', 'Affiliation': 'Köln Universitätsklinik, Köln, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Scudder', 'Affiliation': 'Oncology Clinical Trials Office, University of Oxford, Oxford, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Goff', 'Affiliation': 'Oncology Clinical Trials Office, University of Oxford, Oxford, UK.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Love', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Mohammed', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'Early Phase Clinical Trials Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Department of Oncology, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK. Electronic address: mark.middleton@oncology.ox.ac.uk.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdy500']
887,30657853,Use of archival versus newly collected tumor samples for assessing PD-L1 expression and overall survival: an updated analysis of KEYNOTE-010 trial.,"BACKGROUND


In KEYNOTE-010, pembrolizumab versus docetaxel improved overall survival (OS) in patients with programmed death-1 protein (PD)-L1-positive advanced non-small-cell lung cancer (NSCLC). A prespecified exploratory analysis compared outcomes in patients based on PD-L1 expression in archival versus newly collected tumor samples using recently updated survival data.
PATIENTS AND METHODS


PD-L1 was assessed centrally by immunohistochemistry (22C3 antibody) in archival or newly collected tumor samples. Patients received pembrolizumab 2 or 10 mg/kg Q3W or docetaxel 75 mg/m2 Q3W for 24 months or until progression/intolerable toxicity/other reason. Response was assessed by RECIST v1.1 every 9 weeks, survival every 2 months. Primary end points were OS and progression-free survival (PFS) in tumor proportion score (TPS) ≥50% and ≥1%; pembrolizumab doses were pooled in this analysis.
RESULTS


At date cut-off of 24 March 2017, median follow-up was 31 months (range 23-41) representing 18 additional months of follow-up from the primary analysis. Pembrolizumab versus docetaxel continued to improve OS in patients with previously treated, PD-L1-expressing advanced NSCLC; hazard ratio (HR) was 0.66 [95% confidence interval (CI): 0.57, 0.77]. Of 1033 patients analyzed, 455(44%) were enrolled based on archival samples and 578 (56%) on newly collected tumor samples. Approximately 40% of archival samples and 45% of newly collected tumor samples were PD-L1 TPS ≥50%. For TPS ≥50%, the OS HRs were 0.64 (95% CI: 0.45, 0.91) and 0.40 (95% CI: 0.28, 0.56) for archival and newly collected samples, respectively. In patients with TPS ≥1%, OS HRs were 0.74 (95% CI: 0.59, 0.93) and 0.59 (95% CI: 0.48, 0.73) for archival and newly collected samples, respectively. In TPS ≥50%, PFS HRs were similar across archival [0.63 (95% CI: 0.45, 0.89)] and newly collected samples [0.53 (95% CI: 0.38, 0.72)]. In patients with TPS ≥1%, PFS HRs were similar across archival [0.82 (95% CI: 0.66, 1.02)] and newly collected samples [0.83 (95% CI: 0.68, 1.02)].
CONCLUSION


Pembrolizumab continued to improve OS over docetaxel in intention to treat population and in subsets of patients with newly collected and archival samples.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01905657.",2019,"For TPS ≥50%, the OS HRs were 0.64 (95% CI: 0.45, 0.91) and 0.40 (95% CI: 0.28, 0.56) for archival and newly collected samples, respectively.","['1033 patients analyzed, 455(44%) were enrolled based on archival samples and 578 (56%) on newly collected tumor samples', 'PD-L1 was assessed centrally by immunohistochemistry (22C3 antibody) in archival or newly collected tumor samples', 'patients with programmed death-1 protein (PD)-L1-positive advanced non-small-cell lung cancer (NSCLC']","['pembrolizumab versus docetaxel', 'docetaxel', 'Pembrolizumab', 'Pembrolizumab versus docetaxel', 'pembrolizumab 2 or 10\u2009mg/kg Q3W or docetaxel 75\u2009mg/m2 Q3W']","['overall survival (OS', 'PFS HRs', 'OS and progression-free survival (PFS) in tumor proportion score (TPS', 'PD-L1 expression and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.425069,"For TPS ≥50%, the OS HRs were 0.64 (95% CI: 0.45, 0.91) and 0.40 (95% CI: 0.28, 0.56) for archival and newly collected samples, respectively.","[{'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': 'Department of Medical Oncology, Yale University School of Medicine, Yale Comprehensive Cancer Center, New Haven, USA. Electronic address: roy.herbst@yale.edu.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Baas', 'Affiliation': 'Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Perez-Gracia', 'Affiliation': 'Department of Oncology, Clinica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Lung Cancer Unit, Department of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain; Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'D-W', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'Division of Translational & Clinical Research, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Molina', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, USA.'}, {'ForeName': 'J-H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Medical Oncology, CHA Bundang Medical Center, CHA University, Gyeonggi-Do, Republic of Korea.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dubos Arvis', 'Affiliation': 'Department of Medicine, Centre François Baclesse, Caen, France.'}, {'ForeName': 'M-J', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Fidler', 'Affiliation': 'Division of Hematology Oncology, Rush University Medical Center, Chicago, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Surmont', 'Affiliation': 'Department of Respiratory Medicine/Thoracic Oncology, Universitar Ziekenhuis Ghent, Ghent, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'de Castro', 'Affiliation': 'Department of Medical Oncology, Instituto do Câncer do Estado de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Garrido', 'Affiliation': 'Department of Hemato-Oncology, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shentu', 'Affiliation': 'Department of Clinical Research, Merck & Co. Inc., Kenilworth, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Emancipator', 'Affiliation': 'Department of Clinical Research, Merck & Co. Inc., Kenilworth, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Samkari', 'Affiliation': 'Department of Clinical Research, Merck & Co. Inc., Kenilworth, USA.'}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Research, Merck & Co. Inc., Kenilworth, USA.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Lubiniecki', 'Affiliation': 'Department of Clinical Research, Merck & Co. Inc., Kenilworth, USA.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdy545']
888,30732732,Pulmonary Artery Denervation Significantly Increases 6-Min Walk Distance for Patients With Combined Pre- and Post-Capillary Pulmonary Hypertension Associated With Left Heart Failure: The PADN-5 Study.,"OBJECTIVES


The authors sought to assess the benefits of pulmonary artery denervation (PADN) among combined pre- and post-capillary pulmonary hypertension (CpcPH) patients in a prospective, randomized, sham-controlled trial.
BACKGROUND


PADN has been shown to improve hemodynamics of pulmonary arterial hypertension in a series of patients. Additionally, benefits of targeted medical therapy for patients with CpcPH secondary to left-sided heart failure are unknown.
METHODS


Ninety-eight CpcPH patients, defined as mean pulmonary arterial pressure ≥25 mm Hg, pulmonary capillary wedge pressure >15 mm Hg, and pulmonary vascular resistance (PVR) >3.0 Wood units (WU), were randomly assigned to PADN or sildenafil plus sham PADN. Standard medical therapy for heart failure was administered to all patients in both groups. The primary endpoint was the increase in the 6-min walk distance at the 6-month follow-up. The secondary endpoint was change in PVR. Clinical worsening was assessed in a post hoc analysis. The main safety endpoint was occurrence of pulmonary embolism.
RESULTS


At 6 months, the mean increases in the 6-min walk distance were 83 m in the PADN group and 15 m in the sildenafil group (least square mean difference 66 m, 95% confidence interval: 38.2 to 98.8 m; p < 0.001). PADN treatment was associated with a significantly lower PVR than in the sildenafil group (4.2 ± 1.5 WU vs. 6.1 ± 2.9 WU; p = 0.001). Clinical worsening was less frequent in the PADN group compared with the sildenafil group (16.7% vs. 40%; p = 0.014). At the end of the study, there were 7 all-cause deaths and 2 cases of pulmonary embolism.
CONCLUSIONS


PADN is associated with significant improvements in hemodynamic and clinical outcomes in patients with CpcPH. Further studies are warranted to define its precise role in the treatment of this patient population. (Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure [PADN-5]; NCT02220335).",2019,Clinical worsening was less frequent in the PADN group compared with the sildenafil group (16.7% vs. 40%; p = 0.014).,"['patients with CpcPH secondary to left-sided heart failure', 'Failure', 'Patients With Pulmonary Hypertension', 'Ninety-eight', 'Patients With Combined Pre- and', 'patients with CpcPH']","['combined pre- and post-capillary pulmonary hypertension (CpcPH', 'sildenafil', 'PADN or sildenafil plus sham PADN', 'pulmonary artery denervation (PADN', 'CpcPH']","['Hg, pulmonary capillary wedge pressure', '6-min walk distance', 'pulmonary embolism', '6-Min Walk Distance', 'change in PVR', 'mean pulmonary arterial pressure', 'hemodynamic and clinical outcomes', 'pulmonary vascular resistance (PVR', 'occurrence of pulmonary embolism', 'mean increases in the 6-min walk distance', 'PVR', 'Clinical worsening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0023212', 'cui_str': 'Left-Sided Heart Failure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1283386', 'cui_str': 'Post-capillary pulmonary hypertension (disorder)'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary Artery'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}]","[{'cui': 'C0086879', 'cui_str': 'Pulmonary Capillary Wedge Pressure'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3854605', 'cui_str': 'Mean pulmonary arterial pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",98.0,0.113782,Clinical worsening was less frequent in the PADN group compared with the sildenafil group (16.7% vs. 40%; p = 0.014).,"[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Mengxuan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Mailman School of Health, Columbia University, New York, New York.'}, {'ForeName': 'Du-Jiang', 'Initials': 'DJ', 'LastName': 'Xie', 'Affiliation': 'Division of Cardiology, Nanjing Cardiovascular Hospital, Nanjing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Kan', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Wande', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Division of Cardiology, Nanjing Cardiovascular Hospital, Nanjing, China.'}, {'ForeName': 'Xiao-Bo', 'Initials': 'XB', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Nanjing Cardiovascular Hospital, Nanjing, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Division of Cardiology, Nanjing Cardiovascular Hospital, Nanjing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jianzeng', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Division of Pulmonology, Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Division of Pulmonology, Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Division of Cardiology, Shenyang Northern Hospital, Shenyang, China.'}, {'ForeName': 'Shao-Liang', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. Electronic address: chmengx@126.com.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2018.09.021']
889,32209529,Help to Overcome Problems Effectively for Cancer Survivors: Development and Evaluation of a Digital Self-Management Program.,"BACKGROUND


People living with cancer face numerous psychosocial challenges, including cancer-related fatigue, fear of recurrence, and depression. There is a lack of digital interventions tailored to the needs of people living with all types of cancer. We developed a 6-week, digital, peer-delivered, self-management program: iHOPE (Help to Overcome Problems Effectively; where 'i' indicates the digital version of the program). The program is underpinned by positive psychology and cognitive behavioral therapy to meet these psychosocial challenges.
OBJECTIVE


This study aimed to assess the feasibility of the iHOPE program among people living with cancer. Program adherence and satisfaction along with changes in psychological distress and positive well-being were measured.
METHODS


A pre-post, acceptability, and feasibility design was used. People living with cancer (N=114) were recruited via a national cancer charity in the United Kingdom and were given access to the iHOPE program. Demographic and other participant characteristics were recorded. Participants completed digital measures at baseline and the end of the 6-week program for depression, anxiety, cancer-related fatigue, cancer worry or fear of cancer recurrence, positive mental well-being, hope, gratitude, and health status. The website's system recorded data on the usage of the program. Satisfaction with the program was also measured.
RESULTS


A total of 114 participants completed the baseline questionnaires. Of these, 70 people (61.4%) participated in all 6 sessions. The mean number of sessions undertaken was 5.0 (SD 1.5). Moreover, 44.7% (51/114) of participants completed at least three sessions and end-of-program outcome measures. A total of 59 participants completed the satisfaction questionnaire, where ≥90% (54/58) of participants reported that the program was easy to navigate and was well managed by the peer facilitators, and that they found the social networking tools useful. Preliminary efficacy testing among the 51 participants who completed baseline and postprogram outcome measures showed that postprogram scores decreased for depression, anxiety, cancer-related fatigue, and fear of recurrence (all P<.001) and increased for positive mental well-being (P<.001), hope (both P<.001), and gratitude (P=.02).
CONCLUSIONS


The feasibility evidence is promising, showing that the peer-delivered digital iHOPE program is acceptable and practical. Implementation of the iHOPE program on a wider scale will incorporate further research and development to maximize the completion rates of the measures. Initial effectiveness data suggest positive impacts on important cancer-related quality of life and mental well-being outcomes. A randomized controlled trial design with a longer follow-up is needed to confirm the potential of the iHOPE program for improving mental and physical health outcomes for cancer survivors.",2020,"Preliminary efficacy testing among the 51 participants who completed baseline and post-programme outcome measures showed that post-programme scores decreased for depression, anxiety, cancer related fatigue and fear of recurrence (all P<.001) and increased for positive mental wellbeing, hope (both P<.001) and gratitude (P=0.015).
","['cancer survivors', 'Cancer Survivors', 'Seventy people (61%) participated in all six sessions', 'people living with cancer', 'People living with cancer (n=114) were recruited via a national cancer charity in the United Kingdom and were given access to the iHOPE programme', 'One hundred and fourteen participants completed baseline questionnaires']",['iHOPE programme'],"['depression, anxiety, cancer-related fatigue, cancer ""worry"" or fear of cancer recurrence, positive mental wellbeing, hope, gratitude and health status', 'important cancer-related quality of life and mental wellbeing outcomes', 'satisfaction questionnaire', 'psychological distress and positive wellbeing', 'depression, anxiety, cancer related fatigue and fear of recurrence', 'mean number of sessions undertaken', 'positive mental wellbeing, hope (both P<.001) and gratitude']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007962', 'cui_str': 'Charities'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}]",114.0,0.12117,"Preliminary efficacy testing among the 51 participants who completed baseline and post-programme outcome measures showed that post-programme scores decreased for depression, anxiety, cancer related fatigue and fear of recurrence (all P<.001) and increased for positive mental wellbeing, hope (both P<.001) and gratitude (P=0.015).
","[{'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Martin', 'Affiliation': 'Faculty of Health and Applied Science, University of the West of England, Bristol, United Kingdom.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Wright', 'Affiliation': 'Faculty Research Centre for Intelligent Healthcare, Faculty of Health and Life Sciences, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Moody', 'Affiliation': 'Faculty Research Centre for Arts, Memory and Communities, Faculty of Arts and Humanities, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Whiteman', 'Affiliation': 'UK Early Cancer Detection Consortium, Faculty of Health and Life Sciences, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McGillion', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Clyne', 'Affiliation': 'Hope for The Community, Community Interest Company, The Enterprise Hub, Coventry, United Kingdom.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Pearce', 'Affiliation': 'Faculty of Health and Life Sciences, School of Psychological, Social and Behavioural Sciences, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Faculty Research Centre for Intelligent Healthcare, Faculty of Health and Life Sciences, Coventry University, Coventry, United Kingdom.'}]",Journal of medical Internet research,['10.2196/17824']
890,32402832,Transrectal Natural Orifice Specimen Extraction (NOSE) With Oncological Safety: A Prospective and Randomized Trial.,"BACKGROUND


In the present paper, we introduce our experience with the novel method during laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE).
METHODS


A prospective randomized controlled trial was performed from June 2016 to May 2019. Patients with upper rectal or sigmoid colon cancer were randomized in a 1:1 ratio to the NOSE group and the non-NOSE group. Preoperative and postoperative clinical variables were analyzed and compared between groups. Postoperative pain was analyzed utilizing a visual analog scale. Postoperative overall survival was analyzed using a Kaplan-Meier curve.
RESULTS


A total of 276 patients were enrolled, of whom 254 were randomly divided into the NOSE group (n = 122) and the conventional laparoscopic group (n = 119). NOSE failed in 22 cases, which were converted to transabdominal specimen extraction. Intention-to-treat analysis was performed, and these 22 cases were included in the NOSE group. The incidence of postoperative complications was significantly lower in the NOSE group (11/122, 9%) than in the non-NOSE group (25/119, 21%). The NOSE group had a longer operation time, less blood loss, and a lower postoperative visual analog scale score than the non-NOSE group. The time for intestinal function recovery (ventilation) and the length of hospital stay were significantly longer in the non-NOSE group. The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
CONCLUSIONS


The novel NOSE method is safe and feasible to use in patients having colorectal cancer. Compared with traditional laparoscopic surgery, the postoperative complication rates of NOSE surgery were lower with an improved short-term clinical recovery.",2020,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
","['June 2016 to May 2019', 'patients having colorectal cancer', '22 cases were included in the NOSE group', 'Patients with upper rectal or sigmoid colon cancer', 'A total of 276 patients were enrolled, of whom 254']","['conventional laparoscopic group', 'traditional laparoscopic surgery', 'laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE', 'Transrectal Natural Orifice Specimen Extraction (NOSE', 'NOSE']","['incidence of postoperative complications', 'longer operation time, less blood loss', 'postoperative complication rates of NOSE surgery', 'time for intestinal function recovery (ventilation) and the length of hospital stay', 'disease-free survival rate', 'postoperative visual analog scale score', 'Postoperative overall survival', 'Postoperative pain']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",276.0,0.0637219,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group.
","[{'ForeName': 'Zhu-Qing', 'Initials': 'ZQ', 'LastName': 'Zhou', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kaijing', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qixin', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chuan-Gang', 'Initials': 'CG', 'LastName': 'Fu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: fugang416@126.com.'}]",The Journal of surgical research,['10.1016/j.jss.2020.03.064']
891,32402931,Long-term outcome of perioperative low cardiac output syndrome in cardiac surgery: 1-year results of a multicenter randomized trial.,"PURPOSE


Perioperative myocardial dysfunction occurs frequently in cardiac surgery, and is a risk factor for morbidity and mortality. Levosimendan has been suggested to reduce mortality of patients with perioperative myocardial dysfunction. However, long-term outcome data on its efficacy in cardiac surgery are lacking.
MATERIALS AND METHODS


Cardiac surgery patients with perioperative myocardial dysfunction were randomized to levosimendan or placebo, in addition to standard inotropic care. One-year mortality data were collected.
RESULTS


We randomized 506 patients (248 to levosimendan 258 to placebo). At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60). Female sex, history of chronic obstructive pulmonary disease, previous myocardial infarction, serum creatinine, hematocrit, mean arterial pressure, and duration of cardiopulmonary bypass were independently associated with 1-year mortality.
CONCLUSIONS


Levosimendan administration does not improve 1-year survival in cardiac surgery patients with perioperative myocardial dysfunction. One-year mortality in these patients is 17%. Six predictive factors for long-term mortality were identified.
STUDY REGISTRATION NUMBER


NCT00994825 (ClinicalTrials.gov).",2020,"At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60).","['Cardiac surgery patients with perioperative myocardial dysfunction', 'cardiac surgery', 'cardiac surgery patients with perioperative myocardial dysfunction', '506 patients (248 to', 'patients with perioperative myocardial dysfunction']","['Levosimendan', 'perioperative low cardiac output syndrome', 'levosimendan', 'levosimendan 258 to placebo', 'levosimendan or placebo']","['Female sex, history of chronic obstructive pulmonary disease, previous myocardial infarction, serum creatinine, hematocrit, mean arterial pressure, and duration of cardiopulmonary bypass', '1-year survival']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340515', 'cui_str': 'Myocardial dysfunction'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0600177', 'cui_str': 'Low cardiac output syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",506.0,0.403453,"At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zangrillo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Vladimir V', 'Initials': 'VV', 'LastName': 'Lomivorotov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia; Novosibirsk State University, Novosibirsk, Russia.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pisano', 'Affiliation': 'Division of Cardiac Anesthesia and Intensive Care Unit, AORN dei Colli - Monaldi Hospital, Naples, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Calabrò', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Belletti', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Brazzi', 'Affiliation': 'Department of Anesthesia, Intensive Care and Emergency, Città della Salute e della Scienza Hospital, Turin, Italy; Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Evgeny V', 'Initials': 'EV', 'LastName': 'Grigoryev', 'Affiliation': 'Intensive Care Unit, Scientific Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russia.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Guarracino', 'Affiliation': 'Division of Cardiothoracic Anesthesia and Intensive Care, Department of Anesthesia and Critical Care Medicine, AOU Pisana, Pisa, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Monaco', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Garofalo', 'Affiliation': 'Department of Anesthesia and Intensive Care, AOU Mater Domini Germaneto, Catanzaro, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Crivellari', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Valery V', 'Initials': 'VV', 'LastName': 'Likhvantsev', 'Affiliation': 'Department of Anesthesiology and Intensive Care, First Moscow State Medical University, Moscow, Russia; V. Negovsky Reanimatology Research Institute, Moscow, Russia.'}, {'ForeName': 'Evgeny V', 'Initials': 'EV', 'LastName': 'Fominskiy', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Paternoster', 'Affiliation': 'Department of Anesthesia and Intensive Care, San Carlo Hospital, Potenza, Italy.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Yavorovskiy', 'Affiliation': 'Department of Anesthesiology and Intensive Care, First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Vadim V', 'Initials': 'VV', 'LastName': 'Pasyuga', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Federal Center for Cardiovascular Surgery Astrakhan, Astrakhan, Russia.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Oriani', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Lembo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Bianchi', 'Affiliation': 'Department of Cardiovascular Anesthesia and Intensive Care, AO Ordine Mauriziano, Turin, Italy.'}, {'ForeName': 'A Mara', 'Initials': 'AM', 'LastName': 'Scandroglio', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Marat N', 'Initials': 'MN', 'LastName': 'Abubakirov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Di Tomasso', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. Electronic address: landoni.giovanni@hsr.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2020.04.005']
892,32402953,The effect of swimming program on body composition levels in adolescents with Down syndrome.,"BACKGROUND


Down syndrome has been associated with more than 80 clinical characteristics such as diabetes, cardiovascular problems or obesity.
AIMS


The current study determined the effect of a 36 weeks swimming program on different indicators of body composition in adolescents with Down syndrome.
METHODS AND PROCEDURES OUTCOMES


45 adolescents with Down syndrome were recruited and randomized to two groups (control group vs. exercise group). Adolescents allocated in the control group carried out a recreational swimming program twice a week during 36 weeks meanwhile adolescents allocated in the exercise group did exercise three time a week during 36 weeks. BMI, Waist circumference, waist-to-height ratio, triceps, subscapular, suprailiac and thigh skinfold were measured.
RESULTS


ANCOVA tests were used to evaluate differences between groups in post-test intervention. Repeated measures of ANOVA were performed in order to assess differences in pre-test intervention in each group. t test were carried out to compare the pre-post-intervention differences in physical characteristics and body composition within each group. The exercise group had significant improvements in all variables of body composition (p < 0.05) except in subscapular and thigh skinfold.
CONCLUSIONS AND IMPLICATIONS


The results suggest that a 36 weeks swimming program consisting of 3 sessions of 50 minutes is able to decrease levels of body composition in a sample of adolescents with Down syndrome. The findings indicate that it would be important to generate high intensity sports programs in sports associations in order to obtain positive impact on body composition levels within this population.",2020,"The exercise group had significant improvements in all variables of body composition (p < 0.05) except in subscapular and thigh skinfold.
","['45 adolescents with Down syndrome', 'adolescents with Down syndrome']","['swimming program', 'recreational swimming program']","['body composition levels', 'body composition', 'levels of body composition', 'BMI, Waist circumference, waist-to-height ratio, triceps, subscapular, suprailiac and thigh skinfold', 'subscapular and thigh skinfold']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}]","[{'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1821269', 'cui_str': 'Waist to Height Ratio'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}]",45.0,0.0627267,"The exercise group had significant improvements in all variables of body composition (p < 0.05) except in subscapular and thigh skinfold.
","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Suarez-Villadat', 'Affiliation': 'Department of Physical Activity and Sport Sciences, Alfonso X el Sabio University, Madrid, Spain. Electronic address: bsuarvil@uax.es.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Luna-Oliva', 'Affiliation': 'Department of Physiotherapy, Occupational Therapy, Rehabilitation and Physical Medicine. Rey Juan Carlos University, Madrid, Spain. Electronic address: laura.luna@urjc.es.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Acebes', 'Affiliation': 'Department of Physical Education, Sport and Human Movement, Autonomous University of Madrid, Madrid, Spain. Electronic address: carla.acebes@estudiante.uam.es.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Villagra', 'Affiliation': 'Department of Physical Education, Sport and Human Movement, Autonomous University of Madrid, Madrid, Spain. Electronic address: Ariel.villagra@uam.es.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103643']
893,32404130,"Effect of mobile text messages on antiretroviral medication adherence and patient retention in early HIV care: an open-label, randomized, single center study in south Florida.","BACKGROUND


People with HIV (PHIV) with limited access to health services often experience suboptimal antiretroviral therapy (ART) adherence. We investigated whether a daily text messaging intervention improves ART adherence and retention in early HIV care in PHIV in a south Florida hospital-based clinic.
METHODS


ART-naïve PHIV receiving care through the clinic's Ryan White HIV/AIDS Program were enrolled and randomly assigned to the intervention or control groups with a 1:1 ratio. The intervention group received a 1-way text message daily and the control group received standard care without receiving text message reminders for 6 months. HIV RNA and CD4 cell count were measured at baseline and post-intervention. Adherence to ART was defined as a visual analog scale of ≥ 90%. Retention in care was defined as continued engagement at study end.
RESULTS


94 ART-naïve patients were randomized and 83 (85.6%) completed the study, of which 44 were in the intervention group and 39 were in the control group. At the end of the 6-month study period, adherence to ART was 84.4% in the intervention group versus 73.5% in the control group (OR, 1.9; 95% CI 0.7-5.0; p = 0.194). Retention in care significantly improved in the intervention group compared to the control group with the odds of retention increasing by 20% (OR, 1.2; 95% CI 1.1-1.5; p = 0.006). Undetectable HIV RNA (< 50 copies/mL) was 86.7% in the intervention group versus 73.5% in the control group (OR, 2.3; 95% CI 0.8-6.9; p = 0.112). A significant increase in CD4 cell count and a decrease in HIV RNA were found at study end, with no differences between the two groups.
CONCLUSIONS


In this pilot study, a one-way daily text messaging intervention did not improve ART adherence over a 6-month study period, but significantly enhanced patient retention in early HIV care. Implementation of interventions to improve adherence in this population is required.",2020,"Retention in care significantly improved in the intervention group compared to the control group with the odds of retention increasing by 20% (OR, 1.2; 95% CI 1.1-1.5; p = 0.006).","['south Florida', '94 ART-naïve patients', 'People with HIV (PHIV) with limited access to health services often experience suboptimal antiretroviral therapy (ART) adherence', ""ART-naïve PHIV receiving care through the clinic's Ryan White HIV/AIDS Program"", 'early HIV care in PHIV in a south Florida hospital-based clinic', 'early HIV care']","['1-way text message daily and the control group received standard care without receiving text message reminders', 'mobile text messages', 'daily text messaging intervention']","['adherence to ART', 'CD4 cell count', 'HIV RNA and CD4 cell count', 'HIV RNA', 'Undetectable HIV RNA', 'ART adherence and retention', 'antiretroviral medication adherence and patient retention', 'ART adherence', 'Retention in care']","[{'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}]",,0.124402,"Retention in care significantly improved in the intervention group compared to the control group with the odds of retention increasing by 20% (OR, 1.2; 95% CI 1.1-1.5; p = 0.006).","[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Sherman', 'Affiliation': 'Department of Pharmacy Practice, Nova Southeastern University College of Pharmacy, 3200 South University Drive, Fort Lauderdale, FL, 33328, USA. esherman@nova.edu.'}, {'ForeName': 'Jianli', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Office of Human Research, Memorial Healthcare System, 3111 Stirling Road, Hollywood, FL, 33312, USA.'}, {'ForeName': 'Shara', 'Initials': 'S', 'LastName': 'Elrod', 'Affiliation': 'Department of Pharmacotherapy, University of North Texas System College of Pharmacy, 3500 Camp Bowie Boulevard, Fort Worth, TX, 76107, USA.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Clauson', 'Affiliation': 'Department of Pharmacy Practice, Lipscomb University College of Pharmacy, One University Park Drive, Nashville, TN, 37204, USA.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Alkhateeb', 'Affiliation': 'Qatar University College of Pharmacy, QU Health, Building Ibn Al-Bitar (I06), Doha, Qatar.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Eckardt', 'Affiliation': 'Division of Infectious Diseases, Memorial Healthcare System, 5647 Hollywood Boulevard, Hollywood, FL, 33021, USA.'}]",AIDS research and therapy,['10.1186/s12981-020-00275-2']
894,32404133,Efficacy of a physical activity programme combining individualized aerobic exercise and coaching to improve physical fitness in neuromuscular diseases (I'M FINE): study protocol of a randomized controlled trial.,"BACKGROUND


In individuals with neuromuscular diseases (NMD), symptoms of muscle weakness, fatigue and pain may limit physical activity. Inactivity leads to reduced physical fitness, which further complicates daily life functioning. Due to inconclusive evidence regarding exercise in NMD, the optimal training approach and strategies to preserve an active lifestyle remain to be determined. The physical activity programme I'M FINE, consisting of individualized aerobic exercise to improve physical fitness and coaching to preserve an active lifestyle, was therefore developed. The primary objective of this study will be to evaluate the efficacy of the I'M FINE programme in terms of improved physical fitness in individuals with slowly progressive NMD, compared to usual care.
METHODS


A multicentre, assessor-blinded, two armed, randomized controlled trial will be conducted in a sample of 90 individuals with slowly progressive NMD. Participants motivated to improve their reduced physical fitness will be randomized (ratio 1:1) to the I'M FINE intervention or usual care. The I'M FINE intervention consists of a six-month physical activity programme, including individualized home-based aerobic exercise to improve physical fitness (i.e. peak oxygen uptake), and motivational interviewing coaching (e.g. goal setting, self-management) to adopt and preserve an active lifestyle. Measurements will be performed at baseline, post-intervention, and at 12- and 18-months follow-up. The primary outcome is peak oxygen uptake (VO 2  peak) directly post intervention. Main secondary outcomes are physical capacity, muscle strength, self-efficacy, daily activity, quality of life and markers of metabolic syndrome. The primary analysis compares change in VO 2  peak post-intervention between the intervention and usual care group, with analysis of covariance.
DISCUSSION


The I'M FINE study will provide evidence regarding the efficacy of a physical activity intervention on the physical fitness and active lifestyle over the short- and long-term in individuals with slowly progressive NMD. These outcomes could potentially improve the (inter)national guidelines for efficacy of aerobic exercise programmes and provide insight in achieving a more active lifestyle in NMD.
TRIAL REGISTRATION


(5/11/2018): Netherlands Trial Register NTR7609 (retrospectively registered), https://www.trialregister.nl/trial/7344. However, the Ethics Review Committee of the Amsterdam Medical Center (AMC) approved the study protocol on 7/11/2017. No adjustments were made to the approved study protocol before the first participant enrolment and registration. Registration was done after the second participant enrolment and the information in the register corresponds one on one with the approved study protocol.",2020,"The I'M FINE intervention consists of a six-month physical activity programme, including individualized home-based aerobic exercise to improve physical fitness (i.e. peak oxygen uptake), and motivational interviewing coaching (e.g. goal setting, self-management) to adopt and preserve an active lifestyle.","['individuals with slowly progressive NMD', 'individuals with neuromuscular diseases (NMD', ""neuromuscular diseases (I'M FINE"", '90 individuals with slowly progressive NMD']","['physical activity intervention', ""I'M FINE programme"", 'physical activity programme combining individualized aerobic exercise and coaching', 'aerobic exercise programmes', 'individualized home-based aerobic exercise to improve physical fitness (i.e. peak oxygen uptake), and motivational interviewing coaching (e.g. goal setting, self-management) to adopt and preserve an active lifestyle', 'individualized aerobic exercise']","['physical fitness', 'peak oxygen uptake (VO 2  peak', 'physical capacity, muscle strength, self-efficacy, daily activity, quality of life and markers of metabolic syndrome']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}, {'cui': 'C0205232', 'cui_str': 'Fine'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",90.0,0.0860636,"The I'M FINE intervention consists of a six-month physical activity programme, including individualized home-based aerobic exercise to improve physical fitness (i.e. peak oxygen uptake), and motivational interviewing coaching (e.g. goal setting, self-management) to adopt and preserve an active lifestyle.","[{'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Oorschot', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands. s.oorschot@amsterdamumc.nl.'}, {'ForeName': 'Merel A', 'Initials': 'MA', 'LastName': 'Brehm', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Annerieke C', 'Initials': 'AC', 'LastName': 'van Groenestijn', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Fieke S', 'Initials': 'FS', 'LastName': 'Koopman', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Camiel', 'Initials': 'C', 'LastName': 'Verhamme', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Eftimov', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith G M', 'Initials': 'JGM', 'LastName': 'Jelsma', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam UMC, VU University Medical Center, de Boelelaan 1118, Amsterdam, The Netherlands.'}, {'ForeName': 'Harald T', 'Initials': 'HT', 'LastName': 'Jorstad', 'Affiliation': 'Department of Cardiology, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Nollet', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Voorn', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}]",BMC neurology,['10.1186/s12883-020-01725-0']
895,32404169,"Prevention of acute radiation-induced Proctitis by Aloe vera: a prospective randomized, double-blind, placebo controlled clinical trial in Pelvic Cancer patients.","BACKGROUND


Acute radiation-induced proctitis (ARP) is the most common side effect following radiotherapy for malignant pelvic disease. This study evaluated the efficacy of Aloe vera ointment in prevention of ARP.
METHODS


Forty-two patients receiving external-beam radiotherapy (RT) for pelvic malignancies were randomized to receive either Aloe vera 3% or placebo topical ointment during radiotherapy for 6 weeks. These patients were evaluated based on the severity (grade 0-4) of the following symptoms weekly: rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency. RTOG acute toxicity criteria and psychosocial status of the patients were also recorded weekly. Lifestyle impact of the symptoms, and quantitative measurement of C-reactive protein (CRP), an indicator of systemic inflammation, were also measured.
RESULTS


The results of present study demonstrated a significant preventive effect for Aloe vera in occurrence of symptom index for diarrhea (p < 0.001), rectal bleeding (p < 0.001), and fecal urgency (p = 0.001). The median lifestyle score improved significantly with Aloe vera during RT (p < 0.001). Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009).
CONCLUSION


This study showed that Aloe vera topical ointment was effective in prevention of symptoms of ARP in patients undergoing RT for pelvic cancers.
TRIAL REGISTRATION


IRCT201606042027N6. Registration date: 2016-09-04.",2020,"Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009).
","['patients undergoing RT for pelvic cancers', 'for pelvic malignancies', 'Pelvic Cancer patients', 'Forty-two patients receiving']","['external-beam radiotherapy (RT', 'radiotherapy', 'Aloe vera topical ointment', 'Aloe vera 3% or placebo topical ointment during radiotherapy', 'Aloe vera ointment', 'acute radiation-induced Proctitis by Aloe vera', 'placebo']","['RTOG acute toxicity criteria and psychosocial status', 'median lifestyle score', 'rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency', 'burden of systemic inflammation', 'fecal urgency', 'prevention of symptoms of ARP', 'symptom index for diarrhea', 'quantitative CRP', 'rectal bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0751416', 'cui_str': 'Pelvic Cancer'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4319566', 'cui_str': '42'}]","[{'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C0991554', 'cui_str': 'Cutaneous ointment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0400827', 'cui_str': 'Radiation proctitis'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0337459', 'cui_str': 'Psychosocial status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0034886', 'cui_str': 'Rectal pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0426636', 'cui_str': 'Urgent desire for stool'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0400827', 'cui_str': 'Radiation proctitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",42.0,0.424109,"Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009).
","[{'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Sahebnasagh', 'Affiliation': 'Clinical Research Center, Department of Internal Medicine, Faculty of Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Ghasemi', 'Affiliation': 'Emam Khomeini Hospital, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Akbari', 'Affiliation': 'Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Alipour', 'Affiliation': 'Epidemiology, Faculty of Medicine, Community medicine Department, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Lashkardoost', 'Affiliation': 'School of Public Health, North Khorasan University of Medical Sciences, Bojnurd, I.R, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Ala', 'Affiliation': 'Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Seyed Jalal', 'Initials': 'SJ', 'LastName': 'Hosseinimehr', 'Affiliation': 'Department of Radiopharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salehifar', 'Affiliation': 'Gastrointestinal Cancer Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. salehifare@yahoo.com.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02935-2']
896,32192742,Effectiveness and Safety of Continuous Transverse Abdominal Plane Blocks vs Epidural Analgesia in Donor Nephroureterectomy.,"BACKGROUND


The transverse abdominal plane (TAP) block is sensitive and encompasses peripheral nerves of the anterior abdominal wall. It decreases 27% of the forced vital capacity, 58% of maximum inspiratory, and 51% of the maximum expiratory pressure on the first postoperative day. It is a postoperative analgesic alternative.
OBJECTIVE


The researchers sought to evaluate the effectiveness and safety of the TAP block compared with continuous epidural analgesia in donor nephroureterectomy.
MATERIAL AND METHODS


A controlled clinical trial of 30 randomized patients in 2 groups-TAP and continuous epidural analgesia-was used. In the TAP group, a catheter was installed in the transverse abdominal plane and ropivacaine, 0.375% 20 mL, and ropivacaine, 0.2%, were deposited in an elastomeric infuser. The other group was installed with an epidural catheter; at the end of the surgery, 10mL of ropivacaine 0.2% was administered and connected to an elastomeric infuser. Adverse effects and pain intensity were evaluated in the first 36 hours; Student t test and the χ 2  test were applied.
RESULTS


The study showed similar analgesia in both groups at 6 hours after the procedure (P = .256); better analgesia was seen in the TAP group in the next 30 hours (P = .000). Researchers also found time for bladder catheter removal, ambulation, and minor hospital discharge in the TAP vs the epidural group as follows: 18.2 ± 3.6 vs 21.7 ± 4.4 hours (P = .028), 20 ± 3.5 vs 23.5 ± 4.2 hours (P = .019), and 51.2 ± 8.4 vs 62.4 ± 17.6 hours (P = .035), respectively.
CONCLUSIONS


Continuous TAP blockade is an effective and safe technique. It favors early recovery, early removal of the bladder catheter, ambulation, and discharge.",2020,The study showed similar analgesia in both groups at 6 hours after the procedure (P = .256); better analgesia was seen in the TAP group in the next 30 hours (P = .000).,"['30 randomized patients in 2\xa0groups', 'Donor Nephroureterectomy']","['ropivacaine', 'Continuous Transverse Abdominal Plane Blocks vs Epidural Analgesia', 'TAP', 'TAP and continuous epidural analgesia', 'TAP blockade', 'continuous epidural analgesia', 'TAP block']","['maximum expiratory pressure', 'Adverse effects and pain intensity', 'bladder catheter removal, ambulation, and minor hospital discharge', 'It favors early recovery, early removal of the bladder catheter, ambulation, and discharge', 'analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0027732', 'cui_str': 'Ureteronephrectomy'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0224378', 'cui_str': 'Transverse Abdominal'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]","[{'cui': 'C0232022', 'cui_str': 'Maximum expiratory pressure (observable entity)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0194422', 'cui_str': 'Removal of urinary bladder catheter (procedure)'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",30.0,0.0665617,The study showed similar analgesia in both groups at 6 hours after the procedure (P = .256); better analgesia was seen in the TAP group in the next 30 hours (P = .000).,"[{'ForeName': 'Arnulfo', 'Initials': 'A', 'LastName': 'Calixto-Flores', 'Affiliation': 'High Specialty Medical Unit, Specialty Hospital Dr Antonio Fraga Mouret, La Raza National Medical Center, IMSS, Mexico. Electronic address: drrufo@hotmail.com.'}, {'ForeName': 'Wladimir', 'Initials': 'W', 'LastName': 'Díaz-Angúlo', 'Affiliation': 'Del Valle University Hospital-Myocardium Clinic, Cali, Colombia.'}]",Transplantation proceedings,['10.1016/j.transproceed.2020.02.004']
897,32193249,Effects of Intensive Glycemic Control on Clinical Outcomes Among Patients With Type 2 Diabetes With Different Levels of Cardiovascular Risk and Hemoglobin A 1c  in the ADVANCE Trial.,"OBJECTIVE


To study whether the effects of intensive glycemic control on major vascular outcomes (a composite of major macrovascular and major microvascular events), all-cause mortality, and severe hypoglycemia events differ among participants with different levels of 10-year risk of atherosclerotic cardiovascular disease (ASCVD) and hemoglobin A 1c  (HbA 1c ) at baseline.
RESEARCH DESIGN AND METHODS


We studied the effects of more intensive glycemic control in 11,071 patients with type 2 diabetes (T2D), without missing values, in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial, using Cox models.
RESULTS


During 5 years' follow-up, intensive glycemic control reduced major vascular events (hazard ratio [HR] 0.90 [95% CI 0.83-0.98]), with the major driver being a reduction in the development of macroalbuminuria. There was no evidence of differences in the effect, regardless of baseline ASCVD risk or HbA 1c  level ( P  for interaction = 0.29 and 0.94, respectively). Similarly, the beneficial effects of intensive glycemic control on all-cause mortality were not significantly different across baseline ASCVD risk ( P  = 0.15) or HbA 1c  levels ( P  = 0.87). The risks of severe hypoglycemic events were higher in the intensive glycemic control group compared with the standard glycemic control group (HR 1.85 [1.41-2.42]), with no significant heterogeneity across subgroups defined by ASCVD risk or HbA 1c  at baseline ( P  = 0.09 and 0.18, respectively).
CONCLUSIONS


The major benefits for patients with T2D in ADVANCE did not substantially differ across levels of baseline ASCVD risk and HbA 1c .",2020,"The risks of severe hypoglycemic events were higher in the intensive glycemic control group compared with the standard glycemic control group (HR 1.85 [1.41-2.42]), with no significant heterogeneity across subgroups defined by ASCVD risk or HbA 1c  at baseline ( P  = 0.09 and 0.18, respectively).
","['Patients With Type 2 Diabetes With Different Levels of Cardiovascular Risk and Hemoglobin A 1c  in the ADVANCE Trial', 'participants with different levels of 10-year risk of atherosclerotic cardiovascular disease (ASCVD) and hemoglobin A 1c  (HbA 1c ) at baseline', '11,071 patients with type 2 diabetes (T2D), without missing values, in the Action in Diabetes and Vascular Disease']","['Intensive Glycemic Control', 'intensive glycemic control']","['levels of baseline ASCVD risk and HbA 1c ', 'baseline ASCVD risk or HbA 1c  level', 'ASCVD risk or HbA 1c', 'risks of severe hypoglycemic events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",11071.0,0.0675695,"The risks of severe hypoglycemic events were higher in the intensive glycemic control group compared with the standard glycemic control group (HR 1.85 [1.41-2.42]), with no significant heterogeneity across subgroups defined by ASCVD risk or HbA 1c  at baseline ( P  = 0.09 and 0.18, respectively).
","[{'ForeName': 'Jingyan', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'State Key Laboratory of Medical Genomics, Shanghai Institute of Endocrine and Metabolic Diseases, Department of Endocrinology and Metabolism, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cooper', 'Affiliation': 'Department of Diabetes, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrap', 'Affiliation': 'The University of Melbourne and The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': 'Istituto Auxologico Italiano, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Poulter', 'Affiliation': 'International Center for Circulatory Health, Imperial College, London, U.K.'}, {'ForeName': 'Ji-Guang', 'Initials': 'JG', 'LastName': 'Wang', 'Affiliation': 'Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Shanghai Key Laboratory of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Zoungas', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia chalmers@georgeinstitute.org.au.'}]",Diabetes care,['10.2337/dc19-1817']
898,31336051,Throwing Injuries in Youth Baseball Players: Can a Prevention Program Help? A Randomized Controlled Trial.,"BACKGROUND


Throwing injuries of the shoulder and elbow are common among youth baseball players.
HYPOTHESIS


A prevention program will reduce the incidence of throwing injuries of the shoulder and elbow by 50% among youth baseball players.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


The authors block randomized 16 youth baseball teams consisting of 237 players aged 9 to 11 years into an intervention group (8 teams, 117 players) and a control group (8 teams, 120 players). The intervention program consisted of 5 stretching, 2 dynamic mobility, and 2 balance training exercises performed during warm-up. Both groups were followed up for 12 months, during which the incidence of shoulder and elbow injuries was recorded. In addition, ball speed during pitching as a performance-related factor and variables of physical function (passive range of motion of the elbow, shoulder and hip, dynamic balance, and thoracic kyphosis angle) were assessed during the pre- and postintervention periods.
RESULTS


The incidence of shoulder and elbow injuries in the intervention group (1.7 per 1000 athlete-exposures) was significantly lower than that in the control group (3.1 per 1000 athlete-exposures) (hazard ratio, 1.940; 95% CI, 1.175-3.205;  P  = .010). The factors related to pitching performance, as assessed by ball speed, tended to increase in the intervention group as compared with the control group ( P  = .010). The program also improved shoulder horizontal adduction deficits on the dominant side, hip internal rotation on the nondominant side, and the thoracic kyphosis angle.
CONCLUSION


A prevention program decreases throwing injuries of the shoulder and elbow and enhances the parameter of pitching performance in youth baseball players.",2019,"The program also improved shoulder horizontal adduction deficits on the dominant side, hip internal rotation on the nondominant side, and the thoracic kyphosis angle.
","['Youth Baseball Players', 'youth baseball players', '16 youth baseball teams consisting of 237 players aged 9 to 11 years into an intervention group (8 teams, 117 players) and a control group (8 teams, 120 players']","['5 stretching, 2 dynamic mobility, and 2 balance training exercises performed during warm-up']","['incidence of shoulder and elbow injuries', 'shoulder horizontal adduction deficits', 'ball speed during pitching as a performance-related factor and variables of physical function (passive range of motion of the elbow, shoulder and hip, dynamic balance, and thoracic kyphosis angle']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0149674', 'cui_str': 'Injury of elbow'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0231457', 'cui_str': 'Adduction, function (observable entity)'}, {'cui': 'C0175681', 'cui_str': 'Pitch (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0079991', 'cui_str': 'Passive Range of Motion'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0022823'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}]",16.0,0.0499257,"The program also improved shoulder horizontal adduction deficits on the dominant side, hip internal rotation on the nondominant side, and the thoracic kyphosis angle.
","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sakata', 'Affiliation': 'Faculty of Sports Sciences, Waseda University, Tokyo, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Nakamura', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Tatsuhiro', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Rehabilitation, Midori Clinic, Mie, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Suzukawa', 'Affiliation': 'Department of Rehabilitation, Yokohama Sports Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Akeda', 'Affiliation': 'Department of Orthopedic Sports Medicine, Yokohama Minami Kyosai Hospital, Kanagawa, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Orthopedic Sports Medicine, Yokohama Minami Kyosai Hospital, Kanagawa, Japan.'}, {'ForeName': 'Todd S', 'Initials': 'TS', 'LastName': 'Ellenbecker', 'Affiliation': 'Rehab Plus Sports Therapy, Scottsdale, Arizona, USA.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Hirose', 'Affiliation': 'Faculty of Sports Sciences, Waseda University, Tokyo, Japan.'}]",The American journal of sports medicine,['10.1177/0363546519861378']
899,31852816,Vascular safety of erenumab for migraine prevention.,"OBJECTIVE


To examine the cardiovascular, cerebrovascular, and peripheral vascular safety of erenumab across migraine prevention studies.
METHODS


Vascular adverse events (AEs) and blood pressure data were integrated across 4 double-blind, placebo-controlled studies of erenumab and their open-label extensions in patients with chronic or episodic migraine. Subgroup analyses were conducted by acute migraine-specific medication use and number of vascular risk factors at baseline. Standardized search terms were used to identify vascular AEs (cardiovascular, cerebrovascular, or peripheral). An independent committee adjudicated whether targeted events were vascular in origin.
RESULTS


In placebo-controlled studies, 2,443 patients received placebo (n = 1,043), erenumab 70 mg (n = 893), or erenumab 140 mg (n = 507) subcutaneously once monthly. Regardless of acute migraine-specific medication use or vascular risk factors at baseline, AE incidence was similar across the placebo and erenumab treatment groups. Hypertension AEs were reported for 0.9% (placebo), 0.8% (erenumab 70 mg), and 0.2% (erenumab 140 mg) of patients. Vascular AEs, which were similar across double-blind and open-label treatment, generally were confounded, with plausible alternative etiologies. In 18 patients with events reviewed by the independent committee, 4 events were positively adjudicated as cardiovascular in origin: 2 deaths and 2 vascular events. All 4 positively adjudicated cardiovascular events occurred during open-label erenumab treatment.
CONCLUSION


Selective blockade of the canonical calcitonin gene-related peptide receptor with erenumab for migraine prevention had a vascular safety profile comparable to that of placebo over 12 weeks, with no increased emergence of events over time. Further study of long-term safety of erenumab in patients with migraine is needed.
CLINICALTRIALSGOV IDENTIFIERS


NCT02066415, NCT02456740, NCT01952574, NCT02483585, NCT02174861, and NCT01723514.
CLASSIFICATION OF EVIDENCE


This analysis provides Class II evidence that for patients with migraine, erenumab does not increase the risk of vascular AEs.",2020,"Selective blockade of the canonical calcitonin gene-related peptide receptor with erenumab for migraine prevention had a vascular safety profile comparable to that of placebo over 12 weeks, with no increased emergence of events over time.","['patients with migraine', '18 patients with events', '2,443 patients received', 'patients with chronic or episodic migraine']","['placebo', 'placebo-controlled studies of erenumab and their open-label extensions']","['Vascular adverse events (AEs) and blood pressure data', 'acute migraine-specific medication use and number of vascular risk factors', 'cardiovascular in origin: 2 deaths and 2 vascular events', 'Hypertension AEs', 'Vascular safety', 'cardiovascular events', 'vascular AEs (cardiovascular, cerebrovascular, or peripheral']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}]",2443.0,0.420516,"Selective blockade of the canonical calcitonin gene-related peptide receptor with erenumab for migraine prevention had a vascular safety profile comparable to that of placebo over 12 weeks, with no increased emergence of events over time.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kudrow', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA. dbkudrow@earthlink.net.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Pascual', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Winner', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.'}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klatt', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.'}, {'ForeName': 'Sunfa', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Picard', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.'}, {'ForeName': 'Osa', 'Initials': 'O', 'LastName': 'Eisele', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Latham', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'From California Medical Clinic for Headache (D.K.), Santa Monica, CA; Department of Neurology (J.P.), University Hospital Marqués de Valdecilla and IDIVAL, Santander, Spain; Premiere Research Institute (P.K.W.), Nova Southeastern University, West Palm Beach, FL; Department of Neurology (D.W.D.), Mayo Clinic, Phoenix, AZ; Department of Neurology (S.J.T.), Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Novartis, East Hanover, NJ (F.H.), and Basel, Switzerland (J.K.); Amgen Inc. (F.Z., S.C., H.P., O.E., J.W., D.D.M.), Thousand Oaks, CA; and PharmaScribe, LLC (J.N.L.), Atlanta, GA.'}]",Neurology,['10.1212/WNL.0000000000008743']
900,32402702,Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial.,"BACKGROUND


Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients.
METHODS


The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI.
RESULTS


More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea.
CONCLUSION


This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients.",2020,"The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI.
","['high-risk PCI patients', 'high-risk patients who underwent percutaneous coronary intervention', 'patients with high-risk anatomic or clinical characteristics who underwent PCI', '1700 high-risk PCI patients']","['routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing', 'routine versus no routine functional testing', 'percutaneous coronary intervention (PCI) with drug-eluting stents (DES']","['composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0920208', 'cui_str': 'Stress echocardiogram'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0562340', 'cui_str': 'Poor daily routine'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",,0.0929061,"The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI.
","[{'ForeName': 'Yong-Hoon', 'Initials': 'YH', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hanbit', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Cheol', 'Initials': 'SC', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Pil Hyung', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Hur', 'Affiliation': 'Division of Cardiology, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Won-Jang', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Chul Soo', 'Initials': 'CS', 'LastName': 'Park', 'Affiliation': ""Cardiovascular Center and Cardiology Division, Yeouido St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Bong-Ki', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Kangwon National University Hospital, Chuncheon, Republic of Korea.'}, {'ForeName': 'Jung-Won', 'Initials': 'JW', 'LastName': 'Suh', 'Affiliation': 'Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Jung Han', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Wonju Christian Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'Jae Woong', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Eulji General Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Sik', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Catholic University of Daegu, Daegu, Republic of Korea.'}, {'ForeName': 'Si Wan', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Su Nam', 'Initials': 'SN', 'LastName': 'Lee', 'Affiliation': ""Division of Cardiology, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Republic of Korea.""}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: dwpark@amc.seoul.kr.'}]",American heart journal,['10.1016/j.ahj.2020.03.019']
901,32404116,Effects of active localization and vascular preservation of inferior parathyroid glands in central neck dissection for papillary thyroid carcinoma.,"BACKGROUND


The purpose of present study is to assess the effects of active localization and vascular preservation of inferior parathyroid glands in central neck dissection (CND) for papillary thyroid carcinoma (PTC).
METHODS


A classification of IPGs according to their location and vascular features was developed, and, based on this classification, a CND procedure was designed, and IPGs and their vascular were actively localized and strategically preserved. A total of 197 patients with PTC who underwent a total thyroidectomy and concomitant CND were enrolled. Eighty-nine patients with traditional meticulous fascia dissection were allocated to group A, and 108 patients with active location and vascular preservation of IPGs were allocated to group B. Those with inferior parathyroid glands auto-transplantation in each group were assigned as group At (18) and group Bt (12). Variables including serum intact parathyroid hormone (PTH), total calcium, the incidence of transient, and permanent hypoparathyroidism were studied.
RESULTS


Compared with group A, serum intact PTH (P < 0.001) and total calcium levels (P < 0.05) in group B significantly improved on the first postoperative day, and the incidence of transient hypoparathyroidism significantly dropped in group B (P < 0.001). A total of 170 patients in the two groups had complete follow-up data. The incidence of permanent hypoparathyroidism significantly decreased in group B, from 8.8% to 1.0% (P = 0.017). However, there were no significant differences in all variables between group Bt and group At.
CONCLUSION


Active location and vascular preservation of inferior parathyroid glands effectively protected the function of IPGs in CND for PTC.",2020,"Compared with group A, serum intact PTH (P < 0.001) and total calcium levels (P < 0.05) in group B significantly improved on the first postoperative day, and the incidence of transient hypoparathyroidism significantly dropped in group B (P < 0.001).","['197 patients with PTC who underwent a total thyroidectomy and concomitant CND were enrolled', 'Eighty-nine patients with traditional meticulous fascia dissection', 'central neck dissection for papillary thyroid carcinoma', '170 patients in the two groups had complete follow-up data', '108 patients with active location and vascular preservation of IPGs', 'central neck dissection (CND) for papillary thyroid carcinoma (PTC']","['inferior parathyroid glands auto-transplantation', 'active localization and vascular preservation of inferior parathyroid glands']","['incidence of transient hypoparathyroidism', 'incidence of permanent hypoparathyroidism', 'serum intact PTH', 'total calcium levels', 'serum intact parathyroid hormone (PTH), total calcium, the incidence of transient, and permanent hypoparathyroidism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0447650', 'cui_str': 'Inferior parathyroid gland'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1282979', 'cui_str': 'Transient hypoparathyroidism'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0040704', 'cui_str': 'Transients'}]",197.0,0.138386,"Compared with group A, serum intact PTH (P < 0.001) and total calcium levels (P < 0.05) in group B significantly improved on the first postoperative day, and the incidence of transient hypoparathyroidism significantly dropped in group B (P < 0.001).","[{'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Hou', 'Affiliation': 'Department of General Surgery, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan Street, Gulou District, Nanjing, 210011, NO, China.'}, {'ForeName': 'Haie', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'The School of Public Health, Nanjing Medical University, Nanjing, 211166, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yuan', 'Affiliation': 'Department of General Surgery, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan Street, Gulou District, Nanjing, 210011, NO, China.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan Street, Gulou District, Nanjing, 210011, NO, China.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Information and Data, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, China.'}, {'ForeName': 'Zhuyin', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': 'Department of General Surgery, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan Street, Gulou District, Nanjing, 210011, NO, China. zhuyin_qian66@163.com.'}]",World journal of surgical oncology,['10.1186/s12957-020-01867-y']
902,32404117,Effects of prostaglandin E 1  nebulization of ventilated lung under 60%O 2  one lung ventilation on patients' oxygenation and oxidative stress: a randomised controlled trial.,"BACKGROUND


High FiO 2  during one-lung ventilation (OLV) can improve oxygenation, but increase the risk of atelectasis and oxidative stress. The aim of this study was to analyze whether Prostaglandin E 1  (PGE 1 ) can improve oxygenation and attenuate oxidative stress during OLV under a lower FiO 2 .
METHOD


Ninety patients selectively undergoing thoracotomy for esophageal cancer were randomly divided into three groups (n = 30/group): Group P (FiO 2  = 0.6, inhaling PGE 1  0.1 μg/kg), Group L (FiO 2  = 0.6) and Group C (FiO 2  = 1.0). The primary outcomes were oxygenation and pulmonary shunt during OLV. Secondary outcomes included haemodynamics, respiratory mechanics and oxidative stress in serum.
RESULTS


Patients in Group P had significantly higher PaO 2  and lower shunt fraction in 30 min of OLV compared with Group L. Compared with Group C, patients in Group P had similar levels of PaO 2 /FiO 2  in 60 min and higher levels of PaO 2 /FiO 2  at 2 h during OLV. The levels of PvO 2  and SvO 2  in Group P and Group L were significantly lower than Group C. Patients in Group P and Group L had significantly higher levels of superoxide dismutase and lower levels of malondialdehyde than Group C. No significant differences were found in SPO 2 , ETCO 2 , PaCO 2 , Paw, HR and MAP among the three groups. The complications in Group C were significantly higher than another two groups.
CONCLUSION


PGE 1  can maintain adequate oxygenation in patients with low FiO 2  (0.6) during OLV. Reducing FiO 2  to 0.6 during OLV can decrease the levels of oxidative stress and complications after OLV.
TRIAL REGISTRATION


chictr.org.cn identifier: ChiCTR1800017100.",2020,"The levels of PvO 2  and SvO 2  in Group P and Group L were significantly lower than Group C. Patients in Group P and Group L had significantly higher levels of superoxide dismutase and lower levels of malondialdehyde than Group C. No significant differences were found in SPO 2 , ETCO 2 , PaCO 2 , Paw, HR and MAP among the three groups.","['Ninety patients selectively undergoing thoracotomy for esophageal cancer', ""ventilated lung under 60%O 2  one lung ventilation on patients' oxygenation and oxidative stress""]","['prostaglandin E', 'Prostaglandin E 1  (PGE 1 ']","['haemodynamics, respiratory mechanics and oxidative stress in serum', 'superoxide dismutase and lower levels of malondialdehyde', 'PaO 2  and lower shunt fraction', 'oxygenation and attenuate oxidative stress', 'SPO 2 , ETCO 2 , PaCO 2 , Paw, HR and MAP', 'levels of PvO 2  and SvO 2', 'levels of oxidative stress and complications', 'oxygenation and pulmonary shunt during OLV']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]","[{'cui': 'C0033559', 'cui_str': 'E series prostaglandin'}, {'cui': 'C0002335', 'cui_str': 'Alprostadil'}]","[{'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]",90.0,0.0867962,"The levels of PvO 2  and SvO 2  in Group P and Group L were significantly lower than Group C. Patients in Group P and Group L had significantly higher levels of superoxide dismutase and lower levels of malondialdehyde than Group C. No significant differences were found in SPO 2 , ETCO 2 , PaCO 2 , Paw, HR and MAP among the three groups.","[{'ForeName': 'Pengyi', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42 Baiziting, Xuanwu District, Nanjing, 210009, China.'}, {'ForeName': 'Lianbing', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42 Baiziting, Xuanwu District, Nanjing, 210009, China.'}, {'ForeName': 'Qingming', 'Initials': 'Q', 'LastName': 'Bian', 'Affiliation': 'Department of Anesthesiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42 Baiziting, Xuanwu District, Nanjing, 210009, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Department of Anesthesiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42 Baiziting, Xuanwu District, Nanjing, 210009, China.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Jiao', 'Affiliation': 'Department of Anesthesiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42 Baiziting, Xuanwu District, Nanjing, 210009, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Renji Clinical School, Shanghai Jiao Tong University School of Medicine, Shanghai, 200000, China.'}, {'ForeName': 'Zeping', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42 Baiziting, Xuanwu District, Nanjing, 210009, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42 Baiziting, Xuanwu District, Nanjing, 210009, China. wangljun520@163.com.'}]",Respiratory research,['10.1186/s12931-020-01380-6']
903,32404897,Impact of interdental brush shape on interpapillary cleaning efficacy - a clinical trial.,"This study aimed to investigate whether interdental brush shape influences cleaning efficacy, by comparing a waist-shaped interdental brush (W-IDB) with a cylindrical IDB (C-IDB); both provided with the same bristle texture. Cleaning efficacy of differently shaped IDBs was measured in proximal surfaces of teeth in a split-mouth cross-over design. Twenty-eight patients abolished oral hygiene for 4 d. Line angle plaque area was scanned with an intraoral camera after use of disclosing dye in baseline and after IDB application and analyzed planimetrically. Additionally, bacterial load in the IDBs was analyzed after usage by colony forming units (cfu). A Wilcoxon signed-rank test with continuity correction was used to compare the results of the waist-shaped and the cylindrically-shaped IDBs. The waist-shaped IDBs cleaned significantly better than their cylindrically-shaped counterparts (area cleaned: 23.1% vs. 18.3%), when applied at same interdental spaces (p < 0.001). However, no significant differences were found in comparison of bacterial load on the IDBs (median cfu counts: 2.3E9 vs. 2.7E9, p = 0.93). Irrespective of bristle texture or size, IDB shape have impact on cleaning efficacy. Waist-shaped IDBs are more effective in cleaning of the line angle area than cylindrically-shaped IDBs.",2020,"The waist-shaped IDBs cleaned significantly better than their cylindrically-shaped counterparts (area cleaned: 23.1% vs. 18.3%), when applied at same interdental spaces (p < 0.001).",[],['cylindrical IDB (C-IDB'],['waist-shaped IDBs cleaned'],[],"[{'cui': 'C0205114', 'cui_str': 'Cylindrical'}]","[{'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}]",28.0,0.0264411,"The waist-shaped IDBs cleaned significantly better than their cylindrically-shaped counterparts (area cleaned: 23.1% vs. 18.3%), when applied at same interdental spaces (p < 0.001).","[{'ForeName': 'Pune N', 'Initials': 'PN', 'LastName': 'Paqué', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland. punenina.paque@zzm.uzh.ch.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Attin', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ender', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al-Majid', 'Affiliation': 'Dental department, King Faisal Hospital, Prince Muqrin St 1, 36361, Alhofuf, Saudi Arabia.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Wegehaupt', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Sener', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Schmidlin', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032, Zurich, Switzerland.'}]",Scientific reports,['10.1038/s41598-020-64816-5']
904,32404919,Short rehabilitation training program may improve postural control in children with autism spectrum disorders: preliminary evidences.,"Autism Spectrum Disorders subjects (ASD) is characterized by postural control deficits. This study aimed to explore the effect of a short postural rehabilitation training program on postural capabilities in children with ASD. Two groups (G1 and G2) of twenty children with ASD of IQ-, sex- and age- matched (mean age 11.7 ± 2.4 years) were included in this study. Posture was recorded by using the Balance Quest from Framiral on unstable platform in three different viewing conditions. The rehabilitation program consisted in two distinct postural control training exercises. Postural recordings were performed twice at T1 and T2 for both groups of children. Between T1 and T2 a 6-minute postural training was performed by the G1 group only, while the G2 group had a 6-minute of rest. Children were allocated randomly to the G1 or G2 groups. At T1, postural instability was similar for both groups of ASD children (G1 and G2) desp+\ite viewing conditions. At T2, we observed an improvement of postural control related to a mixed effect of training rehabilitation but also of test-retest. Knowing the potential of new rehabilitation strategies, the impact of postural control deficit in ASD children needs to be reconsidered. Well design case-control studies are requested to ensure scientific validity of postural rehabilitation training program.",2020,"At T1, postural instability was similar for both groups of ASD children (G1 and G2) desp+\ite viewing conditions.","['children with ASD', 'Autism Spectrum Disorders subjects (ASD', 'children with autism spectrum disorders', 'twenty children with ASD of IQ-, sex- and age- matched (mean age 11.7\u2009±\u20092.4 years']","['short postural rehabilitation training program', 'Short rehabilitation training program', 'rehabilitation program consisted in two distinct postural control training exercises']","['postural capabilities', 'postural instability', 'postural control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C1843921', 'cui_str': 'Postural instability'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",20.0,0.0112101,"At T1, postural instability was similar for both groups of ASD children (G1 and G2) desp+\ite viewing conditions.","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Caldani', 'Affiliation': 'UMR 1141 NeuroDiderot Inserm, Paris University, Robert Debré Hospital, Paris, France. simona.caldani@gmail.com.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Atzori', 'Affiliation': 'Child and Adolescent Psychiatry Department, APHP, Robert Debré Hospital, Paris, France.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Peyre', 'Affiliation': 'UMR 1141 NeuroDiderot Inserm, Paris University, Robert Debré Hospital, Paris, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Delorme', 'Affiliation': 'Child and Adolescent Psychiatry Department, APHP, Robert Debré Hospital, Paris, France.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Bucci', 'Affiliation': 'UMR 1141 NeuroDiderot Inserm, Paris University, Robert Debré Hospital, Paris, France.'}]",Scientific reports,['10.1038/s41598-020-64922-4']
905,32404980,Proteomic profiles before and during weight loss: Results from randomized trial of dietary intervention.,"Inflammatory and cardiovascular biomarkers have been associated with obesity, but little is known about how they change upon dietary intervention and concomitant weight loss. Further, protein biomarkers might be useful for predicting weight loss in overweight and obese individuals. We performed secondary analyses in the Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) randomized intervention trial that included healthy 609 adults (18-50 years old) with BMI 28-40 kg/m 2 , to evaluate associations between circulating protein biomarkers and BMI at baseline, during a weight loss diet intervention, and to assess predictive potential of baseline blood proteins on weight loss. We analyzed 263 plasma proteins at baseline and 6 months into the intervention using the Olink Proteomics CVD II, CVD III and Inflammation arrays. BMI was assessed at baseline, after 3 and 6 months of dietary intervention. At baseline, 102 of the examined inflammatory and cardiovascular biomarkers were associated with BMI (>90% with successful replication in 1,584 overweight/obese individuals from a community-based cohort study) and 130 tracked with weight loss shedding light into the pathophysiology of obesity. However, out of 263 proteins analyzed at baseline, only fibroblast growth factor 21 (FGF-21) predicted weight loss, and none helped individualize dietary assignment.",2020,"However, out of 263 proteins analyzed at baseline, only fibroblast growth factor 21 (FGF-21) predicted weight loss, and none helped individualize dietary assignment.","['overweight and obese individuals', 'healthy 609 adults (18-50 years old) with BMI 28-40\u2009kg/m 2']",['dietary intervention'],"['fibroblast growth factor 21 (FGF-21) predicted weight loss', 'weight loss', 'BMI']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",1584.0,0.0195217,"However, out of 263 proteins analyzed at baseline, only fibroblast growth factor 21 (FGF-21) predicted weight loss, and none helped individualize dietary assignment.","[{'ForeName': 'Sylwia M', 'Initials': 'SM', 'LastName': 'Figarska', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, CA, 94305, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rigdon', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ganna', 'Affiliation': 'Program in Medical and Population Genetics, Broad Institute of MIT and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Sölve', 'Initials': 'S', 'LastName': 'Elmståhl', 'Affiliation': 'Department of Clinical Sciences, Division of Geriatric Medicine, Lund University, Malmö University Hospital, Malmö, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lind', 'Affiliation': 'Department of Medical Sciences, Cardiovascular Epidemiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Diabetes Research Center, Stanford, CA, 94305, USA. cgardner@stanford.edu.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Ingelsson', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, CA, 94305, USA.'}]",Scientific reports,['10.1038/s41598-020-64636-7']
906,32401941,Effect of music at 432 Hz and 440 Hz on dental anxiety and salivary cortisol levels in patients undergoing tooth extraction: a randomized clinical trial.,"Objective The aim of this study was to compare the effects of music at 432 Hz, 440 Hz, and no music on the clinical perception of anxiety and salivary cortisol levels in patients undergoing tooth extraction. Methodology A parallel-group randomized clinical trial was conducted. Forty-two patients (average age: 23.8±7.8 years, 27 women) with a moderate level of anxiety were distributed in three groups: use of music for 15 minutes at a frequency of 432 Hz (n=15), at 440 Hz (n=15) and a control group without music (n=12). The CORAH Dental Anxiety Scale and salivary cortisol levels, estimated by the solid phase enzyme-linked immunosorbent assay (ELISA), were measured and compared before and after the music intervention between groups (two-way ANOVA-Tukey p<0.05, RStudio). Results Significantly lower anxiety level values were observed at 432 Hz (8.7±2.67) and 440 Hz (8.4±2.84) compared to the control group (17.2±4.60; p<0.05). The salivary cortisol level at 432 Hz (0.49±0.37 μg/dL) was significantly lower than 440 Hz (1.35±0.69 μg/dL) and the control group (1.59±0.7 μg/dL; p<0.05). Conclusion The use of music significantly decreased clinical anxiety levels, and the frequency of 432 Hz was effective in decreasing salivary cortisol levels before tooth extraction.",2020,Results Significantly lower anxiety level values were observed at 432 Hz (8.7±2.67) and 440 Hz (8.4±2.84) compared to the control group (17.2±4.60; p<0.05).,"['Forty-two patients (average age: 23.8±7.8 years, 27 women) with a moderate level of anxiety', 'patients undergoing tooth extraction']","['control group without music', 'music at 432 Hz, 440 Hz, and no music', 'music at 432 Hz and 440 Hz']","['CORAH Dental Anxiety Scale and salivary cortisol levels, estimated by the solid phase enzyme-linked immunosorbent assay (ELISA', 'salivary cortisol level', 'clinical perception of anxiety and salivary cortisol levels', 'clinical anxiety levels', 'salivary cortisol levels', 'dental anxiety and salivary cortisol levels', 'anxiety level values']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C4517777', 'cui_str': '440'}]","[{'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",42.0,0.112363,Results Significantly lower anxiety level values were observed at 432 Hz (8.7±2.67) and 440 Hz (8.4±2.84) compared to the control group (17.2±4.60; p<0.05).,"[{'ForeName': 'Pedro Christian', 'Initials': 'PC', 'LastName': 'Aravena', 'Affiliation': 'Instituto de Anatomía, Histología y Patología, Facultad de Medicina, Universidad Austral de Chile, Valdivia, Chile.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Almonacid', 'Affiliation': 'Escuela de Odontología, Facultad de Medicina, Universidad Austral de Chile, Valdivia, Chile.'}, {'ForeName': 'Marcelo Ignacio', 'Initials': 'MI', 'LastName': 'Mancilla', 'Affiliation': 'Escuela de Odontología, Facultad de Medicina, Universidad Austral de Chile, Valdivia, Chile.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2019-0601']
907,32401967,Posterior Capsule Opacification after Cataract Surgery in Children Over Five Years of Age with Square-edge Hydrophobic versus Hydrophilic Acrylic Intraocular Lenses: A Prospective Randomized Study.,"OBJECTIVE


To compare the effects of hydrophobic and hydrophilic materials in square-edged acrylic intraocular lenses (IOLs) on the development of posterior capsule opacification (PCO) after pediatric cataract surgery.
METHODS


Patients were randomly assigned to group 1 (hydrophobic acrylic square-edged IOLs; 13 eyes) or group 2 (hydrophilic acrylic square-edged IOLs; 13 eyes). The study evaluated PCO rates using Evaluation of Posterior Capsule Opacification (EPCO) 2000 software at one, three, six and 12 months postoperatively. Postoperative measurements also included corrected distance visual acuity (CDVA), neodymium:yttrium-aluminum-garnet (Nd:YAG) capsulotomy and postoperative complications other than PCO.
RESULTS


Both groups had significant increases in PCO rates after one year. Comparison of the groups showed no significant differences in the EPCO scores at three (group 1, 0.007±0.016 vs group 2, 0.008±0.014; p=0.830), six (group 1, 0.062±0.103 vs group 2, 0.021±0.023; p=0.184), or twelve months postoperatively (group 1, 0.200±0.193 vs group 2, 0.192±0.138; p=0.902). We also found no significant group differences regarding the change (delta, Δ) in EPCO scores between three and six months (group 1, 0.055±0.09 vs group 2, 0.013±0.02; p=0.113) or between six and twelve months postoperatively (group 1, 0.139±0.14 vs group 2, 0.171±0.14; p=0.567). Twenty-three percent of patients required Nd:YAG capsulotomy at the twelve-month visit.
CONCLUSIONS


No differences in PCO rates were found between hydrophobic and hydrophilic acrylic square-edged IOLs in children between five and twelve years of age at one year of follow-up.",2020,No differences in PCO rates were found between hydrophobic and hydrophilic acrylic square-edged IOLs in children between five and twelve years of age at one year of follow-up.,"['posterior capsule opacification (PCO) after pediatric cataract surgery', 'Children', 'Patients']","['acrylic intraocular lenses (IOLs', 'hydrophobic and hydrophilic materials', 'hydrophobic acrylic square-edged IOLs; 13 eyes) or group 2 (hydrophilic acrylic square-edged IOLs', 'Hydrophilic Acrylic Intraocular Lenses']","['corrected distance visual acuity (CDVA), neodymium:yttrium-aluminum-garnet', 'PCO rates', 'EPCO scores']","[{'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0475370', 'cui_str': 'Hydrophilic'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0547806,No differences in PCO rates were found between hydrophobic and hydrophilic acrylic square-edged IOLs in children between five and twelve years of age at one year of follow-up.,"[{'ForeName': 'Camila Ribeiro', 'Initials': 'CR', 'LastName': 'Koch', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Marcony R', 'Initials': 'MR', 'LastName': 'Santhiago', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Priscilla A', 'Initials': 'PA', 'LastName': 'Jorge', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Sena', 'Affiliation': 'Hospital Humberto Castro Lima, Salvador, BA, BR.'}, {'ForeName': 'Newton', 'Initials': 'N', 'LastName': 'Kara-Júnior', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1604']
908,32402161,Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.,"BACKGROUND


Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis.
METHODS


We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of  Lactobacillus crispatus  CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12.
RESULTS


A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit,  L. crispatus  CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups.
CONCLUSIONS


The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).",2020,"At the 12-week visit,  L. crispatus  CTV-05 was detected in 79% of participants in the Lactin-V group.","['228 women underwent randomization: 152 to the Lactin-V group and 76 to the', 'Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements']","['vaginal metronidazole', 'vaginally administered Lactin-V or placebo', 'Lactobacillus crispatus  CTV-05 (Lactin-V', 'Lactin-V', 'placebo']","['recurrence of bacterial vaginosis', 'risk ratio for recurrence', 'percentage of women who had a recurrence of bacterial vaginosis', 'percentage of participants with local or systemic adverse events', 'Recurrence of Bacterial Vaginosis']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0595096', 'cui_str': 'Metronidazole-containing product in vaginal dose form'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0595096', 'cui_str': 'Metronidazole-containing product in vaginal dose form'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0317614', 'cui_str': 'Lactobacillus crispatus'}, {'cui': 'C0454198', 'cui_str': 'Clinical target volume'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",228.0,0.642452,"At the 12-week visit,  L. crispatus  CTV-05 was detected in 79% of participants in the Lactin-V group.","[{'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Wierzbicki', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'French', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Newmann', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Reno', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Green', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Miller', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Parks', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Hemmerling', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}]",The New England journal of medicine,['10.1056/NEJMoa1915254']
909,32197030,Effect of subarachnoid anesthesia combined with propofol target-controlled infusion on blood loss and transfusion for posterior total hip arthroplasty in elderly patients.,"BACKGROUND


Intravertebral and general anesthesia (GA) are two main anesthesia approaches but both have defects. This study was aimed to evaluate the effect of subarachnoid anesthesia combined with propofol target-controlled infusion (TCI) on blood loss and transfusion for total hip arthroplasty (THA) in elderly patients in comparison with combined spinal-epidural anesthesia (CSEA) or GA.
METHODS


Totally, 240 patients (aged ≥65 years, American Society of Anesthesiologists [ASA] I-III) scheduled for posterior THA were enrolled from September 1st, 2017 to March 1st, 2018. All cases were randomly divided into three groups to receive CSEA (group C, n = 80), GA (group G, n = 80), or subarachnoid anesthesia and propofol TCI (group T, n = 80), respectively. Primary outcomes measured were intra-operative blood loss, autologous and allogeneic blood transfusion, mean arterial pressure at different time points, length of stay in post-anesthesia care unit (PACU), length of hospital stay, and patient satisfaction degree. Furthermore, post-operative pain scores and complications were also observed. The difference of quantitative index between groups were analyzed by one-way analysis of variance, repeated measurement generalized linear model, Student-Newman-Keuls test or rank-sum test, while ratio index was analyzed by Chi-square test or Fisher exact test.
RESULTS


Basic characteristics were comparable among the three groups. Intra-operative blood loss in group T (331.53 ± 64.33 mL) and group G (308.03 ± 64.90 mL) were significantly less than group C (455.40 ± 120.48 mL, F = 65.80, P < 0.001). Similarly, the autologous transfusion of group T (130.99 ± 30.36 mL) and group G (124.09 ± 24.34 mL) were also markedly less than group C (178.31 ± 48.68 mL, F = 52.99, P < 0.001). The allogenetic blood transfusion of group C (0 [0, 100.00]) was also significantly larger than group T (0) and group G (0) (Z = 2.47, P = 0.047). Except for the baseline, there were significant differences in mean arterial blood pressures before operation (F = 496.84, P < 0.001), 10-min after the beginning of operation (F = 351.43, P < 0.001), 30-min after the beginning of operation (F = 559.89, P < 0.001), 50-min after the beginning of operation (F = 374.74, P < 0.001), and at the end of operation (F = 26.14, P < 0.001) among the three groups. Length of stay in PACU of group T (9.41 ± 1.19 min) was comparable with group C (8.83 ± 1.26 min), and both were significantly shorter than group G (16.55 ± 3.10 min, F = 352.50, P < 0.001). There were no significant differences among the three groups in terms of length of hospitalization and post-operative visual analog scale scores. Patient satisfaction degree of group T (77/80) was significantly higher than group C (66/80, χ = 7.96, P = 0.004) and G (69/80, χ = 5.01, P = 0.025). One patient complained of post-dural puncture headache and two complained of low back pain in group C, while none in group T. Incidence of post-operative nausea and vomiting in group G (10/80) was significantly higher than group T (3/80, χ = 4.10, P = 0.043) and group C (2/80, χ = 5.76, P = 0.016). No deep vein thrombosis or delayed post-operative functional exercise was detected.
CONCLUSIONS


Single subarachnoid anesthesia combined with propofol TCI seems to perform better than CSEA and GA for posterior THA in elderly patients, with less blood loss and peri-operative transfusion, higher patient satisfaction degree and fewer complications.
TRIAL REGISTRATION


chictr.org.cn: ChiCTR-IPR-17013461; http://www.chictr.org.cn/showproj.aspx?proj=23024.",2020,There were no significant differences among the three groups in terms of length of hospitalization and post-operative visual analog scale scores.,"['posterior total hip arthroplasty in elderly patients', '240 patients (aged ≥65 years, American Society of Anesthesiologists [ASA] I-III) scheduled for posterior THA were enrolled from September 1st, 2017 to March 1st, 2018', 'elderly patients', 'elderly patients in comparison with combined spinal-epidural anesthesia (CSEA) or GA']","['Intravertebral and general anesthesia (GA', 'subarachnoid anesthesia and propofol TCI', 'propofol TCI', 'subarachnoid anesthesia combined with propofol target-controlled infusion', 'CSEA', 'subarachnoid anesthesia combined with propofol target-controlled infusion (TCI', 'GA']","['intra-operative blood loss, autologous and allogeneic blood transfusion', 'length of hospitalization and post-operative visual analog scale scores', 'Length of stay in PACU', 'deep vein thrombosis or delayed post-operative functional exercise', 'blood loss and transfusion', 'mean arterial blood pressures', 'Intra-operative blood loss', 'mean arterial pressure at different time points, length of stay in post-anesthesia care unit (PACU), length of hospital stay, and patient satisfaction degree', 'low back pain', 'Incidence of post-operative nausea and vomiting', 'blood loss and peri-operative transfusion', 'quantitative index', 'blood loss and transfusion for total hip arthroplasty (THA', 'allogenetic blood transfusion']","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}]",,0.0895237,There were no significant differences among the three groups in terms of length of hospitalization and post-operative visual analog scale scores.,"[{'ForeName': 'Cheng-Shi', 'Initials': 'CS', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing 100035, China.'}, {'ForeName': 'Xiang-Dong', 'Initials': 'XD', 'LastName': 'Qu', 'Affiliation': ''}, {'ForeName': 'Zhi-Jun', 'Initials': 'ZJ', 'LastName': 'Qu', 'Affiliation': ''}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Huai-Jiang', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': ''}]",Chinese medical journal,['10.1097/CM9.0000000000000688']
910,32179526,Significant Efficacy of a Single Low Dose of Primaquine Compared to Stand-Alone Artemisinin Combination Therapy in Reducing Gametocyte Carriage in Cambodian Patients with Uncomplicated Multidrug-Resistant Plasmodium falciparum Malaria.,"Since 2012, a single low dose of primaquine (SLDPQ; 0.25 mg/kg of body weight) with artemisinin-based combination therapies has been recommended as the first-line treatment of acute uncomplicated  Plasmodium falciparum  malaria to interrupt its transmission, especially in low-transmission settings of multidrug resistance, including artemisinin resistance. Policy makers in Cambodia have been reluctant to implement this recommendation due to primaquine safety concerns and a lack of data on its efficacy. In this randomized controlled trial, 109 Cambodians with acute uncomplicated  P. falciparum  malaria received dihydroartemisinin-piperaquine (DP) alone or combined with SLDPQ on the first treatment day. The transmission-blocking efficacy of SLDPQ was evaluated on days 0, 1, 2, 3, 7, 14, 21, and 28, and recrudescence by reverse transcriptase PCR (RT-PCR) (gametocyte prevalence) and membrane feeding assays with  Anopheles minimus  mosquitoes (gametocyte infectivity). Without the influence of recrudescent infections, DP-SLDPQ reduced gametocyte carriage 3-fold compared to that achieved with DP. Of 48 patients tested on day 0, only 3 patients were infectious to mosquitoes (∼6%). Posttreatment, three patients were infectious on day 14 (3.5%, 1/29) and on the 1st and 7th days of recrudescence (8.3%, 1/12 for each); this overall low infectivity precluded our ability to assess its transmission-blocking efficacy. Our study confirms the effective gametocyte clearance of SLDPQ when combined with DP in multidrug-resistant  P. falciparum  infections and the negative impact of recrudescent infections due to poor DP efficacy. Artesunate-mefloquine (ASMQ) has replaced DP, and ASMQ-SLDPQ has been deployed to treat all patients with symptomatic  P. falciparum  infections to further support the elimination of multidrug-resistant  P. falciparum  in Cambodia. (This study has been registered at ClinicalTrials.gov under identifier NCT02434952.).",2020,"Without the influence of recrudescent infections, DP+SLDPQ reduced gametocyte carriage 3 fold compared to DP.","['109 Cambodians with acute uncomplicated  P. falciparum  malaria received', 'Cambodian patients with uncomplicated multidrug resistant  Plasmodium falciparum  malaria']","['primaquine', 'stand alone artemisinin combination therapy', 'SLDPQ', 'primaquine (SLDPQ', 'Artesunate-mefloquine (ASMQ', 'dihydroartemisinin-piperaquine (DP) alone or combined with SLDPQ']","['gametocyte carriage', 'transcriptase polymerase chain reaction (RT-PCR) (gametocyte prevalence) and membrane-feeding assays with  Anopheles minimus  mosquitoes (gametocyte infectivity']","[{'cui': 'C1553323', 'cui_str': 'Cambodians'}, {'cui': 'C0024535', 'cui_str': 'Plasmodium falciparum Malaria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone (finding)'}, {'cui': 'C1136174', 'cui_str': 'Artemisinins'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0686869', 'cui_str': 'Gametocyte'}, {'cui': 'C0035681', 'cui_str': 'RNA Polymerases'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0322934', 'cui_str': 'Anopheles minimus (organism)'}, {'cui': 'C0026584', 'cui_str': 'Mosquitoes'}, {'cui': 'C0030657', 'cui_str': 'infectivity'}]",109.0,0.0456092,"Without the influence of recrudescent infections, DP+SLDPQ reduced gametocyte carriage 3 fold compared to DP.","[{'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Vantaux', 'Affiliation': 'Malaria Molecular Epidemiology Unit, Institut Pasteur of Cambodia, Phnom Penh, Cambodia amelie.vantaux@gmail.com.'}, {'ForeName': 'Saorin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Malaria Molecular Epidemiology Unit, Institut Pasteur of Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Eakpor', 'Initials': 'E', 'LastName': 'Piv', 'Affiliation': 'Malaria Molecular Epidemiology Unit, Institut Pasteur of Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Sophy', 'Initials': 'S', 'LastName': 'Chy', 'Affiliation': 'Malaria Molecular Epidemiology Unit, Institut Pasteur of Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Berne', 'Affiliation': 'Malaria Molecular Epidemiology Unit, Institut Pasteur of Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Nimol', 'Initials': 'N', 'LastName': 'Khim', 'Affiliation': 'Malaria Molecular Epidemiology Unit, Institut Pasteur of Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Dysoley', 'Initials': 'D', 'LastName': 'Lek', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control Program, Phnom Penh, Cambodia.'}, {'ForeName': 'Sovannaroth', 'Initials': 'S', 'LastName': 'Siv', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control Program, Phnom Penh, Cambodia.'}, {'ForeName': 'Mavuto', 'Initials': 'M', 'LastName': 'Mukaka', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand.'}, {'ForeName': 'Walter R', 'Initials': 'WR', 'LastName': 'Taylor', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Ménard', 'Affiliation': 'Malaria Molecular Epidemiology Unit, Institut Pasteur of Cambodia, Phnom Penh, Cambodia.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02108-19']
911,32207134,"Comparison of Safety and Efficiency of General, Spinal and Epidural Anesthesia Methods Used for the Endoscopic Surgical Treatment of Ureteral Stones: Which One is Better To Access The Ureter and Reach The Stone?","PURPOSE


The aim of this study is to evaluate the effects of anesthesia methods on the success of urethral access and stone access achievement in endoscopic treatment of urolithiasis.
MATERIALS AND METHODS


In this prospective randomized study, 105 patients who underwent primary ureterorenoscopy (URS) procedure for ureteral stones were evaluated. The patients were randomized into three groups by permuted block randomization according to the applied anesthesia method: General anesthesia (GA): 33 patients, Spinal anesthesia (SA): 31 patients, and Epidural anesthesia (EA): 31 patients. Ten patients, whose ureteral access was not successful, were dropped out. The success of the three anesthesia methods on the success of the ureter access and its effects on surgical outcomes were compared.
RESULTS


There was no statistically significant difference among the three groups in terms of the demographic values and preoperative features except the American Society of Anesthesiologists (ASA) status. Dilatation and the access time to stone were statistically significantly longer in SA and EA group compared to the GA group. There was no statistically significant difference among the groups in terms of operation, lithotripsy time, stone-free rate (SFR), and complication rates. The Visual Analog Scale (VAS) scores in the 8th and 24th hours were statistically significantly higher in the GA group.
CONCLUSION


In patients who decided to undergo primary ureterorenoscopy procedure, it can be suggested to treat with GA to provide a better relaxation of the ureter if there are no contraindications.",2020,"There was no statistically significant difference among the groups in terms of operation, lithotripsy time, stone-free rate (SFR), and complication rates.","['Ureteral Stones', '105 patients who underwent primary URS procedure for ureteral stones were evaluated']","['anesthesia method: General anesthesia (GA): 33 patients, Spinal anesthesia (SA): 31 patients, and Epidural anesthesia (EA']","['Visual Analog Scale (VAS) scores', 'operation, lithotripsy time, stone-free rate (SFR), and complication rates', 'demographic values and preoperative features except the American Society of Anesthesiologists (ASA) status', 'Dilatation and the access time to stone']","[{'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]",105.0,0.0339014,"There was no statistically significant difference among the groups in terms of operation, lithotripsy time, stone-free rate (SFR), and complication rates.","[{'ForeName': 'Unal', 'Initials': 'U', 'LastName': 'Oztekin', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY. dr_unal@hotmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Caniklioglu', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Atac', 'Affiliation': 'Kırıkkale University, Faculty of Medicine, Department of Urology, Kırıkkale, TURKEY.'}, {'ForeName': 'Cigdem Unal', 'Initials': 'CU', 'LastName': 'Kantekin', 'Affiliation': 'Yozgat Bozok University, Faculty of Medicine, Department of Anesthesiology, Yozgat, TURKEY.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Gurel', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Isikay', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY.'}]",Urology journal,['10.22037/uj.v0i0.5638']
912,32406312,High Salt Intake Augments Blood Pressure Responses During Submaximal Aerobic Exercise.,"Background High sodium (Na + ) intake is a widespread cardiovascular disease risk factor. High Na +  intake impairs endothelial function and exaggerates sympathetic reflexes, which may augment exercising blood pressure (BP) responses. Therefore, this study examined the influence of high dietary Na +  on BP responses during submaximal aerobic exercise. Methods and Results Twenty adults (8F/12M, age=24±4 years; body mass index 23.0±0.6 kg·m -2 ; VO 2 peak=39.7±9.8 mL·min -1 ·kg -1 ; systolic BP=111±10 mm Hg; diastolic BP=64±8 mm Hg) participated in this randomized, double-blind, placebo-controlled crossover study. Total Na +  intake was manipulated via ingestion of capsules containing either a placebo (dextrose) or table salt (3900 mg Na + /day) for 10 days each, separated by ≥2 weeks. On day 10 of each intervention, endothelial function was assessed via flow-mediated dilation followed by BP measurement at rest and during 50 minutes of cycling at 60% VO 2peak . Throughout exercise, BP was assessed continuously via finger photoplethysmography and every 5 minutes via auscultation. Venous blood samples were collected at rest and during the final 10 minutes of exercise for assessment of norepinephrine. High Na +  intake increased urinary Na +  excretion (placebo=140±68 versus Na + =282±70 mmol·24H -1 ;  P <0.001) and reduced flow-mediated dilation (placebo=7.2±2.4 versus Na + =4.2±1.7%;  P <0.001). Average exercising systolic BP was augmented following high Na +  (placebo=Δ30.0±16.3 versus Na + =Δ38.3±16.2 mm Hg;  P =0.03) and correlated to the reduction in flow-mediated dilation ( R =-0.71,  P =0.002). Resting norepinephrine concentration was not different between conditions ( P =0.82). Norepinephrine increased during exercise ( P =0.002), but there was no Na +  effect ( P =0.26). Conclusions High dietary Na +  augments BP responses during submaximal aerobic exercise, which may be mediated, in part, by impaired endothelial function.",2020,High Na +  intake increased urinary Na +  excretion (placebo=140±68 versus Na + =282±70 mmol·24H -1 ;  P <0.001) and reduced flow-mediated dilation (placebo=7.2±2.4 versus Na + =4.2±1.7%;  P <0.001).,"['Hg; diastolic BP=64±8\xa0mm\xa0Hg', 'Twenty adults (8F/12M']","[' High sodium (Na + ) intake', 'Norepinephrine', 'High Na +  intake', 'placebo (dextrose) or table salt (3900', 'High Salt Intake', 'high dietary Na ', 'placebo']","['BP responses', 'endothelial function', 'endothelial function and exaggerates sympathetic reflexes', 'Venous blood samples', 'reduction in flow-mediated dilation', 'exercising blood pressure (BP) responses', 'urinary Na +  excretion', 'Resting norepinephrine concentration', 'Average exercising systolic BP', 'reduced flow-mediated dilation']","[{'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0595879', 'cui_str': 'Sodium high'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0206136', 'cui_str': 'Dietary Sodium Chloride'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0442801', 'cui_str': 'Exaggerated'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",20.0,0.259216,High Na +  intake increased urinary Na +  excretion (placebo=140±68 versus Na + =282±70 mmol·24H -1 ;  P <0.001) and reduced flow-mediated dilation (placebo=7.2±2.4 versus Na + =4.2±1.7%;  P <0.001).,"[{'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Martens', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Pescatello', 'Affiliation': 'Department of Kinesiology University of Connecticut Storrs CT.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.015633']
913,32403062,"The effect of viewing challenging ""reality check"" Instagram comments on women's body image.","One increasing trend on social media is the posting of challenging or ""reality check"" comments about idealized photos of thin and attractive women. The aim of the present study was to experimentally investigate the effect of viewing such reality check comments after a positive appearance comment on young women's body image. Participants were 192 women aged 17-25 years who were randomly assigned to view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment. In contrast to prediction, viewing positive appearance comments did not elicit more body dissatisfaction than viewing images with no comments. As predicted, however, adding a reality check comment did reduce body dissatisfaction relative to the positive appearance comment alone. It was concluded that making and viewing reality check comments provides a potential way for women to mitigate some of the negative effect of Instagram imagery.",2020,"Participants were 192 women aged 17-25 years who were randomly assigned to view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment.","[""young women's body image"", 'Participants were 192 women aged 17-25 years', ""women's body image""]","['view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment', 'viewing challenging ""reality check"" Instagram comments']",['body dissatisfaction'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}]",192.0,0.0251286,"Participants were 192 women aged 17-25 years who were randomly assigned to view Instagram images accompanied by no comment, a positive appearance comment, or a reality check comment plus the positive appearance comment.","[{'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001, Australia. Electronic address: Marika.Tiggemann@flinders.edu.au.'}, {'ForeName': 'Vasiliki Georgia', 'Initials': 'VG', 'LastName': 'Velissaris', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001, Australia.'}]",Body image,['10.1016/j.bodyim.2020.04.004']
914,32403066,A controlled clinical crossover trial of exercise training to improve cognition and neural communication in pediatric brain tumor survivors.,"OBJECTIVE


To assess the efficacy of aerobic exercise training to improve controlled attention, information processing speed and neural communication during increasing task load and rest in pediatric brain tumor survivors (PBTS) treated with cranial radiation.
METHODS


Participants completed visual-motor Go and Go/No-Go tasks during magnetoencephalography recording prior to and following the completion of 12-weeks of exercise training. Exercise-related changes in response accuracy and visual-motor latency were evaluated with Linear Mixed models. The Phase Lag Index (PLI) was used to estimate functional connectivity during task performance and rest. Changes in PLI values after exercise training were assessed using Partial Least Squares analysis.
RESULTS


Exercise training predicted sustained (12-weeks) improvement in response accuracy (p<0.05) during No-Go trials. Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials. Significant changes in response latency and resting state connectivity were not detected.
CONCLUSION


These findings support the efficacy of aerobic exercise to improve controlled attention and enhance functional mechanisms under increasing task load in participants.
SIGNIFICANCE


It may be possible to harness the beneficial effects of exercise as therapy to promote cognitive recovery and enhance brain function in PBTS.",2020,Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials.,"['pediatric brain tumor survivors (PBTS) treated with cranial radiation', 'Participants completed visual-motor Go and Go', 'pediatric brain tumor survivors']","['exercise training', 'aerobic exercise', 'Exercise training', 'aerobic exercise training']","['PLI values', 'Phase Lag Index (PLI', 'cognition and neural communication', 'response accuracy and visual-motor latency', 'response accuracy', 'Altered functional connectivity', 'response latency and resting state connectivity']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]",,0.0354978,Altered functional connectivity was detected in theta (4-7Hz) alpha (8-12Hz) and high gamma (60-100Hz) frequency bands (p<0.001) during Go and Go/No-Go trials.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: elizabeth.cox@sickkids.ca.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Bells', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: sonya.bells@sickkids.ca.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Timmons', 'Affiliation': 'Department of Pediatrics, McMaster University, 1200 Main Street W., Hamilton, ON L8N 3Z5, Canada. Electronic address: timmonbw@mcmaster.ca.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Laughlin', 'Affiliation': 'Diagnostic Imaging, SickKids, 555 University Avenue, Toronto, ON M5G 1X8, Canada. Electronic address: suzanne.laughlin@sickkids.ca.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bouffet', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: eric.bouffet@sickkids.ca.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'de Medeiros', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: cynthia.demedeiros@sickkids.ca.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Beera', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: kirangbeera@gmail.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Harasym', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: harasyd@mcmaster.ca.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Mabbott', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: donald.mabbott@sickkids.ca.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.03.027']
915,32403115,Delayed iron does not alter cognition or behavior among children with severe malaria and iron deficiency.,"BACKGROUND


Malaria and iron deficiency (ID) in childhood are both associated with cognitive and behavioral dysfunction. The current standard of care for children with malaria and ID is concurrent antimalarial and iron therapy. Delaying iron therapy until inflammation subsides could increase iron absorption but also impair cognition.
METHODS


In this study, Ugandan children 18 months to 5 years old with cerebral malaria (CM, n = 79), severe malarial anemia (SMA, n = 77), or community children (CC, n = 83) were enrolled and tested for ID. Children with ID were randomized to immediate vs. 28-day delayed iron therapy. Cognitive and neurobehavioral outcomes were assessed at baseline and 6 and 12 months (primary endpoint) after enrollment.
RESULTS


All children with CM or SMA and 35 CC had ID (zinc protoporphyrin concentration ≥80 μmol/mol heme). No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
CONCLUSIONS


Children with CM or SMA and ID who received immediate vs. delayed iron therapy had similar cognitive and neurobehavioral outcomes at 12-month follow-up.
IMPACT


The optimal time to provide iron therapy in children with severe malaria is not known. The present study shows that delay of iron treatment to 28 days after the malaria episode, does not lead to worse cognitive or behavioral outcomes at 12-month follow-up.The study contributes new data to the ongoing discussion of how best to treat ID in children with severe malaria.",2020,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
","['children with severe malaria and iron deficiency', 'Ugandan children 18 months to 5 years old with cerebral malaria (CM, n\u2009=\u200979), severe malarial anemia (SMA, n\u2009=\u200977), or community children (CC, n\u2009=\u200983) were enrolled and tested for ID', 'Children with ID', 'children with severe malaria']",['immediate vs. 28-day delayed iron therapy'],"['cognitive and neurobehavioral outcomes', 'Cognitive and neurobehavioral outcomes', 'cognition or behavior', 'cognitive or behavioral outcomes', 'overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2747816', 'cui_str': 'Complicated malaria'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0024534', 'cui_str': 'Cerebral malaria'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",83.0,0.106877,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Ssemata', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Hickson', 'Affiliation': ""Division of General Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Ssenkusu', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cusick', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Noeline', 'Initials': 'N', 'LastName': 'Nakasujja', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Pediatrics and Child Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kroupina', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Georgieff', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bangirana', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Chandy C', 'Initials': 'CC', 'LastName': 'John', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA. chjohn@iu.edu.'}]",Pediatric research,['10.1038/s41390-020-0957-8']
916,32403118,Proof of mechanism and target engagement of glutamatergic drugs for the treatment of schizophrenia: RCTs of pomaglumetad and TS-134 on ketamine-induced psychotic symptoms and pharmacoBOLD in healthy volunteers.,"Glutamate neurotransmission is a prioritized target for antipsychotic drug development. Two metabotropic glutamate receptor 2/3 (mGluR2/3) agonists (pomaglumetad [POMA] and TS-134) were assessed in two Phase Ib proof of mechanism studies of comparable designs and using identical clinical assessments and pharmacoBOLD methodology. POMA was examined in a randomized controlled trial under double-blind conditions for 10-days at doses of 80 or 320 mg/d POMA versus placebo (1:1:1 ratio). The TS-134 trial was a randomized, single-blind, 6-day study of 20 or 60 mg/d TS-134 versus placebo (5:5:2 ratio). Primary outcomes were ketamine-induced changes in pharmacoBOLD in the dorsal anterior cingulate cortex (dACC) and symptoms reflected on the Brief Psychiatric Rating Scale (BPRS). Both trials were conducted contemporaneously. 95 healthy volunteers were randomized to POMA and 63 to TS-134. High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d = -0.41; p = 0.04, d = -0.44, respectively), but neither POMA dose significantly suppressed ketamine-induced dACC pharmacoBOLD. In contrast, low-dose TS-134 led to moderate to large within and between group reductions in both BPRS positive symptoms (p = 0.02, d = -0.36; p = 0.008, d = -0.82, respectively) and dACC pharmacoBOLD (p = 0.004, d = -0.56; p = 0.079, d = -0.50, respectively) using pooled across-study placebo data. High-dose POMA exerted significant effects on clinical symptoms, but not on target engagement, suggesting a higher dose may yet be needed, while the low dose of TS-134 showed evidence of symptom reduction and target engagement. These results support further investigation of mGluR2/3 and other glutamate-targeted treatments for schizophrenia.",2020,"High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d ","['healthy volunteers', '95 healthy volunteers']","['POMA versus placebo', 'TS-134 versus placebo', 'Two metabotropic glutamate receptor 2/3 (mGluR2/3) agonists (pomaglumetad [POMA] and TS-134', 'ketamine']","['BPRS positive symptoms', 'dACC pharmacoBOLD', 'BPRS total symptoms', 'clinical symptoms', 'ketamine-induced changes in pharmacoBOLD in the dorsal anterior cingulate cortex (dACC) and symptoms reflected on the Brief Psychiatric Rating Scale (BPRS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1098057', 'cui_str': 'poly(n-octyl methacrylate)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0206529', 'cui_str': 'Metabotropic Glutamate Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}]",95.0,0.504117,"High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d ","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grinband', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Goff', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY, USA.'}, {'ForeName': 'Adrienne C', 'Initials': 'AC', 'LastName': 'Lahti', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Marder', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Ragy R', 'Initials': 'RR', 'LastName': 'Girgis', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sobeih', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Green', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Yvonne S', 'Initials': 'YS', 'LastName': 'Yang', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Junghee', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Horga', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Potter', 'Affiliation': 'National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Columbia University, New York, NY, USA. Jeffrey.Lieberman@nyspi.columbia.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0706-z']
917,32404181,Reducing sitting at work: process evaluation of the SMArT Work (Stand More At Work) intervention.,"BACKGROUND


Office-based workers accumulate high amounts of sitting time. Stand More At Work (SMArT Work) aimed to reduce occupational sitting time and a cluster randomised controlled trial demonstrated it was successful in achieving this aim. The purpose of this paper is to present the process evaluation of the SMArT Work intervention.
METHODS


Questionnaire data were collected from intervention participants at 6 months (n = 58) and 12 months (n = 55). Questionnaires sought feedback on the different components of the intervention (education, height-adjustable desk, Darma cushion, behaviour feedback, progress chats (coaching) with research team, action planning/goal setting diary) and experiences of evaluation measures. Control participants (n = 37) were asked via questionnaire at 12-month follow-up about the impact of the study on their behaviour and any lifestyle changes made during the study. Participants from both arms were invited to focus groups to gain a deeper understanding of their experiences on completion of 12-month follow-up.
RESULTS


Focus group and questionnaire data showed a positive attitude towards the height-adjustable workstation with a high proportion of participants using it every day (62%). Most participants (92%) felt the education seminar increased their awareness of the health consequences of too much sitting and motivated them to change their behaviour. Receiving feedback on their sitting time and support from the research team also encouraged behaviour change. The Darma cushion and action planning/goal setting diary were seen to be less helpful for behaviour change. Benefits experienced included fewer aches and pains, improved cognitive functioning, increased productivity, more energy and positive feelings about general health.
CONCLUSIONS


Key elements of the programme identified as facilitating behaviour change were the educational seminar, the height-adjustable workstation, behavioural feedback and regular contact with research staff through regular progress chats.
TRIAL REGISTRATION


ISRCTN: ISRCTN10967042. Registered on 2 February 2015.",2020,"Benefits experienced included fewer aches and pains, improved cognitive functioning, increased productivity, more energy and positive feelings about general health.
","['Control participants (n\u2009=\u200937', 'Questionnaire data were collected from intervention participants at 6 months (n\u2009=\u200958) and 12\u2009months (n\u2009=\u200955']",[],"['aches and pains, improved cognitive functioning, increased productivity, more energy and positive feelings about general health']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0001044', 'cui_str': 'Acetylcholinesterase'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}]",,0.0323989,"Benefits experienced included fewer aches and pains, improved cognitive functioning, increased productivity, more energy and positive feelings about general health.
","[{'ForeName': 'Stuart J H', 'Initials': 'SJH', 'LastName': 'Biddle', 'Affiliation': 'Centre for Health Research, University of Southern Queensland, Springfield,, QLD, 4300, Australia.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': ""O'Connell"", 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK. ce95@le.ac.uk.'}, {'ForeName': 'Dale W', 'Initials': 'DW', 'LastName': 'Esliger', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, LE5 4PW, UK.'}, {'ForeName': 'Fehmidah', 'Initials': 'F', 'LastName': 'Munir', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}]",Trials,['10.1186/s13063-020-04300-7']
918,32404378,Effect of high-salt diet on blood pressure and body fluid composition in patients with type 1 diabetes: randomized controlled intervention trial.,"INTRODUCTION


Patients with type 1 diabetes are susceptible to hypertension, possibly resulting from increased salt sensitivity and accompanied changes in body fluid composition. We examined the effect of a high-salt diet (HSD) in type 1 diabetes on hemodynamics, including blood pressure (BP) and body fluid composition.
RESEARCH DESIGN AND METHODS


We studied eight male patients with type 1 diabetes and 12 matched healthy controls with normal BP, body mass index, and renal function. All subjects adhered to a low-salt diet and HSD for eight days in randomized order. On day 8 of each diet, extracellular fluid volume (ECFV) and plasma volume were calculated with the use of iohexol and  125 I-albumin distribution. Hemodynamic measurements included BP, cardiac output (CO), and systemic vascular resistance.
RESULTS


After HSD, patients with type 1 diabetes showed a BP increase (mean arterial pressure: 85 (5) mm Hg vs 80 (3) mm Hg; p<0.05), while BP in controls did not rise (78 (5) mm Hg vs 78 (5) mm Hg). Plasma volume increased after HSD in patients with type 1 diabetes (p<0.05) and not in controls (p=0.23). There was no significant difference in ECFV between diets, while HSD significantly increased CO, heart rate (HR) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) in type 1 diabetes but not in controls. There were no significant differences in systemic vascular resistance, although there was a trend towards an HSD-induced decrease in controls (p=0.09).
CONCLUSIONS


In the present study, patients with type 1 diabetes show a salt-sensitive BP rise to HSD, which is accompanied by significant increases in plasma volume, CO, HR, and NT-proBNP. Underlying mechanisms for these responses need further research in order to unravel the increased susceptibility to hypertension and cardiovascular disease in diabetes.
TRIAL REGISTRATION NUMBERS


NTR4095 and NTR4788.",2020,"There were no significant differences in systemic vascular resistance, although there was a trend towards an HSD-induced decrease in controls (p=0.09).
","['eight male patients with type 1 diabetes and 12 matched healthy controls with normal BP, body mass index, and renal function', 'patients with type 1 diabetes']","['high-salt diet', 'high-salt diet (HSD', 'iohexol']","['BP, cardiac output (CO), and systemic vascular resistance', 'BP increase (mean arterial pressure', 'plasma volume, CO, HR, and NT-proBNP', 'blood pressure and body fluid composition', 'systemic vascular resistance', 'ECFV', 'Plasma volume', 'blood pressure (BP) and body fluid composition', 'CO, heart rate (HR) and N-terminal pro-B-type natriuretic peptide (NT-proBNP', 'extracellular fluid volume (ECFV) and plasma volume']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015349', 'cui_str': 'Extracellular fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",8.0,0.034718,"There were no significant differences in systemic vascular resistance, although there was a trend towards an HSD-induced decrease in controls (p=0.09).
","[{'ForeName': 'Eliane F E', 'Initials': 'EFE', 'LastName': 'Wenstedt', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Nienke M G', 'Initials': 'NMG', 'LastName': 'Rorije', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Rik H G', 'Initials': 'RHG', 'LastName': 'Olde Engberink', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'van der Molen', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Chahid', 'Affiliation': 'Department of Pharmacy, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'A H Jan', 'Initials': 'AHJ', 'LastName': 'Danser', 'Affiliation': 'Department of Internal Medicine, Erasmus MC, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Bert-Jan H', 'Initials': 'BH', 'LastName': 'van den Born', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC - Locatie AMC, Amsterdam, North Holland, Netherlands l.vogt@amsterdamumc.nl.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-001039']
919,32404389,Focus group discussions on low-flow oxygen and bubble CPAP treatments among mothers of young children in Malawi: a CPAP IMPACT substudy.,"OBJECTIVE


To determine the acceptability of bubble continuous positive airway pressure (bCPAP) and low-flow oxygen among mothers of children who had received either therapy.
SETTING


A district hospital in Salima, Malawi.
PARTICIPANTS


We conducted eight focus group discussions (FGDs) with a total of 54 participants. Eligible participants were mothers of children 1 to 59 months of age with severe pneumonia and a comorbidity (HIV-infection, HIV-exposure, malnutrition or hypoxaemia) who, with informed consent, had been enrolled in a randomised clinical trial, CPAP IMPACT (Improving Mortality for Pneumonia in African Children Trial), comparing low-flow oxygen and bCPAP treatments (ClinicalTrials.gov, NCT02484183).
PRIMARY AND SECONDARY OUTCOME MEASURES


FGDs assessed mothers' attitudes and feelings towards oxygen and bCPAP before and after therapy along with general community perceptions of respiratory therapies. Data was analysed using inductive thematic analysis to assess themes and subthemes of the transcripts.
RESULTS


Community perceptions of oxygen and bCPAP were widely negative. Mothers recounted that they are told that 'oxygen kills babies'. They are often fearful of allowing their child to receive oxygen therapy and will delay treatment or seek alternative therapies. Mothers report limiting oxygen and bCPAP by intermittently removing the nasal cannulas or mask. After oxygen or bCPAP treatment, regardless of patient outcome, mothers were supportive of the treatment their child received and would recommend it to other mothers.
CONCLUSION


There are significant community misconceptions around oxygen and bCPAP causing mothers to be fearful of either treatment. In order for low-flow oxygen treatment and bCPAP implementation to be effective, widespread community education is necessary.",2020,"After oxygen or bCPAP treatment, regardless of patient outcome, mothers were supportive of the treatment their child received and would recommend it to other mothers.
","['mothers of children who had received either therapy', 'We conducted eight focus group discussions (FGDs) with a total of 54 participants', 'A district hospital in Salima, Malawi', 'Eligible participants were mothers of children 1 to 59 months of age with severe pneumonia and a comorbidity (HIV-infection, HIV-exposure, malnutrition or hypoxaemia) who, with informed consent', 'mothers of young children in Malawi']","['bubble continuous positive airway pressure (bCPAP) and low-flow oxygen', 'bCPAP', 'CPAP IMPACT', 'low-flow oxygen and bubble CPAP treatments']","[""FGDs assessed mothers' attitudes and feelings towards oxygen and bCPAP""]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205454', 'cui_str': '8'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]",54.0,0.106875,"After oxygen or bCPAP treatment, regardless of patient outcome, mothers were supportive of the treatment their child received and would recommend it to other mothers.
","[{'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Sessions', 'Affiliation': 'Pediatrics, McGaw Medical Center of Northwestern University, Chicago, Illinois, United States ksessions@luriechildrens.org.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ruegsegger', 'Affiliation': 'Project Malawi, University of North Carolina System, Lilongwe, Malawi.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Davie', 'Initials': 'D', 'LastName': 'Kondowe', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Mercy', 'Initials': 'M', 'LastName': 'Tsidya', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Lufesi', 'Affiliation': 'Acute Respiratory Infection Unit, Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Eckerle', 'Affiliation': ""Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States.""}, {'ForeName': 'Andrew Gerald', 'Initials': 'AG', 'LastName': 'Smith', 'Affiliation': 'Pediatric Critical Care Medicine, University of Utah, Salt Lake City, Utah, United States.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Eudowood Division of Pediatric Respiratory Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland, United States.'}]",BMJ open,['10.1136/bmjopen-2019-034545']
920,32404390,Effects of an automated digital brief prevention intervention targeting adolescents and young adults with risky alcohol and other substance use: study protocol for a randomised controlled trial.,"INTRODUCTION


Adolescence and young adulthood is a period in life when individuals may be especially vulnerable to harmful substance use. Several critical developmental processes are occurring in the brain, and substance use poses both short-term and long-term risks with regard to mental health and social development. From a public health perspective, it is important to prevent or delay substance use to reduce individual risk and societal costs. Given the scarcity of effective interventions targeting substance use among adolescents and young adults, cost-effective and easily disseminated interventions are warranted. The current study will test the effectiveness of a fully automated digital brief intervention aimed at reducing alcohol and other substance use in adolescents and young adults aged 15 to 25 years.
METHODS AND ANALYSIS


A two-arm, double-blind, randomised controlled trial design is applied to assess the effectiveness of the intervention. Baseline assessment, as well as 3-month and 6-month follow-up, will be carried out. The aim is to include 800 participants with risky substance use based on the screening tool CRAFFT (Car,Relax, Alone, Forget, Friends, Trouble). Recruitment, informed consent, randomisation, intervention and follow-up will be implemented online. The primary outcome is reduction in alcohol use, measured by Alcohol Use Disorders Identification Test total score. Secondary outcomes concern binge drinking, frequency of alcohol consumption, amount of alcohol consumed a typical day when alcohol is consumed, average daily drinks per typical week, other substance use, mental health, sexual risk behaviours and perceived peer pressure. Moreover, the study involves analyses of potential moderators including perfectionism, openness to parents, help-seeking and background variables.
ETHICS AND DISSEMINATION


The study was approved by the Swedish Ethical Review Authority (no. 2019-03249). The trial is expected to expand the knowledge on digital preventive interventions for substance using adolescents and young adults. Results will be disseminated in research journals, at conferences and via the media.
TRIAL REGISTRATION NUMBER


24 September 2019, ISRCTN91048246; Pre-results.",2020,"The current study will test the effectiveness of a fully automated digital brief intervention aimed at reducing alcohol and other substance use in adolescents and young adults aged 15 to 25 years.
","['adolescents and young adults aged 15 to 25 years', 'substance using adolescents and young adults', 'adolescents and young adults', 'adolescents and young adults with risky alcohol and other substance use', '800 participants with risky substance use based on the screening tool CRAFFT (Car,Relax, Alone, Forget, Friends, Trouble']",['automated digital brief prevention intervention'],"['binge drinking, frequency of alcohol consumption, amount of alcohol consumed a typical day when alcohol is consumed, average daily drinks per typical week, other substance use, mental health, sexual risk behaviours and perceived peer pressure', 'reduction in alcohol use, measured by Alcohol Use Disorders Identification Test total score']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0079382', 'cui_str': 'Friend'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0562366', 'cui_str': 'Pressured by peers'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",800.0,0.0827623,"The current study will test the effectiveness of a fully automated digital brief intervention aimed at reducing alcohol and other substance use in adolescents and young adults aged 15 to 25 years.
","[{'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Kvillemo', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden pia.kvillemo@ki.se.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Strandberg', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gripenberg', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Berman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Skoglund', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Tobias H', 'Initials': 'TH', 'LastName': 'Elgán', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-034894']
921,32404430,Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial.,"OBJECTIVES


To investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery.
DESIGN


Open, multicentre, randomised, controlled, non-inferiority trial.
SETTING


Seven National Health Service tertiary hospitals in the United Kingdom.
PARTICIPANTS


1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate.
INTERVENTION


Participants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS.
OUTCOME MEASURES


The primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality.
RESULTS


Between May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval -0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be non-inferior.
CONCLUSIONS


For patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery.
TRIAL REGISTRATION


ISRCTN13911492.",2020,"Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be","['1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate', 'patients who have elective surgery and are at moderate or high risk of venous thromboembolism', 'patients undergoing elective surgery', 'Seven National Health Service tertiary hospitals in the United Kingdom', '1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery', 'elective surgical patients (GAPS study', 'Between May 2016 and January 2019, 1905 participants were randomised']","['low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS', 'LMWH', 'Graduated compression stockings', 'graduated compression stockings (GCS', 'GCS']","['imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms', 'quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0340708', 'cui_str': 'Deep venous thrombosis of lower extremity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0445269', 'cui_str': 'Socks'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1905.0,0.261781,"Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Shalhoub', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lawton', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Department of Cardiology, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bradbury', 'Affiliation': 'University of Birmingham & University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dhillon', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Everington', 'Affiliation': 'Hampshire Hospitals NHS Foundation Trust, Hampshire, UK.'}, {'ForeName': 'Manjit S', 'Initials': 'MS', 'LastName': 'Gohel', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Zaed', 'Initials': 'Z', 'LastName': 'Hamady', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Beverley J', 'Initials': 'BJ', 'LastName': 'Hunt', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Gerrard', 'Initials': 'G', 'LastName': 'Stansby', 'Affiliation': 'Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Warwick', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alun H', 'Initials': 'AH', 'LastName': 'Davies', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK a.h.davies@imperial.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m1309']
922,32405757,Attention-enhancing effects of propranolol and synergistic effects with nicotine.,"Nicotine increases the output of every major neurotransmitter. In previous studies designed to identify the secondary neurotransmitter systems mediating nicotine's attention-enhancing effects in a rat model, the β-adrenoceptor antagonist propranolol blocked these effects. The present study was designed to test whether this mechanism held true in humans, thus guiding development of novel nicotinic agonists for cognitive enhancement. Twenty-six nonsmokers completed a nicotine (7 mg/24 h transdermally) x propranolol (40 mg p.o., body weight-adjusted) interaction study. Over four test days, each participant received double-placebo, nicotine only, propranolol only, and nicotine plus propranolol in randomized sequence before cognitive testing. No drug effects were seen in a visuospatial attention task. In the Rapid Visual Information Processing Task, performed in two 15-min blocks, neither drug alone significantly affected hit rate, but both drugs combined acted synergistically to alleviate its decrement over time in the first block and displayed additive beneficial effects in the second. In a change detection task, propranolol enhanced accuracy and reduced reaction time independent of nicotine presence. Propranolol also enhanced subjective self-reports of vigor. Overall, the findings were contrary to those hypothesized. Propranolol displayed beneficial effects on cognition, especially on sustaining performance over time. β-adrenoceptor activation by nicotine-induced noradrenaline release appeared to limit performance-enhancing effects of nicotine, because they were unmasked by β-adrenoceptor antagonism. The results suggest that cognitive effects of changes in β-adrenoceptor tone are context-dependent; contrary to rodent paradigms, human cognitive paradigms require no physical orienting in space but prolonged periods of remaining stationary while sustaining predictable processing demands.",2020,"In the Rapid Visual Information Processing Task, performed in two 15-min blocks, neither drug alone significantly affected hit rate, but both drugs combined acted synergistically to alleviate its decrement over time in the first block and displayed additive beneficial effects in the second.",['Twenty-six nonsmokers completed a nicotine (7 mg/24 h transdermally'],"['double-placebo, nicotine only, propranolol only, and nicotine plus propranolol', 'nicotine', 'Nicotine', 'Propranolol', 'propranolol']","['visuospatial attention task', 'output of every major neurotransmitter']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}]",,0.0267626,"In the Rapid Visual Information Processing Task, performed in two 15-min blocks, neither drug alone significantly affected hit rate, but both drugs combined acted synergistically to alleviate its decrement over time in the first block and displayed additive beneficial effects in the second.","[{'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA. bhahn@som.umaryland.edu.'}, {'ForeName': 'Cory K', 'Initials': 'CK', 'LastName': 'Olmstead', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}, {'ForeName': 'Marie B', 'Initials': 'MB', 'LastName': 'Yuille', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Chiappelli', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}, {'ForeName': 'Ashleigh K', 'Initials': 'AK', 'LastName': 'Wells', 'Affiliation': 'Department of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine, P.O. Box 21247, Baltimore, MD, 21228, USA.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-020-00794-5']
923,32401905,Prevention of alcohol consumption and transmission of human immunodeficiency virus: randomized clinical trial.,"OBJECTIVE


to know the effects of a nursing intervention to reduce alcohol use and risk factors for transmission of human immunodeficiency virus (HIV).
METHOD


randomized single-blinded clinical trial performed by nurses with young women. The study included 66 participants in the intervention group and 66 participants in the control group. The instruments were the Alcohol Use Disorders Identification Test, the HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale. Analysis of variance was used.
RESULTS


alcohol involvement decreased in the intervention group (F (1.119) = 50.28; p < 0.001; η2p = 0.297), while HIV knowledge (F (1.130) = 34.34; p < 0.001; η2p = 0.209) and condom use self-efficacy increased (F (1.129) = 27.20; p < 0.001; η2p = 0.174). In addition, less participants consumed alcohol in the past week compared to the control group (χ2 = 15.95; p < 0.001).
CONCLUSION


the nursing intervention had positive effects, which could help young women stay away from alcohol use and the risk of sexually transmitted infections. NCT: 02405481.",2020,"The instruments were the Alcohol Use Disorders Identification Test, the HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale.","['human immunodeficiency virus', '66 participants in the intervention group and 66 participants in the control group', 'nurses with young women']","['NCT', 'nursing intervention']","['HIV knowledge', 'condom use self-efficacy', 'HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",66.0,0.0506514,"The instruments were the Alcohol Use Disorders Identification Test, the HIV Risk Behavior Knowledge and the Condom Use Self-efficacy Scale.","[{'ForeName': 'Martha Dalila', 'Initials': 'MD', 'LastName': 'Mendez-Ruiz', 'Affiliation': 'Facultad de Enfermería de Nuevo Laredo, Universidad Autónoma de Tamaulipas, Nuevo Laredo, Tamaulipas, Mexico.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Villegas-Pantoja', 'Affiliation': 'Facultad de Enfermería de Nuevo Laredo, Universidad Autónoma de Tamaulipas, Nuevo Laredo, Tamaulipas, Mexico.'}, {'ForeName': 'Nohemí Selene', 'Initials': 'NS', 'LastName': 'Alarcón-Luna', 'Affiliation': 'Facultad de Enfermería de Nuevo Laredo, Universidad Autónoma de Tamaulipas, Nuevo Laredo, Tamaulipas, Mexico.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Villegas', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, Florida, United States of America.'}, {'ForeName': 'Rosina', 'Initials': 'R', 'LastName': 'Cianelli', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, Florida, United States of America.'}, {'ForeName': 'Nilda', 'Initials': 'N', 'LastName': 'Peragallo-Montano', 'Affiliation': 'Chapel Hill School of Nursing, University of North Carolina, Chapel Hill, North Carolina, United States of America.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3393.3262']
924,30280635,Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer.,"BACKGROUND


Standard first-line therapy for metastatic, squamous non-small-cell lung cancer (NSCLC) is platinum-based chemotherapy or pembrolizumab (for patients with programmed death ligand 1 [PD-L1] expression on ≥50% of tumor cells). More recently, pembrolizumab plus chemotherapy was shown to significantly prolong overall survival among patients with nonsquamous NSCLC.
METHODS


In this double-blind, phase 3 trial, we randomly assigned, in a 1:1 ratio, 559 patients with untreated metastatic, squamous NSCLC to receive 200 mg of pembrolizumab or saline placebo for up to 35 cycles; all the patients also received carboplatin and either paclitaxel or nanoparticle albumin-bound [nab]-paclitaxel for the first 4 cycles. Primary end points were overall survival and progression-free survival.
RESULTS


After a median follow-up of 7.8 months, the median overall survival was 15.9 months (95% confidence interval [CI], 13.2 to not reached) in the pembrolizumab-combination group and 11.3 months (95% CI, 9.5 to 14.8) in the placebo-combination group (hazard ratio for death, 0.64; 95% CI, 0.49 to 0.85; P<0.001). The overall survival benefit was consistent regardless of the level of PD-L1 expression. The median progression-free survival was 6.4 months (95% CI, 6.2 to 8.3) in the pembrolizumab-combination group and 4.8 months (95% CI, 4.3 to 5.7) in the placebo-combination group (hazard ratio for disease progression or death, 0.56; 95% CI, 0.45 to 0.70; P<0.001). Adverse events of grade 3 or higher occurred in 69.8% of the patients in the pembrolizumab-combination group and in 68.2% of the patients in the placebo-combination group. Discontinuation of treatment because of adverse events was more frequent in the pembrolizumab-combination group than in the placebo-combination group (13.3% vs. 6.4%).
CONCLUSIONS


In patients with previously untreated metastatic, squamous NSCLC, the addition of pembrolizumab to chemotherapy with carboplatin plus paclitaxel or nab-paclitaxel resulted in significantly longer overall survival and progression-free survival than chemotherapy alone. (Funded by Merck Sharp & Dohme; KEYNOTE-407 ClinicalTrials.gov number, NCT02775435 .).",2018,"The median progression-free survival was 6.4 months (95% CI, 6.2 to 8.3) in the pembrolizumab-combination group and 4.8 months (95% CI, 4.3 to 5.7) in the placebo-combination group (hazard ratio for disease progression or death, 0.56; 95% CI, 0.45 to 0.70; P<0.001).","['559 patients with untreated metastatic, squamous NSCLC to receive 200 mg of', 'Squamous Non-Small-Cell Lung Cancer']","['platinum-based chemotherapy or pembrolizumab', 'pembrolizumab or saline placebo', 'carboplatin plus paclitaxel or nab-paclitaxel', 'Pembrolizumab plus Chemotherapy', 'carboplatin and either paclitaxel or nanoparticle albumin-bound [nab]-paclitaxel', 'pembrolizumab plus chemotherapy']","['overall survival and progression-free survival', 'Adverse events of grade 3 or higher', 'median progression-free survival', 'adverse events', 'overall survival benefit', 'median overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C1961039', 'cui_str': 'paclitaxel protein-bound'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",559.0,0.754216,"The median progression-free survival was 6.4 months (95% CI, 6.2 to 8.3) in the pembrolizumab-combination group and 4.8 months (95% CI, 4.3 to 5.7) in the placebo-combination group (hazard ratio for disease progression or death, 0.56; 95% CI, 0.45 to 0.70; P<0.001).","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tafreshi', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gümüş', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazières', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hermes', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Çay Şenler', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Csőszi', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fülöp', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Jerónimo', 'Initials': 'J', 'LastName': 'Rodríguez-Cid', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Halmos', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Lubiniecki', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': 'Dariusz M', 'Initials': 'DM', 'LastName': 'Kowalski', 'Affiliation': 'From Hospital Universitario 12 de Octubre, Spanish National Cancer Research Center, Universidad Complutense and Ciberonc, Madrid (L.P.-A.), and Hospital Universitario Virgen Macarena, Seville (D.V.) - both in Spain; Leningrad Regional Clinical Hospital, St. Petersburg, Russia (A.L.); Wollongong Oncology and Wollongong Private Hospital, Wollongong, NSW, Australia (A.T.); Istanbul Medeniyet University Hospital, Istanbul (M.G.), and Ankara University, Ankara (F.Ç.Ş.) - both in Turkey; Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France (J.M.); Universitätsklinikum Tübingen, Tübingen, Germany (B. Hermes); Jász-Nagykun-Szolnok County Hospital, Szolnok (T.C.), and Országos Korányi TBC és Pulmonológiai Intézet, Budapest (A.F.) - both in Hungary; Oncology Center, Medica Sur Hospital, Mexico City (J.R.-C.); Humber River Regional Hospital, Toronto (J.W.); Sendai Kousei Hospital, Sendai (S.S.), and the Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju, South Korea (K.H.L.); Jilin Cancer Hospital, Changchun, China (Y.C.); University of Turin, Orbassano, Italy (S.N.); Montefiore Medical Center-Albert Einstein College of Medicine, New York (B. Halmos); Merck, Kenilworth, NJ (X.L., G.M.L., B.P.); and the Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (D.M.K.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1810865']
925,32200512,Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials.,"INTRODUCTION


Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for treatment of moderate-to-severe plaque psoriasis. Our objective was to evaluate the long-term efficacy and safety of ixekizumab in moderate-to-severe plaque psoriasis through 5 years.
METHODS


Data were integrated from the UNCOVER-1 and UNCOVER-2, randomized, double-blinded, phase-3 trials. Patients who continuously received the labeled ixekizumab dose, were static Physician's Global Assessment (sPGA) (0,1) responders at Week 12 and completed 60 weeks of treatment could enter the long-term extension (LTE) period. Patients could escalate to every-2-week dosing per investigator opinion. Efficacy and health outcomes included proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75/90/100, sPGA (0,1) and (0), absolute PASI ≤ 5/ ≤ 3/ ≤ 2/ ≤ 1 and Dermatology Life Quality Index (DLQI) (0,1). Results exclude patients who escalated to every-2-week dosing. A modified non-responder imputation method was used to account for missing data. Supplemental analyses include patients who escalated to every-2-week dosing and observed and multiple imputation results. Exposure-adjusted safety outcomes are also reported.
RESULTS


Of 206 patients who entered the LTE periods, 172 completed treatment. At Week 60, PASI 75/90/100 responses were 94.7%, 85.0% and 62.1%, respectively, and at year 5 were 90.3%, 71.3% and 46.3%, respectively. Similarly, meaningful responses were achieved for the other efficacy and health measures. Among patients with PASI 100 through 5 years, 92% achieved DLQI (0,1), indicating no impact of skin disease on quality of life. During the LTE period, exposure-adjusted incidence rates were 31.4 per 100 patient-years for treatment-emergent adverse events and 6.8 per 100 patient-years for serious adverse events. No deaths were reported. No new or unexpected safety findings were noted.
CONCLUSIONS


The results demonstrate 80 mg ixekizumab maintains long-term efficacy and a safety profile consistent with previous data in patients with moderate-to-severe plaque psoriasis through 5 years of treatment.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, UNCOVER-1: NCT01474512, UNCOVER-2: NCT01597245.",2020,"No new or unexpected safety findings were noted.
","['206 patients who entered the LTE periods, 172 completed treatment', 'moderate-to-severe plaque psoriasis through 5\xa0years', 'patients with moderate-to-severe plaque psoriasis through 5\xa0years of treatment', 'Through 5 Years in Moderate-to-Severe Psoriasis']","['ixekizumab', 'Ixekizumab', ""labeled ixekizumab dose, were static Physician's Global Assessment (sPGA""]","['exposure-adjusted incidence rates', 'Efficacy and Safety', 'PASI 75/90/100 responses', 'quality of life', 'proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75/90/100, sPGA (0,1) and (0), absolute PASI\u2009≤\u20095', 'Dermatology Life Quality Index (DLQI) (0,1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}]",206.0,0.0947104,"No new or unexpected safety findings were noted.
","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology, St. Louis, MO, USA.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ""St. Vincent's Hospital Melbourne and Probity Medical Research, Skin Health Institute, The University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Hideshi', 'Initials': 'H', 'LastName': 'Torii', 'Affiliation': 'Division of Dermatology, Tokyo Yamate Medical Center, Tokyo, Japan.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Gerdes', 'Affiliation': 'Psoriasis-Center at the Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Guenther', 'Affiliation': 'Guenther Dermatology Research Centre, London, ON, Canada.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'SkiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Ferris', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Christopher E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester, UK.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'ElMaraghy', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Crane', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'Burge', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shrom', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA. shrom_david_stanley@lilly.com.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Leung', 'Affiliation': 'Syneos Health, Morrisville, NC, USA.'}, {'ForeName': 'Chen-Yen', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research and Probity Medical Research Inc., Waterloo, ON, Canada.'}]",Dermatology and therapy,['10.1007/s13555-020-00367-x']
926,32068603,Vascular endothelial growth factor concentration in vitreous humor of patients with severe proliferative diabetic retinopathy after intravitreal injection of conbercept as an adjunctive therapy for vitrectomy.,"BACKGROUND


Proliferative diabetic retinopathy (PDR) is a progressive stage of diabetic retinopathy featured by the formation of neovascular and proliferative membrane. Vascular endothelial growth factor (VEGF) acts as a pivot factor in the development of neovascularization. This study was to investigate the changes of intravitreal VEGF concentrations of severe PDR after intravitreal injection of conbercept (IVC) and its potential advantages to the following vitrectomy.
METHODS


This was a prospective, interventional, randomized controlled study. Sixty eyes (60 patients) with severe PDR and 20 eyes from 20 patients with rhegmatogenous retinal detachment complicated with proliferative vitreoretinopathy were enrolled in this study. PDR eyes were randomly assigned to three groups by sortation randomization method with 20 eyes in each based on the interval of preoperative IVC (group A: 7 days, group B: 14 days, group C: non-IVC). Another 20 eyes without diabetes were enrolled as the non-diabetic control group (group D), receiving PPV directly. Vitreous specimens of all 80 patients were collected and evaluated afterwards. The intravitreal VEGF concentration of the four groups, and the total surgical time and the intraoperative bleeding rate of the PDR groups were recorded.
RESULTS


The mean intravitreal VEGF concentrations of groups A-D were 66.6 ± 43.3, 93.1 ± 52.3, 161.4 ± 106.1 and 1.8 ± 1.2 pg/mL, respectively. It increased significantly in PDR patients (groups A, B and C) (P = 0.002, <0.001, and <0.001, respectively). PDR patients with preoperative IVC (groups A and B) presented significantly lower VEGF concentrations (P < 0.001 and 0.001), intraoperative bleeding rates (P = 0.004) and total surgical time (P < 0.001, P = 0.003) compared with group C. No statistical differences were presented between groups A and B on the three parameters.
CONCLUSION


Seven days and 14 days of preoperative IVC are equally efficient and safe for the vitrectomy of severe PDR patients through decreasing vitreous VEGF concentrations, intraoperative bleeding rate and total surgical times.",2020,"Seven days and 14 days of preoperative IVC are equally efficient and safe for the vitrectomy of severe PDR patients through decreasing vitreous VEGF concentrations, intraoperative bleeding rate and total surgical times.","['Vitreous specimens of all 80 patients were collected and evaluated afterwards', 'Sixty eyes (60 patients) with severe PDR and 20 eyes from 20 patients with rhegmatogenous retinal detachment complicated with proliferative vitreoretinopathy', 'vitreous humor of patients with severe proliferative diabetic retinopathy after intravitreal injection of', 'PDR eyes', 'Another 20 eyes without diabetes were enrolled as the non-diabetic control group (group D), receiving PPV directly']","['conbercept', 'Vascular endothelial growth factor concentration', 'intravitreal injection of conbercept (IVC']","['mean intravitreal VEGF concentrations', 'total surgical time and the intraoperative bleeding rate', 'total surgical time', 'vitreous VEGF concentrations, intraoperative bleeding rate and total surgical times', 'intraoperative bleeding rates', 'VEGF concentrations', 'intravitreal VEGF concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment (disorder)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0242852', 'cui_str': 'Vitreoretinopathy Neovascular Inflammatory'}, {'cui': 'C0042905', 'cui_str': 'Vitreous Humor'}, {'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441838', 'cui_str': 'Group D (qualifier value)'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",80.0,0.0270129,"Seven days and 14 days of preoperative IVC are equally efficient and safe for the vitrectomy of severe PDR patients through decreasing vitreous VEGF concentrations, intraoperative bleeding rate and total surgical times.","[{'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Meng-Da', 'Initials': 'MD', 'LastName': 'Li', 'Affiliation': 'Ophthalmology Department, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China.'}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Ye', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Zi-Jian', 'Initials': 'ZJ', 'LastName': 'Guo', 'Affiliation': 'Laboratory Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Di', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000687']
927,32129892,Myasthenia gravis patient and physician opinions about immunosuppressant reduction.,"INTRODUCTION


To reduce myasthenia gravis (MG) patient risk of immunosuppressant (IS) exposure adverse events (AEs), such as infections and malignancies, and to reduce treatment burden, international guidelines recommend decreasing IS dose in stable MG patients.
METHODS


Online surveys were conducted of self-identified MG patients and MG physician experts about the importance of IS dose reduction for MG patients who achieve prolonged periods of disease stability.
RESULTS


Eighty-four percent of MG patients (n = 283) and 100% of physicians (n = 45) were concerned about long-term IS-associated AEs. Although both groups favored attempting IS reduction, they raised concerns including MG relapse, hospitalization, and uncertainty about the future. Presented with an estimated 12% significant relapse rate with IS dose reduction, 76% of patients would be willing to enroll in a randomized IS dose reduction trial.
DISCUSSION


Patients and physicians favor considering IS dose reduction but are also concerned about potential negative sequelae.",2020,"Although both groups favored attempting IS reduction, they raised concerns including: MG relapse, hospitalization, and uncertainty about the future.","['Myasthenia Gravis Patient and Physician Opinions', 'Online surveys were conducted of self-identified MG patients and MG physician experts about the importance of IS dose reduction for MG patients who achieve prolonged periods of disease stability']",[],['relapse rate'],"[{'cui': 'C0947912'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0425945', 'cui_str': 'Prolonged periods (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0035020', 'cui_str': 'Relapse'}]",45.0,0.025263,"Although both groups favored attempting IS reduction, they raised concerns including: MG relapse, hospitalization, and uncertainty about the future.","[{'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Hehir', 'Affiliation': 'The Robert Larner M.D. College of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Anna Rostedt', 'Initials': 'AR', 'LastName': 'Punga', 'Affiliation': 'Department of Neuroscience Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ciafaloni', 'Affiliation': 'University of Rochester School of Medicine, Rochester, New York, USA.'}]",Muscle & nerve,['10.1002/mus.26850']
928,32195649,"A pooled analysis of patients with wound infections in the Phase 3 REVIVE trials: randomized, double-blind studies to evaluate the safety and efficacy of iclaprim versus vancomycin for treatment of acute bacterial skin and skin structure infections.","Introduction.  Iclaprim is a diaminopyrimidine antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI) due to Gram-positive pathogens. Aim.  This analysis evaluates patients with wound infections from two Phase 3 trials of ABSSSI. Methodology.  Six-hundred-two patients with wound infections from two Phase 3, double-blinded, randomized, multicenter, active controlled trials (REVIVE-1/-2) were evaluated in a post hoc analysis of iclaprim 80 mg compared with vancomycin 15 mg kg -1  administered intravenously every 12 h for 5-14 days. The primary endpoint was to determine whether iclaprim was non-inferior (10 % margin) to vancomycin in achieving a ≥20 % reduction from baseline in lesion size 48-72 h after starting study drug (early clinical response [ECR]). Safety was assessed. Results.  In REVIVE-1, ECR was 83.5 % with iclaprim versus 79.7 % with vancomycin (treatment difference 3.77%, 95 % CI -4.50%, 12.04%). In REVIVE-2, ECR was 82.7 % with iclaprim versus 76.3 % with vancomycin (treatment difference 6.38%, 95 % CI -3.35%, 16.12%). In the pooled dataset, iclaprim had similar ECR rates compared with vancomycin among wound infection patients (83.2 % vs 78.2 %) with a treatment difference of 5.01 % (95 % CI -1.29%, 11.32%). The safety profile was similar in iclaprim- and vancomycin-treated patients, except for a higher incidence of diarrhea with vancomycin ( n =17) compared with iclaprim ( n =6) and fatigue with iclaprim ( n =17) compared with vancomycin ( n =8). Conclusion.  Based on early clinical response, iclaprim achieved non-inferiority to vancomycin with a similar safety profile in patients with wound infections suspected or confirmed as caused by Gram-positive pathogens. Iclaprim may be a valuable treatment option for wound infections.",2020,"The safety profile was similar in iclaprim- and vancomycin-treated patients, except for a higher incidence of diarrhea with vancomycin ( n =17) compared with iclaprim ( n =6) and fatigue with iclaprim ( n =17) compared with vancomycin ( n =8).","['patients with wound infections from two Phase 3 trials of ABSSSI', 'Six-hundred-two patients with wound infections', 'acute bacterial skin and skin structure infections', 'patients with wound infections', 'patients with wound infections suspected or confirmed as caused by Gram-positive pathogens']","['Iclaprim', 'iclaprim', 'diaminopyrimidine antibiotic', 'iclaprim versus vancomycin', 'vancomycin', 'iclaprim 80\u2009mg compared with vancomycin']","['ECR rates', 'safety and efficacy', 'diarrhea', 'safety profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C4552483', 'cui_str': 'ABSSSI'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}]","[{'cui': 'C1452002', 'cui_str': 'iclaprim'}, {'cui': 'C3653442', 'cui_str': 'Diaminopyrimidines'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",602.0,0.602536,"The safety profile was similar in iclaprim- and vancomycin-treated patients, except for a higher incidence of diarrhea with vancomycin ( n =17) compared with iclaprim ( n =6) and fatigue with iclaprim ( n =17) compared with vancomycin ( n =8).","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Noviello', 'Affiliation': 'Motif BioSciences, Princeton, New Jersey, USA.'}, {'ForeName': 'G Ralph', 'Initials': 'GR', 'LastName': 'Corey', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Holland', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lodise', 'Affiliation': 'Albany College of Pharmacy and Health Sciences, Albany, New York.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': ""O'Riordan"", 'Affiliation': 'eStudySite, San Diego, California, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wilcox', 'Affiliation': 'Leeds Teaching Hospitals & University of Leeds, Leeds, UK.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'File', 'Affiliation': 'Summa Health, Akron, Ohio, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dryden', 'Affiliation': 'Department of Microbiology and Infection, Hampshire Hospitals NHS Foundation Trust, Winchester, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Balser', 'Affiliation': 'Veristat, Southborough, Massachusetts, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Scaramucci', 'Affiliation': 'Veristat, Southborough, Massachusetts, USA.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Torres', 'Affiliation': ""Department of Pulmonology, Hospital Clinic of Barcelona, University of Barcelona, Institut D'investigacions August Pi I Sunyer, Centro de Investigación Biomedica En Red-Enfermedades Respiratorias, Barcelona, Spain.""}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Huang', 'Affiliation': 'Motif BioSciences, Princeton, New Jersey, USA.'}]",Journal of medical microbiology,['10.1099/jmm.0.001177']
929,31922485,Effect of rectal mucosa cleansing on acute prostatitis during prostate biopsy: A randomized prospective study.,"OBJECTIVE


Infectious complications after transrectal ultrasound-guided prostate biopsy (TRUS-PB) can range from asymptomatic bacteriuria and febrile or non-febrile urinary tract infection (UTI) to sepsis. Cleaning of rectal mucosa with topical antiseptics such as povidone iodine or chlorhexidine before the procedure are alternative prophylaxis methods. We aimed to investigate the effects of these two different topical antiseptic agents on infectious complications and their superiority to each other.
MATERIAL AND METHODS


The study was conducted with 200 patients. Rectal mucosa cleansings were performed in 50 patients with povidone iodine and 49 patients with chlorhexidine. The remaining 101 patients did not receive any antiseptic treatment. The results were examined according to the hospital admissions or hospitalization for the first 30 days after the procedure due to UTI, body temperature >38.5°C, sepsis, hematuria, rectal bleeding, and urinary retention.
RESULTS


The mean age of study population was 63.3±7.26 years, and the mean prostate specific antigen value was 13.96±29.5 ng/mL. Acute prostatitis occurred in 14 patients (7%), 9 of whom were hospitalized due to sepsis after TRUS-PB. Statistically significant less acute prostatitis was observed in those patients who were treated with topical rectal antisepsis (topical rectal antisepsis 2% vs. no rectal antisepsis 12.1%, p=0.01). Chlorhexidine and povidone iodine were not superior to each other in terms of inhibiting the development of acute prostatitis (chlorhexidine 2% vs. povidone iodine 2%, p=1.00).
CONCLUSION


Rectal mucosal cleansing with chlorhexidine or povidone iodine before TRUS-PB prevented the development of sepsis due to acute prostatitis. We recommend that this effective method, which is easy to apply, cheap, reliable, easily tolerated should be used in all prostate biopsy practice.",2020,"Chlorhexidine and povidone iodine were not superior to each other in terms of inhibiting the development of acute prostatitis (chlorhexidine 2% vs. povidone iodine 2%, p=1.00).
","['200 patients', '50 patients with', 'acute prostatitis during prostate biopsy']","['Chlorhexidine and povidone iodine', 'topical rectal antisepsis (topical rectal antisepsis', 'rectal mucosa cleansing', 'chlorhexidine', 'transrectal ultrasound-guided prostate biopsy (TRUS-PB', 'topical antiseptic agents', 'povidone iodine or chlorhexidine', 'chlorhexidine or povidone iodine', 'povidone iodine']","['acute prostatitis', 'Acute prostatitis', 'hospital admissions or hospitalization', 'mean prostate specific antigen value', 'sepsis, hematuria, rectal bleeding, and urinary retention']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149524', 'cui_str': 'Acute prostatitis (disorder)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0003424', 'cui_str': 'Antisepsis'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C3540796', 'cui_str': 'Antiseptic throat preparations'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0149524', 'cui_str': 'Acute prostatitis (disorder)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0018965', 'cui_str': 'Hematuria'}, {'cui': 'C0267596', 'cui_str': 'Rectal hemorrhage (disorder)'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}]",101.0,0.028701,"Chlorhexidine and povidone iodine were not superior to each other in terms of inhibiting the development of acute prostatitis (chlorhexidine 2% vs. povidone iodine 2%, p=1.00).
","[{'ForeName': 'Batuhan', 'Initials': 'B', 'LastName': 'Ergani', 'Affiliation': 'Clinic of Urology, Muş State Hospital, Muş, Turkey.'}, {'ForeName': 'Taha', 'Initials': 'T', 'LastName': 'Çetin', 'Affiliation': 'Department of Urology, Health Sciences University Tepecik Training and Research Hospital, İzmir, Turkey.'}, {'ForeName': 'Mehmet Yiğit', 'Initials': 'MY', 'LastName': 'Yalçın', 'Affiliation': 'Department of Urology, Health Sciences University Tepecik Training and Research Hospital, İzmir, Turkey.'}, {'ForeName': 'Mert Hamza', 'Initials': 'MH', 'LastName': 'Özbilen', 'Affiliation': 'Department of Urology, Health Sciences University Tepecik Training and Research Hospital, İzmir, Turkey.'}, {'ForeName': 'Çağdaş', 'Initials': 'Ç', 'LastName': 'Bildirici', 'Affiliation': 'Department of Urology, Health Sciences University Tepecik Training and Research Hospital, İzmir, Turkey.'}, {'ForeName': 'Erkin', 'Initials': 'E', 'LastName': 'Karaca', 'Affiliation': 'Department of Urology, Health Sciences University Tepecik Training and Research Hospital, İzmir, Turkey.'}, {'ForeName': 'Hayal', 'Initials': 'H', 'LastName': 'Boyacıoğlu', 'Affiliation': 'Department of Statistics, Ege University Faculty of Science, İzmir, Turkey.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Koç', 'Affiliation': 'Department of Urology, Health Sciences University Tepecik Training and Research Hospital, İzmir, Turkey.'}, {'ForeName': 'Yusuf Özlem', 'Initials': 'YÖ', 'LastName': 'İlbey', 'Affiliation': 'Department of Urology, Health Sciences University Tepecik Training and Research Hospital, İzmir, Turkey.'}]",Turkish journal of urology,['10.5152/tud.2019.19172']
930,31465859,Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE): Protocol.,"Despite the ubiquity of normal age-related cognitive decline there is an absence of effective approaches for improving neurocognitive health. Fortunately, moderate intensity exercise is a promising method for improving brain and cognitive health in late life, but its effectiveness remains a matter of skepticism and debate because of the absence of large, comprehensive, Phase III clinical trials. Here we describe the protocol for such a randomized clinical trial called IGNITE (Investigating Gains in Neurocognition in an Intervention Trial of Exercise), a study capable of more definitively addressing whether exercise influences cognitive and brain health in cognitively normal older adults. We are conducting a 12-month, multi-site, randomized dose-response exercise trial in 639 cognitively normal adults between 65 and 80 years of age. Participants are randomized to (1) a moderate intensity aerobic exercise condition of 150 min/week (N = 213), (2) a moderate intensity aerobic exercise condition at 225 min/week (N = 213), or (3) a light intensity stretching-and-toning control condition for 150 min/week (N = 213). Participants are engaging in 3 days/week of supervised exercise and two more days per week of unsupervised exercise for 12 months. A comprehensive cognitive battery, blood biomarkers and battery of psychosocial questionnaires is assessed at baseline, 6 and 12-months. In addition, brain magnetic resonance imaging, physiological biomarkers, cardiorespiratory fitness, physical function, and positron emission tomography of amyloid deposition are assessed at baseline and at the 12-month follow-up. The results from this trial could transform scientific-based policy and health care recommendations for approaches to improve cognitive function in cognitively normal older adults.",2019,Despite the ubiquity of normal age-related cognitive decline there is an absence of effective approaches for improving neurocognitive health.,"['cognitively normal older adults', '639 cognitively normal adults between 65 and 80\u202fyears of age']","['moderate intensity aerobic exercise condition of 150\u202fmin/week (N\u202f=\u202f213), (2) a moderate intensity aerobic exercise condition', 'light intensity stretching-and-toning control condition']","['brain magnetic resonance imaging, physiological biomarkers, cardiorespiratory fitness, physical function, and positron emission tomography of amyloid deposition', 'cognitive function', 'comprehensive cognitive battery, blood biomarkers and battery of psychosocial questionnaires']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0011560', 'cui_str': 'Amyloid deposition (morphologic abnormality)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0005768'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.099022,Despite the ubiquity of normal age-related cognitive decline there is an absence of effective approaches for improving neurocognitive health.,"[{'ForeName': 'Kirk I', 'Initials': 'KI', 'LastName': 'Erickson', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.; Discipline of Exercise Science, College of Science, Health, Engineering and Education, Murdoch University, Australia. Electronic address: kiericks@pitt.edu.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Grove', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Burns', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Department of Psychology, Northeastern University, USA; Department of Physical Therapy, Movement, & Rehabilitation Sciences, Northeastern University, USA.'}, {'ForeName': 'Arthur F', 'Initials': 'AF', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychology, Northeastern University, USA; Beckman Institute for Advanced Science and Technology, University of Illinois at Urbana Champaign, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'McAuley', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana Champaign, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Becker', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.; Department of Psychiatry, University of Pittsburgh, USA; Department of Neurology, University of Pittsburgh, USA.'}, {'ForeName': 'Meryl A', 'Initials': 'MA', 'LastName': 'Butters', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, USA.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Gray', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Department of Health and Physical Activity, University of Pittsburgh, USA.'}, {'ForeName': 'M Ilyas', 'Initials': 'MI', 'LastName': 'Kamboh', 'Affiliation': 'Department of Human Genetics, University of Pittsburgh, USA.'}, {'ForeName': 'Chaeryon', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Klunk', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, University of Kansas Medical Center, USA.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Marsland', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mettenburg', 'Affiliation': 'Department of Radiology, University of Pittsburgh, USA.'}, {'ForeName': 'Renee J', 'Initials': 'RJ', 'LastName': 'Rogers', 'Affiliation': 'Department of Health and Physical Activity, University of Pittsburgh, USA.'}, {'ForeName': 'Chelsea M', 'Initials': 'CM', 'LastName': 'Stillman', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.'}, {'ForeName': 'Bradley P', 'Initials': 'BP', 'LastName': 'Sutton', 'Affiliation': 'Beckman Institute for Advanced Science and Technology, University of Illinois at Urbana Champaign, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Szabo-Reed', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Verstynen', 'Affiliation': 'Department of Psychology, Carnegie Mellon University, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Watt', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Weinstein', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, USA.'}, {'ForeName': 'Mariegold E', 'Initials': 'ME', 'LastName': 'Wollam', 'Affiliation': 'Department of Psychology, University of Pittsburgh, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105832']
931,31526218,"A randomized Phase I/II study to evaluate safety and reactogenicity of a heat-stable rotavirus vaccine in healthy adults followed by evaluation of the safety, reactogenicity, and immunogenicity in infants.","Objectives : To assess the safety and reactogenicity of single oral dose of heat-stable rotavirus vaccine (HSRV) in healthy adults aged 18-45 years followed by assessment of safety, reactogenicity, and immunogenicity of three doses of HSRV in healthy infants aged 6-8 weeks at enrollment. Trial Design : Single-center randomized controlled, sequential, blinded (adults) and open-label (infants). Setting : Single site at International Center for Diarrheal Disease Research, Bangladesh (icddr,b). Participants : Fifty eligible adults randomized in 1:1 ratio (HSRV: Placebo) followed by 50 eligible infants randomized in 1:1 ratio (HSRV: Comparator (RotaTeq®, pentavalent human-bovine (WC3) reassortant live-attenuated, rotavirus vaccine)). Intervention : Adults received either a single dose of HSRV or placebo and followed for 14 days. Infants received three doses of either HSRV or comparator with a follow-up for 28 days after each dose. Main Outcome Measures : Solicited and unsolicited adverse events (AEs) along with any serious adverse events (SAEs) were part of the safety and reactogenicity assessment in adults and infants whereas serum anti-rotavirus IgA response rates were part of immunogenicity assessment in infants only. Post-vaccination fecal shedding of vaccine-virus rotavirus strains was also determined in adults and infants. Results : In this study, HSRV, when compared with placebo, did not result in increase in solicited adverse events (solicited AEs) in adults. In infants, HSRV had a safety profile similar to comparator vis-à-vis solicited AEs. In infants, fecal shedding of vaccine-virus strains was not detected in HSRV recipients but was observed in two comparator recipients. Percentage of infants exhibiting threefold rise in serum anti-rotavirus IgA titers from baseline to 1-month post-dose 3 in HSRV group was 88% (22/25) and 84% (21/25) in comparator group. Conclusion : HSRV was found to be generally well-tolerated in both adults and infants and immunogenic in infants.",2020,"In this study, HSRV, when compared with placebo, did not result in increase in solicited adverse events (solicited AEs) in adults.","['adults and infants', 'Adults', 'infants', 'Participants:  Fifty eligible adults randomized in 1:1', 'adults and infants and immunogenic in infants', 'healthy adults aged 18-45 years', 'healthy adults', 'healthy infants aged 6-8 weeks at enrollment']","['ratio (HSRV: Placebo', 'vaccine-virus rotavirus strains', 'HSRV or placebo', 'placebo', 'HSRV', 'ratio (HSRV: Comparator (RotaTeq®, pentavalent human-bovine (WC3) reassortant live-attenuated, rotavirus vaccine', 'heat stable rotavirus vaccine (HSRV', 'heat-stable rotavirus vaccine']","['safety and reactogenicity assessment', 'solicited adverse events', 'Solicited and unsolicited adverse events (AEs) along with any serious adverse events (SAEs', 'safety, reactogenicity and immunogenicity', 'safety and reactogenicity', 'fecal shedding of vaccine-virus strains', 'serum anti-rotavirus IgA titers', 'serum anti-rotavirus IgA response rates', 'safety, reactogenicity, and immunogenicity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C1528013', 'cui_str': 'RotaTeq'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3476459', 'cui_str': 'Rotavirus IgA'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",50.0,0.403958,"In this study, HSRV, when compared with placebo, did not result in increase in solicited adverse events (solicited AEs) in adults.","[{'ForeName': 'Vibhu', 'Initials': 'V', 'LastName': 'Kanchan', 'Affiliation': 'MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.'}, {'ForeName': 'Khalequ', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Asma Binte', 'Initials': 'AB', 'LastName': 'Aziz', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Sheikh Farzana', 'Initials': 'SF', 'LastName': 'Zaman', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Zaman', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Warda', 'Initials': 'W', 'LastName': 'Haque', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Mahbuba', 'Initials': 'M', 'LastName': 'Khanam', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad Mahbubul', 'Initials': 'MM', 'LastName': 'Karim', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Kale', 'Affiliation': 'MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.'}, {'ForeName': 'Syed Khalid', 'Initials': 'SK', 'LastName': 'Ali', 'Affiliation': 'MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Goveia', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Kaplan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Davinder', 'Initials': 'D', 'LastName': 'Gill', 'Affiliation': 'MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.'}, {'ForeName': 'Wasif Ali', 'Initials': 'WA', 'LastName': 'Khan', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Yunus', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Ajitpal', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clemens', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1664239']
932,31526225,"Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trial.","Vaccination against influenza during pregnancy provides direct protection to pregnant women and indirect protection to their infants. Trivalent inactivated influenza vaccines (IIV3s) are safe and effective during pregnancy, but quadrivalent inactivated influenza vaccines (IIV4s) have not been evaluated in pregnant women and their infants. Here, we report the results of a randomized phase IV study to evaluate the immunogenicity and safety of IIV4 vs. IIV3 in pregnant women. Participants aged ≥18 years at weeks 20 to 32 of gestation were randomly assigned in a 2:1 ratio to receive a single dose of IIV4 (n = 230) or IIV3 (n = 116). Between baseline and 21 days after vaccination, hemagglutination inhibition (HAI) antibody titers increased in both groups by similar magnitudes for the two influenza A strains and single B strain common to IIV4 and IIV3. For the additional B strain in IIV4, HAI titers were higher in IIV4 recipients than IIV3 recipients (post-/pre-vaccination geometric mean titer ratio, 6.3 [95% CI: 5.1 - 7.7] vs. 3.4 [95% CI: 2.7 - 4.3]). At delivery, in both groups, HAI antibody titers for all strains were 1.5 - 1.9-fold higher in umbilical cord blood than in maternal blood, confirming active transplacental antibody transfer. Rates of solicited and unsolicited vaccine-related adverse events in mothers were similar between the two groups. Live births were reported for all participants and there were no vaccine-related adverse events in newborns. These results suggest IIV4 is as safe and immunogenic as IIV3 in pregnant women, and that maternal immunization with IIV4 should protect newborns against influenza via passively acquired antibodies.",2020,"Between baseline and 21 days after vaccination, hemagglutination inhibition (HAI) antibody titers increased in both groups by similar magnitudes for the two influenza A strains and single B strain common to IIV4 and IIV3.","['pregnant women and their infants', 'pregnant women and indirect protection to their infants', 'Participants aged ≥18 years at weeks 20 to 32 of gestation', 'pregnant women']","['Trivalent inactivated influenza vaccines (IIV3s', 'quadrivalent inactivated influenza vaccine']","['Rates of solicited and unsolicited vaccine-related adverse events', 'hemagglutination inhibition (HAI) antibody titers', 'HAI antibody titers', 'Immunogenicity and safety', 'HAI titers', 'immunogenicity and safety']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.234689,"Between baseline and 21 days after vaccination, hemagglutination inhibition (HAI) antibody titers increased in both groups by similar magnitudes for the two influenza A strains and single B strain common to IIV4 and IIV3.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Vesikari', 'Affiliation': 'Vaccine Research Center, Tampere University, Tampere, Finland.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Virta', 'Affiliation': 'Tampere Vaccine Research Clinic, Vaccine Research Center, Tampere University, Tampere, Finland.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Heinonen', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Eymin', 'Affiliation': 'Medical Operations, Sanofi Pasteur, Campus Sanofi Lyon, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Lavis', 'Affiliation': 'Medical Operations, Sanofi Pasteur, Campus Sanofi Lyon, Lyon, France.'}, {'ForeName': 'Anne Laure', 'Initials': 'AL', 'LastName': 'Chabanon', 'Affiliation': 'Global Pharmacovigilance, Sanofi Pasteur, Lyon, France.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Gresset-Bourgeois', 'Affiliation': 'Global Pharmacovigilance, Sanofi Pasteur, Lyon, France.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1667202']
933,32162931,Modeling the suicidal behavior cycle: Understanding repeated suicide attempts among individuals with borderline personality disorder and a history of attempting suicide.,"OBJECTIVE


Suicide remains a leading cause of death in the United States, and recent reports have suggested the suicide rate is increasing. One of the most robust predictors of future suicidal behavior is a history of attempting suicide. Despite this, little is known about the factors that reduce the likelihood of reattempting suicide. This study compares theoretically derived suicide risk indicators to determine which factors are most predictive of future suicide attempts.
METHOD


We used data from a randomized, controlled trial comparing 3 forms of dialectical behavior therapy (DBT; Linehan et al., 2015). Participants ( N  = 97, mean age = 30.3 years, 100% female, 71% White) met criteria for borderline personality disorder and had repeated and recent self-injurious behavior. Assessments occurred at 4-month intervals throughout 1 year of treatment and 1 year of follow-up. Time-lagged generalized linear mixed models (GLMMs) were used to evaluate relationship satisfaction, emotion dysregulation, and coping styles as predictors of suicide attempts.
RESULTS


Both univariate and multivariate models suggested that higher between-person variance in problem-focused coping and lack of access to emotion regulation strategies were weakly associated with additional suicide attempts over the 2-year study. Within-person variance in the time-lagged predictors was not associated with subsequent suicide attempts.
CONCLUSIONS


Among individuals with a recent suicide attempt, problem-focused coping and specific deficits in emotion regulation may differentiate those likely to reattempt from those who stop suicidal behavior during and after psychotherapy. These results suggest that treatments for recent suicide attempters should target increasing problem-focused coping and decreasing maladaptive emotion regulation skills. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Both univariate and multivariate models suggested that higher between-person variance in problem-focused coping and lack of access to emotion regulation strategies were weakly associated with additional suicide attempts over the 2-year study.,"['individuals with borderline personality disorder and a history of attempting suicide', 'Participants ( N  = 97, mean age = 30.3 years, 100% female, 71% White) met criteria for borderline personality disorder and had repeated and recent self-injurious behavior']",['dialectical behavior therapy'],"['relationship satisfaction, emotion dysregulation, and coping styles as predictors of suicide attempts']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0455507', 'cui_str': 'H/O: attempted suicide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}]",,0.0736019,Both univariate and multivariate models suggested that higher between-person variance in problem-focused coping and lack of access to emotion regulation strategies were weakly associated with additional suicide attempts over the 2-year study.,"[{'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'Kuehn', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'King', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Marsha M', 'Initials': 'MM', 'LastName': 'Linehan', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Melanie S', 'Initials': 'MS', 'LastName': 'Harned', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000496']
934,32186286,Platform switching versus regular platform single implants: 5-year post-loading results from a randomised controlled trial.,"PURPOSE


To compare the clinical and radiographic outcomes of platform switching (PS) and regular platform (RP) implants.
MATERIALS AND METHODS


This study was designed as a randomised controlled split-mouth trial. Eighteen patients, with bilaterally missing single premolars or molars to be restored with implant-supported single crowns, were consecutively enrolled. Implant sites were randomly assigned to be treated according to the PS concept (PS group), or with matching implant-abutment diameters (RP group). A total of 36 implants were placed in healed bone, with an insertion torque between 35 and 45 Ncm, according to a one-stage protocol. All the implants were loaded with a screw-retained provisional crown 3 months after implant insertion. Definitive screw-retained single crowns were delivered 2 months later. Outcome measures were implant and prosthetic survival rates, biological and prosthetic complications, marginal bone level (MBL) changes, pocket probing depth (PPD) and bleeding on probing (BOP). Clinical data were collected at implant placement (baseline), implant loading (3 months later) and at 9, 36 and 60 months after loading.
RESULTS


One patient dropped out after 4 years of follow-up. No implant failed and no prosthetic complications were recorded during the study period. One patient experienced mucosal inflammation with positive BOP (RP group) after 3 months and three patients had bilateral peri-implant mucosal inflammation with positive BOP at 6, 24 and 36 months, respectively. No other biological complications were recorded up to 60 months of follow-up. There were no statistically significant differences between groups for complications (3/18 versus 4/18; P = 1.0). Nine months after loading the mean MBL was 0.93 ± 0.26 mm (95% CI 0.81 to 1.05) for RP implants and 0.84 ± 0.23 mm (95% CI 0.73 to 0.95) for PS implants. No statistically significant difference was observed between the groups (P = 0.18). Thirty-six months after loading, the mean MBL was 1.09 ± 0.31 mm (95% CI 0.95 to 1.24) in the RP group and 1.06 ± 0.24 mm (95% CI 0.94 to 1.17) in the PS group, with no statistically significant difference between groups (P = 0.70). Sixty months after loading the mean MBL was 1.24 ± 0.39 mm (95% CI 1.05 to 1.43) in the RP group and 1.20 ± 0.21 mm (95% CI 1.01 to 1.39) in the PS group, with no statistically significant difference between the groups (P = 0.85). The mean PPD was 2.58 ± 0.58 mm (95% CI 2.32 to 2.84) in the RP group and 2.40 ± 0.72 mm (95% CI 2.21 to 2.59) in the PS group at 60 months follow-up, with no statistically significant difference between the groups (P = 0.49). The mean BOP was 0.90 ± 0.88 (95% CI 0.58 to 1.22) in the RP group and 0.93 ± 0.97 (95% CI 0.51 to 1.35) in the PS group at 60 months of follow-up, with no statistically significant difference between the groups (P = 0.85).
CONCLUSIONS


Implants restored according to the PS concept and matching implant-abutment diameters showed comparable clinical and radiographic results up to 5 years after loading.",2020,There were no statistically significant differences between groups for complications (3/18 versus 4/18; P = 1.0).,"['Eighteen patients, with bilaterally missing single premolars or molars to be restored with implant-supported single crowns, were consecutively enrolled']","['Definitive screw-retained single crowns', 'platform switching (PS) and regular platform (RP) implants']","['implant and prosthetic survival rates, biological and prosthetic complications, marginal bone level (MBL) changes, pocket probing depth (PPD) and bleeding on probing (BOP', 'mean BOP', 'bilateral peri-implant mucosal inflammation with positive BOP', 'biological complications', 'prosthetic complications', 'complications', 'mean MBL', 'mean PPD', 'mucosal inflammation with positive BOP']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}]","[{'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}]",18.0,0.161943,There were no statistically significant differences between groups for complications (3/18 versus 4/18; P = 1.0).,"[{'ForeName': 'Silvio Mario', 'Initials': 'SM', 'LastName': 'Meloni', 'Affiliation': ''}, {'ForeName': 'Aurea', 'Initials': 'A', 'LastName': 'Lumbau', 'Affiliation': ''}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Baldoni', 'Affiliation': ''}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Pisano', 'Affiliation': ''}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Spano', 'Affiliation': ''}, {'ForeName': 'Olindo', 'Initials': 'O', 'LastName': 'Massarelli', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tallarico', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
935,31604904,Premature Termination of a Randomized Controlled Trial on Image-Guided Stereotactic Body Radiotherapy of Metastatic Spinal Cord Compression.,"LESSONS LEARNED


It is possible to plan and treat some patients with stereotactic body radiotherapy (SBRT) in a timely fashion in an acute setting.Advanced and, in some indications, already implemented technologies such as SBRT are difficult to test in a randomized trial.
BACKGROUND


Stereotactic body radiotherapy (SBRT) in metastatic spinal cord compression (MSCC) could be an alternative to decompressive surgery followed by fractionated radiotherapy.
METHODS


In a randomized, single-institution, noninferiority trial, patients with MSCC were assigned to stereotactic body radiotherapy of 16 Gy in 1 fraction or decompression surgery followed by fractionated radiotherapy of 30 Gy in 10 fractions. Primary endpoint was ability to walk by EQ5D-5L questionnaire. Based on power calculations, 130 patients had to be included to be 89% sure that a 15% difference between the treatment arm and the experimental arm could be detected.
RESULTS


Ten patients were accrued in 23 months, with six patients allocated to surgery and four patients to stereotactic body radiotherapy. The trial was closed prematurely because of poor accrual. One patient undergoing surgery and one patient undergoing stereotactic body radiotherapy were unable to walk at 6 weeks. Two patients were not evaluable at 6 weeks.
CONCLUSION


A randomized, phase II, clinical trial comparing surgery followed by fractionated radiotherapy or image-guided SBRT of MSCC was initiated. SBRT was shown to be feasible, with three out of four patients retaining walking function. The trial was determined futile as a result of low accrual.",2019,"SBRT was shown to be feasible, with three out of four patients retaining walking function.","['metastatic spinal cord compression (MSCC', 'Metastatic Spinal Cord Compression', 'patients with MSCC']","['stereotactic body radiotherapy', 'stereotactic body radiotherapy of 16 Gy in 1 fraction or decompression surgery followed by fractionated radiotherapy', 'stereotactic body radiotherapy (SBRT', 'SBRT', 'Stereotactic body radiotherapy (SBRT', 'Image-Guided Stereotactic Body Radiotherapy', 'fractionated radiotherapy']",['ability to walk by EQ5D-5L questionnaire'],"[{'cui': 'C4076184', 'cui_str': 'Spinal cord compression due to metastasis to spine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",130.0,0.139858,"SBRT was shown to be feasible, with three out of four patients retaining walking function.","[{'ForeName': 'Morten Hiul', 'Initials': 'MH', 'LastName': 'Suppli', 'Affiliation': 'Department of Oncology, Section of Radiotherapy, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Munck Af Rosenschold', 'Affiliation': 'Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Dahl', 'Affiliation': 'Spine Unit, Department of Orthopaedic Surgery, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Kiil', 'Initials': 'AK', 'LastName': 'Berthelsen', 'Affiliation': 'Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Svend Aage', 'Initials': 'SA', 'LastName': 'Engelholm', 'Affiliation': 'Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Pappot', 'Affiliation': 'Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark helle.pappot@regionh.dk.'}]",The oncologist,['10.1634/theoncologist.2019-0672']
936,32187168,"Transactional Sex and Incident Chlamydia and Gonorrhea Among Black Men Who Have Sex With Men in Atlanta, Georgia.","BACKGROUND


Black men who have sex with men (BMSM) are disproportionately affected by sexually transmitted infections (STI), including chlamydia and gonorrhea. Transactional sex is an hypothesized risk factor for STI acquisition in BMSM.
METHODS


We estimated the association of transactional sex with incident chlamydia/gonococcal infection among BMSM using longitudinal data from a randomized trial in Atlanta (2012-2015). BMSM were eligible for inclusion if they tested human immunodeficiency virus (HIV)-antibody-negative and reported both ≥2 male sex partners and any condomless anal sex in the last year. We defined chlamydia/gonorrhea incidence as the first occurrence of either rectal or urogenital chlamydia or gonococcal infections after a negative result at enrollment. We used Poisson regression to estimate the incidence rate (IR) for chlamydia/gonorrhea over 12 months. Incidence rate ratios (IRR) compared estimates by reported experience of transactional sex. Subgroup analyses assessed potential heterogeneity by age and sexual identity.
RESULTS


This analysis included 416 BMSM, of whom 191 (46%) were gay-identified, 146 (42%) reported a history of transactional sex, and 57 (14%) had prevalent chlamydia/gonococcal infection at baseline. Over a median of 1 year of follow-up, an additional 55 men tested laboratory-positive for chlamydia/gonorrhea (IR, 17.3 per 100 person-years). Transactional sex was not associated with chlamydia/gonorrhea incidence overall. However, among gay-identified BMSM, transactional sex was associated with incident chlamydia/gonorrhea (IRR, 2.9; 95% confidence interval, 1.2-6.8).
CONCLUSIONS


Economic and social vulnerabilities may motivate engagement in high-risk sexual behaviors through commodified sex, potentially increasing the burden of STIs among BMSM. In this investigation, the relationship between transactional sex and chlamydia/gonorrhea was not homogenous across BMSM with diverse sexual identities in Atlanta, suggesting that within select sexual networks, transactional sex may drive STI risks. Delivering accessible and targeted STI screening for marginalized BMSM should be prioritized for STI and HIV prevention.",2020,"In this investigation, the relationship between transactional sex and chlamydia/gonorrhea was not homogenous across BMSM with diverse sexual identities in Atlanta, suggesting that within select sexual networks transactional sex may drive STI risks.","['Black men who have sex with men (BMSM', '416 BMSM, of whom 191 (46%) were gay identified, 146 (42%) reported a history of transactional sex, and 57 (14%) had prevalent chlamydia/gonococcal infection at baseline', 'black men who have sex with men in Atlanta, Georgia']",[],"['laboratory-positive for chlamydia/gonorrhea', 'incidence rate (IR) for chlamydia/gonorrhea', 'Transactional sex and incident chlamydia and gonorrhea', 'Incidence rate ratios (IRR']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}]",[],"[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0083017', 'cui_str': 'IRR'}]",,0.0642505,"In this investigation, the relationship between transactional sex and chlamydia/gonorrhea was not homogenous across BMSM with diverse sexual identities in Atlanta, suggesting that within select sexual networks transactional sex may drive STI risks.","[{'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Rucinski', 'Affiliation': 'From the Center for Public Health and Human Rights, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Eaton', 'Affiliation': 'Department of Human Development and Family Sciences, University of Connecticut, Storrs, CT.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Learner', 'Affiliation': 'Oak Ridge Institute for Science and Education, Oak Ridge, TN.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Watson', 'Affiliation': 'Department of Human Development and Family Sciences, University of Connecticut, Storrs, CT.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Maksut', 'Affiliation': 'From the Center for Public Health and Human Rights, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Earnshaw', 'Affiliation': 'Department of Human Development & Family Sciences, University of Delaware, Newark, DE.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001168']
937,32040077,Perspective-taking influences attentional deployment towards facial expressions of pain: an eye-tracking study.,"Empathetic perspective-taking (PT) may be critical in modulating attention and associated responses to another's pain. However, the differential effects of imagining oneself to be in the pain sufferer's situation (""Self-perspective"") or imagining the negative impacts on the pain sufferer's experience (""Other-perspective"") on attention have not been studied. The effects of observer PT (Self vs Other) and level of facial pain expressiveness (FPE) upon attention to another person's pain was investigated. Fifty-two adults were assigned to 1 of 3 PT conditions; they were instructed to view pairs of pain expressions and neutral faces and either (1) consider their own feelings (Self-perspective), (2) consider the feelings of the person in the picture (Other-perspective), or (3) received no further instructions (Control). Eye movements provided indices of early (probability and duration of first fixation) and later (total gaze duration) attentional deployment. Pain faces were more likely to be fixated upon first. A significant first fixation duration bias towards pain was observed, which increased with increasing levels of FPE, and was higher in the Self-PT than the Control condition. The proportion of total gaze duration on pain faces was higher in both experimental conditions than the Control condition. This effect was moderated by FPE in the Self-PT condition; there was a significant increase from low to high FPE. When observers attend to another's facial display of pain, top-down influences (such as PT) and bottom-up influences (such as sufferer's FPE) interact to control deployment and maintenance of attention.",2020,"A significant first fixation duration bias towards pain was observed, which increased with increasing levels of FPE, and was higher in the Self-PT than the Control condition.",['Fifty-two adults'],"['pain expressions and neutral faces and either 1) consider their own feelings (Self-perspective), 2) consider the feelings of the person in the picture (Other-perspective), or 3) received no further instructions (Control', 'Empathetic perspective-taking (PT', 'Perspective-taking influences attentional deployment']","['facial expressions of pain', 'proportion of total gaze duration on pain faces', 'Eye movements provided indices of early (probability and duration of first fixation) and later (total gaze duration) attentional deployment', 'Pain faces', 'fixation duration bias towards pain', 'levels of FPE']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205394', 'cui_str': 'Other (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",52.0,0.0244327,"A significant first fixation duration bias towards pain was observed, which increased with increasing levels of FPE, and was higher in the Self-PT than the Control condition.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Pilch', 'Affiliation': 'Centre for Health Policy and Management, School of Medicine, Trinity College Dublin, Ireland.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'OʼHora', 'Affiliation': 'School of Psychology, College of Arts, Social Sciences, & Celtic Studies National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Jennings', 'Affiliation': 'Center for Pain Research, School of Psychology, College of Arts, Social Sciences, & Celtic Studies National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Caes', 'Affiliation': 'Division of Psychology, Faculty of Natural Sciences, University of Stirling, United Kingdom.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'McGuire', 'Affiliation': 'School of Psychology, College of Arts, Social Sciences, & Celtic Studies National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Kainz', 'Affiliation': 'Department of Psychology, Faculty of Natural Sciences, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Vervoort', 'Affiliation': 'Department of Experimental and Clinical Health Psychology, Faculty of Psychology and Educational Sciences, Ghent University, Ghent, Belgium.'}]",Pain,['10.1097/j.pain.0000000000001827']
938,32185595,"A prospective randomized trial comparing corifollitropin-α late-start (day 4) versus standard administration (day 2) in expected poor, normal, and high responders undergoing controlled ovarian stimulation for IVF.","OBJECTIVE


To assess whether corifollitropin-α (CFα) late-start administration (day 4) and standard administration (day 2) can obtain similar oocyte yield and live birth rate.
STUDY DESIGN


A randomized controlled trial.
SETTING


University Hospital IVF Unit.
PATIENTS


One hundred thirteen women undergoing IVF.
INTERVENTIONS


Patients distributed in three subgroups (expected poor, normal, or high responders to FSH) were randomized into two treatment arms: (a) CFα late-start: CFα on day 4 + GnRH antagonist from day 8 + (when needed) recFSH from day 11; (b) CFα standard start: CFα on day 2 + GnRH antagonist from day 6 + (when needed) recFSH from day 9. IVF or ICSI was performed as indicated.
RESULTS


Considering the whole study group, the late-start regimen obtained comparable oocyte yield (8.9 ± 5.6 vs. 8.8 ± 6.2; p = n.s.), cPR/started cycle (25% vs. 31.6%, p = n.s.), and cumulative live birth rate (LBR)/ovum pickup (OPU) (29.2% vs. 37.7%, p = n.s.) than the standard regimen. The outcome of the two regimens was comparable in the two subgroups of high and normal responders. Differently, in poor responders, oocyte yield was similar, but LBR/OPU was significantly lower with late-start CFα administration that caused 40% cancellation rate due to monofollicular response. ROC curves showed that the threshold AMH levels associated with cycle cancellation were 0.6 ng/ml for late-start regimen and 0.2 ng/ml for standard regimen.
CONCLUSION


CFα may be administered on either day 2 or day 4 to patients with expected high or normal response to FSH without compromising oocyte yield and/or live birth rate. Differently, late-start administration is not advisable for expected poor responders with AMH ≤ 0.6 ng/ml.
TRIAL REGISTRATION


NCT03816670.",2020,The outcome of the two regimens was comparable in the two subgroups of high and normal responders.,"['One hundred thirteen women undergoing IVF', 'University Hospital IVF Unit']","['IVF or ICSI', 'corifollitropin-α late-start (day 4) versus standard administration', 'corifollitropin-α (CFα) late-start administration (day 4) and standard administration', 'CFα late-start: CFα on day 4 + GnRH antagonist from day 8 + (when needed) recFSH']","['oocyte yield', 'LBR/OPU', 'cumulative live birth rate (LBR)/ovum pickup (OPU', 'cPR/started cycle']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C1272689', 'cui_str': 'Started'}]",113.0,0.17166,The outcome of the two regimens was comparable in the two subgroups of high and normal responders.,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Revelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy. alberto.revelli@unito.it.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gennarelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Sestero', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Canosa', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carosso', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Salvagno', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Pittatore', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Filippini', 'Affiliation': 'Clinical Statistics, Department of Surgical Sciences, University of Torino, Corso Bramante 88, Turin, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Benedetto', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-020-01742-5']
939,30702021,Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data From the SM-01 Trial.,"PURPOSE


To report the midterm outcomes of a trial comparing self-expanding nitinol stents to percutaneous transluminal angioplasty (PTA) with provisional stenting in the treatment of obstructive disease in the superficial femoral and popliteal arteries.
MATERIALS AND METHODS


The SM-01 study ( ClinicalTrials.gov identifier NCT01183117), a single-blinded, multicenter, randomized controlled trial in Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis. The groups were well-matched at baseline. Patients were followed to 36 months with duplex imaging. Three-year primary patency was assessed based on a duplex-derived peak systolic velocity ratio <2.5. Freedom from clinically-driven target vessel revascularization (TVR) and target lesions revascularization (TLR) were estimated using the Kaplan-Meier method.
RESULTS


The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group. The S.M.A.R.T stent group had a higher 3-year primary patency rate (73% vs 51%, p=0.033). Freedom from clinically-driven TVR and TLR were not significantly different between the groups.
CONCLUSION


The S.M.A.R.T. stent maintained a higher primary patency rate than PTA at 3 years in this randomized trial; the need for clinically-driven revascularization was similar for both therapies.",2019,"The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group.","['Femoropopliteal Lesions', 'Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis']","['Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty', 'provisional stenting', 'percutaneous transluminal angioplasty (PTA', 'self-expanding nitinol stents']","['vessel revascularization (TVR) and target lesions revascularization (TLR', '3-year primary patency rate', 'technical success rate', 'patency rate', 'frequency of vascular dissection']","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0068790', 'cui_str': 'nickel titanium'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous Transluminal Angioplasty'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}]","[{'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1395545', 'cui_str': 'Vascular dissection'}]",105.0,0.21189,"The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group.","[{'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Iida', 'Affiliation': '1 Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Urasawa', 'Affiliation': '2 Department of Cardiology, Tokeidai Memorial Hospital, Sapporo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Komura', 'Affiliation': '3 Cardiovascular Center, Kaisei Hospital, Sakaide, Japan.'}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Soga', 'Affiliation': '4 Department of Cardiology, Kokura Memorial Hospital, Kitakyushyu, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Inoue', 'Affiliation': '5 Cardiovascular Center, Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Hidehiko', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': '6 Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Yajima', 'Affiliation': '7 Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': '8 Cardiovascular Center, Kyoto Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ohki', 'Affiliation': '9 Department of Surgery, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ando', 'Affiliation': '10 Department of Cardiology, Kasukabe Chuo General Hospital, Kasukabe, Saitama, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hirano', 'Affiliation': '11 Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Horita', 'Affiliation': '12 Department of Cardiology, Kanazawa Cardiovascular Hospital, Kanazawa, Japan.'}, {'ForeName': 'Kimihiko', 'Initials': 'K', 'LastName': 'Kichikawa', 'Affiliation': '13 Department of Radiology, Nara Medical University Hospital, Nara, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Yokoi', 'Affiliation': '14 Department of Cardiology, Kishiwada Tokushukai Hospital, Kishiwada, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Miyamoto', 'Affiliation': '15 Cardiovascular Center, Department of Cardiology, Takatsu General Hospital, Aichi, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': '6 Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Takahara', 'Affiliation': '16 Department of Diabetes Care Medicine and Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Mano', 'Affiliation': '1 Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nanto', 'Affiliation': '17 Department of Cardiology, Nishinomiya Municipal Central Hospital, Nishinomiya, Japan.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602819826591']
940,32178928,"Evaluation of Renal Function at 24, 48, and 72 Hours and 3 Months After Transplant: Comparison of 3 Anesthetic Techniques.","BACKGROUND


General anesthesia is the conventional management of renal transplant, and its evolution has revolved around the development of new drugs; however, a group of patients meet conditions for neuraxial anesthesia, because of their comorbidities, who are at greater risk of complications with general anesthesia and are not favorable to grafting.
METHODS


We conducted a controlled clinical trial of 109 renal transplant recipients where renal function was evaluated at 24, 48, and 72 hours and 3 months after transplant, and we compared regional, general anesthesia with inhaled anesthetic and total intravenous anesthesia. It was performed for 1 year, and serum creatinine, urea nitrogen, and electrolytes were evaluated. During the intraoperative period central venous pressure, mean arterial pressure, vasopressors, fluid therapy, diuretics, surgical time, anesthesia, hot and cold ischemia, immunosuppressants, and antihypertensives were evaluated. They were analyzed with χ 2  independence and 1-way and 2-way repeated measures.
RESULTS


The type of anesthesia was associated with hemodynamic stability (P = .018), the use of vasopressor (P = .005), and fluid therapy (P = .011). A value of P = .005 was found for central venous pressure at discharge from the operating room, and preincisional mean arterial pressure (P = .015) was among the types of anesthesia. Creatinine, blood urea nitrogen, sodium, and potassium were statistically significant over time (P < .001) but showed no difference between types of anesthesia.
CONCLUSION


There is no difference between anesthetic techniques and clinical results over time. The personalized anesthetic technique will improve the neuroendocrine response and surgical stress, decrease the need for vasopressors and analgesics, and reduce complications.",2020,"The type of anesthesia was associated with hemodynamic stability (P = .018), the use of vasopressor (P = .005), and fluid therapy (P = .011).","['109 renal transplant recipients where renal function was evaluated at 24, 48, and 72 hours and 3 months after transplant, and we compared regional, general anesthesia with inhaled anesthetic and total intravenous anesthesia']",[],"['serum creatinine, urea nitrogen, and electrolytes', 'preincisional mean arterial pressure', 'Creatinine, blood urea nitrogen, sodium, and potassium', 'hemodynamic stability', 'central venous pressure', 'intraoperative period central venous pressure, mean arterial pressure, vasopressors, fluid therapy, diuretics, surgical time, anesthesia, hot and cold ischemia, immunosuppressants, and antihypertensives']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}]",[],"[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C1291218', 'cui_str': 'Urea nitrogen (substance)'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C0021891', 'cui_str': 'Intraoperative Period'}, {'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C1563921', 'cui_str': 'Cold Ischemia'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressants'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]",109.0,0.0451861,"The type of anesthesia was associated with hemodynamic stability (P = .018), the use of vasopressor (P = .005), and fluid therapy (P = .011).","[{'ForeName': 'Arnulfo', 'Initials': 'A', 'LastName': 'Calixto-Flores', 'Affiliation': 'Clinical Department of Anesthesiology, High Specialty Medical Unit Specialty Hospital Dr Antonio Fraga Mouret, La Raza National Medical Center, IMSS, Mexico City, Mexico. Electronic address: drrufo@hotmail.com.'}, {'ForeName': 'Monserrat', 'Initials': 'M', 'LastName': 'Román-Sánchez', 'Affiliation': 'Clinical Department of Anesthesiology, High Specialty Medical Unit Specialty Hospital Dr Antonio Fraga Mouret, La Raza National Medical Center, IMSS, Mexico City, Mexico.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Jiménez-Sánchez', 'Affiliation': 'Clinical Department of Anesthesiology, High Specialty Medical Unit Specialty Hospital Dr Antonio Fraga Mouret, La Raza National Medical Center, IMSS, Mexico City, Mexico.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Cruz-Santiago', 'Affiliation': 'Kidney Transplant Unit, High Specialty Medical Unit Specialties Hospital Dr Antonio Fraga Mouret, La Raza National Medical Center, IMSS, Mexico City, Mexico.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Meza-Jiménez', 'Affiliation': 'Kidney Transplant Unit, High Specialty Medical Unit Specialties Hospital Dr Antonio Fraga Mouret, La Raza National Medical Center, IMSS, Mexico City, Mexico.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Bernáldez-Gómez', 'Affiliation': 'Kidney Transplant Unit, High Specialty Medical Unit Specialties Hospital Dr Antonio Fraga Mouret, La Raza National Medical Center, IMSS, Mexico City, Mexico.'}]",Transplantation proceedings,['10.1016/j.transproceed.2020.02.011']
941,32053221,Effect of tongue-strengthening training combined with a tablet personal computer game in healthy adults.,"BACKGROUND


Game-based training has been shown to improve behavioural motor learning in various medical fields including rehabilitation.
OBJECTIVES


This study aimed to investigate the effects of a tablet PC (personal computer) game-based tongue training on tongue strength, thickness and compliance in healthy adults.
METHODS


This study recruited 30 healthy volunteers. Subjects were randomly assigned to two groups (n = 15/group). Group 1 performed game-based tongue training, and group 2 performed tongue resistance training using the Iowa Oral Performance Instrument. Both groups performed the same tongue exercises as follows: frequency (isotonic = 30 times × 3, isometric = 20 seconds × 3), intensity (70% of 1-repeated maximum contraction) and intervention period (5 days for 6 weeks). The primary outcomes were tongue muscle strength and thickness. Secondary outcomes were assessed using a 0-to-10 numerical rating self-report scale that included motivation, interest/fun, physical effort and muscle fatigue/pain.
RESULTS


Both groups showed significant improvement in tongue strength and thickness, but there were no significant differences between the groups after the intervention. The self-report scale numerical rating revealed that group 1 had significantly higher motivation and interest/fun after the exercise than group 2. Group 1 had expended a significantly lower physical effort than group 2. No significant differences were noted between the 2 groups for muscle fatigue/pain.
CONCLUSION


This study showed that both exercises had similar effects on tongue strength and thickness increase in healthy adults, but game-based tongue training was more fun and physically less demanding.",2020,"Both groups showed significant improvement in tongue strength and thickness, but there were no significant differences between the groups after the intervention.","['30 healthy volunteers', 'healthy adults']","['tongue-strengthening\xa0training combined with a tablet personal computer game', 'tablet PC (personal computer) game-based tongue training', 'game-based tongue training, and group 2 performed tongue resistance training using the Iowa Oral Performance Instrument']","['tongue strength and thickness increase', 'tongue strength, thickness, and compliance', 'tongue muscle strength and thickness', 'muscle fatigue/pain', 'tongue strength and thickness', '0-to-10 numerical rating self-report scale that included motivation, interest/fun, physical effort, and muscle fatigue/pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0162419', 'cui_str': 'Personal Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242979', 'cui_str': 'Muscular Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}]",30.0,0.019624,"Both groups showed significant improvement in tongue strength and thickness, but there were no significant differences between the groups after the intervention.","[{'ForeName': 'Na-Kyoung', 'Initials': 'NK', 'LastName': 'Hwang', 'Affiliation': 'Department of Occupational Therapy, Seoul North Municipal Hospital, Seoul, Korea.'}, {'ForeName': 'Min-Ji', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Division of Health Sciences, Department of Dental Hygiene, DongSeo University, Busan, Korea.'}, {'ForeName': 'Gihyoun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Taehyung', 'Initials': 'T', 'LastName': 'Yoon', 'Affiliation': 'Division of Health Sciences, Department of Occupational Therapy, Dongseo University, Seoul, Korea.'}, {'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan, Korea.'}, {'ForeName': 'YoungJin', 'Initials': 'Y', 'LastName': 'Jung', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan, Korea.'}]",Journal of oral rehabilitation,['10.1111/joor.12944']
942,31622159,Potato ingestion is as effective as carbohydrate gels to support prolonged cycling performance.,"Carbohydrate (CHO) ingestion is an established strategy to improve endurance performance. Race fuels should not only sustain performance but also be readily digested and absorbed. Potatoes are a whole-food-based option that fulfills these criteria, yet their impact on performance remains unexamined. We investigated the effects of potato purée ingestion during prolonged cycling on subsequent performance vs. commercial CHO gel or a water-only condition. Twelve cyclists (70.7 ± 7.7 kg, 173 ± 8 cm, 31 ± 9 yr, 22 ± 5.1% body fat; means ± SD) with average peak oxygen consumption (V̇o 2peak ) of 60.7 ± 9.0 mL·kg -1 ·min -1  performed a 2-h cycling challenge (60-85% V̇o 2peak ) followed by a time trial (TT; 6 kJ/kg body mass) while consuming potato, gel, or water in a randomized-crossover design. The race fuels were administered with [U- 13 C 6 ]glucose for an indirect estimate of gastric emptying rate. Blood samples were collected throughout the trials. Blood glucose concentrations were higher ( P  < 0.001) in potato and gel conditions compared with water condition. Blood lactate concentrations were higher ( P  = 0.001) after the TT completion in both CHO conditions compared with water condition. TT performance was improved ( P  = 0.032) in both potato (33.0 ± 4.5 min) and gel (33.0 ± 4.2 min) conditions compared with water condition (39.5 ± 7.9 min). Moreover, no difference was observed in TT performance between CHO conditions ( P  = 1.00). In conclusion, potato and gel ingestion equally sustained blood glucose concentrations and TT performance. Our results support the effective use of potatoes to support race performance for trained cyclists. NEW & NOTEWORTHY  The ingestion of concentrated carbohydrate gels during prolonged exercise has been shown to promote carbohydrate availability and improve exercise performance. Our study aim was to expand and diversify race fueling menus for athletes by providing an evidence-based whole-food alternative to the routine ingestion of gels during training and competition. Our work shows that russet potato ingestion during prolonged cycling is as effective as carbohydrate gels to support exercise performance in trained athletes.",2019,Blood glucose concentrations were higher ( P< 0.001) in potato and gel conditions when compared to water condition.,"['Twelve cyclists (70.7 ± 7.7 kg, 173 ± 8 cm, 31± 9 years, 22 ± 5.1 % body fat; mean ± SD) with average peak oxygen consumption (VO 2PEAK )of 60.7 ± 9.0 mL/kg/min performed a 2 h cycling challenge (60-85%VO 2PEAK ']","['Carbohydrate (CHO) ingestion', 'U', 'commercial CHO gel', 'potato purée ingestion']","['blood glucose concentrations and TT performance', 'TT performance', 'Blood lactate concentrations', 'gastric emptying rate', 'Blood glucose concentrations', 'endurance performance']","[{'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0032846', 'cui_str': 'Potato'}]","[{'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]",,0.0787638,Blood glucose concentrations were higher ( P< 0.001) in potato and gel conditions when compared to water condition.,"[{'ForeName': 'Amadeo F', 'Initials': 'AF', 'LastName': 'Salvador', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Colleen F', 'Initials': 'CF', 'LastName': 'McKenna', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Alamilla', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Ryan M T', 'Initials': 'RMT', 'LastName': 'Cloud', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Keeble', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Miltko', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Susannah E', 'Initials': 'SE', 'LastName': 'Scaroni', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Beals', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Ulanov', 'Affiliation': 'Roy J. Carver Biotechnology Center, Urbana, Illinois.'}, {'ForeName': 'Ryan N', 'Initials': 'RN', 'LastName': 'Dilger', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Bauer', 'Affiliation': 'Department of Animal Sciences, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Broad', 'Affiliation': 'US Olympic and Paralympic Committee, Chula Vista, California.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Burd', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00567.2019']
943,30882730,Impact of Trimethoprim-sulfamethoxazole Urinary Tract Infection Prophylaxis on Non-UTI Infections.,"In this secondary analysis of the Randomized Intervention for Children with Vesicoureteral Reflux cohort, we found that daily prophylaxis with trimethoprim-sulfamethoxazole was not associated with an increased or decreased risk of skin and soft tissue infections, pharyngitis or sinopulmonary infections in otherwise healthy children 2-71 months of age.",2019,"In this secondary analysis of the Randomized Intervention for Children with Vesicoureteral Reflux cohort, we found that daily prophylaxis with trimethoprim-sulfamethoxazole was not associated with an increased or decreased risk of skin and soft tissue infections, pharyngitis or sinopulmonary infections in otherwise healthy children 2-71 months of age.",['Children with Vesicoureteral Reflux cohort'],"['Trimethoprim-sulfamethoxazole', 'trimethoprim-sulfamethoxazole']","['risk of skin and soft tissue infections, pharyngitis or sinopulmonary infections']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042580', 'cui_str': 'Vesicoureteral Reflux'}]","[{'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0149778', 'cui_str': 'Soft Tissue Infection'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",,0.0460613,"In this secondary analysis of the Randomized Intervention for Children with Vesicoureteral Reflux cohort, we found that daily prophylaxis with trimethoprim-sulfamethoxazole was not associated with an increased or decreased risk of skin and soft tissue infections, pharyngitis or sinopulmonary infections in otherwise healthy children 2-71 months of age.","[{'ForeName': 'Sanyukta', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': ""From the Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati OH.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Fisher', 'Affiliation': 'Division of Infectious Diseases in the Departments of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002167']
944,31567817,ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY AND RISK OF TRACTION RETINAL DETACHMENT IN EYES WITH PROLIFERATIVE DIABETIC RETINOPATHY: Pooled Analysis of Five DRCR Retina Network Randomized Clinical Trials.,"PURPOSE


To investigate whether anti-vascular endothelial growth factor (anti-VEGF) for diabetic macular edema or proliferative diabetic retinopathy (PDR) increases the risk of traction retinal detachment (TRD) among eyes with PDR.
METHODS


Pooled analysis of PDR eyes from Protocols I, J, N, S, or T with Early Treatment Diabetic Retinopathy Study level ≥61 (prompt vitrectomy was not planned) randomly assigned to the control group (laser photocoagulation, sham, or intravitreal saline; 396 eyes) or anti-VEGF (487 eyes). The primary outcome was investigator-identified TRD within 1 year of randomization.
RESULTS


The 1-year cumulative probability of TRD was 6.8% (95% confidence interval: 4.6%-9.9%, 25 events) in control-group eyes and 4.8% (95% confidence interval: 3.2%-7.3%, 22 events) in anti-VEGF group eyes (hazard ratio = 0.95 [95% confidence interval: 0.54-1.66, P = 0.86]). The cumulative probability of vitrectomy for TRD was 4.4% (16 events) in control-group eyes and 2.2% (9 events) in anti-VEGF group eyes (P = 0.19). Percentage with TRD and vitrectomy for TRD were similar within strata of diabetic retinopathy severity.
CONCLUSION


These findings do not support the hypothesis that anti-VEGF therapy for diabetic macular edema or PDR increases the risk of TRD among eyes with PDR similar to those enrolled in five DRCR Retina Network protocols for which prompt vitrectomy was not planned.",2020,The cumulative probability of vitrectomy for TRD was 4.4% (16 events) in control-group eyes and 2.2% (9 events) in anti-VEGF group eyes (P = 0.19).,"['DETACHMENT IN EYES WITH PROLIFERATIVE DIABETIC RETINOPATHY', 'diabetic macular edema or proliferative diabetic retinopathy (PDR']","['anti-VEGF therapy', 'TRD and vitrectomy', 'anti-vascular endothelial growth factor (anti-VEGF', 'ANTI-VASCULAR ENDOTHELIAL GROWTH', 'control group (laser photocoagulation, sham, or intravitreal saline; 396 eyes) or anti-VEGF']","['cumulative probability of vitrectomy for TRD', 'investigator-identified TRD within 1 year of randomization', '1-year cumulative probability of TRD']","[{'cui': 'C0541879', 'cui_str': 'Detachment'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",487.0,0.063096,The cumulative probability of vitrectomy for TRD was 4.4% (16 events) in control-group eyes and 2.2% (9 events) in anti-VEGF group eyes (P = 0.19).,"[{'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'B Michele', 'Initials': 'BM', 'LastName': 'Melia', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University Medical School, Chicago, Illinois.'}, {'ForeName': 'Chirag D', 'Initials': 'CD', 'LastName': 'Jhaveri', 'Affiliation': 'Retina Research Center, Austin, Texas.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Salehi-Had', 'Affiliation': 'Atlantis Eye Care, Huntington Beach, California.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Velez', 'Affiliation': 'Valley Eye Physicians and Surgeons, Ayer, Massachusetts.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Harvard Department of Ophthalmology, Joslin Diabetes Center, Beetham Eye Institute, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002633']
945,32180164,"Comparative Responses in Lung Function Measurements with Tiotropium in Adolescents and Adults, and Across Asthma Severities: A Post Hoc Analysis.","INTRODUCTION


Airway obstruction is usually assessed by measuring forced expiratory volume in 1 s (FEV 1 ), forced vital capacity (FVC) and peak expiratory flow (PEF). This post hoc study investigated comparative responses of lung function measurements in adults and adolescents (full analysis set, N = 3873) following treatment with tiotropium Respimat ® .
METHODS


Lung function outcomes were analysed from five phase III trials in adults (≥ 18 years) with symptomatic severe, moderate and mild asthma (PrimoTinA-asthma ® , MezzoTinA-asthma ®  and GraziaTinA-asthma ® , respectively), and one phase III trial in adolescents (12-17 years) with symptomatic moderate asthma (RubaTinA-asthma ® ). Changes from baseline versus placebo in FEV 1 , FVC, PEF and FEV 1 /FVC ratio with tiotropium 5 µg or 2.5 µg added to at least stable inhaled corticosteroids at week 24 (week 12 in GraziaTinA-asthma) were analysed.
RESULTS


All lung function measures improved in all studies with tiotropium 5 µg (mean change from baseline versus placebo), including peak FEV 1  (110-185 mL), peak FVC (57-95 mL) and morning PEF (15.8-25.6 L/min). Changes in adolescents were smaller than those in adults, and were statistically significant primarily for FEV 1  and PEF, but not for FVC.
CONCLUSION


Consistent improvements were seen across all lung function measures with the addition of tiotropium to other asthma treatments in adults across all severities, whereas the improvements with tiotropium in adolescents primarily impacted measures of flow rather than lung volume. This may reflect less pronounced airway remodelling and air trapping in adolescents with asthma versus adults.",2020,"All lung function measures improved in all studies with tiotropium 5 µg (mean change from baseline versus placebo), including peak FEV 1  (110-185 mL), peak FVC (57-95 mL) and morning PEF (15.8-25.6 L/min).","['Lung function outcomes were analysed from five phase III trials in adults (≥\u200918\xa0years) with symptomatic severe, moderate and mild asthma (PrimoTinA-asthma ® , MezzoTinA-asthma ®  and GraziaTinA-asthma ® , respectively), and one phase III trial in adolescents (12-17\xa0years) with symptomatic moderate asthma (RubaTinA-asthma ® ', 'adolescents with asthma versus adults', 'adults and adolescents (full analysis set, N\u2009=\u20093873) following treatment with', 'Adolescents and Adults, and Across Asthma Severities']","['placebo', 'Tiotropium', 'tiotropium Respimat ® ', 'tiotropium']","['peak FVC', 'All lung function measures', 'forced vital capacity (FVC) and peak expiratory flow (PEF']","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0581122', 'cui_str': 'Asthma severity (regime/therapy)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}]",,0.0693147,"All lung function measures improved in all studies with tiotropium 5 µg (mean change from baseline versus placebo), including peak FEV 1  (110-185 mL), peak FVC (57-95 mL) and morning PEF (15.8-25.6 L/min).","[{'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK. d.halpin@nhs.net.'}, {'ForeName': 'Eckard H', 'Initials': 'EH', 'LastName': 'Hamelmann', 'Affiliation': 'Evangelisches Klinikum Bethel, Bielefeld, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Frith', 'Affiliation': 'Respiratory Medicine, Flinders University College of Medicine and Public Health, Adelaide, SA, Australia.'}, {'ForeName': 'Petra M', 'Initials': 'PM', 'LastName': 'Moroni-Zentgraf', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'van Hecke', 'Affiliation': 'Boehringer Ingelheim Pty. Ltd., Sydney, NSW, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Unseld', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonology and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""The Breathing Institute, Children's Hospital Colorado, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA.""}]",Pulmonary therapy,['10.1007/s41030-020-00113-w']
946,32173255,Clinical observations of the effect of orthokeratology in children with myopic anisometropia.,"PURPOSE


To evaluate the clinical effect of orthokeratology in controlling myopia and treating anisometropia among children with myopic anisometropia.
METHODS


A total of 108 myopic anisometropic children aged 8-16 years old who wore orthokeratology lenses in both eyes were enrolled in this study and followed up for over 1 year. The more severely myopic eye of each patient was assigned to the more myopic group (108 eyes), with a mean spherical equivalent refraction of -4.25 (-5.00, -3.38) D; the opposite eye of each patient was assigned to the less myopic group (108 eyes), with a refraction of -2.75 (-3.63, -1.88) D. This study observed and analyzed changes in ocular parameters after orthokeratology (Wilcoxon signed-rank test).
RESULTS


In children who wore orthokeratology lenses for approximately 1 year, the level of anisometropia significantly dropped from 1.38 (1.13, 1.75) D to 1.25 (1.13, 1.75) D (P = .005). The difference between the axial lengths of the two eyes significantly dropped from 0.54 (0.37, 0.74) mm to 0.46 (0.28, 0.67) mm (P< .0001).
CONCLUSIONS


Orthokeratology seemed to be more effective at delaying the progression of myopia in the more myopic eyes than in the less myopic eyes of myopic anisometropic children. Orthokeratology lenses are suitable for anisometropic children, although the effectiveness of orthokeratology against anisometropia requires additional follow-up time for further observation and study.",2020,"In children who wore orthokeratology lenses for approximately 1 year, the level of anisometropia significantly dropped from 1.38 (1.13, 1.75) D to 1.25 (1.13, 1.75) D (P = .005).","['108 myopic anisometropic children aged 8-16 years old who wore orthokeratology lenses in both eyes', 'anisometropic children', 'children with myopic anisometropia']",['Orthokeratology lenses'],"['level of anisometropia', 'axial lengths']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}, {'cui': 'C0003081', 'cui_str': 'Anisometropia'}]","[{'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003081', 'cui_str': 'Anisometropia'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}]",108.0,0.0403991,"In children who wore orthokeratology lenses for approximately 1 year, the level of anisometropia significantly dropped from 1.38 (1.13, 1.75) D to 1.25 (1.13, 1.75) D (P = .005).","[{'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'School of Ophthalmology and Eye Hospital, Wenzhou Medical University, 270 West Xueyuan Road, Wenzhou, Zhejiang, 325027, China.'}, {'ForeName': 'Wanqing', 'Initials': 'W', 'LastName': 'Jin', 'Affiliation': 'School of Ophthalmology and Eye Hospital, Wenzhou Medical University, 270 West Xueyuan Road, Wenzhou, Zhejiang, 325027, China. Electronic address: wcyjqw@163.com.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.03.002']
947,30266892,A Randomized Phase II Trial (TAMIGA) Evaluating the Efficacy and Safety of Continuous Bevacizumab Through Multiple Lines of Treatment for Recurrent Glioblastoma.,"BACKGROUND


We assessed the efficacy and safety of bevacizumab (BEV) through multiple lines in patients with recurrent glioblastoma who had progressed after first-line treatment with radiotherapy, temozolomide, and BEV.
PATIENTS AND METHODS


TAMIGA (NCT01860638) was a phase II, randomized, double-blind, placebo-controlled, multicenter trial in adult patients with glioblastoma. Following surgery, patients with newly diagnosed glioblastoma received first-line treatment consisting of radiotherapy plus temozolomide and BEV, followed by six cycles of temozolomide and BEV, then BEV monotherapy until disease progression (PD1). Randomization occurred at PD1 (second line), and patients received lomustine (CCNU) plus BEV (CCNU + BEV) or CCNU plus placebo (CCNU + placebo) until further disease progression (PD2). At PD2 (third line), patients continued BEV or placebo with chemotherapy (investigator's choice). The primary endpoint was survival from randomization. Secondary endpoints were progression-free survival in the second and third lines (PFS2 and PFS3) and safety.
RESULTS


Of the 296 patients enrolled, 123 were randomized at PD1 (CCNU + BEV,  n  = 61; CCNU + placebo,  n  = 62). The study was terminated prematurely because of the high drop-out rate during first-line treatment, implying underpowered inferential testing. The proportion of patients receiving corticosteroids at randomization was similar (BEV 33%, placebo 31%). For the CCNU + BEV and CCNU + placebo groups, respectively, median survival from randomization was 6.4 versus 5.5 months (stratified hazard ratio [HR], 1.04; 95% confidence interval [CI], 0.69-1.59), median PFS2 was 2.3 versus 1.8 months (stratified HR, 0.70; 95% CI, 0.48-1.00), median PFS3 was 2.0 versus 2.2 months (stratified HR, 0.70; 95% CI, 0.37-1.33), and median time from randomization to a deterioration in health-related quality of life was 1.4 versus 1.3 months (stratified HR, 0.76; 95% CI, 0.52-1.12). The incidence of treatment-related grade 3 to 4 adverse events was 19% (CCNU + BEV) versus 15% (CCNU + placebo).
CONCLUSION


There was no survival benefit and no detriment observed with continuing BEV through multiple lines in patients with recurrent glioblastoma.
IMPLICATIONS FOR PRACTICE


Previous research suggested that there may be value in continuing bevacizumab (BEV) beyond progression through multiple lines of therapy. No survival benefit was observed with the use of BEV through multiple lines in patients with glioblastoma who had progressed after first-line treatment (radiotherapy + temozolomide + BEV). No new safety concerns arose from the use of BEV through multiple lines of therapy.",2019,No survival benefit was observed with the use of BEV through multiple lines in patients with glioblastoma who had progressed after first-line treatment (radiotherapy + temozolomide + BEV).,"['patients with recurrent glioblastoma who had progressed after first-line treatment with radiotherapy, temozolomide, and BEV', 'Recurrent Glioblastoma', '296 patients enrolled, 123 were randomized at PD1 (CCNU + BEV,  n  = 61', 'adult patients with glioblastoma']","['placebo', 'CCNU + placebo', 'Continuous Bevacizumab', 'lomustine (CCNU) plus BEV (CCNU + BEV) or CCNU plus placebo (CCNU + placebo', 'radiotherapy + temozolomide + BEV', 'radiotherapy plus temozolomide and BEV', 'temozolomide and BEV', 'bevacizumab (BEV']","['median survival', 'survival from randomization', 'survival benefit', 'progression-free survival in the second and third lines (PFS2 and PFS3) and safety', 'median PFS2', 'health-related quality of life', 'median PFS3']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0687700', 'cui_str': 'CCNU'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0687700', 'cui_str': 'CCNU'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",296.0,0.606229,No survival benefit was observed with the use of BEV through multiple lines in patients with glioblastoma who had progressed after first-line treatment (radiotherapy + temozolomide + BEV).,"[{'ForeName': 'Alba A', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'Department of Medical Oncology, AUSL, Bologna, Italy alba.brandes@yahoo.it.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gil-Gil', 'Affiliation': ""Institut Catala d'Oncologia, L'Hospitalet, Institut d'Investigació Biomédica de Bellvitge (IDIBELL), Barcelona, Spain.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Saran', 'Affiliation': 'Royal Marsden National Health Service Foundation Trust, Sutton, United Kingdom.'}, {'ForeName': 'Antoine F', 'Initials': 'AF', 'LastName': 'Carpentier', 'Affiliation': 'Paris 7 University, Assistance publique - Hôpitaux de Paris (AP-HP), Paris, France.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Nowak', 'Affiliation': 'School of Medicine, University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Mason', 'Affiliation': 'Cancer Clinical Research Unit, Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Department of Clinical and Experimental Oncology, Medical Oncology Unit 1, Veneto Institute of Oncology-IRCCS, Padua, Italy.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dubois', 'Affiliation': 'Centre Hospitalier Régional et Universitaire de Lille, Lille, France.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Finocchiaro', 'Affiliation': 'Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Fountzilas', 'Affiliation': 'Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Dana Michaela', 'Initials': 'DM', 'LastName': 'Cernea', 'Affiliation': 'The Oncology Institute ""Prof. Dr. Ion Chiricuta,"" Cluj-Napoca, Romania.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Chinot', 'Affiliation': 'Aix-Marseille University, Assistance publique - Hôpitaux de Marseille (AP-HM), CHU Timone, Marseille, France.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Anghel', 'Affiliation': 'Alexandru Trestioreanu Bucharest Institute of Oncology, Bucharest, Romania.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Ghiringhelli', 'Affiliation': 'Centre Georges Francois Leclerc, Dijon, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Beauchesne', 'Affiliation': 'Département de Neuro-Oncologie, Hôpital Central, Nancy, France.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lombardi', 'Affiliation': 'Department of Clinical and Experimental Oncology, Medical Oncology Unit 1, Veneto Institute of Oncology-IRCCS, Padua, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Franceschi', 'Affiliation': 'Department of Medical Oncology, AUSL, Bologna, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Makrutzki', 'Affiliation': 'F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Chiedzo', 'Initials': 'C', 'LastName': 'Mpofu', 'Affiliation': 'F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Hans-Joerg', 'Initials': 'HJ', 'LastName': 'Urban', 'Affiliation': 'F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Pichler', 'Affiliation': 'Institut für Innere Medizin mit Neuroonkologie, Linz, Austria.'}]",The oncologist,['10.1634/theoncologist.2018-0290']
948,32190975,Outcomes of a conservative care program for knee osteoarthritis through translation of research into practice.,"INTRODUCTION


Evidence-based guidelines suggest a conservative, nonsurgical approach as first-line treatment for knee osteoarthritis. However, previous literature has documented underutilization of the fundamental components of condition management emphasized in the guidelines. The intervention aim is to apply organized conservative components of care for knee osteoarthritis in an evidence-based management program through the translation of research into practice with a target to observe meaningful functional improvement in a distinct population.
METHODS


The program, modeled after the nonsurgical arm of a randomized, controlled trial, was designed as a single-arm observational cohort study with a pre- and post-program comparison for participants reporting presence of knee osteoarthritis who were attributed to a specific employer's health plan in the United States. The 12-week intervention consisted of condition education, group exercise, and a dietary intervention.
RESULTS


Ninety-six participants enrolled in the program, of which 72% completed the protocol. The median change in pre- to post-program Knee Injury and Osteoarthritis Outcome Score values was 10.4 ± 0.8 (Z = 210.5, p < 0.001)-a clinically important change. Secondary outcomes were complementary to the primary outcome.
CONCLUSIONS


Results of the program indicate that the clinically significant 3-month findings in the report by Skou et al. (2015) regarding functional improvement can be replicated in an alternate setting. Organizing and offering fundamental components of condition management in a group format with provider oversight could be a feasible and logical component in the continuum of care for knee osteoarthritis, while complementing other secondary management strategies following diagnosis.",2020,"The median change in pre- to post-program Knee Injury and Osteoarthritis Outcome Score values was 10.4 ± 0.8 (Z = 210.5, p < 0.001)-a clinically important change.","['Ninety-six participants enrolled in the program, of which 72% completed the protocol', ""participants reporting presence of knee osteoarthritis who were attributed to a specific employer's health plan in the United States""]","['condition education, group exercise, and a dietary intervention', 'conservative care program']",['median change in pre- to post-program Knee Injury and Osteoarthritis Outcome Score values'],"[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1274022', 'cui_str': 'Employer'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1276393', 'cui_str': 'Group exercise (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",96.0,0.0528215,"The median change in pre- to post-program Knee Injury and Osteoarthritis Outcome Score values was 10.4 ± 0.8 (Z = 210.5, p < 0.001)-a clinically important change.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ross', 'Affiliation': 'Population Health Services, OhioHealth, Columbus, Ohio, USA.'}, {'ForeName': 'Gregg M', 'Initials': 'GM', 'LastName': 'Gascon', 'Affiliation': 'Population Health Services, OhioHealth, Columbus, Ohio, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Snow', 'Affiliation': 'Clinical Transformation, OhioHealth, Columbus, Ohio, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Sawchyn', 'Affiliation': 'Population Health Services, OhioHealth, Columbus, Ohio, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'DeRoads', 'Affiliation': 'McConnell Spine, Sport, and Joint Physicians, OhioHealth, Columbus, Ohio, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Ruane', 'Affiliation': 'McConnell Spine, Sport, and Joint Physicians, OhioHealth, Columbus, Ohio, USA.'}]",Musculoskeletal care,['10.1002/msc.1465']
949,32184185,Efficacy and Safety of 5-HT4 Receptor Agonist Minesapride for Irritable Bowel Syndrome with Constipation in a Randomized Controlled Trial.,"BACKGROUND & AIMS


Treatment options for irritable bowel syndrome with constipation (IBS-C) are limited-new prokinetic drugs are needed. We evaluated the efficacy and safety of minesapride (DSP-6952), a partial agonist with high affinity for 5-HT4 receptors, in patients with IBS-C in Japan.
METHODS


We performed a double-blind phase 2 study of 171 patients with Rome III-defined IBS-C at 33 centers in Japan, from December 2012 through August 2013. Patients were randomly assigned to groups given minesapride (1, 4, 12, or 40 mg) or placebo once daily for 4 weeks. The primary outcome was efficacy, defined as improvement in the weekly frequency of complete spontaneous bowel movements (CSBMs), abdominal symptoms, and IBS-C symptoms (according to the Japanese version of the IBS severity index score). For evaluation of safety, adverse events (AEs) were recorded.
RESULTS


The least squares mean change from baseline in the weekly frequency of CSBMs was greater in all minesapride groups than in the placebo group at week 4 (40 mg vs placebo, P = .040). The abdominal symptoms score improved in minesapride 40 mg group. The overall IBS severity index score decreased from baseline to week 4 in all treatment groups-especially in the 12 mg and 40 mg groups (P = .048 and <.001 vs placebo, respectively). The proportions of patients with treatment-emergent AEs in the pooled minesapride and placebo groups were 55.0% and 60.0%, respectively. The most common treatment-emergent AE was diarrhea (in 42.9% and 37.1% of patients in the pooled minesapride and placebo groups, respectively).
CONCLUSIONS


In a phase 2 trial of patients with IBS-C in Japan, minesapride increased stool frequency (measured by CSBMs), reduced abdominal and overall IBS-C symptoms, and was well tolerated. Japan Pharmaceutical Information Center trial no: JapicCTI-122041.",2020,"The overall IBS severity index score decreased from baseline to week 4 in all treatment groups-especially in the 12 mg and 40 mg groups (P=.048 and <.001 vs placebo, respectively).","['Irritable Bowel Syndrome with Constipation', 'patients with IBS-C in Japan', '171 patients with Rome III-defined IBS-C at 33 centers in Japan, from December 2012 through August 2013', 'irritable bowel syndrome with constipation (IBS-C']","['5-HT4 Receptor Agonist Minesapride', 'minesapride', 'minesapride (DSP-6952', 'placebo']","['frequency of CSBMs', 'Efficacy and Safety', 'overall IBS severity index score', 'tolerated', 'safety, adverse events (AEs', 'abdominal symptoms score', 'weekly frequency of complete spontaneous bowel movements (CSBMs), abdominal symptoms, and IBS-C symptoms (according to the Japanese version of the IBS severity index score', 'diarrhea', 'stool frequency (measured by CSBMs), reduced abdominal and overall IBS-C symptoms']","[{'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0299247', 'cui_str': 'Receptors, Serotonin, 5-HT4'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0740651', 'cui_str': 'Abdominal symptom'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]",171.0,0.416361,"The overall IBS severity index score decreased from baseline to week 4 in all treatment groups-especially in the 12 mg and 40 mg groups (P=.048 and <.001 vs placebo, respectively).","[{'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Fukudo', 'Affiliation': 'Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan. Electronic address: sfukudo@med.tohoku.ac.jp.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Sumitomo Dainippon Pharma Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Tatsuto', 'Initials': 'T', 'LastName': 'Hamatani', 'Affiliation': 'Sumitomo Dainippon Pharma Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Kiyoyasu', 'Initials': 'K', 'LastName': 'Kazumori', 'Affiliation': 'Sumitomo Dainippon Pharma Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Miwa', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.03.019']
950,30882135,Alcohol Screening and Brief Advice in NHS General Dental Practices: A Cluster Randomized Controlled Feasibility Trial.,"AIM


To assess the feasibility and acceptability of screening for alcohol misuse and delivering brief advice to eligible patients attending NHS dental practices in London.
METHODS


A two-arm cluster randomized controlled feasibility trial was conducted. Twelve dental practices were recruited and randomized to intervention and control arms. Participants attending for a dental check were recruited into the study and were eligible if they consumed alcohol above recommended levels assessed by the AUDIT-C screening tool. All eligible participants were asked to complete a baseline socio-demographic questionnaire. Six months after the completion of baseline measures, participants were contacted via telephone by a researcher masked to their allocation status. The full AUDIT tool was then administered. Alcohol consumption in the last 90 days was also assessed using the Form 90. A process evaluation assessed the acceptability of the intervention.
RESULTS


Over a 7-month period, 229 participants were recruited (95.4% recruitment rate) and at the 6 months follow-up, 176 participants were assessed (76.9% retention rate). At the follow-up, participants in the intervention arm were significantly more likely to report a longer abstinence period (3.2 vs. 2.3 weeks respectively, P = 0.04) and non-significant differences in AUDIT (44.9% vs. 59.8% AUDIT positive respectively, P = 0.053) and AUDIT C difference between baseline and follow-up (-0.67 units vs. -0.29 units respectively, P = 0.058). Results from the process evaluation indicated that the intervention and study procedures were acceptable to dentists and patients.
CONCLUSIONS


This study has demonstrated the feasibility and acceptability of dentists screening for alcohol misuse and providing brief advice.",2019,"At the follow-up, participants in the intervention arm were significantly more likely to report a longer abstinence period (3.2 vs. 2.3 weeks respectively, P = 0.04) and non-significant differences in AUDIT (44.9% vs. 59.8% AUDIT positive respectively, P = 0.053) and AUDIT C difference between baseline and follow-up (-0.67 units vs. -0.29 units respectively, P = 0.058).","['Participants attending for a dental check were recruited into the study and were eligible if they consumed alcohol above recommended levels assessed by the AUDIT-C screening tool', 'Twelve dental practices', 'eligible patients attending NHS dental practices in London', 'NHS General Dental Practices']",['Alcohol Screening and Brief Advice'],"['Alcohol consumption', 'likely to report a longer abstinence period']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",229.0,0.309225,"At the follow-up, participants in the intervention arm were significantly more likely to report a longer abstinence period (3.2 vs. 2.3 weeks respectively, P = 0.04) and non-significant differences in AUDIT (44.9% vs. 59.8% AUDIT positive respectively, P = 0.053) and AUDIT C difference between baseline and follow-up (-0.67 units vs. -0.29 units respectively, P = 0.058).","[{'ForeName': 'Antiopi', 'Initials': 'A', 'LastName': 'Ntouva', 'Affiliation': 'Department of Epidemiology and Public Health, UCL, UK.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Porter', 'Affiliation': 'Department of Epidemiology and Public Health, UCL, UK.'}, {'ForeName': 'Mike J', 'Initials': 'MJ', 'LastName': 'Crawford', 'Affiliation': 'Department of Medicine, Imperial College London, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Britton', 'Affiliation': 'Department of Epidemiology and Public Health, UCL, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Gratus', 'Affiliation': 'Department of Epidemiology and Public Health, UCL, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Newton', 'Affiliation': ""King's College London Dental Institute, Kings College London, UK.""}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tsakos', 'Affiliation': 'Department of Epidemiology and Public Health, UCL, UK.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Heilmann', 'Affiliation': 'Department of Epidemiology and Public Health, UCL, UK.'}, {'ForeName': 'Hynek', 'Initials': 'H', 'LastName': 'Pikhart', 'Affiliation': 'Department of Epidemiology and Public Health, UCL, UK.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Watt', 'Affiliation': 'Department of Epidemiology and Public Health, UCL, UK.'}]","Alcohol and alcoholism (Oxford, Oxfordshire)",['10.1093/alcalc/agz017']
951,31493397,Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis.,"BACKGROUND & AIMS


Interleukin 23 contributes to the pathogenesis of ulcerative colitis (UC). We investigated the effects of mirikizumab, a monoclonal antibody against the p19 subunit of interleukin 23, in a phase 2 study of patients with UC.
METHODS


We performed a trial of the efficacy and safety of mirikizumab in patients with moderate to severely active UC, enrolling patients from 14 countries from January 2016 through September 2017. Patients were randomly assigned to groups given intravenous placebo (N = 63), mirikizumab 50 mg (N = 63) or 200 mg (N = 62) with exposure-based dosing, or mirikizumab 600 mg with fixed dosing (N = 61) at weeks 0, 4, and 8. Of assigned patients, 63% had prior exposure to a biologic agent. Clinical responders (decrease in 9-point Mayo score, including ≥2 points and ≥35% from baseline with either a decrease of rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1) at week 12 who had received mirikizumab were randomly assigned to groups that received maintenance treatment with mirikizumab 200 mg subcutaneously every 4 weeks (N = 47) or every 12 weeks (N = 46). The primary endpoint was clinical remission (Mayo subscores of 0 for rectal bleeding, with 1-point decrease from baseline for stool frequency, and 0 or 1 for endoscopy) at week 12. A multiple testing procedure was used that began with the 600-mg dose group, and any nonsignificant comparison result ended the formal statistical testing procedure.
RESULTS


At week 12, 15.9% (P = .066), 22.6% (P = .004), and 11.5% (P = .142) of patients in the 50-mg, 200-mg, and 600-mg groups achieved clinical remission, respectively, compared with 4.8% of patients given placebo. The primary endpoint was not significant (comparison to 600 mg, P > .05). Clinical responses occurred in 41.3% (P = .014), 59.7% (P < .001), and 49.2% (P = .001) of patients in the 50-mg, 200-mg, and 600-mg groups, respectively, compared with 20.6% of patients given placebo. At week 52, 46.8% of patients given subcutaneous mirikizumab 200 mg every 4 weeks and 37.0% given subcutaneous mirikizumab 200 mg every 12 weeks were in clinical remission.
CONCLUSIONS


In a randomized trial of patients with UC, mirikizumab was effective in inducing a clinical response after 12 weeks. Additional studies are required to determine the optimal dose for induction of remission. Mirikizumab showed durable efficacy throughout the maintenance period. Clinicaltrials.gov, Number NCT02589665.",2020,"Clinical responses occurred in 41.3% (P=.014), 59.7% (P<.001), and 49.2% (P=.001) of patients in the 50-mg, 200-mg, and 600-mg groups, respectively, compared to 20.6% of patients given placebo.","['Patients With Ulcerative Colitis', 'patients with UC', 'patients with moderate to severely active UC, enrolling patients from 14 countries from January 2016 through September 2017']","['mirikizumab 50 mg (n=63) or 200 mg (n=62) with exposure-based dosing, or mirikizumab 60 mg with fixed dosing', 'intravenous placebo', 'Mirikizumab', 'mirikizumab', 'placebo', 'subcutaneous mirikizumab']","['rectal bleeding subscore of ≥1 or a rectal bleeding subscore', 'Clinical responses', 'efficacy and safety', 'clinical remission', 'Efficacy and Safety', 'durable efficacy', 'clinical remission (Mayo subscores of 0 for rectal bleeding, with 1-point decrease from baseline for stool frequency, and 0 or 1 for endoscopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0267596', 'cui_str': 'Rectal hemorrhage (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",,0.20817,"Clinical responses occurred in 41.3% (P=.014), 59.7% (P<.001), and 49.2% (P=.001) of patients in the 50-mg, 200-mg, and 600-mg groups, respectively, compared to 20.6% of patients given placebo.","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California San Diego, La Jolla, California. Electronic address: wsandborn@ucsd.edu.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ferrante', 'Affiliation': 'Department of Gastroenterology and Hepatology, Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Bal R', 'Initials': 'BR', 'LastName': 'Bhandari', 'Affiliation': 'Delta Research Partners, Bastrop, Louisiana.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Berliba', 'Affiliation': 'Nicolae Testemitanu State University of Medicine, Arsenia Exploratory Medicine, Chisinau, Moldova.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Western University, Robarts Clinical Trials Inc, London, Ontario, Canada.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hibi', 'Affiliation': 'Kitasato Institute Hospital Center for Advanced Inflammatory Bowel Disease Research and Treatment, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Jay L', 'Initials': 'JL', 'LastName': 'Tuttle', 'Affiliation': 'Eli Lilly and Company, Lilly Biotechnology Center, San Diego, California.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': 'Eli Lilly and Company, Lilly Biotechnology Center, San Diego, California.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Friedrich', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Durante', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'MaryAnn', 'Initials': 'M', 'LastName': 'Morgan-Cox', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Laskowski', 'Affiliation': 'Eli Lilly and Company, Lilly Biotechnology Center, San Diego, California.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schmitz', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}]",Gastroenterology,['10.1053/j.gastro.2019.08.043']
952,30945822,[Zoledronic acid; useful in osteopenia?],"A randomised, double-blind, placebo-controlled trial assessing the effect of zoledronic acid on osteopenia in 2000 women aged 65 years and older over a 6-year treatment period has revealed a statistically significant reduction of fracture incidence. Although the treatment effect seen in this study may have been somewhat overestimated due to selection, the implications for clinical practice could be considerable, as half of all women aged over 65 years are osteopenic and most fractures in the general population occur in this group. However, treatment with zoledronic acid is relatively expensive and the impact on health care costs of treating all older women with osteopenia would be dramatic. Additionally, the decision to treat should be based primarily on fracture risk, which is not only dependent on bone density, but also on other factors such as genetic susceptibility, risk of falling and previous fracture. Zoledronic acid should be reserved for osteopenic women who have an evidently high fracture risk due to these other factors.",2019,"A randomised, double-blind, placebo-controlled trial assessing the effect of zoledronic acid on osteopenia in 2000 women aged 65 years and older over a 6-year treatment period has revealed a statistically significant reduction of fracture incidence.","['older women with osteopenia', 'osteopenic women who have an evidently high fracture risk', 'osteopenia', '2000 women aged 65 years and older over a 6-year treatment period']","['Zoledronic acid', 'placebo', 'zoledronic acid']",['fracture incidence'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",2000.0,0.111071,"A randomised, double-blind, placebo-controlled trial assessing the effect of zoledronic acid on osteopenia in 2000 women aged 65 years and older over a 6-year treatment period has revealed a statistically significant reduction of fracture incidence.","[{'ForeName': 'Diederik L', 'Initials': 'DL', 'LastName': 'Smit', 'Affiliation': 'Amsterdam UMC, locatie VUmc, afd. Interne Geneeskunde.'}, {'ForeName': 'M Carola', 'Initials': 'MC', 'LastName': 'Zillikens', 'Affiliation': 'Erasmus MC, afd. Endocrinologie, Rotterdam.'}, {'ForeName': 'Renate T', 'Initials': 'RT', 'LastName': 'de Jongh', 'Affiliation': 'Amsterdam UMC, locatie VUmc, afd. Interne Geneeskunde.'}]",Nederlands tijdschrift voor geneeskunde,[]
953,31073072,"Results from HARMONY: an open-label, multicenter, 2-arm, phase 1b, dose-finding study assessing the safety and efficacy of the oral combination of ruxolitinib and buparlisib in patients with myelofibrosis.",,2019,,['patients with myelofibrosis'],[],['safety and efficacy'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001815', 'cui_str': 'Idiopathic Myelofibrosis'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.020495,,"[{'ForeName': 'Simon T', 'Initials': 'ST', 'LastName': 'Durrant', 'Affiliation': 'Royal Brisbane Hospital, Herston, Australia simon.durrant@iconcancercare.com.au.'}, {'ForeName': 'Arnon', 'Initials': 'A', 'LastName': 'Nagler', 'Affiliation': 'ALWP Office, Hospital Saint Antoine, Paris, France.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Guglielmelli', 'Affiliation': 'CRIMM-Centro Ricerca e Innovazione delle Malattie Mieloproliferative, Azienda Ospedaliera-Universitaria Careggi, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lavie', 'Affiliation': 'Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'le Coutre', 'Affiliation': 'Charité, Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Gisslinger', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chuah', 'Affiliation': 'Singapore General Hospital, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Maffioli', 'Affiliation': 'Hematology Department, ASST Sette Laghi - Ospedale di Circolo, Varese, Italy.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Bharathy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Tuochuan', 'Initials': 'T', 'LastName': 'Dong', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Wroclawska', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Joaquin Martinez', 'Initials': 'JM', 'LastName': 'Lopez', 'Affiliation': 'Hematology Department, Hospital 12 de Octubre, CNIO, Univ Complutense, CIBERONC, Madrid, Spain.'}]",Haematologica,['10.3324/haematol.2018.209965']
954,32176674,Non-immersive Virtual Reality Rehabilitation Applied to a Task-oriented Approach for Stroke Patients: A Randomized Controlled Trial.,"BACKGROUND


Virtual reality (VR) training allows the creation of the most applicable practice environment incorporated into computer-generated multisensory imagery.
OBJECTIVES


The purpose of this study was to investigate the effects of a virtual training program based on a RAPAEL smart glove on the upper extremity function and quality of life of community-dwelling individuals with chronic hemiparetic stroke.
METHODS


Thirty-six outpatients diagnosed as having a first stroke were selected to receive a therapeutic rehabilitation program at local rehabilitation units. Participants were allocated randomly into two groups: the non-immersive VR training (intervention) group and the recreational activity (control) group. The intervention group received non-immersive VR training using a RAPAEL smart glove for 30 minutes per session, 3 days a week for 8 weeks. The control group performed recreational activities for the same period and also participated in a conventional rehabilitation program for 30 minutes per session, 3 days a week for 8 weeks as an additional therapy. To analyze the effects of the non-immersive VR intervention on upper extremity function, four clinical measures, namely the box and block test (BBT), the Wolf motor function test (WMFT), the Jebsen-Taylor hand function test (JTT), and a grip strength test, were used in this study. For the secondary clinical outcome, the trail-making test (TMT) was used to determine any improvement in cognitive function.
RESULTS


At week 8, upon completion of the non-immersive VR-training the intervention group demonstrated significantly greater WMFT scores (73.0±12.9 to 81.6±7.5), BBT scores (27.3±8.9 to 34.2±7.1), and grip strength (19.2±8.2 to 23.8±8.5) compared with WMFT scores (70.4±12.1 to 73.2±13.1), BBT scores (27.1±10.5 to 28.8±12.9), and grip strength (18.4±4.2 to 18.3±4.9) in the control group.
CONCLUSIONS


This study suggests that virtual upper extremity training using the RAPAEL smart glove has reasonable and beneficial effects on upper extremity and cognitive function for chronic hemiparetic stroke survivors.",2020,"At week 8, upon completion of the non-immersive VR-training the intervention group demonstrated significantly greater WMFT scores (73.0±12.9 to 81.6±7.5), BBT scores (27.3±8.9 to 34.2±7.1), and grip strength (19.2±8.2 to 23.8±8.5) compared with WMFT scores (70.4±12.1 to 73.2±13.1), BBT scores (27.1±10.5 to 28.8±12.9), and grip strength (18.4±4.2 to 18.3±4.9) in the control group.
","['Stroke Patients', 'community-dwelling individuals with chronic hemiparetic stroke', 'chronic hemiparetic stroke survivors', 'Thirty-six outpatients diagnosed as having a first stroke']","['virtual training program', 'non-immersive VR intervention', 'Virtual reality (VR) training', 'non-immersive VR training', 'non-immersive VR training (intervention) group and the recreational activity (control) group', 'therapeutic rehabilitation program at local rehabilitation units']","['cognitive function', 'upper extremity function and quality of life', 'trail-making test (TMT', 'box-block test (BBT), the Wolf motor function test (WMFT), the Jebsen-Taylor hand function test (JTT', 'grip strength', 'recreational activities', 'WMFT scores', 'BBT scores']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",36.0,0.0138026,"At week 8, upon completion of the non-immersive VR-training the intervention group demonstrated significantly greater WMFT scores (73.0±12.9 to 81.6±7.5), BBT scores (27.3±8.9 to 34.2±7.1), and grip strength (19.2±8.2 to 23.8±8.5) compared with WMFT scores (70.4±12.1 to 73.2±13.1), BBT scores (27.1±10.5 to 28.8±12.9), and grip strength (18.4±4.2 to 18.3±4.9) in the control group.
","[{'ForeName': 'Hye-Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': ""Department of Occupational Therapy, Gwang-ju Women's University, Gwangju, Republic of Korea.""}, {'ForeName': 'Jae-Heon', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Department of Physical Therapy, Wonkwang Health Science University, Jeollabuk-do, Republic of Korea.'}, {'ForeName': 'Byeong-Hyeon', 'Initials': 'BH', 'LastName': 'Jeon', 'Affiliation': 'Department of Physical Therapy, Graduate school, Honam University, Gwangju, Republic of Korea.'}, {'ForeName': 'Chiang-Soon', 'Initials': 'CS', 'LastName': 'Song', 'Affiliation': 'Deparment of Occupational Therapy, College of Health Science, Chosun University, Gwangju, Republic of Korea.'}]",Restorative neurology and neuroscience,['10.3233/RNN-190975']
955,32180219,The combination of ibrutinib and rituximab demonstrates activity in first-line follicular lymphoma.,"This phase 2 study evaluated the activity and safety of ibrutinib, a Bruton's tyrosine kinase inhibitor, plus rituximab in adults with previously untreated follicular lymphoma. Patients received once-daily ibrutinib 560 mg continuously plus once-weekly rituximab 375 mg/m 2  for 4 weeks beginning Week 1 (Arm 1, n = 60) or Week 9 (following an 8-week ibrutinib lead-in) to explore biomarkers (Arm 2, n = 20). The primary endpoint was the best overall response rate (ORR). The median age was 58 years; most had an Eastern Cooperative Oncology Group Performance Status of 0 (74%) and Stage III/IV disease (84%). At a median study follow-up of 34 months in Arm 1 and 29 months in Arm 2, ORRs were 85% [95% confidence interval (CI) 73-93] and 75% (95% CI 51-91), respectively, with complete responses in 40% and 50%. The median duration of response was not reached in either arm; 30-month progression-free and overall survival rates were 67% and 97% (Arm 1) and 65% and 100% (Arm 2). The most common adverse events were fatigue, diarrhoea and nausea. Higher grade (Grade 3/4) haematological, haemorrhagic and cardiac events occurred infrequently. Ibrutinib plus rituximab was active and tolerable in first-line follicular lymphoma.",2020,The median duration of response was not reached in either arm; 30-month progression-free and overall survival rates were 67% and 97% (Arm 1) and 65% and 100% (Arm 2).,"['adults with previously untreated follicular lymphoma', 'The median age was 58\xa0years; most had an Eastern Cooperative Oncology Group Performance Status of 0 (74%) and Stage III/IV disease (84', 'first-line follicular lymphoma']","['Ibrutinib plus rituximab', 'ibrutinib and rituximab']","['fatigue, diarrhoea and nausea', 'median duration of response', 'Higher grade (Grade 3/4) haematological, haemorrhagic and cardiac events', 'ORRs', 'overall survival rates', 'overall response rate (ORR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.118287,The median duration of response was not reached in either arm; 30-month progression-free and overall survival rates were 67% and 97% (Arm 1) and 65% and 100% (Arm 2).,"[{'ForeName': 'Nathan H', 'Initials': 'NH', 'LastName': 'Fowler', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Nastoupil', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'De Vos', 'Affiliation': 'David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Knapp', 'Affiliation': 'Zangmeister Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, TN, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Ranjana H', 'Initials': 'RH', 'LastName': 'Advani', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Sumeet', 'Initials': 'S', 'LastName': 'Bhatia', 'Affiliation': 'Community Health Network, Indianapolis, IN, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Mena', 'Affiliation': 'Providence St. Joseph Medical Center, Burbank, CA, USA.'}, {'ForeName': 'Richard Eric', 'Initials': 'RE', 'LastName': 'Davis', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sattva S', 'Initials': 'SS', 'LastName': 'Neelapu', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Eckert', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Ping', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Melannie', 'Initials': 'M', 'LastName': 'Co', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Darrin M', 'Initials': 'DM', 'LastName': 'Beaupre', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Jutta K', 'Initials': 'JK', 'LastName': 'Neuenburg', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'M Lia', 'Initials': 'ML', 'LastName': 'Palomba', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",British journal of haematology,['10.1111/bjh.16424']
956,32023661,"Full-mouth disinfection effects on gingival fluid calprotectin, osteocalcin, and N-telopeptide of Type I collagen in severe periodontitis.","BACKGROUND


To compare the effects of full-mouth disinfection (FMD) and full-mouth ultrasonic debridement (FMUD) on clinical, microbiological and biochemical parameters with conventional quadrant-wise scaling and root planning (Q-SRP) in severe chronic periodontitis.
METHODS


In the present prospective randomized controlled clinical trial with three parallel arms (#NCT04038801), 60 chronic periodontitis patients were randomly assigned to three study groups by a consecutive number in ascending order: FMD (n = 20), FMUD (n = 20), and Q-SRP (n = 20). All measurements and treatments were performed by the same investigator. At baseline, gingival crevicular fluid (GCF) and subgingival plaque were collected and clinical periodontal parameters were recorded. Ultrasonic debridement was completed within 24 hours in FMD and FMUD groups. Chlorhexidine gluconate was used for FMD. Q-SRP was performed by hand instruments per quadrant at 1-week-intervals. Clinical measurements and sampling were repeated at 1, 3, and 6 months after treatment. Real-time PCR was used for quantitative analysis of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia, Fusobacterium nucleatum, and total bacteria count. GCF Calprotectin, osteocalcin, and N-telopeptide of type I collagen (NTx) levels were analyzed by ELISA. The changes of GCF biomarker levels after treatment between groups were the primary outcomes.
RESULTS


No harm was observed. All treatment strategies resulted in significant improvements in all clinical parameters (P < 0.05), with no significant differences between study groups at all time-points (P ˃ 0.05). Aggregatibacter actinomycetemcomitans was significantly decreased in FMD compared to FMUD and Q-SRP at 6 months (P < 0.05). Although GCF NTx total amounts increased in all groups during the study period, this increase was less prominent in full-mouth groups at three time points after treatment (P < 0.05).
CONCLUSIONS


Present results represent the short-term effects. Full-mouth treatment approaches offered limited beneficial effects on microbiological and biochemical parameters over quadrant-wise approach. All three treatment strategies can be recommended in the management of severe chronic periodontitis.",2020,"All treatment strategies resulted in significant improvements in all clinical parameters (p<0.05), with no significant differences between study groups at all time-points (p˃0.05).","['60 chronic periodontitis patients', 'severe chronic periodontitis']","['Chlorhexidine gluconate', 'full-mouth disinfection', 'full-mouth disinfection (FMD) and full-mouth ultrasonic debridement (FMUD', 'Ultrasonic debridement', 'FMUD', 'conventional quadrant-wise scaling and root planning (Q-SRP']","['GCF biomarker levels', 'gingival crevicular fluid (GCF) and subgingival plaque', 'GCF Calprotectin, osteocalcin and N-telopeptide of type', 'I collagen (NTx) levels', 'GCF NTx total amounts', 'Aggregatibacter actinomycetemcomitans', 'gingival crevicular fluid levels of calprotectin, osteocalcin and N-telopeptide of type I collagen']","[{'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0399451', 'cui_str': 'Subgingival plaque (disorder)'}, {'cui': 'C0950624', 'cui_str': 'Calgranulin'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C1868706', 'cui_str': 'N-telopeptide'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0085488', 'cui_str': 'Haemophilus actinomycetemcomitans'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}]",60.0,0.0757924,"All treatment strategies resulted in significant improvements in all clinical parameters (p<0.05), with no significant differences between study groups at all time-points (p˃0.05).","[{'ForeName': 'Beral', 'Initials': 'B', 'LastName': 'Afacan', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Adnan Menderes University, Aydın, Turkey.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Çınarcık', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ege University, İzmir, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Gürkan', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ege University, İzmir, Turkey.'}, {'ForeName': 'Güven', 'Initials': 'G', 'LastName': 'Özdemir', 'Affiliation': 'Department of Biology, Basic and Industrial Microbiology Section, Faculty of Science, Ege University, Izmir, Turkey.'}, {'ForeName': 'Harika Atmaca', 'Initials': 'HA', 'LastName': 'İlhan', 'Affiliation': 'Department of Biology, Section of Molecular Biology, Faculty of Science and Letters, Celal Bayar University, Manisa, Turkey.'}, {'ForeName': 'Caner', 'Initials': 'C', 'LastName': 'Vural', 'Affiliation': 'Department of Biology, Basic and Industrial Microbiology Section, Faculty of Science, Ege University, Izmir, Turkey.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Köse', 'Affiliation': 'Department of Biostatistics and Medical Informatics, Faculty of Medicine, Ege University, Izmir, Turkey.'}, {'ForeName': 'Gülnur', 'Initials': 'G', 'LastName': 'Emingil', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ege University, İzmir, Turkey.'}]",Journal of periodontology,['10.1002/JPER.19-0445']
957,32124728,"Safety and Immunogenicity of Different Formulations of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico: Final Results after 3 Years of Follow-Up from a Randomized, Placebo-Controlled Phase I Study.","Four formulations of an investigational tetravalent dengue purified inactivated vaccine, administered as two doses one month (M) apart, were previously shown to be immunogenic and well-tolerated up to M13 of the phase I study NCT01702857. Here, we report results of the follow-up from M14 to year (Y) 3. One hundred healthy Puerto Rican adults, predominantly dengue virus (DENV)-primed, were randomized 1:1:1:1:1 to receive placebo or vaccine formulations: 1 μg/serotype/dose adjuvanted with aluminum, AS01 E  or AS03 B , or aluminum-adjuvanted 4 μg/serotype/dose. No serious adverse events occurred. Two medically-attended potential immune-mediated disease cases, vaccination unrelated, were reported (groups 1 µg+Alum and 1 µg+AS03 B ). Of 14 instances of suspected dengue, none were laboratory confirmed. Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03 B : 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3). All formulations appeared to be safe and immunogenic during the 3-year follow-up.",2020,"Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03 B : 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3).","['One hundred healthy Puerto Rican adults, predominantly dengue virus (DENV)-primed', 'Healthy Adults from Puerto Rico']","['placebo or vaccine formulations: 1 μg/serotype/dose adjuvanted with aluminum, AS01 E  or AS03 B , or aluminum-adjuvanted 4-μg /serotype/dose', 'Tetravalent Dengue Purified Inactivated Vaccine', 'Placebo']",['Safety and Immunogenicity'],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0034043', 'cui_str': 'Puerto Ricans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011315', 'cui_str': 'Breakbone Fever Virus'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0202311', 'cui_str': 'Aluminum measurement (procedure)'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.0919901,"Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03 B : 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3).","[{'ForeName': 'Clemente', 'Initials': 'C', 'LastName': 'Diaz', 'Affiliation': 'University of Puerto Rico School of Medicine, San Juan, Puerto Rico.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Leyi', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Luis J', 'Initials': 'LJ', 'LastName': 'Martinez', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Campos', 'Affiliation': 'University of Puerto Rico School of Medicine, San Juan, Puerto Rico.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Jarman', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Lepine', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'University of Puerto Rico School of Medicine, San Juan, Puerto Rico.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Vaughn', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Wilson', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Paris', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Schmidt', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0461']
958,32167957,Adding Contralaterally Controlled Electrical Stimulation of the Triceps to Contralaterally Controlled Functional Electrical Stimulation of the Finger Extensors Reduces Upper Limb Impairment and Improves Reachable Workspace but not Dexterity: A Randomized Controlled Trial.,"OBJECTIVE


Different methods of neuromuscular electrical stimulation may be used for poststroke upper limb rehabilitation. This study evaluated the effects of contralaterally controlled functional electrical stimulation of the triceps and finger extensors.
DESIGN


This is a randomized controlled trial of 67 participants who were less than 2 yrs poststroke and assigned to the following: (a) arm + hand contralaterally controlled functional electrical stimulation, (b) hand contralaterally controlled functional electrical stimulation, or (c) arm + hand cyclic neuromuscular electrical stimulation. Participants were prescribed 10 sessions/week of assigned electrical stimulation at home plus 24 sessions of functional task practice in the laboratory for 12 wks. The primary outcome measure was the Box and Blocks Test. Secondary measures included reachable workspace, Upper Extremity Fugl-Meyer, Stroke Upper Limb Capacity Scale, Arm Motor Abilities Test, and Motor Activity Log.
RESULTS


There were no significant between-group differences on the Box and Blocks Test. At 6 mos after treatment, arm + hand contralaterally controlled functional electrical stimulation improved reachable workspace more than hand contralaterally controlled functional electrical stimulation, between-group difference of 264 (95% confidence interval = 28-500) cm and more than arm + hand cyclic neuromuscular electrical stimulation, between-group difference of 281 (95% confidence interval = 22-540) cm. Arm + hand contralaterally controlled functional electrical stimulation improved Upper Extremity Fugl-Meyer score more than hand contralaterally controlled functional electrical stimulation, between-group difference of 6.7 (95% confidence interval = 0.6-12.7). The between-group differences on the Stroke Upper Limb Capacity Scale and Arm Motor Abilities Test were not significant.
CONCLUSIONS


Adding contralaterally controlled elbow extension to hand contralaterally controlled functional electrical stimulation does not improve on gains in hand dexterity, but it further reduces upper limb impairment and improves reachable workspace measured in the laboratory. However, these additional benefits may not be large enough to be perceived by stroke survivors when they are performing activities of daily living at home.",2020,"CCFES improved UEFM score more than Hand CCFES, between-group difference of 6.7 (95% CI, 0.6-12.7).",['67 participants <2 years post-stroke assigned to'],"['neuromuscular electrical stimulation (NMES', 'contralaterally controlled functional electrical stimulation (CCFES']","['theSULCS and AMAT', 'Box and Blocks Test (BBT', 'reachable workspace', 'UEFM score', 'Reachable Workspace (RW), Upper Extremity Fugl-Meyer (UEFM), Stroke Upper Limb Capacity Scale (SULCS), and Arm Motor Abilities Test (AMAT), and Motor Activity Log (MAL', 'BBT']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]","[{'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}]",67.0,0.175681,"CCFES improved UEFM score more than Hand CCFES, between-group difference of 6.7 (95% CI, 0.6-12.7).","[{'ForeName': 'Jayme S', 'Initials': 'JS', 'LastName': 'Knutson', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, MetroHealth Rehabilitation Institute (JSK, NSM, MYH, TZH, RDW, JC), and the Center for Healthcare Research and Policy (DDG), The MetroHealth System, Cleveland, Ohio; Cleveland Functional Electrical Stimulation Center, Cleveland, Ohio (JSK, NSM, MYH, TZH, RDW, JC); and Departments of Physical Medicine and Rehabilitation (JSK, NSM, RDW, JC), Medicine (DDG), and Biomedical Engineering (JC), Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Nathaniel S', 'Initials': 'NS', 'LastName': 'Makowski', 'Affiliation': ''}, {'ForeName': 'Mary Y', 'Initials': 'MY', 'LastName': 'Harley', 'Affiliation': ''}, {'ForeName': 'Terri Z', 'Initials': 'TZ', 'LastName': 'Hisel', 'Affiliation': ''}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Gunzler', 'Affiliation': ''}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chae', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001363']
959,32167864,Prognostic Value of Tumor Deposits for Disease-Free Survival in Patients With Stage III Colon Cancer: A Post Hoc Analysis of the IDEA France Phase III Trial (PRODIGE-GERCOR).,"PATIENTS AND METHODS


A post hoc analysis of all pathologic reports from patients with stage III CC included in the IDEA France phase III study (ClinicalTrials.gov identifier: NCT00958737) investigating the duration of adjuvant fluorouracil, leucovorin, and oxaliplatin or capecitabine and oxaliplatin therapy (3  v  6 months) was performed. The primary objective was to determine the prognostic impact of TD on disease-free survival (DFS). The effect of the addition of TD to LNM count on pN restaging was also evaluated. A multivariable analysis was performed to establish the association between TD and DFS.
RESULTS


Of 1,942 patients, 184 (9.5%) had TDs. The pN1a/b and pN1c populations showed similar DFS. TD-positive patients had worse prognosis compared with TD-negative patients, with 3-year DFS rates of 65.6% (95% CI, 58.0% to 72.1%) and 74.7% (95% CI, 72.6% to 76.7%;  P  = .0079), respectively. On multivariable analysis, TDs were associated with a higher risk of recurrence or death (hazard ratio [HR], 1.36;  P  = .0201). Other adverse factors included pT4 and/or pN2 disease (HR, 2.21;  P  < .001), the 3 months of adjuvant treatment (HR, 1.29;  P  = .0029), tumor obstruction (HR, 1.28;  P  = .0233), and male sex (HR, 1.24;  P  = .0151). Patients restaged as having pN2 disease (n = 35, 2.3%) had similar DFS as patients initially classified as pN2.
CONCLUSION


The presence of TDs is an independent prognostic factor for DFS in patients with stage III CC. The addition of TD to LNM may help to better define the duration of adjuvant therapy.",2020,"Other adverse factors included pT4 and/or pN2 disease (HR, 2.21;  P  < .001), the 3 months of adjuvant treatment (HR, 1.29;  P  = .0029), tumor obstruction (HR, 1.28;  P  = .0233), and male sex (HR, 1.24;  P  = .0151).","['patients with stage III CC', 'Of 1,942 patients, 184 (9.5%) had TDs', 'A post hoc analysis of all pathologic reports from patients with stage III CC included in the IDEA France phase III study (ClinicalTrials.gov identifier', 'Patients With Stage III Colon Cancer']","['fluorouracil, leucovorin, and oxaliplatin or capecitabine and oxaliplatin therapy']","['3-year DFS rates', 'higher risk of recurrence or death', 'tumor obstruction', 'prognostic impact of TD on disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4087140', 'cui_str': 'Tumour obstruction'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",,0.122603,"Other adverse factors included pT4 and/or pN2 disease (HR, 2.21;  P  < .001), the 3 months of adjuvant treatment (HR, 1.29;  P  = .0029), tumor obstruction (HR, 1.28;  P  = .0233), and male sex (HR, 1.24;  P  = .0151).","[{'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Delattre', 'Affiliation': 'Department of Medical Oncology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Paris, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': 'Department of Medical Oncology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Henriques', 'Affiliation': 'Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Falcoz', 'Affiliation': 'Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Emile', 'Affiliation': 'Department of Pathology, AP-HP, Hôpital Ambroise Paré, Boulogne, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Fratte', 'Affiliation': 'Department of Medical Oncology, Hôpital de Belfort-Montbeliard, Montbeliard, France.'}, {'ForeName': 'Benoist', 'Initials': 'B', 'LastName': 'Chibaudel', 'Affiliation': 'Department of Medical Oncology, Institut Franco-Britannique, Levallois-Perret, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Dauba', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier Layné, Mont-de-Marsan, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dupuis', 'Affiliation': 'Clinique Victor Hugo, Le Mans, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Bécouarn', 'Affiliation': 'Department of Medical Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Bibeau', 'Affiliation': 'Department of Pathology, Centre Hospitalier Universitaire de Caen, Université Caen Normandie, Caen, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Department of Medical Oncology, Sorbonne Paris Cité, Université Paris Descartes, AP-HP, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Louvet', 'Affiliation': 'Department of Medical Oncology, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Paris, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Svrcek', 'Affiliation': 'Sorbonne Université, Paris, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01960']
960,30863974,"HPV Vaccination and Korean American College Women: Cultural Factors, Knowledge, and Attitudes in Cervical Cancer Prevention.","Human papillomavirus (HPV) is the most prevalent sexually transmitted infection that leads to nearly all cervical cancers in the United States (U.S.), which could be prevented with the HPV vaccine. Korean American women experience a high burden of cervical cancer, but little is known about their awareness, knowledge, attitudes, sociocultural factors and social network/support related to intention to obtain the HPV vaccine. This study reports baseline characteristics of 104 Korean American college women aged 18-26 and who have not been previously vaccinated against HPV, as part of a pilot randomized controlled trial testing feasibility, acceptability, and preliminary effectiveness of an HPV storytelling intervention. Data were analyzed including descriptive statistics, bivariate analysis, and multivariate logistic regression. Multivariate logistic regression was performed to understand the relationship between independent predictors of intention to receive HPV vaccination. Overall, 34.6% of participants intended to obtain the vaccine. Positive predictors of intention to receive HPV vaccine were: years in the U.S., academic major, awareness of HPV and HPV vaccine, knowledge, and HPV recommendation by healthcare provider and parents. The multivariate logistic model showed that intention to receive the HPV vaccine was significantly associated with HPV vaccine recommendation by parents (OR 4.58, 95% CI 1.37-15.36) and knowledge (OR 1.11, 95% CI 1.11-1.22). These findings suggest a need for development of interventions that are not only culturally tailored but also acculturation-sensitive to promote HPV vaccination among Korean American college women. This may play a significant role in cervical cancer prevention among Korean American college women.",2019,These findings suggest a need for development of interventions that are not only culturally tailored but also acculturation-sensitive to promote HPV vaccination among Korean American college women.,"['Korean American women experience a high burden of cervical cancer', 'Korean American college women', 'Korean American College Women', '104 Korean American college women aged 18-26 and who have not been previously vaccinated against HPV']","['HPV vaccine', 'HPV Vaccination', 'HPV storytelling intervention']",['cervical cancer prevention'],"[{'cui': 'C0597921', 'cui_str': 'Korean Americans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",104.0,0.140808,These findings suggest a need for development of interventions that are not only culturally tailored but also acculturation-sensitive to promote HPV vaccination among Korean American college women.,"[{'ForeName': 'Minjin', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, 368 Plantation Street, Worcester, MA, 01605, USA. Minjin.kim2@umassmed.edu.'}, {'ForeName': 'Haeok', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College of Nursing and Health Sciences, University of Massachusetts Boston, 100 Morrissey Boulevard, Boston, MA, 02125-3393, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kiang', 'Affiliation': 'School for Global Inclusion and Social Development, University of Massachusetts Boston, 100 Morrissey Boulevard, Boston, MA, 02125-3393, USA.'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Aronowitz', 'Affiliation': 'College of Nursing and Health Sciences, University of Massachusetts Boston, 100 Morrissey Boulevard, Boston, MA, 02125-3393, USA.'}, {'ForeName': 'Lisa Kennedy', 'Initials': 'LK', 'LastName': 'Sheldon', 'Affiliation': 'Oncology Nursing Society, 125 Enterprise Drive, Pittsburgh, PA, 15275, USA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'College of Nursing and Health Sciences, University of Massachusetts Boston, 100 Morrissey Boulevard, Boston, MA, 02125-3393, USA.'}, {'ForeName': 'Sun', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'College of Nursing and Health Sciences, University of Massachusetts Boston, 100 Morrissey Boulevard, Boston, MA, 02125-3393, USA.'}, {'ForeName': 'Jeroan', 'Initials': 'J', 'LastName': 'Allison', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, 368 Plantation Street, Worcester, MA, 01605, USA.'}]",Journal of community health,['10.1007/s10900-019-00634-9']
961,32164877,"Adjuvant  131 I-metuximab for hepatocellular carcinoma after liver resection: a randomised, controlled, multicentre, open-label, phase 2 trial.","BACKGROUND


Effective adjuvant treatment after hepatectomy for hepatocellular carcinoma (HCC) is an important area of research. Radioactive iodine ( 131 I)-labelled metuximab is a radiolabelled monoclonal antibody against the CD147 (also known as basigin or HAb18G) antigen that is expressed in HCC. We aimed to examine the role of  131 I-metuximab as an adjuvant therapy after HCC resection.
METHODS


This randomised, controlled, multicentre, open-label, phase 2 trial was done at five medical centres in China. Patients aged 18-75 years who underwent curative-intent resection of histologically confirmed HCC expressing CD147 were randomly assigned (1:1) by a computer-generated random sequence, stratified by centre, to receive either adjuvant transarterial injection of one dose of 27·75 MBq/kg  131 I-metuximab 4-6 weeks after the hepatectomy (treatment group) or no adjuvant treatment (control group). Patients and physicians were not masked to the study groups. The primary outcome was 5-year recurrence-free survival (RFS) in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT00819650.
FINDINGS


Between April 1, 2009, and Nov 30, 2012, 485 patients were screened for eligibility. 329 (68%) of these patients were excluded and 156 (32%) were randomly assigned to receive either  131 I-metuximab (n=78) or no adjuvant treatment (n=78). The median follow-up was 55·9 months (IQR 18·6-79·4). In the intention-to-treat population, the 5-year RFS was 43·4% (95% CI 33·6-55·9) in the  131 I-metuximab group and 21·7% (14·2-33·1) in the control group (hazard ratio 0·49 [95% CI 0·34-0·72]; Z=2·96, p=0·0031).  131 I-metuximab-associated adverse events occurred within the first 4 weeks in 34 (45%) of 76 patients, seven (21%) of whom had grade 3 or 4 adverse events. These adverse events were all resolved with appropriate treatment within 2 weeks of being identified.
INTERPRETATION


Adjuvant  131 I-metuximab treatment significantly improved the 5-year RFS of patients after hepatectomy for HCC tumours expressing CD147. This treatment was well tolerated by patients.
FUNDING


State Key Project on Infectious Diseases of China.",2020,"INTERPRETATION


Adjuvant  131 I-metuximab treatment significantly improved the 5-year RFS of patients after hepatectomy for HCC tumours expressing CD147.","['five medical centres in China', 'Patients aged 18-75 years who underwent curative-intent resection of histologically confirmed HCC expressing CD147', 'hepatocellular carcinoma (HCC', 'hepatocellular carcinoma after liver resection', 'Between April 1, 2009, and Nov 30, 2012, 485 patients were screened for eligibility', '329 (68%) of these patients were excluded and 156 (32%) were randomly assigned to receive either  131']","['adjuvant transarterial injection of one dose of 27·75 MBq/kg  131', 'I-metuximab (n=78) or no adjuvant treatment', 'hepatectomy (treatment group) or no adjuvant treatment (control group', 'Radioactive iodine']","['5-year recurrence-free survival (RFS', 'adverse events', '5-year RFS']","[{'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0522522', 'cui_str': 'Transarterial approach (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0556640', 'cui_str': 'MBq'}, {'cui': 'C1722700', 'cui_str': 'metuximab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",485.0,0.168194,"INTERPRETATION


Adjuvant  131 I-metuximab treatment significantly improved the 5-year RFS of patients after hepatectomy for HCC tumours expressing CD147.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jingliang', 'Initials': 'J', 'LastName': 'Xing', 'Affiliation': ""Cell Engineering Research Center, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yefa', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Interventional Radiology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jingfeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Hepatobiliary Surgery, First Affiliated and Mengchao Hepatobiliary Surgery Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatopancreatobiliary Surgery, West China Hospital, West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhenlin', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Kui', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Interventional Radiology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xuying', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Department of Clinical Database, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Chunfang', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Clinical Laboratory, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Anfeng', 'Initials': 'A', 'LastName': 'Si', 'Affiliation': 'Department of Clinical Database, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Hongyang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Centre for Liver Cancer, Key Laboratory of Signaling Regulation and Targeting Therapy of Liver Cancer of the Ministry of Education of China, Shanghai Key Laboratory of Hepatobiliary Tumor Biology, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Mengchao', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China; Department of Interventional Radiology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Wan Yee', 'Initials': 'WY', 'LastName': 'Lau', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China; Faculty of Medicine, Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Area, China.'}, {'ForeName': 'Zhinan', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Cell Engineering Research Center, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China. Electronic address: shenfengehbh@sina.com.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30422-4']
962,32172295,Accommodative response in children with attention deficit hyperactivity disorder (ADHD): the influence of accommodation stimulus and medication.,"BACKGROUND


There are claims that ocular accommodation differs in children with attention deficit hyperactivity disorder (ADHD) compared to typically developing children. We examined whether the accommodation response in ADHD children is influenced by changing the stimulus to accommodation in an attempt modify the level of attentional engagement or by medication for the condition.
METHODS


We measured the accommodative response and pupil diameter using a binocular, open-field autorefractor in non-medicated and medicated children with ADHD (n = 22, mean age = 10.1 ± 2.4 years; n = 19; mean age = 11.0 ± 3.8 years; respectively) and in an age-matched control group (n = 22; mean age = 10.6 ± 1.9 years) while participants were asked to maintain focus on (i) a high-contrast Maltese cross, (ii) a frame of a cartoon movie (picture) and (iii) a cartoon movie chosen by the participant. Each stimulus was viewed for 180 s from a distance of 25 cm, and the order of presentation was randomised.
RESULTS


Greater lags of accommodation were present in the non-medicated ADHD in comparison to controls (p = 0.023, lags of 1.10 ± 0.56 D and 0.72 ± 0.57 D, respectively). No statistically significant difference in the mean accommodative lag was observed between medicated ADHD children (lag of 1.00 ± 0.44D) and controls (p = 0.104) or between medicated and non-medicated children with ADHD (p = 0.504). The visual stimulus did not influence the lag of accommodation (p = 0.491), and there were no significant group-by-stimulus interactions (p = 0.935). The variability of accommodation differed depending on the visual stimulus, with higher variability for the picture condition compared to the cartoon-movie (p < 0.001) and the Maltese cross (p = 0.006). In addition, the variability yielded statistically significant difference for the main effect of time-on-task (p = 0.027), exhibiting a higher variability over time. However, no group differences in accommodation variability were observed (p = 0.935).
CONCLUSIONS


Children with ADHD have a reduced accommodative response, which is not influenced by the stimulus to accommodation. There is no marked effect of medication for ADHD on accommodation accuracy.",2020,"Greater lags of accommodation were present in the non-medicated ADHD in comparison to controls (p = 0.023, lags of 1.10 ± 0.56 D and 0.72 ± 0.57 D, respectively).","['children with attention deficit hyperactivity disorder (ADHD', 'non-medicated and medicated children with ADHD (n\u2009=\u200922, mean age\u2009=\u200910.1\u2009±\u20092.4\xa0years; n\u2009=\u200919; mean age\u2009=\u200911.0\u2009±\u20093.8\xa0years; respectively) and in an age-matched control group (n\u2009=\u200922; mean age\u2009=\u200910.6\u2009±\u20091.9\xa0years) while participants were asked to maintain focus on (i) a high-contrast Maltese cross, (ii) a frame of a', 'Children with ADHD', 'ADHD children']",['cartoon movie (picture) and (iii) a cartoon movie chosen by the participant'],"['lag of accommodation', 'Accommodative response', 'accommodative response', 'Greater lags of accommodation', 'accommodation variability', 'accommodative response and pupil diameter', 'mean accommodative lag']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}]","[{'cui': 'C0007306', 'cui_str': 'Cartoons'}, {'cui': 'C0681495', 'cui_str': 'Movies'}]","[{'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C1827224', 'cui_str': 'Accommodative response (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.024603,"Greater lags of accommodation were present in the non-medicated ADHD in comparison to controls (p = 0.023, lags of 1.10 ± 0.56 D and 0.72 ± 0.57 D, respectively).","[{'ForeName': 'Beatríz', 'Initials': 'B', 'LastName': 'Redondo', 'Affiliation': 'Department of Optics, Faculty of Science, University of Granada, Campus de la Fuentenueva 2, 18001, Granada, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Molina', 'Affiliation': 'Department of Optics, Faculty of Science, University of Granada, Campus de la Fuentenueva 2, 18001, Granada, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vera', 'Affiliation': 'Department of Optics, Faculty of Science, University of Granada, Campus de la Fuentenueva 2, 18001, Granada, Spain. veraj@ugr.es.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Muñoz-Hoyos', 'Affiliation': 'Paediatrics Service, Faculty of Medicine, University of Granada, Granada, Spain.'}, {'ForeName': 'Brendan T', 'Initials': 'BT', 'LastName': 'Barrett', 'Affiliation': 'School of Optometry and Vision Sciences, Faculty of Life Sciences, University of Bradford, Bradford, UK.'}, {'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'Jiménez', 'Affiliation': 'Department of Optics, Faculty of Science, University of Granada, Campus de la Fuentenueva 2, 18001, Granada, Spain.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04645-4']
963,32173464,"Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Second-Line Treatment of Patients With NSCLC: Results From an Expansion Cohort of a Phase 1 Trial.","INTRODUCTION


The safety and efficacy of bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of the transforming growth factor β (TGF-β) receptor II (a TGF-β ""trap"") fused to a human immunoglobulin G1 antibody blocking programmed death-ligand 1 (PD-L1), was evaluated in patients with advanced NSCLC.
METHODS


This expansion cohort of NCT02517398, an ongoing, phase 1, open-label trial, includes 80 patients with advanced NSCLC that progressed after platinum doublet therapy or after platinum-based adjuvant or neoadjuvant treatment and those who also have not received previous immunotherapy. Patients were randomized at a one-to-one ratio to receive either bintrafusp alfa 500 mg or the recommended phase 2 dosage of 1200 mg every 2 weeks. The primary end point was the best overall response (by Response Evaluation Criteria in Solid Tumors 1.1 as adjudicated by independent review committee) and was assessed by the objective response rate (ORR).
RESULTS


A total of 80 patients were randomized to receive bintrafusp alfa 500 or 1200 mg (n = 40 each). Median follow-up was 51.9 weeks (IQR, 19.6-74.0). The ORR in all patients was 21.3% (17 of 80). The ORR was 17.5% (seven of 40) and 25.0% (10 of 40) for the 500 mg dose and the 1200 mg dose (recommended phase 2 dose), respectively. At the 1200 mg dose, patients with PD-L1-positive and PD-L1-high (≥80% expression on tumor cells) had ORRs of 36.0% (10 of 27) and 85.7% (six of seven), respectively. Treatment-related adverse events occurred in 55 of the 80 patients (69%) and were graded as greater than or equal to 3 in 23 of the 80 patients (29%). Of the 80 patients, eight (10%) had a treatment-related adverse event that led to treatment discontinuation; no treatment-related deaths occurred.
CONCLUSIONS


Bintrafusp alfa had encouraging efficacy and manageable tolerability in patients with NSCLC previously treated with platinum.",2020,Treatment-related adverse events (TRAEs) occurred in 55/80 patients (69%) and were grade ≥3 in 23/80 patients (29%).,"['Eighty patients', 'patients with advanced non-small cell lung cancer (NSCLC', '80 patients with advanced NSCLC that progressed following platinum doublet therapy or after platinum-based adjuvant or neoadjuvant treatment who also have not received prior immunotherapy', 'patients with non-small cell lung cancer']",[],"['adverse events (TRAEs', 'objective response rate (ORR', 'ORR', 'overall response', 'efficacy and manageable tolerability', 'safety and efficacy']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]",[],"[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",80.0,0.165194,Treatment-related adverse events (TRAEs) occurred in 55/80 patients (69%) and were grade ≥3 in 23/80 patients (29%).,"[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'HI2O-CNIO Haematological Malignancies Clinical Research Unit (Hospital Universitario 12 de Octubre-CNIO), Universidad Complutense & Ciberonc, Madrid, Spain. Electronic address: lpazares@seom.org.'}, {'ForeName': 'Tae Min', 'Initials': 'TM', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Department of Clinical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Medical Oncology Department, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Dae Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Deparment of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.'}, {'ForeName': 'Chia-Chi', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Flor', 'Affiliation': 'Servicio de Oncología Médica, Hospital Universitario Virgen del Rocío, Seville, Spain.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Nicola', 'Affiliation': 'Unit of Immunotherapy and Anticancer Innovative Therapeutics, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Rosa Maria', 'Initials': 'RM', 'LastName': 'Alvarez', 'Affiliation': 'Department of Medical Oncology, Gregorio Marañon Hospital, Madrid, Spain.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Dussault', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts; a business of Merck KGaA, Darmstadt, Germany; Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Helwig', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Laureen S', 'Initials': 'LS', 'LastName': 'Ojalvo', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts; a business of Merck KGaA, Darmstadt, Germany; Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Gulley', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.03.003']
964,32173650,T-Cell Infiltration and Adaptive Treg Resistance in Response to Androgen Deprivation With or Without Vaccination in Localized Prostate Cancer.,"PURPOSE


Previous studies suggest that androgen deprivation therapy (ADT) promotes antitumor immunity in prostate cancer. Whether a vaccine-based approach can augment this effect remains unknown.
PATIENTS AND METHODS


We conducted a neoadjuvant, randomized study to quantify the immunologic effects of a GM-CSF-secreting allogeneic cellular vaccine in combination with low-dose cyclophosphamide (Cy/GVAX) followed by degarelix versus degarelix alone in patients with high-risk localized prostate adenocarcinoma who were planned for radical prostatectomy.
RESULTS


Both Cy/GVAX plus degarelix and degarelix alone led to significant increases in intratumoral CD8 +  T-cell infiltration and PD-L1 expression as compared with a cohort of untreated, matched controls. However, the CD8 +  T-cell infiltrate was accompanied by a proportional increase in regulatory T cells (Treg), suggesting that adaptive Treg resistance may dampen the immunogenicity of ADT. Although Cy/GVAX followed by degarelix was associated with a modest improvement in time-to-PSA progression and time-to-next treatment, as well as an increase in PD-L1, there was no difference in the CD8 +  T-cell infiltrate as compared with degarelix alone. Gene expression profiling demonstrated that  CHIT1 , a macrophage marker, was differentially upregulated with Cy/GVAX plus degarelix compared with degarelix alone.
CONCLUSIONS


Our results highlight that ADT with or without Cy/GVAX induces a complex immune response within the prostate tumor microenvironment. These data have important implications for combining ADT with immunotherapy. In particular, our finding that ADT increases both CD8 +  T cells and Tregs supports the development of regimens combining ADT with Treg-depleting agents in the treatment of prostate cancer.",2020,"Gene expression profiling demonstrated that CHIT1, a macrophage marker, was differentially upregulated with Cy/GVAX plus degarelix compared to degarelix alone.
","['prostate cancer', 'patients with high-risk localized prostate adenocarcinoma who were planned for radical prostatectomy', 'Localized Prostate Cancer']","['Androgen Deprivation', 'granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting allogeneic cellular vaccine', 'degarelix versus degarelix alone', 'cyclophosphamide (Cy/GVAX', 'ADT with or without Cy/GVAX', 'androgen deprivation therapy (ADT']","['PD-L1', 'CD8 T-cell infiltrate', 'time-to-PSA progression and time-to-next treatment', 'intratumoral CD8+ T cell infiltration and PD-L1 expression']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1455035', 'cui_str': 'degarelix'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.02347,"Gene expression profiling demonstrated that CHIT1, a macrophage marker, was differentially upregulated with Cy/GVAX plus degarelix compared to degarelix alone.
","[{'ForeName': 'Aleksandar Z', 'Initials': 'AZ', 'LastName': 'Obradovic', 'Affiliation': 'Columbia Center for Translational Immunology, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Dallos', 'Affiliation': 'Division of Hematology and Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Marianna L', 'Initials': 'ML', 'LastName': 'Zahurak', 'Affiliation': 'Department of Oncology and Biostatistics, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Partin', 'Affiliation': 'Department of Urology, Brady Urological Institute, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Schaeffer', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'Texas Urology Specialists, Dallas, Texas.'}, {'ForeName': 'Mohamad E', 'Initials': 'ME', 'LastName': 'Allaf', 'Affiliation': 'Department of Urology, Brady Urological Institute, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Nirschl', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Maryland.'}, {'ForeName': 'Carolyn G', 'Initials': 'CG', 'LastName': 'Chapman', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': ""O'Neal"", 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Durham', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Gunes', 'Initials': 'G', 'LastName': 'Guner', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Baena-Del Valle', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Ertunc', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'De Marzo', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'Columbia Center for Translational Immunology, Columbia University Irving Medical Center, New York, New York. cgd2139@cumc.columbia.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3372']
965,32173950,Randomised controlled trial of a treatment adherence programme for prisoners with mental health problems in Spain.,"The prevalence of psychiatric disorders is high among prisoners, who often need psychotropic medication, but compliance with treatment is often poor. This combination leads to poorer prisoner-patient health and increased health costs.The aim of this study was to test the impact of a treatment adherence programme (TAP) on medication adherence and subjective well-being among prisoners with mental health problems. We conducted a randomised controlled trial of a treatment adherence programme compared with treatment as usual (TAU) among 183 prisoners with mental health problems. Those in the TAP group showed greater treatment adherence and reported better subjective well-being with medication than those in the TAU group. We conclude that the treatment adherence of prisoners who require medication for mental health problems may be improved through specific intervention programmes. This could make a positive contribution to individual health and well-being.",2020,Those in the TAP group showed greater treatment adherence and reported better subjective well-being with medication than those in the TAU group.,"['183 prisoners with mental health problems', 'prisoners with mental health problems in Spain', 'prisoners who require medication for mental health problems', 'prisoners with mental health problems']","['treatment adherence programme', 'TAP', 'treatment adherence programme (TAP']","['treatment adherence', 'health costs']","[{'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}]","[{'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",183.0,0.0572278,Those in the TAP group showed greater treatment adherence and reported better subjective well-being with medication than those in the TAU group.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Muela', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of the Basque Country UPV/EHU, San Sebastián, Spain.'}, {'ForeName': 'Jone', 'Initials': 'J', 'LastName': 'Aliri', 'Affiliation': 'Department of Social Psychology and Behavioral Sciences Methodology, University of the Basque Country, San Sebastián, Spain.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Presa', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of the Basque Country UPV/EHU, San Sebastián, Spain.'}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'Gorostiaga', 'Affiliation': 'Department of Social Psychology and Behavioral Sciences Methodology, University of the Basque Country, San Sebastián, Spain.'}]",Criminal behaviour and mental health : CBMH,['10.1002/cbm.2142']
966,32162214,Cost-Effectiveness of IncobotulinumtoxinA in the Treatment of Sialorrhea in Patients with Various Neurological Conditions.,"INTRODUCTION


Sialorrhea is a common and debilitating symptom associated with neurological conditions, which can result in considerable physical and psychosocial complications. In Australia, management options are limited and further impeded by the lack of approved treatments. Whilst there is emerging evidence for the efficacy and tolerability of botulinum toxin (BoNT) for the treatment of sialorrhea in patients with neurological conditions, the cost-effectiveness of the treatment is yet to be established.
OBJECTIVES


To evaluate the cost-effectiveness of incobotulinumtoxinA for the treatment of chronic troublesome sialorrhea caused by various neurological conditions from the Australian healthcare perspective.
METHODS


A Markov state transition model was developed to perform a cost-utility analysis comparing incobotulinumtoxinA with standard of care (SoC). The model consisted of a hypothetical cohort of patients transiting between three severity-based health states, defined according to the Drooling Severity and Frequency Scale (DSFS), in 16-weekly cycles over 5 years. All clinical and utility inputs were sourced from a single placebo-controlled randomised clinical trial. Only direct healthcare costs were considered, and potential indirect costs such as carer's time and lost productivity were ignored. The primary outcome measure was the incremental cost per quality-adjusted life-year (QALY). Univariate and probabilistic sensitivity analyses were conducted.
RESULTS


The model demonstrated that proportionally more patients spent time in less severe sialorrhea health states in the incobotulinumtoxinA arm. For example, over the 5-year period, patients receiving incobotulinumtoxinA were estimated to spend 1.6 years with minimal or no sialorrhea, while no patients achieved this level of improvement under SoC. IncobotulinumtoxinA was shown to have an incremental cost per QALY gained of A$23,445 when compared with SoC.
CONCLUSIONS


The quality of life (QoL) of patients with sialorrhea caused by neurological conditions was considerably compromised. IncobotulinumtoxinA was shown to successfully alleviate sialorrhea and it was demonstrated to be a cost-effective intervention when compared with SoC alone.",2020,The model demonstrated that proportionally more patients spent time in less severe sialorrhea health states in the incobotulinumtoxinA arm.,"['patients with neurological conditions', 'Patients with Various Neurological Conditions']","['botulinum toxin (BoNT', 'incobotulinumtoxinA', 'IncobotulinumtoxinA', 'incobotulinumtoxinA with standard of care (SoC']","['severe sialorrhea health states', 'efficacy and tolerability', 'incremental cost per quality-adjusted life-year (QALY', 'quality of life (QoL', 'Drooling Severity and Frequency Scale (DSFS', 'neurological conditions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0034380'}, {'cui': 'C0013132', 'cui_str': 'Drooling'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",,0.0288848,The model demonstrated that proportionally more patients spent time in less severe sialorrhea health states in the incobotulinumtoxinA arm.,"[{'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Makino', 'Affiliation': 'THEMA Consulting Pty. Ltd., Sydney, Australia. kmakino@thema.net.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Mahant', 'Affiliation': 'Neurology, Westmead Hospital, Sydney, Australia.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Tilden', 'Affiliation': 'THEMA Consulting Pty. Ltd., Sydney, Australia.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Aghajanian', 'Affiliation': 'THEMA Consulting Pty. Ltd., Sydney, Australia.'}]",Neurology and therapy,['10.1007/s40120-020-00182-8']
967,30891657,Computerized neurocognitive training for improving dietary health and facilitating weight loss.,"Nearly 70% of Americans are overweight, in large part because of overconsumption of high-calorie foods such as sweets. Reducing sweets is difficult because powerful drives toward reward overwhelm inhibitory control (i.e., the ability to withhold a prepotent response) capacities. Computerized inhibitory control trainings (ICTs) have shown positive outcomes, but impact on real-world health behavior has been variable, potentially because of limitations inherent in existing paradigms, e.g., low in frequency, intrinsic enjoyment, personalization, and ability to adapt to increasing ability. The present study aimed to assess the feasibility, acceptability, and efficacy of a gamified and non-gamified, daily, personalized, and adaptive ICT designed to facilitate weight loss by targeting consumption of sweets. Participants (N = 106) were randomized to one of four conditions in a 2 (gamified vs. non-gamified) by 2 (ICT vs. sham) factorial design. Participants were prescribed a no-added-sugar diet and completed 42 daily, at-home trainings, followed by two weekly booster trainings. Results indicated that the ICTs were feasible and acceptable. Surprisingly, compliance to the 44 trainings was excellent (88.8%) and equivalent across both gamified and non-gamified conditions. As hypothesized, the impact of ICT on weight loss was moderated by implicit preference for sweet foods [F(1,95) = 6.17, p = .02] such that only those with higher-than-average implicit preference benefited (8-week weight losses for ICT were 3.1% vs. 2.2% for sham). A marginally significant effect was observed for gamification to reduce the impact of ICT. Implications of findings for continued development of ICTs to impact health behavior are discussed.",2019,"Surprisingly, compliance to the 44 trainings was excellent (88.8%) and equivalent across both gamified and non-gamified conditions.",['Participants (N\u2009=\u2009106'],"['gamified and non-gamified, daily, personalized, and adaptive ICT', 'Computerized neurocognitive training', 'Computerized inhibitory control trainings (ICTs']","['dietary health and facilitating weight loss', 'feasibility, acceptability, and efficacy', 'weight loss']",[],"[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",106.0,0.0424756,"Surprisingly, compliance to the 44 trainings was excellent (88.8%) and equivalent across both gamified and non-gamified conditions.","[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Drexel University, Philadelphia, USA. emf27@drexel.edu.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Manasse', 'Affiliation': 'Drexel University, Philadelphia, USA.'}, {'ForeName': 'Diane H', 'Initials': 'DH', 'LastName': 'Dallal', 'Affiliation': 'Drexel University, Philadelphia, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Crochiere', 'Affiliation': 'Drexel University, Philadelphia, USA.'}, {'ForeName': 'Caitlin M', 'Initials': 'CM', 'LastName': 'Loyka', 'Affiliation': 'Drexel University, Philadelphia, USA.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Drexel University, Philadelphia, USA.'}, {'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Juarascio', 'Affiliation': 'Drexel University, Philadelphia, USA.'}, {'ForeName': 'Katrijn', 'Initials': 'K', 'LastName': 'Houben', 'Affiliation': 'Maastricht University, Maastricht, The Netherlands.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00024-5']
968,30903442,Adapting a self-affirmation intervention for use in a mobile application for smokers.,"Self-affirmation interventions can reduce defensive responses to threats to the self, but have had limited reach to the general population. We sought to create an effective and feasible version of the Kindness Questionnaire self-affirmation intervention for use on a mobile device outside the traditional university laboratory setting and by non-student participants. In an online experiment, 603 cigarette smokers (M age = 37.5 years, SD = 10.2) were randomly assigned to one of six conditions in a 2 (Self-Affirmation: Self-Affirmation, No Self-Affirmation Control) × 3 (Example Type: Written, Imagined, No Examples) fully-crossed design. Participants read a message about the health harms of smoking. None of the self-affirmation variations were effective or feasible: the self-affirmation showed null effects on the primary outcomes of message acceptance, perceived message effectiveness, and reactance. It also backfired by reducing intentions to quit smoking and risk perceptions. Participants spent little time reading the health message, and those in the written self-affirmation condition infrequently provided detailed responses. Translating interventions developed and tested for efficacy in laboratory settings to ""real-world"" settings is necessary but challenging.",2019,"None of the self-affirmation variations were effective or feasible: the self-affirmation showed null effects on the primary outcomes of message acceptance, perceived message effectiveness, and reactance.","['37.5\xa0years, SD\u2009=\u200910.2', '603 cigarette smokers (M age ', 'smokers', 'mobile device outside the traditional university laboratory setting and by non-student participants']",['Kindness Questionnaire self-affirmation intervention'],"['message acceptance, perceived message effectiveness, and reactance']","[{'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",603.0,0.0144147,"None of the self-affirmation variations were effective or feasible: the self-affirmation showed null effects on the primary outcomes of message acceptance, perceived message effectiveness, and reactance.","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Taber', 'Affiliation': 'Department of Psychological Sciences, Kent State University, Kent, OH, 44242-0001, USA. jtaber1@kent.edu.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'McQueen', 'Affiliation': 'School of Medicine, Washington University in Saint Louis, Saint Louis, MO, 63110, USA.'}, {'ForeName': 'Nicolle', 'Initials': 'N', 'LastName': 'Simonovic', 'Affiliation': 'Department of Psychological Sciences, Kent State University, Kent, OH, 44242-0001, USA.'}, {'ForeName': 'Erika A', 'Initials': 'EA', 'LastName': 'Waters', 'Affiliation': 'School of Medicine, Washington University in Saint Louis, Saint Louis, MO, 63110, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00028-1']
969,32162502,"Effect of core strength training on balance, vertical jump height and throwing velocity in adolescent male handball players.","BACKGROUND


The aim of this study was to examine the effects of core strength training (CST) on dynamic balance and vertical jump height, and throwing velocity in handball players.
METHODS


Twenty male handball players (mean age 14.90±0.44 years) participated in this study. The players randomly divided into two groups as CST and control (CON) groups. Dynamic balance, vertical jump, and throwing velocity were measured before and after a six-week CST.
RESULTS


Significant differences were found at anterior (P=0.009) and posteromedial (P=0.017) directions of the Star Excursion Balance Test (SEBT) in only CST group. There were significant improvement in vertical jump height of participants compared to pre-test scores in both CST (P=0.047) and CON group (P=0.013). No significant difference was found for throwing velocity compared with pre-test in both groups. There were no significant differences in all parameters when CST and CON groups were compared (P>0.05).
CONCLUSIONS


The results of the present study indicated that a 6-week CST did not improve dynamic balance, vertical jump height and throwing velocity in adolescent male handball players. We believe that longer CST programs may provide significant benefits.",2020,"RESULTS


Significant differences were found at anterior (p=0.009) and posteromedial (p=0.017) directions of the Star Excursion Balance Test (SEBT) in only CST group.","['Twenty male handball players (mean age 14.90±0.44 years) participated in this study', 'adolescent male handball players', 'handball players']","['CST', 'CON', 'CST and control (CON', 'core strength training', 'core strength training (CST']","['Dynamic balance, vertical jump, and throwing velocity', 'balance, vertical jump height and throwing velocity', 'throwing velocity', 'dynamic balance, vertical jump height and throwing velocity', 'vertical jump height', 'dynamic balance and vertical jump height, and throwing velocity', 'Star Excursion Balance Test (SEBT']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0560512', 'cui_str': 'Does throw (finding)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",20.0,0.0172039,"RESULTS


Significant differences were found at anterior (p=0.009) and posteromedial (p=0.017) directions of the Star Excursion Balance Test (SEBT) in only CST group.","[{'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Ozmen', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Karabuk University, Karabuk, Turkey - tarikozmen@karabuk.edu.tr.'}, {'ForeName': 'Mert', 'Initials': 'M', 'LastName': 'Aydogmus', 'Affiliation': 'Hasan Dogan School of Physical Education and Health, Karabuk University, Karabuk, Turkey.'}, {'ForeName': 'Metehan', 'Initials': 'M', 'LastName': 'Yana', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Karabuk University, Karabuk, Turkey.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Simsek', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Karabuk University, Karabuk, Turkey.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10382-7']
970,32162503,A 12-month continuous and intermittent high-impact exercise intervention and its effects on bone mineral density in early postmenopausal women: a feasibility randomized controlled trial.,"BACKGROUND


Intermittent mechanical loading generates greater bone adaptations than continuous mechanical loading in rodents but has never been evaluated in humans. This study aimed to evaluate the feasibility of a continuous and intermittent countermovement jump (CMJ) intervention for attenuating early postmenopausal BMD loss.
METHODS


41 healthy early postmenopausal women (age=54.6±3.4 years) were randomly assigned to a continuous countermovement jumping group, an intermittent countermovement jumping group or a control group for 12 months. Adherence and dropout rates were recorded along with bone mineral density (BMD) at lumbar spine, femoral neck and trochanter sites at baseline, 6 months and 12 months.
RESULTS


28 participants completed the study. Dropout rate during the intervention (from the initiation of exercise) was 36% from continuous and 38% from intermittent countermovement jumping groups. For the participants that completed the intervention, adherence was 60.0±46.8% for continuous and 68.5±32.3% for intermittent countermovement jumping. The control group lost significant lumbar spine BMD (% difference=-2.7 [95%CI: -3.9 to -1.4]) and femoral neck BMD (% difference=-3.0% [95%CI: -5.1 to -0.8]). There was no statistically significant change in BMD for either countermovement jumping group. There was no statistically significant difference in BMD change between continuous or intermittent countermovement jumping groups when compared with the control group.
CONCLUSIONS


Adherence and dropout rates were in line with previous similar interventions. To evaluate the effect of continuous and intermittent exercise on BMD, future studies should focus on maintaining participant engagement and adherence to the exercise intervention.",2020,"There was no statistically significant difference in BMD change between continuous or intermittent countermovement jumping groups when compared with the control group.
","['early postmenopausal women', '41 healthy early postmenopausal women (age = 54.6 ± 3.4 years', '28 participants completed the study']","['intermittent high-impact exercise intervention', 'continuous countermovement jumping group, an intermittent countermovement jumping group or a control group for 12 months', 'continuous and intermittent high-impact exercise intervention', 'continuous and intermittent exercise', 'continuous and intermittent countermovement jump (CMJ) intervention']","['Dropout rate', 'bone mineral density (BMD) at lumbar spine, femoral neck and trochanter sites', 'BMD', 'lumbar spine BMD', 'bone mineral density', 'femoral neck BMD', 'early postmenopausal BMD loss', 'BMD change', 'Adherence and dropout rates']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0162370', 'cui_str': 'Trochanter'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",41.0,0.109791,"There was no statistically significant difference in BMD change between continuous or intermittent countermovement jumping groups when compared with the control group.
","[{'ForeName': 'Gallin J', 'Initials': 'GJ', 'LastName': 'Montgomery', 'Affiliation': 'Division of Musculoskeletal Science and Sports Medicine, Department of Sport and Exercise Sciences, Manchester Metropolitan University, Manchester, UK - g.montgomery@mmu.ac.uk.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Abt', 'Affiliation': 'Department of Sport, Health and Exercise Science, The University of Hull, Hull, UK.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Dobson', 'Affiliation': 'School of Engineering and Computer Science, The University of Hull, Hull, UK.'}, {'ForeName': 'Will J', 'Initials': 'WJ', 'LastName': 'Evans', 'Affiliation': 'Department of Sport and Exercise Sciences, Faculty of Health Sciences and Wellbeing, University of Sunderland, Sunderland, UK.'}, {'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Aye', 'Affiliation': 'Center for Metabolic Bone Disease, Hull Royal Infirmary, Hull, UK.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Ditroilo', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10412-2']
971,31011944,Pilot randomised controlled trial of a brief mindfulness-based intervention for those with persistent pain.,"A pilot-randomised controlled trial (RCT) examined the effects of a brief mindfulness-based intervention (MBI) on persistent pain patients and assessed the feasibility of conducting a definitive RCT. A brief (15 min) mindfulness body-scan audio was compared with an active control administered in a clinic and then used independently over 1 month. Immediate effects of the intervention were assessed with brief measures of pain severity, distraction and distress. Assessments at baseline, 1 week and 1 month included pain severity and interference, mood, pain-catastrophizing, mindfulness, self-efficacy, quality of life and intervention acceptability. Of 220 referred patients, 147 were randomised and 71 completed all assessments. There were no significant immediate intervention effects. There were significant positive effects for ratings of intervention 'usefulness' at 1 week (p = 0.044), and pain self-efficacy at 1 month (p = 0.039) for the MBI group compared with control. Evidently, it is feasible to recruit persistent pain patients to a brief MBI study. Strategies are needed to maximise retention of participants.Trial registration Current controlled trials ISRCTN61538090. Registered 20 April 2015.",2019,"There were significant positive effects for ratings of intervention 'usefulness' at 1 week (p = 0.044), and pain self-efficacy at 1 month (p = 0.039) for the MBI group compared with control.","['those with persistent pain', 'persistent pain patients', 'Of 220 referred patients, 147 were randomised and 71 completed all assessments']","['brief mindfulness-based intervention (MBI', 'brief mindfulness-based intervention']","['pain self-efficacy', 'pain severity, distraction and distress', 'pain severity and interference, mood, pain-catastrophizing, mindfulness, self-efficacy, quality of life and intervention acceptability']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0034380'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0956365,"There were significant positive effects for ratings of intervention 'usefulness' at 1 week (p = 0.044), and pain self-efficacy at 1 month (p = 0.039) for the MBI group compared with control.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Howarth', 'Affiliation': ""Population Health Research Institute, St George's, University of London, Cranmer Terrace, London, SW17 0RE, UK. p1306542@sgul.ac.uk.""}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Riaz', 'Affiliation': ""Population Health Research Institute, St George's, University of London, Cranmer Terrace, London, SW17 0RE, UK.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Perkins-Porras', 'Affiliation': ""Institute of Medical and Biomedical Education, St George's, University of London, London, UK.""}, {'ForeName': 'Jared G', 'Initials': 'JG', 'LastName': 'Smith', 'Affiliation': ""Population Health Research Institute, St George's, University of London, Cranmer Terrace, London, SW17 0RE, UK.""}, {'ForeName': 'Jeevakan', 'Initials': 'J', 'LastName': 'Subramaniam', 'Affiliation': ""Population Health Research Institute, St George's, University of London, Cranmer Terrace, London, SW17 0RE, UK.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Copland', 'Affiliation': ""Persistent Pain Service, St George's Hospital, London, UK.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Hurley', 'Affiliation': ""Faculty of Health, Social Care and Education, Kingston University and St George's, University of London, London, UK.""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Beith', 'Affiliation': ""Faculty of Health, Social Care and Education, Kingston University and St George's, University of London, London, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ussher', 'Affiliation': ""Population Health Research Institute, St George's, University of London, Cranmer Terrace, London, SW17 0RE, UK.""}]",Journal of behavioral medicine,['10.1007/s10865-019-00040-5']
972,32162103,Cannabinoid modulation of corticolimbic activation to threat in trauma-exposed adults: a preliminary study.,"RATIONALE


Excessive fear and anxiety, coupled with corticolimbic dysfunction, are core features of stress- and trauma-related psychopathology, such as posttraumatic stress disorder (PTSD). Interestingly, low doses of ∆ 9 -tetrahydrocannabinol (THC) can produce anxiolytic effects, reduce threat-related amygdala activation, and enhance functional coupling between the amygdala and medial prefrontal cortex and adjacent rostral cingulate cortex (mPFC/rACC) during threat processing in healthy adults. Together, these findings suggest the cannabinoid system as a potential pharmacological target in the treatment of excess fear and anxiety. However, the effects of THC on corticolimbic functioning in response to threat have not be investigated in adults with trauma-related psychopathology.
OBJECTIVE


To address this gap, the present study tests the effects of an acute low dose of THC on corticolimbic responses to threat in three groups of adults: (1) non-trauma-exposed healthy controls (HC; n = 25), (2) trauma-exposed adults without PTSD (TEC; n = 27), and (3) trauma-exposed adults with PTSD (n = 19).
METHODS


Using a randomized, double-blind, placebo-controlled, between-subjects design, 71 participants were randomly assigned to receive either THC or placebo (PBO) and subsequently completed a well-established threat processing paradigm during functional magnetic resonance imaging.
RESULTS


In adults with PTSD, THC lowered threat-related amygdala reactivity, increased mPFC activation during threat, and increased mPFC-amygdala functional coupling.
CONCLUSIONS


These preliminary data suggest that THC modulates threat-related processing in trauma-exposed individuals with PTSD, which may prove advantageous as a pharmacological approach to treating stress- and trauma-related psychopathology.",2020,"In adults with PTSD, THC lowered threat-related amygdala reactivity, increased mPFC activation during threat, and increased mPFC-amygdala functional coupling.
","['trauma-exposed adults', 'adults with trauma-related psychopathology', 'healthy adults', 'three groups of adults: (1) non-trauma-exposed healthy controls (HC; n\xa0=\u200925), (2) trauma-exposed adults without PTSD (TEC; n\xa0=\u200927), and (3) trauma-exposed adults with PTSD (n\xa0=\u200919', '71 participants']","['placebo', 'tetrahydrocannabinol (THC', 'THC or placebo (PBO) and subsequently completed a well-established threat processing paradigm during functional magnetic resonance imaging', 'THC']","['mPFC activation', 'mPFC-amygdala functional coupling']","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",71.0,0.078447,"In adults with PTSD, THC lowered threat-related amygdala reactivity, increased mPFC activation during threat, and increased mPFC-amygdala functional coupling.
","[{'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Rabinak', 'Affiliation': 'Department of Pharmacy Practice, Wayne State University, 259 Mack Ave, Suite 2190, Detroit, MI, 48201, USA. rabinak@wayne.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Blanchette', 'Affiliation': 'Department of Pharmacy Practice, Wayne State University, 259 Mack Ave, Suite 2190, Detroit, MI, 48201, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Zabik', 'Affiliation': 'Department of Pharmacy Practice, Wayne State University, 259 Mack Ave, Suite 2190, Detroit, MI, 48201, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': 'Department of Pharmacy Practice, Wayne State University, 259 Mack Ave, Suite 2190, Detroit, MI, 48201, USA.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Marusak', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Allesandra', 'Initials': 'A', 'LastName': 'Iadipaolo', 'Affiliation': 'Department of Pharmacy Practice, Wayne State University, 259 Mack Ave, Suite 2190, Detroit, MI, 48201, USA.'}, {'ForeName': 'Farrah', 'Initials': 'F', 'LastName': 'Elrahal', 'Affiliation': 'Department of Pharmacy Practice, Wayne State University, 259 Mack Ave, Suite 2190, Detroit, MI, 48201, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05499-8']
973,32160096,Randomized Phase IIB Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for Locally Advanced Esophageal Cancer.,"PURPOSE


Whether dosimetric advantages of proton beam therapy (PBT) translate to improved clinical outcomes compared with intensity-modulated radiation therapy (IMRT) remains unclear. This randomized trial compared total toxicity burden (TTB) and progression-free survival (PFS) between these modalities for esophageal cancer.
METHODS


This phase IIB trial randomly assigned patients to PBT or IMRT (50.4 Gy), stratified for histology, resectability, induction chemotherapy, and stage. The prespecified coprimary end points were TTB and PFS. TTB, a composite score of 11 distinct adverse events (AEs), including common toxicities as well as postoperative complications (POCs) in operated patients, quantified the extent of AE severity experienced over the duration of 1 year following treatment. The trial was conducted using Bayesian group sequential design with three planned interim analyses at 33%, 50%, and 67% of expected accrual (adjusted for follow-up).
RESULTS


This trial (commenced April 2012) was approved for closure and analysis upon activation of NRG-GI006 in March 2019, which occurred immediately prior to the planned 67% interim analysis. Altogether, 145 patients were randomly assigned (72 IMRT, 73 PBT), and 107 patients (61 IMRT, 46 PBT) were evaluable. Median follow-up was 44.1 months. Fifty-one patients (30 IMRT, 21 PBT) underwent esophagectomy; 80% of PBT was passive scattering. The posterior mean TTB was 2.3 times higher for IMRT (39.9; 95% highest posterior density interval, 26.2-54.9) than PBT (17.4; 10.5-25.0). The mean POC score was 7.6 times higher for IMRT (19.1; 7.3-32.3) versus PBT (2.5; 0.3-5.2). The posterior probability that mean TTB was lower for PBT compared with IMRT was 0.9989, which exceeded the trial's stopping boundary of 0.9942 at the 67% interim analysis. The 3-year PFS rate (50.8%  v  51.2%) and 3-year overall survival rates (44.5%  v  44.5%) were similar.
CONCLUSION


For locally advanced esophageal cancer, PBT reduced the risk and severity of AEs compared with IMRT while maintaining similar PFS.",2020,"The posterior mean TTB was 2.3 times higher for IMRT (39.9; 95% highest posterior density interval, 26.2-54.9) than PBT (17.4; 10.5-25.0).","['145 patients were randomly assigned (72 IMRT, 73 PBT), and 107 patients (61 IMRT, 46 PBT) were evaluable', 'Locally Advanced Esophageal Cancer']","['esophagectomy', 'PBT or IMRT', 'Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy', 'PBT', 'IMRT', 'proton beam therapy (PBT', 'intensity-modulated radiation therapy (IMRT']","['posterior mean TTB', 'TTB and PFS', 'total toxicity burden (TTB) and progression-free survival (PFS', '3-year PFS rate', '3-year overall survival rates', 'posterior probability that mean TTB', 'mean POC score', 'TTB, a composite score of 11 distinct adverse events (AEs), including common toxicities as well as postoperative complications (POCs']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}]","[{'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0436226', 'cui_str': 'Proton Beam Radiation Therapy'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",145.0,0.283472,"The posterior mean TTB was 2.3 times higher for IMRT (39.9; 95% highest posterior density interval, 26.2-54.9) than PBT (17.4; 10.5-25.0).","[{'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Hobbs', 'Affiliation': 'Quantitative Health Sciences, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Verma', 'Affiliation': 'Department of Radiation Oncology, Allegheny General Hospital, Pittsburgh, PA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Tidwell', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Smith', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xiudong', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Corsini', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mok', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Luyang', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China.""}, {'ForeName': 'Ritsuko U', 'Initials': 'RU', 'LastName': 'Komaki', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Joe Y', 'Initials': 'JY', 'LastName': 'Chang', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Chun', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Melenda D', 'Initials': 'MD', 'LastName': 'Jeter', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Swisher', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jaffer A', 'Initials': 'JA', 'LastName': 'Ajani', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Blum-Murphy', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Ara A', 'Initials': 'AA', 'LastName': 'Vaporciyan', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Reza J', 'Initials': 'RJ', 'LastName': 'Mehran', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'Koong', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Saumil J', 'Initials': 'SJ', 'LastName': 'Gandhi', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Wayne L', 'Initials': 'WL', 'LastName': 'Hofstetter', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Theodore S', 'Initials': 'TS', 'LastName': 'Hong', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Delaney', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Radhe', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02503']
974,30980223,A web-based physical activity intervention benefits persons with low self-efficacy in COPD: results from a randomized controlled trial.,"Promoting physical activity (PA) is of top priority in chronic obstructive pulmonary disease (COPD). This study examines the influence of an internet-delivered intervention on the relationship between exercise self-efficacy and changes in PA, physical health, and exercise capacity in COPD. 112 U.S. Veterans with COPD were randomized to either a comparison (pedometer alone) or an intervention group (pedometer plus access to an internet-mediated PA intervention). There was a significant interaction between baseline exercise self-efficacy and randomization group on change in PA. In the comparison group, there was a significant relationship between higher baseline exercise self-efficacy and greater change in PA, whereas in the intervention group, improvements in PA were independent of level of baseline self-efficacy. Similar patterns were found with physical health and exercise capacity as outcomes. The use of an internet-mediated intervention significantly benefited persons with COPD who had low baseline self-efficacy to increase PA and physical health.Clinical trial registration The randomized clinical trial was registered on ClinicalTrials.gov (NCT01772082).",2019,The use of an internet-mediated intervention significantly benefited persons with COPD who had low baseline self-efficacy to increase PA and physical health.,"['chronic obstructive pulmonary disease (COPD', 'persons with COPD who had low baseline self-efficacy to increase PA and physical health', 'benefits persons with low self-efficacy in COPD', '112 U.S. Veterans with COPD']","['A web-based physical activity intervention', 'internet-mediated intervention', 'internet-delivered intervention', 'comparison (pedometer alone) or an intervention group (pedometer plus access to an internet-mediated PA intervention']",['higher baseline exercise self-efficacy and greater change in PA'],"[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0817305,The use of an internet-mediated intervention significantly benefited persons with COPD who had low baseline self-efficacy to increase PA and physical health.,"[{'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Robinson', 'Affiliation': 'Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, USA. stephanie.robinson5@va.gov.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Shimada', 'Affiliation': 'Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, USA.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'Quigley', 'Affiliation': 'Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, USA.'}, {'ForeName': 'Marilyn L', 'Initials': 'ML', 'LastName': 'Moy', 'Affiliation': 'VA Boston Healthcare System, Boston, MA, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00042-3']
975,30355775,Effect of Lanreotide Depot/Autogel on Urinary 5-Hydroxyindoleacetic Acid and Plasma Chromogranin A Biomarkers in Nonfunctional Metastatic Enteropancreatic Neuroendocrine Tumors.,"BACKGROUND


Urinary 5-hydroxyindoleacetic acid (5-HIAA) is an established biomarker in neuroendocrine tumors and carcinoid syndrome; however, its role in nonfunctional neuroendocrine tumors is not defined. We present post hoc data on urinary 5-HIAA and plasma chromogranin A (CgA) from the CLARINET study.
METHODS


Patients with well- or moderately differentiated, nonfunctioning, locally advanced or metastatic enteropancreatic neuroendocrine tumors were randomized to deep subcutaneous lanreotide depot/autogel 120 mg or placebo once every 28 days for 96 weeks. Tumor response, evaluated centrally (RECIST 1.0), and progression-free survival (PFS) were assessed by treatment and biochemical response, defined as (a) baseline >upper limit of normal (ULN, 41.6 μmol per day 5-HIAA; 98.1 μg/L CgA) and (b) ≥50% decrease from baseline and to ≤ULN value on study.
RESULTS


Forty-eight percent (82 of 171; lanreotide,  n  = 45; placebo,  n  = 37) and 66% (129 of 195; lanreotide,  n  = 65; placebo,  n  = 64) of randomized patients had 5-HIAA and CgA > ULN at baseline. Among patients with >ULN baseline values who did not progress after 96 weeks of treatment, significantly greater reductions in 5-HIAA and CgA were observed in lanreotide-treated versus placebo-treated patients throughout the study (all  p  < .05). PFS was significantly prolonged among 5-HIAA responders versus nonresponders (median not reached vs. 16.2 months,  p  < .0001; hazard ratio [HR] = 0.21, 95% confidence interval [CI], 0.09-0.48) and CgA responders versus nonresponders (median not reached vs. 16.2 months,  p  = .0070; HR = 0.30, 95% CI, 0.12-0.76), regardless of treatment arm. PFS was also significantly prolonged among lanreotide-treated 5-HIAA responders versus nonresponders ( p  = .0071) but was not significantly different among placebo-treated 5-HIAA responders versus nonresponders. There were no significant differences in PFS between lanreotide-treated CgA responders versus nonresponders or between placebo-treated CgA responders versus nonresponders.
CONCLUSIONS


The 5-HIAA findings are noteworthy because they occurred in patients with nonfunctioning enteropancreatic neuroendocrine tumors. Monitoring 5-HIAA and CgA may be useful when treating patients with nonfunctional neuroendocrine tumors.
IMPLICATIONS FOR PRACTICE


Current guidelines focus only on the monitoring of 5-hydroxyindoleacetic acid (5-HIAA) in the diagnosis and management of functional neuroendocrine tumors with carcinoid syndrome. The current post hoc analysis of patients with nonfunctional enteropancreatic neuroendocrine tumors in the CLARINET study demonstrated that measuring and following both 5-HIAA and chromogranin A as biomarkers of disease progression may be useful in the management of patients with nonfunctional neuroendocrine tumors.",2019,"There were no significant differences in PFS between lanreotide-treated CgA responders versus nonresponders or between placebo-treated CgA responders versus nonresponders.
","['Nonfunctional Metastatic Enteropancreatic Neuroendocrine Tumors', 'functional neuroendocrine tumors with carcinoid syndrome', 'Patients with well- or moderately differentiated, nonfunctioning, locally advanced or metastatic enteropancreatic neuroendocrine tumors', 'patients with nonfunctional neuroendocrine tumors', 'patients with nonfunctional enteropancreatic neuroendocrine tumors', 'patients with nonfunctioning enteropancreatic neuroendocrine tumors']","['5-hydroxyindoleacetic acid (5-HIAA', 'Lanreotide Depot/Autogel', 'placebo', 'deep subcutaneous lanreotide depot/autogel 120 mg or placebo']","['5-HIAA and CgA', '5-HIAA and CgA > ULN', 'Urinary 5-Hydroxyindoleacetic Acid and Plasma Chromogranin', 'PFS', 'urinary 5-HIAA and plasma chromogranin A (CgA', 'Tumor response, evaluated centrally (RECIST 1.0), and progression-free survival (PFS']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine Tumors'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0024586', 'cui_str': 'Malignant Carcinoid Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205616', 'cui_str': 'Moderately differentiated (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0020361', 'cui_str': '5-HIAA'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0020361', 'cui_str': '5-HIAA'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0008586', 'cui_str': 'Granins'}, {'cui': 'C0055633', 'cui_str': 'Secretory Protein I, Parathyroid Gland'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.133669,"There were no significant differences in PFS between lanreotide-treated CgA responders versus nonresponders or between placebo-treated CgA responders versus nonresponders.
","[{'ForeName': 'Marianne E', 'Initials': 'ME', 'LastName': 'Pavel', 'Affiliation': 'Charité University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Alexandria T', 'Initials': 'AT', 'LastName': 'Phan', 'Affiliation': 'University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Wolin', 'Affiliation': 'Tisch Cancer Institute, Mount Sinai School of Medicine, New York New York, USA.'}, {'ForeName': 'Beloo', 'Initials': 'B', 'LastName': 'Mirakhur', 'Affiliation': 'Ipsen Biopharmaceuticals, Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Nilani', 'Initials': 'N', 'LastName': 'Liyanage', 'Affiliation': 'Ipsen, Les Ulis, France.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Pitman Lowenthal', 'Affiliation': 'Ipsen Biopharmaceuticals, Basking Ridge, New Jersey, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Fisher', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Aaron I', 'Initials': 'AI', 'LastName': 'Vinik', 'Affiliation': 'Eastern Virginia Medical School, Norfolk, Virginia, USA vinikai@evms.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2018-0217']
976,32160766,Neural Insensitivity to the Effects of Hunger in Women Remitted From Anorexia Nervosa.,"OBJECTIVE


Anorexia nervosa has the highest mortality rate of any psychiatric condition, yet the pathophysiology of this disorder and its primary symptom, extreme dietary restriction, remains poorly understood. In states of hunger relative to satiety, the rewarding value of food stimuli normally increases to promote eating, yet individuals with anorexia nervosa avoid food despite emaciation. This study's aim was to examine potential neural insensitivity to these effects of hunger in anorexia nervosa.
METHODS


At two scanning sessions scheduled 24 hours apart, one after a 16-hour fast and one after a standardized meal, 26 women who were in remission from anorexia nervosa (to avoid the confounding effects of malnutrition) and 22 matched control women received tastes of sucrose solution or ionic water while functional MRI data were acquired. Within a network of interest responsible for food valuation and transforming taste signals into motivation to eat, the authors compared groups across conditions on blood-oxygen-level-dependent (BOLD) signal and task-based functional connectivity.
RESULTS


Participants in the two groups had similar BOLD responses to sucrose and water tastants. A group-by-condition interaction in the ventral caudal putamen indicated that hunger had opposite effects on tastant response in the control group and the remitted anorexia nervosa group, with an increase and a decrease, respectively, in BOLD response when hungry. Hunger had a similar opposite effect on insula-to-ventral caudal putamen functional connectivity in the remitted anorexia nervosa group compared with the control group. Exploratory analyses indicated that lower caudate response to tastants when hungry was associated with higher scores on harm avoidance among participants in the remitted anorexia nervosa group.
CONCLUSIONS


Reduced recruitment of neural circuitry that translates taste stimulation to motivated eating behavior when hungry may facilitate food avoidance and prolonged periods of extremely restricted food intake in anorexia nervosa.",2020,"Exploratory analyses indicated that lower caudate response to tastants when hungry was associated with higher scores on harm avoidance among participants in the remitted anorexia nervosa group.
","['26 women who were in remission from anorexia nervosa (to avoid the confounding effects of malnutrition) and 22 matched control women received', 'anorexia nervosa', 'Anorexia nervosa', 'Women Remitted From Anorexia Nervosa']",['tastes of sucrose solution or ionic water while functional MRI data'],"['insula-to-ventral caudal putamen functional connectivity', 'BOLD responses to sucrose and water tastants', 'tastant response', 'blood-oxygen-level-dependent (BOLD) signal and task-based functional connectivity', 'BOLD response']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]","[{'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0034169', 'cui_str': 'Nucleus Putamen'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",26.0,0.0655501,"Exploratory analyses indicated that lower caudate response to tastants when hungry was associated with higher scores on harm avoidance among participants in the remitted anorexia nervosa group.
","[{'ForeName': 'Walter H', 'Initials': 'WH', 'LastName': 'Kaye', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Wierenga', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bischoff-Grethe', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Berner', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Alice V', 'Initials': 'AV', 'LastName': 'Ely', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Ursula F', 'Initials': 'UF', 'LastName': 'Bailer', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Paulus', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Fudge', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}]",The American journal of psychiatry,['10.1176/appi.ajp.2019.19030261']
977,31981369,Interventions for chronic pruritus of unknown origin.,"BACKGROUND


Pruritus is a sensation that leads to the desire to scratch; its origin is unknown in 8% to 15% of affected patients. The prevalence of chronic pruritus of unknown origin (CPUO) in individuals with generalised pruritus ranges from 3.6% to 44.5%, with highest prevalence among the elderly. When the origin of pruritus is known, its management may be straightforward if an effective treatment for the causal disease is available. Treatment of CPUO is particularly difficult due to its unknown pathophysiology.
OBJECTIVES


To assess the effects of interventions for CPUO in adults and children.
SEARCH METHODS


We searched the following up to July 2019: Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and trials registries. We checked the reference lists of included studies for additional references to relevant trials.
SELECTION CRITERIA


We sought to include randomised controlled trials and quasi-randomised controlled trials that assessed interventions for CPUO, as defined in category VI ('Other pruritus of undetermined origin, or chronic pruritus of unknown origin') of the International Forum for the Study of Itch (IFSI) classification, in children and adults. Eligible interventions were non-pharmacological or topical or systemic pharmacological interventions, and eligible comparators were another active treatment, placebo, sham procedures, or no treatment or equivalent (e.g. waiting list).
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane. Our primary outcomes were 'Patient- or parent-reported pruritus intensity' and 'Adverse events'. Our secondary outcomes were 'Health-related quality of life', 'Sleep disturbances', 'Depression', and 'Patient satisfaction'. We used GRADE to assess the certainty of evidence.
MAIN RESULTS


We found there was an absence of evidence for the main interventions of interest: emollient creams, cooling lotions, topical corticosteroids, topical antidepressants, systemic antihistamines, systemic antidepressants, systemic anticonvulsants, and phototherapy. We included one study with 257 randomised (253 analysed) participants, aged 18 to 65 years; 60.6% were female. This study investigated the safety and efficacy of three different doses of oral serlopitant (5 mg, 1 mg, and 0.25 mg, once daily for six weeks) compared to placebo for severe chronic pruritus; 25 US centres participated (clinical research centres and universities). All outcomes were measured at the end of treatment (six weeks from baseline), except adverse events, which were monitored throughout. A pharmaceutical company funded this study. Fifty-five per cent of participants suffered from CPUO, and approximately 45% presented a dermatological diagnosis (atopic dermatitis/eczema 37.3%, psoriasis 6.7%, acne 3.6%, among other diagnoses). We unsuccessfully attempted to retrieve outcome data from study authors for the subgroup of participants with CPUO. Participants had pruritus for six weeks or longer. Total study duration was 10 weeks. Participants who received serlopitant 5 mg may have a greater rate of relief of patient-reported pruritus intensity as measured by the visual analogue scale (VAS; a reduction in VAS score indicates improvement) compared to placebo (126 participants, risk ratio (RR) 2.06, 95% confidence interval (CI) 1.27 to 3.35; low-certainty evidence). We are uncertain of the effects of serlopitant 5 mg compared to placebo on the following outcomes due to very low-certainty evidence: adverse events (127 participants; RR 1.48, 95% CI 0.87 to 2.50); health-related quality of life (as measured by the Dermatology Life Quality Index (DLQI); a higher score indicates greater impairment; 127 participants; mean difference (MD) -4.20, 95% CI -11.68 to 3.28); and sleep disturbances (people with insomnia measured by the Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ-I), a dichotomous measure; 128 participants; RR 0.49, 95% CI 0.24 to 1.01). Participants who received serlopitant 1 mg may have a greater rate of relief of patient-reported pruritus intensity as measured by VAS compared to placebo; however, the 95% CI indicates that there may also be little to no difference between groups (126 participants; RR 1.50, 95% CI 0.89 to 2.54; low-certainty evidence). We are uncertain of the effects of serlopitant 1 mg compared to placebo on the following outcomes due to very low-certainty evidence: adverse events (128 participants; RR 1.45, 95% CI 0.86 to 2.47); health-related quality of life (DLQI; 128 participants; MD -6.90, 95% CI -14.38 to 0.58); and sleep disturbances (PSSQ-I; 128 participants; RR 0.38, 95% CI 0.17 to 0.84). Participants who received serlopitant 0.25 mg may have a greater rate of relief of patient-reported pruritus intensity as measured by VAS compared to placebo; however, the 95% CI indicates that there may also be little to no difference between groups (127 participants; RR 1.66, 95% CI 1.00 to 2.77; low-certainty evidence). We are uncertain of the effects of serlopitant 0.25 mg compared to placebo on the following outcomes due to very low-certainty evidence: adverse events (127 participants; RR 1.29, 95% CI 0.75 to 2.24); health-related quality of life (DLQI; 127 participants; MD -5.70, 95% CI -13.18 to 1.78); and sleep disturbances (PSSQ-I; 127 participants; RR 0.60, 95% CI 0.31 to 1.17). The most commonly reported adverse events were somnolence, diarrhoea, headache, and nasopharyngitis, among others. Our included study did not measure depression or patient satisfaction. We downgraded the certainty of evidence for all outcomes due to indirectness (only 55% of study participants had CPUO) and imprecision. We downgraded outcomes other than patient-reported pruritus intensity a further level due to concerns regarding risk of bias in selection of the reported result and some concerns with risk of bias due to missing outcome data (sleep disturbances only). We deemed risk of bias to be generally low.
AUTHORS' CONCLUSIONS


We found lack of evidence to address our review question: for most of our interventions of interest, we found no eligible studies. The neurokinin 1 receptor (NK1R) antagonist serlopitant was the only intervention that we could assess. One study provided low-certainty evidence suggesting that serlopitant may reduce pruritus intensity when compared with placebo. We are uncertain of the effects of serlopitant on other outcomes, as certainty of the evidence is very low. More studies with larger sample sizes, focused on patients with CPUO, are needed. Healthcare professionals, patients, and other stakeholders may have to rely on indirect evidence related to other forms of chronic pruritus when deciding between the main interventions currently used for this condition.",2020,"The most commonly reported adverse events were somnolence, diarrhoea, headache, and nasopharyngitis, among others.","['children and adults', '257 randomised (253 analysed) participants, aged 18 to 65 years; 60.6% were female', 'adults and children', 'participants with CPUO', 'severe chronic pruritus; 25 US centres participated (clinical research centres and universities']","['CPUO', 'pharmacological or topical or systemic pharmacological interventions', 'oral serlopitant', 'placebo', 'placebo, sham procedures, or no treatment or equivalent (e.g. waiting list']","['visual analogue scale (VAS; a reduction in VAS score', 'somnolence, diarrhoea, headache, and nasopharyngitis', 'safety and efficacy', ""Patient- or parent-reported pruritus intensity' and 'Adverse events"", 'rate of relief of patient-reported pruritus intensity', 'Dermatology Life Quality Index (DLQI', 'sleep disturbances (people with insomnia measured by the Pittsburgh Sleep Symptom Questionnaire-Insomnia', ""Health-related quality of life', 'Sleep disturbances', 'Depression', and 'Patient satisfaction"", 'sleep disturbances', 'dermatological diagnosis (atopic dermatitis/eczema', 'health-related quality of life', 'pruritus intensity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2825662', 'cui_str': 'serlopitant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0011625', 'cui_str': 'Agent, Dermatological'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}]",1.0,0.529225,"The most commonly reported adverse events were somnolence, diarrhoea, headache, and nasopharyngitis, among others.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Andrade', 'Affiliation': 'Hospital Italiano de Buenos Aires, Department of Dermatology, Tte. Peron 4230, Buenos Aires, Argentina, 1199.'}, {'ForeName': 'Chii Yang', 'Initials': 'CY', 'LastName': 'Kuah', 'Affiliation': ""King's College Hospital NHS Foundation Trust, Denmark Hill, London, UK, SE5 9RS.""}, {'ForeName': 'Juliana Esther', 'Initials': 'JE', 'LastName': 'Martin-Lopez', 'Affiliation': 'Andalusian Public Foundation for Progress and Health, Department of Research for Health Technology Assessment Service, Seville, Spain.'}, {'ForeName': 'Shunjie', 'Initials': 'S', 'LastName': 'Chua', 'Affiliation': 'urong East St21 Blk288A #03-358, Singapore, Singapore, 601288.'}, {'ForeName': 'Volha', 'Initials': 'V', 'LastName': 'Shpadaruk', 'Affiliation': 'University Hospitals of Leicester, Department of Dermatology, Leicester Royal Infirmary, OPD3 Balmoral Building, Leicester, UK, LE1 5WW.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Sanclemente', 'Affiliation': 'Universidad de Antioquia, Grupo de Investigación Dermatológica (GRID), Carrera 25 A #1 A Sur 45, Of 2026, Torre Medica El Tesoro, Medellín, Colombia.'}, {'ForeName': 'Juan Va', 'Initials': 'JV', 'LastName': 'Franco', 'Affiliation': 'Instituto Universitario Hospital Italiano, Argentine Cochrane Centre, Potosi 4234, Buenos Aires, Buenos Aires, Argentina, C1199ACL.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013128.pub2']
978,32106240,"Impact of a teacher-led school handwashing program on children's handwashing with soap at school and home in Bihar, India.","Handwashing with soap is an important preventive health behavior, and yet promoting this behavior has proven challenging. We report the results of a program that trained teachers to deliver a handwashing with soap behavior change program to children in primary schools in Bihar, India. Ten intervention schools selected along with ten nearby control schools, and intervention schools received the ""School of Five"" program promoting handwashing with soap using interactive stories, games, and songs, behavioral diaries to encourage habit formation, and public commitment. Households with children aged 8-13 attending the nearby school were enrolled in the study. Handwashing with soap was measured using sticker diaries before eating and after defecation 4 weeks after the intervention was completed. Children in the treatment reported 15.1% more handwashing with soap on key occasions (35.2%) than those in the control group (20.1%) (RR: 1.77, CI: (1.22, 2.58), p = .003). There was no evidence that handwashing with soap after defecation was higher in the treatment group than the control group (RR: 1.18, CI: (0.88, 1.57), p = .265), but there was strong evidence that handwashing with soap was greater in the treatment than in the control before eating (RR: 2.68, 95% CI: (1.43, 5.03), p = .002). Rates of handwashing increased both at home (RR: 1.63, CI: 1.14, 2.32), p = .007) and at school (RR: 4.76, 95% CI: (1.65, 17.9), p = .004), though the impact on handwashing with soap at key occasions in schools was much higher than at home. Promoting handwashing with soap through teachers in schools may be an effective way to achieve behavior change at scale.",2020,"There was no evidence that handwashing with soap after defecation was higher in the treatment group than the control group (RR: 1.18, CI: (0.88, 1.57), p = .265), but there was strong evidence that handwashing with soap was greater in the treatment than in the control before eating (RR:","['to children in primary schools in Bihar, India', ""children's handwashing with soap at school and home in Bihar, India"", 'Households with children aged 8-13 attending the nearby school were enrolled in the study', 'Ten intervention schools selected along with ten nearby control schools, and intervention schools received the']","['School of Five"" program promoting handwashing with soap using interactive stories, games, and songs, behavioral diaries to encourage habit formation, and public commitment', 'handwashing with soap behavior change program', 'teacher-led school handwashing program']","['Rates of handwashing', 'handwashing with soap on key occasions', 'handwashing with soap after defecation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0872005', 'cui_str': 'Songs'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",,0.0230905,"There was no evidence that handwashing with soap after defecation was higher in the treatment group than the control group (RR: 1.18, CI: (0.88, 1.57), p = .265), but there was strong evidence that handwashing with soap was greater in the treatment than in the control before eating (RR:","[{'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Tidwell', 'Affiliation': 'Mossavar-Rahmani Center for Business and Government, Harvard Kennedy School of Government, Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Anila', 'Initials': 'A', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Unilever PLC, London, United Kingdom.'}, {'ForeName': 'Arathi', 'Initials': 'A', 'LastName': 'Unni', 'Affiliation': 'Unilever PLC, London, United Kingdom.'}, {'ForeName': 'Esha', 'Initials': 'E', 'LastName': 'Sheth', 'Affiliation': 'Unilever PLC, London, United Kingdom.'}, {'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Daryanani', 'Affiliation': 'Unilever PLC, London, United Kingdom.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Population Services International, Delhi, India.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Sidibe', 'Affiliation': 'Mossavar-Rahmani Center for Business and Government, Harvard Kennedy School of Government, Cambridge, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0229655']
979,32091536,Association of Black Race With Early Recurrence After Minor Ischemic Stroke or Transient Ischemic Attack: Secondary Analysis of the POINT Randomized Clinical Trial.,"Importance


Stroke incidence is higher among black than white individuals in the United States. It is unclear whether black individuals have a higher risk of stroke recurrence after a minor ischemic stroke or transient ischemic attack (TIA), a high-risk setting in which focused preventive efforts can be effective.
Objective


To examine the association between black race and early ischemic stroke recurrence.
Design, Setting, and Participants


This cohort study analyzed data from the Platelet Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial conducted at 269 sites from May 28, 2010, to December 19, 2017. The trial enrolled 4881 adults within 12 hours of onset of a minor ischemic stroke (National Institutes of Health Stroke Scale score, 0-3) or high-risk TIA (ABCD2 score, ≥4). For this analysis, we excluded 598 patients enrolled outside the United States and 239 US patients with missing race/ethnicity data.
Main Outcomes and Measures


The primary outcome for this analysis was ischemic stroke within 90 days after randomization. Covariates included age, sex, Hispanic ethnicity, study assignment to take clopidogrel vs placebo, index stroke vs TIA, vascular risk factors, statin use, study drug adherence, and index event etiological subtype.
Results


Among 4044 patients included in the analysis, 918 (22.7%) were black. In an adjusted Cox model, black race was associated with a higher risk of recurrence compared with white race (hazard ratio, 1.6; 95% CI, 1.1-2.3). Findings were similar in subgroup analyses and in analyses limited to sites that enrolled black patients.
Conclusions and Relevance


Among US participants in the POINT trial, black individuals faced a higher risk of early stroke recurrence after a minor ischemic stroke or TIA. Our findings support research into black-white racial differences in the underlying mechanisms of recurrent stroke. In the meantime, extra effort should be made to ensure that black patients have access to proven secondary prevention measures.
Trial Registration


clinicaltrials.gov Identifier: NCT00991029.",2020,"In an adjusted Cox model, black race was associated with a higher risk of recurrence compared with white race (hazard ratio, 1.6; 95% CI, 1.1-2.3).","['4044 patients included in the analysis, 918 (22.7%) were black', '598 patients enrolled outside the United States and 239 US patients with missing race/ethnicity data', 'Participants\n\n\nThis cohort study analyzed data from the Platelet Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial conducted at 269 sites from May 28, 2010, to December 19, 2017', '4881 adults within 12 hours of onset of a minor ischemic stroke (National Institutes of Health Stroke Scale score, 0-3) or high-risk TIA (ABCD2 score, ≥4']",['clopidogrel vs placebo'],"['risk of early stroke recurrence', 'ischemic stroke', 'Black Race']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}]",4881.0,0.352948,"In an adjusted Cox model, black race was associated with a higher risk of recurrence compared with white race (hazard ratio, 1.6; 95% CI, 1.1-2.3).","[{'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Kamel', 'Affiliation': 'Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute and Department of Neurology, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Cenai', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute and Department of Neurology, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Dawn O', 'Initials': 'DO', 'LastName': 'Kleindorfer', 'Affiliation': 'Department of Neurology, University of Cincinnati, Ohio.'}, {'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Levitan', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Virginia J', 'Initials': 'VJ', 'LastName': 'Howard', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Howard', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Elsayed Z', 'Initials': 'EZ', 'LastName': 'Soliman', 'Affiliation': 'Epidemiological Cardiology Research Center, Division of Cardiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dell Medical School, Dean's Office, University of Texas at Austin, Austin.""}]",JAMA neurology,['10.1001/jamaneurol.2020.0010']
980,31154309,Replacing meat with alternative plant-based products (RE-MAPs): protocol for a randomised controlled trial of a behavioural intervention to reduce meat consumption.,"INTRODUCTION


Reducing meat consumption could contribute towards preventing some chronic conditions and protecting the natural environment. This study will examine the effectiveness of a behavioural intervention to reduce meat consumption.
METHODS AND ANALYSES


Replacing meat with alternative plant-based product is a randomised controlled trial comparing a behavioural intervention to reduce meat consumption with a no intervention control condition. Eligible volunteers will be recruited from the general public through advertisement and randomised in a 1:1 ratio to receive no intervention or a 4-week intervention comprising the provision of free plant-based meat alternatives, written information on the health and environmental benefits of eating less meat, success stories of people who reduced their meat consumption and recipes. The primary outcome is the change in meat consumption at 4 weeks (T1) from baseline. Secondary and exploratory outcomes include changes in meat consumption at 8 weeks (T2) from baseline and changes from the baseline to both follow-up in other aspects of participants diet, putative psychosocial determinants of eating a low meat diet and of using meat substitutes and biomarkers of health risk, including blood lipid profiles, blood pressure, weight and body composition. Linear models will be employed to explore whether the changes in each of the aforementioned outcomes differ significantly between the control and intervention group. Qualitative interviews on a subsample of participants receiving the intervention will evaluate their experiences of the intervention and help to identify the mechanisms through which the intervention reduced meat consumption or the barriers preventing the intervention to aid this dietary transition.
ETHICS AND DISSEMINATION


The trial has been granted ethical approval by the Medical Sciences Interdivisional Research Ethics Committee (IDREC) of the University of Oxford (Ref: R54329/RE001). All results originating from this study will be submitted for publication in scientific journals and presented at meetings and through the media.
TRIAL REGISTRATION NUMBER


ISRCTN13180635;Pre-recruitment.",2019,Linear models will be employed to explore whether the changes in each of the aforementioned outcomes differ significantly between the control and intervention group.,['Eligible volunteers will be recruited from the general public through advertisement and randomised in a 1:1 ratio to receive'],"['Replacing meat with alternative plant-based products (RE-MAPs): protocol', 'no intervention or a 4-week intervention comprising the provision of free plant-based meat alternatives, written information on the health and environmental benefits of eating less meat, success stories of people who reduced their meat consumption and recipes', 'behavioural intervention', 'behavioural intervention to reduce meat consumption with a no intervention control condition']","['meat consumption', 'changes in meat consumption at 8\u2009weeks (T2) from baseline and changes from the baseline to both follow-up in other aspects of participants diet, putative psychosocial determinants of eating a low meat diet and of using meat substitutes and biomarkers of health risk, including blood lipid profiles, blood pressure, weight and body composition', 'change in meat consumption']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",,0.064339,Linear models will be employed to explore whether the changes in each of the aforementioned outcomes differ significantly between the control and intervention group.,"[{'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Bianchi', 'Affiliation': 'Nuffield Department of Primary Care Health Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nerys M', 'Initials': 'NM', 'LastName': 'Astbury', 'Affiliation': 'Nuffield Department of Primary Care Health Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Cook', 'Affiliation': 'Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Cartwright', 'Affiliation': 'Lee Kong Chain medical school, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Primary Care Health Sciences, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2018-027016']
981,32100681,"Effect of Improved Water Quality, Sanitation, Hygiene and Nutrition Interventions on Respiratory Illness in Young Children in Rural Bangladesh: A Multi-Arm Cluster-Randomized Controlled Trial.","Acute respiratory infections cause mortality in young children. We assessed the effects of water, sanitation, hygiene (WASH) and nutritional interventions on childhood ARI. Geographic clusters of pregnant women from rural Bangladesh were randomly assigned to receive 1) chlorinated drinking water and safe storage (W); 2) upgraded sanitation (S); 3) handwashing promotion (H); 4) combined water, sanitation, and handwashing (WSH); 5) nutrition intervention including lipid-based nutrient supplements; 6) combined WSH plus nutrition (WSHN); or 7) no intervention (control). Masking of participants was not possible. Acute respiratory illness was defined as caregiver-reported persistent cough, panting, wheezing, or difficulty breathing in the past 7 days among index children, those born to enrolled women. We assessed outcomes at 12 and 24 months of intervention using intention to treat. Compared with children in the control group (ARI prevalence,  P : 8.9%), caregivers of index children reported significantly lower ARI in the water ( P : 6.3%, prevalence ratio (PR): 0.71; 95% CI: 0.53, 0.96), sanitation ( P : 6.4%, PR: 0.75, 95% CI: 0.58, 0.96), handwashing ( P : 6.4%, PR: 0.68, 95% CI: 0.50, 0.93), and the combined WSH+N arms ( P : 5.9%, PR: 0.67, 95% CI: 0.50, 0.90). Those in the nutrition ( P : 7.4%, PR: 0.84, 95% CI: 0.63, 1.10) or the WSH arm ( P : 8.9%, PR: 0.99, 95% CI: 0.76, 1.28) reported similar ARI prevalence compared with control children. Single targeted water, sanitation, and hygiene interventions reduced reported respiratory illness in young children. There was no apparent respiratory health benefit from combining WASH interventions.",2020,"Those in the nutrition ( P : 7.4%, PR: 0.84, 95% CI: 0.63, 1.10) or the WSH arm ( P : 8.9%, PR: 0.99, 95% CI: 0.76, 1.28) reported similar ARI prevalence compared with control children.","['young children', 'Geographic clusters of pregnant women from rural Bangladesh', 'childhood ARI', 'Young Children in Rural Bangladesh']","['water, sanitation, hygiene (WASH) and nutritional interventions', 'Water Quality, Sanitation, Hygiene and Nutrition Interventions', '1) chlorinated drinking water and safe storage (W); 2) upgraded sanitation (S); 3) handwashing promotion (H); 4) combined water, sanitation, and handwashing (WSH); 5) nutrition intervention including lipid-based nutrient supplements; 6) combined WSH plus nutrition (WSHN); or 7) no intervention (control']","['ARI prevalence', 'Respiratory Illness', 'respiratory illness', 'Acute respiratory infection', 'ARI']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0597680', 'cui_str': 'Water Quality'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0339901', 'cui_str': 'ARI - Acute respiratory infections'}]",,0.134988,"Those in the nutrition ( P : 7.4%, PR: 0.84, 95% CI: 0.63, 1.10) or the WSH arm ( P : 8.9%, PR: 0.99, 95% CI: 0.76, 1.28) reported similar ARI prevalence compared with control children.","[{'ForeName': 'Sania', 'Initials': 'S', 'LastName': 'Ashraf', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mahfuza', 'Initials': 'M', 'LastName': 'Islam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Unicomb', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mahbubur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Winch', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Benjamin-Chung', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California.'}, {'ForeName': 'Pavani K', 'Initials': 'PK', 'LastName': 'Ram', 'Affiliation': 'School of Public Health and Health Professions, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Colford', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0769']
982,31856964,Long-Term Follow-Up of Complete Versus Lesion-Only Revascularization in STEMI and Multivessel Disease: The CvLPRIT Trial.,"BACKGROUND


Randomized trials have shown that complete revascularization in patients with ST-segment elevation myocardial infarction (MI) with multivessel disease results in lower major adverse cardiovascular events (MACE) (all-cause death, MI, ischemia-driven revascularization, heart failure).
OBJECTIVES


The goal of this study was to determine whether the benefits of complete revascularization are sustained long-term and their impact on hard endpoints.
METHODS


CvLPRIT (Complete versus Lesion-only Primary PCI Trial) was a randomized trial of complete inpatient revascularization versus infarct-related artery revascularization only at the index admission. Randomized patients have been followed longer-term. The components of the original primary endpoint were collected from physical and electronic patient records, and from local databases for all readmissions.
RESULTS


The median follow-up (achieved in >90% patients) from randomization to first event or last follow-up was 5.6 years (0.0 to 7.3 years). The primary MACE endpoint rate at this time point was 24.0% in the complete revascularization group but 37.7% of the infarct-related artery-only group (hazard ratio: 0.57; 95% confidence interval: 0.37 to 0.87; p = 0.0079). The composite endpoint of all-cause death/MI was 10.0% in the complete revascularization group versus 18.5% in the infarct-related artery-only group (hazard ratio: 0.47; 95% confidence interval: 0.25 to 0.89; p = 0.0175). In a landmark analysis (from 12 months to final follow-up), there was no significant difference between MACE, death/MI, and individual components of the primary endpoint.
CONCLUSIONS


Long-term follow-up of the CvLPRIT trial shows that the significantly lower rate of MACE in the complete revascularization group, previously seen at 12 months, is sustained to a median of 5.6 years. A significant difference in composite all-cause death/MI favoring the complete revascularization was also observed. (Complete versus Lesion-only Primary PCI Trial; ISRCTN70913605).",2019,The primary MACE endpoint rate at this time point was 24.0% in the complete revascularization group but 37.7% of the infarct-related artery-only group (hazard ratio: 0.57; 95% confidence interval: 0.37 to 0.87; p = 0.0079).,"['patients with ST-segment elevation myocardial infarction (MI) with multivessel disease', 'STEMI\xa0and\xa0Multivessel Disease']",['complete inpatient revascularization versus infarct-related artery revascularization'],"['composite endpoint of all-cause death/MI', 'primary MACE endpoint rate at this time point', 'MACE, death/MI, and individual components of the primary endpoint', 'rate of MACE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",,0.161306,The primary MACE endpoint rate at this time point was 24.0% in the complete revascularization group but 37.7% of the infarct-related artery-only group (hazard ratio: 0.57; 95% confidence interval: 0.37 to 0.87; p = 0.0079).,"[{'ForeName': 'Anthony H', 'Initials': 'AH', 'LastName': 'Gershlick', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and Cardiovascular Theme, NIHR Leicester Biomedical Research Centre, Glenfield Hospital, Leicester, United Kingdom. Electronic address: agershlick@aol.com.'}, {'ForeName': 'Amerjeet S', 'Initials': 'AS', 'LastName': 'Banning', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and Cardiovascular Theme, NIHR Leicester Biomedical Research Centre, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Parker', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and Cardiovascular Theme, NIHR Leicester Biomedical Research Centre, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Charley A', 'Initials': 'CA', 'LastName': 'Budgeon', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and Cardiovascular Theme, NIHR Leicester Biomedical Research Centre, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Damian J', 'Initials': 'DJ', 'LastName': 'Kelly', 'Affiliation': 'Department of Cardiology, Royal Derby Hospital, Derby, United Kingdom.'}, {'ForeName': 'Peter O', 'Initials': 'PO', 'LastName': 'Kane', 'Affiliation': 'Department of Cardiology, Royal Bournemouth and Christchurch Hospitals, Bournemouth, United Kingdom.'}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Dalby', 'Affiliation': 'Department of Cardiology, Royal Brompton & Harefield NHS Foundation Trust, Harefield Hospital, Middlesex, London, United Kingdom.'}, {'ForeName': 'Simon L', 'Initials': 'SL', 'LastName': 'Hetherington', 'Affiliation': 'Department of Cardiology, Kettering General Hospital, Rothwell Road, Kettering, United Kingdom.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and Cardiovascular Theme, NIHR Leicester Biomedical Research Centre, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre & The Division of Biomedical Imaging, Leeds Institute of Cardiovascular & Metabolic Medicine, Leeds University, Leeds, United Kingdom.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Curzen', 'Affiliation': 'Department of Cardiology, University Hospital Southampton, and University of Southampton, Southampton, United Kingdom.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.10.033']
983,31326480,Randomized Comparison of Clinical Effectiveness of Pharmacologic SPECT and PET MPI in Symptomatic CAD Patients.,"OBJECTIVES


This study compared the clinical effectiveness of pharmacologic stress myocardial perfusion imaging (MPI) plus positron emission tomography (PET) with single-photon emission computed tomography (SPECT) in patients with known coronary artery disease (CAD) presenting with symptoms suggestive of ischemia.
BACKGROUND


Although PET MPI has been shown to have higher diagnostic accuracy in detecting hemodynamically significant CAD than SPECT MPI, whether this impacts downstream management has not been formally evaluated in randomized trials.
METHODS


This study consisted of a single-center trial in which patients with known CAD and suspected ischemia were randomized to undergo PET or attenuation-corrected SPECT MPI between June 2009 and September 2013. Post-test management was at the discretion of the referring physician, and patients were followed for 12 months. The primary endpoint was diagnostic failure, defined as unnecessary angiography (absence of ≥50% stenosis in ≥1 vessel) or additional noninvasive testing within 60 days of the MPI. Secondary endpoints were post-test escalation of antianginal therapy, referral for angiography, coronary revascularization, and health status at 3, 6, and 12 months.
RESULTS


A total of 322 patients with an evaluable MPI were randomized (n = 161 in each group). At baseline, 88.8% of patients were receiving aspirin therapy, 76.7% were taking beta-blockers, and 77.3% were taking statin therapy. Diagnostic failure within 60 days occurred in only 7 patients (2.2%) (3 [1.9%] in the PET group and 4 [2.5%] in the SPECT group; p = 0.70). There were no significant differences between the 2 groups in subsequent rates of coronary angiography, coronary revascularization, or health status at 3, 6, and 12 months of follow-up (all p values ≥0.20); however, when subjects were stratified by findings on MPI in a post hoc analysis, those with high-risk MPI on PET testing had higher rates of angiography and revascularization on follow-up than those who had SPECT MPI, whereas those undergoing low-risk PET studies had lower rates of both procedures than those undergoing SPECT (interaction between randomized modality ∗high-risk MPI for 12-month catheterization [p = 0.001] and 12-month revascularization [p = 0.09]).
CONCLUSIONS


In this contemporary cohort of symptomatic CAD patients who were optimally medically managed, there were no discernible differences in rates of diagnostic failure at 60 days, subsequent coronary angiography, revascularization, or patient health status at 1 year between patients evaluated by pharmacologic PET compared with those evaluated by SPECT MPI. Downstream invasive testing rates with PET MPI were more consistent with high-risk features than those with SPECT MPI. (Effectiveness Study of Single Photon Emission Computed Tomography [SPECT] Versus Positron Emission Tomography [PET] Myocardial Perfusion Imaging; NCT00976053).",2019,"There were no significant differences between the 2 groups in subsequent rates of coronary angiography, coronary revascularization, or health status at 3, 6, and 12 months of follow-up (all p values ≥0.20); however when subjects were stratified by findings on MPI in a post hoc analysis, those with high-risk MPI on PET testing had higher rates of angiography and revascularization on follow-up than those who had SPECT MPI, whereas those undergoing low-risk PET studies had lower rates of both procedures than those undergoing SPECT (interaction between randomized modality ∗high-risk MPI for 12-month catheterization [p = 0.001] and 12-month revascularization [p = 0.09]).
","['Symptomatic CAD Patients', 'patients with known coronary artery disease (CAD) presenting with symptoms suggestive of ischemia', '322 patients with an evaluable MPI', 'patients with known CAD and suspected ischemia']","['aspirin therapy', 'PET or attenuation-corrected SPECT MPI', 'Single Photon Emission Computed Tomography [SPECT', 'pharmacologic stress myocardial perfusion imaging (MPI) plus positron emission tomography (PET) with single-photon emission computed tomography (SPECT', 'Pharmacologic SPECT and PET MPI']","['subsequent rates of coronary angiography, coronary revascularization, or health status', 'rates of angiography and revascularization', 'diagnostic failure, defined as unnecessary angiography (absence of', 'Diagnostic failure', 'rates of diagnostic failure', 'post-test escalation of antianginal therapy, referral for angiography, coronary revascularization, and health status at 3, 6, and 12\xa0months', 'subsequent coronary angiography, revascularization, or patient health status']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of (attribute)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}]","[{'cui': 'C4303556', 'cui_str': 'Aspirin therapy'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0040399', 'cui_str': 'SPECT'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2350390', 'cui_str': 'Myocardial Perfusion Imaging'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}]","[{'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0585942', 'cui_str': 'Antianginal therapy (procedure)'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",322.0,0.14538,"There were no significant differences between the 2 groups in subsequent rates of coronary angiography, coronary revascularization, or health status at 3, 6, and 12 months of follow-up (all p values ≥0.20); however when subjects were stratified by findings on MPI in a post hoc analysis, those with high-risk MPI on PET testing had higher rates of angiography and revascularization on follow-up than those who had SPECT MPI, whereas those undergoing low-risk PET studies had lower rates of both procedures than those undergoing SPECT (interaction between randomized modality ∗high-risk MPI for 12-month catheterization [p = 0.001] and 12-month revascularization [p = 0.09]).
","[{'ForeName': 'Krishna K', 'Initials': 'KK', 'LastName': 'Patel', 'Affiliation': ""Department of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri; Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri. Electronic address: patelkris@umkc.edu.""}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Al Badarin', 'Affiliation': ""Department of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri; Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Chan', 'Affiliation': ""Department of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri; Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Department of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri; Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'Staci', 'Initials': 'S', 'LastName': 'Courter', 'Affiliation': 'Cardiovascular Imaging Technologies, Kansas City, Missouri.'}, {'ForeName': 'Kevin F', 'Initials': 'KF', 'LastName': 'Kennedy', 'Affiliation': ""Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Case', 'Affiliation': 'Cardiovascular Imaging Technologies, Kansas City, Missouri.'}, {'ForeName': 'A Iain', 'Initials': 'AI', 'LastName': 'McGhie', 'Affiliation': ""Department of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri; Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'Gary V', 'Initials': 'GV', 'LastName': 'Heller', 'Affiliation': 'Department of Cardiology, Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Bateman', 'Affiliation': ""Department of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri; Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri.""}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2019.04.020']
984,31699704,Effects of One Year of Vitamin D and Marine Omega-3 Fatty Acid Supplementation on Biomarkers of Systemic Inflammation in Older US Adults.,"BACKGROUND


Observational studies suggest vitamin D and marine ω-3 fatty acid (n-3 FA) supplements are associated with lower systemic inflammation. However, past trials have been inconsistent.
METHODS


The randomized, double-blind, placebo-controlled VITamin D and OmegA-3 TriaL (VITAL) tested vitamin D (2000 IU/day) and/or n-3 FA (1 g/day) supplementation in a 2 × 2 factorial design among women ≥55 and men ≥50 years of age. We assessed changes in interleukin (IL)-6, tumor necrosis factor receptor 2 (TNFR2), and high-sensitivity C-reactive protein (hsCRP) concentrations from baseline to 1 year among participants randomized to vitamin D + n-3 FA (392), vitamin D (392), n-3 FA (392), or placebo only (385). Geometric means and percent changes were compared, adjusting for baseline factors.
RESULTS


Baseline characteristics were well balanced. In the active arms, 25-OH vitamin D rose 39% and n-3 FA rose 55% vs minimal change in placebo arms. Neither supplement reduced biomarkers at 1 year. Vitamin D resulted in 8.2% higher IL-6 (95% CI, 1.5%-15.3%; adjusted  P  = 0.02), but TNFR2 and hsCRP did not. Among 784 receiving vitamin D, hsCRP increased 35.7% (7.8%-70.9%) in those with low (<20 ng/mL) but not with higher baseline serum 25(OH) vitamin D [0.45% (-8.9% to 10.8%);  P  interaction = 0.02]. Among 777 randomized to n-3 FA, hsCRP declined [-10.5% (-20.4% to 0.8%)] in those with baseline low (<1.5 servings/week), but not with higher fish intake [6.4% (95% CI, -7.11% to 21.8%);  P  interaction = 0.06].
CONCLUSIONS


In this large sample from a population-based randomized controlled trial, neither vitamin D nor n-3 FA supplementation over 1 year decreased these biomarkers of inflammation.
CLINICALTRIALSGOV IDENTIFIER


NCT01169259; NCT01351805.",2019,Vitamin D resulted in 8.2% higher IL-6,"['women ≥55 and men ≥50 years of age', 'Older US Adults']","['placebo-controlled VITamin D and OmegA-3 TriaL', 'Vitamin D and Marine Omega-3 Fatty Acid Supplementation', 'and/or n-3 FA', 'vitamin D, hsCRP', 'vitamin D nor n-3 FA supplementation', 'vitamin D + n-3 FA (392), vitamin D (392), n-3 FA (392), or placebo', 'n-3 FA', 'vitamin D and marine ω-3 fatty acid (n-3 FA) supplements', 'vitamin D', 'Vitamin D']","['baseline serum 25(OH) vitamin D', 'IL-6', 'interleukin (IL)-6, tumor necrosis factor receptor 2 (TNFR2), and high-sensitivity C-reactive protein (hsCRP) concentrations']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0255813', 'cui_str': 'Receptors, Tumor Necrosis Factor, Type II'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",777.0,0.792985,Vitamin D resulted in 8.2% higher IL-6,"[{'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Costenbader', 'Affiliation': 'Division of Rheumatology, Inflammation and Immunity, and kcostenbader@bwh.harvard.edu.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'MacFarlane', 'Affiliation': 'Division of Rheumatology, Inflammation and Immunity, and.'}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kotler', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}]",Clinical chemistry,['10.1373/clinchem.2019.306902']
985,31699734,Can implementation failure or intervention failure explain the result of the 3D multimorbidity trial in general practice: mixed-methods process evaluation.,"OBJECTIVES


During a cluster randomised trial, (the 3D study) of an intervention enacting recommended care for people with multimorbidity, including continuity of care and comprehensive biennial reviews, we examined implementation fidelity to interpret the trial outcome and inform future implementation decisions.
DESIGN


Mixed-methods process evaluation using cross-trial data and a sample of practices, clinicians, administrators and patients. Interviews, focus groups and review observations were analysed thematically and integrated with quantitative data about implementation. Analysis was blind to trial outcomes and examined context, intervention adoption, reach and maintenance, and delivery of reviews to patients.
SETTING


Thirty-three UK general practices in three areas.
PARTICIPANTS


The trial included 1546 people with multimorbidity. 11 general practitioners, 14 nurses, 7 administrators and 38 patients from 9 of 16 intervention practices were sampled for an interview.
RESULTS


Staff loss, practice size and different administrative strategies influenced implementation fidelity. Practices with whole administrative team involvement and good alignment between the intervention and usual care generally implemented better. Fewer reviews than intended were delivered (49% of patients receiving both intended reviews, 30% partially reviewed). In completed reviews >90% of intended components were delivered, but review observations and interviews with patients and clinicians found variation in style of component delivery, from 'tick-box' to patient-centred approaches. Implementation barriers included inadequate skills training to implement patient-centred care planning, but patients reported increased patient-centredness due to comprehensive reviews, extra time and being asked about their health concerns.
CONCLUSIONS


Implementation failure contributed to lack of impact of the 3D intervention on the trial primary outcome (quality of life), but so did intervention failure since modifiable elements of intervention design were partially responsible. When a decisive distinction between implementation failure and intervention failure cannot be made, identifying potentially modifiable reasons for suboptimal implementation is important to enhance potential for impact and effectiveness of a redesigned intervention.
TRIAL REGISTRATION NUMBER


ISRCTN06180958.",2019,"Implementation barriers included inadequate skills training to implement patient-centred care planning, but patients reported increased patient-centredness due to comprehensive reviews, extra time and being asked about their health concerns.
","['Thirty-three UK general practices in three areas', '1546 people with multimorbidity', 'people with multimorbidity, including continuity of care and comprehensive biennial reviews', '11 general practitioners, 14 nurses, 7 administrators and 38 patients from 9 of 16 intervention practices were sampled for an interview']",['inadequate skills training to implement patient-centred care planning'],[],"[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0085751', 'cui_str': 'Administrators'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]",[],1546.0,0.1225,"Implementation barriers included inadequate skills training to implement patient-centred care planning, but patients reported increased patient-centredness due to comprehensive reviews, extra time and being asked about their health concerns.
","[{'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Mann', 'Affiliation': 'Centre for Academic Primary Care, School of Population Health Sciences, University of Bristol, Bristol, UK cindy.mann@bristol.ac.uk.'}, {'ForeName': 'Ali R G', 'Initials': 'ARG', 'LastName': 'Shaw', 'Affiliation': 'Centre for Academic Primary Care, School of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Guthrie', 'Affiliation': 'Division of Population Health Sciences, University of Dundee, Dundee, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Wye', 'Affiliation': 'Centre for Academic Primary Care, School of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Mei-See', 'Initials': 'MS', 'LastName': 'Man', 'Affiliation': 'Centre for Academic Primary Care, School of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Chaplin', 'Affiliation': 'Centre for Academic Primary Care, School of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Salisbury', 'Affiliation': 'Centre for Academic Primary Care, School of Population Health Sciences, University of Bristol, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031438']
986,31655020,Impact of the addition of azithromycin to antimalarials used for seasonal malaria chemoprevention on antimicrobial resistance of Streptococcus pneumoniae.,"OBJECTIVE


A trial was conducted in Burkina Faso and Mali to investigate whether addition of azithromycin to the antimalarials used for seasonal malaria chemoprevention reduces mortality and hospital admissions of children. We tested the sensitivity of nasal isolates of Streptococcus pneumoniae obtained during this trial to azithromycin and other antibiotics.
METHODS


Azithromycin or placebo was administered monthly, in combination with the antimalarials used for seasonal malaria chemoprevention, for four months, over the annual malaria transmission seasons of 2014, 2015, and 2016. Nasopharyngeal swabs were collected from 2773 Burkinabe and 2709 Malian children on seven occasions: in July and December each year prior to and after drug administration, and at a final survey in early 2018. Pneumococci were isolated from nasopharyngeal swabs and tested for sensitivity to azithromycin and other antibiotics.
RESULTS


A total of 5482 samples were collected. In Burkina Faso, the percentage of pneumococcal isolates resistant to azithromycin among children who had received it increased from 4.9% (95% CI: 2.4%, 9.9%) before the intervention to 25.6% (95% CI: 17.6%, 35.7%) afterward. In Mali, the increase was from 7.6% (95% CI: 3.8%, 14.4%) to 68.5% (95% CI: 55.1%, 79.4%). The percentage of resistant isolates remained elevated (17.7% (95% CI: 11.1%, 27.1%) in Burkina Faso and 19.1% (95% CI: 13.5%, 26.3%) in Mali) among children who had received azithromycin 1 year after stopping the intervention. An increase in resistance to azithromycin was also observed in children who had received a placebo but it was less marked.
CONCLUSION


Addition of azithromycin to the antimalarial combination used for seasonal malaria chemoprevention was associated with an increase in resistance of pneumococci to azithromycin and erythromycin, which persisted 1 year after the last administration of azithromycin.",2019,"An increase in resistance to azithromycin was also observed in children who had received a placebo but it was less marked.
","['children', 'Nasopharyngeal swabs were collected from 2773 Burkinabe and 2709 Malian children on seven occasions: in July and December each year prior to and after drug administration, and at a final survey in early 2018']","['placebo', 'azithromycin', 'azithromycin and erythromycin', 'Azithromycin or placebo']","['resistance of pneumococci', 'percentage of resistant isolates', 'antimicrobial resistance of Streptococcus pneumoniae', 'resistance to azithromycin']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab (specimen)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]",,0.169842,"An increase in resistance to azithromycin was also observed in children who had received a placebo but it was less marked.
","[{'ForeName': 'Soumeya', 'Initials': 'S', 'LastName': 'Hema-Ouangraoua', 'Affiliation': 'Centre MURAZ, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Abdoul', 'Initials': 'A', 'LastName': 'Aziz Maiga', 'Affiliation': 'Centre pour le Développement des Vaccins du Mali, Bamako, Mali.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cairns', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Zongo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Nikiema', 'Initials': 'N', 'LastName': 'Frédéric', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Rakiswendé', 'Initials': 'R', 'LastName': 'Serge Yerbanga', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Boubou', 'Initials': 'B', 'LastName': 'Tamboura', 'Affiliation': 'Centre pour le Développement des Vaccins du Mali, Bamako, Mali.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Badji', 'Affiliation': 'Centre pour le Développement des Vaccins du Mali, Bamako, Mali.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Gore-Langton', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kuepfer', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Centre (MRTC), University of Science, Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Centre (MRTC), University of Science, Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Samba O', 'Initials': 'SO', 'LastName': 'Sow', 'Affiliation': 'Malaria Research and Training Centre (MRTC), University of Science, Techniques and Technologies of Bamako, Bamako, Mali.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandrahoman', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bosco Ouedraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13321']
987,31838258,Program to improve mobility in aging (PRIMA) study: Methods and rationale of a task-oriented motor learning exercise program.,"Walking difficulty is a common and costly problem in older adults. A potentially important yet unaddressed strategy to enhance walking ability through exercise intervention is to add a timing and coordination component in gait training (i.e. task specific timing and coordination exercise intervention) to the usual strength, endurance, and flexibility training. We describe the methods and rationale of a randomized single-blind, physical therapist supervised, exercise intervention trial to compare the effects of a standard strength, endurance, and flexibility program to a standard plus timing and coordination program in community-dwelling older adults walking slower than the desired gait speed of 1.2 m/s. Exercise sessions are twice weekly for 12 weeks. Participants are assessed at baseline, 12 weeks (post intervention), 24 weeks and 36 weeks. The primary outcome is gait speed, secondary outcomes represent components of the interventions (strength, endurance, flexibility, timing and coordination), and tertiary outcomes are measure of activity and participation (Late Life Function and Disability Instrument and physical activity). The findings of this trial will (1) establish if a standard-plus task specific timing and coordination program is superior to a standard strength and endurance program in improving mobility, activity and participation and (2) determine if the improvements are sustained over time. The information derived from this project will provide valuable insight into the prevention and management of walking difficulty, which is so common in older Americans.",2020,"The findings of this trial will (1) establish if a standard-plus task specific timing and coordination program is superior to a standard strength and endurance program in improving mobility, activity and participation and (2) determine if the improvements are sustained over time.","['older Americans', 'older adults', 'community-dwelling older adults walking slower than the desired gait speed of 1.2\u202fm/s']","['standard strength, endurance, and flexibility program to a standard plus timing and coordination program', 'task-oriented motor learning exercise program']","['gait speed, secondary outcomes represent components of the interventions (strength, endurance, flexibility, timing and coordination), and tertiary outcomes are measure of activity and participation (Late Life Function and Disability Instrument and physical activity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439493', 'cui_str': 'meter/second'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.040983,"The findings of this trial will (1) establish if a standard-plus task specific timing and coordination program is superior to a standard strength and endurance program in improving mobility, activity and participation and (2) determine if the improvements are sustained over time.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Brach', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, United States. Electronic address: jbrach@pitt.edu.'}, {'ForeName': 'Jessie M', 'Initials': 'JM', 'LastName': 'VanSwearingen', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Gil', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Neelesh K', 'Initials': 'NK', 'LastName': 'Nadkarni', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States; Department of Neurology, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kriska', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Rakie', 'Initials': 'R', 'LastName': 'Cham', 'Affiliation': 'Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States; Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105912']
988,32159243,Peer mentorship as an adjunct intervention for the treatment of eating disorders: A pilot randomized trial.,"OBJECTIVE


Peer mentorship has been shown to be helpful for other mental health conditions, but it has been understudied for patients with eating disorders. The goal of the present study was to evaluate the feasibility and efficacy of peer mentorship for individuals with eating disorders by conducting a randomized controlled trial (RCT).
TRIAL DESIGN


Parallel three-arm pilot RCT with 1:1:1 allocation to peer mentorship, social support mentorship (active comparison intervention), and waiting list.
METHOD


Sixty outpatients with anorexia nervosa (AN), bulimia nervosa (BN), or binge-eating disorder (BED) were randomly assigned to a condition. Outcome measures, including eating disorder symptoms and general psychopathology, were completed at baseline, mid-, and postintervention.
RESULTS


Session attendance and acceptability ratings were higher in peer mentorship than social support mentorship. More participants in social support mentorship (39%) dropped out compared to peer mentorship (5%). In intent-to-treat analysis, peer mentorship showed greater reductions in body dissatisfaction and anxiety compared with both control groups. Compared with social support mentorship, peer mentorship had greater reductions in depression. Compared with waiting list, peer mentorship had greater reduction in binge eating days/week in patients with BN/BED and restriction days/week in patients with AN. Peer mentorship did not impact body mass index or reentry into higher level of care.
DISCUSSION


This pilot RCT provides preliminary evidence that peer mentorship is effective for some cognitive and behavioral symptoms of eating disorders as an adjunct to outpatient treatment. Additional studies are needed to evaluate the efficacy of peer mentorship in absence of treatment.",2020,"Compared with waiting list, peer mentorship had greater reduction in binge eating days/week in patients with BN/BED and restriction days/week in patients with AN.","['eating disorders', 'patients with eating disorders', 'Sixty outpatients with anorexia nervosa (AN), bulimia nervosa (BN), or binge-eating disorder (BED', 'individuals with eating disorders']","['social support mentorship', 'peer mentorship, social support mentorship (active comparison intervention), and waiting list', 'peer mentorship', 'Peer mentorship', 'social support mentorship, peer mentorship']","['acceptability ratings', 'eating disorder symptoms and general psychopathology', 'body dissatisfaction and anxiety', 'binge eating days', 'feasibility and efficacy', 'depression']","[{'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C2267227', 'cui_str': 'Bulimia Nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0037438'}, {'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",60.0,0.0469861,"Compared with waiting list, peer mentorship had greater reduction in binge eating days/week in patients with BN/BED and restriction days/week in patients with AN.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Ranzenhofer', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Mylene', 'Initials': 'M', 'LastName': 'Wilhelmy', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Annabella', 'Initials': 'A', 'LastName': 'Hochschild', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Sanzone', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'B Timothy', 'Initials': 'BT', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Attia', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}]",The International journal of eating disorders,['10.1002/eat.23258']
989,32164439,"Prevalence, Symptom Burden and Under-Diagnosis of Chronic Obstructive Pulmonary Disease in a Lung Cancer Screening Cohort.","RATIONALE


Individuals eligible for lung cancer screening (LCS) by low-dose computed tomography (LDCT) are also at risk of Chronic Obstructive Pulmonary Disease (COPD) due to age and smoking exposure. Whether the LCS episode is useful for early detection of COPD is not well established.
OBJECTIVES


To explore associations between symptoms, comorbidities, spirometry and emphysema in participants enrolled in the Lung Screen Uptake Trial (LSUT).
METHODS


This cross-sectional study was a pre-specified analysis nested within LSUT, which was a randomized study testing the impact of differing invitation materials on attendance of 60-75 year-old smokers and ex-smokers to a 'lung health check' between November 2015 and July 2017. Participants with a smoking history ≥30 pack-years and quit ≤15 years ago, or meeting a lung cancer risk of ≥1.51% via the Prostate Lung Colorectal Ovarian (PLCOm2012) model or ≥2.5% via the Liverpool Lung Project (LLP) model, were offered LDCT. COPD was defined and classified according to the Global Initiative for Obstructive Lung Disease (GOLD) criteria using pre-bronchodilator spirometry. Analyses included the use of descriptive statistics, chi square tests to examine group differences, and univariable and multivariable logistic regression to explore associations between symptom prevalence, airflow limitation and visually graded emphysema.
RESULTS


560 of 986 individuals included in the analysis (57%) had pre-bronchodilator spirometry consistent with COPD. 67% did not have a prior history of COPD and were termed 'undiagnosed'. Emphysema prevalence in those with known and 'undiagnosed' COPD was 73% and 68% respectively. 32% of those with 'undiagnosed COPD' had no emphysema on LDCT. Inhaler use and symptoms were more common in the 'known' than the 'undiagnosed' COPD group (63% vs. 33% with persistent cough [p<0.001], 73% vs. 33% with dyspnoea [p<0.001]). Comorbidities were common in all groups. Adjusted odds of respiratory symptoms were more significant for airflow obstruction (aOR GOLD 1&2: 1.57, CI 1.14-2.17; aOR GOLD 3&4: 4.6, CI 2.17-9.77); than emphysema (aOR mild: 1.12, CI 0.81-1.55; aOR moderate: 1.33, CI 0.85-2.09; aOR severe: 4.00, CI 1.57-10.2).
CONCLUSIONS


There is high burden of 'undiagnosed COPD' and emphysema in LCS participants. Adding spirometry findings to the LDCT enhances identification of individuals with COPD. Clinical trial registered with ClinicalTrials.gov (NCT02558101).",2020,"Inhaler use and symptoms were more common in the 'known' than the 'undiagnosed' COPD group (63% vs. 33% with persistent cough [p<0.001], 73% vs. 33% with dyspnoea [p<0.001]).","['560 of 986 individuals included in the analysis (57%) had pre-bronchodilator spirometry consistent with COPD', 'Individuals eligible for lung cancer screening (LCS) by low-dose', ""60-75 year-old smokers and ex-smokers to a 'lung health check' between November 2015 and July 2017"", 'individuals with COPD', 'participants enrolled in the Lung Screen Uptake Trial (LSUT', 'Participants with a smoking history ≥30 pack-years and quit ≤15 years ago, or meeting a lung cancer risk of ≥1.51% via the Prostate Lung Colorectal Ovarian (PLCOm2012) model or ≥2.5% via the Liverpool Lung Project (LLP) model, were offered LDCT']","['LDCT', 'computed tomography (LDCT']","['Emphysema prevalence', 'Prevalence, Symptom Burden and Under-Diagnosis of Chronic Obstructive Pulmonary Disease', 'symptom prevalence, airflow limitation and visually graded emphysema', 'airflow obstruction']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4555205', 'cui_str': 'Ex-Smokers'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0013990', 'cui_str': 'Emphysema'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",,0.146541,"Inhaler use and symptoms were more common in the 'known' than the 'undiagnosed' COPD group (63% vs. 33% with persistent cough [p<0.001], 73% vs. 33% with dyspnoea [p<0.001]).","[{'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Ruparel', 'Affiliation': 'University College London, 4919, Lungs For Living Research Centre, London, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Quaife', 'Affiliation': 'University College London Research Department of Epidemiology and Public Health, 66046, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Dickson', 'Affiliation': 'University College London Lungs for Living Research Centre, 443274, London, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Horst', 'Affiliation': 'University College London, 4919, carolyn.horst@ucl.ac.uk, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Tisi', 'Affiliation': 'University College London, 4919, Lungs for Living Research Centre, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hall', 'Affiliation': 'University College London, 4919, Lungs for Living Research Centre, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Magali N', 'Initials': 'MN', 'LastName': 'Taylor', 'Affiliation': 'University College London Hospitals NHS Foundation Trust, 8964, Radiology Department, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Asia', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'University College London Hospitals NHS Foundation Trust, 8964, Radiology Department, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Penny J', 'Initials': 'PJ', 'LastName': 'Shaw', 'Affiliation': 'University College London Hospitals NHS Foundation Trust, 8964, Radiology Department, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Burke', 'Affiliation': 'Homerton University Hospital NHS Foundation Trust, 4721, Radiology Department, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'May-Jan', 'Initials': 'MJ', 'LastName': 'Soo', 'Affiliation': 'Homerton University Hospital NHS Foundation Trust, 4721, Radiology Department, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'University College London Hospitals NHS Foundation Trust, 8964, Radiology Department, London, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Devaraj', 'Affiliation': 'Royal Brompton Hospital, 156726, Radiology Department, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sennett', 'Affiliation': 'Killick Street Health Centre, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hurst', 'Affiliation': 'University College London, 4919, UCL Centre for Inflammation and Repair, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, 4952, Wolfson Institute of Preventive Medicine, London, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Navani', 'Affiliation': 'University College London, 4919, Lungs for Living Research Centre, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Angshu', 'Initials': 'A', 'LastName': 'Bhowmik', 'Affiliation': 'Homerton University Hospital NHS Foundation Trust, 4721, London, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Nottingham City Hospital, 105589, Respiratory Medicine Unit, David Evans Research Centre, Nottingham, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Sam M', 'Initials': 'SM', 'LastName': 'Janes', 'Affiliation': 'University College London, 4919, Lungs for Living Research Centre, London, United Kingdom of Great Britain and Northern Ireland; s.janes@ucl.ac.uk.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201911-857OC']
990,32157328,Effectiveness of transdermal nicotine patch in premenopausal female smokers is moderated by within-subject severity of negative affect and physical symptoms.,"RATIONALE


Nicotine patches may be less effective in female compared with male smokers. However, it is unknown if negative affect and physical symptoms influence transdermal nicotine patch-related effects on smoking behaviors.
METHODS


Eighty-one acutely tobacco-abstinent premenopausal female smokers attended three counter-balanced experimental sessions across the menstrual cycle (early follicular, late follicular, and mid-luteal) and were randomized to patch condition (nicotine [21 mg] vs. placebo [0 mg] transdermal patch). Negative affect and physical symptoms were assessed prior to patch administration. The patch was removed 5 h post-administration, and participants completed a smoking reinstatement task. Multilevel linear models tested associations of patch condition, negative affect and physical symptoms, and their interaction on smoking behavior.
RESULTS


There was a significant patch condition × Negative Affect and Pain symptoms interaction on the number of cigarettes smoked (p < 0.05). When Negative Affect and Pain were lower-than-usual, females administered a nicotine patch smoked significantly fewer cigarettes than females administered a placebo patch (p < .05), but there were no significant patch differences when Negative Affect and Pain were higher-than-usual. There was also a significant patch condition × Negative Affect interaction on time delay. The effects of patch condition on time delay to smoking were greater during sessions in which Negative Affect was higher-than-usual.
CONCLUSIONS


Results suggest that among female smokers transdermal nicotine patch effectiveness may interact with negative affect and pain. Understanding and considering female-specific factors that may impact the efficacy of one of the most commonly used cessation medications is important for improving smoking cessation in female smokers.",2020,"When Negative Affect and Pain were lower-than-usual, females administered a nicotine patch smoked significantly fewer cigarettes than females administered a placebo patch (p < .05), but there were no significant patch differences when Negative Affect and Pain were higher-than-usual.","['Eighty-one acutely tobacco-abstinent premenopausal female smokers attended three counter-balanced experimental sessions across the menstrual cycle (early follicular, late follicular, and mid-luteal', 'premenopausal female smokers', 'female compared with male smokers', 'female smokers']","['transdermal nicotine', 'transdermal nicotine patch', 'patch condition (nicotine [21\xa0mg] vs. placebo [0\xa0mg] transdermal patch']","['time delay to smoking', 'time delay', 'Pain', 'Pain symptoms interaction', 'Negative affect and physical symptoms']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0991556', 'cui_str': 'Transdermal System'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",81.0,0.0122859,"When Negative Affect and Pain were lower-than-usual, females administered a nicotine patch smoked significantly fewer cigarettes than females administered a placebo patch (p < .05), but there were no significant patch differences when Negative Affect and Pain were higher-than-usual.","[{'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Chai', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, 2001 N Soto Street, 312E, Los Angeles, CA, 90032, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Leventhal', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, 2001 N Soto Street, 312E, Los Angeles, CA, 90032, USA.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, 2001 N Soto Street, 312E, Los Angeles, CA, 90032, USA.'}, {'ForeName': 'Tory A', 'Initials': 'TA', 'LastName': 'Eisenlohr-Moul', 'Affiliation': 'Department of Psychiatry, University of Illinois Chicago, Chicago, IL, USA.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Rapkin', 'Affiliation': 'Department of Obstetrics and Gynecology, Center for the Health Sciences, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': ""D'Orazio"", 'Affiliation': 'Department of Neurology, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Raina D', 'Initials': 'RD', 'LastName': 'Pang', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, 2001 N Soto Street, 312E, Los Angeles, CA, 90032, USA. rpang@usc.edu.'}]",Psychopharmacology,['10.1007/s00213-020-05494-z']
991,30979672,"Patient-Specific Instrumentation Does Not Affect Rotational Alignment of the Femoral Component and Perioperative Blood Loss in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial.","BACKGROUND


Proposed aims of patient-specific instrumentation (PSI) for total knee arthroplasty (TKA) are to improve accuracy of component alignment, while reducing blood loss and surgical time. The primary goal of this prospective, randomized, controlled, clinical trial is to verify whether PSI improves the rotational alignment of the femoral component in comparison to conventionally implanted TKA.
METHODS


One-hundred thirty-three consecutive patients were assessed for eligibility. Block randomization was performed to allocated patients in the treatment (PSI) or control group. During hospital stay, surgical times were recorded, and total blood volume loss and estimated red blood cell were calculated. Two months after surgery, a computed tomography of the knee was obtained to measure femoral component rotation to the transepicondylar axis and tibial component slope.
RESULTS


Sixty-nine patients were enrolled. PSI did neither result in a significant improvement in femoral component rotation nor result in a reduction of outliers, as compared with conventional instrumentation. No significant improvement in terms of tibial slope, blood loss, total surgical time, and ischemia time could be identified. The number of tibial recuts required in the PSI group was significantly higher than in the control group (P = .0003).
CONCLUSION


PSI does not improve the accuracy of femoral component rotation in TKA in comparison to conventional instrumentation. Moreover, PSI did not appear to influence any of the other variables investigated as secondary goals by this study. The results of this study do not support its routine use during standard TKA.
LEVEL OF EVIDENCE


Level I, randomized, controlled trial.",2019,"The number of tibial recuts required in the PSI group was significantly higher than in the control group (P = .0003).
","['One-hundred thirty-three consecutive patients were assessed for eligibility', 'Sixty-nine patients were enrolled', 'Total Knee Arthroplasty', 'total knee arthroplasty (TKA']","['patient-specific instrumentation (PSI', 'PSI']","['accuracy of femoral component rotation', 'blood loss and surgical time', 'number of tibial recuts', 'total blood volume loss and estimated red blood cell', 'femoral component rotation', 'tibial slope, blood loss, total surgical time, and ischemia time']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C1706489', 'cui_str': 'Psi'}]","[{'cui': 'C0449434', 'cui_str': 'Femoral component (attribute)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0429890', 'cui_str': 'Total blood volume (observable entity)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",133.0,0.0890495,"The number of tibial recuts required in the PSI group was significantly higher than in the control group (P = .0003).
","[{'ForeName': 'Pietro S', 'Initials': 'PS', 'LastName': 'Randelli', 'Affiliation': 'Department of Biomedical Sciences for Health, Laboratory of Applied Biomechanics, Università degli Studi di Milano, Milan, Italy; 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Menon', 'Affiliation': 'Department of Biomedical Sciences for Health, Laboratory of Applied Biomechanics, Università degli Studi di Milano, Milan, Italy; 1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Pasqualotto', 'Affiliation': 'Divisione di Ortopedia e Traumatologia, IRCCS Ospedale Classificato Equiparato Sacro Cuore - Don Calabria, Negrar, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Zanini', 'Affiliation': 'Dipartimento di Scienze della Salute, Università del Piemonte Orientale A. Avogadro, Novara, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Compagnoni', 'Affiliation': '1° Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO, Milan, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Cucchi', 'Affiliation': 'Department of Biomedical Sciences for Health, Laboratory of Applied Biomechanics, Università degli Studi di Milano, Milan, Italy; Department of Orthopaedics and Trauma Surgery, Universitätsklinikum Bonn, Bonn, Germany.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.03.018']
992,32157623,Acceptability of a Computer-Tailored Safer Sex Intervention for Heterosexually Active African Americans Attending an STI Clinic.,"Since African Americans are disproportionately affected by HIV/AIDS, interventions that increase correct and consistent condom use are urgently needed. We report baseline acceptability data from a randomized controlled trial (RCT) testing the Tailored Information Program for Safer Sex, a computer-tailored intervention designed to increase correct and consistent condom use among low income, heterosexually active African Americans attending an urban sexually transmitted infection (STI) clinic. We enrolled 274 participants at baseline in an RCT-147 in the intervention group. The intervention had high acceptability, with a mean acceptability of 4.35 on a 5-point scale. We conducted a multiple regression analysis examining demographic, structural, and sexual risk characteristics that revealed only sex to be significantly (p < .01) associated with intervention acceptability. While women were more likely than men to find the intervention acceptable, overall the results indicated broad acceptability of this intervention to the target audience. eHealth interventions are a viable option for HIV prevention among African Americans visiting a publicly-funded STI clinic. We discuss implications of these results for the future application of such programs.",2020,"While women were more likely than men to find the intervention acceptable, overall the results indicated broad acceptability of this intervention to the target audience.","['African Americans visiting a publicly-funded STI clinic', '274 participants at baseline in an RCT-147 in the intervention group', 'Since African Americans', 'African Americans attending an urban sexually transmitted infection (STI) clinic', 'Heterosexually Active African Americans Attending an STI Clinic']",['Computer-Tailored Safer Sex Intervention'],[],"[{'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}]",[],274.0,0.0311334,"While women were more likely than men to find the intervention acceptable, overall the results indicated broad acceptability of this intervention to the target audience.","[{'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Noar', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina at Chapel Hill, 382 Carroll Hall, Campus Box 3365, Chapel Hill, NC, 27599-3365, USA. noar@unc.edu.'}, {'ForeName': 'Jessica Fitts', 'Initials': 'JF', 'LastName': 'Willoughby', 'Affiliation': 'The Edward R. Murrow College of Communication, Washington State University, Pullman, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Crosby', 'Affiliation': 'College of Public Health, University of Kentucky, Lexington, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Webb', 'Affiliation': 'Department of Communication, University of South Carolina Aiken, Aiken, USA.'}, {'ForeName': 'Stephanie K', 'Initials': 'SK', 'LastName': 'Van Stee', 'Affiliation': 'Department of Communication and Media, University of Missouri-St. Louis, St. Louis, USA.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Feist-Price', 'Affiliation': 'College of Education, University of Kentucky, Lexington, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Davis', 'Affiliation': ', Louisville, KY, USA.'}]",The journal of primary prevention,['10.1007/s10935-020-00585-1']
993,31265139,Evaluation of Tailored Falls Education on Older Adults' Behavior Following Hospitalization.,"BACKGROUND


Older adults recently discharged from the hospital are known to be at risk of functional decline and falls. This study evaluated the effect of a tailored education program provided in the hospital on older adult engagement in fall prevention strategies within 6 months after hospital discharge.
METHODS


A process evaluation of a randomized controlled trial that aimed to improve older adult fall prevention behaviors after hospital discharge. Participants (n = 390) were aged 60 years and older with good cognitive function (greater than 7 of 10 Abbreviated Mental Test Score), discharged home from three hospital rehabilitation wards in Perth, Australia. The primary outcomes were engagement in fall prevention strategies, including assistance with daily activities, home modifications, and exercise. Data were analyzed using generalized linear modeling.
RESULTS


There were 76.4% (n = 292) of participants who completed the final interview (n = 149 intervention, n = 143 control). There were no significant differences between groups in engagement in fall prevention strategies, including receiving instrumental activity of daily living (IADL) assistance (adjusted odds ratio [AOR] = 1.3 [95% confidence interval {CI} = 0.7-2.1]; P = .3), completion of home modifications (AOR = 1.2 [95% CI = 0.7-1.9]; P = .4), and exercise (AOR = 1.3 [95% CI = 0.7-2.2]; P = .3). There was a high proportion of unmet ADL needs within both groups, and levels of participant dependency remained higher at 6 months compared to baseline levels at admission. The proportion of all participants who engaged in exercise following hospital discharge increased by 30%; however, the mean duration of exercise reduced from 3 hours per week at baseline to 1 hour per week at 6-month follow-up (SD = 1.12 hours per week).
CONCLUSION


Tailored education did not increase older adult engagement in fall prevention strategies after hospital discharge compared to usual care. Further research is required to evaluate older adults' capacity to change their behaviors once they return home from hospital, which may enable a safer recovery of their independence. J Am Geriatr Soc 67:2274-2281, 2019.",2019,"There were no significant differences between groups in engagement in fall prevention strategies, including receiving instrumental activity of daily living (IADL) assistance (adjusted odds ratio [AOR] = 1.3 [95% confidence interval {CI} = 0.7-2.1]; P = .3), completion of home modifications (AOR = 1.2 [95% CI = 0.7-1.9]; P = .4), and exercise (AOR = 1.3 [95% CI = 0.7-2.2]; P = .3).","['Older adults', 'Participants (n = 390) were aged 60\u2009years and older with good cognitive function (greater than 7 of 10 Abbreviated Mental Test Score), discharged home from three hospital rehabilitation wards in Perth, Australia', 'older adult engagement in fall prevention strategies within 6 months after hospital discharge', ""Older Adults' Behavior Following Hospitalization"", 'older adult fall prevention behaviors after hospital discharge']","['Tailored Falls Education', 'tailored education program']","['mean duration of exercise', 'engagement in fall prevention strategies, including assistance with daily activities, home modifications, and exercise', 'receiving instrumental activity of daily living (IADL) assistance', 'hospital discharge', 'completion of home modifications']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2960765', 'cui_str': 'Abbreviated mental test score'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1321116', 'cui_str': 'Fall prevention behavior'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",390.0,0.201407,"There were no significant differences between groups in engagement in fall prevention strategies, including receiving instrumental activity of daily living (IADL) assistance (adjusted odds ratio [AOR] = 1.3 [95% confidence interval {CI} = 0.7-2.1]; P = .3), completion of home modifications (AOR = 1.2 [95% CI = 0.7-1.9]; P = .4), and exercise (AOR = 1.3 [95% CI = 0.7-2.2]; P = .3).","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Naseri', 'Affiliation': 'School of Physiotherapy and Exercise Sciences, Faculty of Health Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Terrence P', 'Initials': 'TP', 'LastName': 'Haines', 'Affiliation': 'Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Meg E', 'Initials': 'ME', 'LastName': 'Morris', 'Affiliation': 'Healthscope and La Trobe Centre for Sport and Exercise Medicine Research, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Etherton-Beer', 'Affiliation': 'Western Australian Centre for Health and Ageing, University of Western Australia, Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Shorr', 'Affiliation': 'Malcom Randall VA Medical Center, Geriatric Research Education and Clinical Center, Gainesville, Florida.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Flicker', 'Affiliation': 'Western Australian Centre for Health and Ageing, Centre for Medical Research, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bulsara', 'Affiliation': 'Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Netto', 'Affiliation': 'School of Occupational Therapy and Social Work, Faculty of Health Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Den-Ching A', 'Initials': 'DA', 'LastName': 'Lee', 'Affiliation': 'Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Francis-Coad', 'Affiliation': 'School of Physiotherapy, Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Waldron', 'Affiliation': 'Department of Geriatric Rehabilitation, Armadale Health Service, Department of Health, Mount Nasura, Western Australia, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Boudville', 'Affiliation': 'Department of Aged Care and Rehabilitation, St John of God Health Care, Midland, Western Australia, Australia.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Sciences, Faculty of Health Science, Curtin University, Perth, Western Australia, Australia.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16053']
994,31092660,Integrating a brief mental health intervention into primary care services for patients with HIV and diabetes in South Africa: study protocol for a trial-based economic evaluation.,"INTRODUCTION


Depression and alcohol use disorders are international public health priorities for which there is a substantial treatment gap. Brief mental health interventions delivered by lay health workers in primary care services may reduce this gap. There is limited economic evidence assessing the cost-effectiveness of such interventions in low-income and middle-income countries. This paper describes the proposed economic evaluation of a health systems intervention testing the effectiveness, cost-effectiveness and cost-utility of two task-sharing approaches to integrating services for common mental disorders with HIV and diabetes primary care services.
METHODS AND ANALYSIS


This evaluation will be conducted as part of a three-armed cluster randomised controlled trial of clinical effectiveness. Trial clinical outcome measures will include primary outcomes for risk of depression and alcohol use, and secondary outcomes for risk of chronic disease (HIV and diabetes) treatment failure. The cost-effectiveness analysis will evaluate cost per unit change in Alcohol Use Disorder Identification Test and Centre for Epidemiological Studies scale on Depression scores as well as cost per unit change in HIV RNA viral load and haemoglobin A1c, producing results of provider and patient cost per patient year for each study arm and chronic disease. The cost utility analyses will provide results of cost per quality-adjusted life year gained. Additional analyses relevant for implementation including budget impact analyses will be conducted to inform the development of a business case for scaling up the country's investment in mental health services.
ETHICS AND DISSEMINATION


The Western Cape Department of Health (WCDoH) (WC2016_RP6_9), the South African Medical Research Council (EC 004-2/2015), the University of Cape Town (089/2015) and Oxford University (OxTREC 2-17) provided ethical approval for this study. Results dissemination will include policy briefs, social media, peer-reviewed papers, a policy dialogue workshop and press briefings.
TRIAL REGISTRATION NUMBER


PACTR201610001825405.",2019,"Additional analyses relevant for implementation including budget impact analyses will be conducted to inform the development of a business case for scaling up the country's investment in mental health services.
","['patients with HIV and diabetes in South Africa', 'common mental disorders with HIV and diabetes primary care services']","['mental health intervention', 'two task-sharing approaches to integrating services']","['risk of depression and alcohol use, and secondary outcomes for risk of chronic disease (HIV and diabetes) treatment failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0162643'}]",,0.106784,"Additional analyses relevant for implementation including budget impact analyses will be conducted to inform the development of a business case for scaling up the country's investment in mental health services.
","[{'ForeName': 'Vimbayi', 'Initials': 'V', 'LastName': 'Mutyambizi-Mafunda', 'Affiliation': 'Health Economics Unit, University of Cape Town School of Public Health and Family Medicine, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Myers', 'Affiliation': 'Alcohol and Drug Abuse Research Unit, South African Medical Research Council, Tygerburg, Western Cape, South Africa.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Sorsdahl', 'Affiliation': 'Department of Psychiatry and Mental Health, Alan J Flisher Centre for Public Mental Health, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': 'Department of Psychiatry and Mental Health, Alan J Flisher Centre for Public Mental Health, University of Cape Town, Cape Town, Western Cape, South Africa.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Naledi', 'Affiliation': 'Desmond Tutu HIV Research Centre, University of Cape Town School of Public Health and Family Medicine, Observatory, Western Cape, South Africa.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cleary', 'Affiliation': 'Health Economics Unit, School of Public Health and Family Medicine, University of Cape Town, Observatory, Western Cape, South Africa.'}]",BMJ open,['10.1136/bmjopen-2018-026973']
995,31092664,MyBackPain-evaluation of an innovative consumer-focused website for low back pain: study protocol for a randomised controlled trial.,"INTRODUCTION


Despite the prevalence of low back pain (LBP) worldwide, many people with the condition do not receive evidence-based care or achieve the best possible outcomes. There is a gap in the dissemination of evidence-based information across the globe. The advent of the internet has changed the way people obtain health information. As such, trustworthy, tailored and validated LBP resources may help bridge the gap. This study aims to measure the effectiveness of a new website (MyBackPain) in improving spinal health literacy, treatment preferences and clinical outcomes for people with LBP, in comparison with other online resources.
METHODS AND ANALYSIS


This online, pragmatic, randomised controlled trial will comprise 440 people with non-specific LBP of any duration. In addition to access to publicly available online information (control group), the intervention group will be given access to the MyBackPain.org.au website. Participants and research staff, including the biostatistician, will be blinded to treatment allocation. Data will be collected at baseline, 1, 3 (primary end-point), 6 and 12 months via online surveys and questionnaires. The primary outcome is spinal health literacy. Secondary outcomes include quality of treatment preferences (stated and observed) and LBP clinical outcomes (pain, disability and quality of life). Analyses will be by intention-to-treat and include outcome data on all randomised participants. Descriptive statistics will be presented for demographic and clinical characteristics.
ETHICS AND DISSEMINATION


This trial has been prospectively registered with the Australian New Zealand Clinical Trials Registry and has ethical approval from the University of Queensland Human Research Ethics Committee (2017000995). Trial outcomes will be shared via national and international conference presentations and peer-reviewed journal publications.
TRIAL REGISTRATION NUMBER


ACTRN12617001292369; Pre-results.",2019,"This study aims to measure the effectiveness of a new website (MyBackPain) in improving spinal health literacy, treatment preferences and clinical outcomes for people with LBP, in comparison with other online resources.
","['440 people with non-specific LBP of any duration', 'people with LBP, in comparison with other online resources']","['MyBackPain-evaluation of an innovative consumer-focused website', 'new website (MyBackPain']","['quality of treatment preferences (stated and observed) and LBP clinical outcomes (pain, disability and quality of life', 'spinal health literacy']","[{'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034380'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",440.0,0.2827,"This study aims to measure the effectiveness of a new website (MyBackPain) in improving spinal health literacy, treatment preferences and clinical outcomes for people with LBP, in comparison with other online resources.
","[{'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Hall', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Ferreira', 'Affiliation': 'Institute of Bone and Joint Research, University of Sydney, Saint Leonards, New South Wales, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Setchell', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'French', 'Affiliation': 'Department of Chiropractic, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'CHESM, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hunter', 'Affiliation': 'The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'Physiotherapy, The University of Queensland, Queensland, Queensland, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Dickson', 'Affiliation': 'Arthritis Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hodges', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-027516']
996,31092666,PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial.,"INTRODUCTION


Frailty is a multidimensional syndrome in which multiple small physiological deficits accumulate gradually, resulting in a loss of physiological reserve and adaptability, putting a patient that is exposed to a stressor at a higher risk of adverse outcomes. Both pre-frailty and frailty are associated with poor patient outcomes and higher healthcare costs. The effect of a prehabilitation programme and standard care on the quality of recovery in pre-frail and frail patients undergoing elective cardiac surgery will be compared.
METHOD AND ANALYSIS


A single-centre, superiority, stratified randomised controlled trial with a blinded outcome assessment and intention-to-treat analysis. Pre-frail and frail patients awaiting elective coronary artery bypass graft, with or without valvular repair/replacement, will be recruited. 164 participants will be randomly assigned to either prehabilitation (intervention) or standard care (no intervention) groups. The prehabilitation group will attend two sessions/week of structured exercise (aerobic and resistance) training, supervised by a physiotherapist, for 6-10 weeks before surgery with early health promotion advice in addition to standard care. The standard care group will receive the usual routine care (no prehabilitation). Frailty will be assessed at baseline, hospital admission and at 1 and 3 months after surgery. The primary outcomes will be participants' perceived quality of recovery (15-item Quality of Recovery questionnaire) after surgery (day 3), days at home within 30 days of surgery and the changes in WHO Disability Assessment Schedule 2.0 score between baseline and at 1 and 3 months after surgery. Secondary outcomes will include major adverse cardiac and cerebrovascular events, psychological distress levels, health-related quality of life and healthcare costs.
ETHICS AND DISSEMINATION


The Joint CUHK-NTEC Clinical Research Ethics Committee approved the study protocol (CREC Ref. No. 2017.696 T). The findings will be presented at scientific meetings, in peer-reviewed journals and to study participants.
TRIAL REGISTRATION NUMBER


ChiCTR1800016098; Pre-results.",2019,"The effect of a prehabilitation programme and standard care on the quality of recovery in pre-frail and frail patients undergoing elective cardiac surgery will be compared.
","['164 participants', 'Pre-frail and frail patients awaiting elective coronary artery bypass graft, with or without valvular repair/replacement, will be recruited', 'pre-frail and frail patients undergoing elective cardiac surgery']","['structured exercise (aerobic and resistance) training, supervised by a physiotherapist, for 6-10 weeks before surgery with early health promotion advice in addition to standard care', 'prehabilitation (intervention) or standard care (no intervention', 'prehabilitation programme and standard care', 'usual routine care (no prehabilitation']","['quality of recovery', 'major adverse cardiac and cerebrovascular events, psychological distress levels, health-related quality of life and healthcare costs', 'quality of recovery (15-item Quality of Recovery questionnaire) after surgery (day 3), days at home within 30 days of surgery and the changes in WHO Disability Assessment Schedule 2.0 score']","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C3887296', 'cui_str': 'Within thirty days of surgery (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C4304971', 'cui_str': 'World Health Organization Disability Assessment Schedule 2.0 (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",164.0,0.157963,"The effect of a prehabilitation programme and standard care on the quality of recovery in pre-frail and frail patients undergoing elective cardiac surgery will be compared.
","[{'ForeName': 'Derek King Wai', 'Initials': 'DKW', 'LastName': 'Yau', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Man Kin Henry', 'Initials': 'MKH', 'LastName': 'Wong', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Prince of Wales Hospital, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Wai-Tat', 'Initials': 'WT', 'LastName': 'Wong', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Gin', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Malcolm John', 'Initials': 'MJ', 'LastName': 'Underwood', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Gavin Mathew', 'Initials': 'GM', 'LastName': 'Joynt', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}]",BMJ open,['10.1136/bmjopen-2018-027974']
997,31060536,Evaluation of two SpO 2  alarm strategies during automated FiO 2  control in the NICU: a randomized crossover study.,"BACKGROUND


Changes in oxygen saturation (SpO 2 ) exposure have been shown to have a marked impact on neonatal outcomes and therefore careful titration of inspired oxygen is essential. In routine use, however, the frequency of SpO 2  alarms not requiring intervention results in alarm fatigue and its corresponding risk. SpO 2  control systems that automate oxygen adjustments (Auto-FiO 2 ) have been shown to be safe and effective. We speculated that when using Auto-FiO 2 , alarm settings could be refined to reduce unnecessary alarms, without compromising safety.
METHODS


An unblinded randomized crossover study was conducted in a single NICU among infants routinely managed with Auto-FiO 2 . During the first 6 days of respiratory support a tight and a loose alarm strategy were switched each 24 h. A balanced block randomization was used. The tight strategy set the alarms at the prescribed SpO 2  target range, with a 30-s delay. The loose strategy set the alarms 2 wider, with a 90-s delay. The effectiveness outcome was the frequency of SpO 2  alarms, and the safety outcomes were time at SpO 2  extremes (< 80, > 98%). We hypothesized that the loose strategy would result in a marked decrease in the frequency of SpO 2  alarms, and no increases at SpO 2  extremes with 20 subjects. Within subject differences between alarm strategies for the primary outcomes were evaluated with Wilcoxon signed-rank test.
RESULTS


During a 13-month period 26 neonates were randomized. The analysis included 21 subjects with 49 days of both tight and loose intervention. The loose alarm strategy resulted in a reduction in the median rate of SpO 2  alarms from 5.2 to 1.6 per hour (p <  0.001, 95%-CI difference 1.6-3.7). The incidence of hypoxemia and hyperoxemia were very low (less than 0.1%-time) with no difference associated with the alarm strategy (95%-CI difference less than 0.0-0.2%).
CONCLUSIONS


In this group of infants we found a marked advantage of the looser alarm strategy. We conclude that the paradigms of alarm strategies used for manual titration of oxygen need to be reconsidered when using Auto-FiO 2 . We speculate that with optimal settings false positive SpO 2  alarms can be minimized, with better vigilance of clinically relevant alarms.
TRIAL REGISTRATION


Retrospectively registered 15 May 2018 at ISRCTN ( 49239883 ).",2019,"The incidence of hypoxemia and hyperoxemia were very low (less than 0.1%-time) with no difference associated with the alarm strategy (95%-CI difference less than 0.0-0.2%).
","['infants routinely managed with Auto-FiO 2 ', '21 subjects with 49\u2009days of both tight and loose intervention']",[],"['incidence of hypoxemia and hyperoxemia', 'median rate of SpO 2  alarms', 'frequency of SpO 2  alarms, and the safety outcomes', 'Wilcoxon signed-rank test']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C0205407', 'cui_str': 'Loose (qualifier value)'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0336648', 'cui_str': 'Alarm, device (physical object)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",21.0,0.264246,"The incidence of hypoxemia and hyperoxemia were very low (less than 0.1%-time) with no difference associated with the alarm strategy (95%-CI difference less than 0.0-0.2%).
","[{'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Warakomska', 'Affiliation': 'Department of Neonatology, Independent Public Clinical Hospital of Prof W, Orlowski 231 Czerniakowska str, 00-416, Warsaw, Poland.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Bachman', 'Affiliation': 'Department Biomedical Technology, Faculty of Biomedical Engineering, Czech Technical University in Prague, Sitna 3105, 272 01, Kladno, Czech Republic.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wilinska', 'Affiliation': 'Department of Neonatology, Centre of Medical Postgraduate Education, 231 Czerniakowska str, 00-416, Warsaw, Poland. wilinska.maria@gmail.com.'}]",BMC pediatrics,['10.1186/s12887-019-1496-5']
998,31533841,Facilitating action planning within audit and feedback interventions: a mixed-methods process evaluation of an action implementation toolbox in intensive care.,"BACKGROUND


Audit and feedback (A&F) is more effective if it facilitates action planning, but little is known about how best to do this. We developed an electronic A&F intervention with an action implementation toolbox to improve pain management in intensive care units (ICUs); the toolbox contained suggested actions for improvement. A head-to-head randomised trial demonstrated that the toolbox moderately increased the intervention's effectiveness when compared with A&F only.
OBJECTIVE


To understand the mechanisms through which A&F with action implementation toolbox facilitates action planning by ICUs to increase A&F effectiveness.
METHODS


We extracted all individual actions from action plans developed by ICUs that received A&F with (n = 10) and without (n = 11) toolbox for 6 months and classified them using Clinical Performance Feedback Intervention Theory. We held semi-structured interviews with participants during the trial. We compared the number and type of planned and completed actions between study groups and explored barriers and facilitators to effective action planning.
RESULTS


ICUs with toolbox planned more actions directly aimed at improving practice (p = 0.037) and targeted a wider range of practice determinants compared to ICUs without toolbox. ICUs with toolbox also completed more actions during the study period, but not significantly (p = 0.142). ICUs without toolbox reported more difficulties in identifying what actions they could take. Regardless of the toolbox, all ICUs still experienced barriers relating to the feedback (low controllability, accuracy) and organisational context (competing priorities, resources, cost).
CONCLUSIONS


The toolbox helped health professionals to broaden their mindset about actions they could take to change clinical practice. Without the toolbox, professionals tended to focus more on feedback verification and exploring solutions without developing intentions for actual change. All feedback recipients experienced organisational barriers that inhibited eventual completion of actions.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02922101 . Registered on 26 September 2016.",2019,"ICUs with toolbox also completed more actions during the study period, but not significantly (p = 0.142).",[],['electronic A&F intervention with an action implementation toolbox'],"[""intervention's effectiveness""]",[],"[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0831549,"ICUs with toolbox also completed more actions during the study period, but not significantly (p = 0.142).","[{'ForeName': 'Wouter T', 'Initials': 'WT', 'LastName': 'Gude', 'Affiliation': 'Department of Medical Informatics, Amsterdam UMC, Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, The Netherlands. w.t.gude@amc.uva.nl.'}, {'ForeName': 'Marie-José', 'Initials': 'MJ', 'LastName': 'Roos-Blom', 'Affiliation': 'Department of Medical Informatics, Amsterdam UMC, Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Sabine N', 'Initials': 'SN', 'LastName': 'van der Veer', 'Affiliation': 'Centre for Health Informatics, Division of Informatics, Imaging and Data Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Dave A', 'Initials': 'DA', 'LastName': 'Dongelmans', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Evert', 'Initials': 'E', 'LastName': 'de Jonge', 'Affiliation': 'Department of Intensive Care Medicine, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Peek', 'Affiliation': 'Centre for Health Informatics, Division of Informatics, Imaging and Data Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Nicolette F', 'Initials': 'NF', 'LastName': 'de Keizer', 'Affiliation': 'Department of Medical Informatics, Amsterdam UMC, Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, The Netherlands.'}]",Implementation science : IS,['10.1186/s13012-019-0937-8']
999,31342329,Integrating a Medical Home in an Outpatient Dialysis Setting: Effects on Health-Related Quality of Life.,"BACKGROUND


Integrating primary care has been proposed to reduce fragmented care delivery for patients with complex medical needs. Because of their high rates of morbidity, healthcare use, and mortality, patients with end-stage kidney disease (ESKD) may benefit from increased access to a primary care medical home.
OBJECTIVE


To evaluate the effect of integrating a primary care medical home on health-related quality of life (HRQOL) for patients with ESKD receiving chronic hemodialysis.
DESIGN


Before-after intervention trial with repeated measures at two Chicago dialysis centers.
PARTICIPANTS


Patients receiving hemodialysis at either of the two centers.
INTERVENTION


To the standard hemodialysis team (nephrologist, nurse, social worker, dietitian), we added a primary care physician, a pharmacist, a nurse coordinator, and a community health worker. The intervention took place from January 2015 through August 2016.
MAIN MEASURES


Health-related quality of life, using the Kidney Disease Quality of Life (KDQOL) measures.
KEY RESULTS


Of 247 eligible patients, 175 (71%) consented and participated; mean age was 54 years; 55% were men and 97% were African American or Hispanic. In regression analysis adjusted for individual visits with the medical home providers and other factors, there were significant improvements in four of five KDQOL domains: at 12 and 18 months, the Mental Component Score improved from baseline (adjusted mean 49.0) by 2.64 (p = 0.01) and 2.96 (p = 0.007) points, respectively. At 6 and 12 months, the Symptoms domain improved from baseline (adjusted mean = 77.0) by 2.61 (p = 0.02) and 2.35 points (p = 0.05) respectively. The Kidney Disease Effects domain improved from baseline (adjusted mean = 72.7), to 6, 12, and 18 months by 4.36 (p = 0.003), 6.95 (p < 0.0001), and 4.14 (p = 0.02) points respectively. The Physical Component Score improved at 6 months only.
CONCLUSIONS


Integrating primary care and enhancing care coordination in two dialysis facilities was associated with improvements in HRQOL among patients with ESKD who required chronic hemodialysis.",2019,"The Kidney Disease Effects domain improved from baseline (adjusted mean = 72.7), to 6, 12, and 18 months by 4.36 (p = 0.003), 6.95 (p < 0.0001), and 4.14 (p = 0.02) points respectively.","['Patients receiving hemodialysis at either of the two centers', '175 (71%) consented and participated; mean age was 54\xa0years; 55% were men and 97% were African American or Hispanic', 'patients with ESKD who required chronic hemodialysis', 'patients with end-stage kidney disease (ESKD', 'patients with ESKD receiving chronic hemodialysis', '247 eligible patients', 'patients with complex medical needs']",[],"['Physical Component Score', 'Symptoms domain', 'Health-related quality of life, using the Kidney Disease Quality of Life (KDQOL) measures', 'Health-Related Quality of Life', 'Mental Component Score', 'health-related quality of life (HRQOL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",247.0,0.0347094,"The Kidney Disease Effects domain improved from baseline (adjusted mean = 72.7), to 6, 12, and 18 months by 4.36 (p = 0.003), 6.95 (p < 0.0001), and 4.14 (p = 0.02) points respectively.","[{'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Hynes', 'Affiliation': 'College of Public Health and Human Sciences and Center for Genome Research and Biocomputing, Oregon State University, Corvallis, OR, USA. hynesd@oregonstate.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Fitzgibbon', 'Affiliation': 'Department of Pediatrics, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Porter', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berbaum', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Ifeanyi B', 'Initials': 'IB', 'LastName': 'Chukwudozie', 'Affiliation': 'Office of Community Engaged Research and Implementation Science, University of Illinois Cancer Center, Chicago, IL, USA.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Nguyen', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Arruda', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Illinois at Chicago, Chicago, IL, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05154-9']
1000,31039482,Getting to precision psychopharmacology: Combining clinical and genetic information to predict fat gain from aripiprazole.,"INTRODUCTION


All atypical antipsychotics are associated with some degree of weight gain. We applied a novel statistical approach to identify moderators of aripiprazole-induced fat gain using clinical and genetic data from a randomized clinical trial (RCT) of treatment resistant depression in older adults.
MATERIALS AND METHODS


Adults aged ≥60 years with non-response to a prospective trial of venlafaxine were randomized to 12 weeks of aripiprazole augmentation (n = 91) or placebo (n = 90). Dual energy x-ray absorptiometry (DEXA) measured adiposity at baseline and 12 weeks. Independent moderators of total body fat gain were used to generate two combined multiple moderators, one including clinical data alone and one including both clinical and genetic data to characterize individuals who gained fat during aripiprazole augmentation.
RESULTS


The value of the combined genetic + clinical multiple moderator (M cg ) was 0.57 [95% CI 0.46, 0.68] (effect size: 0.57), compared to the combined clinical moderator (M c ) value of 0.49 [0.34, 0.63] (effect size: 0.49). Individuals who gained adiposity in this study were more likely to be female and younger in age, have lower weight, fasting glucose and lipids at baseline and positive for the HTR2C polymorphism.
DISCUSSION


These results demonstrate a combined multiple moderator approach, including both clinical and genetic moderators, can be applied to existing clinical trial data to understand adverse treatment effects. This method allowed for more specific characterization of individuals at risk for the outcome of interest. Further work is needed to identify additional genetic moderators and to validate the approach.",2019,"The value of the combined genetic + clinical multiple moderator (M cg ) was 0.57 [95% CI 0.46, 0.68] (effect size: 0.57), compared to the combined clinical moderator (M c ) value of 0.49 [0.34, 0.63] (effect size: 0.49).","['Adults aged ≥60 years with non-response to a prospective trial of', 'older adults']","['Dual energy x-ray absorptiometry (DEXA', 'placebo', 'venlafaxine', 'aripiprazole augmentation', 'aripiprazole-induced fat gain', 'aripiprazole']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]",[],,0.0339439,"The value of the combined genetic + clinical multiple moderator (M cg ) was 0.57 [95% CI 0.46, 0.68] (effect size: 0.57), compared to the combined clinical moderator (M c ) value of 0.49 [0.34, 0.63] (effect size: 0.49).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Oughli', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Locke', 'Affiliation': 'Washington University School of Medicine, Department of Internal Medicine, St. Louis, MO, USA.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Yingling', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'University of Pittsburgh Graduate School of Public Health, Department of Epidemiology, Pittsburgh, PA, USA.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Washington University School of Medicine, Division of Biostatistics, St. Louis, MO, USA.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'University of Pittsburgh Medical Center, Department of Psychiatry, Pittsburgh, PA, USA.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'University of Toronto, Department of Psychiatry and Center for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Newcomer', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA; Thriving Mind South Florida, Miami, FL, USA.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Peterson', 'Affiliation': 'Washington University School of Medicine, Department of Internal Medicine, St. Louis, MO, USA.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Müller', 'Affiliation': 'University of Toronto, Department of Psychiatry and Center for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Nicol', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA. Electronic address: nicolg@wustl.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.04.017']
1001,31097519,Cost-effectiveness of intrapleural use of tissue plasminogen activator and DNase in pleural infection: evidence from the MIST2 randomised controlled trial.,"The MIST2 (Second Multicentre Intrapleural Sepsis Trial) trial showed that combined intrapleural use of tissue plasminogen activator (t-PA) and recombinant human DNase was effective when compared with single agents or placebo. However, the treatment costs are significant and overall cost-effectiveness of combined therapy remains unclear.An economic evaluation of the MIST2 trial was performed to assess the cost-effectiveness of combined therapy. Costs included were those related to study medications, initial hospital stay and subsequent hospitalisations. Outcomes were measured in terms of life-years gained. All costs were reported in euro and in 2016 prices.Mean annual costs were lowest in the t-PA-DNase group (EUR 10 605 for t-PA, EUR 17 856 for DNase, EUR 13 483 for placebo and EUR 7248 for t-PA-DNase; p=0.209). Mean 1-year life expectancy was 0.988 for t-PA, 0.923 for DNase, and 0.969 for both placebo and t-PA-DNase (p=0.296). Both DNase and placebo were less effective, in terms of life-years gained, and more costly than t-PA. When placebo was compared with t-PA-DNase, the incremental cost per life-year gained of placebo was EUR 1.6 billion, with a probability of 0.85 of t-PA-DNase being cost-effective.This study demonstrates that combined t-PA-DNase is likely to be highly cost-effective. In light of this evidence, a definitive trial designed to facilitate a thorough economic evaluation is warranted to provide further evidence on the cost-effectiveness of this promising combined intervention.",2019,"Both DNase and placebo were less effective, in terms of life-years gained, and more costly than t-PA.",['pleural infection'],"['tissue plasminogen activator and DNase', 'placebo']","['Mean 1-year life expectancy', 'Mean annual costs', 'initial hospital stay, and subsequent hospitalisations', 'cost-effectiveness']",[{'cui': 'C0919907'}],"[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0011522', 'cui_str': 'Deoxyribonucleases'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.123983,"Both DNase and placebo were less effective, in terms of life-years gained, and more costly than t-PA.","[{'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Luengo-Fernandez', 'Affiliation': 'Health Economics Research Centre, Nuffield Dept of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Penz', 'Affiliation': 'Dept of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Dobson', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Dept of Clinical Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Psallidas', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Dept of Clinical Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Nunn', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Dept of Clinical Medicine, University of Oxford, Oxford, UK najib.rahman@ndm.ox.ac.uk.'}]",The European respiratory journal,['10.1183/13993003.01550-2018']
1002,31010364,Muscle Talk Online and Impression Formation Based on Body Type: Comparisons Between Asian American and Caucasian American Males.,"This study aimed to investigate how individuals form impressions about the self-esteem and life satisfaction of a male who engages in muscle talk on Facebook. The study examined (a) how a target's body build and peer-generated comments influence observers' impression of him, and (b) how such influences might be moderated by the cultural backgrounds of observers (Asian Americans and European Americans). A mock-up Facebook profile page was created in which two factors were manipulated: the target's body build (muscular, average, and overweight) and peer-generated messages (muscle encouraging and muscle discouraging), creating six different conditions. Male college students ( N = 508) were randomly assigned to one of the conditions. After viewing a mock-up Facebook page online, participants completed an online questionnaire assessing their impressions of the target's self-esteem and life satisfaction. Results showed that a muscular target was perceived as possessing higher levels of self-esteem and life satisfaction. Observers rated the target as having higher self-esteem when the target received muscle-encouraging messages than when the target received muscle-discouraging messages. No cultural differences were identified. Findings suggest the existence of weight bias when forming psychological impressions of others online. Findings also confirmed the important role of peer-generated messages in the impression formation process online.",2019,Observers rated the target as having higher self-esteem when the target received muscle-encouraging messages than when the target received muscle-discouraging messages.,"['Asian American and Caucasian American Males', 'male who engages in muscle talk on Facebook', 'cultural backgrounds of observers (Asian Americans and European Americans', 'Male college students ( N = 508']",['Muscle Talk Online and Impression Formation Based on Body Type'],['self-esteem and life satisfaction'],"[{'cui': 'C0003988', 'cui_str': 'Asian Americans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0010447', 'cui_str': 'Cultural Background'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0037669', 'cui_str': 'Body Build'}]","[{'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",508.0,0.0446839,Observers rated the target as having higher self-esteem when the target received muscle-encouraging messages than when the target received muscle-discouraging messages.,"[{'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Taniguchi', 'Affiliation': ""1 Department of Communicology, University of Hawai'i at Mānoa, Honolulu, HI, USA.""}, {'ForeName': 'Hye Eun', 'Initials': 'HE', 'LastName': 'Lee', 'Affiliation': '2 School of Communication & Media, Ewha Womans University, Seodaemun-gu, Seoul, South Korea.'}]",American journal of men's health,['10.1177/1557988319845811']
1003,31075612,Cookie or clementine? Psychophysiological stress reactivity and recovery after eating healthy and unhealthy comfort foods.,"Many people eat unhealthy foods that are high in calories, fat, or sugar when feeling stressed, yet little is known about whether this unhealthy comfort eating actually comforts. Additionally, prior research has not tested whether healthy comfort eating of fruits and vegetables might also alleviate stress, or whether comfort eating during the stress anticipation phase versus immediately after a stressful event is more beneficial for stress relief. The present experiment tested whether unhealthy and healthy comfort eating reduce acute psychophysiological responses to a socially evaluative stressor. Participants (N = 150 healthy women) underwent the Trier Social Stress Test in the lab and were randomly assigned to one of five conditions according to a 2 (food type: unhealthy vs. healthy) x 2 (eating timing: during stress anticipation vs. after the stressor) + 1 (no food control) between-subjects design. Stress outcomes included mood, cognitive appraisals, rumination, salivary cortisol, heart rate variability, and pre-ejection period. Unhealthy and healthy comfort eating did not dampen reactivity or enhance recovery of psychophysiological stress compared to control, and no differences in reactivity or recovery were found by comfort food type. Findings suggest that by replacing unhealthy comfort foods with fruits and vegetables, women will not be sacrificing any stress-reducing benefits and can inherently improve the quality of their diet while avoiding potential drawbacks of unhealthy comfort eating (e.g., links with abdominal obesity).",2019,"Unhealthy and healthy comfort eating did not dampen reactivity or enhance recovery of psychophysiological stress compared to control, and no differences in reactivity or recovery were found by comfort food type.","['after eating healthy and unhealthy comfort foods', 'Participants (N = 150 healthy women) underwent the Trier Social Stress Test in the lab and were randomly assigned to one of five conditions according to a 2 (food type: unhealthy vs. healthy']","['Cookie or clementine', 'unhealthy and healthy comfort eating']","['mood, cognitive appraisals, rumination, salivary cortisol, heart rate variability, and pre-ejection period', 'reactivity or recovery', 'psychophysiological stress', 'Psychophysiological stress reactivity and recovery']","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C3853210', 'cui_str': 'Cookie (substance)'}, {'cui': 'C0453272', 'cui_str': 'Clementine (substance)'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",150.0,0.0205023,"Unhealthy and healthy comfort eating did not dampen reactivity or enhance recovery of psychophysiological stress compared to control, and no differences in reactivity or recovery were found by comfort food type.","[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Finch', 'Affiliation': 'University of California, Los Angeles, Department of Psychology, 1285 Franz Hall, 502 Portola Plaza, Los Angeles, CA 90095, USA. Electronic address: laura.finch@northwestern.edu.'}, {'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Cummings', 'Affiliation': 'University of California, Los Angeles, Department of Psychology, 1285 Franz Hall, 502 Portola Plaza, Los Angeles, CA 90095, USA. Electronic address: jennarc@umich.edu.'}, {'ForeName': 'A Janet', 'Initials': 'AJ', 'LastName': 'Tomiyama', 'Affiliation': 'University of California, Los Angeles, Department of Psychology, 1285 Franz Hall, 502 Portola Plaza, Los Angeles, CA 90095, USA. Electronic address: tomiyama@psych.ucla.edu.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.04.022']
1004,31092668,Examining the effectiveness of a web-based intervention for symptoms of depression and anxiety in college students: study protocol of a randomised controlled trial.,"INTRODUCTION


The college years are a peak period for the onset of common mental disorders. Poor mental health is associated with low academic attainment, physical, interpersonal and cognitive impairments. Universities can use online approaches to screen students for mental disorders and treat those in need. The present study aims to assess the effectiveness of a guided web-based transdiagnostic individually tailored intervention to treat students with symptoms of depression and/or anxiety.
METHODS


and analysis  : The present study is a randomised controlled trial. Participants are Dutch college students (≥18 years) with mild to moderate depression and/or anxiety symptoms. The intervention is a guided web-based transdiagnostic individually tailored intervention that targets symptoms of depression and/or anxiety. The intervention consists of seven online sessions with a duration ranging from 4 to 7 weeks depending on individual progress. A booster session is administered 4 weeks after the completion of the seventh session. Primary outcome measures are the Patient Health Questionnaire for depression and the Generalised Anxiety Disorder 7-item scale for anxiety. These scales are administered at screening, post-treatment and follow-up assessments (6 and 12 months post-randomisation). :  E  THICS AND DISSEMINATION: The Medical Ethics Committee of the Vrije Universiteit Medical Centre has approved the protocol (registration number 2016.583, A2017.362andA2018.421). Results of the trial will be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NTR6797; Pre-results.",2019,The intervention is a guided web-based transdiagnostic individually tailored intervention that targets symptoms of depression and/or anxiety.,"['and analysis  ', 'college students', 'Participants are Dutch college students (≥18 years) with mild to moderate depression and/or anxiety symptoms', 'students with symptoms of depression and/or anxiety']","['web-based intervention', 'guided web-based transdiagnostic individually tailored intervention']",['Patient Health Questionnaire for depression and the Generalised Anxiety Disorder 7-item scale for anxiety'],"[{'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3874856', 'cui_str': 'Generalized anxiety disorder 7 item scale (assessment scale)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.158998,The intervention is a guided web-based transdiagnostic individually tailored intervention that targets symptoms of depression and/or anxiety.,"[{'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Karyotaki', 'Affiliation': 'Department of Clinical, Neuro, and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Anke M', 'Initials': 'AM', 'LastName': 'Klein', 'Affiliation': 'Addiction, Development, and Psychopathology Lab, Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Riper', 'Affiliation': 'Department of Clinical, Neuro, and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Leonore de', 'Initials': 'L', 'LastName': 'Wit', 'Affiliation': 'Department of Clinical, Neuro, and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Krijnen', 'Affiliation': 'Department of Clinical, Neuro, and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Bol', 'Affiliation': 'Department of Clinical, Neuro, and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bolinski', 'Affiliation': 'Department of Clinical, Neuro, and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Burger', 'Affiliation': 'Department of Clinical, Neuro, and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical, Neuro, and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Randy P', 'Initials': 'RP', 'LastName': 'Auerbach', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Kessler', 'Affiliation': 'Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'Bruffaerts', 'Affiliation': 'Universitair Psychiatrisch Centrum, Centre for Public Health Psychiatry, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Neeltje', 'Initials': 'N', 'LastName': 'Batelaan', 'Affiliation': 'Department of Psychiatry and Department of Epidemiology and Biostatistics, VU University Medical Centre Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Research, Development and Prevention, Student Health Service University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vonk', 'Affiliation': 'Department of Research, Development and Prevention, Student Health Service University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Kleiboer', 'Affiliation': 'Department of Clinical, Neuro, and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Reinout W', 'Initials': 'RW', 'LastName': 'Wiers', 'Affiliation': 'Addiction, Development, and Psychopathology Lab, Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro, and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2018-028739']
1005,31092670,Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials.,"INTRODUCTION


This article describes two randomised controlled trials that will evaluate the effectiveness and cost-effectiveness of Self-Help Plus (SH+), a group self-help intervention developed by the WHO to reduce distress. In these trials SH+ is being tested as a preventative intervention to lower the incidence of mental disorders in asylum seekers and refugees with psychological distress resettled in Europe and Turkey.
METHODS AND ANALYSIS


Two prospective, multicentre, randomised, rater-blinded, parallel-group studies will follow participants over a period of 12 months. One trial will be conducted in Europe and one in Turkey. In each trial, 600 asylum seekers and refugees screening positive on the General Health Questionnaire (≥3), but without a formal diagnosis of any mental disorders according to the Mini International Neuropsychiatric Interview, will be randomly allocated to SH+or to enhanced treatment-as-usual. The primary outcome will be a lower incidence of mental disorders at 6 month follow-up. Secondary outcomes will include the evaluation of psychological symptoms, functioning, well-being, treatment acceptability and indicators of intervention cost-effectiveness.
ETHICS AND DISSEMINATION


The two trials received ethical clearance from the local Ethics Committees of the participating sites (seven sites), as well as from the WHO Ethics Committee. All participants will provide informed consent before screening and before study inclusion (a two-step procedure). The results of the trials will be disseminated in agreement with a dissemination plan that includes publication(s) in peer-reviewed journals and presentations at relevant national and international conferences and meetings.
TRIALS REGISTRATION NUMBERS


NCT03571347, NCT03587896.",2019,"In these trials SH+ is being tested as a preventative intervention to lower the incidence of mental disorders in asylum seekers and refugees with psychological distress resettled in Europe and Turkey.
","['600 asylum seekers and refugees screening positive on the General Health Questionnaire (≥3), but without a formal diagnosis of any mental disorders according to the Mini International Neuropsychiatric Interview', 'mental disorders in refugees and asylum seekers in Europe and Turkey']","['Self-Help', 'Self-Help Plus (SH', 'Plus (SH']","['evaluation of psychological symptoms, functioning, well-being, treatment acceptability and indicators of intervention cost-effectiveness', 'lower incidence of mental disorders', 'Effectiveness and cost-effectiveness']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1272267', 'cui_str': 'Asylum Seekers'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire (assessment scale)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",600.0,0.142856,"In these trials SH+ is being tested as a preventative intervention to lower the incidence of mental disorders in asylum seekers and refugees with psychological distress resettled in Europe and Turkey.
","[{'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Purgato', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Carswell', 'Affiliation': 'Department of Mental Health & Substance Abuse, World Health Organisation, Geneve, Switzerland.'}, {'ForeName': 'Ceren', 'Initials': 'C', 'LastName': 'Acarturk', 'Affiliation': 'Istanbul Sehir Universitesi, Istanbul, Turkey.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Au', 'Affiliation': 'Department of Mental Health & Substance Abuse, World Health Organisation, Geneve, Switzerland.'}, {'ForeName': 'Sena', 'Initials': 'S', 'LastName': 'Akbai', 'Affiliation': 'Department of Psychology, Istanbul Sehir Universitesi, Istanbul, Turkey.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Anttila', 'Affiliation': 'Department of Nursing Science, University of Turku, Turku, Finland.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Baumgartner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Bailey', 'Affiliation': 'Health Sciences, University of York, York, UK.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Biondi', 'Affiliation': 'Department of Human Neurosciences, University of Rome La Sapienza, Roma, Lazio, Italy.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Bird', 'Affiliation': 'IFRC Reference Centre for Psychosocial Support, Danish Red Cross, Copenhagen, Denmark.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Churchill', 'Affiliation': 'University of York, York, UK.'}, {'ForeName': 'Sevde', 'Initials': 'S', 'LastName': 'Eskici', 'Affiliation': 'Department of Psychology, Istanbul Sehir Universitesi, Istanbul, Turkey.'}, {'ForeName': 'Louise Juul', 'Initials': 'LJ', 'LastName': 'Hansen', 'Affiliation': 'IFRC Reference Centre for Psychosocial Support, Danish Red Cross, Copenhagen, Denmark.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Heron', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Ilkkursun', 'Affiliation': 'Department of Psychology, Istanbul Sehir Universitesi, Istanbul, Turkey.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Kilian', 'Affiliation': 'Department of Psychiatry II, Ulm University, Ulm, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Koesters', 'Affiliation': 'Cochrane Global Mental Health, Verona, Italy.'}, {'ForeName': 'Tella', 'Initials': 'T', 'LastName': 'Lantta', 'Affiliation': 'Department of Nursing Science, Turun Yliopisto, Turku, Finland.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Nosè', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Ostuzzi', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Papola', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Popa', 'Affiliation': 'Institute of Life and Human Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Sijbrandij', 'Affiliation': 'Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Tarsitani', 'Affiliation': 'Department of Human Neurosciences, University of Rome La Sapienza, Roma, Lazio, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Tedeschi', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Turrini', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Uygun', 'Affiliation': 'Trauma and Disaster Mental Health, Istanbul Bilgi Universitesi, Istanbul, Turkey.'}, {'ForeName': 'Maritta Anneli', 'Initials': 'MA', 'LastName': 'Välimäki', 'Affiliation': 'Department of Nursing Science, University of Turku, Turku, Finland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Wancata', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Division of Social Psychiatry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'White', 'Affiliation': 'Institute of Life and Human Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Zanini', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical Psychology, VU University Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Barbui', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Van Ommeren', 'Affiliation': 'Department of Mental Health and Substance Dependence, World Health Organisation, Geneva, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2019-030259']
1006,31110097,Evaluating NHS Stop Smoking Service engagement in community pharmacies using simulated smokers: fidelity assessment of a theory-based intervention.,"OBJECTIVES


Smokers are more likely to quit if they use the National Health Service (NHS) Stop Smoking Service (SSS). However, community pharmacies experience low service uptake. The Smoking Treatment Optimisation in Pharmacies (STOP) programme aims to address this problem by enhancing staff training using a theory-based intervention. In this study, we evaluated intervention fidelity using simulated smokers (actors) to assess smoker engagement and enactment of key intervention components by STOP trained staff.
DESIGN


An observational pilot study.
SETTINGS


Five community pharmacies in North East London with an NHS SSS.
METHODS


Six actors, representative of East London's population, were recruited and trained to complete intervention fidelity assessments. Consenting pharmacy staff from five participating pharmacies received STOP Intervention training. Four weeks after the staff training, the actors visited the participating pharmacies posing as smokers eligible for smoking cessation support. Engagement behaviour by pharmacy staff and enactment of intervention components was assessed using a scoring tool derived from the STOP logic model (scoring range of 0-36), and contemporaneous field notes taken by actors.
RESULTS


18 of 30 completed assessments were with STOP trained staff (10/18 were counter assistants). Mean score for smoker engagement was 24.4 (SD 9.0) points for trained and 16.9 (SD 7.8) for untrained staff, respectively. NHS SSS leaflets (27/30) were the most common smoking cessation materials seen on pharmacy visits. Most trained counter staff engaged with smokers using leaflets and a few proactively offered appointments with their cessation advisors. Appropriate use of body language was reported on 26/30 occasions alongside the use of key phrases from the STOP training session (n=8). Very few pharmacy staff wore STOP promotional badges (4/30).
CONCLUSIONS


STOP training may change client engagement behaviour in pharmacy staff and could improve the uptake of the NHS SSS. A cluster randomised controlled trial is currently in progress to evaluate its effectiveness and cost-effectiveness.
TRIAL REGISTRATION NUMBER


ISRCTN16351033.",2019,"Mean score for smoker engagement was 24.4 (SD 9.0) points for trained and 16.9 (SD 7.8) for untrained staff, respectively.","['18 of 30 completed assessments were with STOP trained staff (10/18 were counter assistants', ""Six actors, representative of East London's population"", 'Five community pharmacies in North East London with an NHS SSS', 'Consenting pharmacy staff from five participating pharmacies received', 'community pharmacies using simulated smokers']","['STOP Intervention training', 'STOP training']",['Mean score for smoker engagement'],"[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0335083', 'cui_str': 'Actor (occupation)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",,0.0632027,"Mean score for smoker engagement was 24.4 (SD 9.0) points for trained and 16.9 (SD 7.8) for untrained staff, respectively.","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Jumbe', 'Affiliation': 'Centre for Primary Care and Public Health, Barts and The London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Wai Y', 'Initials': 'WY', 'LastName': 'James', 'Affiliation': 'Centre for Primary Care and Public Health, Barts and The London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Vichithranie', 'Initials': 'V', 'LastName': 'Madurasinghe', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Steed', 'Affiliation': 'Centre for Primary Care and Public Health, Barts and The London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Ratna', 'Initials': 'R', 'LastName': 'Sohanpal', 'Affiliation': 'Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Tammy K', 'Initials': 'TK', 'LastName': 'Yau', 'Affiliation': 'Department of Medicine, California Northstate University, Elk Grove, California, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Eldridge', 'Affiliation': 'Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Griffiths', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Walton', 'Affiliation': 'Centre for Health Sciences, Barts and The London School of Medicine and Dentistry, London, UK.'}]",BMJ open,['10.1136/bmjopen-2018-026841']
1007,31110103,"Process evaluation protocol for a cluster randomised trial of a complex, nurse-led intervention to improve hypertension management in India.","INTRODUCTION


India has high prevalence of hypertension but low awareness, treatment and control rate. A cluster randomised trial entitled 'm-Power Heart Project' is being implemented to test the effectiveness of a nurse care coordinator (NCC) led complex intervention to address uncontrolled hypertension in the community health centres (CHCs). The trial's process evaluation will assess the fidelity and quality of implementation, clarify the causal mechanisms and identify the contextual factors associated with variation in the outcomes. The trial will use a theory-based mixed-methods process evaluation, guided by the Consolidated Framework for Implementation Research.
METHODS AND ANALYSIS


The process evaluation will be conducted in the CHCs of Visakhapatnam (southern India). The key stakeholders involved in the intervention development and implementation will be included as participants. In-depth interviews will be conducted with intervention developers, doctors, NCCs and health department officials and focus groups with patients and their caregivers. NCC training will be evaluated using Kirkpatrick's model for training evaluation. Key process evaluation indicators (number of patients recruited and retained; concordance between the treatment plans generated by the electronic decision support system and treatment prescribed by the doctor and so on) will be assessed. Fidelity will be assessed using Borrelli  et al 's framework. Qualitative data will be analysed using the template analysis technique. Quantitative data will be summarised as medians (IQR), means (SD) and proportions as appropriate. Mixed-methods analysis will be conducted to assess if the variation in the mean reduction of systolic blood pressure between the intervention CHCs is influenced by patient satisfaction, training outcome, attitude of doctors, patients and NCCs about the intervention, process indicators etc. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the ethics committees at Public Health Foundation of India and Deakin University. Findings will be disseminated via peer-reviewed publications, national and international conference presentations.
TRIAL REGISTRATION NUMBER


NCT03164317; Pre-results.",2019,A cluster randomised trial entitled 'm-Power Heart Project' is being implemented to test the effectiveness of a nurse care coordinator (NCC) led complex intervention to address uncontrolled hypertension in the community health centres (CHCs).,['hypertension management in India'],"['NCC training', 'nurse care coordinator (NCC) led complex intervention', 'complex, nurse-led intervention']",['systolic blood pressure'],"[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C4708569', 'cui_str': 'Care coordinator'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.133388,A cluster randomised trial entitled 'm-Power Heart Project' is being implemented to test the effectiveness of a nurse care coordinator (NCC) led complex intervention to address uncontrolled hypertension in the community health centres (CHCs).,"[{'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Srinivasapura Venkateshmurthy', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mc Namara', 'Affiliation': 'School of Medicine, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Koorts', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Sailesh', 'Initials': 'S', 'LastName': 'Mohan', 'Affiliation': 'Centre for Chronic Conditions and Injuries, Public Health Foundation of India, Gurgaon, Haryana, India.'}, {'ForeName': 'Vamadevan', 'Initials': 'V', 'LastName': 'S Ajay', 'Affiliation': 'Centre for Chronic Disease Control, New Delhi, Delhi, India.'}, {'ForeName': 'Devraj', 'Initials': 'D', 'LastName': 'Jindal', 'Affiliation': 'Centre for Chronic Disease Control, New Delhi, Delhi, India.'}, {'ForeName': 'Bhaskara Rao', 'Initials': 'BR', 'LastName': 'Malipeddi', 'Affiliation': 'Interventional Cardiology, KIMS ICON Hospital, Visakhapatnam, Andhra Pradesh, India.'}, {'ForeName': 'Ambuj', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences, New Delhi, Delhi, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, Delhi, India.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Centre for Chronic Conditions and Injuries, Public Health Foundation of India, Gurgaon, Haryana, India.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Worsley', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Maddison', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Sharleen', 'Initials': 'S', 'LastName': ""O'Reilly"", 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-027841']
1008,31116355,Effect of the PCSK9 Inhibitor Evolocumab on Total Cardiovascular Events in Patients With Cardiovascular Disease: A Prespecified Analysis From the FOURIER Trial.,"Importance


The PCSK9 inhibitor evolocumab reduced low-density lipoprotein cholesterol and first cardiovascular events in the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, but patients remain at high risk of recurrent cardiovascular events.
Objective


To evaluate the effect of evolocumab on total cardiovascular events, given the importance of total number of cardiovascular events to patients, clinicians, and health economists.
Design, Setting, and Participants


Secondary analysis of a randomized, double-blind clinical trial. The FOURIER trial compared evolocumab or matching placebo and followed up patients for a median of 2.2 years. The study included 27 564 patients with stable atherosclerotic disease receiving statin therapy. Data were analyzed between May 2017 and February 2019.
Main Outcomes and Measures


The primary end point (PEP) was time to first cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization; the key secondary end point was time to first cardiovascular death, myocardial infarction, or stroke. In a prespecified analysis, total cardiovascular events were evaluated between treatment arms.
Results


The mean age of patients was 63 years, 69% of patients were taking high-intensity statin therapy, and the median LDL-C at baseline was 92 mg/dL (to convert to millimoles per liter, multiply by 0.0259). There were 2907 first PEP events and 4906 total PEP events during the trial. Evolocumab reduced total PEP events by 18% (incidence rate ratio [RR], 0.82; 95% CI, 0.75-0.90; P < .001) including both first events (hazard ratio, 0.85; 95% CI, 0.79-0.92; P < .001) and subsequent events (RR, 0.74; 95% CI, 0.65-0.85). There were 2192 total primary events in the evolocumab group and 2714 total events in the placebo group. For every 1000 patients treated for 3 years, evolocumab prevented 22 first PEP events and 52 total PEP events. Reductions in total events were driven by fewer total myocardial infarctions (RR, 0.74; 95% CI, 0.65-0.84; P < .001), strokes (RR, 0.77; 95% CI, 0.64-0.93; P = .007), and coronary revascularizations (RR, 0.78; 95% CI, 0.71-0.87; P < .001).
Conclusions and Relevance


The addition of the PCSK9 inhibitor evolocumab to statin therapy improved clinical outcomes, with significant reductions in total PEP events, driven by decreases in myocardial infarction, stroke, and coronary revascularization. More than double the number of events were prevented with evolocumab vs placebo as compared with the analysis of only first events. These data provide further support for the benefit of continuing aggressive lipid-lowering therapy to prevent recurrent cardiovascular events.
Trial Registration


ClinicalTrials.gov identifier: NCT01764633.",2019,"Evolocumab reduced total PEP events by 18% (incidence rate ratio [RR], 0.82; 95% CI, 0.75-0.90; P < .001) including both first events (hazard ratio, 0.85; 95% CI, 0.79-0.92; P < .001) and subsequent events (RR, 0.74; 95% CI, 0.65-0.85).","['27\u202f564 patients with stable atherosclerotic disease receiving statin therapy', 'Patients With Cardiovascular Disease']","['placebo', 'evolocumab or matching placebo', 'evolocumab', 'PCSK9 Inhibitor Evolocumab', 'evolocumab vs placebo']","['strokes', 'total events', 'total myocardial infarctions', 'total PEP events', 'total cardiovascular events', 'coronary revascularizations', '4906 total PEP events', 'Total Cardiovascular Events', 'low-density lipoprotein cholesterol and first cardiovascular events', 'time to first cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization; the key secondary end point was time to first cardiovascular death, myocardial infarction, or stroke', 'myocardial infarction, stroke, and coronary revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4522007', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 inhibitor'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]",27564.0,0.375442,"Evolocumab reduced total PEP events by 18% (incidence rate ratio [RR], 0.82; 95% CI, 0.75-0.90; P < .001) including both first events (hazard ratio, 0.85; 95% CI, 0.79-0.92; P < .001) and subsequent events (RR, 0.74; 95% CI, 0.65-0.85).","[{'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}, {'ForeName': 'Terje R', 'Initials': 'TR', 'LastName': 'Pedersen', 'Affiliation': 'Oslo University Hospital, Ullevål and Medical Faculty, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Zbigniew A', 'Initials': 'ZA', 'LastName': 'Gaciong', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Diseases, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ceska', 'Affiliation': 'Center for Preventive Cardiology, 3rd Internal Medicine Clinic, University General Hospital and Charles University 1st Medical Faculty, Prague, Czech Republic.'}, {'ForeName': 'Marat V', 'Initials': 'MV', 'LastName': 'Ezhov', 'Affiliation': 'National Cardiology Research Center, Moscow, Russia.'}, {'ForeName': 'Derek L', 'Initials': 'DL', 'LastName': 'Connolly', 'Affiliation': 'Birmingham City and Sandwell Hospitals and the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, England.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Kalman', 'Initials': 'K', 'LastName': 'Toth', 'Affiliation': 'First Department of Medicine, University of Pecs, Medical School, Pecs, Hungary.'}, {'ForeName': 'Matti J', 'Initials': 'MJ', 'LastName': 'Tikkanen', 'Affiliation': 'Folkhälsan Research Center, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kyungah', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kurtz', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Narimon', 'Initials': 'N', 'LastName': 'Honarpour', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'Sydney Medical School, National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sever', 'Affiliation': 'Imperial College London, London, England.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Masschusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2019.0886']
1009,31067138,"Local Consolidative Therapy Vs. Maintenance Therapy or Observation for Patients With Oligometastatic Non-Small-Cell Lung Cancer: Long-Term Results of a Multi-Institutional, Phase II, Randomized Study.","PURPOSE


Our previously published findings reported that local consolidative therapy (LCT) with radiotherapy or surgery improved progression-free survival (PFS) and delayed new disease in patients with oligometastatic non-small-cell lung cancer (NSCLC) that did not progress after front-line systemic therapy. Herein, we present the longer-term overall survival (OS) results accompanied by additional secondary end points.
PATIENTS AND METHODS


This multicenter, randomized, phase II trial enrolled patients with stage IV NSCLC, three or fewer metastases, and no progression at 3 or more months after front-line systemic therapy. Patients were randomly assigned (1:1) to maintenance therapy or observation (MT/O) or to LCT to all active disease sites. The primary end point was PFS; secondary end points were OS, toxicity, and the appearance of new lesions. All analyses were two sided, and  P  values less than .10 were deemed significant.
RESULTS


The Data Safety and Monitoring Board recommended early trial closure after 49 patients were randomly assigned because of a significant PFS benefit in the LCT arm. With an updated median follow-up time of 38.8 months (range, 28.3 to 61.4 months), the PFS benefit was durable (median, 14.2 months [95% CI, 7.4 to 23.1 months] with LCT  v  4.4 months [95% CI, 2.2 to 8.3 months] with MT/O;  P  = .022). We also found an OS benefit in the LCT arm (median, 41.2 months [95% CI, 18.9 months to not reached] with LCT  v  17.0 months [95% CI, 10.1 to 39.8 months] with MT/O;  P  = .017). No additional grade 3 or greater toxicities were observed. Survival after progression was longer in the LCT group (37.6 months with LCT  v  9.4 months with MT/O;  P  = .034). Of the 20 patients who experienced progression in the MT/O arm, nine received LCT to all lesions after progression, and the median OS was 17 months (95% CI, 7.8 months to not reached).
CONCLUSION


In patients with oligometastatic NSCLC that did not progress after front-line systemic therapy, LCT prolonged PFS and OS relative to MT/O.",2019,Survival after progression was longer in the LCT group (37.6 months with LCT  v  9.4 months with MT/O;  P  = .034).,"['patients with oligometastatic non-small-cell lung cancer (NSCLC', '49 patients', 'Patients With Oligometastatic Non-Small-Cell Lung Cancer', 'enrolled patients with stage IV NSCLC, three or fewer metastases, and no progression at 3 or more months after front-line systemic therapy']","['maintenance therapy or observation (MT/O) or to LCT', 'LCT', 'Maintenance Therapy or Observation', 'local consolidative therapy (LCT) with radiotherapy']","['OS benefit', 'Survival after progression', 'progression-free survival (PFS', 'OS, toxicity, and the appearance of new lesions', 'longer-term overall survival (OS', 'median OS', 'PFS benefit', 'toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",49.0,0.136817,Survival after progression was longer in the LCT group (37.6 months with LCT  v  9.4 months with MT/O;  P  = .034).,"[{'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Gomez', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Blumenschein', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Hernandez', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'J Jack', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Ye', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': '2 London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Louie', 'Affiliation': '2 London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'D Ross', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': '3 University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Doebele', 'Affiliation': '3 University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Ferdinandos', 'Initials': 'F', 'LastName': 'Skoulidis', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Laurie E', 'Initials': 'LE', 'LastName': 'Gaspar', 'Affiliation': '3 University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Welsh', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Don L', 'Initials': 'DL', 'LastName': 'Gibbons', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Karam', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kavanagh', 'Affiliation': '3 University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Tsao', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Sepesi', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Swisher', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Heymach', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00201']
1010,31646767,Population Pharmacokinetic/Pharmacodynamic Modeling of Methylprednisolone in Neonates Undergoing Cardiopulmonary Bypass.,"Methylprednisolone is used in neonates to modulate cardiopulmonary bypass (CPB)-induced inflammation, but optimal dosing and exposure are unknown. We used plasma methylprednisolone and interleukin (IL)-6 and IL-10 concentrations from neonates enrolled in a randomized trial comparing one vs. two doses of methylprednisolone to develop indirect response population pharmacokinetic/pharmacodynamic models characterizing the exposure-response relationships. We applied the models to simulate methylprednisolone dosages resulting in the desired IL-6 and -10 exposures, known mediators of CPB-induced inflammation. A total of 64 neonates (median weight 3.2 kg, range 2.2-4.3) contributed 290 plasma methylprednisolone concentrations (range 1.07-12,700 ng/mL) and IL-6 (0-681 pg/mL) and IL-10 (0.1-1125 pg/mL). Methylprednisolone plasma exposure following a single 10 mg/kg intravenous dose inhibited IL-6 and stimulated IL-10 production when compared with placebo. Higher (30 mg/kg) or more frequent (twice) dosing did not confer additional benefit. Clinical efficacy studies are needed to evaluate the effect of optimized dosing on outcomes.",2019,Higher (30 mg/kg) or more frequent (twice) dosing did not confer additional benefit.,"['Neonates Undergoing Cardiopulmonary Bypass', '64 neonates (median weight 3.2\xa0kg, range 2.2-4.3) contributed 290 plasma methylprednisolone concentrations (range 1.07-12,700\xa0ng/mL) and IL-6 (0-681\xa0pg/mL) and IL-10 (0.1-1125\xa0pg/mL']","['plasma methylprednisolone and interleukin (IL)-6 and IL-10 concentrations', 'placebo', 'Methylprednisolone', 'methylprednisolone']",['IL-6 and stimulated IL-10 production'],"[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0033268'}]",,0.235628,Higher (30 mg/kg) or more frequent (twice) dosing did not confer additional benefit.,"[{'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, University of North Carolina Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dumond', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, University of North Carolina Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Huali', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Graham', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohen-Wolkowiez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12470']
1011,31429802,An online alcohol and risky sex prevention program for college students studying abroad: study protocol for a randomized controlled trial.,"BACKGROUND


This study protocol describes a proposed randomized controlled trial that builds upon a successful pilot intervention study to address problematic and dangerous drinking among young adult college students studying abroad in foreign environments. Despite universities and colleges citing alcohol misuse as the most concerning issue for their students abroad, most institutions offer no empirically-based prevention efforts tailored to this at-risk population. The proposed intervention attempts to fill a major gap for the nearly 333,000 students completing study abroad programs each year by using empirically-based and theoretically-informed risk and protective factors to correct misperceived peer drinking norms and promote cultural engagement abroad. In addition to preventing heavy and problematic drinking, the intervention seeks to prevent risky sexual behaviors (e.g., sex without a condom) and experience of sexual violence victimization, which are strikingly common among study abroad students and have the potential for lasting physical and psychological effects upon return home.
METHODS/DESIGN


We will conduct a randomized controlled trial of an intervention with a sample of 1200 college students studying abroad from approximately 50 US universities and colleges. The brief, online intervention is text and video based and contains evidence-based components of personalized normative feedback to correct students' misperceived drinking norms, content to promote engagement with the cultural experience abroad and address difficulties adjusting to life in the foreign environment, and tips and strategies to prevent risky sexual behaviors and sexual violence victimization abroad. Participants will complete online surveys at five time points (predeparture, first month abroad, last month abroad, 1-month post-return, and 3-months post-return) to assess for intervention effects on drinking behavior, drinking consequences, risky sex, and sexual violence outcomes. We will examine whether the mechanisms targeted by the intervention (changes in perceived norms, engagement in the cultural experience abroad) serve as mediators of intervention efficacy.
DISCUSSION


The proposed study has the potential to fill an important gap in the research literature and provide empirical support for an online accessible, brief, and targeted approach that can easily be distributed to study abroad students to help prevent heavy alcohol use and sexual risk abroad. Trial registration ClinicalTrials.gov Identifier NCT03928067.",2019,"We will examine whether the mechanisms targeted by the intervention (changes in perceived norms, engagement in the cultural experience abroad) serve as mediators of intervention efficacy.
","['young adult college students studying abroad in foreign environments', '1200 college students studying abroad from approximately 50 US universities and colleges', 'college students studying abroad']",['online alcohol and risky sex prevention program'],"['drinking behavior, drinking consequences, risky sex, and sexual violence outcomes', 'risky sexual behaviors']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0013124', 'cui_str': 'Drinking Behavior'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",1200.0,0.0478739,"We will examine whether the mechanisms targeted by the intervention (changes in perceived norms, engagement in the cultural experience abroad) serve as mediators of intervention efficacy.
","[{'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Pedersen', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2138, Santa Monica, CA, 90407-2138, USA. ericp@rand.org.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': ""D'Amico"", 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'LaBrie', 'Affiliation': 'Department of Psychology, Loyola Marymount University, 1 LMU Drive, Los Angeles, CA, 90045, USA.'}, {'ForeName': 'Coreen', 'Initials': 'C', 'LastName': 'Farris', 'Affiliation': 'RAND Corporation, 4570 Fifth Ave, Ste. #600, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Klein', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Beth Ann', 'Initials': 'BA', 'LastName': 'Griffin', 'Affiliation': 'RAND Corporation, 1200 South Hayes Street, Arlington, VA, 22202, USA.'}]",Addiction science & clinical practice,['10.1186/s13722-019-0162-4']
1012,30932154,Do graphic health warning labels on cigarette packages deter purchases at point-of-sale? An experiment with adult smokers.,"This experiment tested whether the presence of graphic health warning labels on cigarette packages deterred adult smokers from purchasing cigarettes at retail point-of-sale (POS), and whether individual difference variables moderated this relationship. The study was conducted in the RAND StoreLab (RSL), a life-sized replica of a convenience store that was developed to evaluate how changing POS tobacco advertising influences tobacco use outcomes during simulated shopping experiences. Adult smokers (n = 294; 65% female; 59% African-American; 35% White) were assigned randomly to shop in the RSL under one of two experimental conditions: graphic health warning labels present on cigarette packages versus absent on cigarette packages. Cigarette packages in both conditions were displayed on a tobacco power wall, which was located behind the RSL cashier counter. Results revealed that the presence of graphic health warning labels did not influence participants' purchase of cigarettes as a main effect. However, nicotine dependence acted as a significant moderator of experimental condition. Graphic health warning labels reduced the chances of cigarette purchases for smokers lower in nicotine dependence but had no effect on smokers higher in dependence.",2019,Graphic health warning labels reduced the chances of cigarette purchases for smokers lower in nicotine dependence but had no effect on smokers higher in dependence.,"['cigarette packages deterred adult smokers from purchasing cigarettes at retail point-of-sale (POS', 'adult smokers', 'Adult smokers (n = 294; 65% female; 59% African-American; 35% White']","['graphic health warning labels', 'graphic health warning labels present on cigarette packages versus absent on cigarette packages']",[],"[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}]",[],294.0,0.0191404,Graphic health warning labels reduced the chances of cigarette purchases for smokers lower in nicotine dependence but had no effect on smokers higher in dependence.,"[{'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Shadel', 'Affiliation': 'RAND Corporation, 4570 Fifth Ave., Suite 600, Pittsburgh, PA, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Martino', 'Affiliation': 'RAND Corporation, 4570 Fifth Ave., Suite 600, Pittsburgh, PA, USA.'}, {'ForeName': 'Claude M', 'Initials': 'CM', 'LastName': 'Setodji', 'Affiliation': 'RAND Corporation, 4570 Fifth Ave., Suite 600, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dunbar', 'Affiliation': 'RAND Corporation, 4570 Fifth Ave., Suite 600, Pittsburgh, PA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Scharf', 'Affiliation': 'Department of Psychology, Lakehead University, 955 Oliver Rd., Thunder Bay, Ontario, Canada.'}, {'ForeName': 'Kasey G', 'Initials': 'KG', 'LastName': 'Creswell', 'Affiliation': 'Department of Psychology, Carnegie Mellon University, 5000 Forbes Ave.,Pittsburgh, PA, USA.'}]",Health education research,['10.1093/her/cyz011']
1013,31665727,Toward Preventing Enamel Hypoplasia: Modeling Maternal and Neonatal Biomarkers of Human Calcium Homeostasis.,"AIM


The aim of this study was to assess biomarkers of calcium homeostasis and tooth development, in mothers during pregnancy and their children at birth, for enamel hypoplasia (EH) in the primary maxillary central incisor teeth.
METHODS


Bayesian methodology was used for secondary data analyses from a randomized, controlled trial of prenatal vitamin D3 supplementation in healthy mothers (N = 350) and a follow-up study of a subset of the children. The biomarkers were serum calcium (Ca), phosphorus (P), intact parathyroid hormone (iPTH), total circulating 25-dihydroxyvitamin D (25(OH)D), and 1,25-dihydroxyvitamin D (1,25(OH)2D). The maternal biomarkers were assayed monthly during pregnancy, and the child's biomarkers were derived from cord blood. Digital images of the child's 2 teeth were scored for EH using Enamel Defects Index criteria for each of the incisal, middle, and cervical regions for an EH extent score.
RESULTS


The child EH prevalence was 41% (60/145), with most defects present in the incisal and middle tooth regions. Cord blood iPTH and 1,25(OH)2D levels were significantly associated with EH extent after controlling for maternal factors. For every 1 pg/mL increase in cord blood iPTH, the EH extent decreased by approximately 6%. For every 10 pg/mL increase in cord blood 1,25(OH)2D, the EH extent increased by almost 30% (holding all other terms constant and adjusting for subject-level heterogeneity). The relationship between maternal 25(OH)D and maternal mean iPTH varied significantly by EH extent.
CONCLUSION


The results suggest possible modifiable relationships of maternal and neonatal factors of calcium homeostasis during pregnancy and at birth for EH, contributing to the frontier of knowledge regarding sound tooth development for dental caries prevention.",2020,"Cord blood iPTH and 1,25(OH)2D levels were significantly associated with EH extent after controlling for maternal factors.","['mothers during pregnancy and their children at birth, for enamel hypoplasia (EH) in the primary maxillary central incisor teeth', 'healthy mothers (N = 350) and a follow-up study of a subset of the children']",['prenatal vitamin D3 supplementation'],"['serum calcium (Ca), phosphorus (P), intact parathyroid hormone (iPTH), total circulating 25-dihydroxyvitamin D (25(OH)D), and 1,25-dihydroxyvitamin D (1,25(OH)2D', 'cord blood 1,25(OH)2D, the EH extent', 'cord blood iPTH, the EH extent', 'child EH prevalence', 'Cord blood iPTH and 1,25(OH)2D levels', 'maternal 25(OH)D and maternal mean iPTH']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0011351', 'cui_str': 'Enamel Hypoplasia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}]","[{'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0012328', 'cui_str': 'Dihydroxyvitamins D'}, {'cui': 'C0370232', 'cui_str': '1,25-dihydroxyvitamin D'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",350.0,0.0416406,"Cord blood iPTH and 1,25(OH)2D levels were significantly associated with EH extent after controlling for maternal factors.","[{'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Reed', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA, reedsg@musc.edu.'}, {'ForeName': 'Cameron S', 'Initials': 'CS', 'LastName': 'Miller', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Wagner', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Lawson', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}]",Caries research,['10.1159/000502793']
1014,31443663,The effect of a clinical decision support system on prompting an intervention for risky alcohol use in a primary care smoking cessation program: a cluster randomized trial.,"BACKGROUND


Clinical decision support systems (CDSSs) may promote practitioner adherence to evidence-based guidelines. This study examined if the addition of a CDSS influenced practitioner delivery of a brief intervention with treatment-seeking smokers who were drinking above recommended alcohol consumption guidelines, compared with practitioners who do not receive a CDSS prompt.
METHODS


This was a cluster randomized controlled trial conducted in primary health care clinics across Ontario, Canada, implementing the Smoking Treatment for Ontario Patients (STOP) smoking cessation program. Clinics randomized to the intervention group received a prompt when a patient reported consuming alcohol above the Canadian Cancer Society (CCS) guidelines; the control group did not receive computer alerts. The primary outcome was an offer of an appropriate educational alcohol resource, an alcohol reduction workbook for patients drinking above the CCS guidelines, and an abstinence workbook to patients scoring above 20 points in the AUDIT screening tool; the secondary outcome was patient acceptance of the resource. The tertiary outcome was patient abstinence from smoking, and alcohol consumption within CCS guidelines, at 6-month follow-up. Results were analyzed using a generalized estimation approach for fitting logistic regression using a population-averaged method.
RESULTS


Two hundred and twenty-one clinics across Ontario were randomized for this study; 110 to the intervention arm and 111 to the control arm. From the 15,222 patients that enrolled in the smoking cessation program, 15,150 (99.6% of patients) were screened for alcohol use and 5715 patients were identified as drinking above the CCS guidelines. No statistically significant difference between groups was seen in practitioner offer of an educational alcohol resource to appropriate patients (OR = 1.19, 95% CI 0.88-1.64, p = 0.261) or in patient abstinence from smoking and drinking within the CCS guidelines at 6-month follow-up (OR = 0.93, 95% CI 0.71-1.22, p = 0.594). However, a significantly greater proportion of patients in the intervention group accepted the alcohol resource offered to them by their practitioner (OR = 1.48, 95% CI 1.01-2.16, p = 0.045).
CONCLUSION


A CDSS may not increase the likelihood of practitioners offering an educational alcohol resource, though it may have influenced patients' acceptance of the resource.
TRIAL REGISTRATION


This trial is registered with ClinicalTrials.gov, number NCT03108144 , registered on April 11, 2017, ""retrospectively registered"".",2019,"No statistically significant difference between groups was seen in practitioner offer of an educational alcohol resource to appropriate patients (OR = 1.19, 95% CI 0.88-1.64, p = 0.261) or in patient abstinence from smoking and drinking within the CCS guidelines at 6-month follow-up (OR = 0.93, 95% CI 0.71-1.22, p = 0.594).","['risky alcohol use in a primary care smoking cessation program', 'primary health care clinics across Ontario, Canada, implementing the Smoking Treatment for Ontario Patients (STOP) smoking cessation program', '15,222 patients that enrolled in the smoking cessation program, 15,150 (99.6% of patients) were screened for alcohol use and 5715 patients were identified as drinking above the CCS guidelines', 'Two hundred and twenty-one clinics across Ontario were randomized for this study; 110 to the intervention arm and 111 to the control arm', 'treatment-seeking smokers who were drinking above recommended alcohol consumption guidelines, compared with practitioners who do not receive a CDSS prompt']","['clinical decision support system', 'prompt when a patient reported consuming alcohol above the Canadian Cancer Society (CCS) guidelines; the control group did not receive computer alerts', 'CDSS']","['educational alcohol resource', 'patient abstinence from smoking, and alcohol consumption', 'appropriate educational alcohol resource, an alcohol reduction workbook for patients drinking above the CCS guidelines, and an abstinence workbook']","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]",221.0,0.0779171,"No statistically significant difference between groups was seen in practitioner offer of an educational alcohol resource to appropriate patients (OR = 1.19, 95% CI 0.88-1.64, p = 0.261) or in patient abstinence from smoking and drinking within the CCS guidelines at 6-month follow-up (OR = 0.93, 95% CI 0.71-1.22, p = 0.594).","[{'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Minian', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, 175 College St, Toronto, ON, M5T1P7, Canada.'}, {'ForeName': 'Dolly', 'Initials': 'D', 'LastName': 'Baliunas', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, 175 College St, Toronto, ON, M5T1P7, Canada.'}, {'ForeName': 'Aliya', 'Initials': 'A', 'LastName': 'Noormohamed', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, 175 College St, Toronto, ON, M5T1P7, Canada.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Zawertailo', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, 175 College St, Toronto, ON, M5T1P7, Canada.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Giesbrecht', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell St, Toronto, ON, M5S 2S1, Canada.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Hendershot', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 60 White Squirrel Way, Toronto, ON, M6J 1H4, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, 500 University Ave, Toronto, ON, M5G 1V7, Canada.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rehm', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, 155 College, Toronto, ON, M5T 3M7, Canada.'}, {'ForeName': 'Andriy V', 'Initials': 'AV', 'LastName': 'Samokhvalov', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell St, Toronto, ON, M5S 2S1, Canada.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Selby', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, 175 College St, Toronto, ON, M5T1P7, Canada. peter.selby@camh.ca.'}]",Implementation science : IS,['10.1186/s13012-019-0935-x']
1015,31446893,Physicians' satisfaction with providing buprenorphine treatment.,"BACKGROUND


Buprenorphine is a critically important treatment for addressing the opioid epidemic, but there are virtually no studies of physicians' job satisfaction with providing buprenorphine. Physicians' job satisfaction has been linked to burnout and turnover as well as patients' adherence to treatment recommendations, so it is important to understand how physicians' satisfaction with providing buprenorphine treatment compares to their overall job satisfaction.
METHODS


As part of a cluster randomized clinical trial (RCT) focused on expanding access to medication for opioid use disorder, 55 physicians working in 38 organizations in Florida, Ohio, and Wisconsin completed a baseline web-based survey. Study measures included global job satisfaction, career satisfaction, and specialty satisfaction. Physicians who were waivered to prescribe buprenorphine were asked to rate their satisfaction with their current buprenorphine practice.
RESULTS


Overall, physicians were generally satisfied with their jobs, their careers, and their specialties. When waivered physicians (n = 40) were compared to non-waivered physicians (n = 15) on 13 satisfaction items, there were no statistically significant differences. Among waivered physicians, ratings for buprenorphine work were significantly lower than ratings for general medical practice for finding such work personally rewarding, being pleased with such work, and overall satisfaction.
CONCLUSIONS


Although waivered and non-waivered physicians both reported high global job satisfaction, these data suggest that some waivered physicians may view their buprenorphine work as somewhat less satisfying than their global medical practice. Given that job dissatisfaction is a risk factor for turnover and burnout, managers of treatment organizations should consider whether strategies may be able to mitigate some sources of lower satisfaction in the context of buprenorphine treatment. Trial registration ClinicalTrials.gov. NCT02926482. Date of registration: September 9, 2016. https://clinicaltrials.gov/ct2/show/NCT02926482.",2019,"Among waivered physicians, ratings for buprenorphine work were significantly lower than ratings for general medical practice for finding such work personally rewarding, being pleased with such work, and overall satisfaction.
","['55 physicians working in 38 organizations in Florida, Ohio, and Wisconsin completed a baseline web-based survey']","['Buprenorphine', 'buprenorphine']","['global job satisfaction, career satisfaction, and specialty satisfaction']","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",38.0,0.0252868,"Among waivered physicians, ratings for buprenorphine work were significantly lower than ratings for general medical practice for finding such work personally rewarding, being pleased with such work, and overall satisfaction.
","[{'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'Knudsen', 'Affiliation': 'Department of Behavioral Science and Center on Drug and Alcohol Research, University of Kentucky, 845 Angliana Ave., Room 204, Lexington, KY, 40508, USA. hannah.knudsen@uky.edu.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, 1100 Delaplaine Ct., Madison, WI, 53715-1896, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Jacobson', 'Affiliation': 'Institute for Clinical and Translational Research, University of Wisconsin-Madison, 4116 Signe Skott Cooper Hall, 701 Highland Ave., Madison, WI, 53705, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Horst', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave., Madison, WI, 53706, USA.'}, {'ForeName': 'Jee-Seon', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': ', 1067 Educational Sciences, 1025 West Johnson St., Madison, WI, 53706-1706, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Collier', 'Affiliation': ', 1 West Wilson St. Rm 850, Madison, WI, 53703, USA.'}, {'ForeName': 'Sanford', 'Initials': 'S', 'LastName': 'Starr', 'Affiliation': 'Ohio Department of Mental Health and Addiction Services, 30 E. Broad St., 8th Floor, Columbus, OH, 43215, USA.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Madden', 'Affiliation': 'APT Foundation, 1 Long Wharf Drive, Suite 321, New Haven, CT, 06511, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Haram', 'Affiliation': 'Haram Consulting, 413 River Road, Bowdoinham, ME, 04008, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Toy', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave., Madison, WI, 53706, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Molfenter', 'Affiliation': 'Department of Industrial and Systems Engineering, University of Wisconsin-Madison, 1513 University Ave., Madison, WI, 53706, USA.'}]",Addiction science & clinical practice,['10.1186/s13722-019-0163-3']
1016,31132795,"Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine.","Lasmiditan, a serotonin 5-HT1F receptor agonist, was effective for acute treatment of patients with migraine in a phase 3 double-blind randomized controlled study. The current study was designed to replicate these findings in a generalizable population of patients with migraine, including those with a cardiovascular medical history. This prospective, double-blind, phase 3 multicentre study randomly assigned patients with migraine with and without aura (1:1:1:1 ratio) to oral lasmiditan 200 mg, 100 mg, 50 mg, or placebo. Patients were instructed to dose at home within 4 h of onset of migraine attack of at least moderate intensity and not improving. The primary objective was to assess the proportion of patients' headache pain-free and most bothersome symptom-free at 2 h post-dose for each dose of lasmiditan versus placebo (NCT02605174). Patients (n = 3005) were assigned and treated (n = 2583, safety population): 1938 lasmiditan (200 mg n = 528, 100 mg n = 532, and 50 mg n = 556 included in primary analysis) and 645 placebo (540 included in primary analysis). Most patients (79.2%) had ≥1 cardiovascular risk factor at baseline, in addition to migraine. Lasmiditan was associated with significantly more pain freedom at 2 h (lasmiditan 200 mg: 38.8%, odds ratio 2.3, 95% confidence interval 1.8-3.1, P < 0.001; 100 mg: 31.4%, odds ratio 1.7, 1.3-2.2, P < 0.001; 50 mg: 28.6%, odds ratio 1.5, 1.1-1.9, P = 0.003 versus placebo 21.3%) and freedom from most bothersome symptom at 2 h (lasmiditan 200 mg: 48.7%, odds ratio 1.9, 95% confidence interval 1.4-2.4, P < 0.001; 100 mg: 44.2%, odds ratio 1.6, 1.2-2.0, P < 0.001; 50 mg: 40.8%, odds ratio 1.4, 1.1-1.8, P = 0.009 versus placebo 33.5%). Treatment-emergent adverse events were reported in 253 of 649 (39.0%), 229 of 635 (36.1%), and 166 of 654 (25.4%) of patients on lasmiditan 200, 100, and 50 mg, respectively, versus 75 of 645 (11.6%) on placebo. Most adverse events were CNS-related and included dizziness, somnolence and paraesthesia. Lasmiditan was effective at 2 h post-dose for acute treatment of migraine at all oral doses tested. Efficacy and safety were consistent with the previous phase 3 study.",2019,"Lasmiditan, a serotonin 5-HT1F receptor agonist, was effective for acute treatment of patients with migraine in a phase 3 double-blind randomized controlled study.","['patients with migraine with and without aura (1:1:1:1 ratio) to', 'Patients (n = 3005) were assigned and treated (n = 2583, safety population): 1938 lasmiditan (200 mg n = 528, 100 mg n = 532, and 50 mg n = 556 included in primary analysis) and 645', 'acute treatment of migraine', 'patients with migraine', 'patients with migraine, including those with a cardiovascular medical history']","['oral lasmiditan 200 mg, 100 mg, 50 mg, or placebo', 'placebo']","[""proportion of patients' headache pain-free and most bothersome symptom-free"", '≥1 cardiovascular risk factor', 'pain freedom', 'Treatment-emergent adverse events', 'Efficacy and safety', 'dizziness, somnolence and paraesthesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}]",3005.0,0.622696,"Lasmiditan, a serotonin 5-HT1F receptor agonist, was effective for acute treatment of patients with migraine in a phase 3 double-blind randomized controlled study.","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital; SLaM Biomedical Research Centre, and King's College London, UK.""}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Wietecha', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ellen B', 'Initials': 'EB', 'LastName': 'Dennehy', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Bernice', 'Initials': 'B', 'LastName': 'Kuca', 'Affiliation': 'CoLucid Pharmaceuticals, Inc., a wholly owned subsidiary of Eli Lilly and Company, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Case', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sheena K', 'Initials': 'SK', 'LastName': 'Aurora', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Charly', 'Initials': 'C', 'LastName': 'Gaul', 'Affiliation': 'Migraine and Headache Clinic, Koenigstein im Taunus, Germany.'}]",Brain : a journal of neurology,['10.1093/brain/awz134']
1017,31182536,Tenofovir Plasma Concentration from Preexposure Prophylaxis at the Time of Potential HIV Exposure: a Population Pharmacokinetic Modeling and Simulation Study Involving Serodiscordant Couples in East Africa.,"The Partners Demonstration Project was a prospective, open-label, implementation science-driven study of preexposure prophylaxis (PrEP) among heterosexual HIV serodiscordant couples in Kenya and Uganda. Adherence data were collected using the Medication Event Monitoring System (MEMS), and time of sexual activity was collected using the mobile phone short message service (SMS). Two plasma samples were collected at a single study visit. We integrated adherence, pharmacokinetics, and SMS data using a population pharmacokinetic (PopPK) model to simulate tenofovir plasma concentrations from PrEP at the time of sexual activity. In the first stage of this analysis, we used data from the current study to update a prior PopPK model of tenofovir (TFV) developed with data from the Partners PrEP Study (a phase III clinical trial). The second stage involved simulating plasma concentrations at the time of sexual activity using empirical Bayes estimates (EBEs) derived from the final model. In addition, EBEs from a previously published parent metabolite model of TFV (MTN-001, an open-label 3-way crossover study in healthy women) was used to simulate tenofovir diphosphate (TFV-DP) concentrations. We estimated percent PrEP ""coverage"" as the number of reported sexual events during which simulated concentrations were above an  a priori  threshold concentrations associated with a high degree of protection from HIV infection: plasma TFV of >40 ng/ml and peripheral blood mononuclear cell (PBMC) TFV-DP concentration of >36 fmol/million cells. The levels of coverage were 72% for TFV and 81% for TFV-DP. These levels are consistent with a high degree of protection against HIV acquisition in this study of a pragmatic delivery model for antiretroviral-based HIV prevention.",2019,Percentage coverage was 72% for TFV and 81% for TFV-DP levels.,"['heterosexual HIV serodiscordant couples in Kenya and Uganda', 'serodiscordant couples in East Africa', 'healthy women']","['tenofovir (TFV', 'Tenofovir plasma concentration from pre-exposure prophylaxis (PrEP']","['Percentage coverage', 'time of sexual activity']","[{'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0001741', 'cui_str': 'East Africa'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",,0.0315237,Percentage coverage was 72% for TFV and 81% for TFV-DP levels.,"[{'ForeName': 'Surulivelrajan', 'Initials': 'S', 'LastName': 'Mallayasamy', 'Affiliation': 'UNT System College of Pharmacy, UNT Health Science Center, Fort Worth, Texas, USA.'}, {'ForeName': 'Ayyappa', 'Initials': 'A', 'LastName': 'Chaturvedula', 'Affiliation': 'UNT System College of Pharmacy, UNT Health Science Center, Fort Worth, Texas, USA ayyappa.chaturvedula@unthsc.edu.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'UNT System College of Pharmacy, UNT Health Science Center, Fort Worth, Texas, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sale', 'Affiliation': 'UNT System College of Pharmacy, UNT Health Science Center, Fort Worth, Texas, USA.'}, {'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Goti', 'Affiliation': 'Nuventra, Raleigh, North Carolina, USA.'}, {'ForeName': 'Namandje N', 'Initials': 'NN', 'LastName': 'Bumpus', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00446-19']
1018,30573503,Association of early disease progression and very poor survival in the GALLIUM study in follicular lymphoma: benefit of obinutuzumab in reducing the rate of early progression.,"We evaluated early disease progression and its impact on overall survival (OS) in previously untreated follicular lymphoma patients in GALLIUM ( clinicaltrials.gov identifier: 01332968 ), and investigated the effect on early disease progression of the two randomization arms: obinutuzumab-based  versus  rituximab-based immunochemotherapy. Cause-specific Cox regression was used to estimate the effect of treatment on the risk of disease progression or death due to disease progression within 24 months of randomization and to analyze OS in patients with or without disease progression after 24 months. Mortality in both groups was analyzed 6, 12, and 18 months post randomization (median follow up, 41 months). Fewer early disease progression events occurred in obinutuzumab (57 out of 601)  versus  rituximab (98 out of 601) immunochemotherapy patients, with an average risk reduction of 46.0% (95%CI: 25.0-61.1%; cumulative incidence rate 10.1%  vs  17.4%). At a median post-progression follow up of 22.6 months, risk of mortality increased markedly following a progression event [HR of time-varying progression status, 25.5 (95%CI: 16.2-40.3)]. Mortality risk was higher the earlier patients progressed within the first 24 months. Age-adjusted HR for OS after 24 months in surviving patients with disease progression  versus  those without was 12.2 (95%CI: 5.6-26.5). Post-progression survival was similar by treatment arm. In conclusion, obinutuzumab plus chemotherapy was associated with a marked reduction in the rate of early disease progression events relative to rituximab plus chemotherapy. Early disease progression in patients with follicular lymphoma was associated with poor prognosis, with mortality risk higher after earlier progression. Survival post progression did not seem to be influenced by treatment arm.",2019,"At a median post-progression follow up of 22.6 months, risk of mortality increased markedly following a progression event [HR of time-varying progression status, 25.5 (95%CI: 16.2-40.3)].","['follicular lymphoma', 'patients with follicular lymphoma', 'previously untreated follicular lymphoma patients in GALLIUM ', 'patients with or without disease progression after 24 months']","['obinutuzumab-based  versus  rituximab-based immunochemotherapy', 'obinutuzumab', 'obinutuzumab plus chemotherapy']","['Mortality', 'early disease progression events', 'risk of mortality', 'overall survival (OS', 'Post-progression survival', 'Mortality risk', 'Survival post progression']","[{'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016980', 'cui_str': 'Gallium'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",601.0,0.0303845,"At a median post-progression follow up of 22.6 months, risk of mortality increased markedly following a progression event [HR of time-varying progression status, 25.5 (95%CI: 16.2-40.3)].","[{'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Peter MacCallum Cancer Centre, Royal Melbourne Hospital and University of Melbourne, Victoria, Australia john.seymour@petermac.org.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Marcus', 'Affiliation': 'Kings College Hospital, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': 'Cancer Research UK Centre, University of Southampton, UK.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Gallop-Evans', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Grigg', 'Affiliation': 'Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haynes', 'Affiliation': 'Nottingham University Hospitals NHS Trust, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Herold', 'Affiliation': 'HELIOS-Klinikum Erfurt, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Illmer', 'Affiliation': 'BAG Freiberg-Richter, Jacobasch, Illmer and Wolf, Dresden, Germany.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Nilsson-Ehle', 'Affiliation': 'Section of Hematology and Coagulation, Department of Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sökler', 'Affiliation': 'Eberhard-Karls-University Tübingen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Dünzinger', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Nielsen', 'Affiliation': 'F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Aino', 'Initials': 'A', 'LastName': 'Launonen', 'Affiliation': 'F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': 'Department of Medicine III, Ludwig-Maximilians-University, Munich, Germany.'}]",Haematologica,['10.3324/haematol.2018.209015']
1019,30573506,Mogamulizumab  versus  investigator's choice of chemotherapy regimen in relapsed/refractory adult T-cell leukemia/lymphoma.,"Mogamulizumab, a humanized defucosylated anti-C-C chemokine receptor 4 monoclonal antibody, has been approved in Japan for the treatment of C-C chemokine receptor 4-positive adult T-cell leukemia/lymphoma (ATL). This phase II study evaluated efficacy and safety of mogamulizumab in ATL patients with acute, lymphoma, and chronic subtypes with relapsed/refractory, aggressive disease in the US, Europe, and Latin America. With stratification by subtype, patients were randomized 2:1 to intravenous mogamulizumab 1.0 mg/kg once weekly for 4 weeks and biweekly thereafter (n=47) or investigator's choice of chemotherapy (n=24). The primary end point was confirmed overall response rate (cORR) confirmed on a subsequent assessment at 8 weeks by blinded independent review. ORR was 11% (95%CI: 4-23%) and 0% (95%CI: 0-14%) in the mogamulizumab and chemotherapy arms, respectively. Best response was 28% and 8% in the respective arms. The observed hazard ratio for progression-free survival was 0.71 (95%CI: 0.41-1.21) and, after  post hoc  adjustment for performance status imbalance, 0.57 (95%CI: 0.337-0.983). The most frequent treatment-related adverse (grade ≥3) events with mogamulizumab were infusion-related reaction and thrombocytopenia (each 9%). Relapsed/refractory ATL is an aggressive, poor prognosis disease with a high unmet need. Investigator's choice chemotherapy did not result in tumor response in this trial; however, mogamulizumab treatment resulted in 11% cORR, with a tolerable safety profile.",2019,The observed hazard ratio for progression-free survival was 0.71,"['relapsed/refractory adult T-cell leukemia/lymphoma', 'ATL patients with acute, lymphoma, and chronic subtypes with relapsed/refractory, aggressive disease in the US, Europe, and Latin America']","['intravenous mogamulizumab', 'mogamulizumab', 'Mogamulizumab']","['ORR', 'observed hazard ratio for progression-free survival', 'Best response', 'overall response rate (cORR']","[{'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0023493', 'cui_str': 'ATLL'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2987603', 'cui_str': 'mogamulizumab'}]","[{'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.123375,The observed hazard ratio for progression-free survival was 0.71,"[{'ForeName': 'Adrienne A', 'Initials': 'AA', 'LastName': 'Phillips', 'Affiliation': 'Division of Hematology and Medical Oncology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY, USA adp9002@med.cornell.edu.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Fields', 'Affiliation': ""Department of Haematology Guy's and St Thomas' Hospitals NHS Trust Hospital, London, UK.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Department of Hematology, Necker University Hospital, Paris, France.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Ramos', 'Affiliation': 'Division of Hematology/Oncology, University of Miami Miller School of Medicine, Sylvester Comprehensive Cancer Center, FL, USA.'}, {'ForeName': 'Brady E', 'Initials': 'BE', 'LastName': 'Beltran', 'Affiliation': 'Hospital Nacional Edgardo Rebagliati Martins and Centro de Investigación de Medicina de Precision, Universidad de San Martin de Porres, Lima, Peru.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Pereira', 'Affiliation': 'Department of Hematology, University of São Paulo, Brazil.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Wandroo', 'Affiliation': 'Sandwell and West Birmingham Hospitals NHS Trust, West Bromwich, and University of Birmingham, UK.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Feldman', 'Affiliation': 'John Theurer Cancer Center, Hackensack UMC, NJ, USA.'}, {'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Taylor', 'Affiliation': ""National Centre for Human Retrovirology, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Sawas', 'Affiliation': 'Center for Lymphoid Malignancies, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Humphrey', 'Affiliation': 'Kyowa Kirin, Princeton, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kurman', 'Affiliation': 'Kyowa Kirin, Princeton, NJ, USA.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Moriya', 'Affiliation': 'Kyowa Kirin, Princeton, NJ, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dwyer', 'Affiliation': 'Kyowa Kirin, Princeton, NJ, USA.'}, {'ForeName': 'Mollie', 'Initials': 'M', 'LastName': 'Leoni', 'Affiliation': 'Kyowa Kirin, Princeton, NJ, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Conlon', 'Affiliation': 'Warren Grant Magnuson Clinical Center, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Cook', 'Affiliation': 'Department of Haematology and National Centre for Human Retrovirology, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gonsky', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, New York City Health + Hospitals/Kings County and SUNY Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Horwitz', 'Affiliation': 'Hematology/Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Haematologica,['10.3324/haematol.2018.205096']
1020,31416472,"Comparison of dietary intakes of Canadian Armed Forces personnel consuming field rations in acute hot, cold, and temperate conditions with standardized infantry activities.","BACKGROUND


Dietary Reference Intakes are used to guide the energy intake of the Canadian Armed Forces (CAF) field rations provided to military personnel deployed for training or operations. However, the high energy expenditures likely to occur under harsh environmental/metabolically challenging deployment conditions may not be adequately considered. This study examined the Ad libitum energy and nutrient intakes of CAF personnel (n = 18) consuming field rations in a resting thermoneutral environment and during a day of standardized strenuous infantry activities at varying environmental temperatures.
METHODS


Dietary intake was assessed using a measured food intake/food waste method during the experimental treatment and for 6 h after treatment. Four treatments were administered in a randomized counterbalanced design: exercise (as standardized infantry activities) in the heat (30 °C), exercise in the cold (- 10 °C), exercise in temperate thermoneutral (21 °C) air temperatures and a resting (sedentary) trial (21 °C).
RESULTS


The average Ad libitum consumption of field rations was 70% of the provided total energy (2776 ± 99 kcal/8 h) during all treatments. Even with an acute challenge of increased energy expenditure and temperature stress in the simulated field conditions, participants' energy intakes (1985 ± 747 kcal/8 h) under hot, cold and temperate treatments did not differ from energy intake during the sedentary condition (1920 ± 640 kcal/8 h). Participants' energy intakes (1009 ± 527 kcal/6 h) did not increase during the 6 h posttreatment period when the stresses of the strenuous physical activities and the harsh environmental temperatures had subsided.
CONCLUSION


These results should be considered when planning the provision of field rations for CAF personnel expected to be engaged in strenuous physical activities with prolonged exposure to temperature extremes.",2019,"Participants' energy intakes (1009 ± 527 kcal/6 h) did not increase during the 6 h posttreatment period when the stresses of the strenuous physical activities and the harsh environmental temperatures had subsided.
",[],"['Canadian Armed Forces personnel consuming field rations', 'heat (30\u2009°C), exercise in the cold (-\u200910\u2009°C), exercise in temperate thermoneutral (21\u2009°C) air temperatures and a resting (sedentary) trial (21\u2009°C', 'CAF personnel (n\u2009=\xa018) consuming field rations']",['average Ad libitum consumption of field rations'],[],"[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0440042', 'cui_str': ""Field's""}]",,0.0288236,"Participants' energy intakes (1009 ± 527 kcal/6 h) did not increase during the 6 h posttreatment period when the stresses of the strenuous physical activities and the harsh environmental temperatures had subsided.
","[{'ForeName': 'Mavra', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Science Building, 1 King's College Circle, Room 5368, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Mandic', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, M5S 2W6, Canada.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lou', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, M5T 3M2, Canada.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Goodman', 'Affiliation': 'Defence Research and Development Canada - Toronto Research Centre, Toronto, M3K 2C9, Canada.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, M5S 2W6, Canada.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': ""L'Abbé"", 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Science Building, 1 King's College Circle, Room 5368, Toronto, Ontario, M5S 1A8, Canada. mary.labbe@utoronto.ca.""}]",Military Medical Research,['10.1186/s40779-019-0216-7']
1021,30733182,Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic): a cluster-randomised controlled trial.,"BACKGROUND


Strategies are needed to prevent and control type 2 diabetes and intermediate hyperglycaemia, which together affect roughly a third of adults in Bangladesh. We aimed to assess the effects of mHealth and community mobilisation on the prevalence of intermediate hyperglycaemia and diabetes among the general adult population in rural Bangladesh, and to assess the effect of these interventions on the incidence of type 2 diabetes among people with intermediate hyperglycaemia within the study population.
METHODS


DMagic was a three-arm, cluster-randomised trial of participatory community mobilisation, mHealth mobile phone messaging, and usual care (control) in 96 villages (population roughly 125 000) in Bangladesh. Community mobilisation involved 18 monthly group meetings, led by lay facilitators, applying a participatory learning and action (PLA) cycle focused on diabetes prevention and control. mHealth involved twice-weekly voice messages over 14 months promoting behaviour change to reduce diabetes risk. The primary outcomes were the combined prevalence of type 2 diabetes and intermediate hyperglycaemia in the overall population at the end of the intervention implementation period, and 2-year cumulative incidence of type 2 diabetes in a cohort with intermediate hyperglycaemia at baseline. Primary outcomes were assessed through fasting blood glucose concentrations and 2-h oral glucose tolerance tests among a cross-section of adults aged 30 years and older and a cohort of individuals identified with intermediate hyperglycaemia. Prevalence findings are based on a cross-sectional survey at the end of the study; incidence findings are based on 2-year follow-up survey of a cohort of individuals identified with intermediate hyperglycaemia through a cross-sectional survey at baseline. We also assessed the cost-effectiveness of the interventions. This trial is registered with the ISRCTN registry, number ISRCTN41083256, and is completed.
FINDINGS


The study took place between June 27, 2015, and June 28, 2018, with the PLA intervention running in 32 villages from June, 2016, to December, 2017, and the mHealth intervention running in 32 villages from Oct 21, 2016, to Dec 24, 2017. End-of study prevalence was assessed in 11 454 individuals and incidence in 2100 individuals. There was a large reduction in the combined prevalence of type 2 diabetes and intermediate hyperglycaemia in the PLA group compared with the control group at the end of the study (adjusted [for stratification, clustering, and wealth] odds ratio [aOR] 0·36 [0·27-0·48]), with an absolute reduction of 20·7% (95% CI 14·6-26·7). Among 2470 adults with intermediate hyperglycaemia at baseline, 2100 (85%) were followed-up at 2 years. The 2-year cumulative incidence of diabetes in this cohort was significantly lower in the PLA group compared with control (aOR 0·39, 0·24-0·65), representing an absolute incidence reduction of 8·7% (3·5-14·0). There was no evidence of effect of mHealth on combined prevalence of intermediate hyperglycaemia and diabetes (aOR 0·93, 0·74-1·16) or the incidence of diabetes (1·02, 0·73-1·43). The incremental cost-effectiveness ratios for PLA were INT$316 per case of intermediate hyperglycaemia or type 2 diabetes prevented and $6518 per case of type 2 diabetes prevented among individuals with intermediate hyperglycaemia.
INTERPRETATION


Our data provide strong evidence to support the use of community mobilisation based on PLA to prevent type 2 diabetes in this rural Bangladeshi population. Despite raising knowledge and awareness of diabetes, the mHealth intervention did not change disease outcomes in our population. Replication studies in other populations should be a priority.
FUNDING


UK Medical Research Council.",2019,"There was no evidence of effect of mHealth on combined prevalence of intermediate hyperglycaemia and diabetes (aOR 0·93, 0·74-1·16) or the incidence of diabetes (1·02, 0·73-1·43).","['2470 adults with intermediate hyperglycaemia at baseline, 2100 (85%) were followed-up at 2 years', '96 villages (population roughly 125\u2008000) in Bangladesh', 'June 27, 2015, and June 28, 2018, with the PLA intervention running in 32 villages from June, 2016, to December, 2017, and the mHealth intervention running in 32 villages from Oct 21, 2016, to Dec 24, 2017', 'intermediate hyperglycaemia and diabetes among the general adult population in rural Bangladesh', 'people with intermediate hyperglycaemia within the study population', '11\u2008454 individuals and incidence in 2100 individuals', 'adults aged 30 years and older and a cohort of individuals identified with intermediate hyperglycaemia']","['mHealth and community mobilisation', 'mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic', 'Community mobilisation involved 18 monthly group meetings, led by lay facilitators, applying a participatory learning and action (PLA) cycle focused on diabetes prevention and control', 'participatory community mobilisation, mHealth mobile phone messaging, and usual care (control', 'PLA']","['incremental cost-effectiveness ratios', '2-year cumulative incidence of diabetes', 'combined prevalence of type 2 diabetes and intermediate hyperglycaemia', 'fasting blood glucose concentrations and 2-h oral glucose tolerance tests', 'diabetes risk', 'cost-effectiveness', '2-year cumulative incidence of type 2 diabetes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517782', 'cui_str': '454 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0185112', 'cui_str': 'Mobilizing (regime/therapy)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",2470.0,0.0494623,"There was no evidence of effect of mHealth on combined prevalence of intermediate hyperglycaemia and diabetes (aOR 0·93, 0·74-1·16) or the incidence of diabetes (1·02, 0·73-1·43).","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Fottrell', 'Affiliation': 'UCL Institute for Global Health, Faculty of Population Health Sciences, University College London, London, UK. Electronic address: e.fottrell@ucl.ac.uk.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Ahmed', 'Affiliation': 'Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'UCL Institute for Global Health, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Kuddus', 'Affiliation': 'Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Sanjit Kumer', 'Initials': 'SK', 'LastName': 'Shaha', 'Affiliation': 'Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'King', 'Affiliation': 'UCL Institute for Global Health, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Jennings', 'Affiliation': 'UCL Institute for Global Health, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Kohenour', 'Initials': 'K', 'LastName': 'Akter', 'Affiliation': 'Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tasmin', 'Initials': 'T', 'LastName': 'Nahar', 'Affiliation': 'Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Haghparast-Bidgoli', 'Affiliation': 'UCL Institute for Global Health, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'A K Azad', 'Initials': 'AKA', 'LastName': 'Khan', 'Affiliation': 'Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Costello', 'Affiliation': 'UCL Institute for Global Health, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Kishwar', 'Initials': 'K', 'LastName': 'Azad', 'Affiliation': 'Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30001-4']
1022,31144648,A Method to Detect Presence of Chest Compressions During Resuscitation Using Transthoracic Impedance.,"OBJECTIVE


Interruptions in chest compressions during treatment of out-of-hospital cardiac arrest are associated with lower likelihood of successful resuscitation. Real-time automated detection of chest compressions may improve CPR administration during resuscitation, and could facilitate application of next-generation ECG algorithms that employ different parameters depending on compression state. In contrast to accelerometer sensors, transthoracic impedance (TTI) is commonly acquired by defibrillators. We sought to develop and evaluate the performance of a TTI-based algorithm to automatically detect chest compressions.
METHODS


Five-second TTI segments were collected from patients with out-of-hospital cardiac arrest treated by one of four defibrillator models. Segments with and without chest compressions were collected prior to each of the first four defibrillation shocks (when available) from each case. Patients were divided randomly into 40% training and 60% validation groups. From the training segments, we identified spectral and time-domain features of the TTI associated with compressions. We used logistic regression to predict compression state from these features. Performance was measured by sensitivity and specificity in the validation set. The relationship between performance and TTI segment length was also evaluated.
RESULTS


The algorithm was trained using 1859 segments from 460 training patients. Validation sensitivity and specificity were >98% using 2727 segments from 691 validation patients. Validation performance was significantly reduced using segments shorter than 3.2 s.
CONCLUSIONS


A novel method can reliably detect the presence of chest compressions using TTI. These results suggest potential to provide real-time feedback in order to improve CPR performance or facilitate next-generation ECG rhythm algorithms during resuscitation.",2020,"Validation performance was significantly reduced using segments shorter than 3.2 s.
CONCLUSIONS


",['Five-second TTI segments were collected from patients with out-of-hospital cardiac arrest treated by one of four defibrillator models'],[],"['performance and TTI segment length', 'sensitivity and specificity', 'Validation sensitivity and specificity', 'Validation performance', 'CPR performance']","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0761034', 'cui_str': 'tsetse thrombin inhibitor'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",[],"[{'cui': 'C0761034', 'cui_str': 'tsetse thrombin inhibitor'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}]",,0.0151684,"Validation performance was significantly reduced using segments shorter than 3.2 s.
CONCLUSIONS


","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Coult', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Blackwood', 'Affiliation': ''}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Rea', 'Affiliation': ''}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kudenchuk', 'Affiliation': ''}, {'ForeName': 'Heemun', 'Initials': 'H', 'LastName': 'Kwok', 'Affiliation': ''}]",IEEE journal of biomedical and health informatics,['10.1109/JBHI.2019.2918790']
1023,30626264,"A Longitudinal Analysis of the Substance Abuse, Violence, and HIV/AIDS (SAVA) Syndemic among Women in the Criminal Justice System.","Using data from a randomized controlled trial of 319 women mainly recruited from a Municipal Drug Court System in St. Louis, MO, this study evaluates substance use, victimization, and HIV/AIDS risk behaviors over time. The results indicated that, for all participants, the likelihood of victimization, using drugs, and meeting the criteria for HIV/AIDS risk decreased by 46% by the eight-month follow-up; however, results did not differ significantly by intervention group. Women who were sexually abused as a child, had 4+ arrests, or believed they had sexual and drug-using behaviors that need changing at baseline were more likely to experience these issues over time.",2019,"The results indicated that, for all participants, the likelihood of victimization, using drugs, and meeting the criteria for HIV/AIDS risk decreased by 46% by the eight-month follow-up; however, results did not differ significantly by intervention group.","['319 women mainly recruited from a Municipal Drug Court System in St. Louis, MO, this study evaluates substance use, victimization, and HIV/AIDS risk behaviors over time', 'Women who were sexually abused as a child, had 4+\xa0arrests, or believed they had sexual and drug-using behaviors']",[],"['likelihood of victimization, using drugs, and meeting the criteria for HIV/AIDS risk']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],"[{'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",319.0,0.0340329,"The results indicated that, for all participants, the likelihood of victimization, using drugs, and meeting the criteria for HIV/AIDS risk decreased by 46% by the eight-month follow-up; however, results did not differ significantly by intervention group.","[{'ForeName': 'Abenaa Acheampong', 'Initials': 'AA', 'LastName': 'Jones', 'Affiliation': 'a Department of Mental Health , Johns Hopkins School of Public Health , Baltimore , MD , USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Gerke', 'Affiliation': 'b Moffitt Cancer Center , Tampa , FL , USA.'}, {'ForeName': 'Catherine W', 'Initials': 'CW', 'LastName': 'Striley', 'Affiliation': 'c Department of Epidemiology , University of Florida , Gainesville , FL , USA.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Osborne', 'Affiliation': 'c Department of Epidemiology , University of Florida , Gainesville , FL , USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Whitehead', 'Affiliation': 'd Department of Clinical and Health Psychology , University of Florida , Gainesville , FL , USA.'}, {'ForeName': 'Linda B', 'Initials': 'LB', 'LastName': 'Cottler', 'Affiliation': 'c Department of Epidemiology , University of Florida , Gainesville , FL , USA.'}]",Journal of psychoactive drugs,['10.1080/02791072.2018.1562132']
1024,31805967,Cortisol total/CRP ratio for the prediction of hospital-acquired pneumonia and initiation of corticosteroid therapy in traumatic brain-injured patients.,"BACKGROUND


To propose a combination of blood biomarkers for the prediction of hospital-acquired pneumonia (HAP) and for the selection of traumatic brain-injured (TBI) patients eligible for corticosteroid therapy for the prevention of HAP.
METHODS


This was a sub-study of the CORTI-TC trial, a multicenter, randomized, double-blind, controlled trial evaluating the risk of HAP at day 28 in 336 TBI patients treated or not with corticosteroid therapy. Patients were between 15 and 65 years with severe traumatic brain injury (Glasgow coma scale score ≤ 8 and trauma-associated lesion on brain CT scan) and were enrolled within 24 h of trauma. The blood levels of CRP and cortisol total&free,  as a surrogate marker of the pro/anti-inflammatory response balance, were measured in samples collected before the treatment initiation. Endpoint was HAP on day 28.
RESULTS


Of the 179 patients with available samples, 89 (49.7%) developed an HAP. Cortisol total&free  and CRP blood levels upon ICU admission were not significantly different between patients with or without HAP. The cortisol total /CRP ratio upon admission was 2.30 [1.25-3.91] in patients without HAP and 3.36 [1.74-5.09] in patients with HAP (p = 0.021). In multivariate analysis, a cortisol total /CRP ratio > 3, selected upon the best Youden index on the ROC curve, was independently associated with HAP (OR 2.50, CI95% [1.34-4.64] p = 0.004). The HR for HAP with corticosteroid treatment was 0.59 (CI95% [0.34-1.00], p = 0.005) in patients with a cortisol total /CRP ratio > 3, and 0.89 (CI95% [0.49-1.64], p = 0.85) in patients with a ratio < 3.
CONCLUSION


A cortisol total /CRP ratio > 3 upon admission may predict the development of HAP in severe TBI. Among these patients, corticosteroids reduce the occurrence HAP. We suggest that this ratio may select the patients who may benefit from corticosteroid therapy for the prevention of HAP.",2019,Cortisol total&free  and CRP blood levels upon ICU admission were not significantly different between patients with or without HAP.,"['179 patients with available samples, 89 (49.7%) developed an HAP', '336 TBI patients treated or not with', 'Patients were between 15 and 65\u2009years with severe traumatic brain injury (Glasgow coma scale score ≤\u20098 and trauma-associated lesion on brain CT scan) and were enrolled within 24\u2009h of trauma', 'traumatic brain-injured patients']",['corticosteroid therapy'],"['Cortisol total/CRP ratio', 'occurrence HAP', 'Cortisol total&free  and CRP blood levels upon ICU admission', 'cortisol total /CRP ratio', 'cortisol total /CRP ratio upon admission', 'blood levels of CRP and cortisol total&free,  as a surrogate marker of the pro/anti-inflammatory response balance']","[{'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0412585', 'cui_str': 'Computerized axial tomography of brain'}, {'cui': 'C0441633'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0086589', 'cui_str': 'Surrogate Markers'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",336.0,0.129044,Cortisol total&free  and CRP blood levels upon ICU admission were not significantly different between patients with or without HAP.,"[{'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Bouras', 'Affiliation': 'Surgical Intensive Care Unit, Hotel-Dieu, University Hospital of Nantes, 44093, Nantes, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Roquilly', 'Affiliation': 'Surgical Intensive Care Unit, Hotel-Dieu, University Hospital of Nantes, 44093, Nantes, France.'}, {'ForeName': 'Pierre-Joachim', 'Initials': 'PJ', 'LastName': 'Mahé', 'Affiliation': 'Surgical Intensive Care Unit, Hotel-Dieu, University Hospital of Nantes, 44093, Nantes, France.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Cinotti', 'Affiliation': 'Surgical Intensive Care Unit, Hotel-Dieu, University Hospital of Nantes, 44093, Nantes, France.'}, {'ForeName': 'Mickaël', 'Initials': 'M', 'LastName': ""Vourc'h"", 'Affiliation': 'Surgical Intensive Care Unit, Hotel-Dieu, University Hospital of Nantes, 44093, Nantes, France.'}, {'ForeName': 'Bastien', 'Initials': 'B', 'LastName': 'Perrot', 'Affiliation': 'UMR_S 1246 Methods in Patient-Centered Outcomes and Health Research, Nantes University, 44000, Nantes, France.'}, {'ForeName': 'Kalyane', 'Initials': 'K', 'LastName': 'Bach-Ngohou', 'Affiliation': 'Biochemistry Laboratory, UMR INSERM 1235, University Hospital of Nantes, 44093, Nantes, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Masson', 'Affiliation': 'Biochemistry Laboratory, UMR INSERM 1235, University Hospital of Nantes, 44093, Nantes, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': 'Surgical Intensive Care Unit, Hotel-Dieu, University Hospital of Nantes, 44093, Nantes, France. karim.asehnoune@chu-nantes.fr.'}]","Critical care (London, England)",['10.1186/s13054-019-2680-6']
1025,31776362,The Effect of Strict Volume Control Assessed by Repeated Bioimpedance Spectroscopy on Cardiac Function in Peritoneal Dialysis Patients.,"Adequate fluid management plays an important role in decreasing cardiovascular risk in peritoneal dialysis (PD) patients. We evaluated whether strict volume control monitored by bioimpedance spectroscopy (BIS) affects cardiac function in PD patients. This study is a secondary analysis of a multicentre, prospective, randomized, controlled trial. Fluid overload was assessed by the average overhydration/extracellular water (OH/ECW) at baseline, 6 months and 12 months. Patients were categorized as time-averaged overhydrated (TA-OH/ECW ≥15%) or normohydrated (TA-OH/ECW <15%), and echocardiographic parameters were compared between groups. Among a total of 151 patients, 120 patients exhibited time-averaged normohydration. Time-averaged overhydrated patients had a significantly higher left atrial (LA) diameter and E/e' ratio and a lower left ventricular (LV) ejection fraction at 12 months than time-averaged normohydrated patients. LA diameter, end-systolic volume and end-diastolic volume were decreased at 12 months compared to baseline in time-averaged normohydrated patients only. TA-OH/ECW was independently associated with ejection fraction at 12 months (β = -0.190; p = 0.010). TA-OH/ECW, but not OH/ECW at 12 months, was an independent risk factor for LV dysfunction (odds ratio 4.020 [95% confidence interval 1.285-12.573]). Overhydration status based on repeated BIS measurements is an independent predictor of LV systolic function in PD patients.",2019,Time-averaged overhydrated patients had a significantly higher left atrial (LA) diameter and E/e' ratio and a lower left ventricular (LV) ejection fraction at 12 months than time-averaged normohydrated patients.,"['PD patients', 'peritoneal dialysis (PD) patients', 'Peritoneal Dialysis Patients', '151 patients, 120 patients exhibited time-averaged normohydration']","['strict volume control monitored by bioimpedance spectroscopy (BIS', 'Strict Volume Control Assessed by Repeated Bioimpedance Spectroscopy']","[""left atrial (LA) diameter and E/e' ratio and a lower left ventricular (LV) ejection fraction"", 'LA diameter, end-systolic volume and end-diastolic volume', 'Fluid overload', 'LV systolic function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0449972', 'cui_str': 'Volume control (attribute)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C2713504', 'cui_str': 'Spectroscopy'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia (disorder)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",151.0,0.0394168,Time-averaged overhydrated patients had a significantly higher left atrial (LA) diameter and E/e' ratio and a lower left ventricular (LV) ejection fraction at 12 months than time-averaged normohydrated patients.,"[{'ForeName': 'Yu Ah', 'Initials': 'YA', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Hye Eun', 'Initials': 'HE', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Bum Soon', 'Initials': 'BS', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Seok Joon', 'Initials': 'SJ', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Yong-Soo', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Eulji University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Ho', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Kyung Hee University Medical School, Seoul, Republic of Korea.'}, {'ForeName': 'Su Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea.'}, {'ForeName': 'Sug Kyun', 'Initials': 'SK', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Young Joo', 'Initials': 'YJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Internal Medicine, Korea University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Yoon Kyung', 'Initials': 'YK', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Suk Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Korea University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Shin Young', 'Initials': 'SY', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Korea University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Gang Jee', 'Initials': 'GJ', 'LastName': 'Ko', 'Affiliation': 'Department of Internal Medicine, Korea University School of Medicine, Seoul, Republic of Korea. lovesba@korea.ac.kr.'}]",Scientific reports,['10.1038/s41598-019-53792-0']
1026,30953549,Intervention for alcohol use disorders at an HIV care clinic in Harare: a pilot and feasibility study.,"BACKGROUND


Alcohol use in HIV infected patients is associated with risky sexual behaviour, poor adherence to Highly Active Antiretroviral Therapy, treatment failure and increased physiologic harm. The objectives of the study were to pilot the outcome assessments to be used in the trial proper, assess the feasibility of delivery of a brief MI/CBT intervention compared to an WHO mhGAP intervention for problematic alcohol use in PLWH in Zimbabwe, and pilot the effectiveness (on alcohol use, functionality and CD4 count) of these interventions at 3 months in a randomised controlled trial design.
METHODS


An intervention for HIV infected patients with problematic alcohol use, developed through adaptation of existing evidence based psychological treatments, was assessed for its feasibility at a tertiary HIV care clinic in Zimbabwe. Registered general nurses, using a manualised protocol, delivered the intervention. Forty patients were recruited and randomised to receive either an MI/CBT intervention or the WHO mhGAP Intervention Guide for AUDs (n = 20 patients per group).
RESULTS


Out of 40 participants enrolled, 31 were successfully followed up for 3 months with a loss to follow-up rate of 23%. There was a statistically significant decrease in AUDIT score over time in both groups (p < 0.001), however no statistically significant group difference with a mean difference of 0.80, standard error of 2.07 and p = 0.70. For the CD4 count, the median and interquartile ranges at baseline for MI/CBT and WHO mhGAP IG groups were 218 (274) and 484 (211.50), respectively. At follow-up, median and interquartile ranges for the CD4 count for MI/CBT and WHO mhGAP IG groups were 390 (280) and 567 (378), respectively, indicative of improvement in immunological parameters in both arms.
CONCLUSION


The findings from this pilot study suggests that a brief MI/CBT delivered by Registered General Nurses for problematic alcohol use is feasible in this population but will require the implementation of additional measures to improve retention. However, mechanisms to improve retention need special attention. Trial registration Pan African Clinical Trial Registry, current PACTR201509001211149.",2019,"There was a statistically significant decrease in AUDIT score over time in both groups (p < 0.001), however no statistically significant group difference with a mean difference of 0.80, standard error of 2.07 and p = 0.70.","['HIV infected patients with problematic alcohol use', '40 participants enrolled, 31 were successfully followed up for 3 months with a loss to follow-up rate of 23', 'alcohol use disorders at an HIV care clinic in Harare', 'Forty patients']","['MI/CBT intervention', 'WHO mhGAP intervention', 'MI/CBT intervention or the WHO mhGAP Intervention Guide for AUDs (n\u2009=\u200920 patients per group']",['AUDIT score'],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",40.0,0.0750398,"There was a statistically significant decrease in AUDIT score over time in both groups (p < 0.001), however no statistically significant group difference with a mean difference of 0.80, standard error of 2.07 and p = 0.70.","[{'ForeName': 'Munyaradzi', 'Initials': 'M', 'LastName': 'Madhombiro', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Parirenyatwa Group of Hospitals, Avondale, Zimbabwe. mmadhombiro@gmail.com.'}, {'ForeName': 'Bazondlile', 'Initials': 'B', 'LastName': 'Dube', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Parirenyatwa Group of Hospitals, Avondale, Zimbabwe.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Dube', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Parirenyatwa Group of Hospitals, Avondale, Zimbabwe.'}, {'ForeName': 'Moleen', 'Initials': 'M', 'LastName': 'Zunza', 'Affiliation': 'Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Dixon', 'Initials': 'D', 'LastName': 'Chibanda', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Parirenyatwa Group of Hospitals, Avondale, Zimbabwe.'}, {'ForeName': 'Simbarashe', 'Initials': 'S', 'LastName': 'Rusakaniko', 'Affiliation': 'Department of Community Medicine, College of Health Sciences, University of Zimbabwe, College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Seedat', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Health sciences, Stellenbosch University, Cape Town, South Africa.'}]",Addiction science & clinical practice,['10.1186/s13722-019-0143-7']
1027,30678465,Fish Oil Supplementation in Overweight/Obese Patients with Uncontrolled Asthma. A Randomized Trial.,"Rationale:  Omega-3 fatty acid (n3PUFA) supplementation has been proposed as a promising antiasthma strategy. The rs59439148  ALOX5  polymorphism affects leukotriene production and possibly inflammatory responses to n3PUFA.  Objectives:  Assess the effects of n3PUFA supplementation and  ALOX5  genotype on asthma control in patients with obesity and uncontrolled asthma.  Methods:  This multicenter trial among 12- to 25-year-olds with overweight/obesity and uncontrolled asthma randomized subjects in a 3:1 allotment to n3PUFA (4 g/d) or soy oil control for 24 weeks. Asthma Control Questionnaire was the primary outcome; secondary outcomes included blood leukocyte n3PUFA levels, urinary leukotriene-E4, spirometry, and asthma-related events. The number of SP1 tandem repeats in rs59439148 determined  ALOX5  genotype status. Simple and multivariable generalized linear models assessed effects on outcomes.  Results:  Ninety-eight participants were randomized (77 to PUFA, 21 to control), and more than 86% completed all visits. Asthma and demographic characteristics were similar among treatment groups. n3PUFA treatment increased the n3-to-n6 PUFA ratio in circulating granulocytes ( P  = 0.029) and monocytes ( P  = 0.004) but did not affect mean Asthma Control Questionnaire change at 6 months (n3PUFA: mean, -0.09; 95% confidence interval [CI], 0.09 to 0.10; vs. control: mean, -0.18; 95% CI, -0.42 to 0.06;  P  = 0.58). Changes in urinary leukotriene-E4 ( P  = 0.24), forced expiratory volume in 1 second % predicted ( P  = 0.88), and exacerbations (relative risk [RR], 0.92; 95% CI, 0.30-2.89) at 6 months were similar in both groups. n3PUFA treatment was associated with reduced asthma-related phone contacts (RR, 0.34; 95% CI, 0.13-0.86;  P  = 0.02).  ALOX5  genotype did not affect n3PUFA treatment responses.  Conclusions:  We did not find evidence that n3PUFA use improves most asthma-related outcomes and cannot recommend it as a prevention strategy for overweight/obese patients with asthma. Clinical trial registered with www.clinicaltrials.gov (NCT01027143).",2019,"Changes in urinary leukotriene-E4 ( P  = 0.24), forced expiratory volume in 1 second % predicted ( P  = 0.88), and exacerbations (relative risk [RR], 0.92; 95% CI, 0.30-2.89) at 6 months were similar in both groups.","['patients with obesity and uncontrolled asthma', 'Ninety-eight participants were randomized (77 to PUFA, 21 to control), and more than 86% completed all visits', 'Overweight/Obese Patients with Uncontrolled Asthma', 'overweight/obese patients with asthma', '12- to 25-year-olds with overweight/obesity and uncontrolled asthma randomized subjects in a 3:1 allotment to']","['n3PUFA', 'n3PUFA supplementation and  ALOX5  genotype', 'Omega-3 fatty acid (n3PUFA) supplementation', 'soy oil control', 'Fish Oil Supplementation']","['blood leukocyte n3PUFA levels, urinary leukotriene-E4, spirometry, and asthma-related events', 'n3-to-n6 PUFA ratio in circulating granulocytes', 'reduced asthma-related phone contacts', 'number of SP1 tandem repeats', 'forced expiratory volume', 'urinary leukotriene-E4', 'mean Asthma Control Questionnaire change']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557715', 'cui_str': 'Allotment (environment)'}]","[{'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C0005768'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0125644', 'cui_str': 'LTE4'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0450544', 'cui_str': 'SP1 (body structure)'}, {'cui': 'C0039290', 'cui_str': 'Tandem Repeats'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",98.0,0.211276,"Changes in urinary leukotriene-E4 ( P  = 0.24), forced expiratory volume in 1 second % predicted ( P  = 0.88), and exacerbations (relative risk [RR], 0.92; 95% CI, 0.30-2.89) at 6 months were similar in both groups.","[{'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Lang', 'Affiliation': '1 Division of Allergy/Immunology and Pulmonary Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Mougey', 'Affiliation': ""2 Center for Pharmacogenomics and Translational Research, Nemours Children's Health System, Jacksonville, Florida.""}, {'ForeName': 'Md Jobayer', 'Initials': 'MJ', 'LastName': 'Hossain', 'Affiliation': '3 Center for Pediatric Research, Alfred I. DuPont Hospital of Children, Wilmington, Delaware.'}, {'ForeName': 'Floyd', 'Initials': 'F', 'LastName': 'Livingston', 'Affiliation': ""4 Nemours Children's Hospital, Orlando, Florida.""}, {'ForeName': 'P Babu', 'Initials': 'PB', 'LastName': 'Balagopal', 'Affiliation': ""5 Biomedical Analysis Laboratory, Nemours Children's Specialty Care, Jacksonville, Florida; and.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Langdon', 'Affiliation': '6 Department of Immunology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Lima', 'Affiliation': ""2 Center for Pharmacogenomics and Translational Research, Nemours Children's Health System, Jacksonville, Florida.""}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201807-446OC']
1028,32077514,Comparison of acupuncture on specific and non-specific points for the treatment of painful temporomandibular disorders: A randomised controlled trial.,"BACKGROUND AND OBJECTIVE


The aim of this single-centre, two-arm, parallel-group, double-blinded, randomised controlled trial was to investigate the disputed specific effectiveness of acupuncture by comparing acupuncture on specific and non-specific points among patients with non-chronic, painful TMDs.
METHODS


Following predefined eligibility criteria, 49 consecutive patients of both sexes were recruited to the study. All subjects were diagnosed with a non-chronic (Graded Chronic Pain Scale grade <3) painful TMD, as assessed using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Patients were randomly assigned to group A (acupuncture on specific points) or group B (acupuncture on non-specific points) after the initial examination (T0). Both acupuncture treatment sessions were conducted by a trained dentist once a week for four weeks. The examination was repeated five weeks (T5) after T0 by one calibrated examiner who was unaware of the study groups. Characteristic pain intensity (CPI) was evaluated as the main outcome criterion and compared between times and treatment groups by means of non-parametric tests (significance level set at P = .05). Secondary outcomes comprised the maximum corrected active mouth-opening without pain (MAO); patients' expectations regarding acupuncture treatment and pain development; depressivity; and oral health-related quality of life (OHRQoL).
RESULTS


A total of 41 patients (38 female) successfully completed the study (mean age: 40.17 ± 16.61). The two groups did not differ significantly at any time in terms of age and CPI. However, CPI was significantly (P < .05) lower at T5 than at T0 for both groups (29.66 and 30.35% lower in group A and group B, respectively). An increase in MAO was observed at T5 for both groups but was significant for group B only (P = .016). All patients had positive expectations of acupuncture therapy, and the two groups did not differ significantly at T5 with regard to the extent to which their expectations had been fulfilled by the treatment (P = .717). Comparison of T0 and T5 showed a statistically significant reduction of depressivity for group A (P = .0205), but no significant change for group B (P = .329). At T5, OHRQoL had improved significantly for both groups (group A, P = .018; group B, P < .001) compared with at T0.
CONCLUSIONS


Acupuncture on both specific and non-specific points reduces the non-dysfunctional pain of TMD patients. The effect of acupuncture on painful TMD cannot be attributed to the specific point selection.",2020,"At T5, OHRQoL had improved significantly for both groups (group A, p=0.018; group B, p<0.001) compared with at T0.
","['Following predefined eligibility criteria, 49 consecutive patients of both sexes were recruited to the study', 'All subjects were diagnosed with a non-chronic (Graded Chronic Pain Scale grade<3) painful TMD, as assessed using the Diagnostic Criteria for Temporomandibular Disorders', 'painful temporomandibular disorders', '41 patients (38 female) successfully completed the study (mean age: 40.17 ±16.61', 'patients with non-chronic, painful TMDs']","['acupuncture', 'Acupuncture', 'acupuncture on specific points) or group B (acupuncture on non-specific points']","['CPI', 'Characteristic pain intensity (CPI', ""maximum corrected active mouth-opening without pain (MAO); patients' expectations regarding acupuncture treatment and pain development; depressivity; and oral-health-related quality of life (OHRQoL"", 'MAO']","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}]","[{'cui': 'C0130753', 'cui_str': 'calpain inhibitor 2'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0026454', 'cui_str': 'MAO'}]",49.0,0.168132,"At T5, OHRQoL had improved significantly for both groups (group A, p=0.018; group B, p<0.001) compared with at T0.
","[{'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Şen', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Gül', 'Initials': 'G', 'LastName': 'Orhan', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Sertel', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Schmitter', 'Affiliation': 'Department of Prosthodontics, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Schindler', 'Affiliation': 'Department of Prosthodontics, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lux', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Nikolaos Nikitas', 'Initials': 'NN', 'LastName': 'Giannakopoulos', 'Affiliation': 'Department of Prosthodontics, University of Würzburg, Würzburg, Germany.'}]",Journal of oral rehabilitation,['10.1111/joor.12952']
1029,30520424,Simplifying the ShangRing technique for circumcision in boys and men: use of the no-flip technique with randomization to removal at 7 days versus spontaneous detachment.,"To assess safety of the no-flip ShangRing male circumcision technique and to determine clinical course and safety of spontaneous detachment (i.e., allowing the device to fall off), we conducted a case series of no-flip ShangRing circumcision combined with a randomized controlled trial of removal 7 days postcircumcision versus spontaneous detachment at two health facilities in Kenya. The primary outcome was the safety of the no-flip technique based on moderate and severe adverse events (AEs) during the procedure and through 42-day follow-up. A main secondary outcome was clinical course and safety of spontaneous detachment. Two hundred and thirty males 10 years and older underwent no-flip circumcision; 114 randomized to 7-day removal and 116 to spontaneous detachment. All circumcisions were successfully completed. Overall 5.3% (6/114) of participants in the 7-day group and 1.7% (2/116) in the spontaneous group had an AE; with no differences when compared to the 3% AE rate in historical data from African studies using the original flip technique (P = 0.07 and P = 0.79, respectively). Overall 72.4% (84/116) of participants in the spontaneous group wore the ShangRing until it detached. Among the remaining (27.6%; 32/116), the ring was removed, primarily at the participants' request, due to pain or discomfort. There was no difference in AE rates (P = 0.169), visit day declared healed (P = 0.324), or satisfaction (P = 0.371) between randomization groups. The median time to detachment was 14.0 (IQR: 7-21, range: 5-35) days. The no-flip technique and spontaneous detachment are safe, effective, and acceptable to boys and men 10 years and older. Phimosis and penile adhesions do not limit successful ShangRing circumcision with the no-flip technique.",2019,"The no-flip technique and spontaneous detachment are safe, effective, and acceptable to boys and men 10 years and older.","['Two hundred and thirty males 10 years and older', 'boys and men', 'versus spontaneous detachment at two health facilities in Kenya']","['removal 7 days postcircumcision', 'no-flip circumcision']","['pain or discomfort', 'safety of the no-flip technique based on moderate and severe adverse events (AEs', 'median time to detachment', 'clinical course and safety of spontaneous detachment', 'AE rates']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0541879', 'cui_str': 'Detachment'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}]","[{'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0540654', 'cui_str': 'FLICE-Inhibitory Protein'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0540654', 'cui_str': 'FLICE-Inhibitory Protein'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0541879', 'cui_str': 'Detachment'}, {'cui': 'C0449259', 'cui_str': 'Clinical course (attribute)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}]",230.0,0.131332,"The no-flip technique and spontaneous detachment are safe, effective, and acceptable to boys and men 10 years and older.","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Barone', 'Affiliation': 'EngenderHealth, Washington, DC 20004, USA.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Li', 'Affiliation': 'Center for Male Reproductive Medicine and Surgery, Department of Urology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY 10065, USA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Lee', 'Affiliation': 'Center for Male Reproductive Medicine and Surgery, Department of Urology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY 10065, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ouma', 'Affiliation': 'EngenderHealth, Nairobi 00100, Kenya.'}, {'ForeName': 'Millicent', 'Initials': 'M', 'LastName': 'Oundo', 'Affiliation': 'EngenderHealth, Nairobi 00100, Kenya.'}, {'ForeName': 'Mukhaye', 'Initials': 'M', 'LastName': 'Barasa', 'Affiliation': 'Bon Santé Consulting, Nairobi 00100, Kenya.'}, {'ForeName': 'Jairus', 'Initials': 'J', 'LastName': 'Oketch', 'Affiliation': 'Homa Bay County Teaching and Referral Hospital, Homa Bay 40300, Kenya.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Otiende', 'Affiliation': 'Homa Bay County Teaching and Referral Hospital, Homa Bay 40300, Kenya.'}, {'ForeName': 'Nixon', 'Initials': 'N', 'LastName': 'Nyangweso', 'Affiliation': 'Homa Bay County Teaching and Referral Hospital, Homa Bay 40300, Kenya.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Maina', 'Affiliation': 'Vipingo Health Centre, Vipingo 80119, Kenya.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kiswi', 'Affiliation': 'Vipingo Health Centre, Vipingo 80119, Kenya.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Chirchir', 'Affiliation': 'Bon Santé Consulting, Nairobi 00100, Kenya.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'Center for Male Reproductive Medicine and Surgery, Department of Urology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY 10065, USA.'}, {'ForeName': 'Quentin D', 'Initials': 'QD', 'LastName': 'Awori', 'Affiliation': 'EngenderHealth, Nairobi 00100, Kenya.'}]",Asian journal of andrology,['10.4103/aja.aja_91_18']
1030,31473324,Targeted hypothermia versus targeted Normothermia after out-of-hospital cardiac arrest (TTM2): A randomized clinical trial-Rationale and design.,"BACKGROUND


Less than 500 participants have been included in randomized trials comparing hypothermia with regular care for out-of-hospital cardiac arrest patients, and many of these trials were small and at a high risk of bias. Consequently, the accrued data on this potentially beneficial intervention resembles that of a drug following small phase II trials. A large confirmatory trial is therefore warranted.
METHODS


The TTM2-trial is an international, multicenter, parallel group, investigator-initiated, randomized, superiority trial in which a target temperature of 33°C after cardiac arrest will be compared with a strategy to maintain normothermia and early treatment of fever (≥37.8°C). Participants will be randomized within 3 hours of return of spontaneous circulation with the intervention period lasting 40 hours in both groups. Sedation will be mandatory for all patients throughout the intervention period. The clinical team involved with direct patient care will not be blinded to allocation group due to the inherent difficulty in blinding the intervention. Prognosticators, outcome-assessors, the steering group, the trial coordinating team, and trial statistician will be blinded. The primary outcome will be all-cause mortality at 180 days after randomization. We estimate a 55% mortality in the control group. To detect an absolute risk reduction of 7.5% with an alpha of 0.05 and 90% power, 1900 participants will be enrolled. The main secondary neurological outcome will be poor functional outcome (modified Rankin Scale 4-6) at 180 days after arrest.
DISCUSSION


The TTM2-trial will compare hypothermia to 33°C with normothermia and early treatment of fever (≥37.8°C) after out-of-hospital cardiac arrest.",2019,"The main secondary neurological outcome will be poor functional outcome (modified Rankin Scale 4-6) at 180 days after arrest.
","['1900 participants will be enrolled', '500 participants']","['Targeted hypothermia versus targeted Normothermia after out-of-hospital cardiac arrest (TTM2', 'hypothermia with regular care']","['cause mortality', 'poor functional outcome (modified Rankin Scale 4-6', 'absolute risk reduction']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}]","[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",1900.0,0.176313,"The main secondary neurological outcome will be poor functional outcome (modified Rankin Scale 4-6) at 180 days after arrest.
","[{'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Dankiewicz', 'Affiliation': 'Lund University, Skåne University Hospital, Department of Clinical Sciences, Cardiology, Lund, Sweden. Electronic address: josef.dankiewicz@med.lu.se.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Cronberg', 'Affiliation': 'Lund University, Skåne University Hospital, Department of Clinical Sciences, Neurology, Lund, Sweden.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Lilja', 'Affiliation': 'Lund University, Skåne University Hospital, Department of Clinical Sciences, Neurology, Lund, Sweden.'}, {'ForeName': 'Janus Christian', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bělohlávek', 'Affiliation': '2nd Department of Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Cariou', 'Affiliation': 'Medical Intensive Care Unit, Cochin University Hospital (APHP) and Paris Descartes University, Paris, France.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Lund University, Skåne University Hospital, Department of Clinical Sciences, Cardiology, Lund, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hovdenes', 'Affiliation': 'Department of Anesthesia and Intensive Care, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joannidis', 'Affiliation': 'Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Austria.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kirkegaard', 'Affiliation': 'Research Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University Hospital and Aarhus University, Aarhus N, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kuiper', 'Affiliation': 'Department of Intensive Care, Medical Center Leeuwarden, Leeuwarden, Netherlands.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Levin', 'Affiliation': 'Department of Research & Education, Lund University and Skåne University Hospital.'}, {'ForeName': 'Matt P G', 'Initials': 'MPG', 'LastName': 'Morgan', 'Affiliation': 'Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom.'}, {'ForeName': 'Alistair D', 'Initials': 'AD', 'LastName': 'Nichol', 'Affiliation': ""University College Dublin- Clinical Research Centre, St Vincent's University Hospital Dublin, Ireland; Australian and New Zealand Intensive Care-Research Centre, Monash University, Melbourne. Australia and Dept of Critical Care, Alfred Hospital, Melbourne, Australia.""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nordberg', 'Affiliation': 'Section of Cardiology, Stockholm, South General Hospital, Stockholm, Sweden.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Oddo', 'Affiliation': 'Department of Intensive Care Medicine, Centre Hospitalier Universitaire Vaudois (CHUV)-University Hospital, University of Lausanne, Faculty of Biology and Medicine.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, San Martino Policlinico Hospital, IRCCS for Oncology, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rylander', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Saxena', 'Affiliation': 'Division of Critical Care and Trauma, George Institute for Global Health. Intensive Care Unit, St George Hospital, Sydney, Australia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Storm', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Germany and Division of Neuroscience Critical Care, Department of Anesthesiology and Critical Care Medicin, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Ullén', 'Affiliation': 'Clinical Studies Sweden, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Wise', 'Affiliation': 'Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Friberg', 'Affiliation': 'Lund University, Skåne University Hospital, Department of Clinical Sciences, Anesthesia & Intensive care, Lund, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Lund University, Helsingborg Hospital, Department of Clinical Sciences Lund, Anesthesia & Intensive care, Lund, Sweden.'}]",American heart journal,['10.1016/j.ahj.2019.06.012']
1031,30723088,Examining intervention mechanisms of action using mediation analysis within a randomised trial of a whole-school health intervention.,"BACKGROUND


Interventions to modify school environments are effective in promoting young people's health across outcomes, but mechanisms are poorly understood. We assessed mediation in a trial of the Learning Together intervention, building on the recent publication of results of effectiveness for reducing bullying and benefits across secondary outcomes and generally good implementation fidelity.
METHODS


Within a cluster-randomised trial involving 40 English schools, we examined student-reported and staff-reported school climate and student-reported involvement with delinquent peers at 24-month and 36-month follow-up, assessing the reliability of measures and whether these mediated health outcomes at a final follow-up.
RESULTS


Response rates and reliability were good for student-reported but not staff-reported measures. The intervention increased student-reported but not staff-reported-positive school climate but, like effects on student health outcomes, these manifested only at a final follow-up. The intervention reduced student-reported contact with delinquent peers at an interim follow-up. Student-reported potential mediators measured at the interim follow-up were associated with most health outcomes at the final follow-up. Adjustment for student-reported school climate and contact with delinquent peers at the interim follow-up did not reduce the associations between trial arm and our health outcomes.
CONCLUSION


Despite being constrained by imperfect measures and by the late manifestation of impacts on student-reported school climate undermining ability to assess mediation, our study for the first time provides tentative evidence that mediation of intervention effects via improved climate and disengagement from delinquent peers is plausible. Our study provides the first evidence from a trial that whole-school interventions may work by modifying school environments and student relationships.
TRIAL REGISTRATION NUMBER


ISRCTN10751359.",2019,"The intervention increased student-reported but not staff-reported-positive school climate but, like effects on student health outcomes, these manifested only at a final follow-up.","['40 English schools, we examined student-reported and staff-reported school climate and student-reported involvement with delinquent peers at 24-month and 36-month follow-up']",[],['student health outcomes'],"[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",40.0,0.0535139,"The intervention increased student-reported but not staff-reported-positive school climate but, like effects on student health outcomes, these manifested only at a final follow-up.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Opondo', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Warren', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Diana Ruth', 'Initials': 'DR', 'LastName': 'Elbourne', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Sturgess', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bevilacqua', 'Affiliation': 'Department of Social Science, UCL Institute of Child Health, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McGowan', 'Affiliation': 'Department of Social Science, UCL Institute of Child Health, London, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Mathiot', 'Affiliation': 'Department of Social Science, UCL Institute of Child Health, London, UK.'}, {'ForeName': 'Russell M', 'Initials': 'RM', 'LastName': 'Viner', 'Affiliation': 'Department of Social Science, UCL Institute of Child Health, London, UK.'}]",Journal of epidemiology and community health,['10.1136/jech-2018-211443']
1032,31154306,Cluster randomised controlled trial of an m-health intervention in centre-based childcare services to reduce the packing of discretionary foods in children's lunchboxes: study protocol for the 'SWAP IT Childcare' trial.,"INTRODUCTION


In many developed nations, including Australia, a substantial number of children aged under 5 years attend centre-based childcare services that require parents to pack food in lunchboxes. These lunchboxes often contain excessive amounts of unhealthy ('discretionary') foods. This study aims to assess the impact of a mobile health (m-health) intervention on reducing the packing of discretionary foods in children's childcare lunchboxes.
METHODS AND ANALYSIS


A cluster randomised controlled trial will be undertaken with parents from 18 centre-based childcare services in the Hunter New England region of New South Wales, Australia. Services will be randomised to receive either a 4-month m-health intervention called 'SWAP IT Childcare' or usual care. The development of the intervention was informed by the Behaviour Change Wheel model and will consist primarily of the provision of targeted information, lunchbox food guidelines and website links addressing parent barriers to packing healthy lunchboxes delivered through push notifications via an existing app used by childcare services to communicate with parents and carers. The primary outcomes of the trial will be energy (kilojoules) from discretionary foods packed in lunchboxes and the total energy (kilojoules), saturated fat (grams), total and added sugars (grams) and sodium (milligrams) from all foods packed in lunchboxes. Outcomes will be assessed by weighing and photographing all lunchbox food items at baseline and at the end of the intervention.
ETHICS AND DISSEMINATION


The study was approved by the Hunter New England Local Health District Human Ethics Committee (06/07/26/4.04) and ratified by the University of Newcastle, Human Research Ethics Committee (H-2008-0343). Evaluation and process data collected as part of the study will be disseminated in peer-reviewed publications and local, national and international presentations and will form part of PhD student theses.
TRIAL REGISTRATION NUMBER


ACTRN12618000133235; Pre-results.",2019,"A cluster randomised controlled trial will be undertaken with parents from 18 centre-based childcare services in the Hunter New England region of New South Wales, Australia.","[""children's childcare lunchboxes"", ""children's lunchboxes"", 'parents from 18 centre-based childcare services in the Hunter New England region of New South Wales, Australia']","['m-health intervention', 'mobile health (m-health) intervention']","['energy (kilojoules) from discretionary foods packed in lunchboxes and the total energy (kilojoules), saturated fat (grams), total and added sugars (grams) and sodium (milligrams']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0027965', 'cui_str': 'Northeastern United States'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0439210', 'cui_str': 'milligram'}]",,0.179525,"A cluster randomised controlled trial will be undertaken with parents from 18 centre-based childcare services in the Hunter New England region of New South Wales, Australia.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pond', 'Affiliation': 'Population Health Unit, Hunter New England Local Health District, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Finch', 'Affiliation': 'Population Health Unit, Hunter New England Local Health District, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'Population Health Unit, Hunter New England Local Health District, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'Population Health Unit, Hunter New England Local Health District, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Nathan', 'Affiliation': 'Population Health Unit, Hunter New England Local Health District, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Kingsland', 'Affiliation': 'Population Health Unit, Hunter New England Local Health District, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Grady', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gillham', 'Affiliation': 'Population Health Unit, Hunter New England Local Health District, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Herrmann', 'Affiliation': 'Population Health Unit, Hunter New England Local Health District, Wallsend, New South Wales, Australia.'}, {'ForeName': 'Sze Lin', 'Initials': 'SL', 'LastName': 'Yoong', 'Affiliation': 'Population Health Unit, Hunter New England Local Health District, Wallsend, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-026829']
1033,31154315,Hope for the best …but expect the worst: a qualitative study to explore how women with recurrent miscarriage experience the early waiting period of a new pregnancy.,"OBJECTIVE


To investigate how women experience the initial period of a new pregnancy after suffering recurrent miscarriage (RM).
DESIGN


A qualitative study, nested within a randomised controlled feasibility study of a coping intervention for RM, used semi-structured face-to-face interviews. Interviews were audio-recorded, transcribed verbatim and analysed using a thematic network approach.
SETTING


Participants were recruited from the Recurrent Miscarriage Clinic and Early Pregnancy Unit in two tertiary referral hospitals in the UK.
PARTICIPANTS


14 women with RMs and who had previously participated in the randomised controlled trial (RCT) feasibility component of the study were recruited.
RESULTS


Seven organising themes emerged from the data: (1) turmoil of emotions, (2) preparing for the worst, (3) setting of personal milestones, (4) hypervigilance, (5) social isolation, (6) adoption of pragmatic approaches, (7) need for professional affirmation.
CONCLUSIONS


The study established that for women with a history of RM, the waiting period of a new pregnancy is a traumatic time of great uncertainty and emotional turmoil and one in which they express a need for emotional support. Consideration should be given to the manner in which supportive care is best delivered within the constraints of current health service provision.
TRIAL REGISTRATION NUMBER


ISRCTN43571276.",2019,"The study established that for women with a history of RM, the waiting period of a new pregnancy is a traumatic time of great uncertainty and emotional turmoil and one in which they express a need for emotional support.","['women experience the initial period of a new pregnancy after suffering recurrent miscarriage (RM', '14 women with RMs and who had previously participated in the randomised controlled trial (RCT) feasibility component of the study were recruited', 'Participants were recruited from the Recurrent Miscarriage Clinic and Early Pregnancy Unit in two tertiary referral hospitals in the UK', 'women with a history of RM, the waiting period of a new pregnancy']","['coping intervention for RM, used semi-structured face-to-face interviews']","['turmoil of emotions, (2) preparing for the worst, (3) setting of personal milestones, (4) hypervigilance, (5) social isolation, (6) adoption of pragmatic approaches, (7) need for professional affirmation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000809', 'cui_str': 'Recurrent Early Pregnancy Loss'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0425138', 'cui_str': 'Personal milestones (observable entity)'}, {'cui': 'C0235013', 'cui_str': 'Hypervigilance'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]",14.0,0.122257,"The study established that for women with a history of RM, the waiting period of a new pregnancy is a traumatic time of great uncertainty and emotional turmoil and one in which they express a need for emotional support.","[{'ForeName': 'Sarah Louise', 'Initials': 'SL', 'LastName': 'Bailey', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, Hants, UK.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Boivin', 'Affiliation': 'School of Psychology, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Ying C', 'Initials': 'YC', 'LastName': 'Cheong', 'Affiliation': 'Obstetrics and Gynaecology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Kitson-Reynolds', 'Affiliation': 'Midwifery, University of Southampton, Southampton, Hants, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bailey', 'Affiliation': 'Health Sciences, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Macklon', 'Affiliation': 'Medical Director, London Womens Clinic, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-029354']
1034,31154316,Investigating SOcial Competence and Isolation in children with Autism taking part in LEGO-based therapy clubs In School Environments (I-SOCIALISE): study protocol.,"INTRODUCTION


Social skills training interventions for children with autism spectrum disorder (ASD) typically focus on a skills deficit model rather than building on existing skills or encouraging the child to seek their own solutions. LEGO-based therapy is a child-oriented intervention to help improve social interactional skills and reduce isolation. The therapy is designed for school-age children with ASD and uses group-based play in a school setting to encourage peer relationships and social learning. Despite the reported potential benefits of LEGO-based therapy in a prior randomised controlled trial (RCT) and its adoption by many schools, the evidence to support its effectiveness on the social and emotional well-being of children with ASD is limited and includes no assessment of cost-effectiveness.
METHODS AND ANALYSIS


This multicentre, pragmatic, cluster RCT will randomise 240 participants (aged 7-15 years) with a clinical diagnosis of ASD to receive usual care or LEGO-based therapy with usual care. Cluster randomisation will be conducted on a school level, randomising each school as opposed to each individual child within a school. All prospective participants will be screened for eligibility before assenting to the study (with parents giving informed consent on behalf of their child). All participants will be followed up at 20 and 52 weeks after randomisation to assess for social, emotional and behavioural changes. The primary outcome measure is the social skills subscale of the Social Skills Improvement System completed by a teacher or teaching assistant associated with participating children at the 20-week follow-up time point.
ETHICS AND DISSEMINATION


Ethics approval has been obtained via the University of York Research Ethics Committee. The results of the trial will be submitted for publication in a peer-reviewed journal and will be disseminated to participating families, education practitioners and the third sector including voluntary and community organisations.
TRIAL REGISTRATION NUMBER


ISRCTN64852382; Pre-results.",2019,"All participants will be followed up at 20 and 52 weeks after randomisation to assess for social, emotional and behavioural changes.","['children with autism spectrum disorder (ASD', '240 participants (aged 7-15 years) with a clinical diagnosis of ASD to receive', 'school-age children with ASD', 'children with Autism taking part in LEGO-based therapy clubs In School Environments', 'All prospective participants will be screened for eligibility before assenting to the study (with parents giving informed consent on behalf of their child']","['Social skills training interventions', 'usual care or LEGO-based therapy with usual care', 'LEGO-based therapy']","['social skills subscale of the Social Skills Improvement System completed by a teacher or teaching assistant associated with participating children at the 20-week follow-up time point', 'social interactional skills']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0150777', 'cui_str': 'Social skills training (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",240.0,0.0518253,"All participants will be followed up at 20 and 52 weeks after randomisation to assess for social, emotional and behavioural changes.","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Varley', 'Affiliation': 'COMIC, Leeds and York Partnership NHS Foundation Trust, York, UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Wright', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'ScHARR, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Marshall', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Biggs', 'Affiliation': 'Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chater', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coates', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Gomez de la Cuesta', 'Affiliation': 'Cambridgeshire Community Services NHS Trust, Cambridge, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Kingsley', 'Affiliation': 'Leeds and York Partnership NHS Foundation Trust, York, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Le Couteur', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'McKelvey', 'Affiliation': 'City of York Council, York, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Shephard', 'Affiliation': 'Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Teare', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030471']
1035,32152811,"Inter-study repeatability of circumferential strain and diastolic strain rate by CMR tagging, feature tracking and tissue tracking in ST-segment elevation myocardial infarction.","Strain assessment allows accurate evaluation of myocardial function and mechanics in ST-segment elevation myocardial infarction (STEMI). Strain using cardiovascular magnetic resonance (CMR) has traditionally been assessed with tagging but limitations of this technique have led to more widespread use of alternative methods, which may be more robust. We compared the inter-study repeatability of circumferential global peak-systolic strain (Ecc) and peak-early diastolic strain rate (PEDSR) derived by tagging with values obtained using novel cine-based software: Feature Tracking (FT) (TomTec, Germany) and Tissue Tracking (TT) (Circle cvi 42 , Canada) in patients following STEMI. Twenty male patients (mean age 56 ± 10 years, mean infarct size 13.7 ± 7.1% of left ventricular mass) were randomised to undergo CMR 1-5 days post-STEMI at 1.5 T or 3.0 T, repeated after ten minutes at the same field strength. Ecc and PEDSR were assessed using tagging, FT and TT. Inter-study repeatability was evaluated using Bland-Altman analyses, coefficients of variation (CoV) and intra-class correlation coefficient (ICC). Ecc (%) was significantly lower with tagging than with FT or TT at 1.5 T (- 9.5 ± 3.3 vs. - 17.5 ± 3.8 vs. -15.5 ± 5.2, respectively, p < 0.001) and 3.0 T (- 13.1 ± 1.8 vs. - 19.4 ± 2.9 vs. - 17.3 ± 2.1, respectively, p = 0.001). This was similar for PEDSR (.s -1 ): 1.5 T (0.6 ± 0.2 vs. 1.5 ± 0.4 vs. 1.0 ± 0.4, for tagging, FT and TT respectively, p < 0.001) and 3.0 T (0.6 ± 0.2 vs. 1.5 ± 0.3 vs. 0.9 ± 0.3, respectively, p < 0.001). Inter-study repeatability for Ecc at 1.5 T was good for tagging and excellent for FT and TT: CoV 16.7%, 6.38%, and 8.65%, respectively. Repeatability for Ecc at 3.0 T was good for all three techniques: CoV 14.4%, 11.2%, and 13.0%, respectively. However, repeatability of PEDSR was generally lower than that for Ecc at 1.5 T (CoV 15.1%, 13.1%, and 34.0% for tagging, FT and TT, respectively) and 3.0 T (CoV 23.0%, 18.6%, and 26.2%, respectively). Following STEMI, Ecc and PEDSR are higher when measured with FT and TT than with tagging. Inter-study repeatability of Ecc is good for tagging, excellent for FT and TT at 1.5 T, and good for all three methods at 3.0 T. The repeatability of PEDSR is good to moderate at 1.5 T and moderate at 3.0 T. Cine-based methods to assess Ecc following STEMI may be preferable to tagging.",2020,Inter-study repeatability for Ecc at 1.5 T was good for tagging and excellent for FT and TT:,"['Twenty male patients (mean age 56\u2009±\u200910\xa0years, mean infarct size 13.7\u2009±\u20097.1% of left ventricular mass', 'ST-segment elevation myocardial infarction']","['cardiovascular magnetic resonance (CMR', 'tagging with values obtained using novel cine-based software: Feature Tracking (FT) (TomTec, Germany) and Tissue Tracking (TT', 'circumferential strain and diastolic strain rate by CMR tagging, feature tracking and tissue tracking', 'TT']","['circumferential global peak-systolic strain (Ecc) and peak-early diastolic strain rate (PEDSR', 'repeatability of PEDSR', 'coefficients of variation (CoV) and intra-class correlation coefficient (ICC', 'Ecc and PEDSR']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}]","[{'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}]",20.0,0.0337012,Inter-study repeatability for Ecc at 1.5 T was good for tagging and excellent for FT and TT:,"[{'ForeName': 'Sheraz A', 'Initials': 'SA', 'LastName': 'Nazir', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK. sn191@le.ac.uk.'}, {'ForeName': 'Abhishek M', 'Initials': 'AM', 'LastName': 'Shetye', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Jamal N', 'Initials': 'JN', 'LastName': 'Khan', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Anvesha', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Jayanth R', 'Initials': 'JR', 'LastName': 'Arnold', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Squire', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}]",The international journal of cardiovascular imaging,['10.1007/s10554-020-01806-8']
1036,31981597,Effect of Aromatherapy Massage on Quality of Sleep in the Palliative Care Ward: A Randomized Controlled Trial.,"CONTEXT


There is little evidence of the effectiveness of aromatherapy massage in palliative care despite its popularity.
OBJECTIVES


This study aimed to investigate the effects of a 30-minute single session of aromatherapy massage at night time on quality of sleep and fatigue in palliative care.
METHODS


A randomized controlled trial from January 2018 to March 2019. After being stratified by sex, participants were randomly assigned to an aromatherapy massage group and a control group. The effects of aromatherapy massage were evaluated on the massage day and the next day using the Richards-Campbell Sleep Questionnaire and the Brief Fatigue Inventory.
RESULTS


Of the 74 participants, data of 27 participants in the treatment group and 30 participants in the control group were analyzed. Analysis of covariance indicated that quality of sleep and fatigue did not improve owing to the aromatherapy massage, although usual fatigue in preceding 24 hours and enjoyment of life subscales of the Brief Fatigue Inventory showed signs of contribution (P = 0.07 and 0.09, respectively). Post hoc analyses indicated that higher age and performance status were factors with moderate correlation with better sleep (P = 0.03; r = 0.45 and P = 0.03; r = 0.40, respectively), and that older patients tended to experience greater improvement in fatigue (P = 0.02; r = -0.47).
CONCLUSION


A single aromatherapy massage session is no more effective than not having a massage in improving sleep quality in palliative care settings. However, older patients and those in poor health conditions may benefit from aromatherapy massage.",2020,A single aromatherapy massage session is no more effective than not having a massage in improving sleep quality in palliative care settings.,"['74 participants, data of 27 participants in the treatment group and 30 in the control group were analyzed', 'January 2018 to March 2019']","['aromatherapy massage session', 'aromatherapy massage']","['quality of sleep', 'Campbell Sleep Questionnaire (RCSQ) and the Brief Fatigue Inventory (BFI', 'sleep quality', 'quality of sleep and fatigue', 'fatigue', 'usual fatigue']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2585844', 'cui_str': 'Aromatherapy massage (regime/therapy)'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0546885,A single aromatherapy massage session is no more effective than not having a massage in improving sleep quality in palliative care settings.,"[{'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Kawabata', 'Affiliation': 'Department of Palliative Care, Osaka Rosai Hospital, Sakai City, Osaka, Japan. Electronic address: off.kawabata@gmail.com.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Hata', 'Affiliation': 'Department of Palliative Care, National Hospital Organization, Kyoto Medical Center, Fukakusa Mukaihata-cho Fushimi-ku, Kyoto City, Kyoto, Japan.'}, {'ForeName': 'Tomokazu', 'Initials': 'T', 'LastName': 'Aoki', 'Affiliation': 'Department of Palliative Care, National Hospital Organization, Kyoto Medical Center, Fukakusa Mukaihata-cho Fushimi-ku, Kyoto City, Kyoto, Japan.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.01.003']
1037,31269029,Online webinar training to analyse complex atrial fibrillation maps: A randomized trial.,"BACKGROUND


Specific tools have been recently developed to map atrial fibrillation (AF) and help guide ablation. However, when used in clinical practice, panoramic AF maps generated from multipolar intracardiac electrograms have yielded conflicting results between centers, likely due to their complexity and steep learning curve, thus limiting the proper assessment of its clinical impact.
OBJECTIVES


The main purpose of this trial was to assess the impact of online training on the identification of AF driver sites where ablation terminated persistent AF, through a standardized training program. Extending this concept to mobile health was defined as a secondary objective.
METHODS


An online database of panoramic AF movies was generated from a multicenter registry of patients in whom targeted ablation terminated non-paroxysmal AF, using a freely available method (Kuklik et al-method A) and a commercial one (RhythmView-method B). Cardiology Fellows naive to AF mapping were enrolled and randomized to training vs no training (control). All participants evaluated an initial set of movies to identify sites of AF termination. Participants randomized to training evaluated a second set of movies in which they received feedback on their answers. Both groups re-evaluated the initial set to assess the impact of training. This concept was then migrated to a smartphone application (App).
RESULTS


12 individuals (median age of 30 years (IQR 28-32), 6 females) read 480 AF maps. Baseline identification of AF termination sites by ablation was poor (40%±12% vs 42%±11%, P = 0.78), but similar for both mapping methods (P = 0.68). Training improved accuracy for both methods A (P = 0.001) and B (p = 0.012); whereas controls showed no change in accuracy (P = NS). The Smartphone App accessed AF maps from multiple systems on the cloud to recreate this training environment.
CONCLUSION


Digital online training improved interpretation of panoramic AF maps in previously inexperienced clinicians. Combining online clinical data, smartphone apps and other digital resources provides a powerful, scalable approach for training in novel techniques in electrophysiology.",2019,Training improved accuracy for both methods A (P = 0.001) and B (p = 0.012); whereas controls showed no change in accuracy (P = NS).,"['Cardiology Fellows naive to AF mapping', '12 individuals (median age of 30 years (IQR 28-32), 6 females) read 480 AF maps']","['online training', 'Online webinar training', 'Digital online training', 'training vs no training (control']",[],"[{'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0024779', 'cui_str': 'Map'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0487246,Training improved accuracy for both methods A (P = 0.001) and B (p = 0.012); whereas controls showed no change in accuracy (P = NS).,"[{'ForeName': 'João', 'Initials': 'J', 'LastName': 'Mesquita', 'Affiliation': 'Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia/Espinho, Gaia, Portugal.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Maniar', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, California, United States of America.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Baykaner', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, California, United States of America.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, California, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Swerdlow', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, California, United States of America.'}, {'ForeName': 'Mahmood I', 'Initials': 'MI', 'LastName': 'Alhusseini', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, California, United States of America.'}, {'ForeName': 'Fatemah', 'Initials': 'F', 'LastName': 'Shenasa', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, California, United States of America.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Brizido', 'Affiliation': 'Department of Cardiology, Centro Hospitalar de Lisboa Ocidental-Hospital de Santa Cruz, Carnaxide, Portugal.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Matos', 'Affiliation': 'Department of Cardiology, Centro Hospitalar de Lisboa Ocidental-Hospital de Santa Cruz, Carnaxide, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Freitas', 'Affiliation': 'Department of Cardiology, Centro Hospitalar de Lisboa Ocidental-Hospital de Santa Cruz, Carnaxide, Portugal.'}, {'ForeName': 'Ana Rita', 'Initials': 'AR', 'LastName': 'Santos', 'Affiliation': 'Department of Internal Medicine, Centro Hospitalar de Lisboa Ocidental-Hospital de São Francisco Xavier, Lisboa, Portugal.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Cardiology, Centro Hospitalar de Lisboa Ocidental-Hospital de Santa Cruz, Carnaxide, Portugal.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Silva', 'Affiliation': 'Department of Cardiology, Centro Hospitalar de Lisboa Ocidental-Hospital de Santa Cruz, Carnaxide, Portugal.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Rodrigo', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, California, United States of America.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiovascular Medicine, Stanford University, Stanford, California, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Clopton', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, California, United States of America.'}, {'ForeName': 'António M', 'Initials': 'AM', 'LastName': 'Ferreira', 'Affiliation': 'Department of Cardiology, Centro Hospitalar de Lisboa Ocidental-Hospital de Santa Cruz, Carnaxide, Portugal.'}, {'ForeName': 'Sanjiv M', 'Initials': 'SM', 'LastName': 'Narayan', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0217988']
1038,30768397,Changes in General and Specific Psychopathology Factors Over a Psychosocial Intervention.,"OBJECTIVE


Recent research suggests that comorbidity in child and adolescent psychiatric symptoms can be summarized by a single latent dimension known as the p factor and more specific factors summarizing clusters of symptoms. This study investigated within- and between-person changes in general and specific psychopathology factors over a psychosocial intervention.
METHOD


A secondary analysis was conducted of the Systemic Therapy for At-Risk Teens study, a pragmatic randomized controlled trial that compared the effects of multisystemic therapy with those of management as usual for decreasing antisocial behavior in 684 adolescents (82% boys; 11-18 years old at baseline) over an 18-month period. The general p factor and specific antisocial, attention, anxiety, and mood factors were estimated from a symptom-level analysis of a set of narrowband symptom scales measured repeatedly during the study. General and specific psychopathology factors were assessed for reliability, validity, and within- and between-person change using a parallel process multilevel growth model.
RESULTS


A revised bi-factor model that included a general p factor and specific anxiety, mood, antisocial, and attention factors with cross-loadings fit the data best. Although the factor structure was multidimensional, the p factor accounted for most of the variance in total scores. The p factor, anxiety, and antisocial factors predicted within-person variation in external outcomes. Furthermore, the p factor and antisocial factors showed within-person declines, whereas anxiety showed within-person increases, over time. Despite individual variation in baseline factor scores, adolescents showed similar rates of change.
CONCLUSION


The bi-factor model is useful for teasing apart general and specific therapeutic changes that are conflated in standard analyses of symptom scores.
CLINICAL TRIAL REGISTRATION INFORMATION


START (Systemic Therapy for At Risk Teens): A National Randomised Controlled Trial to Evaluate Multisystemic Therapy in the UK Context; http://www.isrctn.com; ISRCTN77132214.",2019,"Despite individual variation in baseline factor scores, adolescents showed similar rates of change.
","['At Risk Teens', '684 adolescents (82% boys; 11-18 years old at baseline) over an 18-month period']",['multisystemic therapy'],"['general p factor and specific antisocial, attention, anxiety, and mood factors']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C3840203', 'cui_str': 'Multisystemic therapy (regime/therapy)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",684.0,0.113647,"Despite individual variation in baseline factor scores, adolescents showed similar rates of change.
","[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Constantinou', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, UK. Electronic address: matthew.constantinou.13@ucl.ac.uk.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Goodyer', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Eisler', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK; South London and Maudsley NHS Foundation Trust, University College London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Butler', 'Affiliation': 'University of Prince Edward Island, Charlottetown, Canada.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Kraam', 'Affiliation': 'University of Leeds and Leeds Community Healthcare NHS Trust, Leeds, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pilling', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Simes', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ellison', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allison', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, UK.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.11.011']
1039,30652941,The Concise Health Risk Tracking-Self Report: Psychometrics within a placebo-controlled antidepressant trial among depressed outpatients.,"BACKGROUND/AIMS


While substantial prior research has evaluated the psychometric properties of the 12-item Concise Health Risk Tracking-Self Report (CHRT-SR 12 ), a measure of suicide propensity and suicidal thoughts, no prior research has investigated its factor structure, sensitivity to change over time, and other psychometric properties in a placebo-controlled trial of antidepressant medication, nor determined whether symptoms change throughout treatment.
METHODS


Participants in the multi-site Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study ( n=278) provided data to evaluate the factor structure and sensitivity to change over time of the CHRT-SR 12  through eight weeks of a clinical trial in which participants received either placebo or antidepressant medication (sertraline).
RESULTS/OUTCOMES


Factor analysis confirmed two factors: propensity (comprised of first-order factors including pessimism, helplessness, social support, and despair) and suicidal thoughts. Internal consistency (α's ranged from 0.69-0.92) and external validity were both acceptable, with the total score and propensity factor scores significantly correlated with total scores and single-item suicidal-thoughts scores on the self-report Quick Inventory of Depressive Symptoms and the clinician-rated 17-item Hamilton Rating Scale for Depression. Through analyzing CHRT-SR 12  changes over eight treatment weeks, the total score and both the factors decreased regardless of baseline suicidal thoughts. Change in clinician-rated suicidal thoughts was reflected by change in both the total score and propensity factor score.
CONCLUSIONS/INTERPRETATION


These results confirm the reliability, validity, and applicability of the CHRT-SR 12  to a placebo-controlled clinical trial of depressed outpatients receiving antidepressant medication.",2019,"Through analyzing CHRT-SR 12  changes over eight treatment weeks, the total score and both the factors decreased regardless of baseline suicidal thoughts.","['\n\n\nParticipants in the multi-site Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study ( n=278', 'depressed outpatients']","['placebo or antidepressant medication (sertraline', 'placebo']","['total scores and single-item suicidal-thoughts scores on the self-report Quick Inventory of Depressive Symptoms and the clinician-rated 17-item Hamilton Rating Scale for Depression', 'pessimism, helplessness, social support, and despair) and suicidal thoughts', 'total score and propensity factor scores', 'Change in clinician-rated suicidal thoughts', 'external validity']","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0424134', 'cui_str': 'Negative Thinking'}, {'cui': 'C0150063', 'cui_str': 'Feeling powerless (finding)'}, {'cui': 'C0037438'}, {'cui': 'C0233488', 'cui_str': 'Feeling despair (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",278.0,0.0357817,"Through analyzing CHRT-SR 12  changes over eight treatment weeks, the total score and both the factors decreased regardless of baseline suicidal thoughts.","[{'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Trombello', 'Affiliation': '1 Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Killian', 'Affiliation': '2 College of Social Work, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Grannemann', 'Affiliation': '1 Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Augustus John', 'Initials': 'AJ', 'LastName': 'Rush', 'Affiliation': '3 Department of Psychiatry, Duke Medical School, Durham, NC, USA.'}, {'ForeName': 'Taryn L', 'Initials': 'TL', 'LastName': 'Mayes', 'Affiliation': '1 Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Ramin V', 'Initials': 'RV', 'LastName': 'Parsey', 'Affiliation': '6 Department of Psychiatry, Stony Brook University, Stony Brook, NY USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': '7 Department of Psychiatry, University of Michigan, Ann Arbor, MI USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': '1 Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Aasia', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': '1 Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': '8 Department of Psychiatry, Columbia University, New York, NY USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': '9 New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': '10 Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Myrna M', 'Initials': 'MM', 'LastName': 'Weissman', 'Affiliation': '8 Department of Psychiatry, Columbia University, New York, NY USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Carmody', 'Affiliation': '1 Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': '1 Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881118817156']
1040,32149378,Effectiveness of Sexual Skills Training Program on Promoting Sexual Intimacy and Satisfaction in Women in Tehran (Iran): A randomized clinical Trial Study.,"PURPOSE


The purpose of this study was to evaluate the effectiveness of sexual skills training on intimacy and sexual satisfaction in women.
MATERIALS AND METHODS


This is a randomized clinical trial study with parallel design. 70 participants (n=35 each) were divided into 2 groups as control and intervention groups. Women were selected in multiple steps. Some requirements for inclusion criteria were: obtaining a standard score of marital satisfaction, women with a record of 6-24 months of marital life, not having a record of abortion, stillborn birth and not being in pregnancy period, not having a child, not suffering from an acute or chronic and serious disease, not having a surgery on pelvic organs, minimum elementary education of the couples and being Iranian. Some factors for exclusion criteria were: women's absence in more than 2 training classes, pregnancy during the study. Data collection was conducted through four questionnaires: demographic characteristics, marital satisfaction, sexual satisfaction and sexual intimacy. Validity and reliability of the questionnaires were measured through content validity and Chronbach Alpha, respectively. The data extracted from the questionnaires were analyzed using SPSS software, version 18.0. For data analysis, descriptive statistics, independent t-test, paired t-test, or non-parametric tests were applied. Significance level of the test was considered p<0.05.
RESULTS


The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
CONCLUSION


In total, the training lessons gave positive views to participants towards their sexual issues so that they formed realistic and positive sexual expectations, healthier sexual behaviors and self-expressions and consequently, gained more sexual knowledge that made them able to experience more intimacy and satisfaction in sexual relationships with their spouses.",2020,"The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
","['women', 'Women in Tehran (Iran', 'women with a record of 6-24 months of marital life, not having a record of abortion, stillborn birth and not being in pregnancy period, not having a child, not suffering from an acute or chronic and serious disease, not having a surgery on pelvic organs, minimum elementary education of the couples and being Iranian', '70 participants (n=35 each']","['Sexual Skills Training Program', 'sexual skills training']","['intimacy and sexual satisfaction', 'sexual satisfaction (p<0.001) and sexual intimacy', 'Sexual Intimacy and Satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C2355580', 'cui_str': 'Record of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0871356', 'cui_str': 'Sexual Satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",70.0,0.054477,"The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Salehi Moghaddam', 'Affiliation': 'Student Research committee, Department of Midwifery and Reproductive Health, school of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. fatemehsalehi28@yahoo.com.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'TurkZahrani', 'Affiliation': 'Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Moslemi', 'Affiliation': 'Department of Biostatistics, Faculty of Medical Sciences, Arak University of Medical Sciences ,Arak, Iran.'}, {'ForeName': 'Seyyed Ali', 'Initials': 'SA', 'LastName': 'Azin', 'Affiliation': 'MD, MPH, FECSM, Avicenna Research Institute, Academic Center for Education, Culture and Research (ACECR), Tehran, Iran.'}, {'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Ozgoli', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Joulaee Rad', 'Affiliation': 'Student Research committee, Department of Midwifery and Reproductive Health, school of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Urology journal,['10.22037/uj.v0i0.4690']
1041,31797880,Randomised trial on clinical performances and biocompatibility of four high-flux hemodialyzers in two mode treatments: hemodialysis vs post dilution hemodiafiltration.,"This prospective multicenter randomized comparative cross-over trial aimed at evaluating the influence of hemodialysis vs post-dilution hemodiafiltration with high-flux dialyzers in solute clearance and biocompatibility profile. 32 patients were sequentially dialyzed with Leoceed-21HX, Polypure-22S+, Rexsys-27H and VIE-21A. Primary outcome was β2-microglobulin removal. Secondary outcomes were (i) extraction of other uremic solutes (ii) parameters of inflammation and nutrition and (iii) comparative quantification of perdialytic albumin losses (using total 'TDC' vs partial 'PDC' collection of dialysate). Significant increases in removal rates of β2-microglobulin (84.7 ± 0.8 vs 71.6 ± 0.8 mg/L), myoglobin (65.9 ± 1.3 vs 38.6 ± 1.3 µg/L), free immunoglobulin light chains Kappa (74.9 ± 0.8 vs 55.6 ± 0.8 mg/L), β-trace protein (54.8 ± 1.3 vs 26.8 ± 1.4 mg/L) and orosomucoid (11.0 ± 1.1 vs 6.0 ± 1.1 g/L) but not myostatin (14.8 ± 1.5 vs 13.0 ± 1.5 ng/mL) were observed in HDF compared to HD when pooling all dialyzers. Rexsys and VIE-A use in both HD and HDF subgroups was associated to a better removal of middle/large-size molecules compared to Leoceed and Polypure, except β2-microglobulin for Rexsys. Inflammatory parameters were unchanged between dialyzers without any interaction with dialysis modality. Mean dialysate albumin loss was comparable between TDC and PDC (1.855 vs 1.826 g/session for TDC and PDC respectively). In addition, a significant difference in albumin loss was observed between dialyzers with the highest value (4.5 g/session) observed using Rexsys. Use of all dialyzers was associated with good removals of the large spectrum of uremic toxins tested and good biocompatibility profiles, with an additional gain in removal performances with HDF. Larger surface area, thinner wall and resultant very high ultrafiltration coefficient of Rexsys should be taken into account in its clear performance advantages.",2019,"Rexsys and VIE-A use in both HD and HDF subgroups was associated to a better removal of middle/large-size molecules compared to Leoceed and Polypure, except β2-microglobulin for Rexsys.","['32 patients were sequentially dialyzed with Leoceed-21HX, Polypure-22S+, Rexsys-27H and VIE-21A']",['hemodialysis vs post-dilution hemodiafiltration with high-flux dialyzers'],"['solute clearance and biocompatibility profile', 'β2-microglobulin removal', 'Mean dialysate albumin loss', 'Inflammatory parameters', ""i) extraction of other uremic solutes (ii) parameters of inflammation and nutrition and (iii) comparative quantification of perdialytic albumin losses (using total 'TDC' vs partial 'PDC' collection of dialysate"", 'albumin loss', 'β-trace protein', 'removal rates of β2-microglobulin', 'free immunoglobulin light chains Kappa']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0445431', 'cui_str': 'After the filter (qualifier value)'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0442822', 'cui_str': 'Trace (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0806492', 'cui_str': 'Free immunoglobulin light chain (substance)'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}]",32.0,0.0260797,"Rexsys and VIE-A use in both HD and HDF subgroups was associated to a better removal of middle/large-size molecules compared to Leoceed and Polypure, except β2-microglobulin for Rexsys.","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Morena', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Département de Biochimie et Hormonologie, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Creput', 'Affiliation': 'Service de Néphrologie, AURA, Paris, France.'}, {'ForeName': 'Mouloud', 'Initials': 'M', 'LastName': 'Bouzernidj', 'Affiliation': 'Service de Néphrologie, Clinique Hemera Pays de Caux, Yvetot, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Département de Biochimie et Hormonologie, CHU Montpellier, Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Chalabi', 'Affiliation': 'AIDER, Montpellier, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Seigneuric', 'Affiliation': 'Service de Néphrologie, CHU Toulouse, Toulouse, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lauret', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Département de Biochimie et Hormonologie, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Bargnoux', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Département de Biochimie et Hormonologie, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Dupuy', 'Affiliation': 'Département de Biochimie et Hormonologie, CHU Montpellier, Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Cristol', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Département de Biochimie et Hormonologie, CHU Montpellier, Montpellier, France. jp-cristol@chu-montpellier.fr.'}]",Scientific reports,['10.1038/s41598-019-54404-7']
1042,31867652,Effects of Framing Nicotine Reduction in Cigarettes on Anticipated Tobacco Product Use Intentions and Risk Perceptions Among US Adult Smokers.,"INTRODUCTION


In 2017, the US Food and Drug Administration (FDA) proposed lowering the amount of nicotine in combusted cigarettes to minimally addictive levels. If used, to encourage cessation and maximize the benefits of this action, the FDA needs to determine the most effective way to communicate to the public the practical impact of this nicotine tobacco product standard.
METHODS


Data were collected in 2018 from a nationally representative, online probability sample of 1198 adult smokers (aged ≥18 years old) in the United States. Smokers were randomly assigned one of five versions of the question regarding what they would most likely do if nicotine in cigarettes was reduced (nicotine levels were reduced by 95%; the government reduced nicotine levels by 95%; cigarettes were no longer addictive; cigarettes no longer relieved cravings; cigarettes were changed so that you would be able to quit more easily). Effects of framing on anticipated tobacco use intentions and perceived risk of very low nicotine cigarettes (VLNCs) were evaluated with multinomial logistic regressions.
RESULTS


Framing the nicotine tobacco product standard as cigarettes no longer relieved cravings resulted in the highest proportion of smokers reporting they intend to quit in response to this standard (43.9%), lowest proportions reporting anticipated intentions to continue using combusted tobacco products (45.3%), and lowest proportion believing that VLNCs are less harmful than regular cigarettes (26%).
CONCLUSIONS


Different frames of nicotine reduction in cigarettes differentially affected smokers' anticipated tobacco use intentions and perceived risk of VLNCs. Presenting reduction as making cigarettes unable to relieve cravings might be particularly effective at motivating cessation.",2019,"Effects of framing on anticipated tobacco use intentions and perceived risk of very low nicotine cigarettes (VLNCs) were evaluated with multinomial logistic regressions.
","['US Adult Smokers', 'Data were collected in 2018 from a nationally representative, online probability sample of 1198 adult smokers (aged ≥18 years old) in the United States']",['Framing Nicotine Reduction'],"['tobacco use intentions and perceived risk of VLNCs', 'addictive; cigarettes no longer relieved cravings; cigarettes', 'tobacco use intentions and perceived risk of very low nicotine cigarettes (VLNCs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0033206', 'cui_str': 'Probability Sample'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]",1198.0,0.048976,"Effects of framing on anticipated tobacco use intentions and perceived risk of very low nicotine cigarettes (VLNCs) were evaluated with multinomial logistic regressions.
","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Popova', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, GA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Owusu', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, GA.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Nyman', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, GA.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Weaver', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, GA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Communication, University of Arizona, Tucson, AZ.'}, {'ForeName': 'Jidong', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, GA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Ashley', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, GA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz146']
1043,31393176,Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring.,"Background:  The  G lycemia  R eduction  A pproaches in  D iabetes: A Comparative  E ffectiveness (GRADE) study has enrolled a racially and ethnically diverse population with type 2 diabetes, performed extensive phenotyping, and randomly assigned the participants to one of four second-line diabetes medications. The continuous glucose monitoring (CGM) substudy has been added to determine whether there are racial/ethnic differences in the relationship between average glucose (AG) and hemoglobin A1c (HbA1c). CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups.  Methods:  The observational CGM substudy will enroll up to 1800 of the 5047 GRADE study participants from the four treatment groups, including as many as 450 participants from each of 4 racial/ethnic minority groups to be compared: Hispanic White, non-Hispanic White, non-Hispanic African American, and non-Hispanic Other. CGM will be performed for 2 weeks in proximity to a GRADE annual visit, during which an oral glucose tolerance test will be performed and HbA1c and glycated albumin measured. Indicators of interindividual variation in red blood cell turnover, based on specialized erythrocyte measurements, will also be measured to explore the potential causes of interindividual HbA1c variations.  Conclusions:  The GRADE CGM substudy will provide new insights into whether differences exist in the relationship between HbA1c and AG among different racial/ethnic groups and whether glycemic profiles differ among frequently used diabetes medications and their potential clinical implications. Understanding such differences is important for clinical care and adjustment of diabetes medications in patients of different races or ethnicities.",2019,"CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups.  ","['Hispanic White, non-Hispanic White, non-Hispanic African American, and non-Hispanic Other', 'patients of different races or ethnicities', 'enrolled a racially and ethnically diverse population with type 2 diabetes', '1800 of the 5047 GRADE study participants from the four treatment groups, including as many as 450 participants from each of 4 racial/ethnic minority groups to be compared']",['CGM'],"['R eduction', 'average glucose (AG) and hemoglobin A1c (HbA1c']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]",[],"[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",450.0,0.0248676,"CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups.  ","[{'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larkin', 'Affiliation': 'Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nathan', 'Affiliation': 'Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ionut', 'Initials': 'I', 'LastName': 'Bebu', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Krause-Steinrauf', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Herman', 'Affiliation': 'Internal Medicine and Epidemiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Higgins', 'Affiliation': 'Department of Systems Biology, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Tiktin', 'Affiliation': 'Multidisciplinary Research, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'Cincinnati VA Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'Health Partners Institute, International Diabetes Center, Minneapolis, Minnesota.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'Health Partners Institute, International Diabetes Center, Minneapolis, Minnesota.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Arends', 'Affiliation': 'Advanced Research and Diagnostic Laboratory, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0202']
1044,31339533,Effectiveness of the American College of Surgeons Bleeding Control Basic Training Among Laypeople Applying Different Tourniquet Types: A Randomized Clinical Trial.,"Importance


More than 500 000 laypeople in the United States have been trained in hemorrhage control, including tourniquet application, under the Stop the Bleed campaign. However, it is unclear whether after hemorrhage control training participants become proficient in a specific type of tourniquet or can also use other tourniquets effectively.
Objective


To assess whether participants completing the American College of Surgeons Bleeding Control Basic (B-Con) training with Combat Application Tourniquets (CATs) can effectively apply bleeding control principles using other tourniquet types (commercial and improvised).
Design, Setting, and Participants


This nonblinded, crossover, sequential randomized clinical trial with internal control assessed a volunteer sample of laypeople who attended a B-Con course at Gillette Stadium and the Longwood Medical Area in Boston, Massachusetts, for correct application of each of 5 different tourniquet types immediately after B-Con training from April 4, 2018, to October 9, 2018. The order of application varied for each participant using randomly generated permutated blocks.
Interventions


Full B-Con course, including cognitive and skill sessions, that taught bleeding care, wound pressure and packing, and CAT application.
Main Outcomes and Measures


Correct tourniquet application (applied pressure of ≥250 mm Hg with a 2-minute time cap) in a simulated scenario for 3 commercial tourniquets (Special Operation Forces Tactical Tourniquet, Stretch-Wrap-and-Tuck Tourniquet, and Rapid Application Tourniquet System) and improvised tourniquet compared with correct CAT application as an internal control using 4 pairwise Bonferroni-corrected comparisons with the McNemar test.
Results


A total of 102 participants (50 [49.0%] male; median [interquartile range] age, 37.5 [27.0-53.0] years) were included in the study. Participants correctly applied the CAT at a significantly higher rate (92.2%) than all other commercial tourniquet types (Special Operation Forces Tactical Tourniquet, 68.6%; Stretch-Wrap-and-Tuck Tourniquet, 11.8%; Rapid Application Tourniquet System, 11.8%) and the improvised tourniquet (32.4%) (P < .001 for each pairwise comparison). When comparing tourniquets applied correctly, all tourniquet types had higher estimated blood loss, had longer application time, and applied less pressure than the CAT.
Conclusions and Relevance


The B-Con principles for correct CAT application are not fully translatable to other commercial or improvised tourniquet types. This study demonstrates a disconnect between the B-Con course and tourniquet designs available for bystander first aid, potentially stemming from the lack of consensus guidelines. These results suggest that current B-Con trainees may not be prepared to care for bleeding patients as tourniquet design evolves.
Trial Registration


ClinicalTrials.gov identifier: NCT03538379.",2019,"Participants correctly applied the CAT at a significantly higher rate (92.2%) than all other commercial tourniquet types (Special Operation Forces Tactical Tourniquet, 68.6%; Stretch-Wrap-and-Tuck Tourniquet, 11.8%;","['participants completing the American College of Surgeons', 'A total of 102 participants (50 [49.0%] male; median [interquartile range] age, 37.5 [27.0-53.0] years) were included in the study', 'volunteer sample of laypeople who attended a B-Con course at Gillette Stadium and the Longwood Medical Area in Boston, Massachusetts, for correct application of each of 5 different tourniquet types immediately after B-Con training from April 4, 2018, to October 9, 2018', 'American College of Surgeons Bleeding Control Basic Training Among Laypeople Applying Different Tourniquet Types']",['Bleeding Control Basic (B-Con) training with Combat Application Tourniquets (CATs'],"['commercial tourniquets (Special Operation Forces Tactical Tourniquet, Stretch-Wrap-and-Tuck Tourniquet, and Rapid Application Tourniquet System) and improvised tourniquet compared with correct CAT application as an internal control using 4 pairwise Bonferroni-corrected comparisons with the McNemar test', 'blood loss', 'Measures\n\n\nCorrect tourniquet application (applied pressure of ≥250 mm Hg with a 2-minute time cap']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0442588', 'cui_str': 'Stadium (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0524517', 'cui_str': 'Felis'}]","[{'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0445414', 'cui_str': 'Wrapping (procedure)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0204731', 'cui_str': 'Application of tourniquet (procedure)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]",102.0,0.0461564,"Participants correctly applied the CAT at a significantly higher rate (92.2%) than all other commercial tourniquet types (Special Operation Forces Tactical Tourniquet, 68.6%; Stretch-Wrap-and-Tuck Tourniquet, 11.8%;","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'McCarty', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Zain G', 'Initials': 'ZG', 'LastName': 'Hashmi', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Herrera-Escobar', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Elzerie', 'Initials': 'E', 'LastName': 'de Jager', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Muhammad Ali', 'Initials': 'MA', 'LastName': 'Chaudhary', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Lipsitz', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Jarman', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Caterson', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Goralnick', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA surgery,['10.1001/jamasurg.2019.2275']
1045,32146109,Are Postoperative Hip Precautions Necessary After Primary Total Hip Arthroplasty Using a Posterior Approach? Preliminary Results of a Prospective Randomized Trial.,"BACKGROUND


It is unclear whether posterior hip precautions after primary total hip arthroplasty (THA) reduce the incidence of early postoperative dislocation.
METHODS


We performed a prospective randomized study to evaluate the effect of hip precautions on incidence of early dislocation after primary THA using a posterior approach. Between January 2016 and April 2019, 587 patients (594 hips) were consented and randomized into restricted or unrestricted groups. No significant demographic or surgical differences existed between groups. The restricted group was instructed to refrain from hip flexion >90°, adduction across midline, and internal rotation for 6 weeks. 98.5% (585 of 594) of hips were available for minimum 6-week follow-up (291 restricted and 294 unrestricted). Power analysis showed that 579 hips per group are needed to demonstrate an increase in dislocation rate from 0.5% to 2.5% with 80% power.
RESULTS


At average follow-up of 15 weeks (range, 6-88), there were 5 dislocations (incidence, 0.85%). Three posterior dislocations occurred in the restricted group at a mean of 32 days (range, 17-47), and 2 posterior dislocations occurred in the unrestricted group at a mean of 112 days (range, 21-203), with no difference in dislocation rate between groups (1.03% vs 0.68%; odds ratio, 0.658; 95% confidence interval, 0.11-3.96; P = .647). At 6 weeks, unrestricted patients endorsed less difficulty with activities of daily living, earlier return to driving, and more time spent side sleeping (P < .05).
CONCLUSION


Preliminary analysis suggests that removal of hip precautions after primary THA using a posterior approach was not associated with early dislocation and facilitated return to daily functions. Investigation to appropriate power is warranted.",2020,"Three posterior dislocations occurred in the restricted group at a mean of 32 days (range, 17-47), and 2 posterior dislocations occurred in the unrestricted group at a mean of 112 days (range, 21-203), with no difference in dislocation rate between groups (1.03% vs 0.68%; odds ratio, 0.658; 95% confidence interval, 0.11-3.96; P = .647).","['Between January 2016 and April 2019, 587 patients (594 hips']",['hip precautions'],"['incidence of early dislocation', 'difficulty with activities of daily living, earlier return to driving, and more time spent side sleeping', 'posterior dislocations', 'dislocation rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1265659', 'cui_str': 'Posterior dislocation'}]",,0.0516959,"Three posterior dislocations occurred in the restricted group at a mean of 32 days (range, 17-47), and 2 posterior dislocations occurred in the unrestricted group at a mean of 112 days (range, 21-203), with no difference in dislocation rate between groups (1.03% vs 0.68%; odds ratio, 0.658; 95% confidence interval, 0.11-3.96; P = .647).","[{'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Tetreault', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois; Division of Orthopaedic Surgery, Department of Surgery, Albany Medical Center, Albany, New York; The Bone & Joint Center, Albany, New York.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Akram', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Nam', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Tad L', 'Initials': 'TL', 'LastName': 'Gerlinger', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Della Valle', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Levine', 'Affiliation': 'Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.02.019']
1046,31263284,Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study.,"Metabolic syndrome is characterized by a constellation of comorbidities that predispose individuals to an increased risk of developing cardiovascular pathologies as well as type 2 diabetes mellitus 1 . The gut microbiota is a new key contributor involved in the onset of obesity-related disorders 2 . In humans, studies have provided evidence for a negative correlation between Akkermansia muciniphila abundance and overweight, obesity, untreated type 2 diabetes mellitus or hypertension 3-8 . Since the administration of A. muciniphila has never been investigated in humans, we conducted a randomized, double-blind, placebo-controlled pilot study in overweight/obese insulin-resistant volunteers; 40 were enrolled and 32 completed the trial. The primary end points were safety, tolerability and metabolic parameters (that is, insulin resistance, circulating lipids, visceral adiposity and body mass). Secondary outcomes were gut barrier function (that is, plasma lipopolysaccharides) and gut microbiota composition. In this single-center study, we demonstrated that daily oral supplementation of 10 10  A. muciniphila bacteria either live or pasteurized for three months was safe and well tolerated. Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02). Pasteurized A. muciniphila supplementation slightly decreased body weight (-2.27 ± 0.92 kg, P = 0.091) compared to the placebo group, and fat mass (-1.37 ± 0.82 kg, P = 0.092) and hip circumference (-2.63 ± 1.14 cm, P = 0.091) compared to baseline. After three months of supplementation, A. muciniphila reduced the levels of the relevant blood markers for liver dysfunction and inflammation while the overall gut microbiome structure was unaffected. In conclusion, this proof-of-concept study (clinical trial no. NCT02637115 ) shows that the intervention was safe and well tolerated and that supplementation with A. muciniphila improves several metabolic parameters.",2019,"Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02).","['overweight/obese insulin-resistant volunteers; 40 were enrolled and 32 completed the trial', 'overweight and obese human volunteers']","['placebo', 'Akkermansia muciniphila']","['safe and well tolerated', 'insulin sensitivity', 'reduced insulinemia', 'several metabolic parameters', 'body weight', 'fat mass', 'gut barrier function (that is, plasma lipopolysaccharides) and gut microbiota composition', 'hip circumference', 'safety, tolerability and metabolic parameters (that is, insulin resistance, circulating lipids, visceral adiposity and body mass', 'levels of the relevant blood markers for liver dysfunction and inflammation', 'plasma total cholesterol']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1490590', 'cui_str': 'Akkermansia muciniphila'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",40.0,0.293433,"Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02).","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Depommier', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Everard', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Druart', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Plovier', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Van Hul', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vieira-Silva', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Falony', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Raes', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Maiter', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Delzenne', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'de Barsy', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Loumaye', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Michel P', 'Initials': 'MP', 'LastName': 'Hermans', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Thissen', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Willem M', 'Initials': 'WM', 'LastName': 'de Vos', 'Affiliation': 'Laboratory of Microbiology, Wageningen University, Wageningen, the Netherlands.'}, {'ForeName': 'Patrice D', 'Initials': 'PD', 'LastName': 'Cani', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium. Patrice.cani@uclouvain.be.'}]",Nature medicine,['10.1038/s41591-019-0495-2']
1047,31113932,ABCB1 SNP predicts outcome in patients with acute myeloid leukemia treated with Gemtuzumab ozogamicin: a report from Children's Oncology Group AAML0531 Trial.,"Gemtuzumab-ozogamicin (GO), a humanized-anti-CD33 antibody linked with the toxin-calicheamicin-γ is a reemerging and promising drug for AML. Calicheamicin a key element of GO, induces DNA-damage and cell-death once the linked CD33-antibody facilitates its uptake. Calicheamicin efflux by the drug-transporter PgP-1 have been implicated in GO response thus in this study, we evaluated impact of ABCB1-SNPs on GO response. Genomic-DNA samples from 942 patients randomized to receive standard therapy with or without addition of GO (COG-AAML0531) were genotyped for ABCB1-SNPs. Our most interesting results show that for rs1045642, patients with minor-T-allele (CT/TT) had better outcome as compared to patients with CC genotype in GO-arm (Event-free survival-EFS: p = 0.022; and risk of relapse-RR, p = 0.007). In contrast, no difference between genotypes was observed for any of the clinical endpoints within No-GO arm (all p > 0.05). Consistent results were obtained when genotype groups were compared by GO and No-GO arms. The in vitro evaluation using HL60-cells further demonstrated consistent impact of rs1045642-T-allele on calicheamicin induced DNA-damage and cell-viability. Our results show the significance of ABCB1 SNPs on GO response in AML and warrants the need to investigate this in other cohorts. Once validated, ABCB1-SNPs in conjunction with CD33-SNPs can open up opportunities to personalize GO-therapy.",2019,"In contrast, no difference between genotypes was observed for any of the clinical endpoints within No-GO arm (all p > 0.05).","['patients with acute myeloid leukemia treated with', '942 patients randomized to receive']","['Gemtuzumab-ozogamicin (GO', 'ABCB1 SNP', 'standard therapy with or without addition of GO (COG-AAML0531', 'Gemtuzumab ozogamicin']",['GO response'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1533699', 'cui_str': 'Gemtuzumab ozogamicin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],942.0,0.0263351,"In contrast, no difference between genotypes was observed for any of the clinical endpoints within No-GO arm (all p > 0.05).","[{'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Rafiee', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, Center for Pharmacogenomics, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Lata', 'Initials': 'L', 'LastName': 'Chauhan', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, Center for Pharmacogenomics, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Alonzo', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Yi-Cheng', 'Initials': 'YC', 'LastName': 'Wang', 'Affiliation': ""Children's Oncology Group, Monrovia, CA, USA.""}, {'ForeName': 'Ahlam', 'Initials': 'A', 'LastName': 'Elmasry', 'Affiliation': 'Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Loken', 'Affiliation': 'Hematologics Inc, Seattle, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Pollard', 'Affiliation': ""Dana-Farber/Boston Children's Cancer Center and Blood Disorders Center, Boston, MA, USA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Aplenc', 'Affiliation': ""Division of Oncology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Raimondi', 'Affiliation': ""Department of Pathology, St. Jude Children's Hospital, Memphis, TN, USA.""}, {'ForeName': 'Betsy A', 'Initials': 'BA', 'LastName': 'Hirsch', 'Affiliation': ""Children's Hospitals and Clinic of Minnesota, University of Minnesota, Minneapolis, MN, USA.""}, {'ForeName': 'Irwin D', 'Initials': 'ID', 'LastName': 'Bernstein', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Gamis', 'Affiliation': ""Division of Hematology/Oncology/Bone Marrow Transplantation, Children's Mercy Hospitals and Clinics, Kansas City, MO, USA.""}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Meshinchi', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Jatinder K', 'Initials': 'JK', 'LastName': 'Lamba', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, Center for Pharmacogenomics, College of Pharmacy, University of Florida, Gainesville, FL, USA. jlamba@cop.ufl.edu.'}]",Blood cancer journal,['10.1038/s41408-019-0211-y']
1048,31065992,"Relative Oral Bioavailability of an Abuse-Deterrent, Immediate-Release Formulation of Oxycodone, Oxycodone ARIR in a Randomized Study.","INTRODUCTION


Oxycodone ARIR is a novel oral, abuse-deterrent, immediate-release (IR) formulation with physical and chemical properties that deter misuse and abuse by non-oral routes. In this single-dose pharmacokinetic study, we assessed the relative bioavailability of oxycodone for Oxycodone ARIR and IR oxycodone, and the effect of food on Oxycodone ARIR following oral administration.
METHODS


This open-label, randomized study in healthy adults compared the relative bioavailability of Oxycodone ARIR 30 mg to IR oxycodone 30 mg under fasted conditions, and Oxycodone ARIR under fed versus fasted conditions. Pharmacokinetic parameters included area under the concentration-time curve from time 0 to the last measured concentration (AUC 0-t ) and the maximum oxycodone plasma concentration (C max ). Equivalence was determined using an analysis of variance of the least-squares means.
RESULTS


Fifty-eight subjects completed the study. Under fasted conditions, AUC 0-t  was 4% lower (90% CI 92.5-98.7%) and mean C max  was 14% lower (90% CI 78.8-94.3%) for Oxycodone ARIR versus IR oxycodone. AUC 0-t  was 23% higher (90% CI 119.1-127.0%) and mean C max  was higher (90% CI 108.6-129.4%) when Oxycodone ARIR was administered in the fed versus fasted state. Common adverse events included nausea, headache, and dizziness.
CONCLUSION


In this single-dose pharmacokinetic evaluation, fasted Oxycodone ARIR 30 mg had similar bioavailability to and is expected to have the same efficacy and safety profile as IR oxycodone. When administered in the fed state, pharmacokinetic parameters were slightly higher; however, these differences were considered not clinically meaningful and show that Oxycodone ARIR can be administered with or without food.
FUNDING


This study was funded by Inspirion Delivery Sciences, LLC. Daiichi Sankyo, Inc. funded the journal's article processing charges and open access fee. Plain language summary available for this article.",2019,AUC 0-t  was 23% higher (90% CI 119.1-127.0%) and mean C max  was higher (90% CI 108.6-129.4%) when Oxycodone ARIR was administered in the fed versus fasted state.,"['Fifty-eight subjects completed the study', 'healthy adults']","['oxycodone', 'Oxycodone ARIR', 'Oxycodone ARIR under fed versus fasted conditions', 'Oxycodone', 'ARIR', 'IR']","['AUC 0-t', 'Pharmacokinetic parameters included area under the concentration-time curve from time 0 to the last measured concentration (AUC 0-t ) and the maximum oxycodone plasma concentration (C max ', 'nausea, headache, and dizziness', 'mean C max']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0271561,AUC 0-t  was 23% higher (90% CI 119.1-127.0%) and mean C max  was higher (90% CI 108.6-129.4%) when Oxycodone ARIR was administered in the fed versus fasted state.,"[{'ForeName': 'Lynn R', 'Initials': 'LR', 'LastName': 'Webster', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA. lrwebstermd@gmail.com.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Kinzler', 'Affiliation': 'Inspirion Delivery Sciences LLC, Morristown, NJ, USA.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Pantaleon', 'Affiliation': 'Inspirion Delivery Sciences LLC, Morristown, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Iverson', 'Affiliation': 'Inspirion Delivery Sciences LLC, Morristown, NJ, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Aigner', 'Affiliation': 'Inspirion Delivery Sciences LLC, Morristown, NJ, USA.'}]",Advances in therapy,['10.1007/s12325-019-00963-0']
1049,31158840,Effects of Bardoxolone Methyl on QT Interval in Healthy Volunteers.,"BACKGROUND


Bardoxolone methyl has been shown to increase eGFR in several clinical trials, including a phase 3 trial in patients with type 2 diabetes and stage 4 CKD (BEACON), which was terminated early due to an increase in heart failure events in bardoxolone methyl-treated patients. A separate, ""thorough QT"" study was conducted in parallel with BEACON to evaluate the cardiovascular safety of bardoxolone methyl in healthy subjects.
METHODS


Subjects in the ""thorough QT"" study were randomized to receive bardoxolone methyl 20 mg (therapeutic dose) or 80 mg (supratherapeutic dose), placebo, or moxifloxacin (400 mg; an active comparator). ECG results and supine blood pressure measurements were analyzed. The effects of bardoxolone methyl on QT interval changes from baseline were quantified compared to the effect of placebo by calculating mean, time-matched, placebo-corrected, baseline-adjusted QTcF values (ΔΔQTcF) after 6 days of daily administration of bardoxolone methyl.
RESULTS


The study was halted early due to emerging safety information from the BEACON trial; however, 142/179 patients received all doses of the study drug and completed the study. For both bardoxolone methyl-treated groups (20 and 80 mg), the upper limits of the 2-sided 90% confidence interval for ΔΔQTcF were less than the significance limit (10 ms) at all time points. Changes in blood pressure were similar in all treatment groups, and no serious adverse events were reported.
CONCLUSIONS


In healthy subjects, treatment with 20 or 80 mg bardoxolone methyl did not affect the QTcF interval.",2019,"In healthy subjects, treatment with 20 or 80 mg bardoxolone methyl did not affect the QTcF interval.","['healthy subjects', 'Healthy Volunteers', 'Subjects in the ""thorough QT"" study', '142/179 patients received all doses of the study drug and completed the study', 'patients with type 2 diabetes and stage 4 CKD (BEACON']","['Bardoxolone methyl', 'Bardoxolone Methyl', 'bardoxolone methyl', 'placebo', 'bardoxolone methyl 20 mg (therapeutic dose) or 80 mg (supratherapeutic dose), placebo, or moxifloxacin']","['QTcF interval', 'QT Interval', 'blood pressure', 'ECG results and supine blood pressure measurements', 'QT interval changes', 'heart failure events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}]","[{'cui': 'C1100924', 'cui_str': 'methyl 2-cyano-3,12-dioxoolean-1,9-dien-28-oate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.149714,"In healthy subjects, treatment with 20 or 80 mg bardoxolone methyl did not affect the QTcF interval.","[{'ForeName': 'Melanie P', 'Initials': 'MP', 'LastName': 'Chin', 'Affiliation': 'Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Rich', 'Affiliation': 'Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'Angie', 'Initials': 'A', 'LastName': 'Goldsberry', 'Affiliation': 'Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'O Apos Grady', 'Affiliation': 'Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Meyer', 'Affiliation': 'Product Development, Reata Pharmaceuticals, Irving, Texas, USA, colin.meyer@reatapharma.com.'}]",Cardiorenal medicine,['10.1159/000500736']
1050,30477333,Implementation of Occupational Sun Safety at a 2-Year Follow-Up in a Randomized Trial: Comparison of Sun Safe Workplaces Policy Intervention to Attention Control.,"PURPOSE


Implementation of employer sun safety actions was assessed in a 2-year follow-up to an occupational sun protection policy intervention.
DESIGN


Two-year follow-up assessment in a randomized pretest-posttest controlled design.
SETTING


Local government organizations with workers in public safety, public works, and parks and recreation.
PARTICIPANTS


Sixty-three local government organizations (participation = 64%) and 330 frontline supervisors and 1454 workers.
INTERVENTION


Sun Safe Workplaces (SSW) intervention promoting occupational sun safety policy and education.
MEASURES


Observations of SSW messages and sun safety items and surveys on organizations' communication and actions on sun safety.
ANALYSIS


Comparison between SSW and control groups was conducted using regression models and adjusted for clustering where appropriate, with α criterion set at P = .05 (2-tailed).
RESULTS


At intervention worksites, more SSW messages ( P < .001) and sun safety items ( P = .025) were observed; more frontline supervisors reported organizations provided free/reduced price sunscreen ( P = .005) and communicated about sun safety ( P < .001); and more workers recalled receiving sun safety messages ( P < .001) and sun safety training ( P <.001) compared to control organizations. Implementation was greater at larger than smaller intervention organizations for wide-brimmed hats ( P = .009), long work pants ( P = .017), and shade structures ( P = .036). Older workers received the most written messages ( P = .015).
CONCLUSIONS


Sun Safe Workplaces appeared to produce actions by organizations to support employee sun safety. Large organizations may have processes, communication channels, and slack resources to achieve more implementation.",2019,"Implementation was greater at larger than smaller intervention organizations for wide-brimmed hats ( P = .009), long work pants ( P = .017), and shade structures ( P = .036).","['Local government organizations with workers in public safety, public works, and parks and recreation', 'Older workers', 'Sixty-three local government organizations (participation = 64%) and 330 frontline supervisors and 1454 workers']","['Sun Safe Workplaces (SSW) intervention promoting occupational sun safety policy and education', 'Sun Safe Workplaces Policy Intervention']","['price sunscreen', 'SSW messages', 'sun safety training', 'sun safety', 'sun safety items', ""SSW messages and sun safety items and surveys on organizations' communication and actions on sun safety""]","[{'cui': 'C0026788', 'cui_str': 'Local Government'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0562547', 'cui_str': 'Park (environment)'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0403172', 'cui_str': 'Supervisor (occupation)'}]","[{'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}]","[{'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]",,0.0351092,"Implementation was greater at larger than smaller intervention organizations for wide-brimmed hats ( P = .009), long work pants ( P = .017), and shade structures ( P = .036).","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': '1 Klein Buendel, Inc, Lakewood, CA, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Walkosz', 'Affiliation': '1 Klein Buendel, Inc, Lakewood, CA, USA.'}, {'ForeName': 'Mary Klein', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': '1 Klein Buendel, Inc, Lakewood, CA, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Wallis', 'Affiliation': '2 School of Public Affairs, University of Colorado Denver, Denver, CO, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Andersen', 'Affiliation': '3 School of Communication, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Scott', 'Affiliation': '4 Mikonics, Inc, Santa Fe, NM, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Meenan', 'Affiliation': '5 Kaiser Permanente, Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': '6 Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117118814398']
1051,30475764,Systematic Multi-Domain Alzheimer's Risk Reduction Trial (SMARRT): Study Protocol.,"This article describes the protocol for the Systematic Multi-domain Alzheimer's Risk Reduction Trial (SMARRT), a single-blind randomized pilot trial to test a personalized, pragmatic, multi-domain Alzheimer's disease (AD) risk reduction intervention in a US integrated healthcare delivery system. Study participants will be 200 higher-risk older adults (age 70-89 years with subjective cognitive complaints, low normal performance on cognitive screen, and ≥ two modifiable risk factors targeted by our intervention) who will be recruited from selected primary care clinics of Kaiser Permanente Washington, oversampling people with non-white race or Hispanic ethnicity. Study participants will be randomly assigned to a two-year Alzheimer's risk reduction intervention (SMARRT) or a Health Education (HE) control. Randomization will be stratified by clinic, race/ethnicity (non-Hispanic white versus non-white or Hispanic), and age (70-79, 80-89). Participants randomized to the SMARRT group will work with a behavioral coach and nurse to develop a personalized plan related to their risk factors (poorly controlled hypertension, diabetes with evidence of hyper or hypoglycemia, depressive symptoms, poor sleep quality, contraindicated medications, physical inactivity, low cognitive stimulation, social isolation, poor diet, smoking). Participants in the HE control group will be mailed general health education information about these risk factors for AD. The primary outcome is two-year cognitive change on a cognitive test composite score. Secondary outcomes include: 1) improvement in targeted risk factors, 2) individual cognitive domain composite scores, 3) physical performance, 4) functional ability, 5) quality of life, and 6) incidence of mild cognitive impairment, AD, and dementia. Primary and secondary outcomes will be assessed in both groups at baseline and 6, 12, 18, and 24 months.",2019,Study participants will be randomly assigned to a two-year Alzheimer's risk reduction intervention (SMARRT) or a Health Education (HE) control.,"['race/ethnicity (non-Hispanic white versus non-white or Hispanic), and age (70-79, 80-89', '200 higher-risk older adults (age 70-89 years with subjective cognitive complaints, low normal performance on cognitive screen, and ≥ two modifiable risk factors targeted by our intervention) who will be recruited from selected primary care clinics of Kaiser Permanente Washington, oversampling people with non-white race or Hispanic ethnicity']","[""Alzheimer's risk reduction intervention (SMARRT) or a Health Education (HE) control"", 'SMARRT', ""Systematic Multi-Domain Alzheimer's Risk Reduction Trial (SMARRT"", 'behavioral coach and nurse to develop a personalized plan related to their risk factors (poorly controlled hypertension, diabetes with evidence of hyper or hypoglycemia, depressive symptoms, poor sleep quality, contraindicated medications, physical inactivity, low cognitive stimulation, social isolation, poor diet, smoking']","[' 1) improvement in targeted risk factors, 2) individual cognitive domain composite scores, 3) physical performance, 4) functional ability, 5) quality of life, and 6) incidence of mild cognitive impairment, AD, and dementia', 'two-year cognitive change on a cognitive test composite score']","[{'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0018701'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation (regime/therapy)'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2607857'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",200.0,0.0662595,Study participants will be randomly assigned to a two-year Alzheimer's risk reduction intervention (SMARRT) or a Health Education (HE) control.,"[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Yaffe', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Deborah E', 'Initials': 'DE', 'LastName': 'Barnes', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Dori', 'Initials': 'D', 'LastName': 'Rosenberg', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Dublin', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Allison R', 'Initials': 'AR', 'LastName': 'Kaup', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Evette J', 'Initials': 'EJ', 'LastName': 'Ludman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Carrie B', 'Initials': 'CB', 'LastName': 'Peltz', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA.'}, {'ForeName': 'Anne D', 'Initials': 'AD', 'LastName': 'Renz', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Kristin J', 'Initials': 'KJ', 'LastName': 'Adams', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Larson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-180634']
1052,32141476,"Enhancing adherence to antipsychotic treatment for bipolar disorders. Comparison of mobile app-based psychoeducation, group psychoeducation, and the combination of both: protocol of a three-arm single-blinded parallel-group multi-centre randomised trial.","Group Psychoeducation (PE) is an effective strategy to enhance adherence to antipsychotic treatment in Bipolar Disorders (BD). However, it requires attendance to weekly sessions during a period of about 6 months. This may impede its application for those patients living far from mental health centres, resulting inequality in access to evidence-based care. Therefore, there is an increasing need to find new efficient strategies to deliver and extend PE programs to a wider population of BD patients. Mobile apps are a cost-effective way to deliver PE. In the Italian healthcare context, no evidence about the use of apps is available. The current paper presents the protocol about the development of a smartphone app to deliver PE for BD and the protocol for a trial assessing its effectiveness. In euthymic BD patients, the study will compare the adherence rates to antipsychotics between PE delivered through Bipolar mobile Application (Bip.App), group PE and a combination of both, will investigate demographic, socio-cultural and clinical predictors of lower adherence in the arms, and will investigate whether PE combined with Bip.App is associated with lower risk of recurrence of (hypo)manic and depressive episodes than group PE alone, and assess the feasibility and satisfaction for Bip.App. Participants will be recruited from mental health centres and included if they are 18-65 year-old, have primary BD in the euthymic phase, they have been prescribed a second-generation oral antipsychotic as a maintenance/prophylactic therapy for at least 1 year, they have not undergone a structured protocol of PE for BD, they have access to a smartphone and sufficient competence in using it. Participants will be excluded if they have neurological disease, mental retardation or learning disability, psychosis, limited fluency in Italian. Adherence will be assessed through count pills, blood levels, and self-reported adherence. A single-blinded parallel-group superiority multi-centre randomised controlled trial design will be used.",2020,Group Psychoeducation (PE) is an effective strategy to enhance adherence to antipsychotic treatment in Bipolar Disorders (BD).,"['bipolar disorders', 'patients living far from mental health centres', 'Participants will be recruited from mental health centres and included if they are 18-65 year-old, have primary BD in the euthymic phase, they have been prescribed a second-generation oral antipsychotic as a maintenance/prophylactic therapy for at least 1 year', 'Participants will be excluded if they have neurological disease, mental retardation or learning disability, psychosis, limited fluency in Italian']","['Group Psychoeducation (PE', 'PE combined with Bip', 'mobile app-based psychoeducation']","['adherence rates', 'lower risk of recurrence of (hypo)manic and depressive episodes', 'feasibility and satisfaction for Bip', 'count pills, blood levels, and self-reported adherence']","[{'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",,0.275793,Group Psychoeducation (PE) is an effective strategy to enhance adherence to antipsychotic treatment in Bipolar Disorders (BD).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pozza', 'Affiliation': 'Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Coluccia', 'Affiliation': 'Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gualtieri', 'Affiliation': 'Legal Medicine Unit, Santa Maria alle Scotte University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ferretti', 'Affiliation': 'Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena.'}]",La Clinica terapeutica,['10.7417/CT.2020.2194']
1053,31742629,Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Cesarean Delivery: A Randomized Clinical Trial.,"Importance


The American College of Obstetricians and Gynecologists recommends a delay in umbilical cord clamping in term neonates for at least 30 to 60 seconds after birth. Most literature supporting this practice is from low-risk vaginal deliveries. There are no published data specific to cesarean delivery.
Objective


To compare maternal blood loss with immediate cord clamping vs delayed cord clamping in scheduled cesarean deliveries at term (≥37 weeks).
Design, Setting, and Participants


Randomized clinical trial performed at 2 hospitals within a tertiary academic medical center in New York City from October 2017 to February 2018 (follow-up completed March 15, 2018). A total of 113 women undergoing scheduled cesarean delivery of term singleton gestations were included.
Interventions


In the immediate cord clamping group (n = 56), cord clamping was within 15 seconds after birth. In the delayed cord clamping group (n = 57), cord clamping was at 60 seconds after birth.
Main Outcomes and Measures


The primary outcome was change in maternal hemoglobin level from preoperative to postoperative day 1, which was used as a proxy for maternal blood loss. Secondary outcomes included neonatal hemoglobin level at 24 to 72 hours of life.
Results


All of the 113 women who were randomized (mean [SD] age, 32.6 [5.2] years) completed the trial. The mean preoperative hemoglobin level was 12.0 g/dL in the delayed and 11.6 g/dL in the immediate cord clamping group. The mean postoperative day 1 hemoglobin level was 10.1 g/dL in the delayed group and 9.8 g/dL in the immediate group. There was no significant difference in the primary outcome, with a mean hemoglobin change of -1.90 g/dL (95% CI, -2.14 to -1.66) and -1.78 g/dL (95% CI, -2.03 to -1.54) in the delayed and immediate cord clamping groups, respectively (mean difference, 0.12 g/dL [95% CI, -0.22 to 0.46]; P = .49). Of 19 prespecified secondary outcomes analyzed, 15 showed no significant difference. The mean neonatal hemoglobin level, available for 90 neonates (79.6%), was significantly higher with delayed (18.1 g/dL [95% CI, 17.4 to 18.8]) compared with immediate (16.4 g/dL [95% CI, 15.9 to 17.0]) cord clamping (mean difference, 1.67 g/dL [95% CI, 0.75 to 2.59]; P < .001). There was 1 unplanned hysterectomy in each group.
Conclusions and Relevance


Among women undergoing scheduled cesarean delivery of term singleton pregnancies, delayed umbilical cord clamping, compared with immediate cord clamping, resulted in no significant difference in the change in maternal hemoglobin level at postoperative day 1.
Trial Registration


ClinicalTrials.gov Identifier: NCT03150641.",2019,"There was no significant difference in the primary outcome, with a mean hemoglobin change of -1.90","['scheduled cesarean deliveries at term (≥37 weeks', 'women undergoing scheduled cesarean delivery of term singleton pregnancies', 'Term Cesarean Delivery', '113 women undergoing scheduled cesarean delivery of term singleton gestations were included', '2 hospitals within a tertiary academic medical center in New York City from October 2017 to February 2018 (follow-up completed March 15, 2018', '113 women who were randomized (mean [SD] age, 32.6 [5.2] years) completed the trial']","['immediate cord clamping vs delayed cord clamping', 'Delayed vs Immediate Umbilical Cord Clamping', 'dL']","['mean preoperative hemoglobin level', 'Maternal Blood Loss', 'maternal blood loss', 'mean hemoglobin change of -1.90', 'cord clamping', 'mean neonatal hemoglobin level', 'unplanned hysterectomy', 'delayed umbilical cord clamping', 'mean postoperative day 1 hemoglobin level', 'neonatal hemoglobin level at 24 to 72 hours of life', 'maternal hemoglobin level']","[{'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",113.0,0.360268,"There was no significant difference in the primary outcome, with a mean hemoglobin change of -1.90","[{'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Purisch', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Cande V', 'Initials': 'CV', 'LastName': 'Ananth', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Arditi', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Logan', 'Initials': 'L', 'LastName': 'Mauney', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Barouyr', 'Initials': 'B', 'LastName': 'Ajemian', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Heiderich', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Leone', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Gyamfi-Bannerman', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}]",JAMA,['10.1001/jama.2019.15995']
1054,31742630,Association of Umbilical Cord Milking vs Delayed Umbilical Cord Clamping With Death or Severe Intraventricular Hemorrhage Among Preterm Infants.,"Importance


Umbilical cord milking as an alternative to delayed umbilical cord clamping may provide equivalent benefits to preterm infants, but without delaying resuscitation.
Objective


To determine whether the rates of death or severe intraventricular hemorrhage differ among preterm infants receiving placental transfusion with umbilical cord milking vs delayed umbilical cord clamping.
Design, Setting, and Participants


Noninferiority randomized clinical trial of preterm infants (born at 23-31 weeks' gestation) from 9 university and private medical centers in 4 countries were recruited and enrolled between June 2017 and September 2018. Planned enrollment was 750 per group. However, a safety signal comprising an imbalance in the number of severe intraventricular hemorrhage events by study group was observed at the first interim analysis; enrollment was stopped based on recommendations from the data and safety monitoring board. The planned noninferiority analysis could not be conducted and a post hoc comparison was performed instead. Final date of follow-up was December 2018.
Interventions


Participants were randomized to umbilical cord milking (n = 236) or delayed umbilical cord clamping (n = 238).
Main Outcomes and Measures


The primary outcome was a composite of death or severe intraventricular hemorrhage to determine noninferiority of umbilical cord milking with a 1% noninferiority margin.
Results


Among 540 infants randomized, 474 (88%) were enrolled and completed the trial (mean gestational age of 28 weeks; 46% female). Twelve percent (29/236) of the umbilical cord milking group died or developed severe intraventricular hemorrhage compared with 8% (20/238) of the delayed umbilical cord clamping group (risk difference, 4% [95% CI, -2% to 9%]; P = .16). Although there was no statistically significant difference in death, severe intraventricular hemorrhage was statistically significantly higher in the umbilical cord milking group than in the delayed umbilical cord clamping group (8% [20/236] vs 3% [8/238], respectively; risk difference, 5% [95% CI, 1% to 9%]; P = .02). The test for interaction between gestational age strata and treatment group was significant for severe intraventricular hemorrhage only (P = .003); among infants born at 23 to 27 weeks' gestation, severe intraventricular hemorrhage was statistically significantly higher with umbilical cord milking than with delayed umbilical cord clamping (22% [20/93] vs 6% [5/89], respectively; risk difference, 16% [95% CI, 6% to 26%]; P = .002).
Conclusions and Relevance


In this post hoc analysis of a prematurely terminated randomized clinical trial of umbilical cord milking vs delayed umbilical cord clamping among preterm infants born at less than 32 weeks' gestation, there was no statistically significant difference in the rate of a composite outcome of death or severe intraventricular hemorrhage, but there was a statistically significantly higher rate of severe intraventricular hemorrhage in the umbilical cord milking group. The early study termination and resulting post hoc nature of the analyses preclude definitive conclusions.
Trial Registration


ClinicalTrials.gov Identifier: NCT03019367.",2019,"Although there was no statistically significant difference in death, severe intraventricular hemorrhage was statistically significantly higher in the umbilical cord milking group than in the delayed umbilical cord clamping group (8% [20/236] vs 3% [8/238], respectively; risk difference, 5% [95% CI, 1% to 9%]; P = .02).","['540 infants randomized, 474 (88%) were enrolled and completed the trial (mean gestational age of 28 weeks; 46% female', ""preterm infants born at less than 32 weeks' gestation"", ""preterm infants (born at 23-31 weeks' gestation) from 9 university and private medical centers in 4 countries were recruited and enrolled between June 2017 and September 2018"", 'Preterm Infants', 'preterm infants receiving']","['umbilical cord milking (n\u2009=\u2009236) or delayed umbilical cord clamping', 'umbilical cord milking vs delayed umbilical cord clamping', 'Umbilical Cord Milking vs Delayed Umbilical Cord', 'placental transfusion with umbilical cord milking vs delayed umbilical cord clamping']","['death, severe intraventricular hemorrhage', 'rate of a composite outcome of death or severe intraventricular hemorrhage', 'rates of death or severe intraventricular hemorrhage', 'Clamping With Death or Severe Intraventricular Hemorrhage', 'composite of death or severe intraventricular hemorrhage to determine noninferiority of umbilical cord milking with a 1% noninferiority margin', 'severe intraventricular hemorrhage']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}]",540.0,0.635657,"Although there was no statistically significant difference in death, severe intraventricular hemorrhage was statistically significantly higher in the umbilical cord milking group than in the delayed umbilical cord clamping group (8% [20/236] vs 3% [8/238], respectively; risk difference, 5% [95% CI, 1% to 9%]; P = .02).","[{'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Katheria', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Reister', 'Affiliation': 'Department of Obstetrics, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Essers', 'Affiliation': 'Department of Pediatrics, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Mendler', 'Affiliation': 'Department of Pediatrics, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hummler', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Sidra Medicine, Doha, Qatar.'}, {'ForeName': 'Akila', 'Initials': 'A', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Obstetrics, University of Alabama at Birmingham.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Tita', 'Affiliation': 'Department of Obstetrics, University of Alabama at Birmingham.'}, {'ForeName': 'Giang', 'Initials': 'G', 'LastName': 'Truong', 'Affiliation': 'Department of Pediatrics, Loma Linda University, Loma Linda, California.'}, {'ForeName': 'Shareece', 'Initials': 'S', 'LastName': 'Davis-Nelson', 'Affiliation': 'Department of Obstetrics, Loma Linda University, Loma Linda, California.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schmölzer', 'Affiliation': 'Department of Pediatrics, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Chari', 'Affiliation': 'Department of Obstetrics, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kaempf', 'Affiliation': ""Women and Children's Services, Providence St Vincent Medical Center, Portland, Oregon.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': ""Women and Children's Services, Providence St Vincent Medical Center, Portland, Oregon.""}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Yanowitz', 'Affiliation': ""Department of Pediatrics, Magee Women's Hospital of UPMC, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Beck', 'Affiliation': ""Department of Obstetrics, Magee Women's Hospital of UPMC, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Hyagriv', 'Initials': 'H', 'LastName': 'Simhan', 'Affiliation': ""Department of Obstetrics, Magee Women's Hospital of UPMC, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Dempsey', 'Affiliation': 'Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Keelin', 'Initials': 'K', 'LastName': ""O'Donoghue"", 'Affiliation': 'Department of Obstetrics, University College Cork, Cork, Ireland.'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Bhat', 'Affiliation': 'Department of Pediatrics, Christiana Care Health System, Newark, Delaware.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hoffman', 'Affiliation': 'Department of Obstetrics, Christiana Care Health System, Newark, Delaware.'}, {'ForeName': 'Arij', 'Initials': 'A', 'LastName': 'Faksh', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Arnell', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'Wade', 'Initials': 'W', 'LastName': 'Rich', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Finer', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Vaucher', 'Affiliation': ""Department of Radiology, Children's Hospital Colorado, University of Colorado School of Medicine, Denver.""}, {'ForeName': 'Paritosh', 'Initials': 'P', 'LastName': 'Khanna', 'Affiliation': ""Department of Radiology, Rady Children's Hospital, San Diego, California.""}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Meyers', 'Affiliation': ""Department of Radiology, Children's Hospital Colorado, University of Colorado School of Medicine, Denver.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Varner', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Allman', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Szychowski', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham.'}]",JAMA,['10.1001/jama.2019.16004']
1055,31438858,"Randomised, double-blind, placebo-controlled clinical trial for evaluating the efficacy of intracoronary injection of autologous bone marrow mononuclear cells in the improvement of the ventricular function in patients with idiopathic dilated myocardiopathy: a study protocol.","BACKGROUND


Cellular therapies have been increasingly applied to diverse human diseases. Intracoronary infusion of bone marrow-derived mononuclear cells (BMMNC) has demonstrated to improve ventricular function after acute myocardial infarction. However, less information is available about the role of BMMNC therapy for the treatment of dilated myocardiopathies (DCs) of non-ischemic origin. This article presents the methodological description of a study aimed at investigating the efficacy of intracoronary injection of autologous BMMNCs in the improvement of the ventricular function of patients with DC.
METHODS


This randomised, placebo-controlled, double-blinded phase IIb clinical trial compares the improvement on ventricular function (measured by the changes on the ejection fraction) of patients receiving the conventional treatment for DC in combination with a single dose of an intracoronary infusion of BMMNCs, with the functional recovery of patients receiving placebo plus conventional treatment. Patients assigned to both treatment groups are monitored for 24 months. This clinical trial is powered enough to detect a change in Left Ventricular Ejection Fraction (LVEF) equal to or greater than 9%, although an interim analysis is planned to re-calculate sample size.
DISCUSSION


The study protocol was approved by the Andalusian Coordinating Ethics Committee for Biomedical Research (Comité Coordinador de Ética en Investigación Biomédica de Andalucia), the Spanish Medicines and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios), and is registered at the EU Clinical Trials Register (EudraCT: 2013-002015-98). The publication of the trial results in scientific journals will be performed in accordance with the applicable regulations and guidelines to clinical trials.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT02033278 (First Posted January 10, 2014): https://clinicaltrials.gov/ct2/show/NCT02033278 ; EudraCT number: 2013-002015-98, EU CT Register: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002015-98 . Trial results will also be published according to the CONSORT statement at conferences and reported peer-reviewed journals.",2019,Intracoronary infusion of bone marrow-derived mononuclear cells (BMMNC) has demonstrated to improve ventricular function after acute myocardial infarction.,"['patients with idiopathic dilated myocardiopathy', 'patients with DC']","['placebo plus conventional treatment', 'placebo', 'intracoronary injection of autologous bone marrow mononuclear cells', 'Intracoronary infusion of bone marrow-derived mononuclear cells (BMMNC', 'intracoronary injection of autologous BMMNCs', 'https://clinicaltrials.gov/ct2/show/NCT02033278']","['Left Ventricular Ejection Fraction (LVEF', 'ventricular function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}]",,0.216057,Intracoronary infusion of bone marrow-derived mononuclear cells (BMMNC) has demonstrated to improve ventricular function after acute myocardial infarction.,"[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Romero', 'Affiliation': 'Cardiology Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Suárez-de-Lezo', 'Affiliation': 'Cardiology Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'Concha', 'Initials': 'C', 'LastName': 'Herrera', 'Affiliation': 'Cell Production Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pan', 'Affiliation': 'Cardiology Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'López-Aguilera', 'Affiliation': 'Cardiology Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Suárez-de-Lezo', 'Affiliation': 'Cardiology Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'Flor', 'Initials': 'F', 'LastName': 'Baeza-Garzón', 'Affiliation': 'Cardiology Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Hidalgo-Lesmes', 'Affiliation': 'Cardiology Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Fernández-López', 'Affiliation': 'Andalusian Initiative for Advanced Therapies, Andalusian Public Foundation Progress and Health - Junta de Andalucía, 41006, Esquina Avda. Hytasa, Seville, Spain.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Martínez-Atienza', 'Affiliation': 'Andalusian Initiative for Advanced Therapies, Andalusian Public Foundation Progress and Health - Junta de Andalucía, 41006, Esquina Avda. Hytasa, Seville, Spain. juliana.martinez@juntadeandalucia.es.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Cebrián', 'Affiliation': 'Cardiology Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Martín-Palanco', 'Affiliation': 'Cell Production Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Jiménez-Moreno', 'Affiliation': 'Cell Production Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Gutiérrez-Fernández', 'Affiliation': 'Cell Production Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Nogueras', 'Affiliation': 'Cell Production Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Carmona', 'Affiliation': 'Cell Production Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Ojeda', 'Affiliation': 'Cardiology Unit, Reina Sofía University Hospital, Córdoba, Spain.'}, {'ForeName': 'Natividad', 'Initials': 'N', 'LastName': 'Cuende', 'Affiliation': 'Andalusian Initiative for Advanced Therapies, Andalusian Public Foundation Progress and Health - Junta de Andalucía, 41006, Esquina Avda. Hytasa, Seville, Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Mata', 'Affiliation': 'Andalusian Initiative for Advanced Therapies, Andalusian Public Foundation Progress and Health - Junta de Andalucía, 41006, Esquina Avda. Hytasa, Seville, Spain.'}]",BMC cardiovascular disorders,['10.1186/s12872-019-1182-4']
1056,30397078,Effects and costs of implementing predictive risk stratification in primary care: a randomised stepped wedge trial.,"AIM


We evaluated the introduction of a predictive risk stratification model (PRISM) into primary care. Contemporaneously National Health Service (NHS) Wales introduced Quality and Outcomes Framework payments to general practices to focus care on those at highest risk of emergency admission to hospital. The aim of this study was to evaluate the costs and effects of introducing PRISM into primary care.
METHODS


Randomised stepped wedge trial with 32 general practices in one Welsh health board. The intervention comprised: PRISM software; practice-based training; clinical support through two 'general practitioner (GP) champions' and technical support. The primary outcome was emergency hospital admissions.
RESULTS


Across 230 099 participants, PRISM implementation increased use of health services: emergency hospital admission rates by 1 % when untransformed (while change in log-transformed rate Δ L =0.011, 95% CI 0.010 to 0.013); emergency department (ED) attendance rates by untransformed 3 % (while Δ L =0.030, 95% CI 0.028 to 0.032); outpatient visit rates by untransformed 5 % (while Δ L =0.055, 95% CI 0.051 to 0.058); the proportion of days with recorded GP activity by untransformed 1 % (while Δ L =0.011, 95% CI 0.007 to 0.014) and time in hospital by untransformed 3 % (while Δ L =0.029, 95% CI 0.026 to 0.031). Thus NHS costs per participant increased by £76 (95% CI £46 to £106).
CONCLUSIONS


Introduction of PRISM resulted in a statistically significant increase in emergency hospital admissions and use of other NHS services without evidence of benefits to patients or the NHS.",2019,"Across 230 099 participants, PRISM implementation increased use of health services: emergency hospital admission rates by 1 % when untransformed (while change in log-transformed rate Δ L =0.011, 95% CI 0.010 to 0.013); emergency department (ED) attendance rates by untransformed 3 % (while Δ L =0.030, 95% CI 0.028 to 0.032); outpatient visit rates by untransformed 5 % (while Δ L =0.055, 95% CI 0.051 to 0.058); the proportion of days with recorded GP activity by untransformed 1 % (while Δ L =0.011, 95% CI 0.007 to 0.014) and time in hospital by untransformed 3 % (while Δ L =0.029, 95% CI 0.026 to 0.031).","['primary care', '230 099 participants', '32 general practices in one Welsh health board']","['PRISM implementation', ""PRISM software; practice-based training; clinical support through two 'general practitioner (GP) champions' and technical support""]","['time in hospital', 'health services: emergency hospital admission rates', 'NHS costs per participant', 'proportion of days with recorded GP activity', 'outpatient visit rates', 'emergency department (ED) attendance rates', 'emergency hospital admissions']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0043114', 'cui_str': 'Welsh (ethnic group)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0184673', 'cui_str': 'Emergency hospital admission (procedure)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]",32.0,0.162459,"Across 230 099 participants, PRISM implementation increased use of health services: emergency hospital admission rates by 1 % when untransformed (while change in log-transformed rate Δ L =0.011, 95% CI 0.010 to 0.013); emergency department (ED) attendance rates by untransformed 3 % (while Δ L =0.030, 95% CI 0.028 to 0.032); outpatient visit rates by untransformed 5 % (while Δ L =0.055, 95% CI 0.051 to 0.058); the proportion of days with recorded GP activity by untransformed 1 % (while Δ L =0.011, 95% CI 0.007 to 0.014) and time in hospital by untransformed 3 % (while Δ L =0.029, 95% CI 0.026 to 0.031).","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Snooks', 'Affiliation': 'Medical School, Swansea University, Swansea, UK h.a.snooks@swansea.ac.uk.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Bailey-Jones', 'Affiliation': 'Abertawe Bro Morgannwg University Health Board, Neath Port Talbot, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Burge-Jones', 'Affiliation': 'Abertawe Bro Morgannwg University Health Board, Neath Port Talbot, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Dale', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Independent service user, Cardiff, UK.'}, {'ForeName': 'Bridie Angela', 'Initials': 'BA', 'LastName': 'Evans', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Farr', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Fitzsimmons', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heaven', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Howson', 'Affiliation': 'Bevan Commission, Swansea, UK.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Hutchings', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'John', 'Affiliation': 'NHS Wales Informatics Service, Cardiff, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kingston', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Lewis', 'Affiliation': 'International Foundation for Integrated Care, Oxford, UK.'}, {'ForeName': 'Ceri', 'Initials': 'C', 'LastName': 'Phillips', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Porter', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Sewell', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Warm', 'Affiliation': 'Hywel Dda University Health Board, Carmarthen, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Watkins', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Whitman', 'Affiliation': 'Independent service user, Cardiff, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Williams', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Russell', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}]",BMJ quality & safety,['10.1136/bmjqs-2018-007976']
1057,30753642,Tenofovir Gel for Prevention of Herpes Simplex Virus Type 2 Acquisition: Findings From the VOICE Trial.,"BACKGROUND


Genital infection with herpes simplex virus type 2 (HSV-2) is common and increases risk of human immunodeficiency virus (HIV) transmission and acquisition. Pericoital use of tenofovir (TFV) gel provided protection from HSV-2 acquisition in the CAPRISA 004 study.
METHODS


We measured estimate of effect of vaginal TFV 1% gel in preventing HSV-2 acquisition among women in VOICE, randomized, double-blinded, placebo-controlled trial assessing daily use of oral and vaginal TFV for HIV-1 preexposure prophylaxis. The TFV level in plasma at the first quarterly visit was used as a measure of gel use.
RESULTS


Of 566 participants at risk for HSV-2 acquisition, 532 (94%) had first-quarter plasma TFV and end-of-study HSV-2 serologic data available. Over a follow-up period of 501 person-years, 92 incident cases of HSV-2 acquisition occurred: 77 were in women with no TFV detected in plasma, and 15 occurred in women with TFV detected in plasma (incidence, 20.6 cases/100 person-years [95% confidence interval [CI], 16.2-25.7] vs 11.9 cases/100 person-years [95% CI, 6.6-19.6], respectively). TFV detection in plasma was associated with a trend toward a reduced risk of HSV-2 seroconversion, with an unadjusted hazard ratio (HR) of 0.59 (95% CI, .34-1.02; P = .060) and a HR adjusted for site, age, having ≥2 male sex partners in the past 3 months, use of hormonal contraception, having anal sex in the past 3 months, and HIV status of 0.60 (95% CI, .33-1.08; P = .086).
CONCLUSIONS


Detection of TFV in plasma among TFV gel users was associated with a trend toward a reduced risk of HSV-2 acquisition, after controlling for sexual behavior and HIV-1 acquisition.",2019,"Pericoital use of tenofovir (TFV) gel provided protection from HSV-2 acquisition in the CAPRISA 004 study.
","['566 participants at risk for HSV-2 acquisition, 532 (94%) had first-quarter plasma TFV and end-of-study', 'women in VOICE']","['vaginal TFV 1% gel', 'Tenofovir Gel', 'tenofovir (TFV) gel', 'placebo']","['TFV level in plasma', 'risk of HSV-2 seroconversion', 'TFV detection in plasma', 'HSV-2 acquisition', 'risk of HSV-2 acquisition']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0019351', 'cui_str': 'Human Herpesvirus 2'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019351', 'cui_str': 'Human Herpesvirus 2'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",566.0,0.511931,"Pericoital use of tenofovir (TFV) gel provided protection from HSV-2 acquisition in the CAPRISA 004 study.
","[{'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Marrazzo', 'Affiliation': 'University of Alabama-Birmingham.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Rabe', 'Affiliation': 'Magee-Womens Research Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Barbra', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Deal', 'Affiliation': 'Division of Microbiology and Infectious Disease, Bethesda.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Schwartz', 'Affiliation': 'CONRAD/Eastern Virginia Medical School, Arlington.'}, {'ForeName': 'Z M', 'Initials': 'ZM', 'LastName': 'Chirenje', 'Affiliation': 'University of Zimbabwe-University of California San Francisco Research Program, Harare, Zimbabwe.'}, {'ForeName': 'Jeanna', 'Initials': 'J', 'LastName': 'Piper', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.'}, {'ForeName': 'Rhoda Ashley', 'Initials': 'RA', 'LastName': 'Morrow', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'Magee-Womens Research Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiz045']
1058,31049266,Testing a Talkstory Intervention to create Supportive and Safe Violence-Free Communities for Women.,"The purpose of this paper is to report on a community-designed and led talkstory intervention to increase awareness of intimate partner violence (IPV), decrease acceptability of IPV, and increase community leadership to address IPV. In collaboration with women engaged in prior IPV outreach and education in Hawai'i, a talkstory intervention for IPV was developed, and a single-group, pre-post-test design was used to test it. The intervention included five talkstory sessions over seven months with community groups interested in violence prevention. Pre- and post-testing were conducted to determine changes in group means on three measures. Ninety-two individuals participated in the intervention, 77 (84%) of these completed the 1-month follow-up measure, and 59 (64%) of these also completed the 6-month follow-up measure. The findings included: (1) participants in the talkstory intervention groups decreased their acceptability of violence and increased their awareness, knowledge, and confidence to address IPV; (2) the community leaders in the intervention groups gained skills in facilitation; and (3) intervention groups continued to sponsor other IPV awareness-raising activities in their communities following completion of the study. Working with community leaders to design and facilitate the intervention not only provided IPV education within the context of the community, but also led to sustainable efforts to enhance the safety and wellbeing of women experiencing violence.",2019,"The findings included: (1) participants in the talkstory intervention groups decreased their acceptability of violence and increased their awareness, knowledge, and confidence to address IPV; (2) the community leaders in the intervention groups gained skills in facilitation; and (3) intervention groups continued to sponsor other IPV awareness-raising activities in their communities following completion of the study.","['women experiencing violence', 'Ninety-two individuals participated in the intervention, 77 (84%) of these completed the 1-month follow-up measure, and 59 (64%) of these also completed the 6-month follow-up measure', 'Women']","['talkstory intervention', 'Talkstory Intervention']","['acceptability of violence and increased their awareness, knowledge, and confidence to address IPV', 'awareness of intimate partner violence (IPV']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",92.0,0.0149864,"The findings included: (1) participants in the talkstory intervention groups decreased their acceptability of violence and increased their awareness, knowledge, and confidence to address IPV; (2) the community leaders in the intervention groups gained skills in facilitation; and (3) intervention groups continued to sponsor other IPV awareness-raising activities in their communities following completion of the study.","[{'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Magnussen', 'Affiliation': ""School of Nursing and Dental Hygiene, University of Hawai'i at Manoa, Honolulu, HI (LM, JS, Professors Emeriti).""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Shoultz', 'Affiliation': ""School of Nursing and Dental Hygiene, University of Hawai'i at Manoa, Honolulu, HI (LM, JS, Professors Emeriti).""}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Iannce-Spencer', 'Affiliation': ""School of Nursing and Dental Hygiene, University of Hawai'i at Manoa, Honolulu, HI (LM, JS, Professors Emeriti).""}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Braun', 'Affiliation': ""School of Nursing and Dental Hygiene, University of Hawai'i at Manoa, Honolulu, HI (LM, JS, Professors Emeriti).""}]",Hawai'i journal of medicine & public health : a journal of Asia Pacific Medicine & Public Health,[]
1059,30707761,"Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial.","BACKGROUND


The adjuvanted recombinant zoster vaccine (RZV) has demonstrated >90% efficacy against herpes zoster in adults ≥50 years of age and 68% efficacy in autologous hematopoietic stem cell transplant recipients ≥18 years of age. We report the immunogenicity and safety of RZV administered to patients with solid tumors (STs) before or at the start of a chemotherapy cycle.
METHOD


In this phase 2/3 observer-blind, multicenter study (NCT01798056), patients with STs who were ≥18 years of age were randomized (1:1) to receive 2 doses of RZV or placebo 1-2 months apart and stratified (4:1) according to the timing of the first dose with respect to the start of a chemotherapy cycle (first vaccination 8-30 days before the start or at the start [±1 day] of a chemotherapy cycle). Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 +  T cell frequencies, and vaccine response rates (VRRs) were assessed 1 month after dose 1 and 1 and 12 months after dose 2. Reactogenicity and safety were assessed in the total vaccinated cohort through 12 months after dose 2.
RESULTS


There were 232 participants in the total vaccinated cohort, 185 participants in the according-to-protocol cohort for humoral immunogenicity, and 58 participants in the according-to-protocol cohort for cell-mediated immunogenicity. Postvaccination anti-gE antibody concentrations, gE-specific CD4 +  T cell frequencies and VRRs were higher in RZV recipients than in placebo recipients. Solicited adverse events (AEs) were more frequent among RZV recipients than placebo recipients. Incidence of unsolicited AEs, serious AEs, fatalities, and potential immune-mediated diseases were similar between RZV and placebo recipients.
CONCLUSION


RZV was immunogenic in patients with STs receiving immunosuppressive chemotherapies. Humoral and cell-mediated immune responses persisted 1 year after vaccination. No safety concerns were identified.",2019,"Incidence of unsolicited AEs, serious AEs, fatalities, and potential immune-mediated diseases were similar between RZV and placebo recipients.
","['patients with STs receiving immunosuppressive chemotherapies', 'patients with STs who were ≥18 years of age', 'adults ≥50 years of age and 68% efficacy in autologous hematopoietic stem cell transplant recipients ≥18 years of age', '232 participants in the total vaccinated cohort, 185 participants in the according-to-protocol cohort for humoral immunogenicity, and 58 participants in the according-to-protocol cohort for cell-mediated immunogenicity', 'patients with solid tumors (STs) before or at the start of a chemotherapy cycle', 'patients with solid tumors, vaccinated before or during chemotherapy']","['RZV', 'RZV or placebo', 'adjuvanted recombinant zoster vaccine', 'recombinant zoster vaccine (RZV']","['Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 +  T cell frequencies, and vaccine response rates (VRRs', 'Postvaccination anti-gE antibody concentrations, gE-specific CD4 +  T cell frequencies and VRRs', 'Reactogenicity and safety', 'immunogenicity and safety', 'Incidence of unsolicited AEs, serious AEs, fatalities, and potential immune-mediated diseases', 'Solicited adverse events (AEs', 'Immunogenicity and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle (procedure)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",232.0,0.276458,"Incidence of unsolicited AEs, serious AEs, fatalities, and potential immune-mediated diseases were similar between RZV and placebo recipients.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vink', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Delgado Mingorance', 'Affiliation': 'Hospital Infanta Cristina, Badajoz, Spain.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Maximiano Alonso', 'Affiliation': 'Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Rubio-Viqueira', 'Affiliation': 'Hospital Universitario Quiron Madrid, Pozuelo de Alarcón, Spain.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Rodriguez Moreno', 'Affiliation': 'Centro Integral Oncologico Clara Campal, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Grande', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Marrupe Gonzalez', 'Affiliation': 'Hospital Universitario de Mostoles, Madrid, Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lowndes', 'Affiliation': 'Great Western Hospital, Swindon, United Kingdom.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Puente', 'Affiliation': 'Medical Oncology Department, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Kristeleit', 'Affiliation': 'Queen Elizabeth Hospital, Woolwich, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrugia', 'Affiliation': 'Cheltenham General Hospital, Gloucestershire, United Kingdom.'}, {'ForeName': 'Shelly A', 'Initials': 'SA', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Campora', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Di Paolo', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Idrissi', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Godeaux', 'Affiliation': 'Novadip Biosciences s.a., Mont-Saint-Guibert, Belgium.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'López-Fauqued', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Salaun', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Heineman', 'Affiliation': 'GSK, King of Prussia, Pennsylvania.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cancer,['10.1002/cncr.31909']
1060,31120534,Association of Black Race With Prostate Cancer-Specific and Other-Cause Mortality.,"Importance


Black men are more likely to die of prostate cancer than white men. In men with similar stages of disease, the contribution of biological vs nonbiological differences to this observed disparity is unclear.
Objective


To quantify the association of black race with long-term survival outcomes after controlling for known prognostic variables and access to care among men with prostate cancer.
Design, Setting, and Participants


This multiple-cohort study included updated individual patient-level data of men with clinical T1-4N0-1M0 prostate cancer from the following 3 cohorts: Surveillance, Epidemiology, and End Results (SEER [n = 296 273]); 5 equal-access regional medical centers within the Veterans Affairs health system (VA [n = 3972]); and 4 pooled National Cancer Institute-sponsored Radiation Therapy Oncology Group phase 3 randomized clinical trials (RCTs [n = 5854]). Data were collected in the 3 cohorts from January 1, 1992, through December 31, 2013, and analyzed from April 27, 2017, through April 13, 2019.
Exposures


In the VA and RCT cohorts, all patients received surgery and radiotherapy, respectively, with curative intent. In SEER, radical treatment, hormone therapy, or conservative management were received.
Main Outcomes and Measures


Prostate cancer-specific mortality (PCSM). Secondary measures included other-cause mortality (OCM). To adjust for demographic-, cancer-, and treatment-related baseline differences, inverse probability weighting (IPW) was performed.
Results


Among the 306 100 participants included in the analysis (mean [SD] age, 64.9 [8.9] years), black men constituted 52 840 patients (17.8%) in the SEER cohort, 1513 (38.1%) in the VA cohort, and 1129 (19.3%) in the RCT cohort. Black race was associated with an increased age-adjusted PCSM hazard (subdistribution hazard ratio [sHR], 1.30; 95% CI, 1.23-1.37; P < .001) within the SEER cohort. After IPW adjustment, black race was associated with a 0.5% (95% CI, 0.2%-0.9%) increase in PCSM at 10 years after diagnosis (sHR, 1.09; 95% CI, 1.04-1.15; P < .001), with no significant difference for high-risk men (sHR, 1.04; 95% CI, 0.97-1.12; P = .29). No significant differences in PCSM were found in the VA IPW cohort (sHR, 0.85; 95% CI, 0.56-1.30; P = .46), and black men had a significantly lower hazard in the RCT IPW cohort (sHR, 0.81; 95% CI, 0.66-0.99; P = .04). Black men had a significantly increased hazard of OCM in the SEER (sHR, 1.30; 95% CI, 1.27-1.34; P < .001) and RCT (sHR, 1.17; 95% CI, 1.06-1.29; P = .002) IPW cohorts.
Conclusions and Relevance


In this study, after adjustment for nonbiological differences, notably access to care and standardized treatment, black race did not appear to be associated with inferior stage-for-stage PCSM. A large disparity remained in OCM for black men with nonmetastatic prostate cancer.",2019,"No significant differences in PCSM were found in the VA IPW cohort (sHR, 0.85; 95% CI, 0.56-1.30; P = .46), and black men had a significantly lower hazard in the RCT IPW cohort (sHR, 0.81; 95% CI, 0.66-0.99; P = .04).","['Participants\n\n\nThis multiple-cohort study included updated individual patient-level data of men with clinical T1-4N0-1M0 prostate cancer from the following 3 cohorts: Surveillance, Epidemiology, and End Results (SEER [n\u2009', '3 cohorts from January 1, 1992, through December 31, 2013, and analyzed from April 27, 2017, through April 13, 2019', 'black men with nonmetastatic prostate cancer', 'men with prostate cancer', '306 100 participants included in the analysis (mean [SD] age, 64.9 [8.9] years), black men constituted\u200952\u202f840 patients (17.8%) in the SEER cohort, 1513 (38.1%) in the VA cohort, and 1129 (19.3%) in the RCT cohort', 'Importance\n\n\nBlack men', '296\u202f273]); 5 equal-access regional medical centers within the Veterans Affairs health system (VA [n\u2009=\u20093972]); and 4 pooled National Cancer Institute-sponsored Radiation Therapy Oncology Group phase 3 randomized clinical trials (RCTs [n\u2009=\u20095854']",['OCM'],"['black race', 'hazard of OCM', 'probability weighting (IPW', 'cause mortality (OCM', 'Measures\n\n\nProstate cancer-specific mortality (PCSM', 'PCSM', 'Black Race']","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]",[],"[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",306100.0,0.205254,"No significant differences in PCSM were found in the VA IPW cohort (sHR, 0.85; 95% CI, 0.56-1.30; P = .46), and black men had a significantly lower hazard in the RCT IPW cohort (sHR, 0.81; 95% CI, 0.66-0.99; P = .04).","[{'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Dess', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Hartman', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Mahal', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Payal D', 'Initials': 'PD', 'LastName': 'Soni', 'Affiliation': 'Department of Radiation Oncology, Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, Virginia.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Jackson', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Cooperberg', 'Affiliation': 'Department of Urology, University of California, San Francisco.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Amling', 'Affiliation': 'Department of Urology, Oregon Health and Science University, Portland.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Aronson', 'Affiliation': 'Department of Urology, University of California, Los Angeles.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Kane', 'Affiliation': 'Department of Urology, University of California, San Diego.'}, {'ForeName': 'Martha K', 'Initials': 'MK', 'LastName': 'Terris', 'Affiliation': 'Department of Urology, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Zumsteg', 'Affiliation': 'Department of Radiation Oncology, Cedars Sinai, West Hollywood, California.'}, {'ForeName': 'Santino', 'Initials': 'S', 'LastName': 'Butler', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Osborne', 'Affiliation': 'Department of Radiology, Weill Cornell, New York, New York.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Morgan', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Department of Pathology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Simpa S', 'Initials': 'SS', 'LastName': 'Salami', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Amar U', 'Initials': 'AU', 'LastName': 'Kishan', 'Affiliation': 'Department of Radiation Oncology, University of California, Los Angeles.'}, {'ForeName': 'Chenyang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, University of California, Los Angeles.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Schaeffer', 'Affiliation': 'Department of Urology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Mack', 'Initials': 'M', 'LastName': 'Roach', 'Affiliation': 'Department of Urology, University of California, San Francisco.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Pisansky', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'William U', 'Initials': 'WU', 'LastName': 'Shipley', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Freedland', 'Affiliation': 'Department of Urology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': 'Department of Radiation Oncology, Cedars Sinai, West Hollywood, California.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'Department of Urology, University of California, San Francisco.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Dignam', 'Affiliation': 'Department of Biostatistics, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Schipper', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}]",JAMA oncology,['10.1001/jamaoncol.2019.0826']
1061,30270543,Predictors of virological failure in HIV-1-infected patients switching to dolutegravir maintenance monotherapy.,"OBJECTIVES


The Dolutegravir Monotherapy for HIV (DOMONO; NCT02401828) study showed that maintenance monotherapy with dolutegravir (DTG) is associated with virological failure (VF) and leads to DTG resistance and as a result should not be used. However, data on clinical and virological factors associated with VF during DTG monotherapy are lacking. We identified factors associated with VF during DTG monotherapy.
METHODS


A randomized trial was carried out in which patients on combination antiretroviral therapy (cART) with an HIV-1 RNA zenith < 100 000 copies/mL and a CD4 T-cell nadir ≥ 200 cells/μL, who had never experienced VF, switched to DTG monotherapy. Clinical and virological factors were compared between patients with and without VF, using univariate analyses.
RESULTS


Eight of the 95 patients developed VF during DTG monotherapy. A total of 78 participants had reached week 48 when the study was discontinued. The median CD4 T-cell nadir was lower in patients with VF than in patients without VF [260 (interquartile range (IQR) 223-320) versus 380 (IQR 290-520) cells/μL, respectively; P = 0.011]. Patients with VF had a longer time between HIV diagnosis and cART initiation than those without VF [median 49 (IQR 27-64) versus 15 (IQR 1-38) months, respectively; P = 0.015]. The median total peripheral blood mononuclear cell (PBMC) HIV DNA copy number was higher in patients with VF than in those without VF [417 (range 85-4151) versus 147 (range 16-4132) copies/10 6  PBMCs, respectively; P = 0.022].
CONCLUSIONS


A lower CD4 nadir, a longer time between HIV diagnosis and cART initiation, and a higher HIV DNA copy number at the time of DTG monotherapy initiation were associated with VF. While there clearly is no future role for DTG monotherapy, ongoing and future studies on the efficacy of maintenance dual therapy (e.g. DTG lamivudine) may have to take these variables into account in their study design and analysis.",2019,"The median total peripheral blood mononuclear cell (PBMC) HIV DNA copy number was higher in patients with VF than in those without VF [417 (range 85-4151) versus 147 (range 16-4132) copies/10 6  PBMCs, respectively; P = 0.022].
","['A total of 78 participants had reached week 48 when the study was discontinued', 'patients on combination antiretroviral therapy (cART) with an HIV-1 RNA zenith', 'HIV-1-infected patients switching to dolutegravir maintenance monotherapy', '200 cells/μL, who had never experienced VF, switched to DTG monotherapy']","['DTG lamivudine', 'dolutegravir (DTG']","['median total peripheral blood mononuclear cell (PBMC) HIV DNA copy number', 'CD4 T-cell nadir', 'longer time between HIV diagnosis and cART initiation', 'median CD4 T-cell nadir', 'Clinical and virological factors', 'virological failure']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",78.0,0.0635769,"The median total peripheral blood mononuclear cell (PBMC) HIV DNA copy number was higher in patients with VF than in those without VF [417 (range 85-4151) versus 147 (range 16-4132) copies/10 6  PBMCs, respectively; P = 0.022].
","[{'ForeName': 'Iea', 'Initials': 'I', 'LastName': 'Wijting', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Rutsaert', 'Affiliation': 'Department of Internal Medicine, HIV Cure Research Center, Ghent University, Ghent, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rokx', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Burger', 'Affiliation': 'Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jja', 'Initials': 'J', 'LastName': 'van Kampen', 'Affiliation': 'Department of Viroscience, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Cab', 'Initials': 'C', 'LastName': 'Boucher', 'Affiliation': 'Department of Viroscience, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Bja', 'Initials': 'B', 'LastName': 'Rijnders', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vandekerckhove', 'Affiliation': 'Department of Internal Medicine, HIV Cure Research Center, Ghent University, Ghent, Belgium.'}]",HIV medicine,['10.1111/hiv.12675']
1062,32149929,Five-Year Follow-up of Minimally Invasive Distal Metatarsal Chevron Osteotomy in Comparison with the Open Technique: A Randomized Controlled Trial.,"BACKGROUND


The aim of the present prospective randomized study was to evaluate the long-term outcomes of minimally invasive chevron osteotomy as compared with open distal chevron osteotomy for the correction of hallux valgus deformity.
METHODS


A randomized controlled design was applied. The following parameters were assessed at 6 and 12 weeks, 9 months, and 5 years postoperatively: the American Orthopaedic Foot & Ankle Society (AOFAS) Forefoot Score, a visual analog scale (VAS) score for pain, and a patient-satisfaction score. In addition, several radiographic parameters for hallux valgus correction and joint degeneration were collected. Range of motion was also assessed. Thirty-nine of 47 feet were available for analysis at the time of the latest follow-up.
RESULTS


During the 5-year study period, the outcomes of the minimally invasive technique were comparable with those of the open technique. No significant differences were seen between the 2 groups within 5 years postoperatively in terms of clinical outcomes (VAS, AOFAS, satisfaction), radiographic outcomes, joint degeneration, or range of motion.
CONCLUSIONS


Five years after treatment, the outcome following minimally invasive distal chevron osteotomy is comparable with that for the open technique for hallux valgus surgery.
LEVELS OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"No significant differences were seen between the 2 groups within 5 years postoperatively in terms of clinical outcomes (VAS, AOFAS, satisfaction), radiographic outcomes, joint degeneration, or range of motion.
",[],"['open distal chevron osteotomy', 'minimally invasive distal chevron osteotomy', 'Minimally Invasive Distal Metatarsal Chevron Osteotomy', 'minimally invasive chevron osteotomy']","['American Orthopaedic Foot & Ankle Society (AOFAS', 'Forefoot Score, a visual analog scale (VAS) score for pain, and a patient-satisfaction score', 'clinical outcomes (VAS, AOFAS, satisfaction), radiographic outcomes, joint degeneration, or range of motion']",[],"[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C3163986', 'cui_str': 'Chevron osteotomy (procedure)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0025584', 'cui_str': 'Metatarsals'}]","[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0011164', 'cui_str': 'Degenerative abnormality'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}]",47.0,0.0814922,"No significant differences were seen between the 2 groups within 5 years postoperatively in terms of clinical outcomes (VAS, AOFAS, satisfaction), radiographic outcomes, joint degeneration, or range of motion.
","[{'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Kaufmann', 'Affiliation': 'OFZ-Orthopaedic and Foot Center Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Mörtlbauer', 'Affiliation': 'Orthopaedic Department (L.M., D.D., M.B., and M.L.) and the Department of Medical Statistics, Informatics and Health Economics (P.H.-P.), Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Hofer-Picout', 'Affiliation': 'Orthopaedic Department (L.M., D.D., M.B., and M.L.) and the Department of Medical Statistics, Informatics and Health Economics (P.H.-P.), Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Dammerer', 'Affiliation': 'Orthopaedic Department (L.M., D.D., M.B., and M.L.) and the Department of Medical Statistics, Informatics and Health Economics (P.H.-P.), Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ban', 'Affiliation': 'Orthopaedic Department (L.M., D.D., M.B., and M.L.) and the Department of Medical Statistics, Informatics and Health Economics (P.H.-P.), Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Liebensteiner', 'Affiliation': 'Orthopaedic Department (L.M., D.D., M.B., and M.L.) and the Department of Medical Statistics, Informatics and Health Economics (P.H.-P.), Medical University of Innsbruck, Innsbruck, Austria.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00981']
1063,30523055,Impact of induction regimen and allogeneic hematopoietic cell transplantation on outcome in younger adults with acute myeloid leukemia with a monosomal karyotype.,"Monosomal karyotype confers a poor prognosis in patients with acute myeloid leukemia. Here, we determined the impact of the type of remission-induction chemotherapy and the impact of having a donor in younger acute myeloid leukemia patients with a monosomal karyotype included in two phase III trials. In the first trial patients were randomized to receive either daunorubicin, mitoxantrone, or idarubicin in addition to standard-dose cytarabine and etoposide for induction chemotherapy. In the second trial patients were randomized to standard-dose cytarabine or high-dose cytarabine induction, both with daunorubicin and etoposide. In both trials, patients who achieved a complete remission with or without complete hematologic recovery underwent allogeneic hematopoietic stem cell transplantation if they had a donor; otherwise, they underwent autologous transplantation. In comparison to patients with intermediate-risk cytogenetics without a monosomal karyotype (n=1,584) and with adverse cytogenetics without a monosomal karyotype (n=218), patients with a monosomal karyotype (n=188) were more likely not to achieve a complete remission with or without count recovery [odds ratio=2.85, 95% confidence interval (95%, CI): 2.10-3.88] and had shorter overall survival [hazard ratio, (HR)=2.44, 95% CI: 2.08-2.88]. There was no impact of the type of anthracycline or of the dose of cytarabine on outcomes in patients with a monosomal karyotype. Among monosomal karyo type patients who achieved a complete remission with or without count recovery, HLA-identical related donor availability was associated with longer survival from complete remission with or without count recovery (HR=0.59, 95% CI: 0.37-0.95). ClinicalTrials.gov identifiers: AML-10: NCT00002549; AML-12: NCT00004128.",2019,There was no impact of the type of anthracycline or of the dose of cytarabine on outcomes in patients with a monosomal karyotype.,"['younger adults with acute myeloid leukemia with a monosomal karyotype', 'patients with acute myeloid leukemia', 'patients with a monosomal karyotype', 'younger acute myeloid leukemia patients with a monosomal karyotype included in two phase III trials']","['cytarabine', 'allogeneic hematopoietic cell transplantation', 'daunorubicin, mitoxantrone, or idarubicin in addition to standard-dose cytarabine and etoposide for induction chemotherapy', 'cytarabine or high-dose cytarabine induction, both with daunorubicin and etoposide', 'allogeneic hematopoietic stem cell transplantation', 'anthracycline']","['complete remission with or without count recovery', 'complete remission', 'overall survival']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C1261273', 'cui_str': 'Karyotype'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.218393,There was no impact of the type of anthracycline or of the dose of cytarabine on outcomes in patients with a monosomal karyotype.,"[{'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Baron', 'Affiliation': 'Groupe Interdisciplinaire de Génoprotéomique Appliquée (GIGA), Laboratory of Hematology, University of Liege, Belgium f.baron@ulg.ac.be.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Stevens-Kroef', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Meloni', 'Affiliation': 'Department of Hematology, Sapienza University, Rome, Italy.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Muus', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Marie', 'Affiliation': 'Department of Hematology, Saint Antoine Hospital, Paris, France.'}, {'ForeName': 'Constantijn J M', 'Initials': 'CJM', 'LastName': 'Halkes', 'Affiliation': 'Leiden University Medical Center, the Netherlands.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Thomas', 'Affiliation': 'CHU Lyon, France.'}, {'ForeName': 'Radovan', 'Initials': 'R', 'LastName': 'Vrhovac', 'Affiliation': 'University Hospital Center Zagreb, Croatia.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Albano', 'Affiliation': 'University of Bari, Italy.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lefrère', 'Affiliation': 'Necker Hospital, Paris, France.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Sica', 'Affiliation': 'Università Cattolica Sacro Cuore, Roma, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mancini', 'Affiliation': 'Department of Hematology, Sapienza University, Rome, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Venditti', 'Affiliation': 'University Tor Vergata, Roma, Italy.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hagemeijer', 'Affiliation': 'University of Leuven, Belgium.'}, {'ForeName': 'Joop H', 'Initials': 'JH', 'LastName': 'Jansen', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Amadori', 'Affiliation': 'University Tor Vergata, Roma, Italy.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'de Witte', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Roelof', 'Initials': 'R', 'LastName': 'Willemze', 'Affiliation': 'Leiden University Medical Center, the Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}]",Haematologica,['10.3324/haematol.2018.204826']
1064,31678769,Overestimated treatment effects in randomised phase II trials: What's up doctor?,,2019,,[],[],[],[],[],[],,0.0191432,,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Michiels', 'Affiliation': ""Service de Biostatistique et D'Épidémiologie, Gustave Roussy, Université Paris-Saclay, 94805 Villejuif, France; CESP INSERM U1018, Université Paris-Sud, Université Paris-Saclay, 94805 Villejuif, France. Electronic address: stefan.michiels@gustaveroussy.fr.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wason', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle Upon Tyne, UK; MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.09.023']
1065,31033232,Effect of Group-Based Outpatient Physical Therapy on Function After Total Knee Replacement: Results From a Multicenter Randomized Controlled Trial.,"OBJECTIVE


To evaluate the long-term clinical effectiveness of a novel group-based outpatient physical therapy (PT) following total knee replacement (TKR).
METHODS


In this 2-center, unblinded, superiority, randomized controlled trial, 180 patients on a waiting list for primary TKR due to osteoarthritis were randomized to a 6 session group-based outpatient PT intervention and usual care (n = 89) or usual care alone (n = 91). The primary outcome was patient-reported functional ability measured by the Lower Extremity Functional Scale at 12 months postoperative. Secondary outcomes included knee symptoms, depression, anxiety, and satisfaction. Questionnaires were completed preoperatively and at 3, 6, and 12 months postoperatively.
RESULTS


The mean difference in function between groups was 4.47 (95% confidence interval [95% CI] 0.20, 8.75; P = 0.04) at 12 months postoperative, favoring the intervention. The mean difference in function between groups decreased over time, from 8.1 points at 3 months (95% CI 3.8, 12.4; P < 0.001) to 5.4 (95% CI 1.1, 9.8; P = 0.015) at 6 months postoperative. There were no clinically relevant differences in any secondary outcomes between groups, although patients in the intervention group were more likely to be satisfied with their PT. No serious adverse events related to the intervention were reported.
CONCLUSION


Supplementing usual care with this group-based outpatient PT intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimum clinically important difference of 9 points. However, patient satisfaction was higher in the intervention group, and there was some evidence of clinically relevant improvements in function at 3 months.",2019,"Supplementing usual care with this group-based outpatient physiotherapy intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimal clinically important different of 9 points.","['function after total knee replacement', '180 patients on a waiting list for primary TKR due to osteoarthritis']","['6 session group-based outpatient physiotherapy intervention and usual care (n=89) or usual care alone', 'novel group-based outpatient physiotherapy following total knee replacement (TKR', 'group-based outpatient physiotherapy']","['knee symptoms, depression, anxiety and satisfaction', 'patient satisfaction', 'patient-reported functional ability measured by the Lower Extremity Functional Scale']","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale (assessment scale)'}]",180.0,0.145058,"Supplementing usual care with this group-based outpatient physiotherapy intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimal clinically important different of 9 points.","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lenguerrand', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Artz', 'Affiliation': 'University of West of England, Bristol, UK.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Marques', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sanderson', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': 'Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': 'University of Bristol and Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Tarique', 'Initials': 'T', 'LastName': 'Parwez', 'Affiliation': 'Luton and Dunstable Hospital, Luton and Dunstable University Hospital NHS Foundation Trust, Luton, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Bertram', 'Affiliation': 'University of Bristol and Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Beswick', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Burston', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gooberman-Hill', 'Affiliation': 'University of Bristol and NIHR Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Ashley W', 'Initials': 'AW', 'LastName': 'Blom', 'Affiliation': 'University of Bristol, Southmead Hospital, North Bristol NHS Trust, and NIHR Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Vikki', 'Initials': 'V', 'LastName': 'Wylde', 'Affiliation': 'University of Bristol and NIHR Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}]",Arthritis care & research,['10.1002/acr.23909']
1066,30420116,"A Phase III open-label, randomized, active controlled clinical study to assess safety, immunogenicity and lot-to-lot consistency of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants.","BACKGROUND


A heat-stable bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, ROTASIIL®) was developed in India. In this study, the vaccine was tested for safety, immunogenicity and clinical lot-to-lot consistency.
METHODS


This was a Phase III, open label, randomized, equivalence design study. The primary objective was to demonstrate lot-to-lot consistency of BRV-PV. Subjects were randomized into four arms, three arms received Lots A, B, and C of BRV-PV and the control arm, received Rotarix®. Three doses of BRV-PV or two doses of Rotarix® and one dose of placebo were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. The three lots of BRV-PV were equivalent if the 95% Confidence Intervals (CIs) of the geometric mean concentration (GMC) ratios were between 0.5 and 2. Solicited reactions were collected by using diary cards.
RESULTS


The study was conducted in 1500 randomized infants, of which 1341 infants completed the study. The IgA GMC ratios among the three lots were around 1 (Lot A versus Lot B: 1.07; Lot A versus Lot C: 1.06; and Lot B versus Lot C: 0.99). The 95% CIs for the GMC ratios were between 0.78 and 1.36. The IgA GMCs were: BRV-PV group 19.16 (95% CI 17.37-21.14) and Rotarix® group 10.92 (95% CI 9.36-12.74) (GMC ratio 1.75; 90% CI 1.51-2.04). Seropositivity rates were 46.98% (95% CI 43.86-50.11) and 31.12% (95% CI 26.17-36.41). The incidence of solicited reactions was comparable across the four arms. No serious adverse events were associated with the study vaccines, except two gastroenteritis events in the BRV-PV groups.
CONCLUSION


Lot-to-lot consistency of BRV-PV was demonstrated in terms of GMC ratios of IgA antibodies. The vaccine safety and immunogenicity profiles were similar to those of Rotarix®. Clinical Trials.Gov [NCT02584816] and Clinical Trial Registry of India [CTRI/2015/07/006034].",2018,"No serious adverse events were associated with the study vaccines, except two gastroenteritis events in the BRV-PV groups.
","['1500 randomized infants, of which 1341 infants completed the study', 'Indian infants']","['Rotarix®', 'BRV-PV and the control arm, received Rotarix®', 'bovine-human reassortant pentavalent rotavirus vaccine', 'placebo']","['incidence of solicited reactions', 'GMC ratios', 'serious adverse events', 'rotavirus IgA antibody levels', 'Seropositivity rates', 'geometric mean concentration (GMC) ratios', 'GMC ratios of IgA antibodies', 'vaccine safety and immunogenicity profiles', 'IgA GMC ratios', 'lot-to-lot consistency of BRV-PV']","[{'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}]","[{'cui': 'C1528012', 'cui_str': 'Rotarix'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2713569', 'cui_str': 'pentavalent rotavirus vaccine (RV5)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3476459', 'cui_str': 'Rotavirus IgA'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}]",1500.0,0.162642,"No serious adverse events were associated with the study vaccines, except two gastroenteritis events in the BRV-PV groups.
","[{'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Rathi', 'Affiliation': 'PATH, India.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Kawade', 'Affiliation': 'Vadu Rural Health Program KEM Hospital Research Centre, Vadu, Pune, India.'}, {'ForeName': 'Padmasani', 'Initials': 'P', 'LastName': 'Venkatramanan', 'Affiliation': 'Sri Ramachandra Medical Centre, Chennai, India.'}, {'ForeName': 'Ritabrata', 'Initials': 'R', 'LastName': 'Kundu', 'Affiliation': 'Institute of Child Health, Kolkata, India.'}, {'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Lalwani', 'Affiliation': 'Bharati Vidyapeeth Medical College & Hospital, Pune, India.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Dubey', 'Affiliation': 'Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Venkateswara Rao', 'Affiliation': 'Gandhi Medical College & Gandhi Hospital, Secunderabad, India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Narayanappa', 'Affiliation': 'JSS Medical College & Hospital, Mysore, India.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Ghildiyal', 'Affiliation': 'T.N. Medical College & B.Y.L. Nair Charitable Hospital, Mumbai, India.'}, {'ForeName': 'Nithya', 'Initials': 'N', 'LastName': 'Gogtay', 'Affiliation': 'Seth GS Medical College & KEM Hospital, Mumbai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Venugopal', 'Affiliation': 'Andhra Medical College, Visakhapatnam, India.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Palkar', 'Affiliation': 'Bharati Vidyapeeth Medical College & Hospital, Pune, India.'}, {'ForeName': 'Renuka', 'Initials': 'R', 'LastName': 'Munshi', 'Affiliation': 'T.N. Medical College & B.Y.L. Nair Charitable Hospital, Mumbai, India.'}, {'ForeName': 'Gagandeep', 'Initials': 'G', 'LastName': 'Kang', 'Affiliation': 'The Wellcome Trust Research Laboratory Christian Medical College, Vellore, India.'}, {'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Babji', 'Affiliation': 'The Wellcome Trust Research Laboratory Christian Medical College, Vellore, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bavdekar', 'Affiliation': 'Vadu Rural Health Program KEM Hospital Research Centre, Vadu, Pune, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Juvekar', 'Affiliation': 'Vadu Rural Health Program KEM Hospital Research Centre, Vadu, Pune, India.'}, {'ForeName': 'Nupur', 'Initials': 'N', 'LastName': 'Ganguly', 'Affiliation': 'Institute of Child Health, Kolkata, India.'}, {'ForeName': 'Prabal', 'Initials': 'P', 'LastName': 'Niyogi', 'Affiliation': 'Institute of Child Health, Kolkata, India.'}, {'ForeName': 'Kheya', 'Initials': 'K', 'LastName': 'Ghosh Uttam', 'Affiliation': 'Institute of Child Health, Kolkata, India.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Rajani', 'Affiliation': 'JSS Medical College & Hospital, Mysore, India.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Kondekar', 'Affiliation': 'T.N. Medical College & B.Y.L. Nair Charitable Hospital, Mumbai, India.'}, {'ForeName': 'Dipti', 'Initials': 'D', 'LastName': 'Kumbhar', 'Affiliation': 'T.N. Medical College & B.Y.L. Nair Charitable Hospital, Mumbai, India.'}, {'ForeName': 'Smilu', 'Initials': 'S', 'LastName': 'Mohanlal', 'Affiliation': 'T.N. Medical College & B.Y.L. Nair Charitable Hospital, Mumbai, India.'}, {'ForeName': 'Mukesh C', 'Initials': 'MC', 'LastName': 'Agarwal', 'Affiliation': 'Seth GS Medical College & KEM Hospital, Mumbai, India.'}, {'ForeName': 'Parvan', 'Initials': 'P', 'LastName': 'Shetty', 'Affiliation': 'Seth GS Medical College & KEM Hospital, Mumbai, India.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Antony', 'Affiliation': 'PATH, India.'}, {'ForeName': 'Bhagwat', 'Initials': 'B', 'LastName': 'Gunale', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Dharmadhikari', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Yuxiao', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'PATH, USA.'}, {'ForeName': 'Prasad S', 'Initials': 'PS', 'LastName': 'Kulkarni', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India. Electronic address: drpsk@seruminstitute.com.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH, USA.'}]",Vaccine,['10.1016/j.vaccine.2018.11.006']
1067,30526264,Overnight transdermal scopolamine patch administration has no clear effect on cognition and emotional processing in healthy volunteers.,"There has been increasing interest in the antidepressant effects of the muscarinic cholinergic receptor antagonist scopolamine. Here we assess, for the first time, whether a transdermal scopolamine patch is sufficient to induce changes in cognition that are consistent with the reported cognitive and antidepressant effects of scopolamine. A scopolamine or placebo patch was administered to healthy volunteers ( n=33) for 17 h in a double-blind, between-subject procedure. There was no clear effect of scopolamine patch on emotional cognition, verbal or working memory, suggesting that the effective dose of scopolamine available through the patch is too low to represent a viable antidepressant mechanism.",2019,"There was no clear effect of scopolamine patch on emotional cognition, verbal or working memory, suggesting that the effective dose of scopolamine available through the patch is too low to represent a viable antidepressant mechanism.","['healthy volunteers ( n=33) for 17 h in a double-blind, between-subject procedure', 'healthy volunteers']","['transdermal scopolamine patch', 'scopolamine or placebo patch', 'scopolamine patch', 'scopolamine']","['emotional cognition, verbal or working memory', 'cognition and emotional processing']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",,0.154299,"There was no clear effect of scopolamine patch on emotional cognition, verbal or working memory, suggesting that the effective dose of scopolamine available through the patch is too low to represent a viable antidepressant mechanism.","[{'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Bukala', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Browning', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Cowen', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susannah E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881118817161']
1068,31290104,Randomized Controlled Trial of One Anastomosis Gastric Bypass Versus Roux-En-Y Gastric Bypass for Obesity: Comparison of the YOMEGA and Taiwan Studies.,"BACKGROUND


The YOMEGA study (Y-study) was a randomized trial comparing one anastomosis gastric bypass (OAGB) and Roux-en-Y gastric bypass (RYGB). Here, we aim to compare the Y-study and our pioneer trial from Taiwan (T-study).
METHODS


Data from the Y-study and the T-study were collected and compared.
RESULTS


The Y-study recruited 234 patients with a mean body mass index (BMI) of 43.9 and age of 43.5 years. The T-study recruited 80 patients with a similar mean BMI of 44.3 and mean age of 31.4 years. The studies had similar findings including (1) OAGB is easier and possibly safer procedure than RYGB. Both studies showed that OAGB had a shorter operation time than RYGB, but a lower surgical complication rate was only demonstrated in T-study. (2) Both procedures have similar weight loss but OAGB features better glycemic control than RYGB. Weight loss at 2 years after surgery was similar between two procedures, but OAGB reduced HbA1c to a greater degree than RYGB at 2 years in Y-study (- 2.3% vs. - 1.3%; p = 0.025). The resolution of the metabolic syndrome was 100% for both groups in the T-study. (3) OAGB carried a higher risk of malnutrition. OAGB had more malabsorptive problems with a lower hemoglobin level than RYGB at 2 years after surgery. Adverse malnutrition events occurred in nine (7.8%) OAGB patients in the Y-study. Four (3.4%) patients of OAGB received revision surgery in Y-study but none in T-study. (4) Bile reflux was noted in OAGB patients but did not influence quality of life or revision rate. Y-study found that bile in the gastric pouch was present in 16% of patients in the OAGB group versus none in the RYGB, but no inter-group difference in quality of life was detected. There was a trend for RYGB patients to experience more abdominal pain than OAGB.
CONCLUSIONS


Both studies showed that OAGB is a technically easier procedure and features better glycemic control than RYGB, but has a mal-absorptive effect. However, the bile reflux and abdominal pain controversies persisted.",2019,"Weight loss at 2 years after surgery was similar between two procedures, but OAGB reduced HbA1c to a greater degree than RYGB at 2 years in Y-study (- 2.3% vs. - 1.3%; p = 0.025).","['80 patients with a similar mean BMI of 44.3 and mean age of 31.4\xa0years', 'Y-study and our pioneer trial from Taiwan (T-study', 'Data from the Y-study and the T-study were collected and compared', '234 patients with a mean body mass index (BMI) of 43.9 and age of 43.5\xa0years']","['OAGB', 'anastomosis gastric bypass (OAGB) and Roux-en-Y gastric bypass (RYGB', 'Anastomosis Gastric Bypass Versus Roux-En-Y Gastric Bypass']","['abdominal pain', 'Weight loss', 'resolution of the metabolic syndrome', 'Bile reflux', 'shorter operation time', 'quality of life or revision rate', 'surgical complication rate', 'malabsorptive problems', 'quality of life', 'Adverse malnutrition events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0005403', 'cui_str': 'Bile Reflux'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034380'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",234.0,0.0405206,"Weight loss at 2 years after surgery was similar between two procedures, but OAGB reduced HbA1c to a greater degree than RYGB at 2 years in Y-study (- 2.3% vs. - 1.3%; p = 0.025).","[{'ForeName': 'Wei-Jei', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Min-Sheng General Hospital, No. 168, Chin Kuo Road, Taoyuan, Taiwan, Republic of China. wjlee_obessurg_tw@yahoo.com.tw.'}, {'ForeName': 'Owaid M', 'Initials': 'OM', 'LastName': 'Almalki', 'Affiliation': 'Department of Surgery, College of Medicine, Taif University, Taif, Saudi Arabia.'}, {'ForeName': 'Kong-Han', 'Initials': 'KH', 'LastName': 'Ser', 'Affiliation': 'Department of Surgery, Min-Sheng General Hospital, No. 168, Chin Kuo Road, Taoyuan, Taiwan, Republic of China.'}, {'ForeName': 'Jung-Chien', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Surgery, Min-Sheng General Hospital, No. 168, Chin Kuo Road, Taoyuan, Taiwan, Republic of China.'}, {'ForeName': 'Yi-Chih', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of International Business, Chien Hsin University of Science and Technology, Taoyuan City, Taiwan.'}]",Obesity surgery,['10.1007/s11695-019-04065-2']
1069,31648764,Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve-Guided Revascularization Strategy.,"OBJECTIVES


This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)- and fractional flow reserve (FFR)-guided revascularization strategies.
BACKGROUND


An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes.
METHODS


This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization.
RESULTS


Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 ± 0.51 vs. 0.43 ± 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 ± 0.09 vs. 0.91 ± 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 ± 0.09 vs. 0.85 ± 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919).
CONCLUSIONS


An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (Functional Lesion Assessment of Intermediate Stenosis to guide Revascularization [DEFINE-FLAIR]; NCT02053038).",2019,"An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women.","['601 women and 1,891 men']",['iFR- or FFR-guided strategy'],"['mean iFR value', '1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization', 'MACE rates', 'instantaneous wave-free ratio (iFR)- and fractional flow reserve', 'rate of revascularization', 'mean FFR value', 'revascularization rate']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}]",601.0,0.110612,"An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women.","[{'ForeName': 'Chee Hae', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VHS Medical Center, Seoul, South Korea.'}, {'ForeName': 'Bon-Kwon', 'Initials': 'BK', 'LastName': 'Koo', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University, Seoul, South Korea; Institute on Aging, Seoul National University, Seoul, South Korea. Electronic address: bkkoo@snu.ac.kr.'}, {'ForeName': 'Hakim-Moulay', 'Initials': 'HM', 'LastName': 'Dehbi', 'Affiliation': 'Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Joo Myung', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joon-Hyung', 'Initials': 'JH', 'LastName': 'Doh', 'Affiliation': 'Department of Medicine, Inje University Ilsan Paik Hospital, Daehwa-dong, South Korea.'}, {'ForeName': 'Chang-Wook', 'Initials': 'CW', 'LastName': 'Nam', 'Affiliation': 'Department of Medicine, Keimyung University Dongsan Medical Center, Daegu, South Korea.'}, {'ForeName': 'Eun-Seok', 'Initials': 'ES', 'LastName': 'Shin', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Ulsan Medical Center, Ulsan Hospital, Ulsan, South Korea.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cook', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Al-Lamee', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Petraco', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Sayan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Iqbal S', 'Initials': 'IS', 'LastName': 'Malik', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Sukhjinder S', 'Initials': 'SS', 'LastName': 'Nijjer', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Hernán', 'Initials': 'H', 'LastName': 'Mejía-Rentería', 'Affiliation': 'Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Alegria-Barrero', 'Affiliation': 'Hospital Universitario de Torrejón, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alghamdi', 'Affiliation': 'King Abdulaziz Medical City Cardiac Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Altman', 'Affiliation': 'Colorado Heart and Vascular, Lakewood, Colorado.'}, {'ForeName': 'Sérgio B', 'Initials': 'SB', 'LastName': 'Baptista', 'Affiliation': 'Hospital Prof. Doutor Fernando Fonseca, Amadora, Portugal.'}, {'ForeName': 'Ravinay', 'Initials': 'R', 'LastName': 'Bhindi', 'Affiliation': 'Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Bojara', 'Affiliation': 'Gemeinschaftsklinikum Mittelrhein, Kemperhof Koblenz, Koblenz, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Cardiovascular Institute, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Pedro Canas', 'Initials': 'PC', 'LastName': 'Silva', 'Affiliation': 'Hospital Santa Maria, Lisbon, Portugal.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Mario', 'Affiliation': 'Royal Brompton Hospital, Imperial College London, London, United Kingdom; University of Florence, Florence, Italy.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'Pauls Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Gerber', 'Affiliation': 'Conquest Hospital, St Leonards-on-Sea, United Kingdom.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Going', 'Affiliation': 'Sana Klinikum Lichtenberg, Lichtenberg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Härle', 'Affiliation': 'Klinikum Oldenburg, European Medical School, Carl von Ossietzky University, Oldenburg, Germany.'}, {'ForeName': 'Farrel', 'Initials': 'F', 'LastName': 'Hellig', 'Affiliation': 'Sunninghill Hospital, Johannesburg, South Africa.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Indolfi', 'Affiliation': 'University Magna Graecia, Catanzaro, Italy.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Imelda Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Jeremias', 'Affiliation': 'Stony Brook University Medical Center, New York, New York.'}, {'ForeName': 'Rajesh K', 'Initials': 'RK', 'LastName': 'Kharbanda', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Khashaba', 'Affiliation': 'Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Yuetsu', 'Initials': 'Y', 'LastName': 'Kikuta', 'Affiliation': 'Fukuyama Cardiovascular Hospital, Fukuyama, Japan.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krackhardt', 'Affiliation': 'Charite Campus Virchow Klinikum, Universitaetsmedizin, Berlin, Germany.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Lehman', 'Affiliation': 'Flinders University, Adelaide, Australia.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Matsuo', 'Affiliation': 'Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Martijin', 'Initials': 'M', 'LastName': 'Meuwissen', 'Affiliation': 'Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Niccoli', 'Affiliation': 'Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'AMC Heart Center, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Flavo', 'Initials': 'F', 'LastName': 'Ribichini', 'Affiliation': 'University Hospital Verona, Verona, Italy.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Samady', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sapontis', 'Affiliation': 'MonashHeart, Monash University, Melbourne, Australia.'}, {'ForeName': 'Arnold H', 'Initials': 'AH', 'LastName': 'Seto', 'Affiliation': 'Veterans Affairs Long Beach Healthcare System, Long Beach, California.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Sezer', 'Affiliation': 'Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Andrew S P', 'Initials': 'ASP', 'LastName': 'Sharp', 'Affiliation': 'Royal Devon and Exeter Hospital, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Jasvindar', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Takashima', 'Affiliation': 'Aichi Medical University Hospital, Aichi, Japan.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Talwar', 'Affiliation': 'Royal Bournemouth General Hospital, Bournemouth, United Kingdom.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kare', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Essex Cardiothoracic Centre, Basildon, United Kingdom; Anglia Ruskin University, Chelmsford, United Kingdom.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Belle', 'Affiliation': 'Institut Coeur Poumon, Lille University Hospital, Lille, France; UMR INSERM 1011, Centre Hospitalier Universitaire de Lille et de Institut Pasteur de Lille, Université de Lille, Lille, France.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Vinhas', 'Affiliation': 'Hospital Garcia de Horta, Lisbon, Portugal.'}, {'ForeName': 'Christiaan J', 'Initials': 'CJ', 'LastName': 'Vrints', 'Affiliation': 'Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Walters', 'Affiliation': 'Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Yokoi', 'Affiliation': 'Fukuoka Sannou Hospital, Fukuoka, Japan.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Samuels', 'Affiliation': 'Cedars-Sinai Heart Institute, Los Angeles, California.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Buller', 'Affiliation': 'St. Michaels Hospital, Toronto, Canada.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Duke University, Durham, Norh Carolina.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.06.035']
1070,31199458,Differential Effects of Oral Boluses of Vitamin D2 vs Vitamin D3 on Vitamin D Metabolism: A Randomized Controlled Trial.,"CONTEXT


Vitamin D2 and vitamin D3 have been hypothesized to exert differential effects on vitamin D metabolism.
OBJECTIVE


To compare the influence of administering vitamin D2 vs vitamin D3 on metabolism of vitamin D3.
METHODS


We measured baseline and 4-month serum concentrations of vitamin D3, 25-hydroxyvitamin D3 [25(OH)D3], 25-hydroxyvitamin D2, 24R,25-dihydroxyvitamin D3 [24R,25(OH)2D3], 1α,25-dihydroxyvitamin D3 [1α,25(OH)2D3], and 4β,25-dihydroxyvitamin D3 [4β,25(OH)2D3] in 52 adults randomized to receive a total of four oral bolus doses of 2.5 mg vitamin D2 (n = 28) or vitamin D3 (n = 24) over four months. Metabolite-to-parent compound ratios were calculated to estimate hydroxylase activity. Pairwise before vs after comparisons were made to evaluate effects of vitamin D2 and vitamin D3 on metabolism of vitamin D. Mean postsupplementation metabolite-to-parent ratios were then compared between groups.
RESULTS


Vitamin D2 was less effective than vitamin D3 in elevating total serum 25(OH)D concentration. Vitamin D2 suppressed mean four-month serum concentrations of 25(OH)D3, 24R,25(OH)2D3, 1α,25(OH)2D3, and 4β,25(OH)2D3 and mean ratios of 25(OH)D3 to D3 and 1α,25(OH)2D3 to 25(OH)D3, while increasing the mean ratio of 24R,25(OH)2D3 to 25(OH)D3. Vitamin D3 increased mean four-month serum concentrations of 25(OH)D3, 24R,25(OH)2D3, 1α,25(OH)2D3, and 4β,25(OH)2D3 and the mean ratio of 24R,25(OH)2D3 to 25(OH)D3. Participants receiving vitamin D2 had lower mean postsupplementation ratios of 25(OH)D3 to vitamin D3 and 1α,25(OH)2D3 to 25(OH)D3 than those receiving vitamin D3. Mean postsupplementation ratios of 24R,25(OH)2D3 to 25(OH)D3 and 4β,25(OH)2D3 to 25(OH)D3 did not differ between groups.
CONCLUSIONS


Bolus-dose vitamin D2 is less effective than bolus-dose vitamin D3 in elevating total serum 25(OH)D concentration. Administration of vitamin D2 reduces 25-hydroxylation of vitamin D3 and 1-α hydroxylation of 25(OH)D3, while increasing 24R-hydroxylation of 25(OH)D3.",2019,"Participants receiving vitamin D2 had lower mean post-supplementation ratios of 25(OH)D3-to-vitamin D3 and 1α,25(OH)2D3-to-25(OH)D3 than those receiving vitamin D3.",['52 adults'],"['vitamin D2', 'vitamin D2 versus vitamin D3', 'vitamin D2 and vitamin D3', 'Vitamin D2 and vitamin D3', 'vitamin D2 (n=28) or vitamin D3', 'vitamin D2 vs vitamin D3', 'Vitamin D3', 'vitamin D3']","['vitamin D metabolism', 'total serum 25(OH)D concentration', 'vitamin D3 and 1-alpha hydroxylation of 25(OH)D3', 'mean ratio of 24R,25(OH)2D3-to-25(OH)D3', 'mean post-supplementation ratios of 25(OH)D3-to-vitamin D3 and 1α,25(OH)2D3-to-25(OH)D3', 'mean 4-month serum concentrations of 25(OH)D3, 24R,25(OH)2D3, 1α,25(OH)2D3 and 4β,25(OH)2D3, and the mean ratio of 24R,25(OH)2D3-to-25(OH)D3', 'Mean post-supplementation ratios of 24R,25(OH)2D3-to-25(OH)D3 and 4β,25(OH)2D3-to-25(OH)D3', 'serum concentrations of vitamin D3, 25-hydroxyvitamin D3 (25[OH]D3), 25-hydroxyvitamin D2, 24R,25-dihydroxyvitamin D3 (24R,25[OH]2D3), 1α,25-dihydroxyvitamin D3 (1α,25[OH]2D3) and 4β,25-dihydroxyvitamin D3 (4β,25[OH]2D3', 'Vitamin D2 suppressed mean 4-month serum concentrations of 25(OH)D3, 24R,25(OH)2D3, 1α,25(OH)2D3 and 4β,25(OH)2D3 and mean ratios of 25(OH)D3-to-D3 and 1α,25(OH)2D3-to-25(OH)D3', 'total 25(OH)D concentration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0020365', 'cui_str': 'Hydroxylation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0000343', 'cui_str': '25-Hydroxycalciferol'}, {'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}]",52.0,0.0303026,"Participants receiving vitamin D2 had lower mean post-supplementation ratios of 25(OH)D3-to-vitamin D3 and 1α,25(OH)2D3-to-25(OH)D3 than those receiving vitamin D3.","[{'ForeName': 'Adrian R', 'Initials': 'AR', 'LastName': 'Martineau', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Thummel', 'Affiliation': 'Department of Pharmaceutics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Zhican', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmaceutics, University of Washington, Seattle, Washington.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Jolliffe', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Boucher', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'Medical Research Council Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Nita G', 'Initials': 'NG', 'LastName': 'Forouhi', 'Affiliation': 'Medical Research Council Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'Hitman', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00207']
1071,31688579,"Effects of perimenopausal transdermal estradiol on self-reported sleep, independent of its effect on vasomotor symptom bother and depressive symptoms.","OBJECTIVE


The aim of this study was to determine the efficacy of transdermal estradiol (E2) plus intermittent progesterone (EPT) for improving self-reported sleep in perimenopausal women, after controlling for vasomotor symptoms (VMS) bother and depressive symptoms.
METHODS


Using a double-blind, placebo-controlled design, 172 healthy women meeting STRAW+10 criteria for being in the menopausal transition or early postmenopause were randomized to 12 months of transdermal E2 (0.1 mg/d) + 200 mg progesterone (12 d every 3 mo) or placebo. Using standard questionnaires, self-reported sleep, depression, and VMS bother were obtained at baseline and bimonthly postrandomization.
RESULTS


Controlling for baseline levels, EPT (vs placebo) led to reductions in minutes to fall asleep (estimate = -0.12, P = 0.002) and number of awakenings (estimate = -0.24, P = 0.04) over the 12 months. Controlling for changes in VMS bother and depressive symptoms, EPT still predicted reductions in minutes to fall asleep (estimate = -0.28, P = 0.02) and number of awakenings (estimate = -0.11, P = 0.02) over the 12 months.
CONCLUSIONS


We extend existing research by demonstrating that hormone therapy (HT) in subjective sleep cannot be fully explained by improvements in VMS bother or depressive symptoms. Research to examine the mechanism (s) underlying HT's effects on sleep would have public health significance for perimenopausal women and also advance our general understanding of the pathophysiology of impaired sleep.",2019,"RESULTS


Controlling for baseline levels, EPT (vs placebo) led to reductions in minutes to fall asleep (estimate =","['perimenopausal women', 'perimenopausal women, after controlling for vasomotor symptoms (VMS) bother and depressive symptoms', '172 healthy women meeting STRAW+10 criteria for being in the menopausal transition or early postmenopause']","['perimenopausal transdermal estradiol', 'placebo', 'transdermal estradiol (E2) plus intermittent progesterone (EPT', 'EPT (vs placebo', 'hormone therapy (HT', 'transdermal E2 (0.1\u200amg/d) + 200\u200amg progesterone']","['standard questionnaires, self-reported sleep, depression, and VMS bother', 'vasomotor symptom bother and depressive symptoms', 'VMS bother or depressive symptoms', 'number of awakenings']","[{'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0206159', 'cui_str': 'Post-menopausal Period'}]","[{'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}]",172.0,0.437726,"RESULTS


Controlling for baseline levels, EPT (vs placebo) led to reductions in minutes to fall asleep (estimate =","[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Geiger', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Tory', 'Initials': 'T', 'LastName': 'Eisenlohr-Moul', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Gordon', 'Affiliation': 'University of Regina, Regina, Saskatchewan, Canada.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Rubinow', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Girdler', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001398']
1072,30741854,Reimagining Health Communication: A Noninferiority Randomized Controlled Trial of Crowdsourced Intervention in China.,"BACKGROUND


Crowdsourcing, the process of shifting individual tasks to a large group, may be useful for health communication, making it more people-centered. We aimed to evaluate whether a crowdsourced video is noninferior to a social marketing video in promoting condom use.
METHODS


Men who have sex with men (≥16 years old, had condomless sex within 3 months) were recruited and randomly assigned to watch 1 of the 2 videos in 2015. The crowdsourced video was developed through an open contest, and the social marketing video was designed by using social marketing principles. Participants completed a baseline survey and follow-up surveys at 3 weeks and 3 months postintervention. The outcome was compared with a noninferiority margin of +10%.
RESULTS


Among the 1173 participants, 907 (77%) and 791 (67%) completed the 3-week and 3-month follow-ups. At 3 weeks, condomless sex was reported by 146 (33.6%) of 434 participants and 153 (32.3%) 473 participants in the crowdsourced and social marketing arms, respectively. The crowdsourced intervention achieved noninferiority (estimated difference, +1.3%; 95% confidence interval, -4.8% to 7.4%). At 3 months, 196 (52.1%) of 376 individuals and 206 (49.6%) of 415 individuals reported condomless sex in the crowdsourced and social-marketing arms (estimated difference: +2.5%, 95% confidence interval, -4.5 to 9.5%). The 2 arms also had similar human immunodeficiency virus testing rates and other condom-related secondary outcomes.
CONCLUSIONS


Our study demonstrates that crowdsourced message is noninferior to a social marketing intervention in promoting condom use among Chinese men who have sex with men. Crowdsourcing contests could have a wider reach than other approaches and create more people-centered intervention tools for human immunodeficiency virus control.",2019,"At 3 weeks, condomless sex was reported by 146 (33.6%) of 434 participants and 153 (32.3%) 473 participants in the crowdsourced and social marketing arms, respectively.","['Men who have sex with men (≥16 years old, had condomless sex within 3 months', 'Chinese men who have sex with men', 'China', '1173 participants, 907 (77%) and 791 (67%) completed the 3-week and 3-month follow-ups', 'Reimagining Health Communication']","['social marketing intervention', 'Crowdsourced Intervention']",['condomless sex'],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1512347', 'cui_str': 'Health Communication'}]","[{'cui': 'C0037424', 'cui_str': 'Social Marketing'}]","[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",434.0,0.13762,"At 3 weeks, condomless sex was reported by 146 (33.6%) of 434 participants and 153 (32.3%) 473 participants in the crowdsourced and social marketing arms, respectively.","[{'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'SESH Study Group of University of North Carolina at Chapel Hill, Guangzhou, China.'}, {'ForeName': 'Chuncheng', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'SESH Study Group of University of North Carolina at Chapel Hill, Guangzhou, China.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Mollan', 'Affiliation': 'School of Medicine.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Songyuan', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hudgens', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'School of Public Health, Shandong University.'}, {'ForeName': 'Dianmin', 'Initials': 'D', 'LastName': 'Kang', 'Affiliation': 'Shandong Provincial Center for Disease Prevention and Control, Jinan, China.'}, {'ForeName': 'Chongyi', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Sc Rutgers University, Newark, NJ.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000000930']
1073,31069575,Pirfenidone in Heart Failure with Preserved Ejection Fraction-Rationale and Design of the PIROUETTE Trial.,"BACKGROUND


The PIROUETTE (PIRfenidOne in patients with heart failUre and preserved lEfT venTricular Ejection fraction) trial is designed to evaluate the efficacy and safety of the anti-fibrotic pirfenidone in patients with chronic heart failure and preserved ejection fraction (HFpEF) and myocardial fibrosis. HFpEF is a diverse syndrome associated with substantial morbidity and mortality. Myocardial fibrosis is a key pathophysiological mechanism of HFpEF and myocardial fibrotic burden is strongly and independently associated with adverse outcome. Pirfenidone is an oral anti-fibrotic agent, without haemodynamic effect, that leads to regression of myocardial fibrosis in preclinical models. It has proven clinical effectiveness in pulmonary fibrosis.
METHODS


The PIROUETTE trial is a randomised, double-blind, placebo-controlled phase II trial evaluating the efficacy and safety of 52 weeks of treatment with pirfenidone in patients with chronic HFpEF (symptoms and signs of heart failure, left ventricular ejection fraction ≥ 45%, elevated natriuretic peptides [BNP ≥ 100 pg/ml or NT-proBNP ≥ 300 pg/ml; or BNP ≥ 300 pg/ml or NT-proBNP ≥ 900 pg/ml if in atrial fibrillation]) and myocardial fibrosis (extracellular matrix (ECM) volume ≥ 27% measured using cardiovascular magnetic resonance). The primary outcome measure is change in myocardial ECM volume. A sub-study will investigate the relationship between myocardial fibrosis and myocardial energetics, and the impact of pirfenidone, using  31 phosphorus magnetic resonance spectroscopy.
DISCUSSION


PIROUETTE will determine whether pirfenidone is superior to placebo in relation to regression of myocardial fibrosis and improvement in myocardial energetics in patients with HFpEF and myocardial fibrosis (NCT02932566).
CLINICAL TRIAL REGISTRATION


clinicaltrials.gov (NCT02932566) https://clinicaltrials.gov/ct2/show/NCT02932566.",2019,"Pirfenidone is an oral anti-fibrotic agent, without haemodynamic effect, that leads to regression of myocardial fibrosis in preclinical models.","['patients with heart failUre and preserved lEfT', 'patients with chronic heart failure and preserved ejection fraction (HFpEF) and myocardial fibrosis', 'patients with HFpEF and myocardial fibrosis (NCT02932566', 'patients with chronic HFpEF (symptoms and signs of heart failure, left ventricular ejection fraction ≥\u200945%, elevated natriuretic peptides [BNP\u2009≥\u2009100\xa0pg/ml or NT-proBNP ≥']","['anti-fibrotic pirfenidone', 'placebo', 'HFpEF', 'pirfenidone', 'Pirfenidone', 'NT-proBNP']","['change in myocardial ECM volume', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0151654', 'cui_str': 'Myocardial fibrosis'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}]","[{'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.223357,"Pirfenidone is an oral anti-fibrotic agent, without haemodynamic effect, that leads to regression of myocardial fibrosis in preclinical models.","[{'ForeName': 'Gavin A', 'Initials': 'GA', 'LastName': 'Lewis', 'Affiliation': 'Division of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Schelbert', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Josephine H', 'Initials': 'JH', 'LastName': 'Naish', 'Affiliation': 'Division of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Bedson', 'Affiliation': ""Clinical Trials Research Centre, 2nd Floor - Institute in the Park, Alder Hey Children's NHS Foundation Trust, University of Liverpool, Member of Liverpool Health Partners, Liverpool, L12 2AP, UK.""}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Member of Liverpool Health Partners, Block F, Waterhouse Bld, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Eccleson', 'Affiliation': ""Clinical Trials Research Centre, 2nd Floor - Institute in the Park, Alder Hey Children's NHS Foundation Trust, University of Liverpool, Member of Liverpool Health Partners, Liverpool, L12 2AP, UK.""}, {'ForeName': 'Dannii', 'Initials': 'D', 'LastName': 'Clayton', 'Affiliation': ""Clinical Trials Research Centre, 2nd Floor - Institute in the Park, Alder Hey Children's NHS Foundation Trust, University of Liverpool, Member of Liverpool Health Partners, Liverpool, L12 2AP, UK.""}, {'ForeName': 'Beatriz Duran', 'Initials': 'BD', 'LastName': 'Jimenez', 'Affiliation': 'Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'McDonagh', 'Affiliation': ""King's College Hospital, Denmark Hill, London, SE5 9RS, UK.""}, {'ForeName': 'Simon G', 'Initials': 'SG', 'LastName': 'Williams', 'Affiliation': 'Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cooper', 'Affiliation': 'Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Cunnington', 'Affiliation': 'Division of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Fozia Zahir', 'Initials': 'FZ', 'LastName': 'Ahmed', 'Affiliation': 'Division of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Rajavarma', 'Initials': 'R', 'LastName': 'Viswesvaraiah', 'Affiliation': 'Stockport NHS Foundation Trust, Stepping Hill Hospital, Poplar Grove, Hazel Grove, Stockport, SK2 7JE, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Russell', 'Affiliation': 'East Cheshire NHS Trust, Victoria Road, Macclesfield, SK10 3BL, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Neubauer', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Member of Liverpool Health Partners, Block F, Waterhouse Bld, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Miller', 'Affiliation': 'Division of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PL, UK. Christopher.Miller@manchester.ac.uk.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-019-06876-y']
1074,32092098,Effects of immersive virtual reality therapy on intravenous patient-controlled sedation during orthopaedic surgery under regional anesthesia: A randomized controlled trial.,"BACKGROUND


Immersive virtual reality (IVR) is a form of distraction therapy that has shown potential as an analgesia and sedation sparing agent. This study assessed the effect of IVR on the self-administered sedation requirements of patients undergoing joint replacement surgery under regional anesthesia in a single center.
METHODS AND FINDINGS


This study was a single-center, randomized control trial at St Vincent's Hospital in Melbourne, Australia. Fifty patients undergoing elective total knee and total hip arthroplasty were randomized to IVR and Propofol patient-controlled sedation (PCS) or propofol PCS alone. The primary outcome measure was intra-operative propofol use. Secondary outcomes included pattern of propofol use over time, use of adjunct analgesia, unmet propofol demand, and patient satisfaction survey scores. Of 50 total patients, 25 received IVR in conjunction with PCS, and 25 received PCS alone. All patients received adjunct analgesia from the treating Anesthesiologist. Median propofol use/hour over the entire procedure in the control group was 40 (11.1, 93.9) mg/hour compared with 45 (0, 94.7) mg/hour in the IVR group (p = 0.90). There were no differences in patterns of propofol use over the course of each procedure. Adjusting for various baseline characteristics did not change the results. Postoperative satisfaction scores were equivalent in both groups. The VR intervention was well tolerated by all patients, with no report of major side effects. Key limitations were relatively small sample size, the non-blinded nature of the study, and use of adjunct analgesia.
CONCLUSIONS


In patients receiving joint replacement surgery under regional anesthesia with PCS, IVR was well tolerated but did not decrease the overall sedation requirement.",2020,Postoperative satisfaction scores were equivalent in both groups.,"['patients receiving joint replacement surgery under regional anesthesia with PCS, IVR', 'Fifty patients undergoing elective total knee and total hip arthroplasty', ""St Vincent's Hospital in Melbourne, Australia"", 'patients undergoing joint replacement surgery under regional anesthesia in a single center', 'intravenous patient-controlled sedation during orthopaedic surgery under regional anesthesia', '50 total patients, 25 received IVR in conjunction with PCS, and 25 received']","['VR intervention', 'Immersive virtual reality (IVR', 'IVR and Propofol patient-controlled sedation (PCS) or propofol PCS alone', 'PCS alone', 'IVR', 'immersive virtual reality therapy']","['Median propofol use/hour over the entire procedure', 'pattern of propofol use over time, use of adjunct analgesia, unmet propofol demand, and patient satisfaction survey scores', 'intra-operative propofol use', 'overall sedation requirement', 'Postoperative satisfaction scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0185317', 'cui_str': 'Joint Replacement'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C3494470', 'cui_str': 'Virtual Reality Immersion Therapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",50.0,0.0783948,Postoperative satisfaction scores were equivalent in both groups.,"[{'ForeName': 'Mark Y', 'Initials': 'MY', 'LastName': 'Huang', 'Affiliation': ""Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Scharf', 'Affiliation': ""Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia.""}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Chan', 'Affiliation': ""Department of Critical Care Medicine, St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia.""}]",PloS one,['10.1371/journal.pone.0229320']
1075,31119692,Absolute Bioavailability of Esaxerenone and Food Effects on its Pharmacokinetics After a Single Oral Dose in Healthy Japanese Subjects: An Open-Label Crossover Study.,"INTRODUCTION


To investigate the absolute bioavailability of esaxerenone and the effects of food on its pharmacokinetics (PK) after a single oral dose in healthy Japanese subjects.
METHODS


Twenty-four Japanese males aged 20-45 years were randomised to six groups (each n = 4) in this single-centre, open-label, three-way, three-period crossover study. Esaxerenone (5 mg) was administered in the fasting state as a single oral dose, single intravenous infusion over 1 h, or in the postprandial state as a single oral dose. Plasma samples were taken before and during the 96 h after drug administration. Drug concentrations were measured using liquid chromatography-tandem mass spectrometry. PK parameters were calculated using noncompartmental analysis, and safety was assessed.
RESULTS


After fasting intravenous administration, total body clearance was 3.69 L h -1  and volume of distribution was 92.7 L. The plasma concentration-time profile of esaxerenone was similar after fasting and postprandial administration. Absolute bioavailability of a single oral 5-mg dose of esaxerenone was 89.0% in the fasting state and 90.8% postprandially. Point estimates (1.010 and 1.019, respectively) and 90% confidence intervals for geometric least squares mean peak plasma concentrations and area under the plasma concentration-time curve ratios after postprandial versus fasting oral esaxerenone were within the prespecified range (0.80, 1.25). No severe adverse events occurred throughout the study.
CONCLUSIONS


Esaxerenone has a high absolute bioavailability of approximately 90% and food has no effect on esaxerenone PK after a single oral dose of 5 mg in healthy Japanese subjects. Additionally, no safety concerns were identified.
CLINICAL TRIAL REGISTRATION


JapicCTI No. 163452.
FUNDING


Daiichi Sankyo Co., Ltd.",2019,"No severe adverse events occurred throughout the study.
","['Twenty-four Japanese males aged 20-45\xa0years', 'Healthy Japanese Subjects', 'healthy Japanese subjects']","['esaxerenone', 'Esaxerenone']","['geometric least squares mean peak plasma concentrations and area under the plasma concentration-time curve ratios after postprandial versus fasting oral esaxerenone', 'plasma concentration-time profile of esaxerenone', 'total body clearance', 'severe adverse events', 'PK parameters', 'Absolute bioavailability', 'Drug concentrations']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",24.0,0.0290026,"No severe adverse events occurred throughout the study.
","[{'ForeName': 'Akifumi', 'Initials': 'A', 'LastName': 'Kurata', 'Affiliation': 'Clinical Pharmacology Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan. kurata.akifumi.vz@daiichisankyo.co.jp.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Furuie', 'Affiliation': 'Medical Office, Osaka Pharmacology Clinical Research Hospital, Osaka, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Ishizuka', 'Affiliation': 'Clinical Pharmacology Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Nakatsu', 'Affiliation': 'Biostatistics and Data Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Clinical Pharmacology Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Clinical Pharmacology Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Nishikawa', 'Affiliation': 'Safety and Risk Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ishizuka', 'Affiliation': 'Clinical Pharmacology Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}]",Advances in therapy,['10.1007/s12325-019-00956-z']
1076,31119695,Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion.,"INTRODUCTION


This exploratory study characterized the performance of a nasal dilator strip with improved spring forces in lowering nasal resistance during sleep and reducing sleep-disordered breathing in subjects with difficulty sleeping due to chronic nocturnal nasal congestion.
METHODS


Subjects applied the strip at bedtime for 28 days (active phase; n = 70). Objective assessments included snoring variables, breathing route during sleep, and polysomnography measures compared with baseline. Nasal breathing, congestion, and sleep were measured subjectively using rating scales and questionnaires. During a crossover nasal resistance phase (n = 55), nasal resistance was measured using posterior rhinomanometry with the strip applied on one of two nights.
RESULTS


In the active phase, breathing and sleep were perceived to improve, with less daytime sleepiness (P < 0.04) and increased ease of breathing, sleep quality, staying asleep, and feeling refreshed in the morning (all P < 0.0001). However, while objective polysomnography metrics were generally similar with and without the strip, median wake after sleep onset time was numerically reduced by ~ 11 min, and the spontaneous arousal rate fell by ~ 37%. In the nasal resistance phase (n = 55), median resistance (at 0.2-0.25 l/s) while asleep was 39.1% lower with (n = 37) versus without (n = 36) the strip (1.34 vs. 2.20 cmH 2 O/l/s; P = 0.048).
CONCLUSIONS


This exploratory study supports a role for the improved spring force nasal dilator strip in alleviating sleep-related symptoms in subjects with chronic nasal congestion, potentially via lowering nasal resistance and reducing nocturnal awakenings. A larger study is indicated to confirm these preliminary data. CLINICALTRIALS.
GOV IDENTIFIER


NCT03105297.
FUNDING


GlaxoSmithKline Consumer Healthcare. Plain language summary available for this article.",2019,"In the active phase, breathing and sleep were perceived to improve, with less daytime sleepiness (P < 0.04) and increased ease of breathing, sleep quality, staying asleep, and feeling refreshed in the morning (all P < 0.0001).","['Subjects applied the strip at bedtime for 28\xa0days (active phase; n\u2009=\u200970', 'subjects with difficulty sleeping due to chronic nocturnal nasal congestion', 'subjects with chronic nasal congestion, potentially via lowering nasal resistance and reducing nocturnal awakenings', 'Subjects with Chronic Nocturnal Nasal Congestion']","['Prototype Nasal Dilator Strip', 'nasal dilator strip with improved spring forces']","['spontaneous arousal rate fell', 'snoring variables, breathing route during sleep, and polysomnography measures', 'ease of breathing, sleep quality, staying asleep, and feeling refreshed in the morning', 'Nasal breathing, congestion, and sleep', 'median wake after sleep onset time', 'daytime sleepiness', 'nasal resistance', 'objective polysomnography metrics', 'median resistance']","[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0746757', 'cui_str': 'Chronic nasal congestion'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0860510', 'cui_str': 'Nocturnal awakening'}]","[{'cui': 'C0180437', 'cui_str': 'Nasal dilator'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0700148', 'cui_str': 'Congestion (morphologic abnormality)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance (observable entity)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",,0.0578437,"In the active phase, breathing and sleep were perceived to improve, with less daytime sleepiness (P < 0.04) and increased ease of breathing, sleep quality, staying asleep, and feeling refreshed in the morning (all P < 0.0001).","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Wheatley', 'Affiliation': 'University of Sydney at Westmead Hospital, Westmead, NSW, Australia. john.wheatley@sydney.edu.au.'}, {'ForeName': 'Terence C', 'Initials': 'TC', 'LastName': 'Amis', 'Affiliation': 'University of Sydney at Westmead Hospital, Westmead, NSW, Australia.'}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'University of Sydney at Westmead Hospital, Westmead, NSW, Australia.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Ciesla', 'Affiliation': 'GlaxoSmithKline Consumer Healthcare, Warren, NJ, USA.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Shanga', 'Affiliation': 'GlaxoSmithKline Consumer Healthcare, Warren, NJ, USA.'}]",Advances in therapy,['10.1007/s12325-019-00980-z']
1077,31120501,Effect of Gemcitabine and nab-Paclitaxel With or Without Hydroxychloroquine on Patients With Advanced Pancreatic Cancer: A Phase 2 Randomized Clinical Trial.,"Importance


Autophagy is a mechanism of treatment resistance to chemotherapy that has a role in the maintenance of pancreatic cancer. Hydroxychloroquine sulfate (HCQ) is an inhibitor of autophagy that inhibits the fusion of the autophagosome to the lysosome.
Objective


To determine whether HCQ improves overall survival at 1 year in combination with gemcitabine hydrochloride and nab-paclitaxel (GA) among patients with metastatic pancreatic cancer.
Design, Setting, and Participants


Open-label, phase 2 randomized clinical trial conducted between March 18, 2013, and November 16, 2017, at the University of Pennsylvania, HonorHealth, and The Johns Hopkins University among 112 patients with previously untreated metastatic or advanced pancreatic ductal adenocarcinoma, Eastern Cooperative Oncology Group performance status of 0 or 1, and adequate marrow and organ function. All efficacy analyses were performed for the intention-to-treat population.
Interventions


Patients were randomized in a 1:1 ratio to receive GA with or without HCQ. All patients received standard doses of GA, and those randomized to receive HCQ were treated continuously with 600 mg orally twice daily.
Main Outcome and Measure


Overall survival at 1 year.
Results


A total of 112 patients (45 women and 67 men; median age, 65 years; range, 43-86 years) were enrolled; 55 were randomized to receive GA plus HCQ, and 57 to receive GA. Overall survival at 12 months was 41% (95% CI, 27%-53%) in the HCQ group and 49% (95% CI, 35%-61%) in the non-HCQ group. Median progression-free survival was 5.7 months (95% CI, 4.0-9.3 months) in the HCQ group and 6.4 months (95% CI, 4.5-7.6 months) in the non-HCQ group. Median overall survival was 11.1 months (95% CI, 9.0-14.2 months) in the HCQ group and 12.1 months (95% CI, 9.3-15.5 months) in the non-HCQ group. Overall response rate was 38.2% (n = 21) in the HCQ group and 21.1% (n = 12) in the non-HCQ group (P = .047). Treatment-related grade 3 or 4 adverse events that differed between the HCQ and non-HCQ groups were neutropenia (23 of 54 [42.6%] vs 12 of 53 [22.6%]), anemia (2 of 54 [3.7%] vs 9 of 53 [17.0%]), fatigue (4 of 54 [7.4%] vs 0), nausea (5 of 54 [9.3%] vs 0), peripheral neuropathy (7 of 54 [13.0%] vs 3 of 53 [5.7%]), visual changes (3 of 54 [5.6%] vs 0), and neuropsychiatric symptoms (3 of 54 [5.6%] vs 0).
Conclusions and Relevance


The addition of HCQ to block autophagy did not improve the primary end point of overall survival at 12 months. These data do not support the routine use of GA plus HCQ for metastatic pancreatic cancer in the absence of a biomarker. However, improvement seen in the overall response rate with HCQ may indicate a role for HCQ in the locally advanced setting, where tumor response may permit resection.
Trial Registration


ClinicalTrials.gov identifier: NCT01506973.",2019,"Overall survival at 12 months was 41% (95% CI, 27%-53%) in the HCQ group and 49% (95% CI, 35%-61%) in the non-HCQ group.","['patients with metastatic pancreatic cancer', 'Patients With Advanced Pancreatic Cancer', 'Participants\n\n\nOpen-label, phase 2 randomized clinical trial conducted between March 18, 2013, and November 16, 2017, at the University of Pennsylvania, HonorHealth, and The Johns Hopkins University among 112 patients with previously untreated metastatic or advanced pancreatic ductal adenocarcinoma, Eastern Cooperative Oncology Group performance status of 0 or 1, and adequate marrow and organ function', '112 patients (45 women and 67 men; median age, 65 years; range, 43-86 years) were enrolled; 55']","['Hydroxychloroquine sulfate (HCQ', 'Gemcitabine and nab-Paclitaxel With or Without Hydroxychloroquine', 'GA plus HCQ, and 57 to receive GA', 'GA with or without HCQ', 'HCQ', 'GA plus HCQ', 'gemcitabine hydrochloride and nab-paclitaxel (GA']","['fatigue', 'Main Outcome and Measure\n\n\nOverall survival', 'nausea', 'neuropsychiatric symptoms', 'Overall survival', 'Overall response rate', 'peripheral neuropathy', 'neutropenia', 'visual changes', 'anemia', 'Median progression-free survival', 'Median overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0596007', 'cui_str': 'Hydroxychloroquine Sulfate'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0771488', 'cui_str': 'Gemcitabine hydrochloride'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C4285807', 'cui_str': 'Neuropsychiatric symptoms'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",112.0,0.195665,"Overall survival at 12 months was 41% (95% CI, 27%-53%) in the HCQ group and 49% (95% CI, 35%-61%) in the non-HCQ group.","[{'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Karasic', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': ""O'Hara"", 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Loaiza-Bonilla', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Reiss', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ursina R', 'Initials': 'UR', 'LastName': 'Teitelbaum', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Erkut', 'Initials': 'E', 'LastName': 'Borazanci', 'Affiliation': 'Virginia G. Piper Cancer Center, HonorHealth, Phoenix, Arizona.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'De Jesus-Acosta', 'Affiliation': 'Sidney Kimmel Cancer Center, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Redlinger', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Burrell', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Laheru', 'Affiliation': 'Sidney Kimmel Cancer Center, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Von Hoff', 'Affiliation': 'Virginia G. Piper Cancer Center, HonorHealth, Phoenix, Arizona.'}, {'ForeName': 'Ravi K', 'Initials': 'RK', 'LastName': 'Amaravadi', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Drebin', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia.'}]",JAMA oncology,['10.1001/jamaoncol.2019.0684']
1078,30470690,Initial Report of Second-Line FOLFIRI in Combination with Ramucirumab in Advanced Gastroesophageal Adenocarcinomas: A Multi-Institutional Retrospective Analysis.,"BACKGROUND


The randomized phase III RAINBOW trial established paclitaxel (pac) plus ramucirumab (ram) as a global standard for second-line (2L) therapy in advanced gastric and gastroesophageal junction adenocarcinoma, together gastroesophageal adenocarcinoma (GEA). Patients (pts) receiving first-line (1L) FOLFOX often develop neuropathy that renders continued neurotoxic agents in the 2L setting unappealing and other regimens more desirable. As such, FOLFIRI-ram has become an option for patients with 2L GEA. FOLFIRI-ramucirumab (ram) has demonstrated safety and activity in 2L colorectal cancer, but efficacy/safety data in GEA are lacking.
SUBJECTS, MATERIALS, AND METHODS


Patients with GEA treated with 2L FOLFIRI-ram between August 2014 and April 2018 were identified. Clinicopathologic data including oxaliplatin neurotoxicity rates/grades (G), 2L treatment response, progression-free survival (PFS), overall survival (OS), safety, and molecular features were abstracted from three U.S. academic institutions. Kaplan-Meier survival analysis was used to generate PFS/OS; the likelihood ratio test was used to determine statistical significance.
RESULTS


We identified 29 pts who received 2L FOLFIRI-ram. All pts received 1L platinum + fluoropyrimidine, and 23 of 29 (79%) had post-1L neuropathy; 12 (41%) had G1, and 11 (38%) had G2. Patients were evenly split between esophagus/gastroesophageal junction (12; 41%) and gastric cancer (17; 59%). Among evaluable pts (26/29), the overall response rate was 23% (all partial response) with a disease control rate of 79%. Median PFS was 6.0 months and median OS was 13.4 months among all evaluable pts. Six- and 12-month OS were 90% ( n  = 18/20) and 41% ( n  = 7/17). There were no new safety signals.
CONCLUSION


We provide the first data suggesting FOLFIRI-ram is a safe, non-neurotoxic regimen comparing favorably with the combination of pac + ram used in the seminal RAINBOW trial.
IMPLICATIONS FOR PRACTICE


Results of this study provide initial support for the safety and efficacy of second-line (2L) FOLFIRI-ramucirumab (ram) after progression on first-line platinum/fluoropyrimidine in patients with gastroesophageal adenocarcinoma (GEA). The overall response, progression-free survival, overall survival, and toxicity profile compare favorably with paclitaxel (pac) + ram and highlight the importance of the ongoing phase II RAMIRIS trial examining FOLFIRI-ram versus pac + ram in 2L GEA (NCT03081143). FOLFIRI-ram may warrant consideration for inclusion as an alternate regimen in consensus guidelines for GEA.",2019,"The overall response, progression-free survival, overall survival, and toxicity profile compare favorably with paclitaxel (pac) + ram and highlight the importance of the ongoing phase II RAMIRIS trial examining FOLFIRI-ram versus pac + ram in 2L GEA (NCT03081143).","['Patients (pts', 'Patients were evenly split between esophagus/gastroesophageal junction (12; 41%) and gastric cancer (17; 59', 'Advanced Gastroesophageal Adenocarcinomas', '29 pts who received 2L FOLFIRI-ram', 'patients with 2L GEA', 'advanced gastric and gastroesophageal junction adenocarcinoma, together gastroesophageal adenocarcinoma (GEA', 'Patients with GEA treated with 2L FOLFIRI-ram between August 2014 and April 2018 were identified', 'patients with gastroesophageal adenocarcinoma (GEA']","['second-line (2L) FOLFIRI-ramucirumab (ram', 'paclitaxel (pac) plus ramucirumab (ram', 'FOLFIRI-ramucirumab (ram', 'Ramucirumab', '1L platinum + fluoropyrimidine', 'fluoropyrimidine', 'receiving first-line (1L) FOLFOX']","['oxaliplatin neurotoxicity rates/grades (G), 2L treatment response, progression-free survival (PFS), overall survival (OS), safety, and molecular features', 'overall response, progression-free survival, overall survival, and toxicity profile', 'overall response rate', 'post-1L neuropathy', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014876', 'cui_str': 'Esophagus'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.040663,"The overall response, progression-free survival, overall survival, and toxicity profile compare favorably with paclitaxel (pac) + ram and highlight the importance of the ongoing phase II RAMIRIS trial examining FOLFIRI-ram versus pac + ram in 2L GEA (NCT03081143).","[{'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Klempner', 'Affiliation': 'The Angeles Clinic and Research Institute, Los Angeles, California, USA.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Maron', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, University of Chicago Medical Center and Biological Sciences, Chicago, Illinois, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Chase', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, University of Chicago Medical Center and Biological Sciences, Chicago, Illinois, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Lomnicki', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, University of Chicago Medical Center and Biological Sciences, Chicago, Illinois, USA.'}, {'ForeName': 'Zev A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Daniel V T', 'Initials': 'DVT', 'LastName': 'Catenacci', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, University of Chicago Medical Center and Biological Sciences, Chicago, Illinois, USA dcatenac@bsd.uchicago.edu.'}]",The oncologist,['10.1634/theoncologist.2018-0602']
1079,31125395,Cabotegravir Is Not Associated With Weight Gain in Human Immunodeficiency Virus-uninfected Individuals in HPTN 077.,Studies in human immunodeficiency virus (HIV)-infected individuals suggest excess weight gain with integrase inhibitor-based antiretroviral therapy. The HIV Prevention Trials Network Study 077 evaluated changes in weight and fasting metabolic parameters in HIV-uninfected individuals randomized to cabotegravir or a placebo. No differences between arms were found for change in weight or fasting metabolic parameters overall or for subgroups.,2020,No differences between arms were found for change in weight or fasting metabolic parameters overall or for subgroups.,['HIV-uninfected Individuals in HPTN 077'],['placebo'],"['weight and fasting metabolic parameters', 'weight gain', 'weight or fasting metabolic parameters', 'Weight Gain']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",,0.0633201,No differences between arms were found for change in weight or fasting metabolic parameters overall or for subgroups.,"[{'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Landovitz', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Center for AIDS Research and Education & Center for HIV Prevention, David Geffen School of Medicine at University of California, Los Angeles.'}, {'ForeName': 'Sahar Z', 'Initials': 'SZ', 'LastName': 'Zangeneh', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Chau', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'Laboratório de HIV, Instituto Nacional de Infectologia Evandro Chagas (INI), Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Eron', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Halima', 'Initials': 'H', 'LastName': 'Dawood', 'Affiliation': 'Department of Medicine, University of KwaZulu-Natal, Pietermaritzburg, Durban, South Africa.'}, {'ForeName': 'Manya', 'Initials': 'M', 'LastName': 'Magnus', 'Affiliation': 'Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, George Washington University, Washington, DC.'}, {'ForeName': 'Albert Y', 'Initials': 'AY', 'LastName': 'Liu', 'Affiliation': 'Bridge HIV, Population Health Division, San Francisco Department of Public Health, California.'}, {'ForeName': 'Ravindre', 'Initials': 'R', 'LastName': 'Panchia', 'Affiliation': 'Perinatal HIV Research Unit, Chris Hani Baragwanath Academic Hospital, University of the Witwatersrand, Soweto, South Africa.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina at Chapel Hill School of Medicine.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Kofron', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Center for AIDS Research and Education & Center for HIV Prevention, David Geffen School of Medicine at University of California, Los Angeles.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Margolis', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, Durham, North Carolina.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rinehart', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, Durham, North Carolina.'}, {'ForeName': 'Adeola', 'Initials': 'A', 'LastName': 'Adeyeye', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Disease, National Institutes of Health, Rockville, Maryland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burns', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Disease, National Institutes of Health, Rockville, Maryland.'}, {'ForeName': 'Marybeth', 'Initials': 'M', 'LastName': 'McCauley', 'Affiliation': 'Science Facilitation Department, FHI 360, Washington DC.'}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Center for AIDS Research and Education & Center for HIV Prevention, David Geffen School of Medicine at University of California, Los Angeles.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz439']
1080,31109190,Integrating Data From Randomized Controlled Trials and Observational Studies to Assess Survival in Rare Diseases.,"Background Conducting randomized controlled trials to investigate survival in a rare disease like pulmonary arterial hypertension has considerable ethical and logistical constraints. In many studies, such as the Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome (SERAPHIN) randomized controlled trial, evaluating survival is further complicated by bias introduced by allowing active therapy among placebo-treated patients who clinically deteriorate. Methods and Results SERAPHIN enrolled and followed patients in the same time frame as the US Registry to Evaluate Early And Long-term PAH Disease Management, providing an opportunity to compare observed survival for SERAPHIN patients with predicted survival had they received real-world treatment as in the Registry to Evaluate Early And Long-term PAH Disease Management. From the Registry to Evaluate Early And Long-term PAH Disease Management (N=3515), 734 patients who met SERAPHIN eligibility criteria were selected and their data used to build a prediction model for time to death up to 3 years based on 10 baseline prognostic variables. The model was used to predict a survival curve for each of the 742 SERAPHIN patients via their baseline variables. The average of these predicted survival curves was compared with observed survival of the placebo (n=250) and macitentan 10 mg (n=242) groups using a log-rank test and Cox proportional hazard model. Observed mortality risk for patients randomized to placebo, 62% of whom were taking background pulmonary arterial hypertension therapy, tended to be lower than that predicted for all SERAPHIN patients (16% lower; P=0.259). The observed placebo survival curve closely approximated the predicted survival curve for the first 15 months. Beyond that time, observed risk of mortality decreased compared with predicted mortality, potentially reflecting the impact of crossover of patients in the placebo group to active therapy. Over 3 years, risk of mortality observed with macitentan 10 mg was 35% lower than predicted mortality ( P=0.010). Conclusions These analyses show that, in a rare disease, real-world observational data can complement randomized controlled trial data to overcome some challenges associated with assessing survival in the setting of a randomized controlled trial. Clinical Trial Registration https://www.clinicaltrials.gov . Unique identifiers: NCT00660179 and NCT00370214.",2019,"Over 3 years, risk of mortality observed with macitentan 10 mg was 35% lower than predicted mortality ( P=0.010).","['treated patients who clinically deteriorate', '734 patients who met SERAPHIN eligibility criteria']","['Endothelin Receptor Antagonist', 'placebo']","['mortality risk', 'survival curve', 'risk of mortality']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1134681', 'cui_str': 'Endothelin Antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.341133,"Over 3 years, risk of mortality observed with macitentan 10 mg was 35% lower than predicted mortality ( P=0.010).","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Torbicki', 'Affiliation': 'Department of Pulmonary Circulation and Thromboembolic Diseases and Cardiology, Centre of Postgraduate Medical Education, European Health Centre, ECZ-Otwock, Poland (A.T.).'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Bacchi', 'Affiliation': 'Biostatistics, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland (M.B., B.H.).'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Delcroix', 'Affiliation': 'Department of Pneumology, University Hospitals Leuven, Belgium (M.D.).'}, {'ForeName': 'Harrison W', 'Initials': 'HW', 'LastName': 'Farber', 'Affiliation': 'Pulmonary Center, Boston University School of Medicine, MA (H.W.F.).'}, {'ForeName': 'Hossein-Ardeschir', 'Initials': 'HA', 'LastName': 'Ghofrani', 'Affiliation': 'University of Giessen and Marburg Lung Center, Germany, member of the German Center of Lung Research, and Department of Medicine, Imperial College London, United Kingdom (H.-A.G.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hennessy', 'Affiliation': 'Biostatistics, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland (M.B., B.H.).'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Jansa', 'Affiliation': 'Clinicial Department of Cardiology and Angiology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic (P.J.).'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Canada Respirology Division, London Health Sciences Centre, ON (S.M.).'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Perchenet', 'Affiliation': 'Global Medical Affairs, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland (L.P.).'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Pulido', 'Affiliation': 'Cardiopulmonary Department, Ignacio Chávez National Heart Institute, Mexico City, Mexico (T.P.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rosenberg', 'Affiliation': 'Epidemiology & Observational Studies, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland (D.R.).'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Rubin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of California, San Diego Medical School (L.J.R.).'}, {'ForeName': 'B K S', 'Initials': 'BKS', 'LastName': 'Sastry', 'Affiliation': 'Division of Cardiology, CARE Hospitals, Hyderabad, India (B.K.S.S.).'}, {'ForeName': 'Gérald', 'Initials': 'G', 'LastName': 'Simonneau', 'Affiliation': ""APHP Centre de Référence de l'Hypertension Pulmonaire, Service de Pneumologie et Soins Intensifs, Université Paris-Sud, Hôpital de Bicêtre, Le Kremlin-Bicêtre, France (G.S., O.S.).""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sitbon', 'Affiliation': ""APHP Centre de Référence de l'Hypertension Pulmonaire, Service de Pneumologie et Soins Intensifs, Université Paris-Sud, Hôpital de Bicêtre, Le Kremlin-Bicêtre, France (G.S., O.S.).""}, {'ForeName': 'Rogério', 'Initials': 'R', 'LastName': 'Souza', 'Affiliation': 'INCOR Heart Institute, University of Sao Paulo, Brazil (R.S.).'}, {'ForeName': 'Lee-Jen', 'Initials': 'LJ', 'LastName': 'Wei', 'Affiliation': 'Department of Biostatistics, Harvard University, Boston, MA (L.-J.W.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Channick', 'Affiliation': 'University of California Los Angeles (R.C.).'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Benza', 'Affiliation': 'Division of Cardiovascular Diseases, Allegheny General Hospital, Pittsburgh, PA (R.B.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.118.005095']
1081,30805618,Using graphic text-messaging to promote smoking cessation among first-generation Chinese and Korean male immigrants.,"First-generation Chinese and Korean male immigrants in the United States are at high risk for tobacco use. This study pilot-tested a graphic, native-language text-messaging intervention to promote smoking cessation among these groups. First-generation Chinese and Korean male immigrant smokers (N = 71) were recruited from the Washington DC area. Participants were randomly assigned to one of four conditions based on a between-subjects 2 (graphic plus text or text-only messages) � 2 (quitline information or quitting tips) design. The text-messaging intervention included 30 text messages in total and lasted one month. Participants completed an expired air carbon monoxide (CO) assessment and self-reported measures at both baseline and follow-up. Results show that, from baseline to follow-up, participants' expired air CO levels decreased significantly (P = 0.001). Attitude toward quitting also became more positive (P = 0.028). Compared with text-only messages, graphic text messages produced greater positive changes in quitting attitudes (P = 0.039) and elicited greater fear response (P = 0.005). Compared with quitting tip messages, quitline information resulted in greater regret (P = 0.016) and fear (P = 0.051). These findings suggest that graphic text-messaging can be an effective method to promote smoking cessation among first-generation Chinese and Korean male immigrants.",2019,"Compared with quitting tip messages, quitline information resulted in greater regret (P = 0.016) and fear (P = 0.051).","['Korean male immigrants', 'first-generation Chinese and Korean male immigrants', 'First-generation Chinese and Korean male immigrant smokers (N = 71) were recruited from the Washington DC area']","['graphic text-messaging to promote smoking cessation', 'subjects 2 (graphic plus text or text-only messages) � 2 (quitline information or quitting tips) design', 'graphic, native-language text-messaging intervention']","['positive changes in quitting attitudes', 'expired air CO levels', 'expired air carbon monoxide (CO) assessment and self-reported measures', 'fear response']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",71.0,0.0427894,"Compared with quitting tip messages, quitline information resulted in greater regret (P = 0.016) and fear (P = 0.051).","[{'ForeName': 'Xiaoquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Communication, George Mason University, 4400 University Drive, Fairfax, VA, USA.'}, {'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Peterson', 'Affiliation': 'National Cancer Institute, 9609 Medical Center Drive, Bethesda, MD, USA.'}, {'ForeName': 'Kyeung Mi', 'Initials': 'KM', 'LastName': 'Oh', 'Affiliation': 'School of Nursing, George Mason University, 4400 University Drive, Fairfax, VA, USA.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Department of Communication, George Mason University, 4400 University Drive, Fairfax, VA, USA.'}]",Health education research,['10.1093/her/cyz006']
1082,31982219,"Is it feasible ""scoop and run while playing"" resuscitation on a rescue water craft? A randomized simulation study with lifeguards.","OBJECTIVE


Response time is a predictive factor for survival of drowning victims and lifesaving. Rescue Water Craft (RWC) are lifeboats very common in lifeguards operations. The aim of this study was to analyze the feasibility of providing effective mouth-to-mouth ventilations and/or cardiopulmonary resuscitation (CPR) on the RWC while sailing at different speeds.
METHOD


A quasi-experimental cross-over block design was used to test during one minute efforts the effectiveness of Mouth to Mouth ventilation (MM-only) and CRP, at the beach and sailing at two diferents speeds 5 knots(kn) and 10 kn with calm sea. Quality CPR reference were 2015 ERC guidelines.
RESULTS


The data obtained from 13 lifeguards were included, that means that 78 resuscitation test were completed. The MM-only performance skills reached 69.7% ± 40.4 for 5 kn and 60.0% ± 41.8 for 10 kn (p = .59). For full CPR, performance was 74.4% ± 24.2 and 68.5% ± 23.9 respectively. Quality of MM and CPR decreased, not significantly, while sailing at 5 kn and 10 kn [(Q-MM; 5 kn: 59.9% ± 37.8 vs. 10 kn: 43.2% ± 41.4, p = .42)(Q-CPR; 5 kn: 64.8% ± 21.2 and 10 kn: 60.6% ± 21.0, p = .44)]. MM-only and CC variables were significantly worse on RJS when compared with resuscitation at the beach (p < .05). A trend for better results by lifeguards previously training on RJS was observed.
CONCLUSIONS


Resuscitation techniques on board of a RWC are feasible and therefore they could be an option for lifeguards when their training, sea conditions, distance and the victim's characteristics allow it. CPR maneuvers may be highly effective at 10 kn, both for MM-only and CPR, however, the quality of the ventilations dramatically worsen with increasing speed.",2020,"For full CPR, performance was 74.4% ± 24.2 and 68.5% ± 23.9 respectively.","['13 lifeguards were included, that means that 78 resuscitation test were completed']","['mouth ventilations and/or cardiopulmonary resuscitation (CPR', 'Mouth to Mouth ventilation (MM-only) and CRP, at the beach and sailing at two diferents speeds 5 knots(kn) and 10 kn with calm sea', 'Rescue Water Craft (RWC']","['MM-only performance skills', 'Quality of MM and CPR', 'Quality CPR reference']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0331781', 'cui_str': 'Beach (environment)'}, {'cui': 'C0522727', 'cui_str': 'Sailing'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}]",,0.0407647,"For full CPR, performance was 74.4% ± 24.2 and 68.5% ± 23.9 respectively.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Barcala-Furelos', 'Affiliation': 'REMOSS Research Group, International Drowning Research Alliance-IDRA (Spain), Faculty of Education and Sport Sciences, Universidade de Vigo, Spain; CLINURSID Research Group, Psychiatry, Radiology, Public Health, Nursing and Medicine Departament, Universidade de Santiago de Compostela, Santiago de Compostela, Galicia, Spain. Electronic address: roberto.barcala@uvigo.es.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Abelairas-Gomez', 'Affiliation': 'CLINURSID Research Group, Psychiatry, Radiology, Public Health, Nursing and Medicine Departament, Universidade de Santiago de Compostela, Santiago de Compostela, Galicia, Spain; Faculty of Education, Universidade de Santiago de Compostela, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Aranda-García', 'Affiliation': ""GRAFiS Research Group, Institut Nacional d'Educació Física de Catalunya, Universitat de Barcelona (UB), Barcelona, Spain.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Lorenzo-Martínez', 'Affiliation': 'REMOSS Research Group, International Drowning Research Alliance-IDRA (Spain), Faculty of Education and Sport Sciences, Universidade de Vigo, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Martínez-Isasi', 'Affiliation': 'CLINURSID Research Group, Psychiatry, Radiology, Public Health, Nursing and Medicine Departament, Universidade de Santiago de Compostela, Santiago de Compostela, Galicia, Spain.'}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Durán-Álvarez', 'Affiliation': 'Noia Health Center, SERGAS, Noia, A Coruña, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Palacios-Aguilar', 'Affiliation': 'Faculty of Sport Sciences and Physical Activity, Universidade da Coruña, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rodríguez-Núñez', 'Affiliation': 'CLINURSID Research Group, Psychiatry, Radiology, Public Health, Nursing and Medicine Departament, Universidade de Santiago de Compostela, Santiago de Compostela, Galicia, Spain.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.10.045']
1083,30291532,Investigating the Effect of Religious Intervention on Mental Vitality and Sense of Loneliness Among the Elderly Referring to Community Healthcare Centers.,"The growth of elderly population is among the most important issues in the world, and religious interventions can help them to keep their health. For this reason, this study was conducted with the aim of determining the effect of religious intervention on subjective vitality and sense of loneliness of the elderly referring to healthcare centers. This semi-experimental study was conducted on 88 elderlies referring to community healthcare centers of Ilam City. The elderlies were randomly assigned into test and control groups, and subjective vitality and sense of loneliness questionnaire was distributed to them. For the elderly in the test group, twelve 30-45-min sessions of religious intervention were held. Then, at intervals of immediately, 1 month, and 2 months after the study, the studied questionnaires were redistributed again among the elderly, and the data were analyzed using SPSS 16 and through descriptive statistics as well as repeated measures of analysis of variance. Before intervention, there was no difference between mental vitality and fear of loneliness in the elderly, but after intervention, the amount of mental vitality increased and fear of loneliness decreased. Since in this study, implementation of religious intervention resulted in improved subjective vitality and diminished sense of loneliness among the elderly, it is suggested that this effective intervention be also used in other studies.",2020,"Before intervention, there was no difference between mental vitality and fear of loneliness in the elderly, but after intervention, the amount of mental vitality increased and fear of loneliness decreased.","['88 elderlies referring to community healthcare centers of Ilam City', 'elderly referring to healthcare centers', 'Elderly Referring to Community Healthcare Centers']","['Religious Intervention', 'religious intervention']","['mental vitality and fear of loneliness', 'subjective vitality and sense of loneliness', 'Mental Vitality and Sense of Loneliness', 'subjective vitality and sense of loneliness questionnaire', 'subjective vitality', 'amount of mental vitality increased and fear of loneliness']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086034', 'cui_str': 'Community Health Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C0557075', 'cui_str': 'Has religious belief (finding)'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0023974', 'cui_str': 'Loneliness'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",88.0,0.0152756,"Before intervention, there was no difference between mental vitality and fear of loneliness in the elderly, but after intervention, the amount of mental vitality increased and fear of loneliness decreased.","[{'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Borji', 'Affiliation': 'Nursing and Midwifery School, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Tarjoman', 'Affiliation': 'Student Research Committee, Ilam University of Medical Sciences, Ilam, Iran. Asmatarjoman@yahoo.com.'}]",Journal of religion and health,['10.1007/s10943-018-0708-x']
1084,31981558,Cause-specific mortality of children younger than 5 years in communities receiving biannual mass azithromycin treatment in Niger: verbal autopsy results from a cluster-randomised controlled trial.,"BACKGROUND


The Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) trial found that biannual mass distribution of azithromycin to children younger than 5 years in Niger reduced the primary outcome of all-cause mortality by 18%. We aimed to determine the causes of mortality among deceased children using verbal autopsy.
METHODS


In this 2-year cluster-randomised controlled trial, 594 community clusters in Niger were randomly allocated (1:1 ratio) to receive biannual mass distributions of either oral azithromycin (approximately 20 mg per kg of bodyweight) or placebo targeted to children aged 1-59 months. Participants, study investigators, and field workers were masked to treatment allocation. Between Nov 23, 2014, and July 31, 2017, 3615 child deaths were recorded by use of biannual house-to-house censuses, and verbal autopsies were done between May 26, 2015, and May 17, 2018, to identify cause of death. Cause-specific mortality, as assessed by verbal autopsy, was a prespecified secondary outcome. This trial is completed and is registered with ClinicalTrials.gov, NCT02047981.
FINDINGS


Between Nov 23, 2014, and July 31, 2017, 303 communities (n=40 375 children at baseline) in Niger received mass azithromycin and 291 communities (n=35 747 children at baseline) received placebo. Treatment coverage was 90·3% (SD 10·6) in the azithromycin group and 90·4% (10·1) in the placebo group. No communities were lost to follow-up. In total, 1727 child deaths in the azithromycin group and 1888 child deaths in the placebo group were reported from the population censuses. Of these, the cause of death for 1566 (90·7%) children in the azithromycin group and 1735 (91·9%) children in the placebo group were ascertained by verbal autopsy interviews. In the azithromycin group, 437 (27·9%) deaths were due to malaria, 252 (16·1%) deaths were due to pneumonia, and 234 (14·9%) deaths were due to diarrhoea. In the placebo group, 493 (28·4%) deaths were due to malaria, 275 (15·9%) deaths were due to pneumonia, and 251 (14·5%) deaths were due to diarrhoea. Relative to communities that received placebo, child mortality in communities that received azithromycin was lower for malaria (incidence rate ratio 0·78, 95% CI 0·66-0·92; p=0·0029), dysentery (0·65, 0·44-0·94; p=0·025), meningitis (0·67, 0·46-0·97; p=0·036), and pneumonia (0·83, 0·68-1·00; p=0·051). The distribution of causes of death did not differ significantly between the two study groups (p=0·98).
INTERPRETATION


Mass azithromycin distribution resulted in approximately a third fewer deaths in children aged 1-59 months due to meningitis and dysentery, and a fifth fewer deaths due to malaria and pneumonia. The lack of difference in the distribution of causes of death between the azithromycin and placebo groups could be attributable to the broad spectrum of azithromycin activity and the study setting, in which most childhood deaths were due to infections.
FUNDING


Bill & Melinda Gates Foundation.",2020,"Relative to communities that received placebo, child mortality in communities that received azithromycin was lower for malaria (incidence rate ratio 0·78, 95% CI 0·66-0·92; p=0·0029), dysentery (0·65, 0·44-0·94; p=0·025), meningitis (0·67, 0·46-0·97; p=0·036), and pneumonia (0·83, 0·68-1·00; p=0·051).","['deceased children using verbal autopsy', 'Between Nov 23, 2014, and July 31, 2017, 3615 child deaths', '594 community clusters in Niger', 'Between Nov 23, 2014, and July 31, 2017', ' 303 communities (n=40\u2008375 children at baseline) in Niger received mass', 'children younger than 5 years in communities receiving', 'and 291 communities (n=35\u2008747 children at baseline) received']","['oral azithromycin', 'placebo', 'azithromycin', 'biannual mass azithromycin']","['distribution of causes of death', 'Cause-specific mortality']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0004398', 'cui_str': 'Postmortem Examination'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0007465', 'cui_str': 'Cause of Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",594.0,0.47897,"Relative to communities that received placebo, child mortality in communities that received azithromycin was lower for malaria (incidence rate ratio 0·78, 95% CI 0·66-0·92; p=0·0029), dysentery (0·65, 0·44-0·94; p=0·025), meningitis (0·67, 0·46-0·97; p=0·036), and pneumonia (0·83, 0·68-1·00; p=0·051).","[{'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA; Department of Ophthalmology, University of California, San Francisco, CA, USA. Electronic address: jeremy.keenan@ucsf.edu.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Sanoussi', 'Initials': 'S', 'LastName': 'Elh Adamou', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Ibrahim', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Mariama', 'Initials': 'M', 'LastName': 'Kiemago', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Nana Fatima', 'Initials': 'NF', 'LastName': 'Galo', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Vanderschelden', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA; Department of Ophthalmology, University of California, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA; Department of Ophthalmology, University of California, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(19)30540-6']
1085,31981370,Prospective Associations Between Diffusion Tensor Imaging Parameters and Frailty in Older Adults.,"BACKGROUND


Cross-sectional associations have been found between frail individuals and worse white matter (WM) integrity. However, the prospective association between WM integrity and frailty is still unclear. Our objectives were to measure associations between WM integrity using diffusion tensor imaging (DTI) and the 5-year worsening of frailty in community-dwelling older adults.
DESIGN


Secondary analysis of the randomized controlled Multidomain Alzheimer Preventive Trial (MAPT).
SETTING


Thirteen memory centers in France and Monaco between 2008 and 2011.
PARTICIPANTS


Participants (mean age = 74.7 ± 3.9 years) with no dementia at baseline who had functional magnetic resonance imaging performed as part of the MAPT study (n = 227).
MEASUREMENTS


Fractional anisotropy and mean diffusivity (MD), axial diffusivity (AxD), and radial diffusivity (RD) were acquired for 10 different brain regions. Frailty was assessed by the Fried frailty phenotype (score from 0 to 5, higher is worse) at up to seven time points for 5 years. Mixed effect ordinal logistic regression model was used to assess the prospective association between DTI parameters (independent variables) and frailty (dependent variable). All the analyses were adjusted for age, sex, baseline total intracranial volume, and the presence of one of the following cardiovascular risk factors (hypertension, diabetes, and/or hypercholesterolemia).
RESULTS


A statistically significant association was found between the RD, AxD, and MD for different brain regions (anterior limb of internal capsule, external capsule, posterior corona radiata, posterior thalamic radiation, superior corona radiata, superior frontal occipital fasciculus, and superior longitudinal fasciculus) and worsening of frailty over 5 years after adjusting for multiple comparisons.
CONCLUSIONS


This is the first study to show that WM integrity is associated with frailty in older adults. The mechanisms related to these results require further investigation. J Am Geriatr Soc 68:1050-1055, 2020.",2020,"A statistically significant association was found between the RD, AxD, and MD for different brain regions (anterior limb of internal capsule, external capsule, posterior corona radiata, posterior thalamic radiation, superior corona radiata, superior frontal occipital fasciculus, and superior longitudinal fasciculus) and worsening of frailty over 5 years after adjusting for multiple comparisons.
","['community-dwelling older adults', 'Older Adults', 'Participants (mean age = 74.7\u2009±\u20093.9\u2009years) with no dementia at baseline who had functional magnetic resonance imaging performed as part of the MAPT study (n = 227', 'frail individuals and worse white matter (WM) integrity', 'Thirteen memory centers in France and Monaco between 2008 and 2011', 'older adults']",['diffusion tensor imaging (DTI'],"['Fractional anisotropy and mean diffusivity (MD), axial diffusivity (AxD), and radial diffusivity (RD', 'RD, AxD, and MD for different brain regions (anterior limb of internal capsule, external capsule, posterior corona radiata, posterior thalamic radiation, superior corona radiata, superior frontal occipital fasciculus, and superior longitudinal fasciculus) and worsening of frailty']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0682708'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0026405', 'cui_str': 'Monaco'}]","[{'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}]","[{'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0152342', 'cui_str': 'Internal capsule anterior limb structure'}, {'cui': 'C0152345', 'cui_str': 'Capsula Externa'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0228270', 'cui_str': 'Structure of superior longitudinal fasciculus'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}]",,0.0246124,"A statistically significant association was found between the RD, AxD, and MD for different brain regions (anterior limb of internal capsule, external capsule, posterior corona radiata, posterior thalamic radiation, superior corona radiata, superior frontal occipital fasciculus, and superior longitudinal fasciculus) and worsening of frailty over 5 years after adjusting for multiple comparisons.
","[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Maltais', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'de Souto Barreto', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Perus', 'Affiliation': ""Memory Resources and Research Center, Montpellier University Hospital, INSERM U1061, University of Montpellier i-Site Montpellier Université d'Excellence (MUSE), Montpellier, France.""}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Mangin', 'Affiliation': ""CATI Multicenter Neuroimaging Platform, Neurospin, Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Paris Saclay University, Gif sur Yvette, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Grigis', 'Affiliation': ""CATI Multicenter Neuroimaging Platform, Neurospin, Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Paris Saclay University, Gif sur Yvette, France.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Chupin', 'Affiliation': ""CATI Multicenter Neuroimaging Platform, Neurospin, Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Paris Saclay University, Gif sur Yvette, France.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bouyahia', 'Affiliation': ""CATI Multicenter Neuroimaging Platform, Neurospin, Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Paris Saclay University, Gif sur Yvette, France.""}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Gabelle', 'Affiliation': ""Memory Resources and Research Center, Montpellier University Hospital, INSERM U1061, University of Montpellier i-Site Montpellier Université d'Excellence (MUSE), Montpellier, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Delrieux', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Geriatrics Society,['10.1111/jgs.16343']
1086,30898253,Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon.,"OBJECTIVES


The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB).
BACKGROUND


Treatment of coronary in-stent restenosis (ISR) remains challenging. PCBs are an established treatment option outside the United States with a Class I, Level of Evidence: A recommendation in the European guidelines. However, their efficacy is better in bare-metal stent (BMS) ISR compared with drug-eluting stent (DES) ISR.
METHODS


Fifty patients with DES ISR were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, 4 μg/mm 2 ) with a clinically proven PCB (SeQuent Please Neo, 3 μg/mm 2 ) in coronary DES ISR. The primary endpoint was angiographic late lumen loss at 6 months. Secondary endpoints included procedural success, major adverse cardiovascular events, and individual clinical endpoints such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis.
RESULTS


Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.21 ± 0.54 mm in the PCB group versus 0.17 ± 0.55 mm in the SCB group (p = NS; per-protocol analysis). Clinical events up to 12 months also did not differ between the groups.
CONCLUSIONS


This first-in-man comparison of a novel SCB with a crystalline coating shows similar angiographic outcomes in the treatment of coronary DES ISR compared with a clinically proven PCB. (Treatment of Coronary In-Stent Restenosis by a Sirolimus [Rapamycin] Coated Balloon or a Paclitaxel Coated Balloon [FIM LIMUS DCB]; NCT02996318).",2019,"Clinical events up to 12 months also did not differ between the groups.
",['Fifty patients with DES ISR'],"['bare-metal stent (BMS', 'novel SCB (SeQuent SCB, 4 μg/mm 2 ) with a clinically proven PCB (SeQuent Please Neo, 3 μg/mm 2 ) in coronary DES ISR', 'PCB', 'paclitaxel-coated balloon (PCB', 'Sirolimus [Rapamycin] Coated Balloon or a Paclitaxel Coated Balloon', 'drug-eluting stent (DES) ISR', 'novel sirolimus-coated balloon (SCB', 'SCB', 'Sirolimus- or Paclitaxel-Coated Balloon']","['angiographic late lumen loss', 'ISR', 'procedural success, major adverse cardiovascular events, and individual clinical endpoints such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2825200', 'cui_str': 'Bare metal stent (physical object)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0032447', 'cui_str': 'PCBs'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}]",50.0,0.103664,"Clinical events up to 12 months also did not differ between the groups.
","[{'ForeName': 'Rosli Mohd', 'Initials': 'RM', 'LastName': 'Ali', 'Affiliation': 'Cardiac Vascular Sentral Kuala Lumpur, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Muhamad Ali S K', 'Initials': 'MASK', 'LastName': 'Abdul Kader', 'Affiliation': 'Cardiology Department, Hospital Pulau Pinang, George Town, Malaysia.'}, {'ForeName': 'Wan Azman', 'Initials': 'WA', 'LastName': 'Wan Ahmad', 'Affiliation': 'Cardiology Department, University Malaya Medical Center, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Tiong Kiam', 'Initials': 'TK', 'LastName': 'Ong', 'Affiliation': 'Cardiology Department, Sarawak Heart Centre, Kota Samarahan, Malaysia.'}, {'ForeName': 'Houng Bang', 'Initials': 'HB', 'LastName': 'Liew', 'Affiliation': 'Cardiology Department and Clinical Research Center, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia.'}, {'ForeName': 'Al-Fazir', 'Initials': 'AF', 'LastName': 'Omar', 'Affiliation': 'Cardiology Department, National Heart Institute Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Ahmad Syadi', 'Initials': 'AS', 'LastName': 'Mahmood Zuhdi', 'Affiliation': 'Cardiology Department, University Malaya Medical Center, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Amin Ariff', 'Initials': 'AA', 'LastName': 'Nuruddin', 'Affiliation': 'Cardiology Department, National Heart Institute Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Schnorr', 'Affiliation': 'Experimental Radiology, Charité, Berlin, Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Scheller', 'Affiliation': 'Cardiology Department, University Hospital of Saarland, Homburg/Saar, Germany. Electronic address: bruno.scheller@uks.eu.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2018.11.040']
1087,31977640,Pectin-Alginate Does Not Further Enhance Exogenous Carbohydrate Oxidation in Running.,"PURPOSE


Maximizing carbohydrate availability is important for many endurance events. Combining pectin and sodium alginate with ingested maltodextrin-fructose (MAL + FRU + PEC + ALG) has been suggested to enhance carbohydrate delivery via hydrogel formation, but the influence on exogenous carbohydrate oxidation remains unknown. The primary aim of this study was to assess the effects of MAL + FRU + PEC + ALG on exogenous carbohydrate oxidation during exercise compared with a maltodextrin-fructose mixture (MAL + FRU). MAL + FRU has been well established to increase exogenous carbohydrate oxidation during cycling compared with glucose-based carbohydrates (MAL + GLU). However, much evidence focuses on cycling, and direct evidence in running is lacking. Therefore, a secondary aim was to compare exogenous carbohydrate oxidation rates with MAL + FRU versus MAL + GLU during running.
METHODS


Nine trained runners completed two trials (MAL + FRU and MAL + FRU + PEC + ALG) in a double-blind, randomized crossover design. A subset (n = 7) also completed a MAL + GLU trial to address the secondary aim, and a water trial to establish background expired CO2 enrichment. Participants ran at 60% V˙O2peak for 120 min while ingesting either water only or carbohydrate solutions at a rate of 1.5 g carbohydrate per minute.
RESULTS


At the end of 120 min of exercise, exogenous carbohydrate oxidation rates were 0.9 (SD 0.5) g·min with MAL + GLU ingestion. MAL + FRU ingestion increased exogenous carbohydrate oxidation rates to 1.1 (SD 0.3) g·min (P = 0.038), with no further increase with MAL + FRU + PEC + ALG ingestion (1.1 (SD 0.3) g·min; P = 1.0). No time-treatment interaction effects were observed for plasma glucose, lactate, insulin, or nonesterified fatty acids, or for ratings of perceived exertion or gastrointestinal symptoms (all, P > 0.05).
CONCLUSION


To maximize exogenous carbohydrate oxidation during moderate-intensity running, athletes may benefit from consuming glucose(polymer)-fructose mixtures over glucose-based carbohydrates alone, but the addition of pectin and sodium alginate offers no further benefit.",2020,"No time x treatment interaction effects were observed for plasma glucose, lactate, insulin or non-esterified fatty acids, nor for ratings of perceived exertion or gastrointestinal symptoms (all p>0.05).
",['Nine trained runners completed two trials'],"['Pectin-Alginate', 'maltodextrin-fructose mixture (MAL+FRU', 'MAL+FRU versus MAL+GLU', 'MAL+FRU+PEC+ALG', 'MAL+FRU', 'pectin and sodium alginate with ingested maltodextrin-fructose (MAL+FRU+PEC+ALG', 'MAL+FRU ingestion', 'MAL+FRU and MAL+FRU+PEC+ALG']","['Exogenous Carbohydrate Oxidation', 'exogenous carbohydrate oxidation rates', 'exogenous carbohydrate oxidation', 'plasma glucose, lactate, insulin or non-esterified fatty acids, nor for ratings of perceived exertion or gastrointestinal symptoms']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0070203', 'cui_str': 'pectin'}, {'cui': 'C0102137', 'cui_str': 'alginate'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0142791', 'cui_str': 'Sodium alginate'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0369212', 'cui_str': 'Fatty Acids, Esterified'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]",,0.0628111,"No time x treatment interaction effects were observed for plasma glucose, lactate, insulin or non-esterified fatty acids, nor for ratings of perceived exertion or gastrointestinal symptoms (all p>0.05).
","[{'ForeName': 'James F P', 'Initials': 'JFP', 'LastName': 'Barber', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Narang', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Gareth A', 'Initials': 'GA', 'LastName': 'Wallis', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UNITED KINGDOM.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002262']
1088,31981557,Effect of facility-based HIV self-testing on uptake of testing among outpatients in Malawi: a cluster-randomised trial.,"BACKGROUND


HIV self-testing increases testing uptake in sub-Saharan Africa but scale-up is challenging because of resource constraints. We evaluated an HIV self-testing intervention integrated into high-burden outpatient departments in Malawi.
METHODS


In this cluster-randomised trial, we recruited participants aged 15 years or older from 15 outpatient departments at high-burden health facilities (including health centres, mission hospitals, and district hospitals) in central and southern Malawi. The trial was clustered at the health facility level. We used constrained randomisation to allocate each cluster (1:1:1) to one of the following groups: standard provider-initiated testing and counselling with no intervention (provider offered during consultations), optimised provider-initiated testing and counselling (with additional provider training and morning HIV testing), and facility-based HIV self-testing (Oraquick HIV self-test, group demonstration and distribution, and private spaces for interpretation and counselling). The primary outcome was the proportion of outpatients tested for HIV on the day of enrolment, measured through exit surveys with a sample of outpatients. Analyses were on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316.
FINDINGS


Between Sept 12, 2017, and Feb 23, 2018, 5885 outpatients completed an exit survey-2097 in the HIV self-testing group, 1951 in the standard provider-initiated testing and counselling group, and 1837 in the optimised provider-initiated testing and counselling group. 1063 (51%) of 2097 patients in the HIV self-testing group had HIV testing on the same day as enrolment, compared with 248 (13%) of 1951 in the standard provider-initiated testing and counselling group and 261 (14%) of 1837 in the optimised provider-initiated testing and counselling group. The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38). Around 4% of those tested in the standard provider-initiated testing and counselling and optimised provider-initiated testing and counselling groups felt coerced to test, and around 1% felt coerced to share test results. No coercion was reported in the facility-based HIV self-testing group.
INTERPRETATION


Facility-based HIV self-testing increased HIV testing among outpatients in Malawi, with a minimal risk of adverse events. Facility-based HIV self-testing should be considered for scale-up in settings with a high unmet need for HIV testing.
FUNDING


United States Agency for International Development.",2020,"The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38).","['outpatients in Malawi, with a minimal risk of adverse events', 'participants aged 15 years or older from 15 outpatient departments at high-burden health facilities (including health centres, mission hospitals, and district hospitals) in central and southern Malawi', '5885 outpatients completed an exit survey-2097 in the HIV self-testing group, 1951 in the standard provider-initiated testing and counselling group, and 1837 in the optimised provider-initiated testing and counselling group', '1063 (51%) of 2097 patients in the HIV self-testing group had HIV testing on the same day as enrolment, compared with 248 (13%) of 1951 in the standard provider-initiated testing and counselling group and 261 (14%) of 1837 in the optimised provider-initiated testing and counselling group', 'outpatients in Malawi', 'high-burden outpatient departments in Malawi']","['facility-based HIV self-testing', 'standard provider-initiated testing and counselling with no intervention (provider offered during consultations), optimised provider-initiated testing and counselling (with additional provider training and morning HIV testing), and facility-based HIV self-testing (Oraquick HIV self-test, group demonstration and distribution, and private spaces for interpretation and counselling']",['proportion of outpatients tested for HIV'],"[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0020006', 'cui_str': 'Hospitals, District'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1321876', 'cui_str': 'Human immunodeficiency virus test (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",5885.0,0.0574598,"The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38).","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Dovel', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA; Partners in Hope, Lilongwe, Malawi. Electronic address: kdovel@mednet.ucla.edu.'}, {'ForeName': 'Frackson', 'Initials': 'F', 'LastName': 'Shaba', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'O Agatha', 'Initials': 'OA', 'LastName': 'Offorjebe', 'Affiliation': 'Department of Medicine and David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA; School of Medicine, Charles R Drew University of Medicine and Science, Los Angeles, CA, USA.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Balakasi', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Phiri', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Sundeep K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Wong', 'Affiliation': 'USAID Global Health Bureau, Washington, DC, USA.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Brooke E', 'Initials': 'BE', 'LastName': 'Nichols', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Global Health, School of Public Health, Boston University, Boston, MA, USA.'}, {'ForeName': 'Refiloe', 'Initials': 'R', 'LastName': 'Cele', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lungu', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Masina', 'Affiliation': 'Malawi Ministry of Health, HIV/AIDS Unit, Lilongwe, Malawi.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Coates', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Risa M', 'Initials': 'RM', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30534-0']
1089,30583121,Effects of antibiotic prophylaxis on ventilator-associated pneumonia in severe traumatic brain injury. A post hoc analysis of two trials.,"PURPOSE


To investigate the role of antibiotic prophylaxis (AP) in the incidence of ventilator-associated pneumonia (VAP) in patients suffering from traumatic brain injury (TBI).
MATERIALS AND METHODS


This post hoc analysis was conducted based on data from 2 multicentre double-blind studies that aimed to prevent VAP using hydrocortisone or povidone iodine. Data from TBI patients were extracted and pooled. Patients were classified into 2 groups: those who received an AP (AP group) and those who did not (control group).
RESULTS


295 patients were included (AP group, n = 146; control group, n = 149). The incidence of VAP was 145 (49%). VAP incidence was lower in the AP group (39% vs 59%, Relative Risk = 0.33, 95%CI, 0.19-0.56, p = 0.001). Time to VAP occurrence was delayed (Hazard Ratio = 0.50, 95%CI 0.36-0.69, p < 0.001). The incidence of early VAP (>2 and ≤ 5 days) was lower in the AP group (10% vs 32%; p < 0.001), whereas that of late VAP (>5 days) did not differ (AP group 29% vs control group 28%; p = 0.811). Length of stay and mortality did not differ between the 2 groups.
CONCLUSIONS


Early use of AP delayed and may prevent the occurrence of VAP in severe TBI patients but did not change length of stay or mortality.",2019,"VAP incidence was lower in the AP group (39% vs 59%, Relative Risk = 0.33, 95%CI, 0.19-0.56, p = 0.001).","['severe traumatic brain injury', '295 patients were included (AP group, n\u202f=\u202f146; control group, n\u202f=\u202f149', 'Patients were classified into 2 groups: those who received an AP (AP group) and those who did not (control group', 'patients suffering from traumatic brain injury (TBI', 'severe TBI patients']","['antibiotic prophylaxis (AP', 'antibiotic prophylaxis', 'hydrocortisone or povidone iodine']","['Length of stay and mortality', 'VAP incidence', 'Time to VAP occurrence', 'change length of stay or mortality', 'incidence of VAP', 'occurrence of VAP', 'incidence of early VAP']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",295.0,0.195938,"VAP incidence was lower in the AP group (39% vs 59%, Relative Risk = 0.33, 95%CI, 0.19-0.56, p = 0.001).","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Reizine', 'Affiliation': 'CHU Rennes, Service de Réanimation Chirurgicale, Hôpital Pontchaillou, 2 rue Henri Le Guilloux, Rennes 35000, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': ""Département d'Anesthésie Réanimation, CHU Nantes, 1 Place Alexis-Ricordeau, Nantes 44000, France. Electronic address: karim.asehnoune@chu-nantes.fr.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Roquilly', 'Affiliation': ""Département d'Anesthésie Réanimation, CHU Nantes, 1 Place Alexis-Ricordeau, Nantes 44000, France. Electronic address: antoine.roquilly@chu-nantes.fr.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Laviolle', 'Affiliation': ""CHU de Rennes, Centre d'Investigation Clinique, 2 rue Henri Le Guilloux, Rennes 35000, France. Electronic address: bruno.laviolle@chu-rennes.fr.""}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Rousseau', 'Affiliation': ""CHU de Rennes, Centre d'Investigation Clinique, 2 rue Henri Le Guilloux, Rennes 35000, France. Electronic address: chloe.rousseau@chu-rennes.fr.""}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Arnouat', 'Affiliation': 'CHU Rennes, Service de Réanimation Chirurgicale, Hôpital Pontchaillou, 2 rue Henri Le Guilloux, Rennes 35000, France. Electronic address: matthieu.arnouat@chu-rennes.fr.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dahyot-Fizelier', 'Affiliation': ""Département d'Anesthésie Réanimation, CHU Poitiers, 2 Rue de la Milétrie, Poitiers 16000, France. Electronic address: claire.dahyot-fizelier@chu-rennes.fr.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Seguin', 'Affiliation': 'CHU Rennes, Service de Réanimation Chirurgicale, Hôpital Pontchaillou, 2 rue Henri Le Guilloux, Rennes 35000, France. Electronic address: philippe.seguin@chu-rennes.fr.'}]",Journal of critical care,['10.1016/j.jcrc.2018.12.010']
1090,30753449,A community intervention study on patients' resuscitation and defibrillation quality after embedded training in a cardiac rehabilitation program.,"The aim of this study was to examine the effectiveness of a novel cardiopulmonary resuscitation (CPR) training method embedded in a cardiac rehabilitation program at enhancing patients' CPR and defibrillation skills. One hundred and fourteen participants with coronary heart disease enrolled on an exercise-based cardiac rehabilitation program were included. Two groups were randomly allocated to different training programs: CPR-retraining based on hands-on rolling refreshers during the 2-month program (G-CPR, n = 53) versus standard one-time training (G-Stan, n = 61). Resuscitation and defibrillation skills and self-confidence were evaluated at baseline, following brief basic life support (BLS) instruction and after the distinct training programs. Baseline skills were equally poor, improving significantly although irregularly after brief instruction. After the program, CPR quality was further enhanced in G-CPR, which achieved better results regarding correct compressions by depth, rate, hands position and global CPR quality (P < 0.01, all analysis). Defibrillation skills improved similarly after instruction and were reasonably maintained after the program, although delay to shock was reduced in G-CPR. CPR self-confidence was superior in G-CPR (P < 0.001). In conclusion, CPR hands-on rolling refreshers embedded into an exercise-based cardiac rehabilitation program enhanced patients' CPR and defibrillation skills and self-confidence to perform CPR at 2 months, compared with standard one-time training. This method could help to bring effective training to high-risk populations.",2019,"Defibrillation skills improved similarly after instruction and were reasonably maintained after the program, although delay to shock was reduced in G-CPR.","['One hundred and fourteen participants with coronary heart disease enrolled on an exercise-based cardiac rehabilitation program were included', ""patients' resuscitation and defibrillation quality after embedded training in a cardiac rehabilitation program""]","['novel cardiopulmonary resuscitation (CPR) training', 'training programs: CPR-retraining based on hands-on rolling refreshers during the 2-month program (G-CPR, n = 53) versus standard one-time training']","['delay to shock', 'CPR self-confidence', 'Resuscitation and defibrillation skills and self-confidence', 'Defibrillation skills', 'correct compressions by depth, rate, hands position and global CPR quality', 'CPR quality']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",114.0,0.0110417,"Defibrillation skills improved similarly after instruction and were reasonably maintained after the program, although delay to shock was reduced in G-CPR.","[{'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Gonzï Lez-Salvado', 'Affiliation': 'Cardiology Department, University Clinical Hospital of Santiago (CIBER-CV), Universidade de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Abelairas-Gï Mez', 'Affiliation': 'Institute of Health Research of Santiago de Compsotela (IDIS), Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Peï A-Gil', 'Affiliation': 'Cardiology Department, University Clinical Hospital of Santiago (CIBER-CV), Universidade de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Neiro-Rey', 'Affiliation': 'Cardiology Department, University Clinical Hospital of Santiago (CIBER-CV), Universidade de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Barcala-Furelos', 'Affiliation': 'Institute of Health Research of Santiago de Compsotela (IDIS), Spain.'}, {'ForeName': 'Josï Ramï N', 'Initials': 'JRN', 'LastName': 'Gonzï Lez-Juanatey', 'Affiliation': 'Cardiology Department, University Clinical Hospital of Santiago (CIBER-CV), Universidade de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rodrï Guez-Nï Ï Ez', 'Affiliation': 'Institute of Health Research of Santiago de Compsotela (IDIS), Spain.'}]",Health education research,['10.1093/her/cyz002']
1091,30929015,A culturally and linguistically salient pilot intervention to promote colorectal cancer screening among Latinos receiving care in a Federally Qualified Health Center.,"Despite established benefits, colorectal cancer (CRC) screening is underutilized among Latinos/Hispanics. We conducted a pilot 2-arm randomized controlled trial evaluating efficacy of two intervention conditions on CRC screening uptake among Latinos receiving care in community clinics. Participants (N = 76) were aged 50-75, most were foreign-born, preferred to receive their health information in Spanish, and not up-to-date with CRC screening. Participants were randomized to either a culturally linguistically targeted Spanish-language fotonovela booklet and DVD intervention plus fecal immunochemical test [FIT] (the LCARES, Latinos Colorectal Cancer Awareness, Research, Education and Screening intervention group); or a non-targeted intervention that included a standard Spanish-language booklet plus FIT (comparison group). Measures assessed socio-demographic variables, health literacy, CRC screening behavior, awareness and beliefs. Overall, FIT uptake was 87%, exceeding the National Colorectal Cancer Roundtable's goal of 80% by 2018. The LCARES intervention group had higher FIT uptake than did the comparison group (90% versus 83%), albeit not statistically significant (P = 0.379). The LCARES intervention group was associated with greater increases in CRC awareness (P = 0.046) and susceptibility (P = 0.013). In contrast, cancer worry increased more in the comparison group (P = 0.045). Providing educational materials and a FIT kit to Spanish-language preferring Latinos receiving care in community clinics is a promising strategy to bolster CRC screening uptake to meet national targets.",2019,The LCARES intervention group was associated with greater increases in CRC awareness (P = 0.046) and susceptibility (P = 0.013).,"['Latinos receiving care in community clinics', 'Latinos receiving care in a Federally Qualified Health Center', 'Spanish-language preferring Latinos receiving care in community clinics', 'Participants (N = 76) were aged 50-75, most were foreign-born, preferred to receive their health information in Spanish, and not up-to-date with CRC screening']","['culturally linguistically targeted Spanish-language fotonovela booklet and DVD intervention plus fecal immunochemical test [FIT] (the LCARES, Latinos Colorectal Cancer Awareness, Research, Education and Screening intervention group); or a non-targeted intervention that included a standard Spanish-language booklet plus FIT (comparison group']","['Overall, FIT uptake', 'cancer worry', 'higher FIT uptake', 'CRC awareness', 'socio-demographic variables, health literacy, CRC screening behavior, awareness and beliefs', 'CRC screening uptake']","[{'cui': 'C0587907', 'cui_str': 'Community clinic (environment)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0037750', 'cui_str': 'Spanish language (qualifier value)'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0037750', 'cui_str': 'Spanish language (qualifier value)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0035168'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",76.0,0.0357306,The LCARES intervention group was associated with greater increases in CRC awareness (P = 0.046) and susceptibility (P = 0.013).,"[{'ForeName': 'Clement K', 'Initials': 'CK', 'LastName': 'Gwede', 'Affiliation': 'Department of Health Behavior and Outcomes, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'Department of Oncologic Sciences, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Enmanuel A', 'Initials': 'EA', 'LastName': 'Chavarria', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, University of Texas Health Science Center at Houston, Brownsville Regional Campus, Brownsville, TX, USA.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Gutierrez', 'Affiliation': 'Department of Health Behavior and Outcomes, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Abdulla', 'Affiliation': 'Department of Health Behavior and Outcomes, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Christy', 'Affiliation': 'Department of Health Behavior and Outcomes, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lopez', 'Affiliation': 'Suncoast Community Health Centers, Inc., Brandon, FL, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Sanchez', 'Affiliation': 'Department of Health Behavior and Outcomes, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Cathy D', 'Initials': 'CD', 'LastName': 'Meade', 'Affiliation': 'Department of Health Behavior and Outcomes, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.'}]",Health education research,['10.1093/her/cyz010']
1092,31951260,Effectiveness of an Evidence-Based Amputee Rehabilitation Program: A Pilot Randomized Controlled Trial.,"BACKGROUND


Despite the prevalence of lower limb amputation (LLA), only a small percentage of people with LLA actually receive physical therapy post amputation and are rehabilitated to their full potential level of function. There is a need for the development of a rehabilitation program that targets impairments and limitations specific to people with LLA.
OBJECTIVE


The objective of this study was to determine whether the Evidence-Based Amputee Rehabilitation program would improve functional mobility of people with unilateral transtibial amputation (TTA) who have already completed physical therapy and prosthetic training.
DESIGN


This study was a randomized, wait-list control, single-blinded pilot clinical trial.
SETTING


This study researched participants who had received postamputation rehabilitation to varying degrees, either in an inpatient and/or outpatient settings.
PARTICIPANTS


The participants in this study included veterans and nonveterans with unilateral TTA due to dysvascular disease and trauma.
INTERVENTION


This study included a prescription-based rehabilitation program for people with amputations.
MEASUREMENTS


Results were measured with The Amputee Mobility Predictor with (AMPPro) and without a prosthesis (AMPnoPro) and 6-Minute Walk Test (6MWT) at baseline and at the end of the 8-week intervention.
RESULTS


The intervention group improved on the AMPPro scores (36.4 to 41.7), AMPnoro scores (23.2 to 27.1), and 6MWT distance (313.6 to 387.7 m). The effect size for the intervention was very large (1.32). In contrast, the wait-list control group demonstrated no change in AMPPro scores (35.3 to 35.6), AMPnoPro scores (24.7 to 25.0), and 6MWT distance (262.6 m to 268.8 m).
LIMITATIONS


The sample size was small. A total 326 potential candidates were screened with 306 unable to meet inclusion criteria or unwilling to participate.
CONCLUSION


People with unilateral TTA who received Evidence-Based Amputee Rehabilitation program demonstrated significant improvement in functional mobility, with most participants (66.7%) improved at least 1 K-level (58.3%) and greater than the minimal detectable change (66.7%).",2020,"The intervention group improved on the AMPPro scores (36.4 to 41.7), AMPnoro scores (23.2 to 27.1), and 6MWT distance (313.6 to 387.7 m).The effect size for the intervention was very large (1.32).","['participants who had received post amputation rehabilitation to varying degrees, either in an inpatient and/or outpatient settings', 'people with unilateral transtibial amputation (TTA) who have already completed physical therapy and prosthetic training', 'Three-hundred twenty-six potential candidates were screened with 306 unable to meet inclusion criteria or unwilling to participate', 'The participants in this study included veterans and non-veterans with unilateral TTA due to dysvascular disease and trauma', 'people with amputations']","['prescription-based rehabilitation program', 'Evidence-Based Amputee Rehabilitation (EBAR) program', 'EBAR program', 'Evidence-Based Amputee Rehabilitation (EBAR) Program']","['6MWT distance', 'functional mobility', 'AMPnoPro scores', 'Amputee Mobility Predictor with (AMPPro) and without a prosthesis (AMPnoPro) and 6-minute Walk Test (6MWT', 'AMPnoro scores', 'AMPPro scores']","[{'cui': 'C0204095', 'cui_str': 'Post-amputation rehabilitation (regime/therapy)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0558080', 'cui_str': 'Unwilling (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1627773', 'cui_str': 'Tissue texture abnormality'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0002695', 'cui_str': 'Amputees'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002695', 'cui_str': 'Amputees'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}]",306.0,0.112927,"The intervention group improved on the AMPPro scores (36.4 to 41.7), AMPnoro scores (23.2 to 27.1), and 6MWT distance (313.6 to 387.7 m).The effect size for the intervention was very large (1.32).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gailey', 'Affiliation': 'Department of Physical Therapy, University of Miami Miller School of Medicine, 5915 Ponce de Leon Boulevard, 5th Floor, Coral Gables, FL 33146 USA.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Gaunaurd', 'Affiliation': 'Department of Physical Therapy, University of Miami Miller School of Medicine, 5915 Ponce de Leon Boulevard, 5th Floor, Coral Gables, FL 33146 USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Raya', 'Affiliation': 'Department of Physical Therapy, University of Miami Miller School of Medicine, 5915 Ponce de Leon Boulevard, 5th Floor, Coral Gables, FL 33146 USA.'}, {'ForeName': 'Neva', 'Initials': 'N', 'LastName': 'Kirk-Sanchez', 'Affiliation': 'Department of Physical Therapy, University of Miami Miller School of Medicine, 5915 Ponce de Leon Boulevard, 5th Floor, Coral Gables, FL 33146 USA.'}, {'ForeName': 'Luz M', 'Initials': 'LM', 'LastName': 'Prieto-Sanchez', 'Affiliation': 'North Florida Regional Thyroid Center, Tallahassee, Florida.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Roach', 'Affiliation': 'Department of Physical Therapy, University of Miami Miller School of Medicine, 5915 Ponce de Leon Boulevard, 5th Floor, Coral Gables, FL 33146 USA.'}]",Physical therapy,['10.1093/ptj/pzaa008']
1093,29496722,Calcium and vitamin D supplementation and increased risk of serrated polyps: results from a randomised clinical trial.,"OBJECTIVE


Serrated lesions such as sessile serrated adenomas or polyps (SSA/Ps) are important colorectal cancer precursors, but aetiological factors for these lesions are largely unknown. We aimed to determine the effects of calcium and vitamin D supplementation on the incidence of serrated polyps (SPs) in general and hyperplastic polyps and SSA/Ps specifically.
DESIGN


Participants with one or more adenoma at baseline were randomised to receive 1200 mg/day of elemental calcium, 1000 IU/day of vitamin D 3 , both or neither agent. Treatment continued for 3 or 5 years, when risk of polyps was determined from surveillance colonoscopy (treatment phase). Outcomes after treatment ceased were also assessed (observational phase). Adjusted risk ratios (aRRs) of SPs were determined via multivariable generalised linear models.
RESULTS


SPs were diagnosed in 565 of 2058 (27.5%) participants during the treatment phase and 329/1108 (29.7%) during the observational phase. In total, 211 SSA/Ps were identified during follow-up. In the treatment phase, there was no effect of either calcium or vitamin D on incidence of SSA/Ps. However, during the later observational phase, we observed elevated risks of SSA/Ps associated with calcium alone and calcium+vitamin D treatment (aRR (95% CI): 2.65 (1.43 to 4.91) and 3.81 (1.25 to 11.64), respectively).
CONCLUSION


In a large multicentre chemoprevention study, we found evidence that calcium and vitamin D supplementation increased the risk of SSA/Ps. This appeared to be a late effect: 6-10 years after supplementation began. These possible risks must be weighed against the benefits of calcium and vitamin D supplementation. :  Trial registration  NUMBER: NCT00153816; Results.",2019,"Ps associated with calcium alone and calcium+vitamin D treatment (aRR (95% CI): 2.65 (1.43 to 4.91) and 3.81 (1.25 to 11.64), respectively).
","['Participants with one or more adenoma at baseline', 'serrated polyps (SPs) in general and hyperplastic polyps and SSA']","['calcium or vitamin D', 'calcium and vitamin D supplementation', 'Calcium and vitamin D supplementation', 'elemental calcium, 1000 IU/day of vitamin D 3 , both or neither agent']","['risk of serrated polyps', 'risk of SSA/Ps', 'Adjusted risk ratios (aRRs) of SPs']","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C3266123', 'cui_str': 'Serrated polyp (morphologic abnormality)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0333983', 'cui_str': 'Metaplastic polyp (morphologic abnormality)'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3266123', 'cui_str': 'Serrated polyp (morphologic abnormality)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C4255078', 'cui_str': 'SPS'}]",,0.282579,"Ps associated with calcium alone and calcium+vitamin D treatment (aRR (95% CI): 2.65 (1.43 to 4.91) and 3.81 (1.25 to 11.64), respectively).
","[{'ForeName': 'Seth D', 'Initials': 'SD', 'LastName': 'Crockett', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Leila A', 'Initials': 'LA', 'LastName': 'Mott', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Ahnen', 'Affiliation': 'Division of Gastroenterology, University of Colorado School of Medicine, Aurora Health Care, Denver, Colorado, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Robertson', 'Affiliation': 'Division of Gastroenterology and Hepatology, VA Medical Center, White River Junction, VT & Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Anderson', 'Affiliation': 'Division of Gastroenterology and Hepatology, VA Medical Center, White River Junction, VT & Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Wallace', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Burke', 'Affiliation': 'Department of Gastroenterology, Cleveland Clinic School of Medicine, Cleveland, Ohio, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Bresalier', 'Affiliation': 'Department of Gastroenterology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Figueiredo', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Dale C', 'Initials': 'DC', 'LastName': 'Snover', 'Affiliation': 'Department of Pathology, Fairview Southdale Hospital, Edina, Minnesota, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}]",Gut,['10.1136/gutjnl-2017-315242']
1094,29498170,Pharmacogenetics of Dopamine β-Hydroxylase in cocaine dependence therapy with doxazosin.,"The α 1  -adrenergic antagonist, doxazosin, has improved cocaine use disorder (CUD) presumably by blocking norepinephrine (NE) stimulation and reward from cocaine-induced NE increases. If the NE levels for release were lower, then doxazosin might more readily block this NE stimulation and be more effective. The NE available for release can be lower through a genetic polymorphism in dopamine β-hydroxylase (DBH) (C-1021T, rs1611115), which reduces DβH's conversion of dopamine to NE. We hypothesize that doxazosin would be more effective in CUD patients who have these genetically lower DβH levels. This 12-week, double-blind, randomized, placebo-controlled trial included 76 CUD patients: 49 with higher DβH levels from the DBH CC genotype and 27 with lower DβH levels from T-allele carriers (CT or TT). Patients were randomized to doxazosin (8 mg/day, N = 47) or placebo (N = 29) and followed with thrice weekly urine toxicology and once weekly cognitive behavioral psychotherapy. Cocaine use was reduced at a higher rate among patients in the doxazosin than in the placebo arm. We found significantly lower cocaine use rates among patients carrying the T-allele (CT/TT) than the CC genotype. The percentage of cocaine positive urines was reduced by 41 percent from baseline in the CT/TT group with low DβH and NE levels, as compared with no net reduction in the CC genotype group with normal DβH and NE levels. The DBH polymorphism appears play an important role in CUD patients' response to doxazosin treatment, supporting a pharmacogenetic association and potential application for personalized medicine.",2019,We found significantly lower cocaine use rates among patients carrying the T-allele (CT/TT) than the CC genotype.,['76 CUD patients: 49 with higher DβH levels from the DBH CC genotype and 27 with lower DβH levels from T-allele carriers (CT or TT'],"['Cocaine', 'placebo (N\xa0=\xa029) and followed with thrice weekly urine toxicology and once weekly cognitive behavioral psychotherapy', 'placebo', 'doxazosin']",['percentage of cocaine positive urines'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0040541', 'cui_str': 'Toxicology'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0114873', 'cui_str': 'Doxazosin'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0042037'}]",76.0,0.0748345,We found significantly lower cocaine use rates among patients carrying the T-allele (CT/TT) than the CC genotype.,"[{'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Nielsen', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA.'}, {'ForeName': 'Coreen B', 'Initials': 'CB', 'LastName': 'Domingo', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA.'}, {'ForeName': 'Daryl I', 'Initials': 'DI', 'LastName': 'Shorter', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Nielsen', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Kosten', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA.'}]",Addiction biology,['10.1111/adb.12611']
1095,31972630,Effect of High-Intensity Training and Asthma on the V˙O2 Kinetics of Adolescents.,"PURPOSE


High-intensity interval training (HIIT) represents a potent stimulus to the dynamic oxygen uptake (V˙O2) response in adults, but whether the same is evident in youth is unknown. HIIT has also been suggested to place a lower demand on the respiratory system, decreasing the likelihood of exacerbation in those with respiratory conditions, such as asthma.
METHODS


Sixty-nine adolescents (13.6 ± 0.9 yr; 36 asthma) took part, 35 of which (17 asthma) participated in a 30-min HIIT intervention three times a week for 6 months. Each participant completed an incremental ramp test to volitional exhaustion and three heavy-intensity constant work rate tests to determine the dynamic V˙O2, heart rate, and deoxyhemoglobin response at baseline, midintervention, postintervention and at a 3-month follow-up.
RESULTS


There was no influence of asthma at baseline or in response to the intervention. Participants in the intervention group demonstrated a faster V˙O2 time constant (τp) after intervention (intervention: 29.2 ± 5.7 s vs control: 34.2 ± 6.5 s; P = 0.003), with these differences maintained at follow-up (intervention: 32.5 ± 5.5 s vs control: 37.3 ± 8.7 s; P = 0.008). The intervention was associated with a speeding of the concentration of deoxyhemoglobin τ (pre: 20.1 ± 4.7 s vs post: 18.2 ± 4.1 s; P = 0.05) compared with a slowing over the same time period in the control participants (pre: 17.9 ± 4.9 s vs post: 20.1 ± 4.6 s; P = 0.012). Heart rate kinetics were not altered (pre: 46.5 ± 12.2 s vs post: 47.7 ± 11.1 s; P = 0.98).
CONCLUSION


These findings highlight the potential utility of school-based HIIT as a strategy to enhance the V˙O2 kinetics of youth, regardless of the presence of asthma.",2020,"HR kinetics were not altered (Pre: 46.5±12.2 vs. Post: 47.7±11.1 s; P=0.98).
","['Adolescents', 'Sixty-nine adolescents (13.6±0.9 years; 36 asthma) took part, 35 of which (17 asthma']","['High-Intensity Training and Asthma', 'High-intensity interval training (HIIT']","['dynamic oxygen uptake (V[Combining Dot Above]O2), heart rate (HR) and deoxyhaemoglobin ([HHb]) response', 'faster V[Combining Dot Above]O2 time constant', 'HR kinetics']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0057437', 'cui_str': 'T-state hemoglobin'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]",69.0,0.0213114,"HR kinetics were not altered (Pre: 46.5±12.2 vs. Post: 47.7±11.1 s; P=0.98).
","[{'ForeName': 'Melitta A', 'Initials': 'MA', 'LastName': 'McNarry', 'Affiliation': 'Applied Sports Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UNITED KINGDOM.'}, {'ForeName': 'Charles O N', 'Initials': 'CON', 'LastName': 'Winn', 'Affiliation': 'Applied Sports Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UNITED KINGDOM.'}, {'ForeName': 'Gwyneth A', 'Initials': 'GA', 'LastName': 'Davies', 'Affiliation': 'Swansea University Medical School, Singleton Campus, Swansea University, Swansea, UNITED KINGDOM.'}, {'ForeName': 'William T B', 'Initials': 'WTB', 'LastName': 'Eddolls', 'Affiliation': 'Applied Sports Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UNITED KINGDOM.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Mackintosh', 'Affiliation': 'Applied Sports Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UNITED KINGDOM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002270']
1096,31504495,Examining smoke-free coalitions in Armenia and Georgia: baseline community capacity.,"Local coalitions can advance public health initiative but have not been widely used or well-studied in low- and middle-income countries. This paper provides (i) an overview of an ongoing matched-pairs community-randomized controlled trial in 28 communities in Armenia and Georgia (N = 14/country) testing local coalitions to promote smoke-free policies/enforcement and (ii) characteristics of the communities involved. In July-August 2018, key informants (e.g. local public health center directors) were surveyed to compare their non-communicable disease (NCD) and tobacco-related activities across countries and across condition (intervention/control). More than half of the informants (50.0-57.1%) reported their communities had programs addressing hypertension, diabetes, cancer and human papilloma virus, with 85.7% involving community education and 32.1% patient education programs. Eleven communities (39.3%) addressed tobacco control, all of which were in Georgia. Of those, all included public/community education and the majority (72.7-81.8%) provided cessation counseling/classes, school/youth prevention programs, healthcare provider training or activities addressing smoke-free environments. Informants in Georgia versus Armenia perceived greater support for tobacco control from various sectors (e.g. government, community). No differences were found by condition assignment. This paper provides a foundation for presenting subsequent analyses of this ongoing trial. These analyses indicate wide variability regarding NCD-related activities and support across communities and countries.",2019,No differences were found by condition assignment.,['28 communities in Armenia and Georgia'],['healthcare provider training or activities addressing smoke-free environments'],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0003798', 'cui_str': 'Armenian SSR'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}]","[{'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",[],,0.0377896,No differences were found by condition assignment.,"[{'ForeName': 'Carla J', 'Initials': 'CJ', 'LastName': 'Berg', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Dekanosidze', 'Affiliation': 'National Center for Disease Control and Public Health, 4 Kakheti Hwy, Tbilisi, Georgia.'}, {'ForeName': 'Arevik', 'Initials': 'A', 'LastName': 'Torosyan', 'Affiliation': 'National Institute of Health named after academician S. Avdalbekyan, MoH, Komitasi Ave. 49/4, Yerevan, Armenia.'}, {'ForeName': 'Lilit', 'Initials': 'L', 'LastName': 'Grigoryan', 'Affiliation': 'National Institute of Health named after academician S. Avdalbekyan, MoH, Komitasi Ave. 49/4, Yerevan, Armenia.'}, {'ForeName': 'Zhanna', 'Initials': 'Z', 'LastName': 'Sargsyan', 'Affiliation': 'Turpanjian School of Public Health, American University of Armenia, 40 Marshal Baghramyan Ave., Yerevan, Armenia.'}, {'ForeName': 'Varduhi', 'Initials': 'V', 'LastName': 'Hayrumyan', 'Affiliation': 'Turpanjian School of Public Health, American University of Armenia, 40 Marshal Baghramyan Ave., Yerevan, Armenia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Topuridze', 'Affiliation': 'National Center for Disease Control and Public Health, 4 Kakheti Hwy, Tbilisi, Georgia.'}, {'ForeName': 'Lela', 'Initials': 'L', 'LastName': 'Sturua', 'Affiliation': 'National Center for Disease Control and Public Health, 4 Kakheti Hwy, Tbilisi, Georgia.'}, {'ForeName': 'Arusyak', 'Initials': 'A', 'LastName': 'Harutyunyan', 'Affiliation': 'Turpanjian School of Public Health, American University of Armenia, 40 Marshal Baghramyan Ave., Yerevan, Armenia.'}, {'ForeName': 'Lela', 'Initials': 'L', 'LastName': 'Kvachantiradze', 'Affiliation': 'National Center for Disease Control and Public Health, 4 Kakheti Hwy, Tbilisi, Georgia.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Maglakelidze', 'Affiliation': 'National Center for Disease Control and Public Health, 4 Kakheti Hwy, Tbilisi, Georgia.'}, {'ForeName': 'Amiran', 'Initials': 'A', 'LastName': 'Gamkrelidze', 'Affiliation': 'National Center for Disease Control and Public Health, 4 Kakheti Hwy, Tbilisi, Georgia.'}, {'ForeName': 'Romela', 'Initials': 'R', 'LastName': 'Abovyan', 'Affiliation': 'Department of Epidemiology of Noncommunicable and Nosocomial Infectious Disease, National Center for Disease Control and Prevention, MOH RA, Mkhitar Heratsu St. 12, Yerevan, Armenia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bazarchyan', 'Affiliation': 'National Institute of Health named after academician S. Avdalbekyan, MoH, Komitasi Ave. 49/4, Yerevan, Armenia.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Kegler', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, USA.'}]",Health education research,['10.1093/her/cyz024']
1097,31431077,An Automated Text Message Navigation Program Improves the Show Rate for Outpatient Colonoscopy.,"Background . Numerous barriers to outpatient colonoscopy completion exist, causing undue procedure cancellations and poor bowel preparation. We piloted a text message navigation program to improve colonoscopy adherence.  Method.  We conducted a prospective study of patients aged 18 to 75 years scheduled for outpatient colonoscopy at an urban endoscopy center in April 2018. An intervention arm consisting of bidirectional, automated text messages prior to the procedure was compared with a usual care arm. We enrolled 21 intervention patients by phone and randomly selected 50 controls. Outcomes included colonoscopy appointment adherence, bowel preparation quality, and colonoscopy completion.  Results . The arms had similar demographics and comorbidities. Intervention patients had higher colonoscopy appointment adherence (90% vs. 62%,  p =  0.049). There were no significant differences in preparation quality or procedure completeness. Poststudy surveys indicated high patient satisfaction and perceived usefulness of the program.  Conclusion . A bidirectional, automated texting navigation program improved colonoscopy adherence rates as compared with usual care.",2019,"Intervention patients had higher colonoscopy appointment adherence (90% vs. 62%,  p =  0.049).","['patients aged 18 to 75 years scheduled for outpatient colonoscopy at an urban endoscopy center in April 2018', '21 intervention patients by phone and randomly selected 50 controls']",['text message navigation program'],"['preparation quality or procedure completeness', 'colonoscopy adherence rates', 'colonoscopy appointment adherence, bowel preparation quality, and colonoscopy completion', 'colonoscopy appointment adherence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439812', 'cui_str': 'Completeness (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}]",,0.0389662,"Intervention patients had higher colonoscopy appointment adherence (90% vs. 62%,  p =  0.049).","[{'ForeName': 'Nadim', 'Initials': 'N', 'LastName': 'Mahmud', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sahil D', 'Initials': 'SD', 'LastName': 'Doshi', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Coniglio', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Clermont', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Bernard', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reitz', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Khungar', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119869964']
1098,29471100,Dynamic fMRI networks predict success in a behavioral weight loss program among older adults.,"More than one-third of adults in the United States are obese, with a higher prevalence among older adults. Obesity among older adults is a major cause of physical dysfunction, hypertension, diabetes, and coronary heart diseases. Many people who engage in lifestyle weight loss interventions fail to reach targeted goals for weight loss, and most will regain what was lost within 1-2 years following cessation of treatment. This variability in treatment efficacy suggests that there are important phenotypes predictive of success with intentional weight loss that could lead to tailored treatment regimen, an idea that is consistent with the concept of precision-based medicine. Although the identification of biochemical and metabolic phenotypes are one potential direction of research, neurobiological measures may prove useful as substantial behavioral change is necessary to achieve success in a lifestyle intervention. In the present study, we use dynamic brain networks from functional magnetic resonance imaging (fMRI) data to prospectively identify individuals most likely to succeed in a behavioral weight loss intervention. Brain imaging was performed in overweight or obese older adults (age: 65-79 years) who participated in an 18-month lifestyle weight loss intervention. Machine learning and functional brain networks were combined to produce multivariate prediction models. The prediction accuracy exceeded 95%, suggesting that there exists a consistent pattern of connectivity which correctly predicts success with weight loss at the individual level. Connectivity patterns that contributed to the prediction consisted of complex multivariate network components that substantially overlapped with known brain networks that are associated with behavior emergence, self-regulation, body awareness, and the sensory features of food. Future work on independent datasets and diverse populations is needed to corroborate our findings. Additionally, we believe that efforts can begin to examine whether these models have clinical utility in tailoring treatment.",2018,"The prediction accuracy exceeded 95%, suggesting that there exists a consistent pattern of connectivity which correctly predicts success with weight loss at the individual level.","['overweight or obese older adults (age: 65-79 years) who participated in an 18-month lifestyle weight loss intervention', 'older adults']","['Dynamic fMRI networks', 'Brain imaging']",[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain (procedure)'}]",[],,0.0231065,"The prediction accuracy exceeded 95%, suggesting that there exists a consistent pattern of connectivity which correctly predicts success with weight loss at the individual level.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mokhtari', 'Affiliation': 'Laboratory for Complex Brain Networks, Department of Radiology, Wake Forest University School of Medicine, Winston Salem, NC, USA; Virginia Tech-Wake Forest University School of Biomedical Engineering and Sciences, Wake Forest University School of Medicine, Winston Salem, NC, USA.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Laboratory for Complex Brain Networks, Department of Radiology, Wake Forest University School of Medicine, Winston Salem, NC, USA; Translational Science Center, Wake Forest University, Winston Salem, NC, USA; Department of Health and Exercise Science, Wake Forest University, Winston Salem, NC, USA; Department of Geriatric Medicine, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiology and BRIC, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Guorong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of Radiology and BRIC, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sean L', 'Initials': 'SL', 'LastName': 'Simpson', 'Affiliation': 'Laboratory for Complex Brain Networks, Department of Radiology, Wake Forest University School of Medicine, Winston Salem, NC, USA; Virginia Tech-Wake Forest University School of Biomedical Engineering and Sciences, Wake Forest University School of Medicine, Winston Salem, NC, USA; Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston Salem, NC, USA.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Burdette', 'Affiliation': 'Laboratory for Complex Brain Networks, Department of Radiology, Wake Forest University School of Medicine, Winston Salem, NC, USA; Translational Science Center, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Laurienti', 'Affiliation': 'Laboratory for Complex Brain Networks, Department of Radiology, Wake Forest University School of Medicine, Winston Salem, NC, USA; Translational Science Center, Wake Forest University, Winston Salem, NC, USA. Electronic address: plaurien@wakehealth.edu.'}]",NeuroImage,['10.1016/j.neuroimage.2018.02.025']
1099,29471460,Coaching primary care clinics for HPV vaccination quality improvement: Comparing in-person and webinar implementation.,"State health departments commonly use quality improvement coaching as an implementation strategy for improving low human papillomavirus (HPV) vaccination coverage, but such coaching can be resource intensive. To explore opportunities for improving efficiency, we compared in-person and webinar delivery of coaching sessions on implementation outcomes, including reach, acceptability, and delivery cost. In 2015, we randomly assigned 148 high-volume primary care clinics in Illinois, Michigan, and Washington State to receive either in-person or webinar coaching. Coaching sessions lasted about 1 hr and used our Immunization Report Card to facilitate assessment and feedback. Clinics served over 213,000 patients ages 11-17. We used provider surveys and delivery cost assessment to collect implementation data. This report is focused exclusively on the implementation aspects of the intervention. More providers attended in-person than webinar coaching sessions (mean 9 vs. 5 providers per clinic, respectively, p = .004). More providers shared the Immunization Report Card at clinic staff meetings in the in-person than webinar arm (49% vs. 20%; p = .029). In both arms, providers' belief that their clinics' HPV vaccination coverage was too low increased, as did their self-efficacy to help their clinics improve (p < .05). Providers rated coaching sessions in the two arms equally highly on acceptability. Delivery cost per clinic was $733 for in-person coaching versus $461 for webinar coaching. In-person and webinar coaching were well received and yielded improvements in provider beliefs and self-efficacy regarding HPV vaccine quality improvement. In summary, in-person coaching cost more than webinar coaching per clinic reached, but reached more providers. Further implementation research is needed to understand how and for whom webinar coaching may be appropriate.",2019,In-person and webinar coaching were well received and yielded improvements in provider beliefs and self-efficacy regarding HPV vaccine quality improvement.,"['213,000 patients ages 11-17']","['148 high-volume primary care clinics in Illinois, Michigan, and Washington State to receive either in-person or webinar coaching']","['HPV vaccination quality improvement', 'reach, acceptability, and delivery cost', 'Delivery cost per clinic', 'provider beliefs and self-efficacy regarding HPV vaccine quality improvement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]",148.0,0.030294,In-person and webinar coaching were well received and yielded improvements in provider beliefs and self-efficacy regarding HPV vaccine quality improvement.,"[{'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Calo', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Melissa B', 'Initials': 'MB', 'LastName': 'Gilkey', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leeman', 'Affiliation': 'School of Nursing, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Heisler-MacKinnon', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Chrystal', 'Initials': 'C', 'LastName': 'Averette', 'Affiliation': 'Washington State Department of Health, Office of Immunization and Child Profile, Olympia, WA, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sanchez', 'Affiliation': 'Michigan Department of Community Health, Division of Immunization, Lansing, MI, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Kornides', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby008']
1100,31982581,"Sleep, Growth, and Puberty After 2 Years of Prolonged-Release Melatonin in Children With Autism Spectrum Disorder.","OBJECTIVE


A recent 3-month double-blind, placebo-controlled study demonstrated efficacy and safety of pediatric prolonged-release melatonin (PedPRM) for insomnia in children with autism spectrum disorder. This study examined the long-term effects of PedPRM treatment on sleep, growth, body mass index, and pubertal development.
METHOD


Eighty children and adolescents (2-17.5 years of age; 96% with autism spectrum disorder) who completed the double-blind, placebo-controlled trial were given 2 mg, 5 mg, or 10 mg PedPRM nightly up to 104 weeks, followed by a 2-week placebo period to assess withdrawal effects.
RESULTS


Improvements in child sleep disturbance and caregiver satisfaction with child sleep patterns, quality of sleep, and quality of life were maintained throughout the 104-week treatment period (p < .001 versus baseline for all). During the 2-week withdrawal placebo period, measures declined compared with the treatment period but were still improved compared with baseline. PedPRM was generally safe; the most frequent treatment-related adverse events were fatigue (6.3%), somnolence (6.3%), and mood swings (4.2%). Changes in mean weight, height, body mass index, and pubertal status (Tanner staging done by a physician) were within normal ranges for age with no evidence of delay in body mass index or pubertal development.
CONCLUSION


Nightly PedPRM at optimal dose (2, 5, or 10 mg nightly) is safe and effective for long-term treatment in children and adolescents with autism spectrum disorder and insomnia. There were no observed detrimental effects on children's growth and pubertal development and no withdrawal or safety issues related to the use or discontinuation of the drug.
CLINICAL TRIAL REGISTRATION INFORMATION


Efficacy and Safety of Circadin in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities; https://clinicaltrials.gov/; NCT01906866.",2020,There were no observed detrimental effects on children's growth and pubertal development and no withdrawal or safety issues related to the use or discontinuation of the drug.,"['children with autism spectrum disorder (ASD', 'Children With Autism Spectrum Disorder', 'children and adolescents with ASD and insomnia', 'Eighty children and adolescents (96% ASD) ages 2-17.5 years who completed the double-blind']","['PedPRM', 'placebo', 'child-appropriate prolonged-release melatonin (PedPRM']","['withdrawal effects', 'sleep, growth, body mass index, and pubertal development', 'Sleep, Growth, and Puberty', 'safe and effective', ""child sleep disturbance, and caregivers' satisfaction of their child's sleep patterns, quality of sleep and quality of life"", 'mean weight, height, body mass index (BMI) and pubertal status (Tanner staging done by a physician', 'somnolence', ""children's growth and pubertal development and no withdrawal or safety""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0335730', 'cui_str': 'Tanner (occupation)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",80.0,0.196118,There were no observed detrimental effects on children's growth and pubertal development and no withdrawal or safety issues related to the use or discontinuation of the drug.,"[{'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Malow', 'Affiliation': 'Sleep Division, Vanderbilt University Medical Center, Nashville, TN. Electronic address: beth.malow@vumc.org.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': 'Kennedy Krieger Institute/Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Carmen M', 'Initials': 'CM', 'LastName': 'Schroder', 'Affiliation': 'Strasbourg University Hospital, France, and CNRS UPR 3212, Institute of Cellular and Integrative Neurosciences, Strasbourg, France.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Maras', 'Affiliation': 'Yulius Academy, Yulius Mental Health Organization, Dordrecht, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Breddy', 'Affiliation': 'Pharmastat Consulting Ltd, Canterbury, UK.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Nir', 'Affiliation': 'Neurim Pharmaceuticals Ltd, Tel Aviv, Israel.'}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Zisapel', 'Affiliation': 'Neurim Pharmaceuticals Ltd, Tel Aviv, Israel.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gringras', 'Affiliation': ""Children's Sleep Medicine, Evelina London Children's Hospital, Guy's and St Thomas', London, UK.""}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.12.007']
1101,30915431,"Improving diet quality among adolescents, using health belief model in a collaborative learning context: a randomized field trial study.","This study aimed to assess the impact of educational intervention, based on health belief model (HBM) and collaborative learning techniques on diet quality in adolescents. In this field trial study, 311 students aged 13-15 years old were included, of which 163 and 148 allocated in the experimental and comparison groups, respectively. They were selected through a stratified random sampling from 16 urban, secondary schools in 4 educational districts of Shiraz, the largest city in southern Iran. The revised children diet quality index was used to assess their diet quality. Using HBM as a framework for targeting determinants of dietary behavior, the intervention was performed in a collaborative learning context during the educational year (2015-16). Constructs of HBM and diet quality were measured before and after the intervention. All HBM's constructs and knowledge had significantly improved in the experimental group and mean differences were increased after the intervention. Diet quality improved in the experimental group (P < 0.001), which was significantly different from the comparison group (P = 0.001). The findings support the integration of appropriate models/theories into the context of collaborative learning methods to target large number of behavioral determinants, and ultimately increase the effectiveness of the educational interventions amongst adolescents.",2019,All HBM's constructs and knowledge had significantly improved in the experimental group and mean differences were increased after the intervention.,"['311 students aged 13-15 years old were included, of which 163 and 148 allocated in the experimental and comparison groups, respectively', 'adolescents', '16 urban, secondary schools in 4 educational districts of Shiraz, the largest city in southern Iran']","['educational intervention, based on health belief model (HBM) and collaborative learning techniques']","['HBM and diet quality', 'Diet quality']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3714363', 'cui_str': 'Health belief model (qualifier value)'}, {'cui': 'C4505156', 'cui_str': 'Collaborative Learning'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",311.0,0.0342881,All HBM's constructs and knowledge had significantly improved in the experimental group and mean differences were increased after the intervention.,"[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Keshani', 'Affiliation': 'School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hossein Kaveh', 'Affiliation': 'Research Center for Health Sciences. Institute of Health. Shiraz University of Medical Sciences. Shiraz, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Faghih', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Moosa', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Health education research,['10.1093/her/cyz009']
1102,31960175,Experience Versus Report: Where Are Changes Seen After Exposure-Based Cognitive-Behavioral Therapy? A Randomized Controlled Group Treatment of Childhood Social Anxiety Disorder.,"A considerable number of children and adolescents with social anxiety disorder (SAD) do not benefit from treatment as much as expected. However, treatment success should not be measured with social anxiety reports alone; the cognitive, behavioral, and physiological components of social stress should also be assessed. The authors examined an exposure-based SAD-specific group cognitive behavioral therapy (CBT) in a randomized controlled trial (N = 67, age 9-13 years, blind randomized allocation to treatment [CBT; n = 31] and waitlist control [WLC; n = 36] groups). Success was operationalized as a clinically significant reduction of symptoms measured with SAD-specific questionnaires, structured interviews, and changes in response to the Trier Social Stress Test (TSST). In the CBT group, there was a trend toward a significant increase in positive cognitions in the TSST after treatment (d = 0.37), whereas these positive cognitions decreased in the WLC group (d = 0.40). No significant results involving group appeared for negative cognitions, behavior and physiology. Children in the CBT group, but not parents, further reported less social anxiety in one questionnaire from pre- to post-treatment (d = 0.89). A structured interview confirmed a decrease in severity of SAD in the CBT group. While the gold standard of a blind interview showed efficacy of treatment, not all trait and state measures demonstrated similar success patterns.Trial registration Eligibility criteria and some of the dependent variables (cognitions, physiology) for treatment success were registered with the German Research Foundation (TU 78/5-2, HE 3342/4-2) prior to recruitment. Clinical assessment of diagnosis and behavioral data were not a priori planned as outcome measures for this trial and therefore analyzed in a post-hoc approach.",2020,"In the CBT group, there was a trend toward a significant increase in positive cognitions in the TSST after treatment (d = 0.37), whereas these positive cognitions decreased in the WLC group (d = 0.40).","['N\u2009=\u200967, age 9-13\xa0years', 'children and adolescents with social anxiety disorder (SAD', 'Childhood Social Anxiety Disorder']","['WLC', 'exposure-based SAD-specific group cognitive behavioral therapy (CBT', 'CBT', 'waitlist control [WLC', 'TSST']","['severity of SAD', 'SAD-specific questionnaires, structured interviews, and changes in response to the Trier Social Stress Test (TSST', 'negative cognitions, behavior and physiology', 'positive cognitions', 'social anxiety']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0270305', 'cui_str': 'Avoidant disorder of childhood (disorder)'}]","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}]",,0.0322738,"In the CBT group, there was a trend toward a significant increase in positive cognitions in the TSST after treatment (d = 0.37), whereas these positive cognitions decreased in the WLC group (d = 0.40).","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Asbrand', 'Affiliation': 'Department of Psychology, University of Freiburg, Freiburg im Breisgau, Germany. julia.asbrand@psychologie.uni-freiburg.de.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, University of Bremen, Bremen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schmidtendorf', 'Affiliation': 'Department of Psychology, University of Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Nitschke', 'Affiliation': 'Department of Psychology, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Brunna', 'Initials': 'B', 'LastName': 'Tuschen-Caffier', 'Affiliation': 'Department of Psychology, University of Freiburg, Freiburg im Breisgau, Germany.'}]",Child psychiatry and human development,['10.1007/s10578-019-00954-w']
1103,31923471,"Memory advancement by intranasal insulin in type 2 diabetes (MemAID) randomized controlled clinical trial: Design, methods and rationale.","BACKGROUND


Type 2 diabetes mellitus (T2DM) accelerates brain aging and increases the risk for dementia. Insulin is a key neurotrophic factor in the brain, where it modulates energy metabolism, neurovascular coupling, and regeneration. Impaired insulin-mediated brain signaling and central insulin resistance may contribute to cognitive and functional decline in T2DM. Intranasal insulin (INI) has emerged as a potential therapy for treating T2DM-related cognitive impairment.
METHODS/DESIGN


Ongoing from 2015, a prospective, two-center, randomized, double-blind, placebo-controlled trial of 210 subjects (120 T2DM and 90 non-diabetic older adults) randomized into four treatment arms (60 T2DM-INI, 60 T2DM-Placebo, 45 Control-INI, and 45 Control-Placebo) evaluating the long-term effects of daily intranasal administration of 40 International Units (IU) of human insulin, as compared to placebo (sterile saline) over 24 weeks and 24 weeks of post-treatment follow-up. Study outcomes are: 1) long-term INI effects on cognition, daily functionality, and gait speed; 2) identifying a clinically relevant phenotype that predicts response to INI therapy; 3) long-term safety.
CONCLUSION


This study addresses an important knowledge gap about the long-term effects of intranasal insulin on memory and cognition in older people with T2DM and non-diabetic controls, and may provide a novel therapeutic target for prevention and treatment of cognitive and functional decline and dementia. Trial Registration NCT02415556.",2020,"This study addresses an important knowledge gap about the long-term effects of intranasal insulin on memory and cognition in older people with T2DM and non-diabetic controls, and may provide a novel therapeutic target for prevention and treatment of cognitive and functional decline and dementia.","['type 2 diabetes (MemAID', 'older people with T2DM and non-diabetic controls', '210 subjects (120 T2DM and 90 non-diabetic older adults']","['daily intranasal administration of 40 International Units (IU) of human insulin, as compared to placebo (sterile saline', 'intranasal insulin', 'placebo', 'Memory advancement by intranasal insulin', 'T2DM-Placebo, 45 Control-INI, and 45 Control-Placebo', 'Intranasal insulin (INI']","['memory and cognition', '1) long-term INI effects on cognition, daily functionality, and gait speed; 2) identifying a clinically relevant phenotype that predicts response to INI therapy; 3) long-term safety']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0001560', 'cui_str': 'Drug Administration, Intranasal'}, {'cui': 'C0439453', 'cui_str': 'IU'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",210.0,0.477211,"This study addresses an important knowledge gap about the long-term effects of intranasal insulin on memory and cognition in older people with T2DM and non-diabetic controls, and may provide a novel therapeutic target for prevention and treatment of cognitive and functional decline and dementia.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Galindo-Mendez', 'Affiliation': 'Department of Neurology, SAFE Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Trevino', 'Affiliation': 'Department of Neurology, SAFE Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McGlinchey', 'Affiliation': 'Translational Research Center for TBI and Stress Disorders (TRACTS), Geriatric Research Education and Clinical Center (GRECC), VA Boston Healthcare System, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fortier', 'Affiliation': 'Translational Research Center for TBI and Stress Disorders (TRACTS), Geriatric Research Education and Clinical Center (GRECC), VA Boston Healthcare System, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lioutas', 'Affiliation': 'Department of Neurology, SAFE Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': ""Autonomic Laboratory, Department of Neurology, Brigham and Women's Faulkner Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston MA; Department of Medicine, Boston VA Healthcare System, Harvard Medical School, Boston, MA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ngo', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Novak', 'Affiliation': 'Department of Neurology, SAFE Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. Electronic address: vnovak@bidmc.harvard.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105934']
1104,31954066,Probiotics for recurrent idiopathic aphthous stomatitis in adults: a placebo-controlled randomized trial.,,2020,"Sir, recurrent idiopathic aphtosous stomatitis (RIAS) is a frequent disorder that induces a marked alteration of the quality of life of affected individuals.",['recurrent idiopathic aphthous stomatitis in adults'],"['placebo', 'Thalidomide', 'thalidomide', 'Probiotics']",[],"[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0038363', 'cui_str': 'Ulcer, Aphthous'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]",[],,0.0574893,"Sir, recurrent idiopathic aphtosous stomatitis (RIAS) is a frequent disorder that induces a marked alteration of the quality of life of affected individuals.","[{'ForeName': 'P-M', 'Initials': 'PM', 'LastName': 'Dugourd', 'Affiliation': ""Service de Dermatologie, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': ""Service de Dermatologie, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fontas', 'Affiliation': ""Centre Hospitalier Universitaire Nice, Délégation à la Recherche Clinique et à l'Innovation, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Velin', 'Affiliation': ""Service de Dermatologie, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Montaudié', 'Affiliation': ""Service de Dermatologie, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': ""Service de Dermatologie, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Passeron', 'Affiliation': ""Service de Dermatologie, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16199']
1105,31944878,"A Comparative Assessment of the Efficiency of Orthodontic Treatment With and Without Photobiomodulation During Mandibular Decrowding in Young Subjects: A Single-Center, Single-Blind Randomized Controlled Trial.","Objective:  To assess if photobiomodulation (PBM) improves the efficiency of orthodontic treatment with fixed appliance during the alignment stage.  Methods:  Eighty-nine subjects were included in this trial and randomly assigned for treatment with fixed appliance and PBM group or with fixed appliance only (control group). Inclusion criteria were as follows: (1) age between 13 and 30 years, (2) permanent dentition, (3) class I malocclusion, (4) lower 6-6 mild crowding measured on dental cast, (5) no spaces or diastema in the lower arch, (6) no ectopic teeth, (7) nonextractive treatment plan, and (8) no previous orthodontic treatment. PBM was administered in the PBM group every 14 days using the ATP38 ®  (Biotech Dental, Allée de Craponne, Salon de Provence, France) (72 J/cm 2  of fluency for each session). Dental alignment was assessed by visual inspection, and treatment time was defined in days as T2 (date of assessment of complete dental alignment)-T1 (date of brackets bonding). The number of monthly scheduled appointments was also recorded. All the data underwent statistical analysis for comparison between groups.  Results:  Treatment time was significantly shorter ( p  < 0.001) in the PBM group (203 days) compared with the control (260 days). Consequently, control visits ( p  < 0.001) were lower in the PBM group (7) compared with the control group (9).  Conclusions:  The present findings would confirm that PBM can be used to enhance the efficiency of orthodontic treatment during dental decrowding.",2020,Treatment time was significantly shorter ( p  < 0.001) in the PBM group (203 days) compared with the control (260 days).,"['1) age between 13 and 30 years, (2) permanent dentition, (3) class', 'Methods:  Eighty-nine subjects', 'Young Subjects']","['fixed appliance and PBM group or with fixed appliance only (control group', 'PBM', 'photobiomodulation (PBM', 'Orthodontic Treatment With and Without Photobiomodulation']","['number of monthly scheduled appointments', 'Treatment time']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0348070', 'cui_str': 'Dentition, Adult'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",89.0,0.0846448,Treatment time was significantly shorter ( p  < 0.001) in the PBM group (203 days) compared with the control (260 days).,"[{'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Lo Giudice', 'Affiliation': 'Section of Orthodontics, Department of Medical-Surgical Specialties, School of Dentistry, University of Catania, Policlinico Universitario ""V. Emanuele,"" Catania, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Nucera', 'Affiliation': 'Section of Orthodontics, Department of Biomedical and Dental Sciences and Morphofunctional Imaging, School of Dentistry, University of Messina, Policlinico Universitario ""G. Martino,"" Messina, Italy.'}, {'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Leonardi', 'Affiliation': 'Section of Orthodontics, Department of Medical-Surgical Specialties, School of Dentistry, University of Catania, Policlinico Universitario ""V. Emanuele,"" Catania, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Paiusco', 'Affiliation': 'Section of Orthodontics, Department of Surgery and Interdisciplinary Medicine, School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Baldoni', 'Affiliation': 'Section of Orthodontics, Department of Surgery and Interdisciplinary Medicine, School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Caccianiga', 'Affiliation': 'Section of Orthodontics, Department of Surgery and Interdisciplinary Medicine, School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4747']
1106,31633254,Effects of ketamine and midazolam on resting state connectivity and comparison with ENIGMA connectivity deficit patterns in schizophrenia.,"Subanesthetic administration of ketamine is a pharmacological model to elicit positive and negative symptoms of psychosis in healthy volunteers. We used resting-state pharmacological functional MRI (rsPhfMRI) to identify cerebral networks affected by ketamine and compared them to the functional connectivity (FC) in schizophrenia. Ketamine can produce sedation and we contrasted its effects with the effects of the anxiolytic drug midazolam. Thirty healthy male volunteers (age = 19-37 years) underwent a randomized, three-way, cross-over study consisting of three imaging sessions, with 48 hr between sessions. A session consisted of a control period followed by infusion of placebo or ketamine or midazolam. The ENIGMA rsfMRI pipeline was used to derive two long-distance (seed-based and dual-regression) and one local (regional homogeneity, ReHo) FC measures. Ketamine induced significant reductions in the connectivity of the salience network (Cohen's d: 1.13 ± 0.28, p = 4.0 × 10 -3  ), auditory network (d: 0.67 ± 0.26, p = .04) and default mode network (DMN, d: 0.63 ± 0.26, p = .05). Midazolam significantly reduced connectivity in the DMN (d: 0.77 ± 0.27, p = .03). The effect sizes for ketamine for resting networks showed a positive correlation (r = .59, p = .07) with the effect sizes for schizophrenia-related deficits derived from ENIGMA's study of 261 patients and 327 controls. Effect sizes for midazolam were not correlated with the schizophrenia pattern (r = -.17, p = .65). The subtraction of ketamine and midazolam patterns showed a significant positive correlation with the pattern of schizophrenia deficits (r = .68, p = .03). RsPhfMRI reliably detected the shared and divergent pharmacological actions of ketamine and midazolam on cerebral networks. The pattern of disconnectivity produced by ketamine was positively correlated with the pattern of connectivity deficits observed in schizophrenia, suggesting a brain functional basis for previously poorly understood effects of the drug.",2020,"Midazolam significantly reduced connectivity in the DMN (d: 0.77 ± 0.27, p = .03).","['261 patients and 327 controls', 'Thirty healthy male volunteers (age = 19-37\u2009years', 'schizophrenia', 'healthy volunteers']","['midazolam', 'Midazolam', 'Ketamine', 'ketamine', 'placebo or ketamine or midazolam', 'ketamine and midazolam', 'resting-state pharmacological functional MRI (rsPhfMRI']","['schizophrenia pattern', 'auditory network', 'schizophrenia deficits', 'connectivity of the salience network', 'cerebral networks']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]",30.0,0.077698,"Midazolam significantly reduced connectivity in the DMN (d: 0.77 ± 0.27, p = .03).","[{'ForeName': 'Bhim M', 'Initials': 'BM', 'LastName': 'Adhikari', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Dukart', 'Affiliation': 'F. Hoffmann-La Roche, Pharma Research Early Development, Roche Innovation Centre Basel, Basel, Switzerland.'}, {'ForeName': 'Joerg F', 'Initials': 'JF', 'LastName': 'Hipp', 'Affiliation': 'F. Hoffmann-La Roche, Pharma Research Early Development, Roche Innovation Centre Basel, Basel, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forsyth', 'Affiliation': 'School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McMillan', 'Affiliation': 'School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Suresh D', 'Initials': 'SD', 'LastName': 'Muthukumaraswamy', 'Affiliation': 'School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Meghann C', 'Initials': 'MC', 'LastName': 'Ryan', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'L Elliot', 'Initials': 'LE', 'LastName': 'Hong', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Eickhoff', 'Affiliation': 'Institute of Neuroscience and Medicine, Brain & Behaviour (INM-7), Research Centre Jülich, Jülich, Germany.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Jahandshad', 'Affiliation': 'Imaging Genetics Center, Mark & Mary Stevens Neuroimaging & Informatics Institute, Keck School of Medicine, University of Southern California, Marina del Rey, California.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Thompson', 'Affiliation': 'Imaging Genetics Center, Mark & Mary Stevens Neuroimaging & Informatics Institute, Keck School of Medicine, University of Southern California, Marina del Rey, California.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Rowland', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kochunov', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}]",Human brain mapping,['10.1002/hbm.24838']
1107,31899371,Study protocol for a sequential multiple assignment randomized trial (SMART) to improve physical activity in employed women.,"INTRODUCTION


Physical activity monitors, motivational text messages, personal calls, and group meetings, have proven to be efficacious physical activity interventions. However, individual participant response to these interventions varies drastically. A SMART design (sequential multiple assignment randomized trial) provides an effective way to test interventions that start with an initial treatment and then transition to an augmented treatment for non-responders. We describe a SMART to determine the most effective adaptive intervention to increase physical activity (steps, moderate-to-vigorous physical activity) and improve cardiovascular health among employed women who are not regularly physically active. The SMART uses combinations of four treatments: 1) enhanced physical activity monitor (Fitbit wearable activity monitor and mobile app with goal setting and physical activity prescription), 2) text messages, 3) personal calls, and 4) group meetings.
METHODS


Participants (N = 312) include women ages 18-70 employed at a large academic medical center. Women will be randomized to an initial intervention, either an enhanced physical activity monitor or enhanced physical activity monitor + text messaging. Non-responders to the initial intervention at 2 months will be randomized to either personal calls or groups meetings for the next 6 months. At 8 months, all participants will return to only an enhanced physical activity monitor until their final 12-month assessment.
DISCUSSION


Results of this study will add to the literature on improving physical activity in employed women. This study will identify effective interventions for women who respond to less intensive treatments, while maximizing benefits for those who need a more intensive approach.",2020,A SMART design (sequential multiple assignment randomized trial) provides an effective way to test interventions that start with an initial treatment and then transition to an augmented treatment for non-responders.,"['women who respond to less intensive treatments', 'employed women who are not regularly physically active', 'employed women', 'Participants (N\u202f=\u202f312) include women ages 18-70 employed at a large academic medical center']","['enhanced physical activity monitor or enhanced physical activity monitor\u202f+\u202ftext messaging. Non-responders to the initial intervention', 'enhanced physical activity monitor (Fitbit wearable activity monitor and mobile app with goal setting and physical activity prescription), 2) text messages, 3) personal calls, and 4) group meetings']","['cardiovascular health', 'physical activity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",70.0,0.0342475,A SMART design (sequential multiple assignment randomized trial) provides an effective way to test interventions that start with an initial treatment and then transition to an augmented treatment for non-responders.,"[{'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Buchholz', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America. Electronic address: susan_buchholz@rush.edu.'}, {'ForeName': 'JoEllen', 'Initials': 'J', 'LastName': 'Wilbur', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Halloway', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schoeny', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': 'Rush University, College of Health Sciences, Chicago, IL, United States of America.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Vispute', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Kitsiou', 'Affiliation': 'University of Illinois at Chicago, College of Applied Health Sciences, Chicago, IL, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105921']
1108,31923017,Lavage With Lidocaine and Adrenaline Mixture Reduces the Early Side Effects of Septorhinoplasty.,"BACKGROUND


Pain, ecchymosis, and edema are well-known temporary consequences of septorhinoplasty procedure. They give rise to patient's complaints, discomfort, and dissatisfaction, increasing the patient's anxiety and recovery time in the early postoperative course. Several approaches have been described to reduce the level of these complaints.The aim of this clinical study was to determine the effect of nasal lavage with lidocaine and adrenaline mixture on early postoperative levels of pain, edema, and ecchymosis in 24 hours after a septorhinoplasty procedure.
METHODS


This study included 40 consecutive patients who underwent septorhinoplasty procedure in which nasal septum was entirely dissected and corrected. Patients were randomly divided into 2 groups of 20 patients. At the end of the operation, incisions were closed with sutures, and both blood and seroma collections beneath the flaps were sufficiently drained by means of finger pressure, and then in patients of group A (control group), 5 mL of saline solution was given under the dorsal nasal flap to make lavage and in patients of group B (study group), 5 mL of 2% lidocaine with 1:100,000 adrenaline was given to the area under the dorsal nasal flaps. Five minutes later, nasal package and splint were applied and the operation was finished.Patients were evaluated for the level of pain sensation, degree of periorbital edema, and ecchymosis at the 1st, 3rd, 6th, 12th, and 24th hours postoperatively. Overall satisfaction scores were also determined at the 24th hour.
RESULTS


A total of 40 patients (19 males and 21 females) between 18 and 42 years of age with a mean ± standard deviation of 24.5 ± 4.52 years were included in the study. Statistically significant differences were found between the A and B groups with regard to early postoperative pain, edema, ecchymosis, analgesic use, and satisfaction scores, suggesting the effectivity of the lavage with lidocaine-adrenaline mixture on the early postoperative pain, edema, and ecchymosis relief.
CONCLUSIONS


Lavage of nasal flaps with lidocaine-adrenaline mixture seems an effective and simple way in the control of early postoperative pain, edema, and ecchymosis in septorhinoplasty patients. In addition, it considerably reduces total analgesic consumption and patients' discomfort, leading to high level of satisfaction.",2020,"Statistically significant differences were found between the A and B groups with regard to early postoperative pain, edema, ecchymosis, analgesic use, and satisfaction scores, suggesting the effectivity of the lavage with lidocaine-adrenaline mixture on the early postoperative pain, edema, and ecchymosis relief.
","['40 consecutive patients who underwent septorhinoplasty procedure in which nasal septum was entirely dissected and corrected', '24 hours after a septorhinoplasty procedure', 'septorhinoplasty patients', '40 patients (19 males and 21 females) between 18 and 42 years of age with a mean ± standard deviation of 24.5 ± 4.52 years were included in the study']","['saline solution was given under the dorsal nasal flap to make lavage', 'lidocaine with 1:100,000 adrenaline', 'lidocaine and adrenaline mixture', 'lidocaine-adrenaline mixture', 'Lidocaine and Adrenaline']","['Overall satisfaction scores', 'early postoperative pain, edema, and ecchymosis relief', 'early postoperative levels of pain, edema, and ecchymosis', 'early postoperative pain, edema, ecchymosis, analgesic use, and satisfaction scores', 'total analgesic consumption', 'level of pain sensation, degree of periorbital edema, and ecchymosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0189054', 'cui_str': 'Rhinoseptoplasty (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0027432', 'cui_str': 'Nasal Septum'}, {'cui': 'C0205239', 'cui_str': 'Dissecting (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0440841', 'cui_str': 'Nasal flap (substance)'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0151205', 'cui_str': 'Periorbital edema (disorder)'}]",40.0,0.0242988,"Statistically significant differences were found between the A and B groups with regard to early postoperative pain, edema, ecchymosis, analgesic use, and satisfaction scores, suggesting the effectivity of the lavage with lidocaine-adrenaline mixture on the early postoperative pain, edema, and ecchymosis relief.
","[{'ForeName': 'Nazım', 'Initials': 'N', 'LastName': 'Gümüş', 'Affiliation': 'From the Plastic, Reconstructive and Aesthetic Surgery, Department of Mersin University Medical Faculty, Mersin, Turkey.'}]",Annals of plastic surgery,['10.1097/SAP.0000000000002219']
1109,31917607,Pitolisant for Daytime Sleepiness in Patients with Obstructive Sleep Apnea Who Refuse Continuous Positive Airway Pressure Treatment. A Randomized Trial.,"Rationale:  Excessive daytime sleepiness is a common disabling symptom in obstructive sleep apnea syndrome. Objectives:  To evaluate the efficacy and safety of pitolisant, a selective histamine H3 receptor antagonist with wake-promoting effects, for the treatment of daytime sleepiness in patients with moderate to severe obstructive sleep apnea refusing continuous positive airway pressure treatment. Methods:  In an international, multicenter, double-blind, randomized (3:1), placebo-controlled, parallel-design trial, pitolisant was individually titrated at up to 20 mg/d over 12 weeks. The primary endpoint was the change in the Epworth Sleepiness Scale score. Key secondary endpoints were maintenance of wakefulness assessed on the basis of the Oxford Sleep Resistance test, safety, Clinical Global Impression of severity, patient's global opinion, EuroQol quality-of-life questionnaire, and Pichot fatigue questionnaire. Measurements and Main Results:  A total of 268 patients with obstructive sleep apnea (75% male; mean age, 52 yr; apnea-hypopnea index, 49/h; baseline sleepiness score, 15.7) were randomized (200 to pitolisant and 68 to placebo) and analyzed on an intention-to-treat basis. The Epworth Sleepiness Scale score was reduced more with pitolisant than with placebo (-2.8; 95% confidence interval, -4.0 to -1.5;  P  < 0.001). Wake maintenance tests were not improved. The Pichot fatigue score was reduced with pitolisant. The overall impact of pitolisant was confirmed by both physicians' and patients' questionnaires. Adverse event incidence, mainly headache, insomnia, nausea, and vertigo, was similar in the pitolisant and placebo groups (29.5% and 25.4%, respectively), with no cardiovascular or other significant safety concerns. Conclusions:  Pitolisant significantly reduced self-reported daytime sleepiness and fatigue and improved patient-reported outcomes and physician disease severity assessment in sleepy patients with obstructive sleep apnea refusing or nonadherent to continuous positive airway pressure.Clinical trial registered with www.clinicaltrials.gov (NCT01072968) and EU Clinical Trials Register (EudraCT 2009-017251-94).",2020,"Adverse event incidence, mainly headache, insomnia, nausea, and vertigo, was similar in the pitolisant and placebo groups (29.5% and 25.4%, respectively), with no cardiovascular or other significant safety concerns.
","['268 obstructive sleep apnea patients (75% male; mean age: 52 years, Apnea-hypopnea index: 49/hour, baseline sleepiness score: 15.7) were randomized (200 pitolisant; 68', 'obstructive sleep apnea syndrome', 'Obstructive Sleep Apnea Patients Refusing CPAP', 'sleepy patients with obstructive sleep apnea refusing or non-adherent to continuous positive airway pressure', 'patients with moderate to severe obstructive sleep apnea refusing continuous positive airway pressure treatment']",['placebo'],"['Epworth Sleepiness score', 'Adverse event incidence, mainly headache, insomnia, nausea, and vertigo', 'Daytime Sleepiness', 'self-reported daytime sleepiness, fatigue', 'daytime sleepiness', ""maintenance of wakefulness assessed by the Oxford Sleep Resistance Test, safety, clinical global impressions of severity, patient's global opinion, EQ-5D quality-of-life, and Pichot Fatigue questionnaire scores"", 'Pichot fatigue score', 'change in the Epworth Sleepiness score']","[{'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3529928', 'cui_str': 'Pitolisant (substance)'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",268.0,0.277263,"Adverse event incidence, mainly headache, insomnia, nausea, and vertigo, was similar in the pitolisant and placebo groups (29.5% and 25.4%, respectively), with no cardiovascular or other significant safety concerns.
","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'National Reference Center for Narcolepsy, Sleep and Wake Unit, Department of Neurology, Gui-de-Chauliac Hospital, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Verbraecken', 'Affiliation': 'Multidisciplinary Sleep Disorders Center, Antwerp University Hospital and University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Partinen', 'Affiliation': 'Helsinki Sleep Clinic, Vitalmed Research Center, Helsinki, Finland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hedner', 'Affiliation': 'Sleep and Vigilance Laboratory, Department of Internal Medicine, University of Göteborg, Sahlgrenska University Hospital, University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Saaresranta', 'Affiliation': 'Sleep Research Center, Department of Pulmonary Diseases and Clinical Allergology, University of Turku, Turku, Finland.'}, {'ForeName': 'Ognian', 'Initials': 'O', 'LastName': 'Georgiev', 'Affiliation': 'Pulmonology Unit, Department of Internal Medicine, Alexandrovska Hospital Medical University, Sofia, Bulgaria.'}, {'ForeName': 'Rumen', 'Initials': 'R', 'LastName': 'Tiholov', 'Affiliation': 'Department of Internal Diseases, Sveti Ivan Rilski Multiprofile Hospital for Active Treatment, Kozloduy, Bulgaria.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Lecomte', 'Affiliation': 'Bioprojet, 30 rue Francs Bourgois, Paris, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Tamisier', 'Affiliation': 'Hypoxia-Physiopathology (HP2) Laboratory, INSERM U1042, University Grenoble Alpes, Grenoble, France; and.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lévy', 'Affiliation': 'Hypoxia-Physiopathology (HP2) Laboratory, INSERM U1042, University Grenoble Alpes, Grenoble, France; and.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Scart-Gres', 'Affiliation': 'Bioprojet, 30 rue Francs Bourgois, Paris, France.'}, {'ForeName': 'Jeanne-Marie', 'Initials': 'JM', 'LastName': 'Lecomte', 'Affiliation': 'Bioprojet, 30 rue Francs Bourgois, Paris, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Schwartz', 'Affiliation': 'Bioprojet, 30 rue Francs Bourgois, Paris, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pépin', 'Affiliation': 'Hypoxia-Physiopathology (HP2) Laboratory, INSERM U1042, University Grenoble Alpes, Grenoble, France; and.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201907-1284OC']
1110,31959014,Low- Versus Moderate-Sodium Diet in Patients With Recent Hospitalization for Heart Failure: The PROHIBIT (Prevent Adverse Outcomes in Heart Failure by Limiting Sodium) Pilot Study.,"BACKGROUND


We conducted a pilot study to assess feasibility, on-study retention, trends in natriuretic peptide levels, quality of life, and safety of a 12-week feeding trial with 1500- versus 3000-mg daily sodium meals in high-risk patients with heart failure.
METHODS


Of 196 patients with recent (≤2 weeks) hospitalization for heart failure, ejection fraction ≤40%, on optimal medical therapy, functionally independent, and able to communicate, 83 (47%) consented to participate. Of these, 27 (age, 62±11 years; 22 men; 20 white; ejection fraction, 26±8%) had 24-hour urine sodium ≥3000 mg and agreed to randomly receive either 1500-mg (N=12) or 3000-mg (N=15) sodium meals.
RESULTS


On-study retention at 12 weeks was 77% (82% versus 73%;  P =0.53); 6 patients (2 in 1500-mg, 4 in 3000-mg arm) withdrew before study completion. Food satisfaction questionnaires indicated that both diets were well tolerated. Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm. Average compliance with meals was 52% (based on urinary sodium) and was not significantly different between arms (42% versus 60%;  P =0.25). Study meals reduced 24-hour urinary sodium by 137±21 mmol (1500-mg arm) and 82±16 mmol (3000-mg arm), both  P <0.001; between-arms difference was 55 mmol (95% CI, 3-107;  P =0.037). NT-proBNP (N-terminal pro-B-type natriuretic peptide) was not affected. Hospitalizations and low blood pressure events did not differ significantly between arms. Serum creatinine decreased more (by 0.17 mg/dL [95% CI, 0.06-0.28];  P =0.003) in the 1500-mg arm. Creatinine increases >0.5 mg/dL over baseline only occurred in 1 patient in the 3000-mg arm.
CONCLUSIONS


Even with prepared meals, investigating optimal dietary sodium in heart failure comes with challenges, including need for extensive screening, reluctance to participate, and compliance issues. Because both diets reduced urinary sodium without adverse safety or quality of life signals, a larger trial, with modifications to improve participation and compliance, would be ethical and feasible.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02467296.",2020,Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm.,"['Of 196 patients with recent (≤2 weeks) hospitalization for heart failure, ejection fraction ≤40%, on optimal medical therapy, functionally independent, and able to communicate, 83 (47%) consented to participate', 'Patients', '27 (age, 62±11 years; 22 men; 20 white; ejection fraction, 26±8%) had 24-hour urine sodium ≥3000 mg and agreed to randomly receive either 1500-mg (N=12) or 3000-mg (N=15', 'high-risk patients with heart failure']","['Low', '1500- versus 3000-mg daily sodium meals', 'sodium meals', 'NT-proBNP', 'Moderate-Sodium Diet']","['Average compliance with meals', 'Serum creatinine', 'natriuretic peptide levels, quality of life, and safety', 'Creatinine', 'tolerated', 'Quality of life', '24-hour urinary sodium', 'Food satisfaction questionnaires', 'Hospitalizations and low blood pressure events']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C4273559', 'cui_str': 'Functionally independent'}, {'cui': 'C2364293', 'cui_str': 'Able to communicate (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1256585', 'cui_str': 'Sodium measurement, urine (procedure)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0301592', 'cui_str': 'Sodium diet (finding)'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",196.0,0.0541266,Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kalogeropoulos', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, NY (A.K., L.P., H.S.).'}, {'ForeName': 'Lampros', 'Initials': 'L', 'LastName': 'Papadimitriou', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, NY (A.K., L.P., H.S.).'}, {'ForeName': 'Vasiliki V', 'Initials': 'VV', 'LastName': 'Georgiopoulou', 'Affiliation': 'Department of Medicine (V.V.G.), Emory University, Atlanta, GA.'}, {'ForeName': 'Sandra B', 'Initials': 'SB', 'LastName': 'Dunbar', 'Affiliation': 'School of Nursing (S.B.D.), Emory University, Atlanta, GA.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Skopicki', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, NY (A.K., L.P., H.S.).'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson (L.P., J.B.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006389']
1111,31957934,Hydrotherapy following breast cancer surgery Phase II trial on hydrotherapy in women following breast cancer surgery.,,2020,,['women following breast cancer surgery'],"['Hydrotherapy', 'hydrotherapy']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",[],,0.0380531,,"[{'ForeName': 'Rosana Barbosa Alves', 'Initials': 'RBA', 'LastName': 'Siqueira', 'Affiliation': 'Program of Mastology, Federal University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Ruffo', 'Initials': 'R', 'LastName': 'Freitas-Junior', 'Affiliation': 'Program of Mastology, Federal University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Priscila Souza', 'Initials': 'PS', 'LastName': 'Lopes', 'Affiliation': 'Pontifical Catholic University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Marimília Silva', 'Initials': 'MS', 'LastName': 'Lagares', 'Affiliation': 'Pontifical Catholic University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Fabiana Pavan', 'Initials': 'FP', 'LastName': 'Viana', 'Affiliation': 'Pontifical Catholic University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Thamara Marcia Jesus Castro', 'Initials': 'TMJC', 'LastName': 'Mesquita', 'Affiliation': 'Pontifical Catholic University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Leonardo Ribeiro', 'Initials': 'LR', 'LastName': 'Soares', 'Affiliation': 'Program of Mastology, Federal University of Goiás, Goiânia, Brazil.'}]",The breast journal,['10.1111/tbj.13744']
1112,31881392,Cenicriviroc for the treatment of liver fibrosis in adults with nonalcoholic steatohepatitis: AURORA Phase 3 study design.,"INTRODUCTION


Nonalcoholic steatohepatitis (NASH) is a sub-classification of nonalcoholic fatty liver disease (NAFLD) characterized by increased risk of progressive liver fibrosis. Cenicriviroc (CVC) is a novel, orally administered, potent chemokine 2 and 5 receptor antagonist currently in development for the treatment of liver fibrosis in adults with NASH.
METHODS AND ANALYSIS


Efficacy and safety of CVC will be comprehensively evaluated in a global, Phase 3, multicenter, randomized, double-blind, placebo-controlled study (AURORA, NCT03028740) of subjects with NASH and Stage F2 or F3 fibrosis. Approximately 2000 adults (Part 1, 1200 subjects; Part 2, 800 additional subjects) aged 18-75 years with histological evidence of NASH with Stage F2 or F3 fibrosis (NASH Clinical Research Network classification system) will be randomized 2:1 to CVC 150 mg or placebo orally once daily. Primary efficacy endpoints will include the proportion of subjects with ≥1-stage improvement in liver fibrosis and no worsening of steatohepatitis at Month 12 relative to screening (Part 1), and time to first occurrence of any adjudicated event: death; histopathologic progression to cirrhosis; liver transplant; Model of End-Stage Liver Disease score ≥ 15; ascites; hospitalization due to liver decompensation (Part 2). Patient-reported outcomes will assess changes in health outcomes from baseline (Chronic Liver Disease Questionnaire - NAFLD; Work Productivity and Activity Impairment in NASH; 36-Item Short Form Health Survey version 2). Adverse events will be assessed throughout the study. As there are currently no approved treatments indicated for NASH, the AURORA CVC Phase 3 study addresses an unmet medical need.",2020,"Cenicriviroc (CVC) is a novel, orally administered, potent chemokine 2 and 5 receptor antagonist currently in development for the treatment of liver fibrosis in adults with NASH.
","['subjects with NASH and Stage F2 or F3 fibrosis', 'Approximately 2000 adults (Part 1, 1200 subjects; Part 2, 800 additional subjects) aged 18-75\u202fyears with histological evidence of NASH with Stage F2 or F3 fibrosis (NASH Clinical Research Network classification system', 'liver fibrosis in adults with NASH', 'adults with nonalcoholic steatohepatitis']","['CVC', 'CVC 150\u202fmg or placebo', 'Nonalcoholic steatohepatitis (NASH', 'placebo', 'Cenicriviroc (CVC']","['Adverse events', 'proportion of subjects with ≥1-stage improvement in liver fibrosis and no worsening of steatohepatitis at Month 12 relative to screening (Part 1), and time to first occurrence of any adjudicated event: death; histopathologic progression to cirrhosis; liver transplant; Model of End-Stage Liver Disease score\u202f≥\u202f15; ascites; hospitalization due to liver decompensation (Part 2', 'health outcomes from baseline (Chronic Liver Disease Questionnaire - NAFLD; Work Productivity and Activity Impairment']","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}]","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C4279622'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0745744', 'cui_str': 'End Stage Liver Disease'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0085605', 'cui_str': 'Hepatic Failure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",1200.0,0.117715,"Cenicriviroc (CVC) is a novel, orally administered, potent chemokine 2 and 5 receptor antagonist currently in development for the treatment of liver fibrosis in adults with NASH.
","[{'ForeName': 'Quentin M', 'Initials': 'QM', 'LastName': 'Anstee', 'Affiliation': 'Institute of Translational & Clinical Research, 4(th) floor, William Leech Building, The Medical School, Framlington Place, Newcastle University, Newcastle upon Tyne NE2 4HH, UK. Electronic address: quentin.anstee@newcastle.ac.uk.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Neuschwander-Tetri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Saint Louis University, 3635 Vista Avenue, St. Louis, MO 63110, USA.'}, {'ForeName': 'Vincent Wai-Sun', 'Initials': 'VW', 'LastName': 'Wong', 'Affiliation': 'Chinese University of Hong Kong, Department of Medicine and Therapeutics, 9/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, NT, Hong Kong, China.'}, {'ForeName': 'Manal F', 'Initials': 'MF', 'LastName': 'Abdelmalek', 'Affiliation': 'Duke University, 40 Duke Medicine Circle, Durham, NC 27710, USA.'}, {'ForeName': 'Zobair M', 'Initials': 'ZM', 'LastName': 'Younossi', 'Affiliation': 'Center for Liver Diseases and Department of Medicine, Inova Fairfax Medical Campus, 3300 Gallows Road, Falls Church, VA 22042, USA.'}, {'ForeName': 'Jiacheng', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Allergan plc, 2525 Dupont Drive, Irvine, CA 92612, USA.'}, {'ForeName': 'Maria Lucia', 'Initials': 'ML', 'LastName': 'Pecoraro', 'Affiliation': 'Allergan plc, 701 Gateway Boulevard, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Star', 'Initials': 'S', 'LastName': 'Seyedkazemi', 'Affiliation': 'Allergan plc, 701 Gateway Boulevard, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Fischer', 'Affiliation': 'Allergan plc, 701 Gateway Boulevard, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bedossa', 'Affiliation': 'Hôpital Beaujon, 100 Boulevard du Général Leclerc, 92110 Clichy, France.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Center for Liver Diseases and Department of Medicine, Inova Fairfax Medical Campus, 3300 Gallows Road, Falls Church, VA 22042, USA.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Texas Liver Institute, University of Texas Health Science Center, 607 Camden Street, Suite 108, San Antonio, TX 78215, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tacke', 'Affiliation': 'Charité University Medical Center Berlin, Augustenburger Platz 1, D-13353 Berlin, Germany.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University, 1201 East Marshall Street, Richmond, VA 23298, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105922']
1113,31952931,"Effectiveness of pretreatment with phosphoric acid, sodium hypochlorite and sulfinic acid sodium salt on root canal dentin resin bonding.","PURPOSE


The purpose of this study was to evaluate the effect of pretreatment using phosphoric acid, sodium hypochlorite and sulfinic acid sodium salt on the bonding of one-step self-etching adhesives to root canal dentin.
METHODS


Thirty-six single-rooted sound human premolars were randomly assigned into three groups before applying the one-step self-etching adhesive. These comprised a control group with no pretreatment, an NC group that received phosphoric acid and subsequent sodium hypochlorite gel pretreatments, and an NC+AC group that received an additional treatment with sulfinic acid sodium salt following the same pretreatment applied to the NC group. Microtensile bond strength measurements, bonding interface observations by scanning electron microscopy (SEM), elemental analyses by X-ray photoelectron spectroscopy (XPS) and degree of polymerization (DOP) analyses by Raman spectroscopy were subsequently performed.
RESULTS


The bond strength was significantly higher in the NC+AC group than in the other two groups (Control: P=000.1 and NC: P=0.004). SEM observations showed that resin tags were present in the dentinal tubules in the NC and NC+AC groups. Compared to the control group, the adhesive resin layer had a lower DOP in the NC group, while the DOP for the NC+AC group was higher than that of the NC specimens.
CONCLUSIONS


Bonding to root canal dentin was improved by applying sulfinic acid sodium salt in addition to treatment with phosphoric acid followed by sodium hypochlorite. The DOP of the adhesive resin was reduced by sodium hypochlorite and subsequently restored by applying sulfinic acid sodium salt.",2020,"Compared to the control group, the adhesive resin layer had a lower DOP in the NC group, while the DOP for the NC+AC group was higher than that of the NC specimens.
","['root canal dentin resin bonding', 'Thirty-six single-rooted sound human premolars']","['NC+AC', 'phosphoric acid, sodium hypochlorite and sulfinic acid sodium salt', 'scanning electron microscopy (SEM), elemental analyses by X-ray photoelectron spectroscopy (XPS', 'phosphoric acid, sodium hypochlorite and sulfinic acid sodium salt', 'sulfinic acid sodium salt', 'phosphoric acid and subsequent sodium hypochlorite gel pretreatments']","['DOP', 'bond strength', 'dentinal tubules']","[{'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}]","[{'cui': 'C0031700', 'cui_str': 'Phosphoric acid'}, {'cui': 'C0037518', 'cui_str': 'Sodium Hypochlorite'}, {'cui': 'C0038741', 'cui_str': 'Sulfinic Acids'}, {'cui': 'C0351302', 'cui_str': 'Sodium salts (substance)'}, {'cui': 'C0026019', 'cui_str': 'Electron Microscopy'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2700282', 'cui_str': 'X-Ray Photoelectron Spectroscopy'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0227017', 'cui_str': 'Dentinal tubules (body structure)'}]",36.0,0.0103586,"Compared to the control group, the adhesive resin layer had a lower DOP in the NC group, while the DOP for the NC+AC group was higher than that of the NC specimens.
","[{'ForeName': 'Hayaki', 'Initials': 'H', 'LastName': 'Nakatani', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Mine', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan. Electronic address: mine@dent.osaka-u.ac.jp.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Restorative Dentistry, Hokkaido University Graduate School of Dental Medicine, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Tajiri', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Hagino', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Yumitate', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Ban', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Miura', 'Affiliation': 'Division for Interdisciplinary Dentistry, Osaka University Dental Hospital, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Minamino', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Yatani', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, Japan.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2019.08.003']
1114,31314952,Nerve growth factor-induced muscle hyperalgesia facilitates ischaemic contraction-evoked pain.,"BACKGROUND


Intramuscular injection of Nerve Growth Factor (NGF) may influence the responsiveness of active chemo-sensitive channels affecting muscle pain sensitivity. This double-blinded crossover study in healthy humans assessed contraction-evoked pain responses and pain sensitivity during acute ischaemia in the tibialis anterior (TA) muscle before and 24 hr after five distributed NGF injections (1 µg, 4 cm interval) compared with control injections (isotonic-saline).
METHODS


Twenty-one subjects participated in two experimental phases, each including five sessions over 7 days, with a gap of 4 weeks in-between. Muscle pain intensity evoked with daily functional tasks (Likert scale score) was collected using a paper diary. Pain intensity evoked by ischaemic and non-ischaemic contractions numerical rating scale (NRS) was collected at Day0 and Day1. Pressure pain thresholds (PPTs) on the TA were recorded before (Day0), 3 hr, 1, 3, and 7 days post-injection, and after the ischaemic-contractions and post-cuff deflation at Day0 and Day1.
RESULTS


Increased Likert scores of pain were present for 7 days after NGF compared to control injections (p < .05). Higher NRS pain scores of ischaemic-contractions were seen when contracting the muscle injected with NGF compared to baseline (p = .003) and control (p = .012). Pain during non-ischaemic contractions was not significantly affected by NGF injections. Decreased PPTs were found at 3 hr, Day1 and Day3 post-injection (p < .05) in both conditions. Compared with pre-contractions, PPTs were increased following ischaemic contractions at Day0 (p < .05) and Day1 (p < .05) in both conditions.
CONCLUSION


This study showed that ischaemic contraction-evoked pain was facilitated in an NGF-sensitized muscle.
SIGNIFICANCE


Acidification of the muscle environment may affect muscle nociceptors and pain by different mechanisms, including activation of ASIC 3  and TRPV1. In this study, pain evoked following ischaemic contractions was increased in the Nerve Growth Factor (NGF)-sensitized muscle compared with non-ischaemic contractions and in the non-sensitized muscle. These findings illustrate that responses of peripheral afferents under ischaemic conditions are altered by a pre-sensitized muscle. This highlights the role of growth factors, including NGF, in peripheral muscle sensitization with clinical implications for ischaemic myalgia.",2019,"RESULTS


Increased Likert scores of pain were present for 7 days after NGF compared to control injections (p < .05).","['healthy humans assessed', 'Twenty-one subjects participated in two experimental phases, each including five sessions over 7\xa0days, with a gap of 4\xa0weeks in-between']","['control injections (isotonic-saline', 'Nerve Growth Factor (NGF']","['Higher NRS pain scores of ischaemic-contractions', 'contraction-evoked pain responses and pain sensitivity', 'ischaemic contraction-evoked pain', 'Likert scores of pain', 'Muscle pain intensity evoked with daily functional tasks (Likert scale score', 'Pressure pain thresholds (PPTs', 'Decreased PPTs', 'Pain', 'pain evoked following ischaemic contractions', 'Pain intensity evoked by ischaemic and non-ischaemic contractions numerical rating scale (NRS']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}]",21.0,0.0926177,"RESULTS


Increased Likert scores of pain were present for 7 days after NGF compared to control injections (p < .05).","[{'ForeName': 'Line Bay', 'Initials': 'LB', 'LastName': 'Sørensen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Gazerani', 'Affiliation': 'Biomedicine, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1455']
1115,31937442,Kinesiotaping for isolated rib fractures in emergency department.,"INTRODUCTION


Rib fractures, which are among the most common injuries in blunt thoracic trauma, are usually encountered in Emergency Departments. Kinesiotape (KT) is a drug-free elastic therapeutic tape used for treating various musculoskeletal problems such as injury, dysfunction and pain. We aimed to investigate whether kinesotaping should be used safely and effectively in rib fractures in emergency setting.
MATERIALS AND METHODS


This was a prospective, randomized controlled study conducted in an Emergency Department of a University Hospital. Patients diagnosed with isolated rib fractures were included in the study. Pain severity of patients assessed with 0-10 cm visual analog scale (VAS), then patients assigned into 2 treatment groups. One of them received treatment with flurbiprofen 200 mg/day and the other group received kinesiotaping in addition to the same oral therapy. On the 4th day of the procedure, both groups were assessed with VAS in the followup visit.
RESULTS


Total of 82 patients presented with rib fractures, 52 of them were excluded. Remaining 30 constituted the study group and randomly allocated to kinesiotaping (n = 16) or control group (n = 14). In both groups, pain intensity on the 4th day was significantly reduced when compared with baseline (p for both<0.01). Additionally, considering the reducing the pain intensity on 4th day, kinesiotaping was significantly superior than the control group (p < 0.01).
CONCLUSION


This study investigated the use of kinesiotaping in emergency departments. When compared to NSAID therapy alone, combined kinesiotaping and NSAID therapy appears to be more effective in terms of pain reduction in rib fractures.",2020,"Additionally, considering the reducing the pain intensity on 4th day, kinesiotaping was significantly superior than the control group (p < 0.01).
","['rib fractures in emergency setting', 'emergency departments', 'Total of 82 patients presented with rib fractures, 52 of them were excluded', 'Patients diagnosed with isolated rib fractures', 'isolated rib fractures in emergency department', 'Emergency Department of a University Hospital']","['NSAID therapy alone, combined kinesiotaping and NSAID therapy', 'Kinesiotape (KT', 'flurbiprofen']","['pain reduction', 'pain intensity', 'Pain severity']","[{'cui': 'C0035522', 'cui_str': 'Rib Fractures'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0016377', 'cui_str': 'Flurbiprofen'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",82.0,0.0341479,"Additionally, considering the reducing the pain intensity on 4th day, kinesiotaping was significantly superior than the control group (p < 0.01).
","[{'ForeName': 'Ali Haydar', 'Initials': 'AH', 'LastName': 'Akça', 'Affiliation': 'Yüzüncü Yıl University, Faculty of Medicine, Department of Emergency Medicine, Turkey.'}, {'ForeName': 'Muhammed İkbal', 'Initials': 'Mİ', 'LastName': 'Şaşmaz', 'Affiliation': 'Manisa Celal Bayar University, Faculty of Medicine, Department of Emergency Medicine, Turkey. Electronic address: ikbalsasmaz@hotmail.com.'}, {'ForeName': 'Şeyhmus', 'Initials': 'Ş', 'LastName': 'Kaplan', 'Affiliation': 'Yüzüncü Yıl University, Faculty of Medicine, Department of Sports Medicine, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.11.049']
1116,31935388,The effect of antenatal counseling and intrauterine device insertion services on postpartum contraceptive use in Nepal: Results from a stepped-wedge randomized controlled trial.,"OBJECTIVE


There is high unmet need for family planning in the postpartum period in Nepal. The current study assessed the effects of a contraceptive counseling and postpartum intrauterine device (PPIUD) insertion intervention on use of contraception in the postpartum period.
STUDY DESIGN


We utilized a cluster, stepped-wedge design to randomly assign two hospital clusters (compromised of six hospitals) to begin the intervention at time one or time two. From 2015 to 2017, women completed surveys after delivery but before discharge (n = 75,893), and then at one year and two years postpartum. We estimated the intent-to-treat effect of the intervention using weighted, linear probability models and the adherence-adjusted effect (antenatal counseling) using an instrumental variable approach. Outcomes included modern contraceptive use and method mix measured at one and two years postpartum in a sample of 19,298 women (year I follow-up sample) and a sample of 19,248 women (year II follow-up sample). We used inverse probability weights to adjust for incomplete follow-up and bootstrap methods to give correct causal inference with the small number of six clusters.
RESULTS


The intervention increased use of modern contraceptives by 3.8 percentage points [95% CI: -0.1, 9.5] at one-year postpartum, but only 0.3 percentage points [95% CI: -3.7, 4.1] at two years. The intervention significantly increased the use of PPIUDs at one year and two years postpartum, but there was less use of sterilization. Only 42% of women were counseled during the intervention period. The adherence-adjusted effects (antenatal counseling) were four times larger than the intent-to-treat effects.
CONCLUSIONS


Providing counseling during the antenatal period and PPIUD services in hospitals increased use of PPIUDs in the one- and two-year postpartum period and shifted the contraceptive method mix.
IMPLICATIONS


In order for antenatal counseling to increase postpartum contraceptive use, counseling may need to be provided in a wider range of prenatal care settings and at multiple time points. Healthcare providers should be trained on contraceptive counseling and PPIUD insertion, with the goal of expanding the available method mix and meeting postpartum women's contraceptive needs.",2020,"The intervention increased use of modern contraceptives by 3.8 percentage points [95% CI: -0.1, 9.5] at one-year postpartum, but only 0.3 percentage points [95% CI: -3.7, 4.1] at two years.","['19298 women (year I follow-up sample) and a sample of 19248 women (year II follow-up sample', 'Postpartum Contraceptive Use in Nepal']","['Antenatal Counseling and Intrauterine Device Insertion Services', 'contraceptive counseling and postpartum intrauterine device (PPIUD) insertion intervention']","['adherence-adjusted effects (antenatal counseling', 'modern contraceptive use and method mix']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1720722', 'cui_str': 'Mix'}]",,0.0789826,"The intervention increased use of modern contraceptives by 3.8 percentage points [95% CI: -0.1, 9.5] at one-year postpartum, but only 0.3 percentage points [95% CI: -3.7, 4.1] at two years.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Huber-Krum', 'Affiliation': 'Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA. Electronic address: shuber@hsph.harvard.edu.'}, {'ForeName': 'Aayush', 'Initials': 'A', 'LastName': 'Khadka', 'Affiliation': 'Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Pradhan', 'Affiliation': 'The World Bank Group, Washington, D.C., USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Rohr', 'Affiliation': 'Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Puri', 'Affiliation': 'Center for Research on Environment, Health and Population Activities (CREHPA), Kathmandu, Nepal.'}, {'ForeName': 'Dev', 'Initials': 'D', 'LastName': 'Maharjan', 'Affiliation': 'Center for Research on Environment, Health and Population Activities (CREHPA), Kathmandu, Nepal.'}, {'ForeName': 'Saugat', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Center for Research on Environment, Health and Population Activities (CREHPA), Kathmandu, Nepal.'}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Shah', 'Affiliation': 'Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Canning', 'Affiliation': 'Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",Contraception,['10.1016/j.contraception.2019.12.014']
1117,31933034,Exploring the feasibility of an exercise programme including aerobic and resistance training in people with limited cutaneous systemic sclerosis.,"OBJECTIVES


It is suggested that exercise can improve the vascular function and quality of life (QoL) in people with systemic sclerosis (SSc), potentially offering clinical benefits to this population. Yet the feasibility of such an intervention remains untested. Therefore, the purpose of this study is to examine the feasibility of a combined exercise protocol (aerobic and resistance training) in people with limited cutaneous SSc (lcSSc).
METHODS


Thirty-two lcSSc patients (66.5 ± 12 years old) were randomly allocated in two groups (exercise and control group). The exercise group underwent a 12-week exercise programme, twice per week. All patients performed the baseline, three- and six-month follow-up measurements where functional ability, body composition and QoL were assessed. Participants' experiences were explored through interviews.
RESULTS


Compliance was 92.6% with no dropouts. The individuals' confidence to participate in the study's exercise protocol for twice per week was 95%. The average value for the physical activity enjoyment scale was 103 ± 10 out of 119 (highest score). The mean values for the intention to engage in exercise twice per week were 6.4 ± 1 (likely) out of 7 (very likely). QoL for the exercise group showed to have a better life satisfaction, less anxiety and Raynaud's phenomenon-accompanied pain.
CONCLUSIONS


Our results suggest that a combined exercise protocol was feasible for people with lcSSc, with no adverse events, resulting in high adherence and low attrition rates, high enjoyment levels and intentions for future engagement to this exercise. Thus, the specific protocol is a safe adjunct therapy for people with lcSSc.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT number): NCT03058887, February 23, 2017, https://clinicaltrials.gov/ct2/show/NCT03058887?term=NCT03058887&rank=1Key Points• High-intensity interval training in combination with resistance training constitutes a feasible exercise protocol for people with lcSSc.• Overall, the exercise programme demonstrated high adherence and enjoyment levels and low attrition rates.• The exercise protocol was proved to be safe with no adverse events for people with lcSSc.",2020,"QoL for the exercise group showed to have a better life satisfaction, less anxiety and Raynaud's phenomenon-accompanied pain.
","['people with lcSSc.•', 'people with limited cutaneous systemic sclerosis', 'people with systemic sclerosis (SSc', 'people with limited cutaneous SSc (lcSSc', 'Thirty-two lcSSc patients (66.5\u2009±\u200912\xa0years old', 'people with lcSSc']","['exercise programme including aerobic and resistance training', 'combined exercise protocol (aerobic and resistance training', '12-week exercise programme', 'resistance training', 'https://clinicaltrials.gov/ct2/show/NCT03058887?term=NCT03058887&rank=1Key Points• High-intensity interval training', 'combined exercise protocol']","['adherence and enjoyment levels and low attrition rates.•', 'functional ability, body composition and QoL', 'physical activity enjoyment scale', 'vascular function and quality of life (QoL']","[{'cui': 'C0748540', 'cui_str': 'Scleroderma, Limited'}, {'cui': 'C0036421', 'cui_str': 'Systemic Scleroderma'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0222045'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0034380'}]",,0.0668499,"QoL for the exercise group showed to have a better life satisfaction, less anxiety and Raynaud's phenomenon-accompanied pain.
","[{'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Mitropoulos', 'Affiliation': 'Centre for Sport and Exercise Science, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Gumber', 'Affiliation': 'Centre for Health and Social Care Research, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Crank', 'Affiliation': 'Centre for Sport and Exercise Science, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Akil', 'Affiliation': 'Rheumatology Department, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Markos', 'Initials': 'M', 'LastName': 'Klonizakis', 'Affiliation': 'Centre for Sport and Exercise Science, Sheffield Hallam University, Sheffield, UK. m.klonizakis@shu.ac.uk.'}]",Clinical rheumatology,['10.1007/s10067-019-04921-7']
1118,31977929,Placebo effect in children: the role of expectation and learning.,"Classical conditioning and expectations are well-known underlying mechanisms of placebo hypoalgesia. Only little is known about their differential effect in adults, however, and even less in children. Previous studies in children evoked placebo hypoalgesia either with expectations alone or in combination with classical conditioning and revealed conflicting results. Furthermore, these studies investigated children of different ages making it even more difficult to draw conclusions. This study tried to disentangle classical conditioning and expectations by investigating them separately. To examine age effects, n = 172 children (6-9, 10-13, and 14-17 years) as well as n = 32 adults (> = 18 years) were tested using a heat pain paradigm investigating the effectiveness of creams some of which were bogusly introduced as analgesic. In addition to subjective pain intensity ratings, peripheral physiological measures were recorded. Results showed a successful induction of placebo hypoalgesia by both mechanisms for pain ratings and heart rate acceleration. Placebo hypoalgesia was particularly pronounced in children younger than 14 years. Furthermore, placebo hypoalgesia was more marked in children whose mothers raised the expectations. It was also stronger in participants who noticed a strong pain reduction during learning trials. These results encourage the use of placebo effect in clinical practice, particularly for younger children. They underline the relevance of an initial pain reduction and encourage the inclusion of parents in treatment.",2020,Placebo hypoalgesia was particularly pronounced in children under fourteen years.,"['children', '172 children (6-9, 10-13 and 14-17 years) as well as n = 32 adults (> 18 years', 'younger children', 'children under fourteen years']","['Placebo', 'placebo']","['pain ratings and heart rate acceleration', 'subjective pain intensity ratings peripheral physiological measures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",172.0,0.0940302,Placebo hypoalgesia was particularly pronounced in children under fourteen years.,"[{'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Gniß', 'Affiliation': 'Department of Clinical Psychology, Justus-Liebig-University Giessen, Giessen, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kappesser', 'Affiliation': ''}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Hermann', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000001811']
1119,31958991,"A Storytelling Intervention in a Mobile, Web-Based Platform: A Pilot Randomized Controlled Trial to Evaluate the Preliminary Effectiveness to Promote Human Papillomavirus Vaccination in Korean American College Women.","Korean American women have substantially greater incidence rates of cervical cancer and the lowest rates of cervical cancer screening in the United States. However, there has been minimal research to promote human papillomavirus (HPV) vaccination among this population. A pilot randomized controlled trial was conducted to evaluate preliminary effectiveness of a storytelling video intervention using mobile, Web-based technology. One hundred and four Korean American college women were randomized to the experimental group (storytelling video) or the comparison group (information-based written material). The effects of the intervention were assessed immediately postintervention and at the 2-month follow-up. Both groups improved in knowledge of and attitude toward the HPV vaccine at the postintervention. At the 2-month follow-up, the experimental group was twice as likely to receive the HPV vaccine compared to the comparison group. This preliminary evidence supports the use of a storytelling video intervention and shows substantial promise for further development and testing in larger scale studies.",2020,This preliminary evidence supports the use of a storytelling video intervention and shows substantial promise for further development and testing in larger scale studies.,"['Korean American women', 'One hundred and four Korean American college women', 'Korean American College Women']","['experimental group (storytelling video) or the comparison group (information-based written material', 'Promote Human Papillomavirus Vaccination', 'storytelling video intervention', 'storytelling video intervention using mobile, Web-based technology', 'HPV vaccine']",['knowledge of and attitude'],"[{'cui': 'C0597921', 'cui_str': 'Korean Americans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus (procedure)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",104.0,0.0631653,This preliminary evidence supports the use of a storytelling video intervention and shows substantial promise for further development and testing in larger scale studies.,"[{'ForeName': 'Minjin', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Haeok', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'University of Massachusetts Boston, Boston, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kiang', 'Affiliation': 'University of Massachusetts Boston, Boston, USA.'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Aronowitz', 'Affiliation': 'University of Massachusetts Boston, Boston, USA.'}, {'ForeName': 'Lisa Kennedy', 'Initials': 'LK', 'LastName': 'Sheldon', 'Affiliation': 'Oncology Nursing Society, Pittsburgh, USA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'University of Massachusetts Boston, Boston, USA.'}, {'ForeName': 'Jeroan J', 'Initials': 'JJ', 'LastName': 'Allison', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119894589']
1120,31925809,Effects of statin therapy and exercise on postprandial triglycerides in overweight individuals with hypercholesterolaemia.,"AIMS


To determine the effects of statins on postprandial lipaemia (PPL) and to study if exercise could enhance statin actions.
METHODS


Ten hypercholesteraemic (blood cholesterol 204 ± 36 mg dL -1  ; low-density lipoprotein-cholesterol 129 ± 32 36 mg dL -1  ) overweight (body mass index 30 ± 4 kg m -2  ), metabolic syndrome individuals chronically medicated with statins (>6 months) underwent 5-hour PPL tests in 4 occasions in a randomized order: (i) substituting their habitual statin medication by placebo for 96 hours (PLAC trial); (ii) taking their habitual statin medicine (STA trial); (iii) placebo combined with a bout of intense aerobic exercise (EXER+PLAC trial); and (iv) combining exercise and statin medicine (EXER+STA trial).
RESULTS


Before the fat meal, statin withdrawal (i.e. PLAC and EXER+PLAC) increased blood triglycerides (TG; 24%), low-density lipoprotein-cholesterol (31%) and total cholesterol (19%; all P < .05) evidencing treatment compliance. After the meal, statin withdrawal increased 5-hour postprandial TG (PPTG) compared to its matched trials (94% higher PLAC vs STA and 45% higher EXER+PLAC vs EXER+STA; P < .05). EXER+PLAC trial did not lower PPTG below PLAC (i.e. incremental AUC of 609 ± 152 vs 826 ± 190 mg dL -1  5 h; P = .09). Adding exercise to statin did not result in larger reductions in PPTG (i.e. EXER+STA vs STA incremental area under the curve of 421 ± 87 vs 421 ± 84 mg dL -1  5 h; P = .99).
CONCLUSION


In hypercholesteraemic metabolic syndrome individuals, chronic statin therapy blunts the elevations in TG after a fat meal (i.e. incremental area under the curve of PPTG) reducing the cardiovascular risk associated to their atherogenic dyslipidaemia. However, a single bout of intense aerobic exercise before the high fat meal, does not reduce PPTG but also does not interfere with the effects of statin treatment.",2020,"EXER+PLAC trial did not lower PPTG below PLAC (i.e., incremental AUC of 609±152 vs 826±190","[' LDL-c 129±32 36 mg·dL -1  ) overweight (BMI 30±4 kg·m -2  ), metabolic syndrome (MetS) individuals chronically medicated with statins (> 6 months', 'overweight individuals with hypercholesterolemia', 'Ten hypercholesterolemic (blood cholesterol', '204±36']","['habitual statin medication by placebo', 'placebo combined with a bout of intense aerobic exercise (EXER+PLAC trial) and d) combining exercise and statin medicine (EXER+STA trial', 'fat meal', 'EXER+PLAC', 'statins therapy and exercise', 'statins']","['postprandial triglycerides', 'blood triglycerides', 'total cholesterol', 'statin withdrawal increased 5-h postprandial TG (PPTG', 'LDL-c', 'mg·dL -1']","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0518018', 'cui_str': 'Blood triglycerides'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",10.0,0.111124,"EXER+PLAC trial did not lower PPTG below PLAC (i.e., incremental AUC of 609±152 vs 826±190","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Mora-Rodriguez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Juan Fernando', 'Initials': 'JF', 'LastName': 'Ortega', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Morales-Palomo', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ramirez-Jimenez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Moreno-Cabañas', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}]",British journal of clinical pharmacology,['10.1111/bcp.14217']
1121,31939265,"Extracorporeal shock wave therapy for treatment of vulvodynia: a prospective, randomized, double-blind, placebo-controlled study.","BACKGROUND


Currently, there are no effective therapy strategies for idiopathic, non-organic vulvodynia in women. ESWT (extracorporeal shock wave therapy) is a nonsurgical/noninvasive technique widely used to treat musculoskeletal diseases, muscle spasticity and hypertonia, renal and biliary calculi and urological disorders.
AIM


We examined the effects of ESWT on vulvodynia in women.
DESIGN


A prospective, randomized, double-blind, placebo-controlled study was conducted between 2015 and 2018 following a feasibility study.
SETTING


Obstetrics and Gynecology Hospital departments.
POPULATION


The study included 62 women with vulvodynia for at least 3 months.
METHODS


The women were randomly assigned to either a treatment group (N.=31) or a placebo group (N.=31). The patients in the treatment group received perineally applied ESWT weekly (3000 pulses each for four consecutive weeks). The energy flux density was 0.25 mJ/mm2, frequency 4 Hz, focus zone 0-30 mm, therapeutic efficacy 0-90 mm, stand-off II. The device used was a standard electromagnetic shock wave unit with a focused shock wave handpiece. The position of the shock wave transducer was changed six times after every 500 pulses. Patients in the placebo group underwent the same treatment procedure, but the handpiece was provided with a placebo stand-off that disabled energy transmission. Subjective pain was self-evaluated by each patient using two tools before and after treatment: a 10 cm linear visual analogue scale (VAS, 0-10) and a cotton-swab test (CST, Goetsch scale 0-4). Follow-ups were done 1, 4, and 12 weeks post-ESWT.
RESULTS


In all, 61 women completed the study. We tested for differences in the VAS and CST within and between the treatment and placebo groups. The testing was between before treatment and particular follow-up. We found significant changes in the treatment group. Reductions in VAS (P<0.01) and CST (P<0.01) were observed at all three follow-ups. At all assessments, pain reduction was always >30%. In the placebo group there were no statistically significant changes between before and after treatment. There were no differences between the treatment and placebo groups before treatment but statistically significant differences at all three follow-ups (VAS P<0.01); CST P<0.01).
CONCLUSIONS


ESWT seems to reduce pain perception in our treatment group. Thus, we are encouraged to explore this technique further.
CLINICAL REHABILITATION IMPACT


The method is easily replicable, inexpensive, and without known side effects.",2020,"There were no differences between the treatment and placebo groups before treatment but statistically significant differences at all three follow-ups (VAS p<0.01); CST p<0.01).
","['2015 and 2018 following a feasibility study', 'women', '62 women with vulvodynia for at least 3 months', 'vulvodynia', '61 women completed the study']","['perineally applied ESWT', 'Extracorporeal shock wave therapy', 'ESWT (extracorporeal shock wave therapy', 'ESWT', 'placebo', 'placebo stand- off that disabled energy transmission']","['pain perception', 'pain reduction', 'Reductions in VAS', 'Subjective pain', 'energy flux density']","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0015730', 'cui_str': 'Feasibility Studies'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0406670', 'cui_str': 'Vulvodynias'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0522650', 'cui_str': 'External prosthesis for sonographic procedure, device (physical object)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}]","[{'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",62.0,0.185785,"There were no differences between the treatment and placebo groups before treatment but statistically significant differences at all three follow-ups (VAS p<0.01); CST p<0.01).
","[{'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Hurt', 'Affiliation': 'Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University, Prague, Czech Republic - hurt@infoprague.com.'}, {'ForeName': 'Frantisek', 'Initials': 'F', 'LastName': 'Zahalka', 'Affiliation': 'Sports Motoric Laboratory, Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Halaska', 'Affiliation': 'Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Rakovicova', 'Affiliation': 'OBGYN Department Amedeana Prague, Prague, Czech Republic.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Krajcova', 'Affiliation': 'Department of Plastic Surgery, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.05903-1']
1122,30770308,Clinical Benefit-Risk Profile of Lenalidomide in Patients With Lower-risk Myelodysplastic Syndromes Without del(5q): Results of a Phase III Trial.,"BACKGROUND


In the phase III MDS-005 study of patients with lower-risk, non-del(5q) myelodysplastic syndromes, lenalidomide was associated with a higher rate of ≥ 8 weeks red blood cell transfusion independence (RBC-TI) compared with placebo, but also with a higher risk of hematologic adverse events (AEs).
PATIENTS AND METHODS


This analysis evaluated the ratio of clinical benefit-risk in patients treated with lenalidomide or placebo, and assessed the effect of lenalidomide dose reductions on response. Clinical benefit was a composite endpoint defined as RBC-TI, transfusion reduction ≥ 4 units packed red blood cells, hemoglobin increase ≥ 1.5 g/dL, or cytogenetic response.
RESULTS


The rate of clinical benefit was higher with lenalidomide than with placebo (31.9% vs. 3.8%). The ratio of response (RBC-TI and clinical benefit) to risk (hematologic AEs) favored lenalidomide over placebo. Patients who underwent ≥ 1 lenalidomide dose reduction had a longer duration of treatment, received a higher cumulative dose, and were more likely to experience clinical benefit versus patients without dose reductions.
CONCLUSION


Despite the occurrence of hematologic AEs, the overall benefit-risk profile supported lenalidomide treatment. Appropriate management of hematologic AEs by dose reductions may help patients with myelodysplastic syndromes to remain on treatment and achieve clinical benefit.",2019,"Clinical benefit was a composite endpoint defined as RBC-TI, transfusion reduction ≥ 4 units packed red blood cells, hemoglobin increase ≥ 1.5 g/dL, or cytogenetic response.
","['patients with lower-risk, non-del(5q) myelodysplastic syndromes', 'Patients With Lower-risk Myelodysplastic Syndromes Without del(5q', 'patients with myelodysplastic syndromes']","['placebo', 'Lenalidomide', 'lenalidomide or placebo']","['RBC-TI, transfusion reduction\xa0≥ 4 units packed red blood cells, hemoglobin increase\xa0≥ 1.5 g/dL, or cytogenetic response', 'rate of clinical benefit', 'ratio of response (RBC-TI and clinical benefit) to risk (hematologic AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C2316467', 'cui_str': ""Packed red blood cells (PRBC's)""}, {'cui': 'C0549448', 'cui_str': 'Increased hemoglobin (finding)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}]",,0.143286,"Clinical benefit was a composite endpoint defined as RBC-TI, transfusion reduction ≥ 4 units packed red blood cells, hemoglobin increase ≥ 1.5 g/dL, or cytogenetic response.
","[{'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'Department of Leukemia, MD Anderson Cancer Center, Houston, TX. Electronic address: ggarciam@mdanderson.org.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Almeida', 'Affiliation': 'Department of Hematology, Hospital da Luz, Lisbon, Portugal.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Fenaux', 'Affiliation': ""Service d'Hématologie Séniors, Hôpital Saint-Louis, Université Paris 7, Paris, France.""}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Gattermann', 'Affiliation': 'Klinik für Hämatologie, Onkologie und Klinische Immunologie, Heinrich-Heine-Universität, Düsseldorf, Germany.'}, {'ForeName': 'Aristoteles', 'Initials': 'A', 'LastName': 'Giagounidis', 'Affiliation': 'Department of Oncology, Hematology and Palliative Care, Marien Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Stuart L', 'Initials': 'SL', 'LastName': 'Goldberg', 'Affiliation': 'John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ.'}, {'ForeName': 'Keiya', 'Initials': 'K', 'LastName': 'Ozawa', 'Affiliation': 'The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Weaver', 'Affiliation': 'Celgene Corporation, Summit, NJ.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Santini', 'Affiliation': 'MDS Unit, AOU Careggi, University of Florence, Florence, Italy.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2018.12.012']
1123,31915511,"A Randomized Pilot Trial to Evaluate the Bioavailability of Natural versus Synthetic Vitamin B Complexes in Healthy Humans and Their Effects on Homocysteine, Oxidative Stress, and Antioxidant Levels.","The vitamin B complex comprises 8 different water-soluble constituents that humans must sequester from the diet. This pilot study compared natural versus synthetic vitamin B complexes for their bioavailability, accumulation, and their impact on antioxidants, homocysteine levels, and oxidative stress. We conducted a double-blind randomized clinical trial with thirty healthy participants. They were randomly assigned to group N (natural) and group S (synthetic). Vitamin B was ingested daily for 6 weeks in the range of about 2.5 times above the recommended daily allowance. Blood samples were taken at baseline, 1.5 h, 4 h, 7 h (diurnal), 6 w (discontinuation of supplements), and 8 w (washout). Blood levels of thiamine (B 1 ), riboflavin (B 2 ), pyridoxine (B 6 ), folic acid (B 9 ), cobalamin (B 12 ), homocysteine, total antioxidants, peroxidase activity, polyphenols, and total peroxides were determined. Compared to initial values, serum levels of each B vitamin increased at the end of the supplementation period: i.e., B 1  (+23% N; +27% S), B 2  (+14% N; +13% S), B 6  (+101% N; +101% S), B 9  (+86% N; +153% S), and B 12  (+16% N) ( p  < 0.05). Homocysteine (-13% N) decreased, while peroxidase activity (+41% S) and antioxidant capacity increased (+26% N). Short-term effects were already observed after 1.5 h for B 9  (+238% N; +246% S) and after 4 h for vitamin B 2  (+7% N; +8% S), B 6  (+59% N; +51% S), and peroxidase activity (+58% N; +58% S). During the washout period, serum levels of B vitamins decreased except for thiamine and peroxidase activity, which increased further. This clinical pilot study revealed comparable bioavailability for both natural and synthetic B vitamins but did not show statistically noticeable differences between groups despite some favourable tendencies within the natural vitamin group, i.e., sustained effects for cobalamin and endogenous peroxidase activity and a decrease in homocysteine and oxidative stress levels.",2019,"This clinical pilot study revealed comparable bioavailability for both natural and synthetic B vitamins but did not show statistically noticeable differences between groups despite some favourable tendencies within the natural vitamin group, i.e., sustained effects for cobalamin and endogenous peroxidase activity and a decrease in homocysteine and oxidative stress levels.","['Healthy Humans', 'thirty healthy participants']","['synthetic vitamin B complexes', 'Natural versus Synthetic Vitamin B Complexes', 'Vitamin B']","['antioxidants, homocysteine levels, and oxidative stress', 'serum levels of each B vitamin', 'Homocysteine', 'antioxidant capacity', 'peroxidase activity', 'Homocysteine, Oxidative Stress, and Antioxidant Levels', 'homocysteine and oxidative stress levels', 'Blood levels of thiamine (B 1 ), riboflavin (B 2 ), pyridoxine (B 6 ), folic acid (B 9 ), cobalamin (B 12 ), homocysteine, total antioxidants, peroxidase activity, polyphenols, and total peroxides']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3714647', 'cui_str': 'B Vitamins'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0031179', 'cui_str': 'Peroxidases'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}, {'cui': 'C0373720', 'cui_str': 'Vitamin B2'}, {'cui': 'C0045550', 'cui_str': 'sodium 2,5-dichloro-4-bromophenol'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0086024', 'cui_str': 'Cobalamins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0031180', 'cui_str': 'Peroxides'}]",,0.107465,"This clinical pilot study revealed comparable bioavailability for both natural and synthetic B vitamins but did not show statistically noticeable differences between groups despite some favourable tendencies within the natural vitamin group, i.e., sustained effects for cobalamin and endogenous peroxidase activity and a decrease in homocysteine and oxidative stress levels.","[{'ForeName': 'Meinrad', 'Initials': 'M', 'LastName': 'Lindschinger', 'Affiliation': 'Institute of Nutritional and Metabolic Diseases, Outpatient Clinic Laßnitzhöhe, Laßnitzhöhe, Austria.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Tatzber', 'Affiliation': 'Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Chair of Immunology and Pathophysiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schimetta', 'Affiliation': 'Department of Applied Systems Research and Statistics, Johannes Kepler University, Linz, Austria.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schmid', 'Affiliation': 'Institute of Nutritional and Metabolic Diseases, Outpatient Clinic Laßnitzhöhe, Laßnitzhöhe, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lindschinger', 'Affiliation': 'Institute of Nutritional and Metabolic Diseases, Outpatient Clinic Laßnitzhöhe, Laßnitzhöhe, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Cvirn', 'Affiliation': 'Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Chair of Physiological Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Stanger', 'Affiliation': 'Helios Clinic Munich West, Clinic for Vascular and Endovascular Surgery, Munich-Pasing, Germany.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Lamont', 'Affiliation': 'Clinic Section for Surgical Research Department of Surgery Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Willibald', 'Initials': 'W', 'LastName': 'Wonisch', 'Affiliation': 'Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Chair of Physiological Medicine, Medical University of Graz, Graz, Austria.'}]",Oxidative medicine and cellular longevity,['10.1155/2019/6082613']
1124,31942969,Falls Risk in Relation to Activity Exposure in High-Risk Older Adults.,"BACKGROUND


Physical activity is linked to many positive health outcomes, stimulating the development of exercise programs. However, many falls occur while walking and so promoting activity might paradoxically increase fall rates, causing injuries, and worse quality of life. The relationship between activity exposure and fall rates remains unclear. We investigated the relationship between walking activity (exposure to risk) and fall rates before and after an exercise program (V-TIME).
METHODS


One hundred and nine older fallers, 38 fallers with mild cognitive impairment (MCI), and 128 fallers with Parkinson's disease (PD) were randomly assigned to one of two active interventions: treadmill training only or treadmill training combined with a virtual reality component. Participants were tested before and after the interventions. Free-living walking activity was characterized by volume, pattern, and variability of ambulatory bouts using an accelerometer positioned on the lower back for 1 week. To evaluate that relationship between fall risk and activity, a normalized index was determined expressing fall rates relative to activity exposure (FRA index), with higher scores indicating a higher risk of falls per steps taken.
RESULTS


At baseline, the FRA index was higher for fallers with PD compared to those with MCI and older fallers. Walking activity did not change after the intervention for the groups but the FRA index decreased significantly for all groups (p ≤ .035).
CONCLUSIONS


This work showed that V-TIME interventions reduced falls risk without concurrent change in walking activity. We recommend using the FRA index in future fall prevention studies to better understand the nature of intervention programs.",2020,"Walking activity did not change after the intervention for the groups but the FRA index decreased significantly for all groups (p≤0.035).
","['high risk older adults', ""109 elderly fallers, 38 people with mild cognitive impairment (MCI) and 128 people with Parkinson's disease (PD""]",['treadmill training only or treadmill training combined with a virtual reality component'],"['Walking activity', 'walking activity (exposure to risk) and fall rates', 'falls risk', 'walking activity', 'FRA index', 'Free-living walking activity', 'fall rates, causing injuries and worse quality of life']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0086315', 'cui_str': 'FRAs'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0034380'}]",109.0,0.021465,"Walking activity did not change after the intervention for the groups but the FRA index decreased significantly for all groups (p≤0.035).
","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Del Din', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Brook', 'Initials': 'B', 'LastName': 'Galna', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Lord', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Nieuwboer', 'Affiliation': 'KU Leuven, Department of Rehabilitation Sciences, Neuromotor Rehabilitation Research Group, Belgium.'}, {'ForeName': 'Esther M J', 'Initials': 'EMJ', 'LastName': 'Bekkers', 'Affiliation': 'KU Leuven, Department of Rehabilitation Sciences, Neuromotor Rehabilitation Research Group, Belgium.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pelosin', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal Child Health, University of Genova, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Avanzino', 'Affiliation': 'Ospedale Policlinico San Martino-IRCCS, Genoa, Italy.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Marcel G M', 'Initials': 'MGM', 'LastName': 'Olde Rikkert', 'Affiliation': 'Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Freek', 'Initials': 'F', 'LastName': 'Nieuwhof', 'Affiliation': 'Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, The Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cereatti', 'Affiliation': 'Department of Biomedical Sciences, Bioengineering Unit, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Della Croce', 'Affiliation': 'Department of Biomedical Sciences, Bioengineering Unit, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Mirelman', 'Affiliation': 'Laboratory for Early Markers of Neurodegeneration, Center for the study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Israel.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': 'Laboratory for Early Markers of Neurodegeneration, Center for the study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Israel.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa007']
1125,31090078,Pharmacokinetic Analysis and Biomarker-Assisted Safety Assessment of Acetaminophen in Combination With Ojeok-san Compared With Acetaminophen Alone.,"Acetaminophen and Ojeok-san are both frequently used analgesics. In this study, we evaluated acetaminophen pharmacokinetics (PK) and changes in microRNA-122 (miR-122) levels after multiple dosing of acetaminophen with or without Ojeok-san. An open-label, 1-sequence, 2-period, 2-treatment crossover study was conducted in 18 subjects. In period 1, 500 mg of acetaminophen was administered 3 times on day 1 and once on day 2. In period 2, after the administration of 14.47 g of Ojeok-san twice on day 2 and 3 times daily on days 3 to 7, Ojeok-san and acetaminophen were coadministered 3 times each on day 8 and once each on day 9. The geometric mean ratios (90% confidence intervals) of acetaminophen with Ojeok-san to acetaminophen alone were 0.98 (0.87 to 1.10) and 1.02 (0.98 to 1.05) for the maximum plasma concentration (C max  ) and the area under the plasma concentration-time curve during the dosing interval (AUC 0-τ  ), respectively, of acetaminophen at steady state. The alanine aminotransferase (ALT) levels were within the reference range in all the participants throughout the study period, although the mean fold changes in both serum miR-122 and ALT levels from baseline tended to increase on days 2 to 5. In conclusion, the PK properties of acetaminophen were not significantly affected by Ojeok-san coadministration. For osteoarthritis patients taking acetaminophen with or without Ojeok-san, monitoring potential liver toxicity using miR-122 as a biomarker may be useful.",2019,"The geometric mean ratios (90% confidence intervals) of acetaminophen with Ojeok-san to acetaminophen alone were 0.98 (0.87 to 1.10) and 1.02 (0.98 to 1.05) for the maximum plasma concentration (C max  ) and the area under the plasma concentration-time curve during the dosing interval (AUC 0-τ  ), respectively, of acetaminophen at steady state.",['18 subjects'],"['acetaminophen with or without Ojeok-san', 'Ojeok-san and acetaminophen', 'Acetaminophen and Ojeok-san', 'Acetaminophen', 'Ojeok-san', 'acetaminophen']","['geometric mean ratios', 'maximum plasma concentration (C max  ) and the area under the plasma concentration-time curve', 'acetaminophen pharmacokinetics (PK) and changes in microRNA-122 (miR-122) levels', 'alanine aminotransferase', 'PK properties of acetaminophen', 'ALT) levels', 'serum miR-122 and ALT levels']",[],"[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C3850922', 'cui_str': 'ojeok-san'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1101610', 'cui_str': 'miRNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.0386118,"The geometric mean ratios (90% confidence intervals) of acetaminophen with Ojeok-san to acetaminophen alone were 0.98 (0.87 to 1.10) and 1.02 (0.98 to 1.05) for the maximum plasma concentration (C max  ) and the area under the plasma concentration-time curve during the dosing interval (AUC 0-τ  ), respectively, of acetaminophen at steady state.","[{'ForeName': 'Sang-In', 'Initials': 'SI', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyung Hee University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Mun Su', 'Initials': 'MS', 'LastName': 'Park', 'Affiliation': 'Department of Biomedical Science and Technology, Graduate School, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Tae', 'Initials': 'KT', 'LastName': 'Lee', 'Affiliation': 'Department of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Sung-Vin', 'Initials': 'SV', 'LastName': 'Yim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyung Hee University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Ran', 'Initials': 'YR', 'LastName': 'Yoon', 'Affiliation': 'School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Bo-Hyung', 'Initials': 'BH', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Kyung Hee University Hospital, Seoul, Republic of Korea.'}]",Journal of clinical pharmacology,['10.1002/jcph.1439']
1126,31919654,Kinesiology training in patients with Parkinson's disease: results of a pilot study.,"Complementary therapies are an essential component of the treatment of patients with Parkinson's disease. They aim to ameliorate disease symptoms in conjunction with dopamine substitution. Kinesiology trains about the effective use of physical, mental and emotional skills. Objectives of this pilot study were to demonstrate the efficacy of a standardised kinesiology programme in 20 patients with Parkinson's disease. They were on a stable drug regimen during the whole trial. Ten patients received two kinesiology sessions per week over a 6-week lasting interval. The remaining ten patients were only followed over the same time period without any kinesiology training. We scored disease symptoms, tested cognition and assessed instrumental movement performance at baseline and study end. Kinesiology improved disease symptoms, cognitive abilities and execution of simple but not complex movement series. We show a certain value of a standardised kinesiology programme as adjunct, complementary therapeutic approach in patients with Parkinson's disease.",2020,"Kinesiology improved disease symptoms, cognitive abilities and execution of simple but not complex movement series.","[""20 patients with Parkinson's disease"", ""patients with Parkinson's disease""]","['dopamine substitution', 'Kinesiology training', 'standardised kinesiology programme']","['disease symptoms, cognitive abilities and execution of simple but not complex movement series']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}]",,0.018337,"Kinesiology improved disease symptoms, cognitive abilities and execution of simple but not complex movement series.","[{'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Kuhn', 'Affiliation': 'Department of Neurology, Leopoldina Hospital Schweinfurt, Gustav Adolf Str. 8, 97422, Schweinfurt, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Neufeld', 'Affiliation': 'Department of Neurology, Leopoldina Hospital Schweinfurt, Gustav Adolf Str. 8, 97422, Schweinfurt, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Müller', 'Affiliation': 'Department of Neurology, St. Joseph Hospital Berlin-Weissensee, Gartenstr. 1, 13088, Berlin, Germany. th.mueller@alexianer.de.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-019-02123-8']
1127,31930308,Early postoperative statin administration does not affect the rate of atrial fibrillation after cardiac surgery.,"OBJECTIVES


Postoperative atrial fibrillation is the most frequent complication after cardiac surgery, and the use of statins in preventing them is being extensively studied. The aim of this study was to investigate whether a pause in the administration of statins affects the occurrence of atrial fibrillation after cardiac surgery in a prospective randomized and controlled setting.
METHODS


A total of 301 patients without chronic atrial fibrillation with prior statin medication scheduled for elective or urgent cardiac surgery involving the coronary arteries and/or heart valves were prospectively recruited and randomized for statin re-initiation on either the first (immediate statin group) or the fifth (late statin group) postoperative day, using the original medication and dosage. The immediate statin group comprised 146 patients and the late statin group 155 patients. Except for a somewhat higher rate of males (85% vs 73%, P = 0.016) in the immediate statin group, the baseline characteristics and the distribution of procedures performed within the groups were comparable. The occurrence of postoperative atrial fibrillation and the clinical course of the patients were compared between the groups.
RESULTS


The incidence of atrial fibrillation was 46% and the median delay after surgery before the onset of atrial fibrillation was 3 days in both groups (P = NS). No differences were observed in the frequency of the arrhythmia in any subgroup analyses or in other major complications or clinical parameters. No adverse effects related to early statin administration were detected.
CONCLUSIONS


Early re-initiation of statins does not appear to affect the occurrence of postoperative atrial fibrillation.
CLINICAL TRIAL REGISTRATION


European Union Drug Regulating Authorities Clinical Trials Database (EudraCT)-2016-001655-44.",2020,"Except for a somewhat higher rate of males (85% vs 73%, P = 0.016) in the immediate statin group, the baseline characteristics and the distribution of procedures performed within the groups were comparable.","['146 patients and the late statin group 155 patients', '301 patients without chronic atrial fibrillation with prior statin medication scheduled for elective or urgent cardiac surgery involving the coronary arteries and/or heart valves']",['statins'],"['occurrence of postoperative atrial fibrillation', 'frequency of the arrhythmia', 'rate of atrial fibrillation', 'incidence of atrial fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0694539', 'cui_str': 'Chronic atrial fibrillation (disorder)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0018826', 'cui_str': 'Cardiac Valves'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",301.0,0.0957169,"Except for a somewhat higher rate of males (85% vs 73%, P = 0.016) in the immediate statin group, the baseline characteristics and the distribution of procedures performed within the groups were comparable.","[{'ForeName': 'Jahangir A', 'Initials': 'JA', 'LastName': 'Khan', 'Affiliation': 'Department of Cardio-Thoracic Surgery, Tays Heart Hospital, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Jari O', 'Initials': 'JO', 'LastName': 'Laurikka', 'Affiliation': 'Department of Cardio-Thoracic Surgery, Tays Heart Hospital, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Otto H', 'Initials': 'OH', 'LastName': 'Järvinen', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Niina K', 'Initials': 'NK', 'LastName': 'Khan', 'Affiliation': 'Centre for Vascular Surgery and Interventional Radiology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Kati M', 'Initials': 'KM', 'LastName': 'Järvelä', 'Affiliation': 'Department of Cardio-Thoracic Surgery, Tays Heart Hospital, Tampere University Hospital, Tampere, Finland.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezz365']
1128,31930338,Serious Adverse Events Cluster in Participants Experiencing the Primary Composite Cardiovascular Endpoint: A Post Hoc Analysis of the SPRINT Trial.,"BACKGROUND


Intensively treated participants in the SPRINT study experienced fewer primary cardiovascular composite study endpoints (CVD events) and lower mortality, although 38% of participants experienced a serious adverse event (SAE). The relationship of SAEs with CVD events is unknown.
METHODS


CVD events were defined as either myocardial infarction, acute coronary syndrome, decompensated heart failure, stroke, or death from cardiovascular causes. Cox models were utilized to understand the occurrence of SAEs with CVD events according to baseline atherosclerotic cardiovascular disease (ASCVD) risk.
RESULTS


SAEs occurred in 96% of those experiencing a CVD event but only in 34% (P < 0.001) of those not experiencing a CVD event. Occurrence of SAEs monotonically increased across the range of baseline ASCVD risk being approximately twice as great in the highest compared with the lowest risk category. SAE occurrence was strongly associated with ASCVD risk but was similar within risk groups across treatment arms. In adjusted Cox models, experiencing a CVD event was the strongest predictor of SAEs in all risk groups. By the end of year 1, the hazard ratios for the low, middle, and high ASCVD risk tertiles, and baseline clinical CVD group were 2.56 (95% CI = 1.39-4.71); 2.52 (1.63-3.89); 3.61 (2.79-4.68); 1.86 (1.37-2.54), respectively-a trend observed in subsequent years until study end. Intensive treatment independently predicted SAEs only in the second ASVCD risk tertile.
CONCLUSIONS


The occurrence of SAEs is multifactorial and mostly related to prerandomization patient characteristics, most prominently ASCVD risk, which, in turn, relates to in-study CVD events.",2020,"RESULTS


SAEs occurred in 96% of those experiencing a CVD event but only in 34% (p < 0.001) of those not experiencing a CVD event.",['Participants Experiencing the Primary Composite Cardiovascular Endpoint'],[],"['myocardial infarction, acute coronary syndrome, decompensated heart failure, stroke, or death from cardiovascular causes', 'SAEs', 'hazard ratios', 'ASCVD risk', 'SAE occurrence', 'serious adverse event (SAE']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",[],"[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0777405,"RESULTS


SAEs occurred in 96% of those experiencing a CVD event but only in 34% (p < 0.001) of those not experiencing a CVD event.","[{'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Botchway', 'Affiliation': 'Department of Internal Medicine, Southern Illinois University School of Medicine, Springfield, Illinois, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Buhnerkempe', 'Affiliation': 'Department of Internal Medicine, Southern Illinois University School of Medicine, Springfield, Illinois, USA.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Prakash', 'Affiliation': 'Center for Clinical Research, Southern Illinois University School of Medicine, Springfield, Illinois, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Al-Akchar', 'Affiliation': 'Department of Internal Medicine, Southern Illinois University School of Medicine, Springfield, Illinois, USA.'}, {'ForeName': 'Bemi', 'Initials': 'B', 'LastName': 'Adekola', 'Affiliation': 'Division of General Internal Medicine, Hypertension Section, Department of Internal Medicine, Southern Illinois University School of Medicine, Springfield, Illinois, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Flack', 'Affiliation': 'Division of General Internal Medicine, Hypertension Section, Department of Internal Medicine, Southern Illinois University School of Medicine, Springfield, Illinois, USA.'}]",American journal of hypertension,['10.1093/ajh/hpaa010']
1129,31866488,Randomized Controlled Trial of Advance Care Planning Video Decision Aid for the General Population.,"CONTEXT


Advance care planning (ACP) in a healthy general population could improve the quality of care when a health problem arises.
OBJECTIVES


The purpose of this study was to evaluate the efficacy of video decision support aid in increasing the intention to document ACP in the general healthy population.
METHODS


In this randomized controlled trial, we enrolled 250 members of the general population (aged 20 years and older and determined to be healthy), stratified by age and sex. The intervention was a video that provided information about ACP and end-of-life care options such as cardiopulmonary resuscitation (CPR) and palliative care. An attention-control arm was given a booklet about advance directives. Primary outcome was a change in intention to document ACP. Secondary outcomes included the intention to refuse CPR at terminal status, CPR and palliative care knowledge score, and the Hospital Anxiety and Depression Scale.
RESULTS


About 250 participants were randomly assigned, half to the video-assisted intervention group and half to the attention-control group. Within one week postintervention, the intention to document ACP was significantly higher in the video-assisted intervention arm (68.0% vs. 39.2%; P < 0.001), and changes in the intention to document ACP were significantly greater in the video group than in the brochure group (P = 0.008; Δ = 14.4%). Palliative care knowledge score was also significantly increased in the video group (P = 0.036).
CONCLUSION


A well-constructed video decision support intervention can increase the intention to document ACP in the general population that presumably had little opportunity to discuss ACP with physicians.",2020,"Within 1 week post-intervention, the intention to document ACP was significantly higher in the video-assisted intervention arm (68.0% vs 39.2%; p < 0.001) and changes in the intention to document ACP were significantly greater in the video group than in the brochure group (p = 0.008; Δ = 14.4%).","['250 participants', 'enrolled 250 members of the general population (aged ≥20 years and determined to be healthy), stratified by age and sex']","['video-assisted intervention group and half to the attention-control group', 'video decision-support aid']","['change in intention to document ACP', 'intention to refuse CPR at terminal status, CPR and palliative care knowledge score, and the Hospital Anxiety and Depression Scale (HADS', 'Palliative care knowledge score', 'intention to document ACP']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]",250.0,0.115523,"Within 1 week post-intervention, the intention to document ACP was significantly higher in the video-assisted intervention arm (68.0% vs 39.2%; p < 0.001) and changes in the intention to document ACP were significantly greater in the video group than in the brochure group (p = 0.008; Δ = 14.4%).","[{'ForeName': 'EunKyo', 'Initials': 'E', 'LastName': 'Kang', 'Affiliation': 'Department of Family Medicine, Seoul National University Hospital, Jongno gu, Seoul, Korea; Institute for Public Health and Medical Service, Seoul National University Hospital, Jongno-gu, Seoul, Korea.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Science, Seoul National University College of Medicine, Jongno gu, Seoul, Korea.'}, {'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Choo', 'Affiliation': 'Department of Biomedical Science, Seoul National University College of Medicine, Jongno gu, Seoul, Korea.'}, {'ForeName': 'JeongHee', 'Initials': 'J', 'LastName': 'Min', 'Affiliation': 'Department of Biomedical Science, Seoul National University College of Medicine, Jongno gu, Seoul, Korea.'}, {'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Yun', 'Affiliation': 'Department of Family Medicine, Seoul National University Hospital, Jongno gu, Seoul, Korea; Department of Biomedical Science, Seoul National University College of Medicine, Jongno gu, Seoul, Korea. Electronic address: lawyun08@gmail.com.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.12.353']
1130,31559633,Does the time-point of orthodontic space closure initiation after tooth extraction affect the incidence of gingival cleft development? A randomized controlled clinical trial.,"BACKGROUND


Gingival clefts (GCs) develop frequently during orthodontic space closure and may compromise the treatment outcome. This study assessed whether the time-point of orthodontic space closure initiation, after permanent tooth extraction, affects the incidence of GC.
METHODS


In 25 patients requiring bilateral premolar extraction because of orthodontic reasons, one premolar, chosen at random, was extracted 8 weeks before space closure initiation (""delayed movement,"" DM), whereas the contralateral premolar was extracted 1 week before (""early movement,"" EM) (""treatment group""). Presence or absence of GC after 3 and 6 months (""time-point"") was recorded and any association with various parameters (i.e., treatment group, time-point, gender, jaw, craniofacial growth, gingival biotype, buccal bone dehiscence after extraction, space closure) was statistically assessed.
RESULTS


Twenty-one patients contributing with 26 jaws were finally included in the analysis. Overall, GCs were frequent after 3 (DM: 53.9%; EM: 69.2%) and 6 months (DM: 76.9%; EM: 88.5%). EM (P = 0.014) and larger space closure within the study period (P = 0.001) resulted in a significantly higher incidence of GC. Further, there was a tendency for GC development in the presence of buccal bone dehiscence (P = 0.052) and thin gingival biotype (P = 0.054). ""Fast movers"" (herein cases with a tooth movement ≥1 mm per month) developed a GC in >90% of the cases already after 3 months. ""Slow movers"" developed a GC in 25% and 70% after 3 months and final evaluation, respectively.
CONCLUSIONS


GC development is a frequent finding during orthodontic space closure and seems to occur more frequently with early tooth movement initiation and in ""fast movers.""",2020,EM (p = 0.014) and larger space closure within the study period (p = 0.001) resulted in a significantly higher incidence of GC.,"['Twenty-one patients contributing with 26 jaws were finally included in the analysis', '25 patients requiring bilateral premolar extraction due to orthodontic reasons, one premolar, chosen at random']",[],"['larger space closure', 'buccal bone dehiscence', 'time-point, gender, jaw, craniofacial growth, gingival biotype, buccal bone dehiscence after extraction, space closure']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}]",[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0449562', 'cui_str': 'Biotype (attribute)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]",,0.157475,EM (p = 0.014) and larger space closure within the study period (p = 0.001) resulted in a significantly higher incidence of GC.,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Bertl', 'Affiliation': 'Department of Periodontology, Faculty of Odontology, University of Malmö, Malmö, Sweden.'}, {'ForeName': 'Hemma', 'Initials': 'H', 'LastName': 'Neuner', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Meran', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Bertl', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Reich', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nemec', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bruckmann', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stavropoulos', 'Affiliation': 'Department of Periodontology, Faculty of Odontology, University of Malmö, Malmö, Sweden.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Bantleon', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}]",Journal of periodontology,['10.1002/JPER.19-0376']
1131,31045329,"Effect of locally produced complementary foods on fat-free mass, linear growth, and iron status among Kenyan infants: A randomized controlled trial.","The impact of quality complementary food products on infant growth and body composition has not been adequately investigated. This study evaluated the effect on fat-free mass (FFM) accrual, linear growth, and iron status of locally produced complementary food products comparing to a standard product. In a randomized, double-blind trial, 499 infants at 6 months received nine monthly rations of (a) WinFood Classic (WFC) comprising germinated amaranth (71%), maize (10.4%), small fish (3%), and edible termites (10%); (b) WinFood Lite (WFL) comprising germinated amaranth (82.5%), maize (10.2%), and multimicronutrient premix; or (c) fortified corn-soy blend plus (CSB+). Primary outcomes were changes in FFM, length, and plasma ferritin and transferrin receptors (TfR). FFM was determined using deuterium dilution. Analysis was by intention to treat, based on available cases. Compared with CSB+, there were no differences in change from 6 to 15 months in FFM for WFC 0.0 kg (95% CI [-0.30, 0.29]) and WFL 0.03 kg (95% CI [-0.25, 0.32]) and length change for WFC -0.3 cm (95% CI [-0.9, 0.4]) and WFL -0.3 cm (95% CI [-0.9, 0.3]). TfR increased in WFC group 3.3 mg L -1  (95% CI [1.7, 4.9]) and WFL group 1.7 mg L -1  (95% CI [0.1, 3.4]) compared with CSB+. Compared with the increase in Hb in CSB+ group, there was a reduction in Hb in WFC of -0.9 g dl -1  (95% CI [-1.3, -0.5]) and a lower increase in WFL -0.4 g dl -1  (95% CI [-0.8, 0.0]). In conclusion, the tested WinFoods had the same effect on FFM and length as CSB+, whereas Hb and iron status decreased, suggesting inhibited iron bioavailability from the amaranth-based WinFoods.",2019,TfR increased in WFC group,"['499 infants at 6\xa0months received', 'Kenyan infants']","['WFC', 'locally produced complementary foods', 'WinFood Lite (WFL', 'g\xa0dl -1', 'WFL', 'multimicronutrient premix; or (c) fortified corn-soy blend plus (CSB', 'nine monthly rations of (a) WinFood Classic (WFC']","['FFM and length as CSB', 'TfR', 'fat-free mass (FFM) accrual, linear growth, and iron status', 'FFM', 'length change for WFC', 'iron bioavailability', 'WFL', 'changes in FFM, length, and plasma ferritin and transferrin receptors (TfR', 'fat-free mass, linear growth, and iron status']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0034845', 'cui_str': 'Transferrin Receptor'}]",499.0,0.502662,TfR increased in WFC group,"[{'ForeName': 'Silvenus O', 'Initials': 'SO', 'LastName': 'Konyole', 'Affiliation': 'Department of Nutritional Sciences, Masinde Muliro University of Science and Technology, Kakamega, Kenya.'}, {'ForeName': 'Selina A', 'Initials': 'SA', 'LastName': 'Omollo', 'Affiliation': 'Institute of Tropical and Infectious Diseases, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Kinyuru', 'Affiliation': 'Department of Food Science and Technology, Jomo Kenyatta University of Agriculture and Technology, Juja, Kenya.'}, {'ForeName': 'Jutta K H', 'Initials': 'JKH', 'LastName': 'Skau', 'Affiliation': 'Department of Paediatrics, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Bethwell O', 'Initials': 'BO', 'LastName': 'Owuor', 'Affiliation': 'Biological Sciences Department, Kisii University, Kisii, Kenya.'}, {'ForeName': 'Benson B', 'Initials': 'BB', 'LastName': 'Estambale', 'Affiliation': 'Division of Research, Innovations and Outreach, Jaramogi Oginga Odinga University of Science and Technology, Bondo, Kenya.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Filteau', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Kim F', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Friis', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Roos', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Victor O', 'Initials': 'VO', 'LastName': 'Owino', 'Affiliation': 'Nutritional and Health Related Environmental Studies Section, International Atomic Energy Agency, Vienna, Austria.'}]",Maternal & child nutrition,['10.1111/mcn.12836']
1132,30975730,Patient activation intervention to facilitate participation in recovery after total knee replacement (MIME): a cluster randomised cross-over trial.,"BACKGROUND


Patient participation in care is a fundamental element of safe and high-quality healthcare with the potential to enhance health outcomes and improve patient satisfaction.
OBJECTIVES


To test the efficacy of a clinician-facilitated, bedside multimedia ( MyStay ) intervention designed to support patient participation in their recovery after total knee replacement surgery. The primary outcome was patients' reported worst pain intensity on postoperative day 3. Secondary outcomes were patient activation, length of hospital stay, knee function and satisfaction with care.
METHODS


Unmasked, cluster randomised, four-period cross-over trial with a simultaneous process evaluation within in a large private, not-for-profit, metropolitan teaching hospital. Statistical analyses used linear mixed models with random effects for wards, cohorts within wards and patients within cohorts and fixed effects for treatment and period.
RESULTS


241 patients were recruited between March 2014 and June 2015. Patients were admitted to intervention (104) or control (137) clusters. Intervention group patients reported significantly lower mean pain intensity scores on postoperative day 3 (6.1 vs 7.1, 95% CI -1.94 to -0.08, p=0.04). The percentages of patients who reported severe pain (score ≥7) were 43.7% and 64.2% in the intervention and control groups, respectively (χ 2  9.89, p=0.002; generalised linear mixed model Wald test, p=0.05). Intervention group patients on average stayed in hospital one less day (5.3 vs 6.3, 95% CI 0.05 to 1.94, p=0.04), reported higher activation (45.1% vs 27.1% at level 4 activation) (p=0.04) and higher overall satisfaction with care (9.3 vs 8.6, 95% CI 1.09 to 0.219, p=0.01), and were more likely to refer family or friends to the health service (9.3 vs 8.7, 95% CI 1.07 to 0.13, p=0.02).
CONCLUSION


The clinician-facilitated,  MyStay  bedside multimedia intervention enhanced patients' activation and participation in their care after surgery; pain intensity and length of stay in hospital were reduced and patients were more satisfied with their care.
TRIAL REGISTRATION


ACTRN12614000340639 (http://www.anzctr.org.au/default.aspx).",2019,"The clinician-facilitated,  MyStay  bedside multimedia intervention enhanced patients' activation and participation in their care after surgery; pain intensity and length of stay in hospital were reduced and patients were more satisfied with their care.
","['Patients were admitted to intervention (104) or control (137) clusters', 'Unmasked, cluster randomised, four-period cross-over trial with a simultaneous process evaluation within in a large private, not-for-profit, metropolitan teaching hospital', 'total knee replacement surgery', '241 patients were recruited between March 2014 and June 2015']","['Patient activation intervention', 'clinician-facilitated, bedside multimedia ( MyStay ) intervention', 'total knee replacement (MIME']","['worst pain intensity', 'higher activation', 'patient activation, length of hospital stay, knee function and satisfaction with care', 'overall satisfaction with care', 'mean pain intensity scores', 'severe pain', 'refer family or friends to the health service']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}]",241.0,0.083458,"The clinician-facilitated,  MyStay  bedside multimedia intervention enhanced patients' activation and participation in their care after surgery; pain intensity and length of stay in hospital were reduced and patients were more satisfied with their care.
","[{'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'McDonall', 'Affiliation': 'Faculty of Health, School of Nursing and Midwifery, Centre for Quality and Safety Research, Deakin University, Geelong, Victoria, Australia jo.mcdonall@deakin.edu.au.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'de Steiger', 'Affiliation': 'Department of Surgery, Epworth Healthcare, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Reynolds', 'Affiliation': 'Faculty of Medicine Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Bernice', 'Initials': 'B', 'LastName': 'Redley', 'Affiliation': 'Faculty of Health, School of Nursing and Midwifery, Centre for Quality and Safety Research, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Livingston', 'Affiliation': 'Faculty of Health, School of Nursing and Midwifery, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Anastasia F', 'Initials': 'AF', 'LastName': 'Hutchinson', 'Affiliation': 'Faculty of Health, School of Nursing and Midwifery, Centre for Quality and Safety Research, Epworth Partnership, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Botti', 'Affiliation': 'Faculty of Health, School of Nursing and Midwifery, Centre for Quality and Safety Research, Epworth Partnership, Deakin University, Geelong, Victoria, Australia.'}]",BMJ quality & safety,['10.1136/bmjqs-2018-008975']
1133,31773734,A transdiagnostic sleep and circadian intervention for adolescents: six-month follow-up of a randomized controlled trial.,"BACKGROUND


This study examined the 6-month follow-up outcomes of the Transdiagnostic Sleep and Circadian Intervention (TranS-C), compared to Psychoeducation about sleep and health (PE).
METHODS


Adolescents (mean [SD] = 14.77 [1.84] years) with eveningness chronotype and ""at-risk"" in at least one of five health domains were randomized to receive TranS-C (n = 89) or PE (n = 87) at a university-based clinic. Primary outcomes were average weeknight total sleep time and bedtime calculated from sleep diary, a questionnaire measure of circadian preference, and composite risks in five health domains. Secondary outcomes were selected sleep diary indices, sleepiness, and self- and parent-reported sleep, parent-reported risks in five health domains.
RESULTS


Relative to PE, TranS-C showed treatment effects through 6-month follow-up on only one primary outcome; namely eveningness circadian preference. TranS-C also showed treatment effects on two sleep and circadian secondary outcomes, including the Pittsburgh Sleep Quality Index and sleep-diary measured weeknight-weekend discrepancy in wakeup time. TranS-C did not show treatment effects on self-report or parent-report composite risks in five health domains. PE showed benefit, relative to TranS-C, from posttreatment to 6-month follow-up for reducing parent-reported behavioral health risk (secondary outcome).
CONCLUSIONS


In at-risk adolescents, the evidence supports the TranS-C treatment effects over six months on improving sleep and circadian functioning on selected outcomes but not on reducing risk in five health domains.",2020,"RESULTS


Relative to PE, TranS-C showed treatment effects through 6-month follow-up on only one primary outcome; namely eveningness circadian preference.","['1.84]\xa0years) with eveningness chronotype and ""at-risk"" in at least one of five health domains', 'Adolescents (mean [SD]\xa0=\xa014.77', 'adolescents']","['transdiagnostic sleep and circadian intervention', 'Transdiagnostic Sleep and Circadian Intervention (TranS-C', 'TranS-C (n\xa0=\xa089) or PE']","['eveningness circadian preference', 'average weeknight total sleep time and bedtime calculated from sleep diary, a questionnaire measure of circadian preference, and composite risks in five health domains', 'selected sleep diary indices, sleepiness, and self- and parent-reported sleep, parent-reported risks in five health domains', 'Pittsburgh Sleep Quality Index and sleep-diary measured weeknight-weekend discrepancy in wakeup time']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}]",,0.0964836,"RESULTS


Relative to PE, TranS-C showed treatment effects through 6-month follow-up on only one primary outcome; namely eveningness circadian preference.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Psychology, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Dolsen', 'Affiliation': 'Department of Psychology, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Armando J', 'Initials': 'AJ', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychology, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Notsu', 'Affiliation': 'Department of Psychology, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychology, University of California, Berkeley, Berkeley, CA, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13154']
1134,31773885,Effect of the Geriatric Emergency Department Intervention on outcomes of care for residents of aged care facilities: A non-randomised trial.,"OBJECTIVE


As the population of Australia ages, EDs will experience an increasing frequency of presentations of older adults from residential aged care facilities (RACFs). These presentations are often complex and time consuming in the chaotic and potentially hazardous ED environment. The Geriatric Emergency Department Intervention (GEDI) model was developed to optimise the care of frail older adults, especially RACF residents, in the ED. The aim of the present study was to evaluate the effectiveness of the GEDI model on the primary outcomes of disposition (admission, discharge or death) and ED length of stay for residents of RACFs, presenting to an ED in regional Queensland, Australia.
METHODS


GEDI is a nurse-led, physician-championed, innovative model delivered by advanced practice nurses with expertise in gerontology. This quasi-experimental pragmatic study compared outcomes for RACF residents who presented to a regional Queensland ED during three time periods: pre-GEDI, interim GEDI and post-GEDI implementation of the GEDI model. Outcomes included disposition, ED length of stay, ED re-presentation and mortality.
RESULTS


A significant increase in the likelihood of discharge from ED (hazard ratio 1.15, 95% confidence interval 1.05-1.26) and reductions in ED length of stay (hazard ratio 1.49, 95% confidence interval 1.24-1.78) were evident for RACF residents following the implementation of the GEDI intervention. There were no differences in mortality, ED re-presentation or in-hospital length of stay between the three time periods.
CONCLUSION


There is a paucity of evidence to support the implementation of nurse-led teams in EDs designed to target older adults living in RACFs. The GEDI model was effective in reducing ED length of stay while increasing the likelihood of safe discharge for RACF residents.",2020,"There were no differences in mortality, ED re-presentation or in-hospital length of stay between the three time periods.
","['older adults from residential aged care facilities (RACFs', 'advanced practice nurses with expertise in gerontology', 'older adults living in RACFs', 'residents of aged care facilities', 'frail older adults, especially RACF residents, in the ED']",['Geriatric Emergency Department Intervention'],"['ED length of stay', 'disposition (admission, discharge or death) and ED length of stay for residents of RACFs, presenting to an ED in regional Queensland, Australia', 'mortality, ED re-presentation or in-hospital length of stay', 'disposition, ED length of stay, ED re-presentation and mortality', 'likelihood of discharge from ED']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse (occupation)'}, {'cui': 'C0205767', 'cui_str': 'Gerontology'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",,0.0469376,"There were no differences in mortality, ED re-presentation or in-hospital length of stay between the three time periods.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Marsden', 'Affiliation': 'Sunshine Coast Hospital and Health Service, Sunshine Coast University Hospital, Sunshine Coast Region, Queensland, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': 'Sunshine Coast Hospital and Health Service, Sunshine Coast University Hospital, Sunshine Coast Region, Queensland, Australia.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Wallis', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, University of Sunshine Coast, Sunshine Coast Region, Queensland, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Craswell', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, University of Sunshine Coast, Sunshine Coast Region, Queensland, Australia.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Broadbent', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, University of Sunshine Coast, Sunshine Coast Region, Queensland, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Barnett', 'Affiliation': 'AStat, Institute of Health and Biomedical Innovation and School of Public Health and Social Work, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Crilly', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Griffith, Queensland, Australia.'}]",Emergency medicine Australasia : EMA,['10.1111/1742-6723.13415']
1135,31914790,Predictors for Poor Linkage to Care Among Hospitalized Persons Living with HIV and Co-Occurring Substance Use Disorder.,"Persons living with HIV (PLWH) with substance use disorders (SUD) remain a population difficult to engage in HIV care. Project HOPE (Hospital Visits as an Opportunity for Prevention and Engagement), a randomized controlled trial testing patient navigation with/without contingency management for PLWH with SUD, aimed to address this disparity. PLWH with SUD who were out of care were recruited from 11 hospitals across the United States from 2012 to 2014. Baseline socioeconomic factors, medical mistrust scores, and perceived discrimination surveys were collected at enrollment and evaluated for effects on linkage to care at the 6-month follow-up assessment. Linkage to care (attending an outpatient visit for HIV care), early linkage to care (attending first visit within 30 days of enrollment), and engagement in care (two HIV visits within the 6-month period) were determined by medical record abstraction, supplemented by self-report. Among 801 participants enrolled in the study (mean age 45 years, 33% women, and 73% African American), those who did not complete high school and with severe food insecurity had lower odds of being linked to care at 6 months. Those with high levels of medical mistrust, recent drug use, and who did not complete high school had lower odds of early linkage to care. Early linkage was associated with higher odds of engagement at 6 months and was mitigated by both patient navigator interventions (all  p  < .05). Addressing social determinants of health is critical to correct the disparity seen in HIV outcomes among PLWH with SUD. Identifying factors that alter the effect of interventions could help identify patients who would benefit most.",2020,Early linkage was associated with higher odds of engagement at 6 months and was mitigated by both patient navigator interventions (all p<0.05).,"['Persons living with HIV (PLWH) with substance use disorders (SUD', 'Hospitalized Persons Living with HIV and Co-Occurring Substance Use Disorder', 'PLWH with SUD who were out of care were recruited from 11 hospitals across the U.S. from 2012-2014', '801 participants enrolled in the study (mean age 45 years, 33% women, and 73% African American), those who did not complete high school and with severe food insecurity had lower odds of being linked to care at 6 months']",[],"['Baseline socioeconomic factors, medical mistrust scores, and perceived discrimination surveys']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3494174', 'cui_str': 'Food Insecurity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C0037464', 'cui_str': 'Socioeconomic Factors'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",801.0,0.0338922,Early linkage was associated with higher odds of engagement at 6 months and was mitigated by both patient navigator interventions (all p<0.05).,"[{'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Summers', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Colasanti', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Armstrong', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Mamta K', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, UT Southwestern, Dallas, Texas, USA.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Jacobs', 'Affiliation': 'National Institute on Drug Abuse, Bethesda, Maryland, USA.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': 'Infectious Diseases Program, Grady Health System, Atlanta, Georgia, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Del Rio', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",AIDS research and human retroviruses,['10.1089/AID.2019.0153']
1136,31943257,"Effect of Food Intake and Body Position on the Pharmacokinetics of Swallowed APT-1011, a Fluticasone Orally Disintegrating Tablet, in Healthy Adult Volunteers.","Eosinophilic esophagitis is a common atopic disease of the esophagus. APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate under development for the treatment of eosinophilic esophagitis. The objective of this study was to evaluate the pharmacokinetics, safety, and tolerability of APT-1011 under fed or fasted conditions in the morning (am) or at bedtime (hs) in the supine position. The study was a randomized, single-dose, 3-way, crossover design in healthy adult volunteers. In each study period participants received 2 3-mg orally disintegrating APT-1011 tablets. Serial plasma samples were collected before dosing and up to 72 hours after each dose. Twenty-two participants completed the study. The fluticasone propionate peak concentration (C max  ) ranged from 5.97 to 200 pg/mL. Compared with am-fasted dosing, am-fed dosing was associated with a modestly higher C max  (∼21%) but lower net exposure (area under the concentration-time curve ∼56% difference) and shorter time to reach C max  (T max  ) (T max  fasted = 10 hours, fed = 5 hours). Dosing at hs resulted in an 18% and 32% decrease in C max  relative to am-fasted and am-fed conditions, respectively. Dosing at hs led to an exposure that was higher than am-fed but lower than am-fasted dosing. T max  with hs dosing (14 hours) was later than that with am dosing (T max  fasted = 10 hours, fed = 5 hours). Adverse events were mild. There is low systemic exposure of fluticasone propionate with APT-1011. The rate of absorption was increased with a high-fat meal but decreased with hs dosing, suggesting the potential for longer dwell times in the esophagus.",2020,"T max  with hs dosing (14 hours) was later than that with am dosing (T max  fasted = 10 hours, fed = 5 hours).","['healthy adult volunteers', 'Twenty-two participants completed the study', 'Healthy Adult Volunteers']","['Food Intake and Body Position', 'Fluticasone Orally Disintegrating Tablet', 'fluticasone propionate with APT-1011', '2 3-mg orally disintegrating APT-1011 tablets', 'APT-1011', 'fluticasone propionate']","['Eosinophilic esophagitis', 'rate of absorption', 'C max', 'eosinophilic esophagitis', 'shorter time to reach C max  (T max  ', 'pharmacokinetics, safety, and tolerability', 'fluticasone propionate peak concentration (C max  ', 'Serial plasma samples', 'Adverse events']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C0450317', 'cui_str': '1011'}]","[{'cui': 'C0341106', 'cui_str': 'Chronic Esophagitis, Eosinophilic'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",22.0,0.109182,"T max  with hs dosing (14 hours) was later than that with am dosing (T max  fasted = 10 hours, fed = 5 hours).","[{'ForeName': 'Gail M', 'Initials': 'GM', 'LastName': 'Comer', 'Affiliation': 'Adare Pharmaceuticals, Lawrence Township, New Jersey, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Bush', 'Affiliation': 'Nuventra Pharma Sciences, Durham, North Carolina, USA.'}, {'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Marino', 'Affiliation': 'Mark T. Marino, Consulting, LLC, Carlsbad, California, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1572']
1137,29540864,"A randomized, placebo-controlled trial of extended-release guanfacine in children with autism spectrum disorder and ADHD symptoms: an analysis of secondary outcome measures.","In a prior report, we showed that extended-release guanfacine (GEXR) is safe and effective for children with autism spectrum disorder (ASD) accompanied by ADHD symptoms. Here, we examine the impact of GEXR on oppositional behavior, anxiety, repetitive behavior, and sleep disturbance. Sixty-two subjects with ASD (53 boys, 9 girls; ages 5-14 years) were randomly assigned to GEXR (n = 30) or placebo (n = 32) for 8 weeks. Outcomes include the Home Situation Questionnaire-Modified for ASD (HSQ-ASD), Anxiety scale of the Child and Adolescent Symptom Inventory (CASI), Children's Yale-Brown Obsessive-Compulsive Scale-Modified for ASD (CYBOCS-ASD), and Children's Sleep Habits Questionnaire (CSHQ). A repeated measures linear mixed model was used to determine the effects of treatment group and time on HSQ scores. For other measures, change from baseline was evaluated with Analysis of Covariance (ANCOVA).After 8 weeks of treatment, parent ratings of oppositional behavior on the HSQ declined by 44% (per item mean from 3.4 to 1.9) in the GEXR group compared to 12% (from 3.3 to 2.9) for placebo (p = 0.004). Repetitive behavior on the CYBOCS-ASD showed a significantly greater decline in GEXR-treated participants compared to placebo (24% vs. <1%, p = 0.01). No group differences were observed on CASI Anxiety or CSHQ (p = 0.64 and 0.75, respectively). GEXR was effective in reducing oppositional behavior and, more modestly, repetitive behavior. GEXR was not superior to placebo for anxiety, though baseline anxiety ratings were low. GEXR did not significantly improve sleep habits. Future studies could focus on repetitive behavior or anxiety, symptoms with limited treatment options.",2018,"Repetitive behavior on the CYBOCS-ASD showed a significantly greater decline in GEXR-treated participants compared to placebo (24% vs. <1%, p = 0.01).","['children with autism spectrum disorder (ASD', 'children with autism spectrum disorder and ADHD symptoms', 'Sixty-two subjects with ASD (53 boys, 9 girls; ages 5-14 years']","['GEXR', 'guanfacine (GEXR', 'placebo', 'extended-release guanfacine']","['HSQ scores', 'CASI Anxiety or CSHQ', 'sleep habits', ""Home Situation Questionnaire-Modified for ASD (HSQ-ASD), Anxiety scale of the Child and Adolescent Symptom Inventory (CASI), Children's Yale-Brown Obsessive-Compulsive Scale-Modified for ASD (CYBOCS-ASD), and Children's Sleep Habits Questionnaire (CSHQ"", 'oppositional behavior', 'oppositional behavior, anxiety, repetitive behavior, and sleep disturbance', 'Repetitive behavior on the CYBOCS-ASD', 'parent ratings of oppositional behavior on the HSQ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",62.0,0.137188,"Repetitive behavior on the CYBOCS-ASD showed a significantly greater decline in GEXR-treated participants compared to placebo (24% vs. <1%, p = 0.01).","[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Politte', 'Affiliation': 'Department of Psychiatry, Carolina Institute for Developmental Disabilities, University of North Carolina School of Medicine, 101 Renee Lynne Court, Carrboro, NC, 27510, USA. laura.politte@cidd.unc.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Scahill', 'Affiliation': 'Department of Pediatrics, Marcus Autism Center, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Figueroa', 'Affiliation': 'Department of Pediatrics, Pediatrics Biostatistics Core, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'McCracken', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry, UCSF Weill Institute for Neurosciences, University of California, San Francisco School of Medicine, San Francisco, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'McDougle', 'Affiliation': 'Department of Psychiatry, Lurie Center for Autism, Harvard Medical School, Boston, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-018-0039-3']
1138,31848050,"Corrigendum to ""Safety, immunogenicity and lot-to-lot consistency of a new Bivalent Oral Polio Vaccine (bOPV) in healthy Infants: Results of a Phase III, observer blind, randomized, controlled clinical study"" [Vaccine 37 (2019) 4275-4280].",,2020,,"['37 (2019) 4275-4280', 'healthy Infants']","['Vaccine', 'new Bivalent Oral Polio Vaccine (bOPV']",[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}]",[],,0.0700865,,"[{'ForeName': 'Khalequ', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh. Electronic address: kzaman@icddrb.org.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kingma', 'Affiliation': 'Bilthoven Biologicals, Bilthoven, Netherlands.'}, {'ForeName': 'Md', 'Initials': 'M', 'LastName': 'Yunus', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Ineke', 'Initials': 'I', 'LastName': 'van Straaten', 'Affiliation': 'Bilthoven Biologicals, Bilthoven, Netherlands.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Mekkes', 'Affiliation': 'Bilthoven Biologicals, Bilthoven, Netherlands.'}, {'ForeName': 'Xandra', 'Initials': 'X', 'LastName': 'Bouwstra', 'Affiliation': 'Bilthoven Biologicals, Bilthoven, Netherlands.'}, {'ForeName': 'Bhagwat', 'Initials': 'B', 'LastName': 'Gunale', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Prasad S', 'Initials': 'PS', 'LastName': 'Kulkarni', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}]",Vaccine,['10.1016/j.vaccine.2019.12.006']
1139,31415482,"An Educational Intervention for Acute Dizziness Care: A Randomized, Vignette-based Study.","IMPORTANCE


Benign paroxysmal positional vertigo (BPPV) is a common cause of acute dizziness. Strong evidence exists for diagnosing BPPV using the Dix-Hallpike Test (DHT) and treating it with the canalith repositioning maneuver (CRM). Despite this, both are infrequently used in the emergency department (ED).
OBJECTIVE


As an early method to evaluate a BPPV-focused educational intervention, we evaluated whether an educational intervention improved ED provider performance on hypothetical stroke and BPPV cases delivered by vignette.
DESIGN


A randomized, controlled, educational intervention study in ED physicians. The intervention aimed to promote the appropriate use of the DHT and CRM. A BPPV vignette, a stroke-dizziness (safety) vignette, and vignette scoring schemes (higher scores indicating more optimal care) used previously established vignette methodology.
SETTING


We recruited participants at the exhibitor hall of an emergency medicine annual meeting.
PARTICIPANTS


We recruited 48 emergency physicians. All were board certified or residency trained and board eligible. All were engaged in the active practice of emergency medicine. None were trainees.
INTERVENTIONS


Intervention group: a narrated, educational presentation by computer followed by the clinical vignettes.
CONTROL GROUP


Received no educational intervention and completed the clinical vignettes-intended to mirror current clinician practice.
MAIN OUTCOME MEASURE


Primary endpoint: total score (out of 200 points) on a vignette-based scoring instrument assessing the performance of history, physical, and diagnostic testing on hypothetical stroke and BPPV cases.
RESULTS


The efficacy threshold was crossed at the interim analysis. The intervention group had higher performance scores compared with controls (113.2 versus 68.6, p < 0.00001). BPPV and safety subscores were both significantly higher in the intervention group. Sixty-two percent of the intervention group planned to use the DHT versus 29% of controls. After the vignette described characteristic BPPV nystagmus, 100% of the intervention group planned to use the CRM versus 17% of controls.
CONCLUSIONS AND RELEVANCE


The educational intervention increased provider performance in dizziness vignettes, including more frequent appropriate use of the DHT/CRM. These findings indicate the intervention positively influenced planned behavior. Future work is needed to implement and evaluate this intervention in clinical practice.",2019,"The intervention group had higher performance scores compared with controls (113.2 versus 68.6, p < 0.00001).","['participants at the exhibitor hall of an emergency medicine annual meeting', 'Acute Dizziness Care', 'Benign paroxysmal positional vertigo (BPPV', 'We recruited 48 emergency physicians', 'ED physicians']","['GROUP', 'no educational intervention', 'educational intervention improved ED provider performance', 'DHT', 'CRM', 'Educational Intervention', 'Intervention group: a narrated, educational presentation by computer followed by the clinical vignettes', 'educational intervention']","['total score (out of 200 points) on a vignette-based scoring instrument assessing the performance of history, physical, and diagnostic testing on hypothetical stroke and BPPV cases', 'BPPV and safety subscores', 'higher performance scores', 'planned behavior', 'provider performance in dizziness vignettes', 'characteristic BPPV nystagmus']","[{'cui': 'C2356088', 'cui_str': 'Halls'}, {'cui': 'C0013964', 'cui_str': 'Emergency Medicine'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus, Pathologic'}]",48.0,0.0655215,"The intervention group had higher performance scores compared with controls (113.2 versus 68.6, p < 0.00001).","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Meurer', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Tsodikov', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Brigid', 'Initials': 'B', 'LastName': 'Rowell', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fagerlin', 'Affiliation': 'Department of Population Health Sciences, University of Utah.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Telian', 'Affiliation': 'Department of Otolaryngology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Damschroder', 'Affiliation': 'Implementation Pathways, LLC.'}, {'ForeName': 'Lawrence C', 'Initials': 'LC', 'LastName': 'An', 'Affiliation': 'Department of Internal Medicine.'}, {'ForeName': 'Lewis B', 'Initials': 'LB', 'LastName': 'Morgenstern', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Kerber', 'Affiliation': 'Department of Neurology.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002338']
1140,31843638,Methods and rationale to assess the efficacy of a parenting intervention targeting diet improvement and substance use prevention among Latinx adolescents.,"Latinx adolescents are at higher risk for chronic diseases relative to adolescents of other ethnic groups, in part because of their lack of adherence to diet recommendations and their higher rates of substance use. Given the proximal influence of family factors during the developmental stage of adolescence, parenting interventions may be an effective way to promote healthy nutrition and substance use prevention simultaneously. This article describes the design and theoretical rationale of a study assessing the effects of Families Preparing the New Generation Plus (FPNG Plus), a 10-week culturally-tailored nutrition and substance use prevention parenting program, on diet and substance use outcomes among Latinx middle school students (6th-8th grade). The 3-arm cluster randomized controlled trial compares FPNG Plus (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and a comparison condition (focusing on academic success) in 1494 parent-child dyads from 18 schools, randomized at the school level. Adolescents and parents will complete surveys pre- and post-intervention, and 16-weeks after program participation, regarding diet behaviors, substance use, and parenting practices. A random subsample of 126 dyads (42 from each program), will participate in additional data collection to assess the home food environment, detailed dietary intake (via two 24-h recalls), and provide biomarkers of cardiometabolic risk (blood pressure, total cholesterol and HbA1c). If successful, this study will provide evidence contributing to helping Latinx parents assist their adolescent children develop and maintain long-lasting positive lifestyle behaviors in order to prevent concurrent substance use and diet-related chronic diseases.",2020,"The 3-arm cluster randomized controlled trial compares FPNG Plus (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and a comparison condition (focusing on academic success) in 1494 parent-child dyads from 18 schools, randomized at the school level.","['Latinx adolescents', 'Latinx middle school students (6th-8th grade', 'A random subsample of 126 dyads (42 from each program', '1494 parent-child dyads from 18 schools, randomized at the school level']","['parenting intervention', 'FPNG Plus (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and a comparison condition (focusing on academic success']","['cardiometabolic risk (blood pressure, total cholesterol and HbA1c']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0150358', 'cui_str': 'Substance use prevention (procedure)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0700132', 'cui_str': 'Academic Success'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",126.0,0.0486669,"The 3-arm cluster randomized controlled trial compares FPNG Plus (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and a comparison condition (focusing on academic success) in 1494 parent-child dyads from 18 schools, randomized at the school level.","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vega-López', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, United States of America; Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America. Electronic address: Sonia.Vega.Lopez@asu.edu.'}, {'ForeName': 'Flavio F', 'Initials': 'FF', 'LastName': 'Marsiglia', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Ayers', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Lela Rankin', 'Initials': 'LR', 'LastName': 'Williams', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Bruening', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Anaid', 'Initials': 'A', 'LastName': 'Gonzalvez', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Vega-Luna', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Perilla', 'Affiliation': 'American Dream Academy, Arizona State University, 542 E. Monroe Street, Suite D-100, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Harthun', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Gabriel Q', 'Initials': 'GQ', 'LastName': 'Shaibi', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America; College of Nursing and Health Innovation, Arizona State University, 500 North 3rd Street, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Delgado', 'Affiliation': 'American Dream Academy, Arizona State University, 542 E. Monroe Street, Suite D-100, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rosario', 'Affiliation': 'American Dream Academy, Arizona State University, 542 E. Monroe Street, Suite D-100, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Hartmann', 'Affiliation': 'College of Nursing and Health Innovation, Arizona State University, 500 North 3rd Street, Phoenix, AZ 85004, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105914']
1141,31889791,"Efficacy of combined medication of nifedipine and magnesium sulfate on gestational hypertension and the effect on PAPP-A, VEGF, NO, Hcy and vWF.","Objective


To investigate the effects of combined medication of nifedipine and magnesium sulfate on the blood pressure, pregnancy-associated plasma protein A (PAPP-A), vascular endothelial growth factor (VEGF), nitric oxide (NO), homocysteine (Hcy) and von Willebrand factor (vWF) in gestational hypertension patients.
Methods


A total of 220 gestational hypertension patients were enrolled as the subjects, and divided into two groups randomly, i.e. the observation group and the control group. In observation group, patients took combined medication of nifedipine and magnesium sulfate, while those in the control group only took magnesium sulfate for treatment. Clinical efficacy, and the changes in blood pressure, PAPP-A, VEGF, NO, Hcy and vWF before and after treatment were compared between two groups.
Results


In the observation group and the control group, total effectiveness rates were 92.7% and 70.9%, respectively ( p <  0.05). After treatment, we found significant decreases in PAPP-A, VEGF, NO, Hcy and vWF in patients of two groups, with more significant decreases in the observation group ( p <  0.05). Incidence rates of the adverse reactions in two groups were 5.5% and 6.4%, respectively, without any statistically significant differences ( p >  0.05). In the observation group, patients had fewer complications ( p <  0.05).
Conclusion


Combined medication of magnesium sulfate and nifedipine can decrease the levels of PAPP-A, VEGF, NO, Hcy and vWF in serum as well as the blood pressure of patients with gestational hypertension, with a reduction in incidence rate of complications and improvement in efficacy.",2019,"In the observation group, patients had fewer complications ( p <  0.05).
","['patients with gestational hypertension', '220 gestational hypertension patients', 'gestational hypertension patients']","['nifedipine and magnesium sulfate', 'magnesium sulfate and nifedipine', 'magnesium sulfate']","['blood pressure, PAPP-A, VEGF, NO, Hcy and vWF', 'blood pressure, pregnancy-associated plasma protein A (PAPP-A), vascular endothelial growth factor (VEGF), nitric oxide (NO), homocysteine (Hcy) and von Willebrand factor (vWF', 'gestational hypertension', 'PAPP-A, VEGF, NO, Hcy and vWF', 'total effectiveness rates', 'Incidence rates of the adverse reactions', 'levels of PAPP-A, VEGF, NO, Hcy and vWF in serum', 'complications', 'blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0852036', 'cui_str': 'Hypertension, Pregnancy-Induced'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0032999', 'cui_str': 'Pregnancy-Associated Plasma Protein-A'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0852036', 'cui_str': 'Hypertension, Pregnancy-Induced'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",220.0,0.0253347,"In the observation group, patients had fewer complications ( p <  0.05).
","[{'ForeName': 'Yaohan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Cardio-Pulmonary Function, Henan Provincial People's Hospital Heart Centre (Fuwai Central China Cardiovascular Hospital), Zhengzhou 45000, China.""}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardio-Pulmonary Function, Henan Provincial People's Hospital Heart Centre (Fuwai Central China Cardiovascular Hospital), Zhengzhou 45000, China.""}, {'ForeName': 'Yaqi', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Cardio-Pulmonary Function, Henan Provincial People's Hospital Heart Centre (Fuwai Central China Cardiovascular Hospital), Zhengzhou 45000, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yan', 'Affiliation': ""Department of Cardio-Pulmonary Function, Henan Provincial People's Hospital Heart Centre (Fuwai Central China Cardiovascular Hospital), Zhengzhou 45000, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': ""Department of Cardio-Pulmonary Function, Henan Provincial People's Hospital Heart Centre (Fuwai Central China Cardiovascular Hospital), Zhengzhou 45000, China.""}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2019.08.012']
1142,31100199,"The effect of intradialytic exercise twice a week on the physical capacity, inflammation, and nutritional status of dialysis patients: A randomized controlled trial.","INTRODUCTION


Inactivity, uremia, and malnutrition in dialysis patients may lead to decreased muscle mass and physical capacity. As a preventative measure, dialysis patients are provided with an intradialytic exercise program. Our study aimed to determine the role of intradialytic exercise performed 2 times per week on physical capacity, inflammation, and nutritional status in dialysis patients and to determine which exercises are more suitable for this population.
METHODS


A randomized clinical trial in which participants were randomly assigned to 1 of 3 groups, i.e., a group of patients performing aerobic exercise, a group of patients performing a combination of aerobic and resistance exercise and the control group. The study was conducted at the Dialysis Unit of Dr. Cipto Mangunkusumo General Hospital, Jakarta for 12 weeks from February to May 2018. The inclusion criteria were dialysis patients aged over 18 years who had undergone routine dialysis for over 3 months.
FINDINGS


A total of one hundred twenty patients were included in the study. There was a significant increase in lower extremity strength in the group performing aerobic exercise and in the combined exercise group compared to the lower extremity strength of the control group. There was also a significant increase in the physical component score (PCS) of the KDQOL-SF™ instrument in the aerobic training and combination exercise groups compared to the PCS of the control group. No significant differences were found between the combination exercise group and the aerobic training group in any outcome.
DISCUSSION


Both types of exercise programs significantly increased the lower extremity muscle strength and the PCS of the quality of life index. Combination exercise was not more effective than aerobic exercise for dialysis patients.",2019,There was a significant increase in lower extremity strength in the group performing aerobic exercise and in the combined exercise group compared to the lower extremity strength of the control group.,"['dialysis patients aged over 18\u2009years who had undergone routine dialysis for over 3\u2009months', 'Dialysis Unit of Dr. Cipto Mangunkusumo General Hospital, Jakarta for 12\u2009weeks from February to May 2018', 'dialysis patients', 'A total of one hundred twenty patients were included in the study']","['aerobic training', 'aerobic exercise, a group of patients performing a combination of aerobic and resistance exercise and the control group', 'intradialytic exercise', 'intradialytic exercise program', 'aerobic exercise', 'Combination exercise']","['physical capacity, inflammation, and nutritional status', 'lower extremity strength', 'physical component score (PCS', 'lower extremity muscle strength and the PCS of the quality of life index', 'extremity strength']","[{'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1629858', 'cui_str': 'Dialysis unit'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}]",120.0,0.0305706,There was a significant increase in lower extremity strength in the group performing aerobic exercise and in the combined exercise group compared to the lower extremity strength of the control group.,"[{'ForeName': '', 'Initials': '', 'LastName': 'Suhardjono', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine Universitas Indonesia/Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Vidhia', 'Initials': 'V', 'LastName': 'Umami', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine Universitas Indonesia/Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Deddy', 'Initials': 'D', 'LastName': 'Tedjasukmana', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Indonesia/Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Siti', 'Initials': 'S', 'LastName': 'Setiati', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine Universitas Indonesia/Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12764']
1143,31793099,Distraction-based relief of pain associated with peripheral intravenous catheterisation in adults: a randomised controlled trial.,"AIMS AND OBJECTIVES


This study aimed to determine the effect of methods of distraction to relieve pain associated with the peripheral intravenous catheter (PIC) insertion procedure, thus improving patient satisfaction. Specifically, we examined such effect by playing 3D videos with virtual reality goggles and showing pictures to the patient containing distractive optical illusions.
BACKGROUND


In the literature, although the efficacy of various pharmacological methods for reducing pain associated with the insertion of PIC has been evaluated in adults, studies on nonpharmacological methods are limited.
METHODS


The research was conducted with a randomised controlled single-blind experimental study. The sample consisted of 120 patients. While nothing is applied to the control group, cards containing distractive optical illusion pictures and playing 3D videos with VR goggles during PIC insertion is applied for distraction groups. The data collection form consisted of items that measured the sociodemographic characteristics of the patients and a visual analog scale. The CONSORT checklist was followed in reporting this study. This study is registered with ClinicalTrials.gov. No. NCT03945929.
RESULTS


The mean pain level was 4.72 ± 3.15 in the control group and 3.41 ± 2.81 in the distraction groups and the difference was found to be statistically significant (p = .02). When the mean satisfaction level between the groups was compared, it was found to be 5.12 ± 3.41 in the control group and 8.07 ± 2.67 in the groups undergoing distraction methods. The difference between them was statistically significant (p = .01).
CONCLUSIONS


This study found that the use of cards containing distractive optical illusion pictures and playing 3D videos with VR goggles during PIC insertion in adult patients were both effective.
RELEVANCE TO CLINICAL PRACTICE


These distraction methods may be used to reduce pain due to PIC insertion in nonurgent and less urgent adult patients in the emergency department.",2020,"When the mean satisfaction level between the groups was compared, it was found to be 5.12 ± 3.41 in the control group and 8.07 ± 2.67 in the groups undergoing distraction methods.","['Adults', '120 patients', 'adult patients']","['cards containing distractive optical illusion pictures and playing 3D videos with VR goggles', 'Peripheral Intravenous Catheterization', 'peripheral intravenous catheter (PIC) insertion procedure', 'playing 3D videos with virtual reality goggles and showing pictures to the patient containing distractive optical illusions']","['mean pain level', 'mean satisfaction level']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0029139', 'cui_str': 'Optical Illusions'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0018020', 'cui_str': 'Goggles'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter, device (physical object)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",120.0,0.0790317,"When the mean satisfaction level between the groups was compared, it was found to be 5.12 ± 3.41 in the control group and 8.07 ± 2.67 in the groups undergoing distraction methods.","[{'ForeName': 'Tulay', 'Initials': 'T', 'LastName': 'Basak', 'Affiliation': 'Gulhane Faculty of Nursing, Fundamentals of Nursing Department, University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Senem', 'Initials': 'S', 'LastName': 'Duman', 'Affiliation': 'Gulhane Faculty of Nursing, Fundamentals of Nursing Department, University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Ayla', 'Initials': 'A', 'LastName': 'Demirtas', 'Affiliation': 'Gulhane Faculty of Nursing, Fundamentals of Nursing Department, University of Health Sciences, Ankara, Turkey.'}]",Journal of clinical nursing,['10.1111/jocn.15131']
1144,31553517,Stage I hypertension is associated with impaired systolic function by strain imaging compared with prehypertension: A report from the prever study.,"High blood pressure (BP) is associated with higher rates of cardiovascular events, even in stage I hypertension (HTN) and prehypertension (preHTN). Lower left ventricular (LV) systolic function, assessed by global longitudinal strain (GLS), has been demonstrated in individuals with HTN compared to individuals with normal BP, but a comparison of individuals with preHTN and stage I HTN was not described to date. The PREVER study includes two randomized double-blind controlled trials, performed in volunteers with preHTN (PREVER-prevention trial) or stage I HTN (PREVER-treatment trial), aged 30-70 years. A subsample of patients of both trials had GLS measured from 2D echocardiograms performed at baseline and after 18 months of follow-up. We compared baseline data from both studies and, among stage I HTN patients, clinical and echocardiographic correlates of GLS were determined. Participants with preHTN (n = 91;53% female; 55 ± 9 yo) and stage I HTN (n = 105; 44% female; 55 ± 8 yo) had similar clinical parameters beyond the expected differences in BP levels. Participants with stage I HTN had lower GLS (-17.5 ± 2.5% vs -18.2 ± 2.4%, P = .03) compared with those with preHTN. In stage I HTN, lower GLS was associated with lower e' and lower LV ejection fraction. In conclusion, patients in Stage I HTN may already express changes in GLS compared with individuals with preHTN, suggesting that even mildly difference in BP can be impact in subclinical systolic function.",2019,"Participants with stage I HTN had lower GLS (-17.5 ± 2.5% vs -18.2 ± 2.4%, P = .03) compared with those with preHTN.","['patients in Stage', 'aged 30-70\xa0years', 'Participants with preHTN (n\xa0=\xa091;53% female; 55\xa0±\xa09\xa0yo) and stage I HTN (n\xa0=\xa0105; 44% female; 55\xa0±\xa08\xa0yo', 'volunteers with preHTN (PREVER-prevention trial) or stage']",['strain imaging compared with prehypertension'],"['BP levels', 'lower GLS', 'LV ejection fraction', 'Lower left ventricular (LV) systolic function, assessed by global longitudinal strain (GLS', 'High blood pressure (BP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C1696708', 'cui_str': 'Pre-Hypertension'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}]",,0.306836,"Participants with stage I HTN had lower GLS (-17.5 ± 2.5% vs -18.2 ± 2.4%, P = .03) compared with those with preHTN.","[{'ForeName': 'Angela B S', 'Initials': 'ABS', 'LastName': 'Santos', 'Affiliation': 'Division of Cardiology, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Murilo', 'Initials': 'M', 'LastName': 'Foppa', 'Affiliation': 'Division of Cardiology, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Bertoluci', 'Affiliation': 'Division of Cardiology, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Thais V', 'Initials': 'TV', 'LastName': 'Branchi', 'Affiliation': 'Division of Cardiology, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Sandra C', 'Initials': 'SC', 'LastName': 'Fuchs', 'Affiliation': 'Postgraduate Studies Program in Cardiology, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Flávio D', 'Initials': 'FD', 'LastName': 'Fuchs', 'Affiliation': 'Division of Cardiology, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13695']
1145,31482633,"The effect of Zanthoxylum bungeanum maxim extract on crow's feet: A double-blind, split-face trial.","As one of the most obvious signs of aging, wrinkles have long been the concern of many people and continue to be a major topic in dermal-cosmetic industry. Accordingly, there is a need to develop products with good efficacy and safety profile. The Zanthoxylum bungeanum maxim (ZBM) extract is a natural food which may possess the property of a toxin-like botulinum. To evaluate the efficacy and safety of a formulation that contains 2% ZBM pericarp extract in the treatment of wrinkles. Twenty females aged 35-60 years old were enrolled in this randomized, vehicle-controlled, double-blind, and split-face trial. The trial lasted for 30 days, when participants randomly used formulations containing 2% ZBM extract on one side of the temporal canthus and vehicle formulation on the other side. Skin roughness, skin hydration, and skin elasticity were evaluated by Primospico, Corneometer® CM825, and Cutometer® MPA580, respectively. The formulation containing 2% ZBM extract has a significant short-term anti-crow's feet effect compared with vehicle. No adverse effect was shown during the study. Topical application of 2% ZBM extract is tolerable and can be used as an effective cosmetic agent for short-term wrinkle treatment.",2019,The formulation containing 2% ZBM extract has a significant short-term anti-crow's feet effect compared with vehicle.,"['20 females aged 35 to 60\u2009years old', ""crow's feet""]","['Zanthoxylum bungeanum Maxim extract', 'ZBM extract']","['Skin roughness, skin hydration and skin elasticity', 'adverse effect', 'efficacy and safety']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet (finding)""}]","[{'cui': 'C1026724', 'cui_str': 'Zanthoxylum'}, {'cui': 'C0024968', 'cui_str': 'Maxims'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0423761', 'cui_str': 'Skin elasticity (observable entity)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0929858,The formulation containing 2% ZBM extract has a significant short-term anti-crow's feet effect compared with vehicle.,"[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, China.'}]",Dermatologic therapy,['10.1111/dth.13079']
1146,31885484,The clinical efficacy study of treatment to Chiari malformation type I with syringomyelia under the minimally invasive surgery of resection of Submeningeal cerebellar Tonsillar Herniation and reconstruction of Cisterna magna.,"Purpose


Discuss the clinical efficacy of treatment to Chiari malformation type I with syringomyelia under the minimally invasive surgery of resection of Submeningeal Cerebellar Tonsillar Herniation and reconstruction of Cisterna magna.
Methods


130 Chiari malformation type I with syringomyelia patients, divided into treatment group, literature group and control group, were collected to be treated under the monitoring of ultrasound in the surgery.
Results


6 months after operation, the lesions were decreased or disappeared, the symptoms were relieved obviously. According to MRI and Mimics 17.0 software, the volumes of Cisterna magna increased distinctly ( P  < 0.001), the proportions of brain in foramen magnum region were decreased ( P  < 0.001). Assessed by CCOS scale and Tator methods, the improvement rates of treatment group were 97.7% and 94.6%, the literature group and control group were 82.2% and 77.8%, respectively.
Conclusion


The efficacy of Chiari malformation type I with syringomyelia under the minimally invasive surgery of resection of Submeningeal Cerebellar Tonsillar Herniation and reconstruction of Cisterna magna is remarkable, and the complications are fewer. This surgery emphasizes recovery of tonsil of cerebellum and reconstruction of Cisterna magna and the circulation path of cerebrospinal fluid, which is a safe and efficient treatment.",2019,"According to MRI and Mimics 17.0 software, the volumes of Cisterna magna increased distinctly ( P  < 0.001), the proportions of brain in foramen magnum region were decreased ( P  < 0.001).","['I with syringomyelia under the minimally invasive surgery of resection of Submeningeal cerebellar Tonsillar Herniation and reconstruction of Cisterna magna', '130 Chiari malformation type']",['Chiari malformation type'],"['CCOS scale and Tator methods, the improvement rates', 'proportions of brain in foramen magnum region', 'volumes of Cisterna magna']","[{'cui': 'C0039144', 'cui_str': 'Syringomyelus'}, {'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0393983', 'cui_str': 'Cerebellar Herniation'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0008841', 'cui_str': 'Cisterna Magna'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0003803', 'cui_str': 'Arnold-Chiari Deformity'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0003803', 'cui_str': 'Arnold-Chiari Deformity'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0222045'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0016519', 'cui_str': 'Foramen Magnum'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0008841', 'cui_str': 'Cisterna Magna'}]",,0.0210633,"According to MRI and Mimics 17.0 software, the volumes of Cisterna magna increased distinctly ( P  < 0.001), the proportions of brain in foramen magnum region were decreased ( P  < 0.001).","[{'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'Department of Neurospinal Surgery, The Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou 450000, China.'}, {'ForeName': 'Jichao', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Neurospinal Surgery, The Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou 450000, China.'}, {'ForeName': 'Liuxiang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurospinal Surgery, The Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou 450000, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Neurospinal Surgery, The Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou 450000, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xin', 'Affiliation': 'Department of Neurospinal Surgery, The Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou 450000, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurospinal Surgery, Yuquan Hospital of Tsinghua University, Beijing 10000, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2019.07.012']
1147,31885486,Modulation of human visuospatial attention analysis by transcranial direct current stimulation (tDCS) in the line bisection performance.,"The general population shows physiologic biases in the line bisection performance for visuospatial attention, almost to the left known as pseudoneglect. Previous studies have shown that tDCS affects visuospatial attention in line bisection. This research applies tDCS over left posterior parietal cortice (P3) or right posterior parietal cortice (P4) to explore the effect on pseudoneglect. Subjects randomly were divided into five groups by stimulation distribution: (i) P3-anodal (P3A), (ii) P3-cathodal (P3C), (iii) P4-anodal (P4A), (iv) P4-cathodal (P4C), (v) sham. Participants respectively finished the post-tDCS line-bisection assignment (lines on the left/right side of the monitor (LL/LR), and lines in the center of the monitor (LC)) the same as the pre-tDCS task over the session (P3A, P3C, P4A, P4C and sham) tDCS condition. The principal findings were that P3A tDCS reduced the leftward shift in the horizontal line bisection task, as well as P4C tDCS reduced the leftward shift in LL. Sham stimulation as well as P3C and P4A stimulation didn't have systematic improvements in the line bisection tasks. Therefore, an activation-orientation model of pseudoneglect is corroborated by these findings. Activation of intact structures in the rebalance of left and right parietal cortex might impose modulating effects on tDCS.",2019,Sham stimulation as well as P3C and P4A stimulation didn't have systematic improvements in the line bisection tasks.,[],"['stimulation distribution: (i) P3-anodal (P3A), (ii) P3-cathodal (P3C), (iii) P4-anodal (P4A), (iv) P4-cathodal (P4C), (v) sham', 'transcranial direct current stimulation (tDCS', 'tDCS']",[],[],"[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]",[],,0.0185278,Sham stimulation as well as P3C and P4A stimulation didn't have systematic improvements in the line bisection tasks.,"[{'ForeName': 'Aijuan', 'Initials': 'A', 'LastName': 'Ni', 'Affiliation': 'Institute of Medical Support Technology, Academy of Military Sciences, Tianjin 300161, China.'}, {'ForeName': 'Rongchao', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin 300120, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Tian', 'Affiliation': 'Institute of Medical Support Technology, Academy of Military Sciences, Tianjin 300161, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2019.06.007']
1148,31721430,Impact of high on-treatment platelet reactivity on outcomes following PCI in patients on hemodialysis: An ADAPT-DES substudy.,"OBJECTIVES


We sought to compare clinical outcomes after percutaneous coronary intervention (PCI) in patients on versus not on hemodialysis (HD) and examine whether high on-treatment platelet reactivity (HPR) further impacts outcomes among patients on HD.
BACKGROUND


Both chronic kidney disease (CKD) and HPR are predictors of major adverse cardiac events (MACE) after PCI.
METHODS


Two-year outcomes of patients from the prospective, multicenter ADAPT-DES study (N = 8,582) were analyzed according to HD status at enrollment. All patients underwent platelet function testing with the VerifyNow assay; HPR on clopidogrel was defined as P2Y12 reaction units (PRU) >208.
RESULTS


Compared with non-HD patients, patients on HD (n = 85) had significantly higher baseline PRU (median 254 vs. 188, p = .001) and more frequently had HPR (61.7% vs. 42.5%, p < .001). HD was associated with increased 2-year rates of MACE (death, myocardial infarction (MI) or definite stent thrombosis (ST); 23.4% vs. 10.7%, p < .001). HD was also strongly associated with 2-year overall mortality, cardiac death, MI, target vessel revascularization, major bleeding, stroke and ST. Following adjustment for HPR and other covariates, HD was independently associated with overall mortality, MI, ST, and major bleeding at 2 years. The relationship between HD status and 2-year MACE was consistent in patients with and without HPR (P interaction  = .78).
CONCLUSIONS


Nearly two-thirds of patients on HD exhibited HPR on clopidogrel, and both HD and HPR were independently associated with 2-year adverse outcomes after DES implantation. However, the deleterious impact of HD on clinical outcomes was present in both patients with and without HPR.",2019,"HD was associated with increased 2-year rates of MACE (death, myocardial infarction (MI) or definite stent thrombosis (ST); 23.4% vs. 10.7%, p < .001).","['patients on versus not on hemodialysis (HD', 'patients on hemodialysis', 'patients on HD', 'patients with and without HPR']","['PCI', 'percutaneous coronary intervention (PCI']","['baseline PRU', 'HPR', '2-year rates of MACE (death, myocardial infarction (MI) or definite stent thrombosis (ST', 'HD status and 2-year MACE', '2-year overall mortality, cardiac death, MI, target vessel revascularization, major bleeding, stroke and ST', 'overall mortality, MI, ST, and major bleeding', '2-year adverse outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",,0.0289423,"HD was associated with increased 2-year rates of MACE (death, myocardial infarction (MI) or definite stent thrombosis (ST); 23.4% vs. 10.7%, p < .001).","[{'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Rubin', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Giora', 'Initials': 'G', 'LastName': 'Weisz', 'Affiliation': 'Clinical Trails Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Clinical Trails Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Stuckey', 'Affiliation': 'LeBauer-Brodie Center for Cardiovascular Research and Education/Cone Health, Greensboro, North Carolina.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Witzenbichler', 'Affiliation': 'Helios Amper-Klinikum, Dachau, Germany.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rinaldi', 'Affiliation': 'Sanger Heart and Vascular Institute/Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Heart Center, University of Freiburg, Bad Krozingen, Germany.'}, {'ForeName': 'D Christopher', 'Initials': 'DC', 'LastName': 'Metzger', 'Affiliation': 'Ballad Health CVA Heart Institute, Kingsport, Tennessee.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cox', 'Affiliation': 'CVA Brookwood Baptist Hospital, Birmingham, Alabama.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Duffy', 'Affiliation': 'Reid Heart Center, FirstHealth of the Carolinas, Pinehurst, North Carolina.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Brodie', 'Affiliation': 'LeBauer-Brodie Center for Cardiovascular Research and Education/Cone Health, Greensboro, North Carolina.'}, {'ForeName': 'Ernest L', 'Initials': 'EL', 'LastName': 'Mazzaferri', 'Affiliation': 'The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Clinical Trails Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trails Center, Cardiovascular Research Foundation, New York, New York.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28577']
1149,31721467,"Effects of dapagliflozin on the serum levels of fibroblast growth factor 21 and myokines and muscle mass in Japanese patients with type 2 diabetes: A randomized, controlled trial.","AIMS/INTRODUCTION


Our aims were to examine the add-on effects of a sodium-glucose cotransporter 2 inhibitor, dapagliflozin, compared with existing antidiabetes treatments, on anthropometric/metabolic parameters, the levels of an endocrine regulator, fibroblast growth factor 21 (FGF21); a skeletal muscle mass (SMM) negative regulator, myostatin; and a metabolic regulator, irisin, in patients with type 2 diabetes.
MATERIALS AND METHODS


A total of 54 patients with type 2 diabetes were randomly divided into dapagliflozin and control groups. The dapagliflozin group received dapagliflozin 5 mg/day in addition to conventional therapy for 24 weeks. The primary outcome was the change in the level of serum FGF21 from baseline. The secondary outcomes included changes from baseline in anthropometric/metabolic parameters and serum levels of myostatin and irisin.
RESULTS


Bodyweight decreased in the dapagliflozin group compared with the control group (P < 0.001), but the changes in SMM were not significant between the groups (P = 0.611), thereby elevating the ratio of SMM-to-bodyweight in the dapagliflozin group (P = 0.028). Myostatin levels were significantly decreased (P = 0.010), and irisin levels showed a nearly significant reduction (P = 0.052) in the dapagliflozin group compared with the control group, whereas FGF21 levels did not change significantly from baseline to the end of the intervention in both the dapagliflozin (P = 0.673) and the control (P = 0.823) groups.
CONCLUSIONS


Dapagliflozin add-on therapy in patients with type 2 diabetes reduced myostatin levels significantly and maintained SMM, without significant changes in FGF21 levels.",2020,"Myostatin levels were significantly decreased (P = 0.010), and irisin levels showed a nearly significant reduction (P = 0.052), in the dapagliflozin group compared with the control group, whereas FGF21 levels did not change significantly from baseline to the end of intervention in both the dapagliflozin (P = 0.673) and the control (P = 0.823) groups.
","['patients with type 2 diabetes', 'Japanese patients with type 2 diabetes', 'Fifty-four patients with type 2 diabetes']","['dapagliflozin', 'sodium-glucose cotransporter 2 inhibitor, dapagliflozin']","['myostatin levels', 'changes from baseline in anthropometric/metabolic parameters and serum levels of myostatin and irisin', 'serum levels of fibroblast growth factor 21 and myokines and muscle mass', 'irisin levels', 'Myostatin levels', 'Body weight (BW', 'level of serum FGF21', 'FGF21 levels', 'skeletal muscle mass (SMM', 'ratio of SMM/BW']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1457899', 'cui_str': 'GDF-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",54.0,0.0322135,"Myostatin levels were significantly decreased (P = 0.010), and irisin levels showed a nearly significant reduction (P = 0.052), in the dapagliflozin group compared with the control group, whereas FGF21 levels did not change significantly from baseline to the end of intervention in both the dapagliflozin (P = 0.673) and the control (P = 0.823) groups.
","[{'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Yamakage', 'Affiliation': 'Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Odori', 'Affiliation': 'Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kusakabe', 'Affiliation': 'Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Satoh-Asahara', 'Affiliation': 'Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13179']
1150,31320694,Child and adult snack food intake in response to manipulated pre-packaged snack item quantity/variety and snack box size: a population-based randomized trial.,"OBJECTIVES


Snacks contribute to overconsumption of energy-dense foods and thence obesity. Previous studies in this area are limited by self-reported data and small samples. In a large population-based cohort of parent-child dyads, we investigated how modification of pre-packaged snack food, i.e. (a) item quantity and variety, and (b) dishware (boxed container) size affected intake.
METHODS


Design: Randomized trial nested within the cross-sectional Child Health CheckPoint of the Longitudinal Study of Australian Children, clustered by day of visit.
SAMPLE


1299 11-12 year olds, 1274 parents.
EXPOSURE


2 × 2 manipulation of snack box container size and item quantity/variety: (1) small box, few items, (2) large box, few items, (3) small box, more items, (4) large box, more items.
PROCEDURE


Participants received a snack box during a 15 min break within their 3.5 h visit; any snacks remaining were weighed.
OUTCOMES


Consumed quantity (grams) and energy intake (kilojoules).
ANALYSES


Unadjusted linear regression.
RESULTS


Children who were offered a greater quantity and variety of snack items consumed considerably more energy and a slightly higher food mass (main effect for energy intake: 349 kJ, 95% CI 282-416, standardized mean difference (effect size) 0.66; main effect for mass: 10 g, 95% CI 3-17, effect size 0.17). In contrast, manipulating box size had little effect on child consumption, and neither box size nor quantity/variety of items consistently affected adults' consumption.
CONCLUSION


In children, reducing the number and variety of snack food items available may be a more fruitful intervention than focusing on container or dishware size. Effects observed among adults were small, although we could not exclude social desirability bias in adults aware of observation.",2019,"RESULTS


Children who were offered a greater quantity and variety of snack items consumed considerably more energy and a slightly higher food mass (main effect for energy intake: 349 kJ, 95% CI 282-416, standardized mean difference (effect size) 0.66; main effect for mass: 10 g, 95% CI 3-17, effect size 0.17).","['1299 11-12 year olds, 1274 parents', 'cross-sectional Child Health CheckPoint of the Longitudinal Study of Australian Children, clustered by day of visit', 'Design']",['snack box during a 15\u2009min break within their 3.5\u2009h visit; any snacks remaining were weighed'],['Consumed quantity (grams) and energy intake (kilojoules'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",1274.0,0.269442,"RESULTS


Children who were offered a greater quantity and variety of snack items consumed considerably more energy and a slightly higher food mass (main effect for energy intake: 349 kJ, 95% CI 282-416, standardized mean difference (effect size) 0.66; main effect for mass: 10 g, 95% CI 3-17, effect size 0.17).","[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Kerr', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia. jessica.kerr@mcri.edu.au.""}, {'ForeName': 'Pauline W', 'Initials': 'PW', 'LastName': 'Jansen', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia.""}, {'ForeName': 'Fiona K', 'Initials': 'FK', 'LastName': 'Mensah', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia.""}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Gibbons', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia.""}, {'ForeName': 'Tim S', 'Initials': 'TS', 'LastName': 'Olds', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia.""}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Carlin', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia.""}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Clifford', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burgner', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gold', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia.""}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Baur', 'Affiliation': 'Discipline of Child and Adolescent Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wake', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia.""}]",International journal of obesity (2005),['10.1038/s41366-019-0407-z']
1151,30216697,"Contribution of commercial infant products and fortified staple foods to nutrient intake at ages 6, 12, and 18 months in a cohort of children from a low socio-economic community in South Africa.","Fortification of two staple foods, maize meal and wheat flour (bread), is mandatory, and commercial infant products are widely available in South Africa. Using a 24-hr recall, we determined the contribution of these foods towards nutrient intakes at ages 6 (n = 715), 12 (n = 446), and 18 (n = 213) months in a cohort of children in a peri-urban community, North West province. On the day of recall, commercial infant products were consumed by 83% of children at 6 months, 46% at 12 months, and 15% at 18 months; fortified staples were consumed by 23%, 81%, and 96%, respectively. For consumers thereof, commercial infant products contributed 33% energy and 94% iron intakes at 6 months and 27% energy and 56% iron intakes at 12 months; nutrient densities of the complementary diet was higher than for nonconsumers for most micronutrients. For consumers of fortified staples, energy contribution thereof was 11% at 6 months versus 29% at 18 months; at 18 months, fortified staples contributed >30% of iron, zinc, vitamin A, thiamine, niacin, vitamin B6, and folate; at 12 months, nutrient densities of the complementary diet were higher for zinc, folate, and vitamin B6 but lower for calcium, iron, vitamin A, niacin, and vitamin C than nonconsumers. At ages 12 and 18 months, ~75% of children had low calcium intakes. At 12 months, 51.4% of consumers versus 25.0% (P = 0.005) of nonconsumers of fortified staples had adequate intakes (>EAR) for all eight fortificant nutrients. However, despite fortification, nutrient gaps remain.",2019,"At 12 months, 51.4% of consumers versus 25.0% (P = 0.005) of nonconsumers of fortified staples had adequate intakes (>EAR) for all eight fortificant nutrients.","['to nutrient intake at ages 6, 12, and 18\xa0months in a cohort of children from a low socio-economic community in South Africa', 'ages 6 (n\xa0=\xa0715), 12 (n\xa0=\xa0446), and 18 (n\xa0=\xa0213) months in a cohort of children in a peri-urban community, North West province']","['commercial infant products and fortified staple foods', 'staple foods, maize meal and wheat flour (bread']",['low calcium intakes'],"[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour (substance)'}, {'cui': 'C0006138', 'cui_str': 'Bread'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}]",715.0,0.0885825,"At 12 months, 51.4% of consumers versus 25.0% (P = 0.005) of nonconsumers of fortified staples had adequate intakes (>EAR) for all eight fortificant nutrients.","[{'ForeName': 'Eloïse', 'Initials': 'E', 'LastName': 'Swanepoel', 'Affiliation': 'Centre of Excellence for Nutrition (CEN), North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'Havemann-Nel', 'Affiliation': 'Centre of Excellence for Nutrition (CEN), North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'Marinel', 'Initials': 'M', 'LastName': 'Rothman', 'Affiliation': 'Centre of Excellence for Nutrition (CEN), North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'Laubscher', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Tonderayi M', 'Initials': 'TM', 'LastName': 'Matsungo', 'Affiliation': 'Centre of Excellence for Nutrition (CEN), North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'Cornelius M', 'Initials': 'CM', 'LastName': 'Smuts', 'Affiliation': 'Centre of Excellence for Nutrition (CEN), North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Faber', 'Affiliation': 'Centre of Excellence for Nutrition (CEN), North-West University, Potchefstroom, South Africa.'}]",Maternal & child nutrition,['10.1111/mcn.12674']
1152,31889783,The efficacy of ropivacaine and bupivacaine in the caesarean section and the effect on the vital signs and the hemodynamics of the lying-in women.,"Objective


To investigate the efficacy of ropivacaine and bupivacaine in caesarean section and vital signs and the hemodynamics of the lying-in women.
Methods


A total of 480 lying-in women who were admitted to this hospital for treatment between December 2017 and June 2018 were enrolled into this study as the subjects, which were divided into the experiment group and the control group, with 240 subjects in each group. In the experiment group, subjects received the local anesthesia by infusion of 1.5 mL ropivacaine (0.75%), while those in the control group also took the local anesthesia by infusion of 1.5 mL bupivacaine (0.75%). Thereafter, we observed the differences in the anesthetic efficiency, vital signs and hemodynamics of the lying-in women between two groups.
Results


The excellent and good rates of the anesthesia in two groups were 92.1% and 87.9%, showing no obvious difference; in the experiment group, the average arterial pressures and systolic pressures at 5 min and 10 min after combined spinal and epidural analgesia (CSEA) were all elevated when comparing to the control group (all  P  < 0.05); in the experiment group, the onset time was obviously extended, while duration of sensory and motor block and the duration of motor block were all shorter than those in the control group (all  P  < 0.05). During anesthesia, the incidence rate of the adverse reactions in the control group was 2.50%, significantly higher than 0.83% in the experiment group ( P  < 0.05).
Conclusion


Despite that ropivacaine and bupivacaine are efficient in anesthesia in the CSEA in the caesarean section, ropivacaine is more recommended for little influence on the hemodynamics, shorter duration of sensory block and motor block and low incidence rate of adverse reactions, which are conducive to the recovery and also safe to the patients.",2019,"During anesthesia, the incidence rate of the adverse reactions in the control group was 2.50%, significantly higher than 0.83% in the experiment group ( P  < 0.05).
","['women', 'A total of 480 lying-in women who were admitted to this hospital for treatment between December 2017 and June 2018 were enrolled into this study as the subjects, which were divided into the experiment group and the control group, with 240 subjects in each group']","['ropivacaine', 'ropivacaine and bupivacaine', 'local anesthesia by infusion of 1.5\u202fmL bupivacaine', 'bupivacaine', 'local anesthesia by infusion of 1.5\u202fmL ropivacaine']","['excellent and good rates of the anesthesia', 'caesarean section and vital signs', 'duration of sensory and motor block and the duration of motor block', 'anesthetic efficiency, vital signs and hemodynamics of the lying', 'incidence rate of the adverse reactions', 'onset time', 'average arterial pressures and systolic pressures']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0518766'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",2018.0,0.0196561,"During anesthesia, the incidence rate of the adverse reactions in the control group was 2.50%, significantly higher than 0.83% in the experiment group ( P  < 0.05).
","[{'ForeName': 'Huaizhao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Qingdao Huangdao District Central Hospital, Qingdao 266400, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology, Qingdao Huangdao District Central Hospital, Qingdao 266400, China.'}, {'ForeName': 'Ruixue', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Qingdao Huangdao District Central Hospital, Qingdao 266400, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Shantou University Medical College, Shantou 515041, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Qingdao Huangdao District Central Hospital, Qingdao 266400, China.'}, {'ForeName': 'Jinxin', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of Anesthesiology, Qingdao Municipal Hospital, Qingdao 266011, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2019.07.014']
1153,31585489,"The 24-hr, 28-day, and 7-day post-moisturizing efficacy of ceramides 1, 3, 6-II containing moisturizing cream compared with hydrophilic cream on skin dryness and barrier disruption in senile xerosis treatment.","Direct replacement of decreased ceramides in the stratum corneum can be efficacious for skin hydration, skin barrier function, and skin pH. Our study aimed to evaluate the 24-hr, 28-day, and 7-day post-moisturizing efficacy of ceramide-containing moisturizer in senile xerosis treatment. A split site, double-blinded, randomized, controlled study was conducted in 24 senile subjects (91.7% females, mean age 54.83 ± 5.45 years) with mild to moderate xerosis, who were randomized to receive ceramide-containing moisturizer or hydrophilic cream, daily applied on each side of the shin. A single application of ceramide-containing moisturizer increased skin hydration, while improving transepidermal water loss (TEWL) and skin pH for up to 24 hr, with statistically significant difference. After 28 days of twice-daily application, more significant improvement on skin hydration, barrier function, and skin pH was observed in those with ceramide-containing moisturizer at all-time points. At day 28, there was a statistically significant decrease of hemoglobin index, wrinkle, and texture on the ceramide treated side. The 7-day post-moisturizing efficacy on the ceramide treated side was superior for skin hydration, TEWL, skin pH, and wrinkle. Thus, the ceramide-containing moisturizer can be a novel promising treatment for senile xerosis.",2019,"At day 28, there was a statistically significant decrease of hemoglobin index, wrinkle and texture on the ceramide treated side.","['senile xerosis treatment', '24 senile subjects (91.7% females, mean age 54.83 ±\u20095.45\u2009years) with mild to moderate xerosis']","['ceramide-containing moisturizer', 'ceramide-containing moisturizer or hydrophilic cream', 'hydrophilic cream']","['skin hydration, TEWL, skin pH, and wrinkle', 'skin dryness and barrier disruption', 'skin hydration', 'hemoglobin index, wrinkle and texture on the ceramide treated side', 'skin hydration, skin barrier function, and skin', 'transepidermal water loss (TEWL) and skin pH', 'skin hydration, barrier function, and skin pH']","[{'cui': 'C0406307', 'cui_str': 'Senile xeroderma (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0259817', 'cui_str': 'Xerosis'}]","[{'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0475370', 'cui_str': 'Hydrophilicity'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0232445', 'cui_str': 'Skin pH (observable entity)'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0043047', 'cui_str': 'Water'}]",,0.0323145,"At day 28, there was a statistically significant decrease of hemoglobin index, wrinkle and texture on the ceramide treated side.","[{'ForeName': 'Suparuj', 'Initials': 'S', 'LastName': 'Lueangarun', 'Affiliation': 'Division of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Piyanuch', 'Initials': 'P', 'LastName': 'Tragulplaingam', 'Affiliation': 'Division of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Supanee', 'Initials': 'S', 'LastName': 'Sugkraroek', 'Affiliation': 'Division of Dermatology and Aesthetic, Bumrungrad International Hospital, Bangkok, Thailand.'}, {'ForeName': 'Therdpong', 'Initials': 'T', 'LastName': 'Tempark', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand.'}]",Dermatologic therapy,['10.1111/dth.13090']
1154,31769172,Early morning home blood pressure control among treated patients with controlled office blood pressure.,"Elevated morning blood pressure (BP) has a significantly increased risk of cardiovascular events, so morning BP is of substantial clinical importance for the management of hypertension. This study aimed to evaluate early morning BP control and its determines among treated patients with controlled office BP. From May to October 2018, 600 treated patients with office BP < 140/90 mm Hg were recruited from hypertension clinics. Morning BP was measured at home for 7 days. Morning home systolic blood pressure (SBP) increased by an average of 11.5 mm Hg and that morning home diastolic blood pressure (DBP) increased by an average of 5.6 mm Hg compared with office BP. Morning home SBP, DBP, and their moving average were more likely to be lower among patients with a office SBP < 120 mm Hg than among patients with a office SBP ranging from 120 to 129 mm Hg and from 130 to 139 mm Hg (P < .001). A total of 45% of patients had early morning BP < 135/85 mm Hg. The following factors were significantly correlated with morning BP control: male sex, age of <65 years, absence of habitual snoring, no drinking, adequate physical activity, no habit of high salt intake, office BP < 120/80 mm Hg, and combination of a calcium channel blocker (CCB) and angiotensin receptor blocker or angiotensin-converting enzyme inhibitor (ARB/ACEI). Less than half of patients with controlled office BP had controlled morning BP and that positive changes may be related to an office BP < 120/80 mm Hg, combination of a CCB and ACEI/ARB and a series of lifestyle adjustments.",2019,Morning home systolic blood pressure (SBP) increased by an average of 11.5 mm Hg and that morning home diastolic blood pressure (DBP) increased by an average of 5.6 mm Hg compared with office BP.,"['treated patients with controlled office BP', '\xa0135/85', 'treated patients with controlled office blood pressure', '600 treated patients with office BP', 'Hg were recruited from hypertension clinics']",['calcium channel blocker (CCB) and angiotensin receptor blocker or angiotensin-converting enzyme inhibitor (ARB/ACEI'],"['controlled morning BP', 'Elevated morning blood pressure (BP', 'office BP', 'diastolic blood pressure (DBP', 'Morning home SBP, DBP, and their moving average', 'Morning BP', 'early morning BP', 'Morning home systolic blood pressure (SBP']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3715181', 'cui_str': 'Hypertension clinic (environment)'}]","[{'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",600.0,0.0520321,Morning home systolic blood pressure (SBP) increased by an average of 11.5 mm Hg and that morning home diastolic blood pressure (DBP) increased by an average of 5.6 mm Hg compared with office BP.,"[{'ForeName': 'Hui-Juan', 'Initials': 'HJ', 'LastName': 'Zuo', 'Affiliation': 'Department of Community Health Research, Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xian-Tao', 'Initials': 'XT', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hong-Xia', 'Initials': 'HX', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Li-Qun', 'Initials': 'LQ', 'LastName': 'Deng', 'Affiliation': 'Department of General Practice, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jin-Wen', 'Initials': 'JW', 'LastName': 'Wang', 'Affiliation': 'Department of Community Health Research, Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13736']
1155,31898551,Effects of a cognitive ergonomics workplace intervention (CogErg) on cognitive strain and well-being: a cluster-randomized controlled trial. A study protocol.,"BACKGROUND


Cognitively straining conditions such as disruptions, interruptions, and information overload are related to impaired task performance and diminished well-being at work. It is therefore essential that we reduce their harmful consequences to individual employees and organizations. Our intervention study implements practices for managing the cognitive strain typical to office work tasks and working conditions in offices. We will examine the effects of a cognitive ergonomics intervention on working conditions, workflow, well-being, and productivity.
METHODS/DESIGN


The study is a stratified cluster randomized trial. The clusters are work units, for example, teams or offices. The four participating organizations entered a total of 36 clusters, and we invited all 1169 knowledge employees of these units to participate. We randomly allocated the clusters into an intervention group (cognitive ergonomics) or an active control group (recovery supporting). We invited an additional 471 participants to join a passive control group only for baseline and follow-up measurements, with no intervention. The study consists of a baseline survey and interviews and observations at the workplace, followed by an intervention. It starts with a workshop defining the specific actions for the intervention implementation stage, during which we send task reminder questionnaires to all employees to support behaviour change at the individual and team levels. The primary outcome measure is perceived frequency of cognitive strain from working conditions; the secondary outcome measures include subjective cognitive load, well-being, workflow/productivity, and cognitive stress symptoms. Process evaluation uses the quantitative and qualitative data obtained during the implementation and evaluation phases. The baseline measurements, intervention phase, and end-of-treatment measurements are now complete, and follow-up will continue until November 2019.
DISCUSSION


There is a need to expand the research of cognitive strain, which poses a considerable risk to work performance and employee well-being in cognitively demanding tasks. Our study will provide new information about factors that contribute to such strain. Most importantly, the results will show which evidence-based cognitive ergonomic practices support work performance in knowledge work, and the project will provide concrete examples of how to improve at work.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03573674. Registered 29 June 2018.",2020,"BACKGROUND


Cognitively straining conditions such as disruptions, interruptions, and information overload are related to impaired task performance and diminished well-being at work.","['471 participants to join a', 'The four participating organizations entered a total of 36 clusters, and we invited all 1169 knowledge employees of these units to participate', 'offices']","['passive control group only for baseline and follow-up measurements, with no intervention', 'intervention group (cognitive ergonomics) or an active control group (recovery supporting', 'cognitive ergonomics workplace intervention (CogErg', 'cognitive ergonomics intervention']","['subjective cognitive load, well-being, workflow/productivity, and cognitive stress symptoms', 'frequency of cognitive strain from working conditions', 'working conditions, workflow, well-being, and productivity']","[{'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3539085', 'cui_str': 'All'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4505392', 'cui_str': 'Cognitive Ergonomics'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",471.0,0.0803982,"BACKGROUND


Cognitively straining conditions such as disruptions, interruptions, and information overload are related to impaired task performance and diminished well-being at work.","[{'ForeName': 'Virpi', 'Initials': 'V', 'LastName': 'Kalakoski', 'Affiliation': 'Finnish Institute of Occupational Health, P.O Box 40, 00032, Helsinki, Finland. virpi.kalakoski@ttl.fi.'}, {'ForeName': 'Sanna', 'Initials': 'S', 'LastName': 'Selinheimo', 'Affiliation': 'Finnish Institute of Occupational Health, P.O Box 40, 00032, Helsinki, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Valtonen', 'Affiliation': 'Finnish Institute of Occupational Health, P.O Box 40, 00032, Helsinki, Finland.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Turunen', 'Affiliation': 'Finnish Institute of Occupational Health, P.O Box 40, 00032, Helsinki, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Käpykangas', 'Affiliation': 'Finnish Institute of Occupational Health, P.O Box 40, 00032, Helsinki, Finland.'}, {'ForeName': 'Hilkka', 'Initials': 'H', 'LastName': 'Ylisassi', 'Affiliation': 'Finnish Institute of Occupational Health, P.O Box 40, 00032, Helsinki, Finland.'}, {'ForeName': 'Pauliina', 'Initials': 'P', 'LastName': 'Toivio', 'Affiliation': 'Finnish Institute of Occupational Health, P.O Box 40, 00032, Helsinki, Finland.'}, {'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Järnefelt', 'Affiliation': 'Finnish Institute of Occupational Health, P.O Box 40, 00032, Helsinki, Finland.'}, {'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Hannonen', 'Affiliation': 'Finnish Institute of Occupational Health, P.O Box 40, 00032, Helsinki, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Paajanen', 'Affiliation': 'Finnish Institute of Occupational Health, P.O Box 40, 00032, Helsinki, Finland.'}]",BMC psychology,['10.1186/s40359-019-0349-1']
1156,31253437,Changes in positive affect in cognitive-behavioral treatment of anxiety disorders.,"OBJECTIVE


This study evaluated changes in positive affect within cognitive-behavioral treatments (CBT) for anxiety disorders. It was hypothesized that there would be significantly greater increases in positive affect in CBT conditions compared to the waitlist, and particularly higher in the Unified Protocol (UP) than the single disorder protocols (SDP) given the UP's focus on emotions (including positive emotions) rather than symptoms.
METHOD


Patients with heterogeneous anxiety disorders (N = 223) were randomly assigned to the UP, SDP or waitlist. Linear mixed model regression (intent to treat) analyses were used to compare change in positive affect, quality of life, and savoring between patients in the treatment conditions (UP and SDP) versus waitlist conditions. Between condition effect sizes were calculated to assess the magnitude of difference within conditions at post-treatment.
RESULTS


Results indicated a significant Group (treatment vs. waitlist) × Time (pre- post-treatment) interaction (F(1, 154.36) = 6.75; p = .01) for positive affect in which the treatment group showed significant improvements in positive affect pre- to post-treatment (ESsg = 0.37, SEsg = 0.09, 95% CI [0.20: 0.54]) and the waitlist condition did not. There were no differences between UP and SDP conditions in positive affect at baseline or at post-treatment.
CONCLUSIONS


These results suggest CBT, which typically focuses on reductions in negative affect, may also improve positive affect. The importance of future research evaluating, targeting, and improving positive affect in CBT trials is discussed. Clinicaltrials.gov Identifier: NCT01243606.",2019,"There were no differences between UP and SDP conditions in positive affect at baseline or at post-treatment.
","['Patients with heterogeneous anxiety disorders (N\u202f=\u202f223', 'anxiety disorders']","['UP, SDP or waitlist', 'cognitive-behavioral treatments (CBT']","['UP and SDP conditions', 'quality of life, and savoring']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0034380'}]",223.0,0.0378923,"There were no differences between UP and SDP conditions in positive affect at baseline or at post-treatment.
","[{'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Wilner Tirpak', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, United States of America. Electronic address: jwilner@bu.edu.'}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Cassiello-Robbins', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, United States of America.'}, {'ForeName': 'Amantia', 'Initials': 'A', 'LastName': 'Ametaj', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, United States of America.'}, {'ForeName': 'Olenka S', 'Initials': 'OS', 'LastName': 'Olesnycky', 'Affiliation': 'Department of Psychology, Hofstra University, United States of America.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Sauer-Zavala', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, United States of America.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, United States of America.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Center for Anxiety and Related Disorders, Boston University, United States of America.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2019.06.008']
1157,30426668,Associations between antenatal depression and neonatal outcomes in Malawi.,"Studies from several low- and middle-income countries have shown that antenatal depression may be a risk factor for poor neonatal outcomes. However, those studies conducted in sub-Saharan Africa have not consistently demonstrated this association. We set out to investigate whether antenatal depression is associated with shorter duration of pregnancy and reduced newborn size in rural Malawi. Pregnant women recruited from four antenatal clinics to the International Lipid-Based Nutrient Supplements Project-DYAD-Malawi (iLiNS-DYAD-M) randomised controlled trial of nutrient supplementation were screened for antenatal depression in the second or third trimester using a locally validated version of the Self Reporting Questionnaire (SRQ). Outcomes were duration of pregnancy, birthweight, newborn length for age z-score (LAZ), head circumference z-score, and mid-upper arm circumference (MUAC). Other potential confounding factors and predictors of birth outcome were measured and adjusted for in the analysis. 1,391 women were enrolled to the trial. 1,006/1,391 (72.3%) of these women completed an SRQ and gave birth to a singleton infant whose weight was measured within 2 weeks of birth. 143/1,006 (14.2%) scored SRQ ≥ 8, indicating likely depression. Antenatal depression was not associated with birth weight, duration of pregnancy, newborn LAZ, or head-circumference Z-score. There was an inverse association with newborn MUAC (adjusted mean difference - 0.2 cm (95% CI -0.4 to 0, p = 0.021) the significance of which is unclear. The study was conducted within a randomised controlled trial of nutritional supplementation and there was a high proportion of missing data in some enrolment sites; this may have affected the validity of our findings.",2019,"Antenatal depression was not associated with birth weight, duration of pregnancy, newborn LAZ, or head-circumference Z-score.","['1,391 women were enrolled to the trial', 'Pregnant women recruited from four antenatal clinics to the']","['International Lipid-Based Nutrient Supplements Project-DYAD-Malawi', 'nutritional supplementation', 'nutrient supplementation']","['Antenatal depression', 'Self Reporting Questionnaire (SRQ', 'duration of pregnancy, birthweight, newborn length for age z-score (LAZ), head circumference z-score, and mid-upper arm circumference (MUAC', 'birth weight, duration of pregnancy, newborn LAZ, or head-circumference Z-score', 'antenatal depression', 'newborn MUAC']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference (observable entity)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}]",1391.0,0.108098,"Antenatal depression was not associated with birth weight, duration of pregnancy, newborn LAZ, or head-circumference Z-score.","[{'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Stewart', 'Affiliation': 'Department of Mental Health, College of Medicine, University of Malawi and Division of Psychiatry, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Centre for Child Health Research, University of Tampere Faculty of Medicine and Life Sciences, Tampere, Finland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Umar', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Centre for Child Health Research, University of Tampere Faculty of Medicine and Life Sciences, Tampere, Finland.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Creed', 'Affiliation': 'Neuroscience and Mental Health, University of Manchester, UK.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Institute of Psychology, Health and Society, University of Liverpool, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Tomenson', 'Affiliation': 'Neuroscience and Mental Health, University of Manchester, UK.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Prado', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre, Malawi.'}]",Maternal & child nutrition,['10.1111/mcn.12709']
1158,31899739,"Did Osteoblastic Cell Therapy Improve the Prognosis of Pre-fracture Osteonecrosis of the Femoral Head? A Randomized, Controlled Trial.","BACKGROUND


In patients with nontraumatic osteonecrosis of the femoral head (ONFH), implantation of bone marrow aspirate concentrate (BMAC) could delay the progression of osteonecrosis and improve symptoms in pre-fracture ONFH. However, the BMAC content, especially in osteoblastic stem cells, could have an important individual variability. An autologous osteoblastic cell product could improve the effect of such cell-based therapy.
QUESTIONS/PURPOSES


(1) Does autologous osteoblastic cell therapy decrease the likelihood of progression to subchondral fracture with or without early collapse corresponding to Association Research Circulation Osseous (ARCO) classification Stage III or higher, and provide a clinically important pain improvement compared with BMAC treatment alone? (2) Were patients treated with osteoblastic cell therapy less likely to undergo subsequent THA? (3) What proportion of patients in the treatment and control groups experienced adverse events after surgery?
METHODS


Between 2004 and 2011, we treated 279 patients for Stage I to II hip osteonecrosis (ON) with surgery. During that time, our general indications for surgery in this setting included non-fracture ON lesions. To be eligible for this randomized, single-blind trial, patients needed to have an ONFH Stage I or II; we excluded those with traumatic ONFH, hemoglobinopathies and positive serology for hepatitis B, C or HIV. Of those treated surgically for this diagnosis during the study period, 24% (67) agreed to participate in this randomized trial. Hips with pre-fracture ONFH were randomly treated with a core decompression procedure associated with either implantation of a BMAC (BMAC group; n = 26) or osteoblastic cell (osteoblastic cell group; n = 30). The groups were not different in terms of clinical and imaging characteristics. The primary study outcome was treatment response, defined as the absence of progression to subchondral fracture stage (ARCO stage III or higher) plus a clinically important pain improvement defined as 1 cm on a 10-cm VAS. The secondary endpoint of interest was the frequency in each group of subsequent THA and the frequency of adverse events. The follow-up duration was 36 months. We used an as-treated analysis (rather than intention-to-treat) for our efficacy endpoint, and an intention-to-treat analysis for adverse events. Overall, 26 of 26 patients in the BMAC group and 27 of 30 in the osteoblastic cell group completed the trial.
RESULTS


At 36 months, no clinically important differences were found in any study endpoint. There was no difference in the proportion of patients who had progressed to fracture (ARCO stage III or higher; 46% of the BMAC hips [12 of 26] versus 22% in the hips with osteoblastic cells [six of 27], hazard ratio, 0.47 [95% CI 0.17 to 1.31]; p = 0.15). There was no clinically important difference in VAS pain scores. No differences were found for either the WOMAC or the Lequesne indexes. With the numbers available, there was no difference in the proportion of patients in the groups who underwent THA at 36 months 15% (four of 27) with osteoblastic cells versus 35% (nine of 26) with BMAC; p = 0.09 With the numbers available, we found no differences between the treatment and control groups in terms of the frequencies of major adverse events.
CONCLUSIONS


We found no benefit to osteoblastic cells over BMAC in patients with pre-collapse ONFH; side effects were uncommon and generally mild in both groups. This study could be used as pilot data to help determine sample sizes for larger (presumably multicenter) randomized controlled trials. However, this novel treatment cannot be recommended in routine practice until future, larger studies demonstrate efficacy.
LEVEL OF EVIDENCE


Level II, therapeutic study.",2020,No differences were found for either the WOMAC or the Lequesne indexes.,"['patients needed to have an ONFH Stage I or II; we excluded those with traumatic ONFH, hemoglobinopathies and positive serology for hepatitis B, C or HIV', '26 patients in the BMAC group and 27 of 30 in the osteoblastic cell group completed the trial', 'Hips with pre-fracture ONFH', 'patients with nontraumatic osteonecrosis of the femoral head (ONFH), implantation of', 'Between 2004 and 2011', '279 patients for Stage I to II hip osteonecrosis (ON) with surgery']","['autologous osteoblastic cell therapy', 'bone marrow aspirate concentrate (BMAC', 'core decompression procedure associated with either implantation of a BMAC (BMAC group; n = 26) or osteoblastic cell (osteoblastic cell', 'Osteoblastic Cell Therapy', 'osteoblastic cell therapy']","['absence of progression to subchondral fracture stage (ARCO stage III or higher) plus a clinically important pain improvement defined as 1 cm on a 10-cm VAS', 'subsequent THA and the frequency of adverse events', 'adverse events', 'VAS pain scores']","[{'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0019045', 'cui_str': 'Hemoglobinopathies'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0036745', 'cui_str': 'Serology'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0302189', 'cui_str': 'Cell Therapy'}, {'cui': 'C0857285', 'cui_str': 'Marrow aspirate'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]","[{'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2743413', 'cui_str': 'ARCO'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.116832,No differences were found for either the WOMAC or the Lequesne indexes.,"[{'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Hauzeur', 'Affiliation': 'J.-P. Hauzeur, Rheumatology and Physical Medicine Department, Hospital Erasme, Université Libre de Bruxelles, Brussels, Belgium C. Lechanteur, Y. Beguin, E. Baudoux, Haematology & Laboratory of Cell Therapy, CHU de Liège, Université de Liège, Liège, Belgium V. De Maertelaer, SBIM & IRIBHM, Faculty of Medicine, Université Libre de Bruxelles, Brussels, Belgium S. Pather, R. Katz, Radiology Department, Hospital Erasme, Université Libre de Bruxelles, Brussels, Belgium. M. Malaise, J.-P. Hauzeur, Department of Rheumatology, CHU de Liège, Université de Liège, Liège, Belgium J. Ino, Bone Therapeutics S.A., Gosselies, Belgium.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Lechanteur', 'Affiliation': ''}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Baudoux', 'Affiliation': ''}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'De Maertelaer', 'Affiliation': ''}, {'ForeName': 'Sanjiva', 'Initials': 'S', 'LastName': 'Pather', 'Affiliation': ''}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Malaise', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ino', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Beguin', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001107']
1159,31895298,"Lactalbumin, Not Collagen, Augments Muscle Protein Synthesis with Aerobic Exercise.","INTRODUCTION


Protein ingestion and the ensuing hyperaminoacidemia stimulates skeletal muscle protein synthesis in the postexercise period. This response facilitates muscle remodeling, which is important during intensified training. The aim of this study was to determine whether supplementation with α-lactalbumin (LA), with high leucine and tryptophan contents, would improve responses to short periods of intensified aerobic training compared with supplementation with an isonitrogenous quantity of collagen peptides (CP).
METHODS


Endurance-trained participants (5 male, 6 female, 24 ± 4 yr, V˙O2 = 53.2 ± 9.1 mL·kg·min, peak power output = 320 ± 48 W; means ± SD) consumed a controlled diet (1.0 g·kg·d protein) and refrained from habitual training for 11 d while taking part in this double-blind randomized, crossover trial. The two intervention phases, which consisted of brief intensified training (4 × 4-min cycling intervals at 70% of peak power output on 3 consecutive days) combined with the ingestion of LA or CP supplements after exercise (20 g) and before sleep (40 g), were separated by 4 d of washout without protein supplementation (i.e., the control phase). In response to each phase, myofibrillar (MyoPS), sarcoplasmic protein synthesis (SarcPS) rates (via H2O ingestion) and parameters of sleep quality were measured.
RESULTS


LA ingestion increased plasma leucine (P < 0.001) and tryptophan concentrations (P < 0.001) relative to CP. Intensified training increased MyoPS and SarcPS above the washout phase in LA- and CP-supplemented phases (P < 0.01), with increases being 13% ± 5% and 5% ± 7% greater with LA than CP for MyoPS (P < 0.01) and SarcPS, respectively (P < 0.01).
CONCLUSIONS


Despite an isonitrogenous diet, protein synthesis was enhanced to a greater extent when trained participants consumed LA compared with CP during intensified aerobic training, suggesting that protein quality is an important consideration for endurance-trained athletes aiming to augment adaption to exercise training.",2020,LA ingestion increased plasma leucine (p<0.001) and tryptophan concentrations (p<0.001) relative to CP.,"['Endurance trained participants (5M, 6F, 24 ± 4 years, V[Combining']","['brief intensified training (4×4-min cycling intervals at 70% of PPO on 3 consecutive days) combined with the ingestion of LA or CP supplements post-exercise', 'supplementation with α-Lactalbumin (LA']","['myofibrillar (MyoPS), sarcoplasmic protein synthesis (SarcPS) rates (via H2O ingestion) and parameters of sleep quality', 'plasma leucine (p<0.001) and tryptophan concentrations (p<0.001) relative to CP', 'MyoPS and SarcPS']","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0022912', 'cui_str': 'Lactalbumin'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3177469', 'cui_str': '(pipzH2)(cdo)H2O'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]",320.0,0.0426972,LA ingestion increased plasma leucine (p<0.001) and tryptophan concentrations (p<0.001) relative to CP.,"[{'ForeName': 'Sara Y', 'Initials': 'SY', 'LastName': 'Oikawa', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Macinnis', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Tripp', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'McGlory', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Baker', 'Affiliation': 'Department of Neurology, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002253']
1160,30945430,"Efficacy and safety of moisturizer containing 5% panthenol, madecassoside, and copper-zinc-manganese versus 0.02% triamcinolone acetonide cream in decreasing adverse reaction and downtime after ablative fractional carbon dioxide laser resurfacing: A split-face, double-blinded, randomized, controlled trial.","INTRODUCTION


Fractional carbon dioxide (FrCO 2  ) laser is effective for atrophic acne scar treatment, but unavoidable downtime. Meanwhile, postoperative topical steroid decreases the downtime, yet still possibly increases other steroid side effects.
OBJECTIVE


To evaluate the efficacy and safety of moisturizer containing 5% panthenol, madecassoside, and copper-zinc-manganese (experimental cream) versus 0.02% Triamcinolone acetonide (TA) cream in decreasing adverse effects and downtime after FrCO 2  laser, with wound healing improvement and prevention of certain steroid-related side effects like postinflammatory hyperpigmentation (PIH).
METHODS


We conducted a double-blinded, split face, randomized controlled trial in 20 subjects receiving FrCO 2  laser on both sides of the faces and randomly treated with two posttreatment regimens on each side for 7 days. Clinical, expert panel assessment of photography, downtime, side effects, and biometric evaluation for erythema and melanin were performed on baseline, immediately after treatment, day 3, 5, 7, 14, 30 and, 60 postoperatively.
RESULTS


Both experimental cream (EC) and 0.02% TA cream could significantly reduce postlaser downtime including swelling, redness, crusting, and scaling in 5-7 days, with comparable efficacies in decreasing downtime and adverse reactions, as well as wound healing improvement and lower PIH without statistically significant difference between the two treatments. The incidence of PIH was 60% in the EC treated group with minimal intensity.
CONCLUSION


The moisturizer with anti-inflammatory ingredients could be a novel treatment modality for reduction of postablative laser downtime by using nonsteroidal anti-inflammatory agents to avoid adverse effects and improve wound healing process with lower PIH.",2019,"TA cream could significantly reduce postlaser downtime including swelling, redness, crusting, and scaling in 5-7 days, with comparable efficacies in decreasing downtime and adverse reactions, as well as wound healing improvement and lower PIH without statistically significant difference between the two treatments.",['20 subjects receiving FrCO 2  laser on both sides of the faces'],"['TA cream', 'ablative fractional carbon dioxide laser resurfacing', 'Fractional carbon dioxide (FrCO 2  ) laser', 'moisturizer containing 5% panthenol, madecassoside, and copper-zinc-manganese versus 0.02% triamcinolone acetonide cream', 'moisturizer containing 5% panthenol, madecassoside, and copper-zinc-manganese (experimental cream', 'Triamcinolone acetonide (TA) cream']","['adverse reaction and downtime', 'wound healing improvement and lower PIH', 'postlaser downtime including swelling, redness, crusting, and scaling', 'incidence of PIH', 'downtime and adverse reactions', 'Efficacy and safety', 'efficacy and safety']","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]","[{'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0392251', 'cui_str': 'CO2 Lasers'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1321598', 'cui_str': 'Panthenol'}, {'cui': 'C0297253', 'cui_str': 'madecassoside'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0373677', 'cui_str': 'Manganese measurement (procedure)'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0392749', 'cui_str': 'Crusted (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",20.0,0.128628,"TA cream could significantly reduce postlaser downtime including swelling, redness, crusting, and scaling in 5-7 days, with comparable efficacies in decreasing downtime and adverse reactions, as well as wound healing improvement and lower PIH without statistically significant difference between the two treatments.","[{'ForeName': 'Suparuj', 'Initials': 'S', 'LastName': 'Lueangarun', 'Affiliation': 'Division of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Aphinut', 'Initials': 'A', 'LastName': 'Srituravanit', 'Affiliation': 'Division of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Pathumthani, Thailand.'}, {'ForeName': 'Therdpong', 'Initials': 'T', 'LastName': 'Tempark', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.12951']
1161,26525461,Isolating active ingredients in a parent-mediated social communication intervention for toddlers with autism spectrum disorder.,"BACKGROUND


Behavioral interventions are commonplace in the treatment of autism spectrum disorders, yet relatively little is known about how and why these interventions work. This study tests the relationship between isolated core components of a packaged social communication intervention and the primary outcome, joint engagement, to better understand how the intervention is affecting change in individuals.
METHODS


A total of 86 toddlers and their parents were enrolled in the study and randomized to one of two treatments, the joint attention, symbolic play, engagement, and regulation (JASPER) parent-mediated intervention or a psychoeducational intervention. Measures regarding the parent's use of intervention strategies were collected before and after the 10-week intervention. Additional measures of child and parent joint engagement were also collected.
RESULTS


A significant effect of treatment was found for all four of the core strategies of the intervention, favoring a larger increase in the JASPER condition. A hierarchical linear regression revealed several individual predictors of joint engagement, including parent-rated buy-in, interventionist-rated parent involvement, and parental use of strategies. To complement the hierarchical analysis, we also tested the potential mediating effect the strategies may have on the relationship between treatment and joint engagement. Results showed that the strategy of mirrored pacing mediated the relationship between treatment and joint engagement in the positive direction.
CONCLUSIONS


These results strongly suggest that the mirrored pacing strategy is an active ingredient of the JASPER treatment.",2016,"A significant effect of treatment was found for all four of the core strategies of the intervention, favoring a larger increase in the JASPER condition.","['toddlers with autism spectrum disorder', 'individuals', 'autism spectrum disorders', '86 toddlers and their parents']","['packaged social communication intervention', 'social communication intervention', 'joint attention, symbolic play, engagement, and regulation (JASPER) parent-mediated intervention or a psychoeducational intervention']",[],"[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]",[],86.0,0.0334386,"A significant effect of treatment was found for all four of the core strategies of the intervention, favoring a larger increase in the JASPER condition.","[{'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Gulsrud', 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA, USA.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hellemann', 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Shire', 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Kasari', 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Los Angeles, CA, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.12481']
1162,31889795,Analgesic effect of the midazolam-induced anesthesia in different doses on the patients after the thoracoscopic resection of lung cancer.,"Objective


To elaborate the analgesic efficiency of midazolam-induced anesthesia in different doses on the patients following the thoracoscopic resection of lung cancer.
Methods


Ninety patients undergoing thoracoscopic resection of lung cancer between August 2017 and July 2018 were randomized in the observation group (n = 45) and the control group (n = 45). Patients in observation group underwent the anesthesia induced by 0.1 mg/kg midazolam, while for the control group, the dose was adjusted to 0.05 mg/kg. Then, we compared the levels of inflammatory factors, SaO 2 , average of arterial pressure and changes in heart rate before and after surgery (48 h) to analyze the efficacy.
Results


At the postoperative 48 h, patients in the observation group had lower levels of inflammatory factors when comparing with their counterparts in the control group [IL-6, IL-8, IL-1β and TNF-α: (58.44 ± 3.22) μg/L, (2.04 ± 0.26) μg/L, (2.98 ± 0.44) μg/L, (5.33 ± 0.77) μg/L  v.s.  (96.44 ± 4.54) μg/L, (3.23 ± 0.33) μg/L, (3.77 ± 0.44) μg/L, (7.64 ± 0.99) μg/L] ( P <  0.05). Meanwhile, those in the observation group had a lower SaO 2 , average arterial pressure and heart rate [(93.79 ± 1.08)%, (93.22 ± 3.46) mmHg, (87.55 ± 2.35) beat/min  v.s.  (97.13 ± 1.03)%, (96.44 ± 4.03) mmHg, (91.05 ± 2.89) beat/min] ( P <  0.05). However, no statistical significance was identified in the differences of the bleeding amount, surgical time and anesthesia time between two groups ( P >  0.05), while the eye-opening time and the extubation time in the observation group were all shorter than those in the control group ( P <  0.05). Similarly, the postoperative pain scores, total doses of propofol and remifentanil were also lowered ( P <  0.05).
Conclusion


For patients of thoracoscopic resection of lung cancer, midazolam-induced anesthesia (0.1 mg/kg) performs better than 0.5 mg/kg in inhibiting the inflammatory responses, with significant reduction in the dose of anesthetics, thereby stabilizing the status of patients in perioperative period and mitigating the postoperative pains. Thus, it is potential candidate.",2019,"However, no statistical significance was identified in the differences of the bleeding amount, surgical time and anesthesia time between two groups ( P >  0.05), while the eye-opening time and the extubation time in the observation group were all shorter than those in the control group ( P <  0.05).","['patients after the thoracoscopic resection of lung cancer', 'Ninety patients undergoing thoracoscopic resection of lung cancer between August 2017 and July 2018', 'patients following the thoracoscopic resection of lung cancer']","['midazolam-induced anesthesia', 'anesthesia induced by 0.1\u202fmg/kg midazolam']","['analgesic efficiency', 'bleeding amount, surgical time and anesthesia time', 'lower levels of inflammatory factors', 'lower SaO 2 , average arterial pressure and heart rate', 'postoperative pain scores, total doses of propofol and remifentanil', 'IL-6, IL-8, IL-1β and TNF-α', 'levels of inflammatory factors, SaO 2 , average of arterial pressure and changes in heart rate', 'eye-opening time and the extubation time', 'Analgesic effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",90.0,0.0487826,"However, no statistical significance was identified in the differences of the bleeding amount, surgical time and anesthesia time between two groups ( P >  0.05), while the eye-opening time and the extubation time in the observation group were all shorter than those in the control group ( P <  0.05).","[{'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Tianjin First Central Hospital, Tianjin 300190, China.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Gan', 'Affiliation': ""Department of Anesthesiology, The Affiliated Tangshan People's Hospital of North China University of Science and Technology, Tangshan 063000, China.""}, {'ForeName': 'Zhongci', 'Initials': 'Z', 'LastName': 'Dou', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2019.09.015']
1163,31889800,Changes of nutritional status and the variations of serum indicators of patients with chronic kidney disease accompanied by hypothyroidism taking thyroid hormone replacement therapy as the therapeutic models.,"This study aimed to analyze the incidence of malnutrition in patients with chronic kidney disease (CKD) at stage III-IV accompanied by hypothyroidism and indicate the improvement in nutritional status and kidney disease of CKD patients after undergoing thyroid hormone replacement (THR) therapy as therapeutic models. The included 156 CKD patients in stage III-IV were divided into the CKD stage III group (CKD-III group) (n = 80) and CKD stage IV group (CKD-IV group) (n = 76), and the clinical indicators of all the patients were collected. Based on changes in thyroid function, the included patients were again divided into the following groups: subclinical hypothyroidism group (the experimental group, hereinafter referred to Y-group, n = 78) and non-subclinical hypothyroidism group (the control group, hereinafter referred to N-group, n = 78), in which the CKD-III group was divided into CKD-IIIN group (n = 38) and CKD-IIIY group (n = 42), and also the CKD-IV group was divided into CKD-IVN group (n = 40) and CKD-IVY group (n = 36). At the beginning, patients in the Y-group was orally given 25 μg/dL of levothyroxine; based on the progression of the disease, the dosage was regulated; the concentration of serum thyroid stimulating hormone (TSH) was assessed once per month, as well as changes in tri-iodothyronine (T3) and tetraiodothyronine (T4). Estimated glomerular filtration rate (eGFR) in the CKD-IIIY group was significantly changed compared with that of the CKD-IVY group after THR therapy. Comparison of nutrition-based indicators between the N-group and the Y-group showed that the serum albumin (ALB) level, the hemoglobin (HGB) level, and the grip strength of both the left and right hand were notably decreased (P < 0.05). After THR therapy, the indicators related to CKD patients were accompanied by subclinical hypothyroidism changes; the levels of ALB and HGB, as well as the grip strength of both the left and right hand were notably increased compared with before undergoing THR therapy (P < 0.05). In conclusion, malnutrition of chronic kidney disease caused by subclinical hypothyroidism could be partially recovered after THR therapy as therapeutic models.",2019,Estimated glomerular filtration rate (eGFR) in the CKD-IIIY group was significantly changed compared with that of the CKD-IVY group after THR therapy.,"['156 CKD patients in stage III-IV', 'patients with chronic kidney disease (CKD) at stage III-IV accompanied by hypothyroidism', 'CKD patients after undergoing', 'patients with chronic kidney disease accompanied by hypothyroidism taking thyroid hormone replacement therapy as the therapeutic models']","['subclinical hypothyroidism group (the experimental group, hereinafter referred to Y-group, n\u202f=\u202f78) and non-subclinical hypothyroidism group (the control group, hereinafter referred to N-group, n\u202f=\u202f78), in which the CKD-III group was divided into CKD-IIIN group (n\u202f=\u202f38) and CKD-IIIY group', 'levothyroxine', 'thyroid hormone replacement (THR) therapy']","['subclinical hypothyroidism changes; the levels of ALB and HGB', 'Estimated glomerular filtration rate (eGFR', 'concentration of serum thyroid stimulating hormone (TSH', 'serum albumin (ALB) level, the hemoglobin (HGB) level, and the grip strength of both the left and right hand', 'grip strength of both the left and right hand']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C2609422', 'cui_str': 'Hypothyroidism (SMQ)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C2242640', 'cui_str': 'Thyroid hormone replacement therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}, {'cui': 'C2242640', 'cui_str': 'Thyroid hormone replacement therapy'}]","[{'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0912730', 'cui_str': 'aluminum boride'}, {'cui': 'C3811844'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0857986', 'cui_str': 'Serum thyroid stimulating hormone'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}]",156.0,0.0121225,Estimated glomerular filtration rate (eGFR) in the CKD-IIIY group was significantly changed compared with that of the CKD-IVY group after THR therapy.,"[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Department of Clinical Nutrition, Chongqing Traditional Chinese Medicine Hospital, Chongqing City 400021, China.'}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Endocrinology, Chongqing Traditional Chinese Medicine Hospital, Chongqing City 400021, China.'}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Endocrinology, Chongqing Traditional Chinese Medicine Hospital, Chongqing City 400021, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Department of Endocrinology, Chongqing Traditional Chinese Medicine Hospital, Chongqing City 400021, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'Department of Endocrinology, Chongqing Traditional Chinese Medicine Hospital, Chongqing City 400021, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2019.09.023']
1164,31889803,The clinical effect of Prednisone in combination with Mycophenolate mofetil on idiopathic thrombocytopenic purpura (ITP) and its influence on the level of peripheral blood T lymphocytes and NK lymphocytes.,"Objective


To explore he curative effect and safety of Prednisone in combination with Mycophenolate in treating ITP and its influence on the level of peripheral blood T lymphocytes and NK lymphocytes.
Method


93 cases of ITP patients were divided into the observation group and the control group by the Random Number Table method, 48 cases for the observation group, 45 for another. Patients in the control group orally took 0.5 mg/kg Prednisone Acetate tablets daily, two times each in the morning and evening. And the observation group, based on the treatment of the control group, orally took Mycophenolate Mofetil Dispersible tablets twice a day, 1 g each time. According to patients' conditions, 3 to 5 courses were set for treatment with 3 weeks a course. Compared PLT amount and the changing situation of inflammatory factors, CD3 +  and CD3 + CD95L +  before and after the treatment, the level of CD3 + Caspase-3 +  and CD3 + Caspase-8 + , NK + , NK +  CD95L + , NK + Caspase-3 + , NK + Caspase-8, the curative effect and adverse events.
Result


After treatment, PLT amount in both groups increased, and the increase in the observation group was much higher than that of the control group, the difference had statistical significance ( P  < 0.05). The time needed for PLT amount in the control group to reach the normal and peak values was longer than that of the observation group, whose PLT peak value was higher than another group. The difference had statistical significance ( P  < 0.05). After the treatment, the levels of TNF-α and IL-6 were lowered, and the value of the observation group was lower than that of another. The difference between and within the group has statistical significance. After the treatment, the level of CD3 + , CD3 + CD95L +  and CD3 + Caspase-8 +  is much higher and CD3 + Caspase-3 +  level lower than that before the treatment. The difference has statistical significance ( P  < 0.05). After the treatment, the level of NK +  and NK +  CD95L +  is higher and the level of NK + Caspase-8 +  lower than that before the treatment. The difference has statistical significance ( P  < 0.05). After the treatment, the total effective rate 91.67% of the observation group is much higher than that 75.56% of another. The difference has statistical significance ( P  < 0.05). After the treatment, the incidence rate of adverse events in the control group is 11.11% (5/45), while 4.17% (2/48) in the observation group. The difference between groups has statistical significance (χ 2  = 3.890,  P  < 0.05).
Conclusion


The curative effect of Prednisone in combination with Mycophenolate on ITP patients is better than orally taking Prednisone tablets. Moreover, when it comes to Prednisone in combination with Mycophenolate, both the PLT amount and immunocompetence are improved without much adverse reaction, and the molecules of peripheral blood T lymphocytes and NK lymphocytes can be effectively adjusted to relieve the symptoms. So the method is trustworthy to be popularized for clinical practices.",2019,"After the treatment, the levels of TNF-α and IL-6 were lowered, and the value of the observation group was lower than that of another.",['93 cases of ITP patients'],"['Prednisone', 'Mycophenolate Mofetil Dispersible tablets', 'control group orally took 0.5\u202fmg/kg Prednisone Acetate tablets', 'Mycophenolate', 'Mycophenolate mofetil']","['level of NK +  and NK +  CD95L ', 'levels of TNF-α and IL-6', 'PLT amount', 'total effective rate', 'idiopathic thrombocytopenic purpura (ITP', 'time needed for PLT amount', 'peripheral blood T lymphocytes and NK lymphocytes', 'level of CD3 + , CD3 + CD95L +  and CD3 + Caspase-8 ', 'PLT peak value', 'incidence rate of adverse events']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0021540', 'cui_str': 'ITP'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0253023', 'cui_str': 'Fas Ligand'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0398650', 'cui_str': 'Autoimmune Thrombocytopenia'}, {'cui': 'C0021540', 'cui_str': 'ITP'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0667830', 'cui_str': 'Mch5 Protease'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",93.0,0.0185579,"After the treatment, the levels of TNF-α and IL-6 were lowered, and the value of the observation group was lower than that of another.","[{'ForeName': 'Jiangwei', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Pediatrics, Department of Western Medicine, Central Hospital of Enshi Tujia and Miao Autonomous Prefecture, Enshi 445000, China.'}, {'ForeName': 'Gangzuo', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, Department of Western Medicine, Central Hospital of Enshi Tujia and Miao Autonomous Prefecture, Enshi 445000, China.'}, {'ForeName': 'Sihai', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Department of Pediatrics, Department of Western Medicine, Central Hospital of Enshi Tujia and Miao Autonomous Prefecture, Enshi 445000, China.'}, {'ForeName': 'Yirong', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'Department of Pediatrics, Department of Western Medicine, Central Hospital of Enshi Tujia and Miao Autonomous Prefecture, Enshi 445000, China.'}, {'ForeName': 'Jingzhen', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Pediatrics, Department of Western Medicine, Central Hospital of Enshi Tujia and Miao Autonomous Prefecture, Enshi 445000, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Department of Western Medicine, Central Hospital of Enshi Tujia and Miao Autonomous Prefecture, Enshi 445000, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Pediatrics, Department of Western Medicine, Central Hospital of Enshi Tujia and Miao Autonomous Prefecture, Enshi 445000, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2019.09.013']
1165,31889828,The beneficial effect of Indonesian propolis wax from  Tetragonula  sp. as a therapy in limited vaginal candidiasis patients.,"Vaginal candidiasis characterized by abnormal vaginal discharge and itching usually treated by azole's drug or nystatin; however, some results of treatment are unsatisfied and become recurrent. Propolis containing polyphenols and flavonoids is known to have anti-inflammatory and antimicrobial activity. This study investigated the effect of Indonesian propolis wax from  Tetragonula  sp. as a therapy in limited vaginal candidiasis patients. The subjects were women who came to the Tasik Community Health Centre met the inclusion criteria such as clinical complaint and laboratory evaluation (positive hyphae/pseudohyphae and culture on Sabouraud Dextrose Agar (SDA) medium) from a vaginal swab. Evaluation of anti-candida effect of propolis was determined by clinical remission and the absence of Candida's growth on SDA medium. Forty subjects were randomly assigned to those receiving treatment by ovule propolis (n = 20) and that treatment by nystatin (n = 20) as a control, once daily, for seven days, respectively. All methods have been approved by the Ethics Commission of the Faculty of Medicine, Universitas Indonesia. Our results indicated no significant difference in the laboratory evaluation of patients who have treated ovule propolis compared to standard therapy. This study suggests that propolis wax has a beneficial effect to develop as an anti-candida agent for vaginal candidiasis therapy.",2020,Our results indicated no significant difference in the laboratory evaluation of patients who have treated ovule propolis compared to standard therapy.,"['subjects were women who came to the Tasik Community Health Centre met the inclusion criteria such as clinical complaint and laboratory evaluation (positive hyphae/pseudohyphae and culture on Sabouraud Dextrose Agar (SDA) medium) from a vaginal swab', 'Forty subjects', 'limited vaginal candidiasis patients']","['Propolis containing polyphenols and flavonoids', 'nystatin']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205115', 'cui_str': 'Afferent (qualifier value)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0521057', 'cui_str': 'Hyphas'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C1720273', 'cui_str': 'Agar medium'}, {'cui': 'C0444207', 'cui_str': 'Vaginal swab (specimen)'}, {'cui': 'C0006852', 'cui_str': 'Vaginitis, Monilial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0596577', 'cui_str': 'Flavonoids'}, {'cui': 'C0028741', 'cui_str': 'Nystatin'}]",[],40.0,0.037539,Our results indicated no significant difference in the laboratory evaluation of patients who have treated ovule propolis compared to standard therapy.,"[{'ForeName': 'Siti', 'Initials': 'S', 'LastName': 'Farida', 'Affiliation': 'Department of Medical Pharmacy, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Muhamad', 'Initials': 'M', 'LastName': 'Sahlan', 'Affiliation': 'Department of Chemical Engineering, Faculty of Engineering, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Etin', 'Initials': 'E', 'LastName': 'Rohmatin', 'Affiliation': ""Department of Health Polytechnic Republic of Indonesia's Health Ministry Tasikmalaya, West Java, Indonesia.""}, {'ForeName': 'Robiatul', 'Initials': 'R', 'LastName': 'Adawiyah', 'Affiliation': 'Research Centre for Biomedical Engineering, Faculty of Engineering, Universitas Indonesia, UI Depok, Indonesia.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2019.06.010']
1166,31753694,Is the thought-action repertoire a viable intervention target in substance use populations?,"OBJECTIVE


This study examined if general population findings of positive correlations between happiness and breadth of thought-action repertoire (TAR) hold in substance use populations, and tests if the TAR is a modifiable intervention target.
METHODS


Using data from a randomized online survey on 468 adults in recovery from problematic substance use, we compared 5 happiness exercises to two control exercises on participants' post-exercise TAR, as measured by Frederickson's Modified Open-Ended Twenty Statements Test (MOETST) and coded specifically for action tendencies.
RESULTS


A negative binomial regression model indicated that momentary happiness reported before exercise completion was significantly and positively related to the breadth of action tendency repertoires (exp(b) = 1.05, exp(95% CI) [1.01, 1.09], p = 0.012). Two of five happiness exercises were associated with higher action tendency scores compared to the ""Three Hard Things"" control condition (""Savoring"": exp(b) [95% CI]: 1.51 [1.10, 2.09], X 2 (df = 1) = 6.36, adj. p = 0.038; ""Rose, Thorn, Bud"": 1.50 [1.09, 2.06], X 2 (df = 1) = 6.19, adj. p = 0.038). None were significantly different from a neutral control. Effects were not significant for MOETST raw scores.
CONCLUSIONS


Results indicate that momentary happiness is associated with broadened action tendencies among individuals in recovery. Brief, self-administered happiness exercises can successfully broaden this aspect of the thought-action repertoire in this population.",2019,"Two of five happiness exercises were associated with higher action tendency scores compared to the ""Three Hard Things"" control condition (""Savoring"": exp(b) [95% CI]: 1.51 [1.10, 2.09], X 2 (df = 1) = 6.36, adj.",['468 adults in recovery from problematic substance use'],"[""5 happiness exercises to two control exercises on participants' post-exercise TAR, as measured by Frederickson's Modified Open-Ended Twenty Statements Test (MOETST) and coded specifically for action tendencies""]","['higher action tendency scores', 'breadth of action tendency repertoires']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]","[{'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C3887664', 'cui_str': 'Tars, topical antipsoriatics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",20.0,0.0401,"Two of five happiness exercises were associated with higher action tendency scores compared to the ""Three Hard Things"" control condition (""Savoring"": exp(b) [95% CI]: 1.51 [1.10, 2.09], X 2 (df = 1) = 6.36, adj.","[{'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Hoeppner', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, 151 Merrimac Street, 6th Floor, Boston, MA 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA.'}, {'ForeName': 'Hannah A', 'Initials': 'HA', 'LastName': 'Carlon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, 151 Merrimac Street, 6th Floor, Boston, MA 02114, USA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Lambert', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, 151 Merrimac Street, 6th Floor, Boston, MA 02114, USA.'}, {'ForeName': 'Bettina B', 'Initials': 'BB', 'LastName': 'Hoeppner', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, 151 Merrimac Street, 6th Floor, Boston, MA 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA. Electronic address: bhoeppner@mgh.harvard.edu.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2019.06.006']
1167,31743602,Factors associated with the glucose-lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials.,"AIMS/INTRODUCTION


To explore the factors associated with the glucose-lowering efficacy of sitagliptin treatment in Japanese patients with type 2 diabetes mellitus.
MATERIALS AND METHODS


This was a post-hoc analysis of pooled data from seven sitagliptin phase II and III clinical studies carried out in Japan. All studies were double-blind, randomized, placebo-controlled, parallel-group and of 12-week duration. The analysis population consisted of 1,075 type 2 diabetes mellitus patients. In two of the trials, sitagliptin 50 mg and/or 100 mg daily were used as monotherapy; in five others, sitagliptin 50 mg daily was used as add-on treatment to ongoing pioglitazone, glimepiride, metformin, voglibose or glinides. Efficacy (reduction in hemoglobin A1c [HbA1c]) was evaluated in 12 sets of subgroups defined by demographic, glycemic, pancreatic β-cell function and insulin resistance parameters. An analysis of covariance model was used to evaluate the interaction between each parameter and efficacy.
RESULTS


Sitagliptin consistently provided a clinically meaningful reduction in HbA1c relative to placebo across all subgroups. Within subgroups, a greater absolute HbA1c reduction was associated with higher baseline HbA1c, fasting plasma glucose and 2-h post-meal glucose. Lower β-cell function, represented by homeostatic model assessment of β-cell function and insulinogenic index, was also associated with greater HbA1c reduction. In contrast, age, sex, body mass index, duration of type 2 diabetes mellitus and insulin resistance-related parameters did not interact with HbA1c changes.
CONCLUSIONS


Sitagliptin treatment was associated with clinically meaningful improvement in glycemic control in all subgroups of Japanese patients with type 2 diabetes mellitus that were evaluated. Higher baseline glycemic status and lower baseline β-cell function were identified as factors associated with greater HbA1c reduction after sitagliptin treatment.",2020,"Lower β-cell function, represented by HOMA-β and insulinogenic index, was also associated with greater HbA1c reduction.","['Japanese patients with type 2 diabetes mellitus', 'Japanese patients with type 2 diabetes mellitus (T2DM', '1,075 T2DM patients', 'pooled data from seven sitagliptin phase II and III clinical studies conducted in Japan', 'Japanese patients with T2DM evaluated']","['sitagliptin', 'sitagliptin 50 mg', 'placebo', 'sitagliptin treatment', 'pioglitazone, glimepiride, metformin, voglibose or glinides']","['fasting plasma glucose and 2-hour post-meal glucose', 'HOMA-β and insulinogenic index', 'Lower β-cell function', 'Efficacy (reduction in hemoglobin A1c [HbA1c']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1812992', 'cui_str': 'sitagliptin 50 MG [Januvia]'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0532578', 'cui_str': '3,4-dideoxy-4-((2-hydroxy-1-(hydroxymethyl)ethyl)amino)-2-C-(hydroxymethyl)-D-epi-inositol'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",1075.0,0.0213642,"Lower β-cell function, represented by HOMA-β and insulinogenic index, was also associated with greater HbA1c reduction.","[{'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Tajima', 'Affiliation': 'Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Jun-Ichi', 'Initials': 'JI', 'LastName': 'Eiki', 'Affiliation': 'Medical Affairs, and Japan Development, MSD K.K., Tokyo, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': 'Medical Affairs, and Japan Development, MSD K.K., Tokyo, Japan.'}, {'ForeName': 'Kotoba', 'Initials': 'K', 'LastName': 'Okuyama', 'Affiliation': 'Medical Affairs, and Japan Development, MSD K.K., Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Kawashima', 'Affiliation': 'Medical Affairs, ONO Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Engel', 'Affiliation': 'Clinical Research, Merck & Co., Inc, Kenilworth, New Jersey, USA.'}]",Journal of diabetes investigation,['10.1111/jdi.13182']
1168,31070954,Water deprivation does not augment sympathetic or pressor responses to sciatic afferent nerve stimulation in rats or to static exercise in humans.,"Excess dietary salt intake excites central sympathetic networks, which may be related to plasma hypernatremia. Plasma hypernatremia also occurs following water deprivation (WD). The purpose of this study was to test the hypothesis that WD induces hypernatremia and consequently augments sympathetic and pressor responses to sympathoexcitatory stimuli in rats and humans. Sympathetic nerve activity (SNA) and arterial blood pressure (ABP) responses to sciatic afferent nerve stimulation (2-20 Hz) and chemical stimulation of the rostral ventrolateral medulla (RVLM) were assessed in rats after 48 h of WD and compared with normally hydrated control rats (CON). In a parallel randomized-crossover human experiment ( n  = 13 healthy young adults), sympathetic (microneurography) and pressor (photoplethysmography) responses to static exercise were compared between 16-h WD and CON conditions. In rats, plasma [Na + ] was significantly higher in WD versus CON [136 ± 2 vs. 144 ± 2 (SD) mM,  P  < 0.01], but sciatic afferent nerve stimulation produced similar increases in renal SNA [5 Hz, 174 ± 34 vs. 169 ± 49% (SD),  n  = 6-8] and mean ABP [5 Hz, 21 ± 6 vs. 18 ± 7 (SD mmHg,  n  = 6-8]. RVLM injection of l-glutamate also produced similar increases in SNA and ABP in WD versus CON rats. In humans, WD increased serum [Na + ] [140.6 ± 2.1 vs. 142.1 ± 1.9 mM (SD),  P  = 0.02] but did not augment sympathetic [muscle SNA: change from baseline (Δ) 6 ± 7 vs. 5 ± 7 (SD) bursts/min,  P  = 0.83] or mean ABP [Δ 12 ± 5 vs. 11 ± 8 (SD) mmHg,  P  = 0.73; WD vs. CON for all results] responses during the final minute of exercise. These findings suggest that despite eliciting relative hypernatremia, WD does not augment sympathetic or pressor responses to sciatic afferent stimulation in rats or to static exercise in humans.  NEW & NOTEWORTHY  Excess dietary salt intake excites central sympathetic networks, which may be related to plasma hypernatremia. Plasma hypernatremia also occurs following water deprivation (WD). We sought to determine whether plasma hypernatremia/hyperosmolality induced by WD augments sympathetic and pressor responses to sympathoexcitatory stimuli. Our findings suggest that WD does not augment sympathetic or pressor responses to sciatic afferent nerve stimulation in rats or to static exercise in humans.",2019,"In rats, plasma [Na + ] was significantly higher in WD versus CON (136±2 vs. 144±2 mM, p<0.01), but sciatic afferent nerve stimulation produced similar increases in renal SNA (5Hz, 174±34 vs. 169±49%, n=6-8) and mean ABP (5Hz, 21±6","['rats or to static exercise in humans', 'rats after 48h of WD and compared to normally hydrated control rats (CON', 'n=13 healthy young adults']","['sympathetic (microneurography) and pressor (photoplethysmography) responses to static exercise', 'CON', 'sciatic afferent nerve stimulation (2-20 Hz) and chemical stimulation of the rostral ventrolateral medulla (RVLM']","['serum [Na + ', 'Sympathetic nerve activity (SNA) and arterial blood pressure (ABP) responses', 'plasma [Na + ', 'renal SNA', 'SNA and ABP', 'mean ABP']","[{'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205115', 'cui_str': 'Afferent (qualifier value)'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0038337', 'cui_str': 'Stimulation, Chemical'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",13.0,0.0954453,"In rats, plasma [Na + ] was significantly higher in WD versus CON (136±2 vs. 144±2 mM, p<0.01), but sciatic afferent nerve stimulation produced similar increases in renal SNA (5Hz, 174±34 vs. 169±49%, n=6-8) and mean ABP (5Hz, 21±6","[{'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Wenner', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Stocker', 'Affiliation': 'Department of Medicine, University of Pittsburgh , Pittsburgh, Pennsylvania.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00005.2019']
1169,31814316,Effects of walking on sundown syndrome in community-dwelling people with Alzheimer's disease.,"BACKGROUND


Sundown syndrome is an important care issue for people with dementia (PwD) and for family caregivers. Walking is a safe and simple physical activity for most PwD, yet no research has explored the effects of different long-term walking periods on sundown syndrome.
OBJECTIVES


This study aimed to determine the effects of walking on sundown syndrome, and to identify whether different walking time periods would show different effects on sundown syndrome in community-dwelling people with Alzheimer's disease.
METHODS


A quasi-experimental designed study with repeated measurements was conducted. Sixty PwD were recruited and assigned to either the control group or the morning or afternoon walking group according to their caregiver's preference. The participants in the two walking groups completed an average of 120-min walking per week, accompanied by their caregivers. Forty-six achieved the 6-month intervention. Four measurements were taken, one at the pretest and one at weeks 8, 16 and 24. The Chinese version of the Cohen-Mansfield Agitation Inventory, community form (C-CMAI) was used to assess the severity of the sundown syndrome. The generalised estimating equation (GEE) was applied for the longitudinal data analysis.
RESULTS


There was a significant change across the study period (p = .048) in the morning walking group, indicating that the score for sundown syndrome decreased when PwD walked in the morning. Considering group effects, compared to the control group, the C-CMAI scores significantly decreased after 16 weeks of walking in the afternoon walking group (p = .001) and after 24 weeks in both the morning and afternoon walking groups (p = .001), indicating that after PwD had walked for 16 weeks, sundown syndrome ameliorated in the afternoon group and continually decreased after 24 weeks in both the morning and afternoon groups. However, there was no significant group difference between the morning and afternoon walking groups during the 24-week walking intervention.
CONCLUSIONS


The results indicated that both morning walking and afternoon walking are beneficial for ameliorating the symptoms of sundown syndrome; however, walking in the afternoon may have a faster effect on the symptoms than walking in the morning. Walking is a safe, simple, feasible and effective intervention to benefit individuals with sundown syndrome.
IMPLICATIONS FOR PRACTICE


Regularly walking for 30 min a day, four times a week, is beneficial to alleviate sundown syndrome among PwD living in the community. Either morning or afternoon walking is effective for decreasing sundown syndrome, and the longer the walking time, the greater the impact on sundown syndrome.",2020,"Considering group effects, compared to the control group, the C-CMAI scores significantly decreased after 16 weeks of walking in the afternoon walking group (p = .001) and after 24 weeks in both the morning and afternoon walking groups (p = .001), indicating that after PwD had walked for 16 weeks, sundown syndrome ameliorated in the afternoon group and continually decreased after 24 weeks in both the morning and afternoon groups.","[""community-dwelling people with Alzheimer's disease"", 'Sixty PwD', 'people with dementia (PwD) and for family caregivers']","[""control group or the morning or afternoon walking group according to their caregiver's preference"", 'afternoon walking']","['sundown syndrome', 'C-CMAI scores']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]","[{'cui': 'C1142436', 'cui_str': 'Sundowning (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0219769,"Considering group effects, compared to the control group, the C-CMAI scores significantly decreased after 16 weeks of walking in the afternoon walking group (p = .001) and after 24 weeks in both the morning and afternoon walking groups (p = .001), indicating that after PwD had walked for 16 weeks, sundown syndrome ameliorated in the afternoon group and continually decreased after 24 weeks in both the morning and afternoon groups.","[{'ForeName': 'Yen-Hua', 'Initials': 'YH', 'LastName': 'Shih', 'Affiliation': 'Department of Nursing, MeiHo University, Pingtung, Taiwan ROC.'}, {'ForeName': 'Ming-Chyi', 'Initials': 'MC', 'LastName': 'Pai', 'Affiliation': 'Division of Behavioral Neurology, Department of Neurology, College of Medicine, National Cheng Kung University, Tainan, Taiwan ROC.'}, {'ForeName': 'Huey-Shyan', 'Initials': 'HS', 'LastName': 'Lin', 'Affiliation': 'Department of Health-Business Administration, Fooyin University, Kaohsiung, Taiwan ROC.'}, {'ForeName': 'Pi-Shan', 'Initials': 'PS', 'LastName': 'Sung', 'Affiliation': 'Department of Neurology, College of Medicine, National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan ROC.'}, {'ForeName': 'Jing-Jy', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, National Cheng Kung University, Tainan, Taiwan ROC.'}]",International journal of older people nursing,['10.1111/opn.12292']
1170,31831044,An effective snakebite first aid training method for medics in the Chinese troops: a RCT.,"BACKGROUND


Snakebites can lead to lifelong consequences and is one of the main causes of death among military troops worldwide. However, few Chinese military medics know the proper first aid procedures for snakebites. Therefore, this study aimed to explore the impact of the Standard Operation Procedure (SOP) and checklist on Chinese military medics' ability to manage snakebite first aid.
METHODS


This study was a prospective single-blind randomized controlled trial conducted in a military medical university of China from May to June 2017. A questionnaire-based survey was performed to collect the participants' socio-demographic profiles before the baseline measurement. During the baseline measurement, participants were requested to provide corresponding first aid that was responsive to the simulative situation portrayed by the SPs (standardized patients) and the evaluators then scored their performances according to a checklist for snakebite first aid scoring table. After the baseline measurement, they were randomly assigned to one of three intervention groups after stratification according to their baseline performance scores: group A received a self-learning course with textbooks (n = 27), group B received a self-learning training on the SOP and checklist (n = 27) and group C was engaged in an interactive discussion panel regarding the SOP and checklist (n = 26). After the interventions, participants received outcome measurements about snakebite first aid key points capability from the same evaluator and SP for each group to avoid observational error. The reviewers were blinded about the grouping in the trial.
RESULTS


The baseline measurement yielded no significant difference (H = 1.647, P = 0.439) among the three groups. The post-intervention scores were higher than the pre-intervention scores for all three (A, B and C) groups (P = 0.008, P < 0.001 and P < 0.001, respectively). There was significant difference of the post-intervention scores among the three groups (F = 8.841, P < 0.001). Both post-intervention scores of group B and group C were higher than that of group A (P < 0.001 and P = 0.001, respectively), but no difference was found between group B and C (P = 0.695). The acceptance questionnaire score of SOP and checklist was mostly very satisfied, as the final scores of group B and group C were 4.62 ± 0.61 and 4.82 ± 0.45, respectively.
CONCLUSIONS


In this study, the implementation of an SOP and checklist for snakebite first aid was shown to update and improve first aid treatment concepts in military medics. These intervention methods played an important role in improving the medics' cognition and understanding of snakebite first aid. Therefore, this finding suggests that SOP and checklist training should be further implemented in Chinese troops for snakebite care.",2019,"The post-intervention scores were higher than the pre-intervention scores for all three (A, B and C) groups (P = 0.008, P < 0.001 and P < 0.001, respectively).",['military medical university of China from May to June 2017'],"['self-learning course with textbooks (n\u2009=\u200927), group B received a self-learning training on the SOP and checklist (n\u2009=\u200927) and group C was engaged in an interactive discussion panel regarding the SOP and checklist', 'Standard Operation Procedure (SOP']","['post-intervention scores', 'acceptance questionnaire score of SOP and checklist']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",,0.0266362,"The post-intervention scores were higher than the pre-intervention scores for all three (A, B and C) groups (P = 0.008, P < 0.001 and P < 0.001, respectively).","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Qiu', 'Affiliation': 'First Medical Center, General Hospital of the PLA, Beijing, 100853, China.'}, {'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Qiu', 'Affiliation': 'Second Medical Center, General Hospital of the PLA, Beijing, 100853, China.'}, {'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Nursing, School of Nursing, Naval Medical University, Shanghai, 200433, China.'}, {'ForeName': 'Yi-Xin', 'Initials': 'YX', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency Nursing, School of Nursing, Naval Medical University, Shanghai, 200433, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gui', 'Affiliation': 'Department of Emergency Nursing, School of Nursing, Naval Medical University, Shanghai, 200433, China. guili2000@foxmail.com.'}]",Military Medical Research,['10.1186/s40779-019-0230-9']
1171,31797987,Early life cognitive development trajectories and intelligence quotient in middle childhood and early adolescence in rural western China.,"The relationship of cognitive developmental trajectories during the dynamic first years with later life development outcomes remains unclear in low- and middle-income countries. 1388 Children born to women who participated in a randomized trial of antenatal micronutrient supplementation in rural China were prospectively followed. Cognitive development was assessed six times between 3 and 30 months of age using Bayley Scales of Infant Development, and then in mid-childhood (7-9 years) and early adolescence (10-12 years) using Wechsler Intelligence Scale for Children. We identified four distinct infant cognitive development trajectory subgroups using group-based trajectory modeling: (i) consistently above average, (ii) consistently average, (iii) started below average and then improved, and (iv) started below average and then declined. LBW infants (<2500 g) were 10.60 times (95% CI 3.57, 31.49) more likely to be in the trajectory group that started below average and then declined, while each grade increase in maternal education decreased the risk of being in this group by 73% (95% CI 54%, 84%). Infants who performed consistently above average had 8.02 (95% CI 1.46, 14.59) points higher IQ in adolescence versus the declining trajectory group. These findings suggest that interventions to improve early child development trajectories may produce long-term human capital benefits.",2019,"LBW infants (<2500 g) were 10.60 times (95% CI 3.57, 31.49) more likely to be in the trajectory group that started below average and then declined, while each grade increase in maternal education decreased the risk of being in this group by 73% (95% CI 54%, 84%).","['middle childhood and early adolescence in rural western China', '1388 Children born to women who participated']",['antenatal micronutrient supplementation'],"['Cognitive development', 'maternal education']","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",1388.0,0.0300938,"LBW infants (<2500 g) were 10.60 times (95% CI 3.57, 31.49) more likely to be in the trajectory group that started below average and then declined, while each grade increase in maternal education decreased the risk of being in this group by 73% (95% CI 54%, 84%).","[{'ForeName': 'Zhonghai', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China.""}, {'ForeName': 'Suying', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': ""United Nations Children's Fund, China Office, Beijing, 100600, P.R. China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Department of Nutrition and Food Safety Research, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Qi', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China.""}, {'ForeName': 'Shaoru', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elhoumed', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dibley', 'Affiliation': 'School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Wafaie W', 'Initials': 'WW', 'LastName': 'Fawzi', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Lingxia', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China. tjzlx@mail.xjtu.edu.cn.""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Sudfeld', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",Scientific reports,['10.1038/s41598-019-54755-1']
1172,27280511,Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma.,"OBJECTIVE


To clarify the role of splenectomy in total gastrectomy for proximal gastric cancer.
BACKGROUNDS


Splenectomy in total gastrectomy is associated with increased operative morbidity and mortality, but its survival benefit is unclear. Previous randomized controlled trials were underpowered and inconclusive.
METHODS


We conducted a multiinstitutional randomized controlled trial. Proximal gastric adenocarcinoma of T2-4/N0-2/M0 not invading the greater curvature was eligible. During the operation, surgeons confirmed that R0 resection was possible with negative lavage cytology, and patients were randomly assigned to either splenectomy or spleen preservation. The primary endpoint was overall survival (OS) and the secondary endpoints were relapse-free survival, operative morbidity, operation time, and blood loss. The trial was designed to confirm noninferiority of spleen preservation to splenectomy in OS with a noninferiority margin of the hazard ratio as 1.21 and 1-sided alpha of 5%.
RESULTS


Between June 2002 and March 2009, 505 patients (254 splenectomy, 251 spleen preservation) were enrolled from 36 institutions. Splenectomy was associated with higher morbidity and larger blood loss, but the operation time was similar. The 5-year survivals were 75.1% and 76.4% in the splenectomy and spleen preservation groups, respectively. The hazard ratio was 0.88 (90.7%, confidence interval 0.67-1.16) (<1.21); thus, the noninferiority of spleen preservation was confirmed (P = 0.025).
CONCLUSIONS


In total gastrectomy for proximal gastric cancer that does not invade the greater curvature, splenectomy should be avoided as it increases operative morbidity without improving survival.",2017,"The hazard ratio was 0.88 (90.7%, confidence interval 0.67-1.16) (<1.21); thus, the noninferiority of spleen preservation was confirmed (P = 0.025).
","['total gastrectomy for proximal gastric cancer', 'Total Gastrectomy for Proximal Gastric Carcinoma', 'Between June 2002 and March 2009, 505 patients (254 splenectomy, 251 spleen preservation) were enrolled from 36 institutions']","['splenectomy or spleen preservation', 'splenectomy', 'Splenectomy']","['operative morbidity and mortality', '5-year survivals', 'operative morbidity', 'hazard ratio', 'relapse-free survival, operative morbidity, operation time, and blood loss', 'overall survival (OS', 'noninferiority of spleen preservation', 'higher morbidity and larger blood loss', 'Proximal gastric adenocarcinoma']","[{'cui': 'C0161899', 'cui_str': 'Total gastrectomy (procedure)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0699791', 'cui_str': 'Carcinoma of stomach (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]",505.0,0.160037,"The hazard ratio was 0.88 (90.7%, confidence interval 0.67-1.16) (<1.21); thus, the noninferiority of spleen preservation was confirmed (P = 0.025).
","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sano', 'Affiliation': '*Department of Surgery, Cancer Institute Hospital, Tokyo, Japan †Department of Surgery, Hyogo College of Medicine, Hyogo, Japan ‡Japan Clinical Oncology Group Data Center, National Cancer Center, Tokyo, Japan §Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan ¶Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan ||Department of Surgery, Niigata Cancer Center Hospital, Niigata, Japan **Department of Gastroenterological Surgery, Aichi Cancer Center, Nagoya, Japan ††Department of Surgery, Toyama Prefectural Central Hospital, Toyama City, Japan ‡‡Department of Surgery, Sakai City Medical Center, Sakai, Japan §§Department of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan ¶¶Department of Surgery, Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Sasako', 'Affiliation': ''}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': ''}, {'ForeName': 'Seiichiro', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': ''}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Katai', 'Affiliation': ''}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': ''}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nashimoto', 'Affiliation': ''}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': ''}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Kaji', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Imamura', 'Affiliation': ''}, {'ForeName': 'Norimasa', 'Initials': 'N', 'LastName': 'Fukushima', 'Affiliation': ''}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000001814']
1173,31395363,Predicting optimal interventions for clinical depression: Moderators of outcomes in a positive psychological intervention vs. cognitive-behavioral therapy.,"Identifying differences in the clinical response to specific interventions is an important challenge in the field of Clinical Psychology. This is especially true in the treatment of depression where many treatments appear to have comparable outcomes. In a controlled trial, we compared a positive psychology group intervention, the Integrative Positive Psychological Intervention for Depression (IPPI-D; n = 62) to a cognitive-behavioral therapy group intervention (CBT; n = 66) for depression. No statistically or clinically-significant differences between the treatments were found, but a slight advantage was observed, on average, for IPPI-D. The aim of the present study was to identify and combine moderators of the differential efficacy of these two psychological interventions for clinical depression. For this purpose, a secondary analysis using the Personalized Advantage Index (PAI) was performed to identify the intervention predicted to produce the better outcome for each patient. Six of the 21 potential moderators were found to predict differential efficacy between the treatments. IPPI-D was predicted to be the optimal treatment for 73% of the sample. Baseline features that characterized these individuals were: mental and physical comorbidity, prior antidepressant medication, higher levels of negative thoughts, and higher personal growth. The 27% who were predicted to achieve better outcomes in CBT than in IPPI-D tended to have these baseline features: no comorbidities, no prior antidepressant medication, lower levels of negative thoughts, and lower personal growth.",2019,"No statistically or clinically-significant differences between the treatments were found, but a slight advantage was observed, on average, for IPPI-D.",[],"['CBT', 'positive psychological intervention vs. cognitive-behavioral therapy', 'positive psychology group intervention, the Integrative Positive Psychological Intervention for Depression (IPPI-D; n\u202f=\u202f62) to a cognitive-behavioral therapy group intervention (CBT; n\u202f=\u202f66) for depression', 'psychological interventions']","['levels of negative thoughts, and lower personal growth', 'IPPI-D']",[],"[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1142075', 'cui_str': 'Negative thoughts'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.0159188,"No statistically or clinically-significant differences between the treatments were found, but a slight advantage was observed, on average, for IPPI-D.","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Lopez-Gomez', 'Affiliation': 'School of Health Sciences, Rey Juan Carlos University, Madrid, Spain. Electronic address: irene.lopez.gomez@urjc.es.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Lorenzo-Luaces', 'Affiliation': 'Department of Psychological and Brain Sciences, College of Arts & Sciences, Indiana University Bloomington, United States of America. Electronic address: lolorenz@indiana.edu.'}, {'ForeName': 'Covadonga', 'Initials': 'C', 'LastName': 'Chaves', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, Francisco de Vitoria University, Madrid, Spain. Electronic address: cchavesv@psi.ucm.es.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Hervas', 'Affiliation': 'Department of Clinical Psychology, School of Psychology, Complutense University of Madrid, Spain. Electronic address: ghervas@psi.ucm.es.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'DeRubeis', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, United States of America. Electronic address: derubeis@psych.upenn.edu.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Vazquez', 'Affiliation': 'Department of Clinical Psychology, School of Psychology, Complutense University of Madrid, Spain. Electronic address: cvazquez@psi.ucm.es.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2019.07.004']
1174,31881879,High-energy dose of therapeutic ultrasound in the treatment of patellar tendinopathy: protocol of a randomized placebo-controlled clinical trial.,"BACKGROUND


Patellar tendinopathy is an extremely debilitating condition and its treatment usually requires a combination of clinical approaches. Therapeutic ultrasound (TUS) is one of the most available electrophysical agent in rehabilitation settings; however, there is also a lack of high-quality studies that test different dosimetric aspects of TUS. Thus, the purpose of this study is to evaluate the short-, medium-, and long-term effects of the combination of high-energy TUS with a rehabilitation program for patellar tendinopathy.
METHODS


This will be a randomized, placebo-controlled trial with blinding of patients, assessors, and therapist. The setting is an outpatient physical therapy clinic. We will recruit 66 participants (male and female) aged between 18 and 40 years and presenting with patellar tendinopathy. A treatment combining high-energy dose TUS and a rehabilitation program for patellar tendinopathy will be delivered twice a week for 8 weeks. The control group will receive the same treatment, but with a placebo TUS. The effectiveness of the intervention will be measured at the beginning (baseline), midpoint (4 weeks), and end of treatment (8 weeks), as well as at 3- and 6-months post-treatment. Primary outcomes will be pain intensity (visual analogue scale, VAS), and VISA-P questionnaire and primary time points will be baseline (T0) and the end of the program (T2). Also, IPAQ-short form questionnaire, muscle strength (manual dynamometry), 2D kinematics, pain pressure threshold (PPT) algometry, thermography, and magnetic resonance imaging (MRI) will be collected.
DISCUSSION


TUS will be applied in an attempt to enhance the results obtained with the rehabilitation program proposed in this study, as well as stimulate some repair responses in individuals undergoing treatment for patellar tendinopathy, which in turn may optimize and improve treatment programs for patellar tendinopathy as well as to establish new guidelines for the application of TUS.
TRIAL REGISTRATION


This study was prospectively registered at April-3rd-2018 and updated at September-1st-2019 in the Brazilian Registry of Clinical Trials (REBEC) under the registration number: RBR-658n6w.",2019,"Also, IPAQ-short form questionnaire, muscle strength (manual dynamometry), 2D kinematics, pain pressure threshold (PPT) algometry, thermography, and magnetic resonance imaging (MRI) will be collected.
","['individuals undergoing treatment for patellar tendinopathy', 'patellar tendinopathy', '66 participants (male and female) aged between 18 and 40\u2009years and presenting with patellar tendinopathy']","['Therapeutic ultrasound (TUS', 'placebo TUS', 'placebo', 'high-energy TUS with a rehabilitation program', 'therapeutic ultrasound']","['IPAQ-short form questionnaire, muscle strength (manual dynamometry), 2D kinematics, pain pressure threshold (PPT) algometry, thermography, and magnetic resonance imaging (MRI', 'pain intensity (visual analogue scale, VAS), and VISA-P questionnaire and primary time points will be baseline (T0) and the end of the program (T2']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1568272', 'cui_str': 'Tendinopathy'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0041620', 'cui_str': 'Ultrasonic Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0039810', 'cui_str': 'Temperature Mapping'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",66.0,0.104925,"Also, IPAQ-short form questionnaire, muscle strength (manual dynamometry), 2D kinematics, pain pressure threshold (PPT) algometry, thermography, and magnetic resonance imaging (MRI) will be collected.
","[{'ForeName': 'Julio Fernandes', 'Initials': 'JF', 'LastName': 'de Jesus', 'Affiliation': 'Human Movement Science and Rehabilitation Postgraduate Program, Universidade Federal de São Paulo - UNIFESP, campus Baixada Santista, Santos, SP, 11015-029, Brazil. juliofernandes85@gmail.com.'}, {'ForeName': 'Tadeu Aldrovando Brihy', 'Initials': 'TAB', 'LastName': 'de Albuquerque', 'Affiliation': 'Functional Rehabilitation Specialized Group - GERF, São Paulo, SP, 01239-040, Brazil.'}, {'ForeName': 'Leandro Girardi', 'Initials': 'LG', 'LastName': 'Shimba', 'Affiliation': 'NANTEN Healthy and Orthopaedic Institute, São Paulo, SP, 01227-000, Brazil.'}, {'ForeName': 'Flavio Fernandes', 'Initials': 'FF', 'LastName': 'Bryk', 'Affiliation': 'Functional Rehabilitation Specialized Group - GERF, São Paulo, SP, 01239-040, Brazil.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, La Trobe University, Vic, Melbourne, 3086, Australia.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Pinfildi', 'Affiliation': 'Physical Agents and Rehabilitation Research Group GPRAE, Universidade Federal de São Paulo - UNIFESP, campus Baixada Santista, Santos, SP, 11015-029, Brazil.'}]",BMC musculoskeletal disorders,['10.1186/s12891-019-2993-2']
1175,31868149,The Effect of Nanocurcumin in Improvement of Knee Osteoarthritis: A Randomized Clinical Trial.,"OBJECTIVE


Osteoarthritis is a degenerative disease of the joints. Non-steroidal antiinflammatory drugs (NSAIDs) are being used for the treatment of osteoarthritis. However, their use is limited due to complications, such as gastrointestinal bleeding. Therefore, it is necessary to find alternative treatments for osteoarthritis. Recently, nanomicelle curcumin has been developed to increase the oral bioavailability of curcumin. The aim of this study was to evaluate the effect of nano curcumin on the alleviation of the symptoms of knee osteoarthritis patients.
METHODS


In this randomized, double-blind controlled trial, the intervention group was administered 40 mg of nanocurcumin capsule every 12 hours over a period of six weeks, and the control group received the placebo (similar components of nanomicelle curcumin capsules yet without curcumin). In the final analysis, 36 patients in the nanocurcumin group and 35 patients in the placebo group were enrolled. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was filled for patients in their first visit and at the end of six weeks. Differences were statistically significant at P-value < 0.05.
RESULTS


There were no significant differences between the two groups regarding gender, age, Kellgren score, and the duration of the disease before the intervention. A significant decrease was observed in the overall score, along with the scores of pain, stiffness and physical activity subscales of the WOMAC questionnaire in patients of the nano curcumin group compared with the placebo group.
CONCLUSION


Nanocurcumin significantly improves the symptoms of osteoarthritis patients.",2020,"A significant decrease was observed in the overall score, along with the scores of pain, stiffness and physical activity subscales of the WOMAC questionnaire in patients of the nanocurcumin group compared with the placebo group.
","['Knee Osteoarthritis', '36 patients in the nanocurcumin group and 35 patients in the placebo group were enrolled', 'knee osteoarthritis patients']","['nanocurcumin', 'Nanocurcumin', 'placebo', 'nanocurcumin capsule']","['overall score', 'scores of pain, stiffness and physical activity subscales of the WOMAC questionnaire']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.128762,"A significant decrease was observed in the overall score, along with the scores of pain, stiffness and physical activity subscales of the WOMAC questionnaire in patients of the nanocurcumin group compared with the placebo group.
","[{'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Hashemzadeh', 'Affiliation': 'Rheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Davoudian', 'Affiliation': 'Rheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mahmoud R', 'Initials': 'MR', 'LastName': 'Jaafari', 'Affiliation': 'Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mirfeizi', 'Affiliation': 'Rheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Current rheumatology reviews,['10.2174/1874471013666191223152658']
1176,31899035,Incidence of Macular Atrophy after Untreated Neovascular Age-Related Macular Degeneration: Age-Related Eye Disease Study Report 40.,"PURPOSE


To report the natural history of untreated neovascular age-related macular degeneration (nAMD) regarding subsequent macular atrophy.
DESIGN


Prospective cohort within a randomized, controlled trial of oral micronutrient supplements.
PARTICIPANTS


Age-Related Eye Disease Study (AREDS) participants (55-80 years) who demonstrated nAMD during follow-up (1992-2005), prior to anti-vascular endothelial growth factor (VEGF) therapy.
METHODS


Color fundus photographs were collected at annual study visits and graded centrally for late age-related macular degeneration (AMD). Incident macular atrophy after nAMD was examined by Kaplan-Meier analysis and proportional hazards regression.
MAIN OUTCOME MEASURES


Incident macular atrophy after nAMD.
RESULTS


Of the 4757 AREDS participants, 708 eyes (627 participants) demonstrated nAMD during follow-up and were eligible. The cumulative risks of incident macular atrophy after untreated nAMD were 9.6% (standard error, 1.2%), 31.4% (standard error, 2.2%), 43.1% (standard error, 2.6%), and 61.5% (standard error, 4.3%) at 2, 5, 7, and 10 years, respectively. This corresponded to a linear risk of 6.5% per year. The cumulative risk of central involvement was 30.4% (standard error, 3.2%), 43.4% (standard error, 3.8%), and 57.0% (standard error, 4.8%) at first appearance of atrophy, 2 years, and 5 years, respectively. Geographic atrophy (GA) in the fellow eye was associated with increased risk of macular atrophy (hazard ratio [HR], 1.70; 95% confidence interval [CI], 1.17-2.49; P = 0.006). However, higher 52-single nucleotide polymorphism AMD genetic risk score was not associated with increased risk of macular atrophy (HR, 1.03; 95% CI, 0.90-1.17; P = 0.67). Similarly, no significant differences were observed according to SNPs at CFH, ARMS2, or C3.
CONCLUSIONS


The rate of incident macular atrophy after untreated nAMD is relatively high, increasing linearly over time and affecting half of eyes by 8 years. Hence, factors other than anti-VEGF therapy are involved in atrophy development, including natural progression to GA. Comparison with studies of treated nAMD suggests it may not be necessary to invoke a large effect of anti-VEGF therapy on inciting macular atrophy, although a contribution remains possible. Central involvement is present in one third of eyes at the outset (similar to pure GA) and increases linearly to half at 3 years.",2020,"Geographic atrophy (GA) in the fellow eye was associated with increased risk of macular atrophy (hazard ratio [HR], 1.70; 95% confidence interval [CI], 1.17-2.49; P = 0.006).","['Of the 4757 AREDS participants, 708 eyes (627 participants) demonstrated nAMD during follow-up and were eligible', 'Macular Atrophy after Untreated Neovascular Age-Related Macular Degeneration', 'Color fundus photographs were collected at annual study visits and graded centrally for late age-related macular degeneration (AMD', 'Age-Related Eye Disease Study (AREDS) participants (55-80 years) who demonstrated nAMD during follow-up (1992-2005), prior to anti-vascular endothelial growth factor (VEGF) therapy']",['oral micronutrient supplements'],"['risk of macular atrophy', 'cumulative risk of central involvement', 'higher 52-single nucleotide polymorphism AMD genetic risk score', 'cumulative risks of incident macular atrophy', 'SNPs at CFH, ARMS2, or C3', 'rate of incident macular atrophy', 'Geographic atrophy (GA']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1288283', 'cui_str': 'Anetoderma'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0015397', 'cui_str': 'Eye Diseases'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1288283', 'cui_str': 'Anetoderma'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}]",627.0,0.0872275,"Geographic atrophy (GA) in the fellow eye was associated with increased risk of macular atrophy (hazard ratio [HR], 1.70; 95% confidence interval [CI], 1.17-2.49; P = 0.006).","[{'ForeName': 'Panos G', 'Initials': 'PG', 'LastName': 'Christakis', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Agrón', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Klein', 'Affiliation': 'Casey Eye Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'J Peter', 'Initials': 'JP', 'LastName': 'Campbell', 'Affiliation': 'Casey Eye Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Ferris', 'Affiliation': 'Ophthalmic Research Consultants, LLC, Waxhaw, North Carolina.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Tiarnan D', 'Initials': 'TD', 'LastName': 'Keenan', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: tiarnan.keenan@nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.11.016']
1177,31863040,To what extent do patients' racial characteristics affect our clinical decisions?,"Design The study employed a randomised controlled trial methodology and it was delivered electronically as a survey. Intervention Fifty-seven primary and secondary care dentists were randomised to two experimental groups. The participants in both groups assessed a vignette (clinical scenario, clinical photograph and radiograph) with the only difference between the vignettes in the two groups being the patient's race (skin colour: Black or White). The scenario was a case of a severely carious first lower molar with signs and symptoms of irreversible pulpitis.Outcome measures The dentists' clinical treatment decisions (recommendation of root canal treatment or extraction) were recorded. A previously validated Brief Implicit Association Test (BIAT) was used to measure implicit racial bias.Results A statistically significant difference in dentists' recommendations was observed. Recommendation of root canal treatment was greater for White patients (86.21%) compared to the Black patients (60.71%) and dentists were far more likely to recommend extraction in the Black patient group. The BIAT scores also indicated that pro-White unconscious racial bias was prevalent amongst the participants. Conclusion A patient's race may influence a dentist's decision whether to extract or retain a decayed tooth.",2019,Recommendation of root canal treatment was greater for White patients (86.21%) compared to the Black patients (60.71%) and dentists were far more likely to recommend extraction in the Black patient group.,"[""participants in both groups assessed a vignette (clinical scenario, clinical photograph and radiograph) with the only difference between the vignettes in the two groups being the patient's race (skin colour: Black or White"", 'Intervention Fifty-seven primary and secondary care dentists']",[],"[""dentists' clinical treatment decisions (recommendation of root canal treatment or extraction"", 'Recommendation of root canal treatment']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}]",[],"[{'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]",57.0,0.0548822,Recommendation of root canal treatment was greater for White patients (86.21%) compared to the Black patients (60.71%) and dentists were far more likely to recommend extraction in the Black patient group.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Plessas', 'Affiliation': 'Peninsula Dental School, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}]",Evidence-based dentistry,['10.1038/s41432-019-0062-1']
1178,31863044,Managing post endodontic treatment pain by eliminating occlusal contacts.,"Data sources Forty-four adult patients (32 female : 12 males) with irreversible pulpitis with periapical periodontitis on a mandibular posterior tooth, who were undergoing a two-visit endodontic treatment protocol, were randomly divided into two groups. The intervention group (n = 22) had occlusal surface reduced on the treated tooth and a control group (n = 22) did not.Data The primary outcome was pain intensity after endodontic treament, which was measured on a visual-analogue-scale (VAS). This was measured 6, 12, 24 and 48 hours after the first visit, and 6, then 12 hours after the second visit.The study also investigated the proportion of patients who took post-operative analgesic tablets.Results Pain intensity 12 hours after the first and second visits were statistically significantly lower in the intervention group compared to the control group. The proportion of patients who recorded taking analgesics was not significantly different between the two groups.Conclusions Occlusal reduction seems to reduce levels of post root- treatment pain in posterior mandibular teeth 12 hours postopertively, but otherwise makes little difference.",2019,Results Pain intensity 12 hours after the first and second visits were statistically significantly lower in the intervention group compared to the control group.,"['patients who took post-operative analgesic tablets', 'Data sources Forty-four adult patients (32 female : 12 males) with irreversible pulpitis with periapical periodontitis on a mandibular posterior tooth, who were undergoing a two-visit endodontic treatment protocol']",[],"['proportion of patients who recorded taking analgesics', 'occlusal surface', 'pain intensity after endodontic treament, which was measured on a visual-analogue-scale (VAS', 'Pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0011001', 'cui_str': 'Data Sources'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0399406', 'cui_str': 'Irreversible pulpitis'}, {'cui': 'C0031030', 'cui_str': 'Periodontitis, Apical'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0040808', 'cui_str': 'Treatment Protocols'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",44.0,0.0556824,Results Pain intensity 12 hours after the first and second visits were statistically significantly lower in the intervention group compared to the control group.,"[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Balevi', 'Affiliation': 'Private Practice\xa0805 West Broadway, Vancouver , BC, V5Z 1K1, Canada. drben@dentalben.com.'}]",Evidence-based dentistry,['10.1038/s41432-019-0055-0']
1179,31855785,Long-term effects of pulmonary rehabilitation on daily life physical activity of patients with stage IV sarcoidosis: A randomized controlled trial.,"INTRODUCTION


Pulmonary rehabilitation (PR) is known to improve exercise tolerance, mood, and quality of life in patients with chronic respiratory diseases. The aim of this work was to determine whether PR provides long-term benefits in increasing daily life physical activity in patients with chronic sarcoidosis.
METHODS


This randomized prospective study (registered ClinicalTrials.gov NCT02044939) of 38 patients with stage IV chronic sarcoidosis was performed between 2012 and 2016. Patients were assigned to participate in a 2-month PR program (n=20) or receive counseling (n=18). Assessments were performed at baseline, 2 months (end of the PR program), 6months, and 12months, and included daily life physical activity parameters (measured for 5 consecutive days), exercise tolerance, dyspnea, anxiety, depression, fatigue, and quality of life. The primary outcome was the 12-month change in time spent in activities above an estimated energy expenditure of 2.5metabolic equivalents (METs). Secondary daily life physical activity outcomes included number of steps per day, total daily energy expenditure, and total energy expenditure above 2.5METs.
RESULTS


The primary outcome did not differ between the two groups; mean between-group differences were -13.2min (95% confidence interval [CI]: -76.3 to 49.8) at 6 months and -18.1min (95% CI: -55.7 to 19.4) at 12months. Although PR had no effect on secondary daily life physical activity outcomes, it did significantly increase exercise tolerance at 6 and 12 months and decrease the dyspnea score at 6 months and the fatigue score at 12months.
CONCLUSION


This trial failed to demonstrate a beneficial effect of PR on daily life physical activity in sarcoidosis patients, suggesting that long-term behavioral programs may be necessary to complement PR.",2019,The primary outcome did not differ between the two groups; mean between-group differences were -13.2min,"['sarcoidosis patients', 'patients with stage IV sarcoidosis', '38 patients with stage IV chronic sarcoidosis was performed between 2012 and 2016', 'patients with chronic respiratory diseases', 'patients with chronic sarcoidosis']","['Pulmonary rehabilitation (PR', 'PR', 'pulmonary rehabilitation', 'PR program']","['secondary daily life physical activity outcomes', 'exercise tolerance', 'daily life physical activity parameters', 'number of steps per day, total daily energy expenditure, and total energy expenditure above 2.5METs', 'dyspnea score', 'exercise tolerance, dyspnea, anxiety, depression, fatigue, and quality of life', 'fatigue score', '12-month change in time spent in activities above an estimated energy expenditure of 2.5metabolic equivalents (METs', 'exercise tolerance, mood, and quality of life', 'daily life physical activity']","[{'cui': 'C0036202', 'cui_str': ""Boeck's Sarcoid""}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure (observable entity)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.178156,The primary outcome did not differ between the two groups; mean between-group differences were -13.2min,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Wallaert', 'Affiliation': 'CHU Lille, Service de Pneumologie et ImmunoAllergologie, Centre de Référence constitutif des Maladies Rares, Hôpital Calmette, 59037 Lille, France; University of Lille, 59000 Lille, France. Electronic address: bwallaert@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kyheng', 'Affiliation': 'University of Lille, CHU Lille, EA 2694-Santé publique: épidémiologie et qualité des soins, Department of Biostatistics, 59000 Lille, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'University of Lille, CHU Lille, EA 2694-Santé publique: épidémiologie et qualité des soins, Department of Biostatistics, 59000 Lille, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stelianides', 'Affiliation': 'Division of Pneumology, Bichat Hospital, Paris-Diderot University, 75877, Paris, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wemeau', 'Affiliation': 'CHU Lille, Service de Pneumologie et ImmunoAllergologie, Centre de Référence constitutif des Maladies Rares, Hôpital Calmette, 59037 Lille, France.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Grosbois', 'Affiliation': 'FormactionSanté, 59840 Pérenchies, France.'}]",Respiratory medicine and research,['10.1016/j.resmer.2019.10.003']
1180,31881390,Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers.,"BACKGROUND


Colorectal cancer (CRC) screening by annual fecal immunochemical test (FIT) is an accessible and cost-effective strategy to lower CRC incidence and mortality. However, this mode of screening depends on follow-up colonoscopy after a positive FIT result. Unfortunately, nearly one-half of FIT-positive patients fail to complete this essential screening component. Patient navigation may improve follow-up colonoscopy adherence. To deliver patient navigation cost-effectively, health centers could target navigation to patients who are unlikely to complete the procedure on their own.
OBJECTIVES


The Predicting and Addressing Colonoscopy Non-adherence in Community Settings (PRECISE) clinical trial will validate a risk model of follow-up colonoscopy adherence and test whether patient navigation raises rates of colonoscopy adherence overall and among patients in each probability stratum (low, moderate, and high probability of adherence without intervention).
METHODS


PRECISE is a collaboration with a large community health center whose patient population is 37% Latino. Eligible patients will be aged 50-75, have an abnormal FIT result in the past month, and be due for a follow-up colonoscopy. Patients will be randomized to patient navigation or usual care. Primary outcomes will be colonoscopy completion within one year of a positive FIT result, cost, and cost-effectiveness. Secondary outcomes will include time to colonoscopy receipt, adequacy of bowel prep, and communication of results to primary care providers. Primary and secondary outcomes will be reported overall and by probability stratum.
DISCUSSION


This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers.
TRIAL REGISTRATION


National Clinical Trial (NCT) Identifier: NCT03925883.",2020,"This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers.
","['collaboration with a large community health center whose patient population is 37% Latino', 'community health centers', 'Eligible patients will be aged 50-75, have an abnormal FIT result in the past month, and be due for a follow-up colonoscopy']","['targeted navigation program', 'precision health intervention', 'patient navigation or usual care']","['overall and by probability stratum', 'time to colonoscopy receipt, adequacy of bowel prep, and communication of results to primary care providers', 'colonoscopy completion within one year of a positive FIT result, cost, and cost-effectiveness']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.111953,"This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers.
","[{'ForeName': 'Gloria D', 'Initials': 'GD', 'LastName': 'Coronado', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA. Electronic address: Gloria.D.Coronado@kpchr.org.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Johnson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Schneider', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Mummadi', 'Affiliation': 'Northwest Permanente Medical Group, Portland, OR, USA.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Petrik', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Jamie H', 'Initials': 'JH', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Jimenez', 'Affiliation': 'Sea Mar Community Health Centers, Seattle, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105920']
1181,31836722,Discovery of increased epidermal DNAH10 expression after regeneration of dermis in a randomized with-in person trial - reflections on psoriatic inflammation.,"Because molecular memories of past inflammatory events can persist in epidermal cells, we evaluated the long-term epidermal protein expression landscapes after dermal regeneration and in psoriatic inflammation. We first characterized the effects of two dermal regeneration strategies on transplants of indicator split-thickness skin grafts (STSGs) in ten adult patients with deep burns covering more than 20% of their body surface area. After fascial excision, three adjacent areas within the wound were randomized to receive a permanent dermal matrix, a temporary granulation-tissue-inducing dressing or no dermal component as control. Control areas were covered with STSG immediately, and treated areas after two-weeks of dermis formation. Epidermis-dermis-targeted proteomics of one-year-follow-up samples were performed for protein expression profiling. Epidermal expression of axonemal dynein heavy chain 10 (DNAH10) was increased 20-fold in samples having had regenerating dermis vs control. Given the dermal inflammatory component found in our dermal regeneration samples as well as in early psoriatic lesions, we hypothesized that DNAH10 protein expression also would be affected in psoriatic skin samples. We discovered increased DNAH10 expression in inflammatory lesions when compared to unaffected skin. Our results associate DNAH10 expression with cell proliferation and inflammation as well as with the epidermal memory resulting from the previous regenerative signals of dermis. This study (ISRCTN14499986) was funded by the Finnish Ministry of Defense and by government subsidies for medical research.",2019,Epidermal expression of axonemal dynein heavy chain 10 (DNAH10) was increased 20-fold in samples having had regenerating dermis vs control.,['ten adult patients with deep burns covering more than 20% of their body surface area'],"['dermal regeneration strategies', 'permanent dermal matrix, a temporary granulation-tissue-inducing dressing or no dermal component as control']","['Epidermal expression of axonemal dynein heavy chain 10 (DNAH10', 'DNAH10 expression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}]","[{'cui': 'C0349676', 'cui_str': 'Regeneration - action (qualifier value)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0018180', 'cui_str': 'Granulation Tissue'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1180333', 'cui_str': 'Axonemal Dyneins'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]",,0.0204012,Epidermal expression of axonemal dynein heavy chain 10 (DNAH10) was increased 20-fold in samples having had regenerating dermis vs control.,"[{'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Lagus', 'Affiliation': 'Helsinki Burn Centre, Department of Plastic Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Mariliis', 'Initials': 'M', 'LastName': 'Klaas', 'Affiliation': 'Department of Cell Biology, Institute of Molecular and Cell Biology, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Juteau', 'Affiliation': 'Department of Pathology, Haartman Institute, University of Helsinki and HUSLAB, Helsinki, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Elomaa', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Kere', 'Affiliation': 'Department of Biosciences and Nutrition, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Vuola', 'Affiliation': 'Helsinki Burn Centre, Department of Plastic Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Viljar', 'Initials': 'V', 'LastName': 'Jaks', 'Affiliation': 'Department of Cell Biology, Institute of Molecular and Cell Biology, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Esko', 'Initials': 'E', 'LastName': 'Kankuri', 'Affiliation': 'Faculty of Medicine, Department of Pharmacology, University of Helsinki, Helsinki, Finland. esko.kankuri@helsinki.fi.'}]",Scientific reports,['10.1038/s41598-019-53874-z']
1182,31844886,"Safety and efficacy of VB-111, an anticancer gene therapy, in patients with recurrent glioblastoma: results of a phase I/II study.","BACKGROUND


VB-111 is a non-replicating adenovirus carrying a Fas-chimera transgene, leading to targeted apoptosis of tumor vascular endothelium and induction of a tumor-specific immune response. This phase I/II study evaluated the safety, tolerability, and efficacy of VB-111 with and without bevacizumab in recurrent glioblastoma (rGBM).
METHODS


Patients with rGBM (n = 72) received VB-111 in 4 treatment groups: subtherapeutic (VB-111 dose escalation), limited exposure (LE; VB-111 monotherapy until progression), primed combination (VB-111 monotherapy continued upon progression with combination of bevacizumab), and unprimed combination (upfront combination of VB-111 and bevacizumab). The primary endpoint was median overall survival (OS). Secondary endpoints were safety, overall response rate, and progression-free survival (PFS).
RESULTS


VB-111 was well tolerated. The most common adverse event was transient mild-moderate fever. Median OS time was significantly longer in the primed combination group compared with both LE (414 vs 223 days; hazard ratio [HR], 0.48; P = 0.043) and unprimed combination (414 vs 141.5 days; HR, 0.24; P = 0.0056). Patients in the combination phase of the primed combination group had a median PFS time of 90 days compared with 60 in the LE group (HR, 0.36; P = 0.032), and 63 in the unprimed combination group (P = 0.72). Radiographic responders to VB-111 exhibited characteristic, expansive areas of necrosis in the areas of initial enhancing disease.
CONCLUSIONS


Patients with rGBM who were primed with VB-111 monotherapy that continued after progression with the addition of bevacizumab showed significant survival and PFS advantage, as well as specific imaging characteristics related to VB-111 mechanism of action. These results warrant further assessment in a randomized controlled study.",2020,"Median OS time was significantly longer in the Primed Combination group compared to both LE (414 vs 223 days; HR 0.48; p=0.043), and Unprimed Combination (414 vs. 141.5 days; HR 0.24; p=0.0056); Patients in the combination phase of the Primed Combination group had a median PFS time of 90 days compared to 60 in the LE group (HR 0.36; p=0.032), and 63 in the Unprimed Combination group (p=0.72).","['patients with recurrent glioblastoma', 'Patients with rGBM', 'Patients with rGBM (n=72) received', 'recurrent glioblastoma (rGBM']","['bevacizumab', 'VB-111', 'Unprimed Combination (upfront combination of VB-111 and bevacizumab', 'Sub-Therapeutic (VB-111 dose escalation), Limited Exposure (LE, VB-111 monotherapy until progression), Primed Combination ', 'VB-111 with and without bevacizumab']","['median PFS time', 'safety, tolerability and efficacy', 'Median OS time', 'median overall survival (OS', 'safety, overall response rate, and progression-free survival (PFS', 'tolerated', 'survival and PFS advantage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0889918,"Median OS time was significantly longer in the Primed Combination group compared to both LE (414 vs 223 days; HR 0.48; p=0.043), and Unprimed Combination (414 vs. 141.5 days; HR 0.24; p=0.0056); Patients in the combination phase of the Primed Combination group had a median PFS time of 90 days compared to 60 in the LE group (HR 0.36; p=0.032), and 63 in the Unprimed Combination group (p=0.72).","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Brenner', 'Affiliation': 'University of Texas Health San Antonio Mays Cancer Center, San Antonio, Texas, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Peters', 'Affiliation': 'Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Vredenburgh', 'Affiliation': 'Saint Francis Hospital and Medical Center, Hartford, Connecticut, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bokstein', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Deborah T', 'Initials': 'DT', 'LastName': 'Blumenthal', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Yust-Katz', 'Affiliation': 'Neuro-Oncology Unit, Davidoff Cancer Center at Rabin Medical Center, Petach Tikvah, Israel and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Idit', 'Initials': 'I', 'LastName': 'Peretz', 'Affiliation': 'Neuro-Oncology Unit, Davidoff Cancer Center at Rabin Medical Center, Petach Tikvah, Israel and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Bernice', 'Initials': 'B', 'LastName': 'Oberman', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Freedman', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Ellingson', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, Department of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'Department of Neurology, Ronald Reagan UCLA Medical Center, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Naamit', 'Initials': 'N', 'LastName': 'Sher', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Lowenton-Spier', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Rachmilewitz Minei', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Niva', 'Initials': 'N', 'LastName': 'Yakov', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Itzhak', 'Initials': 'I', 'LastName': 'Mendel', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Breitbart', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': 'Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}]",Neuro-oncology,['10.1093/neuonc/noz231']
1183,31844890,A randomized controlled phase III study of VB-111 combined with bevacizumab vs bevacizumab monotherapy in patients with recurrent glioblastoma (GLOBE).,"BACKGROUND


Ofranergene obadenovec (VB-111) is an anticancer viral therapy that demonstrated in a phase II study a survival benefit for patients with recurrent glioblastoma (rGBM) who were primed with VB-111 monotherapy that was continued after progression with concomitant bevacizumab.
METHODS


This pivotal phase III randomized, controlled trial compared the efficacy and safety of upfront combination of VB-111 and bevacizumab versus bevacizumab monotherapy. Patients were randomized 1:1 to receive VB-111 1013 viral particles every 8 weeks in combination with bevacizumab 10 mg/kg every 2 weeks (combination arm) or bevacizumab monotherapy (control arm). The primary endpoint was overall survival (OS), and secondary endpoints were objective response rate (ORR) by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS).
RESULTS


Enrolled were 256 patients at 57 sites. Median exposure to VB-111 was 4 months. The study did not meet its primary or secondary goals. Median OS was 6.8 versus 7.9 months in the combination versus control arm (hazard ratio, 1.20; 95% CI: 0.91-1.59; P = 0.19) and ORR was 27.3% versus 21.9% (P = 0.26). A higher rate of grades 3-5 adverse events was reported in the combination arm (67% vs 40%), mainly attributed to a higher rate of CNS and flu-like/fever events. Trends for improved survival with combination treatment were seen in the subgroup of patients with smaller tumors and in patients who had a posttreatment febrile reaction.
CONCLUSIONS


In this study, upfront concomitant administration of VB-111 and bevacizumab failed to improve outcomes in rGBM. Change of treatment regimen, with the lack of VB-111 monotherapy priming, may explain the differences from the favorable phase II results.
CLINICAL TRIALS REGISTRATION


NCT02511405.",2020,A higher rate of grade 3-5 Adverse Events was reported in the combination arm (67% vs 40%) mainly attributed to a higher rate of CNS and flu-like/fever events.,"['patients with recurrent glioblastoma (rGBM', 'patients with recurrent glioblastoma (GLOBE', '256 patients were enrolled at 57 sites']","['bevacizumab', 'VB-111 and bevacizumab versus bevacizumab monotherapy', 'VB-111 1013 viral particles q8W in combination with bevacizumab 10mg/Kg q2W (combination arm) or bevacizumab monotherapy (control arm', 'VB-111 and bevacizumab', 'VB-111 combined with bevacizumab vs. bevacizumab monotherapy']","['survival', 'rate of CNS and flu-like/fever events', 'overall survival (OS', 'objective response rate (ORR) by RANO and Progression Free Survival (PFS', 'efficacy and safety', 'ORR', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",256.0,0.111146,A higher rate of grade 3-5 Adverse Events was reported in the combination arm (67% vs 40%) mainly attributed to a higher rate of CNS and flu-like/fever events.,"[{'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Cloughesy', 'Affiliation': 'Department of Neurology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brenner', 'Affiliation': 'University of Texas Health San Antonio Cancer Center, San Antonio, Texas, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'de Groot', 'Affiliation': 'Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Butowski', 'Affiliation': 'Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Leor', 'Initials': 'L', 'LastName': 'Zach', 'Affiliation': 'Oncology Institute, Chaim Sheba Medical Center, Tel HaShomer, Israel.'}, {'ForeName': 'Jian L', 'Initials': 'JL', 'LastName': 'Campian', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Ellingson', 'Affiliation': 'UCLA Brain Tumor Imaging Laboratory, Center for Computer Vision and Imaging Biomarkers, Department of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Laurence S', 'Initials': 'LS', 'LastName': 'Freedman', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Chaim Sheba Medical Center, Tel HaShomer, Israel.'}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Lowenton-Spier', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Rachmilewitz Minei', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': 'Shifra', 'Initials': 'S', 'LastName': 'Fain Shmueli', 'Affiliation': ""VBL Therapeutics, Modi'in, Israel.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Patrick Y', 'Affiliation': 'Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}]",Neuro-oncology,['10.1093/neuonc/noz232']
1184,31845191,Micronutrients in support to the one carbon cycle for the modulation of blood fasting homocysteine in PCOS women.,"PURPOSE


Fasting blood homocysteine is increased in PCOS women and is involved in several of its co-morbidities including cardiovascular disease and infertility. Corrective interventions based on the administration of supra-physiologic doses of folic acid work to a low extent. We aimed to test an alternative approach.
METHODS


This was a prospective, randomized, parallel group, open label, controlled versus no treatment clinical study. PCOS women aged > 18, free from systemic diseases and from pharmacological treatments were randomized with a 2:1 ratio for treatment with activated micronutrients in support to the carbon cycle (Impryl, Parthenogen, Switzerland-n = 22) or no treatment (n = 10) and followed-up for 3 months. Fasting blood homocysteine, AMH, testosterone, SHBGs, and the resulting FTI were tested before and at the end of the follow-up.
RESULTS


The mean baseline fasting blood homocysteine was above the normal limit of 12 μMol/L and inversely correlated with SHBG. AMH was also increased, whereas testosterone, SHBG, and FTI were within the normal limit. The treatment achieved a significant reduction of homocysteine, that did not change in the control group, independently of the starting value. The treatment also caused an increase of AMH and a decrease of SHBGs only in the subgroup with a normal homocysteine at baseline.
CONCLUSIONS


In PCOS ladies, blood homocysteine is increased and inversely correlated with the SHBGs. Physiologic amounts of activated micronutrients in support to the carbon cycle achieve a reduction virtually in all exposed patients. Whether this is of clinical benefit remains to be established.",2020,"The treatment achieved a significant reduction of homocysteine, that did not change in the control group, independently of the starting value.","['PCOS women aged\u2009>\u200918, free from systemic diseases and from pharmacological treatments', 'PCOS women']","['activated micronutrients in support to the carbon cycle (Impryl, Parthenogen, Switzerland-n\u2009=\u200922) or no treatment']","['Fasting blood homocysteine, AMH, testosterone, SHBGs, and the resulting FTI', 'AMH', 'homocysteine', 'SHBGs', 'testosterone, SHBG, and FTI', 'blood homocysteine', 'mean baseline fasting blood homocysteine', 'blood fasting homocysteine']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0442893', 'cui_str': 'Systemic illness (qualifier value)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2936196', 'cui_str': 'Carbon Flux'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1328359', 'cui_str': 'Blood homocysteine'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0202024', 'cui_str': 'Free thyroxine index (procedure)'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0312446', 'cui_str': 'Somatotropin binding globulin (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005768'}]",,0.0418212,"The treatment achieved a significant reduction of homocysteine, that did not change in the control group, independently of the starting value.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Schiuma', 'Affiliation': 'Centro Demetra ARTeBIOS, Via Giardini 11, Lugo, RA, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Costantino', 'Affiliation': 'Centro Demetra ARTeBIOS, Via Giardini 11, Lugo, RA, Italy.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bartolotti', 'Affiliation': 'Centro Demetra ARTeBIOS, Via Giardini 11, Lugo, RA, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dattilo', 'Affiliation': 'Parthenogen, Piazza Indipendenza 11, Lugano, Switzerland. maurizio.dattilo@parthenogen.ch.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bini', 'Affiliation': 'Section of Internal Medicine and Endocrine and Metabolic Sciences, Department of Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Aglietti', 'Affiliation': 'Section of Internal Medicine and Endocrine and Metabolic Sciences, Department of Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Renga', 'Affiliation': 'Section of Internal Medicine and Endocrine and Metabolic Sciences, Department of Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Favilli', 'Affiliation': 'Section of Obstetrics and Gynecology, Department of Surgical and Biomedical Sciences, S. Maria della Misericordia Hospital, University of Perugia, Perugia, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falorni', 'Affiliation': 'Section of Internal Medicine and Endocrine and Metabolic Sciences, Department of Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gerli', 'Affiliation': 'Section of Obstetrics and Gynecology, Department of Surgical and Biomedical Sciences, S. Maria della Misericordia Hospital, University of Perugia, Perugia, Italy.'}]",Journal of endocrinological investigation,['10.1007/s40618-019-01163-x']
1185,31844133,Effect of diaphragm and abdominal muscle training on pelvic floor strength and endurance: results of a prospective randomized trial.,"Pelvic floor muscles (PFMs) play a crucial role in urinary continence. Therefore, training the PFMs remains the most popular conservative treatment for urinary incontinence (UI). The effect of training other body muscles on the PFMs is unclear and mostly hypothetical. The objective of our study was to evaluate the effectiveness of postoperative diaphragm muscle, abdominal muscle and PFM training on PFM strength (PFMS) and endurance (PFME) as well as on UI in men after radical prostatectomy (RP). Per-protocol PFMS, PFME and urine loss measurements were performed at 1, 3, and 6 months postoperatively. The primary endpoints were PFMS and PFME differences among the study groups. The secondary endpoint was the correlation between UI and PFMS and PFME. In total, 148 men were randomized to the treatment groups. An increase in PFMS and PFME was observed in all groups compared to baseline (p < 0.001). The greatest difference in PFMS was in the PFM training group, but diaphragm training had the best effect on PFME. The highest (from moderate to strong) correlation between UI and PFME and PFMS (r = -0.61 and r = -0.89, respectively) was observed in the diaphragm training group. Despite different but significant effects on PFMS and PFME, all rehabilitation-training programmes decreased UI in men after RP.",2019,"Despite different but significant effects on PFMS and PFME, all rehabilitation-training programmes decreased UI in men after RP.","['men after radical prostatectomy (RP', '148 men']","['diaphragm training', 'postoperative diaphragm muscle, abdominal muscle and PFM training', 'diaphragm and abdominal muscle training']","['PFMS and PFME differences', 'correlation between UI and PFMS and PFME', 'PFMS and PFME', 'pelvic floor strength and endurance', 'PFMS', 'UI and PFME and PFMS', 'PFM strength (PFMS) and endurance (PFME']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0000739', 'cui_str': 'Abdominal Muscles'}]","[{'cui': 'C0633055', 'cui_str': 'PFME'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]",148.0,0.015208,"Despite different but significant effects on PFMS and PFME, all rehabilitation-training programmes decreased UI in men after RP.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zachovajeviene', 'Affiliation': 'Lithuanian University of Health Sciences, Medical Academy, Clinic of Sport Medicine, Kaunas, Lithuania.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Siupsinskas', 'Affiliation': 'Lithuanian University of Health Sciences, Medical Academy, Clinic of Sport Medicine, Kaunas, Lithuania.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zachovajevas', 'Affiliation': 'Lithuanian Sport University, Department of Health Promotion and Rehabilitation, Kaunas, Lithuania.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Venclovas', 'Affiliation': 'Lithuanian University of Health Sciences, Medical Academy, Department of Urology, Kaunas, Lithuania.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Milonas', 'Affiliation': 'Lithuanian University of Health Sciences, Medical Academy, Department of Urology, Kaunas, Lithuania. Daimantas.Milonas@kaunoklinikos.lt.'}]",Scientific reports,['10.1038/s41598-019-55724-4']
1186,31844146,Effects of a comprehensive intervention on hypertension control in Chinese employees working in universities based on mixed models.,"We conducted a comprehensive intensive intervention for hypertension patients working in universities or colleges. From July 2015 to March in 2016, 220 hypertension subjects were recruited, with 165 cases in intensive intervention group and 55 in standard intervention group. After 24 months of intervention, 208 ones including of 157 in intensive intervention group and 51 in standard intervention group were included in the final analysis. The patients in standard intervention group were given routine intervention, which mainly including of drug treatment and health education. The patients in intervention group were given comprehensive intensive intervention in addition to routine intervention, including follow-up management of hypertension, emotional, lifestyle intervention and else. The study and experimental protocols were approved by institutional review board of Zhejiang Hospital and Fu Wai Hospital and registered (ChiCTR-ECS-14004641, date of registration: May 8, 2014). After 2 years, compared with the standard intervention group, SBP/DBP in the intensive intervention group decreased by 3.7/4 mmHg and BP control rate increased by 8.9%, and the unhealthy behaviors and life quality including tension and pressure were also improved in the intensive intervention group. We used mixed effect model to analyze the intervention effect which could solve the problems of missing values and correlation. The intensive intervention of hypertension control including follow-up management, emotional and lifestyle intervention in occupational places could promote the development of the prevention, treatment and control of hypertension among staff in colleges and universities.",2019,"After 2 years, compared with the standard intervention group, SBP/DBP in the intensive intervention group decreased by 3.7/4 ","['From July 2015 to March in 2016, 220 hypertension subjects were recruited, with 165 cases in intensive intervention group and 55 in standard intervention group', 'hypertension patients working in universities or colleges', 'Chinese employees working in universities based on mixed models']","['comprehensive intensive intervention', 'intensive intervention of hypertension control including follow-up management, emotional and lifestyle intervention', 'comprehensive intervention', 'comprehensive intensive intervention in addition to routine intervention, including follow-up management of hypertension, emotional, lifestyle intervention and else', 'routine intervention, which mainly including of drug treatment and health education']","['mmHg and BP control rate', 'hypertension control', 'SBP/DBP', 'unhealthy behaviors and life quality including tension and pressure']","[{'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018701'}]","[{'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0034380'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",220.0,0.0260555,"After 2 years, compared with the standard intervention group, SBP/DBP in the intensive intervention group decreased by 3.7/4 ","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Zhejiang Provincial Center for Cardiovascular Disease Control and Prevention, Zhejiang Hospital, Hangzhou, 310013, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Xiaoqing', 'Affiliation': 'Chinese Acupuncture Department, Zhejiang Hospital, Hangzhou, 310013, China.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Xinhua', 'Affiliation': 'Zhejiang Provincial Center for Cardiovascular Disease Control and Prevention, Zhejiang Hospital, Hangzhou, 310013, China.'}, {'ForeName': 'Shou', 'Initials': 'S', 'LastName': 'Xiaoling', 'Affiliation': 'Zhejiang Provincial Center for Cardiovascular Disease Control and Prevention, Zhejiang Hospital, Hangzhou, 310013, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Xiaoling', 'Affiliation': 'Zhejiang Provincial Center for Cardiovascular Disease Control and Prevention, Zhejiang Hospital, Hangzhou, 310013, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Zhejiang Provincial Center for Cardiovascular Disease Control and Prevention, Zhejiang Hospital, Hangzhou, 310013, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Zengwu', 'Affiliation': 'Department of Community Prevention and Control, National Cardiovascular Disease Center, Fuwai Hospital, BeiJing, 102308, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Xin', 'Affiliation': 'Department of Community Prevention and Control, National Cardiovascular Disease Center, Fuwai Hospital, BeiJing, 102308, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Pinpin', 'Affiliation': 'Key Laboratory of Public Health Safety, Ministry of Education, Health Communication Institute, Fudan University, 138 Yixueyuan Road, Shanghai, 200032, China. zpinpin@shmu.edu.cn.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jing', 'Affiliation': 'Zhejiang Provincial Center for Cardiovascular Disease Control and Prevention, Zhejiang Hospital, Hangzhou, 310013, China. phoebe84331@163.com.'}]",Scientific reports,['10.1038/s41598-019-55849-6']
1187,31819122,Population-based volume kinetics of crystalloids and colloids in healthy volunteers.,"We characterized the volume kinetics of crystalloid solutions (Ringer's lactate solution and 5% dextrose water) and colloid solutions (6% tetrastarch and 10% pentastarch) by nonlinear mixed-effects modeling in healthy volunteers. We also assessed whether the bioelectrical impedance analysis parameters are significant covariates for volume kinetic parameters. Twelve male volunteers were randomly allocated to four groups, and each group received the four fluid solutions in specified sequences, separated by 1-week intervals to avoid any carryover effects. Volunteers received 40 ml/kg Ringer's lactate solution, 20 ml/kg 5% dextrose water, 1000 ml 6% tetrastarch, and 1000 ml 10% pentastarch over 1 h. Arterial blood samples were collected to measure the hemoglobin concentration at different time points. Bioelectrical impedance spectroscopy (BIS, INBODY S10, InBody CO., LTD, Seoul, Korea) was also carried out at preset time points. In total, 671 hemoglobin-derived plasma dilution data points were used to determine the volume kinetic characteristics of each fluid. The changes in plasma dilution induced by administration of crystalloid and colloid solutions were well-described by the two-volume and one-volume models, respectively. Extracellular water was a significant covariate for the peripheral volume of distribution at baseline in the volume kinetic model of Ringer's lactate solution. When the same amount was administered, the colloid solutions had ~4 times more plasma expansion effect than did the crystalloid solutions. Starches with larger molecular weights maintained the volume expansion effect longer than those with smaller molecular weights.",2019,"When the same amount was administered, the colloid solutions had ~4 times more plasma expansion effect than did the crystalloid solutions.","['Twelve male volunteers', 'healthy volunteers']","[""40\u2009ml/kg Ringer's lactate solution, 20\u2009ml/kg 5% dextrose water, 1000\u2009ml 6% tetrastarch"", ""crystalloid solutions (Ringer's lactate solution and 5% dextrose water) and colloid solutions (6% tetrastarch and 10% pentastarch""]","['plasma expansion effect', 'Bioelectrical impedance spectroscopy (BIS, INBODY S10, InBody CO., LTD, Seoul, Korea', 'plasma dilution', 'hemoglobin concentration']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C1816356', 'cui_str': 'Product containing tetrastarch'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C2350383', 'cui_str': 'Pentastarch'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C2713504', 'cui_str': 'Spectroscopy'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0079240', 'cui_str': 'Dilution Technics'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}]",12.0,0.0609498,"When the same amount was administered, the colloid solutions had ~4 times more plasma expansion effect than did the crystalloid solutions.","[{'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Yi', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Korea.""}, {'ForeName': 'Ji-Yeon', 'Initials': 'JY', 'LastName': 'Bang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Bohyun', 'Initials': 'B', 'LastName': 'Choi', 'Affiliation': 'Department of Nursing, Graduate School and College of Nursing Science, KyungHee University, Seoul, Korea.'}, {'ForeName': 'Changhun', 'Initials': 'C', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yong-Hun', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun-Kyung', 'Initials': 'EK', 'LastName': 'Lee', 'Affiliation': 'Department of Statistics, Ewha Womans University, Seoul, Korea.'}, {'ForeName': 'Byung-Moon', 'Initials': 'BM', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. byungmoonchoi7@gmail.com.'}, {'ForeName': 'Gyu-Jeong', 'Initials': 'GJ', 'LastName': 'Noh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine and Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}]",Scientific reports,['10.1038/s41598-019-55171-1']
1188,31839626,An Incremental Sit-to-Stand Exercise for Evaluating Physical Capacity in Older Patients with Type 2 Diabetes.,"Exercise is recommended for older patients with type 2 diabetes mellitus (T2DM), and increased physical activity contributes to better management of their condition. The conventional exercise test with treadmill or cycle ergometer (CE) for assessing physical capacity, such as peak oxygen uptake (VO 2 ) and anaerobic threshold (AT), is not always usable for older patients with T2DM. The incremental sit-to-stand (ISTS) exercise is an incremental exercise test using external signals to control the sit-to-stand rate in a given time frame and can be performed in a small space using only a chair. This study aimed to examine the validity of the physical capacity assessment during the ISTS exercise, based on the relationships between the ISTS performance, peak VO 2 , AT on ISTS exercise and CE test, in older patients with T2DM. Twenty-two patients with T2DM (10 men, 12 women; mean age, 68.0 years; range, 61-77 years) performed ISTS exercise (according to an existing protocol) and CE test in a randomized manner. Peak VO 2 , AT, and completion time were determined for the ISTS exercise and CE test. Peak VO 2  during ISTS exercise was significantly associated with that during the CE test (r = 0.89, p < 0.01). The completion time on the ISTS exercise was significantly associated with peak VO 2  (r = 0.80, p < 0.01) and AT on the ISTS exercise (r = 0.78, p < 0.01). The ISTS exercise is a useful tool to determine the physical capacity and estimate peak VO 2  and AT in older people with T2DM.",2019,The ISTS exercise is a useful tool to determine the physical capacity and estimate peak VO 2  and AT in older people with T2DM.,"['Older Patients with Type 2 Diabetes', 'older patients with T2DM', 'older people with T2DM', 'Twenty-two patients with T2DM (10 men, 12 women; mean age, 68.0 years; range, 61-77 years) performed', 'older patients with type 2 diabetes mellitus (T2DM']","['Exercise', 'incremental sit-to-stand (ISTS) exercise', 'Incremental Sit-to-Stand Exercise', 'ISTS exercise', 'conventional exercise test with treadmill or cycle ergometer (CE']","['completion time on the ISTS exercise', 'Peak VO 2  during ISTS exercise', 'peak oxygen uptake (VO 2 ) and anaerobic threshold (AT', 'Peak VO 2 , AT, and completion time']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}]",,0.0211177,The ISTS exercise is a useful tool to determine the physical capacity and estimate peak VO 2  and AT in older people with T2DM.,"[{'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Rehabilitation, Matsumoto City Hospital.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Nagasawa', 'Affiliation': 'Department of Rehabilitation, Matsumoto City Hospital.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Sawaki', 'Affiliation': 'Department of Internal Medicine, Matsumoto City Hospital.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Yokokawa', 'Affiliation': 'Department of Physical Therapy, Shinshu University.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Ohira', 'Affiliation': 'Department of Rehabilitation, Kanno Dialysis and Vascular Access Clinic.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Internal Medicine, Matsumoto City Hospital.'}]",The Tohoku journal of experimental medicine,['10.1620/tjem.249.241']
1189,31684055,A Psychosocial Intervention's Impact on Quality of Life in AYAs with Cancer: A Post Hoc Analysis from the Promoting Resilience in Stress Management (PRISM) Randomized Controlled Trial.,"Promoting Resilience in Stress Management (PRISM), a psychosocial intervention for adolescents and young adults (AYAs) with serious illness, enhances resilience resources via four skills-based training sessions. A recent randomized controlled trial showed PRISM improved health-related quality of life (HRQOL) compared to usual care (UC). This post hoc exploratory analysis aimed to better understand the effect of PRISM on HRQOL by describing changes in HRQOL subdomain scores. English-speaking AYAs (12-25 years) with cancer were randomized to PRISM or UC. At enrollment and six months later, HRQOL was assessed using the Pediatric Quality of Life Inventory (PedsQL) Generic Short Form (SF-15) and Cancer Module. Scores at each time point were summarized descriptively and individual HRQOL trajectories were categorized (<70 vs. ≥70). ""Positive"" trajectories indicate participants maintained scores ≥70 or improved from <70 to ≥70 during the study period. Baseline assessments were completed by 92 participants (48 PRISM, 44 UC); six-month assessments were completed by 74 participants (36 PRISM, 38 UC). For the SF-15, positive trajectories in psychosocial domains were more common with PRISM; trajectories in the physical subdomain were similar across groups. For the Cancer Module, positive trajectories were more common with PRISM in the following subdomains: nausea, treatment anxiety, worry, cognitive, physical appearance, and communication. From this, we conclude PRISM may improve HRQOL, especially in psychosocial domains of wellbeing.",2019,"For the Cancer Module, positive trajectories were more common with PRISM in the following subdomains: nausea, treatment anxiety, worry, cognitive, physical appearance, and communication.","['English-speaking AYAs (12-25 years) with cancer', 'in AYAs with Cancer', 'adolescents and young adults (AYAs) with serious illness']","['Generic Short Form (SF-15) and Cancer Module', 'PRISM or UC']","['Pediatric Quality of Life Inventory (PedsQL', 'nausea, treatment anxiety, worry, cognitive, physical appearance, and communication', 'Quality of Life', 'health-related quality of life (HRQOL', 'HRQOL subdomain scores', 'Stress Management (PRISM']","[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0034380'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0750731', 'cui_str': 'Physical Appearance, Body'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}]",92.0,0.214109,"For the Cancer Module, positive trajectories were more common with PRISM in the following subdomains: nausea, treatment anxiety, worry, cognitive, physical appearance, and communication.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Steineck', 'Affiliation': ""Center for Cancer and Blood Disorders Center, Seattle Children's Hospital, Seattle, WA 98105, USA. angela.steineck@seattlechildrens.org.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Bradford', 'Affiliation': ""Children's Core for Biomedical Statistics, Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, WA 98105, USA. miranda.bradford@seattlechildrens.org.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lau', 'Affiliation': 'Department of Pediatrics, University of Washington School of Medicine, Seattle, WA 98105, USA. nancy.lau@seattlechildrens.org.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': ""Center for Cancer and Blood Disorders Center, Seattle Children's Hospital, Seattle, WA 98105, USA. samantha.scott@seattlechildrens.org.""}, {'ForeName': 'Joyce P', 'Initials': 'JP', 'LastName': 'Yi-Frazier', 'Affiliation': ""Center for Cancer and Blood Disorders Center, Seattle Children's Hospital, Seattle, WA 98105, USA. joyce.yi-frazier@seattlechildrens.org.""}, {'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Rosenberg', 'Affiliation': ""Center for Cancer and Blood Disorders Center, Seattle Children's Hospital, Seattle, WA 98105, USA. Abby.Rosenberg@seattlechildrens.org.""}]","Children (Basel, Switzerland)",['10.3390/children6110124']
1190,31373658,Process evaluation of a community-based diabetes prevention program in China: the Pathway to Health (PATH).,"High prevalence of diabetes and prediabetes has emerged as a concern in China. The Pathway to Health Program was designed to prevent type 2 diabetes onset in prediabetic women in a north China urban community. This process evaluation of a randomized controlled trial analysed participant surveys at the 6- and 12-month assessment times, participant weekly logs, class attendance records and post-study participant focus group results. The reported levels of participant engagement in physical activity (PA)-related behaviors were higher than diet-related behaviors at the 6-month assessment. The engagement in both PA- and diet-related behaviors declined during the 6-month follow-up period. Step counts from the participants' pedometers indicated an increase in PA in the first 6 months of the intervention. Study participants expressed high levels of satisfaction with the intervention and increased their scores on diabetes-related knowledge. Conflicts with work and family responsibilities were the main barriers for missing health lessons, likely contributing to minimal weight loss. There was good fidelity in program implementation. Intensive lifestyle modification programs are difficult to sustain once the program is complete. A more structured 6-month follow-up phase may have provided needed support to enable participants to maintain their lifestyle changes.",2019,Study participants expressed high levels of satisfaction with the intervention and increased their scores on diabetes-related knowledge.,"['prediabetic women in a north China urban community', 'China']",['community-based diabetes prevention program'],"['PA', 'physical activity (PA)-related behaviors']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0148955,Study participants expressed high levels of satisfaction with the intervention and increased their scores on diabetes-related knowledge.,"[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Strand', 'Affiliation': 'North Dakota State University, Fargo, ND, USA.'}, {'ForeName': 'Meizi', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'University of Texas at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Johnson', 'Affiliation': ""H'Image Doctor, Shenyang, Liaoning, China.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Perry', 'Affiliation': 'Medical Department, Shanxi Evergreen Service, Taiyuan, China.'}, {'ForeName': 'Zenong', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'University of Texas at San Antonio, San Antonio, TX, USA.'}]",Health education research,['10.1093/her/cyz023']
1191,31333058,Quantitative Assessment of Effectiveness of Ultrasonic Propulsion of Kidney Stones.,"Purpose:  Ultrasonic propulsion is an investigative modality to noninvasively image and reposition urinary stones. Our goals were to test safety and effectiveness of new acoustic exposure conditions from a new transducer, and to use simultaneous ureteroscopic and ultrasonic observation to quantify stone repositioning.  Materials and Methods:  During operation, ultrasonic propulsion was applied transcutaneously, whereas stone targets were visualized ureteroscopically. Exposures were 350 kHz frequency, ≤200 W/cm 2  focal intensity, and ≤3-second bursts per push. Ureteroscope and ultrasound (US) videos were recorded. Video clips with and without stone motion were randomized and scored for motion ≥3 mm by independent reviewers blinded to the exposures. Subjects were followed with telephone calls, imaging, and chart review for adverse events.  Results:  The investigative treatment was used in 18 subjects and 19 kidneys. A total of 62 stone targets were treated ranging in size from a collection of ""dust"" to 15 mm. Subjects received an average of 17 ± 14 propulsion bursts (per kidney) for a total average exposure time of 40 ± 40 seconds. Independent reviewers scored at least one stone movement ≥3 mm in 18 of 19 kidneys (95%) from the ureteroscope videos and in 15 of 19 kidneys (79%) from the US videos. This difference was probably because of motion out of the US imaging plane. Treatment repositioned stones in two cases that would have otherwise required basket repositioning. No serious adverse events were observed with the device or procedure.  Conclusions:  Ultrasonic propulsion was shown to be safe, and it effectively repositioned stones in 95% of kidneys despite positioning and access restrictions caused by working in an operating room on anesthetized subjects.",2019,"CONCLUSIONS


Ultrasonic propulsion was shown to be safe, and it effectively repositioned stones in 95% of kidneys despite positioning and access restrictions caused by working in an operating room on anesthetized subjects.",['18 subjects and 19 kidneys'],"['ultrasonic propulsion of kidney stones', 'Ultrasonic propulsion', 'Video clips with and without stone motion']","['Ureteroscope and ultrasound (US) videos', 'serious adverse events']","[{'cui': 'C0022646', 'cui_str': 'Kidney'}]","[{'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}]","[{'cui': 'C0184213', 'cui_str': 'Ureteroscopes'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",62.0,0.0458556,"CONCLUSIONS


Ultrasonic propulsion was shown to be safe, and it effectively repositioned stones in 95% of kidneys despite positioning and access restrictions caused by working in an operating room on anesthetized subjects.","[{'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Dai', 'Affiliation': 'Department of Urology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Mathew D', 'Initials': 'MD', 'LastName': 'Sorensen', 'Affiliation': 'Department of Urology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'Chang', 'Affiliation': 'Department of Urology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Samson', 'Affiliation': 'Department of Urology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Barbrina', 'Initials': 'B', 'LastName': 'Dunmire', 'Affiliation': 'Center for Industrial and Medical Ultrasound, Applied physics Laboratory, University of Washington, Seattle, Washington.'}, {'ForeName': 'Bryan W', 'Initials': 'BW', 'LastName': 'Cunitz', 'Affiliation': 'Center for Industrial and Medical Ultrasound, Applied physics Laboratory, University of Washington, Seattle, Washington.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Thiel', 'Affiliation': 'Center for Industrial and Medical Ultrasound, Applied physics Laboratory, University of Washington, Seattle, Washington.'}, {'ForeName': 'Ziyue', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Bailey', 'Affiliation': 'Department of Urology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Harper', 'Affiliation': 'Department of Urology, University of Washington, Seattle, Washington.'}]",Journal of endourology,['10.1089/end.2019.0340']
1192,31268466,Temporal Changes in Coronary Hyperemic and Resting Hemodynamic Indices in Nonculprit Vessels of Patients With ST-Segment Elevation Myocardial Infarction.,"Importance


Percutaneous coronary intervention (PCI) of nonculprit vessels among patients with ST-segment elevation myocardial infarction (STEMI) is associated with improved clinical outcome compared with culprit vessel-only PCI. Fractional flow reserve (FFR) and coronary flow reserve are hyperemic indices used to guide revascularization. Recently, instantaneous wave-free ratio was introduced as a nonhyperemic alternative to FFR. Whether these indices can be used in the acute setting of STEMI continues to be investigated.
Objective


To assess the value of hemodynamic indices in nonculprit vessels of patients with STEMI from the index event to 1-month follow-up.
Design, Setting, and Participants


This substudy of the Reducing Micro Vascular Dysfunction in Revascularized STEMI Patients by Off-target Properties of Ticagrelor (REDUCE-MVI) randomized clinical trial enrolled 98 patients with STEMI who had an angiographic intermediate stenosis in at least 1 nonculprit vessel. Patient enrollment was between May 1, 2015, and September 19, 2017. After successful primary PCI, nonculprit intracoronary hemodynamic measurements were performed and repeated at 1-month follow-up. Cardiac magnetic resonance imaging was performed from 2 to 7 days and 1 month after primary PCI.
Main Outcomes and Measures


The value of nonculprit instantaneous wave-free ratio, FFR, coronary flow reserve, hyperemic index of microcirculatory resistance, and resting microcirculatory resistance from the index event to 1-month follow-up.
Results


Of 73 patients with STEMI included in the final analysis, 59 (80.8%) were male, with a mean (SD) age of 60.8 (9.9) years. Instantaneous wave-free ratio (SD) did not change significantly (0.93 [0.07] vs 0.94 [0.06]; P = .12) and there was no change in resting distal pressure/aortic pressure (mean [SD], 0.94 [0.06] vs 0.95 [0.06]; P = .25) from the acute moment to 1-month follow-up. The FFR decreased (mean [SD], 0.88 [0.07] vs 0.86 [0.09]; P = .001) whereas coronary flow reserve increased (mean [SD], 2.9 [1.4] vs 4.1 [2.2]; P < .001). Hyperemic index of microcirculatory resistance decreased and resting microcirculatory resistance increased from the acute moment to follow-up. The decrease in distal pressure from rest to hyperemia was smaller at the acute moment vs follow-up (mean [SD], 10.6 [11.2] mm Hg vs 14.1 [14.2] mm Hg; P = .05). This blunted acute hyperemic response correlated with final infarct size (ρ, -0.29; P = .02). The resistive reserve ratio was lower at the acute moment vs follow-up (mean [SD], 3.4 [1.7] vs 5.0 [2.7]; P < .001).
Conclusions and Relevance


In the acute setting of STEMI, nonculprit coronary flow reserve was reduced and FFR was augmented, whereas instantaneous wave-free ratio was not altered. These results may be explained by an increased hyperemic microvascular resistance and a blunted adenosine responsiveness at the acute moment that was associated with infarct size.",2019,Instantaneous wave-free ratio (SD) did not change significantly (0.93 [0.07] vs 0.94 [0.06];,"['73 patients with STEMI included in the final analysis, 59 (80.8%) were male, with a mean (SD) age of 60.8 (9.9) years', 'Patients With ST-Segment Elevation Myocardial Infarction', 'patients with ST-segment elevation myocardial infarction (STEMI', '98 patients with STEMI who had an angiographic intermediate stenosis in at least 1 nonculprit vessel', 'nonculprit vessels of patients with STEMI from the index event to 1-month follow-up']","['Percutaneous coronary intervention (PCI', 'Ticagrelor', 'Cardiac magnetic resonance imaging']","['resistive reserve ratio', 'Fractional flow reserve (FFR) and coronary flow reserve', 'Coronary Hyperemic and Resting Hemodynamic Indices', 'distal pressure', 'resting distal pressure/aortic pressure', 'blunted acute hyperemic response', 'coronary flow reserve', 'value of nonculprit instantaneous wave-free ratio, FFR, coronary flow reserve, hyperemic index of microcirculatory resistance, and resting microcirculatory resistance', 'Hyperemic index of microcirculatory resistance decreased and resting microcirculatory resistance', 'Instantaneous wave-free ratio (SD', 'FFR', 'hyperemic microvascular resistance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0456180', 'cui_str': 'Aortic Blood Pressure'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}]",98.0,0.0728239,Instantaneous wave-free ratio (SD) did not change significantly (0.93 [0.07] vs 0.94 [0.06];,"[{'ForeName': 'Nina W', 'Initials': 'NW', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Guus A', 'Initials': 'GA', 'LastName': 'de Waard', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Everaars', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Broyd', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, London, United Kingdom.'}, {'ForeName': 'Casper W H', 'Initials': 'CWH', 'LastName': 'Beijnink', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology, Hammersmith Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Petraco', 'Affiliation': 'Department of Cardiology, Hammersmith Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ten Cate', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Department of Cardiology, Hospital Clínico San Carlos El Instituto de Investigación Sanitaria del Hospital Clinic San Carlos and Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'Department of Cardiology, Hammersmith Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'Maarten A H', 'Initials': 'MAH', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2138']
1193,31302584,Fracture behaviour of MOD restorations reinforced by various fibre-reinforced techniques - An in vitro study.,"PURPOSE


The aim was to evaluate the fracture resistance of various direct restorative techniques utilizing different fibre-reinforced materials for restoring deep class II. MOD cavities in molar teeth.
MATERIAL AND METHODS


Two hundred forty intact mandibular third molars were randomly divided into twelve groups (n = 20). Except for the control group (G12), deep mesio-occluso-distal (MOD) cavities were prepared all other groups. After adhesive treatment and rebuilding the missing interproximal walls with composite, the specimen were restored with different fibres and a final occlusal layer of composite as follows: composite only (G1), short fibre-reinforced composite (SFRC) (G2), glass fibre net (GFN) on the base of the cavity bucco-lingually (BL) and SFRC (G3), SFRC and GFN on top of it BL (G4), SFRC and occlusal splinting with GFN (G5), GFN circumferentially and SFRC (G6), polyethylene fibres (PF) on the base of the cavity BL and composite (G7), composite and PF on top of it BL (G8), composite and occlusal splinting with PF (G9), PF circumferentially and composite (G10), transcoronal splinting with PF (G11). Fracture-resistance for the restored teeth were tested using universal-testing machine. Fracture thresholds and fracture patterns were measured and evaluated.
RESULTS


The transcoronal splinting (G11) yielded the highest fracture resistance among the restored groups. Groups 1, 3 and 4 showed significantly lower fracture resistance values compared to intact teeth.
CONCLUSION


Incorporating polyethylene or a combination of short and bidirectional glass fibres in certain positions in direct restorations seems to be able to restore the fracture resistance of sound molar teeth.",2019,"Groups 1, 3 and 4 showed significantly lower fracture resistance values compared to intact teeth.
",['Two hundred forty intact mandibular third molars'],"['short fibre-reinforced composite (SFRC) (G2), glass fibre net (GFN) on the base of the cavity bucco-lingually (BL) and SFRC (G3), SFRC and GFN on top of it BL (G4), SFRC and occlusal splinting with GFN (G5), GFN circumferentially and SFRC (G6), polyethylene fibres (PF) on the base of the cavity BL and composite (G7), composite and PF on top of it BL (G8), composite and occlusal splinting with PF (G9), PF circumferentially and composite (G10), transcoronal splinting with PF (G11']","['deep mesio-occluso-distal (MOD) cavities', 'Fracture-resistance', 'Fracture thresholds and fracture patterns', 'highest fracture resistance', 'fracture resistance values']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0137914', 'cui_str': 'Polythene'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",240.0,0.0227235,"Groups 1, 3 and 4 showed significantly lower fracture resistance values compared to intact teeth.
","[{'ForeName': 'Tekla', 'Initials': 'T', 'LastName': 'Sáry', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Sufyan', 'Initials': 'S', 'LastName': 'Garoushi', 'Affiliation': 'Department of Biomaterials Science and Turku Clinical Biomaterials Center -TCBC, Institute of Dentistry, University of Turku, Turku, Finland.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Braunitzer', 'Affiliation': 'DicomLAB Dental Ltd., Szeged, Hungary.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Alleman', 'Affiliation': 'The Alleman Center for Biomimetic Dentistry, Utah, USA.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Volom', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Márk', 'Initials': 'M', 'LastName': 'Fráter', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary. Electronic address: meddentist.fm@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.07.006']
1194,31332298,Exogenous testosterone increases sensitivity to moral norms in moral dilemma judgements.,"Moral dilemma judgements frequently involve decisions where moral norms and the greater good are in conflict. The current preregistered study tested the effect of the steroid hormone testosterone on moral dilemma judgements using a double-blind administration of testosterone or placebo. Counter to predictions, testosterone administration led to increased inaction in moral dilemmas where harmful actions prohibited by moral norms increase overall well-being. Using a mathematical model to disentangle sensitivity to consequences, sensitivity to moral norms and general preference for inaction versus action, analyses further revealed that testosterone administration influenced judgements by increasing sensitivity to moral norms. Exploratory analyses suggested the opposite pattern for endogenous testosterone measured at baseline, in that higher levels of endogenous testosterone were associated with lower sensitivity to moral norms. The results indicate that the role of testosterone in moral judgements is more complex than suggested by previous findings. PROTOCOL REGISTRATION: The stage 1 protocol for this Registered Report was accepted in principle on 13 November 2017. The protocol, as accepted by the journal, can be found at https://osf.io/rysbe/  1 .",2019,"Counter to predictions, testosterone administration led to increased inaction in moral dilemmas where harmful actions prohibited by moral norms increase overall well-being.",[],"['testosterone or placebo', 'Exogenous testosterone', 'steroid hormone testosterone']",['endogenous testosterone'],[],"[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone (substance)'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]",,0.121978,"Counter to predictions, testosterone administration led to increased inaction in moral dilemmas where harmful actions prohibited by moral norms increase overall well-being.","[{'ForeName': 'Skylar M', 'Initials': 'SM', 'LastName': 'Brannon', 'Affiliation': 'Department of Psychology, University of Texas at Austin, Austin, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Carr', 'Affiliation': 'Department of Psychology, University of Texas at Austin, Austin, USA.'}, {'ForeName': 'Ellie Shuo', 'Initials': 'ES', 'LastName': 'Jin', 'Affiliation': 'Department of Psychology, University of Texas at Austin, Austin, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Josephs', 'Affiliation': 'Department of Psychology, University of Texas at Austin, Austin, USA.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Gawronski', 'Affiliation': 'Department of Psychology, University of Texas at Austin, Austin, USA. gawronski@utexas.edu.'}]",Nature human behaviour,['10.1038/s41562-019-0641-3']
1195,31326732,Modulation of brain activity with transcranial direct current stimulation: Targeting regions implicated in impaired illness awareness in schizophrenia.,"BACKGROUND


Impaired illness awareness or insight into illness (IIA) is a common feature of schizophrenia that contributes to medication nonadherence and poor clinical outcomes. Neuroimaging studies suggest IIA may arise from interhemispheric imbalance in frontoparietal regions, particularly in the posterior parietal area (PPA) and the dorsolateral prefrontal cortex (dlPFC). In this pilot study, we examined the effects of transcranial direct current stimulation (tDCS) on brain regions implicated in IIA.
METHODS


Eleven patients with schizophrenia with IIA (≥3 PANSS G12) and 10 healthy controls were included. A crossover design was employed where all participants received single-session bi-frontal, bi-parietal, and sham stimulation in random order. For each condition, we measured (i) blood oxygen level-dependent (BOLD) response to an illness awareness task pre- and post-stimulation, (ii) regional cerebral blood-flow (rCBF) prior to and during stimulation, and (iii) changes in illness awareness.
RESULTS


At baseline, patients with schizophrenia showed higher BOLD-response to an illness awareness task in the left-PPA compared to healthy controls. Bi-parietal stimulation reduced the interhemispheric imbalance in the PPA compared to sham stimulation. Relatedly, bi-parietal stimulation increased rCBF beneath the anode (21% increase in the right-PPA), but not beneath the cathode (5.6% increase in the left-PPA). Bi-frontal stimulation did not induce changes in rCBF. We found no changes in illness awareness.
CONCLUSION


Although single-session tDCS did not improve illness awareness, this pilot study provides mechanistic justification for future investigations to determine if multi-session bi-parietal tDCS can induce sustained changes in brain activity in the PPA in association with improved illness awareness.",2019,"At baseline, patients with schizophrenia showed higher BOLD-response to an illness awareness task in the left-PPA compared to healthy controls.","['schizophrenia', 'Eleven patients with schizophrenia with IIA (≥3 PANSS G12) and 10 healthy controls were included']","['transcranial direct current stimulation', 'transcranial direct current stimulation (tDCS']","['measured (i) blood oxygen level-dependent (BOLD) response to an illness awareness task pre- and post-stimulation, (ii) regional cerebral blood-flow (rCBF) prior to and during stimulation, and (iii) changes in illness awareness', 'BOLD-response', 'rCBF', 'interhemispheric imbalance']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0292784,"At baseline, patients with schizophrenia showed higher BOLD-response to an illness awareness task in the left-PPA compared to healthy controls.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Multimodal Imaging Group, Research Imaging Centre, Centre for Addiction and Mental Health, (CAMH), University of Toronto, Toronto, Ontario, Canada; Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Plitman', 'Affiliation': 'Cerebral Imaging Centre, Douglas Mental Health University Institute, McGill University, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Nakajima', 'Affiliation': 'Multimodal Imaging Group, Research Imaging Centre, Centre for Addiction and Mental Health, (CAMH), University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Geriatric Mental Health Division, CAMH, University of Toronto, Toronto, Ontario, Canada; Department of Neuropsychiatry, Keio University, Tokyo, Japan.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Alshehri', 'Affiliation': 'Geriatric Mental Health Division, CAMH, University of Toronto, Toronto, Ontario, Canada; Campbell Family Mental Health Research Institute, CAMH, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Iwata', 'Affiliation': 'Multimodal Imaging Group, Research Imaging Centre, Centre for Addiction and Mental Health, (CAMH), University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jun Ku', 'Initials': 'JK', 'LastName': 'Chung', 'Affiliation': 'Multimodal Imaging Group, Research Imaging Centre, Centre for Addiction and Mental Health, (CAMH), University of Toronto, Toronto, Ontario, Canada; Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Caravaggio', 'Affiliation': 'Multimodal Imaging Group, Research Imaging Centre, Centre for Addiction and Mental Health, (CAMH), University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Menon', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Geriatric Mental Health Division, CAMH, University of Toronto, Toronto, Ontario, Canada; Campbell Family Mental Health Research Institute, CAMH, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Pollock', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Geriatric Mental Health Division, CAMH, University of Toronto, Toronto, Ontario, Canada; Department of Neuropsychiatry, Keio University, Tokyo, Japan.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Remington', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Geriatric Mental Health Division, CAMH, University of Toronto, Toronto, Ontario, Canada; Campbell Family Mental Health Research Institute, CAMH, University of Toronto, Toronto, Ontario, Canada; Schizophrenia Division, CAMH, Toronto, Ontario, Canada.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'De Luca', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Geriatric Mental Health Division, CAMH, University of Toronto, Toronto, Ontario, Canada; Campbell Family Mental Health Research Institute, CAMH, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Graff-Guerrero', 'Affiliation': 'Multimodal Imaging Group, Research Imaging Centre, Centre for Addiction and Mental Health, (CAMH), University of Toronto, Toronto, Ontario, Canada; Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Geriatric Mental Health Division, CAMH, University of Toronto, Toronto, Ontario, Canada; Campbell Family Mental Health Research Institute, CAMH, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Gerretsen', 'Affiliation': 'Multimodal Imaging Group, Research Imaging Centre, Centre for Addiction and Mental Health, (CAMH), University of Toronto, Toronto, Ontario, Canada; Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Geriatric Mental Health Division, CAMH, University of Toronto, Toronto, Ontario, Canada; Campbell Family Mental Health Research Institute, CAMH, University of Toronto, Toronto, Ontario, Canada. Electronic address: philgerretsen@yahoo.com.'}]",European psychiatry : the journal of the Association of European Psychiatrists,['10.1016/j.eurpsy.2019.06.007']
1196,31006069,"Pedicle screw insertion with patient-specific 3D-printed guides based on low-dose CT scan is more accurate than free-hand technique in spine deformity patients: a prospective, randomized clinical trial.","BACKGROUND


Screw misplacement incidence can be as high as 15-30% in spine deformity surgery, with possible devastating consequences. Some technical solutions to prevent misplacement require expensive devices. MySpine TM  comprises a low-dose CT scan of the patient's spine to build a virtual model of the spine to plan the screw trajectories and a 3D-printed patient-specific guide system to prepare the screw trajectories and to implant the screws in the vertebrae in order to increase reproducibility and safety of the implants. The aim of this open-label, single-center, prospective randomized clinical trial with independent evaluation of outcomes was to compare the accuracy of free-hand insertion of pedicle screws to MySpine TM  3D-printed patient-specific guides.
METHODS


Twenty-nine patients undergoing surgical correction for spinal deformity were randomized to Group A (pedicle screws implantation with MySpine TM ) or Group B (free-hand implantation). Group A received 297 pedicle screws, and Group B 243 screws. Forty-three screws in Group A crossed over to free-hand implantation. Screw position was graded according to Gertzbein in grades 0, A, B or C, with grades 0 or A considered as ""safe area."" Total fluoroscopy dose and time were compared in six patients of each group.
RESULTS


Comparing the two study groups, we observed a statistically significant difference between the two groups (p < 0.05), with 96.1% of screws in the ""safe area"" in Group A versus a 82.9% in Group B. Group-A patients had a mean effective dose of 0.23 mSv compared to 0.82 mSv in Group B. Patient-specific, 3D-printed pedicle screw guides increase safety in a wide spectrum of deformity conditions. In addition, the total radiation dose is reduced, even considering the need of a low-dose preoperative CT for surgical planning.
LEVEL OF EVIDENCE


I. These slides can be retrieved under Electronic Supplementary Material.",2019,"Comparing the two study groups, we observed a statistically significant difference between the two groups (p < 0.05), with 96.1% of screws in the ""safe area"" in Group A versus a 82.9% in","['Twenty-nine patients undergoing surgical correction for spinal deformity', 'spine deformity patients']","['Group A (pedicle screws implantation with MySpine TM ) or Group B (free-hand implantation', 'Pedicle screw insertion with patient-specific 3D-printed guides based on low-dose CT scan', '297 pedicle screws', 'MySpine TM']",['Total fluoroscopy dose and time'],"[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0575157', 'cui_str': 'Deformity of spine (finding)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}]","[{'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1293259', 'cui_str': 'Hand implantation'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",29.0,0.0564761,"Comparing the two study groups, we observed a statistically significant difference between the two groups (p < 0.05), with 96.1% of screws in the ""safe area"" in Group A versus a 82.9% in","[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Cecchinato', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy. dott.cecchinato@gmail.com.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Berjano', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zerbi', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Damilano', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Redaelli', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Lamartina', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-05978-3']
1197,31084971,Intraoperative Ketamine in Total Knee Arthroplasty Does Not Decrease Pain and Narcotic Consumption: A Prospective Randomized Controlled Trial.,"BACKGROUND


Multiple studies have demonstrated that ketamine, a glutamate receptor blocker, may decrease postoperative pain in abdominal and orthopedic surgeries. However, its role with spinal anesthesia and total knee arthroplasty (TKA) remains unknown. The purpose of this study is to determine the efficacy of subanesthetic dosing of ketamine during TKA on postoperative pain and narcotic consumption.
METHODS


In this prospective, randomized, double-blinded clinical trial, we enrolled 91 patients undergoing primary TKA with spinal anesthesia in a single institution from 2017 to 2018. Patients were randomized to receive intraoperative ketamine infusion at a rate of 6 mcg/kg/min for 75 minutes or a saline placebo. All patients received spinal anesthesia and otherwise identical surgical approaches, pain management, and rehabilitation protocols. Patient-reported visual analog pain scores were calculated preoperatively, postoperative days (POD) 0-7, and 2 weeks. Narcotic consumption was evaluated on POD 0 and 1.
RESULTS


There was no difference in average pain between ketamine and placebo at all time points except for at PODs 1 (45 vs 56, P = .041) and 4 (39 vs 49, P = .040). For least pain experienced, patients administered with ketamine experienced a reduction in pain only at POD 4 (22 vs 35, P = .011). There was no difference in maximum pain cohorts at all time points of the study or in-hospital morphine equivalents between the 2 cohorts.
CONCLUSION


As part of multimodal pain management protocol, intraoperative ketamine does not result in a clinically significant improvement in pain and narcotic consumption following TKA.",2019,"There was no difference in average pain between ketamine and placebo at all time points except for at PODs 1 (45 vs 56, P = .041) and 4 (39 vs 49, P = .040).",['91 patients undergoing primary TKA with spinal anesthesia in a single institution from 2017 to 2018'],"['ketamine', 'placebo', 'saline placebo', 'TKA', 'spinal anesthesia and total knee arthroplasty (TKA', 'Intraoperative Ketamine', 'intraoperative ketamine infusion', 'spinal anesthesia and otherwise identical surgical approaches, pain management, and rehabilitation protocols']","['maximum pain', 'pain', 'postoperative pain and narcotic consumption', 'pain and narcotic consumption', 'average pain', 'visual analog pain scores', 'Pain and Narcotic Consumption', 'Narcotic consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0449446', 'cui_str': 'Surgical approach (attribute)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",91.0,0.45266,"There was no difference in average pain between ketamine and placebo at all time points except for at PODs 1 (45 vs 56, P = .041) and 4 (39 vs 49, P = .040).","[{'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Tan', 'Affiliation': 'Rothman Orthopaedic Institute, Department of Orthopaedic Surgery, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Longenecker', 'Affiliation': 'Rothman Orthopaedic Institute, Bryn Mawr Hospital, Bryn Mawr, PA.'}, {'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Rhee', 'Affiliation': 'Rothman Orthopaedic Institute, Bryn Mawr Hospital, Bryn Mawr, PA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Good', 'Affiliation': 'Rothman Orthopaedic Institute, Bryn Mawr Hospital, Bryn Mawr, PA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Emper', 'Affiliation': 'Rothman Orthopaedic Institute, Bryn Mawr Hospital, Bryn Mawr, PA.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Freedman', 'Affiliation': 'Rothman Orthopaedic Institute, Bryn Mawr Hospital, Bryn Mawr, PA.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Shaner', 'Affiliation': 'Rothman Orthopaedic Institute, Department of Orthopaedic Surgery, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'McComb', 'Affiliation': 'Bryn Mawr Hospital, Bryn Mawr, PA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Levicoff', 'Affiliation': 'Rothman Orthopaedic Institute, Bryn Mawr Hospital, Bryn Mawr, PA.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.04.017']
1198,31053468,Component Placement in Direct Lateral vs Minimally Invasive Anterior Approach in Total Hip Arthroplasty: Radiographic Outcomes From a Prospective Randomized Controlled Trial.,"BACKGROUND


End-stage coxarthrosis is increasingly common; however, limited evidence exists on the effect of direct lateral approach (DLA) and minimally invasive direct anterior approach (MIDA) on component placement in total hip arthroplasty (THA). We therefore conducted a prospective, randomized controlled trial to determine the component placement in DLA vs MIDA in THA.
METHODS


Between January 2012 and June 2013, 164 patients with clinically and radiologically confirmed coxarthrosis aged 20-80 years were randomized to either DLA or MIDA (active comparator). Excluded were patients with previous ipsilateral hip surgery, a body mass index >35 kg/m 2 , and/or mental disability. Primary clinical outcomes have been published elsewhere. Secondary outcomes included radiographic assessment of the acetabular component (cement-mantle thickness, inclination, and anteversion), femoral stem position (varus/valgus and THA index), offset restoration, and leg length discrepancy.
RESULTS


The mean cement-mantle was significantly thicker in zone 1 in the MIDA group (mean difference = 0.51 mm, 95% confidence interval [CI] 0.09-0.93, P = .018), and the mean degrees of inclination and anteversion were higher in the MIDA group (mean difference = 2.5°, 95% CI 0.3-4.6, P = .023 and mean difference = 3.6°, 95% CI 2.2-5.0, P < .0001, respectively). According to the defined reference range, cup inclination was more often adequate in the DLA group (67.9% (53/78) in the DLA group vs 52.4% (43/82) in the MIDA group, P = .045). There were no differences in frontal or lateral femoral stem position, global offset restoration, or leg length discrepancy.
CONCLUSION


In this population of Norwegian patients with coxarthrosis, radiographic assessment showed limited differences in component placement between MIDA and DLA. The findings suggest that component placement is similar in the 2 surgical approaches.",2019,"The mean cement-mantle was significantly thicker in zone 1 in the MIDA group (mean difference = 0.51 mm, 95% confidence interval [CI] 0.09-0.93, P = .018), and the mean degrees of inclination and anteversion were higher in the MIDA group (mean difference =","['Between January 2012 and June 2013, 164 patients with clinically and radiologically confirmed coxarthrosis aged 20-80 years', 'Total Hip Arthroplasty', 'total hip arthroplasty (THA', 'Excluded were patients with previous ipsilateral hip surgery, a body mass index >35 kg/m 2 , and/or mental disability']","['Component Placement in Direct Lateral vs Minimally Invasive Anterior Approach', 'DLA or MIDA (active comparator', 'direct lateral approach (DLA) and minimally invasive direct anterior approach (MIDA']","['radiographic assessment of the acetabular component (cement-mantle thickness, inclination, and anteversion), femoral stem position (varus/valgus and THA index), offset restoration, and leg length discrepancy', 'mean cement-mantle', 'mean degrees of inclination and anteversion', 'frontal or lateral femoral stem position, global offset restoration, or leg length discrepancy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0029410', 'cui_str': 'Coxarthrosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1306341', 'cui_str': 'Mental handicap (finding)'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach (qualifier value)'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0333053', 'cui_str': 'Anteversion (morphologic abnormality)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0443345', 'cui_str': 'Varus (qualifier value)'}, {'cui': 'C0443344', 'cui_str': 'Valgus (qualifier value)'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0426952', 'cui_str': 'Leg length (observable entity)'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",164.0,0.164628,"The mean cement-mantle was significantly thicker in zone 1 in the MIDA group (mean difference = 0.51 mm, 95% confidence interval [CI] 0.09-0.93, P = .018), and the mean degrees of inclination and anteversion were higher in the MIDA group (mean difference =","[{'ForeName': 'Ole-Christian L', 'Initials': 'OL', 'LastName': 'Brun', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ulleval, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Helge N', 'Initials': 'HN', 'LastName': 'Sund', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ulleval, Oslo, Norway; Sorlandet Hospital HF, Arendal, Kristiansand, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nordsletten', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ulleval, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Röhrl', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ulleval, Oslo, Norway.'}, {'ForeName': 'Knut E', 'Initials': 'KE', 'LastName': 'Mjaaland', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Sorlandet Hospital HF, Arendal, Kristiansand, Norway.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.04.003']
1199,31330149,The acute influence of sucrose consumption with and without vitamin C co-ingestion on microvascular reactivity in healthy young adults.,"BACKGROUND


Sugar sweetened beverages (SSB) are a major source of dietary sugar and a public health concern. Glucose consumption acutely influences microvascular reactivity in healthy adults, possibly via oxidative stress. The purpose of this study was to observe the acute influence of a more relevant dose of sucrose on microvascular reactivity, and to identify whether this response is influenced by the amount of vitamin C typically contained in SSB.
METHODS


Thirteen ostensibly healthy adults (8 male, 5 female) performed three 1-day trials in a randomized order; the consumption of 300 ml water (control; CON), or 300 ml water with 50 g sucrose (SUGAR) or 50 g sucrose with 160 mg of vitamin C (VITC). Near infrared spectroscopy was used to determine peak reactive hyperaemia (PRH), the rate of desaturation (Slope 1) and reperfusion (Slope 2), and the total area under the reperfusion curve versus time (TRH) following 5 min of forearm cuff occlusion before and 30, 60, 90 and 120 min after test drink consumption.
RESULTS


SUGAR and VITC significantly increased the total area under the curve versus time for plasma glucose (P < 0.05 for both). No changes in microvascular reactivity were observed between trials, although VITC increased Slope 1 compared to both SUGAR and CON 30 and 60 min post drink (P < 0.05 for both).
CONCLUSION


The consumption of a sugar load representative of commercially available SSB did not influence microvascular reactivity. The co-ingestion of Vitamin C also failed to influence microvascular reactivity, but did increase the rate of oxygen extraction.",2019,"RESULTS


SUGAR and VITC significantly increased the total area under the curve versus time for plasma glucose (P < 0.05 for both).","['healthy young adults', 'healthy adults', 'Thirteen ostensibly healthy adults (8 male, 5 female']","['consumption of 300\u202fml water (control; CON), or 300\u202fml water with 50\u202fg sucrose (SUGAR) or 50\u202fg sucrose with 160\u202fmg of vitamin C (VITC', 'Glucose consumption acutely', 'sucrose consumption with and without vitamin C co-ingestion', 'Vitamin C', 'Sugar sweetened beverages (SSB', 'SUGAR and CON']","['total area under the curve versus time for plasma glucose', 'microvascular reactivity', 'rate of oxygen extraction', 'peak reactive hyperaemia (PRH), the rate of desaturation (Slope 1) and reperfusion (Slope 2), and the total area under the reperfusion curve versus time (TRH']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0040162', 'cui_str': 'protirelin'}]",,0.0900819,"RESULTS


SUGAR and VITC significantly increased the total area under the curve versus time for plasma glucose (P < 0.05 for both).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'West', 'Affiliation': 'College of Life and Environmental Sciences at the University of Exeter, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Smail', 'Affiliation': 'College of Life and Environmental Sciences at the University of Exeter, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bond', 'Affiliation': 'College of Life and Environmental Sciences at the University of Exeter, United Kingdom of Great Britain and Northern Ireland. Electronic address: b.bond@exeter.ac.uk.'}]",Microvascular research,['10.1016/j.mvr.2019.103906']
1200,31324354,Randomized Prospective Comparative Study of Adductor Canal Block vs Periarticular Infiltration on Early Functional Outcome After Unilateral Total Knee Arthroplasty.,"BACKGROUND


Total knee arthroplasty (TKA) is associated with significant postoperative pain. Effective pain relief is essential for early postoperative rehabilitation. Periarticular infiltration (PAI) and adductor canal block (ACB) have become popular modes of pain management after TKA. Our aim is to compare their efficacy and impact on early functional outcome in patients undergoing TKA.
METHODS


A single-blinded randomized controlled trial, 100 patients undergoing unilateral primary TKA for symptomatic osteoarthritis were allocated to either of the 2 groups (50 in each arm): postoperative ultrasound-guided single shot of ACB (group A) or intraoperative PAI (group B). All patients underwent TKA without patella resurfacing under spinal anesthesia. Preoperative workup, surgical technique, and postoperative management were standardized for all the patients. Patients were assessed for pain using visual analogue scale at 6, 12, and 24 hours after surgery; hemoglobin level preoperatively and postoperatively on day 1 to calculate blood loss; hospital stay; tourniquet time; operative time; and postoperative complications by an independent observer blinded to the group allocation.
RESULTS


Patients were matched for age, gender, American Society of Anesthesiologists grade, and deformity. Visual analogue scale (scale 0-10) between PAI and ACB at 6, 12, and 24 hours were significantly different (P < .05) with higher scores seen in patients with ACB at all time points. Tourniquet time and operative time were significantly longer in the PAI than ACB. No significant difference in hospital stay was observed. No complications occurred during the study.
CONCLUSION


PAI achieves better pain control as compared to ACB in patients undergoing unilateral TKA.",2019,Tourniquet time and operative time were significantly longer in the PAI than ACB.,"['patients undergoing unilateral TKA', 'Patients were matched for age, gender, American Society of Anesthesiologists grade, and deformity', '100 patients undergoing unilateral primary TKA for symptomatic osteoarthritis', 'patients undergoing TKA', 'After Unilateral Total Knee Arthroplasty']","['Adductor Canal Block vs Periarticular Infiltration', 'postoperative ultrasound-guided single shot of ACB (group A) or intraoperative PAI', 'ACB', 'Total knee arthroplasty (TKA', 'TKA without patella resurfacing under spinal anesthesia', 'PAI']","['hospital stay', 'Tourniquet time and operative time', 'complications', 'Visual analogue scale', 'pain using visual analogue scale', 'blood loss; hospital stay; tourniquet time; operative time; and postoperative complications', 'Early Functional Outcome', 'Periarticular infiltration (PAI) and adductor canal block (ACB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030647', 'cui_str': 'Kneecap'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0428724', 'cui_str': 'Duration of tourniquet inflation (observable entity)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",100.0,0.0627325,Tourniquet time and operative time were significantly longer in the PAI than ACB.,"[{'ForeName': 'Mahesh M', 'Initials': 'MM', 'LastName': 'Kulkarni', 'Affiliation': 'Department of Joint Replacement, Deenanath Mangeshkar Hospital and Research Center, Pune, India.'}, {'ForeName': 'Ankit N', 'Initials': 'AN', 'LastName': 'Dadheech', 'Affiliation': 'Department of Joint Replacement, Deenanath Mangeshkar Hospital and Research Center, Pune, India.'}, {'ForeName': 'Hemant M', 'Initials': 'HM', 'LastName': 'Wakankar', 'Affiliation': 'Department of Joint Replacement, Deenanath Mangeshkar Hospital and Research Center, Pune, India.'}, {'ForeName': 'Niranjan V', 'Initials': 'NV', 'LastName': 'Ganjewar', 'Affiliation': 'Department of Joint Replacement, Deenanath Mangeshkar Hospital and Research Center, Pune, India.'}, {'ForeName': 'Snehal S', 'Initials': 'SS', 'LastName': 'Hedgire', 'Affiliation': 'Department of Joint Replacement, Deenanath Mangeshkar Hospital and Research Center, Pune, India.'}, {'ForeName': 'Hemant G', 'Initials': 'HG', 'LastName': 'Pandit', 'Affiliation': 'LEEDS Institute of Rheumatic and Musculoskeletal Medicine, University of LEEDS, Leeds, UK.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.05.049']
1201,31328399,Unconditional and conditional monetary incentives to increase response to mailed questionnaires: A randomized controlled study within a trial (SWAT).,"RATIONALE, AIMS, AND OBJECTIVES


High response rates to research questionnaires can help to ensure results are more representative of the population studied and provide increased statistical power, on which the study may have been predicated. Improving speed and quality of response can reduce costs.
METHOD


We conducted a randomized study within a trial (SWAT) to assess questionnaire response rates, reminders sent, and data completeness with unconditional compared with conditional monetary incentives. Eligible individuals were mailed a series of psychological questionnaires as a follow-up to a baseline host trial questionnaire. Half received a £5 gift voucher with questionnaires (unconditional), and half were promised the voucher after returning questionnaires (conditional).
RESULTS


Of 1079 individuals, response rates to the first follow-up questionnaire were 94.2% and 91.7% in the unconditional and conditional monetary incentive groups, respectively (OR 1.78; 95% CI, 0.85-3.72). There were significantly greater odds of returning repeat questionnaires in the unconditional group at 6 months (OR 2.97; 95% CI, 1.01-8.71; .047) but not at 12 months (OR 1.12; 95% CI, 0.44-2.85). Incentive condition had no impact at any time point on the proportion of sent questionnaires that needed reminders. Odds of incomplete questionnaires were significantly greater at 3 months in the unconditional compared with the conditional incentive group (OR 2.45; 95% CI, 1.32-4.55; .004).
CONCLUSIONS


Unconditional monetary incentives can produce a transitory greater likelihood of mailed questionnaire response in a clinical trial participant group, consistent with the direction of effect in other settings. However, this could have been a chance finding. The use of multiple strategies to promote response may have created a ceiling effect. This strategy has potential to reduce administrative and postage costs, weighed against the cost of incentives used, but could risk compromising the completeness of data.",2020,"Odds of incomplete questionnaires were significantly greater at 3 months in the unconditional compared with the conditional incentive group (OR 2.45; 95% CI, 1.32-4.55; .004).
","['mailed questionnaires', '1079 individuals']",[],"['odds of returning repeat questionnaires', 'Odds of incomplete questionnaires', 'response rates to the first follow-up questionnaire']","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",1079.0,0.048489,"Odds of incomplete questionnaires were significantly greater at 3 months in the unconditional compared with the conditional incentive group (OR 2.45; 95% CI, 1.32-4.55; .004).
","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Young', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bedford', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'das Nair', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gallant', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Littleford', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'John F R', 'Initials': 'JFR', 'LastName': 'Robertson', 'Affiliation': 'Division of Medical Sciences and Graduate Entry Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Schembri', 'Affiliation': 'Respiratory Department, Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, University of St Andrews, St Andrews, UK.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Vedhara', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Kendrick', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of evaluation in clinical practice,['10.1111/jep.13230']
1202,31325313,An investigation of the effects of procalcitonin testing on antimicrobial prescribing in respiratory tract infections in an Irish university hospital setting: a feasibility study.,"BACKGROUND


Diagnostic uncertainty and a high prevalence of viral infections present unique challenges for antimicrobial prescribing for respiratory tract infections (RTIs). Procalcitonin (PCT) has been shown to support prescribing decisions and reduce antimicrobial use safely in patients with RTIs, but recent study results have been variable.
METHODS


We conducted a feasibility study of the introduction of PCT testing in patients admitted to hospital with a lower RTI to determine if PCT testing is an effective and worthwhile intervention to introduce to support the existing antimicrobial stewardship (AMS) programme and safely decrease antimicrobial prescribing in patients admitted with RTIs.
RESULTS


A total of 79 patients were randomized to the intervention PCT-guided treatment group and 40 patients to the standard care respiratory control group. The addition of PCT testing led to a significant decrease in duration of antimicrobial prescriptions (mean 6.8 versus 8.9 days, P = 0.012) and decreased length of hospital stay (median 7 versus 8 days, P = 0.009) between the PCT and respiratory control group. PCT did not demonstrate a significant reduction in antimicrobial consumption when measured as DDDs and days of therapy.
CONCLUSIONS


PCT testing had a positive effect on antimicrobial prescribing during this feasibility study. The successful implementation of PCT testing in a randomized controlled trial requires an ongoing comprehensive education programme, greater integration into the AMS programme and delivery of PCT results in a timely manner. This feasibility study has shown that a larger randomized controlled trial would be beneficial to further explore the positive aspects of these findings.",2019,"Procalcitonin (PCT) has been shown to support prescribing decisions and reduce antimicrobial use safely in patients with RTIs, but recent study results have been variable.
","['79 patients', 'respiratory tract infections in an Irish university hospital setting', 'patients with RTIs', 'patients admitted with RTIs', 'patients admitted to hospital with a lower RTI']","['procalcitonin testing', 'intervention PCT-guided treatment group and 40 patients to the standard care respiratory control group', 'Procalcitonin (PCT', 'antimicrobial stewardship (AMS) programme', 'PCT']","['length of hospital stay', 'antimicrobial consumption', 'duration of antimicrobial prescriptions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0422794', 'cui_str': 'Irish (NMO) (ethnic group)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",79.0,0.0643984,"Procalcitonin (PCT) has been shown to support prescribing decisions and reduce antimicrobial use safely in patients with RTIs, but recent study results have been variable.
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': ""O'Riordan"", 'Affiliation': 'Pharmacy Department, Mercy University Hospital, Grenville Place, Cork, Ireland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Shiely', 'Affiliation': 'HRB Clinical Research Facility Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'Clinical Pharmacy Research Group, School of Pharmacy, University College Cork, Cork, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Microbiology, Mercy University Hospital, Grenville Place, Cork, Ireland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Palmer', 'Affiliation': 'HRB Clinical Research Facility Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dahly', 'Affiliation': 'HRB Clinical Research Facility Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Respiratory Medicine, Mercy University Hospital, Grenville Place, Cork, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Curran', 'Affiliation': 'Department of Respiratory Medicine, Mercy University Hospital, Grenville Place, Cork, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fleming', 'Affiliation': 'Pharmacy Department, Mercy University Hospital, Grenville Place, Cork, Ireland.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz313']
1203,31060845,Feasibility of a Modified Strategy for 2-Rescuer Cardiopulmonary Resuscitation.,"BACKGROUND


Cardiopulmonary resuscitation (CPR) requires effective chest compressions and ventilations to circulate and oxygenate blood. It has been established that a 2-handed mask seal is superior when providing bag-valve-mask (BVM) ventilations. However a 1-handed technique remains the standard with which health care providers are trained to perform 2-rescuer CPR.
OBJECTIVES


We sought to determine if a modified 2-rescuer CPR technique that incorporates a 2-handed mask seal during ventilations can be accomplished without compromising chest compression quality during a simulated cardiac arrest.
METHODS


Medical student volunteers were divided into an ""intervention"" arm, with 1 rescuer creating a 2-handed mask seal and the second rescuer performing chest compressions followed by that second rescuer squeezing the BVM bag to deliver ventilations during compression pauses, and a ""control"" arm, in which standard 2-rescuer CPR was performed. Both arms received a brief CPR refresher following a standard script. The 2 rescuer teams then performed 2 rounds of CPR on a manikin while being video recorded. Data were collected from real-time evaluation and post hoc video analysis.
RESULTS


Forty-seven pairs of students enrolled in the study. There were no statistically significant differences between the intervention and control arms for median (interquartile range [IQR]) compression fraction (72% [69.5-75.7%] vs. 73.2% [69.1-76.1%]; p = 1.0), median time to complete 2 rounds of CPR (207.8 s [198.5-222.9 s] vs. 214.7 s [201.3-219.5 s]; p = 0.625), median hands-off time (49.8 s [46.2-63.0 s] vs. 55.4 s [50.4-65.2 s]; p = 0.278), or median time for 30 compressions (15.2 s [14.3-15.9 s] vs. 15.4 s [14.6-16.3 s]; p = 0.452).
CONCLUSION


Two-rescuer CPR incorporating a 2-handed face mask seal can be performed effectively without impacting chest compression quality during simulated cardiac arrest.",2019,"There were no statistically significant differences between the intervention and control arms for median (interquartile range [IQR]) compression fraction (72% [69.5-75.7%] vs. 73.2% [69.1-76.1%]; p = 1.0), median time to complete 2 rounds of CPR (207.8 s [198.5-222.9 s] vs. 214.7 s [201.3-219.5 s]; p = ","['Medical student volunteers', 'Forty-seven pairs of students enrolled in the study']","['intervention"" arm, with 1 rescuer creating a 2-handed mask seal and the second rescuer performing chest compressions followed by that second rescuer squeezing the BVM bag to deliver ventilations during compression pauses, and a ""control"" arm', 'Cardiopulmonary resuscitation (CPR']","['median time to complete 2 rounds of CPR', 'median hands-off time', 'median (interquartile range [IQR]) compression fraction']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent (disorder)'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",,0.018508,"There were no statistically significant differences between the intervention and control arms for median (interquartile range [IQR]) compression fraction (72% [69.5-75.7%] vs. 73.2% [69.1-76.1%]; p = 1.0), median time to complete 2 rounds of CPR (207.8 s [198.5-222.9 s] vs. 214.7 s [201.3-219.5 s]; p = ","[{'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Root', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Deutsch', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Lakha', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Hung Mo', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jaime B', 'Initials': 'JB', 'LastName': 'Hyman', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2019.03.009']
1204,31324597,"Pre-emptive intervention versus treatment as usual for infants showing early behavioural risk signs of autism spectrum disorder: a single-blind, randomised controlled trial.","BACKGROUND


Great interest exists in the potential efficacy of prediagnostic interventions within the autism spectrum disorder prodrome, but available evidence relates to children at high familial risk. We aimed to test the efficacy of a pre-emptive intervention designed for infants showing early behavioural signs of autism spectrum disorder.
METHODS


In this single-blind, randomised controlled trial done at two specialist centres in Australia, infants aged 9-14 months were enrolled if they were showing at least three early behavioural signs of autism spectrum disorder on the Social Attention and Communication Surveillance-Revised (SACS-R) 12-month checklist. Infants were randomly assigned (1:1) to receive a parent-mediated video-aided intervention (iBASIS-VIPP) or treatment as usual. Group allocation was done by minimisation, stratified by site, sex, age, and the number of SACS-R risk behaviours. Assessments were done at baseline (before treatment allocation) and at the 6 month endpoint. The primary outcome was Autism Observation Scale for Infants (AOSI), which measures early behavioural signs associated with autism spectrum disorder. Secondary outcomes were a range of infant and caregiver outcomes measured by Manchester Assessment of Caregiver-Infant interaction (MACI), Mullen Scales of Early Learning (MSEL), Vineland Adaptive Behaviour Scales, 2nd edition (VABS-2), MacArthur-Bates Communicative Development Inventory (MCDI), and Parenting Sense of Competence (PSOC) scale. This trial is registered with Australian New Zealand Clinical Trials Registry, number ANZCTR12616000819426.
FINDINGS


Between June 9, 2016, and March 30, 2018, 103 infants were randomly assigned, 50 to the iBASIS-VIPP group and 53 to the treatment-as-usual group. After the intervention, we observed no significant differences between groups on early autism spectrum disorder behavioural signs measured by the AOSI (difference estimate -0·74, 95% CI -2·47 to 0·98). We also observed no significant differences on secondary outcomes measuring caregiver non-directiveness (0·16, -0·33 to 0·65), caregiver sensitive responding (0·24, -0·15 to 0·63), and infant attentiveness (-0·19, -0·63 to 0·25) during parent-child interactions (MACI), as well as on researcher-administered measures of receptive (1·30, -0·48 to 3·08) and expressive language (0·54, -0·73 to 1·80), visual reception (0·31, -0·77 to 1·40), and fine motor skills (0·55, -0·32 to 1·41) using the MSEL. Compared with the treatment-as-usual group, the iBASIS-VIPP group had lower infant positive affect (-0·69, -1·27 to -0·10) on the MACI, but higher caregiver-reported receptive (37·17, 95% CI 10·59 to 63·75) and expressive vocabulary count (incidence rate ratio 2·31, 95% CI 1·22 to 4·33) on MCDI, and functional language use (difference estimate 6·43, 95% CI 1·06 to 11·81) on VABS. There were no significant group differences on caregiver-reported measures of MCDI infant gesture use (3·22, -0·60 to 7·04) and VABS social behaviour (3·28, -1·43 to 7·99). We observed no significant differences between groups on self-reported levels of parenting satisfaction (difference estimate 0·21, 95% CI -0·09 to 0·52), interest (-0·23, -0·62 to 0·16) and efficacy (-0·08, -0·38 to 0·22) on PSOC.
INTERPRETATION


A pre-emptive intervention for the autism spectrum disorder prodrome had no immediate treatment effect on early autism spectrum disorder symptoms, the quality of parent-child interactions, or researcher-administered measures of developmental skills. However, we found a positive effect on parent-rated infant communication skills. Ongoing follow-up of this infant cohort will assess longer-term developmental effects.
FUNDING


Western Australia Children's Research Fund, Autism Cooperative Research Centre, La Trobe University, and Angela Wright Bennett Foundation.",2019,"After the intervention, we observed no significant differences between groups on early autism spectrum disorder behavioural signs measured by the AOSI (difference estimate -0·74, 95% CI -2·47 to 0·98).","['infants showing early behavioural signs of autism spectrum disorder', 'infants showing early behavioural risk signs of autism spectrum disorder', 'Between June 9, 2016, and March 30, 2018', 'two specialist centres in Australia, infants aged 9-14 months were enrolled if they were showing at least three early behavioural signs of autism spectrum disorder on the Social Attention and Communication Surveillance-Revised (SACS-R) 12-month checklist', '103 infants']","['pre-emptive intervention', 'prediagnostic interventions', 'parent-mediated video-aided intervention (iBASIS-VIPP) or treatment as usual', 'Pre-emptive intervention', 'iBASIS-VIPP']","['parenting satisfaction', 'early autism spectrum disorder behavioural signs', 'MCDI, and functional language use', 'Autism Observation Scale for Infants (AOSI), which measures early behavioural signs associated with autism spectrum disorder', 'range of infant and caregiver outcomes measured by Manchester Assessment of Caregiver-Infant interaction (MACI), Mullen Scales of Early Learning (MSEL), Vineland Adaptive Behaviour Scales, 2nd edition (VABS-2), MacArthur-Bates Communicative Development Inventory (MCDI), and Parenting Sense of Competence (PSOC) scale', 'MCDI infant gesture use (3·22, -0·60 to 7·04) and VABS social behaviour', 'VABS', 'secondary outcomes measuring caregiver non-directiveness (0·16, -0·33 to 0·65), caregiver sensitive responding (0·24, -0·15 to 0·63), and infant attentiveness (-0·19, -0·63 to 0·25) during parent-child interactions (MACI), as well as on researcher-administered measures of receptive (1·30, -0·48 to 3·08) and expressive language (0·54, -0·73 to 1·80), visual reception (0·31, -0·77 to 1·40), and fine motor skills']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1444514', 'cui_str': 'Communication surveillance'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0222045'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales (assessment scale)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0037397', 'cui_str': 'Social Behavior'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0233413', 'cui_str': 'Attentiveness (observable entity)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",103.0,0.392064,"After the intervention, we observed no significant differences between groups on early autism spectrum disorder behavioural signs measured by the AOSI (difference estimate -0·74, 95% CI -2·47 to 0·98).","[{'ForeName': 'Andrew J O', 'Initials': 'AJO', 'LastName': 'Whitehouse', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia; Cooperative Research Centre for Living with Autism (Autism CRC), Indooroopilly, QLD, Australia. Electronic address: andrew.whitehouse@telethonkids.org.au.'}, {'ForeName': 'Kandice J', 'Initials': 'KJ', 'LastName': 'Varcin', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Gail A', 'Initials': 'GA', 'LastName': 'Alvares', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Barbaro', 'Affiliation': 'Cooperative Research Centre for Living with Autism (Autism CRC), Indooroopilly, QLD, Australia; Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bent', 'Affiliation': 'Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Boutrus', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia; Cooperative Research Centre for Living with Autism (Autism CRC), Indooroopilly, QLD, Australia; School of Psychological Science, University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Chetcuti', 'Affiliation': 'Cooperative Research Centre for Living with Autism (Autism CRC), Indooroopilly, QLD, Australia; Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Cooper', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Davidson', 'Affiliation': 'Child and Adolescent Health Service, Child Development Service, West Perth, WA, Australia.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Dimov', 'Affiliation': 'Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Dissanayake', 'Affiliation': 'Cooperative Research Centre for Living with Autism (Autism CRC), Indooroopilly, QLD, Australia; Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Doyle', 'Affiliation': 'Child and Adolescent Health Service, Child Development Service, West Perth, WA, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Grant', 'Affiliation': 'Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Iacono', 'Affiliation': 'La Trobe Rural Health School, Bendigo, VIC, Australia.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Maybery', 'Affiliation': 'School of Psychological Science, University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pillar', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Renton', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia; Child and Adolescent Health Service, Child Development Service, West Perth, WA, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Rowbottam', 'Affiliation': 'Child and Adolescent Health Service, Child Development Service, West Perth, WA, Australia.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Sadka', 'Affiliation': 'Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Segal', 'Affiliation': 'Australian Centre for Precision Health, School of Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Slonims', 'Affiliation': ""Children's Neurosciences, Evelina London Children's Hospital, Institute of Psychiatry, Psychology & Neuroscience, Kings College London, London, UK.""}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wakeling', 'Affiliation': 'Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Ming Wai', 'Initials': 'MW', 'LastName': 'Wan', 'Affiliation': 'School of Health Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wray', 'Affiliation': 'Child and Adolescent Health Service, Child Development Service, West Perth, WA, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, University of Manchester, Manchester, UK; Manchester Academic Health Science Centre, Manchester University NHS Foundation Trust, Greater Manchester Mental Health NHS Trust, Manchester, UK.'}, {'ForeName': 'Kristelle', 'Initials': 'K', 'LastName': 'Hudry', 'Affiliation': 'Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(19)30184-1']
1205,32109176,A Randomized Controlled Trial Investigating Online Training for Prelinguistic Communication.,"Purpose This study explored the utility of online training as a platform for teaching early intervention speech-language pathologists to recognize potentially communicative, prelinguistic behaviors in young children with physical disabilities and complex communication needs. Method Using a randomized controlled trial, 45 early intervention speech-language pathologists were randomly assigned to one of three conditions within an online training: practice with implicit problem-solving (identification condition), practice with explicit problem-solving (reflection condition), or no practice (control condition). Knowledge about early communication, skill at recognizing prelinguistic behaviors, time taken to complete the training, and perceptions of the training experience were examined. Results Participants in the no-practice control condition took significantly less time to complete the training, achieved the same positive outcomes on the knowledge and skill assessments, and rated the training as appealing as compared with participants assigned to the more time-intensive identification and reflection practice conditions. Conclusions Results suggest the importance of considering efficiency and appeal when designing successful trainings for moving evidence into practice.",2020,"Results Participants in the no-practice control condition took significantly less time to complete the training, achieved the same positive outcomes on the knowledge and skill assessments, and rated the training as appealing as compared with participants assigned to the more time-intensive identification and reflection practice conditions.","['young children with physical disabilities and complex communication needs', '45 early intervention speech-language pathologists']","['online training: practice with implicit problem-solving (identification condition), practice with explicit problem-solving (reflection condition), or no practice (control condition', 'Online Training', 'online training']",[],"[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0242687', 'cui_str': 'Early Intervention'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0334866', 'cui_str': 'Pathologists'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],45.0,0.033264,"Results Participants in the no-practice control condition took significantly less time to complete the training, achieved the same positive outcomes on the knowledge and skill assessments, and rated the training as appealing as compared with participants assigned to the more time-intensive identification and reflection practice conditions.","[{'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Feuerstein', 'Affiliation': 'School of Communication Sciences and Disorders, College of Health Professions and Sciences, University of Central Florida, Orlando.'}, {'ForeName': 'Lesley B', 'Initials': 'LB', 'LastName': 'Olswang', 'Affiliation': 'Department of Speech and Hearing Sciences, University of Washington, Seattle.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-19-00336']
1206,31262585,Safety and immunogenicity of hepatitis E vaccine in elderly people older than 65 years.,"BACKGROUND


Hepatitis E virus (HEV) infection is a leading cause of acute hepatitis worldwide, and results in high morbidity and mortality rates among elderly people in China. The hepatitis E vaccine, Hecolin®, has been shown to be safe and highly efficacious among healthy adults aged 16-65 years old. However, there is no data about Hecolin® vaccination in elderly people older than 65 years (y).
METHODS


An open-labeled, controlled trial was conducted to evaluate the safety and immunogenicity of Hecolin® among the elderly aged >65 y. A total of 601 eligible participants were enrolled. Among them, 200 elderly people aged >65 y and 201 adults aged 18-65 y were assigned to the Hecolin® groups and vaccinated at day 0, month 1 and month 6. Serum samples were collected for anti-HEV IgG determination at day 0 prior to immunization and at month 7. The remaining 200 elderly people aged >65 y were assigned to the safety control group and received no intervention but were instructed to report any adverse events that occurred during the whole study period in the same way as those in the Hecolin® groups.
RESULTS


After receiving 3 doses of Hecolin® with the standard schedule, most (96.7%) of the vaccinated elderly people aged >65 y seroconverted at one month after the final dose (month 7). At month 7, the geometric mean concentrations of anti-HEV IgG were 5.36 (95% CI, 3.88-7.41) and 19.65 (95% CI, 16.81-22.98) among the baseline seronegative and seropositive elderly, respectively. Of the vaccinated elderly, 97.3% (177/182) had anti-HEV IgG levels higher than 1.0 WU/ml at month 7. Hecolin® was very well tolerated in this population. No vaccine-related SAEs were reported.
CONCLUSIONS


Hecolin® is immunogenic and well tolerated in elderly people aged greater than 65 years.",2019,"Of the vaccinated elderly, 97.3% (177/182) had anti-HEV IgG levels higher than 1.0 WU/ml at month 7.","['200 elderly people aged >65 y and 201 adults aged', 'elderly aged ', '18-65 y', '601 eligible participants were enrolled', 'elderly people aged greater than 65\u202fyears', 'healthy adults aged 16-65\u202fyears old', 'elderly people older than 65\u202fyears', 'elderly people in China', 'elderly people older than 65\u202fyears (y', '65', '200 elderly people aged >65 y']","['hepatitis E vaccine', 'Hecolin®']","['Safety and immunogenicity', 'anti-HEV IgG levels', 'safety and immunogenicity', 'geometric mean concentrations of anti-HEV IgG']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0085293', 'cui_str': 'Hepatitis, Water-Borne'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C3529763', 'cui_str': 'hecolin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0312636', 'cui_str': 'Antibody to hepatitis E virus'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",601.0,0.0562446,"Of the vaccinated elderly, 97.3% (177/182) had anti-HEV IgG levels higher than 1.0 WU/ml at month 7.","[{'ForeName': 'Xu-Ya', 'Initials': 'XY', 'LastName': 'Yu', 'Affiliation': 'Xiamen Innovax Biotech Co.Ltd, Xiamen 361022, China.'}, {'ForeName': 'Zhi-Ping', 'Initials': 'ZP', 'LastName': 'Chen', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'Shen-Yu', 'Initials': 'SY', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'Hui-Rong', 'Initials': 'HR', 'LastName': 'Pan', 'Affiliation': 'Xiamen Innovax Biotech Co.Ltd, Xiamen 361022, China.'}, {'ForeName': 'Zhi-Fang', 'Initials': 'ZF', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'Qiu-Fen', 'Initials': 'QF', 'LastName': 'Zhang', 'Affiliation': 'Xiamen Innovax Biotech Co.Ltd, Xiamen 361022, China.'}, {'ForeName': 'Ling-Zhi', 'Initials': 'LZ', 'LastName': 'Shen', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'Xiao-Ping', 'Initials': 'XP', 'LastName': 'Zheng', 'Affiliation': 'Kaihua Center for Disease Control and Prevention, Quzhou 324300, China.'}, {'ForeName': 'Chuan-Fu', 'Initials': 'CF', 'LastName': 'Yan', 'Affiliation': 'Kaihua Center for Disease Control and Prevention, Quzhou 324300, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Kaihua Center for Disease Control and Prevention, Quzhou 324300, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Kaihua Center for Disease Control and Prevention, Quzhou 324300, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen 361005, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen 361005, China.'}, {'ForeName': 'Hua-Kun', 'Initials': 'HK', 'LastName': 'Lv', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, China. Electronic address: hklv@cdc.zj.cn.'}, {'ForeName': 'Shou-Jie', 'Initials': 'SJ', 'LastName': 'Huang', 'Affiliation': 'National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen 361005, China. Electronic address: huangshoujie@xmu.edu.cn.'}]",Vaccine,['10.1016/j.vaccine.2019.04.006']
1207,31318615,Dietary nitrate supplementation enhances cerebrovascular CO 2  reactivity in a sex-specific manner.,"Insufficient nitric oxide (NO) bioavailability plays an important role in endothelial dysfunction, and increased NO has the potential to enhance cerebral blood flow (CBF). Dietary supplementation with sodium nitrate, a precursor of NO, could improve cerebrovascular function, but this has not been investigated. In 17 individuals, we examined the effects of a 7-day supplementation of dietary nitrate (0.1 mmol·kg -1 ·day  -1 ) on cerebrovascular function using a randomized, single-blinded placebo-controlled crossover design. We hypothesized that 7-day dietary nitrate supplementation increases CBF response to CO 2  (cerebrovascular CO 2  reactivity) and cerebral autoregulation (CA). We assessed middle cerebral artery blood velocity (MCAv) and blood pressure (BP) at rest and during CO 2  breathing. Transfer function analysis was performed on resting beat-to-beat MCAv and BP to determine CA, from which phase, gain, and coherence of the BP-MCAv data were derived. Dietary nitrate elevated plasma nitrate concentration by ~420% ( P  < 0.001) and lowered gain ( d  = 1.2,  P  = 0.025) and phase of the BP-MCAv signal compared with placebo treatment ( d  = 0.7,  P  = 0.043), while coherence was unaffected ( P  = 0.122). Dietary nitrate increased the MCAv-CO 2  slope in a sex-specific manner (interaction:  P  = 0.016). Dietary nitrate increased the MCAv-CO 2  slope in men ( d  = 1.0,  P  = 0.014 vs. placebo), but had no effect in women ( P  = 0.919). Our data demonstrate that dietary nitrate greatly increased cerebrovascular CO 2  reactivity in healthy individuals, while its effect on CA remains unclear. The selective increase in the MCAv-CO 2  slope observed in men indicates a clear sexual dimorphic role of NO in cerebrovascular function. NEW & NOTEWORTHY  We found dietary nitrate supplementation improved the brain blood vessels' response to CO 2 , cerebrovascular CO 2  reactivity, without affecting blood pressure in a group of healthy individuals. Meanwhile, the effect of dietary nitrate on the relationship between blood pressure and brain blood flow, cerebral autoregulation, was inconclusive. The improvement in cerebrovascular CO 2  reactivity was only observed in the male participants, alluding to a sex difference in the effect of dietary nitrate on brain blood flow control. Our findings indicate that dietary nitrate could be an effective strategy to enhance cerebrovascular CO 2  reactivity.",2019,"Dietary nitrate elevated plasma nitrate concentration by ˜420% ( P <0.001) and lowered gain ( d  = 1.2,  P  = 0.025) and phase of the BP-MCAv signal compared to placebo treatment ( d =0.7,  P =0.043), while coherence was unaffected ( P =0.122).","['seventeen individuals', 'healthy individuals']","['7-day dietary nitrate supplementation', 'placebo', 'Insufficient nitric oxide ', 'dietary nitrate', 'Dietary nitrate supplementation']","['Dietary nitrate increased the MCAv-CO 2  slope', 'cerebral blood flow (CBF', 'CBF response to CO 2  (cerebrovascular CO 2  reactivity) and cerebral autoregulation (CA', 'middle cerebral artery blood velocity (MCAv) and blood pressure (BP', 'Dietary nitrate elevated plasma nitrate concentration', 'lowered gain', 'cerebrovascular function', 'BP-MCAv signal']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0031843', 'cui_str': 'function'}]",17.0,0.0307434,"Dietary nitrate elevated plasma nitrate concentration by ˜420% ( P <0.001) and lowered gain ( d  = 1.2,  P  = 0.025) and phase of the BP-MCAv signal compared to placebo treatment ( d =0.7,  P =0.043), while coherence was unaffected ( P =0.122).","[{'ForeName': 'Jui-Lin', 'Initials': 'JL', 'LastName': 'Fan', 'Affiliation': 'Wellington Medical Technology Group, Department of Surgery and Anaesthesia, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Terrence', 'Initials': 'T', 'LastName': ""O'Donnell"", 'Affiliation': 'Wellington Medical Technology Group, Department of Surgery and Anaesthesia, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Clint Lee', 'Initials': 'CL', 'LastName': 'Gray', 'Affiliation': 'Centre for Translational Physiology, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Croft', 'Affiliation': 'School of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Annabel Kate', 'Initials': 'AK', 'LastName': 'Noakes', 'Affiliation': 'Wellington Medical Technology Group, Department of Surgery and Anaesthesia, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Henrietta', 'Initials': 'H', 'LastName': 'Koch', 'Affiliation': 'School of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Yu-Chieh', 'Initials': 'YC', 'LastName': 'Tzeng', 'Affiliation': 'Wellington Medical Technology Group, Department of Surgery and Anaesthesia, University of Otago, Wellington, New Zealand.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.01116.2018']
1208,31303261,Strengthened Hippocampal Circuits Underlie Enhanced Retrieval of Extinguished Fear Memories Following Mindfulness Training.,"BACKGROUND


The role of hippocampus in context-dependent recall of extinction is well recognized. However, little is known about how intervention-induced changes in hippocampal networks relate to improvements in extinction learning. In this study, we hypothesized that mindfulness training creates an optimal exposure condition by heightening attention and awareness of present moment sensory experience, leading to enhanced extinction learning, improved emotion regulation, and reduced anxiety symptoms.
METHODS


We tested this hypothesis in a randomized controlled longitudinal study design using a 2-day fear conditioning and extinction protocol. The mindfulness training group included 42 participants (28 women) and the control group included 25 participants (15 women).
RESULTS


We show that mindfulness training is associated with differential engagement of the right supramarginal gyrus as well as hippocampal-cortical reorganization. We also report enhanced hippocampal connectivity to the primary sensory cortex during retrieval of extinguished stimuli following mindfulness training.
CONCLUSIONS


These findings suggest hippocampal-dependent changes in contextual retrieval as one plausible neural mechanism through which mindfulness-based interventions enhance fear extinction and foster stress resilience.",2019,We show that mindfulness training is associated with differential engagement of the right supramarginal gyrus as well as hippocampal-cortical reorganization.,['group included 42 participants (28 women) and the control group included 25 participants (15 women'],"['2-day fear conditioning and extinction protocol', 'mindfulness training']","['enhanced extinction learning, improved emotion regulation, and reduced anxiety symptoms']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",42.0,0.0226357,We show that mindfulness training is associated with differential engagement of the right supramarginal gyrus as well as hippocampal-cortical reorganization.,"[{'ForeName': 'Gunes', 'Initials': 'G', 'LastName': 'Sevinc', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: gsevinc@mgh.harvard.edu.'}, {'ForeName': 'Britta K', 'Initials': 'BK', 'LastName': 'Hölzel', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; Department of Neuroradiology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Greenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Gard', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Brunsch', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Javeria A', 'Initials': 'JA', 'LastName': 'Hashmi', 'Affiliation': 'Department of Anesthesia, Pain Management & Perioperative Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Vangel', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Orr', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Mohammed R', 'Initials': 'MR', 'LastName': 'Milad', 'Affiliation': 'Psychiatry Department, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Sara W', 'Initials': 'SW', 'LastName': 'Lazar', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.05.017']
1209,32161366,Oxytocin induces long-lasting adaptations within amygdala circuitry in autism: a treatment-mechanism study with randomized placebo-controlled design.,"Intranasal administration of the neuropeptide oxytocin (IN-OT) is increasingly explored as a potential treatment for targeting the core symptoms of autism spectrum disorder (ASD). To date, however, the impact of multiple-dose IN-OT treatment on human neural circuitry is largely unknown, and also the possibility that long-term IN-OT use may induce long-lasting neural adaptations remains unexplored. Using a double-blind, randomized, placebo-controlled, between-subject design (including 38 adult men with ASD), this treatment-mechanism study showed that 4 weeks of daily oxytocin administration (24 IU/day) significantly altered intrinsic (resting-state fMRI) functional connectivity of the amygdala to core regions of the ""social brain"" (particularly orbitofrontal cortex and superior temporal sulcus) up to 4 weeks and 1 year post treatment. The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors. These observations contribute to a deeper mechanistic understanding of the neural substrates that underlie behavioral effects of multiple-dose IN-OT treatment, and provide initial insights into the long-lasting neural consequences of chronic IN-OT use on amygdala circuitry. Future studies are however warranted to further elucidate the long-term impact of IN-OT treatment on human neural circuitry and its behavioral consequences.",2020,The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors.,"['38 adult men with ASD', 'autism']","['neuropeptide oxytocin (IN-OT', 'oxytocin', 'Oxytocin', 'placebo']","['altered intrinsic (resting-state fMRI) functional connectivity of the amygdala to core regions of the ""social brain"" (particularly orbitofrontal cortex and superior temporal sulcus']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0228237', 'cui_str': 'Structure of superior temporal sulcus'}]",38.0,0.130252,The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors.,"[{'ForeName': 'Kaat', 'Initials': 'K', 'LastName': 'Alaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium. Kaat.Alaerts@kuleuven.be.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bernaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Jellina', 'Initials': 'J', 'LastName': 'Prinsen', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Dillen', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Steyaert', 'Affiliation': 'Department of Neurosciences, Group Biomedical Sciences, Psychiatry Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wenderoth', 'Affiliation': 'Department of Health Sciences and Technology, Neural Control of Movement Lab, ETH Zurich, Zurich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0653-8']
1210,32208006,Use of an Online Crowdsourcing Platform to Assess Patient Comprehension of Radiology Reports and Colloquialisms.,"OBJECTIVE.  The purpose of this study was to use an online crowdsourcing platform to assess patient comprehension of five radiology reporting templates and radiology colloquialisms.  MATERIALS AND METHODS.  In this cross-sectional study, participants were surveyed as patient surrogates using a crowdsourcing platform. Two tasks were completed within two 48-hour time periods. For the first crowdsourcing task, each participant was randomly assigned a set of radiology reports in a constructed reporting template and subsequently tested for comprehension. For the second crowdsourcing task, each participant was randomly assigned a radiology colloquialism and asked to indicate whether the phrase indicated a normal, abnormal, or ambivalent finding.  RESULTS.  A total of 203 participants enrolled for the first task and 1166 for the second within 48 hours of task publication. The payment totaled $31.96. Of 812 radiology reports read, 384 (47%) were correctly interpreted by the patient surrogates. Patient surrogates had higher rates of comprehension of reports written in the patient summary (57%,  p  < 0.001) and traditional unstructured in combination with patient summary (51%,  p  = 0.004) formats than in the traditional unstructured format (40%). Most of the patient surrogates (114/203 [56%]) expressed a preference for receiving a full radiology report via an electronic patient portal. Several radiology colloquialisms with modifiers such as ""low,"" ""underdistended,"" and ""decompressed"" had low rates of comprehension.  CONCLUSION.  Use of the crowdsourcing platform is an expeditious, cost-effective, and customizable tool for surveying laypeople in sentiment- or task-based research. Patient summaries can help increase patient comprehension of radiology reports. Radiology colloquialisms are likely to be misunderstood by patients.",2020,"Use of the crowdsourcing platform is an expeditious, cost-effective, and customizable tool for surveying laypeople in sentiment- or task-based research.","['participants were surveyed as patient surrogates using a crowdsourcing platform', '203 participants enrolled for the first task and 1166 for the second within 48 hours of task publication']",[],['rates of comprehension of reports written'],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3494387', 'cui_str': 'Crowdsource'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0034036', 'cui_str': 'Publications'}]",[],"[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]",203.0,0.0752139,"Use of the crowdsourcing platform is an expeditious, cost-effective, and customizable tool for surveying laypeople in sentiment- or task-based research.","[{'ForeName': 'Joshua K', 'Initials': 'JK', 'LastName': 'Cho', 'Affiliation': 'Department of Radiology, Hospital of the University of Pennsylvania, 3400 Spruce St, 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Hanna M', 'Initials': 'HM', 'LastName': 'Zafar', 'Affiliation': 'Department of Radiology, Hospital of the University of Pennsylvania, 3400 Spruce St, 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Tessa S', 'Initials': 'TS', 'LastName': 'Cook', 'Affiliation': 'Department of Radiology, Hospital of the University of Pennsylvania, 3400 Spruce St, 1 Silverstein, Philadelphia, PA 19104.'}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22202']
1211,31086958,Plasma and tissue pharmacokinetics of fosfomycin in morbidly obese and non-obese surgical patients: a controlled clinical trial.,"OBJECTIVES


To assess the pharmacokinetics and tissue penetration of fosfomycin in obese and non-obese surgical patients.
METHODS


Fifteen obese patients undergoing bariatric surgery and 15 non-obese patients undergoing major intra-abdominal surgery received an intravenous single short infusion of 8 g of fosfomycin. Fosfomycin concentrations were determined by LC-MS/MS in plasma and microdialysate from subcutaneous tissue up to 8 h after dosing. The pharmacokinetic analysis was performed in plasma and interstitial fluid (ISF) by non-compartmental methods.
RESULTS


Thirteen obese patients (BMI 38-50 kg/m2) and 14 non-obese patients (BMI 0-29 kg/m2) were evaluable. The pharmacokinetics of fosfomycin in obese versus non-obese patients were characterized by lower peak plasma concentrations (468 ± 139 versus 594 ± 149 mg/L, P = 0.040) and higher V (24.4 ± 6.4 versus 19.0 ± 3.1 L, P = 0.010). The differences in AUC∞ were not significant (1275 ± 477 versus 1515 ± 352 mg·h/L, P = 0.16). The peak concentrations in subcutaneous tissue were reached rapidly and declined in parallel with the plasma concentrations. The drug exposure in tissue was nearly halved in obese compared with non-obese patients (AUC∞ 1052 ± 394 versus 1929 ± 725 mg·h/L, P = 0.0010). The tissue/plasma ratio (AUCISF/AUCplasma) was 0.86 ± 0.32 versus 1.27 ± 0.34 (P = 0.0047).
CONCLUSIONS


Whereas the pharmacokinetics of fosfomycin in plasma of surgical patients were only marginally different between obese and non-obese patients, the drug exposure in subcutaneous tissue was significantly lower in the obese patients.",2019,"The differences in AUC∞ were not significant (1275 ± 477 versus 1515 ± 352 mg·h/L, P = 0.16).","['Thirteen obese patients (BMI 38-50\u2009kg/m2) and 14 non-obese patients (BMI 0-29\u2009kg/m2) were evaluable', 'obese and non-obese surgical patients', 'obese versus non-obese patients', 'Fifteen obese patients undergoing bariatric surgery and 15 non-obese patients undergoing major intra-abdominal surgery received an', 'morbidly obese and non-obese surgical patients']",['intravenous single short infusion of 8\u2009g of fosfomycin'],"['Fosfomycin concentrations', 'peak plasma concentrations', 'tissue/plasma ratio (AUCISF/AUCplasma', 'peak concentrations in subcutaneous tissue', 'drug exposure in tissue', 'drug exposure in subcutaneous tissue', 'Plasma and tissue pharmacokinetics of fosfomycin']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}]","[{'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0278403', 'cui_str': 'Tela Subcutanea'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",15.0,0.0734296,"The differences in AUC∞ were not significant (1275 ± 477 versus 1515 ± 352 mg·h/L, P = 0.16).","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Dorn', 'Affiliation': 'Institute of Pharmacy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Petroff', 'Affiliation': 'Clinical Trial Centre, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Neumann', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kratzer', 'Affiliation': 'Hospital Pharmacy, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Nahed', 'Initials': 'N', 'LastName': 'El-Najjar', 'Affiliation': 'Institute of Clinical Microbiology and Hygiene, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Dietrich', 'Affiliation': 'Integrated Research and Treatment Center (IFB) Adiposity Diseases, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Kloft', 'Affiliation': 'Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Zeitlinger', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Kees', 'Affiliation': 'Department of Anaesthesiology, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Frieder', 'Initials': 'F', 'LastName': 'Kees', 'Affiliation': 'Department of Pharmacology, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Wrigge', 'Affiliation': 'Integrated Research and Treatment Center (IFB) Adiposity Diseases, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Integrated Research and Treatment Center (IFB) Adiposity Diseases, University of Leipzig, Leipzig, Germany.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz203']
1212,31106377,Non-lytic antibiotic treatment in community-acquired pneumococcal pneumonia does not attenuate inflammation: the PRISTINE trial.,"BACKGROUND


The inflammatory response in pneumococcal infection is primarily driven by immunoreactive bacterial cell wall components [lipoteichoic acid (LTA)]. An acute release of these components occurs when pneumococcal infection is treated with β-lactam antibiotics.
OBJECTIVES


We hypothesized that non-lytic rifampicin compared with lytic β-lactam antibiotic treatment would attenuate the inflammatory response in patients with pneumococcal pneumonia.
METHODS


In the PRISTINE (Pneumonia treated with RIfampicin aTtenuates INflammation) trial, a randomized, therapeutic controlled, exploratory study in patients with community-acquired pneumococcal pneumonia, we looked at LTA release and inflammatory and clinical response during treatment with both rifampicin and β-lactam compared with treatment with β-lactam antibiotics only. The trial is registered in the Dutch trial registry, number NTR3751 (European Clinical Trials Database number 2012-003067-22).
RESULTS


Forty-one patients with community-acquired pneumonia were included; 17 of them had pneumococcal pneumonia. LTA release, LTA-mediated inflammatory responses, clinical outcomes, inflammatory biomarkers and transcription profiles were not different between treatment groups.
CONCLUSIONS


The PRISTINE study demonstrated the feasibility of adding rifampicin to β-lactam antibiotics in the treatment of community-acquired pneumococcal pneumonia, but, despite solid in vitro and experimental animal research evidence, failed to demonstrate a difference in plasma LTA concentrations and subsequent inflammatory and clinical responses. Most likely, an inhibitory effect of human plasma contributes to the low immune response in these patients. In addition, LTA plasma concentration could be too low to mount a response via Toll-like receptor 2 in vitro, but may nonetheless have an effect in vivo.",2019,"LTA release, LTA-mediated inflammatory responses, clinical outcomes, inflammatory biomarkers and transcription profiles were not different between treatment groups.
","['community-acquired pneumococcal pneumonia', 'patients with pneumococcal pneumonia', 'Forty-one patients with community-acquired pneumonia were included; 17 of them had pneumococcal pneumonia', 'patients with community-acquired pneumococcal pneumonia']","['lytic β-lactam antibiotic treatment', 'rifampicin and β-lactam', 'rifampicin to β-lactam antibiotics', 'rifampicin', 'RIfampicin', 'β-lactam antibiotics only']","['LTA release, LTA-mediated inflammatory responses, clinical outcomes, inflammatory biomarkers and transcription profiles', 'inflammatory response']","[{'cui': 'C0456394', 'cui_str': 'Community acquired (qualifier value)'}, {'cui': 'C0155862', 'cui_str': 'Pneumonia, Pneumococcal'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439680', 'cui_str': 'Lytic (qualifier value)'}, {'cui': 'C0022914', 'cui_str': 'Lactams'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}]","[{'cui': 'C2729610', 'cui_str': 'LTA'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",41.0,0.234107,"LTA release, LTA-mediated inflammatory responses, clinical outcomes, inflammatory biomarkers and transcription profiles were not different between treatment groups.
","[{'ForeName': 'Geert H', 'Initials': 'GH', 'LastName': 'Groeneveld', 'Affiliation': 'Department of Internal Medicine and Infectious Diseases, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Tanny J', 'Initials': 'TJ', 'LastName': 'van der Reyden', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Simone A', 'Initials': 'SA', 'LastName': 'Joosten', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Hester J', 'Initials': 'HJ', 'LastName': 'Bootsma', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu, RIVM), Bilthoven, The Netherlands.'}, {'ForeName': 'Christa M', 'Initials': 'CM', 'LastName': 'Cobbaert', 'Affiliation': 'Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Jutte J C', 'Initials': 'JJC', 'LastName': 'de Vries', 'Affiliation': 'Department of Medical Microbiology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Ed J', 'Initials': 'EJ', 'LastName': 'Kuijper', 'Affiliation': 'Department of Medical Microbiology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Jaap T', 'Initials': 'JT', 'LastName': 'van Dissel', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz207']
1213,31106353,Four versus six weeks of antibiotic therapy for osteoarticular infections after implant removal: a randomized trial.,"BACKGROUND


The optimal duration of antibiotic therapy for treating orthopaedic implant infections after surgical drainage and complete implant removal is unknown.
METHODS


This was a single-centre, unblinded, prospective trial randomizing (1:1) eligible patients to either 4 or 6 weeks of systemic, pathogen-targeted antibiotic therapy. Clinical trial registration number: ClinicalTrials.gov (NCT0362209).
RESULTS


We analysed 123 eligible patients (62 in the 4 week antibiotic arm and 61 in the 6 week arm) in the ITT analysis. The patients' median age was 64 years, 75 (61%) were men and 38 (31%) were immunocompromised. The most common types of infection treated included: two-stage exchange procedure for prosthetic joint infection (n = 38); orthopaedic plate infection (44) and infected nail implants (11). The median duration of post-explant intravenous antibiotic therapy was 4 days. Overall, 120 episodes (98%) were cured microbiologically and 116 (94%) clinically after a median follow-up period of 2.2 years. During follow-up, four patients had a clinical recurrence with a pathogen other than the initial causative agent. We noted recurrence of clinical infection in four patients in the 4 week arm and three patients in the 6 week arm (4/62 versus 3/61; χ2 test; P = 0.74); in all cases, this occurred at around 2 months following the end of antibiotic treatment.
CONCLUSIONS


We found no statistically significant difference in the rates of clinical or microbiological remission between patients randomized to only 4 compared with 6 weeks of systemic antibiotic therapy after removal of an infected osteoarticular implant.",2019,We found no statistically significant difference in the rates of clinical or microbiological remission between patients randomized to only 4 compared with 6 weeks of systemic antibiotic therapy after removal of an infected osteoarticular implant.,"['123 eligible patients (62 in the 4\u2009week antibiotic arm and 61 in the 6\u2009week arm) in the ITT analysis', ""patients' median age was 64\u2009years, 75 (61%) were men and 38 (31%) were immunocompromised"", 'eligible patients to either 4 or 6\u2009weeks of systemic, pathogen-targeted antibiotic therapy', 'prosthetic joint infection (n\u205f=\u205f38); orthopaedic plate infection (44) and infected nail implants (11']","['antibiotic therapy', 'systemic antibiotic therapy']","['median duration', 'recurrence of clinical infection', 'rates of clinical or microbiological remission', 'clinical recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0410808', 'cui_str': 'Prosthetic joint infection (disorder)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0275521', 'cui_str': 'Clinical infection (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",123.0,0.238729,We found no statistically significant difference in the rates of clinical or microbiological remission between patients randomized to only 4 compared with 6 weeks of systemic antibiotic therapy after removal of an infected osteoarticular implant.,"[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Benkabouche', 'Affiliation': 'Department of Community Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Racloz', 'Affiliation': 'Orthopaedic Surgery Service, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Spechbach', 'Affiliation': 'Department of Community Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Lipsky', 'Affiliation': 'Service of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Gaspoz', 'Affiliation': 'Department of Community Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Uçkay', 'Affiliation': 'Orthopaedic Surgery Service, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz202']
1214,32068002,Effects of Elamipretide on Left Ventricular Function in Patients With Heart Failure With Reduced Ejection Fraction: The PROGRESS-HF Phase 2 Trial.,"BACKGROUND


Elamipretide, a novel mitochondrial modulating agent, improves myocardial energetics; however, it is unknown whether this mechanistic benefit translates into improved cardiac structure and function in heart failure (HF) with reduced ejection fraction (HFrEF). The objective of this study was to evaluate the effects of multiple subcutaneous doses of elamipretide on left ventricular end systolic volume (LVESV) as assessed by cardiac magnetic resonance imaging.
METHODS


We randomized 71 patients with HFrEF (LVEF ≤ 40%) in a double-blind, placebo-controlled trial in a 1:1:1 ratio to receive placebo, 4 mg or 40 mg elamipretide once daily for 28 consecutive days.
RESULTS


The mean age (standard deviation) of the study population was 65 ± 10 years, 24% were females, and the mean EF was 31% ± 7%. The change in LVESV from baseline to week 4 was not significantly different between elamipretide 4 mg (89.4 mL to 85 mL; difference, -4.4 mL) or 40 mg (77.9 mL to 76.6 mL; difference, -1.2 mL) compared with placebo (77.7 mL to 74.6 mL; difference, -3.8 mL) (4 mg vs placebo: difference of means, -0.3; 95% CI, -4.6 to 4.0; P  =  0.90; and 40 mg vs placebo: difference of means, 2.3; 95% CI, -1.9 to 6.5; P  =  0.28). Also, no significant differences in change in LVESV and LVEF were observed between placebo and either of the elamipretide groups. Rates of any study drug-related adverse events were similar in the 3 groups.
CONCLUSIONS


Elamipretide was well tolerated but did not improve LVESV at 4 weeks in patients with stable HFrEF compared with placebo.",2020,"CONCLUSIONS


Elamipretide was well tolerated but did not improve LVESV at 4 weeks in stable HFrEF patients compared with placebo.","['Mean age (SD) of the study population was 65±10 years, 24% were females, and mean EF was 31±7', 'Seventy-one', 'Patients with Heart Failure with Reduced Ejection Fraction']","['elamipretide', 'placebo', 'placebo, 4 mg or 40 mg elamipretide', 'cardiac magnetic resonance imaging (MRI', 'HFrEF (LVEF ≤ 40', 'Elamipretide']","['change in LVESV', 'adverse events', 'left ventricular end diastolic volume and left ventricular ejection fraction', 'left ventricular end systolic volume (LVESV', 'LVESV', 'Left Ventricular Function']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C4279623'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}]",,0.741968,"CONCLUSIONS


Elamipretide was well tolerated but did not improve LVESV at 4 weeks in stable HFrEF patients compared with placebo.","[{'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Missisippi, USA.'}, {'ForeName': 'Muhammad Shahzeb', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, Cook County Hospital, Chicago, Illinois, USA.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK), Berlin Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Kim', 'Affiliation': 'Duke Cardiovascular Magnetic Resonance Center, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Savina', 'Initials': 'S', 'LastName': 'Nodari', 'Affiliation': 'Cardiology Section, Department of Clinical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia, USA.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany; Department of Internal Medicine and Cardiology, German Heart Center Berlin, and German Centre for Cardiovascular Research (DZHK), Partner site Berlin, and Berlin Institute of Health (BIH), Berlin, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Pieske-Kraigher', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany; Department of Internal Medicine and Cardiology, German Heart Center Berlin, and German Centre for Cardiovascular Research (DZHK), Partner site Berlin, and Berlin Institute of Health (BIH), Berlin, Germany.'}, {'ForeName': 'Hani N', 'Initials': 'HN', 'LastName': 'Sabbah', 'Affiliation': 'Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiovascular Department, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Udelson', 'Affiliation': 'Division of Cardiology and the Cardiovascular Center, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Carr', 'Affiliation': 'Stealth BioTherapeutics, Newton, Massachusetts, USA.'}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Gheorghiade', 'Affiliation': 'Department of Medicine, Bluhm Cardiovascular Institute, Northwestern University Feingerg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece. Electronic address: geros@otenet.gr.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.02.001']
1215,31255395,"Cocaine enhances figural, but impairs verbal 'flexible' divergent thinking.","Anecdotal evidence suggests that cocaine use will help overcome creative 'blocks' by enhancing flexible thinking. Given that cocaine is likely to enhance dopamine (DA) levels, which in turn are positively associated with divergent thinking (DT); is a possibility that is tested in the present study. Furthermore, the impact of cocaine is tested on convergent thinking (CT), another aspect of creative thinking, which has been reported to be impaired with high DA levels. It was hypothesized that cocaine would enhance DT and impair CT. A placebo-controlled within-subjects study including 24 healthy poly-drug users was set up to test the influence of oral cocaine (300 mg) on creativity. Verbal CT was assessed with the Remote Associates Task (RAT); figural CT was assessed with the Picture Concepts Task (PCT) and the Tower of London (TOL). Verbal DT was assessed with the Alternative Uses Task (AUT); figural DT was assessed with the Pattern/Line Meanings Task (PLMT). Findings showed that, compared to placebo, cocaine impaired figural CT (TOL) and flexible DT of verbal stimuli (AUT), while it enhanced figural DT (PLMT). No significant effects of cocaine were observed regarding the PCT and RAT. It was demonstrated that cocaine-induced effects on creativity in poly-drug users are stimulus-dependent. Cocaine enhanced performance on figural DT but impaired performance on verbal (flexible) DT. Cocaine impaired CT on only one figural task and but not on the other tasks. As creativity is an important aspect in cognitive therapies, it is important to further understand these discrepancies in creativity task performance.",2019,"Findings showed that, compared to placebo, cocaine impaired figural CT (TOL) and flexible DT of verbal stimuli (AUT), while it enhanced figural DT (PLMT).",['24 healthy poly-drug users'],"['placebo', 'cocaine', 'oral cocaine', 'Cocaine impaired CT', 'placebo, cocaine', 'Cocaine']","['enhanced figural DT (PLMT', 'figural CT (TOL) and flexible DT of verbal stimuli (AUT', 'Verbal DT', 'enhance DT and impair CT', 'Verbal CT', 'dopamine (DA) levels']","[{'cui': 'C0338666', 'cui_str': 'Drug Users'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",24.0,0.0213043,"Findings showed that, compared to placebo, cocaine impaired figural CT (TOL) and flexible DT of verbal stimuli (AUT), while it enhanced figural DT (PLMT).","[{'ForeName': 'Nadia R P W', 'Initials': 'NRPW', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands. Electronic address: nadia.hutten@maastrichtuniversity.nl.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Steenbergen', 'Affiliation': 'Institute for Psychological Research and Leiden Institute for Brain and Cognition, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Lorenza S', 'Initials': 'LS', 'LastName': 'Colzato', 'Affiliation': 'Institute for Psychological Research and Leiden Institute for Brain and Cognition, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Hommel', 'Affiliation': 'Institute for Psychological Research and Leiden Institute for Brain and Cognition, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Eef L', 'Initials': 'EL', 'LastName': 'Theunissen', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Kim P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, Maastricht, the Netherlands.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.06.003']
1216,31310994,Estimated Physical Activity in Adolescents by Wrist-Worn GENEActiv Accelerometers.,"BACKGROUND


Reports of physical activity (PA) measured via wrist-worn accelerometers in adolescents are limited. This study describes PA levels in adolescents at baseline of an obesity prevention and weight management trial.
METHODS


Adolescents (n = 930) at 8 high schools wore an accelerometer for 7 days, with average acceleration values of <50 mg, >150 mg, and >500 mg categorized as sedentary, moderate, and vigorous PA, respectively. In a 3-level mixed-effects generalized linear model, PA was regressed on sex, weight status, and day of week. Daily PA was nested within students, and students within schools, with random effects included for both.
RESULTS


Adolescents accumulated a median of 40 minutes daily of moderate to vigorous PA (MVPA). MVPA was significantly different for teens with obesity versus teens with normal weight (-5.4 min/d, P = .03); boys versus girls (16.3 min/d, P < .001); and Sundays versus midweek (-16.6 min/d, P < .001). Average sedentary time increased on weekends (Saturday: 19.1 min/d, P < .001; Sunday: 44.8 min, P < .001) relative to midweek but did not differ by sex or weight status.
CONCLUSIONS


Interventions to increase PA in adolescents may benefit from focusing on increasing weekend PA and increasing MVPA in girls.",2019,"Average sedentary time increased on weekends (Saturday: 19.1 min/d, P < .001; Sunday: 44.8 min, P < .001) relative to midweek but did not differ by sex or weight status.
","['Adolescents (n = 930) at 8 high schools wore an accelerometer for 7 days, with average acceleration values of <50\xa0mg, >150\xa0mg, and >500\xa0mg categorized as sedentary, moderate, and vigorous PA, respectively', 'adolescents at baseline of an obesity prevention and weight management trial', 'teens with obesity versus teens with normal weight (-5.4\xa0min']",['MVPA'],"['median of 40 minutes daily of moderate to vigorous PA (MVPA', 'Average sedentary time', 'Estimated Physical Activity']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",930.0,0.041892,"Average sedentary time increased on weekends (Saturday: 19.1 min/d, P < .001; Sunday: 44.8 min, P < .001) relative to midweek but did not differ by sex or weight status.
","[{'ForeName': 'Sarah G', 'Initials': 'SG', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'Elizabeth Yakes', 'Initials': 'EY', 'LastName': 'Jimenez', 'Affiliation': ''}, {'ForeName': 'Natalie H', 'Initials': 'NH', 'LastName': 'Cole', 'Affiliation': ''}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Kuhlemeier', 'Affiliation': ''}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'McCauley', 'Affiliation': ''}, {'ForeName': 'M Lee', 'Initials': 'ML', 'LastName': 'Van Horn', 'Affiliation': ''}, {'ForeName': 'Alberta S', 'Initials': 'AS', 'LastName': 'Kong', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0344']
1217,31314045,Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are used in clinical practice. Nevertheless, comparative prognostic outcomes of iFR-guided and FFR-guided treatment in patients with type 2 diabetes have not yet been fully investigated.
Objective


To compare 1-year clinical outcomes of iFR-guided or FFR-guided treatment in patients with and without diabetes in the Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization (DEFINE-FLAIR) trial.
Design, Setting, and Participants


The DEFINE-FLAIR trial is a multicenter, international, randomized, double-blinded trial that randomly assigned 2492 patients in a 1:1 ratio to undergo either iFR-guided or FFR-guided coronary revascularization. Patients were eligible for trial inclusion if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery. Data were analyzed between January 2014 and December 2015.
Interventions


According to the study protocol, iFR of 0.89 or less and FFR of 0.80 or less were used as criteria for revascularization. When iFR or FFR was higher than the prespecified threshold, revascularization was deferred.
Main Outcomes and Measures


The primary end point was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. The incidence of MACE was compared according to the presence of diabetes in iFR-guided and FFR-guided groups.
Results


Among the total trial population (2492 patients), 758 patients (30.4%) had diabetes. Mean age of the patients was 66 years, 76% were men (1868 of 2465), and 80% of patients presented with stable angina (1983 of 2465). In the nondiabetes population (68.5%; 1707 patients), iFR guidance was associated with a significantly higher rate of deferral of revascularization than the FFR-guided group (56.5% [n = 477 of 844] vs 46.6% [n = 402 of 863]; P < .001). However, it was not different between the 2 groups in the diabetes population (42.1% [n = 161 of 382] vs 47.1% [n = 177 of 376]; P = .15). At 1 year, the diabetes population showed a significantly higher rate of MACE than the nondiabetes population (8.6% vs 5.6%; adjusted hazard ratio [HR], 1.88; 95% CI, 1.28-2.64; P < .001). However, there was no significant difference in MACE rates between iFR-guided and FFR-guided groups in both the diabetes (10.0% vs 7.2%; adjusted HR, 1.33; 95% CI, 0.78-2.25; P = .30) and nondiabetes population (4.7% vs 6.4%; HR, 0.83; 95% CI, 0.51-1.35; P = .45) (interaction P = .25).
Conclusions and Relevance


The diabetes population showed significantly higher risk of MACE than the nondiabetes population, even with the iFR-guided or FFR-guided treatment. The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes.
Trial Registration


ClinicalTrials.gov identifier: NCT02053038.",2019,"The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes.
","['patients with and without diabetes in the Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization (DEFINE-FLAIR) trial', 'total trial population (2492 patients), 758 patients (30.4%) had diabetes', '2492 patients in a 1:1 ratio to undergo either', 'Mean age of the patients was 66 years, 76% were men (1868 of 2465), and 80% of patients presented with stable angina (1983 of 2465', 'Patients With or Without Type 2 Diabetes', 'Patients were eligible for trial inclusion if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery', 'patients with type 2 diabetes', 'patients with diabetes']","['iFR-guided or FFR-guided treatment', 'iFR-guided or FFR-guided coronary revascularization', 'iFR-guided and FFR-guided treatment']","['rate of deferral of revascularization', 'iFR guidance', 'rate of MACE', 'fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR', 'MACE rates', 'major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",2492.0,0.0609224,"The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Joo Myung', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ki Hong', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Bon-Kwon', 'Initials': 'BK', 'LastName': 'Koo', 'Affiliation': 'Seoul National University Hospital and Institute on Aging, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Hakim-Moulay', 'Initials': 'HM', 'LastName': 'Dehbi', 'Affiliation': 'Cancer Research UK and University College London Cancer Trials Centre, University College London, London, England.'}, {'ForeName': 'Joon-Hyung', 'Initials': 'JH', 'LastName': 'Doh', 'Affiliation': 'Inje University Ilsan Paik Hospital, Daehwa-Dong, South Korea.'}, {'ForeName': 'Chang-Wook', 'Initials': 'CW', 'LastName': 'Nam', 'Affiliation': 'Keimyung University Dongsan Medical Center, Daegu, South Korea.'}, {'ForeName': 'Eun-Seok', 'Initials': 'ES', 'LastName': 'Shin', 'Affiliation': 'Ulsan Hospital, Ulsan, South Korea and Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cook', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Al-Lamee', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Petraco', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Sayan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Iqbal S', 'Initials': 'IS', 'LastName': 'Malik', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Sukhjinder S', 'Initials': 'SS', 'LastName': 'Nijjer', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Hernán', 'Initials': 'H', 'LastName': 'Mejía-Rentería', 'Affiliation': 'Hospital Clínico San Carlos, IDISSC and Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Alegria-Barrero', 'Affiliation': 'Hospital Universitario de Torrejón, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alghamdi', 'Affiliation': 'King Abdulaziz Medical City Cardiac Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Altman', 'Affiliation': 'Colorado Heart and Vascular, Lakewood, Colorado.'}, {'ForeName': 'Sérgio B', 'Initials': 'SB', 'LastName': 'Baptista', 'Affiliation': 'Hospital Prof Doutor Fernando Fonseca, Amadora, Portugal.'}, {'ForeName': 'Ravinay', 'Initials': 'R', 'LastName': 'Bhindi', 'Affiliation': 'Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Bojara', 'Affiliation': 'Gemeinschaftsklinikum Mittelrhein, Kemperhof Koblenz, Koblenz, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Pedro Canas', 'Initials': 'PC', 'LastName': 'Silva', 'Affiliation': 'Hospital Santa Maria, Lisbon, Portugal.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Mario', 'Affiliation': 'Royal Brompton Hospital, Imperial College London, London, England.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'Pauls Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Gerber', 'Affiliation': 'Conquest Hospital, St Leonards-on-Sea, England.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Going', 'Affiliation': 'Sana Klinikum Lichtenberg, Lichtenberg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Härle', 'Affiliation': 'Klinikum Oldenburg, European Medical School, Carl von Ossietzky University, Oldenburg, Germany.'}, {'ForeName': 'Farrel', 'Initials': 'F', 'LastName': 'Hellig', 'Affiliation': 'Sunninghill Hospital, Johannesburg, South Africa.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Indolfi', 'Affiliation': 'University Magna Graecia, Catanzaro, Italy.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Imelda Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Jeremias', 'Affiliation': 'Stony Brook University Medical Center, New York, New York.'}, {'ForeName': 'Rajesh K', 'Initials': 'RK', 'LastName': 'Kharbanda', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust, Oxford, England.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Khashaba', 'Affiliation': 'Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Yuetsu', 'Initials': 'Y', 'LastName': 'Kikuta', 'Affiliation': 'Fukuyama Cardiovascular Hospital, Fukuyama, Japan.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krackhardt', 'Affiliation': 'Charite Campus Virchow Klinikum, Universitaetsmedizin, Berlin, Germany.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Lehman', 'Affiliation': 'Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Matsuo', 'Affiliation': 'Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Martijin', 'Initials': 'M', 'LastName': 'Meuwissen', 'Affiliation': 'Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Niccoli', 'Affiliation': 'Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'AMC Heart Center, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Flavo', 'Initials': 'F', 'LastName': 'Ribichini', 'Affiliation': 'University Hospital Verona, Verona, Italy.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Samady', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sapontis', 'Affiliation': 'Monash Heart, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Arnold H', 'Initials': 'AH', 'LastName': 'Seto', 'Affiliation': 'Veterans Affairs Long Beach Healthcare System, Long Beach, California.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Sezer', 'Affiliation': 'Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Andrew S P', 'Initials': 'ASP', 'LastName': 'Sharp', 'Affiliation': 'Royal Devon and Exeter Hospital, Exeter, England.'}, {'ForeName': 'Jasvindar', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Takashima', 'Affiliation': 'Aichi Medical University Hospital, Aichi, Japan.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Talwar', 'Affiliation': 'Royal Bournemouth General Hospital, Bournemouth, England.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kare', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Essex Cardiothoracic Centre, Basildon, England.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Belle', 'Affiliation': 'Institut Coeur Poumon, Lille University Hospital, Lille, France.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Vinhas', 'Affiliation': 'Hospital Garcia de Horta, Lisbon, Portugal.'}, {'ForeName': 'Christiaan J', 'Initials': 'CJ', 'LastName': 'Vrints', 'Affiliation': 'Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Walters', 'Affiliation': 'Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Yokoi', 'Affiliation': 'Fukuoka Sannou Hospital, Fukuoka, Japan.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Samuels', 'Affiliation': 'Cedars-Sinai Heart Institute, Los Angeles, California.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Buller', 'Affiliation': 'St Michaels Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Serruys', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos, IDISSC and Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2298']
1218,31301476,Self-guided internet-delivered cognitive behavior therapy (ICBT) for obsessive-compulsive symptoms: A randomized controlled trial.,"Internet-delivered cognitive behavior therapy (ICBT) for obsessive-compulsive disorder (OCD) has been demonstrated to be efficacious across multiple clinical trials. However, most of these interventions include clinician support, and many individuals with OCD prefer to manage their own symptoms. Self-guided ICBT overcomes this problem, but to date the efficacy of self-guided interventions has only been studied in uncontrolled trials. The present study aims to examine the efficacy and acceptability of ICBT for OCD symptoms when delivered in a self-guided format using a randomized controlled trial design. In the present study, 190 participants were randomized to either a self-guided ICBT condition or a waitlist control group. 140 participants completed the baseline assessment, initiated treatment, and were included in the analyses. The between-group effect size at post-treatment was large on the self-report version of the Yale-Brown Obsessive-Compulsive Scale (d = 1.05; 95% CI 0.89-1.21). Twenty-seven percent of the ICBT condition met conservative criteria for clinically significant change at post-treatment, which increased to thirty-eight percent at three-month follow-up. Participants rated the program as highly acceptable. The results indicate that self-guided ICBT may be a viable treatment option for some individuals with OCD symptoms.",2019,The between-group effect size at post-treatment was large on the self-report version of the Yale-Brown Obsessive-Compulsive Scale (d = 1.05; 95% CI 0.89-1.21).,"['obsessive-compulsive disorder (OCD', '140 participants completed the baseline assessment, initiated treatment, and were included in the analyses', 'obsessive-compulsive symptoms', '190 participants']","['self-guided ICBT condition or a waitlist control group', 'Internet-delivered cognitive behavior therapy (ICBT', 'ICBT', 'Self-guided internet-delivered cognitive behavior therapy (ICBT']","['self-report version of the Yale-Brown Obsessive-Compulsive Scale', 'efficacy and acceptability']","[{'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",190.0,0.0554015,The between-group effect size at post-treatment was large on the self-report version of the Yale-Brown Obsessive-Compulsive Scale (d = 1.05; 95% CI 0.89-1.21).,"[{'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Wootton', 'Affiliation': 'University of Technology Sydney, NSW, Australia; Macquarie University, Sydney, NSW, Australia. Electronic address: bethany.wootton@uts.edu.au.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Karin', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Titov', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Blake F', 'Initials': 'BF', 'LastName': 'Dear', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102111']
1219,30861262,The effect of increased frequency of hemodialysis on serum cystatin C and β2-microglobulin concentrations: A secondary analysis of the frequent hemodialysis network (FHN) trial.,"INTRODUCTION


Small molecular weight toxin clearance is the main method of assessment of hemodialysis efficiency. Middle molecules including cystatin C (CysC) and Beta-2 microglobulin (β2-M) are understudied. We hypothesized that lowering of predialysis CysC and β2-M serum concentrations would be affected by switching to more frequent hemodialysis.
METHODS


Predialysis CysC and β2-M serum concentrations were measured from serum samples of the Frequent Hemodialysis Network (FHN) Daily and Nocturnal Trials. The differences between predialysis concentrations at baseline (while on conventional thrice weekly dialysis) and those after 12-months of study (on more frequent dialysis) were compared separately by trial (Nocturnal, Daily). We tested the associations between predialysis serum CysC and β2-M concentrations and outcomes.
FINDINGS


Forty-nine percent and 52% of the patients from the FHN Daily and Nocturnal Trials respectively were included in this ancillary study. Predialysis serum CysC concentrations remained unchanged after intensifying hemodialysis dose by either modality. There was significant lowering of the serum β2-M concentrations in the frequent Daily Trial hemodialysis group at 12 months in all patients and in patients without residual renal function at baseline (-3.8 ± 12.62 μg/mL, P = 0.004; -5.9 ± 12.99 μg/mL, P = 0.02, respectively). There were no significant differences between the baseline and the 12-months predialysis β2-M serum concentrations in the two control groups (Daily 3× and Nocturnal 3× groups). No association between the changes in the two biomarkers between baseline and 12-months and in changes in left ventricular mass, physical-health composite scores, hospitalization rate, and death were found. The numbers of hospitalizations and deaths were small.
DISCUSSION


β2-M may be a better biomarker of dialysis dose than CysC. Reduction in the concentration of potentially toxic long-lived proteins of the size of β-2M is one potential long-term benefit of more intensive dialysis that may be explored.",2019,"There was significant lowering of the serum β2-M concentrations in the frequent Daily Trial hemodialysis group at 12 months in all patients and in patients without residual renal function at baseline (-3.8 ± 12.62 μg/mL, P = 0.004; -5.9 ± 12.99 μg/mL, P = 0.02, respectively).",['Forty-nine percent and 52% of the patients from the FHN Daily and Nocturnal Trials respectively were included in this ancillary study'],[],"['12-months predialysis β2-M serum concentrations', 'left ventricular mass, physical-health composite scores, hospitalization rate, and death', 'serum β2-M concentrations', 'numbers of hospitalizations and deaths', 'cystatin C (CysC) and Beta-2 microglobulin (β2-M', 'predialysis serum CysC and β2-M concentrations and outcomes', 'predialysis concentrations', 'predialysis CysC and β2-M serum concentrations', 'Predialysis serum CysC concentrations', 'residual renal function', 'β2-M serum concentrations']","[{'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0201910', 'cui_str': 'Beta-2-microglobulin measurement (procedure)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",,0.0653657,"There was significant lowering of the serum β2-M concentrations in the frequent Daily Trial hemodialysis group at 12 months in all patients and in patients without residual renal function at baseline (-3.8 ± 12.62 μg/mL, P = 0.004; -5.9 ± 12.99 μg/mL, P = 0.02, respectively).","[{'ForeName': 'Shih-Han S', 'Initials': 'SS', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, Division of Nephrology, Western University, London, Canada.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Kaysen', 'Affiliation': 'Department of Medicine, Division of Nephrology and Department of Biochemistry and Molecular Medicine, University of California Davis School of Medicine, Davis, California, USA.'}, {'ForeName': 'Nathan W', 'Initials': 'NW', 'LastName': 'Levin', 'Affiliation': 'Mount Sinai Icahn School of Medicine, New York City, New York, USA.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Kliger', 'Affiliation': 'School of Medicine, and Yale New Haven Health System, New Haven, Connecticut, USA.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Beck', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Department of Medicine, Section on Nephrology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Filler', 'Affiliation': 'Department of Medicine, Division of Nephrology, Western University, London, Canada.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Lindsay', 'Affiliation': 'Department of Medicine, Division of Nephrology, Western University, London, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12749']
1220,31300288,"Persistence of immunity to conjugate and polysaccharide pneumococcal vaccines in frail, hospitalised older adults in long-term follow up.","BACKGROUND


Data on long-term antibody responses to pneumococcal vaccines in the elderly, especially the frail elderly at greatest risk of severe disease, are limited. We followed up participants in a randomised trial of the immunogenicity of 23-valent polysaccharide vaccine (23vPPV) and 7 valent pneumococcal conjugate vaccines (PCV7) in hospitalised older adults.
METHODS


We measured antibody to vaccine serotypes by standardised enzyme-linked immunosorbent assay (ELISA) and opsonophagocytic (OPA) assays. A follow up study was conducted six years after vaccination with 23vPPV alone or with PCV7 followed by 23vPPV six months later.
RESULTS


Of 215 surviving trial participants, 136 (63%) completed follow up; 62 received 23vPPV and 74 received PCV7 + 23vPPV. There was no significant difference in death and readmission between arms. Antibody levels by ELISA and OPA did not differ significantly between the two study arms at 72 months post-vaccination. ELISA and OPA antibody remained higher than baseline except for OPA antibody to 4, 6A, 6B, 9v, 19F and 23F, including in subjects with undetectable immunity at baseline.
DISCUSSION


While ELISA responses in both study arms remained high 6 years post-vaccination, considerable waning was observed by OPA in both study arms, which should be considered given the current single-dose recommendation in Australia. Further research is needed to inform pneumococcal vaccine recommendations in people over the age of 65.",2019,"ELISA and OPA antibody remained higher than baseline except for OPA antibody to 4, 6A, 6B, 9v, 19F and 23F, including in subjects with undetectable immunity at baseline.
","['people over the age of 65', 'Of 215 surviving trial participants, 136 (63%) completed follow up', 'hospitalised older adults', 'frail, hospitalised older adults']","['23vPPV', 'PCV7\u202f+\u202f23vPPV', '23vPPV alone or with PCV7', 'polysaccharide pneumococcal vaccines', '23-valent polysaccharide vaccine (23vPPV) and 7 valent pneumococcal conjugate vaccines (PCV7']","['ELISA and OPA antibody', 'Antibody levels by ELISA and OPA', 'death and readmission']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine (substance)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}]","[{'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0561056,"ELISA and OPA antibody remained higher than baseline except for OPA antibody to 4, 6A, 6B, 9v, 19F and 23F, including in subjects with undetectable immunity at baseline.
","[{'ForeName': 'C Raina', 'Initials': 'CR', 'LastName': 'MacIntyre', 'Affiliation': 'Biosecurity Program, Kirby Institute, Faculty of Medicine, University of New South Wales, Sydney, Australia. Electronic address: r.macintyre@unsw.edu.au.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Ridda', 'Affiliation': 'Independent Scholar, Sydney, Australia.'}, {'ForeName': 'Mallory J', 'Initials': 'MJ', 'LastName': 'Trent', 'Affiliation': 'Biosecurity Program, Kirby Institute, Faculty of Medicine, University of New South Wales, Sydney, Australia. Electronic address: mallory.trent@unsw.edu.au.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McIntyre', 'Affiliation': 'National Centre for Immunisation Research and Surveillance, University of Sydney, Sydney, Australia. Electronic address: peter.mcintyre@sydney.edu.au.'}]",Vaccine,['10.1016/j.vaccine.2019.07.005']
1221,31296289,Edoxaban Versus Warfarin in Patients With Atrial Fibrillation and History of Liver Disease.,"BACKGROUND


Patients with liver disease have increased risk of thrombosis and bleeding but are typically excluded from trials of direct oral anticoagulant agents.
OBJECTIVES


This study evaluated the pharmacokinetics (PK), pharmacodynamics (PD), clinical efficacy and safety of edoxaban versus warfarin in patients with atrial fibrillation (AF) and history of liver disease.
METHODS


ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction Study 48) was a randomized, double-blind trial comparing edoxaban with warfarin in patients with AF followed for 2.8 years. History of liver disease was defined as investigator-reported liver disease or >2-fold transaminase elevation at randomization. The primary efficacy and safety endpoints of stroke or systemic embolic event (SSEE) and major bleeding were assessed stratified by history of liver disease. PK/PD assessments of edoxaban included endogenous and extrinsic factor Xa activity and edoxaban concentration.
RESULTS


Among 21,105 patients, 1,083 (5.1%) had a history of liver disease; they had a higher prevalence of many comorbidities. The adjusted risks of SSEE were similar (adjusted hazard ratio [HR adj ]: 0.90; 95% confidence interval [CI]: 0.67 to 1.22; p = 0.50), but major bleeding was more common in patients with liver disease (HR adj : 1.38; 95% CI: 1.10 to 1.74; p = 0.005). There were no significant differences in PK/PD assessment of edoxaban in patients with versus without liver disease. The HRs for higher-dose edoxaban versus warfarin for SSEE were 0.86 (95% CI: 0.73 to 1.01) in patients without and 1.11 (95% CI: 0.54 to 2.30) with liver disease (p for interaction [p int ] = 0.47), major bleeding 0.80 (95% CI: 0.70 to 0.91) in patients without and 0.91 (95% CI: 0.56 to 1.47) with liver disease (p int  = 0.63). There were no significant differences in hepatic adverse events between the 2 treatment groups.
CONCLUSIONS


Among patients with AF receiving oral anticoagulation, bleeding, but not thromboembolic events, was increased in patients with liver disease. A history of liver disease did not alter the relative efficacy and safety of edoxaban compared with warfarin. Hepatic adverse events were similar between edoxaban and warfarin.",2019,"Among patients with AF receiving oral anticoagulation, bleeding, but not thromboembolic events, was increased in patients with liver disease.","['ENGAGE AF-TIMI 48', 'Patients\xa0With Atrial Fibrillation and History of Liver Disease', '21,105 patients, 1,083 (5.1%) had a history of liver disease', 'patients with AF receiving oral anticoagulation, bleeding', 'Patients with liver disease', 'Atrial Fibrillation-Thrombolysis', 'patients with AF followed for 2.8 years', 'patients with atrial fibrillation (AF) and history of liver disease', 'patients with versus without liver disease']","['edoxaban', 'edoxaban with warfarin', 'warfarin', 'edoxaban and warfarin', 'Factor', 'edoxaban versus warfarin', 'Edoxaban Versus Warfarin']","['Hepatic adverse events', 'major bleeding', 'pharmacokinetics (PK), pharmacodynamics (PD), clinical efficacy and safety', 'PK/PD assessment', 'stroke or systemic embolic event (SSEE) and major bleeding', 'adjusted risks of SSEE', 'thromboembolic events', 'hepatic adverse events', 'endogenous and extrinsic factor Xa activity and edoxaban concentration', 'History of liver disease']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0455550', 'cui_str': 'H/O: liver disease'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0595947', 'cui_str': 'Extrinsic (qualifier value)'}, {'cui': 'C0015520', 'cui_str': 'Factor 10A'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0455550', 'cui_str': 'H/O: liver disease'}]",,0.137387,"Among patients with AF receiving oral anticoagulation, bleeding, but not thromboembolic events, was increased in patients with liver disease.","[{'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Qamar', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/AqamarMD.""}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/eantman.""}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Nordio', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Laura T', 'Initials': 'LT', 'LastName': 'Grip', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Norton J', 'Initials': 'NJ', 'LastName': 'Greenberger', 'Affiliation': ""Gastroenterology, Hepatology, and Endoscopy Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ophelia Q P', 'Initials': 'OQP', 'LastName': 'Yin', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, New Jersey.'}, {'ForeName': 'Youngsook', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, New Jersey.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Lanz', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, New Jersey.'}, {'ForeName': 'Michele F', 'Initials': 'MF', 'LastName': 'Mercuri', 'Affiliation': 'Daiichi-Sankyo, Munich, Germany.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: rgiugliano@partners.org.""}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.04.061']
1222,31296293,Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: The DRASTICO Study.,"BACKGROUND


Drug-eluting technologies improve 12-month angiographic results of femoropopliteal (FP) interventions, but few data on the comparison between drug-coated balloons (DCBs) and drug-eluting stents (DES) are available.
OBJECTIVES


The aim of this study was to compare, after balloon pre-dilation, a strategy of DCB followed by provisional self-expanding nitinol bare-metal stent implantation with a strategy of systematic DES implantation in patients at high risk for FP restenosis.
METHODS


Patients presenting with either intermittent claudication or critical limb ischemia undergoing FP intervention were randomly assigned 1:1 to DCB or DES after successful target lesion pre-dilation. The primary endpoint was 12-month target lesion binary restenosis, assessed using Doppler ultrasound. Secondary endpoints were freedom from target lesion revascularization and from major amputation.
RESULTS


A total of 192 patients, 96 in the DCB group and 96 in the DES group, with 240 lesions in 225 limbs, were included. Diabetes and critical limb ischemia were present in >50% in both groups. Mean lesion length was 14 cm, and baseline target lesion occlusion reached about 60% of cases in both groups. The systematic DES strategy yielded larger post-procedural minimal luminal diameter and a lower incidence of residual dissection compared to DCB, in which nitinol stents were used in only 21% of the lesions. Twelve-month target lesion restenosis was observed in 22% of DCB-treated versus 21% of DES-treated patients (p = 0.90). Clinically driven target lesion revascularization was necessary in 14% of DCB patients versus 17% of DES patients (p = 0.50).
CONCLUSIONS


DCB was not superior to DES in the treatment of complex FP lesions in a high-risk population, yielding similar rate of restenosis and clinically driven target lesion revascularization. (Paclitaxel-Eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-Eluting Stent for the Treatment of Femoropopliteal De Novo Lesions; NCT01969630).",2019,"The systematic DES strategy yielded larger post-procedural minimal luminal diameter and a lower incidence of residual dissection compared to DCB, in which nitinol stents were used in only 21% of the lesions.","['192 patients, 96 in the DCB group and 96 in the DES group, with 240 lesions in 225 limbs, were included', 'Patients presenting with either intermittent claudication or critical limb ischemia undergoing FP intervention', 'Femoropopliteal Arterial Lesions', 'patients at high risk for FP restenosis']","['Paclitaxel-Eluting Balloon Angioplasty', 'Drug-Eluting Balloon Versus Drug-Eluting\xa0Stent for Complex', 'DCB or DES', 'Paclitaxel-Eluting Stent', 'systematic DES implantation', 'DCB followed by provisional self-expanding nitinol bare-metal stent implantation', 'DES']","['freedom from target lesion revascularization and from major amputation', 'baseline target lesion occlusion', 'lesion restenosis', 'Diabetes and critical limb ischemia', '12-month target lesion binary restenosis, assessed using Doppler ultrasound', 'Mean lesion length']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0068790', 'cui_str': 'nickel titanium'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent (physical object)'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",192.0,0.0638307,"The systematic DES strategy yielded larger post-procedural minimal luminal diameter and a lower incidence of residual dissection compared to DCB, in which nitinol stents were used in only 21% of the lesions.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Liistro', 'Affiliation': 'Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy. Electronic address: francescoliistro@hotmail.com.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Angioli', 'Affiliation': 'Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Italo', 'Initials': 'I', 'LastName': 'Porto', 'Affiliation': 'Cardiovascular Unit, Policlinico San Martino IRCCS, Università di Genova, Genoa, Italy.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ducci', 'Affiliation': 'Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Falsini', 'Affiliation': 'Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Ventoruzzo', 'Affiliation': 'Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Ricci', 'Affiliation': 'Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Scatena', 'Affiliation': 'Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Grotti', 'Affiliation': 'Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bolognese', 'Affiliation': 'Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.04.057']
1223,30753662,Impact of a novel oral health promotion program on routine oral hygiene among socioeconomically disadvantaged smokers: results from a randomized semi-pragmatic trial.,"Smokers are at high risk of oral disease and report sub-optimal oral hygiene. Improving smokers' oral hygiene could reduce their future disease risk. The purpose of this study is to assess the effects of a novel, multi-modal oral health promotion program (Oral Health 4 Life; OH4L) targeted to socioeconomically disadvantaged smokers and delivered through state-funded tobacco quitlines. Smokers (n = 718) were randomized to standard quitline care or standard care plus OH4L. OH4L recipients received a comprehensive behavioral intervention and were advised of the benefits of routine oral hygiene, encouraged to brush and floss daily (for better oral health and to manage cigarette cravings), and provided a toothbrush and floss. Participants were followed for 6 months to assess the intervention effects on routine oral hygiene (brushing and flossing) and changes in motivation and self-efficacy. Data were collected between 2015 and 2017. At 2-month follow-up, OH4L participants were more likely to meet the American Dental Association (ADA) recommendations for brushing twice daily (adjusted RR = 1.15 [1.04, 1.27], p = .006), flossing daily (adjusted RR = 1.20 [1.03, 1.39], p = .02), and for both brushing and flossing (adjusted RR = 1.33 [1.10, 1.61], p = .003). Daily flossing was more likely at 6-month follow-up (adjusted RR = 1.21 [1.04, 1.42], p = .02) among OH4L participants. The change in self-efficacy and motivation for daily flossing from baseline to 2 months was significantly greater among OH4L participants and mediated the intervention effect on flossing at 6 months. Integrating oral hygiene promotion with standard tobacco quitline services improved oral health self-care.",2020,The change in self-efficacy and motivation for daily flossing from baseline to 2 months was significantly greater among OH4L participants and mediated the intervention effect on flossing at 6 months.,"['socioeconomically disadvantaged smokers', 'Smokers (n = 718', 'socioeconomically disadvantaged smokers and delivered through state-funded tobacco quitlines']","['novel, multi-modal oral health promotion program (Oral Health 4 Life; OH4L', 'standard tobacco quitline services', 'novel oral health promotion program', 'standard quitline care or standard care plus OH4L. OH4L recipients received a comprehensive behavioral intervention']","['oral health self-care', 'routine oral hygiene (brushing and flossing) and changes in motivation and self-efficacy', 'self-efficacy and motivation for daily flossing', 'American Dental Association (ADA) recommendations', 'routine oral hygiene']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0150290', 'cui_str': 'Oral health promotion (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0029162'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0029162'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0002456', 'cui_str': 'American Dental Association'}]",718.0,0.0379281,The change in self-efficacy and motivation for daily flossing from baseline to 2 months was significantly greater among OH4L participants and mediated the intervention effect on flossing at 6 months.,"[{'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'McClure', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute (formerly, Group Health Research Institute), Seattle, WA, USA.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Anderson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute (formerly, Group Health Research Institute), Seattle, WA, USA.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Krakauer', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Blasi', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute (formerly, Group Health Research Institute), Seattle, WA, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Bush', 'Affiliation': 'Optum Center for Wellbeing Research, Optum, Eden Prairie, MN.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute (formerly, Group Health Research Institute), Seattle, WA, USA.'}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Catz', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, Sacramento, CA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz009']
1224,31315471,Economic evaluation of prolonged and enhanced ECG Holter monitoring in acute ischemic stroke patients.,"Objective:  Atrial fibrillation (AF) is a major cause for recurrent stroke, has severe impact on a patient's health and imposes a high economic burden for society. Current guidelines recommend 24 h ECG monitoring (standard-of-care, SoC) to detect AF after stroke to reduce the risk of future events. However, paroxysmal AF (PAF) is difficult to detect within this period as it occurs infrequently and unpredictably. In a randomized controlled trial (Find-AF RANDOMISED ), prolonged and enhanced Holter ECG monitoring (EPM) revealed a significantly higher detection rate of AF compared to SoC, although its cost-effectiveness has not yet been investigated.  Methods:  Based on the data of FIND-AF RANDOMISED , an economic evaluation was conducted. One group received EPM for 10 days after the event, and at 3 and 6 months; the other group received SoC. Healthcare resource use and quality of life (QoL) data were measured at baseline, and after 6 and 12 months. Incremental costs and quality-adjusted life years (QALYs) between both groups were compared. Non-parametric bootstrapping and one-way-sensitivity analyses were performed.  Results:  A total of 281 patients with healthcare resource use and QoL data for all measurement points were considered in the economic evaluation (complete case analysis, CCA). The CCA yielded nonsignificant 315€ lower mean costs and 0.0013 less QALYs for patients receiving EPM with no statistically significant differences in any cost categories. Sensitivity analyses revealed robust results. Bootstrapping the results indicated moderate probability of cost-effectiveness.  Conclusions:  EPM yielded reduced not significantly different costs without affecting QoL and may be a useful strategy to detect PAF in acute ischemic stroke patients in time.",2019,yielded reduced not significantly different costs without affecting QoL and may be a useful strategy to detect PAF in acute ischemic stroke patients in time.,"['acute ischemic stroke patients', '281 patients with healthcare resource', 'acute ischemic stroke patients in time']","['Holter ECG monitoring (EPM', 'prolonged and enhanced ECG Holter monitoring', 'EPM', 'Atrial fibrillation (AF']","['quality of life (QoL) data', 'moderate probability of cost-effectiveness', 'Incremental costs and quality-adjusted life years (QALYs']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0180580', 'cui_str': 'Electrocardiographic monitoring'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0013801', 'cui_str': 'Monitoring, Holter'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0034380'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",281.0,0.097969,yielded reduced not significantly different costs without affecting QoL and may be a useful strategy to detect PAF in acute ischemic stroke patients in time.,"[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Diekmann', 'Affiliation': 'Institute for Health Care Management and Research, University of Duisburg-Essen , Essen , Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hörster', 'Affiliation': 'Institute for Health Care Management and Research, University of Duisburg-Essen , Essen , Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Evers', 'Affiliation': 'Faculty of Health, Medicine and Life Sciences, Department of Health Services Research, CAPHRI Care and Public Health Research Institute, Maastricht University , Maastricht , The Netherlands.'}, {'ForeName': 'Mickaël', 'Initials': 'M', 'LastName': 'Hiligsmann', 'Affiliation': 'Faculty of Health, Medicine and Life Sciences, Department of Health Services Research, CAPHRI Care and Public Health Research Institute, Maastricht University , Maastricht , The Netherlands.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Gelbrich', 'Affiliation': 'Institute for Clinical Epidemiology and Biometry, University of Würzburg , Würzburg , Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Gröschel', 'Affiliation': 'Department of Neurology, University Medical Centre of Johannes Gutenberg University Mainz , Mainz , Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Wachter', 'Affiliation': 'Clinic for Cardiology and Pneumology, University of Göttingen , Göttingen , Germany.'}, {'ForeName': 'Gerhard F', 'Initials': 'GF', 'LastName': 'Hamann', 'Affiliation': 'Clinic for Neurology and Neurological Rehabilitation, Bezirkskrankenhaus Günzburg , Günzburg , Germany.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Kermer', 'Affiliation': 'Clinic for Neurology, Hospital Nordwest-Krankenhaus Sanderbusch , Sande , Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Liman', 'Affiliation': 'Clinic for Neurology, University of Göttingen , Göttingen , Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weber-Krüger', 'Affiliation': 'Clinic for Cardiology and Pneumology, University of Göttingen , Göttingen , Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Wasem', 'Affiliation': 'Institute for Health Care Management and Research, University of Duisburg-Essen , Essen , Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Neumann', 'Affiliation': 'Institute for Health Care Management and Research, University of Duisburg-Essen , Essen , Germany.'}]",Current medical research and opinion,['10.1080/03007995.2019.1646000']
1225,31299810,Risk Factors for Adult Postintubation Tracheal Stenosis.,"BACKGROUND


To identify risk factors for developing adult postintubation tracheal stenosis (TS) and determine if there were patient characteristics that could serve as prognostic indicators of clinical outcomes in this patient population.
METHODS


A total of 55 patients with postintubation TS admitted to our institution between February 2009 and March 2017 (TS group) and randomly selected 86 patients admitted to the intensive care unit and intubated over the same period in whom TS was ruled out (control group) were compared. Causal factors of intubation were noted. Patient-, treatment-, and procedure/cuff site-related risk factors of TS were compared.
RESULTS


Both groups did not differ from each other by means of age and gender (P = 0.640, and P = 0.724, respectively). Compared to controls, patients with TS had a significantly higher BMI (32.8 ± 7.64 kg/m versus 25.9 ± 6.68 kg/m; p = 0.002) and were more likely to have diabetes (28.4% vs 9.82%; p = 0.0011). Patients who were previously intubated for more than 48 hours (P = 0.016) and patients treated with irradiation (P = 0.028) were significantly more likely to develop TS than control patients.
CONCLUSION


Patients with TS had a significantly higher BMI, and were more likely to have diabetes compared to controls. Patients who were previously intubated for more than 48 hours and patients treated with irradiation were more likely to develop TS than control patients.",2019,"Both groups did not differ from each other by means of age and gender (P = 0.640, and P = 0.724, respectively).","['55 patients with postintubation TS admitted to our institution between February 2009 and March 2017 (TS group) and randomly selected 86 patients admitted to the intensive care unit and intubated over the same period in whom TS was ruled out (control group', 'Adult Postintubation Tracheal Stenosis']",[],['BMI'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0040583', 'cui_str': 'Tracheal Stenosis'}]",[],[],,0.0360697,"Both groups did not differ from each other by means of age and gender (P = 0.640, and P = 0.724, respectively).","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Songu', 'Affiliation': 'Department of Otorhinolaryngology, Izmir Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Yilmaz', 'Initials': 'Y', 'LastName': 'Ozkul', 'Affiliation': ''}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000005513']
1226,31298194,"Fetal Repair of Open Neural Tube Defects: Ethical, Legal, and Social Issues.","Open neural tube defects or myelomeningoceles are a common congenital condition caused by failure of closure of the neural tube early in gestation, leading to a number of neurologic sequelae including paralysis, hindbrain herniation, hydrocephalus and neurogenic bowel and bladder dysfunction. Traditionally, the condition was treated by closure of the defect postnatally but a recently completed randomized controlled trial of prenatal versus postnatal closure demonstrated improved neurologic outcomes in the prenatal closure group. Fetal surgery, or more precisely maternal-fetal surgery, raises a number of ethical issues that we address including who the patient is, informed consent, surgical innovation and equipoise as well maternal assumption of risk. As the procedure becomes more widely adopted into practice, we suggest close monitoring of new fetal surgery centers, in order to ensure that the positive results of the trial are maintained without increased risk to both the mother and fetus.",2019,"Open neural tube defects or myelomeningoceles are a common congenital condition caused by failure of closure of the neural tube early in gestation, leading to a number of neurologic sequelae including paralysis, hindbrain herniation, hydrocephalus and neurogenic bowel and bladder dysfunction.",[],[],['neurologic outcomes'],[],[],"[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",,0.041154,"Open neural tube defects or myelomeningoceles are a common congenital condition caused by failure of closure of the neural tube early in gestation, leading to a number of neurologic sequelae including paralysis, hindbrain herniation, hydrocephalus and neurogenic bowel and bladder dysfunction.","[{'ForeName': 'Julia A E', 'Initials': 'JAE', 'LastName': 'Radic', 'Affiliation': ''}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Illes', 'Affiliation': ''}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McDonald', 'Affiliation': ''}]",Cambridge quarterly of healthcare ethics : CQ : the international journal of healthcare ethics committees,['10.1017/S0963180119000409']
1227,31295558,Validity and reliability of test strips for the measurement of salivary nitrite concentration with and without the use of mouthwash in healthy adults.,"The nitrate (NO 3 - )-nitrite (NO 2 - )-nitric oxide (NO) pathway has received considerable interest in recent years as a potential target for nutritional interventions designed to increase NO production, and elicit therapeutic effects in humans. In particular, studies have evaluated the effects of supplemental dietary NO 3 - , which serves as a 'substrate' for this pathway, on numerous different health outcomes. One challenge has been to evaluate compliance with the NO 3 -  interventions. A recent advance in this field has been the development of a non-invasive, simple and rapid method to measure nitrite concentrations in saliva using small test salivary strips. In the present study, ten healthy adults were recruited to a randomised, crossover study and received an acute dose of NO 3 - -rich beetroot juice (BJ) after rinsing their mouth with either water or commercially available antibacterial mouthwash. Salivary NO 3 -  and NO 2 -  concentrations were measured at baseline and up to 5 h after BJ consumption using the gold-standard chemiluminescence and a colorimetric Griess assay. In addition, two salivary test strips (Berkeley Test strips, CA, USA) were used to measure NO 2 - concentrations at the same time points. Five observers read the strips and inter- and intra-observer reliability was measured. The Bland-Altman method was used to provide a visual representation of the agreement between the methods used to evaluate salivary NO 3 - /NO 2 - concentration. Sialin concentrations were measured at baseline and up to 5 h after BJ consumption. BJ elevated salivary NO 3 -  and NO 2 -  concentrations when the mouth was rinsed with water (both P < 0.01), as assessed via both chemiluminescence and Griess methods. Rinsing the mouth with antibacterial mouthwash attenuated markedly the increase in NO 2 -  (P < 0.001), while NO 3 - concentrations were unaffected (P > 0.05). The Intra-Class Coefficients of Correlation (ICC) showed a high inter- and intra-observer reliability (r > 0.8). A significant positive correlation was found between absolute salivary NO 2 -  concentrations measured by strips and Griess and chemiluminescence methods (rho = 0.83 and 0.77, respectively) and also when expressed as changes in salivary NO 2 -  concentrations (rho = 0.80 and 0.79, respectively). Bland Altman analysis indicated a poor agreement for absolute NO 2 -  concentrations between salivary strips and the chemiluminescence and Griess methods. A small significant negative correlation was found between changes in salivary sialin and salivary NO 2 - concentrations (r = -0.20, P = 0.04). A non-significant positive correlation was observed between the change in salivary sialin and salivary NO 3 - concentrations (r = 0.18, P = 0.06). This study suggests that commercially available salivary NO 2 -  test strips provide a reasonable surrogate marker for monitoring changes in salivary NO 2 -  concentrations in humans. However, the strips do not provide accurate estimates of absolute NO 2 -  concentrations.",2019,"Rinsing the mouth with antibacterial mouthwash attenuated markedly the increase in NO 2 -  (P < 0.001), while NO 3 - concentrations were unaffected (P > 0.05).","['healthy adults', 'ten healthy adults']","['Salivary', 'NO 3 - -rich beetroot juice (BJ) after rinsing their mouth with either water or commercially available antibacterial mouthwash']","['Sialin concentrations', 'salivary sialin and salivary NO 2 - concentrations', 'NO 3 -  and NO 2 -  concentrations', 'absolute salivary NO 2 -  concentrations measured by strips and Griess and chemiluminescence methods', 'salivary sialin and salivary NO 3 - concentrations', 'NO 2 ', 'BJ elevated salivary NO 3 -  and NO 2 -  concentrations']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0162524', 'cui_str': 'Chemiluminescence'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",10.0,0.0390093,"Rinsing the mouth with antibacterial mouthwash attenuated markedly the increase in NO 2 -  (P < 0.001), while NO 3 - concentrations were unaffected (P > 0.05).","[{'ForeName': 'Abrar M', 'Initials': 'AM', 'LastName': 'Babateen', 'Affiliation': 'Human Nutrition Research Centre, Institute of Cellular Medicine, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK; Faculty of Applied Medical Sciences, Clinical Nutrition Department, Umm Al-Qura University, Makkah, Saudi Arabia. Electronic address: a.m.o.babateen2@ncl.ac.uk.'}, {'ForeName': 'Oliver M', 'Initials': 'OM', 'LastName': 'Shannon', 'Affiliation': 'Human Nutrition Research Centre, Institute of Cellular Medicine, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Institute of Cellular Medicine, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Siervo', 'Affiliation': ""Human Nutrition Research Centre, Institute of Cellular Medicine, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK; School of Life Sciences, The University of Nottingham Medical School, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}]",Nitric oxide : biology and chemistry,['10.1016/j.niox.2019.07.002']
1228,31313410,Assessment of real-time and quantitative changes in renal hemodynamics in healthy overweight males: Contrast-enhanced ultrasonography vs para-aminohippuric acid clearance.,"OBJECTIVE


To determine the ability of renal contrast-enhanced ultrasonography (CEUS) to detect acute drug-induced changes in renal perfusion (using the glucagon-like peptide (GLP)-1 receptor agonist exenatide and nitric oxide [NO]-synthase inhibitor L-N G  -monomethyl arginine [l-NMMA]), and assess its correlation with gold standard-measured effective renal plasma flow in humans.
METHODS


In this prespecified exploratory analysis of a placebo-controlled cross-over study, renal hemodynamics was assessed in 10 healthy overweight males (aged 20-27 years; BMI 26-31 kg/m 2  ) over two separate testing days; during placebo (isotonic saline) and subsequent exenatide infusion (Day-A), and during l-NMMA, and subsequent exenatide plus l-NMMA infusion (Day-B). Renal cortical microvascular blood flow was estimated following microbubble infusion and CEUS destruction-refilling-sequences. Renal cortical microvascular blood flow was compared with simultaneously measured effective renal plasma flow in humans, derived from para-aminohippuric acid-clearance methodology.
RESULTS


On Day-A, effective renal plasma flow increased by 68 [26-197] mL/min/1.73 m 2  during exenatide vs placebo infusion (+17%; P = .015). In parallel, exenatide increased renal cortical microvascular blood flow, from 2.42 × 10 -4  [6.54 × 10 -5  -4.66 × 10 -4  ] AU to 4.65 × 10 -4  [2.96 × 10 -4  -7.74 × 10 -4  ] AU (+92%; P = .027). On Day-B, effective renal plasma flow and renal cortical microvascular blood flow were reduced by l-NMMA, with no significant effect of concomitant exenatide on renal hemodynamic-indices assessed by either technique. Effective renal plasma flow correlated with renal cortical microvascular blood flow on Day-A (r = .533; P = .027); no correlation was found on Day-B.
CONCLUSIONS


Contrast-enhanced ultrasonography can detect acute drug-induced changes human renal hemodynamics. CEUS-assessed renal cortical microvascular blood flow moderately associates with effective renal plasma flow, particularly when perfusion is in normal-to-high range. Renal CEUS cannot replace effective renal plasma flow measurements, but may be a complementary tool to characterize regional kidney perfusion.",2019,Effective renal plasma flow correlated with renal cortical microvascular blood flow on Day-A (r = .533; P = .027),"['humans', '10 healthy overweight males (aged 20-27\xa0years; BMI 26-31\xa0kg/m 2  ) over two separate testing days; during', 'healthy overweight males']","['exenatide vs placebo', 'renal contrast-enhanced ultrasonography (CEUS', 'exenatide', 'ultrasonography vs para-aminohippuric acid clearance', 'placebo', 'placebo (isotonic saline) and subsequent exenatide infusion (Day-A), and during l-NMMA, and subsequent exenatide plus l-NMMA infusion']","['renal cortical microvascular blood flow', 'effective renal plasma flow and renal cortical microvascular blood flow', 'renal hemodynamics', 'Effective renal plasma flow', 'renal hemodynamic-indices', 'Renal cortical microvascular blood flow', 'effective renal plasma flow']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0030123', 'cui_str': 'aminohippuric acid'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0069477', 'cui_str': 'NG-Monomethyl-L-Arginine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0206088', 'cui_str': 'ERPF'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",10.0,0.0419492,Effective renal plasma flow correlated with renal cortical microvascular blood flow on Day-A (r = .533; P = .027),"[{'ForeName': 'Marcel H A', 'Initials': 'MHA', 'LastName': 'Muskiet', 'Affiliation': 'Department of Internal Medicine, Diabetes Center, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Emanuel', 'Affiliation': 'Department of Internal Medicine, Diabetes Center, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smits', 'Affiliation': 'Department of Internal Medicine, Diabetes Center, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Tonneijck', 'Affiliation': 'Department of Internal Medicine, Diabetes Center, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Rick I', 'Initials': 'RI', 'LastName': 'Meijer', 'Affiliation': 'Department of Internal Medicine, Diabetes Center, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap A', 'Initials': 'JA', 'LastName': 'Joles', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Erik H', 'Initials': 'EH', 'LastName': 'Serné', 'Affiliation': 'Department of Internal Medicine, Diabetes Center, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Department of Internal Medicine, Diabetes Center, Amsterdam University Medical Centers, location VUMC, Amsterdam, The Netherlands.'}]","Microcirculation (New York, N.Y. : 1994)",['10.1111/micc.12580']
1229,31307814,Near-infrared fluorescence imaging improves the nodal yield in neck dissection in oral cavity cancer - A randomized study.,"INTRODUCTION


Lymph node yield (LNY) in neck dissection has been identified as a prognostic factor in oral cavity cancer. The purpose of this study was to investigate the impact of additional use of optical imaging on LNY in therapeutic ND in oral cancer.
METHODS


Consecutive patients with oral squamous cell carcinoma with clinical neck metastasis planned for primary tumor resection were randomized to conventional neck dissection or near-infrared fluorescence (NIRF)-guided neck dissection, respectively. In the intervention group, patients were injected with ICG-Nanocoll prior to surgery. Intraoperatively, an optical hand-held camera system was used for lymph node identification. Also, NIRF imaging of the neck specimen was performed, and optical signals were pinned with needle markings to guide the pathological examination. The endpoint of the study was LNY per neck side in levels Ib-III.
RESULTS


31 patients were included with 18 neck sides in the control group and 18 neck sides in the intervention group for evaluation. During NIRF-guided ND, individual lymph nodes could be identified by a bright fluorescent signal and individual tumor-related drainage patterns could be observed in the neck. The LNY in the intervention group was significantly higher compared to the control group (p = 0.032) with a mean of 24 LN (range: 12-33 LN in levels Ib-III compared to 18 LN (range: 10-36 LN) in the control group, respectively.
CONCLUSIONS


NIRF-guided ND significantly improved the nodal yield compared to the control group. Intraoperative real-time optical imaging enabled direct visualization of tumor-related drainage patterns within the neck lymphatics.",2019,"The LNY in the intervention group was significantly higher compared to the control group (p = 0.032) with a mean of 24 LN (range: 12-33 LN in levels Ib-III compared to 18 LN (range: 10-36 LN) in the control group, respectively.
","['31 patients were included with 18 neck sides in the control group and 18 neck sides in the intervention group for evaluation', 'Consecutive patients with oral squamous cell carcinoma with clinical neck metastasis planned for primary tumor resection']","['optical imaging on LNY', 'ICG-Nanocoll prior to surgery', 'conventional neck dissection or near-infrared fluorescence (NIRF)-guided neck dissection, respectively']","['nodal yield', 'LNY per neck side in levels Ib-III']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0441987', 'cui_str': 'Side (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0247623', 'cui_str': 'nanocoll'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0398395', 'cui_str': 'Neck Dissection'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}]",36.0,0.029562,"The LNY in the intervention group was significantly higher compared to the control group (p = 0.032) with a mean of 24 LN (range: 12-33 LN in levels Ib-III compared to 18 LN (range: 10-36 LN) in the control group, respectively.
","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Christensen', 'Affiliation': 'Department of Otolaryngology, Head & Neck Surgery and Audiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark; Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: anders.christensen.03@regionh.dk.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Juhl', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: karina.juhl@sund.ku.dk.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Kiss', 'Affiliation': 'Department of Pathology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: katalin.kiss@regionh.dk.'}, {'ForeName': 'Giedrius', 'Initials': 'G', 'LastName': 'Lelkaitis', 'Affiliation': 'Department of Pathology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: giedrius.lelkaitis@regionh.dk.'}, {'ForeName': 'Birgitte Wittenborg', 'Initials': 'BW', 'LastName': 'Charabi', 'Affiliation': 'Department of Otolaryngology, Head & Neck Surgery and Audiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: birgitte.wittenborg.charabi@regionh.dk.'}, {'ForeName': 'Jann', 'Initials': 'J', 'LastName': 'Mortensen', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: jann.mortensen@regionh.dk.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kjær', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: andreas.kjaer@regionh.dk.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Buchwald', 'Affiliation': 'Department of Otolaryngology, Head & Neck Surgery and Audiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen East, Denmark. Electronic address: christian.von.buchwald@regionh.dk.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2019.06.039']
1230,31303297,"The effect of report cards on the coverage of maternal and neonatal health care: a factorial, cluster-randomised controlled trial in Uttar Pradesh, India.","BACKGROUND


Report cards are a prominent strategy to increase the ability of citizens to express their view, improve public accountability, and foster community participation in the provision of health services in low-income and middle-income countries. In India, social accountability interventions that incorporate report cards and community meetings have been implemented at scale, attracting considerable policy attention, but there is little evidence on their effectiveness in improving health. We aimed to evaluate the effect of report cards, which contain information on village-level indicators of maternal and neonatal health care, and participatory meetings targeted at health providers and community members (including local leaders) on the coverage of maternal and neonatal health care in Uttar Pradesh, India.
METHODS


We conducted a repeated cross-sectional, 2 × 2 factorial, cluster-randomised controlled trial, in which each cluster was a village (rural) or ward (urban). The clusters were randomly assigned to one of four groups: the provider group, in which we shared report cards and held participatory meetings with providers of maternal and neonatal health services; the community group, in which we shared report cards and held participatory meetings with community members (including local leaders); the providers and community group, in which report cards were targeted at both health providers and the community; and the control group, in which report cards were not shared with anyone. We generated these report cards by collating data from household surveys and shared the report cards with the recipients (as determined by their assigned groups) in participatory meetings. The primary outcome was the proportion of women who had at least four antenatal care visits (ie, attended a clinic or were visited at home by a health-care worker) during their last pregnancy. We measured outcomes with cross-sectional household surveys that were taken at baseline, at a first follow-up (after 8 months of the intervention), and at a second follow-up (21 months after the start of the intervention). Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN11070792.
FINDINGS


We surveyed eligible women for the baseline survey between Jan 13, and Feb 5, 2015. We then randomly assigned 44 clusters to the provider group, 45 clusters to the community group, 45 clusters to the provider and community group, and 44 clusters to the control group. Report cards of collated survey data were provided to recipient groups, as per their random allocation, in October, 2015, and in September, 2016. We ran the first follow-up survey between May 16 and June 10, 2016. We ran the second follow-up survey between June 18 and July 18, 2017. We measured the primary outcome in 3133 women (795 in the provider group, 781 in the community group, 798 in the provider and community group, and 759 in the control group) who gave birth during implementation of the intervention, between Feb 1, 2016, and July 18, 2017 (the end of the second follow-up survey). The report card intervention did not significantly affect the proportion of women who had at least four antenatal care visits (provider vs non-provider: odds ratio 0·85, 95% CI 0·65-1·13; community vs non-community: 0·86, 0·65-1·13).
INTERPRETATION


Maternal health report cards containing information on village performance, targeted at either the community or health providers, had no detectable effect on the coverage of maternal and neonatal health care. Future research should seek to understand how the content of information and the delivery of report cards affect the success of this type of social accountability intervention.
FUNDING


Merck Sharp and Dohme.",2019,"The report card intervention did not significantly affect the proportion of women who had at least four antenatal care visits (provider vs non-provider: odds ratio 0·85, 95% CI 0·65-1·13; community vs non-community: 0·86, 0·65-1·13).
","['3133 women (795 in the provider group, 781 in the community group, 798 in the provider and community group, and 759 in the control group) who gave birth during implementation of the intervention, between Feb 1, 2016, and July 18, 2017 (the end of the second follow-up survey', 'repeated cross-sectional, 2\u2008×\u20082 factorial, cluster-randomised controlled trial, in which each cluster was a village (rural) or ward (urban', 'health providers and community members (including local leaders) on the coverage of maternal and neonatal health care in Uttar Pradesh, India', 'surveyed eligible women for the baseline survey between Jan 13, and Feb 5, 2015']","['provider group, in which we shared report cards and held participatory meetings with providers of maternal and neonatal health services; the community group, in which we shared report cards and held participatory meetings with community members (including local leaders); the providers and community group, in which report cards were targeted at both health providers and the community; and the control group, in which report cards were not shared with anyone']","['proportion of women who had at least four antenatal care visits (ie, attended a clinic or were visited at home by a health-care worker']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4042838', 'cui_str': 'Health of Newborn Infants'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4042838', 'cui_str': 'Health of Newborn Infants'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1553387', 'cui_str': 'Hold'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",3133.0,0.104485,"The report card intervention did not significantly affect the proportion of women who had at least four antenatal care visits (provider vs non-provider: odds ratio 0·85, 95% CI 0·65-1·13; community vs non-community: 0·86, 0·65-1·13).
","[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Fabbri', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Dutt', 'Affiliation': 'Sambodhi Research and Communications, Noida, Uttar Pradesh, India.'}, {'ForeName': 'Vasudha', 'Initials': 'V', 'LastName': 'Shukla', 'Affiliation': 'Sambodhi Research and Communications, Noida, Uttar Pradesh, India.'}, {'ForeName': 'Kultar', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'Sambodhi Research and Communications, Noida, Uttar Pradesh, India.'}, {'ForeName': 'Nehal', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Sambodhi Research and Communications, Noida, Uttar Pradesh, India.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Powell-Jackson', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: Timothy.Powell-Jackson@lshtm.ac.uk.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30254-2']
1231,30902579,Birthing ball versus pethidine and haloperidol in satisfaction with childbirth.,"OBJECTIVE


To determine the effects on maternal satisfaction of the use of the birthing ball as a method of pain relief compared to the subcutaneous administration of pethidine (50mg) and haloperidol (2.5mg), during the latent phase of labour.
METHOD


Randomised, unicentric, parallel and controlled clinical trial.
PARTICIPANTS


Low-risk pregnant women hospitalised in a pathological pregnancy ward at the Gregorio Marañón University General Hospital (Madrid) due to prolonged pregnancy, premature rupture of membranes, or labour prodromes.
INTERVENTION


once the patient's labour had become painful, a series of pre-established movements were implemented with a birthing ball in the intervention group, or pethidine and haloperidol were administered at the same dose subcutaneously. After the intervention and on the post-natal ward, satisfaction was measured with the Mackey Satisfaction Childbirth scale, validated in Spanish in 2016, in the first 48-72hours after delivery.
ANALYSIS


group comparisons: Student's t for continuous variables and Chi-squared for categorical variables. Significance at p<0.05.
RESULTS


The maternal satisfaction was significantly higher in the experimental group than in the comparison group, in all the domains of the scale: obstetrician (4.24/3.87), dilatation (4.02/3.35), second stage (4.27/3.67), newborn (4.72/4.43), accompaniment and comfort (4.78/4.44). There were, however, no statistically significant differences in the midwife subscale, although the scores were equally high (4.65/4.45).
CONCLUSION


Using birthing balls during the latent phase of labour increases women's satisfaction with their labour process more than administering pethidine and haloperidol during this period.",2019,"The maternal satisfaction was significantly higher in the experimental group than in the comparison group, in all the domains of the scale: obstetrician (4.24/3.87), dilatation (4.02/3.35), second stage (4.27/3.67), newborn (4.72/4.43), accompaniment and comfort (4.78/4.44).","['satisfaction with childbirth', 'Low-risk pregnant women hospitalised in a pathological pregnancy ward at the Gregorio Marañón University General Hospital (Madrid) due to prolonged pregnancy, premature rupture of membranes, or labour prodromes']","['pethidine', 'pethidine and haloperidol', 'haloperidol']","['maternal satisfaction', 'Mackey Satisfaction Childbirth scale', 'pain relief', 'midwife subscale']","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0240805', 'cui_str': 'Prodrome'}]","[{'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0222045'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}]",,0.0320529,"The maternal satisfaction was significantly higher in the experimental group than in the comparison group, in all the domains of the scale: obstetrician (4.24/3.87), dilatation (4.02/3.35), second stage (4.27/3.67), newborn (4.72/4.43), accompaniment and comfort (4.78/4.44).","[{'ForeName': 'Julita', 'Initials': 'J', 'LastName': 'Fernández-Arranz', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, España. Electronic address: info@aquanatal.es.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'Pedraz-Marcos', 'Affiliation': 'Departamento de Enfermería, Universidad Autónoma de Madrid, Madrid, España.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Palmar-Santos', 'Affiliation': 'Unidad de Apoyo a la Investigación, Hospital General Universitario Gregorio Marañón, Madrid, España.'}, {'ForeName': 'M Nieves', 'Initials': 'MN', 'LastName': 'Moro-Tejedor', 'Affiliation': 'Unidad de Apoyo a la Investigación, Hospital General Universitario Gregorio Marañón, Madrid, España.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.02.003']
1232,30924310,Amylose resistant starch (HAM-RS2) supplementation increases the proportion of Faecalibacterium bacteria in end-stage renal disease patients: Microbial analysis from a randomized placebo-controlled trial.,"INTRODUCTION


Many of the deleterious effects associated with chronic kidney disease (CKD) are secondary to the resultant systemic inflammation. The gut microbial changes caused by CKD are thought to perpetuate systemic inflammation. Therefore, strategies aimed at modulating the gut microbiota may be helpful in reducing complications associated with CKD. We hypothesized that supplementation with high-amylose maize resistant starch type 2 (HAM-RS2) would beneficially alter the gut microbiome and lead to lower levels of systemic inflammation.
METHODS


A double-blind, parallel, randomized, placebo-controlled trial was performed comparing dietary supplementation of HAM-RS2 with placebo in patients with end-stage CKD. Fecal microbial data were obtained from a subset of patients after DNA extraction and 16s sequencing.
FINDINGS


Supplementation of HAM-RS2 led to a decrease in serum urea, IL-6, TNFα, and malondialdehyde (P < 0.05). The Faecalibacterium genus was significantly increased in relative abundance following HAM-RS2 supplementation (HAM-RS2-Day 0: 0.40 ± 0.50 vs. HAM-RS2-Day 56: 3.21 ± 4.97 P = 0.03) and was unchanged by placebo (Control-Day 0: 0.72 ± 0.72 vs. Control-Day 56: 0.83 ± 1.57 P = 0.5).
DISCUSSION


Supplementation of amylose resistant starch, HAM-RS2, in patients with CKD led to an elevation in Faecalibacterium and decrease in systemic inflammation. Microbial manipulation in CKD patients by using the prebiotic fiber may exert an anti-inflammatory effect through an elevation in the bacterial genera Faecalibacterium.",2019,"The Faecalibacterium genus was significantly increased in relative abundance following HAM-RS2 supplementation (HAM-RS2-Day 0: 0.40 ± 0.50 vs. HAM-RS2-Day 56: 3.21 ± 4.97 P = 0.03) and was unchanged by placebo (Control-Day 0: 0.72 ± 0.72 vs. Control-Day 56: 0.83 ± 1.57 P = 0.5).
","['CKD patients', 'end-stage renal disease patients', 'patients with end-stage CKD', 'patients with CKD']","['supplementation with high-amylose maize resistant starch type 2 (HAM-RS2', 'placebo', 'HAM-RS2 with placebo', 'Amylose resistant starch (HAM-RS2) supplementation']","['serum urea, IL-6, TNFα, and malondialdehyde', 'relative abundance', 'systemic inflammation', 'Faecalibacterium bacteria', 'Fecal microbial data']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0002732', 'cui_str': 'Amylose'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C3492143', 'cui_str': 'HAM-RS2'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0856666', 'cui_str': 'Serum urea'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1229075', 'cui_str': 'Faecalibacterium'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}]",,0.225053,"The Faecalibacterium genus was significantly increased in relative abundance following HAM-RS2 supplementation (HAM-RS2-Day 0: 0.40 ± 0.50 vs. HAM-RS2-Day 56: 3.21 ± 4.97 P = 0.03) and was unchanged by placebo (Control-Day 0: 0.72 ± 0.72 vs. Control-Day 56: 0.83 ± 1.57 P = 0.5).
","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Laffin', 'Affiliation': 'Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Tayebi Khosroshahi', 'Affiliation': 'Kidney Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Heekuk', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Luke J', 'Initials': 'LJ', 'LastName': 'Laffin', 'Affiliation': 'Section of Preventive Cardiology, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Madsen', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Hossein Samadi', 'Initials': 'HS', 'LastName': 'Kafil', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Abedi', 'Affiliation': 'Department of Nanotechnology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Shiralizadeh', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Nosratola D', 'Initials': 'ND', 'LastName': 'Vaziri', 'Affiliation': 'Division of Nephrology, University of California, Irvine, California, USA.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12753']
1233,30966821,Impact of a cardiovascular disease risk screening result on preventive behaviour in asymptomatic participants of the ROBINSCA trial.,"INTRODUCTION


A teachable moment for preventive behavioural change can occur when asymptomatic individuals receive their cardiovascular disease screening result. This study investigated prevention-seeking behaviour and compliance with preventive treatment of participants of the population-based Risk Or Benefit IN Screening for CArdiovascular disease (ROBINSCA) trial after receiving a screening result.
METHODS


Asymptomatic Dutch individuals ( n  = 43,447) were randomly assigned (1:1:1) to screening for cardiovascular disease by either traditional risk assessment (intervention arm A), or determining the amount of coronary artery calcification (intervention arm B), or to usual care (control arm). A random sample ( n  = 600) of ROBINSCA participants with a screening result (arms A and B) received an online questionnaire (in 2017) to measure the impact of a cardiovascular disease screening result in low and increased (arm A: risk > 10%; arm B: Agatston ≥ 100) risk groups.
RESULTS


Of all respondents (438/600; 73%) 63.5% were men and the mean age ( ± standard deviation) was 63.8 ± 6.9 years. Individuals with an increased coronary artery calcification score consulted their general practitioner more often compared to increased risk individuals from arm A: 140/149 (94%) and 86/137 (62.8%), respectively ( P  < 0.001). Current use of blood pressure and cholesterol-lowering drugs was significantly higher in the increased coronary artery calcification score group (108/140; 77.1%), compared to the group with an increased traditional risk (35/80, 43.8%;  P  < 0.001). Self-reported compliance was high (98.1-100%).
CONCLUSION


Receiving the screening result might be a teachable moment that can enhance cardiovascular disease prevention-seeking behaviour through consulting a general practitioner and high compliance with preventive treatment. The impact of the screening result was more profound in the increased coronary artery calcification score group. Trial registration number: NTR6471.",2019,"Individuals with an increased coronary artery calcification score consulted their general practitioner more often compared to increased risk individuals from arm A: 140/149 (94%) and 86/137 (62.8%), respectively ( P < 0.001).","['participants of the population-based Risk Or Benefit IN Screening for CArdiovascular disease (ROBINSCA) trial after receiving a screening result', 'Of all respondents (438/600; 73%) 63.5% were men and the mean age (\u2009±\u2009standard deviation) was 63.8\u2009±\u20096.9 years', 'Asymptomatic Dutch individuals ( n\u2009=\u200943,447', 'asymptomatic participants of the ROBINSCA trial']","['online questionnaire', 'cardiovascular disease screening result in low and increased (arm A: risk\u2009>\u200910%; arm B: Agatston\u2009≥\u2009100) risk groups', 'screening for cardiovascular disease by either traditional risk assessment (intervention arm A), or determining the amount of coronary artery calcification (intervention arm B), or to usual care (control arm', 'cardiovascular disease risk screening']","['traditional risk', 'blood pressure and cholesterol-lowering drugs', 'coronary artery calcification score']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",43447.0,0.0707352,"Individuals with an increased coronary artery calcification score consulted their general practitioner more often compared to increased risk individuals from arm A: 140/149 (94%) and 86/137 (62.8%), respectively ( P < 0.001).","[{'ForeName': 'Sabine Jam', 'Initials': 'SJ', 'LastName': 'Denissen', 'Affiliation': '1 Department of Public Health, Erasmus Medical Centre, The Netherlands.'}, {'ForeName': 'Carlijn M', 'Initials': 'CM', 'LastName': 'van der Aalst', 'Affiliation': '1 Department of Public Health, Erasmus Medical Centre, The Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Vonder', 'Affiliation': '2 Centre for Medical Imaging North-East Netherlands (CMI-NEN), University of Groningen, University Medical Centre Groningen, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Oudkerk', 'Affiliation': '2 Centre for Medical Imaging North-East Netherlands (CMI-NEN), University of Groningen, University Medical Centre Groningen, The Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'de Koning', 'Affiliation': '1 Department of Public Health, Erasmus Medical Centre, The Netherlands.'}]",European journal of preventive cardiology,['10.1177/2047487319843396']
1234,32409760,Comparison of Centella with Flavonoids for Treatment of Symptoms in Hemorrhoidal Disease and After Surgical Intervention: A Randomized Clinical Trial.,"Phlebotonics' effects were evaluated to reduce time-to-stop bleeding and anal irritation in 130 patients who complained of hemorrhoidal disease (HD); bleeding and pain after hemorrhoidectomy (31 patients) and hemorrhoidal thrombosis (34 patients) in the short time. Sixty patients were randomized to receive the routine treatment (both conservative and surgical) (control Group C). The treated group (both conservative and surgical) was divided into two subgroups: one treated with flavonoids (Group A, n = 73), the other with Centella (Group B, n = 66). Time-to-stop bleeding was checked at baseline and checkups (0 up to day 42). Healing was estimated with Kaplan-Meier method, the Kruskal-Wallis test estimated changes in the VAS scores. The HD median time-to-stop bleeding was 2 weeks for Groups A and B; 3 weeks for Group C. VAS scores comparison among Groups (irritation): A vs C, p = 0.007; B vs C, p = 0.041; and A vs B, p = 0.782 resulted respectively. As for operated hemorrhoids, the time-to-stop bleeding was 3 and 4 weeks in Groups A and B and 5 in Group C. Histopathology showed an association between flavonoids and piles' fibrosis (p = 0.008). Phlebotonics in HD, as well as after surgery, showed significant beneficial effects. Flavonoids are the most effective phlebotonics against bleeding and anal irritation.",2020,Phlebotonics' effects were evaluated to reduce time-to-stop bleeding and anal irritation in 130 patients who complained of hemorrhoidal disease (HD); bleeding and pain after hemorrhoidectomy (31 patients) and hemorrhoidal thrombosis (34 patients) in the short time.,"['Hemorrhoidal Disease and After Surgical Intervention', 'Groups (irritation', 'Sixty patients', '130 patients who complained of hemorrhoidal disease (HD); bleeding and pain after hemorrhoidectomy (31 patients) and hemorrhoidal thrombosis (34 patients) in the short time']","['routine treatment (both conservative and surgical) (control Group C', 'Flavonoids', 'Centella with Flavonoids', 'flavonoids']","['time-to-stop bleeding', 'Time-to-stop bleeding', 'HD median time-to-stop bleeding', 'time-to-stop bleeding and anal irritation', 'Healing', 'VAS scores']","[{'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0936041', 'cui_str': 'Hydrocotyle'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1735348', 'cui_str': 'Anal irritation'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",130.0,0.0194777,Phlebotonics' effects were evaluated to reduce time-to-stop bleeding and anal irritation in 130 patients who complained of hemorrhoidal disease (HD); bleeding and pain after hemorrhoidectomy (31 patients) and hemorrhoidal thrombosis (34 patients) in the short time.,"[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Chiaretti', 'Affiliation': 'Department of General Surgery and Specialties ""Paride Stefanini"", Sapienza University of Rome, Rome, 00161, Italy. massimo.chiaretti@uniroma1.it.'}, {'ForeName': 'Danilo Alunni', 'Initials': 'DA', 'LastName': 'Fegatelli', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pappalardo', 'Affiliation': 'Department of General Surgery and Specialties ""Paride Stefanini"", Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Michele Dello Spedale', 'Initials': 'MDS', 'LastName': 'Venti', 'Affiliation': 'Department of Molecular Medicine, Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Annalisa Italia', 'Initials': 'AI', 'LastName': 'Chiaretti', 'Affiliation': 'Department of General Surgery and Specialties ""Paride Stefanini"", Sapienza University of Rome, Rome, 00161, Italy.'}]",Scientific reports,['10.1038/s41598-020-64772-0']
1235,31310310,"Therapy of Hypoparathyroidism With rhPTH(1-84): A Prospective, 8-Year Investigation of Efficacy and Safety.","CONTEXT


Conventional treatment of hypoparathyroidism is associated with decreased renal function and increased bone mineral density (BMD).
OBJECTIVE


To evaluate the effects of 8 years of recombinant human parathyroid hormone (1-84) [rhPTH(1-84)] therapy on key biochemical and densitometric indices.
DESIGN


Prospective open-label trial.
SETTING


Tertiary medical center.
PARTICIPANTS


Twenty-four subjects with hypoparathyroidism.
INTERVENTION


Treatment with rhPTH(1-84) for 8 years.
MAIN OUTCOME MEASURES


Supplemental calcium and vitamin D requirements, serum calcium and phosphorus levels, calcium-phosphate product, urinary calcium excretion, estimated glomerular filtration rate (eGFR) and BMD.
RESULTS


PTH therapy was associated with progressive reduction in supplemental calcium (57%; P < 0.01) and active vitamin D (76%; P < 0.001) requirements over 8 years. Serum calcium concentration was stable; urinary calcium excretion declined 38% (P < 0.01). eGFR remained stable and was related to baseline eGFR and serum calcium levels. Calcium-phosphate product was below the recommended limit; serum phosphorus remained within normal range. Lumbar spine and total hip BMD increased, peaking at 4 (mean ± SE, 4.6% ± 1.5%; P = 0.01) and 8 years (2.6% ± 1.1%; P = 0.02), whereas femoral neck BMD did not change and one-third radius BMD decreased (mean ± SE, -3.5% ± 1.1%; P = 0.001). BMD at all sites was higher throughout the 8 years than in the age- and sex-matched reference population. Hypercalcemia and hypocalcemia were uncommon.
CONCLUSION


rhPTH(1-84) is a safe and effective treatment for hypoparathyroidism for 8 years. Long-term reductions in supplemental requirements and biochemical improvements with stable renal function are maintained.",2019,"RESULTS


PTH therapy was associated with a progressive reduction in supplemental calcium (57%; p < 0.01) and active vitamin D (76%; p < 0.001) requirements over 8 years.","['Hypoparathyroidism with rhPTH(1-84', '24 hypoparathyroid subjects', 'Tertiary medical center']",['recombinant human parathyroid hormone (1-84) [rhPTH(1-84'],"['progressive reduction in supplemental calcium', 'Lumbar spine and total hip BMD', 'active vitamin D', 'Hypercalcemia and hypocalcemia', 'Supplemental calcium and vitamin D requirements, serum calcium and phosphorus levels, calcium-phosphate product, urinary calcium excretion, estimated glomerular filtration rate (eGFR) and bone mineral density (BMD', 'bone mineral density (BMD', 'radius BMD', 'femoral neck BMD', 'BMD', 'urinary calcium excretion', 'Serum calcium concentration', 'baseline eGFR and serum calcium levels']","[{'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0020063', 'cui_str': 'hPTH(1-84)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C3811844'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0133497,"RESULTS


PTH therapy was associated with a progressive reduction in supplemental calcium (57%; p < 0.01) and active vitamin D (76%; p < 0.001) requirements over 8 years.","[{'ForeName': 'Yu-Kwang Donovan', 'Initials': 'YD', 'LastName': 'Tay', 'Affiliation': 'Department of Medicine, Division of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Tabacco', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'Cusano', 'Affiliation': 'Department of Medicine, Division of Endocrinology Lenox Hill Hospital, New York, New York.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine, Division of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Omeragic', 'Affiliation': 'Department of Medicine, Division of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Rukshana', 'Initials': 'R', 'LastName': 'Majeed', 'Affiliation': 'Department of Medicine, Division of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Maximo', 'Initials': 'M', 'LastName': 'Gomez Almonte', 'Affiliation': 'Department of Medicine, Division of Cardiology, Wyckoff Heights Medical Center, New York, New York.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Bilezikian', 'Affiliation': 'Department of Medicine, Division of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Mishaela R', 'Initials': 'MR', 'LastName': 'Rubin', 'Affiliation': 'Department of Medicine, Division of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00893']
1236,31290981,Glucocorticoid Replacement Affects Serum Adiponectin Levels and HDL-C in Patients With Secondary Adrenal Insufficiency.,"CONTEXT


Low serum adiponectin and high-density lipoprotein-cholesterol (HDL-C) levels are risk factors for cardiovascular disease. Patients with primary adrenal insufficiency are at higher risk of cardiovascular complications compared with healthy subjects. However, there is no information on the relationship between adiponectin and glucocorticoid replacement therapy in patients with secondary adrenal insufficiency (SAI).
OBJECTIVE


To determine the effects of intrinsic adrenal function and glucocorticoid replacement therapy on serum adiponectin levels and lipid profile in patients with SAI.
DESIGN


Part 1: a cross-sectional study. Part 2: a randomized, double-blind, crossover study.
SETTING


Osaka University Hospital, Osaka, Japan.
PATIENTS


Part 1: 58 patients diagnosed with nonfunctioning pituitary adenoma who underwent insulin tolerance test (ITT) for assessment of adrenal function. Part 2: 12 SAI patients randomly received hydrocortisone replacement therapy at a dose of 10, 20, or 30 mg/d for 4 weeks per term for three terms.
OUTCOME MEASUREMENTS


Part 1: we analyzed the relationship between serum cortisol levels during ITT and serum adiponectin levels and the lipid profile. Part 2: serum adiponectin levels and lipid profile were measured every 4 weeks.
RESULTS


Serum levels of adiponectin and HDL-C correlated significantly with peak cortisol levels after ITT. Serum adiponectin and HDL-C levels were significantly lower in patients with SAI than non-SAI. Serum levels of adiponectin and HDL-C increased in a hydrocortisone dose-dependent manner.
CONCLUSIONS


Glucocorticoid replacement therapy increased serum levels of adiponectin, an adipose-derived anti-atherogenic factor, and HDL-C in patients with SAI.",2019,Serum adiponectin and HDL-C levels were significantly lower in patients with SAI than non-SAI.,"['patients with secondary adrenal insufficiency (SAI', 'Part 1: 58 patients diagnosed with non-functioning pituitary adenoma who underwent insulin tolerance test (ITT) for assessment of adrenal function', 'patients with SAI', 'patients with secondary adrenal insufficiency', 'Patients with primary adrenal insufficiency', 'Osaka University Hospital, Osaka, Japan']","['Glucocorticoid replacement therapy', 'Glucocorticoid replacement', 'hydrocortisone replacement therapy', 'glucocorticoid replacement therapy']","['cardiovascular complications', 'Serum levels of adiponectin and HDL-C', 'serum levels of adiponectin, an adipose-derived anti-atherogenic factor, and HDL-C', 'serum cortisol levels during ITT and serum adiponectin levels and lipid profile', 'Serum adiponectin and HDL-C levels', 'peak cortisol levels', 'serum adiponectin levels and HDL-C', 'serum adiponectin levels and lipid profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271738', 'cui_str': 'Secondary adrenocortical insufficiency'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032000', 'cui_str': 'Pituitary Adenoma'}, {'cui': 'C0236287', 'cui_str': 'Insulin tolerance test (procedure)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0001403', 'cui_str': 'Hypoadrenalisms, Primary'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",,0.0362271,Serum adiponectin and HDL-C levels were significantly lower in patients with SAI than non-SAI.,"[{'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Hayashi', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Tamada', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Murata', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Tetsuhiro', 'Initials': 'T', 'LastName': 'Kitamura', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Mukai', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Maeda', 'Affiliation': 'Department of Metabolism and Atherosclerosis, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Otsuki', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00420']
1237,31841078,Comparing the Effectiveness of Cognitive Functional Treatment and Lumbar Stabilization Treatment on Pain and Movement Control in Patients With Low Back Pain.,"BACKGROUND


The treatment of chronic low back pain (LBP) should target both behavioral variables and physical performance factors.
HYPOTHESIS


Cognitive functional treatment (CFT) and lumbar stabilization treatment (LST) will result in positive changes in pain and lumbar movement control (LMC) in patients with LBP.
STUDY DESIGN


Pretest-posttest intervention.
LEVEL OF EVIDENCE


Level 3.
METHODS


After screening, 52 participants (mean age, 44.3 ± 2.46 years) with chronic LBP were allocated into CFT (n = 17), LST (n = 17), or control (n = 18) groups. Pain and LMC were evaluated before and after 8 weeks of intervention with visual analog scale (VAS) and Luomajoki LMC battery tests, respectively.
RESULTS


Compared with baseline, pain and LMC were reduced and improved significantly in both groups after 8 weeks. However, the changes in both variables were not significantly different between groups. Percent change for pain between pretest and posttest values in the LST group was a decrease of 45% ( P  = 0.003), compared with a decrease of 40% ( P  = 0.003) in the CFT group. Change in LMC in the LST group was a decrease of 100% ( P  = 0.026), compared with a decrease of 200% ( P  = 0.018) in the CFT group. There as no change for both variables in the control group.
CONCLUSION


Both CFT and LST groups improved LMC scores and reduced pain intensity. However, there was no difference between the 2 experimental groups on pain and LMC test results.
CLINICAL RELEVANCE


In this study, intended to construct an intervention for people with chronic LBP, the primary aims were to help individuals ""make sense of their pain,"" develop effective pain control strategies via body relaxation and extinction of safety behaviors, and adopt healthy lifestyle behaviors to affect cognitive factors known to affect pain sensitivity and disability. These primary aims were achieved through an emphasis on factors such as development of positive beliefs, reduced fear, increased awareness, enhanced understanding and control of pain, adaptive coping, enhanced self-efficacy, confidence, and improved mood through the class-based intervention.",2020,"Change in LMC in the LST group was a decrease of 100% ( P  = 0.026), compared with a decrease of 200% ( P  = 0.018) in the CFT group.","['patients with LBP', 'people with chronic LBP', 'chronic low back pain (LBP', '52 participants (mean age, 44.3 ± 2.46 years) with chronic LBP', 'Patients With Low Back Pain']","['Cognitive functional treatment (CFT) and lumbar stabilization treatment (LST', 'LST', 'CFT', 'CFT and LST', 'Cognitive Functional Treatment and Lumbar Stabilization Treatment']","['Change in LMC', 'LMC scores and reduced pain intensity', 'pain and LMC', 'positive beliefs, reduced fear, increased awareness, enhanced understanding and control of pain, adaptive coping, enhanced self-efficacy, confidence, and improved mood', 'pain and LMC test results', 'Pain and Movement Control', 'pain sensitivity and disability', 'Pain and LMC', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C4508986', 'cui_str': 'Improved mood'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",52.0,0.0669959,"Change in LMC in the LST group was a decrease of 100% ( P  = 0.026), compared with a decrease of 200% ( P  = 0.018) in the CFT group.","[{'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Khodadad', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Biomechanics and Sport Injuries, Kharazmi University, Tehran, Republic of Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Biomechanics and Sport Injuries, Kharazmi University, Tehran, Republic of Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Hadadnezhad', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Biomechanics and Sport Injuries, Kharazmi University, Tehran, Republic of Iran.'}, {'ForeName': 'Sadredin', 'Initials': 'S', 'LastName': 'Shojaedin', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Biomechanics and Sport Injuries, Kharazmi University, Tehran, Republic of Iran.'}]",Sports health,['10.1177/1941738119886854']
1238,31317460,"Apneic Oxygenation During Prolonged Laryngoscopy in Obese Patients: a Randomized, Double-Blinded, Controlled Trial of Nasal Cannula Oxygen Administration.","BACKGROUND


Obese patients have a propensity to desaturate during induction of general anesthesia secondary to their reduced functional residual capacity and increased oxygen consumption. Apneic oxygenation can provide supplemental oxygen to the alveoli, even in the absence of ventilation, during attempts to secure the airway. In this study, we hypothesized that oxygen administration through a nasopharyngeal airway and standard nasal cannula during a simulated prolonged laryngoscopy would significantly prolong the safe apneic duration in obese patients.
METHODS


One hundred thirty-five obese patients undergoing non-emergent surgery requiring general anesthesia were randomized to either the control group or to receive apneic oxygenation with air versus oxygen. All patients underwent a standard intravenous induction. For patients randomized to receive apneic oxygenation, a nasopharyngeal airway and standard nasal cannula were inserted. A simulated prolonged laryngoscopy was performed to determine the duration of the safe apneic period, defined as the beginning of laryngoscopy until the peripheral oxygen saturation (SpO 2 ) reached 95%.
RESULTS


The oxygen group had a median safe apneic duration that was 103 s longer than the control group. The lowest mean SpO 2  value during the induction period was 3.8% higher in the oxygen group compared to the control group. Following intubation, patients in the oxygen group had a mean end tidal carbon dioxide (ETCO 2 ) level that was 3.0 mmHg higher than patients in the control group.
CONCLUSIONS


In obese patients, oxygen insufflation at 15 L/min through a nasopharyngeal airway and standard nasal cannula can significantly increase the safe apneic duration during induction of anesthesia.",2019,The lowest mean SpO 2  value during the induction period was 3.8% higher in the oxygen group compared to the control group.,"['Obese patients', 'Obese Patients', 'obese patients', 'One hundred thirty-five obese patients undergoing non-emergent surgery requiring general anesthesia']","['Nasal Cannula Oxygen Administration', 'apneic oxygenation, a nasopharyngeal airway and standard nasal cannula', 'control group or to receive apneic oxygenation with air versus oxygen']","['mean end tidal carbon dioxide (ETCO 2 ) level', 'Apneic Oxygenation', 'median safe apneic duration', 'safe apneic duration']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0475745', 'cui_str': 'Apneic oxygenation (procedure)'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0475745', 'cui_str': 'Apneic oxygenation (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",135.0,0.140261,The lowest mean SpO 2  value during the induction period was 3.8% higher in the oxygen group compared to the control group.,"[{'ForeName': 'Tiffany S', 'Initials': 'TS', 'LastName': 'Moon', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA. Tiffany.Moon@UTSouthwestern.edu.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Tai', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Kim', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Michael X', 'Initials': 'MX', 'LastName': 'Gonzales', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Lu', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Pak', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Katelynn', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Joy L', 'Initials': 'JL', 'LastName': 'Chen', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Abu T', 'Initials': 'AT', 'LastName': 'Minhajuddin', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Nwamaka', 'Initials': 'N', 'LastName': 'Nnamani', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Pamela E', 'Initials': 'PE', 'LastName': 'Fox', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}, {'ForeName': 'Babatunde', 'Initials': 'B', 'LastName': 'Ogunnaike', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, USA.'}]",Obesity surgery,['10.1007/s11695-019-04077-y']
1239,31303836,Effect of cervus and cucumis polypeptide combined with zoledronic acid on bone metabolic biochemical markers in glucocorticoids - Induced osteoporosis patients.,"Objective


To investigate the effect of cervus and cucumis polypeptide combined with zoledronic acid on bone metabolic biochemical markers in glucocorticoids - induced osteoporosis patients.
Methods


A total of 100 patients with glucocorticoids - induced osteoporosis admitted to our hospital from January 2015 to June 2017 were enrolled in this study. Patients were divided into observation group and control group by random number table method, 50 cases in each group. Patients in the observation group were treated with deer melon polypeptide in combination with zoledronic acid, and patients in the control group were treated with zoledronic acid alone. The patients in both groups were treated for 2 months. The changes of bone mineral density (BMD) and biochemical markers of bone metabolism in lumbar vertebrae L1-4, left femoral neck and large trochanter were analyzed before and after treatment.
Results


The pre- BMD at lumbar spine L 1-4 , left femoral neck and great trochanter had no statistic difference ( P  > 0.05), the BMD at each sites improved after treatment, and the difference were statistical before and after treatment ( P <  0.05). BMD at above sites of two groups after treatment had statistical difference ( P <  0.05), and the BMD at lumbar spine L 1-4 , left femoral neck and great trochanter in the observation group was higher than that of the control group. There were no significant differences in PTH, 25-(OH)D3, TRACP, β-CTX and BGP levels between the two groups before treatment (P > 0.05). The levels of 25-(OH)D3, TRACP, β-CTX and BGP in the two groups were significantly improved after treatment (P < 0.05), and the levels of PTH, TRACP and β-CTX in the observation group were significantly lower than those in the control group. The levels of 25-(OH) D3 and BGP were significantly higher than those of the control group (P < 0.05).
Conclusion


The cervus and cucumis polypeptide combined with zoledronic acid can improve the BMD at lumbar spine L 1-4 , left femoral neck and great trochanter, and ameliorate the bone metabolic biochemical markers for patients with glucocorticoids - induced osteoporosis.",2019,"There were no significant differences in PTH, 25-(OH)D3, TRACP, β-CTX and BGP levels between the two groups before treatment (P > 0.05).","['glucocorticoids - induced osteoporosis patients', 'patients with glucocorticoids - induced osteoporosis', '100 patients with glucocorticoids - induced osteoporosis admitted to our hospital from January 2015 to June 2017 were enrolled in this study', 'glucocorticoids - Induced osteoporosis patients']","['cucumis polypeptide combined with zoledronic acid', 'zoledronic acid alone', 'deer melon polypeptide in combination with zoledronic acid', 'zoledronic acid']","['levels of 25-(OH)D3, TRACP, β-CTX and BGP', 'BMD at lumbar spine L 1-4 , left femoral neck and great trochanter', 'PTH, 25-(OH)D3, TRACP, β-CTX and BGP levels', 'bone metabolic biochemical markers', 'BMD', 'bone mineral density (BMD) and biochemical markers of bone metabolism in lumbar vertebrae L1-4, left femoral neck and large trochanter', 'levels of 25-(OH) D3 and BGP', 'pre- BMD', 'levels of PTH, TRACP and β-CTX']","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0936045', 'cui_str': 'Cucumis'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0011133', 'cui_str': 'Deer'}, {'cui': 'C0440285', 'cui_str': 'Melons'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0297331', 'cui_str': 'TRAcP'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0673362', 'cui_str': 'L-1 (ester)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0223865', 'cui_str': 'Greater Trochanter'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1869108', 'cui_str': 'Biochemical markers of bone metabolism'}, {'cui': 'C0024091', 'cui_str': 'Lumbar Vertebrae'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0162370', 'cui_str': 'Trochanter'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",2017.0,0.0199574,"There were no significant differences in PTH, 25-(OH)D3, TRACP, β-CTX and BGP levels between the two groups before treatment (P > 0.05).","[{'ForeName': 'Dacheng', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Department of Trauma and Orthopaedics, Beijing LuHe Hospital Affiliated to Capital Medical University, Beijing 101149, China.'}, {'ForeName': 'Anhua', 'Initials': 'A', 'LastName': 'Long', 'Affiliation': 'Department of Trauma and Orthopaedics, Beijing LuHe Hospital Affiliated to Capital Medical University, Beijing 101149, China.'}, {'ForeName': 'Jialong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Trauma and Orthopaedics, Beijing LuHe Hospital Affiliated to Capital Medical University, Beijing 101149, China.'}, {'ForeName': 'Xuefei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Trauma and Orthopaedics, Beijing LuHe Hospital Affiliated to Capital Medical University, Beijing 101149, China.'}, {'ForeName': 'Yakui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Trauma and Orthopaedics, Beijing LuHe Hospital Affiliated to Capital Medical University, Beijing 101149, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2019.04.010']
1240,30887824,An initial randomized controlled trial of behavioral activation for treatment of concurrent crystal methamphetamine dependence and sexual risk for HIV acquisition among men who have sex with men.,"Men who have sex with men (MSM) continue to be the largest risk group for HIV infections in the U.S., where crystal methamphetamine abuse heightens risk for HIV infection through greater engagement in condomless anal sex (CAS). Existing treatments lack attention to replacement activities or the role of depressed mood. Behavioral activation (BA) is an evidence-based approach for depression that involves identifying and participating in pleasurable, goal-directed activities. We hypothesize, for MSM abusing crystal methamphetamine, re-learning how to engage in non-drug-using aspects of life would facilitate their ability to benefit from sexual risk reduction (SRR) counseling. Project IMPACT was a pilot randomized-controlled-trial. Forty-six MSM at sexual risk of acquiring HIV who met DSM-IV criteria for crystal methamphetamine dependence were enrolled. Of those MSM, 41 were randomized: 21 were assigned to the intervention, two sessions of SRR, ten sessions of BA with SRR, and one session of relapse prevention; 20 participants were assigned to a control condition (two sessions of SRR). At the acute post-intervention visit, intervention participants reported an average of 3.2 CAS acts with men who were HIV-infected or whose status they did not know, compared to 4.5 among control participants ( β  = -0.36; 95% CI: -0.69, -0.02;  p  = 0.035). At the 6-month post-intervention visit, intervention participants reported 1.1 CAS acts with men who were HIV-infected or whose status they did not know compared to 2.8 among control participants ( β  = -0.95; 95% CI: -1.44, -0.46;  p  < 0.0001). Similarly, intervention participants reported 1.0 CAS acts under the influence of crystal methamphetamine with men who were HIV-infected or whose status they did not know compared to 2.5 among control participants ( β  = -0.87; 95% CI: -1.38, -0.36;  p  = 0.0005). Lastly, intervention participants reported more continuous days abstaining from crystal methamphetamine compared to control (50.1 vs. 39.0, respectively) ( β  = 0.25; 95% CI: 0.16, 0.34;  p  < 0.0001). Findings are encouraging, provide evidence of feasibility and acceptability, and demonstrate initial efficacy for reducing sexual risk for HIV and crystal methamphetamine use.",2019,"Findings are encouraging, provide evidence of feasibility and acceptability, and demonstrate initial efficacy for reducing sexual risk for HIV and crystal methamphetamine use.","['Forty-six MSM at sexual risk of acquiring HIV who met DSM-IV criteria for crystal methamphetamine dependence were enrolled', 'Men who have sex with men (MSM', 'men who have sex with men']","['Behavioral activation (BA', 'crystal methamphetamine', 'behavioral activation']",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0427896', 'cui_str': 'Crystal - human material (substance)'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence (disorder)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0427896', 'cui_str': 'Crystal - human material (substance)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}]",[],46.0,0.0937053,"Findings are encouraging, provide evidence of feasibility and acceptability, and demonstrate initial efficacy for reducing sexual risk for HIV and crystal methamphetamine use.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Mimiaga', 'Affiliation': 'a Center for Health Equity Research , Brown University , Providence , RI , USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Pantalone', 'Affiliation': 'd The Fenway Institute , Fenway Health , Boston , MA , USA.'}, {'ForeName': 'Katie B', 'Initials': 'KB', 'LastName': 'Biello', 'Affiliation': 'a Center for Health Equity Research , Brown University , Providence , RI , USA.'}, {'ForeName': 'Jackie M White', 'Initials': 'JMW', 'LastName': 'Hughto', 'Affiliation': 'd The Fenway Institute , Fenway Health , Boston , MA , USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Frank', 'Affiliation': 'a Center for Health Equity Research , Brown University , Providence , RI , USA.'}, {'ForeName': 'Conall', 'Initials': 'C', 'LastName': ""O'Cleirigh"", 'Affiliation': 'd The Fenway Institute , Fenway Health , Boston , MA , USA.'}, {'ForeName': 'Sari L', 'Initials': 'SL', 'LastName': 'Reisner', 'Affiliation': 'd The Fenway Institute , Fenway Health , Boston , MA , USA.'}, {'ForeName': 'Arjee', 'Initials': 'A', 'LastName': 'Restar', 'Affiliation': 'a Center for Health Equity Research , Brown University , Providence , RI , USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Mayer', 'Affiliation': 'd The Fenway Institute , Fenway Health , Boston , MA , USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'd The Fenway Institute , Fenway Health , Boston , MA , USA.'}]",AIDS care,['10.1080/09540121.2019.1595518']
1241,31295069,Dynamics of the power-duration relationship during prolonged endurance exercise and influence of carbohydrate ingestion.,"We tested the hypotheses that the parameters of the power-duration relationship, estimated as the end-test power (EP) and work done above EP (WEP) during a 3-min all-out exercise test (3MT), would be reduced progressively after 40 min, 80 min, and 2 h of heavy-intensity cycling and that carbohydrate (CHO) ingestion would attenuate the reduction in EP and WEP. Sixteen participants completed a 3MT without prior exercise (control), immediately after 40 min, 80 min, and 2 h of heavy-intensity exercise while consuming a placebo beverage, and also after 2 h of heavy-intensity exercise while consuming a CHO supplement (60 g/h CHO). There was no difference in EP measured without prior exercise (260 ± 37 W) compared with EP after 40 min (268 ± 39 W) or 80 min (260 ± 40 W) of heavy-intensity exercise; however, after 2 h EP was 9% lower compared with control (236 ± 47 W;  P  < 0.05). There was no difference in WEP measured without prior exercise (17.9 ± 3.3 kJ) compared with after 40 min of heavy-intensity exercise (16.1 ± 3.3 kJ), but WEP was lower ( P  < 0.05) than control after 80 min (14.7 ± 2.9 kJ) and 2 h (13.8 ± 2.7 kJ). Compared with placebo, CHO ingestion negated the reduction of EP following 2 h of heavy-intensity exercise (254 ± 49 W) but had no effect on WEP (13.5 ± 3.4 kJ). These results reveal a different time course for the deterioration of EP and WEP during prolonged endurance exercise and indicate that EP is sensitive to CHO availability. NEW & NOTEWORTHY  The parameters of the power-duration relationship [critical power (CP) and the curvature constant (W')] have typically been considered to be static. Here we report the time course for reductions in CP and W', as estimated with the 3-min all-out cycle test, during 2 h of heavy-intensity exercise. We also show that carbohydrate ingestion during exercise preserves CP, but not W', without altering muscle glycogen depletion. These results provide new mechanistic and practical insight into the power-duration curve and its relationship to exercise-related fatigue development.",2019,"Compared to placebo, CHO ingestion negated the reduction of EP following 2-h of heavy-intensity exercise (254 ± 49 W) but had no effect on WEP (13.5 ± 3.4 kJ).",['Sixteen participants completed a'],"['3MT without prior exercise (control), immediately after 40 min, 80 min and 2-h of heavy-intensity exercise while consuming a placebo beverage, and also after 2-h of heavy-intensity exercise while consuming a CHO supplement', 'carbohydrate ingestion', 'placebo, CHO ingestion']","['reduction of EP', 'EP', 'WEP']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",16.0,0.0280821,"Compared to placebo, CHO ingestion negated the reduction of EP following 2-h of heavy-intensity exercise (254 ± 49 W) but had no effect on WEP (13.5 ± 3.4 kJ).","[{'ForeName': 'Ida E', 'Initials': 'IE', 'LastName': 'Clark', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Vanhatalo', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Joseph', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Matthew I', 'Initials': 'MI', 'LastName': 'Black', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Blackwell', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Lee J', 'Initials': 'LJ', 'LastName': 'Wylie', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Tan', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bailey', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Brad W', 'Initials': 'BW', 'LastName': 'Wilkins', 'Affiliation': 'Nike Sport Research Lab, Beaverton, Oregon.'}, {'ForeName': 'Brett S', 'Initials': 'BS', 'LastName': 'Kirby', 'Affiliation': 'Nike Sport Research Lab, Beaverton, Oregon.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Jones', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00207.2019']
1242,31269419,Neurophysiological evidences of the transient effects of mindfulness induction on emotional processing in children: An ERP study.,"Mindfulness has been shown to improve mental health through adaptive responses during emotional processing. Although the benefits of mindfulness and the corresponding neural correlates have been demonstrated in adults, little is known about the impact of mindfulness on pre-adolescent children. The present study examined the influence of mindfulness induction on electrocortical responses during emotional processing in pre-adolescent children. Electroencephalograms were recorded from 35 pre-adolescent children; 18 children (M age  = 10.44 years) were randomly assigned to a mindfulness induction group and 17 children were randomly assigned to a control group (M age  = 9.88 years). Group differences in event-related brain potentials (ERPs) associated with the processing of positive, negative and neutral stimuli were analysed. The P1, N2 and late positive potentials (LPPs) were compared between the mindfulness induction group and the control group. The amplitude of the P1 was smaller in the mindfulness induction group compared to the control group under both the negative and neutral conditions. For both groups, the amplitude of the N2 was larger during the presentation of negative stimuli compared to both positive and neutral stimuli. Additionally, the LPP 600-1000 and LPP 1000-1500 were smaller in the mindfulness induction group than in the control group. The presented findings suggest that the impacts of mindfulness during emotional processing are reflected by both bottom-up (evidenced by the early ERP components) and top-down (evidenced by the later ERP components) processes. These results indicate that mindfulness modulates emotional responses in pre-adolescent children and thus has important implications in training and clinical practices.",2019,The amplitude of the P1 was smaller in the mindfulness induction group compared to the control group under both the negative and neutral conditions.,"['children', '35 pre-adolescent children; 18 children (M age \u202f=\u202f10.44\u202fyears', 'pre-adolescent children', 'group and 17 children']",['mindfulness induction'],"['event-related brain potentials (ERPs', 'emotional responses', 'electrocortical responses', 'emotional processing', 'processing of positive, negative and neutral stimuli', 'P1, N2 and late positive potentials (LPPs', 'amplitude of the P1']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}]",,0.0160937,The amplitude of the P1 was smaller in the mindfulness induction group compared to the control group under both the negative and neutral conditions.,"[{'ForeName': 'Xinmei', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'College of Psychology, Shenzhen University, Shenzhen, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, China.'}, {'ForeName': 'Jieting', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'College of Psychology, Shenzhen University, Shenzhen, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, China. Electronic address: jennyzhang@szu.edu.cn.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'College of Psychology, Shenzhen University, Shenzhen, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, China.'}, {'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': ""The Center for Bao'an District Education Development Affairs, Shenzhen, China.""}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.06.014']
1243,29806112,Does a tailored guideline implementation strategy have an impact on clinical physiotherapy practice? A nonrandomized controlled study.,"RATIONALE, AIMS, AND OBJECTIVES


Clinical practice guidelines are a common strategy for implementing research findings into practice and facilitating evidence-based practice in health care settings. There is a paucity of knowledge about the impact of different guideline implementation strategies on clinical practice in a physiotherapy context. The study aimed to assess the impact of a guideline implementation intervention on clinical physiotherapy practice.
METHODS


A tailored, multicomponent guideline implementation was compared with usual practice. Clinical practice was evaluated in physiotherapy treatment methods used for 3 common musculoskeletal disorders. Data were collected with a validated web-based questionnaire.
RESULTS


Postimplementation data were collected from 168 physiotherapists in the intervention group and 88 in the control group. The most frequently reported treatment methods for low back pain were advice on posture (reported by 95% in the intervention group vs 90% in the control group), advice to stay active (93% vs 90%), and stabilization exercise (88% vs 80%). Differences between groups were not significant. Reported use of body awareness training (23% vs 6%, P = .023) and spinal manipulation (9% vs 23%, P = .044) differed between the groups. The most frequently used treatment methods for neck pain were advice on posture (95% vs 92%), advice to stay active (89% vs 87%), and ROM exercise (85% vs 71%) (no significant differences between groups). Reported use of body awareness training (24% vs 7%, P = .023) differed between the groups. The most frequently used treatment methods for subacromial pain were range of motion exercises (reported by 93% in both groups), advice on posture (90% vs 87%), home exercise (77% vs 74%), and stabilization exercise (69% vs 66%) (no significant difference between groups).
CONCLUSIONS


Treatment methods used were largely in line with evidence already before the guideline implementation, which may explain why the guideline implementation had only little impact on clinical practice.",2019,"Reported use of body awareness training (24% vs 7%, P = .023) differed between the groups.",['168 physiotherapists in the intervention group and 88 in the control group'],['guideline implementation intervention'],"['home exercise', 'spinal manipulation', 'subacromial pain', 'body awareness training', 'stabilization exercise', 'advice on posture', 'low back pain', 'ROM exercise', 'advice to stay active']","[{'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]",,0.06763,"Reported use of body awareness training (24% vs 7%, P = .023) differed between the groups.","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Bernhardsson', 'Affiliation': 'Närhälsan Research and Development Primary Health Care, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Maria E H', 'Initials': 'MEH', 'LastName': 'Larsson', 'Affiliation': 'Närhälsan Research and Development Primary Health Care, Region Västra Götaland, Gothenburg, Sweden.'}]",Journal of evaluation in clinical practice,['10.1111/jep.12958']
1244,29514030,Tenofovir versus Placebo to Prevent Perinatal Transmission of Hepatitis B.,"BACKGROUND


Pregnant women with an elevated viral load of hepatitis B virus (HBV) have a risk of transmitting infection to their infants, despite the infants' receiving hepatitis B immune globulin.
METHODS


In this multicenter, double-blind clinical trial performed in Thailand, we randomly assigned hepatitis B e antigen (HBeAg)-positive pregnant women with an alanine aminotransferase level of 60 IU or less per liter to receive tenofovir disoproxil fumarate (TDF) or placebo from 28 weeks of gestation to 2 months post partum. Infants received hepatitis B immune globulin at birth and hepatitis B vaccine at birth and at 1, 2, 4, and 6 months. The primary end point was a hepatitis B surface antigen (HBsAg)-positive status in the infant, confirmed by the HBV DNA level at 6 months of age. We calculated that a sample of 328 women would provide the trial with 90% power to detect a difference of at least 9 percentage points in the transmission rate (expected rate, 3% in the TDF group vs. 12% in the placebo group).
RESULTS


From January 2013 to August 2015, we enrolled 331 women; 168 women were randomly assigned to the TDF group and 163 to the placebo group. At enrollment, the median gestational age was 28.3 weeks, and the median HBV DNA level was 8.0 log 10  IU per milliliter. Among 322 deliveries (97% of the participants), there were 319 singleton births, two twin pairs, and one stillborn infant. The median time from birth to administration of hepatitis B immune globulin was 1.3 hours, and the median time from birth to administration of hepatitis B vaccine was 1.2 hours. In the primary analysis, none of the 147 infants (0%; 95% confidence interval [CI], 0 to 2) in the TDF group were infected, as compared with 3 of 147 (2%; 95% CI, 0 to 6) in the placebo group (P=0.12). The rate of adverse events did not differ significantly between groups. The incidence of a maternal alanine aminotransferase level of more than 300 IU per liter after discontinuation of the trial regimen was 6% in the TDF group and 3% in the placebo group (P=0.29).
CONCLUSIONS


In a setting in which the rate of mother-to-child HBV transmission was low with the administration of hepatitis B immune globulin and hepatitis B vaccine in infants born to HBeAg-positive mothers, the additional maternal use of TDF did not result in a significantly lower rate of transmission. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT01745822 .).",2018,The rate of adverse events did not differ significantly between groups.,"['322 deliveries (97% of the participants), there were 319 singleton births, two twin pairs, and one stillborn infant', 'Pregnant women with an elevated viral load of hepatitis B virus (HBV', 'HBeAg)-positive pregnant women with an', 'infants born to HBeAg-positive mothers', '328 women', 'From January 2013 to August 2015, we enrolled 331 women; 168 women']","['placebo', 'alanine aminotransferase level of 60 IU or less per liter to receive tenofovir disoproxil fumarate (TDF) or placebo', 'TDF', 'hepatitis B immune globulin', 'Tenofovir versus Placebo']","['hepatitis B surface antigen (HBsAg)-positive status in the infant, confirmed by the HBV DNA level', 'rate of transmission', 'incidence of a maternal alanine aminotransferase level', 'Perinatal Transmission of Hepatitis B', 'rate of adverse events', 'median HBV DNA level', 'transmission rate', 'median time from birth to administration of hepatitis B immune globulin']","[{'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0062525', 'cui_str': 'hepatitis B immunoglobin'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}]","[{'cui': 'C0149709', 'cui_str': 'HBsAg positive'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0062525', 'cui_str': 'hepatitis B immunoglobin'}]",331.0,0.680345,The rate of adverse events did not differ significantly between groups.,"[{'ForeName': 'Gonzague', 'Initials': 'G', 'LastName': 'Jourdain', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ngo-Giang-Huong', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Harrison', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Decker', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Woottichai', 'Initials': 'W', 'LastName': 'Khamduang', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Camlin', 'Initials': 'C', 'LastName': 'Tierney', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Salvadori', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Tim R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Wasna', 'Initials': 'W', 'LastName': 'Sirirungsi', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Jullapong', 'Initials': 'J', 'LastName': 'Achalapong', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Prapap', 'Initials': 'P', 'LastName': 'Yuthavisuthi', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Prateep', 'Initials': 'P', 'LastName': 'Kanjanavikai', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Orada P', 'Initials': 'OP', 'LastName': 'Na Ayudhaya', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Thitiporn', 'Initials': 'T', 'LastName': 'Siriwachirachai', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Sinart', 'Initials': 'S', 'LastName': 'Prommas', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Prapan', 'Initials': 'P', 'LastName': 'Sabsanong', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Aram', 'Initials': 'A', 'LastName': 'Limtrakul', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Supang', 'Initials': 'S', 'LastName': 'Varadisai', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Chaiwat', 'Initials': 'C', 'LastName': 'Putiyanun', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Pornnapa', 'Initials': 'P', 'LastName': 'Suriyachai', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Prateung', 'Initials': 'P', 'LastName': 'Liampongsabuddhi', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Suraphan', 'Initials': 'S', 'LastName': 'Sangsawang', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Wanmanee', 'Initials': 'W', 'LastName': 'Matanasarawut', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Sudanee', 'Initials': 'S', 'LastName': 'Buranabanjasatean', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Pichit', 'Initials': 'P', 'LastName': 'Puernngooluerm', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Chureeratana', 'Initials': 'C', 'LastName': 'Bowonwatanuwong', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Virat', 'Initials': 'V', 'LastName': 'Klinbuayaem', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Satawat', 'Initials': 'S', 'LastName': 'Thongsawat', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Sombat', 'Initials': 'S', 'LastName': 'Thanprasertsuk', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Siberry', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Diane H', 'Initials': 'DH', 'LastName': 'Watts', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Trudy V', 'Initials': 'TV', 'LastName': 'Murphy', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Noele P', 'Initials': 'NP', 'LastName': 'Nelson', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Chung', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Pol', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}, {'ForeName': 'Nantasak', 'Initials': 'N', 'LastName': 'Chotivanich', 'Affiliation': 'From the Institut de Recherche pour le Développement Unité Mixte Internationale 174-Program for Health, Prevention, and Treatment (PHPT) (G.J., N.N.-G.-H., L.D., N.S., T.R.C.), the Faculty of Associated Medical Sciences, Chiang Mai University (G.J., N.N.-G.-H., L.D., W.K., N.S., T.R.C., W.S.), Nakornping Hospital (A.L.), Health Promotion Center Region 1 (S.S.), the Medical Department, Sanpatong Hospital (V.K.), and the Department of Internal Medicine, Faculty of Medicine, Chiang Mai University (S. Thongsawat), Chiang Mai, the Obstetrics and Gynecology Department, Chiangrai Prachanukroh Hospital (J.A.), and Mae Chan Hospital (S.B.), Chiang Rai, Prapokklao Hospital, Chantaburi (P.Y.), Banglamung Hospital (P.K.) and Chonburi Hospital (C.B., N. Chotivanich), Chonburi, Nopparat Rajathanee Hospital (O.P.N.A.), Bhumibol Adulyadej Hospital (S. Prommas), and the Faculty of Medicine, Chulalongkorn University (T.P.), Bangkok, Khon Kaen Hospital, Khon Kaen (T.S.), Samutprakarn Hospital, Samutprakarn (P. Sabsanong), Samutsakhon Hospital, Samutsakorn (S.V.), Chiang Kham Hospital (C.P.) and Phayao Hospital (P. Suriyachai), Phayao, Lampang Hospital, Lampang (P.L.), Lamphun Hospital, Lamphun (W.M.), Maharaj Nakornratchasrima Hospital, Nakornratchasrima (P.P.), and the Department of Disease Control, Ministry of Public Health, Nonthaburi (S. Thanprasertsuk) - all in Thailand; the Department of Immunology and Infectious Diseases (G.J., N.N.-G.-H., T.R.C.) and the Center for Biostatistics in AIDS Research (L.H., C.T.), Harvard T.H. Chan School of Public Health, and the Gastrointestinal Unit, Massachusetts General Hospital (R.T.C.) - both in Boston; the Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom (T.R.C.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (G.K.S., N. Chakhtoura); the Office of the Global AIDS Coordinator, Department of State, Washington, DC (D.H.W.); the Centers for Disease Control and Prevention, Atlanta (T.V.M., N.P.N.); and Université Paris Descartes, INSERM Unité 1223, Institut Pasteur, the Department of Hepato-Gastroenterology, Cochin University Hospital, Paris (S. Pol).'}]",The New England journal of medicine,['10.1056/NEJMoa1708131']
1245,31286497,The Roles of Group Status and Group Membership in the Practice of Hypodescent.,"Hypodescent emerged in U.S. history to reinforce racial hierarchy. Research suggests that among contemporary U.S. adults, hypodescent continues to shape social perception. Among U.S. children, however, hypodescent is less likely to be endorsed. Here, we tested for hypodescent by introducing U.S. children (ages 4-9) and adults (N = 273) to hierarchically ordered novel groups (one was high status and another was low status) and then to a child who had one parent from each group. In Study 1, we presented the groups in a third-party context. In Study 2, we randomly assigned participants to the high-status or the low-status group. Across both studies, participants did not reliably endorse hypodescent, raising questions as to what elicits this practice.",2020,"Across both studies, participants did not reliably endorse hypodescent, raising questions as to what elicits this practice.",['hypodescent by introducing U.S. children (ages 4-9) and adults (N\xa0=\xa0273) to hierarchically ordered novel groups (one was high status and another was low status) and then to a child who had one parent from each group'],[],[],"[{'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",[],[],,0.0263571,"Across both studies, participants did not reliably endorse hypodescent, raising questions as to what elicits this practice.","[{'ForeName': 'Steven O', 'Initials': 'SO', 'LastName': 'Roberts', 'Affiliation': 'Stanford University.'}, {'ForeName': 'Arnold K', 'Initials': 'AK', 'LastName': 'Ho', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Gülgöz', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Berka', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Gelman', 'Affiliation': 'University of Michigan.'}]",Child development,['10.1111/cdev.13279']
1246,31286397,The Effect of Intraoperative Dexmedetomidine Versus Morphine on Postoperative Morphine Requirements After Laparoscopic Bariatric Surgery.,"BACKGROUND


Dexmedetomidine is an α 2  receptor agonist with sedative and analgesic properties. During bariatric surgery, its use may reduce postoperative opioid requirements, reduce their side effects, and improve quality of recovery. The aim of this prospective randomized controlled trial was to compare the effect of dexmedetomidine bolus and infusion versus morphine bolus given prior to the end of laparoscopic bariatric surgery.
METHODS


Sixty morbidly obese patients (BMI > 40 kg m -2 ) aged 18 to 60 years, undergoing laparoscopic sleeve gastrectomy, received morphine sulfate (bolus 0.08 mg kg -1  followed by a saline infusion) (group M, n = 30) or dexmedetomidine (loading dose of 1 μg kg -1  followed by 0.5 μg kg -1  h -1 ) (group D, n = 30) 30 min before the end of surgery. Data collected included morphine consumption in the post-anesthesia care unit (PACU) (primary outcome) and at 24 h, pain intensity, nausea, heart rate, blood pressure, vomiting, sedation, and quality of recovery.
RESULTS


There was no significant difference in morphine consumption in the PACU (group D 12.2 ± 5.44 mg, group M 13.28 ± 6.64 mg, P = 0.54) or at 24 h (group D 40.67 ± 24.78 mg, group M 43.28 ± 27.79 mg, P = 0.75); when accounting for intraoperative morphine given group M had significantly higher morphine consumption when compared to group D (23.48 ± 6.22 mg vs. 12.22 ± 5.54 mg, respectively, P < 0.01). Group D patients had more cardiovascular stability.
CONCLUSIONS


Dexmedetomidine given prior to end of laparoscopic sleeve gastrectomy provides the same level of postoperative analgesia as morphine with better hemodynamic profile.",2019,"There was no significant difference in morphine consumption in the PACU (group D 12.2 ± 5.44 mg, group M 13.28 ± 6.64 mg, P = 0.54) or at 24 h (group D 40.67 ± 24.78 mg, group M 43.28 ± 27.79 mg, P = 0.75); when accounting for intraoperative morphine given group M had significantly higher morphine consumption when compared to group D (23.48 ± 6.22 mg vs. 12.22 ± 5.54 mg, respectively, P < 0.01).","['aged 18 to 60\xa0years, undergoing', 'Sixty morbidly obese patients (BMI\u2009>\u200940\xa0kg']","['Laparoscopic Bariatric Surgery', 'Dexmedetomidine', 'morphine sulfate (bolus 0.08', 'dexmedetomidine (loading dose of 1\xa0μg\xa0kg -1  followed by 0.5\xa0μg', 'PACU', 'laparoscopic sleeve gastrectomy', 'Intraoperative Dexmedetomidine Versus Morphine', 'dexmedetomidine bolus and infusion versus morphine']","['Postoperative Morphine Requirements', 'morphine consumption', '24\xa0h, pain intensity, nausea, heart rate, blood pressure, vomiting, sedation, and quality of recovery', 'cardiovascular stability']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0066814', 'cui_str': 'Morphine Sulfate'}, {'cui': 'C4517417', 'cui_str': 'Zero point zero eight'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",60.0,0.402263,"There was no significant difference in morphine consumption in the PACU (group D 12.2 ± 5.44 mg, group M 13.28 ± 6.64 mg, P = 0.54) or at 24 h (group D 40.67 ± 24.78 mg, group M 43.28 ± 27.79 mg, P = 0.75); when accounting for intraoperative morphine given group M had significantly higher morphine consumption when compared to group D (23.48 ± 6.22 mg vs. 12.22 ± 5.54 mg, respectively, P < 0.01).","[{'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Zeeni', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Aouad', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Dayane', 'Initials': 'D', 'LastName': 'Daou', 'Affiliation': 'Keserwan Medical Center, Keserwan, Jounieh, Lebanon.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Naji', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Jabbour-Khoury', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ramzi S', 'Initials': 'RS', 'LastName': 'Alami', 'Affiliation': 'Department of Surgery, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Bassem Y', 'Initials': 'BY', 'LastName': 'Safadi', 'Affiliation': 'Department of Surgery, Lebanese American University, Beirut, Lebanon.'}, {'ForeName': 'Sahar M', 'Initials': 'SM', 'LastName': 'Siddik-Sayyid', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon. ss01@aub.edu.lb.'}]",Obesity surgery,['10.1007/s11695-019-04074-1']
1247,31285062,Randomized controlled trial of a well-being intervention in cardiac patients.,"OBJECTIVE


Positive psychological well-being interventions have demonstrated promise in improving both psychological and physical health-related outcomes in patients with coronary artery disease (CAD), but evidence of the efficacy of these interventions with individuals with CAD is limited. As such, we developed an eight-week group-based intervention targeting eudaimonic aspects of psychological well-being in a randomized pilot trial. The primary aims of the trial were feasibility and acceptability, and we also explored the intervention's effectiveness on psychological outcomes.
METHOD


Participants were 40 CAD outpatients randomly assigned to the intervention (n = 20) or an attention-matched control group (n = 20). Feasibility was measured by rates of group session attendance and homework completion, and acceptability was assessed through participant ratings of intervention activities. Additional study outcomes, compared between groups, included psychological well-being, optimism, depression, and positive and negative affect.
RESULTS


The intervention met a priori criteria for feasibility and acceptability. The intervention was also associated with greater improvements in psychological well-being (β = -16.90; 95% Confidence Interval [CI] = -23.36, -10.44; p < .001, ES = 1.65), optimism (β = -8.80; 95% CI = -11.17, -6.43; t = -7.41; p < .001; ES = 2.34), and depression (β = 26.45; 95% CI = 20.97, 31.93; p < .001) immediately post-intervention, with sustained effects six weeks later.
CONCLUSIONS


These results indicate that the intervention was feasible, well-accepted, and effective in improving clinically relevant psychological outcomes in individuals with CAD. Future work should seek to replicate this work and assess general health-related and cardiac health-specific outcomes.",2019,"The intervention was also associated with greater improvements in psychological well-being (β = -16.90; 95% Confidence Interval [CI] = -23.36, -10.44; p < .001, ES = 1.65), optimism (β = -8.80; 95% CI = -11.17, -6.43; t = -7.41; p < .001; ES = 2.34), and depression (β = 26.45; 95% CI = 20.97, 31.93; p < .001) immediately post-intervention, with sustained effects six weeks later.
","['cardiac patients', 'individuals with CAD', 'Participants were 40 CAD outpatients randomly assigned to the intervention (n\u202f=\u202f20) or an', 'patients with coronary artery disease (CAD']",['attention-matched control group'],"['psychological well-being, optimism, depression, and positive and negative affect', 'rates of group session attendance and homework completion, and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0589414', 'cui_str': 'Homework, function (observable entity)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",40.0,0.126852,"The intervention was also associated with greater improvements in psychological well-being (β = -16.90; 95% Confidence Interval [CI] = -23.36, -10.44; p < .001, ES = 1.65), optimism (β = -8.80; 95% CI = -11.17, -6.43; t = -7.41; p < .001; ES = 2.34), and depression (β = 26.45; 95% CI = 20.97, 31.93; p < .001) immediately post-intervention, with sustained effects six weeks later.
","[{'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Nikrahan', 'Affiliation': 'Department of Psychology, Farhangian University, Tehran, Iran; Department of Psychology, University of Isfahan, Isfahan, Iran. Electronic address: rezanikrahan@yahoo.com.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Eshaghi', 'Affiliation': 'Department of Psychology, Boroujen Branch, Islamic Azad University, Boroujen, Iran.'}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Massey', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA. Electronic address: cmassey1@mgh.harvard.edu.'}, {'ForeName': 'Aazam', 'Initials': 'A', 'LastName': 'Hemmat', 'Affiliation': 'Sahib al-Zaman Hospital, Sahib al-Zaman Street, Shahreza City, Isfahan Province, Iran.'}, {'ForeName': 'Hermioni L', 'Initials': 'HL', 'LastName': 'Amonoo', 'Affiliation': ""Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA; Brigham and Women's Hospital, 1153 Centre Street, Boston, MA 02130, USA; Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215, USA. Electronic address: hermionie_lokko@dfci.harvard.edu.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Healy', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA; Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA. Electronic address: bchealy@mgh.harvard.edu.'}, {'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA. Electronic address: jhuffman@mgh.harvard.edu.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2019.06.005']
1248,31839852,"Feasibility, Acceptability, and Preliminary Efficacy of a Recess-Based Fitness Intervention in Elementary School Children.","Although fitness may benefit cognition in youth, most attention has been given to cardiorespiratory fitness despite the health benefits of muscular fitness. Few studies have examined interventions that incorporate both cardiorespiratory and muscular fitness or have been offered during school recess. Furthermore, most fitness intervention studies examining cognitive outcomes have not reported on implementation information. The purpose of this pilot study was to examine the feasibility, acceptability, and preliminary efficacy on fitness and cognition of a recess intervention in elementary school children. Two schools were randomized to either a 3-month cardiorespiratory and muscular fitness intervention (15 minutes/weekday during recess) or control condition (standard recess activities). Process evaluation (feasibility and acceptability) measures were recorded daily (research staff questionnaire), weekly (accelerometer and heart rate monitors), and post-intervention (participant and school-staff questionnaires). Preliminary efficacy measures included pre- and post-intervention inhibition/attention, working memory, and cardiorespiratory and muscular fitness scores. Some feasibility and acceptability measures were favorable (88% of the lessons were implemented, 78% of the lessons were implemented as planned, and the majority of students and school staff were satisfied with most aspects of the intervention). However, intensity adherence during the intervention sessions based on accelerometry (% of time spent in moderate-to-vigorous activity: 41.7 ± 14.5) and participation (19.4% attendance rate) were lower than expected. Preliminary efficacy of the intervention on cognitive and fitness outcomes was not demonstrated. This study provided evidence that some aspects of the fitness intervention were acceptable during school recess. However, important implementation factors (i.e., intervention exposure) should be targeted to improve youth fitness programs offered during this school setting.",2019,Preliminary efficacy of the intervention on cognitive and fitness outcomes was not demonstrated.,"['elementary school children', 'Elementary School Children']","['3-month cardiorespiratory and muscular fitness intervention (15 minutes/weekday during recess) or control condition (standard recess activities', 'Recess-Based Fitness Intervention']","['daily (research staff questionnaire), weekly (accelerometer and heart rate monitors), and post-intervention (participant and school-staff questionnaires', 'intensity adherence', 'pre- and post-intervention inhibition/attention, working memory, and cardiorespiratory and muscular fitness scores', 'cognitive and fitness outcomes', 'Feasibility, Acceptability']","[{'cui': 'C0260267', 'cui_str': 'School child (occupation)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0174286,Preliminary efficacy of the intervention on cognitive and fitness outcomes was not demonstrated.,"[{'ForeName': 'Christine W', 'Initials': 'CW', 'LastName': 'St Laurent', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts-Amherst, Amherst, MA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Burkart', 'Affiliation': 'Department of Exercise Science, University of South Carolina, SC, USA.'}, {'ForeName': 'Sofiya', 'Initials': 'S', 'LastName': 'Alhassan', 'Affiliation': 'Department of Kinesiology, University of Massachusetts-Amherst, Amherst, MA, USA.'}]",International journal of exercise science,[]
1249,31283096,Intermittent pneumatic compression in patients with ESRD. A systematic review.,"INTRODUCTION


Patients with end-stage renal disease (ESRD) experience frequent hemodialysis (HD) complications. Intradialytic hypotension (IDH) is a common complication presenting in approximately between 20 and 50% of HD sessions. Available interventions such as volume replacement or vasoactive medications are associated with significant side effects. Intermittent pneumatic compression (IPC) has been proposed as a feasible intervention for the prevention of IDH, treatment of peripheral arterial disease and venous ulcers. These devices apply intermittent pressure to the legs improving arterial blood flow, mobilization of pooled blood with an increase in venous return increasing the effective circulatory volume. Our goal was to identify the published clinical evidence on whether IPC has a circulatory benefit and is it well-tolerated among patients receiving HD.
METHODS


We conducted a systematic review to identify studies assessing the efficacy and safety of IPC in patients with ESRD. Our primary outcome was IDH. Secondary outcomes such as HD comfort, ultrafiltration volume, and physical activity were collected. No restrictions where used and we included all observational and interventional studies. Two reviewers performed screening and study quality assessment.
FINDINGS


We included seven studies. Out of the seven studies, five addressed IDH, and the rest were included for secondary outcomes such as physical capacity and HD comfort. In one randomized crossover trial comparing exercise against IPC, 21 patients were randomized to 3 different arms (no intervention, cycling, IPC) a decrease in the rates of IDH with IPC was described (43%, 38%, and 24% respectively P = 0.014). The smaller studies corroborated these results. All studies where at high risk of bias.
DISCUSSION


IPC might offer significant benefits for patients undergoing HD not limited to prevention of IDH but also improvement of hemodialysis comfort and physical capacity. However, our results should be interpreted in the context of its limitations.",2019,"These devices apply intermittent pressure to the legs improving arterial blood flow, mobilization of pooled blood with an increase in venous return increasing the effective circulatory volume.","['Patients with end-stage renal disease (ESRD) experience frequent hemodialysis (HD) complications', 'patients with ESRD', 'patients undergoing HD', 'patients receiving HD']","['IPC', 'Intermittent pneumatic compression', 'Intermittent pneumatic compression (IPC', 'exercise against IPC']","['rates of IDH with IPC', 'physical capacity and HD comfort', 'Intradialytic hypotension (IDH', 'HD comfort, ultrafiltration volume, and physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0274417', 'cui_str': 'Complication of hemodialysis (disorder)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",21.0,0.0902348,"These devices apply intermittent pressure to the legs improving arterial blood flow, mobilization of pooled blood with an increase in venous return increasing the effective circulatory volume.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torres', 'Affiliation': 'Department of Internal Medicine, John H. Stroger Jr. Hospital, Chicago, Illinois, USA.'}, {'ForeName': 'Harry E', 'Initials': 'HE', 'LastName': 'Fuentes', 'Affiliation': 'Department of Hematology and Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Saadaldin', 'Affiliation': 'Department of Medicine, October 6 University, Cairo, Egypt.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Salazar', 'Affiliation': 'Department of Internal Medicine, Northshore University Health System, Evanston, Illinois, USA.'}, {'ForeName': 'Luis H', 'Initials': 'LH', 'LastName': 'Paz', 'Affiliation': 'Department of Medicine, Division of Cardiology, Northshore University Health System, Evanston, Illinois, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Diaz', 'Affiliation': 'Department of Internal Medicine, Northshore University Health System, Evanston, Illinois, USA.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Doukky', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Hart', 'Affiliation': 'Department of Medicine, Division of Nephrology, John H. Stroger Jr. Hospital, Chicago, Illinois, USA.'}, {'ForeName': 'Alfonso J', 'Initials': 'AJ', 'LastName': 'Tafur', 'Affiliation': 'Department of Medicine, Division of Vascular Medicine, NorthShore University Health System, Evanston, Illinois, USA.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12771']
1250,31839957,"A 3-day low-fibre diet does not improve colonoscopy preparation results compared to a 1-day diet: A randomized, single-blind, controlled trial.","Background


Although a 1-day low-fibre diet before colonoscopy is currently recommended, some endoscopists prescribe a 3-day diet.
Objective


The objective of this study was to compare the influence of a 3-day versus a 1-day low-fibre diet on bowel preparation quality, patient tolerability and adherence.
Methods


Outpatients scheduled for total colonoscopy were randomized in two groups, 3-day versus 1-day low-fibre diet, performing a 4-litre polyethylene glycol split-dose. The primary outcome was a reduction of inappropriate preparations in the 3-day low-fibre diet arm from 15% to 5% (bowel preparation was assessed by the Boston Bowel Preparation Scale). Secondary outcomes were adherence to, difficulty to perform, difficulty to obtain and willingness to repeat the diet. Intention-to-treat (ITT) and per-protocol (PP) analyses were conducted for the primary outcome.
Results


A total of 412 patients were randomized (206 per group). Bowel preparation quality was similar between groups. On ITT analysis ( n  = 412), adequate bowel preparation was 91.7% (3-day diet) versus 94.7% (1-day diet),  p  = 0.24 and on PP analysis ( n  = 400) 93.5% versus 96.5%, respectively,  p  = 0.16. Difficulty to perform the diet was significantly higher on the 3-day diet,  p  = 0.04. No differences were found on difficulty to obtain the diet, willingness to repeat the diet, adverse events and intra-colonoscopy findings.
Conclusion


A 3-day low-fibre diet does not bring benefit to the bowel preparation quality and is harder to perform than a 1-day diet.",2019,"No differences were found on difficulty to obtain the diet, willingness to repeat the diet, adverse events and intra-colonoscopy findings.
","['Methods\n\n\nOutpatients scheduled for total colonoscopy', '412 patients']","['1-day low-fibre diet', 'Intention-to-treat (ITT) and per-protocol (PP', '3-day low-fibre diet', '3-day versus 1-day low-fibre diet, performing a 4-litre polyethylene glycol split-dose']","['reduction of inappropriate preparations in the 3-day low-fibre diet arm from 15% to 5% (bowel preparation was assessed by the Boston Bowel Preparation Scale', 'Bowel preparation quality', 'difficulty to obtain the diet, willingness to repeat the diet, adverse events and intra-colonoscopy findings', 'bowel preparation quality, patient tolerability and adherence', 'adherence to, difficulty to perform, difficulty to obtain and willingness to repeat the diet', 'adequate bowel preparation']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0009556', 'cui_str': 'Total colonoscopy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0344356', 'cui_str': 'Restricted fiber diet (finding)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0344356', 'cui_str': 'Restricted fiber diet (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}]",412.0,0.0586382,"No differences were found on difficulty to obtain the diet, willingness to repeat the diet, adverse events and intra-colonoscopy findings.
","[{'ForeName': 'Filipe', 'Initials': 'F', 'LastName': 'Taveira', 'Affiliation': 'Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Areia', 'Affiliation': 'Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Elvas', 'Affiliation': 'Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Alves', 'Affiliation': 'Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Brito', 'Affiliation': 'Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Saraiva', 'Affiliation': 'Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Ana T', 'Initials': 'AT', 'LastName': 'Cadime', 'Affiliation': 'Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Coimbra, Portugal.'}]",United European gastroenterology journal,['10.1177/2050640619883176']
1251,31839158,Estimating the magnitude of clinical benefit of systemic therapy in patients with DCIS or pre-invasive disease of the breast.,"The challenge of effective management of ductal carcinoma in situ (DCIS) and other pre-malignant disorders of the breast is to select patients who will not progress to invasive carcinoma from those at the highest risk who require radiotherapy and/or endocrine therapy to minimize the risk of a subsequent invasive recurrence. Although IBIS-II and NSABP-B35 DCIS phase III trials proved that tamoxifen 20 mg/day and anastrozole reduce the risk of ipsilateral and contralateral events, the toxicities of both drugs have hampered the drug uptake by high-risk women. We recently reported results of a 3-year placebo-controlled trial of low-dose (5 mg/d) tamoxifen in 500 women with intraepithelial neoplasia (70% DCIS). At a median follow-up of 5 years, women randomly assigned to low-dose tamoxifen had half the number of subsequent diagnoses of DCIS or invasive cancer compared with those randomly assigned to placebo but no increase in thromboembolic events or endometrial cancers. The 5-year number needed to treat was 22 (95% CI, 20-27). Our attention is now focused on prognostic and predictive markers to identify patients who can derive the greatest benefits from low dose tamoxifen, such as for instance the expression of 23 genes involved in cell cycle progression (CCP). In conclusion, we endorse an active treatment of DCIS as the standard of care.",2019,"The 5-year number needed to treat was 22 (95% CI, 20-27).","['500 women with intraepithelial neoplasia (70% DCIS', 'patients with DCIS or pre-invasive disease of the breast']","['radiotherapy and/or endocrine therapy', 'tamoxifen', 'placebo', 'anastrozole']","['number of subsequent diagnoses of DCIS or invasive cancer', 'thromboembolic events or endometrial cancers', '5-year number needed to treat']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0006141', 'cui_str': 'Breast'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}]",500.0,0.117553,"The 5-year number needed to treat was 22 (95% CI, 20-27).","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lazzeroni', 'Affiliation': 'Division of Cancer Prevention and Genetics, IEO European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Puntoni', 'Affiliation': 'Clinical Trial Office, E.O. Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Provinciali', 'Affiliation': 'Division of Medical Oncology, E.O. Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Tania Buttiron', 'Initials': 'TB', 'LastName': 'Webber', 'Affiliation': 'Division of Medical Oncology, E.O. Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Irene Maria', 'Initials': 'IM', 'LastName': 'Briata', 'Affiliation': 'Division of Medical Oncology, E.O. Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': ""D'Amico"", 'Affiliation': 'Division of Medical Oncology, E.O. Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Giuliano', 'Affiliation': 'Division of Medical Oncology, E.O. Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Siri', 'Affiliation': 'Clinical Trial Office, E.O. Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cagnacci', 'Affiliation': 'Division of Cancer Prevention and Genetics, IEO European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'DeCensi', 'Affiliation': 'Division of Medical Oncology, E.O. Ospedali Galliera, Genoa, Italy; Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, United Kingdom. Electronic address: andrea.decensi@galliera.it.'}]","Breast (Edinburgh, Scotland)",['10.1016/S0960-9776(19)31121-X']
1252,31839555,Comparison of cognitive adverse effects and efficacy of 2 pulse widths (0.5 ms and 1.5 ms) of brief pulse bilateral electroconvulsive therapy in patients with schizophrenia - A randomized single blind controlled trial.,,2020,,['patients with schizophrenia '],['2 pulse widths (0.5\xa0ms and 1.5\xa0ms) of brief pulse bilateral electroconvulsive therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0444804', 'cui_str': 'Brief pulse (qualifier value)'}, {'cui': 'C0562343', 'cui_str': 'Bilateral electroconvulsive therapy (procedure)'}]",[],,0.097881,,"[{'ForeName': 'Dhruva', 'Initials': 'D', 'LastName': 'Ithal', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Bangalore, India.'}, {'ForeName': 'Shyam Sundar', 'Initials': 'SS', 'LastName': 'Arumugham', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Bangalore, India.'}, {'ForeName': 'Channaveerachari Naveen', 'Initials': 'CN', 'LastName': 'Kumar', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Bangalore, India.'}, {'ForeName': 'Ramesh J', 'Initials': 'RJ', 'LastName': 'Venkatapura', 'Affiliation': 'Department of Neuro-anesthesia, National Institute of Mental Health and Neuro Sciences, Bangalore, India.'}, {'ForeName': 'Jagadisha', 'Initials': 'J', 'LastName': 'Thirthalli', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Bangalore, India. Electronic address: jagatth@yahoo.com.'}, {'ForeName': 'Bangalore N', 'Initials': 'BN', 'LastName': 'Gangadhar', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Bangalore, India.'}]",Schizophrenia research,['10.1016/j.schres.2019.11.062']
1253,31252293,Pattern of failure after adjuvant radiotherapy following extrapleural pneumonectomy of pleural mesothelioma in the SAKK 17/04 trial.,"Postoperative radiotherapy after extrapleural pneumonectomy of malignant pleural mesothelioma was investigated in the randomized phase II trial SAKK17/04. The relapse rate within the high and/or low-dose PTV without previous distant failure was 24%, the isolated in-field-relapse rate within the PTVs was 5% and the distant relapse rate outside of the PTVs was 81%. Clinical outcome was mainly determined by distant disease progression outside of the radiation field.",2019,"The relapse rate within the high and/or low-dose PTV without previous distant failure was 24%, the isolated in-field-relapse rate within the PTVs was 5% and the distant relapse rate outside of the PTVs was 81%.",['after extrapleural pneumonectomy of malignant pleural mesothelioma'],"['Postoperative radiotherapy', 'adjuvant radiotherapy']",['relapse rate'],"[{'cui': 'C0396583', 'cui_str': 'Extrapleural pneumonectomy (procedure)'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura (disorder)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.0380047,"The relapse rate within the high and/or low-dose PTV without previous distant failure was 24%, the isolated in-field-relapse rate within the PTVs was 5% and the distant relapse rate outside of the PTVs was 81%.","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Riesterer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Center for Radiation Oncology KSA-KSB, Kantonsspital Aarau, Switzerland. Electronic address: oliver.riesterer@ksa.ch.'}, {'ForeName': 'I Frank', 'Initials': 'IF', 'LastName': 'Ciernik', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Dessau, Germany.'}, {'ForeName': 'Rolf A', 'Initials': 'RA', 'LastName': 'Stahel', 'Affiliation': 'Cancer Center Zurich, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Xyrafas', 'Affiliation': 'Swiss Group for Clinical Cancer Research (SAKK) Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Aebersold', 'Affiliation': 'Department of Radiation Oncology, Inselspital, University Hospital Bern, University of Bern, Switzerland.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Plasswilm', 'Affiliation': 'Department of Radiation Oncology, Kantonsspital St. Gallen, St. Gallen, University of Bern, Switzerland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mahmut Ozsahin', 'Affiliation': 'Department of Radiation Oncology, University Hospital Lausanne - CHUV, Lausanne, Switzerland.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Zwahlen', 'Affiliation': 'Department of Radiation Oncology, Kantonsspital Graubünden, Chur, Switzerland.'}, {'ForeName': 'Kristiaan', 'Initials': 'K', 'LastName': 'Nackaerts', 'Affiliation': 'Department of Pneumology, KU Leuven, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Radiation Oncology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sabrina Stark', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Weder', 'Affiliation': 'Thoracic Surgery Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Krayenbuehl', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2019.05.024']
1254,30796566,The Effect of Spiritual Care on Perceived Stress and Mental Health Among the Elderlies Living in Nursing Home.,"The aim of this study was to investigate the effect of spiritual care on the perceived stress and mental health of the elderlies living in nursing home in Isfahan. This is a semi-experimental study with pretest and posttest design with control group. Ninety eligible elderlies living in the nursing home were divided into intervention and control groups through census and random allocation. The interventional spiritual care was conducted for the intervention group for 90 days. After conducting the spiritual care, the majority of the elderlies (62.22%) in the intervention group had a low perceived stress level and the majority of the subjects (64.44%) in the control group had a high perceived stress level. Therefore, after performing spiritual care, a significant difference was observed at the perceived stress level of the two groups (X 2  = 3.22 and P = 0.001). The results of mental health level indicated that the mean score of the general health questionnaire was ranged between 10.95 and 27.2. After performing care, a significant difference was observed in mental health level of both groups, and 31.11% and 53.33% of the participants were suspected to general disorder in the intervention and control groups, respectively. Based on the results, there was a significant difference in the mental health level of both groups after the implementation of spiritual care (X 2  = 6.56 and P = 0.001). Further, a significant negative correlation was found between the perceived stress and mental health (r = - 0.241 and P = 0.01). Considering the spiritual health as one of the health dimensions influencing the psychosocial variables of elderlies seems necessary. Policymakers and planners of health area contribute to the improvement of mental health level by using comprehensive care approach with an emphasis on the spiritual dimension of care for the elderly people.",2019,"After conducting the spiritual care, the majority of the elderlies (62.22%) in the intervention group had a low perceived stress level and the majority of the subjects (64.44%) in the control group had a high perceived stress level.","['Elderlies Living in Nursing Home', 'nursing home in Isfahan', 'Ninety eligible elderlies living in the nursing home']","['Spiritual Care', 'spiritual care']","['high perceived stress level', 'perceived stress and mental health', 'mean score of the general health questionnaire', 'mental health level', 'stress level']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home (finding)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}]","[{'cui': 'C0150355', 'cui_str': 'Spiritual support'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire (assessment scale)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",90.0,0.0224923,"After conducting the spiritual care, the majority of the elderlies (62.22%) in the intervention group had a low perceived stress level and the majority of the subjects (64.44%) in the control group had a high perceived stress level.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': 'School of Nursing and Midwifery, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Mansureh', 'Initials': 'M', 'LastName': 'Ghodusi Borujeni', 'Affiliation': 'Young Researchers and Elite Club, Abadeh Branch, Islamic Azad University, Abadeh, Iran. mghodosi@iauabadeh.ac.ir.'}, {'ForeName': 'Shokouh', 'Initials': 'S', 'LastName': 'Kabirian Abyaneh', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Rezaei', 'Affiliation': 'Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of religion and health,['10.1007/s10943-019-00782-1']
1255,31749143,Baseline findings and safety of infrequent vs. frequent screening of human papillomavirus vaccinated women.,"Less frequent cervical cancer screening in human papillomavirus (HPV) vaccinated birth cohorts could produce considerable savings without increasing cervical cancer incidence and loss of life-years. We report here the baseline findings and interim results of safety and accuracy of infrequent screening among HPV16/18 vaccinated females. The entire 1992-1994 birth-cohorts (30,139 females) were invited to a community-randomized HPV16/18-vaccination trial. A total of 9,482 female trial participants received HPV16/18-vaccination in 2007-2009 at age of 13-15. At age 22, 4,273 (45%) of these females consented to attend a randomized trial on frequent (ages 22/25/28; Arm 1: 2,073 females) vs. infrequent screening (age 28; Arm 2: 2,200 females) in 2014-2017. Females (1,329), who had got HPV16/18 vaccination at age 18 comprised the safety Arm 3. Baseline prevalence and incidence of HPV16/18 and other high-risk HPV types were: 0.5% (53/1,000 follow-up years, 10 4  ) and 25% (2,530/10 4  ) in the frequently screened Arm 1; 0.2% (23/10 4  ) and 24% (2,413/10 4  ) in the infrequently screened Arm 2; and 3.1% (304/10 4  ) and 23% (2,284/10 4  ) in the safety Arm 3. Corresponding prevalence of HSIL/ASC-H and of any abnormal cytological findings were: 0.3 and 4.2% (Arm 1), 0.4 and 5.3% (Arm 2) and 0.3 and 4.7% (Arm 3). Equally rare HSIL/CIN3 findings in the infrequently screened safety Arm A3 (0.4%) and in the frequently screened Arm 1 (0.4%) indicate no safety concerns on infrequent screening despite the up to 10 times higher HPV16/18 baseline prevalence and incidence in the former.",2020,Less frequent cervical cancer screening in human papillomavirus (HPV) vaccinated birth cohorts could produce considerable savings without increasing cervical cancer incidence and loss of life-years.,"['The entire 1992-94 birth-cohorts (30139 females', 'A total of 9,482 female trial participants received HPV16/18-vaccinationin 2007-09 at age of 13-15', 'Females (1329), who had got HPV16/18 vaccination at age 18 comprised the safety Arm 3', 'HPV16/18 vaccinated females', 'At age 22, 4273 (45%) of these females consented to attend a randomized trial on frequent (ages 22/25/28)(Arm 1: 2073females) vs. infrequent screening (age 28)(Arm 2: 2200females) in 2014-2017', 'human papillomavirus vaccinated women']",[],"['safety Arm 3.Corresponding prevalence of HSIL/ASC-H and of any abnormal cytological findings', 'Baseline prevalence and incidence of HPV16/18 and other high-risk HPV types']","[{'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0521114', 'cui_str': 'Infrequent (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0333875', 'cui_str': 'HSIL, High-Grade Squamous Intraepithelial Lesions'}, {'cui': 'C1510966', 'cui_str': 'ASC-H'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0205471', 'cui_str': 'Cytologic (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0201679', 'cui_str': 'Human papillomavirus typing (procedure)'}]",94.0,0.0697308,Less frequent cervical cancer screening in human papillomavirus (HPV) vaccinated birth cohorts could produce considerable savings without increasing cervical cancer incidence and loss of life-years.,"[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Louvanto', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Eriksson', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Apter', 'Affiliation': 'VL-Medi Clinical Research Center, Family Federation Finland, Helsinki, Finland.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Baussano', 'Affiliation': 'Infections and Cancer Epidemiology Group, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bly', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Harjula', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Heikkilä', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital, University of Turku, Turku, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hokkanen', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Huhtinen', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Ikonen', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Karttunen', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Mervi', 'Initials': 'M', 'LastName': 'Nummela', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Söderlund-Strand', 'Affiliation': 'Department of Clinical Microbiology, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Veivo', 'Affiliation': 'Department of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Dillner', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Elfstöm', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Nieminen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Lehtinen', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.'}]",International journal of cancer,['10.1002/ijc.32802']
1256,31272205,Exercise-based cardiac rehabilitation for patients with catheter ablation for persistent atrial fibrillation: A randomized controlled clinical trial.,"AIMS


The efficacy and safety of cardiac rehabilitation for patients with persistent atrial fibrillation who restored sinus rhythm after catheter ablation remains unclear. The aim of the present study was to evaluate the effects of cardiac rehabilitation on exercise capacity, inflammatory status, cardiac function, and safety in patients with persistent atrial fibrillation who had catheter ablation.
METHODS


In this randomized controlled study, 61 patients treated with catheter ablation for persistent atrial fibrillation (male, 80%; mean age, 66 ± 9 years) were analyzed. Thirty patients underwent cardiac rehabilitation (rehabilitation group), whereas the remaining 31 patients received usual care (usual care group). The rehabilitation group underwent endurance and resistance training with moderate intensity, at least three times per week for six months. Six-minute walk distance, muscle strength, serum high-sensitivity C-reactive protein, plasma pentraxin 3, left ventricular ejection fraction and atrial fibrillation recurrence were assessed at baseline and at six-month follow-up.
RESULTS


In the rehabilitation group, significant increases in the six-minute walk distance, handgrip strength, leg strength and left ventricular ejection fraction and significant decreases in high-sensitivity C-reactive protein and plasma pentraxin 3 concentrations were observed at six-month follow-up compared with baseline (all  p  < 0.05). No significant changes were observed in the usual care group. During the six-month follow-up period, the number of patients with atrial fibrillation recurrence was six (21.4%) in the rehabilitation group and eight (25.8%) in the usual care group (risk ratio, 0.83; 95% confidence interval, 0.33 to 2.10).
CONCLUSIONS


Cardiac rehabilitation improved exercise capacity without increasing the risk for atrial fibrillation recurrence. It may also be effective in managing systemic inflammatory status and systolic left ventricular function in patients with persistent atrial fibrillation treated with catheter ablation.",2019,"In the rehabilitation group, significant increases in the six-minute walk distance, handgrip strength, leg strength and left ventricular ejection fraction and significant decreases in high-sensitivity C-reactive protein and plasma pentraxin 3 concentrations were observed at six-month follow-up compared with baseline (all  p  < 0.05).","['Thirty patients underwent', 'patients with persistent atrial fibrillation who restored sinus rhythm after catheter ablation remains unclear', '61 patients treated with catheter ablation for persistent atrial fibrillation (male, 80%; mean age, 66\u2009±\u20099 years', 'patients with persistent atrial fibrillation treated with catheter ablation', 'patients with catheter ablation for persistent atrial fibrillation', 'patients with persistent atrial fibrillation who had catheter ablation']","['Exercise-based cardiac rehabilitation', 'cardiac rehabilitation', 'endurance and resistance training', 'usual care (usual care group', 'cardiac rehabilitation (rehabilitation group']","['six-minute walk distance, handgrip strength, leg strength and left ventricular ejection fraction', 'number of patients with atrial fibrillation recurrence', 'exercise capacity, inflammatory status, cardiac function, and safety', 'high-sensitivity C-reactive protein and plasma pentraxin 3 concentrations', 'Six-minute walk distance, muscle strength, serum high-sensitivity C-reactive protein, plasma pentraxin 3, left ventricular ejection fraction and atrial fibrillation recurrence', 'exercise capacity', 'efficacy and safety']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0174234', 'cui_str': 'TNF-stimulated gene 14'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",30.0,0.0470276,"In the rehabilitation group, significant increases in the six-minute walk distance, handgrip strength, leg strength and left ventricular ejection fraction and significant decreases in high-sensitivity C-reactive protein and plasma pentraxin 3 concentrations were observed at six-month follow-up compared with baseline (all  p  < 0.05).","[{'ForeName': 'Michitaka', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Department of Shizuoka Physical Therapy, Faculty of Health Science, Tokoha University, Shizuoka, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Ogano', 'Affiliation': 'Department of Cardiovascular Medicine, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Mori', 'Affiliation': 'Department of Rehabilitation, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Kaito', 'Initials': 'K', 'LastName': 'Kochi', 'Affiliation': 'Department of Rehabilitation, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Morimoto', 'Affiliation': 'Department of Rehabilitation, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kito', 'Affiliation': 'Department of Rehabilitation, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Fumi Nihei', 'Initials': 'FN', 'LastName': 'Green', 'Affiliation': 'Anti-aging Center, Ginza Hospital, Tokyo, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Tsukamoto', 'Affiliation': 'Department of Shizuoka Physical Therapy, Faculty of Health Science, Tokoha University, Shizuoka, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kubo', 'Affiliation': 'Department of Shizuoka Physical Therapy, Faculty of Health Science, Tokoha University, Shizuoka, Japan.'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Takagi', 'Affiliation': 'Department of Cardiovascular Surgery, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tanabe', 'Affiliation': 'Department of Cardiovascular Medicine, Shizuoka Medical Center, Shizuoka, Japan.'}]",European journal of preventive cardiology,['10.1177/2047487319859974']
1257,31023843,"The effect of gefapixant, a P2X3 antagonist, on cough reflex sensitivity: a randomised placebo-controlled study.","We evaluated the effect of gefapixant on cough reflex sensitivity to evoked tussive challenge.In this phase 2, double-blind, two-period study, patients with chronic cough (CC) and healthy volunteers (HV) were randomised to single-dose gefapixant 100 mg or placebo in a crossover fashion. Sequential inhalational challenges with ATP, citric acid, capsaicin and distilled water were performed 1, 3 and 5 h after dosing. Mean concentrations evoking ≥2 coughs (C2) and ≥5 coughs (C5) post dose  versus  baseline were co-primary endpoints. Objective cough frequency (coughs·h -1 ) over 24 h and a cough severity visual analogue scale (VAS) were assessed in CC patients. Adverse events were monitored.24 CC patients and 12 HV were randomised (mean age 61 and 38 years, respectively). The cough challenge threshold increased for ATP by 4.7-fold (C2, p≤0.001) and 3.7-fold (C5, p=0.007) for gefapixant  versus  placebo in CC patients; in HV, C2 and C5 increased 2.4-fold (C2, p=0.113; C5, p=0.003). The distilled water C2 and C5 thresholds increased significantly (p<0.001) by a factor of 1.4 and 1.3, respectively, in CC patients. Gefapixant had no effect on capsaicin or citric acid challenge. Median cough frequency was reduced by 42% and the least squares mean cough severity VAS was 18.0 mm lower for gefapixant  versus  placebo in CC patients. Dysgeusia was the most frequent adverse event (75% of HV and 67% of CC patients).ATP-evoked cough was significantly inhibited by gefapixant 100 mg, demonstrating peripheral target engagement. Cough count and severity were reduced in CC patients. Distilled water may also evoke cough through a purinergic pathway.",2019,"The cough challenge threshold increased for ATP by 4.7-fold (C2, p≤0.001) and 3.7-fold (C5, p=0.007) for gefapixant  versus  placebo in CC patients; in HV, C2 and C5 increased 2.4-fold (C2, p=0.113; C5, p=0.003).",['patients with chronic cough (CC) and healthy volunteers (HV'],"['placebo', 'gefapixant, a P2X3 antagonist', 'ATP, citric acid, capsaicin and distilled water', 'gefapixant', 'gefapixant 100\u2005mg or placebo']","['Mean concentrations evoking ≥2 coughs (C2) and ≥5 coughs (C5', 'Dysgeusia', 'Adverse events', 'Cough count and severity', 'Objective cough frequency (coughs·h -1 ) over 24\u2005h and a cough severity visual analogue scale (VAS', 'capsaicin or citric acid challenge', 'evoked cough', 'cough reflex sensitivity', 'Median cough frequency', 'cough severity VAS', 'cough challenge threshold increased for ATP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0013378', 'cui_str': 'Taste, Distorted'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0232051', 'cui_str': 'Cough reflex (observable entity)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0001480', 'cui_str': 'ATP'}]",,0.0679462,"The cough challenge threshold increased for ATP by 4.7-fold (C2, p≤0.001) and 3.7-fold (C5, p=0.007) for gefapixant  versus  placebo in CC patients; in HV, C2 and C5 increased 2.4-fold (C2, p=0.113; C5, p=0.003).","[{'ForeName': 'Alyn H', 'Initials': 'AH', 'LastName': 'Morice', 'Affiliation': 'Hull York Medical School, Cottingham, UK.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Kitt', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Ford', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tershakovec', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Wu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Kayleigh', 'Initials': 'K', 'LastName': 'Brindle', 'Affiliation': 'Hull York Medical School, Cottingham, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Thompson', 'Affiliation': 'Hull York Medical School, Cottingham, UK.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Thackray-Nocera', 'Affiliation': 'Hull York Medical School, Cottingham, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wright', 'Affiliation': 'Hull York Medical School, Cottingham, UK.'}]",The European respiratory journal,['10.1183/13993003.00439-2019']
1258,31279078,Effects (MACE and bleeding events) of ticagrelor combined with omeprazole on patients with acute myocardial infarction undergoing primary PCI.,"BACKGROUND


This study aimed to investigate the effect of ticagrelor combined with omeprazole on patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention (PCI).
METHODS


Eighty-six patients with AMI who underwent primary PCI in Xinxiang Central Hospital between July 2015 and December 2016 were included and divided randomly into the observation group and the control group by the draw, with 43 patients in each group. All patients were routinely treated with dual antiplatelet therapy with aspirin plus ticagrelor. Omeprazole was used in the observation group and placebo was used in the control group. Data of baseline patient characteristics, platelet response index (PRI), ADP-induced platelet aggregation (ADP-Ag), major adverse cardiac events (MACE), and incidence of bleeding events were recorded and compared between both groups.
RESULTS


PRI and ADP-Ag at 7 days, 1 month, and 6 months after operation in both groups were significantly lower than those in the same group before administration (p < 0.017). Incidence of bleeding events in the observation group was significantly lower than that in the control group (p < 0.05).
CONCLUSION


For patients with AMI undergoing primary PCI, omeprazole was found to reduce the incidence of gastrointestinal bleeding without reducing the antiplatelet aggregation effect of ticagrelor or increasing the risk of MACE, which is worthy of clinical promotion.",2019,"For AMI patients undergoing primary PCI, omeprazole can reduce the incidence of gastrointestinal bleeding without reducing the antiplatelet aggregation effect of ticagrelor or increasing the risk of MACE, which is worthy of clinical promotion.","['86 patients with AMI underwent primary PCI in Xinxiang central hospital between July 2015 and December 2016', 'patients with acute myocardial infarction undergoing primary percutaneous coronary intervention (PCI', 'patients with acute myocardial infarction undergoing primary PCI']","['Omeprazole', 'placebo', 'ticagrelor combined with omeprazole', 'aspirin plus ticagrelor', 'omeprazole']","['incidence of MACE', 'Incidence of bleeding events', 'platelet response index (PRI) ADP-induced platelet aggregation (ADP-Ag), major adverse cardiac events (MACE), and incidence of bleeding events', 'Effects (MACE and bleeding events', 'hospital referral']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0019982', 'cui_str': 'Hospital Referral'}]",86.0,0.0138406,"For AMI patients undergoing primary PCI, omeprazole can reduce the incidence of gastrointestinal bleeding without reducing the antiplatelet aggregation effect of ticagrelor or increasing the risk of MACE, which is worthy of clinical promotion.","[{'ForeName': 'Fucheng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Xinxiang Central Hospital, Xinxiang, Henan 45300 China.'}, {'ForeName': 'Shuhong', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Department of Cardiology, Xinxiang Central Hospital, Xinxiang, Henan 45300 China.'}, {'ForeName': 'Yuyan', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Department of Cardiology, Xinxiang Central Hospital, Xinxiang, Henan 45300 China.'}, {'ForeName': 'Lipei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Xinxiang Central Hospital, Xinxiang, Henan 45300 China.'}, {'ForeName': 'Zhifang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Xinxiang Central Hospital, Xinxiang, Henan 45300 China. Electronic address: zmd6hj@163.com.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Hepatology, 371 PLA Hospital, Xinxiang, Henan 45300 China.'}, {'ForeName': 'Fengli', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology, Xinxiang, Henan 45300 China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Xinxiang, Henan 45300 China.'}]",Hellenic journal of cardiology : HJC = Hellenike kardiologike epitheorese,['10.1016/j.hjc.2019.06.001']
1259,31272550,Accelerated Allograft Vasculopathy With Rituximab After Cardiac Transplantation.,"BACKGROUND


The CTOT-11 (Prevention of Cardiac Allograft Vasculopathy Using Rituximab Therapy in Cardiac Transplantation [Clinical Trials in Organ Transplantation-11]) study was a randomized, placebo-controlled, multicenter, double-blinded clinical trial in nonsensitized primary heart transplant (HTX) recipients.
OBJECTIVES


The study sought to determine whether B cell depletion therapy would attenuate the development of cardiac allograft vasculopathy.
METHODS


A total of 163 HTX recipients were randomized to rituximab 1,000 mg intravenous or placebo on days 0 and 12 post-transplant. Primary outcome was change in percent atheroma volume (PAV) from baseline to 1 year measured by intravascular ultrasound. Secondary outcomes included treated episodes of acute rejection, de novo anti-HLA antibodies (including donor-specific antibodies), and phenotypic differentiation of B cells.
RESULTS


There were no significant differences at study entry between the rituximab and placebo groups. Paired intravascular ultrasound measures were available at baseline and 1 year in 86 subjects (49 rituximab, 37 placebo). The mean ± SD change in PAV at 12 months was +6.8 ± 8.2% rituximab versus +1.9 ± 4.4% placebo (p = 0.0019). Mortality at 12 months was 3.4% rituximab versus 6.8% placebo (p = 0.47); there were no retransplants or post-transplant lymphoproliferative disorder. The rate of treated rejection was 24.7% rituximab versus 32.4% placebo (p = 0.28). Rituximab therapy effectively eliminated CD20 + /CD19 +  B cells followed by a gradual expansion of a CD19 -  cell population in the rituximab-treated group.
CONCLUSIONS


A marked, unexpected increase in coronary artery PAV with rituximab was observed during the first year in HTX recipients. One-year mortality was not impacted; however, longer-term follow-up and mechanistic explanations are required. (Prevention of Cardiac Allograft Vasculopathy Using Rituximab [Rituxan] Therapy in Cardiac Transplantation; NCT01278745).",2019,Mortality at 12 months was 3.4% rituximab versus 6.8% placebo (p = 0.47); there were no retransplants or post-transplant lymphoproliferative disorder.,"['163 HTX recipients', 'nonsensitized primary heart transplant (HTX) recipients']","['Rituximab', 'placebo', 'B cell depletion therapy', 'Rituximab [Rituxan', 'Rituximab Therapy', 'rituximab 1,000']","['mean ± SD change in PAV', 'treated episodes of acute rejection, de novo anti-HLA antibodies (including donor-specific antibodies), and phenotypic differentiation of B cells', 'Mortality', 'CD20 + /CD19 ', 'rate of treated rejection', 'percent atheroma volume (PAV', 'coronary artery PAV with rituximab']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1171324', 'cui_str': 'B-cell depletion therapy'}, {'cui': 'C0732355', 'cui_str': 'Rituxan'}, {'cui': 'C4047978', 'cui_str': 'Rituximab therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0024284', 'cui_str': 'Lymphocytotoxic Antibodies'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0264956', 'cui_str': 'Atheromatous Plaques'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]",163.0,0.526903,Mortality at 12 months was 3.4% rituximab versus 6.8% placebo (p = 0.47); there were no retransplants or post-transplant lymphoproliferative disorder.,"[{'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Department of Medicine, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address: https://twitter.com/rcstarling.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, North Carolina.'}, {'ForeName': 'Nancy D', 'Initials': 'ND', 'LastName': 'Bridges', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Eisen', 'Affiliation': 'Department of Medicine, Drexel University College of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Transplantation Research Center, Renal Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Abdallah G', 'Initials': 'AG', 'LastName': 'Kfoury', 'Affiliation': 'Department of Medicine, Intermountain Medical Center, Murray, Utah.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Kobashigawa', 'Affiliation': 'Department of Medicine, Cedars Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ikle', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, North Carolina.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Morrison', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Pinney', 'Affiliation': 'Department of Medicine, Mount Sinai School of Medicine, New York, New York.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Stehlik', 'Affiliation': 'Department of Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Sudipta', 'Initials': 'S', 'LastName': 'Tripathi', 'Affiliation': ""Transplantation Research Center, Renal Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Sayegh', 'Affiliation': ""Transplantation Research Center, Renal Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Chandraker', 'Affiliation': ""Transplantation Research Center, Renal Division, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: achandraker@bwh.harvard.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.04.056']
1260,31276163,Nivolumab in Metastatic Adrenocortical Carcinoma: Results of a Phase 2 Trial.,"CONTEXT


Systemic treatment of metastatic adrenocortical carcinoma (ACC) remains limited to chemotherapy and mitotane. Preliminary evidence suggesting that antitumor immune responses can be elicited in ACC has fostered interest in checkpoint inhibitors such as anti-PD-1 nivolumab.
OBJECTIVE


The primary endpoint was objective response rate according to the response evaluation criteria in solid tumors. Secondary endpoints were progression-free survival (PFS), overall survival, and safety.
DESIGN


Single-arm, multicenter, phase 2 clinical trial with two-stage design.
SETTING


Comprehensive cancer center.
PATIENTS


Ten adult patients with metastatic ACC previously treated with platinum-based chemotherapy and/or mitotane as well as patients who declined front-line chemotherapy.
INTERVENTION


Nivolumab (240 mg) IV every 2 weeks.
RESULTS


Ten patients with metastatic ACC were enrolled between March and December 2016. The median number of doses of nivolumab administered was two. Three patients only received one treatment [one died of disease progression, one discontinued due to adverse events (AEs), one withdrew after beginning treatment]. The median PFS was 1.8 months. The median follow-up was 4.5 months (range, 0.1 to 25.6 months). Two patients had stable disease for a duration of 48 and 11 weeks, respectively. One patient had an unconfirmed partial response but discontinued the study due to an AE. Most AEs were grade 1/2. The most common grade 3/4 treatment-related AEs were aspartate aminotransferase and alanine aminotransferase elevations, mucositis, and odynophagia.
CONCLUSION


Nivolumab demonstrated modest antitumor activity in patients with advanced ACC. The nivolumab safety profile was consistent with previous clinical experience without any unexpected AEs in this population.",2019,"The most common grade 3/4 treatment-related adverse events were AST and ALT elevations, mucositis and odynophagia.
","['Ten adult patients with metastatic ACC previously treated with', 'metastatic adrenocortical carcinoma', 'Comprehensive cancer center', 'Ten patients with metastatic ACC were enrolled between March and December, 2016', 'metastatic adrenocortical carcinoma (ACC', 'patients with advanced ACC']","['platinum-based chemotherapy and/or mitotane', 'Nivolumab', 'Nivolumab 240 mg intravenous every 2 weeks']","['AST and ALT elevations, mucositis and odynophagia', 'antitumor activity', 'progression-free survival (PFS), overall survival (OS) and safety', 'objective response rate', 'median number of doses of nivolumab', 'median PFS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0206686', 'cui_str': 'Carcinoma, Adrenal Cortical'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0026256', 'cui_str': 'Mitotane'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0221150', 'cui_str': 'Swallowing painful (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]",10.0,0.236976,"The most common grade 3/4 treatment-related adverse events were AST and ALT elevations, mucositis and odynophagia.
","[{'ForeName': 'Benedito A', 'Initials': 'BA', 'LastName': 'Carneiro', 'Affiliation': 'Developmental Therapeutics Program, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Bhavana', 'Initials': 'B', 'LastName': 'Konda', 'Affiliation': 'Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Rubens B', 'Initials': 'RB', 'LastName': 'Costa', 'Affiliation': 'Developmental Therapeutics Program, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Ricardo L B', 'Initials': 'RLB', 'LastName': 'Costa', 'Affiliation': 'Developmental Therapeutics Program, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Sagar', 'Affiliation': 'Developmental Therapeutics Program, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Demirkan B', 'Initials': 'DB', 'LastName': 'Gursel', 'Affiliation': 'Department of Pathology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kirschner', 'Affiliation': 'Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Young Kwang', 'Initials': 'YK', 'LastName': 'Chae', 'Affiliation': 'Developmental Therapeutics Program, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Sarki A', 'Initials': 'SA', 'LastName': 'Abdulkadir', 'Affiliation': 'Developmental Therapeutics Program, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Rademaker', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Devalingam', 'Initials': 'D', 'LastName': 'Mahalingam', 'Affiliation': 'Developmental Therapeutics Program, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Manisha H', 'Initials': 'MH', 'LastName': 'Shah', 'Affiliation': 'Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Giles', 'Affiliation': 'Developmental Therapeutics Program, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00600']
1261,31242506,"Effectiveness of two guided self-administered interventions for psychological distress among women with infertility: a three-armed, randomized controlled trial.","STUDY QUESTION


What is the effect of two guided self-administered interventions on psychological distress in women undergoing IVF or ICSI?
SUMMARY ANSWER


A brief mindfulness intervention significantly reduced depression and improved sleep quality, while the gratitude journal intervention showed no significant effect on any outcome variables.
WHAT IS KNOWN ALREADY


Mindfulness and gratitude journal interventions have been found to be beneficial in reducing negative affect and improving well-being. However, there are very few mental health professionals who implement such interventions in low- and middle-income countries. Therefore, two guided self-administered interventions for women with infertility were designed to help them cope with their psychological distress.
STUDY DESIGN, SIZE, DURATION


A three-armed, randomized controlled trial was designed to evaluate the mindfulness and gratitude journal interventions for women undergoing IVF/ICSI. Between May 2016 and November 2017, at the reproductive center in a public hospital, 234 women were randomly assigned to the brief mindfulness group (BMG, n = 78), gratitude journal group (GJG, n = 78) or control group (CG, n = 78). The inclusion criteria were being a woman undergoing her first cycle of IVF, having at least junior middle school education and having no biological or adopted children.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Female infertility patients (n = 346) were approached, and 112 did not meet the inclusion criteria. All three randomized groups completed questionnaires on the day of down-regulation (T1), the day before embryo(s) transfer (T2), and 3 days before the pregnancy test (T3). The BMG completed four sessions and listened to a 20-minute audio daily, including guided mindfulness breathing and body scan. The GJG completed four sessions and wrote three gratitude journals daily. The CG received routine care. A generalized estimating equation was used in an intention-to-treat analysis. The primary outcome was depression. Secondary outcomes were anxiety, sleep quality, infertility-related stress, mindfulness and gratitude.
MAIN RESULTS AND THE ROLE OF CHANCE


Participants of the BMG showed decreased depression (mean difference (MD) = -1.69, [-3.01, -0.37], d = 0.44) and improved sleep quality (MD = -1.24, [-1.95, -0.39], d = 0.43) compared to the CG, but the effect was not significant for anxiety, Fertility Problem Inventory totals, mindfulness, gratitude scores or pregnancy rates. The BMG showed a significant reduction in depression and improvement in sleep quality between T1 and T2, a continuous significant reduction between T1 and T3 and no reduction between T2 and T3. There were no significant effects on any of the variables for the GJG.
LIMITATIONS, REASONS FOR CAUTION


The inclusion criteria may result in bias because some participants with low education were excluded and only women with infertility were included. A low compliance rate occurred in the gratitude journals group. Moreover, men were not included in this study. Further research should consider including spouses of the target population.
WIDER IMPLICATIONS OF THE FINDINGS


The brief mindfulness intervention was beneficial in decreasing depression and improving sleep quality. Implementation of guided self-administered mindfulness could make the psychological counseling service more accessible for patients with infertility in resource-poor settings. The efficiency and feasibility of the gratitude journal intervention needs to be investigated further.
STUDY FUNDING/COMPETING INTEREST(S)


This study was funded by the National Social Science Foundation (17BSH054). The authors have no conflicts of interest.
TRIAL REGISTRATION NUMBER


ChiCTR-IOR-16008452.
TRIAL REGISTRATION DATE


9 May 2016.
DATE OF FIRST PATIENT’S ENROLMENT


15 May 2016.",2019,"The BMG showed a significant reduction in depression and improvement in sleep quality between T1 and T2, a continuous significant reduction between T1 and T3 and no reduction between T2 and T3.","['Female infertility patients (n\u2009=\u2009346) were approached, and 112 did not meet the inclusion criteria', 'patients with infertility in resource-poor settings', 'participants with low education were excluded and only women with infertility were included', 'Between May 2016 and November 2017, at the reproductive center in a public hospital, 234 women', 'women with infertility', 'woman undergoing her first cycle of IVF, having at least junior middle school education and having no biological or adopted children', 'women undergoing IVF/ICSI', 'women undergoing IVF or ICSI']","['guided mindfulness breathing and body scan', 'guided self-administered interventions', 'mindfulness intervention', 'brief mindfulness group (BMG, n\u2009=\u200978), gratitude journal group (GJG, n\u2009=\u200978) or control group (CG']","['compliance rate', 'psychological distress', 'anxiety, sleep quality, infertility-related stress, mindfulness and gratitude', 'depression', 'anxiety, Fertility Problem Inventory totals, mindfulness, gratitude scores or pregnancy rates', 'depression and improving sleep quality', 'sleep quality', 'depression and improved sleep quality']","[{'cui': 'C0021361', 'cui_str': 'Female infertility (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0337541', 'cui_str': 'Adopted child (person)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0441633'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0278048', 'cui_str': 'Fertility problem (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",234.0,0.130669,"The BMG showed a significant reduction in depression and improvement in sleep quality between T1 and T2, a continuous significant reduction between T1 and T3 and no reduction between T2 and T3.","[{'ForeName': 'Cai-Feng', 'Initials': 'CF', 'LastName': 'Bai', 'Affiliation': 'School of Nursing, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.'}, {'ForeName': 'Nai-Xue', 'Initials': 'NX', 'LastName': 'Cui', 'Affiliation': 'School of Nursing, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Reproductive Medicine Center, General Hospital of Ningxia Medical University, 804 Sheng Li Street, Yinchuan 750004, China.'}, {'ForeName': 'Guang-Li', 'Initials': 'GL', 'LastName': 'Mi', 'Affiliation': 'Nursing Department, General Hospital of Ningxia Medical University, 804 Sheng Li Street, Yinchuan 750004, China.'}, {'ForeName': 'Ji-Wei', 'Initials': 'JW', 'LastName': 'Sun', 'Affiliation': 'School of Nursing, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Shao', 'Affiliation': 'School of Health Care Management, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.'}, {'ForeName': 'Yin-Zhi', 'Initials': 'YZ', 'LastName': 'Jiang', 'Affiliation': 'Reproductive Medicine Center, General Hospital of Ningxia Medical University, 804 Sheng Li Street, Yinchuan 750004, China.'}, {'ForeName': 'Qian-Qian', 'Initials': 'QQ', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.'}, {'ForeName': 'Feng-Lin', 'Initials': 'FL', 'LastName': 'Cao', 'Affiliation': 'School of Nursing, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez066']
1262,31097299,"Four-week trunk-specific exercise program decreases forward trunk flexion in Parkinson's disease: A single-blinded, randomized controlled trial.","INTRODUCTION


Pathological forward trunk flexion is a disabling and drug-refractory motor complication of Parkinson's disease (PD) leading to imbalance, pain, and fall-related injuries. Since it might be reversible, early and multidisciplinary management is emphasised. The primary aim was to compare the effects of a four-week trunk-specific rehabilitation program on the severity of the forward trunk flexion. The secondary aim was to compare the training effects on the motor impairments, dynamic and static balance, pain, falls, and quality of life.
METHODS


37 patients with PD (H&Y ≤ 4) and forward trunk flexion were randomized in the experimental (n = 19) or control group (n = 18). The former consisted of active self-correction exercises with visual and proprioceptive feedback, passive and active trunk stabilization exercises and functional tasks. The latter consisted of joint mobilization, muscle strengthening and stretching, gait and balance exercises. Protocols lasted 4 weeks (60 min/day, 5 days/week). Before, after, and at 1-month follow-up, a blinded examiner evaluated patients using primary and secondary outcomes. The primary outcome was the forward trunk flexion severity (degree). Secondary outcomes were the UPDRS III, dynamic and static balance, pain falls, and quality of life assessment.
RESULTS


The experimental group reported a significantly greater reduction in forward trunk flexion than the control group from T0 to both T1 (p = 0.003) and T2 (p = 0.004). The improvements in dynamic and static balance were significantly greater for the experimental group than the control group from T0 to T2 (p = 0.017 and 0.004, respectively). Comparable effects were reported on the other outcomes. Pre-treatment forward trunk flexion values were highly correlated to post-treatment trunk deviation changes.
CONCLUSION


The four-week trunk-specific rehabilitation training decreased the forward trunk flexion severity and increased postural control in patients with PD. NCT03741959.",2019,The experimental group reported a significantly greater reduction in forward trunk flexion than the control group from T0 to both T1 (p = 0.003) and T2 (p = 0.004).,"[""Parkinson's disease"", '37 patients with PD (H&Y\u202f≤\u202f4) and forward trunk flexion']","['specific exercise program', 'joint mobilization, muscle strengthening and stretching, gait and balance exercises', 'active self-correction exercises with visual and proprioceptive feedback, passive and active trunk stabilization exercises and functional tasks', 'four-week trunk-specific rehabilitation program']","['reduction in forward trunk flexion', 'trunk flexion values', 'motor impairments, dynamic and static balance, pain, falls, and quality of life', 'UPDRS III, dynamic and static balance, pain falls, and quality of life assessment', 'forward trunk flexion severity (degree', 'forward trunk flexion severity and increased postural control', 'trunk flexion', 'dynamic and static balance']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization (observable entity)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C2936180', 'cui_str': 'Proprioceptive Feedback'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0034380'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",37.0,0.0340804,The experimental group reported a significantly greater reduction in forward trunk flexion than the control group from T0 to both T1 (p = 0.003) and T2 (p = 0.004).,"[{'ForeName': 'Marialuisa', 'Initials': 'M', 'LastName': 'Gandolfi', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy; UOC Neurorehabilitation, AOUI Verona, Italy. Electronic address: marialuisa.gandolfi@univr.it.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tinazzi', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy. Electronic address: michele.tinazzi@univr.it.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Magrinelli', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Busselli', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy; UOC Neurorehabilitation, AOUI Verona, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Dimitrova', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy; UOC Neurorehabilitation, AOUI Verona, Italy.'}, {'ForeName': 'Niccolò', 'Initials': 'N', 'LastName': 'Polo', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manganotti', 'Affiliation': 'Department of Medical, Surgical, and Health Sciences, University of Trieste, Trieste, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Fasano', 'Affiliation': ""Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, UHN, Division of Neurology, University of Toronto, Toronto, Ontario, Canada; Krembil Brain Institute, Toronto, Ontario, Canada.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy; UOC Neurorehabilitation, AOUI Verona, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Geroin', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2019.05.006']
1263,31201057,Physician clinical decision support system prompts and administration of subsequent doses of HPV vaccine: A randomized clinical trial.,"BACKGROUND


HPV vaccine is effective in preventing several cancers and anogenital warts, yet rates of HPV vaccination series completion in the United States are low. A primary reason identified by parents for vaccinating children against HPV is a health care provider's recommendation. Although most clinicians embrace vaccine recommendations, they are not always carried out evenly and subsequent HPV vaccines are missed.
METHODS


Using an electronic health records-based decision support system (CHICA) clinicians were randomized to either usual practice or to receive an automated reminder to recommend the 2nd or 3rd dose of HPV vaccine. The reminder was delivered to clinicians of all intervention group eligible adolescents who had already initiated the vaccine series. Logistic regression models with generalized estimating equations were used for data analysis.
RESULTS


A total of 1285 clinical encounters were observed across 29 randomized pediatric providers over a 13-month time frame (50.7% control group, 49.3% intervention group). Overall, patients were 44.9% female, 59.4% Black, 22.1% Hispanic, and 48.8% were ages 11-12 yrs. Within the control group, 421 (64.7%) received a subsequent HPV vaccine, compared to 481 (75.9%) (OR: 1.72, (95% CI 1.35-2.19)). Adjusted analysis showed no difference between the groups (aOR 1.52 (95% CI 0.88-2.62)) or when examined by age (11-12yrs aOR 1.66, (95% CI 0.79-3.48)) and 13-17yrs (aOR 1.19, (95% CI 0.76-1.85)) or gender female (aOR 1.39 (95% CI 0.71-2.72)) and males (aOR 1.67 (95% CI 0.95-2.92)). When results were stratified by both age and gender, there was similarly no statistically significant effect between the two groups.
CONCLUSIONS


Automated physician reminders for subsequent 2nd and 3rd doses of HPV vaccination were used. Despite increased rates of vaccination in the intervention group, the differences did not reach the level of statistical significance. Future studies with multifaceted approaches may be needed to examine the efficacy of computer-based reminders.
CLINICAL TRIAL REGISTRATION


NCT02558803, ""HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3"".",2019,"Adjusted analysis showed no difference between the groups (aOR 1.52 (95% CI 0.88-2.62)) or when examined by age (11-12yrs aOR 1.66, (95% CI 0.79-3.48)) and 13-17yrs (aOR 1.19, (95% CI 0.76-1.85)) or gender female (aOR 1.39 (95% CI 0.71-2.72)) and males (aOR 1.67 (95% CI 0.95-2.92)).","['patients were 44.9% female, 59.4% Black, 22.1% Hispanic, and 48.8% were ages 11-12\u202fyrs', 'group eligible adolescents who had already initiated the vaccine series']","['HPV vaccine', 'subsequent HPV vaccine']",['rates of vaccination'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.195873,"Adjusted analysis showed no difference between the groups (aOR 1.52 (95% CI 0.88-2.62)) or when examined by age (11-12yrs aOR 1.66, (95% CI 0.79-3.48)) and 13-17yrs (aOR 1.19, (95% CI 0.76-1.85)) or gender female (aOR 1.39 (95% CI 0.71-2.72)) and males (aOR 1.67 (95% CI 0.95-2.92)).","[{'ForeName': 'Tracey A', 'Initials': 'TA', 'LastName': 'Wilkinson', 'Affiliation': ""Indiana University School of Medicine, Department of Pediatrics-Children's Health Services Research, 410 W. 10th Street, Suite 2000, Indianapolis, IN 46202, United States. Electronic address: tracwilk@iu.edu.""}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Dixon', 'Affiliation': 'Indiana Univ, Fairbanks School of Public Health, Department of Epidemiology, 1050 Wishard Blvd, RG5, INpolis, IN 46202, United States; Regenstreif Institute, Center for Biomedical Informatics, 1101 W. 10th St., Indianapolis, IN 46202, United States. Electronic address: bedixon@regenstrief.org.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'Indiana University School of Medicine, Department of Biostatistics, 410 W. 10th St., Suite 3000, Indianapolis, IN 46202, United States.'}, {'ForeName': 'Wanzhu', 'Initials': 'W', 'LastName': 'Tu', 'Affiliation': 'Regenstreif Institute, Center for Biomedical Informatics, 1101 W. 10th St., Indianapolis, IN 46202, United States; Indiana University School of Medicine, Department of Biostatistics, 410 W. 10th St., Suite 3000, Indianapolis, IN 46202, United States. Electronic address: wtu1@iu.edu.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Lindsay', 'Affiliation': 'Center for Observational and Real-World Evidence, Merck & Co., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, United States. Electronic address: lindsabr@sas.upenn.edu.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Sheley', 'Affiliation': ""Indiana University School of Medicine, Department of Pediatrics-Children's Health Services Research, 410 W. 10th Street, Suite 2000, Indianapolis, IN 46202, United States. Electronic address: msheley@iu.edu.""}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Dugan', 'Affiliation': ""Indiana University School of Medicine, Department of Pediatrics-Children's Health Services Research, 410 W. 10th Street, Suite 2000, Indianapolis, IN 46202, United States. Electronic address: tmdugan@iu.edu.""}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Church', 'Affiliation': 'Regenstreif Institute, Center for Biomedical Informatics, 1101 W. 10th St., Indianapolis, IN 46202, United States. Electronic address: akchurch@iupui.edu.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Downs', 'Affiliation': ""Indiana University School of Medicine, Department of Pediatrics-Children's Health Services Research, 410 W. 10th Street, Suite 2000, Indianapolis, IN 46202, United States. Electronic address: stmdowns@iu.edu.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Zimet', 'Affiliation': 'Indiana Univ. School of Medicine, Dept. of Pediatrics-Adolescent Medicine, 410 W. 10th St., Suite 1001, Indianapolis, IN 46202, United States. Electronic address: gzimet@iu.edu.'}]",Vaccine,['10.1016/j.vaccine.2019.05.004']
1264,31227340,"Safety of radiofrequency ablation in patients with locally advanced, unresectable pancreatic cancer: A phase II study.","INTRODUCTION


Radiofrequency ablation (RFA) has been proposed as a new treatment option for locally advanced, unresectable pancreatic cancer (LAPC). In preparation of a randomized controlled trial (RCT), the aim of this phase II study was to assess the safety of RFA for patients with LAPC.
MATERIALS AND METHODS


Patients diagnosed with LAPC confirmed during surgical exploration between November 2012 and April 2014 were eligible for inclusion. RFA probes were placed under ultrasound guidance with a safety margin of at least 10 mm from the duodenum and 15 mm from the portomesenteric vessels. During RFA, the duodenum was continuously perfused with cold saline to reduce risk for thermal damage. Primary outcome was defined as the amount of major complications (Clavien-Dindo grade ≥III). RFA-related complications were predefined as: pancreatic fistula, pancreatitis, thermal damage to the portomesenteric vessels and duodenal perforation.
RESULTS


In total, 17 patients underwent RFA. Delayed gastric emptying (DGE) requiring endoscopic feeding tube placement occurred in 4 patients (24%) as only major complication. Five patients (29%) had a major complication other than DGE. One (6%) RFA-related major complications occurred. One patient (6%) died due to complications from a biliary leak following hepaticojejunostomy. After evaluation of the first 5 patients, gastrojejunostomy was no longer performed routinely. Since then severe DGE seemed to occur less (3/5 vs. 3/12 grade C DGE).
CONCLUSION


RFA is a major, but safe procedure for patients with LAPC if performed with strict predefined safety criteria. A RCT is currently investigating the true effectiveness of RFA in patients with LAPC.",2019,"RFA-related complications were predefined as: pancreatic fistula, pancreatitis, thermal damage to the portomesenteric vessels and duodenal perforation.
","['Patients diagnosed with LAPC confirmed during surgical exploration between November 2012 and April 2014 were eligible for inclusion', 'patients with LAPC', 'patients with locally advanced, unresectable pancreatic cancer', '17 patients underwent RFA', 'locally advanced, unresectable pancreatic cancer (LAPC']","['radiofrequency ablation', 'Radiofrequency ablation (RFA', 'cold saline', 'RFA']","['Delayed gastric emptying (DGE) requiring endoscopic feeding tube placement', 'safety of RFA', 'amount of major complications (Clavien-Dindo grade\u202f≥III']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0184899', 'cui_str': 'Exploratory incision (procedure)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C2945625', 'cui_str': 'Feeding tube, device (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",17.0,0.0477059,"RFA-related complications were predefined as: pancreatic fistula, pancreatitis, thermal damage to the portomesenteric vessels and duodenal perforation.
","[{'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Fegrachi', 'Affiliation': 'Departments of Surgery, University Medical Center Utrecht Cancer Center, St Antonius Hospital Nieuwegein, Regional Academic Cancer Center Utrecht, PO Box 85500, 3508 GA, Utrecht, the Netherlands.'}, {'ForeName': 'Marieke S', 'Initials': 'MS', 'LastName': 'Walma', 'Affiliation': 'Departments of Surgery, University Medical Center Utrecht Cancer Center, St Antonius Hospital Nieuwegein, Regional Academic Cancer Center Utrecht, PO Box 85500, 3508 GA, Utrecht, the Netherlands.'}, {'ForeName': 'Jan J J', 'Initials': 'JJJ', 'LastName': 'de Vries', 'Affiliation': 'Department of Radiology, Cancer Center Amsterdam, Amsterdam UMC, VU University, De Boelelaan 1117, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Hjalmar C', 'Initials': 'HC', 'LastName': 'van Santvoort', 'Affiliation': 'Departments of Surgery, University Medical Center Utrecht Cancer Center, St Antonius Hospital Nieuwegein, Regional Academic Cancer Center Utrecht, PO Box 85500, 3508 GA, Utrecht, the Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1100 DD, Amsterdam, the Netherlands.'}, {'ForeName': 'Erik G', 'Initials': 'EG', 'LastName': 'von Asmuth', 'Affiliation': 'Departments of Surgery, University Medical Center Utrecht Cancer Center, St Antonius Hospital Nieuwegein, Regional Academic Cancer Center Utrecht, PO Box 85500, 3508 GA, Utrecht, the Netherlands.'}, {'ForeName': 'Maarten S', 'Initials': 'MS', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht Cancer Center, University of Utrecht, PO Box 85500, 3508 GA, Utrecht, the Netherlands.'}, {'ForeName': 'Inne H', 'Initials': 'IH', 'LastName': 'Borel Rinkes', 'Affiliation': 'Departments of Surgery, University Medical Center Utrecht Cancer Center, St Antonius Hospital Nieuwegein, Regional Academic Cancer Center Utrecht, PO Box 85500, 3508 GA, Utrecht, the Netherlands.'}, {'ForeName': 'Rutger C', 'Initials': 'RC', 'LastName': 'Bruijnen', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht Cancer Center, University of Utrecht, PO Box 85500, 3508 GA, Utrecht, the Netherlands.'}, {'ForeName': 'Ignace H', 'Initials': 'IH', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands.'}, {'ForeName': 'Joost M', 'Initials': 'JM', 'LastName': 'Klaase', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the Netherlands.'}, {'ForeName': 'I Quintus', 'Initials': 'IQ', 'LastName': 'Molenaar', 'Affiliation': 'Departments of Surgery, University Medical Center Utrecht Cancer Center, St Antonius Hospital Nieuwegein, Regional Academic Cancer Center Utrecht, PO Box 85500, 3508 GA, Utrecht, the Netherlands.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'van Hillegersberg', 'Affiliation': 'Departments of Surgery, University Medical Center Utrecht Cancer Center, St Antonius Hospital Nieuwegein, Regional Academic Cancer Center Utrecht, PO Box 85500, 3508 GA, Utrecht, the Netherlands. Electronic address: r.vanhillegersberg@umcutrecht.nl.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2019.06.008']
1265,31274197,"A Multicenter, Randomized, Placebo-Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold.","This multicenter, double-blind, placebo-controlled, randomized study was designed to evaluate the efficacy and safety of pseudoephedrine hydrochloride 30-mg tablets in children aged 6 to 11 years for the temporary relief of nasal congestion due to the common cold. The primary efficacy end point was the weighted sum of the change from baseline in instantaneous nasal congestion severity score over the period from 1 to 8 hours following the first dose of study drug on day 1. Safety assessments included adverse events, sleepiness ratings, and vital signs. Pseudoephedrine was superior to placebo in reducing instantaneous nasal congestion severity in pediatric children over the first 8 hours after dosing on day 1 (least squares mean difference between treatment groups was 1.2; P = .029). Overall, secondary end points associated with nasal congestion were supportive on day 1, whereas secondary end points on day 2 were only numerically favorable. Somnolence was reported in a greater percentage of children on pseudoephedrine compared to placebo (71.9% vs 63.9%), while similar percentages of children in the same respective groups reported insomnia (34.4% and 38.9%) and nervousness (20.0% and 23.6%).Pseudoephedrine provides temporary relief of nasal congestion associated with the common cold in children 6 to <12 years of age at the current over-the-counter monograph dose. Multiple dosing of pseudoephedrine for up to 7 days, when given as needed for symptom relief, was generally safe in this population of children with the common cold.",2019,Pseudoephedrine was superior to placebo in reducing instantaneous nasal congestion severity in pediatric children over the first 8 hours after dosing on day 1 (least squares mean difference between treatment groups was 1.2; P = .029).,"['Children With the Common Cold', 'pediatric children', 'children aged 6 to 11\xa0years for the temporary relief of nasal congestion due to the common cold']","['23.6%).Pseudoephedrine', 'placebo', 'Placebo', 'pseudoephedrine', 'pseudoephedrine hydrochloride 30-mg tablets', 'Pseudoephedrine']","['instantaneous nasal congestion severity', 'nervousness', 'nasal congestion', 'adverse events, sleepiness ratings, and vital signs', 'insomnia', 'Somnolence', 'efficacy and safety', 'instantaneous nasal congestion severity score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033798', 'cui_str': 'Pseudoephedrine'}, {'cui': 'C2955048', 'cui_str': 'Pseudoephedrine Hydrochloride 30 MG [Sudafed]'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0518766'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}]",,0.25605,Pseudoephedrine was superior to placebo in reducing instantaneous nasal congestion severity in pediatric children over the first 8 hours after dosing on day 1 (least squares mean difference between treatment groups was 1.2; P = .029).,"[{'ForeName': 'Cathy K', 'Initials': 'CK', 'LastName': 'Gelotte', 'Affiliation': 'Johnson & Johnson Consumer, Inc, Fort Washington, PA, USA.'}, {'ForeName': 'Helmut H', 'Initials': 'HH', 'LastName': 'Albrecht', 'Affiliation': 'Department of Cellular Biology and Pharmacology, Herbert Wertheim College of Medicine, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hynson', 'Affiliation': 'Concentrics Research, Indianapolis, IN, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Gallagher', 'Affiliation': 'Perrigo Company, Allegan, MI, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1472']
1266,31260124,"The combined effect of tranilast 8% liposomal gel on the final cosmesis of acne scarring in patients concomitantly treated by isotretinoin: prospective, double-blind, split-face study.","BACKGROUND


Tranilast [N-(3,4-dimethoxycinnamoyl) anthranilic acid] has never been investigated for the prevention and treatment of acne scars.
AIM


To evaluate the efficacy and safety of tranilast 8% gel in improving the final appearance of patients with acne scarring concomitantly treated by isotretinoin.
METHODS


This was a prospective, double-blind, split-face study, which enrolled 40 otherwise healthy participants (aged 18-49 years) with facial acne scars. For each patient, one half of the face were treated with tranilast 8% liposomal gel and the other half with a water-based placebo. Using the Global Aesthetic Improvement Scale (GAIS), acne scars were evaluated by two dermatologists and by the patients, and the patients also rated their satisfaction with the treatment and reported adverse effects.
RESULTS


In total, 32 participants completed the trial. The mean GAIS scores at 5 months post-treatment were significantly lower (better outcome) for the tranilast-treated side than the placebo-treated areas in patients concomitantly treated with isotretinoin (P < 0.001). All the isotretinoin-treated patients reported greater satisfaction and better general improvement in the skin's appearance and texture, and also greater improvement of pigment and redness on the tranilast 8% gel-treated side compared with the control side.
CONCLUSION


Combined topical application of tranilast 8% gel twice daily with oral isotretinoin treatment in the active phase of acne vulgaris may result in fewer scars, finer skin texture and enhanced appearance.",2020,The mean GAIS scores at 5 months post-treatment were significantly lower (better outcome) for the tranilast-treated side than the placebo-treated areas in patients concomitantly treated with isotretinoin (P < 0.001).,"['patients with acne scarring concomitantly treated by isotretinoin', 'One-half of the faces of 40 healthy subjects (aged 18-49 years) with facial acne scars', 'patients concomitantly treated by isotretinoin', 'Thirty-two participants completed the trial']","['tranilast 8% liposomal gel', 'tranilast', 'tranilast 8% liposomal gel and the other half with an aqua-based placebo']","['pigmentary and redness alteration', 'side effects', 'final cosmesis of acne scarring', 'Acne scars', 'mean GAIS scores', 'efficacy and safety', 'Global Aesthetic Improvement Scale [GAIS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0423783', 'cui_str': 'Acne scar (disorder)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0146337', 'cui_str': 'tranilast'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0423783', 'cui_str': 'Acne scar (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0222045'}]",40.0,0.0583986,The mean GAIS scores at 5 months post-treatment were significantly lower (better outcome) for the tranilast-treated side than the placebo-treated areas in patients concomitantly treated with isotretinoin (P < 0.001).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Weinstein', 'Affiliation': 'Department of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': 'Department of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sprecher', 'Affiliation': 'Department of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Zur', 'Affiliation': 'Central Compounding Laboratory, Petah Tikva, Israel.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Mehrabi', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Artzi', 'Affiliation': 'Department of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}]",Clinical and experimental dermatology,['10.1111/ced.14032']
1267,31203100,Fatigue properties of removable partial denture clasps fabricated by selective laser melting followed by heat treatment.,"The aim of the study was to investigate the effect of post-heat treatment on the microstructures and fatigue strengths of Co-Cr-Mo (CCM) clasps prepared by selective laser melting (SLM). Clasp specimens and rod-shaped specimens were fabricated by SLM using CCM powders with different angulations (0°, 45°, and 90°). Two heat treatment conditions were used: 1 and 6 h at 1150 °C in an argon atmosphere followed by cooling in a furnace. Subsequently, the fatigue strength and microstructure were investigated. The results revealed that for the control group, the mean fatigue life was different when building angulations were changed as manifested by the control-90 specimen, which exhibited the highest fatigue life, followed by control-45 and then control-0. One-hour heat treated samples showed higher fatigue strength in all axes than the 0°- and 45°-axes control samples and lower fatigue strength than the 90°-axes control samples. The survival rate after heat treatment for 1 h exhibited no significant difference in all the axes. In terms of microstructure, after heat treatment, the samples showed homogeneous equiaxed grain and randomized texture in all angulations. Therefore, using a post-heat treatment can reduce the anisotropy effect on the microstructure and fatigue strength due to homogenized microstructure.",2019,One-hour heat treated samples showed higher fatigue strength in all axes than the 0°- and 45°-axes control samples and lower fatigue strength than the 90°-axes control samples.,[],['Co-Cr-Mo (CCM) clasps prepared by selective laser melting (SLM'],"['mean fatigue life', 'highest fatigue life', 'survival rate', 'fatigue strength']",[],"[{'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0137181,One-hour heat treated samples showed higher fatigue strength in all axes than the 0°- and 45°-axes control samples and lower fatigue strength than the 90°-axes control samples.,"[{'ForeName': 'Nuttaphon', 'Initials': 'N', 'LastName': 'Kittikundecha', 'Affiliation': 'Removable Partial Prosthodontics, Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Kajima', 'Affiliation': 'Removable Partial Prosthodontics, Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan; Department of Dental Materials, Nihon University School of Dentistry, 1-8-13 Kanda-Surugadai, Chiyoda-ku, Tokyo, 101-8310, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takaichi', 'Affiliation': 'Removable Partial Prosthodontics, Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan. Electronic address: a.takaichi.rpro@tmd.ac.jp.'}, {'ForeName': 'Hla Htoot', 'Initials': 'HH', 'LastName': 'Wai Cho', 'Affiliation': 'Removable Partial Prosthodontics, Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan.'}, {'ForeName': 'Hein Linn', 'Initials': 'HL', 'LastName': 'Htat', 'Affiliation': 'Removable Partial Prosthodontics, Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Doi', 'Affiliation': 'Metallic Biomaterials, Biomedical Materials, Institute of Biomaterials and Bioengineering, Tokyo Medical and Dental University, 2-3-10 Kanda-surugadai, Chiyoda-ku, Tokyo, 101-0062, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Oral Biomaterials Engineering, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Hanawa', 'Affiliation': 'Metallic Biomaterials, Biomedical Materials, Institute of Biomaterials and Bioengineering, Tokyo Medical and Dental University, 2-3-10 Kanda-surugadai, Chiyoda-ku, Tokyo, 101-0062, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Wakabayashi', 'Affiliation': 'Removable Partial Prosthodontics, Oral Health Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.06.010']
1268,31270429,Prevention of obesity in toddlers (PROBIT): a randomised clinical trial of responsive feeding promotion from birth to 24 months.,"INTRODUCTION


The aims of the PROBIT trial (clinicaltrials.gov: NCT03131284) were to prevent overweight or obesity occurring at two years of life, and improve feeding patterns during infancy.
METHODS


The trial compared 252 northern Italian newborns whose paediatricians offered their parents an educational programme from the child's birth to the age of two years (intervention arm) with 216 newborns whose parents did not undergo the programme (control arm). This sample size was 80% powerful to detect, with a 0.05 α error, a 40% lower prevalence of overweight/obesity and a 57% lower prevalence of obesity in the intervention arm. At each well visit, the parents of the children in the intervention arm were given oral and written information about protective behaviours, with particular emphasis on responsive feeding. Overweight and obesity at two years of age were, respectively, defined as a body mass index of more than the 85th and the 95th percentile in accordance with the WHO growth charts. The sample size had 80% power to detect a 40% lower prevalence of overweight/obesity and a 57% lower prevalence of obesity in the intervention arm.
RESULTS


At the age of two years, the prevalence of obesity in the intervention arm was 35% lower than among the controls, but the difference was not statistically significant (8.7% vs. 13.4%; p = 0.10) There was no difference in the prevalence of overweight/obesity between the groups (26.8% vs. 28.3%; p = 0.49). At the age of three months, a higher proportion of the infants in the intervention group were fed on demand (93% vs. 80%, p < 0.001).
CONCLUSIONS


The PROBIT trial failed to detect a significantly lower prevalence of obesity in the intervention arm, but did improve early feeding patterns. More powerful trials and meta-analyses are required to establish whether educating newborns' parents can decrease the prevalence of early obesity.",2019,"At the age of two years, the prevalence of obesity in the intervention arm was 35% lower than among the controls, but the difference was not statistically significant (8.7% vs. 13.4%; p = 0.10)","['Overweight and obesity at two years of age were, respectively, defined as a body mass index of more than the 85th and the 95th percentile in accordance with the WHO growth charts', 'obesity in toddlers (PROBIT', ""252 northern Italian newborns whose paediatricians offered their parents an educational programme from the child's birth to the age of two years (intervention arm) with 216 newborns whose parents did not undergo the programme (control arm""]",[],"['prevalence of obesity', 'prevalence of overweight/obesity']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C2718056', 'cui_str': 'Growth Charts'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0237433', 'cui_str': 'Pediatricians'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]",252.0,0.0318936,"At the age of two years, the prevalence of obesity in the intervention arm was 35% lower than among the controls, but the difference was not statistically significant (8.7% vs. 13.4%; p = 0.10)","[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Morandi', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Tommasi', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Soffiati', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Florinda', 'Initials': 'F', 'LastName': 'Destro', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Grando', 'Affiliation': 'Dolomiti Local Health and Social Care Service, Belluno, Italy.'}, {'ForeName': 'Giustina', 'Initials': 'G', 'LastName': 'Simonetti', 'Affiliation': 'Dolomiti Local Health and Social Care Service, Belluno, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Bucolo', 'Affiliation': 'Euganea Local Health and Social Care Service, Padua, Italy.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Alberti', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Baraldi', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Antonietta', 'Initials': 'A', 'LastName': 'Chiriacò', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Ferrarese', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Graziana', 'Initials': 'G', 'LastName': 'Frignani', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Pasqualini', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Rossi', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Siciliano', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Zuccolo', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Matticchio', 'Affiliation': 'Berica Local Health and Social Care Service, Vicenza, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Vettori', 'Affiliation': 'Berica Local Health and Social Care Service, Vicenza, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Danieli', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Guarda', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Iuliano', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raimo', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Sirpresi', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Trevisan', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Vinco', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Maffeis', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy. Claudio.maffeis@univr.it.'}]",International journal of obesity (2005),['10.1038/s41366-019-0406-0']
1269,31263017,Impact of audit and feedback with action implementation toolbox on improving ICU pain management: cluster-randomised controlled trial.,"BACKGROUND


Audit and feedback (A&F) enjoys widespread use, but often achieves only marginal improvements in care. Providing recipients of A&F with suggested actions to overcome barriers (action implementation toolbox) may increase effectiveness.
OBJECTIVE


To assess the impact of adding an action implementation toolbox to an electronic A&F intervention targeting quality of pain management in intensive care units (ICUs).
TRIAL DESIGN


Two-armed cluster-randomised controlled trial. Randomisation was computer generated, with allocation concealment by a researcher, unaffiliated with the study. Investigators were not blinded to the group assignment of an ICU.
PARTICIPANTS


Twenty-one Dutch ICUs and patients eligible for pain measurement.
INTERVENTIONS


Feedback-only versus feedback with action implementation toolbox.
OUTCOME


Proportion of patient-shift observations where pain management was adequate; composed by two process (measuring pain at least once per patient in each shift; re-measuring unacceptable pain scores within 1 hour) and two outcome indicators (acceptable pain scores; unacceptable pain scores normalised within 1 hour).
RESULTS


21 ICUs ( feedback-only  n=11;  feedback-with-toolbox  n=10) with a total of 253 530 patient-shift observations were analysed. We found absolute improvement on adequate pain management in the  feedback-with-toolbox  group (14.8%; 95% CI 14.0% to 15.5%) and the  feedback-only  group (4.8%; 95% CI 4.2% to 5.5%). Improvement was limited to the two process indicators. The  feedback-with-toolbox  group achieved larger effects than the  feedback-only  group both on the composite adequate pain management (p<0.05) and on measuring pain each shift (p<0.001). No important adverse effects have occurred.
CONCLUSION


Feedback with toolbox improved the number of shifts where patients received adequate pain management compared with feedback alone, but only in process and not outcome indicators.
TRIAL REGISTRATION NUMBER


NCT02922101.",2019,The  feedback-with-toolbox  group achieved larger effects than the  feedback-only  group both on the composite adequate pain management (p<0.05) and on measuring pain each shift (p<0.001).,"['intensive care units (ICUs', 'Twenty-one Dutch ICUs and patients eligible for pain measurement']","['Feedback-only versus feedback with action implementation toolbox', 'audit and feedback with action implementation toolbox', 'electronic A&F intervention']","['adequate pain management', 'ICU pain management', 'unacceptable pain scores', 'pain scores']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}]","[{'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.144539,The  feedback-with-toolbox  group achieved larger effects than the  feedback-only  group both on the composite adequate pain management (p<0.05) and on measuring pain each shift (p<0.001).,"[{'ForeName': 'Marie-José', 'Initials': 'MJ', 'LastName': 'Roos-Blom', 'Affiliation': 'Department of Medical Informatics, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands m.blom@amsterdamumc.nl.'}, {'ForeName': 'Wouter T', 'Initials': 'WT', 'LastName': 'Gude', 'Affiliation': 'Department of Medical Informatics, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Evert', 'Initials': 'E', 'LastName': 'de Jonge', 'Affiliation': 'National Intensive Care Evaluation (NICE) Foundation, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan Jaap', 'Initials': 'JJ', 'LastName': 'Spijkstra', 'Affiliation': 'National Intensive Care Evaluation (NICE) Foundation, Amsterdam, The Netherlands.'}, {'ForeName': 'Sabine N', 'Initials': 'SN', 'LastName': 'van der Veer', 'Affiliation': 'Centre for Health Informatics, Division of Informatics, Imaging and Data Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Peek', 'Affiliation': 'Centre for Health Informatics, Division of Informatics, Imaging and Data Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Dave A', 'Initials': 'DA', 'LastName': 'Dongelmans', 'Affiliation': 'National Intensive Care Evaluation (NICE) Foundation, Amsterdam, The Netherlands.'}, {'ForeName': 'Nicolette F', 'Initials': 'NF', 'LastName': 'de Keizer', 'Affiliation': 'Department of Medical Informatics, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",BMJ quality & safety,['10.1136/bmjqs-2019-009588']
1270,31046165,Day clinic vs. hospital care of pneumonia and severe malnutrition in children under five: a randomised trial.,"OBJECTIVES


To evaluate the clinical outcomes and costs of managing pneumonia and severe malnutrition in a day clinic (DC) management model (outpatient) vs. hospital care (inpatient).
METHODS


Randomised clinical trial where children aged 2 months to 5 years with pneumonia and severe malnutrition were randomly allocated to DC or inpatient hospital care. We used block randomisation of variable length from 8 to 20 and produced computer-generated random numbers that were assigned to one of the two interventions. Successful management was defined as resolution of clinical signs of pneumonia and being discharged from the model of care (DC or hospital) without need for referral to a hospital (DC), or referral to another hospital. All the children in both DC and hospital received intramuscular ceftriaxone, daily nutrition support and micronutrients.
RESULTS


Four hundred and seventy children were randomly assigned to either DC or hospital care. Successful management was achieved for 184 of 235 (78.3%) by DC alone, vs. 201 of 235 (85.5%) by hospital inpatient care [RR (95% CI) = 0.79 (0.65-0.97), P = 0.02]. During 6 months of follow-up, 30/235 (12.8%) in the DC group and 36/235 (15.3%) required readmission to hospital in the hospital care group [RR (95% CI) = 0.89 (0.67-1.18), P = 0.21]. The average overall healthcare and societal cost was 34% lower in DC (US$ 188 ± 11.7) than in hospital (US$ 285 ± 13.6) (P < 0.001), and costs for households were 33% lower.
CONCLUSIONS


There was a 7% greater probability of successful management of pneumonia and severe malnutrition when inpatient hospital care rather than the outpatient day clinic care was the initial method of care. However, where timely referral mechanisms were in place, 94% of children with pneumonia and severe malnutrition were successfully managed initially in a day clinic, and costs were substantially lower than with hospital admission.",2019,"Successful management was achieved for 184 of 235 (78.3%) by DC alone, vs. 201 of 235 (85.5%) by hospital inpatient care [RR (95% CI) = 0.79 (","['Four hundred and seventy children', 'managing pneumonia and severe malnutrition in a day clinic (DC) management model (outpatient) vs. hospital care (inpatient', 'Day clinic vs. hospital care of pneumonia and severe malnutrition in children under five', 'children aged 2\xa0months to 5\xa0years with pneumonia and severe malnutrition']","['DC or inpatient hospital care', 'ceftriaxone, daily nutrition support and micronutrients', 'DC or hospital care']","['readmission to hospital', 'Successful management', 'average overall healthcare and societal cost', 'probability of successful management of pneumonia and severe malnutrition', 'hospital inpatient care [RR']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient (finding)'}]",470.0,0.130612,"Successful management was achieved for 184 of 235 (78.3%) by DC alone, vs. 201 of 235 (85.5%) by hospital inpatient care [RR (95% CI) = 0.79 (","[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Ashraf', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Nur H', 'Initials': 'NH', 'LastName': 'Alam', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Marufa', 'Initials': 'M', 'LastName': 'Sultana', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Selina A', 'Initials': 'SA', 'LastName': 'Jahan', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Nurshad', 'Initials': 'N', 'LastName': 'Begum', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Sharmin', 'Initials': 'S', 'LastName': 'Farzana', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Mohammod J', 'Initials': 'MJ', 'LastName': 'Chisti', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Mohiuddin', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Radda Maternal and Child Health Family Planning Centre, Dhaka, Bangladesh.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Shamsuzzaman', 'Affiliation': 'Institute of Child Health and Shishu, Sasthya Foundation Hospital, Dhaka, Bangladesh.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'Jahangir A M', 'Initials': 'JAM', 'LastName': 'Khan', 'Affiliation': 'icddr,b, International Centre for Diarrhoeal Disease Research, Bangladesh.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Fuchs', 'Affiliation': 'Department of Pediatrics, University of Kentucky College of Medicine, Lexington, Kentucky, USA.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Duke', 'Affiliation': 'Centre for International Child Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Niklaus', 'Initials': 'N', 'LastName': 'Gyr', 'Affiliation': 'Faculty of Medicine, University of Basel, Basel, Switzerland.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13242']
1271,31249252,Effect of different doses of intrathecal dexmedetomidine on hemodynamic parameters and block characteristics after ropivacaine spinal anesthesia in lower-limb orthopedic surgery: a randomized clinical trial.,"The study aims to compare the efficacy of different doses of intrathecal dexmedetomidine on hemodynamic parameters and block characteristics after ropivacaine spinal anesthesia in lower-limb orthopedic surgery. In a double-blind trial, 90 patients undergoing spinal anesthesia for lower-limb orthopedic surgery were included and then randomly assigned to three groups; dexmedetomidine 5 μg/kg, dexmedetomidine 10 μg/kg and placebo. Blood pressure, heart rate, and oxygen saturation were recorded in the three groups at the first 15 minutes and then every 15 to 180 minutes at recovery by a resident anesthesiologist, as well as sensory-motor block onset. The visual analog scale scores for the assessment of pain were recorded at recovery, and 2, 4, 6, and 12 hours postoperatively and the data were analyzed by Stata software. The onset and time to achieve sensory block to ≥ T8 were faster in the 10 μg/kg dexmedetomidine group than the other groups (P = 0.001). The Bromage score was higher in the 10 μg/kg dexmedetomidine group (P = 0.0001) with lower pain score as compared with the 5 μg/kg dexmedetomidine and placebo groups (P = 0.0001). Therefore, an increase in dexmedetomidine hastens the onset of sensory-motor block but not causes side effects. This study was approved by the Ethical Committee of Arak University of Medical Sciences in 2017 (Ethical Code: IR.ARAKMU.REC.1396.37), and the trail was registered and approved by the Iranian Registry of Clinical Trials in 2017 (IRCT No. IRCT2017070614056N12).",2019,The Bromage score was higher in the 10 μg/kg dexmedetomidine group (P = 0.0001) with lower pain score as compared with the 5 μg/kg dexmedetomidine and placebo groups (P = 0.0001).,"['lower-limb orthopedic surgery', '90 patients undergoing spinal anesthesia for lower-limb orthopedic surgery']","['placebo', 'ropivacaine spinal anesthesia', 'dexmedetomidine 5 μg/kg, dexmedetomidine 10 μg/kg and placebo', 'dexmedetomidine', 'intrathecal dexmedetomidine']","['Blood pressure, heart rate, and oxygen saturation', 'visual analog scale scores', 'hemodynamic parameters and block characteristics', 'pain score']","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",90.0,0.434794,The Bromage score was higher in the 10 μg/kg dexmedetomidine group (P = 0.0001) with lower pain score as compared with the 5 μg/kg dexmedetomidine and placebo groups (P = 0.0001).,"[{'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Farokhmehr', 'Affiliation': 'Student Research Committee, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Hesameddin', 'Initials': 'H', 'LastName': 'Modir', 'Affiliation': 'Departments of Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Yazdi', 'Affiliation': 'Departments of Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Kamali', 'Affiliation': 'Departments of Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Almasi-Hashiani', 'Affiliation': 'Department of Epidemiology, School of Health; Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Arak, Iran.'}]",Medical gas research,['10.4103/2045-9912.260645']
1272,31249394,Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma.,"BACKGROUND


Proteinuria monitoring is required in patients receiving lenvatinib, however, current methodology involves burdensome overnight urine collection.
METHODS


To determine whether the simpler urine protein:creatinine ratio (UPCR) calculated from spot urine samples could be accurately used for proteinuria monitoring in patients receiving lenvatinib, we evaluated the correlation between UPCR and 24-hour urine protein results from the phase 3 REFLECT study. Paired data (323 tests, 154 patients) were analysed.
RESULTS


Regression analysis showed a statistically significant correlation between UPCR and 24-hour urine protein (R 2 : 0.75; P < 2 × 10 -16 ). A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria. Using this UPCR cut-off value to determine the need for further testing could reduce the need for 24-hour urine collection in ~74% of patients.
CONCLUSION


Incorporation of UPCR into the current algorithm for proteinuria management can enable optimisation of lenvatinib treatment, while minimising patient inconvenience.
CLINICAL TRIAL REGISTRATION


NCT01761266.",2019,"A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria.",['hepatocellular carcinoma'],['lenvatinib vs sorafenib'],['UPCR and 24-hour urine protein'],"[{'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1305628', 'cui_str': 'Urine protein (substance)'}]",,0.0399609,"A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria.","[{'ForeName': 'Thomas R Jeffry', 'Initials': 'TRJ', 'LastName': 'Evans', 'Affiliation': 'University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK. j.evans@beatson.gla.ac.uk.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'David Geffen School of Medicine, UCLA Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Kwang-Hyub', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Severance Hospital, Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Silvija', 'Initials': 'S', 'LastName': 'Kraljevic', 'Affiliation': 'Former employee of Eisai Ltd, Hatfield, UK.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Corina E', 'Initials': 'CE', 'LastName': 'Dutcus', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Piscaglia', 'Affiliation': 'Unit of Internal Medicine, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Max W', 'Initials': 'MW', 'LastName': 'Sung', 'Affiliation': 'Tisch Cancer Institute at Mount Sinai, New York, NY, USA.'}]",British journal of cancer,['10.1038/s41416-019-0506-6']
1273,31247660,[French comment on article Impact of a 1-day versus 3-day low-residue diet on bowel cleansing quality before colonoscopy: a randomized controlled trial].,,2019,,[],['1-day versus 3-day low-residue diet'],['bowel cleansing quality'],[],"[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0425404', 'cui_str': 'Low residue diet (finding)'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0765515,,[],Endoscopy,['10.1055/a-0942-8045']
1274,31255591,Evaluation of integrated interventions layered on mass drug administration for urogenital schistosomiasis elimination: a cluster-randomised trial.,"BACKGROUND


Elimination of schistosomiasis as a public health problem and interruption of transmission in selected areas are targets set by WHO for 2025. Our aim was to assess biannual mass drug administration (MDA) applied alone or with complementary snail control or behaviour change interventions for the reduction of Schistosoma haematobium prevalence and infection intensity in children from Zanzibar and to compare the effect between the clusters.
METHODS


In a 5-year repeated cross-sectional cluster-randomised trial, 90 shehias (small administrative regions; clusters) in Zanzibar eligible owing to available natural open freshwater bodies and public primary schools were randomly allocated (ratio 1:1:1) to receive one of three interventions: biannual MDA with praziquantel alone (arm 1) or in combination with snail control (arm 2), or behaviour change activities (arm 3). Neither participants nor field or laboratory personnel were blinded to the intervention arms. From 2012 to 2017, annually, a single urine sample was collected from approximately 100 children aged 9-12 years in the main public primary school of each shehia. The primary outcome was S haematobium infection prevalence and intensity in 9-12-year-old children after 5 years of follow-up. This study is completed and was registered with the ISRCTN, number 48837681.
FINDINGS


The trial was done from Nov 1, 2011, through to Dec 31, 2017 and recruitment took place from Nov 2, 2011, until May 17, 2017. At baseline we enrolled 8278 participants, of whom 2899 (35%) were randomly allocated to arm 1, 2741 (33%) to arm 2, and 2638 (32%) to arm 3. 120 (4·2%) of 2853 in arm 1, 209 (7·8%) of 2688 in arm 2, and 167 (6·4%) of 2613 in arm 3 had S haematobium infections at baseline. Heavy infections (≥50 eggs per 10 mL of urine) were found in 126 (1·6%) of 8073 children at baseline. At the 5-year endline survey, 46 (1·4%) of 3184 in arm 1, 56 (1·7%) of 3217 (odds ratio [OR] 1·2 [95% CI 0·6-2·7] vs arm 1) in arm 2, and 58 (1·9%) of 3080 (1·3 [0·6-2·9]) in arm 3 had S haematobium infections. Heavy infections were detected in 33 (0·3%) of 9462 children.
INTERPRETATION


Biannual MDA substantially reduced the S haematobium prevalence and infection intensity but was insufficient to interrupt transmission. Although snail control or behaviour change activities did not significantly boost the effect of MDA in our study, they might enhance interruption of transmission when tailored to focal endemicity and applied for a longer period. It is now necessary to focus on reducing prevalence in remaining hotspot areas and to introduce new methods of surveillance and public health response so that the important gains can be maintained and advanced.
FUNDING


University of Georgia Research Foundation Inc and Bill & Melinda Gates Foundation.",2019,Heavy infections (≥50 eggs per 10 mL of urine) were found in 126 (1·6%) of 8073 children at baseline.,"['8278 participants, of whom 2899 (35', 'From 2012 to 2017, annually, a single urine sample was collected from approximately 100 children aged 9-12 years in the main public primary school of each shehia', '1·2', '90 shehias (small administrative regions; clusters) in Zanzibar eligible owing to available natural open freshwater bodies and public primary schools', 'urogenital schistosomiasis elimination', 'Neither participants nor field or laboratory personnel']","['biannual mass drug administration (MDA) applied alone or with complementary snail control or behaviour change interventions', 'biannual MDA with praziquantel alone (arm 1) or in combination with snail control (arm 2), or behaviour change activities']","['S haematobium infections', 'Heavy infections', 'Schistosoma haematobium prevalence and infection intensity', 'S haematobium infection prevalence and intensity']","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205959', 'cui_str': 'Zanzibar'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0016710', 'cui_str': 'Freshwater'}, {'cui': 'C1704430', 'cui_str': 'Urinary Schistosomiasis'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C3178774', 'cui_str': 'Laboratory Personnel'}]","[{'cui': 'C4505223', 'cui_str': 'Mass Drug Administration'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C3853310', 'cui_str': 'Snail'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0036316', 'cui_str': 'Schistosoma haematobiums'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",8278.0,0.290061,Heavy infections (≥50 eggs per 10 mL of urine) were found in 126 (1·6%) of 8073 children at baseline.,"[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Knopp', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland; Wolfson Wellcome Biomedical Laboratories, Department of Life Sciences, Natural History Museum, London, UK. Electronic address: s.knopp@swisstph.ch.'}, {'ForeName': 'Bobbie', 'Initials': 'B', 'LastName': 'Person', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Shaali M', 'Initials': 'SM', 'LastName': 'Ame', 'Affiliation': 'Public Health Laboratory-Ivo de Carneri, Pemba, Tanzania.'}, {'ForeName': 'Said M', 'Initials': 'SM', 'LastName': 'Ali', 'Affiliation': 'Public Health Laboratory-Ivo de Carneri, Pemba, Tanzania.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hattendorf', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Juma', 'Affiliation': 'Public Health Laboratory-Ivo de Carneri, Pemba, Tanzania.'}, {'ForeName': 'Juma', 'Initials': 'J', 'LastName': 'Muhsin', 'Affiliation': 'Neglected Diseases Programme, Ministry of Health, Zanzibar, Tanzania.'}, {'ForeName': 'Iddi S', 'Initials': 'IS', 'LastName': 'Khamis', 'Affiliation': 'Neglected Diseases Programme, Ministry of Health, Zanzibar, Tanzania.'}, {'ForeName': 'Khalfan A', 'Initials': 'KA', 'LastName': 'Mohammed', 'Affiliation': 'Neglected Diseases Programme, Ministry of Health, Zanzibar, Tanzania.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Utzinger', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hollenberg', 'Affiliation': 'Schistosomiasis Control Initiative, Department of Infectious Disease Epidemiology, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Kabole', 'Affiliation': 'Neglected Diseases Programme, Ministry of Health, Zanzibar, Tanzania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rollinson', 'Affiliation': 'Wolfson Wellcome Biomedical Laboratories, Department of Life Sciences, Natural History Museum, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30189-5']
1275,31251694,Cost Effectiveness of Interval Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer on the Basis of a Randomized Phase III Trial.,"PURPOSE


In the randomized open-label phase III OVHIPEC trial, the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery (CRS) improved recurrence-free and overall survival in patients with stage III ovarian cancer. We studied the cost effectiveness of the addition of HIPEC to interval CRS in patients with ovarian cancer.
PATIENTS AND METHODS


We constructed a Markov health-state transition model to measure costs and clinical outcomes. Transition probabilities were derived from the OVHIPEC trial by fitting survival distributions. Incremental cost-effectiveness ratio (ICER), expressed as euros per quality-adjusted life-year (QALY), was calculated from a Dutch societal perspective, with a time horizon of 10 years. Univariable and probabilistic sensitivity analyses were conducted to evaluate the decision uncertainty.
RESULTS


Total health care costs were €70,046 (95% credibility interval [CrI], €64,016 to €76,661) for interval CRS compared with €85,791 (95% CrI, €78,766 to €93,935) for interval CRS plus HIPEC. The mean QALY in the interval CRS group was 2.12 (95% CrI, 1.66 to 2.64 QALYs) and 2.68 (95% CrI, 2.11 to 3.28 QALYs) in the interval CRS plus HIPEC group. The ICER amounted to €28,299/QALY. In univariable sensitivity analysis, the utility of recurrence-free survival and the number of days in the hospital affected the calculated ICER most.
CONCLUSION


On the basis of the trial data, treatment with interval CRS and HIPEC in patients with stage III ovarian cancer was accompanied by a substantial gain in QALYs. The ICER is below the willingness-to-pay threshold in the Netherlands, indicating interval CRS and HIPEC is cost effective for this patient population. These results lend additional support for reimbursing the costs of treating these patients with interval CRS and HIPEC in countries with comparable health care systems.",2019,"The mean QALY in the interval CRS group was 2.12 (95% CrI, 1.66 to 2.64 QALYs) and 2.68 (95% CrI, 2.11 to 3.28 QALYs) in the interval CRS plus HIPEC group.","['patients with stage III ovarian cancer', 'Stage III Ovarian Cancer', 'patients with ovarian cancer']","['interval CRS and HIPEC', 'Interval Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy', 'HIPEC to interval CRS', 'hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery (CRS']","['interval CRS', 'utility of recurrence-free survival', 'Transition probabilities', 'mean QALY', 'Incremental cost-effectiveness ratio (ICER), expressed as euros per quality-adjusted life-year (QALY', 'Total health care costs', 'recurrence-free and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.207322,"The mean QALY in the interval CRS group was 2.12 (95% CrI, 1.66 to 2.64 QALYs) and 2.68 (95% CrI, 2.11 to 3.28 QALYs) in the interval CRS plus HIPEC group.","[{'ForeName': 'Simone N', 'Initials': 'SN', 'LastName': 'Koole', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'van Lieshout', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Willemien J', 'Initials': 'WJ', 'LastName': 'van Driel', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Evi', 'Initials': 'E', 'LastName': 'van Schagen', 'Affiliation': '6Erasmus University Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Sikorska', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Jacobien M', 'Initials': 'JM', 'LastName': 'Kieffer', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Jules H', 'Initials': 'JH', 'LastName': 'Schagen van Leeuwen', 'Affiliation': '7St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Henk W R', 'Initials': 'HWR', 'LastName': 'Schreuder', 'Affiliation': '8UMC Utrecht Cancer Center, Utrecht, the Netherlands.'}, {'ForeName': 'Ralph H', 'Initials': 'RH', 'LastName': 'Hermans', 'Affiliation': '9Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Ignace H', 'Initials': 'IH', 'LastName': 'de Hingh', 'Affiliation': '5The Dutch Peritoneal Oncology Group, Eindhoven, the Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'van der Velden', 'Affiliation': '2Center for Gynecologic Oncology Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Henriette J', 'Initials': 'HJ', 'LastName': 'Arts', 'Affiliation': '11University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Leon F A G', 'Initials': 'LFAG', 'LastName': 'Massuger', 'Affiliation': '12Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Arend G', 'Initials': 'AG', 'LastName': 'Aalbers', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'Verwaal', 'Affiliation': '13Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Koen K', 'Initials': 'KK', 'LastName': 'Van de Vijver', 'Affiliation': '14University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Aaronson', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'van Tinteren', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Gabe S', 'Initials': 'GS', 'LastName': 'Sonke', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Harten', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Valesca P', 'Initials': 'VP', 'LastName': 'Retèl', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00594']
1276,31248711,"Less Postoperative Restrictions Following Total Hip Arthroplasty With Use of a Posterolateral Approach: A Prospective, Randomized, Noninferiority Trial.","BACKGROUND


Patient restrictions are prescribed after total hip arthroplasty (THA) to ensure proper healing and prevent early dislocation. It has been suggested that less or nonrestrictive protocols following THA do not lead to higher dislocation rates. Nonetheless, restrictions are still widely used. The aim of this study is to evaluate the rate of early dislocations when patients were restricted to supine sleeping or unrestricted sleeping in the first 8 weeks after THA using a posterolateral approach.
METHODS


The study design was a single-center, parallel-group, stratified, randomized, noninferiority trial in which primary THA patients were allocated to either a restricted group or a nonrestricted group. The primary outcome was early (<8 weeks) dislocation rate. Secondary outcomes include pain (visual analog scale [VAS]), function in activities of daily living (Hip Disability and Osteoarthritis Outcome Score [HOOS]), and quality of life (EuroQoL 5 Dimension [EQ-5D]).
RESULTS


A total of 408 patients were randomized into 2 groups: those who were restricted in their sleeping position (n = 203) and those who received no restrictions in sleeping position (n = 205). Three patients (1.48%) from the restricted group and 3 patients (1.46%) from the unrestricted group had a dislocation. The noninferiority of the restricted group compared to the nonrestricted group was established for early dislocation. In addition, no statistically significant differences were found for VAS, HOOS, and QoL-5D between both groups. Both groups showed a significant improvement in VAS, HOOS, and QoL-5D.
CONCLUSION


Early dislocation rates in patients who were advised to comply to an unrestricted sleeping position following THA were not inferior to the dislocation rates in patients who were advised to sleep in a supine position following THA. The results of the present study strengthen the discussion regarding the relevance of providing patients with restrictions following THA.",2019,"In addition, no statistically significant differences were found for VAS, HOOS, and QoL-5D between both groups.","['primary THA patients', '408 patients were randomized into 2 groups: those who were restricted in their sleeping position (n\xa0= 203) and those who received']","['no restrictions in sleeping position', 'Total Hip Arthroplasty', 'total hip arthroplasty (THA']","['dislocation', 'dislocation rate', 'VAS, HOOS, and QoL-5D', 'pain (visual analog scale [VAS]), function in activities of daily living (Hip Disability and Osteoarthritis Outcome Score [HOOS]), and quality of life (EuroQoL 5 Dimension [EQ-5D', 'rate of early dislocations', 'VAS, HOOS, and QoL-5D.\nCONCLUSION\n\n\nEarly dislocation rates']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}]","[{'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C2960679', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",408.0,0.0966435,"In addition, no statistically significant differences were found for VAS, HOOS, and QoL-5D between both groups.","[{'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'OCON Centre for Orthopaedic Surgery, Hip Unit, Hengelo, the Netherlands.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Ter Weele', 'Affiliation': 'OCON Centre for Orthopaedic Surgery, Hip Unit, Hengelo, the Netherlands.'}, {'ForeName': 'Fokko', 'Initials': 'F', 'LastName': 'Manning', 'Affiliation': 'OCON Centre for Orthopaedic Surgery, Hip Unit, Hengelo, the Netherlands.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Tijink', 'Affiliation': 'OCON Centre for Orthopaedic Surgery, Hip Unit, Hengelo, the Netherlands.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Pakvis', 'Affiliation': 'OCON Centre for Orthopaedic Surgery, Hip Unit, Hengelo, the Netherlands.'}, {'ForeName': 'Rianne', 'Initials': 'R', 'LastName': 'Huis In Het Veld', 'Affiliation': 'OCON Centre for Orthopaedic Surgery, Hip Unit, Hengelo, the Netherlands.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.05.038']
1277,31253489,An on-line support tool to reduce exercise-related hypoglycaemia and improve confidence to exercise in type 1 diabetes.,"OBJECTIVE


Hypoglycaemia related to exercise and lack of confidence to exercise, are common in T1DM. An online educational exercise tool (ExT1D) was tested to determine whether these parameters can be improved.
RESEARCH DESIGN AND METHODS


Thirty two adults with T1DM (50%M, age 35.8 ± 9.5 yr diabetes duration 12.3 ± 9.9 yr, median HbA1c 7.1%[ICR 6.4-7.7] NGSPU) exercising ≥ 60 min/week enrolled in a RCT utilising ExT1D, with partial cross-over design. The primary end-point was Exercise-related hypoglycaemia (ErH) number corrected for exercise session number, with ErH defined as CGM episodes < 4.0 mM occurring within 24 h of exercise. Secondary RCT endpoints were total ErH duration, and ErH duration/episode. A pre-defined longitudinal analysis with each subject compared with their baseline was also undertaken, for the three ErH parameters, and using fear of hypoglycaemia questionnaires.
RESEARCH


In the RCT a 50% lower median ErH number (P = 0.6) (37% lower ErH number per exercise session (P = 0.06, NS primary endpoint) occurred in the Intervention vs Control group. A 49% lower ErH duration per episode (P = 0.2), and 80% less ErH duration (P = 0.3), were also observed in the Intervention vs Control group. In the longitudinal study, ErH number reduced by 43% (P = 0.088), ErH duration per episode by 52% (P = 0.157) and total duration of ErH fell by 71% (P = 0.015). Confidence to prevent glucose lowering by exercise also improved (P = 0.039). Post-hoc analysis showed those with the greatest ErH events at baseline benefited most. Fructosamine and HbA1c levels were unchanged from baseline.
CONCLUSIONS


ExT1D can reduce exercise-related hypoglycaemia and provide greater confidence to exercise.",2019,"In the RCT a 50% lower median ErH number (P = 0.6) (37% lower ErH number per exercise session (P = 0.06, NS primary endpoint) occurred in the Intervention vs Control group.","['Thirty two adults with T1DM (50%M, age 35.8\u202f±\u202f9.5\u202fyr diabetes duration 12.3\u202f±\u202f9.9\u202fyr']",['online educational exercise tool (ExT1D'],"['Exercise-related hypoglycaemia (ErH) number corrected for exercise session number, with ErH defined as CGM episodes', 'median ErH number', 'total duration of ErH fell', 'ErH duration per episode', 'ErH duration', 'Fructosamine and HbA1c levels', 'median HbA1c', 'total ErH duration, and ErH duration/episode']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0060765', 'cui_str': 'D-Isoglucosamine'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",32.0,0.0995456,"In the RCT a 50% lower median ErH number (P = 0.6) (37% lower ErH number per exercise session (P = 0.06, NS primary endpoint) occurred in the Intervention vs Control group.","[{'ForeName': 'Agata K', 'Initials': 'AK', 'LastName': 'Piotrowicz', 'Affiliation': 'Diabetes Centre, Department of Endocrinology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'McGill', 'Affiliation': 'Diabetes Centre, Department of Endocrinology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Overland', 'Affiliation': 'Diabetes Centre, Department of Endocrinology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Molyneaux', 'Affiliation': 'Diabetes Centre, Department of Endocrinology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia; Faculty of Health Sciences, The University of Sydney, Sydney, NSW 2006, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Twigg', 'Affiliation': 'Diabetes Centre, Department of Endocrinology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia. Electronic address: Stephen.twigg@sydney.edu.au.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.05.011']
1278,31084375,Will Stone Density Stop Being a Key Factor in Endourology? The Impact of Stone Density on Laser Time Using Lumenis Laser p120w and Standard 20 W Laser: A Comparative Study.,"Introduction and Objectives:  Ureteroscopy is the gold standard for most urinary tract calculi. Our institute recently incorporated a powerful 120 W holmium laser machine integrating innovative technology (Lumenis ®  MOSES Pulse TM 120H Holmium:YAG laser; Lumenis Ltd.). In this retrospective comparative study, we evaluated the influence of stone density on laser dusting time in a high-power 120 W laser machine  vs  a standard 20 W machine (Dornier Medilas ®  H20 Holmium:YAG laser; Dornier Ltd.)  Methods:  We conducted a retrospective review of medical records of patients who underwent ureteroscopy during the years 2013-2018 for a solitary stone. Stone and clinical characteristics, among other parameters, have been evaluated, including the total laser time until complete stone dusting.  Results:  Among 631 eligible patients, 462 were treated with a 20 W standard laser and 169 patients with a p120w laser machine. Overall laser time was less than half with p120w laser  vs  d20w (195 seconds  vs  397.14 seconds,  p -value <0.001). Multivariate regression demonstrated 234.91 seconds shorter laser time with a p120w laser while controlling confounders such as stone volume, hydronephrosis, and location ( p  value <0.0001). This pattern was demonstrated in all stone densities. The association between laser dusting time per stone volume and stone density demonstrated relatively constant laser time when using p120w laser, even for hard stones. When the standard 20 W laser was used, laser time was longer in each stone density. Moreover, a stone density of 1164 HU and more demonstrated an upward shift of laser time to stone density curve in standard d20w laser group only.  Conclusions:  Time to complete stone dusting using p120w laser is extremely shorter, approximately half, comparing with the standard 20 W laser. This pattern is robust and even exponential when evaluating laser time per stone density, especially in hard stones. A new horizon of powerful innovative laser technology will enable to improve endourology practice and patients' care.",2019,"Multivariate regression demonstrated 234.91 seconds shorter laser time with a p120w laser while controlling confounders such as stone volume, hydronephrosis, and location ( p  value <0.0001).","['631 eligible patients, 462 were treated with a 20 W standard laser and 169 patients with a p120w laser machine', 'patients who underwent ureteroscopy during the years 2013-2018 for a solitary stone']","['Ureteroscopy', 'high-power 120 W laser machine  vs  a standard 20 W machine (Dornier Medilas ®  H20 Holmium:YAG laser', 'Lumenis Laser p120w and Standard 20 W Laser']","['Stone Density on Laser Time', 'Overall laser time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}]","[{'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019846', 'cui_str': 'Holmium'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}]","[{'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",631.0,0.0180567,"Multivariate regression demonstrated 234.91 seconds shorter laser time with a p120w laser while controlling confounders such as stone volume, hydronephrosis, and location ( p  value <0.0001).","[{'ForeName': 'Matan', 'Initials': 'M', 'LastName': 'Mekayten', 'Affiliation': '1 Urology Department, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Amitay', 'Initials': 'A', 'LastName': 'Lorber', 'Affiliation': '1 Urology Department, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Katafigiotis', 'Affiliation': '2 1st University Urology Clinic, Laiko Hospital, Athens, Greece.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Sfoungaristos', 'Affiliation': '3 1st Department of Urology, G. Gennimatas Hospital, Aristotle University, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Leotsakos', 'Affiliation': '1 Urology Department, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Eliyahu Meir', 'Initials': 'EM', 'LastName': 'Heifetz', 'Affiliation': '4 Jerusalem College of Technology, Jerusalem, Israel.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Yutkin', 'Affiliation': '1 Urology Department, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Ofer Nathan', 'Initials': 'ON', 'LastName': 'Gofrit', 'Affiliation': '1 Urology Department, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Mordechai', 'Initials': 'M', 'LastName': 'Duvdevani', 'Affiliation': '1 Urology Department, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}]",Journal of endourology,['10.1089/end.2019.0181']
1279,31090673,Firefighting Induces Acute Inflammatory Responses that are not Relieved by Aspirin in Older Firefighters.,"OBJECTIVE


Sudden cardiac events account for 40% to 50% of firefighter line-of-duty deaths. Inflammatory proteins are strong biomarkers of cardiovascular inflammation. The present study investigated the effects of aspirin supplementation on inflammatory biomarkers following firefighting.
METHODS


Using a randomized, placebo-controlled, double-blind crossover design, 24 male firefighters (48.2 ± 5.9 years) were allocated into four conditions: acute (81 mg; single-dose) aspirin and placebo supplementation, and chronic (81 mg; 14 days) aspirin and placebo supplementation. Inflammatory proteins [interleukin (IL)-6, C-reactive protein (CRP), intracellular adhesion molecule (ICAM)-1, P-selectin, matrix metalloproteinase-9 (MMP-9)] and antioxidant potential [total antioxidant capacity (TAC)] were measured pre- and post-structural firefighting drills.
RESULTS


Firefighting activities significantly increased IL-6, MMP-9, and P-Selectin; however, no changes in TAC and ICAM-1 were detected. Neither acute nor chronic aspirin supplementation attenuated this inflammatory response.
CONCLUSION


Firefighting significantly increases inflammatory biomarkers and neither acute nor chronic low-dose aspirin mitigates this response.",2019,"RESULTS


Firefighting activities significantly increased IL-6, MMP-9, and P-Selectin; however, no changes in TAC and ICAM-1 were detected.","['24 male firefighters (48.2\u200a±\u200a5.9 years', 'Older Firefighters']","['aspirin and placebo supplementation, and chronic (81\u200amg; 14 days) aspirin and placebo supplementation', 'Aspirin', 'placebo', 'aspirin supplementation']","['inflammatory biomarkers', 'IL-6, MMP-9, and P-Selectin', 'TAC and ICAM-1', 'Inflammatory proteins [interleukin (IL)-6, C-reactive protein (CRP), intracellular adhesion molecule (ICAM)-1, P-selectin, matrix metalloproteinase-9 (MMP-9)] and antioxidant potential [total antioxidant capacity (TAC']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0221459', 'cui_str': 'Fire and Rescue Personnel'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0134835', 'cui_str': 'Platelet alpha-Granule Membrane Protein'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}, {'cui': 'C0165519', 'cui_str': '92-kDa Type IV Collagenase'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",24.0,0.279146,"RESULTS


Firefighting activities significantly increased IL-6, MMP-9, and P-Selectin; however, no changes in TAC and ICAM-1 were detected.","[{'ForeName': 'Denise L', 'Initials': 'DL', 'LastName': 'Smith', 'Affiliation': 'Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, New York (Drs Smith, Friedman, Bloom, Armero), School of Health Studies, University of Memphis, Memphis, Tennessee (Dr Pence), Department of Human Performance & Leisure Studies, North Carolina A&T State University, Greensboro, North Carolina (Dr Cook), Department of Kinesiology & Nutrition, Integrative Physiology Laboratory, University of Illinois at Chicago, Chicago, Illinois (Dr Fernhall), Department of Mechanical Science and Engineering, University of Illinois, Urbana-Champaign, Illinois (Dr Horn), Illinois Fire Service Institute, Urbana-Champaign, Illinois (Drs Horn, Smith), and Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois (Drs Horn, Woods).'}, {'ForeName': 'Nicholas M G', 'Initials': 'NMG', 'LastName': 'Friedman', 'Affiliation': ''}, {'ForeName': 'Samuel I', 'Initials': 'SI', 'LastName': 'Bloom', 'Affiliation': ''}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Armero', 'Affiliation': ''}, {'ForeName': 'Brandt D', 'Initials': 'BD', 'LastName': 'Pence', 'Affiliation': ''}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Cook', 'Affiliation': ''}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Fernhall', 'Affiliation': ''}, {'ForeName': 'Gavin P', 'Initials': 'GP', 'LastName': 'Horn', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Woods', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001626']
1280,31800931,[Text messaging to improve patient adherence in haart: randomized controlled trial].,"OBJECTIVES.


To assess the efficacy of a text messaging (SMS) strategy to improve appointment attendance, treatment adherence, and biological markers (viral load and CD4) in continuous patients with high activity antiretroviral therapy (HAART) who were late to their last scheduled appointment.
MATERIALS AND METHODS.


A randomized controlled trial implemented in Via Libre, a non-governmental organization (NGO) that provides services to people living with human immunodeficiency virus (HIV) in Lima, Peru, was conducted, where 166 follow-up patients were randomized: 82 participants received SMS for six months and 84 participants received standard care.
RESULTS.


Patients in the intervention group: 93.9% were men and had a median of 5.1 years in HAART; in the control group: 94.1% were men and a median of 5.3 years in HAART. In the intervention group, patients attended their scheduled medical appointments more frequently than those in the control group (RR=1.89, 95% CI 1.21-2.97) during the six months of intervention. Comparing the viral load level and CD4 level, no differences were found (p=0.930 and p=0.905, respectively). Adherence to treatment measured by self-report was higher in the intervention group (p<0.001).
CONCLUSIONS.


The results of this study suggest that sending SMS for six months may improve appointment attendance and adherence to treatment in continuing patients on HAART.",2019,"Comparing the viral load level and CD4 level, no differences were found (p=0.930 and p=0.905, respectively).","['continuous patients with high activity antiretroviral therapy (HAART) who were late to their last scheduled appointment', 'Patients in the intervention group: 93.9% were men and had a median of 5.1 years in HAART; in the control group: 94.1% were men and a median of 5.3 years in HAART', 'people living with human immunodeficiency virus (HIV) in Lima, Peru, was conducted, where 166 follow-up patients were randomized: 82 participants received']","['sending SMS', 'text messaging (SMS) strategy', 'SMS']","['appointment attendance, treatment adherence, and biological markers (viral load and CD4', 'appointment attendance and adherence', 'viral load level and CD4 level']","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0887947', 'cui_str': 'HAART'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",82.0,0.113788,"Comparing the viral load level and CD4 level, no differences were found (p=0.930 and p=0.905, respectively).","[{'ForeName': 'Iván Renato André Condori', 'Initials': 'IRAC', 'LastName': 'Lizárraga', 'Affiliation': 'Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia. Lima, Perú.'}, {'ForeName': 'Luis Alberto Menacho', 'Initials': 'LAM', 'LastName': 'Alvirio', 'Affiliation': 'Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia. Lima, Perú.'}, {'ForeName': 'José Enrique', 'Initials': 'JE', 'LastName': 'Pérez-Lu', 'Affiliation': 'Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia. Lima, Perú.'}, {'ForeName': 'César Cárcamo', 'Initials': 'CC', 'LastName': 'Cavagnaro', 'Affiliation': 'Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia. Lima, Perú.'}]",Revista peruana de medicina experimental y salud publica,['10.17843/rpmesp.2019.363.4139']
1281,31246557,"Twice-a-day training improves mitochondrial efficiency, but not mitochondrial biogenesis, compared with once-daily training.","Exercise training performed with lowered muscle glycogen stores can amplify adaptations related to oxidative metabolism, but it is not known if this is affected by the ""train-low"" strategy used (i.e., once-daily versus twice-a-day training). Fifteen healthy men performed 3 wk of an endurance exercise (100-min) followed by a high-intensity interval exercise 2 (twice-a-day group,  n  = 8) or 14 h (once-daily group,  n  = 7) later; therefore, the second training session always started with low muscle glycogen in both groups. Mitochondrial efficiency (state 4 respiration) was improved only for the twice-a-day group (group × training interaction,  P  < 0.05). However, muscle citrate synthase activity, mitochondria, and lipid area in intermyofibrillar and subsarcolemmal regions, and PGC1α, PPARα, and electron transport chain relative protein abundance were not altered with training in either group ( P  > 0.05). Markers of aerobic fitness (e.g., peak oxygen uptake) were increased, and plasma lactate, O 2  cost, and rating of perceived exertion during a 100-min exercise task were reduced in both groups, although the reduction in rating of perceived exertion was larger in the twice-a-day group (group × time × training interaction,  P  < 0.05). These findings suggest similar training adaptations with both training low approaches; however, improvements in mitochondrial efficiency and perceived effort seem to be more pronounced with twice-a-day training. NEW & NOTEWORTHY  We assessed, for the first time, the differences between two ""train-low"" strategies (once-daily and twice-a-day) in terms of training-induced molecular, functional, and morphological adaptations. We found that both strategies had similar molecular and morphological adaptations; however, only the twice-a-day strategy increased mitochondrial efficiency and had a superior reduction in the rating of perceived exertion during a constant-load exercise compared with once-daily training. Our findings provide novel insights into skeletal muscle adaptations using the ""train-low"" strategy.",2019,"Mitochondrial efficiency (state 4 respiration) was improved only for the twice-a-day group (group x training interaction, p<0.05).",['Fifteen healthy men'],"['endurance exercise (100-min) followed by a high-intensity interval exercise', 'Exercise training']","['plasma lactate, O 2  cost, and rating of perceived exertion during a 100-min exercise task', 'Mitochondrial efficiency (state 4 respiration', 'mitochondrial efficiency', 'muscle citrate synthase activity, mitochondria and lipid area in intermyofibrillar and subsarcolemmal regions, and PGC1α, PPARα, and electron transport chain relative protein abundance', 'rating of perceived exertion']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0312285', 'cui_str': 'Citrate (re)-synthase (substance)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0026237', 'cui_str': 'Mitochondria'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0013846', 'cui_str': 'Electron Transport'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",15.0,0.0259097,"Mitochondrial efficiency (state 4 respiration) was improved only for the twice-a-day group (group x training interaction, p<0.05).","[{'ForeName': 'Thaysa', 'Initials': 'T', 'LastName': 'Ghiarone', 'Affiliation': 'Sport Science Research Group, Department of Physical Education and Sports Science, Academic Center of Vitoria, Federal University of Pernambuco, Vitoria de Santo Antao, Pernambuco, Brazil.'}, {'ForeName': 'Victor A', 'Initials': 'VA', 'LastName': 'Andrade-Souza', 'Affiliation': 'Sport Science Research Group, Department of Physical Education and Sports Science, Academic Center of Vitoria, Federal University of Pernambuco, Vitoria de Santo Antao, Pernambuco, Brazil.'}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Learsi', 'Affiliation': 'Sciences Applied in Sports Research Group, Institute of Biological and Health Sciences, Federal University of Alagoas, Maceio, Alagoas, Brazil.'}, {'ForeName': 'Fabiano', 'Initials': 'F', 'LastName': 'Tomazini', 'Affiliation': 'Human Performance Research Group, Academic Department of Physical Education, Technological Federal University of Parana and Federal University of Parana, Curitiba, Parana, Brazil.'}, {'ForeName': 'Thays', 'Initials': 'T', 'LastName': 'Ataide-Silva', 'Affiliation': 'Faculty of Nutrition, Federal University of Alagoas, Maceio, Alagoas, Brazil.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Sansonio', 'Affiliation': 'Sport Science Research Group, Department of Physical Education and Sports Science, Academic Center of Vitoria, Federal University of Pernambuco, Vitoria de Santo Antao, Pernambuco, Brazil.'}, {'ForeName': 'Mariana P', 'Initials': 'MP', 'LastName': 'Fernandes', 'Affiliation': 'Sport Science Research Group, Department of Physical Education and Sports Science, Academic Center of Vitoria, Federal University of Pernambuco, Vitoria de Santo Antao, Pernambuco, Brazil.'}, {'ForeName': 'Karina L', 'Initials': 'KL', 'LastName': 'Saraiva', 'Affiliation': 'Nucleus of Technological Platforms, Aggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil.'}, {'ForeName': 'Regina C B Q', 'Initials': 'RCBQ', 'LastName': 'Figueiredo', 'Affiliation': 'Laboratory of Cell Biology, Department of Microbiology, Aggeu Magalhães Institute, FIOCRUZ, Recife, Brazil.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Tourneur', 'Affiliation': 'Sport Science Research Group, Department of Physical Education and Sports Science, Academic Center of Vitoria, Federal University of Pernambuco, Vitoria de Santo Antao, Pernambuco, Brazil.'}, {'ForeName': 'Jujiao', 'Initials': 'J', 'LastName': 'Kuang', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Adriano E', 'Initials': 'AE', 'LastName': 'Lima-Silva', 'Affiliation': 'Sport Science Research Group, Department of Physical Education and Sports Science, Academic Center of Vitoria, Federal University of Pernambuco, Vitoria de Santo Antao, Pernambuco, Brazil.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bishop', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Victoria, Australia.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00060.2019']
1282,31288902,Cost utility analysis of pharmacist counseling care for breast cancer chemotherapy outpatients.,"Chemotherapy for cancer is increasingly implemented in the outpatient setting. Pharmacists contribute to cancer treatment by conducting counseling during outpatient chemotherapy visits. They provide guidance on drug treatment, side effects, and side effect countermeasures on every visit. However, there have been few economic evaluations of pharmacist involvement in outpatient chemotherapy. Therefore, we performed a cost utility analysis. We assigned usual care (control) and pharmacist counseling to two groups of 19 patients receiving outpatient chemotherapy for breast cancer at Gifu Municipal hospital. Quality of life was measured at three timepoints before and during chemotherapy treatment using the EuroQol 5 dimension instrument (EQ-5D). EQ-5D values across the timepoints were 0.831, 0.757, and 0.791 for the control group, and 0.882, 0.883, and 0.921 for the pharmacist counseling group. The additional cost in the pharmacist counseling group was 2,227 yen per counseling session. The change in quality-adjusted life years (QALY) was a maximum of -0.021±0.186 in the control group and 0.007±0.199 in the pharmacist counseling group. The maximum cost for one QALY was 1,360,558 yen (≈12,460 US dollars). Pharmacists' counseling in outpatient cancer chemotherapy for breast cancer patients had an acceptable incremental cost-effect ratio, contributing to improved patient quality of life without significant additional expenditure to healthcare.",2019,The change in quality-adjusted life years (QALY) was a maximum of -0.021±0.186 in the control group and 0.007±0.199 in the pharmacist counseling group.,"['19 patients receiving outpatient chemotherapy for breast cancer at Gifu Municipal hospital', 'breast cancer patients', 'breast cancer chemotherapy outpatients']","['Chemotherapy', 'pharmacist counseling care', 'usual care (control) and pharmacist counseling']","['quality-adjusted life years (QALY', 'EQ-5D values', 'Quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0020013', 'cui_str': 'Hospitals, City, Public-Owned'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0034380'}]",,0.0271923,The change in quality-adjusted life years (QALY) was a maximum of -0.021±0.186 in the control group and 0.007±0.199 in the pharmacist counseling group.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tachi', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hori', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Osawa', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nagaya', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Makino', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yasuda', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mizui', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nakada', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Goto', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Teramachi', 'Affiliation': ''}]",Die Pharmazie,['10.1691/ph.2019.9327']
1283,32409561,"Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial.","OBJECTIVE


To assess the efficacy and safety of hydroxychloroquine plus standard of care compared with standard of care alone in adults with coronavirus disease 2019 (covid-19).
DESIGN


Multicentre, open label, randomised controlled trial.
SETTING


16 government designated covid-19 treatment centres in China, 11 to 29 February 2020.
PARTICIPANTS


150 patients admitted to hospital with laboratory confirmed covid-19 were included in the intention to treat analysis (75 patients assigned to hydroxychloroquine plus standard of care, 75 to standard of care alone).
INTERVENTIONS


Hydroxychloroquine administrated at a loading dose of 1200 mg daily for three days followed by a maintenance dose of 800 mg daily (total treatment duration: two or three weeks for patients with mild to moderate or severe disease, respectively).
MAIN OUTCOME MEASURE


Negative conversion of severe acute respiratory syndrome coronavirus 2 by 28 days, analysed according to the intention to treat principle. Adverse events were analysed in the safety population in which hydroxychloroquine recipients were participants who received at least one dose of hydroxychloroquine and hydroxychloroquine non-recipients were those managed with standard of care alone.
RESULTS


Of 150 patients, 148 had mild to moderate disease and two had severe disease. The mean duration from symptom onset to randomisation was 16.6 (SD 10.5; range 3-41) days. A total of 109 (73%) patients (56 standard of care; 53 standard of care plus hydroxychloroquine) had negative conversion well before 28 days, and the remaining 41 (27%) patients (19 standard of care; 22 standard of care plus hydroxychloroquine) were censored as they did not reach negative conversion of virus. The probability of negative conversion by 28 days in the standard of care plus hydroxychloroquine group was 85.4% (95% confidence interval 73.8% to 93.8%), similar to that in the standard of care group (81.3%, 71.2% to 89.6%). The difference between groups was 4.1% (95% confidence interval -10.3% to 18.5%). In the safety population, adverse events were recorded in 7/80 (9%) hydroxychloroquine non-recipients and in 21/70 (30%) hydroxychloroquine recipients. The most common adverse event in the hydroxychloroquine recipients was diarrhoea, reported in 7/70 (10%) patients. Two hydroxychloroquine recipients reported serious adverse events.
CONCLUSIONS


Administration of hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard of care alone in patients admitted to hospital with mainly persistent mild to moderate covid-19. Adverse events were higher in hydroxychloroquine recipients than in non-recipients.
TRIAL REGISTRATION


ChiCTR2000029868.",2020,"CONCLUSIONS


Administration of hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard of care alone in patients admitted to hospital with mainly persistent mild to moderate covid-19.","['adults with coronavirus disease 2019 (covid-19', 'patients with mainly mild to moderate coronavirus disease 2019', 'Of 150 patients, 148 had mild to moderate disease and two had severe disease', 'A total of 109 (73%) patients (56 standard of care; 53 standard of care plus', '16 government designated covid-19 treatment centres in China, 11 to 29 February 2020', '150 patients admitted to hospital with laboratory confirmed covid-19 were included in the intention to treat analysis (75 patients assigned to', 'patients admitted to hospital with mainly persistent mild to moderate covid-19']","['care plus hydroxychloroquine', 'hydroxychloroquine', 'Hydroxychloroquine', 'hydroxychloroquine plus standard of care, 75 to standard of care alone', 'hydroxychloroquine plus standard of care compared with standard of care alone', 'hydroxychloroquine and hydroxychloroquine']","['probability of negative conversion', 'Adverse events', 'diarrhoea', 'efficacy and safety', 'serious adverse events', 'mean duration from symptom onset to randomisation', 'adverse events', 'negative conversion']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",150.0,0.283224,"CONCLUSIONS


Administration of hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard of care alone in patients admitted to hospital with mainly persistent mild to moderate covid-19.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhujun', 'Initials': 'Z', 'LastName': 'Cao', 'Affiliation': 'Department of Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.'}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ""Department of Respiratory Medicine, No 2 People's Hospital of Fuyang City, Fuyang, Anhui, China.""}, {'ForeName': 'Zhengyan', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Suizhou Hospital, Hubei University of Medicine, Suizhou, Hubei, China.'}, {'ForeName': 'Junwen', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Xiangyang No 1 People's Hospital, Hubei University of Medicine, Xiangyang, Hubei, China.""}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Infectious Diseases, Central Hospital of Ezhou, Ezhou, Hubei, China.'}, {'ForeName': 'Yaojie', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiovascular Medicine, Yunmeng People's Hospital, Xiaogan, Hubei, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Department of Respiratory Medicine, First People's Hospital of Jingzhou City, Jingzhou, Hubei, China.""}, {'ForeName': 'Shengyong', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Infectious Diseases, Xiaogan Hospital Affiliated to Wuhan University of Science and Technology, Xiaogan, Hubei, China.'}, {'ForeName': 'Erzhen', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiongbiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jiuyong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Respiratory Medicine, Hubei Space Hospital of Xiaogan, Xiaogan, Hubei, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Qingxia', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': ""Department of Infectious Disease, The Sixth People's Hospital of Zhengzhou, Zhengzhou, Henan, China.""}, {'ForeName': 'Youqin', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Infectious Disease, Wuhan No 7 Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Zhibin', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Departments of Respiratory Medicine, Xiaogan Hospital Affiliated to Wuhan University of Science and Technology, Xiaogan, Hubei, China xieqingrjh@163.com.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Respiratory Medicine, The Third People's Hospital of Yichang, Yichang, Hubei, China.""}, {'ForeName': 'Yaofeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Respiratory Medicine, Xiao Gan First People's Hospital, Xiaogan, Hubei Province, China.""}, {'ForeName': 'Leshan', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Clinical Research Centre, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jieming', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Ning', 'Affiliation': 'Shanghai National Research Centre for Endocrine and Metabolic Diseases, State Key Laboratory of Medical Genomics, Shanghai Institute for Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guochao', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China xieqingrjh@163.com.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m1849']
1284,31186189,The relative effects of determinants on Chinese adults' decision for influenza vaccination choice: What is the effect of priming?,"OBJECTIVES


To assess the relative effects of altering different factors (attributes) related to adults' decision for influenza vaccination choice, and whether priming modifies these relative effects.
METHODS


Chinese adults were randomly allocated to either a control condition (non-risk related video), or one of the three health risk-priming conditions (disease (influenza) risk video, intervention (vaccine) risk video, or non-specific (air pollution) risk video), each comprising ∼200 participants, prior to a discrete choice experiment survey. Mixed logit modelling estimated the relative effects of pre-determined attributes influencing vaccination choice.
RESULTS


Across all four conditions, for determining vaccination choice, Vaccine Efficacy had a greater effect than social cues (community vaccination coverage rate (CVCR) and doctors' advice) but social cues can compensate for the effect of ""uncertain"" vaccine safety; influenza case-fatality ratio (CFR) became dominantly important among all included attributes when it reached 20%; vaccination preference increased when a CVCR changed incrementally from 5% to 60% but declined thereafter when the CVCR reached 80%. Compared with Control participants, a CVCR increased by 80% had a smaller effect for participants primed by intervention risk on vaccination choice, while the effect of influenza risk relative to vaccine risk increased following disease risk priming.
CONCLUSION


While increasing confidence on vaccine efficacy is more important for influenza with less severe consequences, highlighting disease consequences becomes increasingly important when its CFR increases, for promoting vaccination uptake. For a new vaccine with uncertain safety, involving doctors and early vaccine takers to validate vaccine safety should be important. Brief exposure to influenza/vaccine risk didn't increase the effect of specific risk on vaccination choice but may change the relative weight of disease versus intervention risk when individuals make trade-off for vaccination decision. Free riding on herd immunity may increase when community vaccination coverage is high particularly following intervention risk priming.",2019,"Across all four conditions, for determining vaccination choice, Vaccine Efficacy had a greater effect than social cues (community vaccination coverage rate (CVCR) and doctors' advice) but social cues can compensate for the effect of ""uncertain"" vaccine safety; influenza case-fatality ratio (CFR) became dominantly important among all included attributes when it reached 20%; vaccination preference increased when a CVCR changed incrementally from 5% to 60% but declined thereafter when the CVCR reached 80%.",['Chinese adults'],"['control condition (non-risk related video), or one of the three health risk-priming conditions (disease (influenza) risk video, intervention (vaccine) risk video, or non-specific (air pollution) risk video']","[""social cues (community vaccination coverage rate (CVCR) and doctors' advice"", 'vaccination preference', 'CVCR']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0001873', 'cui_str': 'Air Pollution'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4505148', 'cui_str': 'Vaccination Coverage'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",,0.0663111,"Across all four conditions, for determining vaccination choice, Vaccine Efficacy had a greater effect than social cues (community vaccination coverage rate (CVCR) and doctors' advice) but social cues can compensate for the effect of ""uncertain"" vaccine safety; influenza case-fatality ratio (CFR) became dominantly important among all included attributes when it reached 20%; vaccination preference increased when a CVCR changed incrementally from 5% to 60% but declined thereafter when the CVCR reached 80%.","[{'ForeName': 'Qiuyan', 'Initials': 'Q', 'LastName': 'Liao', 'Affiliation': 'Division of Behavioural Sciences, School of Public Health, The University of Hong Kong, Hong Kong, China. Electronic address: qyliao11@hku.hk.'}, {'ForeName': 'Wendy Wing Tak', 'Initials': 'WWT', 'LastName': 'Lam', 'Affiliation': 'Division of Behavioural Sciences, School of Public Health, The University of Hong Kong, Hong Kong, China. Electronic address: wwtlam@hku.hk.'}, {'ForeName': 'Carlos King Ho', 'Initials': 'CKH', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, The University of Hong Kong, Hong Kong, China. Electronic address: carlosho@hku.hk.'}, {'ForeName': 'Cherry', 'Initials': 'C', 'LastName': 'Lam', 'Affiliation': 'Division of Behavioural Sciences, School of Public Health, The University of Hong Kong, Hong Kong, China. Electronic address: cylam1@hku.hk.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China. Electronic address: pianogal@hku.hk.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fielding', 'Affiliation': 'Division of Behavioural Sciences, School of Public Health, The University of Hong Kong, Hong Kong, China. Electronic address: fielding@hku.hk.'}]",Vaccine,['10.1016/j.vaccine.2019.05.072']
1285,31261260,Perineal Pressure During Hip Arthroscopy Is Reduced by Use of Trendelenburg: A Prospective Study With Randomized Order of Positioning.,"BACKGROUND


The use of traction during hip arthroscopy is commonly used to provide safe joint access and to improve visualization. However, traction during hip arthroscopy has been associated with complications ranging from transient neuropraxias to devastating soft-tissue necrosis. Trendelenburg positioning may be helpful, but the degree to which this is true is not well understood.
QUESTIONS/PURPOSES


To determine whether there would be a reduction in perineal pressure at 5°, 10°, and 15° of Trendelenburg compared with baseline (0° of Trendelenburg) while in the modified supine position during hip arthroscopy.
METHODS


A consecutive cohort of 50 patients treated with hip arthroscopy by a single, high-volume orthopaedic surgeon was analyzed. There were 30 females and 20 males in this study, with a mean age of 36 ± 16 years (range, 14 to 66 years); mean BMI was 26 kg/m. In the operating room, patients were placed in the modified supine position on a traction extension table with a well-padded perineal post. A standard blood pressure cuff was secured to the post to measure pressure exerted on the perineum as traction was applied to distract the hip. For each patient, pressure against the perineum was measured at four different positions using a digital level: 0°, 5°, 10°, and 15° of Trendelenburg. These positions were tested in a random order for each patient. Mean pressure was compared within patients under the four-period crossover design using a repeated-measure (mixed) ANOVA model. Examination of the residual error quantile plot showed that the pressure data followed a normal distribution, making the use of a parametric model appropriate. Tests were made for period and order effects.
RESULTS


Compared with baseline (0° or no Trendelenburg) there was a reduction in pressure of 4.4 (15.5%) at 5° of Trendelenburg (p = 0.203), 8 (28%) at 10° of Trendelenburg (p = 0.022) and 13.1 (46%) at 15° (p = 0.006). These results were maintained regardless of the sequence of positions used in each patient (0°, 5°, 10°, 15°).
CONCLUSIONS


Trendelenburg positioning of 10° and 15° during hip arthroscopy resulted in decreased perineal pressure compared with the neutral (0°) position. This technique is intended to harness gravity to exert the majority of countertraction while retaining the perineal post as a backup patient stabilizer. Routine introduction of Trendelenburg during hip arthroscopy reduces perineal pressure against the post, which may decrease complications related to traction and perineal pressure. Future studies should assess whether the observed differences in perineal pressure will reduce the frequency of post-related complications after hip arthroscopy.
LEVEL OF EVIDENCE


Level II, therapeutic study.",2019,"Routine introduction of Trendelenburg during hip arthroscopy reduces perineal pressure against the post, which may decrease complications related to traction and perineal pressure.","['A consecutive cohort of 50 patients treated with hip arthroscopy by a single, high-volume orthopaedic surgeon was analyzed', '30 females and 20 males in this study, with a mean age of 36 ± 16 years (range, 14 to 66 years); mean BMI was 26 kg/m']","['Hip Arthroscopy', 'Trendelenburg']","['Mean pressure', 'Perineal Pressure', 'perineal pressure', 'reduction in pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0334891', 'cui_str': 'Orthopedists'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}]","[{'cui': 'C0445074', 'cui_str': 'Mean pressure (qualifier value)'}, {'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0289102,"Routine introduction of Trendelenburg during hip arthroscopy reduces perineal pressure against the post, which may decrease complications related to traction and perineal pressure.","[{'ForeName': 'Ajay C', 'Initials': 'AC', 'LastName': 'Lall', 'Affiliation': 'A. C. Lall, M. R. Battaglia, D. R. Maldonado, B. G. Domb, American Hip Institute, Des Plaines, IL, USA A. A. Saadat, Department of Orthopedics, University of Illinois at Chicago, Chicago, IL, USA M. R. Battaglia, University of Chicago Pritzker School of Medicine, Chicago, IL, USA I. Perets, Department of Orthopedics, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Ardavan A', 'Initials': 'AA', 'LastName': 'Saadat', 'Affiliation': ''}, {'ForeName': 'Muriel R', 'Initials': 'MR', 'LastName': 'Battaglia', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Maldonado', 'Affiliation': ''}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Perets', 'Affiliation': ''}, {'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Domb', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000804']
1286,26898720,Adherence to recommendations on lipid-based nutrient supplement and iron and folic acid tablet consumption among pregnant and lactating women participating in a community health programme in northwest Bangladesh.,"Limited knowledge exists on sustained adherence to small-quantity lipid-based nutrient supplements for pregnant and lactating women (LNS-PL) and how this compares with that of other prenatal supplements. To address these gaps, a random subsample of women (n = 360) during pregnancy, early (6- to 12-week post-partum) and late (12- to 24-week post-partum) lactation, from an ongoing effectiveness trial in Bangladesh, was selected for in-home interviews about LNS-PL or iron/folic acid (IFA) use and preferences. Prevalence of high adherence (≥70% of the recommendation) based on self-reported supplement consumption was 67%, 68% and 81% among LNS-PL recipients during pregnancy, early and late lactation, and was 87% and 71% among IFA recipients during pregnancy and early lactation, respectively (P = 0.044). Programmatic factors (e.g. distribution and visits by programme staff) were consistently statistically significantly associated with reported high adherence. Among LNS-PL recipients, high overall supplement acceptability score [odds ratio (OR): 8.62; 95% confidence interval (CI) 3.53, 20.83] and use of reminder techniques (OR: 4.41; 95%CI 1.65, 11.76) were positively associated, and reported vomiting at enrollment was negatively associated (OR: 0.34; 95%CI 0.14, 0.80), with reported high adherence. Selected women (n = 16) and key informants (n = 18) participated in in-depth interviews about perceptions and acceptability of LNS-PL. Women perceived benefits of taking LNS-PL, but some faced barriers to consumption including aversion to odour and taste during pregnancy, forgetfulness and disruptions in supply. To achieve high adherence, results from this study suggest that maternal supplementation programmes should focus on programmatic barriers and consider incorporating reminder techniques. Organoleptic acceptability of LNS-PL, particularly during pregnancy, may also need to be addressed.",2017,"Among LNS-PL recipients, high overall supplement acceptability score [odds ratio (OR): 8.62; 95% confidence interval (CI) 3.53, 20.83] and use of reminder techniques (","['random subsample of women (n\u2009=\u2009360) during pregnancy, early (6- to 12-week post-partum) and late (12- to 24-week post-partum) lactation, from an ongoing effectiveness trial in Bangladesh, was selected for in-home interviews about', 'pregnant and lactating women (LNS-PL', 'pregnant and lactating women participating in a community health programme in northwest Bangladesh', 'Selected women (n\u2009=\u200916) and key informants (n\u2009=\u200918) participated in in-depth interviews about perceptions and acceptability of LNS-PL']","['LNS-PL or iron/folic acid (IFA', 'LNS-PL', 'lipid-based nutrient supplement and iron and folic acid tablet consumption']","['Prevalence of high adherence', 'vomiting', 'overall supplement acceptability score', 'Programmatic factors', 'supplement consumption']","[{'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0022925', 'cui_str': 'Milk Secretion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0999001,"Among LNS-PL recipients, high overall supplement acceptability score [odds ratio (OR): 8.62; 95% confidence interval (CI) 3.53, 20.83] and use of reminder techniques (","[{'ForeName': 'Kassandra L', 'Initials': 'KL', 'LastName': 'Harding', 'Affiliation': 'Program in International and Community Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Susana L', 'Initials': 'SL', 'LastName': 'Matias', 'Affiliation': 'Program in International and Community Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Malay K', 'Initials': 'MK', 'LastName': 'Mridha', 'Affiliation': 'Program in International and Community Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Md', 'Initials': 'M', 'LastName': 'Moniruzzaman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Vosti', 'Affiliation': 'Program in International and Community Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Save the Children, Dhaka, Bangladesh.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Program in International and Community Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Program in International and Community Nutrition, University of California, Davis, California, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12252']
1287,31800354,An Open-Label Pilot Study Testing the Feasibility of Assessing Total Symptom Burden in Trials of Cannabinoid Medications in Palliative Care.,"Background:  There is considerable interest in the use of cannabinoids for symptom control in palliative care, but there is little high-quality evidence to guide clinical practice.  Objectives:  Assess the feasibility of using global symptom burden measures to assess response to medicinal cannabis, to determine median tolerated doses of cannabidiol (CBD) and tetrahydrocannabinol (THC), and to document adverse events (AEs).  Design:  Prospective two-arm open-label pilot trial of escalating doses of CBD and THC oil.  Setting/Subjects:  Participants had advanced cancer and cancer-related symptoms in a palliative and supportive care service in an Australian cancer center.  Measurements:  The main outcome measures were the number of participants screened and randomized over the time frame, the number of participants completing days 14 and 28 and providing total symptom distress scores (TSDSs) (measured using the Edmonton Symptom Assessment Scale), and the change from baseline of the TSDS at day 14.  Results:  Of the 21 participants enrolled (CBD,  n  = 16; THC,  n  = 5), 18 (86%) completed the primary outcome measure at day 14 and 8 completed at day 28. The median maximum tolerated doses were CBD, 300 mg/day (range 100-600 mg); THC, 10 mg/day (range 5-30 mg). Nine of 21 patients (43%) met the definition of response (≥6 point reduction in TSDS). Drowsiness was the most common AE.  Conclusions:  Trials of medicinal cannabis in advanced cancer patients undergoing palliative care are feasible. The doses of THC and CBD used in this study were generally well tolerated and the outcome measure of total symptom distress is promising as a measure of overall symptom benefit. Trial registration: ACTRN12618001205224.",2020,The doses of THC and CBD used in this study were generally well tolerated and the outcome measure of total symptom distress is promising as a measure of overall symptom benefit.,"['had advanced cancer and cancer-related symptoms in a palliative and supportive care service in an Australian cancer center', 'advanced cancer patients undergoing palliative care are feasible', 'Trials of Cannabinoid Medications in Palliative Care', '21 participants enrolled (CBD,  n \u2009=\u200916']","['cannabidiol (CBD) and tetrahydrocannabinol (THC', 'medicinal cannabis', 'CBD and THC oil']","['Drowsiness', 'time frame, the number of participants completing days 14 and 28 and providing total symptom distress scores (TSDSs) (measured using the Edmonton Symptom Assessment Scale', 'total symptom distress']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0202349', 'cui_str': 'Cannabinoids measurement (procedure)'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0813973', 'cui_str': 'Medicinal Cannabis'}, {'cui': 'C0028908', 'cui_str': 'Oils'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0222045'}]",,0.248183,The doses of THC and CBD used in this study were generally well tolerated and the outcome measure of total symptom distress is promising as a measure of overall symptom benefit.,"[{'ForeName': 'Phillip D', 'Initials': 'PD', 'LastName': 'Good', 'Affiliation': 'Department of Palliative and Supportive Care, Mater Misericordiae, Ltd., Brisbane, Queensland, Australia.'}, {'ForeName': 'Ristan M', 'Initials': 'RM', 'LastName': 'Greer', 'Affiliation': 'Mater Research University of Queensland, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Georgina E', 'Initials': 'GE', 'LastName': 'Huggett', 'Affiliation': 'Department of Palliative and Supportive Care, Mater Misericordiae, Ltd., Brisbane, Queensland, Australia.'}, {'ForeName': 'Janet R', 'Initials': 'JR', 'LastName': 'Hardy', 'Affiliation': 'Department of Palliative and Supportive Care, Mater Misericordiae, Ltd., Brisbane, Queensland, Australia.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0540']
1288,31798918,"First use of cenerimod, a selective S1P 1  receptor modulator, for the treatment of SLE: a double-blind, randomised, placebo-controlled, proof-of-concept study.","Objective


To investigate the pharmacodynamics, pharmacokinetics and safety of cenerimod-a potent, oral, selective sphingosine 1-phosphate 1 receptor modulator-in patients with SLE.
Methods


This multicentre, double-blind, placebo-controlled study was conducted in two parts. In part A, patients with SLE were randomised 1:1:1:1 to receive oral cenerimod 0.5, 1 or 2 mg, or placebo once daily for 12 weeks. Following an interim safety review of part A, additional patients were randomised 3:1 for part B and received cenerimod 4 mg or placebo once daily for 12 weeks. Endpoints included changes in total lymphocyte count, SLE Disease Activity Index-2000 (SLEDAI-2K) score (modified (mSLEDAI-2K) to exclude leucopenia), biomarker anti-double-stranded DNA (anti-dsDNA) antibodies, pharmacokinetic assessments and treatment-emergent adverse events (TEAEs).
Results


Part A included 49 patients (1:1:1:1 receiving cenerimod 0.5, 1 or 2 mg, or placebo) and part B included 18 patients (13 cenerimod; 5 placebo). Cenerimod caused a statistically significant dose-dependent reduction in total lymphocyte count from baseline to end of treatment (EOT). Compared with placebo at EOT, cenerimod 4 mg had an estimated treatment effect on change from baseline in mSLEDAI-2K score of -2.420 (p=0.0306), and on anti-dsDNA antibodies of -64.55 U/mL (p=0.0082), suggesting clinical and biological improvement in these exploratory efficacy analyses. Trough plasma concentrations were dose proportional and reached steady-state conditions after 4 weeks of once daily dosing. All groups reported similar, non-dose-related frequencies of TEAEs (cenerimod 0.5 mg: 41.7%; 1 mg: 41.7%; 2 mg: 46.2%; 4 mg: 38.5% and placebo: 58.8%). A small, dose-related, non-clinically relevant decrease in heart rate was only observed in the first 6 hours after initiation.
Conclusions


With an acceptable safety profile, the efficacy findings suggest that cenerimod has the potential to treat patients with SLE. Further investigation in larger patient populations with longer treatment duration is warranted.",2019,Cenerimod caused a statistically significant dose-dependent reduction in total lymphocyte count from baseline to end of treatment (EOT).,"['patients with SLE', '49 patients (1:1:1:1 receiving']","['placebo', 'cenerimod 4\u2009mg or placebo', 'cenerimod 0.5, 1 or 2\u2009mg, or placebo', 'oral cenerimod 0.5, 1 or 2\u2009mg, or placebo']","['total lymphocyte count', 'total lymphocyte count, SLE Disease Activity Index-2000 (SLEDAI-2K) score (modified (mSLEDAI-2K) to exclude leucopenia), biomarker anti-double-stranded DNA (anti-dsDNA) antibodies, pharmacokinetic assessments and treatment-emergent adverse events (TEAEs', 'heart rate', 'Trough plasma concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0311474', 'cui_str': 'DNA, Double-Stranded'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",49.0,0.482983,Cenerimod caused a statistically significant dose-dependent reduction in total lymphocyte count from baseline to end of treatment (EOT).,"[{'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Hermann', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Anastas', 'Initials': 'A', 'LastName': 'Batalov', 'Affiliation': 'Rheumatology Department, Medical University of Plovdiv, Plovdiv, Bulgaria.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Smakotina', 'Affiliation': 'Kemerovo Regional Clinical Hospital, Kemerovo, Russia.'}, {'ForeName': 'Pierre-Eric', 'Initials': 'PE', 'LastName': 'Juif', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cornelisse', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",Lupus science & medicine,['10.1136/lupus-2019-000354']
1289,31243790,"First-in-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of an Oral Formulation of DS-1040, an Inhibitor of the Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor, in Healthy Subjects.","DS-1040, a low-molecular-weight imidazole derivative, inhibits the enzymatic activity of thrombin-activatable fibrinolysis inhibitor (TAFIa), enhancing endogenous tissue plasminogen activator-triggered fibrinolysis. This first-in-human, randomized, placebo-controlled, phase 1 study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of an oral formulation of DS-1040. Healthy adults (aged 20-45 years; N = 56) were randomized 3:1 to receive DS-1040 orally administered as single ascending doses (50, 100, 200, or 400 mg) or placebo, or DS-1040 multiple ascending doses (100 mg once daily, 200 mg once daily, or 150 mg twice daily) or placebo for 14 days. Safety, PK, and PD parameters were assessed. All doses of DS-1040 were well tolerated; no serious/severe adverse events (AEs) or discontinuations due to AEs occurred. DS-1040 had no effect on coagulation parameters, and no treatment-related trends in the bleeding time were observed. DS-1040 exposure (peak concentration and area under the concentration-time curve) increased in a dose-proportional manner across the single-dose range. With multiple doses, steady state was achieved by day 7 with minimal accumulation (mean accumulation ratio 1.15-1.25), and the PK was time-independent. After 72 hours, approximately 10% of the DS-1040 400-mg single dose was recovered in urine as intact parent drug. The mean terminal half-life ranged from 17.2 to 24.9 hours, which was similar to previous intravenous administration data. Dose-dependent inhibition of total TAFIa activity was observed following single and multiple doses of oral DS-1040. The safety and PK/PD profiles of oral DS-1040 in healthy subjects support further clinical development.",2019,All doses of DS-1040 were well tolerated; no serious/severe adverse events (AEs) or discontinuations due to AEs occurred.,"['Healthy Subjects', 'Healthy adults (aged 20-45 years; N = 56', 'healthy subjects']","['placebo, or DS-1040 multiple ascending doses', 'placebo', 'DS-1040']","['coagulation parameters', 'Safety, PK, and PD parameters', 'Safety, Pharmacokinetics, and Pharmacodynamics', 'total TAFIa activity', 'tolerated; no serious/severe adverse events', 'DS-1040 exposure (peak concentration and area under the concentration-time curve', 'safety, pharmacokinetics (PK), and pharmacodynamics (PD', 'bleeding time']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0005729', 'cui_str': 'Bleeding Time'}]",56.0,0.0991134,All doses of DS-1040 were well tolerated; no serious/severe adverse events (AEs) or discontinuations due to AEs occurred.,"[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Tharin', 'Initials': 'T', 'LastName': 'Limsakun', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Ophelia', 'Initials': 'O', 'LastName': 'Yin', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Vance', 'Initials': 'V', 'LastName': 'Warren', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Zamora', 'Affiliation': 'Worldwide Clinical Trials, San Antonio, TX, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Atiee', 'Affiliation': 'Worldwide Clinical Trials, San Antonio, TX, USA.'}, {'ForeName': 'Jarema', 'Initials': 'J', 'LastName': 'Kochan', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pav', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Kobayashi', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Vashi', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Dishy', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1474']
1290,31699735,"CRISTAL: protocol for a cluster randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study.","INTRODUCTION


Venous thromboembolism (VTE) is a serious complication following hip arthroplasty (HA) and knee arthroplasty (KA). This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA.
METHODS AND ANALYSIS


This is a cluster randomised, crossover, non-inferiority, trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will consist of Australian hospitals performing at least 250 HA and/or KA procedures per annum. All adult patients undergoing HA or KA will be included. The intervention will be aspirin, orally, 85-150 mg daily. The comparator will be LMWH (enoxaparin) 40 mg, subcutaneously, daily. Both drugs will commence within 24 hours postoperatively and continue for 35 days after HA and 14 days after KA. Each hospital will be randomised to commence with aspirin or LMWH and then crossover to the alternative treatment after meeting the recruitment target. Data will be collected through the AOANJRR via patient-reported surveys. The primary outcome is symptomatic VTE within 90 days post surgery, verified by AOANJRR staff. The primary analysis will include only patients undergoing elective primary total hip arthroplasty and total knee arthroplasty for osteoarthritis. Secondary outcomes will include symptomatic VTE for all HA and KA (including partial and revision) within 90 days, readmission, reoperation, major bleeding and death within 90 days and reoperation, death and patient-reported pain, function and health status at 6 months. If aspirin is found to be inferior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 15 562 patients from 31 hospitals.
ETHICS AND DISSEMINATION


Ethics approval has been granted. Trial results will be submitted for publication. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001879257, pre-results) and is endorsed by the Australia and New Zealand Musculoskeletal Clinical Trials Network.",2019,"This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA.
","['patients undergoing elective primary total hip arthroplasty and total knee arthroplasty for osteoarthritis', 'hip or knee arthroplasty, a registry nested study', 'recruit 15\u2009562 patients from 31 hospitals', 'All adult patients undergoing HA or KA', 'hip arthroplasty (HA) and knee arthroplasty (KA']","['LMWH (enoxaparin', 'aspirin or LMWH', 'aspirin']","['symptomatic VTE within 90 days post surgery, verified by AOANJRR staff', 'symptomatic VTE for all HA and KA (including partial and revision) within 90 days, readmission, reoperation, major bleeding and death within 90 days and reoperation, death and patient-reported pain, function and health status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",250.0,0.254228,"This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA.
","[{'ForeName': 'Verinder Singh', 'Initials': 'VS', 'LastName': 'Sidhu', 'Affiliation': 'CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia verinder.s.sidhu@gmail.com.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Graves', 'Affiliation': 'Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Buchbinder', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Justine Maree', 'Initials': 'JM', 'LastName': 'Naylor', 'Affiliation': 'CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Pratt', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'de Steiger', 'Affiliation': 'Department of Surgery, Epworth Healthcare, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Beng H', 'Initials': 'BH', 'LastName': 'Chong', 'Affiliation': 'Department of Haematology, Saint George and Sutherland Clinical School, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ilana N', 'Initials': 'IN', 'LastName': 'Ackerman', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Adie', 'Affiliation': 'Faculty of Medicine, Saint George and Sutherland Clinical School, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': 'Monash University Centre for Health Economics, Caufield, Victoria, Australia.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Hansen', 'Affiliation': 'CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Cripps', 'Affiliation': 'CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Lorimer', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Webb', 'Affiliation': 'Department of Intensive Care, St John of God Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Clavisi', 'Affiliation': 'Musculoskeletal Australia, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Griffith', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Durga', 'Initials': 'D', 'LastName': 'Anandan', 'Affiliation': 'Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': ""O'Donohue"", 'Affiliation': 'Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.'}, {'ForeName': 'Thu-Lan', 'Initials': 'TL', 'LastName': 'Kelly', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Harris', 'Affiliation': 'CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-031657']
1291,31239010,A Tailored Behavioral Intervention to Promote Adherence to the DASH Diet.,"Objectives:  In this study, we evaluated the effects of a Transtheoretical model (TTM)-based tailored behavioral intervention (TBI), a non-tailored intervention (NTI) or usual care (UC) on: (1) the Dietary Approaches to Stop Hypertension (DASH) dietary pattern in 533 individuals with uncontrolled hypertension; and (2) the change from baseline to 6 months in proportion of participants in action or maintenance stages of change (SOC).  Methods:  This was a randomized clinical trial. Diet was evaluated using the validated Harvard DASH score calculated from Willett Food Frequency Questionnaires (range 8-40). The randomized groups were compared using the Wilcoxon rank-sum test, with adjustment for clustering by physician and baseline DASH scores.  Results:  At 6 months, compared to UC, TBI had a 1.28 point increase in DASH score (p ≤ .01) while NTI was not significant. At 6-month follow-up, TBI was more effective in advancing dietary SOC when compared to UC (56% vs 43%, p < .01) and NTI was not effective (46% vs 43%, p = .64).  Conclusions:  A phone-delivered tailored TTM-based intervention achieved greater improvement in DASH score and dietary SOC, suggesting that TTM-based tailored interventions can increase patients' dietary adherence.",2019,"At 6 months, compared to UC, TBI had a 1.28 point increase in DASH score (p ≤ .01) while NTI was not significant.",['533 individuals with uncontrolled hypertension'],"['Behavioral Intervention', 'Transtheoretical model (TTM)-based tailored behavioral intervention (TBI), a non-tailored intervention (NTI) or usual care (UC) on: (1) the Dietary Approaches to Stop Hypertension (DASH) dietary pattern']","['DASH score and dietary SOC', 'DASH score']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",533.0,0.0230165,"At 6 months, compared to UC, TBI had a 1.28 point increase in DASH score (p ≤ .01) while NTI was not significant.","[{'ForeName': 'Maria Antonia', 'Initials': 'MA', 'LastName': 'Rodriguez', 'Affiliation': 'Health Science Specialist, VA New York Harbor Healthcare System, New York, NY.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Friedberg', 'Affiliation': 'Women Veteran Program Manager, VA New York Harbor Healthcare System, New York, NY.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'DiGiovanni', 'Affiliation': 'Health Science Specialist, VA New York Harbor Healthcare System, New York, NY.'}, {'ForeName': 'Binhuan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Assistant Professor, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Wylie-Rosett', 'Affiliation': 'Division Head, Division of Health Promotion and Nutrition Research, Department of Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Sangmin', 'Initials': 'S', 'LastName': 'Hyoung', 'Affiliation': 'Health Science Specialist, VA New York Harbor Healthcare System, New York, NY.'}, {'ForeName': 'Sundar', 'Initials': 'S', 'LastName': 'Natarajan', 'Affiliation': 'Staff Physician, VA New York Harbor Healthcare System, New York, NY;, Email: sundar.natarajan@va.gov.'}]",American journal of health behavior,['10.5993/AJHB.43.4.1']
1292,31783762,A home visit program versus a non-home visit program in total knee replacement patients: a randomized controlled trial.,"BACKGROUND


The goals in total knee replacement (TKR) are pain relief, restore functions, and improve quality of life. Surgical outcomes were not related to patients' satisfaction. Low 1-year WOMAC especially in the first 6 weeks and painful TKR related to patient dissatisfied. To improve satisfaction, we created the home visit program (TKR-H) after hospital discharge. INHOMESSS was the rationale for home visit activities.
METHODS


We recruited 52 TKRs. Four TKRs were excluded. We used simple randomization for 24 patients as a home visit (TKR-H) and 24 patients as a non-home visit (TKR). Patients were evaluated by general demographics, pain intensity scores (VAS), range of motion (ROM), WOMAC, knee scores, and functional scores as a primary objective. A duration for gait aid independent and patient's satisfaction score as secondary objective. The study was 6 weeks after surgery.
RESULTS


TKR-H and TKR had significant differences in the mean of WOMAC score (88.29 ± 10.66 vs. 68.00 ± 12.47, respectively, P <  0.001), pain score (VAS) (6.25 ± 10.13 vs. 35.67 ± 22.05, respectively, P <  0.001), knee score (81.67 ± 10.08 vs. 68.38 ± 6.45, respectively, P <  0.001), functional score (77.83 ± 4.22 vs. 73.70 ± 7.48, respectively, P = 0.037), and range of motion (107.71 ± 8.47 vs. 98.17 ± 9.57, respectively, P = 0.001). The patient's satisfaction score in TKR-H group (4.71 ± 0.46) was significantly higher than the TKR group (4.13 ± 0.45) (P <  0.001) and time to gait aid independent (2.75 ± 0.99 vs. 3.71 ± 1.23, respectively, P = 0.005).
CONCLUSION


Our TKR-H showed better clinical outcomes and satisfaction than non-home visit. The rationale in TKR-H improves satisfaction after total knee replacement.
TRIAL REGISTRATION


TCTR20190514001.",2019,"The patient's satisfaction score in TKR-H group (4.71 ± 0.46) was significantly higher than the TKR group (4.13 ± 0.45) (P <  0.001) and time to gait aid independent (2.75 ± 0.99 vs. 3.71 ± 1.23, respectively, P = 0.005).
","['total knee replacement patients', '24 patients as a home visit (TKR-H) and 24 patients as a non-home visit (TKR']","['total knee replacement (TKR', 'home visit program versus a non-home visit program']","['time to gait aid', 'quality of life', 'pain score (VAS', 'general demographics, pain intensity scores (VAS), range of motion (ROM), WOMAC, knee scores, and functional scores', 'functional score', 'knee score', 'Low 1-year WOMAC', 'mean of WOMAC score']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}]","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.102828,"The patient's satisfaction score in TKR-H group (4.71 ± 0.46) was significantly higher than the TKR group (4.13 ± 0.45) (P <  0.001) and time to gait aid independent (2.75 ± 0.99 vs. 3.71 ± 1.23, respectively, P = 0.005).
","[{'ForeName': 'Bura', 'Initials': 'B', 'LastName': 'Sindhupakorn', 'Affiliation': 'School of orthopedic, Institute of medicine, Suranaree University of Technology, 111 University Ave, Muang District, Nakhon Ratchasima, Nakhon Ratchasima, 30000, Thailand. bura@sut.ac.th.'}, {'ForeName': 'Piya-On', 'Initials': 'PO', 'LastName': 'Numpaisal', 'Affiliation': 'School of orthopedic, Institute of medicine, Suranaree University of Technology, 111 University Ave, Muang District, Nakhon Ratchasima, Nakhon Ratchasima, 30000, Thailand.'}, {'ForeName': 'Suwittaya', 'Initials': 'S', 'LastName': 'Thienpratharn', 'Affiliation': 'School of orthopedic, Institute of medicine, Suranaree University of Technology, 111 University Ave, Muang District, Nakhon Ratchasima, Nakhon Ratchasima, 30000, Thailand.'}, {'ForeName': 'Darawan', 'Initials': 'D', 'LastName': 'Jomkoh', 'Affiliation': 'School of orthopedic, Institute of medicine, Suranaree University of Technology, 111 University Ave, Muang District, Nakhon Ratchasima, Nakhon Ratchasima, 30000, Thailand.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-019-1412-6']
1293,31797385,Effects of a scalable home-visiting intervention on child development in slums of urban India: evidence from a randomised controlled trial.,"BACKGROUND


An estimated 63.4 million Indian children under 5 years are at risk of poor development. Home visits that use a structured curriculum to help caregivers enhance the quality of the home stimulation environment improve developmental outcomes. However, achieving effectiveness in poor urban contexts through scalable models remains challenging.
METHODS


Using a cluster randomised controlled trial, we evaluated a psychosocial stimulation intervention, comprising weekly home visits for 18 months, in urban slums of Cuttack, Odisha, India. The intervention is complementary to existing early childhood services in India and was run and managed through a local branch of a national NGO. The study ran from August 2013 to July 2015. We enrolled 421 children aged 10-20 months from 54 slums. Slums were randomised to intervention or control. Primary outcomes were children's cognitive, receptive language, expressive language and fine motor development assessed using the Bayley-III. Prespecified intent-to-treat analysis investigated impacts and heterogeneity by gender.
TRIAL REGISTRATIONS


ISRCTN89476603, AEARCTR-0000169.
RESULTS


Endline data for 378 (89.8%) children were analysed. Attrition was balanced between groups. We found improvements of 0.349 of a standard deviation (SD; p = .005, stepdown p = .017) to cognition while impacts on receptive language, expressive language and fine motor development were, respectively, 0.224 SD (p = .099, stepdown p = .184), 0.192 SD (p = .085, stepdown p = .184) and 0.111 (p = .385, stepdown p = .385). A child development factor improved by 0.301 SD (p = .032). Benefits were larger for boys. The quality of the home stimulation environment also improved.
CONCLUSIONS


This study shows that a potentially scalable home-visiting intervention is effective in poor urban areas.",2020,"We found improvements of 0.349 of a standard deviation (SD; p = .005, stepdown","['421 children aged 10-20\xa0months from 54 slums', '18\xa0months, in urban slums of Cuttack, Odisha, India', '63.4 million Indian children under 5\xa0years', 'child development in slums of urban India', 'The study ran from August 2013 to July 2015']","['psychosocial stimulation intervention', 'scalable home-visiting intervention', 'stepdown']","['receptive language, expressive language and fine motor development', ""children's cognitive, receptive language, expressive language and fine motor development assessed using the Bayley-III""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439070', 'cui_str': 'III'}]",421.0,0.130971,"We found improvements of 0.349 of a standard deviation (SD; p = .005, stepdown","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Andrew', 'Affiliation': 'Institute for Fiscal Studies, London, UK.'}, {'ForeName': 'Orazio', 'Initials': 'O', 'LastName': 'Attanasio', 'Affiliation': 'Institute for Fiscal Studies, London, UK.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Augsburg', 'Affiliation': 'Institute for Fiscal Studies, London, UK.'}, {'ForeName': 'Monimalika', 'Initials': 'M', 'LastName': 'Day', 'Affiliation': 'Center for Early Childhood Education and Development, Ambedkar University, Delhi, India.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Grantham-McGregor', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Costas', 'Initials': 'C', 'LastName': 'Meghir', 'Affiliation': 'Institute for Fiscal Studies, London, UK.'}, {'ForeName': 'Fardina', 'Initials': 'F', 'LastName': 'Mehrin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Smriti', 'Initials': 'S', 'LastName': 'Pahwa', 'Affiliation': 'Pratham, Delhi, India.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rubio-Codina', 'Affiliation': 'Inter-American Development Bank, Washington, DC, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13171']
1294,31796827,Expanding the parameter space of anodal transcranial direct current stimulation of the primary motor cortex.,"Size and duration of the neuroplastic effects of tDCS depend on stimulation parameters, including stimulation duration and intensity of current. The impact of stimulation parameters on physiological effects is partially non-linear. To improve the utility of this intervention, it is critical to gather information about the impact of stimulation duration and intensity on neuroplasticity, while expanding the parameter space to improve efficacy. Anodal tDCS of 1-3 mA current intensity was applied for 15-30 minutes to study motor cortex plasticity. Sixteen healthy right-handed non-smoking volunteers participated in 10 sessions (intensity-duration pairs) of stimulation in a randomized cross-over design. Transcranial magnetic stimulation (TMS)-induced motor-evoked potentials (MEP) were recorded as outcome measures of tDCS effects until next evening after tDCS. All active stimulation conditions enhanced motor cortex excitability within the first 2 hours after stimulation. We observed no significant differences between the three stimulation intensities and durations on cortical excitability. A trend for larger cortical excitability enhancements was however observed for higher current intensities (1 vs 3 mA). These results add information about intensified tDCS protocols and suggest that the impact of anodal tDCS on neuroplasticity is relatively robust with respect to gradual alterations of stimulation intensity, and duration.",2019,We observed no significant differences between the three stimulation intensities and durations on cortical excitability.,['Sixteen healthy right-handed non-smoking volunteers'],"['Transcranial magnetic stimulation (TMS)-induced motor-evoked potentials (MEP', 'tDCS']","['stimulation duration and intensity of current', 'cortical excitability', 'motor cortex excitability']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0026607', 'cui_str': 'Somatomotor Areas'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}]",16.0,0.0447522,We observed no significant differences between the three stimulation intensities and durations on cortical excitability.,"[{'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Agboada', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mosayebi Samani', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Jamil', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Min-Fang', 'Initials': 'MF', 'LastName': 'Kuo', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany. nitsche@ifado.de.'}]",Scientific reports,['10.1038/s41598-019-54621-0']
1295,30969147,Trauma-Informed Personalized Scripts to Address Partner Violence and Reproductive Coercion: Preliminary Findings from an Implementation Randomized Controlled Trial.,"Background:  Family planning (FP) providers are in an optimal position to address harmful partner behaviors, yet face several barriers. We assessed the effectiveness of an interactive app to facilitate implementation of patient-provider discussions about intimate partner violence (IPV), reproductive coercion (RC), a wallet-sized educational card, and sexually transmitted infections (STIs).  Materials and Methods:  We randomized participants (English-speaking females, ages 16-29 years) from four FP clinics to two arms: Trauma-Informed Personalized Scripts (TIPS)-Plus and TIPS-Basic. We developed an app that prompted (1) tailored provider scripts (TIPS-Plus and TIPS-Basic) and (2) psychoeducational messages for patients (TIPS-Plus only). Patients completed pre- and postvisit surveys. We compared mean summary scores of IPV, RC, card, and STI discussions between TIPS-Plus and TIPS-Basic using Wilcoxon rank-sum tests, explored predictors with ordinal regression, and compared implementation with historical data using chi-square.  Results:  Of the 240 participants, 47.5% reported lifetime IPV, 12.5% recent IPV, and 7.1% recent RC. No statistically significant differences emerged from summary scores between arms for any outcomes. Several significant predictors were associated with higher scores for patient-provider discussions, including race, reason for visit, contraceptive method, and condom nonuse. Implementation of IPV, RC, and STI discussions increased significantly ( p  < 0.0001) when compared with historical clinical data for both TIPS-Basic and TIPS-Plus.  Conclusions:  We did not find an added benefit of patient activation messages in increasing frequency of sensitive discussions. Several patient characteristics appear to influence providers' likelihood of conversations about harmful partner behaviors. Compared with prior data, this pilot study suggests potential benefits of using provider scripts to guide discussions.",2019,"Implementation of IPV, RC, and STI discussions increased significantly ( p  < 0.0001) when compared with historical clinical data for both TIPS-Basic and TIPS-Plus.  ","['participants (English-speaking females, ages 16-29 years) from four FP clinics to two arms']","[':  Family planning (FP', 'Trauma-Informed Personalized Scripts (TIPS)-Plus and TIPS-Basic']","['Implementation of IPV, RC, and STI discussions', 'lifetime IPV', 'mean summary scores of IPV, RC, card, and STI discussions between TIPS-Plus and TIPS-Basic using Wilcoxon rank-sum tests']","[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0009861', 'cui_str': 'Family Planning Services'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0242928', 'cui_str': 'Rank-Sum Tests'}]",240.0,0.0980201,"Implementation of IPV, RC, and STI discussions increased significantly ( p  < 0.0001) when compared with historical clinical data for both TIPS-Basic and TIPS-Plus.  ","[{'ForeName': 'Amber L', 'Initials': 'AL', 'LastName': 'Hill', 'Affiliation': ""1 Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Zachor', 'Affiliation': '2 Department of Obstetrics and Gynecology, The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Kelley A', 'Initials': 'KA', 'LastName': 'Jones', 'Affiliation': ""1 Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Talis', 'Affiliation': ""1 Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Zelazny', 'Affiliation': '3 Allegheny Health Network Trauma Centers, Allegheny Health Network, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""1 Division of Adolescent and Young Adult Medicine, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}]",Journal of women's health (2002),['10.1089/jwh.2018.7318']
1296,31490321,Economic Evaluation of an Intervention Promoting Adoption of Occupational Sun Protection Policies.,"OBJECTIVE


Economic evaluation of an intervention promoting adoption of occupational sun protection actions by Colorado public sector employers.
METHODS


Randomized controlled trial with 2-year follow-up conducted during 2010 to 2013. Thirty-three intervention and 30 attention-control worksites in final economic sample. Twenty-four-month intervention of personal contacts, training, and materials. Intervention delivery micro-costed. Costs of implemented actions from employer self-report.
RESULTS


Twenty-four-month intervention costs: $121,789, 51.8% incurred by project staff (per-worksite mean=$1,732). Worksite costs: $58,631 (mean = $1,777). Per-employee costs: $118 project staff, $56 worksites. Materials cost: $5990 (mean = $181). Intervention worksites implemented 72 nontraining sun protection actions post-Sun Safe Workplaces (SSW) (mean = 2.18). Control worksites implemented 39 actions (mean = 1.30). Total costs to intervention worksites of implementing the 72 post-SSW actions: $90,645 (mean = $2,747). Control worksite costs: $66,467 (mean = $2,216). Per-employee implementation costs are comparable to other worksite health interventions.
CONCLUSION


SSW expanded adoption of sun protection actions at a reasonable per-employee cost.",2019,"Worksite costs: $58,631 (mean = $1,777).","['2010 to 2013', 'Thirty-three intervention and 30 attention-control worksites in final economic sample']",['Intervention worksites implemented 72 nontraining sun protection actions post-Sun Safe Workplaces (SSW'],"['Control worksite costs', 'Total costs', 'Worksite costs']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",39.0,0.0192676,"Worksite costs: $58,631 (mean = $1,777).","[{'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Meenan', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon (Dr Meenan); Klein Buendel, Inc. Lakewood, Colorado (Dr Walkosz, Dr Buller, Eye, Buller, and Olivas); School of Public Affairs, University of Colorado Denver, Denver, Colorado (Dr Wallis).'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Walkosz', 'Affiliation': ''}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Eye', 'Affiliation': ''}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': ''}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Wallis', 'Affiliation': ''}, {'ForeName': 'Savanna', 'Initials': 'S', 'LastName': 'Olivas', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001707']
1297,31494816,Randomized trial of two after-dialysis gabapentin regimens for severe uremic pruritus in hemodialysis patients.,,2019,,['severe uremic pruritus in hemodialysis patients'],['dialysis gabapentin'],[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}]",[],,0.0237993,,"[{'ForeName': 'Giovanni Maria', 'Initials': 'GM', 'LastName': 'Rossi', 'Affiliation': 'U.O. Nefrologia, Dipartimento di Medicina Generale e Specialistica, Azienda Ospedaliero-Universitaria di Parma, Via Gramsci, 14, Parma, 43126, Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Corradini', 'Affiliation': 'Nephrology and Dialysis Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Blanco', 'Affiliation': ""Renal Unit, Nephrology and Dialysis Department, Sant'Andrea Hospital, La Spezia, Italy.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mattei', 'Affiliation': 'Nephrology and Dialysis Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Fiaccadori', 'Affiliation': 'U.O. Nefrologia, Dipartimento di Medicina Generale e Specialistica, Azienda Ospedaliero-Universitaria di Parma, Via Gramsci, 14, Parma, 43126, Italy.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Vaglio', 'Affiliation': 'Department of Biomedical Clinical and Experimental Sciences ""Mario Serio"", University of Firenze, Florence, Italy.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Manenti', 'Affiliation': 'U.O. Nefrologia, Dipartimento di Medicina Generale e Specialistica, Azienda Ospedaliero-Universitaria di Parma, Via Gramsci, 14, Parma, 43126, Italy. lmanenti1969@gmail.com.'}]",Internal and emergency medicine,['10.1007/s11739-019-02175-4']
1298,30623568,Short-term efficacy of two breast pumps and impact on breastfeeding outcomes at 6 months in exclusively breastfeeding mothers: A randomised trial.,"The provision of breast pumps is a potential strategy to increase breastfeeding duration. This trial compared the effectiveness and acceptability of two breast pumps in mothers exclusively breastfeeding (EBF) their healthy term infant. It also tested whether provision of pumps versus vouchers of equivalent value influenced breastfeeding or attainment of mothers' goals at 3 and 6 months. Mothers were randomised at 3- to 4-week post-partum (Beijing [n = 30], Moscow [n = 34], London [n = 45], New York [n = 3]) to groups A (Philips single-electric pump, Natural bottle), B (Medela Swing single-electric pump, Calma bottle), or C (Control; vouchers). At 6 weeks, group A and B mothers expressed for 10 min/breast; milk weight and opinions of pump/bottle were recorded. Feeding practices were assessed using questionnaires at 3 and 6 months. Milk weight/flow pattern did not differ between groups. Pump A scored significantly better for ease-of-use, cushion-feel, need-to-lean-forward, pleasant, comfort. At 3 and 6 months, %EBF or meeting their goal was not significantly different; (3 months: 86%, 85%, 84%; 6 months: 20%, 15%, 26%; meeting goal 24%, 17%, 27% for A, B, and C). Expressed breast milk (EBM) provision was higher in groups A and B (3 months: 76%, 76%, 24% (p < 0.001); 6 months: 83%, 87%, 32% (p < 0.001); and negatively predicted EBF at 6 months (OR no EBM 5.07, 95% CI [1.56, 16.5]). The pumps were equally effective for milk expression at 6 weeks. Pump provision did not significantly influence breastfeeding practices or attainment of goals but resulted in higher EBM provision, which was associated with lower EBF but not other breastfeeding categories at 6 months.",2019,"Pump A scored significantly better for ease-of-use, cushion-feel, need-to-lean-forward, pleasant, comfort.","['mothers exclusively breastfeeding (EBF) their healthy term infant', 'n\xa0=\xa03', 'exclusively breastfeeding mothers']","['Moscow [n\xa0=\xa034], London [n\xa0=\xa045], New York']","['breastfeeding outcomes', 'Expressed breast milk (EBM) provision', 'EBF', 'effectiveness and acceptability', 'Milk weight/flow pattern']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]","[{'cui': 'C0026580', 'cui_str': 'Moscow'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0027976', 'cui_str': 'New York'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0452739', 'cui_str': 'Expressed breast milk (substance)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",,0.0510971,"Pump A scored significantly better for ease-of-use, cushion-feel, need-to-lean-forward, pleasant, comfort.","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fewtrell', 'Affiliation': 'Childhood Nutrition Research Centre, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Kennedy', 'Affiliation': 'Childhood Nutrition Research Centre, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Lukoyanova', 'Affiliation': ""Department of Nutrition for Sick and Healthy Children, National Medical Research Center of Children's Health of the Ministry of Health of the Russian Federation, Moscow, Russia.""}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': ""Beijing Children's Hospital Affiliated to Capital Medical University, Beijing, China.""}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Potak', 'Affiliation': ""Neonatal Perinatal Medicine, Cohen Children's Medical Center of New York at North Shore, Manhasset, New York, USA.""}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Borovik', 'Affiliation': ""Department of Nutrition for Sick and Healthy Children, National Medical Research Center of Children's Health of the Ministry of Health of the Russian Federation, Moscow, Russia.""}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Namazova-Baranova', 'Affiliation': ""Department of Nutrition for Sick and Healthy Children, National Medical Research Center of Children's Health of the Ministry of Health of the Russian Federation, Moscow, Russia.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schanler', 'Affiliation': ""Neonatal Perinatal Medicine, Cohen Children's Medical Center of New York at North Shore, Manhasset, New York, USA.""}]",Maternal & child nutrition,['10.1111/mcn.12779']
1299,32068418,Mechanisms of change in female-specific and gender-neutral cognitive behavioral therapy for women with alcohol use disorder.,"OBJECTIVE


In a randomized trial for women with alcohol use disorders (AUD), the efficacy of Female-Specific Cognitive Behavioral Therapy (FS-CBT) was compared with Gender-Neutral CBT (GN-CBT; Epstein et al., 2018). The current study examined whether putative mechanisms of change differed between treatment conditions, using a novel statistical approach. Both treatments were hypothesized to work by increasing use of alcohol-related coping skills (coping) and confidence to abstain from drinking (confidence), but FS-CBT additionally targeted female-salient mechanisms: anxiety, depression, sociotropy (i.e., overinvestment in others' opinion of oneself), autonomy, and social networks supportive of abstinence.
METHOD


Ninety-nine women with AUD (55 in GN-CBT, 44 in FS-CBT) completed self-report assessments at baseline and 0, 6, and 12 months posttreatment. Multilevel vector autoregression estimation was used to analyze associations between putative mechanisms of change, and network models of those associations were generated using network analysis.
RESULTS


Across conditions, higher confidence and coping were directly associated with less drinking; autonomy was directly and indirectly associated with drinking. Additionally, network analysis indicated that although variation in depression was associated with change in other variables specifically for GN-CBT, sociotropy was associated with change specifically in FS-CBT.
CONCLUSIONS


Women receiving CBT-AUD changed their drinking through increased confidence to abstain and greater use of coping skills. Autonomy played a central role in behavior change across treatment conditions. Participants receiving treatment tailored to women also changed through decreases in sociotropy and increases in social support for abstinence. For women who received standard CBT, changes in depression were important to clinical improvement. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Both treatments were hypothesized to work by increasing use of alcohol-related coping skills (coping) and confidence to abstain from drinking (confidence), but FS-CBT additionally targeted female-salient mechanisms: anxiety, depression, sociotropy (i.e., overinvestment in others' opinion of oneself), autonomy, and social networks supportive of abstinence.
","['women with alcohol use disorders (AUD', 'women with alcohol use disorder', 'Ninety-nine women with AUD (55 in GN-CBT, 44 in FS-CBT) completed self-report assessments at baseline and 0, 6, and 12 months posttreatment']",['Female-Specific Cognitive Behavioral Therapy (FS-CBT'],['social support for abstinence'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[{'cui': 'C0037438'}],99.0,0.0294468,"Both treatments were hypothesized to work by increasing use of alcohol-related coping skills (coping) and confidence to abstain from drinking (confidence), but FS-CBT additionally targeted female-salient mechanisms: anxiety, depression, sociotropy (i.e., overinvestment in others' opinion of oneself), autonomy, and social networks supportive of abstinence.
","[{'ForeName': 'Cathryn Glanton', 'Initials': 'CG', 'LastName': 'Holzhauer', 'Affiliation': 'Division of Addiction Psychiatry, Department of Psychiatry, University of Massachusetts Medical School.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Epstein', 'Affiliation': 'Division of Addiction Psychiatry, Department of Psychiatry, University of Massachusetts Medical School.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McCrady', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Hallgren', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Center of Alcohol Studies, Rutgers University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000492']
1300,31527020,"Early discontinuation of ethambutol in pulmonary tuberculosis treatment based on results of the GenoType MTBDR plus  assay: A prospective, multicenter, non-inferiority randomized trial in South Korea.","No studies have investigated whether discontinuation of ethambutol (EMB) based on the susceptibility to isoniazid and rifampin as determined by the GenoType MTBDR plus  assay would be appropriate. We aimed to determine the feasibility of discontinuing EMB before the end of intensive phase treatment based on the result of MTBDR plus  assay in patients with pulmonary tuberculosis (PTB). This prospective, multicenter non-inferiority randomized trial was conducted at 12 referral centers in South Korea in drug-susceptible PTB patients who initiated the standard four-drug regimen for PTB. Based on the results of the assay, EMB was discontinued in the MTBDR plus  group after the confirmation that  M. tuberculosis  isolate was susceptible to isoniazid and rifampin. The timepoint for EMB discontinuation in the Guideline group was determined using the results of the phenotypic drug susceptibility test based on the Korean National TB Guidelines. The primary outcome was treatment success. Secondary outcomes included the 1-year rates of recurrence and adverse events. Of 600 randomized patients, the treatment outcome analysis was performed for 493 patients (MTBDR plus  group, 244; Guideline group, 249). Treatment success rates were 93.9% (229/224) in the MTBDR plus  group and 93.6% (233/249) in the Guideline group and did not differ between groups; relative risk 1.00 (95% CI 0.95-1.06). The 1-year recurrence rate between the two groups (0.9% vs. 0.5%, respectively) and differences in adverse drug reactions did not differ between groups. In conclusion, early discontinuation of EMB based on the results of the MTBDR plus  assay did not affect the treatment outcomes in PTB.",2019,"The 1-year recurrence rate between the two groups (0.9% vs. 0.5%, respectively) and differences in adverse drug reactions did not differ between groups.","['12 referral centers in South Korea in drug-susceptible PTB patients who initiated the standard four-drug regimen for PTB', 'patients with pulmonary tuberculosis (PTB', 'South Korea', '493 patients (MTBDR plus  group, 244; Guideline group, 249']",['GenoType MTBDR plus  assay'],"['adverse drug reactions', '1-year recurrence rate', '1-year rates of recurrence and adverse events', 'Treatment success rates']","[{'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}]","[{'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",600.0,0.111131,"The 1-year recurrence rate between the two groups (0.9% vs. 0.5%, respectively) and differences in adverse drug reactions did not differ between groups.","[{'ForeName': 'Kyung-Wook', 'Initials': 'KW', 'LastName': 'Jo', 'Affiliation': 'Division of Pulmonology and Critical Care Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Mihye', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Pulmonary, Allergy and Critical Care Medicine, Gangneung Asan Hospital, Gangneung, South Korea.'}, {'ForeName': 'Ye-Jee', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hyun-Kyung', 'Initials': 'HK', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, South Korea.'}, {'ForeName': 'Hyun Kuk', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Doosoo', 'Initials': 'D', 'LastName': 'Jeon', 'Affiliation': 'Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Jiwon', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, South Korea.'}, {'ForeName': 'Hye Kyeong', 'Initials': 'HK', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Inje University Ilsan Paik Hospital, Inje University College of medicine, Ilsan, South Korea.'}, {'ForeName': 'Jeongha', 'Initials': 'J', 'LastName': 'Mok', 'Affiliation': 'Department of Internal Medicine, Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'Ju Sang', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Incheon, South Korea.'}, {'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Heo', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang Bong', 'Initials': 'SB', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae-Joon', 'Initials': 'JJ', 'LastName': 'Yim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Tae Sun', 'Initials': 'TS', 'LastName': 'Shim', 'Affiliation': 'Division of Pulmonology and Critical Care Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea shimts@amc.seoul.kr.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00980-19']
1301,31548184,High  in vitro  susceptibility to the first-in-class spiropyrimidinetrione zoliflodacin among consecutive clinical  Neisseria gonorrhoeae  isolates from Thailand (2018) and South Africa (2015-2017).,"We evaluated the  in vitro  susceptibility to the first-in-class spiropyrimidinetrione zoliflodacin among recent consecutive clinical  Neisseria gonorrhoeae  isolates cultured in Thailand (n=99; 2018) and South Africa (n=100; 2015-2017). Zoliflodacin was highly active  in vitro  against all tested isolates (MIC range: 0.004-0.25; MIC 50 : 0.064, MIC 90 : 0.125 μg/ml), with no cross-resistance to any of the seven comparator antimicrobials. Our data support the initiation of the global zoliflodacin phase 3 randomized controlled clinical trial for uncomplicated gonorrhea.",2019,"Zoliflodacin was highly active  in vitro  against all tested isolates (MIC range: 0.004-0.25; MIC 50 : 0.064, MIC 90 : 0.125 μg/ml), with no cross-resistance to any of the seven comparator antimicrobials.","['consecutive clinical  Neisseria gonorrhoeae  isolates from Thailand (2018) and South Africa (2015-2017', 'recent consecutive clinical  Neisseria gonorrhoeae  isolates cultured in Thailand (n=99; 2018) and South Africa (n=100; 2015-2017']",['Zoliflodacin'],[],"[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0027573', 'cui_str': 'Gonococcus'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]",[],[],,0.0358983,"Zoliflodacin was highly active  in vitro  against all tested isolates (MIC range: 0.004-0.25; MIC 50 : 0.064, MIC 90 : 0.125 μg/ml), with no cross-resistance to any of the seven comparator antimicrobials.","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Jacobsson', 'Affiliation': 'WHO Collaborating Centre for Gonorrhoea and other STIs, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Ranmini', 'Initials': 'R', 'LastName': 'Kularatne', 'Affiliation': 'Centre for HIV & STIs, National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'Rossaphorn', 'Initials': 'R', 'LastName': 'Kittiyaowamarn', 'Affiliation': 'Bangrak STI Center, Bureau of AIDs TB and STIs, Department of Disease Control, Ministry of Public Health, Bangkok, Thailand.'}, {'ForeName': 'Venessa', 'Initials': 'V', 'LastName': 'Maseko', 'Affiliation': 'Centre for HIV & STIs, National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'Porntip', 'Initials': 'P', 'LastName': 'Paopang', 'Affiliation': 'Bangrak STI Center, Bureau of AIDs TB and STIs, Department of Disease Control, Ministry of Public Health, Bangkok, Thailand.'}, {'ForeName': 'Pongsathorn', 'Initials': 'P', 'LastName': 'Sangprasert', 'Affiliation': 'Bangrak STI Center, Bureau of AIDs TB and STIs, Department of Disease Control, Ministry of Public Health, Bangkok, Thailand.'}, {'ForeName': 'Pachara', 'Initials': 'P', 'LastName': 'Sirivongrangson', 'Affiliation': 'Department of Disease Control, Ministry of Public Health, Bangkok, Thailand.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Piddock', 'Affiliation': 'Global Antibiotic Research & Development Partnership (GARDP), Geneva, Switzerland.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Wi', 'Affiliation': 'Department of Reproductive Health, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Alirol', 'Affiliation': 'Global Antibiotic Research & Development Partnership (GARDP), Geneva, Switzerland.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Unemo', 'Affiliation': 'WHO Collaborating Centre for Gonorrhoea and other STIs, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden magnus.unemo@regionorebrolan.se.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01479-19']
1302,31206639,"Explicit prognostic disclosure to Asian women with breast cancer: A randomized, scripted video-vignette study (J-SUPPORT1601).","BACKGROUND


Nondisclosure of a poor prognosis to patients with advanced cancer remains a typical practice in Asia. Although the importance of prognostic communication has increasingly been recognized worldwide, little is known about whether explicit prognostic disclosure positively affects Asian patients with advanced cancer. The objective of this study was to examine the effects of explicit prognostic communication on patients with cancer recurrence.
METHODS


In this randomized, video-vignette study, Japanese women with breast cancer who had undergone curative surgery viewed videos of prognostic communication between a patient with recurrent, incurable breast cancer and her oncologist. The videos differed only in the presence or absence of explicit prognostic disclosure. The primary outcome was participants' uncertainty (rated from 0 to 10), and the secondary outcomes included anxiety (measured on the State-Trait Anxiety Inventory-State: range, 20-80), satisfaction (Patient Satisfaction Questionnaire; range 0-10), self-efficacy (range, 0-10), and willingness to discuss advance care planning (range, 1-4).
RESULTS


In total, 105 women participated (mean ± SD age, 53.8 ± 8.2 years). After viewing the video with more versus less explicit disclosure, participants showed significantly lower uncertainty (mean ± SE scores, 5.3 ±0.2 vs 5.7 ± 0.2, respectively; P = .032) and higher satisfaction (5.6 ± 0.2 vs 5.2 ± 0.2, respectively; P = .010) without increasing anxiety (changes in scores on the State-Trait Anxiety Inventory-State: 0.06 ± 0.5 vs 0.6 ± 0.5, respectively; P = .198). No significant differences were observed in self-efficacy (5.2 ± 0.2 vs 5.0 ± 0.2, respectively; P = .277) or willingness to discuss advance care planning (2.7 ± 0.1 vs 2.7 ± 0.1, respectively; P = .240).
CONCLUSIONS


Explicit prognostic disclosure prompted better outcomes than nondisclosure in Japanese women with breast cancer. When asked about the prognosis by Asian patients with cancer, clinicians may be encouraged to respect their wishes and explicitly discuss the prognosis if deemed appropriate.",2019,"No significant differences were observed in self-efficacy (5.2 ± 0.2 vs 5.0 ± 0.2, respectively; P = .277) or willingness to discuss advance care planning (2.7 ± 0.1 vs 2.7 ± 0.1, respectively; P = .240).
","['Asian patients with advanced cancer', 'patients with advanced cancer remains a typical practice in Asia', '105 women participated (mean\xa0±\xa0SD age, 53.8\xa0±\xa08.2\xa0years', 'Asian women with breast cancer', 'Japanese women with breast cancer who had undergone curative surgery viewed videos of prognostic communication between a patient with recurrent, incurable breast cancer and her oncologist', 'Japanese women with breast cancer', 'patients with cancer recurrence']",['explicit prognostic communication'],"['anxiety', 'anxiety (measured on the State-Trait Anxiety Inventory-State: range, 20-80), satisfaction (Patient Satisfaction Questionnaire; range 0-10), self-efficacy (range, 0-10), and willingness to discuss advance care planning (range, 1-4', 'self-efficacy', 'higher satisfaction']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",105.0,0.0967885,"No significant differences were observed in self-efficacy (5.2 ± 0.2 vs 5.0 ± 0.2, respectively; P = .277) or willingness to discuss advance care planning (2.7 ± 0.1 vs 2.7 ± 0.1, respectively; P = .240).
","[{'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Palliative Care Team, Seirei Mikatahara General Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Fujimori', 'Affiliation': 'Division of Health Care Research, Behavioral Science and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Liesbeth M', 'Initials': 'LM', 'LastName': 'van Vliet', 'Affiliation': 'Department of Communication, Nivel-Netherlands Institute for Health Services Research, Utrecht, Netherlands.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Shimizu', 'Affiliation': 'Department of Breast Medical Oncology, National Center for Global Health and Medicine, Shinjuku-ku, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Breast Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Morishita-Kawahara', 'Affiliation': 'Division of Health Care Research, Behavioral Science and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Department of Palliative Medicine, Tohoku University School of Medicine, Sendai, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Inoguchi', 'Affiliation': 'Department of Psycho-Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Matsuoka', 'Affiliation': 'Division of Health Care Research, Behavioral Science and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care and Rehabilitation Medicine, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Morita', 'Affiliation': 'Palliative and Supportive Care Division, Seirei Mikatahara General Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Division of Health Care Research, Behavioral Science and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.'}]",Cancer,['10.1002/cncr.32327']
1303,31227390,Impact of Adrenal Hormone Supplementation on Bone Geometry in Growing Teens With Anorexia Nervosa.,"PURPOSE


Adolescents with anorexia nervosa (AN) have decreased dehydroepiandrosterone (DHEA) and estrogen concentrations that may contribute to skeletal deficits. We sought to determine whether DHEA + estrogen replacement (ERT) prevented bone loss in young adolescents with AN.
METHODS


We recruited females with AN (n = 70, ages 11-18 years) into a 12-month, randomized, double-blind placebo-controlled trial. Participants were randomized to oral micronized DHEA 50 mg + 20 mcg ethinyl estradiol/.1 mg levonorgestrel daily (n = 35) or placebo (n = 35). Outcomes included serial measures of bone mineral density (BMD) by dual-energy X-ray absorptiometry (total body, hip, spine) and peripheral quantitative computed tomography (pQCT; tibia). Magnetic resonance imaging of T1-weighted images of the left knee determined physeal status (open/closed).
RESULTS


Sixty-two subjects completed the trial. Physeal closure status was the strongest predictor of aBMD changes. Among girls with open physes, those who received DHEA + ERT showed a decline in BMD Z-scores compared with those receiving placebo, whereas there was no effect in those with at least one closed physis. Treatment did not affect any pQCT measures, regardless of physeal closure status.
CONCLUSIONS


Combined DHEA + ERT did not significantly improve dual-energy X-ray absorptiometry or pQCT BMD measurements in young adolescent girls with AN, in contrast to an earlier trial showing benefit in older adolescents and young women. In girls with open physes, the mean change in the placebo arm was greater than that of the DHEA + ERT group. We conclude that DHEA + ERT is ineffective for preserving bone health in growing young adolescents with AN at the dose and route of administration described in this report.",2019,"Combined DHEA + ERT did not significantly improve dual-energy X-ray absorptiometry or pQCT BMD measurements in young adolescent girls with AN, in contrast to an earlier trial showing benefit in older adolescents and young women.","['Sixty-two subjects completed the trial', 'Growing Teens With Anorexia Nervosa', 'young adolescent girls', 'Adolescents with anorexia nervosa (AN', 'older adolescents and young women', 'young adolescents with AN.\nMETHODS\n\n\nWe recruited females with AN (n\xa0= 70, ages 11-18\xa0years']","['ethinyl estradiol/.1\xa0mg levonorgestrel', 'placebo', 'DHEA\xa0+\xa0ERT', 'oral micronized DHEA 50\xa0mg\xa0', 'Combined DHEA\xa0+ ERT', 'Adrenal Hormone Supplementation', 'DHEA\xa0+ estrogen replacement (ERT']","['BMD Z-scores', 'pQCT measures, regardless of physeal closure status', 'bone loss', 'dual-energy X-ray absorptiometry or pQCT BMD measurements', 'serial measures of bone mineral density (BMD) by dual-energy X-ray absorptiometry (total body, hip, spine) and peripheral quantitative computed tomography (pQCT; tibia']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1445654', 'cui_str': 'Adrenal hormone agent'}, {'cui': 'C0086258', 'cui_str': 'Estrogen Replacements'}]","[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}]",,0.498502,"Combined DHEA + ERT did not significantly improve dual-energy X-ray absorptiometry or pQCT BMD measurements in young adolescent girls with AN, in contrast to an earlier trial showing benefit in older adolescents and young women.","[{'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'DiVasta', 'Affiliation': ""Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts; Division of Gynecology, Boston Children's Hospital, Boston, Massachusetts. Electronic address: amy.divasta@childrens.harvard.edu.""}, {'ForeName': 'Henry A', 'Initials': 'HA', 'LastName': 'Feldman', 'Affiliation': ""Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, Massachusetts; Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': ""O'Donnell"", 'Affiliation': 'Rutgers-Robert Wood Johnson Medical School, Piscataway, New Jersey.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Division of Pediatric Nephrology, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Leonard', 'Affiliation': 'Division of Pediatric Nephrology, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Gordon', 'Affiliation': ""Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts; Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts.""}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.04.003']
1304,31227385,Physical Activity as a Predictor of Changes in Systolic Blood Pressure for African-American Adolescents Seeking Treatment for Obesity.,"PURPOSE


The aim of the study was to examine changes in systolic blood pressure (SBP) and whether physical activity and obesity status predicted SBP change for African-American adolescents (n = 181) participating in a behavioral weight control trial.
METHODS


Data were collected at baseline, 7 months (end-of-treatment), and 9 months (2-month follow-up).
RESULTS


Nearly half of adolescents achieved clinically significant SBP reductions at 7 and 9 months. Significantly, fewer adolescents had elevated SBP at 7 and 9 months compared with baseline (both p < .001). Changes in percent overweight and moderate-to-vigorous activity predicted changes in SBP over time.
CONCLUSIONS


Obesity reduction and increases in moderate-to-vigorous physical activity may predict short-term, clinically meaningful reductions in SBP for African American adolescents with obesity.",2019,"Significantly, fewer adolescents had elevated SBP at 7 and 9 months compared with baseline (both p < .001).","['African-American Adolescents Seeking Treatment for Obesity', 'African-American adolescents (n\xa0= 181) participating in a behavioral weight control trial', 'African American adolescents with obesity']",[],"['systolic blood pressure (SBP', 'Systolic Blood Pressure', 'elevated SBP', 'SBP reductions']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen (regime/therapy)'}]",[],"[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",181.0,0.0184156,"Significantly, fewer adolescents had elevated SBP at 7 and 9 months compared with baseline (both p < .001).","[{'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Towner', 'Affiliation': 'Division of Behavioral Sciences, Department of Family Medicine and Public Health Sciences, Wayne State University School of Medicine, Detroit, Michigan. Electronic address: ekuhl@med.wayne.edu.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Kapur', 'Affiliation': 'Department of Pediatrics, Wayne State University School of Medicine, Detroit, Michigan.'}, {'ForeName': 'April Idalski', 'Initials': 'AI', 'LastName': 'Carcone', 'Affiliation': 'Division of Behavioral Sciences, Department of Family Medicine and Public Health Sciences, Wayne State University School of Medicine, Detroit, Michigan.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Janisse', 'Affiliation': 'Division of Population Health Sciences, Department of Family Medicine and Public Health Sciences, Wayne State University School of Medicine, Detroit, Michigan.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Ellis', 'Affiliation': 'Division of Behavioral Sciences, Department of Family Medicine and Public Health Sciences, Wayne State University School of Medicine, Detroit, Michigan.'}, {'ForeName': 'Kai-Lin', 'Initials': 'KL', 'LastName': 'Catherine Jen', 'Affiliation': 'Department of Nutrition and Food Sciences, Wayne State University, Detroit Michigan.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Naar', 'Affiliation': 'Division of Behavioral Sciences, Department of Family Medicine and Public Health Sciences, Wayne State University School of Medicine, Detroit, Michigan.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.04.001']
1305,31792259,Light therapy with boxes or glasses to counteract effects of acute sleep deprivation.,"Sleep deprivation, in the context of shift work, is an increasing major public health issue. We aimed to determine whether early light administration can counteract sleep deprivation effects, and to compare LED-glasses with a traditional light therapy box. This cross-over design study included 18 individuals exposed to light therapy for 30 minutes at 5 am after one night of complete sleep deprivation, to mimic the night shift condition. Individuals were randomly exposed to 10,000 Lux light box, 2,000 Lux LED blue-enriched glasses, and control (ambient dim-light at 8 lux). Alertness, cognition and mood were assessed throughout the night and following morning. Five women and 13 men (mean 24.78 year old) presented with a progressive and increasing alteration of alertness, cognition, and mood during each sleep deprivation. A rebound was observed at 8 am resulting from the circadian drive overriding cumulative sleep homeostatic effects. Morning light significantly improved sleepiness and sustained attention from 5 to 7 am. These effects were comparable between devices and significantly different from control. Both devices were overall well and similarly tolerated. Early morning light therapy in the condition of sleep loss may have broad practical applications to improve sleepiness, sustained attention and subsequent risk of accidents.",2019,"Five women and 13 men (mean 24.78 year old) presented with a progressive and increasing alteration of alertness, cognition, and mood during each sleep deprivation.","['18 individuals exposed to light therapy for 30\u2009minutes at 5 am after one night of complete sleep deprivation, to mimic the night shift condition', 'Five women and 13 men (mean 24.78 year old) presented with a progressive and increasing alteration of alertness, cognition, and mood during each sleep deprivation']","['Lux light box, 2,000 Lux LED blue-enriched glasses, and control (ambient dim-light at 8 lux']","['sleepiness and sustained attention', 'tolerated', 'Alertness, cognition and mood']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0560137', 'cui_str': 'lux (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention, function (observable entity)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",18.0,0.0260985,"Five women and 13 men (mean 24.78 year old) presented with a progressive and increasing alteration of alertness, cognition, and mood during each sleep deprivation.","[{'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Comtet', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France. henri.comtet@chru-strasbourg.fr.""}, {'ForeName': 'Pierre A', 'Initials': 'PA', 'LastName': 'Geoffroy', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Kobayashi Frisk', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hubbard', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Ludivine', 'Initials': 'L', 'LastName': 'Robin-Choteau', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Calvel', 'Affiliation': 'CNRS UPR 3212, Institute for Cellular and Integrative Neurosciences, 8 rue du Général Rouvillois, 67000, Strasbourg, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Hugueny', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Antoine U', 'Initials': 'AU', 'LastName': 'Viola', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Bourgin', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France.""}]",Scientific reports,['10.1038/s41598-019-54311-x']
1306,30844053,Augmented GLP-1 Secretion as Seen After Gastric Bypass May Be Obtained by Delaying Carbohydrate Digestion.,"CONTEXT


Exaggerated postprandial glucagon-like peptide-1 (GLP-1) secretion seems important for weight loss and diabetes remission after Roux-en-Y gastric bypass (RYGB) and may result from carbohydrate absorption in the distal small intestine.
OBJECTIVE


To investigate distal [GLP-1; peptide YY (PYY)] and proximal [glucose-dependent insulinotropic polypeptide (GIP)] gut hormone secretion in response to carbohydrates hydrolyzed at different rates. We hypothesized that slow digestion restricts proximal absorption, facilitating distal delivery of carbohydrates and thereby enhanced GLP-1 secretion in unoperated individuals, whereas this may not apply after RYGB.
DESIGN


Single-blinded, randomized, crossover study.
SETTING


Hvidovre Hospital, Hvidovre, Denmark.
PARTICIPANTS


Ten RYGB-operated patients and 10 unoperated matched subjects.
INTERVENTIONS


Four separate days with ingestion of different carbohydrate loads, either rapidly/proximally digested (glucose plus fructose; sucrose) or slowly/distally digested (isomaltulose; sucrose plus acarbose).
MAIN OUTCOME MEASURES


GLP-1 secretion (area under the curve above baseline). Secondary outcomes included PYY and GIP.
RESULTS


Isomaltulose enhanced secretion of GLP-1 nearly threefold (P = 0.02) and PYY ninefold (P = 0.08) compared with sucrose in unoperated subjects but had a modest effect after RYGB. Acarbose failed to increase sucrose induced GLP-1 secretion in unoperated subjects and diminished the responses by 50% after RYGB (P = 0.03). In both groups, GIP secretion was reduced by isomaltulose and even more so by sucrose plus acarbose when compared with sucrose intake.
CONCLUSIONS


GLP-1 secretion depends on the rate of carbohydrate digestion, but in a different manner after RYGB. Enhanced GLP-1 secretion is central after RYGB, but it may also be obtained in unoperated individuals by delaying hydrolysis of carbohydrates, pushing their digestion and absorption distally in the small intestine.",2019,Acarbose failed to increase sucrose induced GLP-1 secretion in unoperated subjects and diminished the responses by 50% after RYGB (P = 0.03).,"['Hvidovre Hospital, Hvidovre, Denmark', 'After Gastric Bypass', 'Ten RYGB-operated patients and 10 unoperated matched subjects']","['proximal [glucose-dependent insulinotropic polypeptide (GIP', 'Acarbose', 'ingestion of different carbohydrate loads, either rapidly/proximally digested (glucose plus fructose; sucrose) or slowly/distally digested (isomaltulose; sucrose plus acarbose', 'sucrose plus acarbose']","['PYY and GIP', 'weight loss and diabetes remission', 'rate of carbohydrate digestion', 'GLP-1 secretion', 'secretion of GLP-1', 'GIP secretion', 'sucrose induced GLP-1 secretion']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0064002', 'cui_str': 'isomaltulose anhydrous'}]","[{'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0012238', 'cui_str': 'Digestion'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",,0.0294462,Acarbose failed to increase sucrose induced GLP-1 secretion in unoperated subjects and diminished the responses by 50% after RYGB (P = 0.03).,"[{'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Martinussen', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Kristine Nyvold', 'Initials': 'KN', 'LastName': 'Bojsen-Møller', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Dirksen', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Maria Saur', 'Initials': 'MS', 'LastName': 'Svane', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Viggo Bjerregaard', 'Initials': 'VB', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Surgical Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-02661']
1307,31781700,Changes of the alveolar ridge dimension and gingival recession associated with implant position and tissue phenotype with immediate implant placement: A randomised controlled clinical trial.,"PURPOSE


This prospective, randomised, controlled clinical trial evaluated the relationship between alveolar ridge dimensional change and recession with the implant position (horizontal and vertical) and tissue phenotype in immediately placed and provisionalised implants without the use of bone grafting.
MATERIALS AND METHODS


Patients (n = 40) with a hopeless maxillary anterior tooth received an immediate implant and immediate provisional or customised healing abutment after flapless extraction. Implants were finally restored 3 months after placement and followed up for 6 months after delivery of the restoration. The alveolar ridge dimensional change and recession were measured using cone beam computed tomography (CBCT) scans and digitalised dental casts. Alveolar contour changes were correlated to implant position and tissue phenotype.
RESULTS


The tissue phenotype showed no significant correlation to the alveolar ridge dimensional change. At 6 months, the average alveolar ridge dimensional change was approximately 0.7 mm in the buccolingual dimension independent of tissue phenotype. A statistically significant difference was observed on the recession values comparing tissue phenotypes, with more recession observed in the thin phenotype (1.96 mm) than in the thick phenotype (1.18 mm). A significant correlation was observed between horizontal implant position and buccolingual alveolar ridge change. A positive correlation was observed between the horizontal implant position and the dimensional change measured in the casts at the level of the free gingival margin. A statistically significant negative correlation was observed between the horizontal implant position and the resorption measured by the CBCT scans.
CONCLUSIONS


Patients with thin tissue phenotype had a more marked recession. The horizontal implant position showed a relationship to the alveolar ridge dimensional changes observed. The greater the buccal gap distance between the implant and the buccal plate, the lesser the radiographic changes observed in the alveolar bone, however, the greater the changes observed in the buccal aspect of the casts at the level of the free gingival margin.",2019,"A statistically significant difference was observed on the recession values comparing tissue phenotypes, with more recession observed in the thin phenotype (1.96 mm) than in the thick phenotype (1.18 mm).",['Patients (n = 40) with a hopeless maxillary anterior tooth received an'],"['immediate implant and immediate provisional or customised healing abutment after flapless extraction', 'immediate implant placement']","['average alveolar ridge dimensional change', 'Alveolar contour changes', 'alveolar ridge dimensional change and recession', 'alveolar ridge dimensional change', 'horizontal implant position and buccolingual alveolar ridge change', 'buccal gap distance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C3266125', 'cui_str': 'Healing abutment (physical object)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure (body structure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",,0.0243851,"A statistically significant difference was observed on the recession values comparing tissue phenotypes, with more recession observed in the thin phenotype (1.96 mm) than in the thick phenotype (1.18 mm).","[{'ForeName': 'Nurit', 'Initials': 'N', 'LastName': 'Bittner', 'Affiliation': ''}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schulze-Späte', 'Affiliation': ''}, {'ForeName': 'Cleber', 'Initials': 'C', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Da Silva', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Tarnow', 'Affiliation': ''}, {'ForeName': 'Mindy S', 'Initials': 'MS', 'LastName': 'Gil', 'Affiliation': ''}, {'ForeName': 'Shigemi', 'Initials': 'S', 'LastName': 'Ishikawa-Nagai', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1308,30689800,"Platelet inhibition with standard vs. lower maintenance dose of ticagrelor early after myocardial infarction (ELECTRA): a randomized, open-label, active-controlled pharmacodynamic and pharmacokinetic study.","AIMS


Currently available data indicate that reduction of ticagrelor maintenance dose (MD) 1-3 years after acute myocardial infarction (AMI) not only provides sufficient platelet inhibition but also can improve ticagrelor's safety profile. The aim of this study was to compare the antiplatelet effect of reduced and standard ticagrelor MD in stable patients beginning 1 month after AMI.
METHODS AND RESULTS


In a single-centre, randomized, open-label, active-controlled trial, on Day 30 following AMI, 52 patients (26 in each study arm) were assigned in a 1:1 ratio to receive either reduced (60 mg b.i.d) or standard (90 mg b.i.d) ticagrelor MD for the following 2 weeks. On Day 45 after AMI the antiplatelet effect of ticagrelor was evaluated with the VASP assay and Multiplate, and there were no significant differences in platelet inhibition between patients on reduced vs. standard MD [VASP: 10.4 (5.6-22.2) vs. 14.1 (9.4-22.1) platelet reactivity index; P = 0.30; Multiplate: 30.0 (24.0-39.0) vs. 26.5 (22.0-35.0) U; P = 0.26]. Likewise, no differences were found regarding the prevalence of on-ticagrelor high platelet reactivity between patients on ticagrelor 60 mg b.i.d vs. 90 mg b.i.d (VASP: 4% vs. 8%; P = 0.67; Multiplate: 15% vs. 8%; P = 0.54). Administration of reduced MD resulted in proportionally lower plasma concentrations of ticagrelor and its active metabolite on Day 45 after AMI.
CONCLUSION


These results suggest that lowering ticagrelor MD 1 month after AMI confers an adequate antiplatelet effect that is comparable to the standard dose. The tested strategy warrants further research to assess its clinical efficacy and safety.
CLINICALTRIALS.GOV IDENTIFIER


NCT03251859.",2019,"Administration of reduced MD resulted in proportionally lower plasma concentrations of ticagrelor and its active metabolite on Day 45 after AMI.
",['stable patients beginning 1 month after AMI'],"['standard ticagrelor MD', 'standard (90\u2009mg b.i.d) ticagrelor MD', 'ticagrelor']","['prevalence of on-ticagrelor high platelet reactivity', 'plasma concentrations of ticagrelor and its active metabolite', 'platelet inhibition', 'Platelet inhibition', 'clinical efficacy and safety']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0464961,"Administration of reduced MD resulted in proportionally lower plasma concentrations of ticagrelor and its active metabolite on Day 45 after AMI.
","[{'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kubica', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, 13-15 Jagiellońska Street, 85-067 Bydgoszcz, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Adamski', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, 13-15 Jagiellońska Street, 85-067 Bydgoszcz, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Buszko', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, 13-15 Jagiellońska Street, 85-067 Bydgoszcz, Poland.'}, {'ForeName': 'Malwina', 'Initials': 'M', 'LastName': 'Barańska', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, 13-15 Jagiellońska Street, 85-067 Bydgoszcz, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Sikora', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, 13-15 Jagiellońska Street, 85-067 Bydgoszcz, Poland.'}, {'ForeName': 'Michał Piotr', 'Initials': 'MP', 'LastName': 'Marszałł', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, 13-15 Jagiellońska Street, 85-067 Bydgoszcz, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Sobczak', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, 13-15 Jagiellońska Street, 85-067 Bydgoszcz, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sikora', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, 13-15 Jagiellońska Street, 85-067 Bydgoszcz, Poland.'}, {'ForeName': 'Wiktor', 'Initials': 'W', 'LastName': 'Kuliczkowski', 'Affiliation': 'Department and Clinic of Cardiology, Wrocław Medical University, 213 Borowska Street, Wroclaw 50-556, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Fabiszak', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, 13-15 Jagiellońska Street, 85-067 Bydgoszcz, Poland.'}, {'ForeName': 'Aldona', 'Initials': 'A', 'LastName': 'Kubica', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, 13-15 Jagiellońska Street, 85-067 Bydgoszcz, Poland.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Jilma', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Waehringer Guertel 18-20, Vienna 1090, Austria.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Alexopoulos', 'Affiliation': '2nd Department of Cardiology, National and Capodistrian University of Athens, Attikon University Hospital, Rimini 1, Athens 12462, Greece.'}, {'ForeName': 'Eliano Pio', 'Initials': 'EP', 'LastName': 'Navarese', 'Affiliation': 'Collegium Medicum, Nicolaus Copernicus University, 13-15 Jagiellońska Street, 85-067 Bydgoszcz, Poland.'}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz004']
1309,31775650,Enhanced coordination of care to reduce medication risks in older home care clients in primary care: a randomized controlled trial.,"BACKGROUND


As populations are aging, a growing number of home care clients are frail and use multiple, complex medications. Combined with the lack of coordination of care this may pose uncontrolled polypharmacy and potential patient safety risks. The aim of this study was to assess the impact of a care coordination intervention on medication risks identified in drug regimens of older home care clients over a one-year period.
METHODS


Two-arm, parallel, cluster randomized controlled trial with baseline and follow-up assessment at 12 months. The study was conducted in Primary Care in Lohja, Finland: all 5 home care units, the public healthcare center, and a private community pharmacy.
PARTICIPANTS


All consented home care clients aged > 65 years, using at least one prescription medicine who were assessed at baseline and at 12 months.
INTERVENTION


Practical nurses were trained to make the preliminary medication risk assessment during home visits and report findings to the coordinating pharmacist. The coordinating pharmacist prepared the cases for the triage meeting with the physician and home care nurse to decide on further actions. Each patient's physician made the final decisions on medication changes needed. Outcomes were measured as changes in medication risks: use of potentially inappropriate medications and psychotropics; anticholinergic and serotonergic load; drug-drug interactions.
RESULTS


Participants (n = 129) characteristics: mean age 82.8 years, female 69.8%, mean number of prescription medicines in use 13.1. The intervention did not show an impact on the medication risks between the original intervention group and the control group in the intention to treat analysis, but the per protocol analysis indicated tendency for effectiveness, particularly in optimizing central nervous system medication use. Half (50.0%) of the participants with a potential need for medication changes, agreed on in the triage meeting, had none of the medication changes actually implemented.
CONCLUSION


The care coordination intervention used in this study indicated tendency for effectiveness when implemented as planned. Even though the outcome of the intervention was not optimal, the value of this paper is in discussing the real world experiences and challenges of implementing new practices in home care.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02545257). Registered September 9 2015.",2019,"The intervention did not show an impact on the medication risks between the original intervention group and the control group in the intention to treat analysis, but the per protocol analysis indicated tendency for effectiveness, particularly in optimizing central nervous system medication use.","['Participants (n\u2009=\u2009129) characteristics: mean age 82.8\u2009years, female 69.8%, mean number of prescription medicines in use 13.1', 'older home care clients in primary care', 'Primary Care in Lohja, Finland: all 5 home care units, the public healthcare center, and a private community pharmacy', 'older home care clients over a one-year period', 'All consented home care clients aged >\u200965\u2009years, using at least one prescription medicine who were assessed at baseline and at 12\u2009months']",['care coordination intervention'],"['medication risks', 'changes in medication risks: use of potentially inappropriate medications and psychotropics; anticholinergic and serotonergic load; drug-drug interactions']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C4042848', 'cui_str': 'Potentially Inappropriate Medications'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.032924,"The intervention did not show an impact on the medication risks between the original intervention group and the control group in the intention to treat analysis, but the per protocol analysis indicated tendency for effectiveness, particularly in optimizing central nervous system medication use.","[{'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Toivo', 'Affiliation': 'Faculty of Pharmacy, Division of Pharmacology and Pharmacotherapy, Clinical Pharmacy Group, University of Helsinki, Viikinkaari 5 E, P.O. BOX 56, 00014, Helsinki, Finland. terhi.toivo@helsinki.fi.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Airaksinen', 'Affiliation': 'Faculty of Pharmacy, Division of Pharmacology and Pharmacotherapy, Clinical Pharmacy Group, University of Helsinki, Viikinkaari 5 E, P.O. BOX 56, 00014, Helsinki, Finland.'}, {'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Dimitrow', 'Affiliation': 'Faculty of Pharmacy, Division of Pharmacology and Pharmacotherapy, Clinical Pharmacy Group, University of Helsinki, Viikinkaari 5 E, P.O. BOX 56, 00014, Helsinki, Finland.'}, {'ForeName': 'Eeva', 'Initials': 'E', 'LastName': 'Savela', 'Affiliation': '1st Pharmacy of Lohja, Laurinkatu 37-41 A, 08100, Turku, Finland.'}, {'ForeName': 'Katariina', 'Initials': 'K', 'LastName': 'Pelkonen', 'Affiliation': 'City of Lohja, Services for Aged Residents, PL 71, 08101, Lohja, Finland.'}, {'ForeName': 'Valtteri', 'Initials': 'V', 'LastName': 'Kiuru', 'Affiliation': 'City of Lohja, Services for Aged Residents, PL 71, 08101, Lohja, Finland.'}, {'ForeName': 'Tuula', 'Initials': 'T', 'LastName': 'Suominen', 'Affiliation': 'City of Lohja, Services for Aged Residents, PL 71, 08101, Lohja, Finland.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Uunimäki', 'Affiliation': 'City of Lohja, Services for Aged Residents, PL 71, 08101, Lohja, Finland.'}, {'ForeName': 'Sirkka-Liisa', 'Initials': 'SL', 'LastName': 'Kivelä', 'Affiliation': 'Faculty of Pharmacy, Division of Pharmacology and Pharmacotherapy, Clinical Pharmacy Group, University of Helsinki, Viikinkaari 5 E, P.O. BOX 56, 00014, Helsinki, Finland.'}, {'ForeName': 'Saija', 'Initials': 'S', 'LastName': 'Leikola', 'Affiliation': '1st Pharmacy of Lohja, Laurinkatu 37-41 A, 08100, Turku, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Puustinen', 'Affiliation': 'Faculty of Pharmacy, Division of Pharmacology and Pharmacotherapy, Clinical Pharmacy Group, University of Helsinki, Viikinkaari 5 E, P.O. BOX 56, 00014, Helsinki, Finland.'}]",BMC geriatrics,['10.1186/s12877-019-1353-2']
1310,31231758,A Single Dose of Dietary Nitrate Increases Maximal Knee Extensor Angular Velocity and Power in Healthy Older Men and Women.,"BACKGROUND


Aging results in reductions in maximal muscular strength, speed, and power, which often lead to functional limitations highly predictive of disability, institutionalization, and mortality in elderly adults. This may be partially due to reduced nitric oxide (NO) bioavailability. We, therefore, hypothesized that dietary nitrate (NO3-), a source of NO via the NO3- → nitrite (NO2-) → NO enterosalivary pathway, could increase muscle contractile function in older subjects.
METHODS


Twelve healthy older (age 71 ± 5 years) men and women were studied using a randomized, double-blind, placebo-controlled, crossover design. After fasting overnight, subjects were tested 2 hours after ingesting beetroot juice containing or devoid of 13.4 ± 1.6 mmol NO3-. Plasma NO3- and NO2- and breath NO were measured periodically, and muscle function was determined using isokinetic dynamometry.
RESULTS


N O 3 - ingestion increased (p < .001) plasma NO3-, plasma NO2-, and breath NO by 1,051% ± 433%, 138% ± 149%, and 111% ± 115%, respectively. Maximal velocity of knee extension increased (p < .01) by 10.9% ± 12.1%. Maximal knee extensor power increased (p < .05) by 4.4% ± 7.8%.
CONCLUSIONS


Acute dietary NO3- intake improves maximal knee extensor angular velocity and power in older individuals. These findings may have important implications for this population, in whom diminished muscle function can lead to functional limitations, dependence, and even premature death.",2020,"RESULTS


NO3- ingestion increased (P<0.001) plasma NO3-, plasma NO2 , and","['healthy older men and women', 'y) men and women', 'older subjects', 'Twelve healthy older (age 71±5', 'older individuals']","['dietary nitrate', 'dietary nitrate (NO3', 'Acute dietary NO3- intake', 'placebo']","['Plasma NO3- and NO2 and breath NO', 'maximal knee extensor angular velocity and power', 'Maximal knee extensor power', 'maximal knee extensor angular velocity', 'NO3- ingestion increased (P<0.001) plasma NO3-, plasma NO2 , and', 'nitric oxide (NO) bioavailability', 'Maximal velocity of knee extension']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]",12.0,0.0826662,"RESULTS


NO3- ingestion increased (P<0.001) plasma NO3-, plasma NO2 , and","[{'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Coggan', 'Affiliation': 'Department of Kinesiology, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Hoffman', 'Affiliation': 'Department of Kinesiology, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Derrick A', 'Initials': 'DA', 'LastName': 'Gray', 'Affiliation': 'Department of Kinesiology, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Ranjani N', 'Initials': 'RN', 'LastName': 'Moorthi', 'Affiliation': 'Department of Internal Medicine, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Deepak P', 'Initials': 'DP', 'LastName': 'Thomas', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Leibowitz', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Dakkota', 'Initials': 'D', 'LastName': 'Thies', 'Affiliation': 'Department of Radiology, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz156']
1311,31220256,"Controlling intestinal colonization of high-risk haematology patients with ESBL-producing Enterobacteriaceae: a randomized, placebo-controlled, multicentre, Phase II trial (CLEAR).","OBJECTIVES


We assessed the efficacy and safety of an oral antimicrobial regimen for short- and long-term intestinal eradication of ESBL-producing Escherichia coli and Klebsiella pneumoniae (ESBL-EC/KP) in immunocompromised patients.
METHODS


We performed a randomized (2:1), double-blind multicentre Phase II study in four haematology-oncology departments. Patients colonized with ESBL-EC/KP received a 7 day antimicrobial regimen of oral colistin (2 × 106 IU 4×/day), gentamicin (80 mg 4×/day) and fosfomycin (three administrations of 3 g every 72 h), or placebo. Faecal, throat and urine specimens were collected on day 0, 6 ± 2, 11 ± 2, 28 ± 4 and 42 ± 4 after treatment initiation, and the quantitative burden of ESBL-EC/KP, resistance genes and changes in intestinal microbiota were analysed. Clinicaltrials.gov: NCT01931592.
RESULTS


As the manufacture of colistin powder was suspended worldwide, the study was terminated prematurely. Overall, 29 (18 verum/11 placebo) out of 47 patients were enrolled. The short-term intestinal eradication was marginal at day 6 (verum group 15/18, 83.3% versus placebo 2/11, 18.2%; relative risk 4.58, 95% CI 1.29-16.33; Fisher's exact test P = 0.001) and not evident at later timepoints. Quantitative analysis showed a significant decrease of intestinal ESBL-EC/KP burden on day 6. Sustained intestinal eradication (day 28 + 42) was not achieved (verum, 38.9% versus placebo, 27.3%; P = 0.299). In the verum group, mcr-1 genes were detected in two faecal samples collected after treatment. Microbiome analysis showed a significant decrease in alpha diversity and a shift in beta diversity.
CONCLUSIONS


In this prematurely terminated study of a 7 day oral antimicrobial eradication regimen, short-term ESBL-EC/KP suppression was marginal, while an altered intestinal microbiota composition was clearly apparent.",2019,"The short-term intestinal eradication was marginal at day 6 (verum group 15/18, 83.3% versus placebo 2/11, 18.2%; relative risk 4.58, 95% CI 1.29-16.33; Fisher's exact test P = 0.001) and not evident at later timepoints.","['four haematology-oncology departments', 'high-risk haematology patients with ESBL-producing Enterobacteriaceae', '47 patients were enrolled', 'immunocompromised patients']","['placebo', 'gentamicin (80\u2009mg 4×/day) and fosfomycin', 'ESBL-producing Escherichia coli and Klebsiella pneumoniae (ESBL-EC/KP', 'oral colistin', 'oral antimicrobial regimen']","['intestinal ESBL-EC/KP burden', 'Faecal, throat and urine specimens', 'quantitative burden of ESBL-EC/KP, resistance genes and changes in intestinal microbiota', 'Sustained intestinal eradication', 'efficacy and safety', 'short-term intestinal eradication', 'intestinal microbiota composition', 'alpha diversity and a shift in beta diversity']","[{'cui': 'C1274119', 'cui_str': 'Haematology (specialty)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444096', 'cui_str': 'Extended spectrum beta-lactamase producing bacteria'}, {'cui': 'C0014346', 'cui_str': 'Coliform Bacilli'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C1444096', 'cui_str': 'Extended spectrum beta-lactamase producing bacteria'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0001699', 'cui_str': 'Klebsiella pneumoniae'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1444096', 'cui_str': 'Extended spectrum beta-lactamase producing bacteria'}, {'cui': 'C0230069', 'cui_str': 'Structure of anterior portion of neck'}, {'cui': 'C0042037'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]",47.0,0.534434,"The short-term intestinal eradication was marginal at day 6 (verum group 15/18, 83.3% versus placebo 2/11, 18.2%; relative risk 4.58, 95% CI 1.29-16.33; Fisher's exact test P = 0.001) and not evident at later timepoints.","[{'ForeName': 'Vassiliki', 'Initials': 'V', 'LastName': 'Dimitriou', 'Affiliation': 'Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Lena M', 'Initials': 'LM', 'LastName': 'Biehl', 'Affiliation': 'Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hamprecht', 'Affiliation': 'German Center for Infection Research (DZIF), partner site Bonn-Cologne, Cologne, Germany.'}, {'ForeName': 'Wichard', 'Initials': 'W', 'LastName': 'Vogel', 'Affiliation': 'Department of Oncology, Haematology, Immunology, Rheumatology and Pulmonology, Internal Medicine II, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Dörfel', 'Affiliation': 'Department of Oncology, Haematology, Immunology, Rheumatology and Pulmonology, Internal Medicine II, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Peter', 'Affiliation': 'Institute of Medical Microbiology and Hygiene, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'Department of Oncology and Haematology, Hubertus Wald Tumorzentrum/University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Rohde', 'Affiliation': 'Institute for Medical Microbiology, Virology and Hygiene, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'von Lilienfeld-Toal', 'Affiliation': 'Department of Haematology and Medical Oncology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Tilman E', 'Initials': 'TE', 'LastName': 'Klassert', 'Affiliation': 'Host Septomics Research Group, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Slickers', 'Affiliation': 'Abbott (Alere Technologies GmbH), Jena, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Ehricht', 'Affiliation': 'Center for Applied Research, InfectoGnostics Research Campus, Jena, Germany.'}, {'ForeName': 'Hortense', 'Initials': 'H', 'LastName': 'Slevogt', 'Affiliation': 'Host Septomics Research Group, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Hildegard', 'Initials': 'H', 'LastName': 'Christ', 'Affiliation': 'Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Fedja', 'Initials': 'F', 'LastName': 'Farowski', 'Affiliation': 'Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Tsakmaklis', 'Affiliation': 'Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Higgins', 'Affiliation': 'German Center for Infection Research (DZIF), partner site Bonn-Cologne, Cologne, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Seifert', 'Affiliation': 'German Center for Infection Research (DZIF), partner site Bonn-Cologne, Cologne, Germany.'}, {'ForeName': 'Maria J G T', 'Initials': 'MJGT', 'LastName': 'Vehreschild', 'Affiliation': 'Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz124']
1312,31213079,Phenomapping of subgroups in hypertensive patients using unsupervised data-driven cluster analysis: An exploratory study of the SPRINT trial.,"BACKGROUND


Hypertensive patients are highly heterogeneous in cardiovascular prognosis and treatment responses. A better classification system with phenomapping of clinical features would be of greater value to identify patients at higher risk of developing cardiovascular outcomes and direct individual decision-making for antihypertensive treatment.
METHODS


An unsupervised, data-driven cluster analysis was performed for all baseline variables related to cardiovascular outcomes and treatment responses in subjects from the Systolic Blood Pressure Intervention Trial (SPRINT), in order to identify distinct subgroups with maximal within-group similarities and between-group differences. Cox regression was used to calculate hazard ratios (HRs) with 95% confidence intervals (CIs) for cardiovascular outcomes and compare the effect of intensive antihypertensive treatment in different clusters.
RESULTS


Four replicable clusters of patients were identified: cluster 1 (index hypertensives); cluster 2 (chronic kidney disease hypertensives); cluster 3 (obese hypertensives) and cluster 4 (extra risky hypertensives). In terms of prognosis, individuals in cluster 4 had the highest risk of developing primary outcomes. In terms of treatment responses, intensive antihypertensive treatment was shown to be beneficial only in cluster 4 (HR 0.73, 95% CI 0.55-0.98) and cluster 1 (HR 0.54, 95% CI 0.37-0.79) and was associated with an increased risk of severe adverse effects in cluster 2 (HR 1.18, 95% CI 1.05-1.32).
CONCLUSION


Using a data-driven approach, SPRINT subjects can be stratified into four phenotypically distinct subgroups with different profiles on cardiovascular prognoses and responses to intensive antihypertensive treatment. Of note, these results should be taken as hypothesis generating that warrant further validation in future prospective studies.",2019,"In terms of treatment responses, intensive antihypertensive treatment was shown to be beneficial only in cluster 4 (HR 0.73, 95% CI 0.55-0.98) and cluster 1 (HR 0.54, 95% CI 0.37-0.79) and was associated with an increased risk of severe adverse effects in cluster 2 (HR 1.18, 95% CI 1.05-1.32).
","['Four replicable clusters of patients were identified: cluster 1 (index hypertensives); cluster 2 (chronic kidney disease hypertensives); cluster 3 (obese hypertensives) and cluster 4 (extra risky hypertensives', 'hypertensive patients', 'Hypertensive patients']",[],['risk of severe adverse effects'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0722798,"In terms of treatment responses, intensive antihypertensive treatment was shown to be beneficial only in cluster 4 (HR 0.73, 95% CI 0.55-0.98) and cluster 1 (HR 0.54, 95% CI 0.37-0.79) and was associated with an increased risk of severe adverse effects in cluster 2 (HR 1.18, 95% CI 1.05-1.32).
","[{'ForeName': 'Da-Ya', 'Initials': 'DY', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}, {'ForeName': 'Zhi-Qiang', 'Initials': 'ZQ', 'LastName': 'Nie', 'Affiliation': 'Guangdong Cardiovascular Institute, Guangdong Provincial Hospital, China.'}, {'ForeName': 'Li-Zhen', 'Initials': 'LZ', 'LastName': 'Liao', 'Affiliation': 'Department of Health, Guangdong Pharmaceutical University, China.'}, {'ForeName': 'Shao-Zhao', 'Initials': 'SZ', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}, {'ForeName': 'Hui-Min', 'Initials': 'HM', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}, {'ForeName': 'Xiu-Ting', 'Initials': 'XT', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}, {'ForeName': 'Xiang-Bin', 'Initials': 'XB', 'LastName': 'Zhong', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}, {'ForeName': 'Zhi-Min', 'Initials': 'ZM', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Zhuang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}, {'ForeName': 'Xin-Xue', 'Initials': 'XX', 'LastName': 'Liao', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, China.'}]",European journal of preventive cardiology,['10.1177/2047487319856733']
1313,31781698,Immediate versus conventional loading of mandibular implant-supported fixed prostheses in edentulous patients: 10-year report of a randomised controlled trial.,"PURPOSE


To compare the clinical outcomes of immediate versus conventional delayed loading of four dental implants in edentulous mandibles with fixed prostheses.
MATERIALS AND METHODS


A blinded, two-arm, parallel group, randomised controlled trial was conducted. A total of 42 patients were included, and each received four Brånemark System implants with a TiUnite surface. The patients were randomly assigned to two study arms: 1) immediate-loading arm (IL), in which the mandibular denture was converted into an interim implant-supported fixed prosthesis (ISFP) on the day of surgery, with a permanent ISFP being inserted at least 3 months postsurgery; 2) conventional-loading arm (CL), in which the mandibular removable prosthesis was relieved at the implant site and relined with a soft tissue conditioner. Only implants with a minimum insertion torque of ≥ 35 Ncm were included in the IL group. Implants were loaded 4 to 6 months postsurgery. Independent, blind investigators assessed the patients at 2, 6 and 12 months and at 10 years. The outcome measures were prosthesis and implant success rates, type and frequency of complications and changes in peri-implant marginal bone levels.
RESULTS


A total of 20 patients were allocated to the IL group and 22 to the CL group. However, one patient from the IL arm was excluded and three patients were reallocated to the CL arm. Two implants in one patient and one in another patient could not be placed with a ≥ 35 Ncm insertion torque, and a third patient developed severe sudden gag reflex and thus it was not possible to load the implants immediately. At a later stage, one of the patients who failed the initial stability test dropped out of the study. Therefore, initially, 24 patients were conventionally loaded and 16 patients were immediately loaded. At the 10-year follow-up, six patients dropped out from the IL arm and two from the CL arm. Also, at the 10-year-follow-up, the CL and IL study arms consisted of 22 and 10 participants, respectively, using the per-protocol (PP) analysis. Six implants failed in two patients of the CL arm (two implants in one patient and four implants in another patient), and three implants failed in three patients in the IL arm (PP analysis), respectively. The patient-level implant failure rate was 10% (intention-to-treat [ITT] analysis) and 14% (PP analysis) in the CL arm, and 25% (ITT) and 20% (PP) in the IL arm. The difference was not statistically significant (95% CI from -0.18 to 0.39, P = 0.65). The failure rate at the implant level was 8% (ITT) and 8% (PP) in the CL arm, and 6% (ITT) and 5% (PP) in the IL arm. The difference was not statistically significant (95% CI from -0.06 to 0.14, P = 0.44). Ten years after loading, patients in the IL arm lost an average of 0.55 ± 0.64 mm of peri-implant bone versus 0.41 ± 0.40 mm of peri-implant bone loss observed in the CL arm. The 10-year bone loss in both arms was statistically significant compared with the baseline (P < 0.001). However, there was no statistically significant difference between the two arms for peri-implant bone level changes (the difference between the arms was 0.14 mm ± 0.50 mm; 95% CI -0.23 to 0.52; P = 0.43). One prosthesis failed due to the loss of all four implants in one patient of the CL arm. Eight patients from the IL arm were affected by 13 complications (such as pain from fractures and inflammation) versus seven patients (10 complications) from the CL arm. The complication rate was 67% in the IL arm and 35% in the CL arm. The difference in complication proportions between the two arms was not statistically significant (difference in proportions = 0.32; 95% CI = -0.08 to 0.61; P = 0.14). All complications were managed successfully.
CONCLUSIONS


Long-term data of immediate loading of four dental implants with a mandibular fixed prosthesis revealed comparable clinical outcomes to conventional loading. Therefore, immediate loading should be considered in the treatment of edentulous patients.",2019,"The failure rate at the implant level was 8% (ITT) and 8% (PP) in the CL arm, and 6% (ITT) and 5% (PP) in the IL arm.","['edentulous patients', 'edentulous mandibles with fixed prostheses', '20 patients were allocated to the IL group and 22 to the CL group', 'A total of 42 patients', '24 patients were conventionally loaded and 16 patients were immediately loaded']","['immediate versus conventional delayed loading of four dental implants', 'immediate-loading arm (IL), in which the mandibular denture was converted into an interim implant-supported fixed prosthesis (ISFP) on the day of surgery, with a permanent ISFP being inserted at least 3 months postsurgery; 2) conventional-loading arm (CL', 'conventional loading of mandibular implant-supported fixed prostheses']","['peri-implant bone level changes', 'failure rate at the implant level', 'complication proportions', 'severe sudden gag reflex', '10-year bone loss', 'patient-level implant failure rate', 'prosthesis and implant success rates, type and frequency of complications and changes in peri-implant marginal bone levels', 'complication rate']","[{'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853359', 'cui_str': 'Edentulous mandible'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0011373', 'cui_str': 'Dental Implants'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1276802', 'cui_str': 'Sudden onset'}, {'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0854676', 'cui_str': 'Failure of implant'}, {'cui': 'C0524929', 'cui_str': 'Prosthetic Implants'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}]",,0.206047,"The failure rate at the implant level was 8% (ITT) and 8% (PP) in the CL arm, and 6% (ITT) and 5% (PP) in the IL arm.","[{'ForeName': 'Sara Abdulaziz', 'Initials': 'SA', 'LastName': 'Alfadda', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chvartszaid', 'Affiliation': ''}, {'ForeName': 'Huda Ismail', 'Initials': 'HI', 'LastName': 'Tulbah', 'Affiliation': ''}, {'ForeName': 'Yoav', 'Initials': 'Y', 'LastName': 'Finer', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1314,28231494,Marijuana and other substance use among male and female underage drinkers who drive after drinking and ride with those who drive after drinking.,"The study sought to describe the occurrence of adolescent driving after drinking (DD) and riding with a driver who had been drinking (RWDD) and associations with substance use for both males and females. As part of screening for a randomized controlled trial, we surveyed 16-20year olds (N=3418) recruited from an emergency department (ED) and analyzed data from those reporting past-year alcohol consumption (n=2150, 58% females). DD was reported by 22% of females and 28% of males and RWDD was reported by 39% of females and 38% of males, also in the past year. In regression models, risky alcohol use and past-year marijuana use were associated with increased odds of DD and RWDD for females and males. Marijuana use was a strong predictor, with odds increased by 2.3 and 1.7 times for DD among females and males respectively and 1.4 times for RWDD for females and males. Prescription drug misuse was also associated with RWDD for females and for both males' and females' reported DD. The findings highlight the alarming rate of DD and RWDD among both males and females and suggest ED-based injury prevention efforts consider such risky road behavior as well as consider their substance use. Future research might also further examine the effects of driving under influence of substances, particularly marijuana, and the negative synergistic effects of co-ingestion prior to driving.",2017,"Marijuana use was a strong predictor, with odds increased by 2.3 and 1.7 times for DD among females and males respectively and 1.4 times for RWDD for females and males.","['male and female underage drinkers who drive after drinking and ride with those who drive after drinking', 'surveyed 16-20year olds (N=3418) recruited from an emergency department (ED) and analyzed data from those reporting past-year alcohol consumption (n=2150, 58% females']",['adolescent driving after drinking (DD) and riding with a driver who had been drinking (RWDD'],"['RWDD', 'rate of DD and RWDD', 'DD']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]",[],3418.0,0.0166934,"Marijuana use was a strong predictor, with odds increased by 2.3 and 1.7 times for DD among females and males respectively and 1.4 times for RWDD for females and males.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Buckley', 'Affiliation': 'University of Michigan Transportation Research Institute, Ann Arbor, MI, United States; University of Michigan Injury Center, Ann Arbor, MI, United States. Electronic address: buckleylisad@gmail.com.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'University of Michigan, Department of Psychiatry, Addiction Center, Ann Arbor, MI, United States.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'University of Michigan Injury Center, Ann Arbor, MI, United States; University of Michigan, Department of Psychiatry, Addiction Center, Ann Arbor, MI, United States.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Carter', 'Affiliation': 'University of Michigan Injury Center, Ann Arbor, MI, United States; University of Michigan, Department of Emergency Medicine, Ann Arbor, MI, United States; Michigan Youth Violence Prevention Center, University of Michigan School of Public Health, Ann Arbor, MI, United States.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Voloshyna', 'Affiliation': 'V.N. Karazin Kharkiv National University, Department of Psychiatry, Narcology, Neurology and Medical Psychology, Kharkiv, Ukraine.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Ehrlich', 'Affiliation': ""University of Michigan Injury Center, Ann Arbor, MI, United States; University of Michigan Health System, C.S. Mott Children's Hospital, Department of Surgery, Section of Pediatric Medicine, Ann Arbor, MI, United States.""}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Cunningham', 'Affiliation': 'University of Michigan Injury Center, Ann Arbor, MI, United States; University of Michigan, Department of Emergency Medicine, Ann Arbor, MI, United States; Michigan Youth Violence Prevention Center, University of Michigan School of Public Health, Ann Arbor, MI, United States; Department of Health Behavior Health Education, University of Michigan School of Public Health, Ann Arbor, MI, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2017.02.016']
1315,31221299,Renal Denervation for Treating Hypertension: Current Scientific and Clinical Evidence.,"Initial studies of catheter-based renal denervation (RDN) for uncontrolled HTN using radiofrequency ablation in the main renal arteries showed that RDN was effective in lowering office blood pressure (BP). However, the first randomized sham-controlled trial, SYMPLICITY-HTN-3, did not show significantly lower office or 24-h ambulatory systolic BP compared with sham treatment. Subsequent studies in both animals and humans demonstrated the potential importance of more distal and branch renal artery radiofrequency ablation, and a second-generation multielectrode system became available. Two recent randomized sham-controlled trials in patients not taking antihypertensive drugs (SPYRAL HTN-OFF MED) or continuing to take drugs (SPYRAL HTN-ON MED) performed RDN with the second-generation radiofrequency ablation system using an ablation protocol that included treatment of the distal renal artery as well as the branch renal arteries. These studies showed that RDN significantly reduced office and 24-h ambulatory BP compared with sham treatment. Another recent randomized sham-controlled trial in patients not receiving medications showed that RDN with catheter-based ultrasound (RADIANCE-HTN SOLO) applied in just the main renal arteries significantly lowered daytime ambulatory and office BP compared with sham treatment. These trials have renewed clinical and scientific interest in defining the appropriate role of RDN in hypertension treatment. In addition, other important issues will need to be addressed in the future such as the development of tests to determine the extent of RDN at the time of the procedure and the potential of renal nerve fibers to regain their patency at some later stage following the ablation procedure.",2019,Initial studies of catheter-based renal denervation (RDN) for uncontrolled HTN using radiofrequency ablation in the main renal arteries showed that RDN was effective in lowering office blood pressure (BP).,"['Treating\xa0Hypertension', 'patients not taking antihypertensive drugs (SPYRAL HTN-OFF MED) or continuing to take drugs (SPYRAL HTN-ON MED) performed']","['radiofrequency ablation', 'catheter-based renal denervation (RDN', 'RDN with the second-generation radiofrequency ablation system', 'Renal Denervation']","['daytime ambulatory and office BP', 'RDN significantly reduced office and 24-h ambulatory BP', '24-h ambulatory systolic BP', 'office blood pressure (BP']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",2.0,0.0423083,Initial studies of catheter-based renal denervation (RDN) for uncontrolled HTN using radiofrequency ablation in the main renal arteries showed that RDN was effective in lowering office blood pressure (BP).,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Weber', 'Affiliation': 'Department of Medicine, SUNY Downstate College of Medicine, Brooklyn, New York. Electronic address: michaelwebermd@cs.com.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Saarland, Saarland University, Homburg, Germany.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Schmieder', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital of the Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Department of Interventional Cardiology, Piedmont Heart Institute, Atlanta, Georgia.'}, {'ForeName': 'Konstantinos P', 'Initials': 'KP', 'LastName': 'Tsioufis', 'Affiliation': 'Department of Cardiology, National and Kapodistrian University of Athens, Hippocration Hospital, Athens Medical Center, Athens, Greece.'}, {'ForeName': 'Raymond R', 'Initials': 'RR', 'LastName': 'Townsend', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Department of Cardiovascular Medicine and Department of Sleep and Circadian Cardiology, Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Saarland, Saarland University, Homburg, Germany.'}, {'ForeName': 'Andrew S P', 'Initials': 'ASP', 'LastName': 'Sharp', 'Affiliation': 'Department of Cardiology, Royal Devon and Exeter Hospital, Exeter, United Kingdom.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Osborn', 'Affiliation': 'Department of Physiology, Lillehei Heart Institute, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Greg D', 'Initials': 'GD', 'LastName': 'Fink', 'Affiliation': 'Department of Pharmacology and Toxicology, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Euler', 'Affiliation': 'Medtronic, Minneapolis, Minnesota.'}, {'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Cohen', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Markus P', 'Initials': 'MP', 'LastName': 'Schlaich', 'Affiliation': 'Baker IDI Heart and Diabetes Institute, Melbourne, Australia; Dobney Hypertension Centre, Royal Perth Hospital Campus-University of Western Australia, Perth, Australia.'}, {'ForeName': 'Murray D', 'Initials': 'MD', 'LastName': 'Esler', 'Affiliation': 'Baker IDI Heart and Diabetes Institute, Melbourne, Australia; Dobney Hypertension Centre, Royal Perth Hospital Campus-University of Western Australia, Perth, Australia.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.02.050']
1316,30839430,"Efficacy and safety of loxoprofen sodium topical patch for the treatment of pain in patients with minor acute traumatic limb injuries in Brazil: a randomized, double-blind, noninferiority trial.","Posttraumatic injury pain is commonly treated with oral nonsteroidal anti-inflammatory drugs. However, oral nonsteroidal anti-inflammatory drugs cause several adverse events, with topical formulations arising as an important alternative. Therefore, we aimed at evaluating the efficacy and safety of loxoprofen patch (LX-P) in the treatment of patients with posttraumatic pain. This phase III, randomized, double-blind, noninferiority study enrolled Brazilian patients aged 18 to 65 years diagnosed with lower and upper limb posttraumatic injury who were experiencing moderate or severe pain. Patients were assigned to active LX-P or to loxoprofen tablet (LX-T), and pain intensity was measured based on a visual analog scale score variation after 7 days of treatment. Data on clinical symptoms, rescue medication use, and adverse events were also collected. Visual analog scale score variation was compared using a 10% noninferiority margin. Two hundred forty-two patients were randomly assigned to LX-P (n = 123) or to LX-T (n = 119). The results showed a reduction in pain after 7 days of treatment: -49.96 (n = 118; SE 1.7) in the LX-P and -47.71 (n = 117; SE 1.6) in the LX-T groups (difference of -2.25; 95% CI: -5.97 to 1.47; P = 0.23). On the safety analysis, the LX-T group presented twice as many patients with treatment-emergent adverse events as the LX-P group (30.8% and 14.2%, respectively). A sensitivity analysis demonstrated that rescue medication use has not affected the primary end point. This study showed that LX-P has a comparable efficacy to LX-T, but with a better safety profile, being a therapeutic option for the treatment of posttraumatic injury pain.",2019,The results showed a reduction in pain after 7 days of treatment: -49.96,"['patients with posttraumatic pain', 'enrolled Brazilian patients aged 18 to 65 years diagnosed with lower and upper limb posttraumatic injury who were experiencing moderate or severe pain', 'Two hundred forty-two patients', 'patients with minor acute traumatic limb injuries in Brazil']","['active LX-P or to loxoprofen', 'loxoprofen sodium topical patch', 'LX-T', 'loxoprofen patch (LX-P']","['Visual analog scale score variation', 'Posttraumatic injury pain', 'pain', 'clinical symptoms, rescue medication use, and adverse events', 'Efficacy and safety', 'pain intensity', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0743668', 'cui_str': 'Limb injury'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0065199', 'cui_str': 'loxoprofen'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",242.0,0.275841,The results showed a reduction in pain after 7 days of treatment: -49.96,"[{'ForeName': 'Edison N', 'Initials': 'EN', 'LastName': 'Fujiki', 'Affiliation': 'Faculdade de Medicina do ABC, Department Orthopaedics and Traumatology, Brazil.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Netto', 'Affiliation': 'Universidade Federal de São Paulo, EPFM-UNIFESP, Department of Orthopaedics and Traumatology, Brazil.'}, {'ForeName': 'Durval C', 'Initials': 'DC', 'LastName': 'Kraychete', 'Affiliation': 'Universidade Federal da Bahia, UFBA, Department of Anesthesiology and Surgery, Brazil.'}, {'ForeName': 'Murilo T', 'Initials': 'MT', 'LastName': 'Daher', 'Affiliation': 'Universidade Federal de Goiás, UFG, Department of Orthopaedics and Traumatology, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Tardini', 'Affiliation': 'Hospital e MAternidade Cristóvão da Gama.'}, {'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Nakamoto', 'Affiliation': 'Daiichi Sankyo Brasil, Clinical Research Department, São Paulo, Brazil.'}, {'ForeName': 'Danilo G', 'Initials': 'DG', 'LastName': 'Lopes', 'Affiliation': 'Daiichi Sankyo Brasil, Clinical Research Department, São Paulo, Brazil.'}]",Pain,['10.1097/j.pain.0000000000001549']
1317,31551368,Potent reduction of plasma lipoprotein (a) with an antisense oligonucleotide in human subjects does not affect ex vivo fibrinolysis.,"It is postulated that lipoprotein (a) [Lp(a)] inhibits fibrinolysis, but this hypothesis has not been tested in humans due to the lack of specific Lp(a) lowering agents. Patients with elevated Lp(a) were randomized to antisense oligonucleotide [IONIS-APO(a) Rx ] directed to apo(a) ( n  = 7) or placebo ( n  = 10). Ex vivo plasma lysis times and antigen concentrations of plasminogen, factor XI, plasminogen activator inhibitor 1, thrombin activatable fibrinolysis inhibitor, and fibrinogen at baseline, day 85/92/99 (peak drug effect), and day 190 (3 months off drug) were measured. The mean ± SD baseline Lp(a) levels were 477.3 ± 55.9 nmol/l in IONIS-APO(a) Rx  and 362.1 ± 89.9 nmol/l in placebo. The mean± SD percentage change in Lp(a) for IONIS-APO(a) Rx  was -69.3 ± 12.2% versus -5.4 ± 6.9% placebo ( P  < 0.0010) at day 85/92/99 and -15.6 ± 8.9% versus 3.2 ± 12.2% ( P  = 0.003) at day 190. Clot lysis times and coagulation/fibrinolysis-related biomarkers showed no significant differences between IONIS-APO(a) Rx  and placebo at all time points. Clot lysis times were not affected by exogenously added Lp(a) at concentrations up to 200 nmol/l to plasma with very low (12.5 nmol/l) Lp(a) levels, whereas recombinant apo(a) had a potent antifibrinolytic effect. In conclusion, potent reductions of Lp(a) in patients with highly elevated Lp(a) levels do not affect ex vivo measures of fibrinolysis; the relevance of any putative antifibrinolytic effects of Lp(a) in vivo needs further study.",2019,Clot lysis times and coagulation/fibrinolysis-related biomarkers showed no significant differences between IONIS-APO(a)Rx and placebo at all timepoints.,"['patients with highly elevated Lp(a) levels', 'lipoprotein(a) [Lp(a', 'Patients with elevated Lp(a', 'human subjects']","['placebo', 'Lp(a', 'antisense oligonucleotide (IONIS-APO(a)Rx) directed to apolipoprotein(a']","['Clot lysis times and coagulation/fibrinolysis-related biomarkers', 'Lp(a', 'mean (SD) percent change in Lp(a', 'Clot lysis times', 'plasma lipoprotein(a', 'Ex vivo plasma lysis times and antigen concentrations of plasminogen, factor XI, PAI-1, TAFI, and fibrinogen', 'mean (SD) baseline Lp(a) levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079925', 'cui_str': 'Anti-Sense Oligonucleotides'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0200464', 'cui_str': 'Clot Lysis Time'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0024348', 'cui_str': 'Lysis (morphologic abnormality)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032140', 'cui_str': 'Profibrinolysin'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",200.0,0.129998,Clot lysis times and coagulation/fibrinolysis-related biomarkers showed no significant differences between IONIS-APO(a)Rx and placebo at all timepoints.,"[{'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Boffa', 'Affiliation': 'Department of Biochemistry Schulich School of Medicine & Dentistry, The University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Tanya T', 'Initials': 'TT', 'LastName': 'Marar', 'Affiliation': 'Department of Biochemistry Schulich School of Medicine & Dentistry, The University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Yeang', 'Affiliation': 'Division of Endocrinology and Metabolism, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Viney', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Witztum', 'Affiliation': 'Division of Endocrinology and Metabolism, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Marlys L', 'Initials': 'ML', 'LastName': 'Koschinsky', 'Affiliation': 'Robarts Research Institute, Schulich School of Medicine & Dentistry, The University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'Division of Endocrinology and Metabolism, University of California San Diego, La Jolla, CA stsimikas@ucsd.edu.'}]",Journal of lipid research,['10.1194/jlr.P094763']
1318,31210105,Diabetic Hemodialysis: Vitamin D Supplementation and its Related Signaling Pathways Involved in Insulin and Lipid Metabolism.,"BACKGROUND


This study was conducted to determine the effects of vitamin D supplementation on some of the gene expressions related to insulin and lipid metabolism in diabetic hemodialysis (HD) patients.
METHODS


A double-blind, randomized, placebo-controlled clinical trial was carried out in 55 patients with diabetic HD. The current project used two groups in which each subject received vitamin D supplements (50,000 IU, n=28) or placebo (50,000 IU, n=27) every 2 weeks for 12 weeks. Gene expression analyses (RT-PCR) were included to obtain the rate of gene expression of the related insulin and lipid metabolism genes in peripheral blood mononuclear cells (PBMCs) of patients with diabetic HD.
RESULTS


Our data revealed that consumption of vitamin D supplementation enables to overexpress the peroxisome proliferation-activated receptor gamma (PPAR-γ) (P=0.001), AKT (P=0.04), PI3K (P=0.02), insulin receptor substrate-1 (IRS1) (P0.008) and glucose transporter type 4 (GLUT-4) (P=0.01) and downregulate the expression of protein kinase C (PKC) (P=0.001) in patients with diabetic HD than control group following the 12-week intervention. In addition, vitamin D supplementation downregulated low-density lipoprotein receptor (LDLR) (P=0.03) expression in the subjects with diabetic HD than the control group. Vitamin D supplementation did not show any effects on the expression of pyruvate dehydrogenase kinase 1 (PDK1) (P=0.37), IRS2 (P=0.90) and lipoprotein (a) [Lp(a)] (P=0.05).
CONCLUSION


Our findings confirmed that diabetic HD subjects who received the vitamin D supplementation (for 12 weeks), showed a significant overexpression in the PPAR-γ, AKT, PI3K, IRS1 and GLUT4 genes, and also showed a significant downregulation in the PKC and LDLR genes. Moreover, no effects on PDK1, IRS2 and Lp(a) expression were observed.",2019,"In addition, vitamin D supplementation down regulated low density lipoprotein receptor (LDLR) (P=0.03) expression in the subjects with diabetic HD than the control group.","['Diabetic hemodialysis', 'diabetic HD subjects', '55 patients with diabetic HD']","['vitamin D supplements', 'Vitamin D supplementation', 'vitamin D supplementation', 'placebo']","['peroxisome proliferation-activated receptor gamma (PPAR-γ', 'IRS2 (P=0.90) and lipoprotein (a) [Lp(a', 'PDK1, IRS2 and Lp(a) expression', 'glucose transporter type 4 (GLUT-4) (P=0.01) and down regulate expression of protein kinase C (PKC', 'low density lipoprotein receptor (LDLR', 'insulin receptor substrate-1', 'expression of pyruvate dehydrogenase kinase 1 (PDK1']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0752063'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0166418', 'cui_str': 'Peroxisome Proliferator-Activated Receptors'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0166441', 'cui_str': 'Glucose Transporter Type 4'}, {'cui': 'C0256371', 'cui_str': 'PKC-alpha Serine-Threonine Kinase'}, {'cui': 'C0256015', 'cui_str': 'PRKCG'}, {'cui': 'C0034821', 'cui_str': 'Lipoprotein LDL Receptors'}, {'cui': 'C0123658', 'cui_str': 'Insulin Receptor Substrate-1'}, {'cui': 'C0043655', 'cui_str': 'PDH kinase'}]",55.0,0.150215,"In addition, vitamin D supplementation down regulated low density lipoprotein receptor (LDLR) (P=0.03) expression in the subjects with diabetic HD than the control group.","[{'ForeName': 'Elahe S', 'Initials': 'ES', 'LastName': 'Hosseini', 'Affiliation': 'Anatomical Sciences Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamed H', 'Initials': 'HH', 'LastName': 'Kashani', 'Affiliation': 'Anatomical Sciences Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Nikzad', 'Affiliation': 'Anatomical Sciences Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Soleimani', 'Affiliation': 'Department of Internal Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mirzaei', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mohammd R', 'Initials': 'MR', 'LastName': 'Tamadon', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}]",Current molecular medicine,['10.2174/1566524019666190618144712']
1319,30998965,Video strategies improved health professional knowledge across different contexts: a helix counterbalanced randomized controlled study.,"OBJECTIVE


This study aimed to apply a novel helix counterbalanced randomized controlled trial design to evaluate the effectiveness of video vs. written knowledge translation strategies for improving health professional knowledge of evidence provided in scientific journal articles.
STUDY DESIGN AND SETTING


A Helix counterbalanced randomized controlled trial was used to compare the impact of delivering research information via video or written modalities compared to a no-information control across three health contexts. Interventions were delivered and data collected via an online survey to nursing and allied health professionals across five hospitals within a public health service in Melbourne, Australia. A knowledge test measuring alignment between respondent perceived benefit of the intervention and conclusions listed in the journal article was the primary outcome.
RESULTS


There were 119 participants recruited with n = 13 incomplete responses. Exposure to the video increased the likelihood of a knowledge test response that was aligned with the research evidence compared to the no-information control (OR 2.61; 95% CI 1.40, 4.89; P = 0.003), but this was not the case for exposure to the written modality (OR 1.39; 95% CI 0.75, 2.57; P = 0.294).
CONCLUSION


Providing video knowledge translation strategies to nursing and allied health professionals increases the likelihood they will understand the main findings from scientific journal articles.",2019,"Exposure to the video increased the likelihood of a knowledge test response that was aligned with the research evidence compared to the no-information control (OR 2.61; 95% CI 1.40, 4.89; P = 0.003), but this was not the case for exposure to the written modality (OR 1.39; 95% CI 0.75, 2.57; P = 0.294).
",['119 participants recruited with n\xa0=\xa013 incomplete responses'],['video vs. written knowledge translation strategies'],['health professional knowledge'],"[{'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C3494164', 'cui_str': 'Knowledge Translation'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",119.0,0.218993,"Exposure to the video increased the likelihood of a knowledge test response that was aligned with the research evidence compared to the no-information control (OR 2.61; 95% CI 1.40, 4.89; P = 0.003), but this was not the case for exposure to the written modality (OR 1.39; 95% CI 0.75, 2.57; P = 0.294).
","[{'ForeName': 'Mitchell N', 'Initials': 'MN', 'LastName': 'Sarkies', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Science, Monash University Peninsula Campus, McMahons Road, Frankston, 3199 Victoria, Australia; Allied Health Research Unit, Monash Health Kingston Centre, 400 Warrigal Road, Cheltenham, 3092 Victoria, Australia. Electronic address: mitchell.sarkies@monash.edu.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Maloney', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Science, Monash University Peninsula Campus, McMahons Road, Frankston, 3199 Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Symmons', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Haines', 'Affiliation': 'School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University Peninsula Campus, McMahons Road, Frankston, 3199 Victoria, Australia.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.04.003']
1320,31622158,Effect of β-alanine supplementation during high-intensity interval training on repeated sprint ability performance and neuromuscular fatigue.,"The study investigated the influence of β-alanine supplementation during a high-intensity interval training (HIIT) program on repeated sprint ability (RSA) performance. This study was randomized, double-blinded, and placebo controlled. Eighteen men performed an incremental running test until exhaustion (T INC ) at baseline and followed by 4-wk HIIT (10 × 1-min runs 90% maximal T INC  velocity [1-min recovery]). Then, participants were randomized into two groups and performed a 6-wk HIIT associated with supplementation of 6.4 g/day of β-alanine (Gβ) or dextrose (placebo group; GP). Pre- and post-6-wk HIIT + supplementation, participants performed the following tests:  1 ) T INC ;  2 ) supramaximal running test; and  3 ) 2 × 6 × 35-m sprints (RSA). Before and immediately after RSA, neuromuscular function was assessed by vertical jumps, maximal isometric voluntary contractions of knee extension, and neuromuscular electrical stimulations. Muscle biopsies were performed to determine muscle carnosine content, muscle buffering capacity in vitro (βm in vitro ), and content of phosphofructokinase (PFK), monocarboxylate transporter 4 (MCT4), and hypoxia-inducible factor-1α (HIF-1α). Both groups showed a significant time effect for maximal oxygen uptake (Gβ: 6.2 ± 3.6% and GP: 6.5 ± 4.2%;  P  > 0.01); only Gβ showed a time effect for total (-3.0 ± 2.0%;  P  = 0.001) and best (-3.3 ± 3.0%;  P  = 0.03) RSA times. A group-by-time interaction was shown after HIIT + Supplementation for muscle carnosine (Gβ: 34.4 ± 2.3 mmol·kg -1 ·dm -1  and GP: 20.7 ± 3.0 mmol·kg -1 ·dm -1 ;  P  = 0.003) and neuromuscular voluntary activation after RSA (Gβ: 87.2 ± 3.3% and GP: 78.9 ± 12.4%;  P  = 0.02). No time effect or group-by-time interaction was shown for supramaximal running test performance, βm, and content of PFK, MCT4, and HIF-1α. In summary, β-alanine supplementation during HIIT increased muscle carnosine and attenuated neuromuscular fatigue, which may contribute to an enhancement of RSA performance. NEW & NOTEWORTHY  β-Alanine supplementation during a high-intensity interval training program increased repeated sprint performance. The improvement of muscle carnosine content induced by β-alanine supplementation may have contributed to an attenuation of central fatigue during repeated sprint. Overall, β-alanine supplementation may be a useful dietary intervention to prevent fatigue.",2019,"No time effect or group-by-time interaction were shown for supramaximal running test performance, βm invitro  and content of PFK,",['Eighteen men'],"['β-alanine supplementation', 'β-Alanine supplementation during a high-intensity interval training (HIIT) program', 'MCT4 and HIF-1α', 'HIIT+Supplementation for muscle carnosine (Gβ', 'placebo', '6-week HIIT associated with supplementation of 6.4g·day -1  of β-Alanine (Gβ) or dextrose (Placebo group; GP']","['neuromuscular voluntary activation', 'neuromuscular function', 'neuromuscular fatigue', 'supramaximal running test performance, βm invitro  and content of PFK', 'repeated sprint ability (RSA) performance', 'vertical jumps, maximal isometric voluntary contractions of knee extension and neuromuscular electrical stimulations', 'muscle carnosine content, muscle buffer capacity  in vitro  ( βm invitro ) and content of phosphofructokinase (PFK), monocarboxylate transporter 4 (MCT4) and hypoxia-inducible factor-1α (HIF-1α', 'repeated sprint ability performance and neuromuscular fatigue', 'time-effect for maximal oxygen uptake']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0007267', 'cui_str': 'Carnosine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue, function (observable entity)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0007267', 'cui_str': 'Carnosine'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0031651', 'cui_str': '6-Phosphofructokinase'}, {'cui': 'C2316841', 'cui_str': 'Monocarboxylate'}, {'cui': 'C3854146', 'cui_str': 'Transporter (physical object)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}]",,0.276849,"No time effect or group-by-time interaction were shown for supramaximal running test performance, βm invitro  and content of PFK,","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Milioni', 'Affiliation': 'Post Graduate Program in Human Movement Sciences, Laboratory of Physiology and Human Performance, São Paulo State University, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo Araújo Bonetti', 'Initials': 'RAB', 'LastName': 'de Poli', 'Affiliation': 'Post Graduate Program in Human Movement Sciences, Laboratory of Physiology and Human Performance, São Paulo State University, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Applied Physiology and Nutrition Research Group, Faculdade de Medicina da Universidade de São Paul, Rheumatology Division, School of Physical Education and Sport, University of São Paulo, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology and Nutrition Research Group, Faculdade de Medicina da Universidade de São Paul, Rheumatology Division, School of Physical Education and Sport, University of São Paulo, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alisson L', 'Initials': 'AL', 'LastName': 'da Rocha', 'Affiliation': 'School of Physical Education and Sports of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Adelino', 'Initials': 'A', 'LastName': 'Sanchez Ramos da Silva', 'Affiliation': 'School of Physical Education and Sports of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Paulo de Tarso Guerrero', 'Initials': 'PTG', 'LastName': 'Muller', 'Affiliation': 'Laboratory of Respiratory Pathophysiology, Mato Grosso do Sul Federal University, Campo Grande, Mato Grosso do Sul, São Paulo, Brazil.'}, {'ForeName': 'Alessandro Moura', 'Initials': 'AM', 'LastName': 'Zagatto', 'Affiliation': 'Post Graduate Program in Human Movement Sciences, Laboratory of Physiology and Human Performance, São Paulo State University, Bauru, São Paulo, Brazil.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00321.2019']
1321,31209560,Oral vitamin A supplementation in very low birth weight neonates: a randomized controlled trial.,"This randomized double-blind placebo-controlled trial evaluated the effects of early postnatal oral vitamin A supplementation (VAS) in 196 inborn very-low birth weight (VLBW) infants requiring respiratory support at 24 h of age. Eligible infants were randomized to receive aqueous syrup of vitamin A (10,000 IU of retinol/dose; n = 98) or placebo (n = 98) on alternate days for 28 days. Primary outcome variable was composite incidence of all-cause mortality and/or oxygen requirement for 28 days. Secondary outcome variables were safety/tolerability of VAS, serum retinol concentration at recruitment and day 28, duration of oxygen requirement and respiratory support and incidences of complications. On intention-to-treat analysis, composite incidence of all-cause mortality and oxygen requirement for 28 days was significantly lower in vitamin A group (relative risk (95% confidence interval), 0.440 (0.229-0.844); p < 0.05, number needed to benefit, 7). Requirement and duration of oxygen supplementation and non-invasive respiratory support, incidences of late-onset sepsis, patent ductus arteriosus, and duration of hospital stay were also significantly lower in vitamin A group. Serum retinol concentration improved significantly after VAS. No major adverse effect was observed.Conclusions: Early postnatal oral VAS was associated with better composite outcome of all-cause mortality and oxygen requirement without any major adverse effects.Clinical Trial Registration: Clinical Trials Registry of India (CTRI/2017/03/008131). What is Known: • Postnatal intramuscular vitamin A supplementation improves the survival, respiratory outcome and other morbidities in very low birth weight neonates without major adverse effects. • Limited studies on oral vitamin A supplementation did not document substantial benefits. What is New: • Early postnatal alternate-day oral vitamin A supplementation at the dose of 10,000 IU/dose for 28 days improves the composite outcome of death and oxygen requirement in very low birth weight neonates with respiratory distress • No major adverse effects were documented.",2019,No major adverse effects were documented.,"['very low birth weight neonates with respiratory distress •', 'very low birth weight neonates', '196 inborn very-low birth weight (VLBW) infants requiring respiratory support at 24\xa0h of age', 'Eligible infants']","['placebo', 'aqueous syrup of vitamin A (10,000\xa0IU of retinol/dose; n\u2009=\u200998) or placebo', 'vitamin A supplementation', 'Oral vitamin A supplementation', 'early postnatal oral vitamin A supplementation (VAS', 'oral vitamin']","['Requirement and duration of oxygen supplementation and non-invasive respiratory support, incidences of late-onset sepsis, patent ductus arteriosus, and duration of hospital stay', 'composite outcome of death and oxygen requirement', 'Serum retinol concentration', 'survival, respiratory outcome and other morbidities', 'composite incidence of all-cause mortality and/or oxygen requirement for 28\xa0days', 'safety/tolerability of VAS, serum retinol concentration at recruitment and day 28, duration of oxygen requirement and respiratory support and incidences of complications']","[{'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0458173', 'cui_str': 'Syrup (substance)'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.696425,No major adverse effects were documented.,"[{'ForeName': 'Sriparna', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India. drsriparnabasu@rediffmail.com.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Khanna', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'Ragini', 'Initials': 'R', 'LastName': 'Srivastava', 'Affiliation': 'Department of Biochemistry, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}]",European journal of pediatrics,['10.1007/s00431-019-03412-w']
1322,31793863,Can negative ureteroscopy be predicted in ureteral stone treatment?,"INTRODUCTION


We aimed to evaluate factors predictive of negative ureteroscopy (URS) in ureteral stones.
METHODS


Patients who underwent URS between January 2007 and June 2018 were included in the study. Patients were divided into two groups: group 1- positive URS (841 patients); and group 2 -negative URS (75 patients). These two groups were compared in terms of demographic data, stone characteristics, and postoperative outcomes.
RESULTS


The mean age of the study patients was 44.5±15.1 years. The absence of collecting system dilatation due to the present stone was found to be a significant predictive factor for negative URS in univariate analysis, but there was no significant difference in multivariate analysis. In the multivariate analysis, low body mass index (BMI), no history of stone surgery, stone located in the distal ureter, small stone area, longer time between the last imaging procedure and URS, and medical expulsive therapy (MET) application were statistically significant in predicting negative URS.
CONCLUSIONS


In this study, the parameters that significantly predicted negative URS were found to be low BMI, no history of stone surgery, distal localization of the stone, small stone area, longer time between the last imaging procedure and URS, and MET applied for the current stone. These parameters should be considered to avoid negative URS and patients should be informed of the possibility of negative URS prior to operation.",2020,"The absence of collecting system dilatation due to the present stone was found to be a significant predictive factor for negative URS in univariate analysis, but there was no significant difference in multivariate analysis.",['Patients who underwent URS between January 2007 and June 2018 were included in the study'],"['positive URS (841 patients) and group 2: negative URS', 'negative ureteroscopy (URS']","['low body mass index (BMI), no history of stone surgery, stone located in the distal ureter, small stone area', 'demographic data, stone characteristics, and postoperative outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}]","[{'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0041951', 'cui_str': 'Ureter'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",841.0,0.0147003,"The absence of collecting system dilatation due to the present stone was found to be a significant predictive factor for negative URS in univariate analysis, but there was no significant difference in multivariate analysis.","[{'ForeName': 'Mehmet Oguz', 'Initials': 'MO', 'LastName': 'Sahin', 'Affiliation': 'Manisa State Hospital, Department of Urology, Manisa, Turkey.'}, {'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Sen', 'Affiliation': 'Manisa State Hospital, Department of Urology, Manisa, Turkey.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Irer', 'Affiliation': 'Izmir Metropolitan Municipality Esrefpasa Hospital, Department of Urology, Izmir, Turkey.'}, {'ForeName': 'Guner', 'Initials': 'G', 'LastName': 'Yildiz', 'Affiliation': 'Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, Department of Urology, Izmir, Turkey.'}]",Canadian Urological Association journal = Journal de l'Association des urologues du Canada,['10.5489/cuaj.6026']
1323,30101278,Influence of intravenous fentanyl compared with morphine on ticagrelor absorption and platelet inhibition in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: rationale and design of the PERSEUS randomized trial.,"AIMS


Recent evidence demonstrates that intravenous morphine significantly reduces absorption and delays onset of action of oral P2Y12 receptor inhibitors in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI). We aimed to assess the influence of intravenous fentanyl compared with morphine on pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite (AR-C124910XX) in patients undergoing pPCI for STEMI.
METHODS AND RESULTS


Single-centre, prospective, open-label, randomized controlled study that will randomly assign in a 1:1 ratio patients with STEMI undergoing pPCI to receive intravenous fentanyl or morphine following a pre-hospital 180-mg loading dose of ticagrelor (ClinicalTrials.gov Identifier: NCT02531165). Pharmacokinetic and pharmacodynamic analyses will be performed at baseline and 1, 2, 4, 6, and 12 h post-loading dose. Pharmacodynamic assessments will include P2Y12 reaction units (PRU) measured by VerifyNow P2Y12. Pharmacokinetic assessments include determination of maximal observed plasma concentrations, time for maximal plasma concentration, and area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) for ticagrelor and AR-C124910XX. The primary endpoint is platelet reactivity assessed by PRU at 2 h post ticagrelor loading dose.
CONCLUSION


PERSEUS will provide randomized data regarding the impact of fentanyl administration, in patients with STEMI undergoing pPCI, on platelet inhibition and ticagrelor absorption and total exposure.",2019,"AIMS


Recent evidence demonstrates that intravenous morphine significantly reduces absorption and delays onset of action of oral P2Y12 receptor inhibitors in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI).","['patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention', 'patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI', 'patients undergoing pPCI for STEMI', '1:1 ratio patients with STEMI undergoing pPCI to receive', 'patients with STEMI undergoing pPCI, on platelet inhibition and ticagrelor absorption and total exposure']","['ticagrelor and its active metabolite (AR-C124910XX', 'fentanyl', 'morphine', 'ticagrelor', 'intravenous fentanyl or morphine']","['ticagrelor absorption and platelet inhibition', 'platelet reactivity assessed by PRU at 2\u2009h post ticagrelor loading dose', 'Pharmacokinetic assessments include determination of maximal observed plasma concentrations, time for maximal plasma concentration, and area under the plasma concentration vs. time curve']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C3254492', 'cui_str': 'AR C124910XX'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.116564,"AIMS


Recent evidence demonstrates that intravenous morphine significantly reduces absorption and delays onset of action of oral P2Y12 receptor inhibitors in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI).","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Degrauwe', 'Affiliation': 'Department of Cardiology, Geneva University Hospital, Rue Gabrielle-Perret-Gentil 4, Geneva, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Roffi', 'Affiliation': 'Department of Cardiology, Geneva University Hospital, Rue Gabrielle-Perret-Gentil 4, Geneva, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Lauriers', 'Affiliation': 'Department of Cardiology, Lausanne University Hospital, Rue du Bugnon 46, Lausanne, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Muller', 'Affiliation': 'Department of Cardiology, Lausanne University Hospital, Rue du Bugnon 46, Lausanne, Switzerland.'}, {'ForeName': 'Pier Giorgio', 'Initials': 'PG', 'LastName': 'Masci', 'Affiliation': 'Department of Cardiology, Lausanne University Hospital, Rue du Bugnon 46, Lausanne, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Freiburgstrasse 4, Bern, Switzerland.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Iglesias', 'Affiliation': 'Department of Cardiology, Geneva University Hospital, Rue Gabrielle-Perret-Gentil 4, Geneva, Switzerland.'}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvy031']
1324,31215985,Comparison of Outcomes After Transcatheter vs Surgical Aortic Valve Replacement Among Patients at Intermediate Operative Risk With a History of Coronary Artery Bypass Graft Surgery: A Post Hoc Analysis of the SURTAVI Randomized Clinical Trial.,"Importance


Surgical aortic valve replacement (SAVR) has increased risk for patients with aortic stenosis (AS) and a history of coronary artery bypass graft (CABG) surgery. Transcatheter aortic valve replacement (TAVR) may be an alternative.
Objective


To compare TAVR with SAVR outcomes in patients at intermediate operative risk with prior CABG surgery.
Design, Setting, and Participants


In this post hoc analysis of the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) noninferiority randomized clinical trial, patients with severe, symptomatic AS at intermediate operative risk were enrolled from 87 centers across the United States, Europe, and Canada from June 2012 to June 2016 and followed-up with up to July 2017. Those with a history of CABG surgery were considered for analysis. Data were analyzed from September to December 2017.
Interventions


A total of 1746 patients were enrolled and randomized 1:1 to self-expanding TAVR or SAVR. An implant was attempted in 1660 patients, of whom 273 had prior CABG surgery, including 136 who underwent attempted TAVR and 137 who underwent attempted SAVR.
Main Outcomes and Measures


The primary outcome was all-cause mortality or disabling stroke at 1-year follow-up. Efficacy outcomes included quality of life, measured using the Kansas City Cardiomyopathy Questionnaire at 30 days, 6 months, and 1 year, and distance walked in 6 minutes, measured using the 6-minute walk test at 30 days and 1 year.
Results


Of the 136 patients in the TAVR cohort, 111 (81.6%) were male, and the mean (SD) age was 76.9 (6.5) years; of the 137 in the SAVR cohort, 117 (85.4%) were male, and the mean (SD) age was 76.6 (6.5) years. The mean (SD) Society of Thoracic Surgeons Predicted Risk of Mortality score was 5.0% (1.6%) in the TAVR cohort and 5.2% (1.7%) in the SAVR cohort. All-cause mortality or disabling stroke at 1-year follow-up was 8.9% (95% CI, 5.2-15.2) in the TAVR cohort and 6.7% (95% CI, 3.5-12.8) in the SAVR cohort (log-rank P = .53). Compared with patients receiving SAVR, the mean (SD) Kansas City Cardiomyopathy Questionnaire summary score was significantly better among patients receiving TAVR at 30 days (81.4 [19.2] vs 69.7 [22.6]; P < .001); treatments were similar at 1 year (85.7 [14.6] vs 82.8 [18.4]; P = .19). Compared with patients in the SAVR cohort, those in the TAVR cohort showed greater mean (SD) improvement in distance walked at 1 year (48.3 [120.6] m vs 16.8 [88.7] m; P = .04).
Conclusions and Relevance


Both TAVR and SAVR were safe for intermediate-risk patients with AS and prior CABG surgery. The transcatheter approach facilitated faster improvement in quality of life and better exercise capacity at 1-year follow-up.
Trial Registration


ClinicalTrials.gov identifier: NCT01586910.",2019,"The transcatheter approach facilitated faster improvement in quality of life and better exercise capacity at 1-year follow-up.
","['1660 patients, of whom 273 had prior CABG surgery, including 136 who underwent attempted TAVR and 137 who underwent attempted SAVR', 'Patients at Intermediate Operative Risk With a History of Coronary Artery Bypass Graft Surgery', 'patients at intermediate operative risk with prior CABG surgery', 'A total of 1746 patients', '136 patients in the TAVR cohort, 111 (81.6%) were male, and the mean (SD) age was 76.9 (6.5) years; of the 137 in the SAVR cohort, 117 (85.4%) were male, and the mean (SD) age was 76.6 (6.5) years', 'patients with aortic stenosis (AS) and a history of coronary artery bypass graft (CABG) surgery', 'patients with severe, symptomatic AS at intermediate operative risk were enrolled from 87 centers across the United States, Europe, and Canada from June 2012 to June 2016 and followed-up with up to July 2017']","['Transcatheter vs Surgical Aortic Valve Replacement', 'Transcatheter aortic valve replacement (TAVR', 'Surgical Replacement and Transcatheter Aortic Valve Implantation', 'Surgical aortic valve replacement (SAVR', 'self-expanding TAVR or SAVR', 'TAVR and SAVR']","['quality of life and better exercise capacity', 'mean (SD) Society of Thoracic Surgeons Predicted Risk of Mortality score', 'mean (SD) improvement in distance walked', 'cause mortality or disabling stroke', 'mean (SD) Kansas City Cardiomyopathy Questionnaire summary score', 'quality of life, measured using the Kansas City Cardiomyopathy Questionnaire at 30 days, 6 months, and 1 year, and distance walked in 6 minutes, measured using the 6-minute walk test at 30 days and 1 year', 'mortality or disabling stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0278626', 'cui_str': 'Thoracic surgeon (occupation)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}]",1746.0,0.172768,"The transcatheter approach facilitated faster improvement in quality of life and better exercise capacity at 1-year follow-up.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.'}, {'ForeName': 'Robin H', 'Initials': 'RH', 'LastName': 'Heijmen', 'Affiliation': 'St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Mathew R', 'Initials': 'MR', 'LastName': 'Williams', 'Affiliation': 'NYU Langone Medical Center, New York, New York.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Yakubov', 'Affiliation': 'OhioHeath Riverside Methodist Hospital, Columbus, Ohio.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Watson', 'Affiliation': 'OhioHeath Riverside Methodist Hospital, Columbus, Ohio.'}, {'ForeName': 'Neal S', 'Initials': 'NS', 'LastName': 'Kleiman', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Conte', 'Affiliation': 'The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Chawla', 'Affiliation': 'Iowa Heart Center, Des Moines.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hockmuth', 'Affiliation': 'Iowa Heart Center, Des Moines.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Petrossian', 'Affiliation': 'St Francis Hospital, Roslyn, New York.'}, {'ForeName': 'Newell', 'Initials': 'N', 'LastName': 'Robinson', 'Affiliation': 'St Francis Hospital, Roslyn, New York.'}, {'ForeName': 'A Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Medtronic, Minneapolis, Minnesota.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Medtronic, Minneapolis, Minnesota.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}]",JAMA cardiology,['10.1001/jamacardio.2019.1856']
1325,30975478,"Posterior Hip Precautions Do Not Impact Early Recovery in Total Hip Arthroplasty: A Multicenter, Randomized, Controlled Study.","BACKGROUND


Posterior hip precautions have been routinely prescribed to decrease dislocation rates. The purpose of this study was to determine whether the absence of hip precautions improved early recovery after total hip arthroplasty via the posterolateral approach.
METHODS


Patients undergoing total hip arthroplasty via the posterolateral approach at 3 centers were enrolled. Patients meeting the selection criteria were randomized to standard hip precautions (SHP) or no hip precautions (NHP) for 6 weeks following surgery. HOOS Jr, Health State visual analog score, and rate of pain scores were recorded preoperatively and in subsequent postoperative visits; dislocation episodes were also noted. Standard statistical analysis was performed.
RESULTS


From 2016 to 2017, 159 patients were randomized to SHP and 154 patients were randomized to NHP. Controlling for the center at which the surgery was performed, the only difference in outcome scores between the 2 groups was at 2 weeks; the NHP group had a lower HOOS Jr score when compared to the SHP group (P = .03). There was no difference in outcome scores at any other time points when compared to preoperative assessments. In the SHP group, there were 2 recorded dislocations (1.3%) and 1 in the NHP group (0.7%; P = .62).
CONCLUSION


In this multicenter, randomized, controlled study, the absence of hip precautions in the postoperative period did not improve subjective outcomes which may be explained by the self-limiting behavior of NHP patients. Furthermore, with the numbers available for the study, there was no difference in the rate of dislocation between the 2 groups.",2019,There was no difference in outcome scores at any other time points when compared to preoperative assessments.,"['Patients meeting the selection criteria', 'Total Hip Arthroplasty', 'Patients undergoing total hip arthroplasty via the posterolateral approach at 3 centers were enrolled', 'From 2016 to 2017, 159 patients were randomized to SHP and 154 patients']","['NHP', 'standard hip precautions (SHP) or no hip precautions (NHP']","['HOOS Jr score', 'dislocation rates', 'rate of dislocation', 'HOOS Jr, Health State visual analog score, and rate of pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",159.0,0.0786813,There was no difference in outcome scores at any other time points when compared to preoperative assessments.,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Dietz', 'Affiliation': 'Department of Orthopaedics, Health Sciences Center, WVU School of Medicine, Morgantown, WV.'}, {'ForeName': 'Adam E', 'Initials': 'AE', 'LastName': 'Klein', 'Affiliation': 'Department of Orthopaedics, Health Sciences Center, WVU School of Medicine, Morgantown, WV.'}, {'ForeName': 'Brock A', 'Initials': 'BA', 'LastName': 'Lindsey', 'Affiliation': 'Department of Orthopaedics, Health Sciences Center, WVU School of Medicine, Morgantown, WV.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Duncan', 'Affiliation': 'Department of Orthopaedics, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Eicher', 'Affiliation': 'Department of Orthopaedics, Health Sciences Center, WVU School of Medicine, Morgantown, WV.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Gillig', 'Affiliation': 'Andrews Institute for Orthopaedics and Sports Medicine, Gulf Breeze, FL.'}, {'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Smith', 'Affiliation': 'Andrews Institute for Orthopaedics and Sports Medicine, Gulf Breeze, FL.'}, {'ForeName': 'G Daxton', 'Initials': 'GD', 'LastName': 'Steele', 'Affiliation': 'Andrews Institute for Orthopaedics and Sports Medicine, Gulf Breeze, FL.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.02.057']
1326,31155415,Safety and immunogenicity of a replication-deficient H5N1 influenza virus vaccine lacking NS1.,"BACKGROUND


Traditional inactivated influenza vaccines are the type of vaccines that were most frequently developed for immunization against the highly pathogenic avian H5N1 influenza virus. However, clinical trials with inactivated influenza vaccines for H5N1 indicated that high doses and at least two immunizations are required for an effective immune response (Nicholson et al., 2001; Treanor, Campbell et al., 2006; Treanor, Schiff et al., 2006; Ehrlich et al., 2008). We investigated the safety and immunogenicity of a live attenuated H5N1 vaccine (delNS1-H5N1) lacking the interferon antagonist nonstructural protein 1 (NS1).
METHODS


We conducted a double-blind, placebo-controlled, phase 1 study in healthy adult participants who were randomly assigned at a 2:1 ratio to receive two immunizations of delNS1-H5N1 vaccine at 6.8 log10 50% tissue culture infectious doses (TCID 50 )/subject or 7.5 log10 TCID 50 /subject, or placebo.
RESULTS


Intranasal vaccination with the live attenuated delNS1-H5N1 vaccine was safe and well tolerated. The most common adverse events identified were symptoms associated with mild influenza infections, such as increased body temperature (>37.0 °C), pharyngeal erythema, rhinitis and throat irritation, and were reported within 7 days after the first immunization. delNS1-H5N1 was able to induce significant vaccine-specific serum antibody titers even at the lower dose level of 6.8 log10 TCID 50 /subject. Seroconversion occurred in 75% of study participants after only one immunization with 7.5 log10 TCID 50 /subject. Vaccine-specific local IgA responses were observed in 41.7% of individuals that showed serum antibody responses after 2nd immunization.
CONCLUSIONS


We show that vaccination with a live attenuated H5N1 influenza vaccine lacking NS1 is safe and induces significant levels of vaccine-specific antibodies even after one immunization. The safety and immunogenicity data indicate that delNS1-H5N1 has the potential to fulfil the unmet need for an effective influenza vaccine in pandemic situations. (ClinicalTrials.gov identifier NCT03745274).",2019,delNS1-H5N1 was able to induce significant vaccine-specific serum antibody titers even at the lower dose level of 6.8 log10 TCID 50 /subject.,['healthy adult participants'],"['placebo', 'delNS1-H5N1', 'replication-deficient H5N1 influenza virus vaccine lacking NS1', 'delNS1-H5N1 vaccine at 6.8 log10 50% tissue culture infectious doses (TCID 50 )/subject or 7.5 log10', 'delNS1-H5N1 vaccine', 'live attenuated H5N1 vaccine (delNS1-H5N1']","['safe and well tolerated', 'serum antibody responses', 'pharyngeal erythema, rhinitis and throat irritation', 'Seroconversion', 'Vaccine-specific local IgA responses', 'body temperature', 'vaccine-specific serum antibody titers', 'safety and immunogenicity']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C2748361', 'cui_str': 'H5N1 influenza'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C1690986', 'cui_str': 'log10'}, {'cui': 'C0040284', 'cui_str': 'Tissue culture (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0455899', 'cui_str': 'Red throat (disorder)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0700184', 'cui_str': 'Throat irritation (finding)'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0784688,delNS1-H5N1 was able to induce significant vaccine-specific serum antibody titers even at the lower dose level of 6.8 log10 TCID 50 /subject.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Nicolodi', 'Affiliation': 'AVIR Green Hills Biotechnology, 1200 Vienna, Austria. Electronic address: nicolodi.christina@gmail.com.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Groiss', 'Affiliation': 'AVIR Green Hills Biotechnology, 1200 Vienna, Austria.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Kiselev', 'Affiliation': 'Research Institute of Influenza, Russian Academy of Medical Sciences, St. Petersburg, Russia.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Wolschek', 'Affiliation': 'AVIR Green Hills Biotechnology, 1200 Vienna, Austria.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Seipelt', 'Affiliation': 'AVIR Green Hills Biotechnology, 1200 Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Muster', 'Affiliation': 'AVIR Green Hills Biotechnology, 1200 Vienna, Austria.'}]",Vaccine,['10.1016/j.vaccine.2019.05.013']
1327,31153688,The influence of neonatal Bacille Calmette-Guérin (BCG) immunisation on heterologous vaccine responses in infants.,"INTRODUCTION


Bacillus Calmette-Guérin vaccine (BCG), one of the most widely used vaccines, does not only provide protection against tuberculosis and other mycobacterial infections, but also has non-specific (heterologous) immunomodulatory effects. In participants in a randomised trial, we investigated the effect of neonatal BCG immunisation on antibody responses to routine infant vaccines given in the first year of life.
METHODS


Antibodies against antigens in the diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b (Hib), and the 13-valent pneumococcal conjugate vaccines were measured in 91 (45 BCG-vaccinated, 46 BCG-naïve) infants one month after, and in 310 (169 BCG-vaccinated, 141 BCG-naïve) infants seven months after immunisation at 6 weeks, 4 and 6 months of age. In addition, antibodies against meningococcus C, Hib, measles, mumps, and rubella were measured in 147 (78 BCG-vaccinated, 69 BCG-naïve) infants one month after immunisation at 12 months of age. The seroprotection rates for each vaccine and the geometric mean concentrations (GMC) of antibodies were compared in BCG-vaccinated and BCG-naïve infants.
RESULTS


At 7 months of age, seroprotection rates were high in both BCG-vaccinated and BCG-naïve infants. At 13 months of age, seroprotection rates were lower than at 7 months of age, particularly for pertussis and a number of pneumococcal antigens, with generally higher rates for the latter in BCG-vaccinated infants. Although not statistically significant, antibody responses in BCG-vaccinated infants were consistently higher against diphtheria, tetanus, and pneumococcal antigens at both 7 and 13 months of age, and against measles and mumps at 13 months of age, but were lower against Hib one month after immunisation at both 7 and 13 months of age.
CONCLUSION


The immunomodulatory effect of BCG on antibody responses to heterologous vaccines adds to the evidence that BCG immunisation at birth has broad heterologous effects on the infant immune system.",2019,"At 7 months of age, seroprotection rates were high in both BCG-vaccinated and BCG-naïve infants.",['infants'],"['neonatal Bacille Calmette-Guérin (BCG) immunisation', 'Bacillus Calmette-Guérin vaccine (BCG', 'BCG', 'neonatal BCG immunisation']","['heterologous vaccine responses', 'antibody responses', 'seroprotection rates', 'geometric mean concentrations (GMC) of antibodies']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}]","[{'cui': 'C0439860', 'cui_str': 'Heterologous (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",,0.0402968,"At 7 months of age, seroprotection rates were high in both BCG-vaccinated and BCG-naïve infants.","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Zimmermann', 'Affiliation': ""Department of Paediatrics, The University of Melbourne, Parkville, Australia; Infectious Diseases Research Group, Murdoch Children's Research Institute, Parkville, Australia; Infectious Diseases Unit, The Royal Children's Hospital Melbourne, Parkville, Australia; Department of Pediatrics, Fribourg Hospital HFR and Faculty of Science and Medicine, University of Fribourg, Switzerland.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Donath', 'Affiliation': ""Department of Paediatrics, The University of Melbourne, Parkville, Australia; Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Australia.""}, {'ForeName': 'Kirsten P', 'Initials': 'KP', 'LastName': 'Perrett', 'Affiliation': ""Food Allergy Research Group and Melbourne Children's Trial Centre, Murdoch Children's Research Institute, Melbourne, Australia; Departments of Allergy and Immunology and General Medicine, Royal Children's Hospital, Melbourne, Australia; School of Population and Global Health, The University of Melbourne, Parkville, Australia.""}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Messina', 'Affiliation': ""Department of Paediatrics, The University of Melbourne, Parkville, Australia; Infectious Diseases Research Group, Murdoch Children's Research Institute, Parkville, Australia.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ritz', 'Affiliation': ""Department of Paediatrics, The University of Melbourne, Parkville, Australia; Infectious Diseases Unit, University of Basel Children's Hospital, Basel, Switzerland.""}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine, Radboud Institute for Molecular Life Sciences and Radboud Center for Infectious Diseases, Radboud University Nijmegen Medical Center, the Netherlands.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Flanagan', 'Affiliation': 'University of Tasmania, Launceston and Monash University, Clayton, Australia.'}, {'ForeName': 'Fiona R M', 'Initials': 'FRM', 'LastName': 'van der Klis', 'Affiliation': 'National Institute of Public Health and the Environment, Centre for Infectious Diseases, Bilthoven, the Netherlands.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Curtis', 'Affiliation': ""Department of Paediatrics, The University of Melbourne, Parkville, Australia; Infectious Diseases Research Group, Murdoch Children's Research Institute, Parkville, Australia; Infectious Diseases Unit, The Royal Children's Hospital Melbourne, Parkville, Australia. Electronic address: nigel.curtis@rch.org.au.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2019.03.016']
1328,31785587,Kinetics of oxytocin effects on amygdala and striatal reactivity vary between women and men.,"Accumulating evidence suggests that intranasal oxytocin (OXT; 24 IU) reduces amygdala responses to fear-related stimuli in men, while exerting inverse effects in women. However, OXT enhances activity of the brain reward system in both sexes. Importantly, a crucial and still open question is whether there are sex-specific dose-response relationships for the amygdala and striatal regions. To address this question, a total of 90 healthy women participated in a double-blind, placebo-controlled crossover functional magnetic resonance imaging (fMRI) study and the results were compared with our previous findings from men. Participants were randomly assigned to three doses of OXT (6 IU, 12 IU, and 24 IU) and completed an emotional face recognition task including fearful and happy faces of varying emotional intensities. Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women. While treatment effects on amygdala reactivity were evident at each given dose, the OXT effect on striatal responses to social stimuli was more pronounced with higher doses, but this dose-dependent effect did not survive correction for multiple comparisons. Importantly, OXT effects on amygdala and striatal activation significantly differed between sexes and striatal baseline sexual-dimorphic response patterns were diminished after administration of OXT. Our findings suggest that OXT increases the salience of social signals by strengthening the sensitivity for these signals in the amygdala and in the striatum in women, while OXT may primarily induce anxiolysis by reducing amygdala responses in men.",2020,"Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women.","['90 healthy women participated in a double-blind', 'women and men']","['OXT', 'placebo-controlled crossover functional magnetic resonance imaging (fMRI', 'oxytocin', 'intranasal oxytocin (OXT', 'placebo', 'emotional face recognition task including fearful and happy faces of varying emotional intensities']","['amygdala reactivity', 'amygdala and striatal reactivity', 'OXT effects on amygdala and striatal activation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",90.0,0.234159,"Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women.","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Lieberz', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany. Dirk-Scheele@gmx.de.'}, {'ForeName': 'Franny B', 'Initials': 'FB', 'LastName': 'Spengler', 'Affiliation': 'Institute for Psychology, University of Freiburg, 79104, Freiburg, Germany.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Matheisen', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Lìa', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Stoffel-Wagner', 'Affiliation': 'Institute of Clinical Chemistry and Clinical Pharmacology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kinfe', 'Affiliation': 'Department of Neurosurgery, Division of Functional Neurosurgery and Stereotaxy, Friedrich-Alexander University (FAU) Erlangen-Nürnberg, 91054, Erlangen, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0582-6']
1329,30825414,Online participatory intervention to promote and support exclusive breastfeeding: Randomized clinical trial.,"The support offered to mothers after hospital discharge can be decisive in maintaining exclusive breastfeeding during the first 6 months post-partum. The objective of this study was to assess the impact on the duration of exclusive breastfeeding of a participatory intervention using an online social network. A randomized clinical trial was performed involving 251 mother-child pairings in a university hospital in the Northeast of Brazil, 123 of which assigned to the intervention group and 128 to the control group. After hospital discharge, the intervention group was followed through a closed group of an online social network, where weekly posters were published on topics related to breastfeeding and an active communication was established with the mothers. The groups were interviewed monthly over the phone until the child reached 6 months of age. The duration of exclusive breastfeeding was calculated through survival analysis, and the effect of the intervention was estimated through the Cox regression model. The exclusive breastfeeding frequencies were higher in the intervention group in all follow-up months, reaching 33.3% in the sixth month versus 8.3% in the control group. The median exclusive breastfeeding duration was 149 days (95% CI [129.6, 168.4]) in the intervention group and 86 days (95% CI [64.9, 107.1]) in the control group (P < 0.0001). The proportional risk of early interruption of exclusive breastfeeding was 0.38 (95% CI [0.28, 0.51], P < 0.0001). This intervention had a positive impact on the duration and frequency of exclusive breastfeeding.",2019,"The exclusive breastfeeding frequencies were higher in the intervention group in all follow-up months, reaching 33.3% in the sixth month versus 8.3% in the control group.","['251 mother-child pairings in a university hospital in the Northeast of Brazil, 123 of which assigned to the intervention group and 128 to the control group']",['Online participatory intervention to promote and support exclusive breastfeeding'],"['exclusive breastfeeding frequencies', 'proportional risk of early interruption of exclusive breastfeeding', 'median exclusive breastfeeding duration', 'duration of exclusive breastfeeding', 'duration and frequency of exclusive breastfeeding']","[{'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}]","[{'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205351', 'cui_str': 'Proportional (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",251.0,0.0762054,"The exclusive breastfeeding frequencies were higher in the intervention group in all follow-up months, reaching 33.3% in the sixth month versus 8.3% in the control group.","[{'ForeName': 'Débora Silva', 'Initials': 'DS', 'LastName': 'Cavalcanti', 'Affiliation': 'Post-Graduate Program in Nutrition, Pernambuco Federal University, Recife, Brazil.'}, {'ForeName': 'Caroline Sousa', 'Initials': 'CS', 'LastName': 'Cabral', 'Affiliation': 'Post-Graduate Program in Nutrition, Paraíba Federal University, João Pessoa, Brazil.'}, {'ForeName': 'Rodrigo Pinheiro', 'Initials': 'RP', 'LastName': 'de Toledo Vianna', 'Affiliation': 'Post-Graduate Program in Nutrition, Paraíba Federal University, João Pessoa, Brazil.'}, {'ForeName': 'Mônica Maria', 'Initials': 'MM', 'LastName': 'Osório', 'Affiliation': 'Post-Graduate Program in Nutrition, Pernambuco Federal University, Recife, Brazil.'}]",Maternal & child nutrition,['10.1111/mcn.12806']
1330,31591117,Early Bayesian Dose Adjustment of Vancomycin Continuous Infusion in Children: a Randomized Controlled Trial.,"Methicillin-resistant staphylococcal infections are a global burden. Area under the serum concentration-time curve to minimum inhibitory concentration (AUC/MIC) ratio is the pharmacokinetic (PK) parameter that best predicts vancomycin efficacy. Its therapeutic range is narrow, difficult to achieve because of a wide intersubject variability, especially in children, and is not routinely targeted since the AUC is rarely available. We investigated if an early Bayesian dose adjustment would increase the rate of vancomycin target attainment, in the first 24 hours of treatment (H24), in children.We conducted a single-centre randomized controlled trial in 4 pediatric departments of Necker-Enfants Malades hospital (Paris, France). Patients aged 3 months to 17 years for whom intravenous vancomycin was started were eligible and randomized in a 1:1 ratio: routine care were compared with an early vancomycin therapeutic drug monitoring (3h after treatment initiation) followed by an early Bayesian dose adjustment using a previously published population-based PK model that included age, bodyweight and serum creatinine as covariates. The primary outcome was the proportion of patients of each group achieving vancomycin therapeutic range at H24, defined by AUC 0-24 /MIC≥400 and AUC 0-24  ≤800mg-h/L.Ninety-nine patients were enrolled: 49 were randomized to the Bayesian group and 50 to the control group. Modified intention-to-treat analysis included 82 patients: 85% of Bayesian group patients achieved H24 vancomycin target versus 57% of control group patients (p=0.007) with no difference regarding iatrogenic events. Early Bayesian dose adjustment increased the proportion of children achieving vancomycin target at H24, which may improve clinical outcomes of methicillin-resistant staphylococcal infections.",2019,Modified intention-to-treat analysis included 82 patients: 85% of Bayesian group patients achieved H24 vancomycin target versus 57% of control group patients (p=0.007) with no difference regarding iatrogenic events.,"['4 pediatric departments of Necker-Enfants Malades hospital (Paris, France', 'at H24, defined by AUC 0-24 /MIC≥400 and AUC 0-24  ≤800mg-h/L.Ninety-nine patients were enrolled: 49', 'Patients aged 3 months to 17 years for whom intravenous', 'Children']","['Vancomycin Continuous Infusion', 'vancomycin', 'vancomycin therapeutic drug monitoring']","['rate of vancomycin target attainment', 'proportion of patients of each group achieving vancomycin therapeutic range', 'iatrogenic events', 'serum concentration-time curve to minimum inhibitory concentration (AUC/MIC) ratio']","[{'cui': 'C0587482', 'cui_str': 'Pediatric department (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0331677', 'cui_str': 'Paris (organism)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C1720825', 'cui_str': 'Therapeutic Drug Monitoring'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439669', 'cui_str': 'Iatrogenic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",82.0,0.178573,Modified intention-to-treat analysis included 82 patients: 85% of Bayesian group patients achieved H24 vancomycin target versus 57% of control group patients (p=0.007) with no difference regarding iatrogenic events.,"[{'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Berthaud', 'Affiliation': 'EA 7323 - Pharmacology and Therapeutic Evaluation in children and pregnant women, Paris Descartes University, Sorbonne Paris Cité University, Paris, France. romain.berthaud@aphp.fr.'}, {'ForeName': 'Sihem', 'Initials': 'S', 'LastName': 'Benaboud', 'Affiliation': 'EA 7323 - Pharmacology and Therapeutic Evaluation in children and pregnant women, Paris Descartes University, Sorbonne Paris Cité University, Paris, France.'}, {'ForeName': 'Déborah', 'Initials': 'D', 'LastName': 'Hirt', 'Affiliation': 'EA 7323 - Pharmacology and Therapeutic Evaluation in children and pregnant women, Paris Descartes University, Sorbonne Paris Cité University, Paris, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Genuini', 'Affiliation': 'Pediatric Intensive Care Unit, Necker-Enfants Malades hospital, Assistance Publique-Hoôpitaux de Paris, Paris, France.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Oualha', 'Affiliation': 'EA 7323 - Pharmacology and Therapeutic Evaluation in children and pregnant women, Paris Descartes University, Sorbonne Paris Cité University, Paris, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Castelle', 'Affiliation': 'Department of Pediatric Immunology, Hematology and Rheumatology, Necker-Enfants Malades hospital, Assistance Publique-Hoôpitaux de Paris, Paris, France.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Briand', 'Affiliation': 'Department of Pediatric Immunology, Hematology and Rheumatology, Necker-Enfants Malades hospital, Assistance Publique-Hoôpitaux de Paris, Paris, France.'}, {'ForeName': 'Solène', 'Initials': 'S', 'LastName': 'Artru', 'Affiliation': 'Department of Pediatric Gastroenterology, Hepatology and Nutrition, Necker-Enfants Malades hospital, Assistance Publique-Hoôpitaux de Paris, Paris, France.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Norsa', 'Affiliation': 'Department of Pediatric Gastroenterology, Hepatology and Nutrition, Necker-Enfants Malades hospital, Assistance Publique-Hoôpitaux de Paris, Paris, France.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Boyer', 'Affiliation': 'Department of Pediatric Nephrology, Necker-Enfants Malades hospital, Assistance Publique-Hoôpitaux de Paris, Paris, France.'}, {'ForeName': 'Frantz', 'Initials': 'F', 'LastName': 'Foissac', 'Affiliation': 'EA 7323 - Pharmacology and Therapeutic Evaluation in children and pregnant women, Paris Descartes University, Sorbonne Paris Cité University, Paris, France.'}, {'ForeName': 'Naïm', 'Initials': 'N', 'LastName': 'Bouazza', 'Affiliation': 'EA 7323 - Pharmacology and Therapeutic Evaluation in children and pregnant women, Paris Descartes University, Sorbonne Paris Cité University, Paris, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Tréluyer', 'Affiliation': 'EA 7323 - Pharmacology and Therapeutic Evaluation in children and pregnant women, Paris Descartes University, Sorbonne Paris Cité University, Paris, France.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01102-19']
1331,31205205,Attending to Pesticide Exposure and Heat Illness Among Farmworkers: Results From an Attention Placebo-Controlled Evaluation Design.,"OBJECTIVE


The aim of this study was to determine the effectiveness of curricula for improving knowledge and attitudes pertaining to pesticide exposure and heat illness among immigrant Latino farmworkers.
METHODS


A pesticide safety curriculum informed by the revised Worker Protection Standard (WPS) was tested against an attention placebo-controlled curriculum (heat illness) in a sample of Latino farmworkers (N = 127).
RESULTS


Pesticide safety knowledge increased in the overall sample, but did not differ by curriculum assignment. Pesticide safety behavioral intentions increased among participants in the pesticide safety curriculum but decreased among those in the other curriculum (P < 0.05). Heat illness knowledge and behavioral intentions increased more for farmworkers assigned to the heat illness than the pesticide safety curriculum.
CONCLUSION


The developed curricula show good promise for meeting the spirit of the revised WPS and for reducing the burden of heat-related fatality and morbidity among Latino farmworkers.",2019,Pesticide safety behavioral intentions increased among participants in the pesticide safety curriculum but decreased among those in the other curriculum (p < .05).,"['Attending to Pesticide Exposure & Heat Illness among Farmworkers', 'immigrant Latino farmworkers', 'heat illness) in a sample of Latino farmworkers (N=127']",['placebo-controlled curriculum'],"['pesticide safety curriculum', 'Heat illness knowledge and behavioral intentions', 'Pesticide safety behavioral intentions']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0031253', 'cui_str': 'Pesticides'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1456556', 'cui_str': 'Heat illness'}, {'cui': 'C0221460', 'cui_str': 'Agricultural Workers'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]","[{'cui': 'C0031253', 'cui_str': 'Pesticides'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C1456556', 'cui_str': 'Heat illness'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0360092,Pesticide safety behavioral intentions increased among participants in the pesticide safety curriculum but decreased among those in the other curriculum (p < .05).,"[{'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Grzywacz', 'Affiliation': 'Florida State University, Department of Family & Child Sciences, Tallahassee, FL (Dr Grzywacz, Dr Gonzales-Backen, Marín, Trejo, Gudino), Migrant Clinicians Network, Division of Environmental and Occupational Health, Salisbury, MD (Liebman), Farmworker Association of Florida, Apopka, FL (Economos, Dr Tovar-Aguilar).'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gonzales-Backen', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Liebman', 'Affiliation': ''}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Marín', 'Affiliation': ''}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Trejo', 'Affiliation': ''}, {'ForeName': 'Cecilia Ordaz', 'Initials': 'CO', 'LastName': 'Gudino', 'Affiliation': ''}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Economos', 'Affiliation': ''}, {'ForeName': 'J Antonio', 'Initials': 'JA', 'LastName': 'Tovar-Aguilar', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001650']
1332,31153114,The effect of NaOCl and heat treatment on static and dynamic mechanical properties and chemical changes of dentine.,"OBJECTIVES


To determine the effect of heat on flexural strength (FS), maximum strain (MS), storage modulus (SM), tan delta (TD) and chemical changes through micro-Raman spectroscopy of dentine exposed to 2.5% NaOCl or saline.
METHOD


ology: Dentine bars were randomly allocated to 8 test groups. Half (groups 2,4,6,8) were treated with NaOCl for 20 min; the rest (groups 1,3,5,7) remained in saline. FS/MS were measured in groups 1-4 (n = 15) (3/4 were also heated to 200 °C & re-hydrated in saline). Micro-Raman spectroscopy was performed on bars from groups 1-4. SM/TD were measured in 5-8: in 5/6 (n = 10), repeated after heating (200 °C), then following re-hydration; in 7/8 (n = 3) after heating to 25-185 °C.
RESULTS


Increase in MS on heat and FS/MS on heat + NaOCl was not significant (P > 0.05). SM increased (P = 0.06) after heat treatment but reduced to initial state after rehydration (P = 0.03). TD did not change (P = 0.4) after heat (200 °C) treatment but rehydration increased it compared with pre-treatment state (P = 0.001). For dentine bars pre-treated with NaOCl, SM did not change (P = 0.6) after heat (200 °C) treatment or rehydration but TD significantly increased (P = 0.02) upon re-hydration compared with pre- (P=0.007), or post- (P = 0.03) heat-treatment states. SM and TD varied between 25-185 °C with no consistent trend amongst the NaOCl pre-treated bars. Micro-Raman only detected chemical changes following NaOCl treatment in the mineral phase.
CONCLUSIONS


Exposure of dentine bars to heat and NaOCl produced only moderate changes to quasi-static but marked changes to viscoelastic properties, which may be explained by chemical alterations.",2019,"For dentine bars pre-treated with NaOCl, SM did not change (P = 0.6) after heat (200 °C) treatment or rehydration but TD significantly increased (P = 0.02) upon re-hydration compared with pre- (P=0.007), or post-",['ology'],"['saline', 'NaOCl', 'NaOCl and heat treatment']","['SM and TD', 'static and dynamic mechanical properties and chemical changes of dentine', 'MS on heat and FS/MS on heat\xa0+\xa0NaOCl', 'SM', 'SM/TD', 'flexural strength (FS), maximum strain (MS), storage modulus (SM), tan delta (TD) and chemical changes through micro-Raman spectroscopy of dentine', 'FS/MS']",[],"[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C4704755', 'cui_str': 'Flexural Properties'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C1537110', 'cui_str': 'Skin tanning, function (observable entity)'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0037815', 'cui_str': 'Raman Spectroscopy'}]",,0.027041,"For dentine bars pre-treated with NaOCl, SM did not change (P = 0.6) after heat (200 °C) treatment or rehydration but TD significantly increased (P = 0.02) upon re-hydration compared with pre- (P=0.007), or post-","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Karunanayake', 'Affiliation': 'Unit of Endodontology, Division of Restorative Dental Science, UCL Eastman Dental Institute, University College London, London, UK.'}, {'ForeName': 'Y-L', 'Initials': 'YL', 'LastName': 'Ng', 'Affiliation': 'Unit of Endodontology, Division of Restorative Dental Science, UCL Eastman Dental Institute, University College London, London, UK. Electronic address: y.ng@ucl.ac.uk.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Knowles', 'Affiliation': 'Biomaterials & Tissue Engineering, UCL Eastman Dental Institute, University College London, London, UK; Institute of Tissue Regeneration Engineering (ITREN) and Department of NanobiomedicalScience and BK21 Plus NBM, Global Research Center for Regenerative Medicine, DankookUniversity, 518-10, Anseo-dong, Dongnam-gu, Cheonan, Chungcheongnam-do, South Korea; The Discoveries Centre for Regenerative and Precision Medicine, UCL Campus, GowerStreet, London, WC1E 6BT, UK.'}, {'ForeName': 'A H S', 'Initials': 'AHS', 'LastName': 'Delgado', 'Affiliation': 'Biomaterials & Tissue Engineering, UCL Eastman Dental Institute, University College London, London, UK.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Young', 'Affiliation': 'Biomaterials & Tissue Engineering, UCL Eastman Dental Institute, University College London, London, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gulabivala', 'Affiliation': 'Unit of Endodontology, Division of Restorative Dental Science, UCL Eastman Dental Institute, University College London, London, UK.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Nazhat', 'Affiliation': 'Department of Mining and Materials Engineering, McGill University, Montreal, Qc, H3A 0C5, Canada.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.05.042']
1333,31076187,Modeling the acute pharmacological response to selective serotonin reuptake inhibitors in human brain using simultaneous PET/MR imaging.,"Pharmacological imaging of the effects of selective serotonin reuptake inhibitors (SSRI) may aid the clarification of their mechanism of action and influence treatment of highly prevalent neuropsychiatric conditions if the detected effects could be related to patient outcomes. In a randomized double-blind design, 38 healthy participants received a constant infusion of 8 mg citalopram or saline during either their first or second of two PET/MR scans. Resting-state functional MRI (fMRI) was acquired simultaneously with PET data on the binding of serotonin transporters (5-HTT) using [ 11 C]DASB. Three different approaches for modeling of pharmacological fMRI response were tested separately. These relied on the use of regressors corresponding to (1) the drug infusion paradigm, (2) time courses of citalopram plasma concentrations and (3) changes in 5-HTT binding measured in each individual, respectively. Furthermore, the replication of results of a widely used model-free analysis method was attempted which assesses the deviation of signal in discrete time bins of fMRI data acquired after start of drug infusion. Following drug challenge, average 5-HTT occupancy was 69±7% and peak citalopram plasma levels were 111.8 ± 21.1 ng/ml. None of the applied methods could detect significant differences in the pharmacological response between SSRI and placebo scans. The failed replication of SSRI effects reported in the literature despite a threefold larger sample size highlights the importance of appropriate correction for family-wise error in order to avoid spurious results in pharmacological imaging. This calls for the development of analysis methods which take regional specialization and the dynamics of brain activity into account.",2019,"Following drug challenge, average 5-HTT occupancy was 69±7% and peak citalopram plasma levels were 111.8 ± 21.1 ng/ml.",['38 healthy participants'],"['constant infusion of 8\u202fmg citalopram or saline', 'selective serotonin reuptake inhibitors (SSRI']","['pharmacological response', '5-HTT binding', 'peak citalopram plasma levels', 'average 5-HTT occupancy']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",38.0,0.118893,"Following drug challenge, average 5-HTT occupancy was 69±7% and peak citalopram plasma levels were 111.8 ± 21.1 ng/ml.","[{'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Gryglewski', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Klöbl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Neydher', 'Initials': 'N', 'LastName': 'Berroterán-Infante', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine, Medical University of Vienna, Austria.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Rischka', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Balber', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine, Medical University of Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vanicek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Pichler', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine, Medical University of Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kautzky', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Klebermass', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine, Medical University of Vienna, Austria.'}, {'ForeName': 'Murray Bruce', 'Initials': 'MB', 'LastName': 'Reed', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Chrysoula', 'Initials': 'C', 'LastName': 'Vraka', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine, Medical University of Vienna, Austria.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Hienert', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Gregory Miles', 'Initials': 'GM', 'LastName': 'James', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Silberbauer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Godber Mathis', 'Initials': 'GM', 'LastName': 'Godbersen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Unterholzner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Michenthaler', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hartenbach', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine, Medical University of Vienna, Austria.'}, {'ForeName': 'Edda', 'Initials': 'E', 'LastName': 'Winkler-Pjrek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wadsak', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine, Medical University of Vienna, Austria; Center for Biomarker Research in Medicine (CBmed), Graz, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Mitterhauser', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine, Medical University of Vienna, Austria; Ludwig Boltzmann Institute Applied Diagnostics, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hacker', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine, Medical University of Vienna, Austria.'}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Kasper', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Lanzenberger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria. Electronic address: rupert.lanzenberger@meduniwien.ac.at.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.04.001']
1334,31771599,Can a multicomponent multidisciplinary implementation package change physicians' and nurses' perceptions and practices regarding thrombolysis for acute ischemic stroke? An exploratory analysis of a cluster-randomized trial.,"BACKGROUND


The Thrombolysis ImPlementation in Stroke (TIPS) trial tested the effect of a multicomponent, multidisciplinary, collaborative intervention designed to increase the rates of intravenous thrombolysis via a cluster randomized controlled trial at 20 Australian hospitals (ten intervention, ten control). This sub-study investigated changes in self-reported perceptions and practices of physicians and nurses working in acute stroke care at the participating hospitals.
METHODS


A survey with 74 statements was administered during the pre- and post-intervention periods to staff at 19 of the 20 hospitals. An exploratory factor analysis identified the structure of the survey items and linear mixed modeling was applied to the final survey domain scores to explore the differences between groups over time.
RESULT


The response rate was 45% for both the pre- (503 out of 1127 eligible staff from 19 hospitals) and post-intervention (414 out of 919 eligible staff from 18 hospitals) period. Four survey domains were identified: (1) hospital performance indicators, feedback, and training; (2) personal perceptions about thrombolysis evidence and implementation; (3) personal stroke skills and hospital stroke care policies; and (4) emergency and ambulance procedures. There was a significant pre- to post-intervention mean increase (0.21 95% CI 0.09; 0.34; p < 0.01) in scores relating to hospital performance indicators, feedback, and training; for the intervention hospitals compared to control hospitals. There was a corresponding increase in mean scores regarding perceptions about the thrombolysis evidence and implementation (0.21, 95% CI 0.06; 0.36; p < 0.05). Sub-group analysis indicated that the improvements were restricted to nurses' responses.
CONCLUSION


TIPS resulted in changes in some aspects of nurses' perceptions relating to the evidence for intravenous thrombolysis and its implementation and hospital performance indicators, feedback, and training. However, there is a need to explore further strategies for influencing the views of physicians given limited statistical power in the physician sample.
TRIAL REGISTRATION


ACTRN12613000939796, UTN: U1111-1145-6762.",2019,"There was a corresponding increase in mean scores regarding perceptions about the thrombolysis evidence and implementation (0.21, 95% CI 0.06; 0.36; p < 0.05).","['acute stroke care at the participating hospitals', '20 Australian hospitals (ten intervention, ten control']",['TIPS'],"['hospital performance indicators, feedback, and training; (2) personal perceptions about thrombolysis evidence and implementation; (3) personal stroke skills and hospital stroke care policies; and (4) emergency and ambulance procedures', 'response rate', 'mean scores regarding perceptions about the thrombolysis evidence and implementation']","[{'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0002422', 'cui_str': 'Ambulances'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",919.0,0.128299,"There was a corresponding increase in mean scores regarding perceptions about the thrombolysis evidence and implementation (0.21, 95% CI 0.06; 0.36; p < 0.05).","[{'ForeName': 'Md Golam', 'Initials': 'MG', 'LastName': 'Hasnain', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, NSW, Australia.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, NSW, Australia.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Ryan', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, NSW, Australia.'}, {'ForeName': 'Isobel J', 'Initials': 'IJ', 'LastName': 'Hubbard', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, NSW, Australia.'}, {'ForeName': 'Alix', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'Hunter Medical Research Institute (HMRI), New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, NSW, Australia.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Grady', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, NSW, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Jayakody', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, NSW, Australia.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Attia', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, NSW, Australia.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, NSW, Australia. chris.paul@newcastle.edu.au.'}]",Implementation science : IS,['10.1186/s13012-019-0940-0']
1335,31230881,"An inactivated enterovirus 71 vaccine is safe and immunogenic in healthy adults: A phase I, double blind, randomized, placebo-controlled, study of two dosages.","BACKGROUND


Hand, foot and mouth disease (HFMD), especially that caused by enterovirus 71 (EV71) infection, is a public health concern in the Asia-Pacific region. We report a phase I clinical trial of an EV71 candidate vaccine (INV21) based on a binary ethylenimine inactivated B2 sub-genotype formulated with aluminum hydroxide.
METHODS


In this double-blind, placebo-controlled, randomized, dose escalation study adult volunteers received two vaccinations 28 days apart of low or high dose formulations of the candidate vaccine and were then monitored for safety and reactogenicity for four weeks after each dose, and for their immune responses up to 28 weeks.
RESULTS


Of 36 adults enrolled, 35 completed the study as planned. Either no or mild adverse events were observed, mainly injection site pain and tiredness. Seroconversion was 100% after two vaccinations. High geometric mean neutralizing antibody titers (GMT) were observed 14 days post first dose, peaking 14 days post second dose (at Day 42) in both high and low dose groups; GMTs on days 14, 28, 42, and 56 were 128, 81, 323, 203 and 144, 100, 451, 351 in low- and high-dose groups, respectively. Titers for both doses declined gradually to Day 196 but remained higher than baseline and the placebo groups, which had low GMTs throughout the duration of the study. Cross-neutralizing antibody activity against heterologous sub-genotypes was demonstrated.
CONCLUSION


These data show that the EV71 candidate vaccine is safe and immunogenic in adults and supports further clinical development as a potential pediatric vaccine by initiating a dose-escalation study for determining the dose-dependent safety and immunogenicity of the vaccine in young naïve children.",2019,"Titers for both doses declined gradually to Day 196 but remained higher than baseline and the placebo groups, which had low GMTs throughout the duration of the study.","['young naïve children', 'healthy adults', '36 adults enrolled, 35 completed the study as planned']","['EV71 candidate vaccine (INV21', 'EV71 candidate vaccine', 'placebo', 'ethylenimine inactivated B2 sub-genotype formulated with aluminum hydroxide']","['High geometric mean neutralizing antibody titers (GMT', 'safety and reactogenicity', 'Seroconversion', 'mild adverse events', 'injection site pain and tiredness']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052794', 'cui_str': 'aziridine'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",36.0,0.321554,"Titers for both doses declined gradually to Day 196 but remained higher than baseline and the placebo groups, which had low GMTs throughout the duration of the study.","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tambyah', 'Affiliation': 'Department of Medicine, NUH Investigational Medicine Unit, Yong Loo Lin School of Medicine, National University of Singapore, 1E, Kent Ridge Road, NUHS Tower Block, Level 10, Singapore 119228, Singapore.'}, {'ForeName': 'Jolene', 'Initials': 'J', 'LastName': 'Oon', 'Affiliation': 'Department of Medicine, NUH Investigational Medicine Unit, Yong Loo Lin School of Medicine, National University of Singapore, 1E, Kent Ridge Road, NUHS Tower Block, Level 10, Singapore 119228, Singapore.'}, {'ForeName': 'Rosmonaliza', 'Initials': 'R', 'LastName': 'Asli', 'Affiliation': 'Department of Medicine, NUH Investigational Medicine Unit, Yong Loo Lin School of Medicine, National University of Singapore, 1E, Kent Ridge Road, NUHS Tower Block, Level 10, Singapore 119228, Singapore.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kristanto', 'Affiliation': 'Department of Medicine, NUH Investigational Medicine Unit, Yong Loo Lin School of Medicine, National University of Singapore, 1E, Kent Ridge Road, NUHS Tower Block, Level 10, Singapore 119228, Singapore.'}, {'ForeName': 'Shi-Hsia', 'Initials': 'SH', 'LastName': 'Hwa', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals Asia Pacific Pte Ltd, 21 Biopolis Road, Nucleos South Tower Level 4, Singapore 138567, Singapore.'}, {'ForeName': 'Fue', 'Initials': 'F', 'LastName': 'Vang', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals USA, 40 Landsdowne Street, Cambridge, MA 02139, USA.'}, {'ForeName': 'Lovkesh', 'Initials': 'L', 'LastName': 'Karwal', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals USA, 40 Landsdowne Street, Cambridge, MA 02139, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Fuchs', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals USA, 40 Landsdowne Street, Cambridge, MA 02139, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Santangelo', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals USA, 40 Landsdowne Street, Cambridge, MA 02139, USA.'}, {'ForeName': 'Gilad S', 'Initials': 'GS', 'LastName': 'Gordon', 'Affiliation': 'Takeda Vaccines, Inc., Takeda Pharmaceuticals USA, Fort Collins, CO, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Thomson', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals Asia Pacific Pte Ltd, 21 Biopolis Road, Nucleos South Tower Level 4, Singapore 138567, Singapore.'}, {'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals Asia Pacific Pte Ltd, 21 Biopolis Road, Nucleos South Tower Level 4, Singapore 138567, Singapore.'}, {'ForeName': 'Hansi', 'Initials': 'H', 'LastName': 'Dean', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals USA, 40 Landsdowne Street, Cambridge, MA 02139, USA.'}, {'ForeName': 'Subash C', 'Initials': 'SC', 'LastName': 'Das', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals USA, 40 Landsdowne Street, Cambridge, MA 02139, USA. Electronic address: subash.das@takeda.com.'}, {'ForeName': 'Dan T', 'Initials': 'DT', 'LastName': 'Stinchcomb', 'Affiliation': 'Takeda Vaccines, Inc., Takeda Pharmaceuticals USA, Fort Collins, CO, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.06.023']
1336,31740595,"Stakeholder engagement increases transparency, satisfaction, and civic action.","This study evaluates the effectiveness of a Stakeholder Engagement (SE) intervention in improving outcomes for communities affected by oil and gas extraction in Western Uganda. The study design is a randomized controlled trial where villages are randomly assigned to a treatment group (participating in SE) or a control group (not participating). Data are collected via household surveys at baseline and end line in 107 villages in the Albertine Graben. We find that SE improves transparency, civic activity, and satisfaction with issues that most concern the people under study. While satisfaction has improved, it is too early to ascertain whether these interventions improve long-term outcomes. These results are robust when controlling for spillover effects and other subregional fixed effects.",2019,This study evaluates the effectiveness of a Stakeholder Engagement (SE) intervention in improving outcomes for communities affected by oil and gas extraction in Western Uganda.,"['communities affected by oil and gas extraction in Western Uganda', '107 villages in the Albertine Graben']","['Stakeholder Engagement (SE) intervention', 'SE']","['transparency, civic activity, and satisfaction', 'transparency, satisfaction, and civic action']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}]",[],"[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]",,0.109015,This study evaluates the effectiveness of a Stakeholder Engagement (SE) intervention in improving outcomes for communities affected by oil and gas extraction in Western Uganda.,"[{'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Coleman', 'Affiliation': 'Department of Political Science, Florida State University, Tallahassee, FL 32306-2230; ecoleman@fsu.edu.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Manyindo', 'Affiliation': 'Maendeleo ya Jamii, Kampala, Uganda.'}, {'ForeName': 'A Rani', 'Initials': 'AR', 'LastName': 'Parker', 'Affiliation': 'Business-Community Synergies, Takoma Park, MD 20912.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Schultz', 'Affiliation': 'Department of Political Science, Florida State University, Tallahassee, FL 32306-2230.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1908433116']
1337,31103520,The Effect of Patient-Controlled Oral Analgesia for Acute Abdominal Pain after Discharge.,"BACKGROUND


During hospitalization, patients who were admitted with acute abdominal pain must be prepared to care for themselves at home after discharge to continue established treatment, promote recovery, and avoid readmission.
AIMS


Our aim was to investigate the quality of pain management after discharge, when patient-controlled oral analgesia was compared with standard care for patients admitted to hospital with acute abdominal pain. The primary outcome measures were pain intensity and patient perception of care. The secondary outcome measures were pain interference with activity, affective experiences, side effects, and use of analgesics.
DESIGN


A questionnaire study measuring the effect of an intervention on patient-controlled oral analgesics.
SETTINGS


An emergency department and a surgical department in Denmark.
PARTICIPANTS


Patients admitted to hospital with acute abdominal pain.
METHODS


A pre- and postintervention study was conducted in an emergency department and a surgical department with three subunits. Data were collected using a Danish modified Revised American Pain Society Patient Outcome Questionnaire with five subscales (scale 0-10) completed in weeks 1 and 4 after discharge.
RESULTS


In total, 117 patients were included. The median scores at week 1 and week 4 in the control and intervention groups were, respectively, 2/1 and 1/0 on the pain subscale (p = .11/.16), 3/0 and 3/0 on the activity subscale (p = .19/.80), 1/0 and 0/0 on the emotional subscale (p = .02/.72), 1/0 and 1/0 on the side effect subscale (p = .95/.99), and 8/5 and 7/7 on the patient perception subscale (p = .35/.49). There was no significant difference in the use of analgesics at week 1.
CONCLUSIONS


Patient-controlled oral analgesia during the hospital stay did not improve the quality of pain management after discharge.",2019,"There was no significant difference in the use of analgesics at week 1.
","['patients admitted to hospital with acute abdominal pain', 'A pre- and postintervention study was conducted in an emergency department and a surgical department with three subunits', 'Patients admitted to hospital with acute abdominal pain', 'Acute Abdominal Pain after Discharge', 'An emergency department and a surgical department in Denmark', '117 patients were included', 'patients who were admitted with acute abdominal pain']",['Patient-Controlled Oral Analgesia'],"['side effect subscale', 'emotional subscale', 'pain intensity and patient perception of care', 'pain subscale', 'activity subscale', 'patient perception subscale', 'pain interference with activity, affective experiences, side effects, and use of analgesics', 'quality of pain management', 'median scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0740577', 'cui_str': 'Acute abdominal pain (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0587503', 'cui_str': 'Surgical department (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",117.0,0.0600729,"There was no significant difference in the use of analgesics at week 1.
","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Schultz', 'Affiliation': 'Surgical Department, Odense University Hospital, Odense, Denmark; Institute of Clinical Research, University of Southern Denmark, Odense, Denmark; OPEN (Odense Patient Data Explorative Network), Odense University Hospital, Odense, Denmark. Electronic address: helen.schultz@rsyd.dk.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Schultz Larsen', 'Affiliation': 'Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'Institute of Clinical Research, University of Southern Denmark, Odense, Denmark; OPEN (Odense Patient Data Explorative Network), Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Qvist', 'Affiliation': 'Surgical Department, Odense University Hospital, Odense, Denmark; Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2019.02.004']
1338,32410400,Expression of concern: Nifedipine alone or combined with sildenafil citrate for management of threatened preterm labour: a randomised trial.,,2020,,['threatened preterm labour'],['Nifedipine alone or combined with sildenafil citrate'],[],"[{'cui': 'C0022876', 'cui_str': 'Premature labor'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}]",[],,0.271786,,[],BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16082']
1339,31221502,"Multiple-dose clinical pharmacology of ACT-541468, a novel dual orexin receptor antagonist, following repeated-dose morning and evening administration.","ACT-541468 is a dual orexin receptor antagonist with sleep-promoting effects in humans. Following entry-into-humans, its pharmacokinetics (PK) including dose-proportionality and accumulation, pharmacodynamics (PD), safety, and tolerability following multiple-ascending oral dose (MAD) administration in the morning, and next-day residual effects after repeated evening administration were investigated in a double-blind, placebo-controlled, randomized study. 31 healthy male and female subjects in 3 dose-groups (10, 25, and 75 mg) received study drug in the morning for 5 days (MAD part), and 20 healthy subjects received 25 mg in the evening for 1 week (evening part). PK, PD (saccadic peak velocity (SPV), adaptive tracking, body sway, Bond and Lader visual analogue scales (VAS), Karolinska Sleepiness Scale (KSS), VAS Bowdle for assessment of psychedelic effects), Digit Symbol Substitution Test (DSST), and Simple Reaction Time Test (SRTT), safety, and tolerability were assessed. ACT-541468 was absorbed with a median t max  of 1.0-2.0 h across the 3 dose groups. The geometric mean elimination half-life (t ½ ) on Day 5 was between 5.6 and 8.5 h, and the exposure (area under the curve (AUC)) showed dose proportionality. No accumulation and no influence of sex on the multiple-dose PK parameters of ACT-541468 was observed. No effects were observed at 10 mg. Administration of 25 and 75 mg during the day showed clear dose-dependent effects on the PD parameters, while next-day effects were absent after evening administration of 25 mg. The drug was safe and well tolerated. In conclusion, multiple-dose PK/PD of ACT-541468 were compatible with a drug designated to treat insomnia.",2019,"The geometric mean elimination half-life (t ½ ) on Day 5 was between 5.6 and 8.5 h, and the exposure (area under the curve (AUC)) showed dose proportionality.","['31 healthy male and female subjects in 3 dose-groups (10, 25, and 75\u202fmg) received study drug in the morning for 5 days (MAD part), and 20 healthy subjects']",[],"['safe and well tolerated', 'PD parameters', 'pharmacokinetics (PK) including dose-proportionality and accumulation, pharmacodynamics (PD), safety, and tolerability', 'PK, PD (saccadic peak velocity (SPV), adaptive tracking, body sway, Bond and Lader visual analogue scales (VAS), Karolinska Sleepiness Scale (KSS), VAS Bowdle for assessment of psychedelic effects), Digit Symbol Substitution Test (DSST), and Simple Reaction Time Test (SRTT), safety, and tolerability']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018533', 'cui_str': 'Psychedelic Agents'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",31.0,0.0809589,"The geometric mean elimination half-life (t ½ ) on Day 5 was between 5.6 and 8.5 h, and the exposure (area under the curve (AUC)) showed dose proportionality.","[{'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Muehlan', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123 Allschwil, Switzerland. Electronic address: clemens.muehlan@idorsia.com.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Brooks', 'Affiliation': 'Centre for Human Drug Research (CHDR), Zernikedreef 8, 2333 CL Leiden, the Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Zuiker', 'Affiliation': 'Centre for Human Drug Research (CHDR), Zernikedreef 8, 2333 CL Leiden, the Netherlands.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'van Gerven', 'Affiliation': 'Centre for Human Drug Research (CHDR), Zernikedreef 8, 2333 CL Leiden, the Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123 Allschwil, Switzerland.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.05.009']
1340,31792263,"Aging, sex and cognitive Theory of Mind: a transcranial direct current stimulation study.","Aging is accompanied by changes in cognitive abilities and a great interest is spreading among researchers about aging impact on social cognition skills, such as the Theory of Mind (ToM). Transcranial direct current stimulation (tDCS) has been used in social cognition studies founding evidence of sex-related different effects on cognitive ToM task in a young people sample. In this randomized, double-blind, sham-controlled study, we applied one active and one sham tDCS session on the medial prefrontal cortex (mPFC) during a cognitive ToM task, including both social (i.e., communicative) and nonsocial (i.e., private) intention attribution conditions, in sixty healthy aging individuals (30 males and 30 females). In half of the participants the anode was positioned over the mPFC, whereas in the other half the cathode was positioned over the mPFC. The results showed that: (i) anodal tDCS over the mPFC led to significant slower reaction times (vs. sham) for social intention attribution task only in female participants; (ii) No effects were found in both females and males during cathodal stimulation. We show for the first time sex-related differences in cognitive ToM abilities in healthy aging, extending previous findings concerning young participants.",2019,The results showed that: (i) anodal tDCS over the mPFC led to significant slower reaction times (vs. sham) for social intention attribution task only in female participants; (ii) No effects were found in both females and males during cathodal stimulation.,['sixty healthy aging individuals (30 males and 30 females'],"['sham tDCS session', 'cognitive ToM task, including both social (i.e., communicative) and nonsocial (i.e., private) intention attribution conditions', 'Transcranial direct current stimulation (tDCS']","['cognitive ToM abilities', 'reaction times', 'social intention attribution task']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",60.0,0.0376592,The results showed that: (i) anodal tDCS over the mPFC led to significant slower reaction times (vs. sham) for social intention attribution task only in female participants; (ii) No effects were found in both females and males during cathodal stimulation.,"[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Adenzato', 'Affiliation': 'Department of Psychology, University of Turin, Turin, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Manenti', 'Affiliation': 'Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gobbi', 'Affiliation': 'Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Enrici', 'Affiliation': 'Department of Philosophy and Educational Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Danila', 'Initials': 'D', 'LastName': 'Rusich', 'Affiliation': 'Department of Human Science, LUMSA University, Roma, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cotelli', 'Affiliation': 'Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy. mcotelli@fatebenefratelli.eu.'}]",Scientific reports,['10.1038/s41598-019-54469-4']
1341,31218713,Inhalation Aerosol Therapy in the Treatment of Chronic Rhinosinusitis: A Prospective Randomized Study.,"The purpose of the study was to compare treatment of chronic rhinosinusitis (CRS) with topical glucocorticoids and saline irrigation versus aerosol inhalation therapy. Patients diagnosed with CRS were randomly divided into 2 groups. In the first group, patients were treated with topical glucocorticoids (mometasone furoate, 100 µg in each nostril once daily) and saline irrigation (150 mL twice a day) for 2 weeks. In the second group, patients were treated with inhalation aerosol therapy composed of essential oils, saline, glucocorticoids, and antibiotics, once daily 5 times per week (Monday through Friday), for 2 weeks. The effect of the treatments was compared between the 2 groups. In the first group there was no significant improvement in the Glasgow Health Status Inventory (GHSI) (P = .29). In the second group the improvement in GHSI score was significant (P = .037). It was shown that in the first group the Glasgow Benefit Inventory score was significantly lower than in the second group (P = .002), which means that the improvement in the health status after the therapy was better in the second group. A Lund-Kennedy score showed statistical improvement in both groups (both P < .001). Improvement was also compared between the groups. The results were not significant (P = .11). The authors concluded that, in this preliminary research, inhalation aerosol therapy composed of essential oils, saline, glucocorticoids, and antibiotics led to better subjective results than intranasal glucocorticoid therapy and saline irrigation in the treatment of CRS. Further investigations with more participants, longer periods of treatment, and different validation tools are needed to confirm our results.",2019,In the first group there was no significant improvement in the Glasgow Health Status Inventory (GHSI) (P = .29).,"['Chronic Rhinosinusitis', 'Patients diagnosed with CRS', 'chronic rhinosinusitis (CRS']","['topical glucocorticoids and saline irrigation versus aerosol inhalation therapy', 'topical glucocorticoids (mometasone furoate', 'Inhalation Aerosol Therapy', 'inhalation aerosol therapy composed of essential oils, saline, glucocorticoids, and antibiotics', 'intranasal glucocorticoid therapy and saline irrigation', 'saline irrigation']","['health status', 'Glasgow Health Status Inventory (GHSI', 'Glasgow Benefit Inventory score', 'GHSI score']","[{'cui': 'C0149516', 'cui_str': 'Chronic sinusitis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0001712', 'cui_str': 'Aerosol (substance)'}, {'cui': 'C0021459', 'cui_str': 'Inhalation Therapy'}, {'cui': 'C0066700', 'cui_str': 'mometasone furoate'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C3714568', 'cui_str': 'Aerosol therapy (procedure)'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0131279,In the first group there was no significant improvement in the Glasgow Health Status Inventory (GHSI) (P = .29).,"[{'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Velepič', 'Affiliation': 'Clinic of Otorhinolaryngology Head and Neck Surgery, Clinical Medical Centre, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Dubravko', 'Initials': 'D', 'LastName': 'Manestar', 'Affiliation': 'Faculty of Medicine, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Ivona', 'Initials': 'I', 'LastName': 'Perković', 'Affiliation': 'Clinic of Otorhinolaryngology Head and Neck Surgery, Clinical Medical Centre, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Škalamera', 'Affiliation': 'Clinic of Otorhinolaryngology Head and Neck Surgery, Clinical Medical Centre, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Braut', 'Affiliation': 'Clinic of Otorhinolaryngology Head and Neck Surgery, Clinical Medical Centre, University of Rijeka, Rijeka, Croatia.'}]",Journal of clinical pharmacology,['10.1002/jcph.1471']
1342,31215837,Randomized Trial to Reduce Cardiovascular Risk in Women with Recent Preeclampsia.,"Background:  To reduce cardiovascular disease (CVD) risk, we tested an online intervention to improve healthy lifestyle for women with recent preeclampsia.  Materials and Methods:  We conducted a randomized controlled 9-month clinical trial, Heart Health 4 Moms (HH4M), among 151 U.S. women with preeclampsia within 5 years. Sample size was planned to detect differences of 0.5 standard deviation units in primary outcomes between study arms. Preeclampsia history was validated by medical records; women with chronic hypertension were excluded. The intervention included online educational modules, a community forum, and communication with a lifestyle coach. The control group received internet links to CVD risk reduction information. Primary outcomes were self-efficacy to eat a healthy diet and increase physical activity; change in physical in/activity; adherence to the Dietary Approaches to Stop Hypertension (DASH) diet; and knowledge of and personal control over CVD risk. Secondary outcomes were weight and blood pressure.  Results:  In the intervention arm, 84% of participants accessed at least one online educational module; 89% completed at least three scheduled calls with the coach. At 9 months, intervention participants reported significantly greater knowledge of CVD risk factors (corrected  p  = 0.01), increased self-efficacy for healthy eating ( p  = 0.03), and less physical inactivity than controls ( p  = 0.0006). The groups did not differ in sense of personal control of CVD risk factors, adherence to the DASH diet, self-efficacy for physical activity, or reported physical activity. There were no differences in secondary outcomes between groups.  Conclusions:  The HH4M program improved CVD risk knowledge, self-efficacy to achieve a healthy diet, and reduced physical inactivity among women with recent preeclampsia.",2019,"At 9 months, intervention participants reported significantly greater knowledge of CVD risk factors (corrected  p  = 0.01), increased self-efficacy for healthy eating ( p  = 0.03), and less physical inactivity than controls ( p  = 0.0006).","['Heart Health 4 Moms (HH4M), among 151 U.S. women with preeclampsia within 5 years', 'women with recent preeclampsia', 'Preeclampsia history was validated by medical records; women with chronic hypertension were excluded', 'Women with Recent Preeclampsia']","['online educational modules, a community forum, and communication with a lifestyle coach', 'internet links to CVD risk reduction information']","['self-efficacy to eat a healthy diet and increase physical activity; change in physical in/activity; adherence to the Dietary Approaches to Stop Hypertension (DASH) diet; and knowledge of and personal control over CVD risk', 'personal control of CVD risk factors, adherence to the DASH diet, self-efficacy for physical activity, or reported physical activity', 'weight and blood pressure', 'CVD risk knowledge, self-efficacy', 'physical inactivity', 'self-efficacy for healthy eating', 'knowledge of CVD risk factors']","[{'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",151.0,0.100584,"At 9 months, intervention participants reported significantly greater knowledge of CVD risk factors (corrected  p  = 0.01), increased self-efficacy for healthy eating ( p  = 0.03), and less physical inactivity than controls ( p  = 0.0006).","[{'ForeName': 'Janet W', 'Initials': 'JW', 'LastName': 'Rich-Edwards', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Stuart', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Skurnik', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Andrea T', 'Initials': 'AT', 'LastName': 'Roche', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Tsigas', 'Affiliation': 'Preeclampsia Foundation, Melbourne, Florida.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Fitzmaurice', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Louise E', 'Initials': 'LE', 'LastName': 'Wilkins-Haug', 'Affiliation': ""Department of Obstetrics, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Levkoff', 'Affiliation': 'College of Social Work, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Ellen W', 'Initials': 'EW', 'LastName': 'Seely', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",Journal of women's health (2002),['10.1089/jwh.2018.7523']
1343,31194160,Factors affecting the dose of intervention received and the participant satisfaction in a school-based obesity prevention intervention.,This study assessed factors associated with the perceived dose of intervention received and with the participant satisfaction in a school-based obesity prevention intervention. It also explored the variance in the dose of intervention received that was at the school level. Process evaluation data from a school-based intervention study conducted in Oslo in 2007-2009 were used. A total of 542 11-year-olds from 12 intervention schools were included. A web-based questionnaire was used to collect data. Descriptive analyses and multilevel regression analyses were conducted. Females and those with medium (vs. low) parental education had higher odds of reporting a high vs. low dose of intervention received at mid-way (8 months after baseline). Perceived social capital and perceived social support for physical activity from friends at baseline were positively associated with the dose of intervention received at mid-way. Perceived social capital at mid-way was positively associated with the dose of intervention reported post-intervention (20 months after baseline). Around 20% of the variance in the perceived dose of intervention received was at the school level. Satisfaction with the intervention was high overall and higher for females for several intervention components at mid-way and at post-intervention. The factors identified in this study should be taken into consideration when planning future obesity prevention interventions among youth.,2019,Perceived social capital and perceived social support for physical activity from friends at baseline were positively associated with the dose of intervention received at mid-way.,"['A total of 542 11-year-olds from 12 intervention schools were included', 'school-based intervention study conducted in Oslo in 2007-2009 were used']",['school-based obesity prevention intervention'],"['Perceived social capital', 'Perceived social capital and perceived social support for physical activity']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C1510639', 'cui_str': 'Social Capital'}, {'cui': 'C0037438'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0188606,Perceived social capital and perceived social support for physical activity from friends at baseline were positively associated with the dose of intervention received at mid-way.,"[{'ForeName': 'Mekdes K', 'Initials': 'MK', 'LastName': 'Gebremariam', 'Affiliation': 'Department of Epidemiology, Fielding School of Public Health, University of California, Los Angeles (UCLA), Los Angeles, CA, United States.'}, {'ForeName': 'Onyebuchi A', 'Initials': 'OA', 'LastName': 'Arah', 'Affiliation': 'Department of Epidemiology, Fielding School of Public Health, University of California, Los Angeles (UCLA), Los Angeles, CA, United States.'}, {'ForeName': 'Ingunn H', 'Initials': 'IH', 'LastName': 'Bergh', 'Affiliation': 'Department of Health and Inequality, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Lene F', 'Initials': 'LF', 'LastName': 'Andersen', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Bjelland', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Grydeland', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Lien', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, University of Oslo, Oslo, Norway.'}]",Preventive medicine reports,['10.1016/j.pmedr.2019.100906']
1344,31151800,"Immunogenicity and safety of a novel recombinant protective antigen anthrax vaccine (GC1109), a randomized, single-blind, placebo controlled phase II clinical study.","BACKGROUND


The demand on effective and safe anthrax vaccine is increasing as a part of the preparedness for possible bioterrorism in the future. We performed a randomized, single-blind, placebo controlled phase II clinical study to evaluate the immunogenicity and safety of a novel recombinant protective antigen (rPA) anthrax vaccine, GC1109, in healthy adult volunteers.
METHODS


Participants were randomized to experiment groups (0.3 mL, 0.5 mL, and 1.0 mL of GC1109) or placebo group (normal saline 0.5 mL) in 2:2:2:1 ratio. They received respective vaccines intramuscularly at 0, 4 and 8 weeks. Immunogenicity was evaluated by seroconversion rate and geometric mean titer (GMT) of lethal toxin neutralizing assay (TNA) and anti-PA IgG by ELISA. Safety was assessed by laboratory tests, and solicited and unsolicited adverse events on diary cards.
RESULTS


30, 29, 30 participants were randomized to 0.3, 0.5, and 1.0 mL of GC1109 groups, respectively, while 15 to placebo group. 92 participants received all three doses. In per-protocol analysis, TNA GMTs at week 12 were 296.5, 285.2, and 433.2 in the three groups, respectively. Seroconversion rates measured by ELISA were 100% at week 12 in the three groups. Local and systemic vaccine-related adverse events were frequent; however, most of them were mild, and no serious events were observed.
CONCLUSIONS


A new rPA anthrax vaccine GC1109 was immunogenic after three doses of intramuscular administration, and was well-tolerated.",2019,"Local and systemic vaccine-related adverse events were frequent; however, most of them were mild, and no serious events were observed.
","['92 participants', 'Participants', '30, 29, 30 participants', 'healthy adult volunteers']","['novel recombinant protective antigen (rPA) anthrax vaccine, GC1109', 'placebo', 'novel recombinant protective antigen anthrax vaccine (GC1109']","['seroconversion rate and geometric mean titer (GMT) of lethal toxin neutralizing assay (TNA) and anti-PA IgG by ELISA', 'Seroconversion rates', 'immunogenicity and safety', 'laboratory tests, and solicited and unsolicited adverse events on diary cards', 'Immunogenicity', 'Immunogenicity and safety']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1443846', 'cui_str': 'Protective antigen'}, {'cui': 'C0358297', 'cui_str': 'Anthrax Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C1443966', 'cui_str': 'Anthrax toxin lethal toxin'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",30.0,0.222222,"Local and systemic vaccine-related adverse events were frequent; however, most of them were mild, and no serious events were observed.
","[{'ForeName': 'Chang Kyung', 'Initials': 'CK', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Nak-Hyun', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Chung-Jong', 'Initials': 'CJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Gi-Eun', 'Initials': 'GE', 'LastName': 'Rhie', 'Affiliation': 'Division of High-risk Pathogens, Center for Laboratory Control of Infectious Diseases, Korea Centers for Disease Control and Prevention, Chungju, Republic of Korea.'}, {'ForeName': 'Su Kyoung', 'Initials': 'SK', 'LastName': 'Jo', 'Affiliation': 'Division of High-risk Pathogens, Center for Laboratory Control of Infectious Diseases, Korea Centers for Disease Control and Prevention, Chungju, Republic of Korea.'}, {'ForeName': 'Misun', 'Initials': 'M', 'LastName': 'Ahn', 'Affiliation': 'GC Pharma Central Research Center, Yongin, Republic of Korea.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'GC Pharma Central Research Center, Yongin, Republic of Korea.'}, {'ForeName': 'Pyoeng Gyun', 'Initials': 'PG', 'LastName': 'Choe', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Wan Beom', 'Initials': 'WB', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Nam-Joong', 'Initials': 'NJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: mdohmd@snu.ac.kr.'}]",Vaccine,['10.1016/j.vaccine.2019.05.057']
1345,31700635,Over-the-scope clips are cost-effective in recurrent peptic ulcer bleeding.,"Background


A recent prospective randomised controlled trial ('STING') showed superiority of over-the-scope clips compared to standard treatment in recurrent peptic ulcer bleeding. Cost-effectiveness studies on haemostasis with over-the-scope clips have not been reported so far.
Objective


The aim of this study was to investigate whether the higher efficacy of the over-the-scope clips treatment outweighs the higher costs of the device compared to standard clips.
Methods


For the analysis, the study population of the STING trial was used. Costs for the hospital stay in total as well as treatment-related costs were obtained. The average cost-effectiveness ratio, representing the mean costs per designated outcome, and the incremental cost-effectiveness ratio, expressing the additional costs of a new treatment strategy per difference in outcome were calculated. The designated outcome was defined as successful haemostasis without rebleeding within seven days, which was the primary endpoint of the STING trial. Average cost-effectiveness ratio and incremental cost-effectiveness ratio were calculated for total costs of the hospital stay as well as the haemostasis treatment alone. The cost-effectiveness analysis is taken from the perspective of the care provider. Results:  Total costs and treatment-related costs per patient were 13,007.07 € in the standard group vs 12,808.56 € in the over-the-scope clip group ( p  = 0.812) and 2084.98 € vs 1984.71 € respectively ( p  = 0.663). The difference was not statistically significant. Total costs per successful haemostasis (average cost-effectiveness ratio) were 30,677.05 € vs 15,104.43 € and 4917.41 € vs 2340.46 € for the haemostasis treatment. The additional costs per successful haemostasis with over-the-scope clip treatment (incremental cost-effectiveness ratio) is -468.18 € for the whole treatment and -236.49€ for the haemostasis treatment.
Conclusions


Over-the-scope clip treatment is cost-effective in recurrent peptic ulcer bleeding.",2019,"Total costs per successful haemostasis (average cost-effectiveness ratio) were 30,677.05 € vs 15,104.43 € and 4917.41 € vs 2340.46 € for the haemostasis treatment.",['recurrent peptic ulcer bleeding'],[],"['incremental cost-effectiveness ratio', 'successful haemostasis without rebleeding', 'Total costs and treatment-related costs per patient', 'average cost-effectiveness ratio', 'total costs of the hospital stay', 'Average cost-effectiveness ratio and incremental cost-effectiveness ratio', 'Total costs per successful haemostasis (average cost-effectiveness ratio']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0030920', 'cui_str': 'Gastroduodenal Ulcer'}]",[],"[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0551777,"Total costs per successful haemostasis (average cost-effectiveness ratio) were 30,677.05 € vs 15,104.43 € and 4917.41 € vs 2340.46 € for the haemostasis treatment.","[{'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Kuellmer', 'Affiliation': 'Department of Medicine II, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Behn', 'Affiliation': 'Department of Gastroenterology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Meier', 'Affiliation': 'Department of Gastroenterology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wannhoff', 'Affiliation': 'Department of Gastroenterology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Bettinger', 'Affiliation': 'Department of Medicine II, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Thimme', 'Affiliation': 'Department of Medicine II, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Caca', 'Affiliation': 'Department of Gastroenterology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Department of Medicine II, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}]",United European gastroenterology journal,['10.1177/2050640619871754']
1346,31781699,Immediate versus conventional loading of variable-thread tapered implants supporting three- to four-unit fixed partial dentures in the posterior maxilla: 3-year results of a split-mouth randomised controlled trial.,"PURPOSE


To compare the 3-year outcomes of immediately loaded and one-stage conventionally loaded variable-thread tapered implants in the posterior maxilla.
MATERIALS AND METHODS


This study was designed as a split-mouth randomised controlled trial. Twenty-six patients attending the postgraduate Periodontics Department at the Lebanese University, and missing teeth bilaterally in the posterior maxilla were randomised. All patients received three to four implants in each of the posterior sextants. The implants on one side were immediately loaded with a provisional resin fixed partial denture on definitive multi-unit abutments regardless of their primary stability. The implants in the contralateral side received definitive multi-unit abutments according to the one-stage unloaded protocol. Three to 3.5 months following implant placement, the implants were restored with metal-ceramic fixed prostheses. Outcome measures were implant and prosthesis failure rates, complications, and peri-implant bone level changes up to 3 years following delivery of the definitive prosthesis. The clinical outcomes and radiographic measurements were performed by a single outcome assessor blinded to the type of interventions.
RESULTS


Two patients dropped out prior to the delivery of definitive prostheses. The results were analysed using a per-protocol analysis and included 24 patients. Four implants supporting a four-unit immediately loaded prosthesis failed in one patient, 3 months following definitive prosthesis. In the same patient, the three contralateral conventionally loaded implants failed 14 months after definitive prosthesis. There were no significant differences in the proportions of implant and prosthesis failures at 3 years (difference = 0%; 95% CI 0.0% to 14.2%; P = 0.999). Peri-implantitis was diagnosed at two adjacent conventionally loaded implants in one patient at the 3-year examination. In the immediately loaded group, four early minor prosthetic complications occurred during the provisionalisation phase. Following delivery of the definitive prostheses, one minor ceramic fracture was observed in each of the implant groups. The difference in the rate of complications between the two interventions was not statistically significant at 3 years (difference = 13%; 95% CI 3.4% to 27.7%; P = 0.453). The 3-year peri-implant marginal bone level changes were evaluated in 23 patients (77 immediately loaded and 76 conventionally loaded implants). On average, patients lost 0.79 (0.62) mm at the immediately loaded and 0.91 (0.82) mm at the conventionally loaded implants, the difference being statistically not significant (difference = 0.12 mm; 95% CI -0.31 to 0.55 mm; P = 0.590). The 3-year marginal bone level changes were not significantly different between smokers (n = 12) and non-smokers (n = 11) (difference = 0.19 mm; 95% CI -0.24 to 0.62 mm; P = 0.382).
CONCLUSIONS


Immediate loading of three- to four-unit fixed partial prostheses supported by variable-thread implants in the posterior maxilla can achieve similar 3-year results to one-stage conventionally loaded implants.",2019,"The 3-year marginal bone level changes were not significantly different between smokers (n = 12) and non-smokers (n = 11) (difference = 0.19 mm; 95% CI -0.24 to 0.62 mm; P = 0.382).
","['Twenty-six patients attending the postgraduate Periodontics Department at the Lebanese University, and missing teeth bilaterally in the posterior maxilla were randomised', '23 patients (77 immediately loaded and 76 conventionally loaded implants']","['conventional loading of variable-thread tapered implants supporting three- to four-unit fixed partial dentures', 'immediately loaded and one-stage conventionally loaded variable-thread tapered implants']","['3-year peri-implant marginal bone level changes', 'implant and prosthesis failure rates, complications, and peri-implant bone level changes up to 3 years following delivery of the definitive prosthesis', 'prosthetic complications', 'rate of complications', '3-year marginal bone level changes', 'proportions of implant and prosthesis failures']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0031098', 'cui_str': 'Periodontal Medicine'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0011461', 'cui_str': 'Fixed Bridge'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0524929', 'cui_str': 'Prosthetic Implants'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]",77.0,0.162808,"The 3-year marginal bone level changes were not significantly different between smokers (n = 12) and non-smokers (n = 11) (difference = 0.19 mm; 95% CI -0.24 to 0.62 mm; P = 0.382).
","[{'ForeName': 'Fadi I', 'Initials': 'FI', 'LastName': 'Daher', 'Affiliation': ''}, {'ForeName': 'Habib L', 'Initials': 'HL', 'LastName': 'Abi-Aad', 'Affiliation': ''}, {'ForeName': 'Hani I', 'Initials': 'HI', 'LastName': 'Dimassi', 'Affiliation': ''}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Cordioli', 'Affiliation': ''}, {'ForeName': 'Zeina A K', 'Initials': 'ZAK', 'LastName': 'Majzoub', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1347,30831344,Impact of a social skills program on children's stress: A cluster randomized trial.,"BACKGROUND


Most preschool children in Western industrialized countries attend child care during the day while parents work. Studies suggest that child care may be stressful to young children, perhaps because they still lack the social skills to interact daily in a group setting away from parents. This gap in social abilities may be greater for children in lower-income families, who may face more adversity at home, with fewer resources and more social isolation.
METHODS


We conducted a cluster-randomized controlled trial in 2013-2014 to test whether a social skills intervention led by early childhood educators within the child care center could reduce diurnal cortisol levels to more typical patterns expected of children this age. We randomized 19 public child care centers (n = 361 children) in low-income neighborhoods of Montreal, Canada, to either: 1) the Minipally program - intervention group (n = 10 centers; 186 children), or 2) waiting list - control group (n = 9 centers; 175 children). Saliva samples for cortisol levels were collected 3 times/day, pre- and post-implementation. The Minipally puppet program consists of 2 workshops/month for 8 months for the development of social skills and self-regulation in 2-5-year-olds, with reinforcement activities between workshops. Educators received 2-days' training and 12 h' supervision in Minipally.
RESULTS


Linear mixed models for repeated measures revealed a significant interaction between intervention status and time of day of cortisol sampling (β = -0.18, p =  0.04). The intervention group showed patterns of decreasing diurnal cortisol secretion (β = -0.32, p < 0.01), whereas the control group showed increasing slopes (β = 0.20, p < 0.01). Moreover, family income was a moderator; children in lower-income families benefited most from the intervention.
CONCLUSION


Results suggest that a social skills training program, when integrated into a preschool education curriculum, can foster an environment more conducive to typical childhood patterns of cortisol secretion.",2019,"The intervention group showed patterns of decreasing diurnal cortisol secretion (β = -0.32, p < 0.01), whereas the control group showed increasing slopes (β = 0.20, p < 0.01).","[""children's stress"", '19 public child care centers (n\u2009=\u2009361 children) in low-income neighborhoods of Montreal, Canada, to either: 1) the Minipally program - intervention group (n\u2009=\u200910 centers; 186 children), or 2) waiting list - control group (n\u2009=\u20099 centers; 175 children']","['social skills program', 'social skills intervention', ""2-days' training and 12\u2009h' supervision in Minipally""]","['diurnal cortisol levels', 'Saliva samples for cortisol levels', 'diurnal cortisol secretion', 'intervention status and time of day of cortisol sampling']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439548', 'cui_str': 'Temporal periods of day (qualifier value)'}]",19.0,0.0395461,"The intervention group showed patterns of decreasing diurnal cortisol secretion (β = -0.32, p < 0.01), whereas the control group showed increasing slopes (β = 0.20, p < 0.01).","[{'ForeName': 'Marie-Pier', 'Initials': 'MP', 'LastName': 'Larose', 'Affiliation': 'University of Montreal, Canada. Electronic address: marie-pier.larose.1@umontreal.ca.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ouellet-Morin', 'Affiliation': 'University of Montreal, Canada; Research Centre, Montreal Mental Health University Institute (Institut universitaire de santé mentale de Montréal), Canada. Electronic address: isabelle.ouellet-morin@umontreal.ca.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Vitaro', 'Affiliation': 'University of Montreal, Canada. Electronic address: frank.vitaro@umontreal.ca.'}, {'ForeName': 'Marie Claude', 'Initials': 'MC', 'LastName': 'Geoffroy', 'Affiliation': 'McGill University, Montreal, Canada. Electronic address: marie-claude.geoffroy@mcgill.ca.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Ahun', 'Affiliation': 'University of Montreal, Canada. Electronic address: marilyn.ahun@umontreal.ca.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Tremblay', 'Affiliation': 'University of Montreal, Canada. Electronic address: richard.ernest.tremblay@umontreal.ca.'}, {'ForeName': 'Sylvana M', 'Initials': 'SM', 'LastName': 'Côté', 'Affiliation': 'University of Montreal, Canada; University of Bordeaux, INSERM U1219, Bordeaux, France. Electronic address: sylvana.cote.1@umontreal.ca.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.02.017']
1348,30852278,The SMART Moms Program: A Randomized Trial of the Impact of Stress Management on Perceived Stress and Cortisol in Low-Income Pregnant Women.,"BACKGROUND


Dysregulations in maternal hypothalamus-pituitary-adrenal function and the end product, cortisol, have been associated with a heightened risk for stress-related health complications during pregnancy and post partum. Given the adverse health impact that maternal cortisol may have on expectant mothers and their infants, empirically-based prenatal interventions are needed to target optimal management of stress and its biological effects in at-risk pregnant women, a primary example of which is cognitive behavioral stress management (CBSM). This randomized-controlled trial examined the effects of a prenatal CBSM intervention on reduction in perceived stress and regulation of salivary cortisol patterns [i.e., overall cortisol output (area under the curve), cortisol awakening response (CAR), diurnal slope] during pregnancy and the early postpartum period, as compared to a control group.
METHODS


One hundred low-income pregnant women (71% Latina; 76% annual income < $20 K) with low or high anxiety during pregnancy were randomized (stratified by anxiety) to either an eight-week CBSM group intervention (n = 55) or a control group (n = 45). They provided seven salivary cortisol samples (four am samples, 12 pm, 4 pm, and 8 pm samples on one collection day) at baseline (1 st  trimester; < 17 weeks of gestation), after their prenatal program (2 nd  trimester), and also in the third trimester and at three months post partum.
RESULTS


Women receiving CBSM had lower perceived stress levels throughout pregnancy and early post partum compared to women in the control group (p = .020). Among women with high prenatal anxiety, those in CBSM showed a steeper decline in their diurnal cortisol at three months post partum compared to those in the control group (p = .015). Further, non-Latina women in CBSM had a lower CAR at three months post partum compared to non-Latina women in the control group (p = .025); these randomization group differences on the CAR were not observed among Latina women.
CONCLUSIONS


These findings provide preliminary support for the efficacy of prenatal CBSM interventions in improving stress outcomes among low-income pregnant women and suggest the need to test the effects of these interventions on a larger scale for improving maternal and infant health outcomes long-term.",2019,"RESULTS


Women receiving CBSM had lower perceived stress levels throughout pregnancy and early post partum compared to women in the control group (p = .020).","['low-income pregnant women', 'One hundred low-income pregnant women (71% Latina; 76% annual income < $20\u2009K) with low or high anxiety during pregnancy', 'Low-Income Pregnant Women']","['prenatal CBSM interventions', 'Stress Management', 'prenatal CBSM intervention', 'CBSM group intervention', 'CBSM']","['perceived stress and regulation of salivary cortisol patterns [i.e., overall cortisol output (area under the curve), cortisol awakening response (CAR), diurnal slope', 'stress levels', 'CAR', 'diurnal cortisol']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0004381', 'cui_str': 'Automobiles'}]",100.0,0.0412507,"RESULTS


Women receiving CBSM had lower perceived stress levels throughout pregnancy and early post partum compared to women in the control group (p = .020).","[{'ForeName': 'Guido G', 'Initials': 'GG', 'LastName': 'Urizar', 'Affiliation': 'Department of Psychology, California State University, Long Beach, 1250 Bellflower Blvd., Long Beach, CA 90840-0901, USA. Electronic address: guido.urizar@csulb.edu.'}, {'ForeName': 'Ilona S', 'Initials': 'IS', 'LastName': 'Yim', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, 4562 Social and Behavioral Sciences Gateway, Irvine, CA 92697-7085, USA. Electronic address: ilona.yim@uci.edu.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, 1285 Franz Hall, Los Angeles, CA 90095-1563, USA. Electronic address: anthonyr@rand.org.'}, {'ForeName': 'Christine Dunkel', 'Initials': 'CD', 'LastName': 'Schetter', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, 1285 Franz Hall, Los Angeles, CA 90095-1563, USA. Electronic address: dunkel@psych.ucla.edu.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.02.022']
1349,31773110,Effectiveness of Accelerated Recovery Performance for Post-ACL Reconstruction Rehabilitation.,"Atrophy and protracted recovery of normal function of the ipsilateral quadriceps femoris muscle following anterior cruciate ligament reconstruction surgery is well documented. The Accelerated Recovery Performance trainer is a type of electrical stimulation device that delivers a high-pulse frequency via a direct current, making it unique from many other devices on the market. The purpose of the present study was to investigate the effects of the direct current (via the Accelerated Recovery Performance trainer protocol) on gains in thigh circumference following anterior cruciate ligament reconstruction. Twenty-five patients were enrolled following isolated anterior cruciate ligament reconstruction and randomly assigned to either an isometric rehabilitation protocol augmented with the Accelerated Recovery Performance trainer protocol (experimental group) or the isometric rehabilitation protocol alone (control group). The two groups participated in sixteen sessions of directed rehabilitation over a two-month time period. Patients were followed with serial thigh circumference measurements at 5, 10, 15, and 20 centimeters above the superior patellar pole. Comparison of the overall mean circumferential gains in thigh circumference of the involved leg demonstrated approximately 3:1 gains in the ARP group over the control group, demonstrating it to be superior to isometric rehabilitation alone with regards to gains in thigh girth. The Accelerated Recovery Performance trainer protocol should be considered for post-anterior cruciate ligament reconstruction rehabilitation in order to reverse disuse atrophy of the ipsilateral quadriceps femoris.",2019,Twenty-five patients were enrolled following isolated anterior cruciate ligament reconstruction and randomly assigned to either an isometric rehabilitation protocol augmented with the Accelerated Recovery Performance trainer protocol (experimental group) or the isometric rehabilitation protocol alone (control group).,"['anterior cruciate ligament reconstruction surgery', 'anterior cruciate ligament reconstruction', 'Twenty-five patients were enrolled following isolated anterior cruciate ligament reconstruction']","['isometric rehabilitation protocol augmented with the Accelerated Recovery Performance trainer protocol (experimental group) or the isometric rehabilitation protocol alone (control group', 'direct current (via the Accelerated Recovery Performance trainer protocol']",['gains in thigh circumference'],"[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442831', 'cui_str': 'Direct current (physical force)'}]","[{'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}]",25.0,0.0163297,Twenty-five patients were enrolled following isolated anterior cruciate ligament reconstruction and randomly assigned to either an isometric rehabilitation protocol augmented with the Accelerated Recovery Performance trainer protocol (experimental group) or the isometric rehabilitation protocol alone (control group).,"[{'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Wright', 'Affiliation': 'Division of Orthopaedic Surgery, John A. Burns School of Medicine, University of Hawai7#x2018;i, Honolulu, HI.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Richardson', 'Affiliation': 'Division of Orthopaedic Surgery, John A. Burns School of Medicine, University of Hawai7#x2018;i, Honolulu, HI.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kikuchi', 'Affiliation': 'Division of Orthopaedic Surgery, John A. Burns School of Medicine, University of Hawai7#x2018;i, Honolulu, HI.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Goldberg', 'Affiliation': 'Division of Orthopaedic Surgery, John A. Burns School of Medicine, University of Hawai7#x2018;i, Honolulu, HI.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Marumoto', 'Affiliation': 'Division of Orthopaedic Surgery, John A. Burns School of Medicine, University of Hawai7#x2018;i, Honolulu, HI.'}, {'ForeName': 'Darryl M', 'Initials': 'DM', 'LastName': 'Kan', 'Affiliation': 'Division of Orthopaedic Surgery, John A. Burns School of Medicine, University of Hawai7#x2018;i, Honolulu, HI.'}]",Hawai'i journal of health & social welfare,[]
1350,31782930,Cardiorespiratory fitness and muscular endurance responses immediately and 2 months after a whole-body Tabata or vigorous-intensity continuous training intervention.,"Young adults (52 females, 16 males; age = 21 ± 3 years;  V̇ O 2peak : 41 ± 6 mL/(kg·min)) were randomized into 3 groups: ( i ) no-exercise control (CTL;  n  = 15), ( ii ) Tabata ( n  = 27), or ( iii ) vigorous-intensity continuous training (VICT;  n  = 26) groups for a 4-week supervised training period (4 sessions/week).  V̇ O 2peak , time-to-fatigue (TTF), 5 km time-trial performance (TT), and muscular endurance were assessed at baseline, post-training (POST), and 2-month follow-up (FU). Response confidence intervals (CI) were used to classify individuals as likely responders (R; CI > 0). Both exercise interventions increased TTF and TT at POST (both  p  < 0.01), but these benefits were maintained at FU after VICT only ( p  < 0.01). Push-up performance was increased at POST and FU (both  p  < 0.01) after Tabata. VICT resulted in a greater proportion of TTF R versus both groups at POST (CTL: 1/15; VICT: 19/26; Tabata: 9/27) and versus Tabata at FU (3/15; 13/26; 4/27). VICT also had a greater proportion of TT R versus CTL at POST (2/15; 17/26; 10/27). Tabata had a greater proportion of R for maximum push-up repetitions versus both groups at POST (3/15; 6/26; 18/27) and versus CTL at FU (2/15; 10/26; 18/27). Collectively, VICT appears to be more effective for improving cardiorespiratory fitness, whereas whole-body Tabata confers larger improvements in push-up performance following short-term training.  Novelty:  Vigorous-intensity continuous training elicits larger improvements in cardiorespiratory fitness versus whole-body Tabata. Individual response profiles parallel group-level changes in cardiorespiratory fitness and muscular endurance.",2019,Push-up performance was increased at POST and FU (both p<0.01) after Tabata.,"['Young adults (n=68 [52 F]; age=21±3 y; VO2peak: 41±6 mL/kg/min', 'n=15), Tabata (n=26), or']","['vigorous-intensity continuous training (VICT; n=27) group for a four-week supervised training period', 'VICT', 'whole-body Tabata or vigorous-intensity continuous training intervention', 'no-exercise control (CTL']","['Cardiorespiratory fitness and muscular endurance responses', 'proportion of TTF R', 'cardiorespiratory fitness and muscular endurance', 'Response confidence intervals (CI', 'cardiorespiratory fitness', 'VO2peak, time-to-fatigue (TTF), 5 km time-trial performance (TT), and muscular endurance', 'TTF and TT at POST', 'Novelty bullets']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0336699', 'cui_str': 'Bullet, device (physical object)'}]",,0.0254434,Push-up performance was increased at POST and FU (both p<0.01) after Tabata.,"[{'ForeName': 'Hashim', 'Initials': 'H', 'LastName': 'Islam', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Siemens', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Jennifer B L', 'Initials': 'JBL', 'LastName': 'Matusiak', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sawula', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Bonafiglia', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Preobrazenski', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Jung', 'Affiliation': 'School of Health and Exercise Sciences, The University of British Columbia Okanagan, 1147 Research Road, Kelowna, BC V1V 1V7, Canada.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Gurd', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, 28 Division Street, Kingston, ON K7L 3N6, Canada.""}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0492']
1351,31034255,Patient-oriented education and visual-aid intervention are inadequate to identify patients with potential capsule retention: a prospective randomized study.,"Background/aims:  The key procedure-related risk with video capsule endoscopy (VCE) is capsule retention, which should be suspected in patients who have not reported capsule passage. The study aims were to determine the frequency of capsule passage visualization and the difference in self-reporting of capsule passage between patients who receive patient-oriented education (POE) and patients who receive POE and a visual aid intervention in the form of a wrist band (WB).  Methods:  This was a prospective randomized study that enrolled patients undergoing VCE. Patients were randomly assigned to a POE group versus a POE and WB group. POE consisted of verbal education and an information booklet. Both groups received instructions to notify the study team regarding capsule passage.  Results:  Sixty patients (mean age 57 ± 18 years; 61% female) were included. A total of 57 patients were included in the analysis (3 lost to follow-up; 28 in POE group; 29 in WB group). Capsule passage status was reported by 68% without significant difference between POE and WB groups (72% vs. 64%;  p  = .51). Capsule passage status was obtained from all 57 patients with the addition of a proactive follow-up. Only 56% ( n  = 32) reported visualizing capsule passage. Of the remaining patients who did not visualize capsule passage, 60% ( n  = 15) reported on this without significant difference between the POE and WB groups ( p  = .23).  Conclusions:  Lack of visualization of capsule passage is a poor indicator of retention. Self-reporting of VCE passage status is suboptimal and the addition of a visual aid did not improve this parameter.",2019,Capsule passage status was reported by 68% without significant difference between POE and WB groups (72% vs. 64%;  p  = .51).,"['A total of 57 patients were included in the analysis (3 lost to follow-up; 28 in POE group; 29 in WB group', 'Sixty patients ', 'patients who have not reported capsule passage', 'patients who receive patient-oriented education (POE) and patients who receive POE and a visual aid intervention in the form of a wrist band (WB', 'patients with potential capsule retention', 'enrolled patients undergoing VCE', 'mean age 57\u2009±\u200918\xa0years; 61% female']","['POE and WB', 'POE', 'video capsule endoscopy (VCE', 'Patient-oriented education and visual-aid intervention']","['Capsule passage status', 'visualizing capsule passage']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0344218', 'cui_str': 'Visual aid (procedure)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1721048', 'cui_str': 'Video Capsule Endoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0344218', 'cui_str': 'Visual aid (procedure)'}]","[{'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",57.0,0.105243,Capsule passage status was reported by 68% without significant difference between POE and WB groups (72% vs. 64%;  p  = .51).,"[{'ForeName': 'Badr', 'Initials': 'B', 'LastName': 'Al-Bawardy', 'Affiliation': 'a Division of Gastroenterology and Hepatology , Mayo Clinic , Rochester , MN , USA.'}, {'ForeName': 'Amrit K', 'Initials': 'AK', 'LastName': 'Kamboj', 'Affiliation': 'b Department of Internal Medicine , Mayo Clinic , Rochester , MN , USA.'}, {'ForeName': 'Shiv', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'c Division of Gastroenterology and Hepatology , University of Pittsburgh Medical Center , Pittsburgh , PA , USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Gorospe', 'Affiliation': 'a Division of Gastroenterology and Hepatology , Mayo Clinic , Rochester , MN , USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Bruining', 'Affiliation': 'a Division of Gastroenterology and Hepatology , Mayo Clinic , Rochester , MN , USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Gostout', 'Affiliation': 'a Division of Gastroenterology and Hepatology , Mayo Clinic , Rochester , MN , USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Hansel', 'Affiliation': 'a Division of Gastroenterology and Hepatology , Mayo Clinic , Rochester , MN , USA.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Larson', 'Affiliation': 'a Division of Gastroenterology and Hepatology , Mayo Clinic , Rochester , MN , USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Murray', 'Affiliation': 'a Division of Gastroenterology and Hepatology , Mayo Clinic , Rochester , MN , USA.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Nehra', 'Affiliation': 'a Division of Gastroenterology and Hepatology , Mayo Clinic , Rochester , MN , USA.'}, {'ForeName': 'Cadman L', 'Initials': 'CL', 'LastName': 'Leggett', 'Affiliation': 'a Division of Gastroenterology and Hepatology , Mayo Clinic , Rochester , MN , USA.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Szarka', 'Affiliation': 'a Division of Gastroenterology and Hepatology , Mayo Clinic , Rochester , MN , USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Watson', 'Affiliation': 'd Department of Radiology , Mayo Clinic , Rochester , MN , USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rajan', 'Affiliation': 'a Division of Gastroenterology and Hepatology , Mayo Clinic , Rochester , MN , USA.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2019.1608465']
1352,30982761,The AAHKS Clinical Research Award: Prophylactic Tamsulosin Does Not Reduce the Risk of Urinary Retention Following Lower Extremity Arthroplasty: A Double-Blinded Randomized Controlled Trial.,"BACKGROUND


Postoperative urinary retention (POUR) is common. Selective alpha-1 adrenergic antagonists, such as tamsulosin, are effective for treating urinary retention. The purpose of this study is to determine whether perioperative prophylactic tamsulosin reduces the incidence of POUR following total hip and knee arthroplasty.
METHODS


Male patients 35 years of age and older undergoing primary total hip or knee arthroplasty at a single center from 2015 to 2018 were eligible for inclusion. Patients were randomized to receive tamsulosin 0.4 mg or placebo daily for 5 days preoperatively, the morning of surgery, and the first postoperative day. The incidence of POUR was determined during the postoperative hospitalization.
RESULTS


A total of 176 patients were enrolled in the study. Two patients were withdrawn prior to randomization. The remaining 174 were randomized to tamsulosin (n = 87) or placebo (n = 87). After an additional 43 patients were withdrawn prior to surgery, 131 patients completed the study (tamsulosin, n = 64; placebo, n = 67). A total of 42 patients (32.1%) developed POUR, with 18 cases (28.1%) in the tamsulosin group and 24 cases (35.8%) in the placebo group (P = .345), resulting in an odds ratio of 0.701 and a risk difference of 7.69%.
CONCLUSION


Prophylactic tamsulosin did not reduce the incidence of POUR after hip and knee arthroplasty compared to placebo. The odds ratio indicates an approximately 30% decreased odds of developing POUR in the tamsulosin group, albeit not statistically significant. Tamsulosin does not appear to be effective as a prophylactic measure for reducing POUR in male hip and knee arthroplasty patients.",2019,Tamsulosin does not appear to be effective as a prophylactic measure for reducing POUR in male hip and knee arthroplasty patients.,"['male hip and knee arthroplasty patients', 'Lower Extremity Arthroplasty', '43 patients were withdrawn prior to surgery, 131 patients completed the study (tamsulosin, n\xa0= 64', 'Male patients 35 years of age and older undergoing primary total hip or knee arthroplasty at a single center from 2015 to 2018 were eligible for inclusion', 'A total of 176 patients were enrolled in the study']","['placebo', 'Prophylactic tamsulosin', 'perioperative prophylactic tamsulosin', 'Tamsulosin', 'tamsulosin 0.4 mg or placebo', 'tamsulosin']","['incidence of POUR', 'POUR', 'odds of developing POUR']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}]",2.0,0.311242,Tamsulosin does not appear to be effective as a prophylactic measure for reducing POUR in male hip and knee arthroplasty patients.,"[{'ForeName': 'Manuel F', 'Initials': 'MF', 'LastName': 'Schubert', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Jared R', 'Initials': 'JR', 'LastName': 'Thomas', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI; IHA Orthopaedic Surgery Associates, Saint Joseph Mercy Health System, Ypsilanti, MI.'}, {'ForeName': 'Joel J', 'Initials': 'JJ', 'LastName': 'Gagnier', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Caitlin M', 'Initials': 'CM', 'LastName': 'McCarthy', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI; Department of Orthopaedic Surgery, Southern California Permanente Medical Group, Kaiser Permanente, Baldwin Park, CA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Urquhart', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Aidin Eslam', 'Initials': 'AE', 'LastName': 'Pour', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.03.039']
1353,30376351,Osteopathic Manipulative Treatment Alters Gastric Myoelectric Activity in Healthy Subjects.,"Objectives:  It is unclear whether osteopathic manipulative treatment (OMT) affects gastric myoelectric activity (GMA), an index of gastric motility. We hypothesized that OMT significantly alters power spectral density (PSD) analyses of electrogastrography (EGG) recordings, an index of GMA, compared with time control OMT.  Design:  GMA data were obtained from nine subjects before and after OMT and time control on separate days in a cross-over design. Fifteen-minute EGG recordings were obtained before and after each intervention and after a water challenge (WC). Percent power in the normogastric range (PPN) was estimated from PSD analyses. Absolute percent change of PPN and dominant frequency (DF) from baseline to postintervention and baseline to post-WC was computed and compared using two-way repeated-measures ANOVA.  Results:  OMT altered PPN versus time control (time control: 5.3% ± 1.2%; OMT: 24.5% ± 4.5%;  p  = 0.015). WC altered PPN compared with time control (post-time control ΔPPN: 5.3% ± 1.2%; post-drink ΔPPN: 30.3% ± 7.2%;  p  < 0.01). However, WC did not alter PPN with prior OMT treatment (post-OMT ΔPPN: 24.5% ± 4.5%; post-WC ΔPPN: 19.4% ± 5.6%;  p  = 0.47). Nevertheless, OMT reduced the rate of change for DF compared with time control (WC post-time control: 37.9% ± 7.4%; WC post-OMT: 20.0% ± 5.9%;  p  = 0.02).  Conclusions:  We conclude that (1) OMT significantly alters GMA compared with time control and that (2) OMT reduces the rate of change in the frequency response to WC within the normal frequency range of 2-4 cycles per minute, indicating a physiological effect.",2018,WC altered PPN compared with time control (post-time control ΔPPN: 5.3% ± 1.2%; post-drink ΔPPN: 30.3% ± 7.2%; p < 0.01).,['Healthy Subjects'],"['osteopathic manipulative treatment (OMT', 'Osteopathic Manipulative Treatment', 'OMT']","['rate of change for DF', 'power spectral density (PSD) analyses of electrogastrography (EGG) recordings, an index of GMA', 'Gastric Myoelectric Activity', 'GMA', 'PPN and dominant frequency (DF']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0949744', 'cui_str': 'Osteopathic Manipulative Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0430689', 'cui_str': 'Electromyography of stomach (procedure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",9.0,0.0389239,WC altered PPN compared with time control (post-time control ΔPPN: 5.3% ± 1.2%; post-drink ΔPPN: 30.3% ± 7.2%; p < 0.01).,"[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Shadiack', 'Affiliation': 'Department of Osteopathic Manipulative Medicine, University of North Texas Health Science Center, Fort Worth, Texas.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Jouett', 'Affiliation': 'Institute for Cardiovascular and Metabolic Disease, University of North Texas Health Science Center, Fort Worth, Texas.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'van den Raadt', 'Affiliation': 'Department of Osteopathic Manipulative Medicine, University of North Texas Health Science Center, Fort Worth, Texas.'}, {'ForeName': 'Roselle', 'Initials': 'R', 'LastName': 'Liganor', 'Affiliation': 'Department of Osteopathic Manipulative Medicine, University of North Texas Health Science Center, Fort Worth, Texas.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Watters', 'Affiliation': 'Department of Osteopathic Manipulative Medicine, University of North Texas Health Science Center, Fort Worth, Texas.'}, {'ForeName': 'Kendi', 'Initials': 'K', 'LastName': 'Hensel', 'Affiliation': 'Department of Osteopathic Manipulative Medicine, University of North Texas Health Science Center, Fort Worth, Texas.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'Institute for Cardiovascular and Metabolic Disease, University of North Texas Health Science Center, Fort Worth, Texas.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2018.0277']
1354,31776371,Disassociation of Vitamin D's Calcemic Activity and Non-calcemic Genomic Activity and Individual Responsiveness: A Randomized Controlled Double-Blind Clinical Trial.,"The aims of this randomized controlled double-blind clinical trial were to assess the impact of vitamin D supplementation on calcium metabolism and non-calcemic broad gene expression by relating them to the individual's responsiveness to varying doses of vitamin D 3 . Thirty healthy adults were randomized to receive 600, 4,000 or 10,000 IU/d of vitamin D 3  for 6 months. Circulating parathyroid hormone (PTH), 25(OH)D, calcium and peripheral white blood cells broad gene expression were evaluated. We observed a dose-dependent increase in 25(OH)D concentrations, decreased PTH and no change in serum calcium. A plateau in PTH levels was achieved at 16 weeks in the 4000 and 10,000 IU/d groups. There was a dose-dependent 25(OH)D alteration in broad gene expression with 162, 320 and 1289 genes up- or down-regulated in their white blood cells, respectively. Our results clearly indicated that there is an individual's responsiveness on broad gene expression to varying doses of vitamin D 3 . Vitamin D 3  supplementation at 10,000 IU/d produced genomic alterations several fold higher than 4,000 IU/d even without further changes in PTH levels. Our findings may help explain why there are some inconsistency in the results of different vitamin D's clinical trials.",2019,"There was a dose-dependent 25(OH)D alteration in broad gene expression with 162, 320 and 1289 genes up- or down-regulated in their white blood cells, respectively.",['Thirty healthy adults'],"['Vitamin D 3  supplementation', 'vitamin D supplementation', 'vitamin D']","['25(OH)D concentrations, decreased PTH and no change in serum calcium', 'Circulating parathyroid hormone (PTH), 25(OH)D, calcium and peripheral white blood cells broad gene expression', 'PTH levels', ""Disassociation of Vitamin D's Calcemic Activity and Non-calcemic Genomic Activity and Individual Responsiveness""]","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",30.0,0.576018,"There was a dose-dependent 25(OH)D alteration in broad gene expression with 162, 320 and 1289 genes up- or down-regulated in their white blood cells, respectively.","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Shirvani', 'Affiliation': 'Boston University School of Medicine, Boston Medical Campus, Section Endocrinology, Diabetes, Nutrition and Weight Management, Department of Medicine, Vitamin D, Skin, and Bone Research Laboratory, Boston, MA, 02118, USA.'}, {'ForeName': 'Tyler Arek', 'Initials': 'TA', 'LastName': 'Kalajian', 'Affiliation': 'Boston University School of Medicine, Boston Medical Campus, Section Endocrinology, Diabetes, Nutrition and Weight Management, Department of Medicine, Vitamin D, Skin, and Bone Research Laboratory, Boston, MA, 02118, USA.'}, {'ForeName': 'Anjeli', 'Initials': 'A', 'LastName': 'Song', 'Affiliation': 'Boston University School of Medicine, Boston Medical Campus, Section Endocrinology, Diabetes, Nutrition and Weight Management, Department of Medicine, Vitamin D, Skin, and Bone Research Laboratory, Boston, MA, 02118, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Holick', 'Affiliation': 'Boston University School of Medicine, Boston Medical Campus, Section Endocrinology, Diabetes, Nutrition and Weight Management, Department of Medicine, Vitamin D, Skin, and Bone Research Laboratory, Boston, MA, 02118, USA. mfholick@bu.edu.'}]",Scientific reports,['10.1038/s41598-019-53864-1']
1355,30861532,Endoscopic tissue shielding to prevent bleeding after endoscopic submucosal dissection: a prospective multicenter randomized controlled trial.,"BACKGROUND


Bleeding after endoscopic submucosal dissection (ESD) is a severe adverse event. Recent reports have described the efficacy of the endoscopic shielding method with polyglycolic acid (PGA) sheets and fibrin glue for the prevention of adverse events after ESD. The aim of the present study was to investigate whether the PGA shielding method provides additional benefit in preventing post-ESD bleeding compared with standard care.
METHODS


This was a prospective, multicenter, randomized controlled trial. Patients at high risk of post-ESD bleeding were enrolled in the study. Before ESD, patients were randomized to either the PGA group or the control group. After completing ESD in the PGA group, PGA sheets were placed onto the ulcer floor and adhered with fibrin glue. The primary end point was the post-ESD bleeding rate.
RESULTS


140 eligible patients were enrolled from September 2014 to September 2016, and 137 were included in the intention-to-treat analysis (67 in the PGA group and 70 in the control group). Post-ESD bleeding occurred in three patients (4.5 %) in the PGA group and in four patients (5.7 %) in the control group; there was no significant difference between the two groups ( P  > 0.99). Post-ESD bleeding tended to occur later in the control group than in the PGA group (median 12.5 days [range 8 - 14] vs. 2 days [range 0 - 7], respectively).
CONCLUSION


The PGA shielding method did not demonstrate a significant effect on the prevention of post-ESD bleeding.",2019,Post-ESD bleeding occurred in three patients (4.5 %) in the PGA group and in four patients (5.7 %) in the control group; there was no significant difference between the two groups ( P  > 0.99).,"['140 eligible patients were enrolled from September 2014 to September 2016, and 137 were included in the intention-to-treat analysis (67 in the PGA group and 70 in the control group', 'Patients at high risk of post-ESD bleeding were enrolled in the study']","['endoscopic submucosal dissection (ESD', 'polyglycolic acid (PGA) sheets and fibrin glue', 'PGA', 'fibrin glue', 'Endoscopic tissue shielding']","['Post-ESD bleeding', 'prevention of post-ESD bleeding', 'post-ESD bleeding rate']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0032502', 'cui_str': 'Polyglycolide'}, {'cui': 'C0439643', 'cui_str': 'Sheets (qualifier value)'}, {'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",140.0,0.0500468,Post-ESD bleeding occurred in three patients (4.5 %) in the PGA group and in four patients (5.7 %) in the control group; there was no significant difference between the two groups ( P  > 0.99).,"[{'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Kataoka', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kingo', 'Initials': 'K', 'LastName': 'Hirasawa', 'Affiliation': 'Division of Endoscopy, Yokohama City University Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Takimoto', 'Affiliation': 'Department of Gastroenterology, Takeda General Hospital, Kyoto, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Gastroenterology, Sanraku Hospital, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Mochizuki', 'Affiliation': 'Shinagawa Gut Clinic, Tokyo, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ohata', 'Affiliation': 'Department of Gastroenterology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Sakaguchi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Niimi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ono', 'Affiliation': 'Department of Gastroenterology, Chiba-Nishi General Hospital, Matsudo, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Kodashima', 'Affiliation': 'Department of Gastroenterology, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobutake', 'Initials': 'N', 'LastName': 'Yamamichi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Fujishiro', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Koike', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",Endoscopy,['10.1055/a-0860-5280']
1356,30215171,Supranutritional Sodium Selenate Supplementation Delivers Selenium to the Central Nervous System: Results from a Randomized Controlled Pilot Trial in Alzheimer's Disease.,"Insufficient supply of selenium to antioxidant enzymes in the brain may contribute to Alzheimer's disease (AD) pathophysiology; therefore, oral supplementation may potentially slow neurodegeneration. We examined selenium and selenoproteins in serum and cerebrospinal fluid (CSF) from a dual-dose 24-week randomized controlled trial of sodium selenate in AD patients, to assess tolerability, and efficacy of selenate in modulating selenium concentration in the central nervous system (CNS). A pilot study of 40 AD cases was randomized to placebo, nutritional (0.32 mg sodium selenate, 3 times daily), or supranutritional (10 mg, 3 times daily) groups. We measured total selenium, selenoproteins, and inorganic selenium levels, in serum and CSF, and compared against cognitive outcomes. Supranutritional selenium supplementation was well tolerated and yielded a significant (p < 0.001) but variable (95% CI = 13.4-24.8 μg/L) increase in CSF selenium, distributed across selenoproteins and inorganic species. Reclassifying subjects as either responsive or non-responsive based on elevation in CSF selenium concentrations revealed that responsive group did not deteriorate in Mini-Mental Status Examination (MMSE) as non-responsive group (p = 0.03). Pooled analysis of all samples revealed that CSF selenium could predict change in MMSE performance (Spearman's rho = 0.403; p = 0.023). High-dose sodium selenate supplementation is well tolerated and can modulate CNS selenium concentration, although individual variation in selenium metabolism must be considered to optimize potential benefits in AD. The Vel002 study is listed on the Australian and New Zealand Clinical Trials Registry ( http://www.anzctr.org.au /), ID: ACTRN12611001200976.",2019,"Supranutritional selenium supplementation was well tolerated and yielded a significant (p < 0.001) but variable (95% CI = 13.4-24.8 μg/L) increase in CSF selenium, distributed across selenoproteins and inorganic species.","['Central Nervous System', ""Alzheimer's Disease"", '40 AD cases', 'AD patients']","['placebo, nutritional (0.32\xa0mg sodium selenate, 3 times daily), or supranutritional', 'Supranutritional selenium supplementation']","['MMSE performance', 'CSF selenium', 'CSF selenium concentrations', 'total selenium, selenoproteins, and inorganic selenium levels, in serum and CSF, and compared against cognitive outcomes']","[{'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517448', 'cui_str': 'Zero point three two'}, {'cui': 'C0074765', 'cui_str': 'sodium selenate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0074302', 'cui_str': 'Selenoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",40.0,0.0610001,"Supranutritional selenium supplementation was well tolerated and yielded a significant (p < 0.001) but variable (95% CI = 13.4-24.8 μg/L) increase in CSF selenium, distributed across selenoproteins and inorganic species.","[{'ForeName': 'Barbara R', 'Initials': 'BR', 'LastName': 'Cardoso', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia. barbara.r@deakin.edu.au.'}, {'ForeName': 'Blaine R', 'Initials': 'BR', 'LastName': 'Roberts', 'Affiliation': 'Melbourne Dementia Research Centre, The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, 30 Royal Parade, Parkville, Victoria, 3052, Australia.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Malpas', 'Affiliation': 'Department of Medicine, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Vivash', 'Affiliation': 'Department of Medicine, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sila', 'Initials': 'S', 'LastName': 'Genc', 'Affiliation': ""Developmental Imaging, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Saling', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Desmond', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Steward', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rodney J', 'Initials': 'RJ', 'LastName': 'Hicks', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Callahan', 'Affiliation': 'Centre for Molecular Imaging, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Brodtmann', 'Affiliation': 'Melbourne Dementia Research Centre, The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, 30 Royal Parade, Parkville, Victoria, 3052, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': 'Department of Medicine, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Macfarlane', 'Affiliation': 'Caulfield Hospital, Alfred Health, Caulfield, Victoria, Australia.'}, {'ForeName': 'Niall M', 'Initials': 'NM', 'LastName': 'Corcoran', 'Affiliation': 'Department of Surgery, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Hovens', 'Affiliation': 'Department of Surgery, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Velakoulis', 'Affiliation': 'Department of Psychiatry, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Medicine, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dominic J', 'Initials': 'DJ', 'LastName': 'Hare', 'Affiliation': 'Melbourne Dementia Research Centre, The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, 30 Royal Parade, Parkville, Victoria, 3052, Australia. dominic.hare@florey.edu.au.'}, {'ForeName': 'Ashley I', 'Initials': 'AI', 'LastName': 'Bush', 'Affiliation': 'Melbourne Dementia Research Centre, The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, 30 Royal Parade, Parkville, Victoria, 3052, Australia.'}]",Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics,['10.1007/s13311-018-0662-z']
1357,31787550,Gonadotrophins or clomiphene citrate in couples with unexplained infertility undergoing intrauterine insemination: a cost-effectiveness analysis.,"RESEARCH QUESTION


What is the cost-effectiveness of gonadotrophins compared with clomiphene citrate in couples with unexplained subfertility undergoing intrauterine insemination (IUI) with ovarian stimulation under strict cancellation criteria?
DESIGN


A cost-effectiveness analysis alongside a randomized controlled trial (RCT). Between July 2013 and March 2016, 738 couples were randomized to gonadotrophins (369) or clomiphene citrate (369) in a multicentre RCT in the Netherlands. The direct medical costs of both strategies were compared. Direct medical costs included costs of medication, cycle monitoring, insemination and, if applicable, pregnancy monitoring. Non-parametric bootstrap resampling was used to investigate the effect of uncertainty in estimates. The cost-effectiveness analysis was performed according to intention-to-treat. The incremental cost-effectiveness ratio (ICER) between gonadotrophins and clomiphene citrate for ongoing pregnancy and live birth was assessed.
RESULTS


The mean costs per couple were €1534 for gonadotrophins and €1067 for clomiphene citrate (mean difference of €468; 95% confidence interval [CI] €464-472). As ongoing pregnancy rates were 31% in women allocated to gonadotrophins and 26% in women allocated to clomiphene citrate (relative risk 1.16, 95% CI 0.93-1.47), the ICER was €21,804 (95% CI €11,628-31,980) per additional ongoing pregnancy with gonadotrophins and €17,044 (95% CI €8998-25,090) per additional live birth with gonadotrophins.
CONCLUSIONS


Gonadotrophins are more expensive compared with clomiphene citrate in couples with unexplained subfertility undergoing IUI with adherence to strict cancellation criteria, without being significantly more effective.",2020,The mean costs per couple were €1534 for gonadotrophins and €1067 for clomiphene citrate (mean difference of €468; 95% confidence interval [CI] €464-472).,"['couples with unexplained infertility undergoing intrauterine insemination', 'Between July 2013 and March 2016, 738 couples', '€11,628-31,980) per additional ongoing pregnancy with gonadotrophins and €17,044', 'couples with unexplained subfertility undergoing IUI', 'couples with unexplained subfertility undergoing intrauterine insemination (IUI) with ovarian stimulation under strict cancellation criteria']","['Gonadotrophins or clomiphene citrate', 'clomiphene citrate', 'gonadotrophins and clomiphene citrate', 'gonadotrophins']","['pregnancy rates', 'costs of medication, cycle monitoring, insemination and, if applicable, pregnancy monitoring', 'incremental cost-effectiveness ratio (ICER', 'ICER', 'mean costs per couple']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0729353', 'cui_str': 'Sub-Fertility'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]",738.0,0.227139,The mean costs per couple were €1534 for gonadotrophins and €1067 for clomiphene citrate (mean difference of €468; 95% confidence interval [CI] €464-472).,"[{'ForeName': 'Noor A', 'Initials': 'NA', 'LastName': 'Danhof', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Madelon', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Repping', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'van der Ham', 'Affiliation': 'Department of Obstetrics and Gynaecology, Martini Hospital, Groningen, the Netherlands.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Klijn', 'Affiliation': 'Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Ineke C A H', 'Initials': 'ICAH', 'LastName': 'Janssen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Groene Hart Hospital, Gouda, the Netherlands.'}, {'ForeName': 'Janne-Meije', 'Initials': 'JM', 'LastName': 'Rijn-van Weert', 'Affiliation': 'Department of Obstetrics and Gynaecology, NoordWest Groep Alkmaar, Alkmaar, the Netherlands.'}, {'ForeName': 'Moniek', 'Initials': 'M', 'LastName': 'Twisk', 'Affiliation': 'Department of Obstetrics and Gynaecology, MC Zuiderzee, Lelystad, the Netherlands.'}, {'ForeName': 'Maaike A F', 'Initials': 'MAF', 'LastName': 'Traas', 'Affiliation': 'Department of Obstetrics and Gynaecology, Gelre Hospital, Apeldoorn, the Netherlands.'}, {'ForeName': 'Marie-Louise J', 'Initials': 'MJ', 'LastName': 'Pelinck', 'Affiliation': 'Department of Obstetrics and Gynaecology, Scheper Hospital, Emmen, the Netherlands.'}, {'ForeName': 'Denise A M', 'Initials': 'DAM', 'LastName': 'Perquin', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Dominique E S', 'Initials': 'DES', 'LastName': 'Boks', 'Affiliation': 'Department of Obstetrics and Gynaecology, Spaarne Hospital, Hoofddorp, the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sluijmer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Wilhelmina Hospital, Assen, the Netherlands.'}, {'ForeName': 'Ben W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Monash University, Monash Medical Centre, Clayton Victoria, Australia.'}, {'ForeName': 'Fulco', 'Initials': 'F', 'LastName': 'van der Veen', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Monique H', 'Initials': 'MH', 'LastName': 'Mochtar', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands. Electronic address: m.h.mochtar@amc.uva.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Reproductive biomedicine online,['10.1016/j.rbmo.2019.09.004']
1358,31079993,Are Patients More Satisfied With a Balanced Total Knee Arthroplasty?,"BACKGROUND


Patient-reported outcome measures are increasingly recognized as an important tool in quantifying the clinical success of arthroplasty surgery. The aim of this study is to measure post-operative joint awareness and satisfaction in patients with and without a quantitatively balanced knee following primary total knee arthroplasty (TKA).
METHODS


In this multi-center study, a total of 318 eligible patients were assigned to one of the 2 patient groups: sensor-guided TKA or surgeon-guided TKA. In the sensor-guided group, quantitative balancing was performed according to intercompartmental tibiofemoral load measurements measured by an instrumented tibial trial component. In contrast, for the surgeon-guided group, the knees were balanced according to the surgeons' standard manual techniques while blinding the surgeon to the sensor measurements. Patients were blinded to their allocation and filled out the validated Forgotten Joint Score and 2011 Knee Society Satisfaction questionnaires at 6 weeks and 6 months. For the purposes of this study, the subjects were pooled and stratified by their state of soft tissue balance, based on the mediolateral load differential through the range of motion.
RESULTS


In the surgeon-guided group, approximately 50% of the cases yielded a quantitatively balanced knee. Significantly more balanced knees were observed in the sensor-guided group (84.0%). More importantly, for both outcome measures, the balanced group of patients reported significantly better outcomes scores.
CONCLUSION


This demonstrates that using sensor feedback during knee arthroplasty surgery results in a more reproducible procedure, resulting in a higher percentage of balanced patients who in turn demonstrate superior clinical outcomes compared to unbalanced patients.",2019,Significantly more balanced knees were observed in the sensor-guided group (84.0%).,"['patients with and without a quantitatively balanced knee following primary total knee arthroplasty (TKA', '318 eligible patients were assigned to one of the 2 patient groups']",['sensor-guided TKA or surgeon-guided TKA'],['balanced knees'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]",318.0,0.0401875,Significantly more balanced knees were observed in the sensor-guided group (84.0%).,"[{'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Golladay', 'Affiliation': 'Department of Orthopaedic Surgery, Virginia Commonwealth University Health, Richmond, Virginia.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Bradbury', 'Affiliation': 'Department of Orthopaedic Surgery, Emory Healthcare, Atlanta, Georgia.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Illinois Bone and Joint Institute, Morton Grove, Illinois.'}, {'ForeName': 'Ivan J', 'Initials': 'IJ', 'LastName': 'Fernandez-Madrid', 'Affiliation': 'NYU Orthopaedic Surgery Associates, NYU Langone Health, New York, New York.'}, {'ForeName': 'Viktor E', 'Initials': 'VE', 'LastName': 'Krebs', 'Affiliation': 'Department of Orthopaedic Surgery, The Cleveland Clinic Foundation A41, Cleveland, Ohio.'}, {'ForeName': 'Preetesh D', 'Initials': 'PD', 'LastName': 'Patel', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Florida - Weston, Weston, Florida.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Suarez', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Florida - Weston, Weston, Florida; Miami Orthopaedics and Sports Medicine Institute, Baptist Health South Florida, Miami, Florida.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Higuera Rueda', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Florida - Weston, Weston, Florida.'}, {'ForeName': 'Wael K', 'Initials': 'WK', 'LastName': 'Barsoum', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Florida - Weston, Weston, Florida.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.03.036']
1359,31765480,Results of CoALL 07-03 study childhood ALL based on combined risk assessment by in vivo and in vitro pharmacosensitivity.,"We conducted a clinical trial and report the long-term outcome of 773 children with acute lymphoblastic leukemia upon risk-adapted therapy accrued in trial CoALL 07-03 (from the Cooperative Study Group for Childhood Acute Lymphoblastic Leukemia). In a 2-step stratification, patients were allocated to receive either low- or high-risk treatment, based on initial white blood cell count, age, and immunophenotype. A second stratification was performed according to the results of in vitro pharmacosensitivity toward prednisolone, vincristine, and asparaginase (PVA score) and in vivo response after induction therapy (minimal residual disease [MRD]). Therapy was reduced for both risk groups in patients with a low PVA score or negative MRD result, and intensified in patients with a high PVA score. Overall outcome improved significantly compared with the predecessor CoALL 06-97 trial, with identical therapy backbone despite treatment reduction in 15.8% of patients (10-year probability of event-free survival, 83.5% vs 73.9%; overall survival, 90.7% vs 83.8%). Outcome for patients in the reduced treatment arms was superior to that of patients in the standard arms, associated with a profound reduction in frequency and severity of infectious complications. Importantly, we observed a lack of correlation between in vitro and in vivo drug response, as well as a lower predictive value of in vitro drug testing, reflecting an intrinsic limitation of this methodology that prevents its use for treatment stratification in future trials. In conclusion, it might be possible to reduce chemotherapy in children with acute lymphoblastic leukemia selected by stringent in vivo measurement of MRD without jeopardizing overall outcome.",2019,"Overall outcome improved significantly compared with the predecessor CoALL 06-97 trial, with identical therapy backbone despite treatment reduction in 15.8% of patients (10-year probability of event-free survival, 83.5% vs 73.9%; overall survival, 90.7% vs 83.8%).","['773 children with acute lymphoblastic leukemia upon risk-adapted therapy accrued in trial CoALL 07-03 (from the Cooperative Study Group for Childhood Acute Lymphoblastic Leukemia', 'children with acute lymphoblastic leukemia']","['prednisolone, vincristine, and asparaginase (PVA score', 'low- or high-risk treatment']","['frequency and severity of infectious complications', 'overall survival']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",773.0,0.0437374,"Overall outcome improved significantly compared with the predecessor CoALL 06-97 trial, with identical therapy backbone despite treatment reduction in 15.8% of patients (10-year probability of event-free survival, 83.5% vs 73.9%; overall survival, 90.7% vs 83.8%).","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Schramm', 'Affiliation': 'Clinic of Pediatric Hematology and Oncology, University Medical Centre, Hamburg-Eppendorf Hamburg, Germany.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Zur Stadt', 'Affiliation': 'Clinic of Pediatric Hematology and Oncology, University Medical Centre, Hamburg-Eppendorf Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Medical School Hannover, Hannover, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Jorch', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Hospital Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Pekrun', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Hospital Bremen-Mitte, Bremen, Germany.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Borkhardt', 'Affiliation': 'Department of Pediatric Oncology, Hematology and Clinical Immunology, Medical Faculty Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Imschweiler', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Helios Hospital, Krefeld, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Christiansen', 'Affiliation': 'Clinic of Pediatric Hematology and Oncology, University Medical Centre Leipzig, Leipzig, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Pediatric Hematology/Oncology, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schmid', 'Affiliation': ""Dr. von Hauner Children's Hospital, Ludwig Maximilian University, Munich, Germany.""}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Feuchtinger', 'Affiliation': ""Dr. von Hauner Children's Hospital, Ludwig Maximilian University, Munich, Germany.""}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Beron', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Helios Hospital, Wiesbaden, Germany.'}, {'ForeName': 'Monique L', 'Initials': 'ML', 'LastName': 'den Boer', 'Affiliation': 'Princess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands; and.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Pieters', 'Affiliation': 'Princess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands; and.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Horstmann', 'Affiliation': 'Clinic of Pediatric Hematology and Oncology, University Medical Centre, Hamburg-Eppendorf Hamburg, Germany.'}, {'ForeName': 'Gritta E', 'Initials': 'GE', 'LastName': 'Janka-Schaub', 'Affiliation': 'Clinic of Pediatric Hematology and Oncology, University Medical Centre, Hamburg-Eppendorf Hamburg, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Escherich', 'Affiliation': 'Clinic of Pediatric Hematology and Oncology, University Medical Centre, Hamburg-Eppendorf Hamburg, Germany.'}]",Blood advances,['10.1182/bloodadvances.2019000576']
1360,31782408,Protective Effects of Dexmedetomidine and Oxycodone in Patients Undergoing Limb Ischemia-Reperfusion.,"BACKGROUND Tourniquet-related complications are a common clinical problem. In the present study, we compared the effects of dexmedetomidine vs. oxycodone in patients undergoing limb ischemia-reperfusion. MATERIAL AND METHODS Fifty-four patients undergoing unilateral lower-extremity surgery under combined spinal and epidural anesthesia were randomly assigned to a control (ischemia-reperfusion, I/R) group, a dexmedetomidine (Dex) group, and an oxycodone (Oxy) group. Tourniquet-induced hemodynamic parameters changes among groups were compared. The serum concentration of malondialdehyde (MDA), superoxide dismutase (SOD), tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), fatty acid binding protein 3 (FABP3), endothelin-1 (ET-1), and brain-derived neurotrophic factor (BDNF) were measured using ELISA before anesthesia and at 30 min and at 6 h after tourniquet release. RESULTS In the control group, tourniquet use caused significant increases in systolic arterial pressure (SAP), mean arterial pressure (MAP), diastolic arterial pressure (DAP), and rate-pressure product. Compared with Oxy, Dex significantly decreased heart rate (HR). Both Dex and Oxy lowered SAP compared with the control group. No significant difference was observed in DAP between Dex and Oxy. The levels of MDA, TNF-alpha, IL-6, FABP3, and ET-1 were significantly higher, while the SOD and BDNF were significantly lower compared to baseline in the I/R group, but the variation range of those agents was significantly smaller in the Dex and Oxy groups, and the measured values were comparable between the 2 groups. CONCLUSIONS Compared with Dex, Oxy was not inferior in mitigating tourniquet-induced hyperdynamic response, ameliorating the inflammatory reaction, and protecting remote multiple organs in lower-extremity surgery patients.",2019,"The serum concentration of malondialdehyde (MDA), superoxide dismutase (SOD), tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), fatty acid binding protein 3 (FABP3), endothelin-1 (ET-1), and brain-derived neurotrophic factor (BDNF) were measured using ELISA before anesthesia and at 30 min and at 6 h after tourniquet release.","['patients undergoing limb ischemia-reperfusion', 'Patients Undergoing Limb Ischemia-Reperfusion', 'Fifty-four patients undergoing unilateral lower-extremity surgery under combined spinal and epidural anesthesia']","['oxycodone (Oxy) group', 'dexmedetomidine vs. oxycodone', 'dexmedetomidine (Dex', 'control (ischemia-reperfusion, I/R', 'Dexmedetomidine and Oxycodone', 'Oxy, Dex']","['systolic arterial pressure (SAP), mean arterial pressure (MAP), diastolic arterial pressure (DAP), and rate-pressure product', 'heart rate (HR', 'levels of MDA, TNF-alpha, IL-6, FABP3, and ET-1', 'DAP', 'serum concentration of malondialdehyde (MDA), superoxide dismutase (SOD), tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), fatty acid binding protein 3 (FABP3), endothelin-1 (ET-1), and brain-derived neurotrophic factor (BDNF', 'SOD and BDNF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945695', 'cui_str': 'Limb ischemia'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic Pressure'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0525921', 'cui_str': 'alpha,beta-diacryloxypropionic acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C4319579', 'cui_str': 'H-FABP'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}]",54.0,0.0485364,"The serum concentration of malondialdehyde (MDA), superoxide dismutase (SOD), tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), fatty acid binding protein 3 (FABP3), endothelin-1 (ET-1), and brain-derived neurotrophic factor (BDNF) were measured using ELISA before anesthesia and at 30 min and at 6 h after tourniquet release.","[{'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of HeBei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Mingjie', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of HeBei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of HeBei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of HeBei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of HeBei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of HeBei Medical University, Shijiazhuang, Hebei, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.918261']
1361,31615771,Clinical Utility of Procalcitonin in the Diagnosis of Pneumonia.,"BACKGROUND


The clinical utility of procalcitonin in the diagnosis and management of pneumonia remains controversial.
METHODS


We assessed the clinical utility of procalcitonin in 2 prospective studies: first, a multicenter diagnostic study in patients presenting to the emergency department with acute dyspnea to directly compare the diagnostic accuracy of procalcitonin with that of interleukin 6 and C-reactive protein (CRP) in the diagnosis of pneumonia; second, a randomized management study of procalcitonin guidance in patients with acute heart failure and suspected pneumonia. Diagnostic accuracy for pneumonia as centrally adjudicated by 2 independent experts was quantified with the area under the ROC curve (AUC).
RESULTS


Among 690 patients in the diagnostic study, 178 (25.8%) had an adjudicated final diagnosis of pneumonia. Procalcitonin, interleukin 6, and CRP were significantly higher in patients with pneumonia than in those without. When compared to procalcitonin (AUC = 0.75; 95% CI, 0.71-0.78), interleukin 6 (AUC = 0.80; 95% CI, 0.77-0.83) and CRP (AUC = 0.82; 95% CI, 0.79-0.85) had significantly higher diagnostic accuracy ( P  = 0.010 and  P  < 0.001, respectively). The management study was stopped early owing to the unexpectedly low AUC of procalcitonin in the diagnostic study. Among 45 randomized patients, the number of days on antibiotic therapy and the length of hospital stay were similar (both  P  = 0.39) in patients randomized to the procalcitonin-guided group (n = 25) and usual-care group (n = 20).
CONCLUSIONS


In patients presenting with dyspnea, diagnostic accuracy of procalcitonin for pneumonia is only moderate and lower than that of interleukin 6 and CRP. The clinical utility of procalcitonin was lower than expected.
SUMMARY


Pneumonia has diverse and often unspecific symptoms. As the role of biomarkers in the diagnosis of pneumonia remains controversial, it is often difficult to distinguish pneumonia from other illnesses causing shortness of breath. The current study prospectively enrolled unselected patients presenting with acute dyspnea and directly compared the diagnostic accuracy of procalcitonin, interleukin 6, and CRP for the diagnosis of pneumonia. In this setting, diagnostic accuracy of procalcitonin for pneumonia was lower as compared to interleukin 6 and CRP. The clinical utility of procalcitonin was lower than expected.
CLINICALTRIALSGOV IDENTIFIER


NCT01831115.",2019,"When compared to procalcitonin (AUC = 0.75; 95% CI, 0.71-0.78), interleukin 6 (AUC = 0.80; 95% CI, 0.77-0.83) and CRP (AUC = 0.82; 95% CI, 0.79-0.85) had significantly higher diagnostic accuracy ( P  = 0.010 and  P  < 0.001, respectively).","['690 patients in the diagnostic study, 178 (25.8%) had an adjudicated final diagnosis of pneumonia', 'patients presenting to the emergency department with acute dyspnea', 'enrolled unselected patients presenting with acute dyspnea and directly compared the diagnostic accuracy of procalcitonin, interleukin 6, and CRP for the diagnosis of pneumonia', 'patients with acute heart failure and suspected pneumonia']","['interleukin 6 and C-reactive protein (CRP', 'procalcitonin guidance']","['Procalcitonin, interleukin 6, and CRP', 'Diagnostic accuracy for pneumonia', 'diagnostic accuracy of procalcitonin for pneumonia', 'diagnostic accuracy', 'number of days on antibiotic therapy and the length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332144', 'cui_str': 'Final diagnosis (discharge) (contextual qualifier) (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0743323', 'cui_str': 'Acute dyspnea'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}]","[{'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",690.0,0.0307092,"When compared to procalcitonin (AUC = 0.75; 95% CI, 0.71-0.78), interleukin 6 (AUC = 0.80; 95% CI, 0.77-0.83) and CRP (AUC = 0.82; 95% CI, 0.79-0.85) had significantly higher diagnostic accuracy ( P  = 0.010 and  P  < 0.001, respectively).","[{'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Wussler', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Kozhuharov', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Mucio', 'Initials': 'M', 'LastName': 'Tavares Oliveira', 'Affiliation': 'GREAT network.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Bossa', 'Affiliation': 'GREAT network.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Sabti', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Albina', 'Initials': 'A', 'LastName': 'Nowak', 'Affiliation': 'Department of Endocrinology and Clinical Nutrition, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'du Fay de Lavallaz', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Badertscher', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Twerenbold', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Samyut', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Dayana', 'Initials': 'D', 'LastName': 'Flores', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nestelberger', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Boeddinghaus', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Zimmermann', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Koechlin', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'von Eckardstein', 'Affiliation': 'Department of Laboratory Medicine, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Breidthardt', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; christian.mueller@usb.ch.'}]",Clinical chemistry,['10.1373/clinchem.2019.306787']
1362,31195825,Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions.,"Background While randomized trials have demonstrated the superiority of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal peripheral artery disease, the long-term durability of DCB angioplasty remains uncertain. Methods and Results IN.PACT SFA is a prospective, multicenter, randomized single-blinded trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 subjects with symptomatic (Rutherford 2-4) femoropopliteal lesions. Subjects were randomly assigned 2:1 to the IN.PACT Admiral DCB or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the primary safety end point, and major adverse events. Through 5 years, patients treated with the IN.PACT Admiral DCB demonstrated a sustained treatment effect with superior freedom from clinically driven target lesion revascularization when compared with PTA (Kaplan-Meier estimate of 74.5% versus 65.3%; log-rank P=0.020). The primary safety composite was achieved in 70.7% of subjects in the DCB and 59.6% in the PTA groups ( P=0.068). The major adverse event rate was 42.9% for DCB and 48.1% for PTA ( P=0.459). There were no device- or procedure-related deaths in either group as adjudicated by an independent and blinded Clinical Events Committee. Conclusions The IN.PACT SFA randomized trial demonstrates that the IN.PACT Admiral DCB continues to perform better than PTA through 5 years with higher freedom from clinically driven target lesion revascularization. The sustained safety and effectiveness profile of this DCB supports its use as a preferred treatment choice compared with PTA for femoropopliteal lesions. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT01175850 (IN.PACT SFA phase I) and NCT01566461 (IN.PACT SFA phase II).",2019,There were no device- or procedure-related deaths in either group as adjudicated by an independent and blinded Clinical Events Committee.,"['patients with femoropopliteal peripheral artery disease', 'that enrolled 331 subjects with symptomatic (Rutherford 2-4) femoropopliteal lesions', 'Femoropopliteal Lesions', 'Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA']","['DCB', 'IN.PACT Admiral DCB', 'Drug-Coated Balloon', 'drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA', 'IN.PACT SFA', 'IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty', 'IN.PACT Admiral DCB or PTA', 'PTA] Balloon Catheter vs Standard PTA']","['device- or procedure-related deaths', 'major adverse event rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery (body structure)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0032649', 'cui_str': 'Popliteal Artery'}]","[{'cui': 'C4521767', 'cui_str': 'US Military Commissioned Officer O10'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous Transluminal Angioplasty'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter (physical object)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",331.0,0.105822,There were no device- or procedure-related deaths in either group as adjudicated by an independent and blinded Clinical Events Committee.,"[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Laird', 'Affiliation': 'Adventist Heart and Vascular Institute, St Helena, CA (J.A.L.).'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Schneider', 'Affiliation': 'Kaiser Foundation Hospital, Honolulu, HI (P.A.S.).'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': 'Harvard Medical School, Boston, MA (M.R.J.).'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'Medical University, Graz, Austria (M.B.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': 'Universitaets-Herzzentrum Freiburg-Bad Krozingen, Germany (T.Z.).'}, {'ForeName': 'D Chris', 'Initials': 'DC', 'LastName': 'Metzger', 'Affiliation': 'Ballad Health Systems CVA Heart & Vascular Institute, Kingsport, TN (D.C.M.).'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Krishnan', 'Affiliation': 'The Mount Sinai Hospital, New York, NY (P.K.).'}, {'ForeName': 'Dierk', 'Initials': 'D', 'LastName': 'Scheinert', 'Affiliation': 'University Hospital Leipzig, Germany (D.S.).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Micari', 'Affiliation': 'Gavazzeni Hospital Humanitas, Bergamo, Italy (A.M.).'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Medtronic Inc, Santa Rosa, CA (H.W., M.M.).'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Masters', 'Affiliation': 'Medtronic Inc, Santa Rosa, CA (H.W., M.M.).'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Tepe', 'Affiliation': 'Ro Med Clinic Rosenheim, Germany (G.T.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.118.007702']
1363,31116358,Effect of Targeting Mean Arterial Pressure During Cardiopulmonary Bypass by Monitoring Cerebral Autoregulation on Postsurgical Delirium Among Older Patients: A Nested Randomized Clinical Trial.,"Importance


Delirium occurs in up to 52% of patients after cardiac surgery and may result from changes in cerebral perfusion. Using intraoperative cerebral autoregulation monitoring to individualize and optimize cerebral perfusion may be a useful strategy to reduce the incidence of delirium after cardiac surgery.
Objective


To determine whether targeting mean arterial pressure during cardiopulmonary bypass (CPB) using cerebral autoregulation monitoring reduces the incidence of delirium compared with usual care.
Design, Setting, and Participants


This randomized clinical trial nested within a larger trial enrolled patients older than 55 years who underwent nonemergency cardiac surgery at a single US academic medical center between October 11, 2012, and May 10, 2016, and had a high risk for neurologic complications. Patients, physicians, and outcome assessors were masked to the assigned intervention. A total of 2764 patients were screened, and 199 were eligible for analysis in this study.
Intervention


In the intervention group, the patient's lower limit of cerebral autoregulation was identified during surgery before CPB. On CPB, the patient's mean arterial pressure was targeted to be greater than that patient's lower limit of autoregulation. In the control group, mean arterial pressure targets were determined according to institutional practice.
Main Outcomes and Measures


The main outcome was any incidence of delirium on postoperative days 1 through 4, as adjudicated by a consensus expert panel.
Results


Among the 199 participants in this study, mean (SD) age was 70.3 (7.5) years and 150 (75.4%) were male. One hundred sixty-two (81.4%) were white, 26 (13.1%) were black, and 11 (5.5%) were of other race. Of 103 patients randomized to usual care, 94 were analyzed, and of 102 patients randomized to the intervention 105 were analyzed. Excluding 5 patients with coma, delirium occurred in 48 of the 91 patients (53%) in the usual care group compared with 39 of the 103 patients (38%) in the intervention group (P = .04). The odds of delirium were reduced by 45% in patients randomized to the autoregulation group (odds ratio, 0.55; 95% CI, 0.31-0.97; P = .04).
Conclusions and Relevance


The results of this study suggest that optimizing mean arterial pressure to be greater than the individual patient's lower limit of cerebral autoregulation during CPB may reduce the incidence of delirium after cardiac surgery, but further study is needed.
Trial Registration


ClinicalTrials.gov identifier: NCT00981474.",2019,"Excluding 5 patients with coma, delirium occurred in 48 of the 91 patients (53%) in the usual care group compared with 39 of the 103 patients (38%) in the intervention group (P = .04).","['199 participants in this study, mean (SD) age was 70.3 (7.5) years and 150 (75.4%) were male', 'Older Patients', 'A total of 2764 patients were screened, and 199 were eligible for analysis in this study', '103 patients randomized to usual care, 94 were analyzed, and of 102 patients randomized to the intervention 105 were analyzed', 'One hundred sixty-two (81.4%) were white, 26 (13.1%) were black, and 11 (5.5%) were of other race', 'larger trial enrolled patients older than 55 years who underwent nonemergency cardiac surgery at a single US academic medical center between October 11, 2012, and May 10, 2016, and had a high risk for neurologic complications']","['Mean Arterial Pressure During Cardiopulmonary Bypass by Monitoring Cerebral Autoregulation', 'cardiopulmonary bypass (CPB) using cerebral autoregulation monitoring']","['odds of delirium', 'cerebral autoregulation', 'cerebral perfusion', 'delirium', 'incidence of delirium', 'mean arterial pressure targets', 'mean arterial pressure']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",2764.0,0.273762,"Excluding 5 patients with coma, delirium occurred in 48 of the 91 patients (53%) in the usual care group compared with 39 of the 103 patients (38%) in the intervention group (P = .04).","[{'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Karin J', 'Initials': 'KJ', 'LastName': 'Neufeld', 'Affiliation': 'Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Probert', 'Affiliation': 'School of Medicine, New York University, New York.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'LaFlam', 'Affiliation': 'Medical Student, School of Medicine, Tufts University, Medford Massachusetts.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Max', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Daijiro', 'Initials': 'D', 'LastName': 'Hori', 'Affiliation': 'Department of Cardiovascular Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Nomura', 'Affiliation': 'Department of Cardiovascular Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan.'}, {'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Mandal', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Penn State University Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Brady', 'Affiliation': 'Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Hogue', 'Affiliation': 'Bluhm Cardiovascular Institute, Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Department of Cardiac Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Kenton', 'Initials': 'K', 'LastName': 'Zehr', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Duke', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Massachusetts General Hospital, Boston.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Conte', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Penn State University Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'O Joseph', 'Initials': 'OJ', 'LastName': 'Bienvenu', 'Affiliation': 'Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gottesman', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yamaguchi', 'Affiliation': 'Saitama Medical Center, Jichi Medical University, Saitama, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kraut', 'Affiliation': 'Department of Radiology and Radiological Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA surgery,['10.1001/jamasurg.2019.1163']
1364,31197506,Effects of a formula with a probiotic Bifidobacterium lactis Supplement on the gut microbiota of low birth weight infants.,"PURPOSE


Low birth weight (LBW) infants have a less diverse gut microbiota, enriched in potential pathogens, which places them at high risk of systemic inflammation diseases. This study aimed to identify the differences in gut bacterial community structure between LBW infants who received probiotics and LBW infants who did not receive probiotics.
METHODS


Forty-one infants were allocated to the non-probiotic group (N group) and 56 infants to the probiotic group (P group), according to whether the formula they received contained a probiotic Bifidobacterium lactis. Gut bacterial composition was identified with sequencing of the 16S rRNA gene in fecal samples collected at 14 days after birth.
RESULTS


There was no significant difference between the alpha diversity of the two groups, while the beta diversity was significantly different (p < 0.05). Our results showed that Bifidobacterium and Lactobacillus (both p < 0.05) were enriched in the P group, while Veillonella, Dolosigranulum and Clostridium sensu stricto 1 (all p < 0.05) were enriched in the N group. Predicted metagenome function analysis revealed enhancement of fatty acids, peroxisome, starch, alanine, tyrosine and peroxisome pathways in the P group, and enhancement of plant pathogen, Salmonella and Helicobacter pylori infection pathways in the N group.
CONCLUSIONS


Probiotic supplement in formula may affect the composition, stability and function of LBW infants' gut microbiota. LBW infants who receive probiotic intervention may benefit from gut microbiota that contains more beneficial bacteria.",2020,"Predicted metagenome function analysis revealed enhancement of fatty acids, peroxisome, starch, alanine, tyrosine and peroxisome pathways in the P group, and enhancement of plant pathogen, Salmonella and Helicobacter pylori infection pathways in the N group.
","['low birth weight infants', 'LBW infants who receive', 'Forty-one infants', 'LBW infants who received probiotics and LBW infants who did not receive probiotics']","['probiotic Bifidobacterium lactis', 'probiotic intervention', 'probiotic Bifidobacterium lactis Supplement']","['alpha diversity', 'enhancement of fatty acids, peroxisome, starch, alanine, tyrosine and peroxisome pathways', 'enhancement of plant pathogen, Salmonella and Helicobacter pylori infection pathways', 'Bifidobacterium and Lactobacillus', 'beta diversity']","[{'cui': 'C0021288', 'cui_str': 'Low Birth Weight Infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis subsp. lactis'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0752063'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0036111', 'cui_str': 'Salmonella'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]",41.0,0.036189,"Predicted metagenome function analysis revealed enhancement of fatty acids, peroxisome, starch, alanine, tyrosine and peroxisome pathways in the P group, and enhancement of plant pathogen, Salmonella and Helicobacter pylori infection pathways in the N group.
","[{'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Chi', 'Affiliation': 'Department of Internal Medicine, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, 100026, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Ruixia', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Central Laboratory, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, 100026, China.'}, {'ForeName': 'Yanxin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, 100026, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'CAS Key Laboratory of Pathogenic Microbiology and Immunology, Institute of Microbiology, Chinese Academy of Science, Beijing, 100101, China.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Department of Neonatology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, 100026, China.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Buys', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, 4222, Australia.'}, {'ForeName': 'Baoli', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'CAS Key Laboratory of Pathogenic Microbiology and Immunology, Institute of Microbiology, Chinese Academy of Science, Beijing, 100101, China. zhubaoli@im.ac.cn.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'School of Medicine, Griffith University, Gold Coast, QLD, 4222, Australia. j.sun@griffith.edu.au.'}, {'ForeName': 'Chenghong', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': 'Department of Internal Medicine, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, 100026, China. modscn@126.com.'}]",European journal of nutrition,['10.1007/s00394-019-02006-4']
1365,31177631,M-SAKHI-Mobile health solutions to help community providers promote maternal and infant nutrition and health using a community-based cluster randomized controlled trial in rural India: A study protocol.,"Reduction of childhood stunting is difficult to achieve by interventions that focus only on improving nutrition during infancy. Comprehensive interventions that extend through the continuum of care from pregnancy to infancy are needed. Mobile phones are now successfully being used for behaviour change communication to improve health. We present the methodology of an mHealth intervention ""Mobile Solutions Aiding Knowledge for Health Improvement"" (M-SAKHI) to be delivered by rural community health workers or Accredited Social Health Activists (ASHAs) for rural women, below or up to 20 weeks of pregnancy through delivery until their infant is 12 months of age. This protocol paper describes the cluster randomized controlled trial to evaluate the effectiveness of M-SAKHI. The primary objective of the trial is to reduce the prevalence of stunting (height-for-age < -2 z-score) in children at 18 months of age by 8% in the intervention as compared with control. The secondary objectives include evaluating the impact on maternal dietary diversity, birth weight, infant and young child feeding practices, infant development, and child morbidity, along with a range of intermediate outcomes for maternal, neonatal, and infant health. A total of 297 ASHAs, five trained counsellors, and 2,501 participants from 244 villages are participating in this study. The outcome data are being collected by 51 field research officers. This study will provide evidence regarding the efficacy of M-SAKHI to reduce stunting in young children in rural India, and if effective, the cost-effectiveness of M-SAKHI.",2019,"The secondary objectives include evaluating the impact on maternal dietary diversity, birth weight, infant and young child feeding practices, infant development, and child morbidity, along with a range of intermediate outcomes for maternal, neonatal, and infant health.","['young children in rural India', 'children at 18\xa0months of age by 8% in the intervention as compared with control', 'rural community health workers or Accredited Social Health Activists (ASHAs) for rural women, below or up to 20\xa0weeks of pregnancy through delivery until their infant is 12\xa0months of age', 'A total of 297 ASHAs, five trained counsellors, and 2,501 participants from 244 villages are participating in this study']",['M-SAKHI'],"['maternal dietary diversity, birth weight, infant and young child feeding practices, infant development, and child morbidity, along with a range of intermediate outcomes for maternal, neonatal, and infant health']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0205714', 'cui_str': 'Infant Development'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0205806', 'cui_str': 'Baby Health'}]",,0.110952,"The secondary objectives include evaluating the impact on maternal dietary diversity, birth weight, infant and young child feeding practices, infant development, and child morbidity, along with a range of intermediate outcomes for maternal, neonatal, and infant health.","[{'ForeName': 'Archana B', 'Initials': 'AB', 'LastName': 'Patel', 'Affiliation': 'Lata Medical Research Foundation, Nagpur, India.'}, {'ForeName': 'Priyanka N', 'Initials': 'PN', 'LastName': 'Kuhite', 'Affiliation': 'Lata Medical Research Foundation, Nagpur, India.'}, {'ForeName': 'Ashraful', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Yamini', 'Initials': 'Y', 'LastName': 'Pusdekar', 'Affiliation': 'Lata Medical Research Foundation, Nagpur, India.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Puranik', 'Affiliation': 'Lata Medical Research Foundation, Nagpur, India.'}, {'ForeName': 'Samreen Sadaf', 'Initials': 'SS', 'LastName': 'Khan', 'Affiliation': 'Lata Medical Research Foundation, Nagpur, India.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kelly', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sumithra', 'Initials': 'S', 'LastName': 'Muthayya', 'Affiliation': 'The Sax Institute, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Tracey-Lea', 'Initials': 'TL', 'LastName': 'Laba', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': ""Michelle D'"", 'Initials': 'M', 'LastName': 'Almeida', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dibley', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}]",Maternal & child nutrition,['10.1111/mcn.12850']
1366,31780765,Pharmacogenetics of amfepramone in healthy Mexican subjects reveals potential markers for tailoring pharmacotherapy of obesity: results of a randomised trial.,"Amfepramone (AFP) is an appetite-suppressant drug used in the treatment of obesity. Nonetheless, studies on interindividual pharmacokinetic variability and its association with genetic variants are limited. We employed a pharmacokinetic and pharmacogenetic approach to determine possible metabolic phenotypes of AFP and identify genetic markers that could affect the pharmacokinetic variability in a Mexican population. A controlled, randomized, crossover, single-blind, two-treatment, two-period, and two sequence clinical study of AFP (a single 75 mg dose) was conducted in 36 healthy Mexican volunteers who fulfilled the study requirements. Amfepramone plasma levels were measured using high-performance liquid chromatography mass spectrometry. Genotyping was performed using real-time PCR with TaqMan probes. Four AFP metabolizer phenotypes were found in our population: slow, normal, intermediate, and fast. Additionally, two gene polymorphisms, ABCB1-rs1045642 and CYP3A4-rs2242480, had a significant effect on AFP pharmacokinetics (P < 0.05) and were the predictor factors in a log-linear regression model. The ABCB1 and CYP3A4 gene polymorphisms were associated with a fast metabolizer phenotype. These results suggest that metabolism of AFP in the Mexican population is variable. In addition, the genetic variants ABCB1-rs1045642 and CYP3A4-rs2242480 may partially explain the AFP pharmacokinetic variability.",2019,The ABCB1 and CYP3A4 gene polymorphisms were associated with a fast metabolizer phenotype.,"['healthy Mexican subjects', 'Mexican population', '36 healthy Mexican volunteers who fulfilled the study requirements']","['AFP', 'amfepramone', 'Amfepramone (AFP']","['Amfepramone plasma levels', 'AFP pharmacokinetics']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0012201', 'cui_str': 'amfepramone'}]","[{'cui': 'C0012201', 'cui_str': 'amfepramone'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",36.0,0.0420168,The ABCB1 and CYP3A4 gene polymorphisms were associated with a fast metabolizer phenotype.,"[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Gómez-Silva', 'Affiliation': 'Forensic Medicine Service, School of Medicine, Autonomous University of Nuevo Leon, Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'Everardo', 'Initials': 'E', 'LastName': 'Piñeyro-Garza', 'Affiliation': 'Clinical Department of the Research Institute for Clinical and Experimental Pharmacology, Ipharma S.A, Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'Rigoberto', 'Initials': 'R', 'LastName': 'Vargas-Zapata', 'Affiliation': 'Quality Assurance Department of the Research Institute for Clinical and Experimental Pharmacology, Ipharma S.A, Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'María Elena', 'Initials': 'ME', 'LastName': 'Gamino-Peña', 'Affiliation': 'Statistical Department of the Research Institute for Clinical and Experimental Pharmacology, Ipharma S.A, Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'León-García', 'Affiliation': 'Pharmaceutical Research S.A, Mexico City, CDMX, Mexico.'}, {'ForeName': 'Mario Bermúdez', 'Initials': 'MB', 'LastName': 'de León', 'Affiliation': 'Department of Molecular Biology, Center for Biomedical Research of the Northeast, Mexican Institute of Social Security, Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Llerena', 'Affiliation': 'Clinical Research Center of Health Area, Hospital and Medical School of Extremadura University, Badajoz, Spain.'}, {'ForeName': 'Rafael B R', 'Initials': 'RBR', 'LastName': 'León-Cachón', 'Affiliation': 'Center of Molecular Diagnostics and Personalized Medicine, Department of Basic Sciences, Division of Health Sciences, University of Monterrey, San Pedro Garza Garcia, Nuevo Leon, Mexico. rafael.reyesleon@udem.edu.'}]",Scientific reports,['10.1038/s41598-019-54436-z']
1367,31684977,Implementation of a behavioral medicine approach in physiotherapy: a process evaluation of facilitation methods.,"BACKGROUND


In a quasi-experimental study, facilitation was used to support implementation of the behavioral medicine approach in physiotherapy. The facilitation consisted of an individually tailored multifaceted intervention including outreach visits, peer coaching, educational materials, individual goal-setting, video feedback, self-monitoring in a diary, manager support, and information leaflets to patients. A behavioral medicine approach implies a focus on health related behavior change. Clinical behavioral change was initiated but not maintained among the participating physiotherapists. To explain these findings, a deeper understanding of the implementation process is necessary. The aim was therefore to explore the impact mechanisms in the implementation of a behavioral medicine approach in physiotherapy by examining dose, reach, and participant experiences.
METHODS


An explorative mixed-methods design was used as a part of a quasi-experimental trial. Twenty four physiotherapists working in primary health care were included in the quasi-experimental trial, and all physiotherapists in the experimental group (n = 15) were included in the current study. A facilitation intervention based mainly on social cognitive theory was tested during a 6-month period. Data were collected during and after the implementation period by self-reports of time allocation regarding participation in different implementation methods, documentation of individual goals, ranking of the most important implementation methods, and semi-structured interviews. Descriptive statistical methods and inductive content analysis were used.
RESULTS


The physiotherapists participated most frequently in the following implementation methods: outreach visits, peer coaching, educational materials, and individual goal-setting. They also considered these methods to be the most important for implementation, contributing to support for learning, practice, memory, emotions, self-management, and time management. However, time management support from the manager was lacking.
CONCLUSIONS


The findings indicate that different mechanisms govern the initiation and maintenance of clinical behavior change. The impact mechanisms for initiation of clinical behavior change refers to the use of externally initiated multiple methods, such as feedback on practice, time management, and extrinsic motivation. The lack of self-regulation capability, intrinsic motivation, and continued support after the implementation intervention period were interpreted as possible mechanisms for the failure of maintaining the behavioral change over time.",2019,"The physiotherapists participated most frequently in the following implementation methods: outreach visits, peer coaching, educational materials, and individual goal-setting.","['Twenty four physiotherapists working in primary health care were included in the quasi-experimental trial, and all physiotherapists in the experimental group (n\u2009=\u200915) were included in the current study', 'physiotherapy']","['individually tailored multifaceted intervention including outreach visits, peer coaching, educational materials, individual goal-setting, video feedback, self-monitoring', 'behavioral medicine approach']",['Clinical behavioral change'],"[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0004937', 'cui_str': 'Behavioral Medicine'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0247957,"The physiotherapists participated most frequently in the following implementation methods: outreach visits, peer coaching, educational materials, and individual goal-setting.","[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Fritz', 'Affiliation': 'School of Health, Care and Social Welfare, Mälardalen University, Box 883, SE-721 23, Västerås, Sweden. johanna.fritz@mdh.se.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallin', 'Affiliation': 'School of Education, Health and Social Studies, Dalarna University, Falun, Sweden.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Söderlund', 'Affiliation': 'School of Health, Care and Social Welfare, Mälardalen University, Box 883, SE-721 23, Västerås, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Almqvist', 'Affiliation': 'School of Health, Care and Social Welfare, Mälardalen University, Box 883, SE-721 23, Västerås, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sandborgh', 'Affiliation': 'School of Health, Care and Social Welfare, Mälardalen University, Box 883, SE-721 23, Västerås, Sweden.'}]",Implementation science : IS,['10.1186/s13012-019-0942-y']
1368,31194645,Improving Supply Chain for Essential Drugs in Low-Income Countries: Results from a Large Scale Randomized Experiment in Zambia.,"Despite increased investments in procurement of essential medicines, their availability at health facilities remains extremely low in many low- and middle-income countries. The lack of a well-functioning supply chain for essential medicines is often the cause of this poor availability. Using a randomized trial conducted in 439 health facilities and 24 districts in Zambia, this study helps understand the optimal supply chain structure for essential medicines distribution in the public sector in low-income countries. It shows that a more direct distribution system where clinics order and receive medicines supply directly from the central agency through a cross-docking arrangement significantly reduces the duration and frequency of stockouts compared to a traditional three-level drug distribution system. As an example, the frequency of stockouts for first line pediatric malaria medicines reduced from 47.9% to 13.3% and the number of days of stockout in a quarter reduced from 27 days to 5 days. The direct flow of demand and order information from health facilities to the central supply agency reduces the problem of diffuse accountability that exists in multi-tiered distribution systems. It also shifts the locus of decision making for complex supply chain functions such as scarce stock allocation and adjustment of health facility order quantities to levels in the system where staff competency is aligned with what the function needs. Even when supply chain system redesign such as the one evaluated in this paper are demonstrated to be technically robust using rigorous evidence, they often require navigating a complex political economy within the overall health system and its actors.",2019,It also shifts the locus of decision making for complex supply chain functions such as scarce stock allocation and adjustment of health facility order quantities to levels in the system where staff competency is aligned with what the function needs.,"['Low-Income Countries', '439 health facilities and 24 districts in Zambia']",[],['duration and frequency of stockouts'],"[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}]",[],"[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.0368209,It also shifts the locus of decision making for complex supply chain functions such as scarce stock allocation and adjustment of health facility order quantities to levels in the system where staff competency is aligned with what the function needs.,"[{'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Vledder', 'Affiliation': 'a GFF Secretariat , World Bank , Washington , DC , USA.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Friedman', 'Affiliation': 'b Development Research Group , World Bank , Washington , DC , USA.'}, {'ForeName': 'Mirja', 'Initials': 'M', 'LastName': 'Sjöblom', 'Affiliation': 'a GFF Secretariat , World Bank , Washington , DC , USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Brown', 'Affiliation': 'd Supply Chain , Bill & Melinda Gates Foundation , Seattle , WA , USA.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Yadav', 'Affiliation': 'e Department of Global Health and Social Medicine , Harvard Medical School , Boston , MA , USA.'}]",Health systems and reform,['10.1080/23288604.2019.1596050']
1369,31387756,Hyperthermic intraperitoneal chemotherapy in serosa-invasive gastric cancer patients.,"BACKGROUND


Evaluation of hyperthermic intraperitoneal chemotherapy (HIPEC) in reducing metachronous peritoneal metastases (MPM) risks in patients with resectable serosa-invasive gastric cancer.
MATERIALS & METHODS


Between 2008 and 2016, 154 patients with gastric cancer (stage IIB-IIIC) were randomly assigned to two groups: 76 patients underwent HIPEC (cisplatin 50 mg/m 2  + doxorubicin 50 mg/m 2 , 42 °C, 1 h) combined with radical surgery (HIPEC group) and 78 patients underwent only radical surgery (control group).
RESULTS


Evaluation of HIPEC toxicity showed neither toxic complications of IV-V degree nor haematological toxicity (according to CTCAE v. 4.03). There was no significant difference in the rate of complications between the two groups (p = 0.254). There was a more frequent disease progression in the control group than in the HIPEC group: 42/55 patients (76.4%) vs. 36/68 patients (52.9%), respectively (p = 0.009). At the same time a significant decrease in the rate of MPM was observed after HIPEC administration as compared with surgery alone - 16/68 (12.8%) vs. 39/55 (27.6%) (p < 0.001). 3-year progression-free survival was 47% (95% CI 36-61)) in the HIPEC group and 27% (95% CI 17-43) in the control group - p = 0.0024. The N-stage, HIPEC procedure, type of surgery and interaction between HIPEC treatment and age were independent prognostic factors.
CONCLUSIONS


HIPEC appears to be helpful in improving treatment results in radically operated gastric cancer patients.",2019,3-year progression-free survival was 47% (95% CI 36-61)) in the HIPEC group and 27% (95% CI 17-43) in the control group - p = 0.0024.,"['Between 2008 and 2016', 'patients with resectable serosa-invasive gastric cancer', 'radically operated gastric cancer patients', '154 patients with gastric cancer (stage IIB-IIIC', 'serosa-invasive gastric cancer patients']","['Hyperthermic intraperitoneal chemotherapy', '\xa0doxorubicin 50', 'HIPEC', 'radical surgery (HIPEC group) and 78 patients underwent only radical surgery (control group', 'hyperthermic intraperitoneal chemotherapy (HIPEC', 'HIPEC (cisplatin 50']","['rate of complications', 'frequent disease progression', '3-year progression-free survival', 'toxic complications of IV-V degree nor haematological toxicity', 'rate of MPM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036760', 'cui_str': 'Serosa'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B (qualifier value)'}]","[{'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1742123', 'cui_str': '(11C)MPM'}]",154.0,0.0363659,3-year progression-free survival was 47% (95% CI 36-61)) in the HIPEC group and 27% (95% CI 17-43) in the control group - p = 0.0024.,"[{'ForeName': 'M Yu', 'Initials': 'MY', 'LastName': 'Reutovich', 'Affiliation': 'Gastroesophageal Pathology Departement, N.N. Alexandrov National Cancer Center, Minsk, Belarus. Electronic address: mihail_revtovich@yahoo.com.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Krasko', 'Affiliation': 'United Institute of Informatics Problems, National Academy of Sciences, Minsk, Belarus.'}, {'ForeName': 'O G', 'Initials': 'OG', 'LastName': 'Sukonko', 'Affiliation': 'Gastroesophageal Pathology Departement, N.N. Alexandrov National Cancer Center, Minsk, Belarus.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2019.07.030']
1370,31706329,Investigation of factors influencing the implementation of two shared decision-making interventions in contraceptive care: a qualitative interview study among clinical and administrative staff.,"BACKGROUND


There is limited evidence on how to implement shared decision-making (SDM) interventions in routine practice. We conducted a qualitative study, embedded within a 2 × 2 factorial cluster randomized controlled trial, to assess the acceptability and feasibility of two interventions for facilitating SDM about contraceptive methods in primary care and family planning clinics. The two SDM interventions comprised a patient-targeted intervention (video and prompt card) and a provider-targeted intervention (encounter decision aids and training).
METHODS


Participants were clinical and administrative staff aged 18 years or older who worked in one of the 12 clinics in the intervention arm, had email access, and consented to being audio-recorded. Semi-structured telephone interviews were conducted upon completion of the trial. Audio recordings were transcribed verbatim. Data collection and thematic analysis were informed by the 14 domains of the Theoretical Domains Framework, which are relevant to the successful implementation of provider behaviour change interventions.
RESULTS


Interviews (n = 29) indicated that the interventions were not systematically implemented in the majority of clinics. Participants felt the interventions were aligned with their role and they had confidence in their skills to use the decision aids. However, the novelty of the interventions, especially a need to modify workflows and change behavior to use them with patients, were implementation challenges. The interventions were not deeply embedded in clinic routines and their use was threatened by lack of understanding of their purpose and effect, and staff absence or turnover. Participants from clinics that had an enthusiastic study champion or team-based organizational culture found these social supports had a positive role in implementing the interventions.
CONCLUSIONS


Variation in capabilities and motivation among clinical and administrative staff, coupled with inconsistent use of the interventions in routine workflow contributed to suboptimal implementation of the interventions. Future trials may benefit by using implementation strategies that embed SDM in the organizational culture of clinical settings.",2019,"The interventions were not deeply embedded in clinic routines and their use was threatened by lack of understanding of their purpose and effect, and staff absence or turnover.","['primary care and family planning clinics', 'Participants from clinics that had an enthusiastic study champion or team-based organizational culture', 'contraceptive care', 'Participants were clinical and administrative staff aged 18\xa0years or older who worked in one of the 12 clinics in the intervention arm, had email access, and consented to being audio-recorded']",['patient-targeted intervention (video and prompt card) and a provider-targeted intervention (encounter decision aids and training'],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3840184', 'cui_str': 'Family planning clinic'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0558083', 'cui_str': 'Enthusiastic (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029242', 'cui_str': 'Corporate Culture'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],,0.0469974,"The interventions were not deeply embedded in clinic routines and their use was threatened by lack of understanding of their purpose and effect, and staff absence or turnover.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Munro', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, E204 - 4500 Oak Street, Vancouver, BC, V6H 3N1, Canada. sarah.munro@ubc.ca.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Manski', 'Affiliation': 'Society of Family Planning, 225 South 17th Street, Suite 2709, Philadelphia, PA, 19103, USA.'}, {'ForeName': 'Kyla Z', 'Initials': 'KZ', 'LastName': 'Donnelly', 'Affiliation': 'Dartmouth College, Level 5 Williamson Translational Research Building, One Medical Center Drive, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Agusti', 'Affiliation': 'Dartmouth College Health Service, 7 Rope Ferry Rd, Hanover, NH, 03755, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Stevens', 'Affiliation': 'Dartmouth College, Level 5 Williamson Translational Research Building, One Medical Center Drive, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Banach', 'Affiliation': 'Patient Partner, Tyrone, NY, USA.'}, {'ForeName': 'Maureen B', 'Initials': 'MB', 'LastName': 'Boardman', 'Affiliation': 'Dartmouth College, Level 5 Williamson Translational Research Building, One Medical Center Drive, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Pearl', 'Initials': 'P', 'LastName': 'Brady', 'Affiliation': 'Patient Partner, New York, NY, USA.'}, {'ForeName': 'Chrissy Colón', 'Initials': 'CC', 'LastName': 'Bradt', 'Affiliation': 'Patient Partner, Greenwich, CT, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Foster', 'Affiliation': 'Dartmouth College, Level 5 Williamson Translational Research Building, One Medical Center Drive, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Johnson', 'Affiliation': 'Dartmouth College, Level 5 Williamson Translational Research Building, One Medical Center Drive, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Norsigian', 'Affiliation': 'Our Bodies Ourselves, P.O. Box 590403, Newton Center, MA, 02459, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Nothnagle', 'Affiliation': 'Department of Family and Community Medicine, University of California San Francisco, Natividad Medical Center, 1441 Constitution Blvd, Salinas, CA, 93906, USA.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Shepherd', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Edward Ford Building (A27), Fisher Road, Camperdown, NSW, 2006, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Stern', 'Affiliation': 'Planned Parenthood Northern California, 2185 Pacheco St, Concord, CA, 94520, USA.'}, {'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Trevena', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Edward Ford Building (A27), Fisher Road, Camperdown, NSW, 2006, Australia.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Elwyn', 'Affiliation': 'Dartmouth College, Level 5 Williamson Translational Research Building, One Medical Center Drive, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Thompson', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Edward Ford Building (A27), Fisher Road, Camperdown, NSW, 2006, Australia.'}]",Implementation science : IS,['10.1186/s13012-019-0941-z']
1371,31669447,Serum 25-hydroxyvitamin D in the VITamin D and OmegA-3 TriaL (VITAL): Clinical and demographic characteristics associated with baseline and change with randomized vitamin D treatment.,"BACKGROUND


The VITamin D and OmegA-3 TriaL (VITAL) is a completed randomized, placebo-controlled trial of vitamin D 3  (2000 IU/day) and marine omega-3 (1 g/day) supplements in the primary prevention of cancer and cardiovascular disease. Here we examine baseline and change in 25-hydroxyvitamin D (25(OH)D) and related biomarkers with randomized treatment and by clinical factors.
METHODS


Baseline 25(OH)D was measured in 15,804 participants (mean age 68 years.; 50.8% women; 15.7% African Americans) and in 1660 1-year follow-up samples using liquid chromatography-tandem mass spectrometry and chemiluminescence. Calcium and parathyroid hormone (iPTH) were measured by chemiluminescence and spectrophotometry respectively.
RESULTS


Mean baseline total 25(OH)D (ng/mL ± SD) was 30.8 ± 10.0 ng/mL, and correlated inversely with iPTH (r = -0.28), p < .001. After adjusting for clinical factors, 25(OH)D (ng/mL ± SE) was lower in men vs women (29.7 ± 0.30 vs 31.4 ± 0.30, p < .0001) and in African Americans vs whites (27.9 ± 0.29 vs 32.5 ± 0.22, p < .0001). It was also lower with increasing BMI, smoking, and latitude, and varied by season. Mean 1-year 25(OH)D increased by 11.9 ng/mL in the active group and decreased by 0.7 ng/mL in placebo. The largest increases were noted among individuals with low baseline and African Americans. Results were similar for chemiluminescent immunoassay. Mean calcium was unchanged, and iPTH decreased with treatment.
CONCLUSION


In VITAL, baseline 25(OH)D varied by clinical subgroups, was lower in men and African Americans. Concentrations increased with vitamin D supplementation, with the greatest increases in those with lower baseline 25(OH)D. The seasonal trends in 25(OH)D, iPTH, and calcium may be relevant when interpreting 25(OH)D levels for clinical treatment decisions.
CLINICAL TRIAL REGISTRATION


VITAL ClinicalTrials.gov number NCT01169259.",2019,Mean 1-year 25(OH)D increased by 11.9 ng/mL in the active group and decreased by 0.7 ng/mL in placebo.,"['15,804 participants (mean age 68\u202fyears', 'number', 'individuals with low baseline and African Americans']","['vitamin D supplementation', 'placebo', 'marine omega-3', 'VITamin D and OmegA-3 TriaL', 'vitamin D']","['total 25(OH)D (ng/mL\u202f±\u202fSD', 'BMI, smoking, and latitude, and varied by season', 'Mean 1-year 25(OH)D', 'Calcium and parathyroid hormone (iPTH', '25-hydroxyvitamin D (25(OH)D', 'Serum 25-hydroxyvitamin D', 'Mean calcium']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.470621,Mean 1-year 25(OH)D increased by 11.9 ng/mL in the active group and decreased by 0.7 ng/mL in placebo.,"[{'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Luttmann-Gibson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Environmental Health, Harvard T.H. Chan School of Public Health, Landmark Center West, 401 Park Drive, Boston, MA 02215, USA.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Division of Cardiovascular Medicine and Center for Lipid Metabolomics, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA. Electronic address: smora@bwh.harvard.edu.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA; Channing Division of Network Medicine, Department of Medicine, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.'}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Demler', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Ghoshal', 'Affiliation': 'Quest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Wohlgemuth', 'Affiliation': 'Quest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Kulkarni', 'Affiliation': 'Atherotech Diagnostics, 201 London Pkwy #400, Birmingham, AL 35211, USA; VAP Diagnostics R&D Laboratory, 201 London Pkwy, Birmingham, AL 3521, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Larsen', 'Affiliation': 'Quest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prentice', 'Affiliation': 'Quest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cobble', 'Affiliation': 'Atherotech Diagnostics, 201 London Pkwy #400, Birmingham, AL 35211, USA.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Chunying', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Friedenberg', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2019.105854']
1372,30216294,Congenital Cytomegalovirus and HIV Perinatal Transmission.,"BACKGROUND


Congenital cytomegalovirus (CMV) infection (cCMV) is an important cause of hearing loss and cognitive impairment. Prior studies suggest that HIV-exposed children are at higher risk of acquiring cCMV. We assessed the presence, magnitude and risk factors associated with cCMV among infants born to HIV-infected women, who were not receiving antiretrovirals during pregnancy.
METHODS


cCMV and urinary CMV load were determined in a cohort of infants born to HIV-infected women not receiving antiretrovirals during pregnancy. Neonatal urines obtained at birth were tested for CMV DNA by qualitative and reflex quantitative real-time polymerase chain reaction.
RESULTS


Urine specimens were available for 992 (58.9%) of 1684 infants; 64 (6.5%) were CMV-positive. Mean CMV load (VL) was 470,276 copies/ml (range: < 200-2,000,000 copies/ml). Among 89 HIV-infected infants, 16 (18%) had cCMV versus 42 (4.9%) of 858 HIV-exposed, uninfected infants (P < 0.0001). cCMV was present in 23.2% of infants with in utero and 9.1% infants with intrapartum HIV infection (P < 0.0001). Rates of cCMV among HIV-infected infants were 4-fold greater (adjusted OR, 4.4; 95% CI: 2.3-8.2) and 6-fold greater among HIV in utero-infected infants (adjusted OR, 6; 95% CI: 3-12.1) compared with HIV-exposed, uninfected infants. cCMV was not associated with mode of delivery, gestational age, Apgar scores, 6-month infant mortality, maternal age, race/ethnicity, HIV viral load or CD4 count. Primary cCMV risk factors included infant HIV-infection, particularly in utero infection.
CONCLUSION


High rates of cCMV with high urinary CMV VL were observed in HIV-exposed infants. In utero HIV infection appears to be a major risk factor for cCMV in infants whose mothers have not received combination antiretroviral therapy in pregnancy.",2018,"cCMV was not associated with mode of delivery, gestational age, Apgar scores, 6-month infant mortality, maternal age, race/ethnicity, HIV viral load or CD4 count.","['infants born to HIV-infected women, who were not receiving antiretrovirals during pregnancy', 'infants born to HIV-infected women not receiving antiretrovirals during pregnancy']",[],"['Mean CMV load (VL', 'cCMV', 'Rates of cCMV', 'infant HIV-infection, particularly in utero infection', 'mode of delivery, gestational age, Apgar scores, 6-month infant mortality, maternal age, race/ethnicity, HIV viral load or CD4 count', 'urinary CMV load']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0021278', 'cui_str': 'Infant Mortality'}, {'cui': 'C0024915', 'cui_str': 'Maternal Age'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}]",,0.0864699,"cCMV was not associated with mode of delivery, gestational age, Apgar scores, 6-month infant mortality, maternal age, race/ethnicity, HIV viral load or CD4 count.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Adachi', 'Affiliation': 'From the David Geffen UCLA School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Jiahong', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Westat, Rockville, MD.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Ank', 'Affiliation': 'From the David Geffen UCLA School of Medicine, Los Angeles, CA.'}, {'ForeName': 'D Heather', 'Initials': 'DH', 'LastName': 'Watts', 'Affiliation': 'Office of the Global AIDS Coordinator, U.S. Department of State, Washington, DC.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Camarca', 'Affiliation': 'Westat, Rockville, MD.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Mofenson', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Jose Henrique', 'Initials': 'JH', 'LastName': 'Pilotto', 'Affiliation': 'Hospital Geral de Nova Iguaçu, Nova Iguaçu, RJ, Brazil.'}, {'ForeName': 'Esau', 'Initials': 'E', 'LastName': 'Joao', 'Affiliation': 'Hospital Federal dos Servidores do Estado, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Gray', 'Affiliation': 'SAMRC and Perinatal HIV Research Unit, University of Witwatersrand, Cape Town, South Africa.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'Stellenbosch University/Tygerberg Hospital, Cape Town, South Africa.'}, {'ForeName': 'Breno', 'Initials': 'B', 'LastName': 'Santos', 'Affiliation': 'Hospital Conceicao, Porto Alegre, RS, BrazilHospital Femina, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Fonseca', 'Affiliation': ''}, {'ForeName': 'Regis', 'Initials': 'R', 'LastName': 'Kreitchmann', 'Affiliation': 'Irmandade da Santa Casa de Misericordia de Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Pinto', 'Affiliation': 'Federal University of Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Marisa M', 'Initials': 'MM', 'LastName': 'Mussi-Pinhata', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, SP, Brazil.'}, {'ForeName': 'Daisy Maria', 'Initials': 'DM', 'LastName': 'Machado', 'Affiliation': 'Escola Paulista de Medicina-Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Ceriotto', 'Affiliation': 'Foundation for Maternal and Infant Health (FUNDASAMIN), Buenos Aires, Argentina.'}, {'ForeName': 'Mariza G', 'Initials': 'MG', 'LastName': 'Morgado', 'Affiliation': 'Fundacao Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Yvonne J', 'Initials': 'YJ', 'LastName': 'Bryson', 'Affiliation': 'From the David Geffen UCLA School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Valdilea G', 'Initials': 'VG', 'LastName': 'Veloso', 'Affiliation': 'Fundacao Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'Fundacao Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mirochnick', 'Affiliation': 'Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Moye', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nielsen-Saines', 'Affiliation': 'From the David Geffen UCLA School of Medicine, Los Angeles, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000001975']
1373,31731006,A pilot multisite study of patient navigation for pregnant women with opioid use disorder.,"The opioid crisis continues to affect pregnant and postpartum women the United States, with the number of pregnant women diagnosed with opioid use disorder (OUD) quadrupling over the last decade. The associated increase in morbidity and mortality among mother and baby warrants prompt, targeted intervention efforts that improve engagement, linkage of care, and treatment retention. Patient navigation (PN) is a chronic care intervention that can directly address this need by helping women identify medical, behavioral, and psychosocial care goals. Moreover, PN can assist women in preparing for, engaging in, and maintaining patient participation in necessary services. Specifically, PN includes strengths-based case management, 1-1 clinical support, motivational interviewing, and addiction-relapse prevention programming. The objective of this article is to present the study protocol of a pilot multisite randomized clinical trial, entitled: Optimizing Pregnancy and Treatment Interventions for Moms 2.0 (OPTI-Mom 2.0; NCT03833245). In this study, we build upon a proof-of-concept study, employing evidence-informed frameworks for protocol and intervention expansion in order to construct a PN intervention tailored for pregnant women with OUD in central Utah and southwestern Pennsylvania. Our protocol provides an initial framework of a potentially impactful intervention and may guide development of future programs. Importantly, this study further establishes the evidence-base-with potential to ameliorate serious adverse opioid-related outcomes and improve health for women and their children.",2019,"The opioid crisis continues to affect pregnant and postpartum women the United States, with the number of pregnant women diagnosed with opioid use disorder (OUD) quadrupling over the last decade.","['pregnant women with OUD in central Utah and southwestern Pennsylvania', 'pregnant women with opioid use disorder']","['patient navigation', 'Patient navigation (PN']",['morbidity and mortality'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0042124', 'cui_str': 'Utah'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0451756,"The opioid crisis continues to affect pregnant and postpartum women the United States, with the number of pregnant women diagnosed with opioid use disorder (OUD) quadrupling over the last decade.","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Cochran', 'Affiliation': 'Program for Addiction Research, Clinical Care, Knowledge and Advocacy (PARCKA), Division of Epidemiology, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT, United States; Informatics, Decision-Enhancement, and Analytic Sciences Center, VA Salt Lake City Health Care System, Salt Lake City, UT, United States. Electronic address: jerry.cochran@hsc.utah.edu.'}, {'ForeName': 'Marcela C', 'Initials': 'MC', 'LastName': 'Smid', 'Affiliation': 'Department of Maternal Fetal Medicine, University of Utah School of Medicine, 30 N 1900 E, Salt Lake City, UT, United States.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Krans', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Womens Research Institute, 300 Halket Street, Pittsburgh, PA, United States.'}, {'ForeName': 'M Aryana', 'Initials': 'MA', 'LastName': 'Bryan', 'Affiliation': 'Program for Addiction Research, Clinical Care, Knowledge and Advocacy (PARCKA), Division of Epidemiology, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT, United States; University of Utah College of Social Work, 395 S 1500 E #111, Salt Lake City, UT, United States.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Gordon', 'Affiliation': 'Program for Addiction Research, Clinical Care, Knowledge and Advocacy (PARCKA), Division of Epidemiology, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, UT, United States; Informatics, Decision-Enhancement, and Analytic Sciences Center, VA Salt Lake City Health Care System, Salt Lake City, UT, United States.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Lundahl', 'Affiliation': 'University of Utah College of Social Work, 395 S 1500 E #111, Salt Lake City, UT, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Silipigni', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Womens Research Institute, 300 Halket Street, Pittsburgh, PA, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Haaland', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine 30 N 1900 E, Salt Lake City, UT, United States.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Tarter', 'Affiliation': 'University of Pittsburgh School of Pharmacy, 3501 Terrace St, Pittsburgh, PA, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105888']
1374,31188278,"Type-specific HPV prevalence, incident cases, persistence and associated pregnancy outcomes among HIV-infected women in Kenya.","BACKGROUND


Persistent infection with high-risk types of human papillomavirus (HPV) is the pre-eminent factor driving the development of cervical cancer. There are large gaps in knowledge about both the role of pregnancy in the natural history of HPV infection, and the impact of HPV on pregnancy outcomes.
METHODS


This single-site prospective cohort sub-study, nested within an international multi-site randomized controlled trial, assessed prevalence, incident cases and persistence of type-specific HPV infection, and the association between persistence of high-risk HPV infection with pregnancy outcomes among HIV-infected pregnant women in Kenya, including HIV transmission to infants. Type-specific HPV was assessed using a line probe assay in pregnancy and again at 3 months after delivery. HIV status of children was determined using PCR at 6 weeks.
RESULTS


In total, 84.1% of women (206/245) had a high-risk HPV infection at enrolment. Three quarters of these infections persisted postpartum (157/206). Persistence of HPV16 and/or HPV18 types was observed in over half (53.4%; 39/73) of women with this infection at enrolment. Almost two-thirds had an incident high-risk HPV infection postpartum, which was not present in pregnancy (62.5%), most commonly HPV52 (19.0%). After adjustments, no association was detected between persistent high-risk HPV and preterm birth. All mothers of the seven cases of infant HIV infection had persistent HR-HPV infection (P=0.044).
CONCLUSIONS


High levels of high-risk HPV infection and type-specific persistence were documented, heightening the urgency of mass role out of HPV vaccination. The association between HPV persistence and HIV transmission is a novel finding, warranting further study.",2019,"All mothers of the seven cases of infant HIV infection had persistent HR-HPV infection (P=0.044).
","['HIV-infected pregnant women in Kenya, including HIV transmission to infants', 'HIV-infected women in Kenya']",['HPV16'],"['persistent high-risk HPV and preterm birth', 'incident high-risk HPV infection postpartum', 'persistent HR-HPV infection', 'high-risk HPV infection']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]",,0.164114,"All mothers of the seven cases of infant HIV infection had persistent HR-HPV infection (P=0.044).
","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Vyankandondera', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Wambua', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Irungu', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Kishor', 'Initials': 'K', 'LastName': 'Mandaliya', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Temmerman', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Mohamed', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Davy', 'Initials': 'D', 'LastName': 'Vanden Broeck', 'Affiliation': 'International Centre for Reproductive Health, Department of Public Health and Primary Care, Ghent University, Belgium.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Verhelst', 'Affiliation': 'Ghent University, Belgium.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Chersich', 'Affiliation': 'International Centre for Reproductive Health, Department of Public Health and Primary Care, Ghent University, Belgium.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Luchters', 'Affiliation': 'Burnet Institute, Melbourne, Australia.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001029']
1375,32410485,"Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes: Insights From the PEGASUS-TIMI 54 Trial.","Background A proposed cause of dyspnea induced by ticagrelor is an increase in adenosine blood levels. Because caffeine is an adenosine antagonist, it can potentially improve drug tolerability with regard to dyspnea. Furthermore, association between caffeine and cardiovascular events is of clinical interest. Methods and Results This prespecified analysis used data from the PEGASUS TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54) trial, which randomized 21 162 patients with prior myocardial infarction to ticagrelor 60 mg or 90 mg or matching placebo (twice daily). Baseline caffeine intake in cups per week was prospectively collected for 9694 patients. Outcomes of interest included dyspnea, major adverse cardiovascular events (ie, the composite of cardiovascular death, myocardial infarction, or stroke), and arrhythmias. Dyspnea analyses considered the pooled ticagrelor group, whereas cardiovascular outcome analyses included patients from the 3 randomized arms. After adjustment, caffeine intake, compared with no intake, was not associated with lower rates of dyspnea in patients taking ticagrelor (adjusted hazard ratio (HR), 0.91; 95% CI, 0.76-1.10;  P =0.34). There was no excess risk with caffeine for major adverse cardiovascular events (adjusted HR, 0.78; 95% CI, 0.63-0.98;  P =0.031), sudden cardiac death (adjusted HR, 0.98; 95% CI, 0.57-1.70;  P =0.95), or atrial fibrillation (adjusted odds ratio, 1.07; 95% CI, 0.56-2.04;  P =0.84). Conclusions In patients taking ticagrelor for secondary prevention after myocardial infarction, caffeine intake at baseline was not associated with lower rates of dyspnea compared with no intake. Otherwise, caffeine appeared to be safe in this population, with no apparent increase in atherothrombotic events or clinically significant arrhythmias. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT01225562.",2020,"There was no excess risk with caffeine for major adverse cardiovascular events (adjusted HR, 0.78; 95% CI, 0.63-0.98;  P =0.031), sudden cardiac death (adjusted HR, 0.98; 95% CI, 0.57-1.70;  P =0.95), or atrial fibrillation (adjusted odds ratio, 1.07; 95% CI, 0.56-2.04;  P =0.84).","['9694 patients', 'Patients With Prior Heart Attack Using', '162 patients with prior myocardial infarction to']","['Ticagrelor', 'Placebo', 'Aspirin-Thrombolysis', 'caffeine', 'ticagrelor 60\xa0mg or 90\xa0mg or matching placebo', 'ticagrelor']","['dyspnea, major adverse cardiovascular events (ie, the composite of cardiovascular death, myocardial infarction, or stroke), and arrhythmias', 'Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes', 'atrial fibrillation', 'major adverse cardiovascular events', 'rates of dyspnea', 'atherothrombotic events', 'sudden cardiac death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C5191360', 'cui_str': '162'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C4051377', 'cui_str': 'Ticagrelor 60 MG'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}]",21162.0,0.16121,"There was no excess risk with caffeine for major adverse cardiovascular events (adjusted HR, 0.78; 95% CI, 0.63-0.98;  P =0.031), sudden cardiac death (adjusted HR, 0.98; 95% CI, 0.57-1.70;  P =0.95), or atrial fibrillation (adjusted odds ratio, 1.07; 95% CI, 0.56-2.04;  P =0.84).","[{'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Ramkumar V', 'Initials': 'RV', 'LastName': 'Venkateswaran', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor) Hospital das Clinicas da Faculdade de Medicina Universidade de Sao Paulo Brazil.'}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'University of Sheffield United Kingdom.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, and Assistance Publique-Hôpitaux de Paris Paris France.'}, {'ForeName': 'Giuglia', 'Initials': 'G', 'LastName': 'Magnani', 'Affiliation': 'University Hospital of Parma Italy.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Goto', 'Affiliation': 'Department of Medicine (Cardiology) Tokai University Hospital Isehara Japan.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Dellborg', 'Affiliation': 'Sahlgrenska Academy University of Gothenburg Sweden.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Kamensky', 'Affiliation': 'Department of Non-invasive Cardiovascular Diagnostics University Hospital Bratislava Bratislava Slovakia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Isaza', 'Affiliation': 'Fundacion Cardioinfantil Instituto de Cardiologia Bogotá Colombia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Aylward', 'Affiliation': 'South Australian Health and Medical Research Institute Flinders University and Medical Centre Adelaide Australia.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca Mölndal Sweden.'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.015785']
1376,31667571,"Neonatologists and non-vigorous newborns with meconium-stained amniotic fluid (MSAF) in the delivery room: time for hands off? : Comment on: Kumar A, Kumar P, Basu S. ""Endotracheal Suctioning for Prevention of Meconium Aspiration Syndrome: A Randomized Controlled Trial."" European Journal of Pediatrics 2019.",,2019,,['Meconium Aspiration Syndrome'],"['meconium-stained amniotic fluid (MSAF', 'Kumar A, Kumar P, Basu S. ""Endotracheal Suctioning']",[],"[{'cui': 'C0025048', 'cui_str': 'Meconium Aspiration Syndrome'}]","[{'cui': 'C0426209', 'cui_str': 'Amniotic fluid -meconium stain (finding)'}]",[],,0.0925315,,"[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Lista', 'Affiliation': 'Department of Pediatrics, NICU-Ospedale dei Bambini ""V.Buzzi""-ASST-FBF-Sacco, Milan, Italy. gianluca.lista@asst-fbf-sacco.it.'}]",European journal of pediatrics,['10.1007/s00431-019-03501-w']
1377,31537443,"Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials.","BACKGROUND


Herpes zoster (HZ) risk appears to vary by sex and geographic ancestry/ethnicity.
METHODS


In 2 randomized clinical trials, participants received 2 doses of adjuvanted recombinant zoster vaccine (RZV) or placebo intramuscularly, 2 months apart. In this post-hoc analysis, we investigate efficacy of RZV against HZ and postherpetic neuralgia (PHN) by sex, geographic region, and geographic ancestry/ethnicity in ≥50-year-olds (ZOE-50: NCT01165177) and ≥70-year-olds (pooled data from ZOE-50 and ZOE-70: NCT01165229).
RESULTS


Vaccine efficacy against HZ or PHN was similar in women and men. Across geographic regions, efficacy against HZ ranged between 95.7 and 97.2% in ≥50-year-olds, and between 87.3% and 95.1% in ≥70-year-olds; efficacy against PHN ranged between 86.8 and 100% in ≥70-year-olds. Across ancestral/ethnic groups, efficacy ranged between 88.1 and 100% against HZ and between 65.9 and 100% against PHN in ≥70-year-olds.
CONCLUSIONS


While the ZOE-50/70 studies were not powered or pre-designed for these post-hoc analyses, RZV appears efficacious against HZ and PHN irrespective of sex, region, or geographic ancestry/ethnicity.",2019,"In 2 randomized clinical trials, participants received 2 doses of adjuvanted recombinant zoster vaccine (RZV) or placebo intramuscularly, 2 months apart.",['women and men'],"['adjuvanted recombinant zoster vaccine (RZV', 'RZV', 'adjuvanted recombinant zoster vaccine (RZV) or placebo']",['efficacy against HZ'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.298751,"In 2 randomized clinical trials, participants received 2 doses of adjuvanted recombinant zoster vaccine (RZV) or placebo intramuscularly, 2 months apart.","[{'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Willer', 'Affiliation': 'GSK, 7333 Mississauga Rd., Mississauga, Ontario, Canada. Electronic address: david.o.willer@gsk.com.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: cornelia.oostvogels@orange.fr.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Cunningham', 'Affiliation': 'The Westmead Institute for Medical Research, 176 Hawkesbury Rd, Westmead, NSW 2145, Australia; University of Sydney, 133 Castlereagh St, Sydney, NSW 2000, Australia. Electronic address: tony.cunningham@sydney.edu.au.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gervais', 'Affiliation': 'Q&T Research Sherbrooke Inc, 2185 King W, Sherbrooke, Quebec, Canada. Electronic address: pierre.gervais@qtresearch.com.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Gorfinkel', 'Affiliation': 'PrimeHealth Clinical Research, 1849 Yonge Street, Suite 516, Toronto, Ontario, Canada. Electronic address: i.gor@outlook.com.'}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Hyung Kim', 'Affiliation': 'GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA. Electronic address: joon-hyung.k.kim@gsk.com.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Talarico', 'Affiliation': 'GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA. Electronic address: carla.a.talarico@gsk.com.'}, {'ForeName': 'Valentine', 'Initials': 'V', 'LastName': 'Wascotte', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: valentine.v.wascotte@gsk.com.'}, {'ForeName': 'Toufik', 'Initials': 'T', 'LastName': 'Zahaf', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: toufik.zahaf@gsk.com.'}, {'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Colindres', 'Affiliation': 'GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA. Electronic address: romcolindres@hotmail.com.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schuind', 'Affiliation': 'GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA. Electronic address: anne.a.schuind@gsk.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2019.09.028']
1378,30891748,Effects of Multicomponent Exercise on Frailty in Long-Term Nursing Homes: A Randomized Controlled Trial.,"OBJECTIVES


To determine the effect of multicomponent exercise on frailty and related adverse outcomes in residents of long-term nursing homes (LTNHs).
DESIGN


A single-blind randomized controlled trial.
SETTING


Ten LTNHs in Gipuzkoa, Spain.
PARTICIPANTS


The study sample comprised 112 men and women aged 70 years or older who scored 50 or higher on the Barthel Index, 20 or higher on the MEC-35 test (an adapted and validated version of the Mini-Mental State Examination in Spanish), and who were capable of standing up and walking independently for at least 10 m.
INTERVENTION


Subjects in the control group (CG) participated in routine activities. The intervention group (IG) participated in a 6-month program of individualized and progressive multicomponent exercise at moderate intensity.
MEASUREMENTS


Frailty was assessed by four different scales at baseline and at 6 months. The Barthel Index was measured at baseline and at 12 months. Frailty-related adverse outcomes were recorded from 12 months before to 12 months after starting the intervention.
RESULTS


A lower prevalence of frailty was observed in the IG compared with the CG according to Fried's frailty phenotype, Short Physical Performance Battery, and Tilburg Frailty Indicator after 6 months (p < .05). There was a decline in the CG on the Barthel Index after 12 months (p < .05), whereas score was maintained in the IG. Both groups experienced a similar number of falls before and after the intervention (p > .05), but during the 6-month intervention period, fewer falls were observed in the IG than the CG (p < .05). Lower overall mortality was observed 12 months after starting the intervention for the IG than the CG (1 vs 6, respectively; p = .05).
CONCLUSION


Individualized and progressive multicomponent exercise at moderate intensity seems to be effective to prevent falls and reduce frailty and mortality.",2019,"A lower prevalence of frailty was observed in the IG compared with the CG according to Fried's frailty phenotype, Short Physical Performance Battery, and Tilburg Frailty Indicator after 6 months (p < .05).","['Long-Term Nursing Homes', 'Ten LTNHs in Gipuzkoa, Spain', '112 men and women aged 70\u2009years or older who scored 50 or higher on the Barthel Index, 20 or higher on the MEC-35 test (an adapted and validated version of the Mini-Mental State Examination in Spanish), and who were capable of standing up and walking independently for at least 10 m', 'residents of long-term nursing homes (LTNHs']","['control group (CG) participated in routine activities', 'Multicomponent Exercise', 'individualized and progressive multicomponent exercise', 'multicomponent exercise', 'Individualized and progressive multicomponent exercise']","['Frailty-related adverse outcomes', 'Barthel Index', 'overall mortality', 'Frailty', 'prevalence of frailty']","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0444796', 'cui_str': 'Standing up (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",112.0,0.100678,"A lower prevalence of frailty was observed in the IG compared with the CG according to Fried's frailty phenotype, Short Physical Performance Battery, and Tilburg Frailty Indicator after 6 months (p < .05).","[{'ForeName': 'Haritz', 'Initials': 'H', 'LastName': 'Arrieta', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Rezola-Pardo', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.'}, {'ForeName': 'Susana M', 'Initials': 'SM', 'LastName': 'Gil', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.'}, {'ForeName': 'Janire', 'Initials': 'J', 'LastName': 'Virgala', 'Affiliation': 'Department of Nursing II, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Donostia, Spain.'}, {'ForeName': 'Miren', 'Initials': 'M', 'LastName': 'Iturburu', 'Affiliation': 'Matia Instituto, Donostia, Spain.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Antón', 'Affiliation': 'Matia Fundazioa, Donostia, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'González-Templado', 'Affiliation': 'Caser Betharram, Hondarribia, Spain.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Irazusta', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodriguez-Larrad', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, Spain.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15824']
1379,31197507,Obesity-related inflammatory modulation by juçara berry (Euterpe edulis Mart.) supplementation in Brazilian adults: a double-blind randomized controlled trial.,"PURPOSE


Obesity is an inflammatory-related disease, which recruits immune system cells triggering to imbalanced production of cytokines. Obesity management and treatment using foods bioactive compounds have gained clinical and scientific relevance. Juçara (Euterpe edulis Mart.) fruit is rich in fibers, unsaturated lipids and, anthocyanins showing potential health benefits. Thus, we investigated the effect of juçara pulp intake on inflammatory status of monocytes from obese individuals.
METHODS


It is a placebo-controlled, randomized double-blind trial. Twenty-seven obese participants (BMI between 30.0 and 39.9 kg/m 2 ) of both genders from 31 to 59-year-old, divided into two groups: 5 g juçara freeze-dried pulp or 5 g of placebo for 6 weeks. Before and after supplementation, blood samples were collected and monocytes obtained and stimulated with lipopolysaccharides. After 24 h of incubation, the cells and supernatants were analyzed.
RESULTS


Post-treatment, juçara reduced TLR4, and IL-6 mRNA compared to placebo. Juçara also increased IL-10 mRNA in post-treatment. The protein expression of TLR4 pathway post-treatment, MYD88 expression reduced in juçara group compared to placebo. The juçara post-treatment reduced pIKKα/β compared to the placebo. Ob-R protein levels were higher in the juçara group post-treatment compared to pre-treatment. IL-6, TNF-α, and MCP-1 production by monocytes were reduced by juçara in post-treatment compared to pre-treatment levels. The supplementation increased IL-10 in juçara group with LPS compared to pre-treatment and versus juçara group without LPS.
CONCLUSION


These results demonstrated a proinflammatory state at the beginning, which was improved by juçara pulp consumption. Our results suggest juçara pulp as a potential tool against the proinflammatory status of obesity.",2020,"pre-treatment. IL-6, TNF-α, and MCP-1 production by monocytes were reduced by juçara in post-treatment compared to pre-treatment levels.","['obese individuals', 'Brazilian adults', 'Twenty-seven obese participants (BMI between 30.0 and 39.9\xa0kg/m 2 ) of both genders from 31 to 59-year-old, divided into two groups']","['5\xa0g juçara freeze-dried pulp or 5\xa0g of placebo', 'juçara berry (Euterpe edulis Mart.) supplementation', 'placebo', 'LPS', 'juçara pulp intake']","['proinflammatory state', 'juçara reduced TLR4, and IL-6 mRNA', 'IL-10 mRNA', 'IL-6, TNF-α, and MCP-1 production by monocytes', 'protein expression of TLR4 pathway post-treatment, MYD88 expression', 'Ob-R protein levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005135', 'cui_str': 'Berries'}, {'cui': 'C1193660', 'cui_str': 'Euterpe edulis'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0033268'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}]",27.0,0.207803,"pre-treatment. IL-6, TNF-α, and MCP-1 production by monocytes were reduced by juçara in post-treatment compared to pre-treatment levels.","[{'ForeName': 'Aline Boveto', 'Initials': 'AB', 'LastName': 'Santamarina', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, 11015-020, Brazil.'}, {'ForeName': 'Giovana', 'Initials': 'G', 'LastName': 'Jamar', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, 11015-020, Brazil.'}, {'ForeName': 'Laís Vales', 'Initials': 'LV', 'LastName': 'Mennitti', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, 11015-020, Brazil.'}, {'ForeName': 'Helena de Cássia', 'Initials': 'HC', 'LastName': 'Cesar', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, 11015-020, Brazil.'}, {'ForeName': 'José Ronnie', 'Initials': 'JR', 'LastName': 'Vasconcelos', 'Affiliation': 'Departamento de Biociências, Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Rua Silva Jardim, 136, Térreo, Vila Mathias, Santos, São Paulo, 11015-020, Brazil.'}, {'ForeName': 'Lila Missae', 'Initials': 'LM', 'LastName': 'Oyama', 'Affiliation': 'Departamento de Fisiologia, Universidade Federal de São Paulo, São Paulo, 04023-062, Brazil.'}, {'ForeName': 'Veridiana Vera', 'Initials': 'VV', 'LastName': 'de Rosso', 'Affiliation': 'Departamento de Biociências, Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Rua Silva Jardim, 136, Térreo, Vila Mathias, Santos, São Paulo, 11015-020, Brazil.'}, {'ForeName': 'Luciana Pellegrini', 'Initials': 'LP', 'LastName': 'Pisani', 'Affiliation': 'Departamento de Biociências, Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Rua Silva Jardim, 136, Térreo, Vila Mathias, Santos, São Paulo, 11015-020, Brazil. lucianapisani@hotmail.com.'}]",European journal of nutrition,['10.1007/s00394-019-02024-2']
1380,30957635,Ambrisentan for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).,"This multicenter, randomized, double-blind, placebo-controlled study assessed ambrisentan or placebo in patients with inoperable chronic thromboembolic pulmonary hypertension. Futility of enrollment led to early termination. Trends of improvement in favor of ambrisentan versus placebo in the primary and some secondary endpoints were observed; adverse event profiles were similar between groups.",2019,Trends of improvement in favor of ambrisentan versus placebo in the primary and some secondary endpoints were observed; adverse event profiles were similar between groups.,"['patients with inoperable chronic thromboembolic pulmonary hypertension', 'inoperable chronic thromboembolic pulmonary hypertension (CTEPH']","['ambrisentan or placebo', 'Ambrisentan', 'placebo']",['adverse event profiles'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C2363973', 'cui_str': 'Thromboembolic pulmonary hypertension (disorder)'}]","[{'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.567955,Trends of improvement in favor of ambrisentan versus placebo in the primary and some secondary endpoints were observed; adverse event profiles were similar between groups.,"[{'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Escribano-Subias', 'Affiliation': '1 CIBERCV, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Hakim', 'Initials': 'H', 'LastName': 'Bendjenana', 'Affiliation': '2 GSK, Marly-le-roi Cedex, France.'}, {'ForeName': 'Paula S', 'Initials': 'PS', 'LastName': 'Curtis', 'Affiliation': '3 GSK, Stockley Park, Uxbridge, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Lang', 'Affiliation': '4 AKH-Vienna, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Vonk Noordegraaf', 'Affiliation': '5 Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}]",Pulmonary circulation,['10.1177/2045894019846433']
1381,31493548,Utility of a Three-Dimensional Printed Pelvic Model for Lateral Pelvic Lymph Node Dissection Education: A Randomized Controlled Trial.,"BACKGROUND


Lateral pelvic lymph node dissection for rectal cancer is a difficult technique due to the complex pelvic anatomy involved. Three-dimensional (3D) organ models have been introduced as education tools to study anatomy in some fields. In this study, we educated the participants about pelvic anatomy using a 3D model, and evaluated learning efficiency, comparing the outcomes with those using a traditional textbook.
STUDY DESIGN


This study was a randomized, controlled, single-center trial conducted between July 2018 and July 2019. A total of 102 participants (34 medical students, 34 residents, and 34 surgeons) were enrolled. Participants were randomly assigned to the 3D model group or the textbook group. First, they completed a short test to confirm their basic knowledge before further education. After collocated education, they completed the same short test again and another long test to evaluate their learning outcomes.
RESULTS


Before education, there was no significant difference in the short test scores between the 3D model group and the textbook group. After education, the short and long test scores of the 3D model group were significantly higher than those of the textbook group for students (short test; p = 0.05, long test; p = 0.03), residents (short test; p = 0.05, long test; p = 0.002), and surgeons (short test; p = 0.009, long test; p < 0.001).
CONCLUSIONS


Using a 3D pelvic model is superior to using a textbook when learning pelvic anatomy required for lateral pelvic lymph node dissection.",2019,"After education, the short and long test scores of the 3D model group were significantly higher than those of the textbook group for students (short test; p=0.05, long test; p=0.03), residents (short test; p=0.05, long test; p=0.002), and surgeons (short test; p=0.009, long test; p<0.001).
","['July 2018 and July 2019', 'Lateral Pelvic Lymph Node Dissection Education', '102 participants (34 medical students, 34 residents, and 34 surgeons) were enrolled']",[],['short test scores'],"[{'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]",[],"[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",102.0,0.0417582,"After education, the short and long test scores of the 3D model group were significantly higher than those of the textbook group for students (short test; p=0.05, long test; p=0.03), residents (short test; p=0.05, long test; p=0.002), and surgeons (short test; p=0.009, long test; p<0.001).
","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Hojo', 'Affiliation': 'Department of Surgical Oncology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan. Electronic address: HOJOD-SUR@h.u-tokyo.ac.jp.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Murono', 'Affiliation': 'Department of Surgical Oncology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Nozawa', 'Affiliation': 'Department of Surgical Oncology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Kawai', 'Affiliation': 'Department of Surgical Oncology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hata', 'Affiliation': 'Department of Surgical Oncology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Department of Surgical Oncology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Oba', 'Affiliation': 'Department of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Ishihara', 'Affiliation': 'Department of Surgical Oncology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2019.08.1443']
1382,31562911,Randomized Trial of Perioperative Probiotics Among Patients Undergoing Major Abdominal Operation.,"BACKGROUND


We investigated the utility and safety of short-course oral probiotics among patients undergoing major abdominal operations. Perioperative probiotics can decrease length of stay and lower rates of infectious complications. We assessed whether perioperative probiotics decrease major complications among patients undergoing high-risk gastrointestinal operations in a pragmatic randomized trial.
STUDY DESIGN


This double-blind trial randomized 135 patients undergoing elective major gastrointestinal operations to perioperative oral probiotic VSL#3 taken just before operation and twice daily up to 15 total doses (n = 67) or placebo (n = 68). The primary outcomes measure was 30-day composite end point of death, unplanned readmission, or any infection.
RESULTS


Primary end point occurred among 17 patients in the placebo group (25.0%) vs 22 patients in the probiotic group (32.8%; p = 0.315). Thirty-day mortality was 2 (2.9%) in the placebo group compared with 1 (1.5%) in the probiotic group (p = 1.000). The placebo group patients experienced lower 30-day readmission rate (3 of 68 [4.4%]) compared with the probiotic group (11 of 67 [16.4%]; p = 0.022). None of the placebo patients were readmitted for dehydration, but 5 of 11 probiotic group patients (45%; p = 0.049) were readmitted for dehydration as a consequence of diet intolerance and/or diarrhea. There was no difference in 30-day infection rate between the groups (15 or 68 [22%] in the placebo group vs 15 of 67 [22.4%] in the probiotic group; p = 0.963).
CONCLUSIONS


Perioperative use of VSL#3 probiotic did not affect 30-day composite end point of mortality, readmission, and infection rate. A significantly higher readmission rate was observed among those exposed to probiotics. Additional studies remain warranted.",2019,"There was no difference in 30-day infection rate between the groups (15/68, 22% in placebo versus 15/67, 22.4% in probiotic group, p=0.963).
","['high-risk gastrointestinal surgery patients', 'Patients Undergoing Major Abdominal Operation', 'patients undergoing major abdominal surgery', '135 patients undergoing elective major gastrointestinal surgery to perioperative oral probiotic VSL#3 taken just before operation and twice daily up to 15 total doses (n=67) or']","['Placebo', 'short-course oral probiotics', 'perioperative probiotics', 'placebo', 'Perioperative Probiotics']","['Thirty-day mortality', '30-day infection rate', 'readmission rate', 'readmitted for dehydration', 'diet intolerance and/or diarrhea', 'length of stay and lower rates of infectious complications', '30-day composite outcome of death, unplanned readmission, or any infection', '30-day composite outcome of mortality, readmission and infection rate', '30-day readmission rate']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal Surgical Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}]",135.0,0.307487,"There was no difference in 30-day infection rate between the groups (15/68, 22% in placebo versus 15/67, 22.4% in probiotic group, p=0.963).
","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Franko', 'Affiliation': 'Department of Surgery, Mercy Medical Center, Des Moines, IA. Electronic address: jan.franko@gmail.com.'}, {'ForeName': 'Shankar', 'Initials': 'S', 'LastName': 'Raman', 'Affiliation': 'Department of Surgery, Mercy Medical Center, Des Moines, IA.'}, {'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Krishnan', 'Affiliation': 'Department of Internal Medicine, Mercy Medical Center, Des Moines, IA.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Frankova', 'Affiliation': 'Department of Internal Medicine, Mercy Medical Center, Des Moines, IA.'}, {'ForeName': 'May C', 'Initials': 'MC', 'LastName': 'Tee', 'Affiliation': 'Department of Surgery, Mercy Medical Center, Des Moines, IA.'}, {'ForeName': 'Rushin', 'Initials': 'R', 'LastName': 'Brahmbhatt', 'Affiliation': 'Department of Surgery, Mercy Medical Center, Des Moines, IA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Goldman', 'Affiliation': 'Department of Surgery, Mercy Medical Center, Des Moines, IA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Weigel', 'Affiliation': 'Department of Surgery, University of Iowa, Iowa City, IA.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2019.09.002']
1383,31187261,The bioavailability of iron picolinate is comparable to iron sulfate when fortified into a complementary fruit yogurt: a stable iron isotope study in young women.,"PURPOSE


A technological gap exists for the iron (Fe) fortification of difficult-to-fortify products, such as wet and acid food products containing polyphenols, with stable and bioavailable Fe. Fe picolinate, a novel food ingredient, was found to be stable over time in this type of matrix. The objective of this study was to measure the Fe bioavailability of Fe picolinate in a complementary fruit yogurt.
METHODS


The bioavailability of Fe picolinate was determined using stable iron isotopes in a double blind, randomized cross-over design in non-anemic Swiss women (n = 19; 25.1 ± 4.6 years). Fractional Fe absorption was measured from Fe picolinate (2.5 mg  57 Fe per serving in two servings given morning and afternoon) and from Fe sulfate (2.5 mg  54 Fe per serving in two servings given morning and afternoon) in a fortified dairy complementary food (i.e. yogurt containing fruits). Fe absorption was determined based on erythrocyte incorporation of isotopic labels 14 days after consumption of the last test meal.
RESULTS


Geometric mean (95% CI) fractional iron absorption from Fe picolinate and Fe sulfate were not significantly different: 5.2% (3.8-7.2%) and 5.3% (3.8-7.3%) (N.S.), respectively. Relative bioavailability of Fe picolinate versus Fe sulfate was 0.99 (0.85-1.15).
CONCLUSION


Therefore, Fe picolinate is a promising compound for the fortification of difficult-to-fortify foods, to help meet Fe requirements of infants, young children and women of childbearing age.",2020,"Relative bioavailability of Fe picolinate versus Fe sulfate was 0.99 (0.85-1.15).
","['infants, young children and women of childbearing age', 'non-anemic Swiss women (n\u2009=\u200919; 25.1\u2009±\u20094.6\xa0years', 'young women']","['Fe picolinate versus Fe sulfate', 'iron picolinate', 'Fe sulfate (2.5\xa0mg', 'Fe picolinate']","['Geometric mean', 'fractional iron absorption from Fe picolinate and Fe sulfate', 'Relative bioavailability', 'bioavailability of Fe picolinate', 'Fe absorption', 'Fe bioavailability', 'Fractional Fe absorption']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0137028', 'cui_str': 'picolinate'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}, {'cui': 'C0967601', 'cui_str': 'iron(III) picolinate'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0137028', 'cui_str': 'picolinate'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",,0.063055,"Relative bioavailability of Fe picolinate versus Fe sulfate was 0.99 (0.85-1.15).
","[{'ForeName': 'Magalie', 'Initials': 'M', 'LastName': 'Sabatier', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Vers-chez-les-Blanc, 1000, Lausanne 26, Switzerland. magalie.sabatier@rdls.nestle.com.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Grathwohl', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Vers-chez-les-Blanc, 1000, Lausanne 26, Switzerland.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Beaumont', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Vers-chez-les-Blanc, 1000, Lausanne 26, Switzerland.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Groulx', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Vers-chez-les-Blanc, 1000, Lausanne 26, Switzerland.'}, {'ForeName': 'Laurence F', 'Initials': 'LF', 'LastName': 'Guignard', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Vers-chez-les-Blanc, 1000, Lausanne 26, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kastenmayer', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Vers-chez-les-Blanc, 1000, Lausanne 26, Switzerland.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Dubascoux', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Vers-chez-les-Blanc, 1000, Lausanne 26, Switzerland.'}, {'ForeName': 'Janique', 'Initials': 'J', 'LastName': 'Richoz', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Vers-chez-les-Blanc, 1000, Lausanne 26, Switzerland.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Habeych', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé SA, Vers-chez-les-Blanc, 1000, Lausanne 26, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Zeder', 'Affiliation': 'Laboratory of Human Nutrition, Institute of Food, Nutrition and Health, ETH Zurich, 8092, Zurich, Switzerland.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Moretti', 'Affiliation': 'Laboratory of Human Nutrition, Institute of Food, Nutrition and Health, ETH Zurich, 8092, Zurich, Switzerland.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Zimmermann', 'Affiliation': 'Laboratory of Human Nutrition, Institute of Food, Nutrition and Health, ETH Zurich, 8092, Zurich, Switzerland.'}]",European journal of nutrition,['10.1007/s00394-019-01989-4']
1384,30943553,Impact of a 1-day versus 3-day low-residue diet on bowel cleansing quality before colonoscopy: a randomized controlled trial.,"BACKGROUND


The aim of this study was to assess whether a 3-day low-residue diet (LRD) improved bowel cleansing quality compared with a 1-day LRD regimen.
METHODS


Consecutive patients scheduled for outpatient colonoscopy were randomized to the 1-day LRD or 3-day LRD groups. All patients received a 2-L split-dose of polyethylene glycol plus ascorbic acid. The primary outcome was bowel cleansing quality as evaluated using the Boston Bowel Preparation Scale (BBPS) (adequate cleansing ≥ 2 points per segment). Secondary outcomes were adherence to and level of satisfaction with the LRD, difficulty following the dietary recommendations, and willingness to repeat the same LRD in the future. Intention-to-treat (ITT) and per-protocol (PP) analyses were conducted for the primary outcome. A superiority analysis was performed to demonstrate that a 3-day LRD regimen was superior to a 1-day LRD regimen with a margin of 10 %.
RESULTS


390 patients (1-day LRD group = 196, 3-day LRD = 194) were included. The cleansing quality was not significantly different between the groups: ITT analysis 82.7 % (95 % confidence interval [CI] 77.4 to 88.0) vs. 85.6 % (95 %CI 80.7 to 90.5), with odds ratio (OR) 1.2 (95 %CI 0.72 to 2.15); PP analysis 85.0 % (95 %CI 79.9 to 90.1) vs. 88.6 % (95 %CI 84.0 to 93.2), with OR 1.4 (95 %CI 0.88 to 2.52). No differences were found regarding adherence to the diet or cleansing solution, satisfaction or difficulty with the LRD, and the polyp/adenoma detection rates.
CONCLUSION


3-day LRD did not offer advantages over 1-day LRD in preparation for colonoscopy.",2019,"The cleansing quality was not significantly different between the groups: ITT analysis 82.7 % (95 % confidence interval [CI] 77.4 to 88.0) vs. 85.6 % (95 %CI 80.7 to 90.5), with odds ratio (OR) 1.2 (95 %CI 0.72 to 2.15); PP analysis 85.0 % (95 %CI 79.9 to 90.1) vs. 88.6 % (95 %CI 84.0 to 93.2), with OR 1.4 (95 %CI 0.88 to 2.52).","['390 patients (1-day LRD group\u200a=\u200a196, 3-day LRD\u200a=\u200a194) were included', 'Consecutive patients scheduled for outpatient colonoscopy', 'before colonoscopy']","['1-day LRD or 3-day LRD', '1-day versus 3-day low-residue diet', 'Intention-to-treat (ITT) and per-protocol (PP', '3-day low-residue diet (LRD', '2-L split-dose of polyethylene glycol plus ascorbic acid']","['bowel cleansing quality', 'Boston Bowel Preparation Scale (BBPS) (adequate cleansing\u200a≥\u200a2 points per segment', 'cleansing quality', 'adherence to and level of satisfaction with the LRD, difficulty following the dietary recommendations, and willingness to repeat the same LRD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0425404', 'cui_str': 'Low residue diet (finding)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]",390.0,0.202098,"The cleansing quality was not significantly different between the groups: ITT analysis 82.7 % (95 % confidence interval [CI] 77.4 to 88.0) vs. 85.6 % (95 %CI 80.7 to 90.5), with odds ratio (OR) 1.2 (95 %CI 0.72 to 2.15); PP analysis 85.0 % (95 %CI 79.9 to 90.1) vs. 88.6 % (95 %CI 84.0 to 93.2), with OR 1.4 (95 %CI 0.88 to 2.52).","[{'ForeName': 'Antonio Z', 'Initials': 'AZ', 'LastName': 'Gimeno-García', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'de la Barreda Heuser', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Reygosa', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Hernandez', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mascareño', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios. Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nicolás-Pérez', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Jiménez', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Lara', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Onofre', 'Initials': 'O', 'LastName': 'Alarcon-Fernández', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Hernandez-Guerra', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romero', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Alonso', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Yanira', 'Initials': 'Y', 'LastName': 'González', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Zaida', 'Initials': 'Z', 'LastName': 'Adrian', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Goretti', 'Initials': 'G', 'LastName': 'Hernandez', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Hernandez', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Delgado', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Quintero', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.'}]",Endoscopy,['10.1055/a-0864-1942']
1385,31409579,Improved high-quality colon cleansing with 1L NER1006 versus 2L polyethylene glycol + ascorbate or oral sulfate solution.,"BACKGROUND & AIMS


Colonoscopy requires bowel cleansing for gut mucosa visualization; high-quality cleansing facilitates lesion detection. NER1006 is a 1L polyethylene glycol (PEG) bowel preparation. This post hoc analysis of two randomized trials investigated cleansing efficacy assessed, as in clinical practice, by site endoscopists.
METHODS


Patients received NER1006, 2L PEG + ascorbate (2LPEG), or oral sulfate solution (OSS) as a 2-day evening/morning regimen (N2D) or NER1006 morning-only dosing (N1D). Treatment-blinded site endoscopists assessed cleansing using the Harefield Cleansing Scale (HCS). Analyses were conducted in a modified full analysis set, including (mFAS; n = 1378) or excluding (mFAS2; n = 1319) imputed failures, and in patients with 100% treatment adherence (mFAS100; n = 1047). Overall cleansing success (HCS grade A/B), overall high-quality cleansing (HCS grade A), and high-quality segments (HCS 3-4) per treatment population were analyzed.
RESULTS


Overall cleansing success was higher with N2D than 2LPEG (92.7-97.5% vs. 87.9-93.0%), and more patients had overall high-quality cleansing with N2D and N1D than 2LPEG (68.0-72.1% and 64.0-68.4% vs. 50.7-56.0%). Without imputed failures, N2D delivered more overall high-quality cleansing than OSS (74.5-77.3% vs. 67.8-69.8%). More high-quality segments were demonstrated with N2D and N1D versus 2 LPEG (82.5-87.1% and 79.4-84.4% vs. 70.4-76.3%) and with N2D versus OSS (82.7-89.5% vs. 78.1-84.4%).
CONCLUSION


When assessed by site endoscopists, NER1006 delivers greater high-quality cleansing than 2LPEG or OSS.",2019,"When assessed by site endoscopists, NER1006 delivers greater high-quality cleansing than 2LPEG or OSS.",[],"['2LPEG', 'NER1006 morning-only dosing (N1D', 'NER1006, 2L PEG\u202f+\u202fascorbate (2LPEG), or oral sulfate solution (OSS', 'Treatment-blinded site endoscopists assessed cleansing using the Harefield Cleansing Scale (HCS', '1L NER1006 versus 2L polyethylene glycol\u202f+\u202fascorbate or oral sulfate solution', 'NER1006']","['overall high-quality cleansing', 'Overall cleansing success', 'Overall cleansing success (HCS grade A/B), overall high-quality cleansing (HCS grade A), and high-quality segments']",[],"[{'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0857241', 'cui_str': 'Ascorbate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0449206', 'cui_str': 'OSS (body structure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0309195', 'cui_str': 'Grade A (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}]",1378.0,0.117759,"When assessed by site endoscopists, NER1006 delivers greater high-quality cleansing than 2LPEG or OSS.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Repici', 'Affiliation': 'Humanitas University, Milan, Italy.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Coron', 'Affiliation': 'Centre Hospitalier Universitaire Hotel Dieu, Nantes, France.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Gastroenterology and Hepatology, Veterans Affairs Medical Center, Kansas City, MO, USA; Department of Gastroenterology and Hepatology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Spada', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli, Rome, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Di Leo', 'Affiliation': 'Humanitas University, Milan, Italy.'}, {'ForeName': 'Colin L', 'Initials': 'CL', 'LastName': 'Noble', 'Affiliation': 'Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gschossmann', 'Affiliation': 'Klinikum Forchheim, Forchheim, Germany.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Bargalló García', 'Affiliation': 'Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí, Spain; Endos Medicina, Barcelona, Spain.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Baumgart', 'Affiliation': 'Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada. Electronic address: baumgart@ualberta.ca.'}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2019.06.026']
1386,31189519,"Durability of insulin degludec plus liraglutide versus insulin glargine U100 as initial injectable therapy in type 2 diabetes (DUAL VIII): a multicentre, open-label, phase 3b, randomised controlled trial.","BACKGROUND


Durability of glycaemic control might reduce disease burden and improve long-term outcomes. DUAL VIII investigated the durability of insulin degludec plus liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) in patients with type 2 diabetes with the use of a visit schedule that mirrored routine clinical practice.
METHODS


In this 104-week international, multicentre, open-label, phase 3b randomised controlled trial, insulin-naive patients aged 18 years and older, with HbA 1c  between 7·0-11·0% (53-97 mmol/mol), BMI of 20 kg/m 2  or higher, on stable doses of oral antidiabetic drugs, were recruited from outpatient clinics. Patients were randomly assigned 1:1, with a simple sequential allocation randomisation schedule (block size of four), to IDegLira or IGlar U100, each treatment being an add-on to existing therapy. The internal safety committee, the independent external committee, and the personnel involved in defining the analysis sets were masked until the database was released for statistical analysis. Patients and all other investigators were not masked. In the IDegLira group, patients were given degludec 100 units/mL plus liraglutide 3·6 mg/mL in a 3 mL prefilled PDS290 pen for subcutaneous injection; in the IGlar U100 group, patients were given IGlar U100 solution, in a 3 mL prefilled Solostar pen for subcutaneous injection. Both treatments were given once daily at any time of day and it was recommended that the time of day remained the same throughout the trial. The primary endpoint was time from randomisation to need for treatment intensification (HbA 1c  ≥7·0% [53 mmol/mol] at two consecutive visits, including week 26). Once patients met this criterion, the trial product was permanently discontinued and patients were not withdrawn from trial but rather remained on follow-up for the entire treatment and follow-up period. The primary analysis was in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT02501161.
FINDINGS


From Jan 8, 2016, to Oct 3, 2018, 1345 patients were screened, of which 1012 (75·2%) were eligible and randomly assigned to either IDegLira (n=506) or IGlar U100 (n=506). 484 (96%) of 506 in the IDegLira group and 481 (95%) of 506 in the IGlar U100 group completed the trial. Baseline characteristics were similar and representative of patients eligible for basal insulin intensification (overall mean diabetes duration 10 years; HbA 1c  8·5% [69 mmol/mol]; fasting plasma glucose 10 mmol/L). Patients in the IDegLira group had significantly longer time until intensification was needed than those in the IGlar U100 group (median >2 years vs about 1 year). Fewer patients in the IDegLira group needed treatment intensification over 104 weeks than those in the IGlar U100 group (189 [37%] of 506 vs 335 [66%] of 506). The preplanned sensitivity analyses of the primary endpoint were in agreement with the primary analysis (hazard ratio 0·45 [95% CI 0·38-0·54]) in the proportional hazards regression model and the generalised log-rank test was also in favour of IDegLira (p<0·0001). No new or unexpected safety and tolerability issues were identified and there were no treatment-related deaths.
INTERPRETATION


In patients with uncontrolled type 2 diabetes on oral antidiabetic drugs, initial injectable therapy with IDegLira resulted in fewer patients reaching the treatment intensification criterion during 104 weeks versus IGlar U100, with longer durability of the treatment effect with IDegLira.
FUNDING


Novo Nordisk.",2019,Fewer patients in the IDegLira group needed treatment intensification over 104 weeks than those in the IGlar U100 group (189 [37%] of 506 vs 335 [66%] of 506).,"['patients with type 2 diabetes with the use of a visit schedule that mirrored routine clinical practice', 'patients with uncontrolled type 2 diabetes on oral antidiabetic drugs', 'From Jan 8, 2016, to Oct 3, 2018, 1345 patients were screened, of which 1012 (75·2%) were eligible and randomly assigned to either IDegLira (n=506) or IGlar U100 (n=506', 'type 2 diabetes (DUAL VIII', 'naive patients aged 18 years and older, with HbA 1c  between 7·0-11·0% (53-97 mmol/mol), BMI of 20 kg/m 2  or higher, on stable doses of oral antidiabetic drugs, were recruited from outpatient clinics', '484 (96%) of 506 in the IDegLira group and 481 (95%) of 506 in the IGlar U100 group completed the trial']","['liraglutide 3·6 mg/mL in a 3 mL prefilled PDS290 pen', 'simple sequential allocation randomisation schedule (block size of four), to IDegLira or IGlar U100, each treatment being an add-on to existing therapy', 'insulin', 'insulin degludec plus liraglutide versus insulin glargine U100', 'insulin degludec plus liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100']","['time from randomisation to need for treatment intensification', 'longer time until intensification']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0445599', 'cui_str': 'VIII'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C4319659', 'cui_str': 'Pen (unit of presentation)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",1345.0,0.149931,Fewer patients in the IDegLira group needed treatment intensification over 104 weeks than those in the IGlar U100 group (189 [37%] of 506 vs 335 [66%] of 506).,"[{'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA; MedStar Health Research Institute, Hyattsville, MD, USA. Electronic address: varoda@bwh.harvard.edu.""}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'González-Galvez', 'Affiliation': 'Jalisco Institute of Research in Diabetes and Obesity SC, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Grøn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Halladin', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haluzík', 'Affiliation': 'Institute for Clinical and Experimental Medicine and Institute of Endocrinology, Prague, Czech Republic.'}, {'ForeName': 'György', 'Initials': 'G', 'LastName': 'Jermendy', 'Affiliation': 'Bajcsy-Zsilinszky Hospital, Budapest, Hungary.'}, {'ForeName': 'Adri', 'Initials': 'A', 'LastName': 'Kok', 'Affiliation': 'Union and Clinton Hospitals in Alberton, Gauteng, South Africa.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Őrsy', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sabbah', 'Affiliation': 'Hadassah University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Sesti', 'Affiliation': 'Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silver', 'Affiliation': 'Southern New Hampshire Diabetes and Endocrinology, Nashua, NH, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30184-6']
1387,31189520,"Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial.","BACKGROUND


Oral semaglutide is the first oral formulation of a glucagon-like peptide-1 (GLP-1) receptor agonist developed for the treatment of type 2 diabetes. We aimed to compare the efficacy and safety of flexible dose adjustments of oral semaglutide with sitagliptin 100 mg.
METHODS


In this 52-week, multicentre, randomised, open-label, phase 3a trial, we recruited patients with type 2 diabetes from 81 sites in ten countries. Patients were eligible if they were aged 18 years or older (19 years or older in South Korea), had type 2 diabetes (diagnosed ≥90 days before screening), HbA 1c  of 7·5-9·5% (58-80 mmol/mol), and were inadequately controlled on stable daily doses of one or two oral glucose-lowering drugs (for 90 days or more before screening). Participants were randomly assigned (1:1) by use of an interactive web-response system, stratified by background glucose-lowering medication at screening, to oral semaglutide with flexible dose adjustments to 3, 7, or 14 mg once daily or sitagliptin 100 mg once daily. To approximate treatment individualisation in clinical practice, oral semaglutide dose could be adjusted on the basis of prespecified HbA 1c  and tolerability criteria. Two efficacy-related estimands were prespecified: treatment policy (regardless of treatment discontinuation or use of rescue medication) and trial product (on treatment and without use of rescue medication) for participants randomly assigned to treatment. The primary endpoint was achievement of HbA 1c  of less than 7% (53 mmol/mol) at week 52 and the confirmatory secondary efficacy endpoint was change in bodyweight from baseline to week 52. Safety was assessed in all participants who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02849080, and European Clinical Trials Database, EudraCT number 2015-005593-38, and an open-label extension is ongoing.
FINDINGS


Between Sept 20, 2016, and Feb 7, 2017, of 804 patients assessed for eligibility, 504 were eligible and randomly assigned to oral semaglutide (n=253) or sitagliptin (n=251). Most participants were male (285 [57%] of 504) with a mean age of 57·4 years (SD 9·9). All participants were given at least one dose of their allocated study drug except for one participant in the sitagliptin group. From a mean baseline HbA 1c  of 8·3% (SD 0·6%; 67 mmol/mol [SD 6·4]), a greater proportion of participants achieved an HbA 1c  of less than 7% with oral semaglutide than did with sitagliptin (treatment policy estimand: 58% [134 of 230] vs 25% [60 of 238]; and trial product estimand: 63% [123 of 196] vs 28% [52 of 184]). The odds of achieving an HbA 1c  of less than 7% was significantly better with oral semaglutide than sitagliptin (treatment policy estimand: odds ratio [OR] 4·40, 95% CI 2·89-6·70, p<0·0001; and trial product estimand: 5·54, 3·54-8·68, p<0·0001). The odds of decreasing mean bodyweight from baseline to week 52 were higher with oral semaglutide than with sitagliptin (estimated mean change in bodyweight, treatment policy estimand: -2·6 kg [SE 0·3] vs -0·7 kg [SE 0·2], estimated treatment difference [ETD] -1·9 kg, 95% CI -2·6 to -1·2; p<0·0001; and trial product estimand: -2·9 kg [SE 0·3] vs -0·8 kg [SE 0·3], ETD -2·2 kg, -2·9 to -1·5; p<0·0001). Adverse events occurred in 197 (78%) of 253 participants in the oral semaglutide group versus 172 (69%) of 250 in the sitagliptin group, and nausea was the most common adverse event with oral semaglutide (53 [21%]). Two deaths occurred in the sitagliptin group during the trial.
INTERPRETATION


Oral semaglutide, with flexible dose adjustment, based on efficacy and tolerability, provided superior glycaemic control and weight loss compared with sitagliptin, and with a safety profile consistent with subcutaneous GLP-1 receptor agonists.
FUNDING


Novo Nordisk A/S.",2019,"The odds of decreasing mean bodyweight from baseline to week 52 were higher with oral semaglutide than with sitagliptin (estimated mean change in bodyweight, treatment policy estimand: -2·6 kg [SE 0·3] vs -0·7 kg [SE 0·2], estimated treatment difference [ETD]","['type 2 diabetes (PIONEER 7', 'Between Sept 20, 2016, and Feb 7, 2017, of 804 patients assessed for eligibility, 504 were eligible and randomly assigned to oral semaglutide (n=253) or sitagliptin (n=251', 'patients with type 2 diabetes from 81 sites in ten countries', 'participants who received at least one dose of study drug', 'Most participants were male (285 [57%] of 504) with a mean age of 57·4 years (SD 9·9', 'Patients were eligible if they were aged 18 years or older (19 years or older in South Korea), had type 2 diabetes (diagnosed ≥90 days before screening), HbA 1c  of 7·5-9·5% (58-80 mmol/mol), and were inadequately controlled on stable daily doses of one or two oral glucose-lowering drugs (for 90 days or more before screening']","['interactive web-response system, stratified by background glucose-lowering medication at screening, to oral semaglutide with flexible dose adjustments to 3, 7, or 14 mg once daily or sitagliptin 100 mg once daily', 'estimand: -2·9 kg [SE 0·3', 'oral semaglutide with sitagliptin 100 mg', 'oral semaglutide with flexible dose adjustment versus sitagliptin', 'sitagliptin']","['mean bodyweight', 'treatment difference [ETD', 'Adverse events', 'achievement of HbA 1c  of less', 'efficacy and tolerability', 'Efficacy and safety', 'efficacy and safety', 'nausea', 'Safety']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.19469,"The odds of decreasing mean bodyweight from baseline to week 52 were higher with oral semaglutide than with sitagliptin (estimated mean change in bodyweight, treatment policy estimand: -2·6 kg [SE 0·3] vs -0·7 kg [SE 0·2], estimated treatment difference [ETD]","[{'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria. Electronic address: thomas.pieber@medunigraz.at.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Atlanta, GA, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Mertens', 'Affiliation': 'Clinical and Experimental Endocrinology, Department of Chronic Diseases, Metabolism and Aging (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Young Min', 'Initials': 'YM', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Christiansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Christin L', 'Initials': 'CL', 'LastName': 'Hertz', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Signe O R', 'Initials': 'SOR', 'LastName': 'Wallenstein', 'Affiliation': 'Novo Nordisk A/S, Aalborg, Denmark.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30194-9']
1388,31128875,"Effect on meningococcal serogroup W immunogenicity when Tdap was administered prior, concurrent or subsequent to the quadrivalent (ACWY) meningococcal CRM 197 -conjugate vaccine in adult Hajj pilgrims: A randomised controlled trial.","Immune responses to the capsular polysaccharide administered in the polysaccharide-protein conjugate vaccines can be either improved or suppressed by the pre-existence of immunity to the carrier protein. Receiving multiple vaccinations is essential for travellers such as Hajj pilgrims, and the use of conjugated vaccines is recommended. We studied the immune response to meningococcal serogroup W upon prior, concurrent and sequential administration of a quadrivalent meningococcal conjugate vaccine (MCV4) conjugated to CRM 197  (coadministered with 13 valent pneumococcal vaccine conjugate CRM 197  [PCV13]), and tetanus-diphtheria-acellular pertussis (Tdap) vaccine in Australian adults before attending the Hajj pilgrimage in 2014. Participants were randomly assigned, by computer-generated numbers, to three study arms by 1:1:1 ratio. Group A received Tdap followed by MCV4-CRM 197  (+PCV13) 3-4 weeks later. Group B received all three vaccines in a single visit. Group C received MCV4-CRM 197  (+PCV13) followed by Tdap 3-4 weeks later. Blood samples obtained prior to and 3-4 weeks after immunisation with MCV4-CRM 197  were tested for meningococcal serogroup W-specific serum bactericidal antibody responses using baby rabbit complement (rSBA). One hundred and seven participants aged between 18 and 64 (median 40) years completed the study. No significant difference in meningococcal serogroup W rSBA geometric mean titre (GMT) was observed between the study arms post vaccination with MCV-CRM 197  but Group A tended to have a slightly lower GMT (A = 404, B = 984 and C = 1235, p = 0.15). No statistical difference was noticed between the groups in proportions of subjects achieving a ≥4-fold rise in rSBA titres or achieving rSBA titre ≥8 post vaccination. In conclusion, receipt of MCV4-CRM 197  vaccine prior, concurrent or subsequent to Tdap has similar immunologic response, and hence concurrent administration is both immunogenic and practical. However, further investigation into whether carrier induced suppression is a public health issue is suggested. Clinical trial registration: ANZCTR no. ACTRN12613000536763.",2019,No statistical difference was noticed between the groups in proportions of subjects achieving a ≥4-fold rise in rSBA titres or achieving rSBA titre ≥8,"['Australian adults before attending the Hajj pilgrimage in 2014', 'adult Hajj pilgrims', 'One hundred and seven participants aged between 18 and 64 (median 40) years completed the study']","['Tdap', 'MCV4-CRM 197  (+PCV13', 'quadrivalent meningococcal conjugate vaccine (MCV4) conjugated to CRM 197  (coadministered with 13 valent pneumococcal vaccine conjugate CRM 197  [PCV13]), and tetanus-diphtheria-acellular pertussis (Tdap) vaccine', 'Tdap followed by MCV4-CRM 197  (+PCV13']","['rSBA titres or achieving rSBA titre ≥8', 'meningococcal serogroup W rSBA geometric mean titre (GMT']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0056499', 'cui_str': 'cross reacting material (CRM(197)) of diphtheria toxin'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C2714181', 'cui_str': '13-valent pneumococcal vaccine'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",107.0,0.0525044,No statistical difference was noticed between the groups in proportions of subjects achieving a ≥4-fold rise in rSBA titres or achieving rSBA titre ≥8,"[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Tashani', 'Affiliation': ""The Discipline of Child and Adolescent Health, Children's Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; Faculty of Medicine, University of Tripoli, Ain Zara, Tripoli, Libya.""}, {'ForeName': 'Al-Mamoon', 'Initials': 'AM', 'LastName': 'Badahdah', 'Affiliation': ""The Discipline of Child and Adolescent Health, Children's Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia; Department of Family and Community Medicine, Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah, Saudi Arabia. Electronic address: almamoon.badahdah@health.nsw.gov.au.""}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alfelali', 'Affiliation': ""The Discipline of Child and Adolescent Health, Children's Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia; Department of Family and Community Medicine, Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah, Saudi Arabia.""}, {'ForeName': 'Osamah', 'Initials': 'O', 'LastName': 'Barasheed', 'Affiliation': 'The Executive Administration of Research and Innovation, King Abdullah Medical City in Holy Capital (KAMC-HC), Makkah 24246, Saudi Arabia.'}, {'ForeName': 'Amani S', 'Initials': 'AS', 'LastName': 'Alqahtani', 'Affiliation': 'Saudi Food and Drug Authority, Riyadh 13312, Saudi Arabia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Heron', 'Affiliation': ""National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': ""Immunology Department, The Children's Hospital at Westmead, Westmead 2145, NSW, Australia.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Louth', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Harunor', 'Initials': 'H', 'LastName': 'Rashid', 'Affiliation': ""The Discipline of Child and Adolescent Health, Children's Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia; Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Biological Sciences and Sydney Medical School, University of Sydney, Sydney, NSW 2145, Australia.""}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Borrow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Booy', 'Affiliation': ""The Discipline of Child and Adolescent Health, Children's Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, NSW, Australia; National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW, Australia; Marie Bashir Institute for Infectious Diseases and Biosecurity, School of Biological Sciences and Sydney Medical School, University of Sydney, Sydney, NSW 2145, Australia; WHO Collaborating Centre for Mass Gatherings and High Consequence/High Visibility Events, Flinders University, Adelaide 5001, Australia.""}]",Vaccine,['10.1016/j.vaccine.2019.05.025']
1389,31146138,Intranasal oxytocin alters amygdala-temporal resting-state functional connectivity in body dysmorphic disorder: A double-blind placebo-controlled randomized trial.,"The aetiology of body dysmorphic disorder (BDD) is poorly understood. Recent evidence from functional brain imaging studies suggests that BDD is associated with aberrant task-based functional connectivity and that intranasal oxytocin (OXT) may improve network connectivity in BDD patients. Thus, the aim of this study was to investigate the effect of intranasal OXT on amygdala resting-state functional connectivity (rsFC) in BDD. In a randomized, double-blind, cross-over design, 19 BDD participants and 17 demographically matched healthy control participants received intranasal OXT (24 IU) or placebo prior to resting-state functional magnetic resonance imaging. The left and right amygdala were seeded as regions of interest, and temporal correlations between the amygdalae and all other voxels comprising cortical and subcortical grey matter were investigated. Compared to healthy controls, BDD patients showed greater baseline (placebo) rsFC between the left amygdala and two clusters within the left temporal lobe and one cluster within the superior frontal gyrus which was reversed following OXT administration. The control group also showed significantly greater rsFC between the left amygdala and anterior prefrontal cortex in the OXT session compared to placebo. Whilst preliminary, these findings suggest that BDD patients exhibit abnormal amygdala-temporal connectivity at rest, and OXT might have a role in changing this functional relationship.",2019,The control group also showed significantly greater rsFC between the left amygdala and anterior prefrontal cortex in the OXT session compared to placebo.,"['BDD patients', '19 BDD participants and 17 demographically matched healthy control participants', 'body dysmorphic disorder']","['intranasal OXT', 'Intranasal oxytocin', 'intranasal oxytocin (OXT', 'placebo']","['rsFC between the left amygdala and anterior prefrontal cortex', 'amygdala resting-state functional connectivity (rsFC', 'network connectivity']","[{'cui': 'C0049759', 'cui_str': 'diphenyl dimethyl dicarboxylate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005887', 'cui_str': 'Body Image Disorders'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",19.0,0.333803,The control group also showed significantly greater rsFC between the left amygdala and anterior prefrontal cortex in the OXT session compared to placebo.,"[{'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Grace', 'Affiliation': 'Centre for Mental Health, Swinburne University, Melbourne, Australia; School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia. Electronic address: sgrace@swin.edu.au.'}, {'ForeName': 'Izelle', 'Initials': 'I', 'LastName': 'Labuschagne', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Castle', 'Affiliation': ""Psychiatry, St Vincent's Hospital, Melbourne, Australia; Psychiatry, University of Melbourne, Melbourne, Australia.""}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Rossell', 'Affiliation': ""Centre for Mental Health, Swinburne University, Melbourne, Australia; Psychiatry, St Vincent's Hospital, Melbourne, Australia.""}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.05.022']
1390,31781701,Sinus augmentation grafting with anorganic bovine bone versus 50% autologous bone mixed with 50% anorganic bovine bone: 5 years after loading results from a randomised controlled trial.,"PURPOSE


To compare the outcomes of implants inserted in maxillary sinuses augmented with 100% anorganic bovine bone (ABB) grafts versus mixed with 50% ABB and 50% autologous bone graft using a lateral window approach.
MATERIALS AND METHODS


This study was designed as a randomised controlled trial of parallel groups. Patients in need of an implant-supported prosthesis in maxillary posterior areas, with a residual alveolar bone height ranging between 0 and 4 mm, were recruited for lateral sinus grafting and implant placement. Patients were randomly allocated to receive two different graft materials according to a parallel group design: group A was grafted with 50% ABB and 50% autogenous bone; group B was grafted with 100% ABB. After 7 months, tapered implants were inserted with an insertion torque between 20 and 45 Ncm. Three months later implants were loaded with screw-retained temporary crowns. Definitive crowns were delivered after 3 months. Outcome measures were implant and prosthesis survival rates, complications, radiographic marginal bone-level changes, probing pocket depths (PPDs) and bleeding on probing (BOP). Clinical data were collected at definitive prosthesis delivery, and 1, 2 and 5 years after definitive loading.
RESULTS


Thirty-two consecutive patients were treated with 32 sinus elevation procedures (16 group A, 16 group B). A total of 46 implants were inserted. One patient (with two implants) dropped out in group A, and two patients (with three implants) dropped out in group B. No implant/crown failed by the end of the study. Three complications (one sinus membrane perforation and two chipping of the ceramic) were observed in three patients in group A, versus none in group B (relative risk was 0.81; 95% CI 0.64-1.03; P = 0.225). At the 2-year follow-up, the mean marginal bone loss was 1.18 ± 0.50 mm (95% CI 0.95-1.45 mm) in group A and 1.28 ± 0.48 mm (95% CI 0.97-1.43 mm) in group B, with no statistically significant differences between the two groups (difference 0.11 ± 0.22 mm; 95% CI -0.06-0.16 mm; P = 0.586). At the 5-year follow-up, the mean marginal bone loss was 1.37 ± 0.48 mm (95% CI 1.13-1.86 mm) in group A and 1.42 ± 0.48 mm (95% CI 1.17-1.90 mm) in group B (difference 0.15 ± 0.08 mm; 95% CI 0.10-0.22 mm; P = 0.426). At the 2-year follow-up, the mean PPD value was 2.70 ± 0.39 mm for group A and 2.54 ± 0.66 mm for group B, with no statistically significant difference between groups (difference 0.17 ± 0.39 mm; 95% CI 0.06-0.32 mm; P = 0.456). At the 5-year follow-up, the mean PPD value was 3.20 ± 0.44 mm for group A and 3.32 ± 0.49 mm for group B (difference 0.12 ± 0.43 mm; 95% CI 0.02-0.22 mm; P = 0.672). At the 2-year follow-up, the mean BOP value was 1.21 ± 0.79 for group A and 1.28 ± 0.68 for group B (difference 0.06 ± 0.49; 95% CI -0.23-0.25; P = 0.297), and at the 5-year follow-up, the mean BOP value was 1.77 ± 0.62 for group A and 1.91 ± 0.48 for group B (difference: 0.14 ± 0.51; 95% CI -0.05-0.33; P = 0.492).
CONCLUSIONS


Within the limitations of this study, the present data confirm similar clinical outcomes of implants inserted in sinuses grafted with ABB versus implants inserted in sinuses grafted with mixed 50% ABB and 50% autologous bone.",2019,"Three complications (one sinus membrane perforation and two chipping of the ceramic) were observed in three patients in group A, versus none in group B (relative risk was 0.81; 95% CI 0.64-1.03; P = 0.225).","['Patients in need of an implant-supported prosthesis in maxillary posterior areas, with a residual alveolar bone height ranging between 0 and 4 mm, were recruited for lateral sinus grafting and implant placement']","['Sinus augmentation grafting with anorganic bovine bone versus 50% autologous bone mixed with 50% anorganic bovine bone', 'anorganic bovine bone (ABB) grafts versus mixed with 50% ABB and 50% autologous bone graft', '32 sinus elevation procedures']","['mean PPD value', 'mean marginal bone loss', 'implant and prosthesis survival rates, complications, radiographic marginal bone-level changes, probing pocket depths (PPDs) and bleeding on probing (BOP', 'mean BOP value']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0226864', 'cui_str': 'Sinus Transversus'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C2236586', 'cui_str': 'Sinus graft'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C1699650', 'cui_str': 'Autologous bone graft'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0524929', 'cui_str': 'Prosthetic Implants'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",32.0,0.215395,"Three complications (one sinus membrane perforation and two chipping of the ceramic) were observed in three patients in group A, versus none in group B (relative risk was 0.81; 95% CI 0.64-1.03; P = 0.225).","[{'ForeName': 'Silvio Mario', 'Initials': 'SM', 'LastName': 'Meloni', 'Affiliation': ''}, {'ForeName': 'Aurea', 'Initials': 'A', 'LastName': 'Lumbau', 'Affiliation': ''}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Spano', 'Affiliation': ''}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Baldoni', 'Affiliation': ''}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Pisano', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Tullio', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tallarico', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1391,31174239,Increased local failure for patients with intermediate-risk rhabdomyosarcoma on ARST0531: A report from the Children's Oncology Group.,"BACKGROUND


The objective of this study was to evaluate local control for patients with intermediate-risk rhabdomyosarcoma (RMS) treated on Children's Oncology Group (COG) protocol ARST0531.
METHODS


This study analyzed 424 patients with intermediate-risk RMS. Patients were randomized to chemotherapy with either vincristine, dactinomycin, and cyclophosphamide (VAC) or VAC alternating with vincristine and irinotecan. With the goal of improving local control, radiation therapy (RT) was delivered early at week 4 and was concurrent with irinotecan in the experimental arm. Individualized local control plans for children 24 months old or younger were allowed. Local failure on ARST0531 was compared with local failure on the preceding COG intermediate-risk study, D9803.
RESULTS


For patients with group I/II alveolar RMS (n = 55), the 5-year cumulative incidence of local failure was 13.4%; for group III alveolar RMS (n = 141), it was 20.2%; and for group III embryonal RMS (n = 228), it was 27.9% (P = .03). Among patients with group III disease, local failure did not differ by histology, site, nodal status, RT modality, or treatment arm. Local failure was worse for a tumor size >5 cm (32.3% vs 16.7%; P = .001). Among patients with group III embryonal RMS, local failure was higher on ARST0531 than D9803 (27.9% vs 19.4%; P = .03). After the exclusion of patients 24 months old or younger or patients who did not receive radiation, local failure remained significantly increased on ARST0531 (P = .02). After adjustments for clinical prognostic factors, event-free survival and overall survival were worse on ARST0531 (P = .004 and P = .05, respectively).
CONCLUSIONS


Despite interventions designed to enhance local control, local control was inferior on ARST0531 in comparison with D9803. The reason for this is unclear, but it could be the reduced cyclophosphamide dose on ARST0531.",2019,"Despite interventions designed to enhance local control, local control was inferior on ARST0531 in comparison with D9803.","[""patients with intermediate-risk rhabdomyosarcoma (RMS) treated on Children's Oncology Group (COG) protocol ARST0531"", 'children 24\xa0months old or younger were allowed', 'patients with intermediate-risk rhabdomyosarcoma', '424 patients with intermediate-risk RMS']","['vincristine, dactinomycin, and cyclophosphamide (VAC) or VAC alternating with vincristine and irinotecan', 'radiation therapy (RT', 'Individualized local control plans']","['local failure', 'Local failure', 'clinical prognostic factors, event-free survival and overall survival', '5-year cumulative incidence of local failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",424.0,0.0297607,"Despite interventions designed to enhance local control, local control was inferior on ARST0531 in comparison with D9803.","[{'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Casey', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Yueh-Yun', 'Initials': 'YY', 'LastName': 'Chi', 'Affiliation': 'University of Florida, Gainesville, Florida.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Donaldson', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Seattle Children's Hospital, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'University of Florida, Gainesville, Florida.'}, {'ForeName': 'Carola A', 'Initials': 'CA', 'LastName': 'Arndt', 'Affiliation': 'Mayo Clinic and Foundation, Rochester, Minnesota.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Rodeberg', 'Affiliation': 'East Carolina University, Greenville, North Carolina.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Routh', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Lautz', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Abha A', 'Initials': 'AA', 'LastName': 'Gupta', 'Affiliation': 'Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Torunn I', 'Initials': 'TI', 'LastName': 'Yock', 'Affiliation': 'Massachussets General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Wolden', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Cancer,['10.1002/cncr.32204']
1392,30712404,An open-label randomized trial of intramuscular olanzapine versus oral clonidine for symptomatic treatment of opioid withdrawal in the emergency department.,"Background:  Patients with opioid withdrawal often present to the Emergency Department (ED), but many EDs do not have the infrastructure in place to initiate treatment with opioid agonists (methadone or buprenorphine). Therefore, ED management often entails symptomatic control. The purpose of this study was to compare olanzapine to clonidine for the treatment of opioid withdrawal symptoms.  Methods:  This was a prospective, randomized clinical trial comparing 10 mg of IM olanzapine to 0.3 mg of oral clonidine for symptoms of opioid withdrawal. Adult (18 years and older) ED patients reporting a history of opioid use and symptoms consistent with withdrawal were eligible. Patients were excluded if they had already received treatment during the ED encounter, were pregnant, incarcerated, or unable to provide consent. Patients were randomized 1:1 to receive olanzapine or clonidine for their initial treatment. A baseline Clinical Opiate Withdrawal Scale (COWS) score was calculated. After 30 min, the patient could receive any additional treatment at the ED physician's discretion. The primary outcome was need for additional medication (rescue) within 1 h of study medication administration. Secondary outcomes included change in COWS score and adverse reactions.  Results:  We enrolled 63 patients (33 olanzapine, 30 clonidine). Demographic characteristics were similar for both groups (median age 45, range 21-67, 54% male) as well as baseline COWS score (median score 11). The median time since last opiate use was 48 h for both groups (range 4-116). Rescue was given within 1 h for olanzapine for 9 (27%) patients and for clonidine in 19 (63%) patients (difference 36%, 95% CI 13-59%). Decrease in COWS score at 1 h was 8.3 for olanzapine and 5.1 for clonidine (difference 3.2, 95% CI 0.3-6). Adverse events were uncommon: akathisia (1, olanzapine), hypotension (2, clonidine), respiratory depression (0).  Conclusions:  Treatment of opioid withdrawal symptoms with 10 mg of IM olanzapine results in a lower incidence of rescue medication administration and improved symptoms (COWS score) compared to 0.3 mg of oral clonidine.",2019,"Adverse events were uncommon: akathisia (1, olanzapine), hypotension (2, clonidine), respiratory depression (0).  ","['Patients with opioid withdrawal often present to the Emergency Department (ED', 'Patients were excluded if they had already received treatment during the ED encounter, were pregnant, incarcerated, or unable to provide consent', 'symptomatic treatment of opioid withdrawal in the emergency department', '63 patients (33', 'Adult (18 years and older) ED patients']","['olanzapine, 30 clonidine', 'olanzapine or clonidine', 'intramuscular olanzapine', 'opioid agonists (methadone or buprenorphine', 'oral clonidine', 'clonidine', 'olanzapine', 'IM olanzapine']","['baseline Clinical Opiate Withdrawal Scale (COWS) score', 'median time since last opiate use', 'need for additional medication (rescue) within 1\u2009h of study medication administration', 'akathisia (1, olanzapine), hypotension (2, clonidine), respiratory depression (0', 'baseline COWS score', 'COWS score', 'rescue medication administration and improved symptoms (COWS score', 'change in COWS score and adverse reactions', 'Demographic characteristics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029104', 'cui_str': 'Opioid withdrawal (disorder)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4706547', 'cui_str': 'Clinical Opiate Withdrawal Scale score (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3469597', 'cui_str': 'Medication treatment'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",63.0,0.145648,"Adverse events were uncommon: akathisia (1, olanzapine), hypotension (2, clonidine), respiratory depression (0).  ","[{'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Klein', 'Affiliation': 'a Department of Emergency Medicine , Hennepin County Medical Center , Minneapolis , MN , USA.'}, {'ForeName': 'Jon B', 'Initials': 'JB', 'LastName': 'Cole', 'Affiliation': 'a Department of Emergency Medicine , Hennepin County Medical Center , Minneapolis , MN , USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Driver', 'Affiliation': 'a Department of Emergency Medicine , Hennepin County Medical Center , Minneapolis , MN , USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Miner', 'Affiliation': 'a Department of Emergency Medicine , Hennepin County Medical Center , Minneapolis , MN , USA.'}, {'ForeName': 'JoAn R', 'Initials': 'JR', 'LastName': 'Laes', 'Affiliation': 'b Minnesota Poison Control System , Minneapolis , MN , USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Fagerstrom', 'Affiliation': 'a Department of Emergency Medicine , Hennepin County Medical Center , Minneapolis , MN , USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'L Martel', 'Affiliation': 'a Department of Emergency Medicine , Hennepin County Medical Center , Minneapolis , MN , USA.'}]","Clinical toxicology (Philadelphia, Pa.)",['10.1080/15563650.2018.1547828']
1393,31180763,Long-term functional outcomes after cardiac rehabilitation in older patients. Data from the Cardiac Rehabilitation in Advanced aGE: EXercise TRaining and Active follow-up (CR-AGE EXTRA) randomised study.,"AIM


Cardiac rehabilitation promotes functional recovery after cardiac events. Our study aimed at evaluating whether, compared to usual care, a home-based exercise programme with monthly reinforcement sessions adds long-term functional benefits to those obtained with cardiac rehabilitation in the elderly.
METHODS


After a 4-week outpatient cardiac rehabilitation, 160 of 197 patients aged 75 years and older screened for eligibility with different indications for cardiac rehabilitation, were randomly assigned to a control (C) or an active treatment (T) group. During a 12-month follow-up, C patients received usual care, while T patients were prescribed a standardised set of home-based exercises with centre-based monthly reinforcements for the first 6 months. The main (peak oxygen consumption) and three secondary outcome measures (distance walked in 6 minutes, inferior limbs peak 90° Torque strength, health-related quality of life) were assessed at baseline, at random assignment and at 6 and 12-month follow-ups with the cardiopulmonary exercise test, 6-minute walking test, isokinetic dynamometer and the Short Form-36 questionnaire, respectively.
RESULTS


Both C and T groups obtained a significant and similar improvement from baseline to the end of the 4-week cardiac rehabilitation programme in the three functional outcome measures. However, at univariable and age and gender-adjusted analysis of variance for repeated measures, changes from random assignment to 6 or 12-month follow-up in any outcome measure were similar in the C and T groups.
CONCLUSION


Results from this randomised study suggest that a home-based exercise programme with monthly reinforcements does not add any long-term functional benefit beyond those offered by a conventional, 4-week outpatient cardiac rehabilitation programme.
TRIAL REGISTRATION


ClinicalTrial.gov Identifier: NCT00641134.",2019,Both C and T groups obtained a significant and similar improvement from baseline to the end of the 4-week cardiac rehabilitation programme in the three functional outcome measures.,"['Advanced aGE', '197 patients aged 75 years and older screened for eligibility with different indications for cardiac rehabilitation', 'older patients']","['Cardiac rehabilitation', 'EXercise TRaining and Active follow-up', 'usual care, while T patients were prescribed a standardised set of home-based exercises with centre-based monthly reinforcements for the first 6 months', 'control (C) or an active treatment (T) group']","['cardiopulmonary exercise test, 6-minute walking test, isokinetic dynamometer and the Short Form-36 questionnaire, respectively', 'main (peak oxygen consumption) and three secondary outcome measures (distance walked in 6 minutes, inferior limbs peak 90° Torque strength, health-related quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",197.0,0.0662752,Both C and T groups obtained a significant and similar improvement from baseline to the end of the 4-week cardiac rehabilitation programme in the three functional outcome measures.,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Pratesi', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Samuele', 'Initials': 'S', 'LastName': 'Baldasseroni', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Costanza', 'Initials': 'C', 'LastName': 'Burgisser', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Orso', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Barucci', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Maria Vittoria', 'Initials': 'MV', 'LastName': 'Silverii', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Venturini', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ungar', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Niccolò', 'Initials': 'N', 'LastName': 'Marchionni', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fattirolli', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}]",European journal of preventive cardiology,['10.1177/2047487319854141']
1394,31176028,Cluster-Randomized Trial of Opiate-Sparing Analgesia after Discharge from Elective Hip Surgery.,"BACKGROUND


Surgeons have traditionally relied on opiates after hip replacement, despite a growing epidemic of abuse. This study assessed the efficacy of multimodal analgesia and impact of conservative opiate prescribing after discharge from hip surgery.
STUDY DESIGN


In this cluster-randomized trial, 235 patients undergoing hip replacement (5 surgeons) received 1 of 3 discharge pain regimens: scheduled-dose multimodal analgesia with a minimal opiate supply (group A), scheduled-dose multimodal analgesia with a traditional opiate supply (group B), or a traditional pro re nata (as needed) opiate regimen alone (group C). Each of the surgeons comprised a distinct cluster and alternated in a randomized sequence between interventions. The multimodal regimen comprised fixed-schedule doses of acetaminophen, meloxicam, and gabapentin. Primary outcomes were daily visual analogue scale pain and opiate use for 30 days. Secondary outcomes included satisfaction, sleep quality, opiate-related symptoms, hip function, and adverse events. The primary intent-to-treat analysis was performed using linear mixed models.
RESULTS


Daily pain was significantly lower in group A (coefficient [Coeff] -0.81; p = 0.003) and group B (Coeff -0.61; p = 0.021) relative to group C. Although daily opiate use in group A (Coeff -0.77; p < 0.001) and group B (Coeff -0.30; p = 0.04) was lower than group C, opiate use for group A was also lower than group B (Coeff -0.46; p = 0.002). Duration of opiate use was significantly shorter for group A (1.14 weeks) and group B (1.39 weeks) compared with group C (2.57 weeks). There were fewer opiate-related symptoms, most commonly fatigue, in group A compared with C, but groups B and C were not significantly different. Both multimodal regimens improved satisfaction and sleep, and there were no differences in hip function or adverse events.
CONCLUSIONS


Multimodal analgesia with minimal opiates improved pain control while significantly decreasing opiate use and opiate-related adverse effects. It is time to rethink our reliance on opiates after elective operations.",2019,"RESULTS


Daily pain was significantly lower in Group A (Coeff -0.81,p=0.003) and Group B (Coeff -0.61,p=0.021) relative to Group C.","['235 patients undergoing hip replacement (five surgeons', 'after Discharge from Elective Hip Surgery']","['acetaminophen, meloxicam, and gabapentin', 'Opiate-Sparing Analgesia', 'discharge pain regimens: scheduled-dose multimodal analgesia with a minimal opiate supply (Group-A), scheduled-dose multimodal analgesia with a traditional opiate supply(Group-B), or a traditional PRN opiate regimen alone(Group-C']","['satisfaction, sleep-quality, opiate-related symptoms, hip function, and adverse events', 'hip function or adverse events', 'Duration of opiate use', 'pain control', 'daily VAS pain and opiate utilization for 30-days', 'Daily pain', 'satisfaction and sleep']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392806', 'cui_str': 'Hip Prosthesis Implantation'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0558288', 'cui_str': 'prn'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",235.0,0.114428,"RESULTS


Daily pain was significantly lower in Group A (Coeff -0.81,p=0.003) and Group B (Coeff -0.61,p=0.021) relative to Group C.","[{'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Fleischman', 'Affiliation': 'Department of Anesthesia, Thomas Jefferson University, Philadelphia, PA. Electronic address: anfleischman@gmail.com.'}, {'ForeName': 'Majd', 'Initials': 'M', 'LastName': 'Tarabichi', 'Affiliation': 'Rothman Institute, Philadelphia, PA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Foltz', 'Affiliation': 'Rothman Institute, Philadelphia, PA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Makar', 'Affiliation': 'Rothman Institute, Philadelphia, PA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Hozack', 'Affiliation': 'Rothman Institute, Philadelphia, PA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Austin', 'Affiliation': 'Rothman Institute, Philadelphia, PA.'}, {'ForeName': 'Antonia F', 'Initials': 'AF', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedics, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2019.05.026']
1395,31178217,Cost-effectiveness analysis of gemcitabine plus cisplatin versus fluorouracil plus cisplatin for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.,"PURPOSE


Compared with conventional fluorouracil plus cisplatin (FP) regimen, gemcitabine plus cisplatin (GP) can prolong survival in patients with recurrent or metastatic nasopharyngeal carcinoma, but the economic impact of this practice remains unknown. It's significant to evaluate its values by taking both efficacy and cost into consideration.
METHODS


We developed a Markov model with 10 years horizon to compare the cost-effectiveness of GP and FP regimen. Clinical data came from a multicentre, randomised, open-label, phase 3 trial. Direct costs related to the treatment were estimated from the perspective of the Chinese healthcare system. Utility values were gathered from published study. Sensitivity analysis was conducted to confirm the robustness of the model.
RESULTS


The total cost of FP regimen was $12,587 and yielded 0.964 QALYs, while the total cost of GP regimen was $17,920 and yielded 1.685 QALYs. The ICER of GP regimen versus FP regimen was $7,386 which was far less than the willingness-to-pay threshold ($26,508) in China.
CONCLUSION


From the perspective of Chinese healthcare system, GP regimen with superior efficacy was proved to be more cost-effective than the traditional FP regimen. It is likely that GP regimen may be recommended as the primarily first-line treatment option for recurrent or metastatic nasopharyngeal carcinoma.",2019,"The total cost of FP regimen was $12,587 and yielded 0.964 QALYs, while the total cost of GP regimen was $17,920 and yielded 1.685 QALYs.","['recurrent or metastatic nasopharyngeal carcinoma', 'patients with recurrent or metastatic nasopharyngeal carcinoma']","['conventional fluorouracil plus cisplatin (FP) regimen, gemcitabine plus cisplatin', 'gemcitabine plus cisplatin versus fluorouracil plus cisplatin', 'GP']","['total cost of FP regimen', 'cost-effective', 'total cost of GP regimen']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",,0.0186088,"The total cost of FP regimen was $12,587 and yielded 0.964 QALYs, while the total cost of GP regimen was $17,920 and yielded 1.685 QALYs.","[{'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'College of Pharmacy, Jinan University, Guangzhou 510632, China.'}, {'ForeName': 'Weiting', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Department of Pharmacy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; State Key Laboratory of Oncology in South China, Sun Yat-sen University, Guangzhou 510060, China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University, Guangzhou 510060, China; Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University, Guangzhou 510060, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wan', 'Affiliation': 'Department of Pharmacy, General Hospital of Guangzhou Military Command, 510010, China; Guangzhou Huabo Biopharmaceutical Research Institute, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Sun Yat-sen University, Guangzhou 510060, China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University, Guangzhou 510060, China; Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University, Guangzhou 510060, China; Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, China.'}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Sun Yat-sen University, Guangzhou 510060, China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University, Guangzhou 510060, China; Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University, Guangzhou 510060, China; Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, China. Electronic address: yangyp@sysucc.org.cn.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'College of Pharmacy, Jinan University, Guangzhou 510632, China; International Cooperative Laboratory of Traditional Chinese Medicine Modernization and Innovative Drug Development of Chinese Ministry of Education (MOE), Jinan University, Guangzhou 510632, China; Dongguan Institute of Jinan University, China. Electronic address: jiangjie@jnu.edu.cn.'}, {'ForeName': 'Tiantian', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'College of Pharmacy, Jinan University, Guangzhou 510632, China; International Cooperative Laboratory of Traditional Chinese Medicine Modernization and Innovative Drug Development of Chinese Ministry of Education (MOE), Jinan University, Guangzhou 510632, China. Electronic address: zhangtiantian@jnu.edu.cn.'}]",Oral oncology,['10.1016/j.oraloncology.2019.04.022']
1396,31178377,"A randomized, open-labelled, non-inferiority phase 4 clinical trial to evaluate the immunogenicity and safety of the live, attenuated, oral rotavirus vaccine, ROTAVAC® in comparison with a licensed rotavirus vaccine in healthy infants.","BACKGROUND


ROTAVAC® (nHRV), derived naturally from the human 116E rotavirus (RV) neonatal strain, was licensed in India in 2015 based on promising results of a phase 3, safety and efficacy vaccine trial. As a pre-requisite for WHO prequalification, we compared the immunogenicity and safety of ROTAVAC® to those of a WHO-prequalified, Rotarix®.
METHODS


We conducted a multicentre, open-labeled, randomized phase 4 clinical trial where 464 infants, 6-8 weeks of age were equally randomized to receive as licensed, the complete regimen of ROTAVAC® (3 doses; Group I) or Rotarix® (2 doses; Group II). Antibody responses (serum anti-RV Immunoglobulin A [IgA]) were measured by enzyme-linked immunosorbent assay (ELISA). The primary analysis was an assessment of non-inferiority of ROTAVAC® to Rotarix® for geometric mean concentration (GMC) for infants who received the complete regimen of either vaccine.
RESULTS


The GMC for Group I was 20.4 (95%CI: 17.6, 23.6) and that for Group II was 24.8 (95%CI: 20.3, 30.3), the GMC ratio was 0.82 (95% CI: 0.64, 1.05), thus meeting the non-inferiority criterion. Site-wise analysis of GMC titres revealed that one site had a peculiar pre-vaccination titre affecting only ROTAVAC® post-vaccination GMCs. Seroconversion rates were 35.3% (95%CI: 29.0, 41.9) and 31.0% (95%CI: 25.1, 37.4) for Groups I and Group II, respectively. There was no substantive difference in safety profiles between both vaccines.
CONCLUSIONS


The complete regimen of ROTAVAC® demonstrated immunological non-inferiority to the complete regimen of Rotarix® with a clinically acceptable safety profile. Because the demand for RV vaccines is increasing as more countries are expanding their immunization schedules, the lack of need of a buffering agent, low dose volume (0.5 mL), non-interference with other concomitantly administered vaccines, and conformance with WHO-prequalification requirements provide ROTAVAC® the potential for widespread global usage. Post completion of this study, ROTAVAC® is now a WHO-prequalified vaccine.
CLINICAL TRIALS REGISTRATION


(CTRI Number: CTRI/2015/12/006428).",2019,The complete regimen of ROTAVAC® demonstrated immunological non-inferiority to the complete regimen of Rotarix® with a clinically acceptable safety profile.,"['464 infants, 6-8\u202fweeks of age', 'healthy infants']","['oral rotavirus vaccine, ROTAVAC®', 'ROTAVAC®', 'Rotarix®']","['Antibody responses (serum anti-RV Immunoglobulin A [IgA', 'Seroconversion rates', 'GMC ratio', 'immunogenicity and safety', 'safety profiles']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C1528012', 'cui_str': 'Rotarix'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",464.0,0.23004,The complete regimen of ROTAVAC® demonstrated immunological non-inferiority to the complete regimen of Rotarix® with a clinically acceptable safety profile.,"[{'ForeName': 'Raches', 'Initials': 'R', 'LastName': 'Ella', 'Affiliation': 'Bharat Biotech International Limited, Genome Valley, Shameerpet, Hyderabad, India.'}, {'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Babji', 'Affiliation': 'Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Ciarlet', 'Affiliation': 'Independent Clinical Development Consultant, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Blackwelder', 'Affiliation': 'Independent Clinical Development Consultant, USA.'}, {'ForeName': 'Krishna Mohan', 'Initials': 'KM', 'LastName': 'Vadrevu', 'Affiliation': 'Bharat Biotech International Limited, Genome Valley, Shameerpet, Hyderabad, India. Electronic address: kmohan@bharatbiotech.com.'}]",Vaccine,['10.1016/j.vaccine.2019.05.069']
1397,31176540,Protective effect of PCV vaccine against experimental pneumococcal challenge in adults is primarily mediated by controlling colonisation density.,"Widespread use of Pneumococcal Conjugate Vaccines (PCV) has reduced vaccine-type nasopharyngeal colonisation and invasive pneumococcal disease. In a double-blind, randomised controlled trial using the Experimental Human Pneumococcal Challenge (EHPC) model, PCV-13 (Prevenar-13) conferred 78% protection against colonisation acquisition and reduced bacterial intensity (AUC) as measured by classical culture. We used a multiplex qPCR assay targeting lytA and pneumococcal serotype 6A/B cpsA genes to re-assess the colonisation status of the same volunteers. Increase in detection of low-density colonisation resulted in reduced PCV efficacy against colonisation acquisition (29%), compared to classical culture (83%). For experimentally colonised volunteers, PCV had a pronounced effect on decreasing colonisation density. These results obtained in adults suggest that the success of PCV vaccination could primarily be mediated by the control of colonisation density. Studies assessing the impact of pneumococcal vaccines should allow for density measurements in their design.",2019,"Increase in detection of low-density colonisation resulted in reduced PCV efficacy against colonisation acquisition (29%), compared to classical culture (83%).",[],"['multiplex qPCR assay targeting lytA and pneumococcal serotype 6A/B cpsA', 'PCV vaccine', 'Pneumococcal Conjugate Vaccines (PCV', 'Experimental Human Pneumococcal Challenge (EHPC) model, PCV-13 (Prevenar-13']","['colonisation density', 'PCV efficacy against colonisation acquisition', 'bacterial intensity (AUC']",[],"[{'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C2756364', 'cui_str': 'Prevnar 13'}]","[{'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",,0.128852,"Increase in detection of low-density colonisation resulted in reduced PCV efficacy against colonisation acquisition (29%), compared to classical culture (83%).","[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'German', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: Esther.German@lstmed.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Solórzano', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: Carla.SolorzanoGonzalez@lstmed.ac.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sunny', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: syba.sunny@rlbuht.nhs.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dunne', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: f.j.dunne@bham.ac.uk.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Gritzfeld', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: j.gritzfeld@liverpool.ac.uk.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mitsi', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: Elena.Mitsi@lstmed.ac.uk.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nikolaou', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: Elissavet.Nikolaou@lstmed.ac.uk.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Hyder-Wright', 'Affiliation': 'Royal Liverpool University Hospital, Liverpool, United Kingdom. Electronic address: Angela.Hyder-Wright@lstmed.ac.uk.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Collins', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: Andrea.Collins@lstmed.ac.uk.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Gordon', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: sgordon@mlw.mw.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Ferreira', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: Daniela.Ferreira@lstmed.ac.uk.'}]",Vaccine,['10.1016/j.vaccine.2019.05.080']
1398,31101700,"Effectiveness of antitussives, anticholinergics or honey versus usual care in adults with uncomplicated acute bronchitis: a study protocol of an open randomised clinical trial in primary care.","INTRODUCTION


Despite the frequent use of therapies in acute bronchitis, the evidence of their benefit is lacking, since only a few clinical trials have been published, with low sample sizes, poor methodological quality and mainly in children. The objective of this study is to compare the effectiveness of three symptomatic therapies (dextromethorphan, ipratropium or honey) associated with usual care and the usual care in adults with acute bronchitis.
METHODS AND ANALYSIS


This will be a multicentre, pragmatic, parallel group, open randomised trial. Patients aged 18 or over with uncomplicated acute bronchitis, with cough for less than 3 weeks as the main symptom, scoring ≥4 in either daytime or nocturnal cough on a 7-point Likert scale, will be randomised to one of the following four groups: usual care, dextromethorphan 30 mg three times a day, ipratropium bromide inhaler 20 µg two puffs three times a day or honey 30 mg (a spoonful) three times a day, all taken for up to 14 days. The exclusion criteria will be pneumonia, criteria for hospital admission, pregnancy or lactation, concomitant pulmonary disease, associated significant comorbidity, allergy, intolerance or contraindication to any of the study drugs or admitted to a long-term residence.
SAMPLE


668 patients. The primary outcome will be the number of days with moderate-to-severe cough. All patients will be given a paper-based symptom diary to be self-administered. A second visit will be scheduled at day 2 or 3 for assessing evolution, with two more visits at days 15 and 29 for clinical assessment, evaluation of adverse effects, re-attendance and complications. Patients still with symptoms at day 29 will be called 6 weeks after the baseline visit.
ETHICS AND DISSEMINATION


The study has been approved by the Ethical Board of IDIAP Jordi Gol (reference number: AC18/002). The findings of this trial will be disseminated through research conferences and peer-review journals.
TRIAL REGISTRATION NUMBER


NCT03738917; Pre-results.",2019,"Patients aged 18 or over with uncomplicated acute bronchitis, with cough for less than 3 weeks as the main symptom, scoring ≥4 in either daytime or nocturnal cough on a 7-point Likert scale, will be randomised to one of the following four groups: usual care, dextromethorphan 30 mg three times a day, ipratropium bromide inhaler 20 µg two puffs three times a day or honey 30 ","['adults with uncomplicated acute bronchitis', 'adults with acute bronchitis', 'SAMPLE\n\n\n668 patients', 'Patients aged 18 or over with uncomplicated acute bronchitis, with cough for less than 3\u2009weeks as the main symptom, scoring ≥4 in either daytime or nocturnal cough on a 7-point Likert scale']","['usual care, dextromethorphan 30\u2009mg three times a day, ipratropium bromide inhaler 20\u2009µg two puffs three times a day or honey 30', 'symptomatic therapies (dextromethorphan, ipratropium or honey', 'antitussives, anticholinergics or honey versus usual care']",['number of days with moderate-to-severe cough'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149514', 'cui_str': 'Acute tracheobronchitis (disorder)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0231912', 'cui_str': 'Nocturnal cough (finding)'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}]","[{'cui': 'C1123847', 'cui_str': 'Dextromethorphan 30 MG'}, {'cui': 'C0556984', 'cui_str': 'Three times daily (qualifier value)'}, {'cui': 'C0700580', 'cui_str': 'Ipratropium Bromide'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0027235', 'cui_str': 'Ipratropium'}, {'cui': 'C0003449', 'cui_str': 'Antitussives'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}]",668.0,0.254708,"Patients aged 18 or over with uncomplicated acute bronchitis, with cough for less than 3 weeks as the main symptom, scoring ≥4 in either daytime or nocturnal cough on a 7-point Likert scale, will be randomised to one of the following four groups: usual care, dextromethorphan 30 mg three times a day, ipratropium bromide inhaler 20 µg two puffs three times a day or honey 30 ","[{'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Cots', 'Affiliation': 'Primary Healthcare Centre La Marina, Barcelona, Spain, Universitat de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Moragas', 'Affiliation': 'Primary Healthcare Centre Jaume I, Universitat Rovira i Virgili, Tarragona, Catalonia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'García-Sangenís', 'Affiliation': ""Medicines Research Unit, Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Catalonia.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Morros', 'Affiliation': ""Medicines Research Unit, Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Catalonia.""}, {'ForeName': 'Ainhoa', 'Initials': 'A', 'LastName': 'Gomez-Lumbreras', 'Affiliation': ""Medicines Research Unit, Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Catalonia.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ouchi', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària (IDIAP) Jordi Gol, Barcelona, Catalonia.""}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Monfà', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària (IDIAP) Jordi Gol, Barcelona, Catalonia.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Pera', 'Affiliation': ""Medicines Research Unit, Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Catalonia.""}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Pujol', 'Affiliation': 'Balaguer Health Centre, Balaguer, Catalonia.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Bayona', 'Affiliation': 'Primary Healthcare Centre La Marina, Barcelona, Catalonia.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'de la Poza-Abad', 'Affiliation': 'Institut Català de la Salut, Barcelona, Catalonia.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Llor', 'Affiliation': 'Primary Healthcare Centre Barcelona-2B (via Roma), Barcelona, Catalonia.'}]",BMJ open,['10.1136/bmjopen-2018-028159']
1399,30987919,Alaska Native Children Do Not Prefer Sugar-Sweetened Fruit Drinks to Sugar-Free Fruit Drinks.,"BACKGROUND


Alaska Native children, including children of Yup'ik descent, consume large volumes of sugar-sweetened fruit drinks, which contain added sugars that contribute to obesity, diabetes, and dental caries. To date, taste preference evaluations have not been conducted on commercially available sugar-free fruit drinks.
OBJECTIVE


The study tested the hypothesis that children would have equal preference for sugar-free and sugar-sweetened fruit drinks.
DESIGN


This was an experimental two-alternative forced-choice paired preference test.
PARTICIPANTS/SETTING


The study focused on a convenience sample of Yup'ik children, aged 7 to 10 years, recruited and enrolled from the Yukon-Kuskokwim Health Corporation dental clinic in Bethel, AK (N=89).
INTERVENTION


Children evaluated four different commercially available sugar-free fruit drinks paired with the sugar-sweetened versions of each flavor. Order of flavor pair presentation was alternated across children, and order of presentation within each of the four pairs was randomized across pairs.
MAIN OUTCOME MEASURES


The outcome was taste preference for the sugar-free versus the sugar-sweetened version of a fruit drink.
STATISTICAL ANALYSES PERFORMED


A test of equivalence was run across all four flavors and separately for each flavor using two one-sided tests.
RESULTS


The data failed to demonstrate equivalence of the sugar-free and sugar-sweetened fruit drinks across all four flavors (P=0.51) or separately for each flavor. However, this was not because of a preference for sugar-sweetened drinks. The preference for sugar-free drinks overall and for each flavor was >50%. Although the lower bounds of the 90% CIs were within the range of equivalence (40% to 60%), the upper bounds were outside the range of equivalence (>60%). According to post hoc analyses, similar preferences were observed for Yup'ik and non-Yup'ik children, boys and girls, and children of different ages.
CONCLUSIONS


Taste preference findings suggest that sugar-free fruit drinks may be a well-tolerated alternative to sugar-sweetened fruit drinks for Yup'ik children in Alaska Native communities.",2019,The data failed to demonstrate equivalence of the sugar-free and sugar-sweetened fruit drinks across all four flavors (P=0.51) or separately for each flavor.,"['Alaska Native Children', ""convenience sample of Yup'ik children, aged 7 to 10 years, recruited and enrolled from the Yukon-Kuskokwim Health Corporation dental clinic in Bethel, AK (N=89"", ""Alaska Native children, including children of Yup'ik descent""]",['Children evaluated four different commercially available sugar-free fruit drinks paired with the sugar-sweetened versions of each flavor'],[],"[{'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043438', 'cui_str': 'Yukon'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011344', 'cui_str': 'Dental Clinics'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]",[],,0.0410088,The data failed to demonstrate equivalence of the sugar-free and sugar-sweetened fruit drinks across all four flavors (P=0.51) or separately for each flavor.,"[{'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Chi', 'Affiliation': ''}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Coldwell', 'Affiliation': ''}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Mancl', 'Affiliation': ''}, {'ForeName': 'Scarlett', 'Initials': 'S', 'LastName': 'Hopkins', 'Affiliation': ''}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Senturia', 'Affiliation': ''}, {'ForeName': 'Cameron L', 'Initials': 'CL', 'LastName': 'Randall', 'Affiliation': ''}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Orr', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Cruz', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.02.007']
1400,30680633,A pilot randomized controlled trial of 6-week combined exercise program on fasting insulin and fitness levels in individuals with spinal cord injury.,"PURPOSE


The aim of this randomized controlled trial study was to investigate the effect of combined exercise program on the fasting insulin and fitness levels of people with spinal cord injury (SCI).
METHODS


A total of 19 individuals with SCI participated in a combined exercise program consisting of aerobic and resistance exercises for 60 min per day, 3 days per week for 6 weeks. Peak oxygen consumption, body mass index, percent body fat, waist circumference, shoulder abduction and adduction, shoulder flexion and extension, elbow flexion and extension, fasting insulin levels, and homeostasis model assessment of insulin resistance (HOMA-IR) levels were measured at baseline and after the intervention.
RESULTS


The 6-week exercise program significantly decreased the average fasting insulin (baseline: 7.5 ± 4.7 µU/ml vs. post-intervention: 4.5 ± 2.2 µU/ml, p < 0.05) and HOMA-IR (baseline: 1.5 ± 1.0 vs. post-intervention: 0.9 ± 0.4, p < 0.05) in the exercise group, whereas there was no change in control group (between group difference, mean fasting insulin: - 3.2 µU/ml, p = 0.003; mean HOMA-IR: - 0.66, p = 0.001). In addition, muscle strength of the shoulder flexors, extensors, abductors, adductors, and elbow flexors was significantly improved in the exercise group compared to the controls.
CONCLUSION


A combined exercise program is effective in decreasing fasting insulin and HOMA-IR levels while improving fitness in those with SCI. These slides can be retrieved under Electronic Supplementary Material.",2019,A combined exercise program is effective in decreasing fasting insulin and HOMA-IR levels while improving fitness in those with SCI.,"['people with spinal cord injury (SCI', '19 individuals with SCI participated in a', 'individuals with spinal cord injury']","['combined exercise program', 'combined exercise program consisting of aerobic and resistance exercises']","['Peak oxygen consumption, body mass index, percent body fat, waist circumference, shoulder abduction and adduction, shoulder flexion and extension, elbow flexion and extension, fasting insulin levels, and homeostasis model assessment of insulin resistance (HOMA-IR) levels', 'fasting insulin and HOMA-IR levels', 'average fasting insulin', 'fasting insulin and fitness levels', 'mean fasting insulin', 'muscle strength of the shoulder flexors, extensors, abductors, adductors, and elbow flexors', 'HOMA-IR']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231457', 'cui_str': 'Adduction, function (observable entity)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",19.0,0.0718928,A combined exercise program is effective in decreasing fasting insulin and HOMA-IR levels while improving fitness in those with SCI.,"[{'ForeName': 'Dong-Il', 'Initials': 'DI', 'LastName': 'Kim', 'Affiliation': 'Department of Professional Therapy, Graduate School of Professional Therapy, Gachon University, Seongnam, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Can Ozan', 'Initials': 'CO', 'LastName': 'Tan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hyuna', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Sport Industry Studies, Exercise Medicine and Rehabilitation Laboratory, Yonsei University, 50 Yonsei-Ro, Seodaemun-Gu, Seoul, 120-749, Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': ""Korea Disabled People's Development Institute, Seoul, Korea.""}, {'ForeName': 'Sang-Yong', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Education, Gachon University, Seongnam, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Kyong-Mee', 'Initials': 'KM', 'LastName': 'Chung', 'Affiliation': 'Department of Psychology, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Young-Hee', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Yonsei University Wonju College of Medicine, Wonju, Gangwon-do, Korea.'}, {'ForeName': 'Bum-Suk', 'Initials': 'BS', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Hospital, Seoul, Korea.'}, {'ForeName': 'Justin Y', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Department of Sport Industry Studies, Exercise Medicine and Rehabilitation Laboratory, Yonsei University, 50 Yonsei-Ro, Seodaemun-Gu, Seoul, 120-749, Korea. jjeon@yonsei.ac.kr.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-05885-7']
1401,31174993,"Adjunctive liraglutide treatment in patients with persistent or recurrent type 2 diabetes after metabolic surgery (GRAVITAS): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Many patients with type 2 diabetes do not achieve sustained diabetes remission after metabolic (bariatric) surgery for the treatment of obesity. Liraglutide, a glucagon-like peptide-1 analogue, improves glycaemic control and reduces bodyweight in patients with type 2 diabetes. Our aim was to assess the safety and efficacy of liraglutide 1·8 mg in patients with persistent or recurrent type 2 diabetes after metabolic surgery.
METHODS


In the GRAVITAS randomised double-blind, placebo-controlled trial, we enrolled adults who had undergone Roux-en-Y gastric bypass or vertical sleeve gastrectomy and had persistent or recurrent type 2 diabetes with HbA 1c  levels higher than 48 mmol/mol (6·5%) at least 1 year after surgery from five hospitals in London, UK. Participants were randomly assigned (2:1) via a computer-generated sequence to either subcutaneous liraglutide 1·8 mg once daily or placebo, both given together with a reduced-calorie diet, aiming for a 500 kcal per day deficit from baseline energy intake, and increased physical activity. The primary outcome was the change in HbA 1c  from baseline to the end of the study period at 26 weeks, assessed in patients who completed the trial. Safety was assessed in the safety analysis population, consisting of all participants who received either liraglutide or placebo. This trial is registered with EudraCT, number 2014-003923-23, and the ISRCTN registry, number ISRCTN13643081.
FINDINGS


Between Jan 29, 2016, and May 2, 2018, we assigned 80 patients to receive either liraglutide (n=53) or placebo (n=27). 71 (89%) participants completed the study and were included in the principal complete-cases analysis. In a multivariable linear regression analysis, with baseline HbA 1c  levels and surgery type as covariates, liraglutide treatment was associated with a difference of -13·3 mmol/mol (-1·22%, 95% CI -19·7 to -7·0; p=0·0001) in HbA 1c  change from baseline to 26 weeks, compared with placebo. Type of surgery had no significant effect on the outcome. 24 (45%) of 53 patients assigned to liraglutide and 11 (41%) of 27 assigned to placebo reported adverse effects: these were mainly gastrointestinal and in line with previous experience with liraglutide. There was one death during the study in a patient assigned to the placebo group, which was considered unrelated to study treatment.
INTERPRETATION


These findings support the use of adjunctive liraglutide treatment in patients with persistent or recurrent type 2 diabetes after metabolic surgery.
FUNDING


JP Moulton Foundation.",2019,"Liraglutide, a glucagon-like peptide-1 analogue, improves glycaemic control and reduces bodyweight in patients with type 2 diabetes.","['Between Jan 29, 2016, and May 2, 2018', 'patients with persistent or recurrent type 2 diabetes after metabolic surgery', 'enrolled adults who had undergone Roux-en-Y gastric bypass or vertical sleeve gastrectomy and had persistent or recurrent type 2 diabetes with HbA 1c  levels higher than 48 mmol/mol (6·5%) at least 1 year after surgery from five hospitals in London, UK', 'patients with type 2 diabetes', 'patients with persistent or recurrent type 2 diabetes after metabolic surgery (GRAVITAS']","['placebo', 'subcutaneous liraglutide 1·8 mg once daily or placebo, both given together with a reduced-calorie diet', 'liraglutide or placebo', 'Liraglutide, a glucagon-like peptide-1 analogue', 'liraglutide', 'Adjunctive liraglutide']","['change in HbA 1c', 'safety and efficacy', 'adverse effects', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet (finding)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",80.0,0.725018,"Liraglutide, a glucagon-like peptide-1 analogue, improves glycaemic control and reduces bodyweight in patients with type 2 diabetes.","[{'ForeName': 'Alexander Dimitri', 'Initials': 'AD', 'LastName': 'Miras', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Pérez-Pevida', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Madhawi', 'Initials': 'M', 'LastName': 'Aldhwayan', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kamocka', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Emma Rose', 'Initials': 'ER', 'LastName': 'McGlone', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Werd', 'Initials': 'W', 'LastName': 'Al-Najim', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK; Diabetes Complications Research Centre, Conway Institute, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Harvinder', 'Initials': 'H', 'LastName': 'Chahal', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Batterham', 'Affiliation': 'Centre for Obesity Research, Rayne Institute, Department of Medicine, University College London, London, UK; Bariatric Centre for Weight Management and Metabolic Surgery and National Institute for Health Research Biomedical Research Centre, University College London Hospital, London, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McGowan', 'Affiliation': ""Diabetes and Endocrinology, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Khan', 'Affiliation': ""Surgery, St George's University Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Greener', 'Affiliation': 'Diabetes and Endocrinology, Chelsea and Westminster Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ahmed R', 'Initials': 'AR', 'LastName': 'Ahmed', 'Affiliation': 'Department of Surgery & Cancer, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Aviva', 'Initials': 'A', 'LastName': 'Petrie', 'Affiliation': 'Eastman Dental Institute, University College London, London, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Scholtz', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Bloom', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Tricia M', 'Initials': 'TM', 'LastName': 'Tan', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK. Electronic address: t.tan@imperial.ac.uk.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30157-3']
1402,30430372,Efficacy of vitamin D replacement therapy in restless legs syndrome: a randomized control trial.,"PURPOSE


Restless legs syndrome is a movement sleep disorder that may be linked to dopaminergic dysfunction and in which vitamin D may play a role. This 12-week randomized, placebo-controlled trial elucidated the efficacy of vitamin D supplements in decreasing restless legs syndrome symptom severity.
METHODS


Thirty-five subjects with restless legs syndrome, diagnosed using the International Restless Legs Syndrome Study Group criteria, were enrolled. The subjects were randomized to orally receive either vitamin D (50,000 IU caplets) or a placebo. All medications were administered weekly using a direct observation technique. Clinical assessments, including those for restless legs syndrome severity, were conducted at baseline and the end of the study using the International Restless Legs Syndrome Study Group rating scale. The serum vitamin D levels and bone profiles were measured at baseline and every 4 weeks. The primary endpoint was the change in the restless legs syndrome severity score from baseline to week 12. There were 17 and 18 patients in the vitamin D and placebo groups, respectively.
RESULTS


The groups did not differ with respect to age, sex, restless legs syndrome severity, or vitamin D levels. Participants in the vitamin D group showed no significant change in the mean restless legs syndrome severity score compared with the placebo group.
CONCLUSIONS


The results suggest that vitamin D supplementation does not improve restless legs syndrome symptoms.
CLINICAL TRIAL REGISTRATION NUMBER


ClinicalTrials.gov : NCT02256215 (available from: https://clinicaltrials.gov/ct2/show/NCT02256215 ).",2019,"Participants in the vitamin D group showed no significant change in the mean restless legs syndrome severity score compared with the placebo group.
","['restless legs syndrome', 'Thirty-five subjects with restless legs syndrome, diagnosed using the International Restless Legs Syndrome Study Group criteria, were enrolled']","['vitamin D', 'vitamin D and placebo', 'vitamin D supplementation', 'placebo', 'vitamin D replacement therapy', 'vitamin D supplements']","['restless legs syndrome severity, or vitamin D levels', 'restless legs syndrome symptom severity', 'restless legs syndrome symptoms', 'restless legs syndrome severity score', 'serum vitamin D levels and bone profiles', 'mean restless legs syndrome severity score']","[{'cui': 'C3887611', 'cui_str': 'Restlessness (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0035258', 'cui_str': 'Wittmaack Ekbom Syndrome'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}]","[{'cui': 'C3887611', 'cui_str': 'Restlessness (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0430041', 'cui_str': 'Bone profile (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",35.0,0.59207,"Participants in the vitamin D group showed no significant change in the mean restless legs syndrome severity score compared with the placebo group.
","[{'ForeName': 'Siraj Omar', 'Initials': 'SO', 'LastName': 'Wali', 'Affiliation': 'Sleep Medicine Research Group, Sleep Medicine and Research Center, College of Medicine, King Abdulaziz University Hospital, P.O. Box 21589, Jeddah, 80215, Saudi Arabia. sowali@kau.edu.sa.'}, {'ForeName': 'Bahaa', 'Initials': 'B', 'LastName': 'Abaalkhail', 'Affiliation': 'Family and Community Medicine Department, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Faris', 'Initials': 'F', 'LastName': 'Alhejaili', 'Affiliation': 'Sleep Medicine Research Group, Sleep Medicine and Research Center, College of Medicine, King Abdulaziz University Hospital, P.O. Box 21589, Jeddah, 80215, Saudi Arabia.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Pandi-Perumal', 'Affiliation': 'Somnogen Canada Inc., College Street, Toronto, ON, Canada.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-018-1751-2']
1403,31762463,Transcranial Direct Current Stimulation for Online Gamers.,"Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that applies a weak electric current to the scalp to modulate neuronal membrane potentials. Compared to other brain stimulation methods, tDCS is relatively safe, simple, and inexpensive to administer. Since excessive online gaming can negatively affect mental health and daily functioning, developing treatment options for gamers is necessary. Although tDCS over the dorsolateral prefrontal cortex (DLPFC) has demonstrated promising results for various addictions, it has not been tested in gamers. This paper describes a protocol and a feasibility study for applying repeated tDCS over the DLPFC and neuroimaging to examine the underlying neural correlates in gamers. At baseline, individuals who play online games report average weekly hours spent on games, complete questionnaires on addiction symptoms and self-control, and undergo brain  18 F-fluoro-2-deoxyglucose positron emission tomography (FDG-PET). The tDCS protocol consists of 12 sessions over the DLPFC for 4 weeks (anode F3/cathode F4, 2 mA for 30 min per session). Then, a follow-up is conducted using the same protocol as the baseline. Individuals who do not play online games receive only baseline FDG-PET scans without tDCS. Changes of clinical characteristics and asymmetry of regional cerebral metabolic rate of glucose (rCMRglu) in the DLPFC are examined in gamers. In addition, asymmetry of rCMRglu is compared between gamers and non-gamers at baseline. In our experiment, 15 gamers received tDCS sessions and completed baseline and follow-up scans. Ten non-gamers underwent FDG-PET scans at the baseline. The tDCS reduced addiction symptoms, time spent on games, and increased self-control. Moreover, abnormal asymmetry of rCMRglu in the DLPFC at baseline was alleviated after tDCS. The current protocol may be useful for assessing treatment efficacy of tDCS and its underlying brain changes in gamers. Further randomized sham-controlled studies are warranted. Moreover, the protocol can be applied to other neurological and psychiatric disorders.",2019,"The tDCS reduced addiction symptoms, time spent on games, and increased self-control.","['Online Gamers', 'gamers', 'Individuals who do not play online games receive only baseline FDG-PET scans without tDCS']","['Transcranial Direct Current Stimulation', 'tDCS', 'Transcranial direct current stimulation (tDCS']","['regional cerebral metabolic rate of glucose (rCMRglu', 'addiction symptoms, time spent on games, and increased self-control']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0577490', 'cui_str': 'Does not play (finding)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}]",,0.0438511,"The tDCS reduced addiction symptoms, time spent on games, and increased self-control.","[{'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': ""Department of Radiology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea.""}, {'ForeName': 'Jooyeon Jamie', 'Initials': 'JJ', 'LastName': 'Im', 'Affiliation': ""Department of Radiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea.""}, {'ForeName': 'Jin Kyoung', 'Initials': 'JK', 'LastName': 'Oh', 'Affiliation': ""Department of Radiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea.""}, {'ForeName': 'Eun Kyoung', 'Initials': 'EK', 'LastName': 'Choi', 'Affiliation': ""Department of Radiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea.""}, {'ForeName': 'Sujung', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Department of Brain and Cognitive Sciences, Ewha Womans University.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York.'}, {'ForeName': 'In-Uk', 'Initials': 'IU', 'LastName': 'Song', 'Affiliation': ""Department of Neurology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea.""}, {'ForeName': 'Hyeonseok', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': ""Department of Radiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea; hsjeong@catholic.ac.kr.""}, {'ForeName': 'Yong-An', 'Initials': 'YA', 'LastName': 'Chung', 'Affiliation': ""Department of Radiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea; yongan@catholic.ac.kr.""}]",Journal of visualized experiments : JoVE,['10.3791/60007']
1404,30565198,Acoustic Neurofeedback Increases Beta ERD During Mental Rotation Task.,"The purpose of the present study was to identify the effect of acoustic neurofeedback on brain activity during consecutive stages of mental rotation of 3D objects. Given the fact that the process of mental rotation of objects is associated with desynchronisation of beta rhythm (beta ERD), it was expected that suppression in this band would be greater in the experimental group than in the controls. Thirty-three participants were randomly allocated to two groups performing the classic Shepard-Metzler mental rotation task (1971). The experimental group received auditory stimuli when the level of concentration fell below the threshold value determined separately for each participant based on the engagement index [β/(α + Θ)]. The level of concentration in the control group was not stimulated. Compared to the controls, the experimental group was found with greater beta-band suppression recorded above the left parietal cortex during the early stage and above the right parietal cortex during the late stage of mental rotation task. At the late stage of mental rotation, only the experimental group was found with differences in beta ERD related to varied degrees of the rotation angle and the control condition (zero angles, no rotation) recorded above the right parietal cortex and the central area of cerebral cortex. The present findings suggest that acoustic feedback might improve the process of mental rotation.",2019,"Compared to the controls, the experimental group was found with greater beta-band suppression recorded above the left parietal cortex during the early stage and above the right parietal cortex during the late stage of mental rotation task.","['consecutive stages of mental rotation of 3D objects', 'Thirty-three participants']","['acoustic neurofeedback', 'auditory stimuli', 'classic Shepard-Metzler mental rotation task']","['brain activity', 'level of concentration', 'beta ERD', 'beta-band suppression', 'Acoustic Neurofeedback Increases Beta ERD']","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}]","[{'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",33.0,0.0142498,"Compared to the controls, the experimental group was found with greater beta-band suppression recorded above the left parietal cortex during the early stage and above the right parietal cortex during the late stage of mental rotation task.","[{'ForeName': 'Wioletta Karina', 'Initials': 'WK', 'LastName': 'Ozga', 'Affiliation': 'Department of Experimental Psychology, Institute of Psychology, The John Paul II Catholic University of Lublin, Al. Racławickie 14, 20-950, Lublin, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Zapała', 'Affiliation': 'Department of Experimental Psychology, Institute of Psychology, The John Paul II Catholic University of Lublin, Al. Racławickie 14, 20-950, Lublin, Poland. dzapala@kul.pl.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Wierzgała', 'Affiliation': 'Department of Neuroinformatics, Institute of Computer Science, Maria Curie-Sklodowska University, Akademicka 9/509, 20-033, Lublin, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Augustynowicz', 'Affiliation': 'Department of Experimental Psychology, Institute of Psychology, The John Paul II Catholic University of Lublin, Al. Racławickie 14, 20-950, Lublin, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Porzak', 'Affiliation': 'Department of Psychology, Faculty of Human Sciences, University of Economics and Innovation in Lublin, Projektowa 4, 20-209, Lublin, Poland.'}, {'ForeName': 'Grzegorz Marcin', 'Initials': 'GM', 'LastName': 'Wójcik', 'Affiliation': 'Department of Neuroinformatics, Institute of Computer Science, Maria Curie-Sklodowska University, Akademicka 9/509, 20-033, Lublin, Poland.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-018-9426-0']
1405,31126694,"Tolerability and Pharmacokinetics of Contezolid at Therapeutic and Supratherapeutic Doses in Healthy Chinese Subjects, and Assessment of Contezolid Dosing Regimens Based on Pharmacokinetic/Pharmacodynamic Analysis.","PURPOSE


This study assessed the tolerability and pharmacokinetic (PK) properties of a new-generation oxazolidinone, contezolid (MRX-I), and its major inactive metabolite, M2, after single oral administrations of 800, 1200, and 1600 mg in the fed state, and compared the efficacy of 3 dosing regimens in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infection based on PK/pharmacodynamic (PD) analysis.
METHODS


A Phase I study at a single study center was conducted with 2 parts. In the first part, 20 healthy subjects received a single oral dose of 1200 or 1600 mg of contezolid or placebo in the fed state in a double-blind, placebo-controlled, dose-escalation tolerance study. In the second part of the study, 52 subjects received a single oral dose of 800 mg of contezolid in the fed state in a single-center, randomized, blinded, 4-period, crossover, thorough QT study. Noncompartmental analyses were used to evaluate the PK properties of contezolid and M2. Steady-state concentrations of contezolid following the 3 dosing regimens (800, 1200, and 1600 mg q12h) were simulated by employing a newly developed 2-compartmental PK model. The minimum inhibitory concentration (MIC) distributions of contezolid were analyzed in 178 Staphylococcus, Enterococcus, and Streptococcus clinical isolates. Monte Carlo simulations were conducted to predict the efficacy of the 3 dosing regimens to obtain probability of target attainment and cumulative fraction of response.
FINDINGS


Single-dose oral administrations of 800, 1200, and 1600 mg of contezolid were well tolerated in healthy subjects in the fed state, and nonlinear PK was observed. The mean plasma exposures to M2 exceeded 17.3% of contezolid exposure in the 3 groups. Both MIC 50  and MIC 90  (MICs that inhibit the growth of 50% and 90% of microorganisms, respectively) of contezolid against MRSA were 1 mg/L with clinical isolates from China. PK/PD analysis and Monte Carlo simulations predicted that 800 mg q12h of oral contezolid would be efficacious against MRSA infection, with a MIC of ≤4 mg/L (probability of target attainment, >90%; cumulative fraction of response, >90%).
IMPLICATIONS


Contezolid is a well-tolerated treatment option for MRSA infection, including at supratherapeutic doses up to 1600 mg. The regimen of 800 mg q12h could achieve efficacy in treating bacterial infection with MRSA. To our knowledge, this is the first PK study to predict that a dosing regimen of 800 mg q12h of oral contezolid is sufficient for treating MRSA infection, with a MIC of ≤4 mg/L. A Phase III study of this suggested dosing regimen is being conducted. Chinadrugtrials.org.cn identifier: CTR20161074.",2019,"Monte Carlo simulations were conducted to predict the efficacy of the 3 dosing regimens to obtain probability of target attainment and cumulative fraction of response.
","['20 healthy subjects', '52 subjects received a', 'Healthy Chinese Subjects', 'healthy subjects']","['single oral dose of 800\xa0mg of contezolid', 'contezolid or placebo']","['mean plasma exposures to M2', 'Tolerability and Pharmacokinetics', 'minimum inhibitory concentration (MIC) distributions of contezolid', 'tolerability and pharmacokinetic (PK) properties', 'PK properties of contezolid and M2']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]",20.0,0.0334892,"Monte Carlo simulations were conducted to predict the efficacy of the 3 dosing regimens to obtain probability of target attainment and cumulative fraction of response.
","[{'ForeName': 'Junzhen', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China; National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hailan', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China; National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China; National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yuancheng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China; Phase I Unit, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Beining', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China; National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Cao', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai, China; Phase I Unit, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai, China; Phase I Unit, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jicheng', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai, China; Phase I Unit, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jufang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai, China; Phase I Unit, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Demei', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; MicuRx Pharmaceuticals, Inc, Hayward, CA, USA.'}, {'ForeName': 'Fupin', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China; National Clinical Research Center for Aging and Medicine, Huashan Hospital, Fudan University, Shanghai, China; Phase I Unit, Huashan Hospital, Fudan University, Shanghai, China. Electronic address: zhangj_fudan@aliyun.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.04.025']
1406,30120894,Liver Complications Following Treatment of Hematologic Malignancy With Anti-CD22-Calicheamicin (Inotuzumab Ozogamicin).,"Treatment of hematological malignancy with antibody-drug conjugates (ADCs) may cause liver injury. ADCs deliver a toxic moiety into antigen-expressing tumor cells, but may also injure hepatic sinusoids (sinusoidal obstruction syndrome; SOS). We studied patients who received an anti-CD22/calicheamicin conjugate (inotuzumab ozogamicin; InO) to gain insight into mechanisms of sinusoidal injury, given that there are no CD22 +  cells in the normal liver, but nonspecific uptake of ADCs by liver sinusoidal endothelial cells (LSECs). Six hundred thirty-eight patients (307 with acute lymphocytic leukemia [ALL], 311 with non-Hodgkin's lymphoma [NHL]) were randomized to either InO or standard chemotherapy (controls). While blinded to treatment assignment, we reviewed all cases with hepatobiliary complications to adjudicate the causes. Frequency of SOS among patients who received InO was 5 of 328 (1.5%), compared to no cases among 310 control patients. Drug-induced liver injury (DILI) developed in 26 (7.9%) InO recipients and 3 (1%) controls. Intrahepatic cholestasis (IHC) was observed in 4.9% of InO recipients and in 5.5% of controls. Subsequent to the randomization study, 113 patients with ALL underwent allogeneic hematopoietic cell transplantation (HCT); frequency of SOS in those previously exposed to InO was 21 of 79 (27%) versus 3 of 34 (9%) in controls. An exploratory multivariate model identified a past history of liver disease and thrombocytopenia before conditioning therapy as dominant risk factors for SOS after transplant. Conclusion: Frequencies of SOS and DILI after inotuzumab ozogamicin treatment were 1.5% and 7.9%, respectively, compared to none and 1% among controls who received standard chemotherapy. These data suggest that ADCs that do not target antigens present in the normal liver have a relatively low frequency of SOS, but a relatively high frequency of DILI.",2019,"Frequency of SOS among patients who received InO was 5 of 328 (1.5%), compared to no cases among 310 control patients.","[""Six hundred thirty-eight patients (307 with acute lymphocytic leukemia [ALL], 311 with non-Hodgkin's lymphoma [NHL"", '113 patients with ALL underwent allogeneic hematopoietic cell transplantation (HCT']","['antibody-drug conjugates (ADCs', 'standard chemotherapy (controls', 'standard chemotherapy', 'anti-CD22/calicheamicin conjugate (inotuzumab ozogamicin', 'Anti-CD22-Calicheamicin (Inotuzumab Ozogamicin']","['Intrahepatic cholestasis (IHC', 'Drug-induced liver injury (DILI', 'Liver Complications', 'Frequency of SOS']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]","[{'cui': 'C4704928', 'cui_str': 'Antibody-Drug Conjugates'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C1567130', 'cui_str': 'inotuzumab ozogamicin'}]","[{'cui': 'C0008372', 'cui_str': 'Intrahepatic Cholestasis'}, {'cui': 'C0860207', 'cui_str': 'Drug-Induced Liver Injury'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",113.0,0.0241088,"Frequency of SOS among patients who received InO was 5 of 328 (1.5%), compared to no cases among 310 control patients.","[{'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'McDonald', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Freston', 'Affiliation': 'University of Connecticut Health Center, Farmington, CT.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Boyer', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'Laurie D', 'Initials': 'LD', 'LastName': 'DeLeve', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30222']
1407,31668885,"Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial.","OBJECTIVE


To evaluate neurodevelopment, growth, and health outcomes in infants receiving bovine milk fat globule membrane (MFGM) and lactoferrin in infant formula.
STUDY DESIGN


Healthy term infants were randomized to a cow's milk-based infant formula or MFGM + LF (a similar infant formula, with an added source of bovine milk fat globule membrane [bMFGM; whey protein-lipid concentrate, 5 g/L] and bovine lactoferrin [0.6 g/L]) through 365 days of age. The Bayley Scales of Infant Development, 3rd edition cognitive composite score at day 365 was the primary outcome. Secondary outcomes included tolerance measures through day 365, additional neurodevelopmental and language outcomes, growth, and medically confirmed adverse events through day 545.
RESULTS


Of 451 infants enrolled (control, 228; MFGM + LF, 223), 291 completed study feeding and Bayley-III testing at day 365 (control, 148; MFGM + LF, 143). The mean cognitive (+8.7), language (+12.3), and motor (+12.6) scores were higher (P < .001) for the MFGM + LF group; no differences were observed at day 545. Global development scores from day 120 to day 275 and attention at day 365 were significantly improved. Few group differences in day 545 neurodevelopmental outcomes were detected, however scores of some subcategories of the MacArthur-Bates Communicative Development Inventories were higher (P < .05) in the MFGM + LF group. The overall incidence of respiratory-associated adverse events and diarrhea were significantly lower for the MFGM + LF group through day 545.
CONCLUSIONS


Infants receiving formula with added bovine MFGM and bovine lactoferrin had an accelerated neurodevelopmental profile at day 365 and improved language subcategories at day 545. Formulas were associated with age-appropriate growth and significantly fewer diarrhea and respiratory-associated adverse events through 545 days of age. TRIAL REGISTRATION CLINICALTRIALS.GOV:: NCT02274883.",2019,"Few group differences in day 545 neurodevelopmental outcomes were detected, however scores of some subcategories of the MacArthur-Bates Communicative Development Inventories were higher (P < .05) in the MFGM + LF group.","['451 infants enrolled (control, 228; MFGM\xa0+\xa0LF, 223), 291 completed study feeding and Bayley-III testing at day 365 (control, 148; MFGM\xa0+\xa0LF, 143', 'infants receiving bovine milk fat globule membrane (MFGM) and lactoferrin in infant formula', 'Healthy term infants']","['Bovine Milk Fat Globule Membrane and Lactoferrin', 'formula with added bovine MFGM and bovine lactoferrin', 'MFGM\xa0', ""cow's milk-based infant formula or MFGM\xa0+\xa0LF (a similar infant formula, with an added source of bovine milk fat globule membrane [bMFGM; whey protein-lipid concentrate, 5\xa0g/L] and bovine lactoferrin""]","['accelerated neurodevelopmental profile', 'Global development scores', 'overall incidence of respiratory-associated adverse events and diarrhea', 'Bayley Scales of Infant Development, 3rd edition cognitive composite score', 'language subcategories', 'mean cognitive', 'diarrhea and respiratory-associated adverse events', 'scores of some subcategories of the MacArthur-Bates Communicative Development Inventories', 'tolerance measures through day 365, additional neurodevelopmental and language outcomes, growth, and medically confirmed adverse events']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0670751', 'cui_str': 'milk fat globule'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]","[{'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0670751', 'cui_str': 'milk fat globule'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1440867', 'cui_str': 'lactoferrin, bovine'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk (substance)""}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}]",545.0,0.210636,"Few group differences in day 545 neurodevelopmental outcomes were detected, however scores of some subcategories of the MacArthur-Bates Communicative Development Inventories were higher (P < .05) in the MFGM + LF group.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Departments of Developmental and Behavioral Pediatrics & Child Primary Care, MOE-Shanghai Key Lab for Children's Environmental Health, Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Wu', 'Affiliation': 'Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN. Electronic address: Steven.Wu2@rb.com.'}, {'ForeName': 'Carol Lynn', 'Initials': 'CL', 'LastName': 'Berseth', 'Affiliation': 'Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN; Medical and Scientific Affairs, Brightseed, San Francisco, California.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Harris', 'Affiliation': 'Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Richards', 'Affiliation': 'Nutrition Science, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN; DSM Nutritional Products, Parsippany, New Jersey.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Wampler', 'Affiliation': 'Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Zhuang', 'Affiliation': 'Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Cleghorn', 'Affiliation': 'Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN; Faculty of Health, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Colin D', 'Initials': 'CD', 'LastName': 'Rudolph', 'Affiliation': 'Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN; Department of Pediatrics, University of California, San Francisco, CA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN; College of Biotechnology, East China University of Science and Technology, Shanghai, China.'}, {'ForeName': 'D Jill', 'Initials': 'DJ', 'LastName': 'Shaddy', 'Affiliation': 'Schiefelbusch Institute for Life Span Studies, University of Kansas, Lawrence, KS.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Colombo', 'Affiliation': 'Schiefelbusch Institute for Life Span Studies, University of Kansas, Lawrence, KS.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.08.030']
1408,31634305,Differences Between Mothers' and Fathers' Perception of Their Adolescents' Pain Before and After Parent Training Through The Comfort Ability Pain Management Program.,"OBJECTIVE


To evaluate differences in how mothers and fathers perceive and respond to their adolescents' chronic pain before and after The Comfort Ability Program (CAP), a 1-day cognitive-behavioral intervention, and to compare outcomes between mother-father dyads and mothers who attended the intervention alone.
METHODS


Parents completed the Pain Catastrophizing Scale (PCS) and Helping for Health Inventory (HHI) at baseline (preintervention) and at 1 week, 1 month, and 3 months after intervention. Confirmatory factor analyses evaluated construct validity and invariances of the scales. Paired t tests compared scores between mothers and fathers. Unpaired t tests compared mother-father dyads (n = 33) and mothers who attended the intervention alone (n = 73).
RESULTS


PCS baseline showed significant construct instability between maternal and paternal interpretations. However, 1 week after intervention, construct stability improved between parents. On the PCS and HHI, in which lower scores represent more adaptive parenting behaviors, fathers scored significantly lower than mothers at baseline (PCS: 22.6 [7.7] vs 28.0 [11.4], p value = 0.033; HHI: 16.0 [8.1] vs 20.6 [9.6], p value = 0.029). At 3 months after intervention, PCS scores for both mothers and fathers significantly decreased from baseline (mothers: p value = 0.009; fathers: p value = 0.052) and converged (mothers: 18.6 [11.2] vs fathers: 18.3 [13.2]; p value = 0.786). Mother and father HHI scores were significantly lower at 3 months than baseline (mothers: 13.2 [9.5], p value = 0.005; fathers: 15.0 [12.7], p value = 0.017), although improvement of construct stability between parents was less evident.
CONCLUSION


Findings suggest that mothers and fathers may differentially perceive and respond to their adolescents' pain and that CAP parent-training intervention may help align their thinking. The results further demonstrate that both parents make adaptive changes after intervention, reinforcing the value of including both parents in pediatric treatment for chronic pain.",2019,"On the PCS and HHI, in which lower scores represent more adaptive parenting behaviors, fathers scored significantly lower than mothers at baseline (PCS: 22.6 [7.7] vs 28.0 [11.4], p value = 0.033; HHI: 16.0 [8.1] vs 20.6 [9.6], p value = 0.029).",['mother-father dyads and mothers who attended the intervention alone'],"['Comfort Ability Program (CAP), a 1-day cognitive-behavioral intervention']","['adaptive parenting behaviors', 'Pain Catastrophizing Scale (PCS) and Helping for Health Inventory (HHI', 'construct stability', 'Mother and father HHI scores', 'PCS scores']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.03082,"On the PCS and HHI, in which lower scores represent more adaptive parenting behaviors, fathers scored significantly lower than mothers at baseline (PCS: 22.6 [7.7] vs 28.0 [11.4], p value = 0.033; HHI: 16.0 [8.1] vs 20.6 [9.6], p value = 0.029).","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Donado', 'Affiliation': ""Department of Anesthesia, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Turrisi', 'Affiliation': ""Department of Anesthesia, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Wihak', 'Affiliation': ""Department of Anesthesia, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Rachael B', 'Initials': 'RB', 'LastName': 'Coakley', 'Affiliation': ""Department of Anesthesia, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000738']
1409,31393319,Impact of Stressful Climates on Provider Perceptions of Integrated Behavioral Health Services in Pediatric Primary Care: An Exploratory Study.,"OBJECTIVE


Pediatric primary care providers (PCPs) work in challenging environments and are increasingly called to implement complex interventions, such as behavioral health (BH) service integration. We explore how perceived stressful practice climates (1) change over time in and (2) influence provider perceptions of collaborative care versus usual care, 2 models of integrated BH care.
METHODS


Secondary exploratory analysis using hierarchical linear modeling was performed on an 18-month cluster-randomized trial of 8 pediatric primary care practices to Doctor-Office Collaborative Care (DOCC), where an on-site care manager delivered BH services in coordination with PCPs, or Enhanced Usual Care (EUC), where a care manager facilitated referrals to local BH providers. Various indicators of PCP perceptions of BH services, including satisfaction with practice, burdens and beliefs regarding psychosocial problems, and effectiveness in treating behavioral problems, were assessed as outcomes. Moderators were 2 domains of stressful climates, role conflict and role overload.
RESULTS


Role conflict and role overload stayed stable in both conditions. Role conflict strengthened the positive effect of DOCC on PCP perceived effectiveness in treating behavioral problems (β [SE], 0.04 [0.02]; p = 0.04) and improvement in managing oppositional/aggressive behavior (0.02 [0.01]; p = 0.02). Role overload strengthened the positive effect of DOCC on PCP-perceived improvement in managing attention-deficit hyperactivity disorder (0.03 [0.01]; p = 0.01). Stressful climates did not influence perceptions for EUC providers.
CONCLUSIONS


Providers experiencing more stressful practice climates developed more positive perceptions of collaborative care. This may encourage stressed providers to make effective practice changes and promote practice integration of BH services.",2019,Role overload strengthened the positive effect of DOCC on PCP-perceived improvement in managing attention-deficit hyperactivity disorder (0.03 [0.01]; p = 0.01).,"['Pediatric Primary Care', '8 pediatric primary care practices to Doctor-Office Collaborative Care (DOCC), where an on-site care manager delivered BH services in coordination with PCPs, or Enhanced Usual Care (EUC), where a care manager facilitated referrals to local BH providers']",['Stressful Climates'],"['stressful climates, role conflict and role overload', 'managing attention-deficit hyperactivity disorder', 'satisfaction with practice, burdens and beliefs regarding psychosocial problems, and effectiveness in treating behavioral problems', 'managing oppositional/aggressive behavior']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0031834', 'cui_str': ""Physicians' Offices""}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0687694', 'cui_str': 'Case Manager'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]","[{'cui': 'C0008946', 'cui_str': 'Climate'}]","[{'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}]",,0.0462052,Role overload strengthened the positive effect of DOCC on PCP-perceived improvement in managing attention-deficit hyperactivity disorder (0.03 [0.01]; p = 0.01).,"[{'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Hsiung', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hart', 'Affiliation': 'Western Psychiatric Hospital, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Kelleher', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, Columbus, OH.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kolko', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000712']
1410,31172394,"Effect of Moola Bandha (Perineum Contraction), A Yogic Lock on Cognitive Functions of College Students: An Exploratory Study.","Academic performance and excellence of college students are mainly depending on their cognitive functions. The purpose of this study was to examine the effectiveness of a yogic lock or hold, Moola bandha (perineum contraction) on cognitive functions of teacher training college students. Twenty-three healthy volunteers with the mean ± standard deviation age of 21.96 ± 1.64 years were recruited from a district institute of education and training (DIET) college, North India. All the subjects were asked to perform Moola bandha for the duration of 30 min a day (15 min in the morning and 15 min in the evening) for a period of 30 days. Assessments were taken before and after the intervention period. Results of this study showed a significant increase in the scores of d2 attention total number, digits span forward and backward test, Stroop tasks (neutral total and correct, congruent total and correct, and incongruent correct), and self-control scale along with a significant reduction in d2 attention (omission, commission, and timings), trail making text A and B duration, and positive and negative affective schedule's negative affect scores compared with its respective baseline. These results suggest that 30 min of daily practice of Moola bandha for 30 days is effective in improving the cognitive functions of teacher training college students.",2020,"Results of this study showed a significant increase in the scores of d2 attention total number, digits span forward and backward test, Stroop tasks (neutral total and correct, congruent total and correct, and incongruent correct), and self-control scale along with a significant reduction in d2 attention (omission, commission, and timings), trail making text A and B duration, and positive and negative affective schedule's negative affect scores compared with its respective baseline.","['College Students', 'college students', 'Twenty-three healthy volunteers with the mean\u2009±\u2009standard deviation age of 21.96\u2009±', 'teacher training college students', '1.64\xa0years were recruited from a district institute of education and training (DIET) college, North India']","['yogic lock or hold, Moola bandha (perineum contraction', 'Moola Bandha (Perineum Contraction']","['cognitive functions', ""d2 attention (omission, commission, and timings), trail making text A and B duration, and positive and negative affective schedule's negative affect scores"", 'scores of d2 attention total number, digits span forward and backward test, Stroop tasks (neutral total and correct, congruent total and correct, and incongruent correct), and self-control scale']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4082803', 'cui_str': 'Teacher Training'}, {'cui': 'C4517509', 'cui_str': '1.64 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C1553387', 'cui_str': 'Hold'}, {'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0439853', 'cui_str': 'Congruent (qualifier value)'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0222045'}]",23.0,0.0166047,"Results of this study showed a significant increase in the scores of d2 attention total number, digits span forward and backward test, Stroop tasks (neutral total and correct, congruent total and correct, and incongruent correct), and self-control scale along with a significant reduction in d2 attention (omission, commission, and timings), trail making text A and B duration, and positive and negative affective schedule's negative affect scores compared with its respective baseline.","[{'ForeName': 'Sakshi', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Yoga Therapy, S-VYASA Deemed to be University, Bengaluru, Karnataka, India.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Nivethitha', 'Affiliation': 'Department of Naturopathy, Government Yoga and Naturopathy Medical College, Arumbakkam, Chennai, 600106, Tamilnadu, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mooventhan', 'Affiliation': 'Department of Naturopathy, Government Yoga and Naturopathy Medical College, Arumbakkam, Chennai, 600106, Tamilnadu, India. dr.mooventhan@gmail.com.'}]",Journal of religion and health,['10.1007/s10943-019-00856-0']
1411,31648850,"Dietary instructions focusing on meal-sequence and nutritional balance for prediabetes subjects: An exploratory, cluster-randomized, prospective, open-label, clinical trial.","BACKGROUND


Although lifestyle modifications are known to be effective in type 2 diabetes (T2D) as well as in prediabetes, adherence to a healthy diet is difficult for some, and interventions of lifestyle modifications need to be revised occasionally. Meal sequence has been gaining attention as a part of a healthy diet among T2D individuals to improve glycemia and body weight. In addition, a dietary instruction program, SMART Washoku®, which can help individuals to consume a more nutritionally balanced diet, has been developed.
METHODS


The current exploratory trial was designed to examine the effects of dietary instructions focusing on meal sequence and nutritional balance in individuals with prediabetes in the Japanese national health check-up and guidance program. Participants were cluster-randomized into three groups: Group A, receiving a conventional health guidance program (n = 11); Group B, receiving health guidance with dietary instructions focusing on meal sequence (n = 18); and Group C, receiving health guidance with dietary instructions focusing on nutritional balance (n = 13). Participants received health guidance education and various measurements before and 6 months after the instructions.
RESULTS


Body weight in Group B was significantly reduced compared to that in Group A, with similar adherence, while the effects on glycemia were similar between the two Groups. Body weight reduction was greater in Group C compared to that in Group A, although adherence in Group C was significantly lower than that in Group A.
CONCLUSION


The group receiving health guidance with dietary instructions focusing on meal sequence exhibited similar adherence and greater reduction in body weight than the group receiving conventional health guidance.",2019,"Body weight reduction was greater in Group C compared to that in Group A, although adherence in Group C was significantly lower than that in Group A.
CONCLUSION


","['individuals with prediabetes in the Japanese national health check-up and guidance program', 'prediabetes subjects']","['Dietary instructions focusing on meal-sequence and nutritional balance', 'conventional health guidance program (n\u202f=\u202f11); Group B, receiving health guidance with dietary instructions focusing on meal sequence (n\u202f=\u202f18); and Group C, receiving health guidance with dietary instructions focusing on nutritional balance', 'health guidance with dietary instructions focusing on meal sequence exhibited similar adherence and greater reduction in body weight than the group receiving conventional health guidance', 'dietary instructions', 'health guidance education']","['Body weight', 'glycemia', 'Body weight reduction']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0165764,"Body weight reduction was greater in Group C compared to that in Group A, although adherence in Group C was significantly lower than that in Group A.
CONCLUSION


","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yabe', 'Affiliation': 'Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan; Department of Diabetes and Endocrinology, Gifu University Graduate School of Medicine, Gifu, Japan; Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan; Division of Molecular and Metabolic Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. Electronic address: ydaisuke-kyoto@umin.ac.jp.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kuwata', 'Affiliation': 'Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan; Center for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan; Center for Metabolism and Clinical Nutrition, Kansai Electric Power Hospital, Osaka, Japan.'}, {'ForeName': 'Yuuka', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan.'}, {'ForeName': 'Mayuka', 'Initials': 'M', 'LastName': 'Sakaguchi', 'Affiliation': 'Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan; Center for Metabolism and Clinical Nutrition, Kansai Electric Power Hospital, Osaka, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Moyama', 'Affiliation': 'Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan; Center for Metabolism and Clinical Nutrition, Kansai Electric Power Hospital, Osaka, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Makabe', 'Affiliation': 'Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan; Center for Metabolism and Clinical Nutrition, Kansai Electric Power Hospital, Osaka, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Murotani', 'Affiliation': 'Biostatistics Center, Graduate School of Medicine, Kurume University, Fukuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Asano', 'Affiliation': 'Kansaimedicalnet Co., Ltd., Kyoto, Japan.'}, {'ForeName': 'Sanae', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Kansaimedicalnet Co., Ltd., Kyoto, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Mishima', 'Affiliation': 'Kansai Electric Power Company, Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Takase', 'Affiliation': 'Kao Corporation, Tokyo, Japan.'}, {'ForeName': 'Noriyasu', 'Initials': 'N', 'LastName': 'Ota', 'Affiliation': 'Kao Corporation, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Seino', 'Affiliation': 'Department of Endocrinology and Metabolism, Fujita Health University School of Medicine, Toyoake, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan; Center for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kurose', 'Affiliation': 'Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan; Nakanoshima clinic, Osaka, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Seino', 'Affiliation': 'Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan; Center for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan. Electronic address: yutaka.seino@kepmri.org.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.107450']
1412,31101534,"Docetaxel plus cisplatin and S-1 versus cisplatin and S-1 in patients with advanced gastric cancer (JCOG1013): an open-label, phase 3, randomised controlled trial.","BACKGROUND


We investigated the superiority of docetaxel plus cisplatin and S-1 compared with cisplatin and S-1 in chemotherapy-naive patients with advanced gastric cancer.
METHODS


In this open-label, phase 3, randomised controlled trial, patients were recruited from 56 hospitals in Japan. We enrolled individuals aged 20-75 years who had unresectable or recurrent gastric cancer, had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, had received no previous chemotherapy (except adjuvant chemotherapy completed 24 weeks before reccurence), radiotherapy, or hormonal therapy, could take drugs orally, and had adequate organ function. Patients were randomly assigned (1:1) to receive docetaxel plus cisplatin and S-1 (docetaxel 40 mg/m 2  and cisplatin 60 mg/m 2  on day 1 intravenously, and S-1 40-60 mg twice a day orally for 2 weeks, every 4 weeks) or cisplatin and S-1 (cisplatin 60 mg/m 2  intravenously on day 8, and S-1 40-60 mg orally twice a day for 3 weeks, every 5 weeks). Randomisation was done centrally with the minimisation method, with a random component balancing for institution, ECOG performance status (0 vs 1), disease status at enrolment (unresectable vs recurrent), measurable lesion (yes vs no), number of metastatic sites (0-1 vs ≥2), and histological type (differentiated vs undifferentiated). Neither investigators or patients were masked to the study treatment. The primary endpoint was overall survival in the intention-to-treat population. The study is registered with UMIN-CTR, number UMIN000007652.
FINDINGS


Between April 3, 2012, and March 18, 2016, 741 patients were randomly assigned to receive docetaxel plus cisplatin and S-1 (n=370) or cisplatin and S-1 (n=371). Median overall survival was 14·2 months (95% CI 12·9-15·9) in the docetaxel plus cisplatin and S-1 group and 15·3 months (14·2-16·2) in the cisplatin and S-1 group (hazard ratio [HR] 0·99 [95% CI 0·85-1·16]; one-sided stratified log-rank p=0·47). The most common grade 3 or worse adverse events were neutropenia (209 [59%] of 357 patients in the docetaxel plus cisplatin and S-1 group vs 117 [32%] of 365 patients in the cisplatin and S-1 group), leukopenia (120 [34%] vs 60 [16%]), and anorexia (94 [26%] vs 81 [22%]). The deaths of one patient in the cisplatin and S-1 group and in three patients in the docetaxel plus cisplatin and S-1 group were deemed treatment-related.
INTERPRETATION


The addition of docetaxel to cisplatin and S-1 did not improve overall survival in chemotherapy-naive Japanese patients with advanced gastric cancer. Therefore, cisplatin and S-1 remains the standard first-line chemotherapy.
FUNDING


Ministry of Health, Labour and Welfare and Japan Agency for Medical Research and Development.",2019,Median overall survival was 14·2 months (95% CI 12·9-15·9) in the docetaxel plus cisplatin and S-1 group and 15·3 months (14·2-16·2) in the cisplatin and S-1 group (hazard ratio [HR] 0·99,"['patients were recruited from 56 hospitals in Japan', 'Between April 3, 2012, and March 18, 2016', 'chemotherapy-naive Japanese patients with advanced gastric cancer', 'patients with advanced gastric cancer (JCOG1013', 'enrolled individuals aged 20-75 years who had unresectable or recurrent gastric cancer, had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, had received no previous chemotherapy (except adjuvant chemotherapy completed 24 weeks before reccurence', 'chemotherapy-naive patients with advanced gastric cancer', '741 patients']","['cisplatin', 'docetaxel plus cisplatin and S-1 (docetaxel 40 mg/m 2  and cisplatin', 'cisplatin and S-1', 'cisplatin and S-1 ', 'docetaxel plus cisplatin and S-1 (n=370) or cisplatin and', 'Docetaxel plus cisplatin and S-1 versus cisplatin and S-1', 'docetaxel plus cisplatin', 'docetaxel to cisplatin and S-1', 'radiotherapy, or hormonal therapy', 'docetaxel plus cisplatin and S-1']","['number of metastatic sites', 'leukopenia', 'neutropenia', 'anorexia', 'Median overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",741.0,0.21854,Median overall survival was 14·2 months (95% CI 12·9-15·9) in the docetaxel plus cisplatin and S-1 group and 15·3 months (14·2-16·2) in the cisplatin and S-1 group (hazard ratio [HR] 0·99,"[{'ForeName': 'Yasuhide', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Comprehensive Cancer Center, National Center for Global Health and Medicine, Shinjuku-ku, Tokyo, Japan; Department of Medical Oncology, Hamamatsu University School of Medicine, Shizuoka, Japan; Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan. Electronic address: yayamada@hosp.ncgm.go.jp.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'Japan Clinical Oncology Group Data Center and Operations Office, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwasa', 'Affiliation': 'Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Chikusa-ku, Nagoya, Aichi, Japan.'}, {'ForeName': 'Norisuke', 'Initials': 'N', 'LastName': 'Nakayama', 'Affiliation': 'Department of Gastroenterology, Kanagawa Cancer Center Hospital, Asahi-ku, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Mizutomo', 'Initials': 'M', 'LastName': 'Azuma', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, Minami, Sagamihara, Kanagawa, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Gastroenterology, Hyogo Cancer Center, Akashi, Hyogo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, Kindai University, Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': 'Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Hata', 'Affiliation': 'Department of Surgery, National Hospital Organization Kyoto Medical Center, Fushimi-ku, Kyoto, Japan.'}, {'ForeName': 'Mikihito', 'Initials': 'M', 'LastName': 'Nakamori', 'Affiliation': 'Second Department of Surgery, School of Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Inamachi, Kitaadachi-gun, Saitama, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Yasui', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'Japan Clinical Oncology Group Data Center and Operations Office, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'Japan Clinical Oncology Group Data Center and Operations Office, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center Hospital, Asahi-ku, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Sasako', 'Affiliation': 'Department of Surgery, Hyogo College of Medicine, Fushimi-ku Mukogawa-cho, Nishinomiya-shi, Hyogo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Division of Gastric Surgery, Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30083-4']
1413,32410608,The role of text messaging intervention in Inner Mongolia among patients with type 2 diabetes mellitus: a randomized controlled trial.,"BACKGROUND


Short messages service (SMS) provides a practical medium for delivering content to address patients to adherence to self-management. The aim of study was to design some patient-centered health education messages, evaluate the feasibility of messages, and explore the effect of this model.
METHODS


The messages were designed by a panel of experts, and SMS Quality Evaluation Questionnaire was used to evaluate their quality. A two-arm randomized controlled trial was conducted to evaluate the effectiveness of this management model. Participants were randomly divided into an intervention group (IG) who received evaluated messages and a control group (CG) who received regular education. The primary outcomes were changes in plasma glucose and control rates, and the secondary outcomes were improvements in diet control, physical activities, weight control, etc. RESULTS: A total of 42 messages covering five main domains: health awareness, diet control, physical activities, living habits and weight control were designed, and the average scores of the messages were 8.0 (SD 0.7), 8.5 (SD 0.6), 7.9 (SD 1.0), 8.0 (SD 0.7), and 8.4 (SD 0.9), respectively. In the SMS intervention, 171 patients with an average age of 55.1 years were involved, including 86 in the CG and 85 in the IG. At 12 months, compared with the control group (CG), the decrease of fasting plasma glucose (FPG) (1.5 vs. 0.4, P = 0.011) and control rate (49.4% vs. 33.3%, P = 0.034), the postprandial glucose (PPG) (5.8 vs. 4.2, P = 0.009) and control rate (57.8% vs. 33.7%, P = 0.002) were better in the intervention group (IG). In terms of self-management, improvements in weight control (49.3% vs. 28.2%, P = 0.031), vegetables consumption (87.3% vs. 29.0%, P < 0.001), fruits consumption (27.5% vs. 7.4%, P = 0.022), and physical activities (84.7% vs. 70.0%, P = 0.036) were better in the IG than in the CG.
CONCLUSIONS


The overall quality of the messages was high. It was effective and feasible to carry out an SMS intervention to improve the behavioral habits of patients with chronic diseases in remote and undeveloped areas.
TRIAL REGISTRATION


Clinicaltrials.gov, ChiCTR1900023445. Registered May 28, 2019--Retrospectively registered.",2020,"It was effective and feasible to carry out an SMS intervention to improve the behavioral habits of patients with chronic diseases in remote and undeveloped areas.
","['patients with type 2 diabetes mellitus', '171 patients with an average age of 55.1\u2009years were involved, including 86 in the CG and 85 in the IG', 'patients with chronic diseases in remote and undeveloped areas']","['intervention group (IG) who received evaluated messages and a control group (CG) who received regular education', 'Short messages service (SMS', 'SMS intervention', 'text messaging intervention']","['fruits consumption', 'fasting plasma glucose (FPG', 'weight control', 'physical activities', 'overall quality', 'diet control, physical activities, weight control, etc', 'postprandial glucose (PPG', 'vegetables consumption', 'behavioral habits', 'control rate', 'changes in plasma glucose and control rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",171.0,0.0897911,"It was effective and feasible to carry out an SMS intervention to improve the behavioral habits of patients with chronic diseases in remote and undeveloped areas.
","[{'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Health Statistics, School of Public Health, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Health Statistics, School of Public Health, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Maolin', 'Initials': 'M', 'LastName': 'Du', 'Affiliation': 'Department of Health Statistics, School of Public Health, Inner Mongolia Medical University, Hohhot, China. dumaolin2016@163.com.'}, {'ForeName': 'Ruiqi', 'Initials': 'R', 'LastName': 'Hao', 'Affiliation': 'Department of Health Statistics, School of Public Health, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Huiqiu', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Health Statistics, School of Public Health, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Chaoli', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-01129-7']
1414,31164429,The role of CPAP treatment in elderly patients with moderate obstructive sleep apnoea: a multicentre randomised controlled trial.,"The efficacy of continuous positive airway pressure (CPAP) treatment in elderly patients with nonsevere obstructive sleep apnoea (OSA) is controversial. The objective of this study was to assess the effect of CPAP treatment in elderly patients with moderate OSA in terms of clinical, quality-of-life and neurocognitive measures.This was an open-label, randomised, multicentre clinical trial in 145 elderly patients (≥70 years old) with confirmed moderate OSA (apnoea-hypopnoea index 15-29.9 events·h -1 ) randomised to receive CPAP (n=73) or no CPAP (n=72) for 3 months. The primary end-point was the Epworth Sleepiness Scale (ESS) score, and the secondary end-points included quality of life (Quebec Sleep Questionnaire (QSQ) domain scores), sleep-related symptoms, presence of anxiety/depression, office-based blood pressure measurements and some neurocognitive tests. The analysis was performed according to the intention-to-treat principle.Mean±sd age was 74.9±4.6 years. The CPAP group achieved a greater improvement in the ESS score (adjusted difference of 2.6 (95% CI 3.6-1.6) points; effect size 1) in some sleep-related symptoms and in some dimensions of the QSQ questionnaire (nocturnal symptoms: -0.7 (95% CI -0.3--1.0) points; p<0.0001 and emotions: -0.4 (95% CI -0.1--0.7) points; p=0.023). However, CPAP did not demonstrate any effect on either neurocognitive tests (including anxiety and depression) or blood pressure levels. There was a positive correlation between the effect of CPAP and the improvement in ESS scores and quality of life domains.CPAP treatment resulted in a significant improvement in diurnal hypersomnia and some sleep-related symptoms and quality of life domains in elderly patients with moderate OSA.",2019,There was a positive correlation between the effect of CPAP and the improvement in EES values and quality of life domains.,"['elderly patients with non-severe obstructive sleep apnea (OSA', '143 elderly (≥70\u2005years old) patients with confirmed moderate OSA (apnea-hypopnea index between 15 and 29.9\u2005events·h -1 ) randomised to receive', 'elderly patients with moderate obstructive sleep apnea', 'Mean (sd) age was 74.9 (4.6) years', 'elderly patients with moderate OSA']","['continuous positive airway pressure (CPAP', 'CPAP', 'CPAP (n=73) or no CPAP']","['Epworth Sleepiness Scale (ESS) value, and the secondary endpoints included quality of life (Quebec Sleep Questionnaire [QSQ]), sleep-related symptoms, presence of anxiety/depression, office-based blood pressure measurements and some neurocognitive tests', 'QSQ questionnaire', 'EES values and quality of life domains', 'EES value', 'neurocognitive tests (including anxiety and depression) or the blood pressure levels', 'diurnal hypersomnia and some sleep-related symptoms and quality of life domains']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0872227', 'cui_str': 'Neurocognitive Tests'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}]",143.0,0.149318,There was a positive correlation between the effect of CPAP and the improvement in EES values and quality of life domains.,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ponce', 'Affiliation': 'Pneumology Dept, Hospital Universitario Dr Peset, Valencia, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Pastor', 'Affiliation': 'Pneumology Dept, Hospital Universitario San Juan, Alicante, Spain.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Orosa', 'Affiliation': 'Pneumology Dept, Hospital Universitario Dr Peset, Valencia, Spain.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Oscullo', 'Affiliation': 'Pneumology Dept, Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Catalán', 'Affiliation': 'Internal Medicine Dept, Hospital General de Requena, Valencia, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': 'Pneumology Dept, Hospital General Universitario de Castellón, Valencia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Hernández', 'Affiliation': 'Pneumology Dept, Hospital General Universitario de Alicante, Valencia, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Muriel', 'Affiliation': 'Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, IRYCIS, CIBERESP, Nursing Dept, Alcala University, Madrid, Spain.'}, {'ForeName': 'Eusebi', 'Initials': 'E', 'LastName': 'Chiner', 'Affiliation': 'Pneumology Dept, Hospital Universitario San Juan, Alicante, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martínez-García', 'Affiliation': 'Pneumology Dept, Hospital Universitario y Politécnico La Fe, Valencia, Spain mianmartinezgarcia@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.00518-2019']
1415,31374188,"Medroxyprogesterone acetate concentrations among HIV-infected depot-medroxyprogesterone acetate users receiving antiretroviral therapy in Lilongwe, Malawi.","OBJECTIVE


To compare medroxyprogesterone acetate (MPA) concentrations between HIV-positive women on antiretroviral therapy (ART) and HIV-negative women initiating depot medroxyprogesterone (DMPA) injectable.
STUDY DESIGN


Secondary analysis of 28 HIV-positive women on non-nucleoside reverse transcriptase inhibitor-containing ART regimens and 10 HIV-negative women randomized to initiate DMPA in a clinical trial of progestin contraception in Malawi.
RESULTS


MPA concentrations were significantly lower among HIV-positive women on ART, compared with HIV-negative women, at week 4 and week 13 (p=.03 for both), but not at day 3 or week 26 post-DMPA initiation.
CONCLUSIONS


Antiretroviral medications may affect MPA metabolism in HIV-positive African women.",2019,"RESULTS


MPA concentrations were significantly lower among HIV-positive women on ART, compared with HIV-negative women, at week 4 and week 13 (p=.03 for both), but not at day 3 or week 26 post-DMPA initiation.
","['28 HIV-positive women on non-nucleoside reverse transcriptase inhibitor-containing ART regimens and 10 HIV-negative women', 'HIV-positive African women', 'HIV-positive women on antiretroviral therapy (ART) and HIV-negative women initiating depot', 'HIV-infected depot-medroxyprogesterone acetate users receiving antiretroviral therapy in Lilongwe, Malawi']","['medroxyprogesterone (DMPA', 'DMPA', 'progestin contraception', 'medroxyprogesterone acetate (MPA', 'Medroxyprogesterone acetate']","['MPA concentrations', 'MPA metabolism']","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3541376', 'cui_str': 'Non-nucleoside reverse transcriptase inhibitors'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}]","[{'cui': 'C0025147', 'cui_str': 'Medroxyprogesterone'}, {'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-para-anisidine'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",28.0,0.386095,"RESULTS


MPA concentrations were significantly lower among HIV-positive women on ART, compared with HIV-negative women, at week 4 and week 13 (p=.03 for both), but not at day 3 or week 26 post-DMPA initiation.
","[{'ForeName': 'Yasaman', 'Initials': 'Y', 'LastName': 'Zia', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Reproductive Health, Atlanta, GA; Association of Schools and Programs of Public Health, Washington, DC. Electronic address: yaszia@gmail.com.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina- Chapel Hill, School of Medicine, Chapel Hill, NC; UNC Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Lameck', 'Initials': 'L', 'LastName': 'Chinula', 'Affiliation': 'UNC Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Tegha', 'Affiliation': 'UNC Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Frank Z', 'Initials': 'FZ', 'LastName': 'Stanczyk', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Athena P', 'Initials': 'AP', 'LastName': 'Kourtis', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Reproductive Health, Atlanta, GA.'}]",Contraception,['10.1016/j.contraception.2019.07.144']
1416,31075442,Grapefruit juice prolongs the QT interval of healthy volunteers and patients with long QT syndrome.,"BACKGROUND


The list of medications linked to drug-induced long QT syndrome (LQTS) is diverse. It is possible that food products too have QT-prolonging potential.
OBJECTIVE


We tested the effects of grapefruit juice on the QT interval with the methodology used by the pharmaceutical industry to test new drugs.
METHODS


This was an open-label, randomized, crossover study with blinded outcome evaluation, a thorough QT study of grapefruit juice performed according to the Guidelines for the Clinical Evaluation of QT/QTc for Non-antiarrhythmic Drugs. Thirty healthy volunteers and 10 patients with congenital LQTS were studied. Healthy volunteers drank 2 L of grapefruit juice (in divided doses), or received 400 mg oral moxifloxacin, in a randomized crossover study. Patients with LQTS were tested with only grapefruit. Repeated baseline, off-drug, and on-drug (grapefruit or moxifloxacin) electrocardiograms were scanned and coded. QT measurements were done with electronic calipers.
RESULTS


In comparison to off-drug electrocardiograms, grapefruit juice led to significant rate-corrected QT (QTc) prolongation. The absolute net QTc prolongation from grapefruit was 14.0 ms (95% confidence interval 6.2-21.7 ms; P < .001). The QT-prolonging effects of grapefruit in healthy volunteers were comparable with those of moxifloxacin. The QT-prolonging effects of grapefruit juice were greater in female patients and particularly marked in patients with LQTS (net QTc prolongation 21.8 ms; 95% confidence interval 3.4-35.3 ms; P = .034).
CONCLUSION


Grapefruit juice, at doses tested, prolongs the QT interval. The effect is significant in healthy volunteers, greater in female patients, and more so in patients with LQTS.",2019,The QT-prolonging effects of grapefruit in healthy volunteers were comparable with those of moxifloxacin.,"['healthy volunteers, greater in female patients', 'Patients with LQTS', 'healthy volunteers and patients with long QT syndrome', 'Thirty healthy volunteers and 10 patients with congenital LQTS', 'healthy volunteers', 'Healthy volunteers drank 2 L of']","['Grapefruit juice', 'moxifloxacin', 'grapefruit juice', '400 mg oral moxifloxacin']","['grapefruit juice', 'rate-corrected QT (QTc) prolongation', 'absolute net QTc prolongation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023976', 'cui_str': 'Long QT Syndrome'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0452456', 'cui_str': 'GRAPEFRUIT JUICE'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0452456', 'cui_str': 'GRAPEFRUIT JUICE'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]",30.0,0.0579027,The QT-prolonging effects of grapefruit in healthy volunteers were comparable with those of moxifloxacin.,"[{'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Chorin', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Aviram', 'Initials': 'A', 'LastName': 'Hochstadt', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Yoav', 'Initials': 'Y', 'LastName': 'Granot', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Shafik', 'Initials': 'S', 'LastName': 'Khoury', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Arie Lorin', 'Initials': 'AL', 'LastName': 'Schwartz', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Gilad', 'Initials': 'G', 'LastName': 'Margolis', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Barashi', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Viskin', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Eihab', 'Initials': 'E', 'LastName': 'Ghantous', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schnapper', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Mekori', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Fourey', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Milton Ernesto', 'Initials': 'ME', 'LastName': 'Guevara-Valdivia', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Manlio F', 'Initials': 'MF', 'LastName': 'Marquez', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zeltzer', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Rosso', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Viskin', 'Affiliation': 'Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: samiviskin@gmail.com.'}]",Heart rhythm,['10.1016/j.hrthm.2019.04.039']
1417,31703928,"Exercise, Dopamine, and Cognition in Older Age.","Jonasson et al. investigated whether individual differences in human dopamine receptors (D2R) were related to cognitive performance before and after a 6-month aerobic exercise intervention (compared with active control). While D2R decreased (perhaps counterintuitively) with exercise, there was no relationship between D2R and working memory at baseline or following exercise.",2019,"While D2R decreased (perhaps counterintuitively) with exercise, there was no relationship between D2R and working memory at baseline or following exercise.",['Older Age'],['aerobic exercise intervention'],"['Exercise, Dopamine, and Cognition', 'D2R and working memory']","[{'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",,0.0322311,"While D2R decreased (perhaps counterintuitively) with exercise, there was no relationship between D2R and working memory at baseline or following exercise.","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Juarez', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, USA; Center for Cognitive Neuroscience, Duke University, Durham, NC, USA. Electronic address: eric.juarez@duke.edu.'}, {'ForeName': 'Gregory R', 'Initials': 'GR', 'LastName': 'Samanez-Larkin', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, USA; Center for Cognitive Neuroscience, Duke University, Durham, NC, USA.'}]",Trends in cognitive sciences,['10.1016/j.tics.2019.10.006']
1418,31758326,Utility of topical agents for radiation dermatitis and pain: a randomized clinical trial.,"PURPOSE


Although topical agents are often provided during radiation therapy, there is limited consensus and evidence for their use prophylactically to prevent or reduce radiation dermatitis.
METHODS


This was a multi-site, randomized, placebo-controlled, blinded study of 191 breast cancer patients to compare the prophylactic effectiveness of three topical agents (Curcumin, HPR Plus™, and Placebo) for reducing radiation dermatitis and associated pain. Patients applied the topical agent to their skin in the radiation area site three times daily starting the first day of radiation therapy (RT) until 1 week after RT completion.
RESULTS


Of the 191 randomized patients, 171 patients were included in the final analyses (87.5% white females, mean age = 58 (range = 36-88)). Mean radiation dermatitis severity (RDS) scores did not significantly differ between study arms (Curcumin = 2.68 [2.49, 2.86]; HPR Plus™ = 2.64 [2.45, 2.82]; Placebo = 2.63 [2.44, 2.83]; p = 0.929). Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018). In patients with high breast field separation (≥ 25 cm), RDS scores (Curcumin = 2.70 [2.21, 3.19]; HPR Plus™ = 3.57 [3.16, 4.00]; Placebo = 2.95 [2.60, 3.30]; p = 0.024) and pain scores (Curcumin = 0.52 [- 0.28, 1.33]; HPR Plus™ = 0.55 [- 0.19, 1.30]; Placebo = 1.73 [0.97, 2.50]; p = 0.046) significantly differed at the end of RT.
CONCLUSIONS


Although there were no significant effects of the treatment groups on the overall population, our exploratory subgroup analysis suggests that prophylactic treatment with topical curcumin may be effective for minimizing skin reactions and pain for patients with high breast separation (≥ 25 cm) who may have the worst skin reactions.",2019,Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018).,"['radiation dermatitis and pain', '191 breast cancer patients', '191 randomized patients', '171 patients were included in the final analyses (87.5% white females, mean age = 58 (range = 36-88', 'patients with high breast separation (≥ 25 cm) who may have the worst skin reactions']","['placebo', 'topical agents', 'topical agents (Curcumin, HPR Plus™, and Placebo']","['pain scores', 'RDS scores', 'radiation dermatitis severity', 'prophylactic effectiveness', 'Mean radiation dermatitis severity (RDS) scores', 'skin reactions and pain', 'radiation dermatitis and associated pain']","[{'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0423754', 'cui_str': 'Poor skin condition (finding)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",191.0,0.2804,Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018).,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ryan Wolf', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA. julie_ryan@urmc.rochester.edu.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Gewandter', 'Affiliation': 'Department of Anesthesiology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bautista', 'Affiliation': 'URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Heckler', 'Affiliation': 'URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Strasser', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark, DE, USA.'}, {'ForeName': 'Pawal', 'Initials': 'P', 'LastName': 'Dyk', 'Affiliation': 'Heartland Cancer Research NCORP, St. Louis, MO, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': 'Columbus NCORP, Columbus, OH, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gross', 'Affiliation': 'Dayton Clinical Oncology Program, Dayton, OH, USA.'}, {'ForeName': 'Tod', 'Initials': 'T', 'LastName': 'Speer', 'Affiliation': 'Metro-Minnesota NCORP, St. Louis Park, MN, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Dolohanty', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bylund', 'Affiliation': 'Department Radiation Oncology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Pentland', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Morrow', 'Affiliation': 'URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05166-5']
1419,29165018,"Efficacy of an Individually Tailored, Internet-Mediated Physical Activity Intervention in Older Adults: A Randomized Controlled Trial.","OBJECTIVE


This study determined the effectiveness of an individually tailored, Internet-mediated physical activity (PA) intervention for increasing walking behavior in inactive older adults.
METHOD


This 12-week randomly controlled intervention divided participants ( N = 170) into three groups: control (CON, n = 51), pedometer only (PED, n = 62), and an individually tailored, Internet-mediated pedometer (TI-PED, n = 57) group. The PED group was instructed to increase weekly step count by 10% until 10,000 steps per day was achieved. The TI-PED group was given the same goal and received tailored feedback via an online platform. Changes in average step count pre-to-post were assessed.
RESULTS


Total retention rate at postintervention was 75.3%. PED ( p < .001) and TI-PED ( p < .001) increased step count pre-to-post, which was higher than the CON group at 12 weeks (PED, p < .001; TI-PED, p < .001). The TI-PED group had a higher step count at 12 weeks than the PED group ( p < .001).
DISCUSSION


Individually tailored, Internet-mediated PA interventions are an effective way to significantly increase PA in older adults.",2019,"The TI-PED group had a higher step count at 12 weeks than the PED group ( p < .001).
","['inactive older adults', 'Older Adults', 'older adults']","['Individually Tailored, Internet-Mediated Physical Activity Intervention', 'CON', 'Internet-mediated physical activity (PA) intervention']","['Total retention rate', 'walking behavior', 'TI-PED', 'PED']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",170.0,0.0424579,"The TI-PED group had a higher step count at 12 weeks than the PED group ( p < .001).
","[{'ForeName': 'Taylor W', 'Initials': 'TW', 'LastName': 'Rowley', 'Affiliation': '1 University of Wisconsin-Milwaukee, WI, USA.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Lenz', 'Affiliation': '2 The College at Brockport, NY, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Swartz', 'Affiliation': '1 University of Wisconsin-Milwaukee, WI, USA.'}, {'ForeName': 'Nora E', 'Initials': 'NE', 'LastName': 'Miller', 'Affiliation': '1 University of Wisconsin-Milwaukee, WI, USA.'}, {'ForeName': 'Hotaka', 'Initials': 'H', 'LastName': 'Maeda', 'Affiliation': '1 University of Wisconsin-Milwaukee, WI, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Strath', 'Affiliation': '1 University of Wisconsin-Milwaukee, WI, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464817735396']
1420,31157710,PERIPHERAL ISCHEMIC RETINAL PHOTOCOAGULATION IN ADDITION TO INTRAVITREAL BEVACIZUMAB VERSUS INTRAVITREAL BEVACIZUMAB ALONE FOR THE TREATMENT OF MACULAR EDEMA SECONDARY TO CENTRAL RETINAL VEIN OCCLUSION: A Randomized Double-Masked Controlled Clinical Trial.,"PURPOSE


To investigate the effects of peripheral ischemic retinal photocoagulation in addition to intravitreal bevacizumab (IVB) in the treatment of macular edema due to ischemic central retinal vein occlusion.
METHODS


Forty-eight eyes of 48 treatment-naive patients were randomly selected and divided into 2 groups. Group A comprised 24 eyes that were treated with three consecutive monthly injections of IVB, and Group B comprised 24 eyes that were treated with IVB plus photocoagulation of the peripheral nonperfused retina. Further IVB injections were administered as needed in both groups. Monthly follow-up was conducted for 9 months after the first injection.
RESULTS


The data of 46 patients were analyzed. Best-corrected visual acuity changes from the fourth to eighth month follow-up in comparison with the baseline were significantly higher in Group B (P = 0.002-0.044-0.002-0.002-0.012). In addition, significant differences were observed in central macular thickness in Group B throughout the study period (all P < 0.001). Group B required less frequent IVB injections during the 9-month study period.
CONCLUSION


Photocoagulation of the retinal nonperfused area in patients with macular edema because of central retinal vein occlusion might amplify the beneficial effects of IVB on best-corrected visual acuity and central macular thickness and reduce the frequency of IVB injection.",2020,Best-corrected visual acuity changes from the fourth to eighth month follow-up in comparison with the baseline were significantly higher in Group B (P = 0.002-0.044-0.002-0.002-0.012).,"['patients with macular edema', 'macular edema due to ischemic central retinal vein occlusion', '46 patients were analyzed', 'Forty-eight eyes of 48 treatment-naive patients']","['intravitreal bevacizumab (IVB', 'peripheral ischemic retinal photocoagulation', 'Photocoagulation', 'IVB plus photocoagulation of the peripheral nonperfused retina', 'IVB']","['central macular thickness', 'Best-corrected visual acuity changes', 'frequent IVB injections', 'frequency of IVB injection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0154841', 'cui_str': 'Central retinal vein occlusion (disorder)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0035298', 'cui_str': 'Retina'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",46.0,0.0875688,Best-corrected visual acuity changes from the fourth to eighth month follow-up in comparison with the baseline were significantly higher in Group B (P = 0.002-0.044-0.002-0.002-0.012).,"[{'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Nourinia', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Emamverdi', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ramezani', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Yashar', 'Initials': 'Y', 'LastName': 'Amizadeh', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Khorshidifar', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Behnaz', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sare', 'Initials': 'S', 'LastName': 'Safi', 'Affiliation': 'Ophthalmic Epidemiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002573']
1421,31155169,Comparing intranasal ketamine with intravenous fentanyl in reducing pain in patients with renal colic: A double-blind randomized clinical trial.,"BACKGROUND


Kidney stones are a fairly common problem that manifests itself as symptoms of acute abdominal and flank pains in patients presenting to emergency departments.
OBJECTIVE


The present study was conducted to compare the analgesic effect of intravenous fentanyl with that of intranasal ketamine in renal colic patients.
METHODS


One mg/kg of intranasal ketamine was administered in the first group, and one μg/kg of intravenous fentanyl in the second group. The pain severity was measured in the patients in terms of a visual analogue scale (VAS) score at the beginning of the study and at minutes 5, 15 and 30, and the medication side-effects were evaluated and recorded.
RESULTS


A total of 130 patients were ultimately assessed in two groups of 65. In the ketamine group, the mean severity of pain was 8.72 ± 1.52 at the beginning of the study (P < 0.001), 5.5 ± 2.97 at minute 5 (P < 0.001), 3.38 ± 3.35 at minute 15 (P = 0.004) and 2.53 ± 3.41 at minute 30 (P = 0.449). In the fentanyl group, this severity was 9.66 ± 88.8 in the beginning of the study (P < 0.001), 7.27 ± 1.37 at minute 5 (P < 0.001), 4.61 ± 1.5 at minute 15 (P = 0.004) and 1.24 ± 1.25 at minute 30 (P = 0.449). The general prevalence of the medication side-effects was 10 (15.4%) in the ketamine group and 1 (1.5%) in the fentanyl group (P = 0.009).
CONCLUSIONS


Ketamine was found to be less effective than fentanyl in controlling renal colic-induced pain, and to be associated with a higher prevalence of side-effects; nevertheless, ketamine can be effective in controlling this pain in conjunction with other medications.",2020,"The general prevalence of the medication side-effects was 10 (15.4%) in the ketamine group and 1 (1.5%) in the fentanyl group (P = 0.009).
","['130 patients were ultimately assessed in two groups of 65', 'patients with renal colic', 'patients presenting to emergency departments', 'renal colic patients']","['ketamine', 'fentanyl', 'intranasal ketamine', 'Ketamine', 'intravenous fentanyl']","['visual analogue scale (VAS) score', 'pain', 'mean severity of pain', 'analgesic effect', 'pain severity']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",130.0,0.114413,"The general prevalence of the medication side-effects was 10 (15.4%) in the ketamine group and 1 (1.5%) in the fentanyl group (P = 0.009).
","[{'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Mozafari', 'Affiliation': 'Assistant professor of Emergency Medicine, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Maleki Verki', 'Affiliation': 'Assistant professor of Emergency Medicine, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: drmalaki676@yahoo.com.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Motamed', 'Affiliation': 'Assistant professor of Emergency Medicine, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sabouhi', 'Affiliation': 'Emergency Medicine Specialist, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Tirandaz', 'Affiliation': 'Assistant professor of Emergency Medicine, Department of Emergency Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.05.049']
1422,29437501,The Significance of Uvula After Palatoplasty: A New Technique to Improve the Aesthetic Outcome.,"OBJECTIVE


This study aims to examine the importance of the uvula as a part of palatoplasty outcome and to assess the aesthetic results of the conventional versus a new technique for uvuloplasty.
DESIGN/PARTICIPANTS


The study included 2 groups of patients undergoing palatoplasty. Group I consisted of 20 cleft palate patients repaired with the conventional uvula repair, combining the 2 hemi-uvulae. Group II consisted of 20 patients repaired with our new technique, sacrificing one hemi-uvula and centralizing the remaining one. The aesthetic outcome was assessed in both groups. A questionnaire was distributed to the families of both groups to assess their concern about the uvula after palate repair.
SETTING


Cleft unit at a tertiary care center.
RESULTS


Sixty-five percent of parents considered the uvula as important functionally and aesthetically after palate repair whereas 35% either did not care or were not sure about its importance. Results of the aesthetic outcome of the 2 techniques for uvula reconstruction showed that uvula was absent in 4 cases in group I versus 1 in group II ( P > .05), small in 8 cases of group I versus 4 in group II ( P > .05), bifid in 5 cases of group I versus none in group II ( P < .05), became deviated in no case of group I versus 4 in group II ( P > .05), and was satisfactory in 3 cases of group I versus 11 in group II ( P < .05).
CONCLUSIONS


Among the respondents, the uvula was a significant concern to the parents of cleft patients and should be given more attention during repair. The described technique had better aesthetic outcome over the conventional one of combining the 2 hemi-uvulae.",2018,"Results of the aesthetic outcome of the 2 techniques for uvula reconstruction showed that uvula was absent in 4 cases in group I versus 1 in group II ( P > .05), small in 8 cases of group I versus 4 in group II ( P > .05), bifid in 5 cases of group I versus none in group II ( P < .05), became deviated in no case of group","['Cleft unit at a tertiary care center', '2 groups of patients undergoing palatoplasty']","['20 cleft palate patients repaired with the conventional uvula repair, combining the 2 hemi-uvulae', 'Palatoplasty']",['aesthetic outcome'],"[{'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337358', 'cui_str': 'Repair of palate'}]","[{'cui': 'C0432098', 'cui_str': 'Cleft Soft Palate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0042173', 'cui_str': 'Uvula'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0337358', 'cui_str': 'Repair of palate'}]","[{'cui': 'C0014901', 'cui_str': 'Esthetics'}]",,0.0177089,"Results of the aesthetic outcome of the 2 techniques for uvula reconstruction showed that uvula was absent in 4 cases in group I versus 1 in group II ( P > .05), small in 8 cases of group I versus 4 in group II ( P > .05), bifid in 5 cases of group I versus none in group II ( P < .05), became deviated in no case of group","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elsherbiny', 'Affiliation': '1 Sohag Cleft and Craniofacial Unit, Plastic Surgery Department, Sohag University Hospital, Sohag, Egypt.'}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Mazeed', 'Affiliation': '1 Sohag Cleft and Craniofacial Unit, Plastic Surgery Department, Sohag University Hospital, Sohag, Egypt.'}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Saied', 'Affiliation': '1 Sohag Cleft and Craniofacial Unit, Plastic Surgery Department, Sohag University Hospital, Sohag, Egypt.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Grant', 'Affiliation': ""2 Cleft and Craniofacial Center, Children's of Alabama Hospital, University of Birmingham, Birmingham, AL, USA.""}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665617736776']
1423,30385886,Disparities in genetic services utilization in a random sample of young breast cancer survivors.,"PURPOSE


Increasing use of genetic services (counseling/testing) among young breast cancer survivors (YBCS) can help decrease breast cancer incidence and mortality. The study examined use of genetic services between Black and White/Other YBCS, attitudes and knowledge of breast cancer risk factors, and reasons for disparities in using genetic services.
METHODS


We used baseline data from a randomized control trial including a population-based, stratified random sample of 3000 potentially eligible YBCS, with oversampling of Black YBCS.
RESULTS


Among 883 YBCS (353 Black, 530 White/Other) were significant disparities between the two racial groups. More White/Other YBCS had received genetic counseling and had genetic testing than Blacks. Although White/Other YBCS resided farther away from board-certified genetic counseling centers, they had fewer barriers to access these services. Black race, high out-of-pocket costs, older age, and more years since diagnosis were negatively associated with use of genetic services. Black YBCS had lower knowledge of breast cancer risk factors. Higher education and genetic counseling were associated with higher genetic knowledge.
CONCLUSION


Racial inequalities of cost-related access to care and education create disparities in genetic services utilization. System-based interventions that reduce socioeconomic disparities and empower YBCS with genetic knowledge, as well as physician referrals, can increase access to genetic services.",2019,"Among 883 YBCS (353 Black, 530 White/Other) were significant disparities between the two racial groups.","['a population-based, stratified random sample of 3000 potentially eligible YBCS, with oversampling of Black YBCS', 'young breast cancer survivors', 'young breast cancer survivors (YBCS']","['Black YBCS', 'YBCS', 'genetic services (counseling/testing']","['breast cancer incidence and mortality', 'knowledge of breast cancer risk factors']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3887703', 'cui_str': 'Genetics service (procedure)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",3000.0,0.0157258,"Among 883 YBCS (353 Black, 530 White/Other) were significant disparities between the two racial groups.","[{'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Nikolaidis', 'Affiliation': 'Nursing Science, Faculty of Medicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Duquette', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Kari E', 'Initials': 'KE', 'LastName': 'Mendelsohn-Victor', 'Affiliation': 'University of Michigan School of Nursing, Ann Arbor, MI, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Anderson', 'Affiliation': 'Michigan Department of Health and Human Services, Lansing, MI, USA.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Copeland', 'Affiliation': 'Michigan Department of Health and Human Services, Lansing, MI, USA.'}, {'ForeName': 'Kara J', 'Initials': 'KJ', 'LastName': 'Milliron', 'Affiliation': 'Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sofia D', 'Initials': 'SD', 'LastName': 'Merajver', 'Affiliation': 'University of Michigan School of Public Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Janz', 'Affiliation': 'University of Michigan School of Public Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Laurel L', 'Initials': 'LL', 'LastName': 'Northouse', 'Affiliation': 'University of Michigan School of Nursing, Ann Arbor, MI, USA.'}, {'ForeName': 'Sonia A', 'Initials': 'SA', 'LastName': 'Duffy', 'Affiliation': 'Ohio State University College of Nursing, Columbus, OH, USA.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Katapodi', 'Affiliation': 'Nursing Science, Faculty of Medicine, University of Basel, Basel, Switzerland. maria.katapodi@unibas.ch.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-018-0349-1']
1424,31155413,A post-hoc analysis of serotype-specific vaccine efficacy of 13-valent pneumococcal conjugate vaccine against clinical community acquired pneumonia from a randomized clinical trial in the Netherlands.,"BACKGROUND


Serotype-specific vaccine efficacy (VE) against adult community acquired pneumonia (CAP) remains poorly defined, yet such data are important for assessing the utility of adult pneumococcal conjugate vaccine (PCV) programs.
METHODS


We evaluated the Community Acquired Pneumonia Immunization Trial in Adults to assess serotype-specific VE for CAP. This parallel-arm randomized clinical trial assessed 13-valent PCV (PCV13) VE among community dwelling persons aged ≥65 years in The Netherlands. In the original analysis, PCV13 VE against first episodes of vaccine-type (VT) chest radiology confirmed CAP was 45.6% (95% confidence interval [CI] 21.8-62.5%). Unlike the original analysis, we included any subject that met a clinical definition of CAP regardless of radiographic findings. VT-CAP was identified by culture (sterile or non-sterile) or serotype-specific urinary antigen detection (SSUAD) test. Only the five serotypes with at least 10 episodes in the control arm, based on the original analysis, were included for VE assessment.
RESULTS


Of 272 clinical CAP visits with VT serotypes identified, 253 (93%) were identified by SSUAD including 210 (77%) by SSUAD alone. VE was determined for serotypes 1, 3, 6A, 7F, and 19A, with total first episodes of, respectively, 27, 36, 25, 38, and 48. VE (95%CI) for the five evaluated serotypes against first clinical CAP episodes were: serotype 1, 20.0% (-83.1% to 65.8%); serotype 3, 61.5% (17.6-83.4%); serotype 6A, 33.3% (-58.6% to 73.2%); serotype 7F, 73.3% (40.5-89.4%); and serotype 19A, 45.2% (-2.2% to 71.5%).
DISCUSSION


Statistically significant VE was observed for serotypes 3 and 7F for clinical CAP among elderly community dwelling adults. The VE point estimates and CIs for serotypes 1, 6A, and 19A were lower but consistent with the overall VT-CAP VE of 45.6% previously reported. These findings may be relevant in models to accurately account for the potential impact of adult PCV13 immunization.",2019,Statistically significant VE was observed for serotypes 3 and 7F for clinical CAP among elderly community dwelling adults.,"['elderly community dwelling adults', 'community dwelling persons aged ≥65\u202fyears in The Netherlands', 'Adults to assess serotype-specific VE for CAP', 'adult community acquired pneumonia (CAP']","['13-valent PCV (PCV13) VE', '13-valent pneumococcal conjugate vaccine']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}]","[{'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}]",[],,0.180764,Statistically significant VE was observed for serotypes 3 and 7F for clinical CAP among elderly community dwelling adults.,"[{'ForeName': 'Bradford D', 'Initials': 'BD', 'LastName': 'Gessner', 'Affiliation': 'Pfizer Vaccines, Collegeville, PA, USA. Electronic address: Bradford.gessner@Pfizer.com.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Pfizer Vaccines, Collegeville, PA, USA.'}, {'ForeName': 'Cornelis H', 'Initials': 'CH', 'LastName': 'Van Werkhoven', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Sings', 'Affiliation': 'Pfizer Vaccines, Collegeville, PA, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Webber', 'Affiliation': 'Pfizer Vaccines, Clinical Research and Development, Hurley, United Kingdom; Pearl River, NY, USA; Collegeville, PA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Scott', 'Affiliation': 'Pfizer Vaccines, Clinical Research and Development, Hurley, United Kingdom; Pearl River, NY, USA; Collegeville, PA, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Pfizer Vaccines, Clinical Research and Development, Hurley, United Kingdom; Pearl River, NY, USA; Collegeville, PA, USA.'}, {'ForeName': 'Diederick E', 'Initials': 'DE', 'LastName': 'Grobbee', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, the Netherlands; Julius Clinical, Academic Contract Research Organization, Zeist, the Netherlands.'}, {'ForeName': 'Marc J M', 'Initials': 'MJM', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, the Netherlands; Department of Medical Microbiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Jodar', 'Affiliation': 'Pfizer Vaccines, Collegeville, PA, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.05.065']
1425,31152334,Do treatment effects of a web-based cognitive behavioral therapy for insomnia intervention differ for users with and without pain interference? A secondary data analysis.,"Cognitive-behavioral therapy for insomnia (CBT-I) shows treatment benefits among individuals with pain interference; however, effects of Internet-delivered CBT-I for this population are unknown. This secondary analysis used randomized clinical trial data from adults assigned to Internet-delivered CBT-I to compare changes in sleep by pre-intervention pain interference. Participants (N = 151) completed the Insomnia Severity Index (ISI) and sleep diaries [sleep onset latency (SOL); wake after sleep onset (WASO)] at baseline, post-assessment, 6- and 12-month follow-ups. Linear mixed-effects models showed no differences between pain interference groups (no, some, moderate/severe) for changes from baseline to any follow-up timepoint for ISI (p = .72) or WASO (p = .88). There was a small difference in SOL between those reporting some versus no or moderate/severe pain interference (p = .04). Predominantly comparable and sustained treatment benefits for both those with and without pain interference suggest that Internet-delivered CBT-I is promising for delivering accessible care to individuals with comorbid pain and insomnia.",2020,"Linear mixed-effects models showed no differences between pain interference groups (no, some, moderate/severe) for changes from baseline to any follow-up timepoint for ISI (p = .72) or WASO (p = .88).",['individuals with pain interference'],"['web-based cognitive behavioral therapy', 'Cognitive-behavioral therapy']","['Insomnia Severity Index (ISI) and sleep diaries [sleep onset latency (SOL); wake after sleep onset (WASO', 'SOL', 'severe pain interference']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0701413', 'cui_str': 'Sol'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",,0.100234,"Linear mixed-effects models showed no differences between pain interference groups (no, some, moderate/severe) for changes from baseline to any follow-up timepoint for ISI (p = .72) or WASO (p = .88).","[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Shaffer', 'Affiliation': 'Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, PO Box 801075, Charlottesville, VA, 22908, USA. kshaffer@virginia.edu.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Camacho', 'Affiliation': 'Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, PO Box 801075, Charlottesville, VA, 22908, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Lord', 'Affiliation': 'Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, PO Box 801075, Charlottesville, VA, 22908, USA.'}, {'ForeName': 'Philip I', 'Initials': 'PI', 'LastName': 'Chow', 'Affiliation': 'Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, PO Box 801075, Charlottesville, VA, 22908, USA.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Palermo', 'Affiliation': ""Center for Child Health and Development, Seattle Children's Research Institute, Seattle, USA.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Law', 'Affiliation': ""Center for Child Health and Development, Seattle Children's Research Institute, Seattle, USA.""}, {'ForeName': 'Frances P', 'Initials': 'FP', 'LastName': 'Thorndike', 'Affiliation': 'Pear Therapeutics, Inc., Boston, USA.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'Ingersoll', 'Affiliation': 'Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, PO Box 801075, Charlottesville, VA, 22908, USA.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Ritterband', 'Affiliation': 'Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, PO Box 801075, Charlottesville, VA, 22908, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00065-w']
1426,30914500,n-3 PUFAs improve erythrocyte fatty acid profile in patients with small AAA: a randomized controlled trial.,"Abdominal aortic aneurysm (AAA) is an important cause of death in older adults, which has no current drug therapy. Inflammation and abnormal redox status are believed to be key pathogenic mechanisms for AAA. In light of evidence correlating inflammation with aberrant fatty acid profiles, this study compared erythrocyte fatty acid content in 43 AAA patients (diameter 3.0-4.5 cm) and 52 healthy controls. In addition, the effect of omega-3 PUFA (n-3 PUFA) supplementation on erythrocyte fatty acid content was examined in a cohort of 30 AAA patients as part of a 12 week randomized placebo-controlled clinical trial. Blood analyses identified associations between AAA and decreased linoleic acid (LA), and AAA and increased Δ6-desaturase activity and biosynthesis of arachidonic acid (AA) from LA. Omega-3 PUFA supplementation (1.5 g DHA + 0.3 g EPA/day) decreased red blood cell distribution width (14.8 ± 0.4% to 13.8 ± 0.2%;  P  = 0.003) and levels of pro-inflammatory n-6 PUFAs (AA, 12.46 ± 0.23% to 10.14 ± 0.3%,  P  < 0.001; adrenic acid, 2.12 ± 0.13% to 1.23 ± 0.09%;  P  < 0.001). In addition, Δ-4 desaturase activity increased (DHA/docosapentaenoic acid ratio, 1.85 ± 0.14 to 3.93 ± 0.17;  P  < 0.001) and elongase 2/5 activity decreased (adrenic acid/AA ratio, 0.17 ± 0.01 to 0.12 ± 0.01;  P  < 0.01) following supplementation. The findings suggest that n-3 PUFAs improve fatty acid profiles and ameliorate factors associated with inflammation in AAA patients.",2019,"In addition, Δ-4 desaturase activity increased (DHA/docosapentaenoic acid ratio, 1.85 ± 0.14 to 3.93 ± 0.17;  P  < 0.001) and elongase 2/5 activity decreased (adrenic acid/AA ratio, 0.17 ± 0.01 to 0.12 ± 0.01;  P  < 0.01) following supplementation.","['43 AAA patients (diameter 3.0-4.5 cm) and 52 healthy controls', 'patients with small AAA', 'older adults']","['Abdominal aortic aneurysm (AAA', 'n-3 PUFAs', 'omega-3 PUFA (n-3 PUFA) supplementation', 'placebo']","['linoleic acid (LA), and AAA and increased Δ6-desaturase activity and biosynthesis of arachidonic acid (AA', 'erythrocyte fatty acid profile', 'red blood cell distribution width', 'levels of pro-inflammatory n-6 PUFAs', 'erythrocyte fatty acid content', 'Δ-4 desaturase activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0162871', 'cui_str': 'Aortic Aneurysm, Abdominal'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023750', 'cui_str': 'Linoleic Acids'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",30.0,0.112601,"In addition, Δ-4 desaturase activity increased (DHA/docosapentaenoic acid ratio, 1.85 ± 0.14 to 3.93 ± 0.17;  P  < 0.001) and elongase 2/5 activity decreased (adrenic acid/AA ratio, 0.17 ± 0.01 to 0.12 ± 0.01;  P  < 0.01) following supplementation.","[{'ForeName': 'Lara T', 'Initials': 'LT', 'LastName': 'Meital', 'Affiliation': 'GeneCology Research Centre, University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Windsor', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Rebecca M L', 'Initials': 'RML', 'LastName': 'Ramirez Jewell', 'Affiliation': 'GeneCology Research Centre, University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Technical Services University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Schulze', 'Affiliation': 'Sunshine Vascular, Buderim, Queensland, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Magee', 'Affiliation': 'Sunshine Coast University Hospital Birtinya, Queensland, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': ""O'Donnell"", 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Jha', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Perissiou', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Golledge', 'Affiliation': 'Queensland Research Centre for Peripheral Vascular Disease College of Medicine and Dentistry, James Cook University and Department of Vascular and Endovascular Surgery, Townsville Hospital, Townsville, Australia; and.'}, {'ForeName': 'Tom G', 'Initials': 'TG', 'LastName': 'Bailey', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brooks', 'Affiliation': 'Centre for Genetics, Ecology, and Physiology, School of Science and Engineering University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Askew', 'Affiliation': 'VasoActive Research Group, School of Health and Sport Sciences University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Fraser D', 'Initials': 'FD', 'LastName': 'Russell', 'Affiliation': 'GeneCology Research Centre, University of the Sunshine Coast, Queensland, Australia frussell@usc.edu.au.'}]",Journal of lipid research,['10.1194/jlr.P093013']
1427,31754238,Exercise effects on arterial stiffness and heart health in children with excess weight: The SMART RCT.,"INTRODUCTION


Childhood obesity and inactivity are associated with cardiovascular risk. Evidence is limited for exercise effects on arterial health in children.
METHODS


One hundred and seventy-five inactive children with overweight or obesity (8-11 years, ≥85th percentile BMI, 61% female, 87% Black, 73% with obesity) were randomized to an 8-month daily after-school aerobic exercise program (40 min/day, n = 90) or a sedentary control condition (n = 85). Carotid-femoral pulse wave velocity (PWV, primary outcome, arterial stiffness), fitness, adiposity, blood pressure (BP), glucose, insulin resistance, lipids, and C-reactive protein were measured at baseline and posttest (8 months). Adiposity, fitness, and BP were measured again at follow-up, 8-12 months later. Intent-to-treat analyses were conducted using mixed models.
RESULTS


The study had 89% retention, with attendance of 59% in exercise and 64% in the control condition, and vigorous exercise participation (average heart rate 161 ± 7 beats/min). Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001). There was no group × time effect on other outcomes at 8 months, or on any outcomes at follow-up. The change in PWV at 8 months correlated with changes in insulin and insulin resistance (both r = 0.32), diastolic BP (r = 0.24), BMI (r = 0.22), and adiposity (r = 0.18).
CONCLUSIONS


Eight months of aerobic exercise training improved fitness, adiposity, and HDL-cholesterol levels, but did not reduce arterial stiffness in children with excess weight. PWV improved as a function of insulin resistance, BP, BMI, and adiposity. Weight loss may be required to improve arterial stiffness. Exercise benefits waned after discontinuing the program.",2020,"Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001).","['children', 'children with excess weight', 'The study had 89% retention, with attendance of 59% in exercise and 64% in the control condition, and vigorous exercise participation (average heart rate 161\u2009±\u20097 beats/min', 'One hundred and seventy-five inactive children with overweight or obesity (8-11 years, ≥85th percentile BMI, 61% female, 87% Black, 73% with obesity']","['school aerobic exercise program (40\u2009min/day, n\u2009=\u200990) or a sedentary control condition', 'aerobic exercise training']","['insulin and insulin resistance', 'Adiposity, fitness, and BP', 'arterial stiffness', 'function of insulin resistance, BP, BMI, and adiposity', 'fitness, adiposity, and HDL-cholesterol levels', 'Weight loss', 'HDL-cholesterol', 'adiposity', 'arterial stiffness and heart health', 'diastolic BP', 'BMI', 'Carotid-femoral pulse wave velocity (PWV, primary outcome, arterial stiffness), fitness, adiposity, blood pressure (BP), glucose, insulin resistance, lipids, and C-reactive protein', 'change in PWV']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0556973', 'cui_str': 'mins/day'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",175.0,0.0968893,"Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001).","[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Davis', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA. katie.davis@augusta.edu.'}, {'ForeName': 'Sheldon E', 'Initials': 'SE', 'LastName': 'Litwin', 'Affiliation': 'Cardiology, Medicine, MCG, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Norman K', 'Initials': 'NK', 'LastName': 'Pollock', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Waller', 'Affiliation': 'Population Health Sciences, MCG, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'Kapuku', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jigar', 'Initials': 'J', 'LastName': 'Bhagatwala', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Looney', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Celestine F', 'Initials': 'CF', 'LastName': 'Williams', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Armento', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Schmidt', 'Affiliation': 'Kinesiology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Bassali', 'Affiliation': 'Pediatrics, MCG, Augusta University, Augusta, GA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0482-1']
1428,31129092,2-Year Clinical Outcomes of an Abluminal Groove-Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent.,"OBJECTIVES


The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove-filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent.
BACKGROUND


The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial.
METHODS


The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization.
RESULTS


At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34).
CONCLUSIONS


The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.",2019,Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent.,"['1,653 patients']","['Firehawk stent', 'Firehawk or the XIENCE stent', 'Firehawk stent, a novel abluminal groove-filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE', 'Abluminal Groove-Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent']","['late definite or probable stent thrombosis', 'safety and efficacy profiles', 'target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization', 'TLF', 'incidence of target lesion failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",1653.0,0.1022,Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent.,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Fu Wai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baumbach', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut; Barts Heart Centre, London and Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbæk', 'Affiliation': 'Department of Cardiology, Roskilde University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, VU University Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Shanghai MicroPort Medical (Group) Co., Ltd., Shanghai, China.'}, {'ForeName': 'Marie-Angèle', 'Initials': 'MA', 'LastName': 'Morel', 'Affiliation': 'Cardialysis, Rotterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knaapen', 'Affiliation': 'Department of Cardiology, VU University Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Slagboom', 'Affiliation': 'Amsterdam Department of Interventional Cardiolody, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Johnson', 'Affiliation': 'Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Vlachojannis', 'Affiliation': 'Division Heart and Lungs, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Karin E', 'Initials': 'KE', 'LastName': 'Arkenbout', 'Affiliation': 'Department of Cardiology, Tergooi Ziekenhuis, Blaricum, the Netherlands.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Holmvang', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Heart Centre, Imelda Ziekenhuis, Bonheiden, Belgium.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Ochala', 'Affiliation': 'Department of Invasive Cardiology, Silesian Medical University, Katowice, Poland.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Christoph K', 'Initials': 'CK', 'LastName': 'Naber', 'Affiliation': 'Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus, Essen, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'Department of Cardiology, University Hospital of Wales, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Rittger', 'Affiliation': 'Medizinische Klinik I, Klinikum Fürth, University of Erlangen, Fürth, Germany.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Berti', 'Affiliation': 'UOC Cardiologia Diagnostica ed Interventistica, Fondazione C.N.R. Reg. Toscana G. Monasterio, Ospedale del Cuore, Massa, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Cardiovascular Research Centre Aalst, OLV Hospital, Aalst, Belgium; Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Gabor G', 'Initials': 'GG', 'LastName': 'Toth', 'Affiliation': 'Department of Cardiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Maillard', 'Affiliation': 'Service de Cardiologie, Clinique Axium, Aix-en-Provence, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Valina', 'Affiliation': 'Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'American Heart of Poland, Katowice, Poland.'}, {'ForeName': 'Holge', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Herzzentrum Leipzig, Leipzig, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Schächinger', 'Affiliation': 'Medizinische Klinik I, Herz-Thorax Zentrum, Klinikum Fulda, Fulda, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Lansky', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut; Barts Heart Centre, London and Queen Mary University of London, London, United Kingdom. Electronic address: alexandra.lansky@yale.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, and Saolta University Healthcare Group, University College Hospital Galway, Galway, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.05.001']
1429,31079849,mRNA vaccines against H10N8 and H7N9 influenza viruses of pandemic potential are immunogenic and well tolerated in healthy adults in phase 1 randomized clinical trials.,"BACKGROUND


We evaluated safety and immunogenicity of the first mRNA vaccines against potentially pandemic avian H10N8 and H7N9 influenza viruses.
METHODS


Two randomized, placebo-controlled, double-blind, phase 1 clinical trials enrolled participants between December 2015 and August 2017 at single centers in Germany (H10N8) and USA (H7N9). Healthy adults (ages 18-64 years for H10N8 study; 18-49 years for H7N9 study) participated. Participants received vaccine or placebo in a 2-dose vaccination series 3 weeks apart. H10N8 intramuscular (IM) dose levels of 25, 50, 75, 100, and 400 µg and intradermal dose levels of 25 and 50 µg were evaluated. H7N9 IM 10-, 25-, and 50-µg dose levels were evaluated; 2-dose series 6 months apart was also evaluated. Primary endpoints were safety (adverse events) and tolerability. Secondary immunogenicity outcomes included humoral (hemagglutination inhibition [HAI], microneutralization [MN] assays) and cell-mediated responses (ELISPOT assay).
RESULTS


H10N8 and H7N9 mRNA IM vaccines demonstrated favorable safety and reactogenicity profiles. No vaccine-related serious adverse event was reported. For H10N8 (N = 201), 100-µg IM dose induced HAI titers ≥ 1:40 in 100% and MN titers ≥ 1:20 in 87.0% of participants. The 25-µg intradermal dose induced HAI titers > 1:40 in 64.7% of participants compared to 34.5% of participants receiving the IM dose. For H7N9 (N = 156), IM doses of 10, 25, and 50 µg achieved HAI titers ≥ 1:40 in 36.0%, 96.3%, and 89.7% of participants, respectively. MN titers ≥ 1:20 were achieved by 100% in the 10- and 25-µg groups and 96.6% in the 50-µg group. Seroconversion rates were 78.3% (HAI) and 87.0% (MN) for H10N8 (100 µg IM) and 96.3% (HAI) and 100% (MN) in H7N9 (50 µg). Significant cell-mediated responses were not detected in either study.
CONCLUSIONS


The first mRNA vaccines against H10N8 and H7N9 influenza viruses were well tolerated and elicited robust humoral immune responses. ClinicalTrials.gov NCT03076385 and NCT03345043.",2019,The 25-µg intradermal dose induced HAI titers > 1:40 in 64.7% of participants compared to 34.5% of participants receiving the IM dose.,"['Healthy adults (ages 18-64\u202fyears for H10N8 study; 18-49\u202fyears for H7N9 study) participated', 'H10N8', 'healthy adults', 'participants between December 2015 and August 2017 at single centers in Germany (H10N8) and USA (H7N9']","['vaccine or placebo', 'placebo', 'IM vaccines', 'H7N9 mRNA']","['safety (adverse events) and tolerability', 'Seroconversion rates', 'favorable safety and reactogenicity profiles', 'Significant cell-mediated responses', 'humoral (hemagglutination inhibition [HAI], microneutralization [MN] assays) and cell-mediated responses (ELISPOT assay', 'tolerated and elicited robust humoral immune responses', 'HAI titers']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0920508', 'cui_str': 'ELISPOT'}, {'cui': 'C1155229'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.15862,The 25-µg intradermal dose induced HAI titers > 1:40 in 64.7% of participants compared to 34.5% of participants receiving the IM dose.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Feldman', 'Affiliation': 'Miami Research Associates, 6280 Sunset Drive, Suite 600, So. Miami, FL 33143, USA.'}, {'ForeName': 'Rainard', 'Initials': 'R', 'LastName': 'Fuhr', 'Affiliation': 'PAREXEL International GmbH Klinikum Westend, House 18, Spandauer Damm 130, 14050 Berlin, Germany. Electronic address: Rainard.Fuhr@parexel.com.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Smolenov', 'Affiliation': 'Moderna, 500 Technology Square, Cambridge, MA 02139, USA.'}, {'ForeName': 'Amilcar', 'Initials': 'A', 'LastName': 'Mick Ribeiro', 'Affiliation': 'Moderna, 500 Technology Square, Cambridge, MA 02139, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Panther', 'Affiliation': 'Moderna, 500 Technology Square, Cambridge, MA 02139, USA. Electronic address: Lori.Panther@modernatx.com.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Watson', 'Affiliation': 'Moderna, 500 Technology Square, Cambridge, MA 02139, USA. Electronic address: mike.watson@modernatx.com.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Senn', 'Affiliation': 'Moderna, 500 Technology Square, Cambridge, MA 02139, USA. Electronic address: Joe.senn@modernatx.com.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'Moderna, 500 Technology Square, Cambridge, MA 02139, USA. Electronic address: Mike.smith@modernatx.com.'}, {'ForeName': 'Ӧrn', 'Initials': 'Ӧ', 'LastName': 'Almarsson', 'Affiliation': 'Moderna, 500 Technology Square, Cambridge, MA 02139, USA. Electronic address: Orn.almarsson@modernatx.com.'}, {'ForeName': 'Hari S', 'Initials': 'HS', 'LastName': 'Pujar', 'Affiliation': 'Moderna, 500 Technology Square, Cambridge, MA 02139, USA. Electronic address: Hari.pujar@modernatx.com.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Laska', 'Affiliation': 'Moderna, 500 Technology Square, Cambridge, MA 02139, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Moderna, 500 Technology Square, Cambridge, MA 02139, USA. Electronic address: James.thompson@modernatx.com.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Zaks', 'Affiliation': 'Moderna, 500 Technology Square, Cambridge, MA 02139, USA. Electronic address: Tal.zaks@modernatx.com.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Ciaramella', 'Affiliation': 'Moderna, 500 Technology Square, Cambridge, MA 02139, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.04.074']
1430,31754645,Delta oscillations phase limit neural activity during sevoflurane anesthesia.,"Understanding anesthetic mechanisms with the goal of producing anesthetic states with limited systemic side effects is a major objective of neuroscience research in anesthesiology. Coherent frontal alpha oscillations have been postulated as a mechanism of sevoflurane general anesthesia. This postulate remains unproven. Therefore, we performed a single-site, randomized, cross-over, high-density electroencephalogram study of sevoflurane and sevoflurane- plus -ketamine general anesthesia in 12 healthy subjects. Data were analyzed with multitaper spectral, global coherence, cross-frequency coupling, and phase-dependent methods. Our results suggest that coherent alpha oscillations are not fundamental for maintaining sevoflurane general anesthesia. Taken together, our results suggest that subanesthetic and general anesthetic sevoflurane brain states emerge from impaired information processing instantiated by a delta-higher frequency phase-amplitude coupling syntax. These results provide fundamental new insights into the neural circuit mechanisms of sevoflurane anesthesia and suggest that anesthetic states may be produced by extracranial perturbations that cause delta-higher frequency phase-amplitude interactions.",2019,Our results suggest that coherent alpha oscillations are not fundamental for maintaining sevoflurane general anesthesia.,['12 healthy subjects'],"['sevoflurane and sevoflurane- plus -ketamine general anesthesia', 'sevoflurane anesthesia']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]",[],12.0,0.137912,Our results suggest that coherent alpha oscillations are not fundamental for maintaining sevoflurane general anesthesia.,"[{'ForeName': 'Shubham', 'Initials': 'S', 'LastName': 'Chamadia', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Pedemonte', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Eunice Y', 'Initials': 'EY', 'LastName': 'Hahm', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mekonnen', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Reine', 'Initials': 'R', 'LastName': 'Ibala', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Gitlin', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Breanna R', 'Initials': 'BR', 'LastName': 'Ethridge', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Vazquez', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rhee', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Erika T', 'Initials': 'ET', 'LastName': 'Liao', 'Affiliation': '3Tulane University of Medicine, New Orleans, LA 70112 USA.'}, {'ForeName': 'Emery N', 'Initials': 'EN', 'LastName': 'Brown', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}, {'ForeName': 'Oluwaseun', 'Initials': 'O', 'LastName': 'Akeju', 'Affiliation': '1Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114 USA.'}]",Communications biology,['10.1038/s42003-019-0664-3']
1431,31145833,Association between advanced cancer patient-caregiver agreement regarding prognosis and hospice enrollment.,"BACKGROUND


Patients with advanced, incurable cancer who understand their illness is incurable are more likely to prefer hospice care at the end of life compared with patients who believe their illness is curable. To the authors' knowledge, it is unclear whether patient-caregiver agreement regarding perceived prognosis is associated with hospice enrollment.
METHODS


The current study examined the prospective relationship between patient-caregiver agreement concerning perceived prognosis and hospice enrollment in the last 30 days of life. Data were collected during a cluster randomized controlled trial examining a communication intervention for oncologists and patients with advanced cancer and their caregivers. At the time of study entry, patients and caregivers (141 dyads) were categorized as endorsing a ""good"" prognosis if they: 1) reported a >50% chance of surviving ≥2 years; or if they 2) predicted that the patient's quality of life 3 months into the future would be ≥7 on an 11-point scale.
RESULTS


Approximately one-fifth of dyads agreed on a poor prognosis whereas approximately one-half disagreed regarding prognosis. In approximately one-third of dyads, patients and caregivers both believed the patient's future quality of life would be good (34%) and that the patient would live for ≥2 years (30%). Patients in these dyads were less likely to enroll in hospice compared with patients in dyads who disagreed and those who agreed on a shorter life expectancy and poor future quality of life.
CONCLUSIONS


Dyadic understanding of patients' projected life expectancy and future quality of life appears to be predictive of care received at the end of life. Improving rates of hospice enrollment may be best achieved with dyadic interventions.",2019,"Patients in these dyads were less likely to enroll in hospice compared with patients in dyads who disagreed and those who agreed on a shorter life expectancy and poor future quality of life.
","['Patients with advanced, incurable cancer', 'oncologists and patients with advanced cancer and their caregivers']",['communication intervention'],"['life expectancy and future quality of life', 'life expectancy and poor future quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}]","[{'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0034380'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}]",,0.12627,"Patients in these dyads were less likely to enroll in hospice compared with patients in dyads who disagreed and those who agreed on a shorter life expectancy and poor future quality of life.
","[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Trevino', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Holly G', 'Initials': 'HG', 'LastName': 'Prigerson', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Megan Johnson', 'Initials': 'MJ', 'LastName': 'Shen', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': 'Department of Pediatrics, University of California at Davis, Davis, California.'}, {'ForeName': 'Guibo', 'Initials': 'G', 'LastName': 'Xing', 'Affiliation': 'Department of Pediatrics, University of California at Davis, Davis, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoerger', 'Affiliation': 'Department of Psychology, Tulane University, New Orleans, Louisiana.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, New York.'}]",Cancer,['10.1002/cncr.32188']
1432,31134657,"Effects of Ketoconazole, a CYP4F2 Inhibitor, and CYP4F2*3 Genetic Polymorphism on Pharmacokinetics of Vitamin K 1 .","The objective of this study was to evaluate whether cytochrome P450 (CYP)4F2 is involved in the exposure of vitamin K 1  through a drug interaction study with ketoconazole, a CYP4F2 inhibitor, and a pharmacogenetic study with CYP4F2*3. Twenty-one participants with different CYP4F2*3 polymorphisms were enrolled (8 for *1/*1, 7 for *1/*3, and 6 for *3/*3). All participants were treated twice daily for 5 days with 200 mg of ketoconazole or placebo. Finally, a single dose of 10 mg vitamin K 1  was administered, plasma levels of vitamin K 1  were measured, and its pharmacokinetics was assessed. Ketoconazole elevated the plasma levels of vitamin K 1  and increased the average area under the concentration-time curve (AUC inf  ) and peak concentration by 41% and 40%, respectively. CYP4F2*3 polymorphism also affected plasma levels of vitamin K 1  and its pharmacokinetics in a gene dose-dependent manner. The average AUC inf  value was 659.8 ng·h/mL for CYP4F2*1/*1, 878.1 ng·h/mL for CYP4F2*1/*3, and 1125.2 ng·h/mL for CYP4F2*3/*3 (P = .010). This study revealed that ketoconazole and CYP4F2*3 polymorphism substantially increased the exposure of vitamin K 1  in humans. These findings provide a plausible explanation for variations in warfarin dose requirements resulting from interindividual variations in vitamin K 1  exposure due to CYP4F2-related drug interactions and genetic polymorphisms.",2019,"Ketoconazole elevated the plasma levels of vitamin K 1  and increased the average area under the concentration-time curve (AUC inf  ) and peak concentration by 41% and 40%, respectively.","['Twenty-one participants with different CYP4F2*3 polymorphisms were enrolled (8 for *1/*1, 7 for *1/*3, and 6 for *3/*3']","['cytochrome P450 (CYP)4F2', 'ketoconazole or placebo', 'Ketoconazole', 'ketoconazole']","['plasma levels of vitamin K 1  and increased the average area under the concentration-time curve (AUC inf  ) and peak concentration', 'average AUC inf  value', 'plasma levels of vitamin K 1']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}]","[{'cui': 'C0010762', 'cui_str': 'Cytochrome P-450 Families'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031862', 'cui_str': 'phytonadione'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",21.0,0.276542,"Ketoconazole elevated the plasma levels of vitamin K 1  and increased the average area under the concentration-time curve (AUC inf  ) and peak concentration by 41% and 40%, respectively.","[{'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, Anam Hospital, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyoung-Ah', 'Initials': 'KA', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, Anam Hospital, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, Anam Hospital, Korea University College of Medicine, Seoul, South Korea.'}]",Journal of clinical pharmacology,['10.1002/jcph.1444']
1433,31160472,Immersive Virtual Reality for Pediatric Procedural Pain: A Randomized Clinical Trial.,"BACKGROUND AND OBJECTIVES


Pain management in children often is inadequate, and the single most common painful procedure in children who are hospitalized is needle procedures. Virtual reality (VR) is a promising and engaging intervention that may help to decrease anxiety and pain in children undergoing painful procedures. Our aim for this study is to investigate patient satisfaction and pain reduction by using a three-dimensional VR interactive game as a distraction.
METHODS


In this randomized clinical trial, we enrolled 64 children aged 7 to 16 years who were scheduled for venous cannulation. Patients assigned to the control group were adherent to our standard of care, including topical numbing cream, positioning, and distraction by a specialized pain nurse. In the study group, children were adherent to the standard of care and were distracted by an interactive VR game. Primary outcomes were patient satisfaction and the procedural pain assessed by using a visual analog score; secondary outcomes were the procedural time and any adverse events.
RESULTS


We found a high level of patient satisfaction with using the VR custom-made three-dimensional interactive game. All children (28 of 28 [100%]) in the VR group answered that they would prefer VR as a distraction for a later procedure, a borderline significant result compared with that of the control group (26 of 31 [84.9%]). No significant difference was found in pain scores and procedural times between the 2 groups. The number of adverse effects was low, with no significant difference between the 2 groups.
CONCLUSIONS


We found no difference in pain scores but higher satisfaction when using VR versus standard care as part of a multimodal approach for management of procedural pain in children.",2019,We found no difference in pain scores but higher satisfaction when using VR versus standard care as part of a multimodal approach for management of procedural pain in children.,"['Pediatric Procedural Pain', '64 children aged 7 to 16 years who were scheduled for venous cannulation', 'children undergoing painful procedures']","['topical numbing cream, positioning, and distraction by a specialized pain nurse', 'Virtual reality (VR', 'Immersive Virtual Reality']","['patient satisfaction and pain reduction', 'patient satisfaction and the procedural pain assessed by using a visual analog score; secondary outcomes were the procedural time and any adverse events', 'number of adverse effects', 'pain scores', 'pain scores and procedural times', 'anxiety and pain']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1619712', 'cui_str': 'Pain, Procedural'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1619712', 'cui_str': 'Pain, Procedural'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",64.0,0.0995568,We found no difference in pain scores but higher satisfaction when using VR versus standard care as part of a multimodal approach for management of procedural pain in children.,"[{'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Walther-Larsen', 'Affiliation': 'The Pediatric Pain Clinic, Juliane Marie Centre, Rigshospitalet, Copenhagen, Denmark soeren.walther-larsen@regionh.dk.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Petersen', 'Affiliation': 'The Pediatric Pain Clinic, Juliane Marie Centre, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Friis', 'Affiliation': 'The Pediatric Pain Clinic, Juliane Marie Centre, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Gitte', 'Initials': 'G', 'LastName': 'Aagaard', 'Affiliation': 'The Pediatric Pain Clinic, Juliane Marie Centre, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Bergitte', 'Initials': 'B', 'LastName': 'Drivenes', 'Affiliation': 'The Pediatric Pain Clinic, Juliane Marie Centre, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Opstrup', 'Affiliation': 'The Pediatric Pain Clinic, Juliane Marie Centre, Rigshospitalet, Copenhagen, Denmark.'}]",Hospital pediatrics,['10.1542/hpeds.2018-0249']
1434,31162757,The effects of bladder training on bladder functions after transurethral resection of prostate.,"AIM AND OBJECTIVES


The aim of this was to examine the effect of bladder training on bladder functions.
BACKGROUND


Urinary catheterization is frequently performed in order to evaluate the outcomes of the surgical procedures and to monitor the urine output after urology operations.
DESIGN AND METHODS


This quasi-experimental study was conducted in the urology clinic in Istanbul, Turkey in which 50 males were nonrandomly assigned to either a bladder training (n = 28) or a control group (n =22). In the bladder training groups, the urinary catheters of the patients were clamped at 4-hr intervals and then were left open for 5 min on the second postoperative day. This study was created in accordance with TREND Statement Checklist.
RESULTS


The first urgency time and the first voiding time were longer, and the prevoiding and the voiding volumes were higher following the removal of the catheter in the training group (p = 0.001). In addition, the evaluation of the patient bladder diaries in the first three days after the discharge period revealed that the daily frequencies of micturition and nocturia were lower (p = 0.04), the mean duration of intervals between the micturition was longer (p = 0.006), and the mean voided urinary volume was higher (p = 0.024) in the training group.
CONCLUSION


At the end of the study, it is observed that bladder training performed by clamping the catheter on postoperative day 2 after Transurethral Resection of Prostate (TUR-P) operation is a significant positive effect on the storage symptoms of the patients.
RELEVANCE TO CLINICAL PRACTICE


Before removing the urinary catheter, bladder training programme affects positively to patients, especially prevoiding and the voiding volumes, the daily frequencies of micturition and nocturia on postoperative periods.",2020,"The first urgency time and the first voiding time were longer, and the prevoiding and the voiding volumes were higher following the removal of the catheter in the training group (p = 0.001).","['after transurethral resection of prostate', 'urology clinic in Istanbul, Turkey in which 50 males']",['bladder training'],"['urgency time and the first voiding time', 'daily frequencies of micturition and nocturia', 'patient bladder diaries', 'mean voided urinary volume', 'mean duration of intervals between the micturition', 'bladder functions', 'voiding volumes']","[{'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C3812395', 'cui_str': 'Urology clinic'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0150474', 'cui_str': 'Urinary bladder training'}]","[{'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination (finding)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0232840', 'cui_str': 'Bladder function (observable entity)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",50.0,0.0245313,"The first urgency time and the first voiding time were longer, and the prevoiding and the voiding volumes were higher following the removal of the catheter in the training group (p = 0.001).","[{'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Büyükyilmaz', 'Affiliation': 'Fundamentals of Nursing Department, Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing, Istanbul, Turkey.'}, {'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Culha', 'Affiliation': 'Fundamentals of Nursing Department, Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing, Istanbul, Turkey.'}, {'ForeName': 'Hande', 'Initials': 'H', 'LastName': 'Zümreler', 'Affiliation': 'Department of Urology, University of Health Sciences, Okmeydanı Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Özer', 'Affiliation': 'Department of Urology, University of Health Sciences, Okmeydanı Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet Gokhan', 'Initials': 'MG', 'LastName': 'Culha', 'Affiliation': 'Department of Urology, University of Health Sciences, Okmeydanı Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Ötünçtemur', 'Affiliation': 'Department of Urology, University of Health Sciences, Okmeydanı Training and Research Hospital, Istanbul, Turkey.'}]",Journal of clinical nursing,['10.1111/jocn.14939']
1435,31051248,Telephone call reminders did not increase screening uptake more than SMS reminders: a recruitment study within a trial.,"OBJECTIVES


The aim of the study was to compare the response rates and costs of phone call vs. short message service (SMS) screening reminders to prospective randomized controlled trial (RCT) participants.
STUDY DESIGN AND SETTING


This study was a randomized evaluation within a large Australian diabetes prevention RCT. Participants were men aged 50-74 years, overweight or obese, without a previous type 2 diabetes diagnosis. Those eligible on a prescreening questionnaire who did not attend a further screening assessment within 4 weeks were randomized to receive an SMS or phone call reminder (N = 709). The primary outcome was attendance for further screening assessment within 8 weeks of prescreening.
RESULTS


Attendance was 18% (62/354) in the SMS reminder group, and 23% (80/355) in the phone reminder group, with no statistically significant difference in response according to reminder type (relative risk = 1.29, 95% confidence interval [CI]: 0.96-1.73, P = 0.09). The lower confidence limits for response to SMS (95% CI: 14-22%) and phone reminders (95% CI: 18-27%) did not include the 8-week attendance rate before this evaluation, 12%. Phone reminders cost substantially more than SMS reminders (AU$6.21 vs. AU$0.53 per reminder).
CONCLUSION


SMS reminders were as adequate a method as phone reminders to boost RCT screening uptake and were considerably more affordable.",2019,"Phone reminders cost substantially more than SMS reminders (AU$6.21 vs. AU$0.53 per reminder).
","['Participants were men aged 50-74\xa0years, overweight or obese, without a previous type 2 diabetes diagnosis', 'Those eligible on a prescreening questionnaire who did not attend a further screening assessment within 4\xa0weeks']","['phone call vs. short message service (SMS) screening reminders', 'Telephone call reminders', 'SMS or phone call reminder']","['attendance for further screening assessment within 8\xa0weeks of prescreening', '8-week attendance rate', 'screening uptake']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0559294', 'cui_str': 'Not attended'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3178909'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",,0.322478,"Phone reminders cost substantially more than SMS reminders (AU$6.21 vs. AU$0.53 per reminder).
","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bracken', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia. Electronic address: karen.bracken@ctc.usyd.edu.au.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Keech', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hague', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Kirby', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kristy P', 'Initials': 'KP', 'LastName': 'Robledo', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Allan', 'Affiliation': 'Department of Clinical Research, Hudson Institute of Medical Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Conway', 'Affiliation': 'Anzac Research Institute and Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Daniel', 'Affiliation': 'Health Research Institute, University of Canberra, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mathis', 'Initials': 'M', 'LastName': 'Grossmann', 'Affiliation': 'Department of Medicine, The Austin Hospital, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Handelsman', 'Affiliation': 'Anzac Research Institute and Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Warrick', 'Initials': 'W', 'LastName': 'Inder', 'Affiliation': 'Department of Diabetes and Endocrinology, Princess Alexandra Hospital, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Jenkins', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Department of Clinical Research, Hudson Institute of Medical Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Stuckey', 'Affiliation': 'Keogh Institute of Medical Research and Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Bu B', 'Initials': 'BB', 'LastName': 'Yeap', 'Affiliation': 'Department of Endocrinology and Diabetes, Fiona Stanley Hospital and Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wittert', 'Affiliation': 'Freemasons Foundation Centre for Mens Health, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.04.009']
1436,31103365,Therapeutic HSV-2 vaccine decreases recurrent virus shedding and recurrent genital herpes disease.,"BACKGROUND


Genital herpes simplex virus (HSV) type 2 is a common persistent infection that frequently reactivates to cause recurrent lesions and recurrent viral shedding which is incompletely controlled by antiviral therapy. GEN-003 is a candidate therapeutic vaccine containing 2 HSV-2 proteins, gD2 and ICP4, and Matrix-M2 adjuvant (M2).
METHODS


HSV-2 seropositive persons with genital herpes were randomized into three dose cohorts of Gen-003 (60 µg antigen/50 µg M2, 60 µg/75 µg M2 or Placebo). Three intramuscular doses 21 days apart of GEN-003 or placebo were administered. Participants obtained genital area swabs twice-daily for HSV-2 detection and monitored genital lesions for 12 months. The rates of virus shedding and lesion rates before vaccination were compared to 3 defined periods after vaccination; Days 43-71, Month 6 and Month 12.
RESULTS


GEN-003 at a dose of 60 µg each antigen/50 µg M2 reduced HSV shedding immediately after dosing with a rate ratio of 0.58, compared to 0.75 for the GEN-003 60 µg/75 µg M2 and 1.06 for placebo. Lesion rates, recurrence rates, and duration of recurrences were also reduced. Reactogenicity was higher with the 75 µg M2 dose than the 50 µg M2 dose, specifically for pain, tenderness, malaise and fatigue. Antibody and cellular immune responses were stimulated by both doses and persisted to 12 months.
CONCLUSIONS


GEN-003 vaccine manufactured with a scalable process gave results similar to those observed in prior clinical trials. GEN-003 had an acceptable safety profile and stimulated both humoral and cellular immune responses. The 60 µg antigen/50 µg M2 provided the maximal effect on virologic and clinical measures and warrants further development. (Funded by Genocea; ClinicalTrials.gov number NCT02515175).",2019,"Reactogenicity was higher with the 75 µg M2 dose than the 50 µg M2 dose, specifically for pain, tenderness, malaise and fatigue.",['HSV-2 seropositive persons with genital herpes'],"['placebo', 'Gen-003 (60\u202fµg antigen/50\u202fµg\u202fM2, 60\u202fµg/75\u202fµg\u202fM2 or Placebo', 'GEN-003', 'GEN-003 or placebo', 'Therapeutic HSV-2 vaccine']","['Lesion rates, recurrence rates, and duration of recurrences', 'rates of virus shedding and lesion rates', 'Reactogenicity', 'Antibody and cellular immune responses', 'pain, tenderness, malaise and fatigue']","[{'cui': 'C0019351', 'cui_str': 'Human Herpesvirus 2'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019342', 'cui_str': 'Herpes Simplex Virus Genital Infection'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521767', 'cui_str': 'US Military Commissioned Officer O10'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019351', 'cui_str': 'Human Herpesvirus 2'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0024528', 'cui_str': 'Malaise and fatigue (finding)'}]",,0.0722721,"Reactogenicity was higher with the 75 µg M2 dose than the 50 µg M2 dose, specifically for pain, tenderness, malaise and fatigue.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Bernstein', 'Affiliation': ""Cincinnati Children's Hospital Medzical Center, University of Cincinnati, Cincinnati, OH, USA. Electronic address: david.bernstein@cchmc.org.""}, {'ForeName': 'Jessica B', 'Initials': 'JB', 'LastName': 'Flechtner', 'Affiliation': 'Genocea Biosciences, Cambridge, MA, USA.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'McNeil', 'Affiliation': 'Genocea Biosciences, Cambridge, MA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heineman', 'Affiliation': 'Genocea Biosciences, Cambridge, MA, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Oliphant', 'Affiliation': 'Innovative Analytics, Kalamazoo, MI, USA.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Tasker', 'Affiliation': 'Genocea Biosciences, Cambridge, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wald', 'Affiliation': 'University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Hetherington', 'Affiliation': 'Genocea Biosciences, Cambridge, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2019.05.009']
1437,31103367,Effectiveness of a multimodal intervention to increase vaccination in obstetrics/gynecology settings.,"OBJECTIVE


To test the effectiveness of a multimodal intervention in obstetrics/gynecology (ob-gyn) clinics to increase uptake of influenza and tetanus-diphtheria-acellular pertussis (Tdap) vaccines in pregnant women and these vaccines plus human papillomavirus (HPV) vaccine in non-pregnant women.
METHODS


A cluster randomized controlled trial among 9 private ob-gyn practices in Colorado from 9/2011 to 5/2014. The intervention consisted of: designation of immunization champions, staff/provider trainings, assistance with vaccine purchasing/management, identification of eligible patients, standing order implementation, chart review/feedback, and patient education materials. Control practices continued usual care. Primary outcomes were receipt of influenza and Tdap vaccines among pregnant women and these vaccines plus HPV vaccine among non-pregnant women, comparing a Baseline period (Year 0/Year 1) to Year 2, intervention versus control. With an estimated sample size of 32,590 per arm, there would be >80% power to detect a 10% difference between groups.
RESULTS


In the Baseline period, 27% of pregnant women in both intervention and control practices received influenza vaccine. In Year 2, 29% of pregnant women in intervention practices received influenza vaccine versus 41% in control practices. In the Baseline period, 18% of pregnant women in intervention practices received Tdap vaccine versus 22% in control practices. Both intervention and control practices increased to 51% in Year 2, representing an increase of 33% for intervention practices and 29% for control practices, consistent with a change in Tdap recommendations. Relatively few HPV, influenza or Tdap vaccines (≤6% of eligible patients) were given to non-pregnant patients in either intervention or control practices at any time during the study.
CONCLUSION


In this cluster randomized trial designed to increase vaccination uptake, both intervention and control practices showed improved vaccination of pregnant but not non-pregnant patients. Future work should focus on tailoring evidence-based immunization practices or developing new approaches to specifically fit busy ob-gyn offices.",2019,"Both intervention and control practices increased to 51% in Year 2, representing an increase of 33% for intervention practices and 29% for control practices, consistent with a change in Tdap recommendations.","['pregnant women and these', 'obstetrics/gynecology settings', 'non-pregnant women', 'pregnant but not non-pregnant patients', '9 private ob-gyn practices in Colorado from 9/2011 to 5/2014']","['Tdap vaccines', 'Tdap vaccine', 'vaccines plus human papillomavirus (HPV) vaccine', 'immunization champions, staff/provider trainings, assistance with vaccine purchasing/management, identification of eligible patients, standing order implementation, chart review/feedback, and patient education materials', 'diphtheria-acellular pertussis (Tdap) vaccines', 'influenza vaccine', 'multimodal intervention']",['receipt of influenza and Tdap vaccines'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4277736', 'cui_str': 'Standing Orders'}, {'cui': 'C0541653', 'cui_str': 'Chart review'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]",9.0,0.0895034,"Both intervention and control practices increased to 51% in Year 2, representing an increase of 33% for intervention practices and 29% for control practices, consistent with a change in Tdap recommendations.","[{'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA; Department of Pediatrics, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA. Electronic address: sean.oleary@ucdenver.edu.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA.""}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Brewer', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA.""}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Sevick', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Miriam Dickinson', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA; Department of Family Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA.""}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA; Department of Pediatrics, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA.""}]",Vaccine,['10.1016/j.vaccine.2019.05.034']
1438,28866911,Cognitive-Behavioral Therapy for Adult ADHD: A Randomized Clinical Trial in China.,"OBJECTIVE


Cognitive-behavioral therapy (CBT) is effective for adult ADHD, and booster sessions may improve long-term outcome. This study was designed to investigate the effects of group CBT and its booster sessions for Chinese adult patients with ADHD.
METHOD


There were CBT only group ( n = 43), CBT +booster group ( n = 43), and control group with patients on the waiting list ( n = 22). The primary outcome was the score of the ADHD-Rating Scale (ADHD-RS). Secondary outcomes included emotion, executive function (EF), impulsivity, self-esteem, and life quality at 12th and 24th week.
RESULTS


At 12th week, the score of ADHD-RS, EF, and impulsivity showed significant improvement in CBT +booster group comparing with control group. At 24th week, differences between CBT only group and CBT +booster group were not significant.
CONCLUSION


CBT was effective for Chinese adult patients with ADHD. Booster sessions do not appear to provide additional benefits.",2019,"At 12th week, the score of ADHD-RS, EF, and impulsivity showed significant improvement in CBT +booster group comparing with control group.","['Chinese adult patients with ADHD', 'Adult ADHD']","['CBT', 'Cognitive-behavioral therapy (CBT', 'Cognitive-Behavioral Therapy']","['score of ADHD-RS, EF, and impulsivity', 'score of the ADHD-Rating Scale (ADHD-RS', 'emotion, executive function (EF), impulsivity, self-esteem, and life quality at 12th and 24th week']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0222045'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0034380'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",43.0,0.0298164,"At 12th week, the score of ADHD-RS, EF, and impulsivity showed significant improvement in CBT +booster group comparing with control group.","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': '1 Peking University Sixth Hospital/Institute of Mental Health, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Yi-Lang', 'Initials': 'YL', 'LastName': 'Tang', 'Affiliation': '3 Emory University, School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Mengjie', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': '1 Peking University Sixth Hospital/Institute of Mental Health, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Yanfei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': '1 Peking University Sixth Hospital/Institute of Mental Health, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Meirong', 'Initials': 'M', 'LastName': 'Pan', 'Affiliation': '1 Peking University Sixth Hospital/Institute of Mental Health, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': '1 Peking University Sixth Hospital/Institute of Mental Health, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Qiujin', 'Initials': 'Q', 'LastName': 'Qian', 'Affiliation': '1 Peking University Sixth Hospital/Institute of Mental Health, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}]",Journal of attention disorders,['10.1177/1087054717725874']
1439,31669450,Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs: The HERO study.,"BACKGROUND


Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) - results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection.
METHODS


The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT.
CONCLUSIONS


This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.",2019,"Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk.","['eight states where 754 HCV-infected PWID', 'people who inject drugs']","['direct-acting antiviral agents (DAAs', 'hepatitis C treatment', 'two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) ', 'PN or mDOT']","['failure to achieve SVR, DAA resistance, and HCV reinfection', 'virologic response (SVR) rates']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0003451', 'cui_str': 'Antiviral Drugs'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205339', 'cui_str': 'Reinfection (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}]",,0.0854155,"Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk.","[{'ForeName': 'Alain H', 'Initials': 'AH', 'LastName': 'Litwin', 'Affiliation': 'Clemson University School of Health Research, Clemson, SC, USA; Department of Medicine, University of South Carolina School of Medicine, Greenville, SC, USA; Department of Medicine, Prisma Health, Greenville, SC, USA. Electronic address: Alain.Litwin@prismahealth.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jost', 'Affiliation': 'Department of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Wagner', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Department of Public Health Sciences, College of Behavioral, Social, and Health Sciences, Clemson University Clemson, SC, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Karasz', 'Affiliation': 'Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Feinberg', 'Affiliation': 'Department of Behavioral Medicine & Psychiatry and Department of Medicine, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Arthur Y', 'Initials': 'AY', 'LastName': 'Kim', 'Affiliation': 'Department of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Lum', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Shruti H', 'Initials': 'SH', 'LastName': 'Mehta', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Taylor', 'Affiliation': 'College of Pharmacy, University of Rhode Island, CODAC Behavioral Health, Providence, RI, USA.'}, {'ForeName': 'Judith I', 'Initials': 'JI', 'LastName': 'Tsui', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Pericot-Valverde', 'Affiliation': 'Clemson University School of Health Research, Clemson, SC, USA; Department of Medicine, Prisma Health, Greenville, SC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2019.105859']
1440,31125609,Who Hurts More? A Multicenter Prospective Study of In-Hospital Opioid Use in Pediatric Trauma Patients in the Midwest.,"BACKGROUND


Despite increased national attention on misuse of prescription and nonprescription opioids for adolescents and children, little is known about opioid use in a pediatric population during hospitalization for injury. The purpose of this investigation is to describe opioid administration and magnitude of opioid exposure in the first 48 hours of hospitalization in a pediatric trauma population.
STUDY DESIGN


This is a secondary analysis of data collected for a randomized, prospective intervention study at 4 Midwestern children's trauma centers. Participants included children ages 10 to 17 years old, admitted to the hospital for unintentional injury. Descriptive statistics and multivariable modeling were used to characterize demographic factors and measure prevalence and magnitude of opioid use within the first 48 hours of hospitalization.
RESULTS


Among 299 participants, 82% received at least 1 opioid administration. Children had increased odds of receiving an opioid (odds ratio [OR] 4.25; 95% CI 2.16 to 8.35) for every log increase of Injury Severity Scores (ISS), yet the majority of children with minor injury (61%) also received an opioid. Children with fractures and older children had higher odds of receiving an opioid. Amount of opioid, expressed as morphine milligrams equivalent (MME), significantly increased with child age, ISS, and fracture.
CONCLUSIONS


Most pediatric trauma patients received an opioid in the first 48 hours of hospitalization, although prevalence and exposure varied by age, injury, and acuity. Aggressive pain management can be appropriate for injured pediatric patients; however, study results indicate areas for improvement, specifically for children with minor injuries and those receiving excessive opioid amounts.",2019,"Children had increased odds of receiving an opioid (odds ratio [OR] 4.25; 95% CI 2.16 to 8.35) for every log increase of Injury Severity Scores (ISS), yet the majority of children with minor injury (61%) also received an opioid.","['pediatric trauma patients', 'Pediatric Trauma Patients in the Midwest', 'Children with fractures and older children', 'adolescents and children', 'Participants included children ages 10 to 17 years old, admitted to the hospital for unintentional injury', 'injured pediatric patients', ""4 Midwestern children's trauma centers"", '299 participants, 82% received at least 1 opioid administration', 'first 48 hours of hospitalization in a pediatric trauma population']",[],['Injury Severity Scores (ISS'],"[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0021504', 'cui_str': 'ISS Score'}]",4.0,0.0322579,"Children had increased odds of receiving an opioid (odds ratio [OR] 4.25; 95% CI 2.16 to 8.35) for every log increase of Injury Severity Scores (ISS), yet the majority of children with minor injury (61%) also received an opioid.","[{'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Pelaez', 'Affiliation': 'Trauma Surgery, Iowa Clinic, Des Moines, IA; Trauma Services, UnityPoint Health, Des Moines, IA.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Davis', 'Affiliation': 'Injury Prevention Research Center, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Spilman', 'Affiliation': 'Trauma Services, UnityPoint Health, Des Moines, IA. Electronic address: sarah.spilman@unitypoint.org.'}, {'ForeName': 'Hope M', 'Initials': 'HM', 'LastName': 'Guzzo', 'Affiliation': 'Trauma Services, UnityPoint Health, Des Moines, IA; General Surgery, Iowa Methodist Medical Center, Des Moines, IA.'}, {'ForeName': 'Kristel M', 'Initials': 'KM', 'LastName': 'Wetjen', 'Affiliation': ""Pediatric Trauma Program, University of Iowa Stead Family Children's Hospital, Iowa City, IA.""}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Randell', 'Affiliation': ""Pediatric Emergency Medicine, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Ortega', 'Affiliation': ""Pediatric Emergency Medicine, Children's Minnesota, Minneapolis, MN.""}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Pitcher', 'Affiliation': ""Pediatric Surgery, University of Iowa Stead Family Children's Hospital, Iowa City, IA.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Kenardy', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Marizen R', 'Initials': 'MR', 'LastName': 'Ramirez', 'Affiliation': 'Injury Prevention Research Center, University of Iowa, Iowa City, IA; Division of Environmental Health Sciences, University of Minnesota, Minneapolis, MN.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2019.05.021']
1441,31747846,"The Efficacy of a Resilience Intervention Among Diverse, At-Risk, College Athletes: A Mixed-Methods Study.","BACKGROUND:  Adverse childhood experiences (ACEs) have been associated with psychological and physiological disease, and risky health behaviors. A person's ability to be resilient may protect them from these negative health outcomes, as resilience has been associated with increased emotional awareness, coping, belonging, and greater likelihood of good health and well-being.  AIMS:  The purpose of this pilot study was to assess the efficacy of a strengths-based resilience intervention to improve access to internal and external resources that effect perceptions of stress, resilience, emotional awareness, and belonging among student-athletes.  METHODS:  A mixed-methods design was used to examine variables of interest between intervention and control groups. A sample of 56 college athletes completed surveys and engaged in expressive writing during a 5-week resilience intervention.  RESULTS:  Self-report data indicated that student-athletes in the intervention group improved decision making, lowered perceived stress, and increased resilience compared with controls. Of note, participants with ACEs showed greater increments of positive change in emotional awareness scales than participants without ACEs. Descriptions of emotion management, authentic connections, and increased ability to request support from others were identified in the qualitative data.  CONCLUSIONS:  A strengths-based course designed to increase resilience-offered as academic and athletic stress is mounting-provided a unique opportunity to promote student-athlete success. Participants gained skills key to victory on and off the field, including health-promoting behaviors, a sense of belonging, persistence, and the ability to negotiate external resources.",2020,"Self-report data indicated that student-athletes in the intervention group improved decision making, lowered perceived stress, and increased resilience compared with controls.","['Diverse, At-Risk, College Athletes', '56 college athletes completed surveys and engaged in expressive writing during a 5-week resilience intervention']",['strengths-based resilience intervention'],['positive change in emotional awareness scales'],"[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0222045'}]",,0.034505,"Self-report data indicated that student-athletes in the intervention group improved decision making, lowered perceived stress, and increased resilience compared with controls.","[{'ForeName': 'Genevieve E', 'Initials': 'GE', 'LastName': 'Chandler', 'Affiliation': 'Genevieve E. Chandler, PhD, RN, University of Massachusetts Amherst, MA, USA.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Kalmakis', 'Affiliation': 'Karen A. Kalmakis, PhD, MPH, FNP, FAANP, University of Massachusetts Amherst, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Chiodo', 'Affiliation': 'Lisa Chiodo, PhD, University of Massachusetts Amherst, MA, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Helling', 'Affiliation': 'Jim Helling, LICSW, University of Massachusetts Amherst, MA, USA.'}]",Journal of the American Psychiatric Nurses Association,['10.1177/1078390319886923']
1442,31748300,HOMESIDE: home-based family caregiver-delivered music and reading interventions for people living with dementia: protocol of a randomised controlled trial.,"INTRODUCTION


Pharmacological interventions to address behavioural and psychological symptoms of dementia (BPSD) can have undesirable side effects, therefore non-pharmacological approaches to managing symptoms may be preferable. Past studies show that music therapy can reduce BPSD, and other studies have explored how formal caregivers use music in their caring roles. However, no randomised study has examined the effects on BPSD of music interventions delivered by informal caregivers (CGs) in the home setting. Our project aims to address the need for improved informal care by training cohabiting family CGs to implement music interventions that target BPSD, and the quality of life (QoL) and well-being of people with dementia (PwD) and CGs.
METHODS AND ANALYSIS


A large international three-arm parallel-group randomised controlled trial will recruit a sample of 495 dyads from Australia, Germany, UK, Poland and Norway. Dyads will be randomised equally to standard care (SC), a home-based music programme plus SC, or a home-based reading programme plus SC for 12 weeks. The primary outcome is BPSD of PwD (measured using the Neuropsychiatric Inventory-Questionnaire). Secondary outcomes will examine relationship quality between CG and PwD, depression, resilience, competence, QoL for CG and QoL for PwD. Outcomes will be collected at baseline, at the end of the 12-week intervention and at 6 months post randomisation. Resource Utilisation in Dementia will be used to collect economic data across the life of the intervention and at 6-month follow-up. We hypothesise that the music programme plus SC will generate better results than SC alone (primary comparison) and the reading programme plus SC (secondary comparison).
ETHICS AND DISSEMINATION


Ethical approval has been obtained for all countries. Results will be presented at national and international conferences and published in scientific journals and disseminated to consumer and caregiver representatives and the community.
TRIAL REGISTRATION NUMBERS


ACTRN12618001799246p; NCT03907748.",2019,"Our project aims to address the need for improved informal care by training cohabiting family CGs to implement music interventions that target BPSD, and the quality of life (QoL) and well-being of people with dementia (PwD) and CGs.
","['495 dyads from Australia, Germany, UK, Poland and Norway', 'people living with dementia']","['home-based family caregiver-delivered music and reading interventions', 'standard care (SC), a home-based music programme plus SC, or a home-based reading programme plus SC', 'music therapy']","['BPSD of PwD (measured using the Neuropsychiatric Inventory-Questionnaire', 'relationship quality between CG and PwD, depression, resilience, competence, QoL for CG and QoL for PwD. Outcomes']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0026868', 'cui_str': 'Music Therapy'}]","[{'cui': 'C1868717', 'cui_str': 'BPSD'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",495.0,0.193686,"Our project aims to address the need for improved informal care by training cohabiting family CGs to implement music interventions that target BPSD, and the quality of life (QoL) and well-being of people with dementia (PwD) and CGs.
","[{'ForeName': 'Felicity Anne', 'Initials': 'FA', 'LastName': 'Baker', 'Affiliation': 'Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia felicity.baker@unimelb.edu.au.'}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Bloska', 'Affiliation': 'Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Braat', 'Affiliation': 'School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bukowska', 'Affiliation': 'Department of Occupational Therapy, University of Physical Education, Kraków, Poland.'}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Clark', 'Affiliation': 'Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ming H', 'Initials': 'MH', 'LastName': 'Hsu', 'Affiliation': 'Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Kvamme', 'Affiliation': 'Centre for Research in Music and Health, Norwegian Academy of Music, Oslo, Norway.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lautenschlager', 'Affiliation': 'Department of Psychiatry, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Young-Eun Claire', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Smrokowska-Reichmann', 'Affiliation': 'Department of Occupational Therapy, University of Physical Education, Kraków, Poland.'}, {'ForeName': 'Tanara Vieira', 'Initials': 'TV', 'LastName': 'Sousa', 'Affiliation': 'School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Karette A', 'Initials': 'KA', 'LastName': 'Stensaeth', 'Affiliation': 'Centre for Research in Music and Health, Norwegian Academy of Music, Oslo, Norway.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Tamplin', 'Affiliation': 'Faculty of Fine Arts and Music, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wosch', 'Affiliation': 'Hochschule für angewandte Wissenschaften Würzburg-Schweinfurt, Würzburg, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Odell-Miller', 'Affiliation': 'Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031332']
1443,31123862,Oral bovine colostrum supplementation does not increase circulating insulin-like growth factor-1 concentration in healthy adults: results from short- and long-term administration studies.,"PURPOSE


Bovine colostrum is available in health food shops and as a sports food supplement and is rich in antibodies and growth factors including IGF-1. World Anti-Doping Agency advises athletes against taking colostrum for fear of causing increased plasma IGF-1. There are also concerns that colostrum may theoretically stimulate malignancy in organs which express IGF-1 receptors. We, therefore, determined changes in plasma IGF-1 levels in subjects taking colostrum or placebo for 1 day, 4 weeks, and 12 weeks.
METHODS


Plasma IGF1 levels were determined in healthy males (n = 16) who ingested 40 g bovine colostrum or placebo along with undertaking moderate exercise for total period of 4.5 h. Two further studies followed changes in IGF1 using double-blind, parallel group, placebo-controlled, randomized trials of colostrum or placebo (N = 10 per arm, 20 g/day for 4 weeks and N = 25 colostrum, N = 29 placebo arm 20 g/day for 12 weeks).
RESULTS


Baseline IGF1 levels 130 ± 36 ng/ml. 4.5 h protocol showed no effect of colostrum on plasma IGF1 (ANOVA, treatment group: p = 0.400, group × time: p = 0.498, time p = 0.602). Similarly, no effect of colostrum ingestion was seen following 4 week (ANOVA, group: p = 0.584, group × time interaction: p = 0.083, time p = 0.243) or 12 week (ANOVA, group: p = 0.400, group × time interaction: p = 0.498, time p = 0.602) protocol.
CONCLUSIONS


Ingestion of standard recommended doses of colostrum does not increase IGF-1 levels in healthy adults, providing additional support for the safety profile of colostrum ingestion.",2020,"4.5 h protocol showed no effect of colostrum on plasma IGF1 (ANOVA, treatment group: p = 0.400, group × time: p = 0.498, time p = 0.602).","['healthy males (n\u2009=\u200916) who ingested 40\xa0g bovine colostrum or placebo along with undertaking moderate exercise for total period of 4.5\xa0h', 'healthy adults', 'subjects taking colostrum or']","['colostrum or placebo', 'Oral bovine colostrum supplementation', 'placebo']","['plasma IGF1', 'plasma IGF-1 levels', 'colostrum ingestion', 'circulating insulin-like growth factor-1 concentration', 'IGF-1 levels']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1278021', 'cui_str': 'Plasma IGF 1 measurement'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.327882,"4.5 h protocol showed no effect of colostrum on plasma IGF1 (ANOVA, treatment group: p = 0.400, group × time: p = 0.498, time p = 0.602).","[{'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Davison', 'Affiliation': 'School of Sport and Exercise Sciences, University of Kent at Medway, Chatham, UK.'}, {'ForeName': 'Arwel W', 'Initials': 'AW', 'LastName': 'Jones', 'Affiliation': 'Lincoln Institute for Health, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Marchbank', 'Affiliation': 'Centre for Immunobiology, Blizard Institute, Barts and The London School of Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Playford', 'Affiliation': 'Faculty of Medicine & Dentistry, University of Plymouth, Plymouth, UK. raymond.playford@plymouth.ac.uk.'}]",European journal of nutrition,['10.1007/s00394-019-02004-6']
1444,31748169,Long-term effects of intensive multifactorial therapy in individuals with screen-detected type 2 diabetes in primary care: 10-year follow-up of the ADDITION-Europe cluster-randomised trial.,"BACKGROUND


The multicentre, international ADDITION-Europe study investigated the effect of promoting intensive treatment of multiple risk factors among people with screen-detected type 2 diabetes over 5 years. Here we report the results of a post-hoc 10-year follow-up analysis of ADDITION-Europe to establish whether differences in treatment and cardiovascular risk factors have been maintained and to assess effects on cardiovascular outcomes.
METHODS


As previously described, general practices from four centres (Denmark, Cambridge [UK], Leicester [UK], and the Netherlands) were randomly assigned by computer-generated list to provide screening followed by routine care of diabetes, or screening followed by intensive multifactorial treatment. Population-based stepwise screening programmes among people aged 40-69 years (50-69 years in the Netherlands), between April, 2001, and December, 2006, identified patients with type 2 diabetes. Allocation was concealed from patients. Following the 5-year follow-up, no attempts were made to maintain differences in treatment between study groups. In this report, we did a post-hoc analysis of cardiovascular and renal outcomes over 10 years following randomisation, including a 5 years post-intervention follow-up. As in the original trial, the primary endpoint was a composite of first cardiovascular event, including cardiovascular mortality, cardiovascular morbidity (non-fatal myocardial infarction and non-fatal stroke), revascularisation, and non-traumatic amputation, up to Dec 31, 2014. Analyses were based on the intention-to-treat principle. ADDITION-Europe is registered with ClinicalTrials.gov, NCT00237549.
FINDINGS


343 general practices were randomly assigned to routine diabetes care (n=176) or intensive multifactorial treatment (n=167). 317 of these general practices (157 in the routine care group, 161 in the intensive treatment group) included eligible patients between April, 2001, and December, 2006. Of the 3233 individuals with screen-detected diabetes, 3057 agreed to participate (1379 in the routine care group, 1678 in the intensive treatment group), but at the 10-year follow-up 14 were lost to follow-up and 12 withdrew, leaving 3031 to enter 10-year follow-up analysis. Mean duration of follow-up was 9·61 years (SD 2·99). Sustained reductions over 10 years following diagnosis were apparent for bodyweight, HbA 1c , blood pressure, and cholesterol in both study groups, but between-group differences identified at 1 and 5 years were attenuated at the 10-year follow-up. By 10 years, 443 participants had a first cardiovascular event and 465 died. There was no significant difference between groups in the incidence of the primary composite outcome (16·1 per 1000 person-years in the routine care group vs 14·3 per 1000 person-years in the intensive treatment group; hazard ratio [HR] 0·87, 95% CI 0·73-1·04; p=0·14) or all-cause mortality (15·6 vs 14·3 per 1000 person-years; HR 0·90, 0·76-1·07).
INTERPRETATION


Sustained reductions in glycaemia and related cardiovascular risk factors over 10 years among people with screen-detected diabetes managed in primary care are achievable. The differences in prescribed treatment and cardiovascular risk factors in the 5 years following diagnosis were not maintained at 10 years, and the difference in cardiovascular events and mortality remained non-significant.
FUNDING


National Health Service Denmark, Danish Council for Strategic Research, Danish Research Foundation for General Practice, Novo Nordisk, Novo Nordisk Foundation, Danish Centre for Evaluation and Health Technology Assessment, Danish National Board of Health, Danish Medical Research Council, Aarhus University Research Foundation, Astra, Pfizer, GlaxoSmithKline, Servier, HemoCue, Wellcome Trust, UK Medical Research Council, UK National Institute for Health Research, UK National Health Service, Merck, Julius Center for Health Sciences and Primary Care, UK Department of Health, and Nuts-OHRA.",2019,"Sustained reductions over 10 years following diagnosis were apparent for bodyweight, HbA 1c , blood pressure, and cholesterol in both study groups, but between-group differences identified at 1 and 5 years were attenuated at the 10-year follow-up.","['people aged 40-69 years (50-69 years in the Netherlands), between April, 2001, and December, 2006, identified patients with type 2 diabetes', 'people with screen-detected type 2 diabetes over 5 years', '343 general practices', 'individuals with screen-detected type 2 diabetes in primary care', '3233 individuals with screen-detected diabetes, 3057 agreed to participate (1379 in the routine care group, 1678 in the intensive treatment group), but at the 10-year follow-up 14 were lost to follow-up and 12 withdrew, leaving 3031 to enter 10-year follow-up analysis', '443 participants had a first cardiovascular event and 465 died', 'As previously described, general practices from four centres (Denmark, Cambridge [UK], Leicester [UK], and the Netherlands', '317 of these general practices (157 in the routine care group, 161 in the intensive treatment group) included eligible patients between April, 2001, and December, 2006']","['routine diabetes care (n=176) or intensive multifactorial treatment', 'computer-generated list to provide screening followed by routine care of diabetes, or screening followed by intensive multifactorial treatment', 'intensive multifactorial therapy']","['Mean duration', 'cardiovascular risk factors', 'bodyweight, HbA 1c , blood pressure, and cholesterol', 'cardiovascular events and mortality', 'composite of first cardiovascular event, including cardiovascular mortality, cardiovascular morbidity (non-fatal myocardial infarction and non-fatal stroke), revascularisation, and non-traumatic amputation']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0002694', 'cui_str': 'Amputation, Traumatic'}]",443.0,0.0983433,"Sustained reductions over 10 years following diagnosis were apparent for bodyweight, HbA 1c , blood pressure, and cholesterol in both study groups, but between-group differences identified at 1 and 5 years were attenuated at the 10-year follow-up.","[{'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Primary Care Unit, Institute of Public Health, School of Clinical Medicine, University of Cambridge, Cambridge, UK. Electronic address: profgp@medschl.cam.ac.uk.'}, {'ForeName': 'Guy E H M', 'Initials': 'GEHM', 'LastName': 'Rutten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Witte', 'Affiliation': 'Section of Epidemiology, Aarhus University, Aarhus, Denmark; Department of Public Health, Aarhus University, Aarhus, Denmark; Danish Diabetes Academy, Odense, Denmark.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Lauritzen', 'Affiliation': 'Section for General Practice, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Else-Marie', 'Initials': 'EM', 'LastName': 'Dalsgaard', 'Affiliation': 'Section for General Practice, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Irving', 'Affiliation': 'Primary Care Unit, Institute of Public Health, School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Rimke C', 'Initials': 'RC', 'LastName': 'Vos', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, Netherlands; Department of Public Health and Primary Care, Leiden University Medical Center, Campus The Hague, The Hague, Netherlands.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Webb', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Wareham', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Annelli', 'Initials': 'A', 'LastName': 'Sandbæk', 'Affiliation': 'Section for General Practice, Aarhus University, Aarhus, Denmark; Steno Diabetes Center, Aarhus University Hospital, Aarhus, Denmark.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30349-3']
1445,31115257,Real-World Evidence of Prostatic Urethral Lift Confirms Pivotal Clinical Study Results: 2-Year Outcomes of a Retrospective Multicenter Study.,"Introduction:  This study expands results from recent prostatic urethral lift (PUL) clinical trials by examining outcomes within a large unconstrained multicenter data set.  Methods:  Retrospective chart review and analysis of 1413 consecutive patients who received PUL in North America and Australia was performed. International Prostate Symptom Score (IPSS), quality of life (QoL), and maximum urinary flow rate (Qmax) were evaluated at 1, 3, 6, 12, and 24 months post-procedure for all nonurinary retention subjects (Group A) and retention subjects (Group B). Within Group A outcomes were further analyzed using paired  t -tests and 95% mean confidence intervals under the following parameters: IPSS baseline ≥13, age, prostate size, site of service, prostate cancer treatment, and diabetic status. Adverse events, surgical interventions, and catheterization rates were summarized in detail.  Results:  Compared with the randomized controlled prosatic urethral lift (L.I.F.T.) study, subjects in this retrospective study were older and less symptomatic. After PUL, mean IPSS for Group A improved significantly from baseline by at least 8.1 points throughout follow-up. No significant differences were observed between Group A and B follow-up symptom scores. Within Group A, subjects with an IPSS baseline ≥13 behaved similarly to L.I.F.T. subjects. Age, prostate volume, site of service, prior cancer treatment, and diabetic status did not significantly affect PUL outcomes. When completed in a clinic office, PUL resulted in less side effects and catheter placement compared to other sites of service. Previous prostate cancer treatment did not elevate adverse events of high concern such as incontinence and infection.  Conclusion:  PUL performs well in a real-world setting in terms of symptom relief, morbidity, and patient experience for all studied patient cohorts.",2019,"PUL performs well in a real-world setting in terms of symptom relief, morbidity, and patient experience for all studied patient cohorts.","['1413 consecutive patients who received PUL in North America and Australia was performed', 'subjects with an IPSS baseline ≥13 behaved similarly to L.I.F.T. subjects']",['Prostatic Urethral Lift'],"['Adverse events, surgical interventions, and catheterization rates', 'Age, prostate volume, site of service, prior cancer treatment, and diabetic status', 'International Prostate Symptom Score (IPSS), quality of life (QoL), and maximum urinary flow rate (Qmax', 'side effects and catheter placement', 'prostate size, site of service, prostate cancer treatment, and diabetic status', 'mean IPSS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449197', 'cui_str': 'PUL (body structure)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C0181620', 'cui_str': 'Lift'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0034380'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate (observable entity)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}, {'cui': 'C0426731', 'cui_str': 'Prostate size'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",1413.0,0.0512722,"PUL performs well in a real-world setting in terms of symptom relief, morbidity, and patient experience for all studied patient cohorts.","[{'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Eure', 'Affiliation': '1 Urology of Virginia, Virginia Beach, Virginia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Gange', 'Affiliation': '2 Summit Urology Group, Salt Lake City, Utah.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Walter', 'Affiliation': '3 Western NY Urology Associates, Jamestown, New York.'}, {'ForeName': 'Ansar', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': '4 Urology Heath Center, Fremont, Nebraska.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chabert', 'Affiliation': '5 The Prostate Clinic, Benowa, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mueller', 'Affiliation': '6 Delaware Valley Urology, Voorhees, New Jersey.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cozzi', 'Affiliation': '7 Dr. Paul Cozzi, Hurstville, Australia.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': ""8 Advanced Urology & Women's Health Center, Elgin, South Carolina.""}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Freedman', 'Affiliation': '9 Sheldon Freedman, MD LTD, Las Vegas, Nevada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chin', 'Affiliation': '10 South Coast Urology, Wollongong, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Ochs', 'Affiliation': '11 Urology One, Canton, Ohio.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hirsh', 'Affiliation': '12 Jersey Urology Group, Somers, New Jersey.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trotter', 'Affiliation': '13 Midtown Urology Associates, Austin, Texas.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Grier', 'Affiliation': '14 Sound Urological Associates, Edmonds, Washington.'}]",Journal of endourology,['10.1089/end.2019.0167']
1446,30953333,"Roxadustat Treatment of Chronic Kidney Disease-Associated Anemia in Japanese Patients Not on Dialysis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial.","INTRODUCTION


This study evaluated efficacy and safety/tolerability of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, in Japanese anemic non-dialysis-dependent chronic kidney disease (NDD-CKD) patients.
METHODS


In this phase 2, double-blind, 24-week study, NDD-CKD patients were randomized to oral placebo or roxadustat (50, 70, or 100 mg) three times weekly (TIW) for 6 weeks followed by dose adjustments to maintain hemoglobin (Hb) at 10-12 g/dL for 18 weeks; patients meeting pre-defined criteria were re-randomized to TIW or once-weekly dosing. The primary end point was rate of rise of Hb (g/dL/week) during the first 6 weeks; secondary end points included response rate (Hb ≥ 10.0 g/dL and increase in Hb from baseline ≥ 1 g/dL) and mean Hb and change from baseline in Hb at weeks 18-24. The main safety outcomes were vital signs, laboratory test results, electrocardiograms, and frequency of treatment-emergent adverse events.
RESULTS


Of 107 patients randomized, 83 completed the study. The mean (SD) rate of rise of Hb during the first 6 weeks was - 0.052 (0.142) for placebo and + 0.200 (0.160), + 0.453 (0.256), and + 0.570 (0.240) for roxadustat 50-, 70-, and 100-mg TIW groups, respectively (p < 0.001). Response rate was 14.8% for placebo and 81.5%, 100%, and 100% for roxadustat TIW groups (p < 0.001). Change in Hb from baseline at weeks 18-24 was - 0.17 (0.61) for placebo and + 1.10 (0.71), + 1.33 (0.82), and + 1.55 (0.88) g/dL for roxadustat TIW groups (p < 0.001). No deaths or major adverse cardiac events occurred with roxadustat.
CONCLUSION


Roxadustat was well tolerated and effective in correcting Hb levels within 6 weeks in Japanese anemic NDD-CKD patients.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01964196. Registered 15 October 2013 (retrospectively registered).
FUNDING


Astellas Pharma Inc.",2019,"Response rate was 14.8% for placebo and 81.5%, 100%, and 100% for roxadustat TIW groups (p < 0.001).","['Registered 15 October 2013 (retrospectively registered', 'Japanese anemic non-dialysis-dependent chronic kidney disease (NDD-CKD) patients', 'Japanese Patients Not on Dialysis', 'NDD-CKD patients', 'Japanese anemic NDD-CKD patients', '107 patients randomized, 83 completed the study']","['Placebo', 'placebo', 'oral hypoxia-inducible factor prolyl hydroxylase inhibitor', 'oral placebo or roxadustat']","['rate of rise of Hb', 'tolerated and effective in correcting Hb levels', 'efficacy and safety/tolerability', 'mean (SD) rate of rise of Hb', 'deaths or major adverse cardiac events', 'response rate', 'Response rate', 'vital signs, laboratory test results, electrocardiograms, and frequency of treatment-emergent adverse events']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C3658210', 'cui_str': 'Proline Dioxygenase Inhibitors'}, {'cui': 'C4310578'}]","[{'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0518766'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test result'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",107.0,0.579934,"Response rate was 14.8% for placebo and 81.5%, 100%, and 100% for roxadustat TIW groups (p < 0.001).","[{'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Showa University School of Medicine, Namics 301, 4-24-51 Takanawa, Minato-ku, Tokyo, Japan. akizawa@med.showa-u.ac.jp.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Iwasaki', 'Affiliation': 'Yokohama City University School of Data Science, Yokohama, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Otsuka', 'Affiliation': 'Japan/Asia Clinical Development 2, Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Reusch', 'Affiliation': 'Medical Science Urology and Nephrology, Astellas Pharma Europe B.V., Leiden, The Netherlands.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Misumi', 'Affiliation': 'Japan-Asia Data Science, Astellas Pharma Inc., Tokyo, Japan.'}]",Advances in therapy,['10.1007/s12325-019-00943-4']
1447,30972657,Gender Effects in the Efficacy of Racemic Amphetamine Sulfate in Children with Attention-Deficit/Hyperactivity Disorder.,"INTRODUCTION


A laboratory classroom study in children aged 6-12 years with attention-deficit/hyperactivity disorder (ADHD) found that racemic amphetamine sulfate (RA-AMPH) significantly improved performance versus placebo from 45 min through 10 h post-dose (NCT01986062). A secondary analysis assessed gender as a potential moderator of response to treatment comparing the ADHD Rating Scale-IV (ADHD-RS-IV) and Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) rating scales.
METHODS


After 8 weeks of open-label RA-AMPH dose optimization using improvement in ADHD-RS-IV symptoms as a guide, 97 subjects (38 females and 59 males) were randomized to the sequence of 2 weeks of double-blind treatment with the optimized dose of RA-AMPH followed by placebo or vice versa during a laboratory classroom day. Efficacy measures included the SKAMP and the Permanent Product Measure of Performance (PERMP). The average difference for RA-AMPH versus placebo was estimated using least-square (LS) means. Treatment interaction by gender was analyzed using a cross-sectional fixed-effects model.
RESULTS


ADHD-RS-IV scores were comparable for males and females at study entry and at the end of open-label treatment. During double-blind treatment, LS mean scores significantly improved for both genders versus placebo on the SKAMP scale and the PERMP (average p < 0.0001 for all post-dose time points). Beginning at baseline, males had significantly higher (worse) SKAMP scores than females but not worse ADHD-RS-IV or PERMP scores.
CONCLUSION


Both genders responded well to treatment with RA-AMPH, with comparable onset and duration of effect. The ADHD-RS-IV and SKAMP scales both measure changes in attention and hyperactive-impulsive behavior, but the SKAMP scale also measures associated disruptive behaviors, such as frustration, lying, and interpersonal conflict, that are more characteristic of oppositional and conduct disorders and more prevalent in boys with ADHD. Therefore, the SKAMP may be more sensitive for measuring the range of symptoms of boys with ADHD than the ADHD-RS-IV.
FUNDING


Arbor Pharmaceuticals, LLC.",2019,"During double-blind treatment, LS mean scores significantly improved for both genders versus placebo on the SKAMP scale and the PERMP (average p < 0.0001 for all post-dose time points).","['children aged 6-12\xa0years with attention-deficit/hyperactivity disorder (ADHD', 'Children with Attention-Deficit/Hyperactivity Disorder', '97 subjects (38 females and 59 males']","['placebo', 'SKAMP', 'Racemic Amphetamine Sulfate', 'racemic amphetamine sulfate (RA-AMPH', 'RA-AMPH followed by placebo']","['SKAMP and the Permanent Product Measure of Performance (PERMP', 'ADHD Rating Scale-IV (ADHD-RS-IV) and Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) rating scales', 'LS mean scores', 'SKAMP scale and the PERMP', 'ADHD-RS-IV scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0282051', 'cui_str': 'Amphetamine Sulfate'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",97.0,0.108237,"During double-blind treatment, LS mean scores significantly improved for both genders versus placebo on the SKAMP scale and the PERMP (average p < 0.0001 for all post-dose time points).","[{'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Childress', 'Affiliation': 'Center for Psychiatry and Behavioral Medicine, Las Vegas, NV, USA. drann87@aol.com.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Newcorn', 'Affiliation': 'Mount Sinai Medical Center, New York, NY, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cutler', 'Affiliation': 'Meridien Research, Bradenton, FL, USA.'}]",Advances in therapy,['10.1007/s12325-019-00942-5']
1448,30496423,Optimizing decision-making among childcare staff on fever and common infections: cluster randomized controlled trial.,"BACKGROUND


Children 0-4 years attending childcare are more prone to acquire infections than home-cared children. Childcare illness absenteeism due to fever is mostly driven by fear towards fever in childcare staff and parents. This may cause high childcare absenteeism, healthcare service use, and work absenteeism in parents. This study evaluates a multicomponent intervention targeting determinants of decision-making among childcare staff on illness absenteeism due to fever and common infections.
METHODS


The multicomponent intervention was developed based on the Intervention Mapping approach and consisted of (i) an educational session, (ii) a decision tool, (iii) an information booklet and (iv) an online video. The intervention was evaluated in a cluster randomized controlled trial in Southern Netherlands. Nine centres received the intervention and nine provided childcare-as-usual. Primary outcome measure was the percentage of illness absenteeism on cluster level, defined as number of childcare days absent due to illness on total of registered childcare contract days in a 12-week period. Secondary outcome measures included intended behaviour, attitude, risk perception, knowledge and self-efficacy of childcare staff. Outcomes were analyzed using linear mixed models accounting for clustering. Knowledge was descriptively analysed.
RESULTS


Overall illness absenteeism was comparable in intervention (2.95%) and control group (2.52%). Secondary outcomes showed significant improvements in intervention group regarding intended behaviour, two of three attitude dimensions. Knowledge increased compared with control but no differences regarding self-efficacy.
CONCLUSION


The intervention was not effective in reducing illness absenteeism. However, the intervention improved determinants of decision-making such as intended behaviour, attitude, and knowledge on fever.
TRIAL REGISTRATION


NTR6402 (registered on 21 April 2017).",2019,"RESULTS


Overall illness absenteeism was comparable in intervention (2.95%) and control group (2.52%).","['Children 0-4 years attending childcare', 'childcare staff on illness absenteeism due to fever and common infections', 'childcare staff on fever and common infections', 'Southern Netherlands']","['intervention and nine provided childcare-as-usual', 'multicomponent intervention', 'Intervention Mapping approach and consisted of (i) an educational session, (ii) a decision tool, (iii) an information booklet and (iv) an online video']","['illness absenteeism', 'percentage of illness absenteeism on cluster level, defined as number of childcare days absent due to illness on total of registered childcare contract days', 'intended behaviour, attitude, risk perception, knowledge and self-efficacy of childcare staff', 'Overall illness absenteeism', 'decision-making such as intended behaviour, attitude, and knowledge on fever']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}]",,0.161949,"RESULTS


Overall illness absenteeism was comparable in intervention (2.95%) and control group (2.52%).","[{'ForeName': 'K K B', 'Initials': 'KKB', 'LastName': 'Peetoom', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Crutzen', 'Affiliation': 'Department of Health Promotion, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Verhoeven', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'J M H A', 'Initials': 'JMHA', 'LastName': 'Bohnen', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Department of Methodology and Statistics, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Dinant', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'J W L', 'Initials': 'JWL', 'LastName': 'Cals', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}]",European journal of public health,['10.1093/eurpub/cky246']
1449,30693573,"JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-Infected Patients Without Cirrhosis: OMEGA-1.","The combination of three direct-acting antiviral agents (AL-335, odalasvir, and simeprevir: JNJ-4178 regimen) for 6 or 8 weeks demonstrated good efficacy and safety in a phase IIa study in chronic hepatitis C virus (HCV) genotype (GT)-1-infected patients without cirrhosis and has now been evaluated in a larger phase IIb study, OMEGA-1. This multicenter, randomized, open-label study (NCT02765490) enrolled treatment-naïve and interferon (±ribavirin) treatment-experienced patients with HCV GT1, 2, 4, 5, or 6 infection. Patients with HCV GT3 infection and/or liver cirrhosis were excluded. Patients received AL-335 800 mg, odalasvir 25 mg, and simeprevir 75 mg once daily for 6 or 8 weeks. The primary endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12). In total, 365 patients (GT1a, 29.3%; GT1b, 42.5%; GT2, 12.3%; GT4, 14.2%; GT5, 1.4%; GT6, 0%) were randomized to receive 6 weeks (n = 183) or 8 weeks (n = 182) of treatment. SVR12 rates after 6 weeks (98.9%) or 8 weeks (97.8%) of treatment were noninferior to a historical control (98%). Viral relapse occurred in 5 patients (1.4%; 4 with HCV GT2c; 1 with GT1a). With the exception of 4 patients in the 8-week group, including 3 patients with missing data at the SVR24 timepoint, all patients who achieved SVR12 also achieved SVR24. One GT1a-infected patient experienced late viral relapse after achieving SVR18. Most adverse events (AEs) were mild with no treatment-related serious AEs. All randomized patients completed treatment. Conclusion: In HCV-infected patients, 6 and 8 weeks of treatment with JNJ-4178 resulted in SVR12 rates of 98.9% and 97.8%, respectively, and was well tolerated.",2019,Viral relapse occurred in 5 patients (1.4%; 4 with HCV GT2c; 1 with GT1a).,"['Patients with HCV GT3 infection and/or liver cirrhosis', 'chronic hepatitis C virus (HCV) genotype (GT)-1-infected patients without cirrhosis', 'experienced patients with HCV GT1, 2, 4, 5, or 6 infection']","['JNJ-4178', 'interferon (±ribavirin) treatment', 'AL-335 800 mg, odalasvir 25 mg, and simeprevir 75\xa0mg once daily for 6 or 8 weeks']","['late viral relapse', 'tolerated', 'SVR12 also achieved SVR24', 'Viral relapse', 'JNJ-4178 (AL-335, Odalasvir, and Simeprevir', 'sustained virologic response', 'SVR12 rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C3805156', 'cui_str': 'Chronic hepatitis C virus genotype 1'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]","[{'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C2605855', 'cui_str': 'simeprevir'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C2605855', 'cui_str': 'simeprevir'}, {'cui': 'C0205466', 'cui_str': 'virology'}]",365.0,0.0237121,Viral relapse occurred in 5 patients (1.4%; 4 with HCV GT2c; 1 with GT1a).,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Zeuzem', 'Affiliation': 'Department of Medicine, J.W. Goethe University Hospital, Frankfurt am Main, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bourgeois', 'Affiliation': 'Department of Gastroenterology and Hepatology, ZNA Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Greenbloom', 'Affiliation': 'Toronto Digestive Disease Associates, Inc., Vaughan, ON, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Buti', 'Affiliation': ""Hospital Vall d'Hebron and Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain.""}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Aghemo', 'Affiliation': 'Humanitas University and Research Hospital, Rozzano, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Lampertico', 'Affiliation': 'CRC ""AM e A Migliavacca,"" Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca\' Granda Ospedale Maggiore Policlinico, Università di Milano, Milan, Italy.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Janczewska', 'Affiliation': 'Outpatients Clinic for Hepatology, ID Clinic, Myslowice, Poland.'}, {'ForeName': 'Seng Gee', 'Initials': 'SG', 'LastName': 'Lim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Yong Loo Lin School of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Buggisch', 'Affiliation': 'Institute for Interdisciplinary Medicine, Hamburg, Germany.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Tam', 'Affiliation': 'LAIR Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Corbett', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Willems', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Vijgen', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Fevery', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Sivi', 'Initials': 'S', 'LastName': 'Ouwerkerk-Mahadevan', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Ackaert', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Beumont', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Kalmeijer', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, NJ.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, NJ.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Biermer', 'Affiliation': 'Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30527']
1450,31004325,"Study Protocol for a Prospective, Multicenter, Randomized, Open-Label, Parallel-Group Clinical Trial Comparing the Efficacy and Safety of a Needle-Free Insulin Injector and a Conventional Insulin Pen in Controlling Blood Glucose Concentrations in Chinese Patients with Type 2 Diabetes Mellitus (The FREE Study).","INTRODUCTION


China has the largest number of diabetic patients in the world. In the past 2 decades, the prevalence of diabetes in China has increased dramatically, and the current status of diabetes control in the diabetic population is not satisfactory. Although insulin is currently recognized in diabetes treatment guidelines as the therapeutic option for patients not adequately controlled by diet/exercise and oral agents, the proportion of patients with type 2 diabetes using insulin is still very low, and the time when insulin therapy is initiated is relatively late. In using insulin injections, concerns about the complexity of the treatment regimen, a fear of needles, and other psychological barriers can affect insulin treatment, impacting on patient compliance and potentially resulting in a poor treatment response. Another type of insulin injection device that has become available recently, the needle-free injector, is now being used in clinical practice because of its unique features and patients' injection experiences. The aims of this study are to investigate the efficacy and safety of the needle-free injector-based insulin treatment in blood glucose control in patients with type 2 diabetes, as compared with a conventional needle-based insulin treatment, and to evaluate patient satisfaction with the different insulin delivery methods.
METHODS AND PLANNED OUTCOMES


A prospective, multicenter, randomized, open-label, parallel-group clinical trial was designed and implemented in China. A total of 420 patients with type 2 diabetes from ten research centers will be enrolled in the study. The primary efficacy endpoint is the change in the glycosylated hemoglobin (HbA1c) level from baseline to after 16 weeks of treatment after randomization. Secondary efficacy endpoints include measurements of blood glucose concentrations, the rate of achieving the target HbA1c level of less than 7%, patients' quality-of-life (as determined by the SF-36 questionnaire), the insulin dose administered, compliance with insulin therapy, and patients' satisfaction with their injection device.
ETHICS AND DISSEMINATION


The study was approved by the Independent Ethics Committee (IEC) of Peking University Peoples Hospital and was conducted in accordance with the moral, ethical, and scientific principles of the declaration of Helsinki and the provisions of good clinical practice (GCP) in China. Written informed consent will be obtained from all participants before any study-related procedures are implemented. It is hoped that the study will provide evidence for the clinical application of the needle-free injector by providing data on its efficacy and safety, as compared with a conventional insulin pen, in the Chinese type 2 diabetes population. When available, the results will be published in an international peer-reviewed journal.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier, NCT03243903. Registration date, August 9, 2017.
FUNDING


Beijing QS Medical Technology Co., Ltd.",2019,"Another type of insulin injection device that has become available recently, the needle-free injector, is now being used in clinical practice because of its unique features and patients' injection experiences.","['Chinese type 2 diabetes population', '420 patients with type 2 diabetes from ten research centers will be enrolled in the study', 'patients with type 2 diabetes', 'Chinese Patients with Type 2 Diabetes Mellitus (The FREE Study']","['Needle-Free Insulin Injector and a Conventional Insulin Pen', 'conventional needle-based insulin treatment', 'needle-free injector-based insulin treatment']","['glycosylated hemoglobin (HbA1c) level', ""blood glucose concentrations, the rate of achieving the target HbA1c level of less than 7%, patients' quality-of-life (as determined by the SF-36 questionnaire), the insulin dose administered, compliance with insulin therapy, and patients' satisfaction with their injection device"", 'blood glucose control', 'efficacy and safety']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0487017', 'cui_str': 'Free insulin (substance)'}, {'cui': 'C0181342', 'cui_str': 'Injector'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4319659', 'cui_str': 'Pen (unit of presentation)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C1318607', 'cui_str': 'HBA1c target'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0794888', 'cui_str': 'Injection device (physical object)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",420.0,0.0319014,"Another type of insulin injection device that has become available recently, the needle-free injector, is now being used in clinical practice because of its unique features and patients' injection experiences.","[{'ForeName': 'LiNong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Endocrinology and Metabolism, Peking University Peoples Hospital, Beijing, China. jiln@bjmu.edu.cn.'}, {'ForeName': 'LiMing', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Metabolic Disease Hospital, Tianjin Medical University, Heping District, Tianjin, China.'}, {'ForeName': 'YanGang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'ZhongShu', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology and Metabolism, General Hospital of\xa0Tianjin\xa0Medical University, Tianjin, China.'}, {'ForeName': 'XingWu', 'Initials': 'X', 'LastName': 'Ran', 'Affiliation': 'Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'ZiLin', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology, Zhongda Hospital, Southeast University, Nanjing, China.'}, {'ForeName': 'XiangJin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, Fuzhou General Hospital of Nanjing Command, Fuzhou, Fujian Province, China.'}, {'ForeName': 'GuiXia', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology and Metabolism, The First Hospital of Jilin University, Changchun, Jilin Province, China.'}, {'ForeName': 'LiXin', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Beijing, China.'}, {'ForeName': 'ZhongYan', 'Initials': 'Z', 'LastName': 'Shan', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of China Medical University, Shenyang, China.'}]",Advances in therapy,['10.1007/s12325-019-00951-4']
1451,31397597,"Significant, long-lasting pain relief in primary dysmenorrhea with low-dose naproxen sodium compared with acetaminophen: a double-blind, randomized, single-dose, crossover study.","Objectives:  Many women experience menstrual cramps, which adversely affects quality-of-life. Both naproxen and acetaminophen are indicated to relieve menstrual pain. This study assessed the analgesic efficacy of a single, maximum non-prescription dose of naproxen sodium compared with that of acetaminophen in the treatment of primary dysmenorrhea. Methods:  Healthy females with primary dysmenorrhea were included in our double-blind, randomized, crossover study (trial registration no. NCT03448536). When pain was moderate (≥5 on 0-10 numerical rating scale), subjects took a single dose of naproxen sodium (440 mg) and crossed over to acetaminophen (1000 mg) in the next cycle, or vice versa. Total pain relief over 12 h (TOTPAR0-12) was the primary outcome, while secondary outcomes included summed pain intensity differences (SPID) and TOTPAR scores throughout 12 h, and subject overall evaluation of treatment. Results:  The per protocol population ( n  = 189) used naproxen sodium ( n  = 170) and acetaminophen ( n  = 160). TOTPAR0-12 was significantly greater with naproxen sodium than acetaminophen (least-squares (LS) mean difference = 4.31;  p  < .001), and pain intensity was significantly lower (SPID0-12 LS mean difference = 9.80;  p  < .001). Some measures of pain intensity favoring naproxen sodium became significant at earlier time points (e.g. SPID4-6 LS mean difference = 1.49;  p  = .02). After 6 h post-dose, naproxen sodium was significantly more effective than acetaminophen, maintained for 12 h (SPID6-12 LS mean difference = 8.27; TOTPAR6-12 LS mean difference = 3.75; both  p  < .001). Significantly more subjects rated naproxen sodium as good-to-excellent (70.6%) vs acetaminophen (63.1%) ( p  = .002). Conclusions:  A single, maximum non-prescription dose of naproxen sodium was more effective than acetaminophen over 12 h.",2019,"p  < .001), and pain intensity was significantly lower (SPID0-12 LS mean difference = 9.80;  p  < .001).","['primary dysmenorrhea', 'Healthy females with primary dysmenorrhea']","['naproxen sodium', 'acetaminophen', 'naproxen and acetaminophen', 'acetaminophen (least-squares (LS']","['pain intensity', 'Total pain relief', 'menstrual pain', 'summed pain intensity differences (SPID) and TOTPAR scores throughout 12\u2009h, and subject overall evaluation of treatment', 'analgesic efficacy']","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0546873', 'cui_str': 'Naproxen sodium'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",,0.49797,"p  < .001), and pain intensity was significantly lower (SPID0-12 LS mean difference = 9.80;  p  < .001).","[{'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Daniels', 'Affiliation': 'Independent Consultant.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Paredes-Diaz', 'Affiliation': 'Consumer Health, Bayer Healthcare, Whippany, NJ, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'An', 'Affiliation': 'Consumer Health, Bayer Healthcare, Whippany, NJ, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Centofanti', 'Affiliation': 'Consumer Health, Bayer Healthcare, Whippany, NJ, USA.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Tajaddini', 'Affiliation': 'Consumer Health, Bayer Healthcare, Whippany, NJ, USA.'}]",Current medical research and opinion,['10.1080/03007995.2019.1654987']
1452,31125092,Further Nonvertebral Fracture Reduction Beyond 3 Years for Up to 10 Years of Denosumab Treatment.,"CONTEXT


Evidence for further nonvertebral fracture (NVF) reductions with long-term antiresorptive therapy in osteoporosis is lacking.
OBJECTIVE


To evaluate NVF risk reduction in subjects receiving ≤10 years of denosumab treatment.
DESIGN


Phase 3, randomized, placebo-controlled, 3-year Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) trial (NCT00089791) and its open-label 7-year extension (NCT00523341).
SETTING


One hundred seventy-two study centers worldwide.
PATIENTS


Women 60 to 90 years, lumbar spine or total hip bone mineral density T-scores <-2.5 (≥-4.0 at both).
INTERVENTIONS


Subjects randomly assigned 1:1 denosumab 60 mg SC Q6M (long-term) or placebo (crossover) in FREEDOM; eligible subjects could enroll in the extension to receive denosumab 60 mg SC Q6M.
MAIN OUTCOME MEASURES


NVF Exposure-adjusted subject incidence (per 100 subject-years) during denosumab treatment years 1 to 3 and 4 to 7 (all subjects) and years 4 to 10 (long-term only), and rate ratios (RRs) for years 4 to 7 or 4 to 10 vs 1 to 3.
RESULTS


Among 4074 subjects (2343 long-term, 1731 crossover), NVF rates (95% CI) in all subjects were 2.15 (1.90 to 2.43) during years 1 to 3 and 1.53 (1.34 to 1.75) during years 4 to 7 of denosumab treatment [RR (95% CI) = 0.72 (0.61 to 0.86); P < 0.001]; in long-term only were 1.98 (1.67 to 2.34) during years 1 to 3 and 1.44 (1.24 to 1.66) during years 4 to 10 [RR = 0.74 (0.60 to 0.93); P = 0.008]. combined osteonecrosis of the jaw and atypical femoral fracture rate was 0.06.
CONCLUSIONS


Long-term denosumab treatment, >3 and ≤10 years, was associated with further reductions in NVF rates compared with the first 3 years.",2019,"Among 4074 subjects (2343 long-term, 1731 crossover), NVF rates (95% CI) in all subjects were 2.15 (1.90 to 2.43) during years 1 to 3 and 1.53 (1.34 to 1.75) during years 4 to 7 of denosumab treatment [RR (95% CI) =","['Women 60 to 90 years, lumbar spine or total hip bone mineral density T-scores <-2.5 (≥-4.0 at both', 'Osteoporosis', '4074 subjects (2343 long-term, 1731 crossover), NVF rates (95% CI) in all subjects were 2.15 (1.90 to 2.43) during years 1 to 3 and 1.53 (1.34 to 1.75) during years 4 to 7 of denosumab treatment [RR (95% CI) ', 'One hundred seventy-two study centers worldwide', 'subjects receiving ≤10 years of denosumab treatment', 'treatment years 1 to 3 and 4 to 7 (all subjects) and years 4 to 10 (long-term only), and rate ratios (RRs) for years 4 to 7 or 4 to 10 vs 1 to 3']","['placebo', 'Denosumab', 'denosumab 60 mg SC Q6M (long-term) or placebo', 'denosumab 60 mg SC Q6M', 'denosumab']","['combined osteonecrosis of the jaw and atypical femoral fracture rate', 'Nonvertebral Fracture Reduction', 'NVF rates', 'NVF risk reduction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4517506', 'cui_str': '1.53'}, {'cui': 'C4517501', 'cui_str': '1.34'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C1112432', 'cui_str': 'Reduction of fracture'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",4074.0,0.03351,"Among 4074 subjects (2343 long-term, 1731 crossover), NVF rates (95% CI) in all subjects were 2.15 (1.90 to 2.43) during years 1 to 3 and 1.53 (1.34 to 1.75) during years 4 to 7 of denosumab treatment [RR (95% CI) =","[{'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Ferrari', 'Affiliation': 'Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Butler', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Kendler', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Miller', 'Affiliation': 'Colorado Center for Bone Research, Lakewood, Colorado.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Roux', 'Affiliation': 'Paris Descartes University, Paris, France.'}, {'ForeName': 'Andrea T', 'Initials': 'AT', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Wagman', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'E Michael', 'Initials': 'EM', 'LastName': 'Lewiecki', 'Affiliation': 'New Mexico Clinical Research & Osteoporosis Center, Albuquerque, New Mexico.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00271']
1453,30950190,An mHealth voice messaging intervention to improve infant and young child feeding practices in Senegal.,"Mobile health (mHealth) interventions have the potential to improve infant and young child feeding (IYCF) practices; however, gaps in the literature remain regarding their design, implementation, and effectiveness. The aims of this study were to design an mHealth voice messaging intervention delivered to mothers and fathers targeting IYCF practices and examine its implementation and impact in households with children 6-23 months in three rural villages in Senegal. We conducted focus groups (n = 6) to inform the intervention development. We then conducted a pilot study (n = 47 households) to examine the impact of the intervention on IYCF practices of children 6-23 months. Voice messages were sent to the children's mothers and fathers over a period of 4 weeks (two messages per week; eight messages in total), and 24-hr dietary recalls and food frequency questionnaires (FFQs) were conducted before and immediately after the implementation of the mHealth intervention to examine its impact on IYCF practices. Overall, three of the eight behaviours increased and one decreased. There was a significant increase in the number of children that consumed fish (60% vs. 94%; p = .008) as measured by the 24-hr recall after the completion of the intervention. We also found significantly higher frequency of egg (p = .026), fish (p = .004), and thick porridge (p = .002) consumption in the previous 7 days measured by the FFQ. Our findings suggest that voice messaging IYCF interventions in Senegal have the potential to improve IYCF behaviours among young children in the short term. Future research should entail scaling-up the intervention and examining its sustainability over the long-term.",2019,"We also found significantly higher frequency of egg (p = .026), fish (p = .004), and thick porridge (p = .002) consumption in the previous 7 days measured by the FFQ.","['pilot study (n\xa0=\xa047 households', 'households with children 6-23\xa0months in three rural villages in Senegal', 'infant and young child feeding practices in Senegal', 'children 6-23\xa0months']","['mHealth voice messaging intervention', 'Mobile health (mHealth) interventions']","['IYCF behaviours', 'number of children that consumed fish', 'thick porridge', '24-hr dietary recalls and food frequency questionnaires (FFQs']","[{'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0036644', 'cui_str': 'Republic of Senegal'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C1280412', 'cui_str': 'Thick (qualifier value)'}, {'cui': 'C0452575', 'cui_str': 'Porridge (substance)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.033954,"We also found significantly higher frequency of egg (p = .026), fish (p = .004), and thick porridge (p = .002) consumption in the previous 7 days measured by the FFQ.","[{'ForeName': 'Shauna M', 'Initials': 'SM', 'LastName': 'Downs', 'Affiliation': 'Department of Urban-Global Public Health, Rutgers School of Public Health, Newark, New Jersey.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Sackey', 'Affiliation': 'Department of Clinical and Preventive Nutrition Science, Rutgers School of Health Professions, Newark, New Jersey.'}, {'ForeName': 'Jozefina', 'Initials': 'J', 'LastName': 'Kalaj', 'Affiliation': 'Department of Economics, George Washington University, Washington, District of Columbia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Department of Economics, George Washington University, Washington, District of Columbia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fanzo', 'Affiliation': 'Berman Institute of Bioethics & School of Advanced International Studies, Johns Hopkins University, Baltimore, Maryland.'}]",Maternal & child nutrition,['10.1111/mcn.12825']
1454,31753198,Effects of Interatrial Shunt on Pulmonary Vascular Function in Heart Failure With Preserved Ejection Fraction.,"BACKGROUND


Implantation of an interatrial shunt device (IASD) in patients with heart failure (HF) reduces left atrial hypertension by shunting oxygenated blood to the right heart and lungs. The attendant increases in pulmonary blood flow (Qp) and oxygen content may alter pulmonary vascular function, while left-to-right shunting might compromise systemic perfusion.
OBJECTIVES


The authors hypothesized that IASD would improve indexes of pulmonary artery (PA) function at rest and during exercise in HF patients without reducing systemic blood flow (Qs).
METHODS


This is a pooled analysis from 2 trials assessing the effects of the IASD on resting and exercise hemodynamics in HF patients (n = 79) with EF ≥40% with baseline and repeated hemodynamic evaluation between 1 and 6 months. Patients with pulmonary vascular resistance (PVR) >4 WU or right ventricular dysfunction were excluded.
RESULTS


Qp and PA oxygen content increased by 27% and 7% following IASD. These changes were associated with salutary effects on pulmonary vascular function (17% reduction in PVR, 12% reduction in PA elastance [pulmonary Ea], and 24% increase in PA compliance). Qp increased during exercise to a greater extent following IASD compared with baseline, which was associated with reductions in exercise PVR and pulmonary Ea. Patients with increases in PA compliance following IASD experienced greater improvements in supine exercise duration. There was no reduction in Qs following IASD at rest or during exercise.
CONCLUSIONS


Implantation of an IASD improves pulmonary vascular function at rest and during exercise in selected patients with HF and EF ≥40%, without compromising systemic perfusion. Further study is warranted to identify underlying mechanisms and long-term pulmonary hemodynamic effects of IASD. (REDUCE LAP-HF Trial [REDUCE LAP-HF]; NCT01913613; and REDUCE LAP-HF Randomized Trial I [REDUCE LAP-HF I]; NCT02600234).",2019,"Qp increased during exercise to a greater extent following IASD compared with baseline, which was associated with reductions in exercise PVR and pulmonary","['patients with heart failure (HF) reduces left atrial hypertension by shunting oxygenated blood to the right heart and lungs', 'HF patients (n\xa0=\xa079) with EF\xa0≥40% with baseline and repeated hemodynamic evaluation between 1 and 6\xa0months', 'Heart\xa0Failure', 'Patients with pulmonary vascular resistance (PVR) >4 WU or right ventricular dysfunction were excluded']","['interatrial shunt device (IASD', 'Interatrial Shunt', 'IASD']","['Pulmonary Vascular Function', 'resting and exercise hemodynamics', 'supine exercise duration', 'exercise PVR and pulmonary', 'PA oxygen content', 'PA compliance', 'systemic blood flow (Qs', 'pulmonary blood flow (Qp) and oxygen content', 'pulmonary vascular function', 'Qp', 'indexes of pulmonary artery (PA) function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1442858', 'cui_str': 'Surgical fistula'}, {'cui': 'C0005768'}, {'cui': 'C0546911', 'cui_str': 'To the right (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C0242707', 'cui_str': 'Right Ventricular Dysfunction'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C4544192', 'cui_str': 'Interatrial shunt (physical object)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary Artery'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.119726,"Qp increased during exercise to a greater extent following IASD compared with baseline, which was associated with reductions in exercise PVR and pulmonary","[{'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Obokata', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Yogesh N V', 'Initials': 'YNV', 'LastName': 'Reddy', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Division of Cardiology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kaye', 'Affiliation': 'Baker IDI Heart and Diabetes Institute and Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Hasenfuβ', 'Affiliation': 'Georg-August Universität, Heart Centre, Gottingen, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Hoendermis', 'Affiliation': 'University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Sheldon E', 'Initials': 'SE', 'LastName': 'Litwin', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Komtebedde', 'Affiliation': 'Corvia Medical, Tewksbury, Massachusetts.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Lam', 'Affiliation': 'University Medical Center Groningen, Groningen, the Netherlands; National Heart Centre Singapore and Duke-National University of Singapore, Singapore; The George Institute for Global Health, Newtown, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Burkhoff', 'Affiliation': 'Division of Cardiology, Columbia University, New York, New York.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Borlaug', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota. Electronic address: borlaug.barry@mayo.edu.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.08.1062']
1455,31678947,Protocol for a randomised controlled trial of the combined effects of the GLP-1 receptor agonist liraglutide and exercise on maintenance of weight loss and health after a very low-calorie diet.,"INTRODUCTION


The success rate of weight loss maintenance is limited. Therefore, the purpose of this study is to investigate the maintenance of weight loss and immunometabolic health outcomes after diet-induced weight loss followed by 1-year treatment with a glucagon-like peptide-1 receptor agonist (liraglutide), physical exercise or the combination of both treatments as compared with placebo in individuals with obesity.
METHODS AND ANALYSIS


This is an investigator-initiated, randomised, placebo-controlled, parallel group trial. We will enrol expectedly 200 women and men (age 18-65 years) with obesity (body mass index 32-43 kg/m 2 ) to adhere to a very low-calorie diet (800 kcal/day) for 8 weeks in order to lose at least 5% of body weight. Subsequently, participants will be randomised in a 1:1:1:1 ratio to one of four study groups for 52 weeks: (1) placebo, (2) exercise 150 min/week+placebo, (3) liraglutide 3.0 mg/day and (4) exercise 150 min/week+liraglutide 3.0 mg/day. The primary endpoint is change in body weight from randomisation to end-of-treatment.
ETHICS AND DISSEMINATION


The trial has been approved by the ethical committee of the Capital Region of Denmark and the Danish Medicines Agency. The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER


2015-005585-32.",2019,We will enrol expectedly 200 women and men (age 18-65 years) with obesity (body mass index 32-43 kg/m 2 ) to adhere to a very low-calorie diet (800 kcal/day) for 8 weeks in order to lose at least 5% of body weight.,"['individuals with obesity', '200 women and men (age 18-65 years) with obesity (body mass index 32-43\u2009kg/m 2 ) to adhere to a very low-calorie diet (800 kcal/day) for 8\u2009weeks in order to lose at least 5% of body weight']","['GLP-1 receptor agonist liraglutide and exercise', 'placebo', 'glucagon-like peptide-1 receptor agonist (liraglutide), physical exercise', 'placebo, (2) exercise 150\u2009min/week+placebo, (3) liraglutide 3.0\u2009mg/day and (4) exercise 150\u2009min/week+liraglutide 3.0\u2009mg/day']","['weight loss and health', 'success rate of weight loss maintenance', 'change in body weight from randomisation to end-of-treatment']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet (finding)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]","[{'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",200.0,0.155604,We will enrol expectedly 200 women and men (age 18-65 years) with obesity (body mass index 32-43 kg/m 2 ) to adhere to a very low-calorie diet (800 kcal/day) for 8 weeks in order to lose at least 5% of body weight.,"[{'ForeName': 'Simon Birk Kjær', 'Initials': 'SBK', 'LastName': 'Jensen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Julie Rehné', 'Initials': 'JR', 'LastName': 'Lundgren', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Janus', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian Rimer', 'Initials': 'CR', 'LastName': 'Juhl', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lisa Møller', 'Initials': 'LM', 'LastName': 'Olsen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Rosenkilde', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente Merete', 'Initials': 'BM', 'LastName': 'Stallknecht', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Signe Sørensen', 'Initials': 'SS', 'LastName': 'Torekov', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark torekov@sund.ku.dk.'}]",BMJ open,['10.1136/bmjopen-2019-031431']
1456,31120533,Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial.,"Importance


Tinnitus retraining therapy (TRT) is an internationally recognized, but controversial, protocol of uncertain efficacy that uses tinnitus-specific educational counseling (TC) and sound therapy (ST) to reduce the patient's tinnitus-evoked negative reaction to, and awareness of, tinnitus.
Objective


To compare the efficacy of TRT and its components, ST and TC, with the standard of care (SoC) in reducing the negative effect of tinnitus on quality of life.
Design, Setting, and Participants


A randomized, placebo-controlled, multicenter phase 3 trial was conducted from August 4, 2011, to June 20, 2017, at 6 US military hospitals, the study chairs' office, and a data coordinating center, among 151 active-duty and retired military personnel and dependents with functionally adequate hearing sensitivity and moderate to severe subjective tinnitus. All analyses were based on intention to treat.
Interventions


Central randomized allocation to TRT (TC and ST with conventional sound generators), partial TRT (TC with placebo sound generators), or SoC.
Main Outcomes and Measures


The primary outcome was mean change on the Tinnitus Questionnaire (TQ), assessed longitudinally between baseline and 18 months after start of therapy. The secondary outcomes were changes in TQ subscales, Tinnitus Functional Index (TFI), and Tinnitus Handicap Inventory (THI) total and subscales, as well as a 10-point visual analog scale (VAS).
Results


Among the 151 participants in the study (44 women and 107 men; mean [SD] age, 50.6 [11.3] years), 51 were randomized to receive TRT, 51 to receive partial TRT, and 49 to receive standard of care. Longitudinal analyses showed no difference between partial TRT or TRT compared with SoC, or partial TRT compared with TRT, on TQ, TFI, or THI total scores. Comparison of changes in mean score from baseline to the 18-month visit also showed no difference between treatment groups. Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, -1.32; 95% CI, -1.78 to -0.85), partial TRT (effect size, -1.16; 95% CI, -1.56 to -0.76), and SoC (effect size, -1.01; 95% CI, -1.41 to -0.61). Compared with baseline scores, at 18 months there were reductions in scores by 7 points or more on the TQ score for 86 of 111 participants (77.55%; 95% CI, 69.7%-85.2%), 13 points or more on the TFI for 52 of 111 participants (46.8%; 95% CI, 37.6%-56.1%), 7 points or more on the THI for 63 of 111 participants (56.8%; 95% CI, 47.5%-66.0%), and 2 points or more on the VAS for 45 of 93 participants (48.4%; 95% CI, 38.2%-58.5%).
Conclusions and Relevance


There were few differences between treatment groups. About half of participants showed clinically meaningful reductions in the effect of tinnitus.
Trial Registration


ClinicalTrials.gov identifier: NCT01177137.",2019,"Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, -1.32; 95% CI, -1.78 to -0.85), partial TRT (effect size, -1.16; 95% CI, -1.56 to -0.76), and SoC (effect size, -1.01; 95% CI, -1.41 to -0.61).","['151 participants in the study (44 women and 107 men; mean [SD] age, 50.6 [11.3] years', ""August 4, 2011, to June 20, 2017, at 6 US military hospitals, the study chairs' office, and a data coordinating center, among 151 active-duty and retired military personnel and dependents with functionally adequate hearing sensitivity and moderate to severe subjective tinnitus""]","['Tinnitus Retraining Therapy vs Standard of Care', 'TRT', 'placebo', 'tinnitus-specific educational counseling (TC) and sound therapy (ST', 'TRT (TC and ST with conventional sound generators), partial TRT (TC with placebo sound generators), or SoC.\nMain Outcomes and Measures', 'Tinnitus retraining therapy (TRT', 'partial TRT']","['TQ score', 'TQ scores', 'mean change on the Tinnitus Questionnaire (TQ', 'changes in TQ subscales, Tinnitus Functional Index (TFI), and Tinnitus Handicap Inventory (THI) total and subscales, as well as a 10-point visual analog scale (VAS', 'TQ, TFI, or THI total scores', 'quality of life', 'Tinnitus-Related Quality of Life', 'partial TRT']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0035345', 'cui_str': 'Retirement'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034380'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",44.0,0.343141,"Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, -1.32; 95% CI, -1.78 to -0.85), partial TRT (effect size, -1.16; 95% CI, -1.56 to -0.76), and SoC (effect size, -1.01; 95% CI, -1.41 to -0.61).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Roberta W', 'Initials': 'RW', 'LastName': 'Scherer', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Formby', 'Affiliation': 'Department of Communicative Disorders, University of Alabama, Tuscaloosa.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2019.0821']
1457,30614066,"Management of people with Type 2 diabetes shared between a specialized outpatient clinic and primary health care is noninferior to management in a specialized outpatient clinic: a randomized, noninferiority trial.","AIM


To evaluate whether management of people with Type 2 diabetes shared between a specialized outpatient clinic and primary health care has noninferior HbA 1c  outcomes compared with mono-sectorial management in a specialized outpatient clinic.
METHODS


A randomized controlled, noninferiority study. People with moderate hyperglycaemia, hypertension and/or incipient complications were eligible for the study. All participants had annual comprehensive check-ups at the outpatient clinic. Quarterly check-ups were conducted by general practitioners (GPs) for the shared care group and by endocrinologists at the outpatient clinic for the control group. The primary outcome was the mean difference in HbA 1c  from baseline to 12 months of follow-up. The noninferiority margin for HbA 1c  was 4.4 mmol/mol.
RESULTS


A total of 140 people were randomized [age 65.0 ± 0.9 years, HbA 1c  52 ± 0.8 mmol/mol (6.9 ± 0.1%), systolic BP 135.6 ± 1.1 mmHg; all mean ± sem]. Peripheral neuropathy was present in 68% of participants and microalbuminuria in 19%; 15% had history of a previous major cardiovascular event. Among study completers (n = 133), HbA 1c  increased by 2.3 mmol/mol (0.2%) in the shared care group and by 1.0 mmol/mol (0.1%) in the control group, with a between-group difference of 1.3 mmol/mol [90% confidence interval (CI) -1.3, 3.9] (0.1%, 90% CI -0.1, 0.4). Noninferiority was confirmed in both per protocol and intention to treat analyses.
CONCLUSION


We found that our shared care programme was noninferior to specialized outpatient management in maintaining glycaemic control in this group of people with Type 2 diabetes. Shared care should be considered for the future diabetes management of Type 2 diabetes.",2019,We found that our shared care programme was noninferior to specialized outpatient management in maintaining glycaemic control in this group of people with Type 2 diabetes.,"['people with Type 2 diabetes shared between a specialized outpatient clinic and primary health care', 'A total of 140 people', 'people with Type 2 diabetes', 'People with moderate hyperglycaemia, hypertension and/or incipient complications were eligible for the study', 'All participants had annual comprehensive check-ups at the outpatient clinic']",[],"['mean\xa0difference in HbA 1c', 'HbA 1c', 'Peripheral neuropathy']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205256', 'cui_str': 'Incipient (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}]",140.0,0.104524,We found that our shared care programme was noninferior to specialized outpatient management in maintaining glycaemic control in this group of people with Type 2 diabetes.,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Munch', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, University of Copenhagen, Gentofte.'}, {'ForeName': 'B B', 'Initials': 'BB', 'LastName': 'Bennich', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, University of Copenhagen, Gentofte.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Overgaard', 'Affiliation': 'Institute of Nursing, University College Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Konradsen', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Huddinge, Sweden.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Middelfart', 'Affiliation': 'Rudersdalklinikken, Holte.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kaarsberg', 'Affiliation': 'Vangede Laegehus, Gentofte.'}, {'ForeName': 'F K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, University of Copenhagen, Gentofte.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, University of Copenhagen, Gentofte.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Røder', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, University of Copenhagen, Gentofte.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.13896']
1458,31687845,Considering abuse liability and neurocognitive effects of cannabis and cannabis-derived products when assessing analgesic efficacy: a comprehensive review of randomized-controlled studies.,"Background : Pain is the most frequent indication for which medical cannabis treatment is sought. Objectives : The clinical potential of cannabis and cannabis-derived products (CDPs) relies on their efficacy to treat an indication and potential adverse effects that impact outcomes, including abuse liability and neurocognitive effects. To ascertain the extent to which these effects impact therapeutic utility, studies investigating cannabis and CDPs for pain were reviewed for analgesic efficacy and assessments of abuse liability and neurocognitive effects. Methods : A comprehensive review of placebo-controlled studies investigating cannabis and CDP analgesia was performed. Methods and findings related to adverse effects, abuse liability, and neurocognitive effects were extracted. Results : Thirty-eight studies were reviewed; 29 assessed cannabis and CDPs for chronic pain, 1 for acute pain, and 8 used experimental pain tests. Most studies ascertained adverse effects through self-report (N = 27). Fewer studies specifically probed abuse liability (N = 7) and cognitive and psychomotor effects (N = 12). Many studies related to chronic and experimental pain (N = 18 and N = 5, respectively) found cannabis and CDPs to reduce pain. Overall, adverse effects were mild to moderate, and dose-related. Studies investigating the impact of cannabis and CDPs on abuse liability and neurocognitive endpoints were mostly limited to inhaled administration and confirmed dose-related effects. Conclusion : Few studies investigating cannabis and CDP analgesia assess abuse liability and cognitive endpoints, adverse effects that impact the long-term clinical utility of these drugs. Future studies should include these measures to optimize research and clinical care related to cannabis-based therapeutics.",2019,"Overall, adverse effects were mild to moderate, and dose-related.","['Thirty-eight studies were reviewed; 29 assessed cannabis and CDPs for chronic pain, 1 for acute pain, and 8 used experimental pain tests']","['cannabis and cannabis-derived products', 'cannabis and cannabis-derived products (CDPs', ' ', 'placebo']","['analgesic efficacy', 'adverse effects, abuse liability, and neurocognitive effects', 'cognitive and psychomotor effects', 'abuse liability and neurocognitive endpoints', 'Pain', 'adverse effects']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0991028,"Overall, adverse effects were mild to moderate, and dose-related.","[{'ForeName': 'Ziva D', 'Initials': 'ZD', 'LastName': 'Cooper', 'Affiliation': 'UCLA Cannabis Research Initiative, Jane and Terry Semel Institute for Neuroscience and Human Behavior, Department of Psychiatry and Biobehavioral Science, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Donald I', 'Initials': 'DI', 'LastName': 'Abrams', 'Affiliation': 'Divison of Oncology, Department of Medicine, Zuckerberg San Francisco General, University of California San Francisco, San Francisco, CA, USA.'}]",The American journal of drug and alcohol abuse,['10.1080/00952990.2019.1669628']
1459,31414959,Influence of dietary inorganic nitrate on blood pressure and vascular function in hypertension: prospective implications for adjunctive treatment.,"Dietary inorganic nitrate (nitrate) is a promising adjunctive treatment to reduce blood pressure and improve vascular function in hypertension. However, it remains unknown if the efficacy of nitrate is dependent upon an elevated blood pressure or altered by medication in patients with hypertension. Therefore, blood pressure and vascular function, measured by passive leg movement (PLM) and flow-mediated dilation (FMD), were assessed following 3 days of placebo (nitrate-free beetroot juice) and nitrate (nitrate-rich beetroot juice) administration in 13 patients (age: 53 ± 12 yr) with hypertension taking antihypertensive medications ( study 1 ) and in 14 patients (49 ± 13 yr) with hypertension not taking antihypertensive medications ( study 2 ). In  study 1 , plasma nitrite concentration was greater for nitrate than placebo (341 ± 118 vs. 308 ± 123 nmol/L,  P  < 0.05), yet blood pressure and vascular function were unaltered. In  study 2 , plasma nitrite concentration was greater for nitrate than placebo (340 ± 102 vs. 295 ± 93 nmol/L,  P  < 0.01). Systolic (136 ± 16 vs. 141 ± 19 mmHg), diastolic (84 ± 13 vs. 88 ± 12 mmHg), and mean (101 ± 12 vs. 106 ± 13 mmHg) blood pressures were lower ( P  < 0.05), whereas the PLM change in leg vascular conductance (6.0 ± 3.0 vs. 5.1 ± 2.6 mL·min -1 ·mmHg -1 ) and FMD (6.1 ± 2.4% vs. 4.1 ± 2.7%) were greater ( P  < 0.05) for nitrate than placebo. The changes in systolic blood pressure ( r  = -0.60) and FMD ( r  = -0.48) induced by nitrate were inversely correlated ( P  < 0.05) to the respective baseline values obtained in the placebo condition. Thus, the efficacy of nitrate to improve blood pressure and vascular function in hypertension appears to be dependent on the degree of blood pressure elevation and vascular dysfunction and not antihypertensive medication status, per se. NEW & NOTEWORTHY  Dietary nitrate (nitrate) is a promising intervention to improve blood pressure and vascular function in hypertension. We demonstrate that these beneficial effects of nitrate are inversely related to the baseline value in a continuous manner with no distinction between antihypertensive medication status. Thus, the efficacy of nitrate to improve blood pressure and vascular function in hypertension appears to be dependent on the degree of blood pressure elevation and vascular dysfunction and not antihypertensive mediation status.",2019,"In Study 1, plasma nitrite concentration was greater for Nitrate than Placebo (341±118 vs. 308±123 nmol/l,p<0.05), yet blood pressure or vascular function were unaltered.","['13 patients (age:53±12 y) with hypertension ta king antihypertensive medications (Study 1) and in 14 patients (49±13 y) with hypertension not taking antihypertensive medications (Study 2', 'patients with hypertension', 'Hypertension']","['Dietary Inorganic Nitrate', 'Placebo', 'Dietary inorganic nitrate (Nitrate', 'Placebo (nitrate-free beetroot juice) and Nitrate (nitrate-rich beetroot juice']","['Systolic', 'blood pressure or vascular function', 'PLM change in leg vascular conductance', 'blood pressure and vascular function', 'plasma nitrite concentration', 'blood pressure and vascular function, measured by passive leg movement (PLM) and flow-mediated dilation (FMD', 'systolic blood pressure (r=-0.60) and FMD (r=-0.48) induced by Nitrate', 'FMD', 'blood pressure', 'blood pressures', 'Blood Pressure and Vascular Function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4517461', 'cui_str': '0.48'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}]",,0.0526688,"In Study 1, plasma nitrite concentration was greater for Nitrate than Placebo (341±118 vs. 308±123 nmol/l,p<0.05), yet blood pressure or vascular function were unaltered.","[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Broxterman', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'D Taylor', 'Initials': 'DT', 'LastName': 'La Salle', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Van R', 'Initials': 'VR', 'LastName': 'Reese', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Russell S', 'Initials': 'RS', 'LastName': 'Richardson', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Trinity', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00371.2019']
1460,31488353,1-Year Outcomes of Delayed Versus Immediate Intervention in Patients With Transient ST-Segment Elevation Myocardial Infarction.,"OBJECTIVES


The aim of the present study was to determine the effect of a delayed versus an immediate invasive approach on final infarct size and clinical outcome up to 1 year.
BACKGROUND


Up to 24% of patients with acute coronary syndromes present with ST-segment elevation myocardial infarction (STEMI) but show complete resolution of ST-segment elevation and symptoms before revascularization. Current guidelines do not clearly state whether these patients with transient STEMI should be treated with a STEMI-like or non-ST-segment elevation acute coronary syndrome-like intervention strategy.
METHODS


In this multicenter trial, 142 patients with transient STEMI were randomized 1:1 to either delayed or immediate coronary intervention. Cardiac magnetic resonance imaging was performed at 4 days and at 4-month follow-up to assess infarct size and myocardial function. Clinical follow-up was performed at 4 and 12 months.
RESULTS


In the delayed (22.7 h) and the immediate (0.4 h) invasive groups, final infarct size as a percentage of the left ventricle was very small (0.4% [interquartile range: 0.0% to 2.5%] vs. 0.4% [interquartile range: 0.0% to 3.5%]; p = 0.79), and left ventricular function was good (mean ejection fraction 59.3 ± 6.5% vs. 59.9 ± 5.4%; p = 0.63). In addition, the overall occurrence of major adverse cardiac events, consisting of death, recurrent infarction, and target lesion revascularization, up to 1 year was low and not different between both groups (5.7% vs. 4.4%, respectively; p = 1.00).
CONCLUSIONS


At follow-up, patients with transient STEMI have limited infarction and well-preserved myocardial function in general, and delayed or immediate revascularization has no effect on functional outcome and clinical events up to 1 year.",2019,"In addition, the overall occurrence of major adverse cardiac events, consisting of death, recurrent infarction, and target lesion revascularization, up to 1 year was low and not different between both groups (5.7% vs. 4.4%, respectively; p = 1.00).
","['patients with acute coronary syndromes present with ST-segment elevation myocardial infarction (STEMI', 'Patients With Transient ST-Segment Elevation Myocardial Infarction', '142 patients with transient STEMI']","['delayed or immediate coronary intervention', 'Cardiac magnetic resonance imaging', 'Delayed Versus Immediate Intervention']","['infarct size and myocardial function', 'overall occurrence of major adverse cardiac events, consisting of death, recurrent infarction, and target lesion revascularization', 'left ventricular function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}]",142.0,0.0882585,"In addition, the overall occurrence of major adverse cardiac events, consisting of death, recurrent infarction, and target lesion revascularization, up to 1 year was low and not different between both groups (5.7% vs. 4.4%, respectively; p = 1.00).
","[{'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Nina W', 'Initials': 'NW', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jorrit S', 'Initials': 'JS', 'LastName': 'Lemkes', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Everaars', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Koen M J', 'Initials': 'KMJ', 'LastName': 'Marques', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nap', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Maarten A H', 'Initials': 'MAH', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Yolande', 'Initials': 'Y', 'LastName': 'Appelman', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knaapen', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels J W', 'Initials': 'NJW', 'LastName': 'Verouden', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelis P', 'Initials': 'CP', 'LastName': 'Allaart', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Stijn L', 'Initials': 'SL', 'LastName': 'Brinckman', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Blaricum, the Netherlands.'}, {'ForeName': 'Colette E', 'Initials': 'CE', 'LastName': 'Saraber', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Blaricum, the Netherlands.'}, {'ForeName': 'Koos J', 'Initials': 'KJ', 'LastName': 'Plomp', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Blaricum, the Netherlands.'}, {'ForeName': 'Jorik R', 'Initials': 'JR', 'LastName': 'Timmer', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Kedhi', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Meuwissen', 'Affiliation': 'Department of Cardiology, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Schaap', 'Affiliation': 'Department of Cardiology, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Arno P', 'Initials': 'AP', 'LastName': 'van der Weerdt', 'Affiliation': 'Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands; Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands; Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: niels.vanroyen@radboudumc.nl.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.07.018']
1461,31397184,"Bronchodilator efficacy of tiotropium/formoterol (18/12 µg once daily via a Discair inhaler), tiotropium alone (18 µg by Handihaler) or combined with formoterol (12 µg twice daily by Aerolizer) in adults with moderate-to-severe stable COPD.","Objectives:  The bronchodilator efficacy of a once-daily fixed-dose combination of tiotropium/formoterol (18/12 µg administered via a dry-powder inhaler, Discair) [TIO/FORM fixed  group] vs a single-dose of tiotropium (18 µg) by Handihaler 1  alone [TIO mono  group], or combined with formoterol 12 µg twice-daily by Aerolizer 2  [TIO/FORM bid  group] was compared in patients with moderate-to-severe stable COPD. Methods:  COPD patients were randomized (28 patients/group) to receive TIO/FORM fixed , TIO mono ,  or TIO/FORM bid . AUC for the changes in FEV 1  and FVC over a 24-h period; bronchodilator response (100 ml improvement in FEV 1 ) in the first 30 min; maximum changes in FEV 1  and FVC; and safety data were recorded. The primary endpoint was to confirm the non-inferiority of TIO/FORM fixed  vs TIO/FORM bid  in terms of the AUC for the changes in FEV 1  over a 24-h period. Results:  Changes in AUC 0-24h  for FEV 1  and FVC were similar for TIO/FORM fixed  and TIO/FORM bid , and were superior to TIO mono  ( p  < 0.001). A positive bronchodilator response at 30 min was demonstrated in 50%, 64%, and 71% of patients in the TIO mono , TIO/FORM bid , and TIO/FORM fixed  groups, respectively (NS). Maximum FEV 1  and FVC changes were measured as 0.25/0.41 L, 0.32/0.49 L, and 0.37/0.53 L, for TIO mono , TIO/FORM bid , and TIO/FORM fixed , respectively (FEV 1 : TIO/FORM fixed  vs TIO mono ,  p  = 0.0017 and TIO/FORM fixed  vs TIO/FORM bid ,  p  = 0.4846); no differences were recorded between the combination groups. Conclusions:  The 24-h bronchodilator efficacy of TIO/FORM fixed  18/12 µg once-daily by Discair 3  was non-inferior to a combination of tiotropium 18 µg by Handihaler plus formoterol 12 µg twice-daily by Aerolizer, and superior to tiotropium 18 µg monotherapy by Handihaler.",2019,"A positive bronchodilator response at 30 minutes was demonstrated in 50%, 64% and 71% of patients in the TIO mono , TIO/FORM bid  and TIO/FORM fixed  groups, respectively (NS).","['adults with moderate-to-severe stable COPD', 'COPD patients']","['tiotropium/formoterol', 'tiotropium', 'TIO/FORM fixed , TIO mono  or TIO/FORM bid ', 'tiotropium alone (18 µg by Handihaler®) or combined with formoterol', 'FVC', 'Discair®', 'Handihaler® alone [TIO mono  group], or combined with formoterol 12 µg twice-daily by Aerolizer']","['Bronchodilator efficacy', '24-h bronchodilator efficacy', 'bronchodilator efficacy', 'Maximum FEV 1  and FVC changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C2355432', 'cui_str': 'TiO(tpyp)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.180891,"A positive bronchodilator response at 30 minutes was demonstrated in 50%, 64% and 71% of patients in the TIO mono , TIO/FORM bid  and TIO/FORM fixed  groups, respectively (NS).","[{'ForeName': 'Birsen Pinar', 'Initials': 'BP', 'LastName': 'Yildiz', 'Affiliation': 'Department of Pulmonary Medicine, Yedikule Research and Training Center for Chest Diseases and Thoracic Surgery, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Bayraktaroglu', 'Affiliation': 'Department of Pulmonary Medicine, Yedikule Research and Training Center for Chest Diseases and Thoracic Surgery, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Gunen', 'Affiliation': 'Department of Chest Diseases and Thoracic Surgery, Sureyyapasa Training and Research Center for Chest Diseases and Thoracic Surgery, Istanbul, Turkey.'}]",Current medical research and opinion,['10.1080/03007995.2019.1654722']
1462,31418585,Abaloparatide in patients with mild or moderate renal impairment: results from the ACTIVE phase 3 trial.,"Objective:  To evaluate, post hoc, the efficacy and safety of abaloparatide by degree of renal impairment. Methods:  ACTIVE was a phase 3, 18-month, randomized, double-blind, active-comparator, placebo-controlled study of postmenopausal women with osteoporosis who received subcutaneous abaloparatide 80 µg, placebo, or open-label teriparatide 20 µg daily. Patients with serum creatinine >2.0 mg/dL or 1.5-2.0 mg/dL with an estimated glomerular filtration rate (eGFR) <37 mL/min, calculated by Cockcroft-Gault formula, were excluded. Results:  At baseline, 660 patients had eGFR ≥90 mL/min, 1276 had 60 to ˂90 mL/min, and 527 had <60 mL/min. Older age and lower T-scores were associated with greater renal impairment. Among renal-function subgroups, there were no meaningful changes in bone mineral density, fracture risk reduction, or overall incidence of treatment-emergent adverse events in the active-treatment arms. Anemia, nausea, hypercalcemia, and upper-respiratory-tract infection tended to be more frequent with increasing renal impairment. Hypercalcemia measured by albumin-adjusted serum calcium occurred significantly less frequently with abaloparatide than teriparatide in patients with eGFR <60 mL/min (3.6% versus 10.9%;  p  = .008) and in the overall ACTIVE safety population (3.4% versus 6.4%;  p  = .006). Computed tomography scans in 376 patients revealed no evidence of increased renal calcification. Conclusion:  Increased exposure to abaloparatide and teriparatide in patients with renal impairment led to no meaningful differences in efficacy or safety. These results support the use of abaloparatide without dosage adjustment in patients with renal impairment, provided those with severe renal impairments are monitored for adverse events.",2019,"Among renal-function subgroups, there were no meaningful changes in bone mineral density, fracture risk reduction, or overall incidence of treatment-emergent adverse events in the active-treatment arms.","['patients with renal impairment', '376 patients', 'Patients with serum creatinine >2.0\u2009mg/dL or 1.5-2.0\u2009mg/dL with an estimated glomerular filtration rate (eGFR) <37\u2009mL/min, calculated by Cockcroft-Gault formula, were excluded', 'patients with mild or moderate renal impairment', 'postmenopausal women with osteoporosis who received']","['teriparatide', 'Abaloparatide', 'placebo', 'abaloparatide and teriparatide', 'subcutaneous abaloparatide 80\u2009µg, placebo, or open-label teriparatide 20\u2009µg daily', 'Computed tomography scans']","['efficacy or safety', 'Anemia, nausea, hypercalcemia, and upper-respiratory-tract infection', 'bone mineral density, fracture risk reduction, or overall incidence of treatment-emergent adverse events', 'renal calcification', 'renal impairment', 'Hypercalcemia measured by albumin-adjusted serum calcium']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C3811844'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C2924627', 'cui_str': 'Cockcroft-Gault formula'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}]",660.0,0.224441,"Among renal-function subgroups, there were no meaningful changes in bone mineral density, fracture risk reduction, or overall incidence of treatment-emergent adverse events in the active-treatment arms.","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Bilezikian', 'Affiliation': 'College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Hattersley', 'Affiliation': 'Research & Development, Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Bruce H', 'Initials': 'BH', 'LastName': 'Mitlak', 'Affiliation': 'Research & Development, Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Ming-Yi', 'Initials': 'MY', 'LastName': 'Hu', 'Affiliation': 'Research & Development, Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Lorraine A', 'Initials': 'LA', 'LastName': 'Fitzpatrick', 'Affiliation': 'Research & Development, Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dabrowski', 'Affiliation': 'Research & Development, Radius Health, Inc, Waltham, MA, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Miller', 'Affiliation': 'Colorado Center for Bone Research at Panorama Orthopedics and Spine Center, Golden, CO, USA.'}, {'ForeName': 'Socrates E', 'Initials': 'SE', 'LastName': 'Papapoulos', 'Affiliation': 'Center for Bone Quality, Leiden University Medical Center, Leiden, The Netherlands.'}]",Current medical research and opinion,['10.1080/03007995.2019.1656955']
1463,31585686,Examining patterns of dose response for clients who do and do not complete cognitive processing therapy.,"Trauma-focused therapies, including Cognitive Processing Therapy (CPT; Resick et al., 2016), are effective at reducing clients' PTSD symptoms. A limitation to these treatments, however, is client completion of them. The current study examined temporal patterns of treatment non-completion and the relationships among non-completion, PTSD, and overall mental health functioning outcomes, among clients in a randomized controlled CPT implementation trial. Two models of symptom change were tested: 1) dose-effect model (i.e., clients uniformly improve with additional sessions at a negatively accelerating rate); and 2) the good-enough level model (i.e., clients remain in therapy until they have achieved sufficient improvement, thus clients who attend fewer sessions improve at quicker rates). Results indicated that 42% of clients did not complete treatment, with most discontinuing between sessions two and five. Data did not fit the dose-effect or good-enough level model. Rather, clients who improved at a greater rate in their PTSD symptoms and overall mental health functioning attended more sessions. The average client had the best outcomes when they completed all 12 sessions. Identifying clients who may be at risk for discontinuing treatment, and making a concerted effort toward retaining them, is imperative to reduce non-completion rates and ultimately improve client outcomes.",2019,"Rather, clients who improved at a greater rate in their PTSD symptoms and overall mental health functioning attended more sessions.",['clients who do and do not complete cognitive processing therapy'],[],['PTSD symptoms and overall mental health functioning'],"[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0194681,"Rather, clients who improved at a greater rate in their PTSD symptoms and overall mental health functioning attended more sessions.","[{'ForeName': 'Samantha C', 'Initials': 'SC', 'LastName': 'Holmes', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, United States; University of Akron, Department of Psychology, United States.'}, {'ForeName': 'Clara M', 'Initials': 'CM', 'LastName': 'Johnson', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, United States.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Suvak', 'Affiliation': 'Suffolk University, Department of Psychology, United States.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Sijercic', 'Affiliation': 'Ryerson University, Department of Psychology, Canada.'}, {'ForeName': 'Candice M', 'Initials': 'CM', 'LastName': 'Monson', 'Affiliation': 'Ryerson University, Department of Psychology, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Wiltsey Stirman', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, United States; Stanford University, Department of Psychiatry and Behavioral Sciences, United States. Electronic address: sws1@stanford.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102120']
1464,31136460,STRICT POSTURING WITH OR WITHOUT BILATERAL PATCHING FOR POSTERIOR VITREOUS DETACHMENT-RELATED VITREOUS HEMORRHAGE.,"PURPOSE


To determine whether bilateral patching with posturing is superior to posturing alone in visualizing the superior retina in suspected posterior vitreous detachment (PVD)-related vitreous hemorrhage (VH).
METHODS


Prospective randomized controlled trial: 80 patients with fundus-obscuring VH due to suspected retinal tear were randomized to strict posturing and bilateral patching overnight (Treatment A, 40 patients) or posturing (Treatment B, 40 patients).
PRIMARY OUTCOME


Visualization of ≥4 clock hours superior retina.
SECONDARY OUTCOME MEASURES


laser treatment, vitrectomy rate, and retinal detachment within 12 months.
RESULTS


Intention-to-treat analysis: In 38/40 (95%) with Treatment A and 32/40 (80%) with Treatment B, the confirmed diagnosis was PVD-related VH. Visibility of the superior retina for all patients: 29/40 (73%) after Treatment A and 21/40 (53%) after Treatment B (P = 0.07). Subgroup analysis for confirmed PVD-related VH; visibility of the superior retina: 29/38 (76%) after Treatment A and 15/32 (47%) after Treatment B (P = 0.01). In subgroup analysis, vitrectomy rate within 12 months was 61% (Treatment A) and 53% (Treatment B) (P = 0.63). Retinal detachment: eight patients after each treatment.
CONCLUSION


In patients with suspected PVD-related VH, overnight bilateral patching was not superior to posturing alone in superior retina visualization, but in a post-hoc analysis of patients with confirmed PVD-related VH, bilateral patching was superior.",2020,Visibility of the superior retina for all patients: 29/40 (73%) after Treatment A and 21/40 (53%) after Treatment B (P = 0.07).,"['Retinal detachment: eight patients after each treatment', 'suspected posterior vitreous detachment (PVD)-related vitreous hemorrhage (VH', '80 patients with fundus-obscuring VH due to suspected retinal tear']",['strict posturing and bilateral patching overnight'],"['laser treatment, vitrectomy rate, and retinal detachment within 12 months', 'vitrectomy rate', 'Visualization of ≥4 clock hours superior retina', 'Visibility of the superior retina']","[{'cui': 'C0035305', 'cui_str': 'Retinal Detachment'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0423361', 'cui_str': 'Posterior Vitreous Detachment'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0042909', 'cui_str': 'Vitreous Hemorrhage'}, {'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0035321', 'cui_str': 'Retinal Dialyses'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0035305', 'cui_str': 'Retinal Detachment'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0035298', 'cui_str': 'Retina'}]",80.0,0.16545,Visibility of the superior retina for all patients: 29/40 (73%) after Treatment A and 21/40 (53%) after Treatment B (P = 0.07).,"[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'van Etten', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Koen A', 'Initials': 'KA', 'LastName': 'van Overdam', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Reyniers', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Veckeneer', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Koorosh', 'Initials': 'K', 'LastName': 'Faridpooya', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'René J', 'Initials': 'RJ', 'LastName': 'Wubbels', 'Affiliation': 'Rotterdam Ophthalmic Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Manning', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Ellen C', 'Initials': 'EC', 'LastName': 'La Heij', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'van Meurs', 'Affiliation': 'Department of Vitreoretinal Surgery, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002561']
1465,30705040,Ziv-aflibercept versus bevacizumab administration prior to diabetic vitrectomy: a randomised and controlled trial.,"PURPOSE


To compare the effectiveness of intravitreal ziv-aflibercept (IVZ) to intravitreal bevacizumab (IVB) administered preoperatively to patients undergoing pars plana vitrectomy (PPV) for severe manifestations of proliferative diabetic retinopathy (PDR).
DESIGN


Randomised clinical trial (RCT).
METHODS


Two hundred and six patients with PDR-related complications requiring PPV were randomised into one of two treatment groups: Group A received IVZ (1.25 mg/0.05 mL) 1-10 days before PPV, while Group B received IVB (1.25 mg/0.05 mL) 1-10 days before PPV. The primary outcome was best-corrected visual acuity (BCVA) at 6 months follow-up. Secondary outcome measures were perioperative tractional retinal detachment (TRD) rates, surgical times, intraoperative and postoperative complications and incidence of unplanned PPV during the 6 month study interval.
RESULTS


One hundred and seventy three subjects underwent PPV and completed the 6-month follow-up interval. Group A subjects had better BCVA at 6 months (p=0.0035), shorter surgical times (p=0.0013) and were less likely to have a recurrence of vitreous haemorrhaging in the postoperative period (p=0.0101) when compared with subjects in Group B. There were no significant differences among the treatment groups with regards to baseline characteristics, perioperative TRD development, intraoperative complications and incidence of unplanned PPV during the 6 month study interval.
CONCLUSIONS


This RCT demonstrated better final visual outcomes, shorter operating times and less vitreous haemorrhage recurrences in the postoperative period when subjects received IVZ compared to IVB prior to PPV for the treatment of PDR-related complications.",2019,"There were no significant differences among the treatment groups with regards to baseline characteristics, perioperative TRD development, intraoperative complications and incidence of unplanned PPV during the 6 month study interval.
","['One hundred and seventy three subjects underwent', 'administration prior to diabetic vitrectomy', 'patients undergoing pars', 'Two hundred and six patients with PDR-related complications requiring PPV']","['intravitreal ziv-aflibercept (IVZ) to intravitreal bevacizumab (IVB', 'IVZ', 'plana vitrectomy (PPV', 'PPV', 'Ziv-aflibercept versus bevacizumab']","['recurrence of vitreous haemorrhaging', 'baseline characteristics, perioperative TRD development, intraoperative complications and incidence of unplanned PPV', 'final visual outcomes', 'vitreous haemorrhage recurrences', 'best-corrected visual acuity (BCVA', 'BCVA', 'shorter surgical times', 'perioperative tractional retinal detachment (TRD) rates, surgical times, intraoperative and postoperative complications and incidence of unplanned PPV during the 6\u2009month study interval']","[{'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C3485619', 'cui_str': 'ziv-aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0042909', 'cui_str': 'Vitreous Hemorrhage'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0154828', 'cui_str': 'Traction detachment of retina (disorder)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",206.0,0.163365,"There were no significant differences among the treatment groups with regards to baseline characteristics, perioperative TRD development, intraoperative complications and incidence of unplanned PPV during the 6 month study interval.
","[{'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Aleman', 'Affiliation': 'Instituto de la Visión-Hospital La Carlota, Montemorelos, Nuevo León, México.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Castillo Velazquez', 'Affiliation': 'Instituto de la Visión-Hospital La Carlota, Montemorelos, Nuevo León, México.'}, {'ForeName': 'Sloan W', 'Initials': 'SW', 'LastName': 'Rush', 'Affiliation': 'Panhandle Eye Group, Amarillo, Texas, USA.'}, {'ForeName': 'Ryan B', 'Initials': 'RB', 'LastName': 'Rush', 'Affiliation': 'Instituto de la Visión-Hospital La Carlota, Montemorelos, Nuevo León, México ryanbradfordrush21@hotmail.com.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313313']
1466,31113250,User Satisfaction and Insulin Pump Handling With a Prefilled Insulin Cartridge in Adults and Adolescents With Type 1 Diabetes.,"BACKGROUND


This comparative handling study investigated user satisfaction and insulin pump handling with a prefilled insulin cartridge versus a self-filled insulin reservoir in insulin pump users with type 1 diabetes (T1D).
METHODS


Adult (n = 105) and adolescent (n = 25) participants performed insulin pump preparations using a prefilled insulin cartridge and self-filled insulin reservoir. User satisfaction, insulin pump preparation time, and residual air in infusion set tubing were assessed for each insulin filling method. Post hoc analysis evaluated training time.
RESULTS


User satisfaction scores were statistically significantly different in favor of the prefilled insulin cartridge versus the self-filled insulin reservoir (mean [SD]: overall, 4.0 [0.5] vs 3.3 [0.9]; burden on the user, 1.8 [0.6] vs 2.9 [1.0]; user inconvenience, 2.0 [0.7] vs 2.8 [1.1]; device effectiveness, 3.9 [0.7] vs 3.6 [0.9]; all  P  < .001). Insulin pump preparation time and residual air measurements were significantly different and numerically lower for the prefilled insulin cartridge versus the self-filled insulin reservoir (mean [SD]: preparation time, 124.4 [30.3] vs 237.8 [64.2] seconds,  P  < .001; residual air, 2.3 [26.3] vs 10.0 [63.3] mm,  P  = .007). Training time was shorter with the prefilled insulin cartridge versus the self-filled insulin reservoir (mean [min; max]: 193.1 [36; 453] vs 535.8 [124; 992] seconds).
CONCLUSIONS


Adult and adolescent insulin pump users were more satisfied with the prefilled insulin cartridge versus the self-filled insulin reservoir when preparing an insulin pump. The prefilled insulin cartridge was associated with reduced insulin pump preparation time and reduced training time versus the self-filled insulin reservoir.",2020,The prefilled insulin cartridge was associated with reduced insulin pump preparation time and reduced training time versus the self-filled insulin reservoir.,"['Adults and Adolescents With Type 1 Diabetes', 'insulin pump users with type 1 diabetes (T1D', 'Adult and adolescent insulin pump users', 'Adult (n = 105) and adolescent (n = 25) participants performed']","['Insulin Pump Handling With a Prefilled Insulin Cartridge', 'insulin pump preparations using a prefilled insulin cartridge and self-filled insulin reservoir']","['Insulin pump preparation time and residual air measurements', 'User satisfaction, insulin pump preparation time, and residual air in infusion set tubing', 'User satisfaction scores', 'Training time']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0018578', 'cui_str': 'Handling'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4319642', 'cui_str': 'Cartridge (unit of presentation)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0442537', 'cui_str': 'Reservoir (environment)'}]","[{'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",25.0,0.0436351,The prefilled insulin cartridge was associated with reduced insulin pump preparation time and reduced training time versus the self-filled insulin reservoir.,"[{'ForeName': 'Jitendra', 'Initials': 'J', 'LastName': 'Gupta', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Gitte Schøning', 'Initials': 'GS', 'LastName': 'Fuchs', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jenkins', 'Affiliation': 'UL LLC, Concord, MA, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'van Geel', 'Affiliation': 'UL International (Netherlands) BV, Utrecht, Netherlands.'}, {'ForeName': 'Morten Lind', 'Initials': 'ML', 'LastName': 'Jensen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sparre', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}]",Journal of diabetes science and technology,['10.1177/1932296819848700']
1467,31697873,Elexacaftor-Tezacaftor-Ivacaftor for Cystic Fibrosis with a Single Phe508del Allele.,"BACKGROUND


Cystic fibrosis is caused by mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein, and nearly 90% of patients have at least one copy of the Phe508del  CFTR  mutation. In a phase 2 trial involving patients who were heterozygous for the Phe508del  CFTR  mutation and a minimal-function mutation (Phe508del-minimal function genotype), the next-generation CFTR corrector elexacaftor, in combination with tezacaftor and ivacaftor, improved Phe508del CFTR function and clinical outcomes.
METHODS


We conducted a phase 3, randomized, double-blind, placebo-controlled trial to confirm the efficacy and safety of elexacaftor-tezacaftor-ivacaftor in patients 12 years of age or older with cystic fibrosis with Phe508del-minimal function genotypes. Patients were randomly assigned to receive elexacaftor-tezacaftor-ivacaftor or placebo for 24 weeks. The primary end point was absolute change from baseline in percentage of predicted forced expiratory volume in 1 second (FEV 1 ) at week 4.
RESULTS


A total of 403 patients underwent randomization and received at least one dose of active treatment or placebo. Elexacaftor-tezacaftor-ivacaftor, relative to placebo, resulted in a percentage of predicted FEV 1  that was 13.8 points higher at 4 weeks and 14.3 points higher through 24 weeks, a rate of pulmonary exacerbations that was 63% lower, a respiratory domain score on the Cystic Fibrosis Questionnaire-Revised (range, 0 to 100, with higher scores indicating a higher patient-reported quality of life with regard to respiratory symptoms; minimum clinically important difference, 4 points) that was 20.2 points higher, and a sweat chloride concentration that was 41.8 mmol per liter lower (P<0.001 for all comparisons). Elexacaftor-tezacaftor-ivacaftor was generally safe and had an acceptable side-effect profile. Most patients had adverse events that were mild or moderate. Adverse events leading to discontinuation of the trial regimen occurred in 1% of the patients in the elexacaftor-tezacaftor-ivacaftor group.
CONCLUSIONS


Elexacaftor-tezacaftor-ivacaftor was efficacious in patients with cystic fibrosis with Phe508del-minimal function genotypes, in whom previous CFTR modulator regimens were ineffective. (Funded by Vertex Pharmaceuticals; VX17-445-102 ClinicalTrials.gov number, NCT03525444.).",2019,"Adverse events leading to discontinuation of the trial regimen occurred in 1% of the patients in the elexacaftor-tezacaftor-ivacaftor group.
","['403 patients', 'patients 12 years of age or older with cystic fibrosis with Phe508del-minimal function genotypes', 'patients who were heterozygous for the Phe508del  CFTR  mutation and a minimal-function mutation (Phe508del-minimal function genotype', 'patients with cystic fibrosis with Phe508del-minimal function genotypes']","['Elexacaftor-Tezacaftor-Ivacaftor', 'elexacaftor-tezacaftor-ivacaftor', 'elexacaftor-tezacaftor-ivacaftor or placebo', 'placebo', 'Elexacaftor-tezacaftor-ivacaftor']","['sweat chloride concentration', 'rate of pulmonary exacerbations', 'absolute change from baseline in percentage of predicted forced expiratory volume', 'adverse events', 'quality of life', 'Cystic Fibrosis Questionnaire-Revised']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]","[{'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",403.0,0.366025,"Adverse events leading to discontinuation of the trial regimen occurred in 1% of the patients in the elexacaftor-tezacaftor-ivacaftor group.
","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Middleton', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Mall', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Dřevínek', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Larry C', 'Initials': 'LC', 'LastName': 'Lands', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'McKone', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Polineni', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Bonnie W', 'Initials': 'BW', 'LastName': 'Ramsey', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Taylor-Cousar', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tullis', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Vermeulen', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Gautham', 'Initials': 'G', 'LastName': 'Marigowda', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'McKee', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Moskowitz', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Nair', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Savage', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Simard', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waltz', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Fengjuan', 'Initials': 'F', 'LastName': 'Xuan', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Rowe', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Raksha', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1908639']
1468,29314705,Effect of enhanced homestead food production and aquaculture on dietary intakes of women and children in rural Cambodia: A cluster randomized controlled trial.,"The Cambodian diet is low in nutrient-dense animal-source foods. Enhanced homestead food production (EHFP) and aquaculture, which increase availability of nutrient-dense foods, are promising interventions to improve dietary intake. This study examined the effect of EHFP with or without aquaculture on dietary intake and prevalence of inadequate intake of select nutrients among women and children living in rural Cambodia, compared to controls. In a registered, cluster randomized controlled trial in Prey Veng, Cambodia, 10 households in each of 90 villages (n = 900) were randomized by village to receive EHFP, EHFP plus aquaculture, or control. After 22-month intervention, 24-hr dietary recalls (24HRs) were collected from mothers aged 18-50 years (n = 429) and their children aged 6 months-7 years (n = 421), reported by their mothers. Usual intake distributions (generated using 24HRs and repeat 24HRs on a subsample) were used to estimate prevalence of inadequate intake. Compared to controls, women in the EHFP group had significantly higher zinc (+1.0 mg/d) and Vitamin A (+139 retinol activity equivalents/d) intakes, and women in the EHFP plus aquaculture group had significantly higher iron (+2.7 mg/d), Vitamin A (+191 retinol activity equivalents/d), and riboflavin (+0.17 mg/d) intakes. Women in the EHFP plus aquaculture group also had significantly lower prevalence of inadequate iron (-7%, at 10% bioavailability), Vitamin A (-19%), and riboflavin (-17%) intakes, compared to controls. No significant differences in intakes or nutrient adequacy were observed among children or between EHFP and EHFP plus aquaculture groups. The biological importance of the small differences in nutrient intakes among women remains to be established.",2018,"Compared to controls, women in the EHFP group had significantly higher zinc (+1.0 mg/d) and Vitamin A (","['139', 'Prey Veng, Cambodia, 10 households in each of 90 villages (n\xa0=\xa0900', 'mothers aged 18-50\xa0years (n\xa0=\xa0429) and their children aged 6\xa0months-7\xa0years (n\xa0=\xa0421), reported by their mothers', 'women and children living in rural Cambodia, compared to controls', '191', 'women and children in rural Cambodia']","['EHFP', 'EHFP, EHFP plus aquaculture, or control', 'enhanced homestead food production and aquaculture', 'Vitamin A ', 'EHFP with or without aquaculture', 'riboflavin']","['prevalence of inadequate iron', 'retinol activity equivalents/d) intakes', 'dietary intakes', 'intakes or nutrient adequacy', '24-hr dietary recalls (24HRs']","[{'cui': 'C0006797', 'cui_str': 'Khmer Republic'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0206225', 'cui_str': 'Aquaculture'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0033268'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0373720', 'cui_str': 'Vitamin B2'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]",900.0,0.0757317,"Compared to controls, women in the EHFP group had significantly higher zinc (+1.0 mg/d) and Vitamin A (","[{'ForeName': 'Vashti', 'Initials': 'V', 'LastName': 'Verbowski', 'Affiliation': 'Faculty of Land and Food Systems, Department of Human Nutrition, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Zaman', 'Initials': 'Z', 'LastName': 'Talukder', 'Affiliation': 'Helen Keller International, Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Kroeun', 'Initials': 'K', 'LastName': 'Hou', 'Affiliation': 'Helen Keller International, Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Ly', 'Initials': 'L', 'LastName': 'Sok Hoing', 'Affiliation': 'Helen Keller International, Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Michaux', 'Affiliation': 'Faculty of Land and Food Systems, Department of Human Nutrition, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Anderson', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Gibson', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Li', 'Affiliation': 'Collaboration for Outcomes Research and Evaluation, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Larry D', 'Initials': 'LD', 'LastName': 'Lynd', 'Affiliation': 'Collaboration for Outcomes Research and Evaluation, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'McLean', 'Affiliation': 'Faculty of Land and Food Systems, Department of Human Nutrition, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Green', 'Affiliation': 'Faculty of Land and Food Systems, Department of Human Nutrition, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Susan I', 'Initials': 'SI', 'LastName': 'Barr', 'Affiliation': 'Faculty of Land and Food Systems, Department of Human Nutrition, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Maternal & child nutrition,['10.1111/mcn.12581']
1469,31747009,INTELLANCE 2/EORTC 1410 randomized phase II study of Depatux-M alone and with temozolomide vs temozolomide or lomustine in recurrent EGFR amplified glioblastoma.,"BACKGROUND


Depatuxizumab mafodotin (Depatux-M) is a tumor-specific antibody-drug conjugate consisting of an antibody (ABT-806) directed against activated epidermal growth factor receptor (EGFR) and the toxin monomethylauristatin-F. We investigated Depatux-M in combination with temozolomide or as a single agent in a randomized controlled phase II trial in recurrent EGFR amplified glioblastoma.
METHODS


Eligible were patients with centrally confirmed EGFR amplified glioblastoma at first recurrence after chemo-irradiation with temozolomide. Patients were randomized to either Depatux-M 1.25 mg/kg every 2 weeks intravenously, or this treatment combined with temozolomide 150-200 mg/m2 day 1-5 every 4 weeks, or either lomustine or temozolomide. The primary endpoint of the study was overall survival.
RESULTS


Two hundred sixty patients were randomized. In the primary efficacy analysis with 199 events (median follow-up 15.0 mo), the hazard ratio (HR) for the combination arm compared with the control arm was 0.71 (95% CI = 0.50, 1.02; P = 0.062). The efficacy of Depatux-M monotherapy was comparable to that of the control arm (HR = 1.04, 95% CI = 0.73, 1.48; P = 0.83). The most frequent toxicity in Depatux-M treated patients was a reversible corneal epitheliopathy, occurring as grades 3-4 adverse events in 25-30% of patients. In the long-term follow-up analysis with median follow-up of 28.7 months, the HR for the comparison of the combination arm versus the control arm was 0.66 (95% CI = 0.48, 0.93).
CONCLUSION


This trial suggests a possible role for the use of Depatux-M in combination with temozolomide in EGFR amplified recurrent glioblastoma, especially in patients relapsing well after the end of first-line adjuvant temozolomide treatment. (NCT02343406).",2020,"The efficacy of Depatux-M monotherapy was comparable to that of the control arm (HR =1.04, 95%CI","['Eligible were patients with centrally confirmed EGFR amplified glioblastoma at first recurrence after chemo-irradiation with', '260 patients were randomized', 'recurrent EGFRamplified glioblastoma']","['Depatux-M alone and with temozolomide vs temozolomide or lomustine', 'Depatux-M', 'temozolomide', 'Depatux-M monotherapy', '2/EORTC', 'lomustine or temozolomide']","['reversible corneal epitheliopathy', 'hazard ratio (HR', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}]","[{'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",260.0,0.131555,"The efficacy of Depatux-M monotherapy was comparable to that of the control arm (HR =1.04, 95%CI","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Van Den Bent', 'Affiliation': 'Brain Tumor Institute Erasmus Medical Center (MC) Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Eoli', 'Affiliation': 'Department of Neurology, Carlo Besta Institute, Milan, Italy.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Sepulveda', 'Affiliation': 'University Hospital 12 October, Madrid, Spain.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Smits', 'Affiliation': 'Department of Radiology, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Walenkamp', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jean-Sebastian', 'Initials': 'JS', 'LastName': 'Frenel', 'Affiliation': 'Department of Medical Oncology, René Gauducheau Center for Cancer Care, Nantes, France.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Franceschi', 'Affiliation': 'Department of Medical Oncology, Local Health Unit Agency/Scientific Institute for Research, Hospitalization, and Healthcare (AUSL/IRCCS) Neurological Sciences, Bologna, Italy.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Clement', 'Affiliation': 'Department of Medical Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chinot', 'Affiliation': 'Department of Neuro-Oncology, Institute of Neurophysiopathology, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'De Vos', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Whenham', 'Affiliation': 'Department of Medical Oncology, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sanghera', 'Affiliation': 'University Hospitals Birmingham, Birmingham, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Dubbink', 'Affiliation': 'Department of Pathology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'French', 'Affiliation': 'Brain Tumor Institute Erasmus Medical Center (MC) Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Looman', 'Affiliation': 'Abbvie, Chicago, IL USA.'}, {'ForeName': 'Jyotirmoy', 'Initials': 'J', 'LastName': 'Dey', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Abbvie, Chicago, IL USA.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Ansell', 'Affiliation': 'Abbvie, Chicago, IL USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nuyens', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Spruyt', 'Affiliation': 'Brain Tumor Institute Erasmus Medical Center (MC) Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Brilhante', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Coens', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gorlia', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Golfinopoulos', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}]",Neuro-oncology,['10.1093/neuonc/noz222']
1470,31678957,A randomised controlled trial of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia in psychiatric outpatient clinics: study protocol for the J-SUPPORT 1901 (ACCESS) study.,"INTRODUCTION


One of the reasons for the high mortality rate from cancer in people with schizophrenia is delay in diagnosis. Many studies have shown lower cancer screening rates in people with schizophrenia; however, there are no interventions for people with schizophrenia to increase cancer screening. Therefore, we developed a case management (CM) intervention to encourage participation in cancer screening. The purpose of this study was to examine the efficacy of CM to encourage participation in cancer screening for people with schizophrenia, with particular focus on colorectal cancer screening by faecal occult blood testing, compared with usual intervention (UI), namely, municipal public education.
METHODS AND ANALYSIS


This is an individually randomised, parallel group trial with blinded outcome assessments. The participants will be randomly allocated to either the CM plus UI group or UI alone group in a 1:1 ratio using a web-based program at a data management centre. The primary end point of the study is participation in colorectal cancer screening in the year of intervention, which will be assessed based on municipal records.
ETHICS AND DISSEMINATION


This study is performed in accordance with Ethical Guidelines for Medical and Health Research Involving Human Subjects published by Japan's Ministry of Education, Science, and Technology and the Ministry of Health, Labour, and Welfare and the modified Act on the Protection of Personal Information as well as the Declaration of Helsinki. This study was approved by the institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences and Okayama University Hospital on 23 April 2019 (approval number: RIN1904-003). The findings of this trial will be submitted to an international peer-reviewed journal.
TRIAL REGISTRATION NUMBER


UMIN000036017.",2019,"Many studies have shown lower cancer screening rates in people with schizophrenia; however, there are no interventions for people with schizophrenia to increase cancer screening.","['people with schizophrenia in psychiatric outpatient clinics', 'people with schizophrenia, with particular focus on colorectal cancer screening by faecal occult blood testing, compared with usual intervention (UI), namely, municipal public education', 'institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences and Okayama University Hospital on 23 April 2019 (approval number: RIN1904-003', 'people with schizophrenia']","['CM plus UI group or UI alone group in a 1:1 ratio using a web-based program at a data management centre', 'case management (CM) intervention', 'CM']",['colorectal cancer screening'],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces (procedure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}]","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",,0.10723,"Many studies have shown lower cancer screening rates in people with schizophrenia; however, there are no interventions for people with schizophrenia to increase cancer screening.","[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Neuropsychiatry, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Inagaki', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Shimane University, Izumo, Japan minagaki@med.shimane-u.ac.jp.'}, {'ForeName': 'Taichi', 'Initials': 'T', 'LastName': 'Shimazu', 'Affiliation': 'Division of Prevention, Epidemiology and Prevention Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kodama', 'Affiliation': 'Okayama Psychiatric Medical Center, Okayama, Japan.'}, {'ForeName': 'Ryuhei', 'Initials': 'R', 'LastName': 'So', 'Affiliation': 'Okayama Psychiatric Medical Center, Okayama, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Matsushita', 'Affiliation': 'Zikei Hospital, Okayama, Japan.'}, {'ForeName': 'Yusaku', 'Initials': 'Y', 'LastName': 'Yoshimura', 'Affiliation': 'Zikei Hospital, Okayama, Japan.'}, {'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Horii', 'Affiliation': 'Zikei Hospital, Okayama, Japan.'}, {'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Fujimori', 'Affiliation': 'Division of Health Care Research, Behavioral Sciences and Survivorship Research Group and Division of Cohort Consortium Research, Epidemiology and Prevention Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Division of Screening Assessment and Management, Epidemiology and Prevention Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nakaya', 'Affiliation': 'Department of Health Sciences, Saitama Prefectural University, Koshigaya, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Kakeda', 'Affiliation': 'Department of Neuropsychiatry, Kochi Medical School, Kochi University, Nankoku, Japan.'}, {'ForeName': 'Tempei', 'Initials': 'T', 'LastName': 'Miyaji', 'Affiliation': 'Department of Clinical Trial Data Management, Tokyo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Hinotsu', 'Affiliation': 'Department of Biostatistics, Sapporo Medical University, Sapporo, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Gastroenterology, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital and Behavioral Sciences and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Yamada', 'Affiliation': 'Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-032955']
1471,31141115,Comparison of Cinematic Rendering and Computed Tomography for Speed and Comprehension of Surgical Anatomy.,"Importance


Three-dimensional (3-D) volume rendering has been shown to improve visualization in general surgery. Cinematic rendering (CR), a novel 3-D visualization technology for postprocessing of computed tomographaphy (CT) images, provides photorealistic images with the potential to improve visualization of anatomic details.
Objective


To determine the value of CR for the comprehension of the surgical anatomy.
Design, Setting, and Participants


This preclinical, randomized, 2-sequence crossover study was conducted from February to November 1, 2018, at University Hospital of Erlangen, Germany. The 40 patient cases were evaluated by 18 resident and attending surgeons using a prepared set of CT and CR images. The patient cases were randomized to 2 assessment sequences (CR-CT and CT-CR). During each assessment period, participants answered 1 question per case that addressed crucial issues of anatomic understanding, preoperative planning, and intraoperative strategies. After a washout period of 2 weeks, case evaluations were crossed over to the respective second image modality.
Main Outcomes and Measures


The primary outcome measure was the correctness of answers. Secondary outcome was the time needed to answer.
Results


The mean (SD) interperiod differences for the percentage of correct answers in the CR-CT sequence (8.5% [7.0%]) differed significantly from those in the CT-CR sequence (-13.1% [6.3%]) (P < .001). The mean (SD) interperiod differences for the time spent to answer the questions in the CR-CT sequence (-18.3 [76.9] seconds) also differed significantly from those in the CT-CR sequence (52.4 [88.5] seconds) (P < .001). Subgroup analysis revealed that residents as well as attending physicians benefitted from CR visualization. Analysis of the case assessment questionnaire showed that CR added significant value to the comprehension of the surgical anatomy (overall mean [SD] score, 4.53 [0.75]). No carryover or period effects were observed.
Conclusions and Relevance


The visualization with CR allowed a more correct and faster comprehension of the surgical anatomy compared with conventional CT imaging, independent of level of surgeon experience. Therefore, CR may assist general surgeons with preoperative preparation and intraoperative guidance.",2019,"The visualization with CR allowed a more correct and faster comprehension of the surgical anatomy compared with conventional CT imaging, independent of level of surgeon experience.","['February to November 1, 2018, at University Hospital of Erlangen, Germany', '40 patient cases were evaluated by 18 resident and attending surgeons using a prepared set of CT and CR images']","['Cinematic Rendering and Computed Tomography', 'Cinematic rendering (CR']","['CR-CT sequence', 'correctness of answers', 'time needed to answer']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",,0.0666622,"The visualization with CR allowed a more correct and faster comprehension of the surgical anatomy compared with conventional CT imaging, independent of level of surgeon experience.","[{'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'Elshafei', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Binder', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Justus', 'Initials': 'J', 'LastName': 'Baecker', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Brunner', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Uder', 'Affiliation': 'Institute of Radiology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Georg F', 'Initials': 'GF', 'LastName': 'Weber', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grützmann', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Krautz', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}]",JAMA surgery,['10.1001/jamasurg.2019.1168']
1472,31111862,"Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels: A Prespecified Analysis of the Randomized BIO-RESORT Trial.","Importance


Stenting small-vessel lesions has an increased adverse cardiovascular event risk. Very thin-strut or ultrathin-strut drug-eluting stents might reduce this risk, but data are scarce.
Objective


To assess the outcome of all-comer patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents.
Design


This is a prespecified substudy of the Comparison of Biodegradable Polymer and Durable Polymer Drug-eluting Stents in an All Comers Population (BIO-RESORT) trial, an investigator-initiated, randomized, patient-blinded comparative clinical drug-eluting stent trial. Patients treated with ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents were enrolled from December 2012 to August 2015. This multicenter trial was conducted in 4 Dutch centers for cardiac intervention. Of all 3514 all-comer BIO-RESORT participants, 1506 patients with treatment in at least 1 small-vessel lesion (reference vessel <2.5 mm) were included. Data were analyzed between September 2018 and February 2019.
Main Outcomes and Measures


Target lesion failure at 3-year follow-up, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization, analyzed by Kaplan-Meier methods.
Results


In 1452 of 1506 participants (96.4%) (1057 men [70.2%]; 449 women [29.8%]; mean [SD] age, 64.3 [10.4] years), follow-up was available. Target lesion failure occurred in 36 of 525 patients (7.0%) treated with sirolimus-eluting stents, 46 of 496 (9.5%) with everolimus-eluting stents, and 48 of 485 (10.0%) with zotarolimus-eluting stents (sirolimus-eluting vs zotarolimus-eluting hazard ratio [HR], 0.68; 95% CI, 0.44-1.05; P = .08; everolimus-eluting vs zotarolimus-eluting HR, 0.93; 95% CI, 0.62-1.39; P = .72). There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02). In the everolimus-eluting stents, the revascularization rate was 4.0% (vs zotarolimus-eluting, HR, 0.74; 95% CI, 0.41-1.34; P = .31). There was no significant between-stent difference in cardiac death, target vessel myocardial infarction, or stent thrombosis.
Conclusions and Relevance


Patients stented in small coronary vessels experienced fewer repeated revascularizations if treated with ultrathin-strut sirolimus-eluting stents vs previous generation thin strut zotarolimus-eluting stents. Further research is required to evaluate the potential effect of particularly thin stent struts.
Trial Registration


ClinicalTrials.gov identifier: NCT01674803.",2019,"There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02).","['Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels', 'In 1452 of 1506 participants (96.4%) (1057 men [70.2%]; 449 women [29.8%]; mean [SD] age, 64.3 [10.4] years), follow-up was available', '1506 patients with treatment in at least 1 small-vessel lesion (reference vessel <2.5 mm) were included', '4 Dutch centers for cardiac intervention', 'patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents']","['Biodegradable Polymer and Durable Polymer Drug-eluting Stents', 'ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents']","['revascularization rate', 'cardiac death, target vessel myocardial infarction, or stent thrombosis', 'target lesion revascularization rate', 'target lesion revascularizations', 'Main Outcomes and Measures\n\n\nTarget lesion failure at 3-year follow-up, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization, analyzed by Kaplan-Meier methods', 'Target lesion failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0010075', 'cui_str': 'Coronary Vessels'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0443202', 'cui_str': 'Dissimilar (qualifier value)'}, {'cui': 'C0457591', 'cui_str': 'Type of drug (attribute)'}]","[{'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1700035', 'cui_str': 'zotarilumus'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",1506.0,0.0929333,"There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02).","[{'ForeName': 'Rosaly A', 'Initials': 'RA', 'LastName': 'Buiten', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Eline H', 'Initials': 'EH', 'LastName': 'Ploumen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zocca', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Carine J M', 'Initials': 'CJM', 'LastName': 'Doggen', 'Affiliation': 'Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Liefke C', 'Initials': 'LC', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Marlies M', 'Initials': 'MM', 'LastName': 'Kok', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Danse', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'Department of Cardiology, Haga Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Scholte', 'Affiliation': 'Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Frits H A F', 'Initials': 'FHAF', 'LastName': 'de Man', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Gerard C M', 'Initials': 'GCM', 'LastName': 'Linssen', 'Affiliation': 'Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}]",JAMA cardiology,['10.1001/jamacardio.2019.1776']
1473,31107327,Does Three-dimensional Printing Plus Pedicle Guider Technology in Severe Congenital Scoliosis Facilitate Accurate and Efficient Pedicle Screw Placement?,"BACKGROUND


Three-dimensional (3-D) printing offers the opportunity to create patient-specific guides for pedicle screw placement based on CT-generated models. This technology might allow for more-accurate placement of pedicle screws in patients with severe congenital scoliosis who have rotated vertebrae and small pedicles, but to our knowledge, this premise has not been tested.
QUESTIONS/PURPOSES


(1) Is the use of 3-D printing and pedicle guider technology as or more accurate than the use of the freehand technique for pedicle-screw placement in patients with severe congenital scoliosis? (2) Does surgical time differ with the use of these guiders? (3) Are complications less common in patients treated with this new approach to pedicle-screw placement?
METHODS


A prospective controlled study was conducted of patients with severe congenital scoliosis (major curve ≥ 90°) from June 2016 to June 2018. During this period, we treated 93 patients with congenital scoliosis; 32 had severe scoliosis with a major curve ≥ 90°. The patients were divided into a pedicle guider group (n = 15) and a control group (n = 17) based on their willingness to use pedicle guider technology, which was considered a research technology. With the numbers available, there were no between-group differences in terms of age, sex, BMI, or parameters related to curve severity or flexibility, and all patients in both groups had severe curves. Preoperative and postoperative low-dose CT scans were performed in the two groups. In the pedicle guider group, custom software was used to design the pedicle guider, and a 3-D printer was used to print a physical spinal model and pedicle guiders. The pedicle guiders were tested on the surface of the physical spinal model before surgery to ensure proper fit, and then used to assist pedicle screw placement during surgery. A total of 244 screws were implanted with the help of 127 pedicle guiders (254 guiding tunnels) during surgery in the PG group. Five predesigned pedicle guiders were abandoned due to an unstable match, and the success rate of assisted screw placement using a pedicle guider was 96% (244 of 254). The freehand technique was used in the control group, which relied on anatomic localization to place pedicle screws. The accuracy of pedicle screw placement was evaluated with CT scans, which revealed whether screws had broken through the pedicle cortex. We compared the groups in terms of accuracy (defined as unanticipated breaches less than 2 mm), surgical time, time to place pedicle screws, and screw-related complications.
RESULTS


A higher proportion of the screws placed using pedicle guider technology were positioned accurately than were in the control group (93% [227 of 244] versus 78% [228 of 291]; odds ratio, 3.69 [95% CI, 2.09-6.50]; p<0.001). With pedicle guider use, operative time (296 ± 56 versus 360 ± 74; 95% CI, -111 to -17; p = 0.010), time to place all screws (92 ± 17 versus 118 ± 21; 95% CI, -39 to -12; p = 0.001), and mean time to place one screw (6 ± 1 versus 7 ± 1; 95% CI, -2 to 0; p = 0.011) decreased. One patient in the pedicle guider group and four in the control group experienced screw-related complications; the sample sizes and small number of complications precluded statistical comparisons.
CONCLUSIONS


In this small, preliminary study, we showed that the accuracy of the surgical technique using spinal 3-D printing combined with pedicle guider technology in patients with severe congenital scoliosis was higher than the accuracy of the freehand technique. In addition, the technique using pedicle guider technology appeared to shorten operative time. If these findings are confirmed in a larger study, pedicle guider technology may be helpful for situations in which intraoperative CT or O-arm navigation is not available.
LEVEL OF EVIDENCE


Level II, therapeutic study.",2019,"With the numbers available, there were no between-group differences in terms of age, sex, BMI, or parameters related to curve severity or flexibility, and all patients in both groups had severe curves.","['93 patients with congenital scoliosis; 32 had severe scoliosis with a major curve ≥ 90°', 'patients with severe congenital scoliosis (major curve ≥ 90°) from June 2016 to June 2018', 'A total of 244 screws were implanted with the help of 127 pedicle guiders (254 guiding tunnels) during surgery in the PG group', 'patients with severe congenital scoliosis', 'patients with severe congenital scoliosis who have rotated vertebrae and small pedicles']","['spinal 3-D printing combined with pedicle guider technology', 'freehand technique for pedicle-screw placement']","['accuracy of pedicle screw placement', 'surgical time, time to place pedicle screws, and screw-related complications', 'operative time', 'screw-related complications', 'time to place all screws', 'mean time to place one screw']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0559260', 'cui_str': 'Congenital scoliosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0456605', 'cui_str': 'Pedicle (substance)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231458', 'cui_str': 'Rotated (qualifier value)'}, {'cui': 'C0549207', 'cui_str': 'Vertebra'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}]","[{'cui': 'C3849992', 'cui_str': '3-Dimensional Printing'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0456605', 'cui_str': 'Pedicle (substance)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",244.0,0.034974,"With the numbers available, there were no between-group differences in terms of age, sex, BMI, or parameters related to curve severity or flexibility, and all patients in both groups had severe curves.","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'M. Luo, W. Wang, N. Yang, L. Xia, Institute of Spinal Deformity, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, PR China.'}, {'ForeName': 'Wengang', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ningning', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000739']
1474,31107324,Can the QuickDASH PROM be Altered by First Completing the Tasks on the Instrument?,"BACKGROUND


Health systems and payers use patient-reported outcome measures (PROMs) to inform quality improvement and value-based payment models. Although it is known that psychosocial factors and priming influence PROMs, we sought to determine the effect of having patients complete functional tasks before completing the PROM questionnaire, which has not been extensively evaluated.
QUESTIONS/PURPOSES


(1) Will QuickDASH scores change after patients complete the tasks on the questionnaire compared with baseline QuickDASH scores? (2) Will the change in QuickDASH score in an intervention (task completion) group be different than that of a control group? (3) Will a higher proportion of patients in the intervention group than those in the control group improve their QuickDASH scores by greater than a minimally clinically important difference (MCID) of 14 points?
METHODS


During a 2-month period, 140 patients presented at our clinic with a hand or upper-extremity problem. We approached patients who spoke and read English and were 18 years old or older. One hundred thirty-two (94%) patients met the inclusion criteria and agreed to participate (mean ± SD age, 52 ± 17 years; 60 men [45%], 72 women [55%]; 112 in the intervention group [85%] and 20 in the control group [15%]). First, all patients who completed the QuickDASH PROM (at baseline) were recruited for participation. Intervention patients completed the functional tasks on the QuickDASH and completed a followup QuickDASH. Control patients were recruited and enrolled after the intervention group completed the study. Participants in the control group completed the QuickDASH at baseline and a followup QuickDASH 5 minutes after (the time required to complete the functional tasks). Paired and unpaired t-tests were used to evaluate the null hypotheses that (1) QuickDASH scores for the intervention group would not change after the tasks on the instrument were completed and (2) the change in QuickDASH score in the intervention group would not be different than that of the control group (p < 0.05). To evaluate the clinical importance of the change in score after tasks were completed, we recorded the number of patients with a change greater than an MCID of 14 points on the QuickDASH. Fisher's exact test was used to evaluate the difference between groups in those reaching an MCID of 14.
RESULTS


In the intervention group, the QuickDASH score decreased after the intervention (39 ± 24 versus 25 ± 19; mean difference, -14 points [95% CI, 12 to 16]; p < 0.001). The change in QuickDASH scores was greater in the intervention group than that in the control group (-14 ± 11 versus -2 ± 9 [95% CI, -17 to -7]; p < 0.001). A larger proportion of patients in the intervention group than in the control group demonstrated an improvement in QuickDASH scores greater than the 14-point MCID ([43 of 112 [38%] versus two of 20 [10%]; odds ratio, 5.4 [95% CI, 1 to 24%]; p = 0.019).
CONCLUSIONS


Reported disability can be reduced, thereby improving PROMs, if patients complete QuickDASH tasks before completing the questionnaire. Modifiable factors that influence PROM scores and the context in which scores are measured should be analyzed before PROMs are broadly implemented into reimbursement models and quality measures for orthopaedic surgery. Standardizing PROM administration can limit the influence of context, such as task completion, on outcome scores and should be used in value-based payment models.
LEVEL OF EVIDENCE


Level II, therapeutic study.",2019,"A larger proportion of patients in the intervention group than in the control group demonstrated an improvement in QuickDASH scores greater than the 14-point MCID ([43 of 112 [38%] versus two of 20 [10%]; odds ratio, 5.4 [95% CI, 1 to 24%]; p = 0.019).
","['One hundred thirty-two (94%) patients met the inclusion criteria and agreed to participate (mean ± SD age, 52 ± 17 years; 60 men [45%], 72 women [55%]; 112 in the intervention group [85%] and 20 in the control group [15', 'Control patients were recruited and enrolled after the intervention group completed the study', '140 patients presented at our clinic with a hand or upper-extremity problem', 'patients who completed the QuickDASH PROM (at baseline) were recruited for participation', 'patients with a change greater than an MCID of 14 points on the QuickDASH', 'patients who spoke and read English and were 18 years old or older']",['QuickDASH'],"['QuickDASH score', 'null hypotheses that (1) QuickDASH scores', 'QuickDASH scores', 'functional tasks', 'change in QuickDASH scores']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C1277154', 'cui_str': 'Reads English'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456148', 'cui_str': 'Null (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",140.0,0.0500028,"A larger proportion of patients in the intervention group than in the control group demonstrated an improvement in QuickDASH scores greater than the 14-point MCID ([43 of 112 [38%] versus two of 20 [10%]; odds ratio, 5.4 [95% CI, 1 to 24%]; p = 0.019).
","[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Shapiro', 'Affiliation': 'L. M. Shapiro, S. L. Eppler, R. N. Kamal, Stanford University, VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford, CA, USA A. H. S. Harris , Stanford School of Medicine/VA Palo Alto Healthcare System, Department of Surgery, Stanford, CA, USA.'}, {'ForeName': 'Alex H S', 'Initials': 'AHS', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Eppler', 'Affiliation': ''}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Kamal', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000731']
1475,31116848,The role of sham continuous positive airway pressure as a placebo in controlled trials: Best Apnea Interventions for Research Trial.,"STUDY OBJECTIVES


The main objective of this study was to evaluate the role of sham continuous positive airway pressure (CPAP) compared to conservative medical therapy (CMT) as a control arm in the Best Apnea Interventions for Research (BestAIR) study by assessing differences in subjectively and objectively measured outcomes, adverse events, adherence, and retention rates.
METHODS


BestAIR is a clinical trial aimed to identify important design features for future randomized controlled trials of CPAP. Participants with obstructive sleep apnea were randomized to one of four groups; two control arms (CMT, sham-CPAP) and two active CPAP arms (with and without behavioral interventions). Blood pressure and health-related quality of life outcomes were assessed at baseline, 6 and 12 months. Study outcomes, retention, and adverse event rates were compared between the two control arms. Sham-CPAP adherence and self-efficacy were also compared to active-CPAP adherence (without behavioral intervention).
RESULTS


Our sample included 86 individuals in the control arms and 42 participants in the active-CPAP arm. There were no differences in longitudinal profiles in blood pressure, health-related quality of life outcomes, dropout rates, or adverse events in sham-CPAP group compared to CMT-only group (all ps > 0.05); standardized differences were generally small and with inconsistent directionality across measurements. When compared to active-CPAP, sham-CPAP was associated with 93 fewer minutes/night of usage over 12 months (p = 0.007) and lower outcome expectations (p < 0.05).
CONCLUSION


We observed no evidence of differences in objectively or subjectively measured outcomes with the use of sham-CPAP compared to CMT group. The lower adherence on sham-CPAP and poorer self-efficacy compared to active-CPAP may suggest differences in perceived benefit.
REGISTRATION


NCT01261390 Best Apnea Interventions for Research (BestAIR) www.clinicaltrials.gov.",2019,"There were no differences in longitudinal profiles in blood pressure, health-related quality of life outcomes, dropout rates, or adverse events in sham-CPAP group compared to CMT-only group (all ps > 0.05); standardized differences were generally small and with inconsistent directionality across measurements.","['Participants with obstructive sleep apnea', '86 individuals in the control arms and 42 participants in the active-CPAP arm']","['sham continuous positive airway pressure (CPAP', 'placebo', 'conservative medical therapy (CMT', 'control arms (CMT, sham-CPAP) and two active CPAP arms (with and without behavioral interventions', 'CPAP']","['Blood pressure and health-related quality of life outcomes', 'retention, and adverse event rates', 'blood pressure, health-related quality of life outcomes, dropout rates, or adverse events', 'adverse events, adherence, and retention rates']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.320557,"There were no differences in longitudinal profiles in blood pressure, health-related quality of life outcomes, dropout rates, or adverse events in sham-CPAP group compared to CMT-only group (all ps > 0.05); standardized differences were generally small and with inconsistent directionality across measurements.","[{'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Reid', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston MA.""}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Gleason', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston MA.""}, {'ForeName': 'Jessie P', 'Initials': 'JP', 'LastName': 'Bakker', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston MA.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston MA.""}, {'ForeName': 'Murray A', 'Initials': 'MA', 'LastName': 'Mittleman', 'Affiliation': 'Department of Epidemiology, Harvard University T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston MA.""}]",Sleep,['10.1093/sleep/zsz099']
1476,31116189,"Dental extractions for patients on oral antiplatelet: a within-person randomised controlled trial comparing haemostatic plugs, advanced-platelet-rich fibrin (A-PRF+) plugs, leukocyte- and platelet-rich fibrin (L-PRF) plugs and suturing alone.","PURPOSE


To compare the outcome of tooth extractions in patients taking oral antithrombotic without reducing their dose. Four different interventions were compared within the same patient: suturing alone (control group), suturing plus a haemostatic plug, suturing plus advanced-platelet-rich fibrin (A-PRF+) plug, and suturing plus leukocyte- and platelet-rich fibrin (L-PRF) plug into the socket.
MATERIALS AND METHODS


Forty patients, taking oral antiplatelet agents, requiring the extraction of at least four non-adjacent teeth were selected for the study. After extractions the sockets were randomly allocated to suturing alone (control group), suturing plus haemostatic plug (HAEM), suturing plus advanced-platelet-rich fibrin (A-PRF+) plug, and suturing plus leukocyte- and platelet-rich fibrin (L-PRF) plug into the socket without reducing the dose of oral antiplatelets according to a split-mouth design. Outcome measures were complications, time to complete each procedure, postoperative bleeding, costs of the materials, patient preference and a wound healing index recorded 1 and 2 weeks postextraction by blinded assessors.
RESULTS


Two weeks after extraction no patient dropped out and no complication was reported. The average time to complete suturing after tooth extractions was: 1.0 ± 0.00 minutes at control sites, 1.5 ± 0.41 at HAEM sites, 2.8 ± 0.61 at A-PRF+ sites, and 2.8 ± 0.56 at L-PRF sites, the difference being statistically significant between each pairwise comparison except A-PRF+ vs L-PRF. Postoperative bleeding 30 minutes after extractions was present at 8, 5, 1 and 2 sites for control, HAEM, A-PRF+ and L-PRF sites, respectively. A-PRF showed statistically significantly less bleeding compared to the control group (odds ratio = 0.1 (95% CI [0.01;0.86]; P < 0.0361). In all cases bleeding was moderate in nature and not severe. One week after extractions the mean wound healing index was 1.05 ± 0.60 for control, 1.18 ± 0.59 for HAEM, 1.00 ± 0.68 for A-PRF+ and 0.95 ± 0.50 for L-PRF sites. No statistically significant difference was detected across groups (P = 0.633). Two weeks after extractions the mean wound healing index was 0.33 ± 0.53 for control, 0.43 ± 0.50 for HAEM, 0.25 ± 0.49 for A-PRF+ and 0.15 ± 0.36 for L-PRF sites. No statistically significant difference across groups was detected (P = 0.255). One week after extractions, nine patients preferred control sites, eight HAEM, ten A-PRF+, four L-PRF and nine had no preference. No statistically significant differences were detected for control sites (P = 0.6779), HAEM (P = 1.0000), A-PRF+ (P = 0.4055) and L-PRF (P = 0.1472). Two weeks after extractions five patients preferred control sites, three HAEM, eight A-PRF+, eight L-PRF and 16 had no preference. No statistically significant differences were detected for control sites (P = 0.8147), HAEM (P = 0.2363), A-PRF+ (P = 0.3488) and L-PRF (P = 0.3488). Costs without counting sutures and blood centrifuges were 0.00, 14.49, 2.44 and 2.44 Euro for control, HAEM, A-PRF+ and L-PRF sites, respectively.
CONCLUSIONS


It may not be necessary to discontinue the use of oral antiplatelets in patients undergoing dental extractions and, when present, the minor statistically significant differences between procedures were not clinically relevant; therefore clinicians can use any of the tested interventions according to their preference, keeping in mind that simple suturing is sufficient and is faster and cheaper, and that A-PRF+ was associated with less postoperative bleeding when compared to suturing alone.",2019,A-PRF showed statistically significantly less bleeding compared to the control group (odds ratio = 0.1,"['patients taking oral antithrombotic without reducing their dose', 'Forty patients, taking oral antiplatelet agents, requiring the extraction of at least four non-adjacent teeth were selected for the study']","['suturing alone (control group), suturing plus a haemostatic plug, suturing plus advanced-platelet-rich fibrin', 'suturing alone (control group), suturing plus haemostatic plug (HAEM), suturing plus advanced-platelet-rich fibrin (A-PRF+) plug, and suturing plus leukocyte- and platelet-rich fibrin', 'haemostatic plugs, advanced-platelet-rich fibrin (A-PRF+) plugs, leukocyte- and platelet-rich fibrin', 'suturing plus leukocyte- and platelet-rich fibrin']","['average time to complete suturing', 'HAEM', 'bleeding', 'Postoperative bleeding', 'mean wound healing index', 'postoperative bleeding', 'Costs without counting sutures and blood centrifuges', 'complications, time to complete each procedure, postoperative bleeding, costs of the materials, patient preference and a wound healing index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet Agents'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0182324', 'cui_str': 'Plug (physical object)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4505052', 'cui_str': 'L-PRF'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0018966', 'cui_str': 'Protoheme'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C0179834', 'cui_str': 'Centrifuge'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}]",,0.0209438,A-PRF showed statistically significantly less bleeding compared to the control group (odds ratio = 0.1,"[{'ForeName': 'Amerigo', 'Initials': 'A', 'LastName': 'Giudice', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Esposito', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bennardo', 'Affiliation': ''}, {'ForeName': 'Ylenia', 'Initials': 'Y', 'LastName': 'Brancaccio', 'Affiliation': ''}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Buti', 'Affiliation': ''}, {'ForeName': 'Leonzio', 'Initials': 'L', 'LastName': 'Fortunato', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1477,31138501,Morphometric Assessment of Resected Femoral Cut Surface in Korean Knees and Its Fitting With Western-Designed Femoral Components.,"BACKGROUND


This study aimed at assessing the morphometry of resected femurs in Korean patients during total knee arthroplasty (TKA) and comparing these measurements with current Western-designed femoral component dimensions.
METHODS


This single-blind, prospective, randomized, controlled trial involved intraoperative measurements for 271 femoral component implantations from 3 contemporary TKA systems, with 2 systems offering narrow sizing options. The difference between femoral component dimensions and the resected surface of distal femur was measured in millimeters at 5 distinct zones.
RESULTS


Overhang of standard femoral component was common in the anterior-medial condyle and anterior-lateral condyle ranging from 50.8% to 99.0% and 21.5% to 88.0%, respectively. With narrow femoral components, the rate of overhang reduced to 21.5%-30.2% and 9.2%-32.1%. Conversely, underhang rates were higher over the anterior flange width, middle medial-lateral and posterior medial-lateral zones. Standard components displayed higher underhang rates at these zones compared to narrow components. The good fit rate for femoral component was low among the 3 systems ranging from 1.0% to 56.0%. System with narrow option sizing increases the underhang rates in males, while improving the component fit among females at similar zones with rate ranging from 5.2% to 52.9%.
CONCLUSION


Currently available TKA implant designs may not provide a perfect match for the distal femoral shape of the Korean population. The availability of implants with standard and narrow options can substantially improve the optimal fitting of femoral components in the Korean population.",2019,The good fit rate for femoral component was low among the 3 systems ranging from 1.0% to 56.0%.,"['271 femoral component implantations from 3 contemporary TKA systems, with 2 systems offering narrow sizing options', 'Korean patients during total knee arthroplasty (TKA']",[],"['femoral component dimensions and the resected surface of distal femur', 'femoral component', 'rate of overhang', 'underhang rates']","[{'cui': 'C0449434', 'cui_str': 'Femoral component (attribute)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]",[],"[{'cui': 'C0449434', 'cui_str': 'Femoral component (attribute)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}]",271.0,0.0755389,The good fit rate for femoral component was low among the 3 systems ranging from 1.0% to 56.0%.,"[{'ForeName': 'Teck S', 'Initials': 'TS', 'LastName': 'Fong', 'Affiliation': 'Department of Orthopaedic Surgery, Putrajaya Hospital, Federal Government Administrative Centre, Putrajaya, Malaysia; Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Seong Chan', 'Initials': 'SC', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Ji Eui', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Eui Soo', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Tae Woo', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Yong Seuk', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.04.061']
1478,30819688,Prospective randomised clinical trial of intravitreal bevacizumab versus triamcinolone in eyes with diabetic macular oedema undergoing cataract surgery: 6-month results.,"AIM


To report the 6-month results of a clinical trial that compared intravitreous bevacizumab (BVB) 1.25 mg versus triamcinolone acetonide (TA) 4 mg when administered as an adjunct during cataract surgery to patients with diabetic macular oedema (DMO).
METHODS


Prospective, double-masked, single-centre (Royal Victorian Eye and Ear Hospital, Melbourne) clinical trial. Patients with visually significant cataract and centre-involving DMO (either current or prior) were randomised (1: 1) to receive either intravitreous BVB 1.25 mg or TA 4 mg at the time of cataract surgery and if required at review. Main outcome measures were changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to the 6-month time point of this 12-month study.
RESULTS


61 eyes of 58 patients were enrolled. At baseline, both groups were similar in terms of BCVA and CMT (p>0.2). At 6 months, there was no significant difference in vision between the groups, with mean letter gain of +21.4 (95% CI +14.5 to +28.4) in the TA group and +17.3 (95% CI +12.1 to +22.6) in the BVB group (p=0.35). The TA group had a significant sustained anatomical improvement at 6 months, with a reduction in CMT (-51.4 µm; 95% CI -98.2 to -4.7) compared with thickening in the BVB group (+15.6 µm; 95% CI -26.4 to +57.7, p=0.04).
CONCLUSIONS


When given as an adjunct to cataract surgery, both TA and BVB improved visual outcomes at 6 months postoperatively. However, only TA resulted in sustained improvement in CMT, with the majority not requiring any further treatment postoperatively.",2019,"At baseline, both groups were similar in terms of BCVA and CMT (p>0.2).","['eyes with diabetic macular oedema undergoing cataract surgery', '61 eyes of 58 patients were enrolled', 'patients with diabetic macular oedema (DMO', 'Patients with visually significant cataract and centre-involving DMO (either current or prior']","['intravitreous bevacizumab (BVB) 1.25', 'triamcinolone acetonide (TA', 'intravitreous BVB 1.25\u2009mg or TA 4\u2009mg at the time of cataract surgery', 'triamcinolone', 'intravitreal bevacizumab']","['vision', 'changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT', 'CMT', 'TA and BVB improved visual outcomes', 'mean letter gain']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517497', 'cui_str': '1.25 (qualifier value)'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]","[{'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",58.0,0.188876,"At baseline, both groups were similar in terms of BCVA and CMT (p>0.2).","[{'ForeName': 'Rathika', 'Initials': 'R', 'LastName': 'Kandasamy', 'Affiliation': 'Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Sophie L', 'Initials': 'SL', 'LastName': 'Rogers', 'Affiliation': 'Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Sukhpal Singh', 'Initials': 'SS', 'LastName': 'Sandhu', 'Affiliation': 'Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Sanjeewa', 'Initials': 'S', 'LastName': 'Wickremasinghe', 'Affiliation': 'Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Salmaan', 'Initials': 'S', 'LastName': 'Al-Qureshi', 'Affiliation': 'Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Lyndell L', 'Initials': 'LL', 'LastName': 'Lim', 'Affiliation': 'Department of Surgery (Ophthalmology), Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, East Melbourne, Victoria, Australia limllp@unimelb.edu.au.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313437']
1479,31106491,Newborn physical condition and breastfeeding behaviours: Secondary outcomes of a cluster-randomized trial of prenatal lipid-based nutrient supplements in Bangladesh.,"Prenatal nutritional supplements may improve birth outcomes. This study aims to examine the effect of prenatal lipid-based nutrient supplements (LNS), compared with iron and folic acid (IFA), on general newborn physical condition and feeding behaviours. We conducted a cluster-randomized effectiveness trial that enrolled 4,011 pregnant women at ≤20 gestational weeks. LNS and IFA were provided to women in 48 and 16 clusters, respectively, for daily consumption until delivery. We collected data on household socio-economic, food insecurity, and maternal characteristics during early pregnancy and on newborn condition and feeding within 72 hr of delivery. We analysed intervention effects on these secondary outcomes using mixed models with analysis of covariance for continuous outcomes and logistic regression for dichotomous outcomes. Among 3,664 live births, intervention groups did not differ in newborn response, mother's rating of the general condition of her newborn, early initiation of breastfeeding (EIBF), suckling ability, or frequency and exclusivity of breastfeeding in the first 24 hr. If the mother perceived her infant to be healthy, EIBF was more likely (OR [95% CI]: 2.08 [1.46, 2.97]) and frequency of breastfeeding in the first 24 hr was greater (mean difference [95% CI]: 3.0 [1.91, 4.01]), but there was no difference in exclusive breastfeeding in the first 24 hr. Newborn condition and early breastfeeding practices were not affected by giving mothers prenatal LNS versus IFA. However, early breastfeeding practices were related to maternal perception of her newborn's condition. Thus, interventions to improve breastfeeding practices for newborns with poorer perceived health status may be useful.",2019,"Among 3,664 live births, intervention groups did not differ in newborn response, mother's rating of the general condition of her newborn, early initiation of breastfeeding (EIBF), suckling ability, or frequency and exclusivity of breastfeeding in the first 24 hr.","['Newborn physical condition and breastfeeding behaviours', 'enrolled 4,011 pregnant women at ≤20 gestational weeks', 'general newborn physical condition and feeding behaviours', 'Bangladesh']","['prenatal lipid-based nutrient supplements (LNS), compared with iron and folic acid (IFA', 'Prenatal nutritional supplements', 'prenatal lipid-based nutrient supplements']","['frequency of breastfeeding', 'household socio-economic, food insecurity, and maternal characteristics during early pregnancy and on newborn condition and feeding within 72\xa0hr of delivery', 'birth outcomes', 'Newborn condition and early breastfeeding practices', 'exclusive breastfeeding', ""maternal perception of her newborn's condition"", ""newborn response, mother's rating of the general condition of her newborn, early initiation of breastfeeding (EIBF), suckling ability, or frequency and exclusivity of breastfeeding""]","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C3494174', 'cui_str': 'Food Insecurity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2317036', 'cui_str': 'Initiation of breastfeeding'}, {'cui': 'C0566398', 'cui_str': 'Does suckle (finding)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",4011.0,0.0875295,"Among 3,664 live births, intervention groups did not differ in newborn response, mother's rating of the general condition of her newborn, early initiation of breastfeeding (EIBF), suckling ability, or frequency and exclusivity of breastfeeding in the first 24 hr.","[{'ForeName': 'Md Barkat', 'Initials': 'MB', 'LastName': 'Ullah', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Malay K', 'Initials': 'MK', 'LastName': 'Mridha', 'Affiliation': 'Center for Non-communicable Disease and Nutrition, James P. Grant School of Public Health, BRAC University, Dhaka, Bangladesh.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Susana L', 'Initials': 'SL', 'LastName': 'Matias', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Md Showkat A', 'Initials': 'MSA', 'LastName': 'Khan', 'Affiliation': 'Center for Non-communicable Disease and Nutrition, James P. Grant School of Public Health, BRAC University, Dhaka, Bangladesh.'}, {'ForeName': 'Zakia', 'Initials': 'Z', 'LastName': 'Siddiqui', 'Affiliation': 'Health System and Population Studies Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Mokbul', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'Center for Non-communicable Disease and Nutrition, James P. Grant School of Public Health, BRAC University, Dhaka, Bangladesh.'}, {'ForeName': 'Rina Rani', 'Initials': 'RR', 'LastName': 'Paul', 'Affiliation': 'Division of Health, CARE Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12844']
1480,30978434,Autograft immune content and survival in non-Hodgkin's lymphoma: A post hoc analysis.,"The infusion of autograft absolute lymphocyte and monocyte counts affect survival in patients undergoing autologous peripheral hematopoietic stem cell transplantation (APHSCT). However, the specific autograft immune effector cells affecting survival post-APHSCT are unknown. Thus, we performed an ad hoc analysis from our published double-blind, randomized phase III clinical trial in non-Hodgkin's lymphoma (NHL) patients, looking at the infused autograft immune effector cells and their relationship with clinical outcomes post-APHSCT. Between December 2007 and October 2010, we performed a double-blind phase III randomized study registered with ClinicalTrials.gov, number NCT00566228. A total of 111 patients finished the trial and apheresis collection samples were analyzed for immune effector cells. Overall survival (OS) and progression-free survival (PFS) were calculated from the date of APHSCT. With a median follow-up of 82.8 months (range: 2.1-122.3 months), we identified by univariate analysis that the autograft numbers of macrophage type 1 (M 1), macrophage type 2 (M 2), dendritic cell type 1 (DC 1), dendritic cell type 2 (DC 2), myeloid-derived suppressor cells (MDSC), CD4+PD-1-, CD4+PD-1+, CD8+PD-1-, CD8+PD-1+, lymphocyte to monocyte ratio (A-LMR), NKp30, and KIR2DL2, were predictors for OS and PFS. Multivariate analysis revealed that A-LMR, MDSC, NKp30, KIR2DL2 and lactate dehydrogenase were independent predictors for OS. Independent predictors for PFS identified by multivariate analysis included DC1, MDSC, NKp30, CD4+PD-1- and M 2. Our findings indicate that the number of specific infused autograft immune effector cells affect survival ; thus providing a platform to develop an immunocompetent autograft with direct impact on clinical outcomes in NHL post-APHSCT.",2019,"Multivariate analysis revealed that A-LMR, MDSC, NKp30, KIR2DL2 and lactate dehydrogenase were independent predictors for OS.","[""non-Hodgkin's lymphoma"", '111 patients finished the trial and apheresis collection samples', 'patients undergoing autologous peripheral hematopoietic stem cell transplantation (APHSCT', 'Between December 2007 and October 2010']",[],"['DC1, MDSC, NKp30, CD4+PD-1- and M 2', 'Autograft immune content and survival', 'Overall survival (OS) and progression-free survival (PFS', 'autograft numbers of macrophage type 1 (M 1), macrophage type 2 (M 2), dendritic cell type 1 (DC 1), dendritic cell type 2 (DC 2), myeloid-derived suppressor cells (MDSC), CD4+PD-1-, CD4+PD-1+, CD8+PD-1-, CD8+PD-1+, lymphocyte to monocyte ratio (A-LMR), NKp30, and KIR2DL2', 'A-LMR, MDSC, NKp30, KIR2DL2 and lactate dehydrogenase']","[{'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0005791', 'cui_str': 'Pheresis'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]",[],"[{'cui': 'C4277543', 'cui_str': 'Myeloid-Derived Suppressor Cells'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0539005', 'cui_str': 'M-1 (alpha)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011306', 'cui_str': 'Dendritic Cells'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}]",111.0,0.323007,"Multivariate analysis revealed that A-LMR, MDSC, NKp30, KIR2DL2 and lactate dehydrogenase were independent predictors for OS.","[{'ForeName': 'Luis F', 'Initials': 'LF', 'LastName': 'Porrata', 'Affiliation': 'Division of Hematology, Department of Medicine, Mayo Clinic, 200 First St. SW, Rochester, MN 55905, United States. Electronic address: porrata.luis@mayo.edu.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Inwards', 'Affiliation': 'Division of Hematology, Department of Medicine, Mayo Clinic, 200 First St. SW, Rochester, MN 55905, United States.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ansell', 'Affiliation': 'Division of Hematology, Department of Medicine, Mayo Clinic, 200 First St. SW, Rochester, MN 55905, United States.'}, {'ForeName': 'Ivana N', 'Initials': 'IN', 'LastName': 'Micallef', 'Affiliation': 'Division of Hematology, Department of Medicine, Mayo Clinic, 200 First St. SW, Rochester, MN 55905, United States.'}, {'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Johnston', 'Affiliation': 'Division of Hematology, Department of Medicine, Mayo Clinic, 200 First St. SW, Rochester, MN 55905, United States.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Villasboas', 'Affiliation': 'Division of Hematology, Department of Medicine, Mayo Clinic, 200 First St. SW, Rochester, MN 55905, United States.'}, {'ForeName': 'Svetomir N', 'Initials': 'SN', 'LastName': 'Markovic', 'Affiliation': 'Division of Hematology, Department of Medicine, Mayo Clinic, 200 First St. SW, Rochester, MN 55905, United States; Department of Medical Oncology, Mayo Clinic 200 First St. SW, Rochester, MN, 55905.'}]",Leukemia research,['10.1016/j.leukres.2019.03.009']
1481,31095458,Diurnal repeated exercise promotes slow-wave activity and fast-sigma power during sleep with increase in body temperature: a human crossover trial.,"The effects of exercise on sleep have been explored from various perspectives, but little is known about how the effects of acute exercise on sleep are produced through physiological functions. We used a protocol of multiple daytime sessions of moderate-intensity aerobic exercise and examined the subsequent effects on sleep structure, core body temperature (CBT), distal-proximal skin temperature gradient (DPG), and subjective parameters. Fourteen healthy men who did not exercise regularly were evaluated under the baseline (no exercise) and exercise conditions on a within-subject crossover basis. Under the exercise condition, each participant performed a 40-min aerobic workout at 40% of maximal oxygen intake, four times between morning and early evening. We observed a 33% increase in slow-wave sleep (SWS;  P  = 0.005), as well as increases in slow-wave activity (SWA;  P  = 0.026), the fast-sigma power/SWA ratio ( P  = 0.005), and subjective sleep depth and restorativeness the following morning. Moreover, both CBT and the DPG increased during sleep after exercise ( P  = 0.021 and  P  = 0.047, respectively). Regression analysis identified an increased nocturnal DPG during sleep after exercise as a factor in the increase in SWA. The fast-sigma/SWA ratio correlated with CBT. The performance of acute exercise promotes SWS with nocturnal elevation in the DPG. Both CBT and fast-sigma power may play a role in the specific physiological status of the body after exercise.  NEW & NOTEWORTHY  We used multiple daytime sessions of moderate-intensity aerobic exercise to examine the effects on the sleep structure, core body temperature (CBT), distal-proximal skin temperature gradient (DPG), and subjective parameters. Significant increases in slow-wave activity (SWA), CBT, DPG, fast-sigma power, and subjective parameters were observed during the night and the following morning. Nocturnal DPG is a factor in the increased SWA.",2019,"We observed a 33% increase in slow-wave sleep ( p =0.005), as well as increases in slow-wave activity ( p =0.026), the fast-sigma power/slow-wave activity ratio ( p =0.005), and subjective sleep depth and restorativeness the following morning.",['Fourteen healthy men who did not exercise regularly were evaluated under the baseline (no exercise) and exercise conditions on a within-subject crossover basis'],[],"['fast-sigma power/slow-wave activity ratio', 'distal-proximal skin temperature gradient', 'sleep structure, core body temperature, distal-proximal skin temperature gradient, and subjective parameters', 'slow-wave sleep', 'subjective sleep depth', 'fast-sigma/ slow-wave activity ratio', 'nocturnal distal-proximal skin temperature gradient', 'slow-wave activity']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0556454', 'cui_str': 'Exercises regularly (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1626935', 'cui_str': 'Base'}]",[],"[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1719918', 'cui_str': 'Sigma'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature (observable entity)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}]",14.0,0.0152573,"We observed a 33% increase in slow-wave sleep ( p =0.005), as well as increases in slow-wave activity ( p =0.026), the fast-sigma power/slow-wave activity ratio ( p =0.005), and subjective sleep depth and restorativeness the following morning.","[{'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Aritake-Okada', 'Affiliation': 'Faculty of Sport Sciences, Sport Psychiatry and Neuroscience Laboratory, Waseda University , Tokyo , Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University , Tokyo , Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Mochizuki', 'Affiliation': 'Sleep Research Institute, Edogawa University , Chiba , Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Ochiai', 'Affiliation': 'Health Care Food Research Laboratories, Kao Corporation , Tokyo , Japan.'}, {'ForeName': 'Masanobu', 'Initials': 'M', 'LastName': 'Hibi', 'Affiliation': 'Health Care Food Research Laboratories, Kao Corporation , Tokyo , Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Health Care Food Research Laboratories, Kao Corporation , Tokyo , Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Katsuragi', 'Affiliation': 'Health Care Food Research Laboratories, Kao Corporation , Tokyo , Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Ganeko', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University , Tokyo , Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Takeda', 'Affiliation': 'Division of Liberal Arts, Kogakuin University , Tokyo , Japan.'}, {'ForeName': 'Sunao', 'Initials': 'S', 'LastName': 'Uchida', 'Affiliation': 'Faculty of Sport Sciences, Sport Psychiatry and Neuroscience Laboratory, Waseda University , Tokyo , Japan.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00765.2018']
1482,31095461,Effect of acute dietary nitrate supplementation on sympathetic vasoconstriction at rest and during exercise.,"Dietary nitrate (  N O 3 -  ) supplementation has been shown to reduce resting blood pressure. However, the mechanism responsible for the reduction in blood pressure has not been identified. Dietary  N O 3 -  supplementation may increase nitric oxide (NO) bioavailability, and NO has been shown to inhibit sympathetic vasoconstriction in resting and contracting skeletal muscle. Therefore, the purpose of this study was to investigate the hypothesis that acute dietary  N O 3 -  supplementation would attenuate sympathetic vasoconstrictor responsiveness at rest and during exercise. In a double-blind randomized crossover design, 12 men (23 ± 5 yr) performed a cold-pressor test (CPT) at rest and during moderate- and heavy-intensity alternate-leg knee-extension exercise after consumption of  N O 3 -  rich beetroot juice (~12.9 mmol  N O 3 -  ) or a  N O 3 -  -depleted placebo (~0.13 mmol  N O 3 -  ). Venous blood was sampled before and 2.5 h after the consumption of beetroot juice for the measurement of total plasma nitrite/  N O 3 -  [NO x ]. Beat-by-beat blood pressure was measured by Finometer. Leg blood flow was measured at the femoral artery via Doppler ultrasound, and leg vascular conductance (LVC) was calculated. Sympathetic vasoconstrictor responsiveness was calculated as the percentage decrease in LVC in response to the CPT. Total plasma [NO x ] was greater ( P  < 0.001) in the  N O 3 -  (285 ± 120 µM) compared with the placebo (65 ± 30 µM) condition. However, mean arterial blood pressure and plasma catecholamines were not different ( P  > 0.05) between  N O 3 -  and placebo conditions at rest or during moderate- and heavy-intensity exercise. Sympathetic vasoconstrictor responsiveness (Δ% LVC) was not different ( P  > 0.05) between  N O 3 -  and placebo conditions at rest (  N O 3 -  : -33 ± 10%; placebo: -35 ± 11%) or during moderate (  N O 3 -  : -18 ± 8%; placebo: -20 ± 10%)- and heavy (  N O 3 -  : -12 ± 8%; placebo: -11 ± 9%)-intensity exercise. These data demonstrate that acute dietary  N O 3 -  supplementation does not alter sympathetic vasoconstrictor responsiveness at rest or during exercise in young healthy males.  NEW & NOTEWORTHY  Dietary nitrate may increase nitric oxide bioavailability, and nitric oxide has been shown to attenuate sympathetic vasoconstriction in resting and contracting skeletal muscle and enhance functional sympatholysis. However, the effect of dietary nitrate on sympathetic vasoconstrictor responsiveness is unknown. Acute dietary nitrate supplementation did not alter blood pressure or sympathetic vasoconstrictor responsiveness at rest or during exercise in young healthy males.",2019,Sympathetic vasoconstrictor responsiveness (Δ% LVC) was not different ( P  > 0.05) between  N O,"['12 men (23\u2009±\u20095 yr) performed a', 'young healthy males']","['Acute dietary nitrate supplementation', 'placebo', 'dietary nitrate', 'acute dietary nitrate supplementation', 'placebo: -20\u2009±\u200910%)- and heavy (  N O 3 -  : -12\u2009±\u20098%; placebo: -11\u2009±\u20099%)-intensity exercise', 'Dietary nitrate (  N O 3 -  ) supplementation', 'cold-pressor test (CPT) at rest and during moderate- and heavy-intensity alternate-leg knee-extension exercise after consumption of  N O 3 -  rich beetroot juice (~12.9 mmol  N O 3 -  ) or a  N O 3 -  -depleted placebo']","['blood pressure', 'Total plasma [NO', 'Sympathetic vasoconstrictor responsiveness', 'leg vascular conductance (LVC', 'Beat-by-beat blood pressure', 'Leg blood flow', 'resting blood pressure', 'Venous blood', 'nitric oxide (NO) bioavailability', 'sympathetic vasoconstrictor responsiveness', 'sympathetic vasoconstriction', 'mean arterial blood pressure and plasma catecholamines', 'blood pressure or sympathetic vasoconstrictor responsiveness']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0439190', 'cui_str': 'mmol'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0042397', 'cui_str': 'Vasoactive Agonists'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C1456863', 'cui_str': 'Vasoconstriction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0857652', 'cui_str': 'Plasma catecholamines'}]",,0.125454,Sympathetic vasoconstrictor responsiveness (Δ% LVC) was not different ( P  > 0.05) between  N O,"[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'de Vries', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta , Edmonton, Alberta , Canada.'}, {'ForeName': 'Darren S', 'Initials': 'DS', 'LastName': 'DeLorey', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta , Edmonton, Alberta , Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.01053.2018']
1483,30664702,Anemia is an independent risk factor for cardiovascular and renal events in hypertensive outpatients with well-controlled blood pressure: a subgroup analysis of the ATTEMPT-CVD randomized trial.,"To investigate whether anemia is an independent risk factor for cardiovascular and renal events in hypertensive outpatients, we performed a subgroup analysis of the ATTEMPT-CVD study based on baseline hemoglobin. The ATTEMPT-CVD study was a multicenter, prospective, randomized study of hypertensive outpatients that compared the efficacy of angiotensin receptor blocker (ARB)-based antihypertensive treatment with non-ARB antihypertensive treatment over 3 years. In the present subanalysis, ATTEMPT-CVD study participants (n = 1213) were categorized into the anemic group and nonanemic group according to their baseline hemoglobin. We compared the anemic and nonanemic groups mainly in regard to the incidence of cardiovascular and renal events and blood pressure. We also performed a multivariable Cox proportional hazards analysis to determine the prognostic factors that were independently associated with cardiovascular and renal events. Of the 1213 patients enrolled in the ATTEMPT-CVD, 194 patients had anemia (mostly mild anemia) and 1019 patients did not. Blood pressure was well-controlled during the 3 years of antihypertensive therapy in both the anemic and nonanemic groups. However, the incidence of cardiovascular and renal events was significantly greater in the anemic group than in the nonanemic group (HR = 1.945: 95%CI 1.208-3.130; P = 0.0062). Even after adjustment, anemia was independently associated with cardiovascular and renal events (HR = 1.816: 95%CI 1.116-2.955; P = 0.0163) in overall hypertensive patients with well-controlled blood pressure. Anemia, even mild anemia, is an independent risk factor for cardiovascular and renal events in hypertensive outpatients whose blood pressure is well-controlled. Thus, anemia may be a novel therapeutic target for cardiovascular and renal diseases in hypertensive outpatients with anemia.",2019,"Anemia, even mild anemia, is an independent risk factor for cardiovascular and renal events in hypertensive outpatients whose blood pressure is well-controlled.","['hypertensive outpatients with anemia', 'hypertensive outpatients with well-controlled blood pressure', 'hypertensive outpatients', '1213 patients enrolled in the ATTEMPT-CVD, 194 patients had anemia (mostly mild anemia) and 1019 patients did not', 'participants (n\u2009=\u20091213) were categorized into the anemic group and nonanemic group according to their baseline hemoglobin']",['angiotensin receptor blocker (ARB)-based antihypertensive treatment with non-ARB antihypertensive treatment'],"['Blood pressure', 'incidence of cardiovascular and renal events', 'incidence of cardiovascular and renal events and blood pressure', 'cardiovascular and renal events']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0450318', 'cui_str': '1019'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]","[{'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",1213.0,0.0258605,"Anemia, even mild anemia, is an independent risk factor for cardiovascular and renal events in hypertensive outpatients whose blood pressure is well-controlled.","[{'ForeName': 'Shokei', 'Initials': 'S', 'LastName': 'Kim-Mitsuyama', 'Affiliation': 'Department of Pharmacology and Molecular Therapeutics, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan. mitsuyam@gpo.kumamoto-u.ac.jp.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Soejima', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yasuda', 'Affiliation': 'Department of Sports and Life Sciences, National Institute of Fitness and Sports in Kanoya, Kanoya, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Diabetes Care Center, Jinnouchi Clinic, Kumamoto, Japan.'}, {'ForeName': 'Eiichiro', 'Initials': 'E', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Taiji', 'Initials': 'T', 'LastName': 'Sekigami', 'Affiliation': 'Division of Internal Medicine & Diabetes and Endocrine, Sekigami Clinic, Yatsushiro, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Matsui', 'Affiliation': 'Department of General and Community Medicine, Kumamoto University Hospital, Kumamoto, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0210-1']
1484,31099272,Economic evaluation of a supported employment program for veterans with spinal cord injury.,"Objective:  To estimate the net monetary benefit of an individual placement and support-based supported employment program for Veterans with spinal cord injuries. Design:  Economic evaluation comparing a supported employment program to treatment as usual, using cost and quality-of-life data from a longitudinal study of Veterans with spinal cord injuries. Setting:  Spinal cord injury centers in the Veterans Health Administration. Participants:  Subjects ( N  = 213) who participated in a 24-month supported employment program at seven spinal cord injury centers. Supported employment participants were compared with a group of spinal cord injury Veterans who received treatment as usual in a prior study. Main outcome measures:  Costs and quality-adjusted life years using the Veterans Rand-6 Dimension, estimated from the Veterans Rand 36-Item Health Survey. Results:  The supported employment program was more effective at both 1- and 2-year periods compared with treatment as usual. Outpatient costs were significantly higher for supported employment, but inpatient costs were not significantly different from treatment as usual. When cost and effectiveness were compared jointly using net monetary benefit, a supported employment program following the core principles of Individual Placement and Supported employment was more effective but not cost-effective at standard willingness to pay thresholds. When we considered a sub-group of the supported employment participants who more closely resemble the treatment as usual group from a randomized trial, there was no significant difference in the cost-effectiveness of supported employment when compared to treatment as usual. Conclusions:  With higher effectiveness and similar costs, supported employment for spinal cord injury Veterans has the potential to be cost-effective. Future studies need to randomize participants or carefully match participants based on observable patient characteristics to improve cost-effectiveness evaluations of this population.Implications for RehabilitationSupported employment as part of ongoing rehabilitation care helps individuals with spinal cord injury return to work and improve their quality of life.Many studies show that supported employment programs are cost effective for persons with mental disabilities, but there is only limited economic evaluation data on use of supported employment with persons with spinal cord injury.This study shows that supported employment integrated with ongoing rehabilitation care is more effective in restoring employment and health-related quality of life.",2020,"Outpatient costs were significantly higher for supported employment, but inpatient costs were not significantly different from treatment as usual.","['Veterans with spinal cord injuries', 'Subjects (N\u2009=\u2009213) who participated in a 24-month supported employment program at seven spinal cord injury centers', 'Spinal cord injury centers in the Veterans Health Administration', 'spinal cord injury Veterans', 'veterans with spinal cord injury', 'persons with mental disabilities']","['individual placement and support-based supported employment program', 'supported employment program']","['Costs and quality-adjusted life years using the Veterans Rand-6 Dimension, estimated from the Veterans Rand 36-Item Health Survey', 'inpatient costs', 'cost-effectiveness of supported employment', 'Outpatient costs']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0085362', 'cui_str': 'Employment, Supported'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1306341', 'cui_str': 'Mental handicap (finding)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085362', 'cui_str': 'Employment, Supported'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]",,0.054043,"Outpatient costs were significantly higher for supported employment, but inpatient costs were not significantly different from treatment as usual.","[{'ForeName': 'Bryce S', 'Initials': 'BS', 'LastName': 'Sutton', 'Affiliation': 'Center of Innovation on Disability and Rehabilitation Research, James A. Haley Veterans Hospital, Tampa, FL, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ottomanelli', 'Affiliation': 'Center of Innovation on Disability and Rehabilitation Research, James A. Haley Veterans Hospital, Tampa, FL, USA.'}, {'ForeName': 'Eni', 'Initials': 'E', 'LastName': 'Njoh', 'Affiliation': 'Center of Innovation on Disability and Rehabilitation Research, James A. Haley Veterans Hospital, Tampa, FL, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barnett', 'Affiliation': 'Center of Innovation on Disability and Rehabilitation Research, James A. Haley Veterans Hospital, Tampa, FL, USA.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Goetz', 'Affiliation': 'Hunter Holmes McGuire VA Medical Center, Richmond, VI, USA.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1527955']
1485,31098989,Efficacy and Safety of Meropenem-Vaborbactam Versus Best Available Therapy for the Treatment of Carbapenem-Resistant Enterobacteriaceae Infections in Patients Without Prior Antimicrobial Failure: A Post Hoc Analysis.,"INTRODUCTION


Infections due to Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriaceae are associated with increased morbidity and high mortality. Meropenem-vaborbactam (MV) is a novel β-lactam/β-lactamase inhibitor combination active against KPC-producing Enterobacteriaceae. The aim of this post hoc analysis of the TANGO-II randomized controlled trial was to assess the efficacy of MV versus best available therapy (BAT) in the subgroup of patients without prior antimicrobial failure.
METHODS


The primary outcome measure was clinical cure at the test of cure (TOC). Secondary outcome measures included (1) clinical cure at the end of therapy (EOT), (2) microbiological cure at TOC, (3) microbiological cure at EOT, and (4) 28-day all-cause mortality.
RESULTS


First-line MV was associated with a 42.9% absolute increase in clinical cure rate at TOC (95% confidence intervals [CI] 13.7-72.1) in comparison with first-line BAT. A 49.3% absolute increase in clinical cure rate at EOT (95% CI 20.8-77.7), a 42.6% absolute increase in microbiological cure rate at EOT (95% CI 13.4-71.8), and a 36.2% absolute increase in microbiologic cure rate at TOC (95% CI 5.9-66.6) were also observed, in addition to a 29.0% absolute reduction in mortality (95% CI - 54.3 to - 3.7). Overall, fewer adverse events were observed in the MV group than in the BAT group.
CONCLUSION


MV was superior to BAT in the subgroup of patients with serious carbapenem-resistant Enterobacteriaceae (CRE) infections and no prior antimicrobial failure, with very high rates of clinical success, and was well tolerated. Post approval and real-world studies remain essential to clearly define the most appropriate population for early, empirical MV coverage, in accordance with antimicrobial stewardship principles.
FUNDING


The Medicines Company.",2019,"A 49.3% absolute increase in clinical cure rate at EOT (95% CI 20.8-77.7), a 42.6% absolute increase in microbiological cure rate at EOT (95% CI 13.4-71.8), and a 36.2% absolute increase in microbiologic cure rate at TOC (95% CI 5.9-66.6) were also observed, in addition to a 29.0% absolute reduction in mortality (95% CI - 54.3 to - 3.7).","['Patients', 'subgroup of patients without prior antimicrobial failure', 'Without Prior Antimicrobial Failure']","['MV versus best available therapy (BAT', 'Meropenem-vaborbactam (MV', 'Meropenem-Vaborbactam']","['clinical cure rate at TOC', 'adverse events', 'microbiologic cure rate at TOC', 'microbiological cure rate', 'clinical cure rate', 'Efficacy and Safety', 'mortality', 'clinical cure at the test of cure (TOC', '1) clinical cure at the end of therapy (EOT), (2) microbiological cure at TOC, (3) microbiological cure at EOT, and (4) 28-day all-cause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008139', 'cui_str': 'Bats'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C4519317', 'cui_str': 'Vaborbactam'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",,0.203953,"A 49.3% absolute increase in clinical cure rate at EOT (95% CI 20.8-77.7), a 42.6% absolute increase in microbiological cure rate at EOT (95% CI 13.4-71.8), and a 36.2% absolute increase in microbiologic cure rate at TOC (95% CI 5.9-66.6) were also observed, in addition to a 29.0% absolute reduction in mortality (95% CI - 54.3 to - 3.7).","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bassetti', 'Affiliation': 'Infectious Diseases Division, Department of Medicine, University of Udine and Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy. matteo.bassetti@asuiud.sanita.fvg.it.'}, {'ForeName': 'Daniele Roberto', 'Initials': 'DR', 'LastName': 'Giacobbe', 'Affiliation': 'Department of Health Sciences, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Melinta Therapeutics, Inc., New Haven, CT, USA.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Tillotson', 'Affiliation': 'GST Micro LLC, Henrico, VA, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Massey', 'Affiliation': 'Melinta Therapeutics, Inc., New Haven, CT, USA.'}]",Advances in therapy,['10.1007/s12325-019-00981-y']
1486,31743569,"Long-term (52-week) efficacy and safety of ipragliflozin add-on therapy to insulin in Japanese patients with type 1 diabetes mellitus: An uncontrolled, open-label extension of a phase III study.","INTRODUCTION


The aim of the present study was to assess the long-term (52-week) efficacy and safety of ipragliflozin in insulin-treated Japanese patients with type 1 diabetes mellitus and inadequate glycemic control.
MATERIALS AND METHODS


In this 28-week, open-label extension of a multicenter, randomized, placebo-controlled, 24-week phase III study, ipragliflozin recipients continued treatment (50 mg, once daily), and placebo recipients were switched to once-daily 50 mg ipragliflozin at the start of the extension period. The ipragliflozin dose could be increased to 100 mg if warranted. The primary end-point was change in glycated hemoglobin; secondary end-points were change in insulin dose and bodyweight. Safety outcomes were monitored as treatment-emergent adverse events.
RESULTS


A total of 53 (placebo switched to ipragliflozin) and 108 (ipragliflozin) patients completed the open-label extension (treatment period 2), with 24 and 44 patients, respectively, receiving dose increases. From baseline to end of treatment, the overall mean change (standard deviation [SD]) in glycated hemoglobin was -0.33% (0.72; -3.7 mmol/mol [7.9]), with changes in basal, bolus and total insulin doses of -3.76 IU (SD 3.85 IU), -2.51 IU (SD 7.08 IU) and -6.27 IU (SD 8.16 IU), respectively. No serious drug-related treatment-emergent adverse events or deaths were reported. Treatment-emergent adverse events leading to study discontinuation occurred in zero and three (2.6%) patients in the placebo switched to ipragliflozin and ipragliflozin groups, respectively; all were considered drug-related. There were no cases of severe hypoglycemia or diabetic ketoacidosis, and no safety concerns related to dose increase.
CONCLUSIONS


The efficacy and safety of 50 mg, once-daily ipragliflozin in insulin-treated type 1 diabetes mellitus patients were confirmed in this long-term, open-label extension study. No safety concerns were attributed to a dose increase to 100 mg.",2020,No serious drug-related TEAEs or deaths were reported.,"['insulin-treated Japanese patients with type 1 diabetes mellitus (T1DM) and inadequate glycemic control', 'Japanese patients with type 1 diabetes mellitus', 'Fifty-three (placeboipragliflozin) and 108 (ipragliflozin) patients']","['placebo', 'placeboipragliflozin and ipragliflozin', 'ipragliflozin']","['treatment-emergent adverse events (TEAEs', 'glycated hemoglobin (HbA1c); secondary endpoints were change in insulin dose and body weight', 'severe hypoglycemia or diabetic ketoacidosis']","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3492889', 'cui_str': 'ipragliflozin'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2959938', 'cui_str': 'Change in insulin dose (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}]",,0.076278,No serious drug-related TEAEs or deaths were reported.,"[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Department of Medicine, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Isaka', 'Affiliation': 'Japan/Asia Clinical Development, Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Taishi', 'Initials': 'T', 'LastName': 'Sakatani', 'Affiliation': 'Data Science, Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Toyoshima', 'Affiliation': 'Clinical Pharmacology and Exploratory Development, Astellas Pharma Inc., Tokyo, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13181']
1487,31097515,Differential blood pressure response to continuous positive airway pressure treatment according to the circadian pattern in hypertensive patients with obstructive sleep apnoea.,"Continuous positive airway pressure (CPAP) has a heterogeneous effect on blood pressure (BP) in hypertensive patients. However, the effect of CPAP on BP in hypertensive subjects regarding circadian BP pattern has never been explored. This study aimed to assess the effect of CPAP on BP, taking into consideration the circadian BP pattern in untreated hypertensive patients.This study is a  post hoc  analysis of the Spanish Cohort for the Study of the Effect of CPAP in Hypertension (CEPECTA), a multicentre, randomised trial of CPAP  versus  sham-CPAP in patients with new-onset systemic hypertension and an apnoea-hypopnoea index >15 events·h -1  We included patients for whom 24-h ambulatory BP monitoring (ABPM) data were available at baseline and 12 weeks after the intervention. Subjects were classified based on the dipping ratio (dipper/non-dipper). We evaluated the effect of CPAP on ABPM parameters after 12 weeks of treatment.Overall, 272 hypertensive subjects were included in the analysis (113 dippers and 159 non-dippers). Baseline clinical and polysomnographic variables were similar between the groups. CPAP treatment in non-dipper patients was associated with reductions in 24-h ambulatory BP variables and night-time ambulatory BP measurements. However, a nonsignificant effect was reported in the dipper group. The differential effects of CPAP between the groups were -2.99 mmHg (95% CI -5.92-- -0.06 mmHg) for the mean 24-h ambulatory BP and -5.35 mmHg (95% CI -9.01- -1.69 mmHg) for the mean night-time ambulatory BP.Our results show a differential effect of CPAP treatment on BP in hypertensive patients depending on the circadian pattern. Only non-dipper patients benefited from CPAP treatment in terms of BP reduction.",2019,CPAP treatment in nondipper patients was associated with reductions in 24-h ambulatory BP variables and nighttime ambulatory BP measurements.,"['hypertensive patients with obstructive sleep apnea', 'untreated hypertensive patients', 'hypertensive patients depending on the circadian pattern', 'hypertensive patients', 'hypertensive subjects', '272 hypertensive subjects were included in the analysis (113 dippers/159 nondippers', 'patients with new-onset systemic hypertension and an apnea/hypopnea index']","['sham-CPAP', 'CPAP treatment', 'CPAP', 'Introduction:  Continuous positive airway pressure (CPAP']","['24-h ambulatory BP monitoring (ABPM) data', 'Differential blood pressure response', 'BP reduction', '24-h ambulatory BP variables and nighttime ambulatory BP measurements', 'blood pressure (BP', 'ABPM parameters']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",272.0,0.023483,CPAP treatment in nondipper patients was associated with reductions in 24-h ambulatory BP variables and nighttime ambulatory BP measurements.,"[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Sapiña-Beltrán', 'Affiliation': 'Hospital Universitari Arnau de Vilanova and Santa Maria, Group of Translational Research in Respiratory Medicine, IRB Lleida, Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Torres', 'Affiliation': 'Hospital Universitari Arnau de Vilanova and Santa Maria, Group of Translational Research in Respiratory Medicine, IRB Lleida, Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Benítez', 'Affiliation': 'Hospital Universitari Arnau de Vilanova and Santa Maria, Group of Translational Research in Respiratory Medicine, IRB Lleida, Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Santamaría-Martos', 'Affiliation': 'Hospital Universitari Arnau de Vilanova and Santa Maria, Group of Translational Research in Respiratory Medicine, IRB Lleida, Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Durán-Cantolla', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Egea', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Sánchez-de-la-Torre', 'Affiliation': 'Hospital Universitari Arnau de Vilanova and Santa Maria, Group of Translational Research in Respiratory Medicine, IRB Lleida, Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Barbé', 'Affiliation': 'Hospital Universitari Arnau de Vilanova and Santa Maria, Group of Translational Research in Respiratory Medicine, IRB Lleida, Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Dalmases', 'Affiliation': 'Hospital Universitari Arnau de Vilanova and Santa Maria, Group of Translational Research in Respiratory Medicine, IRB Lleida, Universitat de Lleida, Lleida, Spain mdalmases.lleida.ics@gencat.cat.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.00098-2019']
1488,31107710,PEELING OF THE INTERNAL LIMITING MEMBRANE WITH FOVEAL SPARING FOR TREATMENT OF DEGENERATIVE LAMELLAR MACULAR HOLE.,"PURPOSE


To compare the functional and anatomical results of fovea-sparing internal limiting membrane peeling during vitrectomy with those of observation for degenerative lamellar macular hole with lamellar hole-associated epiretinal proliferation.
DESIGN


A prospective, randomized, comparative pilot study.
METHODS


Thirty-six eyes were randomized to undergo surgery with foveal internal limiting membrane sparing (Group S) or observation only (Group C). The main outcome measures were foveal retinal sensitivity, visual acuity, and central retinal thickness.
RESULTS


After 6 months, a significant difference was found in foveal retinal sensitivity between Group S (12.8 ± 1.7 dB) and Group C (9.39 ± 1.8 dB; P < 0.001). Similarly, best-corrected visual acuity improved in Group S and remained stable in Group C (respectively, 0.17 ± 0.13 and 0.46 ± 0.21 logMAR; P < 0.001). A significant increase in central retinal thickness was observed in Group S, but not in Group C (272 ± 24 vs. 147 ± 20 µm, P < 0.001).
CONCLUSION


Fovea-sparing internal limiting membrane peeling is a feasible treatment for degenerative lamellar macular hole with lamellar hole-associated epiretinal proliferation, yielding better improvements in best-corrected visual acuity and foveal retinal sensitivity than observation alone. Further studies are needed to optimize this new surgical approach.",2020,"Similarly, best-corrected visual acuity improved in Group S and remained stable in Group C (respectively, 0.17 ± 0.13 and 0.46 ± 0.21 logMAR; P < 0.001).",['Thirty-six eyes'],"['surgery with foveal internal limiting membrane sparing (Group S) or observation only (Group C', 'Fovea-sparing internal limiting membrane peeling', 'fovea-sparing internal limiting membrane peeling during vitrectomy']","['foveal retinal sensitivity', 'central retinal thickness', 'foveal retinal sensitivity, visual acuity, and central retinal thickness', 'best-corrected visual acuity']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}]","[{'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",36.0,0.0446705,"Similarly, best-corrected visual acuity improved in Group S and remained stable in Group C (respectively, 0.17 ± 0.13 and 0.46 ± 0.21 logMAR; P < 0.001).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Morescalchi', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Russo', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gambicorti', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cancarini', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Nicolò', 'Initials': 'N', 'LastName': 'Scaroni', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Bahja', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Costagliola', 'Affiliation': 'Department of Health Sciences, Eye Clinic, University of Molise, Campobasso, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Semeraro', 'Affiliation': 'Department of Neurological and Vision Sciences, Eye Clinic, University of Brescia, Brescia, Italy.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002559']
1489,31100756,"Importance of Temperament in Individualized Homeopathic Prescription: Evaluation by an Open, Randomized, Pilot Trial.","BACKGROUND


The importance of temperament in the selection of an individualized homeopathic medicine has not been evaluated systematically. The current study explored this under-researched area.
MATERIALS AND METHODS


A prospective, open, randomized (1:1), two parallel arms, pilot trial was performed on patients suffering from various chronic diseases. Each patient's temperament was assessed using a newly developed ""temperament diagnostic questionnaire"". Outcome measures were health status using the EQ-5D-5L questionnaire and a visual analog scale (VAS) of patient's self-rated health, measured at baseline and at 3 months. Homeopathic medicines were prescribed on the basis of individualization, randomly with or without accounting for individual temperament, and patients grouped accordingly (temperament(+) and temperament(-)). Baseline comparability of the two groups was checked, followed by analysis of group differences. A  p- value < 0.01 was considered as statistically significant.
RESULTS


Fifty protocol-compliant patients were analyzed. The two groups were comparable at baseline. Over 3 months of intervention, there was significant improvement ( p  < 0.01) in each group. Though improvement in the EQ-5D-5L score was greater in the temperament(+) group (mean difference, 2.4; 95% confidence interval [CI], 0.2 to 4.5), the change did not achieve the threshold for statistical significance ( p  = 0.029). Improvement in VAS score was significantly greater in the temperament(+) group than in temperament(-) patients (mean difference, 15.2; 95% CI, 4.9 to 25.4;  p  = 0.004).
CONCLUSION


Considering temperament as a key element of individualized prescription may enhance health improvement from homeopathic treatment in chronic diseases. Independently replicated rigorous trials with validated scales are warranted.
TRIAL REGISTRATION


CTRI/2018/03/012433.",2019,"Improvement in VAS score was significantly greater in the temperament(+) group than in temperament(-) patients (mean difference, 15.2; 95% CI, 4.9 to 25.4;  p  = 0.004).
",['patients suffering from various chronic diseases'],['Homeopathic medicines'],"['VAS score', 'EQ-5D-5L score', 'temperament diagnostic questionnaire', ""health status using the EQ-5D-5L questionnaire and a visual analog scale (VAS) of patient's self-rated health""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}]","[{'cui': 'C0920324', 'cui_str': 'Homeopathic Remedies'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.140102,"Improvement in VAS score was significantly greater in the temperament(+) group than in temperament(-) patients (mean difference, 15.2; 95% CI, 4.9 to 25.4;  p  = 0.004).
","[{'ForeName': 'Najne', 'Initials': 'N', 'LastName': 'Sultana', 'Affiliation': 'Department of Repertory, National Institute of Homoeopathy, Kolkata, West Bengal, India.'}, {'ForeName': 'Amitava', 'Initials': 'A', 'LastName': 'Samanta', 'Affiliation': 'Department of Repertory, National Institute of Homoeopathy, Kolkata, West Bengal, India.'}, {'ForeName': 'Munmun', 'Initials': 'M', 'LastName': 'Koley', 'Affiliation': 'Independent Researcher, Hooghly, West Bengal, India.'}, {'ForeName': 'Subhranil', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Independent Researcher, Howrah, West Bengal, India.'}]",Homeopathy : the journal of the Faculty of Homeopathy,['10.1055/s-0039-1685142']
1490,31101487,The effect of EDTA-based chelation on patients with diabetes and peripheral artery disease in the Trial to Assess Chelation Therapy (TACT).,"OBJECTIVE


Approximately 1 in 7 US adults have diabetes; and over 60% of deaths in patients with diabetes have cardiac disease as a principal or contributing cause. Both coronary and peripheral artery disease (PAD) identify high-risk cohorts among patients with diabetes. We have previously demonstrated improved cardiovascular outcomes with edetate disodium-based chelation in post-MI patients with diabetes, enrolled in the Trial to Assess Chelation Therapy (TACT). In these analyses we further studied the effect size of patients with diabetes and severe disease in 2 vascular beds; coronaries, and lower extremity arteries. We questioned whether greater atherosclerotic burden would attenuate the observed beneficial effect of edetate disodium infusions.
RESEARCH DESIGN AND METHODS


The multicenter TACT used a double blind, placebo controlled, 2 × 2 factorial design with 1708 participants, randomly assigned to receive edetate disodium-based chelation, or placebo and high dose oral vitamins or placebo. There were 162 (9.5% of 1708) post-MI patients with a diagnosis of diabetes mellitus and PAD for this post hoc analysis. Patients received up to 40 double-blind intravenous infusions of edetate disodium-based chelation, or placebo. The composite primary endpoint of TACT consisted of death from any cause, myocardial infarction, stroke, coronary revascularization and hospitalization for angina.
RESULTS


The median age was 66 years, 15% female, 5% non-Caucasian, and BMI was 31. Insulin was used by 32% of patients. Active infusions significantly reduced the primary endpoint compared with placebo infusions (HR, 0.52; 95% CI, 0.30-0.92; P = 0.0069), with a 30% absolute risk reduction in the primary endpoint. There was a marked reduction in total mortality from 24% to 11%, although of borderline significance (P = 0.052).
CONCLUSION


Atherosclerotic disease in multiple vascular beds did not attenuate the beneficial effect of edetate disodium infusions in post MI patients with diabetes. Studies now in progress will prospectively test this post hoc finding.",2019,"Active infusions significantly reduced the primary endpoint compared with placebo infusions (HR, 0.52; 95% CI, 0.30-0.92; P = 0.0069), with a 30% absolute risk reduction in the primary endpoint.","['patients with diabetes', '1708 participants', 'patients with diabetes and peripheral artery disease in the Trial to Assess Chelation Therapy (TACT', 'post MI patients with diabetes', 'The median age was 66\u202fyears, 15% female, 5% non-Caucasian, and BMI was 31', 'patients with diabetes and severe disease in 2 vascular beds; coronaries, and lower extremity arteries', 'post-MI patients with diabetes']","['placebo', 'EDTA-based chelation', 'Chelation Therapy (TACT', 'edetate disodium-based chelation, or placebo and high dose oral vitamins or placebo', 'edetate disodium-based chelation, or placebo', 'disodium-based chelation', 'TACT']","['total mortality', 'cardiovascular outcomes', 'death from any cause, myocardial infarction, stroke, coronary revascularization and hospitalization for angina']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0007975', 'cui_str': 'Chelation Therapy'}, {'cui': 'C0618927', 'cui_str': 'TACT'}, {'cui': 'C0856742', 'cui_str': 'Post MI'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0529584', 'cui_str': 'isothiocyanatobenzyl-EDTA'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0007975', 'cui_str': 'Chelation Therapy'}, {'cui': 'C0618927', 'cui_str': 'TACT'}, {'cui': 'C0012695', 'cui_str': 'edetate sodium'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}]",1708.0,0.508501,"Active infusions significantly reduced the primary endpoint compared with placebo infusions (HR, 0.52; 95% CI, 0.30-0.92; P = 0.0069), with a 30% absolute risk reduction in the primary endpoint.","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ujueta', 'Affiliation': 'Department of Medicine, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA.'}, {'ForeName': 'Ivan A', 'Initials': 'IA', 'LastName': 'Arenas', 'Affiliation': 'Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Escolar', 'Affiliation': 'Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA.'}, {'ForeName': 'Denisse', 'Initials': 'D', 'LastName': 'Diaz', 'Affiliation': 'Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Boineau', 'Affiliation': 'National Center of Complementary and Integrative Health (NCCIH), Bethesda, MD, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Golden', 'Affiliation': 'The Golden Center for Integrative Medicine, Fresno, CA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Lindblad', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Hwasoon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Gervasio A', 'Initials': 'GA', 'LastName': 'Lamas', 'Affiliation': 'Department of Medicine, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA; Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA. Electronic address: gervasio.lamas@msmc.com.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.04.005']
1491,31091527,"Topiramate plus Cooling for Hypoxic-Ischemic Encephalopathy: A Randomized, Controlled, Multicenter, Double-Blinded Trial.","BACKGROUND AND OBJECTIVES


Therapeutic interventions to improve the efficacy of whole-body cooling for hypoxic-ischemic encephalopathy (HIE) are desirable. Topiramate has been effective in reducing brain damage in experimental studies. However, in the clinical setting information is limited to a small number of feasibility trials. We launched a randomized controlled double-blinded topiramate/placebo multicenter trial with the primary objective being to reduce the antiepileptic activity in cooled neonates with HIE and assess if brain damage would be reduced as a consequence.
STUDY DESIGN


Neonates were randomly assigned to topiramate or placebo at the initiation of hypothermia. Topiramate was administered via a nasogastric tube. Brain electric activity was continuously monitored. Topiramate pharmacokinetics, energy-related and Krebs' cycle intermediates, and lipid peroxidation biomarkers were determined using liquid chromatography-mass spectrometry and MRI for assessing brain damage.
RESULTS


Out of 180 eligible patients 110 were randomized, 57 (51.8%) to topiramate and 53 (48.2%) to placebo. No differences in the perinatal or postnatal variables were found. The topiramate group exhibited less seizure burden in the first 24 h of hypothermia (topiramate, n = 14 [25.9%] vs. placebo, n = 22 [42%]); needed less additional medication, and had lower mortality (topiramate, n = 5 [9.2%] vs. placebo, n = 10 [19.2%]); however, these results did not achieve statistical significance. Topiramate achieved a therapeutic range in 37.5 and 75.5% of the patients at 24 and 48 h, respectively. A significant association between serum topiramate levels and seizure activity (p < 0.016) was established. No differences for oxidative stress, energy-related metabolites, or MRI were found.
CONCLUSIONS


Topiramate reduced seizures in patients achieving therapeutic levels in the first hours after treatment initiation; however, they represented only a part of the study population. Our results warrant further studies with higher loading and maintenance dosing of topiramate.",2019,A significant association between serum topiramate levels and seizure activity (p < 0.016) was established.,"['180 eligible patients 110', 'Neonates', 'cooled neonates with HIE', 'Hypoxic-Ischemic Encephalopathy']","['topiramate', 'placebo', 'topiramate or placebo', 'Topiramate', 'topiramate/placebo', 'Topiramate plus Cooling']","['seizure burden', 'oxidative stress, energy-related metabolites, or MRI', 'Brain electric activity', 'lower mortality', 'antiepileptic activity', ""Topiramate pharmacokinetics, energy-related and Krebs' cycle intermediates, and lipid peroxidation biomarkers"", 'perinatal or postnatal variables', 'therapeutic range', 'serum topiramate levels and seizure activity']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic-Ischemic Encephalopathy'}]","[{'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1271826', 'cui_str': 'Serum topiramate level'}]",180.0,0.53915,A significant association between serum topiramate levels and seizure activity (p < 0.016) was established.,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nuñez-Ramiro', 'Affiliation': 'Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Benavente-Fernández', 'Affiliation': 'Division of Neonatology, University Hospital Puerta del Mar, Cádiz, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Valverde', 'Affiliation': 'Division of Neonatology, University Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Malaika', 'Initials': 'M', 'LastName': 'Cordeiro', 'Affiliation': 'Division of Neonatology, University Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Dorotea', 'Initials': 'D', 'LastName': 'Blanco', 'Affiliation': 'Division of Neonatology, University Hospital Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Boix', 'Affiliation': ""Department of Neonatology, University Hospital Vall d'Hebrón, Barcelona, Spain.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Cabañas', 'Affiliation': 'Division of Neonatology, University Hospital Quirónsalud Madrid, Madrid, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Chaffanel', 'Affiliation': 'Division of Neonatology, Regional University Hospital Málaga, Málaga, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Fernández-Colomer', 'Affiliation': 'Division of Neonatology, Central University Hospital of Asturias, Oviedo, Spain.'}, {'ForeName': 'Jose Ramón', 'Initials': 'JR', 'LastName': 'Fernández-Lorenzo', 'Affiliation': 'Division of Neonatology, University Hospital Complex of Vigo, Vigo, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kuligowski', 'Affiliation': 'Health Research Institute La Fe, Valencia, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Loureiro', 'Affiliation': 'Division of Neonatology, University Hospital Cruces, Bilbao, Spain.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Moral-Pumarega', 'Affiliation': 'Division of Neonatology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pavón', 'Affiliation': 'Division of Neonatology, University Hospital Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Sánchez-Illana', 'Affiliation': 'Health Research Institute La Fe, Valencia, Spain.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Tofé', 'Affiliation': 'Division of Neonatology, University Hospital Reina Sofía, Córdoba, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hervás', 'Affiliation': 'Department of Biostatistics, Health Research Institute La Fe, Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'García-Robles', 'Affiliation': 'Division of Neonatology, University Hospital Complex of Vigo, Vigo, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Parra-Llorca', 'Affiliation': 'Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cernada', 'Affiliation': 'Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Martinez-Rodilla', 'Affiliation': 'Health Research Institute La Fe, Valencia, Spain.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Lorente-Pozo', 'Affiliation': 'Health Research Institute La Fe, Valencia, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Llorens', 'Affiliation': 'Department of Radiology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Remedios', 'Initials': 'R', 'LastName': 'Marqués', 'Affiliation': 'Departament of Pharmacy, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Máximo', 'Initials': 'M', 'LastName': 'Vento', 'Affiliation': 'Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain, maximo.vento@uv.es.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neonatology,['10.1159/000499084']
1492,31739848,Technology Assisted Behavior Intervention to Extend Sleep Among Adults With Short Sleep Duration and Prehypertension/Stage 1 Hypertension: A Randomized Pilot Feasibility Study.,"STUDY OBJECTIVES


Short sleep duration contributes to hypertension, yet few behavioral sleep extension interventions have been developed. The goal of our study was to evaluate the feasibility and preliminary efficacy of a technology assisted sleep extension intervention among individuals with prehypertension/stage 1 hypertension on sleep, blood pressure and patient reported outcomes.
METHODS


Adults aged 30-65 with 24h ambulatory blood pressure (ABP) > 120/80 mmHg and average weekday sleep duration < 7 h/night were randomized 2:1 to a 6-week technology assisted intervention versus a self-management control group. The intervention included a wearable sleep tracker, smartphone application, weekly didactic lessons and brief telephone coaching. The control group was instructed to maintain their current sleep schedule. Data were analyzed using descriptive statistics and nonparametric statistics to evaluate differences in between groups as well as prepost changes within each group. We also conducted bivariate correlations to evaluate predictors of change in sleep and ABP.
RESULTS


A total of 16 adults were randomized into the study (11 intervention, 5 control group, 8 women, mean age 45.8 years, standard deviation 9.8 years.) Results at 6-week follow-up demonstrated greater improvement in the intervention group for total sleep time (P = .027), reductions in 24-hour systolic blood pressure (P = .013) and diastolic blood pressure (P = .026), improvements in sleep disturbance (P = .003) and sleep-related impairment (P = .008). Participants in the intervention group completed 90% of the coaching sessions and rated the enjoyment of the intervention as 4 or 5 out of 5.
CONCLUSIONS


Technology assisted sleep extension intervention is feasible and well liked in this population. Results demonstrate the potential for this intervention to improve sleep duration, quality and 24-hour ABP.",2019,"Results at 6-week follow-up demonstrated greater improvement in the intervention group for total sleep time (P = .027), reductions in 24-hour systolic blood pressure (P = .013) and diastolic blood pressure (P = .026), improvements in sleep disturbance (P = .003) and sleep-related impairment (P = .008).","['Adults aged 30-65 with 24h ambulatory blood pressure (ABP) > 120/80 mmHg and average weekday sleep duration < 7 h/night', 'Adults With Short Sleep Duration and Prehypertension/Stage 1 Hypertension', 'A total of 16 adults were randomized into the study (11 intervention, 5 control group, 8 women, mean age 45.8 years, standard deviation 9.8 years', 'individuals with prehypertension/stage 1 hypertension on sleep, blood pressure and patient reported outcomes']","['Technology assisted sleep extension intervention', 'wearable sleep tracker, smartphone application, weekly didactic lessons and brief telephone coaching', 'technology assisted intervention versus a self-management control group', 'Technology Assisted Behavior Intervention', 'technology assisted sleep extension intervention']","['sleep duration, quality and 24-hour ABP', 'total sleep time', 'Sleep', 'sleep disturbance', 'diastolic blood pressure', '24-hour systolic blood pressure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1696708', 'cui_str': 'Pre-Hypertension'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1282174', 'cui_str': '24 hour systolic blood pressure'}]",16.0,0.0540268,"Results at 6-week follow-up demonstrated greater improvement in the intervention group for total sleep time (P = .027), reductions in 24-hour systolic blood pressure (P = .013) and diastolic blood pressure (P = .026), improvements in sleep disturbance (P = .003) and sleep-related impairment (P = .008).","[{'ForeName': 'Kelly Glazer', 'Initials': 'KG', 'LastName': 'Baron', 'Affiliation': 'Department of Behavioral Sciences, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Duffecy', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'DeJuran', 'Initials': 'D', 'LastName': 'Richardson', 'Affiliation': 'Department of Mathematics and Computer Science, Lake Forest University, Lake Forest, Illinois.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Avery', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Rothschild', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lane', 'Affiliation': 'Department of Internal Medicine, Rush University Medical Center, Chicago, Illinois.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8018']
1493,31739859,Sleep/Wake Detection by Behavioral Response to Haptic Stimuli.,"STUDY OBJECTIVES


Actigraphy, the tool of choice for assessment of sleep phase disorders, is insensitive to movement-free waking. This study aimed to determine whether the detection of waking could be performed by recording instrumental responses to haptic stimuli delivered by a low-cost device.
METHODS


Twenty adults underwent 2 nights of laboratory polysomnography (PSG) while wearing a fingerless glove under which a stimulating actigraph (""Wakemeter"") was apposed to the palm. The Wakemeter, controlled by a tablet computer, delivered gentle, haptic stimuli every 10 minutes during the sleep period. If a stimulus was detected, the participant squeezed the Wakemeter. Stimulus times, response times and movements were streamed to the tablet. Concurrent PSG data were scored blind to stimuli and responses. Self-reported sleep quality ratings were collected each morning.
RESULTS


The Wakemeter was acceptable to 19 of 20 participants, and effects on self-reported and objective sleep were small. The probability of a response to the stimulus during a wake epoch was high regardless of movement. In contrast, actigraphy magnitude distributions were indistinguishable across epochs scored wake without movement versus sleep, confirming a known limitation of actigraphy. A simple method for calculating sleep efficiency from responses to the stimuli yielded estimates that were highly correlated with PSG-derived estimates (rho = .69, P < .001).
CONCLUSIONS


Behavioral responses to haptic stimuli detected epochs of movement-free wake during the sleep period and may augment actigraphy in the low-burden estimation of sleep efficiency. Acceptability of the method over longer recording periods remains to be established.",2019,"The Wakemeter was acceptable to 19 of 20 participants, and effects on self-reported and objective sleep were small.",['Twenty adults underwent 2 nights of'],"['laboratory polysomnography (PSG) while wearing a fingerless glove under which a stimulating actigraph (""Wakemeter']","['Stimulus times, response times and movements', 'self-reported and objective sleep', 'sleep quality ratings']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0206069', 'cui_str': 'Glove'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",20.0,0.0304956,"The Wakemeter was acceptable to 19 of 20 participants, and effects on self-reported and objective sleep were small.","[{'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Miller', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, Palo Alto, California.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bäbler', 'Affiliation': 'Zühlke Engineering AG, Bogenschützenstrasse 9A, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Maillart', 'Affiliation': 'University of Geneva, Geneva School of Economics and Management and Citizen Cyber Lab, Campus Biotech, Geneva, Switzerland.'}, {'ForeName': 'Afik', 'Initials': 'A', 'LastName': 'Faerman', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, Palo Alto, California.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Woodward', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, Palo Alto, California.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8038']
1494,31740026,Simplified Laparoscopic Suture Rectopexy for Idiopathic Rectal Prolapse In Children: Technique and Results.,"BACKGROUND


Laparoscopic suture rectopexy is safe and effective treatment option for pediatric rectal prolapse. We performed this study to compare the outcome of modified laparoscopic suture rectopexy (MLSR) versus Classical Laparoscopic suture rectopexy (CLSR).
MATERIAL AND METHODS


The study was conducted between June 2015 to May 2019 including all the patients with persistent rectal prolapse who underwent surgery managed by either MLSR (Group A) or CLSR (Group B). The groups were compared for constipation, operative time, blood loss, length of stay, postoperative complications.
RESULTS


19 patients from MLSR and 22 patients from CLSR were evaluated. The mean operative time in MLSR group was 41.5 ± 6.2 min which was significantly lesser than CLSR group with a mean operative time of 78.6 ± 14.2 (p = 0.001). The blood loss was also less in MLSR group compared to CLSR group (p = 0.013). At three months of follow up, the constipation was less in MLSR group compared to CLSR group (p = 0.041).
CONCLUSION


The modification makes the procedure technically easy, minimizes the chances of complications and retaining all the advantages of suture rectopexy.
LEVEL OF EVIDENCE


Level II.",2020,The blood loss was also less in MLSR group compared to CLSR group (p = 0.013).,"['June 2015 to May 2019 including all the patients with persistent rectal prolapse who underwent surgery managed by either MLSR (Group A) or CLSR (Group B', 'Idiopathic Rectal Prolapse', '19 patients from MLSR and 22 patients from CLSR', 'pediatric rectal prolapse']","['CLSR', 'Classical Laparoscopic suture rectopexy (CLSR', 'Simplified Laparoscopic Suture Rectopexy', 'Laparoscopic suture rectopexy', 'modified laparoscopic suture rectopexy (MLSR']","['blood loss', 'constipation', 'constipation, operative time, blood loss, length of stay, postoperative complications', 'mean operative time']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034888', 'cui_str': 'Rectal Prolapse'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0193176', 'cui_str': 'Proctopexy (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.03122,The blood loss was also less in MLSR group compared to CLSR group (p = 0.013).,"[{'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Pandey', 'Affiliation': 'Department of Pediatric Surgery, Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P.. Electronic address: vaibhavpedbhu@gmail.com.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of General Surgery, Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Srivastava', 'Affiliation': 'Department of General Surgery, Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Pediatric Surgery, Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P.'}, {'ForeName': 'Pranay', 'Initials': 'P', 'LastName': 'Panigrahi', 'Affiliation': 'Department of Pediatric Surgery, Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P.'}, {'ForeName': 'Shiv P', 'Initials': 'SP', 'LastName': 'Sharma', 'Affiliation': 'Department of Pediatric Surgery, Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P.'}, {'ForeName': 'Arj D', 'Initials': 'AD', 'LastName': 'Upadhayay', 'Affiliation': 'Department of Pediatric Surgery, Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2019.10.049']
1495,30902396,Clinical trial on the effect of tranexamic acid on bleeding and fibrinolysis in primary hip and knee replacement.,"BACKGROUND


Tourniquet-induced ischaemia could increase fibrinolysis and enhance tranexamic acid (TXA) efficacy in total knee arthroplasty (TKA) compared to total hip arthroplasty (THA). The aims of this study are to compare the effect of TXA on bleeding and fibrinolysis in both types of surgery, and to record thromboembolic complications.
METHODS


A prospective double-blind study was conducted on patients scheduled for TKA or THA who received TXA (2 bolus of 10mg/kg) or placebo. Bleeding and fibrinolysis were evaluated. Doppler-ultrasound and computed tomography were performed in order to assess any thromboembolic complications.
RESULTS


A total of 44 patients were included (11 THA and 11 TKA treated with TXA; 11 THA and 11 TKA as controls). Blood losses were significantly lower in the TXA group (mean 921mL vs 1,383mL in THA and 969mL vs 1,223mL in TKA), and no transfusions were needed with TXA, whereas 5 blood units were transfused in controls. TXA was equally effecting in reducing bleeding in both surgeries (33% in THA and 21% in TKA). The significant mean increase in D-dimers from baseline to 6 hours after surgery (1,004 ug/L to 10,284 ug/L in THA and 571 ug/L to 6,480 ug/L in TKA) was attenuated by TXA (1,077 ug/L to 2,590 ug/L in THA and 655 ug/L to 2,535 ug/L in TKA). There were no differences in thromboembolic episodes.
CONCLUSIONS


Prophylactic use of tranexamic acid is equally effective in reducing bleeding in TKA and THA. Both surgeries have a similar effect on fibrinolysis.",2019,TXA was equally effecting in reducing bleeding in both surgeries (33% in THA and 21% in TKA).,"['patients scheduled for TKA or THA who received', 'A total of 44 patients were included (11 THA and 11 TKA treated with TXA; 11 THA and 11 TKA as controls', 'primary hip and knee replacement', 'total knee arthroplasty (TKA']","['placebo', 'total hip arthroplasty (THA', 'tranexamic acid', 'TXA', 'Doppler-ultrasound and computed tomography']","['bleeding and fibrinolysis', 'bleeding', 'Blood losses', 'fibrinolysis', 'thromboembolic episodes', 'D-dimers', 'Bleeding and fibrinolysis', 'fibrinolysis and enhance tranexamic acid (TXA) efficacy']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",44.0,0.0640602,TXA was equally effecting in reducing bleeding in both surgeries (33% in THA and 21% in TKA).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Alvarez', 'Affiliation': ""Servicio de Anestesia Reanimación y Terapia del Dolor, Parc de Salut MAR, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Universitat Autònoma de Barcelona (UAB), Barcelona, España. Electronic address: 94188@hospitaldelmar.cat.""}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Santiveri', 'Affiliation': ""Servicio de Anestesia Reanimación y Terapia del Dolor, Parc de Salut MAR, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Universitat Autònoma de Barcelona (UAB), Barcelona, España.""}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Ramos', 'Affiliation': ""Servicio de Anestesia Reanimación y Terapia del Dolor, Parc de Salut MAR, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Universitat Autònoma de Barcelona (UAB), Barcelona, España.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gallart', 'Affiliation': ""Servicio de Anestesia Reanimación y Terapia del Dolor, Parc de Salut MAR, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Universitat Autònoma de Barcelona (UAB), Barcelona, España.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Aguilera', 'Affiliation': ""Servicio de Anestesia Reanimación y Terapia del Dolor, Parc de Salut MAR, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Universitat Autònoma de Barcelona (UAB), Barcelona, España.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Puig-Verdie', 'Affiliation': ""Servicio de Cirugía Ortopédica y Traumatología, Parc de Salut MAR, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Universitat Autònoma de Barcelona (UAB), Barcelona, España.""}]",Revista espanola de anestesiologia y reanimacion,['10.1016/j.redar.2019.01.011']
1496,31093649,Pharmacokinetics of tenofovir monoester and association with intracellular tenofovir diphosphate following single-dose tenofovir disoproxil fumarate.,"BACKGROUND


Tenofovir monoester is a relatively lipophilic intermediate formed during the hydrolysis of tenofovir disoproxil to tenofovir. Its clinical pharmacokinetic profile and influence on the cellular pharmacology of tenofovir diphosphate have not been reported.
METHODS


Plasma, PBMC and dried blood spots (DBS) were obtained from HIV-uninfected adults participating in a randomized, cross-over bioequivalence study of single-dose tenofovir disoproxil fumarate (TDF)/emtricitabine unencapsulated or encapsulated with a Proteus® ingestible sensor. Plasma pharmacokinetics of tenofovir monoester and tenofovir were characterized using non-compartmental methods. Relationships with tenofovir diphosphate in DBS and PBMC were examined using mixed-effects models.
RESULTS


Samples were available from 24 participants (13 female; 19 white, 3 black, 2 Hispanic). Tenofovir monoester appeared rapidly with a median (range) Tmax of 0.5 h (0.25-2) followed by a rapid monophasic decline with a geometric mean (coefficient of variation) t½ of 26 min (31.0%). Tenofovir monoester Cmax was 131.6 ng/mL (69.8%) and AUC0-4 was 93.3 ng·h/mL (47.9%). The corresponding values for plasma tenofovir were 222.2 ng/mL (37.1%) and 448.1 ng·h/mL (30.0%). Tenofovir monoester AUC0-∞ (but not tenofovir AUC0-∞) was a significant predictor of tenofovir diphosphate in both PBMC (P = 0.015) and DBS (P = 0.005), increasing by 3.8% (95% CI 0.8%-6.8%) and 4.3% (95% CI 1.5%-7.2%), respectively, for every 10 ng·h/mL increase in tenofovir monoester.
CONCLUSIONS


Tenofovir monoester Cmax and AUC0-4 were 59.2% and 20.6% of corresponding plasma tenofovir concentrations. Tenofovir monoester was significantly associated with intracellular tenofovir diphosphate concentrations in PBMC and DBS, whereas tenofovir concentrations were not. Tenofovir monoester likely facilitates cell loading, thereby increasing tenofovir diphosphate exposures in vivo.",2019,"Tenofovir monoester was significantly associated with intracellular tenofovir diphosphate concentrations in PBMC and DBS, whereas tenofovir concentrations were not.","['24 participants (13 female; 19 white, 3 black, 2 Hispanic']","['tenofovir disoproxil to tenofovir', 'Tenofovir monoester', 'tenofovir', 'tenofovir AUC0-∞', 'intracellular tenofovir diphosphate', 'Tenofovir', 'tenofovir disoproxil fumarate (TDF)/emtricitabine unencapsulated or encapsulated with a Proteus® ingestible sensor', 'tenofovir disoproxil fumarate', 'tenofovir monoester and tenofovir', 'tenofovir diphosphate']","['Tenofovir monoester Cmax', 'Tmax', 'DBS', 'intracellular tenofovir diphosphate concentrations', 'Plasma pharmacokinetics']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}]","[{'cui': 'C0963398', 'cui_str': 'tenofovir disoproxil'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated (qualifier value)'}, {'cui': 'C0033697', 'cui_str': 'Proteus'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.10535,"Tenofovir monoester was significantly associated with intracellular tenofovir diphosphate concentrations in PBMC and DBS, whereas tenofovir concentrations were not.","[{'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Brooks', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Mustafa E', 'Initials': 'ME', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Castillo-Mancilla', 'Affiliation': 'Department of Medicine, School of Medicine, University of Colorado AMC, Aurora, CO, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'MaWhinney', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado AMC, Aurora, CO, USA.'}, {'ForeName': 'Keisha', 'Initials': 'K', 'LastName': 'Alexander', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Tilden', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Becky Jo', 'Initials': 'BJ', 'LastName': 'Kerr', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Ellison', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Cricket', 'Initials': 'C', 'LastName': 'McHugh', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Lane R', 'Initials': 'LR', 'LastName': 'Bushman', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Kiser', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Hosek', 'Affiliation': 'Department of Medicine, Stroger Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Huhn', 'Affiliation': 'Department of Medicine, Stroger Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Anderson', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus (AMC), Aurora, CO, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz187']
1497,31740271,"The effects of nalmefene on emotion processing in alcohol use disorder - A randomized, controlled fMRI study.","Nalmefene is a µ- and δ-opioid receptor antagonist and a partial κ-opioid receptor agonist. The drug is suggested to reduce the craving for, and the consumption of alcohol effectively, also alleviating anxiety and anhedonia. The present fMRI study is the first to investigate the processing of emotions as a possible mechanism of action of nalmefene in humans. Fifteen non-treatment-seeking participants suffering from alcohol use disorder (AUD) (24-66 years; 5 females) finished this randomized, placebo controlled, double blind study. Following a cross over design, participants received either a single dose nalmefene or a placebo, with an interval of one week between sessions. Using fMRI, we investigated neural reactivity during the presentation of emotional faces picture sets. Additionally, we performed a visual dot-probe task to detect nalmefene's effects on attentional bias. We detected an increase in the response to emotional faces in the supramarginal gyrus, the angular gyrus as well as the putamen in the nalmefene vs. placebo condition. However, contradictory to our initial hypotheses, amygdala activation was not altered significantly in the placebo condition - a limitation, which might be associated with a lack of activation in the placebo condition maybe due to the small sample size. Attentional bias analyses revealed an interaction effect by trend, which was driven by a significant effect in a sub-analysis showing increased attentional shift towards happy compared to fearful facial expressions under nalmefene. Nalmefene increased brain activation in areas responsible for empathy, social cognition and behavior, which might help alleviating the reinforcing properties of alcohol.",2019,"We detected an increase in the response to emotional faces in the supramarginal gyrus, the angular gyrus as well as the putamen in the nalmefene vs. placebo condition.",['Fifteen non-treatment-seeking participants suffering from alcohol use disorder (AUD) (24-66 years; 5 females'],"['nalmefene', 'placebo']","['attentional shift towards happy', 'emotion processing', 'brain activation', 'response to emotional faces', 'attentional bias']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0068377', 'cui_str': 'nalmefene'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}]",,0.118707,"We detected an increase in the response to emotional faces in the supramarginal gyrus, the angular gyrus as well as the putamen in the nalmefene vs. placebo condition.","[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Vollstädt-Klein', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany. Electronic address: s.vollstaedt-klein@zi-mannheim.de.'}, {'ForeName': 'J Malte', 'Initials': 'JM', 'LastName': 'Bumb', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany; Feuerlein Center on Translational Addiction Medicine (FCTS), University of Heidelberg, Germany.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Otto', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dinter', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Karl', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Koopmann', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany; Feuerlein Center on Translational Addiction Medicine (FCTS), University of Heidelberg, Germany.'}, {'ForeName': 'Derik', 'Initials': 'D', 'LastName': 'Hermann', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany; Feuerlein Center on Translational Addiction Medicine (FCTS), University of Heidelberg, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Mann', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Kiefer', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany; Feuerlein Center on Translational Addiction Medicine (FCTS), University of Heidelberg, Germany.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.10.014']
1498,31060917,"Efficacy of Single-Shot Adductor Canal Block Combined With Posterior Capsular Infiltration on Postoperative Pain and Functional Outcome After Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Study.","BACKGROUND


Adductor canal block (ACB) may preserve muscle strength and promote faster recovery than other methods of analgesia following total knee arthroplasty (TKA). However, there are contradictory reports on the efficacy of ACB. Here, we evaluated the efficacy of single-shot ACB combined with posterior capsular infiltration (PCI) vs multimodal periarticular infiltration analgesia in treating postoperative pain.
METHODS


This study involved patients undergoing unilateral primary TKA at our institution from January 2018 to January 2019. Patients were randomized into 2 groups, one of which was treated with ACB combined with PCI, and the other with periarticular infiltration analgesia. Primary outcomes included postoperative pain as assessed by the visual analog scale (VAS) and consumption of morphine hydrochloride. The secondary outcome was functional recovery, as assessed by range of knee motion, quadriceps strength, and daily ambulation distance. Tertiary outcomes included the duration of hospital stay and postoperative adverse effects.
RESULTS


Patients treated with ACB and PCI had lower resting VAS scores at 8 and 24 hours after surgery, and lower VAS scores during motion within 48 hours after surgery. Patients treated with ACB and PCI also consumed less morphine. There was no difference in functional recovery, duration of hospitalization, or incidence of adverse events.
CONCLUSION


The ACB combined with PCI can reduce postoperative pain sooner after TKA without affecting postoperative functional recovery and increasing complications.",2019,The ACB combined with PCI can reduce postoperative pain sooner after TKA without affecting postoperative functional recovery and increasing complications.,"['After Total Knee Arthroplasty', 'total knee arthroplasty (TKA', 'patients undergoing unilateral primary TKA at our institution from January 2018 to January 2019']","['single-shot ACB combined with posterior capsular infiltration (PCI) vs multimodal periarticular infiltration analgesia', 'morphine', 'Single-Shot Adductor Canal Block Combined With Posterior Capsular Infiltration', 'ACB and PCI', 'Adductor canal block (ACB', 'ACB combined with PCI', 'PCI']","['duration of hospital stay and postoperative adverse effects', 'postoperative pain sooner', 'functional recovery, duration of hospitalization, or incidence of adverse events', 'VAS scores', 'postoperative pain as assessed by the visual analog scale (VAS) and consumption of morphine hydrochloride', 'Postoperative Pain and Functional Outcome', 'resting VAS scores', 'functional recovery, as assessed by range of knee motion, quadriceps strength, and daily ambulation distance']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0770901', 'cui_str': 'Morphine hydrochloride'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",,0.306296,The ACB combined with PCI can reduce postoperative pain sooner after TKA without affecting postoperative functional recovery and increasing complications.,"[{'ForeName': 'Qiuru', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yue', 'Affiliation': ""Department of Orthopaedics Surgery, Karamay Municipal People's Hospital, Karamay, People's Republic of China.""}, {'ForeName': 'Donghai', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Zhouyuan', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Releken', 'Initials': 'R', 'LastName': 'Yeersheng', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Pengde', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}]",The Journal of arthroplasty,['10.1016/j.arth.2019.03.076']
1499,31079947,Safety and immunogenicity of a vaccine for extra-intestinal pathogenic Escherichia coli (ESTELLA): a phase 2 randomised controlled trial.,"BACKGROUND


ExPEC4V (JNJ-63871860) is a bioconjugate vaccine, containing O-antigens from Escherichia coli serotypes O1A, O2, O6A, and O25B, developed for the prevention of invasive extra-intestinal pathogenic E coli (ExPEC) disease. We aimed to assess safety, reactogenicity, and immunogenicity of ExPEC4V in healthy adults.
METHODS


In this phase 2 randomised, double-blind placebo-controlled study, we recruited healthy adults (≥18 years with a body-mass index of 35 kg/m 2  or less) between Nov 16, 2015, and Aug 8, 2017, and randomly assigned them to receive a single dose of ExPEC4V (antigen O1A:O2:O6A:O25B content 4:4:4:4 μg [group 1]; 4:4:4:8 μg [group 2], 8:8:8:8 μg [group 3], 8:8:8:16 μg [group 4], or 16:16:16:16 μg [group 5]) or placebo. The primary objectives were evaluation of the safety, tolerability, and immunogenicity of ExPEC4V and determination of its dose-dependent immunogenicity 15 days after vaccination by ELISA in individuals who had received at least one vaccination dose. Antibody titres and safety evaluation were used to select two ExPEC4V doses for assessment up to day 360. This trial is registered at ClinicalTrials.gov, number NCT02546960.
FINDINGS


Of 848 enrolled participants, 843 (99%) received the ExPEC4V vaccine (757) or placebo (86) and were included in the safety analysis. Of 757 participants vaccinated with ExPEC4V, 222 (29%) had a solicited local adverse event and 325 (43%) had any solicited systemic adverse event, compared with 11 (13%) and 30 (35%) of 86 participants in the control group. Symptoms were mild-to-moderate. The most frequently reported solicited local adverse event was pain or tenderness (205 [27·1%] of 757 in combined ExPEC4V groups) and the most frequently reported solicited systemic adverse event was fatigue (208 [27·6%] of 757). Only 13 (2%) of 843 had a grade 3 event. At day 15, 80% or more of all participants achieved a two times or greater increase in serotype-specific IgG antibodies (except O25B at the lowest dose, 103 [72%] of 144). At day 360, 66% (95% CI 56·47-74·33) of participants in group 2 and 71% (62·13-78·95) of participants in group 4 selected for long-term follow-up maintained a two times or greater increase in serotype-specific antibody compared with baseline.
INTERPRETATION


EXPEC4V seemed well tolerated and elicited robust and functional antibody responses across all serotypes, doses, and age groups. For the two dosages evaluated (4:4:4:8 μg and 8:8:8:16 μg), the immune response persisted for 1 year.
FUNDING


Janssen Pharmaceuticals.",2019,"At day 360, 66% (95% CI 56·47-74·33) of participants in group 2 and 71% (62·13-78·95) of participants in group 4 selected for long-term follow-up maintained a two times or greater increase in serotype-specific antibody compared with baseline.
","['848 enrolled participants, 843 (99%) received the', 'healthy adults', 'recruited healthy adults (≥18 years with a body-mass index of 35 kg/m 2  or less) between Nov 16, 2015, and Aug 8, 2017']","['ExPEC4V vaccine (757) or placebo', 'placebo', 'vaccine', 'ExPEC4V']","['safety, tolerability, and immunogenicity of ExPEC4V and determination of its dose-dependent immunogenicity 15 days after vaccination by ELISA', 'Safety and immunogenicity', 'Antibody titres and safety evaluation', 'solicited systemic adverse event', 'serotype-specific antibody', 'tolerated and elicited robust and functional antibody responses', 'solicited local adverse event', 'immune response', 'serotype-specific IgG antibodies', 'pain or tenderness', 'safety, reactogenicity, and immunogenicity of ExPEC4V']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}]",848.0,0.679939,"At day 360, 66% (95% CI 56·47-74·33) of participants in group 2 and 71% (62·13-78·95) of participants in group 4 selected for long-term follow-up maintained a two times or greater increase in serotype-specific antibody compared with baseline.
","[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Frenck', 'Affiliation': ""Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. Electronic address: robert.frenck@cchmc.org.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ervin', 'Affiliation': 'Centre for Pharmaceutical Research, Kansas City, MO, USA.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Chu', 'Affiliation': 'Benchmark Clinical Research, Austin, TX, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Abbanat', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Spiessens', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Go', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Haazen', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Germie', 'Initials': 'G', 'LastName': 'van den Dobbelsteen', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Poolman', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Thoelen', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ibarra de Palacios', 'Affiliation': 'Janssen Vaccines, Clinical Development, Bern, Switzerland.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30803-X']
1500,31029515,Safety and immunogenicity of non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine.,"Non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) are frequent pathogens in acute exacerbations of COPD. We assessed the safety, reactogenicity and immunogenicity of different investigational vaccine formulations containing surface proteins of NTHi (PD and PE-PilA) and Mcat (UspA2) in adults with smoking history ≥10 pack-years, to immunologically represent the COPD population. Participants received two doses 60 days apart in a randomised, observer-blind, placebo-controlled study (NCT02547974). In step 1, 30 healthy adults aged 18-40 years were randomised (1:1) to receive a non-adjuvanted formulation (10-10-PLAIN) or placebo. In step 2, 90 smokers/ex-smokers aged 50-70 years randomly (1:1:1) received an AS01-adjuvanted formulation containing either 10 µg of each antigen (10-10-AS01) or 10 µg of each NTHi antigen and 3.3 µg of Mcat antigen (10-3-AS01), or placebo. Incidences of solicited local adverse events (AEs) tended to be highest in the AS01-adjuvanted vaccine groups. Most solicited AEs had mild/moderate intensity. No vaccine-related serious AEs were reported. The 10-3-AS01 formulation induced the best humoral immune response against the NTHi antigens. Responses against the Mcat antigen were similar across groups, with waning immunogenicity after 30 days post-dose 2. The investigational NTHi-Mcat vaccine had an acceptable safety and reactogenicity profile and good immunogenicity in older adults with a smoking history.",2019,The investigational NTHi-Mcat vaccine had an acceptable safety and reactogenicity profile and good immunogenicity in older adults with a smoking history.,"['older adults with a smoking history', '30 healthy adults aged 18-40\u202fyears', '90 smokers/ex-smokers aged 50-70\u202fyears randomly (1:1:1) received an', 'adults with smoking history ≥10 pack-years']","['placebo', 'AS01-adjuvanted formulation containing either 10\u202fµg of each antigen (10-10-AS01) or 10\u202fµg of each NTHi antigen and 3.3\u202fµg of Mcat antigen (10-3-AS01), or placebo', 'non-adjuvanted formulation (10-10-PLAIN) or placebo', 'non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine', 'NTHi (PD and PE-PilA) and Mcat (UspA2']","['Safety and immunogenicity', 'acceptable safety and reactogenicity profile and good immunogenicity', 'humoral immune response', 'safety, reactogenicity and immunogenicity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4555205', 'cui_str': 'Ex-Smokers'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0018483', 'cui_str': 'Haemophilus influenzae'}, {'cui': 'C0026536', 'cui_str': 'Moraxella'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0323968', 'cui_str': 'Pila'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1155229'}]",30.0,0.293994,The investigational NTHi-Mcat vaccine had an acceptable safety and reactogenicity profile and good immunogenicity in older adults with a smoking history.,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Van Damme', 'Affiliation': 'Centre for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Leroux-Roels', 'Affiliation': 'Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Vandermeulen', 'Affiliation': 'Leuven University Vaccinology Centre, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Ryck', 'Affiliation': 'GSK Vaccines, Siena, Italy.'}, {'ForeName': 'Annaelisa', 'Initials': 'A', 'LastName': 'Tasciotti', 'Affiliation': 'GSK Vaccines, Siena, Italy.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Dozot', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Moraschini', 'Affiliation': 'GSK Vaccines, Siena, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Testa', 'Affiliation': 'GSK Vaccines, Siena, Italy. Electronic address: marco.x.testa@gsk.com.'}, {'ForeName': 'Ashwani Kumar', 'Initials': 'AK', 'LastName': 'Arora', 'Affiliation': 'GSK Vaccines, Siena, Italy.'}]",Vaccine,['10.1016/j.vaccine.2019.04.041']
1501,31029516,Comparison of the immunogenicity of Dukoral® oral cholera vaccine between renal transplant recipients on either a calcineurin inhibitor or mycophenolate - A controlled trial.,"BACKGROUND


The evidence for recommendations regarding vaccination in solid organ transplant recipients is sparse. There is little data comparing vaccine responses between groups on different immunosuppressive drugs. This study was conducted to evaluate the antibody response to Dukoral® oral cholera vaccine in renal transplant recipients (RTR).
METHODS


In a single-center non-randomized controlled clinical trial, healthy volunteers (n = 21) and renal transplant recipients (n = 30) were vaccinated with the oral whole cell/recombinant B subunit cholera vaccine Dukoral® (Valneva Inc., Vienna, Austria). The RTR were stratified according to their maintenance immunosuppressive therapy: either prednisone and a calcineurin inhibitor (cyclosporine A or tacrolimus; P/CNI group; n = 15) or prednisone and mycophenolate (P/MMF group; n = 15). All volunteers ingested Dukoral® at baseline and at day 14. Serum samples were drawn at day 0 and day 21. The primary outcome was seroconversion, defined as either a 3-fold IgA serum titer increase in anti-cholera toxin B antibodies and/or a 4-fold rise in the serum vibriocidal titer.
RESULTS


Follow-up was complete. Seroconversion after vaccination was 57% (standard error, SE 9%) in RTR and 81% (SE 9%) in healthy controls (Relative Risk, RR 0.70; 95% CI 0.48-1.02). When stratified according to maintenance immunosuppression, the seroconversion rate was 67% (SE 12%) in the P/CNI group (RR compared with controls 0.82; 95% CI 0.55-1.25) and 47% (SE 13%) in the P/MMF group (RR compared with controls 0.58; 95% CI 0.32-1.03).
CONCLUSION


Adverse events were mild to moderate and transient. The response to Dukoral was weaker and the seroconversion rate was lower in renal transplant recipients than in healthy controls. In particular, those using mycophenolate had a poor response. Nevertheless, more than half of the transplant recipients seroconverted. Therefore oral vaccines should not be discarded as a potential tool for protection of solid organ transplant recipients. This trial is registered in clinicaltrials.gov under NCT01109914.",2019,The response to Dukoral was weaker and the seroconversion rate was lower in renal transplant recipients than in healthy controls.,"['renal transplant recipients on either a', 'renal transplant recipients (RTR', 'healthy volunteers (n\u202f=\u202f21) and renal transplant recipients (n\u202f=\u202f30']","['Dukoral® oral cholera vaccine', 'mycophenolate', 'calcineurin inhibitor or mycophenolate', 'oral whole cell/recombinant B subunit cholera vaccine Dukoral® (Valneva Inc., Vienna, Austria', 'prednisone and a calcineurin inhibitor (cyclosporine A or tacrolimus; P/CNI group; n\u202f=\u202f15) or prednisone and mycophenolate']","['antibody response', 'Adverse events', 'seroconversion rate', 'seroconversion, defined as either a 3-fold IgA serum titer increase in anti-cholera toxin B antibodies', 'serum vibriocidal titer']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3713288', 'cui_str': 'Dukoral'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0008359', 'cui_str': 'Cholera Vaccine'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0008356', 'cui_str': 'Choleragen'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",30.0,0.121818,The response to Dukoral was weaker and the seroconversion rate was lower in renal transplant recipients than in healthy controls.,"[{'ForeName': 'Emile F F', 'Initials': 'EFF', 'LastName': 'Jonker', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Marjolein A C', 'Initials': 'MAC', 'LastName': 'Uijlings', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Leonardus G', 'Initials': 'LG', 'LastName': 'Visser', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Soonawala', 'Affiliation': 'Department of Nephrology, Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine, Haga Teaching Hospital, The Hague, the Netherlands. Electronic address: d.soonawala@lumc.nl.'}]",Vaccine,['10.1016/j.vaccine.2019.04.010']
1502,31736382,Influence of Cooking Workshops on Cooking Skills and Knowledge among Children Attending Summer Day Camps.,"This study aimed to measure the influence of the  Chefs in Action  program (3 cooking workshops) on cooking skills, nutrition knowledge, and attitudes towards healthy eating in children attending summer day camps and compare it with a single cooking workshop. Groups of children (8-12 years) were randomly assigned to the intervention group (n = 25) or to 1 of 3 comparison groups performing a single workshop (group 1, n = 16; group 2, n = 36; group 3, n = 24). Two dietitians evaluated cooking skills during the workshops. Nutrition knowledge and attitudes towards healthy eating were assessed before and after the intervention. No improvement in cooking skills was observed in the intervention group ( P  = 0.25). The intervention group's cooking skills score was significantly higher than comparison group 1 ( P  < 0.001). Nutrition knowledge was significantly improved in the intervention group and the comparison group 3 ( P  < 0.0001) but no effect on attitudes towards healthy eating was observed ( P group × time  = 0.36). In conclusion, the  Chefs in Action  program positively impacted nutrition knowledge in children. The results also suggest that the type of recipe may influence nutrition knowledge and cooking skills. Further studies are needed to better assess the degree of difficulty required in cooking workshop recipes to improve cooking skills in children.",2020,The intervention group's cooking skills score was significantly higher than comparison group 1 ( P  < 0.001).,"['Groups of children (8-12 years', 'children', 'Children Attending Summer Day Camps', 'children attending summer day camps']","['Cooking Workshops', 'Action  program (3 cooking workshops', 'single workshop']","['cooking skills', 'cooking skills score', 'cooking skills, nutrition knowledge, and attitudes towards healthy eating', 'attitudes towards healthy eating', 'Cooking Skills and Knowledge', 'Nutrition knowledge and attitudes towards healthy eating', 'Nutrition knowledge', 'nutrition knowledge and cooking skills']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}]","[{'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}]",,0.0203879,The intervention group's cooking skills score was significantly higher than comparison group 1 ( P  < 0.001).,"[{'ForeName': 'Raphaëlle', 'Initials': 'R', 'LastName': 'Jacob', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Laval University, Quebec, QC.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Motard-Bélanger', 'Affiliation': 'Dairy Farmers of Canada, Montreal, QC.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Provencher', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Laval University, Quebec, QC.'}, {'ForeName': 'Melissa Anne', 'Initials': 'MA', 'LastName': 'Fernandez', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Laval University, Quebec, QC.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Gayraud', 'Affiliation': 'Dairy Farmers of Canada, Montreal, QC.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Drapeau', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Laval University, Quebec, QC.'}]",Canadian journal of dietetic practice and research : a publication of Dietitians of Canada = Revue canadienne de la pratique et de la recherche en dietetique : une publication des Dietetistes du Canada,['10.3148/cjdpr-2019-030']
1503,31067329,Efficacy and safety of ASP1707 for endometriosis-associated pelvic pain: the phase II randomized controlled TERRA study.,"STUDY QUESTION


Does the GnRH antagonist, ASP1707, reduce endometriosis-associated pelvic pain?
SUMMARY ANSWER


ASP1707 significantly reduced endometriosis-associated pelvic pain in a dose-related manner.
WHAT IS KNOWN ALREADY


GnRH agonists are an effective therapeutic option for endometriosis that is refractory to non-steroidal anti-inflammatory drugs, oral contraceptives, and progestins. However, GnRH agonists cause complete suppression of estradiol (E2), resulting in hypoestrogenic side-effects such as bone loss that may increase the future risk of osteoporotic fractures.
STUDY DESIGN, SIZE, DURATION


This was a Phase II, multicenter, double-blind, randomized, parallel-group, placebo-controlled study conducted in 540 women from 04 December 2012 to 30 July 2015 in Europe and Japan. A sample size of 504 (84 subjects per group) was calculated to provide ≥80% power to detect a dose-related treatment effect among placebo and ASP1707 doses in change from baseline in pelvic pain, assuming different dose-response curves after 12 weeks of treatment.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Of 912 women with endometriosis-associated pelvic pain screened, 540 were enrolled, and 532 received ≥1 dose of study drug (placebo, n = 88; ASP1707 3 mg, n = 86; ASP1707 5 mg, n = 91; ASP1707 10 mg, n = 90; ASP1707 15 mg, n = 88; leuprorelin, n = 89) for 24 weeks.
MAIN RESULTS AND THE ROLE OF CHANCE


After 12 weeks of treatment with ASP1707, the mean (95% CI) changes in numeric rating score (NRS) for overall pelvic pain (OPP) were -1.56 (-1.91, -1.21), -1.63 (-1.99, -1.27), -1.93 (-2.27, -1.60), -2.29 (-2.64, -1.94), and -2.13 (-2.47, -1.79) for placebo, ASP1707 3 mg, ASP1707 5 mg, ASP1707 10 mg, and ASP1707 15 mg, respectively. Mean (95% CI) changes in NRS for dysmenorrhea were -1.50 (-2.00, -1.00), -2.72 (-3.22, -2.21), -2.85 (-3.33, -2.38), -3.97 (-4.46, -3.48), and -4.18 (-4.66, -3.70), respectively. Mean (95% CI) changes in NRS for non-menstrual pelvic pain (NMPP) were -1.53 (-1.88, -1.19), -1.51 (-1.87, -1.16), -1.80 (-2.14, -1.47), -2.03 (-2.37, -1.68), and -1.86 (-2.20, -1.52), respectively. Statistically significant dose-related treatment effects in reduction in NRS for OPP (P = 0.001), dysmenorrhea (P < 0.001), and NMPP (P = 0.029) were observed after 12 weeks among ASP1707 doses and were maintained through 24 weeks. Serum estradiol and bone mineral density decreased dose dependently with ASP1707 through 24 weeks, however, to a lesser extent than with leuprorelin.
LIMITATIONS, REASON FOR CAUTION


This study was not powered for pairwise comparison of each ASP1707 group versus placebo.
WIDER IMPLICATIONS OF THE FINDINGS


All doses of ASP1707 reduced serum E2 levels to within the target range and to a lesser extent than leuprorelin. ASP1707 is a potential alternative treatment to leuprorelin for endometriosis-associated pelvic pain with lower impact on bone health.
STUDY FUNDING/COMPETING INTEREST(S)


This study was funded by Astellas Pharma Inc. T.D'.H is Vice President and Head of Global Medical Affairs Fertility at Merck, Darmstadt, Germany since October 1, 2015. At the time that the TERRA study was conducted, he served as Principal Investigator in his role as Coordinator of the Leuven University Fertility Center. Since October 2015, T.D'.H has left Leuven University Hospital Gasthuisberg, but continues to serve as Professor in Reproductive Medicine and Biology at KU Leuven (University of Leuven) Belgium and at the Dept of Obstetrics, Gynecology and Reproduction at Yale University, New Haven, USA. T. Fukaya and Y. Osuga report personal consulting fees from Astellas Pharma Inc. during the conduct of the study and outside the submitted work. G.M. Holtkamp, and L. Skillern are employed by Astellas Pharma Europe B.V.; K. Miyazaki is employed by Astellas Pharma Inc.; B. López, was a biostatistician for Astellas Pharma Europe B.V. during conduct of the study; R. Besuyen was a contract Associate Director of Medical Science for Astellas during conduct of the study.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov, www.clinicaltrials.gov, NCT01767090. EudraCT number 2012-002791-14.
TRIAL REGISTRATION DATE


18 December 2012.
DATE OF FIRST SUBJECT’S ENROLLMENT


One subject signed informed consent on 04 December 2012; the first subject was randomized on 16 April 2013.",2019,"Statistically significant dose-related treatment effects in reduction in NRS for OPP (P = 0.001), dysmenorrhea (P < 0.001), and NMPP (P = 0.029) were observed after 12 weeks among ASP1707 doses and were maintained through 24 weeks.","['18 December 2012', '540 women from 04 December 2012 to 30 July 2015 in Europe and Japan', 'endometriosis-associated pelvic pain', 'Of 912 women with endometriosis-associated pelvic pain screened, 540 were enrolled, and 532 received ≥1 dose of study drug (placebo, n = 88']","['GnRH agonists', 'placebo', 'placebo, ASP1707', 'ASP1707', 'placebo and ASP1707']","['NRS for dysmenorrhea', 'numeric rating score (NRS) for overall pelvic pain (OPP', 'dysmenorrhea', 'serum E2 levels', 'NRS for non-menstrual pelvic pain (NMPP', 'Efficacy and safety', 'Serum estradiol and bone mineral density', 'endometriosis-associated pelvic pain', 'NMPP']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0911329', 'cui_str': 'OPP'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]",540.0,0.225805,"Statistically significant dose-related treatment effects in reduction in NRS for OPP (P = 0.001), dysmenorrhea (P < 0.001), and NMPP (P = 0.029) were observed after 12 weeks among ASP1707 doses and were maintained through 24 weeks.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': ""D'Hooghe"", 'Affiliation': 'Research Group Reproductive Medicine, Department of Development and Regeneration, Organ Systems, Group Biomedical Sciences, KU Leuven (University of Leuven), Belgium.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Fukaya', 'Affiliation': 'Tohoku Medical and Pharmaceutical University, 4-4-1 Komatsushima, Aobaku, Sendai, Miyagi, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Osuga', 'Affiliation': 'The University of Tokyo, Graduate School of Medicine, 7-3-1, Hongo, Bunkyo, Tokyo, Japan.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Besuyen', 'Affiliation': 'Astellas Pharma Europe B.V., Sylviusweg 62, Leiden, the Netherlands.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'López', 'Affiliation': 'Astellas Pharma Europe B.V., Sylviusweg 62, Leiden, the Netherlands.'}, {'ForeName': 'Gertjan M', 'Initials': 'GM', 'LastName': 'Holtkamp', 'Affiliation': 'Astellas Pharma Europe B.V., Sylviusweg 62, Leiden, the Netherlands.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Miyazaki', 'Affiliation': 'Astellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Skillern', 'Affiliation': 'Astellas Pharma Europe B.V., Sylviusweg 62, Leiden, the Netherlands.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez028']
1504,30293544,Effects of Virtual Reality Simulation on Worker Emergency Evacuation of Neonates.,"OBJECTIVE


This study examined differences in learning outcomes among newborn intensive care unit (NICU) workers who underwent virtual reality simulation (VRS) emergency evacuation training versus those who received web-based clinical updates (CU). Learning outcomes included a) knowledge gained, b) confidence with evacuation, and c) performance in a live evacuation exercise.
METHODS


A longitudinal, mixed-method, quasi-experimental design was implemented utilizing a sample of NICU workers randomly assigned to VRS training or CUs. Four VRS scenarios were created that augmented neonate evacuation training materials. Learning was measured using cognitive assessments, self-efficacy questionnaire (baseline, 0, 4, 8, 12 months), and performance in a live drill (baseline, 12 months). Data were collected following training and analyzed using mixed model analysis. Focus groups captured VRS participant experiences.
RESULTS


The VRS and CU groups did not statistically differ based upon the scores on the Cognitive Assessment or perceived self-efficacy. The virtual reality group performance in the live exercise was statistically (P&lt;.0001) and clinically (effect size of 1.71) better than that of the CU group.
CONCLUSIONS


Training using VRS is effective in promoting positive performance outcomes and should be included as a method for disaster training. VRS can allow an organization to train, test, and identify gaps in current emergency operation plans. In the unique case of disasters, which are low-volume and high-risk events, the participant can have access to an environment without endangering themselves or clients. (Disaster Med Public Health Preparedness. 2019;13:301-308).",2019,The VRS and CU groups did not statistically differ based upon the scores on the Cognitive Assessment or perceived self-efficacy.,"['Worker Emergency Evacuation of Neonates', 'newborn intensive care unit (NICU) workers who underwent']","['VRS', 'virtual reality simulation (VRS) emergency evacuation training', 'VRS training or CUs', 'Virtual Reality Simulation']","['cognitive assessments, self-efficacy questionnaire', ' knowledge gained, b) confidence with evacuation, and c) performance in a live evacuation exercise', 'Cognitive Assessment or perceived self-efficacy']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0056599', 'cui_str': 'cpd with unspecified MF of cupric sulfide'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0648502,The VRS and CU groups did not statistically differ based upon the scores on the Cognitive Assessment or perceived self-efficacy.,"[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Farra', 'Affiliation': '1Wright State University,Dayton,Ohio.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hodgson', 'Affiliation': '2Miami University,Miami,Florida.'}, {'ForeName': 'Elaine T', 'Initials': 'ET', 'LastName': 'Miller', 'Affiliation': '3University of Cincinnati,Cincinnati,Ohio.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Timm', 'Affiliation': ""4Cincinnati Children's Hospital and Medical Center,Cincinnati,Ohio.""}, {'ForeName': 'Whittney', 'Initials': 'W', 'LastName': 'Brady', 'Affiliation': ""4Cincinnati Children's Hospital and Medical Center,Cincinnati,Ohio.""}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Gneuhs', 'Affiliation': ""4Cincinnati Children's Hospital and Medical Center,Cincinnati,Ohio.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ying', 'Affiliation': '3University of Cincinnati,Cincinnati,Ohio.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Hausfeld', 'Affiliation': ""4Cincinnati Children's Hospital and Medical Center,Cincinnati,Ohio.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Cosgrove', 'Affiliation': ""4Cincinnati Children's Hospital and Medical Center,Cincinnati,Ohio.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Simon', 'Affiliation': ""4Cincinnati Children's Hospital and Medical Center,Cincinnati,Ohio.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bottomley', 'Affiliation': '1Wright State University,Dayton,Ohio.'}]",Disaster medicine and public health preparedness,['10.1017/dmp.2018.58']
1505,31732062,"Yacon syrup reduces postprandial glycemic response to breakfast: A randomized, crossover, double-blind clinical trial.","Yacon is a root rich in fructooligosaccharides (FOS), which act as prebiotics. Numerous studies have shown promising results in the technological aspects of producing yacon syrup. However, uncertainties exist concerning whether yacon syrup can modulate postprandial glucose and lipid profiles. In order to assess the effect of yacon syrup on postprandial glucose, insulin and triglyceride (TG) responses, a randomized, crossover, double-blind clinical intervention with 40 women (20 normal weight and 20 grade I obese) was performed. Participants underwent two-arms of intervention with at least a one-week wash-out period between visits. On each intervention day, after 12 h of fasting, an aliquot of blood was collected. For intervention A, volunteers consumed breakfast +40 g of placebo, whereas for intervention B, participants consumed breakfast +40 g of yacon syrup (14 g of FOS). Blood samples were drawn at 15, 30, 45, 60, 90, and 120 min. Glucose and insulin concentrations were lowered after yacon syrup intake as compared to placebo at following times: 30 min for glucose and 15, 30 and 45 min for insulin. In conclusion, yacon syrup has a postprandial decreasing effect glucose and insulin concentrations in adult women. This effect was not evident for triglyceride concentration. Clinical trial registry: RBR-33wf46. Available in: http://www.ensaiosclinicos.gov.br/rg/RBR-33wf46/.",2019,"Glucose and insulin concentrations were lowered after yacon syrup intake as compared to placebo at following times: 30 min for glucose and 15, 30 and 45 min for insulin.","['adult women', '40 women (20 normal weight and 20 grade I obese']","['http://www.ensaiosclinicos.gov.br/rg/RBR-33wf46', 'Yacon syrup', 'placebo', 'volunteers consumed breakfast +40\u202fg of placebo', 'breakfast +40\u202fg of yacon syrup', 'yacon syrup']","['postprandial glucose, insulin and triglyceride (TG) responses', 'postprandial glycemic response', 'Glucose and insulin concentrations', 'postprandial glucose and lipid profiles', 'triglyceride concentration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C2713973', 'cui_str': 'yacon syrup'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",20.0,0.252225,"Glucose and insulin concentrations were lowered after yacon syrup intake as compared to placebo at following times: 30 min for glucose and 15, 30 and 45 min for insulin.","[{'ForeName': 'Lia Silveira', 'Initials': 'LS', 'LastName': 'Adriano', 'Affiliation': 'Department of Nutrition, State University of Ceara, 60714-903 Fortaleza, CE, Brazil; Department of Nutrition, University of Fortaleza, 60811-905 Fortaleza, CE, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Dionísio', 'Affiliation': 'Embrapa Agroindústria Tropical, Dra Sara Mesquita Street, 2270, 60511-110 Fortaleza, CE, Brazil. Electronic address: ana.dionisio@embrapa.br.'}, {'ForeName': 'Fernando Antônio Pinto de', 'Initials': 'FAP', 'LastName': 'Abreu', 'Affiliation': 'Embrapa Agroindústria Tropical, Dra Sara Mesquita Street, 2270, 60511-110 Fortaleza, CE, Brazil.'}, {'ForeName': 'Antônio Augusto Ferreira', 'Initials': 'AAF', 'LastName': 'Carioca', 'Affiliation': 'Department of Nutrition, University of Fortaleza, 60811-905 Fortaleza, CE, Brazil.'}, {'ForeName': 'Guilherme Julião', 'Initials': 'GJ', 'LastName': 'Zocolo', 'Affiliation': 'Embrapa Agroindústria Tropical, Dra Sara Mesquita Street, 2270, 60511-110 Fortaleza, CE, Brazil.'}, {'ForeName': 'Nedio Jair', 'Initials': 'NJ', 'LastName': 'Wurlitzer', 'Affiliation': 'Embrapa Agroindústria Tropical, Dra Sara Mesquita Street, 2270, 60511-110 Fortaleza, CE, Brazil.'}, {'ForeName': 'Claudia de Oliveira', 'Initials': 'CO', 'LastName': 'Pinto', 'Affiliation': 'Department of Nutrition, State University of Ceara, 60714-903 Fortaleza, CE, Brazil.'}, {'ForeName': 'Ariclécio Cunha', 'Initials': 'AC', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Nutrition, State University of Ceara, 60714-903 Fortaleza, CE, Brazil.'}, {'ForeName': 'Helena Alves de Carvalho', 'Initials': 'HAC', 'LastName': 'Sampaio', 'Affiliation': 'Department of Nutrition, State University of Ceara, 60714-903 Fortaleza, CE, Brazil.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2019.108682']
1506,31732149,A Randomized Comparison of the Pharmacokinetics and Bioavailability of Fluticasone Propionate Delivered via Xhance Exhalation Delivery System Versus Flonase Nasal Spray and Flovent HFA Inhalational Aerosol.,"PURPOSE


The exhalation delivery system with fluticasone propionate (Xhance®) has been shown to deliver drug substantially more broadly in the nasal cavity (particularly into superior/posterior regions), with less off-target loss of drug to drip-out and swallowing, than conventional nasal sprays. This open-label study evaluated the systemic bioavailability of Xhance® by comparing the pharmacokinetic (PK) properties of a single dose of fluticasone from 3 products administering the drug using 3 different devices: Xhance®, Flonase® (fluticasone propionate inhalational nasal spray), and Flovent® HFA (fluticasone propionate inhalational aerosol).
METHODS


This open-label study was conducted in 2 parts. Study part 1 compared systemic exposure with a single dose of Xhance® 186 or 372 μg versus Flonase® 400 μg (3-way, 3-treatment, 3-sequence, randomized crossover in healthy subjects; n = 90). A separate study, part 2, under the same umbrella protocol, compared systemic exposure with Xhance® 372 μg versus Flovent® HFA 440 μg (2-way, 2-treatment, 2-sequence, randomized crossover in patients with mild to moderate asthma; n = 30).
FINDINGS


With Xhance® 186 μg, the geometric least squares mean (LSM) C max  was higher than with Flonase® 400 μg (16.02 vs 11.66 pg/mL, respectively; geometric mean ratio [GMR], 137.42%) and the geometric LSM AUC 0-∞  values were similar (97.30 vs 99.61 pg · h/mL; GMR, 97.78%). With Xhance® 372 μg, the geometric LSM C max  and AUC 0-∞  were higher than with Flonase® 400 μg (C max , 23.50 vs 11.66 pg/mL [GMR, 201.53%]; AUC 0-∞ , 146.61 vs 99.61 pg · h/mL [GMR, 147.19%]). In part 2, the geometric LSM C max  and AUC 0-∞  values were lower with Xhance® 372 μg than with Flovent® HFA 440 μg (C max , 25.28 vs 40.02 pg/mL [GMR, 63.18%]; AUC 0-∞ , 205.78 vs 415.16 pg · h/mL [GMR, 49.57%]).
IMPLICATIONS


Similar intranasal doses of Xhance® (372 μg) and Flonase® (400 μg) are clearly not bioequivalent. Systemic exposure is very low with all products. Systemic exposure is higher with Xhance® than with Flonase® and substantially lower than with Flovent® HFA 440 μg and, based on dose normalization, Flovent® HFA 220 μg. ClincalTrials.gov identifier: NCT02266927.",2019,"In part 2, the geometric LSM C max  and AUC 0-∞  values were lower with Xhance® 372 μg than with Flovent® HFA 440 μg (C max , 25.28 vs 40.02 pg/mL","['healthy subjects; n\xa0=\xa090', 'ClincalTrials.gov identifier', 'patients with mild to moderate asthma; n\xa0=\xa030']","['Fluticasone Propionate', 'Flonase® (fluticasone propionate inhalational nasal spray), and Flovent® HFA (fluticasone propionate inhalational aerosol', 'Xhance® 186 or 372\xa0μg versus Flonase® 400\xa0μg', 'fluticasone propionate (Xhance®', 'Xhance® 372\xa0μg versus Flovent®', 'fluticasone', 'Xhance®']","['geometric LSM AUC 0-∞  values', 'geometric least squares mean (LSM) C max', 'geometric LSM C max  and AUC 0-∞  values', 'geometric LSM C max  and AUC 0-∞']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0286677', 'cui_str': 'Flonase'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0720466', 'cui_str': 'Flovent'}, {'cui': 'C0001712', 'cui_str': 'Aerosol (substance)'}, {'cui': 'C4529471', 'cui_str': 'Xhance'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.231023,"In part 2, the geometric LSM C max  and AUC 0-∞  values were lower with Xhance® 372 μg than with Flovent® HFA 440 μg (C max , 25.28 vs 40.02 pg/mL","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Messina', 'Affiliation': 'OptiNose US Inc., Yardley, PA, United States. Electronic address: john.messina@optinose.com.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Offman', 'Affiliation': 'Certara, Montreal, Quebec, Canada.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Carothers', 'Affiliation': 'OptiNose US Inc., Yardley, PA, United States.'}, {'ForeName': 'Ramy A', 'Initials': 'RA', 'LastName': 'Mahmoud', 'Affiliation': 'OptiNose US Inc., Yardley, PA, United States.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.09.013']
1507,31614215,"A pragmatic, adaptive clinical trial design for a rare disease: The FOcal Cerebral Arteriopathy Steroid (FOCAS) trial.","BACKGROUND


Pediatric stroke investigators identified as their top research priority a clinical trial of corticosteroids for focal cerebral arteriopathy (FCA). However, FCA is both rare and an acute condition making it infeasible to enroll the large sample sizes needed for standard, confirmatory clinical trials. We present a pragmatic approach to clinical trial design that may inform the approach to other rare disorders.
METHODS


We surveyed pediatric stroke experts to determine the level of evidence that would impact their clinical management of FCA. Incorporating survey results, a randomized, group sequential Bayesian adaptive design was proposed based on a quantitative radiologic outcome measure (change from baseline in change in the FCA Severity Score). Using accumulating information, the design determines whether intervention is better than control with high probability.
RESULTS


Among 21 (100%) respondents, the probability of corticosteroid efficacy that would lead the experts to treat was 30% (median). The probability of efficacy that would make them unwilling to randomize (because they would feel all children should receive corticosteroids) was 70%. Simulation studies with the proposed design showed that a total of 42 subjects controls the type I error rate at the desired level 0.20 and yields a smaller average sample size and trial duration compared to a conventional design.
CONCLUSIONS


Designs in rare diseases require special considerations; this is especially true for this childhood disease, which is both uncommon and acute. This design has incorporated expert consensus to establish the criteria for success, formal monitoring rules for safety, and early stopping rules.",2019,"Simulation studies with the proposed design showed that a total of 42 subjects controls the type I error rate at the desired level 0.20 and yields a smaller average sample size and trial duration compared to a conventional design.
",['42 subjects controls'],['FCA'],['probability of corticosteroid efficacy'],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]",42.0,0.171489,"Simulation studies with the proposed design showed that a total of 42 subjects controls the type I error rate at the desired level 0.20 and yields a smaller average sample size and trial duration compared to a conventional design.
","[{'ForeName': 'Yeonhee', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Fullerton', 'Affiliation': 'Departments of Neurology & Pediatrics, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Jordan J', 'Initials': 'JJ', 'LastName': 'Elm', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, United States. Electronic address: elmj@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105852']
1508,31630445,Weekly adalimumab treatment decreased disease flare in hidradenitis suppurativa over 36 weeks: integrated results from the phase 3 PIONEER trials.,"BACKGROUND


Hidradenitis suppurativa (HS) is a chronic skin disease characterized by inflammatory lesions that flare unpredictably. The impact of weekly adalimumab (ADAew) on HS flare is not well-characterized.
OBJECTIVE


To evaluate the impact of disease flare on health-related quality of life (HRQOL) in moderate-to-severe HS patients and to determine the effect of ADAew on disease flare using integrated data from two phase 3 trials over 36 weeks.
METHODS


In period A (12 weeks), Dermatology Life Quality Index (DLQI) score change from baseline was compared in patients who flared and those who did not, regardless of treatment. The proportion of patients experiencing flare, duration of flare and time to flare was evaluated for ADAew vs. placebo (PBO). In period B (24 weeks), proportion of patients experiencing flare who received continuous ADAew treatment through 36 weeks was assessed.
RESULTS


HRQOL was markedly improved among those who did not experience flare. In period A, the proportion of patients who experienced flare was significantly lower with ADAew vs. PBO (12.3% vs. 35.3%, P < 0.001). ADAew patients also had longer time to first flare (101 days vs. 57 days; P < 0.001) and shorter flare duration (18.9 days vs. 32.0 days, respectively; P = 0.001) vs. PBO. Through 36 weeks of treatment, 20.2% of ADAew patients flared, and for those who achieved at least a partial clinical response to ADAew at 12 weeks, only 5.7% flared.
CONCLUSIONS


Flare reduction is an important measure in HS that correlates with clinically meaningful improvement in HRQOL. ADAew reduces HS flare through 12 and subsequent 36 weeks of treatment.",2020,"ADAew patients also had longer time to first flare (101 days vs. 57 days; P < 0.001) and shorter flare duration (18.9 days vs. 32.0 days, respectively; P = 0.001) vs. PBO.",['moderate-to-severe HS patients'],"['Weekly adalimumab', 'adalimumab (ADAew']","['Dermatology Life Quality Index (DLQI) score change', 'longer time to first flare', 'partial clinical response to ADAew', 'health-related quality of life (HRQOL', 'HRQOL', 'shorter flare duration', 'proportion of patients experiencing flare, duration of flare, and time to flare']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C4706308', 'cui_str': 'Dermatology Life Quality Index score'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.0440113,"ADAew patients also had longer time to first flare (101 days vs. 57 days; P < 0.001) and shorter flare duration (18.9 days vs. 32.0 days, respectively; P = 0.001) vs. PBO.","[{'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'van der Zee', 'Affiliation': 'Department of Dermatology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Longcore', 'Affiliation': 'AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': 'AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'Department of Dermatology, Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, NY, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16023']
1509,31735256,Use of a new composite index to demonstrate improved stereoacuity after training on stimuli with dichoptically asymmetric contrast.,"Many people with stereo-deficiency cannot perform stereoacuity tasks at any binocular disparity, so their threshold cannot be measured. We developed a generally useful new composite stereodepth or CSD score, with range 0 to 20, that combines stereoacuity (from 0 to 13.3) and percent correct (13.3 to 20) into a single index. CSD allows differences in stereodepth performance to be measured across groups when thresholds cannot be reliably measured, and across time when individuals gain stereodepth perception during training. We used CSD scores to assess the benefit of unequal (mixed) left- and right-eye contrast during dichoptic stereoacuity training in people with amblyopia. Nineteen adult participants with anisometropic amblyopia were assigned randomly to 10 sessions of either mixed-contrast or fixed-contrast training. Stimuli were rectangles, one above the other, viewed through a four-mirror stereoscope. Participants indicated which rectangle appeared closer. A staircase controlled disparity within the stimulus. CSD improvement was better by 1.6 CSD units for participants who received mixed-contrast training. Thus, mixed-contrast stereo training was more effective than fixed-contrast training in adults with anisometropic amblyopia.",2020,CSD improvement was better by 1.6 CSD units for participants who received mixed-contrast training.,"['adults with anisometropic amblyopia', 'people with amblyopia', 'Nineteen adult participants with anisometropic amblyopia']","['mixed-contrast or fixed-contrast training', 'unequal (mixed) left- and right-eye contrast during dichoptic stereoacuity training', 'fixed-contrast training']",['CSD improvement'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0339696', 'cui_str': 'Anisometropic Amblyopia'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242503', 'cui_str': 'Inequalities'}, {'cui': 'C0229089', 'cui_str': 'RE - Right eye'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity (observable entity)'}]",[],19.0,0.0410934,CSD improvement was better by 1.6 CSD units for participants who received mixed-contrast training.,"[{'ForeName': 'Cristina Llerena', 'Initials': 'CL', 'LastName': 'Law', 'Affiliation': 'College of Optometry, Nova Southeastern University, 3200 South University Drive, Ft. Lauderdale, FL 33328, USA; SUNY College of Optometry, 33 West 42 Street, New York, NY 10036, USA. Electronic address: lcristin@nova.edu.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Backus', 'Affiliation': 'SUNY College of Optometry, 33 West 42 Street, New York, NY 10036, USA; Vivid Vision, Inc., 525 York St., San Francisco, CA 94110, USA. Electronic address: bbackus@sunyopt.edu.'}]",Vision research,['10.1016/j.visres.2019.10.005']
1510,31067131,The impact of aerobic and isometric exercise on different measures of dysfunctional high-density lipoprotein in patients with hypertension.,"BACKGROUND


Exercise training increases high-density lipoprotein (HDL) cholesterol, but its effect on HDL function is unclear. In hypertensives, exercise improves endothelial dysfunction, which is related to HDL function. In the present study, we assess for the first time the effects of different exercise modalities on two cell-free assays of HDL function.
DESIGN


The study was conducted as a prospective randomized controlled trial in 75 hypertensive patients.
METHODS


Patients were randomized in three groups: (a) handgrip isometric training five times weekly; (b) placebo-handgrip; and (c) aerobic exercise training at least three times per week. HDL function was assessed in serum samples at baseline and after 12 weeks of training by two independent assays that determine the proinflammatory phenotype (haptoglobin content) of a specific amount of HDL (Haptoglobin-HDL [HPHDL]) and oxidized HDL (HDLox) as a measure of reduced antioxidant function of HDL. HDL function measures were normalized by the measures of a pooled control of sera from healthy participants and by HDL-C levels (normalized ratio, no units).
RESULTS


Aerobic exercise led to significant reduction of the HDLox from 0.99 ± 0.27 to 0.90 ± 0.29 (no units,  p  = 0.03). The HPHDL did not change in any training group. Changes of HDLox correlated with reduction of the systolic blood pressure only after aerobic exercise ( R  = 0.64,  p  = 0.03).
CONCLUSIONS


Aerobic but not isometric exercise improves the antioxidant function of HDL in patients with hypertension. This improvement correlates positively with reductions of blood pressure.",2019,"RESULTS


Aerobic exercise led to significant reduction of the HDLox from 0.99 ± 0.27 to 0.90 ± 0.29 (no units, p = 0.03).","['Patients', 'patients with hypertension', '75 hypertensive patients']","['handgrip isometric training five times weekly; (b) placebo-handgrip; and (c) aerobic exercise training', 'aerobic and isometric exercise', 'Aerobic but not isometric exercise', 'Exercise training']","['HDL function', 'blood pressure', 'endothelial dysfunction', 'high-density lipoprotein (HDL) cholesterol', 'proinflammatory phenotype (haptoglobin content) of a specific amount of HDL (Haptoglobin-HDL [HPHDL]) and oxidized HDL (HDLox', 'HDL function measures', 'systolic blood pressure', 'antioxidant function of HDL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0585298', 'cui_str': '5x/wk'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0919773', 'cui_str': 'Haptoglobin'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",75.0,0.0313721,"RESULTS


Aerobic exercise led to significant reduction of the HDLox from 0.99 ± 0.27 to 0.90 ± 0.29 (no units, p = 0.03).","[{'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Pagonas', 'Affiliation': '1 Department of Cardiology, Medical University of Brandenburg, Germany.'}, {'ForeName': 'Stergios', 'Initials': 'S', 'LastName': 'Vlatsas', 'Affiliation': '3 Department of Nephrology, Charité - Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Bauer', 'Affiliation': '2 Medical Department I, Marien Hospital Herne, Ruhr-University of Bochum, Germany.'}, {'ForeName': 'Felix S', 'Initials': 'FS', 'LastName': 'Seibert', 'Affiliation': '2 Medical Department I, Marien Hospital Herne, Ruhr-University of Bochum, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sasko', 'Affiliation': '1 Department of Cardiology, Medical University of Brandenburg, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Buschmann', 'Affiliation': '4 Department of Angiology, Medical University of Brandenburg, Germany.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ritter', 'Affiliation': '1 Department of Cardiology, Medical University of Brandenburg, Germany.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Kelesidis', 'Affiliation': '5 Department of Medicine, David Geffen School of Medicine, University of California, LA, USA.'}, {'ForeName': 'Timm H', 'Initials': 'TH', 'LastName': 'Westhoff', 'Affiliation': '2 Medical Department I, Marien Hospital Herne, Ruhr-University of Bochum, Germany.'}]",European journal of preventive cardiology,['10.1177/2047487319848199']
1511,31060740,A Phase I Study to Show the Relative Bioavailability and Bioequivalence of Fixed-Dose Combinations of Ambrisentan and Tadalafil in Healthy Subjects.,"PURPOSE


Pulmonary arterial hypertension (PAH) is a life-threatening disease that typically causes shortness of breath and exercise intolerance. Combination therapy with ambrisentan and tadalafil has proven to be more effective at preventing clinical failure events in patients with PAH than either drug alone. The aim of this study was to evaluate the bioequivalence of an ambrisentan/tadalafil fixed-dose combination (FDC) compared with co-administration of the 2 monotherapies.
METHODS


This 3-part, randomized, single-dose, open-label crossover study was conducted in healthy volunteers. The first part of the study consisted of a 5-way crossover that compared the relative bioavailability of 4 FDC formulations (10-mg ambrisentan + 40-mg tadalafil) with co-administered reference monotherapies. One formulation was selected and its relative bioavailability was assessed when produced in 3 different granulation sizes during the second part of the study. In the third part of the study, the bioequivalence of the candidate FDC with the reference monotherapies was evaluated for the 10-mg/40-mg dose strength, in addition to 2 other dose strengths (5 mg/20 mg and 5 mg/40 mg). For all parts of the study, blood samples were taken at regular intervals after each dose, ambrisentan and tadalafil concentrations determined, and pharmacokinetic (PK) parameters (C max , AUC 0-∞ , and AUC 0-t ) obtained. Test/reference ratios of the geometric means of PK parameters were used to evaluate bioequivalence. Safety and tolerability were assessed by recording adverse events and monitoring vital signs, ECGs, and clinical laboratory data.
FINDINGS


Of the 174 subjects screened for eligibility, 112 were allocated to a randomized treatment sequence across all study parts, and 100 completed their full assigned treatments. All 4 FDC formulations tested during part 1 of the study yielded PK parameters similar those of the reference treatments. In part 2, granulation size was found to not affect the relative bioavailability of the selected formulation. In part 3, the selected FDC was found to be bioequivalent to co-administration of the monotherapies in both the fasted and fed states. The FDC was also found to be bioequivalent to the reference treatments at the 2 additional dose strengths. All but one of the adverse events was mild to moderate in intensity, and no serious adverse events were reported.
IMPLICATIONS


An ambrisentan/tadalafil FDC was bioequivalent to concurrently administered monotherapies and therefore represents a viable alternative treatment to co-administration. Use of an FDC is likely to be associated with reduced costs and improved patient compliance. ClinicalTrials.gov identifier: NCT02688387.",2019,"In part 3, the selected FDC was found to be bioequivalent to co-administration of the monotherapies in both the fasted and fed states.","['Healthy Subjects', '174 subjects screened for eligibility', 'patients with PAH than either drug alone', 'healthy volunteers']","['Ambrisentan and Tadalafil', 'ambrisentan/tadalafil FDC', 'ambrisentan/tadalafil fixed-dose combination (FDC', 'ambrisentan and tadalafil', 'FDC formulations (10-mg ambrisentan\xa0+\xa040-mg tadalafil']","['ambrisentan and tadalafil concentrations determined, and pharmacokinetic (PK) parameters (C max , AUC 0-∞ , and AUC 0-t ) obtained', 'adverse events and monitoring vital signs, ECGs, and clinical laboratory data', 'Safety and tolerability', 'relative bioavailability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0518766'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",,0.0313455,"In part 3, the selected FDC was found to be bioequivalent to co-administration of the monotherapies in both the fasted and fed states.","[{'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Okour', 'Affiliation': 'Clinical Pharmacology Modeling and Simulation, GlaxoSmithKline, Upper Providence, PA, USA. Electronic address: malek.x.okour@gsk.com.'}, {'ForeName': 'Adeep', 'Initials': 'A', 'LastName': 'Puri', 'Affiliation': 'Hammersmith Medicines Research Ltd, London, United Kingdom.'}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Port', 'Affiliation': 'GSK Medicines Research Centre, Stevenage, United Kingdom.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Berni', 'Affiliation': 'GlaxoSmithKline, West Uxbridge, United Kingdom.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Khindri', 'Affiliation': 'GlaxoSmithKline, West Uxbridge, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Schneider', 'Affiliation': 'GlaxoSmithKline, Cambridge, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tenero', 'Affiliation': 'Clinical Pharmacology Modeling and Simulation, GlaxoSmithKline, Upper Providence, PA, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.04.007']
1512,31056442,Virtual Reality Simulation Facilitates Resident Training in Total Hip Arthroplasty: A Randomized Controlled Trial.,"BACKGROUND


No study has yet assessed the efficacy of virtual reality (VR) simulation for teaching orthopedic surgery residents. In this blinded, randomized, and controlled trial, we asked if the use of VR simulation improved postgraduate year (PGY)-1 orthopedic residents' performance in cadaver total hip arthroplasty and if the use of VR simulation had a preferentially beneficial effect on specific aspects of surgical skills or knowledge.
METHODS


Fourteen PGY-1 orthopedic residents completed a written pretest and a single cadaver total hip arthroplasty (THA) to establish baseline levels of knowledge and surgical ability before 7 were randomized to VR-THA simulation. All participants then completed a second cadaver THA and retook the test to assess for score improvements. The primary outcomes were improvement in test and cadaver THA scores.
RESULTS


There was no significant difference in the improvement in test scores between the VR and control groups (P = .078). In multivariate regression analysis, the VR cohort demonstrated a significant improvement in overall cadaver THA scores (P = .048). The VR cohort demonstrated greater improvement in each specific score category compared with the control group, but this trend was only statistically significant for technical performance (P = .009).
CONCLUSIONS


VR-simulation improves PGY-1 resident surgical skills but has no significant effect on medical knowledge. The most significant improvement was seen in technical skills. We anticipate that VR simulation will become an indispensable part of orthopedic surgical education, but further study is needed to determine how best to use VR simulation within a comprehensive curriculum.
LEVEL OF EVIDENCE


Level 1.",2019,There was no significant difference in the improvement in test scores between the VR and control groups (P = .078).,"['teaching orthopedic surgery residents', 'Fourteen PGY-1 orthopedic residents completed a', 'Total Hip Arthroplasty', ""postgraduate year (PGY)-1 orthopedic residents' performance in cadaver total hip arthroplasty""]","['virtual reality (VR) simulation', 'written pretest and a single cadaver total hip arthroplasty (THA', 'VR simulation', 'Virtual Reality Simulation Facilitates', 'Resident Training']","['medical knowledge', 'improvement in test and cadaver THA scores', 'specific score category', 'technical skills', 'test scores', 'overall cadaver THA scores', 'technical performance']","[{'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",14.0,0.05656,There was no significant difference in the improvement in test scores between the VR and control groups (P = .078).,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hooper', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Tsiridis', 'Affiliation': 'Aristotle University Medical School, Department of Orthopedic Surgery, Papageorgiou General Hospital, Thessaloniki, Hellas; Center of Orthopaedics and Regenerative Medicine (C.O.RE.)- C.I.R.I.-A.U.Th., Balkan Center, Hellas, Greece.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Feng', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Schwarzkopf', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Waren', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Long', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}, {'ForeName': 'Lazaros', 'Initials': 'L', 'LastName': 'Poultsides', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Macaulay', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Department of Orthopedic Surgery, New York University Langone Health, New York, NY.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.04.002']
1513,31058977,"A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study of a Replication-Defective Herpes Simplex Virus (HSV) Type 2 Vaccine, HSV529, in Adults With or Without HSV Infection.","BACKGROUND


Herpes simplex virus 2 (HSV2) causes genital herpes in >400 million persons worldwide.
METHODS


We conducted a randomized, double-blinded, placebo-controlled trial of a replication-defective HSV2 vaccine, HSV529. Twenty adults were enrolled in each of 3 serogroups of individuals: those negative for both HSV1 and HSV2 (HSV1-/HSV2-), those positive or negative for HSV1 and positive for HSV2 (HSV1±/HSV2+), and those positive for HSV1 and negative for HSV2 (HSV1+/HSV2-). Sixty participants received vaccine or placebo at 0, 1, and 6 months. The primary end point was the frequency of solicited local and systemic reactions to vaccination.
RESULTS


Eighty-nine percent of vaccinees experienced mild-to-moderate solicited injection site reactions, compared with 47% of placebo recipients (95% confidence interval [CI], 12.9%-67.6%; P = .006). Sixty-four percent of vaccinees experienced systemic reactions, compared with 53% of placebo recipients (95% CI, -17.9% to 40.2%; P = .44). Seventy-eight percent of HSV1-/HSV2- vaccine recipients had a ≥4-fold increase in neutralizing antibody titer after 3 doses of vaccine, whereas none of the participants in the other serogroups had such responses. HSV2-specific CD4+ T-cell responses were detected in 36%, 46%, and 27% of HSV1-/HSV2-, HSV1±/HSV2+, and HSV1+/HSV2- participants, respectively, 1 month after the third dose of vaccine, and CD8+ T-cell responses were detected in 14%, 8%, and 18% of participants, respectively.
CONCLUSIONS


HSV529 vaccine was safe and elicited neutralizing antibody and modest CD4+ T-cell responses in HSV-seronegative vaccinees.
CLINICAL TRIALS REGISTRATION


NCT01915212.",2019,"Sixty-four percent of vaccinees experienced systemic reactions compared with 53% of placebo recipients (p = 0.44, 95%CI -0.179, 0.402).","['Twenty adults each enrolled in three serogroups, HSV1 /HSV2 , HSV1 /HSV2 , and HSV1 /HSV2 , received', 'Adults With or Without HSV Infection', 'Herpes simplex virus 2 (HSV2) causes genital herpes in over 400 million persons worldwide']","['vaccine or placebo', 'placebo', 'HSV529 vaccine', 'HSV1 /HSV2 vaccine', 'Placebo', 'replication-defective HSV2 vaccine, HSV529']","['moderate solicited injection site reactions', 'HSV2-specific CD4+ T-cell responses', 'CD8+ T-cell responses', 'safe and elicited neutralizing antibody and modest CD4+ T-cell responses', 'systemic reactions', 'neutralizing antibody titer', 'frequency of solicited local and systemic reactions to vaccination']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0019348', 'cui_str': 'Herpes Simplex Virus Infection'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019342', 'cui_str': 'Herpes Simplex Virus Genital Infection'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",20.0,0.700411,"Sixty-four percent of vaccinees experienced systemic reactions compared with 53% of placebo recipients (p = 0.44, 95%CI -0.179, 0.402).","[{'ForeName': 'Lesia K', 'Initials': 'LK', 'LastName': 'Dropulic', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.'}, {'ForeName': 'Makinna C', 'Initials': 'MC', 'LastName': 'Oestreich', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.'}, {'ForeName': 'Harlan L', 'Initials': 'HL', 'LastName': 'Pietz', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Laing', 'Affiliation': 'Department of Medicine, School of Medicine, University of Washington.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunsberger', 'Affiliation': 'Biostatistics Research Branch, NIAID, NIH, Rockville.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Lumbard', 'Affiliation': 'Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute, NIH, Frederick, Maryland.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Garabedian', 'Affiliation': 'Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute, NIH, Frederick, Maryland.'}, {'ForeName': 'Siu Ping', 'Initials': 'SP', 'LastName': 'Turk', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.'}, {'ForeName': 'Aiying', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Global Biostatistics and Programming, Pennsylvania.'}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Hornung', 'Affiliation': 'Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute, NIH, Frederick, Maryland.'}, {'ForeName': 'Chetan', 'Initials': 'C', 'LastName': 'Seshadri', 'Affiliation': 'Department of Medicine, School of Medicine, University of Washington.'}, {'ForeName': 'Malisa T', 'Initials': 'MT', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, School of Medicine, University of Washington.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Hosken', 'Affiliation': 'Department of Medicine, School of Medicine, University of Washington.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Phogat', 'Affiliation': 'New Vaccines Portfolio Strategy and Execution, Pennsylvania.'}, {'ForeName': 'Lee-Jah', 'Initials': 'LJ', 'LastName': 'Chang', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur, Swiftwater, Pennsylvania.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Koelle', 'Affiliation': 'Department of Medicine, School of Medicine, University of Washington.'}, {'ForeName': 'Kening', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Cohen', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz225']
1514,31088728,Incremental risk of cardiovascular disease and/or chronic kidney disease for future ASCVD and mortality in patients with type 2 diabetes mellitus: ACCORD trial.,"BACKGROUND


Cardiovascular disease (CVD) and chronic kidney disease (CKD) are complications of type 2 diabetes mellitus (DM). Current cholesterol guidelines recommend the same prevention strategy for patients with DM alone as patients with DM + CKD. However, the incremental risk of these common complications for incident cardiovascular disease and mortality has not been well studied.
METHODS


We compared the incremental risk of having DM + CKD, DM + CVD and DM + CVD + CKD in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial participants for incident CVD as the primary outcome and all-cause mortality.
RESULTS


After a mean (SD) follow up of 4.7(1.4) years, 1,046(10%) participants developed CVD. DM +vCKD, DM + CVD, and DM + CKD + CVD had a significantly increased risk of the primary outcome compared to DM alone [adjusted hazard ratio(95%CI): 1.41 (1.06-1.89), p = 0.02; 2.20 (1.92-2.53), p < 0.001); 2.35 (1.81-3.04), p < 0.001), respectively]. All-cause mortality had a graded increased risk compared to the reference group [adjusted hazard ratio(95%CI): 1.39 (1.01-1.90), p = 0.04; 1.29 (1.51-2.12), p < 0.0001; 2.36 (1.75-3.13), p < 0.0001), respectively].
CONCLUSION


Our post hoc analysis shows an incremental graded risk for CVD outcomes and all-cause mortality with the development of CKD and/or CVD in individuals with DM.",2019,"All-cause mortality had a graded increased risk compared to the reference group [adjusted hazard ratio(95%CI): 1.39 (1.01-1.90), p = 0.04; 1.29 (1.51-2.12), p < 0.0001; 2.36 (1.75-3.13), p < 0.0001), respectively].
","['individuals with DM', 'patients with DM alone as patients with DM\u202f+\u202fCKD', 'patients with type 2 diabetes mellitus']",[],['CVD'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",[],[],,0.426223,"All-cause mortality had a graded increased risk compared to the reference group [adjusted hazard ratio(95%CI): 1.39 (1.01-1.90), p = 0.04; 1.29 (1.51-2.12), p < 0.0001; 2.36 (1.75-3.13), p < 0.0001), respectively].
","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Branch', 'Affiliation': 'Heart and Vascular Center of Excellence, Wake Forest Baptist Health, Winston Salem, NC, United States of America. Electronic address: mbranch@wakehealth.edu.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'German', 'Affiliation': 'Heart and Vascular Center of Excellence, Wake Forest Baptist Health, Winston Salem, NC, United States of America.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Bertoni', 'Affiliation': 'Department of Epidemiology and Public Health, Wake Forest Baptist Health, Winston Salem, NC, United States of America.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Yeboah', 'Affiliation': 'Heart and Vascular Center of Excellence, Wake Forest Baptist Health, Winston Salem, NC, United States of America.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.04.004']
1515,31087313,Role of Oropharyngeal Administration of Colostrum in Very Low Birth Weight Infants for Reducing Necrotizing Enterocolitis: A Randomized Controlled Trial.,"OBJECTIVE


This study aimed to study the role of oropharyngeal administration of colostrum (OAC) in very-low-birth-weight infants for reducing necrotizing enterocolitis (NEC).
STUDY DESIGN


In this randomized controlled trial, 117 infants were enrolled, 59 were randomized to OAC group and 58 to routine care group. Infants with birth weight ≤ 1,250 g and/or gestational age ≤ 30 weeks were enrolled. Infants in OAC group received maternal colostrum (0.2 mL), 0.1 mL on either side, after 24 hours of postnatal life and were given every 2 hour for the next 72 hours irrespective of the enteral feeding status of the neonate. The primary outcome of the study was the incidence of NEC (stage 2 or 3).
RESULTS


Baseline characteristics were comparable between the two groups. There was no significant reduction in the incidence of NEC in OAC group (0 [0%] vs. 3 [7.1%];  p  = 0.11). There was significant reduction of 7 days of hospital stay in OAC group (34.2 ± 5.7 vs. 41.5 ± 6.7 days;  p  = 0.04).The incidence of early-onset sepsis, late-onset sepsis, blood culture positive sepsis, and ventilator-associated pneumonia were comparable between the two groups.
CONCLUSION


OAC is safe and reduces the duration of hospital stay.",2020,"There was significant reduction of 7 days of hospital stay in OAC group (34.2 ± 5.7 vs. 41.5 ± 6.7 days;  p  = 0.04).The incidence of early-onset sepsis, late-onset sepsis, blood culture positive sepsis, and ventilator-associated pneumonia were comparable between the two groups.
","['very-low-birth-weight infants for reducing necrotizing enterocolitis (NEC', 'and/or gestational age\u2009≤\u200930 weeks were enrolled', '117 infants were enrolled, 59 were randomized to OAC group and 58 to routine care group', 'Infants with birth weight\u2009≤\u20091,250\u2009g']","['oropharyngeal administration of colostrum (OAC', 'maternal colostrum', 'Oropharyngeal Administration of Colostrum']","['hospital stay', 'incidence of NEC (stage 2 or 3', 'early-onset sepsis, late-onset sepsis, blood culture positive sepsis, and ventilator-associated pneumonia', 'duration of hospital stay', 'Necrotizing Enterocolitis', 'incidence of NEC']","[{'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}]","[{'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0740299', 'cui_str': 'Blood culture positive for microorganism'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}]",117.0,0.190344,"There was significant reduction of 7 days of hospital stay in OAC group (34.2 ± 5.7 vs. 41.5 ± 6.7 days;  p  = 0.04).The incidence of early-onset sepsis, late-onset sepsis, blood culture positive sepsis, and ventilator-associated pneumonia were comparable between the two groups.
","[{'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Neonatology, National Institute of Medical Science, Jaipur, Rajasthan, India.'}, {'ForeName': 'Amandeep', 'Initials': 'A', 'LastName': 'Kaur', 'Affiliation': 'Department of Pediatrics, National Institute of Medical Science, Jaipur, Rajasthan, India.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Farahbakhsh', 'Affiliation': ""Department of Pediatric Pulmonology, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'Helping Hand Polyclinic, Jaipur, Rajasthan, India.'}]",American journal of perinatology,['10.1055/s-0039-1688817']
1516,29861076,Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial.,"BACKGROUND


Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue.
METHODS


We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008-000625-19, and ClinicalTrials.gov, number NCT01288794.
FINDINGS


From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40-0·95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3-4 non-liver related adverse events.
INTERPRETATION


In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis.
FUNDING


Italian Medicine Agency.",2018,"p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40-0·95]).","['From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis', '38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group', '33 academic and non-academic Italian hospitals', 'patients with decompensated cirrhosis', 'patients with cirrhosis and uncomplicated ascites who were treated with', 'patients With hEpatic ciRrhosis']","['anti-aldosteronic drugs', 'standard medical treatment (SMT) or SMT plus HA ', 'SMT', 'furosemide']","['18-month mortality, evaluated as difference of events and analysis of survival time', 'Overall 18-month survival', 'mortality hazard ratio', 'overall survival']","[{'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1619727', 'cui_str': 'Decompensated cirrhosis of liver (disorder)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",440.0,0.289158,"p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40-0·95]).","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Caraceni', 'Affiliation': 'Department of Medical and Surgical Sciences, and Center for Applied Biomedical Research, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Oliviero', 'Initials': 'O', 'LastName': 'Riggio', 'Affiliation': 'Department of Clinical Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Angeli', 'Affiliation': 'Unit of Internal Medicine and Hepatology, Department of Medicine, University of Padua, Padua, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Alessandria', 'Affiliation': 'Division of Gastroenterology and Hepatology, Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Neri', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Francesco G', 'Initials': 'FG', 'LastName': 'Foschi', 'Affiliation': 'Internal Medicine, Hospital of Faenza, Azienda Unità Sanitaria Locale of Romagna, Faenza, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Levantesi', 'Affiliation': 'Internal Medicine, Hospital of Bentivoglio, AUSL of Bologna, Bologna, Italy.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Airoldi', 'Affiliation': 'Liver Unit, Department of Hepatology and Gastroenterology, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Boccia', 'Affiliation': 'Gastroenterology Unit, University Hospital, Ferrara, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Svegliati-Baroni', 'Affiliation': 'Department of Gastroenterology, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Fagiuoli', 'Affiliation': 'Gastroenterology and Transplant Hepatology, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Roberto G', 'Initials': 'RG', 'LastName': 'Romanelli', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Cozzolongo', 'Affiliation': 'Division of Gastroenterology, National Institute of Gastroenterology S De Bellis, Castellana Grotte (Bari), Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Di Marco', 'Affiliation': 'Unit of Gastroenterology and Hepatology, Biomedical Department of Internal and Specialistic Medicine, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Sangiovanni', 'Affiliation': 'Azienda Ospedaliera di Rilievo Nazionale dei Colli, Cotugno Hospital of Naples, Naples, Italy.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Morisco', 'Affiliation': 'Gastroenterology Unit, Department of Clinical Medicine and Surgery, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Toniutto', 'Affiliation': 'Internal Medicine, Department of Medical Area, University of Udine, Udine, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Tortora', 'Affiliation': 'Gastroenterology, Gemelli Foundation, Catholic University, Rome, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'De Marco', 'Affiliation': 'Gastroenterology Unit, Hospital of Cosenza, Cosenza, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Angelico', 'Affiliation': 'Liver Unit, Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cacciola', 'Affiliation': 'Division of Clinical and Molecular Hepatology, University Hospital of Messina, Messina, Italy.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Elia', 'Affiliation': 'Infectious Diseases and Hepatology, University Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Federico', 'Affiliation': 'Department of Clinical and Experimental Internal Medicine, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Massironi', 'Affiliation': ""Gastroenterology and Endoscopy Unit, Foundation Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Guarisco', 'Affiliation': 'Internal Medicine, S Sebastiano General Hospital, Frascati (Rome), Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Galioto', 'Affiliation': 'Internal Medicine, Hospital of Dolo, Azienda Unità Locale Socio-sanitaria Serenissima, Mestre, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Ballardini', 'Affiliation': 'Internal Medicine, Hospital of Rimini, AUSL of Romagna, Rimini, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rendina', 'Affiliation': 'Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Nardelli', 'Affiliation': 'Department of Clinical Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Piano', 'Affiliation': 'Unit of Internal Medicine and Hepatology, Department of Medicine, University of Padua, Padua, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Elia', 'Affiliation': 'Division of Gastroenterology and Hepatology, Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Prestianni', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Federica Mirici', 'Initials': 'FM', 'LastName': 'Cappa', 'Affiliation': 'Internal Medicine, Hospital of Faenza, Azienda Unità Sanitaria Locale of Romagna, Faenza, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Cesarini', 'Affiliation': 'Liver Unit, Department of Hepatology and Gastroenterology, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Simone', 'Affiliation': 'Gastroenterology Unit, University Hospital, Ferrara, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Pasquale', 'Affiliation': 'Department of Clinical Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cavallin', 'Affiliation': 'Unit of Internal Medicine and Hepatology, Department of Medicine, University of Padua, Padua, Italy.'}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Andrealli', 'Affiliation': 'Division of Gastroenterology and Hepatology, Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Fidone', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Ruggeri', 'Affiliation': 'Graduate School of Health Economics and Management, Catholic University, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Roncadori', 'Affiliation': 'Cineca Interuniversity Consortium, Bologna, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Baldassarre', 'Affiliation': 'Department of Medical and Surgical Sciences, and Center for Applied Biomedical Research, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Tufoni', 'Affiliation': 'Department of Medical and Surgical Sciences, and Center for Applied Biomedical Research, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Zaccherini', 'Affiliation': 'Department of Medical and Surgical Sciences, and Center for Applied Biomedical Research, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Bernardi', 'Affiliation': 'Department of Medical and Surgical Sciences, and Center for Applied Biomedical Research, University of Bologna, Bologna, Italy. Electronic address: mauro.bernardi@unibo.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(18)30840-7']
1517,31738342,"Enteropathogens and Rotavirus Vaccine Immunogenicity in a Cluster Randomized Trial of Improved Water, Sanitation and Hygiene in Rural Zimbabwe.","BACKGROUND


Oral rotavirus vaccines (RVVs) are less efficacious in low-income versus high-income settings, plausibly due to more enteropathogen exposure through poor water, sanitation and hygiene (WASH). We explored associations between enteropathogens and RVV immunogenicity and evaluated the effect of improved WASH on enteropathogen carriage.
METHODS


We detected stool enteropathogens using quantitative molecular methods and measured anti-rotavirus immunoglobulin A by enzyme-linked immunosorbent assay in infants enrolled to a cluster randomized 2 × 2 factorial trial of improved WASH and improved infant feeding in Zimbabwe (NCT01824940). We used multivariable regression to explore associations between enteropathogens and RVV seroconversion, seropositivity and geometric mean titer. We evaluated effects of improved WASH on enteropathogen prevalence using linear and binomial regression models with generalized estimating equations.
RESULTS


Among 224 infants with enteropathogen and immunogenicity data, 107 (47.8%) had ≥1 pathogen and 39 (17.4%) had ≥2 pathogens detected at median age 41 days (interquartile range: 35-54). RVV seroconversion was low (23.7%). After adjusting for Sabin-poliovirus quantity, pan-enterovirus quantity was positively associated with RVV seroconversion (relative risk 1.61 per 10-fold increase in pan-enterovirus; 95% confidence interval: 1.35-1.91); in the same model, Sabin quantity was negatively associated with RVV seroconversion (relative risk: 0.76; 95% confidence interval: 0.60-0.96). There were otherwise no meaningful associations between individual or total pathogens (bacteria, viruses, parasites or all pathogens) and any measure of RVV immunogenicity. Enteropathogen detection did not differ between randomized WASH and non-WASH groups.
CONCLUSIONS


Enteropathogen infections were common around the time of rotavirus vaccination in rural Zimbabwean infants but did not explain poor RVV immunogenicity and were not reduced by a package of household-level WASH interventions.",2019,"After adjusting for Sabin-poliovirus quantity, pan-enterovirus quantity was positively associated with RVV seroconversion (relative risk 1.61 per 10-fold increase in pan-enterovirus; 95% confidence interval: 1.35-1.91); in the same model, Sabin quantity was negatively associated with RVV seroconversion (relative risk: 0.76; 95% confidence interval: 0.60-0.96).","['224 infants with enteropathogen and immunogenicity data, 107 (47.8%) had ≥1 pathogen and 39 (17.4%) had ≥2 pathogens detected at median age 41 days (interquartile range: 35-54', 'rural Zimbabwean infants', 'Rural Zimbabwe']","['WASH', 'quantitative molecular methods and measured anti-rotavirus immunoglobulin A by enzyme-linked immunosorbent assay', 'Oral rotavirus vaccines (RVVs']","['enteropathogens and RVV seroconversion, seropositivity and geometric mean titer', 'Enteropathogen detection', 'RVV seroconversion', 'RVV immunogenicity']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1562052', 'cui_str': 'Enteropathogen'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}]","[{'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C1562052', 'cui_str': 'Enteropathogen'}]",224.0,0.235107,"After adjusting for Sabin-poliovirus quantity, pan-enterovirus quantity was positively associated with RVV seroconversion (relative risk 1.61 per 10-fold increase in pan-enterovirus; 95% confidence interval: 1.35-1.91); in the same model, Sabin quantity was negatively associated with RVV seroconversion (relative risk: 0.76; 95% confidence interval: 0.60-0.96).","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Church', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Rogawski McQuade', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Kuda', 'Initials': 'K', 'LastName': 'Mutasa', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Taniuchi', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Rukobo', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Govha', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Vaccine Testing Center, College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Marya P', 'Initials': 'MP', 'LastName': 'Carmolli', 'Affiliation': 'Vaccine Testing Center, College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chasekwa', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ntozini', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'McNeal', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Moulton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Vaccine Testing Center, College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Houpt', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Jean H', 'Initials': 'JH', 'LastName': 'Humphrey', 'Affiliation': 'From the Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Platts-Mills', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Prendergast', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002485']
1518,31076203,"Safety, Tolerability, and Pharmacokinetics of a New Formulation of Nemiralisib Administered via a Dry Powder Inhaler to Healthy Individuals.","PURPOSE


Nemiralisib, a phosphoinositide 3-kinase δ inhibitor, is being investigated as an immunomodulatory agent with anti-inflammatory properties in chronic obstructive pulmonary disease. This study evaluated the pharmacokinetic (PK) properties and safety of a new formulation of nemiralisib that contains 0.4% magnesium stearate.
METHODS


In this randomized, double-blind, parallel-group study, healthy individuals received a single dose of 500 or 750 μg of nemiralisib administered via the Ellipta dry powder inhaler (DPI) (n = 6 in each treatment group). Aerodynamic particle size distribution (APSD) data comparing previous and new formulations were available before the study. Serial PK analyses for plasma exposure and safety assessments were performed during the first 24 h after dosing, with follow-up measurements on days 3 and 6 in clinic.
FINDINGS


APSD had increases of approximately 6-fold and 2-fold in very fine particle mass and fine particle mass over the previous (Diskus) formulation. In humans, systemic exposure (AUC) was greater after inhalation of 750 versus 500 μg of nemiralisib (AUC 0-t : 17,200 h∙pg/mL; 95% CI, 10,900-27,200 h∙pg/mL and 13,100; 95% CI, 8130-21,000 h∙pg/mL, respectively). A low frequency of individual adverse events and no serious adverse events were reported after both doses.
IMPLICATIONS


After single-dose inhalation of 500 and 750 μg of nemiralisib from the Ellipta DPI in healthy individuals, plasma PK data were well defined, and as predicted based on previous PK and APSD data, exposure was increased with the new formulation. Nemiralisib was well tolerated with no new safety issues identified. These data supported progression of nemiralisib to a Phase IIb study in patients with chronic obstructive pulmonary disease. ClinicalTrials.gov identifier: NCT03189589.",2019,"FINDINGS


APSD had increases of approximately 6-fold and 2-fold in very fine particle mass and fine particle mass over the previous (Diskus) formulation.","['patients with chronic obstructive pulmonary disease', 'chronic obstructive pulmonary disease', 'healthy individuals', 'Healthy Individuals']","['magnesium stearate', 'Nemiralisib Administered via a Dry Powder Inhaler', 'nemiralisib administered via the Ellipta dry powder inhaler (DPI']","['pharmacokinetic (PK) properties and safety', 'systemic exposure (AUC', 'plasma PK data', 'Safety, Tolerability, and Pharmacokinetics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0126791', 'cui_str': 'Magnesium stearate'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3853847', 'cui_str': 'Dry Powder Inhaler'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",,0.197292,"FINDINGS


APSD had increases of approximately 6-fold and 2-fold in very fine particle mass and fine particle mass over the previous (Diskus) formulation.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': 'GlaxoSmithKline, Stevenage, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Templeton', 'Affiliation': 'GlaxoSmithKline, Stevenage, United Kingdom.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Leemereise', 'Affiliation': 'GlaxoSmithKline, Zeist, the Netherlands.'}, {'ForeName': 'Rhena', 'Initials': 'R', 'LastName': 'Eames', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Banham-Hall', 'Affiliation': 'GlaxoSmithKline, Clinical Unit Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Edith M', 'Initials': 'EM', 'LastName': 'Hessel', 'Affiliation': 'GlaxoSmithKline, Stevenage, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'GlaxoSmithKline, Stevenage, United Kingdom. Electronic address: tony.x.cahn@gsk.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.04.008']
1519,31072506,Left Circumflex Coronary Artery After Left Main Crossover Stenting: Jailed Yet Mostly Innocent.,,2019,,[],['Left Circumflex Coronary Artery'],[],[],"[{'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]",[],,0.0225528,,"[{'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'de la Torre Hernández', 'Affiliation': 'Hospital Universitario Marques de Valdecilla, Servicio de Cardiología, Unidad de Cardiología Intervencionista, IDIVAL, Santander, Spain. Electronic address: he1thj@humv.es.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.03.015']
1520,31072505,5-Year Outcomes According to FFR of Left Circumflex Coronary Artery After Left Main Crossover Stenting.,"OBJECTIVES


The aim of the current study was to evaluate the long-term clinical impact of fractional flow reserve (FFR) in jailed left circumflex coronary artery (LCx) after left main coronary artery (LM) simple crossover stenting.
BACKGROUND


Although the provisional side-branch intervention with FFR guidance has been validated for non-LM bifurcation lesions, the outcome of such a strategy in LM bifurcation disease is not well-known.
METHODS


Patients who underwent LM-to-left anterior descending coronary artery simple crossover stenting and who had FFR measurements in the LCx thereafter were enrolled. A low FFR was defined as ≤0.80. The clinical outcomes were assessed by the 5-year rate of target lesion failure (TLF) (a composite of cardiac death, target-vessel myocardial infarction, or target lesion revascularization).
RESULTS


In 83 patients, the mean FFR of the LCx after LM stenting was 0.87 ± 0.08, and 14 patients (16.9%) had a low FFR. There was no correlation between the FFR and angiographic % diameter stenosis in jailed LCx (R 2  = 0.039; p = 0.071) and there was no difference in the angiographic % diameter stenosis in the high and low FFR groups. At 5 years, the low FFR group had a significantly higher rate of TLF than the high FFR group (33.4% vs. 10.7%; hazard ratio: 4.09, 95% confidence interval: 1.15 to 14.52; p = 0.029). However, there was no difference in the clinical outcomes according to the angiographic % diameter stenosis. In a multivariate analysis, a low FFR was an independent predictor of the risk for a 5-year TLF (hazard ratio: 6.49; 95% confidence interval: 1.37 to 30.73; p = 0.018).
CONCLUSIONS


The patients with a high FFR in jailed LCx had better 5-year outcomes than those with a low FFR. The FFR measurement in jailed LCx can be helpful in selecting an adequate treatment strategy and may reduce unnecessary complex procedures.",2019,"At 5 years, the low FFR group had a significantly higher rate of TLF than the high FFR group (33.4% vs. 10.7%; hazard ratio: 4.09, 95% confidence interval: 1.15 to 14.52; p = 0.029).","['Patients who underwent LM-to-left anterior descending coronary artery simple crossover stenting and who had FFR measurements in the LCx thereafter were enrolled', 'jailed left circumflex coronary artery (LCx) after left main coronary artery (LM']",['fractional flow reserve (FFR'],"['mean FFR of the LCx', '5-year outcomes', '5-Year Outcomes', '5-year rate of target lesion failure (TLF) (a composite of cardiac death, target-vessel myocardial infarction, or target lesion revascularization', 'rate of TLF', 'FFR and angiographic % diameter stenosis in jailed LCx', 'angiographic % diameter stenosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441998', 'cui_str': 'Left anterior (qualifier value)'}, {'cui': 'C0205386', 'cui_str': 'Descending (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}]",,0.0841255,"At 5 years, the low FFR group had a significantly higher rate of TLF than the high FFR group (33.4% vs. 10.7%; hazard ratio: 4.09, 95% confidence interval: 1.15 to 14.52; p = 0.029).","[{'ForeName': 'Cheol Hyun', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea.'}, {'ForeName': 'Sang-Woong', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea.'}, {'ForeName': 'Jongmin', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea.'}, {'ForeName': 'In-Cheol', 'Initials': 'IC', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea.'}, {'ForeName': 'Yun-Kyeong', 'Initials': 'YK', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea.'}, {'ForeName': 'Hyoung-Seob', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea.'}, {'ForeName': 'Hyuck-Jun', 'Initials': 'HJ', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea.'}, {'ForeName': 'Hyungseop', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea.'}, {'ForeName': 'Seongwook', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Keimyung University Dongsan Hospital, Daegu, South Korea.'}, {'ForeName': 'Joo Myung', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joon-Hyung', 'Initials': 'JH', 'LastName': 'Doh', 'Affiliation': 'Department of Medicine, Inje University Ilsan Paik Hospital, Goyang, South Korea.'}, {'ForeName': 'Eun-Seok', 'Initials': 'ES', 'LastName': 'Shin', 'Affiliation': 'Department of Cardiology, Ulsan Hospital, Ulsan, South Korea.'}, {'ForeName': 'Bon-Kwon', 'Initials': 'BK', 'LastName': 'Koo', 'Affiliation': 'Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Hur', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea.'}, {'ForeName': 'Chang-Wook', 'Initials': 'CW', 'LastName': 'Nam', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea. Electronic address: ncwcv@dsmc.or.kr.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.02.037']
1521,30896356,"Impact of exercise-induced hypohydration on gastrointestinal integrity, function, symptoms, and systemic endotoxin and inflammatory profile.","It is commonly believed that gastrointestinal issues during exercise are exacerbated by hypohydration. This study aimed to determine the effect of exercise-induced hypohydration on gastrointestinal integrity, function, symptoms, and systemic endotoxin and inflammatory profiles. In a randomized crossover design, male endurance runners ( n  = 11) performed 2 h of running at 70% of maximum oxygen uptake in 25°C ambient temperature with water provision [euhydration (EuH)] and total water restriction [hypohydration (HypoH)] during running, which accounted for 0.6 ± 0.6% and 3.1 ± 0.7% body mass loss, respectively. Blood and fecal samples were collected before and after exercise. Breath samples (H 2  determination) were collected and gastrointestinal symptoms (GIS) recorded before, during, and after exercise. HypoH resulted in a higher, yet insignificant, ∆ preexercise to postexercise plasma cortisol concentration (+286 nmol/l vs. +176 nmol/l;  P  = 0.098) but significantly higher intestinal fatty acid-binding protein (I-FABP) (+539 pg/ml vs. +371 pg/ml;  P  = 0.047) concentration compared with EuH. A greater breath H 2  response ( P  = 0.026) was observed on HypoH (1,188 ppm/3 h, peak +12 ppm) vs. EuH (579 ppm/3 h, peak +6 ppm). Despite greater GIS incidence on HypoH (82%) vs. EuH (64%), GIS severity scores were not significant between trials. Exercise-induced leukocytosis (overall pre- to postexercise: 5.9 × 10 9 /l to 12.1 × 10 9 /l) was similar on both trials. Depressed in vitro neutrophil function was observed during recovery on HypoH (-36%) but not on EUH (+6%). A pre- to postexercise increase ( P  < 0.05) was observed for circulating cytokine concentrations but not endotoxin values. Hypohydration during 2 h of running modestly perturbs gastrointestinal integrity and function and increases GIS incidence but does not affect systemic endotoxemia and cytokinemia.  NEW & NOTEWORTHY  Despite anecdotal beliefs that exercise-induced hypohydration exacerbates perturbations to gastrointestinal status, the present study reports only modest perturbations in gastrointestinal integrity, function, and symptoms compared with euhydration maintenance. Exercise-induced hypohydration does not exacerbate systemic endotoxemia and cytokinemia compared with euhydration maintenance. Programmed water intake to maintain euhydration results in gastrointestinal symptom severity similar to exercise-induced hypohydration. Maintaining euhydration during exertional stress prevents the exercise-associated depression in bacterially stimulated neutrophil function.",2019,"HypoH resulted in a higher, yet insignificant, ∆ preexercise to postexercise plasma cortisol concentration (+286 nmol/l vs. +176 nmol/l;  P  = 0.098) but significantly higher intestinal fatty acid-binding protein (I-FABP) (+539 pg/ml vs. +371 pg/ml;  P  = 0.047) concentration compared with EuH. A greater breath H 2  response ( P  = 0.026) was observed on HypoH (1,188 ppm/3 h, peak +12 ppm) vs. EuH (579 ppm/3 h, peak +6 ppm).",['male endurance runners ( n  = 11'],"['performed 2 h of running at 70% of maximum oxygen uptake in 25°C ambient temperature with water provision [euhydration (EuH)] and total water restriction [hypohydration (HypoH', 'exercise-induced hypohydration', 'Exercise-induced hypohydration']","['gastrointestinal integrity and function and increases GIS incidence', 'gastrointestinal integrity, function, symptoms, and systemic endotoxin and inflammatory profile', 'circulating cytokine concentrations', '∆ preexercise to postexercise plasma cortisol concentration', 'intestinal fatty acid-binding protein', 'gastrointestinal integrity, function, symptoms, and systemic endotoxin and inflammatory profiles', 'vitro neutrophil function', 'GIS severity scores', 'Exercise-induced leukocytosis', 'Blood and fecal samples']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake (observable entity)'}, {'cui': 'C0542496', 'cui_str': 'Ambient temperature (observable entity)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0163314', 'cui_str': 'Fatty Acid-Binding Proteins, Intestinal-Specific'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0023518', 'cui_str': 'Leukocytosis'}, {'cui': 'C0005768'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",,0.0910886,"HypoH resulted in a higher, yet insignificant, ∆ preexercise to postexercise plasma cortisol concentration (+286 nmol/l vs. +176 nmol/l;  P  = 0.098) but significantly higher intestinal fatty acid-binding protein (I-FABP) (+539 pg/ml vs. +371 pg/ml;  P  = 0.047) concentration compared with EuH. A greater breath H 2  response ( P  = 0.026) was observed on HypoH (1,188 ppm/3 h, peak +12 ppm) vs. EuH (579 ppm/3 h, peak +6 ppm).","[{'ForeName': 'Ricardo J S', 'Initials': 'RJS', 'LastName': 'Costa', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria , Australia.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Camões-Costa', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria , Australia.'}, {'ForeName': 'Rhiannon M J', 'Initials': 'RMJ', 'LastName': 'Snipe', 'Affiliation': 'Centre for Sport Research, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria , Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dixon', 'Affiliation': 'Writtle University College , Chelmsford , United Kingdom.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Russo', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria , Australia.'}, {'ForeName': 'Zoya', 'Initials': 'Z', 'LastName': 'Huschtscha', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria , Australia.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.01032.2018']
1522,31067347,"Metastatic prostate cancer at diagnosis and through progression in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.","BACKGROUND


The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial assessed the effect of screening with prostate-specific antigen and a digital rectal examination on prostate cancer mortality. Another endpoint of interest was the burden of total metastatic disease.
METHODS


All men in PLCO were assessed for metastatic prostate cancer at diagnosis; men with clinical stage I/II disease were assessed for metastatic progression. The rate of total metastatic disease was defined as metastases found either at diagnosis or through progression divided by person-years (PYs) of follow-up for all men in the trial. Metastatic progression rates were computed among men with clinical stage I/II prostate cancer. Survival among men with metastases at diagnosis was compared with survival among men with metastatic progression.
RESULTS


Among 38,340 men in the intervention arm and 38,343 men in the control arm in PLCO, there were 4974 and 4699 prostate cancer cases, respectively. The rates of total metastatic disease were 4.72 and 4.83 per 10,000 PYs in the intervention and control arms, respectively (rate ratio, 0.98; 95% CI, 0.81-1.18). The rates of metastatic progression among men with clinical stage I/II prostate cancer were 43.7 and 50.5 per 10,000 PYs in the intervention and control arms, respectively (P = .30). Prostate cancer-specific 5- and 10-year survival rates were significantly worse for men with metastatic progression (24% and 19%, respectively) than men with metastases at diagnosis (40% and 26%, respectively).
CONCLUSIONS


Rates of total metastatic disease and metastatic progression were similar across arms in PLCO. Survival was worse for men with metastatic progression in comparison with those with metastatic disease at diagnosis.",2019,"Prostate cancer-specific 5- and 10-year survival rates were significantly worse for men with metastatic progression (24% and 19%, respectively) than men with metastases at diagnosis (40% and 26%, respectively).
","['men with clinical stage I/II prostate cancer', '38,340 men in the intervention arm and 38,343 men in the control arm in PLCO, there were 4974 and 4699 prostate cancer cases, respectively']",['screening with prostate-specific antigen and a digital rectal examination'],"['total metastatic disease and metastatic progression', 'prostate cancer mortality', 'rates of metastatic progression', 'Survival', 'metastatic prostate cancer', 'Metastatic progression rates', 'Prostate cancer-specific 5- and 10-year survival rates', 'burden of total metastatic disease', 'rate of total metastatic disease', 'rates of total metastatic disease']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205564', 'cui_str': 'Clinical stage I (finding)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1384593', 'cui_str': 'Digital Rectal Examination'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.130027,"Prostate cancer-specific 5- and 10-year survival rates were significantly worse for men with metastatic progression (24% and 19%, respectively) than men with metastases at diagnosis (40% and 26%, respectively).
","[{'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Pinsky', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Black', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Daugherty', 'Affiliation': 'Patient-Centered Outcomes Research Institute, Washington, DC.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hoover', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Parnes', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'Smith', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Eggener', 'Affiliation': 'University of Chicago School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'Andriole', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Sonja I', 'Initials': 'SI', 'LastName': 'Berndt', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.'}]",Cancer,['10.1002/cncr.32176']
1523,30207423,A behaviour change intervention with lipid-based nutrient supplements had little impact on young child feeding indicators in rural Kenya.,"Poor infant and young child feeding (IYCF) practices are associated with linear growth faltering. Our objective was to evaluate the impact of a nutrition and water and sanitation for health intervention on three IYCF indicators-minimum dietary diversity (MDD), minimum meal frequency (MMF), and minimum acceptable diet (MAD) in Kenyan children. Households were randomized into one of eight groups: (a) active control; (b) passive control; (c) water quality (W); (d) sanitation (S); (e) handwashing (H); (f) combined Water, Sanitation, and Handwashing; (g) nutrition (N); and (h) combined WSH + N. In the N and WSH + N arms, community-based promoters counselled households on optimal IYCF practices, and small-quantity lipid-based nutrient supplements (SQ-LNS) were provided to children 6-24 months of age. Twelve months (Year 1) and 24 months (Year 2) after interventions began, enumerators surveyed mothers to ascertain IYCF practices. We made pairwise comparisons of each intervention arm versus the active control arm using log binomial models. In total, 3,652 caretakers were surveyed at Year 1 and 4,987 caretakers at Year 2. Compared with the active control, there were no differences in any of the arms in MDD, MMF, or MAD, aside from an increase in MDD at Year 1 in the nutrition only arm but not in the combined WSH + N arm (N: 68%; WSH + N: 61%; C: 61%; N arm prevalence ratio: 1.13 95% CI [1.01, 1.25]). In this setting, a nutrition behaviour change communication intervention had little impact on IYCF indicators. The provision of SQ-LNS was not detrimental to current IYCF indicators in the community.",2019,"Compared with the active control, there were no differences in any of the arms in MDD, MMF, or MAD, aside from an increase in MDD at Year 1 in the nutrition only arm but not in the combined WSH ","['3,652 caretakers were surveyed at Year 1 and 4,987 caretakers at Year 2', 'young child feeding indicators in rural Kenya', 'Kenyan children']","['active control; (b) passive control; (c) water quality (W); (d) sanitation (S); (e) handwashing (H); (f) combined Water, Sanitation, and Handwashing; (g) nutrition (N); and (h) combined WSH\xa0+\xa0N', 'lipid-based nutrient supplements', 'nutrition and water and sanitation for health intervention']","['IYCF indicators-minimum dietary diversity (MDD), minimum meal frequency (MMF), and minimum acceptable diet (MAD', 'MDD, MMF, or MAD, aside from an increase in MDD']","[{'cui': 'C0335350', 'cui_str': 'Building caretaker'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0597680', 'cui_str': 'Water Quality'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",3652.0,0.0701926,"Compared with the active control, there were no differences in any of the arms in MDD, MMF, or MAD, aside from an increase in MDD at Year 1 in the nutrition only arm but not in the combined WSH ","[{'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Byrd', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California.'}, {'ForeName': 'Holly N', 'Initials': 'HN', 'LastName': 'Dentz', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Department of Global Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Kiprotich', 'Affiliation': 'Innovations for Poverty Action, Kakamega, Kenya.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Pickering', 'Affiliation': 'Department of Civil and Environmental Engineering, Tufts University, Medford, Massachusetts.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Omondi', 'Affiliation': 'Center for International Policy Research, Mathematica Policy Research, Washington, District of Columbia.'}, {'ForeName': 'Osborne', 'Initials': 'O', 'LastName': 'Kwena', 'Affiliation': 'Center for International Policy Research, Mathematica Policy Research, Washington, District of Columbia.'}, {'ForeName': 'Gouthami', 'Initials': 'G', 'LastName': 'Rao', 'Affiliation': 'Innovations for Poverty Action, Kakamega, Kenya.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Colford', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California.'}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Null', 'Affiliation': 'Innovations for Poverty Action, Kakamega, Kenya.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California.'}]",Maternal & child nutrition,['10.1111/mcn.12660']
1524,31062207,Effect of Therapeutic Touch on Sleep Quality in Elders Living at Nursing Homes.,"This study was carried out to investigate the effect of therapeutic touch on sleep quality in the elderly people living in the nursing homes. The study is a randomized controlled experimental study (pretest-posttest control group). The sample of the research consisted of 25 elderly people. As a result of the study, although there was a significant increase (p < 0.05) in the sleep quality of each group, no significant difference was found between the groups (p > 0.05). Therapeutic touch is an effective method of improving the sleep quality of the elders living at a nursing home.",2020,"As a result of the study, although there was a significant increase (p < 0.05) in the sleep quality of each group, no significant difference was found between the groups (p > 0.05).","['elderly people living in the nursing homes', 'Elders Living at Nursing Homes', '25 elderly people', 'elders living at a nursing home']",['Therapeutic Touch'],"['Sleep Quality', 'sleep quality']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",25.0,0.0148947,"As a result of the study, although there was a significant increase (p < 0.05) in the sleep quality of each group, no significant difference was found between the groups (p > 0.05).","[{'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Bağcı', 'Affiliation': 'Department of Fundamentals Nursing, Ege University Nursing School, 35000, Izmir, Turkey. hazelbagci@hotmail.com.'}, {'ForeName': 'Şebnem', 'Initials': 'Ş', 'LastName': 'Çınar Yücel', 'Affiliation': 'Department of Fundamentals Nursing, Ege University Nursing School, 35000, Izmir, Turkey.'}]",Journal of religion and health,['10.1007/s10943-019-00831-9']
1525,31090748,Evaluation of internal and external hexagon connections in immediately loaded full-arch rehabilitations: A within-person randomised split-mouth controlled trial.,"PURPOSE


To evaluate if a different morphology of the implant-abutment connection (internal vs. external hexagon) is able to condition the behaviour of hard and soft peri-implant tissues.
MATERIALS AND METHODS


Twenty patients with significantly unfavourable prognoses for their residual maxillary or mandibular dentitions were selected and rehabilitated with immediately loaded fixed full-arch rehabilitations in two different centres. Four to six implants with identical macro- and micro-topography were inserted in each arch: external hexagon implants (EHC) in one randomly selected side of the dental arch and internal hexagon implants (IHC) in the other side. Primary outcome measures were the success rates of the implants and prostheses. Any technical and biological complication was recorded. Secondary outcome measures were: peri-implant marginal bone level (MBL) changes, Plaque Index (PI), probing depth (PD) and bleeding on probing (BoP), evaluated at implant insertion and at 3, 6 and 12 months post-loading.
RESULTS


Forty-three EHC and 40 IHC implants were inserted in 20 patients. No patients dropped out. Two implants failed; one IHC after 3 months and one EHC after 6 months in two different patients (difference IHC vs. EHC at patient level: 0.06%; 95% CI: -1.9 to 2.1; P = 0.99). No prosthesis failed. No biological complications were identified and three loose prosthetic abutment screws were identified in three different patients (two EHC and one IHC); difference at patient level IHC vs. EHC: 2.1% (95% CI: -0.8 to 5; P = 0.43). Overall marginal bone loss was not significantly different between the two treatment groups (EHC vs. IHC) at any time point. The mean difference of bone levels between EHC and IHC was 0.25 mm (95% CI: -0.18 to 0.69) at implant placement. Mean difference between IHC and EHC was -0.01 mm (95% CI: -0.34 to 0.36) at 3 months, 0.13 mm (95% CI: -0.48 to 0.22) at 6 months and 0.11 mm (95% CI: -0.45 to 0.25) at 12 months. All the implants showed good periodontal health at the 1-year-in-function visit, with no statistically significant differences between groups. At 12 months mean (± standard deviation) PI was 2 (± 1.5) for the EHC and 1.85 (± 1.58) for the IHC group (P = 0.57) with a mean difference between the two groups of 0.15 (95% CI: -0.56 to 0.85). Mean PD was 2.23 mm (± 0.52) for the EHC and 2.10 mm (± 0.39) for the IHC group (P = 0.39), with a mean difference between the two groups of 0.12 mm (95% CI: -0.08 to 0.33). At 12 months 41.4% of EHC and 43.6% of IHC implants presented no BoP (mean difference: -2.2%, 95% CI: -24.0 to 19.3; P = 0.51). No significant effect of centres over all outcomes was identified (P = 0.71 for MBL, P = 0.14 for PI, P = 0.14 for PD and P = 0.20 for BoP).
CONCLUSIONS


On the basis of the present trial the two types of implant connections were clinically reliable. After 12 months in function, both implants provided good clinical outcomes, without statistically significant differences between the two groups.",2019,Overall marginal bone loss was not significantly different between the two treatment groups (EHC vs. IHC) at any time point.,"['Forty-three EHC and 40 IHC implants were inserted in 20 patients', 'Twenty patients with significantly unfavourable prognoses for their residual maxillary or mandibular dentitions were selected and rehabilitated with immediately loaded fixed full-arch rehabilitations in two different centres']","['internal and external hexagon connections', 'external hexagon implants (EHC', 'implant-abutment connection (internal vs. external hexagon']","['biological complications', 'Mean PD', 'Overall marginal bone loss', 'success rates of the implants and prostheses', 'bone levels', 'good periodontal health', 'loose prosthetic abutment screws', 'peri-implant marginal bone level (MBL) changes, Plaque Index (PI), probing depth (PD) and bleeding on probing (BoP), evaluated at implant insertion and at 3, 6 and 12 months post-loading']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0011443', 'cui_str': 'Dentition'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0443225', 'cui_str': 'Full (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0524929', 'cui_str': 'Prosthetic Implants'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205407', 'cui_str': 'Loose (qualifier value)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",20.0,0.215931,Overall marginal bone loss was not significantly different between the two treatment groups (EHC vs. IHC) at any time point.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Menini', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pesce', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bagnasco', 'Affiliation': ''}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Carossa', 'Affiliation': ''}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Mussano', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pera', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1526,31090749,Natural or palatal positioning of immediate post-extractive implants in the aesthetic zone? Three-year results of a multicentre randomised controlled trial.,"PURPOSE


To evaluate whether there is a difference in aesthetic outcomes positioning immediate post-extractive implants in the natural position (where the tooth should have been in relation to adjacent teeth/implants) or approximately 3 mm more palatally.
MATERIALS AND METHODS


Just after tooth extraction, 20 patients requiring one single immediate maxillary post-extractive implant, from second premolar to second premolar, were randomly allocated to receive either an implant positioned in the natural 'central' position where the tooth should have been (central group; 10 patients) or approximately 3 mm more palatally (palatal group; 10 patients) according to a parallel-group design at two different centres. When needed, sites were reconstructed and bone-to-implant gaps were filled with granules of anorganic bovine bone, covered by resorbable collagen barriers. Implants were left submerged for 4 months and rehabilitated with provisional crowns, replaced after 4 months by metal-ceramic definitive crowns. Patients were followed to 3 years after loading. Outcome measures were: crown and implant failures, complications, aesthetics assessed using the pink aesthetic score (PES), peri-implant marginal bone level changes and patient satisfaction, recorded by blinded assessors.
RESULTS


Three patients from each group dropped out up to 3 years after loading. One implant failed in each group (14%), the difference being not statistically significant (difference in proportion = 0.00; 95% CI: -0.39 to 0.39; P = 1.000). Two palatal group patients and one natural position patient had a complication each, the difference being not statistically significant (difference in proportion = 0.14; 95% CI: -0.28 to 0.52; P = 1.000). Three years after loading, the median PES was 12.5 (interquartile range [IQR] 5.0) for the central and 10.0 (IQR 10.0) for the palatal group, the difference being not statistically significant (median difference = -1.5; 95% CI: -10.0 to 5.0; P = 0.476). Three years after loading, patients of the central group lost 0.25 (IQR 0.40) mm of peri-implant marginal bone and those of the palatal group 0.20 (IQR 0.88) mm, the difference being not statistically significant (median difference = 0.15 mm; P [Mann-Whitney U test] = 0.486). Patients of both groups were equally satisfied at 3 years after loading for both function and aesthetics (both P = 0.699).
CONCLUSIONS


These preliminary results suggest that positioning of immediate post-extractive implants 3 mm more palatally may not improve aesthetics; however, the sample size of the present study was very limited, thus larger trials are needed to confirm or reject the present findings. Conflict of interest statement: Mozo-Grau, Valladolid, Spain, the manufacturer of the implants used in this investigation, donated the implants and partially supported this trial; however, data belonged to the authors and by no means did the sponsor interfere with the conduct of the trial or the publication of its results.",2019,"Patients of both groups were equally satisfied at 3 years after loading for both function and aesthetics (both P = 0.699).
","['20 patients requiring one single immediate maxillary post-extractive implant, from second premolar to second premolar', 'Just after tooth extraction']","[""implant positioned in the natural 'central' position where the tooth should have been (central group; 10 patients) or approximately 3 mm more palatally (palatal group; 10 patients) according to a parallel-group design"", 'Natural or palatal positioning of immediate post-extractive implants']","['crown and implant failures, complications, aesthetics assessed using the pink aesthetic score (PES), peri-implant marginal bone level changes and patient satisfaction, recorded by blinded assessors', 'median PES', 'aesthetics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0040440', 'cui_str': 'Tooth Extraction'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0854676', 'cui_str': 'Failure of implant'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0332585', 'cui_str': 'Pink color (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",20.0,0.138744,"Patients of both groups were equally satisfied at 3 years after loading for both function and aesthetics (both P = 0.699).
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peñarrocha-Oltra', 'Affiliation': ''}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Peñarrocha-Diago', 'Affiliation': ''}, {'ForeName': 'Raúl Fernández', 'Initials': 'RF', 'LastName': 'Encinas', 'Affiliation': ''}, {'ForeName': 'Daniela Rita', 'Initials': 'DR', 'LastName': 'Ippolito', 'Affiliation': ''}, {'ForeName': 'Erta', 'Initials': 'E', 'LastName': 'Xhanari', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Esposito', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1527,31090750,Accuracy of computer-assisted template-based implant placement using conventional impression and scan model or intraoral digital impression: A randomised controlled trial with 1 year of follow-up.,"PURPOSE


To compare accuracy and complications of computer-assisted template-based implant placement using conventional impression and scan of a physical stone cast or intraoral scanning to rehabilitate partially edentulous patients.
MATERIALS AND METHODS


Any partially edentulous patients with at least five residual teeth, requiring at least one implant to be planned on three-dimensional (3D) cone beam computed tomography (CBCT) scan according to a computer-assisted template-based protocol were enrolled. Patients were randomised according to a parallel-group design into two arms: intraoral digital impression (fully digital group) or conventional impression and scan model (conventional group). Implants were placed flapless or with a minimally invasive flap, and conventionally loaded after 5 months. Outcome measures were implant and prosthetic success, complications, accuracy and peri-implant marginal bone loss. Three deviation parameters (angular, horizontal and vertical) were defined to evaluate the discrepancy between the planned and placed implant positions. Results were compared using a mixed-model repeated-measures analysis of variance (α = 0.05).
RESULTS


Twenty patients (11 females and 9 males; mean age 44.6 years old) were randomised to the fully digital group (10 patients with 28 implants) or conventional group (10 patients with 29 implants). No patients dropped out. No implant or prosthesis failed up to 1 year after loading. One implant in the fully digital group was placed freehand due to limited inter-arch space. No biological or mechanical complications were experienced during follow-up. Difference between groups were not statistically significant (P = 0.999). The mean error in angle was 2.25 ± 1.41 degrees (range 0.30 to 5.00 degrees; 95% CI: 1.38 to 3.12 degrees) in the fully digital group and 2.10 ± 1.18 degrees (range 0.30 to 5.80 degrees; 95% CI: 1.37 to 2.83 degrees) in the conventional group. The difference was not statistically significant (-0.15 ± 1.63 degrees; range -3.20 to 2.90 degrees; 95% CI: -0.87 to 0.57 degrees; P = 0.668); in the horizontal plane (mesio-distal), the mean error was 0.52 ± 0.30 mm (range 0.10 to 1.10 mm; 95% CI: 0.33 to 0.70 mm) in the fully digital group and 0.44 ± 0.26 mm (range 0.10 to 0.90 mm; 95% CI: 0.27 to 0.60 mm) in the conventional group. The difference was not statistically significant (-0.08 ± 0.38 degrees; range -1.0 to 0.60 degrees; 95% CI: -0.32 to 0.16 degrees; P = 0.279); in the vertical plane (apico-coronal), the mean error was 0.58 ± 0.44 mm (range 0.00 to 1.60 mm; 95% CI: 0.31 to 0.85) in the fully digital group and 0.46 ± 0.34 mm (range 0.00 to 1.20 mm; 95% CI: 0.25 to 0.67) in the conventional group. The difference was not statistically significant (-0.12 ± 0.59 degrees; range -1.20 to 1.00 degrees; 95% CI: -0.49 to 0.24 degrees; P = 0.250). One year after loading, the mean marginal bone loss was 0.14 ± 0.12 mm (range -0.10 to 0.40 mm; 95% CI: 0.07 to 0.21 mm) in the fully digital group and 0.18 ± 0.13 mm (range -0.10 to 0.60 mm; 95% CI: 0.09 to 0.26 mm). The difference was not statistically significant (-0.04 ± 0.19 mm; range -0.50 to 0.30 mm; 95% CI: -0.16 to 0.08 mm; P = 0.294).
CONCLUSIONS


With the limitations of the present trial, implant rehabilitations planned using intraoral digital impressions showed similar results compared to conventional impression and scan model. Digital impression may be a viable option for the rehabilitation of partial edentulous patients when computer-guided template-assisted implant placement is used.",2019,Digital impression may be a viable option for the rehabilitation of partial edentulous patients when computer-guided template-assisted implant placement is used.,"['partially edentulous patients with at least five residual teeth, requiring at least one implant to be planned on three-dimensional (3D) cone beam computed tomography (CBCT) scan according to a computer-assisted template-based protocol were enrolled', 'partial edentulous patients', 'Twenty patients (11 females and 9 males; mean age 44.6 years old', 'to rehabilitate partially edentulous patients']","['computer-assisted template-based implant placement using conventional impression and scan model or intraoral digital impression', 'intraoral digital impression (fully digital group) or conventional impression and scan model (conventional group', 'computer-assisted template-based implant placement using conventional impression and scan of a physical stone cast or intraoral scanning']","['mean marginal bone loss', 'mean error in angle', 'biological or mechanical complications', 'implant and prosthetic success, complications, accuracy and peri-implant marginal bone loss']","[{'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C1956110', 'cui_str': 'Cone-Beam Computerized Tomography'}, {'cui': 'C0441633'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0441633'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}]",10.0,0.104959,Digital impression may be a viable option for the rehabilitation of partial edentulous patients when computer-guided template-assisted implant placement is used.,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tallarico', 'Affiliation': ''}, {'ForeName': 'Erta', 'Initials': 'E', 'LastName': 'Xhanari', 'Affiliation': ''}, {'ForeName': 'Yong-Jin', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Cocchi', 'Affiliation': ''}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Martinolli', 'Affiliation': ''}, {'ForeName': 'Adem', 'Initials': 'A', 'LastName': 'Alushi', 'Affiliation': ''}, {'ForeName': 'Edoardo', 'Initials': 'EE', 'LastName': 'Baldoni', 'Affiliation': ''}, {'ForeName': 'Silvio Mario', 'Initials': 'SM', 'LastName': 'Meloni', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1528,31090751,Minimally invasive flap compared to a trapezoidal flap in lateral approach maxillary sinus elevation procedures: Four-month post-loading results from a split-mouth randomised controlled trial.,"PURPOSE


To test a minimally invasive flap in the lateral approach for maxillary sinus floor elevation when compared to a trapezoidal flap.
MATERIALS AND METHODS


Each patient received a bilateral sinus elevation procedure based on two different randomly allocated surgical approaches according to a split-mouth design: in the test side, a horizontal incision at mucogingival line was realised; in the control side, a trapezoidal flap was elevated to prepare the lateral window. Each sinus was filled using deproteinised bovine bone and the window covered with a collagen membrane. Implants were inserted according to a two-stage technique 6 months after sinus elevation procedures, submerged and then loaded after 6 months with definitive screw-retained metal-ceramic prostheses. Patients were followed up to 4 months post-loading. Outcome measures included: implant and prosthesis failures, complications, peri-implant marginal bone level changes, residual bone height and width, recorded before sinus augmentation and 180 days post-intervention by computed tomography (CT) scans, surgical times and patient discomfort data, assessed using a visual analogue scale (VAS) diagram for each treated side at 1, 7, 14 and 30 days of follow-up.
RESULTS


Seventeen patients were enrolled in this trial and none dropped out. Five completely edentulous patients were treated with full-arch prosthetic restorations (Toronto dental prosthesis) and 12 patients with partial metal-ceramic screw-retained prostheses. In total 72 implants were inserted, 37 in the test group and 35 in the control group. No prosthesis or implant failures occurred. A total of seven patients showed complications: five of them had complications in both test and control sides. Eight complications were detected in each group. During maxillary sinus elevation procedures, nine interventions (four from the test group and five from the control group) were affected by intrasurgical complications (six membrane perforations and three severe bleedings); post-surgical complications occurred to three patients (one submucosal emphysema in a patient from the test group, one wound dehiscence and a graft infection both recorded in the control group); a total of four implants in two patients in the test group, versus three implants from one patient in the control group showed peri-implant mucositis. There were no statistically significant differences in complications between the two groups (P = 1.00; 95% confidence interval [CI]: 0.15-3.11). Patients from the control group, at 4 months after loading, lost on average 0.53 mm (standard deviation [SD] 0.27; 95% CI: 0.40-0.65), and patients from the test group lost on average 0.66 mm (SD 0.27; 95% CI: 0.53-0.78); the difference was not statistically significant (mean difference: 0.07 mm; SD 0.34; 95% CI: -0.03-0.17; P = 0.102). Significant values for bone augmentation in height, 9.26 mm (SD 1.46; 95% CI: 8.56-9.95) in the test group and 9.38 mm (SD 1.95; 95% CI: 8.45-10.30) in the control group, and width, 1.68 mm (SD 1.04; 95% CI: 1.18-2.20) in the test group and 1.60 mm (SD 1.27; 95% CI: 0.99-2.20) in the control group, were found from the 180-day CT scans. No statistically significant differences were detected between the two groups, either for the bone augmentation data (difference: 0.27 mm; 95% CI: 0.15-0.38; P = 0.60) or for the bone width values (difference: 0.02 mm; 95% CI: 0.07-0.11; P = 0.67). A significant reduction in the total surgical time was found in the test group (mean difference: 6.64 minutes; SD 4.32; 95% CI: 4.58-8.69), with the difference being statistically significant (P = 0.009). Evaluation of patients' postoperative discomfort showed a significant preference for the test procedure: at 1 day the VAS value was 4 (interquartile range [IQR] 2 to 5) in the test group; in the control group the VAS score was 5 (IQR 4 to 8). The intergroup difference was statistically significant (P = 0.002). At the 7-day follow-up, the VAS value was 1 in the test group (IQR 0 to 3) and 3 in the control group (IQR 0 to 7), this difference was statistically significant (P = 0.003). No differences were detected at 14 and 30 days (P > 0.05).
CONCLUSIONS


A minimally invasive approach to access the sinus cavity can be as successful as a conventional trapezoidal flap in maxillary sinus floor elevations.",2019,A minimally invasive approach to access the sinus cavity can be as successful as a conventional trapezoidal flap in maxillary sinus floor elevations.,['Seventeen patients'],"['Minimally invasive flap', 'trapezoidal flap', 'partial metal-ceramic screw-retained prostheses', 'full-arch prosthetic restorations (Toronto dental prosthesis', 'minimally invasive flap', 'bilateral sinus elevation procedure']","['bone width values', 'VAS value', 'bone augmentation data', 'VAS score', 'peri-implant mucositis', 'intrasurgical complications (six membrane perforations and three severe bleedings); post-surgical complications', 'total surgical time', 'wound dehiscence and a graft infection', 'implant and prosthesis failures, complications, peri-implant marginal bone level changes, residual bone height and width, recorded before sinus augmentation and 180 days post-intervention by computed tomography (CT) scans, surgical times and patient discomfort data, assessed using a visual analogue scale (VAS) diagram', 'complications']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0162686', 'cui_str': 'Dental Prosthesis'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3698407', 'cui_str': 'Dental peri-implant mucositis (disorder)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence (morphologic abnormality)'}, {'cui': 'C0349725', 'cui_str': 'Graft infection (disorder)'}, {'cui': 'C0524929', 'cui_str': 'Prosthetic Implants'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2236586', 'cui_str': 'Sinus graft'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",5.0,0.184253,A minimally invasive approach to access the sinus cavity can be as successful as a conventional trapezoidal flap in maxillary sinus floor elevations.,"[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Baldini', 'Affiliation': ''}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': ""D'Elia"", 'Affiliation': ''}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Mirra', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ferrari', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1529,31062373,Influence of Calcineurin Inhibitor and Sex on Mycophenolic Acid Pharmacokinetics and Adverse Effects Post-Renal Transplant.,"Tacrolimus or cyclosporine is prescribed with mycophenolic acid posttransplant and contributes to interpatient variability in mycophenolic acid pharmacokinetics and response. Cyclosporine inhibits enterohepatic circulation of the metabolite mycophenolic acid glucuronide, which is not described with tacrolimus. This study investigated mycophenolic acid pharmacokinetics and adverse effects in stable renal transplant recipients and the association with calcineurin inhibitors, sex, and race. Mycophenolic acid and mycophenolic acid glucuronide area under the concentration-time curve from 0 to 12 hours (AUC 0-12h  ) and apparent clearance were determined at steady state in 80 patients receiving cyclosporine with mycophenolate mofetil and 67 patients receiving tacrolimus with mycophenolate sodium. Gastrointestinal adverse effects and hematologic parameters were evaluated. Statistical models evaluated mycophenolic acid pharmacokinetics and adverse effects. Mycophenolic acid AUC 0-12h  was 1.70-fold greater with tacrolimus (68.9 ± 30.9 mg·h/L) relative to cyclosporine (40.8 ± 17.6 mg·h/L); P < .001. Target mycophenolic acid AUC 0-12h  of 30-60 mg·h/L was achieved in 56.3% on cyclosporine compared with 34.3% receiving tacrolimus (P < .001). Mycophenolic acid clearance was 48% slower with tacrolimus (10.6 ± 4.7 L/h) relative to cyclosporine (20.5 ± 10.0 L/h); P < .001. Enterohepatic circulation occurred less frequently with cyclosporine (45%) compared with tacrolimus (78%); P < 0.001; with a 2.9-fold greater mycophenolic acid glucuronide AUC 0-12h  to mycophenolic acid AUC 0-12h  ratio (P < .001). Race did not affect mycophenolic acid pharmacokinetics. Gastrointestinal adverse effect scores were 2.2-fold higher with tacrolimus (P < .001) and more prominent in women (P = .017). Lymphopenia was more prevalent with tacrolimus (52.2%) than cyclosporine (22.5%); P < 0.001. Calcineurin inhibitors and sex contributed to interpatient variability in mycophenolic acid pharmacokinetics and adverse effects post-renal transplant, which could be attributed to differences in enterohepatic circulation.",2019,Enterohepatic circulation occurred less frequently with cyclosporine (45%) compared with tacrolimus (78%); P < 0.001; with a 2.9-fold greater mycophenolic acid glucuronide AUC 0-12h  to mycophenolic acid AUC 0-12h  ratio (P ,"['stable renal transplant recipients', '80 patients receiving', '17.6']","['tacrolimus with mycophenolate sodium', 'Calcineurin Inhibitor', 'cyclosporine', 'Calcineurin inhibitors', 'tacrolimus', 'cyclosporine with mycophenolate mofetil', 'Mycophenolic acid and mycophenolic acid glucuronide', 'mycophenolic acid pharmacokinetics', 'Tacrolimus or cyclosporine', 'Mycophenolic acid AUC', 'Cyclosporine']","['Lymphopenia', 'Gastrointestinal adverse effects and hematologic parameters', 'mycophenolic acid pharmacokinetics and adverse effects', 'Mycophenolic acid clearance', 'Enterohepatic circulation', 'mycophenolic acid pharmacokinetics', 'Target mycophenolic acid AUC', 'Gastrointestinal adverse effect scores', 'mycophenolic acid glucuronide AUC']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C1337395', 'cui_str': 'mycophenolate sodium'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0676811', 'cui_str': 'mycophenolic acid 7-O-glucuronide'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]","[{'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0014362', 'cui_str': 'Entero-Hepatic Circulation'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0676811', 'cui_str': 'mycophenolic acid 7-O-glucuronide'}]",80.0,0.0689333,Enterohepatic circulation occurred less frequently with cyclosporine (45%) compared with tacrolimus (78%); P < 0.001; with a 2.9-fold greater mycophenolic acid glucuronide AUC 0-12h  to mycophenolic acid AUC 0-12h  ratio (P ,"[{'ForeName': 'Calvin J', 'Initials': 'CJ', 'LastName': 'Meaney', 'Affiliation': 'Immunosuppressive Pharmacology Research Program, Translational Pharmacology Research Core, Buffalo, NY, USA.'}, {'ForeName': 'Patcharaporn', 'Initials': 'P', 'LastName': 'Sudchada', 'Affiliation': 'Immunosuppressive Pharmacology Research Program, Translational Pharmacology Research Core, Buffalo, NY, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Consiglio', 'Affiliation': 'Department of Biostatistics, School of Public Health and Health Professions, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Wilding', 'Affiliation': 'Department of Biostatistics, School of Public Health and Health Professions, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Cooper', 'Affiliation': 'Immunosuppressive Pharmacology Research Program, Translational Pharmacology Research Core, Buffalo, NY, USA.'}, {'ForeName': 'Rocco C', 'Initials': 'RC', 'LastName': 'Venuto', 'Affiliation': 'Department of Medicine; Nephrology Division, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Tornatore', 'Affiliation': 'Immunosuppressive Pharmacology Research Program, Translational Pharmacology Research Core, Buffalo, NY, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1428']
1530,31551154,Cytokines hold promise for human embryo culture in vitro: results of a randomized clinical trial.,"OBJECTIVE


To evaluate the effects of cytokine enrichment of culture medium on embryological and clinical outcomes after intracytoplasmic sperm injection (ICSI).
DESIGN


A randomized clinical trial.
SETTING


In vitro fertilization centers.
PATIENT(S)


This trial included 443 ICSI cycles randomized into two groups.
INTERVENTION(S)


This study evaluated the influence of integration of granulocyte-macrophage colony-stimulating factor, heparin-binding epidermal growth factor-like growth factor, and leukemia inhibitory factor into culture media on human embryo development after ICSI.
MAIN OUTCOME MEASURE(S)


Ongoing pregnancy rate per a randomized participant.
RESULT(S)


Cytokine enrichment of culture medium showed improvement in ongoing pregnancy rate compared with no cytokines (106/224 [47%] vs. 78/219 [36%]; absolute rate difference [ARD] = 12; 95% confidence interval [CI], 2.5-21). This integration of cytokines also showed better rates of live birth (101/224 [45%] vs. 71/219 [33%]; ARD = 13; 95% CI, 4-21) and cumulative live birth (132/224 [60%] vs. 97/219 [44%]; ARD = 12; 95% CI, 4-20) and lower rate of pregnancy loss (27/124 [22%] vs. 37/103 [36%]; ARD = -14; 95% CI, -26 to -2) than conventional medium. Embryos developed in the cytokine-supplemented medium showed better blastocyst formation, quality, cryopreservation, and use than control medium.
CONCLUSION(S)


Integration of cytokines into human embryo culture media showed improvement in embryological and clinical outcomes after ICSI. However, the long-term effect of cytokine enrichment of a medium is still unclear and warrants further studies with longitudinal follow-up.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02420886 at ClinicalTrials.gov.",2019,"Cytokine enrichment of culture medium showed improvement in ongoing pregnancy rate compared with no cytokines (106/224 [47%] vs. 78/219 [36%]; absolute rate difference [ARD] = 12; 95% confidence interval [CI], 2.5-21).","['443 ICSI cycles randomized into two groups', 'human embryo culture in\xa0vitro']","['granulocyte-macrophage colony-stimulating factor, heparin', 'intracytoplasmic sperm injection (ICSI']","['blastocyst formation, quality, cryopreservation, and use than control medium', 'embryological and clinical outcomes', 'rates of live birth', 'rate of pregnancy loss', 'cumulative live birth', 'ongoing pregnancy rate']","[{'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}]","[{'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0010405', 'cui_str': 'Cryofixation'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",443.0,0.510737,"Cytokine enrichment of culture medium showed improvement in ongoing pregnancy rate compared with no cytokines (106/224 [47%] vs. 78/219 [36%]; absolute rate difference [ARD] = 12; 95% confidence interval [CI], 2.5-21).","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Fawzy', 'Affiliation': 'IbnSina IVF Center, IbnSina Hospital, Sohag, Egypt; Banon IVF Center, Assiut, Egypt. Electronic address: drfawzy001@me.com.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Emad', 'Affiliation': 'IbnSina IVF Center, IbnSina Hospital, Sohag, Egypt; Banon IVF Center, Assiut, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Elsuity', 'Affiliation': 'IbnSina IVF Center, IbnSina Hospital, Sohag, Egypt; Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mahran', 'Affiliation': 'Banon IVF Center, Assiut, Egypt; Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed Y', 'Initials': 'MY', 'LastName': 'Abdelrahman', 'Affiliation': 'Department of Obstetrics and Gynecology, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Ahmed N', 'Initials': 'AN', 'LastName': 'Fetih', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Abdelghafar', 'Affiliation': 'Department of Obstetrics and Gynecology, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sabry', 'Affiliation': 'Department of Obstetrics and Gynecology, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Nour', 'Affiliation': 'Department of Obstetrics and Gynecology, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Salah M', 'Initials': 'SM', 'LastName': 'Rasheed', 'Affiliation': 'Department of Obstetrics and Gynecology, Sohag University, Sohag, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.07.012']
1531,31713505,Randomized Comparison of Two Approaches to Initial Warfarin Dosing: Time in Therapeutic Range of International Normalized Ratio During Hospitalization.,"AIM


To perform a randomized, open-label comparison of average time in therapeutic range (TTR) of international normalized ratio (INR) using two approaches to initial warfarin dosing during hospitalization: the standard method and the one using individual patient characteristics (clinical algorithm - the studied approach).
MATERIALS AND METHODS


We randomly assigned 60 patients with different indications for vitamin K antagonist therapy to the studied approach (n=31, intervention group) or to the standard method (n=29, control group). А target INR range for all patients was 2.0 to 3.0.
RESULTS


The average TTR and portions of INR values within target range during the whole time of drug dosing turned out to be small. TTR was 22.4% with standard method and 21.4% with clinical algorithm, which was well below desired 60%.
CONCLUSION


The opportunities for achieving target INR in inpatient settings, regardless of warfarin dosing regimen, are limited.",2018,"TTR was 22.4% with standard method and 21.4% with clinical algorithm, which was well below desired 60%.
",['60 patients with different indications for'],['vitamin K antagonist therapy'],"['TTR', 'average TTR and portions of INR values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}]","[{'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0592546,"TTR was 22.4% with standard method and 21.4% with clinical algorithm, which was well below desired 60%.
","[{'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Mishchenko', 'Affiliation': 'ФГБОУ ВО «РНИМУ им. Н. И. Пирогова»; «ГКБ № 15 имени О. М. Филатова».'}, {'ForeName': 'Oleg V', 'Initials': 'OV', 'LastName': 'Averkov', 'Affiliation': '«ГКБ № 15 имени О. М. Филатова».'}, {'ForeName': 'I G', 'Initials': 'IG', 'LastName': 'Gordeev', 'Affiliation': 'ФГБОУ ВО «РНИМУ им. Н. И. Пирогова».'}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Levchuk', 'Affiliation': '«ГКБ № 15 имени О. М. Филатова».'}, {'ForeName': 'V I', 'Initials': 'VI', 'LastName': 'Vechorko', 'Affiliation': '«ГКБ № 15 имени О. М. Филатова».'}]",Kardiologiia,['10.18087/cardio.2017.9.10030']
1532,31047902,Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial.,"BACKGROUND


Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard) in hypoglycaemia-prone adults with type 1 diabetes.
METHODS


SMILE was an open-label randomised controlled trial done in people aged 24-75 years with type 1 diabetes for 10 years or longer, HbA 1c  values of 5·8-10·0% (40-86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4). Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK. After baseline run-in phase (2 weeks), participants were randomly assigned to the MiniMed 640G pump (continuous subcutaneous insulin infusion) with self-monitoring of blood glucose (control group) or to the MiniMed 640G system with the suspend-before-low feature enabled (intervention group), for 6 months. The study statistician analysing the data was masked to group assignment until final database lock; because of the nature of the intervention, participants and treating clinicians could not be masked to group assignment. The primary outcome was the mean number of sensor hypoglycaemic events, defined as 55 mg/dL (3·1 mmol/L) or lower, and was analysed on an intention-to-treat basis in all randomly assigned participants. This trial is registered with ClinicalTrials.gov, number NCT02733991, and is completed.
FINDINGS


Between Dec 7, 2016, and March 27, 2018, 153 participants with a mean age 48·2 [12·4] years were randomly assigned: 77 to the control group (mean age 47·4 [12·5] years) and 76 to the intervention group (mean age 49·0 [12·2] years). After 6 months, the intervention group had significantly fewer hypoglycaemic events per participant per week (1·1 [SD 1·2] vs 4·1 [3·4] mean events, model-based treatment effect -2·9 [95% CI -3·5 to -2·3]; p<0·0001) and fewer severe hypoglycaemic events (instances requiring third-party assistance with carbohydrate or glucagon administration, or other resuscitative actions) overall (three vs 18; p=0·0036). The most common adverse events were hypoglycaemia (observed in ten [13%] of 77 participants in the control group vs four [5%] of 76 in the intervention group) and hyperglycaemia (observed in seven [9%] of 77 vs seven [9%] of 76). No serious adverse device effects or episodes of diabetic ketoacidosis were reported.
INTERPRETATION


Insulin pump therapy with integrated CGM and a suspend-before-low feature reduced the frequency of sensor hypoglycaemic and severe hypoglycaemic events in hypoglycaemia-prone adults compared with use of continuous subcutaneous insulin infusion without real-time CGM. These results suggest that this technology could be beneficial in this high-risk population.
FUNDING


Medtronic International Trading Sàrl and Medtronic Canada.",2019,The most common adverse events were hypoglycaemia (observed in ten [13%] of 77 participants in the control group vs four [5%] of 76 in the intervention group) and hyperglycaemia (observed in seven [9%] of 77 vs seven [9%] of 76).,"['hypoglycaemia-prone adults with type 1 diabetes', 'Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK', '12·5] years) and 76 to the intervention group (mean age 49·0', 'Between Dec 7, 2016, and March 27, 2018', '153 participants with a mean age 48·2 [12·4] years were randomly assigned: 77 to the control group (mean age 47·4', 'people aged 24-75 years with type 1 diabetes for 10 years or longer, HbA 1c  values of 5·8-10·0% (40-86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4', 'hypoglycaemia-prone adults with type 1 diabetes (SMILE', 'hypoglycaemia-prone adults']","['insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard', 'MiniMed 640G pump (continuous subcutaneous insulin infusion) with self-monitoring of blood glucose (control group) or to the MiniMed 640G system with the suspend-before-low feature enabled (intervention group', 'suspend-before-low insulin pump technology']","['safety and efficacy', 'hypoglycaemic events', 'hypoglycaemia', 'hyperglycaemia', 'Efficacy and safety', 'severe hypoglycaemic events (instances requiring third-party assistance with carbohydrate or glucagon administration, or other resuscitative actions) overall', 'mean number of sensor hypoglycaemic events', 'serious adverse device effects or episodes of diabetic ketoacidosis']","[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0342317', 'cui_str': 'Loss of hypoglycemic warning (disorder)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}]","[{'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C1705537', 'cui_str': 'Suspended'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0005803', 'cui_str': 'Monitoring, Home Blood Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}]",153.0,0.179194,The most common adverse events were hypoglycaemia (observed in ten [13%] of 77 participants in the control group vs four [5%] of 76 in the intervention group) and hyperglycaemia (observed in seven [9%] of 77 vs seven [9%] of 76).,"[{'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Bosi', 'Affiliation': 'Diabetes Research Institute, IRCCS San Raffaele Hospital and San Raffaele Vita Salute University, Milan, Italy.'}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Choudhary', 'Affiliation': ""Department of Internal Medicine, King's College Hospital, Diabetes Research Group, Weston Education Center, London, UK.""}, {'ForeName': 'Harold W', 'Initials': 'HW', 'LastName': 'de Valk', 'Affiliation': 'Department of Internal Medicine, University Medical Center, Utrecht, Netherlands.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lablanche', 'Affiliation': ""Department of Diabetology, Grenoble University Hospital, Service d'Endocrinologie, Pôle Digidune, Grenoble, France.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Castañeda', 'Affiliation': 'Bakken Research Centre, Maastricht, Netherlands.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'de Portu', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Da Silva', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'Roseline', 'Initials': 'R', 'LastName': 'Ré', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Vorrink-de Groot', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Medtronic, Northridge, CA, USA.'}, {'ForeName': 'Francine R', 'Initials': 'FR', 'LastName': 'Kaufman', 'Affiliation': 'Medtronic, Northridge, CA, USA.'}, {'ForeName': 'Ohad', 'Initials': 'O', 'LastName': 'Cohen', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland. Electronic address: ohad.cohen@medtronic.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30150-0']
1533,31727361,Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy.,"PURPOSE


The goal of this study was to compare the lipid-lowering efficacy of the combination of ezetimibe and low- or intermediate-intensity statin therapy versus that of high-intensity statin monotherapy.
METHODS


This study is a post hoc analysis of an 8-week, randomized, double-blind, Phase III trial. Patients who had hypercholesterolemia and required lipid-lowering treatment were randomly assigned to 1 of 6 treatment groups: rosuvastatin 5 mg (R5, n = 68), rosuvastatin 10 mg (R10, n = 67), rosuvastatin 20 mg (R20, n = 69), and ezetimibe 10 mg combined with rosuvastatin 5 mg (R5 + E10, n = 67), rosuvastatin 10 mg (R10 + E10, n = 68), and rosuvastatin 20 mg (R20 + E10, n = 68) daily. The effects of coadministration of ezetimibe and a low dose of rosuvastatin on lipid parameters and the target achievement rate were compared between the R5 + E10 and R10 treatment groups, the R5 + E10 and R20 treatment groups, and the R10 + E10 and R20 treatment groups.
FINDINGS


Reductions in total cholesterol, LDL-C, apolipoprotein B, the apolipoprotein B/A1 ratio, and non-HDL-C were not different between the R5 + E10 and R10 treatment groups (all, P > 0.017), the R5 + E10 and R20 treatment groups (all, P > 0.017), and the R10 + E10 and R20 treatment groups (all, P > 0.017). R5 + E10 treatment showed efficacy comparable to that of R10 or R20 in affording LDL levels <50% of the baseline level (R5 + E10 vs R10, 73.13% vs 62.69% [P = 0.1952]; R5 + E10 vs R20, 73.13% vs 73.91% [P = 0.9180]), LDL-C levels <70 mg/dL (R5 + E10 vs R10, 64.18% vs 55.22% [P = 0.2906]; R5 + E10 vs R20, 64.18% vs 62.32% [P = 0.8220]), and LDL-C levels <50% of the baseline level or <70 mg/dL (R5 + E10 vs R10, 77.61% vs 70.15% [P = 0.3255]; R5 + E10 vs R20, 77.61% vs 78.26% [P = 0.9273]). The R10 + E10 treatment group was better than the R20 treatment group in achieving the target LDL-C level <70 mg/dL (83.82% vs 62.32%; P = 0.0046), even among participants with a baseline LDL-C level >135 mg/dL (77.5% vs 48.8%, respectively; P = 0.0074).
IMPLICATIONS


Ezetimibe combined with low- or intermediate-intensity statin therapy has lipid-lowering efficacy comparable to or better than that of high-intensity rosuvastatin monotherapy. The results of the present study indicate that the combination treatment with ezetimibe is advantageous in that it permits dose reduction of rosuvastatin without compromising the lipid-lowering efficacy of rosuvastatin. ClinicalTrials.gov identifier: NCT02205606.",2019,"FINDINGS


Reductions in total cholesterol, LDL-C, apolipoprotein B, the apolipoprotein B/A1 ratio, and non-HDL-C were not different between the R5 + E10 and R10 treatment groups (all, P > 0.017), the R5 + E10 and R20 treatment groups (all, P > 0.017), and the R10 + E10 and R20 treatment groups (all, P > 0.017).",['Patients who had hypercholesterolemia and required lipid-lowering treatment'],"['rosuvastatin 5\xa0mg (R5, n\xa0=\xa068), rosuvastatin 10\xa0mg (R10, n\xa0=\xa067), rosuvastatin 20\xa0mg (R20, n\xa0=\xa069), and ezetimibe 10\xa0mg combined with rosuvastatin 5\xa0mg (R5\xa0+\xa0E10, n\xa0=\xa067), rosuvastatin 10\xa0mg (R10\xa0+\xa0E10, n\xa0=\xa068), and rosuvastatin 20\xa0mg (R20\xa0+\xa0E10, n\xa0=\xa068) daily', 'ezetimibe and low- or intermediate-intensity statin therapy', 'Ezetimibe combined with low- or intermediate-intensity statin therapy', 'rosuvastatin', 'ezetimibe', 'Ezetimibe and Rosuvastatin']","['LDL levels', 'total cholesterol, LDL-C, apolipoprotein B, the apolipoprotein B/A1 ratio, and non-HDL-C', 'LDL-C levels', 'lipid parameters and the target achievement rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1593702', 'cui_str': 'ezetimibe 10 MG [Zetia]'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0368695', 'cui_str': 'Apolipoprotein B/A1 (substance)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",,0.0273947,"FINDINGS


Reductions in total cholesterol, LDL-C, apolipoprotein B, the apolipoprotein B/A1 ratio, and non-HDL-C were not different between the R5 + E10 and R10 treatment groups (all, P > 0.017), the R5 + E10 and R20 treatment groups (all, P > 0.017), and the R10 + E10 and R20 treatment groups (all, P > 0.017).","[{'ForeName': 'Moo-Yong', 'Initials': 'MY', 'LastName': 'Rhee', 'Affiliation': 'Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Kyung-Jin', 'Initials': 'KJ', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Ewha Womans University Medical Center, Ewha Womans University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Won', 'Initials': 'YW', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Woon', 'Initials': 'SW', 'LastName': 'Rha', 'Affiliation': 'Department of Internal Medicine, Medical College, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Cardiovascular Center, Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Choong-Hwan', 'Initials': 'CH', 'LastName': 'Kwak', 'Affiliation': 'Division of Cardiology, Department of Cardiovascular Center, Gyeongsang National University Hospital, Jinju, Republic of Korea.'}, {'ForeName': 'Weon', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Cardiovascular Department of Internal Medicine, Kyung Hee University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Chang-Wook', 'Initials': 'CW', 'LastName': 'Nam', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Keimyung University, Daegu, Republic of Korea.'}, {'ForeName': 'Tae-Ho', 'Initials': 'TH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Cardiology Division, Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Taek-Jong', 'Initials': 'TJ', 'LastName': 'Hong', 'Affiliation': 'Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Sungha', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Youngkeun', 'Initials': 'Y', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Namho', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hui-Kyung', 'Initials': 'HK', 'LastName': 'Jeon', 'Affiliation': ""Department of Cardiovascular, Uijeongbu, Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Dong Woon', 'Initials': 'DW', 'LastName': 'Jeon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Kyoo-Rok', 'Initials': 'KR', 'LastName': 'Han', 'Affiliation': 'Kangdong Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Republic of Korea.'}, {'ForeName': 'Keon-Woong', 'Initials': 'KW', 'LastName': 'Moon', 'Affiliation': ""Cardiology Division, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Republic of Korea.""}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Chae', 'Affiliation': 'Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Hae-Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Health Policy and Management, College of Health Science & Department of Public Health Science, Graduate School, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: hyosoo@snu.ac.kr.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.10.010']
1534,31072507,"A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study.","OBJECTIVES


The aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California) in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE).
BACKGROUND


Catheter-directed thrombolysis has been shown to improve right ventricular (RV) function in patients with PE. However, catheter-directed thrombolysis increases bleeding risk and many patients with PE have relative and absolute contraindications to thrombolysis.
METHODS


Patients with symptomatic, computed tomography-documented PE and RV/left ventricular (LV) ratios ≥0.9 were eligible for enrollment. The primary effectiveness endpoint was core laboratory-assessed change in RV/LV ratio. The primary safety endpoint comprised device-related death, major bleeding, treatment-related clinical deterioration, pulmonary vascular injury, or cardiac injury within 48 h of thrombectomy.
RESULTS


From April 2016 to October 2017, 106 patients were treated with the FlowTriever System at 18 U.S. sites. Two patients (1.9%) received adjunctive thrombolytics and were analyzed separately. Mean procedural time was 94 min; mean intensive care unit stay was 1.5 days. Forty-three patients (41.3%) did not require any intensive care unit stay. At 48 h post-procedure, average RV/LV ratio reduction was 0.38 (25.1%; p < 0.0001). Four patients (3.8%) experienced 6 major adverse events, with 1 patient (1.0%) experiencing major bleeding. One patient (1.0%) died, of undiagnosed breast cancer, through 30-day follow-up.
CONCLUSIONS


Percutaneous mechanical thrombectomy with the FlowTriever System appears safe and effective in patients with acute intermediate-risk PE, with significant improvement in RV/LV ratio and minimal major bleeding. Potential advantages include immediate thrombus removal, absence of thrombolytic complications, and reduced need for post-procedural critical care.",2019,"CONCLUSIONS


Percutaneous mechanical thrombectomy with the FlowTriever System appears safe and effective in patients with acute intermediate-risk PE, with significant improvement in RV/LV ratio and minimal major bleeding.","['patients with acute intermediate-risk pulmonary\xa0embolism (PE', '106 patients were treated with the FlowTriever System at 18 U.S. sites', 'Intermediate-Risk Acute Pulmonary Embolism', 'From April 2016 to October 2017', 'patients with acute intermediate-risk PE', 'patients with PE', 'Patients with symptomatic, computed tomography-documented PE and RV/left ventricular (LV) ratios', 'Forty-three patients (41.3%) did not require any intensive care unit stay']","['percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California', 'Catheter-Directed Mechanical Thrombectomy', 'catheter-directed thrombolysis']","['6\xa0major adverse events', 'Mean procedural time', 'average RV/LV ratio reduction', 'right ventricular (RV) function', 'core laboratory-assessed change in RV/LV ratio', 'safety and effectiveness', 'RV/LV ratio and minimal major bleeding', 'experiencing major bleeding', 'device-related death, major bleeding, treatment-related clinical deterioration, pulmonary vascular injury, or cardiac injury within 48 h of thrombectomy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C4517770', 'cui_str': '41.3'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0080311', 'cui_str': 'Ventricular Function, Right'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4505323', 'cui_str': 'Clinical Deterioration'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0178324', 'cui_str': 'Vascular Injuries'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}]",106.0,0.0314916,"CONCLUSIONS


Percutaneous mechanical thrombectomy with the FlowTriever System appears safe and effective in patients with acute intermediate-risk PE, with significant improvement in RV/LV ratio and minimal major bleeding.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tu', 'Affiliation': 'Baptist Health Louisville, Louisville, Kentucky. Electronic address: ttu@bellsouth.net.'}, {'ForeName': 'Catalin', 'Initials': 'C', 'LastName': 'Toma', 'Affiliation': 'University of Pittsburgh Medical Center Heart and Vascular Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Victor F', 'Initials': 'VF', 'LastName': 'Tapson', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Adams', 'Affiliation': 'CAMC Memorial Hospital, Charleston, West Virginia.'}, {'ForeName': 'Wissam A', 'Initials': 'WA', 'LastName': 'Jaber', 'Affiliation': 'Emory University Hospital, Atlanta, Georgia.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Silver', 'Affiliation': 'OhioHealth Heart and Vascular Physicians, Columbus, Ohio.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Khandhar', 'Affiliation': 'Penn Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Amin', 'Affiliation': 'Sacred Heart Hospital Pensacola, Pensacola, Florida.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Weinberg', 'Affiliation': 'North Shore University Hospital, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Tod', 'Initials': 'T', 'LastName': 'Engelhardt', 'Affiliation': 'East Jefferson General Hospital, Metairie, Louisiana.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Hunter', 'Affiliation': ""St. Vincent's Birmingham, Birmingham, Alabama.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Holmes', 'Affiliation': 'East Alabama Medical Center, Opelika, Alabama.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Hoots', 'Affiliation': 'Tampa General Hospital, Tampa, Florida.'}, {'ForeName': 'Hussam', 'Initials': 'H', 'LastName': 'Hamdalla', 'Affiliation': 'Ephraim McDowell Regional Medical Center, Danville, Kentucky.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Maholic', 'Affiliation': 'University of Pittsburgh Medical Center Hamot, Erie, Pennsylvania.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Lilly', 'Affiliation': 'The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ouriel', 'Affiliation': 'Syntactx, New York, New York.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Rosenfield', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2018.12.022']
1535,31733647,Differences in lipid metabolism between anagliptin and sitagliptin in patients with type 2 diabetes on statin therapy: a secondary analysis of the REASON trial.,"BACKGROUND


Anagliptin, a dipeptidyl peptidase-4 inhibitor, is reported to reduce the level of low-density lipoprotein cholesterol (LDL-C). The underlying mechanism of this effect and effect on lipid metabolism however remains uncertain.
AIM AND METHODS


We therefore evaluate the effects of anagliptin on lipid metabolism-related markers compared with those of sitagliptin. The study was a secondary analysis using data obtained from the Randomized Evaluation of Anagliptin versus Sitagliptin On low-density lipoproteiN cholesterol in diabetes (REASON) trial. This trial in patients with type 2 diabetes at a high risk of cardiovascular events and on statin therapy showed that anagliptin reduced LDL-C levels to a greater extent than sitagliptin. Cholesterol absorption (campesterol and sitosterol) and synthesis (lathosterol) markers were measured at baseline and 52 weeks in the study cohort (n = 353).
RESULTS


There was no significant difference in the changes of campesterol or sitosterol between the two treatment groups (p = 0.85 and 0.55, respectively). Lathosterol concentration was increased significantly at 52 weeks with sitagliptin treatment (baseline, 1.2 ± 0.7 μg/mL vs. 52 weeks, 1.4 ± 1.0 μg/mL, p = 0.02), whereas it did not change in the anagliptin group (baseline, 1.3 ± 0.8 μg/mL vs. 52 weeks, 1.3 ± 0.7 μg/mL, p = 0.99). The difference in absolute change between the two groups showed a borderline significance (p = 0.06).
CONCLUSION


These findings suggest that anagliptin reduces LDL-C level by suppressing excess cholesterol synthesis, even in combination with statin therapy. Trial registration ClinicalTrials.gov number NCT02330406. https://clinicaltrials.gov/ct2/show/NCT02330406; registered January 5, 2015.",2019,"There was no significant difference in the changes of campesterol or sitosterol between the two treatment groups (p = 0.85 and 0.55, respectively).","['patients with type 2 diabetes at a high risk of cardiovascular events and on statin therapy showed that anagliptin reduced LDL-C levels to a greater extent than sitagliptin', 'patients with type 2 diabetes on statin therapy']","['anagliptin', 'Anagliptin versus Sitagliptin']","['changes of campesterol or sitosterol', 'Cholesterol absorption (campesterol and sitosterol) and synthesis (lathosterol) markers', 'Lathosterol concentration', 'lipid metabolism-related markers', 'LDL-C level', 'lipid metabolism']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C3272640', 'cui_str': 'Pyrazolo(1,5-a)pyrimidine-6-carboxamide, N-(2-((2-((2S)-2-cyano-1-pyrrolidinyl)-2-oxoethyl)amino)-2-methylpropyl)-2-methyl-'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C3272640', 'cui_str': 'Pyrazolo(1,5-a)pyrimidine-6-carboxamide, N-(2-((2-((2S)-2-cyano-1-pyrrolidinyl)-2-oxoethyl)amino)-2-methylpropyl)-2-methyl-'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0054560', 'cui_str': 'campesterol'}, {'cui': 'C0220914', 'cui_str': 'gamma-sitosterol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0064673', 'cui_str': 'cholest-7-en-3-ol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.575522,"There was no significant difference in the changes of campesterol or sitosterol between the two treatment groups (p = 0.85 and 0.55, respectively).","[{'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Chihara', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, 5-1-1 Nabeshima, Saga, 849-8501, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, 5-1-1 Nabeshima, Saga, 849-8501, Japan. tanakaa2@cc.saga-u.ac.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Shimabukuro', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nomiyama', 'Affiliation': 'Department of Endocrinology and Diabetes Mellitus, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Arasaki', 'Affiliation': 'Department of Cardiology, Tomishiro Central Hospital, Tomigusuku, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of the Ryukyus, Nishihara, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, 5-1-1 Nabeshima, Saga, 849-8501, Japan.'}]",Cardiovascular diabetology,['10.1186/s12933-019-0965-3']
1536,31027929,Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against all respiratory tract infections in children under two years of age.,"BACKGROUND


Pneumococcal conjugate vaccines reduce the incidence of invasive pneumococcal diseases, pneumonia, acute otitis media (AOM), and antimicrobial prescriptions in children. We investigated the effectiveness of at least one dose of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GSK) against respiratory tract infections (RTIs) in children under two years of age.
METHODS


424 children enrolled in a cluster-randomized, double-blind Finnish Invasive Pneumococcal disease (FinIP) vaccine trial during the years 2009-2010 were actively followed in a prospective cohort study (STEPS study) for RTIs from birth to two years of age. Children received the PHiD-CV10 vaccine, or a control vaccine (hepatitis A or B vaccine) according to an age-specific schedule. Data on RTIs were collected by symptom diaries, clinic visits, an electronic registry on hospitalizations, and by nasal swab samples analyzed for respiratory viruses. We estimated the vaccine effectiveness against all RTI episodes and RTI episodes with or without AOM by comparing the corresponding incidence rates between PHiD-CV10 vaccinated and control children, adjusted for presence of siblings and cluster as a random effect.
RESULTS


A total of 3193 RTI episodes were documented after the first vaccination in 368 children with all data available. The majority of the illnesses were upper RTIs caused by rhinovirus. The PHiD-CV10-vaccinated children had lower mean annual rates of all RTI episodes (6.4; 95% confidence interval [CI], 6.0-6.8) and RTI episodes with AOM (1.0; 95% CI, 0.9-1.2) as compared to the control children (7.4; 95% CI, 6.8-8.0 and 1.3; 95% CI, 1.1-1.6, respectively). The vaccine effectiveness was 12% (95% CI, 2-22%) against all RTIs, 23% (95% CI, 0-40%) against RTIs with AOM, and 10% (95% CI, 0-19%) against RTIs without AOM.
CONCLUSIONS


Vaccination with PHiD-CV10 resulted in lower rates of RTIs in children under two years of age compared to children vaccinated with control vaccine.",2019,"The vaccine effectiveness was 12% (95% CI, 2-22%) against all RTIs, 23% (95% CI, 0-40%) against RTIs with AOM, and 10% (95% CI, 0-19%) against RTIs without AOM.
","['children under two years of age', '424 children enrolled in a cluster-randomized, double-blind Finnish Invasive Pneumococcal disease (FinIP) vaccine trial during the years 2009-2010 were actively followed in a prospective cohort study (STEPS study) for RTIs from birth to two years of age', 'children', '368 children with all data available']","['PHiD-CV10', 'pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GSK', 'ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10', 'PHiD-CV10 vaccine, or a control vaccine (hepatitis A or B vaccine']","['mean annual rates of all RTI episodes', 'rates of RTIs', 'vaccine effectiveness', 'vaccine effectiveness against all RTI episodes and RTI episodes', 'RTI episodes with AOM']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1320214', 'cui_str': 'Invasive Streptococcus pneumoniae disease'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0450819', 'cui_str': 'CV10 (body structure)'}, {'cui': 'C0138826', 'cui_str': 'surface-exposed lipoprotein D, Haemophilus influenzae'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019159', 'cui_str': 'Hepatitis, Infectious'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]",424.0,0.304624,"The vaccine effectiveness was 12% (95% CI, 2-22%) against all RTIs, 23% (95% CI, 0-40%) against RTIs with AOM, and 10% (95% CI, 0-19%) against RTIs without AOM.
","[{'ForeName': 'Sinikka', 'Initials': 'S', 'LastName': 'Karppinen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Turku, Finland. Electronic address: simahe@utu.fi.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Toivonen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Schuez-Havupalo', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Teros-Jaakkola', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Waris', 'Affiliation': 'Department of Virology and Clinical Virology, University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Auranen', 'Affiliation': 'Department of Mathematics and Statistics, University of Turku, Turku, Finland; Department of Clinical Medicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Arto A', 'Initials': 'AA', 'LastName': 'Palmu', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, Tampere, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Peltola', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Turku, Finland.'}]",Vaccine,['10.1016/j.vaccine.2019.04.026']
1537,30838389,Evaluation of an education program based on the theory of planned behavior for salt intake in individuals at risk of hypertension.,"This study was conducted to evaluate an education program based on the theory of planned behavior (TPB) for salt intake in individuals at risk of hypertension. This randomized controlled trial was conducted from February 2017 to December 2017 in Shahediyeh, Yazd Province, Iran. For this purpose, 140 people were selected and assigned to two groups of 70 each, namely, intervention and control. Data were gathered by a self-administered TPB based questionnaire, and also 24-h urinary sodium and potassium levels and systolic and diastolic blood pressure were measured. The intervention group received TPB based on a training package, while the control group received no intervention. Post-test was administered 2 months after completion of the intervention. Independent and paired t-tests, χ2 and analysis of covariance (ANCOVA) were used for data analysis. All mean scores on TPB constructs increased significantly except motivation to comply and power of control for intervention group. Average salt intake decreased in intervention group compared with the control group (-4.73 g/day �0.73 versus -0.24 g/day �0.94, P < 0.001), but systolic and diastolic blood pressure did not change significantly in intervention group compared with control group. TPB can be implemented along with other approaches in educational programs to reduce salt intake. Code: IRCT201701108803N3.",2019,"Average salt intake decreased in intervention group compared with the control group (-4.73 g/day �0.73 versus -0.24 g/day �0.94, P < 0.001), but systolic and diastolic blood pressure did not change significantly in intervention group compared with control group.","['140 people', 'February 2017 to December 2017 in Shahediyeh, Yazd Province, Iran', 'individuals at risk of hypertension']","['education program', 'TPB', 'TPB based on a training package, while the control group received no intervention', 'education program based on the theory of planned behavior (TPB']","['24-h urinary sodium and potassium levels and systolic and diastolic blood pressure', 'Average salt intake', 'systolic and diastolic blood pressure']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0428289', 'cui_str': 'Finding of potassium level (finding)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]",140.0,0.0353549,"Average salt intake decreased in intervention group compared with the control group (-4.73 g/day �0.73 versus -0.24 g/day �0.94, P < 0.001), but systolic and diastolic blood pressure did not change significantly in intervention group compared with control group.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rahimdel', 'Affiliation': 'PhD Student in Health Education and Health Promotion, International Campus of Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Morowatisharifabad', 'Affiliation': 'Elderly Health Research Center, School of Public Health, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam BLV, Yazd, Iran.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salehi-Abargouei', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mirzaei', 'Affiliation': 'Yazd Cardiovascular Research Centre, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fallahzadeh', 'Affiliation': 'Department of Statistics and Epidemiology, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",Health education research,['10.1093/her/cyz007']
1538,31065889,Promoting physical activity through a psychological group intervention in cardiac rehabilitation: a randomized controlled trial.,"We examined the long-term effectiveness of a group-based psychological intervention (""MoVo-LISA"") to promote physical activity in patients with coronary heart disease. In this randomized controlled trial, N = 202 inactive patients with coronary heart disease were assigned to the control group (n = 102; treatment as usual) or the intervention group (n = 100; treatment as usual plus MoVo-LISA). Physical activity was assessed at baseline, 6 weeks (post-treatment), 6 months, and 12 months after discharge. ANCOVA for repeated measures revealed a significant interaction effect [p < .001; η  p   2  = .214] indicating a large effect [d = 1.03] of the intervention on behavior change post-treatment. At 12-month follow-up, the level of physical activity in the intervention group was still 94 min per week higher than in the control group (p < .001; d = 0.57). Results of this RCT indicate that the MoVo-LISA intervention substantially improves the level of physical activity among initially inactive patients with coronary heart disease up to 1 year after the intervention.",2019,ANCOVA for repeated measures revealed a significant interaction effect [p < .001; η  p   2  = .214] indicating a large effect [d = 1.03] of the intervention on behavior change post-treatment.,"['cardiac rehabilitation', 'patients with coronary heart disease', 'N\u2009=\u2009202 inactive patients with coronary heart disease']","['psychological group intervention', 'group-based psychological intervention (""MoVo-LISA', 'control group (n\u2009=\u2009102; treatment as usual) or the intervention group (n\u2009=\u2009100; treatment as usual plus MoVo-LISA', 'MoVo-LISA intervention']","['level of physical activity', 'Physical activity']","[{'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",202.0,0.0563131,ANCOVA for repeated measures revealed a significant interaction effect [p < .001; η  p   2  = .214] indicating a large effect [d = 1.03] of the intervention on behavior change post-treatment.,"[{'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Wurst', 'Affiliation': 'Department of Sport Psychology, University of Freiburg, Schwarzwaldstrasse 175, 79117, Freiburg, Germany. Ramona.Wurst@sport.uni-freiburg.de.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kinkel', 'Affiliation': 'Schwarzwaldklinik Bad Krozingen, Herbert-Hellmann-Allee 44, 79189, Freiburg, Germany.'}, {'ForeName': 'Jiaxi', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Sport Psychology, University of Freiburg, Schwarzwaldstrasse 175, 79117, Freiburg, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Goehner', 'Affiliation': 'Catholic University of Applied Sciences, Karlstrasse 63, 79104, Freiburg, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Fuchs', 'Affiliation': 'Department of Sport Psychology, University of Freiburg, Schwarzwaldstrasse 175, 79117, Freiburg, Germany.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00047-y']
1539,31062722,Pulsed dye laser in the treatment of basal cell carcinoma: A single session versus two sessions - a randomized controlled trial.,"Background


Basal cell carcinoma is the most common form of skin cancer worldwide. It has a specialized microvasculature system that can be targeted by the pulsed dye laser using the theory of selective photothermolysis.
Objective


To evaluate the efficacy and safety of single session versus two sessions of pulsed dye laser in the treatment of basal cell carcinoma.
Methods


A total of 22 patients with basal cell carcinoma were collected in this randomized controlled trial. The patients were divided into two groups: Group I - 11 patients were treated by one session of pulsed dye laser, and Group II - 11 patients received two sessions of pulsed dye laser 2 weeks apart. The patients were assessed clinically and histopathologically after end of the treatment.
Results


There was a significant improvement of basal cell carcinoma clinically and histopathologically. Maximal histological clearance rate was achieved in superficial basal cell carcinoma type, small-sized basal cell carcinoma < 0.7 cm and in cases with strong inflammatory response after laser treatment. Treatment of basal cell carcinoma with two sessions of pulsed dye laser was more effective than one session treatment.
Limitations


The small sample size of patients and the limited location of the lesions on the head compared with trunk and extremities. Also, the lack of adequate study power may prevent generalization of results.
Conclusion


Pulsed dye laser proved to be a safe, effective and noninvasive modality for the treatment of basal cell carcinoma that can be used as a monotherapy in small-sized lesions. Also, it can be used to debulk large-sized lesions before surgery.",2019,"Maximal histological clearance rate was achieved in superficial basal cell carcinoma type, small-sized basal cell carcinoma <0.7 cm and in cases with strong inflammatory response after laser treatment.","['basal cell carcinoma', '22 patients with basal cell carcinoma']","['Pulsed dye laser', 'pulsed dye laser']","['basal cell carcinoma', 'Maximal histological clearance rate', 'efficacy and safety']","[{'cui': 'C0007117', 'cui_str': 'Epithelioma, Basal Cell'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1289859', 'cui_str': 'Pulsed Dye Lasers'}]","[{'cui': 'C0007117', 'cui_str': 'Epithelioma, Basal Cell'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",22.0,0.0248382,"Maximal histological clearance rate was achieved in superficial basal cell carcinoma type, small-sized basal cell carcinoma <0.7 cm and in cases with strong inflammatory response after laser treatment.","[{'ForeName': 'Naeim M', 'Initials': 'NM', 'LastName': 'Abd El-Naby', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Nashwa Naeem', 'Initials': 'NN', 'LastName': 'El-Far', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Hanan A', 'Initials': 'HA', 'LastName': 'Al-Shenawy', 'Affiliation': 'Department of Pathology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Sameh E', 'Initials': 'SE', 'LastName': 'Elshwadfy', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Amira A', 'Initials': 'AA', 'LastName': 'Koura', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]","Indian journal of dermatology, venereology and leprology",['10.4103/ijdvl.IJDVL_644_17']
1540,30370463,Parental Reactivity to Disruptive Behavior in Toddlerhood: An Experimental Study.,"Disruptive child behavior is often exacerbated and maintained by negative and inconsistent parenting behavior that unwittingly reinforces disruptive behavior. One explanation for why parents render it difficult to remain positive and consistent might be the impact of disruptive child behavior on parent self-efficacy and stress. This study investigates how disruptive child behavior in a challenging parenting situation shapes parental momentary thoughts of self-efficacy and feelings of stress (i.e., perceived distress and physiological arousal), and how these in turn predict parenting behavior. We experimentally manipulated a challenging parenting situation that was designed to elicit disruptive child behavior. Specifically, we examined: (1) the effects of the challenging condition compared to a control situation on parental state self-efficacy and stress, (2) whether parents with lower trait self-efficacy and higher trait stress in daily life are most affected, and (3) how state self-efficacy and stress predict parental subsequent use of direct commands and positive affect. Parent-toddler dyads were randomly assigned to a challenging or control situation (N = 110, M age  = 30.9 months). As predicted, parents in the challenging situation, relative to control, reported less self-efficacy and more perceived distress, and showed increased physiological arousal. Self-efficacy was compromised particularly in parents with low trait self-efficacy. Our findings suggest that child disruptive behavior drives parental state self-efficacy and stress, especially momentary self-efficacy in parents who generally feel less self-efficacious.",2019,"As predicted, parents in the challenging situation, relative to control, reported less self-efficacy and more perceived distress, and showed increased physiological arousal.","['Toddlerhood', 'Parent-toddler dyads']",[],"['Self-efficacy', 'self-efficacy', 'physiological arousal']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",,0.0205832,"As predicted, parents in the challenging situation, relative to control, reported less self-efficacy and more perceived distress, and showed increased physiological arousal.","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Schulz', 'Affiliation': 'Child Development and Education and Research Priority Area YIELD, University of Amsterdam, PO Box 15780, 1001 NG, Amsterdam, the Netherlands. s.schulz@uu.nl.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Leijten', 'Affiliation': 'Child Development and Education and Research Priority Area YIELD, University of Amsterdam, PO Box 15780, 1001 NG, Amsterdam, the Netherlands.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'University of Pittsburgh, 4101 Sennott Square, 210 South Bouquet Street, Pittsburgh, PA, 15260, USA.'}, {'ForeName': 'Geertjan', 'Initials': 'G', 'LastName': 'Overbeek', 'Affiliation': 'Child Development and Education and Research Priority Area YIELD, University of Amsterdam, PO Box 15780, 1001 NG, Amsterdam, the Netherlands.'}]",Journal of abnormal child psychology,['10.1007/s10802-018-0489-4']
1541,31727284,Initial Imaging-Guided Strategy Versus Routine Care in Patients With Non-ST-Segment Elevation Myocardial Infarction.,"BACKGROUND


Patients with non-ST-segment elevation myocardial infarction and elevated high-sensitivity cardiac troponin levels often routinely undergo invasive coronary angiography (ICA), but many do not have obstructive coronary artery disease.
OBJECTIVES


This study investigated whether cardiovascular magnetic resonance imaging (CMR) or computed tomographic angiography (CTA) may serve as a safe gatekeeper for ICA.
METHODS


This randomized controlled trial (NCT01559467) in 207 patients (age 64 years; 62% male patients) with acute chest pain, elevated high-sensitivity cardiac troponin T levels (>14 ng/l), and inconclusive electrocardiogram compared a CMR- or CTA-first strategy with a control strategy of routine clinical care. Follow-up ICA was recommended when initial CMR or CTA suggested myocardial ischemia, infarction, or obstructive coronary artery disease (≥70% stenosis). Primary efficacy and secondary safety endpoints were referral to ICA during hospitalization and 1-year outcomes (major adverse cardiac events and complications), respectively.
RESULTS


The CMR- and CTA-first strategies reduced ICA compared with routine clinical care (87% [p = 0.001], 66% [p < 0.001], and 100%, respectively), with similar outcome (hazard ratio: CMR vs. routine, 0.78 [95% confidence interval: 0.37 to 1.61]; CTA vs. routine, 0.66 [95% confidence interval: 0.31 to 1.42]; and CMR vs. CTA, 1.19 [95% confidence interval: 0.53 to 2.66]). Obstructive coronary artery disease after ICA was found in 61% of patients in the routine clinical care arm, in 69% in the CMR-first arm (p = 0.308 vs. routine), and in 85% in the CTA-first arm (p = 0.006 vs. routine). In the non-CMR and non-CTA arms, follow-up CMR and CTA were performed in 67% and 13% of patients and led to a new diagnosis in 33% and 3%, respectively (p < 0.001).
CONCLUSIONS


A novel strategy of implementing CMR or CTA first in the diagnostic process in non-ST-segment elevation myocardial infarction is a safe gatekeeper for ICA.",2019,"The CMR- and CTA-first strategies reduced ICA compared with routine clinical care (87% [p = 0.001], 66% [p < 0.001], and 100%, respectively), with similar outcome (hazard ratio:","['Patients', '207 patients (age 64 years; 62% male patients) with acute chest pain, elevated high-sensitivity cardiac troponin T levels (>14\xa0ng/l), and inconclusive electrocardiogram compared a CMR- or CTA-first strategy with a control strategy of routine clinical care', 'Patients with non-ST-segment elevation myocardial infarction and elevated high-sensitivity cardiac troponin levels often routinely undergo']","['invasive coronary angiography (ICA', 'cardiovascular magnetic resonance imaging (CMR) or computed tomographic angiography (CTA', 'Initial Imaging-Guided Strategy']","['myocardial ischemia, infarction, or obstructive coronary artery disease', 'Obstructive coronary artery disease', 'referral to ICA during hospitalization and 1-year outcomes (major adverse cardiac events and complications), respectively']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0522051', 'cui_str': 'Acute chest pain (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C3538889', 'cui_str': 'Cardiac troponin T (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C1629507', 'cui_str': 'Inconclusive'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",207.0,0.106654,"The CMR- and CTA-first strategies reduced ICA compared with routine clinical care (87% [p = 0.001], 66% [p < 0.001], and 100%, respectively), with similar outcome (hazard ratio:","[{'ForeName': 'Martijn W', 'Initials': 'MW', 'LastName': 'Smulders', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands; Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Bas L J H', 'Initials': 'BLJH', 'LastName': 'Kietselaer', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands; Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands; Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Joachim E', 'Initials': 'JE', 'LastName': 'Wildberger', 'Affiliation': 'Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands; Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Dagnelie', 'Affiliation': 'Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands; Department of Internal Medicine, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Brunner-La Rocca', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands; Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Alma M A', 'Initials': 'AMA', 'LastName': 'Mingels', 'Affiliation': 'Department of Clinical Chemistry, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Yvonne J M', 'Initials': 'YJM', 'LastName': 'van Cauteren', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands; Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands; Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Ralph A L J', 'Initials': 'RALJ', 'LastName': 'Theunissen', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Post', 'Affiliation': 'Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands; Department of Physiology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Schalla', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands; Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands; Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Sander M J', 'Initials': 'SMJ', 'LastName': 'van Kuijk', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': 'Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands; Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, the Netherlands; Department of Diagnostic and Interventional Radiology, Helios Klinikum, Duisburg, Germany.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Kim', 'Affiliation': 'Duke Cardiovascular Magnetic Resonance Center, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Harry J G M', 'Initials': 'HJGM', 'LastName': 'Crijns', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands; Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Sebastiaan C A M', 'Initials': 'SCAM', 'LastName': 'Bekkers', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands; Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands; Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, the Netherlands. Electronic address: s.bekkers@mumc.nl.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.027']
1542,31090747,Subcrestal placement of dental implants with an internal conical connection of 0.5 mm versus 1.5 mm: Three-year after loading results of a multicentre within-person randomised controlled trial.,"PURPOSE


To evaluate whether there are some clinical benefits by placing single dental implants either 0.5 mm or 1.5 mm subcrestally in healed bone crests.
MATERIALS AND METHODS


Sixty partially edentulous patients requiring two single implant-supported crowns had both sites randomly allocated either to 0.5-mm or 1.5-mm subcrestal implant placement according to a split-mouth design at six centres and submerged in aesthetic areas or non-submerged in non-aesthetic areas for 3 months. Provisional acrylic crowns were delivered and were replaced after 2 months by definitive metal-ceramic crowns. Patients were followed to 3 years after loading. Outcome measures were: crown and implant failures, complications, aesthetics assessed using the pink aesthetic score (PES), peri-implant marginal bone level changes and patient preference, recorded by blinded assessors.
RESULTS


One patient dropped out. One patient lost both implants for infection at impression taking. Seven complications affected seven patients of the 0.5-mm group and four complications affected four patients of the 1.5-mm subcrestal group. Three patients had complications at both implants. There were no statistically significant differences for complications between group (OR = 4; 95% CI: 0.45 to 35.79; P (McNemar test) = 0.375). At delivery of definitive crowns, 2 months after loading, the mean PES was 11.22 ± 1.91 and 11.12 ± 1.59 for the 0.5- and 1.5-mm groups, respectively. At 1 year after loading, the mean PES was 12.09 ± 1.66 and 12.10 ± 1.52 for the 0.5- and 1.5-mm groups, respectively. At 3 years after loading, the mean PES was 11.99 ± 1.94 and 12.19 ± 1.78 for the 0.5- and 1.5-mm groups, respectively. There were no statistically significant differences between the two groups at 2 months (P = 0.626), at 1 year (P = 0.920) or at 3 years (P = 0.296). One year after loading, patients of the 0.5-mm group lost on average 0.21 ± 0.51 mm and those of the 1.5-mm group 0.11 ± 0.36 mm, the difference being not statistically significant (difference = 0.10 mm; 95% CI: -0.01 to 0.20; P = 0.078). Three years after loading, patients of the 0.5-mm group lost on average 0.34 ± 0.87 mm and those of the 1.5-mm group 0.19 ± 0.54 mm, the difference being statistically significant (difference = 0.15 mm; 95% CI: 0.00 to 0.30; P = 0.046). Patients did not prefer any depth of the implant placement over the other. There were no differences in outcomes between centres.
CONCLUSIONS


No appreciable clinical differences were noticed when placing implants 0.5 mm or 1.5 mm subcrestally; therefore clinicians can do as they prefer.",2019,There were no statistically significant differences for complications between group (OR = 4; 95% CI: 0.45 to 35.79; P (McNemar test) = 0.375).,['Sixty partially edentulous patients requiring two single implant-supported crowns had both sites randomly allocated either to 0.5-mm or 1.5-mm'],"['Provisional acrylic crowns', 'subcrestal implant placement according to a split-mouth design at six centres and submerged in aesthetic areas or non-submerged in non-aesthetic areas for 3 months']","['crown and implant failures, complications, aesthetics assessed using the pink aesthetic score (PES), peri-implant marginal bone level changes and patient preference, recorded by blinded assessors', 'complications']","[{'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0440181', 'cui_str': 'Acrylic dental material (substance)'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0854676', 'cui_str': 'Failure of implant'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0332585', 'cui_str': 'Pink color (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]",,0.260727,There were no statistically significant differences for complications between group (OR = 4; 95% CI: 0.45 to 35.79; P (McNemar test) = 0.375).,"[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Salina', 'Affiliation': ''}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Gualini', 'Affiliation': ''}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Rigotti', 'Affiliation': ''}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Mazzarini', 'Affiliation': ''}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Longhin', 'Affiliation': ''}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Grigoletto', 'Affiliation': ''}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Buti', 'Affiliation': ''}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Sbricoli', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Esposito', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1543,30332535,The Lulun Project's social marketing strategy in a trial to introduce eggs during complementary feeding in Ecuador.,"The Lulun Project incorporated a social marketing strategy that accompanied a randomized controlled trial (RCT) of a food-based intervention that introduced eggs into the complementary feeding diet of Ecuadorian infants. This strategy was designed to promote behaviour change, in this case, egg consumption, through voluntary prosocial behaviour, empowerment, and brand loyalty. A three-phase social marketing strategy (design, campaigns, and evaluation) contributed to our successful RTC by applying techniques drawn from marketing, publicity, design, and communications. To develop the strategy, we conducted (a) market research focused on culturally based norms, values, and local expectations; (b) a situational assessment based on the four Ps of social marketing (people, product, place, and price); and (c) fostered a creative process to develop the project's brand and communication plan. The strategy combined a communication plan, brand, and activities that were implemented in four campaigns: outreach, recruitment, promotion, and closing. Our evaluation showed that the social marketing strategy was instrumental in promoting the RCT's objectives and responding to unforeseen events and community concerns regarding the RCT. The strategy resulted in high compliance, low attrition, and infant feeding policy change, including Ecuador's Ministry of Public Health new complementary feeding guidelines for introducing eggs early in complementary feeding. Use of social marketing techniques, like those in our study, could be key for scaling up this food-based intervention-or others like it-in Ecuador and beyond.",2018,Our evaluation showed that the social marketing strategy was instrumental in promoting the RCT's objectives and responding to unforeseen events and community concerns regarding the RCT.,['Ecuadorian infants'],[],[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}]",[],[],,0.0284191,Our evaluation showed that the social marketing strategy was instrumental in promoting the RCT's objectives and responding to unforeseen events and community concerns regarding the RCT.,"[{'ForeName': 'Carlos Andres', 'Initials': 'CA', 'LastName': 'Gallegos-Riofrío', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Waters', 'Affiliation': 'Institute for Research in Health and Nutrition, Universidad San Francisco de Quito, Quito, Ecuador.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Salvador', 'Affiliation': ""Rockin' Business, Quito, Ecuador.""}, {'ForeName': 'Amaya M', 'Initials': 'AM', 'LastName': 'Carrasco', 'Affiliation': 'Institute for Research in Health and Nutrition, Universidad San Francisco de Quito, Quito, Ecuador.'}, {'ForeName': 'Chessa K', 'Initials': 'CK', 'LastName': 'Lutter', 'Affiliation': 'RTI International, Washington, District of Columbia, USA.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Iannotti', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, Missouri, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12700']
1544,31734088,A contra-lateral comparison of the visual effects of a photochromic vs. non-photochromic contact lens.,"PURPOSE


To compare the effects of a photochromic contact lens vs. a non-photochromic control lens on visual function.
METHODS


A subject-masked, prospective contralateral eye design was used. Sixty-one subjects were enroled based on age (using a 2:1 allocation ratio for ages 18-39 and 40-65 years, respectively). The study lenses were senofilcon A with photochromic additive (Test) that filtered over the entire lens, compared to a non-photochromic Control with no tint. The Test lens was partially activated during testing with a steady-state transmittance of approximately 62%. Eligible subjects were tested using both study lenses, with Test and Control lens randomized by eye. Five visual function outcomes were tested: photostress recovery (PSR), glare disability (GD), glare discomfort (GDC), chromatic contrast (CC) and vernier acuity (VA). Iris colour and macular pigment density were assessed as control variables. PSR was measured as the time needed to recover sight of a target after an intense xenon flash exposure; GD was evaluated as the energy needed to veil a central target by a surrounding xenon annulus; GDC was measured using bio-imaging of the squint response and by self-report using a 9-item Likert scale; CC was measured as thresholds for a yellow grating target superposed on a 460-nm background; VA was determined by measuring vernier offsets of light lines through apertures.
RESULTS


Based on our stimulus conditions, PSR was 43% faster using the Test vs. the Control. The eye wearing the Test had 38% less squint (GDC) compared to the Control. GD was improved by 36% in the Test vs. Control and CC was enhanced by 48% with the Test. There was no significant difference in VA.
CONCLUSIONS


There was a beneficial influence on visual function when comparing the photochromic with the non-photochromic contact lens. This benefit was seen specifically with respect to PRT, GDC, GD and CC thresholds.",2020,There was a beneficial influence on visual function when comparing the photochromic with the non-photochromic contact lens.,"['Eligible subjects', 'Sixty-one subjects were enroled based on age (using a 2:1 allocation ratio for ages 18-39 and 40-65 years, respectively']","['photochromic vs. non-photochromic contact lens', 'photochromic contact lens vs. a non-photochromic control lens']","['PSR', 'GD', 'Iris colour and macular pigment density', 'visual function', 'VA', 'photostress recovery (PSR), glare disability (GD), glare discomfort (GDC), chromatic contrast (CC) and vernier acuity (VA']","[{'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}]","[{'cui': 'C0022077', 'cui_str': 'Iris'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C1321306', 'cui_str': 'Glare disability'}, {'cui': 'C3887688', 'cui_str': 'Glare (finding)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0392714', 'cui_str': 'Vernier acuity (observable entity)'}]",61.0,0.0328088,There was a beneficial influence on visual function when comparing the photochromic with the non-photochromic contact lens.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Renzi-Hammond', 'Affiliation': 'Human Biofactors Laboratory, Institute of Gerontology, Department of Health Promotion and Behavior, University of Georgia, Athens, GA 30602, United States. Electronic address: lrenzi@uga.edu.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Buch', 'Affiliation': 'Johnson & Johnson Vision Care, Inc., United States. Electronic address: Jbuch@its.jnj.com.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cannon', 'Affiliation': 'Johnson & Johnson Vision Care, Inc., United States. Electronic address: jcannon@its.jnj.com.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hacker', 'Affiliation': 'Georgia Center for Sight, Greensboro, GA 30642, United States. Electronic address: hackerlauren@gmail.com.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Toubouti', 'Affiliation': 'Johnson & Johnson Vision Care, Inc., United States. Electronic address: Ytoubouti@its.jnj.com.'}, {'ForeName': 'Billy R', 'Initials': 'BR', 'LastName': 'Hammond', 'Affiliation': 'Vision Sciences Laboratory, Behavioral and Brain Sciences Program, Department of Psychology, University of Georgia, Athens, GA, 30602, Greece. Electronic address: bhammond@uga.edu.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2019.10.138']
1545,30927417,Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial.,"STUDY QUESTION


Is oral medroxiprogesterone acetate (MPA) non-inferior compared to ganirelix with respect to the number of mature oocytes (MII) retrieved at ovum pick-up (OPU) in oocyte donation cycles?
SUMMARY ANSWER


MPA is comparable to ganirelix in terms of number of MII retrieved at OPU in oocyte donation cycles.
WHAT IS KNOWN ALREADY


Oral treatment with MPA inhibits the pituitary LH surge during ovarian stimulation in infertile patients. Because of its negative effect on the endometrium, MPA suppression is combined with freeze-all. Published reports indicate that both the number of MII retrieved and pregnancy rates from these oocytes are comparable to short protocol of GnRH agonists during IVF cycles with freeze-all. MPA might allow for more comfortable and cost-effective ovarian stimulation.
STUDY DESIGN, SIZE, DURATION


Randomized clinical trial, open-label, single center, to assess the non-inferiority of MPA (10 mg/day) versus ganirelix (0.25 mg/day) from Day 7, in ovarian stimulation cycles triggered with triptoreline acetate. Trigger criterion was ≥3 follicles of diameter >18 mm.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Overall, 252 oocyte donors were selected (eligible), 216 were randomized and 173 reached OPU: 86 under MPA and 87 under ganirelix. The main outcome was the number of MII retrieved at OPU. Secondary outcomes were embryological laboratory outcomes and reproductive outcomes in recipients. The study was powered to test that the lower limit of the 95% confidence interval of the difference in retrieved MII between groups will be above the non-inferiority limit of -3. Differences were tested using a two-sided Student's t-test or a Pearson's Chi2 test, as appropriate.
MAIN RESULTS AND THE ROLE OF CHANCE


All participants were in their first cycle of oocyte donation. On average, donors were 24 (SD 4.5) years old and with a BMI of 23 (SD 2.9) kg/m2. Duration of stimulation was similar in both groups (11.2 days), as well as the total gonadotropin dose up to trigger (2162 IU in MPA and 2163 IU in ganirelix). The number of MII retrieved was no different: 15.1 (SD 8.3) with MPA and 14.6 (SD 7.0), 95% CI of the difference -2.78, -1.83 excluding the pre-defined non-inferiority limit (-3). Recipients and embryo transfer (ET) characteristics were also similar between groups. The average age of recipients was 42 (SD 4.8) years and the BMI was 24 (SD 4.4) kg/m2. The mean number of MII assigned to each recipients was 6.7 (SD 1.2) in MPA and 6.6 (SD 1.2) in ganirelix (P = 0.58). MII were fertilized with partner sperm in 84% cycles overall and fertilization rate was 76% in MPA versus 74% in ganirelix (P = 0.34). Overall, there was 54% of double ET and 46% of single ET, with 40% of ETs were performed in D5. In spite of similar recipients and cycle characteristics, reproductive outcomes were unexpectedly lower with MPA. Biochemical pregnancy rate was 44 versus 57% (P = 0.023); clinical pregnancy rate 31 versus 46% (P = 0.006); ongoing pregnancy rate 27 versus 40%, (P = 0.015) and live birth rate 22 versus 31%, (P = 0.10).
LIMITATIONS, REASONS FOR CAUTION


Although oocyte recipient and ET characteristics are similar among groups, this RCT has been designed under a hypothesis of non-inferiority in the number of MII obtained and recipients were not randomized; therefore, the reproductive outcomes in recipients should be evaluated with extreme caution.
WIDER IMPLICATION OF THE FINDINGS


Ovarian stimulation using MPA for prevention of LH surge yields comparable number of MII oocytes compared to ganirelix in oocyte donation cycles. The unexpected finding in reproductive outcomes should be further investigated.
STUDY FUNDING/COMPETING INTEREST(S)


None to report.
TRIAL REGISTRATION NUMBER


EudraCT number: 2015-004328-73; ClinicalTrials.gov Identifier: NCT02796105.
TRIAL REGISTRATION DATE


29 September 2015 (EudraCT); 9 June 2016 (ClinicalTrials.gov).
DATE OF FIRST PATIENT’S ENROLLMENT


The date of enrollment of the first participant was 07 July 2016, and the last participant last visit in the study was on 10 July 2017.",2019,"Biochemical pregnancy rate was 44 versus 57% (P = 0.023); clinical pregnancy rate 31 versus 46% (P = 0.006); ongoing pregnancy rate 27 versus 40%, (P = 0.015) and live birth rate 22 versus 31%, (P = 0.10).
","['29 September 2015 (EudraCT); 9 June 2016 (ClinicalTrials.gov', '’S', 'average age of recipients was 42 (SD 4.8) years and the BMI was 24 (SD 4.4) kg/m2', 'oocyte donation', 'On average, donors were 24 (SD 4.5) years old and with a BMI of 23 (SD 2.9) kg/m2', 'first participant was 07 July 2016, and the last participant last visit in the study was on 10 July 2017', 'infertile patients', 'Overall, 252 oocyte donors were selected (eligible), 216 were randomized and 173 reached OPU: 86 under MPA and 87 under ganirelix']","['Medroxyprogesterone acetate versus ganirelix', 'ganirelix', 'triptoreline acetate', 'medroxiprogesterone acetate (MPA', 'MPA']","['fertilization rate', 'embryological laboratory outcomes and reproductive outcomes', 'Biochemical pregnancy rate', 'Duration of stimulation', 'mean number of MII', 'live birth rate', 'number of MII retrieved at OPU', 'clinical pregnancy rate', 'ongoing pregnancy rate', 'number of MII', 'embryo transfer (ET) characteristics']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0242813', 'cui_str': 'Oocyte Donation'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3267027', 'cui_str': 'Oocyte donor'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0073629', 'cui_str': 'ganirelix'}]","[{'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0073629', 'cui_str': 'ganirelix'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]",,0.331495,"Biochemical pregnancy rate was 44 versus 57% (P = 0.023); clinical pregnancy rate 31 versus 46% (P = 0.006); ongoing pregnancy rate 27 versus 40%, (P = 0.015) and live birth rate 22 versus 31%, (P = 0.10).
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Beguería', 'Affiliation': 'Clínica EUGIN, Travessera de les Corts 322, Barcelona, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'García', 'Affiliation': 'Clínica EUGIN, Travessera de les Corts 322, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vassena', 'Affiliation': 'Clínica EUGIN, Travessera de les Corts 322, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rodríguez', 'Affiliation': 'Clínica EUGIN, Travessera de les Corts 322, Barcelona, Spain.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez034']
1546,31056427,"CAL02, a novel antitoxin liposomal agent, in severe pneumococcal pneumonia: a first-in-human, double-blind, placebo-controlled, randomised trial.","BACKGROUND


Severe community-acquired pneumonia caused by Streptococcus pneumoniae is associated with high morbidity and mortality rates. CAL02, a novel antitoxin agent with an unprecedented mode of action, consists of liposomes that capture bacterial toxins known to dysregulate inflammation, cause organ damage, and impede immune defence. We aimed to assess the safety of CAL02 as an add-on therapy to antibiotics.
METHODS


This randomised, double-blind, multicentre, placebo-controlled trial was done in ten intensive care units (ICUs) in France and Belgium (but only six units enrolled patients), in patients with severe community-acquired pneumococcal pneumonia who required ICU admission and had been identified as being infected with S pneumoniae. We randomly assigned participants in two stages-the first stage randomly assigned six patients (1:1) to either low-dose CAL02 or placebo, and the second stage randomly assigned 18 patients (14:4) to either high-dose CAL02 or placebo, and stratified in four blocks (4:1, 4:1, 3:1, and 3:1), in addition to standard of care. Block randomisation was done with a computer-generated random number list. Participants, investigators, other site study personnel, the sponsor, and the sponsor's designees involved in study management and monitoring were masked to the randomisation list and treatment assignment. Patients were treated with low-dose (4 mg/kg) or high-dose (16 mg/kg) CAL02 or placebo (saline), in addition to standard antibiotic therapy. Two intravenous doses of study treatment were infused, with a 24 h interval, at a concentration of 10 mg/mL, stepwise, over a maximum of 2 h on days 1 and 2. The primary objective of the study was to assess the safety and tolerability of low-dose and high-dose CAL02 in patients with severe community-acquired pneumonia treated with standard antibiotic therapy, and the primary analysis was done on the safety population (all patients who received at least one dose of the study treatment). Efficacy was a secondary outcome. This trial is registered with ClinicalTrials.gov, number NCT02583373.
FINDINGS


Between March 21, 2016, and Jan 13, 2018, we screened 280 patients with community-acquired pneumonia. 19 patients were enrolled and randomly assigned, resulting in 13 patients in the CAL02 groups (three assigned to low-dose CAL02 and ten assigned to high-dose CAL02) and six in the placebo group. One patient randomly assigned to placebo was allocated to the wrong treatment group and received high-dose CAL02 instead of placebo. Thus, 14 patients received CAL02 (three received low-dose CAL02 and 11 received high-dose CAL02) and five patients received placebo, constituting the safety population. At baseline, the mean APACHE II score for the total study population was 21·5 (SD 4·9; 95% CI 19·3-23·7) and 11 (58%) of 19 patients had septic shock. Adverse events occurred in 12 (86%) of 14 patients in the CAL02 treatment groups combined and all five (100%) patients in the placebo group. Serious adverse events occurred in four (29%) of 14 patients in the CAL02 treatment groups combined and two (40%) of five patients in the placebo group. One non-serious adverse event (mild increase in triglycerides) in a patient in the high-dose CAL02 group was reported as related to study drug. However, analysis of the changes in triglyceride levels in the CAL02 groups compared with the placebo group revealed no correlation with administration of CAL02. No adverse events were linked to local tolerability events. All patients, apart from one who died in the low CAL02 group (death not related to the study drug) achieved clinical cure at the test of cure visit between days 15 and 22. The sequential organ failure assessment score decreased by mean 65·0% (95% CI 50·7-79·4) in the combined CAL02 groups compared with 29·2% (12·8-45·5) in the placebo group between baseline and day 8.
INTERPRETATION


The nature of adverse events was consistent with the profile of the study population and CAL02 showed a promising safety profile and tolerability. However, the difference between high-dose and low-dose CAL02 could not be assessed in this study. Efficacy was in line with the expected benefits of neutralising toxins. The results of this study support further clinical development of CAL02 and provide a solid basis for a larger clinical study.
FUNDING


Combioxin.",2019,One non-serious adverse event (mild increase in triglycerides) in a patient in the high-dose CAL02 group was reported as related to study drug.,"['280 patients with community-acquired pneumonia', 'severe pneumococcal pneumonia', '19 patients', 'ten intensive care units (ICUs) in France and Belgium (but only six units enrolled patients), in patients with severe community-acquired pneumococcal pneumonia who required ICU admission and had been identified as being infected with S pneumoniae', '14 patients received', 'patients with severe community-acquired pneumonia treated with standard antibiotic therapy, and the primary analysis was done on the safety population (all patients who received at least one dose of the study treatment']","['CAL02 (three received low-dose CAL02 and 11 received high-dose CAL02', 'placebo', 'low-dose CAL02 and ten assigned to high-dose CAL02', 'CAL02 or placebo (saline', 'low-dose and high-dose CAL02', 'CAL02', 'high-dose CAL02 instead of placebo', 'low-dose CAL02 or placebo', 'high-dose CAL02 or placebo']","['Efficacy', 'triglycerides', 'safety profile and tolerability', 'Adverse events', 'safety and tolerability', 'sequential organ failure assessment score', 'septic shock', 'triglyceride levels', 'clinical cure', 'Serious adverse events', 'mean APACHE II score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0155862', 'cui_str': 'Pneumonia, Pneumococcal'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0456394', 'cui_str': 'Community acquired (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}]",19.0,0.704638,One non-serious adverse event (mild increase in triglycerides) in a patient in the high-dose CAL02 group was reported as related to study drug.,"[{'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Laterre', 'Affiliation': 'Intensive Care Unit, Cliniques Universitaires Saint-Luc, Université catholique de Louvain (UCL), Brussels, Belgium. Electronic address: pierre-francois.laterre@uclouvain.be.'}, {'ForeName': 'Gwenhael', 'Initials': 'G', 'LastName': 'Colin', 'Affiliation': 'Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon, France.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Dequin', 'Affiliation': 'Medical-Surgical Intensive Care Unit, University Hospital, Tours, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Dugernier', 'Affiliation': 'Soins Intensifs, Clinique Saint-Pierre, Ottignies, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Boulain', 'Affiliation': ""Service de Médecine Intensive Réanimation, Hôpital La Source, Centre Hospitalier Régional d'Orléans, Orléans, France.""}, {'ForeName': 'Samareh', 'Initials': 'S', 'LastName': 'Azeredo da Silveira', 'Affiliation': 'Combioxin, Geneva, Switzerland.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Lajaunias', 'Affiliation': 'Combioxin, Geneva, Switzerland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Combioxin, Geneva, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'François', 'Affiliation': 'Medical-Surgical Intensive Care Unit, University Hospital Limoges Dupuytren Hospital, Limoges, France; Inserm CIC-1435, University Hospital Limoges Dupuytren Hospital, Limoges, France; Inserm UMR 1092, Faculté de Médecine, Université de Limoges, Limoges, France.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30805-3']
1547,30926325,Mindfulness-based therapy modulates default-mode network connectivity in patients with opioid dependence.,"Recently, mindfulness-based programs have shown promising clinical effects in the treatment of substance-use disorders (SUD). While several studies linked mindfulness to decreased default mode network (DMN) connectivity in meditators, only a few studies investigated its effects in patients with SUD. This study aimed to detect changes in DMN connectivity in opiate dependent patients receiving mindfulness based therapy (MBT) during their first month of treatment. Data from 32 patients that were assigned to MBT or treatment as usual (TAU) groups was investigated using resting-state functional MRI at 1.5 T before and after four weeks of treatment. Independent Component Analysis was used to investigate distinct (anterior vs. posterior) DMN subsystems. Connectivity changes after treatment were related to measures of impulsivity, distress tolerance and mindfulness. Increased mindfulness scores after treatment were found in patients receiving MBT compared to TAU. Within the anterior DMN, decreased right inferior frontal cortical connectivity was detected in patients who received MBT compared to TAU. In addition, within the MBT-group decreased right superior frontal cortex connectivity was detected after treatment. Inferior frontal cortex function was significantly associated with mindfulness measures. The data suggest that MBT can be useful during abstinence from opiates. In opiate-dependent patients distinct functional connectivity changes within the DMN are associated with MBT.",2019,"Within the anterior DMN, decreased right inferior frontal cortical connectivity was detected in patients who received MBT compared to TAU.","['patients with opioid dependence', 'patients with SUD', '32 patients that were assigned to', 'opiate dependent patients receiving mindfulness based therapy (MBT) during their first month of treatment']","['Mindfulness-based therapy', 'MBT']","['right inferior frontal cortical connectivity', 'DMN connectivity', 'right superior frontal cortex connectivity', 'Inferior frontal cortex function', 'Increased mindfulness scores', 'impulsivity, distress tolerance and mindfulness', 'Connectivity changes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524662', 'cui_str': 'Opiate Dependence'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0016733', 'cui_str': 'Frontal Cortex'}, {'cui': 'C0582740', 'cui_str': 'Inferior frontal cortex (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",32.0,0.01576,"Within the anterior DMN, decreased right inferior frontal cortical connectivity was detected in patients who received MBT compared to TAU.","[{'ForeName': 'Reham', 'Initials': 'R', 'LastName': 'Fahmy', 'Affiliation': 'Department of Psychiatry, Kasralainy Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Wasfi', 'Affiliation': 'Department of Psychiatry, Kasralainy Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Mamdouh', 'Affiliation': 'Department of Psychiatry, Kasralainy Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Kareem', 'Initials': 'K', 'LastName': 'Moussa', 'Affiliation': 'Department of Radiology, Kasralainy Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Wahba', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Marburg University, Germany.'}, {'ForeName': 'Mike M', 'Initials': 'MM', 'LastName': 'Schmitgen', 'Affiliation': 'Center for Psychosocial Medicine, Department of General Psychiatry, Heidelberg University, Voßstraße 4, 69115 Heidelberg, Germany.'}, {'ForeName': 'Katharina M', 'Initials': 'KM', 'LastName': 'Kubera', 'Affiliation': 'Center for Psychosocial Medicine, Department of General Psychiatry, Heidelberg University, Voßstraße 4, 69115 Heidelberg, Germany.'}, {'ForeName': 'Nadine D', 'Initials': 'ND', 'LastName': 'Wolf', 'Affiliation': 'Center for Psychosocial Medicine, Department of General Psychiatry, Heidelberg University, Voßstraße 4, 69115 Heidelberg, Germany.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Sambataro', 'Affiliation': 'Department of Experimental and Clinical Medical Sciences (DISM), University of Udine, Udine, Italy.'}, {'ForeName': 'Robert Christian', 'Initials': 'RC', 'LastName': 'Wolf', 'Affiliation': 'Center for Psychosocial Medicine, Department of General Psychiatry, Heidelberg University, Voßstraße 4, 69115 Heidelberg, Germany. Electronic address: christian.wolf@med.uni-heidelberg.de.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.03.002']
1548,30928180,Neurochemical effects of oxytocin in people at clinical high risk for psychosis.,"Alterations in neurochemical metabolites are thought to play a role in the pathophysiology of psychosis onset. Oxytocin, a neuropeptide with prosocial and anxiolytic properties, modulates glutamate neurotransmission in preclinical models but its neurochemical effects in people at high risk for psychosis are unknown. We used proton magnetic resonance spectroscopy ( 1 H-MRS) to examine the effects of intranasal oxytocin on glutamate and other metabolites in people at Clinical High Risk for Psychosis (CHR-P) in a double-blind, placebo-controlled, crossover design. 30 CHR-P males were studied on two occasions, once after 40IU intranasal oxytocin and once after placebo. The effects of oxytocin on the concentration of glutamate, glutamate+glutamine and other metabolites (choline, N-acetylaspartate, myo-inositol) scaled to creatine were examined in the left thalamus, anterior cingulate cortex (ACC) and left hippocampus, starting approximately 75, 84 and 93 min post-dosing, respectively. Relative to placebo, administration of oxytocin was associated with an increase in choline levels in the ACC (p=.008, Cohen's d = 0.54). There were no other significant effects on metabolite concentrations (all p>.05). Our findings suggest that, at ∼75-99 min post-dosing, a single dose of intranasal oxytocin does not alter levels of neurochemical metabolites in the thalamus, ACC, or hippocampus in those at CHR-P, aside from potential effects on choline in the ACC.",2019,"Relative to placebo, administration of oxytocin was associated with an increase in choline levels in the ACC (p=.008, Cohen's d = 0.54).","['people at Clinical High Risk for Psychosis (CHR-P', 'people at clinical high risk for psychosis', '30 CHR-P males']","['placebo', 'proton magnetic resonance spectroscopy ( 1 H-MRS', 'intranasal oxytocin', 'Oxytocin', 'oxytocin']","['choline levels', 'metabolite concentrations', 'concentration of glutamate, glutamate+glutamine and other metabolites (choline, N-acetylaspartate, myo-inositol) scaled to creatine', 'levels of neurochemical metabolites']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl aspartate'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0222045'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}]",,0.286814,"Relative to placebo, administration of oxytocin was associated with an increase in choline levels in the ACC (p=.008, Cohen's d = 0.54).","[{'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Davies', 'Affiliation': ""Early Psychosis: Interventions & Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 16 De Crespigny Park, London SE5 8AF, UK. Electronic address: cathy.davies@kcl.ac.uk.""}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Rutigliano', 'Affiliation': ""Early Psychosis: Interventions & Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 16 De Crespigny Park, London SE5 8AF, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'De Micheli', 'Affiliation': ""Early Psychosis: Interventions & Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 16 De Crespigny Park, London SE5 8AF, UK; National Institute for Health Research (NIHR) Biomedical Research Centre (BRC), South London and Maudsley NHS Foundation Trust, London, UK.""}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Stone', 'Affiliation': ""National Institute for Health Research (NIHR) Biomedical Research Centre (BRC), South London and Maudsley NHS Foundation Trust, London, UK; Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ramella-Cravaro', 'Affiliation': ""Early Psychosis: Interventions & Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 16 De Crespigny Park, London SE5 8AF, UK.""}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Provenzani', 'Affiliation': ""Early Psychosis: Interventions & Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 16 De Crespigny Park, London SE5 8AF, UK; Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cappucciati', 'Affiliation': ""Early Psychosis: Interventions & Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 16 De Crespigny Park, London SE5 8AF, UK.""}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Scutt', 'Affiliation': ""Early Psychosis: Interventions & Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 16 De Crespigny Park, London SE5 8AF, UK.""}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Paloyelis', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Oliver', 'Affiliation': ""Early Psychosis: Interventions & Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 16 De Crespigny Park, London SE5 8AF, UK.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Murguia', 'Affiliation': 'Tower Hamlets Early Detection Service (THEDS), East London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Zelaya', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Allen', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK; Department of Psychology, University of Roehampton, London, UK.""}, {'ForeName': 'Sukhi', 'Initials': 'S', 'LastName': 'Shergill', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Morrison', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': ""Institute of Pharmaceutical Science, King's College London, London, UK.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lythgoe', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McGuire', 'Affiliation': ""National Institute for Health Research (NIHR) Biomedical Research Centre (BRC), South London and Maudsley NHS Foundation Trust, London, UK; Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK; Outreach and Support in South London (OASIS) Service, South London and Maudsley NHS Foundation Trust, London, UK.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fusar-Poli', 'Affiliation': ""Early Psychosis: Interventions & Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, 16 De Crespigny Park, London SE5 8AF, UK; National Institute for Health Research (NIHR) Biomedical Research Centre (BRC), South London and Maudsley NHS Foundation Trust, London, UK; Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy; Outreach and Support in South London (OASIS) Service, South London and Maudsley NHS Foundation Trust, London, UK.""}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.03.008']
1549,31043102,Who Can Get More Benefits? Effects of Mindfulness Training in Long-Term and Short-Term Male Prisoners.,"The aim of the present study was to examine the effects of a 6-week mindfulness training program on mental health, anxiety, depression, aggression, sleep quality, mood states, total mood disturbance, and perceived stress among male Chinese prisoners, and to explore whether the intervention effects differed in long-term and short-term prisoners. Eighty-three male prisoners completed the study, including 39 in the mindfulness training group and 44 in the waitlist control group. Results showed that, compared with the waitlist control group, mindfulness training group showed a significant improvement in mindfulness level ( p  < .0l), Symptom Checklist-90 (SCL-90;  p  < .00l), aggression ( p  < .05), sleep quality ( p  < .05), and total mood disturbance ( p  < .0l). Moreover, compared with the short-term prisoners, mindfulness training was more effective on the long-term prisoners in mindfulness level ( p  < .05), SCL-90 ( p  < .001), anxiety ( p  < .05), depression ( p  < .05), aggression ( p  < .05), total mood disturbance ( p  < .0l), and perceived stress ( p  < .0l). Given the study's innovation, we discussed its significance and limitations.",2019,"Moreover, compared with the short-term prisoners, mindfulness training was more effective on the long-term prisoners in mindfulness level ( p < .05), SCL-90 ( p < .001), anxiety ( p < .05), depression ( p < .05), aggression ( p < .05), total mood disturbance ( p < .0l), and perceived stress ( p < .0l).","['Long-Term and Short-Term Male Prisoners', 'Eighty-three male prisoners completed the study, including 39 in the mindfulness training group and 44 in the waitlist control group', 'male Chinese prisoners']","['mindfulness training program', 'Mindfulness Training']","['mindfulness level', 'depression', 'aggression', 'anxiety', 'sleep quality', 'SCL-90', 'Symptom Checklist-90', 'total mood disturbance', 'mental health, anxiety, depression, aggression, sleep quality, mood states, total mood disturbance, and perceived stress']","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",83.0,0.0138623,"Moreover, compared with the short-term prisoners, mindfulness training was more effective on the long-term prisoners in mindfulness level ( p < .05), SCL-90 ( p < .001), anxiety ( p < .05), depression ( p < .05), aggression ( p < .05), total mood disturbance ( p < .0l), and perceived stress ( p < .0l).","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'An', 'Affiliation': '1 Nanjing Normal University, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': '1 Nanjing Normal University, China.'}, {'ForeName': 'Yucheng', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': '1 Nanjing Normal University, China.'}, {'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': '2 Shanghai International Studies University, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': '1 Nanjing Normal University, China.'}]",International journal of offender therapy and comparative criminology,['10.1177/0306624X19846771']
1550,30222505,An Intervention Tool to Increase Patient-Physician Discussion of Lifestyle Risk Factors for Breast Cancer.,"Background:  Risk assessment and discussion of lifestyle in primary care are crucial elements of breast cancer prevention and risk reduction. Our objective was to evaluate the impact of a breast cancer risk assessment and education tool on patient-physician discussion of behaviors and breast cancer risk.  Materials and Methods:  We conducted a randomized controlled trial with an ethnically and linguistically diverse sample of women, ages 40-74, from two primary care practices. Intervention participants completed a tablet computer-based Breast Cancer Risk Assessment and Education (BreastCARE) intervention in the waiting room before a scheduled visit. Both patients and physicians received an individualized risk report to discuss during the visit. Control patients underwent usual care. Telephone surveys assessed patient-physician discussion of weight, exercise, and alcohol use 1 week following the visit.  Results:  Among the 1235 participants, 27.7% (161/580) intervention and 22.3% (146/655) usual-care patients were high risk for breast cancer. Adjusting for clustering by physician, the intervention increased discussions of regular exercise (odds ratios [OR] = 1.94, 1.50-2.51) and weight (OR = 1.56, 1.23-1.96). There was no effect of the intervention on discussion of alcohol. Women with some college education were more likely to discuss their weight than those with high school education or less (OR = 1.75, 1.03-2.96). Similarly, non-English speakers were more likely to discuss their weight compared with English speakers (OR = 2.33, 1.04-5.22).  Conclusions:  BreastCARE is a feasible risk assessment tool that can successfully promote discussions about modifiable breast cancer risk factors between patients and primary care physicians.",2019,"Adjusting for clustering by physician, the intervention increased discussions of regular exercise (odds ratios [OR] = 1.94, 1.50-2.51) and weight (OR = 1.56, 1.23-1.96).","['Women with some college education', '1235 participants, 27.7% (161/580) intervention and 22.3% (146/655) usual-care patients were high risk for breast cancer', 'Breast Cancer', 'ethnically and linguistically diverse sample of women, ages 40-74, from two primary care practices']","['usual care', 'tablet computer-based Breast Cancer Risk Assessment and Education (BreastCARE) intervention']","['discussion of alcohol', 'discussions of regular exercise']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}]",1235.0,0.0158711,"Adjusting for clustering by physician, the intervention increased discussions of regular exercise (odds ratios [OR] = 1.94, 1.50-2.51) and weight (OR = 1.56, 1.23-1.96).","[{'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Ozanne', 'Affiliation': 'Division of Health System Innovation and Research, Department of Population Health Sciences, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Leah S', 'Initials': 'LS', 'LastName': 'Karliner', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Tice', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Livaudais-Toman', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Rena J', 'Initials': 'RJ', 'LastName': 'Pasick', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Celia P', 'Initials': 'CP', 'LastName': 'Kaplan', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, California.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7026']
1551,31727672,Study protocol: a randomised non-inferiority trial using interactive virtual presence to remotely assist parents with child restraint installations.,"BACKGROUND


Motor vehicle crashes are the third-leading cause of death to American children aged 1-5 years. When installed correctly, child restraints (car seats) reduce risk of serious injury and death. However, most restraints are installed incorrectly. The current gold standard for correct installation is systematic car seat checks, where certified technicians help parents, but car seat checks are highly underused due to barriers in access, scheduling and resources.
METHODS


The present study protocol describes plans to evaluate use of interactive virtual presence technology (interactive merged reality)-joint, simultaneous remote verbal and visual interaction and exposure to the same 3D stimuli-to assist remotely located parents installing child restraints. If effective, this technology could supplement or replace in-person checks and revolutionise how government, industry and non-profits help parents install child restraints properly. Building from preliminary studies, we propose a randomised non-inferiority trial to evaluate whether parents who install child restraints while communicating with remote expert technicians via interactive virtual presence on their smartphones achieve installations and learning not inferior in safety to parents who install restraints with on-site technicians. We will randomly assign 1476 caregivers at 7 US sites to install child restraints either via interactive virtual presence or live technicians. Correctness of installation will be assessed using objective checklists, both following installation and again 4 months later.
CONCLUSION


We aim to demonstrate that child restraint installation is accurate (>90% correct) when conducted remotely, that such installations are not inferior to installation accuracy with live experts and that parents learn and retain information about child restraint installation.",2020,"Building from preliminary studies, we propose a randomised non-inferiority trial to evaluate whether parents who install child restraints while communicating with remote expert technicians via interactive virtual presence on their smartphones achieve installations and learning not inferior in safety to parents who install restraints with on-site technicians.","['American children aged 1-5 years', 'parents with child restraint installations', '1476 caregivers at 7 US sites to install child restraints either via interactive virtual presence or live technicians', 'parents who install child restraints while communicating with remote expert technicians via interactive virtual presence on their smartphones achieve installations and learning not inferior in safety to parents who install restraints with on-site technicians']","['interactive virtual presence technology (interactive merged reality)-joint, simultaneous remote verbal and visual interaction and exposure to the same 3D stimuli-to assist remotely located parents installing child restraints']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0566001', 'cui_str': 'Does communicate (finding)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],1476.0,0.13722,"Building from preliminary studies, we propose a randomised non-inferiority trial to evaluate whether parents who install child restraints while communicating with remote expert technicians via interactive virtual presence on their smartphones achieve installations and learning not inferior in safety to parents who install restraints with on-site technicians.","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Schwebel', 'Affiliation': 'Psychology, University of Alabama at Birmingham, Birmingham, Alabama, USA schwebel@uab.edu.'}, {'ForeName': 'Jennifer Morag', 'Initials': 'JM', 'LastName': 'MacKay', 'Affiliation': 'Safe Kids Worldwide, Washington, District of Columbia, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Redden', 'Affiliation': 'Biostatistics, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2019-043463']
1552,31045851,A Cluster Randomized Controlled Trial to Evaluate HeadCoach: An Online Mental Health Training Program for Workplace Managers.,"OBJECTIVE


Mental ill-health is now the leading cause of sickness absence and occupational incapacity in high-income countries. This study evaluated HeadCoach online manager training, designed to improve confidence, and managerial behaviors that create mentally healthy workplaces.
METHODS


A cluster randomized controlled trial was conducted comparing managers who received HeadCoach (N = 87) to waitlist control (N = 123). Managers' confidence and behavior were investigated at baseline, postintervention, and follow-up. Psychological distress of direct reports was evaluated.
RESULTS


Confidence significantly increased postintervention only; however, per-protocol analyses indicated a significant improvement for program completers compared with control at both time points. Responsive and preventive behaviors significantly improved. Psychological distress of direct reports remained unchanged.
CONCLUSIONS


HeadCoach online mental health training is an effective and scalable way to improve managers' confidence and workplace practices around mental health. The impact on direct reports remains unknown.",2019,HeadCoach online mental health training is an effective and scalable way to improve managers' confidence and workplace practices around mental health.,"['N\u200a=\u200a87) to waitlist control (N\u200a=\u200a123', 'mentally healthy workplaces']","['HeadCoach online manager training', 'HeadCoach']",['Psychological distress'],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}]","[{'cui': 'C0335141', 'cui_str': 'Manager (occupation)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.102152,HeadCoach online mental health training is an effective and scalable way to improve managers' confidence and workplace practices around mental health.,"[{'ForeName': 'Aimée', 'Initials': 'A', 'LastName': 'Gayed', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, Australia (Ms Gayed and Dr Mykletun); Black Dog Institute, Faculty of Medicine, University of New South Wales, Sydney, Australia (Ms Bryan, Dr Deady, Dr Mackinnon, Dr Christensen, and Dr Harvey); Centre for Population Health Research, Deakin University, Geelong, Victoria, Australia (Dr LaMontagne); School of Population and Global Health, The University of Melbourne, Melbourne, Australia (Dr LaMontagne and Dr Milner); School of Electrical and Information Engineering, University of Sydney, Sydney, Australia (Dr Calvo); Centre for Mental Health, University of Melbourne, Melbourne, Australia (Dr Mackinnon); Department of Mental Health and Suicide, Norwegian Institute of Public Health, Oslo, Norway (Dr Mykletun); Department of Community Medicine, University of Tromsø, Tromsø, Norway (Dr Mykletun); Centre for Work and Mental Health, Nordland Hospital Trust, Bodø, Norway (Dr Mykletun); Centre for Research and Education in Forensic Psychiatry and Psychology, Haukeland University Hospital, Bergen, Norway (Dr Mykletun); and Brain and Mind Centre & Central Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, Australia (Dr Glozier).'}, {'ForeName': 'Bridget T', 'Initials': 'BT', 'LastName': 'Bryan', 'Affiliation': ''}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'LaMontagne', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Milner', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Deady', 'Affiliation': ''}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Calvo', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mackinnon', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': ''}, {'ForeName': 'Arnstein', 'Initials': 'A', 'LastName': 'Mykletun', 'Affiliation': ''}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Glozier', 'Affiliation': ''}, {'ForeName': 'Samuel B', 'Initials': 'SB', 'LastName': 'Harvey', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001597']
1553,31049551,Population pharmacokinetic meta-analysis of individual data to design the first randomized efficacy trial of vancomycin in neonates and young infants.,"OBJECTIVES


In the absence of consensus, the present meta-analysis was performed to determine an optimal dosing regimen of vancomycin for neonates.
METHODS


A 'meta-model' with 4894 concentrations from 1631 neonates was built using NONMEM, and Monte Carlo simulations were performed to design an optimal intermittent infusion, aiming to reach a target AUC0-24 of 400 mg·h/L at steady-state in at least 80% of neonates.
RESULTS


A two-compartment model best fitted the data. Current weight, postmenstrual age (PMA) and serum creatinine were the significant covariates for CL. After model validation, simulations showed that a loading dose (25 mg/kg) and a maintenance dose (15 mg/kg q12h if <35 weeks PMA and 15 mg/kg q8h if ≥35 weeks PMA) achieved the AUC0-24 target earlier than a standard 'Blue Book' dosage regimen in >89% of the treated patients.
CONCLUSIONS


The results of a population meta-analysis of vancomycin data have been used to develop a new dosing regimen for neonatal use and to assist in the design of the model-based, multinational European trial, NeoVanc.",2019,"mg/kg q8h if ≥35 weeks PMA) achieved the AUC0-24 target earlier than a standard 'Blue Book' dosage regimen in >89% of the treated patients.
","[""A 'meta-model' with 4894 concentrations from 1631 neonates"", 'neonates and young infants']",['vancomycin'],"['Current weight, postmenstrual age (PMA) and serum creatinine']","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}]","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}]",,0.0470818,"mg/kg q8h if ≥35 weeks PMA) achieved the AUC0-24 target earlier than a standard 'Blue Book' dosage regimen in >89% of the treated patients.
","[{'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Jacqz-Aigrain', 'Affiliation': 'Department of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Paris, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Leroux', 'Affiliation': 'Department of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Paris, France.'}, {'ForeName': 'Alison H', 'Initials': 'AH', 'LastName': 'Thomson', 'Affiliation': 'Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Allegaert', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'Pediatric Pharmacology and Drug Discovery, University of California, San Diego, CA, USA.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Biran', 'Affiliation': 'Neonatal Intensive Care Unit, Hôpital Robert Debré, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Simon', 'Affiliation': 'Department of Pharmacology, Hôpital de la Timone, APHM, Université de la Méditerranée, Marseille, France.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Meibohm', 'Affiliation': 'Department of Pharmaceutical Sciences, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Yoke-Lin', 'Initials': 'YL', 'LastName': 'Lo', 'Affiliation': 'Department of Pharmacy, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Remedios', 'Initials': 'R', 'LastName': 'Marques', 'Affiliation': 'Department of Pharmacy Services, La Fe Hospital, Valencia, Spain.'}, {'ForeName': 'José-Esteban', 'Initials': 'JE', 'LastName': 'Peris', 'Affiliation': 'Department of Pharmacy and Pharmaceutical Technology, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Irja', 'Initials': 'I', 'LastName': 'Lutsar', 'Affiliation': 'Institute of Medical Microbiology, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Jumpei', 'Initials': 'J', 'LastName': 'Saito', 'Affiliation': ""Department of Pharmacy, National Children's Hospital National Center for Child Health and Development, Tokyo, Japan.""}, {'ForeName': 'Hidefumi', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Department of Development Strategy, Center for Clinical Research and Development, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Johannes N', 'Initials': 'JN', 'LastName': 'van den Anker', 'Affiliation': 'Pharmacy Department, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Sharland', 'Affiliation': ""Paediatric Infectious Disease Unit, St George's Hospital, London, UK.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP, Paris, France.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz158']
1554,30987852,"Safety and immunogenicity of a respiratory syncytial virus fusion glycoprotein F subunit vaccine in healthy adults: Results of a phase 1, randomized, observer-blind, controlled, dosage-escalation study.","INTRODUCTION


Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory tract infections in infants. An investigational vaccine using an engineered recombinant RSV fusion glycoprotein in its post-fusion conformation (RSV F subunit vaccine) has been developed to protect young infants via maternal immunization. This first-in-human, phase I, observer-blind study (NCT02298179) evaluated the safety and immunogenicity of different dosages and formulations of RSV F subunit vaccine in healthy non-pregnant women and men aged 18-45 years.
METHODS


Participants were enrolled (1:1:1) in a stepwise dosage-escalation manner into three cohorts to receive RSV F subunit vaccine containing 45 µg, 90 µg and 135 μg of RSV F glycoprotein. Within each cohort, participants were randomized (1:1:1:1) to receive two doses of RSV F subunit vaccine with (aluminum hydroxide or MF59) or without adjuvant, or placebo, ≥28 days apart. Safety (until day 365 post-dose 2), anti-RSV neutralizing antibodies (NAbs) and serum total binding antibodies to RSV F protein (until day 181 post-dose 1) were evaluated.
RESULTS


All formulations were well-tolerated. No vaccine-related serious adverse events were reported. All participants were seropositive for anti-RSV NAbs at baseline, with geometric mean titers (GMTs) ranging from 184 (95% confidence interval [CI]: 127-266) to 380 (95% CI: 272-531). At 28 days post-dose 1, anti-RSV NAb GMTs in vaccine recipients ranged from 893 (95% CI: 702-1,136) to 1,602 (95% CI: 1,243-2,064). No booster effect was observed, but immune responses were maintained above pre-vaccination levels for six months post-dose 1. Ratios of RSV F total binding antibodies fold changes to NAb fold changes ranged from 2.79 to 4.12 at 28 days post-dose 1. The impact of the adjuvant was limited.
CONCLUSIONS


A single dose of each formulation of RSV subunit F vaccine was well-tolerated and enhanced preexisting NAb titers through six months of follow-up.",2019,A single dose of each formulation of RSV subunit F vaccine was well-tolerated and enhanced preexisting NAb titers through six months of follow-up.,"['healthy non-pregnant women and men aged 18-45\u202fyears', 'infants', 'Participants were enrolled (1:1:1) in a stepwise dosage-escalation manner into three cohorts to receive', 'young infants via maternal immunization', 'healthy adults']","['RSV F subunit vaccine with (aluminum hydroxide or MF59) or without adjuvant, or placebo', 'RSV F subunit vaccine containing 45\u202fµg, 90\u202fµg and 135\u202fμg of RSV F glycoprotein', 'RSV subunit F vaccine', 'respiratory syncytial virus fusion glycoprotein F subunit vaccine', 'RSV F subunit vaccine']","['Safety and immunogenicity', 'safety and immunogenicity', 'anti-RSV neutralizing antibodies (NAbs) and serum total binding antibodies to RSV F protein', 'tolerated']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0887892', 'cui_str': 'Vaccines, Subunit'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}, {'cui': 'C0289787', 'cui_str': 'MF59'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",,0.411656,A single dose of each formulation of RSV subunit F vaccine was well-tolerated and enhanced preexisting NAb titers through six months of follow-up.,"[{'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Leroux-Roels', 'Affiliation': 'Centre for Vaccinology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium. Electronic address: Geert.LerouxRoels@UGent.be.'}, {'ForeName': 'Fien', 'Initials': 'F', 'LastName': 'De Boever', 'Affiliation': 'Centre for Vaccinology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium. Electronic address: Fien.DeBoever@uzgent.be.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Maes', 'Affiliation': 'Centre for Vaccinology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium. Electronic address: Cathy.Maes@uzgent.be.'}, {'ForeName': 'Thi Lien-Anh', 'Initials': 'TL', 'LastName': 'Nguyen', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium.'}, {'ForeName': 'Sherryl', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'GSK, 14200 Shady Grove Rd, Rockville, MD 20850, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gonzalez Lopez', 'Affiliation': 'GSK, 14200 Shady Grove Rd, Rockville, MD 20850, USA. Electronic address: antonio.y.gonzalez@gsk.com.'}]",Vaccine,['10.1016/j.vaccine.2019.04.011']
1555,31031072,Predicting Failure of Intravenous Access in Adults: The Value of Prior Difficulty.,"BACKGROUND


When intravenous access cannot be established using traditional methods of inspection/palpation, advanced methods are often required, leading to substantial delays in care. Knowing the likelihood of intravenous access failure can improve emergency department (ED) efficiency.
OBJECTIVE


Our aim was to validate prior need for an advanced technique to establish intravenous access as a predictor of failure to achieve access via traditional methods and to estimate the risk difference associated with this finding.
METHODS


We re-analyzed data collected for a clinical trial that randomized ED patients requiring intravenous access to one of two types of intravenous catheter; gauge size was selected by the inserter. The re-analysis pools data from both groups to examine predictors of failure to establish intravenous access by traditional methods, with failure defined as abandonment or use of an advanced technique (ultrasound guidance or external jugular vein catheterization). Confidence intervals for the difference between proportions were calculated using a normal binomial approximation.
RESULTS


We obtained data from 600 patients, with a median age of 52 years (interquartile range 36-63 years). We noted failure of traditional methods in 28 (4.7%) patients, including 17 of 109 (16%) with prior need for advanced techniques. The risk difference for prior need for advanced techniques versus no prior difficulty was 14% (95% confidence interval 7-22).
CONCLUSIONS


Patients with a prior need for advanced techniques were 14% more likely to have failure of intravenous access by traditional methods than those without prior difficulty.",2019,"CONCLUSIONS


Patients with a prior need for advanced techniques were 14% more likely to have failure of intravenous access by traditional methods than those without prior difficulty.","['Adults', '600 patients, with a median age of 52\xa0years (interquartile range 36-63\xa0years', '28 (4.7%) patients, including 17 of 109 (16%) with prior need for advanced techniques']",['advanced technique (ultrasound guidance or external jugular vein catheterization'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C0226543', 'cui_str': 'Structure of external jugular vein'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]",[],600.0,0.158002,"CONCLUSIONS


Patients with a prior need for advanced techniques were 14% more likely to have failure of intravenous access by traditional methods than those without prior difficulty.","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Witting', 'Affiliation': 'Department of Emergency Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Moayedi', 'Affiliation': 'Department of Emergency Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jon Mark', 'Initials': 'JM', 'LastName': 'Hirshon', 'Affiliation': 'Department of Emergency Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Nicholas H', 'Initials': 'NH', 'LastName': 'George', 'Affiliation': 'Department of Emergency Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Schenkel', 'Affiliation': 'Department of Emergency Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2019.02.011']
1556,31021713,Effects of Hormone Therapy on List and Story Recall in Post-Menopausal Women.,"Background/Study Context: A number of longitudinal randomized controlled trials (LRCT) have used free verbal recall tests to study the effects of post-menopausal estrogen hormone therapy (HT) on episodic memory, but none have explicitly explored contrasts between list and story recall, in spite of cognitive differences between the tasks. For example, list recall provides little support for the use of gist, while story recall emphasizes it, and there is evidence that estrogen produces gist bias. Moreover, we present a literature tabulation that also suggests a task-specific HT effect.
METHODS


In an LRCT with up to eight yearly test sessions, post-menopausal women were randomly assigned either to placebo (N = 56) or to an estrogen formulation (N = 44); subgroups received either estrogen alone (hysterectomy; E-alone; N = 16) or with progestin (intact uterus; E + P; N = 28). Participants were tested on the immediate and delayed list and story recall at each session.
RESULTS


Linear mixed effects analyses of longitudinal trajectories showed that relative to placebo, the HT group declined significantly faster on immediate list recall and slower on immediate story recall. Separate analyses produced a sharpened version of this pattern for the E-alone subgroup but found no significant effects for the E + P subgroup. No significant effects were found in delayed testing.
CONCLUSION


The dissociation we found for immediate list and story recall is similar to the pattern of results in our literature tabulation. Fuzzy-Trace Theory posits parallel verbatim and gist traces plus a meta-cognitive review which becomes more gist-biased with age. Our results suggest that: (1) estrogen increases gist bias, hastening the normal age-related decline of list recall but slowing the decline of story recall relative to placebo; (2) decay of the verbatim trace over time generally causes a shift to gist, thereby accounting for the absence of a delayed recall difference; and (3) progestin weakens the effects of estrogen, thereby accounting for why the dissociation found in E-alone was absent in the E + P subgroup.",2019,"RESULTS


Linear mixed effects analyses of longitudinal trajectories showed that relative to placebo, the HT group declined significantly faster on immediate list recall and slower on immediate story recall.","['post-menopausal women', 'Post-Menopausal Women']","['LRCT', 'placebo', 'Hormone Therapy', 'estrogen alone (hysterectomy; E-alone; N = 16) or with progestin', 'estrogen formulation', 'menopausal estrogen hormone therapy (HT']","['immediate list recall and slower on immediate story recall', 'immediate and delayed list and story recall', 'List and Story Recall', 'delayed testing']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0474186', 'cui_str': 'Estrogen hormone therapy (procedure)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.121856,"RESULTS


Linear mixed effects analyses of longitudinal trajectories showed that relative to placebo, the HT group declined significantly faster on immediate list recall and slower on immediate story recall.","[{'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Ober', 'Affiliation': 'a Human Development and Family Studies, Department of Human Ecology , University of California , Davis , USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Shenaut', 'Affiliation': 'a Human Development and Family Studies, Department of Human Ecology , University of California , Davis , USA.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Taylor', 'Affiliation': 'b Department of Public Health Sciences, School of Medicine , University of California , Davis , USA.'}]",Experimental aging research,['10.1080/0361073X.2019.1609169']
1557,30901609,Randomised phase II trial comparing four front-line doublets in Asian patients with metastatic gastric cancer.,"INTRODUCTION


Consensus has not been reached regarding the standard regimen for front-line chemotherapy of recurrent/metastatic gastric cancer. In this randomised phase II study, we compared four doublet regimens: S-1 and cisplatin (SP); oxaliplatin and 5-FU (FOLFOX); docetaxel and 5-FU (DF) and paclitaxel and 5-FU (PF).
PATIENTS AND METHODS


Patients without prior history of chemotherapy for recurrent/metastatic gastric cancer were randomised evenly to each regimen. The primary end-point was progression-free survival (PFS). The secondary end-points were overall survival (OS), response rate (RR) and safety profile.
RESULTS


A total of 179 Korean patients were enrolled from March 2010 to May 2015. The study was prematurely terminated because of slow accrual. At data cut-off, the median PFS was 8.4 months for SP, 5.8 months for FOLFOX, 5.7 months for DF and 4.2 months for PF (P = 0.023). The median OS was 14.7 months for SP, 11.3 months for FOLFOX, 11.7 months for DF and 10.8 months for PF (P = 0.143). RR was 18%, 23%, 16% and 32% for SP, FOLFOX, DF and PF, respectively. The platinum group displayed a longer PFS trend than the taxane group (7.2 versus 4.9 months, P = 0.058), but no significant difference in OS was found. Notably, 105 patients were exposed to all three drugs (platinum, taxane and fluoropyrimidine) throughout the treatment course, and OS was identical whether starting with platinum or taxane (13.3 versus 13.3 months, P = 0.997). All regimens were well tolerated.
CONCLUSION


SP showed the most favourable results in PFS, whereas a significant difference in OS was not observed among the four regimens.",2019,"RR was 18%, 23%, 16% and 32% for SP, FOLFOX, DF and PF, respectively.","['Patients without prior history of chemotherapy for recurrent/metastatic gastric cancer', '179 Korean patients were enrolled from March 2010 to May 2015', 'Asian patients with metastatic gastric cancer', '105 patients were exposed to all three']","['taxane', 'drugs (platinum, taxane\xa0and fluoropyrimidine', 'FOLFOX', 'S-1 and cisplatin (SP); oxaliplatin and 5-FU (FOLFOX); docetaxel and 5-FU (DF)\xa0and paclitaxel and 5-FU (PF', 'platinum or taxane']","['progression-free survival (PFS', 'tolerated', 'OS', 'overall survival (OS), response rate (RR)\xa0and safety profile', 'longer PFS', 'median OS', 'RR', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0455632', 'cui_str': 'H/O: chemotherapy'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0278498', 'cui_str': 'Metastatic gastric cancer'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",179.0,0.0169133,"RR was 18%, 23%, 16% and 32% for SP, FOLFOX, DF and PF, respectively.","[{'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'Medical Oncology, CHA Bundang Medical Center, CHA University, Seongnam, South Korea.'}, {'ForeName': 'Hong Jae', 'Initials': 'HJ', 'LastName': 'Chon', 'Affiliation': 'Medical Oncology, CHA Bundang Medical Center, CHA University, Seongnam, South Korea.'}, {'ForeName': 'Joo Hoon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Medical Oncology, CHA Bundang Medical Center, CHA University, Seongnam, South Korea.'}, {'ForeName': 'Minkyu', 'Initials': 'M', 'LastName': 'Jung', 'Affiliation': 'Department of Medical Oncology, Yonsei Cancer Center, Yonsei University Health System, South Korea.'}, {'ForeName': 'Chung Mo', 'Initials': 'CM', 'LastName': 'Nam', 'Affiliation': 'Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyo Song', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Medical Oncology, Yonsei Cancer Center, Yonsei University Health System, South Korea.'}, {'ForeName': 'Beodeul', 'Initials': 'B', 'LastName': 'Kang', 'Affiliation': 'Department of Medical Oncology, Yonsei Cancer Center, Yonsei University Health System, South Korea.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'Department of Medical Oncology, Yonsei Cancer Center, Yonsei University Health System, South Korea; Songdang Institute for Cancer Research, Yonsei University College of Medicine, Seoul, South Korea; Brain Korea 21 PLUS Project for Medical Science, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Rha', 'Affiliation': 'Department of Medical Oncology, Yonsei Cancer Center, Yonsei University Health System, South Korea; Songdang Institute for Cancer Research, Yonsei University College of Medicine, Seoul, South Korea; Brain Korea 21 PLUS Project for Medical Science, Yonsei University College of Medicine, Seoul, South Korea. Electronic address: rha7655@yuhs.ac.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2018.11.029']
1558,32410697,Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial.,"BACKGROUND


Anterior cruciate ligament (ACL) rupture is a common knee injury that can lead to poor quality of life, decreased activity and increased risk of secondary osteoarthritis of the knee. Management of patients with a non-acute ACL injury can include a non-surgical (rehabilitation) or surgical (reconstruction) approach. However, insufficient evidence to guide treatment selection has led to high variation in treatment choice for patients with non-acute presentation of ACL injury. The objective of the ACL SNNAP trial is to determine in patients with non-acute anterior cruciate ligament deficiency (ACLD) whether a strategy of non-surgical management (rehabilitation) (with option for later ACL reconstruction only if required) is more clinically effective and cost effective than a strategy of surgical management (reconstruction) without prior rehabilitation with all patients followed up at 18 months.
METHODS


The study is a pragmatic, multi-centre, superiority, randomised controlled trial with two-arm parallel groups and 1:1 allocation. Patients with a symptomatic non-acute ACL deficient knee will be randomised to either non-surgical management (rehabilitation) or surgical management (reconstruction). We aim to recruit 320 patients from approximately 30 secondary care orthopaedic units from across the United Kingdom. Randomisation will occur using a web-based randomisation system. Blinding of patients and clinicians to treatment allocation will not be possible because of the nature of the interventions. Participants will be followed up via self-reported questionnaires at 6, 12 and 18 months. The primary outcome is the Knee injury and Osteoarthritis Outcome Score (KOOS) at 18 months post randomisation. Secondary outcomes will include a return to sport/activity, intervention-related complications, patient satisfaction, expectations of activity, generic health quality of life, knee specific quality of life and resource usage.
DISCUSSION


At present, no evidence-based treatment of non-acute ACL deficiency exists, particularly in the NHS. Moreover, little consensus exists on the management approach for these patients. The proposed trial will address this gap in knowledge regarding the clinical and cost effectiveness of ACL treatment and inform future standards of care for this condition.
TRIAL REGISTRATION


ISRCTN: 10110685. Registered on 16 November 2016. ClinicalTrials.gov: NCT02980367. Registered in December 2016.",2020,"Secondary outcomes will include a return to sport/activity, intervention-related complications, patient satisfaction, expectations of activity, generic health quality of life, knee specific quality of life and resource usage.
","['Anterior cruciate ligament (ACL) rupture', '320 patients from approximately 30 secondary care orthopaedic units from across the United Kingdom', 'patients with a non-acute ACL injury can include a non-surgical (rehabilitation) or surgical (reconstruction) approach', 'non-acute anterior cruciate ligament', 'ACL) injury', 'patients with non-acute anterior cruciate ligament deficiency (ACLD', 'Patients with a symptomatic non-acute ACL deficient knee', 'patients with non-acute presentation of ACL injury']","['ACL SNNAP', 'non-surgical management (rehabilitation) or surgical management (reconstruction', 'management strategies (rehabilitation versus surgical reconstruction']","['Knee injury and Osteoarthritis Outcome Score (KOOS', 'return to sport/activity, intervention-related complications, patient satisfaction, expectations of activity, generic health quality of life, knee specific quality of life and resource usage']","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449446', 'cui_str': 'Surgical approach'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0457083', 'cui_str': 'Usage'}]",,0.109903,"Secondary outcomes will include a return to sport/activity, intervention-related complications, patient satisfaction, expectations of activity, generic health quality of life, knee specific quality of life and resource usage.
","[{'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Davies', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK. loretta.davies@ndorms.ox.ac.uk.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Department of Public Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Carlos Morgado', 'Initials': 'CM', 'LastName': 'Areia', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Shirkey', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Jackson', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Department of Public Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Fletcher', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Carr', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Barker', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monk', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': ""O'Leary"", 'Affiliation': 'Royal Berkshire NHS Foundation Trust, Reading, UK.'}, {'ForeName': 'Fares', 'Initials': 'F', 'LastName': 'Haddad', 'Affiliation': 'University College Hospital, London, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': 'University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Price', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, OX3 7LD, UK.'}]",Trials,['10.1186/s13063-020-04298-y']
1559,31040096,"Antimicrobial-impregnated central venous catheters for prevention of neonatal bloodstream infection (PREVAIL): an open-label, parallel-group, pragmatic, randomised controlled trial.","BACKGROUND


Bloodstream infection is associated with high mortality and serious morbidity in preterm babies. Evidence from clinical trials shows that antimicrobial-impregnated central venous catheters (CVCs) reduce catheter-related bloodstream infection in adults and children receiving intensive care, but there is a paucity of similar evidence for babies receiving neonatal intensive care.
METHODS


This open-label, parallel-group, pragmatic, randomised controlled trial was done in 18 neonatal intensive care units in England. Newborn babies who needed a peripherally inserted CVC (PICC) were allocated randomly (1:1) to receive either a PICC impregnated with miconazole and rifampicin or a standard (non-antimicrobial-impregnated) PICC. Random allocation was done with a web-based program, which was centrally controlled to ensure allocation concealment. Randomisation sequences were computer-generated in random blocks of two and four, and stratified by site. Masking of clinicians to PICC allocation was impractical because rifampicin caused brown staining of the antimicrobial-impregnated PICC. However, participant inclusion in analyses and occurrence of outcome events were determined following an analysis plan that was specified before individuals saw the unblinded data. The primary outcome was the time from random allocation to first microbiologically confirmed bloodstream or cerebrospinal fluid (CSF) infection between 24 h after randomisation and 48 h after PICC removal or death. We analysed outcome data according to the intention-to-treat principle. We excluded babies for whom a PICC was not inserted from safety analyses, as these analyses were done with groups defined by the PICC used. This trial is registered with ISRCTN, number 81931394.
FINDINGS


Between Aug 12, 2015, and Jan 11, 2017, we randomly assigned 861 babies (754 [88%] born before 32 weeks of gestation) to receive an antimicrobial-impregnated PICC (430 babies) or standard PICC (431 babies). The median time to PICC removal was 8·20 days (IQR 4·77-12·13) in the antimicrobial-impregnated PICC group versus 7·86 days (5·00-12·53) days in the standard PICC group (hazard ratio [HR] 1·03, 95% CI 0·89-1·18, p=0·73), with 46 (11%) of 430 babies versus 44 (10%) of 431 babies having a microbiologically confirmed bloodstream or CSF infection. The time from random allocation to first bloodstream or CSF infection was similar between the two groups (HR 1·11, 95% CI 0·73-1·67, p=0·63). Secondary outcomes relating to infection, rifampicin resistance in positive blood or CSF cultures, mortality, clinical outcomes at neonatal unit discharge, and time to PICC removal were similar between the two groups, although rifampicin resistance in positive cultures of PICC tips was higher in the antimicrobial-impregnated PICC group (relative risk 3·51, 95% CI 1·16-10·57, p=0·018). 60 adverse events were reported from 49 (13%) patients in the antimicrobial-impregnated PICC group and 50 events from 45 (10%) babies in the standard PICC group.
INTERPRETATION


We found no evidence of benefit or harm associated with miconazole and rifampicin-impregnated PICCs compared with standard PICCs for newborn babies. Future research should focus on other types of antimicrobial impregnation of PICCs and alternative approaches for preventing infection.
FUNDING


UK National Institute for Health Research Health Technology Assessment programme.",2019,"The time from random allocation to first bloodstream or CSF infection was similar between the two groups (HR 1·11, 95% CI 0·73-1·67, p=0·63).","['Between Aug 12, 2015, and Jan 11, 2017', 'preterm babies', 'Newborn babies who needed a peripherally inserted CVC (PICC', 'adults and children receiving intensive care', '18 neonatal intensive care units in England', 'babies receiving neonatal intensive care', 'newborn babies']","['miconazole and rifampicin-impregnated PICCs', 'antimicrobial-impregnated PICC (430 babies) or standard PICC', 'Antimicrobial-impregnated central venous catheters', 'PICC impregnated with miconazole and rifampicin or a standard (non-antimicrobial-impregnated) PICC', 'antimicrobial-impregnated central venous catheters (CVCs']","['median time to PICC removal', 'infection, rifampicin resistance in positive blood or CSF cultures, mortality, clinical outcomes at neonatal unit discharge, and time to PICC removal', 'rifampicin resistance in positive cultures of PICC tips', '60 adverse events', 'time from random allocation to first microbiologically confirmed bloodstream or cerebrospinal fluid (CSF) infection', 'bloodstream or CSF infection', 'time from random allocation to first bloodstream or CSF infection']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085559'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0021711', 'cui_str': 'Infant, Newborn, Intensive Care'}]","[{'cui': 'C0025942', 'cui_str': 'Miconazole'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1145640', 'cui_str': 'Central Venous Catheters'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0430403', 'cui_str': 'Cerebrospinal fluid culture (procedure)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0007807'}]",,0.184959,"The time from random allocation to first bloodstream or CSF infection was similar between the two groups (HR 1·11, 95% CI 0·73-1·67, p=0·63).","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Gilbert', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK; Health Data Research UK, London, UK. Electronic address: r.gilbert@ucl.ac.uk.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Rainford', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Donohue', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fraser', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Sinha', 'Affiliation': 'Barts Health NHS Trust, London, UK; Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Dorling', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Dalhousie University IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Gray', 'Affiliation': ""Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'McGuire', 'Affiliation': 'Centre for Reviews and Dissemination, University of York, York, UK.'}, {'ForeName': 'Carrol', 'Initials': 'C', 'LastName': 'Gamble', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Oddie', 'Affiliation': 'Centre for Reviews and Dissemination, University of York, York, UK; Bradford Institute for Health Research, Bradford Royal Infirmary, Bradford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(19)30114-2']
1560,31034588,Feasibility of an Intervention to Support Hearing and Vision in Dementia: The SENSE-Cog Field Trial.,"OBJECTIVES


People with dementia (PwD) frequently experience hearing and vision impairment that is underrecognized and undertreated, resulting in reduced quality of life. Managing these impairments may be an important strategy to improve outcomes in PwD. Our objective was to field-trial a multifaceted sensory intervention (SI) to enhance hearing and vision in PwD.
DESIGN


An international single-arm open-label feasibility, acceptability, and tolerability study.
SETTING


Home-based setting in the United Kingdom, France, and Cyprus.
PARTICIPANTS


Adults aged 60 years and older with mild-to-moderate dementia and uncorrected or suboptimally corrected hearing and/or vision impairment, and their study partners (n = 19 dyads).
INTERVENTION


A sensory intervention (SI), comprising assessment of hearing and vision, fitting of corrective devices (glasses, hearing aids), and home-based support from a sensory support therapist for device adherence and maintenance, communication training, referral to support services, environmental sensory modification, and optimization of social inclusion.
MEASUREMENTS


Ratings of study procedure feasibility, and intervention acceptability/tolerability, ascertained through questionnaires, participant diaries, therapist logbooks, and semistructured interviews.
RESULTS


We successfully delivered all intervention components, and these were received and enacted as intended in all those who completed the intervention. No serious adverse events were reported. Acceptability (ie, understanding, motivation, sense of achievement) and tolerability (ie, effort, fatigue) ratings of the intervention were within a priori target ranges. We met recruitment and retention (93.8%) targets in two of the three sites. Participants completed more than 95% of diary entries, representing minimal missing data. Delays in the logistics circuit for the assessment and delivery of hearing aids and glasses were identified, requiring modification. The need for minor modifications to some outcome measures and the inclusion criteria were identified.
CONCLUSION


This is the first study combining home-based hearing and vision remediation in PwD. The positive feasibility, acceptability, and tolerability findings suggest that a full-scale efficacy trial, with certain modifications, is achievable.",2019,No serious adverse events were reported.,"['People with dementia (PwD', 'Adults aged 60 years and older with mild-to-moderate dementia and uncorrected or suboptimally corrected hearing and/or vision impairment, and their study partners (n\u2009=\u200919 dyads', 'Dementia', 'Home-based setting in the United Kingdom, France, and Cyprus']","['sensory intervention (SI), comprising assessment of hearing and vision, fitting of corrective devices (glasses, hearing aids), and home-based support from a sensory support therapist', 'Intervention to Support Hearing and Vision', 'multifaceted sensory intervention (SI']","['Acceptability', 'Ratings of study procedure feasibility, and intervention acceptability/tolerability, ascertained through questionnaires, participant diaries, therapist logbooks, and semistructured interviews', 'positive feasibility, acceptability, and tolerability', ' understanding, motivation, sense of achievement) and tolerability (ie, effort, fatigue) ratings', 'serious adverse events']","[{'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0010622', 'cui_str': 'Cyprus'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0503869,No serious adverse events were reported.,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hooper', 'Affiliation': 'Faculty of Biology, Medicine and Health, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Simkin', 'Affiliation': 'Faculty of Biology, Medicine and Health, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Abrams', 'Affiliation': 'University of South Florida, Tampa, Florida.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Camacho', 'Affiliation': 'Manchester Centre for Health Economics, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Anna Pavlina', 'Initials': 'AP', 'LastName': 'Charalambous', 'Affiliation': 'Department of Health Sciences, School of Sciences, European University Cyprus, Nicosia, Cyprus.'}, {'ForeName': 'Fideline', 'Initials': 'F', 'LastName': 'Collin', 'Affiliation': 'INSERM, EUCLID/F-CRIN Clinical Trials Platform, Bordeaux Population Health Center, CHU Bordeaux, F-33000, University of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Fofi', 'Initials': 'F', 'LastName': 'Constantinidou', 'Affiliation': 'Department of Psychology and Center for Applied Neuroscience, University of Cyprus, Nicosia, Cyprus.'}, {'ForeName': 'Piers', 'Initials': 'P', 'LastName': 'Dawes', 'Affiliation': 'Manchester Centre for Audiology and Deafness, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Elliott', 'Affiliation': 'Manchester Centre for Health Economics, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Falkingham', 'Affiliation': 'Starkey Hearing Technologies, Stockport, United Kingdom.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Frison', 'Affiliation': 'INSERM, EUCLID/F-CRIN Clinical Trials Platform, Bordeaux Population Health Center, CHU Bordeaux, F-33000, University of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hann', 'Affiliation': 'Centre for Biostatistics, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Helmer', 'Affiliation': 'INSERM, Bordeaux Population Health Research Center, Team LEHA, University of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Himmelsbach', 'Affiliation': 'Catholic University of Applied Sciences Freiburg, Freiburg, Germany.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Hussain', 'Affiliation': 'Manchester Centre for Health Economics, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Marié', 'Affiliation': 'Essilor International, Research & Development, Paris, France.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Montecelo', 'Affiliation': 'Essilor International, Research & Development, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reeves', 'Affiliation': 'Centre for Biostatistics, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Regan', 'Affiliation': 'University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Chryssoula', 'Initials': 'C', 'LastName': 'Thodi', 'Affiliation': 'Department of Health Sciences, School of Sciences, European University Cyprus, Nicosia, Cyprus.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Wolski', 'Affiliation': 'Catholic University of Applied Sciences Freiburg, Freiburg, Germany.'}, {'ForeName': 'Iracema', 'Initials': 'I', 'LastName': 'Leroi', 'Affiliation': 'Faculty of Biology, Medicine and Health, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15936']
1561,31035784,The Effect of Nitrous Oxide on the Outcomes of Underlay Tympanoplasty: A Prospective Study.,"The main aims of tympanoplasty are eradication of chronic middle ear disease, repair of the tympanic membrane, and restoration of hearing. Nitrous oxide (N 2 O) is not a commonly preferred anesthetic agent for tympanoplasty because this agent may increase middle ear pressure and displace the graft. In this study, we researched the surgical outcomes of the underlay tympanoplasty performed with N 2 O anesthesia. Patients who underwent tympanoplasty were included in this prospective study. A type 1 tympanoplasty was performed in all patients using the underlay technique. Patients were randomized to groups that did and did not receive N 2 O. Preoperative and postoperative hearing thresholds were evaluated, postoperative pain scores were recorded, and the differences between the groups were statistically evaluated. There were 44 patients who received N 2 O and 44 who did not. The graft success rate was 93.2% in the N 2 O-receiving group and 84.1% in the nonreceiving group ( P  > .05). Hearing levels improved significantly after surgery in each group ( P  < .05), but the difference between the groups was not significant ( P  > .05). The postoperative pain score was 3.72 ± 1.3 in the N 2 O-receiving group and 4.45 ± 2.3 in the nonreceiving group ( P  > .05). Nitrous oxide is a cheap, safe, and readily available anesthetic agent that provides acceptable success rates in patients undergoing tympanoplasty.",2019,"Hearing levels improved significantly after surgery in each group ( P < .05), but the difference between the groups was not significant ( P > .05).","['Patients who underwent tympanoplasty', '44 patients who received N 2 O and 44 who did not', 'Underlay Tympanoplasty', 'patients undergoing tympanoplasty']","['Nitrous Oxide', 'Nitrous oxide (N 2 O', 'underlay tympanoplasty performed with N 2 O anesthesia', 'Nitrous oxide']","['Hearing levels', 'graft success rate', 'postoperative pain scores', 'postoperative pain score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041447', 'cui_str': 'Tympanoplasty'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0444455', 'cui_str': 'Underlay (qualifier value)'}]","[{'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0444455', 'cui_str': 'Underlay (qualifier value)'}, {'cui': 'C0041447', 'cui_str': 'Tympanoplasty'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",44.0,0.0351205,"Hearing levels improved significantly after surgery in each group ( P < .05), but the difference between the groups was not significant ( P > .05).","[{'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Düzenli', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Nazım', 'Initials': 'N', 'LastName': 'Bozan', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Mahfuz', 'Initials': 'M', 'LastName': 'Turan', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Ağırbaş', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Arzu Esen', 'Initials': 'AE', 'LastName': 'Tekeli', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Ahmet Faruk', 'Initials': 'AF', 'LastName': 'Kıroğlu', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Yüzüncü Yıl University, Van, Turkey.'}]","Ear, nose, & throat journal",['10.1177/0145561319846460']
1562,30928806,Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial.,"INTRODUCTION


The objective of this study was to evaluate the efficacy and safety of eribulin monotherapy, relative to vinorelbine, in Chinese women with locally recurrent/metastatic breast cancer (MBC).
METHODS


This phase III open-label, randomised, parallel-group, multicentre clinical trial enrolled patients with locally recurrent or MBC who had had 2-5 prior chemotherapy regimens, including an anthracycline and taxane) from September 26, 2013, to May 19, 2015. Women were randomised 1:1 to receive eribulin (1.4 mg/m 2 , intravenously, on day 1 and day 8) or vinorelbine (25 mg/m 2 , intravenously, on day 1, day 8 and day 15) every 21 days. The primary end-point was progression-free survival (PFS). Secondary end-points included objective response rate (ORR), duration of response and overall survival (OS).
RESULTS


Five hundred thirty women were randomised to receive eribulin (n = 264) or vinorelbine (n = 266). Improvement in PFS was observed with eribulin compared with vinorelbine (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.65-0.98, P = 0.036); median PFS was 2.8 months in both treatment arms. The median OS was 13.4 months with eribulin and 12.5 months with vinorelbine (HR: 1.03, 95% CI: 0.80-1.31, P = 0.838). The ORR was 30.7% (95% CI: 25.2%-36.6%) with eribulin and 16.9% (95% CI: 12.6%-22.0%) with vinorelbine (P < 0.001). Treatment-emergent adverse events leading to treatment discontinuation were less frequent with eribulin (7.2%) than with vinorelbine (14.0%).
CONCLUSIONS


Eribulin achieved statistically significantly superior PFS (and response rate) compared with vinorelbine in previously treated women with locally recurrent or MBC. Eribulin appeared to be better tolerated than vinorelbine, with no new safety signals observed.
TRIAL REGISTRATION


National Institutes of Health ClinicalTrials.gov registry, NCT02225470. Registered 05 August 2014- Retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT02225470?term=NCT02225470&rank=1.",2019,The ORR was 30.7% (95% CI: 25.2%-36.6%) with eribulin and 16.9% (95% CI: 12.6%-22.0%) with vinorelbine (P < 0.001).,"['August 2014', 'Five hundred thirty women', 'Chinese women with locally recurrent/metastatic breast cancer (MBC', 'previously treated women with locally recurrent or MBC', 'women with locally recurrent or metastatic breast cancer', 'patients with locally recurrent or MBC who had had 2-5 prior chemotherapy regimens, including an anthracycline and taxane) from September 26, 2013, to May 19, 2015']","['vinorelbine', 'eribulin', 'eribulin monotherapy, relative to vinorelbine', 'Eribulin mesilate']","['objective response rate (ORR), duration of response\xa0and overall survival (OS', 'progression-free survival (PFS', 'median OS', 'PFS', 'superior PFS (and response rate', 'efficacy and safety', 'ORR', 'median PFS']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C2350866', 'cui_str': 'eribulin'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C2608038', 'cui_str': 'eribulin mesylate'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",530.0,0.272818,The ORR was 30.7% (95% CI: 25.2%-36.6%) with eribulin and 16.9% (95% CI: 12.6%-22.0%) with vinorelbine (P < 0.001).,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Xichun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Cancer Center, The First Hospital of Jilin University, Changchun City, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, The Third Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Shude', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Department of Breast Surgery, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Thoracic Oncology, Jilin Province Tumor Hospital, Changchun, China.'}, {'ForeName': 'Quchang', 'Initials': 'Q', 'LastName': 'Ouyang', 'Affiliation': 'Oncology Division of Breast Cancer, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Xiaojia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, The Second Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Hiraiwa', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Setsuo', 'Initials': 'S', 'LastName': 'Funasaka', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China. Electronic address: bhxu@hotmail.com.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.02.002']
1563,30545967,Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial.,"OBJECTIVE


To determine if using a parachute prevents death or major traumatic injury when jumping from an aircraft.
DESIGN


Randomized controlled trial.
SETTING


Private or commercial aircraft between September 2017 and August 2018.
PARTICIPANTS


92 aircraft passengers aged 18 and over were screened for participation. 23 agreed to be enrolled and were randomized.
INTERVENTION


Jumping from an aircraft (airplane or helicopter) with a parachute versus an empty backpack (unblinded).
MAIN OUTCOME MEASURES


Composite of death or major traumatic injury (defined by an Injury Severity Score over 15) upon impact with the ground measured immediately after landing.
RESULTS


Parachute use did not significantly reduce death or major injury (0% for parachute  v  0% for control; P>0.9). This finding was consistent across multiple subgroups. Compared with individuals screened but not enrolled, participants included in the study were on aircraft at significantly lower altitude (mean of 0.6 m for participants  v  mean of 9146 m for non-participants; P<0.001) and lower velocity (mean of 0 km/h  v  mean of 800 km/h; P<0.001).
CONCLUSIONS


Parachute use did not reduce death or major traumatic injury when jumping from aircraft in the first randomized evaluation of this intervention. However, the trial was only able to enroll participants on small stationary aircraft on the ground, suggesting cautious extrapolation to high altitude jumps. When beliefs regarding the effectiveness of an intervention exist in the community, randomized trials might selectively enroll individuals with a lower perceived likelihood of benefit, thus diminishing the applicability of the results to clinical practice.",2018,"RESULTS


Parachute use did not significantly reduce death or major injury (0% for parachute  v  0% for control; P>0.9).","['23 agreed to be enrolled and were randomized', '92 aircraft passengers aged 18 and over were screened for participation', 'Private or commercial aircraft between September 2017 and August 2018', 'Jumping from an aircraft (airplane or helicopter) with a parachute versus an empty backpack (unblinded']",[],"['death and major trauma', 'Composite of death or major traumatic injury (defined by an Injury Severity Score over 15) upon impact with the ground measured immediately after landing', 'death or major injury', 'death or major traumatic injury']","[{'cui': 'C0001881', 'cui_str': 'Aircraft'}, {'cui': 'C0450048', 'cui_str': 'Passenger (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0683901', 'cui_str': 'Airplanes'}, {'cui': 'C0018875', 'cui_str': 'Helicopter'}, {'cui': 'C0030405', 'cui_str': 'Parachuting'}]",[],"[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C3263723', 'cui_str': 'Injuries'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0021504', 'cui_str': 'ISS Score'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332677', 'cui_str': 'Major injury (morphologic abnormality)'}]",,0.35668,"RESULTS


Parachute use did not significantly reduce death or major injury (0% for parachute  v  0% for control; P>0.9).","[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Yeh', 'Affiliation': 'Richard A and Susan F Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, 375 Longwood Avenue, Boston, MA 02215, USA ryeh@bidmc.harvard.edu.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Valsdottir', 'Affiliation': 'Richard A and Susan F Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, 375 Longwood Avenue, Boston, MA 02215, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Yeh', 'Affiliation': 'David Geffen School of Medicine, University of California, Los Angeles, CA, USA ryeh@bidmc.harvard.edu.'}, {'ForeName': 'Changyu', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Richard A and Susan F Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, 375 Longwood Avenue, Boston, MA 02215, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kramer', 'Affiliation': 'Richard A and Susan F Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, 375 Longwood Avenue, Boston, MA 02215, USA.'}, {'ForeName': 'Jordan B', 'Initials': 'JB', 'LastName': 'Strom', 'Affiliation': 'Richard A and Susan F Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, 375 Longwood Avenue, Boston, MA 02215, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Secemsky', 'Affiliation': 'Richard A and Susan F Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, 375 Longwood Avenue, Boston, MA 02215, USA.'}, {'ForeName': 'Joanne L', 'Initials': 'JL', 'LastName': 'Healy', 'Affiliation': 'Richard A and Susan F Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, 375 Longwood Avenue, Boston, MA 02215, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Domeier', 'Affiliation': 'Department of Emergency Medicine, University of Michigan and Saint Joseph Hospital, Ann Arbor, MI, USA.'}, {'ForeName': 'Dhruv S', 'Initials': 'DS', 'LastName': 'Kazi', 'Affiliation': 'Richard A and Susan F Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, 375 Longwood Avenue, Boston, MA 02215, USA.'}, {'ForeName': 'Brahmajee K', 'Initials': 'BK', 'LastName': 'Nallamothu', 'Affiliation': 'Michigan Integrated Center for Health Analytics and Medical Prediction, Department of Internal Medicine and Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.k5094']
1564,30943578,Systemic therapy in the management of localized and locally advanced renal cell carcinoma: Current state and future perspectives.,"Systemic therapy strategies in the setting of localized and locally advanced renal cell carcinoma have continued to evolve in two directions: (i) as adjuvant therapy (to reduce the risk of recurrence or progression in high-risk localized groups); or (ii) as neoadjuvant therapy as a strategy to render primary renal tumors amenable to planned surgical resection in settings where radical resection or nephron-sparing surgery was not thought to be safe or feasible. In the realm of adjuvant therapy, the results of adjuvant therapy phase III randomized clinical trials have been mixed and contradictory; nevertheless, the findings of the landmark Sunitinib Treatment of Renal Adjuvant Cancer study have led to approval of sunitinib as an adjuvant agent in the USA. In the realm of neoadjuvant therapy, presurgical tumor reduction has been shown in a number of phase II studies utilizing targeted molecular agents and in a recently published small randomized double-blind placebo-controlled study, and an expanding body of literature suggests benefit in select patients. Thus, large randomized clinical trial data are not present to support this approach, and guidelines for use of presurgical therapy have not been promulgated. The advent of immunomodulation through checkpoint inhibition represents an exciting horizon for adjuvant and neoadjuvant strategies. The present article reviews the current status and future prospects of adjuvant and neoadjuvant therapy in localized and locally advanced renal cell carcinoma.",2019,"In the realm of neoadjuvant therapy, presurgical tumor reduction has been shown in a number of phase II studies utilizing targeted molecular agents and in a recently published small randomized double-blind placebo-controlled study, and an expanding body of literature suggests benefit in select patients.",['localized and locally advanced renal cell carcinoma'],"['Systemic therapy', 'radical resection or nephron-sparing surgery']",[],"[{'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0027713', 'cui_str': 'Nephrons'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],,0.109447,"In the realm of neoadjuvant therapy, presurgical tumor reduction has been shown in a number of phase II studies utilizing targeted molecular agents and in a recently published small randomized double-blind placebo-controlled study, and an expanding body of literature suggests benefit in select patients.","[{'ForeName': 'Sean W', 'Initials': 'SW', 'LastName': 'Berquist', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Kendrick', 'Initials': 'K', 'LastName': 'Yim', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Ryan', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Sunil H', 'Initials': 'SH', 'LastName': 'Patel', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Eldefrawy', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Brittney H', 'Initials': 'BH', 'LastName': 'Cotta', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Aaron W', 'Initials': 'AW', 'LastName': 'Bradshaw', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Meagher', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Bindayi', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Rana R', 'Initials': 'RR', 'LastName': 'McKay', 'Affiliation': 'Division of Medical Oncology, UC San Diego School of Medicine, La Jolla, California, USA.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Autorino', 'Affiliation': 'Division of Urology, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Staehler', 'Affiliation': 'Department of Urology, Ludwig-Maximilian University, Munich, Germany.'}, {'ForeName': 'Ithaar H', 'Initials': 'IH', 'LastName': 'Derweesh', 'Affiliation': 'Department of Urology, UC San Diego School of Medicine, La Jolla, California, USA.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.13943']
1565,31852916,Only vulnerable adults show change in chronic low-grade inflammation after contemplative mental training: evidence from a randomized clinical trial.,"Growing evidence suggests that chronic low-grade inflammation can be reduced through mindfulness-based mental training interventions. However, these results are inconsistent and based on patient populations with heterogeneous conditions. Similar research in healthy adults is lacking. Moreover, common intervention protocols involve varying combinations of different contemplative practices, such that it remains unclear which types of training most effectively influence biomarkers of inflammation. The present study investigated the effect of three distinct 3-month training modules cultivating a) interoception and present-moment focus (Presence), b) socio-affective skills (Affect), or c) socio-cognitive skills (Perspective) on the inflammatory biomarkers interleukin-6 (IL-6) and high sensitive C-reactive protein (hs-CRP) in 298 healthy adults. We observed no group-level effect of training on either biomarker, but trend-level interactions of training type and participant sex. In additionally exploring the influence of participants' baseline inflammation, a selective training effect emerged: Following the Presence module, participants with relatively higher inflammatory load showed stronger reduction in IL-6 on average, and in hs-CRP if they were male. Mindfulness- and attention-based mental practice thus appears most effective when targeting chronic low-grade inflammation in healthy adults, particularly in men. Overall, our data point to a floor effect in the reduction of inflammatory markers through contemplative mental training, suggesting that mental training may be less effective in improving basal biological health outcomes in healthy, low-stressed adults than in vulnerable populations.",2019,"We observed no group-level effect of training on either biomarker, but trend-level interactions of training type and participant sex.","['healthy adults', '298 healthy adults', 'healthy adults, particularly in men']","['training modules cultivating a) interoception and present-moment focus (Presence), b) socio-affective skills (Affect), or c) socio-cognitive skills (Perspective) on the inflammatory biomarkers interleukin-6 (IL-6) and high sensitive C-reactive protein (hs-CRP', 'Mindfulness- and attention-based mental practice']","['chronic low-grade inflammation', 'basal biological health outcomes']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C3850156', 'cui_str': 'Interoception'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",298.0,0.0745838,"We observed no group-level effect of training on either biomarker, but trend-level interactions of training type and participant sex.","[{'ForeName': 'Lara M C', 'Initials': 'LMC', 'LastName': 'Puhlmann', 'Affiliation': 'Research Group ""Social Stress and Family Health"", Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany. puhlmann@cbs.mpg.de.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Engert', 'Affiliation': 'Research Group ""Social Stress and Family Health"", Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Filia', 'Initials': 'F', 'LastName': 'Apostolakou', 'Affiliation': 'Department of Clinical Biochemistry, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Papassotiriou', 'Affiliation': 'Department of Clinical Biochemistry, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'Chrousos', 'Affiliation': 'First Department of Pediatrics, National and Kapodistrian University of Athens Medical School, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vrtička', 'Affiliation': 'Research Group ""Social Stress and Family Health"", Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Singer', 'Affiliation': 'Social Neuroscience Lab, Max Planck Society, Berlin, Germany.'}]",Scientific reports,['10.1038/s41598-019-55250-3']
1566,30917336,"Cognitive behavioral therapy, mindfulness, and cortisol habituation: A randomized controlled trial.","BACKGROUND


Hypothalamic-pituitary-adrenocortical (HPA) axis dysregulation is associated with disease and may be indexed by poor cortisol habituation (i.e., a failure to show decreased responding with repeated stressor exposure). Thus, stress management training that can enhance HPA axis habituation may benefit health. To date, the effects of Mindfulness Based Stress Reduction (MBSR) and Cognitive Behavioral Therapy (CBT) interventions on HPA axis habituation remain untested. To test the effects of MBSR and CBT on HPA axis habituation, the present study used a parallel arm randomized controlled trial.
METHODS


Healthy adults reporting moderate-to-high stress (n = 138) were randomly assigned to a 6-week MBSR intervention, a 6-week CBT intervention, or Waitlist control group. Post-intervention, participants completed a social-evaluative performance stressor during each of two laboratory visits scheduled 48-h apart. Salivary cortisol was collected pre-stressor, and 25, 35, and 60 min post-stressor onset during each visit. Final analyses included 86 participants who completed procedures up to the first laboratory visit.
RESULTS


Relative to the control condition, both MBSR and CBT groups showed greater cortisol habituation. The MBSR group exhibited marginally greater habituation than the Waitlist group in cortisol samples corresponding to the recovery time points (35 and 60 min post-stressor onset). In contrast, the CBT group showed greater habituation than the Waitlist across all sampling timepoints collected (pre-stressor, 25, 35, and 60 min post-stressor onset). Yet, the CBT group also demonstrated elevated pre-stressor cortisol during the first visit.
CONCLUSIONS


Results suggest that MBSR and CBT interventions promote greater HPA axis habituation relative to no training, but do not reduce overall cortisol output (i.e., across both visits). Observed differences between CBT and MBSR training in relation to cortisol habituation are discussed.",2019,The MBSR group exhibited marginally greater habituation than the Waitlist group in cortisol samples corresponding to the recovery time points (35 and 60 min post-stressor onset).,"['86 participants who completed procedures up to the first laboratory visit', 'Healthy adults reporting moderate-to-high stress (n\u202f=\u202f138']","['CBT', 'CBT and MBSR training', 'MBSR intervention, a 6-week CBT intervention, or Waitlist control group', 'MBSR and CBT', 'Mindfulness Based Stress Reduction (MBSR) and Cognitive Behavioral Therapy (CBT) interventions', 'MBSR and CBT interventions']","['Cognitive behavioral therapy, mindfulness, and cortisol habituation', 'cortisol habituation', 'HPA axis habituation', 'overall cortisol output', 'elevated pre-stressor cortisol', 'Salivary cortisol', 'habituation']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation (disorder)'}, {'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}]",138.0,0.019297,The MBSR group exhibited marginally greater habituation than the Waitlist group in cortisol samples corresponding to the recovery time points (35 and 60 min post-stressor onset).,"[{'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Manigault', 'Affiliation': 'Ohio University - Department of Psychology, Athens, OH 45701, USA.'}, {'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Shorey', 'Affiliation': 'University of Wisconsin-Milwaukee - Department of Psychology, Milwaukee, WI 53211, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Hamilton', 'Affiliation': 'Ohio University - Department of Psychology, Athens, OH 45701, USA; Ohio University - Heritage College of Osteopathic Medicine, Athens, OH 45701, USA.'}, {'ForeName': 'Matt C', 'Initials': 'MC', 'LastName': 'Scanlin', 'Affiliation': 'Ohio University - Department of Psychology, Athens, OH 45701, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Woody', 'Affiliation': 'Ohio State University - Institute for Behavioral Medicine Research, Columbus 43210, USA.'}, {'ForeName': 'Wilson S', 'Initials': 'WS', 'LastName': 'Figueroa', 'Affiliation': 'Ohio State University - Wexner Medical Center, Columbus 43210, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Ohio University - Department of Psychology, Athens, OH 45701, USA.'}, {'ForeName': 'Peggy M', 'Initials': 'PM', 'LastName': 'Zoccola', 'Affiliation': 'Ohio University - Department of Psychology, Athens, OH 45701, USA. Electronic address: zoccola@ohio.edu.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.03.009']
1567,31479722,Evolocumab for Early Reduction of LDL Cholesterol Levels in Patients With Acute Coronary Syndromes (EVOPACS).,"BACKGROUND


Although guidelines recommend in-hospital initiation of high-intensity statin therapy in patients with acute coronary syndromes (ACS), low-density lipoprotein cholesterol (LDL-C) target levels are frequently not attained. Evolocumab, a rapidly acting, potent LDL-C-lowering drug, has not been studied in the acute phase of ACS.
OBJECTIVES


The purpose of this study was to assess the feasibility, safety, and LDL-C-lowering efficacy of evolocumab initiated during the in-hospital phase of ACS.
METHODS


The authors conducted an investigator-initiated, randomized, double-blind, placebo-controlled trial involving 308 patients hospitalized for ACS with elevated LDL-C levels (≥1.8 mmol/l on high-intensity statin for at least 4 weeks; ≥2.3 mmol/l on low- or moderate-intensity statin; or ≥3.2 mmol/l on no stable dose of statin). Patients were randomly assigned 1:1 to receive subcutaneous evolocumab 420 mg or matching placebo, administered in-hospital and after 4 weeks, on top of atorvastatin 40 mg. The primary endpoint was percentage change in calculated LDL-C from baseline to 8 weeks.
RESULTS


Most patients (78.2%) had not been on previous statin treatment. Mean LDL-C levels decreased from 3.61 to 0.79 mmol/l at week 8 in the evolocumab group, and from 3.42 to 2.06 mmol/l in the placebo group; the difference in mean percentage change from baseline was -40.7% (95% confidence interval: -45.2 to -36.2; p < 0.001). LDL-C levels <1.8 mmol/l were achieved at week 8 by 95.7% of patients in the evolocumab group versus 37.6% in the placebo group. Adverse events and centrally adjudicated cardiovascular events were similar in both groups.
CONCLUSIONS


In this first randomized trial assessing a PCSK9 antibody in the very high-risk setting of ACS, evolocumab added to high-intensity statin therapy was well tolerated and resulted in substantial reduction in LDL-C levels, rendering >95% of patients within currently recommended target levels. (EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes [EVOPACS]; NCT03287609).",2019,"Mean LDL-C levels decreased from 3.61 mmol/L to 0.79 mmol/L at week 8 in the evolocumab group, and from 3.42 mmol/L to 2.06 mmol/L in the placebo group; the difference in mean percentage change from baseline was -40.7% (95% CI: -45.2 to -36.2; p<0.001).","['308 patients hospitalized for ACS with elevated LDL-C levels (≥1.8 mmol/L on high-intensity statin for at least 4 weeks; ≥2.3 mmol/L on low- or moderate-intensity statin; or ≥3.2 mmol/L on no stable dose of statin', 'patients with acute coronary syndromes (ACS', 'Patients with Acute Coronary Syndromes (EVOPACS']","['evolocumab', 'subcutaneous evolocumab 420mg or matching placebo', 'placebo', 'Evolocumab', 'atorvastatin 40mg']","['LDL-Cholesterol Levels', 'LDL-C levels', 'Adverse events and centrally adjudicated cardiovascular events', 'feasibility, safety, and LDL-C lowering efficacy', 'Mean LDL-C levels', 'percentage change in calculated LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1616508', 'cui_str': 'atorvastatin 40 MG [Lipitor]'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}]",308.0,0.290208,"Mean LDL-C levels decreased from 3.61 mmol/L to 0.79 mmol/L at week 8 in the evolocumab group, and from 3.42 mmol/L to 2.06 mmol/L in the placebo group; the difference in mean percentage change from baseline was -40.7% (95% CI: -45.2 to -36.2; p<0.001).","[{'ForeName': 'Konstantinos C', 'Initials': 'KC', 'LastName': 'Koskinas', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland. Electronic address: stephan.windecker@insel.ch.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Pedrazzini', 'Affiliation': 'Cardiocentro, Lugano, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology, Fribourg Hospital and University, Fribourg, Switzerland.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Matter', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Muller', 'Affiliation': 'Service of Cardiology, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Häner', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Gencer', 'Affiliation': 'Department of Cardiology, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Crljenica', 'Affiliation': 'Cardiocentro, Lugano, Switzerland.'}, {'ForeName': 'Poorya', 'Initials': 'P', 'LastName': 'Amini', 'Affiliation': 'CTU Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Deckarm', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Iglesias', 'Affiliation': 'Department of Cardiology, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'CTU Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Mach', 'Affiliation': 'Department of Cardiology, Geneva University Hospital, Geneva, Switzerland.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.08.010']
1568,30991255,The gut-brain relationship: Investigating the effect of multispecies probiotics on anxiety in a randomized placebo-controlled trial of healthy young adults.,"INTRO


There has been an increased interest in understanding the therapeutic effect of gut-microbiota on health, particularly in mental health. However, limited research into the connection between gut-microbiota and mental health makes this study an important endeavor in exploring the effect of gut-microbiota, through probiotics intervention, on mental health like anxiety and factors related to anxiety (e.g., anxiety control, affect, negative mood regulation, and worry).
METHOD


Healthy college students (N = 86; 75.6% female), average age of 20.59, participated in a double-blind, placebo-control, and randomization-control study. Eligible participants completed a baseline survey before being assigned to a condition, which consisted of four probiotics conditions and one placebo condition. After 28 days of daily intake, the participants returned to complete their exit survey.
RESULT


Probiotics were observed to improve panic anxiety, neurophysiological anxiety, negative affect, worry, and increase negative mood regulation. Furthermore, post hoc analyses revealed that the CFU (colony-forming unit) level was more effective than species counts in accounting for the number of significant improvements. A ceiling effect was detected in the study, participants with high distress reported higher number of improvements than those with normative distress.
CONCLUSION


Overall, this study is the first to examine the effect of CFU and species count on probiotics' efficacy. The study's finding suggested that probiotics may have the therapeutic potential to treat anxiety, however, further research is necessary to make that determination.",2019,"Probiotics were observed to improve panic anxiety, neurophysiological anxiety, negative affect, worry, and increase negative mood regulation.","['Healthy college students', 'healthy young adults', 'N\xa0=\xa086; 75.6% female), average age of 20.59, participated in a double-blind, placebo-control, and randomization-control study']","['multispecies probiotics', 'placebo condition', 'placebo']","['panic anxiety, neurophysiological anxiety, negative affect, worry, and increase negative mood regulation']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",,0.113799,"Probiotics were observed to improve panic anxiety, neurophysiological anxiety, negative affect, worry, and increase negative mood regulation.","[{'ForeName': 'Nhan', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'Department of Psychology, Houston Baptist University, 7502 Fondren Rd, Houston, TX 77074, United States. Electronic address: nhan.tran@utexas.edu.'}, {'ForeName': 'Masha', 'Initials': 'M', 'LastName': 'Zhebrak', 'Affiliation': 'Department of Psychology, Houston Baptist University, 7502 Fondren Rd, Houston, TX 77074, United States.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Yacoub', 'Affiliation': 'Department of Psychology, Houston Baptist University, 7502 Fondren Rd, Houston, TX 77074, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pelletier', 'Affiliation': 'Department of Psychology, Houston Baptist University, 7502 Fondren Rd, Houston, TX 77074, United States. Electronic address: jpelletier@hbu.edu.'}, {'ForeName': 'Darby', 'Initials': 'D', 'LastName': 'Hawley', 'Affiliation': 'Department of Psychology, Houston Baptist University, 7502 Fondren Rd, Houston, TX 77074, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2019.04.043']
1569,31029616,Myocardial Blood Flow and Coronary Flow Reserve During 3 Years Following Bioresorbable Vascular Scaffold Versus Metallic Drug-Eluting Stent Implantation: The VANISH Trial.,"OBJECTIVES


The randomized clinical VANISH (Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion: A Randomized [ 15 O]H 2 O PET/CT Study) trial was conducted to assess quantitative myocardial blood flow (MBF) during resting, hyperemia, and cold pressor testing (CPT) with positron emission tomographic perfusion imaging after the implantation of a bioresorbable everolimus-eluting scaffold compared with a drug-eluting stent.
BACKGROUND


Long-term resorption of the bioresorbable everolimus-eluting scaffold reinstates normal vessel geometry, allowing natural regeneration of the newly formed endothelium with revival of vasomotor function.
METHODS


Sixty patients (18 to 65 years of age) with single-vessel disease and type A or B1 lesions were randomized in a 1-to-1 fashion. Approximately 1 month, 1 year, and 3 years after device implantation, patients underwent [ 15 O]H 2 O cardiac positron emission tomography. The primary endpoint was the interaction of device type and evolution over time of hyperemic MBF, coronary flow reserve, or CPT reserve. At 3-year follow-up, control invasive coronary angiography with optical coherence tomography was performed.
RESULTS


Fifty-nine (98%), 56 (93%), and 51 (85%) patients successfully completed 1-month, 1-year, and 3-year follow-up positron emission tomography, respectively, and no culprit vessel events were registered during follow-up time. The primary study endpoint (i.e., interaction between device type and time) was nonsignificant for hyperemic MBF, CPT reserve, and coronary flow reserve (p > 0.05 for all). In all patients, hyperemic MBF decreased from 1 to 3 years (p = 0.02), while coronary flow reserve was lower at 3-year follow-up compared with 1-month and 1-year follow-up (p = 0.03 for both). After 3 years, percentage area stenosis measured with optical coherence tomography was higher within the bioresorbable everolimus-eluting scaffold compared with the drug-eluting stent (p = 0.03).
CONCLUSIONS


The hypothesized beneficial effects of scaffold resorption did not translate to improved MBF during maximal hyperemia or endothelium-dependent vasodilation by CPT.",2019,"After 3 years, percentage area stenosis measured with optical coherence tomography was higher within the bioresorbable everolimus-eluting scaffold compared with the drug-eluting stent (p = 0.03).
",['Sixty patients (18 to 65 years of age) with single-vessel disease and type A or B1 lesions'],"['Vascular Reparative Therapy', 'control invasive coronary angiography with optical coherence tomography', 'Bioresorbable Vascular Scaffold Versus Metallic Drug-Eluting Stent Implantation']","['hyperemic MBF, CPT reserve, and coronary flow reserve', 'Vasomotor Function and Myocardial Perfusion', 'percentage area stenosis measured with optical coherence tomography', 'culprit vessel events', 'interaction of device type and evolution over time of hyperemic MBF, coronary flow reserve, or CPT reserve', 'coronary flow reserve', 'Myocardial Blood Flow and Coronary Flow Reserve', 'hyperemic MBF', 'quantitative myocardial blood flow (MBF) during resting, hyperemia, and cold pressor testing (CPT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0856737', 'cui_str': 'Single vessel disease'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0232365', 'cui_str': 'Vasomotor function (observable entity)'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}]",,0.107485,"After 3 years, percentage area stenosis measured with optical coherence tomography was higher within the bioresorbable everolimus-eluting scaffold compared with the drug-eluting stent (p = 0.03).
","[{'ForeName': 'Wijnand J', 'Initials': 'WJ', 'LastName': 'Stuijfzand', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Schumacher', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Roel S', 'Initials': 'RS', 'LastName': 'Driessen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Lammertsma', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Amber L', 'Initials': 'AL', 'LastName': 'Bakker', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Mischa T', 'Initials': 'MT', 'LastName': 'Rijnierse', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nap', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Yolande', 'Initials': 'Y', 'LastName': 'Appelman', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Maarten A', 'Initials': 'MA', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Jorrit S', 'Initials': 'JS', 'LastName': 'Lemkes', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Pieter G', 'Initials': 'PG', 'LastName': 'Raijmakers', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knaapen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands. Electronic address: p.knaapen@vumc.nl.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.03.004']
1570,31539423,The effectiveness of repeating a social norm feedback intervention to high prescribers of antibiotics in general practice: a national regression discontinuity design.,"OBJECTIVES


Unnecessary antibiotic prescribing contributes to antimicrobial resistance. A randomized controlled trial in 2014-15 showed that a letter from England's Chief Medical Officer (CMO) to high-prescribing GPs, giving feedback about their prescribing relative to the norm, decreased antibiotic prescribing. The CMO sent further feedback letters in succeeding years. We evaluated the effectiveness of the repeated feedback intervention.
METHODS


Publicly available databases were used to identify GP practices whose antibiotic prescribing was in the top 20% nationally (the intervention group). In April 2017, GPs in every practice in the intervention group (n=1439) were sent a letter from the CMO. The letter stated that, 'the great majority of practices in England prescribe fewer antibiotics per head than yours'. Practices in the control group received no communication (n=5986). We used a regression discontinuity design to evaluate the intervention because assignment to the intervention condition was exogenous, depending on a 'rating variable'. The outcome measure was the average rate of antibiotic items dispensed from April 2017 to September 2017.
RESULTS


The GP practices who received the letter changed their prescribing rates by -3.69% (95% CI=-2.29 to -5.10; P<0.001), representing an estimated 124 952 fewer antibiotic items dispensed. The effect is robust to different specifications of the model.
CONCLUSIONS


Social norm feedback from a high-profile messenger continues to be effective when repeated. It can substantially reduce antibiotic prescribing at low cost and on a national scale. Therefore, it is a worthwhile addition to antimicrobial stewardship programmes.",2019,"The GP practices who received the letter changed their prescribing rates by -3.69% (95% CI=-2.29 to -5.10; P<0.001), representing an estimated 124 952 fewer antibiotic items dispensed.","['high prescribers of antibiotics in general practice', ""2014-15 showed that a letter from England's Chief Medical Officer (CMO) to high-prescribing GPs, giving feedback about their prescribing relative to the norm, decreased antibiotic prescribing""]",['social norm feedback intervention'],"['average rate of antibiotic items', 'prescribing rates']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0557516', 'cui_str': 'Medical officer (occupation)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]","[{'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}]",,0.0266698,"The GP practices who received the letter changed their prescribing rates by -3.69% (95% CI=-2.29 to -5.10; P<0.001), representing an estimated 124 952 fewer antibiotic items dispensed.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ratajczak', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gold', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hailstone', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz392']
1571,29457317,"Effects of alcohol intoxication on self-reported drinking patterns, expectancies, motives and personality: a randomized controlled experimental study.","Alcohol intoxication may affect self-reports of alcohol use and related constructs, such as impulsivity and dependence symptoms. Improved knowledge about potential systematic reporting biases induced by alcohol, e.g. through disinhibition, may be relevant for the assessment of intoxicated individuals both in clinical routine and research. We therefore randomly assigned 54 socially drinking males aged 18 to 19 without lifetime diagnosis of DSM-IV alcohol dependence to one of two experimental arms: either placebo infusion at day 1 and alcohol infusion at day 2, or vice versa. The lab-based intravenous alcohol infusion produced a constant blood alcohol level of 0.08 percent. On each day, participants completed the Alcohol Use Disorders Identification Test, as well as other questionnaires on alcohol expectancies, drinking motives and substance use-related temperament traits. We found that alcohol significantly increased self-reported expectancies (tension reduction) and motives (conformity; η 2   = .16-.23), but we observed no effect of sequence, i.e. alcohol first versus placebo first (P corr   ≥ .118). High baseline alcohol expectancies did not moderate alcohol effects (P corr   ≥ .462). We conclude that moderate alcohol intoxication might not generally affect the reliability of self-reported alcohol use, alcohol use problems and psychological concepts related to drinking behavior in young males without alcohol dependence. Future studies could examine larger, less selective and clinical samples for possible alcohol effects on self-report measures related to alcohol consumption.",2019,"We found that alcohol significantly increased self-reported expectancies (tension reduction) and motives (conformity; η 2   = .16-.23), but we observed no effect of sequence, i.e. alcohol first versus placebo first (P corr   ≥ .118).","['54 socially drinking males aged 18 to 19 without lifetime diagnosis of DSM-IV alcohol dependence to one of two experimental arms: either', 'young males without alcohol dependence']","['alcohol intoxication', 'placebo infusion at day 1 and alcohol infusion at day 2, or vice versa']","['constant blood alcohol level', 'self-reported drinking patterns, expectancies, motives and personality', 'alcohol expectancies, drinking motives and substance use-related temperament traits']","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0001969', 'cui_str': 'Drunkenness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1286344', 'cui_str': 'Drinking pattern (observable entity)'}, {'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}]",54.0,0.0109988,"We found that alcohol significantly increased self-reported expectancies (tension reduction) and motives (conformity; η 2   = .16-.23), but we observed no effect of sequence, i.e. alcohol first versus placebo first (P corr   ≥ .118).","[{'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Kuitunen-Paul', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Obst', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sommer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Paula T', 'Initials': 'PT', 'LastName': 'Kuitunen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ulrich S', 'Initials': 'US', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}]",Addiction biology,['10.1111/adb.12604']
1572,31724966,Effect of semaglutide on coronary atherosclerosis progression in patients with type II diabetes: rationale and design of the semaglutide treatment on coronary progressiontrial.,"BACKGROUND


Cardiovascular morbidity and mortality are a major burden in patients with type 2 diabetic mellitus. In a landmark study, semaglutide (an injectable glucagon like peptide-1 receptor agonist) has been shown to significantly reduce cardiovascular events, however, the mechanism of benefit is still unknown. The primary hypothesis of our current study is to assess the effect of semaglutide to reduce progression of noncalcified coronary atherosclerotic plaque volume as measured by serial coronary CTA as compared to placebo in persons with diabetes over 1 year.
METHODS


One hundred forty patients will be enrolled after signing informed consent and followed up for 12 months and with a phone call 30 days after medical discontinuation. All the participants will undergo coronary artery calcium scoring and coronary computed tomography angiography at our center at baseline and 12 months. Eligible participants will be randomly assigned to semaglutide 2 mg/1.5 ml (1.34 mg/ml) prefilled pen for subcutaneous (SC) injection or placebo 1.5 ml, pen-injector for SC injection in a 1:1 fashion as add-on to their standard of care.
RESULTS


As of July 2019, the study was approximately 30% enrolled with an estimated enrollment completion by first quarter of 2020 and end of study by first quarter 2021. Thirty patients were enrolled as of 23 July 2019. Preliminary data of demographics and clinical characteristics were summarized.
CONCLUSION


Our current study will provide important imaging-derived data that may add relevance to the clinically derived outcomes from liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results and semaglutide and cardiovascular outcomes in patients with type 2 diabetic mellitus 6 trials.",2019,"As of July 2019, the study was approximately 30% enrolled with an estimated enrollment completion by first quarter of 2020 and end of study by first quarter 2021.","['patients with type 2 diabetic mellitus 6 trials', 'As of July 2019, the study was approximately 30% enrolled with an estimated enrollment completion by first quarter of 2020 and end of study by first quarter 2021', 'patients with type II diabetes', 'persons with diabetes over 1 year', 'Eligible participants', 'Thirty patients were enrolled as of 23 July 2019', 'patients with type 2 diabetic mellitus', 'One hundred forty patients will be enrolled after signing informed consent and followed up for 12 months and with a phone call 30 days after medical discontinuation']","['placebo', 'semaglutide', 'coronary artery calcium scoring and coronary computed tomography angiography', 'semaglutide 2 mg/1.5 ml (1.34 mg/ml) prefilled pen for subcutaneous (SC) injection or placebo 1.5 ml, pen-injector for SC injection']","['cardiovascular events', 'coronary atherosclerosis progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C3484386', 'cui_str': 'Coronary artery calcium score'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C4517501', 'cui_str': '1.34'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C4319659', 'cui_str': 'Pen (unit of presentation)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4025916', 'cui_str': 'Pen Injector'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0010054', 'cui_str': 'Coronary Atherosclerosis'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",140.0,0.156861,"As of July 2019, the study was approximately 30% enrolled with an estimated enrollment completion by first quarter of 2020 and end of study by first quarter 2021.","[{'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Hamal', 'Affiliation': ''}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Cherukuri', 'Affiliation': ''}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Birudaraju', 'Affiliation': ''}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Kinninger', 'Affiliation': ''}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Doshi', 'Affiliation': ''}, {'ForeName': 'Kashif', 'Initials': 'K', 'LastName': 'Shaikh', 'Affiliation': ''}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': ''}]",Coronary artery disease,['10.1097/MCA.0000000000000830']
1573,31012999,A comparative study on the effectiveness of herbal extracts vs 2.5% benzoyl peroxide in the treatment of mild to moderate acne vulgaris.,"BACKGROUND


Although there is a standard guideline for the treatment of acne, it is still a common skin disease, and suboptimal medication adherence is a major reason for treatment failure. Herbal extracts are an interesting alternative medicine because they consist of a variety of active ingredients. Moreover, herbal extracts may have improved therapeutic efficacy because of the combination of various herbs.
OBJECTIVES


To evaluate the effectiveness of herbal extracts for the treatment of mild to moderate acne vulgaris.
METHODS


A total of 77 patients were randomized to receive either an herbal extract or 2.5% benzoyl peroxide, which were applied for a period of 12 weeks. Acne lesion counts, adherence, porphyrin counts, the Dermatology Life Quality Index, satisfaction and side effects were assessed.
RESULT


At the 12-week point, the acne lesion counts decreased, with statistically significant differences from the baseline values in both groups and for all types of acne (P-value < 0.001). The adherence rate was significantly higher in the patients using the herbal extract than in the patients using 2.5% benzoyl peroxide (P-value = 0.002). There was no statistically significant difference in terms of porphyrin counts, spot scores, the Dermatology Life Quality Index or satisfaction with efficacy between the groups; however, satisfaction with drug administration was significantly higher in the patients using the herbal extract (P-value = 0.001).
CONCLUSION


Herbal extracts could be beneficial for anti-acne pharmaceutical preparations and may be used as an alternative medicine for patients with mild to moderate acne vulgaris who do not adhere to benzoyl peroxide treatment.",2019,"There was no statistically significant difference in terms of porphyrin counts, spot scores, the Dermatology Life Quality Index or satisfaction with efficacy between the groups; however, satisfaction with drug administration was significantly higher in the patients using the herbal extract (P-value = 0.001).
","['77 patients', 'patients with mild to moderate acne vulgaris who do not adhere to benzoyl peroxide treatment', 'mild to moderate acne vulgaris']","['herbal extracts vs 2.5% benzoyl peroxide', 'herbal extracts', 'herbal extract or 2.5% benzoyl peroxide']","['satisfaction with drug administration', 'adherence rate', 'acne lesion counts', 'therapeutic efficacy', 'porphyrin counts, spot scores, the Dermatology Life Quality Index or satisfaction with efficacy', 'Acne lesion counts, adherence, porphyrin counts, the Dermatology Life Quality Index, satisfaction and side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032712', 'cui_str': 'Porphyrins'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",77.0,0.0297194,"There was no statistically significant difference in terms of porphyrin counts, spot scores, the Dermatology Life Quality Index or satisfaction with efficacy between the groups; however, satisfaction with drug administration was significantly higher in the patients using the herbal extract (P-value = 0.001).
","[{'ForeName': 'Patrida', 'Initials': 'P', 'LastName': 'Lubtikulthum', 'Affiliation': 'Skin Center, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Nanticha', 'Initials': 'N', 'LastName': 'Kamanamool', 'Affiliation': 'Department of Preventive and Social Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Montree', 'Initials': 'M', 'LastName': 'Udompataikul', 'Affiliation': 'Skin Center, Srinakharinwirot University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.12962']
1574,30281882,Effectiveness of interventions for unstable patients on antiretroviral therapy in South Africa: results of a cluster-randomised evaluation.,"BACKGROUND


As loss from HIV care is an ongoing challenge globally, interventions are needed for patients who don't achieve or maintain ART stability. The 2015 South African National Adherence Guidelines (AGL) for Chronic Diseases include two interventions targeted at unstable patients: early tracing of patients who miss visits (TRIC) and enhanced adherence counselling (EAC).
METHODS


As part of a cluster-randomised evaluation at 12 intervention and 12 control clinics in four provinces, intervention sites implemented the AGL interventions, while control sites retained standard care. We report on outcomes of EAC for patients with an elevated viral load (>400 copies/ml) and for TRIC patients who missed a visit by >5 days. We estimated risk differences (RD) of 3 and 12-month viral resuppression (<400 copies/ml) and 12-month retention with cluster adjustment using generalised estimating equations and controlled for imbalances using difference-in-differences compared to all eligible in 2015, prior to intervention roll-out.
RESULTS


For EAC, we had 358 intervention and 505 control site patients (61% female, median ART initiation CD4 count 154 cells/μl). We found no difference between arms in 3-month resuppression (RD: -1.7%; 95%CI: -4.3% to 0.9%), but <20% of patients had a repeat viral load within 3 months (19.8% intervention, 13.5% control). Including the entire clinic population eligible for EAC with a repeat viral load at all evaluation sites (n = 934), intervention sites showed a small increase in 3-month resuppression (28% vs. 25%, RD 3.0%; 95%CI: -2.7% to 8.8%). Adjusting for baseline differences increased the RD to 8.1% (95% CI: -0.1% to 17.2%). However, we found no differences in 12-month suppression (RD: 1.5%; 95% CI: -14.1% to 17.1% but suppression was low overall at 40%) or retention (RD: 2.8%; 95% CI: -7.5% to 13.2%). For TRIC, we enrolled 155 at intervention sites and 248 at control sites (44% >40 years, 67% female, median CD4 count 212 cells/μl). We found no difference between groups in return to care by 12 months (RD: -6.8%; 95% CI: -17.7% to 4.8%). During the study period, control sites continued to use tracing within standard care, however, potentially masking intervention effects.
CONCLUSIONS


Enhanced adherence counselling showed no benefit over 12 months. Implementation of the tracing intervention under the new guidelines was similar to the standard of care. Interventions that aim to return unstable patients to care should incorporate active monitoring to determine if the interventions are effective.",2018,We found no difference between groups in return to care by 12 months (RD: -6.8%; 95% CI: -17.7% to 4.8%).,"['2015 South African National Adherence Guidelines (AGL) for Chronic Diseases include two interventions targeted at unstable patients: early tracing of patients who miss visits (TRIC) and enhanced adherence counselling (EAC', 'unstable patients on antiretroviral therapy in South Africa', 'patients with an elevated viral load (>400 copies/ml) and for TRIC patients who missed a visit by >5 days', 'For TRIC, we enrolled 155 at intervention sites and 248 at control sites (44% >40 years, 67% female, median CD4 count 212 cells/μl']",['EAC'],"['repeat viral load', '3-month resuppression']","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]",[],"[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.0745362,We found no difference between groups in return to care by 12 months (RD: -6.8%; 95% CI: -17.7% to 4.8%).,"[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Fox', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Sophie J S', 'Initials': 'SJS', 'LastName': 'Pascoe', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, Faculty of Health Sciences, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Amy N', 'Initials': 'AN', 'LastName': 'Huber', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, Faculty of Health Sciences, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, Faculty of Health Sciences, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mokgadi', 'Initials': 'M', 'LastName': 'Phokojoe', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Marelize', 'Initials': 'M', 'LastName': 'Gorgens', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}, {'ForeName': 'Yogan', 'Initials': 'Y', 'LastName': 'Pillay', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Fraser-Hurt', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13152']
1575,32410715,Effects of multidomain versus single-domain training on executive control and memory in older adults: study protocol for a randomized controlled trial.,"BACKGROUND


Previous research suggests that both cognitive training and physical exercise help to maintain brain health and cognitive functions that decline with age. Some studies indicate that combined interventions may produce larger effects than each intervention alone. The aim of this study is to investigate the effects of combined cognitive and physical training compared to cognitive training and physical training alone on executive control and memory functions in healthy older adults.
OBJECTIVES


The main objectives of this four-arm randomized controlled trial (RCT) are: to investigate the synergetic effects of a simultaneous, group-based multidomain training program that combines cognitive video-game training with physical exercise, in comparison to those produced by cognitive training combined with physical control activity, physical training combined with cognitive control activity, or a combination of both control activities; to investigate whether event-related potential latencies of the P2 component are shorter and N2 and P3b components assessed in a memory-based task switching task are enhanced after training; and to find out whether possible enhancements persist after a 3-month period without training.
METHODS


In this randomized, single-blind, controlled trial, 144 participants will be randomly assigned to one of the four combinations of cognitive training and physical exercise. The cognitive component will be either video-game training (cognitive intervention, CI) or video games not specifically designed to train cognition (cognitive control, CC). The physical exercise component will either emphasize endurance, strength, and music-movement coordination (exercise intervention, EI) or stretching, toning, and relaxation (exercise control, EC).
DISCUSSION


This RCT will investigate the short and long-term effects of multidomain training, compared to cognitive training and physical training alone, on executive control and memory functions in healthy older adults, in comparison with the performance of an active control group.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03823183. Registered on 21 January 2019.",2020,"This RCT will investigate the short and long-term effects of multidomain training, compared to cognitive training and physical training alone, on executive control and memory functions in healthy older adults, in comparison with the performance of an active control group.
","['healthy older adults', '144 participants', 'older adults']","['cognitive training and physical exercise', 'video-game training (cognitive intervention, CI) or video games not specifically designed to train cognition (cognitive control, CC', 'multidomain versus single-domain training', 'cognitive training and physical training alone', 'combined cognitive and physical training', 'multidomain training', 'physical exercise component will either emphasize endurance, strength, and music-movement coordination (exercise intervention, EI) or stretching, toning, and relaxation (exercise control, EC', 'cognitive training combined with physical control activity, physical training combined with cognitive control activity, or a combination of both control activities']","['executive control and memory functions', 'executive control and memory']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",144.0,0.0322726,"This RCT will investigate the short and long-term effects of multidomain training, compared to cognitive training and physical training alone, on executive control and memory functions in healthy older adults, in comparison with the performance of an active control group.
","[{'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Ballesteros', 'Affiliation': 'Studies on Aging and Neurodegenerative Diseases Research Group, Universidad Nacional de Educación a Distancia, Madrid, Spain. mballesteros@psi.uned.es.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Rieker', 'Affiliation': 'Studies on Aging and Neurodegenerative Diseases Research Group, Universidad Nacional de Educación a Distancia, Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mayas', 'Affiliation': 'Studies on Aging and Neurodegenerative Diseases Research Group, Universidad Nacional de Educación a Distancia, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Prieto', 'Affiliation': 'Studies on Aging and Neurodegenerative Diseases Research Group, Universidad Nacional de Educación a Distancia, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Toril', 'Affiliation': 'Studies on Aging and Neurodegenerative Diseases Research Group, Universidad Nacional de Educación a Distancia, Madrid, Spain.'}, {'ForeName': 'María Pilar', 'Initials': 'MP', 'LastName': 'Jiménez', 'Affiliation': 'Studies on Aging and Neurodegenerative Diseases Research Group, Universidad Nacional de Educación a Distancia, Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Reales', 'Affiliation': 'Studies on Aging and Neurodegenerative Diseases Research Group, Universidad Nacional de Educación a Distancia, Madrid, Spain.'}]",Trials,['10.1186/s13063-020-04293-3']
1576,31003926,The LEADER trial in type 2 diabetes: Were the characteristics and outcomes of the participants representative?,"AIMS


To compare the characteristics and outcomes of people with type 2 diabetes recruited to the LEADER trial to those of participants in the contemporaneous community-based Fremantle Diabetes Study Phase II (FDS2) who fulfilled LEADER entry criteria.
METHODS


Baseline characteristics of LEADER and LEADER-eligible FDS2 participants were compared using bivariate methods. Incidence rates of the primary (nonfatal myocardial infarction, nonfatal stroke, cardiovascular disease (CVD) death) and other outcomes in the LEADER placebo group were compared with those in LEADER-eligible FDS2 participants during 3.8 years after entry, the median LEADER follow-up.
RESULTS


Of 1551 FDS2 type 2 participants, 323 (20.8%) were LEADER-eligible. Compared with the LEADER sample, they were an average 6 years older, and were less likely to be male, obese and to have prior CVD. There were 3.9 and 2.9 primary outcomes/100 patient-years in LEADER placebo-treated and FDS2 LEADER-eligible patients, respectively. Incidence rates for first myocardial infarction and stroke were 1.9 and 2.1 events/100 patient-years and 1.1 and 1.0 events/100 patient-years, respectively. FDS2 LEADER-eligible patients had a lower CVD death rate of 0.8 versus 1.6/100 patient-years in the LEADER placebo group, but their non-CVD mortality was greater (2.1 versus 1.0/100 patient-years).
CONCLUSIONS


These data suggest recruitment bias in type 2 diabetes CVD outcome trials.",2019,"FDS2 LEADER-eligible patients had a lower CVD death rate of 0.8 versus 1.6/100 patient-years in the LEADER placebo group, but their non-CVD mortality was greater (2.1 versus 1.0/100 patient-years).
","['Of 1551 FDS2 type 2 participants, 323 (20.8%) were LEADER-eligible', 'people with type 2 diabetes recruited to the LEADER trial to those of participants in the contemporaneous community-based Fremantle Diabetes Study Phase II (FDS2) who fulfilled LEADER entry criteria']",['LEADER placebo'],"['Incidence rates', 'Incidence rates of the primary (nonfatal myocardial infarction, nonfatal stroke, cardiovascular disease (CVD) death', 'CVD death rate', 'CVD mortality']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",1551.0,0.265286,"FDS2 LEADER-eligible patients had a lower CVD death rate of 0.8 versus 1.6/100 patient-years in the LEADER placebo group, but their non-CVD mortality was greater (2.1 versus 1.0/100 patient-years).
","[{'ForeName': 'Timothy M E', 'Initials': 'TME', 'LastName': 'Davis', 'Affiliation': 'Medical School, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia. Electronic address: tim.davis@uwa.edu.au.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Davis', 'Affiliation': 'Medical School, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.03.005']
1577,31025578,Palliative Transurethral Resection of the Prostate in Patients with Metastatic Prostate Cancer: A Prospective Study of 188 Patients.,"Purpose:  Palliative transurethral resection of the prostate (pTURP) in metastatic prostate cancer (mPCa) is reported to be rarely applied in clinics. We prospectively evaluated the ability of pTURP to achieve tumor control in patients with mPCa.  Patients and Methods:  A prospective study of patients with mPCa from 2011 to 2018 was conducted. The patients were divided into two groups: a pTURP + androgen deprivation therapy (ADT) group and an ADT group. Castration-resistant prostate cancer (CRPC)-free survival and cancer-specific survival (CSS) were analyzed as research endpoints between the groups using a Kaplan-Meier estimator.  Results:  A total of 188 patients with mPCa were enrolled in the study from our center, of which 110 patients were in the pTURP + ADT group, and 78 patients were in the ADT group. The basic clinical characteristics were comparable between the groups. There were no reoperations or severe complications in the pTURP + ADT group. The median follow-up was 29 months. The median CRPC-free survival was significantly increased when the 7-month prostate-specific antigen (PSA) was <4 ng/mL (34  vs  6,  p  < 0.01) and bone metastasis was ≤5 (25  vs  10,  p  < 0.01) but not in the pTURP + ADT group (16  vs  12,  p  = 0.267). The 3-year CSS was higher in the pTURP + ADT group than that in the ADT group (95.9%  vs  64.9%,  p  = 0.004), as well as when the 7-month PSA was <4 ng/mL compared to ≥4 ng/mL (90.7%  vs  36.6%,  p  < 0.01) and when bone metastasis was ≤5 compared to >5 (82.2%  vs  63.2%,  p  < 0.01). In subgroup analysis, pTURP + ADT could significantly improve patients' CSS when PSA ≥65 ng/mL, Gleason Score (GS) ≥8, and bone metastasis ≤5.  Conclusions:  We used our center-based cancer database to analyze survival in patients with mPCa undergoing pTURP. In the study population, pTURP + ADT was indicated to benefit CSS and shown to be safe. Moreover, we suggest that mPCa patients with PSA ≥65 ng/mL, GS ≥8, and bone metastasis ≤5 may perform pTURP before ADT.",2019,"The 3-year CSS was higher in the pTURP + ADT group than that in the ADT group (95.9%  vs  64.9%,  p  = 0.004), as well as when the 7-month PSA was <4 ng/mL compared to ≥4 ","['patients with mPCa undergoing pTURP', 'Patients with Metastatic Prostate Cancer', 'patients with mPCa', 'metastatic prostate cancer (mPCa', 'patients with mPCa from 2011 to 2018 was conducted', '188 Patients', '188 patients with mPCa were enrolled in the study from our center, of which 110 patients were in the pTURP + ADT group, and 78 patients were in the ADT group']","['pTURP + ADT', 'pTURP', 'pTURP + androgen deprivation therapy (ADT) group and an ADT group', 'Palliative transurethral resection of the prostate (pTURP', 'Palliative Transurethral Resection of the Prostate']","['Castration-resistant prostate cancer (CRPC)-free survival and cancer-specific survival (CSS', 'median CRPC-free survival', 'reoperations or severe complications', '3-year CSS', 'bone metastasis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",188.0,0.0306528,"The 3-year CSS was higher in the pTURP + ADT group than that in the ADT group (95.9%  vs  64.9%,  p  = 0.004), as well as when the 7-month PSA was <4 ng/mL compared to ≥4 ","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Qu', 'Affiliation': 'Department of Urology, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Department of Urology, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Bijun', 'Initials': 'B', 'LastName': 'Lian', 'Affiliation': 'Department of Urology, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Zepeng', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': 'Department of Urology, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Zhenkai', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Urology, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Yinghao', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Urology, Changhai Hospital, Shanghai, China.'}]",Journal of endourology,['10.1089/end.2019.0108']
1578,31696644,"Effect of different pulse numbers of transcranial magnetic stimulation on motor cortex excitability: Single-blind, randomized cross-over design.","AIMS


We aimed to investigate the effect of different pulse numbers of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the motor cortex on cortical excitability in healthy participants.
METHODS


Fifteen healthy participants received 600 and 1200 pulses of 5-Hz rTMS on separate days in a random order. Stimulation (duration, 2 seconds and interval, 1 seconds) was delivered over the left primary motor cortex for the hand, at 90% of resting motor threshold (rMT). The rMT and motor evoked potential (MEP) were measured before stimulation, and at 0 and 30 minutes after rTMS.
RESULTS


No significant differences were observed between the two conditions for MEP (P = .919) or rMT (P = .266). Compared with baseline, MEP was increased significantly at 0 (P < .001) and 30 minutes (P < .001) after stimulation. After stimulation, rMT was decreased at 0 minute for the 600 and 1200 pulse conditions (P < .001), but had recovered by 30 minutes (P = .073).
CONCLUSION


Subthreshold 5-Hz rTMS increased motor cortex excitability in healthy humans. However, the number of pulses may exhibit a ceiling effect in that beyond a certain point, that is, increasing the number of pulses may exhibit no further increase in cortical excitability.",2019,No significant differences were observed between the two conditions for MEP (P = .919) or rMT (P = .266).,"['healthy participants', 'Fifteen healthy participants received 600 and 1200 pulses of', 'healthy humans']","['high-frequency repetitive transcranial magnetic stimulation (rTMS', '5-Hz rTMS', 'rTMS', 'Subthreshold 5-Hz', 'transcranial magnetic stimulation']","['MEP', 'cortical excitability', 'rMT', 'rMT and motor evoked potential (MEP', 'motor cortex excitability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0026607', 'cui_str': 'Somatomotor Areas'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}]",15.0,0.240525,No significant differences were observed between the two conditions for MEP (P = .919) or rMT (P = .266).,"[{'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Tang', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Chun-Yu', 'Initials': 'CY', 'LastName': 'Xuan', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Zu-Lin', 'Initials': 'ZL', 'LastName': 'Dou', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yu-Jie', 'Initials': 'YJ', 'LastName': 'Lan', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Hong-Mei', 'Initials': 'HM', 'LastName': 'Wen', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}]",CNS neuroscience & therapeutics,['10.1111/cns.13248']
1579,30998121,Efficacy and safety of 20% albumin fluid loading in healthy subjects: a comparison of four resuscitation fluids.,"Recently, buffered salt solutions and 20% albumin (small volume resuscitation) have been advocated as an alternative fluid for intravenous resuscitation. The relative comparative efficacy and potential adverse effects of these solutions have not been evaluated. In a randomized, double blind, cross-over study of six healthy male subjects we compared the pulmonary and hemodynamic effects of intravenous administration of 30 ml/kg of 0.9% saline, Hartmann's solution and 4% albumin, and 6 ml/kg of 20% albumin (albumin dose equivalent). Lung tests (spirometry, ultrasound, impulse oscillometry, diffusion capacity, and plethysmography), two- to three-dimensional Doppler echocardiography, carotid applanation tonometry, blood gases, serum/urine markers of endothelial, and kidney injury were measured before and after each fluid bolus. Data were analyzed with repeated measures ANOVA with effect of fluid type examined as an interaction. Crystalloids caused lung edema [increase in ultrasound B line ( P  = 0.006) and airway resistance ( P  = 0.009)], but evidence of lung injury [increased angiopoietin-2 ( P  = 0.019)] and glycocalyx injury [increased syndecan ( P  = 0.026)] was only observed with 0.9% saline. The colloids caused greater left atrial stretch, decrease in lung volumes, and increase in diffusion capacity than the crystalloids, but without pulmonary edema. Stroke work increased proportionally to increase in preload with all four fluids ( R 2  = 0.71). There was a greater increase in cardiac output and stroke volume after colloid administration, associated with a reduction in afterload. Hartmann's solution did not significantly alter ventricular performance. Markers of kidney injury were not affected by any of the fluids administrated. Bolus administration of 20% albumin is both effective and safe in healthy subjects.  NEW & NOTEWORTHY  Bolus administration of 20% albumin is both effective and safe in healthy subjects when compared with other commonly available crystalloids and colloidal solution.",2019,"The colloids caused greater left atrial stretch, decrease in lung volumes, and increase in diffusion capacity than the crystalloids, but without pulmonary edema.","['six healthy male subjects', 'healthy subjects']","['buffered salt solutions and 20% albumin (small volume resuscitation', '20% albumin', '20% albumin fluid loading', ""intravenous administration of 30 ml/kg of 0.9% saline, Hartmann's solution and 4% albumin, and 6 ml/kg of 20% albumin (albumin dose equivalent""]","['lung volumes', 'Lung tests (spirometry, ultrasound, impulse oscillometry, diffusion capacity, and plethysmography), two- to three-dimensional Doppler echocardiography, carotid applanation tonometry, blood gases, serum/urine markers of endothelial, and kidney injury', 'airway resistance', 'afterload', 'diffusion capacity', 'cardiac output and stroke volume', 'Efficacy and safety', 'left atrial stretch', 'lung edema', 'ventricular performance', 'ultrasound B line', 'glycocalyx injury [increased syndecan']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3653289', 'cui_str': 'Salt irrigating solutions'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0013125'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]","[{'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0029375', 'cui_str': 'Oscillometry'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0013520', 'cui_str': 'Echocardiography, Doppler'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry (procedure)'}, {'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042037'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0034063', 'cui_str': 'Wet Lung'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0061622', 'cui_str': 'Cell Coat'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0075691'}]",6.0,0.197963,"The colloids caused greater left atrial stretch, decrease in lung volumes, and increase in diffusion capacity than the crystalloids, but without pulmonary edema.","[{'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre , Bedford Park, South Australia , Australia.'}, {'ForeName': 'Ubbo F', 'Initials': 'UF', 'LastName': 'Wiersema', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre , Bedford Park, South Australia , Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Perry', 'Affiliation': 'College of Medicine and Public Health, Flinders University , Adelaide, South Australia , Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schembri', 'Affiliation': 'Department of Respiratory Medicine, Flinders Medical Centre , Bedford Park, South Australia , Australia.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Bouchier', 'Affiliation': 'College of Medicine and Public Health, Flinders University , Adelaide, South Australia , Australia.'}, {'ForeName': 'Dani', 'Initials': 'D', 'LastName': 'Dixon', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre , Bedford Park, South Australia , Australia.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Wong', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre , Bedford Park, South Australia , Australia.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Bersten', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre , Bedford Park, South Australia , Australia.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.01058.2018']
1580,30998125,"Effects of short-term sprint interval and moderate-intensity continuous training on liver fat content, lipoprotein profile, and substrate uptake: a randomized trial.","Type 2 diabetes (T2D) and increased liver fat content (LFC) alter lipoprotein profile and composition and impair liver substrate uptake. Exercise training mitigates T2D and reduces LFC, but the benefits of different training intensities in terms of lipoprotein classes and liver substrate uptake are unclear. The aim of this study was to evaluate the effects of moderate-intensity continuous training (MICT) or sprint interval training (SIT) on LFC, liver substrate uptake, and lipoprotein profile in subjects with normoglycemia or prediabetes/T2D. We randomized 54 subjects (normoglycemic group,  n  = 28; group with prediabetes/T2D,  n  = 26; age = 40-55 yr) to perform either MICT or SIT for 2 wk and measured LFC with magnetic resonance spectroscopy, lipoprotein composition with NMR, and liver glucose uptake (GU) and fatty acid uptake (FAU) using PET. At baseline, the group with prediabetes/T2D had higher LFC, impaired lipoprotein profile, and lower whole body insulin sensitivity and aerobic capacity compared with the normoglycemic group. Both training modes improved aerobic capacity ( P  < 0.001) and lipoprotein profile (reduced LDL and increased large HDL subclasses; all  P  < 0.05) with no training regimen (SIT vs. MICT) or group effect (normoglycemia vs. prediabetes/T2D). LFC tended to be reduced in the group with prediabetes/T2D compared with the normoglycemic group posttraining ( P  = 0.051). When subjects were divided according to LFC (high LFC, >5.6%; low LFC, <5.6%), training reduced LFC in subjects with high LFC ( P  = 0.009), and only MICT increased insulin-stimulated liver GU ( P  = 0.03). Short-term SIT and MICT are effective in reducing LFC in subjects with fatty liver and in improving lipoprotein profile regardless of baseline glucose tolerance. Short-term MICT is more efficient in improving liver insulin sensitivity compared with SIT.  NEW & NOTEWORTHY  In the short term, both sprint interval training and moderate-intensity continuous training (MICT) reduce liver fat content and improve lipoprotein profile; however, MICT seems to be preferable in improving liver insulin sensitivity.",2019,Both training modes improved aerobic capacity ( P  < 0.001) and lipoprotein profile (reduced LDL and increased large HDL subclasses; all  P  < 0.05) with no training regimen (SIT vs. MICT) or group effect (normoglycemia vs. prediabetes/T2D).,"['54 subjects (normoglycemic group,  n  = 28; group with prediabetes/T2D,  n  = 26; age\u2009=\u200940-55 yr', 'subjects with normoglycemia or prediabetes']","['short-term sprint interval and moderate-intensity continuous training', 'sprint interval training and moderate-intensity continuous training (MICT', 'moderate-intensity continuous training (MICT) or sprint interval training (SIT', 'MICT or SIT']","['Type 2 diabetes (T2D) and increased liver fat content (LFC) alter lipoprotein profile and composition and impair liver substrate uptake', 'LFC, liver substrate uptake, and lipoprotein profile', 'lipoprotein composition with NMR, and liver glucose uptake (GU) and fatty acid uptake (FAU', 'LFC', 'aerobic capacity', 'liver insulin sensitivity', 'lipoprotein profile (reduced LDL and increased large HDL subclasses', 'MICT increased insulin-stimulated liver GU', 'liver fat content, lipoprotein profile, and substrate uptake', 'higher LFC, impaired lipoprotein profile, and lower whole body insulin sensitivity and aerobic capacity']","[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0445604', 'cui_str': 'Subclass (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}]",54.0,0.0301251,Both training modes improved aerobic capacity ( P  < 0.001) and lipoprotein profile (reduced LDL and increased large HDL subclasses; all  P  < 0.05) with no training regimen (SIT vs. MICT) or group effect (normoglycemia vs. prediabetes/T2D).,"[{'ForeName': 'Kumail K', 'Initials': 'KK', 'LastName': 'Motiani', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Savolainen', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Toivanen', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Jari-Joonas', 'Initials': 'JJ', 'LastName': 'Eskelinen', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Yli-Karjanmaa', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Kirsi A', 'Initials': 'KA', 'LastName': 'Virtanen', 'Affiliation': 'Turku PET Centre, Turku University Hospital , Turku , Finland.'}, {'ForeName': 'Virva', 'Initials': 'V', 'LastName': 'Saunavaara', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Marja A', 'Initials': 'MA', 'LastName': 'Heiskanen', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Parkkola', 'Affiliation': 'Department of Radiology, Turku University Hospital , Turku , Finland.'}, {'ForeName': 'Merja', 'Initials': 'M', 'LastName': 'Haaparanta-Solin', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Solin', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Savisto', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Eliisa', 'Initials': 'E', 'LastName': 'Löyttyniemi', 'Affiliation': 'Department of Biostatistics, University of Turku , Turku , Finland.'}, {'ForeName': 'Juhani', 'Initials': 'J', 'LastName': 'Knuuti', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Nuutila', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Kari K', 'Initials': 'KK', 'LastName': 'Kalliokoski', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}, {'ForeName': 'Jarna C', 'Initials': 'JC', 'LastName': 'Hannukainen', 'Affiliation': 'Turku PET Centre, University of Turku , Turku , Finland.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00900.2018']
1581,30975570,"Immunogenicity of pneumococcal conjugate vaccine formulations containing pneumococcal proteins, and immunogenicity and reactogenicity of co-administered routine vaccines - A phase II, randomised, observer-blind study in Gambian infants.","BACKGROUND


Two conserved pneumococcal proteins, pneumolysin toxoid (dPly) and pneumococcal histidine triad protein D (PhtD), combined with 10 polysaccharide conjugates from the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) in two investigational pneumococcal vaccine (PHiD-CV/dPly/PhtD) formulations were immunogenic and well-tolerated when administered to Gambian children. Here, we report immunogenicity of the polysaccharide conjugates, and immunogenicity and reactogenicity of co-administered routine vaccines.
METHODS


In this phase II, controlled, observer-blind, single-centre study, healthy infants aged 8-10 weeks were randomised (1:1:1:1:1:1) to six groups. Four groups received 3+0 schedule (2-3-4 months [M]) of PHiD-CV/dPly/PhtD (10 or 30 µg of each protein), PHiD-CV, or 13-valent pneumococcal conjugate vaccine; and two groups received 2+1 schedule (2-4-9 M) of PHiD-CV/dPly/PhtD (30 µg of each protein) or PHiD-CV. All infants received diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b (DTPw-HBV/Hib) and oral trivalent polio vaccines (OPV) at 2-3-4 M, and measles, yellow fever, and OPV vaccines at 9 M. We evaluated immune responses at 2-5-9-12 M; and reactogenicity 0-3 days post-vaccination.
RESULTS


1200 infants were enrolled between June 2011 and May 2012; 1152 completed the study. 1 M post-primary vaccination, for each PHiD-CV serotype except 6B and 23F, ≥97.4% (3+0 schedule) and ≥96.4% (2+1 schedule) of infants had antibody concentrations ≥0.2 μg/mL. Immune responses were comparable between groups within the same vaccination schedules. Observed antibody geometric mean concentrations (GMCs) increased by 1 M post-primary vaccination compared to pre-vaccination. In the following months, GMCs and opsonophagocytic activity titres waned, with an increase post-booster for the 2+1 schedule. Immune responses to protein D and, DTPw-HBV/Hib, OPV, measles, and yellow fever vaccines were not altered by co-administration with pneumococcal proteins. Reactogenicity of co-administered vaccines was comparable between groups and did not raise concerns.
CONCLUSION


Immune responses to the 10 PHiD-CV polysaccharide conjugates and co-administered vaccines were not altered by addition of dPly and PhtD. ClinicalTrials.gov identifier NCT01262872.",2019,"In the following months, GMCs and opsonophagocytic activity titres waned, with an increase post-booster for the 2+1 schedule.","['Gambian infants', '1200 infants were enrolled between June 2011 and May 2012; 1152 completed the study', 'healthy infants aged 8-10\u202fweeks']","['PHiD-CV/dPly/PhtD (10 or 30\u202fµg of each protein), PHiD-CV, or 13-valent pneumococcal conjugate vaccine', 'diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b (DTPw-HBV/Hib) and oral trivalent polio vaccines (OPV', 'PHiD-CV/dPly/PhtD (30\u202fµg of each protein) or PHiD-CV', 'pneumolysin toxoid (dPly) and pneumococcal histidine triad protein D (PhtD']","['GMCs and opsonophagocytic activity titres', 'Reactogenicity', 'antibody geometric mean concentrations (GMCs', 'immunogenicity and reactogenicity']","[{'cui': 'C0337833', 'cui_str': 'Gambians (ethnic group)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}, {'cui': 'C0071313', 'cui_str': 'plY protein, Streptococcus pneumoniae'}, {'cui': 'C0040555', 'cui_str': 'Toxoids'}, {'cui': 'C0385592', 'cui_str': 'histidine triad protein'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",1200.0,0.103678,"In the following months, GMCs and opsonophagocytic activity titres waned, with an increase post-booster for the 2+1 schedule.","[{'ForeName': 'Aderonke', 'Initials': 'A', 'LastName': 'Odutola', 'Affiliation': 'Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: aderonke.odutola@lshtm.ac.uk.'}, {'ForeName': 'Martin O C', 'Initials': 'MOC', 'LastName': 'Ota', 'Affiliation': 'Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: martin.x.ota@gsk.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Antonio', 'Affiliation': 'Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: mantonio@mrc.gm.'}, {'ForeName': 'Ezra O', 'Initials': 'EO', 'LastName': 'Ogundare', 'Affiliation': 'Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: tundeyogundare@yahoo.com.'}, {'ForeName': 'Yauba', 'Initials': 'Y', 'LastName': 'Saidu', 'Affiliation': 'Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: ysaidu@clintonhealthaccess.org.'}, {'ForeName': 'Patrick K', 'Initials': 'PK', 'LastName': 'Owiafe', 'Affiliation': 'Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: pkowiafe@uhas.edu.gh.'}, {'ForeName': 'Archibald', 'Initials': 'A', 'LastName': 'Worwui', 'Affiliation': 'Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: aworwui@mrc.gm.'}, {'ForeName': 'Olubukola T', 'Initials': 'OT', 'LastName': 'Idoko', 'Affiliation': 'Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: oidoko@mrc.gm.'}, {'ForeName': 'Olumuyiwa', 'Initials': 'O', 'LastName': 'Owolabi', 'Affiliation': 'Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia. Electronic address: oowolabi@mrc.gm.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Kampmann', 'Affiliation': 'Vaccines & Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia; Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: bkampmann@mrc.gm.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Greenwood', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: Brian.Greenwood@lshtm.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Alderson', 'Affiliation': 'PATH, Seattle, WA, USA. Electronic address: malderson@path.org.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Traskine', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: magali.x.traskine@gsk.com.'}, {'ForeName': 'Kristien', 'Initials': 'K', 'LastName': 'Swinnen', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: kristien.m.swinnen@gsk.com.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Verlant', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: vincent.verlant@gsk.com.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Dobbelaere', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: dobbelaerekurt@gmail.com.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Borys', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: dorota.d.borys@gsk.com.'}]",Vaccine,['10.1016/j.vaccine.2019.03.033']
1582,30734333,Letter to Editor: Role of Pharmacotherapy in Patients With Coexisting Nonalcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus.,"We read with interest a recent article written by Yan et al. (1)  The authors conducted a randomized trial in patients with coexisting type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD) to receive liraglutide, sitagliptin, or insulin glargine as add-on to metformin. The authors observed glycemic control and a reduction in body weight, intrahepatic lipid, and visceral adipose tissue in patients who received liraglutide or sitagliptin and then reported these add-on therapies to be novel pharmacotherapeutic therapies in patients with NAFLD and T2DM. However, the clinical meaningfulness of these pharmacologic treatments has not been conclusively established, especially since histopathology was not used to diagnose and determine the severity of NAFLD in that study. This article is protected by copyright. All rights reserved.",2019,"The authors observed glycemic control and a reduction in body weight, intrahepatic lipid, and visceral adipose tissue in patients who received liraglutide or sitagliptin and then reported these add-on therapies to be novel pharmacotherapeutic therapies in patients with NAFLD and T2DM.","['patients with coexisting type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD) to receive', 'Patients With Coexisting Nonalcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus', 'patients with NAFLD and T2DM']","['Pharmacotherapy', 'liraglutide, sitagliptin, or insulin glargine as add-on to metformin', 'liraglutide or sitagliptin']","['body weight, intrahepatic lipid, and visceral adipose tissue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}]",,0.0149318,"The authors observed glycemic control and a reduction in body weight, intrahepatic lipid, and visceral adipose tissue in patients who received liraglutide or sitagliptin and then reported these add-on therapies to be novel pharmacotherapeutic therapies in patients with NAFLD and T2DM.","[{'ForeName': 'Sikarin', 'Initials': 'S', 'LastName': 'Upala', 'Affiliation': 'Department of Preventive and Social Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30551']
1583,31005431,Comparison of Anterior-Stabilized and Posterior-Stabilized Total Knee Arthroplasty in the Same Patients: A Prospective Randomized Study.,"BACKGROUND


A highly conforming, anterior-stabilized (AS) insert is designed to provide anteroposterior (AP) stability of the posterior-stabilized (PS) insert without a post. The purpose of this study was to compare the static and dynamic stability and function of AS and PS total knee arthroplasty (TKA) in the same patients.
METHODS


A prospective, randomized controlled trial was performed in 45 patients scheduled to undergo same-day bilateral TKA. One knee was randomly assigned to receive an AS TKA, and the other knee was scheduled for a PS TKA from the same knee system. At 2 years postoperatively, the static AP stability was compared using anterior and posterior drawer stress radiographs at 90° knee flexion. Dynamic AP stability was evaluated using one-leg standing lateral fluoroscopic images throughout the range of motion. Knee function was compared using the Knee Society Score and Western Ontario and McMaster Universities Osteoarthritis Index score.
RESULTS


At 2 years postoperatively, there was a significant difference in knee AP laxity at 90° of flexion between the two groups (7.6 ± 3.9 mm in the AS group vs 2.2 ± 2.3 in the PS group, P < .001). However, there were no differences in dynamic AP stability under one-leg standing fluoroscopic lateral images at 30°, 60°, and 90° knee flexion (P = .732, P = .764, and P = .679, respectively). The Knee Society Score and Western Ontario and McMaster Universities Osteoarthritis Index scores were not significantly different between the two groups (P = .641 and P = .582, respectively).
CONCLUSION


Despite the fact that the AS TKA group showed significantly more static posterior displacement than the PS TKA group at 90° of knee flexion, both the AS and PS TKA groups showed similar dynamic stability under weight-bearing conditions and knee function at 2 years postoperatively.",2019,"The Knee Society Score and Western Ontario and McMaster Universities Osteoarthritis Index scores were not significantly different between the two groups (P = .641 and P = .582, respectively).
","['Same Patients', 'same patients', '45 patients scheduled to undergo same-day bilateral TKA']","['Anterior-Stabilized and Posterior-Stabilized Total Knee Arthroplasty', 'AS TKA', 'PS TKA']","['Knee function', 'Knee Society Score and Western Ontario and McMaster Universities Osteoarthritis Index score', 'dynamic stability under weight-bearing conditions and knee function', 'knee AP laxity', 'dynamic AP stability under one-leg standing fluoroscopic lateral images', 'static posterior displacement', 'Knee Society Score and Western Ontario and McMaster Universities Osteoarthritis Index scores', 'static and dynamic stability and function of AS and PS total knee arthroplasty (TKA', 'static AP stability', 'Dynamic AP stability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0333044', 'cui_str': 'Posterior displacement (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]",45.0,0.0336349,"The Knee Society Score and Western Ontario and McMaster Universities Osteoarthritis Index scores were not significantly different between the two groups (P = .641 and P = .582, respectively).
","[{'ForeName': 'Sung W', 'Initials': 'SW', 'LastName': 'Jang', 'Affiliation': 'Department of Orthopaedic Surgery, Chakhan Madi Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Man S', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'In J', 'Initials': 'IJ', 'LastName': 'Koh', 'Affiliation': ""Department of Orthopaedic Surgery, St. Paul's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Sueen', 'Initials': 'S', 'LastName': 'Sohn', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Chulkyu', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'In', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",The Journal of arthroplasty,['10.1016/j.arth.2019.03.062']
1584,30905721,The effect of resistance exercise upon age-related systemic and local skeletal muscle inflammation.,"AIM


Chronic inflammation increases with age and is correlated positively to visceral fat mass, but inversely to muscle mass. We investigated the hypothesis that resistance training would increase muscle mass and strength together with a concomitant drop in local and systemic inflammation level independent of any changes in visceral fat tissue in elderly.
METHODS


25 subjects (mean 67, range 62-70 years) were randomized to 1 year of heavy resistance training (HRT) or control (CON), and tested at 0, 4 and 12 months for physical performance, body composition (DXA), vastus lateralis muscle area (MRI) local and systemic inflammation (blood and muscle). In addition, systemic and local muscle immunological responses to acute exercise was determined before and after the training period.
RESULTS


Increases in muscle mass (≈2%, p < 0.05), vastus lateralis area (≈9%. P < 0.05), isometric (≈15%) and dynamic (≈15%) muscle strength (p < 0.05) were found in the HRT group after 12 months training. HRT did not alter overall or visceral fat mass (p > 0.05). Blood C-Reactive Protein declined over time in both groups (p < 0.05), whereas muscle inflammation markers were unchanged to 1 year of HRT. Acute exercise increased plasma IL-6 and FGF-19 (p < 0.05), decreased FGF-21 (p < 0.05) and CCL-20 (p < 0.05), and increased GDNF in muscle (p < 0.001) similarly before and after 1 year in both groups.
CONCLUSION


Long term resistance training increased muscle strength and improved muscle mass, but did not alter visceral fat mass and did not show any specific effect upon resting or exercise induced markers of inflammation.",2019,"Acute exercise increased plasma IL-6 and FGF-19 (p < 0.05), decreased FGF-21 (p < 0.05) and CCL-20 (p < 0.05), and increased GDNF in muscle (p < 0.001) similarly before and after 1 year in both groups.
","['25 subjects (mean 67, range 62-70\u202fyears']","['resistance exercise', 'resistance training', 'HRT', 'heavy resistance training (HRT) or control (CON']","['Blood C-Reactive Protein', 'muscle strength and improved muscle mass', 'GDNF in muscle', 'body composition (DXA), vastus lateralis muscle area (MRI) local and systemic inflammation (blood and muscle', 'muscle strength', 'muscle inflammation markers', 'CCL-20', 'muscle mass', 'isometric', 'FGF-21', 'plasma IL-6 and FGF-19', 'overall or visceral fat mass', 'vastus lateralis area']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0005768'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0207072', 'cui_str': 'Glial Cell Line-Derived Neurotrophic Factor'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0224444', 'cui_str': 'Vastus Lateralis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0027121', 'cui_str': 'Inflammatory Myopathy'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.0367706,"Acute exercise increased plasma IL-6 and FGF-19 (p < 0.05), decreased FGF-21 (p < 0.05) and CCL-20 (p < 0.05), and increased GDNF in muscle (p < 0.001) similarly before and after 1 year in both groups.
","[{'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Ziegler', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery M, Bispebjerg Hospital and Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark. Electronic address: Andreas.Kraag.Ziegler@regionh.dk.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Jensen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery M, Bispebjerg Hospital and Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schjerling', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery M, Bispebjerg Hospital and Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Mackey', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery M, Bispebjerg Hospital and Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Department of Biomedical Sciences, Faculty of Healthy and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Andersen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery M, Bispebjerg Hospital and Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kjaer', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery M, Bispebjerg Hospital and Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}]",Experimental gerontology,['10.1016/j.exger.2019.03.007']
1585,30965213,Prophylactic antibiotics reduce hospitalisations and cost in locally advanced head and neck cancer patients treated with chemoradiotherapy: A randomised phase 2 study.,"BACKGROUND


Platinum-based chemoradiotherapy for locally advanced head and neck cancer (LAHNC) induces a high rate of acute toxicity, including dysphagia and aspiration pneumonia. We hypothesised that prophylactic antibiotics can prevent pneumonia and hospitalisations and can be cost-effective.
PATIENT AND METHODS


In this multicentre randomised trial, patients with LAHNC treated with chemoradiotherapy received prophylactic amoxicillin/clavulanic acid from day 29 after the start of treatment until 14 days after completion of chemoradiotherapy or standard care without prophylaxis. The primary objective was to observe a reduction in pneumonias. Secondary objectives were to evaluate the hospitalisation rate, adverse events, costs and health-related quality of life.
RESULTS


One hundred six patients were included; of which, 95 were randomised: 48 patients were allocated to the standard group and 47 patients to the prophylaxis group. A pneumonia during chemoradiotherapy and follow-up until 3.5 months was observed in 22 (45.8%) of 48 patients in the standard group and in 22 (46.8%) of 47 patients in the prophylaxis group (p = 0.54). Hospitalisation rate was significantly higher in the standard group versus the prophylaxis group, 19 of 48 pts (39.6%) versus 9 of 47 pts (19.1%), respectively (p = 0.03). Significantly more episodes with fever of any grade were observed in the standard group (29.2% vs 10.2%, p = 0.028). A significant difference in costs was found, with an average reduction of €1425 per patient in favour of the prophylaxis group.
CONCLUSION


Although prophylactic antibiotics during chemoradiotherapy for patients with LAHNC did not reduce the incidence of pneumonias, it did reduce hospitalisation rates and episodes with fever significantly and consequently tended to be cost-effective.",2019,"A significant difference in costs was found, with an average reduction of €1425 per patient in favour of the prophylaxis group.
","['One hundred six patients were included; of which, 95 were randomised: 48 patients were allocated to the standard group and 47 patients to the prophylaxis group', 'locally advanced head and neck cancer patients treated with', 'patients with LAHNC treated with', 'locally advanced head and neck cancer (LAHNC']","['prophylactic antibiotics', 'Platinum-based chemoradiotherapy', 'chemoradiotherapy or standard care without prophylaxis', 'chemoradiotherapy received prophylactic amoxicillin/clavulanic acid', 'chemoradiotherapy', 'Prophylactic antibiotics']","['hospitalisation rate, adverse events, costs and health-related quality of life', 'pneumonias', 'Hospitalisation rate', 'episodes with fever of any grade', 'costs', 'hospitalisation rates and episodes with fever']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055860', 'cui_str': 'Clavulanic Acid'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",106.0,0.12302,"A significant difference in costs was found, with an average reduction of €1425 per patient in favour of the prophylaxis group.
","[{'ForeName': 'Janneke C', 'Initials': 'JC', 'LastName': 'Ham', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Chantal M', 'Initials': 'CM', 'LastName': 'Driessen', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Mathijs P', 'Initials': 'MP', 'LastName': 'Hendriks', 'Affiliation': 'Department of Internal Medicine, Northwest Clinics, Alkmaar, The Netherlands.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Fiets', 'Affiliation': 'Department of Internal Medicine, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Kreike', 'Affiliation': 'Department of Radiation Oncology, Radiotherapeutic Institute Arnhem, Arnhem, The Netherlands.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hoeben', 'Affiliation': 'Department of Medical Oncology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Slingerland', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Claudia C', 'Initials': 'CC', 'LastName': 'van Opstal', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Bart Jan', 'Initials': 'BJ', 'LastName': 'Kullberg', 'Affiliation': 'Department of Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Marianne A', 'Initials': 'MA', 'LastName': 'Jonker', 'Affiliation': 'Biostatistics, Radboud Institute for Health Sciences, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Eddy M', 'Initials': 'EM', 'LastName': 'Adang', 'Affiliation': 'Biostatistics, Radboud Institute for Health Sciences, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Johannes H', 'Initials': 'JH', 'LastName': 'Kaanders', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Winette T', 'Initials': 'WT', 'LastName': 'van der Graaf', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'van Herpen', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Postbox 9101, 6500 HB, Nijmegen, The Netherlands. Electronic address: Carla.vanHerpen@radboudumc.nl.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.02.013']
1586,30955982,Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants.,"BACKGROUND


A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil®) was licensed in 2016. A liquid formulation of this vaccine (LBRV-PV, Rotasiil - Liquid) was subsequently developed and was tested for non-inferiority to Rotasiil® and for lot-to-lot consistency.
METHODS


This Phase II/III, open label, randomized study was conducted at seven sites across India from November 2017 to June 2018. Participants were randomized into four arms; Lots A, B, and C of LBRV-PV and Rotasiil® in 1:1:1:1 ratio. Three doses of study vaccines were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. Non-inferiority of LBRV-PV to Rotasiil was proven if the lower limit two-sided 95% confidence interval (CI) of geometric mean concentration (GMC) ratio was at least 0.5. Lot-to-lot consistency was proven if 95% CI of the GMC ratios of three lots were between 0.5 and 2. Solicited reactions were collected by using diary cards.
RESULTS


Of the 1500 randomized infants, 1436 infants completed the study. The IgA GMC ratio of LBRV-PV to Rotasiil® was 1.19 (95% CI 0.96, 1.48). The corresponding IgA seropositivity rates were 60.41% (57.41, 63.35) and 52.75% (47.48, 57.97). The IgA GMC ratios among the three LBRV-PV lots were: Lot A versus Lot B: 1.34 (1.03, 1.75); Lot A versus Lot C: 1.22 (0.93, 1.60); and Lot B versus Lot C: 0.91 (0.69, 1.19). The 95% CIs for the GMC ratios were between 0.69 and 1.75. The incidence of solicited reactions was comparable across the four arms. Only one serious adverse event of gastroenteritis event in the Rotasiil® group was causally related.
CONCLUSION


The immunological non-inferiority of LBRV-PV against Rotasiil® as well as lot-to-lot consistency of LBRV-PV was demonstrated. LBRV-PV had safety profile similar to Rotasiil®.
TRIAL REGISTRATION NUMBER


Clinical Trials.Gov [NCT03474055] and Clinical Trial Registry of India [CTRI/2017/10/010104].",2019,"The corresponding IgA seropositivity rates were 60.41% (57.41, 63.35) and 52.75% (47.48, 57.97).","['1436 infants completed the study', '1500 randomized infants', 'This Phase II/III, open label, randomized study was conducted at seven sites across India from November 2017 to June 2018', 'Indian infants']","['vaccine (LBRV-PV, Rotasiil - Liquid', 'lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil®', 'liquid bovine-human reassortant pentavalent rotavirus vaccine']","['incidence of solicited reactions', 'GMC ratios', 'serious adverse event of gastroenteritis event', 'geometric mean concentration (GMC) ratio', 'IgA GMC ratio of LBRV-PV to Rotasiil®', 'rotavirus IgA antibody levels', 'corresponding IgA seropositivity rates', 'IgA GMC ratios']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0318711', 'cui_str': 'Human rotavirus (organism)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2713569', 'cui_str': 'pentavalent rotavirus vaccine (RV5)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C3476459', 'cui_str': 'Rotavirus IgA'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",1500.0,0.142233,"The corresponding IgA seropositivity rates were 60.41% (57.41, 63.35) and 52.75% (47.48, 57.97).","[{'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Kawade', 'Affiliation': 'Vadu Rural Health Program, KEM Hospital Research Centre, Vadu, Pune, India.'}, {'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Babji', 'Affiliation': 'The Wellcome Trust Research Laboratory, Christian Medical College Vellore, India.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Kamath', 'Affiliation': 'Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Raut', 'Affiliation': 'Mahatma Gandhi Institute of Medical Sciences, Sevagram, India.'}, {'ForeName': 'Chandra Mohan', 'Initials': 'CM', 'LastName': 'Kumar', 'Affiliation': 'Hamdard Institute of Medical Sciences and Research, Delhi, India.'}, {'ForeName': 'Ritabrata', 'Initials': 'R', 'LastName': 'Kundu', 'Affiliation': 'Institute of Child Health Kolkata, India.'}, {'ForeName': 'Padmasani', 'Initials': 'P', 'LastName': 'Venkatramanan', 'Affiliation': 'Sri Ramachandra Medical Centre, Chennai, India.'}, {'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Lalwani', 'Affiliation': 'Bharati Vidyapeeth Medical College & Hospital, Pune, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bavdekar', 'Affiliation': 'Vadu Rural Health Program, KEM Hospital Research Centre, Vadu, Pune, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Juvekar', 'Affiliation': 'Vadu Rural Health Program, KEM Hospital Research Centre, Vadu, Pune, India.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Dayma', 'Affiliation': 'Vadu Rural Health Program, KEM Hospital Research Centre, Vadu, Pune, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Patil', 'Affiliation': 'Vadu Rural Health Program, KEM Hospital Research Centre, Vadu, Pune, India.'}, {'ForeName': 'Muralidhar', 'Initials': 'M', 'LastName': 'Kulkarni', 'Affiliation': 'Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Hegde', 'Affiliation': 'Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Nayak', 'Affiliation': 'Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Garg', 'Affiliation': 'Mahatma Gandhi Institute of Medical Sciences, Sevagram, India.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Mahatma Gandhi Institute of Medical Sciences, Sevagram, India.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Jategaonkar', 'Affiliation': 'Mahatma Gandhi Institute of Medical Sciences, Sevagram, India.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Bedi', 'Affiliation': 'Hamdard Institute of Medical Sciences and Research, Delhi, India.'}, {'ForeName': 'Chetna', 'Initials': 'C', 'LastName': 'Maliye', 'Affiliation': 'Mahatma Gandhi Institute of Medical Sciences, Sevagram, India.'}, {'ForeName': 'Nupur', 'Initials': 'N', 'LastName': 'Ganguly', 'Affiliation': 'Institute of Child Health Kolkata, India.'}, {'ForeName': 'Kheya Ghosh', 'Initials': 'KG', 'LastName': 'Uttam', 'Affiliation': 'Institute of Child Health Kolkata, India.'}, {'ForeName': 'Prabal', 'Initials': 'P', 'LastName': 'Niyogi', 'Affiliation': 'Institute of Child Health Kolkata, India.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Palkar', 'Affiliation': 'Bharati Vidyapeeth Medical College & Hospital, Pune, India.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Hanumante', 'Affiliation': 'Bharati Vidyapeeth Medical College & Hospital, Pune, India.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Goyal', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, Delhi, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Arya', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, Delhi, India.'}, {'ForeName': 'Mohd', 'Initials': 'M', 'LastName': 'Aslam', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, Delhi, India.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Parulekar', 'Affiliation': 'DiagnoSearch Life Sciences Pvt Ltd, Mumbai, India.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Dharmadhikari', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Dutta', 'Initials': 'D', 'LastName': 'Gaikwad', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Jagdish', 'Initials': 'J', 'LastName': 'Zade', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Gagandeep', 'Initials': 'G', 'LastName': 'Kang', 'Affiliation': 'The Wellcome Trust Research Laboratory, Christian Medical College Vellore, India.'}, {'ForeName': 'Prasad S', 'Initials': 'PS', 'LastName': 'Kulkarni', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India. Electronic address: drpsk@seruminstitute.com.'}]",Vaccine,['10.1016/j.vaccine.2019.03.067']
1587,30992195,"Albuminuria-lowering effect of dapagliflozin alone and in combination with saxagliptin and effect of dapagliflozin and saxagliptin on glycaemic control in patients with type 2 diabetes and chronic kidney disease (DELIGHT): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


In patients with type 2 diabetes, intensive glucose control can be renoprotective and albuminuria-lowering treatments can slow the deterioration of kidney function. We assessed the albuminuria-lowering effect of the sodium-glucose co-transporter-2 inhibitor dapagliflozin with and without the dipeptidyl peptidase-4 inhibitor saxagliptin, and the effect of dapagliflozin-saxagliptin on glycaemic control in patients with type 2 diabetes and moderate-to-severe chronic kidney disease.
METHODS


In this double-blind, placebo-controlled trial (DELIGHT), we enrolled patients at 116 research centres in Australia, Canada, Japan, South Korea, Mexico, South Africa, Spain, Taiwan, and the USA. We included patients with a known history of type 2 diabetes, increased albuminuria (urine albumin-to-creatinine ratio [UACR] 30-3500 mg/g), an estimated glomerular filtration rate of 25-75 mL/min per 1·73 m 2 , and an HbA 1c  of 7·0-11·0% (53-97 mmol/mol), who had been receiving stable doses of angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker therapy and glucose-lowering treatment for at least 12 weeks. After a 4-week, single-blind placebo run-in period, participants were randomly assigned (1:1:1; via an interactive voice-web response system) to receive dapagliflozin (10 mg) only, dapagliflozin (10 mg) and saxagliptin (2·5 mg), or placebo once-daily for 24 weeks. Primary endpoints were change from baseline in UACR (dapagliflozin and dapagliflozin-saxagliptin groups) and HbA 1c  (dapagliflozin-saxagliptin group) at week 24 in all randomly allocated patients with available data (full analysis set). This study is registered with ClinicalTrials.gov, number NCT02547935 and is completed.
FINDINGS


The study took place between July 14, 2015, and May 18, 2018. 1187 patients were screened, of whom 461 were randomly assigned: 145 to the dapagliflozin group, 155 to the dapagliflozin-saxagliptin group, and 148 to the placebo group (13 patients were excluded because of data integrity issues). Dapagliflozin and dapagliflozin-saxagliptin reduced UACR versus placebo throughout the study period. At week 24, the difference (vs placebo; n=134 patients with available data) in mean UACR change from baseline was -21·0% (95% CI -34·1 to -5·2; p=0·011) for dapagliflozin (n=132) and -38·0% (-48·2 to -25·8; p<0·0001) for dapagliflozin-saxagliptin (n=139). HbA 1c  was reduced in the dapagliflozin-saxagliptin group (n=137) compared with the placebo group (n=118) at week 24 (-0·58% [-0·80 to -0·37; p<0·0001]). The numbers of patients with adverse events (79 [54%] in the dapagliflozin group, 104 [68%] in the dapagliflozin-saxagliptin group, and 81 [55%] in the placebo group) or serious adverse events (12 [8%], 12 [8%], and 16 [11%], respectively) were similar across groups. There were no new drug-related safety signals.
INTERPRETATION


Dapagliflozin with or without saxagliptin, given in addition to angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker treatment, is a potentially attractive option to slow the progression of kidney disease in patients with type 2 diabetes and moderate-to-severe chronic kidney disease.
FUNDING


AstraZeneca.",2019,HbA 1c  was reduced in the dapagliflozin-saxagliptin group (n=137) compared with the placebo group (n=118) at week 24 (-0·58% [-0·80 to -0·37; p<0·0001]).,"['1187 patients were screened, of whom 461 were randomly assigned: 145 to the', 'patients with a known history of type 2 diabetes, increased albuminuria (urine albumin-to-creatinine ratio [UACR] 30-3500 mg/g), an estimated glomerular filtration rate of 25-75 mL/min per 1·73 m 2 , and an HbA 1c  of 7·0-11·0% (53-97 mmol/mol), who had been receiving stable doses of angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker therapy and glucose-lowering treatment for at least 12 weeks', 'enrolled patients at 116 research centres in Australia, Canada, Japan, South Korea, Mexico, South Africa, Spain, Taiwan, and the USA', 'patients with type 2 diabetes and moderate-to-severe chronic kidney disease', 'patients with type 2 diabetes', 'patients with type 2 diabetes and chronic kidney disease (DELIGHT']","['angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker treatment', 'placebo', 'interactive voice-web response system) to receive dapagliflozin (10 mg) only, dapagliflozin', 'dapagliflozin and saxagliptin', 'saxagliptin (2·5 mg), or placebo', 'dapagliflozin-saxagliptin', 'Dapagliflozin and dapagliflozin-saxagliptin', 'saxagliptin', 'Dapagliflozin with or without saxagliptin', 'sodium-glucose co-transporter-2 inhibitor dapagliflozin with and without the dipeptidyl peptidase-4 inhibitor saxagliptin', 'dapagliflozin']","['numbers of patients with adverse events', 'HbA 1c', 'mean UACR change', 'serious adverse events', 'change from baseline in UACR (dapagliflozin and dapagliflozin-saxagliptin groups) and HbA 1c']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4517736', 'cui_str': '3500'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C3811844'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C0014432', 'cui_str': 'Enzyme Inhibitors'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",1187.0,0.421698,HbA 1c  was reduced in the dapagliflozin-saxagliptin group (n=137) compared with the placebo group (n=118) at week 24 (-0·58% [-0·80 to -0·37; p<0·0001]).,"[{'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute, Royal North Shore Hospital, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Bergur', 'Initials': 'B', 'LastName': 'Stefánsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Reyner', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Centre Copenhagen Gentofte, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Centre for Nephrology, University College London, London, UK.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Clinical Pharmacy and Pharmacology Department, University Medical Centre Groningen, University of Groningen, Groningen, Netherlands. Electronic address: h.j.lambers.heerspink@umcg.nl.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30086-5']
1588,30910492,"Double-blind, placebo-controlled, randomized trial on low-dose azithromycin prophylaxis in patients with primary antibody deficiencies.","BACKGROUND


Lacking protective antibodies, patients with primary antibody deficiencies (PADs) experience frequent respiratory tract infections, leading to chronic pulmonary damage. Macrolide prophylaxis has proved effective in patients with chronic respiratory diseases.
OBJECTIVE


We aimed to test the efficacy and safety of orally administered low-dose azithromycin prophylaxis in patients with PADs.
METHODS


We designed a 3-year, double-blind, placebo-controlled, randomized clinical trial to test whether oral azithromycin (250 mg administered once daily 3 times a week for 2 years) would reduce respiratory exacerbations in patients with PADs and chronic infection-related pulmonary diseases. The primary end point was the number of annual respiratory exacerbations. Secondary end points included time to first exacerbation, additional antibiotic courses, number of hospitalizations, and safety.
RESULTS


Eighty-nine patients received azithromycin (n = 44) or placebo (n = 45). The number of exacerbations was 3.6 (95% CI, 2.5-4.7) per patient-year in the azithromycin arm and 5.2 (95% CI, 4.1-6.4) per patient-year in the placebo arm (P = .02). In the azithromycin group the hazard risk for having an acute exacerbation was 0.5 (95% CI, 0.3-0.9; P = .03), and the hazard risk for hospitalization was 0.5 (95% CI, 0.2-1.1; P = .04). The rate of additional antibiotic treatment per patient-year was 2.3 (95% CI, 2.1-3.4) in the intervention group and 3.6 (95% CI, 2.9-4.3) in the placebo group (P = .004). Haemophilus influenzae and Streptococcus pneumoniae were the prevalent isolates, and they were not susceptible to macrolides in 25% of patients of both arms. Azithromycin's safety profile was comparable with that of placebo.
CONCLUSION


The study reached the main outcome centered on the reduction of exacerbation episodes per patient-year, with a consequent reduction in additional courses of antibiotics and risk of hospitalization.",2019,"The number of exacerbations was 3.6 (95% CI, 2.5-4.7) per patient-year in the azithromycin arm and 5.2 (95% CI, 4.1-6.4) per patient-year in the placebo arm (P = .02).","['patients with chronic respiratory diseases', 'patients with primary antibody deficiencies', 'patients with PADs and chronic infection-related pulmonary diseases', 'patients with PADs', 'patients with primary antibody deficiencies (PADs) experience frequent respiratory tract infections']","['Macrolide prophylaxis', 'placebo', 'Azithromycin', 'azithromycin', 'azithromycin prophylaxis', 'oral azithromycin']","['number of annual respiratory exacerbations', 'respiratory exacerbations', 'hazard risk for having an acute exacerbation', 'hazard risk for hospitalization', 'time to first exacerbation, additional antibiotic courses, number of hospitalizations, and safety', 'efficacy and safety', 'rate of additional antibiotic treatment per patient-year', 'additional courses of antibiotics and risk of hospitalization', 'number of exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0151317', 'cui_str': 'Chronic infectious disease (disorder)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}]","[{'cui': 'C0003240', 'cui_str': 'Substance with macrolide structure and antibacterial mechanism of action (substance)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.652518,"The number of exacerbations was 3.6 (95% CI, 2.5-4.7) per patient-year in the azithromycin arm and 5.2 (95% CI, 4.1-6.4) per patient-year in the placebo arm (P = .02).","[{'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Milito', 'Affiliation': 'Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Pulvirenti', 'Affiliation': 'Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cinetto', 'Affiliation': 'Department of Medicine DIMED, University of Padova, Padova, Italy.'}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Lougaris', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, and ASST-Spedali Civili of Brescia, Brescia, Italy.'}, {'ForeName': 'Annarosa', 'Initials': 'A', 'LastName': 'Soresina', 'Affiliation': 'Department of Pediatrics, University of Brescia, ASST-Spedali Civili of Brescia, Brescia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pecoraro', 'Affiliation': 'Department of Translational Medical Sciences and Center for Basic and Clinical Immunology Research, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Vultaggio', 'Affiliation': 'Immunoallergology Unit, Department Medical-Geriatric, AOU Careggi, Florence, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Carrabba', 'Affiliation': ""Department of Internal Medicine, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lassandro', 'Affiliation': 'Department of Biomedicine and Evolutive Age, University of Bari, Bari, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Plebani', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, and ASST-Spedali Civili of Brescia, Brescia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Spadaro', 'Affiliation': 'Department of Translational Medical Sciences and Center for Basic and Clinical Immunology Research, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Matucci', 'Affiliation': 'Immunoallergology Unit, Department Medical-Geriatric, AOU Careggi, Florence, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Fabio', 'Affiliation': ""Department of Internal Medicine, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Rosa Maria', 'Initials': 'RM', 'LastName': 'Dellepiane', 'Affiliation': 'Department of Pediatrics, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.'}, {'ForeName': 'Baldassarre', 'Initials': 'B', 'LastName': 'Martire', 'Affiliation': 'Department of Biomedicine and Evolutive Age, University of Bari, Bari, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Agostini', 'Affiliation': 'Department of Medicine DIMED, University of Padova, Padova, Italy.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Abeni', 'Affiliation': 'Health Services Research Unit IDI, IRCCS, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tabolli', 'Affiliation': 'Health Services Research Unit IDI, IRCCS, Rome, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Quinti', 'Affiliation': 'Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy. Electronic address: isabella.quinti@uniroma1.it.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.01.051']
1589,31719084,Adapting the Diabetes Prevention Program for low and middle-income countries: protocol for a cluster randomised trial to evaluate 'Lifestyle Africa'.,"INTRODUCTION


Low and middle-income countries like South Africa are experiencing major increases in burden of non-communicable diseases such as diabetes and cardiovascular conditions. However, evidence-based interventions to address behavioural factors related to these diseases are lacking. Our study aims to adapt the CDC's National Diabetes Prevention Program (DPP) within the context of an under-resourced urban community in Cape Town, South Africa.
METHODS/ANALYSIS


The new intervention ( Lifestyle Africa ) consists of 17 weekly sessions delivered by trained community health workers (CHWs). In addition to educational and cultural adaptations of DPP content, the programme adds novel components of text messaging and CHW training in Motivational Interviewing. We will recruit overweight and obese participants (body mass index ≥25 kg/m 2 ) who are members of 28 existing community health clubs served by CHWs. In a 2-year cluster randomised control trial, clubs will be randomly allocated to receive the intervention or usual care. After year 1, usual care participants will also receive the intervention and both groups will be followed for another year. The primary outcome analysis will compare percentage of baseline weight loss at year 1. Secondary outcomes will include diabetes and cardiovascular risk indicators (blood pressure, haemoglobin A1C, lipids), changes in self-reported medication use, diet (fat and fruit and vegetable intake), physical activity and health-related quality of life. We will also assess potential psychosocial mediators/moderators as well as cost-effectiveness of the programme.
ETHICS/DISSEMINATION


Ethical approval was obtained from the University of Cape Town and Children's Mercy. Results will be submitted for publication in peer-reviewed journals and training curricula will be disseminated to local stakeholders.
TRIAL REGISTRATION NUMBER


NCT03342274.",2019,"In a 2-year cluster randomised control trial, clubs will be randomly allocated to receive the intervention or usual care.","['overweight and obese participants (body mass index ≥25\u2009kg/m 2 ) who are members of 28 existing community health clubs served by CHWs', 'under-resourced urban community in Cape Town, South Africa', ""University of Cape Town and Children's Mercy""]","['intervention or usual care', 'new intervention ( Lifestyle Africa ) consists of 17 weekly sessions delivered by trained community health workers (CHWs']","['diabetes and cardiovascular risk indicators (blood pressure, haemoglobin A1C, lipids), changes in self-reported medication use, diet (fat and fruit and vegetable intake), physical activity and health-related quality of life', 'percentage of baseline weight loss']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}]",28.0,0.119344,"In a 2-year cluster randomised control trial, clubs will be randomly allocated to receive the intervention or usual care.","[{'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles and Nutrition, Children's Mercy Hospitals and Clinics, Kansas City, Missouri, USA dcatley@cmh.edu.""}, {'ForeName': 'Thandi', 'Initials': 'T', 'LastName': 'Puoane', 'Affiliation': 'University of the Western Cape School of Public Health, Cape Town, South Africa.'}, {'ForeName': 'Lungiswa', 'Initials': 'L', 'LastName': 'Tsolekile', 'Affiliation': 'University of the Western Cape School of Public Health, Cape Town, South Africa.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Heatlh Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kandace', 'Initials': 'K', 'LastName': 'Fleming', 'Affiliation': 'Life Span Institute, University of Kansas, Lawrence, Kansas, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Hurley', 'Affiliation': 'Department of Pediatrics, University of Missouri Kansas City School of Medicine, Kansas City, Missouri, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'Department of Biobehavioral Health, Penn State College of Health and Human Development, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Mara Z', 'Initials': 'MZ', 'LastName': 'Vitolins', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Estelle V', 'Initials': 'EV', 'LastName': 'Lambert', 'Affiliation': 'Research Centre for Health through Physical Activity, Lifestyle and Sport (HPALS), Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Levitt', 'Affiliation': 'Department of Medicine and Chronic Disease Initiative for Africa, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': 'Department of Pediatrics, University of Missouri Kansas City School of Medicine, Kansas City, Missouri, USA.'}]",BMJ open,['10.1136/bmjopen-2019-031400']
1590,30987814,Chlorhexidine for meatal cleaning in reducing catheter-associated urinary tract infections: a multicentre stepped-wedge randomised controlled trial.,"BACKGROUND


Evidence for the benefits of antiseptic meatal cleaning in reducing catheter-associated urinary tract infection (UTI) is inconclusive. We assessed the efficacy of 0·1% chlorhexidine solution compared with normal saline for meatal cleaning before urinary catheter insertion in reducing the incidence of catheter-associated asymptomatic bacteriuria and UTI.
METHODS


A cross-sectional, stepped-wedge, open-label, randomised controlled trial was undertaken in Australian hospitals. Eligible hospitals were Australian public and private hospitals, with an intensive care unit and more than 30 000 hospital admissions per year. Hospitals were randomly assigned to an intervention crossover date using a computer-generated randomisation system. Crossover dates occurred every 8 weeks; during the first 8 weeks of the study, no hospitals were exposed to the intervention (control phase), after which each hospital sequentially crossed over from the control to the intervention every 8 weeks. Patients requiring a urinary cathetwer were potentially eligible for inclusion in this hospital-wide study. Participants were excluded if they were younger than 2 years, had a medical reason preventing the use of the chlorhexidine, had the catheter inserted in theatre, did not have the catheter insertion date documented, required in-and-out or suprapubic catheterisation, had symptoms and signs suggestive of UTI at the time of catheter insertion, or were currently undergoing treatment for UTI. The intervention was the use of 0·1% chlorhexidine solution for meatal cleaning before urinary catheterisation with 0·9% normal saline used in the control phase. Masking of hospitals was not possible because it was not feasible to mask staff administering the intervention. The co-primary outcomes were the number of cases of catheter-associated asymptomatic bacteriuria and UTI per 100 catheter-days and were assessed within 7 days of catheter insertion in the intention-to-treat population. This trial is registered with Australian New Zealand Clinical Trials Registry, number ACTRN12617000373370.
FINDINGS


21 hospitals were assessed for eligibility between Jan 5, 2017, and May 1, 2017; of these, three were successfully enrolled and randomised to one of three intervention crossover dates. 1642 participants in these hospitals were included in the study between Aug 1, 2017, and March 12, 2018, 697 (42%) in the control phase and 945 (58%) in the intervention period. In the control period, 13 catheter-associated UTI and 29 catheter-associated asymptomatic bacteriuria events in 2889 catheter-days (0·45 catheter-associated UTI cases and 1·00 catheter-associated asymptomatic bacteriuria cases per 100 catheter-days) were recorded compared with four catheter-associated UTI and 16 catheter-associated asymptomatic bacteriuria events in 2338 catheter-days (0·17 catheter-associated UTI cases and 0·68 catheter-associated asymptomatic bacteriuria cases per 100 catheter-days) during the intervention period. The intervention was associated with a 74% reduction in the incidence of catheter-associated asymptomatic bacteriuria (incident rate ratio 0·26, 95% CI 0·08-0·86, p=0·026), and a 94% decrease in the incidence of catheter-associated UTI (0·06, 95% CI 0·01-0·32, p=0·00080). There were no reported adverse events.
INTERPRETATION


The use of chlorhexidine solution for meatal cleaning before catheter insertion decreased the incidence of catheter-associated asymptomatic bacteriuria and UTI and has the potential to improve patient safety.
FUNDING


HCF Research Foundation.",2019,"The intervention was associated with a 74% reduction in the incidence of catheter-associated asymptomatic bacteriuria (incident rate ratio 0·26, 95% CI 0·08-0·86, p=0·026), and a 94% decrease in the incidence of catheter-associated UTI (0·06, 95% CI 0·01-0·32, p=0·00080).","['Participants were excluded if they were younger than 2 years, had a medical reason preventing the use of the chlorhexidine, had the catheter inserted in theatre, did not have the catheter insertion date documented, required in-and-out or suprapubic catheterisation, had symptoms and signs suggestive of UTI at the time of catheter insertion, or were currently undergoing treatment for UTI', 'Australian hospitals', '1642 participants in these hospitals were included in the study between Aug 1, 2017, and March 12, 2018, 697 (42%) in the control phase and 945 (58%) in the intervention period', '21 hospitals were assessed for eligibility between Jan 5, 2017, and May 1, 2017; of these, three were successfully enrolled', 'Patients requiring a urinary cathetwer were potentially eligible for inclusion in this hospital-wide study', 'Eligible hospitals were Australian public and private hospitals, with an intensive care unit and more than 30\u2008000 hospital admissions per year']","['Chlorhexidine', 'normal saline', 'chlorhexidine solution', 'antiseptic meatal cleaning', 'chlorhexidine solution for meatal cleaning before urinary catheterisation with 0·9% normal saline']","['incidence of catheter-associated asymptomatic bacteriuria', 'adverse events', 'catheter-associated urinary tract infections', 'number of cases of catheter-associated asymptomatic bacteriuria and UTI per 100 catheter-days', 'incidence of catheter-associated UTI', 'asymptomatic bacteriuria events']","[{'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0439508', 'cui_str': 'per year'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C3540796', 'cui_str': 'Antiseptic throat preparations'}, {'cui': 'C0042019', 'cui_str': 'Urinary Catheterization'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0262380', 'cui_str': 'Asymptomatic bacteriuria (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",21.0,0.152964,"The intervention was associated with a 74% reduction in the incidence of catheter-associated asymptomatic bacteriuria (incident rate ratio 0·26, 95% CI 0·08-0·86, p=0·026), and a 94% decrease in the incidence of catheter-associated UTI (0·06, 95% CI 0·01-0·32, p=0·00080).","[{'ForeName': 'Oyebola', 'Initials': 'O', 'LastName': 'Fasugba', 'Affiliation': ""Nursing Research Institute, Australian Catholic University & St Vincent's Health Australia, Sydney, NSW, Australia; Lifestyle Research Centre, Avondale College of Higher Education, Cooranbong, NSW, Australia.""}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Infectious Prevention and Healthcare Epidemiology Unit, Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gregory', 'Affiliation': 'Faculty of Arts, Nursing and Theology, Avondale College of Higher Education, Wahroonga, NSW, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Graves', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Koerner', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine Australian Catholic University, Watson, ACT, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Collignon', 'Affiliation': 'Australian Capital Territory Pathology, Canberra Hospital and Health Services, Yamba Drive, Garran, ACT, Australia; Medical School, Australian National University, Acton, ACT, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gardner', 'Affiliation': 'School of Public Health and Social Work, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Brett G', 'Initials': 'BG', 'LastName': 'Mitchell', 'Affiliation': 'Faculty of Arts, Nursing and Theology, Avondale College of Higher Education, Wahroonga, NSW, Australia; School of Nursing and Midwifery, University of Newcastle, Newcastle, NSW, Australia. Electronic address: brett.mitchell@avondale.edu.au.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30736-9']
1591,31000379,"Lidocaine and phenylephrine versus saline placebo nasal spray for the pain and distress of nasogastric tube insertion in young children and infants: a randomised, double-blind, controlled trial.","BACKGROUND


Nasogastric tube insertion is a common but distressing procedure in young children. We aimed to compare the efficacy of topical local anaesthetic and vasoconstrictor nasal spray with placebo for distress related to nasogastric tube insertion.
METHODS


We did a prospective, randomised, controlled, double-blind, superiority trial in a single tertiary paediatric emergency department in Australia. Eligible participants were children aged 6 months to 5 years who were planned to have a nasogastric tube inserted as part of their emergency department treatment. Patients were assigned using computer-generated block randomisation to receive lidocaine and phenylephrine nasal spray (10 mg lidocaine and 1 mg phenylephrine for children weighing 6-12 kg; 20 mg lidocaine and 2 mg phenylephrine for children weighing >12 kg), or 0·9% sodium chloride placebo nasal spray, before nasogastric insertion. Guardians, observers, and proceduralists were all masked to the intervention. The primary outcome was procedure-related distress, measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale during the final attempt at nasogastric tube insertion. All patients were included in the primary analysis (intention-to-treat). FLACC scores were compared using the Wilcoxon rank-sum test, and categorical outcomes were compared using χ 2  or Fisher's exact tests as appropriate. This study is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12614000092695.
FINDINGS


Between July 30, 2014, and Aug 17, 2017, 107 children in a convenience sample were randomly assigned to receive lidocaine and phenylephrine nasal spray (n=54) or placebo (n=53). Seven children did not receive study medication (six no longer required nasogastric tube insertion and one withdrew consent). 50 children received each intervention; all were included in the analysis. There was no difference in median FLACC score at time of nasogastric tube insertion (9 [IQR 7-10] for lidocaine and phenylephrine vs 9 [IQR 8-10] for placebo; median difference between groups -1, 95% CI -2·7 to 0·7, p=0·21). Adverse effects of the spray or nasogastric tube insertion (most commonly vomiting and gagging) occurred in 14 (28%) of those who received lidocaine and phenylephrine and 21 (42%) of those who received placebo.
INTERPRETATION


Lidocaine and phenylephrine nasal spray does not reduce procedure-related distress associated with nasogastric tube insertion in young children compared with placebo. Further research addressing distress associated with nasogastric tube insertion in young children is needed.
FUNDING


Monash Health Senior Medical Staff Association, Australasian College for Emergency Medicine, Emergency Medicine Research Foundation.",2019,"INTERPRETATION


Lidocaine and phenylephrine nasal spray does not reduce procedure-related distress associated with nasogastric tube insertion in young children compared with placebo.","['Eligible participants were children aged 6 months to 5 years who were planned to have a nasogastric tube inserted as part of their emergency department treatment', 'young children and infants', 'single tertiary paediatric emergency department in Australia', 'young children', '50 children received each intervention; all were included in the analysis', 'Between July 30, 2014, and Aug 17, 2017, 107 children in a convenience sample']","['lidocaine and 1 mg phenylephrine', 'placebo', 'phenylephrine', 'lidocaine', 'lidocaine and phenylephrine nasal spray', 'lidocaine and phenylephrine', 'Lidocaine and phenylephrine nasal spray', 'Nasogastric tube insertion', 'topical local anaesthetic and vasoconstrictor nasal spray with placebo', 'saline placebo nasal spray', 'lidocaine and 2 mg phenylephrine', 'Lidocaine and phenylephrine', '0·9% sodium chloride placebo nasal spray', 'nasogastric tube insertion']","['median FLACC score at time of nasogastric tube insertion', 'FLACC scores', 'procedure-related distress, measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale', 'vomiting and gagging', 'Adverse effects', 'pain and distress of nasogastric tube insertion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube, device (physical object)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1248657', 'cui_str': 'Phenylephrine Nasal Spray'}, {'cui': 'C0204819', 'cui_str': 'Intubation, Nasogastric'}, {'cui': 'C0472473', 'cui_str': 'Local anesthesia, surface'}, {'cui': 'C0042397', 'cui_str': 'Vasoactive Agonists'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0204819', 'cui_str': 'Intubation, Nasogastric'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",50.0,0.707132,"INTERPRETATION


Lidocaine and phenylephrine nasal spray does not reduce procedure-related distress associated with nasogastric tube insertion in young children compared with placebo.","[{'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Craig', 'Affiliation': ""Department of Medicine, School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia; Paediatric Emergency Department, Monash Medical Centre, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Parkville, VIC, Australia. Electronic address: simon.craig@monash.edu.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Seith', 'Affiliation': 'Department of Medicine, School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia; Paediatric Emergency Department, Monash Medical Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Cheek', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Emergency Department, Royal Children's Hospital, Parkville, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Egerton-Warburton', 'Affiliation': 'Department of Medicine, School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia; Paediatric Emergency Department, Monash Medical Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Eldho', 'Initials': 'E', 'LastName': 'Paul', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'West', 'Affiliation': 'Department of Medicine, School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia; Paediatric Emergency Department, Monash Medical Centre, Melbourne, VIC, Australia.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(19)30058-6']
1592,30981585,Disparate effects of first and second generation antipsychotics on cognition in schizophrenia - Findings from the randomized NeSSy trial.,"Cognitive impairment represents a core feature of schizophrenia. Uncertainty about demonstrable benefits of available antipsychotics on cognition remains an important clinical question relevant to patients' quality of life. The aim of our multi-center, randomized, double-blind ""Neuroleptic Strategy Study"" (NeSSy) was to compare the effectiveness of selected antipsychotics, conventionally classified as second- (SGAs) (haloperidol, flupentixol) and first generation antipsychotics (FGAs) (aripiprazole, olanzapine, quetiapine), on quality of life in schizophrenia. The effects on cognitive deficits represented a secondary outcome. We used an innovative double randomization for assignment of treatment group, and followed the patients with a neurocognitive test-battery upon six and 24 weeks of treatment. Psychopathology and quality of life were assessed using CGI, PANSS and SF-36. Assessment of cognitive performance was conducted in 114 of the 136 randomized patients. The SGA group (N = 62) showed beneficial effects of small to moderate effect size on cognition during the initial six weeks of treatment (executive functions, verbal fluency) and at 24 weeks (executive functions, working memory). In contrast, the FGA group (N = 52) showed moderately improved executive function, but a decline in verbal fluency at six weeks, with significant declines of moderate to large effect size in executive function, verbal learning and memory, and verbal fluency at 24 weeks. Our study indicates that SGAs present an advantage over FGAs regarding cognitive function during a medium-term treatment for schizophrenia. The results further emphasize a distinction between progression to detrimental effects of FGAs with prolonged treatment in contrast to more persistent cognitive benefits with SGA treatment.",2019,"Psychopathology and quality of life were assessed using CGI, PANSS and SF-36",['114 of the 136 randomized patients'],"['first and second generation antipsychotics', 'selected antipsychotics, conventionally classified as second- (SGAs', 'SGA', 'FGA', 'haloperidol, flupentixol) and first generation antipsychotics (FGAs) (aripiprazole, olanzapine, quetiapine']","['quality of life in schizophrenia', 'verbal fluency', 'Psychopathology and quality of life', 'cognitive deficits', 'executive function', 'executive function, verbal learning and memory, and verbal fluency', 'cognitive performance']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0016367', 'cui_str': 'flupentixol'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}]","[{'cui': 'C0034380'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",136.0,0.0767002,"Psychopathology and quality of life were assessed using CGI, PANSS and SF-36","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Veselinović', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, RWTH Aachen University, Pauwelsstrasse 30, 52074 Aachen, Germany. Electronic address: tveselinovic@ukaachen.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Scharpenberg', 'Affiliation': 'Competence Center for Clinical Trials - Biometry, University of Bremen, Bremen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heinze', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Brandenburg Medical School, Immanuel Klinik, Rüdersdorf, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Cordes', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Mühlbauer', 'Affiliation': 'Competence Center for Clinical Trials - Biometry, University of Bremen, Bremen, Germany; Department of Pharmacology, Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Juckel', 'Affiliation': 'Department of Psychiatry, LWL University Hospital, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Habel', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, RWTH Aachen University, Pauwelsstrasse 30, 52074 Aachen, Germany.'}, {'ForeName': 'Eckart', 'Initials': 'E', 'LastName': 'Rüther', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Timm', 'Affiliation': 'Competence Center for Clinical Trials - Biometry, University of Bremen, Bremen, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Gründer', 'Affiliation': 'Department of Molecular Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.03.014']
1593,31881928,Impact of human papillomavirus (HPV) self-collection on subsequent cervical cancer screening completion among under-screened US women: MyBodyMyTest-3 protocol for a randomized controlled trial.,"BACKGROUND


Screening substantially reduces cervical cancer incidence and mortality. More than half of invasive cervical cancers are attributable to infrequent screening or not screening at all. The current study, My Body My Test (MBMT), evaluates the impact of mailed kits for self-collection of samples for human papillomavirus (HPV) testing on completion of cervical cancer screening in low-income, North Carolina women overdue for cervical cancer screening.
METHODS/DESIGN


The study will enroll at least 510 US women aged 25-64 years who report no Pap test in the last 4 years and no HPV test in the last 6 years. We will randomize participants to an intervention or control arm. The intervention arm will receive kits to self-collect a sample at home and mail it for HPV testing. In both the intervention and control arms, participants will receive assistance in scheduling an appointment for screening in clinic. Study staff will deliver HPV self-collection results by phone and assist in scheduling participants for screening in clinic. The primary outcome is completion of cervical cancer screening. Specifically, completion of screening will be defined as screening in clinic or receipt of negative HPV self-collection results. Women with HPV-negative self-collection results will be considered screening-complete. All other participants will be considered screening-complete if they obtain co-testing or Pap test screening at a study-affiliated institution or other clinic. We will assess whether the self-collection intervention influences participants' perceived risk of cervical cancer and whether perceived risk mediates the relationship between HPV self-collection results and subsequent screening in clinic. We also will estimate the incremental cost per woman screened of offering at-home HPV self-collection kits with scheduling assistance as compared to offering scheduling assistance alone.
DISCUSSION


If mailed self-collection of samples for HPV testing is an effective strategy for increasing cervical cancer screening among women overdue for screening, this method has the potential to reduce cervical cancer incidence and mortality in medically underserved women at higher risk of developing cervical cancer.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02651883, Registered on 11 January 2016.",2019,"The current study, My Body My Test (MBMT), evaluates the impact of mailed kits for self-collection of samples for human papillomavirus (HPV) testing on completion of cervical cancer screening in low-income, North Carolina women overdue for cervical cancer screening.
","['510 US women aged 25-64 years who report no Pap test in the last 4 years and no HPV test in the last 6 years', 'subsequent cervical cancer screening completion among under-screened US women', 'participants for screening in clinic', 'medically underserved women at higher risk of developing cervical cancer', 'human papillomavirus (HPV) testing on completion of cervical cancer screening in low-income, North Carolina women overdue for cervical cancer screening']","['human papillomavirus (HPV) self-collection', 'self-collection intervention']","['cervical cancer incidence and mortality', 'completion of cervical cancer screening']","[{'cui': 'C4517800', 'cui_str': '510 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3541459', 'cui_str': 'Papanicolaou Smear'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",,0.072489,"The current study, My Body My Test (MBMT), evaluates the impact of mailed kits for self-collection of samples for human papillomavirus (HPV) testing on completion of cervical cancer screening in low-income, North Carolina women overdue for cervical cancer screening.
","[{'ForeName': 'Lisa P', 'Initials': 'LP', 'LastName': 'Spees', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, 1102-G McGavran-Greenberg, CB7411, Chapel Hill, NC, 27599-7411, USA. lspees21@email.unc.edu.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Des Marais', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, 2103 McGavran-Greenberg, CB7435, Chapel Hill, NC, 27599-7435, USA.'}, {'ForeName': 'Stephanie B', 'Initials': 'SB', 'LastName': 'Wheeler', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, 1102-G McGavran-Greenberg, CB7411, Chapel Hill, NC, 27599-7411, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Hudgens', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Doughty', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, 2103 McGavran-Greenberg, CB7435, Chapel Hill, NC, 27599-7435, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Smith', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA. jennifers@unc.edu.'}]",Trials,['10.1186/s13063-019-3959-2']
1594,30968235,The Effect of Music on the Comfort and Anxiety of Older Adults Living in a Nursing Home in Turkey.,"The study was designed as a randomized controlled experimental study with a pretest/posttest and a control group. The study sample comprised 56 seniors who resided in a nursing home. The study data were collected using the ""Mini-Mental State Examination,"" ""Identification Form,"" ""General Comfort Questionnaire,"" and ""Beck Anxiety Inventory."" While the mean scores obtained from the General Comfort Questionnaire by the participants in the experimental group demonstrated significant differences (p < 0.05), those obtained by the participants in the control group did not (p > 0.05). The mean scores obtained from the Beck Anxiety Inventory by the participants in the experimental group after a 3-week music intervention were significantly higher than their pre-study scores (p < 0.05); however, no significant increase was observed in the control group (p < 0.05).It was determined that music reduced anxiety experienced by the older adults since it improved their comfort.",2019,"The mean scores obtained from the Beck Anxiety Inventory by the participants in the experimental group after a 3-week music intervention were significantly higher than their pre-study scores (p < 0.05); however, no significant increase was observed in the control group (p < 0.05).It was determined that music reduced anxiety experienced by the older adults since it improved their comfort.","['Older Adults Living in a Nursing Home in Turkey', '56 seniors who resided in a nursing home']",['Music'],"['Beck Anxiety Inventory', 'Mini-Mental State Examination,"" ""Identification Form,"" ""General Comfort Questionnaire,"" and ""Beck Anxiety Inventory', 'Comfort and Anxiety', 'General Comfort Questionnaire']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home (finding)'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0192397,"The mean scores obtained from the Beck Anxiety Inventory by the participants in the experimental group after a 3-week music intervention were significantly higher than their pre-study scores (p < 0.05); however, no significant increase was observed in the control group (p < 0.05).It was determined that music reduced anxiety experienced by the older adults since it improved their comfort.","[{'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Ergin', 'Affiliation': 'Department of Fundamentals Nursing, Faculty of Health Sciences, Manisa Celal Bayar University, 45000, Manisa, Turkey. edayasar35@hotmail.com.'}, {'ForeName': 'Şebnem', 'Initials': 'Ş', 'LastName': 'Çinar Yücel', 'Affiliation': 'Department of Fundamentals Nursing, Faculty of Nursing, Ege University, 35000, Izmir, Turkey.'}]",Journal of religion and health,['10.1007/s10943-019-00811-z']
1595,31718959,Surface treatments of a glass-fiber reinforced composite: Effect on the adhesion to a composite resin.,"PURPOSE


To compare the effect of different surface treatments (pre-treatments and bonding agents) on the bond strength between glass-fiber post and composite resin, and the topographic alterations of the treated post surface.
METHODS


Thirty-six glass-fiber blocks (12mm×10mm×8mm) were specifically manufactured for this study and randomly assigned into 12 groups considering two factors: 'pre-treatments' (-cleaning with 70% alcohol; air-abrasion with silica-coated aluminum oxide particles; 35% hydrogen peroxide) and type of 'bonding agent' (no bonding agent; application of Monobond Plus; RelyX Ceramic Primer; Single Bond Universal). After that, 6 cylindrical templates (1mm high×1mm Ø) were fixed on each block, filled with composite resin (n=18) and light-cured. Specimens were stored under 37°C for 24h and microshear tests (wire loop Ø=0.2mm) were performed. Topographic, roughness and failure analyses were also performed.
RESULTS


Different surface pre-treatments led to different topographic and roughness alterations; a higher surface alteration was noted after silica particles air-abrasion, while a slight surface alteration in the hydrogen peroxide group and a smooth pattern were observed in the cleaning group. The factors 'pre-treatments' (p<0.05), 'bonding agent' (p<0.05) and their interaction (p<0.05) influenced the bond strength. Silica coating, apart from bonding agent application, or Single Bond Universal application without pre-treatment promoted the highest bond values. The main failure type was adhesive at the resin-post interface.
CONCLUSIONS


In terms of pre-treatments, silica coating promotes the best bonding performance, but pre-treatments can be dispensable when applying Single Bond Universal.",2020,"Silica coating, apart from bonding agent application, or Single Bond Universal application without pre-treatment promoted the highest bond values.",[],"[""pre-treatments' (-cleaning with 70% alcohol; air-abrasion with silica-coated aluminum oxide particles; 35% hydrogen peroxide) and type of 'bonding agent' (no bonding agent; application of Monobond Plus; RelyX Ceramic Primer; Single Bond Universal""]","['Topographic, roughness and failure analyses']",[],"[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1302752', 'cui_str': 'Abrasion (morphologic abnormality)'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0887544', 'cui_str': 'Aluminum Oxide (AlO2)'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0759863', 'cui_str': 'single bond'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",,0.0527095,"Silica coating, apart from bonding agent application, or Single Bond Universal application without pre-treatment promoted the highest bond values.","[{'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Cadore-Rodrigues', 'Affiliation': 'Post-Graduate Program in Oral Science, Division of Prosthetic Dentistry, Federal University of Santa Maria, Marechal Floriano Peixoto Street 1184, 97015-372 Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: anacadorerodrigues@gmail.com.'}, {'ForeName': 'Luís F', 'Initials': 'LF', 'LastName': 'Guilardi', 'Affiliation': 'Post-Graduate Program in Oral Science, Division of Prosthetic Dentistry, Federal University of Santa Maria, Marechal Floriano Peixoto Street 1184, 97015-372 Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: luisfguilardi@hotmail.com.'}, {'ForeName': 'Vinicius F', 'Initials': 'VF', 'LastName': 'Wandscher', 'Affiliation': 'Faculty of Odontology, Prosthodontics Unit, Franciscan University, Silva Jardim Street 1175, 97010-491 Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: viniwan@hotmail.com.'}, {'ForeName': 'Gabriel K R', 'Initials': 'GKR', 'LastName': 'Pereira', 'Affiliation': 'Post-Graduate Program in Dentistry, School of Dentistry, Meridional Faculty - IMED, Senador Pinheiro Street 304, 99070-220 Passo Fundo, Rio Grande do Sul State, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Luiz F', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Post-Graduate Program in Oral Science, Division of Prosthetic Dentistry, Federal University of Santa Maria, Marechal Floriano Peixoto Street 1184, 97015-372 Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}, {'ForeName': 'Marília P', 'Initials': 'MP', 'LastName': 'Rippe', 'Affiliation': 'Post-Graduate Program in Oral Science, Division of Prosthetic Dentistry, Federal University of Santa Maria, Marechal Floriano Peixoto Street 1184, 97015-372 Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: mariliarippe@mail.ufsm.br.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2019.09.001']
1596,30989175,From 'OPAT' to 'COpAT': implications of the OVIVA study for ambulatory management of bone and joint infection.,"Bone and joint infection contributes significantly to clinical activity within outpatient parenteral antimicrobial therapy (OPAT) services. The OVIVA (oral versus intravenous antibiotics for bone and joint infection) randomized study has challenged the practice of prolonged intravenous therapy, because non-inferiority of oral antibiotic therapy was demonstrated, thereby implying that early transition to oral therapy is an appropriate alternative to prolonged intravenous therapy. We examine the caveats to the study and discuss the implications for OPAT practice, highlighting the importance of careful oral antibiotic selection with attention to bioavailability, bone penetration, drug interactions, compliance and toxicity monitoring. We emphasize that ambulatory antibiotic therapy (whether intravenous or oral) in this patient group requires expert multidisciplinary management, monitoring and follow-up, and ideally should be undertaken within existing OPAT or, more accurately, complex outpatient antibiotic therapy (COpAT) services.",2019,"The OVIVA (oral versus intravenous antibiotics for bone and joint infection) randomized study has challenged the practice of prolonged intravenous therapy, because non-inferiority of oral antibiotic therapy was demonstrated, thereby implying that early transition to oral therapy is an appropriate alternative to prolonged intravenous therapy.",[],"['OVIVA (oral versus intravenous antibiotics', 'ambulatory antibiotic therapy']",[],[],"[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}]",[],,0.0171451,"The OVIVA (oral versus intravenous antibiotics for bone and joint infection) randomized study has challenged the practice of prolonged intravenous therapy, because non-inferiority of oral antibiotic therapy was demonstrated, thereby implying that early transition to oral therapy is an appropriate alternative to prolonged intravenous therapy.","[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Seaton', 'Affiliation': 'Department of Infectious Diseases, Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow G51 4TF, UK.'}, {'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'Ritchie', 'Affiliation': 'Department of Infectious Diseases, Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow G51 4TF, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Robb', 'Affiliation': 'Department of Pharmacy, Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow G51 4TF, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Stewart', 'Affiliation': 'Department of Pharmacy, Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow G51 4TF, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'White', 'Affiliation': 'Department of Infectious Diseases, Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow G51 4TF, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vallance', 'Affiliation': 'Outpatient Parenteral Antimicrobial Therapy Service, Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow G51 4TF, UK.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz122']
1597,30975525,"Immunogenicity and reactogenicity of ten-valent versus 13-valent pneumococcal conjugate vaccines among infants in Ho Chi Minh City, Vietnam: a randomised controlled trial.","BACKGROUND


Few data are available to support the choice between the two currently available pneumococcal conjugate vaccines (PCVs), ten-valent PCV (PCV10) and 13-valent PCV (PCV13). Here we report a head-to-head comparison of the immunogenicity and reactogenicity of PCV10 and PCV13.
METHODS


In this parallel, open-label, randomised controlled trial, healthy infants from two districts in Ho Chi Minh City, Vietnam, were randomly allocated (in a 3:3:5:4:5:4 ratio), with use of a computer-generated list, to one of six infant PCV schedules: PCV10 in a 3 + 1 (group A), 3 + 0 (group B), 2 + 1 (group C), or two-dose schedule (group D); PCV13 in a 2 + 1 schedule (group E); or no infant PCV (control; group F). Blood samples were collected from infants between 2 months and 18 months of age at various timepoints before and after PCV doses and analysed (in a blinded manner) by ELISA and opsonophagocytic assay. The trial had two independent aims: to compare vaccination responses between PCV10 and PCV13, and to evaluate different schedules of PCV10. In this Article, we present results pertaining to the first aim. The primary outcome was the proportion of infants with an IgG concentration of at least 0·35 μg/mL for the ten serotypes common to the two vaccines at age 5 months, 4 weeks after the two-dose primary vaccination series (group C vs group E, per protocol population). An overall difference among the schedules was defined as at least seven of ten serotypes differing in the same direction at the 10% level. We also assessed whether the two-dose primary series of PCV13 (group E) was non-inferior at the 10% level to a three-dose primary series of PCV10 (groups A and B). This trial is registered with ClinicalTrials.gov, number NCT01953510.
FINDINGS


Of 1424 infants screened between Sept 30, 2013, and Jan 9, 2015, 1201 were allocated to the six groups: 152 (13%) to group A, 149 (12%) to group B, 250 (21%) to group C, 202 (17%) to group D, 251 (21%) to group E, and 197 (16%) to group F. 237 (95%) participants in group C (PCV10) and 232 (92%) in group E (PCV13) completed the primary vaccination series and had blood draws within the specified window at age 5 months, at which time the proportion of infants with IgG concentrations of at least 0·35 μg/mL did not differ between groups at the 10% level for any serotype (PCV10-PCV13 risk difference -2·1% [95% CI -4·8 to -0·1] for serotype 1; -1·3% [-3·7 to 0·6] for serotype 4; -3·4% [-6·8 to -0·4] for serotype 5; 15·6 [7·2 to 23·7] for serotype 6B; -1·3% [-3·7 to 0·6] for serotype 7F; -1·6% [-5·1 to 1·7] for serotype 9V; 0·0% [-2·7 to 2·9] for serotype 14; -2·1% [-5·3 to 0·9] for serotype 18C; 0·0% [-2·2 to 2·3] for serotype 19F; and -11·6% [-18·2 to -4·9] for serotype 23F). At the same timepoint, two doses of PCV13 were non-inferior to three doses of PCV10 for nine of the ten shared serotypes (excluding 6B). Reactogenicity and serious adverse events were monitored according to good clinical practice guidelines, and the profiles were similar in the two groups.
INTERPRETATION


PCV10 and PCV13 are similarly highly immunogenic when used in 2 + 1 schedule. The choice of vaccine might be influenced by factors such as the comparative magnitude of the antibody responses, price, and the relative importance of different serotypes in different settings.
FUNDING


National Health and Medical Research Council of Australia, and Bill & Melinda Gates Foundation.",2019,"At the same timepoint, two doses of PCV13 were non-inferior to three doses of PCV10 for nine of the ten shared serotypes (excluding 6B).","['infants in Ho Chi Minh City, Vietnam', 'healthy infants from two districts in Ho Chi Minh City, Vietnam', 'Of 1424 infants screened between Sept 30, 2013, and Jan 9, 2015, 1201']","['valent versus 13-valent pneumococcal conjugate vaccines', 'PCV13', 'PCV10', 'PCV10 and PCV13']","['Immunogenicity and reactogenicity', 'Blood samples', 'proportion of infants with an IgG concentration', 'Reactogenicity and serious adverse events']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1720589', 'cui_str': 'Greek letter chi'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}, {'cui': 'C3849486', 'cui_str': 'ten-valent PCV'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0963062,"At the same timepoint, two doses of PCV13 were non-inferior to three doses of PCV10 for nine of the ten shared serotypes (excluding 6B).","[{'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Temple', 'Affiliation': ""Division of Global and Tropical Health, Menzies School of Health Research, Darwin, NT, Australia; Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK; Department of Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia. Electronic address: beth.temple@menzies.edu.au.""}, {'ForeName': 'Nguyen Trong', 'Initials': 'NT', 'LastName': 'Toan', 'Affiliation': 'Department of Disease Control and Prevention, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vo Thi Trang', 'Initials': 'VTT', 'LastName': 'Dai', 'Affiliation': 'Department of Microbiology and Immunology, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Bright', 'Affiliation': ""Department of Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Paul Vincent', 'Initials': 'PV', 'LastName': 'Licciardi', 'Affiliation': ""Department of Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Rachel Ann', 'Initials': 'RA', 'LastName': 'Marimla', 'Affiliation': ""Department of Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Cattram Duong', 'Initials': 'CD', 'LastName': 'Nguyen', 'Affiliation': ""Department of Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Doan Y', 'Initials': 'DY', 'LastName': 'Uyen', 'Affiliation': 'Department of Disease Control and Prevention, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Balloch', 'Affiliation': ""Department of Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Tran Ngoc', 'Initials': 'TN', 'LastName': 'Huu', 'Affiliation': 'Department of Disease Control and Prevention, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Edward Kim', 'Initials': 'EK', 'LastName': 'Mulholland', 'Affiliation': ""Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK; Department of Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia.""}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30734-5']
1598,30968810,Predictors and moderators of burden of care and emotional distress in first-episode psychosis caregivers: results from the GET UP pragmatic cluster randomised controlled trial.,"AIMS


First-episode psychosis (FEP) is a major life event and can have an adverse impact on the diagnosed individual and their families. The importance of intervening early and providing optimal treatments is widely acknowledged. In comparison to patient groups, literature is scarce on identifying treatment predictors and moderators of caregiver outcomes. This study aimed to identify pre-treatment characteristics predicting and/or moderating carer outcomes, based on data from a multi-element psychosocial intervention to FEP patients and carers (GET-UP PIANO trial).
METHODS


Carer demography, type of family relationship, patient contact hours, pre-treatment carer burden, patient perceptions of parental caregiving and expressed emotion (EE) were selected, a priori, as potential predictors/moderators of carer burden and emotional distress at 9 months post treatment. Outcomes were analysed separately in mixed-effects random regression models.
RESULTS


Analyses were performed on 260 carers. Only patient perceptions of early maternal criticism predicted reports of lower carer burden at follow-up. However, multiple imputation analysis failed to confirm this result. For treatment moderators: higher levels of carer burden at baseline yielded greater reductions in carer emotional distress at follow-up in the experimental group compared with treatment as usual (TAU). Higher levels of perceived EE moderated greater reductions in carer reports of tension in experimental group, compared with TAU, at follow-up. In younger caregivers (<51 years old), there were greater reductions in levels of worry during the baseline to follow-up period, within the experimental group compared with TAU.
CONCLUSION


The study failed to identify significant treatment predictors of FEP carer outcomes. However, our preliminary findings suggest that optimal treatment outcomes for carers at first episode might be moderated by younger carer age, and carers reporting higher baseline levels of burden, and where patients perceive higher levels of negative effect from caregivers.",2019,"Higher levels of perceived EE moderated greater reductions in carer reports of tension in experimental group, compared with TAU, at follow-up.","['260 carers', 'first-episode psychosis caregivers', 'Carer demography, type of family relationship, patient contact hours, pre-treatment carer burden, patient perceptions of parental caregiving and expressed emotion (EE']",[],"['carer emotional distress', 'levels of worry', 'burden of care and emotional distress']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0302826', 'cui_str': 'Expressed Emotion'}]",[],"[{'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}]",260.0,0.111307,"Higher levels of perceived EE moderated greater reductions in carer reports of tension in experimental group, compared with TAU, at follow-up.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Onwumere', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, England.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bonetto', 'Affiliation': 'Section of Psychiatry, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lasalvia', 'Affiliation': 'Unit of Psychiatry, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Miglietta', 'Affiliation': 'Section of Psychiatry, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Veronese', 'Affiliation': 'Department of Neurosciences, University of Padova and Azienda Ospedaliera, Padua, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bellini', 'Affiliation': 'Department of Mental Health, Azienda USL Romagna, CMHC Riccione, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Imbesi', 'Affiliation': 'Department of Mental Health, Azienda USL, Piacenza, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bebbington', 'Affiliation': 'Department of Psychiatry, University College London, London, England.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kuipers', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, England.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ruggeri', 'Affiliation': 'Section of Psychiatry, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Epidemiology and psychiatric sciences,['10.1017/S2045796019000155']
1599,31669446,Preventing child mental health problems through parenting interventions in Southeastern Europe (RISE): Protocol for a multi-country cluster randomized factorial study.,"BACKGROUND


Child mental health problems continue to be a major global concern, especially in low- and middle-income countries (LMICs). Parenting interventions have been shown to be effective for reducing child behavior problems in high-income countries, with emerging evidence supporting similar effects in LMICs. However, there remain substantial barriers to scaling up evidence-based interventions due to limited human and financial resources in such countries.
METHODS


This protocol is for a multi-center cluster randomized factorial trial of an evidence-based parenting intervention, Parenting for Lifelong Health for Young Children, for families with children ages 2-9 years with subclinical levels of behavior problems in three Southeastern European countries, Republic of Moldova, North Macedonia, and Romania (8 conditions, 48 clusters, 864 families, 108 per condition). The trial will test three intervention components: length (5 vs. 10 sessions), engagement (basic vs. enhanced package), and fidelity (on-demand vs. structured supervision). Primary outcomes are child aggressive behavior, dysfunctional parenting, and positive parenting. Analyses will examine the main effect and cost-effectiveness of each component, as well as potential interaction effects between components, in order to identify the most optimal combination of program components.
DISCUSSION


This study is the first factorial experiment of a parenting program in LMICs. Findings will inform the subsequent testing of the optimized program in a multisite randomized controlled trial in 2021.
TRIAL REGISTRATION


NCT03865485 registered in ClinicalTrials.gov on March 5, 2019.",2019,"Parenting interventions have been shown to be effective for reducing child behavior problems in high-income countries, with emerging evidence supporting similar effects in LMICs.","['Young Children, for families with children ages 2-9\u202fyears with subclinical levels of behavior problems in three Southeastern European countries, Republic of Moldova, North Macedonia, and Romania (8 conditions, 48 clusters, 864 families, 108 per condition', 'Southeastern Europe (RISE']","['evidence-based parenting intervention, Parenting for Lifelong Health', 'parenting interventions']","['child aggressive behavior, dysfunctional parenting, and positive parenting']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0026374', 'cui_str': 'Moldavian S.S.R.'}, {'cui': 'C0206004', 'cui_str': 'Macedonia, Former Yugoslave Republic of'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",864.0,0.254556,"Parenting interventions have been shown to be effective for reducing child behavior problems in high-income countries, with emerging evidence supporting similar effects in LMICs.","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Lachman', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy and Intervention, University of Oxford, Oxford, UK; MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK. Electronic address: jamie.lachman@spi.ox.ac.uk.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, University of Bremen, Bremen, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Jansen', 'Affiliation': 'Institute for Psychology, Alpen-Adria-University Klagenfurt, Klagenfurt, Austria.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Brühl', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, University of Bremen, Bremen, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Taut', 'Affiliation': 'Department of Psychology, Babeș-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Xiangming', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, GA, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy and Intervention, University of Oxford, Oxford, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Hutchings', 'Affiliation': 'Centre for Evidence Based Early Intervention, School of Psychology, Bangor University, Bangor, UK.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Ward', 'Affiliation': 'Department of Psychology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Margiad Elen', 'Initials': 'ME', 'LastName': 'Williams', 'Affiliation': 'Centre for Evidence Based Early Intervention, School of Psychology, Bangor University, Bangor, UK.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Raleva', 'Affiliation': 'Institute for Marriage, Family and Systemic Practice - ALTERNATIVA, Skopje, North Macedonia.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Båban', 'Affiliation': 'Department of Psychology, Babeș-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Lesco', 'Affiliation': 'Health for Youth Association, Chișinău, Republic of Moldova.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Foran', 'Affiliation': 'Institute for Psychology, Alpen-Adria-University Klagenfurt, Klagenfurt, Austria.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105855']
1600,30968336,Efficacy of Triamcinolone Acetonide Extended-Release in Participants with Unilateral Knee Osteoarthritis: A Post Hoc Analysis.,"INTRODUCTION


Osteoarthritis (OA) is common and its prevalence is increased in military service members. In a phase 3 randomized controlled trial (NCT02357459), a single intra-articular injection of an extended-release formulation of triamcinolone acetonide (TA-ER) in participants with unilateral or bilateral knee OA demonstrated substantial improvement in pain and symptoms. Bilateral knee pain has emerged as a confounding factor in clinical trials when evaluating the effect of a single intra-articular injection. Furthermore, unilateral disease is frequently first to emerge in active military personnel secondary to prior traumatic joint injury. In this post hoc analysis, we assessed efficacy and safety of TA-ER in a subgroup of participants with unilateral knee OA.
METHODS


Participants ≥ 40 years of age with symptomatic knee OA were randomized to a single intra-articular injection of TA-ER 32 mg, TA crystalline suspension (TAcs) 40 mg, or saline-placebo. Average daily pain (ADP)-intensity and rescue medication use were collected at each of weeks 1-24 postinjection; Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-A (pain), WOMAC-B (stiffness), WOMAC-C (function), and Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QoL) were collected at weeks 4, 8, 12, 16, 20, and 24 postinjection. Adverse events (AEs) were assessed throughout the study. Participants with unilateral knee OA were selected for this analysis.
RESULTS


Of 170 participants with unilateral OA (TA-ER, N = 51; saline-placebo, N = 60; TAcs, N = 59), 42% were male and 89% were white. TA-ER significantly (p < 0.05) improved ADP-intensity vs. saline-placebo (weeks 1-24) and TAcs (weeks 4-21). TA-ER significantly (p < 0.05) improved WOMAC-A vs. saline-placebo (all time points) and TAcs (weeks 4, 8, 12, 24). Consistent outcomes were observed for rescue medication, WOMAC-B, WOMAC-C, and KOOS-QoL. AEs were similar in frequency/type across treatments.
CONCLUSION


TA-ER provided 5-6 months' pain relief that consistently exceeded saline-placebo and TAcs, suggesting that TA-ER injected intra-articularly into the affected knee may be an effective non-opioid treatment option. Although the participants included in this analysis did not fully represent the diverse demographics of active service members, the substantial unmet medical need in the military population suggests that TA-ER may be an important treatment option; additional studies of TA-ER in active military patients are needed.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02357459.
FUNDING


Flexion Therapeutics, Inc. Plain language summary available for this article.",2019,"Consistent outcomes were observed for rescue medication, WOMAC-B, WOMAC-C, and KOOS-QoL. AEs were similar in frequency/type across treatments.
","[' N\u2009=\u200960; TAcs, N\u2009=\u200959), 42% were male and 89% were white', 'participants with unilateral knee OA', '40\xa0years of age with symptomatic knee OA', 'Participants ≥', 'Participants with Unilateral Knee Osteoarthritis', 'participants with unilateral or bilateral knee OA', 'Participants with unilateral knee OA', '170 participants with unilateral OA (TA-ER, N\u2009=\u200951']","['triamcinolone acetonide (TA-ER', 'Triamcinolone Acetonide', 'saline-placebo', 'TA crystalline suspension (TAcs) 40\xa0mg, or saline-placebo', ' saline-placebo', 'single intra-articular injection of TA-ER']","['TA-ER', 'rescue medication, WOMAC-B, WOMAC-C, and KOOS-QoL. AEs', 'pain and symptoms', 'Average daily pain (ADP)-intensity and rescue medication use', 'ADP-intensity', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-A (pain), WOMAC-B (stiffness), WOMAC-C (function), and Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QoL', 'Adverse events (AEs', 'efficacy and safety of TA-ER', 'pain relief']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021488', 'cui_str': 'Intra-Articular Injections'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",170.0,0.622245,"Consistent outcomes were observed for rescue medication, WOMAC-B, WOMAC-C, and KOOS-QoL. AEs were similar in frequency/type across treatments.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Langworthy', 'Affiliation': 'Department of Orthopedics and Orthopedic Surgery, Southcoast Health Systems, 300 A Faunce Corner Road, Dartmouth, MA, 02747, USA. lcdrlang@aol.com.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Ruane', 'Affiliation': 'McConnell Spine, Sport and Joint Physicians, 3773 Olentangy River Rd, Columbus, OH, 43214, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, 175 Meadowbrook Lane, PO Box 1018, Duncansville, PA, 16635, USA.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Lufkin', 'Affiliation': 'Independent Consultant, Beverly, MA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cinar', 'Affiliation': 'Flexion Therapeutics, Inc, 10 Mall Road, Suite 301, Burlington, MA, 01803, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Kelley', 'Affiliation': 'Flexion Therapeutics, Inc, 10 Mall Road, Suite 301, Burlington, MA, 01803, USA.'}]",Advances in therapy,['10.1007/s12325-019-00944-3']
1601,30926298,Durability of the neutralizing antibody response to vaccine and non-vaccine HPV types 7 years following immunization with either Cervarix® or Gardasil® vaccine.,"Bivalent (Cervarix®) and quadrivalent (Gardasil®) Human Papillomavirus (HPV) vaccines demonstrate remarkable efficacy against the targeted genotypes, HPV16 and HPV18, but also a degree of cross-protection against non-vaccine incorporated genotypes, HPV31 and HPV45. These outcomes seem to be supported by observations that the HPV vaccines induce high titer neutralizing antibodies against vaccine types and lower responses against non-vaccine types. Few data are available on the robustness of the immune response against non-vaccine types. We examined the durability of vaccine and non-vaccine antibody responses in a follow up of a head-to-head study of 12-15 year old girls initially randomized to receive three doses of Cervarix® or Gardasil® vaccine. Neutralizing antibodies against both vaccine and non-vaccine types remained detectable up to 7 years following initial vaccination and a mixed effects model was used to predict the decline in antibody titers over a 15 year period. The decline in vaccine and non-vaccine type neutralizing antibody titers over the study period was estimated to be 30% every 5-7 years, with Cervarix® antibody titers expected to remain 3-4 fold higher than Gardasil® antibody titers over the long term. The antibody decline rates in those with an initial response to non-vaccine types were similar to that of vaccine types and are predicted to remain detectable for many years. Empirical data on the breadth, magnitude, specificity and durability of the immune response elicited by the HPV vaccines contribute to improving the evidence base supporting this important public health intervention. Original trial: ClinicalTrials.gov NCT00956553.",2019,Neutralizing antibodies against both vaccine and non-vaccine types remained detectable up to 7 years following initial vaccination and a mixed effects model was used to predict the decline in antibody titers over a 15 year period.,['a follow up of a head-to-head study of 12-15\u202fyear old girls'],"['vaccine and non-vaccine HPV', 'Cervarix® or Gardasil® vaccine', 'vaccine and non-vaccine antibody responses', 'Bivalent (Cervarix®) and quadrivalent (Gardasil®) Human Papillomavirus (HPV) vaccines']","['antibody titers', 'antibody decline rates']","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1721789', 'cui_str': 'Cervarix'}, {'cui': 'C1721787', 'cui_str': 'Gardasil'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",,0.0318268,Neutralizing antibodies against both vaccine and non-vaccine types remained detectable up to 7 years following initial vaccination and a mixed effects model was used to predict the decline in antibody titers over a 15 year period.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Godi', 'Affiliation': 'Virus Reference Department, Public Health England, London, UK.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Panwar', 'Affiliation': 'Virus Reference Department, Public Health England, London, UK.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Haque', 'Affiliation': 'Virus Reference Department, Public Health England, London, UK.'}, {'ForeName': 'Clementina E', 'Initials': 'CE', 'LastName': 'Cocuzza', 'Affiliation': 'Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Andrews', 'Affiliation': 'Statistics, Modelling and Economics Department, Public Health England, London, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Southern', 'Affiliation': 'Immunisation and Countermeasures Public Health England, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Turner', 'Affiliation': 'Section of Paediatrics, Imperial College London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': 'Immunisation and Countermeasures Public Health England, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Beddows', 'Affiliation': 'Virus Reference Department, Public Health England, London, UK. Electronic address: simon.beddows@phe.gov.uk.'}]",Vaccine,['10.1016/j.vaccine.2019.03.052']
1602,30949704,Pharmacokinetics and tolerability of lefamulin following intravenous and oral dosing.,"OBJECTIVES


To explore the pharmacokinetics (PK) of oral and intravenous (iv) lefamulin after single and multiple doses, and the effect of food on bioavailability.
METHODS


Lefamulin PK was examined in four studies. In Study 1, PK was assessed in patients with acute bacterial skin and skin structure infections who received repeated iv lefamulin q12h (150 mg). In Study 2, a four-period crossover study, healthy subjects received a single dose of oral lefamulin [immediate-release (IR) tablet, 1 × 600 mg] in a fasted and fed state, oral lefamulin (capsule, 3 × 200 mg) in a fasted state, and iv lefamulin in a fasted state. In Study 3, a three-period crossover study, healthy males received a single oral lefamulin dose (IR) in the following states: fasted, fasted followed by a high-calorie meal 1 h post-dose, and fed. Study 4 had two parts; in part A, healthy males received a single lefamulin dose (IR) in a fasted and fed state; in part B, subjects received repeated doses of lefamulin (IR, q12h) or placebo. Adverse events (AEs) were recorded in each study.
RESULTS


Single and repeated dosing of iv and oral lefamulin resulted in comparable exposure. Intravenous and oral lefamulin (given fasted or with a meal 1 h post-dose) resulted in bioequivalence. Bioequivalence was not established between oral lefamulin in the fed state and iv or oral administration in the fasted state. All AEs were mild or moderate in severity, no serious AEs were reported, and no participant discontinued because of an AE.
CONCLUSIONS


The PK of lefamulin supports successful switch from iv to oral therapy; lefamulin was generally well tolerated.",2019,Bioequivalence was not established between oral lefamulin in the fed state and iv or oral administration in the fasted state.,"['healthy males', 'Study 4 had two parts; in part A, healthy males', 'patients with acute bacterial skin and skin structure infections', 'healthy subjects']","['oral lefamulin [immediate-release (IR) tablet, 1\u205f×\u205f600\u2009mg] in a fasted and fed state, oral lefamulin (capsule, 3\u205f×\u205f200\u2009mg) in a fasted state, and iv lefamulin', 'oral and intravenous (iv) lefamulin', 'lefamulin (IR, q12h) or placebo', 'single lefamulin dose (IR) in a fasted and fed state', 'Intravenous and oral lefamulin', 'single oral lefamulin', 'lefamulin q12h']","['Adverse events (AEs', 'Pharmacokinetics and tolerability of lefamulin', 'tolerated']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0529393,Bioequivalence was not established between oral lefamulin in the fed state and iv or oral administration in the fasted state.,"[{'ForeName': 'Wolfgang W', 'Initials': 'WW', 'LastName': 'Wicha', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Prince', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lell', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Heilmayer', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Gelone', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, PA, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz087']
1603,30949708,Prediction of lefamulin epithelial lining fluid penetration after intravenous and oral administration using Phase 1 data and population pharmacokinetics methods.,"OBJECTIVES


Lefamulin is a semi-synthetic intravenous and oral pleuromutilin antibiotic with activity against pathogens commonly associated with community-acquired bacterial pneumonia. Using data from two Phase 1 studies, a population pharmacokinetics (PPK) model for lefamulin in plasma and epithelial lining fluid (ELF) was constructed.
METHODS


Plasma pharmacokinetic (PK) data from a crossover, bioavailability, food-effect study and plasma and ELF PK data from a tissue penetration study in normal healthy volunteers were used to construct a PPK model for lefamulin. Model development involved refinement of a previous PPK model for intravenous and oral administration, followed by application of the model to plasma and ELF data from the tissue penetration study. The ELF penetration ratio of lefamulin was determined using model-based simulations.
RESULTS


The PPK analysis data set contained 1103 plasma and 12 ELF lefamulin concentrations from 32 subjects. A three-compartment model with non-linear protein binding and two parallel absorption processes provided precise and unbiased estimated plasma concentration-time profiles. The absorption rate was slower and bioavailability was decreased after a high-fat/high-calorie meal. ELF data were well described using first-order rate constants into and out of the ELF compartment. The median predicted lefamulin total-drug ELF AUC0-24/free-drug plasma AUC0-24 ratio was ∼5:1 after intravenous or oral administration.
CONCLUSIONS


The final PPK model allowed precise characterization of plasma and ELF exposures after intravenous and oral administration. The high ELF penetration ratio suggests that the penetration of lefamulin into the effect site is rapid and extensive, irrespective of route of administration.",2019,A three-compartment model with non-linear protein binding and two parallel absorption processes provided precise and unbiased estimated plasma concentration-time profiles.,['normal healthy volunteers'],[],"['absorption rate', 'median predicted lefamulin total-drug ELF AUC0-24/free-drug plasma AUC0-24 ratio', 'bioavailability', 'ELF penetration ratio of lefamulin']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",,0.0408722,A three-compartment model with non-linear protein binding and two parallel absorption processes provided precise and unbiased estimated plasma concentration-time profiles.,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Institute for Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Wolfgang W', 'Initials': 'WW', 'LastName': 'Wicha', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria.'}, {'ForeName': 'Sujata M', 'Initials': 'SM', 'LastName': 'Bhavnani', 'Affiliation': 'Institute for Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Rubino', 'Affiliation': 'Institute for Clinical Pharmacodynamics, Schenectady, NY, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz088']
1604,30961342,Influence of prevention of caffeine citrate on cytokine profile and bronchopulmonary dysplasia in preterm infants with apnea.,"BACKGROUND


This study aims to investigate the preventive effects of caffeine citrate on cytokine profile and bronchopulmonary dysplasia (BPD) in preterm infants with apnea.
METHODS


Preterm infants with apnea who were born at less than 32 weeks of gestational age and birth weight ≤1500 g were randomly divided into caffeine citrate prevention group and caffeine citrate treatment group. Preterm infants in caffeine citrate prevention group who were at risk of developing recurrent apnea were given to caffeine citrate within 8 h after birth. Those in caffeine citrate treatment group experienced apnea after birth were given to caffeine citrate for treatment. Preterm infants in both groups were treated with the same respiratory management and other conventional therapy. After drug discontinuation, levels of cytokine profile, and incidence of BPD were compared between two groups.
RESULTS


A total of 56 preterm infants were enrolled. Differences in gestational age (P=0.11) and birth weight (P=0.251) were not statistically significant. Differences in application time of caffeine citrate (P=0.356), hour of ventilator use (P=0.152), length of stay (P=0.416) and BPD morbidity (P=1.00) between two groups were not statistically significant. At birth, there were no statistically significant in levels of IL-6 (P=0.063) and IL-8 (P=0.125) between two groups. After conventional therapy, levels of IL-6 (P=0.001) and IL-8 (P=0.001) significantly decreased in caffeine citrate prevention group compared with those in caffeine citrate treatment group.
CONCLUSIONS


Prevention usage of caffeine citrate in preterm infants with apnea could reduce the level of cytokine profile and the incidence of BPD.",2020,"After conventional therapy, levels of IL-6 (P=0.001) and IL-8 (P=0.001) significantly decreased in caffeine citrate prevention group compared with those in caffeine citrate treatment group.
","['Preterm infants with apnea who were born at less than 32 weeks of gestational age and Birth weight≤1500 g', 'A total of fifty-six preterm infants were enrolled', 'preterm infants with apnea']","['caffeine citrate', 'caffeine citrate prevention group and caffeine citrate treatment group', 'caffeine citrate prevention', 'conventional therapy']","['risk of developing recurrent apnea', 'BPD morbidity', 'cytokine profile and bronchopulmonary dysplasia', 'apnea', 'length of stay', 'IL-8', 'birth weight', 'levels of IL-6 (P=0.001) and IL-8', 'levels of cytokine profile, and incidence of BPD', 'level of cytokine profile and the incidence of BPD', 'levels of IL-6', 'cytokine profile and bronchopulmonary dysplasia (BPD']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0054436', 'cui_str': 'caffeine citrate'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0795703', 'cui_str': 'Recurrent apnea (finding)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",56.0,0.0188575,"After conventional therapy, levels of IL-6 (P=0.001) and IL-8 (P=0.001) significantly decreased in caffeine citrate prevention group compared with those in caffeine citrate treatment group.
","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Kou', 'Affiliation': 'Unit of Neonatal Intensive Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China - kcviva@126.com.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Unit of Neonatal Intensive Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhaona', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Unit of Neonatal Intensive Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Unit of Neonatal Intensive Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zunjie', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Unit of Neonatal Intensive Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Unit of Neonatal Intensive Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhengping', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Unit of Neonatal Intensive Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}]",Minerva pediatrica,['10.23736/S0026-4946.19.05428-8']
1605,30879998,"Double-blind, randomized, placebo-controlled trial of allergen-specific immunotherapy with the major allergen Alt a 1.","BACKGROUND


There have been few studies conducted on the efficacy and safety of specific immunotherapy with allergen extracts of fungi compared with other allergen extracts, and there are no data on the major allergen Alt a 1 of the fungus Alternaria alternata.
OBJECTIVES


We sought to evaluate the efficacy and safety of subcutaneous immunotherapy with 2 different doses of Alt a 1 in patients with rhinoconjunctivitis caused by sensitization to A alternata.
METHOD


We performed a multicenter, randomized, double-blind, placebo-controlled trial with Alt a 1 administered subcutaneously in patients with allergic rhinoconjunctivitis with or without controlled asthma aged 12 to 65 years. Three groups were included: the placebo group and active groups receiving 0.2 or 0.37 μg of Alt a 1 per dose. The main end point was the combined symptom and medication score. Secondary end points were cutaneous reactivity and serum IgE and IgG 4  levels to Alt a 1. Recorded adverse reactions were graded according to World Allergy Organization criteria.
RESULTS


There were significant reductions in the combined symptom and medication score for the 0.37-μg dose of Alt a 1 compared with placebo at 12 months of treatment. Reduced cutaneous reactivity and IgE levels, together with increased IgG 4  levels, were demonstrated for the 2 active groups versus the placebo group. A similar safety profile was found for both active groups compared with the placebo group. No serious adverse drug reactions were reported.
CONCLUSION


Immunotherapy with Alt a 1 was efficacious and safe, reducing the symptoms and medication consumption associated with rhinoconjunctivitis after only 1 year of treatment. The clinical benefits were associated with reduced skin reactivity and specific IgE levels and increased IgG 4  levels.",2019,"Immunotherapy with Alt a 1 was efficacious and safe, reducing the symptoms and medication consumption associated with rhinoconjunctivitis after only 1 year of treatment.","['patients with allergic rhinoconjunctivitis with or without controlled asthma aged 12 to 65\xa0years', 'patients with rhinoconjunctivitis caused by sensitization to A alternata']","['subcutaneous immunotherapy', 'placebo', 'allergen-specific immunotherapy']","['combined symptom and medication score', 'cutaneous reactivity and IgE levels', 'serious adverse drug reactions', 'skin reactivity and specific IgE levels', 'efficacy and safety', 'adverse reactions', 'cutaneous reactivity and serum IgE and IgG 4  levels to Alt a 1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}]","[{'cui': 'C0413381', 'cui_str': 'Subcutaneous immunotherapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",,0.525773,"Immunotherapy with Alt a 1 was efficacious and safe, reducing the symptoms and medication consumption associated with rhinoconjunctivitis after only 1 year of treatment.","[{'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'Tabar', 'Affiliation': 'Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Prieto', 'Affiliation': 'Hospital Universitario Dr. Peset, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Alba', 'Affiliation': 'Hospital de Manises, Valencia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nieto', 'Affiliation': 'Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Rodríguez', 'Affiliation': 'Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Torrecillas', 'Affiliation': 'Hospital Universitario Nuestra Señora del Perpetuo Socorro, Albacete, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Huertas', 'Affiliation': 'Hospital del Sureste, Arganda del Rey, Madrid, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Gómez', 'Affiliation': 'Hospital Universitario de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Fernández', 'Affiliation': 'Hospital General, Universitario de Alicante, Alicante, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Blanca', 'Affiliation': 'Hospital Regional Universitario Carlos Haya, Malaga, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez', 'Affiliation': 'Diater Laboratorios S.A., Leganés, Madrid, Spain. Electronic address: d.rodriguez@diater.com.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Palacios', 'Affiliation': 'Diater Laboratorios S.A., Leganés, Madrid, Spain.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.02.029']
1606,32410819,Phase I Study in Healthy Women of a Novel Antimycotic Vaginal Ovule Combining Econazole and Benzydamine.,"Purpose


A novel fixed-dose combination of 150 mg of econazole with 6 mg of benzydamine formulated in vaginal ovules was investigated in a randomised, double-blind, four-parallel group, tolerability, and pharmacokinetic Phase I study in healthy women.
Methods


The fixed-dose combination was compared to econazole and benzydamine single-drug formulations and with placebo after daily applications for 3 consecutive days. Safety and tolerability were evaluated recording the adverse drug reactions, local and general tolerability scores, clinical laboratory assays, and vital signs. Econazole, benzydamine, and its metabolite benzydamine N-oxide pharmacokinetics were investigated after single and multiple applications.
Results


Local reactions were generally absent. Pruritus and pain at the application site were infrequently reported. According to the subjects' evaluations, the overall tolerability of the ovules was rated as excellent or good. No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed. Very low econazole, benzydamine, and benzydamine-N-oxide concentrations were measured in plasma, though quantifiable in almost all samples.
Conclusion


The tested fixed-dose combination showed a good safety profile consistently with the known tolerability of both active substances. In addition, the confirmed low bioavailability of the drugs excludes the possibility of any accumulation effects and limits the risk of undesired systemic effects. This trial is registered at ClinicalTrials.gov with the identifier NCT02720783 last updated on 07 February 2017.",2020,"No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed.","['07 February 2017', 'Healthy Women of a Novel Antimycotic Vaginal Ovule Combining Econazole and Benzydamine', 'healthy women']","['Econazole, benzydamine', '150\u2009mg of econazole with 6\u2009mg of benzydamine', 'placebo']","['Safety and tolerability', 'Pruritus and pain', 'adverse drug reactions, local and general tolerability scores, clinical laboratory assays, and vital signs', 'Very low econazole, benzydamine, and benzydamine-N-oxide concentrations', 'laboratory parameters, vital signs, body weight, vaginal pH, or ECG', 'overall tolerability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C2718098', 'cui_str': 'Ovule'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013547', 'cui_str': 'Econazole'}, {'cui': 'C0005099', 'cui_str': 'Benzydamine'}]","[{'cui': 'C0013547', 'cui_str': 'Econazole'}, {'cui': 'C0005099', 'cui_str': 'Benzydamine'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0013547', 'cui_str': 'Econazole'}, {'cui': 'C0005099', 'cui_str': 'Benzydamine'}, {'cui': 'C0081742', 'cui_str': 'benzydamine N-oxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.138482,"No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed.","[{'ForeName': 'A F D', 'Initials': 'AFD', 'LastName': 'Di Stefano', 'Affiliation': 'CROSS Research S.A., Via F. A. Giorgioli, 14, CH-6864 Arzo, Switzerland.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Radicioni', 'Affiliation': 'CROSS Research S.A., Via F. A. Giorgioli, 14, CH-6864 Arzo, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vaccani', 'Affiliation': 'CROSS Research S.A., Via F. A. Giorgioli, 14, CH-6864 Arzo, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Caccia', 'Affiliation': 'Service for Gynaecology and Obstetrics, Ospedale Regionale di Mendrisio, Mendrisio, Switzerland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Focanti', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Salvatori', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pelacchi', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Picollo', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Rosignoli', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Olivieri', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bovi', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Comandini', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}]",Infectious diseases in obstetrics and gynecology,['10.1155/2020/7201840']
1607,30826256,Mobile health applications enhance weight loss efficacy following bariatric surgery.,"INTRODUCTION


With the epidemic of obesity numerous mobile health (mHealth) applications have been designed with the goal of facilitating weight loss. This technology has the potential to focus behavioral modification in a manner that's effective for weight loss. We examined the use of this mHealth technology in our bariatric surgery population to evaluate effects on weight loss following surgery.
METHODS


Single institution prospective randomized control trial performed at an academic center. 56 patients who recently underwent a laparoscopic sleeve gastrectomy (LSG) were enrolled into a control group with standard post-operative monitoring and a mHealth application group provided with iPad© minis with the MyFitnessPal© mHealth application. Participants were followed for 24 months. The primary outcomes were effect on weight loss as determined by excess body weight loss (%EWL) and excess BMI loss (%EBL).
RESULTS


Statistically significant differences in weight loss outcomes between the groups were present throughout the duration of the study. At 12 months, %EWL was 74.41% (control) vs 81.41% (mHealth) p value 0.047 and at 24 months, it was 59.10% (control) vs 71.47% (mHealth) p value 0.0078. %EBL findings at 12 months was 28.02% (control) vs 32.15% (mHealth) p value 0.0007 and at 24 months, it was 25.39% (control) vs 27.87% (mHealth) p value 0.048.
CONCLUSION


Our results demonstrate mHealth applications are a useful adjunct to improve and maintain weight loss following bariatric surgery. We suggest mHealth applications should be utilized following bariatric surgery for improved outcomes.",2019,"At 12 months, %EWL was 74.41% (control) vs 81.41% (mHealth) p value 0.047 and at 24 months, it was 59.10% (control) vs 71.47% (mHealth) p value 0.0078.",['56 patients who recently underwent a'],"['control group with standard post-operative monitoring and a mHealth application group provided with iPad© minis with the MyFitnessPal© mHealth application', 'laparoscopic sleeve gastrectomy (LSG', 'bariatric surgery']","['weight loss outcomes', 'weight loss as determined by excess body weight loss (%EWL) and excess BMI loss (%EBL', 'weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",56.0,0.0289077,"At 12 months, %EWL was 74.41% (control) vs 81.41% (mHealth) p value 0.047 and at 24 months, it was 59.10% (control) vs 71.47% (mHealth) p value 0.0078.","[{'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Mangieri', 'Affiliation': 'Dwight D. Eisenhower Army Medical Center, 300 East Hospital Road, Fort Gordon, GA 30905, United States. Electronic address: christopher.w.mangieri.mil@mail.mil.'}, {'ForeName': 'Rebekah J', 'Initials': 'RJ', 'LastName': 'Johnson', 'Affiliation': 'Dwight D. Eisenhower Army Medical Center, 300 East Hospital Road, Fort Gordon, GA 30905, United States. Electronic address: rebekah.j.johnson.mil@mail.mil.'}, {'ForeName': 'Lori B', 'Initials': 'LB', 'LastName': 'Sweeney', 'Affiliation': 'Dwight D. Eisenhower Army Medical Center, 300 East Hospital Road, Fort Gordon, GA 30905, United States. Electronic address: lori.b.sweeney.mil@mail.mil.'}, {'ForeName': 'Yong U', 'Initials': 'YU', 'LastName': 'Choi', 'Affiliation': 'Dwight D. Eisenhower Army Medical Center, 300 East Hospital Road, Fort Gordon, GA 30905, United States. Electronic address: yong.u.choi.mil@mail.mil.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Wood', 'Affiliation': 'Dwight D. Eisenhower Army Medical Center, 300 East Hospital Road, Fort Gordon, GA 30905, United States. Electronic address: joseph.c.wood.civ@mail.mil.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2019.01.004']
1608,30964778,EARLY VITAMIN A SUPPLEMENTATION IMPROVES THE OUTCOME OF RETINOPATHY OF PREMATURITY IN EXTREMELY PRETERM INFANTS.,"PURPOSE


This study assessed the efficacy and safety of early vitamin A (VA) supplementation to improve outcomes of retinopathy of prematurity in extremely preterm infants.
METHODS


A total of 262 eligible extremely preterm infants underwent randomization; of these, 132 were assigned to the VA group and 130 to the control group. The infants were administered a solution of VA (1,500 IU/day), added to their enteral feeds as soon as minimal feeding was introduced and continued for 28 days or until discharge.
RESULTS


With no adverse effects occurring, serum VA of the VA-supplemented infants on Days 14, 28, and postmenstrual 36 weeks was higher than that of the placebo group (P < 0.001). No signs of VA toxicity or increased intracranial pressure were reported. The VA group had lower unadjusted rates of Type 1 retinopathy of prematurity (1.6 vs. 6.9%, P = 0.030) and bronchopulmonary dysplasia (18.9 vs. 33.8%, P = 0.008) than the control group. Regression analysis revealed an association between serum VA levels and risk of Type 1 retinopathy of prematurity (beta = -2.37).
CONCLUSION


Vitamin A supplementation reduced VA deficiency in extremely preterm infants; it was associated with a decreased incidence of Type 1 retinopathy of prematurity and may also have a positive impact on reducing bronchopulmonary dysplasia.",2020,Vitamin A supplementation reduced VA deficiency in extremely preterm infants; it was associated with a decreased incidence of Type 1 retinopathy of prematurity and may also have a positive impact on reducing bronchopulmonary dysplasia.,"['extremely preterm infants', '262 eligible extremely preterm infants underwent randomization; of these, 132 were assigned to the VA group and 130 to the control group']","['early vitamin A (VA) supplementation', 'Vitamin A supplementation', 'solution of VA', 'placebo']","['unadjusted rates of Type 1 retinopathy of prematurity', 'VA toxicity or increased intracranial pressure', 'bronchopulmonary dysplasia', 'efficacy and safety']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0151740', 'cui_str': 'Intracranial Pressure Increase'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",262.0,0.227382,Vitamin A supplementation reduced VA deficiency in extremely preterm infants; it was associated with a decreased incidence of Type 1 retinopathy of prematurity and may also have a positive impact on reducing bronchopulmonary dysplasia.,"[{'ForeName': 'Huiqing', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Departments of Neonatology, and.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Cheng', 'Affiliation': ""Department of Neonatology, Children's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Zhansheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Neonatology, Shangqiu People's Hospital, Shangqiu, China.""}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002543']
1609,30970218,Supplementation with dietary ω-3 mitigates immobilization-induced reductions in skeletal muscle mitochondrial respiration in young women.,"Omega-3 (ω-3) supplementation attenuates immobilization-induced atrophy; however, the underlying mechanisms remain unclear. Since mitochondrial dysfunction and oxidative stress have been implicated in muscle atrophy, we examined whether ω-3 supplementation could mitigate disuse-mediated mitochondrial dysfunction. Healthy young women (age = 22 ± 3 yr) randomly received control ( n  = 9) or ω-3 supplementation ( n  = 11; 3 g eicosapentaenoic acid, 2 g docosahexaenoic acid) for 4 wk prior to and throughout 2 wk of single-limb immobilization. Biopsies were performed before and after 3 and 14 d of immobilization for the assessment of mitochondrial respiration, H 2 O 2  emission, and markers of ADP transport/lipid metabolism. In controls, immobilization rapidly (3 d) reduced (∼20%) ADP-stimulated mitochondrial respiration without altering ADP sensitivity or the abundance of mitochondrial proteins. Extending immobilization to 14 d did not further reduce mitochondrial coupled respiration; however, unlike following 3 d, mitochondrial proteins were reduced ∼20%. In contrast, ω-3 supplementation prevented immobilization-induced reductions in mitochondrial content and respiration throughout the immobilization period. Regardless of dietary supplement, immobilization did not alter mitochondrial H 2 O 2  emission in the presence or absence of ADP, markers of cellular redox state, mitochondrial lipid-supported respiration, or lipid-related metabolic proteins. These data highlight the rapidity of mitochondrial adaptations in response to muscle disuse, challenge the necessity for increased oxidative stress during inactivity, and establish that ω-3 supplementation preserves oxidative phosphorylation function and content during immobilization.-Miotto, P. M., McGlory, C., Bahniwal, R., Kamal, M., Phillips, S. M., Holloway, G. P. Supplementation with dietary ω-3 mitigates immobilization-induced reductions in skeletal muscle mitochondrial respiration in young women.",2019,"Extending immobilization to 14 d did not further reduce mitochondrial coupled respiration; however, unlike following 3 d, mitochondrial proteins were reduced ∼20%.","['Healthy young women (age = 22 ± 3 yr) randomly received', 'young women']","['ADP-stimulated mitochondrial respiration', 'eicosapentaenoic acid, 2 g docosahexaenoic acid', 'control ( n  = 9) or ω-3 supplementation', 'Omega-3 (ω-3) supplementation']","['skeletal muscle mitochondrial respiration', 'mitochondrial content and respiration']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",,0.0362044,"Extending immobilization to 14 d did not further reduce mitochondrial coupled respiration; however, unlike following 3 d, mitochondrial proteins were reduced ∼20%.","[{'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Miotto', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Ontario, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'McGlory', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ravninder', 'Initials': 'R', 'LastName': 'Bahniwal', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Holloway', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Ontario, Canada.'}]",FASEB journal : official publication of the Federation of American Societies for Experimental Biology,['10.1096/fj.201900095R']
1610,32410849,Pioglitazone Metformin Complex Improves Polycystic Ovary Syndrome Comorbid Psychological Distress via Inhibiting NLRP3 Inflammasome Activation: A Prospective Clinical Study.,"Objective


This study aimed at investigating the therapeutic effect and mechanism of pioglitazone metformin complex preparation (PM) in polycystic ovary syndrome (PCOS) comorbid psychological distress.
Methods


Seventy-five patients with PCOS comorbid psychological distress were randomly allocated into the PM, metformin, and placebo groups. The primary efficacy measure was the change from baseline to week 12 on the Symptom Checklist 90-R (SCL-90-R) scores. NLRP3 inflammasome, IL-1 β , IL-6, TNF- α , and biochemical parameters were determined at baseline and at week 12. The participants were required to meet the criteria for PCOS (Rotterdam, NIH) and psychological distress (any factor scores of SCL - 90 - R > 2).
Results


The participants had significantly high scores on the SCL-90-R scales of anxiety and depression. PM significantly decreased anxiety and depression symptom severity (from 2.31 ± 0.75 to 1.65 ± 0.38,  p  < 0.001, and from 2.08 ± 0.74 to 1.61 ± 0.46,  p  = 0.010, at week 12, respectively). PM significantly decreased the expression of NRPL3 and caspase-1. Patients in the PM group experienced a significant reduction in IL-1 β  (from 98.42 ± 14.38 to 71.76 ± 13.66,  p  = 0.02), IL-6 (from 87.51 ± 8.74 to 71.98 ± 15.87,  p  = 0.02), and TNF- α  (from 395.33 ± 88.55 to 281.98 ± 85.69,  p  = 0.04). PM was superior to metformin in reducing total testosterone (2.24 ± 0.74 versus 3.06 ± 0.83,  p  = 0.024, at week 12).
Conclusions


This study is the first to reveal that PM alleviates psychological distress via inhibiting NLRP3 inflammasome and improves several markers, including total testosterone.",2020,"Patients in the PM group experienced a significant reduction in IL-1 β  (from 98.42 ± 14.38 to 71.76 ± 13.66,  p  = 0.02), IL-6","['Polycystic Ovary Syndrome Comorbid Psychological Distress via Inhibiting NLRP3', 'polycystic ovary syndrome (PCOS) comorbid psychological distress', 'Methods\n\n\nSeventy-five patients with PCOS comorbid psychological distress']","['pioglitazone metformin complex preparation (PM', 'Pioglitazone Metformin Complex', 'PM, metformin, and placebo', 'metformin']","['Inflammasome Activation', 'expression of NRPL3 and caspase-1', 'Symptom Checklist 90-R (SCL-90-R) scores', 'IL-1 β', 'total testosterone', 'NLRP3 inflammasome, IL-1 β , IL-6, TNF- α , and biochemical parameters', 'anxiety and depression symptom severity', 'criteria for PCOS (Rotterdam, NIH) and psychological distress', 'SCL-90-R scales of anxiety and depression', 'IL-6']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2936529', 'cui_str': 'Inflammasome'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0534519', 'cui_str': 'Caspase-1'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",75.0,0.046925,"Patients in the PM group experienced a significant reduction in IL-1 β  (from 98.42 ± 14.38 to 71.76 ± 13.66,  p  = 0.02), IL-6","[{'ForeName': 'Qing-Jun', 'Initials': 'QJ', 'LastName': 'Guo', 'Affiliation': 'Department of Endocrinology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shan', 'Affiliation': 'Department of Traditional Chinese Medicine, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yi-Feng', 'Initials': 'YF', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Hu', 'Affiliation': 'Department of Endocrinology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Cui-Lan', 'Initials': 'CL', 'LastName': 'Huo', 'Affiliation': 'Department of Endocrinology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Jing-Yun', 'Initials': 'JY', 'LastName': 'Song', 'Affiliation': 'Department of Endocrinology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Chao-Qun', 'Initials': 'CQ', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Changning Retirement Cadre Rest Care Clinic, Garrison District Shanghai, China.'}, {'ForeName': 'Chao-Qin', 'Initials': 'CQ', 'LastName': 'Yu', 'Affiliation': 'Department of Traditional Chinese Medicine, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Endocrinology, Changhai Hospital, Naval Medical University, Shanghai, China.'}]",Mediators of inflammation,['10.1155/2020/3050487']
1611,30964238,"Anti-sebum efficacy of guava toner: A split-face, randomized, single-blind placebo-controlled study.","BACKGROUND


Guava has benefit phytochemicals that are important for skin-disorder treatment. Nevertheless, its efficacy against oily skin has never been reported.
AIMS


The guava toner was developed and clinical evaluated.
METHODS


The base toner was formulated, accelerated stability tested, and sensory-evaluated in 10 volunteers. The highest preference base was incorporated with guava extract, stability examined, and skin irritation assessed in 21 volunteers by a single application close patch test. Anti-sebum efficacy was split-face, randomized, single-blind placebo-controlled evaluated in 21 volunteers for 28 days and monitored by Sebutape ®  on forehead and nose.
RESULTS


The stable toner base with the greatest preference (83.20 ± 1.85%) was incorporated with 3%, 4.5%, and 6% of guava extract. The toners were stable with none of skin irritation. The toner with 6% guava extract was selected for efficacy evaluation. Guava toner significantly reduced oiliness of forehead (13.10 ± 3.67%, P < 0.05) and nose (21.43 ± 3.21%, P < 0.001) better than the base toner. The activity on nose was significantly noted (10.72 ± 3.51%, P < 0.05) since the 3rd week of application.
CONCLUSIONS


Anti-sebum guava toner was efficiently evidence approved and suitable for a daily application to improve the efficacy.",2019,"Guava toner significantly reduced oiliness of forehead (13.10 ± 3.67%, P < 0.05) and nose (21.43 ± 3.21%, P < 0.001) better than the base toner.","['21 volunteers for 28\xa0days and monitored by Sebutape ®  on forehead and nose', '21 volunteers', '10 volunteers']","['guava toner', 'placebo']","['oiliness of forehead', 'activity on nose']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C0028429', 'cui_str': 'Nose'}]","[{'cui': 'C0453279', 'cui_str': 'Guava'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0028429', 'cui_str': 'Nose'}]",21.0,0.0311736,"Guava toner significantly reduced oiliness of forehead (13.10 ± 3.67%, P < 0.05) and nose (21.43 ± 3.21%, P < 0.001) better than the base toner.","[{'ForeName': 'Pongpaka', 'Initials': 'P', 'LastName': 'Pongsakornpaisan', 'Affiliation': 'School of Cosmetic Science, Mae Fah Luang University, Chiang Rai, Thailand.'}, {'ForeName': 'Nattaya', 'Initials': 'N', 'LastName': 'Lourith', 'Affiliation': 'School of Cosmetic Science, Mae Fah Luang University, Chiang Rai, Thailand.'}, {'ForeName': 'Mayuree', 'Initials': 'M', 'LastName': 'Kanlayavattanakul', 'Affiliation': 'School of Cosmetic Science, Mae Fah Luang University, Chiang Rai, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.12943']
1612,30972693,"Periodic breathing in healthy young adults in normobaric hypoxia equivalent to 3500 m, 4500 m, and 5500 m altitude.","PURPOSE


The occurrence of periodic breathing (PB) at high altitude during sleep and the quality of sleep are individually different and influenced by multiple factors including sex. Although poor sleep quality at high altitude might not be directly linked to oxygen desaturations, the PB upsurge at high altitude leads to significant oscillations in oxygen saturation.
METHODS


Thirty-three students were recruited. Participants were randomly assigned to three groups (A, B, C) sleeping one full night in a dormitory with normobaric hypoxia at a F I O2 of 14.29% (A), a F I O2 of 12.47% (B), or a F I O2 of 10.82% (C). Full polysomnography was performed in each participant.
RESULTS


Mean total sleeping time decreased significantly with increasing hypoxia (p < 0.001). Respiratory events changed from central hypopneas to central apneas (CA) with increasing hypoxia: CA = 17.8%, 50.0%, 92.2% of AHI (37.96 events per hour (n/h), 68.55 n/h, 93.44 n/h). AHI (p = 0.014) and time duration of respiratory events (p = 0.003) were significantly different between sexes, both greater in men. REM sleep was reduced.
CONCLUSIONS


Men tend to be more prone to PB in normobaric hypoxia. Further research should implicate a longer acclimatization period around simulated 4500 m in order to find out if the exponential increase in PB between 4500 m and 5500 m could be shifted to lower hypoxic levels, i.e., higher altitudes.",2019,"AHI (p = 0.014) and time duration of respiratory events (p = 0.003) were significantly different between sexes, both greater in men.","['Thirty-three students were recruited', 'healthy young adults in normobaric hypoxia equivalent to 3500\xa0m, 4500\xa0m, and 5500\xa0m altitude']",['Periodic breathing'],"['Mean total sleeping time', 'occurrence of periodic breathing (PB', 'REM sleep', 'time duration of respiratory events']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C4517736', 'cui_str': '3500'}, {'cui': 'C4517780', 'cui_str': 'Four thousand five hundred'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}]","[{'cui': 'C1313952', 'cui_str': 'Respiration intermittent (finding)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C1313952', 'cui_str': 'Respiration intermittent (finding)'}, {'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}]",33.0,0.0129232,"AHI (p = 0.014) and time duration of respiratory events (p = 0.003) were significantly different between sexes, both greater in men.","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Pramsohler', 'Affiliation': 'Dept. of Psychology and Sports Science, Hermann Buhl Institute for Hypoxia and Sleep Medicine Research, University of Innsbruck, Ghersburgstr. 9, 83043, Bad Aibling, Germany. S.Pramsohler@gmx.net.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schilz', 'Affiliation': 'University Hospitals of Cleveland and Case University School of Medicine, 11100 Euclid Avenue, Cleveland, OH, 44106, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Patzak', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Institute for Vegetative Physiology, Chariteplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Rausch', 'Affiliation': 'Dept. of Psychology and Sports Science, Hermann Buhl Institute for Hypoxia and Sleep Medicine Research, University of Innsbruck, Ghersburgstr. 9, 83043, Bad Aibling, Germany.'}, {'ForeName': 'Nikolaus C', 'Initials': 'NC', 'LastName': 'Netzer', 'Affiliation': 'Dept. of Psychology and Sports Science, Hermann Buhl Institute for Hypoxia and Sleep Medicine Research, University of Innsbruck, Ghersburgstr. 9, 83043, Bad Aibling, Germany.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01829-z']
1613,30972702,A Q-TWiST Analysis Comparing Nivolumab and Therapy of Investigator's Choice in Patients with Recurrent/Metastatic Platinum-Refractory Squamous Cell Carcinoma of the Head and Neck.,"OBJECTIVES


In the CheckMate 141 trial (NCT02105636), nivolumab demonstrated survival, health-related quality of life, and healthcare resource utilization benefits vs single-agent therapy of investigator's choice (IC) (methotrexate, docetaxel or cetuximab) in patients with platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). We assessed between-treatment differences in quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST).
METHODS


Survival data from CheckMate 141 (nivolumab, n = 240; IC, n = 121) was partitioned into toxicity (TOX), time without symptoms or toxicity (TWiST), and relapse (REL). TOX was defined as time spent with all-cause grade 3-4 adverse events after randomization, before disease progression. TWiST was defined as time not in TOX or REL. REL was defined as time between disease progression and death. Utility values derived from three-level EuroQol five-dimensional questionnaire data from CheckMate 141 were used to calculate Q-TWiST as the utility-weighted sum of the mean duration in each health state.
RESULTS


The between-group difference in Q-TWiST score was 1.23 months (95% confidence interval 1.17-1.29) favoring nivolumab (p < 0.001). The nivolumab group experienced significantly longer mean time in TWiST (3.82 vs 2.78 months) and REL (4.02 vs 3.30 months) compared with the IC group (p < 0.001). Mean time in TOX was lower for nivolumab vs IC (0.30 vs 0.37 months, p < 0.001).
CONCLUSIONS


In CheckMate 141, nivolumab resulted in statistically significant and clinically meaningful gains (relative difference > 10%) in quality-adjusted survival vs standard of care in patients with R/M SCCHN.",2019,The between-group difference in Q-TWiST score was 1.23 months (95% confidence interval 1.17-1.29) favoring nivolumab (p < 0.001).,"['Survival data from CheckMate 141 (nivolumab, n\u2009=\u2009240; IC, n\u2009=\u2009121', 'patients with platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN', 'Patients with Recurrent/Metastatic Platinum-Refractory Squamous Cell Carcinoma of the Head and Neck']","['TWiST', ""investigator's choice (IC) (methotrexate, docetaxel or cetuximab""]","['survival, health-related quality of life, and healthcare resource utilization benefits', 'toxicity (TOX), time without symptoms or toxicity (TWiST), and relapse (REL', 'Q-TWiST score', 'quality-adjusted survival', 'TOX', 'Mean time in TOX', 'REL', 'longer mean time in TWiST', 'quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST', 'clinically meaningful gains']","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}]","[{'cui': 'C0040480', 'cui_str': 'Musculoskeletal torsion (observable entity)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0040480', 'cui_str': 'Musculoskeletal torsion (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]",,0.155391,The between-group difference in Q-TWiST score was 1.23 months (95% confidence interval 1.17-1.29) favoring nivolumab (p < 0.001).,"[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Cocks', 'Affiliation': 'Adelphi Values, Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Contente', 'Affiliation': 'Bristol-Myers Squibb, BMS House, Sanderson Road, Uxbridge, Middlesex, UB8 1DH, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Simpson', 'Affiliation': 'Adelphi Values, Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'DeRosa', 'Affiliation': 'Adelphi Values, 290 Congress Street, Boston, MA, 02210, USA.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Taylor', 'Affiliation': 'Adelphi Values, 290 Congress Street, Boston, MA, 02210, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Shaw', 'Affiliation': 'Bristol-Myers Squibb, 3401, Princeton Pike, Lawrenceville, NJ, 08648, USA. james.shaw@bms.com.'}]",PharmacoEconomics,['10.1007/s40273-019-00798-1']
1614,30874474,"Layperson Ability and Willingness to Use Hemostatic Dressings: A Randomized, Controlled Trial.","Background:  The Hartford Consensus and Stop the Bleed Campaign empower the public to stop bleeding. While evidence for civilian tourniquet use is mounting, there is limited evidence regarding the public's ability to use hemostatic dressings. This study seeks to determine if laypeople can apply hemostatic dressings, and which hemostatic dressing they can use most successfully.  Methods:  360 layperson participants in Maryland and Virginia completed 4 arms of this randomized, prospective controlled trial: plain gauze (control), z-folded gauze, s-rolled gauze, and injectable sponge (experimental) arms. Participants watched a standardized video, practiced hands-on dressing application, and were assessed applying the dressing via checklists and feedback mechanisms for pressure, timing, and packing. Participants completed pre and post questionnaires regarding willingness to use hemostatic dressings.  Results:  Overall, 202 participants (56%) applied the dressings correctly, and 83 (92%) applied the injectable sponges correctly. This is a significant difference from the other arms (p < 0.001), and OR 17.2 (95% CI 6.8 - 48.1) compared to control. 38 participants (40%) correctly applied plain gauze, while 37 (43%) and 44 (48%) participants correctly applied z-folded and s-rolled gauzes. The primary reasons for failure were not holding pressure long enough (n = 103, 65%) and not applying adequate pressure (n = 64, 41%). Participants in all arms had significant improvements in willingness to use hemostatic dressings: 154 (43.6%) participants pre vs. 344 (97.5%) post study participation (p < 0.001).  Conclusions:  More than half of laypeople can apply hemostatic dressings, and they are most successful applying injectable sponges. Brief education increases laypeople's reported willingness to use hemostatic dressings. Educators and planners should consider including injectable sponges in their Stop the Bleed programs and products.  Level of Evidence:  II (RCT with significant difference. One negative criterion for observer blinding).",2019,"Participants in all arms had significant improvements in willingness to use hemostatic dressings: 154 (43.6%) participants pre vs. 344 (97.5%) post study participation (p < 0.001).
","['38 participants (40%) correctly applied plain gauze, while 37 (43%) and 44 (48%) participants correctly applied z-folded and s-rolled gauzes', '360 layperson participants in Maryland and Virginia completed 4 arms']","['plain gauze (control), z-folded gauze, s-rolled gauze, and injectable sponge (experimental']",['willingness to use hemostatic dressings'],"[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0590323', 'cui_str': 'Gauzes (physical object)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0590323', 'cui_str': 'Gauzes (physical object)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C1705741', 'cui_str': 'Sponge (basic dose form)'}]","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}]",360.0,0.106903,"Participants in all arms had significant improvements in willingness to use hemostatic dressings: 154 (43.6%) participants pre vs. 344 (97.5%) post study participation (p < 0.001).
","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Goolsby', 'Affiliation': ''}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Rojas', 'Affiliation': ''}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Kretz', 'Affiliation': ''}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Singletary', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Klimczak', 'Affiliation': ''}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Charlton', 'Affiliation': ''}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2019.1593566']
1615,32410922,Personalization of CM Injection Protocols in Coronary Computed Tomographic Angiography (People CT Trial).,"Aim


To evaluate the performance of three contrast media (CM) injection protocols for cardiac computed tomography angiography (CCTA) based on body weight (BW), lean BW (LBW), and cardiac output (CO).  Materials and methods . A total of 327 consecutive patients referred for CCTA were randomized into one of the three CM injection protocols, where CM injection was based on either BW (112 patients), LBW (108 patients), or CO (107 patients). LBW and CO were calculated via formulas. All scans were ECG-gated and performed on a third-generation dual-source CT with 70-120 kV (automated tube voltage selection) and 100 kV qual.ref /330 mAs qual.ref . CM injection protocols were also adapted to scan time and tube voltage. The primary outcome was the proportion of patients with optimal intravascular attenuation (325-500 HU). Secondary outcomes were mean and standard deviation of intravascular attenuation values (HU), contrast-to-noise ratio (CNR), and subjective image quality with a 4-point Likert scale (1 = poor/2 = sufficient/3 = good/4 = excellent). The  t -test for independent samples was used for pairwise comparisons between groups, and a chi-square test ( χ 2) was used to compare categorical variables between groups. All  p  values were 2-sided, and a  p  < 0.05 was considered statistically significant.
Results


Mean overall HU and CNR were 423 ± 60HU/14 ± 3 (BW), 404 ± 62HU/14 ± 3 (LBW), and 413 ± 63HU/14 ± 3 (CO) with a significant difference between groups BW and LBW ( p =0.024). The proportion of patients with optimal intravascular attenuation (325-500 HU) was 83.9%, 84.3%, and 86.9% for groups BW, LBW, and CO, respectively, and between-group differences were small and nonsignificant. Mean CNR was diagnostic (≥10) in all groups. The proportion of scans with good-excellent image quality was 94.6%, 86.1%, and 90.7% in the BW, LBW, and CO groups, respectively. The difference between proportions was significant between the BW and LBW groups.
Conclusion


Personalization of CM injection protocols based on BW, LBW, and CO, and scan time and tube voltage in CCTA resulted in low variation between patients in terms of intravascular attenuation and a high proportion of scans with an optimal intravascular attenuation. The results suggest that personalized CM injection protocols based on LBW or CO have no additional benefit when compared with CM injection protocols based on BW.",2020,The results suggest that personalized CM injection protocols based on LBW or CO have no additional benefit when compared with CM injection protocols based on BW.,['327 consecutive patients referred for CCTA'],['three contrast media (CM) injection protocols for cardiac computed tomography angiography (CCTA'],"['mean and standard deviation of intravascular attenuation values (HU), contrast-to-noise ratio (CNR), and subjective image quality with a 4-point Likert scale', 'proportion of patients with optimal intravascular attenuation', 'LBW and CO', 'proportion of scans with good-excellent image quality', 'body weight (BW), lean BW (LBW), and cardiac output (CO', 'Mean CNR', 'Mean overall HU and CNR', 'BW, LBW, and CO, and scan time and tube voltage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0175730', 'cui_str': 'Tube'}]",327.0,0.0186532,The results suggest that personalized CM injection protocols based on LBW or CO have no additional benefit when compared with CM injection protocols based on BW.,"[{'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Eijsvoogel', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'B M F', 'Initials': 'BMF', 'LastName': 'Hendriks', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nelemans', 'Affiliation': 'Department of Epidemiology, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mihl', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Willigers', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Martens', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Wildberger', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}]",Contrast media & molecular imaging,['10.1155/2020/5407936']
1616,31711921,Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With Ulcerative Colitis.,"BACKGROUND & AIMS


Etrasimod (APD334) is an oral, selective sphingosine 1-phosphate receptor modulator in development for immune-mediated inflammatory disorders. We assessed the efficacy and safety of etrasimod in patients with moderately to severely active ulcerative colitis (UC).
METHODS


In a phase 2, proof-of-concept, double-blind, parallel-group study, adult outpatients with modified Mayo Clinic scores (MCSs) (stool frequency, rectal bleeding, and endoscopy findings) of 4-9, endoscopic subscores of 2 or more, and rectal bleeding subscores of 1 or more were randomly assigned to groups given once-daily etrasimod 1 mg (n = 52), etrasimod 2 mg (n = 50), or placebo (n = 54) for 12 weeks. The study was performed from October 15, 2015, through February 14, 2018, at 87 centers in 17 countries. The primary endpoint was an increase in the mean improvement in modified MCS from baseline to week 12. Secondary endpoints included the proportion of patients with endoscopic improvement (subscores of 1 or less) from baseline to week 12. Exploratory endpoints, including clinical remission, are reported in the article, although the study was statistically powered to draw conclusions only on the primary endpoint.
RESULTS


At week 12, the etrasimod 2 mg group met the primary and all secondary endpoints. Etrasimod 2 mg led to a significantly greater increase in mean improvement in modified MCS from baseline than placebo (difference from placebo, 0.99 points; 90% confidence interval, 0.30-1.68; P = .009), and etrasimod 1 mg led to an increase in mean improvement from baseline in modified MCS of 0.43 points more than placebo (90% confidence interval, reduction of 0.24 to increase of 1.11; nominal P = .15). Endoscopic improvement occurred in 41.8% of patients receiving etrasimod 2 mg vs 17.8% receiving placebo (P = .003). Most adverse events were mild to moderate. Three patients had a transient, asymptomatic, low-grade atrioventricular block that resolved spontaneously all patients had evidence of atrioventricular block before etrasimod exposure.
CONCLUSIONS


In patients with moderately to severely active ulcerative colitis, etrasimod 2 mg was more effective than placebo in producing clinical and endoscopic improvements. Further clinical development is warranted. Clinicaltrials.gov, Number: NCT02447302.",2020,"Etrasimod 2 mg led to a significantly greater increase in mean improvement in modified MCS from baseline than placebo (difference from placebo, 0.99 points; 90% CI, 0.30-1.68; P=.009), and etrasimod 1 mg led to an increase in mean improvement from baseline in modified MCS of 0.43 points more than placebo (90% CI, reduction of 0.24 to increase of 1.11; nominal P=.15).","['adult outpatients with modified Mayo Clinic scores (MCSs; stool frequency, rectal bleeding, and endoscopy findings) of 4-9, endoscopic subscores of 2 or more, and rectal bleeding subscores of 1 or more', 'Patients with Ulcerative Colitis', 'Three patients had a transient, asymptomatic, low-grade atrioventricular block that resolved spontaneously and did not recur with further dosing; 2 of the 3 patients had evidence of atrioventricular block prior to etrasimod exposure', 'October 15, 2015 through February 14, 2018 at 87 centers in 17 countries', 'patients with moderately to severely active ulcerative colitis (UC']","['placebo', 'Etrasimod']","['Endoscopic improvement', 'efficacy and safety of etrasimod', 'mean improvement in modified MCS', 'clinical remission', 'Efficacy and Safety', 'proportion of patients with endoscopic improvement (subscores of 1 or less']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0267596', 'cui_str': 'Rectal hemorrhage (disorder)'}, {'cui': 'C0438280', 'cui_str': 'Endoscopy finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0004245', 'cui_str': 'Atrioventricular Conduction Block'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.487472,"Etrasimod 2 mg led to a significantly greater increase in mean improvement in modified MCS from baseline than placebo (difference from placebo, 0.99 points; 90% CI, 0.30-1.68; P=.009), and etrasimod 1 mg led to an increase in mean improvement from baseline in modified MCS of 0.43 points more than placebo (90% CI, reduction of 0.24 to increase of 1.11; nominal P=.15).","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California San Diego, La Jolla, California. Electronic address: wsandborn@ucsd.edu.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Department of Gastroenterology, Nancy University Hospital, Lorraine University, Vandoeuvre-lès-Nancy, France.'}, {'ForeName': 'Jinkun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Arena Pharmaceuticals, Inc, San Diego, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chiorean', 'Affiliation': 'Division of Gastroenterology, Virginia Mason Medical Center, Seattle, Washington.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Vermeire', 'Affiliation': 'Department of Gastroenterology & Hepatology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Lee', 'Affiliation': 'University of Washington Medical Center, Seattle, Washington.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Kühbacher', 'Affiliation': 'Asklepios Westklinikum Hamburg and Christian Albrechts University, Hamburg, Germany.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Yacyshyn', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Cabell', 'Affiliation': 'Arena Pharmaceuticals, Inc, San Diego, California.'}, {'ForeName': 'Snehal U', 'Initials': 'SU', 'LastName': 'Naik', 'Affiliation': 'Arena Pharmaceuticals, Inc, San Diego, California.'}, {'ForeName': 'Preston', 'Initials': 'P', 'LastName': 'Klassen', 'Affiliation': 'Arena Pharmaceuticals, Inc, San Diego, California.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Panés', 'Affiliation': 'Hospital Clinic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.'}]",Gastroenterology,['10.1053/j.gastro.2019.10.035']
1617,32410951,Angiotensin II-Type I Receptor Antagonism Does Not Influence the Chemoreceptor Reflex or Hypoxia-Induced Central Sleep Apnea in Men.,"Components of the renin-angiotensin system (RAS) situated within the carotid body or central nervous system may promote hypoxia-induced chemoreceptor reflex sensitization or central sleep apnea (CSA). We determined if losartan, an angiotensin-II type-I receptor (AT 1 R) antagonist, would attenuate chemoreceptor reflex sensitivity before or after 8 h of nocturnal hypoxia, and consequently CSA severity. In a double-blind, randomized, placebo-controlled, crossover protocol, 14 men (age: 25 ± 2 years; BMI: 24.6 ± 1.1 kg/m 2 ; means ± SEM) ingested 3 doses of either losartan (50 mg) or placebo every 8 h. Chemoreceptor reflex sensitivity was assessed during hypoxic and hyperoxic hypercapnic ventilatory response (HCVR) tests and during six-20s hypoxic apneas before and after 8 h of sleep in normobaric hypoxia (F  I  O 2  = 0.135). Loop gain was assessed from a ventilatory control model fitted to the ventilatory pattern of CSA recorded during polysomnography. Prior to nocturnal hypoxia, losartan had no effect on either the hyperoxic (losartan: 3.6 ± 1.1, placebo: 4.0 ± 0.6 l/min/mmHg;  P  = 0.9) or hypoxic HCVR (losartan: 5.3 ± 1.4, placebo: 5.7 ± 0.68 l/min/mmHg;  P  = 1.0). Likewise, losartan did not influence either the hyperoxic (losartan: 4.2 ± 1.3, placebo: 3.8 ± 1.1 l/min/mmHg;  P  = 0.5) or hypoxic HCVR (losartan: 6.6 ± 1.8, placebo: 6.3 ± 1.5 l/min/mmHg;  P  = 0.9) after nocturnal hypoxia. Cardiorespiratory responses to apnea and participants' apnea hypopnea indexes during placebo and losartan were similar (73 ± 15 vs. 75 ± 14 events/h;  P  = 0.9). Loop gain, which correlated with CSA severity ( r  = 0.94,  P  < 0.001), was similar between treatments. In summary, in young healthy men, hypoxia-induced CSA severity is strongly associated with loop gain, but the AT 1 R does not modulate chemoreceptor reflex sensitivity before or after 8 h of nocturnal hypoxia.",2020,"Prior to nocturnal hypoxia, losartan had no effect on either the hyperoxic (losartan: 3.6 ± 1.1, placebo: 4.0 ± 0.6 l/min/mmHg;  P  = 0.9) or hypoxic HCVR (losartan: 5.3 ± 1.4, placebo: 5.7 ± 0.68 l/min/mmHg;  P  = 1.0).","['14 men (age: 25 ± 2 years; BMI: 24.6 ± 1.1 kg/m 2 ; means ± SEM) ingested 3 doses of either', 'young healthy men', 'Men']","['losartan, an angiotensin-II type-I receptor (AT 1 R) antagonist', 'Angiotensin II-Type I Receptor Antagonism', 'hyperoxic (losartan', 'losartan', 'placebo and losartan', 'placebo']","['CSA severity', 'chemoreceptor reflex sensitivity', ""Cardiorespiratory responses to apnea and participants' apnea hypopnea indexes"", 'hypoxic and hyperoxic hypercapnic ventilatory response (HCVR) tests']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0232041', 'cui_str': 'Chemoreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.124751,"Prior to nocturnal hypoxia, losartan had no effect on either the hyperoxic (losartan: 3.6 ± 1.1, placebo: 4.0 ± 0.6 l/min/mmHg;  P  = 0.9) or hypoxic HCVR (losartan: 5.3 ± 1.4, placebo: 5.7 ± 0.68 l/min/mmHg;  P  = 1.0).","[{'ForeName': 'Courtney V', 'Initials': 'CV', 'LastName': 'Brown', 'Affiliation': 'Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science, University of British Columbia - Okanagan, Kelowna, BC, Canada.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Boulet', 'Affiliation': 'Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science, University of British Columbia - Okanagan, Kelowna, BC, Canada.'}, {'ForeName': 'Tyler D', 'Initials': 'TD', 'LastName': 'Vermeulen', 'Affiliation': 'Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science, University of British Columbia - Okanagan, Kelowna, BC, Canada.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Richard J A', 'Initials': 'RJA', 'LastName': 'Wilson', 'Affiliation': 'Department of Physiology and Pharmacology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Najib T', 'Initials': 'NT', 'LastName': 'Ayas', 'Affiliation': 'Sleep Disorders Program, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Floras', 'Affiliation': 'University Health Network and Sinai Health System Division of Cardiology, Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Glen E', 'Initials': 'GE', 'LastName': 'Foster', 'Affiliation': 'Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science, University of British Columbia - Okanagan, Kelowna, BC, Canada.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00382']
1618,30797634,Live attenuated enterotoxigenic Escherichia coli (ETEC) vaccine with dmLT adjuvant protects human volunteers against virulent experimental ETEC challenge.,"BACKGROUND


There is no licensed vaccine against enterotoxigenic Escherichia coli (ETEC), a major cause of diarrhea-associated morbidity and mortality among infants and children in low-income countries and travelers. The results of this vaccination/challenge study demonstrate strong protection by an attenuated ETEC vaccine candidate, ACE527, when co-administered with a mucosal adjuvant, the double-mutant heat-labile toxin (dmLT) of ETEC.
METHODS


Sixty healthy adults participated in a randomized, placebo-controlled, double-blind study with three doses of lyophilized ACE527 (∼3 × 10 9  of each strain per dose) administered orally with or without dmLT adjuvant (25 µg/dose). Six months later, 36 of these volunteers and a control group of 21 unvaccinated volunteers were challenged with virulent ETEC strain H10407. The primary outcome was severe diarrhea, defined as passing >800 g of unformed stools during the inpatient period following challenge.
FINDINGS


The vaccine was well tolerated and induced robust immune responses to key antigens. The protective efficacy (PE) against the primary outcome of severe diarrhea was 65.9% (95% confidence interval [CI] 5.4-87.7, p = 0.003). Among subjects receiving the adjuvanted vaccine, the attack rate of severe diarrhea was 23.1, while in unimmunized controls it was 67.7%. The PE against diarrhea of any severity was 58.5% (95% CI 3.8- 82.1, p = 0.016). There was a strong inverse correlation between shedding of the vaccine strain after either of the first two doses and absence of severe diarrhea upon challenge (RR = 0.29, 95% CI 0.08-1.05, p = 0.041). Challenge strain shedding was 10-fold lower in those receiving the adjuvant than in those receiving vaccine alone. The unadjuvanted vaccine was not protective (PE = 23.1%).
INTERPRETATION


The results of this study support further development of ACE527 + dmLT as a vaccine for children in endemic countries and travelers. This is the first clinical demonstration that dmLT can contribute significantly to vaccine efficacy and may warrant testing with other oral vaccines. (ClinicalTrials.gov registration: NCT01739231).",2019,"The PE against diarrhea of any severity was 58.5% (95% CI 3.8- 82.1, p = 0.016).",['Sixty healthy adults'],"['Live attenuated enterotoxigenic Escherichia coli (ETEC) vaccine', 'ACE527\u202f+\u202fdmLT', 'placebo', 'lyophilized ACE527 (∼3\u202f×\u202f10 9  of each strain per dose) administered orally with or without dmLT adjuvant']","['PE against diarrhea of any severity', 'Challenge strain shedding', 'attack rate of severe diarrhea', 'severe diarrhea', 'protective efficacy (PE', 'severe diarrhea, defined as passing >800\u202fg of unformed stools']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0580797', 'cui_str': 'E coli, Enterotoxigenic'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C1443924', 'cui_str': 'Severe diarrhea'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0015733', 'cui_str': 'Feces'}]",60.0,0.398969,"The PE against diarrhea of any severity was 58.5% (95% CI 3.8- 82.1, p = 0.016).","[{'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Harro', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Louis Bourgeois', 'Affiliation': 'PATH, Washington, DC, USA. Electronic address: lbourgeois@path.org.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sack', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'DeNearing', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Brubaker', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Maier', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fix', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Dally', 'Affiliation': 'The Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Subhra', 'Initials': 'S', 'LastName': 'Chakraborty', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clements', 'Affiliation': 'Tulane University, School of Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Ingelise', 'Initials': 'I', 'LastName': 'Saunders', 'Affiliation': 'TDVaccines, Odense, Denmark.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Darsley', 'Affiliation': 'MD Biologic Ltd., Cambridge, United Kingdom.'}]",Vaccine,['10.1016/j.vaccine.2019.02.025']
1619,30950970,COMPARISON OF INTRAVITREAL DEXAMETHASONE IMPLANT AND AFLIBERCEPT IN PATIENTS WITH TREATMENT-NAIVE DIABETIC MACULAR EDEMA WITH SEROUS RETINAL DETACHMENT.,"PURPOSE


To compare the efficacy and safety of intravitreal dexamethasone (DEX) implant versus aflibercept in patients with treatment-naive diabetic macular edema with inflammatory biomarkers.
METHODS


Ninety-eight eyes of 62 treatment-naive patients with diabetic macular edema with serous retinal detachment and hyperreflective foci were enrolled. Each patient was randomized to receive either aflibercept or DEX implant treatment. The treatment protocol included 3 monthly injections of 2 mg of aflibercept as a loading phase in the anti-vascular endothelial growth factor group and 0.7 mg of DEX implant in the DEX group and then pro re nata treatment. Primary outcome measures were mean changes in visual acuity and central retinal thickness at the end of the 12-month follow-up.
RESULTS


Forty-eight eyes of 29 patients were received DEX implant, and 50 eyes of 33 patients received the aflibercept injection. Mean central retinal thickness decreased from 615.2 µm at baseline to 297.7 µm at 12 months in the DEX group (P < 0.001) and from 576.5 µm to 367.4 µm in the aflibercept group (P < 0.001). Except for the first month, mean central retinal thickness reduction was significantly higher in the DEX group (P < 0.05, Mann-Whitney U Test). Visual acuity improved significantly at the end of the follow-ups (46.3-52.7 Early Treatment Diabetic Retinopathy Study letters in the DEX group and 47.5-56.8 Early Treatment Diabetic Retinopathy Study letters in the aflibercept group at 12 months, P < 0.001, paired-sample t-test). Adjusting by baseline values, the increase in mean visual acuity during the 12-month follow-ups favored the aflibercept group (P < 0.01), 25% of the DEX-treated eyes and 42% of the aflibercept treated eyes experienced 10 or more Early Treatment Diabetic Retinopathy Study letters visual gain (P: 0.058). The DEX group received significantly fewer (2.6 vs. 7.2) injections (P: 0.001).
CONCLUSION


It was observed that the both of DEX implant and aflibercept were effective and safe in treatment-naive diabetic macular edema patients with inflammatory phenotype. Anatomical results were found to be better in the DEX group, and functional results were found to be better in the aflibercept group. In pseudophakic eyes, the functional superiority of aflibercept ceased to exist, and the low number of injections in the DEX implant group was seen as an advantage.",2020,"Except for the first month, mean central retinal thickness reduction was significantly higher in the DEX group (P < 0.05, Mann-Whitney U Test).","['diabetic macular edema patients with inflammatory phenotype', 'Ninety-eight eyes of 62 treatment-naive patients with diabetic macular edema with serous retinal detachment and hyperreflective foci were enrolled', 'patients with treatment-naive diabetic macular edema with inflammatory biomarkers', 'WITH TREATMENT-NAIVE DIABETIC MACULAR EDEMA WITH SEROUS RETINAL DETACHMENT', 'Forty-eight eyes of 29 patients']","['intravitreal dexamethasone (DEX) implant versus aflibercept', 'DEX', 'aflibercept injection', 'aflibercept or DEX', 'aflibercept', 'DEX implant', 'DEX implant and aflibercept']","['Early Treatment Diabetic Retinopathy Study letters visual gain', 'mean visual acuity', 'Mean central retinal thickness', 'Visual acuity', 'mean changes in visual acuity and central retinal thickness at the end of the 12-month follow-up', 'efficacy and safety', 'mean central retinal thickness reduction']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0154822', 'cui_str': 'Exudative retinal detachment'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",29.0,0.0251242,"Except for the first month, mean central retinal thickness reduction was significantly higher in the DEX group (P < 0.05, Mann-Whitney U Test).","[{'ForeName': 'Cemal', 'Initials': 'C', 'LastName': 'Ozsaygili', 'Affiliation': 'Kayseri City Hospital, Kocasinan, Kayseri, Turkey.'}, {'ForeName': 'Necati', 'Initials': 'N', 'LastName': 'Duru', 'Affiliation': ''}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002537']
1620,30947942,1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve.,"OBJECTIVES


The purpose of this study is to report the 1-year results of the CENTERA-EU trial.
BACKGROUND


The CENTERA transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, California) is a low-profile (14-F eSheath compatible), self-expanding nitinol valve, with a motorized delivery system allowing for repositionability. The 30-day results of the CENTERA-EU trial demonstrated the short-term safety and effectiveness of the valve.
METHODS


Implantations were completed in 23 centers in Europe, Australia, and New Zealand. Transfemoral access was used in all patients. Echocardiographic outcomes were adjudicated by a core laboratory at baseline, discharge, 30 days, 6 months, and 1 year. Major adverse clinical events were adjudicated by an independent clinical events committee.
RESULTS


Between March 2015 and July 2016, 203 high-risk patients (age 82.7 ± 5.5 years, 67.5% women, 68.0% New York Heart Association functional class III or IV, Society of Thoracic Surgeons score 6.1 ± 4.2%) with severe, symptomatic aortic stenosis underwent transcatheter aortic valve replacement with the CENTERA THV. The primary endpoint of the study was 30-day mortality (1.0%). At 1 year, overall mortality was 9.1%, cardiovascular mortality was 4.6%, disabling stroke was 4.1%, new permanent pacemakers were implanted in 6.5% of patients at risk, and cardiac-related rehospitalization was 6.8%. Hemodynamic parameters were stable at 1 year, with a mean aortic valve gradient of 8.1 ± 4.7 mm Hg, a mean effective orifice area of 1.7 ± 0.42 cm 2 , and no incidences of severe or moderate aortic regurgitation.
CONCLUSIONS


The CENTERA-EU trial demonstrated mid-term safety and effectiveness of the CENTERA THV, with low mortality, sustained improvements in hemodynamic performances, and low incidence of permanent pacemaker implantations in high-risk patients with symptomatic aortic stenosis. (Safety and Performance of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve [CENTERA-2]; NCT02458560).",2019,"At 1 year, overall mortality was 9.1%, cardiovascular mortality was 4.6%, disabling stroke was 4.1%, new permanent pacemakers were implanted in 6.5% of patients at risk, and cardiac-related rehospitalization was 6.8%.","['Implantations were completed in 23 centers in Europe, Australia, and New Zealand', 'Between March 2015 and July 2016, 203 high-risk patients (age 82.7 ± 5.5 years, 67.5% women, 68.0% New York Heart Association functional class III or IV, Society of Thoracic Surgeons score 6.1 ± 4.2%) with severe, symptomatic aortic stenosis underwent transcatheter aortic valve replacement with the CENTERA THV', 'high-risk patients with symptomatic aortic stenosis']",['transcatheter heart valve (THV'],"['Hemodynamic parameters', '30-day mortality', 'overall mortality', 'disabling\xa0stroke', 'severe or moderate aortic regurgitation', 'cardiovascular mortality']","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441887', 'cui_str': 'Class 3 (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0278626', 'cui_str': 'Thoracic surgeon (occupation)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach (qualifier value)'}, {'cui': 'C0018826', 'cui_str': 'Cardiac Valves'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0003504', 'cui_str': 'Aortic Incompetence'}]",,0.0546619,"At 1 year, overall mortality was 9.1%, cardiovascular mortality was 4.6%, disabling stroke was 4.1%, new permanent pacemakers were implanted in 6.5% of patients at risk, and cardiac-related rehospitalization was 6.8%.","[{'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchétché', 'Affiliation': 'Groupe Cardiovasculaire Interventionnel, Clinique Pasteur, Toulouse, France. Electronic address: d.tchetche@clinique-pasteur.com.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'A Markus', 'Initials': 'AM', 'LastName': 'Kasel', 'Affiliation': 'Department of Cardiovascular Diseases, German Heart Center, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schaefer', 'Affiliation': 'Department of Cardiology, Marienkrankenhaus, Hamburg, Germany.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Worthley', 'Affiliation': 'Department of Cardiovascular Medicine, Royal Adelaide Hospital, Adelaide Australia.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Linke', 'Affiliation': 'Department of Internal Medicine and Cardiology, Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': 'Cardiology Department, Heart Center and Leipzig Heart Institute, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Herve', 'Initials': 'H', 'LastName': 'Le Breton', 'Affiliation': 'Service de Cardiologie, CHU Rennes, Rennes, France; U1099, INSERM, Rennes, France; LTSI, Université de Rennes 1, Rennes, France.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Søndergaard', 'Affiliation': 'Cardiology Department, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Spence', 'Affiliation': 'Cardiology Department, Royal Victoria Hospital, Belfast, United Kingdom.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Petronio', 'Affiliation': 'Cardiothoracic and Vascular Department, Ospedale di Cisanelo, Pisa, Italy.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Baumgartner', 'Affiliation': 'Department of Cardiology III: Adult Congenital and Valvular Heart Disease, University Hospital Muenster, Münster, Germany.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Hovorka', 'Affiliation': 'Statistics Department, Edwards Lifesciences, Prague, Czech Republic.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Blanke', 'Affiliation': 'Department of Radiology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Reichenspurner', 'Affiliation': 'Department of Cardiovascular Surgery, University Heart Center, Hamburg, Germany.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.01.231']
1621,30948288,"Intravenous vs Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty: A Randomized, Blinded Trial.","BACKGROUND


Multimodal analgesia including acetaminophen is increasingly popular for analgesia after total hip arthroplasty (THA). Intravenous (IV) administration of acetaminophen has pharmacokinetic benefits, but unclear clinical advantages. The authors hypothesized that IV acetaminophen would reduce pain with activity, opioid usage, or opioid-related side effects, compared to oral acetaminophen.
METHODS


In this double-blinded, randomized, controlled trial, 154 THA patients received either IV or oral acetaminophen as part of a comprehensive opioid-sparing multimodal analgesia strategy. Primary outcomes were pain with physical therapy on postoperative day (POD) 1, opioid side effects (POD 1), and cumulative opioid use.
RESULTS


There was no difference in opioid side effects, pain scores, or opioid use between the groups.
CONCLUSION


Patients in both groups had low pain scores, minimal opioid side effects, and limited opioid usage (corresponding to 6 doses of tramadol 100 mg over 3 days). This highlights multimodal analgesia as an effective method of pain control for THA.",2019,"There was no difference in opioid side effects, pain scores, or opioid use between the groups.
","['After Total Hip Arthroplasty', '154 THA patients', 'total hip arthroplasty (THA']","['tramadol', 'comprehensive opioid-sparing multimodal analgesia strategy', 'Intravenous vs Oral Acetaminophen', 'IV or oral acetaminophen', 'acetaminophen']","['pain with physical therapy on postoperative day (POD', 'opioid side effects (POD 1), and cumulative opioid use', 'opioid side effects, pain scores, or opioid use', 'pain with activity, opioid usage, or opioid-related side effects', 'low pain scores, minimal opioid side effects']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}]",154.0,0.485813,"There was no difference in opioid side effects, pain scores, or opioid use between the groups.
","[{'ForeName': 'Geoffrey H', 'Initials': 'GH', 'LastName': 'Westrich', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Birch', 'Affiliation': 'Department of Anesthesiology, Critical Care, and Pain Management, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Ahava R', 'Initials': 'AR', 'LastName': 'Muskat', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Padgett', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Enrique A', 'Initials': 'EA', 'LastName': 'Goytizolo', 'Affiliation': 'Department of Anesthesiology, Critical Care, and Pain Management, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Mathias P', 'Initials': 'MP', 'LastName': 'Bostrom', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mayman', 'Affiliation': 'Department of Orthopedic Surgery, Adult Reconstruction and Joint Replacement Service, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Critical Care, and Pain Management, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Jacques T', 'Initials': 'JT', 'LastName': 'YaDeau', 'Affiliation': 'Department of Anesthesiology, Critical Care, and Pain Management, Hospital for Special Surgery, New York, NY.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.02.030']
1622,31809224,"Randomized, Double-Blind, Pharmacokinetic Equivalence Trial Comparing DRL-Rituximab With MabThera in Patients With Diffuse Large B-Cell Lymphoma.","PURPOSE


We sought to compare the pharmacokinetics (PKs) of DRL-rituximab (DRL_RI; potential biosimilar) and innovator rituximab MabThera (Roche, Grenzach-Wyhlen, Germany; reference medicinal product [RMP]) in patients with diffuse large B-cell lymphoma (DLBCL). Efficacy, pharmacodynamics (PDs), safety, and immunogenicity were also compared.
PATIENTS AND METHODS


We conducted a double-blind, parallel-group study in patients with untreated DLBCL who were eligible to receive cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy. Patients were randomly assigned at a one-to-one ratio to receive DRL_RI or RMP for six 21-day cycles of rituximab plus CHOP, with 18 months of follow-up after day 1, cycle 6 (C6). Primary end point was C1 PKs, measured as area under the plasma concentration-time curve from day 0 to 21 (AUC 0-21 days ) and maximum plasma concentration (C max ). Equivalence was defined as 90% CIs for the DRL_RI/RMP geometric mean ratios (GMRs) within 80% and 125%. Secondary end points included efficacy noninferiority measured by objective response rate (ORR) at C6 and event-free survival and overall survival at 87 weeks, PK equivalence at C6 and PD equivalence (rate of B-cell depletion and repletion), safety, and immunogenicity. The trial was stopped after sufficient patients for primary end point evaluation were enrolled. Secondary end points are reported as observed.
RESULTS


A total of 151 patients were randomly assigned (DRL_RI, n = 76; RMP, n = 75). DRL_RI/RMP GMRs for AUC 0-21 days  and C max  in C1 were 99.77 (90% CI, 87.60 to 113.63) and 96.19 (90% CI, 88.65 to 104.38), respectively. ORR at C6 for DRL_RI and RMP were 82.0% and 84.8%, respectively. Rates of B-cell depletion/repletion, immunogenicity, and adverse events were comparable in both groups.
CONCLUSION


DRL_RI and RMP had equivalent PKs, with comparable efficacy, PDs, safety, and immunogenicity.",2019,"-21 days  and C max  in C1 were 99.77 (90% CI, 87.60 to 113.63) and 96.19 (90% CI, 88.65 to 104.38), respectively.","['A total of 151 patients were randomly assigned (DRL_RI, n = 76; RMP, n = 75', 'Patients With Diffuse Large B-Cell Lymphoma', 'patients with untreated DLBCL who were eligible to receive', 'patients with diffuse large B-cell lymphoma (DLBCL']","['cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy', 'DRL-Rituximab With MabThera', 'rituximab plus CHOP', 'DRL_RI or RMP', 'DRL-rituximab (DRL_RI; potential biosimilar) and innovator rituximab MabThera (Roche, Grenzach-Wyhlen, Germany; reference medicinal product [RMP']","['maximum plasma concentration (C max ', 'Efficacy, pharmacodynamics (PDs), safety, and immunogenicity', 'efficacy noninferiority measured by objective response rate (ORR) at C6 and event-free survival and overall survival at 87 weeks, PK equivalence at C6 and PD equivalence (rate of B-cell depletion and repletion), safety, and immunogenicity', 'Rates of B-cell depletion/repletion, immunogenicity, and adverse events', 'efficacy, PDs, safety, and immunogenicity', 'ORR at C6 for DRL_RI and RMP', 'C1 PKs, measured as area under the plasma concentration-time curve', 'DRL_RI/RMP geometric mean ratios (GMRs']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1314901', 'cui_str': 'Mabthera'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",151.0,0.444876,"-21 days  and C max  in C1 were 99.77 (90% CI, 87.60 to 113.63) and 96.19 (90% CI, 88.65 to 104.38), respectively.","[{'ForeName': 'Auro', 'Initials': 'A', 'LastName': 'Viswabandya', 'Affiliation': 'Christian Medical College, Vellore, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Vedanta Institute of Medical Sciences, Ahmedabad, India.'}, {'ForeName': 'Asis', 'Initials': 'A', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Netaji Subhash Chandra Bose Cancer Research Institute, Kolkata, India.'}, {'ForeName': 'Rajnish Vasant', 'Initials': 'RV', 'LastName': 'Nagarkar', 'Affiliation': 'Curie Manavata Cancer Centre, Nashik, India.'}, {'ForeName': 'Sonica Sachdeva', 'Initials': 'SS', 'LastName': 'Batra', 'Affiliation': ""Dr Reddy's Laboratories, Hyderabad, India.""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Lopez-Lazaro', 'Affiliation': ""Dr Reddy's Laboratories, Basel, Switzerland.""}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Kankanwadi', 'Affiliation': ""Dr Reddy's Laboratories, Basel, Switzerland.""}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': 'Christian Medical College, Vellore, India.'}]",Journal of global oncology,['10.1200/JGO.19.00248']
1623,32410952,Cerebellar Repetitive Transcranial Magnetic Stimulation and Noisy Galvanic Vestibular Stimulation Change Vestibulospinal Function.,"Background


The cerebellum strongly contributes to vestibulospinal function, and the modulation of vestibulospinal function is important for rehabilitation. As transcranial magnetic stimulation (TMS) and electrical stimulation may induce functional changes in neural systems, we investigated whether cerebellar repetitive TMS (crTMS) and noisy galvanic vestibular stimulation (nGVS) could modulate vestibulospinal response excitability. We also sought to determine whether crTMS could influence the effect of nGVS.
Methods


Fifty-nine healthy adults were recruited; 28 were randomly allocated to a real-crTMS group and 31 to a sham-crTMS group. The crTMS was conducted using 900 pulses at 1 Hz, while the participants were in a static position. After the crTMS, each participant was allocated to either a real-nGVS group or sham-nGVS group, and nGVS was delivered (15 min., 1 mA; 0.1-640 Hz) while patients were in a static position. The H-reflex ratio (with/without bilateral bipolar square wave pulse GVS), which reflects vestibulospinal excitability, was measured at pre-crTMS, post-crTMS, and post-nGVS.
Results


We found that crTMS alone and nGVS alone have no effect on H-reflex ratio but that the effect of nGVS was obtained after crTMS.
Conclusion


crTMS and nGVS appear to act as neuromodulators of vestibulospinal function.",2020,"After the crTMS, each participant was allocated to either a real-nGVS group or sham-nGVS group, and nGVS was delivered (15 min.",['Methods\n\n\nFifty-nine healthy adults were recruited; 28'],"['Cerebellar Repetitive Transcranial Magnetic Stimulation and Noisy Galvanic Vestibular Stimulation Change Vestibulospinal Function', 'real-crTMS group and 31 to a sham-crTMS', 'real-nGVS group or sham-nGVS group, and nGVS', 'cerebellar repetitive TMS (crTMS) and noisy galvanic vestibular stimulation (nGVS', 'transcranial magnetic stimulation (TMS) and electrical stimulation']",['H-reflex ratio'],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0018447', 'cui_str': 'H-reflex'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",59.0,0.112908,"After the crTMS, each participant was allocated to either a real-nGVS group or sham-nGVS group, and nGVS was delivered (15 min.","[{'ForeName': 'Akiyoshi', 'Initials': 'A', 'LastName': 'Matsugi', 'Affiliation': 'Faculty of Rehabilitation, Shijonawate Gakuen University, Daito, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Douchi', 'Affiliation': 'Department of Rehabilitation, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Rikiya', 'Initials': 'R', 'LastName': 'Hasada', 'Affiliation': 'Department of Rehabilitation, Nagahara Hospital, Higasiosaka, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Mori', 'Affiliation': 'Department of Neuromodulation and Neurosurgery, Graduate School of Medicine, Osaka University, Osaka, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Faculty of Health Sciences, Kio University, Koryo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Yoshida', 'Affiliation': 'Institute of Rehabilitation Science, Tokuyukai Medical Corporation, Toyonaka, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Nishishita', 'Affiliation': 'Institute of Rehabilitation Science, Tokuyukai Medical Corporation, Toyonaka, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hosomi', 'Affiliation': 'Department of Neuromodulation and Neurosurgery, Graduate School of Medicine, Osaka University, Osaka, Japan.'}, {'ForeName': 'Youichi', 'Initials': 'Y', 'LastName': 'Saitoh', 'Affiliation': 'Department of Neuromodulation and Neurosurgery, Graduate School of Medicine, Osaka University, Osaka, Japan.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00388']
1624,30948492,"Phase II study of carfilzomib, thalidomide, and low-dose dexamethasone as induction and consolidation in newly diagnosed, transplant eligible patients with multiple myeloma; the Carthadex trial.","This is a phase II dose escalation trial of carfilzomib in combination with thalidomide and dexamethasone for induction and consolidation in transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). The results of four dose levels are reported. Induction therapy consisted of four cycles of carfilzomib 20/27 mg/m 2  (n=50), 20/36 mg/m 2  (n=20), 20/45 mg/m 2  (n=21), and 20/56 mg/m 2  (n=20) on days 1, 2, 8, 9, 15, 16 of a 28-day cycle; thalidomide 200 mg on day 1 through 28 and dexamethasone 40 mg weekly. Induction therapy was followed by high-dose melphalan and autologous stem cell transplantation and consolidation therapy with four cycles of carfilzomib, thalidomide and dexamethasone in the same schedule except a lower dose of thalidomide (50 mg). Very good partial response rate or better and complete response rate or better after induction therapy were 65% and 18%, respectively, increasing to 86% and 63%, respectively, after consolidation therapy. In all cohorts combined, after a median follow up of 58.7 months, median progression-free survival was 58 months (95%CI: 45-67 months). Median overall survival was 83 months (95%CI: 83 months-not reached). Grade 3/4 adverse events consisted mainly of infections, respiratory disorders, skin and vascular disorders in 11%, 8%, 9%, and 9%, respectively. Grade 3 polyneuropathy was only reported in one patient. Cardiac events were limited: grade 3/4 in 5% of patients. Carfilzomib, thalidomide and dexamethasone as induction and consolidation treatment after high-dose melphalan and autologous stem cell transplantation is highly efficacious and safe in transplant-eligible patients with NDMM. This study was registered as #NTR2422 at  http://www.trialregister.nl .",2019,"Very good partial response rate or better and complete response rate or better after induction therapy were 65% and 18% respectively, increasing to 86% and 63% respectively after consolidation therapy.","['transplant-eligible patients with newly diagnosed multiple myeloma', 'newly diagnosed, transplant eligible patients with multiple myeloma, the carthadex trial']","['thalidomide', 'carfilzomib, thalidomide, and low-dose dexamethasone', 'carfilzomib, thalidomide and dexamethasone', 'carfilzomib', 'melphalan and autologous stem cell transplantation', 'Carfilzomib, thalidomide and dexamethasone', 'thalidomide and dexamethasone', 'melphalan and autologous stem cell transplantation and consolidation therapy', 'dexamethasone']","['median progression-free survival', 'Cardiac events', 'Grade 3/4 adverse events consisted mainly of infections, respiratory disorders, skin and vascular disorders', 'Median overall survival', 'partial response rate or better and complete response rate']","[{'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035204', 'cui_str': 'Respiration Disorders'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.0738866,"Very good partial response rate or better and complete response rate or better after induction therapy were 65% and 18% respectively, increasing to 86% and 63% respectively after consolidation therapy.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wester', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands r.wester@erasmusmc.nl.'}, {'ForeName': 'Bronno', 'Initials': 'B', 'LastName': 'van der Holt', 'Affiliation': 'HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Emelie', 'Initials': 'E', 'LastName': 'Asselbergs', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Department of Hematology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Marie Jose', 'Initials': 'MJ', 'LastName': 'Kersten', 'Affiliation': 'HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Edo', 'Initials': 'E', 'LastName': 'Vellenga', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, University of Groningen, the Netherlands.'}, {'ForeName': 'Marinus', 'Initials': 'M', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Department of Hematology, Isala Clinics, Zwolle, the Netherlands.'}, {'ForeName': 'Okke', 'Initials': 'O', 'LastName': 'de Weerdt', 'Affiliation': 'Department of Internal Medicine, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Minnema', 'Affiliation': 'Department of Hematology, UMC Utrecht Cancer Center, Utrecht, the Netherlands.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lonergan', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palumbo', 'Affiliation': 'Department of Hematology, University of Torino, Torino, Italy.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Lokhorst', 'Affiliation': 'Department of Hematology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Broijl', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}]",Haematologica,['10.3324/haematol.2018.205476']
1625,30659664,"Evaluating the effects of switching from dutasteride to tadalafil in benign prostatic hyperplasia patients with lower urinary tract symptoms: A randomized, open-label, multicenter study.",,2019,,['benign prostatic hyperplasia patients with lower urinary tract symptoms'],"['switching from dutasteride', 'tadalafil']",[],"[{'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}]","[{'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}]",[],,0.014301,,"[{'ForeName': 'Teppei', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Hatakeyama', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Narita', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yoneyama', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Chikara', 'Initials': 'C', 'LastName': 'Ohyama', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.13908']
1626,30947936,Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial).,"OBJECTIVES


The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES).
BACKGROUND


Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation.
METHODS


This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%.
RESULTS


A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001).
CONCLUSIONS


At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent-SORT-OUT VIII; NCT02093845).",2019,"At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure.","['3 sites in western Denmark', 'Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion', '1,385 patients', 'Unselected\xa0Patients']","['EES', 'Percutaneous Coronary Intervention', 'Everolimus-eluting SYNERGY Stent', 'Everolimus-Eluting Versus Biolimus-Eluting Stents', 'BES', 'thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES', 'EES or BES']","['target lesion failure', 'composite\xa0of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0053353', 'cui_str': 'N,N-bis(2-hydroxyethyl)aminoethanesulfonic acid'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C0038126', 'cui_str': 'Stainless Steel'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",1385.0,0.168705,"At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. Electronic address: michael.maeng@ki.au.dk.'}, {'ForeName': 'Evald Høj', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Raungaard', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Kahlert', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Christian Juhl', 'Initials': 'CJ', 'LastName': 'Terkelsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Steen Dalby', 'Initials': 'SD', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Carstensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Aarøe', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Svend Eggert', 'Initials': 'SE', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Anton Boel', 'Initials': 'AB', 'LastName': 'Villadsen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jens Flensted', 'Initials': 'JF', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Troels', 'Initials': 'T', 'LastName': 'Thim', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Eftekhari', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Karsten Tange', 'Initials': 'KT', 'LastName': 'Veien', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Knud Nørregaard', 'Initials': 'KN', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Junker', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.'}, {'ForeName': 'Lisette Okkels', 'Initials': 'LO', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2018.12.036']
1627,30947938,7-Year Outcomes of a Randomized Trial Comparing the First-Generation Sirolimus-Eluting Stent Versus the New-Generation Everolimus-Eluting Stent: The RESET Trial.,"OBJECTIVES


The aim of this study was to compare 7-year outcomes between the first-generation sirolimus-eluting stent (SES) and the new-generation everolimus-eluting stent (EES) in a randomized clinical trial.
BACKGROUND


There is a scarcity of very long-term (beyond 5 years) data from clinical trials investigating whether new-generation drug-eluting stents have clear clinical advantages over first-generation drug-eluting stents.
METHODS


RESET (Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial) is the largest randomized trial comparing EES with SES (NCT01035450). Among a total of 3,197 patients in the original RESET population from 100 centers, the present extended 7-year follow-up study was conducted in 2,667 patients from 75 centers after excluding those patients enrolled from centers that denied participation. Complete 7-year follow-up was achieved in 91.5% of patients.
RESULTS


The cumulative 7-year incidence of the primary efficacy endpoint of target lesion revascularization was not significantly different between EES and SES (10.2% vs. 11.7%; hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.10; p = 0.24). The risk for the primary safety endpoint of death or myocardial infarction trended lower with EES than with SES (20.6% vs. 23.6%; hazard ratio: 0.85; 95% confidence interval: 0.72 to 1.005; p = 0.06). The cumulative 7-year incidence of definite stent thrombosis was very low and similar between EES and SES (0.9% vs. 1.0%; p = 0.82). The lower risk of EES relative to SES was significant for the composite secondary endpoint of target lesion failure (13.3% vs. 18.1%; hazard ratio: 0.72; 95% confidence interval: 0.59 to 0.88; p = 0.001).
CONCLUSIONS


During 7 years of follow-up, the risk for target lesion revascularization was not significantly different between the new-generation EES and the first-generation SES.",2019,The cumulative 7-year incidence of the primary efficacy endpoint of target lesion revascularization was not significantly different between EES and SES (10.2% vs. 11.7%; hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.10; p = 0.24).,"['3,197 patients in the original RESET population from 100 centers, the present extended 7-year follow-up study was conducted in 2,667 patients from 75\xa0centers after excluding those patients enrolled from centers that denied participation']","['Sirolimus-Eluting Stent Versus the New-Generation Everolimus-Eluting Stent', 'EES', 'sirolimus-eluting stent (SES) and the new-generation everolimus-eluting stent (EES', 'Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial']","['cumulative 7-year incidence of definite stent thrombosis', 'death or myocardial infarction', 'risk for target lesion revascularization', 'cumulative 7-year incidence of the primary efficacy endpoint of target lesion revascularization', 'lower risk of EES relative to SES', 'target lesion failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332319', 'cui_str': 'Denied (qualifier value)'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",3197.0,0.297786,The cumulative 7-year incidence of the primary efficacy endpoint of target lesion revascularization was not significantly different between EES and SES (10.2% vs. 11.7%; hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.10; p = 0.24).,"[{'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Shiomi', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Division of Cardiology, Teikyo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Kadota', 'Affiliation': 'Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Morino', 'Affiliation': 'Division of Cardiology, Iwate Medical University Hospital, Morioka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Akasaka', 'Affiliation': 'Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Division of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Takeji', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Suwa', 'Affiliation': 'Division of Cardiology, Juntendo University Shizuoka Hospital, Izonokuni, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Division of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Cardiology, Hamamatsu Medical Center, Hamamatsu, Japan.'}, {'ForeName': 'Kazuoki', 'Initials': 'K', 'LastName': 'Dai', 'Affiliation': 'Division of Cardiology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tarutani', 'Affiliation': 'Division of Cardiology, Okamura Memorial Hospital, Shimizu, Japan.'}, {'ForeName': 'Ryoji', 'Initials': 'R', 'LastName': 'Taniguchi', 'Affiliation': 'Division of Cardiology, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Nishikawa', 'Affiliation': 'Division of Cardiology, Mie Heart Center, Mie, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Cardiology, Iwaki Kyoritsu General Hospital, Iwaki, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Division of Cardiology, Tenri Hospital, Tenri, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Cardiology, Toyota Memorial Hospital, Toyota, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kawai', 'Affiliation': 'Division of Cardiology, Chikamori Hospital, Kochi, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hibi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan. Electronic address: taketaka@kuhp.kyoto-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.01.234']
1628,31820836,The effect of web-based education on Pap smear behaviours of teachers.,"OBJECTIVE


Web-based education would be useful for gaining health-related behaviours. The aim of the study was to determine the effect of web-based education on Pap smear behaviours of teachers.
METHODS


The study was an experimental-control groups with a longitudinal type. The sample consisted of 1,290 teachers (experimental: 678, control: 612). The educational videos about cervical cancer and Pap smear test were sent to the experimental group via the web. Three months later, the teachers in both groups were contacted by telephone and asked whether they have a Pap smear test or not, reasons for not having it and test results. A qualitative interview was conducted with 20 teachers in the experimental group to evaluate the web-based education.
RESULTS


At the beginning of the study, 25.9% of the teachers in both groups had a Pap smear test. After three months, having a Pap smear test was found to be statistically significantly higher in the experimental group (31.6%) than the control group (23.2%). According to the result of pathology, in the control group cervical cancer (n = 1), in the experimental group CIN1 (n = 1) and HPV53 (n = 1) were diagnosed.
CONCLUSION


The web-based education was found to be effective in Pap smear behaviours of teachers.",2020,"After three months, having a Pap smear test was found to be statistically significantly higher in the experimental group (31.6%) than the control group (23.2%).","['1,290 teachers (experimental: 678, control: 612', 'Pap smear behaviours of teachers']","['HPV53', 'web-based education']",['Pap smear test'],"[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517834', 'cui_str': '612 (qualifier value)'}, {'cui': 'C0079104', 'cui_str': 'Cervical Smears'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0079104', 'cui_str': 'Cervical Smears'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",1290.0,0.0180377,"After three months, having a Pap smear test was found to be statistically significantly higher in the experimental group (31.6%) than the control group (23.2%).","[{'ForeName': 'Aslı', 'Initials': 'A', 'LastName': 'Karakuş Selçuk', 'Affiliation': 'Faculty of Health Science, Manisa Celal Bayar University, Manisa, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Yanikkerem', 'Affiliation': 'Faculty of Health Science, Manisa Celal Bayar University, Manisa, Turkey.'}]",European journal of cancer care,['10.1111/ecc.13202']
1629,30953776,Mindfulness based stress reduction provides psychological benefit and restores immune function of women newly diagnosed with breast cancer: A randomized trial with active control.,"BACKGROUND


Women newly diagnosed with breast cancer experience psychological distress, accompanied by reduced Natural Killer Cell Activity (NKCA) and altered levels of cytokines, which may compromise cancer control. Few studies have evaluated psycho-immune outcomes of mindfulness-based stress reduction (MBSR) for women newly diagnosed with breast cancer in comparison to an active control condition.
OBJECTIVE


The purpose of this study was to determine whether MBSR benefits psychological, behavioral, and immunological function in women recently diagnosed with breast cancer.
DESIGN


After confirmation of breast cancer staging, women diagnosed with early-stage breast cancer (n = 192) were randomized to an 8-week MBSR program or an 8-week active control condition (ACC). The ACC consisted of a series of cancer recovery and health education classes. Both MBSR and the ACC were administered in group format.
METHODS


Women completed psychometric instruments and provided blood for NKCA and cytokine levels at pre-, mid-, and completion of program, as well as at 1- and 6-months post-program. One hundred and twenty four women completed all five-assessments (MBSR, n = 63; ACC, n = 61). Hierarchical linear modeling was used to analyze trajectories of outcomes over time and between groups.
RESULTS


Compared to the ACC group, women randomized to MBSR exhibited decreasing trajectories of perceived stress, fatigue, sleep disturbance, and depressive symptoms. Further, compared to women randomized to ACC, MBSR women exhibited trajectories demonstrating significantly more rapid restoration of NKCA, accompanied by lower circulating TNF-alpha levels, lower IL-6 production, and greater IFN-gamma production.
CONCLUSIONS


These results demonstrate early provision of MBSR for women newly diagnosed with breast cancer provides not only psychological benefit, but also optimizes immune function supportive of cancer control.",2019,"Compared to the ACC group, women randomized to MBSR exhibited decreasing trajectories of perceived stress, fatigue, sleep disturbance, and depressive symptoms.","['women newly diagnosed with breast cancer', 'women recently diagnosed with breast cancer', 'One hundred and twenty four women completed all five-assessments (MBSR, n\u202f=\u202f63; ACC, n\u202f=\u202f61', 'women newly diagnosed with breast cancer in comparison to an active control condition', 'Women newly diagnosed with breast cancer experience psychological distress', 'women diagnosed with early-stage breast cancer (n\u202f=\u202f192']","['MBSR', 'MBSR program or an 8-week active control condition (ACC', 'mindfulness-based stress reduction (MBSR', 'Mindfulness based stress reduction', 'ACC']","['circulating TNF-alpha levels, lower IL-6 production, and greater IFN-gamma production', 'MBSR benefits psychological, behavioral, and immunological function', 'trajectories of perceived stress, fatigue, sleep disturbance, and depressive symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C4517623', 'cui_str': '192'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0033268'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",192.0,0.0335738,"Compared to the ACC group, women randomized to MBSR exhibited decreasing trajectories of perceived stress, fatigue, sleep disturbance, and depressive symptoms.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Witek Janusek', 'Affiliation': 'Marcella Niehoff School of Nursing, Department of Health Promotion, Loyola University Chicago, Health Science Division, 2160 South First Ave., Maywood, IL 60153, United States. Electronic address: ljanuse@luc.edu.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Tell', 'Affiliation': 'Marcella Niehoff School of Nursing, Department of Health Promotion, Loyola University Chicago, Health Science Division, 2160 South First Ave., Maywood, IL 60153, United States.'}, {'ForeName': 'Herbert L', 'Initials': 'HL', 'LastName': 'Mathews', 'Affiliation': 'Department of Microbiology and Immunology, Stritch School of Medicine, Loyola University Chicago, Health Science Division, 2160 South First Ave., Maywood, IL 60153, United States.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.04.012']
1630,30931594,Cognitive-Behavioral Therapy for Anxiety in Parkinson's Disease.,"Parkinson's disease (PD) is characterized by motor symptoms, but nonmotor symptoms also significantly impair daily functioning and reduce quality of life. Anxiety is prevalent and debilitating in PD, but remains understudied and undertreated. Much affective research in PD focuses on depression rather than anxiety, and as such, there are no evidence-based treatments for anxiety in this population. Cognitive-behavioral therapy (CBT) has shown promise for treating depression in PD and may be efficacious for anxiety. This exploratory study implemented a multiple-baseline single-case experimental design to evaluate the utility and feasibility of CBT for individuals with PD who also met criteria for a DSM-5 anxiety disorder ( n  = 9). Participants were randomized to a 2-, 4-, or 6-week baseline phase, followed by 12 CBT sessions, and two post treatment assessments (immediately post treatment and 6-week follow-up). Multiple outcome measures of anxiety and depression were administered weekly during baseline and intervention. Weekly CBT sessions were conducted in-person ( n  = 5) or via secure videoconferencing ( n  = 4). At post treatment, seven of the nine participants showed significant reductions in anxiety and/or depression, with changes functionally related to treatment and most improvements maintained at 6-week follow-up. Effects of CBT on secondary outcomes varied across participants, with preliminary evidence for reduction in fear of falling. Adherence and retention were high, as were treatment satisfaction and acceptability. The findings of this pilot study provide preliminary evidence for the utility of CBT as a feasible treatment for anxiety and comorbid depressive symptoms in PD and highlight the potential of telehealth interventions for mood in this population.",2020,"Adherence and retention were high, as were treatment satisfaction and acceptability.","['individuals with PD who also met criteria for a DSM-5 anxiety disorder ( n = 9', ""Parkinson's Disease"", ""Parkinson's disease (PD""]","['secure videoconferencing', 'CBT', 'Cognitive-behavioral therapy (CBT', 'Cognitive-Behavioral Therapy']","['Adherence and retention', 'anxiety and depression', 'fear of falling', 'quality of life', 'anxiety and/or depression']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0034380'}]",,0.0349592,"Adherence and retention were high, as were treatment satisfaction and acceptability.","[{'ForeName': 'Gretchen O', 'Initials': 'GO', 'LastName': 'Reynolds', 'Affiliation': 'Boston University, MA, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Saint-Hilaire', 'Affiliation': 'Boston University Medical Center, MA, USA.'}, {'ForeName': 'Cathi A', 'Initials': 'CA', 'LastName': 'Thomas', 'Affiliation': 'Boston University Medical Center, MA, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Boston University, MA, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Cronin-Golomb', 'Affiliation': 'Boston University, MA, USA.'}]",Behavior modification,['10.1177/0145445519838828']
1631,30942862,Influences of Hypoxia Exercise on Whole-Body Insulin Sensitivity and Oxidative Metabolism in Older Individuals.,"CONTEXT


Aging is a primary risk factor for most chronic diseases, including type 2 diabetes. Both exercise and hypoxia regulate pathways that ameliorate age-associated metabolic muscle dysfunction.
OBJECTIVE


We hypothesized that the combination of hypoxia and exercise would be more effective in improving glucose metabolism than normoxia exercise.
DESIGN AND PARTICIPANTS


We randomized 29 older sedentary individuals (62 ± 6 years; 14 women, 15 men) to bicycle exercise under normobaric hypoxia (fraction of inspired oxygen = 15%) or normoxia (fraction of inspired oxygen = 21%).
INTERVENTION


Participants trained thrice weekly for 30 to 40 minutes over 8 weeks at a heart rate corresponding to 60% to 70% of peak oxygen update.
MAIN OUTCOME MEASURES


Insulin sensitivity measured by hyperinsulinemic-euglycemic glucose clamp and muscle protein expression before and after hyperinsulinemic-euglycemic glucose clamp.
RESULTS


Heart rate and perceived exertion during training were similar between groups, with lower oxygen saturation when exercising under hypoxia (88.7 ± 1.5 vs 96.2 ± 1.2%, P < 0.01). Glucose infusion rate after 8 weeks increased in both the hypoxia (5.7 ± 1.1 to 6.7 ± 1.3 mg/min/kg; P < 0.01) and the normoxia group (6.2 ± 2.1 to 6.8 ± 2.1 mg/min/kg; P = 0.04), with a mean difference between groups of -0.44 mg/min/kg; 95% CI, -1.22 to 0.34; (P = 0.25). Markers of mitochondrial content and oxidative capacity in skeletal muscle were similar after training in both groups. Changes in Akt phosphorylation and glucose transporter 4 under fasting and insulin-stimulated conditions were not different between groups over time.
CONCLUSIONS


Eight weeks of hypoxia endurance training led to similar changes in insulin sensitivity and markers of oxidative metabolism compared with normoxia training. Normobaric hypoxia exercise did not enhance metabolic effects in sedentary older women and men beyond exercise alone.",2019,"Changes in Akt (Ser473) phosphorylation and GLUT4 under fasting and insulin-stimulated conditions were not different between groups over time.
","['Older Individuals', 'sedentary older women and men beyond exercise alone', '29 older sedentary individuals (62±6 years, 14 women, 15 men) to']","['Normobaric hypoxia exercise', 'Hypoxia Exercise', 'hypoxia and exercise', 'bicycle exercise under normobaric hypoxia (FIO2=15%) or normoxia (FIO2=21', 'hypoxia endurance training']","['Glucose infusion rate', 'Heart rate and perceived exertion', 'insulin sensitivity and markers of oxidative metabolism', 'metabolic effects', 'Insulin sensitivity measured by hyperinsulinemic-euglycemic glucose clamp (HEGC), and muscle protein expression before and after HEGC', 'hypoxia', 'Changes in Akt (Ser473) phosphorylation and GLUT4 under fasting and insulin-stimulated conditions', 'Whole Body Insulin Sensitivity and Oxidative Metabolism']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015159', 'cui_str': 'Glucose Clamping'}, {'cui': 'C0026832', 'cui_str': 'Muscle Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}]",29.0,0.0958138,"Changes in Akt (Ser473) phosphorylation and GLUT4 under fasting and insulin-stimulated conditions were not different between groups over time.
","[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Chobanyan-Jürgens', 'Affiliation': 'Institute of Clinical Pharmacology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Renate J', 'Initials': 'RJ', 'LastName': 'Scheibe', 'Affiliation': 'Institute of Cell Biochemistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Arne B', 'Initials': 'AB', 'LastName': 'Potthast', 'Affiliation': 'Department of Pediatrics, Pediatric Metabolic Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Institute of Biometry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Freund', 'Affiliation': 'Institute of Cell Biochemistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Anibh M', 'Initials': 'AM', 'LastName': 'Das', 'Affiliation': 'Department of Pediatrics, Pediatric Metabolic Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Engeli', 'Affiliation': 'Institute of Clinical Pharmacology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Institute of Clinical Pharmacology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Haufe', 'Affiliation': 'Institute of Clinical Pharmacology, Hannover Medical School, Hannover, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00411']
1632,30314913,Immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccine versus two doses of nonavalent vaccine - A randomized clinical trial.,"BACKGROUND


Limited data is available on the use of different HPV vaccines in the same subjects. We evaluated the immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent (9vHPV) and one dose of bivalent vaccine (2vHPV) administered in different order versus two doses of 9vHPV vaccine.
METHODS


371 girls and boys aged 9-10 years were randomized (1:1) to receive (I) two doses of 9vHPV or (II) a mixed schedule of 2vHPV + 9vHPV or 9vHPV + 2vHPV with a 6 month interval. Antibodies to HPV were tested by ELISA in blood samples collected one or six months post-first dose and one month post-second dose.
RESULTS


Post-first dose of 9vHPV 99.4-100% of subjects were seropositive to 9 HPV types included in the vaccine. GMTs varied from 5.0 to 73.6 IU(AU)/ml depending on HPV type. Post-first dose of 2vHPV all subjects were seropositive to HPV16 and 18 (GMTs 16.7 and 11.7 IU/ml, respectively) and 50.0-76.7% were seropositive to 7 types not included in 2vHPV (GMTs varied from 0.3 to 17.5 AU/ml depending on type). Post-second dose all subjects, regardless of the study group, were seropositive to 9 HPV types included in 9vHPV. Anti-HPV16 and 18 GMTs were higher in subjects with the mixed schedule and for the other 7 HPV types higher in subjects who received two doses of 9vHPV vaccine. A higher proportion of subjects who received 2vHPV reported local or systemic adverse events than those who received 9vHPV as the first dose. Post-second dose there were no differences in reported adverse events between the two vaccines.
CONCLUSIONS


The results show the mixed HPV vaccination schedules used in this study are immunogenic and have an acceptable safety profile. Although the seroprotective threshold of antibodies remains unknown the 100% seropositivity to all 9 HPV types included in 9vHPV and the increase of GMTs observed in all study groups post-second dose administration are reassuring and suggest protection might be achieved regardless of the schedule used.
CLINICAL TRIALS REGISTRATION


Clinicaltrials.gov NCT02567955.",2018,A higher proportion of subjects who received 2vHPV reported local or systemic adverse events than those who received 9vHPV as the first dose.,['371 girls and boys aged 9-10\u202fyears'],"['bivalent vaccine (2vHPV', '9vHPV vaccine', '9vHPV', 'bivalent HPV vaccine', 'mixed vaccination schedule with one dose of nonavalent (9vHPV', '9vHPV or (II) a mixed schedule of 2vHPV\u202f+\u202f9vHPV or 9vHPV\u202f+\u202f2vHPV with a 6\u202fmonth interval']","['local or systemic adverse events', 'immunogenicity and safety', 'adverse events', 'Immunogenicity and safety']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",371.0,0.175899,A higher proportion of subjects who received 2vHPV reported local or systemic adverse events than those who received 9vHPV as the first dose.,"[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Gilca', 'Affiliation': 'Quebec Public Health Institute, Quebec, Canada; Laval University Research Hospital Center, Quebec, Canada. Electronic address: vladimir.gilca@inspq.qc.ca.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Sauvageau', 'Affiliation': 'Quebec Public Health Institute, Quebec, Canada; Laval University Research Hospital Center, Quebec, Canada.'}, {'ForeName': 'Gitika', 'Initials': 'G', 'LastName': 'Panicker', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'De Serres', 'Affiliation': 'Quebec Public Health Institute, Quebec, Canada; Laval University Research Hospital Center, Quebec, Canada.'}, {'ForeName': 'Manale', 'Initials': 'M', 'LastName': 'Ouakki', 'Affiliation': 'Quebec Public Health Institute, Quebec, Canada.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Unger', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, USA.'}]",Vaccine,['10.1016/j.vaccine.2018.09.057']
1633,30944936,What is the optimal length for single-incision tape?,"INTRODUCTION AND HYPOTHESIS


The aim of this study was to assess the length of adjustable single-incision midurethral tape (SIMS; Ajust), which is needed to fix this tape to the obturator membrane. From these data, we can deduce the optimal length of the SIMS.
METHODS


For this study, we employed the intra-operative data of patients included in a single-center randomized trial comparing the efficacy of Tension free vaginal tape obturator (TVT-O) and Ajust. The length of the Ajust tape was calculated using the formula: total length of the tape minus the length of the stylet used for the tape lock, minus the length of the lock minus the width of the two anchors. The length of the obturator tape was calculated using the formula: total tape length minus the snipped parts of the tape. The correlation coefficient of the tape length to basic biometric parameters, such as height, weight, and body mass index, was calculated.
RESULTS


For this study, data from 50 women from each group, TVT-O and Ajust, were used. The mean length of the Ajust tape inside the body is 11.6 cm (SD 0.9), with a minimum length of 9.6 cm and a maximum length of 14.6 cm. The mean length of TVT-O tape inside the body is 20.3 cm (SD 2.1), with a minimum of 14.8 cm and a maximum length of 24.5 cm.
CONCLUSIONS


This study demonstrates that to achieve continence it is necessary to use different lengths of single-incision tape. Inappropriate SIMS length could cause failure related to the tape itself and not to the TVT technique.",2019,"The correlation coefficient of the tape length to basic biometric parameters, such as height, weight, and body mass index, was calculated.
","['50 women from each group, TVT-O and Ajust, were used']",['Tension free vaginal tape obturator (TVT-O) and Ajust'],"['height, weight, and body mass index', 'mean length of TVT-O tape inside the body', 'mean length of the Ajust tape inside the body', 'length of the obturator tape', 'length of the Ajust tape']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1721083', 'cui_str': 'Tension-Free Vaginal Tape'}, {'cui': 'C0182021', 'cui_str': 'Obturator (physical object)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0182021', 'cui_str': 'Obturator (physical object)'}]",50.0,0.0207539,"The correlation coefficient of the tape length to basic biometric parameters, such as height, weight, and body mass index, was calculated.
","[{'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Svabik', 'Affiliation': 'Department of Obstetrics and Gynecology, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Jaromir', 'Initials': 'J', 'LastName': 'Masata', 'Affiliation': 'Department of Obstetrics and Gynecology, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic. masata@volny.cz.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Zvara', 'Affiliation': 'Charles University in Prague, Faculty of Sciences, Prague, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Hubka', 'Affiliation': 'Department of Obstetrics and Gynecology, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Alois', 'Initials': 'A', 'LastName': 'Martan', 'Affiliation': 'Department of Obstetrics and Gynecology, 1st Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}]",International urogynecology journal,['10.1007/s00192-019-03926-9']
1634,30656637,FentAnyl or placebo with KeTamine for emergency department rapid sequence intubation: The FAKT study protocol.,"BACKGROUND


Some critically ill patients require rapid sequence intubation in the emergency department, and ketamine is one sedative agent employed, due to its relative haemodynamic stability. Tachycardia and hypertension are frequent side effects, and in less stable patients, shock can be unmasked or exacerbated. The use of fentanyl as a co-induction agent may lead to a smoother haemodynamic profile post-induction, which may lead to reduced mortality in this critically ill cohort. This randomised controlled trial aims to compare the effect of administering fentanyl vs placebo in a standardised induction regimen with ketamine and rocuronium on (a) the percentage of patients in each group with a systolic blood pressure outside the range of 100-150 mm Hg within 10 minutes of induction, (b) the laryngoscopic view, and (c) 30-day mortality.
METHODS/DESIGN


Three hundred patients requiring rapid sequence intubation in participating emergency departments will be randomised to receive either fentanyl or placebo (0.9% saline) in addition to ketamine and rocuronium according to a standardised, weight-based induction regimen. The primary outcome measure is the percentage of patients in each group with a systolic blood pressure outside the range of 100-150 mm Hg within 10 minutes of induction. Secondary outcome measures include the laryngoscopic view, percentage of first pass success, 30-day mortality and number of ventilator-free days at 30 days.
DISCUSSION


The effect of adding fentanyl to an induction regimen of ketamine and rocuronium will be evaluated, both in terms of post-intubation physiology, the effect on intubating conditions, and 30-day mortality.",2019,"The use of fentanyl as a co-induction agent may lead to a smoother haemodynamic profile post-induction, which may lead to reduced mortality in this critically ill cohort.","['patients in each group with a systolic blood pressure outside the range of 100-150\xa0mm', 'emergency department rapid sequence intubation', 'Three hundred patients requiring rapid sequence intubation in participating emergency departments']","['ketamine', 'fentanyl or placebo', 'fentanyl', 'ketamine and rocuronium', 'fentanyl vs placebo', 'FentAnyl or placebo with KeTamine']","['systolic blood pressure outside the range of 100-150\xa0mm', 'intubating conditions, and 30-day mortality', 'laryngoscopic view, percentage of first pass success, 30-day mortality and number of ventilator-free days at 30 days', 'Tachycardia and hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0444693', 'cui_str': 'First pass (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",300.0,0.602475,"The use of fentanyl as a co-induction agent may lead to a smoother haemodynamic profile post-induction, which may lead to reduced mortality in this critically ill cohort.","[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ferguson', 'Affiliation': 'Liverpool Hospital, Liverpool BC, New South Wales, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Milligan', 'Affiliation': 'Royal North Shore Hospital, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Buttfield', 'Affiliation': 'Campbelltown Hospital, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Shamus', 'Initials': 'S', 'LastName': 'Shepherd', 'Affiliation': 'Orange Health Service, Orange, New South Wales, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Burns', 'Affiliation': 'The Northern Beaches Hospital, Frenchs Forest, New South Wales, Australia.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Reid', 'Affiliation': 'The Northern Beaches Hospital, Frenchs Forest, New South Wales, Australia.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Aneman', 'Affiliation': 'Liverpool Hospital, Liverpool BC, New South Wales, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Harris', 'Affiliation': 'Liverpool Hospital, Liverpool BC, New South Wales, Australia.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13309']
1635,30938299,"Maternal pertussis vaccination and its effects on the immune response of infants aged up to 12 months in the Netherlands: an open-label, parallel, randomised controlled trial.","BACKGROUND


Maternal tetanus, diphtheria, and acellular pertussis (Tdap) vaccination offers protection for neonates against clinical pertussis until primary vaccinations, but maternal antibodies also interfere with infants' immune responses to primary vaccinations. We investigated the effect of maternal Tdap vaccination on the pertussis antibody responses of infants starting primary vaccinations at age 3 months.
METHODS


In an open-label, parallel, randomised, controlled trial, pregnant women aged 18-40 years with a low risk of pregnancy complications were recruited through independent midwives at 36 midwife clinics in the Netherlands and received Tdap vaccination either at 30-32 weeks of pregnancy (maternal Tdap group) or within 48 h after delivery (control group). All term-born infants were vaccinated with the diphtheria, tetanus, and pertussis-inactivated poliomyelitis-Haemophilus influenzae type B-hepatitis B six-in-one vaccine and a ten-valent pneumococcal vaccine at 3 months, 5 months, and 11 months. Randomisation was done using a number generator in a 1:1 ratio and with sealed envelopes. Participants and clinical trial staff were not masked, but laboratory technicians were unaware of study group assignments. The primary endpoint was serum IgG pertussis toxin antibody concentrations at age 3 months. Cord blood and infant blood samples were collected at age 2 months, 3 months, 6 months, 11 months, and 12 months. Analysis was done by modified intention to treat with all randomly assigned participants in case a laboratory result was available. This trial is registered with ClinicaltTrialsRegister.eu (EudraCT 2012-004006-9) and trialregister.nl (NTR number NTR4314). The trial is now closed to new participants.
FINDINGS


Between Jan 16, 2014, and March 4, 2016, 118 pregnant women were enrolled into our study, with 58 in the maternal Tdap group and 60 in the control group. The geometric mean concentration (GMC) of pertussis toxin antibodies were higher in infants in the maternal Tdap group than in the control group infants at age 3 months (GMC ratio 16·6, 95% CI 10·9-25·2) and also significantly higher compared with control infants at age 2 months. After primary vaccinations, antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin were significantly lower at all timepoints in infants of the maternal Tdap group than in infants in the control group. No safety issues after maternal Tdap vaccination were encountered.
INTERPRETATION


In view of the high pertussis toxin antibody concentrations at age 3 months, maternal vaccination supports a delay of the first pertussis vaccination in infants until at least age 3 months. Maternal antibody interference affects antibody concentrations after primary and booster vaccinations. The clinical consequences of this interference remain to be established.
FUNDING


The Dutch Ministry of Health, Welfare, and Sport.",2019,"After primary vaccinations, antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin were significantly lower at all timepoints in infants of the maternal Tdap group than in infants in the control group.","['118 pregnant women were enrolled into our study, with 58 in the maternal Tdap group and 60 in the control group', 'infants starting primary vaccinations at age 3 months', 'pregnant women aged 18-40 years with a low risk of pregnancy complications were recruited through independent midwives at 36 midwife clinics in the Netherlands and received', 'infants aged up to 12 months in the Netherlands', 'Between Jan 16, 2014, and March 4, 2016']","['maternal Tdap vaccination', 'diphtheria, and acellular pertussis (Tdap) vaccination', 'Tdap vaccination either at 30-32 weeks of pregnancy (maternal Tdap group) or within 48 h after delivery (control group', 'diphtheria, tetanus, and pertussis-inactivated poliomyelitis-Haemophilus influenzae type B-hepatitis B six-in-one vaccine and a ten-valent pneumococcal vaccine']","['Maternal antibody interference affects antibody concentrations', 'antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin', 'serum IgG pertussis toxin antibody concentrations', 'geometric mean concentration (GMC) of pertussis toxin antibodies', 'Cord blood and infant blood samples']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0032962', 'cui_str': 'Pregnancy Complications'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0042203', 'cui_str': 'Pertussis vaccination (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine (substance)'}]","[{'cui': 'C0729663', 'cui_str': 'Maternal antibody (substance)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0020731', 'cui_str': 'Histamine-Sensitizing Factor'}, {'cui': 'C0136166', 'cui_str': 'pertactin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",118.0,0.177939,"After primary vaccinations, antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin were significantly lower at all timepoints in infants of the maternal Tdap group than in infants in the control group.","[{'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Barug', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Pronk', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Marlies A', 'Initials': 'MA', 'LastName': 'van Houten', 'Affiliation': 'Department of Paediatrics, Spaarne Hospital, Hoofddorp, Netherlands.'}, {'ForeName': 'Florens G A', 'Initials': 'FGA', 'LastName': 'Versteegh', 'Affiliation': ""University Groningen, University Medical Centre Groningen/Beatrix Children's Hospital, Groningen, Netherlands.""}, {'ForeName': 'Mirjam J', 'Initials': 'MJ', 'LastName': 'Knol', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van de Kassteele', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Guy A M', 'Initials': 'GAM', 'LastName': 'Berbers', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Elisabeth A M', 'Initials': 'EAM', 'LastName': 'Sanders', 'Affiliation': ""Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands; Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, Utrecht, Netherlands.""}, {'ForeName': 'Nynke Y', 'Initials': 'NY', 'LastName': 'Rots', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands. Electronic address: nynke.rots@rivm.nl.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30717-5']
1636,30946495,A Problem-Solving Intervention for Hospice Family Caregivers: A Randomized Clinical Trial.,"OBJECTIVES


Family caregivers of hospice patients have multiple needs as they try to cope during a stressful time. Translatable interventions effective in improving caregiver outcomes are greatly needed. Our objective was to assess the impact of a problem-solving intervention (called Problem-Solving Intervention to Support Caregivers in End-of-Life Care Settings [PISCES]) to support hospice caregivers on caregiver quality of life and anxiety, and compare its effectiveness delivered face to face and via videoconferencing.
DESIGN


In this 4-year randomized clinical trial, caregivers were randomly assigned to a group receiving standard care with added ""friendly calls"" (attention control [AC] group), a group receiving standard care and PISCES delivered face to face (F2F), or a group receiving standard care and PISCES delivered via videoconferencing (VC).
SETTING


Home hospice.
PARTICIPANTS


A total of 514 caregivers participated (172 in AC, 171 in F2F, and 171 in VC). Caregivers were predominantly female (75%); mean age was 60.3 years.
INTERVENTION


PISCES includes a structured curriculum delivered in three sessions and motivates caregivers to adopt a positive attitude, define problems by obtaining facts, set goals, and generate and evaluate solutions.
MEASUREMENTS


Quality of life was measured by the Caregiver Quality of Life Index-Revised; anxiety was measured by the Generalized Anxiety Disorder 7-Item. Other measures included the Caregiver Reaction Assessment scale, demographic data, and an exit interview.
RESULTS


Compared with AC, caregivers in the F2F condition had postintervention reduced anxiety (-1.31 [95% confidence interval [CI] = -2.11 to .50]; p = .004) and improved social (.57 [95% CI = .19-.95]; p = .01), financial (.57 [95% CI = .21-.93]; p = .004), and physical quality of life (.53 [95% CI = .19-.87]; p = .01). There were no differences in caregivers in the VC condition compared with the AC condition.
CONCLUSION


The PISCES intervention improves caregiver outcomes and is effective when delivered in person. How to integrate technology to reduce the intervention delivery cost warrants further investigation.",2019,"Compared with AC, caregivers in the F2F condition had postintervention reduced anxiety (","['Family caregivers of hospice patients', 'A total of 514 caregivers participated (172 in AC, 171 in F2F, and 171 in VC', 'Home hospice', 'Hospice Family Caregivers', 'Caregivers were predominantly female (75%); mean age was 60.3 years']","['standard care with added ""friendly calls"" (attention control [AC] group), a group receiving standard care and PISCES delivered face to face (F2F), or a group receiving standard care and PISCES delivered via videoconferencing (VC', 'Problem-Solving Intervention', 'PISCES intervention', 'problem-solving intervention (called Problem-Solving Intervention']","['physical quality of life', 'Quality of life', 'caregiver outcomes', 'social', 'Caregiver Reaction Assessment scale, demographic data, and an exit interview', 'Caregiver Quality of Life Index-Revised; anxiety']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",514.0,0.147061,"Compared with AC, caregivers in the F2F condition had postintervention reduced anxiety (","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demiris', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Debra Parker', 'Initials': 'DP', 'LastName': 'Oliver', 'Affiliation': 'School of Medicine, University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Washington', 'Affiliation': 'School of Medicine, University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Pike', 'Affiliation': 'School of Nursing, University of Washington, Seattle, Washington.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15894']
1637,31545155,Torque gains and neural adaptations following low-intensity motor nerve electrical stimulation training.,"The purpose of the study was to assess neural adaptations of the plantar-flexors induced by an electrical stimulation training applied over the motor nerve at low intensity using two different stimulation frequencies. Thirty subjects were randomly assigned into 3 groups: 20 Hz, 100 Hz, and control group. The training consisted of 15 sessions of 25 stimulation trains applied over the tibial nerve and delivered at an intensity evoking 10% maximal voluntary isometric contraction (MVIC). Before and after training, MVIC was assessed and neural adaptations were evaluated by the voluntary activation level (VAL) and the V-wave (normalized by the superimposed muscle compound action potential, V/M SUP ). H-reflex and motor-evoked potential (MEP) recorded during MVIC were studied to assess spinal and corticospinal excitabilities [i.e., maximal H-reflex during maximal voluntary isometric contraction (H SUP )/M SUP  and maximal motor-evoked potential during maximal voluntary isometric contraction (MEP SUP )/M SUP ]. MVIC significantly increased after training only for the two training groups ( P  = 0.017). This increase was accompanied by a significant increase of VAL only for these groups ( P  = 0.014), whereas statistical analysis revealed a time effect for V/M SUP  ( P  = 0.022). H SUP /M SUP  and MEP SUP /M SUP  were significantly increased at post conditions only for the 100 Hz group ( P  = 0.021 and  P  = 0.029). Results show that low-intensity electrical stimulation training applied over the motor nerve can induce torque gains, accompanied by neural adaptations. Stimulation frequency differentially affected spinal and corticospinal excitabilities, indicating that neural adaptations could have a supraspinal origin for the 20-Hz protocol, whereas spinal and supraspinal mechanisms were implicated in the torque increases after the 100-Hz training. NEW & NOTEWORTHY  This study brings new insights into the neurophysiological mechanisms responsible for torque gains after electrical stimulation training using wide pulse duration and low stimulation intensity applied over the motor nerve. Stimulation frequency had a distinct impact on spinal and/or supraspinal origins of the observed neural adaptations. The use of the aforementioned stimulation parameters in rehabilitation settings can be proved beneficial in terms of strength gains while avoiding any serious discomfort because of stimulation.",2019,SUP  were significantly increased at post conditions only for the 100 Hz group (P=0.021 and P=0.029).,['Thirty subjects'],"['H SUP /M', '25 stimulation trains applied over the tibial nerve and delivered at an intensity evoking 10% Maximal Voluntary Isometric Contraction (MVIC', 'low intensity motor nerve electrical stimulation training', 'low intensity electrical stimulation training', 'electrical stimulation training']","['torque gains', 'SUP', 'VAL', 'voluntary activation level (VAL) and the V-wave', 'Torque gains and neural adaptations', 'MVIC', 'H reflex and Motor Evoked Potential (MEP', 'SUP  and MEP SUP']","[{'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1529218', 'cui_str': 'Vals'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4301968', 'cui_str': 'v wave (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0018447', 'cui_str': 'H-Reflex'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}]",30.0,0.0194353,SUP  were significantly increased at post conditions only for the 100 Hz group (P=0.021 and P=0.029).,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Vitry', 'Affiliation': 'INSERM UMR1093-CAPS, Université Bourgogne Franche-Comté, UFR des Sciences du Sport, F-21000, Dijon, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'INSERM UMR1093-CAPS, Université Bourgogne Franche-Comté, UFR des Sciences du Sport, F-21000, Dijon, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Papaiordanidou', 'Affiliation': 'INSERM UMR1093-CAPS, Université Bourgogne Franche-Comté, UFR des Sciences du Sport, F-21000, Dijon, France.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00513.2019']
1638,30940423,Eating Pleasure in a Sample of Obese Brazilian Women: A Qualitative Report of an Interdisciplinary Intervention Based on the Health at Every Size Approach.,"INTRODUCTION


Health at Every Size (HAES) is a weight-neutral approach focused on promoting healthy behaviors in people with different body sizes and on enhancing pleasure derived from consuming food to achieve sustainable healthy eating outcomes. However, to the best of our knowledge, there are no studies in the literature assessing the effects of the HAES approach on perceptions of eating pleasure.
OBJECTIVE


We qualitatively investigated the perceptions of obese women about eating pleasure before and after a new interdisciplinary, nonprescriptive intervention based on the HAES approach.
DESIGN


The intervention was a randomized controlled clinical trial, designated as Health and Wellness in Obesity, conducted over 7 months at University of São Paulo (Brazil). We used a qualitative approach to data construction and analysis of perceptions about eating pleasure. Participants were randomized to either the intervention (I-HAES) group or the control (CTRL) group. The I-HAES group featured individual nutritional counseling, group practice of enjoyable physical activity, and philosophical workshops. The CTRL group was a traditional HAES intervention group (lecture-based model). Focus group discussions eliciting perceptions of pleasure around eating were conducted at baseline and post-study. Focus group transcripts were analyzed by exploratory content analysis.
PARTICIPANTS


Forty-three women aged 25 to 50 years with body mass index (measured in kilograms per square meter) between 30 and 39. 9 completed the intervention and the focus groups, with 32 in the I-HAES group and 11 in the CTRL group.
RESULTS


Lack of guilt about experiencing pleasure while eating and increased reflection on their own desires increased in participants of both groups after the study. The I-HAES group also displayed a greater sense of autonomy related to eating, increased pleasure in commensality, familiarity with the practice of cooking, and decreased automatic eating.
CONCLUSION


HAES-based intervention featuring nutritional counseling, appreciation for physical activity, and philosophical engagement was shown to stimulate pleasure around eating without leading to indiscriminate eating.",2019,"RESULTS


Lack of guilt about experiencing pleasure while eating and increased reflection on their own desires increased in participants of both groups after the study.","['Forty-three women aged 25 to 50 years with body mass index (measured in kilograms per square meter) between 30 and 39', 'obese women about eating pleasure before and after a new interdisciplinary, nonprescriptive intervention based on the HAES approach', 'Obese Brazilian Women']","['HAES approach', 'individual nutritional counseling, group practice of enjoyable physical activity, and philosophical workshops', 'intervention (I-HAES) group or the control (CTRL', 'Interdisciplinary Intervention', 'traditional HAES intervention', 'CTRL']","['sense of autonomy related to eating, increased pleasure in commensality, familiarity with the practice of cooking, and decreased automatic eating', 'Eating Pleasure']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0457242', 'cui_str': 'square metres'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}]",43.0,0.0456352,"RESULTS


Lack of guilt about experiencing pleasure while eating and increased reflection on their own desires increased in participants of both groups after the study.","[{'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Sabatini', 'Affiliation': ''}, {'ForeName': 'Mariana D', 'Initials': 'MD', 'LastName': 'Ulian', 'Affiliation': ''}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Perez', 'Affiliation': ''}, {'ForeName': 'Ana Jéssica', 'Initials': 'AJ', 'LastName': 'Pinto', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Vessoni', 'Affiliation': ''}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Aburad', 'Affiliation': ''}, {'ForeName': 'Fabiana B', 'Initials': 'FB', 'LastName': 'Benatti', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lopes de Campos-Ferraz', 'Affiliation': ''}, {'ForeName': 'Desire', 'Initials': 'D', 'LastName': 'Coelho', 'Affiliation': ''}, {'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'de Morais Sato', 'Affiliation': ''}, {'ForeName': 'Odilon J', 'Initials': 'OJ', 'LastName': 'Roble', 'Affiliation': ''}, {'ForeName': 'Ramiro Fernandez', 'Initials': 'RF', 'LastName': 'Unsain', 'Affiliation': ''}, {'ForeName': 'Roseanne C', 'Initials': 'RC', 'LastName': 'Schuster', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': ''}, {'ForeName': 'Fernanda B', 'Initials': 'FB', 'LastName': 'Scagliusi', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.01.006']
1639,30920880,"Comparing Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Cancer: A Randomized, Multicenter, Phase III Clinical Trial.","PURPOSE


This trial aimed to assess the efficacy and safety of the paclitaxel plus fluorouracil regimen versus the cisplatin plus fluorouracil regimen in definitive concurrent chemoradiotherapy (dCRT) in patients with locally advanced esophageal squamous cell carcinoma (ESCC).
PATIENTS AND METHODS


Patients with locally advanced ESCC were enrolled and randomly assigned to either the paclitaxel plus fluorouracil group or the cisplatin plus fluorouracil group. The patients in the paclitaxel plus fluorouracil group were treated with paclitaxel and fluorouracil one cycle per week in dCRT for five cycles followed by paclitaxel and fluorouracil one cycle per month in consolidation chemotherapy for two cycles. The patients in the cisplatin/5-fluorouracil group were treated with cisplatin and fluorouracil one cycle per month in dCRT for two cycles followed by two cycles in consolidation chemotherapy. The radiotherapy dose was 61.2 Gy delivered in 34 fractions. The primary end point was 3-year overall survival (OS).
RESULTS


Four hundred thirty-six patients with ESCC in six centers were recruited at a 1:1 ratio between April 2012 and July 2015. The median follow-up of the surviving patients was 48.7 months (interquartile range, 42.6-60.9). The 3-year OS was 55.4% in the paclitaxel plus fluorouracil group and 51.8% in the cisplatin plus fluorouracil group (hazard ratio, 0.905 [95% CI, 0.698 to 1.172];  P  = .448). The 3-year progression-free survival was also not significantly different between the paclitaxel plus fluorouracil group and the cisplatin plus fluorouracil group (43.7%  v  45.5%, respectively; hazard ratio, 0.973 [95% CI, 0.762 to 1.243];  P  = .828). Compared with the cisplatin plus fluorouracil group, the paclitaxel plus fluorouracil group had significantly lower incidences of acute grade 3 or higher anemia, thrombocytopenia, anorexia, nausea, vomiting, and fatigue ( P  < .05), but higher incidences of acute grade 3 or higher leukopenia, radiation dermatitis, and radiation pneumonitis ( P  < .05).
CONCLUSION


The paclitaxel plus fluorouracil regimen did not significantly prolong the OS compared with the standard cisplatin plus fluorouracil regimen in dCRT in patients with locally advanced ESCC.",2019,"The 3-year progression-free survival was also not significantly different between the paclitaxel plus fluorouracil group and the cisplatin plus fluorouracil group (43.7%  v  45.5%, respectively; hazard ratio, 0.973","['Four hundred thirty-six patients with ESCC in six centers were recruited at a 1:1 ratio between April 2012 and July 2015', 'Locally Advanced Esophageal Squamous Cell Cancer', 'patients with locally advanced ESCC', 'patients with locally advanced esophageal squamous cell carcinoma (ESCC', 'Patients with locally advanced ESCC']","['paclitaxel plus fluorouracil', 'cisplatin/5-fluorouracil', 'chemoradiotherapy (dCRT', 'Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil', 'radiotherapy', 'standard cisplatin plus fluorouracil', 'cisplatin plus fluorouracil regimen', 'paclitaxel and fluorouracil', 'Chemoradiotherapy', 'cisplatin plus fluorouracil', 'cisplatin and fluorouracil']","['OS', '3-year OS', '3-year progression-free survival', '3-year overall survival (OS', 'efficacy and safety', 'acute grade 3 or higher anemia, thrombocytopenia, anorexia, nausea, vomiting, and fatigue', 'acute grade 3 or higher leukopenia, radiation dermatitis, and radiation pneumonitis']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0751688', 'cui_str': 'Squamous Cell Cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0279626', 'cui_str': 'Esophageal Squamous Cell Carcinoma'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0206063', 'cui_str': 'Pneumonia, Radiation'}]",436.0,0.0572158,"The 3-year progression-free survival was also not significantly different between the paclitaxel plus fluorouracil group and the cisplatin plus fluorouracil group (43.7%  v  45.5%, respectively; hazard ratio, 0.973","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jinjun', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': '2 Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Zhengfei', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Weixin', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jialiang', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': '3 Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Chaoyang', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ""4 Zhenjiang First People's Hospital, Zhenjiang, China.""}, {'ForeName': 'Huarong', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': ""4 Zhenjiang First People's Hospital, Zhenjiang, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': '5 The First Affiliated Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': '6 Fudan University Shanghai Cancer Center Minhang Branch Hospital, Shanghai, China.'}, {'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': '6 Fudan University Shanghai Cancer Center Minhang Branch Hospital, Shanghai, China.'}, {'ForeName': 'Jiancheng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': '7 Fujian Provincial Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Huixun', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Saiquan', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Kuaile', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02122']
1640,30697688,Diaphragm-sparing effect of the infraclavicular subomohyoid block vs low volume interscalene block. A randomized blinded study.,"BACKGROUND


Both low volume interscalene and infraclavicular-subomohyoid blocks were suggested to provide shoulder analgesia with low risk of phrenic nerve block. The aim of this study was to compare the frequency of the phrenic nerve block between these two techniques.
METHOD


Seventy-two patients scheduled for shoulder arthroscopy were included in this randomized controlled blind study. Before induction of general anesthesia, patients received low volume interscalene block using 5 mL of ropivacaine 0.5% (LVS group) or infraclavicular-subomohyoid block using 25 mL of ropivacaine 0.5% (ISO group). The diaphragmatic excursion was measured (using ultrasound) before the block and after surgery. If the ratio of postoperative to pre-block excursions was <25%, a phrenic nerve block was concluded. Secondary outcomes were: the duration of analgesia, the 24-hour morphine requirement, and patient satisfaction.
RESULTS


The phrenic nerve was blocked in 88.9% of patients in LVS group vs 5.6% in ISO group (P < 0.001). There was no significant difference between the two groups with regard to the duration of analgesia, the morphine consumption, and the patient satisfaction.
CONCLUSION


Compared with the low volume interscalene block, the infraclavicular subomohyoid block resulted in a significantly less frequent phrenic nerve block and with no difference in postoperative analgesia. Therefore, it may be relevant to consider for patients who cannot tolerate a phrenic nerve block.",2019,"There was no significant difference between the two groups with regard to the duration of analgesia, the morphine consumption, and the patient satisfaction.
","['patients who cannot tolerate a phrenic nerve block', 'Seventy-two patients scheduled for shoulder arthroscopy']","['low volume interscalene block using 5\xa0mL of ropivacaine 0.5% (LVS group) or infraclavicular-subomohyoid block using 25\xa0mL of ropivacaine', 'infraclavicular subomohyoid block vs low volume interscalene block', 'LVS']","['phrenic nerve', 'duration of analgesia, the morphine consumption, and the patient satisfaction', 'duration of analgesia, the 24-hour morphine requirement, and patient satisfaction', 'frequent phrenic nerve block', 'diaphragmatic excursion', 'postoperative analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0394695', 'cui_str': 'Injection of anesthetic agent into phrenic nerve (procedure)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0559702', 'cui_str': 'Arthroscopy of shoulder'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach (procedure)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0031774', 'cui_str': 'Phrenic Nerve'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0394695', 'cui_str': 'Injection of anesthetic agent into phrenic nerve (procedure)'}, {'cui': 'C0232086', 'cui_str': 'Diaphragmatic excursion (observable entity)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",72.0,0.158111,"There was no significant difference between the two groups with regard to the duration of analgesia, the morphine consumption, and the patient satisfaction.
","[{'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Taha', 'Affiliation': 'Department of Anesthesia, Healthpoint Hospital, Abu Dhabi, UAE.'}, {'ForeName': 'Nagib A', 'Initials': 'NA', 'LastName': 'Yurdi', 'Affiliation': 'Department of Orthopedic, Healthpoint Hospital, Abu Dhabi, UAE.'}, {'ForeName': 'Mohamed I', 'Initials': 'MI', 'LastName': 'Elahl', 'Affiliation': 'Department of Anesthesia, Healthpoint Hospital, Abu Dhabi, UAE.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abd-Elmaksoud', 'Affiliation': 'Anesthesia Department, Ain Shams University, Cairo, Egypt.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13322']
1641,30928207,Cerebellar repetitive transcranial magnetic stimulation for patients with essential tremor.,"INTRODUCTION


The possibility of repetitive transcranial magnetic stimulation (rTMS) as an alternative therapy for essential tremor (ET) patients has emerged. However, its effect on medicated ET patients is lacking. The aim of this pilot study was to investigate the effect of cerebellar low-frequency rTMS as an ""add-on"" treatment.
METHODS


In this single-blinded, randomized, sham-controlled pilot study, patients with ET were randomized into two groups, one receiving real-rTMS and the other sham-rTMS. For 5 days, 1200 stimulations per day were applied to the bilateral cerebellar hemispheres at an intensity of 90% of the resting motor threshold (RMT) with a frequency of 1-Hz. Motor evoked potentials (MEPs) and the Fahn-Tolosa-Marin tremor rating scales (TRS) were measured before, immediately, and 4 weeks after the completion of the rTMS procedures. All patients continued taking medications during all procedures.
RESULTS


Among 22 patients, 12 and 10 patients were randomized into the real- and sham-rTMS groups, respectively. Repeated analysis of variance (ANOVA) measurements showed that the total TRS, TRS-A and B were changed both in real and sham-rTMS groups without interaction between time and group. TRS-C and MEPs, were not significantly changed at each follow-up point in either the real or sham-rTMS sessions.
CONCLUSION


We conclude that cerebellar low-frequency rTMS is safe, but has no significant effect as an ""add-on"" therapy in patients with ET.",2019,"TRS-C and MEPs, were not significantly changed at each follow-up point in either the real or sham-rTMS sessions.
","['patients with essential tremor', '22 patients, 12 and 10 patients', 'patients with ET']","['real-rTMS and the other sham-rTMS', 'cerebellar low-frequency rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'real- and sham-rTMS', 'Cerebellar repetitive transcranial magnetic stimulation']","['total TRS, TRS-A and B', 'Motor evoked potentials (MEPs) and the Fahn-Tolosa-Marin tremor rating scales (TRS', 'TRS-C and MEPs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0270736', 'cui_str': 'Benign Essential Tremor'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0222045'}]",,0.0700831,"TRS-C and MEPs, were not significantly changed at each follow-up point in either the real or sham-rTMS sessions.
","[{'ForeName': 'Hae-Won', 'Initials': 'HW', 'LastName': 'Shin', 'Affiliation': 'Department of Neurology, Chung-Ang University College of Medicine, Seoul, South Korea; Human Motor Control Section, NINDS, National Institutes of Health, Bethesda, MD, USA. Electronic address: shinhw@cau.ac.kr.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hallett', 'Affiliation': 'Human Motor Control Section, NINDS, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Young H', 'Initials': 'YH', 'LastName': 'Sohn', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, South Korea.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2019.03.019']
1642,30923094,Bortezomib-based induction followed by stem cell transplantation in light chain amyloidosis: results of the multicenter HOVON 104 trial.,"This prospective, multicenter, phase II study investigated the use of four cycles of bortezomib-dexamethasone induction treatment, followed by high-dose melphalan and autologous stem cell transplantation (SCT) in patients with newly diagnosed light chain amyloidosis. The aim of the study was to improve the hematologic complete remission (CR) rate 6 months after SCT from 30% to 50%. Fifty patients were enrolled and 72% had two or more organs involved. The overall hematologic response rate after induction treatment was 80% including 20% CR and 38% very good partial remissions (VGPR). Fifteen patients did not proceed to SCT for various reasons but mostly treatment-related toxicity and disease-related organ damage and death (2 patients). Thirty-one patients received melphalan 200 mg/m 2  and four patients a reduced dose because of renal function impairment. There were no deaths related to the transplantation procedure. Hematologic responses improved at 6 months after SCT to 86% with 46% CR and 26% VGPR. However, due to the high treatment discontinuation rate before transplantation the primary endpoint of the study was not met and the CR rate in the intention-to-treat analysis was 32%. Organ responses continued to improve after SCT. We confirm the high efficacy of bortezomib-dexamethasone treatment in patients with AL amyloidosis. However, because of both treatment-related toxicity and disease characteristics, 30% of the patients could not proceed to SCT after induction treatment. ( Trial registered at Dutch Trial Register identifier NTR3220 ).",2019,Fifteen patients did not proceed to SCT for various reasons but mostly treatment-related toxicity and disease-related organ damage and death (2 patients).,"['Fifty patients were enrolled and 72% had two or more organs involved', 'patients with AL amyloidosis', 'light chain amyloidosis', 'patients with newly diagnosed light chain amyloidosis']","['bortezomib-dexamethasone', 'Bortezomib-based induction followed by stem cell transplantation', 'melphalan', 'melphalan and autologous stem cell transplantation (SCT']","['overall hematologic response rate', 'renal function impairment', 'toxicity and disease-related organ damage and death', 'hematologic complete remission (CR) rate', 'CR rate', 'Hematologic responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0268381', 'cui_str': 'AL Amyloidosis'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",50.0,0.0357223,Fifteen patients did not proceed to SCT for various reasons but mostly treatment-related toxicity and disease-related organ damage and death (2 patients).,"[{'ForeName': 'Monique C', 'Initials': 'MC', 'LastName': 'Minnema', 'Affiliation': 'Department of Hematology, UMC Utrecht Cancer Center, Utrecht, the Netherlands m.c.minnema@umcutrecht.nl.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Nasserinejad', 'Affiliation': 'HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Bouke', 'Initials': 'B', 'LastName': 'Hazenberg', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University of Groningen Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Hegenbart', 'Affiliation': 'Department of Hematology, Oncology and Rheumatology, Heidelberg University, Amyloidosis Center, Heidelberg, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Vlummens', 'Affiliation': 'Department of Haematology, Ghent University, Gent, Belgium.'}, {'ForeName': 'Paula F', 'Initials': 'PF', 'LastName': 'Ypma', 'Affiliation': 'Department of Hematology, HagaZiekenhuis, Den Haag, the Netherlands.'}, {'ForeName': 'Nicolaus', 'Initials': 'N', 'LastName': 'Kröger', 'Affiliation': 'Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ka Lung', 'Initials': 'KL', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, ZNA Stuivenberg, Antwerp, Belgium.'}, {'ForeName': 'Marie Jose', 'Initials': 'MJ', 'LastName': 'Kersten', 'Affiliation': 'Department of Hematology, Academic Medical Center, Lymphoma and Myeloma Center, Amsterdam, the Netherlands.'}, {'ForeName': 'M Ron', 'Initials': 'MR', 'LastName': 'Schaafsma', 'Affiliation': 'Department of Hematology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Croockewit', 'Affiliation': 'Department of Hematology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'de Waal', 'Affiliation': 'Department of Hematology, University of Groningen, Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Department of Hematology, VU University Medical Center, Amsterdam Cancer Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Lidwien', 'Initials': 'L', 'LastName': 'Tick', 'Affiliation': 'Department of Internal Medicine, Maxima Medisch Centrum, Eindhoven, the Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Broijl', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Koene', 'Affiliation': 'Department of Hematology, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bos', 'Affiliation': 'Department of Hematology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schönland', 'Affiliation': 'Department of Hematology, Oncology and Rheumatology, Heidelberg University, Amyloidosis Center, Heidelberg, Germany.'}]",Haematologica,['10.3324/haematol.2018.213900']
1643,31418022,"Immunogenicity and Safety of 3 Formulations of a Respiratory Syncytial Virus Candidate Vaccine in Nonpregnant Women: A Phase 2, Randomized Trial.","BACKGROUND


Respiratory syncytial virus (RSV) is a common cause of respiratory tract illness and hospitalization in neonates and infants. RSV vaccination during pregnancy may protect offspring in their first months of life.
METHODS


This randomized, observer-blind, multicenter, phase 2 study evaluated the immunogenicity and safety of an RSV candidate vaccine in healthy nonpregnant women aged 18-45 years. Four hundred participants were randomized (1:1:1:1) to receive a single intramuscular dose of vaccine containing 30 µg, 60 µg, or 120 µg of RSV fusion protein engineered to preferentially maintain a prefusion conformation (RSV-PreF vaccine) or placebo.
RESULTS


Thirty days postvaccination, RSV-A neutralizing antibody geometric mean titers (GMTs) increased 3.75-, 4.42- and 4.36-fold; RSV-B neutralizing antibody GMTs 2.36-, 2.54- and 2.76-fold; and palivizumab competing antibody (PCA) concentrations 11.69-, 14.38- and 14.24-fold compared with baseline levels in the 30 µg, 60 µg, and 120 µg RSV-PreF groups, respectively. Antibody titers and PCA concentrations at day 30 were significantly higher with the 120 µg compared to the 30 µg RSV-PreF vaccine. All RSV-PreF vaccine formulations and the placebo had similar reactogenicity profiles. No serious adverse events were considered to be related to the RSV-PreF vaccine.
CONCLUSIONS


The 3 formulations of the investigational RSV-PreF vaccine were well-tolerated and induced RSV-A and RSV-B neutralizing antibodies and PCAs in healthy, nonpregnant women.
CLINICAL TRIALS REGISTRATION


NCT02956837.",2019,"Thirty days post-vaccination, RSV-A neutralizing antibody geometric mean titers (GMTs) increased 3.75, 4.42 and 4.36fold; RSV-B neutralizing antibody GMTs 2.36, 2.54 and 2.76fold; and palivizumab competing antibody (PCA) concentrations 11.69, 14.38 and 14.24fold compared to baseline levels in the 30µg, 60µg and 120µg RSV-PreF groups, respectively.","['Four hundred participants', 'neonates and infants', 'non-pregnant women', 'healthy non-pregnant 18-45-year-old women', 'healthy, non-pregnant women']","['placebo', 'respiratory syncytial virus candidate vaccine', 'vaccine containing 30µg, 60µg, or 120µg of RSV-F protein engineered to preferentially maintain a pre-fusion conformation (RSV-PreF vaccine) or placebo', 'RSV candidate vaccine', 'RSV vaccination']","['tolerated and induced RSV-A and RSV-B neutralizing antibodies and PCAs', 'reactogenicity profiles', 'Immunogenicity and safety', 'Antibody titers and PCA concentrations', 'immunogenicity and safety']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0878517', 'cui_str': 'Engineer'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",400.0,0.370908,"Thirty days post-vaccination, RSV-A neutralizing antibody geometric mean titers (GMTs) increased 3.75, 4.42 and 4.36fold; RSV-B neutralizing antibody GMTs 2.36, 2.54 and 2.76fold; and palivizumab competing antibody (PCA) concentrations 11.69, 14.38 and 14.24fold compared to baseline levels in the 30µg, 60µg and 120µg RSV-PreF groups, respectively.","[{'ForeName': 'Tino F', 'Initials': 'TF', 'LastName': 'Schwarz', 'Affiliation': 'Institute of Laboratory Medicine and Vaccination Centre, Klinikum Würzburg Mitte, Würzburg, Germany.'}, {'ForeName': 'Roderick A', 'Initials': 'RA', 'LastName': 'McPhee', 'Affiliation': 'GlaxoSmithKline (GSK), Rockville, Maryland.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Launay', 'Affiliation': 'Université de Paris, Inserm, clinical investigation center 1417, Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Leroux-Roels', 'Affiliation': 'Center for Vaccinology, Ghent University and University Hospital, Belgium.'}, {'ForeName': 'Jaak', 'Initials': 'J', 'LastName': 'Talli', 'Affiliation': 'Ravi-ja Uuringukeskus Innomedica OÜ, Tallinn, Estonia.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Picciolato', 'Affiliation': 'GSK, Rixensart.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'GlaxoSmithKline (GSK), Rockville, Maryland.'}, {'ForeName': 'Rongman', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': 'GlaxoSmithKline (GSK), Rockville, Maryland.'}, {'ForeName': 'Thi Lien-Anh', 'Initials': 'TL', 'LastName': 'Nguyen', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Dieussaert', 'Affiliation': 'GlaxoSmithKline (GSK), Rockville, Maryland.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'GlaxoSmithKline (GSK), Rockville, Maryland.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Schmidt', 'Affiliation': 'GlaxoSmithKline (GSK), Rockville, Maryland.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz395']
1644,31821654,Randomised clinical trial of group-based physiotherapy in extremely low birthweight children with minimal/mild motor impairment: A preliminary study.,"AIM


Extremely low birthweight infants often present with mild neurodevelopmental impairments in gross motor function and postural stability in early childhood. The aim of the study was to undertake a randomised controlled trial to determine the short- and longer-term effects of group-based physiotherapy compared to standard care on performance in extremely low birthweight children with minimal/mild impairment.
METHODS


Fifty children aged 4 years, born <28 weeks gestation and/or birthweight <1000 g with minimal/mild motor impairment were enrolled in a randomised controlled trial and randomly allocated to 6 weeks of group-based intervention (n = 24) or standard care (n = 26). The intervention consisted of a combination of traditional physiotherapy and task-oriented approaches of approximately 1 h in duration and varied according to each child's strengths and weaknesses. Baseline, post intervention and 1 year post baseline assessments included Movement Assessment Battery for Children-2 (MABC-2), single leg stance, lateral reach and long jump.
RESULTS


Forty-eight (96%) children completed the study, which demonstrated no significant differences between the intervention and standard care groups on any of the assessments. Both groups improved initially from baseline to initial reassessment on the MABC-2 (P < 0.001). For both groups, however, MABC-2 manual dexterity, aiming/catching and total score declined from baseline to 1 year follow-up. However, for both groups, single leg stance and limb strength were significantly improved from baseline to 1 year follow-up.
CONCLUSIONS


There were no differences in outcomes between groups. Both approaches may contribute to improved short-term performance and longer-term improvements on functional skills in extremely preterm children.",2020,"However, for both groups, single leg stance and limb strength were significantly improved from baseline to 1 year follow-up.
","['Forty-eight (96', 'extremely low birthweight children with minimal/mild impairment', 'extremely preterm children', 'Fifty children aged 4\u2009years, born <28\u2009weeks gestation and/or birthweight <1000\u2009g with minimal/mild motor impairment', 'extremely low birthweight children with minimal/mild motor impairment']","['group-based physiotherapy', 'standard care']","['functional skills', 'single leg stance and limb strength', 'MABC-2 manual dexterity, aiming/catching and total score', 'MABC-2', 'Movement Assessment Battery for Children-2 (MABC-2), single leg stance, lateral reach and long jump']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}]",50.0,0.176483,"However, for both groups, single leg stance and limb strength were significantly improved from baseline to 1 year follow-up.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Growth and Development Unit, Mater Health Services, Brisbane, Queensland, Australia.'}, {'ForeName': 'Yvonne R', 'Initials': 'YR', 'LastName': 'Burns', 'Affiliation': 'Growth and Development Unit, Mater Health Services, Brisbane, Queensland, Australia.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Watter', 'Affiliation': 'School of Health and Rehabilitation, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kristen S', 'Initials': 'KS', 'LastName': 'Gibbons', 'Affiliation': 'Mater Research Institute, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gray', 'Affiliation': 'Growth and Development Unit, Mater Health Services, Brisbane, Queensland, Australia.'}]",Journal of paediatrics and child health,['10.1111/jpc.14712']
1645,31821664,Randomised controlled trial: Shoulder-umbilicus length versus body weight measurement for optimal endotracheal tube depth estimation in ventilated infants.,"AIM


The optimal placement of the endotracheal tube (ETT) in ventilated infants is essential, but birthweight may be not the best parameter to predict it. The aim of this study was a direct comparison of shoulder-umbilical length (experimental group) versus birthweight (control group) as predictor of optimal ETT placement in Malaysian ventilated infants.
METHODS


All infants requiring ventilation in the neonatal intensive care unit of a tertiary hospital in Malaysia during the 4-month study period were eligible to enter this randomised controlled trial. All participants were randomised into two groups: experimental and control group. The main outcome measure was malposition of the ETT (requiring adjustment), as seen on the chest X-ray performed within 1 h after intubation. Tube placement was assessed by two neonatologists, blinded to the allocation.
RESULTS


One hundred and ten infants were randomised, 55 in each group. The ETT was malpositioned in 13 of 55 infants (23%) for the experimental group and 22 of 55 infants (40%) in the control group (P = 0.06).
CONCLUSION


In the experimental group, fewer infants showed a need for tube adjustment than in the control group. While a larger study may be necessary to show statistical significance, the difference shown in this study may be large enough to be of clinical significance.",2020,"In the experimental group, fewer infants showed a need for tube adjustment than in the control group.","['One hundred and ten infants', 'Malaysian ventilated infants', 'ventilated infants', 'All infants requiring ventilation in the neonatal intensive care unit of a tertiary hospital in Malaysia during the 4-month study period']","['Shoulder-umbilicus length versus body weight measurement', 'endotracheal tube (ETT', 'shoulder-umbilical length (experimental group) versus birthweight (control group']","['malposition of the ETT (requiring adjustment), as seen on the chest X-ray']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0041638', 'cui_str': 'Umbilicus'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0333042', 'cui_str': 'Malposition (morphologic abnormality)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0039985', 'cui_str': 'Radiologic examination of chest'}]",110.0,0.123552,"In the experimental group, fewer infants showed a need for tube adjustment than in the control group.","[{'ForeName': 'Adam Al-Anas Bin', 'Initials': 'AAB', 'LastName': 'Mat Ali', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}, {'ForeName': 'Ariffin', 'Initials': 'A', 'LastName': 'Nasir', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}, {'ForeName': 'Noraida', 'Initials': 'N', 'LastName': 'Ramli', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}, {'ForeName': 'Nor R', 'Initials': 'NR', 'LastName': 'Ibrahim', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Van Rostenberghe', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}]",Journal of paediatrics and child health,['10.1111/jpc.14705']
1646,30817436,"A deeper look at pain variability and its relationship with the placebo response: results from a randomized, double-blind, placebo-controlled clinical trial of naproxen in osteoarthritis of the knee.","Previous studies have shown a robust correlation between variability of clinical pain scores and responsiveness to placebo (but not active drug) in pain studies, but explanations for these relationships are lacking. We investigated this further by assessing relationship between the Focused Analgesia Selection Test (FAST), a psychophysical method that quantifies pain reporting variability in response to experimental stimuli, variability of daily clinical pain scores as captured using diary, and response to treatment in the context of a randomized controlled crossover trial of naproxen vs placebo in knee osteoarthritis. Evoked pain using the Staircase-Evoked Pain Procedure served as the primary efficacy endpoint. Variability of daily pain scores and the FAST were assessed at baseline. Fifty-five subjects completed the study and were included in the analyses. Our results indicated a statistically significant, moderate linear relationship between variability of clinical and experimental pain reports (r = -0.416, P = 0.004). Both correlated with the placebo response (r = 0.393, P = 0.004; r =-0.371, P = 0.009; respectively), but only the FAST predicted the treatment difference between naproxen and placebo, as demonstrated both in a regression model (P = 0.002, Beta = 0.456, t = 3.342) and in a receiver operating characteristic curve (0.721) analysis. Our results extend previous findings to include a correlation between experimental pain variability and the placebo response and suggest that experimental pain variability is a better predictor of patients who respond preferentially to drug over placebo. A theoretical model unifying these observations is proposed, and practical implications are discussed.",2019,"Both correlated with the placebo response (r = 0.393, P = 0.004; r =-0.371, P = 0.009; respectively), but only the FAST predicted the treatment difference between naproxen and placebo, as demonstrated both in a regression model (P = 0.002, Beta = 0.456, t = 3.342) and in a receiver operating characteristic curve (0.721) analysis.","['osteoarthritis of the knee', 'knee osteoarthritis', 'Fifty-five subjects completed the study and were included in the analyses']","['naproxen vs placebo', 'naproxen', 'placebo']","['Variability of daily pain scores', 'Evoked pain']","[{'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",55.0,0.482892,"Both correlated with the placebo response (r = 0.393, P = 0.004; r =-0.371, P = 0.009; respectively), but only the FAST predicted the treatment difference between naproxen and placebo, as demonstrated both in a regression model (P = 0.002, Beta = 0.456, t = 3.342) and in a receiver operating characteristic curve (0.721) analysis.","[{'ForeName': 'Roi', 'Initials': 'R', 'LastName': 'Treister', 'Affiliation': 'The Clinical Pain Innovation Lab, The Cheryl Spencer Department of Nursing, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Honigman', 'Affiliation': 'The Clinical Pain Innovation Lab, The Cheryl Spencer Department of Nursing, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Oluwadolapo D', 'Initials': 'OD', 'LastName': 'Lawal', 'Affiliation': 'Analgesic Solutions, Wayland, MA, United States.'}, {'ForeName': 'Ryan K', 'Initials': 'RK', 'LastName': 'Lanier', 'Affiliation': 'Analgesic Solutions, Wayland, MA, United States.'}, {'ForeName': 'Nathaniel P', 'Initials': 'NP', 'LastName': 'Katz', 'Affiliation': 'Analgesic Solutions, Wayland, MA, United States.'}]",Pain,['10.1097/j.pain.0000000000001538']
1647,24659838,Landmark Estimation of Survival and Treatment Effect in a Randomized Clinical Trial.,"In many studies with a survival outcome, it is often not feasible to fully observe the primary event of interest. This often leads to heavy censoring and thus, difficulty in efficiently estimating survival or comparing survival rates between two groups. In certain diseases, baseline covariates and the event time of non-fatal intermediate events may be associated with overall survival. In these settings, incorporating such additional information may lead to gains in efficiency in estimation of survival and testing for a difference in survival between two treatment groups. If gains in efficiency can be achieved, it may then be possible to decrease the sample size of patients required for a study to achieve a particular power level or decrease the duration of the study. Most existing methods for incorporating intermediate events and covariates to predict survival focus on estimation of relative risk parameters and/or the joint distribution of events under semiparametric models. However, in practice, these model assumptions may not hold and hence may lead to biased estimates of the marginal survival. In this paper, we propose a semi-nonparametric two-stage procedure to estimate and compare  t -year survival rates by incorporating intermediate event information observed before some landmark time, which serves as a useful approach to overcome semi-competing risks issues. In a randomized clinical trial setting, we further improve efficiency through an additional calibration step. Simulation studies demonstrate substantial potential gains in efficiency in terms of estimation and power. We illustrate our proposed procedures using an AIDS Clinical Trial Protocol 175 dataset by estimating survival and examining the difference in survival between two treatment groups: zidovudine and zidovudine plus zalcitabine.",2014,"In these settings, incorporating such additional information may lead to gains in efficiency in estimation of survival and testing for a difference in survival between two treatment groups.",[],['zidovudine and zidovudine plus zalcitabine'],"['survival rates', 'survival', 'overall survival']",[],"[{'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0012132', 'cui_str': 'Zalcitabine'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.110883,"In these settings, incorporating such additional information may lead to gains in efficiency in estimation of survival and testing for a difference in survival between two treatment groups.","[{'ForeName': 'Layla', 'Initials': 'L', 'LastName': 'Parast', 'Affiliation': 'RAND Corporation, Santa Monica, CA 90401.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Stanford University, Department of Health, Research and Policy, Stanford, CA 94305.'}, {'ForeName': 'Tianxi', 'Initials': 'T', 'LastName': 'Cai', 'Affiliation': 'Harvard University, Department of Biostatistics, Boston, MA 02115.'}]",Journal of the American Statistical Association,[]
1648,30690869,Acceptability of locally-produced Ready-to-Use Supplementary Food (RUSF) for children under two years in Cambodia: A cluster randomised trial.,"In Cambodia, existing food products for treating or preventing undernutrition have met with limited success. Therefore, in 2014, alternative ready-to-use foods were developed. This trial aimed to assess the acceptability of the novel ready-to-use supplementary food (RUSF) as a snack or mixed with borbor (white rice porridge), compared with corn-soy blend plus plus (CSB++) and borbor fortified with micronutrient powder (MNP). The nonblinded, randomised 4 × 4 crossover trial recruited 95 children aged 9-23 months from communities in peri-urban Phnom Penh. Small quantities (100 g for porridges, 42 g for snack) of each food were offered for three consecutive days at testing sites (homes of health volunteers). Main outcomes were children's consumption, caregivers' assessment of children's preferences, and caregivers' ranking of the foods. Median percentage consumed of the test food servings ranged from 21 to 50% (p = 0.003). The odds of children consuming over 50% were greatest for borbor fortified with MNP versus RUSF snack (unadjusted OR = 6.79, CI = 2.80-16.47, p < 0.001). However, the median energy children received when consuming the RUSF with borbor (57 kcals) or as a snack (48 kcals) was greater than with CSB++ (15 kcals) or borbor fortified with MNP (18 kcals; p < 0.001). Therefore, although children ate less RUSF, it provided approximately three times more kilocalories. Caregivers reported that their children had the highest preference for borbor fortified with MNP. Caregivers themselves ranked the novel RUSF snack highest. Thus, the innovative RUSF was considered sufficiently acceptable to proceed to an effectiveness trial.",2019,Median percentage consumed of the test food servings ranged from 21 to 50% (p = 0.003).,"['95 children aged 9-23\xa0months from communities in peri-urban Phnom Penh', 'children under two years in Cambodia']","['corn-soy blend plus plus (CSB++) and borbor fortified with micronutrient powder (MNP', 'locally-produced Ready-to-Use Supplementary Food (RUSF', 'novel ready-to-use supplementary food (RUSF']","[""children's consumption, caregivers' assessment of children's preferences, and caregivers' ranking of the foods""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006797', 'cui_str': 'Khmer Republic'}]","[{'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}]",95.0,0.150168,Median percentage consumed of the test food servings ranged from 21 to 50% (p = 0.003).,"[{'ForeName': 'Bindi', 'Initials': 'B', 'LastName': 'Borg', 'Affiliation': 'School of Public Health, Faculty of Medicine, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mihrshahi', 'Affiliation': 'School of Public Health, Faculty of Medicine, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'School of Public Health, Faculty of Medicine, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Daream', 'Initials': 'D', 'LastName': 'Sok', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Chamnan', 'Initials': 'C', 'LastName': 'Chhoun', 'Affiliation': 'Department of Fisheries Post-Harvest Technologies and Quality Control, Fisheries Administration, Ministry of Agriculture, Forestry and Fisheries, Phnom Penh, Cambodia.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Laillou', 'Affiliation': 'Child Survival and Development Section, UNICEF, Phnom Penh, Cambodia.'}, {'ForeName': 'Frank T', 'Initials': 'FT', 'LastName': 'Wieringa', 'Affiliation': 'UMR-204 Nutripass, Institut de Recherche pour le Développement, IRD/UM/SupAgro, Montpellier, France.'}]",Maternal & child nutrition,['10.1111/mcn.12780']
1649,29024499,Male partner involvement on initiation and sustainment of exclusive breastfeeding among HIV-infected post-partum women: Study protocol for a randomized controlled trial.,"Exclusive Breastfeeding (EBF) among human immunodeficiency virus (HIV)-infected mothers is known to be associated with a sustained and significant reduction in HIV transmission and has the potential to reduce infant and under-five mortality. Research shows that EBF is not common in many HIV-endemic, resource-limited settings despite recommendations by the World Health Organization. Although evidence abounds that male partner involvement increases HIV testing and uptake and retention of prevention of mother-to-child transmission interventions, few studies have evaluated the impact of male partners' involvement and decision-making on initiation, maintenance, and sustainment of EBF. We propose a comparative effectiveness trial of Men's Club as intervention group compared to the control group on initiation and sustainment of EBF. Men's Club will provide male partners of HIV-infected pregnant women one 5-hr interactive educational intervention to increase knowledge on EBF and explore barriers and facilitators of EBF and support. Additionally, participating male partners in the Men's Club as intervention group will receive weekly text message reminders during the first 6-week post-natal period to improve initiation and sustainment of EBF. Participants in the Men's Club as control group will receive only educational pamphlets. Primary outcomes are the differences in the rates of initiation and sustainment of EBF at 6 months between the two groups. Secondary outcomes are differences in male partner knowledge of infant feeding options and the intent to support EBF in the two groups. Understanding the role and impact of male partners on the EBF decision-making process will inform the development of effective and sustainable evidence-based interventions to support the initiation and sustainment of EBF.",2018,Primary outcomes are the differences in the rates of initiation and sustainment of EBF at 6 months between the two groups.,"['male partners', 'male partners of HIV-infected pregnant women one 5-hr', 'Male partner involvement on initiation and sustainment of exclusive breastfeeding among HIV-infected post-partum women']","['interactive educational intervention', 'control group on initiation and sustainment of EBF', 'EBF', 'Exclusive Breastfeeding (EBF']","['rates of initiation and sustainment of EBF', 'male partner knowledge of infant feeding options and the intent to support EBF']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}]","[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",,0.0279947,Primary outcomes are the differences in the rates of initiation and sustainment of EBF at 6 months between the two groups.,"[{'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Ihekuna', 'Affiliation': 'Institute of Child Health, University of Nigeria Teaching Hospital, Enugu, Nigeria.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Rosenburg', 'Affiliation': 'Nevada State College, Henderson, Nevada, USA.'}, {'ForeName': 'William Nii Ayitey', 'Initials': 'WNA', 'LastName': 'Menson', 'Affiliation': 'Global Health Initiative, School of Community Health Sciences, University of Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'Semiu Olatunde', 'Initials': 'SO', 'LastName': 'Gbadamosi', 'Affiliation': 'Global Health Initiative, School of Community Health Sciences, University of Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'John Olajide', 'Initials': 'JO', 'LastName': 'Olawepo', 'Affiliation': 'Catholic Caritas Foundation of Nigeria, Abuja, Nigeria.'}, {'ForeName': 'Adaeze', 'Initials': 'A', 'LastName': 'Chike-Okoli', 'Affiliation': 'School of Social Science and Science Education, Federal University of Technology, Minna, Nigeria.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Cross', 'Affiliation': 'Nevada State College, Henderson, Nevada, USA.'}, {'ForeName': 'Chima', 'Initials': 'C', 'LastName': 'Onoka', 'Affiliation': 'Department of Community Medicine, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Echezona E', 'Initials': 'EE', 'LastName': 'Ezeanolue', 'Affiliation': 'Global Health Initiative, School of Community Health Sciences, University of Nevada, Las Vegas, Nevada, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12545']
1650,30920631,The role of bacteriotherapy in the prevention of adenoidectomy.,"OBJECTIVE


Adenoidectomy is a surgical procedure with potential adverse events. Effective nonsurgical therapy could reduce patient risk and harm. The aim of this study was to evaluate the role of bacteriotherapy to reduce the necessity of adenoid surgery.
PATIENTS AND METHODS


This experimental study was conducted as an open study in 44 children (30 males and 14 females, mean age 4.9 years) who were candidates for adenoidectomy and tympanocentesis as treatment for adenoidal hypertrophy and otitis media with effusion. Twenty-two children were treated with Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray, administered as 2 puffs per nostril twice a day for a week for 3 months (study group). The other half of the children was treated with hypertonic saline nasal lavage on the same schedule (control group). Tympanometry and adenoid size assessment were evaluated throughout the intervention period.
RESULTS


In the study group, 6/22 children required surgery, compared to 20/22 children in the study group (p<0.0001). The clinical change in the treated children was a significant reduction of adenoid size (p<0.0001) and improvement of middle ear effusion measured with tympanometry (p<0.0001).
CONCLUSIONS


Bacteriotherapy with Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray could significantly reduce the need for adenoid surgery.",2019,"The clinical change in the treated children was a significant reduction of adenoid size (p<0.0001) and improvement of middle ear effusion measured with tympanometry (p<0.0001).
","['44 children (30 males and 14 females, mean age 4.9 years) who were candidates for adenoidectomy and tympanocentesis as treatment for adenoidal hypertrophy and otitis media with effusion']","['bacteriotherapy', 'hypertonic saline nasal lavage', 'Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray']","['adenoid size', 'patient risk and harm', 'middle ear effusion', 'Tympanometry and adenoid size assessment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C3266817', 'cui_str': 'Tympanocentesis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids (disorder)'}, {'cui': 'C0029883', 'cui_str': 'Otitis Media, Secretory'}]","[{'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C2350442', 'cui_str': 'Nasal Irrigation'}, {'cui': 'C0318179', 'cui_str': 'Streptococcus salivarius'}, {'cui': 'C0318174', 'cui_str': 'Streptococcus oralis'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}]","[{'cui': 'C0426463', 'cui_str': 'Adenoids size'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0029883', 'cui_str': 'Otitis Media, Secretory'}, {'cui': 'C0085853', 'cui_str': 'Tympanometry'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",44.0,0.0342745,"The clinical change in the treated children was a significant reduction of adenoid size (p<0.0001) and improvement of middle ear effusion measured with tympanometry (p<0.0001).
","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'La Mantia', 'Affiliation': 'Associazione Italiana Vie Aeree Superiori, Naples, Italy. gio.cip@libero.it.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Varricchio', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Di Girolamo', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Minni', 'Affiliation': ''}, {'ForeName': 'G C', 'Initials': 'GC', 'LastName': 'Passali', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ciprandi', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201903_17348']
1651,32407239,Effects of histamine-receptor antagonism on leg blood flow during exercise.,"Histamine mediates vasodilation during inflammatory and immune responses as well as following endurance exercise. During exercise, intramuscular histamine concentration increases and its production appears related to exercise intensity and duration. However, whether histamine contributes to exercise hyperemia and promotes exercise blood flow in an intensity or duration dependent pattern is unknown. The purpose of this study was to compare leg blood flow across a range of exercise intensities, before and after prolonged exercise, with and without histamine-receptor antagonism. It was hypothesized that combined oral histamine H 1 /H 2 -receptor antagonism would decrease leg blood flow and the effect would be greater at higher intensities and following prolonged exercise. Sixteen (7F, 9M) volunteers performed single-leg knee-extension exercise after consuming either Placebo or combined histamine H 1 /H 2 -receptor antagonists (Blockade). Exercise consisted of two graded protocols at 20, 40, 60, and 80% of peak power, separated by 60 min of knee-extension exercise at 60% of peak power. Femoral artery blood flow was measured by ultrasonography. Femoral artery blood flow increased with exercise intensity up to 2660±97 ml·min -1  at 80% of peak power during Placebo (P<0.05). Blood flow was further elevated with Blockade to 2836±124 ml·min -1  (P<0.05) at 80% peak power (9.1 ± 4.8% higher than Placebo). These patterns were not affected by prolonged exercise (P=0.13). On average, femoral blood flow during prolonged exercise was 12.7± 2.8% higher with Blockade versus Placebo (P<0.05). Contrary to the hypothesis, these results suggest that histamine-receptor antagonism during exercise, regardless of intensity or duration, increases leg blood flow measured by ultrasonography.",2020,Blood flow was further elevated with Blockade to 2836±124 ml·min -1  (P<0.05) at 80% peak power (9.1 ± 4.8% higher than Placebo).,[],"['Placebo', 'single-leg knee-extension exercise after consuming either Placebo or combined histamine H 1 /H 2 -receptor antagonists (Blockade', 'histamine-receptor antagonism', 'histamine', 'Histamine']","['leg blood flow', 'Blood flow', 'Femoral artery blood flow', 'femoral blood flow']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0034813', 'cui_str': 'Histamine receptor'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",,0.0688832,Blood flow was further elevated with Blockade to 2836±124 ml·min -1  (P<0.05) at 80% peak power (9.1 ± 4.8% higher than Placebo).,"[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Ely', 'Affiliation': 'Department of Human Physiology, University of Oregon, United States.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ratchford', 'Affiliation': 'University of Utah, United States.'}, {'ForeName': 'D Taylor', 'Initials': 'DT', 'LastName': 'La Salle', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, United States.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Trinity', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, United States.'}, {'ForeName': 'D Walter', 'Initials': 'DW', 'LastName': 'Wray', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, United States.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Halliwill', 'Affiliation': 'Department of Human Physiology, University of Oregon, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00689.2019']
1652,31838255,"Strategy of blood pressure intervention in the elderly hypertensive patients (STEP): Rational, design, and baseline characteristics for the main trial.","The optimal systolic blood pressure (SBP) treatment target in elderly people is full of challenge, and non-adherence is one major cause of uncontrolled BP. The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial is a multi-center, randomized controlled trial that aims to examine whether an intensive treatment (110 ≤ SBP < 130 mmHg) will provide more benefits in lowering cardiovascular events than a mild treatment (130 ≤ SBP < 150 mmHg) among people aged 60-80 years. From January 10, 2017 to December 31, 2017, 8511 patients with primary hypertension were recruited at 42 clinical centers throughout China and randomly assigned to the intensive or standard treatment in 1:1 ratio, in which clinical sites are considered as a stratification factor in randomization. Participants will be followed for an average of four years. All participants used the same validated home BP device and all centers used the same validated office BP device which can automatically upload the readings to a data center. The hospitals were randomly classified as the smartphone-based App center or usual care center in 1:1 ratio for the secondary purpose to study the effect of App management on BP control. In this trial, mean age of participants was 66.2 ± 4.8 years, 24.1% were in the range of 70-80 years, and 65% were at high-risk with the 10-year Framingham risk score ≥ 15%. In conclusion, STEP will provide evidence not only to address appropriate target of BP control among hypertensive patients aged 60-80 years, but also to assess an effective model of App management for hypertension. Trial Registration number: ClinicalTrials. gov. Unique identifier: NCT03015311.",2020,"The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial is a multi-center, randomized controlled trial that aims to examine whether an intensive treatment (110 ≤ SBP < 130 mmHg) will provide more benefits in lowering cardiovascular events than a mild treatment (130 ≤ SBP < 150 mmHg) among people aged 60-80 years.","['elderly hypertensive patients (STEP', 'Elderly Hypertensive Patients (STEP', 'hypertensive patients aged 60-80\u202fyears', 'elderly people', 'people aged 60-80\u202fyears', 'From January 10, 2017 to December 31, 2017, 8511 patients with primary hypertension were recruited at 42 clinical centers throughout China', 'mean age of participants was 66.2\u202f±\u202f4.8\u202fyears, 24.1% were in the range of 70-80\u202fyears, and 65% were at high-risk with the 10-year Framingham risk score\u202f≥\u202f15']","['blood pressure intervention', 'intensive treatment (110\u202f≤\u202fSBP\u202f<\u202f130\u202fmmHg', 'smartphone-based App center or usual care center', 'Blood Pressure Intervention']",['optimal systolic blood pressure (SBP'],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",,0.0860429,"The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial is a multi-center, randomized controlled trial that aims to examine whether an intensive treatment (110 ≤ SBP < 130 mmHg) will provide more benefits in lowering cardiovascular events than a mild treatment (130 ≤ SBP < 150 mmHg) among people aged 60-80 years.","[{'ForeName': 'Shuyuan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Hypertension Center, FuWai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100037, China.'}, {'ForeName': 'Shouling', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Kailuan General Hospital, Tangshan, Hebei 063000, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'Shanxi Academy of Medical Sciences, Shanxi Dayi Hospital, Taiyuan, Shanxi 030032, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.'}, {'ForeName': 'Xinjun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.'}, {'ForeName': 'Yingqing', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Guangdong Cardiovascular Institute, Guangzhou, Guangdong 510080, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, China.'}, {'ForeName': 'Bingpo', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Kang Ya Hospital, Yiyang, Hunan 413000, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""The People's Hospital of Ji Xian District, Tianjin 301900, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Tian', 'Affiliation': ""First Affiliated Hospital, Xian Jiaotong University, Xi'an, Shanxi 710061, China.""}, {'ForeName': 'Yinong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'The 1st Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China.'}, {'ForeName': 'Zihong', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Fuwai Yunnan Cardiovascular Hospital, Kunming, Yunnan 650106, China.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Pingjin Hospital, Logistics University of PAPF, Tianjin 300162, China.'}, {'ForeName': 'Tzung-Dau', 'Initials': 'TD', 'LastName': 'Wang', 'Affiliation': 'College of Medicine, National Taiwan University, Taipei, Taiwan 10051, China.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Jichi Medical University School of Medicine (JMU), Shimotsuke, Tochigi 329-0498, Japan.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Hypertension Center, FuWai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100037, China. Electronic address: zhangweili1747@yahoo.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Hypertension Center, FuWai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100037, China. Electronic address: caijun7879@126.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2019.105913']
1653,30897067,THE EFFECT OF AGE ON AFLIBERCEPT (EYLEA) RESPONSE IN DIABETIC MACULAR EDEMA.,"PURPOSE


To investigate the effect of age on aflibercept (Eylea) response in macular edema secondary to treatment-naive diabetic eyes.
METHODS


Two hundred seventy-three eyes of 273 treatment-naive patients with macular edema secondary to diabetes mellitus were enrolled in this study. The patients in the study were divided into the following 4 groups according to their ages: Group 1 (40-50 years), Group 2 (51-60 years), Group 3 (61-70 years), and Group 4 (>70 years). Three consecutive injections at intervals of 1 month were applied to all diabetic patients. The efficacy of the aflibercept treatment on macular edema according to age groups was assessed by optical coherence tomography by comparing the central foveal thickness (CFT) values and mean visual acuity changes after initial and three loading dose injections.
RESULTS


After three consecutive aflibercept injections, the mean reduction of CFT in Groups 1, 2, 3, and 4 were -256.4 ± 110.9, -197.4 ± 96.4, -189.4 ± 110.8, and -186.2 ± 118.9 µm, respectively. The changes of CFT was significantly different between age groups (P = 0.003, analysis of covariance). The improvement of visual acuity was significantly different in each group (P < 0.001 in all groups, paired-samples t-test), and changes of visual acuity was significantly different between age groups (P < 0.05, analysis of covariance). In addition, ages of patients were correlated with the mean reduction of CFT and mean improvement of visual acuity for the whole study group (r = -0.183, P = 0.002 for CFT; r = -0.682, P < 0.001 for visual acuity, Pearson correlation).
CONCLUSION


In this study, it was observed that the efficacy of aflibercept treatment was found to be more effective in younger patients in treatment-naive diabetic macular edema patients.",2020,"The changes of CFT was significantly different between age groups (P = 0.003, analysis of covariance).","['younger patients in treatment-naive diabetic macular edema patients', 'macular edema secondary to treatment-naive diabetic eyes', 'Two hundred seventy-three eyes of 273 treatment-naive patients with macular edema secondary to diabetes mellitus']","['aflibercept', 'aflibercept (Eylea) response', 'THE EFFECT OF AGE ON AFLIBERCEPT (EYLEA']","['macular edema', 'changes of CFT', 'visual acuity', 'changes of visual acuity', 'central foveal thickness (CFT) values and mean visual acuity changes', 'improvement of visual acuity', 'mean reduction of CFT']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3248025', 'cui_str': 'Eylea'}]","[{'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",273.0,0.0287596,"The changes of CFT was significantly different between age groups (P = 0.003, analysis of covariance).","[{'ForeName': 'Cemal', 'Initials': 'C', 'LastName': 'Ozsaygili', 'Affiliation': 'Kayseri City Training and Research Hospital, Kocasinan, Kayseri, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Duru', 'Affiliation': ''}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Cicek', 'Affiliation': ''}, {'ForeName': 'Dondu Melek', 'Initials': 'DM', 'LastName': 'Ulusoy', 'Affiliation': ''}, {'ForeName': 'Atilim Armagan', 'Initials': 'AA', 'LastName': 'Demirtas', 'Affiliation': ''}, {'ForeName': 'Necati', 'Initials': 'N', 'LastName': 'Duru', 'Affiliation': ''}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002504']
1654,30893689,Parallel Exploratory RCT of Polyethylene Wrap for Heat Loss Prevention in Infants Born at Less than 24 Weeks' Gestation.,"BACKGROUND


The treatment effect of occlusive wrap applied immediately after delivery in infants born 24-28 weeks' gestation has been studied, but the effect is not known in infants born at less than 240/7 weeks' gestation.
OBJECTIVES


To determine if the use of occlusive wrap applied immediately after birth in infants born at less than 240/7 weeks' gestation results in any differences in outcomes when compared to non-wrapped infants.
METHODS


Parallel exploratory randomized controlled trial with a convenience sample of 28 inborn infants born at less than 240/7 weeks' gestation enrolled during the duration of the HeLP trial. Infants were randomized to either the wrap or standard of care (no wrap) group.
RESULTS


Twenty-eight infants (wrap n = 14; no wrap n = 14) were randomized and data on all infants was available for intention-to-treat analysis. There were no differences in baseline population characteristics. There was no statistically significant difference in mortality (n = 8/14 wrap, 8/14 no wrap). There was no statistically significant difference in baseline temperature (35.9°C, SD = 1.12, wrap vs. 35.1°C, SD = 1.16, no wrap, p = 0.16) or post-stabilization temperature (36.4°C, SD = 0.84, wrap vs. 36.1°C, SD = 1.2, no wrap, p = 0.56). There was a trend towards increased baseline temperature in the wrap group.
CONCLUSION


Application of occlusive wrap to infants born at less than 240/7 weeks' gestation immediately after birth did not reduce mortality or effect baseline or post-stabilization temperature in this small exploratory study. This small sample provides the first estimate of treatment effect for this high-risk population.",2019,"There was no statistically significant difference in mortality (n = 8/14 wrap, 8/14 no wrap).","[""infants born at less than 240/7 weeks' gestation"", 'Twenty-eight infants (wrap n = 14; no wrap n = 14', ""infants born 24-28 weeks' gestation"", ""28 inborn infants born at less than 240/7 weeks' gestation enrolled during the duration of the HeLP trial"", 'Infants']",['wrap or standard of care (no wrap) group'],"['baseline temperature', 'mortality', 'post-stabilization temperature']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0445414', 'cui_str': 'Wrapping (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0445414', 'cui_str': 'Wrapping (procedure)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]",28.0,0.146163,"There was no statistically significant difference in mortality (n = 8/14 wrap, 8/14 no wrap).","[{'ForeName': 'Maureen C', 'Initials': 'MC', 'LastName': 'Reilly', 'Affiliation': 'Women and Babies Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada, maureen.reilly@sunnybrook.ca.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Vohra', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Valeria E', 'Initials': 'VE', 'LastName': 'Rac', 'Affiliation': 'Women and Babies Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Zayack', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wimmer', 'Affiliation': ""Women's Hospital of Greensboro, Cone Health, Greensboro, North Carolina, USA.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vincer', 'Affiliation': 'Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Ferrelli', 'Affiliation': 'Vermont Oxford Network, Burlington, Vermont, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Department of Research Design and Biostatistics, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Roger F', 'Initials': 'RF', 'LastName': 'Soll', 'Affiliation': 'Vermont Oxford Network, Department of Newborn-Perinatal Medicine, Burlington, Vermont, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dunn', 'Affiliation': 'Women and Babies Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}]",Neonatology,['10.1159/000497253']
1655,31561882,Cost-effectiveness Analysis of Empagliflozin in Japan Based on Results From the Asian subpopulation in the EMPA-REG OUTCOME Trial.,"PURPOSE


The goal of this study was to assess the cost-effectiveness of empagliflozin in Japan based on the Asian subpopulation in the EMPA-REG OUTCOME trial.
METHODS


The trial has shown a reduction in the risk for cardiovascular (CV) and renal events with empagliflozin in patients with type 2 diabetes mellitus and established CV disease. A cost-effectiveness analysis based on the overall population of the EMPA-REG OUTCOME trial was reported previously by using a lifetime discrete event simulation model. The same modeling frame was adapted to evaluate the cost-effectiveness of treatment with empagliflozin added to standard of care (SoC) compared with SoC alone in Japan. The time to relevant clinical events and the hazard ratios were derived from an Asian subpopulation in the EMPA-REG OUTCOME trial. The costs for each event were estimated from a Japanese medical claims database. Direct medical costs, life expectancy, and quality-adjusted life years (QALYs) were calculated from the public health care perspective.
FINDINGS


Treatment with empagliflozin was estimated to increase life expectancy by 6.2 years and 2.7 QALYs, whereas total cost increased by 1,115,475 yen compared with treatment with SoC alone. The incremental cost-effectiveness ratio was 415,849 yen/QALY. In the sensitivity analysis, there was no case that was in excess of the reference value of the incremental cost-effectiveness ratio in the pilot introduction for price revision in Japan (ie, 5 million yen/QALY).
IMPLICATIONS


Based on the Asian subpopulation in the EMPA-REG OUTCOME trial, our results suggest that empagliflozin added to SoC is highly cost-effective compared with SoC alone in Japan.",2019,"In the sensitivity analysis, there was no case that was in excess of the reference value of the incremental cost-effectiveness ratio in the pilot introduction for price revision in Japan (ie, 5 million yen/QALY).
","['Japan', 'Japan based on the Asian population in the EMPA-REG OUTCOME trial', 'patients with type 2 diabetes mellitus and established CV disease', 'in Japan']","['Empagliflozin', 'empagliflozin', 'SoC alone']","['Direct medical costs, life expectancy, and quality-adjusted life years (QALYs', 'incremental cost-effectiveness ratio', 'total cost', 'cost-effectiveness', 'life expectancy']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0407188,"In the sensitivity analysis, there was no case that was in excess of the reference value of the incremental cost-effectiveness ratio in the pilot introduction for price revision in Japan (ie, 5 million yen/QALY).
","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Haneda', 'Affiliation': 'Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sakamaki', 'Affiliation': 'Kanagawa University of Human Services School of Health Innovation, Kawasaki, Japan.'}, {'ForeName': 'Atsutaka', 'Initials': 'A', 'LastName': 'Yasui', 'Affiliation': 'Nippon Boehringer Ingelheim Co Ltd, Tokyo, Japan. Electronic address: atsutaka.yasui@boehringer-ingelheim.com.'}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Murata', 'Affiliation': 'CRECON Medical Assessment Inc, Tokyo, Japan.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ustyugova', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim/Rhein, Germany.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Chin', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Tetsuaki', 'Initials': 'T', 'LastName': 'Hirase', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Tsunehisa', 'Initials': 'T', 'LastName': 'Shibahara', 'Affiliation': 'Nippon Boehringer Ingelheim Co Ltd, Tokyo, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Nippon Boehringer Ingelheim Co Ltd, Tokyo, Japan.'}, {'ForeName': 'Anuraag', 'Initials': 'A', 'LastName': 'Kansal', 'Affiliation': 'Evidera, Bethesda, MD, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kaspers', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim/Rhein, Germany.'}, {'ForeName': 'Tomoo', 'Initials': 'T', 'LastName': 'Okamura', 'Affiliation': 'Nippon Boehringer Ingelheim Co Ltd, Tokyo, Japan.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.07.016']
1656,30827735,Influenza vaccination of pregnant women: Engaging clinicians to reduce missed opportunities for vaccination.,"BACKGROUND


Antenatal influenza vaccination (AIV) is an effective intervention for protecting pregnant women and their newborns against influenza. Although the World Health Organization recommends AIV at any stage of pregnancy, in low- and middle-income countries, including India, it is rarely provided. Research suggests that antenatal care (ANC) provider practices explain much of this limited coverage. Our study in urban Pune, India, assessed the feasibility of a two-stage clinician-engagement strategy to reduce missed opportunities for AIV in urban private-practice ANC clinics.
METHODS


Clinicians were randomized to intervention and control groups in slum and middle-class study sites. Intervention-group clinicians (active clinicians) were assessed on vaccination-related views and practices, and were presented with authoritative AIV recommendations from global, academic and professional medical organizations. In a second meeting after a community survey, findings concerning vaccination-related views and experiences were explained to active clinicians. Assessments of community vaccination views were not provided to control-group clinicians. Both groups maintained logs of ANC clinic visit vaccination status throughout the 11-month study period to enable identification of missed and taken opportunities for vaccination. Analyses were restricted to visits of women in their third trimester without previous AIV in the current pregnancy.
RESULTS


Overall, 30 clinicians participated. After first and second interactions, active clinicians in middle-class communities vaccinated at 12.2% and 37.8%, respectively. Middle-class control clinicians vaccinated at <0.2% throughout the study. This difference in AIV taken opportunities between middle-class active and control clinics was statistically significant (p < 0.05) after first and second interactions. In slum-community sites, active clinicians' AIV activity was minimal throughout.
CONCLUSIONS


Our approach for engaging clinicians effectively reduced missed opportunities for AIV in urban middle-class settings of Pune. It may also improve maternal vaccination for other conditions. The absence of any similar effect in slum-based clinics likely reflects critical limitations of vaccine access.",2019,This difference in AIV taken opportunities between middle-class active and control clinics was statistically significant (p < 0.05) after first and second interactions.,"['protecting pregnant women and their newborns against influenza', 'pregnant women', 'urban private-practice ANC clinics', 'Clinicians']","['Antenatal influenza vaccination (AIV', 'Influenza vaccination']",['maternal vaccination'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0521124', 'cui_str': 'Against (qualifier value)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",30.0,0.0406824,This difference in AIV taken opportunities between middle-class active and control clinics was statistically significant (p < 0.05) after first and second interactions.,"[{'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Giduthuri', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland. Electronic address: joseph.giduthuri@swisstph.ch.'}, {'ForeName': 'Vidula', 'Initials': 'V', 'LastName': 'Purohit', 'Affiliation': 'The Maharashtra Association of Anthropological Sciences, Centre for Health Research and Development, Pune, India; Savitribai Phule Pune University, Pune, India.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Maire', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Kudale', 'Affiliation': 'The Maharashtra Association of Anthropological Sciences, Centre for Health Research and Development, Pune, India; Savitribai Phule Pune University, Pune, India.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Utzinger', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schindler', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Mitchell G', 'Initials': 'MG', 'LastName': 'Weiss', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}]",Vaccine,['10.1016/j.vaccine.2019.02.035']
1657,30304644,The effects and costs of home-based rehabilitation for heart failure with reduced ejection fraction: The REACH-HF multicentre randomized controlled trial.,"BACKGROUND


Cardiac rehabilitation improves health-related quality of life (HRQoL) and reduces hospitalizations in patients with heart failure, but international uptake of cardiac rehabilitation for heart failure remains low.
DESIGN AND METHODS


The aim of this multicentre randomized trial was to compare the REACH-HF (Rehabilitation EnAblement in CHronicHeart Failure) intervention, a facilitated self-care and home-based cardiac rehabilitation programme to usual care for adults with heart failure with reduced ejection fraction (HFrEF). The study primary hypothesis was that the addition of the REACH-HF intervention to usual care would improve disease-specific HRQoL (Minnesota Living with Heart Failure questionnaire (MLHFQ)) at 12 months compared with usual care alone.
RESULTS


The study recruited 216 participants, predominantly men (78%), with an average age of 70 years and mean left ventricular ejection fraction of 34%. Overall, 185 (86%) participants provided data for the primary outcome. At 12 months, there was a significant and clinically meaningful between-group difference in the MLHFQ score of -5.7 points (95% confidence interval -10.6 to -0.7) in favour of the REACH-HF intervention group ( p = 0.025). With the exception of patient self-care ( p < 0.001) there was no significant difference in other secondary outcomes, including clinical events ( p > 0.05) at follow-up compared with usual care. The mean cost of the REACH-HF intervention was £418 per participant.
CONCLUSIONS


The novel REACH-HF home-based facilitated intervention for HFrEF was clinically superior in disease-specific HRQoL at 12 months and offers an affordable alternative to traditional centre-based programmes to address current low cardiac rehabilitation uptake rates for heart failure.",2019,"With the exception of patient self-care ( p < 0.001) there was no significant difference in other secondary outcomes, including clinical events ( p > 0.05) at follow-up compared with usual care.","['216 participants, predominantly men (78%), with an average age of 70 years and mean left ventricular ejection fraction of 34', 'adults with heart failure with reduced ejection fraction (HFrEF', 'patients with heart failure', 'heart failure with reduced ejection fraction']","['usual care alone', 'home-based rehabilitation', 'REACH-HF (Rehabilitation EnAblement in CHronicHeart Failure) intervention, a facilitated self-care and home-based cardiac rehabilitation programme']","['MLHFQ score', 'health-related quality of life (HRQoL', 'clinical events', 'mean cost of the REACH-HF intervention', 'disease-specific HRQoL (Minnesota Living with Heart Failure questionnaire (MLHFQ']","[{'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",216.0,0.130828,"With the exception of patient self-care ( p < 0.001) there was no significant difference in other secondary outcomes, including clinical events ( p > 0.05) at follow-up compared with usual care.","[{'ForeName': 'Hasnain M', 'Initials': 'HM', 'LastName': 'Dalal', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': '3 Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Russell C', 'Initials': 'RC', 'LastName': 'Davis', 'Affiliation': '4 Cardiology Department, Sandwell & West Birmingham Hospitals NHS Trust, Birmingham, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Doherty', 'Affiliation': '5 Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Miles', 'Affiliation': '6 Research and Development, Aneurin Bevan University Health Board, St Woolos Hospital, Newport, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'van Lingen', 'Affiliation': '7 Duchy Hospital, Truro, UK.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Warren', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wingham', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Greaves', 'Affiliation': '8 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Sadler', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Melvyn', 'Initials': 'M', 'LastName': 'Hillsdon', 'Affiliation': '9 Sport and Health Sciences, University of Exeter, Exeter, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Abraham', 'Affiliation': '10 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Britten', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Frost', 'Affiliation': '1 Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': '11 Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hayward', 'Affiliation': '12 Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Eyre', 'Affiliation': '13 Re:Cognition Health, London, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Paul', 'Affiliation': '14 REACH-HF Patient and Public Involvement Group, c/o Research, Development & Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK.'}, {'ForeName': 'Chim C', 'Initials': 'CC', 'LastName': 'Lang', 'Affiliation': '15 School of Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': '16 School of Nursing and Health Sciences, University of Dundee, Dundee, UK.'}]",European journal of preventive cardiology,['10.1177/2047487318806358']
1658,30894423,Robot for health data acquisition among older adults: a pilot randomised controlled cross-over trial.,"BACKGROUND /OBJECTIVES


Healthcare professionals (HCP) are confronted with an increased demand for assessments of important health status measures, such as patient-reported outcome measurements (PROM), and the time this requires. The aim of this study was to investigate the effectiveness and acceptability of using an HCP robot assistant, and to test the hypothesis that a robot can autonomously acquire PROM data from older adults.
DESIGN


A pilot randomised controlled cross-over study where a social robot and a nurse administered three PROM questionnaires with a total of 52 questions.
SETTING


A clinical outpatient setting with community-dwelling older adults.
PARTICIPANTS


Forty-two community-dwelling older adults (mean age: 77.1 years, SD: 5.7 years, 45% female).
MEASUREMENTS


The primary outcome was the task time required for robot-patient and nurse-patient interactions. Secondary outcomes were the similarity of the data and the percentage of robot interactions completed autonomously. The questionnaires resulted in two values (robot and nurse) for three indexes of frailty, well-being and resilience. The data similarity was determined by comparing these index values using Bland-Altman plots, Cohen's kappa (κ) and intraclass correlation coefficients (ICC). Acceptability was assessed using questionnaires.
RESULTS


The mean robot interview duration was 16.57 min (SD=1.53 min), which was not significantly longer than the nurse interviews (14.92 min, SD=8.47 min; p=0.19). The three Bland-Altman plots showed moderate to substantial agreement between the frailty, well-being and resilience scores (κ=0.61, 0.50 and 0.45, and ICC=0.79, 0.86 and 0.66, respectively). The robot autonomously completed 39 of 42 interviews (92.8%).
CONCLUSION


Social robots may effectively and acceptably assist HCPs by interviewing older adults.",2019,"The three Bland-Altman plots showed moderate to substantial agreement between the frailty, well-being and resilience scores (κ=0.61, 0.50 and 0.45, and ICC=0.79, 0.86 and 0.66, respectively).","['interviewing older adults', 'Forty-two community-dwelling older adults (mean age: 77.1 years, SD: 5.7 years, 45% female', 'A clinical outpatient setting with community-dwelling older adults', 'older adults']","['HCP robot assistant', 'Social robots']","['Acceptability', 'similarity of the data and the percentage of robot interactions completed autonomously', 'task time required for robot-patient and nurse-patient interactions', 'mean robot interview duration', 'effectiveness and acceptability']","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0600161,"The three Bland-Altman plots showed moderate to substantial agreement between the frailty, well-being and resilience scores (κ=0.61, 0.50 and 0.45, and ICC=0.79, 0.86 and 0.66, respectively).","[{'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Boumans', 'Affiliation': 'Department of Geriatrics, Radboud University Medical Center, Nijmegen, The Netherlands roel.boumans@radboudumc.nl.'}, {'ForeName': 'Fokke', 'Initials': 'F', 'LastName': 'van Meulen', 'Affiliation': 'Department of Geriatrics, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Hindriks', 'Affiliation': 'Faculty of Electrical Engineering, Mathematics and Computer Science, Delft University of Technology, Delft, The Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Neerincx', 'Affiliation': 'Faculty of Electrical Engineering, Mathematics and Computer Science, Delft University of Technology, Delft, The Netherlands.'}, {'ForeName': 'Marcel G M', 'Initials': 'MGM', 'LastName': 'Olde Rikkert', 'Affiliation': 'Department of Geriatrics, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",BMJ quality & safety,['10.1136/bmjqs-2018-008977']
1659,30890382,"Intradermal post-exposure rabies vaccination with purified Vero cell rabies vaccine: Comparison of a one-week, 4-site regimen versus updated Thai Red Cross regimen in a randomized non-inferiority trial in the Philippines.","BACKGROUND


Rabies post-exposure prophylaxis (PEP) via intradermal (ID) administration is standard practice in Asia. Accumulating evidence suggests that PEP shortened to 3 visits in one week does not adversely affect seroconversion rates or immune memory.
OBJECTIVE


To determine whether the seroconversion rate at Day14 with a 1-week, 4-site (4-4-4-0-0) ID vaccination regimen with or without rabies immunoglobulin (RIG) was non-inferior to the updated Thai Red Cross (TRC) 28-day, 2-site (2-2-2-0-2) ID regimen with RIG during rabies PEP. We also assessed one-year antibody persistence.
METHODS


This phase III, mono-center, open-label, randomized-controlled trial assigned participants aged ≤50 years (n = 600) exposed to suspected rabid animals and sustaining WHO Category II injuries (automatic allocation to G1) or Category III injuries (randomized to G2 or G3) to the following groups (1:1:1 ratio): G1 (n = 200), 1-week 4-site ID regimen with the purified Vero cell rabies vaccine (PVRV; Verorab®) without RIG; G2 (n = 201), 1-week 4-site ID regimen with PVRV, and purified equine rabies immunoglobulin (pERIG); G3 (n = 199), TRC 28-day, 2-site ID regimen with PVRV, and pERIG. Non-inferiority tests compared G1 vs. G3 and G2 vs. G3. Seroconversion rate was the proportion (%) of vaccinees with rabies virus neutralizing antibodies (RVNA) titers ≥0.5 IU/mL measured by rapid fluorescent focus inhibition test.
RESULTS


On Day14, after the third vaccine administration, seroconversion rates were non-inferior in both comparisons and were, respectively, 100%, 99.4%, 98.8% in G1, G2, G3 with a decrease to 97.6%, 89%, 79.8% at Year 1. At Day14, RVNA geometric mean titers were 11.3 IU/mL; 9.89 IU/mL; 6.15 IU/mL, respectively, decreasing to 2.96 IU/mL, 1.37 IU/mL, 0.97 IU/mL at Year1. Safety and tolerability were similar between the three groups.
CONCLUSION


The seroconversion rate at Day 14 with the 1-week 4-site ID regimen, both with and without pERIG, was non-inferior to the reference TRC 28-day 2-site ID regimen with pERIG during rabies PEP with PVRV. ClinicalTrials.gov ID: NCT01622062.",2019,"Seroconversion rate was the proportion (%) of vaccinees with rabies virus neutralizing antibodies (RVNA) titers ≥0.5 IU/mL measured by rapid fluorescent focus inhibition test.
",['participants aged ≤50\u202fyears (n\u202f=\u202f600'],"['4-site regimen versus updated Thai Red Cross regimen', 'vaccination regimen with or without rabies immunoglobulin (RIG', 'Rabies post-exposure prophylaxis (PEP) via intradermal (ID) administration', 'suspected rabid animals and sustaining WHO Category II injuries (automatic allocation to G1) or Category III injuries (randomized to G2 or G3', 'purified Vero cell rabies vaccine (PVRV; Verorab®) without RIG; G2 (n\u202f=\u202f201), 1-week 4-site ID regimen with PVRV, and purified equine rabies immunoglobulin (pERIG); G3 (n\u202f=\u202f199), TRC 28-day, 2-site ID regimen with PVRV, and pERIG. Non-inferiority tests compared G1 vs. G3 and G2 vs. G3', 'Intradermal post-exposure rabies vaccination with purified Vero cell rabies vaccine']","['Safety and tolerability', 'seroconversion rate', 'seroconversion rates', 'seroconversion rates or immune memory', 'Seroconversion rate', 'RVNA geometric mean titers']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0034907', 'cui_str': 'Red Crescent'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0301503', 'cui_str': 'rabies immune globulin, human'}, {'cui': 'C0034494', 'cui_str': 'Hydrophobia'}, {'cui': 'C1443861', 'cui_str': 'Post-Exposure Prevention'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0042542', 'cui_str': 'Vero Cells'}, {'cui': 'C0034496', 'cui_str': 'Rabies Vaccines'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0042205', 'cui_str': 'Rabies vaccination (procedure)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.163362,"Seroconversion rate was the proportion (%) of vaccinees with rabies virus neutralizing antibodies (RVNA) titers ≥0.5 IU/mL measured by rapid fluorescent focus inhibition test.
","[{'ForeName': 'Beatriz P', 'Initials': 'BP', 'LastName': 'Quiambao', 'Affiliation': 'Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ambas', 'Affiliation': 'Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines.'}, {'ForeName': 'Sherylle', 'Initials': 'S', 'LastName': 'Diego', 'Affiliation': 'Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Bosch Castells', 'Affiliation': 'Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Korejwo', 'Affiliation': 'Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Petit', 'Affiliation': 'Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Houillon', 'Affiliation': 'Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France. Electronic address: Guy.Houillon@sanofi.com.'}]",Vaccine,['10.1016/j.vaccine.2019.02.083']
1660,30913926,Hospital Design with Nature Films Reduces Stress-Related Variables in Patients Undergoing Colonoscopy.,"PURPOSE


To examine whether patients' experiences could be improved during colonoscopy by designing the examination room to include a digital screen showing calm nature films.
BACKGROUND


Colonoscopy is the gold standard for examination of the large intestine and the rectum. Around 50% of individuals invited for colorectal cancer screening choose to refrain from the screening due to fear and anxiety. It is therefore important to improve patients' comfort during the procedure.
METHOD


One of the four endoscopy rooms was rebuilt to include a large digital screen showing calm nature films. Patients were randomized to intervention (i.e., the room showing films) or control. During the colonoscopy, pulse and oxygen saturation were measured and the patients graded the intensity of pain and anxiety. Blood samples were taken regularly during the examination and were analyzed for glucose, cortisol, and prolactin.
RESULTS


The presence of calm nature films during colonoscopy decreased the release of cortisol, increased prolactin levels, and enhanced oxygen saturation. These effects were more apparent in patients who were unfamiliar with the procedure and the environment, patients who underwent the examination without analgesics or sedation, and patients whose examination procedure was relatively difficult and took a long time.
CONCLUSIONS


The intervention described in this study is easy to implement and might help improve the patient experience during colonoscopy. However, this study was performed in a single health institution, and more studies are needed to further explore the role of film interventions in endoscopic and other medical procedures.",2019,"The presence of calm nature films during colonoscopy decreased the release of cortisol, increased prolactin levels, and enhanced oxygen saturation.",['Patients Undergoing Colonoscopy'],[],"['release of cortisol, increased prolactin levels, and enhanced oxygen saturation', 'intensity of pain and anxiety', 'pulse and oxygen saturation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",[],"[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0747979', 'cui_str': 'Increased prolactin level (finding)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}]",,0.0181241,"The presence of calm nature films during colonoscopy decreased the release of cortisol, increased prolactin levels, and enhanced oxygen saturation.","[{'ForeName': 'Annica', 'Initials': 'A', 'LastName': 'Sjölander', 'Affiliation': 'Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Jakobsson Ung', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Töres', 'Initials': 'T', 'LastName': 'Theorell', 'Affiliation': 'Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Nilsson', 'Affiliation': 'Department of Research and Development, Skaraborg Hospital, Skövde, Sweden.'}, {'ForeName': 'Kjell-Arne', 'Initials': 'KA', 'LastName': 'Ung', 'Affiliation': 'Department of Internal Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",HERD,['10.1177/1937586719837754']
1661,31570210,Effect of topical tranexamic acid in total hip arthroplasty patients who receive continuous aspirin for prevention of cardiovascular or cerebrovascular events: A prospective randomized study.,"BACKGROUND


Due to differences in pharmacological mechanism of action, the effect of tranexamic acid (TA) on aspirin-related bleeding remains unknown. We therefore conducted a prospective randomized study to elucidate: (1) the effect of topical TA administration on blood loss and transfusion rate in total hip arthroplasty (THA) patients receiving continuous aspirin for prevention of cardiovascular or cerebrovascular events; (2) 90-day complications of topical TA administration; (3) possible variables contributing to blood transfusion.
HYPOTHESIS


Topical TA administration reduces blood loss and transfusion rate in THA patients receiving continuous aspirin.
PATIENTS AND METHODS


A total of 102 consecutive THA patients taking continuous aspirin were enrolled and randomized into two groups. In the topical TA (TTA) group (n=55), topical TA was administered at three points during THA; in the control group (n=47), the patients received saline solution as placebo. Based on drop in hemoglobin concentration, total estimated blood loss was calculated as the main assessment criterion. Secondary assessment criteria included transfusion rate and 90-day complications. Finally, a multivariate regression model was used to assess possible predictive factors for blood transfusion.
RESULTS


(1) Significantly lower total blood loss was observed in the TTA group than in the control group (897±177ml vs. 1153±345ml, p<0.001). Furthermore, lower transfusion rate was observed in the TTA group than in the control group (10.9% vs. 34.0%, p=0.005). (2) No significant difference was observed between the two groups regarding 90-day complications. (3) We identified higher preoperative hemoglobin level (OR=0.675, p=0.002) and topical TA administration (OR=0.002, p=0.012) as negative predictive factors for blood transfusion.
DISCUSSION


Topical application of TA was safe and beneficial in THA patients receiving continuous aspirin for prevention of cardiovascular or cerebrovascular events, to reduce blood loss and transfusion rate, without increasing the risk of 90-day complications.",2019,"Topical application of TA was safe and beneficial in THA patients receiving continuous aspirin for prevention of cardiovascular or cerebrovascular events, to reduce blood loss and transfusion rate, without increasing the risk of 90-day complications.","['total hip arthroplasty (THA) patients receiving continuous', '102 consecutive THA patients taking continuous', 'total hip arthroplasty patients who receive continuous aspirin for prevention of cardiovascular or cerebrovascular events', 'THA patients receiving continuous aspirin', 'THA patients receiving continuous']","['tranexamic acid (TA', 'topical TA (TTA', 'TTA', 'saline solution as placebo', 'topical tranexamic acid', 'Topical TA', 'TA', 'aspirin', 'topical TA']","['transfusion rate and 90-day complications', 'cardiovascular or cerebrovascular events', 'preoperative hemoglobin level', 'total blood loss', '90-day complications', 'blood loss and transfusion rate', 'hemoglobin concentration, total estimated blood loss', 'transfusion rate']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1627773', 'cui_str': 'Tissue texture abnormality'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}]",102.0,0.039089,"Topical application of TA was safe and beneficial in THA patients receiving continuous aspirin for prevention of cardiovascular or cerebrovascular events, to reduce blood loss and transfusion rate, without increasing the risk of 90-day complications.","[{'ForeName': 'Jiandi', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Department of Adult Reconstruction, The Third Affiliated Hospital of Wenzhou Medical University, No.108, Wansong Road, Ruian, 325200 Wenzhou, Zhejiang Province, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Adult Reconstruction, The Third Affiliated Hospital of Wenzhou Medical University, No.108, Wansong Road, Ruian, 325200 Wenzhou, Zhejiang Province, China.'}, {'ForeName': 'Weihao', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Adult Reconstruction, The Third Affiliated Hospital of Wenzhou Medical University, No.108, Wansong Road, Ruian, 325200 Wenzhou, Zhejiang Province, China.'}, {'ForeName': 'Xiurong', 'Initials': 'X', 'LastName': 'Ke', 'Affiliation': 'Department of Adult Reconstruction, The Third Affiliated Hospital of Wenzhou Medical University, No.108, Wansong Road, Ruian, 325200 Wenzhou, Zhejiang Province, China.'}, {'ForeName': 'Guojing', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Adult Reconstruction, The Third Affiliated Hospital of Wenzhou Medical University, No.108, Wansong Road, Ruian, 325200 Wenzhou, Zhejiang Province, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Adult Reconstruction, The Third Affiliated Hospital of Wenzhou Medical University, No.108, Wansong Road, Ruian, 325200 Wenzhou, Zhejiang Province, China. Electronic address: zhanglei@wmu.edu.cn.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2019.06.018']
1662,30885591,"Use of ribaxamase (SYN-004), a β-lactamase, to prevent Clostridium difficile infection in β-lactam-treated patients: a double-blind, phase 2b, randomised placebo-controlled trial.","BACKGROUND


Infections with Clostridium difficile are a health threat, yet no products are currently licensed for prevention of primary C difficile infections. Intravenous β-lactam antibiotics are considered to confer a high risk of C difficile infection because of their biliary excretion into the gastrointestinal tract and disruption of the gut microbiome. ribaxamase (SYN-004) is an orally administered β-lactamase that was designed to be given with intravenous β-lactam antibiotics to degrade excess antibiotics in the upper gastrointestinal tract before they disrupt the gut microbiome and lead to C difficile infection. We therefore aimed to determine whether administration of ribaxamase could prevent C difficile infection in patients being treated with intravenous ceftriaxone for a lower respiratory tract infection, thereby supporting continued clinical development.
METHODS


In this parallel-group, double-blind, multicentre, phase 2b, randomised placebo-controlled trial, we recruited patients who had been admitted to a hospital with a lower respiratory tract infection with a pneumonia index score of 90-130 and who were expected to be treated with ceftriaxone for at least 5 days. Patients were recruited from 54 clinical sites in the USA, Canada, Bulgaria, Hungary, Poland, Romania, and Serbia. We randomly assigned patients older than 50 years to groups (1:1) in blocks of four by use of an interactive web portal; these groups were assigned to receive either 150 mg ribaxamase or placebo four times per day during, and for 72 h after, treatment with ceftriaxone. All patients, clinical investigators, study staff, and sponsor personnel were masked to the study drug assignments. The primary endpoint was the incidence of C difficile infection, as diagnosed by the local laboratory, in patients who received at least one treatment dose, and this outcome was assessed during treatment and for 4 weeks after treatment. This study is registered with ClinicalTrials.gov, number NCT02563106.
FINDINGS


Between Nov 16, 2015, and Nov 10, 2016, we screened 433 patients for inclusion in the study. Of these patients, 20 (5%) patients were excluded from the study (16 [4%] patients did not meet inclusion criteria; four [1%] patients because of dosing restrictions). We enrolled and randomly assigned 413 patients to groups, of whom 207 patients were assigned to receive ceftriaxone plus ribaxamase and 206 patients were assigned to receive ceftriaxone plus placebo. However, one (<1%) patient in the ribaxamase group withdrew consent and was not treated with ribaxamase. During the study and within the 4 weeks after antibiotic treatment, two (1·0%) patients in the ribaxamase group and seven (3·4%) patients in the placebo group were diagnosed with an infection with C difficile (risk reduction 2·4%, 95% CI -0·6 to 5·9; one-sided p=0·045). Adverse events were similar between groups but more deaths were reported in the ribaxamase group (11 deaths vs five deaths in the placebo group). This disparity was due to the higher incidence of deaths attributed to cardiac-associated causes in the ribaxamase group (six deaths vs one death in the placebo group).
INTERPRETATION


In patients treated with intravenous ceftriaxone for lower respiratory tract infections, oral ribaxamase reduced the incidence of C difficile infections compared with placebo. The imbalance in deaths between the groups appeared to be related to the underlying health of the patients. Ribaxamase has the potential to prevent C difficile infection in patients treated with intravenous β-lactam antibiotics, and our findings support continued clinical development of ribaxamase to prevent C difficile infection.
FUNDING


Synthetic Biologics.",2019,Adverse events were similar between groups but more deaths were reported in the ribaxamase group (11 deaths vs five deaths in the placebo group).,"['patients who had been admitted to a hospital with a lower respiratory tract infection with a pneumonia index score of 90-130 and who were expected to be treated with ceftriaxone for at least 5 days', 'patients being treated with intravenous', 'and 206 patients', 'β-lactam-treated patients', 'patients older than 50 years to groups (1:1) in blocks of four by use of an interactive web portal; these groups', 'Of these patients, 20 (5%) patients were excluded from the study (16 [4%] patients did not meet inclusion criteria', '413 patients to groups, of whom 207 patients', 'Patients were recruited from 54 clinical sites in the USA, Canada, Bulgaria, Hungary, Poland, Romania, and Serbia', 'Between Nov 16, 2015, and Nov 10, 2016, we screened 433 patients for inclusion in the study', 'patients treated with intravenous']","['ceftriaxone plus placebo', 'placebo', 'intravenous ceftriaxone', '150 mg ribaxamase or placebo', 'Intravenous β-lactam antibiotics', 'ceftriaxone plus ribaxamase', 'Ribaxamase', 'β-lactam antibiotics', 'ribaxamase (SYN-004', 'ribaxamase', 'ceftriaxone']","['incidence of C difficile infection', 'deaths', 'Adverse events', 'incidence of C difficile infections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0022914', 'cui_str': 'Lactams'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0036708', 'cui_str': 'Serbia'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0022914', 'cui_str': 'Lactams'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C4310096', 'cui_str': 'SYN-004'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",207.0,0.424261,Adverse events were similar between groups but more deaths were reported in the ribaxamase group (11 deaths vs five deaths in the placebo group).,"[{'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Kokai-Kun', 'Affiliation': 'Synthetic Biologics, Rockville, MD, USA. Electronic address: jkokai-kun@syntheticbiologics.com.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Roberts', 'Affiliation': 'Synthetic Biologics, Rockville, MD, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Coughlin', 'Affiliation': 'Synthetic Biologics, Rockville, MD, USA.'}, {'ForeName': 'Chenxiong', 'Initials': 'C', 'LastName': 'Le', 'Affiliation': 'Synthetic Biologics, Rockville, MD, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Whalen', 'Affiliation': 'Synthetic Biologics, Rockville, MD, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Stevenson', 'Affiliation': 'RWS Biomedical Consulting LLC, East Lyme, CT, USA.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Wacher', 'Affiliation': 'Synthetic Biologics, Rockville, MD, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sliman', 'Affiliation': 'Synthetic Biologics, Rockville, MD, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30731-X']
1663,30885685,Transthyretin Stabilization by AG10 in Symptomatic Transthyretin Amyloid Cardiomyopathy.,"BACKGROUND


Transthyretin (TTR) amyloidosis is an underdiagnosed disease caused by destabilization of TTR due to pathogenic mutations or aging. Both pathogenic and protective mutations illuminate mechanisms of disease and potential interventions. AG10 is a selective, oral TTR stabilizer under development for transthyretin amyloidosis cardiomyopathy (ATTR-CM) that mimics a protective TTR mutation.
OBJECTIVES


This randomized, double-blind, placebo-controlled study evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of AG10 in ATTR-CM patients with symptomatic, chronic heart failure.
METHODS


ATTR-CM, New York Heart Association functional class II to III subjects (n = 49, mutant or wild-type) were randomized 1:1:1 to AG10 400 mg, AG10 800 mg, or placebo twice daily for 28 days. Safety and tolerability were assessed by clinical and laboratory criteria. AG10 plasma levels were measured. TTR stability was assessed by changes in serum TTR, and 2 established ex vivo assays (fluorescent probe exclusion and Western blot).
RESULTS


AG10 treatment was well-tolerated, achieved target plasma concentrations and demonstrated near-complete stabilization of TTR. TTR stabilization was more complete and less variable at the higher dose with stabilization by fluorescent probe exclusion of 92 ± 10% (mean ± SD) at trough and 96 ± 9% at peak (both p < 10 -12  vs. placebo). Average serum TTR increased by 36 ± 21% and 51 ± 38% at 400 and 800 mg, respectively (both p < 0.0001 vs. placebo). Baseline serum TTR in treated subjects was below normal in 80% of mutant and 33% of wild-type subjects. AG10 treatment restored serum TTR to the normal range in all subjects.
CONCLUSIONS


AG10 has the potential to be a safe and effective treatment for patients with ATTR-CM. A phase 3 trial is ongoing. (Study of AG10 in Amyloid Cardiomyopathy; NCT03458130).",2019,TTR stabilization was more complete and less variable at the higher dose with stabilization by FPE of 92 ± 10% (mean±SD) at trough and 96 ± 9% at peak (,"['patients with ATTR-CM', 'ATTR-CM, NYHA Class II-III subjects (n = 49, mutant or wild-type', 'ATTR-CM patients with symptomatic, chronic heart failure']","['Transthyretin Stabilization by AG10', 'placebo', 'AG10 400mg, 800mg or placebo']","['TTR stabilization', 'Baseline serum TTR', 'safety, tolerability, pharmacokinetics and pharmacodynamics of AG10', 'tolerated, achieved target plasma concentrations and demonstrated near-complete stabilization of TTR', 'Average serum TTR', 'TTR stability', 'serum TTR', 'serum TTR and two established ex vivo assays', 'AG10 plasma levels', 'Safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0814422,TTR stabilization was more complete and less variable at the higher dose with stabilization by FPE of 92 ± 10% (mean±SD) at trough and 96 ± 9% at peak (,"[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Judge', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Heitner', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, Oregon. Electronic address: heitner@ohsu.edu.'}, {'ForeName': 'Rodney H', 'Initials': 'RH', 'LastName': 'Falk', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Mathew S', 'Initials': 'MS', 'LastName': 'Maurer', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Witteles', 'Affiliation': 'Stanford University Medical Center, Stanford, California.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Grogan', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Van N', 'Initials': 'VN', 'LastName': 'Selby', 'Affiliation': 'University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Yale University Medical Center, New Haven, Connecticut.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Nativi-Nicolau', 'Affiliation': 'University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Jignesh', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Eidos Therapeutics, Inc., San Francisco, California.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Sinha', 'Affiliation': 'Eidos Therapeutics, Inc., San Francisco, California.'}, {'ForeName': 'Cameron W', 'Initials': 'CW', 'LastName': 'Turtle', 'Affiliation': 'Eidos Therapeutics, Inc., San Francisco, California.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Fox', 'Affiliation': 'Eidos Therapeutics, Inc., San Francisco, California.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.03.012']
1664,30892292,Comparison of the Color Appearance of Peri-implant Soft Tissue with Natural Gingiva Using Anodized Pink-Neck Implants and Pink Abutments: A Prospective Clinical Trial.,"PURPOSE


The aim of this study was to assess the visual effects of pink-neck implants and pink abutments with respect to the color of natural gingiva. The distribution pattern and magnitude of CIELAB color difference coordinates were studied.
MATERIALS AND METHODS


Forty subjects with a tooth in the maxillary esthetic zone deemed hopeless were recruited. Patients were randomized to either a conventional gray implant or a pink-neck implant. The hopeless tooth was removed and patients received an immediate implant along with an immediate customized provisional prosthesis. The provisional was maintained for 3 months to allow for complete healing of the implants. Two identical CAD/CAM titanium abutments only differing in color (gray and pink) were fabricated along with an all-ceramic zirconia crown. The gray abutment was delivered first with a zirconia crown, and it was replaced with the pink abutment 3 weeks later. Three weeks after insertion of each abutment with the zirconia crown, a spectrophotometer was used to collect the color of the peri-implant mucosa and natural gingiva, so the difference between the two sites could be calculated (ΔL* [difference in lightness], Δa* [difference in green-red axis], Δb* [difference in blue-yellow axis]). The natural gingiva measured was the gingiva of a contralateral or adjacent unrestored tooth. The effect of implant color and abutment on the color difference between peri-implant mucosa and natural gingiva was investigated with a linear regression model using a generalized estimating equation (GEE) approach.
RESULTS


Raw data demonstrated statistically insignificant smaller ΔL*, Δa*, Δb* between peri-implant soft tissue and natural gingiva when the implant was pink versus gray. Further, there were statistically insignificant smaller ΔL* and Δb* between peri-implant soft tissue and natural gingiva when the abutment was pink versus gray. Δa* between peri-implant soft tissue and natural gingiva was significantly smaller when using a pink abutment regardless of the implant type (P < .05).
CONCLUSION


Using an anodized pink abutment and/or a pink-neck implant minimizes the color difference observed between the peri-implant mucosa and the natural gingiva in the redness spectrum. These advances in technology assist in helping the peri-implant mucosa appear more natural by minimizing the color variance.",2019,"Δa* between peri-implant soft tissue and natural gingiva was significantly smaller when using a pink abutment regardless of the implant type (P < .05).
",['Forty subjects with a tooth in the maxillary esthetic zone deemed hopeless were recruited'],"['implant color and abutment', 'conventional gray implant or a pink-neck implant', 'pink-neck implants and pink abutments', 'Anodized Pink-Neck Implants and Pink Abutments', 'Color Appearance of Peri-implant Soft Tissue with Natural Gingiva', 'immediate implant along with an immediate customized provisional prosthesis']","['visual effects', 'peri-implant soft tissue and natural gingiva', 'blue-yellow axis']","[{'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1269776', 'cui_str': 'Gray'}, {'cui': 'C0332585', 'cui_str': 'Pink color (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0017562', 'cui_str': 'Gums'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0017562', 'cui_str': 'Gums'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0221205', 'cui_str': 'Yellow color (qualifier value)'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}]",40.0,0.0364072,"Δa* between peri-implant soft tissue and natural gingiva was significantly smaller when using a pink abutment regardless of the implant type (P < .05).
","[{'ForeName': 'Mindy S', 'Initials': 'MS', 'LastName': 'Gil', 'Affiliation': ''}, {'ForeName': 'Shigemi', 'Initials': 'S', 'LastName': 'Ishikawa-Nagai', 'Affiliation': ''}, {'ForeName': 'Hawazin W', 'Initials': 'HW', 'LastName': 'Elani', 'Affiliation': ''}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Da Silva', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Tarnow', 'Affiliation': ''}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schulze-Späte', 'Affiliation': ''}, {'ForeName': 'Cleber', 'Initials': 'C', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Nurit', 'Initials': 'N', 'LastName': 'Bittner', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.6318']
1665,30850240,Inflammatory parameters associated with systemic reactogenicity following vaccination with adjuvanted hepatitis B vaccines in humans.,"BACKGROUND


Adjuvants like AS01 B  increase the immunogenicity of vaccines and generally cause increased transient reactogenicity compared with Alum. A phase II randomized trial was conducted to characterize the response to AS01 B  and Alum adjuvanted vaccines. A post-hoc analysis was performed to examine the associations between reactogenicity and innate immune parameters.
METHODS


The trial involved 60 hepatitis B-naïve adults aged 18-45 years randomized 1:1 to receive either two doses of HBsAg-AS01 B  on Day (D)0 and D30, or three doses of HBsAg-Alum on D0, D30, D180. Prior to vaccination, all subjects received placebo injection in order to differentiate the impact of injection process and the vaccination. Main outcomes included reactogenicity symptoms, vital signs, blood cytokines, biochemical and hematological parameters after vaccination. Associations were explored using linear regression.
FINDINGS


The vaccine with AS01 B  induced higher HBsAg-specific antibody levels than Alum. Local and systemic symptoms were more frequent in individuals who received HBsAg AS01 B /Alum vaccine or placebo, but were mild and short-lived. Blood levels of C-reactive protein (CRP), bilirubin, leukocyte, monocyte and neutrophil counts increased rapidly and transiently after AS01 B  but not after Alum or placebo. Lymphocyte counts decreased in the AS01 B  group and lactate dehydrogenase levels decreased after Alum. Modelling revealed associations between systemic symptoms and increased levels of CRP and IL-6 after the first HBsAg-AS01 B  or HBsAg-Alum immunization. Following the second vaccine dose, CRP, IL-6, IP-10, IFN-γ, MIP-1β and MCP-2 were identified as key parameters associated with systemic symptoms. These observations were confirmed using an independent data set extracted from a previous study of the immune response to HBsAg-adjuvanted vaccines (NCT00805389).
CONCLUSIONS


IL-6 and IFN-γ signals were associated with systemic reactogenicity following administration of AS01 B -adjuvanted vaccine. These signals were similar to those previously associated with antibody and T-cell responses induced by HBsAg-adjuvanted vaccines, suggesting that similar innate immune signals may underlie adjuvant reactogenicity and immunogenicity.
TRIAL REGISTRATION


www.clinicaltrials.gov NCT01777295.",2019,"Following the second vaccine dose, CRP, IL-6, IP-10, IFN-γ, MIP-1β and MCP-2 were identified as key parameters associated with systemic symptoms.","['humans', '60 hepatitis B-naïve adults aged 18-45\u202fyears']","['HBsAg-AS01 B  on Day (D)0 and D30, or three doses of HBsAg-Alum on D0, D30, D180', 'placebo', 'placebo injection', 'HBsAg AS01 B /Alum vaccine or placebo', 'vaccination with adjuvanted hepatitis B vaccines']","['Blood levels of C-reactive protein (CRP), bilirubin, leukocyte, monocyte and neutrophil counts', 'systemic reactogenicity', 'lactate dehydrogenase levels', 'levels of CRP and IL-6', 'CRP, IL-6, IP-10, IFN-γ, MIP-1β and MCP-2', 'reactogenicity and innate immune parameters', 'higher HBsAg-specific antibody levels', 'Lymphocyte counts', 'Local and systemic symptoms', 'reactogenicity symptoms, vital signs, blood cytokines, biochemical and hematological parameters']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0137988', 'cui_str': 'alum'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}]","[{'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C1277793', 'cui_str': 'Specific antibody measurement'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518766'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}]",60.0,0.277281,"Following the second vaccine dose, CRP, IL-6, IP-10, IFN-γ, MIP-1β and MCP-2 were identified as key parameters associated with systemic symptoms.","[{'ForeName': 'Wivine', 'Initials': 'W', 'LastName': 'Burny', 'Affiliation': 'GSK, Rixensart/Wavre, Belgium. Electronic address: Wivine.Burny@GSK.com.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Marchant', 'Affiliation': 'Institute for Medical Immunology, Université libre de Bruxelles, Charleroi, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hervé', 'Affiliation': 'GSK, Rixensart/Wavre, Belgium.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Callegaro', 'Affiliation': 'GSK, Rixensart/Wavre, Belgium.'}, {'ForeName': 'Magalie', 'Initials': 'M', 'LastName': 'Caubet', 'Affiliation': 'GSK, Rixensart/Wavre, Belgium.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Fissette', 'Affiliation': 'GSK, Rixensart/Wavre, Belgium.'}, {'ForeName': 'Lien', 'Initials': 'L', 'LastName': 'Gheyle', 'Affiliation': 'SGS Life Science Services, Antwerp, Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Legrand', 'Affiliation': 'Institute of Statistics, Biostatistics and Actuarial Sciences (ISBA), Université Catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Cheikh', 'Initials': 'C', 'LastName': 'Ndour', 'Affiliation': 'Institute of Statistics, Biostatistics and Actuarial Sciences (ISBA), Université Catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Tavares Da Silva', 'Affiliation': 'GSK, Rixensart/Wavre, Belgium.'}, {'ForeName': 'Robbert', 'Initials': 'R', 'LastName': 'van der Most', 'Affiliation': 'GSK, Rixensart/Wavre, Belgium.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Willems', 'Affiliation': 'Institute for Medical Immunology, Université libre de Bruxelles, Charleroi, Belgium.'}, {'ForeName': 'Arnaud M', 'Initials': 'AM', 'LastName': 'Didierlaurent', 'Affiliation': 'GSK, Rixensart/Wavre, Belgium.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yarzabal', 'Affiliation': 'GSK, Rixensart/Wavre, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2019.02.015']
1666,31709903,Post-Sexual Assault Mental Health: A Randomized Clinical Trial of a Video-Based Intervention.,"The current study assessed the efficacy of a brief video intervention (Prevention of Post-Rape Stress [PPRS]) delivered in the emergency department to recent sexual assault (SA) victims. PPRS was compared to treatment as usual (TAU) and an active control condition (Pleasant Imagery and Relaxation Instruction [PIRI]). Primary outcomes were posttraumatic stress disorder (PTSD) symptoms and perceived present control. Prior SA was examined as a moderator of treatment effects. Women ( n  = 233; aged 15 years and older; 59.70% identified as a racial or ethnic minority) who received a post-SA medical forensic exam participated in the study (NCT01430624). Participants were randomized to watch the PPRS video ( n  = 77), the PIRI video ( n  = 77), or receive TAU ( n  = 79). Participants completed measures of PTSD symptoms and perceived present control 1.5-, 3-, and 6-months post-SA. An interaction between condition and prior SA was found on PTSD symptom frequency and on perceived present control. Among women with a prior SA, women in the PPRS versus TAU condition reported less frequent PTSD symptoms 6-months post-SA. Those in the PPRS condition had lower perceived present control than those in the TAU condition among those with no prior SA 3-months post-SA. However, at 6-months post-SA, among women with a prior SA, women in the PPRS reported higher perceived present control than those in TAU. These findings partially replicate a prior study in which PPRS was found to be beneficial in mitigating the development of PTSD symptoms, but only for women with a prior SA.",2019,Those in the PPRS condition had lower perceived present control than those in the TAU condition among those with no prior SA 3-months post-SA.,"['emergency department to recent sexual assault (SA) victims', 'Women ( n  = 233; aged 15 years and older; 59.70% identified as a racial or ethnic minority) who received a post-SA medical forensic exam participated in the study (NCT01430624', 'Post-Sexual Assault Mental Health']","['TAU', 'Video-Based Intervention', 'PPRS video', 'PPRS', 'video intervention (Prevention of Post-Rape Stress [PPRS', 'PIRI video']","['posttraumatic stress disorder (PTSD) symptoms and perceived present control', 'PTSD symptom frequency', 'PTSD symptoms']","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0277730', 'cui_str': 'Victim of sexual aggression (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault (event)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0330502', 'cui_str': 'Brassica napus'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0436350', 'cui_str': 'Symptom frequency (observable entity)'}]",,0.018396,Those in the PPRS condition had lower perceived present control than those in the TAU condition among those with no prior SA 3-months post-SA.,"[{'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Gilmore', 'Affiliation': 'Georgia State University, Atlanta, GA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Walsh', 'Affiliation': 'Yeshiva University, New York, NY, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Frazier', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Meredith', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ledray', 'Affiliation': 'SANE-SART Resource Service, Minneapolis, MN, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'University of Tulsa, OK, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Acierno', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Ruggiero', 'Affiliation': 'Georgia State University, Atlanta, GA, USA.'}, {'ForeName': 'Dean G', 'Initials': 'DG', 'LastName': 'Kilpatrick', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Jaffe', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Heidi S', 'Initials': 'HS', 'LastName': 'Resnick', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}]",Journal of interpersonal violence,['10.1177/0886260519884674']
1667,30792154,"Use of metformin to treat pregnant women with polycystic ovary syndrome (PregMet2): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Women with polycystic ovary syndrome (PCOS) have an increased risk of pregnancy complications. Epi-analysis of two previous randomised controlled trials that compared metformin with placebo during pregnancy in women with PCOS showed a significant reduction in late miscarriages and preterm births in the metformin group. The aim of this third randomised trial (PregMet2) was to test the hypothesis that metformin prevents late miscarriage and preterm birth in women with PCOS.
METHODS


PregMet2 was a randomised, placebo-controlled, double-blind, multicentre trial done at 14 hospitals in Norway, Sweden, and Iceland. Singleton pregnant women with PCOS aged 18-45 years were eligible for inclusion. After receiving information about the study at their first antenatal visit or from the internet, women signed up individually to participate in the study. Participants were randomly assigned (1:1) to receive metformin or placebo by computer-generated random numbers. Randomisation was in blocks of ten for each country and centre; the first block had a random size between one and ten to assure masking. Participants were assigned to receive oral metformin 500 mg twice daily or placebo during the first week of treatment, which increased to 1000 mg twice daily or placebo from week 2 until delivery. Placebo tablets and metformin tablets were identical and participants and study personnel were masked to treatment allocation. The primary outcome was the composite incidence of late miscarriage (between week 13 and week 22 and 6 days) and preterm birth (between week 23 and week 36 and 6 days), analysed in the intention-to-treat population. Secondary endpoints included the incidence of gestational diabetes, preeclampsia, pregnancy-induced hypertension, and admission of the neonate to the neonatal intensive care unit. We also did a post-hoc individual participant data analysis of pregnancy outcomes, pooling data from the two previous trials with the present study. The study was registered with ClinicalTrials.gov, number NCT01587378, and EudraCT, number 2011-002203-15.
FINDINGS


The study took place between Oct 19, 2012, and Sept 1, 2017. We randomly assigned 487 women to metformin (n=244) or placebo (n=243). In the intention-to-treat analysis, our composite primary outcome of late miscarriage and preterm birth occurred in 12 (5%) of 238 women in the metformin group and 23 (10%) of 240 women in the placebo group (odds ratio [OR] 0·50, 95% CI 0·22-1·08; p=0·08). We found no significant differences for our secondary endpoints, including incidence of gestational diabetes (60 [25%] of 238 women in the metformin group vs 57 [24%] of 240 women in the placebo group; OR 1·09, 95% CI 0·69-1·66; p=0·75). We noted no substantial between-group differences in serious adverse events in either mothers or offspring, and no serious adverse events were considered drug-related by principal investigators. In the post-hoc pooled analysis of individual participant data from the present trial and two previous trials, 18 (5%) of 397 women had late miscarriage or preterm delivery in the metformin group compared with 40 (10%) of 399 women in the placebo group (OR 0·43, 95% CI 0·23-0·79; p=0·004).
INTERPRETATION


In pregnant women with PCOS, metformin treatment from the late first trimester until delivery might reduce the risk of late miscarriage and preterm birth, but does not prevent gestational diabetes.
FUNDING


Research Council of Norway, Novo Nordisk Foundation, St Olav's University Hospital, and Norwegian University of Science and Technology.",2019,"We noted no substantial between-group differences in serious adverse events in either mothers or offspring, and no serious adverse events were considered drug-related by principal investigators.","['women with PCOS', 'Women with polycystic ovary syndrome (PCOS', '487 women to', 'pregnant women with polycystic ovary syndrome (PregMet2', 'pregnant women with PCOS', '14 hospitals in Norway, Sweden, and Iceland', 'Singleton pregnant women with PCOS aged 18-45 years were eligible for inclusion']","['placebo', 'metformin', 'metformin or placebo', 'metformin with placebo', 'oral metformin 500 mg twice daily or placebo', 'Placebo tablets and metformin tablets']","['late miscarriages and preterm births', 'composite incidence of late miscarriage', 'incidence of gestational diabetes, preeclampsia, pregnancy-induced hypertension, and admission of the neonate to the neonatal intensive care unit', 'incidence of gestational diabetes', 'preterm birth', 'risk of late miscarriage and preterm birth', 'late miscarriage or preterm delivery', 'serious adverse events', 'late miscarriage and preterm birth']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0020750', 'cui_str': 'Iceland'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C4324509', 'cui_str': 'Late miscarriage'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0852036', 'cui_str': 'Hypertension, Pregnancy-Induced'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",487.0,0.700303,"We noted no substantial between-group differences in serious adverse events in either mothers or offspring, and no serious adverse events were considered drug-related by principal investigators.","[{'ForeName': 'Tone S', 'Initials': 'TS', 'LastName': 'Løvvik', 'Affiliation': ""Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway; Department of Gynaecology and Obstetrics, St Olav's University Hospital, Trondheim, Norway. Electronic address: tone.s.lovvik@ntnu.no.""}, {'ForeName': 'Sven M', 'Initials': 'SM', 'LastName': 'Carlsen', 'Affiliation': ""Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway; Department of Endocrinology, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Berglind', 'Initials': 'B', 'LastName': 'Steffensen', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bixo', 'Affiliation': 'Department of Clinical Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gómez-Real', 'Affiliation': 'Department of Obstetrics and Gynaecology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lønnebotn', 'Affiliation': 'Department of Obstetrics and Gynaecology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Kristin V', 'Initials': 'KV', 'LastName': 'Hestvold', 'Affiliation': ""Women's Clinic, Vestre Viken Hospital Trust, Drammen, Norway.""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Zabielska', 'Affiliation': ""Women's Clinic, Vestfold Hospital Trust, Tønsberg, Norway.""}, {'ForeName': 'Angelica L', 'Initials': 'AL', 'LastName': 'Hirschberg', 'Affiliation': ""Department of Gynecology and Reproductive Medicine, Karolinska University Hospital, Stockholm, Sweden; Department of Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.""}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Trouva', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden; Centre for Clinical Research Sörmland, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Thorarinsdottir', 'Affiliation': ""Women's Clinic, Telemark Hospital Trust, Skien, Norway.""}, {'ForeName': 'Sissel', 'Initials': 'S', 'LastName': 'Hjelle', 'Affiliation': ""Women's Clinic, Ålesund Hospital, Ålesund, Norway.""}, {'ForeName': 'Ann Hilde', 'Initials': 'AH', 'LastName': 'Berg', 'Affiliation': ""Women's Clinic, Innlandet Hospital Trust, Lillehammer, Norway.""}, {'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Andræ', 'Affiliation': ""Women's Clinic, Nordlands Hospital Trust, Bodø, Norway.""}, {'ForeName': 'Inger S', 'Initials': 'IS', 'LastName': 'Poromaa', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Mohlin', 'Affiliation': 'Department of Clinical Sciences, Umeå University, Umeå, Sweden; Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Underdal', 'Affiliation': ""Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway; Department of Gynaecology and Obstetrics, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Vanky', 'Affiliation': ""Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway; Department of Gynaecology and Obstetrics, St Olav's University Hospital, Trondheim, Norway.""}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30002-6']
1668,31536809,"A religiously-tailored, multilevel intervention in African American churches to increase HIV testing: Rationale and design of the Taking It to the Pews cluster randomized trial.","HIV continues to disproportionately impact African American (AA) communities. Due to delayed HIV diagnosis, AAs tend to enter HIV treatment at advanced stages. There is great need for increased access to regular HIV testing and linkage to care services for AAs. AA faith institutions are highly influential and have potential to increase the reach of HIV testing in AA communities. However, well-controlled full-scale trials have not been conducted in the AA church context. We describe the rationale and design of a 2-arm cluster randomized trial to test a religiously-tailored HIV testing intervention (Taking It to the Pews [TIPS]) against a standard information arm on HIV testing rates among AA church members and community members they serve. Using a community-engaged approach, TIPS intervention components are delivered by trained church leaders via existing multilevel church outlets using religiously-tailored HIV Tool Kit materials and activities (e.g., sermons, responsive readings, video/print testimonials, HIV educational games, text messages) to encourage testing. Church-based HIV testing events and linkage to care services are conducted by health agency partners. Control churches receive standard, non-tailored HIV information via multilevel church outlets. Secondarily, HIV risk/protective behaviors and process measures on feasibility, fidelity, and dose/exposure are assessed. This novel study is the first to fully test an HIV testing intervention in AA churches - a setting with great reach and influence in AA communities. It could provide a faith-community engagement model for delivering scalable, wide-reaching HIV prevention interventions by supporting AA faith leaders with religiously-appropriate HIV toolkits and health agency partners.",2019,There is great need for increased access to regular HIV testing and linkage to care (LTC) services for AAs.,"['African American churches', 'AA churches - a setting with great reach and influence in AA communities']","['Control churches receive standard HIV education information', 'religiously-tailored HIV testing intervention (Taking It to the Pews [TIPS']","['feasibility, fidelity, and dose/exposure', 'HIV testing rates']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1321876', 'cui_str': 'Human immunodeficiency virus test (procedure)'}]",,0.0373933,There is great need for increased access to regular HIV testing and linkage to care (LTC) services for AAs.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Berkley-Patton', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, United States of America. Electronic address: berkleypattonj@umkc.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bowe Thompson', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City & Schools of Medicine and Pharmacy, University of Missouri-Kansas City, Kansas City, MO, United States of America.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Children's Mercy Kansas City & Department of Pediatrics, University of Missouri, Kansas City, MO, United States of America.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Berman', 'Affiliation': 'The Institute for Community Research, Hartford, CT, United States of America.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bradley-Ewing', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City, Kansas City, MO, United States of America.""}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Derose', 'Affiliation': 'Pardee RAND Graduate School, RAND Corporation, Santa Monica, CA, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Center for Health Communication Research, School of Public Health, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Allsworth', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, United States of America.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Simon', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105848']
1669,31383366,Insulin Glargine U100 Improved Glycemic Control and Reduced Nocturnal Hypoglycemia in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease Stages 3 and 4.,"PURPOSE


Glycemic control in patients with chronic kidney disease (CKD) is particularly hard to achieve because of a slower insulin degradation by the kidney. It might modify the long-acting insulin analogue pharmacokinetics, increasing its time-action and the risk of hypoglycemia. However, because this insulin has no peak action, it might be a more tolerable approach to patients with CKD. This hypothesis remains to be tested, because no study has thus far examined the efficacy and safety profile of long-acting basal analogues in patients with significant loss of renal function. The purpose of this study was to compare the glycemic response to treatment with glargine U100 or neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes mellitus (T2DM) and CKD stages 3 and 4.
METHODS


Thirty-four patients were randomly assigned to glargine U100 or NPH insulin after a 2-way crossover open-label design. The primary end point was the difference in glycosylated hemoglobin (HbA 1c ) and in the number of hypoglycemic events between weeks 1 and 24, whereas secondary end points included changes in glycemic patterns, weight and body mass index, and total daily dose of insulin. HbA 1c  was determined by ion-exchange HPLC, and hypoglycemia was defined as glucose concentration of 54 mg/dL (3.0 mmol/L) detected by self-monitoring of plasma glucose or continuous glucose monitoring.
FINDINGS


After 24 weeks, mean HbA 1c  decreased on glargine U100 treatment (-0.91%; P < 0.001), but this benefit was not observed for NPH (0.23%; P = 0.93). Moreover, incidence of nocturnal hypoglycemia was 3 times lower with glargine than with NPH insulin (P = 0.047).
IMPLICATIONS


Our results found that insulin glargine U100 could be effective, once it improved glycemic control, reducing HbA 1c  with fewer nocturnal hypoglycemia episodes compared with NPH insulin in this population. These clinical benefits justify the use of basal insulin analogues, despite their high cost to treat patients with T2DM and CKD stages 3 and 4. Clinical Trials identifier: NCT02451917.",2019,"After 24 weeks, mean HbA 1c  decreased on glargine U100 treatment (-0.91%; P < 0.001), but this benefit was not observed for NPH (0.23%; P = 0.93).","['patients with CKD', 'patients with type 2 diabetes mellitus (T2DM) and CKD stages 3 and 4', 'Thirty-four patients', 'patients with significant loss of renal function', 'patients with chronic kidney disease (CKD', 'Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease Stages 3 and 4']","['Insulin Glargine', 'glargine', 'glargine U100 or neutral protamine Hagedorn (NPH) insulin', 'glargine U100 or NPH insulin', 'insulin glargine']","['mean HbA 1c  decreased on glargine U100 treatment', 'glycemic response', 'glycemic patterns, weight and body mass index, and total daily dose of insulin', 'glycosylated hemoglobin (HbA 1c ) and in the number of hypoglycemic events', 'Nocturnal Hypoglycemia', 'incidence of nocturnal hypoglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2316787', 'cui_str': 'CKD stage 3'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0021658', 'cui_str': 'insulin, isophane'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",34.0,0.0142166,"After 24 weeks, mean HbA 1c  decreased on glargine U100 treatment (-0.91%; P < 0.001), but this benefit was not observed for NPH (0.23%; P = 0.93).","[{'ForeName': 'Carolina C', 'Initials': 'CC', 'LastName': 'Betônico', 'Affiliation': 'Endocrinology Division, Internal Medicine Department, Hospital das Clinicas Faculdade de Medicina, Universidade São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Silvia Maria O', 'Initials': 'SMO', 'LastName': 'Titan', 'Affiliation': 'Nephrology Division, Internal Medicine Department, Hospital das Clinicas Faculdade de Medicina, Universidade São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Aécio', 'Initials': 'A', 'LastName': 'Lira', 'Affiliation': 'Endocrinology Division, Internal Medicine Department, Hospital das Clinicas Faculdade de Medicina, Universidade São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Tatiana S', 'Initials': 'TS', 'LastName': 'Pelaes', 'Affiliation': 'Endocrinology Division, Internal Medicine Department, Hospital das Clinicas Faculdade de Medicina, Universidade São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Lúcia C', 'Initials': 'MLC', 'LastName': 'Correa-Giannella', 'Affiliation': 'Laboratory of Carbohydrates and Radioimmunoassays (LIM-18), Discipline of Endocrinology and Metabolism, Faculdade de Medicina, Universidade São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Nery', 'Affiliation': 'Endocrinology Division, Internal Medicine Department, Hospital das Clinicas Faculdade de Medicina, Universidade São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Queiroz', 'Affiliation': 'Endocrinology Division, Internal Medicine Department, Hospital das Clinicas Faculdade de Medicina, Universidade São Paulo, São Paulo, Brazil. Electronic address: marciasqz@gmail.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.07.011']
1670,31515006,An informative nursing intervention for families of patients admitted to the intensive care unit regarding the satisfaction of their needs: The INFOUCI study.,"AIM


To evaluate whether an informative intervention by nursing professionals through Short Message Service (SMS) improved patients' family members' satisfaction with the intensive care experience.
METHODS/DESIGN


This was an exploratory, two-armed, randomised, non-pharmacological, prospective study. The intervention consisted of providing information to the contact persons of patients admitted to the ICU of the University Hospital La Princesa (Madrid, Spain) through SMS based on the patient's nursing assessment. Nursing diagnoses established by NANDA and based on the Virginia Henderson model were used as a reference. The main result was the satisfaction levels of the contacts of patients admitted to the intensive care unit, which was evaluated with the Critical Care Family Needs Inventory.
RESULTS


The total score on the Critical Care Family Needs Inventory was significantly better in the intervention group (16.6 ± 3.3 vs. 19.1 ± 4.7; p = 0.012) compared with the control group. All participants included in the intervention considered it useful to some degree. Even when the contact person received negative information, there was no demand for information outside established hours, which was included as a possible adverse effect of the intervention.
CONCLUSION


Support in the form of additional nursing information implied an increase in the satisfaction of the needs perceived by the contact persons of patients admitted to the intensive care unit, together with a better perception of the quality of intensive care unit care and a reassuring and beneficial effect.",2019,The total score on the Critical Care Family Needs Inventory was significantly better in the intervention group (16.6 ± 3.3 vs. 19.1 ± 4.7; p = 0.012) compared with the control group.,"[""patients' family members' satisfaction with the intensive care experience"", ""contact persons of patients admitted to the ICU of the University Hospital La Princesa (Madrid, Spain) through SMS based on the patient's nursing assessment"", 'families of patients admitted to the intensive care unit regarding the satisfaction of their needs']",['informative intervention by nursing professionals through Short Message Service (SMS'],['total score on the Critical Care Family Needs Inventory'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0085559'}, {'cui': 'C0337611', 'cui_str': 'Contact person (person)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028680', 'cui_str': 'Nursing Assessment'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C3178909'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.0295337,The total score on the Critical Care Family Needs Inventory was significantly better in the intervention group (16.6 ± 3.3 vs. 19.1 ± 4.7; p = 0.012) compared with the control group.,"[{'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Rodríguez-Huerta', 'Affiliation': 'Intensive Care Unit, La Princesa University Hospital, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Álvarez-Pol', 'Affiliation': 'Intensive Care Unit, La Princesa University Hospital, Madrid, Spain.'}, {'ForeName': 'Marta Luz', 'Initials': 'ML', 'LastName': 'Fernández-Catalán', 'Affiliation': 'Intensive Care Unit, La Princesa University Hospital, Madrid, Spain.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Fernández-Vadillo', 'Affiliation': 'Intensive Care Unit, La Princesa University Hospital, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martín-Rodríguez', 'Affiliation': 'Hospitalization Unit, Hospital Nuestra Señora de Sonsoles Hospital, Ávila, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Quicios-Dorado', 'Affiliation': 'Intensive Care Unit, La Princesa University Hospital, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Díez-Fernández', 'Affiliation': 'Universidad de Castilla-La Mancha, Faculty of Nursing, Cuenca, Spain; Universidad de Castilla-La Mancha, Social and Health Care Research Center, Cuenca, Spain. Electronic address: ana.diez@uclm.es.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2019.102755']
1671,31409556,Colchicine as a Novel Therapy for Suppressing Chemokine Production in Patients With an Acute Coronary Syndrome: A Pilot Study.,"PURPOSE


Existing literature reports that colchicine inhibits inflammasome activation and downstream inflammatory cytokine production and stabilizes coronary plaque. However, colchicine's effect on chemokines, which orchestrate multiple atheroinflammatory pathways, is unknown.
METHODS


Patients with acute coronary syndrome (ACS) were randomly assigned to colchicine (1.5 mg PO) (n = 12; mean age, 65.2 years) or no treatment (n = 13; mean age, 62.2 years). Blood samples were collected during cardiac catheterization within 24 hours of colchicine administration from the coronary sinus, aortic root, and right atrium. Patients with colchicine-naive stable angina (SAP) (n = 13; mean age, 66.8 years) were additionally sampled. Serum chemokine levels were analyzed with ELISA. In parallel, monocytes from healthy donors were isolated and subjected to colchicine treatment.
FINDINGS


Transcoronary (TC) levels of chemokine ligand 2 (CCL2) and C-X3-C motif chemokine ligand 1 (CX3CL1) were significantly elevated in patients with ACS versus patients with SAP (P < 0.01). TC chemokine ligand 5 (CCL5) levels were not significantly (P = 0.084) elevated in patients with ACS versus patients with SAP. Colchicine treatment markedly reduced TC levels of CCL2, CCL5, and CX3CL1 in patients with ACS (P < 0.05). In vitro colchicine suppressed CCL2 gene expression in stimulated monocytes (P < 0.05). Colchicine treatment reduced the intracellular concentration of all 3 chemokines (P < 0.01) and impaired monocyte chemotaxis (P < 0.05).
IMPLICATIONS


Here, we report for the first time that short-term colchicine therapy significantly reduces the local production of coronary chemokines, in part by attenuating production of these mediators by monocytes. These data provide further evidence of colchicine's beneficial role in patients with ACS.",2019,"Colchicine treatment reduced the intracellular concentration of all 3 chemokines (P < 0.01) and impaired monocyte chemotaxis (P < 0.05).
","['Patients with colchicine-naive stable angina (SAP) (n\xa0=\xa013; mean age, 66.8 years', 'mean age, 65.2 years) or no treatment (n\xa0=\xa013; mean age, 62.2 years', 'Patients With an Acute Coronary Syndrome', 'patients with ACS versus patients with SAP', 'patients with ACS versus patients with SAP (P', 'Patients with acute coronary syndrome (ACS', 'patients with ACS']","['colchicine', 'colchicine (1.5\xa0mg PO', 'Colchicine', 'colchicine therapy']","['TC levels of CCL2, CCL5, and CX3CL1', 'TC chemokine ligand 5 (CCL5) levels', 'Serum chemokine levels', 'monocyte chemotaxis', 'intracellular concentration of all 3 chemokines', 'local production of coronary chemokines', 'Transcoronary (TC) levels of chemokine ligand 2 (CCL2) and C-X3-C motif chemokine ligand 1 (CX3CL1', 'CCL2 gene expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1276855', 'cui_str': 'Monocyte chemotaxis, function (observable entity)'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}]",,0.0202805,"Colchicine treatment reduced the intracellular concentration of all 3 chemokines (P < 0.01) and impaired monocyte chemotaxis (P < 0.05).
","[{'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Tucker', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia. Electronic address: Bradley.tucker@hri.org.au.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Kurup', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia; Sydney Medical School, The University of Sydney, Camperdown, New South Wales, Australia; Department of Cardiology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barraclough', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia; Sydney Medical School, The University of Sydney, Camperdown, New South Wales, Australia; Department of Cardiology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Henriquez', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia.'}, {'ForeName': 'Siân', 'Initials': 'S', 'LastName': 'Cartland', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia; Sydney Medical School, The University of Sydney, Camperdown, New South Wales, Australia; Department of Cardiology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Martínez', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia; Division of Cardiovascular Diseases, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Kavurma', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia; Sydney Medical School, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia; Sydney Medical School, The University of Sydney, Camperdown, New South Wales, Australia; Department of Cardiology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.07.015']
1672,30844672,Preventing adverse information effects on health outcomes: A self-affirmation intervention reduced information-induced cognitive decline in gastrointestinal cancer patients.,"RATIONALE


Nocebo studies show that informing patients about treatment side effects can adversely impact expectancies and symptom reporting.
OBJECTIVE


The current study examined how to inform patients fully about treatment side effects without increasing their occurrence. Extending theoretical assumptions about self-affirmation from the social-psychological to the medical domain, we tested whether allowing cancer patients to self-affirm prior to informing them about potential cognitive decline reduced the occurrence of Adverse Information Effects (AIE) on cognitive problem reporting (CPR) and verbal memory performance.
METHOD


Participants were 90 Dutch and Belgian gastrointestinal cancer patients with and without chemotherapy experience. Patients were randomized across three experimental conditions (information about chemotherapy-related cognitive problems with or without self-affirmation; no-information control) before completing an online questionnaire. Data were collected from May until August 2015. Main dependent variables were CPR and verbal memory performance. Stigma consciousness was included as a moderator.
RESULTS


Informing patients about chemotherapy-related cognitive problems increased CPR and decreased scores on two out of three memory measures. Self-affirmation reduced these AIE. Stigma conscious patients reported more problems in the information than the self-affirmation group.
CONCLUSIONS


Nocebo effects may be reduced by allowing patients the opportunity to restore their self-integrity at the implicit level. Self-affirmation has the potential to reduce AIE in patient populations without withholding relevant information about potential treatment side effects.",2019,"Stigma conscious patients reported more problems in the information than the self-affirmation group.
","['Stigma conscious patients', 'Participants were 90 Dutch and Belgian gastrointestinal cancer patients with and without chemotherapy experience', 'gastrointestinal cancer patients']",['experimental conditions (information about chemotherapy-related cognitive problems with or without self-affirmation; no-information control'],"['cognitive problem reporting (CPR) and verbal memory performance', 'CPR and verbal memory performance', 'health outcomes', 'Stigma consciousness']","[{'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0337797', 'cui_str': 'Belgians (ethnic group)'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]",,0.02306,"Stigma conscious patients reported more problems in the information than the self-affirmation group.
","[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Jacobs', 'Affiliation': 'Radboud University Nijmegen, Centre for Language Studies, Erasmusplein 1, 6525 HT, Nijmegen, the Netherlands; Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands. Electronic address: w.jacobs@let.ru.nl.'}, {'ForeName': 'Sanne B', 'Initials': 'SB', 'LastName': 'Schagen', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; University of Amsterdam, Faculty of Social and Behavioural Sciences, Nieuwe Achtergracht 129, 1018 WS, Amsterdam, the Netherlands. Electronic address: s.schagen@nki.nl.'}, {'ForeName': 'Mart', 'Initials': 'M', 'LastName': 'Thijssen', 'Affiliation': 'Radboud University Nijmegen, Centre for Language Studies, Erasmusplein 1, 6525 HT, Nijmegen, the Netherlands. Electronic address: mart_thijssen@hotmail.com.'}, {'ForeName': 'Enny', 'Initials': 'E', 'LastName': 'Das', 'Affiliation': 'Radboud University Nijmegen, Centre for Language Studies, Erasmusplein 1, 6525 HT, Nijmegen, the Netherlands. Electronic address: h.das@let.ru.nl.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.02.013']
1673,30860654,The effect of a hemodialysis patient education program on fluid control and dietary compliance.,"INTRODUCTION


Some hemodialysis patients may experience problems in completing activities of daily living and adhering to diet and fluid restrictions due to a decrease in self-care power and a loss of competence.
METHODS


The study was conducted with 78 people assigned to the intervention (N = 38) and control groups (N = 40). Data were collected using the sociodemographic characteristics questionnaire, dialysis diet and fluid nonadherence questionnaire (DDFQ), and fluid control in hemodialysis patients scale (FCHPS). The participants in the intervention group were given the ""Nutrition Education Booklet for Dialysis Patients"". The participants in the intervention group were trained through four education sessions across 4 months, and the measurement tools were administered to them. The participants in the control group were interviewed twice, once at the onset of the study and once 2 months later and the measurement tools were administered to them.
FINDINGS


In the intervention group, a decrease was observed in the pre- and postdialysis interdialytic weight gain, ultrafiltration (UF) volume, and blood pressure values of the patients after the training. There was a statistically significant decrease in the mean scores for the frequency and degree of nonadherence to diet restriction, and for the frequency and degree of nonadherence to fluid restriction in the participants in the intervention group compared to the participants in the control group (P < 0.05). There was a statistically significant increase in the mean scores obtained from the FCHPS and its subscales by the participants in the intervention group compared to the participants in the control group (P < 0.05).
CONCLUSION


The training given to the hemodialysis patients positively contributed to their adherence to diet and fluid restrictions. The patients' adherence to diet and fluid restriction increased.",2019,"There was a statistically significant decrease in the mean scores for the frequency and degree of nonadherence to diet restriction, and for the frequency and degree of nonadherence to fluid restriction in the participants in the intervention group compared to the participants in the control group (P < 0.05).",['78 people assigned to the intervention (N = 38) and control groups (N = 40'],"['hemodialysis patient education program', 'Nutrition Education Booklet']","['fluid control and dietary compliance', 'pre- and postdialysis interdialytic weight gain, ultrafiltration (UF) volume, and blood pressure values', 'mean scores', 'sociodemographic characteristics questionnaire, dialysis diet and fluid nonadherence questionnaire (DDFQ), and fluid control in hemodialysis patients scale (FCHPS', 'mean scores for the frequency and degree of nonadherence to diet restriction', 'frequency and degree of nonadherence to fluid restriction']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0336604', 'cui_str': 'Patient scale, device (physical object)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0204700', 'cui_str': 'Fluid restriction (procedure)'}]",78.0,0.0209364,"There was a statistically significant decrease in the mean scores for the frequency and degree of nonadherence to diet restriction, and for the frequency and degree of nonadherence to fluid restriction in the participants in the intervention group compared to the participants in the control group (P < 0.05).","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Başer', 'Affiliation': 'Internal Medicine Nursing, Department of Nursing, Faculty of Health Science, Sivas Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Mukadder', 'Initials': 'M', 'LastName': 'Mollaoğlu', 'Affiliation': 'Internal Medicine Nursing, Department of Nursing, Faculty of Health Science, Sivas Cumhuriyet University, Sivas, Turkey.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12744']
1674,30799266,The James A. Rand Young Investigator's Award: Large Opioid Prescriptions Are Unnecessary After Total Joint Arthroplasty: A Randomized Controlled Trial.,"BACKGROUND


The purpose of this randomized controlled trial is to determine whether the quantity of opioid pills prescribed at discharge is associated with the number of opioid pills consumed or unused by patients after primary hip and knee arthroplasty within 30 days after discharge.
METHODS


A total of 304 opioid-naïve patients were randomized to receive either 30 or 90 5-mg oxycodone immediate-release (OxyIR) pills at discharge. Daily opioid consumption, number of unused pills, and pain scores were calculated for 30 days with a patient-completed medication diary. Statistical analysis involved t-test, rank-sum, chi-squared tests, and multiple linear regression with alpha = 0.05.
RESULTS


Of the 304 patients randomized, 161 patients were randomized to receive 30 pills and 143 to receive 90. In the first 30 days after discharge, the median number of unused pills was 15 in the 30 group vs 73 in the 90 group (P < .001). Within 90 days of discharge, 26.7% of the 30 group and 10.5% of the 90 group requested a refill (P < .001), leading to a mean of 777.1 ± 414.2 morphine equivalents vs 1089.7 ± 536.4 prescribed (P < .0001). There was no difference between groups in mean morphine equivalents consumed. Regression analysis demonstrated that being prescribed 90 OxyIR pills was independently associated with taking more OxyIR pills (P = .028). There was no difference in pain scores within the first 30 days and in patient-reported outcome scores at 6 weeks postoperatively.
CONCLUSION


Prescribing fewer OxyIR pills is associated with a significant reduction in unused opioid pills and decreased opioid consumption with no increase in pain scores and no difference in patient-reported outcomes.
LEVEL OF EVIDENCE


Level I. Randomized controlled trial.",2019,"There was no difference in pain scores within the first 30 days and in patient-reported outcome scores at 6 weeks postoperatively.
","['304 opioid-naïve patients', 'After Total Joint Arthroplasty', '304 patients randomized', '161 patients were randomized to receive 30 pills and 143 to receive 90', 'patients after primary hip and knee arthroplasty within 30 days after discharge']",['oxycodone immediate-release (OxyIR) pills at discharge'],"['opioid consumption', 'median number of unused pills', 'Daily opioid consumption, number of unused pills, and pain scores', 'pain scores']","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",304.0,0.519344,"There was no difference in pain scores within the first 30 days and in patient-reported outcome scores at 6 weeks postoperatively.
","[{'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Hannon', 'Affiliation': 'Adult Reconstruction Division, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Tyler E', 'Initials': 'TE', 'LastName': 'Calkins', 'Affiliation': 'Adult Reconstruction Division, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Adult Reconstruction Division, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Culvern', 'Affiliation': 'Adult Reconstruction Division, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Darrith', 'Affiliation': 'Adult Reconstruction Division, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Nam', 'Affiliation': 'Adult Reconstruction Division, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Tad L', 'Initials': 'TL', 'LastName': 'Gerlinger', 'Affiliation': 'Adult Reconstruction Division, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Asokumar', 'Initials': 'A', 'LastName': 'Buvanendran', 'Affiliation': 'Department of Anesthesiology, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Della Valle', 'Affiliation': 'Adult Reconstruction Division, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.01.065']
1675,30860588,Effect of Parathyroidectomy on Cardiovascular Risk Factors in Primary Hyperparathyroidism: A Randomized Clinical Trial.,"CONTEXT


It remains unclear whether risk of cardiovascular diseases is increased in patients with mild (<1.45 mmol/L) to moderate (≥1.45 to 1.60 mmol/L) primary hyperparathyroidism (PHPT).
OBJECTIVE


We aimed to determine the short-term effect of parathyroidectomy (PTX) on arterial stiffness, cholesterol levels, and blood pressure (BP).
DESIGN


This study was a clinical trial randomly allocating patients to either PTX or a control group (no surgery). Follow-up was performed 3 months after surgery in the PTX group and 3 months after baseline in the control group.
SETTING


University hospital.
PARTICIPANTS


We recruited 79 patients with PHPT; 69 participants completed the study.
MAIN OUTCOMES


Office and ambulatory 24-hour BP, pulse wave velocity (PWV), augmentation index, and fasting plasma cholesterol levels.
RESULTS


At baseline, participants had a median level of ionized calcium of 1.41 mmol/L (range, 1.33 to 1.60 mmol/L) and PTH of 10.4 pmol/L (4.5 to 30.4 pmol/L). Median age was 64 years (range, 18 to 81) and 72% were females. Following PTX, plasma total cholesterol levels decreased significantly compared with the controls (P = 0.04). Changes in PWV, augmentation index, and ambulatory 24-hour BP did not differ between groups, except for an increase in ambulatory diastolic BP following PTX. However, in patients with baseline levels of ionized calcium ≥1.45 mmol/L, PWV decreased significantly in response to PTX compared with the control group (P = 0.03).
CONCLUSION


PTX may decrease risk of cardiovascular diseases in PHPT by lowering total cholesterol levels, although ambulatory diastolic BP increases in response to surgery. Patients with moderate to severe hypercalcemia may benefit from PTX by a decrease in PWV.",2019,"Following PTX, plasma total cholesterol levels decreased significantly compared with the controls (P = 0.04).","['Patients with moderate to severe hypercalcemia', 'University hospital', 'patients with mild (<1.45 mmol/L) to moderate (≥1.45 to 1.60 mmol/L) primary hyperparathyroidism (PHPT', 'Primary Hyperparathyroidism', 'or a control group (no surgery', 'We recruited 79 patients with PHPT; 69 participants completed the study', 'Median age was 64 years (range, 18 to 81) and 72% were females']","['parathyroidectomy (PTX', 'Parathyroidectomy', 'PTX']","['ambulatory diastolic BP', 'PWV', 'Office and ambulatory 24-hour BP, pulse wave velocity (PWV), augmentation index, and fasting plasma cholesterol levels', 'arterial stiffness, cholesterol levels, and blood pressure (BP', 'plasma total cholesterol levels', 'median level of ionized calcium', 'Cardiovascular Risk Factors', 'Changes in PWV, augmentation index, and ambulatory 24-hour BP', 'total cholesterol levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C4517505', 'cui_str': '1.45'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0221002', 'cui_str': 'Hyperparathyroidism, Primary'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1272107', 'cui_str': 'Plasma total cholesterol level'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",79.0,0.0640341,"Following PTX, plasma total cholesterol levels decreased significantly compared with the controls (P = 0.04).","[{'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Ejlsmark-Svensson', 'Affiliation': 'Department of Clinical Medicine, Aarhus University and Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rolighed', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rejnmark', 'Affiliation': 'Department of Clinical Medicine, Aarhus University and Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-02456']
1676,30872387,Electronic health record-based clinical decision support alert for severe sepsis: a randomised evaluation.,"BACKGROUND


Sepsis remains the top cause of morbidity and mortality of hospitalised patients despite concerted efforts. Clinical decision support for sepsis has shown mixed results reflecting heterogeneous populations, methodologies and interventions.
OBJECTIVES


To determine whether the addition of a real-time electronic health record (EHR)-based clinical decision support alert improves adherence to treatment guidelines and clinical outcomes in hospitalised patients with suspected severe sepsis.
DESIGN


Patient-level randomisation, single blinded.
SETTING


Medical and surgical inpatient units of an academic, tertiary care medical centre.
PATIENTS


1123 adults over the age of 18 admitted to inpatient wards (intensive care units (ICU) excluded) at an academic teaching hospital between November 2014 and March 2015.
INTERVENTIONS


Patients were randomised to either usual care or the addition of an EHR-generated alert in response to a set of modified severe sepsis criteria that included vital signs, laboratory values and physician orders.
MEASUREMENTS AND MAIN RESULTS


There was no significant difference between the intervention and control groups in primary outcome of the percentage of patients with new antibiotic orders at 3 hours after the alert (35% vs 37%, p=0.53). There was no difference in secondary outcomes of in-hospital mortality at 30 days, length of stay greater than 72 hours, rate of transfer to ICU within 48 hours of alert, or proportion of patients receiving at least 30 mL/kg of intravenous fluids.
CONCLUSIONS


An EHR-based severe sepsis alert did not result in a statistically significant improvement in several sepsis treatment performance measures.",2019,"There was no difference in secondary outcomes of in-hospital mortality at 30 days, length of stay greater than 72 hours, rate of transfer to ICU within 48 hours of alert, or proportion of patients receiving at least 30 mL/kg of intravenous fluids.
","['hospitalised patients with suspected severe sepsis', '1123 adults over the age of 18 admitted to inpatient wards (intensive care units (ICU) excluded) at an academic teaching hospital between November 2014 and March 2015', 'Medical and surgical inpatient units of an academic, tertiary care medical centre', 'severe sepsis']","['usual care or the addition of an EHR-generated alert in response', 'Electronic health record-based clinical decision support alert']","['percentage of patients with new antibiotic orders', 'length of stay greater than 72\u2009hours, rate of transfer to ICU', 'hospital mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4042765', 'cui_str': 'Clinical Decision Support'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C1275717', 'cui_str': 'Transfer to ICU'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}]",,0.331398,"There was no difference in secondary outcomes of in-hospital mortality at 30 days, length of stay greater than 72 hours, rate of transfer to ICU within 48 hours of alert, or proportion of patients receiving at least 30 mL/kg of intravenous fluids.
","[{'ForeName': 'Norman Lance', 'Initials': 'NL', 'LastName': 'Downing', 'Affiliation': 'Department of Medicine - Biomedical Informatics Research, Hospital Medicine, and Primary Care and Population Health, Stanford University, Stanford, California, USA ldowning@stanford.edu.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rolnick', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine and the National Clinician Scholars Program, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sarah F', 'Initials': 'SF', 'LastName': 'Poole', 'Affiliation': 'Biomedical Informatics Training Program, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Medicine, Hematology and Oncology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Wessels', 'Affiliation': 'Medicine, Stanford School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Heidenreich', 'Affiliation': 'Department of Medicine, Cardiovascular Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shieh', 'Affiliation': 'Medicine, Stanford School of Medicine, Stanford, California, USA.'}]",BMJ quality & safety,['10.1136/bmjqs-2018-008765']
1677,30808567,Immunogenicity of pentavalent rotavirus vaccine in Chinese infants.,"BACKGROUND


A phase III, randomized, double-blind, placebo-controlled clinical study was conducted in China to assess the efficacy, safety, and immunogenicity of the pentavalent rotavirus vaccine (RotaTeq TM , RV5) among Chinese infants. The efficacy and safety data have been previously reported. This report presents the immunogenicity data of the study.
METHODS


4,040 infants aged 6-12 weeks were randomly assigned in a 1:1 ratio to receive 3 oral doses of RV5 or placebo. Trivalent oral poliovirus vaccine (tOPV) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP) were administered in a staggered-use (N = 3,240) or concomitant-use (N = 800) schedule. Immunogenicity of RV5 was evaluated in 800 participants (400 participants from each staggered- and concomitant-use immunogenicity subgroup). Geometric mean titers (GMTs) and seroresponse rates (≥3-fold rise from baseline to PD3) were measured for anti-rotavirus IgA in the staggered- and concomitant-use subgroups and measured for serum neutralizing antibodies (SNAs) to human rotavirus serotypes G1, G2, G3, G4, P1A[8] in the staggered-use subgroup. Immune responses to tOPV and DTaP co-administered with RV5 were also evaluated in the concomitant-use immunogenicity subgroup. (ClinicalTrials.gov registry: NCT02062385) RESULTS: The PD3 GMT and seroresponse rate of anti-rotavirus IgA were higher in the RV5 group (82.42 units/mL, 89.4%) compared to the placebo group (0.33 units/mL, 10.1%). Rotavirus type-specific SNA responses were also higher in the RV5 group compared to the placebo group. In the concomitant-use subgroup, the seroprotection rates of anti-poliovirus type 1, 2, 3 in the participants who received RV5 were non-inferior to those who received placebo, and the antibody responses to DTaP antigens were comparable between the two vaccination groups.
CONCLUSIONS


RV5 was immunogenic in Chinese infants. Immune responses induced by tOPV and DTaP were not affected by the concomitant use of RV5.",2019,"The PD3 GMT and seroresponse rate of anti-rotavirus IgA were higher in the RV5 group (82.42 units/mL, 89.4%) compared to the placebo group (0.33 units/mL, 10.1%).","['800 participants (400 participants from each staggered- and concomitant-use immunogenicity subgroup', '4,040 infants aged 6-12\u202fweeks', 'Chinese infants']","['tOPV and DTaP co-administered with RV5', 'Trivalent oral poliovirus vaccine (tOPV) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP', 'placebo', 'pentavalent rotavirus vaccine (RotaTeq TM , RV5', 'pentavalent rotavirus vaccine', 'RV5 or placebo']","['Geometric mean titers (GMTs) and seroresponse rates (≥3-fold rise from baseline to PD3', 'PD3 GMT and seroresponse rate of anti-rotavirus IgA', 'Immunogenicity of RV5', 'Rotavirus type-specific SNA responses', 'seroprotection rates', 'Immunogenicity', 'efficacy, safety, and immunogenicity']","[{'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2713569', 'cui_str': 'pentavalent rotavirus vaccine (RV5)'}, {'cui': 'C1528013', 'cui_str': 'RotaTeq'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C3476459', 'cui_str': 'Rotavirus IgA'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",4040.0,0.425701,"The PD3 GMT and seroresponse rate of anti-rotavirus IgA were higher in the RV5 group (82.42 units/mL, 89.4%) compared to the placebo group (0.33 units/mL, 10.1%).","[{'ForeName': 'Zhaojun', 'Initials': 'Z', 'LastName': 'Mo', 'Affiliation': 'Guangxi Center for Disease Control and Prevention, Guangxi, PR China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, PR China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Luo', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, PR China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Mo', 'Affiliation': 'Guangxi Center for Disease Control and Prevention, Guangxi, PR China.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Kaplan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Shou', 'Affiliation': 'MSD R&D (China) Co., Ltd., Beijing, PR China.'}, {'ForeName': 'Minghuan', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'MSD R&D (China) Co., Ltd., Beijing, PR China.'}, {'ForeName': 'Darcy A', 'Initials': 'DA', 'LastName': 'Hille', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Arnold', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Xueyan', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': 'MSD R&D (China) Co., Ltd., Beijing, PR China. Electronic address: xue.yan.liao@merck.com.'}]",Vaccine,['10.1016/j.vaccine.2019.02.018']
1678,30770334,Effect of different surface treatment on the shear bond strength of metal brackets to bleached and desensitized enamel.,"INTRODUCTION


The aim of this study was to determine the effect of bleaching and desensitizing on shear bond strength (SBS) of metal brackets to enamel.
METHODS


One hundred extracted human premolar were randomly assigned to 5 groups of 20. In the first group (control), no bleaching or desensitizing agent was used. Groups 2 to 5 were bleached with 37.5% hydrogen peroxide and desensitized with 6.0% potassium nitrate. Surface treatment comprised of etching for 15seconds in groups 1, 2 and 3, Er:yag laser irradiation and etching in group 4 and sandblasting and etching in group 5. Premolar brackets were bonded with Transbond XT and cured for 20seconds and the SBS was tested using a universal testing machine. Adhesive remnant index (ARI) score was used to record the mode of bond failure.
RESULTS


No significant difference was found between the mean SBS (MPa) in groups 1(15.22), 4(14.02), and 5(12.62). SBS in group 4 was significantly higher than group 2 (8.15) (P<0.001). Also, SBS in groups 2 (P<0.001) and 3(11.74) (P=0.012) were significantly lower than group 1. An increased frequency of ARI score of 2 and 3 was observed in groups 1, 4 and 5.
CONCLUSIONS


Bleaching plus desensitizing significantly decreased the SBS of orthodontic brackets. Delaying the bonding procedure for at least 2 weeks or alternative surface treatment methods such as combined laser and acid etching or combined sand blasting and acid etching can improve the SBS.",2019,SBS in group 4 was significantly higher than group 2 (8.15) (P<0.001).,"['One hundred', 'extracted human premolar', 'metal brackets to bleached and desensitized enamel']","['laser irradiation and etching', 'bleaching and desensitizing', 'Transbond XT', 'hydrogen peroxide and desensitized with 6.0% potassium nitrate']","['frequency of ARI score', 'mean SBS (MPa', 'SBS of orthodontic brackets', 'Adhesive remnant index (ARI) score', 'SBS', 'shear bond strength (SBS']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0303749', 'cui_str': 'Bleach (substance)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0303749', 'cui_str': 'Bleach (substance)'}, {'cui': 'C1312066', 'cui_str': 'Transbond XT'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0085428', 'cui_str': 'Dental Braces'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}]",100.0,0.0222809,SBS in group 4 was significantly higher than group 2 (8.15) (P<0.001).,"[{'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Zarif Najafi', 'Affiliation': 'Orthodontic Research Center, Department of Orthodontics, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Rafaat', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Dental Material Department and Biomaterials Research Center, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Pakshir', 'Affiliation': 'Orthodontic Research Center, Department of Orthodontics, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Amin', 'Initials': 'MA', 'LastName': 'Tavakkoli', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: tavakkolident@gmail.com.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Torkan', 'Affiliation': 'Department of orthodontics, University of Washington, Seattle, WA, USA.'}]",International orthodontics,['10.1016/j.ortho.2019.01.008']
1679,30858014,"An environmental cleaning bundle and health-care-associated infections in hospitals (REACH): a multicentre, randomised trial.","BACKGROUND


The hospital environment is a reservoir for the transmission of microorganisms. The effect of improved cleaning on patient-centred outcomes remains unclear. We aimed to evaluate the effectiveness of an environmental cleaning bundle to reduce health care-associated infections in hospitals.
METHODS


The REACH study was a pragmatic, multicentre, randomised trial done in 11 acute care hospitals in Australia. Eligible hospitals had an intensive care unit, were classified by the National Health Performance Authority as a major hospital (public hospitals) or having more than 200 inpatient beds (private hospitals), and had a health-care-associated infection surveillance programme. The stepped-wedge design meant intervention periods varied from 20 weeks to 50 weeks. We introduced the REACH cleaning bundle, a multimodal intervention, focusing on optimising product use, technique, staff training, auditing with feedback, and communication, for routine cleaning. The primary outcomes were incidences of health-care-associated Staphylococcus aureus bacteraemia, Clostridium difficile infection, and vancomycin-resistant enterococci infection. The secondary outcome was the thoroughness of cleaning of frequent touch points, assessed by a fluorescent marking gel. This study is registered with the Australian and New Zealand Clinical Trial Registry, number ACTRN12615000325505.
FINDINGS


Between May 9, 2016, and July 30, 2017, we implemented the cleaning bundle in 11 hospitals. In the pre-intervention phase, there were 230 cases of vancomycin-resistant enterococci infection, 362 of S aureus bacteraemia, and 968 C difficile infections, for 3 534 439 occupied bed-days. During intervention, there were 50 cases of vancomycin-resistant enterococci infection, 109 of S aureus bacteraemia, and 278 C difficile infections, for 1 267 134 occupied bed-days. After the intervention, vancomycin-resistant enterococci infections reduced from 0·35 to 0·22 per 10 000 occupied bed-days (relative risk 0·63, 95% CI 0·41-0·97, p=0·0340). The incidences of S aureus bacteraemia (0·97 to 0·80 per 10 000 occupied bed-days; 0·82, 0·60-1·12, p=0·2180) and C difficile infections (2·34 to 2·52 per 10 000 occupied bed-days; 1·07, 0·88-1·30, p=0·4655) did not change significantly. The intervention increased the percentage of frequent touch points cleaned in bathrooms from 55% to 76% (odds ratio 2·07, 1·83-2·34, p<0·0001) and bedrooms from 64% to 86% (1·87, 1·68-2·09, p<0·0001).
INTERPRETATION


The REACH cleaning bundle was successful at improving cleaning thoroughness and showed great promise in reducing vancomycin-resistant enterococci infections. Our work will inform hospital cleaning policy and practice, highlighting the value of investment in both routine and discharge cleaning practice.
FUNDING


National Health and Medical Research Council (Australia).",2019,"occupied bed-days; 1·07, 0·88-1·30, p=0·4655) did not change significantly.","['hospitals (REACH', '11 acute care hospitals in Australia', 'hospitals', 'Eligible hospitals had an intensive care unit, were classified by the National Health Performance Authority as a major hospital (public hospitals) or having more than 200 inpatient beds (private hospitals), and had a health-care-associated infection surveillance programme', 'Between May 9, 2016, and July 30, 2017']",['environmental cleaning bundle'],"['incidences of S aureus bacteraemia', 'incidences of health-care-associated Staphylococcus aureus bacteraemia, Clostridium difficile infection, and vancomycin-resistant enterococci infection', 'percentage of frequent touch points cleaned', 'C difficile infections', 'vancomycin-resistant enterococci infections', 'thoroughness of cleaning of frequent touch points, assessed by a fluorescent marking gel']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0419786', 'cui_str': 'Infection surveillance (regime/therapy)'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1142423', 'cui_str': 'Bacteremia caused by Staphylococcus aureus'}, {'cui': 'C0343386', 'cui_str': 'Clostridium difficile infection (disorder)'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]",,0.165914,"occupied bed-days; 1·07, 0·88-1·30, p=0·4655) did not change significantly.","[{'ForeName': 'Brett G', 'Initials': 'BG', 'LastName': 'Mitchell', 'Affiliation': 'Faculty of Nursing and Health, Avondale College, Wahroonga, NSW, Australia; School of Nursing and Midwifery, University of Newcastle, Newcastle, NSW, Australia. Electronic address: brett.mitchell@avondale.edu.au.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hall', 'Affiliation': 'School of Public Health, University of Queensland, Herston, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'White', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Barnett', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Halton', 'Affiliation': 'School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Paterson', 'Affiliation': ""University of Queensland Centre for Clinical Research, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.""}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Riley', 'Affiliation': 'School of Biomedical Sciences, The University of Western Australia, Crawley, WA, Australia; School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia; School of Veterinary and Life Sciences, Murdoch University, Murdoch, WA, Australia; PathWest Laboratory Medicine, QEII Medical Centre, Nedlands, WA, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gardner', 'Affiliation': 'School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Farrington', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Gericke', 'Affiliation': 'School of Clinical Medicine, University of Queensland, Herston, QLD, Australia; College of Public Health, Medical and Veterinary Sciences and College of Medicine and Dentistry, James Cook University, Cairns, QLD, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Graves', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30714-X']
1680,30857952,"To Cement or Not? Five-Year Results of a Prospective, Randomized Study Comparing Cemented vs Cementless Total Knee Arthroplasty.","BACKGROUND


The optimal mode of fixation in total knee arthroplasty is a continuing subject of debate.
METHODS


Previously, we reported 2-year results for this prospective, randomized trial. Knee Society Scores, Oxford scores, and pain visual analog scales were collected pre-operatively and post-operatively. Minimum 5-year follow-up has been obtained with radiographic analysis for 85 patients.
RESULTS


Mean Knee Society Scores and Oxford scores and patient-reported outcomes were similar in both groups. Each group had 1 additional revision, but neither was related to implant fixation. Survivorship with revision as an endpoint was equivalent (95.9% and 95.3%, P = .98). There was no significant difference in radiolucencies observed between groups (P = .10), all were non-progressive.
CONCLUSION


Cementless and cemented total knee arthroplasty had equivalent patient-reported outcomes and survivorship at midterm follow-up. Updates are planned at 10 and 15-year intervals to observe long-term modes of failure between these 2 methods of fixation.",2019,"There was no significant difference in radiolucencies observed between groups (P = .10), all were non-progressive.
CONCLUSION


Cementless and cemented total knee arthroplasty had equivalent patient-reported outcomes and survivorship at midterm follow-up.",['85 patients'],[],"['radiolucencies', 'Knee Society Scores, Oxford scores, and pain visual analog scales', 'Mean Knee Society Scores and Oxford scores and patient-reported outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",85.0,0.0868731,"There was no significant difference in radiolucencies observed between groups (P = .10), all were non-progressive.
CONCLUSION


Cementless and cemented total knee arthroplasty had equivalent patient-reported outcomes and survivorship at midterm follow-up.","[{'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Fricka', 'Affiliation': 'Anderson Orthopaedic Research Institute, Inova Center for Joint Replacement at Inova Mount Vernon Hospital, Alexandria, VA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'McAsey', 'Affiliation': 'Anderson Orthopaedic Research Institute, Inova Center for Joint Replacement at Inova Mount Vernon Hospital, Alexandria, VA.'}, {'ForeName': 'Supatra', 'Initials': 'S', 'LastName': 'Sritulanondha', 'Affiliation': 'Anderson Orthopaedic Research Institute, Inova Center for Joint Replacement at Inova Mount Vernon Hospital, Alexandria, VA.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.02.024']
1681,30860059,TAVR in Low-Risk Patients: 1-Year Results From the LRT Trial.,"OBJECTIVES


This study sought to evaluate clinical outcomes and transcatheter heart valve hemodynamics at 1 year after transcatheter aortic valve replacement (TAVR) in low-risk patients.
BACKGROUND


Early results from the LRT (Low Risk TAVR) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis who are at low risk for surgical valve replacement.
METHODS


The LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration-approved Investigational Device Exemption trial to evaluate feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 1 year.
RESULTS


The LRT trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were men. At 30 days, there was zero mortality, zero disabling stroke, and low permanent pacemaker implantation rate (5.0%). At 1-year follow-up, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%. Two (1.0%) subjects underwent surgical reintervention for endocarditis. Of the 14% of TAVR subjects who had evidence of hypoattenuated leaflet thickening at 30 days, there was no impact on valve hemodynamics at 1 year, but the stroke rate was numerically higher (3.8% vs. 1.9%; p = 0.53).
CONCLUSIONS


TAVR in low-risk patients with symptomatic severe aortic stenosis appears to be safe at 1 year. Hypoattenuated leaflet thickening, observed in a minority of TAVR patients at 30 days, did not have an impact on valve hemodynamics in the longer term.",2019,"At 1-year follow-up, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%.","['200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers', 'patients with symptomatic severe aortic stenosis who are at low risk for surgical valve replacement', 'low-risk patients with symptomatic severe aortic stenosis', 'low-risk patients', 'Low-Risk Patients', 'Mean age was 73.6 years and 61.5% were men']","['transcatheter aortic valve replacement (TAVR', 'TAVR']","['permanent pacemaker implantation rate', 'stroke rate', 'valve hemodynamics', 'cause mortality', 'clinical outcomes and valve hemodynamics at 1 year', 'mortality', 'zero mortality, zero disabling stroke, and low permanent pacemaker implantation rate']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0042296', 'cui_str': 'Valves, Surgical'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",200.0,0.193613,"At 1-year follow-up, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%.","[{'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Electronic address: ron.waksman@medstar.net.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Corso', 'Affiliation': 'Department of Cardiac Surgery, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Torguson', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gordon', 'Affiliation': 'Division of Cardiology, Miriam Hospital, Providence, Rhode Island.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Ehsan', 'Affiliation': 'Division of Cardiothoracic Surgery, Lifespan Cardiovascular Institute, Providence, Rhode Island.'}, {'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, Valley Hospital, Ridgewood, New Jersey.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goncalves', 'Affiliation': 'Cardiac Surgery Program, Valley Hospital, Ridgewood, New Jersey.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Levitt', 'Affiliation': ""Department of Cardiology, Henrico Doctors' Hospital, Richmond, Virginia.""}, {'ForeName': 'Chiwon', 'Initials': 'C', 'LastName': 'Hahn', 'Affiliation': ""Department of Cardiothoracic Surgery, Henrico Doctors' Hospital, Richmond, Virginia.""}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Parikh', 'Affiliation': 'Department of Medicine, Stony Brook Hospital, Stony Brook, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bilfinger', 'Affiliation': 'Department of Surgery, Stony Brook Hospital, Stony Brook, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Butzel', 'Affiliation': 'Cardiovascular Service Line, Maine Medical Center, Portland, Maine.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Buchanan', 'Affiliation': 'Cardiovascular Service Line, Maine Medical Center, Portland, Maine.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hanna', 'Affiliation': 'St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, Oklahoma.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garrett', 'Affiliation': 'St. John Cardiovascular Surgery, St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, Oklahoma.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Buchbinder', 'Affiliation': 'Foundation for Cardiovascular Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Asch', 'Affiliation': 'MedStar Health Research Institute, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Weissman', 'Affiliation': 'Department of Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Itsik', 'Initials': 'I', 'LastName': 'Ben-Dor', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Shults', 'Affiliation': 'Department of Cardiac Surgery, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Bastian', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Paige E', 'Initials': 'PE', 'LastName': 'Craig', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Hector M', 'Initials': 'HM', 'LastName': 'Garcia-Garcia', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kolm', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Zou', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Lowell F', 'Initials': 'LF', 'LastName': 'Satler', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Rogers', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.03.002']
1682,30500903,Effect of lifestyle counselling on health-related quality of life in women at high risk for gestational diabetes.,"BACKGROUND


The incidence of gestational diabetes (GDM) is increasing and interventions to curb the detrimental effects of GDM are needed. We have previously reported that a combined diet and physical activity intervention has the potential to reduce GDM among high-risk women. It is also important to know whether the intervention affects health-related quality of life (HRQoL).
METHODS


A total of 378 women at high risk for GDM were randomized into an intervention (lifestyle counselling four times during pregnancy, n=192), or a control group (n=186) before 20 gestational weeks. HRQoL was assessed with the 15D-instrument six times: once during each trimester and at six weeks, six months and 12 months postpartum.
RESULTS


In this study population, the cumulative incidence of GDM was similar in the intervention and the control group (45.7 vs. 44.5%). There was no difference between the 15D scores of the control and intervention groups at any of the time points.
CONCLUSIONS


Combined diet and physical activity intervention did not provide HRQoL benefits in the study. A high prevalence of GDM in both study groups may have confounded the effect of the intervention.",2019,"There was no difference between the 15D scores of the control and intervention groups at any of the time points.
","['women at high risk for gestational diabetes', '378 women at high risk for GDM']","['Combined diet and physical activity intervention', 'combined diet and physical activity intervention', 'intervention (lifestyle counselling', 'lifestyle counselling']","['15D scores', 'health-related quality of life', 'cumulative incidence of GDM', 'HRQoL']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",378.0,0.0434251,"There was no difference between the 15D scores of the control and intervention groups at any of the time points.
","[{'ForeName': 'Niina', 'Initials': 'N', 'LastName': 'Sahrakorpi', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Women's Hospital, Helsinki, Finland.""}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Rönö', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Women's Hospital, Helsinki, Finland.""}, {'ForeName': 'Saila B', 'Initials': 'SB', 'LastName': 'Koivusalo', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Women's Hospital, Helsinki, Finland.""}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Stach-Lempinen', 'Affiliation': 'Department of Obstetrics and Gynecology, South Karelia Central Hospital, Lappeenranta, Finland.'}, {'ForeName': 'Johan G', 'Initials': 'JG', 'LastName': 'Eriksson', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Risto P', 'Initials': 'RP', 'LastName': 'Roine', 'Affiliation': 'Department of Health and Social Management, Research Centre for Comparative Effectiveness and Patient Safety, University of Eastern Finland and Kuopio University Hospital, Kuopio, Finland.'}]",European journal of public health,['10.1093/eurpub/cky248']
1683,30835880,"Effects of blood storage age on immune, coagulation, and nitric oxide parameters in transfused patients undergoing cardiac surgery.","BACKGROUND


Retrospective studies suggested that storage age of RBCs is associated with inflammation and thromboembolism. The Red Cell Storage Duration Study (RECESS) trial randomized subjects undergoing complex cardiac surgery to receive RBCs stored for shorter versus longer periods, and no difference was seen in the primary outcome of change in multiple organ dysfunction score.
STUDY DESIGN AND METHODS


In the current study, 90 subjects from the RECESS trial were studied intensively using a range of hemostasis, immunologic, and nitric oxide parameters. Samples were collected before transfusion and on Days 2, 6, 28, and 180 after transfusion.
RESULTS


Of 71 parameters tested, only 4 showed a significant difference after transfusion between study arms: CD8+ T-cell interferon-γ secretion and the concentration of extracellular vesicles bearing the B-cell marker CD19 were higher, and plasma endothelial growth factor levels were lower in recipients of fresh versus aged RBCs. Plasma interleukin-6 was higher at Day 2 and lower at Days 6 and 28 in recipients of fresh versus aged RBCs. Multiple parameters showed significant modulation after surgery and transfusion. Most analytes that changed after surgery did not differ based on transfusion status. Several extracellular vesicle markers, including two associated with platelets (CD41a and CD62P), decreased in transfused patients more than in those who underwent surgery without transfusion.
CONCLUSIONS


Transfusion of fresh versus aged RBCs does not result in substantial changes in hemostasis, immune, or nitric oxide parameters. It is possible that transfusion modulates the level of platelet-derived extracellular vesicles, which will require study of patients randomly assigned to receipt of transfusion to define.",2019,Plasma interleukin-6 was higher at Day 2 and lower at Days 6 and 28 in recipients of fresh versus aged RBCs.,"['90 subjects from the RECESS trial', 'transfused patients undergoing cardiac surgery']",[],"['immune, coagulation, and nitric oxide parameters', 'CD8+ T-cell interferon-γ secretion and the concentration of extracellular vesicles bearing the B-cell marker CD19', 'plasma endothelial growth factor levels', 'multiple organ dysfunction score', 'Plasma interleukin-6', 'hemostasis, immune, or nitric oxide parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]",[],"[{'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0443980', 'cui_str': 'B-cell marker (substance)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0079280', 'cui_str': 'ECDGF'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1960439', 'cui_str': 'MODS Scores'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",90.0,0.19215,Plasma interleukin-6 was higher at Day 2 and lower at Days 6 and 28 in recipients of fresh versus aged RBCs.,"[{'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Spinella', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine in St. Louis, Saint Louis, Missouri.'}, {'ForeName': 'Roman M', 'Initials': 'RM', 'LastName': 'Sniecinski', 'Affiliation': 'Department of Anesthesiology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Watertown, Massachusetts.'}, {'ForeName': 'Heather C', 'Initials': 'HC', 'LastName': 'Inglis', 'Affiliation': 'Vitalant Research Institute, San Francisco, California.'}, {'ForeName': 'Gayatri', 'Initials': 'G', 'LastName': 'Ranganathan', 'Affiliation': 'New England Research Institutes, Watertown, Massachusetts.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Heitman', 'Affiliation': 'Vitalant Research Institute, San Francisco, California.'}, {'ForeName': 'Fania', 'Initials': 'F', 'LastName': 'Szlam', 'Affiliation': 'Department of Anesthesiology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Danesh', 'Affiliation': 'Vitalant Research Institute, San Francisco, California.'}, {'ForeName': 'Mars', 'Initials': 'M', 'LastName': 'Stone', 'Affiliation': 'Vitalant Research Institute, San Francisco, California.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Keating', 'Affiliation': 'Vitalant Research Institute, San Francisco, California.'}, {'ForeName': 'Jerrold H', 'Initials': 'JH', 'LastName': 'Levy', 'Affiliation': 'Department of Anesthesiology and Critical Care, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Susan F', 'Initials': 'SF', 'LastName': 'Assmann', 'Affiliation': 'New England Research Institutes, Watertown, Massachusetts.'}, {'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'Steiner', 'Affiliation': 'Department of Hematology and Pediatrics, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Doctor', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine in St. Louis, Saint Louis, Missouri.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Norris', 'Affiliation': 'Vitalant Research Institute, San Francisco, California.'}]",Transfusion,['10.1111/trf.15228']
1684,30745147,Impact of a quadrivalent inactivated influenza vaccine on influenza-associated complications and health care use in children aged 6 to 35 months: Analysis of data from a phase III trial in the Northern and Southern Hemispheres.,"BACKGROUND


A multi-season phase III trial conducted in the Northern and Southern Hemispheres demonstrated the efficacy of a quadrivalent split-virion inactivated influenza vaccine (IIV4) in children 6-35 months of age.
METHODS


Data collected during the phase III trial were analysed to examine the vaccine efficacy (VE) of IIV4 in preventing laboratory-confirmed influenza in age subgroups and to determine the relative risk for IIV4 vs. placebo for severe outcomes, healthcare use, and parental absenteeism from work associated with laboratory-confirmed influenza.
RESULTS


VE (95% confidence interval [CI]) to prevent laboratory-confirmed influenza due to any A or B strain was 54.76% (40.24-66.03%) for participants aged 6-23 months and 46.91% (23.57-63.53%) for participants aged 24-35 months. VE (95% CI) to prevent laboratory-confirmed influenza due to vaccine-similar strains was 74.51% (53.55-86.91%) for participants aged 6-23 months and 59.78% (19.11-81.25%) for participants aged 24-35 months. Compared to placebo, IIV4 reduced the risk (95% CI) by 31.28% (8.96-89.34%) for acute otitis media, 21.76% (6.46-58.51%) for acute lower respiratory infection, 40.80% (29.62-55.59%) for healthcare medical visits, 29.71% (11.66-67.23%) for parent absenteeism from work, and 39.20% (26.89-56.24%) for antibiotic use.
CONCLUSION


In children aged 6-35 months, vaccination with IIV4 reduces severe outcomes of influenza as well as the associated burden for their parents and the healthcare system. In addition, vaccination with IIV4 is effective at preventing against influenza in children aged 6-23 and 24-35 months.
TRIAL REGISTRATION


EudraCT no. 2013-001231-51.",2019,"Compared to placebo, IIV4 reduced the risk (95% CI) by 31.28% (8.96-89.34%) for acute otitis media, 21.76% (6.46-58.51%) for acute lower respiratory infection, 40.80% (29.62-55.59%) for healthcare medical visits, 29.71% (11.66-67.23%) for parent absenteeism from work, and 39.20% (26.89-56.24%) for antibiotic use.
CONCLUSION


","['children aged 6 to 35\u202fmonths: Analysis of data from a phase III trial in the Northern and Southern Hemispheres', 'Northern and Southern Hemispheres', 'children aged 6-23 and 24-35\u202fmonths', 'children 6-35\u202fmonths of age']","['EudraCT', 'quadrivalent split-virion inactivated influenza vaccine (IIV4', 'placebo', 'quadrivalent inactivated influenza vaccine']","['healthcare medical visits', 'acute otitis media']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0271429', 'cui_str': 'Acute otitis media (disorder)'}]",,0.181071,"Compared to placebo, IIV4 reduced the risk (95% CI) by 31.28% (8.96-89.34%) for acute otitis media, 21.76% (6.46-58.51%) for acute lower respiratory infection, 40.80% (29.62-55.59%) for healthcare medical visits, 29.71% (11.66-67.23%) for parent absenteeism from work, and 39.20% (26.89-56.24%) for antibiotic use.
CONCLUSION


","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pepin', 'Affiliation': ""Sanofi Pasteur, 1541 Avenue Marcel Merieux, 69820 Marcy-l'Étoile, France. Electronic address: stephanie.pepin@sanofi.com.""}, {'ForeName': 'Sandrine I', 'Initials': 'SI', 'LastName': 'Samson', 'Affiliation': 'Sanofi Pasteur, 1 Discovery Dr, Swiftwater, PA 18370, USA. Electronic address: Sandrine.Samson@sanofi.com.'}, {'ForeName': 'Fabian P', 'Initials': 'FP', 'LastName': 'Alvarez', 'Affiliation': 'Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France. Electronic address: Fabian.Alvarez@sanofi.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dupuy', 'Affiliation': ""Sanofi Pasteur, 1541 Avenue Marcel Merieux, 69820 Marcy-l'Étoile, France. Electronic address: Martin.Dupuy@sanofi.com.""}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Gresset-Bourgeois', 'Affiliation': 'Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France. Electronic address: Viviane.Gresset-Bourgeois@sanofi.com.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Bruijn', 'Affiliation': ""Sanofi Pasteur, 1541 Avenue Marcel Merieux, 69820 Marcy-l'Étoile, France. Electronic address: Iris.DeBruijn@sanofi.com.""}]",Vaccine,['10.1016/j.vaccine.2019.01.059']
1685,30803843,"Immunogenicity, safety, cross-reaction, and immune persistence of an inactivated enterovirus A71 vaccine in children aged from two months to 11 years in Taiwan.","BACKGROUND


To fight against enterovirus A71 (EV-A71)-associated diseases, vaccine development was initiated in Taiwan focusing on two-month-old infants.
METHODS


We conducted a phase II, double-blind, randomised, placebo-controlled study on infants and children aged two months to 11 years. This study was conducted in 4 parts (2a, 2b, 2c, and 2d) with age de-escalation sequentially. Two doses were administered with a 28-day or 56-day interval. Participants aged two months to <two years received a booster dose at one year after the first dose. During the surveillance period, solicited adverse events (AEs) and unsolicited AEs were recorded for safety evaluation. Blood samples were collected for neutralising antibody assay at various times. Immune persistence and booster effects were also assessed.
RESULTS


A total of 363 children completed the study. Most AEs were mild and unrelated to treatment. No vaccine-related serious adverse events (SAEs) were reported. Geometric mean titres (GMTs) of serum neutralising antibody titres increased profoundly. Most participants in the vaccine groups achieved defined seroprotection (neutralization titre ≥ 1:32) after the second vaccination and persisted for two years. Furthermore, the EV-A71 vaccine could provide a cross-reaction against other EV-A71 strain genotypes: B5, C4a, C4b, and C5.
CONCLUSIONS


The mid dose of the EV-A71 vaccine elicited high immune response and were tolerable in participants aged between two months and 11 years in all dosing groups.",2019,Geometric mean titres (GMTs) of serum neutralising antibody titres increased profoundly.,"['infants and children aged two months to 11\u202fyears', 'Taiwan focusing on two-month-old infants', 'Participants aged two months to <two years', 'participants aged between two months and 11\u202fyears in all dosing groups', 'children aged from two months to 11 years in Taiwan', '4 parts (2a, 2b, 2c, and 2d) with age de-escalation sequentially', '363 children completed the study']","['placebo', 'inactivated enterovirus A71 vaccine']","['Geometric mean titres (GMTs) of serum neutralising antibody titres', 'Immunogenicity, safety, cross-reaction, and immune persistence', 'seroprotection (neutralization titre', 'solicited adverse events (AEs) and unsolicited AEs', 'Immune persistence and booster effects']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014383', 'cui_str': 'Enterovirus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010357', 'cui_str': 'Cross Reactions'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",363.0,0.231767,Geometric mean titres (GMTs) of serum neutralising antibody titres increased profoundly.,"[{'ForeName': 'Li-Min', 'Initials': 'LM', 'LastName': 'Huang', 'Affiliation': ""Department of Pediatrics, National Taiwan University Children's Hospital, Taipei, Taiwan.""}, {'ForeName': 'Cheng-Hsun', 'Initials': 'CH', 'LastName': 'Chiu', 'Affiliation': ""Department of Pediatrics, Chang Gung Children's Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan.""}, {'ForeName': 'Nan-Chang', 'Initials': 'NC', 'LastName': 'Chiu', 'Affiliation': ""Department of Pediatrics, MacKay Children's Hospital, Taipei, Taiwan; Department of Medicine, Mackay Medical College, New Taipei City, Taiwan.""}, {'ForeName': 'Chien-Yu', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Pediatrics, Hsinchu MacKay Memorial Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Ming-Ta', 'Initials': 'MT', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Hsinchu MacKay Memorial Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Tsun-Yung', 'Initials': 'TY', 'LastName': 'Kuo', 'Affiliation': 'Department of Biotechnology and Animal Science, National Ilan University, Ilan, Taiwan.'}, {'ForeName': 'Yi-Jen', 'Initials': 'YJ', 'LastName': 'Weng', 'Affiliation': 'Clinical Development Department, Medigen Vaccine Biologics Corp., Taipei, Taiwan.'}, {'ForeName': 'Erh-Fang', 'Initials': 'EF', 'LastName': 'Hsieh', 'Affiliation': 'Clinical Development Department, Medigen Vaccine Biologics Corp., Taipei, Taiwan.'}, {'ForeName': 'I-Chen', 'Initials': 'IC', 'LastName': 'Tai', 'Affiliation': 'Clinical Development Department, Medigen Vaccine Biologics Corp., Taipei, Taiwan. Electronic address: kathytai@medigenvac.com.'}]",Vaccine,['10.1016/j.vaccine.2019.02.023']
1686,30803472,Evaluation of the Ability of Five- to 11-Year-Olds to Brush Their Teeth Effectively with Manual and Electric Toothbrushing.,"Purpose:  This study's purposes were to: (1) correlate toothbrushing effectiveness measured by plaque removal with children's parent- reported ability to perform life tasks and their executive function; and (2) compare plaque removal by children using a manual versus electric toothbrush.  Methods:  A convenience sample of 120 healthy five- to 11-year-olds was randomly and evenly assigned to manual or electric tooth- brush groups. A questionnaire was developed from items selected from previously validated social science instruments and completed by caregivers. Plaque was measured by calibrated scorers using the Oral Hygiene Index-Simplified before and after children brushed with respective toothbrushes. Statistical significance was established at P<0.05.  Results:  The type of toothbrush had no effect on brushing effectiveness. Ability to write a complete address, tie shoes independently, cut meat with a knife, and cut out complex shapes were associated with better toothbrushing effectiveness. Increasing ability to play a musical instrument and wash dishes independently were associated with increased plaque removal. Parents were good predictors of a child's readiness to brush, based on plaque removal scores.  Conclusions:  Certain life skills and quality of performance of tasks were associated with toothbrushing effectiveness in five- to 11-year-olds and may be used to determine a child's readiness to brush independently.",2019,Plaque was measured by calibrated scorers using the Oral Hygiene Index-Simplified before and after children brushed with respective toothbrushes.,['120 healthy five- to 11-year-olds'],"['manual versus electric toothbrush', 'manual or electric tooth- brush groups', 'Manual and Electric Toothbrushing']","['plaque removal', 'brushing effectiveness', 'toothbrushing effectiveness']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0040461', 'cui_str': 'Toothbrushing'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0040461', 'cui_str': 'Toothbrushing'}]",120.0,0.0196058,Plaque was measured by calibrated scorers using the Oral Hygiene Index-Simplified before and after children brushed with respective toothbrushes.,"[{'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Kerr', 'Affiliation': 'Dr. Kher is a dentist in private practice in Goodyear, Ariz., USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Claman', 'Affiliation': 'Dr. Claman is a clinical assistant professor, all at the Division of Pediatric Dentistry at the Ohio State College of Dentistry, The Ohio State University, Columbus, Ohio, USA;, Email: claman.5@osu.edu.'}, {'ForeName': 'Homa', 'Initials': 'H', 'LastName': 'Amini', 'Affiliation': 'Dr. Amini is a clinical professor, all at the Division of Pediatric Dentistry at the Ohio State College of Dentistry, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Alexy', 'Affiliation': ""Ms. Alexy is a biostatistician, Nationwide Children's Hospital, Columbus, Ohio, USA.""}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Dr. Kumar is a clinical professor, all at the Division of Pediatric Dentistry at the Ohio State College of Dentistry, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Casamassimo', 'Affiliation': 'Dr. Casamassimo is Professor Emeritus, all at the Division of Pediatric Dentistry at the Ohio State College of Dentistry, The Ohio State University, Columbus, Ohio, USA.'}]",Pediatric dentistry,[]
1687,30837192,"Effectiveness of balance exercise among older adults in Depok City, Indonesia.","OBJECTIVE


Falls are a serious problem for older adults. Balance impairment is one of the most significant reasons why adults fall from a standing position. This study aims to investigate the effect of an eight-week postural balance exercise intended to reduce the risk of falls among older adults in a community in Depok City, Indonesia.
METHOD


This quasi-experimental study employed a pre- and post-test design using a control group. The study involved an intervention group of 30 respondents and a control group of a further 30 respondents. The sample was selected using multistage random sampling. The data were analyzed using a t-test.
RESULTS


The balance exercise significantly affected the respondents' postural balance and reduced their risk of falling. There were significant differences between the two groups (intervention group and control group) in postural balance (p < 0.001) and the risk of suffering a fall (p = 0.023). CONCLUSIóN: Balance exercises can be utilized as one of the preventive efforts to maintain postural balance and reduce the risk of falls among older adults. Future studies may consider the variation of age to more accurately determine the effectiveness of this balance exercise.",2019,"There were significant differences between the two groups (intervention group and control group) in postural balance (p<.001) and the risk of suffering a fall (p=.023).
","['older adults in a community in Depok City, Indonesia', '30 respondents and a control group of a further 30 respondents', 'older adults in Depok City, Indonesia', 'older adults']","['balance exercise', 'eight-week postural balance exercise', 'Balance exercises']","['risk of falling', 'postural balance (p<.001) and the risk of suffering a fall (p=.023', 'risk of falls']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}]",,0.0211157,"There were significant differences between the two groups (intervention group and control group) in postural balance (p<.001) and the risk of suffering a fall (p=.023).
","[{'ForeName': 'Stefanus Mendes', 'Initials': 'SM', 'LastName': 'Kiik', 'Affiliation': 'Stikes Maranatha Kupang, East Nusa Tenggara, Indonesia; Faculty of Nursing, Universitas Indonesia, West Java, Indonesia. Electronic address: stefanusmendeskiik@ymail.com.'}, {'ForeName': 'Junaiti', 'Initials': 'J', 'LastName': 'Sahar', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, West Java, Indonesia.'}, {'ForeName': 'Henny', 'Initials': 'H', 'LastName': 'Permatasari', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, West Java, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.01.004']
1688,30817246,Effect of Trendelenburg position and lower-body positive pressure on neck fluid distribution.,"Fluid that shifts out of the legs and into the neck when supine can contribute to upper-airway narrowing. The present study investigates the relative contributions of vascular and extravascular fluid to the total accumulation of neck fluid volume (NFV). In 22 healthy awake participants (8 women), aged 42 ± 9 yr, we measured NFV with bioelectrical impedance, internal jugular vein volume (IJVV) with ultrasound, and extravascular NFV (NFV EV ) as the difference between NFV and IJVV. Participants were randomly allocated to control and intervention, both of which were conducted on the same day. Measurements were made at baseline and every 5 min thereafter during control and intervention. During intervention, participants received 40 mmHg lower-body positive pressure (LBPP) when supine, followed by LBPP plus 10° Trendelenburg position, then LBPP when supine again, followed by recovery. During control, participants lay supine for equal time. LBPP and LBPP plus Trendelenburg position both increased NFV from baseline compared with control ( P  < 0.001), with significant contributions from IJVV ( P  < 0.001). Returning to supine with LBPP, IJVV returned to baseline, but NFV remained elevated because of accumulation of NFV EV.  These findings suggest that contributions of IJVV to NFV are immediate but transient, whereas sustained elevation in NFV when supine is likely a result of NFV EV . These findings add new insights into the mechanism by which fluid accumulates in the neck by rostral fluid shift.  NEW & NOTEWORTHY  This study demonstrates that lying supine for 30 min as well as increased fluid shift out of the legs to simulate nocturnal rostral fluid shift causes fluid to accumulate mainly in the extravascular space of the neck rather than in the internal jugular veins. Therefore, in subjects without fluid-retaining states, extravascular neck fluid accumulation overnight might play a more significant role in the pathophysiology of upper-airway narrowing than intravascular fluid accumulation.",2019,"LBPP and LBPP plus Trendelenburg position both increased NFV from baseline compared with control ( P  < 0.001), with significant contributions from IJVV ( P  < 0.001).","['22 healthy awake participants (8 women), aged 42\u2009±\u20099 yr']","['Trendelenburg position and lower-body positive pressure', '40 mmHg lower-body positive pressure (LBPP']","['LBPP and LBPP plus Trendelenburg position both increased NFV', 'NFV with bioelectrical impedance, internal jugular vein volume (IJVV) with ultrasound, and extravascular NFV (NFV EV ']","[{'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0277812', 'cui_str': 'Trendelenburg Position'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0277812', 'cui_str': 'Trendelenburg Position'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]",22.0,0.0416471,"LBPP and LBPP plus Trendelenburg position both increased NFV from baseline compared with control ( P  < 0.001), with significant contributions from IJVV ( P  < 0.001).","[{'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Yadollahi', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network , Toronto, Ontario , Canada.'}, {'ForeName': 'Bhajan', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network , Toronto, Ontario , Canada.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Millar', 'Affiliation': 'Human Health and Nutritional Sciences, University of Guelph , Guelph, Ontario , Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vena', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network , Toronto, Ontario , Canada.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Floras', 'Affiliation': 'Department of Medicine, University of Toronto , Toronto, Ontario , Canada.'}, {'ForeName': 'T Douglas', 'Initials': 'TD', 'LastName': 'Bradley', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network , Toronto, Ontario , Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00926.2018']
1689,30831358,"Influence of finishing/polishing on the fatigue strength, surface topography, and roughness of an yttrium-stabilized tetragonal zirconia polycrystals subjected to grinding.","This study aimed to evaluate the effects of various polishing systems associated or not to finishing with diamond burs of lower-grit size on the topography, roughness, and fatigue behavior of a ground yttrium-stabilized tetragonal polycrystalline zirconia (Y-TZP). Disc specimens of Y-TZP (Zenostar T, Ivoclar-Vivadent) were produced (diameter = 15 mm, thickness = 1.2 ± 0.2 mm; ISO 6872-2015) and randomly allocated into 8 groups: [Ctrl] as-sintered; [Gr] ground with coarse diamond bur; [Gr+Eve] grinding + polishing with EveDiacera (2-step polishing system); [Gr+Fin+Eve] grinding + finishing + polishing with EveDiacera; [Gr+Kg] grinding + polishing with Kg Viking (2-step polishing system); [Gr+Fin+Kg] grinding + finishing + polishing with Kg Viking; [Gr+Op] grinding + polishing with Optrafine (3-step polishing system); and [Gr+Fin+Op] grinding + finishing + polishing with Optrafine. Next, surface topography, roughness, phase transformation, fatigue strength (staircase method), and fractography analyses were performed. Grinding changed the surface topography and generated higher roughness (Ra in μm) (1.214); the subsequent finishing/polishing procedures were able to reduce the roughness (0.326-0.839); however, it remained higher than the control [ctrl] group (0.221). All samples subjected to surface treatment presented an increase in m-phase content (8.04-17.46%). In terms of fatigue strength (in MPa), the grinding group (677.36) and polishing/finishing groups (641.66-707.20) presented higher fatigue strength than the control [ctrl] group (592.48). Finishing before polishing had no effect on fatigue strength (645.37-707.20). Grinding altered the Y-TZP surface features and increased their fatigue strength by phase transformation mechanism, while the finishing/polishing procedures promoted surface smoothening, while maintaining high fatigue strengths. Finishing as an additional step before polishing had no effect on roughness reduction and fatigue strength improvements; thus, the finishing procedure might be unnecessary.",2019,"Grinding changed the surface topography and generated higher roughness (Ra in μm) (1.214); the subsequent finishing/polishing procedures were able to reduce the roughness (0.326-0.839); however, it remained higher than the control [ctrl] group (0.221).",[],"['coarse diamond bur; [Gr+Eve] grinding\u202f+\u202fpolishing with EveDiacera (2-step polishing system); [Gr+Fin+Eve] grinding\u202f+\u202ffinishing\u202f+\u202fpolishing with EveDiacera; [Gr+Kg] grinding +\u202fpolishing with Kg Viking (2-step polishing system); [Gr+Fin+Kg] grinding\u202f+\u202ffinishing\u202f+\u202fpolishing with Kg Viking; [Gr+Op] grinding\u202f+\u202fpolishing with Optrafine (3-step polishing system); and [Gr+Fin+Op] grinding\u202f+\u202ffinishing\u202f+\u202fpolishing with Optrafine', 'ground yttrium-stabilized tetragonal polycrystalline zirconia (Y-TZP', 'TZP', 'finishing/polishing']","['roughness reduction and fatigue strength improvements', 'fatigue strength, surface topography, and roughness', 'fatigue strength', 'm-phase content', 'Next, surface topography, roughness, phase transformation, fatigue strength (staircase method), and fractography analyses']",[],"[{'cui': 'C0205194', 'cui_str': 'Coarse (qualifier value)'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur (physical object)'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding (procedure)'}, {'cui': 'C0032377', 'cui_str': 'Polishes'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0007591', 'cui_str': 'M Phase'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",,0.020953,"Grinding changed the surface topography and generated higher roughness (Ra in μm) (1.214); the subsequent finishing/polishing procedures were able to reduce the roughness (0.326-0.839); however, it remained higher than the control [ctrl] group (0.221).","[{'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: camila-svs@hotmail.com.'}, {'ForeName': 'Kiara Serafini', 'Initials': 'KS', 'LastName': 'Dapieve', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: kiara_s_d@hotmail.com.'}, {'ForeName': 'Marília Pivetta', 'Initials': 'MP', 'LastName': 'Rippe', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: mariliarippe@mail.ufsm.br.'}, {'ForeName': 'Gabriel Kalil Rocha', 'Initials': 'GKR', 'LastName': 'Pereira', 'Affiliation': 'School of Dentistry, Meridional Faculty - IMED, Passo Fundo, Rio Grande do Sul State, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Marco Cícero', 'Initials': 'MC', 'LastName': 'Bottino', 'Affiliation': 'School of Dentistry, Dept. of Cariology, Restorative Sciences, Endodontics, University of Michigan, Ann Arbor, MI, USA. Electronic address: mbottino@umich.edu.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: lfvalandro@hotmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.02.013']
1690,30839426,"Can a brief psychological expectancy intervention improve postoperative pain? A randomized, controlled trial in patients with breast cancer.","Pain after surgery remains a major health problem, calling for optimized treatment regimens to maximize the efficacy of pharmacological interventions. In this randomized controlled trial, we tested in a routine surgical treatment setting whether postoperative pain can be reduced by a brief preoperative intervention, ie, positive verbal suggestions in combination with sham acupuncture, designed to optimize treatment expectations. We hypothesized that the expectancy intervention as add-on to patient-controlled intravenous analgesia with morphine reduces patient-reported postoperative pain and improves satisfaction with analgesia. Ninety-six women undergoing breast cancer surgery were randomized at 2 stages: Before surgery, anesthesiologists delivered either positive or neutral verbal suggestions regarding the benefits of acupuncture needling on postoperative pain (""information condition""). Patients were then randomized to receive sham acupuncture or no sham acupuncture during postoperative care (""sham acupuncture condition""). Average pain during the 24-hour observation period after surgery as primary and satisfaction with analgesia as secondary outcome was assessed with standardized measures and analyzed with analysis of covariance accounting for morphine dose, surgery-related, and psychological parameters. Postoperative pain ratings were significantly reduced in patients who received positive treatment-related suggestions (F = 4.45, P = 0.038, main effect of information). Moreover, patients who received an intervention aimed at optimized treatment expectations reported significantly greater satisfaction with analgesia (F = 4.89, P = 0.030, interaction effect). Together, our proof-of-concept data support that optimizing treatment expectations through verbal suggestions may offer a promising approach to improve patient-reported outcomes. Future translational and clinical studies are needed to test such psychological strategies in different surgical interventions, patient groups, and pharmacological treatment regimens.",2019,"Postoperative pain ratings were significantly reduced in patients who received positive treatment-related suggestions (F = 4.45, P = 0.038, main effect of information).","['patients with breast cancer', 'Ninety-six women undergoing breast cancer surgery']","['anesthesiologists delivered either positive or neutral verbal suggestions regarding the benefits of acupuncture needling', 'morphine', 'psychological expectancy intervention', 'sham acupuncture or no sham acupuncture during postoperative care (""sham acupuncture condition']","['Pain', 'satisfaction with analgesia', 'Postoperative pain ratings', 'Average pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0181956', 'cui_str': 'Acupuncture needle, device (physical object)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",96.0,0.346748,"Postoperative pain ratings were significantly reduced in patients who received positive treatment-related suggestions (F = 4.45, P = 0.038, main effect of information).","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'Klinik für Anästhesiologie und Intensivmedizin, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Hoffmann', 'Affiliation': 'Clinic for Obstetrics and Gynecology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Pasler', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': 'Clinic for Neurology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Schedlowski', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Peters', 'Affiliation': 'Klinik für Anästhesiologie und Intensivmedizin, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Elsenbruch', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ulrich H', 'Initials': 'UH', 'LastName': 'Frey', 'Affiliation': 'Klinik für Anästhesiologie und Intensivmedizin, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}]",Pain,['10.1097/j.pain.0000000000001546']
1691,30827757,Baseline effective connectivity predicts response to repetitive transcranial magnetic stimulation in patients with treatment-resistant depression.,"Repetitive transcranial magnetic stimulation (rTMS) has become a popular treatment option for treatment-resistant depression (TRD). However, suboptimal response rates highlight the need for improved efficacy through optimisation of treatment protocol and patient selection. We investigate whether the limbic salience network and its connectivity with prefrontal stimulation sites predict immediate and longer-term responsiveness to rTMS. Twenty-seven patients with TRD were randomly allocated to receive 16 sessions of either conventional rTMS or intermittent theta-burst (iTBS) over 4 weeks; delivered using connectivity profiling and neuronavigation to target person-specific dorsolateral prefrontal cortex (DLPFC). At baseline and 3-month follow-up, patients underwent clinical assessment and scanning session, and 1-month clinical follow-up. Resting-state fMRI data were entered into seed-based functional and effective connectivity analyses between right anterior insula (rAI) and DLPFC target, and independent components analysis to extract resting-state networks. Cerebral blood flow (CBF) was also assessed in the rAI. All brain measures were compared between baseline and follow-up, and related to treatment response at 1- and 3-months. Baseline fronto-insular effective connectivity and salience network connectivity were significantly positively correlated, while baseline rAI CBF was negatively correlated, with early (1-month) response to rTMS treatment but not sustained response (3-months), suggesting persistence of therapeutic response is not associated with baseline features. Connectivity or CBF measures did not change between the two time points. We demonstrate that fronto-insular and salience-network interactions can predict early response to rTMS in TRD, suggesting that these network nodes may be key regions toward developing rTMS response biomarkers.",2019,Connectivity or CBF measures did not change between the two time points.,"['Twenty-seven patients with TRD', 'patients with treatment-resistant depression']","['repetitive transcranial magnetic stimulation', 'conventional rTMS or intermittent theta-burst (iTBS) over 4 weeks; delivered using connectivity profiling and neuronavigation to target person-specific dorsolateral prefrontal cortex (DLPFC', 'rTMS', 'Repetitive transcranial magnetic stimulation (rTMS']","['Cerebral blood flow (CBF', 'baseline rAI', 'Connectivity or CBF measures', 'CBF', 'Baseline fronto-insular effective connectivity and salience network connectivity']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1136207', 'cui_str': 'Frameless Stereotaxy'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",27.0,0.0327343,Connectivity or CBF measures did not change between the two time points.,"[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Iwabuchi', 'Affiliation': ""NIHR Nottingham Biomedical Research Centre, Queen's Medical Centre, University of Nottingham, Nottingham NG7 2UH, United Kingdom; Sir Peter Mansfield Imaging Centre, School of Medicine, University of Nottingham, University Park, Nottingham NG7 2RD, United Kingdom.""}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Auer', 'Affiliation': ""NIHR Nottingham Biomedical Research Centre, Queen's Medical Centre, University of Nottingham, Nottingham NG7 2UH, United Kingdom; Sir Peter Mansfield Imaging Centre, School of Medicine, University of Nottingham, University Park, Nottingham NG7 2RD, United Kingdom.""}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Lankappa', 'Affiliation': 'Nottinghamshire Healthcare NHS Foundation Trust, Nottingham NG7 2UH, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Palaniyappan', 'Affiliation': 'Departments of Psychiatry and Medical Biophysics and Robarts Research Institute, Western University, London, ON, Canada; Lawson Health Research Institute, London, ON, Canada. Electronic address: lpalaniy@uwo.ca.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.02.012']
1692,30811354,Tissue Adhesive for Wound Closure Reduces Immediate Postoperative Wound Dressing Changes After Primary TKA: A Randomized Controlled Study in Simultaneous Bilateral TKA.,"BACKGROUND


Prolonged wound drainage after TKA is associated with increased risk of infection. To decrease wound drainage, tissue adhesive has been suggested as an adjunct to wound closure after TKA; however, no studies of which we are aware have investigated the effect of tissue adhesive in a modern fast-track TKA setting.
QUESTIONS/PURPOSES


The purpose of this study was to evaluate the effect of wound closure using a high-viscosity tissue adhesive in simultaneous bilateral TKA with respect to (1) postoperative wound drainage, measured as number of dressing changes in the first 72 hours postoperatively; and (2) wound healing assessed using the ASEPSIS score.
METHODS


Thirty patients undergoing simultaneous bilateral TKA were included in the study. The left knee was randomized to receive either standard three-layer closure with staples or the same closure supplemented with tissue adhesive with the opposite treatment used on the contralateral knee. One patient underwent a constrained TKA and underwent revision 2 days after the index procedure and was therefore excluded leaving 29 patients (58 knees) for analysis. Sixty-two percent (n = 18) were female. Mean age was 64 years (range, 42-78 years). Mean body mass index was 28 kg/m (range, 21-38 kg/m). Postoperative wound drainage was evaluated as drainage resulting in a dressing change. The wound dressing was changed if it was soaked to the borders of the absorbable dressing at any point. The nurses changing the dressing were blinded to treatment allocation up to the first dressing change. The number of dressing changes during the first 72 hours postoperatively was recorded. The secondary study endpoint was the ASEPSIS score, which is a clinical score assessing wound healing. ASEPSIS score, measured by a nurse not involved in the treatment, was compared between the groups at 3 weeks followup.
RESULTS


Knees with tissue adhesive underwent fewer dressing changes (median, 0; interquartile range [IQR], 0-1) compared with the contralateral knee (IQR, 1-2; difference of medians, one dressing change; p = 0.001). A total of 59% of knees in the intervention group did not undergo any dressing changes before discharge, whereas 24% of knees in the control group did not undergo any dressing changes before discharge (p = 0.02). The knees in the intervention group and the control group did not differ with respect to ASEPSIS score at 3 weeks.
CONCLUSIONS


Tissue adhesive as an adjunct to standard wound closure after primary TKA reduced the number of dressing changes after surgery, but did not change the appearance or healing of the wound at 3 weeks based on the ASEPSIS scores. Whether the small differences observed here in terms of the number of dressing changes performed will justify the additional costs associated with using this product or whether there are other differences associated with the use of tissue adhesive that may prove important such as patient preferences or longer term differences in wound healing or infection should be studied in the future.
LEVEL OF EVIDENCE


Level I, therapeutic study.",2019,"The knees in the intervention group and the control group did not differ with respect to ASEPSIS score at 3 weeks.
","['Mean age was 64 years (range, 42-78 years', 'After Primary TKA', 'Thirty patients undergoing simultaneous bilateral TKA were included in the study', 'Sixty-two percent (n = 18) were female']","['constrained TKA', 'standard three-layer closure with staples or the same closure supplemented with tissue adhesive with the opposite treatment used on the contralateral knee']","['Mean body mass index', 'appearance or healing of the wound', 'Postoperative wound drainage', 'ASEPSIS score, which is a clinical score assessing wound healing', 'number of dressing changes']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1293123', 'cui_str': 'Layered closure - action'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0040277', 'cui_str': 'Tissue Adhesives'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0920263', 'cui_str': 'Wound drainage'}, {'cui': 'C0003974', 'cui_str': 'Asepsis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0085671', 'cui_str': 'Dressing change'}]",30.0,0.0535058,"The knees in the intervention group and the control group did not differ with respect to ASEPSIS score at 3 weeks.
","[{'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Gromov', 'Affiliation': 'K. Gromov, A. Troelsen, S. Raaschou, H. Sandhold, C. Skovgaard Nielsen, H. Husted, Department of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark H. Kehlet, Section for Surgical Pathophysiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': ''}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Raaschou', 'Affiliation': ''}, {'ForeName': 'Håkon', 'Initials': 'H', 'LastName': 'Sandhold', 'Affiliation': ''}, {'ForeName': 'Christian Skovgaard', 'Initials': 'CS', 'LastName': 'Nielsen', 'Affiliation': ''}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': ''}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Husted', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000637']
1693,30809646,"Effects of a randomized, culturally adapted, lifestyle intervention on mental health among Middle-Eastern immigrants.","BACKGROUND


Middle-Eastern immigrants in Sweden are at increased risk for type 2 diabetes (T2D) and poor mental health. Physical activity not only prevents/delays onset of T2D but also shows favorable effects on mental health. However, the effects of a culturally adapted lifestyle intervention on mental health among Middle-Eastern immigrants have not been explored before. We aimed to study the effects of a randomized controlled, culturally adapted lifestyle intervention on anxiety and depression levels in diabetes-prone Iraqi immigrants.
METHODS


Participants (n = 96) were randomized to intervention group, IG (n = 50) or control group, CG (n = 46). The IG received seven group sessions addressing lifestyle change and the CG received treatment as usual. Montgomery-Åsberg Depression Rating Scale (MADRS-S) and Hospital Anxiety and Depression Scale (HADS) assessed mental health at start, mid (2 months) and end of the study (4 months). Proportional odds ratio (OR) model was used to study the effect of the intervention.
RESULTS


The odds of scoring lower on MADRS-S and HADS depression scale at visit 3 vs. baseline were higher in the IG compared to the CG (MADRS-S OR 5.9, 95% CI: 1.6-22.5; HADS OR 4.4, 95% CI: 0.9-20.3). The findings persisted after adjustment for age, sex, body mass index, time since migration, sedentary lifestyle and language spoken at home. Group differences were non-significant at visit 2 vs. baseline.
CONCLUSION


A culturally adapted lifestyle intervention addressing T2D prevention in Middle-Eastern immigrants has favorable effects on mental health. The effect was more pronounced at the 4 months than at 2 months follow-up, indicating beneficial effect of longer study duration.
TRIAL REGISTRATION


www.clinicaltrials.gov NCT01420198.",2019,"The odds of scoring lower on MADRS-S and HADS depression scale at visit 3 vs. baseline were higher in the IG compared to the CG (MADRS-S OR 5.9, 95% CI: 1.6-22.5; HADS OR 4.4, 95% CI: 0.9-20.3).","['Participants (n = 96', 'mental health among Middle-Eastern immigrants', 'Middle-Eastern immigrants', 'Middle-Eastern immigrants in Sweden', 'diabetes-prone Iraqi immigrants']","['culturally adapted, lifestyle intervention', 'control group, CG', 'culturally adapted lifestyle intervention']","['Montgomery-Åsberg Depression Rating Scale (MADRS-S) and Hospital Anxiety and Depression Scale (HADS) assessed mental health', 'MADRS-S and HADS depression scale', 'anxiety and depression levels']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1556087', 'cui_str': 'Iraqi (ethnic group)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",96.0,0.0508681,"The odds of scoring lower on MADRS-S and HADS depression scale at visit 3 vs. baseline were higher in the IG compared to the CG (MADRS-S OR 5.9, 95% CI: 1.6-22.5; HADS OR 4.4, 95% CI: 0.9-20.3).","[{'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Clinical Sciences, Lund University, Malmö, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Lindblad', 'Affiliation': 'Department of Community Medicine/Primary Health Care, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical Sciences, Lund University, Malmö, Sweden.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bennet', 'Affiliation': 'Department of Clinical Sciences, Lund University, Malmö, Sweden.'}]",European journal of public health,['10.1093/eurpub/ckz020']
1694,30813779,Change in cardiac troponin T level after intravitreal anti-vascular endothelial growth factor treatment: Prospective pilot study.,"BACKGROUND


Evaluate subclinical myocardial injury associated with intravitreal anti-vascular endothelial growth factor therapy by measuring serum high-sensitivity cardiac troponin T.
METHODS


This is a prospective pilot comparative study conducted at American University of Beirut Medical Center, Beirut, Lebanon. In total, 40 consecutive patients were randomized to receive either intravitreal bevacizumab or ranibizumab. Patients received three consecutive monthly injections of the assigned drug, then continued treatment as needed. Systemic concentrations of high-sensitivity cardiac troponin T and vascular endothelial growth factor were obtained at baseline, week 9, and week 24. Primary endpoint measure was change in high-sensitivity cardiac troponin T levels compared to baseline. Secondary endpoint measure was change in systemic vascular endothelial growth factor levels.
RESULTS


There was no significant difference in high-sensitivity cardiac troponin T levels over time ( p  = 0.227) within each treatment group and no significant difference between treatments at any time point ( p  = 0.276). There was a significant decrease in plasma vascular endothelial growth factor levels at week 9 ( p  = 0.001) and week 24 ( p  < 0.001) compared to baseline. In the ranibizumab group, vascular endothelial growth factor levels were not significantly different at weeks 9 and 24 compared to baseline ( p  = 0.708 and  p  = 0.117, respectively). There was a significant association between the number of bevacizumab injections from weeks 8 to 24 and the decrease in vascular endothelial growth factor levels at week 24 ( R  = -0.67,  p  = 0.032). This correlation was not observed in the ranibizumab group ( R  = -0.341,  p  = 0.141).
CONCLUSION


Repeated intravitreal bevacizumab or ranibizumab did not influence serum high-sensitivity cardiac troponin levels. Intravitreal bevacizumab but not ranibizumab lowered free-systemic vascular endothelial growth factor levels, which was observed in this study to be inversely related to the number of bevacizumab injections.",2020,There was a significant decrease in plasma vascular endothelial growth factor levels at week 9 ( p = 0.001) and week 24 ( p < 0.001) compared to baseline.,"['at American University of Beirut Medical Center, Beirut, Lebanon', '40 consecutive patients']","['intravitreal bevacizumab or ranibizumab', 'intravitreal anti-vascular endothelial growth factor therapy', 'Intravitreal bevacizumab', 'bevacizumab or ranibizumab', 'ranibizumab']","['free-systemic vascular endothelial growth factor levels', 'vascular endothelial growth factor levels', 'systemic vascular endothelial growth factor levels', 'Systemic concentrations of high-sensitivity cardiac troponin T and vascular endothelial growth factor', 'high-sensitivity cardiac troponin T levels', 'cardiac troponin T level', 'plasma vascular endothelial growth factor levels', 'serum high-sensitivity cardiac troponin levels', 'change in high-sensitivity cardiac troponin T levels']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0023190', 'cui_str': 'Lebanese Republic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C3538889', 'cui_str': 'Cardiac troponin T (substance)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",40.0,0.115786,There was a significant decrease in plasma vascular endothelial growth factor levels at week 9 ( p = 0.001) and week 24 ( p < 0.001) compared to baseline.,"[{'ForeName': 'Abdallah G', 'Initials': 'AG', 'LastName': 'Rebeiz', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Ziyad', 'Initials': 'Z', 'LastName': 'Mahfoud', 'Affiliation': 'Department of Global and Public Health, Weill Cornell Medical College, Doha, Qatar.'}, {'ForeName': 'Maamoun', 'Initials': 'M', 'LastName': 'Abdul Fattah', 'Affiliation': 'Department of Ophthalmology, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Saad', 'Affiliation': ""Damien Gatinel's Department of Ophthalmology, Rothschild Foundation, Paris, France.""}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Safar', 'Affiliation': 'Department of Ophthalmology, American Hospital Dubai, Dubai, UAE.'}, {'ForeName': 'Ziad F', 'Initials': 'ZF', 'LastName': 'Bashshur', 'Affiliation': 'Department of Ophthalmology, American University of Beirut, Beirut, Lebanon.'}]",European journal of ophthalmology,['10.1177/1120672119832171']
1695,30854874,Effects of Acceptance and Commitment Therapy on Impulsive Decision-Making.,"This study examined the transdiagnostic effect of acceptance and commitment therapy (ACT) on impulsive decision-making in a community sample. A total of 40 adults were randomized to eight individual sessions of ACT or an inactive control. Participants completed pre-, mid-, and post-assessments for psychological symptoms; overall behavior change; valued living; delay discounting; psychological flexibility; and distress tolerance. Data were analyzed with multilevel modeling of growth curves. Significant interaction effects of time and condition were observed for psychological flexibility, distress tolerance, psychological symptoms, and the obstruction subscale of valued living. No significant interaction effect was found for two delay discounting tasks nor the progress subscale of valued living. The ACT condition had a significantly larger reduction of problem behavior at post-assessment. The results support use of ACT as a transdiagnostic treatment for impulsive behaviors. The lack of change in delay discounting contrasts previous research.",2020,"Significant interaction effects of time and condition were observed for psychological flexibility, distress tolerance, psychological symptoms, and the obstruction subscale of valued living.",['40 adults'],"['Acceptance and Commitment Therapy', 'acceptance and commitment therapy (ACT', 'ACT', 'ACT or an inactive control']","['psychological symptoms; overall behavior change; valued living; delay discounting; psychological flexibility; and distress tolerance', 'psychological flexibility, distress tolerance, psychological symptoms, and the obstruction subscale of valued living', 'progress subscale of valued living', 'problem behavior']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Decision Making'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}]",40.0,0.0463857,"Significant interaction effects of time and condition were observed for psychological flexibility, distress tolerance, psychological symptoms, and the obstruction subscale of valued living.","[{'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Morrison', 'Affiliation': 'Utah Center for Evidence Based Treatment, Salt Lake City, UT, USA.'}, {'ForeName': 'Brooke M', 'Initials': 'BM', 'LastName': 'Smith', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Clarissa W', 'Initials': 'CW', 'LastName': 'Ong', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Lee', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Friedel', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Odum', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Madden', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ledermann', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Rung', 'Affiliation': 'Utah State University, Logan, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Twohig', 'Affiliation': 'Utah State University, Logan, USA.'}]",Behavior modification,['10.1177/0145445519833041']
1696,32022282,"A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics.","AIMS


Recombinant PEGylated human granulocyte colony-stimulating factor (pegfilgrastim) is indicated for the reduction of chemotherapy-induced neutropenia and prevention of febrile neutropenia. Biosimilar pegfilgrastim is expected to reduce the financial burden of this complication of chemotherapy. The aim of this study was to demonstrate biosimilarity between Sandoz biosimilar pegfilgrastim and its US- and EU-approved reference biologics.
METHODS


Phase I, randomized, double-blind, single-dose, 3-period, 6-sequence cross-over, multicentre study to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of Sandoz biosimilar pegfilgrastim with US- and EU-references in healthy adults.
RESULTS


Pharmacokinetic and pharmacodynamic similarity was demonstrated between the 3 biologics, as the 90% confidence interval for all primary pharmacokinetic and pharmacodynamic endpoint comparisons were contained within the predefined similarity margins of 0.80-1.25. Safety, immunogenicity and tolerability were also similar.
CONCLUSIONS


Sandoz biosimilar pegfilgrastim demonstrated pharmacokinetic and pharmacodynamic similarity to both US- and EU-reference biologics. No meaningful differences in safety, local tolerability and immunogenicity were identified.",2020,"No meaningful differences in safety, local tolerability, and immunogenicity were identified.","['healthy adults', 'healthy volunteers']","['Recombinant PEGylated human granulocyte colony-stimulating factor (pegfilgrastim', 'Sandoz biosimilar pegfilgrastim with US- and EU-references', 'pegfilgrastim biosimilar with its US- and EU-reference biologics', 'Biosimilar pegfilgrastim']","['pharmacokinetics, pharmacodynamics, safety, and immunogenicity', 'Pharmacokinetic (PK) and pharmacodynamic (PD) similarity', 'safety, local tolerability, and immunogenicity', 'Safety, immunogenicity, and tolerability']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]",,0.248203,"No meaningful differences in safety, local tolerability, and immunogenicity were identified.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellon', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Novartis, Princeton, NJ, USA.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Skerjanec', 'Affiliation': 'Sandoz AG, Novartis, Basel, Switzerland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Velinova', 'Affiliation': 'PRAHS, Groningen, The Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Dickerson', 'Affiliation': 'PRAHS, Lenexa, KS, USA.'}, {'ForeName': 'Ahad', 'Initials': 'A', 'LastName': 'Sabet', 'Affiliation': 'PRAHS, Salt Lake City, UT, USA.'}, {'ForeName': 'Ly', 'Initials': 'L', 'LastName': 'Ngo', 'Affiliation': 'PRAHS, Marlton, NJ, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': ""O'Reilly"", 'Affiliation': 'Celerion, Tempe, AZ, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Tomek', 'Affiliation': 'Celerion, Lincoln, NE, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Schussler', 'Affiliation': 'Novartis, Princeton, NJ, USA.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schier-Mumzhiu', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Sreekanth', 'Initials': 'S', 'LastName': 'Gattu', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Sven D', 'Initials': 'SD', 'LastName': 'Koch', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Schelcher', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Miryana', 'Initials': 'M', 'LastName': 'Dobreva', 'Affiliation': 'Sandoz, Novartis, Sofia, Bulgaria.'}, {'ForeName': 'Anca', 'Initials': 'A', 'LastName': 'Boldea', 'Affiliation': 'Sandoz Pharma Services Romania SRL, Novartis, Bucharest, Romania.'}, {'ForeName': 'Roumen', 'Initials': 'R', 'LastName': 'Nakov', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Gordon P', 'Initials': 'GP', 'LastName': 'Otto', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.14226']
1697,30827716,"Physical Therapy on Postoperative Day Zero Following Total Knee Arthroplasty: A Randomized, Controlled Trial of 394 Patients.","BACKGROUND


Surgeons have increasingly emphasized early mobilization as a way to facilitate discharge following total knee arthroplasty (TKA). The purpose of this study was to determine whether starting formal physical therapy (PT) the afternoon of postoperative day (POD) 0, instead of starting PT the morning of POD 1, could shorten hospital length of stay (LOS).
METHODS


Patients undergoing elective TKA with a planned minimum 1-night hospital stay were randomized to start formal PT the afternoon following surgery or the morning of POD 1. LOS in hours was the primary outcome. An a priori sample size calculation suggested that 394 patients were required to show a 4-hour difference between groups.
RESULTS


Out of 394 patients enrolled and randomized, 378 (95.9%) completed the study. The observed difference in hospital LOS was not large enough to be of clinical significance (intention-to-treat analysis: median of 32.0 hours for POD 0 PT vs 31.0 hours for POD 1 PT, P = .65; as-treated analysis: median of 31.0 hours for POD 0 PT vs 32.0 hours for POD 1 PT, P = .12). Similarly, the observed differences in satisfaction with inpatient PT (10.0 vs 10.0, P = .77), patient-reported readiness for discharge at time of discharge (10.0 vs 10.0, P = .97), and POD 0 pain (3.3 vs 4.0, P = .79) were not large enough to be of clinical significance.
CONCLUSION


While PT on the day of surgery has been suggested as one method to facilitate discharge following TKA, this randomized trial did not demonstrate clinically meaningful differences in hospital LOS or patient satisfaction when PT is initiated on the day of surgery vs on the morning after surgery.",2019,"Similarly, the observed differences in satisfaction with inpatient PT (10.0 vs 10.0, P = .77), patient-reported readiness for discharge at time of discharge (10.0 vs 10.0, P = .97), and POD 0 pain (3.3 vs 4.0, P = .79) were not large enough to be of clinical significance.
","['394 patients', '394 Patients', 'Total Knee Arthroplasty', '394 patients enrolled and randomized, 378 (95.9%) completed the study', 'Patients undergoing elective TKA with a planned minimum 1-night hospital stay']","['starting formal physical therapy (PT', 'Physical Therapy', 'LOS']","['POD 0 pain', 'hospital LOS', 'satisfaction with inpatient PT', 'hospital length of stay (LOS', 'Postoperative Day Zero']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]","[{'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}]",394.0,0.215244,"Similarly, the observed differences in satisfaction with inpatient PT (10.0 vs 10.0, P = .77), patient-reported readiness for discharge at time of discharge (10.0 vs 10.0, P = .97), and POD 0 pain (3.3 vs 4.0, P = .79) were not large enough to be of clinical significance.
","[{'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Bohl', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Tyler E', 'Initials': 'TE', 'LastName': 'Calkins', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Darrith', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Tori A', 'Initials': 'TA', 'LastName': 'Edmiston', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Nam', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Tad L', 'Initials': 'TL', 'LastName': 'Gerlinger', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Levine', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Della Valle', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.02.010']
1698,30797640,RNA-based adjuvant CV8102 enhances the immunogenicity of a licensed rabies vaccine in a first-in-human trial.,"BACKGROUND


We report the first-in-concept human trial of the safety, tolerability and immunogenicity when a novel TLR 7/8/RIG I agonist RNA-based adjuvant, CV8102, was administered alone or mixed with fractional doses of a licensed rabies vaccine (Rabipur®) as model antigen.
METHODS


The primary objective was to assess the safety and reactogenicity of various dose levels of CV8102 alone or mixed with Rabipur® in healthy 18-40 year-old male volunteers. A secondary objective was to assess the immune-enhancing potential of bedside-mixes of CV8102 with fractional doses of Rabipur® by measuring induction of rabies virus neutralising titres (VNTs).
RESULTS


Fifty-six volunteers received 50-100 μg CV8102 alone (n = 11), bedside-mixed CV8102 and Rabipur® (n = 20), or Rabipur® alone (n = 25; control). When given alone or mixed with Rabipur® CV8102 caused mostly Grade 1 or 2 local or systemic reactogenicity, but no related SAEs. As 100 µg CV8102 was associated with marked CRP increases further dose escalation was stopped. Combining 25-50 µg of CV8102 with fractional doses of Rabipur® significantly improved the kinetics of VNT responses; 50 µg CV8102 also improved the magnitude of VNT responses to 1/10 Rabipur® but caused severe but self-limiting influenza-like symptoms in 2 of 14 subjects.
CONCLUSIONS


Doses of 25 and 50 µg CV8102 appeared safe and with an acceptable reactogenicity profile while significantly enhancing the immunogenicity of fractional doses of rabies vaccine. EudraCT No. 2013-004514-18.",2019,"Combining 25-50 µg of CV8102 with fractional doses of Rabipur® significantly improved the kinetics of VNT responses; 50 µg CV8102 also improved the magnitude of VNT responses to 1/10 Rabipur® but caused severe but self-limiting influenza-like symptoms in 2 of 14 subjects.
","['healthy 18-40 year-old male volunteers', 'Fifty-six volunteers']","['rabies vaccine (Rabipur®', 'EudraCT', 'RNA-based adjuvant CV8102', 'bedside-mixed CV8102 and Rabipur®', 'CV8102 alone or mixed with Rabipur®', 'Rabipur® alone ', 'Rabipur®']","['kinetics of VNT responses', 'safety and reactogenicity', 'VNT responses']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0034496', 'cui_str': 'Rabies Vaccines'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1720722', 'cui_str': 'Mix'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",56.0,0.103617,"Combining 25-50 µg of CV8102 with fractional doses of Rabipur® significantly improved the kinetics of VNT responses; 50 µg CV8102 also improved the magnitude of VNT responses to 1/10 Rabipur® but caused severe but self-limiting influenza-like symptoms in 2 of 14 subjects.
","[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Doener', 'Affiliation': 'Curevac AG, Paul-Ehrlich-Strasse 15, 72076 Tübingen, Germany.'}, {'ForeName': 'Henoch S', 'Initials': 'HS', 'LastName': 'Hong', 'Affiliation': 'Curevac AG, Paul-Ehrlich-Strasse 15, 72076 Tübingen, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Meyer', 'Affiliation': 'CRS Clinical Research Services Mönchengladbach GmbH, 41061 Mönchengladbach, Germany.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Tadjalli-Mehr', 'Affiliation': 'Curevac AG, Schumannstrasse 27, 60325 Frankfurt, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Daehling', 'Affiliation': 'Curevac AG, Schumannstrasse 27, 60325 Frankfurt, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Heidenreich', 'Affiliation': 'Curevac AG, Paul-Ehrlich-Strasse 15, 72076 Tübingen, Germany.'}, {'ForeName': 'Sven D', 'Initials': 'SD', 'LastName': 'Koch', 'Affiliation': 'Curevac AG, Paul-Ehrlich-Strasse 15, 72076 Tübingen, Germany.'}, {'ForeName': 'Mariola', 'Initials': 'M', 'LastName': 'Fotin-Mleczek', 'Affiliation': 'Curevac AG, Paul-Ehrlich-Strasse 15, 72076 Tübingen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Gnad-Vogt', 'Affiliation': 'Curevac AG, Schumannstrasse 27, 60325 Frankfurt, Germany. Electronic address: Ulrike.Gnad-Vogt@curevac.com.'}]",Vaccine,['10.1016/j.vaccine.2019.02.024']
1699,30811543,Disseminating Tai Chi in the Community: Promoting Home Practice and Improving Balance.,"BACKGROUND AND OBJECTIVES


Falls among older adults is a pressing public health challenge. Considerable research documents that longer tai chi courses can reduce falls and improve balance. However, longer courses can be challenging to implement. Our goal was to evaluate whether a short 6-week modified tai chi course could be effective at reducing falls risk if older adults designed a personal home practice plan to receive a greater tai chi ""dose"" during the 6 weeks.
DESIGN


A 3-city wait-listed randomized trial was conducted. Habituation Intention and Social Cognitive Theories framed the ""coaching"" strategy by which participants designed practice plans. RE-AIM and Treatment Fidelity Frameworks were used to evaluate implementation and dissemination issues. Three advisory groups advised the study on intervention planning, implementation, and evaluation. To measure effectiveness, we used Centers for Disease Control and Prevention recommended measures for falls risk including leg strength, balance, and mobility and gait. In addition, we measured balance confidence and executive function.
RESULTS


Program Implementation resulted in large class sizes, strong participant retention, high program fidelity and effectiveness. Participants reported practicing an average of 6 days a week and more than 25 min/day. Leg strength, tandem balance, mobility and gait, balance confidence, and executive function were significantly better for the experimental group than control group.
CONCLUSION


The tai chi short course resulted in substantial tai chi practice by older adults outside of class as well as better physical and executive function. The course reach, retention, fidelity, and implementation across 3 cities suggest strong potential for implementation and dissemination of the 6-week course.",2020,"Leg strength, tandem balance, mobility and gait, balance confidence, and executive function were significantly better for the experimental group than control group.
",['older adults'],['tai chi'],"['large class sizes, strong participant retention, high program fidelity and effectiveness', 'Leg strength, tandem balance, mobility and gait, balance confidence, and executive function', 'balance confidence and executive function', 'course reach, retention, fidelity, and implementation', 'falls risk including leg strength, balance, and mobility and gait', 'substantial tai chi practice']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0557314', 'cui_str': 'Number of pupils in class (observable entity)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}]",,0.0343028,"Leg strength, tandem balance, mobility and gait, balance confidence, and executive function were significantly better for the experimental group than control group.
","[{'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Chewning', 'Affiliation': 'Social and Administrative Sciences Division, School of Pharmacy.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Hallisy', 'Affiliation': 'Doctor of Physical Therapy Program, Department of Family Medicine and Community Health.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Mahoney', 'Affiliation': 'Division of Geriatrics, Department of Medicine, School of Medicine and Public Health.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'Social and Administrative Sciences Division, School of Pharmacy.'}, {'ForeName': 'Nisaratana', 'Initials': 'N', 'LastName': 'Sangasubana', 'Affiliation': 'Sonderegger Research Center, School of Pharmacy.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Gangnon', 'Affiliation': 'Population Health, Department of Population Health Sciences.'}]",The Gerontologist,['10.1093/geront/gnz006']
1700,30806092,"Video delivery of toxicology educational content versus textbook for asynchronous learning, using acetaminophen overdose as a topic.","Objectives:  Advances in technology have brought with them innovations in delivery of medical educational content; for example, audio and video podcasts, flipped classroom learning, and e-books. These new modalities may be useful for delivery of content asynchronously, as an adjunct to traditional lecture-based and bedside clinical teaching. Here, we measured the differences in knowledge acquisition between medical students using a video-based content delivery method and students using a traditional method of asynchronous content delivery (a textbook chapter). We also measured student preferences regarding asynchronous content delivery.  Methods:  A 4.5-minute educational video was created by a content expert using VideoScribe software. Acetaminophen toxicity was selected as the sample topic. Survey Monkey software was used to create a pre-test, post-test, and to gather data regarding student preferences. Students were given the pre-test, then they were randomized to either read a chapter on acetaminophen overdose from an emergency medicine reference text or to view the video; they were then given the post-test and the preferences survey. The results were then categorized and analysed using descriptive statistics and linear regression.  Results:  Sixty-nine student responses were initiated, 14 of whom did not complete the full survey, leaving 55 students who were included in the final analysis. Fifteen first year, 27 second-year, 8 third-year, and 5 fourth-year students participated. Twenty-eight students were randomized to reading the textbook chapter, and 31 were randomized to view the video; 4 students in the textbook group did not finish the educational activity. On average, students who took the video training correctly answered 1.1 (95% CI: 0.1-2.2,  p  = .03) more questions correctly after adjusting for pretest score and year in medical school than those who read the textbook chapter. A preference for watching a video over reading a textbook chapter was expressed by 78.4% of students, while 98% of students either agreed or strongly agreed with the statement that they would be comfortable using the internet to learn new concepts. No students reported that they were very satisfied and 57% of students reported being satisfied reading the textbook chapter, while 93.3% were either satisfied or very satisfied viewing the video.  Conclusions:  Video delivery of educational content was associated with higher student satisfaction and relative improvement in score compared to textbook. Students overall expressed comfort using the internet and new technology to obtain new medical education. The authors were involved with creation of the video and quiz, which may confound results. Future exploration into retention of knowledge could be warranted.",2019,"A preference for watching a video over reading a textbook chapter was expressed by 78.4% of students, while 98% of students either agreed or strongly agreed with the statement that they would be comfortable using the internet to learn new concepts.","['Twenty-eight students', 'Sixty-nine student responses were initiated, 14 of whom did not complete the full survey, leaving 55 students who were included in the final analysis']",['textbook group did not finish the educational activity'],"['knowledge acquisition', 'student satisfaction', 'Acetaminophen toxicity']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0013652', 'cui_str': 'Educational Activities'}]","[{'cui': 'C0022750', 'cui_str': 'Knowledge Acquisition (Computer)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",28.0,0.0336979,"A preference for watching a video over reading a textbook chapter was expressed by 78.4% of students, while 98% of students either agreed or strongly agreed with the statement that they would be comfortable using the internet to learn new concepts.","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Vo', 'Affiliation': 'a Department of Emergency Medicine, Denver Health Medical Center , Denver , USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ledbetter', 'Affiliation': 'b Department of Biostatistics and Informatics, Colorado School of Public Health , Aurora , USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Zuckerman', 'Affiliation': 'c Department of Emergency Medicine, University of Colorado School of Medicine , Aurora , USA.'}]","Clinical toxicology (Philadelphia, Pa.)",['10.1080/15563650.2019.1574974']
1701,30855076,General practitioner endorsement of mail-out colorectal cancer screening: The perspective of nonparticipants.,"Despite the health and economic benefits associated with mail-out colorectal cancer (CRC) screening, participation in programs across the world is suboptimal. A letter from the recipient's general practitioner (GP) endorsing program participation has been shown to have a consistent, but modest, effect on screening uptake; however, the mechanisms by which GP endorsement is effective have not been investigated. The purpose of the present study was to evaluate the potential utility of GP endorsement letters or SMS in the context of facilitating bowel cancer screening in previous nonparticipants and to identify mechanisms underlying responses. A cross-section of nonparticipants in the Australian National Bowel Cancer Screening Program (N = 110) was randomly assigned to view a letter or SMS from a GP endorsing participation via an online survey. Ordinal responses reflecting effectiveness of, and influences on, GP endorsement were collected along with open questions regarding other potential endorsers. Percentages, means, and 95% confidence intervals were calculated and compared. Fifty-two percent of the sample agreed that GP endorsement would encourage their future participation. Responses did not differ between SMS and letter formats. Trust in the GP had significantly more influence on response to GP endorsement than the credibility or medical knowledge. Other health professionals and cancer survivors were commonly suggested as alternative sources of endorsement. Interventions to improve CRC screening participation could benefit from the routine implementation of GP endorsement from GPs, other trusted health professionals, or cancer survivors, particularly by encouraging people who forget or procrastinate over collecting a stool sample.",2020,Trust in the GP had significantly more influence on response to GP endorsement than the credibility or medical knowledge.,"['General practitioner endorsement of mail-out colorectal cancer screening', 'A cross-section of nonparticipants in the Australian National Bowel Cancer Screening Program (N = 110']",['GP endorsement letters or SMS'],[],"[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0346627', 'cui_str': 'Cancer of Intestines'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}]",[],110.0,0.0276375,Trust in the GP had significantly more influence on response to GP endorsement than the credibility or medical knowledge.,"[{'ForeName': 'Belinda C', 'Initials': 'BC', 'LastName': 'Goodwin', 'Affiliation': 'Institute for Resilient Regions, University of Southern Queensland, Springfield Central, QLD, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Crawford-Williams', 'Affiliation': 'Institute for Resilient Regions, University of Southern Queensland, Springfield Central, QLD, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ireland', 'Affiliation': 'Institute for Resilient Regions, University of Southern Queensland, Springfield Central, QLD, Australia.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'March', 'Affiliation': 'Institute for Resilient Regions, University of Southern Queensland, Springfield Central, QLD, Australia.'}]",Translational behavioral medicine,['10.1093/tbm/ibz011']
1702,30855087,"Development and evaluation of a consumer information resource, including Patient Decision Aid, for lung cancer screening: a quasi-experimental study.","Lung cancer screening of high-risk individuals with computed tomography is a promising intervention to reduce lung cancer mortality. Patient Decision Aids (PtDAs) may assist eligible individuals assess the risks and benefits associated with screening. Screening preference is high among lower-risk, screening-ineligible individuals and strategies are needed to reduce screening demand among this group. We developed and evaluated a resource comprising a recruitment pamphlet combined with either a PtDA for screening-eligible individuals or an education pamphlet for screening-ineligible individuals. Quasi-experimental pre-post pamphlet exposure design. Ever-smokers aged 55-80 years attending hospital outpatient clinics were invited. Among screening-eligible participants, the assessed outcome was change in score on the Decisional Conflict Scale (DCS). Among screening-ineligible participants, the assessed outcomes were change in screening preference. In the study 51% (55/107) of invited individuals participated, with mean ± standard deviation age 66.9 ± 6.4 years, 53% (29/55) male, and 65% (36/55) eligible for screening. Median (interquartile range) DCS among screening-eligible participants reduced from 28.9 (22.7-45.3) pre-PtDA to 25 (1.6-29.7) post-PtDA (p < .001), but there was no significant change in the proportion that reached the accepted threshold for decisional certainty (DCS < 25, 10/36 [28%] pre-exposure vs. 14/36 [39%] post-exposure, p = .1). Screening preference among screening-ineligible individuals reduced after viewing the screening-ineligible brochure (pre-exposure median of ""Prefer"" to post-exposure median of ""Unsure,"" p = .001). Our consumer information pamphlets about lung cancer screening may reduce decisional conflict and improve alignment of screening preference with eligibility.",2020,Our consumer information pamphlets about lung cancer screening may reduce decisional conflict and improve alignment of screening preference with eligibility.,"['Ever-smokers aged 55-80 years attending hospital outpatient clinics', 'Lung cancer screening of high-risk individuals with', 'for screening-ineligible individuals', 'In the study 51% (55/107) of invited individuals participated, with mean ± standard deviation age 66.9 ± 6.4 years, 53% (29/55) male, and 65% (36/55) eligible for screening']","['pamphlet combined with either a PtDA for screening-eligible individuals or an education pamphlet', 'computed tomography']","['Decisional Conflict Scale (DCS', 'decisional certainty', 'lung cancer mortality']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0029916', 'cui_str': 'Ambulatory Care Facilities, Hospital'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0439543', 'cui_str': 'Certainties (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.137271,Our consumer information pamphlets about lung cancer screening may reduce decisional conflict and improve alignment of screening preference with eligibility.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Manners', 'Affiliation': 'St John of God Midland Public and Private Hospital, Midland, Western Australia, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Pettigrew', 'Affiliation': 'School of Psychology, Curtin University, Bentley, Western Australia, Australia.'}, {'ForeName': 'Fiona R', 'Initials': 'FR', 'LastName': 'Lake', 'Affiliation': 'Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Piccolo', 'Affiliation': 'St John of God Midland Public and Private Hospital, Midland, Western Australia, Australia.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'McWilliams', 'Affiliation': 'Department of Respiratory Medicine, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Fraser J H', 'Initials': 'FJH', 'LastName': 'Brims', 'Affiliation': 'Curtin Medical School, Curtin University, Bentley, Western Australia, Australia.'}]",Translational behavioral medicine,['10.1093/tbm/ibz029']
1703,30809801,The Effect of Multidomain Lifestyle Intervention on Daily Functioning in Older People.,"OBJECTIVE


To investigate the effect of a 2-year multidomain lifestyle intervention on daily functioning of older people.
DESIGN


A 2-year randomized controlled trial (ClinicalTrials.gov, NCT01041989).
SETTING


Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability.
PARTICIPANTS


A total of 1260 older adults, with a mean age of 69 years at the baseline, who were at risk of cognitive decline.
INTERVENTION


A multidomain intervention, including simultaneous physical activity intervention, nutritional counseling, vascular risk monitoring and management, and cognitive training and social activity.
MEASUREMENTS


The ability to perform daily activities (activities of daily living [ADLs] and instrumental ADLs) and physical performance (Short Physical Performance Battery).
RESULTS


The mean baseline ADL score was 18.1 (SD = 2.6) points; the scale ranges from 17 (no difficulties) to 85 (total ADL dependence). During the 2-year intervention, the ADL disability score slightly increased in the control group, while in the intervention group, it remained relatively stable. Based on the latent growth curve model, the difference in the change between the intervention and control groups was -0.95 (95% confidence interval [CI] = -1.61 to -0.28) after 1 year and -1.20 (95% CI = -2.02 to -0.38) after 2 years. In terms of physical performance, the intervention group had a slightly higher probability of improvement (from score 3 to score 4; P = .041) and a lower probability of decline (from score 3 to scores 0-2; P = .043) for chair rise compared to the control group.
CONCLUSION


A 2-year lifestyle intervention was able to maintain the daily functioning of the at-risk older population. The clinical significance of these results in this fairly well-functioning population remains uncertain, but the study results hold promise that healthy eating, exercise, and cognitive and social activity may have favorable effects on functional independence in older people.",2019,"In terms of physical performance, the intervention group had a slightly higher probability of improvement (from score 3 to score 4; P = .041) and a lower probability of decline (from score 3 to scores 0-2; P = .043) for chair rise compared to the control group.
","['older people', 'Older People', 'A total of 1260 older adults, with a mean age of 69\u2009years at the baseline, who were at risk of cognitive decline']","['Multidomain Lifestyle Intervention', 'multidomain intervention', 'multidomain lifestyle intervention', 'simultaneous physical activity intervention, nutritional counseling, vascular risk monitoring and management, and cognitive training and social activity']","['Daily Functioning', 'daily activities (activities of daily living [ADLs] and instrumental ADLs) and physical performance (Short Physical Performance Battery', 'mean baseline ADL score', 'ADL disability score', 'chair rise']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C2607857'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",1260.0,0.0631968,"In terms of physical performance, the intervention group had a slightly higher probability of improvement (from score 3 to score 4; P = .041) and a lower probability of decline (from score 3 to scores 0-2; P = .043) for chair rise compared to the control group.
","[{'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Kulmala', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Tiia', 'Initials': 'T', 'LastName': 'Ngandu', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Havulinna', 'Affiliation': 'Ageing, Disability and Functioning Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Esko', 'Initials': 'E', 'LastName': 'Levälahti', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Lehtisalo', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'Division of Clinical Geriatrics, Center for Alzheimer Research, Care Sciences and Society (NVS), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Antikainen', 'Affiliation': 'Center for Life Course Health Research, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laatikainen', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Pauliina', 'Initials': 'P', 'LastName': 'Pippola', 'Affiliation': 'Seinäjoki Health Centre, Seinäjoki, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Peltonen', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Rauramaa', 'Affiliation': 'Kuopio Research Institute of Exercise Medicine, Kuopio, Finland.'}, {'ForeName': 'Hilkka', 'Initials': 'H', 'LastName': 'Soininen', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Strandberg', 'Affiliation': 'Center for Life Course Health Research, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Tuomilehto', 'Affiliation': 'Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Kivipelto', 'Affiliation': 'Division of Clinical Geriatrics, Center for Alzheimer Research, Care Sciences and Society (NVS), Karolinska Institutet, Stockholm, Sweden.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15837']
1704,30798790,Stepped approach to improving sexual function after gynaecological cancer: the SAFFRON feasibility RCT.,"BACKGROUND


Women affected by gynaecological cancer are often unaware of the sexual consequences of both the cancer and its treatment. Most do not receive appropriate advice or help to recover sexual function, and the effect on their sexuality may be profound, both physically and emotionally. However, several potential therapies can be effective in helping recover some sexual engagement and change self-perception around sex. A major initial challenge is informing and involving patients in an appropriate and sensitive manner, and a further issue is delivering therapies in busy gynaelogical oncology clinics. This study was conceived in response to a National Institute for Health Research (NIHR) Health Technology Assessment (HTA) call asking for proposals to improve sexual functioning in women treated for gynaecological cancer while taking into account associated issues of mood. Existing evidence-based therapies for improving sexual function after cancer treatment were adapted and placed within a 'stepped care' model for delivering these in the NHS setting. An assessment and treatment stepping algorithm was developed in parallel, both to assign women to a treatment level at assessment and to follow their progress session by session to advise on changing intervention level. The assessment tool was applied to all participants on the principle that the problem was sexual difficulty, not the cancer of origin.
PARTICIPANTS


Women aged > 18 years (with partners at their choice) treated for any gynaecological malignancy with surgery and/or chemotherapy and/or radiation at University College London Hospital or Bristol Gynaecological cancer centres, minimally 3 months post end of treatment, of any sexual orientation, with sexual function difficulties identified by three initial screening questions.
DESIGN


A feasibility two-arm, parallel-group randomised controlled pilot trial.
SETTING


Two NHS gynaecological cancer centres, one in London and one in Bristol.
INTERVENTIONS


A three-level stepped care intervention.
OBJECTIVE


To assess the feasibility of conducting a full-scale investigation of stepped therapy and indicate the potential benefits to patients and to the NHS generally.
PRIMARY OUTCOME MEASURES


Recruitment to study, proportion of women stepping up, number of usable data points of all measures and time points over length of trial, and retention of participants to end of trial.
RESULTS


Development of the intervention and accompanying algorithm was completed. The study was stopped before the recruitment stage and, hence, no randomisation, recruitment, numbers analysed, outcomes or harms were recorded.
LIMITATIONS


As the study did not proceed, the intervention and its accompanying algorithm have not been evaluated in practice, and the capacity of the NHS system to deliver it has not been examined.
CONCLUSIONS


None, as the study was halted.
FUTURE WORK


The intervention could be studied within a clinical setting; however, the experience of the study group points to the need for psychosocial studies in medical settings to establish pragmatic and innovative mechanisms to ensure adequate resource when extending staff clinical skills and time to deliver any new intervention for the duration of the trial.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN12010952 and ClinicalTrials.gov NCT02458001.
FUNDING


This project was funded by the NIHR HTA programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 5. See the NIHR Journals Library website for further project information.",2019,"The study was stopped before the recruitment stage and, hence, no randomisation, recruitment, numbers analysed, outcomes or harms were recorded.
","['Women aged >\u200918 years (with partners at their choice) treated for any gynaecological malignancy with surgery and/or chemotherapy and/or radiation at University College London Hospital or Bristol Gynaecological cancer centres, minimally 3 months post end of treatment, of any sexual orientation, with sexual function difficulties identified by three initial screening questions', 'National Institute for Health Research (NIHR', 'after gynaecological cancer', 'Two NHS gynaecological cancer centres, one in London and one in Bristol']",['Health Technology Assessment (HTA) call asking for proposals'],"['sexual functioning', 'Recruitment to study, proportion of women stepping up, number of usable data points of all measures and time points over length of trial, and retention of participants to end of trial', 'sexual function']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205949', 'cui_str': 'Sexual Orientation'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035168'}]","[{'cui': 'C0039423', 'cui_str': 'Technology Assessment, Health'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0454366', 'cui_str': 'Step ups (regime/therapy)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}]",,0.0482877,"The study was stopped before the recruitment stage and, hence, no randomisation, recruitment, numbers analysed, outcomes or harms were recorded.
","[{'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Gessler', 'Affiliation': 'Gynaecological Cancer Centre, University College London Hospitals, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'PRIMENT Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Lemma', 'Affiliation': 'Psychological Therapies Development Unit, Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Barber', 'Affiliation': 'Department of Statistical Science, University College London, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Dunning', 'Affiliation': 'Patient Advocate, London, UK.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Madden', 'Affiliation': 'Patient Advocate, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pilling', 'Affiliation': 'Research Department of Clinical Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'PRIMENT Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Research Department of Clinical Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Summerville', 'Affiliation': 'Gynaecological Cancer Centre, University College London Hospitals, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'MacDonald', 'Affiliation': 'Gynaecological Cancer Centre, University College London Hospitals, London, UK.'}, {'ForeName': 'Adeola', 'Initials': 'A', 'LastName': 'Olaitan', 'Affiliation': 'Gynaecological Cancer Centre, University College London Hospitals, London, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lanceley', 'Affiliation': ""Department of Women's Cancer, Institute for Women's Health, University College London, London, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/hta23060']
1705,30797084,Single-dose dalbavancin and patient satisfaction in an outpatient setting in the treatment of acute bacterial skin and skin structure infections.,"OBJECTIVES


Treatment of acute bacterial skin and skin structure infections (ABSSSIs) in the outpatient setting has potential advantages. We performed a subanalysis of outcomes for patients treated as outpatients versus inpatients with dalbavancin, a long-acting lipoglycopeptide, in a phase 3 clinical trial of ABSSSI.
METHODS


The study was a double-blind trial of patients with ABSSSI randomised to receive dalbavancin 1500 mg intravenously as a single dose or two doses (1000 mg followed by 500 mg a week later). The primary endpoint was ≥20% reduction in erythema at 48-72 h after the start of therapy. Patient satisfaction and preference for antibiotic treatment and care setting were measured using the 10-item Skin and Soft Tissue Infection (SSTI) questionnaire at Day 14.
RESULTS


A total of 698 patients were randomised (386 treated as outpatients and 312 as inpatients). Outpatients were more likely to be younger and to have major abscess or traumatic wound infection; inpatients were more likely to have cellulitis as the type of ABSSSI, to meet SIRS criteria and to have elevated plasma lactate at baseline. Efficacy and safety outcomes at 48-72 h, Days 14 and 28 were similar between patients treated in the outpatient and inpatient setting with either the single-dose or two-dose regimen. Outpatients reported significantly greater convenience and satisfaction with antibiotic treatment and care setting compared with inpatients (P < 0.001).
CONCLUSION


Single-dose dalbavancin is an effective treatment option for outpatients with ABSSSI and is associated with a high degree of patient treatment satisfaction and convenience.",2019,"Efficacy and safety outcomes at 48-72 h, Days 14 and 28 were similar between patients treated in the outpatient and inpatient setting with either the single-dose or two-dose regimen.","['acute bacterial skin and skin structure infections', 'patients treated as outpatients versus inpatients with dalbavancin, a long-acting lipoglycopeptide, in a phase 3 clinical trial of ABSSSI', 'patients with ABSSSI', '698 patients were randomised (386 treated as outpatients and 312 as inpatients', 'outpatients with ABSSSI']",['dalbavancin'],"['convenience and satisfaction with antibiotic treatment and care setting', '10-item Skin and Soft Tissue Infection (SSTI) questionnaire', 'Efficacy and safety outcomes', 'erythema']","[{'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1172636', 'cui_str': 'dalbavancin'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3883364', 'cui_str': 'Lipoglycopeptides'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}, {'cui': 'C4552483', 'cui_str': 'ABSSSI'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}]","[{'cui': 'C1172636', 'cui_str': 'dalbavancin'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0149778', 'cui_str': 'Soft Tissue Infection'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",698.0,0.0590926,"Efficacy and safety outcomes at 48-72 h, Days 14 and 28 were similar between patients treated in the outpatient and inpatient setting with either the single-dose or two-dose regimen.","[{'ForeName': 'Urania', 'Initials': 'U', 'LastName': 'Rappo', 'Affiliation': 'Allergan plc, 5 Giralda Farms, Madison, NJ 07940, USA. Electronic address: rappou01@gmail.com.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Gonzalez', 'Affiliation': 'Allergan plc, 5 Giralda Farms, Madison, NJ 07940, USA.'}, {'ForeName': 'Sailaja', 'Initials': 'S', 'LastName': 'Puttagunta', 'Affiliation': 'Allergan plc, 5 Giralda Farms, Madison, NJ 07940, USA.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Akinapelli', 'Affiliation': '11322 Town Walk Drive, Hamden, CT 06518, USA.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Keyloun', 'Affiliation': 'Allergan plc, 2525 Dupont Drive (T2-2P), Irvine, CA 92612, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Gillard', 'Affiliation': 'Allergan plc, 2525 Dupont Drive (T2-2P), Irvine, CA 92612, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Allergan plc, 5 Giralda Farms, Madison, NJ 07940, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Dunne', 'Affiliation': 'Allergan plc, 5 Giralda Farms, Madison, NJ 07940, USA.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2019.02.007']
1706,30840307,Effect of different doses of ketamine with low-dose rocuronium on intubation conditions in children: prospective randomized double blind trial.,"OBJECTIVE


The effect of ketamine on intubation condition, when used as an induction agent with low-dose rocuronium, is unknown. This study aimed to compare the effects of three doses of ketamine used with 0.3 mg/kg rocuronium and 1 µg/kg fentanyl on intubation conditions in children undergoing short elective surgery.
PATIENTS AND METHODS


The study was performed as a prospective, randomized double-blind clinical trial. A total of 60 children aged 2 to 12 years, who were scheduled for inguinal herniorrhaphy under general anesthesia, were randomly allocated into three groups on the basis of ketamine dose: 1 mg/kg (Group K1, n = 20), 1.5 mg/kg (Group K1.5, n = 20), and 2 mg/kg (Group K2, n = 20). The primary outcome was the intubation condition. Other assessments included hemodynamic data, recovery profile, adverse events in the postanesthetic care unit (PACU) and use of fentanyl as a rescue analgesic in the PACU were also assessed.
RESULTS


The occurrence of a clinically acceptable intubation condition increased with the use of an increased dose (≥ 1.5 mg/kg) (K1/K1.5/K2: 30%/65%/65%; p=0.038, for trends p=0.028). Hemodynamic data, recovery profile and adverse events in PACU showed no difference among groups. Fentanyl dose used in the PACU was higher in K1 than K2 and the number of patients requiring rescue analgesics in the PACU decreased in accordance with the dose of ketamine (K1/K1.5/K2: 30%/15%/0%; p=.031, for trends p=0.013).
CONCLUSIONS


Different intubation conditions were observed on the basis of ketamine dose used in conjunction with 0.3 mg/kg rocuronium and fentanyl 1 µg/kg. Ketamine dose ≥ 1.5 mg/kg with low-dose rocuronium should be used to improve intubation conditions in pediatrics.",2019,"Fentanyl dose used in the PACU was higher in K1 than K2 and the number of patients requiring rescue analgesics in the PACU decreased in accordance with the dose of ketamine (K1/K1.5/K2: 30%/15%/0%; p=.031, for trends p=0.013).
","['children', 'children undergoing short elective surgery', '60 children aged 2 to 12 years, who were scheduled for inguinal herniorrhaphy under general anesthesia']","['Fentanyl', 'ketamine', 'rocuronium and 1 µg/kg fentanyl', 'ketamine with low-dose rocuronium', 'rocuronium', 'Ketamine']","['intubation condition', 'intubation conditions', 'Hemodynamic data, recovery profile and adverse events', 'hemodynamic data, recovery profile, adverse events in the postanesthetic care unit (PACU) and use of fentanyl as a rescue analgesic in the PACU', 'acceptable intubation condition']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}]",60.0,0.551517,"Fentanyl dose used in the PACU was higher in K1 than K2 and the number of patients requiring rescue analgesics in the PACU decreased in accordance with the dose of ketamine (K1/K1.5/K2: 30%/15%/0%; p=.031, for trends p=0.013).
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, South Korea. lyrin01@gmail.com.'}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Chae', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ha', 'Affiliation': ''}, {'ForeName': 'I K', 'Initials': 'IK', 'LastName': 'Yi', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201902_17144']
1707,31704161,Cardiovascular risk and the implications for clinical practice of cardiovascular outcome trials in type 2 diabetes.,"Cardiovascular disease (CVD) is the primary cause of morbidity and mortality in patients with type 2 diabetes (T2D). This review examines the impact of cardiovascular outcome trials (CVOTs) on clinical practice. To date, all CVOTs have shown non-inferiority versus placebo (both added to standard of care) against a primary endpoint of 3- or 4-point major adverse cardiovascular event (MACE), confirming CV safety of these treatments. Additionally, some CVOTs have shown superiority to placebo against the same MACE endpoint, suggesting a cardioprotective action for these treatments. This is reflected in guideline updates, which primary care physicians should consider when personalizing treatments.",2020,"To date, all CVOTs have shown non-inferiority versus placebo (both added to standard of care) against a primary endpoint of 3- or 4-point major adverse cardiovascular event (MACE), confirming CV safety of these treatments.","['patients with type 2 diabetes (T2D', 'type 2 diabetes']",['placebo'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.166855,"To date, all CVOTs have shown non-inferiority versus placebo (both added to standard of care) against a primary endpoint of 3- or 4-point major adverse cardiovascular event (MACE), confirming CV safety of these treatments.","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Chilton', 'Affiliation': 'Division of Cardiology, University of Texas Health Science Center, San Antonio, TX, USA. Electronic address: chilton@uthscsa.edu.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Dungan', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Jay H', 'Initials': 'JH', 'LastName': 'Shubrook', 'Affiliation': 'Touro University California College of Osteopathic Medicine, Primary Care Department, Vallejo, CA, USA.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Center of Diabetes and Metabolism, Emory University, Atlanta, GA, USA.'}]",Primary care diabetes,['10.1016/j.pcd.2019.09.008']
1708,30630401,Mental Health Self-Directed Care Financing: Efficacy in Improving Outcomes and Controlling Costs for Adults With Serious Mental Illness.,"OBJECTIVE


Self-directed care allows individuals with disabilities and elderly persons to control public funds to purchase goods and services that help them remain outside institutional settings. This study examined effects on outcomes, service costs, and user satisfaction among adults with serious mental illness.
METHODS


Public mental health system clients were randomly assigned to self-directed care (N=114) versus services as usual (N=102) and assessed at baseline and 12 and 24 months. The primary outcome was self-perceived recovery. Secondary outcomes included psychosocial status, psychiatric symptom severity, and behavioral rehabilitation indicators. Mixed-effects random-regression analysis tested for longitudinal changes in outcomes between the two conditions. Differences in service costs were analyzed with negative binomial and zero-inflated negative binomial regression models.
RESULTS


Compared with the control group, self-directed care participants had significantly greater improvement over time in recovery, self-esteem, coping mastery, autonomy support, somatic symptoms, employment, and education. No between-group differences were found in total per-person service costs in years 1 and 2 or both years combined. However, self-directed care participants were more likely than control group participants to have zero costs for six of 12 individual services and to have lower costs for four. The most frequent nontraditional purchases were for transportation (21%), communication (17%), medical care (15%), residential (14%), and health and wellness needs (11%). Client satisfaction with mental health services was significantly higher among intervention participants, compared with control participants, at both follow-ups.
CONCLUSIONS


The budget-neutral self-directed care model achieved superior client outcomes and greater satisfaction with mental health care, compared with services as usual.",2019,"Client satisfaction with mental health services was significantly higher among intervention participants, compared with control participants, at both follow-ups.
","['individuals with disabilities and elderly persons', 'adults with serious mental illness', 'Adults With Serious Mental Illness', 'Public mental health system clients']",[],"['medical care', 'total per-person service costs', 'psychosocial status, psychiatric symptom severity, and behavioral rehabilitation indicators', 'service costs', 'Client satisfaction with mental health services', 'time in recovery, self-esteem, coping mastery, autonomy support, somatic symptoms, employment, and education', 'outcomes, service costs, and user satisfaction', 'self-perceived recovery']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]",[],"[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0337459', 'cui_str': 'Psychosocial status (social concept)'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3839861', 'cui_str': 'Medically Unexplained Symptoms'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",,0.0569583,"Client satisfaction with mental health services was significantly higher among intervention participants, compared with control participants, at both follow-ups.
","[{'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Cook', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago (UIC) (Cook, Burke-Miller, Jonikas, Hamilton, Norris, Markowitz, Bhaumik); TriWest Group, Boulder, Colorado (Shore); Beacon Health Options, Dallas (Ruckdeschel); Texas Health and Human Services Commission, Austin (Ferrara).'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Shore', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago (UIC) (Cook, Burke-Miller, Jonikas, Hamilton, Norris, Markowitz, Bhaumik); TriWest Group, Boulder, Colorado (Shore); Beacon Health Options, Dallas (Ruckdeschel); Texas Health and Human Services Commission, Austin (Ferrara).'}, {'ForeName': 'Jane K', 'Initials': 'JK', 'LastName': 'Burke-Miller', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago (UIC) (Cook, Burke-Miller, Jonikas, Hamilton, Norris, Markowitz, Bhaumik); TriWest Group, Boulder, Colorado (Shore); Beacon Health Options, Dallas (Ruckdeschel); Texas Health and Human Services Commission, Austin (Ferrara).'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Jonikas', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago (UIC) (Cook, Burke-Miller, Jonikas, Hamilton, Norris, Markowitz, Bhaumik); TriWest Group, Boulder, Colorado (Shore); Beacon Health Options, Dallas (Ruckdeschel); Texas Health and Human Services Commission, Austin (Ferrara).'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hamilton', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago (UIC) (Cook, Burke-Miller, Jonikas, Hamilton, Norris, Markowitz, Bhaumik); TriWest Group, Boulder, Colorado (Shore); Beacon Health Options, Dallas (Ruckdeschel); Texas Health and Human Services Commission, Austin (Ferrara).'}, {'ForeName': 'Brandy', 'Initials': 'B', 'LastName': 'Ruckdeschel', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago (UIC) (Cook, Burke-Miller, Jonikas, Hamilton, Norris, Markowitz, Bhaumik); TriWest Group, Boulder, Colorado (Shore); Beacon Health Options, Dallas (Ruckdeschel); Texas Health and Human Services Commission, Austin (Ferrara).'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Norris', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago (UIC) (Cook, Burke-Miller, Jonikas, Hamilton, Norris, Markowitz, Bhaumik); TriWest Group, Boulder, Colorado (Shore); Beacon Health Options, Dallas (Ruckdeschel); Texas Health and Human Services Commission, Austin (Ferrara).'}, {'ForeName': 'Anna Frost', 'Initials': 'AF', 'LastName': 'Markowitz', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago (UIC) (Cook, Burke-Miller, Jonikas, Hamilton, Norris, Markowitz, Bhaumik); TriWest Group, Boulder, Colorado (Shore); Beacon Health Options, Dallas (Ruckdeschel); Texas Health and Human Services Commission, Austin (Ferrara).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Ferrara', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago (UIC) (Cook, Burke-Miller, Jonikas, Hamilton, Norris, Markowitz, Bhaumik); TriWest Group, Boulder, Colorado (Shore); Beacon Health Options, Dallas (Ruckdeschel); Texas Health and Human Services Commission, Austin (Ferrara).'}, {'ForeName': 'Dulal', 'Initials': 'D', 'LastName': 'Bhaumik', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago (UIC) (Cook, Burke-Miller, Jonikas, Hamilton, Norris, Markowitz, Bhaumik); TriWest Group, Boulder, Colorado (Shore); Beacon Health Options, Dallas (Ruckdeschel); Texas Health and Human Services Commission, Austin (Ferrara).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201800337']
1709,30824339,Effects of gamma-hydroxybutyrate on neurophysiological correlates of performance and conflict monitoring.,"Performance and conflict monitoring (PM and CM) represent two essential cognitive abilities, required to respond appropriately to demanding tasks. PM and CM can be investigated using event-related brain potentials (ERP) and associated neural oscillations. Namely, the error-related negativity (ERN) represents a correlate of PM, whereas the N2 component reflects the process of CM. Both ERPs originate in the anterior cingulate cortex (ACC) and PM specifically has been shown to be susceptible to gamma-aminobutyric acid (GABA) A receptor activation. Contrarily, the specific effects of GABA B  receptor (GABA B R) stimulation on PM and CM are unknown. Thus, the effects of gamma-hydroxybutyrate (GHB; 20 and 35 mg/kg), a predominant GABA B R agonist, on behavioral and electrophysiological correlates of PM and CM were here assessed in 15 healthy male volunteers, using the Eriksen-Flanker paradigm in a randomized, double-blind, placebo-controlled, cross-over study. Electroencephalographic (EEG) data were analyzed in the time and time-frequency domains. GHB prolonged reaction times, without affecting error rates or post-error slowing. Moreover, GHB decreased ERN amplitudes and associated neural oscillations in the theta/alpha1 range. Similarly, neural oscillations associated with the N2 were reduced in the theta/alpha1 range, while N2 amplitude was conversely increased. Hence, GHB shows a dissociating effect on electrophysiological correlates of PM and CM. Reduced ERN likely derives from a GABA B R-mediated increase in dopaminergic signaling, disrupting the generation of prediction errors, whereas an enhanced N2 suggests an increased susceptibility towards external stimuli. Conclusively, GHB is the first drug reported, thus far, to have opposite effects on PM and CM, underlined by its unique electrophysiological signature.",2019,"Similarly, neural oscillations associated with the N2 were reduced in the theta/alpha1 range, while N2 amplitude was conversely increased.",['15 healthy male volunteers'],"['placebo', 'gamma-hydroxybutyrate', 'Performance and conflict monitoring (PM and CM', 'GABA B  receptor (GABA B R) stimulation', 'predominant GABA B R agonist', 'gamma-hydroxybutyrate (GHB']","['neurophysiological correlates of performance and conflict monitoring', 'Electroencephalographic (EEG) data', 'GHB decreased ERN amplitudes and associated neural oscillations', 'GHB prolonged reaction times', 'neural oscillations']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0052887', 'cui_str': 'GABA-B Receptor'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",15.0,0.0585166,"Similarly, neural oscillations associated with the N2 were reduced in the theta/alpha1 range, while N2 amplitude was conversely increased.","[{'ForeName': 'Dario A', 'Initials': 'DA', 'LastName': 'Dornbierer', 'Affiliation': 'Experimental and Clinical Pharmacopsychology, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, CH-8032 Zurich, Switzerland; Institute of Pharmacology and Toxicology, University of Zurich, Winterthurerstrasse 190, 8057 Zürich, Switzerland. Electronic address: dornbierer@pharma.uzh.ch.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kometer', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging Research Unit, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry Zurich, Lenggstrasse 31, 8032 Zurich, Switzerland.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Von Rotz', 'Affiliation': 'Experimental and Clinical Pharmacopsychology, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, CH-8032 Zurich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Studerus', 'Affiliation': 'Center for Gender Research and Early Detection, Kornhausgasse 7, 4051 Basel, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Gertsch', 'Affiliation': 'Institute of Biochemistry and Molecular Medicine, University of Bern, Bühlstrasse 28, 3012 Bern, Switzerland.'}, {'ForeName': 'M Salomé', 'Initials': 'MS', 'LastName': 'Gachet', 'Affiliation': 'Institute of Biochemistry and Molecular Medicine, University of Bern, Bühlstrasse 28, 3012 Bern, Switzerland.'}, {'ForeName': 'Franz X', 'Initials': 'FX', 'LastName': 'Vollenweider', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging Research Unit, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry Zurich, Lenggstrasse 31, 8032 Zurich, Switzerland; Neuroscience Center Zurich, University and ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Experimental and Clinical Pharmacopsychology, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, CH-8032 Zurich, Switzerland; Neuroscience Center Zurich, University and ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Oliver G', 'Initials': 'OG', 'LastName': 'Bosch', 'Affiliation': 'Experimental and Clinical Pharmacopsychology, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, CH-8032 Zurich, Switzerland.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Experimental and Clinical Pharmacopsychology, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, CH-8032 Zurich, Switzerland; Neuroscience Center Zurich, University and ETH Zurich, Zurich, Switzerland.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.02.004']
1710,30772298,A Group Randomized Intervention Trial Increases Participation in the School Breakfast Program in 16 Rural High Schools in Minnesota.,"BACKGROUND


Breakfast consumption is associated with better diet quality and healthier weights, yet many adolescents miss breakfast. Nationally, 17.1% of students participate in the School Breakfast Program (SBP). Only 10% of high school students participate.
OBJECTIVE


Our aim was to evaluate an environmental intervention to increase SBP participation in high schools.
DESIGN


A group randomized trial was carried out from 2012 to 2015.
PARTICIPANTS/SETTING


Ninth- and 10th-grade students enrolled in 16 rural schools in Minnesota (median 387 students) were randomized to intervention or control condition.
INTERVENTION


A school-based intervention that included two key components was implemented over a 12-month period. One component focused on increasing SBP participation by increasing student access to school breakfast through changes in school breakfast service practices (eg, serving breakfast from a grab-n-go cart in the atrium; expanding breakfast service times). The other component focused on promoting school breakfast through student-directed marketing campaigns.
MAIN OUTCOME MEASURE


Change in school-level participation in the SBP was assessed between baseline (among ninth and tenth graders) and follow-up (among tenth and eleventh graders). School meal and attendance records were used to assess change in school-level participation rates in the SBP.
STATISTICAL ANALYSES


The Wilcoxon test was used for analysis of difference in change in mean SBP participation rate by experimental group.
RESULTS


The median change in SBP participation rate between baseline and follow-up was 3% (interquartile range=13.5%) among the eight schools in the intervention group and 0.5% (interquartile range=0.7%) among the eight schools in the control group. This difference in change between groups was statistically significant (Wilcoxon test, P=0.03). The intervention effect increased throughout the intervention period, with change in mean SBP participation rate by the end of the school year reaching 10.3% (95% CI 3.0 to 17.6). However, among the intervention schools, the change in mean SBP participation rates was highly variable (range=-0.8% to 24.8%).
CONCLUSIONS


Interventions designed to improve access to the SBP by reducing environmental and social barriers have potential to increase participation among high school students.",2019,"The intervention effect increased throughout the intervention period, with change in mean SBP participation rate by the end of the school year reaching 10.3% (95% CI 3.0 to 17.6).","['16 rural schools in Minnesota (median 387 students', 'Nationally, 17.1% of students participate in the School Breakfast Program (SBP', '2012 to\xa02015', 'Ninth- and 10th-grade students', '16 Rural High Schools in Minnesota']","['environmental intervention', 'intervention or control condition', 'School Breakfast Program']","['mean SBP participation rates', 'median change in SBP participation rate', 'SBP participation', 'mean SBP participation rate', 'Change in school-level participation in the SBP']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0205443', 'cui_str': 'Ninth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0026118', 'cui_str': 'Situational Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0201604,"The intervention effect increased throughout the intervention period, with change in mean SBP participation rate by the end of the school year reaching 10.3% (95% CI 3.0 to 17.6).","[{'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Nanney', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Leduc', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hearst', 'Affiliation': ''}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Shanafelt', 'Affiliation': ''}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schroeder', 'Affiliation': ''}, {'ForeName': 'Katherine Y', 'Initials': 'KY', 'LastName': 'Grannon', 'Affiliation': ''}, {'ForeName': 'Martha Y', 'Initials': 'MY', 'LastName': 'Kubik', 'Affiliation': ''}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Caspi', 'Affiliation': ''}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Harnack', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2018.12.007']
1711,30799495,Development of a tablet app designed to improve African Americans' screening colonoscopy rates.,"Compared with other racial/ethnic groups, African Americans have the highest colorectal cancer (CRC) morbidity and mortality rates. It is critical to help improve African Americans' CRC prevention efforts in order to reduce the burden of CRC in this community. The aim of this study was to develop and field test a tablet app, called e-Motivate, designed to improve African Americans' screening colonoscopy rates. The e-Motivate app was field tested, using an iterative approach. The first version of the app, e-Motivate 1.0, was field tested on 20 African Americans over the age of 50. Participants engaged in a think aloud exercise and provided feedback regarding the app's usability and acceptability. The results of the first field test were used to modify the app and develop e-Motivate 2.0. The field test procedures were repeated on a new group of participants (N = 18). The results from the second field test were used to make final modifications to the app. Overall, participants responded positively to the app. Qualitative analyses showed that participants found the app to be easy to use and helpful. Furthermore, descriptive statistics revealed that participants found the app to be highly usable and acceptable, exceeding recommended benchmarks for usability and acceptability. Critiques of the app were used to modify and finalize the intervention. The results from the proposed study suggest that the e-Motivate app is highly feasible and acceptable. The next step in this line of research is to conduct a randomized clinical trial to formally test the efficacy of the e-Motivate app for improving screening colonoscopy rates among African Americans.",2020,"Furthermore, descriptive statistics revealed that participants found the app to be highly usable and acceptable, exceeding recommended benchmarks for usability and acceptability.","[""African Americans' screening colonoscopy rates"", 'African Americans', '20 African Americans over the age of 50']",[],"['screening colonoscopy rates', 'highest colorectal cancer (CRC) morbidity and mortality rates']","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C1882982', 'cui_str': 'Screening colonoscopy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",20.0,0.0196931,"Furthermore, descriptive statistics revealed that participants found the app to be highly usable and acceptable, exceeding recommended benchmarks for usability and acceptability.","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Miller', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Jamilia R', 'Initials': 'JR', 'LastName': 'Sly', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Kemi B', 'Initials': 'KB', 'LastName': 'Gaffney', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'Zhiye', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Henry', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Jandorf', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz014']
1712,30853250,"Efficacy and safety of intravenous ceftriaxone at home versus intravenous flucloxacillin in hospital for children with cellulitis (CHOICE): a single-centre, open-label, randomised, controlled, non-inferiority trial.","BACKGROUND


Outpatient parenteral antimicrobial therapy in children is common despite no evidence of its efficacy or safety from clinical trials. We aimed to compare the efficacy and safety of intravenous antibiotic therapy at home with that of standard treatment in hospital for children with moderate to severe cellulitis.
METHODS


The Cellulitis at Home or Inpatient in Children from the Emergency Department (CHOICE) trial was a randomised, controlled, non-inferiority trial in children aged 6 months to 18 years who presented to the emergency department at The Royal Children's Hospital (Melbourne, VIC, Australia) with uncomplicated moderate to severe cellulitis. Participants were randomly assigned to receive either intravenous ceftriaxone (50 mg/kg once daily) at home or intravenous flucloxacillin (50 mg/kg every 6 h) in hospital with web-based randomisation, stratified by age and periorbital cellulitis. The primary outcome was treatment failure, which was defined as no clinical improvement or occurrence of an adverse event, resulting in a change in empiric antibiotics within 48 h of the first dose. Secondary outcomes included adverse events and acquisition of antibiotic-resistant bacteria. Outcomes were assessed in all randomised participants with outcome data (intention-to-treat population) and in all individuals who received treatment as allocated and did not have any major protocol violations (per-protocol population). For home treatment to be non-inferior to hospital treatment, the difference between groups in the proportion of children with treatment failure in the intention-to-treat population had to be less than 15%. This trial is registered with ClinicalTrials.gov, number NCT02334124.
FINDINGS


Between Jan 9, 2015, and June 15, 2017, we screened 1135 children for eligibility, of whom 190 were randomly assigned to receive ceftriaxone at home (n=95) or flucloxacillin in hospital (n=95). The intention-to-treat analysis comprised 188 children (93 in the home group and 95 in the hospital group) because two children in the home group were found to be ineligible after randomisation and were excluded. Treatment failure occurred in two (2%) children in the home group and in seven (7%) children in the hospital group (risk difference -5·2%, 95% CI -11·3 to 0·8, p=0·088). In the per-protocol analysis, treatment failure occurred in one (1%) of 89 children in the home group and in seven (8%) of 91 children in the hospital group (-6·5%, -12·4 to -0·7). Fewer children treated at home than in hospital had an adverse event (two [2%] vs ten [11%]; p=0·048). There was no difference between groups in rates of nasal acquisition of meticillin-resistant Staphylococcus aureus or gastrointestinal acquisition of extended-spectrum β-lactamase-producing bacteria or Clostridium difficile after 3 months.
INTERPRETATION


Home treatment with intravenous ceftriaxone is not inferior to treatment in hospital with intravenous flucloxacillin for children with cellulitis. The standard of care for the intravenous treatment of uncomplicated cellulitis in children should be home or outpatient care when feasible.
FUNDING


The Royal Children's Hospital Foundation and Murdoch Children's Research Institute.",2019,"There was no difference between groups in rates of nasal acquisition of meticillin-resistant Staphylococcus aureus or gastrointestinal acquisition of extended-spectrum β-lactamase-producing bacteria or Clostridium difficile after 3 months.
","['188 children (93 in the home group and 95 in the hospital group) because two children in the home group were found to be ineligible after randomisation and were excluded', 'Between Jan 9, 2015, and June 15, 2017', ""children aged 6 months to 18 years who presented to the emergency department at The Royal Children's Hospital (Melbourne, VIC, Australia) with uncomplicated moderate to severe cellulitis"", 'hospital for children with cellulitis (CHOICE', '1135 children for eligibility, of whom 190', 'The Cellulitis at Home or Inpatient in Children from the Emergency Department', 'hospital for children with moderate to severe cellulitis', 'children with cellulitis']","['flucloxacillin', 'intravenous ceftriaxone', 'ceftriaxone at home (n=95) or flucloxacillin', 'intravenous antibiotic therapy', 'ceftriaxone']","['Treatment failure', 'clinical improvement or occurrence of an adverse event, resulting in a change in empiric antibiotics', 'adverse events and acquisition of antibiotic-resistant bacteria', 'treatment failure', 'Efficacy and safety', 'efficacy and safety', 'adverse event', 'rates of nasal acquisition of meticillin-resistant Staphylococcus aureus or gastrointestinal acquisition of extended-spectrum β-lactamase-producing bacteria or Clostridium difficile']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}]","[{'cui': 'C0016267', 'cui_str': 'flucloxacillin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0559680', 'cui_str': 'Intravenous antibiotic therapy (procedure)'}]","[{'cui': 'C0162643'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1444090', 'cui_str': 'Resistant bacteria'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0025643', 'cui_str': 'Penicillin, Dimethoxyphenyl'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}]",1135.0,0.282425,"There was no difference between groups in rates of nasal acquisition of meticillin-resistant Staphylococcus aureus or gastrointestinal acquisition of extended-spectrum β-lactamase-producing bacteria or Clostridium difficile after 3 months.
","[{'ForeName': 'Laila F', 'Initials': 'LF', 'LastName': 'Ibrahim', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Sandy M', 'Initials': 'SM', 'LastName': 'Hopper', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia; Emergency Department, The Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Orsini', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, VIC, Australia; Melbourne Children's Trials Centre, Melbourne, VIC, Australia.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Daley', 'Affiliation': ""Infectious Diseases Unit, Department of General Medicine, The Royal Children's Hospital, Melbourne, VIC, Australia; Microbiology Department, The Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia; Emergency Department, The Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Penelope A', 'Initials': 'PA', 'LastName': 'Bryant', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia; Infectious Diseases Unit, Department of General Medicine, The Royal Children's Hospital, Melbourne, VIC, Australia; Hospital-In-The-Home Department, The Royal Children's Hospital, Melbourne, VIC, Australia. Electronic address: penelope.bryant@rch.org.au.""}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30729-1']
1713,30833160,Immunogenicity and safety of measles-rubella vaccine co-administered with attenuated Japanese encephalitis SA 14-14-2 vaccine in infants aged 8 months in China: a non-inferiority randomised controlled trial.,"BACKGROUND


In China, measles-rubella vaccine and live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) are recommended for simultaneous administration at 8 months of age, which is the youngest recommended age for these vaccines worldwide. We aimed to assess the effect of the co-administration of these vaccines at 8 months of age on the immunogenicity of measles-rubella vaccine.
METHODS


We did a multicentre, open-label, non-inferiority, two-group randomised controlled trial in eight counties or districts in China. We recruited healthy infants aged 8 months who had received all scheduled vaccinations according to the national immunisation recommendations and who lived in the county of the study site. Enrolled infants were randomly assigned (1:1) to receive either measles-rubella vaccine and LJEV simultaneously (measles-rubella plus LJEV group) or measles-rubella vaccine alone (measles-rubella group). The primary outcome was the proportion of infants with IgG antibody seroconversion for measles 6 weeks after vaccination, and a secondary outcome was the proportion of infants with IgG antibody seroconversion for rubella 6 weeks after vaccination. Analyses included all infants who completed the study. We used a 5% margin to establish non-inferiority. This trial was registered at ClinicalTrials.gov (NCT02643433).
FINDINGS


1173 infants were assessed for eligibility between Aug 13, 2015, and June 10, 2016. Of 1093 (93%) enrolled infants, 545 were randomly assigned to the measles-rubella plus LJEV group and 548 to the measles-rubella group. Of the infants assigned to each group, 507 in the measles-rubella plus LJEV group and 506 in the measles-rubella group completed the study. Before vaccination, six (1%) of 507 infants in the measles-rubella plus LJEV group and one (<1%) of 506 in the measles-rubella group were seropositive for measles; eight (2%) infants in the measles-rubella plus LJEV group and two (<1%) in the measles-rubella group were seropositive for rubella. 6 weeks after vaccination, measles seroconversion in the measles-rubella plus LJEV group (496 [98%] of 507) was non-inferior to that in the measles-rubella group (499 [99%] of 506; difference -0·8% [90% CI -2·6 to 1·1]) and rubella seroconversion in the measles-rubella plus LJEV group (478 [94%] of 507) was non-inferior to that in the measles-rubella group (473 [94%] of 506 infants; difference 0·8% [90% CI -1·8 to 3·4]). There were no serious adverse events in either group and no evidence of a difference between the two groups in the prevalence of any local adverse event (redness, rashes, and pain) or systemic adverse event (fever, allergy, respiratory infections, diarrhoea, and vomiting). Fever was the most common adverse event (97 [19%] of 507 infants in the measles-rubella plus LJEV group; 108 [21%] of 506 infants in the measles-rubella group).
INTERPRETATION


The evidence of similar seroconversion and safety with co-administered LJEV and measles-rubella vaccines supports the co-administration of these vaccines to infants aged 8 months. These results will be important for measles and rubella elimination and the expansion of Japanese encephalitis vaccination in countries where it is endemic.
FUNDING


US Centers for Disease Control and Prevention, US Department of Health and Human Services; China-US Collaborative Program on Emerging and Re-emerging Infectious Diseases.",2019,"There were no serious adverse events in either group and no evidence of a difference between the two groups in the prevalence of any local adverse event (redness, rashes, and pain) or systemic adverse event (fever, allergy, respiratory infections, diarrhoea, and vomiting).","['Of 1093 (93%) enrolled infants, 545', '1173 infants were assessed for eligibility between Aug 13, 2015, and June 10, 2016', 'healthy infants aged 8 months who had received all scheduled vaccinations according to the national immunisation recommendations and who lived in the county of the study site', 'eight counties or districts in China', 'group and 506 in the measles-rubella group completed the study', 'group and 548 to the measles-rubella group', 'infants aged 8 months in China']","['measles-rubella vaccine and LJEV simultaneously (measles-rubella plus LJEV group) or measles-rubella vaccine alone (measles-rubella group', 'LJEV', 'measles-rubella plus LJEV', 'measles-rubella vaccine co-administered with attenuated Japanese encephalitis SA 14-14-2 vaccine']","['measles seroconversion', 'proportion of infants with IgG antibody seroconversion', 'prevalence of any local adverse event (redness, rashes, and pain) or systemic adverse event (fever, allergy, respiratory infections, diarrhoea, and vomiting', 'rubella seroconversion', 'serious adverse events', 'Fever', 'Immunogenicity and safety']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4517809', 'cui_str': 'Five hundred and forty-five'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0035923', 'cui_str': 'rubella, live attenuated'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0014057', 'cui_str': 'Viral Encephalitis, Japanese B'}, {'cui': 'C4277085', 'cui_str': 'SA-14-14-2 vaccine'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1173.0,0.180644,"There were no serious adverse events in either group and no evidence of a difference between the two groups in the prevalence of any local adverse event (redness, rashes, and pain) or systemic adverse event (fever, allergy, respiratory infections, diarrhoea, and vomiting).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China; Immunization Program Department, Lishui Prefectural Center for Disease Control and Prevention, Lishui, China.'}, {'ForeName': 'Susan Y', 'Initials': 'SY', 'LastName': 'Chu', 'Affiliation': 'Global Immunization Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Chenyan', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Wannemuehler', 'Affiliation': 'Global Immunization Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Shuyun', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Immunization Program Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China.'}, {'ForeName': 'Fubin', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Immunization Program Department, Hebei Provincial Center for Disease Control and Prevention, Shijiazhuang, China.'}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yuxi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Immunization Program Department, Baoding Prefectural Center for Disease Control and Prevention, Baoding, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Immunization Program Department, Ningbo Prefectural Center for Disease Control and Prevention, Ningbo, China.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China; Immunization Program Department, Lishui Prefectural Center for Disease Control and Prevention, Lishui, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Zuo', 'Affiliation': 'Immunization Program Department, Baoding Prefectural Center for Disease Control and Prevention, Baoding, China.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Rodewald', 'Affiliation': 'Global Immunization Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Qiyou', 'Initials': 'Q', 'LastName': 'Xiao', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zijian', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: wanghq@chinacdc.cn.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'An', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: anzj@chinacdc.cn.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30650-9']
1714,30827869,Effects of walk training with self-selected intensity on biochemical markers and anthropometric variables in women with obesity.,"To evaluate the effects of 12-weeks of walk training with self-selected intensity on lipid profile and anthropometric variables in women with obesity. Forty-eight women volunteers with obesity were randomly assigned into two training groups: self-selected walking group (SSWG; n=25) and control group (CG; n=23). There was improvement in biochemical markers only in the SSWG post-intervention (p<0.05), however no changes were verified in anthropometric variables (p>0.05). This study demonstrates that walking at self-selected intensity improved the lipid profile in women with obesity.",2019,"There was improvement in biochemical markers only in the SSWG post-intervention (p<0.05), however no changes were verified in anthropometric variables (p>0.05).","['Forty-eight women volunteers with obesity', 'women with obesity']","['walk training with self-selected intensity', 'self-selected walking group (SSWG']","['lipid profile and anthropometric variables', 'biochemical markers']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}]",48.0,0.025391,"There was improvement in biochemical markers only in the SSWG post-intervention (p<0.05), however no changes were verified in anthropometric variables (p>0.05).","[{'ForeName': 'João J', 'Initials': 'JJ', 'LastName': 'Garavelo', 'Affiliation': 'Universidade Estadual de Londrina (UEL), Londrina, Brazil.'}, {'ForeName': 'Leandro R', 'Initials': 'LR', 'LastName': 'Altimari', 'Affiliation': 'Universidade Estadual de Londrina (UEL), Londrina, Brazil.'}, {'ForeName': 'Juliano M', 'Initials': 'JM', 'LastName': 'Gabardo', 'Affiliation': 'Universidade Estadual de Londrina (UEL), Londrina, Brazil. Electronic address: julianomgabardo@gmail.com.'}, {'ForeName': 'Adalberto', 'Initials': 'A', 'LastName': 'Ferreira-Junior', 'Affiliation': 'Universidade Estadual de Londrina (UEL), Londrina, Brazil.'}, {'ForeName': 'Luis A G', 'Initials': 'LAG', 'LastName': 'Freitas', 'Affiliation': 'Universidade Estadual de Londrina (UEL), Londrina, Brazil.'}, {'ForeName': 'Cosme F', 'Initials': 'CF', 'LastName': 'Buzzachera', 'Affiliation': 'Universidade Norte do Paraná (UNOPAR), Londrina, Brazil.'}, {'ForeName': 'João V D C', 'Initials': 'JVDC', 'LastName': 'Esteves', 'Affiliation': 'Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Sergio G', 'Initials': 'SG', 'LastName': 'da Silva', 'Affiliation': 'Universidade Federal do Paraná (UFPR), Curitiba, Brazil.'}, {'ForeName': 'Solange M F', 'Initials': 'SMF', 'LastName': 'de Moraes', 'Affiliation': 'Universidade Estadual de Maringá (UEM), Maringá, Brazil.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2019.02.004']
1715,30817438,"The role of afferent input in postamputation pain: a randomized, double-blind, placebo-controlled crossover study.","In this randomized, double-blind, placebo-controlled crossover study, we investigated whether a peripheral nerve block could temporarily eliminate phantom and stump pain after amputation. Amputees with constant postamputation pain were included and randomized to receive a nerve block with lidocaine 2% with adrenaline or saline in a crossover design. Spontaneous phantom and stump pain and evoked responses were assessed at baseline and at fixed time-points until 120 minutes after lidocaine or saline injection. The primary outcome was the difference in absolute change between worst pain intensity, either phantom or stump pain, at baseline and at 30 minutes after lidocaine or saline injection. Twelve amputees were randomized and 9 patients were included in the analysis. The absolute change in median worst pain intensity between lidocaine and saline injection was -2.0 (interquartile range, -4.0 to 0.0) (n = 9, P = 0.12). Nine of 9 patients reported at least some pain relief after lidocaine injection compared with only 2 of 9 patients after saline injection (P = 0.02). Phantom pain intensity was significantly reduced after lidocaine compared with saline injection (P = 0.04), whereas there was no significant change in stump pain intensity between the 2 interventions (P = 0.17). In all 9 amputees, evoked responses were eliminated after lidocaine injection. Thus, our findings suggest that afferent input from the peripheral nervous system plays an important role in postamputation pain.",2019,Nine of 9 patients reported at least some pain relief after lidocaine injection compared with only 2 of 9 patients after saline injection (P = 0.02).,"['postamputation pain', 'Twelve amputees were randomized and 9 patients were included in the analysis', 'Amputees with constant postamputation pain']","['lidocaine', 'adrenaline or saline', 'placebo']","['absolute change between worst pain intensity, either phantom or stump pain', 'Phantom pain intensity', 'Spontaneous phantom and stump pain and evoked responses', 'median worst pain intensity', 'stump pain intensity', 'evoked responses', 'pain relief']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002695', 'cui_str': 'Amputees'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0282611', 'cui_str': 'Phantoms, Imaging'}, {'cui': 'C0002690', 'cui_str': 'Amputation Stumps'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4048296', 'cui_str': 'Phantom Pain'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",12.0,0.736907,Nine of 9 patients reported at least some pain relief after lidocaine injection compared with only 2 of 9 patients after saline injection (P = 0.02).,"[{'ForeName': 'Nina Stockfleth', 'Initials': 'NS', 'LastName': 'Buch', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ahlburg', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Haroutounian', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Niels Trolle', 'Initials': 'NT', 'LastName': 'Andersen', 'Affiliation': 'Section for Biostatistics, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Nanna Brix', 'Initials': 'NB', 'LastName': 'Finnerup', 'Affiliation': 'Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Nikolajsen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}]",Pain,['10.1097/j.pain.0000000000001536']
1716,30739019,A randomised phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in advanced squamous cell lung carcinoma (C-TONG1002).,"BACKGROUND


Nab-paclitaxel/carboplatin (nab-PC) and gemcitabine/carboplatin (GC) are the standard first-line chemotherapy in non-small cell lung carcinoma. Up to now, there is no head to head trial to compare nab-PC with GC in advanced squamous cell lung carcinoma.
PATIENTS AND METHODS


A multicentre randomised phase II trial was performed to compare the efficacy and safety for nab-PC with GC in previously untreated patients with advanced squamous cell lung carcinoma. The primary end-point was objective response rate (ORR). Progression-free survival (PFS), overall survival (OS), treatment-related adverse events and quality of life (QoL) were also analysed.
RESULTS


Totally 127 participants were eligible for this study (62/65 nab-PC/GC). Nab-PC has higher ORR than GC without statistical significance (42% versus 27%, P > 0.05). After a median follow-up of 14.5 months, both PFS and OS had no difference between the two arms (6.7 versus 5.8 months, hazard ratio [HR] 0.75, P = 0.143; 11.6 versus 14.4 months, HR 0.92, P = 0.846). Both regimens were well tolerated; however, more dose reduction occurred after cycle 2 in GC (27%) than in nab-PC (12%) (P < 0.05). Significant QoL improvement measured by trial outcome index was seen in nab-PC than in GC (P < 0.05).
CONCLUSIONS


The first-line nab-PC and GC had the same response, PFS, and OS in patients with advanced squamous cell lung carcinoma. Nab-PCM has advantage over GC in QoL improvement.
TRIAL REGISTRATION NUMBER


NCT01236716.",2019,Significant QoL improvement measured by trial outcome index was seen in nab-PC than in GC (P ,"['Totally 127 participants were eligible for this study (62/65 nab-PC/GC', 'non-small cell lung carcinoma', 'patients with advanced squamous cell lung carcinoma', 'advanced squamous cell lung carcinoma', 'advanced squamous cell lung carcinoma (C-TONG1002', 'previously untreated patients with advanced squamous cell lung carcinoma']","['nab-paclitaxel and carboplatin', 'nab-PC with GC', 'gemcitabine and carboplatin', 'Nab-paclitaxel/carboplatin (nab-PC) and gemcitabine/carboplatin (GC']","['tolerated', 'Progression-free survival (PFS), overall survival (OS), treatment-related adverse events and quality of life (QoL', 'hazard ratio', 'objective response rate (ORR', 'efficacy and safety']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0221910', 'cui_str': 'Squamous Cells'}, {'cui': 'C0684249', 'cui_str': 'Pulmonary carcinoma'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",127.0,0.0640148,Significant QoL improvement measured by trial outcome index was seen in nab-PC than in GC (P ,"[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan 2nd Road, Guangzhou 510080, People's Republic of China. Electronic address: hunterol@hotmail.com.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Fujian Province Cancer Hospital, 91 Fu Ma Road, Fuzhou, China. Electronic address: cheng671@sina.com.'}, {'ForeName': 'Jin-Ji', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan 2nd Road, Guangzhou 510080, People's Republic of China. Electronic address: yangjinji2003@163.com.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Nanjing General Hospital, 305 Zhong Shan Dong Road, Nanjing, China. Electronic address: yong_song6310@yahoo.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Province Cancer Hospital, 1018 Hu Guang Road, Changchun, China. Electronic address: jl.cheng@163.com.'}, {'ForeName': 'Gong-Yan', 'Initials': 'GY', 'LastName': 'Chen', 'Affiliation': 'Heilongjiang Province Cancer Hospital, 150 Ha Ping Road, Harbin, China. Electronic address: chengongyan@163.com.'}, {'ForeName': 'Hong-Hong', 'Initials': 'HH', 'LastName': 'Yan', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan 2nd Road, Guangzhou 510080, People's Republic of China. Electronic address: yanhonghong385@126.com.""}, {'ForeName': 'Xiao-Song', 'Initials': 'XS', 'LastName': 'Ben', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan 2nd Road, Guangzhou 510080, People's Republic of China. Electronic address: benxs@163.com.""}, {'ForeName': 'Bin-Chao', 'Initials': 'BC', 'LastName': 'Wang', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan 2nd Road, Guangzhou 510080, People's Republic of China. Electronic address: wbc_gz@hotmail.com.""}, {'ForeName': 'Chong-Rui', 'Initials': 'CR', 'LastName': 'Xu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan 2nd Road, Guangzhou 510080, People's Republic of China. Electronic address: xucr@hotmail.com.""}, {'ForeName': 'Ben-Yuan', 'Initials': 'BY', 'LastName': 'Jiang', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan 2nd Road, Guangzhou 510080, People's Republic of China. Electronic address: jiangben1000@126.com.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan 2nd Road, Guangzhou 510080, People's Republic of China. Electronic address: gzzhouqing@126.com.""}, {'ForeName': 'Hua-Jun', 'Initials': 'HJ', 'LastName': 'Chen', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan 2nd Road, Guangzhou 510080, People's Republic of China. Electronic address: chjdoctor@163.com.""}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan 2nd Road, Guangzhou 510080, People's Republic of China. Electronic address: syylwu@live.cn.""}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.01.007']
1717,30783854,"A Multicenter, Randomized, Controlled Trial Comparing Reinforced Staplers with Bare Staplers During Distal Pancreatectomy (HiSCO-07 Trial).","BACKGROUND


Although distal pancreatectomy (DP) using a reinforced stapler is expected to reduce PF, no multicenter RCT has been performed. To investigate whether reinforced staplers reduce the incidence of clinically relevant pancreatic fistula (PF) after DP compared with staplers without reinforcement.
METHODS


Between July 2016 and December 2017, patients scheduled for DP were enrolled in a multicenter, randomized, controlled trial (RCT) at nine hospitals in Hiroshima Japan. Patients were randomized either to reinforced stapler or bare stapler. The primary endpoint was incidence of clinically relevant PF. This RCT was registered with UMIN Clinical Trial Registry (UMIN000022341).
RESULTS


A total of 122 patients were assigned to reinforced stapler (n = 61) or bare stapler (n = 61), and 119 patients (61 reinforced stapler and 59 bare stapler) were analyzed. There was no significant difference in the incidence of clinically relevant PF between the reinforced stapler and bare stapler groups (16.3% vs. 27.1%, p = 0.15). Furthermore, the rates of major complication (16.3% vs. 18.6%, p = 0.74), postpancreatectomy hemorrhage (0% vs. 3.4%, p = 0.08), and median postoperative in-hospital days (19 days vs. 20 days, p = 0.78) did not differ between the two groups. Within a subset of 82 patients in whom the thickness of pancreatic transection line was less than 14 mm, a significant difference was found in the incidence of clinically relevant PF (4.5% vs. 21.0% in the reinforced stapler vs. bare stapler groups, respectively, p = 0.01).
CONCLUSIONS


Reinforced stapler for pancreatic transection during DP does not reduce the incidence of clinically relevant PF compared to stapler without reinforcement.",2019,"Furthermore, the rates of major complication (16.3% vs. 18.6%, p = 0.74), postpancreatectomy hemorrhage (0% vs. 3.4%, p = 0.08), and median postoperative in-hospital days (19 days vs. 20 days, p = 0.78) did not differ between the two groups.","['Between July 2016 and December 2017', '122 patients']","['Reinforced Staplers with Bare Staplers', 'distal pancreatectomy (DP', 'reinforced stapler or bare stapler', 'reinforced stapler (n\u2009=\u200961) or bare stapler']","['postpancreatectomy hemorrhage', 'incidence of clinically relevant PF', 'thickness of pancreatic transection line', 'rates of major complication', 'incidence of clinically relevant pancreatic fistula (PF', 'median postoperative in-hospital days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0441062', 'cui_str': 'Stapler (physical object)'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy (procedure)'}]","[{'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0152060', 'cui_str': 'Transection (procedure)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",122.0,0.289744,"Furthermore, the rates of major complication (16.3% vs. 18.6%, p = 0.74), postpancreatectomy hemorrhage (0% vs. 3.4%, p = 0.08), and median postoperative in-hospital days (19 days vs. 20 days, p = 0.78) did not differ between the two groups.","[{'ForeName': 'Naru', 'Initials': 'N', 'LastName': 'Kondo', 'Affiliation': 'Department of Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Uemura', 'Affiliation': 'Department of Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Kenjiro', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Department of Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Kuroda', 'Affiliation': 'Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sudo', 'Affiliation': 'Department of Surgery, Kure Medical Center and Chugoku Cancer Center, Kure, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Hadano', 'Affiliation': 'Department of Surgery, Kure Medical Center and Chugoku Cancer Center, Kure, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Matstukawa', 'Affiliation': 'Department of Gastroenterological Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Satoh', 'Affiliation': 'Department of Gastroenterological Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Sasaki', 'Affiliation': 'Department of Surgery, Hiroshima General Hospital, Hatsukaichi, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Surgery, Onomichi General Hospital, Onomichi, Japan.'}, {'ForeName': 'Saburo', 'Initials': 'S', 'LastName': 'Fukuda', 'Affiliation': 'Department of Surgery, Chugoku Rosai Hospital, Kure, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Oshita', 'Affiliation': 'Department of Gastroenterological Surgery, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Nakashima', 'Affiliation': 'Department of Surgery, Hiroshima City Asa Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Surgery, Hiroshima Memorial Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ohdan', 'Affiliation': 'Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Murakami', 'Affiliation': 'Department of Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan. mura777@hiroshima-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgical oncology,['10.1245/s10434-019-07222-0']
1718,30779061,Comparison between antimicrobial-coated sutures and uncoated sutures for the prevention of surgical site infections in plastic surgery: a double blind control trial.,"OBJECTIVE


Surgical site infection (SSI) produces considerable morbidity and increases health care costs. One of its causes is microbial adherence to the surgical sutures surface. A strategy to avoid microbial colonization is the use of antimicrobial-impregnated sutures. Recently absorbable sutures treated with chlorhexidine (CHX) have been developed. Our study purpose was to compare CHX-coated and uncoated suture in elective plastic surgery.
PATIENTS AND METHODS


We conducted a randomized, double-blind, single-centre controlled trial of 18 patients undergoing elective bilateral mammary surgery and 18 patients undergoing skin lesions removals. Patients were divided into 2 groups receiving antibacterial-coated (study group) and uncoated (controlled group) sutures for wound closure. Patients were evaluated for scar results and signs of SSIs were monitored over a period of 30 days (or 1 year in case of prosthetic surgery). Statistical comparison was performed using dependent t-tests for paired samples.
RESULTS


For patients undergoing mammary surgery, based on Vancouver Scale, there were no significant differences between the two groups. We noticed that in 8 patients the vertical scars belonging to the control group were larger than the contralateral 8 vertical sutures belonging to the study group. For patients undergoing skin surgery, surgical wounds treated with uncoated sutures were significantly more erythematous than the ones belonging to the study group (Media: 0,8333% vs. 1,5556%, respectively; standard deviation: 9,235 vs. 0,6157; 95%; p=0.0092).
CONCLUSIONS


No wounds infection was reported between the two groups. Based on our experience, we conclude that the use of CHX-coated sutures should be considered in case of inflamed lesions removal. Further studies are needed to validate our results.",2019,No wounds infection was reported between the two groups.,"['and 18 patients undergoing skin lesions removals', '18 patients undergoing', 'plastic surgery']","['CHX-coated sutures', 'chlorhexidine (CHX', 'elective bilateral mammary surgery', 'CHX-coated and uncoated suture', 'antimicrobial-coated sutures and uncoated sutures', 'antibacterial-coated (study group) and uncoated (controlled group) sutures for wound closure']","['wounds infection', 'scar results and signs of SSIs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0191322', 'cui_str': 'Excision of lesion of skin (procedure)'}, {'cui': 'C0038911', 'cui_str': 'Surgery, Plastic'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}]","[{'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0311392', 'cui_str': 'Sign'}]",18.0,0.118994,No wounds infection was reported between the two groups.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Carella', 'Affiliation': 'Department of General Surgery, Plastic Surgery ""P. Valdoni"", Policlinico Umberto I, Sapienza University of Rome, Rome, Italy. carellasara@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fioramonti', 'Affiliation': ''}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Onesti', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Scuderi', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201902_16982']
1719,30779100,Role of phase angle in the evaluation of effect of an immuno-enhanced formula in post-surgical cancer patients: a randomized clinical trial.,"OBJECTIVE


Neoplastic disease is frequently associated with poor nutritional status or severe malnutrition. Diet and nutritional intervention are becoming increasingly important for prognosis and quality of life in cancer patients. Accessible and repeatable tools for assessing nutritional status with body composition techniques seems to be fundamental. The aim of this study was to evaluate the effects of immunonutrition on body composition parameters, inflammatory response and nutritional status in patients at stage III of head and neck squamous carcinoma (HNSCC).
PATIENTS AND METHODS


In our work, 50 malnourished subjects with HNSCC staging III were recruited and treated with oral diet (OD) or enteral nutrition (EN). Patient under EN followed, for the first three days, enteral standard nutrition (ESN) and then enteral immunonutrition (EIN). Nutrition state was evaluated on days 0, 3, and 8 through body composition and biochemical analyses.
RESULTS


After 8 days, the EIN treatment showed a significant improvement in phase angle, pre-albumin, retinol binding protein and transferrin compared to the OD treatment.
CONCLUSIONS


Our results showed that immunonutrition treatment improves the nutritional status of neoplastic patients, supporting chemotherapy. The phase angle is not only a predictor of cancer survival, but has also proved to be useful in the surveillance of nutritional status improvement as well as biochemical indices.",2019,"After 8 days, the EIN treatment showed a significant improvement in phase angle, pre-albumin, retinol binding protein and transferrin compared to the OD treatment.
","['post-surgical cancer patients', 'cancer patients', '50 malnourished subjects with HNSCC staging III', 'patients at stage III of head and neck squamous carcinoma (HNSCC']","['oral diet (OD) or enteral nutrition (EN', 'immunonutrition', 'immuno-enhanced formula', 'Diet and nutritional intervention', 'enteral standard nutrition (ESN) and then enteral immunonutrition (EIN']","['cancer survival', 'body composition parameters, inflammatory response and nutritional status', 'Nutrition state', 'phase angle, pre-albumin, retinol binding protein and transferrin']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C1446172', 'cui_str': 'Retinol binding protein measurement (procedure)'}, {'cui': 'C0040679', 'cui_str': 'beta-1 Metal-Binding Globulin'}]",50.0,0.022038,"After 8 days, the EIN treatment showed a significant improvement in phase angle, pre-albumin, retinol binding protein and transferrin compared to the OD treatment.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Di Renzo', 'Affiliation': 'Section of Clinical Nutrition and Nutrigenomic, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy. laura.di.renzo@uniroma2.it.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marchetti', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cioccoloni', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gratteri', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Capria', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Romano', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Soldati', 'Affiliation': ''}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Mele', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Merra', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cintoni', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'De Lorenzo', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201902_17027']
1720,30772898,Person-Centered Sexual Expression: Determining Preferences of Future Nursing Home Residents.,"BACKGROUND AND OBJECTIVES


Approaches to sexual expression in nursing homes are often devoid of person-centered components, such as resident choice. Little is known about residents' preferences for sexual and intimate expression across different situations. To evaluate future resident preferences, a convenience sample of 389 midlife and older adults in the United States were assessed for their perceptions of appropriateness of sexual and intimate activity among couples in nursing homes, given certain situational factors (e.g., cognitive impairment, relationship status, assent behaviors).
RESEARCH DESIGN AND METHODS


A randomized experimental vignette design was implemented to determine situational factors that influence future resident preferences for sexual expression in nursing homes. Data were analyzed via multilevel modeling, allowing for multiple vignette ratings to be nested among respondents.
RESULTS


Behavioral indications of assent, level of intimacy between the couple, and age of respondent affected respondents' ratings of appropriateness of sexual and intimate activities. Also, cognition and relationship levels interacted for more nuanced effects on activity appropriateness.
DISCUSSION AND IMPLICATIONS


Future resident preferences are often incongruent with attitudes and common practices for approaching sexual expression in nursing home settings. This marks a unique opportunity for person-centered policy development and implementation in the realm of sexual expression.",2020,"RESULTS


Behavioral indications of assent, level of intimacy between the couple, and age of respondent affected respondents' ratings of appropriateness of sexual and intimate activities.","['nursing homes', 'Future Nursing Home Residents', '389 midlife and older adults in the United States were assessed for their perceptions of appropriateness of sexual and intimate activity among couples in nursing homes, given certain situational factors (e.g., cognitive impairment, relationship status, assent behaviors']",[],[],"[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C4517752', 'cui_str': '389 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],[],,0.0293967,"RESULTS


Behavioral indications of assent, level of intimacy between the couple, and age of respondent affected respondents' ratings of appropriateness of sexual and intimate activities.","[{'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Syme', 'Affiliation': 'Center on Aging, Kansas State University, Manhattan.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Johnson', 'Affiliation': 'Center for Research Methods and Data Analysis, University of Kansas, Lawrence.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Fager', 'Affiliation': 'Center for Research Methods and Data Analysis, University of Kansas, Lawrence.'}]",The Gerontologist,['10.1093/geront/gnz016']
1721,30348353,Prevalence and Indications for Unplanned Reoperations Following Index Surgery in the Adult Symptomatic Lumbar Scoliosis NIH-Sponsored Clinical Trial.,"STUDY DESIGN


Longitudinal cohort.
OBJECTIVE


To report on the prevalence and indications for unplanned reoperations following index surgery in the Adult Symptomatic Lumbar Scoliosis NIH-sponsored Clinical Trial.
SUMMARY OF BACKGROUND DATA


Reoperation following adult spinal deformity surgery exposes the patient to additional surgical risk, increases the cost of care, and decreases the potential cost-effectiveness of the intervention. Accurate data regarding the prevalence and indication for reoperation will facilitate future efforts to minimize risk.
METHODS


A total of 153 patients underwent adult spinal deformity surgery as part of the observational, randomized, or crossover groups and were eligible for two-year follow-up. Reoperations were meticulously tracked as part of the National Institutes of Health (NIH)-mandated serious adverse event (SAE) reporting. The primary indication for reoperation was obtained from the treating surgeon's operative report.
RESULTS


Thirty-two patients had one reoperation, two patients underwent two reoperations, and three patients underwent three reoperations. A total of 45 reoperations were performed in 37 patients. Eleven patients (7%) underwent reoperation within 90 days of the index surgery: two for superficial wound dehiscence, three for radiculopathy with screw removal, and six for acute proximal junctional failure (PJF). Four patients underwent reoperation for PJF more than 90 days from index surgery. Twenty-six patients underwent 28 reoperations for rod fracture/pseudoarthrosis.
CONCLUSION


In a consecutive series of adult spinal deformity surgery patients with meticulous follow-up, 24% of patients required an unplanned reoperation. The most common indication for reoperation was rod fracture/pseudoarthrosis, which occurred from 9 months to 3.7 years following the index surgery and accounted for 62% (28/45) of the reoperations. The second most common indication for reoperation was PJF, which occurred from 1 month to 1.6 years following index surgery and accounted for 22% (10/45) of the reoperations. As these complications will likely increase with longer follow-up, efforts to lower the rates of these complications are warranted.
LEVEL OF EVIDENCE


Level II.",2018,"Eleven patients (7%) underwent reoperation within 90 days of the index surgery: two for superficial wound dehiscence, three for radiculopathy with screw removal, and six for acute proximal junctional failure (PJF).","['adult spinal deformity surgery patients with meticulous follow-up, 24% of patients required an unplanned reoperation', 'Eleven patients (7%) underwent reoperation within 90 days of the index surgery: two for superficial wound dehiscence, three for radiculopathy with screw removal, and six for acute proximal junctional failure (PJF', 'Twenty-six patients underwent 28 reoperations for rod fracture/pseudoarthrosis', '153 patients underwent adult', 'Longitudinal cohort']","['spinal deformity surgery', 'Index Surgery']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0575157', 'cui_str': 'Deformity of spine (finding)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332804', 'cui_str': 'Superficial wound (morphologic abnormality)'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0205144', 'cui_str': 'Junctional (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0206427', 'cui_str': 'Retinal Rod'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0033785', 'cui_str': 'Pseudoarthrosis'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}]","[{'cui': 'C0575157', 'cui_str': 'Deformity of spine (finding)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",[],153.0,0.0529394,"Eleven patients (7%) underwent reoperation within 90 days of the index surgery: two for superficial wound dehiscence, three for radiculopathy with screw removal, and six for acute proximal junctional failure (PJF).","[{'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Crawford', 'Affiliation': 'Norton Leatherman Spine Center, 210 East Gray Street, Suite 900, Louisville, KY 40202, USA; Department of Orthopaedic Surgery, University of Louisville School of Medicine, 550 S. Jackson St., 1st Floor ACB, Louisville, KY 40202, USA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Glassman', 'Affiliation': 'Norton Leatherman Spine Center, 210 East Gray Street, Suite 900, Louisville, KY 40202, USA; Department of Orthopaedic Surgery, University of Louisville School of Medicine, 550 S. Jackson St., 1st Floor ACB, Louisville, KY 40202, USA.'}, {'ForeName': 'Leah Y', 'Initials': 'LY', 'LastName': 'Carreon', 'Affiliation': 'Norton Leatherman Spine Center, 210 East Gray Street, Suite 900, Louisville, KY 40202, USA. Electronic address: leah.carreon@nortonhealthcare.org.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Shaffrey', 'Affiliation': 'Department of Neurosurgery, University of Virginia, PO Box 800212, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Tyler R', 'Initials': 'TR', 'LastName': 'Koski', 'Affiliation': 'Department of Neurological Surgery, Northwestern University Feinberg School of Medicine, NMH/Arkes Family Pavilion Suite 2210, 676 N Saint Clair Street, Chicago, IL 60611, USA.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'Baldus', 'Affiliation': 'Department of Orthopaedic Surgery, Washington University School of Medicine, 660 S Euclid Ave, Campus Box 8233, St. Louis, MO 63110, USA.'}, {'ForeName': 'Keith H', 'Initials': 'KH', 'LastName': 'Bridwell', 'Affiliation': 'Department of Orthopaedic Surgery, Washington University School of Medicine, 660 S Euclid Ave, Campus Box 8233, St. Louis, MO 63110, USA.'}]",Spine deformity,['10.1016/j.jspd.2018.04.006']
1722,30251369,Pravastatin for Primary Prevention in Older Adults: Restricted Mean Survival Time Analysis.,"OBJECTIVES


To use restricted mean survival time, which summarizes treatment effects in terms of event-free time over a fixed time period, to evaluate the benefit of pravastatin therapy for primary prevention of cardiovascular disease in older adults.
DESIGN


Secondary analysis of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial-Lipid-Lowering Trial (ALLHAT-LLT).
SETTING


Ambulatory setting.
PARTICIPANTS


Individuals aged 65 and older (mean aged 71, 49% female) free of cardiovascular disease (N=2,867).
INTERVENTION


Pravastatin 40 mg/d (n=1,467) versus usual care (n=1,400).
MEASUREMENTS


We estimated the difference in RMST for total and coronary heart disease (CHD)-free survival between the pravastatin and usual care groups over the 6-year trial period and used parametric survival models to estimate RMST differences projected over 10 years.
RESULTS


Over 6 years, individuals treated with pravastatin lived (RMST 2,008.1 days), on average, 33.7 fewer days than those receiving usual care (RMST 2,041.8 days) (difference -33.7 days, 95% confidence interval (CI)=-67.0 to -0.5 days, p=.047). Pravastatin-treated individuals lived RMST 2,088.1 days), on average, 18.7 more days free of CHD over 6 years than those receiving usual care (RMST 2,069.4 days), but this difference was not statistically significant (difference 18.7 days, 95% CI=-10.4-47.8 days, p=.21). The 10-year projection showed that pravastatin-treated individuals would live 108.1 fewer days (95% CI=-204.5 to -14.1, p=.03) than those receiving usual care, although treated individuals would gain 77.9 days (95% CI=3.8-159.6, p=.046) of CHD-free survival.
CONCLUSION


RMST provides an intuitive and explicit way to express the effect of pravastatin therapy on CHD-free and overall survival in older adults free of cardiovascular disease. This measure allows a more personalized interpretation than hazard ratios of the benefits and risks of a medical intervention for decision-making.",2018,"Pravastatin-treated individuals lived RMST 2,088.1 days), on average, 18.7 more days free of CHD over 6 years than those receiving usual care (RMST 2,069.4 days), but this difference was not statistically significant (difference 18.7 days, 95% CI=-10.4-47.8 days, p=.21).","['Individuals aged 65 and older (mean aged 71, 49% female) free of cardiovascular disease (N=2,867', 'Ambulatory setting', 'Older Adults', 'older adults']","['Pravastatin', 'Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial-Lipid-Lowering Trial (ALLHAT-LLT', 'pravastatin', 'RMST', 'Pravastatin 40 mg/d (n=1,467) versus usual care (n=1,400', 'pravastatin therapy']","['CHD-free and overall survival', '10-year projection', 'mean survival time', 'RMST for total and coronary heart disease (CHD)-free survival']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033363', 'cui_str': 'Projection'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}]",,0.183567,"Pravastatin-treated individuals lived RMST 2,088.1 days), on average, 18.7 more days free of CHD over 6 years than those receiving usual care (RMST 2,069.4 days), but this difference was not statistically significant (difference 18.7 days, 95% CI=-10.4-47.8 days, p=.21).","[{'ForeName': 'Ariela R', 'Initials': 'AR', 'LastName': 'Orkaby', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Veterans Affairs Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Rich', 'Affiliation': 'Division of Cardiology, Department of Medicine, School of Medicine, Washington University, St Louis, Missouri.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Department of Biostatistics, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Eliah', 'Initials': 'E', 'LastName': 'Lux', 'Affiliation': 'Division of Gerontology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Lee-Jen', 'Initials': 'LJ', 'LastName': 'Wei', 'Affiliation': 'Department of Biostatistics, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Division of Gerontology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15509']
1723,32408153,Safety and feasibility of various fasting-mimicking diets among people with multiple sclerosis.,"BACKGROUND


Fasting-mimicking diets have shown promise in experimental autoimmune encephalitis and are currently being investigated among people with multiple sclerosis (MS). Ensuring adherence to diet changes is critical to determining the efficacy of such interventions.
OBJECTIVE


Our primary aim was to evaluate the safety and feasibility of several fasting-mimicking diets and investigate whether various levels of clinical support improve diet adherence among people with MS. Secondarily, this study evaluated the impact of fasting-mimicking diets on weight and patient-reported outcomes (PROs).
METHODS


We conducted three pilot studies (two randomized controlled for 6 months; one randomized with transition to single arm) restricting either the amount or timing of calorie intake over 24 or 48 weeks. Interventions included calorie restriction (daily or intermittently) or time-restricted feeding. Adherence measures varied across studies but were collected at study visits along with weight and PRO data.
RESULTS


A total of 90 participants enrolled; 70 completed the studies, with no serious adverse events reported. Overall adherence to the calorie restriction diets was poor. When participants were tasked with maintaining a diet in a pragmatic setting, neither previously completed intense clinical support and education, nor weekly electronic communication throughout the diet period appeared to improve diet adherence. Participants who were able to adhere to a calorie restriction diet predictably lost weight. In contrast to calorie restriction, adherence to a time-restricted feeding (TRF) diet was relatively good. No statistically significant changes in PROs were observed in an intention-to-treat analysis.
CONCLUSION


The role diet may play in clinical outcomes in MS remains unknown, as class I evidence is lacking. Diet adherence remains a primary barrier to the feasible conduct of large, randomized controlled diet trials. Strict adherence to a TRF dietary change may be more feasible than calorie restriction and should be considered in future fasting-mimicking diet trials. ClinicalTrials.gov Registry:A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis - NCT02647502. A Pragmatic Trial of Dietary Programs in People with Multiple Sclerosis (MS) - NCT02846558.",2020,"No statistically significant changes in PROs were observed in an intention-to-treat analysis.
","['people with MS', 'Participants who were able to adhere to a calorie restriction diet predictably lost weight', 'people with multiple sclerosis (MS', 'people with multiple sclerosis', 'People with Multiple Sclerosis (MS) - NCT02846558', 'A total of 90 participants enrolled; 70 completed the studies, with no serious adverse events reported']","['Dietary Programs', 'various fasting-mimicking diets', 'Intermittent Calorie Restriction', 'several fasting-mimicking diets']","['PROs', 'calorie restriction (daily or intermittently) or time-restricted feeding', 'Overall adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",90.0,0.0618671,"No statistically significant changes in PROs were observed in an intention-to-treat analysis.
","[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Roman', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State. Electronic address: sroman6@jhmi.edu.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beier', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Mowry', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102149']
1724,30735919,Phase II randomised study of maintenance treatment with bevacizumab or bevacizumab plus metronomic chemotherapy after first-line induction with FOLFOXIRI plus Bevacizumab for metastatic colorectal cancer patients: the MOMA trial.,"BACKGROUND


Alternating induction and maintenance phases is a common strategy in metastatic colorectal cancer (mCRC). Metronomic chemotherapy (metroCT) may represent a well-tolerated chemotherapy backbone for maximising bevacizumab effect during maintenance. The MOMA trial was designed to compare metroCT plus bevacizumab versus bevacizumab alone as maintenance following 4 months of induction with FOLFOXIRI plus bevacizumab.
PATIENTS AND METHODS


In this phase II study, patients with unresectable mCRC were randomised to receive up to 8 cycles of FOLFOXIRI plus bevacizumab, followed by bevacizumab (arm A) or the same regimen followed by bevacizumab plus metroCT (capecitabine 500 mg/three times per day and cyclophosphamide 50 mg/die, arm B) until disease progression. The primary end-point was progression-free survival (PFS). According to the Rubinstein and Korn's design, to detect a hazard ratio[HR] of 0.75 favouring arm B, with 1 sided-alpha and beta errors of 15% and 80%, 173 events and 222 patients were required.
RESULTS


Between May 2012 and March 2015, 232 patients, mostly with RAS (65%) or BRAF (9%) mutant tumours, were randomised in 16 Italian centres. At a median follow-up of 47.8 months, 210 and 164 progression and death events were registered. The primary end-point was not met. Median PFS was 10.3 and 9.4 months in arm B and A, respectively (HR: 0.94 [70% confidence interval {CI}: 0.82-1.09], p = 0.680). No significant differences were reported in terms of overall survival (OS) (median OS arm B/A: 22.5/28 months; HR: 1.16 [95%CI: 0.99-1.37], p = 0.336). Response rate with FOLFOXIRI plus bevacizumab was 63% (arm B/A: 58%/68%). In the liver-limited subgroup, the secondary resection rate was 49% (arm B/A: 45%/55%).
CONCLUSIONS


The addition of metroCT to maintenance with bevacizumab does not significantly improve PFS of mCRC patients. The activity of FOLFOXIRI plus bevacizumab is confirmed in a population with high prevalence of RAS/BRAF mutations treated with a 4-months induction.
TRIAL REGISTRATION


www.clinicaltrials.gov NCT02271464.",2019,Response rate with FOLFOXIRI plus bevacizumab was 63% (arm B/A: 58%/68%).,"['Between May 2012 and March 2015, 232 patients, mostly with RAS (65%) or BRAF (9%) mutant tumours', 'patients with unresectable mCRC', 'metastatic colorectal cancer (mCRC', 'metastatic colorectal cancer patients']","['bevacizumab', 'Metronomic chemotherapy (metroCT', 'FOLFOXIRI plus bevacizumab, followed by bevacizumab (arm A)\xa0or the same regimen followed by bevacizumab plus metroCT (capecitabine 500 mg/three times per day and cyclophosphamide', 'bevacizumab or bevacizumab plus metronomic chemotherapy', 'metroCT plus bevacizumab', 'FOLFOXIRI plus Bevacizumab', 'FOLFOXIRI plus bevacizumab']","['progression-free survival (PFS', 'death events', 'overall survival (OS', 'PFS', 'Response rate', 'secondary resection rate', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0984493', 'cui_str': 'capecitabine 500 MG'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.324533,Response rate with FOLFOXIRI plus bevacizumab was 63% (arm B/A: 58%/68%).,"[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Marmorino', 'Affiliation': 'Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bergamo', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, Veneto Institute of Oncology - IRCCS, Padova, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Aprile', 'Affiliation': 'Department of Oncology, University and General Hospital, Udine, Italy; Department of Oncology, General Hospital, ULSS8 Berica - East District, 36100, Vicenza, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Salvatore', 'Affiliation': 'U.O.C Oncologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli 8, 00168 Roma, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Masi', 'Affiliation': 'Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': ""Dell'Aquila"", 'Affiliation': 'Department of Medical Oncology, University Campus Biomedico, Rome, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Antoniotti', 'Affiliation': 'Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Murgioni', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, Veneto Institute of Oncology - IRCCS, Padova, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Allegrini', 'Affiliation': 'Unit of Medical Oncology, Livorno Hospital, Department of Medical Oncology, Azienda Toscana Nord Ovest, Livorno, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Borelli', 'Affiliation': 'Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Donatello', 'Initials': 'D', 'LastName': 'Gemma', 'Affiliation': 'Department of Medical Oncology, Hospital of Frosinone, Frosinone, Italy.'}, {'ForeName': 'Mariaelena', 'Initials': 'M', 'LastName': 'Casagrande', 'Affiliation': 'Department of Oncology, University and General Hospital, Udine, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Granetto', 'Affiliation': 'Department of Oncology, S. Croce and Carle Teaching Hospital, Cuneo, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Delfanti', 'Affiliation': 'Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Di Donato', 'Affiliation': 'Medical Oncology Department, Nuovo Ospedale-Santo Stefano, Prato, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Schirripa', 'Affiliation': 'Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy; Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, Veneto Institute of Oncology - IRCCS, Padova, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Sensi', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and Critical Area, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tonini', 'Affiliation': 'Department of Medical Oncology, University Campus Biomedico, Rome, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, Veneto Institute of Oncology - IRCCS, Padova, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Fontanini', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and Critical Area, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Clinical Trials Coordinating Center, Toscano Cancer Institute, University Hospital Careggi, Florence, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy. Electronic address: alfredo.falcone@med.unipi.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2018.12.028']
1725,32408245,"The impact of a three-phase video-assisted debriefing on nursing students' debriefing experiences, perceived stress and facilitators' practices: A mixed methods study.","BACKGROUND


As an integral part of simulation, debriefing helps learners to construct knowledge through reflecting, internalizing, and relating. Video-assisted debriefing (VAD) adds audio-visual captures and reviews to support traditional verbal debriefing (VD), but evidence evaluating its educational effects has been mixed, with limited attention focusing on its structure development.
AIMS


This study aimed to 1) investigate the effects of a three-phase VAD in enhancing nursing students' debriefing experiences and perceived stress compared to VD and 2) to explore its impact on facilitators' debriefing practices.
METHODS


A mixed-methods design was adopted. The quantitative phase involved a prospective controlled trial on 145 nursing students from a university in Singapore who were randomized into the intervention cluster (n = 72) and the control cluster (n = 73). The debriefing experience scale (DES), the stress visual analogue scale (Stress VAS), and the debriefing assessment for simulation in healthcare (DASH© student version) were used as outcome measures. For the qualitative component, a purposive sample of eight facilitators evaluated their own debriefing practices using the DASH© instructor version and each completed an open-ended question survey. Qualitative data were analyzed using content analysis.
RESULTS


Students from the intervention cluster significantly improved their debriefing experiences (p = 0.01), experienced comparable stress, and had better impressions of VAD facilitators' practices (p < 0.001) compared to those in the control cluster. Repeated VAD significantly reduced students' stress (p < 0.001). Students viewed the VAD facilitators as more effective than the VD facilitators. Three categories were derived from the qualitative comments: the act of debriefing, the crux of VAD, and debriefing for success.
CONCLUSION


The three-phase VAD significantly improved nursing students' debriefing experiences without adding extra stress. It also helped to improve facilitators' practices. Future research will benefit from exploring how experts facilitate the three-phase VAD ""on the ground"" and its effect on learning transfer and cost-effectiveness.",2020,"RESULTS


Students from the intervention cluster significantly improved their debriefing experiences (p = 0.01), experienced comparable stress, and had better impressions of VAD facilitators' practices (p < 0.001) compared to those in the control cluster.",['145 nursing students from a university in Singapore who were randomized into the intervention cluster (n\xa0=\xa072) and the control cluster (n\xa0=\xa073'],"['Video-assisted debriefing (VAD', 'three-phase video-assisted debriefing']","[""impressions of VAD facilitators' practices"", 'debriefing experience scale (DES), the stress visual analogue scale (Stress VAS), and the debriefing assessment for simulation in healthcare (DASH© student version', 'debriefing experiences']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",145.0,0.0300089,"RESULTS


Students from the intervention cluster significantly improved their debriefing experiences (p = 0.01), experienced comparable stress, and had better impressions of VAD facilitators' practices (p < 0.001) compared to those in the control cluster.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Sweden and Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: nurzh@nus.edu.sg.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: nurww@nus.edu.sg.'}, {'ForeName': 'S H L', 'Initials': 'SHL', 'LastName': 'Goh', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: nurghs@nus.edu.sg.'}, {'ForeName': 'X V', 'Initials': 'XV', 'LastName': 'Wu', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: nurwux@nus.edu.sg.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mörelius', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Sweden and School of Nursing and Midwifery, Edith Cowan University, Joondalup, Western Australia, Australia. Electronic address: e.morelius@ecu.edu.au.'}]",Nurse education today,['10.1016/j.nedt.2020.104460']
1726,30797722,"A mobile device application to reduce medication errors and time to drug delivery during simulated paediatric cardiopulmonary resuscitation: a multicentre, randomised, controlled, crossover trial.","BACKGROUND


Vasoactive drug preparation for continuous infusion in children is both complex and time consuming and places the paediatric population at higher risk than adults for medication errors. We developed a mobile device application (app) as a step-by-step guide for the preparation to delivery of drugs requiring continuous infusion. The app has been previously tested during simulation-based resuscitations in a previous single-centre trial. In this trial, our aim was to assess this app in various hospital settings.
METHODS


We did a prospective, multicentre, randomised, controlled, crossover trial to compare this app with an internationally used drug-infusion-rates table for the preparation of continuous drug infusion during standardised, simulation-based, paediatric post-cardiac arrest scenarios using a high-fidelity manikin. The scenarios were split into two study periods to assess the two preparation methods consecutively, separated by a washout distraction manoeuvre. Nurses in six paediatric emergency centres in Switzerland were randomly assigned (1:1) to start the scenario with either the app or the infusion-rates table and then complete the scenario using the other preparation method. The primary endpoint was the proportion of participants committing a medication error, which was defined as a deviation from the correct weight dose of more than 10%, miscalculation of the infusion rate, misprogramming of the infusion pump, or the inability to calculate drug dosage without calculation and guidance help from the study team. The medication error proportions observed with both preparation methods were compared by pooling both study periods, with paired data analysed using the unconditional exact McNemar test for dependent groups with a two-sided α level of 0·05. We did sensitivity analyses to investigate the carryover effect. This trial is registered with ClinicalTrials.gov, number NCT03021122.
FINDINGS


From March 1 to Dec 31, 2017, we randomly assigned 128 nurses to start the scenario using the app (n=64) or the infusion-rates table (n=64). Among the 128 drug preparations associated with each of the two methods, 96 (75%, 95% CI 67-82) delivered using the infusion-rates table were associated with medication errors compared with nine (7%, 3-13) delivered using the mobile app. Medication errors were reduced by 68% (95% CI 59-76%; p<0·0001) with the app compared with the table, as was the mean time to drug preparation (difference 148·2 s [95% CI 124·2-172·1], a 45% reduction; p<0·0001) and mean time to drug delivery (168·5 s [146·1-190·8], a 40% reduction; p<0·0001). Hospital size and nurses' experience did not modify the intervention effect. We detected no carryover effect.
INTERPRETATION


Critically ill children are particularly vulnerable to medication errors. A mobile app designed to help paediatric drug preparation during resuscitation with the aim to significantly reduce the occurrence of medication errors, drug preparation time, and delivery time could have the potential to change paediatric clinical practice in the area of emergency medicine.
FUNDING


Swiss National Science Foundation.",2019,"Medication errors were reduced by 68% (95% CI 59-76%; p<0·0001) with the app compared with the table, as was the mean time to drug preparation (difference 148·2 s [95% CI 124·2-172·1], a 45% reduction; p<0·0001) and mean time to drug delivery (168·5 s [146·1-190·8], a 40% reduction; p<0·0001).","['simulated paediatric cardiopulmonary resuscitation', 'Nurses in six paediatric emergency centres in Switzerland']",[],"['Medication errors', 'mean time to drug delivery', 'occurrence of medication errors, drug preparation time, and delivery time', 'proportion of participants committing a medication error', 'mean time to drug preparation']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]",[],"[{'cui': 'C4087540', 'cui_str': 'Medication errors (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0013164', 'cui_str': 'Drug Preparation'}]",128.0,0.242613,"Medication errors were reduced by 68% (95% CI 59-76%; p<0·0001) with the app compared with the table, as was the mean time to drug preparation (difference 148·2 s [95% CI 124·2-172·1], a 45% reduction; p<0·0001) and mean time to drug delivery (168·5 s [146·1-190·8], a 40% reduction; p<0·0001).","[{'ForeName': 'Johan N', 'Initials': 'JN', 'LastName': 'Siebert', 'Affiliation': ""Geneva Children's Hospital, Department of Paediatric Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland. Electronic address: johan.siebert@hcuge.ch.""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Ehrler', 'Affiliation': 'Division of Medical Information Sciences, Department of Radiology and Medical Informatics, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Combescure', 'Affiliation': 'Division of Clinical Epidemiology, Department of Health and Community Medicine, University of Geneva and Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lovis', 'Affiliation': 'Division of Medical Information Sciences, Department of Radiology and Medical Informatics, Geneva University Hospitals, Geneva, Switzerland; Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haddad', 'Affiliation': ""Geneva Children's Hospital, Department of Paediatric Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Hugon', 'Affiliation': ""Geneva Children's Hospital, Department of Paediatric Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Luterbacher', 'Affiliation': ""Geneva Children's Hospital, Department of Paediatric Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Lacroix', 'Affiliation': ""Geneva Children's Hospital, Department of Paediatric Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Gervaix', 'Affiliation': ""Geneva Children's Hospital, Department of Paediatric Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland; Faculty of Medicine, University of Geneva, Geneva, Switzerland.""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Manzano', 'Affiliation': ""Geneva Children's Hospital, Department of Paediatric Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland; Faculty of Medicine, University of Geneva, Geneva, Switzerland.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(19)30003-3']
1727,31260642,"Promoting Breast Cancer Surveillance: The EMPOWER Study, a Randomized Clinical Trial in the Childhood Cancer Survivor Study.","PURPOSE


The aim of the current study was to increase the uptake of screening mammography among high-risk women who were treated for a childhood cancer with chest radiotherapy.
PATIENTS AND METHODS


Two hundred four female survivors in the Childhood Cancer Survivor Study who were treated with chest radiotherapy with 20 Gy or greater, age 25 to 50 years, and without breast imaging in the past 24 months were randomly assigned 2:1 to receive a mailed informational packet followed by a tailored telephone-delivered brief motivational interview (intervention) versus an attention control. Primary outcome was the difference in the proportion of participants who completed a screening mammogram by 12 months as evaluated in an intent-to-treat analysis. Stratum-adjusted relative risk (RR) and 95% CI were estimated using the Cochran-Mantel-Haenszel method. Secondary outcomes included the completion of screening breast magnetic resonance imaging (MRI) and barriers to screening and moderating factors.
RESULTS


Women in the intervention group were significantly more likely than those in the control group to report a mammogram (45 [33.1%] of 136  v  12 [17.6%] of 68; RR, 1.9; 95% CI, 1.1 to 3.3). The intervention was more successful among women age 25 to 39 years (RR, 2.2; 95% CI, 1.1 to 4.7) than among those age 40 to 50 years (RR, 1.4; 95% CI, 0.6 to 3.2). The proportion of women who reported a breast MRI at 12 months was similar between the two groups: 16.2% (intervention) compared with 13.2% (control; RR, 1.2; 95% CI, 0.6 to 2.5). Primary barriers to completing a screening mammogram and/or breast MRI included lack of physician recommendation, deferred action by survivor, cost, and absence of symptoms.
CONCLUSION


Use of mailed materials followed by telephone-delivered counseling increased mammography screening rates in survivors at high risk for breast cancer; however, this approach did not increase the rate of breast MRI. Cost of imaging and physician recommendation were important barriers that should be addressed in future studies.",2019,"The intervention was more successful among women age 25 to 39 years (RR, 2.2; 95% CI, 1.1 to 4.7) than among those age 40 to 50 years (RR, 1.4; 95% CI, 0.6 to 3.2).","['Two hundred four female survivors in the Childhood Cancer Survivor Study who were treated with chest radiotherapy with 20 Gy or greater, age 25 to 50 years, and without breast imaging in the past 24 months', 'Promoting Breast Cancer Surveillance', 'high-risk women who were treated for a childhood cancer with chest radiotherapy', 'survivors at high risk for breast cancer']","['telephone-delivered counseling', 'mailed informational packet followed by a tailored telephone-delivered brief motivational interview (intervention) versus an attention control']","['uptake of screening mammography', 'completion of screening breast magnetic resonance imaging (MRI) and barriers to screening and moderating factors', 'rate of breast MRI', 'lack of physician recommendation, deferred action by survivor, cost, and absence of symptoms', 'breast MRI', 'mammography screening rates']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4047809', 'cui_str': 'At high risk for breast cancer'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C1641805', 'cui_str': 'Packet'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0203028', 'cui_str': 'Screening mammography (procedure)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",204.0,0.106373,"The intervention was more successful among women age 25 to 39 years (RR, 2.2; 95% CI, 1.1 to 4.7) than among those age 40 to 50 years (RR, 1.4; 95% CI, 0.6 to 3.2).","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Oeffinger', 'Affiliation': '1Duke University, Durham, NC.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Ford', 'Affiliation': '2Hunter College, City University of New York, New York, NY.'}, {'ForeName': 'Chaya S', 'Initials': 'CS', 'LastName': 'Moskowitz', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Chou', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Tara O', 'Initials': 'TO', 'LastName': 'Henderson', 'Affiliation': '5The University of Chicago, Chicago, IL.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Hudson', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Diller', 'Affiliation': '7Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ford', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Nidha Z', 'Initials': 'NZ', 'LastName': 'Mubdi', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Dayton', 'Initials': 'D', 'LastName': 'Rinehart', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Vukadinovich', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Gibson', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Anderson', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Elena B', 'Initials': 'EB', 'LastName': 'Elkin', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Garrett', 'Affiliation': '8University of Colorado School of Public Health, Denver, CO.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rebull', 'Affiliation': '9University of Vermont, Burlington, VT.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Leisenring', 'Affiliation': '10Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Leslie L', 'Initials': 'LL', 'LastName': 'Robison', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Armstrong', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00547']
1728,28976249,Walking and balance ability gain from two types of gait intervention in adult patients with chronic hemiplegic stroke: A pilot study.,"This study examined whether the walking and balance ability of adult patients with chronic hemiplegic stroke are associated differentially with the degree of gain after two types of gait intervention. Twenty-four subjects with hemiplegic stroke were enrolled in this randomized study. Each subject participated in one of two gait intervention strategies: gait training with auditory feedback caused by active weight bearing on the paralyzed side (experimental group; EG), or general gait intervention over the ground (control group; CG). The walking and balance abilities were assessed before and after gait intervention. Significant improvements in the 10-m walking test, functional gait assessment (FGA) score, and center of pressure (COP) path length were observed after gait training in both groups (p < 0.05). The EG showed a larger increase in the 10-m walking test, FGA score, and COP path length in the state of eyes opened and closed than the CG (18.2%, 27.0%, 24.8%, and 18.2%, respectively). The auditory feedback caused by active weight bearing on the paralyzed side appeared to be a more effective approach for improving the walking and balance ability in adult patients with hemiplegic stroke during walking training than general gait intervention.",2019,"The EG showed a larger increase in the 10-m walking test, FGA score, and COP path length in the state of eyes opened and closed than the CG (18.2%, 27.0%, 24.8%, and 18.2%, respectively).","['adult patients with hemiplegic stroke', 'adult patients with chronic hemiplegic stroke', 'Twenty-four subjects with hemiplegic stroke']","['gait intervention strategies: gait training with auditory feedback caused by active weight bearing on the paralyzed side (experimental group; EG), or general gait intervention over the ground (control group; CG', 'gait intervention', 'walking training than general gait intervention']","['walking and balance abilities', 'Walking and balance ability gain', '10-m walking test, functional gait assessment (FGA) score, and center of pressure (COP) path length', '10-m walking test, FGA score, and COP path length']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",24.0,0.0170699,"The EG showed a larger increase in the 10-m walking test, FGA score, and COP path length in the state of eyes opened and closed than the CG (18.2%, 27.0%, 24.8%, and 18.2%, respectively).","[{'ForeName': 'Yoon-Hee', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': 'a Department of Physical Therapy , Graduate School of Daejeon University , Daejeon City , Republic of Korea.'}, {'ForeName': 'Jung-Doo', 'Initials': 'JD', 'LastName': 'Kim', 'Affiliation': 'b Rehabilitation Center, Bonifacio Hospital , Daejeon City , Republic of Korea.'}, {'ForeName': 'Jun-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'c Department of Emergency Medical Technology , College of Health and Medical Science, Daejeon University , Daejeon City, Republic of Korea.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'd Department of Physical Therapy , College of Health and Medical Science, Daejeon University , Daejeon City, Republic of Korea.'}]",Assistive technology : the official journal of RESNA,['10.1080/10400435.2017.1387616']
1729,30682452,A sputum 6-gene signature predicts future exacerbations of poorly controlled asthma.,"BACKGROUND


Improved diagnostic tools for predicting future exacerbation frequency in asthmatic patients are required. A sputum gene expression signature of 6 biomarkers (6-gene signature [6GS], including Charcot-Leyden crystal galectin [CLC]; carboxypeptidase 3 [CPA3]; deoxyribonuclease 1-like 3 [DNASE1L3]; alkaline phosphatase, liver/bone/kidney [ALPL]; CXCR2; and IL1B) predicts inflammatory and treatment response phenotypes in patients with stable asthma. Recently, we demonstrated that azithromycin (AZM) add-on treatment in patients with uncontrolled moderate-to-severe asthma significantly reduced asthma exacerbations (AMAZES clinical trial).
OBJECTIVES


We sought to test whether the 6GS predicts future exacerbation and inflammatory phenotypes in a subpopulation of AMAZES and to test the effect of AZM therapy on 6GS expression and prognostic capacity.
METHODS


One hundred forty-two patients (73 placebo-treated and 69 AZM-treated patients) had sputum stored for quantitative PCR of 6GS markers at baseline and after 48 weeks of treatment. Logistic regression and receiver operating characteristic and area under the curve (AUC) determination were performed on baseline measures, and in an exploratory analysis the predictive value of the 6GS was compared with conventional biomarkers for exacerbation and inflammatory phenotypes.
RESULTS


The 6GS significantly predicted all future exacerbation phenotypes tested. Calculated AUCs for the 6GS were significantly greater than AUCs for peripheral blood eosinophil counts, sputum neutrophil counts, and combined sputum eosinophil and neutrophil counts. 6GS AUCs were also numerically but not significantly greater than those for fractional exhaled nitric oxide values and sputum eosinophil counts. AZM treatment altered neither 6GS expression nor the predictive capacity of the 6GS for future exacerbation phenotypes. The 6GS was a significant predictor of airway inflammatory phenotype in this population.
CONCLUSION


We demonstrate that a sputum gene signature can predict future exacerbation phenotypes of asthma, with the greatest biomarker performance in identifying those who would experience frequent severe exacerbations. AZM therapy did not modify 6GS expression or biomarker performance, suggesting the therapeutic action of AZM is independent of 6GS-related inflammatory pathways.",2019,"Calculated AUCs for the 6GS were significantly greater than AUCs for peripheral blood eosinophil counts, sputum neutrophil counts, and combined sputum eosinophil and neutrophil counts.","['patients with uncontrolled moderate-to-severe asthma significantly reduced asthma exacerbations (AMAZES clinical trial', 'patients with stable asthma', 'asthmatic patients', 'One hundred forty-two patients (73 placebo-treated and 69 AZM-treated patients) had sputum stored for quantitative PCR of 6GS markers at baseline and after 48\xa0weeks of treatment']","['AZM therapy', 'AZM', 'azithromycin (AZM', 'Charcot-Leyden crystal galectin [CLC', '6GS']","['Logistic regression and receiver operating characteristic and area under the curve (AUC) determination', '6GS expression or biomarker performance', 'fractional exhaled nitric oxide values and sputum eosinophil counts', 'peripheral blood eosinophil counts, sputum neutrophil counts, and combined sputum eosinophil and neutrophil counts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0102901', 'cui_str': 'Amaze'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0863141', 'cui_str': 'Charcot-Leyden crystals'}, {'cui': 'C0607430', 'cui_str': 'Lectins, S-Type'}]","[{'cui': 'C0206031', 'cui_str': 'Logistic Regression'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count - observation'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}]",142.0,0.109068,"Calculated AUCs for the 6GS were significantly greater than AUCs for peripheral blood eosinophil counts, sputum neutrophil counts, and combined sputum eosinophil and neutrophil counts.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fricker', 'Affiliation': 'Priority Research Centre for Healthy Lungs, University of Newcastle, Newcastle, Australia. Electronic address: michael.fricker@newcastle.edu.au.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Gibson', 'Affiliation': 'Priority Research Centre for Healthy Lungs, University of Newcastle, Newcastle, Australia; Department of Respiratory and Sleep Medicine, John Hunter Hospital, Newcastle, Australia; Woolcock Institute of Medical Research, Sydney, Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Powell', 'Affiliation': 'Priority Research Centre for Healthy Lungs, University of Newcastle, Newcastle, Australia; Department of Respiratory and Sleep Medicine, John Hunter Hospital, Newcastle, Australia.'}, {'ForeName': 'Jodie L', 'Initials': 'JL', 'LastName': 'Simpson', 'Affiliation': 'Priority Research Centre for Healthy Lungs, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Yang', 'Affiliation': 'Diamantina Institute, University of Queensland, Brisbane, Australia; Department of Thoracic Medicine, Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Upham', 'Affiliation': 'Diamantina Institute, University of Queensland, Brisbane, Australia; Department of Respiratory Medicine, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Reynolds', 'Affiliation': 'Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, Australia; Lung Research Laboratory, Hanson Institute, Adelaide, Australia; School of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Hodge', 'Affiliation': 'Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, Australia; Lung Research Laboratory, Hanson Institute, Adelaide, Australia; School of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'James', 'Affiliation': 'Department of Pulmonary Physiology and Sleep Medicine, Sir Charles Gairdner Hospital, Perth, Australia; School of Medicine and Pharmacology, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Jenkins', 'Affiliation': 'Respiratory Trials, George Institute for Global Health, Sydney, Australia; Department of Thoracic Medicine, Concord General Hospital, Sydney, Australia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Peters', 'Affiliation': 'Department of Thoracic Medicine, Concord General Hospital, Sydney, Australia; Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Guy B', 'Initials': 'GB', 'LastName': 'Marks', 'Affiliation': 'Woolcock Institute of Medical Research, Sydney, Australia; South Western Sydney Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Baraket', 'Affiliation': 'Respiratory Medicine Department and Ingham Institute Liverpool Hospital, University of New South Wales, Medicine Faculty, Sydney, Australia.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Baines', 'Affiliation': 'Priority Research Centre for Healthy Lungs, University of Newcastle, Newcastle, Australia.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2018.12.1020']
1730,30765235,Comparison of conventional and laser-aided fiberotomy in relapse tendency of rotated tooth: A randomized controlled clinical trial.,"INTRODUCTION


The aim of the present study was to compare the tendency of mandibular incisor rotation relapse after conventional circumferential supracrestal fiberotomy (CSF) with Er,Cr:YSGG laser-aided CSF.
METHODS


In this three-arm parallel study, the patients with one lower incisor rotation greater than 30 degrees before treatment were selected. The patients were randomly assigned to three groups in a 1:1:1 ratio. Rotational relapse tendency was measured on a digitized model one month after arch wire removal. Probing depth, clinical crown height and pain levels were also measured.
RESULTS


A total of 46 patients were recruited. Relapse tendency in conventional CSF and laser-aided CSF groups were 5.09±1.59° and 4.87±2.08°, respectively, and significantly lower than 11.28±2.93° in the control group (P<0.001). Relapse tendency was not different between the conventional CSF and laser CSF groups. Probing depth, clinical crown height, and experienced pain levels exhibited negligible differences.
CONCLUSIONS


Er,Cr:YSGG laser-aided CSF in one month was as effective in reducing rotational relapse tendency of mandibular incisor teeth as conventional CSF.",2019,YSGG laser-aided CSF in one month was as effective in reducing rotational relapse tendency of mandibular incisor teeth as conventional CSF.,"['patients with one lower incisor rotation greater than 30 degrees before treatment were selected', 'relapse tendency of rotated tooth', 'A total of 46 patients were recruited']","['Er,Cr', 'conventional and laser-aided fiberotomy', 'conventional CSF and laser-aided CSF', 'conventional circumferential supracrestal fiberotomy (CSF) with Er,Cr:YSGG laser-aided CSF', 'YSGG laser-aided CSF']","['Probing depth, clinical crown height, and experienced pain levels', 'Probing depth, clinical crown height and pain levels', 'Rotational relapse tendency', 'Relapse tendency', 'mandibular incisor rotation relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0266071', 'cui_str': 'Rotation of tooth (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}]","[{'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",46.0,0.0238815,YSGG laser-aided CSF in one month was as effective in reducing rotational relapse tendency of mandibular incisor teeth as conventional CSF.,"[{'ForeName': 'Amir Farhang', 'Initials': 'AF', 'LastName': 'Miresmæili', 'Affiliation': 'Department of Orthodontics, Dental Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mollabashi', 'Affiliation': 'Department of Orthodontics, Dental Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Gholami', 'Affiliation': 'Department of Periodontics, School of Dentistry, Hamadan University of Medical Sciences, Hamadan, Iran; Department of Periodontics, Dentofacial Deformities Research Center, Dental Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Farhadian', 'Affiliation': 'Department of Biostatistics, School of Public Health and Research Center for Health Sciences, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Loghman', 'Initials': 'L', 'LastName': 'Rezaei-Soufi', 'Affiliation': 'Restorative Department, Dental Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Javanshir', 'Affiliation': 'Department of Orthodontics, Anzali International Campus, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Malekshoar', 'Affiliation': 'Department of Orthodontics, Dental Research Center, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: miladmalekshoar@rocketmail.com.'}]",International orthodontics,['10.1016/j.ortho.2019.01.018']
1731,30134294,Costs of streamlined HIV care delivery in rural Ugandan and Kenyan clinics in the SEARCH Studys.,"OBJECTIVES/DESIGN


As antiretroviral therapy (ART) rapidly expands in sub-Saharan Africa using new efficient care models, data on costs of these approaches are lacking. We examined costs of a streamlined HIV care delivery model within a large HIV test-and-treat study in Uganda and Kenya.
METHODS


We calculated observed per-person-per-year (ppy) costs of streamlined care in 17 health facilities in SEARCH Study intervention communities (NCT: 01864603) via micro-costing techniques, time-and-motion studies, staff interviews, and administrative records. Cost categories included salaries, ART, viral load testing, recurring goods/services, and fixed capital/facility costs. We then modeled costs under three increasingly efficient scale-up scenarios: lowest-cost ART, centralized viral load testing, and governmental healthcare worker salaries. We assessed the relationship between community-specific ART delivery costs, retention in care, and viral suppression.
RESULTS


Estimated streamlined HIV care delivery costs were $291/ppy. ART ($117/ppy for TDF/3TC/EFV [40%]) and viral load testing ($110/ppy for 2 tests/year [39%]) dominated costs versus salaries ($51/ppy), recurring costs ($5/ppy), and fixed costs ($7/ppy). Optimized ART scale-up with lowest-cost ART ($100/ppy), annual viral load testing ($24/ppy), and governmental healthcare salaries ($27/ppy), lowered streamlined care cost to $163/ppy. We found clinic-to-clinic heterogeneity in retention and viral suppression levels versus streamlined care delivery costs, but no correlation between cost and either retention or viral suppression.
CONCLUSIONS


In the SEARCH Study, streamlined HIV care delivery costs were similar to or lower than prior estimates despite including viral load testing; further optimizations could substantially reduce costs further. These data can inform global strategies for financing ART expansion to achieve UNAIDS 90-90-90 targets.",2018,"We found clinic-to-clinic heterogeneity in retention and viral suppression levels versus streamlined care delivery costs, but no correlation between cost and either retention or viral suppression.
","['rural Ugandan and Kenyan clinics', 'We calculated observed per-person-per-year (ppy) costs of streamlined care in 17 health facilities in SEARCH Study intervention communities (NCT: 01864603) via micro-costing techniques, time-and-motion studies, staff interviews, and administrative records', 'Uganda and Kenya']",[],"['salaries, ART, viral load testing, recurring goods/services, and fixed capital/facility costs', 'Estimated streamlined HIV care delivery costs', 'costs versus salaries ($51/ppy), recurring costs ($5/ppy), and fixed costs']","[{'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C1704764', 'cui_str': 'Per'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0040224', 'cui_str': 'Time and Motion Studies'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1301664', 'cui_str': 'Administrative record'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}]",[],"[{'cui': 'C0036064', 'cui_str': 'Wages'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",90.0,0.0469382,"We found clinic-to-clinic heterogeneity in retention and viral suppression levels versus streamlined care delivery costs, but no correlation between cost and either retention or viral suppression.
","[{'ForeName': 'Starley B', 'Initials': 'SB', 'LastName': 'Shade', 'Affiliation': 'Institute for Global Health Sciences.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Osmand', 'Affiliation': 'Division of Prevention Science, University of California, San Francisco, California, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Luo', 'Affiliation': 'Institute for Global Health Sciences.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Aine', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Assurah', 'Affiliation': 'Kenya Medical Research Institute.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Mwebaza', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mwai', 'Affiliation': 'University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Asiphas', 'Initials': 'A', 'LastName': 'Owaraganise', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Mwangwa', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ayieko', 'Affiliation': 'Kenya Medical Research Institute.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Black', 'Affiliation': 'Division of HIV, Infectious Diseases & Global Medicine, University of California, San Francisco, California.'}, {'ForeName': 'Lillian B', 'Initials': 'LB', 'LastName': 'Brown', 'Affiliation': 'Division of HIV, Infectious Diseases & Global Medicine, University of California, San Francisco, California.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'Division of HIV, Infectious Diseases & Global Medicine, University of California, San Francisco, California.'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Department of Medical and Health Policy, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'Bixby Center for Reproductive Health, University of California, San Francisco, California.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Kenya Medical Research Institute.'}, {'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Charlebois', 'Affiliation': 'Division of Prevention Science, University of California, San Francisco, California, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Balzer', 'Affiliation': 'School of Public Health & Health Sciences, University of Massachusetts, Amherst, Massachusetts, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Maya L', 'Initials': 'ML', 'LastName': 'Petersen', 'Affiliation': 'Berkeley School of Public Health, Berkeley, California, USA.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'Division of HIV, Infectious Diseases & Global Medicine, University of California, San Francisco, California.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Division of HIV, Infectious Diseases & Global Medicine, University of California, San Francisco, California.'}]","AIDS (London, England)",['10.1097/QAD.0000000000001958']
1732,30745307,Dexamethasone implant for non-infectious uveitis: is it cost-effective?,"BACKGROUND


Uveitis is inflammation inside the eye. The objective of this study is to assess the cost-effectiveness of a dexamethasone implant plus current practice (immunosuppressants and systemic corticosteroids) compared with current practice alone, in patients with non-infectious intermediate, posterior or pan-uveitis and to identify areas for future research.
METHODS


A Markov model was built to estimate the costs and benefits of dexamethasone. Systematic reviews were performed to identify available relevant evidence. Quality of life data from the key randomised-controlled trial (HURON) was used to estimate the interventions' effectiveness compared with the trial's comparator arm (placebo plus limited current practice (LCP)). The analysis took a National Health Service and Personal Social Services perspective. Costs were calculated based on standard UK sources.
RESULTS


The incremental cost-effectiveness ratio (ICER) of one dexamethasone implant compared with LCP is estimated as £19 509 per quality-adjusted life year (QALY) gained. The factors with the largest impact on the results were rate of blindness and relative proportion of blindness cases avoided by dexamethasone. Using plausible alternative assumptions, dexamethasone could be cost saving or it may be associated with an ICER of £56 329 per QALY gained compared with LCP.
CONCLUSIONS


Dexamethasone is estimated to be cost-effective using generally accepted UK thresholds. However, there is substantial uncertainty around these results due to scarcity of evidence. Future research on the following would help provide more reliable estimates: effectiveness of dexamethasone versus current practice (instead of LCP), with subgroup analyses for unilateral and bilateral uveitis, incidence of long-term blindness and effectiveness of dexamethasone in avoiding blindness.",2019,"Using plausible alternative assumptions, dexamethasone could be cost saving or it may be associated with an ICER of £56 329 per QALY gained compared with LCP.
","['patients with non-infectious intermediate, posterior or pan-uveitis and to identify areas for future research', 'non-infectious uveitis']","['Dexamethasone', 'Dexamethasone implant', 'dexamethasone implant plus current practice (immunosuppressants and systemic corticosteroids', 'dexamethasone', 'dexamethasone implant']","['incremental cost-effectiveness ratio (ICER', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0035168'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressants'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.123351,"Using plausible alternative assumptions, dexamethasone could be cost saving or it may be associated with an ICER of £56 329 per QALY gained compared with LCP.
","[{'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Squires', 'Affiliation': 'Health Economics and Decision Sciences (HEDS), School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK h.squires@sheffield.ac.uk.'}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Bermejo', 'Affiliation': 'Health Economics and Decision Sciences (HEDS), School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Edith N', 'Initials': 'EN', 'LastName': 'Poku', 'Affiliation': 'Health Economics and Decision Sciences (HEDS), School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Health Economics and Decision Sciences (HEDS), School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': 'Health Economics and Decision Sciences (HEDS), School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hamilton', 'Affiliation': 'Health Economics and Decision Sciences (HEDS), School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wong', 'Affiliation': 'Health Economics and Decision Sciences (HEDS), School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Alastair K', 'Initials': 'AK', 'LastName': 'Denniston', 'Affiliation': 'Institute of Inflammation and Ageing, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Pearce', 'Affiliation': ""Clinical Eye Research Centre, St Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, UK.""}, {'ForeName': 'Fahd Mohammed', 'Initials': 'FM', 'LastName': 'Quhill', 'Affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-312765']
1733,30690293,The impact of chemotherapy on survival of patients with extremity and trunk wall soft tissue sarcoma: revisiting the results of the EORTC-STBSG 62931 randomised trial.,"BACKGROUND


This study was aimed at determining whether patients with high-risk soft tissue sarcoma (STS), as identified using the nomogram Sarculator, benefitted from adjuvant chemotherapy in the EORTC-STBSG 62931 randomised controlled trial (RCT), which failed to detect an impact for adjuvant doxorubicin plus ifosfamide (Adj) over observation (Obs).
METHODS


Patients with extremity and trunk wall STS in the EORTC-STBSG 62931 RCT were analysed (N = 290/351). Ten-year predicted probability of overall survival (pr-OS) was calculated using the prognostic nomogram Sarculator. Patients were grouped into three categories of predicted pr-OS: high (pr-OS>66%), intermediate (51<pr-OS≤66) and low (pr-OS≤51%). OS and disease-free survival (DFS) were calculated.
RESULTS


Nomogram pr-OS was dispersed (median 72%, interquartile range 57-83%) and had prognostic value for OS and DFS (log-rank test: P < 0.001). One hundred seventy, 68 and 52 patients had high (58.6%, 90 Obs/80 Adj), intermediate (23.5%, 34 Obs/34 Adj) and low pr-OS (17.9%, 24 Obs/28 Adj), respectively. Adjuvant chemotherapy halved the risk of recurrence (hazard ratio [HR] = 0.46, 95% confidence interval [CI] 0.24-0.89) and death (HR = 0.46, 95% CI 0.23-0.94) in the low pr-OS category, while no effect was detected in intermediate and high pr-OS categories. To strengthen these findings, study participants with pr-OS<60% were combined (N = 80, 27.6%, 39 Obs/41 Adj), and a significant DFS (HR = 0.49, 95% CI 0.28-0.85) and OS (HR = 0.50, 95% CI 0.30-0.90) benefit was detected.
CONCLUSION


Patients of the EORTC-STBSG 62931 RCT with extremity and trunk wall STS and a low predicted pr-OS (high-risk patients) had better outcomes when treated with adjuvant chemotherapy. This may help reconcile the disparate results of clinical studies on adjuvant/neoadjuvant chemotherapy in STS.",2019,"Adjuvant chemotherapy halved the risk of recurrence (hazard ratio [HR] = 0.46, 95% confidence interval [CI] 0.24-0.89) and death (HR = 0.46, 95% CI 0.23-0.94) in the low pr-OS category, while no effect was detected in intermediate and high pr-OS categories.","['Patients with extremity and trunk wall STS in the EORTC-STBSG 62931 RCT were analysed (N\xa0=\xa0290/351', 'patients with extremity and trunk wall soft tissue sarcoma', 'patients with high-risk soft tissue sarcoma (STS']","['adjuvant chemotherapy', 'doxorubicin plus ifosfamide (Adj) over observation (Obs', 'Adjuvant chemotherapy', 'chemotherapy']","['probability of overall survival (pr-OS', 'prognostic value for OS and DFS', 'death', 'OS and disease-free survival (DFS', 'risk of recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",62931.0,0.185525,"Adjuvant chemotherapy halved the risk of recurrence (hazard ratio [HR] = 0.46, 95% confidence interval [CI] 0.24-0.89) and death (HR = 0.46, 95% CI 0.23-0.94) in the low pr-OS category, while no effect was detected in intermediate and high pr-OS categories.","[{'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Pasquali', 'Affiliation': 'Sarcoma Service, Department of Surgery, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy. Electronic address: sandro.pasquali@istitutotumori.mi.it.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Pizzamiglio', 'Affiliation': 'Unit of Bioinformatics and Biostatistics, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Touati', 'Affiliation': 'European Organisation for Research and Treatment of Cancer (EORTC), Belgium.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Litiere', 'Affiliation': 'European Organisation for Research and Treatment of Cancer (EORTC), Belgium.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'European Organisation for Research and Treatment of Cancer (EORTC), Belgium.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Kasper', 'Affiliation': 'University of Heidelberg, Mannheim University Medical Center, Interdisciplinary Tumor Center, Sarcoma Unit, Mannheim, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Clinical Oncology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Stacchiotti', 'Affiliation': 'Medical Oncology Unit 2, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Judson', 'Affiliation': 'The Institute of Cancer Research, Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Angelo P', 'Initials': 'AP', 'LastName': 'Dei Tos', 'Affiliation': 'Treviso General Hospital, Treviso, Italy; Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Verderio', 'Affiliation': 'Unit of Bioinformatics and Biostatistics, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'Paolo G', 'Initials': 'PG', 'LastName': 'Casali', 'Affiliation': 'Medical Oncology Unit 2, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy; The Institute of Cancer Research, Royal Marsden NHS Foundation Trust, London, United Kingdom; Treviso General Hospital, Treviso, Italy; Department of Medicine, University of Padova, Padova, Italy; Oncology and Haemato-Oncology Department, University of Milan, Italy.'}, {'ForeName': 'Penella J', 'Initials': 'PJ', 'LastName': 'Woll', 'Affiliation': 'Academic Unit of Clinical Oncology, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gronchi', 'Affiliation': 'Sarcoma Service, Department of Surgery, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy. Electronic address: alesssandro.gronchi@istitutotumori.mi.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2018.12.009']
1734,30690294,Five-year outcomes from a phase 3 METRIC study in patients with BRAF V600 E/K-mutant advanced or metastatic melanoma.,"BACKGROUND


Primary findings from the METRIC (TMT212A2301) study demonstrated that trametinib improved progression-free survival (PFS) and overall survival (OS) compared with chemotherapy in patients with unresectable or metastatic cutaneous melanoma with a BRAF V600 E/K mutation. However, clinical data characterising the long-term use of these therapies in combination with BRAF inhibitors or as monotherapies are limited.
METHODS


In this open-label, phase 3 study, 322 patients with BRAF V600 E/K-mutant metastatic melanoma were randomised in a 2:1 ratio to receive trametinib (2 mg orally, once daily; n = 214) or chemotherapy (dacarbazine [1000 mg/m 2 ] or paclitaxel [175 mg/m 2 ] intravenously, every 3 weeks; n = 108). Patients who progressed on chemotherapy were allowed to cross over and receive trametinib. Five-year results of efficacy and safety analyses are reported.
RESULTS


The median PFS was 4.9 months in the trametinib arm versus 1.5 months in the chemotherapy arm (hazard ratio, 0.54; 95% confidence interval, 0.41-0.73). Landmark OS rates for trametinib versus chemotherapy arms at 1 year, 2 years and 5 years were 60.9% versus 49.6%, 32.0% versus 29.4% and 13.3% versus 17.0%, respectively. Most patients (n = 70 [65%]) from the chemotherapy arm crossed over to the trametinib arm early in their treatment. No unexpected adverse events were reported.
CONCLUSIONS


This 5-year follow-up of patients with BRAF V600 E/K-mutant metastatic melanoma on a targeted therapy demonstrates that long-term use of trametinib is possible with no new or unexpected adverse events. Some patients experienced long-term survival benefit with trametinib monotherapy (METRIC ClinicalTrials.gov number, NCT01245062.).",2019,"Landmark OS rates for trametinib versus chemotherapy arms at 1 year, 2 years and 5 years were 60.9% versus 49.6%, 32.0% versus 29.4% and 13.3% versus 17.0%, respectively.","['patients with BRAF V600\xa0E/K-mutant advanced or metastatic melanoma', '322 patients with BRAF V600\xa0E/K-mutant metastatic melanoma', 'patients with unresectable or metastatic cutaneous melanoma with a BRAF V600\xa0E/K mutation']","['BRAF inhibitors', 'chemotherapy', 'trametinib (2\xa0mg orally, once daily; n\xa0=\xa0214) or chemotherapy (dacarbazine [1000\xa0mg/m 2 ] or paclitaxel']","['Landmark OS rates', 'median PFS', 'progression-free survival (PFS) and overall survival (OS', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",322.0,0.365758,"Landmark OS rates for trametinib versus chemotherapy arms at 1 year, 2 years and 5 years were 60.9% versus 49.6%, 32.0% versus 29.4% and 13.3% versus 17.0%, respectively.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Department of Dermatology, Institut Gustave Roussy, Villejuif, France. Electronic address: Caroline.ROBERT@gustaveroussy.fr.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nathan', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hersey', 'Affiliation': 'University of Sydney, Sydney, Australia.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'University Medical Center, Tübingen, Germany.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Milhem', 'Affiliation': 'University of Iowa Hospital and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Lev', 'Initials': 'L', 'LastName': 'Demidov', 'Affiliation': 'N. N. Blokhin Russian Cancer Research Center, Ministry of Health, Moscow, Russian Federation.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mohr', 'Affiliation': 'Elbe Klinikum Buxtehude, Buxtehude, Germany.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Hassel', 'Affiliation': 'University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie Institute Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Utikal', 'Affiliation': 'German Cancer Research Center (DKFZ) and University Medical Center Mannheim, Ruprecht-Karl University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kiecker', 'Affiliation': 'Charité-Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': ""D'Amelio"", 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Bijoyesh', 'Initials': 'B', 'LastName': 'Mookerjee', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2018.12.015']
1735,30732967,[Non-randomized trial to evaluate a continuous physiotherapy program versus interval in overweight patients suffering from acute coronary syndrome].,"We present a non-randomised trial to evaluate a continuous physiotherapy program versus a periodic one in overweight patients suffering from acute coronary syndrome.
AIM


To detect differences between a continuous (CONT) physiotherapy program (PF) and a periodic (INT) physiotherapy program in overweight patients with acute coronary syndrome on anthropometric parameters, analytical parameters, heart rate, adherence, drop-outs, safety and tolerance.
DESIGN


A multicentre, non-randomised two-armed quasi-experimental study with pre-post design.
LOCATION


Community cardiac prevention centres (Manises, Valencia-LaFe, Játiva-Onteniente Health Department).
PARTICIPANTS


The study included a total of 339 overweight participants with acute coronary syndrome; living in the community; aged more than 18; no contraindication for physical exercise; no previous participation in a PF.
INTERVENTIONS


Participants were assigned to a CONT training or an INT training (2 months). Each session was divided in warm-up, endurance, and cool-down. Endurance was performed at 12-13 Borg intensity and with heat rate calculated, with maximum heat rate obtained in the baseline ergometry.
MAIN MEASUREMENTS


Body mass index, waist circumference, lipid profile, blood glucose, glycosylated haemoglobin, resting heat rate, adherence, drop-outs, safety, and tolerance were assessed.
RESULTS


The CONT group showed significantly better differences in body mass index, waist circumference, total cholesterol, triglycerides, blood glucose, glycosylated haemoglobin and resting heat rate. No differences were observed in adherence, drop-outs, safety, and tolerance.
CONCLUSIONS


The CONT group obtained better results in all variables except for HDL cholesterol. Both programs offered a high adherence, safety, and tolerance.",2020,"The CONT group showed significantly better differences in body mass index, waist circumference, total cholesterol, triglycerides, blood glucose, glycosylated haemoglobin and resting heat rate.","['overweight patients suffering from acute coronary syndrome', 'overweight patients with acute coronary syndrome', '339 overweight participants with acute coronary syndrome; living in the community; aged more than 18; no contraindication for physical exercise; no previous participation in a PF']","['continuous physiotherapy program', 'continuous (CONT) physiotherapy program (PF) and a periodic (INT) physiotherapy program', 'CONT training or an INT training']","['HDL cholesterol', 'anthropometric parameters, analytical parameters, heart rate, adherence, drop-outs, safety and tolerance', 'adherence, drop-outs, safety, and tolerance', 'body mass index, waist circumference, total cholesterol, triglycerides, blood glucose, glycosylated haemoglobin and resting heat rate', 'Body mass index, waist circumference, lipid profile, blood glucose, glycosylated haemoglobin, resting heat rate, adherence, drop-outs, safety, and tolerance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332182', 'cui_str': 'Periodic (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",339.0,0.0279091,"The CONT group showed significantly better differences in body mass index, waist circumference, total cholesterol, triglycerides, blood glucose, glycosylated haemoglobin and resting heat rate.","[{'ForeName': 'Miryam', 'Initials': 'M', 'LastName': 'Olivares Jara', 'Affiliation': 'Departamento de Salud Manises, Servicio de Cardiología, Hospital de Manises, Valencia, España.'}, {'ForeName': 'Maria Isabel', 'Initials': 'MI', 'LastName': 'Vázquez Arce', 'Affiliation': 'Departamento de Salud La Fe, Servicio de Rehabilitación y Medicina Física, Hospital Universitario y Politécnico La Fe, Valencia, España; Universidad San Vicente Mártir, Valencia, España.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Peña Pachés', 'Affiliation': 'Departamento de Salud Manises, Servicio de Rehabilitación, Hospital de Manises, Valencia, España.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Roser Mas', 'Affiliation': 'Departamento de Salud Manises, Servicio de Rehabilitación, Hospital de Manises, Valencia, España.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Pérez-Alenda', 'Affiliation': 'Departamento de Fisioterapia, Universidad de Valencia, Valencia, España.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Marques-Sule', 'Affiliation': 'Departamento de Fisioterapia, Universidad de Valencia, Valencia, España; Departamentos de Salud Valencia, Instituto Valenciano del Corazón, Játiva, Onteniente, Valencia, España. Electronic address: elena.marques@uv.es.'}]",Atencion primaria,['10.1016/j.aprim.2018.09.015']
1736,30719774,Autologous platelet-rich plasma covering urethroplasty versus dartos flap in distal hypospadias repair: A prospective randomized study.,"OBJECTIVE


To compare the outcome and complication rate of the platelet-rich plasma applied as a coverage layer and dartos flap layer during primary repair of distal hypospadias.
METHODS


A prospective randomized study was carried out comprising 180 boys (age range 12-65 months) from October 2011 to December 2016 at Al-Azhar University Hospitals, Cairo, Egypt. A single surgeon carried out all urethroplasty. Patients were randomly divided into two groups: group A (tubularized incised plate urethroplasty with platelet-rich plasma coverage layer) and group B (ventral dartos flap). Complication rates were compared between two groups.
RESULTS


There was a significant difference in the occurrence of complications between the two groups. A total of 36 (20%) complications were recorded in 26 patients, just 12 (13.3%) reported in group A, but 24 (26.7%) complications were reported in group B. Urethrocutaneous fistula was observed in nine patients (10%) in group A, and 12 (13.3%) in group B. Partial glans dehiscence occurred in one patient in group A, and four patients in group B. No patient in group A had a superficial wound infection, compared with six patients in group B. One case of meatal stenosis and urethral stricture was recorded in each group, all of which were managed conservatively. The resultant urinary stream was single and good in 154 patients of both groups.
CONCLUSIONS


Platelet-rich plasma sheet might be considered as an alternative coverage layer for distal hypospadias repair, especially in the absence of a healthy layer.",2019,"One case of meatal stenosis and urethral stricture was recorded in each group, all of which were managed conservatively.","['180 boys (age range 12-65\xa0months) from October 2011 to December 2016 at Al-Azhar University Hospitals, Cairo, Egypt', '154 patients of both groups', 'distal hypospadias repair']","['group\xa0A (tubularized incised plate urethroplasty with platelet-rich plasma coverage layer) and group\xa0B (ventral dartos flap', 'Autologous platelet-rich plasma covering urethroplasty versus dartos flap']","['Complication rates', 'B. Partial glans dehiscence', 'occurrence of complications', 'superficial wound infection', 'Urethrocutaneous fistula', 'meatal stenosis and urethral stricture']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra (procedure)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0440926', 'cui_str': 'Dartos flap (substance)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0332804', 'cui_str': 'Superficial wound (morphologic abnormality)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0431750', 'cui_str': 'Stenosis of urinary meatus (disorder)'}, {'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}]",180.0,0.0178328,"One case of meatal stenosis and urethral stricture was recorded in each group, all of which were managed conservatively.","[{'ForeName': 'Abdelaziz Yehya', 'Initials': 'AY', 'LastName': 'Mahmoud', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gouda', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Gamaan', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Baky Fahmy', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.13912']
1737,30711602,Impact of time pressure on dentists' diagnostic performance.,"OBJECTIVES


Although stress is prevalent amongst dentists, there is a paucity of data on the impact of stressors on dentists' clinical performance. To address this gap in the literature, the aim of the present study was to explore the role of time pressure, representing one common stressor, on dentists' radiographic diagnostic performance.
METHODS


Forty dentists were randomised to examine and provide a radiographic report on two sets of radiographs (six bitewings in each set) under two conditions on a cross-over basis: time-pressure vs. no-time-pressure. The radiographic report of an experienced consultant was considered the gold standard against which participants diagnostic decisions were compared to calculate sensitivity and specificity. Participants rated their stress after each experimental condition using a 100 mm visual analogue scale (VAS).
RESULTS


The VAS scores for stress were significantly higher in the time pressure condition vs. no time pressure condition (mean: 55.78 versus 10.73, p < 0.0001), indicating that the time pressure acted as a source of stress. Dentists' diagnostic performance was affected; the sensitivity was significantly lower under time pressure (median: 0.50 versus 0.80, p < 0.0001), but by contrast, the median diagnostic specificity was 1.00 under both conditions.
CONCLUSIONS


Time pressure negatively impacts one aspect of dentists' diagnostic performance, namely sensitivity (increased diagnostic errors and omissions of pathology), which can potentially affect patient safety and the quality of care delivered. However, time pressure was found to have less influence on diagnostic specificity.
CLINICAL SIGNIFICANCE


The present study demonstrated a significant deterioration of dentists' diagnostic performance (sensitivity) under time-pressure when examining bitewing radiographs. Diagnostic errors may put patient safety at risk, with patients potentially being harmed if pathology is missed. Such errors can have medicolegal implications on the dentists' practice.",2019,"Dentists' diagnostic performance was affected; the sensitivity was significantly lower under time pressure (median: 0.50 versus 0.80, p < 0.0001), but by contrast, the median diagnostic specificity was 1.00 under both conditions.
","[""dentists' diagnostic performance"", 'Forty dentists']",['radiographs (six bitewings in each set) under two conditions on a cross-over basis: time-pressure vs. no-time-pressure'],"['diagnostic specificity', 'median diagnostic specificity', 'VAS scores for stress', ""dentists' diagnostic performance (sensitivity) under time-pressure"", 'visual analogue scale (VAS']","[{'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",40.0,0.0465043,"Dentists' diagnostic performance was affected; the sensitivity was significantly lower under time pressure (median: 0.50 versus 0.80, p < 0.0001), but by contrast, the median diagnostic specificity was 1.00 under both conditions.
","[{'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Plessas', 'Affiliation': 'Peninsula Dental School, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, PL6 8BT, England, UK. Electronic address: anastasios.plessas@plymouth.ac.uk.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Nasser', 'Affiliation': 'Peninsula Dental School, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, PL6 8BT, England, UK. Electronic address: mona.nasser@plymouth.ac.uk.'}, {'ForeName': 'Yaniv', 'Initials': 'Y', 'LastName': 'Hanoch', 'Affiliation': 'School of Psychology, Faculty of Health and Human Sciences, University of Plymouth, Plymouth, PL4 8AA, England, UK. Electronic address: yaniv.hanoch@plymouth.ac.uk.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': ""O'Brien"", 'Affiliation': 'Peninsula Dental School, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, PL6 8BT, England, UK. Electronic address: timothy.obrien@plymouth.ac.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bernardes Delgado', 'Affiliation': 'Peninsula Dental School, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, PL6 8BT, England, UK. Electronic address: mariadocarmo.bernardesdelgado@plymouth.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moles', 'Affiliation': 'Peninsula Dental School, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, PL6 8BT, England, UK. Electronic address: david.moles@plymouth.ac.uk.'}]",Journal of dentistry,['10.1016/j.jdent.2019.01.011']
1738,31691521,Differentiated HIV care in South Africa: the effect of fast-track treatment initiation counselling on ART initiation and viral suppression as partial results of an impact evaluation on the impact of a package of services to improve HIV treatment adherence.,"INTRODUCTION


In response to suboptimal adherence and retention, South Africa's National Department of Health developed and implemented National Adherence Guidelines for Chronic Diseases. We evaluated the effect of a package of adherence interventions beginning in January 2016 and report on the impact of Fast-Track Treatment Initiation Counselling (FTIC) on ART initiation, adherence and retention.
METHODS


We conducted a cluster-randomized mixed-methods evaluation in 4 provinces at 12 intervention sites which implemented FTIC and 12 control facilities providing standard of care. Follow-up was by passive surveillance using clinical records. We included data on subjects eligible for FTIC between 08 Jan 2016 and 07 December 2016. We adjusted for pre-intervention differences using difference-in-differences (DiD) analyses controlling for site-level clustering.
RESULTS


We enrolled 362 intervention and 368 control arm patients. Thirty-day ART initiation was 83% in the intervention and 82% in the control arm (RD 0.5%; 95% CI: -5.0% to 6.0%). After adjusting for baseline ART initiation differences and covariates using DiD we found a 6% increase in ART initiation associated with FTIC (RD 6.3%; 95% CI: -0.6% to 13.3%). We found a small decrease in viral suppression within 18 months (RD -2.8%; 95% CI: -9.8% to 4.2%) with no difference after adjustment (RD: -1.9%; 95% CI: -9.1% to 5.4%) or when considering only those with a viral load recorded (84% intervention vs. 86% control). We found reduced crude 6-month retention in intervention sites (RD -7.2%; 95% CI: -14.0% to -0.4%). However, differences attenuated by 12 months (RD: -3.6%; 95% CI: -11.1% to 3.9%). Qualitative data showed FTIC counselling was perceived as beneficial by patients and providers.
CONCLUSIONS


We saw a short-term ART-initiation benefit to FTIC (particularly in districts where initiation prior to intervention was lower), with no reductions but also no improvement in longer-term retention and viral suppression. This may be due to lack of fidelity to implementation and delivery of those components that support retention and adherence. FTIC must continue to be implemented alongside other interventions to achieve the 90-90-90 cascade and fidelity to post-initiation counselling sessions must be monitored to determine impact on longer-term outcomes. Understanding the cost-benefit and role of FTIC may then be warranted.",2019,Thirty-day ART initiation was 83% in the intervention and 82% in the control arm (RD 0.5%; 95% CI: -5.0% to 6.0%).,"['4 provinces at 12 intervention sites which implemented FTIC and 12 control facilities providing standard of care', 'Differentiated HIV care in South Africa', 'We enrolled 362 intervention and 368 control arm patients', 'subjects eligible for FTIC between 08 Jan 2016 and 07 December 2016']",['Fast-Track Treatment Initiation Counselling (FTIC'],"['viral suppression', 'ART initiation', 'longer-term retention and viral suppression', 'ART initiation, adherence and retention']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.208107,Thirty-day ART initiation was 83% in the intervention and 82% in the control arm (RD 0.5%; 95% CI: -5.0% to 6.0%).,"[{'ForeName': 'Sophie Js', 'Initials': 'SJ', 'LastName': 'Pascoe', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Fox', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Amy N', 'Initials': 'AN', 'LastName': 'Huber', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mokgadi', 'Initials': 'M', 'LastName': 'Phokojoe', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Marelize', 'Initials': 'M', 'LastName': 'Gorgens', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}, {'ForeName': 'Yogan', 'Initials': 'Y', 'LastName': 'Pillay', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Fraser-Hurt', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25409']
1739,30789856,"Ilaprazole Compared With Rabeprazole in the Treatment of Duodenal Ulcer: A Randomized, Double-blind, Active-controlled, Multicenter Study.","GOALS


The main goal of this study was to explore the dose-effect relationship of ilaprazole.
BACKGROUND


Ilaprazole is a kind of benzimidazole proton-pump inhibitor, which was confirmed efficacious and safe in treatment of duodenal ulcer (DU). However, the dose-effect relationship of ilaprazole was not clear.
STUDY


This was a double-blind, parallel, randomized study. Patients aged above 18 years with at least one endoscopically confirmed active nonmalignant DU were treated with rabeprazole 10 mg or ilaprazole 10 mg/5 mg for 4 weeks. Healing of ulcer was determined by its resolution from active to scarring stage. Symptoms relief was evaluated using a graded score. Safety and tolerability were evaluated on basis of clinical assessments.
RESULTS


A total of 390 patients completed the study finally. Ulcers were successfully healed in 75.38%, 77.86%, and 83.72% of patients after 4-week treatment with rabeprazole 10 mg, ilaprazole 5 mg, and ilaprazole 10 mg, respectively. The 4-week healing rate difference between rabeprazole 10 mg and ilaprazole 5 mg was 2.48% (95% confidence interval: -7.79% to 12.74%) leading to accept the noninferiority hypothesis. Logistic regression model suggested that ilaprazole 10 mg was superior to ilaprazole 5 mg at week 2 (odds ratio, 1.92; 95% confidence interval: 1.02, 3.59; P=0.04). Most patients (80%) became asymptomatic after treatment. At the dosages administered, the 3 drug groups exhibited similar efficacy and a similar safety profile.
CONCLUSIONS


Ilaprazole 5 mg is not inferior to rabeprazole 10 mg in treating DU, and a dose-effect relationship have been revealed between 5 mg and 10 mg of ilaprazole.",2019,The 4-week healing rate difference between rabeprazole 10 mg and ilaprazole 5 mg was 2.48% (95% confidence interval: -7.79% to 12.74%) leading to accept the noninferiority hypothesis.,"['Duodenal Ulcer', '390 patients completed the study finally', 'Patients aged above 18 years with at least one endoscopically confirmed active nonmalignant DU']","['rabeprazole', 'ilaprazole', 'Ilaprazole', 'Rabeprazole', 'rabeprazole 10\u2009mg or ilaprazole']","['Symptoms relief', 'Healing of ulcer', '4-week healing rate difference', 'Ulcers', 'Safety and tolerability']","[{'cui': 'C0013295', 'cui_str': 'Duodenal Ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C1881129', 'cui_str': 'ilaprazole'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",390.0,0.384174,The 4-week healing rate difference between rabeprazole 10 mg and ilaprazole 5 mg was 2.48% (95% confidence interval: -7.79% to 12.74%) leading to accept the noninferiority hypothesis.,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Health Statistics, Fourth Military Medical University.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Xianghong', 'Affiliation': 'Livzon Pharmaceutical Group Inc., Zhuhai, Guangdong, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Department of Health Statistics, Fourth Military Medical University.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Ying', 'Affiliation': ""Department of Gastroenterology, Fourth Military Medical University Xijing Hospital, Xi'an, Shaanxi.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Jielai', 'Affiliation': 'Department of Health Statistics, Fourth Military Medical University.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Haitang', 'Affiliation': 'Livzon Pharmaceutical Group Inc., Zhuhai, Guangdong, China.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001186']
1740,31155473,Defining Adherence to Mobile Dietary Self-Monitoring and Assessing Tracking Over Time: Tracking at Least Two Eating Occasions per Day Is Best Marker of Adherence within Two Different Mobile Health Randomized Weight Loss Interventions.,"BACKGROUND


Mobile dietary self-monitoring methods allow for objective assessment of adherence to self-monitoring; however, the best way to define self-monitoring adherence is not known.
OBJECTIVE


The objective was to identify the best criteria for defining adherence to dietary self-monitoring with mobile devices when predicting weight loss.
DESIGN


This was a secondary data analysis from two 6-month randomized trials: Dietary Intervention to Enhance Tracking with Mobile Devices (n=42 calorie tracking app or n=39 wearable Bite Counter device) and Self-Monitoring Assessment in Real Time (n=20 kcal tracking app or n=23 photo meal app).
PARTICIPANTS/SETTING


Adults (n=124; mean body mass index=34.7±5.6) participated in one of two remotely delivered weight-loss interventions at a southeastern university between 2015 and 2017.
INTERVENTION


All participants received the same behavioral weight loss information via twice-weekly podcasts. Participants were randomly assigned to a specific diet tracking method.
MAIN OUTCOME MEASURES


Seven methods of tracking adherence to self-monitoring (eg, number of days tracked, and number of eating occasions tracked) were examined, as was weight loss at 6 months.
STATISTICAL ANALYSES PERFORMED


Linear regression models estimated the strength of association (R 2 ) between each method of tracking adherence and weight loss, adjusting for age and sex.
RESULTS


Among all study completers combined (N=91), adherence defined as the overall number of days participants tracked at least two eating occasions explained the most variance in weight loss at 6 months (R 2 =0.27; P<0.001). Self-monitoring declined over time; all examined adherence methods had fewer than half the sample still tracking after Week 10.
CONCLUSIONS


Using the total number of days at least two eating occasions are tracked using a mobile self-monitoring method may be the best way to assess self-monitoring adherence during weight loss interventions. This study shows that self-monitoring rates decline quickly and elucidates potential times for early interventions to stop the reductions in self-monitoring.",2019,This study shows that self-monitoring rates decline quickly and elucidates potential times for early interventions to stop the reductions in self-monitoring.,"['Adults', 'participated in one of two remotely delivered weight-loss interventions at a southeastern university between 2015 and\xa02017', 'n=124; mean body mass index=34.7±5.6']","['Dietary Intervention to Enhance Tracking with Mobile Devices (n=42 calorie tracking app or n=39 wearable Bite Counter device) and Self-Monitoring Assessment in Real Time', 'Mobile Dietary Self-Monitoring and Assessing Tracking', 'specific diet tracking method']","[' number of days tracked, and number of eating occasions tracked', 'weight loss', 'tracking adherence to self-monitoring (eg']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0005658', 'cui_str': 'Bites'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}]",,0.0490755,This study shows that self-monitoring rates decline quickly and elucidates potential times for early interventions to stop the reductions in self-monitoring.,"[{'ForeName': 'Gabrielle M', 'Initials': 'GM', 'LastName': 'Turner-McGrievy', 'Affiliation': ''}, {'ForeName': 'Caroline Glagola', 'Initials': 'CG', 'LastName': 'Dunn', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': ''}, {'ForeName': 'Alycia K', 'Initials': 'AK', 'LastName': 'Boutté', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hutto', 'Affiliation': ''}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Hoover', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Muth', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.03.012']
1741,30707049,Flibanserin for Premenopausal Hypoactive Sexual Desire Disorder: Pooled Analysis of Clinical Trials.,"Background:  Flibanserin, a 5-hydroxytryptamine 5-HT 1A  agonist and 5-HT 2A  antagonist, is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This  post hoc  analysis assessed pooled efficacy and safety data for flibanserin in premenopausal women with HSDD.  Materials and Methods:  Data for flibanserin 100 mg once daily at bedtime (qhs) and placebo were pooled from three pivotal 24-week, randomized, placebo-controlled, multicenter studies (VIOLET, DAISY, and BEGONIA) of premenopausal women with HSDD. Pooled efficacy endpoints included the change from baseline to study end ( i.e ., 24 weeks) in the number of satisfying sexual events (SSEs) over 28 days, the Female Sexual Function Index desire domain (FSFI-d) score, and the Female Sexual Distress Scale-Revised Item 13 (FSDS-R-13) score.  Results:  The analysis included 2465 women (flibanserin,  n  = 1227; placebo,  n  = 1238) with a mean age of 36 years and a mean HSDD duration of 56.5 months. The mean ± standard error (SE) change from baseline to study end in SSEs over 28 days for flibanserin versus placebo was 2.1 ± 0.14 versus 1.2 ± 0.11, respectively ( p  < 0.0001). The least-squares mean ± SE changes from baseline to study end in FSFI desire domain score and FSDS-R-13 score were also significantly greater for flibanserin versus placebo (FSFI desire domain: 0.9 ± 0.04 vs. 0.6 ± 0.04,  p  < 0.0001; FSDS-R-13: -0.9 ± 0.04 vs. -0.6 ± 0.04,  p  < 0.0001). Patients in the flibanserin group generally had significantly greater improvements, compared with placebo, in SSEs, FSFI-d score, and FSDS-R-13 in subgroup analyses based on selected demographic and baseline clinical characteristics. Adverse events occurring in ≥10% of patients included dizziness and somnolence.  Conclusions:  This pooled analysis of three pivotal trials demonstrated that flibanserin 100 mg qhs was well tolerated, improved sexual desire, and reduced sexual distress associated with HSDD in premenopausal women, and these improvements were generally consistent across various subgroups based on demographic and baseline characteristics.",2019,"Patients in the flibanserin group generally had significantly greater improvements, compared with placebo, in SSEs, FSFI-d score, and FSDS-R-13 in subgroup analyses based on selected demographic and baseline clinical characteristics.","['premenopausal women with HSDD', 'Premenopausal Hypoactive Sexual Desire Disorder', '2465 women (flibanserin,  n \u2009=\u20091227; placebo,  n \u2009=\u20091238) with a mean age of 36 years and a mean HSDD duration of 56.5 months', 'premenopausal women']","['Flibanserin, a 5-hydroxytryptamine 5-HT 1A  agonist and 5-HT 2A  antagonist', 'placebo', 'flibanserin', 'Flibanserin']","['dizziness and somnolence', 'Adverse events', 'FSFI desire domain score and FSDS-R-13 score', 'mean\u2009±\u2009standard error (SE) change', 'SSEs, FSFI-d score, and FSDS-R-13', 'number of satisfying sexual events (SSEs) over 28 days, the Female Sexual Function Index desire domain (FSFI-d) score, and the Female Sexual Distress Scale-Revised Item 13 (FSDS-R-13) score', 'tolerated, improved sexual desire, and reduced sexual distress']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020594', 'cui_str': 'Hypoactive Sexual Desire Disorder'}, {'cui': 'C0754280', 'cui_str': 'flibanserin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0754280', 'cui_str': 'flibanserin'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0424400', 'cui_str': 'Erotic interest (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",2465.0,0.391282,"Patients in the flibanserin group generally had significantly greater improvements, compared with placebo, in SSEs, FSFI-d score, and FSDS-R-13 in subgroup analyses based on selected demographic and baseline clinical characteristics.","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': '1 Department of Obstetrics and Gynecology, George Washington University School of Medicine, Washington, District of Columbia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thorp', 'Affiliation': '2 Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Millheiser', 'Affiliation': '3 Sprout Pharmaceuticals, Inc., Raleigh, North Carolina.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7516']
1742,30793920,Low Dose Fluoroscopy During Ureteroscopy Does Not Compromise Surgical Outcomes.,"Objective:  To evaluate whether reducing the dose of fluoroscopy to ¼ of standard dose during unilateral ureteroscopy for ureteral stone treatment would impact in a reduction of total radiation emitted and whether this strategy would impact operation time, stone-free rate, and complication rate.  Methods:  From August 2016 to August 2017, patients over 18 years submitted to ureteroscopy for ureteral stone between 5 and 20 mm were prospectively randomized for ¼ dose reduction or standard dose fluoroscopy. Patients with abnormal urinary anatomy such as horseshoe kidney, pelvic kidney, or duplex system were excluded from the study.  Results:  Ninety-four patients were enrolled. The fluoroscopic dose reduction strategy to ¼ of the standard dose was able to significantly reduce the cumulative radiation emitted by C-arm fluoroscopy and the dose area product (3.6 ± 4.5 mGy  vs  16.2 ± 19.3 mGy,  p  = 0.0001 and 0.23 ± 0.52 mcGycm 2   vs  1.15 ± 2.74 mcGycm 2 ,  p  = 0.02, respectively). Fluoroscopy time was similar between groups (74.5 ± 84.8 seconds  vs  88.3 ± 90 seconds,  p  = 0.44). There was no need to increase the fluoroscopy dose during any of the procedures. Surgical outcomes were not affected by fluoroscopic dose reduction strategy.  Conclusion:  Low dose fluoroscopy reduces the emitted radiation during ureteroscopy without compromising surgical outcomes.",2019,"The fluoroscopic dose reduction strategy to ¼ of the standard dose was able to significantly reduce the cumulative radiation emitted by C-arm fluoroscopy and the dose area product (3.6±4.5 mGy vs.16.2±19.3 mGy, p=0.0001 and 0.23±0.52","['from August 2016 to August 2017', '94 patients were enrolled', 'Patients with abnormal urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system were excluded from the study', ' patients over 18 years old submitted to ureteroscopy for ureteral stone between 5-20 mm']",['standard dose fluoroscopy'],"['operation time, stone free rate and complication rate', 'Fluoroscopy time', 'cumulative radiation emitted']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0221353', 'cui_str': 'Horseshoe Kidney'}, {'cui': 'C0221209', 'cui_str': 'Congenital pelvic kidney (disorder)'}, {'cui': 'C0444916', 'cui_str': 'Duplex (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]","[{'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]",94.0,0.07633,"The fluoroscopic dose reduction strategy to ¼ of the standard dose was able to significantly reduce the cumulative radiation emitted by C-arm fluoroscopy and the dose area product (3.6±4.5 mGy vs.16.2±19.3 mGy, p=0.0001 and 0.23±0.52","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Danilovic', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Nunes', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Lipkin', 'Affiliation': '2 Division of Urologic Surgery, Surgery Department, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Ferreira', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Fabio C M', 'Initials': 'FCM', 'LastName': 'Torricelli', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Giovanni S', 'Initials': 'GS', 'LastName': 'Marchini', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Srougi', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Nahas', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Mazzucchi', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}]",Journal of endourology,['10.1089/end.2018.0722']
1743,30730251,"Transforming the attitudes of young men about gender roles and the acceptability of violence against women, Bihar.","Although the importance of working with young men to transform traditional gender norms has been widely acknowledged, programmes for young men remain sparse in highly gender stratified settings such as India, and those that have been implemented have not reached those in rural areas and those out-of-school. Drawing on data from a cluster randomised controlled trial with panel surveys, of a gender-transformative life skills education and sports-coaching programme conducted among young men aged 13-21 who were members of youth clubs, this paper examines the extent to which it transformed the gender role attitudes of young men and instilled in them attitudes rejecting violence against women and girls. The intervention succeeded in changing gender role attitudes and notions of masculinity, attitudes about men's controlling behaviours over women/girls, attitudes about men's perpetration of violence on a woman/girl and perceptions about peer reactions to young men acting in gender-equitable ways. Effects were particularly significant among young men who attended regularly, underscoring the importance of regular attendance in such programmes.",2019,"The intervention succeeded in changing gender role attitudes and notions of masculinity, attitudes about men's controlling behaviours over women/girls, attitudes about men's perpetration of violence on a woman/girl and perceptions about peer reactions to young men acting in gender-equitable ways.","[""women/girls, attitudes about men's perpetration of violence on a woman/girl and perceptions about peer reactions to young men acting in gender-equitable ways"", 'young men aged 13-21 who were members of youth clubs', 'young men who attended regularly, underscoring the importance of regular attendance in such programmes', 'young men and instilled in them attitudes rejecting violence against women and girls']",['gender-transformative life skills education and sports-coaching programme'],[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0562982', 'cui_str': 'Youth club (environment)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C4521682', 'cui_str': 'Instill (administration method)'}, {'cui': 'C4319517', 'cui_str': 'Order rejected (qualifier value)'}, {'cui': 'C0521124', 'cui_str': 'Against (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0335105', 'cui_str': 'Sports coach (occupation)'}]",[],21.0,0.0190474,"The intervention succeeded in changing gender role attitudes and notions of masculinity, attitudes about men's controlling behaviours over women/girls, attitudes about men's perpetration of violence on a woman/girl and perceptions about peer reactions to young men acting in gender-equitable ways.","[{'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Santhya', 'Affiliation': 'Population Council, New Delhi.'}, {'ForeName': 'Shireen J', 'Initials': 'SJ', 'LastName': 'Jejeebhoy', 'Affiliation': 'Population Council, New Delhi.'}, {'ForeName': 'Rajib', 'Initials': 'R', 'LastName': 'Acharya', 'Affiliation': 'Population Council, New Delhi.'}, {'ForeName': 'Neelanjana', 'Initials': 'N', 'LastName': 'Pandey', 'Affiliation': 'Population Council, New Delhi.'}, {'ForeName': 'Aparajita', 'Initials': 'A', 'LastName': 'Gogoi', 'Affiliation': 'Centre for Catalysing Change, New Delhi.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Joshi', 'Affiliation': 'Centre for Catalysing Change, New Delhi.'}, {'ForeName': 'Santosh Kumar', 'Initials': 'SK', 'LastName': 'Singh', 'Affiliation': 'Population Council, New Delhi.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Saxena', 'Affiliation': 'Population Council, New Delhi.'}, {'ForeName': 'Sandeep Kumar', 'Initials': 'SK', 'LastName': 'Ojha', 'Affiliation': 'Centre for Catalysing Change, New Delhi.'}]","Culture, health & sexuality",['10.1080/13691058.2019.1568574']
1744,31246522,"Clofarabine Can Replace Anthracyclines and Etoposide in Remission Induction Therapy for Childhood Acute Myeloid Leukemia: The AML08 Multicenter, Randomized Phase III Trial.","PURPOSE


To identify effective and less toxic therapy for children with acute myeloid leukemia, we introduced clofarabine into the first course of remission induction to reduce exposure to daunorubicin and etoposide.
PATIENTS AND METHODS


From 2008 through 2017, 285 patients were enrolled at eight centers; 262 were randomly assigned to receive clofarabine and cytarabine (Clo+AraC, n = 129) or high-dose cytarabine, daunorubicin, and etoposide (HD-ADE, n = 133) as induction I. Induction II consisted of low-dose ADE given alone or combined with sorafenib or vorinostat. Consolidation therapy comprised two or three additional courses of chemotherapy or hematopoietic cell transplantation. Genetic abnormalities and the level of minimal residual disease (MRD) at day 22 of initial remission induction determined final risk classification. The primary end point was MRD at day 22.
RESULTS


Complete remission was induced after two courses of therapy in 263 (92.3%) of the 285 patients; induction failures included four early deaths and 15 cases of resistant leukemia. Day 22 MRD was positive in 57 of 121 randomly assigned evaluable patients (47%) who received Clo+AraC and 42 of 121 patients (35%) who received HD-ADE (odds ratio, 1.86; 95% CI, 1.03 to 3.41;  P  = .04). Despite this result, the 3-year event-free survival rate (52.9% [44.6% to 62.8%] for Clo+AraC  v  52.4% [44.0% to 62.4%] for HD-ADE,  P  = .94) and overall survival rate (74.8% [67.1% to 83.3%] for Clo+AraC  v  64.6% [56.2% to 74.2%] for HD-ADE,  P  = .1) did not differ significantly across the two arms.
CONCLUSION


Our findings suggest that the use of clofarabine with cytarabine during remission induction might reduce the need for anthracycline and etoposide in pediatric patients with acute myeloid leukemia and may reduce rates of cardiomyopathy and treatment-related cancer.",2019,"Despite this result, the 3-year event-free survival rate (52.9% [44.6% to 62.8%] for Clo+AraC  v  52.4% [44.0% to 62.4%] for HD-ADE,  P  = .94) and overall survival rate (74.8% [67.1% to 83.3%] for Clo+AraC  v  64.6% [56.2% to 74.2%] for HD-ADE,  P  = .1) did not differ significantly across the two arms.
","['Childhood Acute Myeloid Leukemia', 'children with acute myeloid leukemia', 'pediatric patients with acute myeloid leukemia', 'From 2008 through 2017', '285 patients were enrolled at eight centers; 262']","['daunorubicin and etoposide', 'chemotherapy or hematopoietic cell transplantation', 'Clofarabine', 'toxic therapy', 'Clo+AraC', 'clofarabine and cytarabine (Clo+AraC, n = 129) or high-dose cytarabine, daunorubicin, and etoposide (HD-ADE, n = 133) as induction I. Induction II consisted of low-dose ADE given alone or combined with sorafenib or vorinostat', 'Anthracyclines and Etoposide', 'clofarabine with cytarabine', 'clofarabine']","['overall survival rate', 'Genetic abnormalities and the level of minimal residual disease (MRD', '3-year event-free survival rate']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0092777', 'cui_str': 'clofarabine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",285.0,0.106142,"Despite this result, the 3-year event-free survival rate (52.9% [44.6% to 62.8%] for Clo+AraC  v  52.4% [44.0% to 62.4%] for HD-ADE,  P  = .94) and overall survival rate (74.8% [67.1% to 83.3%] for Clo+AraC  v  64.6% [56.2% to 74.2%] for HD-ADE,  P  = .1) did not differ significantly across the two arms.
","[{'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Norman J', 'Initials': 'NJ', 'LastName': 'Lacayo', 'Affiliation': ""2Lucile Packard Children's Hospital and Stanford Cancer Center, Palo Alto, CA.""}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Inaba', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Heym', 'Affiliation': ""3Cook Children's Medical Center, Fort Worth, TX.""}, {'ForeName': 'Raul C', 'Initials': 'RC', 'LastName': 'Ribeiro', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Taub', 'Affiliation': ""4Children's Hospital of Michigan, Detroit, MI.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McNeer', 'Affiliation': '5University of Chicago, Chicago, IL.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Degar', 'Affiliation': '6Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schiff', 'Affiliation': ""7Rady Children's Hospital, San Diego, CA.""}, {'ForeName': 'Allen Eng-Juh', 'Initials': 'AE', 'LastName': 'Yeoh', 'Affiliation': '8National University Health System, Singapore.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Coustan-Smith', 'Affiliation': '8National University Health System, Singapore.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Triplett', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Susana C', 'Initials': 'SC', 'LastName': 'Raimondi', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Klco', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Pounds', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Ching-Hon', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00327']
1745,30475762,Maintain Your Brain: Protocol of a 3-Year Randomized Controlled Trial of a Personalized Multi-Modal Digital Health Intervention to Prevent Cognitive Decline Among Community Dwelling 55 to 77 Year Olds.,"BACKGROUND


Maintain Your Brain (MYB) is a randomized controlled trial of an online multi-modal lifestyle intervention targeting modifiable dementia risk factors with its primary aim being to reduce cognitive decline in an older age cohort.
METHODS


MYB aims to recruit 8,500 non-demented community dwelling 55 to 77 year olds from the Sax Institute's 45 and Up Study in New South Wales, Australia. Participants will be screened for risk factors related to four modules that comprise the MYB intervention: physical activity, nutrition, mental health, and cognitive training. Targeting risk factors will enable interventions to be personalized so that participants receive the most appropriate modules. MYB will run for three years and up to four modules will be delivered sequentially each quarter during year one. Upon completing a module, participants will continue to receive less frequent booster activities for their eligible modules (except for the mental health module) until the end of the trial.
DISCUSSION


MYB will be the largest internet-based trial to attempt to prevent cognitive decline and potentially dementia. If successful, MYB will provide a model for not just effective intervention among older adults, but an intervention that is scalable for broad use.",2019,"BACKGROUND


Maintain Your Brain (MYB) is a randomized controlled trial of an online multi-modal lifestyle intervention targeting modifiable dementia risk factors with its primary aim being to reduce cognitive decline in an older age cohort.
","['Community Dwelling 55 to 77 Year Olds', 'older age cohort', ""8,500 non-demented community dwelling 55 to 77 year olds from the Sax Institute's 45 and Up Study in New South Wales, Australia"", 'older adults', 'Maintain Your Brain']","['Personalized Multi-Modal Digital Health Intervention', 'online multi-modal lifestyle intervention']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]",[],8500.0,0.135194,"BACKGROUND


Maintain Your Brain (MYB) is a randomized controlled trial of an online multi-modal lifestyle intervention targeting modifiable dementia risk factors with its primary aim being to reduce cognitive decline in an older age cohort.
","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Heffernan', 'Affiliation': 'Centre for Healthy Brain Ageing, University of New South Wales, Australia.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Andrews', 'Affiliation': 'Clinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales, Australia.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Fiatarone Singh', 'Affiliation': 'Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Valenzuela', 'Affiliation': 'Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Kaarin J', 'Initials': 'KJ', 'LastName': 'Anstey', 'Affiliation': 'School of Psychology, University of New South Wales, Australia.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Maeder', 'Affiliation': 'College of Nursing & Health Sciences, Flinders University, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McNeil', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Jorm', 'Affiliation': 'Centre for Big Data Research in Health, University of New South Wales, Australia.'}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Lautenschlager', 'Affiliation': 'University of Melbourne, Australia.'}, {'ForeName': 'Perminder S', 'Initials': 'PS', 'LastName': 'Sachdev', 'Affiliation': 'Centre for Healthy Brain Ageing, University of New South Wales, Australia.'}, {'ForeName': 'Jeewani A', 'Initials': 'JA', 'LastName': 'Ginige', 'Affiliation': 'Western Sydney University, Australia.'}, {'ForeName': 'Megan J', 'Initials': 'MJ', 'LastName': 'Hobbs', 'Affiliation': 'Clinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales, Australia.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Boulamatsis', 'Affiliation': 'Western Sydney University, Australia.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Chau', 'Affiliation': 'Centre for Healthy Brain Ageing, University of New South Wales, Australia.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Cobiac', 'Affiliation': 'CSIRO Health and Biosecurity.'}, {'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Daniel', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Flood', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Yareni', 'Initials': 'Y', 'LastName': 'Guerrero', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Gunn', 'Affiliation': 'Department of General Practice, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Kochan', 'Affiliation': 'Centre for Healthy Brain Ageing, University of New South Wales, Australia.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Lampit', 'Affiliation': 'Brain and Mind Centre, University of Sydney, Australia.'}, {'ForeName': 'Yorgi', 'Initials': 'Y', 'LastName': 'Mavros', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Jacinda', 'Initials': 'J', 'LastName': 'Meiklejohn', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Yian', 'Initials': 'Y', 'LastName': 'Noble', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': ""O'Leary"", 'Affiliation': 'Nutrition and Dietetics Group, School of Life and Environmental Science, Faculty of Science & The Charles Perkins Centre, University of Sydney, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Radd-Vagenas', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, Faculty of Health Sciences, University of Sydney, Australia.'}, {'ForeName': 'Courtney C', 'Initials': 'CC', 'LastName': 'Walton', 'Affiliation': 'Brain and Mind Centre, University of Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Brodaty', 'Affiliation': 'Centre for Healthy Brain Ageing, University of New South Wales, Australia.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-180572']
1746,31693879,The DAPA-HF Trial: A Momentous Victory in the War against Heart Failure.,"In a randomized trial of patients with heart failure and reduced ejection fraction, the SGLT2 inhibitor dapagliflozin markedly reduced mortality and worsening heart failure (McMurray et al., 2019). Remarkably, these benefits seemed to be similar in people with and without diabetes. These data usher in a new paradigm in the treatment of heart failure.",2019,"In a randomized trial of patients with heart failure and reduced ejection fraction, the SGLT2 inhibitor dapagliflozin markedly reduced mortality and worsening heart failure","['patients with heart failure and reduced ejection fraction, the']",['SGLT2 inhibitor dapagliflozin'],['mortality and worsening heart failure'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",,0.0299736,"In a randomized trial of patients with heart failure and reduced ejection fraction, the SGLT2 inhibitor dapagliflozin markedly reduced mortality and worsening heart failure","[{'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: dlbhattmd@post.harvard.edu.""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Departments of Surgery, and Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",Cell metabolism,['10.1016/j.cmet.2019.10.008']
1747,30716716,"Angiotensin II receptor blockers, steroids and radiotherapy in glioblastoma-a randomised multicentre trial (ASTER trial). An ANOCEF study.","BACKGROUND


Glioblastomas (GBMs) induce a peritumoural vasogenic oedema impairing functional status and quality of life. Steroids reduce brain tumour-related oedema but are associated with numerous side-effects. It was reported in a retrospective series that angiotensin receptor blockers might be associated with reduced peritumoural oedema. The ASTER study is a randomised, placebo-controlled trial to assess whether or not the addition of Losartan to standard of care (SOC) can reduce steroid requirement during radiotherapy (RT) in patients with newly diagnosed GBM.
PATIENTS AND METHODS


Patients with a histologically confirmed GBM after biopsy or partial surgical resection were randomised between Losartan or placebo in addition to SOC with RT and temozolomide (TMZ). The primary objective was to investigate the steroid dosage required to control brain oedema on the last day of RT in each arm. The secondary outcomes were steroids dosage 1 month after the end of RT, assessment of cerebral oedema on magnetic resonance imaging, tolerance and survival.
RESULTS


Seventy-five patients were randomly assigned to receive Losartan (37 patients) or placebo (38 patients). No difference in the steroid dosage required to control brain oedema on the last day of RT, or one month after completion of RT, was seen between both arms. The incidence of adverse events was similar in both arms. Median overall survival was similar in both arms.
CONCLUSIONS


Losartan, although well tolerated, does not reduce the steroid requirement in newly diagnosed GBM patients treated with concomitant RT and TMZ. Trial registration number NCT01805453 with ClinicalTrials.gov.",2019,"No difference in the steroid dosage required to control brain oedema on the last day of RT, or one month after completion of RT, was seen between both arms.","['Seventy-five patients', 'Patients with a histologically confirmed GBM after biopsy or partial surgical resection', 'patients with newly diagnosed GBM', 'newly diagnosed GBM patients treated with']","['placebo', 'Angiotensin II receptor blockers, steroids and radiotherapy', 'Losartan', 'Losartan to standard of care (SOC', 'Losartan or placebo', 'radiotherapy (RT', 'SOC with RT and temozolomide (TMZ', 'concomitant RT and TMZ', 'angiotensin receptor blockers']","['adverse events', 'steroids dosage 1 month after the end of RT, assessment of cerebral oedema on magnetic resonance imaging, tolerance\xa0and survival', 'steroid requirement', 'Median overall survival', 'control brain oedema']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003011', 'cui_str': 'Receptor, Angiotensin II'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0006114', 'cui_str': 'Cerebral Edema'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1527311', 'cui_str': 'Intracranial Edema'}]",75.0,0.251425,"No difference in the steroid dosage required to control brain oedema on the last day of RT, or one month after completion of RT, was seen between both arms.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ursu', 'Affiliation': 'Department of Neurology, Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France; University Paris Diderot, Sorbonne Paris Cité, Paris, France. Electronic address: renata.ursu@aphp.fr.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Department of Neuro-Oncology, Hospices Civils de Lyon, Groupe Hospitalier Est, Lyon, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Psimaras', 'Affiliation': 'Department of Neurology Mazarin, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Chinot', 'Affiliation': 'Department of Neuro-Oncology, CHU Timone, Marseille, France; Aix-Marseille Université, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Le Rhun', 'Affiliation': 'University of Lille, Inserm, U-1192, F-59000 Lille, France; CHU Lille, General and Stereotaxic Neurosurgery Service, F-59000 Lille, France; Oscar Lambret Center, Neurology, Medical Oncology Department, F-59000 Lille, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ricard', 'Affiliation': ""Department of Neurology, Hôpital d'Instruction des Armées Percy, Service de Santé des Armées, Paris, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Charissoux', 'Affiliation': 'Department of Radiation Oncology, Institut du Cancer de Montpellier, Montpellier cedex 5, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cuzzubbo', 'Affiliation': 'Department of Neurology, Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France; University Paris Diderot, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sejalon', 'Affiliation': 'Department of Neurology, Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Quillien', 'Affiliation': 'Centre de Lutte Contre le Cancer Eugène Marquis, F-35042 Rennes, France; INSERM U1242, ""Chemistry, Oncogenesis, Stress, Signaling"", Université de Rennes 1, Rennes, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hoang-Xuan', 'Affiliation': 'Department of Neurology Mazarin, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ducray', 'Affiliation': 'Department of Neuro-Oncology, Hospices Civils de Lyon, Groupe Hospitalier Est, Lyon, France; Department of Cancer Cell Plasticity, Cancer Research Centre of Lyon, INSERM U1052, CNRS UMR5286, Lyon, France; University Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'J-J', 'Initials': 'JJ', 'LastName': 'Portal', 'Affiliation': 'AP-HP, Unité de Recherche Clinique, Hôpital Fernand Widal, Université Paris-Diderot, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tibi', 'Affiliation': 'Agence Générale des Equipements et Produits de Santé (AGEPS), Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mandonnet', 'Affiliation': 'Department of Neurosurgery, Lariboisière Hospital, APHP, Paris, France; University Paris 7, Paris, France; IMNC, UMR 8165, Orsay, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Levy-Piedbois', 'Affiliation': 'Ramsey Générale de Santé, Institut de Radiothérapie des Hauts-Energies, Bobigny, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'AP-HP, Unité de Recherche Clinique, Hôpital Fernand Widal, Université Paris-Diderot, Paris, France.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Carpentier', 'Affiliation': 'Department of Neurology, Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France; University Paris Diderot, Sorbonne Paris Cité, Paris, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2018.12.025']
1748,30570761,Perioperative intravenous ketamine for acute postoperative pain in adults.,"BACKGROUND


Inadequate pain management after surgery increases the risk of postoperative complications and may predispose for chronic postsurgical pain. Perioperative ketamine may enhance conventional analgesics in the acute postoperative setting.
OBJECTIVES


To evaluate the efficacy and safety of perioperative intravenous ketamine in adult patients when used for the treatment or prevention of acute pain following general anaesthesia.
SEARCH METHODS


We searched CENTRAL, MEDLINE and Embase to July 2018 and three trials registers (metaRegister of controlled trials, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP)) together with reference checking, citation searching and contact with study authors to identify additional studies.
SELECTION CRITERIA


We sought randomised, double-blind, controlled trials of adults undergoing surgery under general anaesthesia and being treated with perioperative intravenous ketamine. Studies compared ketamine with placebo, or compared ketamine plus a basic analgesic, such as morphine or non-steroidal anti-inflammatory drug (NSAID), with a basic analgesic alone.
DATA COLLECTION AND ANALYSIS


Two review authors searched for studies, extracted efficacy and adverse event data, examined issues of study quality and potential bias, and performed analyses. Primary outcomes were opioid consumption and pain intensity at rest and during movement at 24 and 48 hours postoperatively. Secondary outcomes were time to first analgesic request, assessment of postoperative hyperalgesia, central nervous system (CNS) adverse effects, and postoperative nausea and vomiting. We assessed the evidence using GRADE and created a 'Summary of findings' table.
MAIN RESULTS


We included 130 studies with 8341 participants. Ketamine was given to 4588 participants and 3753 participants served as controls. Types of surgery included ear, nose or throat surgery, wisdom tooth extraction, thoracotomy, lumbar fusion surgery, microdiscectomy, hip joint replacement surgery, knee joint replacement surgery, anterior cruciate ligament repair, knee arthroscopy, mastectomy, haemorrhoidectomy, abdominal surgery, radical prostatectomy, thyroid surgery, elective caesarean section, and laparoscopic surgery. Racemic ketamine bolus doses were predominantly 0.25 mg to 1 mg, and infusions 2 to 5 µg/kg/minute; 10 studies used only S-ketamine and one only R-ketamine. Risk of bias was generally low or uncertain, except for study size; most had fewer than 50 participants per treatment arm, resulting in high heterogeneity, as expected, for most analyses. We did not stratify the main analysis by type of surgery or any other factor, such as dose or timing of ketamine administration, and used a non-stratified analysis.Perioperative intravenous ketamine reduced postoperative opioid consumption over 24 hours by 8 mg morphine equivalents (95% CI 6 to 9; 19% from 42 mg consumed by participants given placebo, moderate-quality evidence; 65 studies, 4004 participants). Over 48 hours, opioid consumption was 13 mg lower (95% CI 10 to 15; 19% from 67 mg with placebo, moderate-quality evidence; 37 studies, 2449 participants).Perioperative intravenous ketamine reduced pain at rest at 24 hours by 5/100 mm on a visual analogue scale (95% CI 4 to 7; 19% lower from 26/100 mm with placebo, high-quality evidence; 82 studies, 5004 participants), and at 48 hours by 5/100 mm (95% CI 3 to 7; 22% lower from 23/100 mm, high-quality evidence; 49 studies, 2962 participants). Pain during movement was reduced at 24 hours (6/100 mm, 14% lower from 42/100 mm, moderate-quality evidence; 29 studies, 1806 participants), and 48 hours (6/100 mm, 16% lower from 37 mm, low-quality evidence; 23 studies, 1353 participants).Results for primary outcomes were consistent when analysed by pain at rest or on movement, operation type, and timing of administration, or sensitivity to study size and pain intensity. No analysis by dose was possible. There was no difference when nitrous oxide was used. We downgraded the quality of the evidence once if numbers of participants were large but small-study effects were present, or twice if numbers were small and small-study effects likely but testing not possible.Ketamine increased the time for the first postoperative analgesic request by 54 minutes (95% CI 37 to 71 minutes), from a mean of 39 minutes with placebo (moderate-quality evidence; 31 studies, 1678 participants). Ketamine reduced the area of postoperative hyperalgesia by 7 cm² (95% CI -11.9 to -2.2), compared with placebo (very low-quality evidence; 7 studies 333 participants). We downgraded the quality of evidence because of small-study effects or because the number of participants was below 400.CNS adverse events occurred in 52 studies, while 53 studies reported of absence of CNS adverse events. Overall, 187/3614 (5%) participants receiving ketamine and 122/2924 (4%) receiving control treatment experienced an adverse event (RR 1.2, 95% CI 0.95 to 1.4; high-quality evidence; 105 studies, 6538 participants). Ketamine reduced postoperative nausea and vomiting from 27% with placebo to 23% with ketamine (RR 0.88, 95% CI 0.81 to 0.96; the number needed to treat to prevent one episode of postoperative nausea and vomiting with perioperative intravenous ketamine administration was 24 (95% CI 16 to 54; high-quality evidence; 95 studies, 5965 participants).
AUTHORS' CONCLUSIONS


Perioperative intravenous ketamine probably reduces postoperative analgesic consumption and pain intensity. Results were consistent in different operation types or timing of ketamine administration, with larger and smaller studies, and by higher and lower pain intensity. CNS adverse events were little different with ketamine or control. Perioperative intravenous ketamine probably reduces postoperative nausea and vomiting by a small extent, of arguable clinical relevance.",2018,"Ketamine reduced postoperative nausea and vomiting from 27% with placebo to 23% with ketamine (RR 0.88, 95% CI 0.81 to 0.96; the number needed to treat to prevent one episode of postoperative nausea and vomiting with perioperative intravenous ketamine administration was 24 (95% CI 16 to 54; high-quality evidence; 95 studies, 5965 participants).
","['and Embase to July 2018 and three trials registers (metaRegister of controlled trials, ClinicalTrials.gov and the World Health Organization (WHO', 'acute postoperative pain in adults', 'adult patients when used for the treatment or prevention of acute pain following general anaesthesia', 'adults undergoing surgery under general anaesthesia and being treated with perioperative intravenous', '130 studies with 8341 participants', '4588 participants and 3753 participants served as controls']","['ketamine', 'lumbar fusion surgery, microdiscectomy, hip joint replacement surgery, knee joint replacement surgery, anterior cruciate ligament repair, knee arthroscopy, mastectomy, haemorrhoidectomy, abdominal surgery, radical prostatectomy, thyroid surgery, elective caesarean section, and laparoscopic surgery', 'placebo', 'perioperative intravenous ketamine', 'morphine', 'Ketamine', 'ketamine with placebo', 'Racemic ketamine', 'Perioperative ketamine', 'ketamine and one only R-ketamine']","['postoperative analgesic consumption and pain intensity', 'opioid consumption', 'postoperative opioid consumption', 'pain', 'time for the first postoperative analgesic request', 'time to first analgesic request, assessment of postoperative hyperalgesia, central nervous system (CNS) adverse effects, and postoperative nausea and vomiting', 'visual analogue scale', 'pain at rest or on movement, operation type, and timing of administration, or sensitivity to study size and pain intensity', 'opioid consumption and pain intensity at rest and during movement at 24 and 48 hours postoperatively', 'area of postoperative hyperalgesia', 'Pain during movement', 'postoperative nausea and vomiting', 'pain intensity', 'efficacy and safety', 'CNS adverse events', 'adverse event']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0457629', 'cui_str': 'Lumbar microdiscectomy (procedure)'}, {'cui': 'C0019558', 'cui_str': 'Acetabulofemoral Joint'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0078960', 'cui_str': 'Anterior Cranial Cruciate Ligament'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",333.0,0.730471,"Ketamine reduced postoperative nausea and vomiting from 27% with placebo to 23% with ketamine (RR 0.88, 95% CI 0.81 to 0.96; the number needed to treat to prevent one episode of postoperative nausea and vomiting with perioperative intravenous ketamine administration was 24 (95% CI 16 to 54; high-quality evidence; 95 studies, 5965 participants).
","[{'ForeName': 'Elina Cv', 'Initials': 'EC', 'LastName': 'Brinck', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Division of Anesthesiology, Töölö Hospital, Helsinki University and Helsinki University Hospital, Topeliuksenkatu 5, Helsinki, Finland, PB 266 00029.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Tiippana', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heesen', 'Affiliation': ''}, {'ForeName': 'Rae Frances', 'Initials': 'RF', 'LastName': 'Bell', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Straube', 'Affiliation': ''}, {'ForeName': 'R Andrew', 'Initials': 'RA', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Kontinen', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012033.pub4']
1749,32407655,Methodology Matters: The Impact of Research Design on Conversational Entrainment Outcomes.,"Purpose Conversational entrainment describes the tendency for individuals to alter their communicative behaviors to more closely align with those of their conversation partner. This communication phenomenon has been widely studied, and thus, the methodologies used to examine it are diverse. Here, we summarize key differences in research design and present a test case to examine the effect of methodology on entrainment outcomes. Method Sixty neurotypical adults were randomly assigned to experimental groups formed by a 2 × 2 factorial combination of two independent variables: stimuli organization (blocked vs. random presentation) and stimuli modality (auditory-only vs. audiovisual stimuli). Individuals participated in a quasiconversational design in which the speech of a virtual interlocutor was manipulated to produce fast and slow speech rate conditions. Results There was a significant effect of stimuli organization on entrainment outcomes. Individuals in the blocked, but not the random, groups altered their speech rate to align with the speech rate of the virtual interlocutor. There were no effect of stimuli modality and no interaction between modality and organization on entrainment outcomes. Conclusion Findings highlight the importance of methodological decisions on entrainment outcomes. This underscores the need for more comprehensive research regarding entrainment methodology.",2020,There were no effect of stimuli modality and no interaction between modality and organization on entrainment outcomes.,"['Method Sixty neurotypical adults', 'Methodology Matters']",['stimuli organization (blocked vs. random presentation) and stimuli modality (auditory-only vs. audiovisual stimuli'],[],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0969625', 'cui_str': 'methodology'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]",[],60.0,0.0260353,There were no effect of stimuli modality and no interaction between modality and organization on entrainment outcomes.,"[{'ForeName': 'Camille J', 'Initials': 'CJ', 'LastName': 'Wynn', 'Affiliation': 'Department of Communicative Disorders and Deaf Education, Utah State University, Logan.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Borrie', 'Affiliation': 'Department of Communicative Disorders and Deaf Education, Utah State University, Logan.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-19-00243']
1750,31666344,"Prolonged survival in the absence of disease-recurrence in advanced-stage follicular lymphoma following chemo-immunotherapy: 13-year update of the prospective, multicenter randomized GITMO-IIL trial.","A prospective trial conducted in the period 2000-2005 showed no survival advantage for high-dose chemotherapy with rituximab and autograft (R-HDS)  versus  conventional chemotherapy with rituximab (CHOP-R) as first-line therapy in 134 high-risk follicular lymphoma patients aged <60 years. The study has been updated at the 13-year median follow up. As of February 2017, 88 (66%) patients were alive, with overall survival of 66.4% at 13 years, without a significant difference between R-HDS (64.5%) and CHOP-R (68.5%). To date, 46 patients have died, mainly because of disease progression (47.8% of all deaths), secondary malignancies (3 solid tumor, 9 myelodysplasia/acute leukemia; 26.1% of all deaths), and other toxicities (21.7% of all deaths). Complete remission was documented in 98 (73.1%) patients and associated with overall survival, with 13-year estimates of 77.0% and 36.8% for complete remission  versus  no-complete remission, respectively. Molecular remission was documented in 39 (65%) out of 60 evaluable patients and associated with improved survival. In multivariate analysis, complete remission achievement had the strongest effect on survival ( P <0.001), along with younger age ( P =0.002) and female sex ( P =0.013). Overall, 50 patients (37.3%) survived with no disease recurrence (18 CHOP-R, 32 R-HDS). This follow up is the longest reported on follicular lymphoma treated upfront with rituximab-chemotherapy and demonstrates an unprecedented improvement in survival compared to the pre-rituximab era, regardless of the use of intensified or conventional treatment. Complete remission was the most important factor for prolonged survival and a high proportion of patients had prolonged survival in their first remission, raising the issue of curability in follicular lymphoma. (Registered at clinicaltrials.gov identifier: 00435955).",2019,"Complete remission was the most important factor for prolonged survival and a high proportion of patients had prolonged survival in their first remission, raising the issue of curability in follicular lymphoma.","['134 high-risk follicular lymphoma patients aged <60 years', '46 patients have died, mainly because of disease progression (47.8% of all deaths), secondary malignancies (3 solid tumor, 9 myelodysplasia/acute leukemia; 26.1% of all deaths), and other toxicities (21.7% of all deaths']","['rituximab-chemotherapy', 'chemotherapy with rituximab and autograft (R-HDS)  versus  conventional chemotherapy with rituximab (CHOP-R']","['Complete remission', 'survival', 'prolonged survival', 'Prolonged survival', 'Molecular remission', 'survival advantage', 'overall survival', 'disease recurrence']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia, morphology, including blast cell OR undifferentiated leukemia (morphologic abnormality)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}]",134.0,0.244075,"Complete remission was the most important factor for prolonged survival and a high proportion of patients had prolonged survival in their first remission, raising the issue of curability in follicular lymphoma.","[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Bruna', 'Affiliation': 'Onco-Hematology Division, IEO, European Institute of Oncology IRCCS, Milano.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Benedetti', 'Affiliation': 'Hematology University Division, Verona.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Boccomini', 'Affiliation': 'Hematology Division, Città della Salute Hospital, Torino.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Patti', 'Affiliation': 'Hematology Division, Azienda Villa Sofia-Cervello, Palermo.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Barbui', 'Affiliation': 'Hematology Division, Papa Giovanni XXIII Hospital, Bergamo.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Pulsoni', 'Affiliation': 'Department of Cellular Biotechnologies and Hematology, La Sapienza University, Roma.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Musso', 'Affiliation': 'Hematology Unit, La Maddalena Hospital, Palermo.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'SC Oncoematologia, Università degli Studi di Perugia.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Gini', 'Affiliation': 'Hematology University Division, Ancona.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Castellino', 'Affiliation': 'Department of Hematology, S. Croce e Carle Hospital, Cuneo.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Rossini', 'Affiliation': 'Hematology University Division, Monza.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ciceri', 'Affiliation': 'Hematology Unit HSR, Milano.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Rota-Scalabrini', 'Affiliation': 'Oncologia Medica, Cancer Institute FPO, IRCCS, Candiolo.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Stelitano', 'Affiliation': 'Hematology Division, Reggio Calabria.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Di Raimondo', 'Affiliation': 'Hematology Univiversity Division, Catania.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tucci', 'Affiliation': 'Division of Hematology, Brescia.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Devizzi', 'Affiliation': 'University Division of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Zoli', 'Affiliation': 'Hematology Division, S. Camillo Hospital, Roma.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Zallio', 'Affiliation': 'SC Ematologia AO SS Antonio e Biagio e Cesare Arrigo, Alessandria.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Narni', 'Affiliation': 'Hematology University Division, Modena.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Dondi', 'Affiliation': 'Division of Oncology, Modena.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Parvis', 'Affiliation': 'Division of Internal Medicine, S. Luigi Hospital, Orbassano.'}, {'ForeName': 'Gianpietro', 'Initials': 'G', 'LastName': 'Semenzato', 'Affiliation': 'Hematology University Division, Padova.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Lanza', 'Affiliation': 'Hematology Unit, Cremona.'}, {'ForeName': 'Tommasina', 'Initials': 'T', 'LastName': 'Perrone', 'Affiliation': 'Hematology University Division, Bari.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Angrilli', 'Affiliation': 'Hematology Division, Pescara.'}, {'ForeName': 'Atto', 'Initials': 'A', 'LastName': 'Billio', 'Affiliation': 'Hematology Division, Bolzano.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Gueli', 'Affiliation': 'Onco-Hematology Division, IEO, European Institute of Oncology IRCCS, Milano.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mantoan', 'Affiliation': 'Hematology University Division, Città della Salute Hospital, Torino.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rambaldi', 'Affiliation': 'Hematology Division, Papa Giovanni XXIII Hospital, Bergamo.'}, {'ForeName': 'Alessandro Massimo', 'Initials': 'AM', 'LastName': 'Gianni', 'Affiliation': 'Onco-Hematology Division, IEO, European Institute of Oncology IRCCS, Milano.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corradini', 'Affiliation': 'University Division of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Passera', 'Affiliation': 'Nuclear Medicine Division, Città della Salute Hospital, Torino.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ladetto', 'Affiliation': 'SC Ematologia AO SS Antonio e Biagio e Cesare Arrigo, Alessandria.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Tarella', 'Affiliation': 'Onco-Hematology Division, IEO, European Institute of Oncology IRCCS, Milano corrado.tarella@unimi.it.'}]",Haematologica,['10.3324/haematol.2018.209932']
1751,30332542,An agriculture-nutrition intervention improved children's diet and growth in a randomized trial in Ghana.,"Stunting in Ghana is associated with rural communities, poverty, and low education; integrated agricultural interventions can address the problem. This cluster randomized controlled trial tested the effect of a 12-month intervention (inputs and training for poultry farming and home gardening, and nutrition and health education) on child diet and nutritional status. Sixteen clusters were identified and randomly assigned to intervention or control; communities within clusters were randomly chosen, and all interested, eligible mother-child pairs were enrolled (intervention: 8 clusters, 19 communities, and 287 households; control: 8 clusters, 20 communities, and 213 households). Intention-to-treat analyses were used to estimate the effect of the intervention on endline minimum diet diversity (≥4 food groups), consumption of eggs, and length-for-age (LAZ)/height-for-age (HAZ), weight-for-age (WAZ), and weight-for-length (WLZ)/weight-for-height (WHZ) z-scores; standard errors were corrected for clustering. Children were 10.5 ± 5.2 months (range: 0-32) at baseline and 29.8 ± 5.4 months (range: 13-48) at endline. Compared with children in the control group, children in the intervention group met minimum diet diversity (adjusted odds ratio = 1.65, 95% CI [1.02, 2.69]) and a higher LAZ/HAZ (β = 0.22, 95% CI [0.09, 0.34]) and WAZ (β = 0.15, 95% CI [0.00, 0.30]). Sensitivity analyses with random-effects and mixed-effects models and as-treated analysis were consistent with the findings. There was no group difference in WLZ/WHZ. Integrated interventions that increase access to high-quality foods and nutrition education improve child nutrition.",2018,"Compared with children in the control group, children in the intervention group met minimum diet diversity (adjusted odds ratio = 1.65, 95% CI [1.02, 2.69]) and a higher LAZ/HAZ (β = 0.22, 95% CI [0.09, 0.34]) and WAZ (β = 0.15, 95% CI [0.00, 0.30]).","[""children's diet and growth in a randomized trial in Ghana"", 'Children were 10.5\xa0±\xa05.2\xa0months (range: 0-32) at baseline and 29.8\xa0±', 'Sixteen clusters were identified and randomly assigned to intervention or control; communities within clusters were randomly chosen, and all interested, eligible mother-child pairs were enrolled (intervention: 8 clusters, 19 communities, and 287 households; control: 8 clusters, 20 communities, and 213 households']","['agriculture-nutrition intervention', 'intervention (inputs and training for poultry farming and home gardening, and nutrition and health education']","['minimum diet diversity', 'consumption of eggs, and length-for-age (LAZ)/height-for-age (HAZ), weight-for-age (WAZ), and weight-for-length (WLZ)/weight-for-height (WHZ) z-scores; standard errors', 'WLZ/WHZ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C0001829', 'cui_str': 'Farming'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0452888', 'cui_str': 'Poultry (substance)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C0018701'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",16.0,0.0586361,"Compared with children in the control group, children in the intervention group met minimum diet diversity (adjusted odds ratio = 1.65, 95% CI [1.02, 2.69]) and a higher LAZ/HAZ (β = 0.22, 95% CI [0.09, 0.34]) and WAZ (β = 0.15, 95% CI [0.00, 0.30]).","[{'ForeName': 'Grace S', 'Initials': 'GS', 'LastName': 'Marquis', 'Affiliation': 'School of Human Nutrition, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Esi K', 'Initials': 'EK', 'LastName': 'Colecraft', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Legon, Ghana.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Kanlisi', 'Affiliation': 'Heifer International, Accra, Ghana.'}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Aidam', 'Affiliation': 'Evidence and Learning Unit, World Vision International, Washington, DC, USA.'}, {'ForeName': 'Afua', 'Initials': 'A', 'LastName': 'Atuobi-Yeboah', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Legon, Ghana.'}, {'ForeName': 'Comfort', 'Initials': 'C', 'LastName': 'Pinto', 'Affiliation': 'Heifer International, Accra, Ghana.'}, {'ForeName': 'Richmond', 'Initials': 'R', 'LastName': 'Aryeetey', 'Affiliation': 'School of Public Health, University of Ghana, Legon, Ghana.'}]",Maternal & child nutrition,['10.1111/mcn.12677']
1752,31290965,"Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1).","BACKGROUND


About one-third of patients with depression fail to achieve remission despite treatment with multiple antidepressants and are considered to have treatment-resistant depression.
METHODS


This Phase 3, double-blind, multicenter study enrolled adults with moderate-to-severe depression and nonresponse to ≥2 antidepressants in the current depression episode. Eligible patients (N = 346) were randomized (1:1:1) to twice-weekly nasal spray treatment (esketamine [56 or 84 mg] or placebo) plus a newly initiated, open-label, oral antidepressant taken daily for 4 weeks. The primary efficacy endpoint was change from baseline to day 28 in the Montgomery-Asberg Depression Rating Scale total score, performed by blinded, remote raters. Based on the predefined statistical testing sequence, esketamine 84 mg/antidepressant had to be significant for esketamine 56 mg/antidepressant to be formally tested.
RESULTS


Statistical significance was not achieved with esketamine 84 mg/antidepressant compared with antidepressant/placebo (least squares [LS] means difference [95% CI]: -3.2 [-6.88, 0.45]; 2-sided P value = .088). Although esketamine 56 mg/antidepressant could not be formally tested, the LS means difference was -4.1 [-7.67, -0.49] (nominal 2-sided P value = .027). The most common (>20%) adverse events reported for esketamine/antidepressant were nausea, dissociation, dizziness, vertigo, and headache.
CONCLUSIONS


Statistical significance was not achieved for the primary endpoint; nevertheless, the treatment effect (Montgomery-Asberg Depression Rating Scale) for both esketamine/antidepressant groups exceeded what has been considered clinically meaningful for approved antidepressants vs placebo. Safety was similar between esketamine/antidepressant groups and no new dose-related safety concerns were identified. This study provides supportive evidence for the safety and efficacy of esketamine nasal spray as a new, rapid-acting antidepressant for patients with treatment-resistant depression.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02417064.",2019,"CONCLUSIONS


Statistical significance was not achieved for the primary endpoint; nevertheless, the treatment effect (MADRS) for both esketamine/antidepressant groups exceeded what has been considered clinically meaningful for approved antidepressants versus placebo.","['Treatment-Resistant Depression', 'multicenter study enrolled adults with moderate-to-severe depression and non-response to ≥2 antidepressants in the current depression episode', 'Eligible patients (N=346', 'patients with TRD']","['nasal spray treatment (esketamine [56 or 84 mg] or placebo) plus a newly-initiated, open-label, oral antidepressant taken daily for 4 weeks', 'placebo', 'esketamine nasal spray']","['Efficacy and Safety', 'nausea, dissociation, dizziness, vertigo, and headache', 'change from baseline to Day 28 in Montgomery-Asberg Depression Rating Scale (MADRS) total score, performed by blinded, remote raters', 'Safety']","[{'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2825616'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0086168', 'cui_str': 'Dissociation'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}]",346.0,0.183987,"CONCLUSIONS


Statistical significance was not achieved for the primary endpoint; nevertheless, the treatment effect (MADRS) for both esketamine/antidepressant groups exceeded what has been considered clinically meaningful for approved antidepressants versus placebo.","[{'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Fedgchin', 'Affiliation': 'Janssen Research and Development, Department of Neuroscience, Titusville, New Jersey.'}, {'ForeName': 'Madhukar', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Psychiatry, Dallas, Texas.'}, {'ForeName': 'Ella J', 'Initials': 'EJ', 'LastName': 'Daly', 'Affiliation': 'Janssen Research and Development, Department of Neuroscience, Titusville, New Jersey.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Melkote', 'Affiliation': 'Janssen Research and Development, Clinical Biostatistics, Titusville, New Jersey.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Lane', 'Affiliation': 'Janssen Research and Development, Clinical Biostatistics, Titusville, New Jersey.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Lim', 'Affiliation': 'Janssen Research and Development, Clinical Biostatistics, Titusville, New Jersey.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Vitagliano', 'Affiliation': 'Janssen Research and Development, Department of Neuroscience, Titusville, New Jersey.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blier', 'Affiliation': 'University of Ottawa, Departments of Psychiatry and Cellular & Molecular Medicine, Ottawa, Ontario, Canada.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Clinical Trials Network and Institute, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Liebowitz', 'Affiliation': 'The Medical Research Network, LLC, New York, New York.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Ravindran', 'Affiliation': 'Institute of Medical Sciences, University of Toronto, Department of Psychiatry, Toronto, Ontario, Canada.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Gaillard', 'Affiliation': 'Centre Hospitalier Sainte Anne, Service Hospitalo-Universitaire, Paris, France.'}, {'ForeName': 'Hans Van Den', 'Initials': 'HVD', 'LastName': 'Ameele', 'Affiliation': 'AZ Sint-Jan Brugge-Oostende, Department of Psychiatry, Brugge, Belgium.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Preskorn', 'Affiliation': 'University of Kansas School of Medicine-Wichita, Wichita, Kansas.'}, {'ForeName': 'Husseini', 'Initials': 'H', 'LastName': 'Manji', 'Affiliation': 'Janssen Research and Development, Department of Neuroscience, Titusville, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hough', 'Affiliation': 'Janssen Research and Development, Department of Neuroscience, Titusville, New Jersey.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Janssen Research and Development, Department of Neuroscience, San Diego, California.'}, {'ForeName': 'Jaskaran B', 'Initials': 'JB', 'LastName': 'Singh', 'Affiliation': 'Janssen Research and Development, Department of Neuroscience, San Diego, California.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyz039']
1753,32408065,Spending the night next to a router - Results from the first human experimental study investigating the impact of Wi-Fi exposure on sleep.,"BACKGROUND


The use of wireless telecommunication systems such as wireless fidelity (Wi-Fi)-enabled devices has steadily increased in recent years. There are persistent concerns that radiofrequency electromagnetic field (RF-EMF) exposure might affect health. Possible effects of RF-EMF exposure on human sleep were examined with regard to mobile phones and base stations, but not with regard to Wi-Fi exposure.
OBJECTIVES


The present double-blind, sham-controlled, randomized, fully counterbalanced cross-over study addressed for the first time the question whether a whole night Wi-Fi exposure has an effect on sleep.
METHODS


Thirty-four healthy young male subjects (mean ± SD: 24.1 ± 2.9 years) spent five nights in the sleep laboratory. A screening and adaptation night was followed by two experimental nights. Each of the experimental nights was preceded by a baseline night. Sleep was evaluated at the subjective level by a questionnaire and at the objective level (macro- and microstructure) by polysomnography. Either 2.45 GHz Wi-Fi (max psSAR10g of 6.4 mW/kg) or sham signals were delivered by a newly developed head exposure facility.
RESULTS


Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep. Analyses of the microstructure of sleep revealed a reduction in global EEG power in the alpha frequency band (8.00-11.75 Hz) during NREM sleep under acute Wi-Fi exposure compared to sham.
DISCUSSION


The results of the present human experimental study are well in line with several other neurophysiological studies showing that acute RF-EMF exposure has no effect on the macrostructure of sleep. The slight physiological changes in EEG power observed under Wi-Fi exposure are neither reflected in the subjective assessment of sleep nor at the level of objective measurements. The present results are not indicative of a sleep disturbing effect of Wi-Fi exposure.",2020,"RESULTS


Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep.",['Thirty-four healthy young male subjects (mean\xa0±\xa0SD: 24.1\xa0±\xa02.9 years) spent five nights in the sleep laboratory'],"['GHz Wi-Fi', 'RF-EMF exposure', 'radiofrequency electromagnetic field (RF-EMF']","['subjective sleep parameters', 'global EEG power', 'Sleep']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0556961', 'cui_str': 'GHz'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",34.0,0.0200575,"RESULTS


Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Danker-Hopfe', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany. Electronic address: heidi.danker-hopfe@charite.de.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Bueno-Lopez', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Dorn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Schmid', 'Affiliation': 'Seibersdorf Laboratories, 2444, Seibersdorf, Austria.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Hirtl', 'Affiliation': 'Seibersdorf Laboratories, 2444, Seibersdorf, Austria.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Eggert', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}]",International journal of hygiene and environmental health,['10.1016/j.ijheh.2020.113550']
1754,30500336,Self-administered lidocaine gel for local anesthesia prior to osmotic dilator placement: a randomized trial.,"OBJECTIVE(S)


To compare pain scores during cervical dilator placement prior to dilation and evacuation (D&E) with patient-administered vaginal lidocaine gel versus lidocaine paracervical block (PCB).
STUDY DESIGN


We conducted an unblinded randomized trial of women ≥18 years of age undergoing surgical abortion at ≥16 weeks' gestation in two outpatient clinics. We randomized participants to receive self-administered lidocaine gel 2% 20 mL intravaginally 15-30 min before procedure initiation or lidocaine 1% 12 mL PCB immediately prior to dilator placement. Participants rated their pain at various time points using a visual analog scale (VAS), including anticipated and baseline pain, speculum insertion, tenaculum placement, cervical dilator placement (primary outcome) and speculum removal.
RESULTS


We enrolled 72 women and analyzed data for 69 participants. Sociodemographic characteristics and VAS scores at all time points, except for anticipated pain, were similar between groups. The median pain score with dilator placement was 48 mm in the gel group and 61 mm in the PCB group (p=.23). Procedure times for the gel group and PCB group were 3.7 min and 5.2 min, respectively (p<.01). Lidocaine gel was noninferior to PCB for reported pain scores (VAS) with dilator placement, with a difference in means of -8 mm (95% CI -21, 5) favoring the gel.
CONCLUSIONS


Self-administration of lidocaine gel prior to placement of cervical dilators for D&E is noninferior to paracervical lidocaine block for local anesthesia and is a potential alternative to PCB for pain management with osmotic dilator placement.
IMPLICATIONS


Lidocaine gel and similar products represent noninvasive, nonpainful methods of local anesthesia for a variety of outpatient gynecologic procedures. Given our noninferiority findings, if gel anesthetics are available, they should be considered as an alternative to paracervical block.",2019,The median pain score with dilator placement was 48 mm in the gel group and 61 mm in the PCB group (p=.23).,"['local anesthesia prior to osmotic dilator placement', 'enrolled 72 women and analyzed data for 69 participants', ""women ≥18\u202fyears of age undergoing surgical abortion at ≥16\u202fweeks' gestation in two outpatient clinics""]","['cervical dilator placement prior to dilation and evacuation (D&E) with patient-administered vaginal lidocaine gel versus lidocaine paracervical block (PCB', 'lidocaine gel', 'lidocaine gel 2% 20\u202fmL intravaginally 15-30\u202fmin before procedure initiation or lidocaine 1% 12\u202fmL PCB immediately prior to dilator placement', 'Lidocaine gel']","['median pain score with dilator placement', 'Sociodemographic characteristics and VAS scores', 'pain scores (VAS', 'pain scores', 'pain at various time points using a visual analog scale (VAS), including anticipated and baseline pain, speculum insertion, tenaculum placement, cervical dilator placement (primary outcome) and speculum removal']","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C0180433', 'cui_str': 'Cervical dilator'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0030401', 'cui_str': 'Paracervical Block'}, {'cui': 'C0032447', 'cui_str': 'PCBs'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0585032', 'cui_str': 'Before procedure (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0180964', 'cui_str': 'Tenaculum'}, {'cui': 'C0180433', 'cui_str': 'Cervical dilator'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",72.0,0.232716,The median pain score with dilator placement was 48 mm in the gel group and 61 mm in the PCB group (p=.23).,"[{'ForeName': 'Gillian B', 'Initials': 'GB', 'LastName': 'Schivone', 'Affiliation': 'Stanford University, Department of Obstetrics and Gynecology, Division of Family Planning Services and Research, 300 Pasteur Drive, HG 332, Palo Alto, CA, USA 94305. Electronic address: gschivone@wustl.edu.'}, {'ForeName': 'Klaira', 'Initials': 'K', 'LastName': 'Lerma', 'Affiliation': 'Stanford University, Department of Obstetrics and Gynecology, Division of Family Planning Services and Research, 300 Pasteur Drive, HG 332, Palo Alto, CA, USA 94305. Electronic address: klerma@stanford.edu.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Montgomery', 'Affiliation': 'Stanford University, Department of Obstetrics and Gynecology, Division of Family Planning Services and Research, 300 Pasteur Drive, HG 332, Palo Alto, CA, USA 94305. Electronic address: corinnemontgomery@stanford.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wright', 'Affiliation': 'Stanford University, Department of Obstetrics and Gynecology, Division of Family Planning Services and Research, 300 Pasteur Drive, HG 332, Palo Alto, CA, USA 94305. Electronic address: jacquelinebarbic@gmail.com.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Conti', 'Affiliation': 'Stanford University, Department of Obstetrics and Gynecology, Division of Family Planning Services and Research, 300 Pasteur Drive, HG 332, Palo Alto, CA, USA 94305. Electronic address: jconti@stanford.edu.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Blumenthal', 'Affiliation': 'Stanford University, Department of Obstetrics and Gynecology, Division of Family Planning Services and Research, 300 Pasteur Drive, HG 332, Palo Alto, CA, USA 94305. Electronic address: pblumen@stanford.edu.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Shaw', 'Affiliation': 'Stanford University, Department of Obstetrics and Gynecology, Division of Family Planning Services and Research, 300 Pasteur Drive, HG 332, Palo Alto, CA, USA 94305. Electronic address: kateshaw@stanford.edu.'}]",Contraception,['10.1016/j.contraception.2018.11.013']
1755,30417697,A Prospective Evaluation of the Effect of Supervised Hand Therapy After Carpal Tunnel Surgery.,"Background:  The objective of this investigation is to examine the effect of postoperative therapy after routine carpal tunnel release. Our hypothesis was that supervised hand therapy does not improve outcomes after routine carpal tunnel release.  Methods : Patients with carpal tunnel syndrome were randomly assigned to one of 3 groups based on the last digit of their medical record numbers to one of 3 groups: standard 6-week postoperative rehabilitation (standard therapy), expedited one-session postoperative rehabilitation group (expedited therapy), and no postoperative rehabilitation group (no therapy). The primary outcome measures were Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) and return to work. The outcome questionnaire was completed preoperatively, at the 2-week follow-up visit, and monthly to 6 months after surgery.  Results:  All 3 treatment groups had similar mean QuickDASH scores preoperatively. At 1- to 6-month follow-up, all 3 groups had similar QuickDASH scores at each visit, and all showed a significant decline from baseline (preoperative) QuickDASH score. Overall, QuickDASH score decreased significantly from a preoperative visit mean of 42.7 to a final postoperative (visit 8) mean of 6.69. There was no significant difference in the mean QuickDASH score among all 3 groups at 6-month follow-up. There was no significance in the time of return to work among the 3 groups (standard therapy, 21.8 days; expedited therapy, 20.9 days; no therapy, 16.6 days).  Conclusions : This investigation adds evidence that supervised hand therapy does not improve the outcomes of routine carpal tunnel surgery as measured by QuickDASH and return to work.",2020,There was no significant difference in the mean QuickDASH score among all 3 groups at 6-month follow-up.,['Patients with carpal tunnel syndrome'],"['standard 6-week postoperative rehabilitation (standard therapy), expedited one-session postoperative rehabilitation group (expedited therapy), and no postoperative rehabilitation group (no therapy', 'Supervised Hand Therapy']","['mean QuickDASH scores', 'mean QuickDASH score', 'QuickDASH scores', 'Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) and return to work', 'time of return to work', 'Overall, QuickDASH score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0291675,There was no significant difference in the mean QuickDASH score among all 3 groups at 6-month follow-up.,"[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Gil', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Barrett', 'Initials': 'B', 'LastName': 'Weiss', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Kleiner', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Akelman', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Arnold-Peter C', 'Initials': 'AC', 'LastName': 'Weiss', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]","Hand (New York, N.Y.)",['10.1177/1558944718812155']
1756,30381901,High protein diet promotes body weight loss among Brazilian postpartum women.,"There is evidence in the general population that adhering to a high protein and low carbohydrate diet may help in losing weight. However, there is little evidence among postpartum women. The aim of this study is to evaluate the effect of a high protein diet on weight loss among postpartum women. A parallel-randomized controlled trial with 94 postpartum women was conducted in a maternity ward in Mesquita county (recruitment from February 2009 to December 2010) and in a polyclinic in Rio de Janeiro city (recruitment from December 2010 to December 2011). Women were randomized to the intervention group (IG) or control group (CG), and both groups received an isocaloric diet (1,800 kcal). Additionally, the IG received approximately 25 g of protein obtained from 125 g per week of sardine to increase daily dietary protein content and was advised to restrict carbohydrate intake. The CG received nutritional counselling to follow the national nutrition guidelines (15% protein, 60% carbohydrates, and 25% lipids). A linear mixed-effects model was used to test the effect of high protein intake and macronutrient intake on weight loss during the postpartum period. Body weight decreased in the IG compared with the CG (ß = -0.325; p = 0.049) among overweight and obese postpartum women. The percentage of energy intake from lipid (ß = -0.023; p = 0.050) was negatively associated with body weight, and carbohydrate intake (ß = 0.020; p = 0.026) was positively associated with body weight over time among all women. Protein intake and lower carbohydrate intake may be used as a dietary strategy to improve body weight loss during the postpartum period.",2019,"The percentage of energy intake from lipid (ß = -0.023; p = 0.050) was negatively associated with body weight, and carbohydrate intake (","['Brazilian postpartum women', 'postpartum women', '94 postpartum women was conducted in a maternity ward in Mesquita county (recruitment from February 2009 to December 2010) and in a polyclinic in Rio de Janeiro city (recruitment from December 2010 to December 2011']","['intervention group (IG) or control group (CG', 'High protein diet', 'high protein diet', 'isocaloric diet', 'CG (ß', 'high protein intake and macronutrient intake']","['body weight, and carbohydrate intake ', 'weight loss', 'percentage of energy intake from lipid', 'Body weight', 'body weight loss', 'body weight']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0445581', 'cui_str': 'Rio (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0425403', 'cui_str': 'Diet, High-Protein'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",94.0,0.0281551,"The percentage of energy intake from lipid (ß = -0.023; p = 0.050) was negatively associated with body weight, and carbohydrate intake (","[{'ForeName': 'Maria Beatriz Trindade', 'Initials': 'MBT', 'LastName': 'de Castro', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josue de Castro (INJC), Federal University of Rio de Janeiro, Graduate Program of Nutrition/INJC, Rio de Janeiro, Brazil.'}, {'ForeName': 'Diana Barbosa', 'Initials': 'DB', 'LastName': 'Cunha', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Marina Campos', 'Initials': 'MC', 'LastName': 'Araujo', 'Affiliation': 'Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation/Ministry of Health, Rio de Janeiro, Brazil.'}, {'ForeName': 'Ilana Nogueira', 'Initials': 'IN', 'LastName': 'Bezerra', 'Affiliation': 'Mater in Nutrition and Health Course, Ceará State University, Fortaleza, Brazil.'}, {'ForeName': 'Amanda Rodrigues Amorim', 'Initials': 'ARA', 'LastName': 'Adegboye', 'Affiliation': 'Department of Psychology, Social Work and Counselling, Faculty of Education and Health, University of Greenwich, London, UK.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Kac', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josue de Castro (INJC), Federal University of Rio de Janeiro, Graduate Program of Nutrition/INJC, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rosely', 'Initials': 'R', 'LastName': 'Sichieri', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}]",Maternal & child nutrition,['10.1111/mcn.12746']
1757,31863269,The benefits of expressive writing among newly diagnosed mainland Chinese breast cancer patients.,"The study aimed to evaluate the effects of an expressive writing intervention on quality of life (QoL) among mainland Chinese breast cancer patients. A total of 118 Chinese breast cancer patients were randomly assigned to one of four groups: a cancer-facts writing condition (CTL group), an emotional disclosure writing condition (EMO group), a self-regulation writing condition (SR group), or a neutral control condition with no writing tasks (CON group). QoL was assessed by FACT-B at baseline, 3-, and 6-month follow-ups. A repeated measure analysis of variance revealed significant effects of time (F = 13.9, P < 0.001, η 2  = 0.20) and the time × group interaction (F = 3.5, P < 0.01, η 2  = 0.08) on QoL. Residualized change models showed that the CTL, EMO and SR groups reported higher levels of QoL than the CON group at the 6-month follow-up. The EMO group had a higher level of QoL than the SR group. The CTL group had higher level of physical well-being compared to the SR group. Mainland Chinese breast cancer patients shortly after diagnosis benefit from expressive writing. They benefited more from cancer-facts and emotional disclosure compared to self-regulation. The study indicated that the impact of expressive writing may differ due to stage of cancer survivorship, social, and cultural context.",2020,"A repeated measure analysis of variance revealed significant effects of time (F = 13.9, P < 0.001, η 2  = 0.20) and the time × group interaction (F = 3.5, P < 0.01, η 2  = 0.08) on QoL. Residualized change models showed that the CTL, EMO and SR groups reported higher levels of QoL than the CON group at the 6-month follow-up.","['118 Chinese breast cancer patients', 'newly diagnosed mainland Chinese breast cancer patients', 'Mainland Chinese breast cancer patients shortly after diagnosis benefit from expressive writing', 'mainland Chinese breast cancer patients']","['EMO', 'expressive writing intervention', 'cancer-facts writing condition (CTL group), an emotional disclosure writing condition (EMO group), a self-regulation writing condition (SR group), or a neutral control condition with no writing tasks (CON group', 'expressive writing', 'CTL', 'CON']","['levels of QoL', 'quality of life (QoL', 'level of QoL']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034380'}]",118.0,0.0274405,"A repeated measure analysis of variance revealed significant effects of time (F = 13.9, P < 0.001, η 2  = 0.20) and the time × group interaction (F = 3.5, P < 0.01, η 2  = 0.08) on QoL. Residualized change models showed that the CTL, EMO and SR groups reported higher levels of QoL than the CON group at the 6-month follow-up.","[{'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Ji', 'Affiliation': 'Department of Medical Nursing, Weifang Medical University, Wei Fang, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Psychology, University of Houston, Houston, USA. qlu@mdanderson.org.'}, {'ForeName': 'Li-Juan', 'Initials': 'LJ', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Weifang People's Hospital, Wei Fang, China.""}, {'ForeName': 'Xiang-Lian', 'Initials': 'XL', 'LastName': 'Sun', 'Affiliation': ""Department of Breast Surgery, Weifang People's Hospital, Wei Fang, China.""}, {'ForeName': 'Hui-Dong', 'Initials': 'HD', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Weifang People's Hospital, Wei Fang, China.""}, {'ForeName': 'Bing-Xue', 'Initials': 'BX', 'LastName': 'Han', 'Affiliation': 'Department of Psychology, Weifang Medical University, Wei Fang, China.'}, {'ForeName': 'Yu-Feng', 'Initials': 'YF', 'LastName': 'Ma', 'Affiliation': 'Department of Psychology, Weifang Medical University, Wei Fang, China.'}, {'ForeName': 'Guo-Hua', 'Initials': 'GH', 'LastName': 'Lu', 'Affiliation': 'Department of Psychology, Weifang Medical University, Wei Fang, China. ghluu1@163.com.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00127-z']
1758,30383458,The Effects of a Serious Game on Depressive Symptoms and Anxiety in Breast Cancer Patients with Depression: A Pilot Study Using Functional Magnetic Resonance Imaging.,"Objective:  Depression is common in cancer patients. We investigated the effects of playing a serious game in breast cancer patients with mild to moderate depression using functional neuroimaging.  Materials and Methods:  Thirty-five participants were randomly assigned to the Game group and the Nongame group, and fifteen participants in each group completed the study protocol. Participants in the Game group were asked to play a serious game, ""Hit the Cancer"" (RAW HAND, Seoul, Korea), for at least 30 minutes/day, 5 days/week, for 3 weeks. Participants in the Nongame group received usual care. At baseline and follow-up, all participants were assessed with the Beck Depression Inventory (BDI), Beck Anxiety Inventory, Stress Response Inventory (SRI), and 3-Tesla resting-state functional magnetic resonance imaging. Changes in functional connectivity (FC) between the brain regions in the default mode network (DMN) and salience network (SN) were analyzed.  Results:  After the intervention, BDI and SRI scores in the Game group greatly decreased compared with those in the Nongame group. In addition, compared with the Nongame group, the Game group showed decreased postintervention FC between the right posterior cingulate cortex (PCC) of the DMN and right insula of the SN. The improvement in BDI and SRI scores correlated with the decrease in FC between the right PCC and right insula.  Conclusion:  Selective attention training and repetitive stimulation of the insula by serious game play might cause normalization of the FC between the SN and DMN, thus improving depressive mood.",2018,"After the intervention, BDI and SRI scores in the Game group greatly decreased compared with those in the Nongame group.","['Breast Cancer Patients with Depression', 'breast cancer patients with mild to moderate depression using functional neuroimaging', 'cancer patients', 'Thirty-five participants were randomly assigned to the Game group and the Nongame group, and fifteen participants in each group completed the study protocol']","['Functional Magnetic Resonance Imaging', 'Serious Game', 'usual care']","['postintervention FC', 'BDI and SRI scores', 'functional connectivity (FC', 'Beck Depression Inventory (BDI), Beck Anxiety Inventory, Stress Response Inventory (SRI), and 3-Tesla resting-state functional magnetic resonance imaging', 'Depressive Symptoms and Anxiety']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C3178877', 'cui_str': 'Functional Neuroimaging'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",35.0,0.049148,"After the intervention, BDI and SRI scores in the Game group greatly decreased compared with those in the Nongame group.","[{'ForeName': 'Sun Mi', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hee-Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Division of Hemato-oncology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyun Chan', 'Initials': 'HC', 'LastName': 'Hwang', 'Affiliation': 'Department of Psychiatry, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Hong', 'Affiliation': 'Department of Psychiatry, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sujin', 'Initials': 'S', 'LastName': 'Bae', 'Affiliation': 'Department of Psychiatry, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyoung Joon', 'Initials': 'KJ', 'LastName': 'Min', 'Affiliation': 'Department of Psychiatry, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Doug Hyun', 'Initials': 'DH', 'LastName': 'Han', 'Affiliation': 'Department of Psychiatry, Chung-Ang University College of Medicine, Seoul, Korea.'}]",Games for health journal,['10.1089/g4h.2017.0183']
1759,30770307,Adding Oral Pioglitazone to Standard Induction Chemotherapy of Acute Myeloid Leukemia: A Randomized Clinical Trial.,"BACKGROUND


The hypothesis of an effect by thiazolidinedione on leukemia cells was proposed 2 decades ago, but there is little clinical evidence regarding its efficacy. We evaluated the safety and efficacy of adding pioglitazone to standard induction chemotherapy in patients with acute myeloid leukemia (AML).
PATIENTS AND METHODS


In this randomized clinical trial, newly diagnosed AML patients were randomized to 1 of 2 groups. Patients in both groups received cytarabine (100 mg/m 2  per day for 7 days) and daunorubicin (60 mg/m 2  per day for 3 days). Patients in the pioglitazone group additionally received oral pioglitazone (45 mg per day). The 2 groups were compared according to remission rate, laboratory findings, and adverse events during treatment.
RESULTS


Forty patients were evaluated, 20 patients in each group. The complete remission rate was 20% more in the pioglitazone group compared to the control group (P = .202). Complications due to pioglitazone discontinuation were observed in 2 cases. The mean serum alanine aminotransferase in the fourth treatment week was significantly more in pioglitazone group compared to the control group (65.5 vs. 33.6 mg/dL, P = .039). The mean serum creatinine in all treatment phases was significantly higher in the pioglitazone group compared to the control group (P < .05). There were no significant differences between the 2 groups regarding other laboratory findings (P > .05).
CONCLUSION


Adding pioglitazone to cytarabine and daunorubicin increased the remission rate in AML patients compared to control subjects. Although this difference in remission rate between the 2 groups was not statistically significant, it could be important in the clinical setting. Pioglitazone may provide benefits as an adjuvant therapy for AML patients without causing serious adverse events.",2019,"The mean serum alanine aminotransferase in the fourth treatment week was significantly more in pioglitazone group compared to the control group (65.5 vs. 33.6 mg/dL, P = .039).","['newly diagnosed AML patients', 'Acute Myeloid Leukemia', 'Forty patients were evaluated, 20 patients in each group', 'patients with acute myeloid leukemia (AML']","['cytarabine', 'thiazolidinedione', 'oral pioglitazone', 'Pioglitazone', 'daunorubicin', 'standard induction chemotherapy', 'Oral Pioglitazone', 'pioglitazone', 'cytarabine and daunorubicin']","['complete remission rate', 'safety and efficacy', 'remission rate', 'remission rate, laboratory findings, and adverse events', 'mean serum creatinine', 'mean serum alanine aminotransferase']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}]",40.0,0.0818611,"The mean serum alanine aminotransferase in the fourth treatment week was significantly more in pioglitazone group compared to the control group (65.5 vs. 33.6 mg/dL, P = .039).","[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Ghadiany', 'Affiliation': 'Department of Hematology and Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Tabarraee', 'Affiliation': 'Department of Hematology and Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Salari', 'Affiliation': 'Department of Hematology and Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Haghighi', 'Affiliation': 'Department of Hematology and Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rezvani', 'Affiliation': 'Department of Hematology and Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyedeh Najmeh', 'Initials': 'SN', 'LastName': 'Ghasemi', 'Affiliation': 'Department of Hematology and Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: dr.nghasemi@yahoo.com.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Karimi-Sari', 'Affiliation': 'Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2019.01.006']
1760,30229989,Prevalence and Impact of De Novo Donor-Specific Antibodies During a Multicenter Immunosuppression Withdrawal Trial in Adult Liver Transplant Recipients.,"The development of human leukocyte antigen (HLA) donor-specific antibody/antibodies (DSA) is not well described in liver transplant (LT) patients undergoing immunosuppression (IS) withdrawal protocols despite the allograft risk associated with de novo DSA (dnDSA). We analyzed the development of dnDSA in 69 LT patients who received calcineurin inhibitor monotherapy and were enrolled in the ITN030ST study. Of these 69 patients, 40 stable patients were randomized to IS maintenance (n = 9) or IS minimization (n = 31). Nine of the 31 IS minimization patients achieved complete withdrawal and were free of IS. Among patients who achieved stable IS monotherapy 1 year after transplantation, the prevalence of dnDSA was 18.8%. Acute rejections and the biopsy-proven findings disqualifying patients from IS withdrawal attempt were factors associated with dnDSA development (P = 0.011 and P = 0.041, respectively). Among randomized patients, dnDSA prevalence was 51.7% after IS minimization and 66.7% in IS-free patients. dnDSA prevalence in patients on IS maintenance was 44.4%. dnDSA development during IS minimization was a risk factor for acute rejection (P = 0.015). The majority of dnDSA were against HLA-DQ antigens (78.7%). Conclusion. During the first year following transplantation, acute rejections increase the risk of developing dnDSA, so dnDSA positivity should be considered for IS withdrawal eligibility; during IS minimization, dnDSA development was associated with acute rejection, which prevented further IS withdrawal attempts.",2019,dnDSA development during IS minimization was a risk factor for acute rejection (P = 0.015).,"['Adult Liver Transplant Recipients', 'patients on', '69 LT patients who received', 'liver transplant (LT) patients undergoing immunosuppression (IS) withdrawal protocols despite the allograft risk associated with de novo DSA (dnDSA', '69 patients, 40 stable patients']",['calcineurin inhibitor monotherapy'],"['dnDSA prevalence', 'complete withdrawal', 'Prevalence and Impact of De Novo Donor-Specific Antibodies', 'Acute rejections']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3811922', 'cui_str': 'Transplanted liver present (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}]",69.0,0.0330249,dnDSA development during IS minimization was a risk factor for acute rejection (P = 0.015).,"[{'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Jucaud', 'Affiliation': 'Terasaki Research Institute, Los Angeles, CA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Shaked', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'DesMarais', 'Affiliation': 'Immune Tolerance Network, San Francisco, CA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sayre', 'Affiliation': 'Immune Tolerance Network, San Francisco, CA.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Levitsky', 'Affiliation': 'Northwestern University, Chicago, IL.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Everly', 'Affiliation': 'Terasaki Research Institute, Los Angeles, CA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30281']
1761,31888977,Using Bluetooth beacon technology to reduce distracted pedestrian behaviour: a cross-over trial study protocol.,"OBJECTIVE


Over 6400 American pedestrians die annually, a figure that is currently increasing. One hypothesised reason for the increasing trend is the role of mobile technology in distracting both pedestrians and drivers. Scientists and policy-makers have attended somewhat to distracted driving, but attention to distracted pedestrian behaviour has lagged. We will evaluate Bluetooth beacon technology as a means to alert and warn pedestrians when they approach intersections, reminding them to attend to the traffic environment and cross streets safely.
METHODS


Bluetooth beacons are small devices that broadcast information unidirectionally within a closed proximal network. We will place beacons at an intersection frequently trafficked by urban college students. From there, the beacons will transmit to an app installed on users' smartphones, signalling users to attend to their environment and cross the street safely. A cross-over trial will evaluate the app with 411 adults who frequently cross the target intersection on an urban university campus. We will monitor those participants' behaviour over three distinct time periods: (1) 3 weeks without the app being activated, (2) 3 weeks with the app activated and (3) 4 weeks without the app activated to assess retention of behaviour. Throughout the 10-week period, we will gather information to evaluate whether the intervention changes distracted pedestrian behaviour using a logistic regression to estimate the likelihood of key behavioural outcome measures and adjusting for any residual confounding. We also will test for changes in perceived risk. The trial will follow CONSORT (Consolidated Standards of Reporting Trials) statement guidelines, as modified for cross-over design studies.
CONCLUSION


If this program proves successful, it offers exciting implications for future testing and ultimately for broad distribution to reduce distracted pedestrian behavior. We discuss issues of feasibility, acceptability and scalability.",2020,A cross-over trial will evaluate the app with 411 adults who frequently cross the target intersection on an urban university campus.,"['urban college students', '411 adults who frequently cross the target intersection on an urban university campus']",['Bluetooth beacon technology'],[],"[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}]",[],411.0,0.0541355,A cross-over trial will evaluate the app with 411 adults who frequently cross the target intersection on an urban university campus.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Schwebel', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, Alabama, USA schwebel@uab.edu.'}, {'ForeName': 'Ragib', 'Initials': 'R', 'LastName': 'Hasan', 'Affiliation': 'Department of Computer Science, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Griffin', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2019-043436']
1762,30719933,Effect of fluoride dentifrices on white spot lesions during orthodontic treatment:  A randomized trial .,"OBJECTIVES


To determine the effect of Clinpro 5000, Clinpro Tooth Crème, and MI-Paste Plus on the formation of white spot lesions in patients undergoing orthodontic treatment.
MATERIALS AND METHODS


Three prospective groups with 40 patients undergoing orthodontic treatment in each group were evaluated (total recruitment = 120 subjects). The selected product was brushed on for 2 minutes twice daily for 4 months. Subjects were reviewed for 4 months on a monthly basis. The Enamel Decalcification Index (EDI) was used to determine the number of white spot lesions per surface at each visit.
RESULTS


100 subjects (35 using Clinpro 5000, 32 using Clinpro Tooth Crème, and 33 using MI Paste Plus) completed the study. The data lend strong support for Clinpro 5000 providing superior protection against enamel decalcification when compared to Clinpro Crème, and mixed support when compared to MI Paste Plus.
CONCLUSIONS


The use of Clinpro 5000, Clinpro Crème, and MI paste Plus all have a reduction effect on white spot lesions when compared to studies reported previously. Clinpro 5000 has a marginally better effect than the two other test pastes. The results of this study can be used by clinicians when deciding the effectiveness of using fluoride dentifrice products to prevent white spot lesions in their orthodontic practice (ClinicalTrials.gov ID: NCT03440996).",2019,"The data lend strong support for Clinpro 5000 providing superior protection against enamel decalcification when compared to Clinpro Crème, and mixed support when compared to MI Paste","['patients undergoing orthodontic treatment', '100 subjects (35 using Clinpro 5000, 32 using Clinpro Tooth Crème, and 33 using MI Paste', 'white spot lesions during orthodontic treatment', '40 patients undergoing orthodontic treatment in each group were evaluated (total recruitment = 120 subjects']","['Clinpro 5000, Clinpro Crème, and MI paste', 'fluoride dentifrice products', 'fluoride dentifrices', 'Clinpro 5000, Clinpro Tooth Crème, and MI-Paste', 'MI Paste']","['Enamel Decalcification Index (EDI', 'white spot lesions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2927681', 'cui_str': 'Clinpro 5000'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spot'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C2927681', 'cui_str': 'Clinpro 5000'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0700185', 'cui_str': 'Demineralized structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spot'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",40.0,0.0339955,"The data lend strong support for Clinpro 5000 providing superior protection against enamel decalcification when compared to Clinpro Crème, and mixed support when compared to MI Paste","[{'ForeName': 'Chung H', 'Initials': 'CH', 'LastName': 'Kau', 'Affiliation': ''}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Palombini', 'Affiliation': ''}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Abou-Kheir', 'Affiliation': ''}, {'ForeName': 'Terpsithea', 'Initials': 'T', 'LastName': 'Christou', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/051818-371.1']
1763,30719926,"Exploring the Effects of Clinical Exam Room Design on Communication, Technology Interaction, and Satisfaction.","OBJECTIVE


This article evaluates the effects of technology integration and design features in clinical exam rooms on examination experiences, communication, and satisfaction.
BACKGROUND


Exam room features can affect the delivery of patient-centered care and enhance the level of communication, which has been shown to directly impact clinical outcomes. Although there has been an increasing body of literature examining design and patient-centered care, little research has evaluated the extent to which information sharing and electronic health record (EHR) interaction are impacted.
METHOD


The research randomly allocated 22 patients, 28 caregivers, and 59 clinicians to simulated clinical encounters in four exam room mock-ups with semi-inclusive, exclusive, and inclusive layouts (128 sessions in 32 scenarios). Video recordings of the simulations were coded for clinician gazing, talking, and EHR-interaction behaviors. Participants also completed surveys and answered open-ended questions after experiencing each scenario ( N  = 362).
RESULTS


Semi-inclusive rooms with a triangular arrangement of consultation table, sharable screens, exam table, and caregiver chair were highly preferred as they supported conversation, gazing, and information sharing. The  inclusive  layout had higher durations of EHR interactions and enhanced viewing and sharing of EHR information. However, this layout was criticized for the lack of clinician-shared information. The  exclusive  layouts impeded information sharing, eye contact, and constrained simultaneous data entry and eye contact for clinicians. The distance and orientation between chair, exam table, curtain, and door were important for protecting patient and family comfort and privacy.
CONCLUSION


Characteristics and configurations of design qualities and strategies have a key role on examination experiences, communication, and satisfaction.",2019,The inclusive layout had higher durations of EHR interactions and enhanced viewing and sharing of EHR information.,"['22 patients, 28 caregivers, and 59 clinicians to simulated clinical encounters in four exam room mock-ups with semi-inclusive, exclusive, and inclusive layouts (128 sessions in 32 scenarios', 'Participants also completed surveys and answered open-ended questions after experiencing each scenario ( N = 362']",[],"['Communication, Technology Interaction, and Satisfaction', 'durations of EHR interactions and enhanced viewing and sharing of EHR information']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0562577', 'cui_str': 'Mocking (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]",[],"[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",22.0,0.0311014,The inclusive layout had higher durations of EHR interactions and enhanced viewing and sharing of EHR information.,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Zamani', 'Affiliation': 'Design Researcher, EwingCole, Raleigh, NC, USA.'}, {'ForeName': 'Esperanza C', 'Initials': 'EC', 'LastName': 'Harper', 'Affiliation': 'Six Sigma Green Belt, Healthcare Planner, EwingCole, Raleigh, NC, USA.'}]",HERD,['10.1177/1937586719826055']
1764,24637543,Impact of randomized antiretroviral therapy initiation on glucose metabolism.,"OBJECTIVE


Prior studies have found that early HIV protease inhibitors contribute to glucose dysregulation. Few randomized trials have evaluated glucose indices in antiretroviral-naive individuals on newer antiretroviral therapy (ART).
METHODS


A5224s was a substudy of A5202, a prospective trial of 1857 ART-naive participants randomized to blinded abacavir-lamivudine (ABC/3TC) or tenofovir DF-emtricitabine (TDF/FTC) with open-label efavirenz (EFV) or atazanavir-ritonavir (ATV/r). Analyses used two-sample t-tests, Spearman correlation coefficients and linear regression.
RESULTS


A5224s included 269 nondiabetic individuals: 85% men, 47% white non-Hispanic, baseline median age 38 years, HIV-1 RNA 4.6 log10 copies/ml and CD4 cell count 233 cells/μl. Overall, significant 96-week increases occurred in fasting glucose, insulin and the homeostatic model assessment of insulin resistance (HOMA-IR), P ≤ 0.004. Assignment to EFV (versus ATV/r) resulted in significantly greater glucose increase [mean difference 4.4; 95% confidence interval (CI) 1.3, 7.5 mg/dl; P = 0.006] but not insulin or HOMA-IR (P ≥ 0.72). Glucose indices were not significantly different between ABC/3TC and TDF/FTC arms, P ≥ 0.18. Significant correlations were detected between changes in glucose indices and changes in BMI; all r ≥ 0.23, P ≤ 0.001. In multivariable analyses, in addition to the EFV effect, higher baseline HIV-1 RNA and greater BMI change were significant independent factors associated with greater glucose increase.
CONCLUSION


Changes in glucose metabolism were not significantly different between TDF/FTC and ABC/3TC-based regimens. A small but significantly greater increase in glucose was observed in those assigned to EFV. As glucose dysregulation may increase with time on ART, longer term studies will be needed to further clarify the clinical significance of these findings.",2014,"Glucose indices were not significantly different between ABC/3TC and TDF/FTC arms, P ≥ 0.18.","['antiretroviral-naive individuals on newer antiretroviral therapy (ART', 'A5224s included 269 nondiabetic individuals: 85% men, 47% white non-Hispanic, baseline median age 38 years, HIV-1', '1857 ART-naive participants randomized to']",['blinded abacavir-lamivudine (ABC/3TC) or tenofovir DF-emtricitabine (TDF/FTC) with open-label efavirenz (EFV) or atazanavir-ritonavir (ATV/r'],"['glucose indices and changes in BMI', 'EFV effect, higher baseline HIV-1 RNA and greater BMI change', 'fasting glucose, insulin and the homeostatic model assessment of insulin resistance (HOMA-IR', 'glucose metabolism', 'glucose', 'Glucose indices', 'insulin or HOMA-IR (P']","[{'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}]","[{'cui': 'C1613391', 'cui_str': 'abacavir / Lamivudine'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",1857.0,0.153461,"Glucose indices were not significantly different between ABC/3TC and TDF/FTC arms, P ≥ 0.18.","[{'ForeName': 'Kristine Mace', 'Initials': 'KM', 'LastName': 'Erlandson', 'Affiliation': ""aUniversity of Colorado-Anschutz Medical Campus, Aurora, Colorado bHarvard School of Public Health cBrigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts dLos Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance eGilead Sciences, Foster City, California fViiV Healthcare, Research Triangle, North Carolina gCase Western Reserve University, Cleveland, Ohio, USA.""}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Kitch', 'Affiliation': ''}, {'ForeName': 'Camlin', 'Initials': 'C', 'LastName': 'Tierney', 'Affiliation': ''}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ''}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Daar', 'Affiliation': ''}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Melbourne', 'Affiliation': ''}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Ha', 'Affiliation': ''}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'McComsey', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000000266']
1765,25117929,Changes in proteinuria and albuminuria with initiation of antiretroviral therapy: data from a randomized trial comparing tenofovir disoproxil fumarate/emtricitabine versus abacavir/lamivudine.,"BACKGROUND


Antiretroviral therapy (ART) is associated with improved kidney function; however, the nucleotide reverse transcriptase inhibitor (NRTI) tenofovir disoproxil fumarate (TDF) has been associated with decreased kidney function and proteinuria.
METHODS


We examined changes in urine protein:creatinine (UPCR) and urine albumin:creatinine (UACR) ratios in 245 ART-naive participants in A5202 randomized in a substudy to blinded NRTI (abacavir/lamivudine, ABC/3TC, n = 124 or TDF/emtricitabine, TDF/FTC, n = 121) with open-label protease inhibitor (PI) atazanavir/ritonavir or nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz.
RESULTS


At baseline, 18% of participants had clinically significant proteinuria (UPCR ≥200 mg/g), and 11% had clinically significant albuminuria (UACR ≥30 mg/g). The prevalence of clinically significant proteinuria and albuminuria decreased from baseline to week 96 in all treatment groups. In intention-to-treat analyses, there was a significant effect of NRTI component on fold change in UPCR (P = 0.011) and UACR (P = 0.018) from baseline to week 96, with greater improvements in participants randomized to ABC/3TC. There was no significant effect of NNRTI/PI component on fold change in UPCR (P = 0.23) or UACR (P = 0.88), and no significant interactions between NRTI and NNRTI/PI components.
CONCLUSIONS


In this prespecified secondary analysis, ART initiation was associated with improvements in proteinuria and albuminuria, with significantly greater improvements in participants randomized to ABC/3TC versus TDF/FTC. These are the first data from a randomized trial to suggest that initiation of TDF/FTC may not be associated with the same degree of improvement in proteinuria and albuminuria that have been reported with other regimens. Future studies should consider the long-term clinical significance of these findings.",2014,"There was no significant effect of NNRTI/PI component on fold change in UPCR (P = 0.23) or UACR (P = 0.88), and no significant interactions between NRTI and NNRTI/PI components.
",['245 ART-naive participants in A5202 randomized in a substudy to blinded'],"['TDF/FTC', 'NRTI (abacavir/lamivudine, ABC/3TC, n = 124 or TDF/emtricitabine, TDF/FTC, n = 121) with open-label protease inhibitor (PI) atazanavir/ritonavir or nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz', 'tenofovir disoproxil fumarate/emtricitabine versus abacavir/lamivudine', 'nucleotide reverse transcriptase inhibitor (NRTI) tenofovir disoproxil fumarate (TDF']","['NNRTI/PI component on fold change in UPCR', 'urine protein:creatinine (UPCR) and urine albumin:creatinine (UACR) ratios', 'UACR', 'proteinuria and albuminuria']","[{'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C1613391', 'cui_str': 'abacavir / Lamivudine'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1268897', 'cui_str': 'Product containing protease inhibitor'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C4521921', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0028630', 'cui_str': 'Nucleotides'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305628', 'cui_str': 'Urine protein (substance)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]",245.0,0.181713,"There was no significant effect of NNRTI/PI component on fold change in UPCR (P = 0.23) or UACR (P = 0.88), and no significant interactions between NRTI and NNRTI/PI components.
","[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Wyatt', 'Affiliation': ""*Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY; †Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, MA; ‡Department of Medicine, Indiana University School of Medicine, Indianapolis, IN; §Department of Medicine, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA; ‖Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; ¶ViiV Healthcare, Research Triangle Park, NC; #Gilead Sciences, Foster City, CA; and **Department of Pediatrics, Case Western Reserve University, Cleveland, OH.""}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Kitch', 'Affiliation': ''}, {'ForeName': 'Samir K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Camlin', 'Initials': 'C', 'LastName': 'Tierney', 'Affiliation': ''}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Daar', 'Affiliation': ''}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ''}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Ha', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Melbourne', 'Affiliation': ''}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'McComsey', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000000245']
1766,31688721,Patients are willing to wait for rapid STI results in a University Student Health clinic.,We examined the acceptability and feasibility of using a 30-minute chlamydia/gonorrhea test in a student health clinical setting. 108 students were enrolled and 89.4% were willing to wait up to 20 minutes beyond the conclusion of their routine visit. The average amount of time added per clinic visit was less than 11 minutes. Patient and staff satisfaction were high.,2019,108 students were enrolled and 89.4% were willing to wait up to 20 minutes beyond the conclusion of their routine visit.,['108 students were enrolled and 89.4% were willing to wait up to 20 minutes beyond the conclusion of their routine visit'],[],['average amount of time added per clinic visit'],"[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",,0.0232021,108 students were enrolled and 89.4% were willing to wait up to 20 minutes beyond the conclusion of their routine visit.,"[{'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Gettinger', 'Affiliation': 'University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Van Wagoner', 'Affiliation': ''}, {'ForeName': 'Brice', 'Initials': 'B', 'LastName': 'Daniels', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Boutwell', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Van Der Pol', 'Affiliation': ''}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001083']
1767,30673996,"The Effectiveness of Spiritual Therapy on Spiritual Well-Being, Self-Esteem and Self-Efficacy in Patients on Hemodialysis.","Spirituality is an important part of practice of the healthcare providers. Spiritual therapy is important for patients with chronic and end-stage diseases such as end-stage renal disease due to changes in physical, mental, social and spiritual needs. Promotion of spiritual well-being, self-esteem and self-efficacy is very important for these patients. The aim of this study was to determine the effectiveness of spiritual therapy on spiritual well-being, self-esteem and self-efficacy in patients on hemodialysis. The quasi-experimental research design was pre-posttest with the control group. The statistical population was the patients on hemodialysis in Governmental Hospital of Shahid Mostafa in Ilam, Iran, in 2015. Twenty-four patients were entered to the study by convenience sampling. They were divided into experimental and control groups randomly. Twelve 60-min sessions of spiritual therapy were held for the experimental group twice a week. The tools included spiritual well-being scale of Paloutzian and Ellison, Self Esteem Inventory of Cooper Smith and Self-Efficacy Scale of Sherer. Data were analyzed by SPSS software through descriptive and inferential statistics (analysis of covariance). p Values < 0.05 were considered significant. Results indicated that the scores in the experimental group changed in spiritual health from 39.32 ± 3.38 to 43.40 ± 2.82, in self-esteem from 42.65 ± 2.61 to 45.90 ± 3.88 and in self-efficacy from 40.99 ± 2.19 to 44.65 ± 2.58 which was significant compared with the control group (p = 0.01). Spiritual therapy can be used as an effective intervention to improve spiritual well-being, self-esteem and self-efficacy in patients on hemodialysis. This intervention is directed to holistic care. It can be done by interdisciplinary participation in caring and psychological teams.",2020,"Spiritual therapy can be used as an effective intervention to improve spiritual well-being, self-esteem and self-efficacy in patients on hemodialysis.","['patients on hemodialysis in Governmental Hospital of Shahid Mostafa in Ilam, Iran, in 2015', 'Patients on Hemodialysis', 'patients with chronic and end-stage diseases such as end-stage renal disease', 'patients on hemodialysis', 'Twenty-four patients were entered to the study by convenience sampling']","['spiritual therapy', 'Spiritual therapy', 'Spiritual Therapy']","['Spiritual Well-Being, Self-Esteem and Self-Efficacy', 'spiritual well-being scale of Paloutzian and Ellison, Self Esteem Inventory of Cooper Smith and Self-Efficacy Scale of Sherer', 'spiritual well-being, self-esteem and self-efficacy', 'spiritual health']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0679674', 'cui_str': 'Spiritual Therapies'}]","[{'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0222045'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0335912', 'cui_str': 'Cooper (occupation)'}, {'cui': 'C0554249', 'cui_str': 'Smith (occupation)'}, {'cui': 'C0686997', 'cui_str': 'Spiritual health'}]",24.0,0.0135157,"Spiritual therapy can be used as an effective intervention to improve spiritual well-being, self-esteem and self-efficacy in patients on hemodialysis.","[{'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Darvishi', 'Affiliation': 'Faculty of Humanistic, Islamic Azad University, Unit of Ilam, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Otaghi', 'Affiliation': 'Faculty of Humanistic, Islamic Azad University, Unit of Ilam, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Mami', 'Affiliation': 'Faculty of Humanistic, Islamic Azad University, Unit of Ilam, Iran. shahrammami95@yahoo.com.'}]",Journal of religion and health,['10.1007/s10943-018-00750-1']
1768,30153359,Simtuzumab for Primary Sclerosing Cholangitis: Phase 2 Study Results With Insights on the Natural History of the Disease.,"Lysyl oxidase like-2 (LOXL2) plays a central role in fibrogenesis and is elevated in the serum and liver of patients with primary sclerosing cholangitis (PSC). We evaluated the safety and efficacy of simtuzumab, a monoclonal antibody directed against LOXL2, in patients with PSC. Patients with compensated liver disease caused by PSC were randomized 1:1:1 to receive weekly subcutaneous injections of simtuzumab 75 mg, simtuzumab 125 mg, or placebo for 96 weeks. The primary efficacy endpoint was mean change in hepatic collagen content assessed by morphometry between baseline and week 96. Additional endpoints included change in Ishak fibrosis stage and the frequency of PSC-related clinical events. Overall, 234 patients were randomized and started treatment. At week 96, the mean change from baseline in hepatic collagen content was -0.5% for patients receiving simtuzumab 75 mg (P = 0.73 versus placebo), +0.5% for patients receiving simtuzumab 125 mg (P = 0.33 versus placebo), and 0.0 for patients receiving placebo. Compared with placebo, neither dose of simtuzumab led to significant reductions in Ishak fibrosis stage, progression to cirrhosis, or frequency of clinical events. Overall, 80 (34%) patients had fibrosis progression and 47 (20%) experienced PSC-related clinical events. In a multivariate model of baseline factors, PSC-related clinical events were more frequent in patients with advanced fibrosis (hazard ratio [HR], 2.03; 95% confidence interval [CI], 1.02-4.06; P = 0.045), higher alkaline phosphatase (HR per 10 U/L, 1.01; 95% CI, 1.00-1.02; P = 0.015), and higher enhanced liver fibrosis score (HR per unit, 1.26; 95% CI, 0.98-1.61; P = 0.073). Overall, rates of adverse events and laboratory abnormalities were similar between groups. Conclusion: Treatment with the LOXL2 inhibitor simtuzumab for 96 weeks did not provide clinical benefit in patients with PSC.",2019,"Compared with placebo, neither dose of simtuzumab led to significant reductions in Ishak fibrosis stage, progression to cirrhosis, or frequency of clinical events.","['234 patients', 'Patients with compensated liver disease caused by PSC', 'Primary Sclerosing Cholangitis', 'patients with PSC', 'patients with primary sclerosing cholangitis (PSC']","['Lysyl oxidase like-2 (LOXL2', 'LOXL2 inhibitor simtuzumab', 'simtuzumab', 'Simtuzumab', 'placebo', 'simtuzumab 75 mg, simtuzumab 125 mg, or placebo']","['change in Ishak fibrosis stage and the frequency of PSC-related clinical events', 'safety and efficacy', 'hepatic collagen content', 'fibrosis progression', 'PSC-related clinical events', 'Overall, rates of adverse events and laboratory abnormalities', 'mean change in hepatic collagen content assessed by morphometry', 'higher alkaline phosphatase', 'enhanced liver fibrosis score', 'Ishak fibrosis stage, progression to cirrhosis, or frequency of clinical events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3839044', 'cui_str': 'Compensated liver disease'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis (disorder)'}]","[{'cui': 'C0024375', 'cui_str': 'Collagen Lysyl Oxidase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4054022', 'cui_str': 'simtuzumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0200760', 'cui_str': 'Morphometry'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]",234.0,0.384365,"Compared with placebo, neither dose of simtuzumab led to significant reductions in Ishak fibrosis stage, progression to cirrhosis, or frequency of clinical events.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Muir', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'University of Miami, Miami, FL.'}, {'ForeName': 'Harry L A', 'Initials': 'HLA', 'LastName': 'Janssen', 'Affiliation': 'Toronto Centre for Liver Disease, Toronto, ON, Canada.'}, {'ForeName': 'Aldo J', 'Initials': 'AJ', 'LastName': 'Montano-Loza', 'Affiliation': 'University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Mitchell L', 'Initials': 'ML', 'LastName': 'Shiffman', 'Affiliation': 'Liver Institute of Virginia, Richmond, VA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Caldwell', 'Affiliation': 'University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Velimir', 'Initials': 'V', 'LastName': 'Luketic', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'McColgan', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'McHutchison', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mani Subramanian', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Myers', 'Affiliation': 'Gilead Sciences, Inc, Foster City, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manns', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Chapman', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Nezam H', 'Initials': 'NH', 'LastName': 'Afdhal', 'Affiliation': 'Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, VA.'}, {'ForeName': 'Bertus', 'Initials': 'B', 'LastName': 'Eksteen', 'Affiliation': 'Aspen Woods Clinic, Calgary, AB, Canada.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Bowlus', 'Affiliation': 'University of California at Davis, Sacramento, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30237']
1769,30653416,Remote ischemic preconditioning increases accumulated oxygen deficit in middle-distance runners.,"The mediators underlying the putative benefits of remote ischemic preconditioning (IPC) on dynamic whole body exercise performance have not been widely investigated. Our objective was to test the hypothesis that remote IPC improves supramaximal exercise performance in National Collegiate Athletic Association (NCAA) Division I middle-distance runners by increasing accumulated oxygen deficit (AOD), an indicator of glycolytic capacity. A randomized sham-controlled crossover study was employed. Ten NCAA Division I middle-distance athletes [age: 21 ± 1 yr; maximal oxygen uptake (V̇o 2max ): 65 ± 7 ml·kg -1 ·min -1 ] completed three supramaximal running trials (baseline, after mock IPC, and with remote IPC) at 110% V̇o 2max  to exhaustion. Remote IPC was induced in the right arm with 4 × 5 min cycles of brachial artery ischemia with 5 min of reperfusion. Supramaximal AOD (ml/kg) was calculated as the difference between the theoretical oxygen demand required for the supramaximal running bout (linear regression extrapolated from ~12 × 5 min submaximal running stages) and the actual oxygen demand for these bouts. Remote IPC [122 ± 38 s, 95% confidence interval (CI): 94-150] increased ( P  < 0.001) time to exhaustion 22% compared with baseline (99 ± 23 s, 95% CI: 82-116,  P  = 0.014) and sham (101 ± 30 s, 95% CI: 80-123,  P  = 0.001). In the presence of IPC, AOD was 47 ± 36 ml/kg (95% CI: 20.8-73.9), a 29% increase compared with baseline (36 ± 28 ml/kg, 95% CI: 16.3-56.9,  P  = 0.008) and sham (38 ± 32 ml/kg, 95% CI: 16.2-63.0,  P  = 0.024). Remote IPC considerably improved supramaximal exercise performance in NCAA Division I middle-distance athletes. Greater glycolytic capacity, as estimated by increased AOD, is a potential mediator for these performance improvements.  NEW & NOTEWORTHY  Our novel findings indicate that ischemic preconditioning enhanced glycolytic exercise capacity, enabling National Collegiate Athletic Association (NCAA) middle-distance track athletes to run ~22 s longer before exhaustion compared with baseline and mock ischemic preconditioning. The increase in ""all-out"" performance appears to be due to increased accumulated oxygen deficit, an index of better supramaximal capacity. Of note, enhanced exercise performance was demonstrated in a specific group of in-competition NCAA elite athletes that has already undergone substantial training of the glycolytic energy systems.",2019,Remote IPC considerably improved supramaximal exercise performance in NCAA Division,"['National Collegiate Athletic Association (NCAA', 'middle-distance runners', 'NCAA Division', 'I middle-distance athletes', 'I middle-distance athletes [age: 21\u2009±\u20091 yr']","['maximal oxygen uptake (V̇o 2max ): 65\u2009±\u20097 ml·kg -1 ·min -1 ] completed three supramaximal running trials (baseline, after mock IPC, and with remote IPC', 'remote ischemic preconditioning (IPC', 'Remote ischemic preconditioning', 'Division']","['accumulated oxygen deficit (AOD', 'Greater glycolytic capacity', 'glycolytic exercise capacity, enabling National Collegiate Athletic Association (NCAA) middle-distance track athletes', 'supramaximal exercise performance', 'oxygen deficit']","[{'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0562577', 'cui_str': 'Mocking (finding)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",,0.563839,Remote IPC considerably improved supramaximal exercise performance in NCAA Division,"[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Paull', 'Affiliation': 'Vascular Protection Research Laboratory, Department of Health and Nutritional Sciences, South Dakota State University , Brookings, South Dakota.'}, {'ForeName': 'Gary P', 'Initials': 'GP', 'LastName': 'Van Guilder', 'Affiliation': 'Vascular Protection Research Laboratory, Department of Health and Nutritional Sciences, South Dakota State University , Brookings, South Dakota.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00585.2018']
1770,30697876,The effect of short-duration resistance training on insulin sensitivity and muscle adaptations in overweight men.,"NEW FINDINGS


What is the central question of this study? What is the time course of muscular adaptations to short-duration resistance exercise training? What is the main finding and its importance? Short-duration resistance training results in early and progressive increases in muscle mass and function and an increase in insulin sensitivity.
ABSTRACT


The aim of the study was to investigate the effects of 6 weeks of resistance exercise training, composed of one set of each exercise to voluntary failure, on insulin sensitivity and the time course of adaptations in muscle strength/mass. Ten overweight men (age 36 ± 8 years; height 175 ± 9 cm; weight 89 ± 14 kg; body mass index 29 ± 3 kg m -2  ) were recruited to the study. Resistance exercise training involved three sessions per week for 6 weeks. Each session involved one set of nine exercises, performed at 80% of one-repetition maximum to volitional failure. Sessions lasted 15-20 min. Oral glucose tolerance tests were performed at baseline and post-intervention. Vastus lateralis muscle thickness, knee-extensor maximal isometric torque and rate of torque development (measured between 0 and 50, 0 and 100, 0 and 200, and 0 and 300 ms) were measured at baseline, each week of the intervention, and after the intervention. Resistance training resulted in a 16.3 ± 18.7% (P < 0.05) increase in insulin sensitivity (Cederholm index). Muscle thickness, maximal isometric torque and one-repetition maximum increased with training, and at the end of the intervention were 10.3 ± 2.5, 26.9 ± 8.3, 18.3 ± 4.5% higher (P < 0.05 for both) than baseline, respectively. The rate of torque development at 50 and 100 ms, but not at 200 and 300 ms, increased (P < 0.05) over the intervention period. Six weeks of single-set resistance exercise to failure results in improvements in insulin sensitivity and increases in muscle size and strength in young overweight men.",2019,Six weeks of single-set resistance exercise to failure results in improvements in insulin sensitivity and increases in muscle size and strength in young overweight men.,"['Ten overweight men (age 36\xa0±\xa08 years; height 175\xa0±\xa09\xa0cm; weight 89\xa0±\xa014\xa0kg; body mass index 29\xa0±\xa03\xa0kg\xa0m -2  ', 'overweight men', 'young overweight men']","['resistance exercise training', 'short-duration resistance training', 'Resistance training', 'Resistance exercise training']","['insulin sensitivity', 'Muscle thickness, maximal isometric torque and one-repetition maximum', 'insulin sensitivity (Cederholm index', 'Oral glucose tolerance tests', 'Vastus lateralis muscle thickness, knee-extensor maximal isometric torque and rate of torque development', 'rate of torque development', 'muscle size and strength', 'insulin sensitivity and muscle adaptations']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0224444', 'cui_str': 'Vastus Lateralis'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}]",10.0,0.0304272,Six weeks of single-set resistance exercise to failure results in improvements in insulin sensitivity and increases in muscle size and strength in young overweight men.,"[{'ForeName': 'Ahmad D', 'Initials': 'AD', 'LastName': 'Ismail', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Faris F Aba', 'Initials': 'FFA', 'LastName': 'Alkhayl', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Lynsey', 'Initials': 'L', 'LastName': 'Johnston', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jason M R', 'Initials': 'JMR', 'LastName': 'Gill', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Gray', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}]",Experimental physiology,['10.1113/EP087435']
1771,30374754,Work of breathing during HHHFNC and synchronised NIPPV following extubation.,"Our aim was to compare the work of breathing (WOB) during synchronised nasal intermittent positive pressure ventilation (SNIPPV) and heated humidified high flow nasal cannula (HHHFNC) when used as post-extubation support in preterm infants. A randomised crossover study was undertaken of nine infants with a median gestational age of 27 (range 24-31) weeks and post-natal age of 7 (range 2-50) days. Infants were randomised to either SNIPPV or HHHFNC immediately following extubation. They were studied for 2 h on one mode and then switched to the other modality and studied for a further 2-h period. The work of breathing, assessed by measuring the pressure time product of the diaphragm (PTPdi), and thoracoabdominal asynchrony (TAA) were determined at the end of each 2-h period. The infants' inspired oxygen requirement, oxygen saturation, heart rate and respiratory rate were also recorded. The median PTPdi was lower on SNIPPV than on HHHFNC (232 (range 130-352) versus 365 (range 136-449) cmH 2 O s/min, p = 0.0077), and there was less thoracoabdominal asynchrony (13.4 (range 8.5-41.6) versus 36.1 (range 4.3-50.4) degrees, p = 0.038).Conclusion: In prematurely born infants, SNIPPV compared to HHHFNC post-extubation reduced the work of breathing and thoracoabdominal asynchrony. What is Known: • The work of breathing and extubation failure are not significantly different in prematurely-born infants supported by HHHFNC or nCPAP. • SNIPPV reduces inspiratory effort and increases tidal volume and carbon dioxide exchange compared to nCPAP in prematurely born infants. What is New: • SNIPPV, as compared to HHHFNC, reduced the work of breathing in prematurely-born infants studied post-extubation. • SNIPPV, as compared to HHHFNC, reduced thoracoabdominal asynchrony in prematurely born infants studied post-extubation.",2019,The work of breathing and extubation failure are not significantly different in prematurely-born infants supported by HHHFNC or nCPAP.,"['nine infants with a median gestational age of 27 (range', 'prematurely born infants', 'preterm infants']","['HHHFNC', 'SNIPPV or HHHFNC', 'synchronised nasal intermittent positive pressure ventilation (SNIPPV) and heated humidified high flow nasal cannula (HHHFNC']","['pressure time product of the diaphragm (PTPdi), and thoracoabdominal asynchrony (TAA', 'median PTPdi', 'work of breathing (WOB', 'thoracoabdominal asynchrony', 'breathing and extubation failure', 'tidal volume and carbon dioxide exchange', 'oxygen requirement, oxygen saturation, heart rate and respiratory rate']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0021778', 'cui_str': 'IPPV'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0444467', 'cui_str': 'Thoracoabdominal (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0043229', 'cui_str': 'Work of Breathing'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}]",9.0,0.0585599,The work of breathing and extubation failure are not significantly different in prematurely-born infants supported by HHHFNC or nCPAP.,"[{'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Charles', 'Affiliation': ""MRC & Asthma UK Centre for Allergic Mechanisms in Asthma, King's College London, NICU, 4th Floor Golden Jubilee Wing, King's College Hospital, Denmark Hill, London, SE5 9RS, UK. Elinor.charles@nhs.net.""}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'Hunt', 'Affiliation': ""MRC & Asthma UK Centre for Allergic Mechanisms in Asthma, King's College London, NICU, 4th Floor Golden Jubilee Wing, King's College Hospital, Denmark Hill, London, SE5 9RS, UK. Katie.a.hunt@kcl.ac.uk.""}, {'ForeName': 'Gerrard F', 'Initials': 'GF', 'LastName': 'Rafferty', 'Affiliation': ""Centre for Human and Aerospace Physiological Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Peacock', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""MRC & Asthma UK Centre for Allergic Mechanisms in Asthma, King's College London, NICU, 4th Floor Golden Jubilee Wing, King's College Hospital, Denmark Hill, London, SE5 9RS, UK. anne.greenough@kcl.ac.uk.""}]",European journal of pediatrics,['10.1007/s00431-018-3254-3']
1772,30679095,"Efficacy and safety of oral basal insulin versus subcutaneous insulin glargine in type 2 diabetes: a randomised, double-blind, phase 2 trial.","BACKGROUND


Oral insulin 338 (I338) is a long-acting, basal insulin analogue formulated in a tablet with the absorption-enhancer sodium caprate. We investigated the efficacy and safety of I338 versus subcutaneous insulin glargine (IGlar) in patients with type 2 diabetes.
METHODS


This was a phase 2, 8-week, randomised, double-blind, double-dummy, active-controlled, parallel trial completed at two research institutes in Germany. Insulin-naive adult patients with type 2 diabetes, inadequately controlled on metformin monotherapy or combined with other oral antidiabetic drugs (HbA 1c  7·0-10·0%; BMI 25·0-40·0 kg/m 2 ), were randomly assigned (1:1) to receive once-daily I338 plus subcutaneous placebo (I338 group) or once-daily IGlar plus oral placebo (IGlar group). Randomisation occurred by interactive web response system stratified by baseline treatment with oral antidiabetic drugs. Patients and investigators were masked to treatment assignment. Weekly insulin dose titration aimed to achieve a self-measured fasting plasma glucose (FPG) concentration of 4·4-7·0 mmol/L. The recommended daily starting doses were 2700 nmol I338 or 10 U IGlar, and maximum allowed doses throughout the trial were 16 200 nmol I338 or 60 U IGlar. The primary endpoint was treatment difference in FPG concentration at 8 weeks for all randomly assigned patients receiving at least one dose of trial product (ie, the full analysis set). The trial has been completed and is registered at ClinicalTrials.gov, number NCT02470039.
FINDINGS


Between June 1, 2015, and Oct 19, 2015, 82 patients were screened for eligibility and 50 patients were randomly assigned to the I338 group (n=25) or the IGlar group (n=25). Mean FPG concentration at baseline was 9·7 (SD 2·8) in the I338 group and 9·1 (1·7) in the IGlar group. Least square mean FPG concentration at 8 weeks was 7·1 mmol/L (95% CI 6·4-7·8) in the I338 group and 6·8 mmol/L (6·5-7·1) in the IGlar group, with no significant treatment difference (0·3 mmol/L [-0·5 to 1·1]; p=0·46). I338 and IGlar were well tolerated by patients. Adverse events were reported in 15 (60%) patients in the I338 group and 17 (68%) patients in the IGlar group. The most common adverse events were diarrhoea (three [12%] patients in each group) and nasopharyngitis (five [20%] in the I338 group and two [8%] in the IGlar group). Most adverse events were graded mild (47 of 68 events), and no severe adverse events were reported. One patient in the IGlar group had a treatment-emergent serious adverse event (urogenital haemorrhage of moderate intensity, assessed by the investigator as unlikely to be related to treatment; the patient recovered). Incidence of hypoglycaemia was low in both groups (n=7 events in the I338 group; n=11 in the IGlar group), with no severe episodes.
INTERPRETATION


I338 can safely improve glycaemic control in insulin-naive patients with type 2 diabetes with no evidence of a difference compared with insulin glargine, a widely used subcutaneously administered basal insulin. Further development of this particular oral insulin project was discontinued because I338 doses were high and, therefore, production of the required quantities of I338 for wide public use was deemed not commercially viable. Improvement of technologies involved in the product's development is the focus of ongoing research.
FUNDING


Novo Nordisk.",2019,The most common adverse events were diarrhoea (three [12%] patients in each group) and nasopharyngitis (five [20%] in the I338 group and two [8%] in the IGlar group).,"['type 2 diabetes', 'Insulin-naive adult patients with type 2 diabetes', 'HbA 1c  7·0-10·0%; BMI 25·0-40·0 kg/m 2 ', 'patients with type 2 diabetes', 'Between June 1, 2015, and Oct 19, 2015, 82 patients were screened for eligibility and 50 patients were randomly assigned to the I338 group (n=25) or the IGlar group (n=25']","['oral basal insulin versus subcutaneous insulin glargine', 'metformin monotherapy or combined with other oral antidiabetic drugs', 'receive once-daily I338 plus subcutaneous placebo (I338 group) or once-daily IGlar plus oral placebo (IGlar group', 'subcutaneous insulin glargine (IGlar', 'insulin glargine']","['Adverse events', 'treatment-emergent serious adverse event (urogenital haemorrhage of moderate intensity', 'nasopharyngitis', 'glycaemic control', 'fasting plasma glucose (FPG) concentration', 'Mean FPG concentration', 'diarrhoea', 'severe adverse events', 'Least square mean FPG concentration', 'Efficacy and safety', 'Incidence of hypoglycaemia', 'efficacy and safety', 'FPG concentration']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0919591', 'cui_str': 'Urogenital bleeding'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",82.0,0.341686,The most common adverse events were diarrhoea (three [12%] patients in each group) and nasopharyngitis (five [20%] in the I338 group and two [8%] in the IGlar group).,"[{'ForeName': 'Inge B', 'Initials': 'IB', 'LastName': 'Halberg', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark. Electronic address: ibh@novonordisk.com.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Lyby', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Wassermann', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil Mainz GmbH & Co KG, Mainz, Germany.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(18)30372-3']
1773,31688064,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES


To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS


This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS


Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION


Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
1774,30872116,"Loss of bronchoprotection with ICS plus LABA treatment, β-receptor dynamics, and the effect of alendronate.","BACKGROUND


Loss of bronchoprotection (LOBP) with a regularly used long-acting β 2 -adrenergic receptor agonist (LABA) is well documented. LOBP has been attributed to β 2 -adrenergic receptor (B2AR) downregulation, a process requiring farnesylation, which is inhibited by alendronate.
OBJECTIVE


We sought to determine whether alendronate can reduce LABA-associated LOBP in inhaled corticosteroid (ICS)-treated patients.
METHODS


We conducted a randomized, double-blind, placebo-controlled, parallel-design, proof-of-concept trial. Seventy-eight participants with persistent asthma receiving 250 μg of fluticasone twice daily for 2 weeks were randomized to receive alendronate or placebo while initiating salmeterol for 8 weeks. Salmeterol-protected methacholine challenges (SPMChs) and PBMC B2AR numbers (radioligand binding assay) and signaling (cyclic AMP ELISA) were assessed before randomization and after 8 weeks of ICS plus LABA treatment. LOBP was defined as a more than 1 doubling dose reduction in SPMCh PC 20  value.
RESULTS


The mean doubling dose reduction in SPMCh PC 20  value was 0.50 and 0.27 with alendronate and placebo, respectively (P = .62). Thirty-eight percent of participants receiving alendronate and 33% receiving placebo had LOBP (P = .81). The after/before ICS plus LABA treatment ratio of B2AR number was 1.0 for alendronate (P = .86) and 0.8 for placebo (P = .15; P = .31 for difference between treatments). The B2AR signaling ratio was 0.89 for alendronate (P = .43) and 1.02 for placebo (P = .84; P = .44 for difference). Changes in lung function and B2AR number and signaling were similar between those who did and did not experience LOBP.
CONCLUSION


This study did not find evidence that alendronate reduces LABA-associated LOBP, which relates to the occurrence of LOBP in only one third of participants. LOBP appears to be less common than presumed in concomitant ICS plus LABA-treated asthmatic patients. B2AR downregulation measured in PBMCs does not appear to reflect LOBP.",2019,"Changes in lung function and B2AR number and signaling were similar between those who did and did not experience LOBP.
","['Seventy-eight participants with persistent asthma receiving 250\xa0μg of', 'twice daily for 2\xa0weeks', 'inhaled corticosteroid (ICS)-treated patients']","['salmeterol', 'placebo', 'fluticasone', 'alendronate or placebo', 'LOBP', 'Salmeterol-protected methacholine', 'alendronate']","['PBMC B2AR numbers (radioligand binding assay) and signaling (cyclic AMP', 'B2AR number', 'ELISA', 'B2AR downregulation measured in PBMCs', 'lung function and B2AR number and signaling', 'B2AR signaling ratio', 'LOBP']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0600370', 'cui_str': 'Methacholine'}]","[{'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0013081', 'cui_str': 'Down-Regulation (Physiology)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",78.0,0.67113,"Changes in lung function and B2AR number and signaling were similar between those who did and did not experience LOBP.
","[{'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Cardet', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Departments of Environmental Health, Genetics & Complex Diseases, Harvard T.H. Chan School of Public Health, Boston, Mass.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Departments of Environmental Health, Genetics & Complex Diseases, Harvard T.H. Chan School of Public Health, Boston, Mass.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Gerard', 'Affiliation': ""Department of Pediatrics, Boston Children's Hospital, Boston, Mass.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'McIntire', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Homer A', 'Initials': 'HA', 'LastName': 'Boushey', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Department of Medicine, Washington University, St Louis, Mo.'}, {'ForeName': 'Vernon M', 'Initials': 'VM', 'LastName': 'Chinchilli', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pa.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Codispoti', 'Affiliation': 'Department of Medicine, Rush University Medical Center and Department of Pediatrics, Stroger Hospital of Cook County, Chicago, Ill.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Dyer', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pa.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Holguin', 'Affiliation': 'Department of Medicine, Pittsburgh University, Pittsburgh, Pa.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': 'Department of Medicine, University of Arizona, Tucson, Ariz.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lazarus', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Lemanske', 'Affiliation': 'Departments of Medicine and Pharmacy Practice, University of Wisconsin, Madison, Wis.'}, {'ForeName': 'Njira', 'Initials': 'N', 'LastName': 'Lugogo', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Mauger', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pa.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Moore', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moy', 'Affiliation': 'Department of Medicine, Rush University Medical Center and Department of Pediatrics, Stroger Hospital of Cook County, Chicago, Ill.'}, {'ForeName': 'Victor E', 'Initials': 'VE', 'LastName': 'Ortega', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Peters', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Ill.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Solway', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Ill.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Sorkness', 'Affiliation': 'Departments of Medicine and Pharmacy Practice, University of Wisconsin, Madison, Wis.'}, {'ForeName': 'Kaharu', 'Initials': 'K', 'LastName': 'Sumino', 'Affiliation': 'Department of Medicine, Washington University, St Louis, Mo.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'Department of Medicine, National Jewish University, Denver, Colo.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wenzel', 'Affiliation': 'Department of Medicine, Pittsburgh University, Pittsburgh, Pa.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Mass. Electronic address: eisrael@bwh.harvard.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.01.049']
1775,31678062,"Gastric bypass versus sleeve gastrectomy in patients with type 2 diabetes (Oseberg): a single-centre, triple-blind, randomised controlled trial.","BACKGROUND


For patients with obesity and type 2 diabetes, weight loss improves insulin sensitivity and β-cell function, and can induce remission of diabetes. The comparative efficacy of various bariatric procedures for the remission of type 2 diabetes has not been fully elucidated. We aimed to compare the effects of the two most common bariatric procedures, gastric bypass and sleeve gastrectomy, on remission of diabetes and β-cell function.
METHODS


We conducted a single-centre, triple-blind, randomised trial at Vestfold Hospital Trust (Tønsberg, Norway), in which patients (aged ≥18 years) with type 2 diabetes and obesity were randomly assigned (1:1) to receive gastric bypass or sleeve gastrectomy (the Oseberg study). Randomisation was performed with a computerised random number generator and a block size of 10. Treatment allocation was masked from participants, study personnel, and outcome assessors and was concealed with sealed opaque envelopes. Surgeons used identical skin incisions during both surgeries and were not involved in patient follow-up. The primary clinical outcome was the proportion of participants with complete remission of type 2 diabetes (HbA 1c  of ≤6·0% [42 mmol/mol] without the use of glucose-lowering medication) at 1 year after surgery. The primary physiological outcome was disposition index (a measure of β-cell function) at 1 year after surgery, as assessed by an intravenous glucose tolerance test. Primary outcomes were analysed in the intention-to-treat and per-protocol populations. This trial is ongoing and closed to recruitment, and is registered with ClinicalTrials.gov, NCT01778738.
FINDINGS


Between Oct 15, 2012, and Sept 1, 2017, 1305 patients who were preparing for bariatric surgery were screened, of whom 319 consecutive patients with type 2 diabetes were assessed for eligibility. 109 patients were enrolled and randomly assigned to gastric bypass (n=54) or sleeve gastrectomy (n=55). 107 (98%) of 109 patients completed 1-year follow-up, with one patient in each group withdrawing after surgery (per-protocol population). In the intention-to-treat population, diabetes remission rates were higher in the gastric bypass group than in the sleeve gastrectomy group (risk difference 27% [95% CI 10 to 44]; relative risk [RR] 1·57 [1·14 to 2·16], p=0·0054); results were similar in the per-protocol population (risk difference 27% [95% CI 10 to 45]; RR 1·57 [1·14 to 2·15], p=0·0036). In the intention-to-treat population, disposition index increased in both groups (between-group difference 55 [-111 to 220], p=0·52); results were similar in the per-protocol population (between-group difference 21 [-214 to 256], p=0.86). In the gastric bypass group, ten of 54 participants had early complications and 17 of 53 had late side-effects. In the sleeve gastrectomy group, eight of 55 participants had early complications and 22 of 54 had late side-effects. No deaths occurred in either group.
INTERPRETATION


Gastric bypass was found to be superior to sleeve gastrectomy for remission of type 2 diabetes at 1 year after surgery, and the two procedures had a similar beneficial effect on β-cell function. The use of gastric bypass as the preferred bariatric procedure for patients with obesity and type 2 diabetes could improve diabetes care and reduce related societal costs.
FUNDING


Morbid Obesity Centre, Vestfold Hospital Trust.",2019,"INTERPRETATION


Gastric bypass was found to be superior to sleeve gastrectomy for remission of type 2 diabetes at 1 year after surgery, and the two procedures had a similar beneficial effect on β-cell function.","['patients (aged ≥18 years) with type 2 diabetes and obesity', 'patients with obesity and type 2 diabetes', 'Between Oct 15, 2012, and Sept 1, 2017, 1305 patients who were preparing for bariatric surgery were screened, of whom 319 consecutive patients with type 2 diabetes', 'patients with type 2 diabetes (Oseberg', '109 patients']","['sleeve gastrectomy', 'gastric bypass and sleeve gastrectomy', 'gastric bypass', 'gastric bypass or sleeve gastrectomy', 'various bariatric procedures', 'Gastric bypass versus sleeve gastrectomy']","['diabetes remission rates', 'disposition index', 'intravenous glucose tolerance test', 'disposition index (a measure of β-cell function', 'proportion of participants with complete remission of type 2 diabetes', 'early complications', 'deaths', 'intention-to-treat and per-protocol populations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021911', 'cui_str': 'Intravenous Glucose Tolerance Test'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0231243', 'cui_str': 'Early complication (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",1305.0,0.153451,"INTERPRETATION


Gastric bypass was found to be superior to sleeve gastrectomy for remission of type 2 diabetes at 1 year after surgery, and the two procedures had a similar beneficial effect on β-cell function.","[{'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Hofsø', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Fatima', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Borgeraas', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Kåre Inge', 'Initials': 'KI', 'LastName': 'Birkeland', 'Affiliation': 'Department of Transplantation, Institute of Clinical Medicine, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hanne Løvdal', 'Initials': 'HL', 'LastName': 'Gulseth', 'Affiliation': 'Department of Chronic Diseases and Ageing, Norwegian Institute of Public Health, Oslo, Norway; Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jens Kristoffer', 'Initials': 'JK', 'LastName': 'Hertel', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Line Kristin', 'Initials': 'LK', 'LastName': 'Johnson', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Lindberg', 'Affiliation': 'Department of Laboratory Medicine, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Njord', 'Initials': 'N', 'LastName': 'Nordstrand', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Milada', 'Initials': 'M', 'LastName': 'Cvancarova Småstuen', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Department of Nutrition and Management, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Darko', 'Initials': 'D', 'LastName': 'Stefanovski', 'Affiliation': 'New Bolton Center, School of Veterinary Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Svanevik', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Department of Surgery, Vestfold Hospital Trust, Tønsberg, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Gretland Valderhaug', 'Affiliation': 'Department of Endocrinology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Sandbu', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Department of Surgery, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Jøran', 'Initials': 'J', 'LastName': 'Hjelmesæth', 'Affiliation': 'Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway; Department of Endocrinology, Morbid Obesity and Preventive Medicine, Institute of Clinical Medicine, University of Oslo, Norway. Electronic address: joran.hjelmeseth@siv.no.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30344-4']
1776,31675599,"A comparison of the hallux valgus angle, range of motion, and patient satisfaction after use of dynamic and static orthoses.","BACKGROUND


Conservative treatment is recommended for mild and moderate hallux valgus. The treatment may include two different types of orthoses: a dynamic orthosis and a static orthosis. The aim of this study was to compare the hallux valgus angle, hallux valgus range of motion, and patient satisfaction after the use of a dynamic and a static orthosis for the treatment of hallux valgus.
METHODS


Twenty-four participants contributed to this cross-over study. Participants were randomly allocated to orthotic treatments at the start. The hallux valgus angle and range of motion were measured using a goniometer. Pain, signs and symptoms, function in activities of daily living (ADL), function in sport and recreation, and foot and ankle-related quality of life (QOL) were measured using the Foot and Ankle Outcome Score (FAOS) questionnaire. The participants then switched to using the other orthosis. A one-way repeated measure ANOVA was conducted to compare the measured variables in subjects at 4 conditions before and after of using each orthosis.
RESULTS


There was a significant difference in the hallux valgus angle (p=0.001). The Bonferroni test indicated that both static and dynamic orthoses significantly decrease the angle of hallux valgus, respectively before static, after static (mean difference=-2.67, p=0.001) and before dynamic, after dynamic conditions (mean difference=-2.13, p=0.02). There was also a significant difference in subjects range of motion by using a dynamic orthosis in before dynamic, after dynamic conditions (mean difference=9.77, p=0.01). There was no significant difference in total FAOS score within the conditions (p=0.067).
CONCLUSION


The use of both static and dynamic orthoses for 1 month can reduce the hallux valgus angle up to 2-3°. To achieve better results, it is suggested to wear orthoses for longer time. The dynamic orthosis also increases the passive range of motion of the first metatarsophalangeal joint and it seems to be effective during walking.",2019,"There was also a significant difference in subjects range of motion by using a dynamic orthosis in before dynamic, after dynamic conditions (mean difference=9.77, p=0.01).","['Twenty-four participants contributed to this cross-over study', 'subjects at 4 conditions before and after of using each orthosis']","['dynamic and static orthoses', 'static and dynamic orthoses']","['Foot and Ankle Outcome Score (FAOS) questionnaire', 'total FAOS score', 'hallux valgus angle, hallux valgus range of motion, and patient satisfaction', 'angle of hallux valgus', 'Pain, signs and symptoms, function in activities of daily living (ADL), function in sport and recreation, and foot and ankle-related quality of life (QOL', 'hallux valgus angle']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C4277526', 'cui_str': 'Static Orthoses'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0180570', 'cui_str': 'Dynamic Orthoses'}]","[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0158458', 'cui_str': 'Acquired hallux valgus (disorder)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",24.0,0.0339542,"There was also a significant difference in subjects range of motion by using a dynamic orthosis in before dynamic, after dynamic conditions (mean difference=9.77, p=0.01).","[{'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Moulodi', 'Affiliation': 'Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 13487-15459, Iran. Electronic address: moulodi.n@tak.iums.ac.ir.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Kamyab', 'Affiliation': 'Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 13487-15459, Iran. Electronic address: kamyab.m@iums.ac.ir.'}, {'ForeName': 'Maede', 'Initials': 'M', 'LastName': 'Farzadi', 'Affiliation': 'Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 13487-15459, Iran. Electronic address: farzadi.maede@yahoo.com.'}]","Foot (Edinburgh, Scotland)",['10.1016/j.foot.2019.06.002']
1777,32408253,Effect of amino acids on IGF1 gene expression in human myotubes and skeletal muscle.,"OBJECTIVE


Insulin-like growth factor I (IGF1) is an important regulator of collagen and extracellular matrix protein expression. We aimed to evaluate the effect of amino acids (AAs) on expression of IGF1 and IGF1-dependent genes in human myotubes and skeletal muscle and supposed that AAs administration increases IGF1 levels in blood and expression of IGF1 and IGF1-dependent genes in trained skeletal muscle, thereby reducing training-induced muscle damage.
DESIGN


Human myotubes were incubated with Arg and Leu for 24 h. Then, the effects of long-term branched chain AAs administration (10 weeks, 0.1 g/kg body mass/day) to volunteers (six subjects per AAs and placebo groups) performing large training volumes regularly (cross country skiers, training twice a day) were examined.
RESULTS


Incubating the myotubes with AAs increases expression of IGF1 mRNA isoforms and IGF1 secretion by 2-3 times. In athletes, long-term AAs administration increased basal blood levels of IGF1 (~50%) and expression of IGF1Ea mRNA slightly in skeletal muscle. There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration. However, expression of these genes in the combined group (placebo + AAs; n = 12) significantly correlated with the expression of IGF1Ea mRNA in muscle and did not correlate with IGF1 levels in the blood.
CONCLUSIONS


AAs administration increases IGF1 expression in vitro and in vivo. To obtain more pronounced changes in expression of IGF1 and IGF1-dependent genes in skeletal muscle, it may be necessary to increase the dose and/or duration of AAs administration.",2020,"There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration.","['human myotubes and skeletal muscle', 'Human myotubes were incubated with Arg and Leu for 24\xa0h']","['Insulin-like growth factor', 'amino acids', 'amino acids (AAs']","['IGF1 gene expression', 'IGF1 expression', 'basal blood levels of IGF1', 'expression of IGF1 mRNA isoforms and IGF1 secretion', 'expression of IGF1Ea mRNA', 'expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle', 'IGF1 levels']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704336', 'cui_str': 'Skeletal muscle fiber'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}]","[{'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}]","[{'cui': 'C0202220', 'cui_str': 'Somatomedin-C measurement'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0972255', 'cui_str': 'type I collagen alpha 1'}, {'cui': 'C0024375', 'cui_str': 'Protein-lysine 6-oxidase'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",,0.0302591,"There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration.","[{'ForeName': 'Egor M', 'Initials': 'EM', 'LastName': 'Lednev', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation. Electronic address: ledhauz@gmail.com.'}, {'ForeName': 'Irina V', 'Initials': 'IV', 'LastName': 'Kravchenko', 'Affiliation': 'Federal Research Centre «Fundamentals of Biotechnology» of the Russian Academy of Sciences, 33 build 2, Leninsky prospect, Moscow 119071, Russian Federation.'}, {'ForeName': 'Vladimir A', 'Initials': 'VA', 'LastName': 'Furalyov', 'Affiliation': 'Federal Research Centre «Fundamentals of Biotechnology» of the Russian Academy of Sciences, 33 build 2, Leninsky prospect, Moscow 119071, Russian Federation.'}, {'ForeName': 'Evgeny A', 'Initials': 'EA', 'LastName': 'Lysenko', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Iulia S', 'Initials': 'IS', 'LastName': 'Lemesheva', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Alexandr A', 'Initials': 'AA', 'LastName': 'Grushin', 'Affiliation': 'Russian Olympic Committee, Luzhnetskaya Embankment 8, Russia, Moscow 119991, Russian Federation.'}, {'ForeName': 'Vadim E', 'Initials': 'VE', 'LastName': 'Dubrov', 'Affiliation': 'Lomonosov Moscow State University, Faculty of Fundamental Medicine, 27 build. 1, Lomonosovsky Prospekt, Moscow 119991, Russian Federation.'}, {'ForeName': 'Olga L', 'Initials': 'OL', 'LastName': 'Vinogradova', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Daniil V', 'Initials': 'DV', 'LastName': 'Popov', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101323']
1778,31302205,A randomized trial provided new evidence on the accuracy and efficiency of traditional vs. electronically annotated abstraction approaches in systematic reviews.,"OBJECTIVES


Data Abstraction Assistant (DAA) is a software for linking items abstracted into a data collection form for a systematic review to their locations in a study report. We conducted a randomized cross-over trial that compared DAA-facilitated single-data abstraction plus verification (""DAA verification""), single data abstraction plus verification (""regular verification""), and independent dual data abstraction plus adjudication (""independent abstraction"").
STUDY DESIGN AND SETTING


This study is an online randomized cross-over trial with 26 pairs of data abstractors. Each pair abstracted data from six articles, two per approach. Outcomes were the proportion of errors and time taken.
RESULTS


Overall proportion of errors was 17% for DAA verification, 16% for regular verification, and 15% for independent abstraction. DAA verification was associated with higher odds of errors when compared with regular verification (adjusted odds ratio [OR] = 1.08; 95% confidence interval [CI]: 0.99-1.17) or independent abstraction (adjusted OR = 1.12; 95% CI: 1.03-1.22). For each article, DAA verification took 20 minutes (95% CI: 1-40) longer than regular verification, but 46 minutes (95% CI: 26 to 66) shorter than independent abstraction.
CONCLUSION


Independent abstraction may only be necessary for complex data items. DAA provides an audit trail that is crucial for reproducible research.",2019,"For each article, DAA verification took 20 minutes (95% CI: 1-40) longer than regular verification, but 46 minutes (95% CI: 26 to 66) shorter than independent abstraction.
",['26 pairs of data abstractors'],"['DAA-facilitated single-data abstraction plus verification (""DAA verification']",['proportion of errors and time taken'],[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",,0.133149,"For each article, DAA verification took 20 minutes (95% CI: 1-40) longer than regular verification, but 46 minutes (95% CI: 26 to 66) shorter than independent abstraction.
","[{'ForeName': 'Tianjing', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, E6140, Baltimore, MD 21205, USA. Electronic address: tli19@jhu.edu.'}, {'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Saldanha', 'Affiliation': 'Center for Evidence Synthesis in Health, Department of Health Services, Policy, and Practice, Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA; Department of Epidemiology (Secondary), Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jap', 'Affiliation': 'Department of Health Services, Policy, and Practice, Center for Evidence Synthesis in Health, Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA.'}, {'ForeName': 'Bryant T', 'Initials': 'BT', 'LastName': 'Smith', 'Affiliation': 'Department of Health Services, Policy, and Practice, Center for Evidence Synthesis in Health, Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Canner', 'Affiliation': 'Department of Surgery, Center for Outcomes Research, Johns Hopkins School of Medicine, 720 Rutland Avenue, Turner 74, Baltimore, MD 21205, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Hutfless', 'Affiliation': 'Department of Surgery, Johns Hopkins School of Medicine, 600 N Wolfe St, Blalock 406, Baltimore, MD 21205, USA.'}, {'ForeName': 'Vernal', 'Initials': 'V', 'LastName': 'Branch', 'Affiliation': '119 Landings Drive, Suite 403, Mooresville, NC 28117, USA.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Carini', 'Affiliation': 'Department of Medicine, School of Medicine, University of California San Francisco, 3333 California Street, San Francisco, CA 94143, USA.'}, {'ForeName': 'Wiley', 'Initials': 'W', 'LastName': 'Chan', 'Affiliation': 'Internal Medicine, Kaiser Permanente Northwest, 500 NE Multnomah Street, Suite 100, KPB-2, Portland, OR 97232, USA.'}, {'ForeName': 'Berry', 'Initials': 'B', 'LastName': 'de Bruijn', 'Affiliation': 'Internal Medicine, National Research Council Canada, Digital Technologies Research Centre, 1200 Montreal Road, Ottawa, Ontario K1A 0R6, Canada.'}, {'ForeName': 'Byron C', 'Initials': 'BC', 'LastName': 'Wallace', 'Affiliation': 'Internal Medicine, College of Computer and Information Science, Northeastern University, 440 Huntington Avenue, 476 West Village H, Boston, MA 02115, USA.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Walsh', 'Affiliation': 'Internal Medicine, California Breast Cancer Organizations, 900 Kent Drive, Davis, CA 95616, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Whamond', 'Affiliation': 'Internal Medicine, Cochrane Consumer Network, 1421 Woodstock Road, Fredericton, New Brunswick E3C 1P2, Canada.'}, {'ForeName': 'M Hassan', 'Initials': 'MH', 'LastName': 'Murad', 'Affiliation': 'Internal Medicine, Evidence-based Practice Center, Mayo Clinic, 200 1st Street, Rochester, MN 55905, USA.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Sim', 'Affiliation': 'Department of Medicine, University of California San Francisco School of Medicine, San Francisco, CA, USA.'}, {'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Berlin', 'Affiliation': 'Internal Medicine, Epidemiology, Johnson & Johnson, 1125 Trenton-Harbourton Road, K3-Zone 1, Titusville, NJ 08560, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lau', 'Affiliation': 'Department of Health Services, Policy, and Practice, Center for Evidence Synthesis in Health, Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Dickersin', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, E6152, Baltimore, MD 21205, USA.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Schmid', 'Affiliation': 'Department of Biostatistics, Brown University School of Public Health, 121 South Main Street, Box G-S121-7, Providence, RI 02912, USA.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.07.005']
1779,31107775,The Effect of a Nurse-Led Cognitive Behavioral Protocol on Depressive Symptoms and Coping Strategies of Dementia Caregivers.,"BACKGROUND


Family caregivers of patients with dementia (PWD) often experience depressive symptoms and use poor coping strategies. Cognitive behavioral interventions may enhance positive appraisals of caregiving-related issues and the utilization of active coping strategies among caregivers, which may help prevent caregiver depression. However, there is a shortage of primary, community-based mental health services in China, and little research has been conducted on the effect of nurse-led mental health programs in this population.
PURPOSE


This study explored the effect of a nurse-led cognitive behavioral intervention on depressive symptoms and coping strategies among family caregivers of PWD in China.
METHODS


This randomized controlled trial used data from a sample of 112 caregivers screened from 276 potential participants in a city in southeastern China. The sample was randomly assigned to an intervention group (n = 56) and a control group (n = 56). The intervention group received five monthly in-home, nurse-led cognitive behavioral sessions and telephone consultations after each session. The control group received five monthly, short, general conversations with nurse interventionists at the participants' homes, in the hospital, or via telephone. Depressive symptoms, coping strategies, and the demographics of caregiving dyads were collected at Time 1 (baseline), Time 2 (the end of the 5-month intervention), and Time 3 (2-month follow-up). IBM SPSS Statistics Version 19.0 was used for data analysis.
RESULTS


Eighty-two participants (intervention group: n = 47, control group: n = 35) completed the three evaluations. No significant group differences were found in baseline characteristics between the two groups. The general linear model repeated-measures analysis of variance indicated a significant difference in depressive symptoms and active coping between groups over time, with p < .001 for the interaction between depressive symptoms and groups and p < .01 for the interaction between active coping and groups. A similar result did not occur for passive coping. The t tests further supported a significant interventional effect on participants' depressive symptoms and active coping.
CONCLUSIONS/IMPLICATIONS FOR PRACTICE


This nurse-led cognitive behavioral intervention was effective in decreasing depressive symptoms and improving active coping among study participants. The findings suggest the improvement of mental health services and social policies in China to support family caregivers of PWD.",2019,"Cognitive behavioral interventions may enhance positive appraisals of caregiving-related issues and the utilization of active coping strategies among caregivers, which may help prevent caregiver depression.","['sample of 112 caregivers screened from 276 potential participants in a city in southeastern China', 'Eighty-two participants (intervention group: n = 47, control group: n = 35', 'Family caregivers of patients with dementia (PWD', 'Dementia Caregivers', 'family caregivers of PWD in China']","['Nurse-Led Cognitive Behavioral Protocol', 'five monthly in-home, nurse-led cognitive behavioral sessions and telephone consultations', 'cognitive behavioral intervention', 'nurse-led cognitive behavioral intervention', 'Cognitive behavioral interventions']","['depressive symptoms and active coping', 'depressive symptoms', 'depressive symptoms and coping strategies', 'Depressive symptoms, coping strategies, and the demographics of caregiving dyads', ""participants' depressive symptoms and active coping""]","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0175745', 'cui_str': 'Telephone consultation'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",276.0,0.100422,"Cognitive behavioral interventions may enhance positive appraisals of caregiving-related issues and the utilization of active coping strategies among caregivers, which may help prevent caregiver depression.","[{'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Ruyi', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'MS, RN, Intermediate Laboratory Instructor, Faculty of Jinhua Polytechnic, Zhejiang Province, China.'}]",The journal of nursing research : JNR,['10.1097/jnr.0000000000000327']
1780,30279091,Communication-based interventions for increasing influenza vaccination rates among Aboriginal children: A randomised controlled trial.,"BACKGROUND


In Australia, the influenza vaccine is funded for Aboriginal and Torres Strait Islander (hereafter referred to as Aboriginal) children aged 6 months to <5 years old. In Victoria, only 2% of Aboriginal children are vaccinated against influenza.
OBJECTIVE


To evaluate whether sending a letter or sending a pamphlet directly to parents/guardians would improve influenza vaccine uptake amongst Aboriginal identified children.
DESIGN


The study involved a multi-arm, parallel, randomised controlled trial with two intervention groups and one control group.
PARTICIPANTS & SETTING


Participants included parents or guardians of Victorian children (aged 6 months to <5 years) who identified as Aboriginal. Households (n = 5534) were randomised (using a random number generator) to receive either a personalised letter (n = 1845), a pamphlet (n = 1845), or no direct communication (control) (n = 1844). The letter and the pamphlet were designed using the INSPIRE framework - a set of behaviour change techniques for action-oriented communication.
MAIN OUTCOME MEASURE


The proportion of households where all eligible children received the influenza vaccine between 2 May 2017 and 1 September 2017.
RESULTS


The control group's vaccination rate was 4.4%, higher than previous years. The pamphlet group achieved a similar vaccination rate (4.5%). The letter group's vaccination rate of 5.9% was significantly higher than the control group [χ 2  (1, n = 3689) = 4.33, p = .037].
CONCLUSIONS


Sending a personalised letter directly to parents/guardians was an effective strategy for increasing influenza vaccination among Aboriginal children. The ineffectiveness of the pamphlet may be due to the lack of personalisation and the authority associated with the letter. Additional research is required to understand participant responses to the material.
TRIAL REGISTRATION


This research was retrospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) on 13 September 2017 (ACTRN12617001315303).",2018,Sending a personalised letter directly to parents/guardians was an effective strategy for increasing influenza vaccination among Aboriginal children.,"['Households (n\u202f=\u202f5534', 'Aboriginal children', 'Aboriginal identified children', 'Aboriginal and Torres Strait Islander (hereafter referred to as Aboriginal) children aged 6\u202fmonths to <5\u202fyears old', 'Participants included parents or guardians of Victorian children (aged 6\u202fmonths to <5\u202fyears) who identified as Aboriginal']","['personalised letter (n\u202f=\u202f1845), a pamphlet (n\u202f=\u202f1845), or no direct communication (control', 'influenza vaccine', 'Communication-based interventions']","['influenza vaccine uptake', 'vaccination rate', 'influenza vaccination rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}]",5534.0,0.069986,Sending a personalised letter directly to parents/guardians was an effective strategy for increasing influenza vaccination among Aboriginal children.,"[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Borg', 'Affiliation': 'BehaviourWorks Australia, Monash Sustainable Development Institute, Monash University, Melbourne, Australia. Electronic address: kim.borg@monash.edu.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Sutton', 'Affiliation': 'Immunisation Section, Health Protection Branch, Department of Health and Human Services, Victorian State Government, Melbourne, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Beasley', 'Affiliation': 'Immunisation Section, Health Protection Branch, Department of Health and Human Services, Victorian State Government, Melbourne, Australia.'}, {'ForeName': 'Fraser', 'Initials': 'F', 'LastName': 'Tull', 'Affiliation': 'BehaviourWorks Australia, Monash Sustainable Development Institute, Monash University, Melbourne, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Faulkner', 'Affiliation': 'BehaviourWorks Australia, Monash Sustainable Development Institute, Monash University, Melbourne, Australia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Halliday', 'Affiliation': 'Public Sector Innovation, Department of Premier and Cabinet, Victorian State Government, Melbourne, Australia.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Knott', 'Affiliation': 'Behavioural Insights Unit, Department of Premier and Cabinet, Victorian State Government, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bragge', 'Affiliation': 'BehaviourWorks Australia, Monash Sustainable Development Institute, Monash University, Melbourne, Australia.'}]",Vaccine,['10.1016/j.vaccine.2018.09.020']
1781,30837170,"A randomized, double-blind, controlled clinical trial to evaluate the safety and immunogenicity of an intranasally administered trivalent inactivated influenza vaccine with adjuvant LTh(αK): A phase I study.","BACKGROUND


A nasal influenza vaccine has been available only in a live attenuated form, which limits the range of recipients to immune-competent individuals. The present study evaluated a newly developed intranasal inactivated influenza vaccine with a novel adjuvant, heat-labile enterotoxin (LT) derived from E. coli (LTh(αK)).
METHODS


The study was a randomized, double-blind, controlled phase I trial to evaluate the safety and immunogenicity of an intranasal vaccine containing the trivalent influenza HA antigen (7.5 µg each of A/California/7/09 (H1N1)-like virus, A/Victoria/210/2009 (H3N2) virus, and B/Brisbane/60/2008-like virus) in combination with 4 different doses of adjuvant LTh(αK) (7.5, 15, 30 or 45 μg) and 22.5 μg of influenza HA antigen alone (control vaccine). The vaccine was intranasally administered on Days 0 and 7. A safety evaluation commenced for 180 days, and hemagglutination inhibition (HI) antibody titers and nasal HA-specific IgA titers on Day 0 and Day 28 were assessed to determine whether an immunogenic response was elicited.
RESULTS


From November 2012 to September 2013, a total of 36 subjects were enrolled. Twenty-four subjects received an adjuvanted vaccine, and 12 subjects received a control vaccine. The most common adverse event (AE) was mild nasal discomfort, and systemic AEs were mild fatigue and headache. Only two subjects discontinued the study because of an AE (one had grade 3 fever, and one had nodal arrhythmia). In the group with 45 μg of LTh(αK), the seroprotection rates were 100%, 100% and 80%, and the nasal IgA conversion factors were 7.90, 7.46 and 12.27 for the A/H3N2, A/H1N1 and split B strains, respectively. Adjuvant LTh(αK) vaccine showed a significant enhancement in mucosal immunity in split B -specific IgA.
CONCLUSION


The intranasal inactivated influenza vaccine is generally safe, and the LTh(αK)-adjuvanted vaccine is more immunogenic than non-adjuvanted control vaccine. ClinicalTrials.gov Identifier: NCT03293732.",2019,"In the group with 45 μg of LTh(αK), the seroprotection rates were 100%, 100% and 80%, and the nasal IgA conversion factors were 7.90, 7.46 and 12.27 for the A/H3N2, A/H1N1 and split B strains, respectively.","['From November 2012 to September 2013, a total of 36 subjects were enrolled']","['intranasal inactivated influenza vaccine', 'intranasal vaccine containing the trivalent influenza HA antigen (7.5\u202fµg each of A/California/7/09 (H1N1)-like virus, A/Victoria/210/2009 (H3N2) virus, and B/Brisbane/60/2008-like virus) in combination with 4 different doses of adjuvant LTh(αK', 'control vaccine', 'vaccine', 'intranasally administered trivalent inactivated influenza vaccine with adjuvant LTh(αK', 'Adjuvant LTh(αK) vaccine', 'intranasal inactivated influenza vaccine with a novel adjuvant, heat-labile enterotoxin (LT) derived from E. coli (LTh(αK', 'adjuvanted vaccine', 'influenza HA antigen alone (control vaccine']","['mucosal immunity', 'nasal IgA conversion factors', 'nodal arrhythmia', 'seroprotection rates', 'hemagglutination inhibition (HI) antibody titers and nasal HA-specific IgA titers', 'safety and immunogenicity', 'mild nasal discomfort, and systemic AEs were mild fatigue and headache']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0014372', 'cui_str': 'Enterotoxins'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}]","[{'cui': 'C0282558', 'cui_str': 'Immunity, Mucosal'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0264893', 'cui_str': 'Nodal rhythm disorder (disorder)'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0858259', 'cui_str': 'Nasal discomfort'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",36.0,0.450411,"In the group with 45 μg of LTh(αK), the seroprotection rates were 100%, 100% and 80%, and the nasal IgA conversion factors were 7.90, 7.46 and 12.27 for the A/H3N2, A/H1N1 and split B strains, respectively.","[{'ForeName': 'Sung-Ching', 'Initials': 'SC', 'LastName': 'Pan', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Szu-Min', 'Initials': 'SM', 'LastName': 'Hsieh', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Feng', 'Initials': 'CF', 'LastName': 'Lin', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yu-Shen', 'Initials': 'YS', 'LastName': 'Hsu', 'Affiliation': 'Advagene Biopharma Co., Ltd., Taipei, Taiwan; Development Center for Biotechnology, New Taipei City, Taiwan.'}, {'ForeName': 'Mingi', 'Initials': 'M', 'LastName': 'Chang', 'Affiliation': 'Advagene Biopharma Co., Ltd., Taipei, Taiwan; Development Center for Biotechnology, New Taipei City, Taiwan.'}, {'ForeName': 'Shan-Chwen', 'Initials': 'SC', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; College of Medicine, National Taiwan University, Taipei, Taiwan. Electronic address: changsc@ntu.edu.tw.'}]",Vaccine,['10.1016/j.vaccine.2019.02.006']
1782,32408117,"Effects of saffron supplementation on glycemia and inflammation in patients with type 2 diabetes mellitus: A randomized double-blind, placebo-controlled clinical trial study.","BACKGROUND


New evidence indicates that overproduction of pro-inflammatory cytokines is responsible for the development of diabetes difficulties. Some herbals such as saffron, may control inflammation and improve the hyperglycemic states in diabetic patients. Therefore, this investigation aimed to assess the effects of saffron supplementation on fasting glucose and inflammatory markers levels in patients with type2 diabetes mellitus (T2DM).
METHODS


In this randomized double-blind, placebo-controlled clinical trial, 60 T2DM patients were randomly assigned into two groups as saffron and placebo (n = 30) receiving 100 mg/day saffron powder or starch capsules (1 capsule) for a duration of 8 weeks. Fasting blood sample was collected at baseline and at the end of the intervention. Fasting blood glucose (FBG) was immediately analyzed by the auto-analyzer. The serum level of Interleukin -6 (IL-6), Tumor necrosis factor-alpha (TNF-α), and Interleukin-10 (IL-10) were measured using ELISA assay by laboratory kits. Also, Real-time quantitative reverse transcription (RT-PCR) assay measured the expression level of TNF-α, IL-6, and IL-10 at the mRNA level.
RESULTS


Saffron supplementation significantly decreased the FBG levels within 8 weeks compared to placebo (130.93 ± 21.21 vs 135.13 ± 23.03 mg/dl, P = 0.012). Moreover, the serum level of TNF-α notably reduced in the saffron group compared to the placebo group (114.40 ± 24.28 vs 140.90 ± 25.49 pg/ml, P < 0.001). Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
CONCLUSION


In our study, it was indicated that saffron modulates glucose levels as well as inflammation status in T2DM patients through decreasing the expressions levels of some inflammatory mediators. Also, further investigations are necessary to confirm the positive effects of saffron as a complementary therapy for T2DM patients.",2020,"Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
","['60 T2DM patients', 'patients with type 2 diabetes mellitus', 'patients with type2 diabetes mellitus (T2DM', 'diabetic patients', 'T2DM patients']","['saffron supplementation', 'saffron and placebo (n\xa0=\xa030) receiving 100\xa0mg/day saffron powder or starch capsules', 'placebo']","['IL-6 mRNA levels', 'hyperglycemic states', 'glycemia and inflammation', 'Real-time quantitative reverse transcription (RT-PCR) assay measured the expression level of TNF-α, IL-6, and IL-10 at the mRNA level', 'FBG levels', 'expressions of TNF-α', 'fasting glucose and inflammatory markers levels', 'Fasting blood glucose (FBG', 'serum level of Interleukin\xa0-6 (IL-6), Tumor necrosis factor-alpha (TNF-α), and Interleukin-10 (IL-10', 'serum level of TNF-α', 'Fasting blood sample']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0035380', 'cui_str': 'Transcription, Reverse'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",60.0,0.491142,"Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014).
","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mobasseri', 'Affiliation': 'Department of Medicine, Endocrine Section, Endocrine Research Center, Tabriz University of Medical Sciences, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Aynaz', 'Initials': 'A', 'LastName': 'Tajaddini', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Pharmacology School of Medical Sciences, Faculty of Medicine, The University of New South Wales, Sydney, NSW, 2052, Australia.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': 'Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Meisam', 'Initials': 'M', 'LastName': 'Barati', 'Affiliation': 'Student Research Committee, Department of Cellular and Molecular Nutrition, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Moloud', 'Initials': 'M', 'LastName': 'Akbarzadeh', 'Affiliation': 'Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Nikpayam', 'Affiliation': 'Students Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Houshyar', 'Affiliation': 'Department of Medicine, Endocrine Section, Endocrine Research Center, Tabriz University of Medical Sciences, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Roshanravan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: roshanravann@tbzmed.ac.ir.'}, {'ForeName': 'Naimeh Mesri', 'Initials': 'NM', 'LastName': 'Alamdari', 'Affiliation': 'Student Research Committee, Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: mesrialamdari.n@tak.iums.ac.ir.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.04.031']
1783,30472302,Liposomal Bupivacaine Versus Bupivacaine Hydrochloride with Lidocaine during Midurethral Sling Placement: A Randomized Controlled Trial.,"STUDY OBJECTIVE


To study the effects of liposomal bupivacaine (LB) compared with bupivacaine hydrochloride with lidocaine on postoperative day 1 pain scores.
DESIGN


A randomized controlled trial (Canadian Task Force classification 1).
SETTING


An academic medical center within the department of female pelvic medicine and reconstructive surgery.
PATIENTS


Fifty-seven patients undergoing midurethral sling placement by a fellowship-trained urogynecologic surgeon and a fellow in female pelvic medicine and reconstructive surgery.
INTERVENTIONS


Fifty-seven patients were enrolled to participate in this study. There were 24 patients randomized to receive liposomal bupivacaine and 33 to receive a mixture of bupivacaine and lidocaine during the placement of a retropubic midurethral sling.
MEASUREMENTS AND MAIN RESULTS


Patients were given a diary of pain scales and asked to record their level of pain using the provided visual analog scale scored on a 100-mm Likert scale. Patients recorded their pain 4 hours after hospital discharge and on the night of surgery and their most intense pain each day thereafter for 7 days postoperatively. In addition, patients recorded total opioid and nonsteroidal anti-inflammatory drug consumption daily for 1 week postoperatively. Finally, the quality of recovery was assessed using the Quality of Recovery-15 (QoR-15) questionnaire scores. The median pain score in the experimental group was 20 mm (range, 0-80 mm) versus 30 mm (range, 0-60 mm) in the comparative group (p = .046). The postoperative day 1 QoR-15 scores were significantly lower in the LB group (124 [range, 54-150] vs 144 [range, 68-150], p = .007). There were no significant differences in opioid and nonsteroidal anti-inflammatory drug consumption, the remaining pain scores, or postoperative day 7 QoR-15 scores.
CONCLUSION


The results suggest the use of liposomal bupivacaine during retropubic midurethral sling placement does not provide a clinically significant difference in postoperative day 1 pain scores when compared with immediate-acting bupivacaine hydrochloride and lidocaine.",2019,"There were no significant differences in opioid and nonsteroidal anti-inflammatory drug consumption, the remaining pain scores, or postoperative day 7 QoR-15 scores.
","['An academic medical center within the department of female pelvic medicine and reconstructive surgery', 'Midurethral Sling Placement', 'Fifty-seven patients were enrolled to participate in this study', 'Fifty-seven patients undergoing']","['bupivacaine and lidocaine', 'liposomal bupivacaine', 'Liposomal Bupivacaine', 'retropubic midurethral sling', 'midurethral sling placement by a fellowship-trained urogynecologic surgeon and a fellow in female pelvic medicine and reconstructive surgery', 'bupivacaine hydrochloride and lidocaine', 'Bupivacaine Hydrochloride with Lidocaine', 'bupivacaine hydrochloride with lidocaine', 'liposomal bupivacaine (LB']","['total opioid and nonsteroidal anti-inflammatory drug consumption daily', 'quality of recovery', 'Quality of Recovery-15 (QoR-15) questionnaire scores', 'postoperative day 1 pain scores', 'opioid and nonsteroidal anti-inflammatory drug consumption, the remaining pain scores, or postoperative day 7 QoR-15 scores', 'postoperative day 1 QoR-15 scores', 'median pain score', 'diary of pain scales and asked to record their level of pain using the provided visual analog scale scored on a 100-mm Likert scale']","[{'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach (qualifier value)'}, {'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}]",57.0,0.160755,"There were no significant differences in opioid and nonsteroidal anti-inflammatory drug consumption, the remaining pain scores, or postoperative day 7 QoR-15 scores.
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Iwanoff', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Atlantic Health System, Morristown, New Jersey (Drs. Iwanoff and Salamon). Electronic address: ciwanoff@icloud.com.'}, {'ForeName': 'Charbel', 'Initials': 'C', 'LastName': 'Salamon', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Madigan Army Medical Center, Joint Base Lewis-McChord, Washington (Dr. Iwanoff).'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2018.11.005']
1784,31657794,Impact of High-intensity Interval Exercise and Moderate-Intensity Continuous Exercise on the Cardiac Troponin T Level at an Early Stage of Training.,"An elevation in cardiac troponin T (cTnT), as a highly specific biomarker of cardiomyocyte damage, after moderate-intensity continuous exercise (MCE) has been described. The exercise-induced cTnT response distorts the diagnostic role of the cTnT assay. Although high-intensity interval exercise (HIE) is growing in popularity and concerns remain about its safety, available data related to cTnT release after HIE is limited, which hampers the use of HIE as a health intervention. Here, we present three representative HIE protocols [traditional HIE (repeated 4 min cycling at 90% V̇O2max interspersed with 3 min rest, 200 kJ/session); sprint interval exercise (SIE, repeated 1 min cycling at 120% V̇O2max interspersed with 1.5 min rest, 200 kJ/session); and repeated sprint exercise (RSE, 40 x 6 s all-out sprints interspersed with 9 s rest)] and one representative MCE protocol (continuous cycling exercise at an intensity of 60% V̇O2max, 200 kJ/session). Forty-seven sedentary, overweight young women were randomly assigned to one of four groups (HIE, SIE, RSE, and MCE). Six bouts of respective exercise were performed by every single group, with each being 48 h apart. Meanwhile, for four groups, the duration of the entire testing period was identical, being 10 days. Before and after the first and final exercise bouts, an assessment was conducted of cTnT. The current study provides a frame of reference giving a clear picture of how a specific exercise session affects the circulating cTnT concentration at the early stage of training. The information may assist with clinical interpretations of post-exercise cTnT elevation and guide the prescription of exercise, especially for HIE.",2019,"An elevation in cardiac troponin T (cTnT), as a highly specific biomarker of cardiomyocyte damage, after moderate-intensity continuous exercise (MCE) has been described.","['Forty-seven sedentary, overweight young women']","['high-intensity interval exercise (HIE', 'V̇O2max interspersed with 3 min rest, 200 kJ/session); sprint interval exercise (SIE, repeated 1 min cycling at 120% V̇O2max interspersed with 1.5 min rest, 200 kJ/session); and repeated sprint exercise (RSE, 40 x 6 s all-out sprints interspersed with 9 s rest)] and one representative MCE protocol (continuous cycling exercise', 'High-intensity Interval Exercise and Moderate-Intensity Continuous Exercise']",['Cardiac Troponin T Level'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0256930', 'cui_str': 'mesochlorin e6 monoethylenediamine'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C3538889', 'cui_str': 'Cardiac troponin T (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",47.0,0.0471502,"An elevation in cardiac troponin T (cTnT), as a highly specific biomarker of cardiomyocyte damage, after moderate-intensity continuous exercise (MCE) has been described.","[{'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Physical Education College, Hebei Normal University; Hebei Provincial Key Lab of Measurement and Evaluation in Human Movement and Bio-Information.'}, {'ForeName': 'Jinlei', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'School of Health Sciences and Sports, Macao Polytechnic Institute; jnie@ipm.edu.mo.'}, {'ForeName': 'Zhaowei', 'Initials': 'Z', 'LastName': 'Kong', 'Affiliation': 'Faculty of Education, University of Macau.'}, {'ForeName': 'Xiangui', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Physical Education College, Hebei Normal University.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Physical Education College, Hebei Normal University.'}, {'ForeName': 'Qingde', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'School of Health Sciences and Sports, Macao Polytechnic Institute.'}]",Journal of visualized experiments : JoVE,['10.3791/60252']
1785,30657434,Feasibility and Acceptability of e-Screening and Brief Intervention and Tailored Text Messaging for Marijuana Use in Pregnancy.,"Background:  There are at present no evidence-based interventions for marijuana use during pregnancy, despite it being by far the most commonly used illicit drug during pregnancy. Lack of treatment-seeking, combined with implementation challenges, has limited the extent to which at-risk women receive interventions of any kind. This study sought to evaluate the feasibility and acceptability of two high-reach technology-based interventions: electronic screening and brief intervention (e-SBI) and tailored text messaging, delivered either alone or in combination.  Materials and Methods:  In this exploratory feasibility trial, pregnant women seeking prenatal care services and scoring positive for marijuana use risk ( n  = 45) were randomly assigned to e-SBI, text messaging, or e-SBI plus text messaging. We examined completion rates and acceptability ratings as a function of intervention condition and participant characteristics.  Results:  All participants assigned to receive the e-SBI ( n  = 30) were able to complete it during the in-clinic baseline session. Participants assigned to text messaging ( n  = 30) received a median of 24 text messages before giving birth; 6 of 30 (20%) chose to end text messages before giving birth. Acceptability ratings for the e-SBI were high, with most being above 4.4 on a 5-point scale ( e.g ., for ease of use, respectfulness, and helpfulness). Acceptability ratings for some aspects of the texting intervention were also high ( e.g ., for ease of understanding and respectfulness). Participants in the combined e-SBI plus texting condition chose to stop messages at a rate of 13.3% (2 of 15), versus 26.7% (4 of 15) in the texting-only condition ( p  = 0.37).  Conclusions:  These two high-reach intervention elements showed strong feasibility and modest to high acceptability. Future efforts evaluating efficacy are warranted, and should specifically examine the possibility that combining text messaging with a brief intervention may promote retention.",2019,"Participants in the combined e-SBI plus texting condition chose to stop messages at a rate of 13.3% (2 of 15), versus 26.7% (4 of 15) in the texting-only condition (p = 0.37).
","['Marijuana Use in Pregnancy', 'pregnant women seeking prenatal care services and scoring positive for marijuana use risk (n\u2009=\u200945']","['e-SBI, text messaging, or e-SBI plus text messaging', 'e-Screening and Brief Intervention and Tailored Text Messaging', 'two high-reach technology-based interventions: electronic screening and brief intervention (e-SBI) and tailored text messaging, delivered either alone or in combination']","['completion rates and acceptability ratings', 'Acceptability ratings', 'feasibility and acceptability']","[{'cui': 'C4316909', 'cui_str': 'Marijuana Use'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",45.0,0.0613142,"Participants in the combined e-SBI plus texting condition chose to stop messages at a rate of 13.3% (2 of 15), versus 26.7% (4 of 15) in the texting-only condition (p = 0.37).
","[{'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Ondersma', 'Affiliation': 'Merrill Palmer Skillman Institute, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Beatty', 'Affiliation': 'Merrill Palmer Skillman Institute, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Karoline S', 'Initials': 'KS', 'LastName': 'Puder', 'Affiliation': 'Department of Obstetrics & Gynecology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Janisse', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Dace S', 'Initials': 'DS', 'LastName': 'Svikis', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, Virginia.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7169']
1786,30657581,Comparison of genioglossus muscle activity and efficiency of dexmedetomidine or propofol during drug-induced sleep endoscopy in patients with obstructive sleep apnea/hypopnea syndrome.,"OBJECTIVE


The purpose of this study is to evaluate the haemodynamic and respiratory effects of dexmedetomidine vs. propofol in patients with OSAHS during the drug-induced sleep endoscopy (DISE), and analyze simultaneously the electromyography of genioglossus muscle.
PATIENTS AND METHODS


We conducted a study on 50 patients with OSAHS; patients were subjected to DISE with simultaneous polygraphic cardiorespiratory measurement and electromyography of genioglossus muscle. Patients undergoing DISE were divided in two groups: in Group A (19 M; 8 W) was administered propofol TCI and in Group B (16 M; 7 W) was administered dexmedetomidine TCI.
RESULTS


In Group A, a mean minimal SpO2 decreasing of 3.7% (p=0.000) and a mean SpO2 decreasing of 1.6% (p 0.001) was noticed, while there was an increase in BP20 of 14.8% (p=0.000) and HR20 of 11.1% (p=0.000). In Group B, it was showed a decreasing of mean minimal SpO2 and mean SpO2 values, about 1.8% (p=0.000) and 1.1% (p 0.009) respectively, while there was an increase of BP20 and HR20, about 8.7% (p=0.000) and 8% (p 0.002), respectively. Despite EMG activity comparing spontaneous sleep with propofol-DISE, there is a statistically significative change for the amplitude (p=0.040) and an increase of 7.01% for the area under the curve (AUC). Comparing spontaneous sleep with dexmedetomidine-DISE induced one, there is only an increase of 25.87% in the AUC.
CONCLUSIONS


A greater worsening of the cardio-respiratory basal values was noted after sleep induction with Propofol and same results were obtained confronting EMG of genioglossus muscle data.",2019,"In Group A, a mean minimal SpO2 decreasing of 3.7% (p=0.000) and a mean SpO2 decreasing of 1.6% (p 0.001) was noticed, while there was an increase in BP20 of 14.8% (p=0.000) and HR20 of 11.1% (p=0.000).","['patients with OSAHS during the drug-induced sleep endoscopy (DISE', '50 patients with OSAHS; patients', 'patients with obstructive sleep apnea/hypopnea syndrome', 'Patients undergoing DISE']","['dexmedetomidine or propofol', 'propofol TCI', 'dexmedetomidine TCI', 'dexmedetomidine vs. propofol', 'Propofol', 'DISE with simultaneous polygraphic cardiorespiratory measurement and electromyography of genioglossus muscle', 'dexmedetomidine-DISE']","['mean SpO2', 'BP20 and HR20', 'cardio-respiratory basal values', 'mean minimal SpO2', 'haemodynamic and respiratory effects', 'mean minimal SpO2 and mean SpO2 values', 'BP20']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0458082', 'cui_str': 'Drug-induced (qualifier value)'}, {'cui': 'C0396283', 'cui_str': 'Sleep nasendoscopy (procedure)'}, {'cui': 'C2748060', 'cui_str': 'Hypopnea syndrome'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0224194', 'cui_str': 'Structure of genioglossus muscle'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",50.0,0.0194739,"In Group A, a mean minimal SpO2 decreasing of 3.7% (p=0.000) and a mean SpO2 decreasing of 1.6% (p 0.001) was noticed, while there was an increase in BP20 of 14.8% (p=0.000) and HR20 of 11.1% (p=0.000).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Murabito', 'Affiliation': 'Department of General Surgery and Medical-Surgical Specialties, Section of Anesthesia and Intensive Care, University of Catania, Catania, Italy. paola_mp86@hotmail.it.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Serra', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zappia', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Maiolino', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cocuzza', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Castorina', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': ""D'Amico"", 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sciacca', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Di Mauro', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201901_16787']
1787,30651059,Improving Medication Adherence With Telemedicine for Adults With Severe Mental Illness.,"OBJECTIVE


The study evaluated a telephone call and text message intervention to improve adherence to medication among patients with severe mental illness.
METHODS


A randomized clinical trial was conducted, and outpatients with schizophrenia or bipolar disorder were assigned to the intervention group or to a usual care control group. The intervention was provided by trained nurses. Medication adherence was measured with the Medication Adherence Report Scale.
RESULTS


The study sample comprised 120 participants. Logistic regression analysis showed that intervention group participants were significantly more likely than control group participants to be medication adherent at 6 months (odds ratio=4.11, p=.007). The superiority of the intervention emerged during months 4 to 6. Social desirability, diagnosis, and medication did not affect the results.
CONCLUSIONS


Telemedicine via telephone can deliver low-threshold support to patients who are otherwise at high risk of progressive nonadherence to their psychotropic medication after 6 months.",2019,"Logistic regression analysis showed that intervention group participants were significantly more likely than control group participants to be medication adherent at 6 months (odds ratio=4.11, p=.007).","['patients with severe mental illness', 'Adults With Severe Mental Illness', 'outpatients with schizophrenia or bipolar disorder', '120 participants']","['Telemedicine', 'Telemedicine via telephone', 'usual care control group', 'telephone call and text message intervention']","['Medication adherence', 'Medication Adherence Report Scale', 'Social desirability, diagnosis, and medication']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0222045'}, {'cui': 'C0037408', 'cui_str': 'Social Desirability'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",120.0,0.0800332,"Logistic regression analysis showed that intervention group participants were significantly more likely than control group participants to be medication adherent at 6 months (odds ratio=4.11, p=.007).","[{'ForeName': 'Lara N', 'Initials': 'LN', 'LastName': 'Schulze', 'Affiliation': 'Institute for Community Medicine (Schulze, Stentzel, Hoffmann, van den Berg) and Department of Psychiatry and Psychotherapy (Schulze, Leipert, Schulte, Freyberger, Grabe), University Medicine Greifswald, Greifswald, Germany; Department for Psychiatry and Psychotherapy, HELIOS Hanseklinikum Stralsund, Stralsund, Germany (Freyberger); Psychosomatics and Psychotherapy, Bethanien Hospital for Psychiatry, Greifswald, Germany (Langosch).'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Stentzel', 'Affiliation': 'Institute for Community Medicine (Schulze, Stentzel, Hoffmann, van den Berg) and Department of Psychiatry and Psychotherapy (Schulze, Leipert, Schulte, Freyberger, Grabe), University Medicine Greifswald, Greifswald, Germany; Department for Psychiatry and Psychotherapy, HELIOS Hanseklinikum Stralsund, Stralsund, Germany (Freyberger); Psychosomatics and Psychotherapy, Bethanien Hospital for Psychiatry, Greifswald, Germany (Langosch).'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Leipert', 'Affiliation': 'Institute for Community Medicine (Schulze, Stentzel, Hoffmann, van den Berg) and Department of Psychiatry and Psychotherapy (Schulze, Leipert, Schulte, Freyberger, Grabe), University Medicine Greifswald, Greifswald, Germany; Department for Psychiatry and Psychotherapy, HELIOS Hanseklinikum Stralsund, Stralsund, Germany (Freyberger); Psychosomatics and Psychotherapy, Bethanien Hospital for Psychiatry, Greifswald, Germany (Langosch).'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Schulte', 'Affiliation': 'Institute for Community Medicine (Schulze, Stentzel, Hoffmann, van den Berg) and Department of Psychiatry and Psychotherapy (Schulze, Leipert, Schulte, Freyberger, Grabe), University Medicine Greifswald, Greifswald, Germany; Department for Psychiatry and Psychotherapy, HELIOS Hanseklinikum Stralsund, Stralsund, Germany (Freyberger); Psychosomatics and Psychotherapy, Bethanien Hospital for Psychiatry, Greifswald, Germany (Langosch).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Langosch', 'Affiliation': 'Institute for Community Medicine (Schulze, Stentzel, Hoffmann, van den Berg) and Department of Psychiatry and Psychotherapy (Schulze, Leipert, Schulte, Freyberger, Grabe), University Medicine Greifswald, Greifswald, Germany; Department for Psychiatry and Psychotherapy, HELIOS Hanseklinikum Stralsund, Stralsund, Germany (Freyberger); Psychosomatics and Psychotherapy, Bethanien Hospital for Psychiatry, Greifswald, Germany (Langosch).'}, {'ForeName': 'Harald J', 'Initials': 'HJ', 'LastName': 'Freyberger', 'Affiliation': 'Institute for Community Medicine (Schulze, Stentzel, Hoffmann, van den Berg) and Department of Psychiatry and Psychotherapy (Schulze, Leipert, Schulte, Freyberger, Grabe), University Medicine Greifswald, Greifswald, Germany; Department for Psychiatry and Psychotherapy, HELIOS Hanseklinikum Stralsund, Stralsund, Germany (Freyberger); Psychosomatics and Psychotherapy, Bethanien Hospital for Psychiatry, Greifswald, Germany (Langosch).'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hoffmann', 'Affiliation': 'Institute for Community Medicine (Schulze, Stentzel, Hoffmann, van den Berg) and Department of Psychiatry and Psychotherapy (Schulze, Leipert, Schulte, Freyberger, Grabe), University Medicine Greifswald, Greifswald, Germany; Department for Psychiatry and Psychotherapy, HELIOS Hanseklinikum Stralsund, Stralsund, Germany (Freyberger); Psychosomatics and Psychotherapy, Bethanien Hospital for Psychiatry, Greifswald, Germany (Langosch).'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Grabe', 'Affiliation': 'Institute for Community Medicine (Schulze, Stentzel, Hoffmann, van den Berg) and Department of Psychiatry and Psychotherapy (Schulze, Leipert, Schulte, Freyberger, Grabe), University Medicine Greifswald, Greifswald, Germany; Department for Psychiatry and Psychotherapy, HELIOS Hanseklinikum Stralsund, Stralsund, Germany (Freyberger); Psychosomatics and Psychotherapy, Bethanien Hospital for Psychiatry, Greifswald, Germany (Langosch).'}, {'ForeName': 'Neeltje', 'Initials': 'N', 'LastName': 'van den Berg', 'Affiliation': 'Institute for Community Medicine (Schulze, Stentzel, Hoffmann, van den Berg) and Department of Psychiatry and Psychotherapy (Schulze, Leipert, Schulte, Freyberger, Grabe), University Medicine Greifswald, Greifswald, Germany; Department for Psychiatry and Psychotherapy, HELIOS Hanseklinikum Stralsund, Stralsund, Germany (Freyberger); Psychosomatics and Psychotherapy, Bethanien Hospital for Psychiatry, Greifswald, Germany (Langosch).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201800286']
1788,30531253,Outcomes of patients with and without baseline lipid-lowering therapy undergoing revascularization for left main coronary artery disease: analysis from the EXCEL trial.,"OBJECTIVES


There is a paucity of data on the effect of baseline lipid-lowering therapy (LLT) in patients undergoing revascularization for left main (LM) coronary artery disease (CAD). We compared outcomes for patients with LMCAD randomized to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) according to the presence of baseline LLT in the EXCEL trial.
PATIENTS AND METHODS


The EXCEL trial randomized 1905 patients with LMCAD and SYNTAX scores up to 32 to PCI with everolimus-eluting stents versus CABG. Patients were categorized according to whether they were medically treated with LLT at baseline, and their outcomes were examined using multivariable Cox proportional hazards regression. The primary endpoint was a composite of death, stroke, or myocardial infarction at 3 years.
RESULTS


Among 1901 patients with known baseline LLT status, 1331 (70.0%) were medically treated with LLT at baseline. There were no significant differences between the PCI and CABG groups in the 3-year rates of the primary endpoint in patients with versus without baseline LLT (Pinteraction=0.62). Among patients with baseline LLT, the 3-year rate of ischemia-driven revascularization was higher after PCI compared with CABG (13.7 vs. 5.3%; adjusted hazard ratio=2.97; 95% confidence interval: 1.95-4.55; P<0.0001), in contrast to patients without baseline LLT (9.8 vs. 12.1%; adjusted hazard ratio=0.79; 95% confidence interval: 0.47-1.33; P=0.39) (Pinteraction=0.0003).
CONCLUSION


In the EXCEL trial, 3-year major adverse event rates after PCI versus CABG for LMCAD were similar and consistent in patients with and without LLT at baseline; however, revascularization during follow-up was more common after PCI compared with CABG in patients with baseline LLT, but not in those without baseline LLT.",2019,There were no significant differences between the PCI and CABG groups in the 3-year rates of the primary endpoint in patients with versus without baseline LLT (Pinteraction=0.62).,"['patients with LMCAD randomized to', 'patients undergoing revascularization for left main (LM) coronary artery disease (CAD', '1905 patients with LMCAD and SYNTAX scores up to 32 to PCI with', 'patients with and without baseline lipid-lowering therapy undergoing revascularization for left main coronary artery disease', '1901 patients with known baseline LLT status, 1331 (70.0%) were medically treated with LLT at baseline']","['everolimus-eluting stents versus CABG', 'baseline lipid-lowering therapy (LLT', 'CABG', 'LLT', 'percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG']","['3-year major adverse event rates', '3-year rate of ischemia-driven revascularization', 'composite of death, stroke, or myocardial infarction at 3 years', '3-year rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",1905.0,0.317087,There were no significant differences between the PCI and CABG groups in the 3-year rates of the primary endpoint in patients with versus without baseline LLT (Pinteraction=0.62).,"[{'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation.'}, {'ForeName': 'Yangbo', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Vrolix', 'Affiliation': 'Ziekenhuis Oost Limburg, Genk, Belgium.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Macaya', 'Affiliation': 'Hospital Clinico de San Carlos, Madrid, Spain.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'Department of Surgery, UH Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Imperial College of Science, Technology and Medicine, London, UK.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation.'}]",Coronary artery disease,['10.1097/MCA.0000000000000688']
1789,31685694,Estimating the social value of mechanical thrombectomy randomized trials on an established stroke network.,"BACKGROUND


Given the relative strength of prior mechanical thrombectomy (MT) data in face of the perceived poor natural history of emergent large vessel occlusion strokes, randomization to medical therapy during the recent clinical MT trials raised ethical challenges at individual and institutional levels despite overall clinical equipoise.
METHODS


In a thrombectomy stroke registry, we compared treatment rates preceding and following the SWIFT-PRIME and DAWN trials. Based on effect sizes of treatment in both trials, we estimated missed opportunities due to randomization to medical therapy and estimated the societal benefit resulting from additional patients who benefited as a result of these studies.
RESULTS


The average monthly thrombectomy rate in the SWIFT-PRIME time window increased from 14.1±4 patients-per-month (ppm) to 23.8±6 ppm (p<0·001). Twelve subjects were enrolled in SWIFT-PRIME and we estimated a missed opportunity of benefiting 2.3 of six subjects randomized to medical therapy. This was offset by providing treatment to an additional 9.7 ppm, resulting in an additional functional benefit to 3.7 ppm. Similarly, the thrombectomy rate in the DAWN window increased from 8.6±4 ppm pre-DAWN to 11.9±3.6 ppm post-DAWN (p<0.01). 38 subjects were enrolled in the DAWN trial with a missed opportunity to benefit eight of 16 subjects randomized to medical therapy. This was offset by the ability to offer MT to an additional 3.3 ppm, bringing definite benefit to an additional 1.65 ppm.
CONCLUSION


Completion of recent trials resulted in observable increases in rates of thrombectomy, translating to functional benefits that rapidly offset any missed opportunities due to randomization to medical therapy arms.",2020,"Similarly, the thrombectomy rate in the DAWN window increased from 8.6±4 ppm pre-DAWN to 11.9±3.6 ppm post-DAWN (p<0.01).","['38 subjects were enrolled in the DAWN trial with a missed opportunity to benefit eight of 16 subjects randomized to', 'Twelve subjects were enrolled in SWIFT-PRIME and we estimated a missed opportunity of benefiting 2.3 of six subjects randomized to']",['medical therapy'],[],"[{'cui': 'C1831581', 'cui_str': 'Subfamily Apodinae'}]","[{'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]",[],38.0,0.0553262,"Similarly, the thrombectomy rate in the DAWN window increased from 8.6±4 ppm pre-DAWN to 11.9±3.6 ppm post-DAWN (p<0.01).","[{'ForeName': 'Gabriel Martins', 'Initials': 'GM', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Neurology, Marcus Stroke & Neuroscience Center - Grady Memorial Hospital / Emory University, Atlanta, Georgia, United States.'}, {'ForeName': 'Diogo C', 'Initials': 'DC', 'LastName': 'Haussen', 'Affiliation': 'Department of Neurology, Marcus Stroke & Neuroscience Center - Grady Memorial Hospital / Emory University, Atlanta, Georgia, United States.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Bouslama', 'Affiliation': 'Department of Neurology, Marcus Stroke & Neuroscience Center - Grady Memorial Hospital / Emory University, Atlanta, Georgia, United States.'}, {'ForeName': 'Srikant', 'Initials': 'S', 'LastName': 'Rangaraju', 'Affiliation': 'Department of Neurology, Marcus Stroke & Neuroscience Center - Grady Memorial Hospital / Emory University, Atlanta, Georgia, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Frankel', 'Affiliation': 'Department of Neurology, Marcus Stroke & Neuroscience Center - Grady Memorial Hospital / Emory University, Atlanta, Georgia, United States.'}, {'ForeName': 'Raul G', 'Initials': 'RG', 'LastName': 'Nogueira', 'Affiliation': 'Department of Neurology, Marcus Stroke & Neuroscience Center - Grady Memorial Hospital / Emory University, Atlanta, Georgia, United States rnoguei@emory.edu.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-015204']
1790,32408011,"Cold versus hot adenoidectomy: A prospective, randomized controlled trial.","OBJECTIVE


Adenoidectomy can be performed using the cold method (mainly adenoid curettes) or the hot method (suction diathermy). Both techniques have similar intra and postoperative outcomes. However, the long-term clinical outcome of improving sleep disorder symptoms has not been well established. The objective of this study was to compare outcomes of hot method and cold method adenoidectomy one year following the surgery.
STUDY DESIGN


A prospective, randomized, single-blinded study of children under age 16 years who underwent adenoidectomy during the years 2014-2017. Patients were randomized to hot or cold adenoidectomy techniques.
SETTING


A tertiary health care referral center.
SUBJECTS AND METHODS


The final analysis included 58 children, mean age 5.9 years (range 1.2-15). The primary outcome was change in the Pediatric Sleep Questionnaire (PSQ) scores one month and one year after surgery. The secondary outcome was complication rate.
RESULTS


Clinical and demographic parameters were similar between the patients in the hot method group (n = 30) and the cold method group (n = 28). Adenoid size and estimated bleeding were similar between the groups. At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54). Improvement in PSQ scores was greater following hot than cold adenoidectomy at one year after surgery (+0.31 points vs. +0.22 points, p = 0.009).
CONCLUSION


Hot adenoidectomy is associated with better outcome than the cold technique, as reflected by PSQ scores one year after the surgery.",2020,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","['A tertiary health care referral center', 'children under age 16 years who underwent adenoidectomy during the years 2014-2017', '58 children, mean age 5.9 years (range 1.2-15']","['hot method and cold method adenoidectomy', 'Cold versus hot adenoidectomy', 'cold adenoidectomy', 'Hot adenoidectomy', 'hot or cold adenoidectomy techniques']","['sleep disorder symptoms', 'Pediatric Sleep Questionnaire (PSQ) scores', 'complication rate', 'PSQ scores', 'PSQ score', 'Adenoid size and estimated bleeding']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068880', 'cui_str': '1.2'}]","[{'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0426463', 'cui_str': 'Adenoids size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",58.0,0.101449,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","[{'ForeName': 'Shorook', 'Initials': 'S', 'LastName': ""Na'ara"", 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Sayegh', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Nassar', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Shinnawi', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Gil', 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Gordin', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel. Electronic address: a_gordin@rambam.health.gov.il.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110087']
1791,32408022,Supporting Syrian families displaced by armed conflict: A pilot randomized controlled trial of the Caregiver Support Intervention.,"BACKGROUND


The impact of armed conflict and displacement on children's mental health is strongly mediated by compromised parenting stemming from persistently high caregiver stress. Parenting interventions for refugees emphasize the acquisition of parenting knowledge and skills, while overlooking the deleterious effects of chronic stress on parenting. War Child Holland's Caregiver Support Intervention (CSI) aims to strengthen parenting by lowering stress and improving psychosocial wellbeing among refugee parents, while also increasing knowledge and skill related to positive parenting. The CSI is a nine-session group intervention delivered by non-specialist providers.
OBJECTIVE


We describe the findings of a two-arm pilot randomized controlled trial of the CSI with Syrian refugees in Lebanon. The primary aim was to test the feasibility of our study methodology prior to conducting a definitive RCT.
METHODS


We recruited 78 families (151 parents), who were randomized to the CSI or a waitlist control group. Data were collected at baseline and post-intervention.
RESULTS


Randomization was successful, retention was high (99 %), as was intervention completion (95 % among women, 86 % among men). Implementation fidelity was excellent. Blinding was largely, though not completely effective. The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management. CSI parents reported increased child psychosocial wellbeing. Control families showed no significant change on any variable.
CONCLUSIONS


Findings demonstrate the feasibility of our methodology for a definitive RCT, and suggest that the CSI shows promise as a scalable approach to strengthening parenting in refugee communities. Trial registration # ISRCTN33665023.",2020,"The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management.","['78 families (151 parents', ""children's mental health""]","['CSI', 'Caregiver Support Intervention', ""War Child Holland's Caregiver Support Intervention (CSI""]","['parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management', 'child psychosocial wellbeing']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",78.0,0.126032,"The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management.","[{'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Miller', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands. Electronic address: Kenneth.Miller@warchild.nl.'}, {'ForeName': 'Gabriela V', 'Initials': 'GV', 'LastName': 'Koppenol-Gonzalez', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands. Electronic address: Gabriela.Koppenol@warchild.nl.'}, {'ForeName': 'Maguy', 'Initials': 'M', 'LastName': 'Arnous', 'Affiliation': 'War Child Holland, Lebanon. Electronic address: Maguy.Arnous@warchild.nl.'}, {'ForeName': 'Fadila', 'Initials': 'F', 'LastName': 'Tossyeh', 'Affiliation': 'War Child Holland, Lebanon. Electronic address: Fadila.Tossyeh@warchild.nl.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Harvard University, United States. Electronic address: Alexandra.chen@post.harvard.edu.'}, {'ForeName': 'Nayla', 'Initials': 'N', 'LastName': 'Nahas', 'Affiliation': 'University of Balamand, Lebanon. Electronic address: Nayla.Nahas@balamand.edu.lb.'}, {'ForeName': 'Mark J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands; Amsterdam Institute of Social Science Research, University of Amsterdam, The Netherlands. Electronic address: Mark.Jordans@warchild.nl.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104512']
1792,32408038,Does eccentric-concentric resistance training improve early functional outcomes compared to concentric resistance training after total knee arthroplasty?,"BACKGROUND


Total knee arthroplasty (TKA) is the preferred surgical treatment of end stage osteoarthritis of the knee. However, up to 20% of patients are dissatisfied after TKA. Moreover, kinesiophobia is negatively correlated with functional outcomes.
RESEARCH QUESTION


The aim of this study was to compare the effects of combined concentric-eccentric versus concentric program on muscular strength assessment and quality of life, after total knee arthroplasty in elderly people.
METHOD


A prospective study including 20 subjects (72.1 ± 6.3 years), following a rehabilitation program after TKA was performed. Subjects were randomized in combined eccentricconcentric (ECC-CON, n = 10) versus concentric (CN, n = 10) early rehabilitation protocols. There were no significant differences between groups with respect to demographic data. Data were collected before and after protocol: performance-based physical function (timed up and go test, 10-meter walk test, isokinetic assessment), Selfreported physical function and quality of life (Lequesne-ISK, WOMAC, OAKHQOL) and kinesiophobia assessment (TSK-CF). The Gaussian distribution for the whole population of this study was tested by a Kolmogorov-Smirnov test. Statistical analysis was performed using non-parametric Mann-Whitney U or Fisher's exact probability test, as appropriate.
RESULTS AND CONCLUSION


Performance-based physical function tests showed a significant improvement after early rehabilitation in the ECC-CON group for timed up and go (p = 0.0002) and 10-meter walk test (p = 0.001). Operated hamstring muscle peak torque was significantly improved in the ECC-CON group (p = 0.03). Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04). Self-reported kinesiophobia significantly decreased after rehabilitation in both groups (p = 0.01) whilst there were no differences between groups. Early combined eccentric-concentric rehabilitation after TKA appears to be associated with improved outcomes compared to classic concentric rehabilitation protocols, on both physical function and quality of life. This information is new. Assessment and care of kinesiophobia should be considered in rehabilitation protocols standards.",2020,Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04).,"['elderly people', '20 subjects (72.1\u202f±\u202f6.3 years), following a rehabilitation program after TKA was performed']","['combined concentric-eccentric versus concentric program', 'Total knee arthroplasty (TKA', 'concentric resistance training', 'eccentric-concentric resistance training', 'combined eccentricconcentric (ECC-CON, n\u202f=\u202f10) versus concentric (CN, n\u202f=\u202f10) early rehabilitation protocols', 'ECC-CON']","['Self-reported kinesiophobia', 'physical function and quality of life', 'Operated hamstring muscle peak torque', 'performance-based physical function (timed up and go test, 10-meter walk test, isokinetic assessment), Selfreported physical function and quality of life ', 'muscular strength assessment and quality of life', 'Self-reported physical function and quality of life tests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4077283', 'cui_str': '67Ga-ethylenecysteamine cysteine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",20.0,0.023474,Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04).,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Teissier', 'Affiliation': 'Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; Department of Orthopaedic Surgery, Hospital Cochin, APHP, Université Paris 5, Paris, France. Electronic address: vic.teissier@gmail.com.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Leclercq', 'Affiliation': ""Université d'Orléans, COST, 45100, Orléans, France. Electronic address: apa.olivet@orpea.net.""}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Schiano-Lomoriello', 'Affiliation': 'Université Orléans, CIAMS, 45067, Orléans, France; CIAMS, Université Paris-Sud, Université Paris-Saclay, 91405, Orsay Cedex, France. Electronic address: sandrine.schiano-lomoriello@univ-orleans.fr.'}, {'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Nizard', 'Affiliation': 'Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; 6-AP-HP, Hôpital Lariboisière, Service de chirurgie orthopédique, F-75010, Paris, France. Electronic address: remy.nizard@aphp.fr.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Portier', 'Affiliation': ""Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; Université d'Orléans, COST, 45100, Orléans, France. Electronic address: hugues.portier@univ-orleans.fr.""}]",Gait & posture,['10.1016/j.gaitpost.2020.04.020']
1793,31721979,Occurence of First and Recurrent Major Adverse Cardiovascular Events With Liraglutide Treatment Among Patients With Type 2 Diabetes and High Risk of Cardiovascular Events: A Post Hoc Analysis of a Randomized Clinical Trial.,"Importance


After the occurrence of nonfatal cardiovascular events, recurrent events are highly likely. Most cardiovascular outcomes trials analyze first events only; extending analyses to first and recurrent (total) events can provide clinically meaningful information.
Objective


To investigate whether liraglutide is associated with reduced first and recurrent total major adverse cardiovascular events (MACE) compared with placebo among patients with type 2 diabetes and high risk of cardiovascular events.
Design, Setting, and Participants


This post hoc analysis of the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) randomized, double-blind, clinical trial included data from patients with type 2 diabetes who had established or were at high risk for cardiovascular disease at 410 sites in 32 countries from August 2010, to December 2015. Data analysis was performed from August 15, 2016, to July 5, 2019.
Interventions


Patients were randomized 1:1 to receive liraglutide (up to 1.8 mg per day) or placebo, both with standard care, for 3.5 to 5.0 years.
Main Outcomes and Measures


Assessed outcomes were MACE (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke), expanded MACE (primary MACE plus coronary revascularization and hospitalization for heart failure or unstable angina pectoris), and the individual end points.
Results


The 9340 LEADER trial participants (6003 [64.3%] male; mean [SD] age, 64.3 [7.2] years) experienced 1605 total MACE (1302 first and 303 recurrent events; median follow-up, 3.8 years [range, 0-5.2 years]). Patients who experienced any MACE were older (1 MACE: mean [SD] age, 65.6 [8.0] years; >1 MACE: 65.7 [7.9] years) and had diabetes for longer duration (1 MACE: mean [SD] duration, 13.4 [8.3] years; >1 MACE: 14.4 [8.7] years) compared with patients without MACE (mean [SD] age, 64.1 [7.1] years; mean [SD] duration, 12.7 [7.9] years). Fewer first and recurrent MACE occurred in the liraglutide group (n = 4668; 608 first and 127 recurrent events) than in the placebo group (n = 4672; 694 first and 176 recurrent events). Liraglutide was associated with a 15.7% relative risk reduction in total MACE (hazard ratio [HR], 0.84; 95% CI, 0.76-0.93) and a 13.4% reduction in total expanded MACE (HR, 0.87; 95% CI, 0.81-0.93) compared with placebo. For most individual cardiovascular end points, liraglutide was associated with lower risk vs placebo.
Conclusions and Relevance


These results suggest that liraglutide treatment is associated with reduced total MACE compared with placebo among patients with type 2 diabetes and high risk of cardiovascular events. This analysis supports the findings of an absolute benefit of liraglutide treatment with respect to the overall burden of cardiovascular events in this high-risk patient population.
Trial Registration


ClinicalTrials.gov identifier: NCT01179048.",2019,"Liraglutide was associated with a 15.7% relative risk reduction in total MACE (hazard ratio [HR], 0.84; 95% CI, 0.76-0.93) and a 13.4% reduction in total expanded MACE (HR, 0.87; 95% CI, 0.81-0.93) compared with placebo.","['patients with type 2 diabetes and high risk of cardiovascular events', 'The 9340 LEADER trial participants (6003 [64.3%] male; mean [SD] age, 64.3 [7.2] years) experienced 1605 total MACE (1302 first and 303 recurrent events; median follow-up, 3.8 years [range, 0-5.2 years', 'patients without MACE (mean [SD] age, 64.1 [7.1] years; mean [SD] duration, 12.7 [7.9] years', 'patients with type 2 diabetes who had established or were at high risk for cardiovascular disease at 410 sites in 32 countries from August 2010, to December 2015', 'Diabetes', 'Patients With Type', 'Patients who experienced any MACE were older (1 MACE: mean [SD] age, 65.6 [8.0] years; >1 MACE: 65.7 [7.9] years) and had diabetes for longer duration (1 MACE: mean [SD] duration, 13.4 [8.3] years', '2 Diabetes and High Risk of Cardiovascular Events']","['placebo', 'liraglutide', 'Liraglutide']","['total expanded MACE', 'MACE (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke), expanded MACE (primary MACE plus coronary revascularization and hospitalization for heart failure or unstable angina pectoris), and the individual end points', 'Occurence of First and Recurrent Major Adverse Cardiovascular Events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517546', 'cui_str': '12.7 (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C4517558', 'cui_str': 'Thirteen point four'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.134549,"Liraglutide was associated with a 15.7% relative risk reduction in total MACE (hazard ratio [HR], 0.84; 95% CI, 0.76-0.93) and a 13.4% reduction in total expanded MACE (HR, 0.87; 95% CI, 0.81-0.93) compared with placebo.","[{'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Diabetes Research Unit Cymru, Swansea University Medical School, Swansea, United Kingdom.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Department of Medicine, University of North Carolina School of Medicine at Chapel Hill, Chapel Hill.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ørsted', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St Josef Hospital (Ruhr-Universität Bochum), Bochum, Germany.'}]",JAMA cardiology,['10.1001/jamacardio.2019.3080']
1794,30511312,Comparison of inflammatory stress response between laparoscopic and open approach for pediatric inguinal hernia repair in children.,"BACKGROUND


The aim of this study was to compare inflammatory stress response between laparoscopic percutaneous inguinal ring suturing (PIRS) and open modified Marcy technique for pediatric inguinal hernia repair.
METHODS


From May 2017 to April 2018, 32 male children with median age of 4.5 years undergoing inguinal hernia repair were included in randomized controlled trial. The patients were divided in two groups, by using random number generator, depending on surgical approach. The blood was tested in three time frames for white blood cells count (WBC), C-reactive protein (CRP), Interleukin-6 (IL-6), and tumor necrosis factor alpha (TNF-α).
RESULTS


Significant increase in concentration for all inflammatory biomarkers, that occur over time, has been found (p < 0.001 for all). Additionally, it was also found that the type of surgery significantly influenced the level of WBC, CRP, and IL-6 with Marcy showing a higher level of inflammatory response (WBC 11.4 ± 3.1 × 10 9 /L; CRP 11.5 mg/L; IL-6 11.0 pg/mL) than the PIRS (WBC 7.6 ± 1.6 × 10 9 /L; CRP 0.8 mg/L; IL-6 2.0 pg/mL) (p < 0.001 for all). Similar pattern was also found for TNF-α (Marcy 16.8 pg/mL; PIRS 10.1 pg/mL), but correlation between surgery type and concentration of this biomarker was significant only at the 0.1 level (p = 0.055). The mean operation time was significantly shorter (9 ± 2 min) in PIRS group compared to Marcy group (25 ± 7 min) (p < 0.001). Significantly lower median of visual analog scale score (VAS) was found in PIRS group (VAS = 2) compared to Marcy group (VAS = 6) (p < 0.001).
CONCLUSIONS


Use of laparoscopic (PIRS) technique in children shows significantly lower surgical stress in comparison to open hernia repair.",2019,"Significantly lower median of visual analog scale score (VAS) was found in PIRS group (VAS = 2) compared to Marcy group (VAS = 6) (p < 0.001).
","['pediatric inguinal hernia repair in children', 'From May 2017 to April 2018, 32 male children with median age of 4.5\xa0years undergoing inguinal hernia repair', 'pediatric inguinal hernia repair']","['laparoscopic (PIRS) technique', 'laparoscopic percutaneous inguinal ring suturing (PIRS) and open modified Marcy technique', 'laparoscopic and open approach']","['mean operation time', 'inflammatory stress response', 'white blood cells count (WBC), C-reactive protein (CRP), Interleukin-6 (IL-6), and tumor necrosis factor alpha (TNF-α', 'TNF-α', 'level of WBC, CRP, and IL-6 with Marcy showing a higher level of inflammatory response', 'concentration for all inflammatory biomarkers', 'median of visual analog scale score (VAS', 'surgical stress']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0225226', 'cui_str': 'Inguinal Ring'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",32.0,0.103962,"Significantly lower median of visual analog scale score (VAS) was found in PIRS group (VAS = 2) compared to Marcy group (VAS = 6) (p < 0.001).
","[{'ForeName': 'Miro', 'Initials': 'M', 'LastName': 'Jukić', 'Affiliation': 'Department of Pediatric Surgery, University Hospital of Split, Spinčićeva 1, 21 000, Split, Croatia. mirojukic.mefst@gmail.com.'}, {'ForeName': 'Zenon', 'Initials': 'Z', 'LastName': 'Pogorelić', 'Affiliation': 'Department of Pediatric Surgery, University Hospital of Split, Spinčićeva 1, 21 000, Split, Croatia.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Šupe-Domić', 'Affiliation': 'Department of Medical Laboratory Diagnostics, University Hospital of Split, Spinčićeva 1, Split, Croatia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Jerončić', 'Affiliation': 'Department of Research in Biomedicine and Health, School of Medicine, University of Split, Šoltanska 2, Split, Croatia.'}]",Surgical endoscopy,['10.1007/s00464-018-06611-y']
1795,30465228,Dinutuximab Beta for Treating Neuroblastoma: An Evidence Review Group and Decision Support Unit Perspective of a NICE Single Technology Appraisal.,"As part of its Single Technology Appraisal (STA) process, the UK National Institute for Health and Care Excellence (NICE) invited the manufacturer (EUSA Pharma) of dinutuximab beta (Qarziba ® ) to submit evidence of its clinical and cost effectiveness for treating neuroblastoma. The BMJ Technology Assessment Group (BMJ-TAG) was commissioned to act as the Evidence Review Group (ERG), reviewing the submission from the company. The Decision Support Unit (DSU) was commissioned to review additional evidence submitted by the company and to undertake further analyses. This article presents the critical review of the company's submissions by the ERG and DSU, further analyses undertaken by the DSU, and the outcome of the NICE guidance. The clinical effectiveness for dinutuximab beta was derived from a phase III randomised controlled trial (RCT) that assessed the safety and efficacy of the addition of interleukin (IL)-2 to dinutuximab beta plus isotretinoin. This trial did not inform the relative effectiveness of dinutuximab beta versus isotretinoin alone, which was established practice in the UK for maintenance treatment. In the absence of direct evidence, the company initially conducted a naïve indirect treatment comparison against a historical control, and later performed a matching-adjusted indirect comparison (MAIC) against the isotretinoin arm of an RCT comparing dinutuximab alpha and isotretinoin. The company submitted a partitioned survival analysis model that calculated the incremental cost effectiveness of dinutuximab beta versus isotretinoin. The company's original incremental cost-effectiveness ratio (ICER) was £22,338 per quality-adjusted life-year (QALY) gained. However, the ERG were concerned that the company's ICER was not suitable for decision making, and thus carried out initial exploratory analysis as a first step to overcome the naïve estimation of treatment effectiveness in the model. The ERG's analysis estimated an ICER of £111,858 per QALY gained. In their revised analysis incorporating the MAIC and other changes as requested by the appraisal committee, the company's ICER was £24,661 per QALY gained. When the DSU incorporated longer-term isotretinoin data and made corrections to the model, the ICER increased to between £62,886 and £87,164 per QALY gained depending on the choice of survival model. A confidential Patient Access Scheme (PAS) decreased the ICERs. The ICERs with the PAS were over £40,000 per QALY gained, but the NICE committee additionally considered the patient population and its size, the disease severity, the potential for significant survival benefit and uncaptured health benefits, and recommended dinutuximab beta as a treatment option, subject to the company providing the agreed discount in the PAS.",2019,"The company's original incremental cost-effectiveness ratio (ICER) was £22,338 per quality-adjusted life-year (QALY) gained.",['Treating Neuroblastoma'],"['interleukin (IL)-2 to dinutuximab beta plus isotretinoin', 'dinutuximab beta versus isotretinoin alone', 'dinutuximab beta versus isotretinoin']","['safety and efficacy', 'incremental cost-effectiveness ratio (ICER', 'ICER']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}]","[{'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0281581', 'cui_str': 'dinutuximab'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0230631,"The company's original incremental cost-effectiveness ratio (ICER) was £22,338 per quality-adjusted life-year (QALY) gained.","[{'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Pennington', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. b.pennington@sheffield.ac.uk.'}, {'ForeName': 'Shije', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Barton', 'Affiliation': 'BMJ Technology Assessment Group, BMA House, Tavistock Square, London, WC1H 9JR, UK.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Bacelar', 'Affiliation': 'BMJ Technology Assessment Group, BMA House, Tavistock Square, London, WC1H 9JR, UK.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Edwards', 'Affiliation': 'BMJ Technology Assessment Group, BMA House, Tavistock Square, London, WC1H 9JR, UK.'}]",PharmacoEconomics,['10.1007/s40273-018-0744-0']
1796,31583813,Effects of family constellation seminars on itch in patients with atopic dermatitis and psoriasis: A patient preference controlled trial.,"Family dynamics play a major role in itch related dermatoses. The aim of the study was to evaluate the effectiveness of family constellation seminars (FCS) in the decrease of itch in atopic dermatitis (AD) and psoriasis. Thirty-one adult patients with chronic itch (16 with AD and 15 with psoriasis) were allocated to intervention group (FCS + G) and control group (CG). Patients from FCS + G have participated in a series of four FCS for 3 months. During the study period, all patients used only emollients. Itch was evaluated by 27-item questionnaire and skin condition was evaluated by SCORAD and PASI. The severity of itch in FCS + G decreased (Median; (25%;75%)) from 8.42 (6.57;11.92) initially to 4.78 (1.36;9.14); p < .01 after 1 month and (0.61 (0;6.66); p < .001) after 9 months after the psychological intervention with no significant changes in the CG. In the patients with AD in the FCS + G, SCORAD decreased (21.5 (14.4;40); 14.1 (7.3;15.5) p < .05; 7.2 (3.6;11); p < .05). In the FCS + G, itch decreased both in patients with AD and psoriasis, with less significant visible changes of skin in patients with psoriasis. Participation in FCS in a series of four seminars has high effect (r = .53) on reduction of itch and high effect (r = .74) on improvement of AD signs with lower effect on skin condition in patients with psoriasis for 4 months. Positive effect of FCS gradually increases during at least 9 months. Further studies for understanding FCS influence on the patients with itch are needed.",2019,Participation in FCS in a series of 4 seminars has high effect (r = 0.53) on reduction of itch and high effect (r = 0.74) on improvement of AD signs with lower effect on skin condition in patients with psoriasis for 4 months.,"['patients with atopic dermatitis and psoriasis', '31 adult patients with chronic itch (16 with AD and 15 with psoriasis', 'patients with psoriasis', 'atopic dermatitis (AD) and psoriasis']","['intervention group (FCS\u2009+\u2009G) and control group (CG', 'FCS', 'family constellation seminars (FCS', 'family constellation seminars']","['skin condition', 'severity of itch in FCS\u2009+\u2009G', '27-item questionnaire and skin condition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C1719933', 'cui_str': 'Skin condition'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",31.0,0.0164296,Participation in FCS in a series of 4 seminars has high effect (r = 0.53) on reduction of itch and high effect (r = 0.74) on improvement of AD signs with lower effect on skin condition in patients with psoriasis for 4 months.,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Jafferany', 'Affiliation': 'College of Medicine, Central Michigan University, Saginaw, Michigan.'}, {'ForeName': 'Szergej', 'Initials': 'S', 'LastName': 'Capec', 'Affiliation': 'Faculty of Medicine and Dentistry, Palacky University, Olomouc, Czech Republic.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Yaremkevych', 'Affiliation': 'Medical Centre ""Asclepius"", Uzhgorod, Ukraine.'}, {'ForeName': 'Yuriy', 'Initials': 'Y', 'LastName': 'Andrashko', 'Affiliation': 'Medical Centre ""Asclepius"", Uzhgorod, Ukraine.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Capec', 'Affiliation': 'Faculty of Medicine and Dentistry, Palacky University, Olomouc, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Petrek', 'Affiliation': 'Faculty of Medicine and Dentistry, Palacky University, Olomouc, Czech Republic.'}]",Dermatologic therapy,['10.1111/dth.13100']
1797,31623493,Immediate and controlled-release pregabalin for the treatment of epilepsy.,"Introduction : Epilepsy is a common neurological disease requiring complex therapies, which are unable to achieve seizure control in 30% of patients. Poor adherence has been recognized as a possible determinant of drug-resistance. Prolonged-release formulations of antiepileptic drugs might help increase adherence and minimize side effects. Areas covered : Pregabalin (PGB) has peculiar pharmacodynamics and almost ideal pharmacokinetics, except for a short half-life and therefore requiring multiple daily dosing. PGB immediate-release (IR) is effective in focal-onset epilepsy (FOE), neuropathic pain, generalized anxiety disorder, and fibromyalgia, despite some tolerability issues, especially at higher doses. The controlled-release formulation (CR) shares PGB IR advantages and requires slight dose adjustments to guarantee bioavailability. In 2014, PGB CR (165 and 330 mg/day) failed to prove superior to placebo in a randomized placebo-controlled trial on 323 subjects with drug-resistant FOE, although it was just as tolerable. Therefore, PGB CR is not currently licensed for epilepsy. Expert opinion : Considering the disappointing results of the only controlled trial, PGB CR is unlikely to become an established epilepsy treatment anytime soon. Nevertheless, given its peculiar properties and potential advantages, PGB (in either formulation) should be further evaluated in specific populations of patients, especially fragile subjects with several comorbidities and complex polytherapies.",2019,The controlled-release formulation (PGB CR) shares PGB IR advantages and requires slight dose adjustments to guarantee bioavailability.,"['epilepsy', '323 subjects with drug-resistant FOE']","['placebo', 'Pregabalin (PGB', 'PGB immediate-release (IR', 'PGB CR']",[],"[{'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0033557', 'cui_str': 'PGB'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",[],323.0,0.015637,The controlled-release formulation (PGB CR) shares PGB IR advantages and requires slight dose adjustments to guarantee bioavailability.,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Morano', 'Affiliation': 'Neurology Unit, Department of Human Neurosciences, ""Sapienza"" University, Rome, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Palleria', 'Affiliation': 'Science of Health Department, School of Medicine, University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Citraro', 'Affiliation': 'Science of Health Department, School of Medicine, University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nesci', 'Affiliation': 'Science of Health Department, School of Medicine, University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'De Caro', 'Affiliation': 'Science of Health Department, School of Medicine, University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Anna Teresa', 'Initials': 'AT', 'LastName': 'Giallonardo', 'Affiliation': 'Neurology Unit, Department of Human Neurosciences, ""Sapienza"" University, Rome, Italy.'}, {'ForeName': 'Giovambattista', 'Initials': 'G', 'LastName': 'De Sarro', 'Affiliation': 'Science of Health Department, School of Medicine, University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Russo', 'Affiliation': 'Science of Health Department, School of Medicine, University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Bonaventura', 'Affiliation': 'Neurology Unit, Department of Human Neurosciences, ""Sapienza"" University, Rome, Italy.'}]",Expert review of neurotherapeutics,['10.1080/14737175.2019.1681265']
1798,30656648,A 1-year perspective on goal-directed therapy in elderly with hip fracture: Secondary outcomes.,"BACKGROUND


We have previously reported inconclusive results from a randomized controlled trial in elderly with hip-fracture comparing intra-operative goal-directed therapy with routine fluid treatment. Now we aimed to describe and compare secondary outcomes at 4 months and 1 year follow-up and to analyze the cost-effectiveness.
METHODS


Patients with hip fracture (age ≥70) were randomized for GDT or routine fluid treatment (RFT). The secondary outcomes were long-term survival, complications, number of hospital readmissions, and quality of life (EQ-5D) changes. Additionally, cost effectiveness was analyzed by an analytic tool which combines the clinical effectiveness, quality of life changes and costs.
RESULTS


Patient data (GDT n = 74; RFT n = 75) were analyzed on an intention to treat basis. Statistically significant differences (GDT vs RFT) were not found considering survival (RR 0.76, 95%CI 0.45-1.28) and complications (RR 0.68, 95% CI 0.4-1.10) at 12 months. No statistically significant difference was found between hospital readmissions and quality of life changes.
CONCLUSION


The statistical uncertainty of risk reduction of negative outcomes and the large variability of the collected data indicate the need of further research in large sample sizes. To enable future health economic evaluation for decision support surrounding implementation of GDT, we suggest adding patient-oriented outcomes in future trials.",2019,"Statistically significant differences (GDT vs RFT) were not found considering survival (RR 0.76, 95%CI 0.45-1.28) and complications (RR 0.68, 95% CI 0.4-1.10) at 12 months.","['elderly with hip-fracture', 'elderly with hip fracture', 'Patients with hip fracture (age ≥70']",['GDT or routine fluid treatment (RFT'],"['survival', 'clinical effectiveness, quality of life changes and costs', 'long-term survival, complications, number of hospital readmissions, and quality of life (EQ-5D) changes', 'complications', 'hospital readmissions and quality of life changes', 'cost effectiveness', 'cost-effectiveness']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0034380'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",75.0,0.229812,"Statistically significant differences (GDT vs RFT) were not found considering survival (RR 0.76, 95%CI 0.45-1.28) and complications (RR 0.68, 95% CI 0.4-1.10) at 12 months.","[{'ForeName': 'Erzsebet', 'Initials': 'E', 'LastName': 'Bartha', 'Affiliation': 'Perioperative Medicine and Intensive Care, Karolinska University Hospital, Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Davidson', 'Affiliation': 'Centre for Medical Technology Assessment, Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Hans E', 'Initials': 'HE', 'LastName': 'Berg', 'Affiliation': 'Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Sigridur', 'Initials': 'S', 'LastName': 'Kalman', 'Affiliation': 'Perioperative Medicine and Intensive Care, Karolinska University Hospital, Huddinge, Stockholm, Sweden.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13320']
1799,31678452,Prospective Study on the Efficacy of Orally Administered Tranexamic Acid and Goreisan for the Prevention of Recurrence After Chronic Subdural Hematoma Burr Hole Surgery.,"OBJECTIVE


This prospective study investigated whether tranexamic acid and Goreisan effectively prevent recurrence after burr hole surgery for chronic subdural hematoma.
METHODS


A total of 297 patients with chronic subdural hematoma underwent initial burr hole surgery at our hospital from April 2014 to March 2018. Of these, 206 patients (250 hematomas) consented to participate in this study. Patients were randomly divided into the nonadministration, tranexamic acid, and Goreisan groups based on age. The oral administration intervention was implemented from the day after surgery, after which there was a 3-month follow-up. Recurrence rates were measured, and head computed tomography scan was used to measure the volume of residual hematoma 1 day, 1 week, and 1, 2, and 3 months after surgery.
RESULTS


A total of 193 patients (232 hematomas) were followed-up for 3 months (82 hematomas in the nonadministration group, 72 hematomas in the tranexamic acid group, and 78 hematomas in the Goreisan group). There were no significant between-group differences in demographic characteristics, current drug treatment, comorbidities, hematoma, operation side (bilateral or unilateral), preoperative hematoma volume, and recurrence rates. At 1, 2, and 3 months, the residual hematoma volume was significantly smaller in the tranexamic acid group than in the other 2 groups.
CONCLUSIONS


Oral administration of tranexamic acid or Goreisan does not minimize recurrence after chronic subdural hematoma burr hole surgery; however, tranexamic acid can reduce the hematoma volume.",2020,"At 1, 2, and 3 months, the residual hematoma volume was significantly smaller in the tranexamic acid group than in the other two groups.
","['chronic subdural hematoma burr-hole surgery', '206 patients (250 hematomas) consented to participate in this study', '297 patients with chronic subdural hematoma underwent initial burr-hole surgery at our hospital from April 2014 to March 2018', '193 patients (232 hematomas']","['tranexamic acid', 'tranexamic acid or Goreisan', 'tranexamic acid, and Goreisan groupson', 'tranexamic acid and Goreisan']","['residual hematoma volume', 'demographic characteristics, current drug treatment, comorbidities, hematoma, operation side (bilateral or unilateral), preoperative hematoma volume, and recurrence rates', 'Recurrence rates']","[{'cui': 'C0749095', 'cui_str': 'Hemorrhage, Subdural, Chronic'}, {'cui': 'C0040836', 'cui_str': 'Trepanning'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",206.0,0.0316321,"At 1, 2, and 3 months, the residual hematoma volume was significantly smaller in the tranexamic acid group than in the other two groups.
","[{'ForeName': 'Tetsuhisa', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Emergency Medicine, Iizuka Hospital, Fukuoka, Japan. Electronic address: tyamadah4@aih-net.com.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Natori', 'Affiliation': 'Department of Neurosurgery, Iizuka Hospital, Fukuoka, Japan.'}]",World neurosurgery,['10.1016/j.wneu.2019.10.134']
1800,31525581,Transcranial direct current stimulation in patients with obsessive compulsive disorder: A randomized controlled trial.,"BACKGROUND


Obsessive-compulsive disorder (OCD) is a severe mental disorder with poor response to the available treatments. Neuroimaging studies have identified dysfunctions within the orbito-fronto-striato-pallido-thalamic network in patients with OCD. Here, we assessed the efficacy and safety of transcranial direct current stimulation (tDCS) applied with the cathode over the orbitofrontal cortex (OFC) and the anode over the right cerebellum to decrease OCD symptoms in patients with treatment-resistant OCD.
METHODS


In a randomized sham-controlled double-blind study, 21 patients with OCD were assigned to receive ten 20-min sessions (two sessions per day) of either active (2 mA) or sham tDCS. The clinical symptoms were measured using the Yale-Brown Obsessive and Compulsive Scale (YBOCS). Acute effects on the symptoms were measured from baseline to immediately after the 10 tDCS sessions. Long-lasting effects were measured 1 and 3 months after the 10th tDCS session.
RESULTS


Compared with the sham tDCS, active tDCS significantly decreased OCD symptoms immediately after the 10th tDCS session (F (1,19)  = 5.26, p = 0.03). However, no significant differences were observed between the active and sham groups in terms of changes in YBOCS score or the number of responders one and 3 months after tDCS.
CONCLUSION


Despite significant acute effects, tDCS with the cathode placed over the left OFC and the anode placed over the right cerebellum was not significantly effective in inducing a long-lasting reduction of symptoms in patients with treatment-resistant OCD.",2019,"However, no significant differences were observed between the active and sham groups in terms of changes in YBOCS score or the number of responders one and 3 months after tDCS.
","['patients with OCD', 'patients with obsessive compulsive disorder', 'patients with treatment-resistant OCD', '21 patients with OCD']","['transcranial direct current stimulation (tDCS', 'Transcranial direct current stimulation', 'active (2\u202fmA) or sham tDCS']","['YBOCS score', 'Yale-Brown Obsessive and Compulsive Scale (YBOCS', 'efficacy and safety', 'OCD symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.203964,"However, no significant differences were observed between the active and sham groups in terms of changes in YBOCS score or the number of responders one and 3 months after tDCS.
","[{'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Bation', 'Affiliation': 'INSERM U1028, CNRS UMR5292, PSYR2 Team, Lyon Neuroscience Research Center, Université Claude Bernard Lyon 1, Lyon, France; Centre Hospitalier Le Vinatier, Bron, France; Psychiatric Unit, Wertheimer Neurologic Hospital, CHU Lyon, F69500, Bron, France. Electronic address: remy.bation@chu-lyon.fr.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Mondino', 'Affiliation': 'INSERM U1028, CNRS UMR5292, PSYR2 Team, Lyon Neuroscience Research Center, Université Claude Bernard Lyon 1, Lyon, France; Centre Hospitalier Le Vinatier, Bron, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Le Camus', 'Affiliation': 'INSERM U1028, CNRS UMR5292, PSYR2 Team, Lyon Neuroscience Research Center, Université Claude Bernard Lyon 1, Lyon, France; Centre Hospitalier Le Vinatier, Bron, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Saoud', 'Affiliation': 'INSERM U1028, CNRS UMR5292, PSYR2 Team, Lyon Neuroscience Research Center, Université Claude Bernard Lyon 1, Lyon, France; Centre Hospitalier Le Vinatier, Bron, France; Psychiatric Unit, Wertheimer Neurologic Hospital, CHU Lyon, F69500, Bron, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Brunelin', 'Affiliation': 'INSERM U1028, CNRS UMR5292, PSYR2 Team, Lyon Neuroscience Research Center, Université Claude Bernard Lyon 1, Lyon, France; Centre Hospitalier Le Vinatier, Bron, France.'}]",European psychiatry : the journal of the Association of European Psychiatrists,['10.1016/j.eurpsy.2019.08.011']
1801,29874528,A Placebo-Controlled Trial of Bezafibrate in Primary Biliary Cholangitis.,"BACKGROUND


Patients with primary biliary cholangitis who have an inadequate response to therapy with ursodeoxycholic acid are at high risk for disease progression. Fibrates, which are agonists of peroxisome proliferator-activated receptors, in combination with ursodeoxycholic acid, have shown potential benefit in patients with this condition.
METHODS


In this 24-month, double-blind, placebo-controlled, phase 3 trial, we randomly assigned 100 patients who had had an inadequate response to ursodeoxycholic acid according to the Paris 2 criteria to receive bezafibrate at a daily dose of 400 mg (50 patients), or placebo (50 patients), in addition to continued treatment with ursodeoxycholic acid. The primary outcome was a complete biochemical response, which was defined as normal levels of total bilirubin, alkaline phosphatase, aminotransferases, and albumin, as well as a normal prothrombin index (a derived measure of prothrombin time), at 24 months.
RESULTS


The primary outcome occurred in 31% of the patients assigned to bezafibrate and in 0% assigned to placebo (difference, 31 percentage points; 95% confidence interval, 10 to 50; P<0.001). Normal levels of alkaline phosphatase were observed in 67% of the patients in the bezafibrate group and in 2% in the placebo group. Results regarding changes in pruritus, fatigue, and noninvasive measures of liver fibrosis, including liver stiffness and Enhanced Liver Fibrosis score, were consistent with the results of the primary outcome. Two patients in each group had complications from end-stage liver disease. The creatinine level increased 5% from baseline in the bezafibrate group and decreased 3% in the placebo group. Myalgia occurred in 20% of the patients in the bezafibrate group and in 10% in the placebo group.
CONCLUSIONS


Among patients with primary biliary cholangitis who had had an inadequate response to ursodeoxycholic acid alone, treatment with bezafibrate in addition to ursodeoxycholic acid resulted in a rate of complete biochemical response that was significantly higher than the rate with placebo and ursodeoxycholic acid therapy. (Funded by Programme Hospitalier de Recherche Clinique and Arrow Génériques; BEZURSO ClinicalTrials.gov number, NCT01654731 .).",2018,The creatinine level increased 5% from baseline in the bezafibrate group and decreased 3% in the placebo group.,"['100 patients who had had an inadequate response to ursodeoxycholic acid according to the Paris 2 criteria to receive', 'Primary Biliary Cholangitis', 'Patients with primary biliary cholangitis who have an inadequate response to therapy with', 'patients with primary biliary cholangitis', 'patients with this condition']","['placebo', 'Placebo', 'Bezafibrate', 'ursodeoxycholic acid therapy', 'ursodeoxycholic acid', 'bezafibrate']","['pruritus, fatigue, and noninvasive measures of liver fibrosis, including liver stiffness and Enhanced Liver Fibrosis score', 'complete biochemical response', 'Myalgia', 'rate of complete biochemical response', 'creatinine level', 'normal levels of total bilirubin, alkaline phosphatase, aminotransferases, and albumin, as well as a normal prothrombin index (a derived measure of prothrombin time', 'Normal levels of alkaline phosphatase']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C0331677', 'cui_str': 'Paris (organism)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008312', 'cui_str': 'Primary Billiary Cholangitis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005330', 'cui_str': 'Bezafibrate'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1285893', 'cui_str': 'Measure of liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0033706', 'cui_str': 'coagulation factor II'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin Time'}]",100.0,0.677141,The creatinine level increased 5% from baseline in the bezafibrate group and decreased 3% in the placebo group.,"[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Corpechot', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chazouillères', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rousseau', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Le Gruyer', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Habersetzer', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Mathurin', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Goria', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Potier', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Minello', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Silvain', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Armand', 'Initials': 'A', 'LastName': 'Abergel', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Maryline', 'Initials': 'M', 'LastName': 'Debette-Gratien', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Larrey', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Roux', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bronowicki', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Boursier', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'de Ledinghen', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Heurgue-Berlot', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Nguyen-Khac', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Zoulim', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ollivier-Hourmand', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Zarski', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Gisèle', 'Initials': 'G', 'LastName': 'Nkontchou', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lemoinne', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Lydie', 'Initials': 'L', 'LastName': 'Humbert', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Rainteau', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lefèvre', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'de Chaisemartin', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chollet-Martin', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Gaouar', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Farid-Hakeem', 'Initials': 'FH', 'LastName': 'Admane', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Tabassome', 'Initials': 'T', 'LastName': 'Simon', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Poupon', 'Affiliation': ""From the Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hôpitaux de Paris (APHP) (C.C., O.C., S.L., F.G., R.P.), INSERM Unité Mixte de Recherche (UMR) S938 (C.C., O.C., S.L., R.P.) and the Biochemistry Laboratory (L.H., D.R.), Saint-Antoine University Hospital, APHP, INSERM Unité 1157/UMR 7203, Sorbonne University, the Biochemistry Laboratory, Tenon University Hospital, APHP (G.L.), and the Immunology Laboratory, INSERM UMR S996, Bichat University Hospital, APHP (L.C., S.C.-M.), Paris-Sud University, the Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris, APHP (A.R., F.-H.A., T.S.), and Sorbonne University (T.S.), Paris, the Hepatology and Gastroenterology Department, Rouen University Hospital, Rouen (O.G.), the Hepatology and Gastroenterology Department, Pontchaillou University Hospital, Rennes (A.L.G.), the Hepatology and Gastroenterology Department, University Hospitals of Strasbourg, Institute of Viral and Liver Diseases, INSERM Unité 1110, Laboratory of Excellence HepSYS, University of Strasbourg, Strasbourg (F.H.), the Hepatology and Gastroenterology Department, Claude Huriez University Hospital, Lille (P.M.), the Hepatology and Gastroenterology Department, Orleans Hospital, Orleans (P.P.), the Hepatology and Gastroenterology Department, Dijon Bourgogne University Hospital, Dijon (A.M.), the Hepatology and Gastroenterology Department, University Hospital of Poitiers, Poitiers (C.S.), the Hepatology and Gastroenterology Department, Estaing University Hospital, Clermont-Ferrand (A.A.), the Hepatology and Gastroenterology Department, University Hospital of Limoges, Limoges (M.D.-G.), the Hepatology and Gastroenterology Department, Saint-Eloi University Hospital, Montpellier (D.L.), the Hepatology Department, Beaujon University Hospital, Clichy (O.R.), the Hepatology and Gastroenterology Department, Brabois University Hospital, Nancy (J.-P.B.), the Hepatology and Gastroenterology Department, University Hospital of Angers, Hemodynamics, Interaction, Fibrosis, and Tumor Invasiveness in Hepatic and Digestive Organs Laboratory, Unité Propre de Recherche de l'Enseignement Supérieur 3859, Structures Fédératives de Recherche 4208, Bretagne Loire University, Angers (J.B.), the Hepatology and Gastroenterology Department, Haut-Lévêque University Hospital, Pessac (V.L.), the Hepatology and Gastroenterology Department, Robert Debré University Hospital, Reims (A.H.-B.), the Hepatology and Gastroenterology Department, University Hospital of Amiens, Amiens (E.N.-K.), the Hepatology and Gastroenterology Department, Croix-Rousse University Hospital, Lyon (F.Z.), the Hepatology and Gastroenterology Department, University Hospital of Caen, Caen (I.O.-H.), the Hepatology and Gastroenterology Department, Michallon University Hospital, Grenoble (J.-P.Z.), and the Hepatology and Gastroenterology Department, Jean Verdier University Hospital, Bondy (G.N.) - all in France.""}]",The New England journal of medicine,['10.1056/NEJMoa1714519']
1802,30631161,Mineralocorticoid receptor blockade suppresses dietary salt-induced ACEI/ARB-resistant albuminuria in non-diabetic hypertension: a sub-analysis of evaluate study.,"Excessive dietary salt intake can counteract the renoprotective effects of renin-angiotensin system (RAS) blockade in hypertensive patients with chronic kidney disease (CKD). In rodents, salt loading induces hypertension and renal damage by activating the mineralocorticoid receptor (MR) independently of plasma aldosterone levels. Thus, high salt-induced resistance to RAS blockade may be mediated by MR activation. To test this, a post hoc analysis of the Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect (EVALUATE) trial was conducted. Thus, 304 non-diabetic hypertensive patients on RAS-blocking therapy were divided into tertiles according to salt intake (estimated 24-h urinary sodium excretion at baseline) and compared in terms of percent reduction in urinary albumin-to-creatinine ratio (UACR) at 52 weeks relative to baseline. The eplerenone-treated patients in the highest sodium excretion tertile exhibited significantly greater reduction in UACR than the placebo subjects in the same tertile (-22.5% vs. +21.8%, p = 0.02). This disparity was not observed in the lowest (-10.2% vs. -0.84%, p = 0.65) or middle (-19.5% vs. +9.5%, p = 0.22) tertiles. Similar systolic blood pressure changes were observed. In the whole cohort, reduction in UACR correlated positively with reduction in systolic blood pressure (r 2  = 0.04, p = 0.02). These results support the hypothesis that excessive salt intake can enhance resistance to RAS blockade by activating MR. They also suggest that eplerenone plus RAS blockade may be effective for CKD in hypertensive patients, especially those with excessive salt intake.",2019,Excessive dietary salt intake can counteract the renoprotective effects of renin-angiotensin system (RAS) blockade in hypertensive patients with chronic kidney disease (CKD).,"['304 non-diabetic hypertensive patients on RAS-blocking therapy', 'hypertensive patients', 'hypertensive patients with chronic kidney disease (CKD', 'non-diabetic hypertension']","['renin-angiotensin system (RAS) blockade', 'Eplerenone Combination Versus Conventional Agents', 'eplerenone plus RAS blockade', 'placebo']","['systolic blood pressure', 'urinary albumin-to-creatinine ratio (UACR', 'Similar systolic blood pressure changes', 'UACR']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0035096'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",304.0,0.0313878,Excessive dietary salt intake can counteract the renoprotective effects of renin-angiotensin system (RAS) blockade in hypertensive patients with chronic kidney disease (CKD).,"[{'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Nishimoto', 'Affiliation': 'Division of Clinical Epigenetics, Research Center of Advanced Science and Technology, The University of Tokyo, Tokyo, Japan. nishimoto-tky@umin.ac.jp.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ohtsu', 'Affiliation': 'Clinical Epidemiology Section, Department of Clinical Study and Informatics, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Marumo', 'Affiliation': 'Division of Clinical Epigenetics, Research Center of Advanced Science and Technology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Wakako', 'Initials': 'W', 'LastName': 'Kawarazaki', 'Affiliation': 'Division of Clinical Epigenetics, Research Center of Advanced Science and Technology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Ayuzawa', 'Affiliation': 'Division of Clinical Epigenetics, Research Center of Advanced Science and Technology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Ueda', 'Affiliation': 'Division of Clinical Epigenetics, Research Center of Advanced Science and Technology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Daigoro', 'Initials': 'D', 'LastName': 'Hirohama', 'Affiliation': 'Division of Clinical Epigenetics, Research Center of Advanced Science and Technology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Fumiko', 'Initials': 'F', 'LastName': 'Kawakami-Mori', 'Affiliation': 'Division of Clinical Epigenetics, Research Center of Advanced Science and Technology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Nagase', 'Affiliation': 'Department of Anatomy, Kyorin University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Isshiki', 'Affiliation': 'Department of Endocrinology and Diabetes, School of Medicine, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Shigeyoshi', 'Initials': 'S', 'LastName': 'Oba', 'Affiliation': 'Division of Clinical Epigenetics, Research Center of Advanced Science and Technology, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Shimosawa', 'Affiliation': 'Department of Clinical Laboratory, School of Medicine, International University of Health and Welfare, Otawara, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Division of Clinical Epigenetics, Research Center of Advanced Science and Technology, The University of Tokyo, Tokyo, Japan. Toshiro.FUJITA@rcast.u-tokyo.ac.jp.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-018-0201-7']
1803,30529393,"Auricular acupuncture as an adjunct for pain management during first trimester abortion: a randomized, double-blinded, three arm trial.","OBJECTIVES


To assess pain-management using auricular acupuncture as an adjunct to ibuprofen and paracervical block during first trimester uterine aspiration, and to assess auricular acupuncture's effect on anxiety.
STUDY DESIGN


This randomized, double-blinded, three-arm trial enrolled women undergoing uterine aspiration for spontaneous or induced abortion. Study participants were randomized 1:1:1 to receive auricular acupuncture, placebo, or usual care alone. Participants in all groups received ibuprofen and paracervical block (usual care). The main outcome was maximum pain reported at the end of the procedure measured using a Visual Analog Scale; we compared those receiving auricular acupuncture to those receiving usual care alone. We also compared auricular acupuncture to placebo and placebo to usual care alone. Finally, we compared the maximum anxiety scores between participants randomized to auricular acupuncture, placebo, and usual care alone.
RESULTS


We randomized 153 women over 9 months, and analyzed 52 participants in the auricular acupuncture group, 49 in the placebo group, and 49 in the usual care group. The groups had similar baseline characteristics. After uterine aspiration, participants reported median maximum pain scores as follows: auricular acupuncture 39.5 (interquartile range (IQR) 11, 64.5), placebo 70.0 (IQR 40.5, 84), and usual care alone 71.0 (IQR 32, 91.5) (p<0.01). In pairwise comparisons, the median maximum pain score after auricular acupuncture was lower than placebo and usual-care groups (p<0.01 for both). Post-procedure median anxiety scores were 11.5, 31.0 and 44.0, respectively (p=.01).
CONCLUSIONS


Women undergoing first trimester uterine aspiration assigned to auricular acupuncture reported substantially less pain and anxiety than women assigned to placebo or usual care.
IMPLICATIONS


Auricular acupuncture may be a useful adjunct to ibuprofen and paracervical block during first trimester uterine aspiration. This approach to managing pain and anxiety could avoid the operational complexities and expenses of sedation and opioid use.",2019,"CONCLUSIONS


Women undergoing first trimester uterine aspiration assigned to auricular acupuncture reported substantially less pain and anxiety than women assigned to placebo or usual care.
","['enrolled women undergoing uterine aspiration for spontaneous or induced abortion', 'Women undergoing first trimester uterine aspiration assigned to', '153 women over 9 months, and analyzed 52 participants in the auricular acupuncture group, 49 in the placebo group, and 49 in the usual care group', 'pain management during first trimester abortion']","['auricular acupuncture', 'placebo', 'ibuprofen', 'placebo and placebo', 'Auricular acupuncture', 'auricular acupuncture, placebo, and usual care alone', 'auricular acupuncture, placebo, or usual care alone', 'ibuprofen and paracervical block (usual care', 'ibuprofen and paracervical block']","['maximum pain', 'maximum anxiety scores', 'Post-procedure median anxiety scores', 'median maximum pain scores', 'Visual Analog Scale', 'pain and anxiety', 'median maximum pain score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0032979', 'cui_str': 'Early Placental Phase'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0752217', 'cui_str': 'Auricular Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]","[{'cui': 'C0752217', 'cui_str': 'Auricular Acupuncture'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0030401', 'cui_str': 'Paracervical Block'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",153.0,0.77415,"CONCLUSIONS


Women undergoing first trimester uterine aspiration assigned to auricular acupuncture reported substantially less pain and anxiety than women assigned to placebo or usual care.
","[{'ForeName': 'Chioma', 'Initials': 'C', 'LastName': 'Ndubisi', 'Affiliation': 'Dept. of Obstetrics and Gynecology, Columbia University Irving Medical Center (CUIMC), NY, NY.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Danvers', 'Affiliation': 'Dept. of Obstetrics and Gynecology, Columbia University Irving Medical Center (CUIMC), NY, NY.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Gold', 'Affiliation': 'Dept. of Pediatrics, CUIMC; Heilbrunn Dept. of Population & Family Health, Mailman School of Public Health, CUIMC.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Morrow', 'Affiliation': 'Montefiore Medical Group, Bronx, NY 10458.'}, {'ForeName': 'Carolyn L', 'Initials': 'CL', 'LastName': 'Westhoff', 'Affiliation': 'Dept. of Obstetrics and Gynecology, Columbia University Irving Medical Center (CUIMC), NY, NY; Heilbrunn Dept. of Population & Family Health, Mailman School of Public Health, CUIMC. Electronic address: clw3@columbia.edu.'}]",Contraception,['10.1016/j.contraception.2018.11.016']
1804,30638856,"Efficacy and safety of burosumab in children aged 1-4 years with X-linked hypophosphataemia: a multicentre, open-label, phase 2 trial.","BACKGROUND


Children with X-linked hypophosphataemia have high concentrations of circulating phosphatonin fibroblast growth factor 23 (FGF23), which causes renal phosphate wasting and hypophosphataemia, rickets, skeletal deformities, and growth impairment. Burosumab, a human monoclonal antibody against FGF23, improves phosphate homoeostasis and rickets in children aged 5-12 years with X-linked hypophosphataemia. We aimed to assess the safety and efficacy of burosumab in younger children with X-linked hypophosphataemia.
METHODS


In this open-label, phase 2 trial at three hospitals in the USA, children (aged 1-4 years) with X-linked hypophosphataemia received burosumab (0·8 mg/kg) via subcutaneous injection every 2 weeks for 64 weeks. The dose was increased to 1·2 mg/kg if two consecutive pre-dose serum phosphorus concentrations were below 1·03 mmol/L (3·2 mg/dL), serum phosphorus had increased by less than 0·16 mmol/L (<0·5 mg/dL) from baseline, and a dose of burosumab had not been missed. Participants could continue to receive burosumab for up to an additional 96 weeks during the extension period. Key inclusion criteria were age 1-4 years at the time of informed consent; fasting serum phosphorus concentration of less than 0·97 mmol/L (3·0 mg/dL); serum creatinine 8·8-35·4 μmol/L (0·1-0·4 mg/dL); radiographic evidence of rickets (at least five participants were required to have a Thacher Rickets Severity Score of ≥1·5 at the knee); and a confirmed PHEX mutation or a variant of unknown significance in the patient or direct relative also affected with X-linked hypophosphataemia. Conventional therapy was stopped upon enrolment. The coprimary endpoints were safety and change from baseline to week 40 in fasting serum phosphorus concentrations. Changes in rickets severity from baseline to weeks 40 and 64 (assessed radiographically using Thacher Rickets Severity Score and an adaptation of the Radiographic Global Impression of Change), and recumbent length or standing height, were key secondary outcomes. This trial is registered with ClinicalTrials.gov, number NCT02750618, and is ongoing.
FINDINGS


Between May 16, 2016, and June 10, 2016, we enrolled 13 children with X-linked hypophosphataemia. All 13 children completed 64 weeks of treatment and were included in the efficacy and safety analysis; none exceeded 70 weeks of treatment at the time of analysis. Serum phosphorus least squares mean increase from baseline to week 40 of treatment was 0·31 mmol/L (SE 0·04; 95% CI 0·24-0·39; 0·96 mg/dL [SE 0·12]; p<0·0001). All patients had at least one adverse event. 14 treatment-related adverse events, mostly injection site reactions, occurred in five children. One serious adverse event considered unrelated to treatment (tooth abscess) occurred in a child with a history of tooth abscess. All other adverse events were mild to moderate, except a severe food allergy considered unrelated to treatment. No instances of nephrocalcinosis or noteworthy changes in the results of a standard safety chemistry panel emerged. Total Thacher Rickets Severity Score decreased by a least squares mean of -1·7 (SE 0·1; p<0·0001) from baseline to week 40 and by -2·0 (SE 0·1; p<0·0001) by week 64. The Radiographic Global Impression of Change score also indicated significant improvement, with a least squares mean score of +2·3 (SE 0·1) at week 40 and +2·2 (0·1) at week 64 (both p<0·0001). Mean length or standing height Z score was maintained from baseline to week 64.
INTERPRETATION


Burosumab had a favourable safety profile, increased serum phosphorus, and improved rickets and prevented early declines in growth in children aged 1-4 years with X-linked hypophosphataemia. These findings could substantially alter the treatment of young children with X-linked hypophosphataemia.
FUNDING


Ultragenyx Pharmaceutical and Kyowa Kirin International.",2019,Total Thacher Rickets Severity Score decreased by a least squares mean of -1·7 (SE 0·1; p<0·0001) from baseline to week 40 and by -2·0 (SE 0·1; p<0·0001) by week 64.,"['Key inclusion criteria were age 1-4 years at the time of informed consent; fasting serum phosphorus concentration of less than 0·97 mmol/L (3·0 mg/dL); serum creatinine 8·8-35·4 μmol/L (0·1-0·4 mg/dL); radiographic evidence of rickets (at least five participants were required to have a Thacher Rickets Severity Score of ≥1·5 at the knee); and a confirmed PHEX mutation or a variant of unknown significance in the patient or direct relative also affected with X-linked hypophosphataemia', 'children aged 5-12 years with X-linked hypophosphataemia', 'children aged 1-4 years with X-linked hypophosphataemia', 'young children with X-linked hypophosphataemia', 'Between May 16, 2016, and June 10, 2016, we enrolled 13 children with X-linked hypophosphataemia', 'younger children with X-linked hypophosphataemia', 'three hospitals in the USA, children (aged 1-4 years) with X-linked hypophosphataemia received']","['Conventional therapy', 'burosumab (0·8 mg/kg) via subcutaneous injection']","['safety and efficacy', 'rickets severity', 'Total Thacher Rickets Severity Score', 'serum phosphorus', 'adverse events, mostly injection site reactions', 'safety and change from baseline to week 40 in fasting serum phosphorus concentrations', 'Mean length or standing height Z score', 'Radiographic Global Impression of Change score', 'Efficacy and safety', 'phosphate homoeostasis and rickets', 'Thacher Rickets Severity Score and an adaptation of the Radiographic Global Impression of Change), and recumbent length or standing height', 'serum phosphorus concentrations', 'Serum phosphorus least squares mean increase']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0035579', 'cui_str': 'Rachitis'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C3540852', 'cui_str': 'Hypophosphatemia, X-Linked'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4301607', 'cui_str': 'burosumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035579', 'cui_str': 'Rachitis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0424645', 'cui_str': 'Standing height (observable entity)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",13.0,0.0772633,Total Thacher Rickets Severity Score decreased by a least squares mean of -1·7 (SE 0·1; p<0·0001) from baseline to week 40 and by -2·0 (SE 0·1; p<0·0001) by week 64.,"[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Whyte', 'Affiliation': 'Shriners Hospital for Children, St Louis, MO, USA. Electronic address: mwhyte@shrinenet.org.'}, {'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Carpenter', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Gottesman', 'Affiliation': 'Shriners Hospital for Children, St Louis, MO, USA.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Mao', 'Affiliation': 'Ultragenyx Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Skrinar', 'Affiliation': 'Ultragenyx Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'San Martin', 'Affiliation': 'Ultragenyx Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Imel', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(18)30338-3']
1805,30633084,"Physical Activity, Depression, and Antiretroviral Therapy Adherence Among People Living With HIV: A Mediation Analysis.","The aim of our study was to explore the relationships between physical activity, depression, and antiretroviral therapy (ART) adherence. Data were obtained from a randomized controlled trial of people living with HIV (N = 658) in China. Ordinal regression and logistic regression analyses were performed to examine associations between ART adherence, depression, and physical activity. A better ART adherence was associated with higher levels of physical activity (adjusted odds ratio [aOR] = 1.36, 95% confidence interval [CI] = 1.02-1.80) and lower levels of depression (aOR = 0.95, 95% CI = 0.92-0.99). Higher levels of physical activity were also associated with lower levels of depression (aOR = 0.50, 95% CI = 0.32-0.76). Sobel Z test indicated the mediating effect of depression between physical activity and ART adherence (Sobel Z = 1.96, p < .05). This study suggests the benefit of appropriate levels of physical activity to promote both psychological health and ART adherence in people living with HIV.",2019,"A better ART adherence was associated with higher levels of physical activity (adjusted odds ratio [aOR] = 1.36, 95% confidence interval [CI] = 1.02-1.80) and lower levels of depression (aOR = 0.95, 95% CI = 0.92-0.99).","['People Living With HIV', 'people living with HIV (N = 658) in China', 'people living with HIV']",[],"['Physical Activity, Depression, and Antiretroviral Therapy', 'levels of depression', 'physical activity, depression, and antiretroviral therapy (ART) adherence', 'ART adherence, depression, and physical activity', 'physical activity and ART adherence', 'physical activity', 'Higher levels of physical activity']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",658.0,0.218956,"A better ART adherence was associated with higher levels of physical activity (adjusted odds ratio [aOR] = 1.36, 95% confidence interval [CI] = 1.02-1.80) and lower levels of depression (aOR = 0.95, 95% CI = 0.92-0.99).","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Bhochhibhoya', 'Affiliation': ''}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': ''}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': ''}, {'ForeName': 'Yuejiao', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Sui', 'Affiliation': ''}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}]",The Journal of the Association of Nurses in AIDS Care : JANAC,['10.1097/JNC.0000000000000045']
1806,31843639,"Rationale, design, and development of SleepWell24: A smartphone application to promote adherence to positive airway pressure therapy among patients with obstructive sleep apnea.","BACKGROUND


Positive airway pressure (PAP) therapy is the gold standard treatment for obstructive sleep apnea (OSA), a chronic disorder that affects 6-13% of the adult population. However, adherence to PAP therapy is challenging, and current approaches to improve adherence have limited efficacy and scalability.
METHODS/DESIGN


To promote PAP adherence, we developed SleepWell24, a multicomponent, evidence-based smartphone application that delivers objective biofeedback concerning PAP use and sleep/physical activity patterns via cloud-based PAP machine and wearable sensor data, and behavior change strategies and troubleshooting of PAP therapy interface use. This randomized controlled trial will evaluate the feasibility, acceptability, and initial efficacy of SleepWell24 compared to a usual care control condition during the first 60 days of PAP therapy among patients newly diagnosed with OSA.
DISCUSSION


SleepWell24 is an innovative, multi-component behavior change intervention, designed as a self-management approach to addressing the psychosocial determinants of adherence to PAP therapy among new users. The results will guide lengthier future trials that assess numerous patient-centered and clinical outcomes.",2020,"This randomized controlled trial will evaluate the feasibility, acceptability, and initial efficacy of SleepWell24 compared to a usual care control condition during the first 60 days of PAP therapy among patients newly diagnosed with OSA.
","['patients with obstructive sleep apnea', 'SleepWell24', 'patients newly diagnosed with OSA', 'obstructive sleep apnea (OSA']","['PAP therapy', 'Positive airway pressure (PAP) therapy', 'smartphone application']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",[],,0.033392,"This randomized controlled trial will evaluate the feasibility, acceptability, and initial efficacy of SleepWell24 compared to a usual care control condition during the first 60 days of PAP therapy among patients newly diagnosed with OSA.
","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Petrov', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, United States of America. Electronic address: Petrov@asu.edu.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Hasanaj', 'Affiliation': 'College of Health Solutions, Arizona State University, United States of America.'}, {'ForeName': 'Coles M', 'Initials': 'CM', 'LastName': 'Hoffmann', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, United States of America.'}, {'ForeName': 'Dana R', 'Initials': 'DR', 'LastName': 'Epstein', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, United States of America; College of Health Solutions, Arizona State University, United States of America.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Krahn', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Scottsdale, AZ, United States of America.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Park', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Rochester, MN, United States of America.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Hollingshead', 'Affiliation': 'College of Health Solutions, Arizona State University, United States of America.'}, {'ForeName': 'Tsung-Yen', 'Initials': 'TY', 'LastName': 'Yu', 'Affiliation': 'College of Health Solutions, Arizona State University, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, United States of America.'}, {'ForeName': 'Erik K', 'Initials': 'EK', 'LastName': 'St Louis', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Rochester, MN, United States of America.'}, {'ForeName': 'Timothy I', 'Initials': 'TI', 'LastName': 'Morgenthaler', 'Affiliation': 'Center for Sleep Medicine, Mayo Clinic, Rochester, MN, United States of America.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Buman', 'Affiliation': 'College of Health Solutions, Arizona State University, United States of America. Electronic address: Matthew.Buman@asu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105908']
1807,27405326,Non-randomized and randomized stepped-wedge designs using an orthogonalized least squares framework.,"Randomized stepped-wedge (R-SW) designs are increasingly used to evaluate interventions targeting continuous longitudinal outcomes measured at T-fixed time points. Typically, all units start out untreated, and randomly chosen units switch to intervention at sequential time points until all receive intervention. As randomization is not always feasible, non-randomized stepped-wedge (NR-SW) designs (units switching to intervention are not randomly chosen) have attracted researchers. We develop an orthogonlized generalized least squares framework for both R-SW and NR-SW designs. The variance of the intervention effect estimate depends on the number of steps ( S), length of step sizes ( t s ), and number of units ( n s ) switched at each step ( s=1,…, S). If all other design parameters are equal, this variance is higher for the NR-SW than for the equivalent R-SW design (particularly if the intercepts of non-randomly stepped switching strata are analyzed as fixed effects). We focus on balanced stepped-wedge (BR-SW, BNR-SW) designs (where t s  and n s  remain constant across s) to obtain insights into optimality for variance of the estimated intervention effect. As previously observed for the BR-SW, the optimal choice for number of time points at each step is also [Formula: see text] for the BNR-SW. In our examples, when compared to BR-SW designs, equivalent BNR-SW designs even with intercepts of non-randomly stepped switching strata analyzed using fixed effects sacrifice little efficiency given an intra-unit repeated measure correlation [Formula: see text]. Compared to traditional difference-in-differences designs, optimal BNR-SW designs are more efficient with the ratio of variances of these designs converging to 0.75 when T > 10. We illustrate these findings using longitudinal outcomes in long-term care facilities.",2018,"If all other design parameters are equal, this variance is higher for the NR-SW than for the equivalent R-SW design (particularly if the intercepts of non-randomly stepped switching strata are analyzed as fixed effects).",[],['Randomized stepped-wedge (R-SW'],"['number of steps ( S), length of step sizes ( t s ), and number of units ( n s ']",[],"[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439639', 'cui_str': 'Wedge (physical object)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0449961', 'cui_str': 'Number of units (qualifier value)'}]",,0.0722309,"If all other design parameters are equal, this variance is higher for the NR-SW than for the equivalent R-SW design (particularly if the intercepts of non-randomly stepped switching strata are analyzed as fixed effects).","[{'ForeName': 'Yirui', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': '1 Department of Statistics and Biostatistics, Rutgers University New Brunswick, New Jersey, USA.'}, {'ForeName': 'Donald R', 'Initials': 'DR', 'LastName': 'Hoover', 'Affiliation': '1 Department of Statistics and Biostatistics, Rutgers University New Brunswick, New Jersey, USA.'}]",Statistical methods in medical research,['10.1177/0962280216657852']
1808,29349922,Association between breast milk intake at 9-10 months of age and growth and development among Malawian young children.,"World Health Organization recommends exclusive breastfeeding for infants for the first 6 months of life, followed by introduction of nutritious complementary foods alongside breastfeeding. Breast milk remains a significant source of nourishment in the second half of infancy and beyond; however, it is not clear whether more breast milk is always better. The present study was designed to determine the association between amount of breast milk intake at 9-10 months of age and infant growth and development by 12-18 months of age. The study was nested in a randomized controlled trial conducted in Malawi. Regression analysis was used to determine associations between breast milk intake and growth and development. Mean (SD) breast milk intake at 9-10 months of age was 752 (244) g/day. Mean (SD) length-for-age z-score at 12 months and change in length-for-age z-score between 12 and 18 months were -1.69 (1.0) and -0.17 (0.6), respectively. At 18 months, mean (SD) expressive vocabulary score was 32 (24) words and median (interquartile range) skills successfully performed for fine, gross, and overall motor skills were 21 (19-22), 18 (16-19), and 38 (26-40), respectively. Breast milk intake (g/day) was not associated with either growth or development. Proportion of total energy intake from breast milk was negatively associated with fine motor (β = -0.18, p = .015) but not other developmental scores in models adjusted for potential confounders. Among Malawian infants, neither breast milk intake nor percent of total energy intake from breast milk at 9-10 months was positively associated with subsequent growth between 12 and 18 months, or development at 18 months.",2018,Breast milk intake (g/day) was not associated with either growth or development.,"['breast milk intake at 9-10\xa0months of age and infant growth and development by 12-18\xa0months of age', 'Malawian young children']",[],"['Mean (SD) length-for-age z-score', 'Mean (SD) breast milk intake', 'total energy intake', 'overall motor skills', 'mean (SD) expressive vocabulary score']","[{'cui': 'C0556182', 'cui_str': 'Breast milk intake (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1457898', 'cui_str': 'growth & development'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0556182', 'cui_str': 'Breast milk intake (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0282597,Breast milk intake (g/day) was not associated with either growth or development.,"[{'ForeName': 'Chiza', 'Initials': 'C', 'LastName': 'Kumwenda', 'Affiliation': 'Centre for Child Health Research, University of Tampere and Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Jaimie', 'Initials': 'J', 'LastName': 'Hemsworth', 'Affiliation': 'Department of Population Health, Nutrition Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Phuka', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi, College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Centre for Child Health Research, University of Tampere and Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Arimond', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi, College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Prado', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Marjorie J', 'Initials': 'MJ', 'LastName': 'Haskell', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Centre for Child Health Research, University of Tampere and Tampere University Hospital, Tampere, Finland.'}]",Maternal & child nutrition,['10.1111/mcn.12582']
1809,31562043,"Vinorelbine and continuous low-dose cyclophosphamide as maintenance chemotherapy in patients with high-risk rhabdomyosarcoma (RMS 2005): a multicentre, open-label, randomised, phase 3 trial.","BACKGROUND


For more than three decades, standard treatment for rhabdomyosarcoma in Europe has included 6 months of chemotherapy. The European paediatric Soft tissue sarcoma Study Group (EpSSG) aimed to investigate whether prolonging treatment with maintenance chemotherapy would improve survival in patients with high-risk rhabdomyosarcoma.
METHODS


RMS 2005 was a multicentre, open-label, randomised, controlled, phase 3 trial done at 102 hospitals in 14 countries. We included patients aged 6 months to 21 years with rhabdomyosarcoma who were considered to be at high risk of relapse: those with non-metastatic incompletely resected embryonal rhabdomyosarcoma occurring at unfavourable sites with unfavourable age (≥10 years) or tumour size (>5 cm), or both; those with any non-metastatic rhabdomyosarcoma with nodal involvement; and those with non-metastatic alveolar rhabdomyosarcoma but without nodal involvement. Patients in remission after standard treatment (nine cycles of ifosfamide, vincristine, dactinomycin with or without doxorubicin, and surgery or radiotherapy, or both) were randomly assigned (1:1) to stop treatment or continue maintenance chemotherapy (six cycles of intravenous vinorelbine 25 mg/m 2  on days 1, 8, and 15, and daily oral cyclophosphamide 25 mg/m 2 , on days 1-28). Randomisation was done by use of a web-based system and was stratified (block size of four) by enrolling country and risk subgroup. Neither investigators nor patients were masked to treatment allocation. The primary outcome was disease-free survival in the intention-to-treat population. Secondary outcomes were overall survival and toxicity. This trial is registered with EudraCT, number 2005-000217-35, and ClinicalTrials.gov, number NCT00339118, and follow-up is ongoing.
FINDINGS


Between April 20, 2006, and Dec 21, 2016, 371 patients were enrolled and randomly assigned to the two groups: 186 to stop treatment and 185 to receive maintenance chemotherapy. Median follow-up was 60·3 months (IQR 32·4-89·4). In the intention-to-treat population, 5-year disease-free survival was 77·6% (95% CI 70·6-83·2) with maintenance chemotherapy versus 69·8% (62·2-76·2) without maintenance chemotherapy (hazard ratio [HR] 0·68 [95% CI 0·45-1·02]; p=0·061), and 5-year overall survival was 86·5% (95% CI 80·2-90·9) with maintenance chemotherapy versus 73·7% (65·8-80·1) without (HR 0·52 [95% CI 0·32-0·86]; p=0·0097). Toxicity was manageable in patients who received maintenance chemotherapy: 136 (75%) of 181 patients had grade 3-4 leucopenia, 148 (82%) had grade 3-4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection. One (1%) patient had a grade 4 non-haematological toxicity (neurotoxicity). Two treatment-related serious adverse events occurred: one case of inappropriate antidiuretic hormone secretion and one of a severe steppage gait with limb pain, both of which resolved.
INTERPRETATION


Adding maintenance chemotherapy seems to improve survival for patients with high-risk rhabdomyosarcoma. This approach will be the new standard of care for patients with high-risk rhabdomyosarcoma in future EpSSG trials.
FUNDING


Fondazione Città della Speranza, Association Léon Berard Enfant Cancéreux, Clinical Research Hospital Program (French Ministry of Health), and Cancer Research UK.",2019,"Toxicity was manageable in patients who received maintenance chemotherapy: 136 (75%) of 181 patients had grade 3-4 leucopenia, 148 (82%) had grade 3-4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection.","['Between April 20, 2006, and Dec 21, 2016, 371 patients were enrolled and randomly assigned to the two groups: 186 to stop treatment and 185 to receive', '102 hospitals in 14 countries', 'patients with high-risk rhabdomyosarcoma in future EpSSG trials', 'patients with high-risk rhabdomyosarcoma', 'patients with high-risk rhabdomyosarcoma (RMS 2005', 'patients aged 6 months to 21 years with rhabdomyosarcoma who were considered to be at high risk of relapse: those with non-metastatic incompletely resected embryonal rhabdomyosarcoma occurring at unfavourable sites with unfavourable age (≥10 years) or tumour size (>5 cm), or both; those with any non-metastatic rhabdomyosarcoma with nodal involvement; and those with non-metastatic alveolar rhabdomyosarcoma but without nodal involvement']","['Vinorelbine and continuous low-dose cyclophosphamide', 'cyclophosphamide', 'ifosfamide, vincristine, dactinomycin with or without doxorubicin, and surgery or radiotherapy, or both) were randomly assigned (1:1) to stop treatment or continue maintenance chemotherapy (six cycles of intravenous vinorelbine', 'maintenance chemotherapy']","['grade 4 non-haematological toxicity (neurotoxicity', 'survival', 'thrombocytopenia', 'overall survival and toxicity', 'anaemia', '5-year disease-free survival', 'Toxicity', 'grade 3-4 leucopenia', '5-year overall survival', 'grade 3-4 neutropenia', 'inappropriate antidiuretic hormone secretion and one of a severe steppage gait with limb pain, both of which resolved', 'disease-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0206656', 'cui_str': 'Embryonal Rhabdomyosarcoma'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0206655', 'cui_str': 'Rhabdomyosarcoma 2'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0021141', 'cui_str': 'Syndrome of Inappropriate ADH (SIADH) Secretion'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0427149', 'cui_str': 'Gait, Drop Foot'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb (finding)'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}]",371.0,0.370497,"Toxicity was manageable in patients who received maintenance chemotherapy: 136 (75%) of 181 patients had grade 3-4 leucopenia, 148 (82%) had grade 3-4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection.","[{'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Bisogno', 'Affiliation': ""Haematology Oncology Division, Department of Women's and Children's Health, University of Padova, Padova, Italy. Electronic address: gianni.bisogno@unipd.it.""}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'De Salvo', 'Affiliation': 'Clinical Research Unit, Istituto Oncologico Veneto IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Bergeron', 'Affiliation': ""Institut d'Hématologie et d'Oncologie Pédiatrique, Centre Léon Bérard, Lyon, France.""}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Gallego Melcón', 'Affiliation': ""Servicio de Oncología y Hematología Pediatrica, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Johannes H', 'Initials': 'JH', 'LastName': 'Merks', 'Affiliation': ""Princess Máxima Center for Paediatric Oncology, Utrecht, Netherlands; Department of Paediatric Oncology, Emma Children's Hospital-Academic Medical Center Amsterdam, Netherlands.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kelsey', 'Affiliation': ""Department of Paediatric Histopathology, Royal Manchester Children's Hospital, Manchester, UK.""}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Martelli', 'Affiliation': 'Department of Paediatric Surgery, Hôpital Bicêtre-Hôpitaux Universitaires Paris Sud, Assistance Publique-Hôpitaux de Paris, Le Kremlin Bicêtre, Paris, France.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Minard-Colin', 'Affiliation': 'Department of Paediatric and Adolescent Oncology, Gustave-Roussy, Villejuif, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Orbach', 'Affiliation': 'SIREDO Oncology Center, Institut Curie, PSL University, Paris, France.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Glosli', 'Affiliation': 'Department of Paediatric Research and Department of Paediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Chisholm', 'Affiliation': 'Children and Young Peoples Unit, Royal Marsden Hospital, Sutton, Surrey, UK.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Casanova', 'Affiliation': 'Paediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Zanetti', 'Affiliation': ""Haematology Oncology Division, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Devalck', 'Affiliation': 'Paediatric Haematology and Oncology, Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Ben-Arush', 'Affiliation': ""Joan and Sanford Weill Pediatric Hematology Oncology and Bone Marrow Transplantation Division, Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mudry', 'Affiliation': ""University Children's Hospital Brno, Czech Republic.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Ferman', 'Affiliation': 'Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Meriel', 'Initials': 'M', 'LastName': 'Jenney', 'Affiliation': ""Department of Paediatric Oncology, Children's Hospital for Wales, Heath Park, Cardiff, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ferrari', 'Affiliation': 'Paediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30617-5']
1810,31656094,"Genetic Susceptibility, Dietary Protein Intake, and Changes of Blood Pressure: The POUNDS Lost Trial.","High blood pressure (BP) is closely related to obesity, and weight loss lowers BP. Evidence has shown considerable interpersonal variation of changes in BP among people experiencing weight loss, and such variation might be partly determined by genetic factors. We assessed the changes in systolic and diastolic BP (SBP/DBP) among 692 participants randomly assigned to 1 of 4 diets varying in macronutrient content for 2 years. Two separate polygenic scores (SBP/DBP-PGS derived from 52/50 single nucleotide polymorphisms) were built for each participant based on 66 BP-associated single nucleotide polymorphisms. During a 2-year intervention, participants in the bottom versus upper tertile of SBP/DBP-PGS had a greater decrease in SBP (△SBP at 6, 12, and 24 months: -3.84 versus -1.61, -4.76 versus -2.75, -2.49 versus -1.63;  P =0.001) or in DBP (△DBP at 6, 12, and 24 months: -3.09 versus -1.34, -2.69 versus -1.44, -1.82 versus -0.53;  P <0.001). We also found gene-diet interaction on changes in SBP from baseline to 24 months ( P interaction =0.009). Among participants assigned to a high-protein diet, those with a lower SBP-polygenic scores had greater decreases in SBP at months 6 ( P =0.018), months 12 ( P =0.007), and months 24 ( P =0.089); while no significant difference was observed across the SBP-polygenic scores tertile groups among those assigned to an average-protein diet (all  P  values >0.05). Our data indicate that genetic susceptibility may affect BP changes in response to weight-loss diet interventions, and protein intake may modify the genetic associations with changes in BP. This trial was registered at URL: http://www.clinicaltrials.gov. Unique identifier: NCT00072995.",2019,We also found gene-diet interaction on changes in SBP from baseline to 24 months ( P interaction =0.009).,['692 participants randomly assigned to 1 of 4 diets varying in macronutrient content for 2 years'],[],"['SBP (△SBP', 'systolic and diastolic BP (SBP/DBP', 'SBP-polygenic scores', 'Genetic Susceptibility, Dietary Protein Intake, and Changes of Blood Pressure', 'SBP', 'High blood pressure (BP']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0314657', 'cui_str': 'Genetic Susceptibility'}, {'cui': 'C0425424', 'cui_str': 'Dietary protein intake (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}]",692.0,0.0165496,We also found gene-diet interaction on changes in SBP from baseline to 24 months ( P interaction =0.009).,"[{'ForeName': 'Dianjianyi', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'From the Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA (D.S., T.Z., X.L., Y.H., Z.L., L.Q.).'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA (D.S., T.Z., X.L., Y.H., Z.L., L.Q.).'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'From the Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA (D.S., T.Z., X.L., Y.H., Z.L., L.Q.).'}, {'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'From the Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA (D.S., T.Z., X.L., Y.H., Z.L., L.Q.).'}, {'ForeName': 'Zhaoxia', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'From the Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA (D.S., T.Z., X.L., Y.H., Z.L., L.Q.).'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA (G.A.B.).'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA (F.M.S., L.Q.).'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'From the Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA (D.S., T.Z., X.L., Y.H., Z.L., L.Q.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.13510']
1811,31424550,Genomic investigation of Staphylococcus aureus recovered from Gambian women and newborns following an oral dose of intra-partum azithromycin.,"BACKGROUND


Oral azithromycin given during labour reduces carriage of bacteria responsible for neonatal sepsis, including Staphylococcus aureus. However, there is concern that this may promote drug resistance.
OBJECTIVES


Here, we combine genomic and epidemiological data on S. aureus isolated from mothers and babies in a randomized intra-partum azithromycin trial (PregnAnZI) to describe bacterial population dynamics and resistance mechanisms.
METHODS


Participants from both arms of the trial, who carried S. aureus in day 3 and day 28 samples post-intervention, were included. Sixty-six S. aureus isolates (from 7 mothers and 10 babies) underwent comparative genome analyses and the data were then combined with epidemiological data. Trial registration (main trial): ClinicalTrials.gov Identifier NCT01800942.
RESULTS


Seven S. aureus STs were identified, with ST5 dominant (n = 40, 61.0%), followed by ST15 (n = 11, 17.0%). ST5 predominated in the placebo arm (73.0% versus 49.0%, P = 0.039) and ST15 in the azithromycin arm (27.0% versus 6.0%, P = 0.022). In azithromycin-resistant isolates, msr(A) was the main macrolide resistance gene (n = 36, 80%). Ten study participants, from both trial arms, acquired azithromycin-resistant S. aureus after initially harbouring a susceptible isolate. In nine (90%) of these cases, the acquired clone was an msr(A)-containing ST5 S. aureus. Long-read sequencing demonstrated that in ST5, msr(A) was found on an MDR plasmid.
CONCLUSIONS


Our data reveal in this Gambian population the presence of a dominant clone of S. aureus harbouring plasmid-encoded azithromycin resistance, which was acquired by participants in both arms of the study. Understanding these resistance dynamics is crucial to defining the public health drug resistance impacts of azithromycin prophylaxis given during labour in Africa.",2019,"ST5 predominated in the placebo arm (73.0% versus 49.0%, P = 0.039) and ST15 in the azithromycin arm (27.0% versus 6.0%, P = 0.022).","['Participants from both arms of the trial, who carried S. aureus in day 3 and day 28 samples post-intervention, were included', 'Sixty-six S. aureus isolates (from 7 mothers and 10 babies', 'resistant S. aureus after initially harbouring a susceptible isolate']","['placebo', 'azithromycin', 'azithromycin prophylaxis']",[],"[{'cui': 'C0230348', 'cui_str': 'Both upper arms (body structure)'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0475311', 'cui_str': 'Harbor (environment)'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]",[],10.0,0.421266,"ST5 predominated in the placebo arm (73.0% versus 49.0%, P = 0.039) and ST15 in the azithromycin arm (27.0% versus 6.0%, P = 0.022).","[{'ForeName': 'Abdoulie', 'Initials': 'A', 'LastName': 'Bojang', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Baines', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Donovan', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Guerillot', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kerrie', 'Initials': 'K', 'LastName': 'Stevens', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Higgs', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bottomley', 'Affiliation': 'Medical Research Council Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Ousman', 'Initials': 'O', 'LastName': 'Secka', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Schultz', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Gonçalves da Silva', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Seemann', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Stinear', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Roca', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Howden', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz341']
1812,30315625,Nifedipine alone or combined with sildenafil citrate for management of threatened preterm labour: a randomised trial.,"OBJECTIVE


To study the tocolytic action of nifedipine combined with sildenafil citrate (SC) and if the combination is superior to nifedipine alone in inhibiting threatened preterm labour (PTL).
DESIGN


Prospective randomised study.
SETTING


An Egyptian university hospital.
POPULATION


Women with threatened PTL who received either nifedipine with SC or nifedipine alone.
METHODS


Patients were randomly allocated to receive either (1) nifedipine 20 mg orally (stat dose), followed by 10 mg orally every 6-8 hours at the same time as vaginal administration of SC (25 mg at 8-hourly intervals) or (2) nifedipine alone. Medications were continued for 48-72 hours.
MAIN OUTCOME MEASURES


The percentage of women who remained undelivered during hospitalisation.
RESULTS


From January 2015 to November 2016, 239 women were randomised. The baseline characteristics of participants were similar. Nifedipine combined with SC was associated with more women remaining undelivered (81.8 versus 68.6%; P = 0.018) during hospitalisation. Regarding secondary outcomes, the addition of SC was also associated with fewer deliveries within 7 days of admission (9.1 versus 20.3%; P = 0.014), prolonged latency (29 versus 7 days; P = 0.002), fewer admissions to neonatal intensive care units (31.4 versus 44.1%; P = 0.043), fewer very preterm deliveries (from 28 to <32 weeks, 20.7 versus 38.1%; P = 0.043), and increased neonatal birthweight (1900 versus 1500 g; P = 0.018).
CONCLUSIONS


Vaginal SC combined with nifedipine is an effective option for tocolytic therapy during threatened PTL.
TWEETABLE ABSTRACT


Vaginal SC enhances the tocolytic effect of nifedipine.",2019,Nifedipine combined with SC was associated with more women remaining undelivered (81.8 versus 68.6%; P = 0.018) during hospitalisation.,"['threatened preterm labour', 'Patients', 'An Egyptian university hospital', 'From January 2015 to November 2016, 239 women were randomised', 'Women with threatened PTL who received either']","['Nifedipine alone or combined with sildenafil citrate', 'nifedipine 20', 'nifedipine', 'nifedipine combined with sildenafil citrate (SC', 'nifedipine alone', 'nifedipine with SC or nifedipine alone', 'Nifedipine']","['fewer deliveries within 7\xa0days of admission', 'preterm deliveries', 'tocolytic effect', 'neonatal birthweight', 'admissions to neonatal intensive care units', 'percentage of women who remained undelivered during hospitalisation', 'prolonged latency']","[{'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337801', 'cui_str': 'Egyptians (ethnic group)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}]","[{'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C3179497', 'cui_str': 'Tocolytic Effect'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]",239.0,0.33793,Nifedipine combined with SC was associated with more women remaining undelivered (81.8 versus 68.6%; P = 0.018) during hospitalisation.,"[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Maher', 'Affiliation': 'Faculty of Medicine, Menoufia University, Shebin-Elkom, Egypt.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Sayyed', 'Affiliation': 'Faculty of Medicine, Menoufia University, Shebin-Elkom, Egypt.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'El-Khadry', 'Affiliation': 'Department of Epidemiology and Biostatistics, National Liver Institute, Menoufia University, Shebin-Elkom, Egypt.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.15503']
1813,30061051,"Safety and immunogenicity of Pfs25H-EPA/Alhydrogel, a transmission-blocking vaccine against Plasmodium falciparum: a randomised, double-blind, comparator-controlled, dose-escalation study in healthy Malian adults.","BACKGROUND


Pfs25H-EPA is a protein-protein conjugate transmission-blocking vaccine against Plasmodium falciparum that is safe and induces functional antibodies in malaria-naive individuals. In this field trial, we assessed Pfs25H-EPA/Alhydrogel for safety and functional immunogenicity in Malian adults.
METHODS


This double-blind, randomised, comparator-controlled, dose-escalation trial in Bancoumana, Mali, was done in two staggered phases, an initial pilot safety assessment and a subsequent main phase. Healthy village residents aged 18-45 years were eligible if they had normal laboratory results (including HIV, hepatitis B, hepatitis C tests) and had not received a previous malaria vaccine or recent immunosuppressive drugs, vaccines, or blood products. Participants in the pilot safety cohort and the main cohort were assigned (1:1) by block randomisation to a study vaccine group. Participants in the pilot safety cohort received two doses of Pfs25H-EPA/Alhydrogel 16 μg or Euvax B (comparator vaccine), and participants in the main cohort received Pfs25H-EPA/Alhydrogel 47 μg or comparator vaccine (Euvax B for the first, second, and third vaccinations and Menactra for the fourth vaccination). Participants and investigators were masked to group assignment, and randomisation codes in sealed envelopes held by a site pharmacist. Vials with study drug for injection were covered by opaque tape and labelled with a study identification number. Group assignments were unmasked at final study visit. The primary outcomes were safety and tolerability for all vaccinees. The secondary outcome measure was immunogenicity 14 days after vaccination in the per-protocol population, as confirmed by the presence of antibodies against Pfs25H measured by ELISA IgG and antibody functionality assessed by standard membrane feeding assays and by direct skin feeding assays. This trial is registered with ClinicalTrials.gov, number NCT01867463.
FINDINGS


Between May 15, and Jun 16, 2013, 230 individuals were screened for eligibility. 20 individuals were enrolled in the pilot safety cohort; ten participants were assigned to receive Pfs25H-EPA/Alhydrogel 16 μg, and ten participants were assigned to receive comparator vaccine. 100 individuals were enrolled in the main cohort; 50 participants were assigned to receive Pfs25H-EPA/Alhydrogel 47 μg, and 50 participants were assigned to receive comparator vaccine. Compared with comparator vaccinees, Pfs25H vaccinees had more solicited adverse events (137 events vs 86 events; p=0·022) and treatment-related adverse events (191 events vs 126 events, p=0·034), but the number of other adverse events did not differ between study vaccine groups (792 vs 683). Pfs25H antibody titres increased with each dose, with a peak geometric mean of 422·3 ELISA units (95% CI 290-615) after the fourth dose, but decreased relatively rapidly thereafter, with a half-life of 42 days for anti-Pfs25H and 59 days for anti-EPA (median ratio of titres at day 600 to peak, 0·19 for anti-Pfs25H vs 0·29 for anti-EPA; p=0·009). Serum transmission-reducing activity was greater for Pfs25H than for comparator vaccine after the fourth vaccine dose (p<0·001) but not after the third dose (p=0·09). Repeated direct skin feeds were well tolerated, but the number of participants who infected at least one mosquito did not differ between Pfs25H and comparator vaccinees after the fourth dose (p=1, conditional exact).
INTERPRETATION


Pfs25H-EPA/Alhydrogel was well tolerated and induced significant serum activity by standard membrane feeding assays but transmission blocking activity was not confirmed by weekly direct skin feed. This activity required four doses, and titres decreased rapidly after the fourth dose. Alternative antigens or combinations should be assessed to improve activity.
FUNDING


Division of Intramural Research, National Institute of Allergy and Infectious Diseases.",2018,Serum transmission-reducing activity was greater for Pfs25H than for comparator vaccine after the fourth vaccine dose (p<0·001) but not after the third dose (p=0·09).,"['malaria-naive individuals', '47 μg, and 50 participants', '100 individuals were enrolled in the main cohort; 50 participants', 'Malian adults', 'Between May 15, and Jun 16, 2013, 230 individuals were screened for eligibility', '20 individuals were enrolled in the pilot safety cohort; ten participants were assigned to receive', 'Healthy village residents aged 18-45 years were eligible if they had normal laboratory results (including HIV, hepatitis B, hepatitis C tests) and had not received a previous malaria vaccine or recent immunosuppressive drugs, vaccines, or blood products', 'healthy Malian adults']","['Pfs25H-EPA/Alhydrogel 47 μg or comparator vaccine (Euvax B for the first, second, and third vaccinations and Menactra for the fourth vaccination', 'Pfs25H-EPA/Alhydrogel 16 μg', 'Pfs25H-EPA/Alhydrogel', 'comparator vaccine', 'Pfs25H-EPA/Alhydrogel 16 μg or Euvax B (comparator vaccine']","['Serum transmission-reducing activity', 'safety and tolerability', 'Pfs25H antibody titres', 'adverse events', 'immunogenicity 14 days after vaccination', 'number of other adverse events', 'solicited adverse events', 'presence of antibodies against Pfs25H measured by ELISA IgG and antibody functionality assessed by standard membrane feeding assays and by direct skin feeding assays']","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0206255', 'cui_str': 'Malarial Vaccines'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}]","[{'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0733770', 'cui_str': 'Alhydrogel'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1451139', 'cui_str': 'Euvax-B'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1567129', 'cui_str': 'Menactra'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]",10.0,0.602673,Serum transmission-reducing activity was greater for Pfs25H than for comparator vaccine after the fourth vaccine dose (p<0·001) but not after the third dose (p=0·09).,"[{'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Center, Mali-National Institute of Allergy and Infectious Diseases International Center for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Healy', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Mahamadoun H', 'Initials': 'MH', 'LastName': 'Assadou', 'Affiliation': 'Malaria Research and Training Center, Mali-National Institute of Allergy and Infectious Diseases International Center for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Gabriel', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Mamady', 'Initials': 'M', 'LastName': 'Kone', 'Affiliation': 'Malaria Research and Training Center, Mali-National Institute of Allergy and Infectious Diseases International Center for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Kourane', 'Initials': 'K', 'LastName': 'Sissoko', 'Affiliation': 'Malaria Research and Training Center, Mali-National Institute of Allergy and Infectious Diseases International Center for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Intimbeye', 'Initials': 'I', 'LastName': 'Tembine', 'Affiliation': 'Malaria Research and Training Center, Mali-National Institute of Allergy and Infectious Diseases International Center for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Merepen A', 'Initials': 'MA', 'LastName': 'Guindo', 'Affiliation': 'Malaria Research and Training Center, Mali-National Institute of Allergy and Infectious Diseases International Center for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': ""M'Bouye"", 'Initials': 'M', 'LastName': 'Doucoure', 'Affiliation': 'Malaria Research and Training Center, Mali-National Institute of Allergy and Infectious Diseases International Center for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Karamoko', 'Initials': 'K', 'LastName': 'Niaré', 'Affiliation': 'Malaria Research and Training Center, Mali-National Institute of Allergy and Infectious Diseases International Center for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Amagana', 'Initials': 'A', 'LastName': 'Dolo', 'Affiliation': 'Malaria Research and Training Center, Mali-National Institute of Allergy and Infectious Diseases International Center for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Rausch', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Narum', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Jones', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'MacDonald', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Daming', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Rathy', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Muratova', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Ibrahima', 'Initials': 'I', 'LastName': 'Baber', 'Affiliation': 'Malaria Research and Training Center, Mali-National Institute of Allergy and Infectious Diseases International Center for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Mamadou B', 'Initials': 'MB', 'LastName': 'Coulibaly', 'Affiliation': 'Malaria Research and Training Center, Mali-National Institute of Allergy and Infectious Diseases International Center for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Fay', 'Affiliation': 'Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Sekou F', 'Initials': 'SF', 'LastName': 'Traore', 'Affiliation': 'Malaria Research and Training Center, Mali-National Institute of Allergy and Infectious Diseases International Center for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Ogobara K', 'Initials': 'OK', 'LastName': 'Doumbo', 'Affiliation': 'Malaria Research and Training Center, Mali-National Institute of Allergy and Infectious Diseases International Center for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Patrick E', 'Initials': 'PE', 'LastName': 'Duffy', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA. Electronic address: patrick.duffy@nih.gov.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30344-X']
1814,30552406,"Effects of sartans and low-dose statins on cerebral white matter hyperintensities and cognitive function in older patients with hypertension: a randomized, double-blind and placebo-controlled clinical trial.","Cerebral white matter hyperintensities (WMHs) and cognitive impairment are common in elderly hypertensive patients, and more needs to be learned about their prevention and treatment. Our aim was to investigate the effect of low-dose statins on WMH and cognitive function in elderly patients undergoing antihypertensive treatment. A total of 732 elderly hypertensive patients taking hydrochlorothiazide as their baseline medication were randomized using a 2 × 2 factorial design with antihypertensive (telmisartan vs. placebo) and lipid-modulating (low-dose rosuvastatin vs. placebo) arms. Brain magnetic resonance imaging (MRI) and cognitive function data were obtained. After a mean follow-up time of 59.8 (range 12-65) months, there were no differences in WMH progression and cognitive function decline over time between the groups in the antihypertensive arm. The risks of new-incident WMH Fazekas scale scores ≥ 2 and the incidence of cognitive impairment did not differ between the telmisartan and placebo groups. Rosuvastatin use was associated with lower risks of new-incident Fazekas scale scores ≥2 (hazard ratio = 0.500; 95% confidence interval: 0.34-0.74) and cognitive impairment (hazard ratio = 0.54; 95% confidence interval: 0.36-0.80). Telmisartan interacted with rosuvastatin on reducing WMH progression and cognitive function decline. Findings suggest that low-dose rosuvastatin could reduce WMH progression and cognitive function decline in antihypertensive patients, as demonstrated by the interaction between telmisartan and low-dose rosuvastatin to this effect.",2019,The risks of new-incident WMH Fazekas scale scores ≥ 2 and the incidence of cognitive impairment did not differ between the telmisartan and placebo groups.,"['732 elderly hypertensive patients taking', 'elderly hypertensive patients', 'elderly patients undergoing antihypertensive treatment', 'older patients with hypertension']","['Telmisartan', 'placebo', 'low-dose statins', 'antihypertensive (telmisartan vs. placebo) and lipid-modulating (low-dose rosuvastatin vs. placebo', 'Rosuvastatin', 'hydrochlorothiazide', 'sartans and low-dose statins', 'Brain magnetic resonance imaging (MRI', 'telmisartan', 'rosuvastatin']","['risks of new-incident WMH Fazekas scale scores ≥\u20092 and the incidence of cognitive impairment', 'lower risks of new-incident Fazekas scale scores', 'WMH and cognitive function', 'WMH progression and cognitive function decline', 'cognitive impairment', 'cerebral white matter hyperintensities and cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C1563745', 'cui_str': 'Selective Angiotensin II Receptor Antagonists'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0152295', 'cui_str': 'Cerebral white matter structure'}]",732.0,0.140507,The risks of new-incident WMH Fazekas scale scores ≥ 2 and the incidence of cognitive impairment did not differ between the telmisartan and placebo groups.,"[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China.'}, {'ForeName': 'Yingxin', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Yuanli', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Community, Lanshan District People Hospital, Linyi, Shandong, 276002, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Duan', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The Second Hospital of Shandong University, Jinan, Shandong, 250000, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Sheng', 'Affiliation': 'Department of Cardiology, The Second Hospital of Shandong University, Jinan, Shandong, 250000, China.'}, {'ForeName': 'Tiantian', 'Initials': 'T', 'LastName': 'Ji', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Shangwen', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Gong', 'Affiliation': 'The Russel H Morgan Department of Radiology and Radiological Sciences, The Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chai', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China. zhendongliu876@126.com.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-018-0165-7']
1815,28579907,The comparative study of clinical efficacy and safety of baclofen vs tolperisone in spasticity caused by spinal cord injury.,"In the present study we compared the clinical efficacy and safety of baclofen vs tolperisone in spasticity caused by spinal cord injury. A total of 150 patients were enrolled in the present study and were divided into two groups with 75 patients in each group, receiving baclofen or tolperisone, respectively. We used Modified Ashworth Scale, Medical research council scale, Barthel Index, and Coefficient of efficacy to measure clinical efficacy. After 6-week treatment, both groups demonstrated significant improvement in muscle tone, muscle strength and functional outcome (Group I, 1.55 ± 0.053, 2.79 ± 0.032, 59.31 ± 1.32; Group II, 1.57 ± 0.053, 3.04 ± 0.032, 73 ± 1.32 respectively). There was no significant difference regarding improvement in muscle tone and muscle strength between the two groups (Group I, 1.055 ± 0.053 vs Group II, 1.57 ± 0.053; Group I, 2.79 ± 0.032 vs Group II, 3.04 ± 0.032, p > 0.05). However, the improvement in functional outcomes was greater in group II as compared to that in group I (Group I, 59.31 ± 1.32 vs Group II, 73 ± 1.32, p < 0.05). In addition, overall efficacy coefficient was greater for group II as compared to group I (Group I, 3.6 vs Group II, 2.3, p < 0.05). Group I had more side effects compared to Group II. Compared to baclofen, tolperisone offers greater improvement in activities of daily living compared to baclofen.",2017,"There was no significant difference regarding improvement in muscle tone and muscle strength between the two groups (Group I, 1.055 ± 0.053 vs Group II, 1.57 ± 0.053; Group I, 2.79 ± 0.032 vs Group II, 3.04 ± 0.032, p > 0.05).","['A total of 150 patients were enrolled in the present study and were divided into two groups with 75 patients in each group, receiving', 'spasticity caused by spinal cord injury']","['baclofen vs tolperisone', 'baclofen or tolperisone']","['activities of daily living', 'side effects', 'overall efficacy coefficient', 'functional outcomes', 'muscle tone and muscle strength', 'muscle tone, muscle strength and functional outcome']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0040382', 'cui_str': 'Tolperisone'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0549465', 'cui_str': 'Muscle tone (observable entity)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",150.0,0.0161336,"There was no significant difference regarding improvement in muscle tone and muscle strength between the two groups (Group I, 1.055 ± 0.053 vs Group II, 1.57 ± 0.053; Group I, 2.79 ± 0.032 vs Group II, 3.04 ± 0.032, p > 0.05).","[{'ForeName': 'Dejun', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': ""Department of Orthopedics, Jianyang People's Hospital of Sichuan, Jianyang 641400, China.""}, {'ForeName': 'Guoyong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': ""Department of Orthopedics, Jianyang People's Hospital of Sichuan, Jianyang 641400, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': ""Department of Orthopedics, Jianyang People's Hospital of Sichuan, Jianyang 641400, China.""}, {'ForeName': 'Zhaoyao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedics, Jianyang People's Hospital of Sichuan, Jianyang 641400, China.""}, {'ForeName': 'Fayou', 'Initials': 'F', 'LastName': 'He', 'Affiliation': ""Department of Orthopedics, Jianyang People's Hospital of Sichuan, Jianyang 641400, China.""}, {'ForeName': 'Xiaping', 'Initials': 'X', 'LastName': 'Mou', 'Affiliation': ""Department of Orthopedics, Jianyang People's Hospital of Sichuan, Jianyang 641400, China.""}, {'ForeName': 'Qingmao', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Department of Orthopedics, Jianyang People's Hospital of Sichuan, Jianyang 641400, China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedics, Jianyang People's Hospital of Sichuan, Jianyang 641400, China.""}]",Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society,['10.1016/j.jsps.2017.04.041']
1816,31305949,Effect of a Solution-Focused Approach on Self-Efficacy and Self-Esteem in Turkish Adolescents With Attention-Deficit/Hyperactivity Disorder.,"The aim of the current research was to evaluate the effect of a solution-focused approach on levels of self-efficacy and self-esteem in adolescents with attention-deficit/hyperactivity disorder (ADHD). A mixed design was used, where the quantitative aspect was a randomized controlled study and the qualitative aspect was a case study design. Adolescents with ADHD (N = 41) were randomized into intervention or control groups. Control groups received existing treatment in outpatient clinics, whereas interviews based on a solution-focused approach were conducted with the intervention groups. After the interventions, differences were noted between groups with time, self-efficacy, and self-esteem, with increases in self-efficacy and self-esteem. Significant differences were found between postintervention and follow-up scores. Six themes were determined in the qualitative findings. Nurses in the adolescent mental health field can use the principles and techniques of the solution-focused approach when providing care. [Journal of Psychosocial Nursing and Mental Health Services, 57(11), 45-55.].",2019,"After the interventions, differences were noted between groups with time, self-efficacy, and self-esteem, with increases in self-efficacy and self-esteem.","['Adolescents with ADHD', 'adolescents with attention-deficit/hyperactivity disorder (ADHD', 'Turkish Adolescents With Attention Deficit/Hyperactivity Disorder']","['Solution-Focused Approach', 'solution-focused approach']","['levels of self-efficacy and self-esteem', 'Self-Efficacy and Self-Esteem', 'time, self-efficacy, and self-esteem', 'self-efficacy and self-esteem']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}]","[{'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0338505,"After the interventions, differences were noted between groups with time, self-efficacy, and self-esteem, with increases in self-efficacy and self-esteem.","[{'ForeName': 'Dudu', 'Initials': 'D', 'LastName': 'Karakaya', 'Affiliation': ''}, {'ForeName': 'Gönül', 'Initials': 'G', 'LastName': 'Özgür', 'Affiliation': ''}]",Journal of psychosocial nursing and mental health services,['10.3928/02793695-20190708-01']
1817,30622317,Nebivolol reduces short-term blood pressure variability more potently than irbesartan in patients with intradialytic hypertension.,"Increased blood pressure (BP) variability (BPV) is associated with high cardiovascular risk in hemodialysis. Studies on the effects of antihypertensive drugs on BPV in hemodialysis are scarce. This study examines the effects of nebivolol and irbesartan on short-term BPV in patients with intradialytic hypertension. This randomized-cross-over study included 38 patients (age: 60.4 ± 11.1 years, male: 65.8%) with intradialytic hypertension (intradialytic-SBP increase ≥ 10 mmHg at ≥4 over 6 consecutive sessions). After the baseline evaluation, participants were randomized to nebivolol 5 mg and subsequently irbesartan 150 mg, or vice versa, with a two-week wash-out period before initiation of the second drug. Patients underwent three respective 24 h-ABPM sessions starting before a midweek-session. We calculated the standard deviation (SD), weighted SD (wSD), coefficient of variation (CV), and average real variability (ARV) of BP with validated formulas. The post-hemodialysis and 24 h-SBP and DBP levels were significantly lower after treatment with both drugs. The systolic-BPV indices were marginally lower after nebivolol but not after irbesartan compared to baseline (SD: baseline 15.70 ± 4.69; nebivolol 14.45 ± 3.37, p = 0.090; irbesartan 15.39 ± 3.85, p = 0.706; wSD: 14.62 ± 4.36 vs 13.40 ± 3.07, p = 0.053 vs 14.36 ± 3.47, p = 0.805, respectively). The diastolic-BPV indices decreased with nebivolol and increased with irbesartan, resulting in significant differences between the two drugs (SD: baseline 10.56 ± 2.50; nebivolol 9.75 ± 2.12; irbesartan 10.84 ± 1.98, between-drug p = 0.014; wSD: baseline 9.86 ± 2.12; nebivolol 9.34 ± 2.01; irbesartan 10.25 ± 2.01, between-drug p = 0.029). The diastolic-BPV during intradialytic and day-time periods was marginally lower with nebivolol than with irbesartan. During nighttime, the BPV indices were unchanged with either drug. The short-term BPV was reduced after nebivolol but not after irbesartan treatment in patients with intradialytic hypertension. These findings suggest that sympathetic-overdrive may be a major factor that affects BPV in intradialytic hypertension patients.",2019,"The systolic-BPV indices were marginally lower after nebivolol but not after irbesartan compared to baseline (SD: baseline 15.70 ± 4.69; nebivolol 14.45 ± 3.37, p = 0.090; irbesartan 15.39 ± 3.85, p = 0.706; wSD: 14.62 ± 4.36 vs 13.40 ± 3.07, p = 0.053 vs 14.36 ± 3.47, p = 0.805, respectively).","['38 patients (age: 60.4\u2009±\u200911.1 years, male: 65.8%) with intradialytic hypertension (intradialytic-SBP increase\u2009≥\u200910\u2009mmHg at ≥4 over 6 consecutive sessions', 'intradialytic hypertension patients', 'patients with intradialytic hypertension']","['Nebivolol', 'nebivolol', 'nebivolol and irbesartan', 'nebivolol 5\u2009mg and subsequently irbesartan 150\u2009mg, or vice versa']","['blood pressure (BP) variability (BPV', 'diastolic-BPV indices', 'BPV indices', 'SBP and DBP levels', 'short-term BPV', 'diastolic-BPV during intradialytic and day-time periods', 'standard deviation (SD), weighted SD (wSD), coefficient of variation (CV), and average real variability (ARV) of BP with validated formulas', 'systolic-BPV indices']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0068475', 'cui_str': 'nebivolol'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}, {'cui': 'C1306211', 'cui_str': 'nebivolol 5 MG'}, {'cui': 'C0986849', 'cui_str': 'irbesartan 150 MG'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1948053', 'cui_str': 'Time periods (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",38.0,0.0273608,"The systolic-BPV indices were marginally lower after nebivolol but not after irbesartan compared to baseline (SD: baseline 15.70 ± 4.69; nebivolol 14.45 ± 3.37, p = 0.090; irbesartan 15.39 ± 3.85, p = 0.706; wSD: 14.62 ± 4.36 vs 13.40 ± 3.07, p = 0.053 vs 14.36 ± 3.47, p = 0.805, respectively).","[{'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Loutradis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Bikos', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Raptis', 'Affiliation': 'Pieria Hemodialysis Unit, Katerini, Greece.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Afkou', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tzanis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Pyrgidis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Stylianos', 'Initials': 'S', 'LastName': 'Panagoutsos', 'Affiliation': 'Department of Nephrology, General Hospital of Alexandroupolis, Alexandroupolis, Greece.'}, {'ForeName': 'Ploumis', 'Initials': 'P', 'LastName': 'Pasadakis', 'Affiliation': 'Department of Nephrology, General Hospital of Alexandroupolis, Alexandroupolis, Greece.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Balaskas', 'Affiliation': 'Section of Nephrology and Hypertension, 1st Department of Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Zebekakis', 'Affiliation': 'Section of Nephrology and Hypertension, 1st Department of Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Liakopoulos', 'Affiliation': 'Section of Nephrology and Hypertension, 1st Department of Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Papagianni', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Parati', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Department of Cardiovascular, Neural and Metabolic Sciences, S.Luca Hospital, Milan, Italy.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Sarafidis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. psarafidis11@yahoo.gr.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-018-0194-2']
1818,30597550,The Developmental Sequence and Relations Between Gesture and Spoken Language in Toddlers With Autism Spectrum Disorder.,"In typical development, gestures precede and predict language development. This study examines the developmental sequence of expressive communication and relations between specific gestural and language milestones in toddlers with autism spectrum disorder (ASD), who demonstrate marked difficulty with gesture production and language. Communication skills across five stages (gestures, word approximations, first words, gesture-word combinations, and two-word combinations) were assessed monthly by blind raters for toddlers with ASD participating in an randomized control trial of parent-mediated treatment (N = 42, 12-30 months). Findings revealed that toddlers acquired skills following a reliable (vs. idiosyncratic) sequence and the majority of toddlers combined gestures with words before combining words in speech, but in contrast to the pattern observed in typical development, a significant subset acquired pointing after first words.",2020,"Findings revealed that toddlers acquired skills following a reliable (vs. idiosyncratic) sequence and the majority of toddlers combined gestures with words before combining words in speech, but in contrast to the pattern observed in typical development, a significant subset acquired pointing after first words.","['Toddlers With Autism Spectrum Disorder', 'toddlers with autism spectrum disorder (ASD']",[],"['Communication skills across five stages (gestures, word approximations, first words, gesture-word combinations, and two-word combinations']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]",[],"[{'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}]",,0.0214743,"Findings revealed that toddlers acquired skills following a reliable (vs. idiosyncratic) sequence and the majority of toddlers combined gestures with words before combining words in speech, but in contrast to the pattern observed in typical development, a significant subset acquired pointing after first words.","[{'ForeName': 'Meagan R', 'Initials': 'MR', 'LastName': 'Talbott', 'Affiliation': 'University of California, Davis.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Young', 'Affiliation': 'University of California, Davis.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Munson', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Estes', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Vismara', 'Affiliation': 'University of California, Davis.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Rogers', 'Affiliation': 'University of California, Davis.'}]",Child development,['10.1111/cdev.13203']
1819,31669451,Enhanced exposure therapy for combat-related Posttraumatic Stress Disorder (PTSD): Study protocol for a randomized controlled trial.,"BACKGROUND


PTSD, which has been identified in up to 23% of post-9-11 veterans, often results in a chronic, pernicious course. Thus, effective treatments are imperative. The Institute of Medicine (IOM) concluded that the only intervention for PTSD with sufficient evidence to conclude efficacy is exposure therapy. This Phase III trial compares the efficacy of exposure therapy for combat-related PTSD delivered in two different formats- via virtual reality exposure therapy (VRE) or prolonged exposure therapy (PE)- combined with D-Cycloserine (DCS), a cognitive enhancer shown to facilitate the extinction of fear.
METHODS/DESIGN


Military personnel of any duty status and civilians deployed to Iraq and Afghanistan were eligible. Participants were randomly assigned to 9 sessions of exposure therapy (VRE or PE) and medication (50 mg DCS or placebo). Participants were treated at three geographically diverse sites. Participants were re-assessed at 3-months post-treatment. The co-primary hypotheses are that (1) DCS will augment response to exposure therapy (both VRE and PE) on PTSD symptoms; (2) VRE will be associated with greater improvement than PE. Genetic and psychophysiological markers will be evaluated as potential moderators and mediators of treatment outcomes as well as secondary outcomes.
DISCUSSION


This study is the first to compare the relative efficacy of DCS-augmented VRE versus PE on PTSD symptoms. The design has several advantages: participants received an active, effective treatment and predictors of response to treatment included genetic and psychobiological measures. The results may directly influence the future delivery of services, and contribute to the development of a standardized treatment protocol.
TRIAL REGISTRATION


NCT01352637.",2019,"This Phase III trial compares the efficacy of exposure therapy for combat-related PTSD delivered in two different formats- via virtual reality exposure therapy (VRE) or prolonged exposure therapy (PE)- combined with D-Cycloserine (DCS), a cognitive enhancer shown to facilitate the extinction of fear.
","['combat-related Posttraumatic Stress Disorder (PTSD', 'Military personnel of any duty status and civilians deployed to Iraq and Afghanistan were eligible']","['virtual reality exposure therapy (VRE) or prolonged exposure therapy (PE)- combined with D-Cycloserine (DCS', 'DCS-augmented VRE versus PE', 'exposure therapy (PE or VRE) and medication (50\u202fmg DCS or placebo']",[],"[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}]","[{'cui': 'C3494470', 'cui_str': 'Virtual Reality Immersion Therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.105617,"This Phase III trial compares the efficacy of exposure therapy for combat-related PTSD delivered in two different formats- via virtual reality exposure therapy (VRE) or prolonged exposure therapy (PE)- combined with D-Cycloserine (DCS), a cognitive enhancer shown to facilitate the extinction of fear.
","[{'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Difede', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, 525 East 68(th) Street, New York, NY 10065, United States. Electronic address: jdifede@med.cornell.edu.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Emory University School of Medicine, 12 Executive Pard Drive, Atlanta, GA 30329, United States.'}, {'ForeName': 'Albert A', 'Initials': 'AA', 'LastName': 'Rizzo', 'Affiliation': 'University of Southern California Institute for Creative Technologies, 12015 East Waterfront Drive, Los Angeles, CA 90094, United States.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wyka', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, 525 East 68(th) Street, New York, NY 10065, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Spielman', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, 525 East 68(th) Street, New York, NY 10065, United States.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Jovanovic', 'Affiliation': 'Emory University School of Medicine, 12 Executive Pard Drive, Atlanta, GA 30329, United States.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Reist', 'Affiliation': 'Department of Research, Long Beach VA Medical Center, 5901 East 7(th) Street, Long Beach, CA 90822, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Roy', 'Affiliation': 'Department of Medicine and Center for Neuroscience and Regenerative Medicine, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD 20814, United States.'}, {'ForeName': 'Seth D', 'Initials': 'SD', 'LastName': 'Norrholm', 'Affiliation': 'Emory University School of Medicine, 12 Executive Pard Drive, Atlanta, GA 30329, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Glatt', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, 525 East 68(th) Street, New York, NY 10065, United States.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, 525 East 68(th) Street, New York, NY 10065, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105857']
1820,27919029,Polymorphism of rs873308 near the transmembrane protein 57 gene is associated with serum lipid levels.,"SNP (single-nucleotide polymorphism) of rs10903129 near the TMEM (transmembrane protein) 57 locus has been associated with TC (total cholesterol) in a previous GWAS (genome-wide association study), but the association of TMEM57 rs873308 SNP and serum lipid levels has not been previously reported. The current study was undertaken to detect the association of the TMEM57 rs873308 SNP and several environmental factors with serum lipid profiles in the Han Chinese and Mulao populations. The genotypes of the TMEM57 rs873308 SNP in 865 individuals of Han Chinese and 902 participants of Mulao nationality were determined by PCR and RFLP (restriction-fragment-length polymorphism) combined with gel electrophoresis and then confirmed by direct sequencing. The T allele frequency of TMEM57 rs873308 SNP was not different between Han and Mulao (23.18% versus 25.72%, P>0.05), but different between males and females in the two ethnic groups (P<0.05). The T allele carriers had lower serum TC, Apo (apolipoprotein) B, HDL-C (high-density lipoprotein cholesterol) levels, ApoA1/ApoB ratio in Han; and lower TAG (triacylglycerol), LDL-C (low-density lipoprotein cholesterol), ApoA1 levels and the ApoA1/ApoB ratio and higher HDL-C levels in Mulao than the T allele non-carriers. There was also different association of the TMEM57 rs873308 SNP and serum lipid profiles between males and females in the both ethnic groups. Serum lipid parameters in the two ethnic groups were also associated with several environmental factors. The association of the TMEM57 rs873308 SNP and serum lipid levels was different in the Han Chinese and Mulao populations and between males and females in the both ethnic groups. There may be a sex-specific association of the TMEM57 rs873308 SNP and serum lipid levels in our study populations.",2014,"The T allele carriers had lower serum TC, Apo (apolipoprotein) B, HDL-C (high-density lipoprotein cholesterol) levels, ApoA1/ApoB ratio in Han; and lower TAG (triacylglycerol), LDL-C (low-density lipoprotein cholesterol), ApoA1 levels and the ApoA1/ApoB ratio and higher HDL-C levels in Mulao than the T allele non-carriers.","['Han Chinese and Mulao populations', '865 individuals of Han Chinese and 902 participants of Mulao nationality']","['TMEM57 rs873308 SNP', 'TMEM (transmembrane protein']","['TMEM57 rs873308 SNP and serum lipid profiles', 'Serum lipid parameters', 'TMEM57 rs873308 SNP and serum lipid levels', 'T allele frequency of TMEM57 rs873308 SNP', 'serum lipid levels', 'serum TC, Apo (apolipoprotein) B, HDL-C (high-density lipoprotein cholesterol) levels, ApoA1/ApoB ratio in Han; and lower TAG (triacylglycerol), LDL-C (low-density lipoprotein cholesterol), ApoA1 levels and the ApoA1/ApoB ratio and higher HDL-C levels']","[{'cui': 'C0641339', 'cui_str': 'HAN(II)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0027473', 'cui_str': 'Nationality'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1287373', 'cui_str': 'Finding of serum lipid levels (finding)'}, {'cui': 'C0017270', 'cui_str': 'Allele Frequency'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0641339', 'cui_str': 'HAN(II)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0184921,"The T allele carriers had lower serum TC, Apo (apolipoprotein) B, HDL-C (high-density lipoprotein cholesterol) levels, ApoA1/ApoB ratio in Han; and lower TAG (triacylglycerol), LDL-C (low-density lipoprotein cholesterol), ApoA1 levels and the ApoA1/ApoB ratio and higher HDL-C levels in Mulao than the T allele non-carriers.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Rui-Xing', 'Initials': 'RX', 'LastName': 'Yin', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China yinruixing@163.com.""}, {'ForeName': 'Quan-Zhen', 'Initials': 'QZ', 'LastName': 'Lin', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Shao-Wen', 'Initials': 'SW', 'LastName': 'Shen', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Jia-Qi', 'Initials': 'JQ', 'LastName': 'Sun', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Guang-Yuan', 'Initials': 'GY', 'LastName': 'Shi', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Jin-Zhen', 'Initials': 'JZ', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiology, Institute of Cardiovascular Diseases, the First Affiliated Hospital, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Clinical Laboratory of the Affiliated Cancer Hospital, Guangxi Medical University, Nanning 530021, Guangxi, People's Republic of China.""}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Wang', 'Affiliation': ""College of Stomatology, Guangxi Medical University, 22 Shuangyong Road, Nanning 530021, Guangxi, People's Republic of China.""}]",Bioscience reports,[]
1821,20020208,Benefits of family and social relationships for Thai parents living with HIV.,"Family and social relationships are important structural supports in Thailand that are likely to influence the health and mental health of persons living with HIV (PLH). Structural equation modeling examined these relationships among 409 PLH in two communities in Thailand. Latent variables were constructed for most outcomes and mediators, with adherence to antiretroviral (ARV) therapy, depression, and disclosure represented by single-item indicators. All models controlled for gender, age, and education. Disclosure was significantly and positively associated with ARV adherence, and to both family functioning and social support. Family functioning and social support were significantly related to the PLH's self-perceptions of health and mental health, as well as being significantly correlated with each other. Better family functioning was significantly associated with better quality of life, better perceived health, fewer symptoms of depression, and greater ARV adherence. Social support was significantly associated with better quality of life and fewer depressive symptoms. These results highlight the important role that an organized and structured family life and social support network can play in encouraging better health outcomes among PLH.",2010,"Family functioning and social support were significantly related to the PLH's self-perceptions of health and mental health, as well as being significantly correlated with each other.","['persons living with HIV (PLH', '409 PLH in two communities in Thailand', 'Thai parents living with HIV']",[],"['adherence to antiretroviral (ARV) therapy, depression, and disclosure represented by single-item indicators', 'ARV adherence', 'quality of life, better perceived health, fewer symptoms of depression, and greater ARV adherence', 'quality of life and fewer depressive symptoms', ""PLH's self-perceptions of health and mental health"", 'Family functioning and social support']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",[],"[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0034380'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity (observable entity)'}, {'cui': 'C0037438'}]",,0.0314163,"Family functioning and social support were significantly related to the PLH's self-perceptions of health and mental health, as well as being significantly correlated with each other.","[{'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Rotheram-Borus', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'Chuleeporn', 'Initials': 'C', 'LastName': 'Jiraphongsa', 'Affiliation': ''}, {'ForeName': 'Siwaporn', 'Initials': 'S', 'LastName': 'Khumtong', 'Affiliation': ''}, {'ForeName': 'Sung-Jae', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-009-0165-6']
1822,31676222,"Odanacatib for the treatment of postmenopausal osteoporosis: results of the LOFT multicentre, randomised, double-blind, placebo-controlled trial and LOFT Extension study.","BACKGROUND


Odanacatib, a cathepsin K inhibitor, reduces bone resorption while maintaining bone formation. Previous work has shown that odanacatib increases bone mineral density in postmenopausal women with low bone mass. We aimed to investigate the efficacy and safety of odanacatib to reduce fracture risk in postmenopausal women with osteoporosis.
METHODS


The Long-term Odanacatib Fracture Trial (LOFT) was a multicentre, randomised, double-blind, placebo-controlled, event-driven study at 388 outpatient clinics in 40 countries. Eligible participants were women aged at least 65 years who were postmenopausal for 5 years or more, with a femoral neck or total hip bone mineral density T-score between -2·5 and -4·0 if no previous radiographic vertebral fracture, or between -1·5 and -4·0 with a previous vertebral fracture. Women with a previous hip fracture, more than one vertebral fracture, or a T-score of less than -4·0 at the total hip or femoral neck were not eligible unless they were unable or unwilling to use approved osteoporosis treatment. Participants were randomly assigned (1:1) to either oral odanacatib (50 mg once per week) or matching placebo. Randomisation was done using an interactive voice recognition system after stratification for previous radiographic vertebral fracture, and treatment was masked to study participants, investigators and their staff, and sponsor personnel. If the study completed before 5 years of double-blind treatment, consenting participants could enrol in a double-blind extension study (LOFT Extension), continuing their original treatment assignment for up to 5 years from randomisation. Primary endpoints were incidence of vertebral fractures as assessed using radiographs collected at baseline, 6 and 12 months, yearly, and at final study visit in participants for whom evaluable radiograph images were available at baseline and at least one other timepoint, and hip and non-vertebral fractures adjudicated as being a result of osteoporosis as assessed by clinical history and radiograph. Safety was assessed in participants who received at least one dose of study drug. The adjudicated cardiovascular safety endpoints were a composite of cardiovascular death, myocardial infarction, or stroke, and new-onset atrial fibrillation or flutter. Individual cardiovascular endpoints and death were also assessed. LOFT and LOFT Extension are registered with ClinicalTrials.gov (number NCT00529373) and the European Clinical Trials Database (EudraCT number 2007-002693-66).
FINDINGS


Between Sept 14, 2007, and Nov 17, 2009, we randomly assigned 16 071 evaluable patients to treatment: 8043 to odanacatib and 8028 to placebo. After a median follow-up of 36·5 months (IQR 34·43-40·15) 4297 women assigned to odanacatib and 3960 assigned to placebo enrolled in LOFT Extension (total median follow-up 47·6 months, IQR 35·45-60·06). In LOFT, cumulative incidence of primary outcomes for odanacatib versus placebo were: radiographic vertebral fractures 3·7% (251/6770) versus 7·8% (542/6910), hazard ratio (HR) 0·46, 95% CI 0·40-0·53; hip fractures 0·8% (65/8043) versus 1·6% (125/8028), 0·53, 0·39-0·71; non-vertebral fractures 5·1% (412/8043) versus 6·7% (541/8028), 0·77, 0·68-0·87; all p<0·0001. Combined results from LOFT plus LOFT Extension for cumulative incidence of primary outcomes for odanacatib versus placebo were: radiographic vertebral fractures 4·9% (341/6909) versus 9·6% (675/7011), HR 0·48, 95% CI 0·42-0·55; hip fractures 1·1% (86/8043) versus 2·0% (162/8028), 0·52, 0·40-0·67; non-vertebral fractures 6·4% (512/8043) versus 8·4% (675/8028), 0·74, 0·66-0·83; all p<0·0001. In LOFT, the composite cardiovascular endpoint of cardiovascular death, myocardial infarction, or stroke occurred in 273 (3·4%) of 8043 patients in the odanacatib group versus 245 (3·1%) of 8028 in the placebo group (HR 1·12, 95% CI 0·95-1·34; p=0·18). New-onset atrial fibrillation or flutter occurred in 112 (1·4%) of 8043 patients in the odanacatib group versus 96 (1·2%) of 8028 in the placebo group (HR 1·18, 0·90-1·55; p=0·24). Odanacatib was associated with an increased risk of stroke (1·7% [136/8043] vs 1·3% [104/8028], HR 1·32, 1·02-1·70; p=0·034), but not myocardial infarction (0·7% [60/8043] vs 0·9% [74/8028], HR 0·82, 0·58-1·15; p=0·26). The HR for all-cause mortality was 1·13 (5·0% [401/8043] vs 4·4% [356/8028], 0·98-1·30; p=0·10). When data from LOFT Extension were included, the composite of cardiovascular death, myocardial infarction, or stroke occurred in significantly more patients in the odanacatib group than in the placebo group (401 [5·0%] of 8043 vs 343 [4·3%] of 8028, HR 1·17, 1·02-1·36; p=0·029, as did stroke (2·3% [187/8043] vs 1·7% [137/8028], HR 1·37, 1·10-1·71; p=0·0051).
INTERPRETATION


Odanacatib reduced the risk of fracture, but was associated with an increased risk of cardiovascular events, specifically stroke, in postmenopausal women with osteoporosis. Based on the overall balance between benefit and risk, the study's sponsor decided that they would no longer pursue development of odanacatib for treatment of osteoporosis.
FUNDING


Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, Kenilworth, NJ, USA.",2019,"Odanacatib was associated with an increased risk of stroke (1·7% [136/8043] vs 1·3% [104/8028],","['consenting participants could enrol in a double-blind extension study (LOFT Extension), continuing their original treatment assignment for up to 5 years from randomisation', 'postmenopausal women with low bone mass', 'participants who received at least one dose of study drug', 'Women with a previous hip fracture, more than one vertebral fracture, or a T-score of less than -4·0 at the total hip or femoral neck were not eligible unless they were unable or unwilling to use approved osteoporosis treatment', 'postmenopausal women with osteoporosis', '388 outpatient clinics in 40 countries', 'Between Sept 14, 2007, and Nov 17, 2009, we randomly assigned 16\u2008071 evaluable patients to treatment: 8043 to odanacatib and 8028 to', 'postmenopausal osteoporosis', 'Eligible participants were women aged at least 65 years who were postmenopausal for 5 years or more, with a femoral neck or total hip bone mineral density T-score between -2·5 and -4·0 if no previous radiographic vertebral fracture, or between -1·5 and -4·0 with a previous vertebral fracture']","['LOFT plus LOFT', 'odanacatib', 'placebo', 'interactive voice recognition system', 'Odanacatib', 'oral odanacatib (50 mg once per week) or matching placebo']","['risk of stroke', 'Safety', 'composite of cardiovascular death, myocardial infarction, or stroke, and new-onset atrial fibrillation or flutter', 'efficacy and safety', 'incidence of vertebral fractures', 'risk of cardiovascular events', 'fracture risk', 'composite of cardiovascular death, myocardial infarction, or stroke', 'radiographic vertebral fractures', 'bone mineral density', 'myocardial infarction', 'Individual cardiovascular endpoints and death', 'hazard ratio (HR', 'New-onset atrial fibrillation or flutter', 'composite cardiovascular endpoint of cardiovascular death, myocardial infarction, or stroke']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0563050', 'cui_str': 'Attic (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C4303745', 'cui_str': 'Treatment for osteoporosis (procedure)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}]","[{'cui': 'C0563050', 'cui_str': 'Attic (environment)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2351970', 'cui_str': 'odanacatib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.693385,"Odanacatib was associated with an increased risk of stroke (1·7% [136/8043] vs 1·3% [104/8028],","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, Portland, OR, USA; Mary MacKillop Center for Health Research, Australian Catholic Unversity, Melbourne, VIC, Australia.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': ""O'Donoghue"", 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Socrates E', 'Initials': 'SE', 'LastName': 'Papapoulos', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Bone', 'Affiliation': 'Michigan Bone and Mineral Clinic, Detroit, MI, USA.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Langdahl', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Douglas P', 'Initials': 'DP', 'LastName': 'Kiel', 'Affiliation': 'Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Cavallari', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'de Villiers', 'Affiliation': 'Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Ling', 'Affiliation': 'Peking Union Medical College, Dongcheng, Beijing, China.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Lippuner', 'Affiliation': 'Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'Department of Public Health, Epidemiology and Health Economics and WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Aging, University of Liège, Liège, Belgium.'}, {'ForeName': 'Jose Adolfo', 'Initials': 'JA', 'LastName': 'Rodriguez-Portales', 'Affiliation': 'Pontifical Catholic University of Chile, Santiago, Chile.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Roux', 'Affiliation': 'Paris Descartes University, Cochin Hospital, Paris, France.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Zanchetta', 'Affiliation': 'Institute of Metabolic Research, Buenos Aires, Argentina.'}, {'ForeName': 'Cristiano A F', 'Initials': 'CAF', 'LastName': 'Zerbini', 'Affiliation': 'Paulista Center of Investigations, São Paulo, Brazil.'}, {'ForeName': 'Jeong-Gun', 'Initials': 'JG', 'LastName': 'Park', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'KyungAh', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Cange', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Laura T', 'Initials': 'LT', 'LastName': 'Grip', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Heyden', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'DaSilva', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Dosinda', 'Initials': 'D', 'LastName': 'Cohn', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Rachid', 'Initials': 'R', 'LastName': 'Massaad', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Boyd B', 'Initials': 'BB', 'LastName': 'Scott', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Verbruggen', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Gurner', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Miller', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Micki L', 'Initials': 'ML', 'LastName': 'Blair', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Adam B', 'Initials': 'AB', 'LastName': 'Polis', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Santora', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lombardi', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Albert T', 'Initials': 'AT', 'LastName': 'Leung', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Kaufman', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA. Electronic address: keith_kaufman@merck.com.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30346-8']
1823,30594934,Effect of Low versus High Frequency Subthalamic Deep Brain Stimulation on Speech Intelligibility and Verbal Fluency in Parkinson's Disease: A Double-Blind Study.,"BACKGROUND


Subthalamic deep brain stimulation (STN-DBS) is an established treatment for late stage Parkinson's disease (PD). Speech intelligibility (SI) and verbal fluency (VF) have been shown to deteriorate following chronic STN-DBS. It has been suggested that speech might respond favourably to low frequency stimulation (LFS).
OBJECTIVE


We examined how SI, perceptual speech characteristics, phonemic and semantic VF and processes underlying it (clustering and switching) respond to LFS of 60 and 80 Hz in comparison to high frequency stimulation (HFS) (110, 130 and 200 Hz).
METHODS


In this double-blind study, 15 STN-DBS PD patients (mean age 65, SD = 5.8, 14 right handed, three females), were assessed at five stimulation frequencies: 60 Hz, 80 Hz, 110 Hz, 130 Hz and 200 Hz. In addition to the clinical neurological assessment of speech, VF and SI were assessed.
RESULTS


SI and in particular articulation, respiration, phonation and prosody improved with LFS (all p < 0.05). Phonemic VF switching improved with LFS (p = 0.005) but this did not translate to an improved phonemic VF score. A trend for improved semantic VF was found. A negative correlation was found between perceptual characteristics of speech and duration of chronic stimulation (all p < 0.05).
CONCLUSIONS


These findings highlight the need for meticulous programming of frequency to maximise SI in chronic STN-DBS. The findings further implicate stimulation frequency in changes to specific processes underlying VF, namely phonemic switching and demonstrate the potential to address such deficits through advanced adjustment of stimulation parameters.",2019,"RESULTS


SI and in particular articulation, respiration, phonation and prosody improved with LFS (all p < 0.05).","[""late stage Parkinson's disease (PD"", ""Parkinson's Disease"", '15 STN-DBS PD patients (mean age 65, SD\u200a=\u200a5.8, 14 right handed, three females), were assessed at five stimulation frequencies: 60\u200aHz, 80\u200aHz, 110\u200aHz, 130\u200aHz and 200\u200aHz']","['Low versus High Frequency Subthalamic Deep Brain Stimulation', 'Subthalamic deep brain stimulation (STN-DBS']","['phonemic VF score', 'Speech intelligibility (SI) and verbal fluency (VF', 'clinical neurological assessment of speech, VF and SI', 'Speech Intelligibility and Verbal Fluency', 'SI and in particular articulation, respiration, phonation and prosody improved with LFS', 'Phonemic VF switching', 'semantic VF', 'perceptual characteristics of speech and duration of chronic stimulation']","[{'cui': 'C1279941', 'cui_str': 'Late stage (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0027853', 'cui_str': 'Neurological Examination'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0031577', 'cui_str': 'Phonation'}, {'cui': 'C0233743', 'cui_str': 'Prosody, function (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",,0.0694114,"RESULTS


SI and in particular articulation, respiration, phonation and prosody improved with LFS (all p < 0.05).","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Grover', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, Unit of Functional Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Georgiev', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, Unit of Functional Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Kalliola', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, Unit of Functional Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Mahlknecht', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, Unit of Functional Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Zacharia', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, Unit of Functional Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Candelario', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, Unit of Functional Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hyam', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, Unit of Functional Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Ludvic', 'Initials': 'L', 'LastName': 'Zrinzo', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, Unit of Functional Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Hariz', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, Unit of Functional Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, Unit of Functional Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Limousin', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, Unit of Functional Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Jahanshahi', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, Unit of Functional Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Tripoliti', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, Unit of Functional Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, UK.'}]",Journal of Parkinson's disease,['10.3233/JPD-181368']
1824,22560371,Effects of D-cycloserine on cue-induced craving and cigarette smoking among concurrent cocaine- and nicotine-dependent volunteers.,"Rates of cigarette smoking are 3- to 4-fold greater among those with cocaine-dependence, and compared to non-users, cocaine users are at greater risk of incurring smoking-related negative health effects and death. The current study examined D-cycloserine's (0 or 50mg once weekly) effects on 1) extinction of cue-induced craving for cigarettes, 2) cigarette smoking in conjunction with cognitive-behavioral therapy, and 3) safety and tolerability in cocaine-dependent smokers. This was a double-blind, placebo-controlled, between groups, outpatient study. Participants (N=29) were concurrent cocaine- and nicotine-dependent volunteers seeking treatment for their cigarette smoking. Study visits were 3 times per week for 4 consecutive weeks. At each visit, participants received cognitive-behavioral therapy for smoking, were exposed to smoking cues. A subset of participants (N=22) returned for 6-month follow-up visits. While craving decreased, no significant effects of D-cycloserine treatment were observed. Likewise, significant decreases in smoking were observed at study days 6 (p<0.002) and 12 (p<0.0001) relative to baseline, although no participants achieved complete abstinence. However, there was no effect of D-cycloserine on cigarette smoking during treatment or at 6-mos follow-up. The treatment was safe and tolerable, with nearly 90% of treatment sessions attended based on an intent-to-treat analysis. While no effects of D-cycloserine on craving or smoking were observed in the current study, the results do suggest that smoking treatment is well accepted and may be effective for cocaine-dependent individuals.",2013,"Likewise, significant decreases in smoking were observed at study days 6 (p<0.002) and 12 (p<0.0001) relative to baseline, although no participants achieved complete abstinence.","['Participants (N=29) were concurrent', 'cocaine-dependent smokers', 'concurrent cocaine- and nicotine-dependent volunteers']","['placebo', 'cocaine- and nicotine-dependent volunteers seeking treatment for their cigarette smoking', '1) extinction of cue-induced craving for cigarettes, 2) cigarette smoking in conjunction with cognitive-behavioral therapy', 'cognitive-behavioral therapy', 'D-cycloserine']","['cigarette smoking', 'craving or smoking', 'complete abstinence', 'cue-induced craving and cigarette smoking', 'smoking', 'Rates of cigarette smoking']","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",29.0,0.0156204,"Likewise, significant decreases in smoking were observed at study days 6 (p<0.002) and 12 (p<0.0001) relative to baseline, although no participants achieved complete abstinence.","[{'ForeName': 'Jin H', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Baylor College of Medicine, Menninger Department of Psychiatry and Behavioral Sciences, United States. Electronic address: jiny@bcm.edu.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Newton', 'Affiliation': 'Baylor College of Medicine, Menninger Department of Psychiatry and Behavioral Sciences, United States.'}, {'ForeName': 'Colin N', 'Initials': 'CN', 'LastName': 'Haile', 'Affiliation': 'Baylor College of Medicine, Menninger Department of Psychiatry and Behavioral Sciences, United States.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Bordnick', 'Affiliation': 'University of Houston, School of Social Work, United States.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Fintzy', 'Affiliation': 'Baylor College of Medicine, Menninger Department of Psychiatry and Behavioral Sciences, United States.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Culbertson', 'Affiliation': 'Baylor College of Medicine, Menninger Department of Psychiatry and Behavioral Sciences, United States.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Mahoney', 'Affiliation': 'Baylor College of Medicine, Menninger Department of Psychiatry and Behavioral Sciences, United States.'}, {'ForeName': 'Rollin Y', 'Initials': 'RY', 'LastName': 'Hawkins', 'Affiliation': 'Baylor College of Medicine, Menninger Department of Psychiatry and Behavioral Sciences, United States.'}, {'ForeName': 'Kathleen R', 'Initials': 'KR', 'LastName': 'LaBounty', 'Affiliation': 'Baylor College of Medicine, Menninger Department of Psychiatry and Behavioral Sciences, United States.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Ross', 'Affiliation': 'Baylor College of Medicine, Menninger Department of Psychiatry and Behavioral Sciences, United States.'}, {'ForeName': 'Adel I', 'Initials': 'AI', 'LastName': 'Aziziyeh', 'Affiliation': 'Baylor College of Medicine, Menninger Department of Psychiatry and Behavioral Sciences, United States.'}, {'ForeName': 'Richard De', 'Initials': 'R', 'LastName': 'La Garza', 'Affiliation': 'Baylor College of Medicine, Menninger Department of Psychiatry and Behavioral Sciences, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2012.03.022']
1825,30587857,"Combined use of a healthy lifestyle smartphone application and usual primary care counseling to improve arterial stiffness, blood pressure and wave reflections: a Randomized Controlled Trial (EVIDENT II Study).","Our aim was to investigate the effects of an intervention that comprised a brief counseling session on lifestyle habits together with the use of the EVIDENT (Lifestyles and arterial aging) application on the modification of markers that indicated different hemodynamic functions, such as arterial stiffness, blood pressure or wave reflections. The EVIDENT II study (Lifestyles and arterial aging) is a randomized clinical trial with two parallel groups. Each participant had an initial visit and two follow-up visits at 3 and 12 months where the peripheral augmentation index-PAIx75 was measured by tonometry, while an oscillometric method was used for the cardio-ankle vascular index-CAVI and brachial-ankle pulse wave velocity-baPWV. Both groups (intervention-IG and control-CG) were briefly counseled on diet and exercise. The IG also received instructions on the use of the EVIDENT II application during the 3 months. The sample (N = 597; 52 ± 11 years; 64% women) was randomized into IG = 291 and CG = 306. Comparing groups, there was a decrease in the PAIx75 favorable to the IG at 3 months (-4.9%, 95% CI: -7.7 to -2.1) and 12 months (-3.9%, 95% CI: -6.8 to -1.0). There was also a nonsignificant reduction of the CAVI at 3 months in the IG. A group effect was observed in the measurement of the PAIx75 over the 12-month follow-up (p = 0.003). This interaction was only observed in women (p = 0.017). In conclusion, the use of the EVIDENT II application achieved a modification of the PAIx75, a marker of wave reflection and vascular tone, in women through lifestyle improvements (physical activity and adherence to the Mediterranean diet). No significant results were found regarding blood pressure or arterial stiffness markers.",2019,"Comparing groups, there was a decrease in the PAIx75 favorable to the IG at 3 months (-4.9%, 95% CI: -7.7 to -2.1) and 12 months (-3.9%, 95% CI: -6.8 to -1.0).",['The sample (N\u2009=\u2009597; 52\u2009±\u200911 years; 64% women'],['healthy lifestyle smartphone application and usual primary care counseling'],"['blood pressure or arterial stiffness markers', 'peripheral augmentation index-PAIx75', 'arterial stiffness, blood pressure and wave reflections', 'CAVI', 'arterial stiffness, blood pressure or wave reflections']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4034558', 'cui_str': 'Cardio-ankle vascular index'}]",,0.0223544,"Comparing groups, there was a decrease in the PAIx75 favorable to the IG at 3 months (-4.9%, 95% CI: -7.7 to -2.1) and 12 months (-3.9%, 95% CI: -6.8 to -1.0).","[{'ForeName': 'José I', 'Initials': 'JI', 'LastName': 'Recio-Rodríguez', 'Affiliation': 'Primary Health Care Research Unit, The Alamedilla Health Center, Health Service of Castilla and Leon (SACYL), Biomedical Research Institute of Salamanca (IBSAL), Primary Care Prevention and Health Promotion Research Network (REDIAPP), Salamanca, Spain. donrecio@gmail.com.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': 'Primary Health Care Research Unit, The Alamedilla Health Center, Health Service of Castilla and Leon (SACYL), Biomedical Research Institute of Salamanca (IBSAL), Primary Care Prevention and Health Promotion Research Network (REDIAPP), Salamanca, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Martin-Cantera', 'Affiliation': 'Primary Health Care Research Unit of Barcelona, Institute IDIAP-Jordi Gol, Barcelona, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Martinez-Vizcaino', 'Affiliation': 'Center for Health and Social Research, University of Castilla-La Mancha, Cuenca, Spain.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Arietaleanizbeaskoa', 'Affiliation': 'Primary Health Care Research Unit of Bizkaia, Basque Health Service-Osakidetza, Bilbao, Spain.'}, {'ForeName': 'Natividad', 'Initials': 'N', 'LastName': 'Gonzalez-Viejo', 'Affiliation': 'Torre Ramona Health Center, Aragon Health Service, Zaragoza, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Menendez-Suarez', 'Affiliation': 'Casa del Barco Health Center, Castilla and León Health Service, Valladolid, Spain.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Gómez-Marcos', 'Affiliation': 'Primary Health Care Research Unit, The Alamedilla Health Center, Health Service of Castilla and Leon (SACYL), Biomedical Research Institute of Salamanca (IBSAL), Primary Care Prevention and Health Promotion Research Network (REDIAPP), Salamanca, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garcia-Ortiz', 'Affiliation': 'Primary Health Care Research Unit, The Alamedilla Health Center, Health Service of Castilla and Leon (SACYL), Biomedical Research Institute of Salamanca (IBSAL), Primary Care Prevention and Health Promotion Research Network (REDIAPP), Salamanca, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-018-0182-6']
1826,31253646,Initiation of Noninvasive Ventilation for Acute Respiratory Failure in a Pediatric Intermediate Care Unit.,"BACKGROUND


Noninvasive ventilation (NIV) is increasingly used to manage acute respiratory failure in children, decreasing the need for mechanical ventilation. Safely managing these patients outside of the ICU improves ICU resource use. We measured the impact of a guideline permitting initiation of NIV in an intermediate care unit (IMCU) on ICU bed use.
METHODS


A guideline for an NIV trial for acute respiratory failure was implemented in a 10-bed IMCU. The guideline stipulated criteria for initiation and maintenance of NIV. There were 4.5 years of intervention data collected. Baseline data were gathered for patients with acute respiratory failure who were transferred from the IMCU to the ICU for NIV initiation in the 3.25 years before guideline implementation.
RESULTS


Three hundred eight patients were included: 101 in the baseline group and 207 in the intervention group. In the intervention group, 143 patients (69%) remained in the IMCU after NIV initiation, and 64 (31%) transferred to the ICU. A total of 656.4 ICU bed-days were saved in the intervention period (3.3 days per patient initiated on NIV in the IMCU). There was a significant decrease in the rate of intubation in the IMCU for patients awaiting ICU transfer (3 patients in the baseline group versus 0 patients in the intervention group;  P  = .035).
CONCLUSIONS


The initiation of NIV in the IMCU for pediatric patients with acute respiratory failure saved ICU bed-days without increasing intubation in the IMCU for patients awaiting transfer. Close monitoring of these critically ill patients is a key component of their safe care.",2019,"There was a significant decrease in the rate of intubation in the IMCU for patients awaiting ICU transfer (3 patients in the baseline group versus 0 patients in the intervention group;  P  = .035).
","['patients with acute respiratory failure who were transferred from the IMCU to the ICU for NIV initiation in the 3.25 years before guideline implementation', 'Acute Respiratory Failure in a Pediatric Intermediate Care Unit', 'pediatric patients with acute respiratory failure saved ICU bed-days without increasing intubation in the IMCU for patients awaiting transfer', 'Three hundred eight patients were included: 101 in the baseline group and 207 in the intervention group']","['Noninvasive ventilation (NIV', 'Noninvasive Ventilation']",['rate of intubation'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure (disorder)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}]",308.0,0.0573005,"There was a significant decrease in the rate of intubation in the IMCU for patients awaiting ICU transfer (3 patients in the baseline group versus 0 patients in the intervention group;  P  = .035).
","[{'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Division of Medicine Critical Care and alla.smith@childrens.harvard.edu.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Kelly', 'Affiliation': 'Division of Medicine Critical Care and.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hurlbut', 'Affiliation': 'Division of Medicine Critical Care and.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Melvin', 'Affiliation': ""Program for Patient Safety and Quality, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Christiana M', 'Initials': 'CM', 'LastName': 'Russ', 'Affiliation': 'Division of Medicine Critical Care and.'}]",Hospital pediatrics,['10.1542/hpeds.2019-0034']
1827,31665873,"Effect of caffeine supplementation on exercise performance, power, markers of muscle damage, and perceived exertion in trained CrossFit men: a randomized, double-blind, placebo-controlled crossover trial.","BACKGROUND


Caffeine is a popular nutritional supplement among athletes. It is frequently used as an ergogenic aid to improve physical performance, delay fatigue, and increase muscle power. However, these effects have not been tested in CrossFit athletes. The aim of this study was to evaluate the effects of acute caffeine supplementation on workout performance, power, markers of muscle damage, and soreness in trained CrossFit men.
METHODS


Nine men (28±2 years) with experience in CrossFit (2±0.3 years) were investigated in a randomized, double-blind, placebo-controlled crossover trial, with a 7-day washout between treatment periods. The athletes received anhydrous caffeine (CAF: 6 mg/kg body mass) or placebo (PLA) 60 minutes before a CrossFit workout with tasks that involved muscle strength, power, gymnastic movements, and metabolic conditioning. Blood samples were collected for creatine kinase (CK), C-reactive protein, and glucose determination. Workout performance, rating of perceived exertion (RPE), delayed-onset muscle soreness (DOMS), muscle strength (handgrip strength) and power (bench throw, jump squat and countermovement jump) were also evaluated.
RESULTS


CAF resulted in higher glucose concentration after workout compared to PLA (+3.2 mmol/L, 95% CI: 2.1 to 4.3 vs. +1.5, 95% CI: -0.1 to 3.0 mmol/L, P=0.01). No differences were found between treatments in workout performance, CK, DOMS, RPE, muscle power and strength.
CONCLUSIONS


Acute CAF supplementation did not alter performance, markers of muscle damage, power, and RPE in trained CrossFit men.",2020,"No differences were found between treatments in workout performance, CK, DOMS, RPE, muscle power and strength.
","['Nine men (28 ± 2 years) with experience in CrossFit (2 ± 0.3 years', 'trained CrossFit men', 'athletes']","['acute caffeine supplementation', 'Acute CAF supplementation', 'placebo (PLA) 60 minutes before a CrossFit workout with tasks that involved muscle strength, power, gymnastic movements, and metabolic conditioning', 'Caffeine', 'anhydrous caffeine (CAF', 'placebo', 'caffeine supplementation', 'PLA']","['creatine kinase (CK), C-reactive protein, and glucose determination', 'higher glucose concentration', 'workout performance, power, markers of muscle damage, and soreness', 'physical performance, delay fatigue', 'Workout performance, rating of perceived exertion (RPE), delayed-onset muscle soreness (DOMS), muscle strength (handgrip strength) and power (bench throw, jump squat and countermovement jump', 'workout performance, CK, DOMS, RPE, muscle power and strength', 'exercise performance, power, markers of muscle damage, and perceived exertion', 'performance, markers of muscle damage, power, and RPE']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C2607857'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560512', 'cui_str': 'Does throw (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.579459,"No differences were found between treatments in workout performance, CK, DOMS, RPE, muscle power and strength.
","[{'ForeName': 'Lorruama J', 'Initials': 'LJ', 'LastName': 'Fogaça', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'Silvia L', 'Initials': 'SL', 'LastName': 'Santos', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'Ronyson C', 'Initials': 'RC', 'LastName': 'Soares', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': 'College of Physical Education and Dance, Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Naves', 'Affiliation': 'College of Physical Education and Dance, Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'Wanderson D', 'Initials': 'WD', 'LastName': 'Dos Santos', 'Affiliation': 'College of Physical Education and Dance, Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Pimentel', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'Martim', 'Initials': 'M', 'LastName': 'Bottaro', 'Affiliation': 'College of Physical Education, University of Brasília, Campus Universitário Darcy Ribeiro, Brasilia, Brazil.'}, {'ForeName': 'João F', 'Initials': 'JF', 'LastName': 'Mota', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goias, Goiania, Brazil - jfemota@gmail.com.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.19.10043-6']
1828,31665874,Efficacy of whole-body suspension training on enhancing functional movement abilities following a supervised or home-based training program.,"BACKGROUND


The purpose of this study was to determine the effects of suspension training on functional movement and body composition, and to compare the effectiveness of home-based training to supervised training.
METHODS


Seventeen healthy subjects (8 males, 9 females, age=21.8±3.4 y) with no recent history of resistance training were randomly assigned to a home-based or supervised training group. Subjects performed an 8-week suspension training program consisting of 10 exercises targeting major muscle groups, twice per week for the duration of the study. Pre- and post-intervention testing included body composition using air displacement plethysmography, and a functional movement screen (FMS) to measure functional movement abilities.
RESULTS


The 8-week training program significantly improved total FMS scores across the whole sample of subjects (Pre=16.4; Post=17.5; P=0.004), with no differences in improvements between groups. When compared separately, only the supervised group significantly improved FMS scores. There was also a significant increase in lean mass across the total sample of subjects (Pre=52.4 kg; Post=53.3 kg; P=0.03) with no differences between groups. But when compared independently, neither group exhibited a significant increase in lean mass.
CONCLUSIONS


When completed as a whole-body exercise program over an 8-week period, suspension training can improve functional ability and increase lean mass in both a supervised and a home-based setting.",2020,"The 8-week training program, significantly improved total FMS scores across the whole sample of subjects (Pre=16.4; Post=17.5; p=0.004), with no differences in improvements between groups.","['Seventeen healthy subjects (8 male, 9 female, age=21.8±3.4 y) with no recent history of resistance training']","['Pre- and post-intervention testing included body composition using air displacement plethysmography, and a Functional Movement Screen (FMS', 'suspension training', 'home- based or supervised training group', 'whole-body suspension training']","['functional movement and body composition', 'lean mass', 'enhancing functional movement abilities', 'total FMS scores', 'FMS scores', 'functional ability and increase lean mass']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",17.0,0.0132355,"The 8-week training program, significantly improved total FMS scores across the whole sample of subjects (Pre=16.4; Post=17.5; p=0.004), with no differences in improvements between groups.","[{'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Kullman', 'Affiliation': 'Department of Health and Human Performance, Cleveland State University, Cleveland, OH, USA - e.kullman@csuohio.edu.'}, {'ForeName': 'Shelby M', 'Initials': 'SM', 'LastName': 'Saylor', 'Affiliation': 'Department of Health and Human Performance, Cleveland State University, Cleveland, OH, USA.'}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Little', 'Affiliation': 'Department of Health and Human Performance, Cleveland State University, Cleveland, OH, USA.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.19.10066-7']
1829,30219394,Systolic Stretch Characterizes the Electromechanical Substrate Responsive to Cardiac Resynchronization Therapy.,"OBJECTIVES


In this study, the authors tested the hypotheses that the systolic stretch index (SSI) developed by computer modeling and applied using echocardiographic strain imaging may characterize the electromechanical substrate predictive of outcome following cardiac resynchronization therapy (CRT). They included patients with QRS width 120 to 149 ms or non-left bundle branch block (LBBB), where clinical uncertainty for CRT exists. They further tested the hypothesis that global longitudinal strain (GLS) has additional prognostic value.
BACKGROUND


Response to CRT is variable. Guidelines favor patient selection by electrocardiographic LBBB with QRS width ≥150 ms.
METHODS


The authors studied 442 patients enrolled in the Adaptive CRT 94-site randomized trial with New York Heart Association functional class III-IV heart failure, ejection fraction ≤35%, and QRS ≥120 ms. A novel computer program semiautomatically calculated the SSI from strain curves as the sum of posterolateral prestretch percent before aortic valve opening and the septal rebound stretch percent during ejection. The primary endpoint was hospitalization for heart failure (HF) or death, and the secondary endpoint was death over 2 years after CRT.
RESULTS


In all patients, high longitudinal SSI (≥ group median of 3.1%) was significantly associated with freedom from the primary endpoint of HF hospitalization or death (hazard ratio [HR] for low SSI: 2.17; 95% confidence interval [CI]: 1.45 to 3.24, p < 0.001) and secondary endpoint of death (HR for low SSI: 4.06; 95% CI: 1.95 to 8.45, p < 0.001). Among the 203 patients with QRS 120 to 149 ms or non-LBBB, those with high longitudinal SSI (≥ group median of 2.6%) had significantly fewer HF hospitalizations or deaths (HR for low SSI: 2.08; 95% CI: 1.27 to 3.41, p = 0.004) and longer survival (HR for low SSI: 5.08; 95% CI: 1.94 to 13.31, p < 0.001), similar to patients with LBBB ≥150 ms. SSI by circumferential strain had similar associations with clinical outcomes, and GLS was additive to SSI in predicting clinical events (p = 0.001).
CONCLUSIONS


Systolic stretch by strain imaging characterized the myocardial substrate associated with favorable CRT response, including in the important patient subgroup with QRS width 120 to 149 ms or non-LBBB. GLS had additive prognostic value.",2019,"SSI by circumferential strain had similar associations with clinical outcomes, and GLS was additive to SSI in predicting clinical events (p = 0.001).
","['442 patients enrolled in the Adaptive CRT 94-site randomized trial with New York Heart Association functional class III-IV heart failure, ejection fraction\xa0≤35%, and QRS\xa0≥120 ms', 'patients with QRS width 120 to 149 ms or non-left bundle branch block (LBBB), where clinical uncertainty for CRT exists', '203 patients with QRS']",['cardiac resynchronization therapy (CRT'],"['secondary endpoint of death', 'HF hospitalization or death', 'HF hospitalizations or deaths', 'hospitalization for heart failure (HF) or death, and the secondary endpoint was death over 2 years after\xa0CRT', 'systolic stretch index (SSI', 'longer survival', 'Systolic stretch']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441887', 'cui_str': 'Class 3 (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0006384', 'cui_str': 'Bundle-Branch Block'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",442.0,0.0799423,"SSI by circumferential strain had similar associations with clinical outcomes, and GLS was additive to SSI in predicting clinical events (p = 0.001).
","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gorcsan', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri. Electronic address: gorcsan@wustl.edu.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Anderson', 'Affiliation': 'Biostatistics Group, Medtronic Incorporated, Minneapolis, Minnesota.'}, {'ForeName': 'Bhupendar', 'Initials': 'B', 'LastName': 'Tayal', 'Affiliation': 'The University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Sugahara', 'Affiliation': 'The University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Walmsley', 'Affiliation': 'CARIM School for Cardiovascular Diseases, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'The Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Lumens', 'Affiliation': ""CARIM School for Cardiovascular Diseases, Maastricht University Medical Center, Maastricht, the Netherlands; L'Institut de Rythmologie et Modélisation Cardiaque (IHU-LIRYC), Université de Bordeaux, Pessac, France.""}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2018.07.013']
1830,27216875,Process Evaluation of Making HEPA Policy Practice: A Group Randomized Trial.,"This study examines the link between implementation of Strategies to Enhance Practice (STEPs) and outcomes. Twenty after-school programs (ASPs) participated in an intervention to increase children's accumulation of 30 minutes/day of moderate to vigorous physical activity (MVPA) and quality of snacks served during program time. Outcomes were measured via accelerometer (MVPA) and direct observation (snacks). STEPs implementation data were collected via document review and direct observation. Based on implementation data, ASPs were divided into high/low implementers. Differences between high/low implementers' change in percentage of boys accumulating 30 minutes/day of MVPA were observed. There was no difference between high/low implementers for girls. Days fruits and/or vegetables and water were served increased in the high/low implementation groups, while desserts and sugar-sweetened beverages decreased. Effect sizes (ES) for the difference in changes between the high and low group ranged from low (ES = 0.16) to high (ES = 0.97). Higher levels of implementation led to increased MVPA for boys, whereas girls MVPA benefited from the intervention regardless of high/low implementation. ESs of the difference between high/low implementers indicate that increased implementation of STEPs increases days healthier snacks are served. Programs in the high-implementation group implemented a variety of STEPs strategies, suggesting local adoption/adaptation is key to implementation.",2016,Differences between high/low implementers' change in percentage of boys accumulating 30 minutes/day of MVPA were observed.,[],[],"['via accelerometer (MVPA) and direct observation (snacks', 'vigorous physical activity (MVPA) and quality of snacks served during program time']",[],[],"[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0218382,Differences between high/low implementers' change in percentage of boys accumulating 30 minutes/day of MVPA were observed.,"[{'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Weaver', 'Affiliation': 'University of South Carolina, Columbia, SC, USA weaverrg@mailbox.sc.edu.'}, {'ForeName': 'Justin B', 'Initials': 'JB', 'LastName': 'Moore', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Huberty', 'Affiliation': 'Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Freedman', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Brie', 'Initials': 'B', 'LastName': 'Turner-McGrievy', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Beighle', 'Affiliation': 'University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Ward', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Pate', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Saunders', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Brazendale', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chandler', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Rahma', 'Initials': 'R', 'LastName': 'Ajja', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Kyryliuk', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Beets', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}]",Health promotion practice,['10.1177/1524839916647331']
1831,31676298,Evaluation of meaning of life and self-care agency in nursing care given to chronic obstructive pulmonary patients according to health promotion model.,"The study was conducted to evaluate the meaning of life and self-care agency in nursing care given to chronic obstructive pulmonary patients according to the health promotion model. The sample of the study was determined by power analysis and 40 COPD patients were assigned to each group by simple random sampling method. Descriptive Information Form, Life Attitude Profile and Self-care Agency Scale were used to obtain the data. Nursing care was applied by the researcher 3 times in every 2 weeks according to the health promotion model in the houses of the patients in the experimental groups. Number, percentage, mean, standard deviation, dependent samples t-test, independent samples t-test, chi-square and ANOVA were used to analyze the data. It was determined that while posttest mean score of the patients in the Experimental group 1 for Self-care agency scale was 112.70 ± 29.0; their posttest mean score for Life Attitude Profile was 156.37 ± 13.5. Posttest mean score of the patients in the Control group 1 for Self-care agency scale was 81.35 ± 17.7; whereas, their posttest mean score for Life Attitude Profile was 120.50 ± 31.9. The difference between the posttest mean scores of the groups was statistically significant (p < 0.05). The care applied to the patients with COPD according to health promotion model was found to increase self-care agency and meaning of life of the patients.",2020,The care applied to the patients with COPD according to health promotion model was found to increase self-care agency and meaning of life of the patients.,"['chronic obstructive pulmonary patients according to the health promotion model', '40 COPD patients', 'chronic obstructive pulmonary patients according to health promotion model']",[],"['Self-care agency scale', 'Life Attitude Profile and Self-care Agency Scale', 'meaning of life and self-care agency']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]",[],"[{'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0222045'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",40.0,0.0119538,The care applied to the patients with COPD according to health promotion model was found to increase self-care agency and meaning of life of the patients.,"[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Karasu', 'Affiliation': 'Kilis 7 Aralık University, Yusuf Şerefoğlu Faculty of Health Sciences, Department of Nursing, Kilis, Turkey. Electronic address: fatmakarasu@kilis.edu.tr.'}, {'ForeName': 'Rukuye', 'Initials': 'R', 'LastName': 'Aylaz', 'Affiliation': 'Inönü University, Faculty of Nursing, Malatya, Turkey. Electronic address: rukuye.aylaz@inonu.edu.tr.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2019.151208']
1832,31672177,Ticagrelor Alone Versus Dual Antiplatelet Therapy From 1 Month After Drug-Eluting Coronary Stenting.,"BACKGROUND


The GLOBAL LEADERS (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) study randomly assigned 15,991 patients undergoing percutaneous coronary intervention to 1-month dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy or conventional 12-month DAPT followed by 12-month aspirin. Apart from Q-wave myocardial infarction (MI), all study endpoints were analyzed as investigator reported.
OBJECTIVES


This was a pre-specified ancillary study assessing whether experimental therapy is noninferior, and if met, superior, to conventional treatment for the coprimary efficacy endpoint of all-cause death, nonfatal MI, nonfatal stroke, or urgent target vessel revascularization and superior in preventing BARC 3 (Bleeding Academic Research Consortium) or 5 bleeding (coprimary safety endpoint) at 2 years with a 0.025 significance level to preserve nominal 5% alpha error.
METHODS


An independent clinical event committee adjudicated investigator-reported and eventually unreported events of 7,585 patients from the 20 top-enrolling participating sites.
RESULTS


The 2-year coprimary efficacy endpoint occurred in 271 (7.14%) and in 319 (8.41%) patients in the experimental and conventional groups, respectively (rate ratio [RR]: 0.85; 95% confidence interval [CI]: 0.72 to 0.99), fulfilling noninferiority (p noninferiority <0.001), but not superiority (p superiority = 0.0465). The rates of BARC 3 or 5 bleeding did not differ (RR: 1.00; 95% CI: 0.75 to 1.33; p = 0.986). A time-dependent treatment effect was observed with the experimental strategy being associated with a lower risk of MI (RR: 0.54; 95% CI: 0.33 to 0.88; p interaction = 0.062) and definite stent thrombosis (RR: 0.14; 95% CI: 0.03 to 0.63; p interaction = 0.007) after 1-year post-percutaneous coronary intervention.
CONCLUSIONS


Ticagrelor monotherapy after 1-month DAPT was noninferior, but not superior, to conventional treatment in the prevention of ischemic events, and it did not decrease major bleeding risk as compared with conventional treatment. (GLOBAL LEADERS Adjudication Sub-Study [GLASSY]; NCT03231059).",2019,The rates of BARC 3 or 5 bleeding did not differ (RR: 1.00; 95% CI: 0.75 to 1.33; p = 0.986).,"['7,585 patients from the 20 top-enrolling participating sites', '15,991 patients undergoing']","['Ticagrelor Alone Versus Dual Antiplatelet Therapy', 'percutaneous coronary intervention to 1-month dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy or conventional 12-month DAPT followed by 12-month aspirin', 'Anti-platelet Therapy']","['2-year coprimary efficacy endpoint', 'cause death, nonfatal MI, nonfatal stroke, or urgent target vessel revascularization and superior in preventing BARC 3 (Bleeding Academic Research Consortium) or 5 bleeding', 'rates of BARC 3 or 5 bleeding', 'major bleeding risk', 'definite stent thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035168'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",,0.0569959,The rates of BARC 3 or 5 bleeding did not differ (RR: 1.00; 95% CI: 0.75 to 1.33; p = 0.986).,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Franzone', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Eugène', 'Initials': 'E', 'LastName': 'McFadden', 'Affiliation': 'Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands; Department of Cardiology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': 'University of Pavia and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Piccolo', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Belgium.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, Imperial College of London, London, United Kingdom.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Benit', 'Affiliation': 'Department of Cardiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Liebetrau', 'Affiliation': 'Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany; German Center for Cardiovascular Research (DZHK), partner site RheinMain, Frankfurt am Main, Germany.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Imelda Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Ferrario', 'Affiliation': 'University of Pavia and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Zurakowski', 'Affiliation': 'Department of Interventional Cardiology, American Heart of Poland SA, Chrzanów, Poland.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diletti', 'Affiliation': 'Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Dominici', 'Affiliation': 'S. Maria University-Hospital, Terni, Italy.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Medical Department, Cardiology, Wilhelminenhospital, and Sigmund Freud University Medical School, Vienna, Austria.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Slagboom', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'Center for Cardiovascular Research and Development, American Heart of Poland, Sanatoryjna 1, Ustroń, Poland; Department of Epidemiology and Statistics, Medical University of Silesia, Poniatowskiego 15, Katowice.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bolognese', 'Affiliation': 'Azienda Toscana Usl Sudest, Arezzo, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Tumscitz', 'Affiliation': ""Cardiology Unit Sant'Anna Hospital, Ferrara, Italy.""}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Bryniarski', 'Affiliation': 'Jagiellonian University Medical College, The John Paul II Hospital, Krakow, Poland.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Vrolix', 'Affiliation': 'Ziekenhuis Oost Limburg, Genk, Belgium.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Petrov', 'Affiliation': 'Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'East Lancashire Hospitals NHS Trust, Blackburn, United Kingdom.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Naber', 'Affiliation': 'Contilia Heart and Vascular Centre, Stadtspital Triemli, Zürich, Switzerland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Prokopczuk', 'Affiliation': 'Polsko-Amerykańskie Kliniki Serca Kozle, Kozle, Poland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), partner site RheinMain, Frankfurt am Main, Germany; Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Hôpital Bichat, AP-HP, Université Paris-Diderot, Paris, France.'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address: marco.valgimigli@insel.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.08.1038']
1833,30577050,Bipolar Sealers Do not Improve Blood Loss or Functional Outcomes of Primary Total Knee Arthroplasty.,"Several methods were introduced to limit perioperative blood loss in total knee arthroplasty (TKA). By transcollation of soft tissues below 100°C, bipolar sealers intend to reduce bleeding and tissue damage, compared with conventional electrocautery. Existing studies report contradictory findings about the performance of bipolar sealers. The purpose of this study was to evaluate the effect of a bipolar sealer on blood loss, transfusions, hospital length of stay (LOS), and functional scores in primary TKA. In this single-center prospective study, 101 patients, undergoing primary TKA in a fast-track setting without tourniquet use, were randomly assigned to either (1) the study group which was operated with a bipolar sealer or (2) the control group operated with conventional electrocautery. The study cohort comprised 49 men and 52 women, aged 71.1 ± 8.8 years. There was no significant difference between the bipolar sealer group and the control group in terms of blood loss at day 3 (1,240 ± 547.4 vs. 1,376 ± 584.4 mL;  p  = ns [not significant]), transfusion rate (10 vs. 4%;  p  = ns), surgery time (48.2 ± 10.8 vs. 46.6 ± 9.1 minute;  p  = ns) or LOS (4.1 ± 2.7 vs 4.3 ± 2.0 days;  p  = ns). At a mean follow-up of 63.3 ± 4.9 days, there was no significant difference between the bipolar sealer group and the control group in terms of net improvement of Knee Society Score (KSS) knee (26.0 ± 16.7 vs. 23.7 ± 12.3;  p  = ns) and KSS function (20.4 ± 19.3 vs. 20.8 ± 19.9;  p  = ns). Compared with the use of conventional electrocautery in primary TKA without tourniquet, we found no effect of bipolar sealer use on blood loss, transfusion rates, LOS, or functional recovery. This is a Level II, prospective cohort study.",2020,"There was no significant difference between the bipolar sealer group and the control group in terms of blood loss at day 3 (1,240 ± 547.4 vs. 1,376 ± 584.4 mL;  p  = ns [not significant]), transfusion rate (10 vs. 4%;  p  = ns), surgery time (48.2 ± 10.8 vs. 46.6 ± 9.1 minute;  p  = ns) or LOS (4.1 ± 2.7 vs 4.3 ± 2.0 days;  p  = ns).","['101 patients, undergoing primary TKA in a fast-track setting without tourniquet use', '49 men and 52 women, aged 71.1\u2009±\u20098.8 years', 'Primary Total Knee Arthroplasty', 'total knee arthroplasty (TKA']","['bipolar sealer', 'bipolar sealer or (2) the control group operated with conventional electrocautery', 'conventional electrocautery']","['Knee Society Score (KSS) knee', 'KSS function', 'blood loss', 'blood loss, transfusion rates, LOS, or functional recovery', 'surgery time', 'bleeding and tissue damage', 'blood loss, transfusions, hospital length of stay (LOS), and functional scores', 'transfusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0449942', 'cui_str': 'Sealer (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",101.0,0.100067,"There was no significant difference between the bipolar sealer group and the control group in terms of blood loss at day 3 (1,240 ± 547.4 vs. 1,376 ± 584.4 mL;  p  = ns [not significant]), transfusion rate (10 vs. 4%;  p  = ns), surgery time (48.2 ± 10.8 vs. 46.6 ± 9.1 minute;  p  = ns) or LOS (4.1 ± 2.7 vs 4.3 ± 2.0 days;  p  = ns).","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Pasqualotto', 'Affiliation': 'Department of Knee Surgery, Lyon-Ortho-Clinic, Lyon, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Demey', 'Affiliation': 'Department of Knee Surgery, Lyon-Ortho-Clinic, Lyon, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Michelet', 'Affiliation': 'Department of Research and Development, ReSurg SA, Nyon, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Nover', 'Affiliation': 'Department of Research and Development, ReSurg SA, Nyon, Switzerland.'}, {'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Saffarini', 'Affiliation': 'Department of Research and Development, ReSurg SA, Nyon, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dejour', 'Affiliation': 'Department of Knee Surgery, Lyon-Ortho-Clinic, Lyon, France.'}]",The journal of knee surgery,['10.1055/s-0038-1676516']
1834,30544227,In the Eyes of Those Who Were Randomized: Perceptions of Disadvantaged Older Adults in a Tai Chi Trial.,"BACKGROUND AND OBJECTIVES


Older adults living in subsidized housing have typically been excluded from exercise intervention studies. We conducted a qualitative study to explore the perceived physical, psychological, social, and economic factors that influenced participation in and adherence to a year-long Tai Chi intervention within an ongoing cluster-randomized controlled trial (RCT) for older adults living within subsidized housing facilities.
RESEARCH DESIGN AND METHODS


Focus groups were held with participants of the RCT who were allocated to the trial's Tai Chi intervention. Individual phone interviews were conducted with those allocated to Tai Chi who had low adherence or who had withdrawn their participation from the study. Emergent themes were extracted using grounded-theory methods.
RESULTS


In this qualitative study, we enrolled 41 participants who were allocated to the RCT's Tai Chi intervention: 38 completed and 3 withdrew from the study. Average Tai Chi class attendance was 64.3%. Pragmatic factors that led to higher adherence and retention included: locating classes within each facility; providing programs at no cost; and deployment of a skilled research support team. In addition, the use of an accessible, simplified Tai Chi program improved confidence, social support, self-efficacy, and self-reported improvements in physical and psychological well-being.
DISCUSSION AND IMPLICATIONS


Perceived physical, psychological, social benefits, and self-efficacy likely enhance adherence and retention to research-based Tai Chi interventions for older adults. Delivering an on-site, no cost, and supportive program appears critical to overcoming financial and environmental barriers to participation for those living within subsidized housing.",2020,"In addition, the use of an accessible, simplified Tai Chi program improved confidence, social support, self-efficacy, and self-reported improvements in physical and psychological well-being.
","['Individual phone interviews were conducted with those allocated to Tai Chi who had low adherence or who had withdrawn their participation from the study', 'older adults living within subsidized housing facilities', 'older adults', 'Disadvantaged Older Adults', ""41 participants who were allocated to the RCT's Tai Chi intervention: 38 completed and 3 withdrew from the study"", 'Older adults living in subsidized housing']",[],"['confidence, social support, self-efficacy, and self-reported improvements in physical and psychological well-being', 'Average Tai Chi class attendance']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",[],"[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0037438'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",41.0,0.0925067,"In addition, the use of an accessible, simplified Tai Chi program improved confidence, social support, self-efficacy, and self-reported improvements in physical and psychological well-being.
","[{'ForeName': 'On-Yee', 'Initials': 'OY', 'LastName': 'Lo', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Conboy', 'Affiliation': 'New England School of Acupuncture, Newton, Massachusetts.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rukhadze', 'Affiliation': 'New England School of Acupuncture, Newton, Massachusetts.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Georgetti', 'Affiliation': 'New England School of Acupuncture at Massachusetts College of Pharmacy and Health Sciences, Worcester, Massachusetts.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Gagnon', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Manor', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Margie E', 'Initials': 'ME', 'LastName': 'Lachman', 'Affiliation': 'Department of Psychology, Brandeis University, Waltham, Massachusetts.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}]",The Gerontologist,['10.1093/geront/gny165']
1835,31090746,Immediate fixed rehabilitation of severe maxillary atrophies using trans-sinus tilted implants with or without sinus bone grafting: One-year results from a randomised controlled trial.,"BACKGROUND


To compare the clinical outcomes between tilted trans-sinus implants inserted without simultaneous bone grafting versus sinus elevation procedures with bone grafting to support immediately loaded prostheses for the rehabilitation of the atrophic maxilla.
MATERIALS AND METHODS


Thirty-two subjects were selected to receive an immediately loaded fixed restoration supported by four or six implants and randomised to receive at least one trans-sinus implant without simultaneous bone grafting (group 1, n = 16) or at least one trans-sinus implant with sinus elevation procedures and bone grafting (group 2, n = 16). Primary outcomes were prosthesis and implant failures. Secondary outcomes were complications and peri-implant marginal bone level changes.
RESULTS


Forty-one trans-sinus implants (23 trans-sinus implants without simultaneous bone-grafting and 18 trans-sinus implants with sinus elevation procedures), 23 conventional tilted implants and 84 axial implants were inserted. No drop-outs occurred. At 1 year after loading no prosthesis was lost. One patient treated with sinus graft lost one implant (0.0% vs. 6.3%, difference 6.3%; 95% CI: -4.7 to 17.3; P = 0.99). There were no statistically significant differences in implant failures between the two groups. Complications occurred in eight patients in the group without bone grafting and in nine patients in the group with sinus elevation and bone augmentation. No statistically significant differences were found in complications (50.0% vs. 56.3%, difference 6.3%; 95% CI: -12.7 to 25.3; P = 0.99), and in peri-implant marginal bone level changes (difference 0.05 mm; 95% CI: -0.24 to 0.34; P = 0.604).
CONCLUSIONS


In this study, no statistically significant differences were observed between subjects treated with tilted trans-sinus implants without simultaneous bone-grafting or with sinus elevation procedures supporting cross-arch immediately loaded fixed prostheses in atrophic maxillae. Longer follow-ups are needed and alternative procedures such us short implants or crestal sinus elevation procedures should be compared since they could be less invasive.",2019,Complications occurred in eight patients in the group without bone grafting and in nine patients in the group with sinus elevation and bone augmentation.,"['Forty-one trans-sinus implants (23 trans-sinus implants without simultaneous bone-grafting and 18 trans-sinus implants with sinus elevation procedures), 23 conventional tilted implants and 84 axial implants', 'Thirty-two subjects were selected to receive an']","['trans-sinus tilted implants with or without sinus bone grafting', 'tilted trans-sinus implants inserted without simultaneous bone grafting versus sinus elevation procedures with bone grafting to support immediately loaded prostheses', 'immediately loaded fixed restoration supported by four or six implants and randomised to receive at least one trans-sinus implant without simultaneous bone grafting (group 1, n = 16) or at least one trans-sinus implant with sinus elevation procedures and bone grafting']","['complications and peri-implant marginal bone level changes', 'prosthesis and implant failures', 'implant failures', 'peri-implant marginal bone level changes', 'Complications', 'complications']","[{'cui': 'C0558141', 'cui_str': 'Transsexual (finding)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0558141', 'cui_str': 'Transsexual (finding)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0524929', 'cui_str': 'Prosthetic Implants'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0854676', 'cui_str': 'Failure of implant'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",32.0,0.104533,Complications occurred in eight patients in the group without bone grafting and in nine patients in the group with sinus elevation and bone augmentation.,"[{'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Grandi', 'Affiliation': ''}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Faustini', 'Affiliation': ''}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Casotto', 'Affiliation': ''}, {'ForeName': 'Rawad', 'Initials': 'R', 'LastName': 'Samarani', 'Affiliation': ''}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Svezia', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Radano', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1836,31116185,On the role of keratinised mucosa at dental implants: a 5-year prospective single-cohort study.,"PURPOSE


The purpose of this study was to evaluate the role of keratinised mucosa on the long-term success of dental implants.
MATERIALS AND METHODS


Thirty-two edentulous patients had one of their dental arches rehabilitated with a provisional screw-retained resin reinforced cross-arch fixed prosthesis supported by four immediately loaded implants. The two central straight implants were randomly allocated in two equal groups, according to a parallel-group design, to receive or not intermediate abutments (Multi-Unit Abutment, MUA). However, for the purpose of the present publication, the study was considered as a prospective single cohort study. To be immediately loaded, implants had to be inserted with a minimum torque of 30 Ncm, which was achieved by all implants. Provisional prostheses were delivered within 24 hours and were replaced, after 4 months, by definitive screw-retained metal-ceramic prostheses. Patients were followed up to 5 years after loading. Prostheses were removed every 8 months to facilitate professionally delivered maintenance. Outcome measures were prosthesis and implant failures, complications, peri-implant marginal bone level (MBL) changes, bleeding on probing (BoP) and keratinised mucosa height (KMH). The absence of vestibular or lingual keratinised mucosa was put in relation with peri-implant bone loss and BoP.
RESULTS


Five-years after loading two patients dropped out and no implant or prosthetic failure occurred. Four patients were affected by prosthetic complications. At delivery of definitive prostheses, 32 (25%) implants had at least one vestibular or lingual site with no KMH and 96 (75%) implants had both sites with some KMH. Multi-level models did not show any statistically significant association between KMH at the time of delivery of the definitive prosthesis and changes in MBL and BoP at 5 years (estimate = 0.02; 95% CI: -0.02 to 0.05; P = 0.3393; and 1.02; 95% CI: 0.79 to 1.33; P = 0.8695, respectively). When KMH was analysed as dichotomous variable, implants with presence of KMH at delivery of definitive prosthesis at both vestibular and lingual aspects showed a trend of less BoP (estimate = -0.8; 95% CI: -1.69 to 0.08; P = 0.0741) but a statistically significant greater MBL loss compared to implants where KMH was only present at one site (estimate = 0.18; 95% CI: -0.1 to 0.3; P = 0.0041).
CONCLUSIONS


The 5-year after loading outcome of immediately loaded screw-retained cross-arch prostheses supported by four implants is excellent in both the maxilla and mandible. Although the height of the keratinised mucosa did not seem to alter the clinical outcomes, its presence both at vestibular and lingual sites was associated with an increased marginal bone loss when compared to implants having at least one side without keratinised mucosa.",2019,"The absence of vestibular or lingual keratinised mucosa was put in relation with peri-implant bone loss and BoP.
RESULTS


Five-years after loading two patients dropped out and no implant or prosthetic failure occurred.","['Thirty-two edentulous patients had one of their dental arches rehabilitated with a provisional screw-retained resin reinforced cross-arch fixed prosthesis supported by four immediately loaded implants', 'two central straight implants']",['immediately loaded screw-retained cross-arch prostheses'],"['marginal bone loss', 'prosthesis and implant failures, complications, peri-implant marginal bone level (MBL) changes, bleeding on probing (BoP) and keratinised mucosa height (KMH', 'MBL loss']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011325', 'cui_str': 'Dental Arch'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}]","[{'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0524929', 'cui_str': 'Prosthetic Implants'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}]",32.0,0.072747,"The absence of vestibular or lingual keratinised mucosa was put in relation with peri-implant bone loss and BoP.
RESULTS


Five-years after loading two patients dropped out and no implant or prosthetic failure occurred.","[{'ForeName': 'Marzio', 'Initials': 'M', 'LastName': 'Todisco', 'Affiliation': ''}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Buti', 'Affiliation': ''}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Sbricoli', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Esposito', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1837,31116186,Five-year results from a randomised controlled trial comparing prostheses supported by 5-mm long implants or by longer implants in augmented bone in posterior atrophic edentulous jaws.,"PURPOSE


To evaluate whether 5-mm short dental implants could be an alternative to augmentation with anorganic bovine bone and placement of at least 10-mm long implants in posterior atrophic jaws.
MATERIALS AND METHODS


Fifteen patients with bilateral atrophic mandibles (5 to 7 mm bone height above the mandibular canal) and 15 patients with bilateral atrophic maxillae (4 to 6 mm bone height below the maxillary sinus), and bone thickness of at least 8 mm, were randomised according to a split-mouth design to receive one to three 5-mm short implants or at least 10-mm long implants in augmented bone. Mandibles were vertically augmented with interpositional bone blocks and maxillary sinuses with particulated bone via a lateral window. Implants were placed after 4 months, submerged and loaded, after another 4 months, with provisional prostheses. Four months later, definitive provisionally cemented prostheses were delivered. Outcome measures were: prosthesis and implant failures, any complication and peri-implant marginal bone level changes.
RESULTS


In five augmented mandibles the planned 10-mm long implants could not be placed and shorter implants (7.0 and 8.5 mm) had to be used instead. Five years after loading, six patients, five treated in the mandible and one in the maxilla, dropped out. Three prostheses (one mandibular and two maxillary) failed in the short-implant group versus none in the long-implant group. In mandibles one long implant failed versus two short implants in one patient. In maxillae one long implant failed versus three short implants in two patients. There were no statistically significant differences in implant (n = 26; P = 1.00, difference = 3.85%, 95% CI: -12.95% to 20.64%) and prosthetic (n = 26; P = 0.250, difference = 11.54%, 95% CI: -0.74% to 23.82%) failures. Eleven patients had 16 complications at short implants (one patient accounted for six complications) and 12 patients had 14 complications at long implants. There were no statistically significant differences in complications (n = 28; P = 1.00, difference = -3.57%, 95% CI: -30.65% to 23.51%). Five years after loading, patients with mandibular implants lost on average 1.72 mm at short implants and 2.10 mm at long implants of peri-implant marginal bone. This difference was statistically significant (difference = 0.37 ± 0.43 mm; 95% CI: 0.07 to 0.68 mm; P = 0.022). In maxillae, patients lost on average 1.31 mm at short implants and 1.79 mm at long implants. This difference was statistically significant (difference = 0.48 ± 0.43 mm; 95% CI: 0.22 to 0.74 mm; P = 0.002).
CONCLUSIONS


Five years after loading, 5-mm short implants achieved similar results to longer implants in augmented bone. The choice of short implants might be preferable to vertical bone augmentation, especially in mandibles, since the treatment is faster and cheaper.",2019,"There were no statistically significant differences in complications (n = 28; P = 1.00, difference = -3.57%, 95% CI: -30.65% to 23.51%).","['posterior atrophic edentulous jaws', 'Fifteen patients with bilateral atrophic mandibles (5 to 7 mm bone height above the mandibular canal) and 15 patients with bilateral atrophic maxillae (4 to 6 mm bone height below the maxillary sinus), and bone thickness of at least 8 mm']",['split-mouth design to receive one to three 5-mm short implants or at least 10-mm long implants in augmented bone'],"['prosthesis and implant failures, any complication and peri-implant marginal bone level changes', 'complications']","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0022366', 'cui_str': 'Jaw, Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0024687', 'cui_str': 'Mandible'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0222756', 'cui_str': 'Structure of mandibular canal'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C0024957', 'cui_str': 'Maxillary Antrum'}]","[{'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]","[{'cui': 'C0524929', 'cui_str': 'Prosthetic Implants'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",15.0,0.378031,"There were no statistically significant differences in complications (n = 28; P = 1.00, difference = -3.57%, 95% CI: -30.65% to 23.51%).","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Felice', 'Affiliation': ''}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Barausse', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pistilli', 'Affiliation': ''}, {'ForeName': 'Daniela Rita', 'Initials': 'DR', 'LastName': 'Ippolito', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Esposito', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1838,31740017,Cardiovascular Effects of Switching From Tobacco Cigarettes to Electronic Cigarettes.,"BACKGROUND


E-cigarette (EC) use is increasing exponentially worldwide. The early cardiovascular effects of switching from tobacco cigarettes (TC) to EC in chronic smokers is unknown. Meta-analysis of flow-mediated dilation (FMD) studies indicate 13% lower pooled, adjusted relative risks of cardiovascular events with every 1% improvement in FMD.
OBJECTIVES


This study sought to determine the early vascular impact of switching from TC to EC in chronic smokers.
METHODS


The authors conducted a prospective, randomized control trial with a parallel nonrandomized preference cohort and blinded endpoint of smokers ≥18 years of age who had smoked ≥15 cigarettes/day for ≥2 years and were free from established cardiovascular disease. Participants were randomized to EC with nicotine or EC without nicotine for 1 month. Those unwilling to quit continued with TC in a parallel preference arm. A propensity score analysis was done to adjust for differences between the randomized and preference arms. Vascular function was assessed by FMD and pulse wave velocity. Compliance with EC was measured by carbon monoxide levels.
RESULTS


Within 1 month of switching from TC to EC, there was a significant improvement in endothelial function (linear trend β = 0.73%; 95% confidence interval [CI]: 0.41 to 1.05; p < 0.0001; TC vs. EC combined: 1.49%; 95% CI: 0.93 to 2.04; p < 0.0001) and vascular stiffness (-0.529 m/s; 95% CI: -0.946 to -0.112; p = 0.014). Females benefited from switching more than males did in every between-group comparison. Those who complied best with EC switch demonstrated the largest improvement. There was no difference in vascular effects between EC with and without nicotine within the study timeframe.
CONCLUSIONS


TC smokers, particularly females, demonstrate significant improvement in vascular health within 1 month of switching from TC to EC. Switching from TC to EC may be considered a harms reduction measure. (Vascular Effects of Regular Cigarettes Versus Electronic Cigarette Use [VESUVIUS]; NCT02878421; ISRCTN59133298).",2019,"There was no difference in vascular effects between EC with and without nicotine within the study time frame.
","['chronic smokers', 'smokers ≥18 years of age who had smoked\xa0≥15 cigarettes/day for\xa0≥2 years and were free from established cardiovascular disease']","['EC with nicotine or EC without nicotine', 'Regular Cigarettes', 'switching from tobacco cigarettes (TC) to EC', 'TC to EC']","['vascular health', 'vascular stiffness', 'vascular effects', 'Vascular function', 'endothelial function']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.133449,"There was no difference in vascular effects between EC with and without nicotine within the study time frame.
","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom. Electronic address: j.george@dundee.ac.uk.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Thenmalar', 'Initials': 'T', 'LastName': 'Vadiveloo', 'Affiliation': 'Population Health and Genomics Division, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Ireland', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Hopkinson', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'Population Health and Genomics Division, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Faisel', 'Initials': 'F', 'LastName': 'Khan', 'Affiliation': 'Division of Systems Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}, {'ForeName': 'Chim C', 'Initials': 'CC', 'LastName': 'Lang', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.067']
1839,30608607,B-Sure: a randomized pilot trial of an interactive web-based decision support aid versus usual care in average-risk breast cancer patients considering contralateral prophylactic mastectomy.,"The use of contralateral prophylactic mastectomy (CPM) is increasing among breast cancer patients who are at average or ""sporadic"" risk for contralateral breast cancer. Because CPM provides no survival benefit for these patients, it is not medically recommended for them. Decision support aids may facilitate more informed, higher quality CPM decision. The purpose of this study was to evaluate the feasibility and acceptability of B-Sure, an online decision support aid to facilitate informed decisions regarding CPM, and to compare the impact of B-Sure in increasing CPM knowledge, reducing decisional conflict, and increasing preparedness to make the CPM decision among breast cancer patients at sporadic risk who are considering CPM. Ninety-three patients with unilateral, nonhereditary breast cancer considering CPM completed a baseline survey, were randomized to receive B-Sure or Usual care, and completed a 4-week follow-up survey assessing decisional conflict, preparedness to make the CPM decision, and CPM knowledge as well as self-efficacy, perceived risk, worry, CPM motivations, and the surgical decision. Study participation was high. B-Sure was viewed by almost 80% of the participants and was evaluated positively. At follow-up, patients assigned to B-Sure reported significantly higher clarity regarding the personal values relevant to the CPM decision and higher knowledge about CPM. B-Sure had smaller effects on other aspects of decisional conflict. B-Sure improved CPM knowledge and reduced decisional conflict. Patients considering CPM may benefit from an online decision support aid, but may be sensitive to approaches that they perceive as biased against CPM.",2020,B-Sure had smaller effects on other aspects of decisional conflict.,"['breast cancer patients who are at average or ""sporadic"" risk for contralateral breast cancer', 'breast cancer patients at sporadic risk who are considering CPM', 'Ninety-three patients with unilateral, nonhereditary breast cancer considering CPM completed a baseline survey', 'average-risk breast cancer patients considering contralateral prophylactic mastectomy']","['interactive web-based decision support aid versus usual care', 'B-Sure or Usual care', 'contralateral prophylactic mastectomy (CPM']","['feasibility and acceptability of B', 'CPM knowledge and reduced decisional conflict', 'survival benefit']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205422', 'cui_str': 'Sporadic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1096616', 'cui_str': 'Contralateral breast cancer'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C1705768'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C1705768'}, {'cui': 'C0392412', 'cui_str': 'cpm'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",93.0,0.024215,B-Sure had smaller effects on other aspects of decisional conflict.,"[{'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Manne', 'Affiliation': 'Department of Medicine, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Smith', 'Affiliation': 'Department of Surgery, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Frederick', 'Affiliation': 'Department of Medicine, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mitarotondo', 'Affiliation': 'Department of Medicine, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Kashy', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Kirstein', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby133']
1840,30336170,Comparison of high-flow nasal cannula versus oxygen face mask for environmental bacterial contamination in critically ill pneumonia patients: a randomized controlled crossover trial.,"Whereas high-flow nasal cannula use is gaining prevalence, its high gas flow raises concerns about aerosolization of infectious particles and spread of infection. This randomized controlled crossover non-inferiority trial (N = 20) evaluated the degree of environmental contamination by viable bacteria associated with the use of high-flow nasal cannula compared with conventional oxygen mask for critically ill patients with Gram-negative pneumonia. The results show that high-flow nasal cannula use was not associated with increased air or contact surface contamination by either Gram-negative bacteria or total bacteria, suggesting that additional infection control measures are not required.",2019,"The results show that high-flow nasal cannula use was not associated with increased air or contact surface contamination by either Gram-negative bacteria or total bacteria, suggesting that additional infection control measures are not required.","['critically ill patients with Gram-negative pneumonia', 'critically ill pneumonia patients']","['high-flow nasal cannula versus oxygen face mask', 'high-flow nasal cannula compared with conventional oxygen mask']",[],"[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0854248', 'cui_str': 'Pneumonia caused by Gram negative bacteria (disorder)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0180823', 'cui_str': 'Face mask (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0181744', 'cui_str': 'Oxygen mask (physical object)'}]",[],,0.044912,"The results show that high-flow nasal cannula use was not associated with increased air or contact surface contamination by either Gram-negative bacteria or total bacteria, suggesting that additional infection control measures are not required.","[{'ForeName': 'C C H', 'Initials': 'CCH', 'LastName': 'Leung', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Joynt', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong. Electronic address: gavinmjoynt@cuhk.edu.hk.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Gomersall', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Wong', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ling', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'P K S', 'Initials': 'PKS', 'LastName': 'Chan', 'Affiliation': 'Department of Microbiology, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'P C W', 'Initials': 'PCW', 'LastName': 'Lui', 'Affiliation': 'Department of Pathology, Union Hospital, Hong Kong.'}, {'ForeName': 'P C Y', 'Initials': 'PCY', 'LastName': 'Tsoi', 'Affiliation': 'Department of Pathology, Union Hospital, Hong Kong.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Ling', 'Affiliation': 'Department of Microbiology, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hui', 'Affiliation': 'Department of Microbiology, The Chinese University of Hong Kong, Hong Kong.'}]",The Journal of hospital infection,['10.1016/j.jhin.2018.10.007']
1841,28456387,Erythropoietin and Brain Magnetic Resonance Imaging Findings in Hypoxic-Ischemic Encephalopathy: Volume of Acute Brain Injury and 1-Year Neurodevelopmental Outcome.,"In the Neonatal Erythropoietin and Therapeutic Hypothermia Outcomes study, 9/20 erythropoietin-treated vs 12/24 placebo-treated infants with hypoxic-ischemic encephalopathy had acute brain injury. Among infants with acute brain injury, the injury volume was lower in the erythropoietin than the placebo group (P = .004). Higher injury volume correlated with lower 12-month neurodevelopmental scores.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01913340.",2017,"Among infants with acute brain injury, the injury volume was lower in the erythropoietin than the placebo group (P = .004).","['treated infants with hypoxic-ischemic encephalopathy had acute brain injury', 'Hypoxic-Ischemic Encephalopathy']","['Erythropoietin and Brain Magnetic Resonance Imaging Findings', 'placebo', 'erythropoietin-treated vs 12/24 placebo']",['injury volume'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic-Ischemic Encephalopathy'}, {'cui': 'C0085742', 'cui_str': 'Injuries, Acute Brain'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.296562,"Among infants with acute brain injury, the injury volume was lower in the erythropoietin than the placebo group (P = .004).","[{'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Mulkey', 'Affiliation': ""Division of Fetal and Transitional Medicine, Children's National Health System, Washington, DC; University of Arkansas for Medical Sciences, Little Rock, AR. Electronic address: sbmulkey@childrensnational.org.""}, {'ForeName': 'Raghu H', 'Initials': 'RH', 'LastName': 'Ramakrishnaiah', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'McKinstry', 'Affiliation': 'Washington University, St. Louis, MO.'}, {'ForeName': 'Taeun', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': ""Division of Fetal and Transitional Medicine, Children's National Health System, Washington, DC.""}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Mathur', 'Affiliation': 'Washington University, St. Louis, MO.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Krisa P', 'Initials': 'KP', 'LastName': 'Van Meurs', 'Affiliation': 'Stanford University, Palo Alto, CA.'}, {'ForeName': 'G Bradley', 'Initials': 'GB', 'LastName': 'Schaefer', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Chunqiao', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Yvonne W', 'Initials': 'YW', 'LastName': 'Wu', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2017.03.053']
1842,31535100,Single crowns in the resorbed posterior maxilla supported by either 11-mm implants combined with sinus floor elevation or 6-mm implants:A 5-year randomised controlled trial.,"PURPOSE


To assess the clinical performance of single crowns in the posterior maxilla supported by either 11-mm-long implants combined with maxillary sinus floor elevation surgery or 6-mm-long implants during a 5-year follow-up period.
MATERIALS AND METHODS


A total of 38 consecutive patients, missing a premolar or a molar in the posterior maxilla and residual bone height underneath the maxillary sinus between 6 to 8 mm, were included. Subjects were randomly allocated to receive one 11-mm-long implant in combination with maxillary sinus floor augmentation or to receive one 6-mm-long implant without any grafting. A total of 41 implants (21 implants in 20 patients in the 6-mm group, and 20 implants in 18 patients in the 11-mm group) were placed and subsequently restored after 3 months with custom-made titanium abutments and cemented zirconia-based porcelain crowns. Both groups were followed by clinical (implant survival, restoration survival, complications, pocket probing depth and presence of plaque, calculus, bleeding and peri-implant inflammation) and radiographic examinations up to 5 years. The patient satisfaction was scored before treatment, and 12 and 60 months after functional implant restoration.
RESULTS


One patient (11-mm group) died before the 12-month evaluation and one patient (6-mm group) moved away. In addition, one patient in the 6-mm group lost one implant and no implants were lost in the 11-mm group. Two patients lost three restorations in the 6-mm group and no restorations were lost in the 11-mm group. From loading until the 60-month assessment, the mean marginal bone loss in the 6-mm group and the 11-mm group was 0.12 ± 0.36 mm and 0.14 ± 0.63 mm, respectively, without a significant difference (mean difference 0.02 mm; 95% CI -0.32 to 0.37; P = 0.884). Implant loss, restoration loss, screw loosening and porcelain chipping were defined as complications. Four patients in the 6-mm group and one patient in the 11-mm group had one or more complications, without a significant difference between the groups (95% CI 0.019 to 0.244; P = 0.198). The patient satisfaction was high in both groups (mean overall satisfaction in the 6-mm and the 11-mm groups was 9.4 ± 0.8 and 9.2 ± 0.8, respectively; mean difference 0.2; 95% CI -0.33 to 0.76; P = 0.434).
CONCLUSIONS


Reconstructions performed using an 11-mm implant combined with maxillary sinus floor augmentation or a 6-mm implant in the resorbed posterior maxilla are equally successful in supporting a single restoration over 5 years.",2019,"The patient satisfaction was high in both groups (mean overall satisfaction in the 6-mm and the 11-mm groups was 9.4 ± 0.8 and 9.2 ± 0.8, respectively; mean difference 0.2; 95% CI -0.33 to 0.76; P = 0.434).
","['38 consecutive patients, missing a premolar or a molar in the posterior maxilla and residual bone height underneath the maxillary sinus between 6 to 8 mm, were included', '41 implants (21 implants in 20 patients in the 6-mm group, and 20 implants in 18 patients in the 11-mm group']","['11-mm-long implant in combination with maxillary sinus floor augmentation or to receive one 6-mm-long implant without any grafting', '11-mm-long implants combined with maxillary sinus floor elevation surgery or 6-mm-long implants', 'custom-made titanium abutments and cemented zirconia-based porcelain crowns']","['mean marginal bone loss', 'patient satisfaction', 'clinical (implant survival, restoration survival, complications, pocket probing depth and presence of plaque, calculus, bleeding and peri-implant inflammation) and radiographic examinations', 'Implant loss, restoration loss, screw loosening and porcelain chipping']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0024957', 'cui_str': 'Maxillary Antrum'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C3178819', 'cui_str': 'Maxillary Sinus Floor Augmentation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0024957', 'cui_str': 'Maxillary Antrum'}, {'cui': 'C0016249', 'cui_str': 'Floors'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011392', 'cui_str': 'Porcelain'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0333050', 'cui_str': 'Loosening (morphologic abnormality)'}, {'cui': 'C0011392', 'cui_str': 'Porcelain'}]",38.0,0.115451,"The patient satisfaction was high in both groups (mean overall satisfaction in the 6-mm and the 11-mm groups was 9.4 ± 0.8 and 9.2 ± 0.8, respectively; mean difference 0.2; 95% CI -0.33 to 0.76; P = 0.434).
","[{'ForeName': 'Felix Louis', 'Initials': 'FL', 'LastName': 'Guljé', 'Affiliation': ''}, {'ForeName': 'Gerry Maarten', 'Initials': 'GM', 'LastName': 'Raghoebar', 'Affiliation': ''}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Vissink', 'Affiliation': ''}, {'ForeName': 'Henny Johannes Aloysius', 'Initials': 'HJA', 'LastName': 'Meijer', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1843,31116188,Posterior atrophic jaws rehabilitated with prostheses supported by 6-mm-long 4-mm-wide implants or by longer implants in augmented bone. Five-year post-loading results from a within-person randomised controlled trial.,"PURPOSE


To evaluate whether 6-mm-long by 4-mm-wide dental implants could be an alternative to implants at least 10-mm long placed in bone augmented with bone substitutes in posterior atrophic jaws.
MATERIALS AND METHODS


A total of 20 patients with bilateral atrophic mandibles and 20 patients with bilateral atrophic maxillae, having 5 to 7 mm of bone height below the maxillary sinus or 6 to 8 mm above the mandibular canal, had their sides of the jaws randomly allocated according to a split-mouth design. They were allocated to receive one to three 6-mm-long and 4-mm-wide implants, or implants at least 10-mm long in augmented bone by two different surgeons in different centres. Mandibles were vertically augmented with interpositional equine bone blocks and resorbable barriers, and implants were placed 3 months later. Maxillary sinuses were augmented with particulated porcine bone via a lateral window and implants were placed simultaneously. All implants were submerged and loaded, after 4 months, with provisional prostheses. Four months later, definitive prostheses were delivered. Outcome measures were prosthesis and implant failures, any complication and radiographic peri-implant marginal bone level changes. The follow-up was 5 years after loading for all patients.
RESULTS


Eight patients (five treated in mandibles and three in maxillae) dropped out before the 5-year post-loading follow-up. Four short implants (two maxillary and two mandibular) affected by peri-implantitis failed together with their prostheses versus three mandibular prostheses which could not be placed on implants at least 10-mm long due to graft failures; one was associated with the loss of three implants because of infection. There were no statistically significant differences in implant (P = 1.0) and prosthesis failures (P = 1.0). In total, 19 complications occurred in 14 patients at augmented sites versus five complications in four patients with 6-mm-long implants (P = 0.118). More complications occurred at grafted sites both in mandibles (P = 0.727), and maxillae (P = 0.063), although the differences were not statistically significant. In mandibles, patients with 6-mm-long implants lost an average of 1.34 ± 0.35 mm of peri-implant bone at 5 years versus 2.11 ± 0.59 mm in patients with implants at least 10-mm long. The difference was statistically significant (mean difference = 0.77 ± 0.70 mm; 95% CI: 0.32 to 1.21 mm; P = 0.003). In maxillae, patients with 6-mm-long implants lost an average of 1.52 ± 0.47 mm of peri-implant bone at 5 years versus 1.85 ± 0.51 mm in patients with implants at least 10-mm long. The difference was statistically significant (mean difference = 0.33 ± 0.36 mm; 95% CI: 0.14 to 0.53 mm; P = 0.002).
CONCLUSIONS


Results at 5 years after loading indicate that 6-mm-long implants with a conventional diameter of 4 mm achieved similar results to longer implants placed in augmented bone. Short implants might be a preferable choice to bone augmentation, especially in posterior mandibles since the treatment was faster, cheaper and associated with less morbidity. However, 10-year post-loading data are necessary before making reliable recommendations.",2019,"More complications occurred at grafted sites both in mandibles (P = 0.727), and maxillae (P = 0.063), although the differences were not statistically significant.","['20 patients with bilateral atrophic mandibles and 20 patients with bilateral atrophic maxillae, having 5 to 7 mm of bone height below the maxillary sinus or 6 to 8 mm above the mandibular canal, had their sides of the jaws randomly allocated according to a split-mouth design']","['6-mm-long by 4-mm-wide dental implants', 'particulated porcine bone via a lateral window and implants were placed simultaneously']","['morbidity', 'More complications', 'prosthesis failures', 'prosthesis and implant failures, any complication and radiographic peri-implant marginal bone level changes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0024687', 'cui_str': 'Mandible'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0024957', 'cui_str': 'Maxillary Antrum'}, {'cui': 'C0222756', 'cui_str': 'Structure of mandibular canal'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0011373', 'cui_str': 'Dental Implants'}, {'cui': 'C0457784', 'cui_str': 'Particulate (finding)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0033586', 'cui_str': 'Prosthesis Failure'}, {'cui': 'C0524929', 'cui_str': 'Prosthetic Implants'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",20.0,0.298788,"More complications occurred at grafted sites both in mandibles (P = 0.727), and maxillae (P = 0.063), although the differences were not statistically significant.","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Felice', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pistilli', 'Affiliation': ''}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Barausse', 'Affiliation': ''}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Piattelli', 'Affiliation': ''}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Buti', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Esposito', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1844,31116190,Immediate loading of one (fixed-on-1) versus two (fixed-on-2) implants placed flapless supporting mandibular screw-retained cross-arch fixed prostheses: 10-month results from an explanatory randomised controlled trial.,"PURPOSE


To evaluate the outcome of one (fixed-on-1, Fo1) versus two (fixed-on-2, Fo2) implants placed flapless in fully edentulous mandibles and immediately restored with metal-resin screw-retained cross-arch prostheses.
MATERIALS AND METHODS


Twenty patients with edentulous or to be rendered edentulous mandibles were randomised to the Fo1 group (10 patients who received three intraforaminal implants but only the mesial implant was actually loaded) and to the Fo2 group (10 patients who received two intraforaminal implants) according to a parallel-group design. To be immediately loaded implants had to be inserted with a minimum torque of 60 Ncm. Outcome measures were prosthesis and implant failures, complications and patient satisfaction for function and aesthetics evaluated up to 10 months post-loading.
RESULTS


Flaps were raised in three patients of the Fo1 group and one of the Fo2 group. Two prostheses in each group were delayed loaded at 2 and 3 months, because implants could not be inserted with a torque superior to 60 Ncm. Patients of the Fo2 group received prostheses with 12 teeth whereas Fo1 patients with 8 or 10 teeth. Ten months after loading no drop-out or implant failure occurred, but one Fo2 prosthesis had to be remade because the patient complained it was too short (risk difference = 0.1; 95% CI: -0.19 to 0.40; Fisher's exact test P = 1.000). Three patients were affected by complications in each group (risk difference = 0.0; 95% CI: -0.359 to 0.359; Fisher's exact test; P = 1.000). There were no statistically significant differences for prosthetic failures and complications between groups. Four months after loading, patients of the Fo1 group were less satisfied for function than those of the Fo2 group (difference between the medians [Hodges-Lehmann estimation] = 1; 95% CI: 0 to 2; P = 0.043). No differences were observed for aesthetics (difference between the medians [Hodges-Lehmann estimation] = 0; 95% CI: -1 to 0; P = 0.481), and two Fo1 patients would not undergo the same procedure again (difference in proportions: 0.2; 95% CI: -0.11 to 0.51; P = 0.474).
CONCLUSIONS


Preliminary results suggest that immediately loaded cross-arch screw-retained fixed prostheses with 8 to 10 teeth can be supported by only one dental implant at least up to 10 months post-loading; however, the clinical application and usefulness of such a procedure remains questionable.",2019,"Four months after loading, patients of the Fo1 group were less satisfied for function than those of the Fo2 group (difference between the medians [Hodges-Lehmann estimation] = 1; 95% CI: 0 to 2; P = 0.043).","['fully edentulous mandibles and immediately restored with metal-resin screw-retained cross-arch prostheses', 'Twenty patients with edentulous or to be rendered edentulous mandibles']","['intraforaminal implants but only the mesial implant was actually loaded) and to the Fo2 group (10 patients who received two intraforaminal implants', 'Immediate loading of one (fixed-on-1) versus two (fixed-on-2) implants placed flapless supporting mandibular screw-retained cross-arch fixed prostheses']","['aesthetics', 'satisfied for function', 'prosthesis and implant failures, complications and patient satisfaction for function and aesthetics evaluated up to 10 months post-loading', 'prosthetic failures and complications', 'implant failure']","[{'cui': 'C3853359', 'cui_str': 'Edentulous mandible'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0549183', 'cui_str': 'Midline (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0524929', 'cui_str': 'Prosthetic Implants'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0854676', 'cui_str': 'Failure of implant'}]",3.0,0.145457,"Four months after loading, patients of the Fo1 group were less satisfied for function than those of the Fo2 group (difference between the medians [Hodges-Lehmann estimation] = 1; 95% CI: 0 to 2; P = 0.043).","[{'ForeName': 'Gioacchino', 'Initials': 'G', 'LastName': 'Cannizzaro', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Viola', 'Affiliation': ''}, {'ForeName': 'Daniela Rita', 'Initials': 'DR', 'LastName': 'Ippolito', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Esposito', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1845,30535860,Perceived duration of auditory oddballs: test of a novel pitch-window hypothesis.,"Unexpected oddball stimuli embedded within a series of otherwise identical standard stimuli tend to be overestimated in duration. The present study tested a pitch-window explanation of the auditory oddball effect on perceived duration in two experiments. For both experiments, participants listened to isochronous sequences consisting of a series of 400 Hz fixed-duration standard tones with an embedded oddball tone that differed in pitch and judged whether the variable-duration oddball was shorter or longer than the standard. Participants were randomly assigned to either a wide or narrow pitch-window condition, in which an anchor oddball was presented with high likelihood at either a far pitch (850 Hz) or a near pitch (550 Hz), respectively. In both pitch-window conditions, probe oddballs were presented with low likelihood at pitches that were either within or outside the frequency range established by the standard and anchor tones. Identical 700 Hz probe oddballs were perceived to be shorter in duration in the wide pitch-window condition than in the narrow pitch-window condition (Experiments 1 and 2), even when matching the overall frequency range of oddballs across conditions (Experiment 2). Results support the proposed pitch-window hypothesis, but are inconsistent with both enhanced processing and predictive coding accounts of the oddball effect.",2020,"Hz probe oddballs were perceived to be shorter in duration in the wide pitch-window condition than in the narrow pitch-window condition (Experiments 1 and 2), even when matching the overall frequency range of oddballs across conditions (Experiment 2).",['Identical 700'],"['novel pitch-window hypothesis', 'wide or narrow pitch-window condition, in which an anchor oddball was presented with high likelihood at either a far pitch (850\xa0Hz) or a near pitch']",['Perceived duration of auditory oddballs'],"[{'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}]","[{'cui': 'C0175681', 'cui_str': 'Pitch (observable entity)'}, {'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]",,0.0515572,"Hz probe oddballs were perceived to be shorter in duration in the wide pitch-window condition than in the narrow pitch-window condition (Experiments 1 and 2), even when matching the overall frequency range of oddballs across conditions (Experiment 2).","[{'ForeName': 'Elisa Kim', 'Initials': 'EK', 'LastName': 'Fromboluti', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI, 48824, USA.'}, {'ForeName': 'J Devin', 'Initials': 'JD', 'LastName': 'McAuley', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI, 48824, USA. dmcauley@msu.edu.'}]",Psychological research,['10.1007/s00426-018-1124-2']
1846,32408883,Neurally adjusted ventilatory assist versus pressure support ventilation: a randomized controlled feasibility trial performed in patients at risk of prolonged mechanical ventilation.,"BACKGROUND


The clinical effectiveness of neurally adjusted ventilatory assist (NAVA) has yet to be demonstrated, and preliminary studies are required. The study aim was to assess the feasibility of a randomized controlled trial (RCT) of NAVA versus pressure support ventilation (PSV) in critically ill adults at risk of prolonged mechanical ventilation (MV).
METHODS


An open-label, parallel, feasibility RCT (n = 78) in four ICUs of one university-affiliated hospital. The primary outcome was mode adherence (percentage of time adherent to assigned mode), and protocol compliance (binary-≥ 65% mode adherence). Secondary exploratory outcomes included ventilator-free days (VFDs), sedation, and mortality.
RESULTS


In the 72 participants who commenced weaning, median (95% CI) mode adherence was 83.1% (64.0-97.1%) and 100% (100-100%), and protocol compliance was 66.7% (50.3-80.0%) and 100% (89.0-100.0%) in the NAVA and PSV groups respectively. Secondary outcomes indicated more VFDs to D28 (median difference 3.0 days, 95% CI 0.0-11.0; p = 0.04) and fewer in-hospital deaths (relative risk 0.5, 95% CI 0.2-0.9; p = 0.032) for NAVA. Although overall sedation was similar, Richmond Agitation and Sedation Scale (RASS) scores were closer to zero in NAVA compared to PSV (p = 0.020). No significant differences were observed in duration of MV, ICU or hospital stay, or ICU, D28, and D90 mortality.
CONCLUSIONS


This feasibility trial demonstrated good adherence to assigned ventilation mode and the ability to meet a priori protocol compliance criteria. Exploratory outcomes suggest some clinical benefit for NAVA compared to PSV. Clinical effectiveness trials of NAVA are potentially feasible and warranted.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01826890. Registered 9 April 2013.",2020,"Secondary outcomes indicated more VFDs to D28 (median difference 3.0 days, 95% CI 0.0-11.0; p = 0.04) and fewer in-hospital deaths (relative risk 0.5, 95% CI 0.2-0.9; p = 0.032) for NAVA.","['patients at risk of prolonged mechanical ventilation', 'critically ill adults at risk of prolonged mechanical ventilation (MV', 'n\u2009=\u200978) in four ICUs of one university-affiliated hospital']","['RCT', 'neurally adjusted ventilatory assist (NAVA', 'NAVA versus pressure support ventilation (PSV', 'Neurally adjusted ventilatory assist versus pressure support ventilation', 'NAVA']","['hospital deaths', 'overall sedation', 'adherence', 'Richmond Agitation and Sedation Scale (RASS) scores', 'protocol compliance', 'mode adherence (percentage of time adherent to assigned mode), and protocol compliance (binary-≥\u200965% mode adherence', 'ventilator-free days (VFDs), sedation, and mortality', 'VFDs to D28', 'duration of MV, ICU or hospital stay, or ICU, D28, and D90 mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0277608', 'cui_str': 'Death in hospital'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0525058', 'cui_str': 'Protocol Compliance'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.234937,"Secondary outcomes indicated more VFDs to D28 (median difference 3.0 days, 95% CI 0.0-11.0; p = 0.04) and fewer in-hospital deaths (relative risk 0.5, 95% CI 0.2-0.9; p = 0.032) for NAVA.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Hadfield', 'Affiliation': ""Critical Care, King's College Hospital, London, UK. daniel.hadfield@nhs.net.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Rose', 'Affiliation': ""Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, UK.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Reid', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cornelius', 'Affiliation': 'Faculty of Medicine, School of Public Health, Imperial College, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hart', 'Affiliation': ""Centre for Human and Applied Physiological Sciences, King's College London, London, UK.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Finney', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Penhaligon', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Molai', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Noble', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Clarey', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Thompson', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Hopkins', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Gerrard F', 'Initials': 'GF', 'LastName': 'Rafferty', 'Affiliation': ""Centre for Human and Applied Physiological Sciences, King's College London, London, UK.""}]","Critical care (London, England)",['10.1186/s13054-020-02923-5']
1847,31116187,Posterior atrophic jaws rehabilitated with prostheses supported by 5 × 5 mm implants with a nanostructured calcium-incorporated titanium surface or by longer implants in augmented bone. Five-year results from a randomised controlled trial.,"PURPOSE


To evaluate whether 5 × 5 mm dental implants with a novel nanostructured calcium-incorporated titanium surface could be an alternative to implants at least 10-mm long placed in bone augmented with bone substitutes in posterior atrophic jaws.
MATERIALS AND METHODS


Forty patients with atrophic posterior (premolar and molar areas) mandibles having 5- to 7-mm bone height above the mandibular canal, and 40 patients with atrophic maxillae having 4- to 6-mm bone height below the maxillary sinus, were randomised according to a parallel-group design to receive one to three 5-mm implants or one to three at least 10-mm long implants in augmented bone at two centres. All implants had a diameter of 5 mm. Mandibles were vertically augmented with interpositional bovine bone blocks covered with resorbable barriers. Implants were placed after 4 months. Maxillary sinuses were augmented with particulated porcine bone via a lateral window covered with resorbable barriers and implants were placed simultaneously. All implants were submerged and loaded after 4 months with provisional prostheses. Four months later, definitive screw-retained or provisionally cemented metal-ceramic or zirconia prostheses were delivered. Patients were followed to 5 years post-loading and the outcome measures were: prosthesis and implant failures, any complication and peri-implant marginal bone level changes.
RESULTS


Sixteen patients dropped out before the 5-year evaluation (four short mandibles, three short maxillae, six augmented mandibles and three augmented maxillae). In mandibles, two grafted patients were not prosthetically rehabilitated because of multiple complications, and three implants failed in the same patient (one was a replacement implant) versus one patient who lost his short implant and crown 2 years after loading. In maxillae one short implant failed with its provisional crown 3 months post-loading. There were no statistically significant differences in prostheses (difference in proportion = -0.003; 95% CI: -0.14 to 0.13; P = 1.000) and implant failures (difference in proportion = -0.03; 95% CI: -0.17 to 0.09; P = 0.609) up to 5 years after loading. Significantly more complications occurred at mandibular grafted sites: 17 augmented patients were affected by complications versus nine patients treated with short implants in mandibles (difference in proportion = 0.39; 95% CI: 0.10 to 0.62; P = 0.013). In the maxilla seven sinus-elevated patients versus two patients treated with short implants were affected by complications, the difference not being statistically significant (difference in proportion = 0.25; 95% CI: -0.04 to 0.49; P = 0.128). Patients with mandibular short implants lost on average 1.22 mm of peri-implant bone at 5 years and patients with 10-mm or longer mandibular implants lost 1.70 mm. Patients with maxillary short implants lost on average 1.25 mm of peri-implant bone at 5 years and patients with 10-mm or longer maxillary implants lost 1.73 mm. Longer implants showed a greater bone loss up to 5 years after loading than short implants both in maxillae (mean difference: -0.48 mm; 95% CI: -0.89 to -0.07 mm; P = 0.024) and in mandibles (mean difference: -0.48 mm; 95% CI: -0.79 to -0.18 mm; P = 0.004).
CONCLUSIONS


Five years after loading, 5 × 5 mm implants achieved similar results to longer implants placed in augmented bone. Short implants might be a preferable choice to bone augmentation especially in posterior mandibles since the treatment is faster, cheaper and associated with less morbidity; however, 10-year post-loading data are necessary before making reliable recommendations.",2019,"Longer implants showed a greater bone loss up to 5 years after loading than short implants both in maxillae (mean difference: -0.48 mm; 95% CI: -0.89 to -0.07 mm; P = 0.024) and in mandibles (mean difference: -0.48 mm; 95% CI: -0.79 to -0.18 mm; P = 0.004).
","['Forty patients with atrophic posterior (premolar and molar areas) mandibles having 5- to 7-mm bone height above the mandibular canal, and 40 patients with atrophic maxillae having 4- to 6-mm bone height below the maxillary sinus', 'Patients with maxillary short implants lost on average 1.25 mm of peri-implant bone at 5 years and patients with 10-mm or longer maxillary implants lost 1.73 mm']","['particulated porcine bone via a lateral window covered with resorbable barriers and implants were placed simultaneously', 'definitive screw-retained or provisionally cemented metal-ceramic or zirconia prostheses']","['prosthesis and implant failures, any complication and peri-implant marginal bone level changes', 'bone loss', 'implant failures', 'complications', 'morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0024687', 'cui_str': 'Mandible'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0222756', 'cui_str': 'Structure of mandibular canal'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C0024957', 'cui_str': 'Maxillary Antrum'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C4517497', 'cui_str': '1.25 (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0457784', 'cui_str': 'Particulate (finding)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0524929', 'cui_str': 'Prosthetic Implants'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0854676', 'cui_str': 'Failure of implant'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",40.0,0.33731,"Longer implants showed a greater bone loss up to 5 years after loading than short implants both in maxillae (mean difference: -0.48 mm; 95% CI: -0.89 to -0.07 mm; P = 0.024) and in mandibles (mean difference: -0.48 mm; 95% CI: -0.79 to -0.18 mm; P = 0.004).
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Esposito', 'Affiliation': ''}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Barausse', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pistilli', 'Affiliation': ''}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Piattelli', 'Affiliation': ''}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Di Simone', 'Affiliation': ''}, {'ForeName': 'Daniela Rita', 'Initials': 'DR', 'LastName': 'Ippolito', 'Affiliation': ''}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Felice', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
1848,32409002,A novel EML4-ALK BIRC6-ALK double fusion variant in lung adenocarcinoma confers sensitivity to alectinib.,,2020,,[],"['BIRC6-ALK', 'EML4-ALK']",[],[],"[{'cui': 'C0910612', 'cui_str': 'BIRC6 protein, human'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}]",[],,0.0427387,,"[{'ForeName': 'Jiang-Ming', 'Initials': 'JM', 'LastName': 'Zhong', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'Gui-Feng', 'Initials': 'GF', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'De-Yu', 'Initials': 'DY', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China. Electronic address: liuzhenhua6909@163.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.04.030']
1849,31299766,Comparison of the Efficacies of Dry Needling and Botox Methods in the Treatment of Myofascial Pain Syndrome Affecting the Temporomandibular Joint.,"BACKGROUND


To compare the efficacies of botulinum toxin-A injection and dry needling methods in the treatment of patients with myofascial pain syndrome (MPS) in the temporomandibular joint (TMJ).
METHODS


In this prospective study, 40 MPS patients (29 women, 11 men) were randomly assigned to abobotulinum toxin-A injection (Group 1, n = 20) or dry needling (Group 2, n = 20) groups. Pain, crepitation, functional limitation, maximum mouth opening, jaw strength were evaluated at baseline and 6 weeks, and the results in both groups were compared.
RESULTS


The average age of the authors' patients was 33.8±8.1. There was a remarkable difference between 2 groups regarding visual analog scale for TMJ pain at rest (P = 0.048). The pain at rest was relieved more effectively in Group 2 at the end of 6 weeks. Improvement in jaw protrusion angles on the right (P = 0.009) and left (P = 0.002) sides was more evident in Group 2 after 6 weeks. There were significant pain relief and functional improvement after treatment in both groups. In Group 2, recovery of the TMJ function was more obvious in 6 weeks following dry needling (P = 0.002).
CONCLUSION


The authors suggest that abobotulinum toxin-A injection and dry needling yield satisfactory therapeutic outcomes regarding pain relief and restoration of function in patients with MPS involving TMJ. Further multicentric, randomized, controlled trials on larger series are warranted to obtain more accurate and reliable information.",2019,Improvement in jaw protrusion angles on the right (P = 0.009) and left (P = 0.002) sides was more evident in Group 2 after 6 weeks.,"['40 MPS patients (29 women, 11 men', 'patients with MPS involving TMJ', 'Myofascial Pain Syndrome Affecting the Temporomandibular Joint', 'patients with myofascial pain syndrome (MPS) in the temporomandibular joint (TMJ']","['Dry Needling and Botox Methods', 'abobotulinum toxin-A injection (Group 1, n\u200a=\u200a20) or dry needling', 'abobotulinum toxin-A injection and dry needling', 'botulinum toxin-A injection and dry needling methods']","['pain at rest', 'visual analog scale for TMJ pain', 'pain relief and functional improvement', 'recovery of the TMJ function', 'pain relief and restoration of function', 'Pain, crepitation, functional limitation, maximum mouth opening, jaw strength']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}, {'cui': 'C0027073', 'cui_str': 'Myofascial Pain Syndromes'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0700702', 'cui_str': 'Botox'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}]","[{'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0034642', 'cui_str': 'Rales'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}]",40.0,0.144863,Improvement in jaw protrusion angles on the right (P = 0.009) and left (P = 0.002) sides was more evident in Group 2 after 6 weeks.,"[{'ForeName': 'Sinem Gökçe', 'Initials': 'SG', 'LastName': 'Kütük', 'Affiliation': 'Department of Otorhinolaryngology, Aydin State Hospital.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Özkan', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Adnan Menderes University.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Kütük', 'Affiliation': 'Department of Anesthesia and Reanimation, Aydin State Hospital.'}, {'ForeName': 'Talih', 'Initials': 'T', 'LastName': 'Özdaş', 'Affiliation': 'Department of Otorhinolaryngology, University of Health Sciences, Adana City Hospital, Aydin, Turkey.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000005473']
1850,30451604,Protocol for Psychosocial Interventions Based on Integrative Body-Mind-Spirit (IBMS) Model for Children with Eczema and Their Parent Caregivers.,"PURPOSE


Eczema is a pediatric skin disease that affects the psychosocial well-being of both children and their parent caregivers. This paper outlines a protocol for an experimental study that evaluates the effectiveness of a psychosocial empowerment program for children with eczema and their parent caregivers.
METHOD


A multi-center randomized controlled trial is proposed, where parent-child dyads are randomized into two arms: an intervention group and wait-list control group. The intervention is delivered to participants in a parallel group format based on the Integrative Body-Mind-Spirit model which focuses on holistic well-being. Quality of life is measured before and after the intervention is provided, and five weeks after the intervention has been completed.
DISCUSSION


The suggested model fills a research gap in existing interventions, and provides new knowledge by evaluating the effectiveness of a tailored psychosocial intervention, delivered in group settings, for parent-child dyads affected by eczema.",2018,"This paper outlines a protocol for an experimental study that evaluates the effectiveness of a psychosocial empowerment program for children with eczema and their parent caregivers.
","['Children with Eczema and Their Parent Caregivers', 'parent-child dyads', 'children with eczema and their parent caregivers']","['psychosocial empowerment program', 'Integrative Body-Mind-Spirit (IBMS) Model', 'intervention group and wait-list control group']",['Quality of life'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1705899', 'cui_str': 'Spirit (basic dose form)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[{'cui': 'C0034380'}],,0.0332743,"This paper outlines a protocol for an experimental study that evaluates the effectiveness of a psychosocial empowerment program for children with eczema and their parent caregivers.
","[{'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Fung', 'Affiliation': 'a Department of Social Work and Social Administration , University of Hong Kong , Hong Kong , Hong Kong.'}, {'ForeName': 'Bobo Hi Po', 'Initials': 'BHP', 'LastName': 'Lau', 'Affiliation': 'a Department of Social Work and Social Administration , University of Hong Kong , Hong Kong , Hong Kong.'}, {'ForeName': 'Michelle Yi Jun', 'Initials': 'MYJ', 'LastName': 'Tam', 'Affiliation': 'a Department of Social Work and Social Administration , University of Hong Kong , Hong Kong , Hong Kong.'}, {'ForeName': 'Qianwen', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'a Department of Social Work and Social Administration , University of Hong Kong , Hong Kong , Hong Kong.'}, {'ForeName': 'Cecilia L W', 'Initials': 'CLW', 'LastName': 'Chan', 'Affiliation': 'a Department of Social Work and Social Administration , University of Hong Kong , Hong Kong , Hong Kong.'}, {'ForeName': 'Celia H Y', 'Initials': 'CHY', 'LastName': 'Chan', 'Affiliation': 'a Department of Social Work and Social Administration , University of Hong Kong , Hong Kong , Hong Kong.'}]",Journal of evidence-based social work (2019),['10.1080/23761407.2018.1545618']
1851,30461319,"A Prospective, Randomized Trial Comparing Open and Endoscopic Carpal Tunnel Release Within the Same Patient.","Background:  Surgical management of carpal tunnel syndrome includes performing an endoscopic (ECTR) or open (OCTR) carpal tunnel release. Several studies have shown less postoperative pain and improvement in grip and pinch strength with the endoscopic technique. The goal of this study was to prospectively examine outcomes, patient satisfaction, and complications after both ECTR and OCTR in the opposite hands of the same patient.  Methods:  This was a prospective study in which patients with bilateral carpal tunnel syndrome underwent surgical release with both techniques, with initial operative approach randomized in the more symptomatic hand. Demographic data and functional outcomes were recorded, including the pain score, 2-point discrimination, Semmes-Weinstein monofilament testing, thenar strength testing, grip strength, carpal tunnel syndrome functional status score, carpal tunnel syndrome symptom severity score, and overall satisfaction.  Results:  Thirty patients completed the study; there were no significant differences in any measure at any of the postoperative time points. Symptom severity and functional status scores were not significantly different between groups at any evaluation. Subjectively, 24 of 30 patients did state they preferred the ECTR, mostly citing less pain as their primary reason, although pain scores were not significantly different. Differences in overall satisfaction were also not significant.  Conclusions:  Both techniques are well tolerated with no differences in outcomes. With the added cost and equipment associated with ECTR, and no added benefit, the usefulness of ECTR is questionable.",2020,Symptom severity and functional status scores were not significantly different between groups at any evaluation.,"['patients with bilateral carpal tunnel syndrome underwent surgical release with both techniques, with initial operative approach randomized in the more symptomatic hand']","['Endoscopic Carpal Tunnel Release', 'endoscopic (ECTR) or open (OCTR) carpal tunnel release']","['postoperative pain', 'grip and pinch strength', 'overall satisfaction', 'postoperative time points', 'Symptom severity and functional status scores', 'pain score, 2-point discrimination, Semmes-Weinstein monofilament testing, thenar strength testing, grip strength, carpal tunnel syndrome functional status score, carpal tunnel syndrome symptom severity score, and overall satisfaction', 'pain scores', 'Demographic data and functional outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3864035', 'cui_str': 'Bilateral carpal tunnel syndrome (disorder)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0458125', 'cui_str': 'Endoscopic carpal tunnel release (procedure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0196576', 'cui_str': 'Carpal tunnel decompression'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",30.0,0.0282083,Symptom severity and functional status scores were not significantly different between groups at any evaluation.,"[{'ForeName': 'Brett M', 'Initials': 'BM', 'LastName': 'Michelotti', 'Affiliation': 'University of Wisconsin-Madison, USA.'}, {'ForeName': 'Kavita T', 'Initials': 'KT', 'LastName': 'Vakharia', 'Affiliation': 'Pennsylvania State University College of Medicine, Hershey, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Romanowsky', 'Affiliation': 'Pennsylvania State University College of Medicine, Hershey, USA.'}, {'ForeName': 'Randy M', 'Initials': 'RM', 'LastName': 'Hauck', 'Affiliation': 'Pennsylvania State University College of Medicine, Hershey, USA.'}]","Hand (New York, N.Y.)",['10.1177/1558944718812129']
1852,30477950,Predictive factors of pathological lateral pelvic lymph node metastasis in patients without clinical lateral pelvic lymph node metastasis (clinical stage II/III): The analysis of data from the clinical trial (JCOG0212).,"BACKGROUND


Mesorectal excision (ME) is the standard surgical procedure for lower rectal cancer. However, in Japan, total or tumor-specific ME with lateral pelvic lymph node dissection (LLND) is the standard surgical procedure for patients with clinical stages II or III lower rectal cancer, because lateral pelvic lymph node metastasis occasionally occurs in these patients. The aim of study was to elucidate the predictive factors of pathological lateral pelvic lymph node metastasis in patients without clinical lateral pelvic lymph node metastasis.
METHODS


Data form the clinical trial (JCOG0212) was analyzed. The JCOG0212 was a randomized controlled trial to confirm the non-inferiority of mesorectal excision alone to mesorectal excision with lateral lymph node dissection for clinical stage II/III patients who don't have clinical lateral pelvic lymph node metastasis in terms of relapse free survival. This study was conducted at a multitude of institution33 major hospitals in Japan. Among the 351 patients who underwent lateral lymph node dissection in the JCOG0212 study, 328 patients were included in this study. Associations between pathological lateral pelvic lymph node metastasis and preoperative and postoperative factors were investigated. The preoperative factors were age, sex, clinical stage, tumor location, distance from anal verge, tumor size, and short-axis diameter of lateral pelvic lymph node on computed tomography and the postoperative factors were pathological T, pathological N, and histological grade.
RESULTS


Among the 328 patients, 24 (7.3%) had pathological lateral pelvic lymph node metastasis. In multivariable analysis of the preoperative factors, patient age (p = 0.067), tumor location (p = 0.025), and short-axis diameter of lateral pelvic lymph node (p = 0.002) were significantly associated with pathological lateral pelvic lymph node metastasis.
CONCLUSIONS


Patient age, tumor location, and short-axis diameter of lateral pelvic lymph node were predictive factors of pathological lateral pelvic lymph node metastasis.",2019,"In multivariable analysis of the preoperative factors, patient age (p = 0.067), tumor location (p = 0.025), and short-axis diameter of lateral pelvic lymph node (p = 0.002) were significantly associated with pathological lateral pelvic lymph node metastasis.
","['patients without clinical lateral pelvic lymph node metastasis', '328 patients, 24 (7.3%) had pathological lateral pelvic lymph node metastasis', '351 patients who underwent lateral lymph node dissection in the JCOG0212 study, 328 patients were included in this study', 'patients without clinical lateral pelvic lymph node metastasis (clinical stage II/III', 'institution33 major hospitals in Japan']","['mesorectal excision alone to mesorectal excision with lateral lymph node dissection', 'Mesorectal excision (ME']",['short-axis diameter of lateral pelvic lymph node'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205571', 'cui_str': 'Clinical stage II (finding)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}]","[{'cui': 'C0522488', 'cui_str': 'Short axis (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}]",328.0,0.0450802,"In multivariable analysis of the preoperative factors, patient age (p = 0.067), tumor location (p = 0.025), and short-axis diameter of lateral pelvic lymph node (p = 0.002) were significantly associated with pathological lateral pelvic lymph node metastasis.
","[{'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Komori', 'Affiliation': 'Department of Surgery, Aichi Cancer Center Hospital, Nagoya, Japan. Electronic address: kkomori0701@ezweb.ne.jp.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Fujita', 'Affiliation': 'Department of Surgery, Tochigi Cancer Center, Tochigi, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'JCOG Data Center and Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'Colorectal Surgery Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Shiomi', 'Affiliation': 'Division of Colon and Rectal Surgery, Shizuoka Cancer Center Hospital, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohue', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Ota', 'Affiliation': 'Department of Surgery, Yokohama City University Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Akazai', 'Affiliation': 'Department of Surgery, Okayama Saiseikai General Hospital, Okayama, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Shiozawa', 'Affiliation': 'Department of Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Surgery, Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Bandou', 'Affiliation': 'Department of Surgery, Ishikawa Prefectural Central Hospital, Ishikawa, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Katsumata', 'Affiliation': 'Department of Surgery, Tokyo Medical University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kinugasa', 'Affiliation': 'Department of Colorectal Surgery, Tokyo Medical and Dental University, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Takii', 'Affiliation': 'Division of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Akasu', 'Affiliation': 'Department of Surgery, The Imperial Household Agency Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Moriya', 'Affiliation': 'Department of Surgery, Japanese Red Cross Medical Center, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2018.11.016']
1853,30470804,Effect of intermittent compared to continuous energy restriction on weight loss and weight maintenance after 12 months in healthy overweight or obese adults.,"BACKGROUND AND OBJECTIVE


Intermittent energy restriction (IER) is an alternative to continuous energy restriction (CER) for weight loss. There are few long-term trials comparing efficacy of these methods. The objective was to compare the effects of CER to two forms of IER; a week-on-week-off energy restriction and a 5:2 program, during which participants restricted their energy intake severely for 2 days and ate as usual for 5 days, on weight loss, body composition, blood lipids, and glucose.
SUBJECTS AND METHODS


A one-year randomized parallel trial was conducted at the University of South Australia, Adelaide, Australia. Participants were 332 overweight and obese adults, ages 18-72 years, who were randomized to 1 of 3 groups: CER (4200 kJ/day for women and 5040 kJ/day for men), week-on-week-off energy restriction (alternating between the same energy restriction as the continuous group for one week and one week of habitual diet), or 5:2 (2100 kJ/day on modified fast days each week for women and 2520 kJ/day for men, the 2 days of energy restriction could be consecutive or non-consecutive). Primary outcome was weight loss, and secondary outcomes were changes in body composition, blood lipids, and glucose.
RESULTS


For the 146 individuals who completed the study (124 female, 22 male, mean BMI 33 kg/m 2 ) mean weight loss, and body fat loss at 12 months was similar in the three intervention groups, -6.6 kg for CER, -5.1 kg for the week-on, week-off and -5.0 kg for 5:2 (p = 0.2 time by diet). Discontinuation rates were not different (p = 0.4). HDL-cholesterol rose (7%) and triglycerides decreased (13%) at 12 months with no differences between groups. No changes were seen for fasting glucose or LDL-cholesterol.
DISCUSSION AND CONCLUSION


The two forms of IER were not statistically different for weight loss, body composition, and cardiometabolic risk factors compared to CER.",2019,"The two forms of IER were not statistically different for weight loss, body composition, and cardiometabolic risk factors compared to CER.","['healthy overweight or obese adults', 'University of South Australia, Adelaide, Australia', 'Participants were 332 overweight and obese adults, ages 18-72 years', '146 individuals who completed the study (124 female, 22 male, mean BMI 33\u2009kg/m 2 ) mean weight loss, and body fat loss at 12 months was similar in the three intervention groups, -6.6\u2009kg for CER, -5.1\u2009kg for the week-on, week-off and -5.0\u2009kg for 5:2 (p\u2009=\u20090.2 time by diet']","['CER', 'continuous energy restriction']","['triglycerides', 'Discontinuation rates', 'weight loss, body composition, and cardiometabolic risk factors', 'HDL-cholesterol rose', 'fasting glucose or LDL-cholesterol', 'weight loss and weight maintenance', 'weight loss, and secondary outcomes were changes in body composition, blood lipids, and glucose', 'weight loss, body composition, blood lipids, and glucose']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C0237504', 'cui_str': 'CER (body structure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0237504', 'cui_str': 'CER (body structure)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",332.0,0.0324679,"The two forms of IER were not statistically different for weight loss, body composition, and cardiometabolic risk factors compared to CER.","[{'ForeName': 'Michelle Louise', 'Initials': 'ML', 'LastName': 'Headland', 'Affiliation': 'Division of Health Sciences, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Peter Marshall', 'Initials': 'PM', 'LastName': 'Clifton', 'Affiliation': 'Division of Health Sciences, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Jennifer Beatrice', 'Initials': 'JB', 'LastName': 'Keogh', 'Affiliation': 'Division of Health Sciences, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia. jennifer.keogh@unisa.edu.au.'}]",International journal of obesity (2005),['10.1038/s41366-018-0247-2']
1854,30372680,A Randomized Controlled Trial of Adherence to a 24-Month Home-Based Physical Activity Program and the Health Benefits for Older Adults at Risk of Alzheimer's Disease: The AIBL Active-Study.,"BACKGROUND


Previous studies have demonstrated that physical activity (PA) interventions can improve physical and cognitive outcomes in older adults, but most have been relatively short in duration (<1 year) with a few having specifically targeting individuals at risk of developing Alzheimer's disease.
OBJECTIVE


To examine adherence and physical health outcomes in a 24-month home-based PA intervention in older adults at risk of Alzheimer's disease.
METHODS


Participants 60 years and older with mild cognitive impairment (MCI) or subjective memory complaints (SMC) with at least 1 cerebrovascular risk factor recruited from The Australian Imaging Biomarkers and Lifestyle Flagship Study of Aging (AIBL) were randomized to a PA or control group (n = 106). The control group continued with their usual lifestyle. The PA group received a 24-month home-based program with a target of 150 minutes/week of moderate PA and a behavioral intervention. Retention (participants remaining) and PA adherence (PA group only, percent PA completed to the PA prescribed) were determined at 6, 12, 18, and 24 months. Assessments at baseline, 6, 12, and 24 months included, PA; fitness; body composition and fat distribution. Key outcome measures were PA adherence and PA.
RESULTS


The 24-month retention rate (97.2%) and the median PA adherence 91.67% (Q1-Q3, 81.96, 100.00) were excellent. In the long-term the intervention group achieved significantly better improvements in PA levels, leg strength, fat mass and fat distribution compared to the control.
CONCLUSION


This study demonstrates that in this target group, long-term PA adherence is achievable and has physical health benefits.",2019,"In the long-term the intervention group achieved significantly better improvements in PA levels, leg strength, fat mass and fat distribution compared to the control.
","[""older adults at risk of Alzheimer's disease"", 'Participants 60 years and older with mild cognitive impairment (MCI) or subjective memory complaints (SMC) with at least 1 cerebrovascular risk factor recruited from The Australian Imaging Biomarkers and Lifestyle Flagship Study of Aging (AIBL', ""Older Adults at Risk of Alzheimer's Disease"", 'older adults']","['physical activity (PA) interventions', '24-month home-based program with a target of 150 minutes/week of moderate PA and a behavioral intervention', 'home-based PA intervention', '24-Month Home-Based Physical Activity Program']","['median PA adherence', 'PA levels, leg strength, fat mass and fat distribution', 'PA; fitness; body composition and fat distribution', 'PA adherence and PA', '24-month retention rate']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.0389063,"In the long-term the intervention group achieved significantly better improvements in PA levels, leg strength, fat mass and fat distribution compared to the control.
","[{'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': 'Medical School University of Western Australia, Perth, Australia.'}, {'ForeName': 'Elizabeth V', 'Initials': 'EV', 'LastName': 'Cyarto', 'Affiliation': 'Bolton Clarke Research Institute, Melbourne, Australia.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Ellis', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ames', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Desmond', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Australia.'}, {'ForeName': 'Pramit', 'Initials': 'P', 'LastName': 'Phal', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Australia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Sharman', 'Affiliation': 'School of Health Sciences, University of Tasmania, Launceston, Tasmania, Australia.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Szoeke', 'Affiliation': 'Department of Medicine (Royal Melbourne Hospital), University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Rowe', 'Affiliation': 'Department of Molecular Imaging & Therapy, Austin Health, Melbourne, Australia.'}, {'ForeName': 'Colin L', 'Initials': 'CL', 'LastName': 'Masters', 'Affiliation': 'The Florey Institute, The University of Melbourne, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'You', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Burrows', 'Affiliation': 'Medical School University of Western Australia, Perth, Australia.'}, {'ForeName': 'Michelle M Y', 'Initials': 'MMY', 'LastName': 'Lai', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Lautenschlager', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-180521']
1855,31813076,"Effects of Depression, Stigma and Intimate Partner Violence on Postpartum Women's Adherence and Engagement in HIV Care in Kenya.","We explored the association between HIV-related stigma and experiences of intimate partner violence (IPV) and depression with viral load suppression, and medication and visit adherence in postpartum women receiving lifelong antiretroviral therapy (ART) (N = 200). We administered a cross-sectional survey to 200 women with HIV at 12 months postpartum who were enrolled in the MOTIVATE trial. The MOTIVATE study is a cluster-randomized trial evaluating the impact of community mentor mothers and text messaging on PMTCT outcomes in southwestern Kenya. Simple and multivariable logistic regression analysis was performed in STATA. Women who experienced stigma or IPV were more likely to miss clinic visits (internalized stigma aOR 1.30 95%CI 1.03-1.64; anticipated stigma aOR 1.20 95%CI 1.04-1.42; IPV aOR 15.71 95%CI 1.47-167.80), report difficulty taking ART drugs (internalized stigma aOR 1.32 95%CI 1.10-1.58; anticipated stigma aOR 1.14 95%CI 1.01-1.30) and not taking medication as prescribed (IPV aOR 2.00 95%CI 1.05-3.74). Depression was additionally associated with decreased odds of viral load suppression (aOR 0.16 95%CI 0.04-0.76). There is need to develop tailored psychosocial interventions within PMTCT programs that appropriately address mental health, stigma, and violence.",2020,Depression was additionally associated with decreased odds of viral load suppression (aOR 0.16 95%CI 0.04-0.76).,"['postpartum women receiving lifelong antiretroviral therapy (ART) (N\u2009=\u2009200', '200 women with HIV at 12\xa0months postpartum who were enrolled', 'community mentor mothers and text messaging on PMTCT outcomes in southwestern Kenya', ""Postpartum Women's Adherence and Engagement in HIV Care in Kenya""]",[],"['Depression', 'HIV-related stigma and experiences of intimate partner violence (IPV) and depression with viral load suppression, and medication and visit adherence', 'viral load suppression', 'Depression, Stigma and Intimate Partner Violence', 'stigma or IPV', 'miss clinic visits']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",200.0,0.173199,Depression was additionally associated with decreased odds of viral load suppression (aOR 0.16 95%CI 0.04-0.76).,"[{'ForeName': 'Maricianah', 'Initials': 'M', 'LastName': 'Onono', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, P.O. Box 19464-00202, Nairobi, Kenya. maricianah@gmail.com.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Odwar', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, P.O. Box 19464-00202, Nairobi, Kenya.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Abuogi', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver, Aurora, CO, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Owuor', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, P.O. Box 19464-00202, Nairobi, Kenya.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Helova', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bukusi', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, P.O. Box 19464-00202, Nairobi, Kenya.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Turan', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hampanda', 'Affiliation': 'Center for Global Health, Colorado School of Public Health, Aurora, CO, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02750-y']
1856,30352746,"A randomized, blinded, placebo-controlled trial comparing antibody responses to homeopathic and conventional vaccines in university students.","BACKGROUND


Homeopathic vaccines are licensed in many countries but scientific data to support their use are sparse. The goal of this study was to compare the antibody response of homeopathic and conventional vaccines and placebo in young adults. We hypothesized that there would be no significant difference between homeopathic vaccines and placebo, while there would be a significant increase in antibodies in those received conventional vaccines.
METHODS


A randomized blinded placebo-controlled trial was conducted where 150 university students who had received childhood vaccinations were assigned to diphtheria, pertussis, tetanus, mumps, measles homeopathic vaccine, placebo, or conventional diphtheria, pertussis, tetanus (Tdap) and mumps, measles, rubella (MMR) vaccines. The primary outcome was a ≥ two-fold increase in antibodies from baseline following vaccination as measured by ELISA. Participants, investigators, study coordinator, data blood drawers, laboratory technician, and data analyst were blinded.
RESULTS


None of the participants in either the homeopathic vaccine or the placebo group showed a ≥ two-fold response to any of the antigens. In contrast, of those vaccinated with Tdap, 68% (33/48) had a ≥ two-fold response to diphtheria, 83% (40/48) to pertussis toxoid, 88% (42/48) to tetanus, and 35% (17/48) of those vaccinated with MMR had a response to measles or mumps antigens (p < 0.001 for each comparison of conventional vaccine to homeopathic vaccine or to placebo). There was a significant increase in geometric mean titres of antibody from baseline for conventional vaccine antigens (p < 0.001 for each), but none for the response to homeopathic antigens or placebo.
CONCLUSIONS


Homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.
TRIAL REGISTRY


NCT 02825368.",2018,"There was a significant increase in geometric mean titres of antibody from baseline for conventional vaccine antigens (p < 0.001 for each), but none for the response to homeopathic antigens or placebo.
","['university students', 'young adults', '150 university students who had received childhood vaccinations']","['homeopathic and conventional vaccines and placebo', 'placebo', 'homeopathic vaccine', 'diphtheria, pertussis, tetanus, mumps, measles homeopathic vaccine, placebo, or conventional diphtheria, pertussis, tetanus (Tdap) and mumps, measles, rubella (MMR) vaccines', 'homeopathic and conventional vaccines']","['geometric mean titres of antibody', '≥\u202ftwo-fold increase in antibodies from baseline following vaccination as measured by ELISA', 'antibodies']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0026780', 'cui_str': 'Parotitis, Epidemic'}, {'cui': 'C0035923', 'cui_str': 'rubella, live attenuated'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}]",,0.496497,"There was a significant increase in geometric mean titres of antibody from baseline for conventional vaccine antigens (p < 0.001 for each), but none for the response to homeopathic antigens or placebo.
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Loeb', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, 1280 Main St West, MDCL 3208 Hamilton, Ontario L8S 4K1, Canada; Health Research Methodology, Evidence, and Impact, McMaster University, 1280 Main St West, MDCL 3208 Hamilton, Ontario L8S 4K1, Canada; Institute for Infectious Diseases Research, McMaster University, 1280 Main St West, MDCL 3208 Hamilton, Ontario L8S 4K1, Canada. Electronic address: loebm@mcmaster.ca.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Russell', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, 3280 Hospital Drive W Calgary, Alberta T2N4Z6, Canada.'}, {'ForeName': 'Binod', 'Initials': 'B', 'LastName': 'Neupane', 'Affiliation': 'Health Research Methodology, Evidence, and Impact, McMaster University, 1280 Main St West, MDCL 3208 Hamilton, Ontario L8S 4K1, Canada.'}, {'ForeName': 'Vitheya', 'Initials': 'V', 'LastName': 'Thanabalan', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, 1280 Main St West, MDCL 3208 Hamilton, Ontario L8S 4K1, Canada.'}, {'ForeName': 'Pardeep', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, 1280 Main St West, MDCL 3208 Hamilton, Ontario L8S 4K1, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Newton', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, 1280 Main St West, MDCL 3208 Hamilton, Ontario L8S 4K1, Canada.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Pullenayegum', 'Affiliation': 'Hospital for Sick Childrene, 555 University Avenue Toronto, Ontario M5G 1X8, Canada.'}]",Vaccine,['10.1016/j.vaccine.2018.08.082']
1857,30308546,Comparison Between an Oral Sulfate Solution and a 2 L of Polyethylene Glycol/Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy.,"BACKGROUND/AIMS


This study aimed to compare the efficacy and tolerability of an oral sulfate solution (OSS) versus 2 L of polyethylene glycol/ascorbic acid (2L-PEG/Asc) for bowel cleansing before colonoscopy.
METHODS


A prospective, single-center, single-blinded, noninferiority, randomized, controlled trial was performed. The primary outcome was the rate of successful bowel cleansing, evaluated using the Boston Bowel Preparation Scale (BBPS). Secondary outcomes were examination time, polyp, and adenoma detection rate (PDR and ADR), tolerability, and safety. Ease of use, palatability, intention to reuse, and satisfaction were evaluated using a questionnaire.
RESULTS


A total of 187 participants were randomized to receive either OSS (n=93) or 2L-PEG/Asc (n=94). Successful bowel cleansing was achieved in 86.0% (80/93) of the OSS group, which was noninferior to the 2L-PEG/Asc group (88.3%, 83/94), with a difference of -2.3% by ITT analysis [95% confidence interval (CI) -12.0 to +7.4]. The withdrawal time of the OSS group was significantly shorter than that of the 2L-PEG/Asc group (11.8±5.2 vs. 14.3±8.5; P=0.016). Ease of use, palatability, intention to reuse, and satisfaction were similar between the 2 groups. Adverse events were also similar between the 2 groups. Mucosal erythema (4.3%) and aphthous lesions (2.1%) were found only in the 2L-PEG/Asc group.
CONCLUSIONS


OSS was as effective as 2L-PEG/Asc for successful bowel cleansing and had acceptable tolerability. OSS is a promising and safe low-volume preparation alternative for colonoscopy. (Clinical trial registration number: NCT02761213.).",2019,"Successful bowel cleansing was achieved in 86.0% (80/93) of the OSS group, which was noninferior to the 2L-PEG/Asc group (88.3%, 83/94), with a difference of -2.3% by ITT analysis [95% confidence interval (CI) -12.0 to +7.4].",['187 participants'],"['OSS', 'Oral Sulfate Solution and a 2\u2009L of Polyethylene Glycol+Ascorbic Acid', 'oral sulfate solution (OSS) versus 2\u2009L of polyethylene glycol/ascorbic acid (2L-PEG/Asc']","['Adverse events', 'aphthous lesions', 'Ease of use, palatability, intention to reuse, and satisfaction', 'examination time, polyp, and adenoma detection rate (PDR and ADR), tolerability, and safety', 'efficacy and tolerability', 'Successful bowel cleansing', 'Mucosal erythema', 'withdrawal time', 'rate of successful bowel cleansing, evaluated using the Boston Bowel Preparation Scale (BBPS', 'acceptable tolerability']","[{'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}]","[{'cui': 'C0449206', 'cui_str': 'OSS (body structure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0137914', 'cui_str': 'Polythene'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}]",187.0,0.134921,"Successful bowel cleansing was achieved in 86.0% (80/93) of the OSS group, which was noninferior to the 2L-PEG/Asc group (88.3%, 83/94), with a difference of -2.3% by ITT analysis [95% confidence interval (CI) -12.0 to +7.4].","[{'ForeName': 'Han Hee', 'Initials': 'HH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, College of Medicine, The Catholic University of Korea.'}, {'ForeName': 'Chul-Hyun', 'Initials': 'CH', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, College of Medicine, The Catholic University of Korea.'}, {'ForeName': 'Jin Su', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, College of Medicine, The Catholic University of Korea.'}, {'ForeName': 'Yu Kyung', 'Initials': 'YK', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, College of Medicine, The Catholic University of Korea.'}, {'ForeName': 'Bo-In', 'Initials': 'BI', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, College of Medicine, The Catholic University of Korea.'}, {'ForeName': 'Young-Seok', 'Initials': 'YS', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, College of Medicine, The Catholic University of Korea.'}, {'ForeName': 'In Seok', 'Initials': 'IS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, College of Medicine, The Catholic University of Korea.'}, {'ForeName': 'Myung-Gyu', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, College of Medicine, The Catholic University of Korea.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001137']
1858,30326770,Intranasal oxytocin does not alter initial perceptions of facial trustworthiness in younger or older adults.,"BACKGROUND


Oxytocin is a neuropeptide involved in a range of social processes, and prior research has shown that intranasal oxytocin (iOT) may enhance trusting behaviors. However, it is unclear whether iOT influences perceptions of whether a face is trustworthy. In addition, no studies in this literature have investigated whether the participant's age may play a moderating role in the effects of iOT on trust.
AIMS


We aimed to examine for the first time whether iOT influences perceptions of facial trustworthiness and eye-gaze patterns and, if so, whether age moderates these iOT effects.
METHODS


One hundred and eighteen participants took part in a randomized, double-blind, placebo-controlled, within-groups study. Participants made judgments about the perceived trustworthiness of a series of faces while their eye movements were monitored.
RESULTS


Younger and older adults differed in their judgments of facial trustworthiness. However, most critically, iOT had no effect on these judgments for either age group. For the eye-tracking data, prior age effects in attending to the stimuli were replicated, with older adults gazing less at the eye region and more at the mouth region relative to younger adults. However, iOT had no effect on eye gaze.
CONCLUSIONS


These findings are discussed in relation to the growing body of literature that suggests that the effect of iOT on social processing is complex and may not be as robust as first thought.",2019,"However, most critically, iOT had no effect on these judgments for either age group.","['younger or older adults', 'One hundred and eighteen participants took part', 'Younger and older adults']","['Intranasal oxytocin', 'intranasal oxytocin (iOT', 'placebo', 'Oxytocin']","['initial perceptions of facial trustworthiness', 'eye gaze']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4505383', 'cui_str': 'Eye Gaze'}]",118.0,0.205073,"However, most critically, iOT had no effect on these judgments for either age group.","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Grainger', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Julie D', 'Initials': 'JD', 'LastName': 'Henry', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Henriette R', 'Initials': 'HR', 'LastName': 'Steinvik', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Vanman', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881118806303']
1859,30335648,Effects of Early Parent Training on Mother-Infant Feeding Interactions.,"OBJECTIVE


This study examined whether professional behavioral and nutritional training for first-time mothers can improve feeding interaction at age 12 months.
METHODS


Participants were 128 mother-infant dyads: 86 in the intervention group and 42 in the control group. The mean mothers' age was 30 years (±2.6). The intervention group received Mother-Infant Feeding Interaction (MI-FI) training: 4 weekly workshops for mothers when infants were aged 4 to 6 months old, followed by internet-based support by a dietitian and social worker until infants reached age 12 months. The control group received municipal well-baby clinic's standard mother-infant support. We assessed the mothers' tolerance to ambiguity and feeding-related reports. Blinded coders evaluated videotaped home mealtime interactions (age 12 months) using the Chatoor Feeding Scale (CFS).
RESULTS


Significant intergroup differences emerged in mealtime interactions for 4 of the 5 CFS dimensions: dyadic conflict (MI-FI = 4.69 vs control = 8.38), talk and distraction (3.75 vs 4.90), struggle for control (2.30 vs 4.88), and maternal noncontingency (1.61 vs 2.75). Findings indicated significantly more positive mother-infant mealtime interactions and maternal responses to infant cues in the MI-FI group than in the control group.
CONCLUSION


Very early maternal training may support the development of more positive mother-infant feeding interactions. This may contribute to preserved internal hunger and satiety cues and improved eating habits.",2019,"Findings indicated significantly more positive mother-infant mealtime interactions and maternal responses to infant cues in the MI-FI group than in the control group.
","['Participants were 128 mother-infant dyads: 86 in the intervention group and 42 in the control group', 'for mothers when infants were aged 4 to 6 months old, followed by internet-based support by a dietitian and social worker until infants reached age 12 months', ""mean mothers' age was 30 years (±2.6"", 'Mother-Infant Feeding Interactions']","['Mother-Infant Feeding Interaction (MI-FI) training: 4 weekly workshops', 'Early Parent Training', 'professional behavioral and nutritional training', ""municipal well-baby clinic's standard mother-infant support""]","['talk and distraction', 'maternal noncontingency', 'mealtime interactions', 'Chatoor Feeding Scale (CFS', 'positive mother-infant mealtime interactions and maternal responses to infant cues']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C4039610', 'cui_str': 'Public well'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0587119', 'cui_str': 'Meal Times'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",128.0,0.0189314,"Findings indicated significantly more positive mother-infant mealtime interactions and maternal responses to infant cues in the MI-FI group than in the control group.
","[{'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Globus', 'Affiliation': 'Public Health, Department of Nutrition, Health and Behavior, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Latzer', 'Affiliation': 'Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Oded', 'Initials': 'O', 'LastName': 'Pshetatzki', 'Affiliation': 'Public Health, Department of Nutrition, Health and Behavior, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Carmit', 'Initials': 'C', 'LastName': 'Shani Levi', 'Affiliation': 'Department of Clinical Nutrition, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Shaoul', 'Affiliation': ""Pediatric Gastroenterology Unit, Ruth Rappaport Children's Hospital Rambam Health Care Campus, Haifa, Israel.""}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Elad', 'Affiliation': ""Pediatric Gastroenterology Unit, Ruth Rappaport Children's Hospital Rambam Health Care Campus, Haifa, Israel.""}, {'ForeName': 'Geila S', 'Initials': 'GS', 'LastName': 'Rozen', 'Affiliation': ""Pediatric Gastroenterology Unit, Ruth Rappaport Children's Hospital Rambam Health Care Campus, Haifa, Israel.""}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000625']
1860,30321084,Neuromuscular electrical stimulation combined with exercise decreases duration of mechanical ventilation in ICU patients: A randomized controlled trial.,"BACKGROUND


Early mobilization can be employed to minimize the duration of intensive care. However, a protocol combining neuromuscular electrical stimulation (NMES) with early mobilization has not yet been tested in ICU patients. Our aim was to assess the efficacy of NMES, exercise (EX), and combined therapy (NMES + EX) on duration of mechanical ventilation (MV) in critically ill patients.
METHODS


The participants in this randomized double-blind trial were prospectively recruited within 24 hours following admission to the intensive care unit of a tertiary hospital. Eligible patients had 18 years of age or older; MV for less than 72 hours; and no known neuromuscular disease. Computer-generated permuted block randomization was used to assign patients to NMES, EX, NMES + EX, or standard care (control group). The main endpoint was duration of MV. Clinical characteristics were also evaluated and intention to treat analysis was employed.
RESULTS


One hundred forty-four patients were assessed for eligibility to participate in the trial, 51 of whom were enrolled and randomly allocated into four groups: 11 patients in the NMES group, 13 in the EX group, 12 in the NMES + EX group, and 15 in the control group (CG). Duration of MV (days) was significantly shorter in the combined therapy (5.7 ± 1.1) and NMEN (9.0 ± 7.0) groups in comparison to CG (14.8 ± 5.4).
CONCLUSIONS


NMES + EX consisting of NMES and active EXs was well tolerated and resulted in shorter duration of MV in comparison to standard care or isolated therapy (NMES or EX alone).",2020,"Duration of MV (days) was significantly shorter in the combined therapy (5.7 ± 1.1) and NMEN (9.0 ± 7.0) groups in comparison to CG (14.8 ± 5.4).
","['Eligible patients had 18\xa0years of age or older', 'One hundred forty-four patients were assessed for eligibility to participate in the trial, 51 of whom were enrolled and randomly allocated into four groups: 11 patients in the NMES group, 13 in the EX group, 12 in the', 'critically ill patients', 'ICU patients']","['protocol combining neuromuscular electrical stimulation (NMES', 'Neuromuscular electrical stimulation combined with exercise', 'NMES\xa0+\xa0EX', 'NMES, exercise (EX), and combined therapy (NMES\xa0+\xa0EX', 'NMES, EX, NMES\xa0+\xa0EX, or standard care (control group']","['Duration of MV (days', 'duration of mechanical ventilation (MV', 'mechanical ventilation', 'shorter duration of MV', 'duration of MV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033972', 'cui_str': 'Psychotherapy, Multiple'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}]",144.0,0.212725,"Duration of MV (days) was significantly shorter in the combined therapy (5.7 ± 1.1) and NMEN (9.0 ± 7.0) groups in comparison to CG (14.8 ± 5.4).
","[{'ForeName': 'Francisco Valdez', 'Initials': 'FV', 'LastName': 'Dos Santos', 'Affiliation': 'Physical Therapy Department, University of Brasilia , Brasilia, Brazil.'}, {'ForeName': 'Gerson', 'Initials': 'G', 'LastName': 'Cipriano', 'Affiliation': 'Physical Therapy Department, University of Brasilia , Brasilia, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Vieira', 'Affiliation': 'Physical Therapy Department, University of Brasilia , Brasilia, Brazil.'}, {'ForeName': 'Adriana M', 'Initials': 'AM', 'LastName': 'Güntzel Chiappa', 'Affiliation': 'Intensive Care Unit, Hospital de Clinicas de Porto Alegre , Porto Alegre, Brazil.'}, {'ForeName': 'Graziella B F', 'Initials': 'GBF', 'LastName': 'Cipriano', 'Affiliation': 'Physical Therapy Department, University of Brasilia , Brasilia, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Vieira', 'Affiliation': 'Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Julio G', 'Initials': 'JG', 'LastName': 'Zago', 'Affiliation': 'Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Mariah', 'Initials': 'M', 'LastName': 'Castilhos', 'Affiliation': 'Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Marianne L', 'Initials': 'ML', 'LastName': 'da Silva', 'Affiliation': 'Physical Therapy Department, University of Brasilia , Brasilia, Brazil.'}, {'ForeName': 'Gaspar R', 'Initials': 'GR', 'LastName': 'Chiappa', 'Affiliation': 'Physical Therapy Department, University of Brasilia , Brasilia, Brazil.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1490363']
1861,30295731,Mifepristone treatment prior to insertion of a levonorgestrel releasing intrauterine system for improved bleeding control - a randomized controlled trial.,"STUDY QUESTION


Does pre-treatment with a low dose of mifepristone improve irregular vaginal bleeding patterns during the initial 3 months after LNG-IUS placement?
SUMMARY ANSWER


Mifepristone treatment prior to LNG-IUS insertion results in significantly lower bleeding and spotting rates but no significant reduction post insertion.
WHAT IS KNOWN ALREADY


One of the leading causes of premature discontinuation of the LNG-IUS is unscheduled bleeding in the first months following its insertion. Up to now, there has been no effective treatment to prevent this side effect which reduces continuation rates for one of the most effective contraceptives.
STUDY DESIGN, SIZE, DURATION


This randomized, double blinded, controlled trial was conducted between 2009 and 2015. In total, 68 women opting for a LNG-IUS were screened for eligibility, of whom 58 were randomized at a ratio of 1:1 in blocks of 10 to pre-treatment with mifepristone or a comparator. The main outcome was the rate of bleeding and spotting days reported during the first 3 months post LNG-IUS 52 mg placement.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Healthy women with regular and normal menstrual cycles aged 18-43 years were enrolled at a single center in a university hospital; 29 were allocated to 2 months pre-treatment with a low dose mifepristone and 29 to the comparator prior to insertion of the LNG-IUS. Women were advised to use barrier methods during the pre-treatment period. Bleeding diaries were collected for the pre-treatment period and for the first 6 months after the LNG-IUS placement.
MAIN RESULTS AND THE ROLE OF CHANCE


There were no differences in demographics or baseline characteristics between the study groups. Data for analysis of the main outcome were contributed by a per protocol population of 19 women per group. There was a significant lower bleeding and spotting rate in the mifepristone group (-17.8% points, P < 0.001) after 2 months of pretreatment but after the LNG-IUS insertion no significant difference could be seen. While no pregnancies occurred prior to LNG-IUS insertion in the mifepristone group, there were three unintended pregnancies in the comparator group which emphasizes the need for a reliable contraceptive potential in any pre-treatment regiment used in clinical practice.
LIMITATIONS, REASONS FOR CAUTION


The use of mifepristone prior to the LNG-IUS insertion in this trial was used as prophylaxis against unscheduled bleeding after the placement of the device. Although this side effect constitutes a major concern in a clinical setting, only a subset of women are at risk. This is the first study using pre-treatment to attempt improved bleeding control. The differences were small and the effect was short lasting but the reduced rate of bleeding and spotting observed during the first month following LNG-IUS insertion, even though not statistically significant, indicates that this approach may be further explored. The fact that there were three pregnancies in the comparator group stresses the need for any pre-treatment to also protect against unplanned pregnancy.
WIDER IMPLICATIONS OF THE FINDINGS


Modified treatment protocols of mifepristone could be used prior to the LNG-IUS insertion to investigate possible further improvement of the outcome. The effect size of the current dose used might have been more prominent in women with LNG-IUS if the treatment also continued some weeks after the placement of the device. Although the low dose of mifepristone used in this trial is not available in Europe, other progesterone receptor modulators currently available could be investigated in larger clinical trials. To avoid unintended pregnancy in the pretreatment period, the dosage used should, ideally, also be effective for contraception and the pretreatment period should be kept as short as possible.
STUDY FUNDING/COMPETING INTEREST(S)


This study was funded by the Swedish Research Council (2012-2844, 2017-00932), Stockholm County Council and Karolinska Institutet (ALF). Conflicts of interests for K.G.D. and H.K.K. are listed at the end of the paper. The other authors have no conflicts of interest.
TRIAL REGISTRATION NUMBER


EudraCT number 2009-009014-40. Regional ethical review board at Karolinska Institutet permit 2009/144-31/4.
TRIAL REGISTRATION DATE


20 July 2009.
DATE OF FIRST PATIENT’S ENROLMENT


24 November 2009.",2018,"Up to now, there has been no effective treatment to prevent this side effect which reduces continuation rates for one of the most effective contraceptives.
","['Swedish Research Council (2012-2844, 2017-00932), Stockholm County Council and Karolinska Institutet (ALF', 'Healthy women with regular and normal menstrual cycles aged 18-43 years were enrolled at a single center in a university hospital; 29', '’S ENROLMENT\n\n\n24 November 2009', '68 women opting for a LNG-IUS were screened for eligibility, of whom 58', '2009 and 2015']","['Mifepristone', 'levonorgestrel releasing intrauterine system', 'mifepristone or a comparator', 'mifepristone']","['bleeding and spotting rates', 'bleeding control', 'irregular vaginal bleeding patterns', 'rate of bleeding and spotting', 'rate of bleeding and spotting days', 'bleeding and spotting rate', 'Bleeding diaries']","[{'cui': 'C0035168'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C1708694', 'cui_str': 'Levonorgestrel-releasing intrauterine system'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205271', 'cui_str': 'Irregular (qualifier value)'}, {'cui': 'C2979982', 'cui_str': 'Vaginal Bleeding'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",68.0,0.249746,"Up to now, there has been no effective treatment to prevent this side effect which reduces continuation rates for one of the most effective contraceptives.
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Papaikonomou', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Kopp Kallner', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Söderdahl', 'Affiliation': 'Statisticon AB, Uppsala, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.""}]","Human reproduction (Oxford, England)",['10.1093/humrep/dey296']
1862,30295116,Effects of serotonin depletion and dopamine depletion on bimodal divided attention.,"Objectives:  This study aimed to explore the effects of acute phenylalanine tyrosine depletion (APTD) and acute tryptophan depletion (ATD) on bimodal divided attention. A balanced amino acid mixture (BAL) served as control condition. Methods:  Fifty-three healthy adults (final analyzed sample was  N  = 49, age:  M  = 23.8 years) were randomly assigned to APTD, ATD or BAL in a double-blind, between-subject approach. Divided attention was assessed after 4 h. Blood samples were taken before and 6 h after challenge intake. Results:  Amino acid concentrations following challenge intake significantly decreased (all  P  ≤ 0.01). There was a significant difference in the mean reaction time (RT) towards auditory stimuli, but not towards visual stimuli between the groups. Post-hoc comparison of mean RTs (auditory stimuli) showed a significant difference between ATD (RT = 604.0 ms, SD = 56.9 ms) and APTD (RT = 556.4 ms, SD = 54.2 ms;  P  = 0.037), but no RT difference between ATD and BAL or APTD and BAL (RT = 573.6 ms, SD = 45.7 ms). Conclusions:  The results indicate a possible dissociation between the effects of a diminished brain 5-HT and DA synthesis on the performance in a bimodal divided attention task. The difference was exclusively observed within the RT towards auditory signals.",2020,"There was a significant difference in the mean reaction time (RT) towards auditory stimuli, but not towards visual stimuli between the groups.",['54 healthy adults (age: M\u2009=\u200923.8 years'],"['serotonin depletion and dopamine depletion', 'acute phenylalanine-tyrosine depletion (APTD) and acute tryptophan depletion (ATD', 'APTD, ATD or BAL', 'balanced amino acid mixture (BAL']","['bimodal divided attention', 'visual stimuli', 'mean reaction time (RT) towards auditory stimuli']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0012383', 'cui_str': 'Dimercaprol'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}]","[{'cui': 'C0589101', 'cui_str': 'Divided attention, function (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus, function (observable entity)'}]",54.0,0.0337756,"There was a significant difference in the mean reaction time (RT) towards auditory stimuli, but not towards visual stimuli between the groups.","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Königschulte', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Civai', 'Affiliation': 'School of Psychology, University of Kent, Canterbury, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hildebrand', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Gaber', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': 'Cognitive Neuroscience, Institute of Neuroscience and Medicine (INM-3), Research Centre Jülich, Jülich, Germany.'}, {'ForeName': 'F D', 'Initials': 'FD', 'LastName': 'Zepf', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}]",The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry,['10.1080/15622975.2018.1532110']
1863,30341767,"Liraglutide, Sitagliptin, and Insulin Glargine Added to Metformin: The Effect on Body Weight and Intrahepatic Lipid in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease.","To investigate the effect of antidiabetic agents on nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM), 75 patients with T2DM and NAFLD under inadequate glycemic control by metformin were randomized (1:1:1) to receive add-on liraglutide, sitagliptin, or insulin glargine in this 26-week trial. The primary endpoint was the change in intrahepatic lipid (IHL) from baseline to week 26 as quantified by magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF). Secondary endpoints included changes in abdominal adiposity (subcutaneous adipose tissue [SAT] and visceral adipose tissue [VAT]), glycated hemoglobin, and body weight from baseline to week 26. We analysed data from intent-to-treat population. MRI-PDFF, VAT, and weight decreased significantly with liraglutide (15.4% ± 5.6% to 12.5% ± 6.4%, P < 0.001; 171.4 ± 27.8 to 150.5 ± 30.8, P = 0.003; 86.6 ± 12.9 kg to 82.9 ± 11.1 kg, P = 0.005, respectively) and sitagliptin (15.5% ± 5.6% to 11.7% ± 5.0%, P = 0.001; 153.4 ± 31.5 to 139.8 ± 27.3, P = 0.027; 88.2 ± 13.6 kg to 86.5 ± 13.2 kg, P = 0.005, respectively). No significant change in MRI-PDFF, VAT, or body weight was observed with insulin glargine. SAT decreased significantly in the liraglutide group (239.9 ± 69.0 to 211.3 ± 76.1; P = 0.020) but not in the sitagliptin and insulin glargine groups. Changes from baseline in MRI-PDFF, VAT, and body weight were significantly greater with liraglutide than insulin glargine but did not differ significantly between liraglutide and sitagliptin. Conclusion: Combined with metformin, both liraglutide and sitagliptin, but not insulin glargine, reduced body weight, IHL, and VAT in addition to improving glycemic control in patients with T2DM and NAFLD.",2019,"Changes from baseline in MRI-PDFF, VAT, and body weight were significantly greater with liraglutide than insulin glargine but did not differ significantly between liraglutide and sitagliptin.","['patients with T2DM and NAFLD', 'Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease', 'patients with type 2 diabetes mellitus (T2DM), 75 patients with T2DM and NAFLD under inadequate glycemic control by metformin']","['metformin, both liraglutide and sitagliptin, but not insulin glargine', 'antidiabetic agents', 'liraglutide, sitagliptin, or insulin glargine', 'Liraglutide, Sitagliptin, and Insulin Glargine Added to Metformin', 'insulin glargine', 'liraglutide']","['Body Weight and Intrahepatic Lipid', 'change in intrahepatic lipid (IHL', 'MRI-PDFF, VAT, or body weight', 'changes in abdominal adiposity (subcutaneous adipose tissue [SAT] and visceral adipose tissue [VAT]), glycated hemoglobin, and body weight', 'nonalcoholic fatty liver disease (NAFLD', 'MRI-PDFF, VAT, and weight', 'body weight, IHL, and VAT', 'MRI-PDFF, VAT, and body weight', 'SAT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",75.0,0.0226657,"Changes from baseline in MRI-PDFF, VAT, and body weight were significantly greater with liraglutide than insulin glargine but did not differ significantly between liraglutide and sitagliptin.","[{'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yao', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Kuang', 'Affiliation': 'The First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Xubin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Tianpei', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': 'Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Yushu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Jingtao', 'Initials': 'J', 'LastName': 'Dou', 'Affiliation': 'Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'CHINA-JAPAN Friendship Hospital, Beijing, China.'}, {'ForeName': 'Guijun', 'Initials': 'G', 'LastName': 'Qin', 'Affiliation': 'The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Henan Provincial Peoples Hospital, Zhengzhou, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Sihui', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Zhongyan', 'Initials': 'Z', 'LastName': 'Shan', 'Affiliation': 'The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hongrong', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Longyi', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Kang', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30320']
1864,30263977,"Ketamine, but Not the NMDAR Antagonist Lanicemine, Increases Prefrontal Global Connectivity in Depressed Patients.","Background


Identifying the neural correlates of ketamine treatment may facilitate and expedite the development of novel, robust, and safe rapid-acting antidepressants. Prefrontal cortex (PFC) global brain connectivity with global signal regression (GBCr) was recently identified as a putative biomarker of major depressive disorder (MDD). Accumulating evidence have repeatedly shown reduced PFC GBCr in MDD, an abnormality which appears to normalize following ketamine treatment.
Methods


Fifty-six unmedicated participants with MDD were randomized to intravenous placebo (normal saline; n = 18), ketamine (0.5mg/kg; n = 19) or lanicemine (100mg; n = 19). PFC GBCr was computed using time series from functional magnetic resonance imaging ( f MRI) scans that were completed at baseline, during infusion, and 24h post-treatment.
Results


Compared to placebo, ketamine significantly increased average PFC GBCr during infusion ( p  = 0.01) and 24h post-treatment ( p  = 0.02). Lanicemine had no significant effects on GBCr during infusion ( p  = 0.45) and 24h post-treatment ( p  = 0.23), compared to placebo. Average delta PFC GBCr (during minus baseline) showed a pattern of positively predicting depression improvement in participants receiving ketamine ( r  = 0.44;  p  = 0.06;  d  = 1.0) or lanicemine ( r  = 0.55;  p  = 0.01;  d  = 1.3), but not those receiving placebo ( r  = -0.1;  p  = 0.69;  d  = 0.02). Follow-up vertex-wise analyses showed ketamine-induced GBCr increases in the dorsolateral, dorsomedial, and frontomedial PFC during infusion, and in the dorsolateral and dorsomedial PFC 24h post-treatment ( corrected p  < 0.05). Exploratory vertex-wise analyses examining the relationship with depression improvement showed positive correlation with GBCr in the dorsal PFC during infusion and 24h post-treatment, but negative correlation with GBCr in the ventral PFC during infusion ( uncorrected p  < 0.01).
Conclusions


In a randomized placebo-controlled approach, the results provide the first evidence in MDD of ketamine-induced increases in PFC GBCr during infusion, and suggests that ketamine's rapid-acting antidepressant properties are related to its acute effects on prefrontal connectivity. Overall, the study findings underscore the similarity and differences between ketamine and another N-methyl-D-aspartate receptor (NMDAR) antagonist, while proposing a pharmacoimaging paradigm for optimization of novel rapid-acting antidepressants prior to testing in costly clinical trials.",2018,"Compared to placebo, ketamine significantly increased average PFC GBCr during infusion ( p  = 0.01) and 24h post-treatment ( p  = 0.02).","['Depressed Patients', 'Methods\n\n\nFifty-six unmedicated participants with MDD']","['ketamine', 'placebo', 'lanicemine ', 'ketamine and another N-methyl-D-aspartate receptor (NMDAR) antagonist', 'lanicemine', 'intravenous placebo', 'placebo, ketamine', 'Lanicemine', 'Ketamine', 'global signal regression (GBCr']","['average PFC GBCr', 'GBCr', 'Prefrontal Global Connectivity', 'depression improvement', 'Average delta PFC GBCr']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2697880'}, {'cui': 'C4521484', 'cui_str': 'N-methyl-D-aspartate receptor antagonist (disposition)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}]","[{'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",56.0,0.20495,"Compared to placebo, ketamine significantly increased average PFC GBCr during infusion ( p  = 0.01) and 24h post-treatment ( p  = 0.02).","[{'ForeName': 'Chadi G', 'Initials': 'CG', 'LastName': 'Abdallah', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, Connecticut.'}, {'ForeName': 'Arpan', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': 'University of Manchester, Manchester, UK.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Averill', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, Connecticut.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'McKie', 'Affiliation': 'University of Manchester, Manchester, UK.'}, {'ForeName': 'Teddy J', 'Initials': 'TJ', 'LastName': 'Akiki', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, Connecticut.'}, {'ForeName': 'Lynnette A', 'Initials': 'LA', 'LastName': 'Averill', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, Connecticut.'}, {'ForeName': 'J F William', 'Initials': 'JFW', 'LastName': 'Deakin', 'Affiliation': 'University of Manchester, Manchester, UK.'}]","Chronic stress (Thousand Oaks, Calif.)",['10.1177/2470547018796102']
1865,31654345,Laparoscopic One-Anastomosis Gastric Bypass with Band-Separated Gastric Pouch (OAGB-BSGP): a Randomized Controlled Trial.,"BACKGROUND


One-anastomosis gastric bypass with band-separated gastric pouch (OAGB-BSGP) is a novel ""staplerless"" version of OAGB. This randomized controlled trial (RCT) compared 2-year outcomes for OAGB-BSGP and standard OAGB.
METHODS


The parallel-group RCT randomly allocated patients to group A, staplerless OAGB-BSGP, or group B, stapled OAGB.
RESULTS


Respective mean values for groups A and B (n = 40 each): baseline body mass index (BMI, kg/m 2 ), 40.6 ± 5.6 vs 41.2 ± 6.4 (p = 0.64); abdominal bleeding (mL), 5.9 ± 8.0 vs 31.1 ± 30.5 (p < 0.0001). Two-year outcomes: BMI, 26.3 ± 3.2 vs 29.0 ± 4.7; %TWL, 34.1 ± 9.0 vs 29.3 ± 10.6, p < 0.03; %EBMIL, 94.3 ± 23.6 vs 77.9 ± 29.3, p < 0.007; bile reflux, n = 1 (2.5%) vs n = 7 (17.5%) (p = 0.05); revisions, n = 0 vs n = 4 (10.0%), p = 0.12.
CONCLUSIONS


At 2-year RCT follow-up, staplerless OAGB-BSGP patients had fewer complications, no revisions, and greater weight loss than stapled OAGB patients.
TRIAL REGISTRATION


ISRCTN56106651 (OSPAN-RCT).",2019,"At 2-year RCT follow-up, staplerless OAGB-BSGP patients had fewer complications, no revisions, and greater weight loss than stapled OAGB patients.
",[],"['staplerless OAGB-BSGP, or group B, stapled OAGB', 'Laparoscopic One-Anastomosis Gastric Bypass with Band-Separated Gastric Pouch (OAGB-BSGP', 'anastomosis gastric bypass with band-separated gastric pouch (OAGB-BSGP', 'OAGB-BSGP and standard OAGB']","['weight loss', 'abdominal bleeding']",[],"[{'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C4319584', 'cui_str': 'Pouch (unit of presentation)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]",,0.255256,"At 2-year RCT follow-up, staplerless OAGB-BSGP patients had fewer complications, no revisions, and greater weight loss than stapled OAGB patients.
","[{'ForeName': 'Oral', 'Initials': 'O', 'LastName': 'Ospanov', 'Affiliation': 'University Medical Center, Nur-Sultan, Kazakhstan. bariatric.kz@gmail.com.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Buchwald', 'Affiliation': 'Division of Scientific Research Writing, Medwrite Medical Communications, Maiden Rock, WI, USA.'}, {'ForeName': 'Galymzhan', 'Initials': 'G', 'LastName': 'Yeleuov', 'Affiliation': 'University Medical Center, Nur-Sultan, Kazakhstan.'}, {'ForeName': 'Farida', 'Initials': 'F', 'LastName': 'Bekmurzinova', 'Affiliation': 'University Medical Center, Nur-Sultan, Kazakhstan.'}]",Obesity surgery,['10.1007/s11695-019-04236-1']
1866,30160635,Risk of Falls in Healthy Older Adults: Benefits of High-Intensity Interval Training Using Lower Body Suspension Exercises.,"The objective of this study was to compare the effects of high-intensity interval training (HIIT) and moderate-intensity interval training (MIIT) programs, both with a suspension training system, on several fall risk factors in healthy older adults. A total of 82 participants (68.23 ± 2.97 years) were randomized to HIIT ( n  = 28), MIIT ( n  = 27), or control ( n  = 27) groups. Balance confidence (Activities-specific Balance Confidence Scale), fear of falling (Falls Efficacy Scale-International), dynamic balance (Timed Up and Go test), and gait analysis (OptoGait optical detection system) were assessed. Statistical analysis showed improvements after the intervention in the HIIT group compared with the MIIT and control groups regarding the fear of falling ( p  < .05 and  p  < .01, respectively), gait (both  p s < .05), and dynamic balance ( p  < .05 and  p  < .01, respectively), whereas both HIIT and MIIT groups improved balance confidence compared with the control group ( p  < .01 and  p  < .05, respectively). We can conclude that HIIT has significant beneficial effects of fall risk in older adults.",2019,"Statistical analysis showed improvements after the intervention in the HIIT group compared with the MIIT and control groups regarding the fear of falling ( p  < .05 and  p  < .01, respectively), gait (","['Healthy Older Adults', 'A total of 82 participants (68.23\u2009±\u20092.97 years', 'healthy older adults', 'older adults']","['high-intensity interval training (HIIT) and moderate-intensity interval training (MIIT) programs, both with a suspension training system', 'High-Intensity Interval Training']","['gait ', 'Balance confidence (Activities-specific Balance Confidence Scale), fear of falling (Falls Efficacy Scale-International), dynamic balance (Timed Up and Go test), and gait analysis (OptoGait optical detection system', 'fear of falling', 'dynamic balance', 'balance confidence']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C2733457', 'cui_str': 'ABC (activities-specific balance confidence) scale'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0222045'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0558820', 'cui_str': 'Gait Analysis'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",82.0,0.0232209,"Statistical analysis showed improvements after the intervention in the HIIT group compared with the MIIT and control groups regarding the fear of falling ( p  < .05 and  p  < .01, respectively), gait (","[{'ForeName': 'José D', 'Initials': 'JD', 'LastName': 'Jiménez-García', 'Affiliation': ''}, {'ForeName': 'Fidel', 'Initials': 'F', 'LastName': 'Hita-Contreras', 'Affiliation': ''}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'de la Torre-Cruz', 'Affiliation': ''}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Fábrega-Cuadros', 'Affiliation': ''}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Aibar-Almazán', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cruz-Díaz', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Martínez-Amat', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0190']
1867,30264745,A randomized controlled trial of topical benzoyl peroxide 2.5% gel with a low glycemic load diet versus topical benzoyl peroxide 2.5% gel with a normal diet in acne (grades 1-3).,"Background


The improvement in insulin resistance and acne lesions on low glycemic load diets in various studies suggests that diet plays a significant role in acne pathogenesis.
Aims


To compare the efficacy of a low glycemic load diet plus topical benzoyl peroxide 2.5% gel with that of only topical benzoyl peroxide 2.5% gel in grades 1, 2 and 3 of acne vulgaris.
Methods


In a randomized controlled trial, 84 patients with grades 1, 2 and 3 acne vulgaris were divided into two groups, to receive a low glycemic load diet and no dietary intervention respectively. Acne lesions (face) were scored and graded at baseline and 4, 8 and 12 weeks. Homeostasis model assessment of insulin resistance and body mass index were measured during the first and last visits. Statistical analysis was done with Statistical Package for the Social Sciences, version 17.0.
Results


Both groups showed significant reduction in acne counts at 12 weeks (P = 0.931) with no statistically significant difference between the groups. The differences in body mass index and homeostasis model assessment of insulin resistance between the groups were statistically significant (P = 0.0001). Group 1 showed reductions in body mass index and homeostasis model assessment of insulin resistance values at the end of the study, whereas group 2 did not.
Limitations


Application of mild topical cleanser in both the groups might have contributed to the improvement in epidermal barrier function, and topical application of 2.5% of benzoyl peroxide gel in both groups contributed to the improvement in acne counts.
Conclusions


A low glycemic load diet did not result in any significant improvement in acne counts.",2019,Both groups showed significant reduction in acne counts at 12 weeks (P = 0.931) with no statistically significant difference between the groups.,"['84 patients with grades 1, 2 and 3 acne vulgaris', 'grades 1, 2 and 3 of acne vulgaris']","['low glycemic load diet plus topical benzoyl peroxide', 'low glycemic load diet and no dietary intervention respectively', 'topical benzoyl peroxide 2.5% gel with a low glycemic load diet versus topical benzoyl peroxide 2.5% gel with a normal diet']","['body mass index and homeostasis model assessment of insulin resistance', 'insulin resistance and acne lesions', 'acne counts', 'insulin resistance and body mass index', 'body mass index and homeostasis model assessment of insulin resistance values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4042927', 'cui_str': 'Glycemic Load'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",84.0,0.0265849,Both groups showed significant reduction in acne counts at 12 weeks (P = 0.931) with no statistically significant difference between the groups.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pavithra', 'Affiliation': 'Department of Dermatology, Kasturba Medical College Hospital, Manipal Academy of Higher Education, Mangalore, Karnataka, India.'}, {'ForeName': 'Gatha M', 'Initials': 'GM', 'LastName': 'Upadya', 'Affiliation': 'Department of Dermatology, Kasturba Medical College Hospital, Manipal Academy of Higher Education, Mangalore, Karnataka, India.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Rukmini', 'Affiliation': 'Department of Biochemistry, Kasturba Medical College Hospital, Manipal Academy of Higher Education, Mangalore, Karnataka, India.'}]","Indian journal of dermatology, venereology and leprology",['10.4103/ijdvl.IJDVL_109_17']
1868,31863016,Optimized Measurement Parameters of Sensory Evoked Cortical Potentials to Assess Human Bladder Afferents - A Randomized Study.,"Overactive bladder and voiding dysfunction are highly prevalent and often associated with malfunction of the bladder afferent pathways. Appropriate diagnostic tools for an objective assessment of afferent nerve function of the human bladder are currently missing. One promising possibility is the assessment of sensory evoked potentials (SEP) during repetitive electrical bladder stimulation, which proved feasible in healthy subjects. For an implementation into clinical practice, however, further refinements for efficient and reliable data acquisition are crucial. The aim of this randomized study was to find the optimal measurement settings regarding stimulation frequency, repetition number, and data acquisition. Forty healthy subjects underwent two visits of SEP (Cz-Fz) assessments using repetitive (500 stimuli) electrical stimulation of 0.5 Hz, 1.1 Hz, and 1.6 Hz and pulse width of 1 ms at the bladder dome or trigone. SEP analyses revealed higher amplitudes and better signal-to-noise ratio (SNR) with lower stimulation frequencies, while latencies remained unchanged. Decreasing amplitudes and SNR were observed with continuing stimulation accompanied by decreasing responder rate (RR). When applying stimuli at a frequency of 0.5 Hz, averaging across 200 stimuli revealed optimal reliability with best SNR, RR and sufficiently high amplitudes. This constitutes an optimal compromise between the duration of the assessment and SEP peak-to-peak amplitudes.",2019,"SEP analyses revealed higher amplitudes and better signal-to-noise ratio (SNR) with lower stimulation frequencies, while latencies remained unchanged.","['Forty healthy subjects', 'healthy subjects']","['SEP (Cz-Fz) assessments using repetitive (500 stimuli) electrical stimulation of 0.5\u2009Hz, 1.1\u2009Hz, and 1.6\u2009Hz and pulse width of 1\u2009ms at the bladder dome or trigone']","['Overactive bladder and voiding dysfunction', 'responder rate (RR', 'higher amplitudes and better signal-to-noise ratio (SNR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0444914', 'cui_str': 'Domed (qualifier value)'}]","[{'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0429826', 'cui_str': 'Dysfunctional voiding of urine (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}]",500.0,0.0730988,"SEP analyses revealed higher amplitudes and better signal-to-noise ratio (SNR) with lower stimulation frequencies, while latencies remained unchanged.","[{'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'van der Lely', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Martina D', 'Initials': 'MD', 'LastName': 'Liechti', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Schmidhalter', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schubert', 'Affiliation': 'Neurophysiology, Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Bachmann', 'Affiliation': 'Medignition Inc., Research Consultants, Zürich, Switzerland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kessler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mehnert', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland. ulrich.mehnert@balgrist.ch.'}]",Scientific reports,['10.1038/s41598-019-54614-z']
1869,30160577,Effects of Melatonin Ingestion Before Nocturnal Sleep on Postural Balance and Subjective Sleep Quality in Older Adults.,"The present study aimed to investigate the effect of acute nocturnal melatonin (MEL) ingestion on sleep quality, cognitive performance, and postural balance in older adults. A total of 12 older men (58 ± 5.74 years) volunteered to participate in this study. The experimental protocol consisted in two testing sessions after nocturnal MEL (10 mg) or placebo ingestion the night before the tests. During each session, sleep quality tests, cognitive tests, and postural balance protocol were conducted. Static and dynamic postural control was assessed using a force platform. Most of the sleep parameters have been improved following nocturnal MEL ingestion without any effect on cognitive performance. Likewise, measurements related to the center of pressure (CoP) have been significantly decreased with MEL compared with placebo. In conclusion, postural control has been improved the morning following nocturnal MEL ingestion in older adults. This trend could be explained by the potential effect of MEL on sleep quality and cerebellum.",2019,Most of the sleep parameters have been improved following nocturnal MEL ingestion without any effect on cognitive performance.,"['12 older men (58\u2009±\u20095.74\xa0years) volunteered to participate in this study', 'Older Adults', 'older adults']","['placebo ingestion', 'placebo', 'MEL', 'Melatonin Ingestion', 'acute nocturnal melatonin (MEL) ingestion']","['center of pressure (CoP', 'sleep quality tests, cognitive tests, and postural balance protocol', 'sleep quality, cognitive performance, and postural balance', 'Static and dynamic postural control', 'Postural Balance and Subjective Sleep Quality', 'cognitive performance']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",12.0,0.0386482,Most of the sleep parameters have been improved following nocturnal MEL ingestion without any effect on cognitive performance.,"[{'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Kamoun', 'Affiliation': ''}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': ''}, {'ForeName': 'Abdelmoneem', 'Initials': 'A', 'LastName': 'Yahia', 'Affiliation': ''}, {'ForeName': 'Oussema', 'Initials': 'O', 'LastName': 'Dhari', 'Affiliation': ''}, {'ForeName': 'Houcem', 'Initials': 'H', 'LastName': 'Ksentini', 'Affiliation': ''}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': ''}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Souissi', 'Affiliation': ''}, {'ForeName': 'Mohamed Habib', 'Initials': 'MH', 'LastName': 'Elleuch', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0107']
1870,30265610,"Epacadostat Plus Pembrolizumab in Patients With Advanced Solid Tumors: Phase I Results From a Multicenter, Open-Label Phase I/II Trial (ECHO-202/KEYNOTE-037).","PURPOSE


Tumors may evade immunosurveillance through upregulation of the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme. Epacadostat is a potent and highly selective IDO1 enzyme inhibitor. The open-label phase I/II ECHO-202/KEYNOTE-037 trial evaluated epacadostat plus pembrolizumab, a programmed death protein 1 inhibitor, in patients with advanced solid tumors. Phase I results on maximum tolerated dose, safety, tolerability, preliminary antitumor activity, and pharmacokinetics are reported.
PATIENTS AND METHODS


Patients received escalating doses of oral epacadostat (25, 50, 100, or 300 mg) twice per day plus intravenous pembrolizumab 2 mg/kg or 200 mg every 3 weeks. During the safety expansion, patients received epacadostat (50, 100, or 300 mg) twice per day plus pembrolizumab 200 mg every 3 weeks.
RESULTS


Sixty-two patients were enrolled and received one or more doses of study treatment. The maximum tolerated dose of epacadostat in combination with pembrolizumab was not reached. Fifty-two patients (84%) experienced treatment-related adverse events (TRAEs), with fatigue (36%), rash (36%), arthralgia (24%), pruritus (23%), and nausea (21%) occurring in ≥ 20%. Grade 3/4 TRAEs were reported in 24% of patients. Seven patients (11%) discontinued study treatment because of TRAEs. No TRAEs led to death. Epacadostat 100 mg twice per day plus pembrolizumab 200 mg every 3 weeks was recommended for phase II evaluation. Objective responses (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) occurred in 12 (55%) of 22 patients with melanoma and in patients with non-small-cell lung cancer, renal cell carcinoma, endometrial adenocarcinoma, urothelial carcinoma, and squamous cell carcinoma of the head and neck. The pharmacokinetics of epacadostat and pembrolizumab and antidrug antibody rate were comparable to historical controls for monotherapies.
CONCLUSION


Epacadostat in combination with pembrolizumab generally was well tolerated and had encouraging antitumor activity in multiple advanced solid tumors.",2018,"The pharmacokinetics of epacadostat and pembrolizumab and antidrug antibody rate were comparable to historical controls for monotherapies.
","['22 patients with melanoma and in patients with non-small-cell lung cancer, renal cell carcinoma, endometrial adenocarcinoma, urothelial carcinoma, and squamous cell carcinoma of the head and neck', 'patients with advanced solid tumors', 'Patients received', 'Solid Tumors', 'Patients With Advanced Solid Tumors', 'Sixty-two patients were enrolled and received one or more doses of study treatment']","['Open-Label', 'escalating doses of oral epacadostat', 'Epacadostat 100 mg twice per day plus pembrolizumab', 'Epacadostat Plus Pembrolizumab', 'pembrolizumab']","['pharmacokinetics of epacadostat and pembrolizumab and antidrug antibody rate', 'pruritus', 'arthralgia', 'Grade 3/4 TRAEs', 'antitumor activity', 'maximum tolerated dose, safety, tolerability, preliminary antitumor activity, and pharmacokinetics', 'treatment-related adverse events (TRAEs), with fatigue', 'nausea', 'rash']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C1153706', 'cui_str': 'Adenocarcinoma of uterus (disorder)'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4086265', 'cui_str': 'epacadostat'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4086265', 'cui_str': 'epacadostat'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439611', 'cui_str': 'Preliminary (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",62.0,0.0502529,"The pharmacokinetics of epacadostat and pembrolizumab and antidrug antibody rate were comparable to historical controls for monotherapies.
","[{'ForeName': 'Tara C', 'Initials': 'TC', 'LastName': 'Mitchell', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Smith', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Bauer', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Wasser', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Olszanski', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Luke', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Ani S', 'Initials': 'AS', 'LastName': 'Balmanoukian', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Emmett V', 'Initials': 'EV', 'LastName': 'Schmidt', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Yufan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Maleski', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Leopold', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Gajewski', 'Affiliation': 'Tara C. Mitchell, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Omid Hamid and Ani S. Balmanoukian, The Angeles Clinic and Research Institute, Los Angeles, CA; David C. Smith, University of Michigan, Ann Arbor, MI; Todd M. Bauer, Tennessee Oncology, Nashville, TN; Jeffrey S. Wasser, University of Connecticut School of Medicine, Farmington, CT; Jason J. Luke and Thomas F. Gajewski, University of Chicago Medicine, Chicago, IL; Emmett V. Schmidt, Merck & Co, Kenilworth, NJ; and Yufan Zhao, Xiaohua Gong, Janet Maleski, and Lance Leopold, Incyte Corporation, Wilmington, DE.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2018.78.9602']
1871,30160530,Prenatal Yoga: Effects on Alleviation of Labor Pain and Birth Outcomes.,"Background:  This study was conducted to test the hypothesis that prenatal yogic exercises are effective in alleviating labor pain and improving birth outcomes, by comparing pregnant women undertaking yoga with a control group.  Trial design:  Single blinded, parallel randomized control trial.  Methods:  Two hundred primigravid women of 30 weeks of gestation onward who met the inclusion criteria (primigravida, 20-35 years of age, gestational age of 30 weeks, no prior experience of yoga) were randomly assigned to study ( n  = 100) and control groups ( n  = 100) by using the minimized randomization program version 2.01. The study group received the intervention in the form of integrated yoga consisting of a series of 30-min practice sessions at the 30th, 32nd, 34th, 36th, 37th, 38th, and 39th weeks of gestational age. The matched control group did not perform yoga. The patients were followed till delivery for maternal comfort, alleviation of labor pain, and birth outcome. Alleviation of labor pain was assessed by using numerical pain intensity scale (NPIS), pain behavioral observational scale (PBOS), and maternal delivery comfort questionnaire. Only the assessors were blinded.  Results:  Two hundred patients were randomized into 100 each in case and control groups. Final analysis was done on 75 patients in each group after exclusion due to development of complications, loss to follow-up. The requirement of induction of labor and analgesics was significantly less in the study group ( p  < 0.044,  p  < 0.045). There was significantly more number of normal vaginal deliveries ( p  < 0.037) and less caesarean sections ( p  < 0.048), shorter first stage of labor ( p  < 0.0003) in the study group practicing yoga. The tolerance of pain was better in the study group as shown by NPIS ( p  < 0.001) and PBOS scores ( p  < 0.0001). Postpartum, the maternal comfort questionnaire score showed higher comfort in the study group ( p  < 0.032). The number of low birth weight babies was also significantly less in the study group ( p  < 0.042). There were no adverse effects attributed to yoga.  Conclusion:  The study has highlighted that yoga is a noninvasive, easy to learn mind-body medicine and complementary health practice, effective in alleviation of labor pain and possibly improving birth outcome.",2018,The tolerance of pain was better in the study group as shown by NPIS (p < 0.001) and PBOS scores (p < 0.0001).,"['pregnant women undertaking yoga with a control group', 'Two hundred patients', 'Two hundred primigravid women of 30 weeks of gestation onward who met the inclusion criteria (primigravida, 20-35 years of age, gestational age of 30 weeks, no prior experience of yoga']","['Prenatal Yoga', 'prenatal yogic exercises']","['Alleviation of Labor Pain and Birth Outcomes', 'number of normal vaginal deliveries', 'tolerance of pain', 'PBOS scores', 'Alleviation of labor pain', 'number of low birth weight babies', 'requirement of induction of labor and analgesics', 'shorter first stage of labor', 'caesarean sections', 'maternal comfort, alleviation of labor pain, and birth outcome', 'numerical pain intensity scale (NPIS), pain behavioral observational scale (PBOS), and maternal delivery comfort questionnaire', 'labor pain and improving birth outcomes', 'maternal comfort questionnaire score']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0860096', 'cui_str': 'Primigravida (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0474368', 'cui_str': 'Labor Pain'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963897', 'cui_str': 'Low birth weight baby'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0022871', 'cui_str': 'Labor Stage, First'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",200.0,0.0582156,The tolerance of pain was better in the study group as shown by NPIS (p < 0.001) and PBOS scores (p < 0.0001).,"[{'ForeName': 'Chethana', 'Initials': 'C', 'LastName': 'Bolanthakodi', 'Affiliation': 'Department of OBG, Father Muller Medical College, Mangalore, India.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Raghunandan', 'Affiliation': 'Department of OBG, Lady Hardinge Medical College, New Delhi, India.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Saili', 'Affiliation': 'Department of Paediatrics, and Lady Hardinge Medical College, New Delhi, India.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Mondal', 'Affiliation': 'Department of Physiology, Lady Hardinge Medical College, New Delhi, India.'}, {'ForeName': 'Pikee', 'Initials': 'P', 'LastName': 'Saxena', 'Affiliation': 'Department of OBG, Lady Hardinge Medical College, New Delhi, India.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2018.0079']
1872,30146902,Conventional vs 3-Dimensional Printed Cast Wear Comfort.,"Background:  The objective of this study was to determine the functionality of 3-dimensional (3D) printed orthoses for upper extremity immobilization compared with conventional immobilization.  Methods:  Twelve healthy volunteers were fitted with a 3D custom printed short arm cast and a short arm fiberglass cast in separate sessions. The Jebsen Hand Function Test (JHFT) was used to test function and dexterity in each cast. All volunteers completed a modified version of the Patient-Rated Wrist Evaluation (PRWE). Skin complications were recorded.  Results:  There were no significant differences during the JHFT between casts, although one-third of the participants in the 3D cast could perform the tasks in a normal time, which they could not in the fiberglass cast. The average PRWE function score was lower in the 3D cast group than in the fiberglass group (45.5 vs. 80.8). Minor skin irritation was noted in 42% of patients in the fiberglass cast group compared with only 1 patient (8%) in the 3D cast group. One patient in the fiberglass group required a cast change due to inappropriate fit.  Conclusions:  Both casting techniques demonstrate similar objective function based on the JHFT. Patient satisfaction, comfort, and perceived function are superior in the 3D printed casts.",2020,"Patient satisfaction, comfort, and perceived function are superior in the 3D printed casts.",['Twelve healthy volunteers'],"['Conventional vs 3-Dimensional Printed Cast Wear Comfort', 'JHFT', 'conventional immobilization']","['Minor skin irritation', 'average PRWE function score', 'Skin complications', 'Patient satisfaction, comfort, and perceived function']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}]","[{'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation (disorder)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",12.0,0.0726821,"Patient satisfaction, comfort, and perceived function are superior in the 3D printed casts.","[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': 'Rothman Institute and Jefferson Medical College, Philadelphia, PA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Rothman Institute and Jefferson Medical College, Philadelphia, PA, USA.'}, {'ForeName': 'Kaela', 'Initials': 'K', 'LastName': 'Frizzell', 'Affiliation': 'Philadelphia College of Osteopathic Medicine, PA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Watkins', 'Affiliation': 'Rothman Institute and Jefferson Medical College, Philadelphia, PA, USA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Beredjiklian', 'Affiliation': 'Rothman Institute and Jefferson Medical College, Philadelphia, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rivlin', 'Affiliation': 'Rothman Institute and Jefferson Medical College, Philadelphia, PA, USA.'}]","Hand (New York, N.Y.)",['10.1177/1558944718795291']
1873,29978276,The effects of different injection techniques of botulinum toxin a in post-stroke patients with plantar flexor spasticity.,"The purpose of this study was to compare the effects of different injection technique guidance with electrical stimulation (ES) vs ultrasonography (USG) of botulinum toxin A injection (BoNT A) in post-stroke patients with plantar flexor spasticity. Forty chronic post-stroke patients with plantar flexor spasticity and who were able to walk were included in the study. They were randomized into two groups: in 20 patients the BoNT A injection was applied with the guidance of ES and in 20 patients with the guidance of USG by the same physician. Gastrocnemius, soleus, and tibialis posterior were injected. Spasticity was evaluated by ashworth scale; the functional status was evaluated by ankle goniometry for range of motion, Brunnstrom stages, Barthel Index, and 10-m walk test before the treatment, 2nd week, and 3rd month after the treatment. Statistical significance was defined as p < 0.05. Two groups were similar in respect to demographical and clinical features. In both groups, walking speed and range of motion increased significantly after the treatment. When the two groups were compared at 3rd month after the treatment; range of motion of the ankle joint plantar flexion and dorsiflexion when knee in extension showed a significant difference between the two groups. Ashworth scale, Brunnstrom stages, Barthel index, walking speed tests, and other ankle goniometry for range of motion showed no statistically significant difference between two groups. We can conclude that USG and ES guidence are both effective injection techniques when applying BoNT A to ankle plantar flexor muscles.",2020,"In both groups, walking speed and range of motion increased significantly after the treatment.","['Forty chronic post-stroke patients with plantar flexor spasticity and who were able to walk were included in the study', 'post-stroke patients with plantar flexor spasticity']","['botulinum toxin', 'injection technique guidance with electrical stimulation (ES) vs ultrasonography (USG']","['range of motion of the ankle joint plantar flexion and dorsiflexion', 'Gastrocnemius, soleus, and tibialis posterior', 'walking speed and range of motion', 'Spasticity', 'Ashworth scale, Brunnstrom stages, Barthel index, walking speed tests, and other ankle goniometry for range of motion']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C2712089', 'cui_str': 'Able to walk (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]","[{'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0003087', 'cui_str': 'Ankle Syndesmosis'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion, function (observable entity)'}, {'cui': 'C0224463', 'cui_str': 'Tibialis posterior muscle structure'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0222045'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}]",40.0,0.0200417,"In both groups, walking speed and range of motion increased significantly after the treatment.","[{'ForeName': 'Isil Fazilet', 'Initials': 'IF', 'LastName': 'Turna', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Acıbadem Mehmet Ali Aydınlar University Atakent Hospital, Atakent district, 221.street, Bosphorus city, Saraybahce evleri, 5/12, Halkali, Istanbul, Turkey. isilturna@gmail.com.'}, {'ForeName': 'Belgin', 'Initials': 'B', 'LastName': 'Erhan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Gaziosmanpaşa Taksim Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Necibe Berrin', 'Initials': 'NB', 'LastName': 'Gunduz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Onder', 'Initials': 'O', 'LastName': 'Turna', 'Affiliation': 'Department of Radiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training Research Hospital, Istanbul, Turkey.'}]",Acta neurologica Belgica,['10.1007/s13760-018-0969-x']
1874,30171777,Evaluation of postoperative pain intensity following occlusal reduction in teeth associated with symptomatic irreversible pulpitis and symptomatic apical periodontitis: a randomized clinical study.,"AIM


To assess the effect of occlusal reduction on postoperative pain following two visits root canal treatment in posterior mandibular teeth with symptomatic irreversible pulpitis and symptomatic apical periodontitis in a randomized clinical trial.
METHODOLOGY


This trial was conducted in the outpatient clinic of the Endodontic Department of the Faculty of Oral and Dental Medicine, Cairo University in Egypt. Forty-four-patients diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis were randomly assigned into two equal groups. The occlusal surfaces of teeth in the intervention group were reduced; whilst those assigned to the control group were left intact. Canal instrumentation was completed in the first visit using Revo-S rotary nickel-titanium files, and pain intensity was assessed using a visual analogue scale (VAS) at 6, 12, 24 and 48 h. Canal filling was completed 7 days later, and pain intensity was assessed at 6 and 12 h. A placebo was given and analgesics were prescribed to be administered in case of severe postoperative pain. Data were analysed using Independent t-test, chi-square and Fisher Exact tests.
RESULTS


The mean pain scores within the two groups were associated with a significant continuous decrease over time. Following both instrumentation and canal filling, the mean pain scores in the intervention group were lower than those in the control group at all follow-up periods and this difference was only significant at 12 h (P = 0.021 and P = 0.015, respectively).
CONCLUSIONS


Occlusal reduction reduced levels of postoperative pain in posterior mandibular teeth with symptomatic pulpitis and apical periodontitis only 12 h following both canal preparation and root filling.",2019,"Following both instrumentation and canal filling, the mean pain scores in the intervention group were lower than those in the control group at all follow-up periods and this difference was only significant at 12 h (P = 0.021 and P = 0.015, respectively).
","['teeth associated with symptomatic irreversible pulpitis and symptomatic apical periodontitis', 'Forty-four-patients diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis', 'outpatient clinic of the Endodontic Department of the Faculty of Oral and Dental Medicine, Cairo University in Egypt', 'posterior mandibular teeth with symptomatic pulpitis and apical periodontitis', 'posterior mandibular teeth with symptomatic irreversible pulpitis and symptomatic apical periodontitis']","['occlusal reduction', 'visits root canal treatment', 'placebo']","['postoperative pain', 'Canal filling', 'mean pain scores', 'pain intensity']","[{'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C4039735', 'cui_str': 'Symptomatic irreversible pulpitis (disorder)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0031030', 'cui_str': 'Periodontitis, Apical'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0227029', 'cui_str': 'Structure of mandibular teeth'}, {'cui': 'C0034103', 'cui_str': 'Inflammation, Endodontic'}]","[{'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.212602,"Following both instrumentation and canal filling, the mean pain scores in the intervention group were lower than those in the control group at all follow-up periods and this difference was only significant at 12 h (P = 0.021 and P = 0.015, respectively).
","[{'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Emara', 'Affiliation': 'Department of Endodontics, Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Abou El Nasr', 'Affiliation': 'Department of Endodontics, Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'El Boghdadi', 'Affiliation': 'Department of Endodontics, Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt.'}]",International endodontic journal,['10.1111/iej.13012']
1875,30153096,Hydroxycarbamide Plus Aspirin Versus Aspirin Alone in Patients With Essential Thrombocythemia Age 40 to 59 Years Without High-Risk Features.,"PURPOSE


Cytoreductive therapy is beneficial in patients with essential thrombocythemia (ET) at high risk of thrombosis. However, its value in those lacking high-risk features remains unknown. This open-label, randomized trial compared hydroxycarbamide plus aspirin with aspirin alone in patients with ET age 40 to 59 years and without high-risk factors or extreme thrombocytosis.
PATIENTS AND METHODS


Patients were age 40 to 59 years and lacked a history of ischemia, thrombosis, embolism, hemorrhage, extreme thrombocytosis (platelet count ≥ 1,500 × 10 9 /L), hypertension, or diabetes requiring therapy. In all, 382 patients were randomly assigned 1:1 to hydroxycarbamide plus aspirin or aspirin alone. The composite primary end point was time to arterial or venous thrombosis, serious hemorrhage, or death from vascular causes. Secondary end points were time to first arterial or venous thrombosis, first serious hemorrhage, death, incidence of transformation, and patient-reported quality of life.
RESULTS


After a median follow-up of 73 months and a total follow-up of 2,373 patient-years, there was no significant difference between the arms in the likelihood of patients reaching the primary end point (hazard ratio, 0.98; 95% CI, 0.42 to 2.25;  P  = 1.0). The incidence of significant vascular events was low, at 0.93 per 100 patient-years (95% CI, 0.61 to 1.41). There were also no differences in overall survival; in the composite end point of transformation to myelofibrosis, acute myeloid leukemia, or myelodysplasia; in adverse events; or in patient-reported quality of life.
CONCLUSION


In patients with ET age 40 to 59 years and lacking high-risk factors for thrombosis or extreme thrombocytosis, preemptive addition of hydroxycarbamide to aspirin did not reduce vascular events, myelofibrotic transformation, or leukemic transformation. Patients age 40 to 59 years without other clinical indications for treatment (such as previous thrombosis or hemorrhage) who have a platelet count < 1,500 × 10 9 /L should not receive cytoreductive therapy.",2018,"The incidence of significant vascular events was low, at 0.93 per 100 patient-years (95% CI, 0.61 to 1.41).","['patients with essential thrombocythemia (ET) at high risk of thrombosis', '382 patients', 'Patients and Methods Patients were age 40 to 59 years and lacked a history of ischemia, thrombosis, embolism, hemorrhage, extreme thrombocytosis (platelet count ≥ 1,500 × 10 9 /L), hypertension, or diabetes requiring therapy', 'patients with ET age 40 to 59 years and without high-risk factors or extreme thrombocytosis', 'Patients With Essential Thrombocythemia Age 40 to 59 Years', 'patients with ET age 40 to 59 years and lacking high-risk factors for thrombosis or extreme thrombocytosis, preemptive addition of', 'Patients age 40 to 59 years without other clinical indications for treatment (such as previous thrombosis or hemorrhage) who have a platelet count < 1,500 × 10 9 /L should not receive cytoreductive therapy']","['hydroxycarbamide plus aspirin or aspirin alone', 'aspirin', 'Hydroxycarbamide Plus Aspirin Versus Aspirin', 'hydroxycarbamide to aspirin', 'hydroxycarbamide plus aspirin']","['incidence of significant vascular events', 'time to first arterial or venous thrombosis, first serious hemorrhage, death, incidence of transformation, and patient-reported quality of life', 'quality of life', 'time to arterial or venous thrombosis, serious hemorrhage, or death from vascular causes', 'overall survival', 'acute myeloid leukemia, or myelodysplasia; in adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040028', 'cui_str': 'Thrombocytosis, Primary'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0836924', 'cui_str': 'Thrombocythemia'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034380'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",382.0,0.131016,"The incidence of significant vascular events was low, at 0.93 per 100 patient-years (95% CI, 0.61 to 1.41).","[{'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Godfrey', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Campbell', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'MacLean', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Buck', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Temple', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Bridget S', 'Initials': 'BS', 'LastName': 'Wilkins', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Nangalia', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Grinfeld', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Mary Frances', 'Initials': 'MF', 'LastName': 'McMullin', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Cecily', 'Initials': 'C', 'LastName': 'Forsyth', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Kiladjian', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Anthony R', 'Initials': 'AR', 'LastName': 'Green', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'Claire N', 'Initials': 'CN', 'LastName': 'Harrison', 'Affiliation': ""Anna L. Godfrey, Jacob Grinfeld, and Anthony R. Green, Cambridge University Hospitals National Health Service (NHS) Foundation Trust; Peter J. Campbell and Jyoti Nangalia, Wellcome Trust Sanger Institute, Hinxton; Cathy MacLean, Julia Cook, Julie Temple, and Anthony R. Green, University of Cambridge; Anthony R. Green, Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, Cambridge; Georgina Buck, University of Oxford, Oxford; Bridget S. Wilkins and Claire N. Harrison, Guy's and St Thomas' NHS Foundation Trust, London; Keith Wheatley, University of Birmingham, Birmingham; Mary Frances McMullin, Queen's University Belfast, Belfast, United Kingdom; Cecily Forsyth, Gosford Hospital, Gosford, and Australasian Leukaemia and Lymphoma Group, Australia; and Jean-Jacques Kiladjian, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2018.78.8414']
1876,31649135,"Health-Related Quality of Life in MONARCH 2: Abemaciclib plus Fulvestrant in Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer After Endocrine Therapy.","BACKGROUND


In the phase III MONARCH 2 study (NCT02107703), abemaciclib plus fulvestrant significantly improved progression-free survival (PFS) versus placebo plus fulvestrant in patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer (ABC). This study assessed patient-reported pain, global health-related quality of life (HRQoL), functioning, and symptoms.
MATERIALS AND METHODS


Abemaciclib or placebo (150 p.o. mg twice daily) plus fulvestrant (500 mg, per label) were randomly assigned (2:1). The modified Brief Pain Inventory, Short Form (mBPI-sf); European Organization for Research and Treatment of Cancer (EORTC) QoL Core 30 (QLQ-C30); and Breast Cancer Questionnaire (QLQ-BR23) assessed outcomes. Data were collected at baseline, cycle 2, every two cycles 3-13, thereafter at every three cycles, and 30 days postdiscontinuation. Longitudinal mixed regression and Cox proportional hazards models assessed postbaseline change and time to sustained deterioration (TTSD) by study arm.
RESULTS


On-treatment HRQoL scores were consistently maintained from baseline and similar between arms. Patients in the abemaciclib arm ( n  = 446) experienced a 4.9-month delay in pain deterioration (mBPI-sf), compared with the control arm ( n  = 223), and significantly greater TTSD on the mBPI-sf and analgesic use (hazard ratio, 0.76; 95% CI, 0.59-0.98) and QLQ-C30 pain item (hazard ratio, 0.62; 95% CI, 0.48-0.79). TTSD for functioning and most symptoms significantly favored the abemaciclib arm, including fatigue, nausea and vomiting, and cognitive and social functioning. Only diarrhea significantly favored the control arm (hazard ratio, 1.60; 95% CI, 1.20-2.10).
CONCLUSION


HRQoL was maintained on abemaciclib plus fulvestrant. Alongside superior PFS and manageable safety profile, results support treatment with abemaciclib plus fulvestrant in a population of patients with endocrine-resistant HR+, HER2-negative ABC.
IMPLICATIONS FOR PRACTICE


In MONARCH 2, abemaciclib plus fulvestrant demonstrated superior efficacy and a manageable safety profile for patients with in hormone receptor-positive (HR+), HER2-negative (-) advanced breast cancer (ABC). Impact on health-related quality of life (HRQoL) is important to consider, given the palliative nature of ABC treatment. In this study, abemaciclib plus fulvestrant, compared with placebo plus fulvestrant, significantly delayed sustained deterioration of pain and other patient-reported symptoms (including fatigue, nausea, vomiting), and social and cognitive functioning. Combined with demonstrated clinical benefit and tolerability, the stabilization of patient-reported symptoms and HRQoL further supports abemaciclib plus fulvestrant as a desirable treatment option in endocrine resistant, HR+, HER2- ABC.",2019,"TTSD for functioning and most symptoms significantly favored the abemaciclib arm, including fatigue, nausea and vomiting, and cognitive and social functioning.","['patients with endocrine-resistant HR+, HER2-negative ABC', 'Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer', 'patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer (ABC', 'patients with in hormone receptor-positive (HR+), HER2-negative (-) advanced breast cancer (ABC', 'Cancer (EORTC']","['TTSD', 'Fulvestrant', 'abemaciclib plus fulvestrant', 'placebo', 'placebo plus fulvestrant', 'fulvestrant']","['HRQoL', '4.9-month delay in pain deterioration (mBPI-sf', 'diarrhea', 'progression-free survival (PFS', 'health-related quality of life (HRQoL', 'delayed sustained deterioration of pain and other patient-reported symptoms (including fatigue, nausea, vomiting), and social and cognitive functioning', 'pain, global health-related quality of life (HRQoL), functioning, and symptoms', 'HRQoL scores', 'fatigue, nausea and vomiting, and cognitive and social functioning', 'TTSD on the mBPI-sf and analgesic use', 'QLQ-C30 pain item', 'QoL Core 30 (QLQ-C30); and Breast Cancer Questionnaire (QLQ-BR23']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.172778,"TTSD for functioning and most symptoms significantly favored the abemaciclib arm, including fatigue, nausea and vomiting, and cognitive and social functioning.","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Kaufman', 'Affiliation': 'University of Vermont Cancer Center, University of Vermont Medical Center, Burlington, Vermont, USA peter.kaufman@uvmhealth.org.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei Cancer Center, Seoul, Republic of Korea.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Grischke', 'Affiliation': ""Department of Women's Health, University Hospital Tübingen, Tübingen, Germany.""}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Andre', 'Affiliation': 'Eli Lilly and Company, Paris, France.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Stoffregen', 'Affiliation': 'Eli Lilly and Company, Bad Homburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Shekarriz', 'Affiliation': 'Eli Lilly and Company, Bad Homburg, Germany.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Price', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Gebra Cuyun', 'Initials': 'GC', 'LastName': 'Carter', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0551']
1877,30037647,"Continuous low-dose antibiotic prophylaxis for adults with repeated urinary tract infections (AnTIC): a randomised, open-label trial.","BACKGROUND


Repeated symptomatic urinary tract infections (UTIs) affect 25% of people who use clean intermittent self-catheterisation (CISC) to empty their bladder. We aimed to determine the benefits, harms, and cost-effectiveness of continuous low-dose antibiotic prophylaxis for prevention of recurrent UTIs in adult users of CISC.
METHODS


In this randomised, open-label, superiority trial, we enrolled participants from 51 UK National Health Service organisations. These participants were community-dwelling (as opposed to hospital inpatient) users of CISC with recurrent UTIs. We randomly allocated participants (1:1) to receive either antibiotic prophylaxis once daily (prophylaxis group) or no prophylaxis (control group) for 12 months by use of an internet-based system with permuted blocks of variable length. Trial and laboratory staff who assessed outcomes were masked to allocation but participants were aware of their treatment group. The primary outcome was the incidence of symptomatic, antibiotic-treated UTIs over 12 months. Participants who completed at least 6 months of follow-up were assumed to provide a reliable estimate of UTI incidence and were included in the analysis of the primary outcome. Change in antimicrobial resistance of urinary and faecal bacteria was monitored as a secondary outcome. The AnTIC trial is registered at ISRCTN, number 67145101; and EudraCT, number 2013-002556-32.
FINDINGS


Between Nov 25, 2013, and Jan 29, 2016, we screened 1743 adult users of CISC for eligibility, of whom 404 (23%) participants were enrolled between Nov 26, 2013, and Jan 31, 2016. Of these 404 participants, 203 (50%) were allocated to receive prophylaxis and 201 (50%) to receive no prophylaxis. 1339 participants were excluded before randomisation. The primary analysis included 181 (89%) adults allocated to the prophylaxis group and 180 (90%) adults in the no prophylaxis (control) group. 22 participants in the prophylaxis group and 21 participants in the control group were not included in the primary analysis because they were missing follow-up data before 6 months. The incidence of symptomatic antibiotic-treated UTIs over 12 months was 1·3 cases per person-year (95% CI 1·1-1·6) in the prophylaxis group and 2·6 (2·3-2·9) in the control group, giving an incidence rate ratio of 0·52 (0·44-0·61; p<0·0001), indicating a 48% reduction in UTI frequency after treatment with prophylaxis. Use of prophylaxis was well tolerated: we recorded 22 minor adverse events in the prophylaxis group related to antibiotic prophylaxis during the study, predominantly gastrointestinal disturbance (six participants), skin rash (six participants), and candidal infection (four participants). However, resistance against the antibiotics used for UTI treatment was more frequent in urinary isolates from the prophylaxis group than in those from the control group at 9-12 months of trial participation (nitrofurantoin 12 [24%] of 51 participants from the prophylaxis group vs six [9%] of 64 participants from the control group with at least one isolate; p=0·038), trimethoprim (34 [67%] of 51 vs 21 [33%] of 64; p=0·0003), and co-trimoxazole (26 [53%] of 49 vs 15 [24%] of 62; p=0·002).
INTERPRETATION


Continuous antibiotic prophylaxis is effective in reducing UTI frequency in CISC users with recurrent UTIs, and it is well tolerated in these individuals. However, increased resistance of urinary bacteria is a concern that requires surveillance if prophylaxis is started.
FUNDING


UK National Institute for Health Research.",2018,"p<0·0001), indicating a 48% reduction in UTI frequency after treatment with prophylaxis.","['predominantly gastrointestinal disturbance (six participants), skin rash (six participants), and candidal infection (four participants', 'adult users of CISC', '1339 participants were excluded before randomisation', 'adults with repeated urinary tract infections (AnTIC', 'The primary analysis included 181 (89%) adults allocated to the prophylaxis group and 180 (90%) adults in the no prophylaxis (control) group', 'CISC users with recurrent UTIs', 'participants were community-dwelling (as opposed to hospital inpatient) users of CISC with recurrent UTIs', '22 participants in the prophylaxis group and 21 participants in the control group were not included in the primary analysis because they were missing follow-up data before 6 months', 'Between Nov 25, 2013, and Jan 29, 2016, we screened 1743 adult users of CISC for eligibility, of whom 404 (23%) participants were enrolled between Nov 26, 2013, and Jan 31, 2016', '404 participants, 203 (50', 'enrolled participants from 51 UK National Health Service organisations', 'people who use clean intermittent self-catheterisation (CISC) to empty their bladder']","['antibiotic prophylaxis once daily (prophylaxis group) or no prophylaxis (control group) for 12 months by use of an internet-based system with permuted blocks of variable length', 'trimethoprim', 'continuous low-dose antibiotic prophylaxis', 'Continuous low-dose antibiotic prophylaxis']","['UTI frequency', 'tolerated', 'incidence of symptomatic, antibiotic-treated UTIs', 'incidence rate ratio of 0·52', 'antimicrobial resistance of urinary and faecal bacteria', 'incidence of symptomatic antibiotic-treated UTIs']","[{'cui': 'C0232459', 'cui_str': 'Impaired digestion'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0006840', 'cui_str': 'Moniliasis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0473154', 'cui_str': 'Clean intermittent self-catheterization (procedure)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}]","[{'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}]",1339.0,0.194261,"p<0·0001), indicating a 48% reduction in UTI frequency after treatment with prophylaxis.","[{'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Fisher', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. Electronic address: holly.fisher@newcastle.ac.uk.'}, {'ForeName': 'Yemi', 'Initials': 'Y', 'LastName': 'Oluboyede', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chadwick', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Fattah', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Brennand', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Fader', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Harrison', 'Affiliation': 'Department of Urology, Mid-Yorkshire Hospitals NHS Trust, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hilton', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larcombe', 'Affiliation': 'Skerne Medical Centre, Sedgefield, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'McClurg', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': ""N'Dow"", 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ternent', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nikesh', 'Initials': 'N', 'LastName': 'Thiruchelvam', 'Affiliation': 'Department of Urology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Timoney', 'Affiliation': 'Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Walton', 'Affiliation': 'Department of Microbiology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'von Wilamowitz-Moellendorff', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wilkinson', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wood', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pickard', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30279-2']
1878,30125376,"The NACSTOP Trial: A Multicenter, Cluster-Controlled Trial of Early Cessation of Acetylcysteine in Acetaminophen Overdose.","Historically, intravenous acetylcysteine has been delivered at a fixed dose and duration of 300 mg/kg over 20 to 21 hours to nearly every patient deemed to be at any risk for hepatotoxicity following acetaminophen overdose. We investigated a 12-hour treatment regimen for selected low-risk patients. This was a multicenter, open-label, cluster-controlled trial at six metropolitan emergency departments. We enrolled subjects following single or staggered acetaminophen overdose with normal serum alanine transaminase (ALT) and creatinine on presentation and at 12 hours, and less than 20 mg/L acetaminophen at 12 hours. Patients were allocated to intervention (250 mg/kg over 12-hour) or control (300 mg/kg over 20-hour) regimens by site. The primary outcome was incidence of ""hepatic injury"" 20 hours following initiation of acetylcysteine treatment, defined as ALT doubling and peak ALT greater than 100 IU/L, indicating the need for further antidotal treatment. Secondary outcomes included incidence of hepatotoxicity (ALT > 1,000 IU/L), peak international normalized ratio (INR), and adverse drug reactions. Of the 449 acetaminophen overdoses receiving acetylcysteine, 100 were recruited to the study. Time to acetylcysteine (median 7 hours [interquartile ratio 6,12] versus 7 hours [6,10]) and initial acetaminophen (124 mg/L [58,171] versus 146 mg/L [66,204]) were similar between intervention and control groups. There was no difference in ALT (18 IU/L [13,22] versus 16 IU/L [13,21]) or INR (1.2 versus 1.2) 20 hours after starting acetylcysteine between groups. No patients developed hepatic injury or hepatotoxicity in either group (odds ratio 1.0 [95% confidence interval 0.02, 50]). No patients represented with liver injury, none died, and 96 of 96 were well at 14-day telephone follow-up. Conclusion: Discontinuing acetylcysteine based on laboratory testing after 12 hours of treatment is feasible and likely safe in selected patients at very low risk of liver injury from acetaminophen overdose.",2019,"No patients developed hepatic injury or hepatotoxicity in either group (odds ratio 1.0 [95% confidence interval 0.02, 50]).","['selected patients at very low risk of liver injury from acetaminophen overdose', 'selected low-risk patients', 'enrolled subjects following single or staggered acetaminophen overdose with normal serum alanine transaminase (ALT) and creatinine on presentation and at 12 hours, and less than 20 mg', '449 acetaminophen overdoses receiving acetylcysteine, 100 were recruited to the study', 'six metropolitan emergency departments']","['Discontinuing acetylcysteine', 'L acetaminophen', 'acetaminophen', 'acetylcysteine', 'ALT']","['incidence of hepatotoxicity (ALT > 1,000 IU/L), peak international normalized ratio (INR), and adverse drug reactions', 'hepatic injury or hepatotoxicity', 'incidence of ""hepatic injury"" 20 hours following initiation of acetylcysteine treatment, defined as ALT doubling and peak ALT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}, {'cui': 'C0572025', 'cui_str': 'Acetaminophen overdose'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001899', 'cui_str': 'Alanine Aminotransferase'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0439457', 'cui_str': 'milliinternational unit/milliliter'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]",6.0,0.181442,"No patients developed hepatic injury or hepatotoxicity in either group (odds ratio 1.0 [95% confidence interval 0.02, 50]).","[{'ForeName': 'Anselm', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'School of Clinical Sciences, Monash University, Victoria, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McNulty', 'Affiliation': 'Department of Emergency Medicine, Blacktown and Mount Druitt Hospitals, Western Sydney Toxicology Service, NSW, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Emergency Department and Department of Medicine, Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sivilotti', 'Affiliation': ""Departments of Emergency and Biomedical & Molecular Sciences, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Greene', 'Affiliation': 'Victorian Poisons Information Center and Austin Toxicology Service, Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'Naren', 'Initials': 'N', 'LastName': 'Gunja', 'Affiliation': 'Western Sydney Toxicology Service, Sydney Medical School, NSW, Australia.'}, {'ForeName': 'Zeff', 'Initials': 'Z', 'LastName': 'Koutsogiannis', 'Affiliation': 'Victorian Poisons Information Center and Austin Toxicology Service, Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'Andis', 'Initials': 'A', 'LastName': 'Graudins', 'Affiliation': 'Monash Toxicology Service and Monash Emergency Research Collaborative, Dandenong Hospital, School of Clinical Sciences, Monash University, Victoria, Australia.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30224']
1879,31560794,Effects of a toothpaste containing 0.3% triclosan on periodontal parameters of subjects enrolled in a regular maintenance program: A secondary analysis of a 2-year randomized clinical trial.,"BACKGROUND


The triclosan-containing dentifrices are effective in controlling biofilm formation and maintaining gingival health; however, there is limited information on their effects during the periodontal maintenance phase. Therefore, the aim of this study was to evaluate the clinical effects of a toothpaste containing 0.3% triclosan on the periodontal parameters of subjects that have been treated for peri-implantitis and were enrolled in a regular maintenance program.
METHODS


Subjects presenting at least one implant with peri-implantitis and received surgical anti-infective therapy were selected. Sixty days post-surgery (baseline), subjects were randomized into two groups: (1) toothpaste containing 0.3% triclosan + 2.0% PVM/MA copolymer + 1450 ppm fluoride (test) or (2) toothpaste containing 1450 ppm fluoride (control), and were instructed to brush with the assigned toothpaste twice/day for 2 years. They received clinical monitoring at baseline, 3, 6, 12, 18, and 24 months, and professional maintenance every 3 months.
RESULTS


Eighty-eight subjects with natural teeth were enrolled in the study (Test, n = 39; Control, n = 49). The test group showed a greater reduction in the percentage of sites exhibiting bleeding on probing (primary outcome) and lower levels of plaque in comparison with the control group after 24 months (P < 0.05). The mean percentage of sites with probing depth ≥5 mm was reduced over the course of the study only in the test group (P < 0.05).
CONCLUSION


A toothpaste containing 0.3% triclosan was more effective than a regular fluoride toothpaste in improving the periodontal clinical condition around natural teeth of periodontally healthy subjects enrolled in a regular maintenance program for 2 years.",2020,The test group showed a greater reduction in the percentage of sites exhibiting bleeding on probing (primary outcome) and lower levels of plaque in comparison with the control group after 24 months (p<0.05).,"['periodontally healthy subjects enrolled in a regular maintenance program for 2 years', 'subjects enrolled in a regular maintenance program', 'Subjects presenting at least one implant with peri-implantitis and received surgical anti-infective therapy were selected', 'Eighty-eight subjects with natural teeth were enrolled in the study (Test, n: 39; Control, n:49', 'subjects that have been treated for peri-implantitis and were enrolled in a regular maintenance program']","['toothpaste containing 0.3% triclosan', 'regular fluoride toothpaste', 'i)toothpaste containing 0.3% triclosan+2.0% PVM/MA copolymer (Gantrez™)+1450 ppm fluoride (test) or (ii)toothpaste containing 1450 ppm fluoride (control']","['periodontal clinical condition', 'levels of plaque', 'percentage of sites exhibiting bleeding', 'periodontal parameters']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2936258', 'cui_str': 'Periimplantitis'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1141958', 'cui_str': 'Anti-infective therapy'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0596383', 'cui_str': 'Copolymer'}, {'cui': 'C0118823', 'cui_str': 'Gantrez'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",88.0,0.0368354,The test group showed a greater reduction in the percentage of sites exhibiting bleeding on probing (primary outcome) and lower levels of plaque in comparison with the control group after 24 months (p<0.05).,"[{'ForeName': 'Bernal', 'Initials': 'B', 'LastName': 'Stewart', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Jamil Awad', 'Initials': 'JA', 'LastName': 'Shibli', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Araujo', 'Affiliation': 'School of Dentistry, Maringa University, Maringa, Paraná, Brazil.'}, {'ForeName': 'Luciene Cristina', 'Initials': 'LC', 'LastName': 'Figueiredo', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Fotinos', 'Initials': 'F', 'LastName': 'Panagakos', 'Affiliation': 'Colgate-Palmolive Technology Center, Piscataway, New Jersey, USA.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Matarazzo', 'Affiliation': 'School of Dentistry, Maringa University, Maringa, Paraná, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Mairink', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Onuma', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Faveri', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Retamal-Valdes', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Feres', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.18-0501']
1880,29979912,Physical therapist decision-making in managing plantar heel pain: cases from a pragmatic randomized clinical trial.,"INTRODUCTION


Plantar heel pain (PHP) is a common condition managed by physical therapists that can, at times, be difficult to treat. Management of PHP is complicated by a variety of pathoanatomic features associated with PHP in addition to several treatment approaches with varying efficacy. Although clinical guidelines and clinical trial data support a general approach to management, the current literature is limited in case-specific descriptions of PHP management that addresses unique combinations of pathoanatomical, physical, and psychosocial factors that are associated with PHP.  Purpose : The purpose of this case series is to describe physical therapist decision-making of individualized multimodal treatment for PHP cases presenting with varied clinical presentations. Treatment incorporated clinical guidelines and recent evidence including a combination of manual therapy, patient education, stretching, resistance training, and neurodynamic interventions. A common clinical decision-making framework was used to progress individualized treatment from a focus on symptom modulation initially to increased load tolerance of involved tissues and graded activity. In each case, patients met their individual goals and demonstrated clinically meaningful improvements in pain, function, and global rating of change that were maintained at the 1-2-year follow-up.  Implications : This case series provides details of physical therapist management of a variety of PHP clinical presentations that can be used to complement clinical practice guidelines in the management of PHP.",2020,"In each case, patients met their individual goals and demonstrated clinically meaningful improvements in pain, function, and global rating of change that were maintained at the 1-2-year follow-up.
","['managing plantar heel pain', 'PHP cases presenting with varied clinical presentations']",['Physical therapist decision-making'],"['pain, function, and global rating of change']","[{'cui': 'C0231786', 'cui_str': 'Plantar heel pain (finding)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapists'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0391922,"In each case, patients met their individual goals and demonstrated clinically meaningful improvements in pain, function, and global rating of change that were maintained at the 1-2-year follow-up.
","[{'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'McClinton', 'Affiliation': 'Doctor of Physical Therapy Program, Des Moines University , Des Moines, IA, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Heiderscheit', 'Affiliation': 'Departments of Orthopedics & Rehabilitation and Biomedical Engineering, and Doctor of Physical Therapy Program, University of Wisconsin-Madison , Madison, WI, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'McPoil', 'Affiliation': 'School of Physical Therapy, Regis University , Denver, CO, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Flynn', 'Affiliation': 'School of Physical Therapy, South College , Knoxville, TN, USA.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1490941']
1881,30001288,A Randomized Controlled Trial Comparing Colonoscopic Enema With Additional Oral Preparation as a Salvage for Inadequate Bowel Cleansing Before Colonoscopy.,"GOALS


The goal of this study was to evaluate the noninferiority of colonoscopic enema to additional oral preparation in salvage bowel cleansing for inadequate preparation for a morning colonoscopy.
BACKGROUND


Colonoscopic enema, administering additional cathartics into the right colon through the colonoscope accessory channel, is suggested to rescue poor bowel preparation for a colonoscopy but lacking comparative study.
STUDY


In this prospective, randomized, actively-controlled, parallel group, noninferiority trial, consecutive outpatients and health checkup recipients aged from 19 to 70 years with inappropriate bowel preparation during an elective colonoscopy were enrolled to receive either a colonoscopic enema of 1 L polyethylene glycol (PEG) (enema group) or additional oral intake of 2 L PEG (oral group). The primary endpoint was the proportion of adequate bowel preparation evaluated using the Boston Bowel Preparation Scale.
RESULTS


Overall, 131 participants were randomized. Adequate bowel preparation was achieved in 53% (35/66) of the enema group, which was significantly inferior to the oral group (81.5%; 53/67) with a difference of -28.5% (95% confidence interval, -44.1, -12.9; P=0.001). The largest difference in the proportion of adequate bowel preparation was observed in the right colon (57.8% in the enema group vs. 86.9% in the oral group; P<0.001), followed by the transverse colon (85.9% vs. 98.4%; P=0.017) and the left colon (90.6% vs. 96.7%; P=0.274).
CONCLUSIONS


The colonoscopic enema of 1 L PEG was inferior to the additional oral ingestion of 2 L PEG regarding efficacy as a salvage bowel preparation in adults with inadequate bowel cleansing for colonoscopy.",2019,"Adequate bowel preparation was achieved in 53% (35/66) of the enema group, which was significantly inferior to the oral group (81.5%; 53/67) with a difference of -28.5% (95% confidence interval, -44.1, -12.9; P=0.001).","['adults with inadequate bowel cleansing for colonoscopy', 'consecutive outpatients and health checkup recipients aged from 19 to 70 years with inappropriate bowel preparation during an elective colonoscopy were enrolled to receive either a', '131 participants were randomized']",['colonoscopic enema of 1\u2009L polyethylene glycol (PEG) (enema group) or additional oral intake of 2\u2009L PEG (oral group'],"['proportion of adequate bowel preparation', 'left colon', 'right colon', 'Adequate bowel preparation', 'proportion of adequate bowel preparation evaluated using the Boston Bowel Preparation Scale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0014268', 'cui_str': 'Enematas'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0227388', 'cui_str': 'Left colon structure'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}]",131.0,0.120439,"Adequate bowel preparation was achieved in 53% (35/66) of the enema group, which was significantly inferior to the oral group (81.5%; 53/67) with a difference of -28.5% (95% confidence interval, -44.1, -12.9; P=0.001).","[{'ForeName': 'Hyo-Joon', 'Initials': 'HJ', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine and Gastrointestinal Cancer Center, Division of Gastroenterology.'}, {'ForeName': 'Dong Il', 'Initials': 'DI', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine and Gastrointestinal Cancer Center, Division of Gastroenterology.'}, {'ForeName': 'Soo-Kyung', 'Initials': 'SK', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine and Gastrointestinal Cancer Center, Division of Gastroenterology.'}, {'ForeName': 'Sunyong', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Total Healthcare Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'Taeheon', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Total Healthcare Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'Yunho', 'Initials': 'Y', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, Soonchunhyang University College of Medicine, Cheonan.'}, {'ForeName': 'Chang Soo', 'Initials': 'CS', 'LastName': 'Eun', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Republic of Korea.'}, {'ForeName': 'Dong Soo', 'Initials': 'DS', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Republic of Korea.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001087']
1882,24121755,"Associations of inflammatory markers with AIDS and non-AIDS clinical events after initiation of antiretroviral therapy: AIDS clinical trials group A5224s, a substudy of ACTG A5202.","BACKGROUND


The association of inflammatory biomarkers with clinical events after antiretroviral therapy initiation is unclear.
METHODS


A5202 randomized 1857 treatment-naive subjects to abacavir/lamivudine or tenofovir-DF/emtricitabine with efavirenz or atazanavir/ritonavir. Substudy A5224s measured inflammatory biomarkers on subjects with available plasma from baseline and week 24 or 96. An exploratory analysis of the association of high-sensitivity C-reactive protein, interleukin-6 (IL-6), soluble receptors of tumor necrosis factor α (sTNF)-RI, sTNF-RII, TNF-α, soluble vascular cellular adhesion molecules (sVCAM-1), and soluble intercellular adhesion molecules (sICAM-1) with times to AIDS and to non-AIDS events used Cox proportional hazards models.
RESULTS


Analysis included 244 subjects; 85% men and 48% white non-Hispanic with median age 39 years, HIV-1 RNA of 4.6 log10 copies per milliliter, and CD4 of 240 cells per microliter. Overall, 13 AIDS events (9 opportunistic infections, 3 AIDS-cancers, and 1 recurrent bacterial pneumonia) and 18 non-AIDS events (6 diabetes, 4 cancers, 3 cardiovascular, and 5 pneumonias) occurred. Higher baseline IL-6, sTNF-RI, sTNF-RII, and sICAM-1 were significantly associated with increased risk of AIDS-defining events. Adjustment for baseline HIV-1 RNA did not change results, whereas adjusting for baseline CD4 count left only sTNF-RI and sICAM-1 significantly associated with increased risk. Time-updated values of IL-6, sTNFR-I and II, and sICAM-1 were also associated with an increased risk. For non-AIDS events, only higher baseline high-sensitivity C-reactive protein was significantly associated with increased risk, whereas higher IL-6 was marginally associated with higher risk. Analyses of time-updated biomarker values showed tumor necrosis factor α to be significantly associated with increased risk, even after adjustment for antiretroviral therapy, and CD4 count or HIV-1 RNA.
CONCLUSIONS


Higher levels of several inflammatory biomarkers were independently associated with increased risk of AIDS and non-AIDS events.",2014,"Higher baseline IL-6, sTNF-RI, sTNF-RII, and sICAM-1 were significantly associated with increased risk of AIDS-defining events.","['Analysis included 244 subjects; 85% men and 48% white non-Hispanic with median age 39 years', 'A5202 randomized 1857 treatment-naive subjects to', 'subjects with available plasma from baseline and week 24 or 96']",['abacavir/lamivudine or tenofovir-DF/emtricitabine with efavirenz or atazanavir/ritonavir'],"['risk of AIDS and non-AIDS events', 'Time-updated values of IL-6, sTNFR-I and II, and sICAM-1', 'Overall, 13 AIDS events (9 opportunistic infections, 3 AIDS-cancers, and 1 recurrent bacterial pneumonia', 'CD4 count or HIV-1 RNA', 'Higher baseline IL-6, sTNF-RI, sTNF-RII, and sICAM-1']","[{'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1613391', 'cui_str': 'abacavir / Lamivudine'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic Infections'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0747667', 'cui_str': 'Recurrent bacterial pneumonia'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",1857.0,0.0277565,"Higher baseline IL-6, sTNF-RI, sTNF-RII, and sICAM-1 were significantly associated with increased risk of AIDS-defining events.","[{'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'McComsey', 'Affiliation': ""*Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, OH; †Harvard School of Public Health, Boston, MA; ‡Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA; §Social & Scientific Systems, Inc., Silver Spring, MD; ‖Gilead Sciences, Foster City, CA; ¶GlaxoSmithKline, Research Triangle, NC; #Department of Medicine, Johns Hopkins University, Baltimore, MD; **Frontier Science and Technology Research Foundation, Amherst, NY; ††Department of Geriatric Medicine and Gerontology, Johns Hopkins University, Baltimore, MD; ‡‡Department of Medicine, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA.""}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Kitch', 'Affiliation': ''}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ''}, {'ForeName': 'Camlin', 'Initials': 'C', 'LastName': 'Tierney', 'Affiliation': ''}, {'ForeName': 'Nasreen C', 'Initials': 'NC', 'LastName': 'Jahed', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Melbourne', 'Affiliation': ''}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Ha', 'Affiliation': ''}, {'ForeName': 'Todd T', 'Initials': 'TT', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Bloom', 'Affiliation': ''}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Fedarko', 'Affiliation': ''}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Daar', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/01.qai.0000437171.00504.41']
1883,31651665,Efficacy And Safety Of Sodium Benzoate In The Management Of Hyperammonemia in Decompensated Chronic Liver Disease of the Childhood- A Double Blind Randomised Controlled Trial.,"OBJECTIVE


The objective was to evaluate the efficacy and safety of sodium benzoate in the management of hyperammonemia and hepatic encephalopathy in decompensated chronic liver disease (CLD).
METHODS


It was a prospective, interventional, double-blinded randomized controlled trial conducted from August'2017 to December'2018. Children with decompensated CLD and hyperammonemia were included in the study. Those with ammonia >400 μg/dl, already receiving sodium benzoate or with grade III ascites were excluded. Group A received sodium benzoate (400 mg/kg loading dose followed by 200 mg/kg/day maintenance for 5 days) along with the standard medical therapy (SMT). Group B received SMT with placebo.
RESULTS


A total of 108 episodes of hyperammonemia occurred in 86 patients of whom 16 were excluded. The final analysis included 46 episodes in each group. The median decrease in ammonia from baseline to day 5 was 52 μg/dl in group A versus 42 μg/dl in Group B (p = 0.321). There was a significant decrease in ammonia on days 1 and 2 in Group A as compared to Group B, but not on subsequent days. There was no significant difference in the resolution of HE (57.1% vs 50%;p = 1), but there was higher, albeit insignificant increase in ascites in group A (15.9% vs 4.5%).
CONCLUSION


Addition of sodium benzoate significantly reduced the ammonia levels on the first 2 days of therapy but the effect was not sustained till day 5. The effect of sodium benzoate would probably be more sustained, if higher dosage (400 mg/kg/day) could be used under monitoring of benzoate levels. There was no effect on resolution of HE. Sodium benzoate caused an increasing trend of adverse events with no effect on short-term survival.",2019,"There was no significant difference in the resolution of HE (57.1% vs 50%;p = 1), but there was higher, albeit insignificant increase in ascites in group A (15.9% vs 4.5%).
","['A total of 108 episodes of hyperammonemia occurred in 86 patients of whom 16 were excluded', 'decompensated chronic liver disease (CLD', 'Children with decompensated CLD and hyperammonemia']","['Sodium Benzoate', 'sodium benzoate', 'SMT with placebo', 'Childhood', 'sodium benzoate (400\u200amg/kg loading dose followed by 200\u200amg/kg/day maintenance for 5 days) along with the standard medical therapy (SMT']","['adverse events', 'ammonia', 'ascites', 'median decrease in ammonia', 'resolution of HE', 'ammonia levels']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0220994', 'cui_str': 'Hyperammonemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C0055926', 'cui_str': 'endogenous clonidine-like substance'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0142805', 'cui_str': 'Sodium Benzoate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0201879', 'cui_str': 'Ammonia measurement (procedure)'}]",86.0,0.479932,"There was no significant difference in the resolution of HE (57.1% vs 50%;p = 1), but there was higher, albeit insignificant increase in ascites in group A (15.9% vs 4.5%).
","[{'ForeName': 'Pandey', 'Initials': 'P', 'LastName': 'Snehavardhan', 'Affiliation': 'Department of Pediatric Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Bikrant Bihari', 'Initials': 'BB', 'LastName': 'Lal', 'Affiliation': ''}, {'ForeName': 'Vikrant', 'Initials': 'V', 'LastName': 'Sood', 'Affiliation': ''}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': ''}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Alam', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002521']
1884,31637349,Feedback With Performance Metric Scorecards Improves Resident Satisfaction but Does Not Impact Clinical Performance.,"Objectives


The Emergency Medicine Milestone Project, a framework for assessing competencies, has been used as a method of providing focused resident feedback. However, the emergency medicine milestones do not include specific objective data about resident clinical efficiency and productivity, and studies have shown that milestone-based feedback does not improve resident satisfaction with the feedback process. We examined whether providing performance metric reports to resident physicians improves their satisfaction with the feedback process and their clinical performance.
Methods


We conducted a three-phase stepped-wedge randomized pilot study of emergency medicine residents at a single, urban academic site. In phase 1, all residents received traditional feedback; in phase 2, residents were randomized to receive traditional feedback (control group) or traditional feedback with performance metric reports (intervention group); and in phase 3, all residents received monthly performance metric reports and traditional feedback. To assess resident satisfaction with the feedback process, surveys using 6-point Likert scales were administered at each study phase and analyzed using two-sample t-tests. Analysis of variance in repeated measures was performed to compare impact of feedback on resident clinical performance, specifically patient treatment time (PTT) and patient visits per hour.
Results


Forty-one residents participated in the trial of which 21 were randomized to the intervention group and 20 in the control group. Ninety percent of residents liked receiving the report and 74% believed that it better prepared them for expectations of becoming an attending physician. Additionally, residents randomized to the intervention group reported higher satisfaction (p = 0.01) with the quality of the feedback compared to residents in the control group. However, receiving performance metric reports, regardless of study phase or postgraduate year status, did not affect clinical performance, specifically PTT (183 minutes vs. 177 minutes, p = 0.34) or patients visits per hour (0.99 vs. 1.04, p = 0.46).
Conclusions


While feedback with performance metric reports did not improve resident clinical performance, resident physicians were more satisfied with the feedback process, and a majority of residents expressed liking the reports and felt that it better prepared them to become attending physicians. Residency training programs could consider augmenting feedback with performance metric reports to aide in the transition from resident to attending physician.",2019,"Additionally, residents randomized to the intervention group reported higher satisfaction (p = 0.01) with the quality of the feedback compared to residents in the control group.","['emergency medicine residents at a single, urban academic site', 'Forty-one residents participated in the trial of which 21 were randomized to the intervention group and 20 in the control group']","['traditional feedback (control group) or traditional feedback with performance metric reports (intervention group); and in phase 3, all residents received monthly performance metric reports and traditional feedback', 'traditional feedback']","['patient treatment time (PTT) and patient visits per hour', 'higher satisfaction']","[{'cui': 'C0013964', 'cui_str': 'Emergency Medicine'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0564385', 'cui_str': 'per hour'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",41.0,0.0564265,"Additionally, residents randomized to the intervention group reported higher satisfaction (p = 0.01) with the quality of the feedback compared to residents in the control group.","[{'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Mamtani', 'Affiliation': 'Department of Emergency Medicine Hospital of the University of Pennsylvania Philadelphia PA.'}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Shofer', 'Affiliation': 'Department of Emergency Medicine Hospital of the University of Pennsylvania Philadelphia PA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sackeim', 'Affiliation': 'Department of Emergency Medicine Hospital of the University of Pennsylvania Philadelphia PA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Conlon', 'Affiliation': 'Department of Emergency Medicine Hospital of the University of Pennsylvania Philadelphia PA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Scott', 'Affiliation': 'Department of Emergency Medicine Hospital of the University of Pennsylvania Philadelphia PA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Mills', 'Affiliation': 'Department of Emergency Medicine Columbia University College of Physician and Surgeons New York NY.'}]",AEM education and training,['10.1002/aet2.10348']
1885,31632654,Costs and consequences of the Family Nurse Partnership (FNP) programme in England: evidence from the Building Blocks trial.,"Background:  The Family Nurse Partnership (FNP) is a licensed intensive home visiting intervention programme delivered to teenage mothers which was originally introduced in England in 2006 by the Department of Health and is now provided through local commissioning of public health services and supported by a national unit led by a consortium of partners. The Building Blocks (BB) trial aimed to explore the effectiveness and cost-effectiveness of this programme. This paper reports the results of an economic evaluation of the Building Blocks randomised controlled trial (RCT) based on a cost-consequence approach.  Methods : A large sample of 1618 families was followed-up at various intervals during pregnancy and for two years after birth. A cost-consequence approach was taken to appraise the full range of costs arising from the intervention including both health and social measures of cost alongside the consequences of the trial, specifically, the primary outcomes.  Results : A large number of potential factors were identified that are likely to attract additional costs beyond the implementation costs of the intervention including both health and non-health outcomes.  Conclusion : Given the extensive costs and only small beneficial consequences observed within the two year follow-up period, the cost-consequence model suggests that the FNP intervention is unlikely to be worth the substantial costs and policy makers may wish to consider other options for investment.  Trial registration : ISRCTN23019866 (20/04/2009).",2019,The Family Nurse Partnership (FNP) is a licensed intensive home visiting intervention programme delivered to teenage mothers which was originally introduced in England in 2006 by the Department of Health and is now provided through local commissioning of public health services and supported by a national unit led by a consortium of partners.,[],"['FNP intervention', 'Family Nurse Partnership (FNP) programme', 'Family Nurse Partnership (FNP']",['effectiveness and cost-effectiveness'],[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",1618.0,0.0621001,The Family Nurse Partnership (FNP) is a licensed intensive home visiting intervention programme delivered to teenage mothers which was originally introduced in England in 2006 by the Department of Health and is now provided through local commissioning of public health services and supported by a national unit led by a consortium of partners.,"[{'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Bell', 'Affiliation': 'Health Sciences, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Corbacho', 'Affiliation': 'Health Sciences, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ronaldson', 'Affiliation': 'Health Sciences, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, CF14 4YS, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, CF14 4XN, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Population Health Trials, Cardiff University, Cardiff, CF14 4ER, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'Health Sciences, University of York, UK, York, North Yorkshire, YO10 5DD, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",F1000Research,['10.12688/f1000research.20149.1']
1886,32411014,Ischemic Preconditioning Did Not Affect Central and Peripheral Factors of Performance Fatigability After Submaximal Isometric Exercise.,"The present study was designed to provide further insight into the mechanistic basis for the improved exercise tolerance following ischemic preconditioning (IPC) by investigating key-determinants of performance and perceived fatigability. Using a randomized, counterbalanced, single-blind, sham-controlled, crossover design, 16 males performed an isometric time-to-exhaustion test with the knee extensors at 20% maximal voluntary torque (MVT) after an IPC and a sham treatment (SHAM). Those who improved their time-to-exhaustion following IPC performed a time-matched IPC trial corresponding to the exercise duration of SHAM (IPC tm ). Neuromuscular function was assessed before and after exercise termination during each condition (IPC, IPC tm , and SHAM) to analyze the impact of IPC on performance fatigability and its central and peripheral determinants. Muscle oxygenation (SmO 2 ), muscle activity, and perceptual responses (effort and muscle pain) were recorded during exercise. Performance fatigability as well as its central and peripheral determinants were quantified as percentage pre-post changes in MVT (ΔMVT) as well as voluntary activation (ΔVA) and quadriceps twitch torque evoked by paired electrical stimuli at 100 and 10 Hz (ΔPS100 and ΔPS10⋅PS100 -1  ratio), respectively. Time-to-exhaustion, performance fatigability, its determinants, muscle activity, SmO 2 , and perceptual responses during exercise were not different between IPC and SHAM. However, six participants improved their performance by >10% following IPC (299 ± 71 s) compared to SHAM (253 ± 66 s,  d  = 3.23). The time-matched comparisons (IPC tm  vs. SHAM) indicated that performance fatigability, its determinants, and SmO 2  were not affected, while effort perception seemed to be lower (η p   2  = 0.495) in those who improved their time-to-exhaustion. The longer time-to-exhaustion following IPC seemed to be associated with a lower effort perception (η p   2  = 0.380) and larger impairments in neuromuscular function, i.e., larger ΔMVT, ΔVA, and ΔPS10⋅PS100 -1  ratio ( d  = 0.71, 1.0, 0.92, respectively). IPC did neither affect exercise tolerance, performance fatigability, as well as its central and peripheral determinants, nor muscle activity, SmO 2 , and perceptual responses during submaximal isometric exercise. However, IPC seemed to have an ergogenic effect in a few subjects, which might have resulted from a lower effort perception during exercise. These findings support the assumption that there are 'responders' and 'non-responders' to IPC.",2020,"IPC did neither affect exercise tolerance, performance fatigability, as well as its central and peripheral determinants, nor muscle activity, SmO 2 , and perceptual responses during submaximal isometric exercise.",['16 males performed an'],"['Submaximal Isometric Exercise', 'isometric time-to-exhaustion test with the knee extensors at 20% maximal voluntary torque (MVT) after an IPC and a sham treatment (SHAM', 'IPC', 'Ischemic Preconditioning']","['Fatigability', 'Muscle oxygenation (SmO 2 ), muscle activity, and perceptual responses (effort and muscle pain', 'larger ΔMVT, ΔVA, and ΔPS10⋅PS100 -1  ratio', 'longer time-to-exhaustion', 'voluntary activation (ΔVA) and quadriceps twitch torque evoked by paired electrical stimuli', 'Central and Peripheral Factors of Performance', 'Neuromuscular function', 'exercise tolerance, performance fatigability, as well as its central and peripheral determinants, nor muscle activity, SmO 2 , and perceptual responses', 'Time-to-exhaustion, performance fatigability, its determinants, muscle activity, SmO 2 , and perceptual responses during exercise']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0574401', 'cui_str': 'Samoan language'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}]",16.0,0.157523,"IPC did neither affect exercise tolerance, performance fatigability, as well as its central and peripheral determinants, nor muscle activity, SmO 2 , and perceptual responses during submaximal isometric exercise.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Behrens', 'Affiliation': 'Institute of Sport Science, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Zschorlich', 'Affiliation': 'Institute of Sport Science, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mittlmeier', 'Affiliation': 'Department of Traumatology, Hand and Reconstructive Surgery, University Medicine Rostock, Rostock, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Bruhn', 'Affiliation': 'Institute of Sport Science, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Husmann', 'Affiliation': 'Institute of Sport Science, University of Rostock, Rostock, Germany.'}]",Frontiers in physiology,['10.3389/fphys.2020.00371']
1887,32411007,"Effect of Resistance Training Under Normobaric Hypoxia on Physical Performance, Hematological Parameters, and Body Composition in Young and Older People.","Background


Resistance training (RT) under hypoxic conditions has been used to increase muscular performance under normoxic conditions in young people. However, the effects of RT and thus of RT under hypoxia (RTH) could also be valuable for parameters of physical capacity and body composition across the lifespan. Therefore, we compared the effects of low- to moderate-load RTH with matched designed RT on muscular strength capacity, cardiopulmonary capacity, hematological adaptation, and body composition in young and older people.
Methods


In a pre-post randomized, blinded, and controlled experiment, 42 young (18 to 30 year) and 42 older (60 to 75 year) participants were randomly assigned to RTH or RT (RTH young, RT young, RTH old, RT old). Both groups performed eight resistance exercises (25-40% of 1RM, 3 × 15 repetitions) four times a week over 5 weeks. The intensity of hypoxic air for the RTH was administered individually in regards to the oxygen saturation of the blood (SpO 2 ): ∼80-85%. Changes and differences in maximal isokinetic strength, cardiopulmonary capacity, total hemoglobin mass (tHb), blood volume (BV), fat free mass (FFM), and fat mass (FM) were determined pre-post, and the acute reaction of erythropoietin (EPO) was tested during the intervention.
Results


In all parameters, no significant pre-post differences in mean changes (time × group effects  p  = 0.120 to 1.000) were found between RTH and RT within the age groups. However, within the four groups, isolated significant improvements ( p  < 0.050) of the single groups were observed regarding the muscular strength of the legs and the cardiopulmonary capacity.
Discussion


Although the hypoxic dose and the exercise variables of the resistance training in this study were based on the current recommendations of RTH, the RTH design used had no superior effect on the tested parameters in young and older people in comparison to the matched designed RT under normoxia after a 5-week intervention period. Based on previous RTH-studies as well as the knowledge about RT in general, it can be assumed that the expected higher effects of RTH can may be achieved by changing exercise variables (e.g., longer intervention period, higher loads).",2020,"In all parameters, no significant pre-post differences in mean changes (time × group effects  p  = 0.120 to 1.000) were found between RTH and RT within the age groups.","['young people', 'young and older people', 'Young and Older People', '42 young (18 to 30 year) and 42 older (60 to 75 year) participants']","['Resistance Training Under Normobaric Hypoxia', '\n\n\nResistance training (RT', 'RTH or RT']","['muscular strength of the legs and the cardiopulmonary capacity', 'acute reaction of erythropoietin (EPO', 'Physical Performance, Hematological Parameters, and Body Composition', 'maximal isokinetic strength, cardiopulmonary capacity, total hemoglobin mass (tHb), blood volume (BV), fat free mass (FFM), and fat mass (FM', 'muscular strength capacity, cardiopulmonary capacity, hematological adaptation, and body composition']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]",,0.012693,"In all parameters, no significant pre-post differences in mean changes (time × group effects  p  = 0.120 to 1.000) were found between RTH and RT within the age groups.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Törpel', 'Affiliation': 'Department Health and Physical Activity, Institute III Sport Science, Otto von Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Peter', 'Affiliation': 'Department Health and Physical Activity, Institute III Sport Science, Otto von Guericke University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Schega', 'Affiliation': 'Department Health and Physical Activity, Institute III Sport Science, Otto von Guericke University Magdeburg, Magdeburg, Germany.'}]",Frontiers in physiology,['10.3389/fphys.2020.00335']
1888,29952687,Physiotherapists' experiences with a blended osteoarthritis intervention: a mixed methods study.,"INTRODUCTION


E-Exercise is an effective 12-week blended intervention consisting of around five face-to-face physiotherapy sessions and a web-based application for patients with hip/knee osteoarthritis. In order to facilitate effective implementation of e-Exercise, this study aims to identify physiotherapists' experiences and determinants related to the usage of e-Exercise.  Methods : An explanatory sequential mixed methods design embedded in a randomized controlled trial comparing e-Exercise with usual physiotherapy in patients with hip/knee osteoarthritis. Usage of e-Exercise was based on recruitment rates of 123 physiotherapists allocated to e-Exercise and objective web-based application usage data. Experiences and determinants related to e-Exercise usage were investigated with a questionnaire and clarified with semi-structured interviews.  Results : Of the 123 physiotherapists allocated to e-Exercise, 54 recruited more than one eligible patient, of whom 10 physiotherapists continued using e-Exercise after the study period. Physiotherapists had mixed experiences with e-Exercise. Determinants related to intervention usage were appropriateness, added value, time, workload, professional autonomy, environmental factors, and financial consequences. Physiotherapists recommended to improve the ability to tailor e-Exercise to the individual needs of the patient patients' individual needs.  Discussion : Determinants related to the usage of e-Exercise provided valuable information for the implementation of e-Exercise on broader scale. Most importantly, the flexibility of e-Exercise needs to be improved. Next, there is a need for education on how to integrate an online program within physiotherapy.",2020,"Determinants related to intervention usage were appropriateness, added value, time, workload, professional autonomy, environmental factors, and financial consequences.","['patients with hip/knee osteoarthritis', '123 physiotherapists allocated to e-Exercise, 54 recruited more than one eligible patient, of whom 10 physiotherapists continued using e-Exercise after the study period']","['e-Exercise with usual physiotherapy', 'blended osteoarthritis intervention']","['added value, time, workload, professional autonomy, environmental factors, and financial consequences']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0085518', 'cui_str': 'Professional Autonomy'}]",,0.0450163,"Determinants related to intervention usage were appropriateness, added value, time, workload, professional autonomy, environmental factors, and financial consequences.","[{'ForeName': 'Corelien J J', 'Initials': 'CJJ', 'LastName': 'Kloek', 'Affiliation': 'School of Social and Behavioral Sciences, Tilburg University , Tilburg, The Netherlands.'}, {'ForeName': 'Daniël', 'Initials': 'D', 'LastName': 'Bossen', 'Affiliation': 'ACHIEVE Centre of Expertise, Faculty of Health, Amsterdam University of Applied Sciences , Amsterdam, The Netherlands.'}, {'ForeName': 'Herman J', 'Initials': 'HJ', 'LastName': 'de Vries', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL) , Utrecht, the Netherlands.'}, {'ForeName': 'Dinny H', 'Initials': 'DH', 'LastName': 'de Bakker', 'Affiliation': 'School of Social and Behavioral Sciences, Tilburg University , Tilburg, The Netherlands.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Veenhof', 'Affiliation': 'Department of Rehabilitation, Physical Therapy Science & Sports, Brain Center Rudolf Magnus, University Medical Center Utrecht , Utrecht, the Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'Department of Rehabilitation Medicine & Department of Psychiatry, EMGO Institute, VU University Medical Center Amsterdam , Amsterdam, the Netherlands.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1489926']
1889,31612653,Comparison of Safety and Efficacy of Botox and Neuronox in the Management of Benign Essential Blepharospasm: A Split-face Study.,"PURPOSE


To compare the efficacy and safety of Botox and Neuronox in the management of benign essential blepharospasm (BEB).
METHODS


We performed a triple-masked, randomized control study to compare Botox and Neuronox in 48 eyes of 24 patients with BEB. All 24 patients randomly received Botox or Neuronox in the periorbital region in a masked, randomized split-face manner, keeping the injection sites and doses uniform. The toxin preparation, injection, and clinical evaluations were done by three independent observers. Objective outcome measures included improvement in the severity of spasm, grading of the functional visual status, changes in palpebral fissure height, lagophthalmos, superficial punctate keratitis and Schirmer's test at 2 weeks, 6 weeks, and upon conclusion of the effect of the toxin. Subjective outcome measures included duration of the effect and a forced choice stating which half of the face was better. Evaluations were performed through clinical measurements, external digital photography, and high-definition videography.
RESULTS


The mean duration of relief from spasms was 3.78 months (standard deviation, 1.58 months; range, 1 to 6 months). The improvement in the objective parameters like severity of spasm and functional visual status was statistically significant at the 2-week and 6-week follow-up visits ( p  < 0.001). The changes in palpebral fissure height, lagophthalmos, and superficial punctate keratitis were equally observed in both groups. At 2 and 6 weeks, three of 24 (12.5%) and one of 24 (4%) patients, respectively, reported an unequal effect between the two sides of the face, but this difference was not statistically significant. At final follow-up (conclusion of the toxin effect), patients reported equal effect with no preference for either hemiface. No statistically significant differences were found in the comparative analysis between the Neuronox and Botox groups.
CONCLUSIONS


Neuronox and Botox are comparable in terms of their safety and efficacy in the management of BEB.",2019,The improvement in the objective parameters like severity of spasm and functional visual status was statistically significant at the 2-week and 6-week follow-up visits ( p  < 0.001).,"['48 eyes of 24 patients with BEB', 'Benign Essential Blepharospasm']","['Botox or Neuronox', 'Botox and Neuronox']","['mean duration of relief from spasms', 'palpebral fissure height, lagophthalmos, and superficial punctate keratitis', 'objective parameters like severity of spasm and functional visual status', 'efficacy and safety', ""severity of spasm, grading of the functional visual status, changes in palpebral fissure height, lagophthalmos, superficial punctate keratitis and Schirmer's test"", 'duration of the effect and a forced choice stating which half of the face', 'safety and efficacy']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2930898', 'cui_str': 'Eyelid Twitching'}]","[{'cui': 'C0700702', 'cui_str': 'Botox'}, {'cui': 'C4704930', 'cui_str': 'Neuronox'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0037763', 'cui_str': 'Muscular Spasm'}, {'cui': 'C0423104', 'cui_str': 'Height of palpebral fissure (observable entity)'}, {'cui': 'C0259799', 'cui_str': 'PK - Punctate keratitis'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]",,0.0371821,The improvement in the objective parameters like severity of spasm and functional visual status was statistically significant at the 2-week and 6-week follow-up visits ( p  < 0.001).,"[{'ForeName': 'Sayali', 'Initials': 'S', 'LastName': 'Sane', 'Affiliation': 'Department of Ophthalmic Plastic Surgery, LV Prasad Eye Institute, Hyderabad, India.'}, {'ForeName': 'Mohammad Javed', 'Initials': 'MJ', 'LastName': 'Ali', 'Affiliation': 'Department of Ophthalmic Plastic Surgery, LV Prasad Eye Institute, Hyderabad, India.'}, {'ForeName': 'Milind N', 'Initials': 'MN', 'LastName': 'Naik', 'Affiliation': 'Department of Ophthalmic Plastic Surgery, LV Prasad Eye Institute, Hyderabad, India. milind@drmilindnaik.com.'}]",Korean journal of ophthalmology : KJO,['10.3341/kjo.2016.0123']
1890,31642526,Randomized controlled trial of an applied behavior analytic intervention for food selectivity in children with autism spectrum disorder.,"Food selectivity is a common problem for children with autism spectrum disorder (ASD; Schreck, Williams, & Smith, 2004). Behavior-analytic interventions have the most empirical support for feeding disorders (Sharp, Jaquess, Morton, & Miles, 2011). However, there are no randomized controlled trials that have evaluated its effects with a well-defined cohort of children with ASD. In the current investigation, we randomly assigned 6 young children with ASD and food selectivity to either an applied behavior analytic intervention or a wait-list control. We used a crossover randomized controlled trial to evaluate the effects of a multicomponent applied behavior analytic intervention on independent acceptance and mouth clean of 16 novel foods. We subsequently exposed the wait-list control group to the intervention. We also evaluated the effects of the intervention on individual participants with single-case designs. The percentage of independent acceptance and mouth clean increased for the applied behavior analytic intervention group, but not for the wait-list control group until we implemented the intervention.",2019,"The percentage of independent acceptance and mouth clean increased for the applied behavior analytic intervention group, but not for the wait-list control group until we implemented the intervention.","['children with ASD', 'children with autism spectrum disorder', '16 novel foods', '6 young children with ASD and', 'individual participants with single-case designs', 'children with autism spectrum disorder (ASD']","['applied behavior analytic intervention', 'food selectivity to either an applied behavior analytic intervention or a wait-list control', 'multicomponent applied behavior analytic intervention']",['percentage of independent acceptance and mouth clean'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}]",,0.0781908,"The percentage of independent acceptance and mouth clean increased for the applied behavior analytic intervention group, but not for the wait-list control group until we implemented the intervention.","[{'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Peterson', 'Affiliation': ""University of Nebraska Medical Center's Munroe-Meyer Institute.""}, {'ForeName': 'Cathleen C', 'Initials': 'CC', 'LastName': 'Piazza', 'Affiliation': ""University of Nebraska Medical Center's Munroe-Meyer Institute.""}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Ibañez', 'Affiliation': ""University of Nebraska Medical Center's Munroe-Meyer Institute.""}, {'ForeName': 'Wayne W', 'Initials': 'WW', 'LastName': 'Fisher', 'Affiliation': ""University of Nebraska Medical Center's Munroe-Meyer Institute.""}]",Journal of applied behavior analysis,['10.1002/jaba.650']
1891,31615480,"HABIT efficacy and sustainability trial, a multi-center randomized controlled trial to improve hydroxyurea adherence in youth with sickle cell disease: a study protocol.","BACKGROUND


Hydroxyurea (HU) is recommended as standard practice for youth with sickle cell disease (SCD). Yet, despite its efficacy, HU adherence in adolescents and young adults is often poor. Poor medication adherence increases disease burden, healthcare cost and widens health disparities. Adolescence is a critical time to improve adherence through improved chronic disease self-management. This study aims to test the efficacy of an intervention delivered to youth/parent dyads by community health workers (CHWs), augmented by tailored text messages on HU adherence (primary outcome). Secondary outcomes are intervention sustainability, youth health-related quality of life, self-management responsibility concordance, acute hospital use and self-reported disease symptoms.
METHODS


Hydroxyurea Adherence for Personal Best in Sickle Cell Disease, ""HABIT,"" is a 12 month multi-center randomized controlled trial. One hundred four youth, 10 to 18 years of age prescribed HU who meet eligibility criteria, enrolled with their parent as dyads, will be randomized 1:1 to either the HABIT intervention or to usual clinical care plus education handouts. All subjects will complete clinic visits at months 0, 2, 4, 6 (efficacy component), 9 and 12 (sustainability component) for assessment of HbF biomarker, other hematologic parameters, and to complete questionnaires. In addition, dyads assigned to the HABIT intervention will work with CHWs to identify a daily habit (e.g., brushing teeth) on which to build a HU adherence habit. Tailored daily text message reminders to support the habit will be developed by the dyad in collaboration with the CHWs and sent to parent and youth. At the 6 month visit, the intervention will end and the sustainability portion of the trial will begin. All data analyses will be based on intention to treat with all randomized subjects included in the analyses.
DISCUSSION


Prior retrospective studies demonstrate that a majority of adolescents are poorly adherent to HU. If efficacious, the HABIT intervention has the potential to improve the lives of youth with SCD.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03462511 . Registered March 6, 2018, last updated July 26, 2019.",2019,"Secondary outcomes are intervention sustainability, youth health-related quality of life, self-management responsibility concordance, acute hospital use and self-reported disease symptoms.
","['One hundred four youth, 10 to 18\u2009years of age prescribed HU who meet eligibility criteria, enrolled with their parent as dyads', 'adolescents and young adults', 'youth with sickle cell disease (SCD', 'youth with sickle cell disease']","['Hydroxyurea (HU', 'HABIT intervention or to usual clinical care plus education handouts', 'HABIT intervention', 'intervention delivered to youth/parent dyads by community health workers (CHWs', 'hydroxyurea adherence']","['HABIT efficacy', 'disease burden, healthcare cost and widens health disparities', 'intervention sustainability, youth health-related quality of life, self-management responsibility concordance, acute hospital use and self-reported disease symptoms']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",104.0,0.0982274,"Secondary outcomes are intervention sustainability, youth health-related quality of life, self-management responsibility concordance, acute hospital use and self-reported disease symptoms.
","[{'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Smaldone', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA. ams130@columbia.edu.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Manwani', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Aygun', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Smith-Whitley', 'Affiliation': 'Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Haomiao', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Bruzzese', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Findley', 'Affiliation': 'Mailman School of Public Health, New York, NY, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Massei', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Green', 'Affiliation': 'Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}]",BMC pediatrics,['10.1186/s12887-019-1746-6']
1892,32411025,Memory Retrieval-Extinction Combined With Virtual Reality Reducing Drug Craving for Methamphetamine: Study Protocol for a Randomized Controlled Trial.,"Background


Relapse, often precipitated by drug-associated cues that evoke craving, is a key problem in the treatment of methamphetamine use disorder (MUD). Drug-associated memories play a major role in the maintenance of relapse. Extinction training is a common method for decreasing drug craving by suppressing drug-associated memories. However, the effects are often not permanent, which is evident in form of spontaneous recovery or renewal of cue-elicited responses. Based on memory reconsolidation theory, the retrieval-extinction (R-E) paradigm may be more effective in decreasing spontaneous recovery or renewal responses than extinction. After the original memory reactivated to a labile state, extinction will be introduced within the reconsolidation window, thereby updating drug-associated memories. However, there are still some controversial results, which suggest that the reactivation of drug-associated memories and the 10 min-6 h of limited time window are two main elements in the R-E protocol. Virtual reality (VR) is supposed to promote memory reactivation by providing vivid drug-related stimuli when compared with movies.
Objective


The aim of this study is to examine the effectiveness of R-E training combined with VR on reducing spontaneous recovery or renewal of cue-elicited responses, in comparison to extinction, R-E training provided outside the time window of 6 h and R-E training retrieved using videos, in methamphetamine abusers.
Methods


The study is a parallel matched controlled study including 95 participants with MUD. Participants will be randomly assigned to either a R-10 min-E group (methamphetamine-related cues retrieval in VR followed by extinction after 10 min) or a NR-10 min-E group (neutral cues retrieval in VR followed by extinction after 10 min) or a R-6 h-E group (methamphetamine-related cues retrieval in VR followed by extinction after 6 h) or a RV-10 min-E group (methamphetamine-related cues retrieval in videos followed by extinction after 10 min). Cue-evoked craving and reactivity will be assessed at pre-test and at 1 day, 1 week, 1 month, and 6-month post-tests.
Discussion


To our knowledge, this study will probably be the first study to examine the efficacy of R-E training combined with VR to reduce cue-evoked responses in people with MUD. This innovative non-pharmacological intervention targeting drug-associated memories may provide significant clinical implications for reducing relapse, providing the study confirms its efficacy.
Clinical Trial Registration


The trial is registered with Chinese Clinical Trial Registry at 17 October 2018, number: ChiCTR1800018899, URL: http://www.chictr.org.cn/showproj.aspx?proj=30854.",2020,Participants will be randomly assigned to either a R-10 min-E group (methamphetamine-related cues retrieval in VR followed by extinction after 10 min) or a NR-10 min-E group (neutral cues retrieval in VR followed by extinction after 10 min) or a R-6 h-E group (methamphetamine-related cues retrieval in VR followed by extinction after 6 h) or a RV-10 min-E group (methamphetamine-related cues retrieval in videos followed by extinction after 10 min).,"['95 participants with MUD', 'methamphetamine abusers', 'people with MUD']","['R-E training combined with VR', 'R-10 min-E group (methamphetamine-related cues retrieval in VR followed by extinction after 10 min) or a NR-10 min-E group (neutral cues retrieval in VR followed by extinction after 10 min) or a R-6 h-E group (methamphetamine-related cues retrieval in VR followed by extinction after 6 h) or a RV-10 min-E group (methamphetamine-related cues retrieval in videos followed by extinction', 'Methamphetamine', 'Memory Retrieval-Extinction Combined With Virtual Reality', 'Extinction training', 'Virtual reality (VR']","['drug craving', 'Cue-evoked craving and reactivity']","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0556446', 'cui_str': 'Craves for drugs'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",95.0,0.0818371,Participants will be randomly assigned to either a R-10 min-E group (methamphetamine-related cues retrieval in VR followed by extinction after 10 min) or a NR-10 min-E group (neutral cues retrieval in VR followed by extinction after 10 min) or a R-6 h-E group (methamphetamine-related cues retrieval in VR followed by extinction after 6 h) or a RV-10 min-E group (methamphetamine-related cues retrieval in videos followed by extinction after 10 min).,"[{'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xi-Jing', 'Initials': 'XJ', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Ya-Tong', 'Initials': 'YT', 'LastName': 'Wen', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Markus H', 'Initials': 'MH', 'LastName': 'Winkler', 'Affiliation': 'Department of Psychology I, Biological Psychology, Clinical Psychology, and Psychotherapy, University of Wurzburg, Wurzburg, Germany.'}, {'ForeName': 'Pauli', 'Initials': 'P', 'LastName': 'Paul', 'Affiliation': 'Department of Psychology I, Biological Psychology, Clinical Psychology, and Psychotherapy, University of Wurzburg, Wurzburg, Germany.'}, {'ForeName': 'Yi-Ling', 'Initials': 'YL', 'LastName': 'He', 'Affiliation': ""Center for Mental Health, Women's Drug Rehabilitation Center of Guangdong Province, Foshan, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hong-Xian', 'Initials': 'HX', 'LastName': 'Chen', 'Affiliation': 'Mental Health Institute, Second Xiangya Hospital, Central South Universit\u2006y, Changsha, China.'}, {'ForeName': 'Yong-Hui', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00322']
1893,31285303,Cardiovascular safety of nintedanib in subgroups by cardiovascular risk at baseline in the TOMORROW and INPULSIS trials.,"Nintedanib is a tyrosine kinase inhibitor used to treat idiopathic pulmonary fibrosis (IPF). We investigated the cardiovascular safety of nintedanib using pooled data from the TOMORROW and INPULSIS trials.Cardiovascular events were assessed  post hoc  in patients with a history of atherosclerotic cardiovascular disease (CVD) and/or one or more cardiovascular risk factors at baseline (""higher cardiovascular risk"") and patients with no history of atherosclerotic CVD and no cardiovascular risk factors at baseline (""lower cardiovascular risk"").Incidence rates were calculated for 1231 patients (n=723 nintedanib and n=508 placebo), of whom 89.9% had higher cardiovascular risk. Incidence rates of major adverse cardiovascular events were similar in the nintedanib and placebo groups in patients with higher cardiovascular risk (3.88 (95% CI 2.58-5.84) and 3.49 (95% CI 2.10-5.79) per 100 patient-years, respectively) and lower cardiovascular risk (4.78 (95% CI 1.54-14.82) and 5.37 (95% CI 1.73-16.65) per 100 patient-years, respectively). Incidence rates of myocardial infarction in the nintedanib and placebo groups, respectively, were 3.03 (95% CI 1.91-4.81) and 1.16 (95% CI 0.48-2.79) per 100 patient-years in patients with higher cardiovascular risk and 1.59 (95% CI 0.22-11.29) and 1.78 (95% CI 0.25-12.64) per 100 patient-years in patients with lower cardiovascular risk. Incidence rates of other ischaemic heart disease in the nintedanib and placebo groups, respectively, were 1.85 (95% CI 1.02-3.34) and 3.28 (95% CI 1.94-5.54) per 100 patient-years in patients with higher cardiovascular risk and 0 and 1.80 (95% CI 0.25-12.78) per 100 patient-years in patients with lower cardiovascular risk.These data help to establish the cardiovascular safety profile of nintedanib in IPF.",2019,"Incidence rates of other ischaemic heart disease in the nintedanib and placebo groups, respectively, were 1.85 (95% CI:1.02-3.34) and 3.28 (95% CI:1.94-5.54) per 100 patient-years in patients with higher CV risk and 0 and 1.80 (95% CI:0.25-12.78) per 100 patient-years in patients with lower CV risk.",[],['placebo'],"['atherosclerotic CV disease (CVD) and/or ≥1 CV risk factor', 'CV safety', 'CV risk"").Incidence rates', 'CV risk', 'CV events', 'lower CV risk', 'Incidence rates of other ischaemic heart disease', 'atherosclerotic CVD and no CV risk factors', 'Incidence rates of myocardial infarction', 'Incidence rates of major adverse cardiovascular events', 'cardiovascular (CV) safety']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2609430', 'cui_str': 'Other ischaemic heart disease (SMQ)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.250991,"Incidence rates of other ischaemic heart disease in the nintedanib and placebo groups, respectively, were 1.85 (95% CI:1.02-3.34) and 3.28 (95% CI:1.94-5.54) per 100 patient-years in patients with higher CV risk and 0 and 1.80 (95% CI:0.25-12.78) per 100 patient-years in patients with lower CV risk.","[{'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Noth', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Virginia School of Medicine, Charlottesville, VA, USA IN2C@hscmail.mcc.virginia.edu.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Wijsenbeek', 'Affiliation': 'Dept of Pulmonary Medicine, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kolb', 'Affiliation': 'Dept of Respiratory Medicine, Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bonella', 'Affiliation': 'Interstitial and Rare Lung Disease Unit, Ruhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Lizette', 'Initials': 'L', 'LastName': 'Moros', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wachtlin', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Tamera J', 'Initials': 'TJ', 'LastName': 'Corte', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, Australia.'}]",The European respiratory journal,['10.1183/13993003.01797-2018']
1894,30723183,The effect of radiographic emphysema in assessing lung cancer risk.,"PURPOSE


Lung cancer risk models optimise screening by identifying subjects at highest risk, but none of them consider emphysema, a risk factor identifiable on baseline screen. Subjects with a negative baseline low-dose CT (LDCT) screen are at lower risk for subsequent diagnosis and may benefit from risk stratification prior to additional screening, thus we investigated the role of radiographic emphysema as an additional predictor of lung cancer diagnosis in participants with negative baseline LDCT screens of the National Lung Screening Trial.
METHODS


Our cohorts consist of participants with a negative baseline (T0) LDCT screen (n=16 624) and participants who subsequently had a negative 1-year follow-up (T1) screen (n=14 530). Lung cancer risk scores were calculated using the Bach, PLCOm2012 and Liverpool Lung Project models. Risk of incident lung cancer diagnosis at the end of the study and number screened per incident lung cancer were compared between participants with and without radiographic emphysema.
RESULTS


Radiographic emphysema was independently associated with nearly double the hazard of lung cancer diagnosis at both the second (T1) and third (T2) annual LDCT in all three risk models (HR range 1.9-2.0, p<0.001 for all comparisons). The number screened per incident lung cancer was considerably lower in participants with radiographic emphysema (62 vs 28 at T1 and 91 vs 40 at T2).
CONCLUSION


Radiographic emphysema is an independent predictor of lung cancer diagnosis and may help guide decisions surrounding further screening for eligible patients.",2019,"The number screened per incident lung cancer was considerably lower in participants with radiographic emphysema (62 vs 28 at T1 and 91 vs 40 at T2).
","['Subjects with a negative baseline low-dose', 'participants with and without radiographic emphysema', 'participants with a negative baseline (T0) LDCT screen (n=16\u2009624) and participants who subsequently had a negative 1-year follow-up (T1) screen (n=14\u2009530', 'participants with negative baseline LDCT screens of the National Lung Screening Trial']","['CT (LDCT) screen', 'radiographic emphysema']","['hazard of lung cancer diagnosis', 'Lung cancer risk scores', 'number screened per incident lung cancer', 'Radiographic emphysema', 'radiographic emphysema']","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}]","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}]",,0.0428519,"The number screened per incident lung cancer was considerably lower in participants with radiographic emphysema (62 vs 28 at T1 and 91 vs 40 at T2).
","[{'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Yong', 'Affiliation': 'General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Sigel', 'Affiliation': 'General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'de-Torres', 'Affiliation': 'Pulmonary Department, Clinica Universitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Mhango', 'Affiliation': 'General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Minal', 'Initials': 'M', 'LastName': 'Kale', 'Affiliation': 'General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Chung Yin', 'Initials': 'CY', 'LastName': 'Kong', 'Affiliation': 'Institute for Technology Assessment, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Javier J', 'Initials': 'JJ', 'LastName': 'Zulueta', 'Affiliation': 'Service of Pulmonary Medicine, Clinica Universitaria, Pamplona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'Medicine, Pulmonary Division, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Stacey-Ann Whittaker', 'Initials': 'SW', 'LastName': 'Brown', 'Affiliation': 'General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Slatore', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Health Care System, Portland, Oregon, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wisnivesky', 'Affiliation': 'General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}]",Thorax,['10.1136/thoraxjnl-2018-212457']
1895,32411045,Mindfulness Training for Improving Attention Regulation in University Students: Is It Effective? and Do Yoga and Homework Matter?,"The present study examined the effects of mindfulness training on attention regulation in university students and whether the potential benefits of implementation are influenced by the yoga component of mindfulness-based interventions (MBIs) and/or by MBI homework practice. In a non-randomized trial with pre- and post-assessments,  n  = 180 university students were allocated to either mindfulness training (experimental groups), awareness activities (active control group), or no training (passive control group). Mindfulness was taught through two MBIs, one including yoga and the other excluding yoga. Attention regulation was operationalized via behavioral indicators, namely sustained attention, cognitive flexibility, cognitive inhibition, and data-driven information processing. With the exception of speed in a cognitive flexibility task, the results indicated no systematic or differential advantage arising from mindfulness training, with or without yoga, regarding the aspects of attention regulation. There was no consistent influence of homework quantity or quality. The implications for mindfulness training in academic contexts are discussed.",2020,"With the exception of speed in a cognitive flexibility task, the results indicated no systematic or differential advantage arising from mindfulness training, with or without yoga, regarding the aspects of attention regulation.","['University Students', 'university students', 'n  = 180 university students']","['Mindfulness Training', 'mindfulness training (experimental groups), awareness activities (active control group), or no training (passive control group', 'mindfulness training']",['homework quantity or quality'],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0113017,"With the exception of speed in a cognitive flexibility task, the results indicated no systematic or differential advantage arising from mindfulness training, with or without yoga, regarding the aspects of attention regulation.","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Wimmer', 'Affiliation': 'Department of Psychology, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Silja', 'Initials': 'S', 'LastName': 'Bellingrath', 'Affiliation': 'Department of Psychology, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'von Stockhausen', 'Affiliation': 'Department of Psychology, University of Duisburg-Essen, Essen, Germany.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00719']
1896,32411054,Impact of Music on Working Memory in Rwanda.,"Previous research shows that listening to pleasant, stimulating and familiar music is likely to improve working memory performance. The benefits of music on cognition have been widely studied in Western populations, but not in other cultures. The purpose of this study was to explore the impact of music on working memory in a non-Western sociocultural context: Rwanda. One hundred and nineteen participants were randomly assigned to a control group (short story) or one of four different musical conditions varying on two dimensions: arousal (relaxing, stimulating) and cultural origin (Western, Rwandan). Working memory was measured using a behavioral task, the n-back paradigm, before and after listening to music (or the short story in the control condition). Unlike in previous studies with Western samples, our results with this Rwandan sample did not show any positive effect of familiar, pleasant and stimulating music on working memory. Performance on the n-back task generally improved from pre to post, in all conditions, but this improvement was less important in participants who listened to familiar Rwandan music compared to those who listened to unfamiliar Western music or to a short story. The study highlights the importance of considering the sociocultural context in research examining the impact of music on cognition. Although different aspects of music are considered universal, there may be cultural differences that limit the generalization of certain effects of music on cognition or that modulate the characteristics that favor its beneficial impact.",2020,"Performance on the n-back task generally improved from pre to post, in all conditions, but this improvement was less important in participants who listened to familiar Rwandan music compared to those who listened to unfamiliar Western music or to a short story.","['Rwanda', 'One hundred and nineteen participants']","['control group (short story) or one of four different musical conditions varying on two dimensions: arousal (relaxing, stimulating) and cultural origin (Western, Rwandan']","['positive effect of familiar, pleasant and stimulating music on working memory', 'working memory performance']","[{'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",119.0,0.131243,"Performance on the n-back task generally improved from pre to post, in all conditions, but this improvement was less important in participants who listened to familiar Rwandan music compared to those who listened to unfamiliar Western music or to a short story.","[{'ForeName': 'Sara-Valérie', 'Initials': 'SV', 'LastName': 'Giroux', 'Affiliation': 'Groupe de Recherche CogNAC, Département de Psychologie, Université du Québec à Trois-Rivières, Trois-Rivières, Québec, QC, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Caparos', 'Affiliation': 'DysCo Laboratory, Département de Psychologie, Université Paris 8, Saint-Denis, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Gosselin', 'Affiliation': 'Groupe de Recherche CogNAC, Département de Psychologie, Université du Québec à Trois-Rivières, Trois-Rivières, Québec, QC, Canada.'}, {'ForeName': 'Eugène', 'Initials': 'E', 'LastName': 'Rutembesa', 'Affiliation': 'College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Blanchette', 'Affiliation': 'Groupe de Recherche CogNAC, Département de Psychologie, Université du Québec à Trois-Rivières, Trois-Rivières, Québec, QC, Canada.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00774']
1897,32411082,Remote Ischemic Conditioning for Intracerebral Hemorrhage (RICH-1): Rationale and Study Protocol for a Pilot Open-Label Randomized Controlled Trial.,"Background and rationale:  Although many therapies have been investigated for intracerebral hemorrhage (ICH), none have succeeded in improving the functional outcomes. Remote ischemic conditioning (RIC) has been proven to promote hematoma resolution and improve neurological outcomes in an ICH model; whether it is safe and feasible in patients with ICH remains unknown. This trial aims to assess the safety, feasibility, and preliminary efficacy of RIC in patients with ICH and to plan for a phase-2 study.  Methods:  A proof-of-concept, assessor-blinded, pilot open-label randomized controlled trial will be carried out with patients with ICH within 24-48 h of ictus. All participants will be randomly allocated to the intervention group and the control group with a 1:1 ratio ( n  = 20) and will be treated with standard managements according to the guidelines. Participants allocated to the intervention group will receive RIC once daily for 7 consecutive days. Cranial computed tomography examinations will be performed at baseline, and on days 3, 7, and 14. Neurological outcomes will be assessed at baseline, and on days 1 to 14, 30, and 90. The primary outcome to be tested is safety. Secondary tested outcomes include changes of hematoma and perihematomal edema volume, incidence of hematoma expansion, functional outcomes, and frequency of adverse events.  Discussions:  This study will be the first proof-of-concept randomized controlled trial to ascertain the safety, feasibility, and preliminary efficacy of RIC in patients with ICH, results of which will provide parameters for future studies and provide insights into the treatment of ICH.  Trial Registration:  Clinicaltrials.gov, identifier: NCT03930940.",2020,"Secondary tested outcomes include changes of hematoma and perihematomal edema volume, incidence of hematoma expansion, functional outcomes, and frequency of adverse events.  ","['Intracerebral Hemorrhage (RICH-1', 'patients with ICH', 'patients with ICH and to plan for a phase-2 study', 'patients with ICH within 24-48 h of ictus']","['Remote ischemic conditioning (RIC', 'Remote Ischemic Conditioning', 'RIC']","['changes of hematoma and perihematomal edema volume, incidence of hematoma expansion, functional outcomes, and frequency of adverse events', 'Neurological outcomes']","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}]",,0.149228,"Secondary tested outcomes include changes of hematoma and perihematomal edema volume, incidence of hematoma expansion, functional outcomes, and frequency of adverse events.  ","[{'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Sijie', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Beijing Key Laboratory of Hypoxic Conditioning Translational Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chuanjie', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Gu', 'Affiliation': 'Department of Neurology, Ningjin County Hospital, Xingtai, China.'}, {'ForeName': 'Quanzhong', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, Heze Municipal Hospital, Heze, China.'}, {'ForeName': 'Xinjing', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Neurosurgery, The Sixth Hospital of Hengshui, Hengshui, China.'}, {'ForeName': 'Zongen', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Department of Neurology, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xunming', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Beijing Key Laboratory of Hypoxic Conditioning Translational Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Frontiers in neurology,['10.3389/fneur.2020.00313']
1898,31377075,"Randomized, single-blind, active-controlled phase I clinical trial to evaluate the immunogenicity and safety of GC3114 (high-dose, quadrivalent influenza vaccine) in healthy adults.","Influenza is a major medically attended respiratory illness. The impact of influenza on morbidity and mortality is particularly high in the elderly. Immunosenescence attenuates the immune response of influenza vaccine in the elderly. High-dose influenza vaccine contains 60 μg of hemagglutinin per strain, four times more compared with standard-dose (SD) influenza vaccine. This study is a phase I clinical trial investigating the immunogenicity and safety of the GC3114, high-dose, quadrivalent inactivated influenza vaccine (HD-QIV) in healthy adults aged 19-64 years during the 2017-2018 season. Seroprotection rates of HD-QIV were 100.0% for A/H1N1, 96.67% for A/H3N2, 83.33% for B/Yamagata, and 96.67% for B/Victoria. Seroconversion rate for A/H1N1, A/H3N2, B/Yamagata, and B/Victoria strains were 86.67%, 90.0%, 53.33%, and 53.33%, respectively, in the HD-QIV group. The post-/pre-vaccination geometric mean titer ratio (GMTR) was 15.28 for A/H1N1, 8.19 for A/H3N2, 3.56 for B/Yamagata, and 3.03 for B/Victoria in the HD-QIV group. Seroconversion rate and post-/pre-vaccination GMTR for A/H3N2 were significantly higher in the HD-QIV group than in the SD-QIV group (control). No serious adverse events were reported. In conclusion, GC3114 was safe, well-tolerated, and immunogenic in healthy adults. Clinical Trials Identifier: NCT03357263.",2019,Seroconversion rate and post-/pre-vaccination GMTR for A/H3N2 were significantly higher in the HD-QIV group than in the SD-QIV group (control).,"['healthy adults', 'healthy adults aged 19-64\u202fyears during the 2017-2018 season']","['GC3114', 'GC3114 (high-dose, quadrivalent influenza vaccine', 'GC3114, high-dose, quadrivalent inactivated influenza vaccine (HD-QIV', 'Immunosenescence']","['Seroprotection rates of HD-QIV', 'post-/pre-vaccination geometric mean titer ratio (GMTR', 'Seroconversion rate', 'morbidity and mortality', 'serious adverse events', 'Seroconversion rate and post-/pre-vaccination GMTR']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0596761', 'cui_str': 'Immunosenescence'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2018.0,0.0590526,Seroconversion rate and post-/pre-vaccination GMTR for A/H3N2 were significantly higher in the HD-QIV group than in the SD-QIV group (control).,"[{'ForeName': 'Ji Yun', 'Initials': 'JY', 'LastName': 'Noh', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Asia Pacific Influenza Institute, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ye Seul', 'Initials': 'YS', 'LastName': 'Jang', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Saem Na', 'Initials': 'SN', 'LastName': 'Lee', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Min Joo', 'Initials': 'MJ', 'LastName': 'Choi', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Asia Pacific Influenza Institute, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Gu', 'Initials': 'JG', 'LastName': 'Yoon', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Du Hyeon', 'Initials': 'DH', 'LastName': 'Yu', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Joon Young', 'Initials': 'JY', 'LastName': 'Song', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Asia Pacific Influenza Institute, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Jin', 'Initials': 'HJ', 'LastName': 'Cheong', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Asia Pacific Influenza Institute, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Woo Joo', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Asia Pacific Influenza Institute, Korea University College of Medicine, Seoul, Republic of Korea. Electronic address: wjkim@korea.ac.kr.'}]",Vaccine,['10.1016/j.vaccine.2019.07.076']
1899,32411031,Effect of Electroacupuncture and Counseling on Sub-Threshold Depression: A Study Protocol for a Multicenter Randomized Controlled Trial.,"Background


Sub-threshold depression is common and could impair function, as well as increase the risk of developing major depression. Despite evidence of efficacy for electroacupuncture (EA) and counseling in the treatment of sub-threshold depression, the sample size is insufficient and the level of evidence remains low. This study aims to evaluate the effectiveness of sub-threshold depression treatments by comparing the treatment effects among EA, counseling, and combination therapy, as well as to further study their mechanism.
Methods


This study is a multicenter, randomized, single blind clinical trial that will be conducted in settings at four clinical centers in China. The randomized controlled trial (RCT) will examine the effectiveness of EA intervention, compared with counseling and combination therapy. A total of 138 sub-threshold depression patients (18 to 55 years of age with Beck Depression Inventory (BDI-II) score ≥ 14 points and Hamilton Depression Scale (HAMD-17) score: 7 points ≤ HAMD total score <17 points) will be recruited. The participants will be randomly assigned to receive the above treatments. The interventions will be delivered over a 6-week period (EA: 3 times a week for 6 weeks; 30 min a session. Counseling: once a week for 6 weeks; 50-60 min a session). The primary outcome measure will be the HAMD-17; BDI-II. The secondary outcome measures will be: Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI). The assessments will occur at baseline, 2, 4, and 6 weeks and a follow-up period. Recruitment will commence in March 2020 and is anticipated to occur over a 2-year period.
Discussion


This study intends to conduct a multicenter randomized controlled trial to compare the effectiveness among EA, counseling and the combined therapy in the treatment of patients with sub-threshold depression, and to further study the mechanisms of effect.
Chinese Clinical Trial Registry registration


www.chictr.org.cn/, identifier ChiCTR1900028530.",2020,"The secondary outcome measures will be: Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI).","['settings at four clinical centers in China', 'patients with sub-threshold depression', 'A total of 138 sub-threshold depression patients (18 to 55 years of age with Beck Depression Inventory (BDI-II) score ≥ 14 points and Hamilton Depression Scale (HAMD-17) score: 7 points ≤ HAMD total score <17 points) will be recruited']","['electroacupuncture (EA', 'Electroacupuncture and Counseling', 'EA intervention']","['HAMD-17; BDI-II', 'Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI', 'Sub-Threshold Depression']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.214497,"The secondary outcome measures will be: Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI).","[{'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'South China Research Center for Acupuncture and Moxibustion, Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Haixiong', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'The First School of Clinical Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xiumin', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'South China Research Center for Acupuncture and Moxibustion, Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Student Mental Health Counseling Center, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'Student Mental Health Counseling Center, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': 'South China Research Center for Acupuncture and Moxibustion, Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'South China Research Center for Acupuncture and Moxibustion, Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Shengwei', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Traditional Chinese Medicine, Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Traditional Chinese Medicine, Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Danian', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Rehabilitation Center, Counseling Department, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'South China Research Center for Acupuncture and Moxibustion, Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'South China Research Center for Acupuncture and Moxibustion, Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00346']
1900,31355924,Follow-up approaches to a health literacy intervention to increase colorectal cancer screening in rural community clinics: A randomized controlled trial.,"BACKGROUND


Significant disparities exist in colorectal cancer (CRC) screening rates among those of low socioeconomic status, with fewer years of education, lacking health insurance, or living in rural areas.
METHODS


A randomized controlled trial was conducted to compare the effectiveness of 2 follow-up approaches to a health literacy intervention to improve CRC screening: automated telephone call or personal call. Patients aged 50 to 75 years residing in 4 rural community clinics in Louisiana were given a structured interview that assessed demographic, health literacy and CRC screening barriers, knowledge, and attitudes. All were given health literacy-informed CRC education, a patient-friendly CRC screening pamphlet, simplified fecal immunochemical test (FIT) instructions, and a FIT kit, and a ""teach-back"" method was used to confirm understanding. Patients were randomized to 1 of 2 telephone follow-up arms. If they did not mail their FIT kit within 4 weeks, they received a reminder call and were called again at 8 weeks if the test still was not received.
RESULTS


A total of 620 patients were enrolled. Approximately 55% were female, 66% were African American, and 40% had limited literacy. The overall FIT completion rate was 68%: 69.2% in the automated telephone call arm and 67% in the personal call arm. Greater than one-half of the patients (range, 58%-60%) returned the FIT kit without receiving a telephone call. There was no difference noted with regard to the effectiveness of the follow-up calls; each increased the return rate by 9%.
CONCLUSIONS


Providing FIT kits and literacy-appropriate education at regularly scheduled clinic visits with a follow-up telephone call when needed was found to increase CRC screening among low-income, rural patients. The lower cost automated call was just as effective as the personal call.",2019,"There was no difference noted with regard to the effectiveness of the follow-up calls; each increased the return rate by 9%.
","['colorectal cancer (CRC) screening rates among those of low socioeconomic status, with fewer years of education, lacking health insurance, or living in rural areas', 'rural community clinics', 'Approximately 55% were female, 66% were African American, and 40% had limited literacy', 'Patients aged 50 to 75\xa0years residing in 4 rural community clinics in Louisiana were given a structured interview that assessed demographic, health literacy and CRC screening barriers, knowledge, and attitudes', '620 patients were enrolled']","['telephone call or personal call', 'health literacy intervention']","['return rate', 'overall FIT completion rate', 'colorectal cancer screening']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4708788', 'cui_str': '620'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",620.0,0.0966608,"There was no difference noted with regard to the effectiveness of the follow-up calls; each increased the return rate by 9%.
","[{'ForeName': 'Connie L', 'Initials': 'CL', 'LastName': 'Arnold', 'Affiliation': 'Department of Medicine, Louisiana State University Health Sciences Center-Shreveport, Shreveport, Louisiana.'}, {'ForeName': 'Alfred W', 'Initials': 'AW', 'LastName': 'Rademaker', 'Affiliation': 'Department of Preventive Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, Louisiana State University Health Sciences Center-Shreveport, Shreveport, Louisiana.'}, {'ForeName': 'Laurie Anne', 'Initials': 'LA', 'LastName': 'Ferguson', 'Affiliation': 'College of Nursing and Health, Loyola University New Orleans, New Orleans, Louisiana.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wiltz', 'Affiliation': 'Teche Action Clinic, Franklin, Louisiana.'}, {'ForeName': 'Terry C', 'Initials': 'TC', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Louisiana State University Health Sciences Center-Shreveport, Shreveport, Louisiana.'}]",Cancer,['10.1002/cncr.32398']
1901,32411212,Efficacy of Tamsulosin plus Tadalafil versus Tamsulosin as Medical Expulsive Therapy for Lower Ureteric Stones: A Randomized Controlled Trial.,"Introduction


Urolithiasis is one of the common disorder with which about 1/5 th  is found in the ureter, of which 2/3 rd  is seen in the lower ureter. Medical expulsive therapy is one of the routine modalities of treatment which uses various drugs acting on the ureter smooth muscle by different mechanism. We aim to compare the efficacy of combination vs. single drug.
Methods


This randomized controlled trial was done in 176 consecutive patients over a period of six months (March 2019 to August 2019) in Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching. Participants were divided into two groups (Group A, tamsulosin plus tadalafil, and Group B, tamsulosin) from computer-generated random numbers. Therapy was continued for a maximum of 3 weeks. Stone expulsion rate, time to stone expulsion, analgesic use, number of colic and emergency room visits for pain, early intervention, and adverse effects of drugs were recorded.
Results


Among 176 patients who were enrolled in study, 7 were lost to follow-up, and 5 people required immediate intervention. There was a significant higher stone passage rate in group A than group B (64 vs. 50;  P =0.025) and shorter expulsion time (1.66 vs. 2.32 weeks  P =0.001) and less number of emergency room visits and colic episodes. No significant side effects were noted during study.
Conclusion


Tamsulosin plus Tadalafil is more effective than tamsulosin with early passage of stone and decreased number of colic episodes and emergency visits without significant side effects for lower ureteric calculi of 5 mm to 10 mm.",2020,There was a significant higher stone passage rate in group A than group B (64 vs. 50;  P =0.025) and shorter expulsion time (1.66 vs. 2.32 weeks  P =0.001) and less number of emergency room visits and colic episodes.,"['176 consecutive patients over a period of six months (March 2019 to August 2019) in Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching', '176 patients who were enrolled in study, 7 were lost to follow-up, and 5 people required immediate intervention', 'Lower Ureteric Stones']","['tamsulosin', 'Tamsulosin', 'combination vs. single drug', 'tamsulosin plus tadalafil, and Group B, tamsulosin', 'Tamsulosin plus Tadalafil']","['shorter expulsion time', 'stone passage rate', 'number of emergency room visits and colic episodes', 'Stone expulsion rate, time to stone expulsion, analgesic use, number of colic and emergency room visits for pain, early intervention, and adverse effects of drugs', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0303134', 'cui_str': 'Beryllium-7'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0232488', 'cui_str': 'Abdominal colic'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",176.0,0.0783319,There was a significant higher stone passage rate in group A than group B (64 vs. 50;  P =0.025) and shorter expulsion time (1.66 vs. 2.32 weeks  P =0.001) and less number of emergency room visits and colic episodes.,"[{'ForeName': 'Diwas', 'Initials': 'D', 'LastName': 'Gnyawali', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Manish Man', 'Initials': 'MM', 'LastName': 'Pradhan', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Prem Raj', 'Initials': 'PR', 'LastName': 'Sigdel', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Purushottam', 'Initials': 'P', 'LastName': 'Parajuli', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Sampanna', 'Initials': 'S', 'LastName': 'Chudal', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Sujeet', 'Initials': 'S', 'LastName': 'Poudyal', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Chapagain', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Bhoj Raj', 'Initials': 'BR', 'LastName': 'Luitel', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Pawan Raj', 'Initials': 'PR', 'LastName': 'Chalise', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Uttam', 'Initials': 'U', 'LastName': 'Sharma', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}, {'ForeName': 'Prem Raj', 'Initials': 'PR', 'LastName': 'Gyawali', 'Affiliation': 'Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgung, Kathmandu 44600, Nepal.'}]",Advances in urology,['10.1155/2020/4347598']
1902,32411217,Balance as an Additional Effect of Strength and Flexibility Aquatic Training in Sedentary Lifestyle Elderly Women.,"Objective


To evaluate the additional effects of on balance an aquatic muscle strengthening and flexibility training program in healthy sedentary lifestyle elderly women.
Method


This controlled clinical trial included 56 healthy sedentary women, aged from 65 to 70 years, divided into two groups. The aquatic group (AG) underwent aquatic training (45 minutes/session, 32 sessions), and the control group (CG) received no intervention. Data were collected pre- and post-intervention, during a one-week period. Lower limb muscle strength was measured by a force sensor (myometer). Flexibility was measured by biophotogrammetry. Functional balance was evaluated by the Performance Oriented Mobility Assessment (POMA) and the Berg Balance Scale (BBS).
Results


Muscle strength, flexibility, and balance improved in AG ( p  < 0.001), but not in CG.
Conclusion


The aquatic exercises program, which was originally developed to promote muscle strength and flexibility, also improved functional balance. Aquatic training is an option for physical health promotion for sedentary lifestyle elderly women.",2020,"Results


Muscle strength, flexibility, and balance improved in AG ( p  < 0.001), but not in CG.
","['Sedentary Lifestyle Elderly Women', 'sedentary lifestyle elderly women', 'healthy sedentary lifestyle elderly women', '56 healthy sedentary women, aged from 65 to 70 years, divided into two groups']","['Aquatic training', 'Strength and Flexibility Aquatic Training', 'control group (CG) received no intervention', 'aquatic training', 'aquatic muscle strengthening and flexibility training program']","['Muscle strength, flexibility, and balance improved in AG', 'Performance Oriented Mobility Assessment (POMA) and the Berg Balance Scale (BBS', 'Lower limb muscle strength', 'Flexibility', 'Functional balance']","[{'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2317515', 'cui_str': 'Assessment of mobility'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",56.0,0.010815,"Results


Muscle strength, flexibility, and balance improved in AG ( p  < 0.001), but not in CG.
","[{'ForeName': 'Fernando Alves', 'Initials': 'FA', 'LastName': 'Vale', 'Affiliation': 'PT, MSc. Rehabilitation Sciences Post Graduation Program of Medical School of University of São Paulo, Laboratory of Physical Therapy and Behavior, São Paulo, Brazil.'}, {'ForeName': 'Mariana Callil', 'Initials': 'MC', 'LastName': 'Voos', 'Affiliation': 'Professor at Ibirapuera University, Physical Therapy Course, São Paulo, Brazil.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Brumini', 'Affiliation': 'Professor at Ibirapuera University, Physical Therapy Course, São Paulo, Brazil.'}, {'ForeName': 'Eneida Yuri', 'Initials': 'EY', 'LastName': 'Suda', 'Affiliation': 'Professor at Ibirapuera University, Physical Therapy Course, São Paulo, Brazil.'}, {'ForeName': 'Ronaldo Luis', 'Initials': 'RL', 'LastName': 'da Silva', 'Affiliation': 'PT, MSc. Faculté des Sciences, Université du Québec à Montréal, Quebec, Canada.'}, {'ForeName': 'Fátima Aparecida', 'Initials': 'FA', 'LastName': 'Caromano', 'Affiliation': 'PT, PhD. Rehabilitation Sciences Post Graduation Program of Medical School of University of São Paulo, Laboratory of Physical Therapy and Behavior, São Paulo, Brazil.'}]",Current gerontology and geriatrics research,['10.1155/2020/1895473']
1903,31537697,Sequential screening for lung cancer in a high-risk group: randomised controlled trial: LungSEARCH: a randomised controlled trial of Surveillance using sputum and imaging for the EARly detection of lung Cancer in a High-risk group.,"BACKGROUND


Low-dose computed tomography (LDCT) screening detects early-stage lung cancer and reduces mortality. We proposed a sequential approach targeted to a high-risk group as a potentially efficient screening strategy.
METHODS


LungSEARCH was a national multicentre randomised trial. Current/ex-smokers with mild/moderate chronic obstructive pulmonary disease (COPD) were allocated (1:1) to have 5 years surveillance or not. Screened participants provided annual sputum samples for cytology and cytometry, and if abnormal were offered annual LDCT and autofluorescence bronchoscopy (AFB). Those with normal sputum provided annual samples. The primary end-point was the percentage of lung cancers diagnosed at stage I/II (nonsmall cell) or limited disease (small cell).
RESULTS


1568 participants were randomised during 2007-2011 from 10 UK centres. 85.2% of those screened provided an adequate baseline sputum sample. There were 42 lung cancers among 785 screened individuals and 36 lung cancers among 783 controls. 54.8% (23 out of 42) of screened individuals  versus  45.2% (14 out of 31) of controls with known staging were diagnosed with early-stage disease (one-sided p=0.24). Relative risk was 1.21 (95% CI 0.75-1.95) or 0.82 (95% CI 0.52-1.31) for early-stage or advanced cancers, respectively. Overall sensitivity for sputum (in those randomised to surveillance) was low (40.5%) with a cumulative false-positive rate (FPR) of 32.8%. 55% of cancers had normal sputum results throughout. Among sputum-positive individuals who had AFB, sensitivity was 45.5% and cumulative FPR was 39.5%; the corresponding measures for those who had LDCT were 100% and 16.1%, respectively.
CONCLUSIONS


Our sequential strategy, using sputum cytology/cytometry to select high-risk individuals for AFB and LDCT, did not lead to a clear stage shift and did not improve the efficiency of lung cancer screening.",2019,Overall sensitivity for sputum (in those randomised to surveillance) was low (40.5%) and cumulative false-positive rate (FPR) 32.8%.,"['Current/former smokers with mild/moderate COPD', '1568 individuals were randomised 2007-2011, from 10 UK centres', '42 lung cancers among 785 screened and 36 among 783 controls']","['Sequential screening', 'Low-dose CT (LDCT) screening']","['percentage of lung cancers diagnosed at stage I/II (non-small cell) or limited disease (small cell', 'Overall sensitivity for sputum', 'cumulative false-positive rate']","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0445128', 'cui_str': 'Non-small cell (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0205557', 'cui_str': 'False positive (qualifier value)'}]",1568.0,0.472867,Overall sensitivity for sputum (in those randomised to surveillance) was low (40.5%) and cumulative false-positive rate (FPR) 32.8%.,"[{'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Spiro', 'Affiliation': 'Dept of Respiratory Medicine, University College Hospital, London, UK.'}, {'ForeName': 'Pallav L', 'Initials': 'PL', 'LastName': 'Shah', 'Affiliation': 'Dept of Respiratory Medicine, Royal Brompton Hospital, Chelsea and Westminster Hospital and Imperial College London, London, UK.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Rintoul', 'Affiliation': 'Dept of Oncology, Royal Papworth Hospital and University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'UCL Respiratory, Dept of Medicine, University College London, London, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Janes', 'Affiliation': 'UCL Respiratory, Dept of Medicine, University College London, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Callister', 'Affiliation': 'Dept of Respiratory Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Novelli', 'Affiliation': 'Cellular Pathology, University College Hospital, London, UK.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Shaw', 'Affiliation': 'Radiology (Imaging), University College Hospital, London, UK.'}, {'ForeName': 'Gabrijela', 'Initials': 'G', 'LastName': 'Kocjan', 'Affiliation': 'Cellular Pathology, University College Hospital, London, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Griffiths', 'Affiliation': 'Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Falzon', 'Affiliation': 'Cellular Pathology, University College Hospital, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Booton', 'Affiliation': 'Lung Cancer and Thoracic Surgery Directorate, Manchester University NHS Trust and University of Manchester, Manchester, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Magee', 'Affiliation': 'Respiratory Medicine, Belfast City Hospital, Belfast, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Peake', 'Affiliation': 'Dept of Immunity, Infection and Inflammation, University of Leicester, Leicester, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dhillon', 'Affiliation': 'Respiratory Medicine, University Hospitals Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'Kishore', 'Initials': 'K', 'LastName': 'Sridharan', 'Affiliation': 'Dept of Thoracic Medicine, Sunderland Royal Hospital, Sunderland, UK.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Nicholson', 'Affiliation': 'Dept of Histopathology, Royal Brompton Hospital and Harefield NHS Foundation Trust and National Heart and Lung Institute, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Padley', 'Affiliation': 'Radiology, Royal Brompton Hospital and National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Magali N', 'Initials': 'MN', 'LastName': 'Taylor', 'Affiliation': 'Radiology (Imaging), University College Hospital, London, UK.'}, {'ForeName': 'Asia', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Radiology (Imaging), University College Hospital, London, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, London, UK.'}, {'ForeName': 'Yenting', 'Initials': 'Y', 'LastName': 'Ngai', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, London, UK.'}, {'ForeName': 'Nyasha', 'Initials': 'N', 'LastName': 'Chinyanganya', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ashford-Turner', 'Affiliation': 'Cardio-Respiratory Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Research and Development, Royal Papworth Hospital, Cambridge, UK.'}, {'ForeName': 'Dahmane', 'Initials': 'D', 'LastName': 'Oukrif', 'Affiliation': 'Dept of Pathology, University College Hospital, London, UK.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rabbitts', 'Affiliation': 'Leeds Institute of Cancer and Pathology (LICAP), University of Leeds, Leeds, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Counsell', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, London, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, London, UK.'}]",The European respiratory journal,['10.1183/13993003.00581-2019']
1904,31450541,Assessment of radiation dose and iodine load reduction in head-neck CT angiography using two scan protocols with wide-detector.,"OBJECTIVE


To compare image quality, radiation dose, and iodine intake of head-neck CT angiography (CTA) acquired by wide-detector with the gemstone spectral imaging (GSI) combination with low iodine intake or routine scan protocol.
METHODS


Three hundred patients who had head-neck CTA were enrolled and divided into three groups according to their BMI values: group A (18.5 kg/m2 ≦ BMI <24.9 kg/m2), group B (24.9 kg/m2 ≦ BMI <29.9 kg/m2) and group C (29.9 kg/m2 ≦ BMI ≦ 34.9 kg/m2) with 100 patients in each group. Patients in each group were randomly divided into two subgroups (n = 50) namely, A1, A2, B1, B2, C1 and C2. The patients in subgroups A1, B1 and C1 underwent GSI with low iodine intake (270 mgI/ml, 50 ml) and combined with the ASiR-V algorithm. Other patients underwent three dimensional (3D) smart mA modulation with routine iodine intake (350 mgI/ml, 60 ml). Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of all images were calculated after angiography. Images were then subjectively assessed using a 5-point scale. CT dose index of volume and dose-length product (DLP) was converted to the effective dose (ED) and then compared.
RESULTS


The mean CT values, SNR, CNR and subjective image quality in subgroups A2, B2 and C2 are significantly lower than in subgroups A1, B1, and C1 (P < 0.01), respectively. The ED values in subgroup A1, B1, and C1 are 55.18%, 61.89%, and 69.64% lower than those in A2, B2, and C2, respectively (P < 0.01). The total iodine intakes in subgroups A1, B1, and C1 are 35.72% lower than those in subgroups A2, B2, and C2.
CONCLUSIONS


The gemstone spectral imaging with monochromatic images at 53-57 keV combined with ASiR-V algorithm allows significant reduction in iodine load and radiation dose in head-neck CT angiography than those yielded in routine scan protocol. It also enhances signal intensity of head-neck CTA and maintains image quality.",2019,"The mean CT values, SNR, CNR and subjective image quality in subgroups A2, B2 and C2 are significantly lower than in subgroups A1, B1, and C1 (P < 0.01), respectively.",['Three hundred patients who had head-neck CTA'],"['GSI with low iodine intake', 'iodine intake of head-neck CT angiography (CTA) acquired by wide-detector with the gemstone spectral imaging (GSI) combination with low iodine intake', 'three dimensional (3D) smart mA modulation with routine iodine intake']","['total iodine intakes', 'CT dose index of volume and dose-length product (DLP', 'mean CT values, SNR, CNR and subjective image quality', 'Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",300.0,0.0175663,"The mean CT values, SNR, CNR and subjective image quality in subgroups A2, B2 and C2 are significantly lower than in subgroups A1, B1, and C1 (P < 0.01), respectively.","[{'ForeName': 'Yongxia', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Hebei University, Baoding, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Geng', 'Affiliation': 'College of Medicine, Hebei University, Baoding, China.'}, {'ForeName': 'Tianle', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'College of Medicine, Hebei University, Baoding, China.'}, {'ForeName': 'Xiuzhi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'College of Medicine, Hebei University, Baoding, China.'}, {'ForeName': 'Yize', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'College of Medicine, Hebei University, Baoding, China.'}, {'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Dong', 'Affiliation': 'College of Medicine, Hebei University, Baoding, China.'}]",Journal of X-ray science and technology,['10.3233/XST-190541']
1905,29113521,Efficacy and safety of vortioxetine for the treatment of major depressive disorder: a randomised double-blind placebo-controlled study.,"Objective:  This study aimed to evaluate the efficacy and adverse events of vortioxetine for Chinese patients with major depressive disorder (MDD) over 10 weeks. Methods:  A total of 120 patients with MDD were randomly assigned to two groups that received vortioxetine 20 mg or placebo for 10 weeks. The outcomes were the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impressions-Improvement (CGI-I) scale, Sheehan Disability Scale (SDS) at Week 10, and the presence of adverse events. Results:  A total of 113 patients completed the study. Vortioxetine showed greater efficacy than the placebo in improving MADRS, HAM-A, CGI-I, and SDS scores at Week 10. However, no significant differences were found between the groups for any treatment-emergent adverse events. No suicide related to vortioxetine treatment was recorded. Conclusions:  In summary, the results of this study showed that 10 weeks of vortioxetine treatment was efficacious and well-tolerated in patients with MDD.",2019,"Vortioxetine showed greater efficacy than the placebo in improving MADRS, HAM-A, CGI-I, and SDS scores at Week 10.","['120 patients with MDD', '113 patients completed the study', 'major depressive disorder', 'Chinese patients with major depressive disorder (MDD) over 10\xa0weeks', 'patients with MDD']","['vortioxetine', 'vortioxetine 20\u2009mg or placebo', 'placebo', 'Vortioxetine']","['efficacious and well-tolerated', 'Efficacy and safety', 'Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impressions-Improvement (CGI-I) scale, Sheehan Disability Scale (SDS', 'MADRS, HAM-A, CGI-I, and SDS scores']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C3692166', 'cui_str': 'vortioxetine 20 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",120.0,0.153497,"Vortioxetine showed greater efficacy than the placebo in improving MADRS, HAM-A, CGI-I, and SDS scores at Week 10.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Diagnosis, The Affiliated Hongqi Hospital of Mudanjiang Medical University, Mudanjiang, China.'}, {'ForeName': 'Xi-Fang', 'Initials': 'XF', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Diagnosis, The Affiliated Hongqi Hospital of Mudanjiang Medical University, Mudanjiang, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Department of Ultrasound, The Affiliated Hongqi Hospital of Mudanjiang Medical University, Mudanjiang, China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Bao', 'Affiliation': 'Department of Nuclear Magnetic Resonance, The Affiliated Hongqi Hospital of Mudanjiang Medical University, Mudanjiang, China.'}, {'ForeName': 'Hong-Ran', 'Initials': 'HR', 'LastName': 'Fu', 'Affiliation': 'Department of Clinical Laboratory, The Affiliated Hongqi Hospital of Mudanjiang Medical University, Mudanjiang, China.'}]",International journal of psychiatry in clinical practice,['10.1080/13651501.2017.1397700']
1906,31557763,Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial.,"Importance


The role of aspirin as part of antiplatelet regimens in acute coronary syndromes (ACS) needs to be clarified in the context of newer potent P2Y12 antagonists.
Objective


To evaluate the benefit and risks of aspirin in addition to ticagrelor among patients with ACS beyond 1 month after percutaneous coronary intervention (PCI).
Design, Setting, and Participants


This is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI. The trial included 130 secondary/tertiary care hospitals in different countries, with 15 991 unselected patients with stable coronary artery disease or ACS undergoing PCI. Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure.
Interventions


The experimental group received aspirin plus ticagrelor for 1 month followed by 23-month ticagrelor monotherapy; the reference group received aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS) for 12 months, followed by 12-month aspirin monotherapy. In this analysis, we examined the clinical outcomes occurring between 31 days and 365 days after randomization, specifically in patients with ACS who, within this time frame, were assigned to receive either ticagrelor alone or ticagrelor and aspirin.
Main Outcomes and Measures


The primary outcome was the composite of all-cause death or new Q-wave myocardial infarction.
Results


Of 15 968 participants, there were 7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group. Between 31 and 365 days after randomization, the primary outcome occurred in 55 patients (1.5%) in the experimental group and in 75 patients (2.0%) in the reference group (hazard ratio [HR], 0.73; 95% CI, 0.51-1.03; P = .07); investigator-reported Bleeding Academic Research Consortium-defined bleeding type 3 or 5 occurred in 28 patients (0.8%) in the experimental group and in 54 patients (1.5%) in the reference arm (HR, 0.52; 95% CI, 0.33-0.81; P = .004).
Conclusions and Relevance


Between 1 month and 12 months after PCI in ACS, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. These findings should be interpreted as exploratory and hypothesis generating; however, they pave the way for further trials evaluating aspirin-free antiplatelet strategies after PCI.
Trial Registration


ClinicalTrials.gov identifier: NCT01813435.",2019,"This is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI.","['acute coronary syndromes (ACS', '968 participants', 'patients with ACS who, within this time frame', 'Acute Coronary Syndromes', 'Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure', '7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group', '130 secondary/tertiary care hospitals in different countries, with 15\u202f991 unselected patients with stable coronary artery disease or ACS undergoing PCI', 'patients with ACS beyond 1 month after percutaneous coronary intervention (PCI']","['Aspirin', 'Ticagrelor', 'ticagrelor alone or ticagrelor and aspirin', 'aspirin plus ticagrelor', 'aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS', 'aspirin', 'ticagrelor', 'aspirin monotherapy']","['composite of all-cause death or new Q-wave myocardial infarction', 'bleeding risk']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C4517746', 'cui_str': '3750'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",130.0,0.0780479,"This is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI.","[{'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Efthymios N', 'Initials': 'EN', 'LastName': 'Deliargyris', 'Affiliation': 'PLx Pharma Inc, Sparta, New Jersey.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Chun Ching', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiology, Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Rademaker-Havinga', 'Affiliation': 'Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, England.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital Heart and Vascular Center, Boston, Massachusetts.""}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida, College of Medicine, Jacksonville.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'University of Giessen, Giessen, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'French Alliance for Cardiovascular Trials, Université Paris Diderot, Hôpital Bichat, Assistance Publique Hôpitaux de Paris, and INSERM U-1148, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, England.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2019.3355']
1907,31246283,Nivolumab treatment beyond RECIST-defined progression in recurrent or metastatic squamous cell carcinoma of the head and neck in CheckMate 141: A subgroup analysis of a randomized phase 3 clinical trial.,"BACKGROUND


Response patterns with immune checkpoint inhibitors may be different from those with chemotherapy. Therefore, assessment of response to immunotherapy with the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, could result in premature treatment termination. The randomized, open-label, phase 3 CheckMate 141 trial (NCT02105636), which evaluated nivolumab in recurrent/metastatic squamous cell carcinoma of the head and neck after platinum therapy, allowed treatment beyond first RECIST-defined progression (TBP) according to protocol-specified criteria.
METHODS


In CheckMate 141, patients with RECIST-defined progression who had a stable performance status and demonstrated clinical benefit without rapid disease progression were permitted to receive TBP with nivolumab at 3 mg/kg every 2 weeks until further progression, which was defined as an additional ≥10% increase in tumor volume. This post hoc analysis evaluated outcomes for patients who received TBP with nivolumab.
RESULTS


Of 240 patients randomized to nivolumab, 146 experienced RECIST-defined progression. Sixty-two of these patients received TBP, and 84 discontinued treatment (no TBP). Among the 60 TBP patients evaluable for response, 15 (25%) had no change in their tumor burden, and 15 (25%) had reductions in target lesion size; 3 patients (5%) had reductions >30%. The median overall survival among TBP patients was 12.7 months (95% confidence interval, 9.7-14.6 months). No new safety signals were observed with TBP. Exploratory analyses of immune cell biomarkers suggested a potential relationship with initial and TBP responses.
CONCLUSIONS


Tumor burden reduction was noted in a proportion of patients who received TBP with nivolumab in CheckMate 141. Additional research is warranted to identify factors predictive of a TBP benefit in this population.",2019,No new safety signals were observed with TBP.,"['recurrent/metastatic squamous cell carcinoma of the head and neck after platinum therapy, allowed treatment beyond first RECIST-defined progression (TBP) according to protocol-specified criteria', '240 patients randomized to nivolumab, 146 experienced RECIST-defined progression', 'patients who received TBP with nivolumab', 'recurrent or metastatic squamous cell carcinoma of the head and neck in CheckMate 141']","['Nivolumab treatment beyond RECIST', 'TBP']",['median overall survival'],"[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0077021', 'cui_str': 'tributyl phosphate'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0077021', 'cui_str': 'tributyl phosphate'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",240.0,0.187629,No new safety signals were observed with TBP.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': 'Dana-Farber/Harvard Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Concha-Benavente', 'Affiliation': 'Hillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blumenschein', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Fayette', 'Affiliation': 'Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Guigay', 'Affiliation': ""Centre Antoine Lacassagne, FHU OncoAge, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'A Dimitrios', 'Initials': 'AD', 'LastName': 'Colevas', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kasper', 'Affiliation': 'West German Cancer Center, University Hospital, Essen, Germany.'}, {'ForeName': 'Everett E', 'Initials': 'EE', 'LastName': 'Vokes', 'Affiliation': 'University of Chicago Medical Center, Chicago, Illinois.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Worden', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Vijayvel', 'Initials': 'V', 'LastName': 'Jayaprakash', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lynch', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Gillison', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Harrington', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Royal Marsden/Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'Hillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}]",Cancer,['10.1002/cncr.32190']
1908,32411039,The Effect of an Enriched Sport Program on Children's Executive Functions: The ESA Program.,"Purpose


The effects of physical exercise on executive functions (EFs) are well-documented. EFs are involved in daily activities, and their development determines the quality of people's future life, both in terms of mental health and quality of life. The purpose of the current paper is to evaluate the effects of a physical education program, elaborated within the Enriched Sports Activity Program (ESA Program), an Erasmus + Project, on EFs, namely, visuospatial working memory, inhibitory control, cognitive flexibility, and task switching.
Method


Data were collected on November 2017 (t 1 ) and May 2018 (t 2 ). At t 1 , a sample of 357 children from four European countries (Italy, Germany, Lithuania, and Turkey) performed a cognitive test battery made up of Digit Span Forward/Backward, Stroop Task, and Trail Making Test (TMT), whose order was randomized. From November until May, classrooms from the experimental group followed the ESA Program, while classrooms from the control continued with the ordinary physical education class. At t 2 , children from both experimental and control groups performed again the cognitive battery.
Result


The repeated measures ANOVA showed a significant effect of the ESA Program on the TMT B and on Digit Span Backward, but no significant effects were found on Digit Span Forward and Stroop Task.
Conclusion


The introduction of a sport program enriched with cognitive stimuli has beneficial effects for children working memory and cognitive flexibility.",2020,"The repeated measures ANOVA showed a significant effect of the ESA Program on the TMT B and on Digit Span Backward, but no significant effects were found on Digit Span Forward and Stroop Task.
","[""Children's Executive Functions"", '357 children from four European countries (Italy, Germany, Lithuania, and Turkey) performed a']","['physical exercise', 'cognitive test battery made up of Digit Span Forward/Backward, Stroop Task, and Trail Making Test (TMT', 'Enriched Sport Program', 'sport program enriched with cognitive stimuli', 'physical education program, elaborated within the Enriched Sports Activity Program (ESA Program']","['executive functions (EFs', 'Digit Span Forward and Stroop Task', 'TMT B and on Digit Span Backward']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0023879', 'cui_str': 'Lithuania'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439781', 'cui_str': 'Backward'}]",357.0,0.0123656,"The repeated measures ANOVA showed a significant effect of the ESA Program on the TMT B and on Digit Span Backward, but no significant effects were found on Digit Span Forward and Stroop Task.
","[{'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Gentile', 'Affiliation': 'Ph.D. Program in Health Promotion and Cognitive Sciences, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Boca', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Fatma Neşe', 'Initials': 'FN', 'LastName': 'Şahin', 'Affiliation': 'Faculty of Sports Science, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Özkan', 'Initials': 'Ö', 'LastName': 'Güler', 'Affiliation': 'Faculty of Sports Science, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Pajaujiene', 'Affiliation': 'Department of Coaching Science, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Vinga', 'Initials': 'V', 'LastName': 'Indriuniene', 'Affiliation': 'Department of Physical and Social Education, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Demetriou', 'Affiliation': 'Department of Sport and Health Sciences, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sturm', 'Affiliation': 'Department of Sport and Health Sciences, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Gómez-López', 'Affiliation': 'Department of Physical Activity and Sport, Faculty of Sports Sciences, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Alesi', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00657']
1909,32411218,A Scoping Review on the Attributes of Cluster Randomized Controlled Trials in Long-Term Care Facilities.,"Cluster randomized trial design, where groups of participants are randomized instead of individual participants, is increasingly being used in long-term care research. The purpose of this review was to determine the characteristics of cluster randomized trials in long-term care facilities. A medical librarian conducted the literature search. Two independent reviewers reviewed each paper. Studies were included if the design was cluster randomized and participants were from long-term care facilities. For each included study, two independent data extractors captured data on study attributes, including: journal, location, year published, author discipline, funding, methodology, number of participants, and intervention target. The literature search yielded 7,679 unique studies, with 195 studies meeting the selection criteria and being included for data extraction. The included studies were published between 1976 and 2017, with 53% of studies published after 2009. The term cluster randomized was in the title of only 45% of the studies. The studies were conducted worldwide; the United States had the largest number of studies (23%), followed by the United Kingdom (18%). Ten percent of studies were published in journals with an impact factor >10. The most frequent discipline of the first and last authors was medicine (34%), followed by nursing (17%). Forty-nine percent of the studies had government funding, while only 20% had medical industry funding. In studies with <1000 residents, 85% of the studies obtained consent from the resident and/or their proxy, while in studies with ≥ 1000 residents, it was 31%. The most frequent intervention targets were infection (13%), falls/fracture (13%), and behavior/physical restraint (13%). Cluster randomized controlled trials in long-term care have a unique set of characteristics. Results of this review will provide guidance to researchers conducting studies in long-term care facilities.",2020,"The most frequent discipline of the first and last authors was medicine (34%), followed by nursing (17%).","['Forty-nine percent of the studies had government funding, while only 20% had medical industry funding', '7,679 unique studies, with 195 studies meeting the selection criteria and being included for data extraction']",[],"['behavior/physical restraint', 'falls/fracture']","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0376244', 'cui_str': 'funding'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",,0.116288,"The most frequent discipline of the first and last authors was medicine (34%), followed by nursing (17%).","[{'ForeName': 'Roni Y', 'Initials': 'RY', 'LastName': 'Kraut', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2T4.'}, {'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Katz', 'Affiliation': 'Winnipeg Public Library, Winnipeg, Manitoba, Canada R3C 3P5.'}, {'ForeName': 'Oksana', 'Initials': 'O', 'LastName': 'Babenko', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2T4.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Diaz Carvallo', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2T4.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Alexanders', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2T4.'}, {'ForeName': 'Derek S', 'Initials': 'DS', 'LastName': 'Chan', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2T4.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Campbell', 'Affiliation': 'John W. Scott Health Sciences, University of Alberta, Edmonton, Alberta, Canada T6G 2R7.'}, {'ForeName': 'Dean T', 'Initials': 'DT', 'LastName': 'Eurich', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada T6G 2G3.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Garrison', 'Affiliation': 'Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2T4.'}]",Current gerontology and geriatrics research,['10.1155/2020/6085368']
1910,29551921,Effect of dexmedetomidine-induced anesthesia on the postoperative cognitive function of elder patients after laparoscopic ovarian cystectomy.,"Objective


To investigate the effect of dexmedetomidine at maintenance dose on the postoperative function of elder patients after general anesthesia for laparoscopic ovarian cystectomy.
Methods


We enrolled a total of 96 elder patients who were admitted to this hospital for laparoscopic ovarian cystectomy under general anesthesia between March 2015 and March 2017, and divided them into two groups, Group A (n = 48) and B (n = 48). Patients in both groups received the same methods for anesthesia induction and maintenance drugs. At the beginning of operation, patients in Group A received the intravenous injection of dexmedetomidine (0.8 μg/kg) followed by maintenance dose [0.5 μg/(kg h)] to the end of operation, while those in Group B underwent intravenous injection of 0.9% normal saline at the same rate, during which blood pressure, heart rate, oxyhemoglobin saturation and dosage of anesthetics at T1 (5 min after being delivered into the operation room), T2 (immediately after anesthesia induction), T3 (immediately after intubation), T4 (immediately after operation), T5 (immediately after end of operation) and T6 (immediately after extubation). Then, the levels of NSE, IL-6, CRP and HMGB1 were compared between two groups at 24 h before the operation, at the end, 24 h, 3 d and 7 d after operation. Besides, we also compared the postoperative cognitive functions and incidence of adverse reactions at 1 d before, 1, 2, 3 and 7 d after operation through MOCA scales.
Results


At T3, T4 and T6, comparisons of the average arterial pressure and heart rate showed that the differences between the two groups had statistical significance ( p  < .05). At the end of operation, and at 24 h, 3 d and 7 d after operation, we found that the levels of IL-6 and CRP in patients of two groups were all significantly elevated when compared with those before operation; at the end of operation and at 24 h and 3 d after operation, the levels of IL-6 and CRP in the Group B were higher than those in the Group A, and the differences had statistical significance ( p  < .05). At the end of operation and at 24 h and 3 d after operation, the levels of NSE and HMGB1 in two group were higher than those before operation, and a more significant elevation was identified in Group B with statistically significant differences ( p  < .05); at 7 d after operation, a decreasing trend was found in the level of HMGB1, which, however, remained higher than the preoperative level, and the level in Group B was still higher than that in Group A with statistically significant differences ( p  < .05). At 2 d after operation, we found that the scores of MOCA in the Group B were remarkably decreased in comparison with the scores in Group A with a statistically significant difference ( p  < .05). Moreover, the incidence rate of postoperative cognitive dysfunction (POCD) in the Group A was significantly lower than that in the Group B, and the difference had statistical significance ( p  < .05).
Conclusion


Dexmedetomidine can ameliorate the postoperative cognitive functions of elder patients who received the laparoscopic ovarian cystectomy under general anesthesia, and effectively decrease the incidence rate of POCD without any obvious or severe adverse reaction. Thus, it can serve as a kind of adjuvant drug for general anesthesia in clinical practice.",2017,"At the end of operation and at 24 h and 3 d after operation, the levels of NSE and HMGB1 in two group were higher than those before operation, and a more significant elevation was identified in Group B with statistically significant differences ( p  < .05); at 7 d after operation, a decreasing trend was found in the level of HMGB1, which, however, remained higher than the preoperative level, and the level in Group B was still higher than that in Group A with statistically significant differences ( p  < .05).","['elder patients after general anesthesia for laparoscopic ovarian cystectomy', 'elder patients after laparoscopic ovarian cystectomy', '96 elder patients who were admitted to this hospital for laparoscopic ovarian cystectomy under general anesthesia between March 2015 and March 2017']","['Dexmedetomidine', 'laparoscopic ovarian cystectomy', 'dexmedetomidine-induced anesthesia', 'dexmedetomidine', 'intravenous injection of 0.9% normal saline']","['scores of MOCA', 'incidence rate of postoperative cognitive dysfunction (POCD', 'levels of NSE, IL-6, CRP and HMGB1', 'postoperative cognitive function', 'average arterial pressure and heart rate', 'levels of IL-6 and CRP', 'postoperative cognitive functions and incidence of adverse reactions', 'postoperative cognitive functions', 'incidence rate of POCD', 'level of HMGB1', 'levels of NSE and HMGB1']","[{'cui': 'C0331055', 'cui_str': 'Elder Plant'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0195488', 'cui_str': 'Removal of ovarian cyst (procedure)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0195488', 'cui_str': 'Removal of ovarian cyst (procedure)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0021494', 'cui_str': 'Intravenous Injections'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0019796', 'cui_str': 'Heparin-Binding Protein p30'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",96.0,0.0175807,"At the end of operation and at 24 h and 3 d after operation, the levels of NSE and HMGB1 in two group were higher than those before operation, and a more significant elevation was identified in Group B with statistically significant differences ( p  < .05); at 7 d after operation, a decreasing trend was found in the level of HMGB1, which, however, remained higher than the preoperative level, and the level in Group B was still higher than that in Group A with statistically significant differences ( p  < .05).","[{'ForeName': 'Hui-Ying', 'Initials': 'HY', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Guang-Hua', 'Initials': 'GH', 'LastName': 'Fu', 'Affiliation': ""Department of Anesthesiology, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Gui-Sheng', 'Initials': 'GS', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Liaocheng People's Hospital, Liaocheng 252000, China.""}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2017.11.010']
1911,29551930,Comparative study of ticagrelor and clopidogrel in therapeutic effect of acute myocardial infarction patients undergoing percutaneous coronary intervention.,"Objectives


Comparison of Ticagrelor vs clopidogrel in antiplatelet therapeutic effect of acute myocardial infarction patients undergoing percutaneous coronary intervention.
Methods


The study focused on 2000 acute myocardial infarction patients undergoing percutaneous coronary intervention (PCI) in our hospital from January 2013 to December 2015. To reduce the formation of acute stent thrombosis caused by clopidogrel resistance, we had two options, one was to double the dosage of clopidogrel, and the other was to substitute ticagrelor for clopidogrel. Based on random number table method, the 2000 patients were divided into experimental group and control group, each containing 1,000 patients. The patients in experimental group took 180 mg ticagrelor before PCI and 90 mg ticagrelor twice a day after PCI (Gu, 2016). In contrast, the patients control group took 600 mg clopidogrel before PCI and 150 mg clopidogrel once a day after PCI. Both groups were drawn 2.7 ml of fasting venous blood for platelet aggregation rate test before PCI and 2 h, 24 h, 7 days after PCI respectively. Turbidimetric method was used to measure the ADP-induced platelet aggregation rate and observe change of platelet aggregation rate and success rate. Incidence of liver and kidney malfunction and adverse actions were monitored. All patients accepted a 6-month of follow-up examination to record and compare incidences of major adverse cardiac and cerebrovascular events. The statistical results of both groups are analyzed and compared.
Results


The platelet aggregation rate of experimental group before PCI and 2 h, 24 h, 7 days after PCI was 59.71% ± 7.24%, 59.20% ± 7.70%, 48.66% ± 7.80% and 43.39% ± 8.28%; The control group was 58.04% ± 5.61%, 56.25% ± 6.02%, 55.68% ± 3.14%, 53.94% ± 5.30%; Comparing the platelet aggregation rate of different time, P was less than 0.05. The success rate of platelet aggregation of experimental group and control group was 80.56% and 46.86% respectively. There were significant differences between the two groups and the P was less than .05. The postoperative serum creatinine level of experimental group was higher than that in the control group (P < .05). The incidence of adverse reactions in the experimental group was significantly lower than that of the control group. There were significant differences between the two groups and the difference was of statistical significance (P < .05). According to the 5-month follow-up examination: the incidence of major adverse cardiac and cerebrovascular events in experimental group was 2.60% (52/2000) ,while the control group was 13.00% (260/2000) . There were significant differences between the two groups and the difference was of statistical significance (P < .05).
Conclusions


Compared with clopidogrel, ticagrelor can achieve better n antiplatelet effect for patients with acute myocardial infarction undergoing percutaneous coronary intervention (PCI). It can effectively reduce the incidence of postoperative adverse cardiac and cerebrovascular events and control the rate of adverse reactions within the acceptable range.",2017,The postoperative serum creatinine level of experimental group was higher than that in the control group (P < .05).,"['in our hospital from January 2013 to December 2015', 'patients with acute myocardial infarction undergoing percutaneous coronary intervention (PCI', '2000 acute myocardial infarction patients undergoing', '2000 patients were divided into experimental group and control group, each containing 1,000 patients', 'acute myocardial infarction patients undergoing percutaneous coronary intervention']","['ticagrelor and clopidogrel', 'ticagrelor', 'percutaneous coronary intervention (PCI', 'Ticagrelor vs clopidogrel', 'clopidogrel']","['incidence of major adverse cardiac and cerebrovascular events', 'Incidence of liver and kidney malfunction and adverse actions', 'platelet aggregation rate', 'incidences of major adverse cardiac and cerebrovascular events', 'postoperative serum creatinine level', 'success rate of platelet aggregation', 'platelet aggregation rate and success rate', 'incidence of adverse reactions', 'incidence of postoperative adverse cardiac and cerebrovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",,0.0227384,The postoperative serum creatinine level of experimental group was higher than that in the control group (P < .05).,"[{'ForeName': 'Guangtao', 'Initials': 'G', 'LastName': 'Yao', 'Affiliation': 'Department of Cardiology, Jinan Central Hospital Affiliated to Shandong University, Jinan 250013, China.'}, {'ForeName': 'Guohai', 'Initials': 'G', 'LastName': 'Su', 'Affiliation': 'Department of Cardiology, Jinan Central Hospital Affiliated to Shandong University, Jinan 250013, China.'}, {'ForeName': 'Keqing', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Dezhou People's Hospital, Dezhou 253014, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Jinan Central Hospital Affiliated to Shandong University, Jinan 250013, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Dong', 'Affiliation': ""Department of Cardiology, Dezhou People's Hospital, Dezhou 253014, China.""}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2017.11.020']
1912,31876673,Heavy Resistance Training in Breast Cancer Patients Undergoing Adjuvant Therapy.,"BACKGROUND AND PURPOSE


Adjuvant breast cancer therapy may reduce maximal muscle strength, muscle mass, and functional performance. Although maximal strength training (MST) has the potential to counteract this debilitating outcome and is shown to be superior to low- and moderate-intensity strength training, it is unknown if it can elicit effective adaptations in patients suffering treatment-induced adverse side effects.
METHODS


Fifty-five newly diagnosed stage I to III breast cancer patients (49 ± 7 yr) scheduled for adjuvant therapy were randomized to MST or a control group. The MST group performed 4 × 4 repetitions of dynamic leg press at approximately 90% of one-repetition maximum (1RM) twice a week for 12 wk.
RESULTS


In the MST group, improvements in 1RM (20% ± 8%; P < 0.001) were accompanied by improved walking economy (9% ± 8%) and increased time to exhaustion during incremental walking (9% ± 8%; both P < 0.01). Moreover, the MST group increased 6-min walking distance (6MWD; 10% ± 7%), and chair rising (30% ± 20%) and stair climbing performance (12% ± 7%; all P < 0.001). All MST-induced improvements were different from the control group (P < 0.01) which reduced their 1RM (9% ± 5%), walking economy (4% ± 4%), time to exhaustion (10% ± 8%), 6MWD (5% ± 5%), chair rising performance (12% ± 12%), and stair climbing performance (6% ± 8%; all P < 0.01). Finally, although MST maintained estimated quadriceps femoris muscle mass, a decrease was observed in the control group (7% ± 10%; P < 0.001). The change in 1RM correlated with the change in walking economy (r = 0.754), time to exhaustion (r = 0.793), 6MWD (r = 0.807), chair rising performance (r = 0.808), and stair climbing performance (r = 0.754; all P < 0.001).
CONCLUSIONS


Lower-extremity MST effectively increases lower-extremity maximal muscle strength in breast cancer patients undergoing adjuvant therapy and results in improved work economy, functional performance, and maintenance of muscle mass. These results advocate that MST should be considered in breast cancer treatment.",2020,"Lower extremity MST effectively increases lower extremity maximal muscle strength in breast cancer patients undergoing adjuvant therapy and results in improved work economy, functional performance, and maintenance of muscle mass.","['Fifty-five newly diagnosed stage', 'Breast Cancer Patients Undergoing Adjuvant Therapy', 'breast cancer patients undergoing', 'patients suffering treatment-induced adverse side effects', 'I-III breast cancer patients (49±7 years) scheduled for adjuvant therapy']","['adjuvant therapy', 'MST', 'maximal strength training (MST', 'Heavy Resistance Training']","['1RM', '6 minutes walking distance (6MWD; 10±7%), and chair rising', 'work economy, functional performance, and maintenance of muscle mass', 'quadriceps femoris muscle mass', 'change in 1RM', 'time to exhaustion', 'maximal muscle strength, muscle mass, and functional performance', 'time to exhaustion (10±8%), 6MWD (5±5%), chair rising performance', 'walking economy', 'stair climbing performance', 'time to exhaustion (r=0.793), 6MWD (r=0.807), chair rising performance (r=0.808), and stair climbing performance', 'extremity maximal muscle strength']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C3853978'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}]",55.0,0.0130742,"Lower extremity MST effectively increases lower extremity maximal muscle strength in breast cancer patients undergoing adjuvant therapy and results in improved work economy, functional performance, and maintenance of muscle mass.","[{'ForeName': 'Rūdolfs', 'Initials': 'R', 'LastName': 'Cešeiko', 'Affiliation': 'Department of Rehabilitation, Rīga Stradiņš University, Rīga, LATVIA.'}, {'ForeName': 'Simon Nørskov', 'Initials': 'SN', 'LastName': 'Thomsen', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, DENMARK.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Tomsone', 'Affiliation': 'Department of Rehabilitation, Rīga Stradiņš University, Rīga, LATVIA.'}, {'ForeName': 'Jānis', 'Initials': 'J', 'LastName': 'Eglītis', 'Affiliation': 'The Oncology Centre of Latvia, Rīga, LATVIA.'}, {'ForeName': 'Aivars', 'Initials': 'A', 'LastName': 'Vētra', 'Affiliation': 'Department of Rehabilitation, Rīga Stradiņš University, Rīga, LATVIA.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Srebnijs', 'Affiliation': 'Faculty of Medicine, University of Latvia, Rīga, LATVIA.'}, {'ForeName': 'Mihails', 'Initials': 'M', 'LastName': 'Timofejevs', 'Affiliation': 'The Oncology Centre of Latvia, Rīga, LATVIA.'}, {'ForeName': 'Egīls', 'Initials': 'E', 'LastName': 'Purmalis', 'Affiliation': 'The Oncology Centre of Latvia, Rīga, LATVIA.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Rīga Stradiņš University, Rīga, LATVIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002260']
1913,32411024,"Feasibility and Acceptability of a Student-Led Lifestyle (Diet and Exercise) Intervention Within a Residential Rehabilitation Setting for People With Severe Mental Illness, GO HEART (Group Occupation, Health, Exercise And Rehabilitation Treatment).","Purpose


People with severe mental illness (SMI) experience poor physical health and premature mortality, contributed significantly by modifiable lifestyle risk factors such as poor nutrition, low cardiorespiratory fitness, and physical inactivity. Lifestyle interventions can reduce cardiometabolic risk and confer a range of other positive mental and physical health benefits. We assessed the feasibility, acceptability, safety, and preliminary effectiveness of a lifestyle (combined dietary and exercise) intervention lead by senior exercise and dietetics students in a residential mental health rehabilitation setting.
Design


Single arm, prospective study evaluating outcomes pre and post a 10-week dietary and exercise intervention.
Method


People with SMI from three residential rehabilitation units participated in a mixed aerobic and resistance training exercise intervention three times per week that was combined with a dietary intervention (six individual and group sessions). Primary outcome considerations were feasibility (recruitment, retention, and participation rates), acceptability, and adverse events. Secondary outcomes were preliminary effectiveness; (functional exercise capacity, volume of exercise, and metabolic markers), psychiatric symptoms, quality of life, and attitudes to exercise.
Results


Forty-two participants were recruited (92% primary diagnosis of schizophrenia). Intervention feasibility was supported by high levels of recruitment (68%), retention (77%), and participation (70% exercise, 65% diet sessions); and the absence of serious adverse events. Significant improvements in functional exercise capacity, volume of exercise, general psychiatric symptoms, and negative psychotic symptoms occurred. Anthropometric and metabolic blood markers did not change. While the intervention was acceptable to participants, motivation for and perceived value of exercise reduced over 10 weeks.
Conclusions


A brief pragmatic student-led lifestyle intervention integrated into usual mental health care was feasible, acceptable, safe, and scalable across two additional mental health residential rehabilitation sites, and resulted in physical and mental health improvements. Increased frequency of dietary sessions and length of dietary intervention may improve metabolic outcomes in the future. People with SMI living in residential rehabilitation units should have access to lifestyle programs to address modifiable lifestyle risk factors. While this brief intervention was feasible and acceptable, this study highlights some of the challenges associated with maintaining motivation for healthy lifestyles for people with SMI. Longer term investigation of real-world lifestyle interventions is warranted, together with additional interventions that may support people with SMI to sustain motivation to address lifestyle factors.
Clinical Trial Registration


The trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), Unique Identifier: ACTRN 12618000478213, http://www.anzctr.org.au Universal trial number (UTN)-U1111-1211-4009.",2020,People with SMI living in residential rehabilitation units should have access to lifestyle programs to address modifiable lifestyle risk factors.,"['Forty-two participants were recruited (92% primary diagnosis of schizophrenia', 'People with SMI living in residential rehabilitation units', 'People with severe mental illness (SMI', 'healthy lifestyles for people with SMI', 'and dietetics students in a residential mental health rehabilitation setting', 'Method\n\n\nPeople with SMI from three residential rehabilitation units participated in a', 'People With Severe Mental Illness']","['dietary and exercise intervention', 'Lifestyle interventions', 'lifestyle (combined dietary and exercise) intervention lead by senior exercise', 'Intervention', 'Student-Led Lifestyle (Diet and Exercise', 'mixed aerobic and resistance training exercise intervention']","['Anthropometric and metabolic blood markers', 'feasibility, acceptability, safety', 'feasibility (recruitment, retention, and participation rates), acceptability, and adverse events', 'effectiveness; (functional exercise capacity, volume of exercise, and metabolic markers), psychiatric symptoms, quality of life, and attitudes to exercise', 'absence of serious adverse events', 'functional exercise capacity, volume of exercise, general psychiatric symptoms, and negative psychotic symptoms', 'cardiometabolic risk', 'metabolic outcomes', 'Feasibility and Acceptability']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0204512', 'cui_str': 'Psychiatric rehabilitation'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",42.0,0.0823209,People with SMI living in residential rehabilitation units should have access to lifestyle programs to address modifiable lifestyle risk factors.,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Korman', 'Affiliation': 'Addiction and Mental Health Services, Metro South Health Services, Brisbane, QLD, Australia.'}, {'ForeName': 'Harley', 'Initials': 'H', 'LastName': 'Fox', 'Affiliation': 'School of Medicine, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Skinner', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Dodd', 'Affiliation': 'Addiction and Mental Health Services, Metro South Health Services, Brisbane, QLD, Australia.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Suetani', 'Affiliation': 'Addiction and Mental Health Services, Metro South Health Services, Brisbane, QLD, Australia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Addiction and Mental Health Services, Metro South Health Services, Brisbane, QLD, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': 'Addiction and Mental Health Services, Metro South Health Services, Brisbane, QLD, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Dark', 'Affiliation': 'Addiction and Mental Health Services, Metro South Health Services, Brisbane, QLD, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Collins', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rosenbaum', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Siskind', 'Affiliation': 'Addiction and Mental Health Services, Metro South Health Services, Brisbane, QLD, Australia.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00319']
1914,31596213,Clinical- and Cost-Effectiveness of a Mandibular Advancement Device Versus Continuous Positive Airway Pressure in Moderate Obstructive Sleep Apnea.,"STUDY OBJECTIVES


Limited evidence exists on the cost-effectiveness of mandibular advancement device (MAD) compared to continuous positive airway pressure (CPAP) therapy in moderate obstructive sleep apnea (OSA). Therefore, this study compares the clinical and cost-effectiveness of MAD therapy with CPAP therapy in moderate OSA.
METHODS


In a multicentre randomized controlled trial, patients with an apnea-hypopnea index (AHI) of 15 to 30 events/h were randomized to either MAD or CPAP. Incremental cost-effectiveness and cost-utility ratios (ICER/ICUR, in terms of AHI reduction and quality-adjusted life-years [QALYs, based on the EuroQol Five-Dimension Quality of Life questionnaire]) were calculated after 12 months, all from a societal perspective.
RESULTS


In the 85 randomized patients (n = 42 CPAP, n = 43 MAD), AHI reduction was significantly greater with CPAP (median reduction AHI 18.3 [14.8-22.6] events/h) than with MAD therapy (median reduction AHI 13.5 [8.5-18.4] events/h) after 12 months. Societal costs after 12 months were higher for MAD than for CPAP (mean difference €2.156). MAD was less cost-effective than CPAP after 12 months (ICER -€305 [-€3.003 to €1.572] per AHI point improvement). However, in terms of QALY, MAD performed better than CPAP after 12 months (€33.701 [-€191.106 to €562.271] per QALY gained).
CONCLUSIONS


CPAP was more clinically effective (in terms of AHI reduction) and cost-effective than MAD. However, costs per QALY was better with MAD as compared to CPAP. Therefore, CPAP is the first-choice treatment option in moderate OSA and MAD may be a good alternative.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Identifier: NCT01588275.",2019,"However, in terms of QALY, MAD performed better than CPAP after 12 months (€33.701 [-€191.106 to €562.271] per QALY gained).
","['patients with an apnea-hypopnea index (AHI) of 15 to 30 events/h', 'moderate obstructive sleep apnea (OSA', 'Moderate Obstructive Sleep Apnea']","['MAD or CPAP', 'Mandibular Advancement Device Versus Continuous Positive Airway Pressure', 'MAD therapy with CPAP therapy', 'mandibular advancement device (MAD', 'CPAP', 'continuous positive airway pressure (CPAP) therapy']","['Incremental cost-effectiveness and cost-utility ratios (ICER/ICUR', 'Societal costs', 'AHI reduction and quality-adjusted life-years [QALYs, based on the EuroQol Five-Dimension Quality of Life questionnaire', 'costs per QALY', 'AHI reduction', 'AHI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0376461', 'cui_str': 'Mandibular Advancement'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",85.0,0.0515504,"However, in terms of QALY, MAD performed better than CPAP after 12 months (€33.701 [-€191.106 to €562.271] per QALY gained).
","[{'ForeName': 'Grietje E', 'Initials': 'GE', 'LastName': 'de Vries', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Aarnoud', 'Initials': 'A', 'LastName': 'Hoekema', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Johannes Q P J', 'Initials': 'JQPJ', 'LastName': 'Claessen', 'Affiliation': 'Department of Ear Nose and Throat surgery, Martini Hospital Groningen, The Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Jacobs', 'Affiliation': 'Department of Pulmonary Diseases, Martini Hospital Groningen, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van der Maten', 'Affiliation': 'Department of Pulmonary Diseases, Medical Center Leeuwarden, The Netherlands.'}, {'ForeName': 'Johannes H', 'Initials': 'JH', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Clinical Neurophysiology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Stegenga', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Wijkstra', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, The Netherlands.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7980']
1915,31264912,Correlates of Human Papillomavirus Vaccination and Association with HPV-16 and HPV-18 DNA Detection in Young Women.,"Background:  Despite a reduction in the prevalence of vaccine-preventable types of human papillomavirus (HPV), attributed to increased HPV vaccine uptake, HPV continues to be a major cause of cancer in the United States.  Methods:  We assessed factors associated with self-reported HPV vaccine uptake, HPV vaccination effectiveness, using DNA testing to assess HPV types 16 and/or 18 (HPV 16/18) positivity, and patterns of HPV vaccination in 375 women aged 21-29 years who were eligible to receive catch-up vaccination, using baseline data collected from March 2012 to December 2014 from a randomized controlled trial evaluating a novel approach to cervical cancer screening.  Results:  More than half ( n  = 228, 60.8%) of participants reported receipt of at least one HPV vaccine dose and 16 (4.3%) tested positive for HPV 16/18 at baseline. College-educated participants were four times more likely to have been vaccinated than those reporting high school education or less. 56.5% of HPV-vaccinated participants reported first dose after age 18 and 68.4% after first vaginal intercourse. Women vaccinated after age 18 and women vaccinated after first vaginal intercourse were somewhat more likely to be infected with HPV 16/18 infection compared with women vaccinated earlier, but these associations did not reach statistical significance.  Conclusions:  HPV vaccination is common among college-educated women in the catch-up population but less common among those without college education. Contrary to current guidelines, catch-up females frequently obtain HPV vaccination after age 18 and first vaginal intercourse. Women without a college education represent an ideal population for targeted HPV vaccination efforts that emphasize vaccination before sexual debut.",2019,"Women vaccinated after age 18 and women vaccinated after first vaginal intercourse were somewhat more likely to be infected with HPV 16/18 infection compared with women vaccinated earlier, but these associations did not reach statistical significance.  ","['college-educated women', 'College-educated participants', 'Young Women', '375 women aged 21-29 years who were eligible to receive catch-up vaccination, using baseline data collected from March 2012 to December 2014']","['novel approach to cervical cancer screening', 'HPV vaccination', 'HPV-16 and HPV-18 DNA Detection']","['HPV vaccine uptake', 'HPV vaccine uptake, HPV vaccination effectiveness']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0999806', 'cui_str': 'Human papillomavirus 16'}, {'cui': 'C0999807', 'cui_str': 'Human papillomavirus 18'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",375.0,0.227387,"Women vaccinated after age 18 and women vaccinated after first vaginal intercourse were somewhat more likely to be infected with HPV 16/18 infection compared with women vaccinated earlier, but these associations did not reach statistical significance.  ","[{'ForeName': 'Molly A', 'Initials': 'MA', 'LastName': 'Feder', 'Affiliation': 'Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington.'}, {'ForeName': 'Shalini L', 'Initials': 'SL', 'LastName': 'Kulasingam', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, Minnesota.'}, {'ForeName': 'Nancy B', 'Initials': 'NB', 'LastName': 'Kiviat', 'Affiliation': 'Department of Pathology, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Nelson', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health, Bloomington, Indiana.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Winer', 'Affiliation': 'Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington.'}, {'ForeName': 'Hilary K', 'Initials': 'HK', 'LastName': 'Whitham', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, Minnesota.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Hawes', 'Affiliation': 'Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7340']
1916,29551928,Effect on HRV of archer athletes one day before competition after three different abdominal respiratory frequency.,"Purpose


To study the effect on HRV of archer athletes one day before competition after three different abdominal respiratory frequencies.
Methods


Eight elite archers performed three different respiratory frequency tests, HRV were recorded in pre-, during, and post-frequency control in frequency 16 (F16 group, n = 8), 8 (F8 group, n = 8), and 5 (F5 group, n = 8) times per minute, and hoped to find a respiratory adjust way to reduce stress. RMSSD, RR_triangular index, TP, VLF, LF, HF and LF/HF were analyzed to describe the effect of respiratory frequency.
Result


The average RR separate, RR_triangular index and HF showed no significant change in three respiratory frequency ( P  > 0.05); LF increased significantly in F16 group, but LP of F8 and F5 group increased first then reduced ( P  < .05); VLF rose in F8 and F5 group ( P  < .05, respectively), the LF/HF has the similar change as the LF in all the groups.
Conclusion


The F16 group increased equilibrium of sympathetic and pneumogastric nerve system; F8 increase excitability of sympathetic nerve; mental fatigue remission in F5.",2017,"The average RR separate, RR_triangular index and HF showed no significant change in three respiratory frequency ( P  > 0.05); LF increased significantly in F16 group, but LP of F8 and F5 group increased first then reduced ( P  < .05); VLF rose in F8 and F5 group ( P  < .05, respectively), the LF/HF has the similar change as the LF in all the groups.
",[],[],"['equilibrium of sympathetic and pneumogastric nerve system; F8 increase excitability of sympathetic nerve; mental fatigue remission', 'LF', 'average RR separate, RR_triangular index and HF', 'RMSSD, RR_triangular index, TP, VLF, LF, HF and LF/HF', 'respiratory frequency', 'VLF']",[],[],"[{'cui': 'C0014653', 'cui_str': 'Balance (observable entity)'}, {'cui': 'C0042276', 'cui_str': 'Cranial Nerve X'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0015676', 'cui_str': 'Mental Fatigue'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}]",,0.0248918,"The average RR separate, RR_triangular index and HF showed no significant change in three respiratory frequency ( P  > 0.05); LF increased significantly in F16 group, but LP of F8 and F5 group increased first then reduced ( P  < .05); VLF rose in F8 and F5 group ( P  < .05, respectively), the LF/HF has the similar change as the LF in all the groups.
","[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Physical Education Department of Tianjin University of Technology and Education, Tianjin 300222, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'College of Post Graduated Student, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Section of Sports Medicine, Beijing Sport University, Beijing 100084, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2017.11.018']
1917,32411028,Commentary: Studying a Possible Placebo Effect of an Imaginary Low-Calorie Diet.,,2020,,[],['Imaginary Low-Calorie Diet'],[],[],"[{'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}]",[],,0.0703368,,"[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Dickinson', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University Bloomington, Bloomington, IN, United States.'}, {'ForeName': 'Greyson', 'Initials': 'G', 'LastName': 'Foote', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University Bloomington, Bloomington, IN, United States.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Allison', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University Bloomington, Bloomington, IN, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00329']
1918,29740250,Ilizarov method in combination with autologous mesenchymal stem cells from iliac crest shows improved outcome in tibial non-union.,"Autologous bone grafting and ilizarov technique are the preferred mode of treatment for bone nonunion, studies suggest that bone marrow derived mesenchymal stem cells can be effective in treatment of tibial non-union where there is length of bone defect. The current study investigates the beneficial clinical outcome of combining the ilizarov procedure with intraosseous injection of autologous mesenchymal stem cells. The open-label study enrolled 25 patients with infected tibial non-union at the Shanghai Fengxian District Central Hospital, Shanghai, China between April 2010 and July 2014. Patients were randomised to undergo the ilizarov procedure with ( n  = 11) or without ( n  = 13) intraosseous injection of bone marrow derived mesenchymal stem cells. All participants were followed prospectively until union was achieved (primary end point). The mean length of the bone defect in the Ilizarov group and Ilizarov group plus MSC group was 6.09 and 5.84 cm respectively. The mean time from the original injury to the time of the treatment for tibial non-union was 5-22 months (mean 13.5 months) for the Ilizarov group and 6-21 months (mean 13.5 months) for Ilizarov plus MSc group. All 24 patients were followed up for 12-34 months (mean 16 months). Both groups achieved the primary endpoint of stable union of the tibial fracture. No adverse events were observed in any of the group. Our study demonstrates that using autologous bone marrow derived mesenchymal stem cell as an add-on therapy to the ilizarov procedure shows significant clinical benefit in fixation of tibial non-union.",2018,No adverse events were observed in any of the group.,"['25 patients with infected tibial non-union at the Shanghai Fengxian District Central Hospital, Shanghai, China between April 2010 and July 2014']","['autologous bone marrow derived mesenchymal stem cell', 'ilizarov procedure with ', 'Autologous bone grafting and ilizarov technique', 'ilizarov procedure with intraosseous injection of autologous mesenchymal stem cells', 'intraosseous injection of bone marrow derived mesenchymal stem cells']","['stable union of the tibial fracture', 'mean length of the bone defect', 'adverse events', 'mean time', 'tibial non-union']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0282514', 'cui_str': 'Ilizarov Technic'}, {'cui': 'C0455106', 'cui_str': 'Intraosseous injection (procedure)'}]","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0040185', 'cui_str': 'Tibial Fractures'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",25.0,0.0169812,No adverse events were observed in any of the group.,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Shanghai Fengxian District Central Hospital, Shanghai 201499, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xue', 'Affiliation': 'Department of Orthopedics, Shanghai Fengxian District Central Hospital, Shanghai 201499, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Jun Xiao', 'Affiliation': 'Department of Orthopedics, Shanghai Fengxian District Central Hospital, Shanghai 201499, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2016.11.001']
1919,31166599,Efficacy and Safety of Alirocumab 300 mg Every 4 Weeks in Individuals With Type 2 Diabetes on Maximally Tolerated Statin.,"CONTEXT


In the ODYSSEY CHOICE I trial, alirocumab 300 mg every 4 weeks (Q4W) was assessed in patients with hypercholesterolemia. Alirocumab efficacy and safety were evaluated in a patient subgroup with type 2 diabetes mellitus (T2DM) and who were receiving maximally tolerated statins with or without other lipid-lowering therapies.
METHODS


Participants received either alirocumab 300 mg Q4W (n = 458, including 96 with T2DM) or placebo (n = 230, including 50 with T2DM) for 48 weeks, with alirocumab dose adjustment to 150 mg every 2 weeks at Week (W) 12 if W8 low-density lipoprotein cholesterol (LDL-C) levels were ≥70 mg/dL or ≥ 100 mg/dL, depending on cardiovascular risk, or if LDL-C reduction was <30% from baseline. Efficacy end points included percentage change from baseline to W24 for lipids, and time-averaged LDL-C over W21 to W24.
RESULTS


In individuals with T2DM, LDL-C reductions from baseline to W24 and the average of W21 to W24 were significantly greater with alirocumab (-61.6% and -68.8%, respectively) vs placebo. At W24, alirocumab significantly reduced levels of non-high-density lipoprotein cholesterol (HDL-C) and other lipids. At W24, 85.9% and 12.5% of individuals in the alirocumab and placebo groups, respectively, reached both non-HDL-C <100 mg/dL and LDL-C <70 mg/dL. At W12, In total, 18% of alirocumab-treated participants received dose adjustment. The most common treatment-emergent adverse events were upper respiratory tract infection and injection-site reaction. No clinically significant changes in fasting plasma glucose and glycated hemoglobin were observed.
CONCLUSION


In individuals with T2DM, alirocumab 300 mg Q4W was generally well tolerated and efficacious in reducing atherogenic lipoproteins.",2019,"At W24, alirocumab also significantly reduced levels of non-HDL-C, apolipoprotein B, triglycerides, and lipoprotein (a).","['patient subgroup with type 2 diabetes (T2DM) on maximally tolerated statins with/without other lipid-lowering therapies', 'patients with hypercholesterolemia', 'Individuals with Type 2 Diabetes on Maximally Tolerated Statin']","['alirocumab', 'Alirocumab 300 mg', 'placebo', 'alirocumab 300 mg Q4W']","['levels of non-HDL-C, apolipoprotein B, triglycerides, and lipoprotein (a', 'percentage change from baseline to W24 for LDL-C and other lipids, and time-averaged LDL-C', 'alirocumab efficacy and safety', 'fasting plasma glucose and glycated hemoglobin', 'tolerated and efficacious in reducing atherogenic lipoproteins', 'LDL-C reductions', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.124319,"At W24, alirocumab also significantly reduced levels of non-HDL-C, apolipoprotein B, triglycerides, and lipoprotein (a).","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller-Wieland', 'Affiliation': 'Department of Medicine I, University Hospital, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Rader', 'Affiliation': 'Department of Medicine and Genetics, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennysylvania.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Moriarty', 'Affiliation': 'Department of Internal Medicine, Division of Clinical Pharmacology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bergeron', 'Affiliation': 'Clinique des Maladies Lipidiques, Department of Medicine, Centre Hospitalier Universitaire de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Gisle', 'Initials': 'G', 'LastName': 'Langslet', 'Affiliation': 'Lipid Clinic, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Garen', 'Initials': 'G', 'LastName': 'Manvelian', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Bujas-Bobanovic', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Eli M', 'Initials': 'EM', 'LastName': 'Roth', 'Affiliation': 'The Sterling Research Group and University of Cincinnati, Cincinnati, Ohio.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-02703']
1920,30001244,Pregnancy outcomes and infant growth among babies with in-utero exposure to tenofovir-based preexposure prophylaxis for HIV prevention.,"BACKGROUND


Global guidelines recommend preexposure prophylaxis (PrEP) use by women at risk for HIV, including during pregnancy, a period with heightened HIV risk. However, data to support safety of PrEP use during pregnancy are limited, particularly from women using PrEP throughout pregnancy.
METHODS


In an open-label delivery study of PrEP integrated with ART for high-risk HIV serodiscordant couples in Kenya and Uganda (the Partners Demonstration Project), women who became pregnant while using PrEP were offered the option to continue PrEP throughout pregnancy. We compared pregnancy outcomes and 1-year infant growth from pregnancies with exposure to PrEP throughout pregnancy to those without any exposure, with data from the placebo arm of a prior efficacy trial of PrEP conducted in the same setting.
RESULTS


Outcomes from 30 women who elected to continue PrEP throughout pregnancy were compared with those from 96 pregnancies among PrEP-unexposed women. There were small nonsignificant decreases in the frequency of pregnancy loss [16.7% PrEP-exposed versus 23.5% PrEP-unexposed, adjusted odds ratio (aOR) = 0.59, P = 0.4] and preterm delivery [0 versus 7.7%, (aOR) = 0.54, exact P = 0.6]. No congenital anomalies occurred among PrEP-exposed infants. PrEP-exposed infants had slightly lower adjusted mean z-scores for length (-1.73 versus -0.79, P = 0.05) and head circumference (0.24 versus 1.07, P = 0.04) 1 month after birth but were comparable to PrEP-unexposed infants in these measurements 1 year after birth.
CONCLUSION


This first evaluation among women using PrEP throughout pregnancy indicates no greater frequency of adverse pregnancy outcomes or restricted infant growth; these findings support recommendations permitting PrEP use during pregnancy.",2018,This first evaluation among women using PrEP throughout pregnancy indicates no greater frequency of adverse pregnancy outcomes or restricted infant growth; these findings support recommendations permitting PrEP use during pregnancy.,"['high-risk HIV serodiscordant couples in Kenya and Uganda (the Partners Demonstration Project), women who became pregnant while using PrEP', 'babies with in-utero exposure to tenofovir-based preexposure prophylaxis for HIV prevention', '30 women who elected to continue PrEP throughout pregnancy']","['PrEP integrated with ART', 'placebo', 'preexposure prophylaxis (PrEP']","['preterm delivery', 'frequency of pregnancy loss', 'head circumference', 'congenital anomalies', 'pregnancy outcomes and 1-year infant growth']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.0809967,This first evaluation among women using PrEP throughout pregnancy indicates no greater frequency of adverse pregnancy outcomes or restricted infant growth; these findings support recommendations permitting PrEP use during pregnancy.,"[{'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Heffron', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Mugo', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Department of Pathology.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ngure', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Asiimwe', 'Affiliation': 'Kabwohe Clinical Research Center.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Katabira', 'Affiliation': 'Infectious Disease Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Odoyo', 'Affiliation': 'Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Tindimwebwa', 'Affiliation': 'Kabwohe Clinical Research Center.'}, {'ForeName': 'Nulu', 'Initials': 'N', 'LastName': 'Bulya', 'Affiliation': 'Infectious Disease Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000001867']
1921,29649996,"The effects of synbiotic supplementation on hormonal status, biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.","BACKGROUND


To our knowledge, no reports are available indicating the effects of synbiotic supplementation on hormonal status, biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome (PCOS). This research was done to assess the effects of synbiotic supplementation on hormonal status, biomarkers of inflammation and oxidative stress in subjects with PCOS.
METHODS


This randomized double-blind, placebo-controlled trial was conducted on 60 subjects diagnosed with PCOS according to the Rotterdam criteria. Subjects were randomly assigned into two groups to take either synbiotic (n = 30) or placebo (n = 30) for 12 weeks. Endocrine, inflammation and oxidative stress biomarkers were quantified at baseline and after the 12-week intervention.
RESULTS


After the 12-week intervention, compared with the placebo, synbiotic supplementation significantly increased serum sex hormone-binding globulin (SHBG) (changes from baseline in synbiotic group: + 19.8 ± 47.3 vs. in placebo group: + 0.5 ± 5.4 nmol/L, p = 0.01), plasma nitric oxide (NO) (changes from baseline in synbiotic group: + 5.5 ± 4.8 vs. in placebo group: + 0.3 ± 9.1 μmol/L, p = 0.006), and decreased modified Ferriman Gallwey (mF-G) scores (changes from baseline in synbiotic group: - 1.3 ± 2.5 vs. in placebo group: - 0.1 ± 0.5, p = 0.01) and serum high-sensitivity C-reactive protein (hs-CRP) (changes from baseline in synbiotic group: - 950.0 ± 2246.6 vs. in placebo group: + 335.3 ± 2466.9 ng/mL, p = 0.02). We did not observe any significant effect of synbiotic supplementation on other hormonal status and biomarkers of oxidative stress.
CONCLUSIONS


Overall, synbiotic supplementation for 12 weeks in PCOS women had beneficial effects on SHBG, mFG scores, hs-CRP and NO levels, but did not affect other hormonal status and biomarkers of oxidative stress.
TRIAL REGISTRATION


This study was retrospectively registered in the Iranian website ( www.irct.ir ) for registration of clinical trials ( IRCT201509115623N53 ), on 2015-09-27.",2018,"After the 12-week intervention, compared with the placebo, synbiotic supplementation significantly increased serum sex hormone-binding globulin (SHBG) (changes from baseline in synbiotic group: + 19.8 ± 47.3 vs. in placebo group: + 0.5 ± 5.4 nmol/L, p = 0.01), plasma nitric oxide (NO) (changes from baseline in synbiotic group: + 5.5 ± 4.8 vs. in placebo group: + 0.3 ± 9.1 μmol/L, p = 0.006), and decreased modified Ferriman Gallwey (mF-G) scores (changes from baseline in synbiotic group: - 1.3 ± 2.5 vs. in placebo group: - 0.1 ± 0.5, p = 0.01) and serum high-sensitivity C-reactive protein (hs-CRP) (changes from baseline in synbiotic group: - 950.0 ± 2246.6 vs. in placebo group: + 335.3 ± 2466.9 ng/mL, p = 0.02).","['60 subjects diagnosed with PCOS according to the Rotterdam criteria', 'subjects with polycystic ovary syndrome (PCOS', 'subjects with polycystic ovary syndrome', 'subjects with PCOS']","['synbiotic', 'placebo, synbiotic supplementation', 'placebo', 'synbiotic supplementation']","['SHBG, mFG scores, hs-CRP and NO levels', 'modified Ferriman Gallwey (mF-G) scores', 'hormonal status, biomarkers of inflammation and oxidative stress', 'serum high-sensitivity C-reactive protein (hs-CRP', 'Endocrine, inflammation and oxidative stress biomarkers', 'hormonal status and biomarkers of oxidative stress', 'plasma nitric oxide (NO', 'serum sex hormone-binding globulin (SHBG']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0312446', 'cui_str': 'Somatotropin binding globulin (substance)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}]",60.0,0.630378,"After the 12-week intervention, compared with the placebo, synbiotic supplementation significantly increased serum sex hormone-binding globulin (SHBG) (changes from baseline in synbiotic group: + 19.8 ± 47.3 vs. in placebo group: + 0.5 ± 5.4 nmol/L, p = 0.01), plasma nitric oxide (NO) (changes from baseline in synbiotic group: + 5.5 ± 4.8 vs. in placebo group: + 0.3 ± 9.1 μmol/L, p = 0.006), and decreased modified Ferriman Gallwey (mF-G) scores (changes from baseline in synbiotic group: - 1.3 ± 2.5 vs. in placebo group: - 0.1 ± 0.5, p = 0.01) and serum high-sensitivity C-reactive protein (hs-CRP) (changes from baseline in synbiotic group: - 950.0 ± 2246.6 vs. in placebo group: + 335.3 ± 2466.9 ng/mL, p = 0.02).","[{'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Nasri', 'Affiliation': 'Endocrinology and Metabolism Research Center, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Jamilian', 'Affiliation': 'Endocrinology and Metabolism Research Center, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Rahmani', 'Affiliation': 'Endocrinology and Metabolism Research Center, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, IR, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tajabadi-Ebrahimi', 'Affiliation': 'Faculty member of Science department, Science Faculty, Islamic Azad University, Tehran Central Branch, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, IR, Iran. asemi_r@yahoo.com.'}]",BMC endocrine disorders,['10.1186/s12902-018-0248-0']
1922,31553410,Effect of 1 or 2 Doses of Inclisiran on Low-Density Lipoprotein Cholesterol Levels: One-Year Follow-up of the ORION-1 Randomized Clinical Trial.,"Importance


Sustained reductions in low-density lipoprotein cholesterol (LDL-C) with lipid-lowering therapies that require frequent dosing are reliant on patient adherence, and poor adherence is associated with worse clinical outcomes.
Objective


To determine whether inclisiran, a small interfering RNA, reduces mean LDL-C exposure with an infrequent dosing regimen.
Design, Setting, and Participants


Prespecified analysis of a randomized, double-blind, placebo-controlled multicenter phase 2 clinical trial. Participants were followed up monthly for LDL-C levels and proprotein convertase subtilisin-kexin type 9 (PCSK9) measurements as well as safety until their LDL-C levels had returned to within 20% of their change from baseline (maximum 360 days). The study included patients with elevated LDL-C despite maximally tolerated statin therapy. Data were analyzed between January 11, 2016, and June 7, 2017.
Interventions


One dose (200, 300, or 500 mg on day 1) or 2 doses (100, 200, or 300 mg on days 1 and 90) of inclisiran sodium or placebo.
Main Outcomes and Measures


Duration of time to return to within 20% of change from baseline for LDL-C levels and time-averaged LDL-C reductions over 1 year.
Results


At baseline, among the 501 participants, 65% were men (n = 326 of 501), mean age was 63 years, 6% had familial hypercholesterolemia (n = 28 of 501), and 69% had established ASCVD (n = 347 of 501). Baseline LDL-C was 128 mg/dL among 501 randomized participants. The percentage of participants who were followed up to day 360 because their LDL-C levels had not returned to within 20% of their change from baseline ranged from 48.3% to 65.0% for those receiving a single dose and between 55.9% and 83.1% of those receiving 2 doses, with similar effects observed for PCSK9. Time-averaged reduction in LDL-C levels over 1 year after a single dose ranged from 29.5% to 38.7% (P < .001 between groups) and from 29.9% to 46.4% (P < .001 between groups) for those who received 2 doses. The 2-dose 300-mg regimen produced the highest proportion of responders at day 360 and the greatest mean reduction in LDL-C over 1 year. Incidence of adverse events was similar through to 1 year.
Conclusions and Relevance


Treatment with inclisiran resulted in durable reductions in LDL-C over 1 year. Inclisiran may offer a novel approach to LDL-C reduction with the convenience of infrequent dosing.
Trial Registration


ClinicalTrials.gov identifier: NCT02597127.",2019,Time-averaged reduction in LDL-C levels over 1 year after a single dose ranged from 29.5% to 38.7% (P < .001 between groups) and from 29.9% to 46.4% (P < .001 between groups) for those who received 2 doses.,"['501 participants, 65% were men (n\u2009=\u2009326 of 501), mean age was 63 years, 6% had familial hypercholesterolemia (n\u2009=\u200928 of 501), and 69% had established ASCVD (n\u2009=\u2009347 of 501', 'patients with elevated LDL-C despite maximally tolerated statin therapy']","['placebo', 'inclisiran sodium or placebo', 'Inclisiran']","['safety until their LDL-C levels', 'Incidence of adverse events', 'low-density lipoprotein cholesterol (LDL-C', 'Measures\n\n\nDuration of time to return to within 20% of change from baseline for LDL-C levels and time-averaged LDL-C reductions', 'LDL-C levels', 'Low-Density Lipoprotein Cholesterol Levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020445', 'cui_str': 'Hyperbetalipoproteinemia'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4307388', 'cui_str': 'inclisiran'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",501.0,0.524868,Time-averaged reduction in LDL-C levels over 1 year after a single dose ranged from 29.5% to 38.7% (P < .001 between groups) and from 29.9% to 46.4% (P < .001 between groups) for those who received 2 doses.,"[{'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, Charing Cross Hospital, London, England.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Stoekenbroek', 'Affiliation': 'The Medicines Company, Parsippany, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kallend', 'Affiliation': 'The Medicines Company, Parsippany, New Jersey.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Nishikido', 'Affiliation': 'Cardiovascular Medicine, Saga University, Nabeshima, Saga, Japan.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Charité-Universitats medizin Berlin, Berlin, Germany.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Wright', 'Affiliation': 'Department of Cardiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Peter L J', 'Initials': 'PLJ', 'LastName': 'Wijngaard', 'Affiliation': 'The Medicines Company, Parsippany, New Jersey.'}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': 'University of Amsterdam, Amsterdam, the Netherlands.'}]",JAMA cardiology,['10.1001/jamacardio.2019.3502']
1923,29656569,Ghanaian parents' perceptions of pre and postnatal nutrient supplements and their effects.,"Small-quantity lipid-based nutrient supplements (SQ-LNS) have been studied in efficacy and effectiveness trials, but little is known about how parents perceive the products and their effects. In a randomised trial in Ghana, efficacy of SQ-LNS provided to women during pregnancy and the first 6 months postpartum and to their children from 6 to 18 months of age was assessed by comparison with iron-folic acid (IFA) capsules and multiple micronutrient (MMN) capsules provided to women. In a follow-up study conducted when the index children from the original trial were between 4 and 6 years of age, we used survey-based methods to assess retrospective and current parental perceptions of nutrient supplements generally and of SQ-LNS and their effects compared with perceptions IFA and MMN capsules. Most parents perceived that the assigned supplements (SQ-LNS, IFA, or MMN) positively impacted the mother during pregnancy (approximately 89% of both mothers and fathers) and during lactation (84% of mothers and 86% of fathers). Almost all (≥90%) of mothers and fathers perceived that the assigned supplement positively impacted the index child and expected continued positive impacts on the child's health and human capital into the future. A smaller percentage of parents perceived negative impacts of the supplements (7%-17% of mothers and 4%-12% of fathers). Perceptions of positive impacts and of negative impacts did not differ by intervention group. The results suggest that similar populations would likely be receptive to programs to deliver SQ-LNS or micronutrient capsules.",2018,Perceptions of positive impacts and of negative impacts did not differ by intervention group.,['women during pregnancy and the first 6\xa0months postpartum and to their children from 6 to 18\xa0months of age was assessed by comparison with iron-folic acid (IFA) capsules and multiple micronutrient (MMN) capsules provided to women'],"['perceptions IFA and MMN capsules', 'SQ-LNS', 'Small-quantity lipid-based nutrient supplements (SQ-LNS']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]",[],,0.0534114,Perceptions of positive impacts and of negative impacts did not differ by intervention group.,"[{'ForeName': 'Katherine P', 'Initials': 'KP', 'LastName': 'Adams', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Okronipa', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Adu-Afarwuah', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Arimond', 'Affiliation': 'Intake-Center for Dietary Assessment, FHI 360, Washington, District of Columbia, USA.'}, {'ForeName': 'Sika', 'Initials': 'S', 'LastName': 'Kumordzie', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Brietta M', 'Initials': 'BM', 'LastName': 'Oaks', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, Rhode Island, USA.'}, {'ForeName': 'Maku E', 'Initials': 'ME', 'LastName': 'Ocansey', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Young', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Vosti', 'Affiliation': 'Department of Agricultural and Resource Economics, University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, Davis, California, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12608']
1924,31637577,Cabozantinib exposure-response analyses of efficacy and safety in patients with advanced hepatocellular carcinoma.,"Cabozantinib, a multi-kinase inhibitor, is approved in the United States and European Union for treatment of patients with hepatocellular carcinoma following prior sorafenib treatment. In the Phase III CELESTIAL trial, hepatocellular carcinoma patients receiving cabozantinib showed longer overall survival (OS) and progression-free survival (PFS) than those receiving placebo. The approved cabozantinib (Cabometyx ® ) dose is 60 mg once daily with allowable dose modifications to manage adverse events (AE). Time-to-event Cox proportional hazard exposure-response (ER) models were developed to characterize the relationship between predicted cabozantinib exposure and the likelihood of various efficacy and safety endpoints. The ER models were used to predict hazard ratios (HR) for efficacy and safety endpoints for starting doses of 60, 40, or 20 mg daily. Statistically significant relationships between cabozantinib exposure and efficacy and safety endpoints were observed. For efficacy endpoints, predicted HR were lower for OS and PFS at 40 and 60 mg relative to the 20 mg dose: HR for death (OS) are 0.84 (40 mg) and 0.70 (60 mg); HR for disease progression/death (PFS) are 0.73 (40 mg) and 0.62 (60 mg). For safety endpoints, predicted HR were lower for palmar-plantar erythrodysaesthesia (PPE), diarrhea, and hypertension at 20 or 40 mg relative to the 60 mg dose: HR for PPE are 0.31 (20 mg) and 0.66 (40 mg); HR for diarrhea are 0.61 (20 mg) and 0.86 (40 mg); HR for hypertension are 0.46 (20 mg) and 0.76 (40 mg). The rate of dose modifications was predicted to increase in patients with lower cabozantinib apparent clearance. OS and PFS showed the greatest benefit at the 60 mg dose. However, higher cabozantinib exposure was predicted to increase the likelihood of AE and subsequent dose reductions appeared to decrease these risks.",2019,"For efficacy endpoints, predicted HR were lower for OS and PFS at 40 and 60 mg relative to the 20 mg dose: HR for death (OS) are 0.84 (40 mg) and 0.70 (60 mg);","['patients with advanced hepatocellular carcinoma', 'patients with hepatocellular carcinoma following prior sorafenib treatment', 'hepatocellular carcinoma patients receiving']","['placebo', 'cabozantinib']","['overall survival (OS) and progression-free survival (PFS', 'cabozantinib exposure and efficacy and safety endpoints', 'efficacy and safety', 'hazard ratios (HR) for efficacy and safety endpoints', 'palmar-plantar erythrodysaesthesia (PPE), diarrhea, and hypertension', 'rate of dose modifications', 'Time-to-event Cox proportional hazard exposure-response (ER) models']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1184147', 'cui_str': 'Palmar (qualifier value)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0205351', 'cui_str': 'Proportional (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",,0.037904,"For efficacy endpoints, predicted HR were lower for OS and PFS at 40 and 60 mg relative to the 20 mg dose: HR for death (OS) are 0.84 (40 mg) and 0.70 (60 mg);","[{'ForeName': 'Linh', 'Initials': 'L', 'LastName': 'Nguyen', 'Affiliation': 'Exelixis, Inc, Alameda, CA, USA. linguyen@exelixis.com.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Chapel', 'Affiliation': 'Ann Arbor Pharmacometrics Group, Inc, Ann Arbor, MI, USA.'}, {'ForeName': 'Benjamin Duy', 'Initials': 'BD', 'LastName': 'Tran', 'Affiliation': 'Exelixis, Inc, Alameda, CA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lacy', 'Affiliation': 'Exelixis, Inc, Alameda, CA, USA.'}]",Journal of pharmacokinetics and pharmacodynamics,['10.1007/s10928-019-09659-y']
1925,31402384,Safety and Immunogenicity of a Respiratory Syncytial Virus Fusion (F) Protein Nanoparticle Vaccine in Healthy Third-Trimester Pregnant Women and Their Infants.,"BACKGROUND


Respiratory syncytial virus (RSV) is the leading cause of infant lower respiratory tract disease and hospitalization worldwide.
METHODS


Safety and immunogenicity of RSV fusion (F) protein nanoparticle vaccine or placebo were evaluated in 50 healthy third-trimester pregnant women. Assessments included vaccine tolerability and safety in women and infants, and RSV-specific antibody measures in women before and after vaccination, at delivery and post partum.
RESULTS


The vaccine was well tolerated; no meaningful differences in pregnancy or infant outcomes were observed between study groups. RSV-specific antibody levels increased significantly among vaccine recipients, including responses competitive with well-described monoclonal antibodies specific for multiple RSV neutralizing epitopes. No significant antibody increase was seen among placebo recipients, although a shallow upward trend across the RSV season was noted. Transplacental antibody transfer was 90%-120% across assays for infants of vaccinated women. Women with an interval of ≥30 days between vaccination and delivery demonstrated higher placental antibody transfer rates than women with an interval <30 days. Half-lives of RSV-specific antibodies in infants approximated 40 days. There was no evidence of severe RSV disease in infants of vaccinated mothers.
CONCLUSIONS


Data from this phase 2 study support a maternal immunization strategy to protect infants from RSV disease.
CLINICAL TRIALS REGISTRATION


NCT02247726.",2019,Women with an interval of ≥30 days between vaccination and delivery demonstrated higher placental antibody transfer rates than women with an interval <30 days.,"['Healthy Third-Trimester Pregnant Women and Their Infants', '50 healthy third-trimester pregnant women', 'infants of vaccinated women', 'women and infants, and RSV-specific antibody measures in women before and after vaccination, at delivery and postpartum']","['RSV fusion (F) protein nanoparticle vaccine or placebo', 'Respiratory Syncytial Virus Fusion (F) Protein Nanoparticle Vaccine']","['vaccine tolerability and safety', 'RSV season', 'Transplacental antibody transfer', 'RSV-specific antibody levels', 'severe RSV disease', 'placental antibody transfer rates', 'Safety and Immunogenicity']","[{'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein product'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0442375', 'cui_str': 'Transplacental approach (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C1277793', 'cui_str': 'Specific antibody measurement'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",50.0,0.298342,Women with an interval of ≥30 days between vaccination and delivery demonstrated higher placental antibody transfer rates than women with an interval <30 days.,"[{'ForeName': 'Flor M', 'Initials': 'FM', 'LastName': 'Muňoz', 'Affiliation': 'Baylor College of Medicine, Houston Texas.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Somia P', 'Initials': 'SP', 'LastName': 'Hickman', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland.'}, {'ForeName': 'Sapeckshita', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Piedra', 'Affiliation': 'Baylor College of Medicine, Houston Texas.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Glenn', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'August', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland.'}, {'ForeName': 'Iksung', 'Initials': 'I', 'LastName': 'Cho', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fries', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz390']
1926,32411250,Efficacy of Vitamin E in Methotrexate-Induced Hepatotoxicity in Rheumatoid Arthritis: An Open-Label Case-Control Study.,"Objective


To examine the efficacy of vitamin E in methotrexate- (MTX-) induced transaminitis in patients with rheumatoid arthritis (RA).
Methods


A case-control study was conducted at a tertiary rheumatology center for 12 months. Patients with RA on MTX and deranged aminotransferases were included. Patients with previous liver diseases, baseline transaminitis before methotrexate initiation, alcohol intake, muscle diseases, under hepatotoxic drugs, and  aminotransferases  > 3 times the upper normal limit were excluded. The patients were divided into treatment (vitamin E 400 mg bid for 3 months) and control groups (no vitamin E) using a random number table. The dose of MTX was unaltered. Follow-up was done after 3 and 6 months. Independent  t -test was done to compare means of two groups. Paired  t -test was done to compare differences in mean.
Results


Among 230 patients, 86.5% were female with a mean BMI of 25.9 ± 4.5 kg/m 2 . In the treatment group, SGPT and SGOT at baseline were 73.1 ± 20.4 and 60.2 ± 24.5 IU/L, respectively; at 3-month follow-up 44.6 ± 34.2 and 38.3 ± 20.8 IU/L, respectively; and at 6-month follow-up 40.4 ± 35.7 and 34.2 ± 21.9 IU/L, respectively. In the control group, SGPT and SGOT at baseline were 63.4 ± 15.1 and 46.8 ± 13.7 IU/L, respectively, and at 3-month follow-up 55.8 ± 45.9 and 45.5 ± 30.9 IU/L, respectively. Significant decrease in the level of aminotransferases was seen in the treatment group ( p  value < 0.001) and not in the control group ( p  values 0.161 and 0.728, respectively). The change in levels of SGPT and SGOT from baseline to 3 months of follow-up was statistically significant in between two study groups ( p  values 0.007 and <0.001, respectively). From the control group, 29 patients were crossed over to vitamin E for the next 3 months. SGPT and SGOT decreased from 97.6 ± 44.1 to 46.1 ± 40.9 and 69.3 ± 34.9 to 29.1 ± 11.6 IU/L, respectively ( p  values 0.031 and 0.017, respectively).
Conclusion


Vitamin E significantly attenuates MTX-induced transaminitis.",2020,"Significant decrease in the level of aminotransferases was seen in the treatment group ( p  value < 0.001) and not in the control group ( p  values 0.161 and 0.728, respectively).","['patients with rheumatoid arthritis (RA', 'Patients with previous liver diseases, baseline transaminitis before methotrexate initiation, alcohol intake, muscle diseases, under hepatotoxic drugs, and  aminotransferases  > 3 times the upper normal limit were excluded', 'Patients with RA on MTX and deranged aminotransferases were included', 'Rheumatoid Arthritis', '230 patients, 86.5% were female with a mean BMI of 25.9 ± 4.5\u2009kg/m 2 ']","['vitamin E', 'vitamin E 400\u2009mg bid for 3 months) and control groups (no vitamin E', 'Methotrexate-Induced Hepatotoxicity', 'MTX', 'Vitamin E', 'vitamin E in methotrexate- (MTX']","['levels of SGPT and SGOT', 'SGPT and SGOT', 'level of aminotransferases']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2242708', 'cui_str': 'Hypertransaminasaemia'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0442816', 'cui_str': 'Normal limits'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844009', 'cui_str': '4.5'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036828', 'cui_str': 'SGPT'}, {'cui': 'C0201899', 'cui_str': 'Aspartate aminotransferase measurement'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}]",29.0,0.0669268,"Significant decrease in the level of aminotransferases was seen in the treatment group ( p  value < 0.001) and not in the control group ( p  values 0.161 and 0.728, respectively).","[{'ForeName': 'Binit', 'Initials': 'B', 'LastName': 'Vaidya', 'Affiliation': 'National Center for Rheumatic Diseases (NCRD), Kathmandu, Nepal.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Bhochhibhoya', 'Affiliation': 'National Center for Rheumatic Diseases (NCRD), Kathmandu, Nepal.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Nakarmi', 'Affiliation': 'National Center for Rheumatic Diseases (NCRD), Kathmandu, Nepal.'}]",International journal of rheumatology,['10.1155/2020/5723485']
1927,29551918,Clinical evaluation of combination of dexmedetomidine and midazolam vs. dexmedetomidine alone for sedation during spinal anesthesia.,"Background


Dexmedetomidine is a useful sedative agent for spinal anesthesia. However, it has been reported to decreases heart rate in a dose-dependent manner. In the present study, we compared the bolus dose of midazolam and bolus loaded dexmedetomidine over 10 min to determine additional sedation methods.
Methods


A total of 100 patients who were classified as American Society of Anesthesiologists physical status I-II undergoing spinal anesthesia were randomly divided into two groups. In the combination of midazolam and dexmedetomidine group (group MD), 10 min after bolus loading of 0.05 mg/kg midazolam, 0.5 μg/kg/h dexmedetomidine was infused. In the dexmedetomidine group (group D), 1 μg/kg bolus dose of dexmedetomidine was infused over 10 min, and then 0.5 μg/kg/h dexmedetomidine was infused continuously.
Results


At 10 min, the sedation depth of the two groups was approximately the same. In both groups, the bispectral index (BIS) was within the optimal range of 55-80 and the Ramsay Sedation Scale score was within the optimal range of 3-5. Both patient and surgeon satisfaction with sedation did not differ between groups. At 10 min, heart rate (beats/min) was significantly lower (P < .01) in group D and mean blood pressure (mm Hg) was significantly lower (P < .01) in group MD. The prevalence of bradycardia (P = .714), hypotension (P = .089), and hypoxia (P = .495) did not differ statistically between the two groups.
Conclusions


Midazolam bolus and dexmedetomidine continuous infusion may be a useful additional sedation method for patients who have severe bradycardia.",2017,"At 10 min, heart rate (beats/min) was significantly lower (P < .01) in group D and mean blood pressure (mm Hg) was significantly lower (P < .01) in group MD.","['spinal anesthesia', '100 patients who were classified as American Society of Anesthesiologists physical status I-II undergoing spinal anesthesia', 'patients who have severe bradycardia', 'sedation during spinal anesthesia']","['Dexmedetomidine', 'midazolam', 'midazolam and bolus loaded dexmedetomidine', 'dexmedetomidine and midazolam vs. dexmedetomidine', 'midazolam and dexmedetomidine', 'dexmedetomidine', 'Midazolam', 'dexmedetomidine continuous infusion']","['heart rate', 'hypotension', 'sedation depth', 'hypoxia', 'prevalence of bradycardia', 'bispectral index (BIS', 'Ramsay Sedation Scale score', 'mean blood pressure']","[{'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",100.0,0.127071,"At 10 min, heart rate (beats/min) was significantly lower (P < .01) in group D and mean blood pressure (mm Hg) was significantly lower (P < .01) in group MD.","[{'ForeName': 'Ze-Yu', 'Initials': 'ZY', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Sichuan 81 Rehabilitation Center (Sichuan Provincial Rehabilitation Hospital), Chengdu 611135, China.'}, {'ForeName': 'Jian-Hui', 'Initials': 'JH', 'LastName': 'Gan', 'Affiliation': 'Department of Anesthesiology, The Affiliated Tangshan People Hospital of North China University of Science and Technology, Tangshan 06300, China.'}, {'ForeName': 'Jian-Bo', 'Initials': 'JB', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Sichuan 81 Rehabilitation Center (Sichuan Provincial Rehabilitation Hospital), Chengdu 611135, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, Sichuan 81 Rehabilitation Center (Sichuan Provincial Rehabilitation Hospital), Chengdu 611135, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2017.11.007']
1928,29551948,Application of fast track surgery in routine nursing for patient with colorectal cancer.,"Objective : To investigate the clinical effect of fast track surgery (FTS) in perioperative nursing of colorectal cancer surgery.  Background : In recent years, many complicated surgery began to develop in the direction of low invasion and short hospital time, which provides an unprecedented opportunity for the development of fast track surgery (FTS).  Methods : According to different nursing measures, 156 cases of colorectal cancer patients treated in our hospital were divided into FTS nursing group (86 cases) and traditional nursing group (70 cases). FTS nursing care and traditional nursing care were respectively employed to analyze and compare postoperative recovery and complications of the two groups.  Results : FTS nursing group was significantly shorter than the traditional care group in terms of the first postoperative exhaust time, the first defecation time, the first eating time, ambulation time and postoperative hospital time, with statistical significance ( P  < .05); compared with the conventional nursing group, FTS group significantly had lower incidence of postoperative intestinal obstruction, lower limb vein thrombus formation and gastrointestinal discomfort, with statistical significance ( P  < .05); FTS group has less situations of nausea and vomiting, incision infection, pulmonary infection, urinary tract infection and anastomotic leakage compared to the conventional nursing group.  Conclusion : FTS nursing can effectively promote the postoperative recovery of intestinal function for patients with colorectal cancer and reduce the occurrence of postoperative complications, which will relieve postoperative pain and shorten the length of stay, giving patients increased rehabilitation quality.",2017,"FTS nursing group was significantly shorter than the traditional care group in terms of the first postoperative exhaust time, the first defecation time, the first eating time, ambulation time and postoperative hospital time, with statistical significance ( P  < .05); compared with the conventional nursing group, FTS group significantly had lower incidence of postoperative intestinal obstruction, lower limb vein thrombus formation and gastrointestinal discomfort, with statistical significance ( P  < .05); FTS group has less situations of nausea and vomiting, incision infection, pulmonary infection, urinary tract infection and anastomotic leakage compared to the conventional nursing group.  ","['patients with colorectal cancer', 'patient with colorectal cancer', '156 cases of colorectal cancer patients treated in our hospital were divided into']","['FTS nursing group (86 cases) and traditional nursing group', 'fast track surgery', 'fast track surgery (FTS']","['nausea and vomiting, incision infection, pulmonary infection, urinary tract infection and anastomotic leakage', 'postoperative intestinal obstruction, lower limb vein thrombus formation and gastrointestinal discomfort', 'postoperative exhaust time, the first defecation time, the first eating time, ambulation time and postoperative hospital time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}]","[{'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0494809', 'cui_str': 'Postoperative intestinal obstruction (disorder)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0231226', 'cui_str': 'Exhausting (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",,0.0157706,"FTS nursing group was significantly shorter than the traditional care group in terms of the first postoperative exhaust time, the first defecation time, the first eating time, ambulation time and postoperative hospital time, with statistical significance ( P  < .05); compared with the conventional nursing group, FTS group significantly had lower incidence of postoperative intestinal obstruction, lower limb vein thrombus formation and gastrointestinal discomfort, with statistical significance ( P  < .05); FTS group has less situations of nausea and vomiting, incision infection, pulmonary infection, urinary tract infection and anastomotic leakage compared to the conventional nursing group.  ","[{'ForeName': 'Yongrui', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Nursing Department, People's Hospital of Zhengzhou, Zhengzhou, Henan Province, China.""}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2017.11.045']
1929,31635890,Riluzole Oral Suspension: Bioavailability Following Percutaneous Gastrostomy Tube-modeled Administration Versus Direct Oral Administration.,"PURPOSE


During amyotrophic lateral sclerosis progression, up to 85% of patients develop dysphagia. Riluzole oral suspension 50 mg/10 mL is bioequivalent to riluzole 50-mg film-coated tablets administered orally under fasting conditions. Here, we compare the bioavailability of a single 50-mg dose of riluzole oral suspension via intragastric tube, a proxy for percutaneous endoscopic gastrostomy administration, with that of oral administration in healthy volunteers under fasting conditions. Secondary objectives included the plasma pharmacokinetic and safety profiles of each administration route.
METHODS


This was a single-center, single-dose, open-label, randomized, 2-period, 2-sequence, crossover bioequivalence/bioavailability study. Healthy volunteers were randomized to riluzole oral suspension 50 mg/10 mL either via nasogastric tube or orally, with a 5-day washout before crossover.
FINDINGS


A total of 32 subjects were randomized (safety population); 30 were eligible for pharmacokinetic analysis. The ratios (nasogastric tube/oral) of the geometric least squares means and the geometric 90% CIs of AUC 0-t , AUC 0-inf , and C max  were calculated to be 90.60% (85.66%-95.82%), 90.43% (85.47%-95.67%), and 96.99% (89.40%-105.23%), respectively, indicating bioequivalence. No significant differences in C max , T max , K el , and t 1/2el  between treatments were found. Overall, riluzole oral suspension was well tolerated. No deaths or other serious adverse events were reported.
IMPLICATIONS


In this study, riluzole oral suspension was bioequivalent when administered intragastrically and orally in healthy subjects under fasting conditions. Both administration methods were well tolerated. These results show that intragastric administration of riluzole oral suspension may provide an important formulation option in people with amyotrophic lateral sclerosis who have a percutaneous endoscopic gastrostomy tube.",2019,"No significant differences in C max , T max , K el , and t 1/2el  between treatments were found.","['people with amyotrophic lateral sclerosis who have a percutaneous endoscopic gastrostomy tube', 'Healthy volunteers', 'healthy volunteers under fasting conditions', '50 mg/10', '32 subjects were randomized (safety population); 30 were eligible for pharmacokinetic analysis', 'healthy subjects under fasting conditions']","['Riluzole', 'riluzole oral suspension', 'riluzole oral suspension 50 mg/10\xa0mL either via nasogastric tube', '2019;41:XXX-XXX', 'Riluzole oral suspension']","['tolerated', 'C max , T max , K el , and t 1/2el', 'plasma pharmacokinetic and safety profiles of each administration route', 'ratios (nasogastric tube/oral) of the geometric least squares means and the geometric 90% CIs of AUC 0-t , AUC 0-inf , and C max', 'No deaths or other serious adverse events']","[{'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C0176751', 'cui_str': 'Percutaneous endoscopic gastrostomy (procedure)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0991537', 'cui_str': 'Oral Suspension'}, {'cui': 'C0442474', 'cui_str': 'Via nasogastric tube (qualifier value)'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube, device (physical object)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",32.0,0.0501427,"No significant differences in C max , T max , K el , and t 1/2el  between treatments were found.","[{'ForeName': 'Benjamin Rix', 'Initials': 'BR', 'LastName': 'Brooks', 'Affiliation': 'Atrium Health Neurosciences Institute, Carolinas Medical Center, University of North Carolina School of Medicine-Charlotte Campus, Charlotte, NC, United States. Electronic address: benjamin.brooks@atriumhealth.org.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bettica', 'Affiliation': 'Italfarmaco SpA, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cazzaniga', 'Affiliation': 'Italfarmaco SpA, Milan, Italy.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.09.016']
1930,31633607,Population Pharmacokinetics of Levobupivacaine During Transversus Abdominis Plane Block in Children.,"BACKGROUND


Levobupivacaine is commonly used during transversus abdominis plane (TAP) block in pediatric patients. However, the dosing regimen is still empirical, and the pharmacokinetic properties of levobupivacaine are not considered. Here, the pharmacokinetics of levobupivacaine during an ultrasound-guided TAP block were evaluated to optimize dosing regimen, regarding the between-subject variability (BSV) and the volume of levobupivacaine injected.
METHOD


The clinical trial (prospective, randomized, double-blind study protocol) was conducted in 40 children aged 1-5 years, who were scheduled for inguinal surgery. Each patient received 0.4 mg/kg of levobupivacaine with a volume of local anesthesia solution adjusted to 0.2 mL/kg of 0.2% or 0.4 mL/kg of 0.1% levobupivacaine. Blood samples were collected at 5, 15, 20, 25, 30, 45, 60, and 75 minutes after the block injection. The population pharmacokinetic analysis was performed using the NONMEM software.
RESULTS


From the pharmacokinetic parameters obtained, median Cmax, tmax,, and area under the concentration versus time curve were 0.315 mg/L, 17 minutes, and 41 mg/L·min, respectively. BSV of clearance was explained by weight. At the dose regimen of 0.4 mg/kg, none of the infants showed signs of toxicity, but in 13 patients, TAP block failed. After analysis, BSV for absorption rate constant, distribution volume, and clearance were 81%, 47%, and 41%, respectively. Residual unexplained variability was estimated to be 14%.
CONCLUSIONS


For improved efficiency in the pediatric population, the dose of levobupivacaine should be greater than 0.4 mg/kg. Children's weight should be considered to anticipate any risk of toxicity.",2020,"median Cmax, tmax, and area under the concentration versus time curve were 0.315 mg/L, 17 min, and 41 mg/L. min, respectively.","['40 children aged 1 to 5 years, who were scheduled for inguinal surgery', 'pediatric patients', 'Children']","['levobupivacaine', 'Levobupivacaine']","['Blood samples', 'BSV for absorption rate constant, distribution volume, and clearance', 'signs of toxicity', 'Residual unexplained variability', 'median Cmax, tmax, and area under the concentration versus time curve']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",40.0,0.147215,"median Cmax, tmax, and area under the concentration versus time curve were 0.315 mg/L, 17 min, and 41 mg/L. min, respectively.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vincent', 'Affiliation': 'Department of Pharmacokinetics, School of Pharmacy, Montpellier University.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Mathieu', 'Affiliation': 'Department of Toxicology and Target Drug Monitoring, Montpellier University Hospital (CHU Lapeyronie).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Nolain', 'Affiliation': 'Department of Pharmacometrics, Sanofi.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Menacé', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Montpellier University Hospital (CHU Lapeyronie).'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Khier', 'Affiliation': 'Department of Pharmacokinetics, School of Pharmacy, Montpellier University.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000702']
1931,31629637,The efficacy of the TachoSil binding suturing technique in laparoscopic partial nephrectomy to prevent the development of pseudoaneurysm.,"OBJECTIVE


Our specific aim was to introduce the TachoSil binding suturing technique for renal cell carcinoma (RCC) patients when closing the parenchymal defect after tumor excision during laparoscopic partial nephrectomy (LPN), which is a novel technique for reducing the risk of developing subsequent pseudoaneurysm (PA).
METHODS


We identified 113 pT1aN0M0 RCC patients who underwent LPN at our institution. Eighty-one (72%) patients underwent the suturing procedure without binding TachoSil, whereas 32 (28%) patients underwent renorraphy with the renal defect closed together with TachoSil. The vascular complications were evaluated by computed tomography or magnetic resonance imaging with enhanced contrast material at the first visit after LPN. We conducted Fischer's exact test to determine risk factors for transcatheter arterial embolization (TAE).
RESULTS


The median age was 55 (36-86) years old and the median follow-up time was 65 (12-147) months. In the overall population, there were 11 (11%) patients who underwent TAE because they developed PA. All 11 patients exhibited the imaging findings of PA, and were all from the conventional suturing group. In contrast, no patients for whom the TachoSil binding method was used had any significant findings on imaging (14% vs. 0%). Based on the analysis to determine risk factors for TAE due to PA development, the TachoSil binding suturing technique was one of the significant indicators for reducing the risk of developing PA.
CONCLUSIONS


Our study demonstrated that the TachoSil binding suturing technique might reduce the development of PA after LPN. Prospective randomized study and comparison to the standard 2 or 3-layer renorrhaphy is needed to prove its actual value.",2020,The vascular complications were evaluated by computed tomography or magnetic resonance imaging with enhanced contrast material at the first visit after LPN.,"['The median age was 55 (36-86) years old and the median follow-up time was 65 (12-147) months', '113 pT1aN0M0 RCC patients who underwent LPN at our institution', 'renal cell carcinoma (RCC) patients']","['TachoSil', 'TachoSil binding suturing technique', 'laparoscopic partial nephrectomy (LPN', 'transcatheter arterial embolization (TAE', 'suturing procedure without binding TachoSil']",['vascular complications'],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}]","[{'cui': 'C1871272', 'cui_str': 'TachoSil'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0038968', 'cui_str': 'Suture Technics'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial excision of kidney'}, {'cui': 'C1142192', 'cui_str': 'Transcatheter arterial embolization'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.0396002,The vascular complications were evaluated by computed tomography or magnetic resonance imaging with enhanced contrast material at the first visit after LPN.,"[{'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Shigeta', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan. Electronic address: kazz_matsumoto@yahoo.co.jp.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Preventive Medicine and Public Health, Biostatistics Unit at the Clinical Translational Research Center, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Akari', 'Initials': 'A', 'LastName': 'Komatsuda', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Takeda', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Mizuno', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Asanuma', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Arita', 'Affiliation': 'Department of Diagnostic Radiology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Akita', 'Affiliation': 'Department of Diagnostic Radiology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Jinzaki', 'Affiliation': 'Department of Diagnostic Radiology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Miyajima', 'Affiliation': 'Department of Urology, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Oya', 'Affiliation': 'Department of Urology, Keio University School of Medicine, Tokyo, Japan.'}]",Asian journal of surgery,['10.1016/j.asjsur.2019.09.002']
1932,32411260,"Cromolyn, a New Hope for Limited Treatment of Neutrophilic Asthma: a Phase II Randomized Clinical Trial.","Background


In this study, we aimed to determine the effects of cromolyn on the clinical outcomes and neutrophilic inflammation in patients with resistant cough-variant asthma.
Materials and Methods


Patients with cough-variant asthma, with normal physical examination and spirometry results, were treated by inhaled corticosteroids, antileukotrienes, antibiotics, and proton-pump inhibitors according to the Global Initiative for Asthma (GINA) guidelines. Seventy patients, who were resistant to these treatments, were enrolled in this double-blind randomized clinical trial. After randomization, eligible subjects received a cromolyn metered dose inhaler (MDI) or a placebo MDI, which was completely similar in appearance to the cromolyn inhaler. The primary outcomes included cough and Asthma Control Test (ACT) score.
Results


Based on the findings, cough significantly decreased with cromolyn therapy, compared to the placebo group. Other clinical findings, including dyspnea, sputum production, and nocturnal symptoms, also improved. The ACT score significantly improved to a nearly normal level (23.53±2.25) in the cromolyn group. Moreover, fractional exhaled nitric oxide (FeNO) significantly decreased with cromolyn treatment (14±9.31 ppm after treatment vs. 28.88±27.39 before treatment). The neutrophil count significantly decreased in the cromolyn group (from 44±24.2% before the trial to 34.08±16.7% after the trial), while it increased in the placebo group (from 39.67±26.47% to 56.71±27.22%).
Conclusion


Cromolyn improved the clinical findings of resistant cough-variant asthma and could suppress neutrophilic inflammation.",2019,The ACT score significantly improved to a nearly normal level (23.53±2.25) in the cromolyn group.,"['Seventy patients, who were resistant to these treatments', 'Patients with cough-variant asthma, with normal physical examination and spirometry results', 'Neutrophilic Asthma', 'patients with resistant cough-variant asthma']","['cromolyn metered dose inhaler (MDI) or a placebo MDI', 'cromolyn', 'inhaled corticosteroids, antileukotrienes, antibiotics, and proton-pump inhibitors according to the Global Initiative for Asthma (GINA) guidelines', 'placebo']","['neutrophil count', 'fractional exhaled nitric oxide (FeNO', 'dyspnea, sputum production, and nocturnal symptoms', 'ACT score', 'cough and Asthma Control Test (ACT) score']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0694548', 'cui_str': 'Cough variant asthma'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2363774', 'cui_str': 'Neutrophilic asthma'}]","[{'cui': 'C1967783', 'cui_str': 'Cromolyn Metered Dose Inhaler'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086073', 'cui_str': 'Cromolyn'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.306888,The ACT score significantly improved to a nearly normal level (23.53±2.25) in the cromolyn group.,"[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mirsadraee', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Islamic Azad University, Mashhad Branch, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sabbagh Sajadieh', 'Affiliation': 'Department of Internal Medicine, Golestan University of Medical Sciences, Sayyad Shirazi Hospital, Gorgan, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Ghafari', 'Affiliation': 'Shahid Hashemi Nezhad Research Center, Ministry of Education, Mashhad, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Tavakoli', 'Affiliation': 'Independent Pharmacist, Mashhad, Iran.'}, {'ForeName': 'Saeedeh', 'Initials': 'S', 'LastName': 'Sabbagh Sajadieh', 'Affiliation': 'Department of Pathology, Taleghani Medical Institute and Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Tanaffos,[]
1933,29464379,"Positive effects of fampridine on cognition, fatigue and depression in patients with multiple sclerosis over 2 years.","OBJECTIVE


To assess the effects of PR-fampridine on cognitive functioning, fatigue and depression in patients with multiple sclerosis (PwMS).
METHODS


Thirty-two PwMS were included in this trial. Cognitive performance was assessed in an open-label and randomized double-blind, placebo-controlled study design using a comprehensive neuropsychological test battery as well as questionnaires examining depression and fatigue.
RESULTS


We found significant improvements in cognitive measures assessing alertness (tonic alertness, p = 0.0244 and phasic alertness, p = 0.0428), psychomotor speed (p = 0.0140) as well as verbal fluency (p = 0.0002) during open-label treatment with PR-fampridine. These effects of performance were paralleled by patients' perception of reduced fatigue (physical, p = 0.0131; cognitive, p = 0.0225; total, p = 0.0126). Fampridine-induced improvements in phasic alertness (p = 0.0010) and measures of fatigue (physical, p = 0.0014; cognitive, p = 0.0003; total, p = 0.0005) were confirmed during randomized, double-blind, placebo-controlled assessment in the second year. In addition, we found positive effects of PR-fampridine on depressive symptoms (p = 0.0049). We demonstrated persisting beneficial effects of PR-fampridine on fatigue in PwMS over a period of more than 2 years. Drug responsiveness regarding cognitive performance and fatigue was not limited to walking responders.
CONCLUSIONS


Our data demonstrate significant positive effects of treatment with PR-fampridine over 2 years on different cognitive domains as well as fatigue and depression in a cohort of PwMS. These findings imply that PR-fampridine should be considered as symptomatic treatment improving aspects of cognition, fatigue and depression in PwMS.",2018,"Fampridine-induced improvements in phasic alertness (p = 0.0010) and measures of fatigue (physical, p = 0.0014; cognitive, p = 0.0003; total, p = 0.0005) were confirmed during randomized, double-blind, placebo-controlled assessment in the second year.","['patients with multiple sclerosis (PwMS', 'Thirty-two PwMS were included in this trial', 'patients with multiple sclerosis over 2\xa0years']","['PR-fampridine', 'placebo', 'fampridine']","['verbal fluency', 'cognition, fatigue and depression', 'fatigue and depression', 'phasic alertness', 'Cognitive performance', 'depressive symptoms', 'cognitive functioning, fatigue and depression', 'phasic alertness, p\xa0', 'psychomotor speed', 'cognitive measures assessing alertness (tonic alertness, p\xa0']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0000477', 'cui_str': 'fampridine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}]",32.0,0.0902612,"Fampridine-induced improvements in phasic alertness (p = 0.0010) and measures of fatigue (physical, p = 0.0014; cognitive, p = 0.0003; total, p = 0.0005) were confirmed during randomized, double-blind, placebo-controlled assessment in the second year.","[{'ForeName': 'Sarah D', 'Initials': 'SD', 'LastName': 'Broicher', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Frauenklinikstrasse 26, 8091, Zurich, Switzerland. SarahDinah.Broicher@uzh.ch.'}, {'ForeName': 'Linard', 'Initials': 'L', 'LastName': 'Filli', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Frauenklinikstrasse 26, 8091, Zurich, Switzerland.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Geisseler', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Frauenklinikstrasse 26, 8091, Zurich, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Germann', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Frauenklinikstrasse 26, 8091, Zurich, Switzerland.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Zörner', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Brugger', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Frauenklinikstrasse 26, 8091, Zurich, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Linnebank', 'Affiliation': 'Department of Neurology, Helios-Klinik Hagen-Ambrock, Ambrocker Weg 60, 58091, Hagen, Germany.'}]",Journal of neurology,['10.1007/s00415-018-8796-9']
1934,32411262,Assessment of the Effects of Inspiratory Muscle Training (IMT) and Aerobic Training on the Quality of Life of Patients with Chronic Obstructive Pulmonary Disease.,"Background


Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. The aim of this study was to investigate the effects of inspiratory muscle training (IMT) and aerobic exercise on health-related quality of life of patients with COPD.
Materials and Methods


This randomized controlled clinical trial was conducted on 60 patients with moderate to severe COPD, who were referred to Imam Hossein Hospital of Tehran, Iran in 2016. The patients were randomly assigned to four groups and treated for eight weeks. Group 1 (n=16) participated in 16 sessions of IMT (15 minutes per session), group 2 (n=14) performed aerobic exercises twice a week (40 minutes per session), group 3 (n=15) performed IMT and aerobic exercises, and group 4 (n=15) received no intervention, except for routine treatments (control). Quality of life was evaluated based on the Saint George's Respiratory Questionnaire (SGRQ) at baseline, week 4, and week 8 after the intervention.
Results


After eight weeks, all four groups experienced a significant improvement in their quality of life (P<0.05), and group 3 (IMT and aerobic exercise) showed the greatest improvement. However, quality of life improvement in group 4 (control) was less than the other three groups (P<0.05).
Conclusion


Aerobic exercise and IMT were more effective than routine protocols in improving the quality of life of COPD patients. Furthermore, short-term IMT plus aerobic exercise had the greatest impact on improving the health-related quality of life of COPD patients and could be used in the management of these patients.",2019,"After eight weeks, all four groups experienced a significant improvement in their quality of life (P<0.05), and group 3 (IMT and aerobic exercise) showed the greatest improvement.","['patients with COPD', '60 patients with moderate to severe COPD, who were referred to Imam Hossein Hospital of Tehran, Iran in 2016', '\n\n\nChronic obstructive pulmonary disease (COPD', 'Patients with Chronic Obstructive Pulmonary Disease']","['Inspiratory Muscle Training (IMT) and Aerobic Training', 'inspiratory muscle training (IMT) and aerobic exercise', 'IMT and aerobic exercises, and group 4 (n=15) received no intervention, except for routine treatments (control', 'Aerobic exercise and IMT', 'aerobic exercises', 'IMT']","['quality of life', 'Quality of Life', 'health-related quality of life', 'quality of life improvement', 'Quality of life', ""Saint George's Respiratory Questionnaire (SGRQ""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",60.0,0.0287239,"After eight weeks, all four groups experienced a significant improvement in their quality of life (P<0.05), and group 3 (IMT and aerobic exercise) showed the greatest improvement.","[{'ForeName': 'Amir Hossein', 'Initials': 'AH', 'LastName': 'Abedi Yekta', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehrshad', 'Initials': 'M', 'LastName': 'Poursaeid Esfahani', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Salehi', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hassabi', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Khosravi', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Kharabian', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Sohrabi', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Ali', 'Initials': 'AA', 'LastName': 'Mafi', 'Affiliation': 'Clinical Research Development Center of Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Rezaei', 'Affiliation': 'Department of Sports Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Tanaffos,[]
1935,31600833,Efficacy and safety of basic fibroblast growth factor (bFGF) related decapeptide solution plus Tacrolimus 0.1% ointment versus Tacrolimus 0.1% ointment in the treatment of stable vitiligo.,"Vitiligo is common acquired pigmentary disorder affecting skin of 1% of the world population, India 3% to 8% incidences approximately. Treatment is tough challenge. The combination treatments have proven beneficial due to different mechanisms. There is need to find drug targeting different mechanisms of action. Test medicine is decapeptide derived from basic Fibroblast Growth Factor (bFGF) treating vitiligo. The current study was to compare efficacy and safety of BFGF related decapeptide solution plus Tacrolimus 0.1% (M + T) Ointment versus Tacrolimus monotherapy 0.1% (T) Ointment in patients with stable vitiligo. The randomized, open label, comparative, prospective, multicentre study in patients with stable vitiligo was conducted. The primary endpoint was improvement in extent of repigmentation in target lesion after 12 months of treatment from baseline. The secondary endpoints were extent of repigmentation at end of 6 months, patient global assessment (PGA) and safety at end of 6 months. This shows interim analysis results. Total 94 patients were randomized to M + T (n = 40) and T (n = 44), 10 patients were lost to follow up. Extent of repigmentation (>50%) was significantly greater at end of 8 weeks in M + T group 22.5% (p ≤ .05) while 6.8% in T group. In grade of repigmentation, significant difference (p ≤ .05) was observed, M + T had better grade. PGA was significantly greater (p ≤ .05) in M + T-group than T. All these parameters showed significant improvement in M + T-group than group T at end of 6 months. No adverse events were reported during the study. It is an interim analysis report so complete data is not available for analysis. Addition of bFGF related decapeptide solution to Tacrolimus gave better results than Tacrolimus alone therapy. It also has a favorable safety profile and was well tolerated.",2019,Extent of Repigmentation (>50%) was significantly greater at end of 8 weeks in M+T group 22.5% (p ≤ 0.05) while 6.8% in T group.,"['patients with stable vitiligo was conducted', 'patients with stable vitiligo', 'Total 94 patients']","['Tacrolimus', 'monotherapy', 'bFGF (basic Fibroblast Growth Factor) related Decapeptide Solution plus Tacrolimus', 'BFGF related decapeptide solution plus Tacrolimus 0.1% (M+T) Ointment versus Tacrolimus', 'M+T']","['tolerated', 'adverse events', 'extent of repigmentation in target lesion', 'efficacy and safety', 'PGA', 'extent of repigmentation at end of 6 months, patient global assessment (PGA) and safety at end of 6 months', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0028912', 'cui_str': 'Salves'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",94.0,0.0737383,Extent of Repigmentation (>50%) was significantly greater at end of 8 weeks in M+T group 22.5% (p ≤ 0.05) while 6.8% in T group.,"[{'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Shah', 'Affiliation': 'Department of Dermatology, B.J. Medical College & Civil Hospital, Ahmedabad, India.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Godse', 'Affiliation': 'Department of Dermatology, D.Y. Patil Medical College, Navi Mumbai, India.'}, {'ForeName': 'Satyaprakash', 'Initials': 'S', 'LastName': 'Mahajan', 'Affiliation': 'Supe Hospital & Research Centre, Nashik, India.'}, {'ForeName': 'Sudhakarrao', 'Initials': 'S', 'LastName': 'Grandhi', 'Affiliation': 'Medipoint Hospital, Pune, India.'}, {'ForeName': 'Sonal', 'Initials': 'S', 'LastName': 'Shendkar', 'Affiliation': 'Lifepoint Multispecialty Hospital, Pune, India.'}, {'ForeName': 'Akhilesh', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Medical Services, Alkem Laboratories Ltd., India.'}, {'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Teli', 'Affiliation': 'Medical Services, Alkem Laboratories Ltd., India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Pathak', 'Affiliation': 'Medical Services, Alkem Laboratories Ltd., India.'}, {'ForeName': 'Davinder', 'Initials': 'D', 'LastName': 'Parsad', 'Affiliation': 'Department of Dermatology, Postgraduate Institute of Medical Education & Research, Chandigarh, India.'}]",Dermatologic therapy,['10.1111/dth.13109']
1936,31520741,Interim monitoring in a treatment strategy trial with a composite primary endpoint.,"When a clinical trial has a composite endpoint and a comparison of treatment strategies with multiple intervention components, interim data reviews by a data safety and monitoring board (DSMB) can be challenging as the data evolve on multiple fronts. We illustrate with a study in the treatment of Kaposi sarcoma (KS), an HIV-associated cancer with a multi-faceted disease presentation. The study, ACTG-A5264/AMC-067, was a 1:1 randomized trial to compare two strategies: immediate initiation of etoposide with antiretroviral therapy (ART), or ART with delayed etoposide upon disease progression. The outcome was a composite endpoint that included the following events, ordered from worst to best in the following three categories: (1) KS progression at 48 weeks, death, initiation of alternate KS treatment, loss to study follow-up; (2) stable KS; and (3) partial or complete KS response at 48 weeks. We present the interim results on the composite endpoint and the individual components, where components favored different study arms at an interim review. To facilitate interim data monitoring for complex trials, we recommend clear communications between the study team and the DSMB prior to the initiation of the trial on the need for a composite endpoint, the intentions behind the defined strategies, and relative importance of individual components of the composite endpoint. We also recommend flexibility in the timing of data reviews by the DSMB to interpret emerging data in multiple dimensions. Clinicaltrials.govNCT01352117.",2019,"To facilitate interim data monitoring for complex trials, we recommend clear communications between the study team and the DSMB prior to the initiation of the trial on the need for a composite endpoint, the intentions behind the defined strategies, and relative importance of individual components of the composite endpoint.","['Kaposi sarcoma (KS), an HIV-associated cancer with a multi-faceted disease presentation']","['etoposide with antiretroviral therapy (ART), or ART with delayed etoposide']","['KS progression at 48\u202fweeks, death, initiation of alternate KS treatment, loss to study follow-up; (2) stable KS; and (3) partial or complete KS response']","[{'cui': 'C0036220', 'cui_str': 'Kaposi Sarcoma'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}]","[{'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.0430354,"To facilitate interim data monitoring for complex trials, we recommend clear communications between the study team and the DSMB prior to the initiation of the trial on the need for a composite endpoint, the intentions behind the defined strategies, and relative importance of individual components of the composite endpoint.","[{'ForeName': 'Minhee', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA. Electronic address: mkang@hsph.harvard.edu.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Grund', 'Affiliation': 'School of Statistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunsberger', 'Affiliation': 'Biostatistics Research Branch, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Glidden', 'Affiliation': 'School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Volberding', 'Affiliation': 'School of Medicine, University of California, San Francisco, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105846']
1937,29492652,Cortico-spinal excitability and hand motor recovery in stroke: a longitudinal study.,"OBJECTIVE


To describe the relationship between changes of cortico-spinal excitability and motor recovery of the affected hand after stroke.
METHODS


Eighteen hemiparetic stroke patients with a severe-to-mild upper limb motor impairment were randomized. Cortico-spinal excitability measures (resting motor thresholds and motor evoked potentials) obtained from a distal (abductor pollicis brevis) and proximal (biceps brachii) upper limb muscle were assessed for both hemispheres. Motor function of the affected hand was tested by the Wolf Motor Function and Action Research Arm tests. The evaluations were performed at baseline and weekly over 7 weeks of in-patient neurological rehabilitation.
RESULTS


Severe hand dysfunction was associated with a strong suppression of ipsilesional cortico-spinal excitability and a shift of excitability towards the contralesional hemisphere. Mild hand impairment was associated with a shift of cortico-spinal excitability towards the ipsilesional hemisphere. Favorable motor recovery correlated with an increase of ipsilesional cortico-spinal excitability.",2018,Severe hand dysfunction was associated with a strong suppression of ipsilesional cortico-spinal excitability and a shift of excitability towards the contralesional hemisphere.,"['Eighteen hemiparetic stroke patients with a severe-to-mild upper limb motor impairment were randomized', 'stroke']",[],"['Motor function', 'ipsilesional cortico-spinal excitability']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",[],"[{'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}]",,0.0968158,Severe hand dysfunction was associated with a strong suppression of ipsilesional cortico-spinal excitability and a shift of excitability towards the contralesional hemisphere.,"[{'ForeName': 'Jitka', 'Initials': 'J', 'LastName': 'Veldema', 'Affiliation': 'Helios Klinik Kipfenberg, Konrad-Regler-Straße 1, 85110, Kipfenberg, Germany. jpodubec@post.cz.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Bösl', 'Affiliation': 'Helios Klinik Kipfenberg, Konrad-Regler-Straße 1, 85110, Kipfenberg, Germany.'}, {'ForeName': 'Dennis Alexander', 'Initials': 'DA', 'LastName': 'Nowak', 'Affiliation': 'Helios Klinik Kipfenberg, Konrad-Regler-Straße 1, 85110, Kipfenberg, Germany.'}]",Journal of neurology,['10.1007/s00415-018-8802-2']
1938,29428925,Adjuvant Therapy: YiqiDitanTongfu Decoction With External Diaphragm Pacer for Chronic Obstructive Pulmonary Disease Patients With Difficulty Weaning From Mechanical Ventilation.,"Context


Global morbidity from chronic obstructive pulmonary disease (COPD) is high worldwide. Diaphragm pacing (DP) can maintain the natural, negative pressure breathing of COPD patients with diaphragmatic muscle dysfunction. The YiqiDitanTongfu (YDTF) decoction has been used clinically with COPD patients to help them to wean from mechanical ventilation, with their ventilation functions being improved and the success rate of weaning being largely increased.
Objective


The study intended to investigate the combined therapeutic effects of external DP and the YDTF decoction for COPD patients who have had difficulty weaning from mechanical ventilation.
Design


This study was a retrospective cohort study.
Setting


The study occurred at the Hebei General Hospital and Hebei Province Chest Hospital (Hebei Province, Shijiazhuang, China).
Participants


Participants were 90 patients with COPD + type 1 respiratory failure, 101 patients with COPD + Type 2 respiratory failure, and 96 patients with COPD at the compensated stage.
Intervention


The participants were randomly divided into 3 groups: (1) traditional treatment (control group), (2) traditional treatment plus treatment with a diaphragm pacemaker (DP group), and (3) traditional treatment plus treatment with a DP and a YDTF decoction (DP + YDTF group). All treatments occurred for 12 d.
Outcome Measures


Relevant outcomes were measured and compared at baseline and postintervention, including the rapid shallow breathing index, tidal volume, maximum inspiratory pressure, degree of diaphragmatic muscle activity, maximum expiratory pressure, the successful rates of weaning from mechanical ventilation, the potential of hydrogen, the partial pressure of oxygen, partial pressure of carbon dioxide, and oxygen saturation.
Results


The patients treated with the DP plus the YDTF decoction were more successful in weaning from mechanical ventilation than those treated with DP. Of the patients with COPD + type 1 respiratory failure, 86.67% succeeded vs 70.00% of the DP patients. Of patients with COPD + type 2 respiratory failure, 87.88% succeeded vs 79.41% of the DP patients.
Conclusion


The DP plus the YDTF concoction acted as a successful treatment for heart failure caused by CPOD in comparison with the DP or YDTF alone, providing evidence that the DP + YDTF concoction can serve as a competitive method for helping COPD patients to wean from mechanical ventilation.",2020,"The DP plus the YDTF concoction acted as a successful treatment for heart failure caused by CPOD in comparison with the DP or YDTF alone, providing evidence that the DP + YDTF concoction can serve as a competitive method for helping COPD patients to wean from mechanical ventilation.","['Chronic Obstructive Pulmonary Disease Patients With Difficulty Weaning From Mechanical Ventilation', 'Hebei General Hospital and Hebei Province Chest Hospital (Hebei Province, Shijiazhuang, China', 'Participants were 90 patients with COPD + type 1 respiratory failure, 101 patients with COPD + Type 2 respiratory failure, and 96 patients with COPD at the compensated stage', 'Participants •', 'COPD patients who have had difficulty weaning from mechanical ventilation', 'COPD patients with diaphragmatic muscle dysfunction', 'chronic obstructive pulmonary disease (COPD']","['Adjuvant Therapy: YiqiDitanTongfu Decoction With External Diaphragm Pacer', 'Diaphragm pacing (DP', 'YDTF decoction', 'external DP and the YDTF decoction', 'traditional treatment (control group), (2) traditional treatment plus treatment with a diaphragm pacemaker (DP group), and (3) traditional treatment plus treatment with a DP and a YDTF decoction (DP + YDTF group', 'YiqiDitanTongfu (YDTF) decoction']","['Global morbidity', 'rapid shallow breathing index, tidal volume, maximum inspiratory pressure, degree of diaphragmatic muscle activity, maximum expiratory pressure, the successful rates of weaning from mechanical ventilation, the potential of hydrogen, the partial pressure of oxygen, partial pressure of carbon dioxide, and oxygen saturation']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia (disorder)'}, {'cui': 'C0398353', 'cui_str': 'Type II respiratory failure'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C1301400', 'cui_str': 'Diaphragm pacing'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0425488', 'cui_str': 'Rapid shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0232022', 'cui_str': 'Maximum expiratory pressure (observable entity)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]",101.0,0.0352537,"The DP plus the YDTF concoction acted as a successful treatment for heart failure caused by CPOD in comparison with the DP or YDTF alone, providing evidence that the DP + YDTF concoction can serve as a competitive method for helping COPD patients to wean from mechanical ventilation.","[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Quansheng', 'Initials': 'Q', 'LastName': 'Du', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Heling', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Long', 'Affiliation': ''}, {'ForeName': 'Xianlei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
1939,32411263,Moderate Aerobic Exercise Enhances the Th1/Th2 Ratio in Women with Asthma.,"Background


In this study, we aimed to investigate the effects of aerobic exercise training on the serum IL-4/IFN-γ ratio (Th1/Th2 balance), testosterone/cortisol ratio, levels of cortisol, testosterone, estrogen, and progesterone, and body mass index (BMI) and to determine the relationship between changes in these variables in women with asthma.
Materials and Methods


Twenty-one women with mild to moderate asthma and regular menstrual cycles were selected in this study. Eleven women in the exercise group participated in the aerobic exercise program (60 min/day, three days a week in the evening). Peripheral blood samples were collected before (week 0) and after (week 12) the program. The samples were analyzed to determine the levels of sex hormones and cortisol via chemiluminescence assay, and cytokines were examined by ELISA assay.
Results


The findings showed a significant increase in the Th1/Th2 ratio and a decrease in cortisol and BMI in the exercise group, compared to the control group (P<0.05). There was no significant correlation between changes in cortisol, sex hormones, and BMI and the increase in Th1/Th2 ratio.
Conclusion


The present results suggested that moderate aerobic exercise enhances the Th1/Th2 ratio, independent of changes in steroid hormone level and BMI in women with asthma.",2019,"The present results suggested that moderate aerobic exercise enhances the Th1/Th2 ratio, independent of changes in steroid hormone level and BMI in women with asthma.","['Women with Asthma', 'Eleven women in the exercise group participated in the', 'women with asthma', 'Materials and Methods\n\n\nTwenty-one women with mild to moderate asthma and regular menstrual cycles']","['aerobic exercise program', 'Moderate Aerobic Exercise', 'moderate aerobic exercise', 'aerobic exercise training']","['Th1/Th2 Ratio', 'IL-4/IFN-γ ratio (Th1/Th2 balance), testosterone/cortisol ratio, levels of cortisol, testosterone, estrogen, and progesterone, and body mass index (BMI', 'cortisol, sex hormones, and BMI and the increase in Th1/Th2 ratio', 'cortisol and BMI', 'Th1/Th2 ratio', 'Peripheral blood samples', 'levels of sex hormones and cortisol via chemiluminescence assay, and cytokines']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0201709', 'cui_str': 'Chemiluminescence assay'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",21.0,0.0202045,"The present results suggested that moderate aerobic exercise enhances the Th1/Th2 ratio, independent of changes in steroid hormone level and BMI in women with asthma.","[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Zarneshan', 'Affiliation': 'Department of Exercise Physiology, Azarbaijan Shahid Madani University, Tabriz, Iran.'}, {'ForeName': 'Mahdia', 'Initials': 'M', 'LastName': 'Gholamnejad', 'Affiliation': 'Department of Pulmonology, Urmia University of Medical Sciences, Urmia, Iran.'}]",Tanaffos,[]
1940,32411633,Mucopexy-Recto Anal Lifting (MuRAL) in managing obstructed defecation syndrome associated with prolapsed hemorrhoids and rectocele: preliminary results.,"Purpose


Treatment of rectocele associated with prolapsed hemorrhoids is a debated topic. Transanal stapling achieved good midterm results in patients with symptoms of obstructed defecation, nevertheless a number of severe complications have been reported. The aim of this study was to evaluate the safety and efficacy of a new endorectal manual technique in patients with obstructed defecation due to the combination of muco-hemorrhoidal prolapse and rectocele.
Methods


Patients enrolled after preoperative obstructed defecation syndrome (ODS) score, defecography and anoscopy were submitted to the novel Mucopexy-Recto Anal Lifting (MuRAL) combined with a modified Block procedure, and followed up by independent observers with digital exploration 3 weeks postoperatively, and digital exploration plus anoscopy at 3, 6, and 12 months. Operative time, hospital stay, numerating rating scale (NRS), ODS, satisfaction scores, and recurrence rate were recorded.
Results


Mean operative time was 35.7 minutes. Fifty-six patients completed 1-year follow-up: 7.1% had acute urinary retention, NRS score was < 3 from the third postoperative day, mean time of daily activity resumption was 12 days, none had persistent fecal urgency, 82% declared excellent/good satisfaction score, significant improvement of 6- and 12-month ODS score, no recurrence of rectocele, and 7.1% recurrence of prolapsed hemorrhoids were observed.
Conclusion


MuRAL associated with modified Block technique gave no severe complications and resulted in a safe and effective approach to symptomatic rectocele associated with muco-rectal prolapse. Further randomized studies, larger series, and longer follow-up are needed.",2020,"Fifty-six patients completed 1-year follow-up: 7.1% had acute urinary retention, NRS score was < 3 from the third postoperative day, mean time of daily activity resumption was 12 days, none had persistent fecal urgency, 82% declared excellent/good satisfaction score, significant improvement of 6- and 12-month ODS score, no recurrence of rectocele, and 7.1% recurrence of prolapsed hemorrhoids were observed.
","['patients with obstructed defecation due to the combination of muco-hemorrhoidal prolapse and rectocele', 'Patients enrolled after preoperative obstructed defecation syndrome (ODS) score, defecography and anoscopy were submitted to the']","['Mucopexy-Recto Anal Lifting (MuRAL', 'novel Mucopexy-Recto Anal Lifting (MuRAL) combined with a modified Block procedure, and followed up by independent observers with digital exploration 3 weeks postoperatively, and digital exploration plus anoscopy', 'new endorectal manual technique', 'Transanal stapling']","['Mean operative time', '6- and 12-month ODS score, no recurrence of rectocele, and 7.1% recurrence of prolapsed hemorrhoids', 'Operative time, hospital stay, numerating rating scale (NRS), ODS, satisfaction scores, and recurrence rate', 'acute urinary retention, NRS score', 'safety and efficacy', 'severe complications', 'persistent fecal urgency', 'mean time of daily activity resumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0149771', 'cui_str': 'Herniation of rectum into vagina'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0549186', 'cui_str': 'Obstructed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0524966', 'cui_str': 'Defecography'}, {'cui': 'C0193158', 'cui_str': 'Anoscopy'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0199220', 'cui_str': 'Digital palpation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0193158', 'cui_str': 'Anoscopy'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0185012', 'cui_str': 'Closure by staple'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549186', 'cui_str': 'Obstructed'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0149771', 'cui_str': 'Herniation of rectum into vagina'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0426636', 'cui_str': 'Urgent desire for stool'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.0444938,"Fifty-six patients completed 1-year follow-up: 7.1% had acute urinary retention, NRS score was < 3 from the third postoperative day, mean time of daily activity resumption was 12 days, none had persistent fecal urgency, 82% declared excellent/good satisfaction score, significant improvement of 6- and 12-month ODS score, no recurrence of rectocele, and 7.1% recurrence of prolapsed hemorrhoids were observed.
","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Pagano', 'Affiliation': 'General Surgery Unit, Vizzolo Predabissi Hospital, ASST Milano-Martesana, Vizzolo Predabissi (MI), Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Venturi', 'Affiliation': ""Day/Week Surgery Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Benegiamo', 'Affiliation': 'General Surgery Unit, Vizzolo Predabissi Hospital, ASST Milano-Martesana, Vizzolo Predabissi (MI), Italy.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Melada', 'Affiliation': ""Day/Week Surgery Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Contardo', 'Initials': 'C', 'LastName': 'Vergani', 'Affiliation': ""Day/Week Surgery Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",Annals of surgical treatment and research,['10.4174/astr.2020.98.5.277']
1941,31619358,Randomized Clinical Trial Comparing Femtosecond LASIK and Small-Incision Lenticule Extraction.,"PURPOSE


To compare femtosecond LASIK with small-incision lenticule extraction (SMILE) for the treatment of myopia and myopic astigmatism.
DESIGN


Prospective, randomized, paired-eye, single-masked clinical trial.
PARTICIPANTS


Consecutive eligible patients were randomized to undergo SMILE and LASIK in either eye at a single tertiary referral eye center.
METHODS


Patients were treated in each eye using the VisuMax (Carl Zeiss Meditec, Jena, Germany) 500-kHz femtosecond laser system. Excimer ablation was subsequently performed using the WaveLight EX500 excimer laser (Alcon Laboratories, Inc, Fort Worth, TX) in the eye for LASIK.
MAIN OUTCOME MEASURE


Refractive predictability at 3 months. Secondary outcomes were refractive outcomes, that is, efficacy and safety at 3 and 12 months.
RESULTS


We recruited 70 consecutive patients (mean age, 28±5 years; 64% women; all Asian) with no difference in preoperative spherical equivalent (SE) between eyes (-5.3±1.8 diopters [D] vs. -5.2±1.7 D; P = 0.87). At 3 months, 99% of SMILE eyes and 97% of LASIK eyes achieved SE within ±1.0 D of attempted correction (P = 1.0). Small-incision lenticule extraction achieved similar results as LASIK in terms of efficacy index (0.97±0.20 vs. 0.99±0.20; P = 0.56), uncorrected distance visual acuity (UDVA) of 20/40 or better (100% vs. 100%; P = 1.0), and UDVA of 20/20 or better (84% vs. 87%; P = 0.63). Safety index (1.1±0.2 vs. 1.1±0.2; P = 0.57) was similar between SMILE and LASIK eyes at 3 months. At 12 months, SMILE was similar to LASIK in terms of efficacy (85% vs. 83% UDVA ≥20/20; P = 0.81), predictability (99% vs. 99% ±1.0 D of attempted correction SE; P = 1.0), and safety (1.15±0.20 vs. 1.15±0.20; P = 0.93).
CONCLUSIONS


The results from this randomized trial suggest that SMILE produced promising refractive outcomes in terms of predictability, efficacy, and safety at 3 and 12 months of follow-up.",2020,Safety index (1.1±0.2 vs. 1.1±0.2; P = 0.57) was similar between SMILE and LASIK eyes at 3 months.,"['Consecutive eligible patients', 'Patients were treated in each eye using the', 'in either eye at a single tertiary referral eye center', '70 consecutive patients (mean age, 28±5 years; 64% women; all Asian) with no difference in preoperative spherical equivalent (SE) between eyes (-5.3±1.8 diopters [D] vs. -5.2±1.7 D; P\xa0= 0.87']","['VisuMax (Carl Zeiss Meditec, Jena, Germany) 500-kHz femtosecond laser system', 'Excimer ablation', 'Femtosecond LASIK and Small-Incision Lenticule Extraction', 'SMILE and LASIK', 'WaveLight EX500 excimer laser (Alcon Laboratories, Inc, Fort Worth, TX', 'SMILE', 'femtosecond LASIK with small-incision lenticule extraction (SMILE']","['refractive outcomes, that is, efficacy and safety', 'uncorrected distance visual acuity (UDVA', 'Safety index', 'predictability', 'predictability, efficacy, and safety', 'Refractive predictability', 'efficacy index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}]","[{'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0556965', 'cui_str': 'kilohertz'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0752094', 'cui_str': 'Laser-Assisted Stromal In Situ Keratomileusis'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}, {'cui': 'C0392265', 'cui_str': 'Lasers, Excimer'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",70.0,0.216313,Safety index (1.1±0.2 vs. 1.1±0.2; P = 0.57) was similar between SMILE and LASIK eyes at 3 months.,"[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ang', 'Affiliation': 'Cornea and Refractive Service, Singapore National Eye Centre, Singapore, Republic of Singapore; Singapore Eye Research Institute, Singapore, Republic of Singapore. Electronic address: marcus.ang@snec.com.sg.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Farook', 'Affiliation': 'Cornea and Refractive Service, Singapore National Eye Centre, Singapore, Republic of Singapore; Singapore Eye Research Institute, Singapore, Republic of Singapore.'}, {'ForeName': 'Hla M', 'Initials': 'HM', 'LastName': 'Htoon', 'Affiliation': 'Singapore Eye Research Institute, Singapore, Republic of Singapore; Department of Ophthalmology and Visual Science, Duke-NUS Graduate Medical School, Singapore, Republic of Singapore.'}, {'ForeName': 'Jodhbir S', 'Initials': 'JS', 'LastName': 'Mehta', 'Affiliation': 'Cornea and Refractive Service, Singapore National Eye Centre, Singapore, Republic of Singapore; Singapore Eye Research Institute, Singapore, Republic of Singapore; Department of Ophthalmology and Visual Science, Duke-NUS Graduate Medical School, Singapore, Republic of Singapore.'}]",Ophthalmology,['10.1016/j.ophtha.2019.09.006']
1942,32411301,Angiographic Restenosis in Coronary Bifurcations Treatment with Regular Drug Eluting Stents and Dedicated Bifurcation Drug-Eluting BiOSS Stents: Analysis Based on Randomized POLBOS I and POLBOS II Studies.,"Aim


The marked variation in bifurcation anatomy has brought about an ongoing search for stents specifically constructed for coronary bifurcations. This study aimed to analyze the angiographic restenosis prevalence and patterns and predictors of different patterns in dedicated bifurcation BiOSS® vs. current generation drug-eluting stents implanted in coronary bifurcation lesions based on data from two clinical trials POLBOS I and II.
Methods


Dedicated bifurcation BiOSS® stents were compared with drug-eluting stents (DES) in patients with stable coronary artery disease (CAD) or nonST elevation acute coronary syndrome (NSTE-ACS) (POLBOS I: paclitaxel eluting BiOSS® Expert vs. DES; POLBOS II: sirolimus eluting BiOSS® LIM vs. DES). Provisional T-stenting was the default treatment. Morphological pattern of in-stent restenosis according to the modified Mehran classification adopted for bifurcation lesions was assessed with bifurcation dedicated quantitative coronary angiographic software (CAAS 5.11, Pie Medical Imaging BV, the Netherlands).
Results


In total, 445 patients (222 patients in BiOSS group and 223 patients in DES group) were included into the analysis. In BiOSS group 24 cases of angiographic restenosis (10.8%) were recorded, and in DES group-17 cases (7.6%) at 12 months follow-up (angiographic control rate at follow-up-90.3%). In the BiOSS group most frequent medina classification in restenotic cases was 0.0.1 (25%), whereas in DES-0.0.1 and 0.1.1 (23.5% each). In multivariate regression analysis proximal optimization technique was associated with the lowest chance for restenosis (OR 0.15, 95% CI 0.06-0.33), whereas diabetes on insulin was associated with the highest risk of restenosis (OR 4.21, 95% CI 1.48-11.44).
Conclusions


The angiographic restenosis pattern and rate was similar between BiOSS stents and DES in coronary bifurcation lesions.",2020,"In multivariate regression analysis proximal optimization technique was associated with the lowest chance for restenosis (OR 0.15, 95% CI 0.06-0.33), whereas diabetes on insulin was associated with the highest risk of restenosis (OR 4.21, 95% CI 1.48-11.44).
","['445 patients (222 patients in BiOSS group and 223 patients in DES group) were included into the analysis', 'patients with stable coronary artery disease (CAD) or nonST elevation acute coronary syndrome (NSTE-ACS']","['Provisional T-stenting', 'drug-eluting stents (DES', '® stents', 'Regular Drug Eluting Stents and Dedicated Bifurcation Drug-Eluting BiOSS Stents']","['angiographic restenosis', 'angiographic restenosis pattern and rate', 'highest risk of restenosis', 'Angiographic Restenosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]",445.0,0.027815,"In multivariate regression analysis proximal optimization technique was associated with the lowest chance for restenosis (OR 0.15, 95% CI 0.06-0.33), whereas diabetes on insulin was associated with the highest risk of restenosis (OR 4.21, 95% CI 1.48-11.44).
","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gil', 'Affiliation': 'Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Bil', 'Affiliation': 'Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kern', 'Affiliation': 'Department of Cardiology and Cardiosurgery, University of Varmia and Masuria, Olsztyn, Poland.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Iñigo-Garcia', 'Affiliation': 'Costa del Sol Hospital, Marbella, Spain.'}, {'ForeName': 'Radoslaw', 'Initials': 'R', 'LastName': 'Formuszewicz', 'Affiliation': '10 Clinical Military Hospital, Bydgoszcz, Poland.'}, {'ForeName': 'Slawomir', 'Initials': 'S', 'LastName': 'Dobrzycki', 'Affiliation': 'Department of Invasive Cardiology, Medical University in Bialystok, Bialystok, Poland.'}, {'ForeName': 'Dobrin', 'Initials': 'D', 'LastName': 'Vassilev', 'Affiliation': 'Alexandrovska University Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Cardiovascular therapeutics,['10.1155/2020/6760205']
1943,32411381,Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial.,"Background


Depression impacts the lives of millions of people worldwide. Behavioral activation (BA), derived from cognitive behavioral therapy, has the potential for improving depressive symptoms in patients with depression. Studies evaluating the effectiveness of BA specifically in the context of group therapy programs in a hospital setting for patients with depression are limited. In this study, we report findings from a pilot trial evaluating group BA for major depressive disorder.
Objective


The objectives of this pilot trial are to assess the potential of a full trial of BA group therapy in a large-scale tertiary care setting and to provide preliminary information about possible results regarding mood symptoms and quality of life in adults with depression.
Methods


Using a parallel single-cohort pragmatic pilot randomized controlled trial design, we evaluated the potential of conducting a large trial of BA effectiveness among adults with depression. Participants were randomized to the intervention (BA in addition to usual care) or control (support group in addition to usual care) groups and were assessed weekly for 18 consecutive weeks. Participants randomized to intervention underwent 28 2-h group BA therapy visits administered by trained therapists and completed assessments to examine treatment outcomes. Feasibility was measured in terms of enrollment rates (min. 20%), completion rates of study (min. 80%), and completion rates of weekly measurement scales (min. 80%). The reporting of this pilot trial is in accordance with the CONSORT extension for randomized pilot and feasibility trials.
Results


We randomized 20 individuals of mean age of 48.8 years (standard deviation = 9.7) with a DSM-5 diagnosis of major depressive disorder to intervention ( n  = 10) or control ( n  = 10) groups. Based on our feasibility criteria, our recruitment rate was excellent (20/27; 74%), study completion was found to be a moderate (80% of the total participants in both arms completed the study; BA = 100%, control = 60%), and completeness of measurements on a weekly basis was adequate overall (82%; BA = 86%, control = 79%).
Conclusions


The study has demonstrated the potential feasibility to perform a larger scale trial upon modifications to the control group to avoid the low rate of study completion (60%) in this group.
Trial registration


ClinicalTrials NCT02045771, Registered January 22, 2014.",2020,"Behavioral activation (BA), derived from cognitive behavioral therapy, has the potential for improving depressive symptoms in patients with depression.","['patients with depression', 'adults with depression', '20 individuals of mean age of 48.8\u2009years (standard deviation\u2009=\u20099.7) with a DSM-5 diagnosis of major depressive disorder to intervention ( n \u2009=\u200910) or control ( n \u2009=\u200910) groups', 'patients with depression are limited']","['BA group therapy', 'behavioral activation group therapy', 'intervention (BA in addition to usual care) or control (support group in addition to usual care']","['Behavioral activation (BA', 'depressive symptoms and improving quality of life', 'completion rates of weekly measurement scales', 'mood symptoms and quality of life', 'Feasibility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0681887', 'cui_str': 'Measurement scales'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",20.0,0.127827,"Behavioral activation (BA), derived from cognitive behavioral therapy, has the potential for improving depressive symptoms in patients with depression.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': ""D'Elia"", 'Affiliation': '1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bawor', 'Affiliation': '1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.'}, {'ForeName': 'Brittany B', 'Initials': 'BB', 'LastName': 'Dennis', 'Affiliation': '2Population Genomics Program, Chanchlani Research Centre, McMaster University, 1280 Main St. W, Hamilton, ON Canada.'}, {'ForeName': 'Meha', 'Initials': 'M', 'LastName': 'Bhatt', 'Affiliation': '3Department of Health Research, Evidence and Impact, McMaster University, 1280 Main St. W, Hamilton, ON Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Litke', 'Affiliation': '2Population Genomics Program, Chanchlani Research Centre, McMaster University, 1280 Main St. W, Hamilton, ON Canada.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'McCabe', 'Affiliation': '1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Whattam', 'Affiliation': ""4Mood Disorders Program, St. Joseph's Healthcare Hamilton, 100 West 5th St, Hamilton, ON Canada.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Garrick', 'Affiliation': ""4Mood Disorders Program, St. Joseph's Healthcare Hamilton, 100 West 5th St, Hamilton, ON Canada.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': ""O'Neill"", 'Affiliation': '1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Simons', 'Affiliation': ""4Mood Disorders Program, St. Joseph's Healthcare Hamilton, 100 West 5th St, Hamilton, ON Canada.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Chalmers', 'Affiliation': ""4Mood Disorders Program, St. Joseph's Healthcare Hamilton, 100 West 5th St, Hamilton, ON Canada.""}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Key', 'Affiliation': '1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Goyert', 'Affiliation': ""4Mood Disorders Program, St. Joseph's Healthcare Hamilton, 100 West 5th St, Hamilton, ON Canada.""}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Laplante', 'Affiliation': '1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Vanstone', 'Affiliation': '3Department of Health Research, Evidence and Impact, McMaster University, 1280 Main St. W, Hamilton, ON Canada.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': '3Department of Health Research, Evidence and Impact, McMaster University, 1280 Main St. W, Hamilton, ON Canada.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Guyatt', 'Affiliation': '3Department of Health Research, Evidence and Impact, McMaster University, 1280 Main St. W, Hamilton, ON Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': '3Department of Health Research, Evidence and Impact, McMaster University, 1280 Main St. W, Hamilton, ON Canada.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Samaan', 'Affiliation': '1Department of Psychiatry and Behavioural Neuroscience, McMaster University, 100 West 5th Street, Hamilton, ON Canada.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00596-z']
1944,31609315,"A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition.","Limited evidence exists to precisely estimate efficacy and safety differences between parenteral nutrition (PN) prepared using olive-oil-based three-chamber bags (3CBs) and soybean-oil-based compounded bags (CoBs) in hospitalized adult patients. We designed a multicenter, randomized, prospective, open-label, noninferiority protocol to compare the efficacy, safety, and distribution of olive-oil-based 3CBs and soybean-oil-based CoB formulations in adult Chinese patients requiring PN during surgical intervention. Subjects were randomized to receive either one of the study treatments using an interactive voice or web-based recognition system in accordance with the randomization code. Randomization was further stratified based on the study site and surgical category. Both treatment groups received similar amounts of calories and protein. In addition, the two study treatments contained a similar composition of the amino-acid component. The only difference between the two PN formulations was the lipid constitution. The duration of administration of study treatments was a minimum of 5 days up to a maximum of 14 days after the surgical procedure. The primary efficacy endpoint was serum prealbumin levels on day 5 of the study. Noninferiority was proved if the anti-log of the lower bound of the 95% confidence interval (CI) of the treatment difference was at least 0.80. Other efficacy measures included treatment preparation time; duration to achieve tolerability of oral nutrition; associated infectious complications; length of hospitalization; and laboratory assessment of markers of nutrition, inflammation, metabolism, and oxidative stress. A total of 458 patients were enrolled in the study. The results showed that olive-oil-based 3CBs were non-inferior to soybean-based CoBs, besides being well tolerated. The infection rate was found to be significantly lower in the olive-oil-based 3CB group. Thus, this study may be used as a reference for future research on lipid emulsion and 3CBs.",2019,The infection rate was found to be significantly lower in the olive-oil-based 3CB group.,"['A total of 458 patients were enrolled in the study', 'hospitalized adult patients', 'adult Chinese patients requiring PN during surgical intervention']","['Olive-Oil-Based Three-Chamber Bags', 'olive-oil-based 3CBs', 'parenteral nutrition (PN) prepared using olive-oil-based three-chamber bags (3CBs) and soybean-oil-based compounded bags (CoBs', 'olive-oil-based 3CBs and soybean-oil-based CoB formulations', 'interactive voice or web-based recognition system']","['infection rate', 'tolerability of oral nutrition; associated infectious complications; length of hospitalization; and laboratory assessment of markers of nutrition, inflammation, metabolism, and oxidative stress', 'serum prealbumin levels']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}]","[{'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C1273508', 'cui_str': 'Serum prealbumin level'}]",458.0,0.0521304,The infection rate was found to be significantly lower in the olive-oil-based 3CB group.,"[{'ForeName': 'Zhenyi', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': ""Department of General Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of General Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital.""}, {'ForeName': 'Huanlong', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': ""Department of General Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital; Department of General Surgery, Shanghai Tenth People's Hospital Affiliated to Tongji University; hlqin65@163.com.""}]",Journal of visualized experiments : JoVE,['10.3791/57956']
1945,31580005,Immediate post-irradiation dermoscopic vascular changes versus purpura as a therapeutic endpoint in pulsed-dye laser treatment of port wine stains.,"Pulsed-dye laser (PDL) is the treatment of choice for port wine stain (PWS), and the development of purpura is considered a therapeutic endpoint. Changes in PWS vasculature observed by dermoscopy immediately after laser irradiation have been suggested to predict the minimal effective fluence. The current study aimed at comparing these changes with purpura as a therapeutic endpoint. Fifty-six PWS patients, randomized into two groups, received five monthly PDL sessions (595 nm and 10 mm spot size). At the first visit, patients received multiple gradually increasing test irradiations. Patients in the first group were treated with the lowest dose that resulted in 24-hr-lasting purpura, while patients in the second group were treated with the lowest dose that resulted in vessel disappearance observed by dermoscope. No statistically significant differences were observed between the two groups (the dermoscopic and the purpuric) regarding mean average improvement (42.4 and 37.32%, respectively, p = .32), grade of improvement (p = .44), and the rate of side effects (0 and 13.79%, respectively, p = .13). In conclusion, the immediate post-irradiation vessel disappearance (detected by dermoscope) is comparable, in safety and efficacy, to purpura as a therapeutic endpoint and maybe more time-saving and more accepted cosmetically.",2019,"No statistically significant differences were observed between the two groups (the dermoscopic and the purpuric) regarding mean average improvement (42.4 % and 37.32 % respectively, P = 0.32), grade of improvement (P = 0.44) and rate of side effects (0 % and 13.79 % respectively, P = 0.13).","['port wine stains', 'Fifty-six PWS patients']","['5 monthly PDL sessions', 'Pulsed dye laser (PDL']","['safety and efficacy', 'vessel disappearance', 'rate of side effects']","[{'cui': 'C0235752', 'cui_str': 'Nevus Flammeus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0392258', 'cui_str': 'Lasers, Tunable Dye'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0170303,"No statistically significant differences were observed between the two groups (the dermoscopic and the purpuric) regarding mean average improvement (42.4 % and 37.32 % respectively, P = 0.32), grade of improvement (P = 0.44) and rate of side effects (0 % and 13.79 % respectively, P = 0.13).","[{'ForeName': 'Azmy Ahmed', 'Initials': 'AA', 'LastName': 'Abdul Latif', 'Affiliation': 'Laser Unit, Department of Dermatology, Venereology and Andrology, Al-Azhar University Faculty of Medicine, Cairo, Egypt.'}, {'ForeName': 'Ahmad Kamel Seddeik', 'Initials': 'AKS', 'LastName': 'Abdel-Hameed', 'Affiliation': 'Laser Unit, Department of Dermatology, Venereology and Andrology, Al-Azhar University Faculty of Medicine, Cairo, Egypt.'}, {'ForeName': 'Omar Abdel Aziz Mohammad', 'Initials': 'OAAM', 'LastName': 'Salama', 'Affiliation': 'Laser Unit, Department of Dermatology, Venereology and Andrology, Al-Azhar University Faculty of Medicine, Cairo, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13094']
1946,32411343,Evaluation of Inflammatory Markers in Patients Undergoing a Short-Term Aerobic Exercise Program while Hospitalized due to Acute Exacerbation of COPD.,"Introduction


Acute exacerbation is an important factor for a worse prognosis in patients with chronic obstructive pulmonary disease (COPD). It promotes the increase of the inflammatory process and worsens quality of life, lung function, and muscle weakness. It is believed that physical exercise performed during the exacerbation breaks the vicious cycle of systemic manifestations without an increase in the inflammatory process.
Objective


To evaluate the influence of short-term aerobic physical exercise during hospitalization on inflammatory markers.  Patients and Methods . 26 patients were evaluated (69.2% female, FEV 137.5 ± 12.9%, and age 68.4 ± 11.6 years) 24 hours after hospitalization for smoking history, Charlson index, quality of life, systemic inflammatory markers, and body composition. After 48 hours of hospitalization, all patients underwent a 6-minute walk test (6MWT) and a new spirometry test, and BODE index was calculated. After 72 hours of hospitalization, patients in the intervention group underwent aerobic exercise on a treadmill for 15 minutes twice daily; before and after the aerobic exercise, blood samples were collected for evaluation of inflammatory markers. Finally, a month after hospital discharge, all patients were reevaluated according to systemic inflammatory markers, quality of life, body composition, spirometry, 6MWT, and BODE index.
Results


Patients of both groups did not differ in severity of disease and general characteristics. The intervention group did not show worsening in the inflammatory process after aerobic activity: TNF- α  from 1.19 (0 99-1.71) to 1.21 (0.77-1.53) ( p  = 0.58), IL-6 from 2.41 (2.02-0.58) to 2.66 (1.69-0.48) ( p  = 0.21), and CRP from 3.88 (2.26-8.04) to 4.07 (2.65-13.3) ( p  = 0.56). There was a negative correlation between the IL-6 marker and the 6MWT; that is, with the reduction in inflammatory levels, there was an improvement in exercise capacity one month after hospital discharge.
Conclusion


The present study showed that the aerobic physical activity initiated during hospitalization in patients with exacerbated COPD did not worsen the inflammatory process.",2020,"The intervention group did not show worsening in the inflammatory process after aerobic activity: TNF- α  from 1.19 (0 99-1.71) to 1.21 (0.77-1.53) ( p  = 0.58), IL-6 from 2.41 (2.02-0.58) to 2.66 (1.69-0.48) ( p  = 0.21), and CRP from 3.88 (2.26-8.04) to 4.07 (2.65-13.3) ( p  = 0.56).","['patients with chronic obstructive pulmonary disease (COPD', 'patients with exacerbated COPD', 'Patients Undergoing a Short-Term Aerobic Exercise Program while Hospitalized due to Acute Exacerbation of COPD', '26 patients were evaluated (69.2% female, FEV 137.5\u2009±\u200912.9%, and age 68.4\u2009±\u200911.6 years) 24 hours after hospitalization for smoking history, Charlson index, quality of life, systemic inflammatory markers, and body composition']","['short-term aerobic physical exercise', 'aerobic exercise']","['inflammatory levels', '6-minute walk test (6MWT) and a new spirometry test, and BODE index', 'inflammatory process and worsens quality of life, lung function, and muscle weakness', 'severity of disease and general characteristics', 'systemic inflammatory markers, quality of life, body composition, spirometry, 6MWT, and BODE index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",26.0,0.0394306,"The intervention group did not show worsening in the inflammatory process after aerobic activity: TNF- α  from 1.19 (0 99-1.71) to 1.21 (0.77-1.53) ( p  = 0.58), IL-6 from 2.41 (2.02-0.58) to 2.66 (1.69-0.48) ( p  = 0.21), and CRP from 3.88 (2.26-8.04) to 4.07 (2.65-13.3) ( p  = 0.56).","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Knaut', 'Affiliation': 'UNESP-Univ Estadual Paulista, Campus de Botucatu, Department of Internal Medicine, Pneumology Area, SP, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Bonfanti Mesquita', 'Affiliation': 'UNESP-Univ Estadual Paulista, Campus de Botucatu, Department of Internal Medicine, Pneumology Area, SP, Brazil.'}, {'ForeName': 'Victor Zuniga', 'Initials': 'VZ', 'LastName': 'Dourado', 'Affiliation': 'UNESP-Univ Estadual Paulista, Campus de Botucatu, Department of Internal Medicine, Pneumology Area, SP, Brazil.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'de Godoy', 'Affiliation': 'UNESP-Univ Estadual Paulista, Campus de Botucatu, Department of Internal Medicine, Pneumology Area, SP, Brazil.'}, {'ForeName': 'Suzana E', 'Initials': 'SE', 'LastName': 'Tanni', 'Affiliation': 'UNESP-Univ Estadual Paulista, Campus de Botucatu, Department of Internal Medicine, Pneumology Area, SP, Brazil.'}]",International journal of inflammation,['10.1155/2020/6492720']
1947,32411460,Laparoscopic Suture versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children: A Comparative Randomized Study.,"Purpose


To compare laparoscopic mesh rectopexy with laparoscopic suture rectopexy.  Patients and Methods . The prospective study was conducted at Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt between Feb 2010 and Jan 2015. Seventy-eight children with persistent complete rectal prolapse were subjected to laparoscopic rectopexy. Fourteen parents refused to participate. All patients received initial conservative treatment for more than one year. The remaining 64 patients were randomized divided into two equal groups. Group A; 32 patients underwent laparoscopic mesh rectopexy and group B, 32 underwent laparoscopic suture rectopexy. The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group.
Results


Sixty-four cases presented with persistent complete rectal prolapse were the material of this study. They were 40 males and 24 females. Mean age at operation was 8 (5-12) years. All cases were completed laparoscopically. Mean operative time in laparoscopic suture rectopexy was shorter than laparoscopic mesh rectopexy group. No early post-operative complications were encountered. No cases of recurrence with mesh rectopexy group while in suture rectopexy group it was 4 cases (14.2%). Post-operative constipation occurred in one case (3.57%) in suture rectopexy group and occurred in one case (3.3%) in mesh rectopexy group. Fecal incontinence improved in 26/28 cases (92.8%) in suture rectopexy while in mesh rectopexy it was improved in 30/30 cases (100%) of cases.
Conclusion


Both laparoscopic mesh and suture rectopexy are feasible and reliable methods for the treatment of complete rectal prolapse in children. However, no recurrence, low incidence of constipation and high improvement of incontinence at follow up more than 36 months with mesh rectopexy accordingly, we considered mesh rectopexy to be the procedure of choice in treatment of complete rectal prolapse.",2020,Both laparoscopic mesh and suture rectopexy are feasible and reliable methods for the treatment of complete rectal prolapse in children.,"['They were 40 males and 24 females', 'complete rectal prolapse in children', '64 patients', 'Persistent Complete Rectal Prolapse in Children', 'Fourteen parents refused to participate', 'Seventy-eight children with persistent complete rectal prolapse', 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt between Feb 2010 and Jan 2015']","['laparoscopic suture rectopexy', 'laparoscopic mesh rectopexy', 'laparoscopic mesh and suture rectopexy', 'laparoscopic rectopexy', 'initial conservative treatment', 'Laparoscopic Suture versus Mesh Rectopexy']","['persistent complete rectal prolapse', 'Mean operative time', 'no recurrence, low incidence of constipation and high improvement of incontinence', 'Post-operative constipation', 'operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence', 'Fecal incontinence']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0341399', 'cui_str': 'Complete rectal prolapse'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0193176', 'cui_str': 'Proctopexy'}, {'cui': 'C0400222', 'cui_str': 'Mesh rectopexy'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0341399', 'cui_str': 'Complete rectal prolapse'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",78.0,0.0386761,Both laparoscopic mesh and suture rectopexy are feasible and reliable methods for the treatment of complete rectal prolapse in children.,"[{'ForeName': 'AbdelAziz', 'Initials': 'A', 'LastName': 'Yehya', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Gamaan', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelrazek', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Shahin', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Seddek', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelhafez', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University Hospitals, Cairo, Egypt.'}]",Minimally invasive surgery,['10.1155/2020/3057528']
1948,30950165,"""It gave me so much confidence"": First-time U.S. mothers' experiences with antenatal milk expression.","Antenatal milk expression (AME) involves maternal hand-expression, collection, and storage of breast milk during pregnancy for the purposes of reducing the early formula use in breastfed infants. AME is not widely practiced in the United States, despite its growing popularity elsewhere. In this study, we examined the experiences of first-time mothers recruited from a U.S. midwife practice who engaged in AME within the context of a pilot randomized controlled trial. The AME intervention involved demonstration and practice of AME with a lactation consultant beginning at 37 weeks of gestation, reinforcement at weekly study visits until delivery, and daily home practice. Nineteen women participated in a semistructured interview at 1-2 weeks postpartum regarding their study experiences. Major themes included (1) perceived benefits and impact of AME, (b) AME implementation, and (c) use of AME milk. Women perceived multiple benefits of AME, most notably that it increased their confidence that they would be able to make milk and breastfeed successfully postpartum. Women expressed some concern that no/little milk expressed could be indicative of postpartum milk production problems. Regarding implementation, women found that the AME protocol fit well into their daily routine. There was mixed feedback regarding comfort with practicing AME in the presence of partners. Reasons for postpartum use of AME milk varied; barriers to provision included inadequate milk storage options at the birth hospital and unsupportive hospital providers/staff. With few caveats, AME appears to be an acceptable breastfeeding support intervention among a sociodemographically homogeneous group of first-time mothers in the United States.",2019,"With few caveats, AME appears to be an acceptable breastfeeding support intervention among a sociodemographically homogeneous group of first-time mothers in the United States.","['experiences of first-time mothers recruited from a U.S. midwife practice who engaged in AME within the context', 'breastfed infants', 'Nineteen women participated in a semistructured interview at 1-2\xa0weeks postpartum regarding their study experiences']",['AME'],"['Antenatal milk expression (AME) involves maternal hand-expression, collection, and storage of breast milk', 'benefits and impact of AME, (b) AME implementation, and (c) use of AME milk']","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",19.0,0.0380452,"With few caveats, AME appears to be an acceptable breastfeeding support intervention among a sociodemographically homogeneous group of first-time mothers in the United States.","[{'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Demirci', 'Affiliation': 'Department of Health Promotion & Development, University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Glasser', 'Affiliation': 'Department of Health Promotion & Development, University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fichner', 'Affiliation': ""Orthopedic, Neurosurgery, Neurology, and Trauma Unit, UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Caplan', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Katherine P', 'Initials': 'KP', 'LastName': 'Himes', 'Affiliation': 'Department of OBGYN and Reproductive Sciences, Division of Maternal-Fetal Medicine, University of Pittsburgh School of Medicine, UPMC Magee-Womens Hospital, Pittsburgh, Pennsylvania.'}]",Maternal & child nutrition,['10.1111/mcn.12824']
1949,31618520,Video education can improve awareness of risks for patients undergoing endoscopic retrograde cholangiopancreatography: A randomized trial.,"OBJECTIVE


We conducted a randomized trial aiming at improving patients' informed consent for undergoing endoscopic retrograde cholangiopancreatography (ERCP) in clinical care by comparing the efficacy of an additional educational video to written informed consent with that of written informed consent alone.
METHODS


This was a single-center, randomized controlled trial. Consecutive patients undergoing ERCP were randomized to a video education or a control group. An educational video detailing ERCP procedure plus standard written informed consent was administered to the video education group, while the control group reviewed standard written informed consent only. The primary outcome was the patients' perception of the risk or possibility of ERCP complications. Their perception of the benefits of ERCP, alternative treatments and overall satisfaction with the process of informed consent were also compared.
RESULTS


In total 205 patients were included in the study (104 in the control group and 101 in the video education group). Patients' comprehension of ERCP-related complications in the video education group was significantly increased (P < 0.001), and these patients were more likely to correctly identify the incidence of such complications. Significantly more patients in the video education group were very satisfied with informed consent process (87.1% vs 76.0%, P = 0.040) and fewer patients needed additional explanations (31.7% vs 47.1%, P = 0.024).
CONCLUSIONS


A supplementary educational video could greatly improve patient's understanding of ERCP procedure, in particular, its potential risks and complications, as well as their overall satisfaction with the process of informed consent (ClinicalTrials.gov no. NCT02810379).",2019,"The comprehension of ERCP complications in patients of video group was significantly improved (p < 0.001), and they were more likely to correctly identify the incidence of ERCP complications.","['Consecutive patients undergoing ERCP', 'Totally 205 patients were included in the study (104 in control group, 101 in video group', 'patients undergoing endoscopic retrograde cholangiopancreatography - a randomized trial']","['Video education', 'Endoscopic retrograde cholangiopancreatography (ERCP', 'video group or control group']","[""patients' perception of risk or possibility of ERCP complication"", 'comprehension of ERCP complications', 'awareness of risks']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",205.0,0.0707276,"The comprehension of ERCP complications in patients of video group was significantly improved (p < 0.001), and they were more likely to correctly identify the incidence of ERCP complications.","[{'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Xia', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yang Bei', 'Initials': 'YB', 'LastName': 'Zhu', 'Affiliation': ""Department of Gastroenterology, Shanghai Eighth People's Hospital, Shanghai, China.""}, {'ForeName': 'Yan Bo', 'Initials': 'YB', 'LastName': 'Zeng', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Shu Ling', 'Initials': 'SL', 'LastName': 'Wang', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Sheng Bing', 'Initials': 'SB', 'LastName': 'Zhao', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Xiao Ju', 'Initials': 'XJ', 'LastName': 'Su', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': ""Department of Gastroenterology, Jinan University of Second Clinical Medical Sciences, Shenzhen Municipal People's Hospital, Shenzhen, Guangdong Province, China.""}, {'ForeName': 'Zhao Shen', 'Initials': 'ZS', 'LastName': 'Li', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}]",Journal of digestive diseases,['10.1111/1751-2980.12824']
1950,31670874,Effectiveness of blood pressure-lowering treatment by the levels of baseline Framingham risk score: A post hoc analysis of the Systolic Blood Pressure Intervention Trial (SPRINT).,"This was a post hoc analysis of Systolic Blood Pressure Intervention Trial (SPRINT), aimed to investigate whether intensive blood pressure treatment has differential therapeutic outcomes on patients with different baseline Framingham risk score (FRS). The 9298 SPRINT participants were categorized into low-risk (baseline FRS < 10%), intermediate-risk (FRS = 10%-20%), or high-risk (FRS > 20%) arms. The primary outcome was a composite of myocardial infarction, acute coronary syndrome not resulting in myocardial infarction, stroke, acute decompensated heart failure, or death from cardiovascular causes. Serious adverse events were defined as hypotension, syncope, and bradycardia. Multiple Cox regression was used to calculate hazard ratios for study outcomes with intensive compared with standard SBP treatment between these three groups. After a median follow-up time of 3.26 years, the primary outcome hazard ratio (HR) for intensive versus standard treatment was 0.73 (95% CI: 0.61-0.88, P = .0044) in the high-risk arm. And, for all-cause mortality, the hazard ratio with intensive SBP treatment was 1.58 (95% CI: 0.55-1.06), 0.9 (95% CI: 0.26-9.50), and 0.53 (95% CI: 0.34-0.82) in three arms (all P values for interaction > 0.05). Effects of intensive versus standard SBP control on serious adverse events were similar among patients with different FRS. Our results suggested that regardless of the FRS level, the intensive blood pressure control was beneficial.",2019,Effects of intensive versus standard SBP control on serious adverse events were similar among patients with different FRS.,"['patients with different FRS', '9298 SPRINT participants were categorized into low-risk (baseline FRS', 'patients with different baseline Framingham risk score (FRS']","['intensive versus standard SBP control', 'blood pressure-lowering treatment', 'intensive blood pressure treatment']","['intermediate-risk', 'hypotension, syncope, and bradycardia', 'composite of myocardial infarction, acute coronary syndrome not resulting in myocardial infarction, stroke, acute decompensated heart failure, or death from cardiovascular causes', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.199312,Effects of intensive versus standard SBP control on serious adverse events were similar among patients with different FRS.,"[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Geriatrics, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xiuting', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Cardiology Department, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Lizhen', 'Initials': 'L', 'LastName': 'Liao', 'Affiliation': 'Guangzhou Higher Education Mega Center, Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Shaozhao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Cardiology Department, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Cardiology Department, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xiangbin', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': 'Cardiology Department, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhuang', 'Affiliation': 'Cardiology Department, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xinxue', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': 'Cardiology Department, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13720']
1951,32411374,Periodized resistance training for persistent non-specific low back pain: a mixed methods feasibility study.,"Background


We investigated the feasibility of a 16-week supervised heavy resistance training program with weekly undulating periodization for individuals with persistent non-specific low-back pain (LBP).
Methods


Twenty-five adults with persistent non-specific LBP participated in this mixed methods feasibility study. Participants trained a whole-body program consisting of squat, bench press, deadlift and pendlay row two times per week for 16 weeks. We assessed pain intensity, pain-related disability, pain self-efficacy and one-repetition maximum strength at baseline, 8 weeks and 16 weeks. Three focus group interviews were conducted at the end of the program. Linear mixed models were used to assess changes in outcomes, and the qualitative data was assessed using systematic text condensation.
Results


We observed clinically meaningful reductions in pain intensity after 8 and 16 weeks of training. The mean difference on the numeric pain rating scale (0-10) in the last 2 weeks from baseline to 8 weeks was 2.6 (95% CI: 1.8-3.6) and from baseline to 16 weeks 3.4 (95% CI: 2.5-4.4). In addition, there were improvements in pain-related disability (3.9, 95% CI: 2.3-5.5), pain self-efficacy (7.7, 95% CI: 5.4-10.1) and muscle strength. In the focus group interviews, participants talked about challenges regarding technique, the importance of supervision and the advantages of periodizing the training. Perceived benefits were improved pain, daily functioning, energy level and sleep, and changes in views on physical activity.
Conclusion


Periodized resistance training with weekly undulating periodization is a feasible training method for this group of individuals with persistent non-specific LBP. A randomized clinical trial should assess the efficacy of such an intervention.
Trial registration


clinicaltrials.gov   /  Identifier - NCT04284982, Registered on February 24th 2020.",2020,"In addition, there were improvements in pain-related disability (3.9, 95% CI: 2.3-5.5), pain self-efficacy (7.7, 95% CI: 5.4-10.1) and muscle strength.","['Methods\n\n\nTwenty-five adults with persistent non-specific LBP', 'individuals with persistent non-specific LBP', 'persistent non-specific low back pain', 'individuals with persistent non-specific low-back pain (LBP']","['Periodized resistance training', 'supervised heavy resistance training program']","['muscle strength', 'pain intensity', 'pain self-efficacy', 'pain, daily functioning, energy level and sleep, and changes in views on physical activity', 'pain intensity, pain-related disability, pain self-efficacy and one-repetition maximum strength', 'numeric pain rating scale', 'pain-related disability']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",25.0,0.159802,"In addition, there were improvements in pain-related disability (3.9, 95% CI: 2.3-5.5), pain self-efficacy (7.7, 95% CI: 5.4-10.1) and muscle strength.","[{'ForeName': 'Svein O', 'Initials': 'SO', 'LastName': 'Tjøsvoll', 'Affiliation': '1Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mork', 'Affiliation': '2Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Vegard M', 'Initials': 'VM', 'LastName': 'Iversen', 'Affiliation': '2Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Marit B', 'Initials': 'MB', 'LastName': 'Rise', 'Affiliation': '3Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Marius S', 'Initials': 'MS', 'LastName': 'Fimland', 'Affiliation': '1Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00181-0']
1952,32411551,"Impact of Simulation Training on Undergraduate Clinical Decision-making in Emergencies: A Non-blinded, Single-centre, Randomised Pilot Study.","Introduction There is an increasing evidence base for the use of simulation-based medical education. Simulation is superior to more didactic methods for teaching a range of technical and non-technical skills, and students report they often derive more educational value from it compared with other teaching methods. There is currently limited evidence that simulation training improves clinical decision-making and, therefore, this pilot study sought to explore this further. Methods Students were randomised to take part in either five classroom tutorials and simulation training sessions or five classroom tutorials and an online e-learning module. On completion of the teaching, students all undertook an unseen assessment scenario (managing a simulated patient with anaphylaxis), where they were scored using a weighted marking scheme. The time taken to make decisions and student-reported confidence in decisions were also measured. Results 14/14 simulation-group participants and 12/14 e-learning-group participants completed the post-learning assessment. The simulation group identified anaphylaxis and gave adrenaline more quickly (p 0.008 and 0.005, respectively), and this cohort was more confident in making the diagnosis (p 0.044). There was no statistically significant difference between weighted global assessment scores for each group (p 0.705). The e-learning group called for help more quickly (p.0.049), although fewer students in this group called for help (five vs. nine). There was no statistical difference in confidence in decisions to administer adrenaline or call for help (p 0.539 and 0.364 respectively). Conclusions Participants who undertook simulation training were able to more confidently and quickly identify the diagnosis and initiate emergency treatment. However, there was not a statistically significant difference between groups using an overall weighted score. Using simulation to train students to perform better in emergencies and improve their decision-making shows promise but a further quantitative study is required.",2020,Conclusions Participants who undertook simulation training were able to more confidently and quickly identify the diagnosis and initiate emergency treatment.,['Undergraduate Clinical Decision-making in Emergencies'],"['adrenaline', 'Simulation Training', 'five classroom tutorials and simulation training sessions\xa0or five classroom tutorials and an online e-learning module']",['weighted global assessment scores'],"[{'cui': 'C4042877', 'cui_str': 'Medical Decision-Making'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",,0.0581088,Conclusions Participants who undertook simulation training were able to more confidently and quickly identify the diagnosis and initiate emergency treatment.,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Everson', 'Affiliation': 'Emergency Medicine, School of Medicine, Anglia Ruskin University and Southend University Hospital, Chelmsford, GBR.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Gao', 'Affiliation': 'Emergency Medicine, School of Medicine, Anglia Ruskin University, Chelmsford, GBR.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Roder', 'Affiliation': 'Medical Education and Simulation, School of Medicine, Anglia Ruskin University, Chelmsford, GBR.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinnear', 'Affiliation': 'Internal Medicine: Critical Care, School of Medicine, Anglia Ruskin University, Chelmsford, GBR.'}]",Cureus,['10.7759/cureus.7650']
1953,29295652,Long-Lasting Neuropsychological Effects of a Computerized Cognitive Training in Patients Affected by Early Stage Alzheimer's Disease: Are They Stable Over Time?,"INTRODUCTION


We investigated the stability of effects of a computerized cognitive training previously administered to a large group of early stage Alzheimer's disease (AD) patients, as compared with a control group.
METHOD


Eighty AD patients were randomized in two groups and underwent a computerized cognitive training, or a control intervention.
RESULTS


A Repeated Measures General Linear Model (RM-GLM) showed a significant interaction effect for the following neuropsychological tests: the digit span forward and backward, and the two-syllable words test, as measures of short-term memory and working memory; the Rivermead Behavioural Memory Test (RBMT) story immediate and the RBMT story delayed, as measures of ecologically oriented memory; the Token test, as measure of language comprehension; and the Brixton test, as an executive functions measure.
CONCLUSION


Patients in the experimental group showed a significant improvement in various neuropsychological domains due to the training, and these effects decreased after 12 months.",2019,"Patients in the experimental group showed a significant improvement in various neuropsychological domains due to the training, and these effects decreased after 12 months.","[""large group of early stage Alzheimer's disease (AD) patients"", 'Eighty AD patients', ""Patients Affected by Early Stage Alzheimer's Disease""]","['Computerized Cognitive Training', 'computerized cognitive training', 'computerized cognitive training, or a control intervention']","['digit span forward and backward, and the two-syllable words test, as measures of short-term memory and working memory; the Rivermead Behavioural Memory Test (RBMT) story immediate and the RBMT story delayed, as measures of ecologically oriented memory; the Token test, as measure of language comprehension; and the Brixton test, as an executive functions measure', 'various neuropsychological domains']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0475507', 'cui_str': 'Rivermead Behavioural Memory Test'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0451545', 'cui_str': 'Token test (assessment scale)'}, {'cui': 'C0233733', 'cui_str': 'Language comprehension, function (observable entity)'}, {'cui': 'C0589093', 'cui_str': 'Brixton test (assessment scale)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",80.0,0.0448822,"Patients in the experimental group showed a significant improvement in various neuropsychological domains due to the training, and these effects decreased after 12 months.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cavallo', 'Affiliation': '1 eCampus University, Novedrate, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Angilletta', 'Affiliation': '2 Assisted Health Residence ""Ville Roddolo,"" Moncalieri, Italy.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464817750276']
1954,31482224,Population pharmacokinetics and exposure-overall survival analysis of the transforming growth factor-β inhibitor galunisertib in patients with pancreatic cancer.,"PURPOSE


To evaluate the exposure-overall survival (OS) relationship in patients with advanced pancreatic cancer treated with galunisertib plus gemcitabine (GG) or gemcitabine plus placebo (GP).
METHODS


Galunisertib 300 mg/day was given orally as intermittent dosing and gemcitabine as per label. Galunisertib exposure metrics for each patient in the GG arm (n = 99) of a phase 2 study of pancreatic cancer were calculated. Parametric survival models were used to identify influential baseline and response covariates on OS.
RESULTS


The population pharmacokinetics dataset included data from 297 patients/healthy subjects (age: 22-84 years, weight: 39-126 kg) across multiple studies, including this pancreatic cancer study. Galunisertib was rapidly absorbed with peak concentrations attained within 0.5-2 h and had an elimination half-life of 8 h. Between-subject variance on apparent clearance was estimated to be 47%. Age was the only characteristic to have a statistically significant effect on apparent clearance. A parametric Weibull survival model with treatment effect (dose) estimated a hazard ratio of 0.796, after adjusting for patient baseline factors that were significantly associated with OS. There was also a flat daily exposure-OS relationship within the observed exposure range, once all significant baseline covariates were included. Response covariates, such as reduction in CA19-9, time on treatment, and cumulative exposure over treatment cycles were also identified as significant factors for OS for patients with pancreatic cancer.
CONCLUSIONS


This analysis suggests that 300 mg/day galunisertib administered as 150 mg twice daily for 14 days on/14 days off treatment is an appropriate dosing regimen for patients with pancreatic cancer.",2019,Age was the only characteristic to have a statistically significant effect on apparent clearance.,"['297 patients/healthy subjects (age: 22-84\xa0years, weight: 39-126\xa0kg) across multiple studies, including this pancreatic cancer study', 'patients with advanced pancreatic cancer treated with', 'patients with pancreatic cancer']","['transforming growth factor-β inhibitor galunisertib', 'galunisertib plus gemcitabine (GG) or gemcitabine plus placebo (GP', 'gemcitabine']","['flat daily exposure-OS relationship', 'apparent clearance', 'CA19-9, time on treatment, and cumulative exposure', 'exposure-overall survival (OS) relationship']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0040691', 'cui_str': 'Animal growth regulators, transforming growth factors'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3896943'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205324', 'cui_str': 'Flat (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",297.0,0.0698035,Age was the only characteristic to have a statistically significant effect on apparent clearance.,"[{'ForeName': 'Ivelina', 'Initials': 'I', 'LastName': 'Gueorguieva', 'Affiliation': 'Global PK/PD, Eli Lilly and Company, Sunninghill Road, Erl Wood Manor, ROB building, Windlesham, Surrey, GU20 6PH, UK. gueorguieva_ivelina@lilly.com.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), IOB-Quiron, Barcelona, Spain.""}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Melisi', 'Affiliation': 'Digestive Molecular Clinical Oncology, University of Verona, Verona, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), IOB-Quiron, Barcelona, Spain.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Merz', 'Affiliation': 'Digestive Molecular Clinical Oncology, University of Verona, Verona, Italy.'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Waterhouse', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Miles', 'Affiliation': 'Global PK/PD, Eli Lilly and Company, Sunninghill Road, Erl Wood Manor, ROB building, Windlesham, Surrey, GU20 6PH, UK.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Lahn', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Cleverly', 'Affiliation': 'Global PK/PD, Eli Lilly and Company, Sunninghill Road, Erl Wood Manor, ROB building, Windlesham, Surrey, GU20 6PH, UK.'}, {'ForeName': 'Karim A', 'Initials': 'KA', 'LastName': 'Benhadji', 'Affiliation': 'Eli Lilly and Company, Bridgewater, NJ, USA.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03931-1']
1955,31610998,Differential treatment effects of an integrated motivational interviewing and exercise intervention on depressive symptom profiles and associated factors: A randomised controlled cross-over trial among youth with major depression.,"BACKGROUND


Exercise is increasingly recognised as an efficacious intervention for major depressive disorder (MDD) but to our knowledge differential treatment effects on depressive symptom profiles (cognitive, somatic and affective) and associated changes in psychological, physiological and behavioural factors have not been examined among youth with MDD.
METHODS


Sixty-eight participants (mean age 20.8) meeting DSM-IV diagnostic criteria for MDD were randomised to an Immediate intervention or Control/delayed condition (n = 34 per group). The integrated intervention comprised an initial session of motivational interviewing (MI) followed by a 12-week, multi-modal exercise program. Changes in depressive symptom profiles were assessed with the Beck Depression Inventory-II (BDI-II) total score and factorial symptom subscales.
RESULTS


There were significant differential improvements in BDI-II total scores post-treatment among intervention participants, which were also observed across the cognitive and affective subscales. Individual BDI-II items from the cognitive subscale showing significant differential improvement related to negative self-concept, while those from the affective subscale related to interest/activation; the energy item within the somatic subscale also revealed significant differential improvement. Significant differential improvements were also observed in exercise participation, negative automatic thoughts, behavioural activation and bench press repetitions among intervention participants, which correlated significantly with depression improvements.
LIMITATIONS


The exercise intervention was delivered in a supervised, group format and potential social meditators of change cannot be excluded.
CONCLUSIONS


Exercise differentially effects depressive symptom profiles with similar antidepressant effects as would be expected from psychological therapies improving negative cognition and emotional health.",2019,"Significant differential improvements were also observed in exercise participation, negative automatic thoughts, behavioural activation and bench press repetitions among intervention participants, which correlated significantly with depression improvements.
","['Sixty-eight participants (mean age 20.8) meeting DSM-IV diagnostic criteria for MDD', 'major depressive disorder (MDD', 'youth with major depression']","['Immediate intervention or Control/delayed condition', 'integrated intervention comprised an initial session of motivational interviewing (MI) followed by a 12-week, multi-modal exercise program', 'integrated motivational interviewing and exercise intervention', 'exercise intervention']","['negative cognition and emotional health', 'exercise participation, negative automatic thoughts, behavioural activation and bench press repetitions', 'depressive symptom profiles and associated factors', 'cognitive and affective subscales', 'Beck Depression Inventory-II (BDI-II) total score and factorial symptom subscales', 'BDI-II total scores', 'depressive symptom profiles']","[{'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0424004', 'cui_str': 'Negative automatic thoughts (finding)'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",68.0,0.012155,"Significant differential improvements were also observed in exercise participation, negative automatic thoughts, behavioural activation and bench press repetitions among intervention participants, which correlated significantly with depression improvements.
","[{'ForeName': 'Yasmina', 'Initials': 'Y', 'LastName': 'Nasstasia', 'Affiliation': 'School of Psychology, University of Newcastle, Callaghan, NSW 2308, Australia. Electronic address: yasmina.nasstasia@newcastle.edu.au.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Baker', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Terry J', 'Initials': 'TJ', 'LastName': 'Lewin', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Halpin', 'Affiliation': 'School of Psychology, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'School of Psychology, University of Queensland, St Lucia, QLD 4072, Australia.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Kelly', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Callister', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW 2308, Australia.'}]",Journal of affective disorders,['10.1016/j.jad.2019.08.035']
1956,31619250,Assessing the Integrated Community-Based Health Systems Strengthening initiative in northern Togo: a pragmatic effectiveness-implementation study protocol.,"BACKGROUND


Over the past decade, prevalence of maternal and child morbidity and mortality in Togo, particularly in the northern regions, has remained high despite global progress. The causes of under-five child mortality in Togo are diseases with effective and low-cost prevention and/or treatment strategies, including malaria, acute lower respiratory infections, and diarrheal diseases. While Togo has a national strategy for implementing the integrated management of childhood illness (IMCI) guidelines, including a policy on integrated community case management (iCCM), challenges in implementation and low public sector health service utilization persist. There are critical gaps to access and quality of community health systems throughout the country. An integrated facility- and community-based initiative, the Integrated Community-Based Health Systems Strengthening (ICBHSS) initiative, seeks to address these gaps while strengthening the public sector health system in northern Togo. This study aims to evaluate the effect and implementation strategy of the ICBHSS initiative over 48 months in the catchment areas of 21 public sector health facilities.
METHODS


The ICBHSS model comprises a bundle of evidence-based interventions targeting children under five, women of reproductive age, and people living with HIV through (1) community engagement and feedback; (2) elimination of point-of-care costs; (3) proactive community-based IMCI using community health workers (CHWs) with additional services including family planning, HIV testing, and referrals; (4) clinical mentoring and enhanced supervision; and (5) improved supply chain management and facility structures. Using a pragmatic type II hybrid effectiveness-implementation study, we will evaluate the ICBHSS initiative with two primary aims: (1) determine effectiveness through changes in under-five mortality rates and (2) assess the implementation strategy through measures of reach, adoption, implementation, and maintenance. We will conduct a mixed-methods assessment using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. This assessment consists of four components: (1) a stepped-wedge cluster randomized control trial using a community-based household survey, (2) annual health facility assessments, (3) key informant interviews, and (4) costing and return-on-investment assessments for each randomized cluster.
DISCUSSION


Our research is expected to contribute to continuous quality improvement initiatives, optimize implementation factors, provide knowledge regarding health service delivery, and accelerate health systems improvements in Togo and more broadly.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT03694366 , registered 3 October 2018.",2019,"An integrated facility- and community-based initiative, the Integrated Community-Based Health Systems Strengthening (ICBHSS) initiative, seeks to address these gaps while strengthening the public sector health system in northern Togo.","['over 48\u2009months in the catchment areas of 21 public sector health facilities', 'northern Togo']","['community-based household survey, (2) annual health facility assessments, (3) key informant interviews, and (4) costing and return-on-investment assessments', 'Integrated Community-Based Health Systems Strengthening initiative', 'proactive community-based IMCI using community health workers (CHWs) with additional services including family planning, HIV testing, and referrals; (4) clinical mentoring and enhanced supervision; and (5) improved supply chain management and facility structures', 'ICBHSS initiative']",[],"[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0007403', 'cui_str': 'Health Service Area'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0040363', 'cui_str': 'Togolese Republic'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0021953', 'cui_str': 'Investments'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009861', 'cui_str': 'Family Planning Services'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4255266', 'cui_str': 'Mentoring'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]",[],21.0,0.057075,"An integrated facility- and community-based initiative, the Integrated Community-Based Health Systems Strengthening (ICBHSS) initiative, seeks to address these gaps while strengthening the public sector health system in northern Togo.","[{'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Lauria', 'Affiliation': 'Community Health Systems Lab, Integrate Health/Santé Intégrée, Kara, Togo. mlauria@integratehealth.org.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Fiori', 'Affiliation': 'Community Health Systems Lab, Integrate Health/Santé Intégrée, Kara, Togo.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'CUNY Graduate School of Public Health & Health Policy, New York, USA.'}, {'ForeName': 'Sesso', 'Initials': 'S', 'LastName': 'Gbeleou', 'Affiliation': 'Integrate Health/Santé Intégrée, Kara, Togo.'}, {'ForeName': 'Komlan', 'Initials': 'K', 'LastName': 'Kenkou', 'Affiliation': 'Integrate Health/Santé Intégrée, Kara, Togo.'}, {'ForeName': 'Sibabe', 'Initials': 'S', 'LastName': 'Agoro', 'Affiliation': 'Kara Regional Health Department, Ministry of Health and Public Hygiene, Kara, Togo.'}, {'ForeName': 'Abdourahmane Diparidé', 'Initials': 'AD', 'LastName': 'Agbèrè', 'Affiliation': 'Department of Pediatrics, Health Sciences Faculty, University of Lomé, Lomé, Togo.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Lue', 'Affiliation': 'Community Health Systems Lab, Integrate Health/Santé Intégrée, Kara, Togo.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Hirschhorn', 'Affiliation': 'Community Health Systems Lab, Integrate Health/Santé Intégrée, Kara, Togo.'}]",Implementation science : IS,['10.1186/s13012-019-0921-3']
1957,32411324,L-Glutamine Supplementation Improves the Benefits of Combined-Exercise Training on Oral Redox Balance and Inflammatory Status in Elderly Individuals.,"Although regular combined aerobic-resistance exercises can ameliorate the inflammatory status and redox balance in elderly population, it is unclear whether protein or specific amino acid supplementation could improve such benefits. Therefore, we aimed to evaluate the inflammatory status and redox indexes through of the saliva of 34 elderly subject nonpractitioners (NP group, 73.3 ± 6.6 years) and 49 elderly subject practitioners of a combined-exercise training in moderate intensity (CET group, 71.9 ± 5.8 years) before (pre) and after (post) 30 days of supplementation with L-glutamine (Gln) or placebo (PL). Our results showed that, both in pre- and postsupplementation, the salivary levels of nitric oxide (NO · ) and TNF- α  were lower, whereas the levels of uric acid and IL-10 (as well as IL-10/TNF- α  ratio) were higher in the CET groups than in the NP groups. In postsupplementation, both groups supplemented with Gln (NP-Gln and CET-Gln) showed higher salivary uric acid levels compared to baseline. In addition, lower NO ·  levels were found in the CET-Gln group postsupplementation than presupplementation values. Whereas the CET-Gln group showed lower GSH levels postsupplementation, NP-Gln subjects showed lower GSSG levels at the same time point, both compared to baseline. Interestingly, salivary peroxidase activity was lower only in NP groups (NP-PL and NP-Gln) postsupplementation than baseline values. A positive significant correlation between salivary peroxidase activity and GSH levels, and also between salivary peroxidase activity and uric acid levels were observed in the CET-Gln group both pre- and postsupplementation. No differences were found in albumin, total antioxidant activity (TEAC), and reducing power analysis between groups, pre- or postsupplementation. In conclusion, the elderly subjects from the CET group showed a better inflammatory response and redox balance and, for the first time, it was shown that daily supplementation with Gln for 30 days can improve these benefits with putative association with a healthy aging.",2020,"No differences were found in albumin, total antioxidant activity (TEAC), and reducing power analysis between groups, pre- or postsupplementation.","['34 elderly subject nonpractitioners (NP group, 73.3 ± 6.6 years) and 49 elderly subject practitioners of a combined-exercise training in moderate intensity (CET group, 71.9 ± 5.8 years) before (pre) and after (post) 30 days of', 'Elderly Individuals', 'elderly population']","['CET-Gln', 'L-Glutamine Supplementation', 'CET', 'Combined-Exercise Training', 'Gln (NP-Gln and CET-Gln', 'supplementation with L-glutamine (Gln) or placebo (PL', 'regular combined aerobic-resistance exercises']","['salivary uric acid levels', 'levels of uric acid and IL-10', 'GSSG levels', 'salivary peroxidase activity and GSH levels', 'GSH levels', 'salivary peroxidase activity and uric acid levels', 'inflammatory response and redox balance', 'albumin, total antioxidant activity (TEAC), and reducing power analysis', 'salivary peroxidase activity', 'salivary levels of nitric oxide (NO · ) and TNF- α', 'Oral Redox Balance and Inflammatory Status']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0381931,"No differences were found in albumin, total antioxidant activity (TEAC), and reducing power analysis between groups, pre- or postsupplementation.","[{'ForeName': 'Ewin B', 'Initials': 'EB', 'LastName': 'Almeida', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Juliana M B', 'Initials': 'JMB', 'LastName': 'Santos', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Vitória', 'Initials': 'V', 'LastName': 'Paixão', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Jonatas B', 'Initials': 'JB', 'LastName': 'Amaral', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Foster', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Adriane', 'Initials': 'A', 'LastName': 'Sperandio', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Tamaris', 'Initials': 'T', 'LastName': 'Roseira', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Telma G', 'Initials': 'TG', 'LastName': 'Cordeiro', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Fernanda R', 'Initials': 'FR', 'LastName': 'Monteiro', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Gislene R', 'Initials': 'GR', 'LastName': 'Amirato', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Carlos A F', 'Initials': 'CAF', 'LastName': 'Santos', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Rodolfo P', 'Initials': 'RP', 'LastName': 'Vieira', 'Affiliation': 'Brazilian Institute of Teaching and Research in Pulmonary and Exercise Immunology (IBEPIPE), Rua Pedro Ernesto 240, São José dos Campos, SP 12245-520, Brazil.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Vaisberg', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}, {'ForeName': 'Marcelo P', 'Initials': 'MP', 'LastName': 'Barros', 'Affiliation': 'Interdisciplinary Postgraduate Program in Health Sciences, Institute of Physical Activity Sciences and Sports (ICAFE), Cruzeiro do Sul University, Rua Galvão Bueno 868, São Paulo, SP 01506-000, Brazil.'}, {'ForeName': 'André L L', 'Initials': 'ALL', 'LastName': 'Bachi', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of São Paulo (UNIFESP), Rua dos Otonis, 700, Piso superior/Second floor, Sao Paulo SP 04025-002, Brazil.'}]",Oxidative medicine and cellular longevity,['10.1155/2020/2852181']
1958,31467191,Endocrine responses during CPAP withdrawal in obstructive sleep apnoea: data from two randomised controlled trials.,"The aim of this investigation was to elucidate the effect of CPAP withdrawal on neurometabolic and cardiometabolic markers in patients with obstructive sleep apnoea. We evaluated 70 patients (mean age 61±10 years, 82% men) treated with CPAP in two 2-week, parallel, randomised controlled trials. CPAP withdrawal resulted in elevated 3,4-dihydroxyphenylglycol, norepinephrine and cortisol after 2 weeks of CPAP withdrawal; however, no statistically significant changes of the renin-angiotensin-aldosterone system (RAAS) determinants were documented. In summary, CPAP withdrawal may be more prominently linked to short-term increases in sympathetic activation than hypothalamic-pituitary-adrenal axis or RAAS activation. ClinicalTrials.gov Identifier: NCT02493673 and NCT02050425.",2019,"CPAP withdrawal resulted in elevated 3,4-dihydroxyphenylglycol, norepinephrine and cortisol after 2 weeks of CPAP withdrawal; however, no statistically significant changes of the renin-angiotensin-aldosterone system (RAAS) determinants were documented.","['patients with obstructive sleep apnoea', 'obstructive sleep apnoea', '70 patients (mean age 61±10 years, 82% men) treated with']","['CPAP withdrawal', 'CPAP']","['elevated 3,4-dihydroxyphenylglycol, norepinephrine and cortisol', 'renin-angiotensin-aldosterone system (RAAS) determinants', 'Endocrine responses', 'neurometabolic and cardiometabolic markers', 'sympathetic activation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0058144', 'cui_str': 'dihydroxyphenylglycine'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}]",,0.0648745,"CPAP withdrawal resulted in elevated 3,4-dihydroxyphenylglycol, norepinephrine and cortisol after 2 weeks of CPAP withdrawal; however, no statistically significant changes of the renin-angiotensin-aldosterone system (RAAS) determinants were documented.","[{'ForeName': 'Sira', 'Initials': 'S', 'LastName': 'Thiel', 'Affiliation': 'Department of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Haile', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Peitzsch', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.'}, {'ForeName': 'Esther I', 'Initials': 'EI', 'LastName': 'Schwarz', 'Affiliation': 'Department of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Noriane A', 'Initials': 'NA', 'LastName': 'Sievi', 'Affiliation': 'Department of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Salome', 'Initials': 'S', 'LastName': 'Kurth', 'Affiliation': 'Department of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Beuschlein', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': 'Department of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gaisl', 'Affiliation': 'Department of Pulmonology and Sleep Disorders Centre, University Hospital Zurich, Zurich, Switzerland thomas.gaisl@usz.ch.'}]",Thorax,['10.1136/thoraxjnl-2019-213522']
1959,31472419,"Comparison of telemedicine versus in-person visits for persons with multiple sclerosis: A randomized crossover study of feasibility, cost, and satisfaction.","BACKGROUND


Telemedicine, the remote delivery of health care services, increases access to care for patients with mobility or geographic limitations. Virtual house calls (VHCs) are one type of telemedicine in which clinical visits are conducted remotely using an audio-visual connection with the patient at home. Use of VHCs is more established in other neurologic disorders but is only recently being formally evaluated in multiple sclerosis (MS). This randomized crossover study systematically assessed VHCs compared with in-clinic visits in persons with MS.
METHODS


Recruitment occurred in a university based MS clinic. Each subject completed one VHC and one in-clinic follow-up visit. A 1:1 randomization determined whether the VHC or in-clinic follow-up visit occurred first. Baseline surveys included demographics and MS history; post-visit surveys elicited subject responses regarding each visit type to assess feasibility, satisfaction, and cost differences. Outcomes were compared using t-tests for continuous variables and Fisher's exact test for proportions.
RESULTS


Thirty-six participants completed both study visits and both post-visit surveys. VHC feasibility was demonstrated by a lack of statistically significant difference in the number of completed VHCs as compared with in-clinic visits. VHCs provided both cost and time savings to participants. The majority of participants reported that they would recommend telemedicine visits to others (97.1%) and rated it easy to connect via telemedicine (94.3%). In qualitative comments, participants expressed appreciation for VHCs due to convenience and similarity to in-clinic visits.
CONCLUSIONS


VHCs were found to be feasible, cost-effective, and appealing to persons with MS and physicians, supporting their utility as a care delivery method for MS.",2019,VHC feasibility was demonstrated by a lack of statistically significant difference in the number of completed VHCs as compared with in-clinic visits.,"['persons with multiple sclerosis', 'Thirty-six participants completed both study visits and both post-visit surveys', 'Recruitment occurred in a university based MS clinic', 'persons with MS', 'patients with mobility or geographic limitations']","['Virtual house calls (VHCs', 'VHCs', 'telemedicine']","['VHC feasibility', 'feasibility, satisfaction, and cost differences', 'cost and time savings']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}]","[{'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]",36.0,0.0524334,VHC feasibility was demonstrated by a lack of statistically significant difference in the number of completed VHCs as compared with in-clinic visits.,"[{'ForeName': 'Jessica F', 'Initials': 'JF', 'LastName': 'Robb', 'Affiliation': 'Department of Neurology, University of Rochester, Rochester, NY, United States. Electronic address: jessica_robb@urmc.rochester.edu.'}, {'ForeName': 'Megan H', 'Initials': 'MH', 'LastName': 'Hyland', 'Affiliation': 'Department of Neurology, University of Rochester, Rochester, NY, United States.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Goodman', 'Affiliation': 'Department of Neurology, University of Rochester, Rochester, NY, United States.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2019.05.001']
1960,32131642,Effects of deep thermotherapy on chest wall mobility of healthy elderly women.,"Chest wall mobility decreases with age in community-dwelling women aged 65 years or older. Thermotherapy is used to improve soft-tissue extensibility. However, its effects on chest wall mobility are unclear. This study aimed to examine the effect of thermotherapy on chest wall mobility in healthy elderly women. Twenty-eight elderly women participated in this study. Chest wall mobility at three levels (axillary, xiphoid, and tenth rib), respiratory function (forced vital capacity and forced expiratory volume), and tissue temperature (skin temperature (ST)) and deep temperature (DT) with 10 mm and 20 mm depth from the skin (10 mm DT and 20 mm DT)) were measured before and after 15 minutes of thermotherapy. The subjects randomly received one of the three interventions (capacitive and resistive electric transfer (CRet), hot pack (HP), and sham CRet (sham)). Chest wall mobility at all levels significantly increased after CRet intervention. Hot pack significantly increased tenth rib excursion; it also significantly increased ST, 10 mm DT, and 20 mm DT, whereas CRet significantly increased 10 mm DT and 20 mm DT. There were significant differences between CRet, HP, and sham in ST, 10 mm DT, and 20 mm DT. Furthermore, 20 mm DT had increased more in CRet than in HP. CRet improved chest wall mobility at all levels and HP improved at the tenth rib level. This implies that CRet can be one of the approaches to improve chest wall mobility.",2020,"There were significant differences between CRet, HP, and sham in ST, 10 mm DT, and 20 mm DT.","['healthy elderly women', 'Twenty-eight elderly women participated in this study', 'community-dwelling women aged 65\xa0years or older']","['Thermotherapy', 'deep thermotherapy', 'thermotherapy', 'three interventions (capacitive and resistive electric transfer (CRet), hot pack (HP), and sham CRet (sham']","['CRet', 'Chest wall mobility', 'Hot pack significantly increased tenth rib excursion', 'chest wall mobility at all levels and HP', 'Chest wall mobility at three levels (axillary, xiphoid, and tenth rib), respiratory function (forced vital capacity and forced expiratory volume), and tissue temperature (skin temperature (ST)) and deep temperature (DT) with 10 mm and 20 mm depth from the skin (10 mm DT and 20 mm DT']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0020548', 'cui_str': 'Fever Therapy'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205076', 'cui_str': 'Chest Wall'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0222945', 'cui_str': 'Bone structure of tenth rib'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]",28.0,0.0213685,"There were significant differences between CRet, HP, and sham in ST, 10 mm DT, and 20 mm DT.","[{'ForeName': 'Tsubasa', 'Initials': 'T', 'LastName': 'Bito', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}, {'ForeName': 'Yuu', 'Initials': 'Y', 'LastName': 'Kajiwara', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Zeidan', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}, {'ForeName': 'Kanako', 'Initials': 'K', 'LastName': 'Shimoura', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Tatsumi', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Nakai', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Nishida', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}, {'ForeName': 'Soyoka', 'Initials': 'S', 'LastName': 'Yoshimi', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}, {'ForeName': 'Rika', 'Initials': 'R', 'LastName': 'Kawabe', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}, {'ForeName': 'Junpei', 'Initials': 'J', 'LastName': 'Yokota', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Yamashiro', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Tsuboyama', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Aoyama', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Sakyo-ku, Japan.'}]",Electromagnetic biology and medicine,['10.1080/15368378.2020.1737803']
1961,32411717,Intravenous Cyclophosphamide in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. An Open-Label Phase II Study.,"Introduction:  Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a disease with high symptom burden, of unknown etiology, with no established treatment. We observed patients with long-standing ME/CFS who got cancer, and who reported improvement of ME/CFS symptoms after chemotherapy including cyclophosphamide, forming the basis for this prospective trial.  Materials and methods:  This open-label phase II trial included 40 patients with ME/CFS diagnosed by Canadian criteria. Treatment consisted of six intravenous infusions of cyclophosphamide, 600-700 mg/m 2 , given at four-week intervals with follow-up for 18 months, extended to 4 years. Response was defined by self-reported improvements in symptoms by Fatigue score, supported by Short Form 36 (SF-36) scores, physical activity measures and other instruments. Repeated measures of outcome variables were assessed by General linear models. Responses were correlated with specific Human Leukocyte Antigen (HLA) alleles.  Results:  The overall response rate by Fatigue score was 55.0% (22 of 40 patients). Fatigue score and other outcome variables showed significant improvements compared to baseline. The SF-36 Physical Function score increased from mean 33.0 at baseline to 51.5 at 18 months (all patients), and from mean 35.0 to 69.5 among responders. Mean steps per 24 h increased from mean 3,199 at baseline to 4,347 at 18 months (all patients), and from 3,622 to 5,589 among responders. At extended follow-up to 4 years 68% (15 of 22 responders) were still in remission. Patients positive for HLA-DQB1 * 03:03 and/or HLA-C * 07:04 ( n  = 12) had significantly higher response rate compared to patients negative for these alleles ( n  = 28), 83 vs. 43%, respectively. Nausea and constipation were common grade 1-2 adverse events. There were one suspected unexpected serious adverse reaction (aggravated POTS) and 11 serious adverse events in eight patients.  Conclusion:  Intravenous cyclophosphamide treatment was feasible for ME/CFS patients and associated with an acceptable toxicity profile. More than half of the patients responded and with prolonged follow-up, a considerable proportion of patients reported ongoing remission. Without a placebo group, clinical response data must be interpreted with caution. We nevertheless believe a future randomized trial is warranted.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier: NCT02444091.",2020,"The SF-36 Physical Function score increased from mean 33.0 at baseline to 51.5 at 18 months (all patients), and from mean 35.0 to 69.5 among responders.","['40 patients with ME/CFS diagnosed by Canadian criteria', 'Myalgic Encephalomyelitis/Chronic Fatigue Syndrome']","['Intravenous Cyclophosphamide', 'Intravenous cyclophosphamide', 'cyclophosphamide', 'placebo']","['specific Human Leukocyte Antigen (HLA) alleles', 'Fatigue score', 'Nausea and constipation', 'acceptable toxicity profile', 'overall response rate by Fatigue score', 'HLA-DQB1', 'SF-36 Physical Function score', 'ME/CFS symptoms', 'serious adverse reaction (aggravated POTS) and 11 serious adverse events', 'Mean steps per 24 h', 'response rate', 'symptoms by Fatigue score, supported by Short Form 36 (SF-36) scores, physical activity measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0555907', 'cui_str': 'Human leukocyte antigen allele'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0122020', 'cui_str': 'HLA-DQB1 antigen'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0024809', 'cui_str': 'Marihuana Abuse'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",40.0,0.0705803,"The SF-36 Physical Function score increased from mean 33.0 at baseline to 51.5 at 18 months (all patients), and from mean 35.0 to 69.5 among responders.","[{'ForeName': 'Ingrid G', 'Initials': 'IG', 'LastName': 'Rekeland', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fosså', 'Affiliation': 'Department of Oncology, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Asgeir', 'Initials': 'A', 'LastName': 'Lande', 'Affiliation': 'Department of Medical Genetics, Oslo University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Ktoridou-Valen', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Sørland', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Holsen', 'Affiliation': 'Clinical Research Unit, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Karl J', 'Initials': 'KJ', 'LastName': 'Tronstad', 'Affiliation': 'Department of Biomedicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Risa', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Kine', 'Initials': 'K', 'LastName': 'Alme', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Marte K', 'Initials': 'MK', 'LastName': 'Viken', 'Affiliation': 'Department of Medical Genetics, Oslo University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Benedicte A', 'Initials': 'BA', 'LastName': 'Lie', 'Affiliation': 'Department of Medical Genetics, Oslo University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Dahl', 'Affiliation': 'Department of Biomedicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Mella', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Fluge', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}]",Frontiers in medicine,['10.3389/fmed.2020.00162']
1962,29370008,"Initiating Nutritional Support Before 72 Hours Is Associated With Favorable Outcome After Severe Traumatic Brain Injury in Children: A Secondary Analysis of a Randomized, Controlled Trial of Therapeutic Hypothermia.","OBJECTIVES


To understand the relationship between the timing of initiation of nutritional support in children with severe traumatic brain injury and outcomes.
DESIGN


Secondary analysis of a randomized, controlled trial of therapeutic hypothermia (Pediatric Traumatic Brain Injury Consortium: Hypothermia, also known as ""the Cool Kids Trial"" (NCT 00222742).
SETTINGS


Fifteen clinical sites in the United States, Australia, and New Zealand.
SUBJECTS


Inclusion criteria included 1) age less than 18 years, 2) postresuscitation Glasgow Coma Scale less than or equal to 8, 3) Glasgow Coma Scale motor score less than 6, and 4) available to be randomized within 6 hours after injury. Exclusion criteria included normal head CT, Glasgow Coma Scale equals to 3, hypotension for greater than 10 minutes (< fifth percentile for age), uncorrectable coagulopathy, hypoxia (arterial oxygen saturation < 90% for > 30 min), pregnancy, penetrating injury, and unavailability of a parent or guardian to consent at centers without emergency waiver of consent.
INTERVENTIONS


Therapeutic hypothermia (32-33°C for 48 hr) followed by slow rewarming for the primary study. For this analysis, the only intervention was the extraction of data regarding nutritional support from the existing database.
MEASUREMENTS AND MAIN RESULTS


Timing of initiation of nutritional support was determined and patients stratified into four groups (group 1-no nutritional support over first 7 d; group 2-nutritional support initiated < 48 hr after injury; group 3-nutritional support initiated 48 to < 72 hr after injury; group 4-nutritional support initiated 72-168 hr after injury). Outcomes were also stratified (mortality and Glasgow Outcomes Scale-Extended for Pediatrics; 1-4, 5-7, 8) at 6 and 12 months. Mixed-effects models were performed to define the relationship between nutrition and outcome. Children (n = 90, 77 randomized, 13 run-in) were enrolled (mean Glasgow Coma Scale = 5.8); the mortality rate was 13.3%. 57.8% of subjects received hypothermia Initiation of nutrition before 72 hours was associated with survival (p = 0.01), favorable 6 months Glasgow Outcomes Scale-Extended for Pediatrics (p = 0.03), and favorable 12 months Glasgow Outcomes Scale-Extended for Pediatrics (p = 0.04). Specifically, groups 2 and 3 had favorable outcomes versus group 1.
CONCLUSIONS


Initiation of nutritional support before 72 hours after traumatic brain injury was associated with decreased mortality and favorable outcome in this secondary analysis. Although this provides a rationale to initiate nutritional support early after traumatic brain injury, definitive studies that control for important covariates (severity of injury, clinical site, calories delivered, parenteral/enteral routes, and other factors) are needed to provide definitive evidence on the optimization of the timing of nutritional support after severe traumatic brain injury in children.",2018,"57.8% of subjects received hypothermia Initiation of nutrition before 72 hours was associated with survival (p = 0.01), favorable 6 months Glasgow Outcomes Scale-Extended for Pediatrics (p = 0.03), and favorable 12 months","['Pediatric Traumatic Brain Injury Consortium', 'Fifteen clinical sites in the United States, Australia, and New Zealand', 'Inclusion criteria included 1) age less than 18 years, 2) postresuscitation Glasgow Coma Scale less than or equal to 8, 3) Glasgow Coma Scale motor score less than 6, and 4) available to be randomized within 6 hours after injury', 'for greater than 10 minutes (< fifth percentile for age), uncorrectable coagulopathy, hypoxia (arterial oxygen saturation < 90% for > 30\u2009min), pregnancy, penetrating injury, and unavailability of a parent or guardian to consent at centers without emergency waiver of consent', 'children with severe traumatic brain injury and outcomes', 'Children']","['therapeutic hypothermia', 'Therapeutic hypothermia', 'Initiating Nutritional Support']","['survival', 'mortality rate', 'normal head CT, Glasgow Coma Scale equals to 3, hypotension', 'Glasgow Outcomes Scale-Extended for Pediatrics', 'stratified (mortality and Glasgow Outcomes Scale-Extended for Pediatrics', 'favorable 6 months Glasgow Outcomes Scale-Extended for Pediatrics']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1299357', 'cui_str': 'Fifth percentile'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0043254', 'cui_str': 'Wounds, Penetrating'}, {'cui': 'C0686905', 'cui_str': 'Unavailability'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0242739', 'cui_str': 'Nutritional Support'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0202691', 'cui_str': 'Computerized tomography of head'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0701887', 'cui_str': 'Glasgow Outcome Scale'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.0569743,"57.8% of subjects received hypothermia Initiation of nutrition before 72 hours was associated with survival (p = 0.01), favorable 6 months Glasgow Outcomes Scale-Extended for Pediatrics (p = 0.03), and favorable 12 months","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Meinert', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bell', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Buttram', 'Affiliation': ""Department of Neurological Surgery, Barrow Neurological Institute and Phoenix Children's, Phoenix, AZ.""}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Kochanek', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Goundappa K', 'Initials': 'GK', 'LastName': 'Balasubramani', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'P David', 'Initials': 'PD', 'LastName': 'Adelson', 'Affiliation': ""Department of Neurological Surgery, Barrow Neurological Institute and Phoenix Children's, Phoenix, AZ.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000001471']
1963,32411517,Evaluating the stress-response of dental students to the dental school environment.,"Introduction and Objective


Dentists experience high amounts of professional stress beginning with their student years in dental school. This stress, given its early onset, may negatively impact the personal and professional lives of these individuals, as well as the quality of their clinical work. We sought to create an objective scale to evaluate the levels of stress in students at different stages of their education, as well as in practicing physicians.
Materials and Methods


Thirty dental students participated in this study, with 10 students each selected from junior, mid-senior, and senior classes. They were randomly divided into two groups in which one group was subjected to stressors while the other group was not. JINS MEME ES_R (JINS) smart glasses and Garmin Vivoactive 3 smartwatches were used to obtain data, including electrooculography (EOG), heart rate (HR), and accelerometer (ACC) and gyroscope (GYRO) feedback, while the subjects performed a dental exercise on a phantom tooth.
Results


The heart rates of more experienced students were lower than those of the junior students. The EOG, ACC, and GYRO signals showed multiple differences in the measurement of amplitudes and frequency of episodes.
Conclusion


Our pilot results show that electronic tools, like smart glasses with software and sensors, are useful for monitoring the stress levels of dental students in preclinical operating conditions. We would like to further assess the stress levels in students performing dental procedures on phantom teeth and in later clinical interactions with patients.",2020,"Our pilot results show that electronic tools, like smart glasses with software and sensors, are useful for monitoring the stress levels of dental students in preclinical operating conditions.","['students at different stages of their education, as well as in practicing physicians', 'dental students to the dental school environment', 'professional stress beginning with their student years in dental school', 'students performing dental procedures on phantom teeth and in later clinical interactions with patients', 'Thirty dental students participated in this study, with 10 students each selected from junior, mid-senior, and senior classes']",[],"['electrooculography (EOG), heart rate (HR), and accelerometer (ACC) and gyroscope (GYRO) feedback', 'heart rates', 'amplitudes and frequency of episodes']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0036376', 'cui_str': 'Dental School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",[],"[{'cui': 'C0013854', 'cui_str': 'Electro-oculogram examination'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",30.0,0.0162069,"Our pilot results show that electronic tools, like smart glasses with software and sensors, are useful for monitoring the stress levels of dental students in preclinical operating conditions.","[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Mocny-Pachońska', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Medical University of Silesia, Faculty of Medical Science, Bytom, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Doniec', 'Affiliation': 'Faculty of Biomedical Engineering, Department of Biosensors and Biomedical Signal Processing, Silesian University of Technology, Zabrze, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Trzcionka', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Medical University of Silesia, Faculty of Medical Science, Bytom, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Pachoński', 'Affiliation': 'Pachonscy Dental Clinic, Strzebiń, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Piaseczna', 'Affiliation': 'Faculty of Biomedical Engineering, Department of Biosensors and Biomedical Signal Processing, Silesian University of Technology, Zabrze, Poland.'}, {'ForeName': 'Szymon', 'Initials': 'S', 'LastName': 'Sieciński', 'Affiliation': 'Faculty of Biomedical Engineering, Department of Biosensors and Biomedical Signal Processing, Silesian University of Technology, Zabrze, Poland.'}, {'ForeName': 'Oleksandra', 'Initials': 'O', 'LastName': 'Osadcha', 'Affiliation': 'Silesian University of Technology, Institute of Mathematics, Gliwice, Poland.'}, {'ForeName': 'Patrycja', 'Initials': 'P', 'LastName': 'Łanowy', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Medical University of Silesia, Faculty of Medical Science, Bytom, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Tanasiewicz', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Medical University of Silesia, Faculty of Medical Science, Bytom, Poland.'}]",PeerJ,['10.7717/peerj.8981']
1964,31607994,Leadership Training to Increase Need Satisfaction at Work: A Quasi-Experimental Mixed Method Study.,"With a growing number of studies showing the applicability of the self-determination theory for various work and organizational outcomes, the next logical step is to investigate if and how employee need satisfaction at work can be purposefully increased through an intervention. The purpose of the present study was to test whether we could train managers' display of autonomy, competence, and relatedness support toward employees and whether this resulted in improved employee need satisfaction, well-being, and job performance. Data were obtained from 37 managers (rated by  N  = 538 subordinates) assigned to either an experimental or control condition at three time points: before, during, and after the training. We also used focus group interviews to evaluate the experience of the training. The quantitative analyses showed no statistically significant improvement in managers' display of needs support or employee need satisfaction. However, the qualitative data pointed toward important factors related to the implementation of need supportive leadership training that should be considered.",2019,The quantitative analyses showed no statistically significant improvement in managers' display of needs support or employee need satisfaction.,[],['Leadership Training'],[],[],"[{'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],,0.015671,The quantitative analyses showed no statistically significant improvement in managers' display of needs support or employee need satisfaction.,"[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Tafvelin', 'Affiliation': 'Department of Psychology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Ulrica', 'Initials': 'U', 'LastName': 'von Thiele Schwarz', 'Affiliation': 'Medical Management Centre, Department of Learning, Informatics, Management and Ethics Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stenling', 'Affiliation': 'Department of Psychology, Umeå University, Umeå, Sweden.'}]",Frontiers in psychology,['10.3389/fpsyg.2019.02175']
1965,31605608,"Erratum to: SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial.",,2020,,"['1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}]",[],[],,0.0355185,,"[{'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz931']
1966,31030805,Objectively measured mobilisation is enhanced by a new behaviour support tool in patients undergoing abdominal cancer surgery.,"INTRODUCTION


Mobilisation reduces the risk of complications after abdominal surgery. Despite that, patients spend most of their time immobilised during hospital stay. Hence, the aim of this study was to evaluate a tool called the Activity board, which includes behaviour change techniques, regarding effects on mobilisation and postoperative recovery after abdominal cancer surgery.
MATERIAL AND METHODS


Patients who were planned for abdominal surgery due to colorectal, ovarian or urinary bladder cancer, and at least three postoperative days at Karolinska University Hospital were included in this non-randomised controlled trial, from January 2017 to May 2018. The patients were allocated to Activity board or standard treatment when they were admitted to hospital. Mobilisation was evaluated objectively with activity monitor the first three postoperative days, and postoperative recovery was assessed continuously during hospital stay.
RESULTS


In total, 133 patients, mean (sd) age 68.1 (12.3) years were included. The patients with the Activity board had postoperatively higher levels of mobilisation, compared to standard treatment, as mean value over the first three days, steps, median (min-max) 1057 (3-10433) and 360 (0-6546), respectively (p = 0.001), and for each day separately. Further, the group with the Activity board had a shorter length of stay, 6 (3-13), compared to standard treatment 7 (3-14) (p = 0.027).
CONCLUSION


The Activity board is an effective tool to enhance mobilisation after abdominal surgery due to cancer, in hospital settings. Using the Activity board could lead to improved postoperative recovery.",2019,"The patients with the Activity board had postoperatively higher levels of mobilisation, compared to standard treatment, as mean value over the first three days, steps, median (min-max) 1057 (3-10433) and 360 (0-6546), respectively (p = 0.001), and for each day separately.","['patients undergoing abdominal cancer surgery', 'In total, 133 patients, mean (sd) age 68.1 (12.3) years were included', 'Patients who were planned for abdominal surgery due to colorectal, ovarian or urinary bladder cancer, and at least three postoperative days at Karolinska University Hospital were included in this non-randomised controlled trial, from January 2017 to May 2018']",[],"['levels of mobilisation', 'postoperative recovery', 'shorter length of stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0920424'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0185112', 'cui_str': 'Mobilizing (regime/therapy)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",133.0,0.0571005,"The patients with the Activity board had postoperatively higher levels of mobilisation, compared to standard treatment, as mean value over the first three days, steps, median (min-max) 1057 (3-10433) and 360 (0-6546), respectively (p = 0.001), and for each day separately.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Porserud', 'Affiliation': 'Karolinska Institutet, Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Alfred Nobels Allé 23, 23100, 141 83, Huddinge, Sweden; Karolinska University Hospital, Function Area Occupational Therapy and Physiotherapy, Allied Health Professionals Function, 171 76, Stockholm, Sweden. Electronic address: andrea.porserud@ki.se.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Aly', 'Affiliation': 'Karolinska Institutet, Department of Medical Epidemiology and Biostatistics, 171 77, Stockholm, Sweden; Karolinska Institutet, Department of Molecular Medicine and Surgery, 171 77, Stockholm, Sweden; Karolinska University Hospital, Patient Area Pelvic Cancer, Theme Cancer, 171 76, Stockholm, Sweden. Electronic address: markus.aly@ki.se.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Nygren-Bonnier', 'Affiliation': 'Karolinska Institutet, Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Alfred Nobels Allé 23, 23100, 141 83, Huddinge, Sweden; Karolinska University Hospital, Function Area Occupational Therapy and Physiotherapy, Allied Health Professionals Function, 171 76, Stockholm, Sweden. Electronic address: malin.nygren-bonnier@ki.se.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hagströmer', 'Affiliation': 'Karolinska Institutet, Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Alfred Nobels Allé 23, 23100, 141 83, Huddinge, Sweden; Karolinska University Hospital, Function Area Occupational Therapy and Physiotherapy, Allied Health Professionals Function, 171 76, Stockholm, Sweden; Sophiahemmet University, Department of Health Promoting Science, Box 5605, 114 86, Stockholm, Sweden. Electronic address: maria.hagstromer@ki.se.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2019.04.013']
1967,31437698,Transcranial direct current stimulation for the treatment of generalized anxiety disorder: A randomized clinical trial.,"BACKGROUND


Generalized anxiety disorder (GAD) is a common condition with current treatments being only moderately effective. Non-invasive brain stimulation techniques might provide a novel approach for treating GAD. Transcranial direct current stimulation (tDCS) has shown promising efficacy and tolerability for major depression but has not been investigated for GAD yet. Thus, we investigated the effects of tDCS on patients with GAD.
METHODS


We conducted a pilot, double-blind, randomized, sham-controlled trial on 30 GAD patients. Five sessions of tDCS (2 mA, 20 min, anode over the left dorsolateral prefrontal cortex and cathode over the right supraorbital cortex) were performed. Anxiety was the primary outcome and it was measured by the Hamilton Anxiety Rating Scale and the Beck Anxiety Inventory. Secondary outcomes were accessed by the Lipp Inventory of Stress Symptoms for Adults, Positive and Negative Affect Schedule, and the Beck Depression Inventory (BDI). Data were examined at baseline, after the 5th day of intervention, and at 1-week follow-up.
RESULTS


Thirty patients finished the study. There were no significant improvements in anxiety, mood symptoms of stress, affectivity or depression. Anodal stimulation of the left DLPFC showed significant improvements in physical symptoms of stress in GAD patients.
LIMITATIONS


Additional tDCS sessions could have resulted in larger tDCS effects.
CONCLUSION


Five sessions of anodal tDCS over the DLPFC did not improve the main outcomes for GAD patients, although physical symptoms of stress were improved. The role of tDCS in GAD should be explored in larger patient samples using different parameters.",2019,"Five sessions of anodal tDCS over the DLPFC did not improve the main outcomes for GAD patients, although physical symptoms of stress were improved.","['generalized anxiety disorder', 'GAD patients', 'patients with GAD', 'Thirty patients finished the study', '30 GAD patients']","['tDCS', 'Transcranial direct current stimulation', 'Transcranial direct current stimulation (tDCS']","['Hamilton Anxiety Rating Scale and the Beck Anxiety Inventory', 'anxiety, mood symptoms of stress, affectivity or depression', 'Anxiety', 'Lipp Inventory of Stress Symptoms for Adults, Positive and Negative Affect Schedule, and the Beck Depression Inventory (BDI', 'physical symptoms of stress']","[{'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule (assessment scale)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",30.0,0.0858686,"Five sessions of anodal tDCS over the DLPFC did not improve the main outcomes for GAD patients, although physical symptoms of stress were improved.","[{'ForeName': 'Ana Lucia', 'Initials': 'AL', 'LastName': 'de Lima', 'Affiliation': 'Graduate Program in Rehabilitation Science, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Francisco Moisés Azevedo', 'Initials': 'FMA', 'LastName': 'Braga', 'Affiliation': 'Universidade Potiguar, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Rodrigo Maciel Medeiros', 'Initials': 'RMM', 'LastName': 'da Costa', 'Affiliation': 'Universidade Potiguar, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Elihab Pereira', 'Initials': 'EP', 'LastName': 'Gomes', 'Affiliation': 'Universidade Potiguar, Rio Grande do Norte, Brazil.'}, {'ForeName': 'André Russowsky', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil; Department of Internal Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Pegado', 'Affiliation': 'Graduate Program in Rehabilitation Science, Federal University of Rio Grande do Norte, Rio Grande do Norte, Brazil. Electronic address: rodrigopegado@gmail.com.'}]",Journal of affective disorders,['10.1016/j.jad.2019.08.020']
1968,29103065,"Effects of 12 months aerobic exercise intervention on work ability, need for recovery, productivity and rating of exertion among cleaners: a worksite RCT.","PURPOSE


This study assessed the effects of a worksite aerobic exercise intervention among cleaners on: work ability, need for recovery, productivity, and rating of exertion.
METHODS


In a monocentric randomised controlled trial in Denmark, 116, of 250 invited, cleaners were cluster-randomised (work location; sex; age; length of service) to aerobic exercise [N = 57, 44.9 years, 75.4% female, body mass index (BMI) 26.2], receiving 2 weekly aerobic exercise sessions during 12 months, or a reference group (N = 59, 45.7 years, 76.3% female, BMI 27.1), receiving health-promoting lectures. Self-reported data on outcomes and sociodemographic information were collected at baseline, and at 4 and 12 month follow-up. All outcomes were analysed in a linear repeated-measures 2 × 2 mixed-model by an intention-to-treat analysis approach.
RESULTS


Drop-out was 26 and 33% at 4 and 12 months, respectively. Aerobic exercise adherence was 51% during the first 4 months. At 4 month follow-up no effects were found. At 12 month follow-up, work ability significantly increased by 0.59 on a 0-10 scale (95% CI 0.05-1.13) and need for recovery significantly decreased by - 11.0 on a 0-100 scale (95% CI - 19.8 to - 2.2) in the aerobic exercise group compared to the reference group. Productivity and rating of exertion were unaltered. Analysis stratified on age showed significant effects only among the participants aged ≤ 45 years.
CONCLUSIONS


After 12 months work ability improved and need for recovery decreased. A period of 4 months was insufficient to affect these outcomes emphasising that longer interventions may be needed to induce effects on work ability and need for recovery.",2018,"At 12 month follow-up, work ability significantly increased by 0.59 on a 0-10 scale (95% CI 0.05-1.13) and need for recovery significantly decreased by - 11.0 on a 0-100 scale (95% CI - 19.8 to - 2.2) in the aerobic exercise group compared to the reference group.","['Denmark, 116, of 250 invited, cleaners were cluster-randomised (work location; sex; age; length of service) to aerobic exercise [N\xa0=\xa057, 44.9\xa0years, 75.4% female, body mass index (BMI) 26.2']","['receiving 2\xa0weekly aerobic exercise sessions', 'receiving health-promoting lectures', 'worksite aerobic exercise intervention', 'aerobic exercise intervention', 'aerobic exercise']","['Productivity and rating of exertion', ' work ability, need for recovery, productivity, and rating of exertion', 'need for recovery', 'Aerobic exercise adherence', 'work ability', 'work ability, need for recovery, productivity and rating of exertion']","[{'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}]","[{'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]",,0.0896324,"At 12 month follow-up, work ability significantly increased by 0.59 on a 0-10 scale (95% CI 0.05-1.13) and need for recovery significantly decreased by - 11.0 on a 0-100 scale (95% CI - 19.8 to - 2.2) in the aerobic exercise group compared to the reference group.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lidegaard', 'Affiliation': 'Centre for Ergonomics, Occupational Safety and Health, School of Health Sciences, College of Health, Massey University, Palmerston North, New Zealand. m.lidegaard@massey.ac.nz.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Søgaard', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Holtermann', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Korshøj', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}]",International archives of occupational and environmental health,['10.1007/s00420-017-1274-3']
1969,31599661,Altering meal timing to improve cognitive performance during simulated nightshifts.,"Altering meal timing could improve cognition, alertness, and thus safety during the nightshift. This study investigated the differential impact of consuming a meal, snack, or not eating during the nightshift on cognitive performance (ANZCTR12615001107516). 39 healthy participants (59% male, age mean±SD: 24.5 ± 5.0y) completed a 7-day laboratory study and underwent four simulated nightshifts. Participants were randomly allocated to: Meal at Night (MN;  n=  12), Snack at Night (SN;  n  = 13) or No Eating at Night (NE;  n  = 14). At 00:30 h, MN consumed a meal and SN consumed a snack (30% and 10% of 24 h energy intake respectively). NE did not eat during the nightshift. Macronutrient intake was constant across conditions. At 20:00 h, 22:30 h, 01:30 h, and 04:00 h, participants completed the 3-min Psychomotor Vigilance Task (PVT-B), 40-min driving simulator, post-drive PVT-B, subjective sleepiness scale, 2-choice Reaction Time task, and Running Memory task. Objective sleep was recorded for each of the day sleeps using Actigraphy and for the third day sleep, Polysomnography was used. Performance was compared between conditions using mixed model analyses. Significant two-way interactions were found. At 04:00 h, SN displayed increased time spent in the safe zone ( p  < .001; percentage of time spent within 10 km/h of the speed limit and 0.8 m of lane center), and decreases in speed variability ( p  < .001), lane variability ( p  < .001), post-drive PVT-B lapses (defined as RT > 355 ms;  p  < .001), and reaction time on the 2-choice reaction time task ( p  < .001) and running memory task ( p  < .001) compared to MN and NE. MN reported greater subjective sleepiness at 04:00 h ( p  < .001) compared to SN and NE. There was no difference in objective sleep between eating conditions. Eating a large meal during the nightshift impairs cognitive performance and sleepiness above the effects of time of night alone. For improved performance, shiftworkers should opt for a snack at night.",2019,MN reported greater subjective sleepiness at 04:00 h ( p  < .001) compared to SN and NE.,"['39 healthy participants (59% male, age mean±SD: 24.5\xa0±\xa05.0y) completed a 7-day laboratory study and underwent four simulated nightshifts']","['Meal at Night (MN;  n=\xa0 12), Snack at Night (SN;  n  =\xa013) or No Eating at Night (NE', 'NE']","['reaction time on the 2-choice reaction time task', 'cognition, alertness', '3-min Psychomotor Vigilance Task (PVT-B), 40-min driving simulator, post-drive PVT-B, subjective sleepiness scale, 2-choice Reaction Time task, and Running Memory task', 'running memory task', 'time spent', 'cognitive performance', 'Macronutrient intake', 'post-drive PVT-B lapses', 'objective sleep', 'Objective sleep', 'speed variability', 'lane variability', 'subjective sleepiness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",39.0,0.0365096,MN reported greater subjective sleepiness at 04:00 h ( p  < .001) compared to SN and NE.,"[{'ForeName': 'Charlotte C', 'Initials': 'CC', 'LastName': 'Gupta', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Centofanti', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Dorrian', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Coates', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Stepien', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kennaway', 'Affiliation': 'Robinson Research Institute and Adelaide School of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wittert', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Heilbronn', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Catcheside', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide Australia.'}, {'ForeName': 'Manny', 'Initials': 'M', 'LastName': 'Noakes', 'Affiliation': 'Food and Nutrition Flagship, Commonwealth Scientific and Industrial Research Organization, Adelaide, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Coro', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Dilushi', 'Initials': 'D', 'LastName': 'Chandrakumar', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Banks', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}]",Chronobiology international,['10.1080/07420528.2019.1676256']
1970,31866076,"Negative symptoms predict high relapse rates and both predict less favorable functional outcome in first episode psychosis, independent of treatment strategy.","BACKGROUND


In first episode psychosis (FEP) baseline negative symptoms (BNS) and relapse both predict less favorable functional outcome. Relapse-prevention is one of the most important goals of treatment. Apart from discontinuation of antipsychotics, natural causes of relapse are unexplained. We hypothesized that BNS, apart from predicting worse functional outcome, might also increase relapse risk.
METHODS


We performed a post-hoc analysis of 7-year follow-up data of a FEP cohort (n = 103) involved in a dose-reduction/discontinuation (DR) vs. maintenance treatment (MT) trial. We examined: 1) what predicted relapse, 2) what predicted functional outcome, and 3) if BNS predicted relapse, whether MT reduced relapse rates compared to DR. After remission patients were randomly assigned to DR or MT for 18 months. Thereafter, treatment was uncontrolled.
OUTCOMES


BNS and duration of untreated psychosis (DUP) predicted relapse. Number of relapses, BNS, and treatment strategy predicted functional outcome. BNS was the strongest predictor of relapse, while number of relapses was the strongest predictor of functional outcome above BNS and treatment strategy. Overall and within MT, but not within DR, more severe BNS predicted significantly higher relapse rates. Treatment strategies did not make a difference in relapse rates, regardless of BNS severity.
INTERPRETATION


BNS not only predicted worse functional outcome, but also relapses during follow-up. Since current low dose maintenance treatment strategies did not prevent relapse proneness in patients with more severe BNS, resources should be deployed to find optimal treatment strategies for this particular group of patients.",2020,"Treatment strategies did not make a difference in relapse rates, regardless of BNS severity.
",['After remission patients'],[],"['BNS and duration of untreated psychosis (DUP) predicted relapse', 'relapse rates', 'relapse rates, regardless of BNS severity']","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0099085', 'cui_str': '2-Naphthalenol, 6-bromo-, hydrogen sulfate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0518748,"Treatment strategies did not make a difference in relapse rates, regardless of BNS severity.
","[{'ForeName': 'Lex', 'Initials': 'L', 'LastName': 'Wunderink', 'Affiliation': 'Department of Research and Education, Friesland Mental Health Care Services, Sixmastraat 2, 8932 PA Leeuwarden, the Netherlands; Department of Psychiatry, University Medical Center Groningen, Groningen University, PO Box 30.001, 9700 RB Groningen, the Netherlands. Electronic address: lexwunderink@gmail.com.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van Bebber', 'Affiliation': 'Department of Psychiatry, University Medical Center Groningen, Groningen University, PO Box 30.001, 9700 RB Groningen, the Netherlands.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Sytema', 'Affiliation': 'Department of Psychiatry, University Medical Center Groningen, Groningen University, PO Box 30.001, 9700 RB Groningen, the Netherlands.'}, {'ForeName': 'Nynke', 'Initials': 'N', 'LastName': 'Boonstra', 'Affiliation': 'Department of Research and Education, Friesland Mental Health Care Services, Sixmastraat 2, 8932 PA Leeuwarden, the Netherlands; NHL Stenden University of Applied Science, Leeuwarden, the Netherlands.'}, {'ForeName': 'Rob R', 'Initials': 'RR', 'LastName': 'Meijer', 'Affiliation': 'Department of Psychometrics and Statistics, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Johanna T W', 'Initials': 'JTW', 'LastName': 'Wigman', 'Affiliation': 'Department of Psychiatry, University Medical Center Groningen, Groningen University, PO Box 30.001, 9700 RB Groningen, the Netherlands.'}]",Schizophrenia research,['10.1016/j.schres.2019.12.001']
1971,31601396,The Value of Left Ventricular Support in Patients With Reduced Left Ventricular Function Undergoing Extensive Revascularization: An Analysis From the PROTECT-II Randomized Trial.,,2019,,"['Patients With Reduced Left', 'Ventricular Function Undergoing Extensive Revascularization']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",[],[],,0.0427789,,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Burke', 'Affiliation': ''}, {'ForeName': 'Harun', 'Initials': 'H', 'LastName': 'Kundi', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Almonacid', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': ""O'Neill"", 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Moses', 'Affiliation': ''}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Kleiman', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dixon', 'Affiliation': ''}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Palacios', 'Affiliation': ''}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Guzman', 'Affiliation': ''}, {'ForeName': 'E Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': ''}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': ''}, {'ForeName': 'Duane S', 'Initials': 'DS', 'LastName': 'Pinto', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.07.050']
1972,29051274,Effect of morphine on breathlessness and exercise endurance in advanced COPD: a randomised crossover trial.,"The objective of the present study was to evaluate the effect of morphine on exertional breathlessness and exercise endurance in advanced chronic obstructive pulmonary disease (COPD).In a randomised crossover trial, we compared the acute effect of immediate-release oral morphine  versus  placebo on physiological and perceptual responses during constant-load cardiopulmonary cycle exercise testing (CPET) in 20 adults with advanced COPD and chronic breathlessness syndrome.Compared with placebo, morphine reduced exertional breathlessness at isotime by 1.2±0.4 Borg units and increased exercise endurance time by 2.5±0.9 min (both p≤0.014). During exercise at isotime, morphine decreased ventilation by 1.3±0.5 L·min -1  and breathing frequency by 2.0±0.9 breaths·min -1  (both p≤0.041). Compared with placebo, morphine decreased exertional breathlessness at isotime by ≥1 Borg unit in 11 participants (responders) and by <1 Borg unit in nine participants (non-responders). Baseline participant characteristics, including pulmonary function and cardiorespiratory fitness, were similar between responders and non-responders. A higher percentage of responders  versus  non-responders stopped incremental CPET due to intolerable breathlessness: 82  versus  33% (p=0.028).Immediate-release oral morphine improved exertional breathlessness and exercise endurance in some, but not all, adults with advanced COPD. The locus of symptom-limitation on laboratory-based CPET may help to identify patients most likely to benefit from morphine.",2017,"Compared with placebo, morphine reduced exertional breathlessness at isotime by 1.2±0.4 Borg units and increased exercise endurance time by 2.5±0.9 min (both p≤0.014).","['advanced chronic obstructive pulmonary disease', 'adults with advanced COPD', 'advanced COPD', '20 adults with advanced COPD and chronic breathlessness syndrome']","['morphine  versus  placebo', 'constant-load cardiopulmonary cycle exercise testing (CPET', 'morphine', 'placebo, morphine']","['pulmonary function and cardiorespiratory fitness', 'breathlessness and exercise endurance', 'exertional breathlessness and exercise endurance', 'physiological and perceptual responses', 'exertional breathlessness', 'exercise endurance time']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0055954', 'cui_str': 'CPET'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",20.0,0.126936,"Compared with placebo, morphine reduced exertional breathlessness at isotime by 1.2±0.4 Borg units and increased exercise endurance time by 2.5±0.9 min (both p≤0.014).","[{'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Abdallah', 'Affiliation': 'Clinical Exercise and Respiratory Physiology Laboratory, Dept of Kinesiology and Physical Education, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Wilkinson-Maitland', 'Affiliation': 'Clinical Exercise and Respiratory Physiology Laboratory, Dept of Kinesiology and Physical Education, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Saad', 'Affiliation': 'Jewish General Hospital and Mount Sinai Hospital Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Pei Zhi', 'Initials': 'PZ', 'LastName': 'Li', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montréal Chest Institute, McGill University Health Centre, Montréal, QC, Canada.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Smith', 'Affiliation': 'Clinical Exercise and Respiratory Physiology Laboratory, Dept of Kinesiology and Physical Education, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourbeau', 'Affiliation': 'Dept of Medicine, Respiratory Division, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Jensen', 'Affiliation': 'Clinical Exercise and Respiratory Physiology Laboratory, Dept of Kinesiology and Physical Education, McGill University, Montréal, QC, Canada dennis.jensen@mcgill.ca.'}]",The European respiratory journal,['10.1183/13993003.01235-2017']
1973,31521645,3-Year Outcomes of the DKCRUSH-V Trial Comparing DK Crush With Provisional Stenting for Left Main Bifurcation Lesions.,"OBJECTIVES


The present study aimed to investigate the difference in target lesion failure (TLF) at 3 years after double kissing (DK) crush stenting versus provisional stenting (PS) for unprotected left main distal bifurcation (UPLMb) lesions.
BACKGROUND


The multicenter and randomized DKCRUSH-V (Double Kissing Crush versus Provisional Stenting for Left Main Distal Bifurcation Lesions: The DKCRUSH-V Randomized Trial) study showed fewer 1-year TLF after DK crush for UPLMb lesions compared with PS. The study reports the 3-year clinical outcome of the DKCRUSH-V study.
METHODS


A total of 482 patients with UPLMb lesions who were randomly assigned to either the DK crush group (DK group) or PS group in the DKCRUSH-V study were followed for 3 years. The primary endpoint was the occurrence of a TLF at 3 years. Stent thrombosis (ST) was the safety endpoint. Patients were classified by lesion's complexity and NERS (New Risk Stratification) II or SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score.
RESULTS


At 3 years, TLF occurred in 41 (16.9%) patients in the PS group and in 20 (8.3%) patients in the DK group (p = 0.005), mainly driven by increased target vessel myocardial infarction (5.8% vs. 1.7%; p = 0.017) and target lesion revascularization (10.3% vs. 5.0%; p = 0.029). Definite or probable ST rate at 3 years was 4.1% in the PS group and 0.4% in the DK group (p = 0.006). Notably, DK crush was associated with a significant reduction in both primary and secondary endpoints for patients with complex lesions or at high risk.
CONCLUSIONS


Provisional stenting for UPLMb lesions was associated with significantly increased rates of TLF and ST over 3 years of follow-up. Further randomized study is warranted to confirm the benefits of DK crush stenting for complex UPLMb lesions. (Double Kissing and Double Crush versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-center Clinical Trial; ChiCTR-TRC-11001213).",2019,Provisional stenting for UPLMb lesions was associated with significantly increased rates of TLF and ST over 3 years of follow-up.,"[""Patients were classified by lesion's complexity and NERS (New Risk Stratification) II or SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score"", '482 patients with UPLMb lesions', 'Left Main Distal Bifurcation Lesions']","['DKCRUSH-V (Double Kissing Crush versus Provisional Stenting', 'double kissing (DK) crush stenting versus provisional stenting (PS', 'Provisional Stenting', 'Double Kissing and Double Crush versus Provisional T Stenting Technique', 'DK crush stenting', 'DK crush group (DK group) or PS', 'Provisional stenting']","['target vessel myocardial infarction', 'Definite or probable ST rate', 'rates of TLF and ST', 'Stent thrombosis (ST', 'TLF', 'occurrence of a TLF', 'target lesion failure (TLF', 'target lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0330199', 'cui_str': 'Taxus'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0185060', 'cui_str': 'Crushing - action (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",482.0,0.181288,Provisional stenting for UPLMb lesions was associated with significantly increased rates of TLF and ST over 3 years of follow-up.,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Division of Cardiology, Shenyang Northen Hospital, Shenyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Kan', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lianglong', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, United Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Chunguang', 'Initials': 'C', 'LastName': 'Qiu', 'Affiliation': 'Division of Cardiology, Zhengzhou University First Hospital, Zhengzhou, China.'}, {'ForeName': 'Teguh', 'Initials': 'T', 'LastName': 'Santoso', 'Affiliation': 'Division of Cardiology, Medistra Hospital, University of Indonesia Medical School, Jakarta, Indonesia.'}, {'ForeName': 'Chootopol', 'Initials': 'C', 'LastName': 'Paiboon', 'Affiliation': 'Division of Cardiology, Bangkok General Hospital, Bangkok, Thailand.'}, {'ForeName': 'Tak W', 'Initials': 'TW', 'LastName': 'Kwan', 'Affiliation': 'Division of Cardiology, Beth Israel Hospital, New York, New York.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Sheiban', 'Affiliation': 'Division of Cardiology, Pederzoli Hospital-Peschiera del Garda, Verona, Italy.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Division of Cardiology, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Division of Cardiology, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York. Electronic address: gs2184@columbia.edu.'}, {'ForeName': 'Shao-Liang', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China; Key Laboratory of Cardiovascular and Cerebrovascular Medicine, School of Pharmacy, Nanjing Medical University, Nanjing, China. Electronic address: chmengx@126.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.04.056']
1974,32411845,Passive exposure to e-cigarette emissions: Immediate respiratory effects.,"INTRODUCTION


The present work examined the effect of passive exposure to electronic-cigarette (e-cigarette) emissions on respiratory mechanics and exhaled inflammatory biomarkers.
METHODS


A cross-over experimental study was conducted with 40 healthy nonsmokers, 18-35 years old with normal physical examination and spirometry, with body mass index <30 kg/m 2 , who were exposed to e-cigarette emissions produced by a smoker, according to a standardized protocol based on two resistance settings, 0.5 ohm and 1.5 ohm, for e-cigarette use. All participants underwent a 30-minute control (no emissions) and two experimental sessions (0.5 and 1.5 ohm exposure) in a 35 m 3  room. The following Impulse Oscillometry (IOS) parameters were measured at pre and post sessions: impedance, resistance, reactance, resonant frequency ( fres ), frequency dependence of resistance ( fdr =R5-R20), reactance area (AX), and fractional exhaled nitric oxide (FeNO). Differences between pre and post measurements were compared using t-tests and Wilcoxon signed rank tests, while analysis of variance (ANOVA) was used for comparisons between experimental sessions (registered under ClinicalTrials.gov ID: NCT03102684).
RESULTS


IOS and FeNO parameters showed no significant changes during the control session. For IOS during the 1.5 ohm exposure session,  fres  increased significantly from 11.38 Hz at baseline to 12.16 Hz post exposure (p=0.047). FeNO decreased significantly from 24.16 ppb at baseline to 22.35 ppb post exposure in the 0.5 ohm session (p=0.006).
CONCLUSIONS


A 30-minute passive exposure to e-cigarette emissions revealed immediate alterations in respiratory mechanics and exhaled biomarkers, expressed as increased  fres  and reduced FeNO.",2018,"FeNO decreased significantly from 24.16 ppb at baseline to 22.35 ppb post exposure in the 0.5 ohm session (p=0.006).
","['40 healthy nonsmokers, 18-35 years old with normal physical examination and spirometry, with body mass index <30 kg/m 2 , who were exposed to e-cigarette emissions produced by a smoker, according to a standardized protocol based on two resistance settings, 0.5 ohm and 1.5 ohm, for e-cigarette use']","['30-minute control (no emissions) and two experimental sessions', 'passive exposure to electronic-cigarette (e-cigarette) emissions']","['impedance, resistance, reactance, resonant frequency ( fres ), frequency dependence of resistance ( fdr =R5-R20), reactance area (AX), and fractional exhaled nitric oxide (FeNO', 'respiratory mechanics and exhaled biomarkers, expressed as increased  fres  and reduced FeNO', 'FeNO', 'Impulse Oscillometry (IOS) parameters']","[{'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0560037', 'cui_str': 'ohm'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4083280', 'cui_str': 'Vape'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}]","[{'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0577554', 'cui_str': 'Resonant'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0029375', 'cui_str': 'Oscillometry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",40.0,0.0151613,"FeNO decreased significantly from 24.16 ppb at baseline to 22.35 ppb post exposure in the 0.5 ohm session (p=0.006).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tzortzi', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'Stephanie I', 'Initials': 'SI', 'LastName': 'Teloniatis', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Matiampa', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Bakelas', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'Vergina K', 'Initials': 'VK', 'LastName': 'Vyzikidou', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Vardavas', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'Panagiotis K', 'Initials': 'PK', 'LastName': 'Behrakis', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'Esteve', 'Initials': 'E', 'LastName': 'Fernandez', 'Affiliation': ""Tobacco Control Unit, Institut Català d'Oncologia (ICO) and Institut d'Investigació Bioomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}]",Tobacco prevention & cessation,['10.18332/tpc/89977']
1975,32411850,Ups and downs of a peer-based smoking cessation intervention help tailored to hospital-employees with low socioeconomic status: The RESPEKT Study.,"INTRODUCTION


Smoking is one of the most important determinants of socioeconomic inequality in mortality. Few studies have tested which interventions are effective in smokers with low socioeconomic status (SES).
METHODS


All hospitals in the Capital Region of Denmark were included and randomized to intervention or control groups. The target-group was smokers with low SES. Intervention hospitals: smokers in the target-group assisted researchers to tailor a group-based smoking cessation intervention. Further they helped recruiting smoking colleagues and motivating them to stay abstinent. Control hospitals: 'as usual'. Unforeseen organizational challenges led to a change of study design; the hospital-level assessment was reduced to two cross-sectional surveys.
RESULTS


Response rates in hospitals' smoking status survey were very low. Smoking status was reported by 1876 out of 7003 employees at baseline and 2280 out of 7496 employees at 1-year follow-up. Two cross-sectional surveys showed no significant difference in self-reported smoking at 1-year follow-up between intervention and control hospitals (p=0.262). We recruited 100 smokers in the group-based smoking cessation intervention tailored to smokers with low SES (corresponding to approx. 10% of smokers in target-group); 32.4% of these were validated as continuously abstinent at 6 months follow-up.
CONCLUSIONS


Involving smokers with low SES as partners at an early stage of study design facilitated both recruitment and development of the intervention. Despite high validated long-term abstinence rates in smoking cessation groups in the intervention hospitals we found no apparent effect of the intervention at hospital-level after one year. However, larger involvement of the target-group seems feasible and is recommended.",2018,Two cross-sectional surveys showed no significant difference in self-reported smoking at 1-year follow-up between intervention and control hospitals (p=0.262).,"['All hospitals in the Capital Region of Denmark', '1876 out of 7003 employees at baseline and 2280 out of 7496 employees at 1-year follow-up', '100 smokers in the group-based smoking cessation intervention tailored to smokers with low SES (corresponding to approx', 'hospital-employees with low socioeconomic status', 'smokers with low socioeconomic status (SES']","['Ups and downs of a peer-based smoking cessation intervention', 'target-group assisted researchers to tailor a group-based smoking cessation intervention']",[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}]","[{'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]",[],7496.0,0.019698,Two cross-sectional surveys showed no significant difference in self-reported smoking at 1-year follow-up between intervention and control hospitals (p=0.262).,"[{'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Pisinger', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Maj-Britt Bjerre', 'Initials': 'MB', 'LastName': 'Koch', 'Affiliation': 'Rygestopkonsulenterne Aps.'}, {'ForeName': 'Else', 'Initials': 'E', 'LastName': 'Hjortsø', 'Affiliation': 'Capital Region of Denmark, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Jørgensen', 'Affiliation': 'Institute of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Glümer', 'Affiliation': 'Center for Diabetes, Copenhagen, Denmark.'}]",Tobacco prevention & cessation,['10.18332/tpc/91426']
1976,32411728,Computed Tomography Angiography in Peripheral Arterial Disease: Comparison of Three Image Acquisition Techniques to Optimize Vascular Enhancement-Randomized Controlled Trial.,"Objectives:  To prospectively compare three image acquisition techniques in lower extremity CT angiography: the ""standard"" anterograde technique (SA), the adaptive anterograde technique (AA), and the retrograde acquisition technique (RA).  Materials and Methods:  Sixty consecutive patients were prospectively enrolled and randomized into three acquisition groups: 20 patients were evaluated with SA, 20 with AA as described by Qanadli et al., and 20 with caudocranial acquisition from the feet to the abdominal aorta (RA). Quantitative image quality was assessed by measuring the intraluminal attenuation at different levels of interest, with a total of 536 levels. Qualitative image quality was assessed by two radiologists in consensus using a Likert scale to rate the arterial enhancement and venous return. For each patient and limb, the presence of occlusive or aneurysmal disease was documented.  Results:  In quantitative analysis, RA showed lower attenuation values than SA and AA ( p  < 0.01). AA showed the highest and most homogeneous attenuation along the arterial tree. In qualitative analysis, AA had the lowest rate of non-diagnostic vascular segments (3.9%) compared to SA and RA (4.7 and 13.1%, respectively,  p  < 0.01). The influence of venous return was significantly different among the different techniques; venous contamination was particularly prevalent at the aortic level with RA (9.4% of patients, 0% with SA and AA,  p  < 0.01). The presence of stenosis or occlusion had no significant influence on the attenuation values across all levels and acquisition techniques. Conversely, the presence of aneurysmal disease had a significant effect on the luminal attenuation in AA (higher attenuation) and RA (lower attenuation) at the iliac ( p  = 0.03 and 0.04, respectively) and femoral levels ( p  = 0.02 and <0.01, respectively).  Conclusion:  Considering both quantitative and qualitative analysis, AA performed better than SA and RA, providing the highest percentage of optimal vascular enhancement. AA should be recommended as the technique of choice, specifically in the presence of aneurysmal disease. Alternatively, SA can be useful in case of renal failure, as the test bolus is unnecessary. Finally, the increasing availability of fast CT systems will likely overcome the limitations of RA.",2020,"Considering both quantitative and qualitative analysis, AA performed better than SA and RA, providing the highest percentage of optimal vascular enhancement.","['Peripheral Arterial Disease', 'Sixty consecutive patients were prospectively enrolled and randomized into three acquisition groups: 20 patients were evaluated with SA, 20 with AA as described by Qanadli et al., and 20 with caudocranial acquisition from the feet to the abdominal aorta (RA']","['standard"" anterograde technique (SA', 'Computed Tomography Angiography']","['Quantitative image quality', 'femoral levels', 'venous return', 'lowest rate of non-diagnostic vascular segments', 'Qualitative image quality', 'luminal attenuation in AA']","[{'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003484', 'cui_str': 'Abdominal aorta structure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}]",60.0,0.040684,"Considering both quantitative and qualitative analysis, AA performed better than SA and RA, providing the highest percentage of optimal vascular enhancement.","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Rotzinger', 'Affiliation': 'Cardiothoracic and Vascular Division, Department of Diagnostic and Interventional Radiology, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Tri-Linh', 'Initials': 'TL', 'LastName': 'Lu', 'Affiliation': 'Cardiothoracic and Vascular Division, Department of Diagnostic and Interventional Radiology, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Kawkabani', 'Affiliation': ""Groupement Hospitalier de L'Ouest Lémanique, Nyon, Switzerland.""}, {'ForeName': 'Pedro-Manuel', 'Initials': 'PM', 'LastName': 'Marques-Vidal', 'Affiliation': 'Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Fetz', 'Affiliation': ""Clinica Sant'Anna, Sorengo, Switzerland.""}, {'ForeName': 'Salah D', 'Initials': 'SD', 'LastName': 'Qanadli', 'Affiliation': 'Cardiothoracic and Vascular Division, Department of Diagnostic and Interventional Radiology, Lausanne University Hospital, Lausanne, Switzerland.'}]",Frontiers in cardiovascular medicine,['10.3389/fcvm.2020.00068']
1977,32411853,The TOBg Tobacco Treatment Guidelines for Adolescents: A real-world pilot study.,"INTRODUCTION


We conducted a pilot study to: 1) obtain feedback from prevention practitioners in terms of their satisfaction, knowledge, and self-efficacy following exposure to the Tobacco Treatment Guidelines for Adolescents (TOBg Guidelines); and 2) examine the effectiveness of a school-based intervention based on the TOBg Guidelines on quit rates among a sample of adolescent tobacco users.
METHODS


Two parallel studies were conducted. In Study 1, prevention practitioners were exposed to a 1-day training in the TOBg Guidelines with assessment occurring before, immediately after, and at 6 months following the training. In Study 2, participating adolescent smokers were exposed to a 3-session group-based smoking cessation intervention that drew on the TOBg Guidelines and was delivered by practitioners trained in Study 1. The primary outcome measure was self-reported smoking status assessed at 1 month and at 6 months following baseline.
RESULTS


A total of 18 prevention practitioners and 65 adolescent tobacco users participated in the pilot study. The majority of practitioners reported high rates of satisfaction with the TOBg Guidelines and indicated that the guidelines positively influenced the manner in which they addressed tobacco use with adolescents. Prevention practitioners' self-efficacy for intervening with adolescent smokers was also significantly increased following exposure to the TOBg Guidelines and training. Among adolescents exposed to the school-based intervention, 62.5% and 23.1% had reduced smoking by 50% or more at 1 month and at 6 months follow-up, respectively. No significant change in smoking abstinence was documented.
CONCLUSIONS


The TOBg Guidelines for adolescent smokers were well received by prevention practitioners and were feasible to implement in a real-world school setting.",2018,Prevention practitioners' self-efficacy for intervening with adolescent smokers was also significantly increased following exposure to the TOBg Guidelines and training.,"['Adolescents', '18 prevention practitioners and 65 adolescent tobacco users participated in the pilot study', 'adolescent smokers', 'participating adolescent smokers', 'adolescent tobacco users']","['3-session group-based smoking cessation intervention that drew on the TOBg Guidelines', 'TOBg Guidelines']","['self-reported smoking status', 'smoking abstinence', 'quit rates', 'reduced smoking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C3853727', 'cui_str': 'Tobacco user'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]",,0.0228693,Prevention practitioners' self-efficacy for intervening with adolescent smokers was also significantly increased following exposure to the TOBg Guidelines and training.,"[{'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Fotiou', 'Affiliation': 'University Mental Health Research Institute (UMHRI), Athens, Greece.'}, {'ForeName': 'Myrto', 'Initials': 'M', 'LastName': 'Stavrou', 'Affiliation': 'University Mental Health Research Institute (UMHRI), Athens, Greece.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Papadakis', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, Canada.'}, {'ForeName': 'Panagiotis K', 'Initials': 'PK', 'LastName': 'Behrakis', 'Affiliation': 'George D. Behrakis Research Lab, Hellenic Cancer Society, Athens, Greece.'}, {'ForeName': 'Constantine I', 'Initials': 'CI', 'LastName': 'Vardavas', 'Affiliation': 'Institute of Public Health, American College of Greece, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kyriakidou', 'Affiliation': 'PYXIDA Prevention Centre, Thessaloniki, Greece.'}, {'ForeName': 'Sotiria', 'Initials': 'S', 'LastName': 'Makaroni', 'Affiliation': 'PRONOI Prevention Centre, Athens, Greece.'}, {'ForeName': 'Theodosia', 'Initials': 'T', 'LastName': 'Peleki', 'Affiliation': 'Institute of Public Health, American College of Greece, Athens, Greece.'}, {'ForeName': 'Vergina', 'Initials': 'V', 'LastName': 'Vyzikidou', 'Affiliation': 'Institute of Public Health, American College of Greece, Athens, Greece.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kokkevi', 'Affiliation': 'University Mental Health Research Institute (UMHRI), Athens, Greece.'}]",Tobacco prevention & cessation,['10.18332/tpc/93008']
1978,31851011,Effects of Home Exercises on Shoulder Pain and Pathology in Chronic Spinal Cord Injury: A Randomized Controlled Trial.,"OBJECTIVE


The aims of this study were to replicate findings that a home exercise program intervention improved shoulder pain and function and to assess changes in supraspinatus tendon pathology associated with the home exercise program in persons with chronic spinal cord injury.
DESIGN


The study is a single-blind randomized controlled trial. Individuals with spinal cord injury of at least 1 yr and chronic shoulder pain of moderate or greater average intensity were enrolled. Participants were randomized to a 12-wk home exercise program consisting of strengthening and stretching exercises or to an education-only control group, with immediate postintervention and 4-wk postintervention (16 wks) follow-ups. The main outcome measures were self-report measures of shoulder pain and impairment, the Physical Examination of the Shoulder Scale, quantitative ultrasound metrics of the supraspinatus tendon, and the Ultrasound Shoulder Pathology Rating Scale.
RESULTS


Thirty-two participants were randomized to home exercise program or education-only control condition. The mean ± SD age was 44.8 ± 12.5; 81.3% were male; 65.6% had motor complete paraplegia. Using a per-protocol, within-group analysis method, significant differences were observed between baseline and postintervention for the home exercise program group for the least pain intensity (P = 0.02), number of days with shoulder pain (P = 0.042), Physical Examination of the Shoulder Scale scores (dominant side, P = 0.036; nondominant side, P = 0.008), the Disabilities of the Arm, Shoulder, and Hand (P = 0.028), and the Patient Global Impression of Change (P = 0.015). The education-only control condition group demonstrated significant changes in average unpleasantness of shoulder pain after the intervention period (P = 0.049). Comparisons in changes from baseline between groups showed that the home exercise program group had greater improvements in nondominant-side Physical Examination of the Shoulder Scale scores and global impression of change, whereas the education-only control condition group had greater improvements in depressive symptoms.For quantitative ultrasound measures, no significant changes were found with within-group analyses for the home exercise program group, although the education-only control condition group demonstrated a decrease in tendon width in the nondominant-side supraspinatus tendon (P = 0.036). Comparison of changes between groups suggests that the education-only control condition group had a greater increase in dominant shoulder supraspinatus tendon ultrasound contrast at the end of the study.
CONCLUSIONS


Changes in several measures of shoulder pain and function occurred after the home exercise program intervention, although the magnitude of changes was only significantly greater than those of the education-only control condition group for two measures. Significant changes in supraspinatus pathology were not detected with quantitative ultrasound metrics.",2020,"Participants were randomized to a 12-week HEP consisting of strengthening and stretching exercises or to an education-only control group (CON), with immediate post-intervention and 4-week post-intervention (16 weeks) follow-ups.","['Individuals with SCI of at least 1 year and chronic shoulder pain of moderate or greater average intensity were enrolled', 'Chronic Spinal Cord Injury', '32 participants', 'Average age was 44.8 ', 'persons with chronic spinal cord injury (SCI']","['home exercise program (HEP) intervention', 'HEP consisting of strengthening and stretching exercises or to an education-only control group (CON), with immediate post-intervention and 4-week post-intervention', 'CON', 'Home Exercises', 'HEP or CON', 'HEP']","['tendon width', 'Patient Global Impression of Change', 'least pain intensity', 'self-report measures of shoulder pain and impairment, and the Physical Examination of the Shoulder Scale (PESS), quantitative ultrasound (QUS) metrics of the supraspinatus tendon, and the Ultrasound Shoulder Pathology Rating Scale (USPRS', 'depressive symptoms', 'supraspinatus pathology', 'motor complete paraplegia', 'PESS scores', 'shoulder pain and function', 'average unpleasantness of shoulder pain', 'Shoulder Pain and Pathology', 'number of days with shoulder pain', 'non-dominant side PESS scores and global impression of change']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0222045'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1659098', 'cui_str': 'Complete paraplegia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0445549', 'cui_str': 'Non-dominant side (qualifier value)'}]",32.0,0.0837195,"Participants were randomized to a 12-week HEP consisting of strengthening and stretching exercises or to an education-only control group (CON), with immediate post-intervention and 4-week post-intervention (16 weeks) follow-ups.","[{'ForeName': 'Diana D', 'Initials': 'DD', 'LastName': 'Cardenas', 'Affiliation': 'From the South Florida SCI Model System, Department of Physical Medicine & Rehabilitation, University of Miami Miller School of Medicine, Miami, Florida (DDC, ERF, RI); Miami Veterans Administration Medical Center, Miami, Florida (ERF); Department of Physical Medicine & Rehabilitation, University of Alabama at Birmingham, Birmingham, Alabama (RC); and Jackson Memorial Hospital, Miami, Florida (MFO).'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Felix', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Cowan', 'Affiliation': ''}, {'ForeName': 'Melanie F', 'Initials': 'MF', 'LastName': 'Orell', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Irwin', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001362']
1979,32411854,Short-term impact of the EuroPean Accredited Curriculum on Tobacco Treatment Training (EPACTT) program.,"INTRODUCTION


The aim of this pilot study was to assess the short-term effectiveness of the EuroPean Accredited Curriculum on Tobacco Treatment Training intervention in improving health care providers' knowledge, attitudes and self-efficacy related to tobacco dependence treatment.
METHODS


A pre-post pilot study was conducted. The two-day training intervention took place in Brussels in April 2016. Health care professionals from six European countries (Russia, Ukraine, Georgia, Armenia, Romania and Greece) were purposively invited to participate in the study. Evaluation was performed before the intervention, immediately after, and at approximately two months following the intervention. Changes in outcomes of interest were examined before and after exposure to the intervention program.
RESULTS


In all, 47 health care professionals participated in the training of which 40 completed the evaluation surveys. Significant increases in providers' self-efficacy and perceived behavioral control related to tobacco treatment delivery were documented immediately following the training and at the 2 months follow-up. Significant improvement in provider knowledge and attitudes were observed in some items assessed.
CONCLUSIONS


The results demonstrate that training is able to improve provider self-efficacy related to tobacco treatment delivery in this cross-national European sample of health care professionals. Additional research is required to examine the generalizability of our findings.",2018,Significant increases in providers' self-efficacy and perceived behavioral control related to tobacco treatment delivery were documented immediately following the training and at the 2 months follow-up.,"['47 health care professionals participated in the training of which 40 completed the evaluation surveys', 'Health care professionals from six European countries (Russia, Ukraine, Georgia, Armenia, Romania and Greece) were purposively invited to participate in the study']",['EuroPean Accredited Curriculum on Tobacco Treatment Training intervention'],"['provider self-efficacy', ""providers' self-efficacy and perceived behavioral control related to tobacco treatment delivery"", 'provider knowledge and attitudes']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C0017452', 'cui_str': 'Georgia state'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0114828,Significant increases in providers' self-efficacy and perceived behavioral control related to tobacco treatment delivery were documented immediately following the training and at the 2 months follow-up.,"[{'ForeName': 'Theodosia', 'Initials': 'T', 'LastName': 'Peleki', 'Affiliation': 'National and Kapodistrian University of Athens, School of Health Sciences, Department of Medicine, Athens, Greece.'}, {'ForeName': 'Charis', 'Initials': 'C', 'LastName': 'Girvalaki', 'Affiliation': 'Clinic of Social and Family Medicine, Medical School, University of Crete, Heraklion, Greece.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Lozano', 'Affiliation': 'European Network for Smoking and Tobacco Prevention (ENSP), Brussels, Belgium.'}, {'ForeName': 'Cornel', 'Initials': 'C', 'LastName': 'Radu-Loghin', 'Affiliation': 'European Network for Smoking and Tobacco Prevention (ENSP), Brussels, Belgium.'}, {'ForeName': 'Dominick', 'Initials': 'D', 'LastName': 'Nguyen', 'Affiliation': 'European Network for Smoking and Tobacco Prevention (ENSP), Brussels, Belgium.'}, {'ForeName': 'Arusyak', 'Initials': 'A', 'LastName': 'Harutyunyan', 'Affiliation': 'School of Public Health, American University of Armenia, Armenia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakhturidze', 'Affiliation': 'FCTC Implementation and Monitoring Center, Georgia.'}, {'ForeName': 'Antigona', 'Initials': 'A', 'LastName': 'Trofor', 'Affiliation': ""University of Medicine and Pharmacy 'Grigore T.Popa', Iasi, Romania.""}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Demin', 'Affiliation': 'Federal State Funded Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University under the Ministry of Health of the Russian Federation, Russia.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Stoyka', 'Affiliation': 'Kyiv City Health Center, Ukraine.'}, {'ForeName': 'Chrysoula', 'Initials': 'C', 'LastName': 'Tsiou', 'Affiliation': 'Technological Educational Institute of Athens, Greece.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Papadakis', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Constantine I', 'Initials': 'CI', 'LastName': 'Vardavas', 'Affiliation': 'European Network for Smoking and Tobacco Prevention (ENSP), Brussels, Belgium.'}, {'ForeName': 'Panagiotis K', 'Initials': 'PK', 'LastName': 'Behrakis', 'Affiliation': 'Institute of Public Health, American College of Greece, Athens, Greece.'}]",Tobacco prevention & cessation,['10.18332/tpc/92484']
1980,32411903,The effectiveness of family counselling on reducing exposure to secondhand smoke at home among pregnant women in Iran.,"INTRODUCTION


Pregnant women are often exposed to secondhand smoke that affects them and their child. Our aim was to determine the effectiveness of family counselling using the BASNEF model on reducing exposure to secondhand smoke at home among pregnant women.
METHODS


A quasi-experimental study was conducted on 103 pregnant women exposed to secondhand smoke. They were selected using a multi-stage cluster sampling method and allocated into intervention (50 people) and control (53 people) groups. Four family counseling sessions using the BASNEF model were held for the intervention group while the control group received routine care. The outcomes were measured before and at one month after the last session of counselling.
RESULTS


In the timeframe before the intervention, the number of days in which there was reported exposure to secondhand smoke was 5.08 ± 1.1 in the intervention group, significantly decreasing to 3.5 ± 1.6 after the intervention (p<0.001). No significant change was observed in the control group (p=0.1). Also, the mean scores of all constructs of the BASNEF model increased significantly after the intervention compared to those of the control group (p<0.05).
CONCLUSIONS


Family counseling had a positive effect on decreasing the exposure to secondhand smoke at home among a sample of pregnant women. The BASNEF model is useful for implementing educational care programs in these settings.",2019,Four family counseling sessions using the BASNEF model were held for the intervention group while the control group received routine care.,"['Pregnant women', 'pregnant women in Iran', '103 pregnant women exposed to secondhand smoke', 'pregnant women']","['family counselling', 'BASNEF model', 'routine care']",['mean scores of all constructs of the BASNEF model'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}]","[{'cui': 'C0152055', 'cui_str': 'Family counseling'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",103.0,0.0205619,Four family counseling sessions using the BASNEF model were held for the intervention group while the control group received routine care.,"[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Soltani', 'Affiliation': 'Mother and Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Barzegar', 'Affiliation': 'Student Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Sangestani', 'Affiliation': 'Mother and Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Ghodratolah', 'Initials': 'G', 'LastName': 'Roshanaii', 'Affiliation': 'Modeling of Non-CommunicableDiseases Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Maleki', 'Affiliation': 'Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",Tobacco prevention & cessation,['10.18332/tpc/113105']
1981,32411753,"Investigation of nicotinamide as more than an anti-phosphorus drug in chronic hemodialysis patients: a single-center, double-blind, randomized, placebo-controlled trial.","Background


Hyperphosphatemia is a common complication of late-stage chronic kidney disease (CKD). Nicotinamide (NAM) has been reported as an adjunctive therapy for hyperphosphatasemia, but the effect of NAM on fibroblast growth factor 23 (FGF23) and Klotho has rarely been reported.
Methods


We randomly assigned 98 patients who underwent regular hemodialysis to received NAM (0.5-1.5 g per day, or 1-3 tablets per day) or placebo (1-3 tablets per day) as an add-on therapy of calcium-based phosphorus binders in a 1:1 ratio. All enrollments were followed-up for 52 weeks. We investigated the serum phosphorus as the primary outcome and serum FGF23 and Klotho as the secondary outcomes. Abdominal aortic calcification (AAC), which had a good correlation with coronary calcification was also compared between the two groups.
Results


In total, 37 patients in the placebo group and 35 patients in the NAM group completed the 52-week follow-up. Compared with the placebo group, the NAM group showed a significant decrease of serum phosphorus at the 8 th , 12 th , 20 th , 44 th , and 52 nd  week. There was a declining trend of FGF23 and Klotho in both the placebo and NAM groups. Linear mixed models (LMMs) for overall comparisons by repeated measures of analysis of variance (ANOVA) revealed a significant decrease of FGF23 and slower declining rate of Klotho in the NAM group. No significant difference of AAC was detected between the two groups (P=0.805).
Conclusions


NAM can not only further decrease the phosphorus level but also reduce the FGF23 level and slow down the descending rate of Klotho in chronic hemodialysis patients.",2020,"Compared with the placebo group, the NAM group showed a significant decrease of serum phosphorus at the 8 th , 12 th , 20 th , 44 th , and 52 nd  week.","['chronic hemodialysis patients', '98 patients who underwent', 'late-stage chronic kidney disease (CKD', '37 patients in the']","['calcium-based phosphorus binders', 'Nicotinamide (NAM', 'regular hemodialysis to received NAM', 'NAM', 'nicotinamide', 'placebo']","['serum phosphorus', 'phosphorus level', 'Abdominal aortic calcification (AAC', 'FGF23 and Klotho', 'FGF23', 'AAC']","[{'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C1144173', 'cui_str': 'KL protein, human'}]",98.0,0.358814,"Compared with the placebo group, the NAM group showed a significant decrease of serum phosphorus at the 8 th , 12 th , 20 th , 44 th , and 52 nd  week.","[{'ForeName': 'Xiang-Yang', 'Initials': 'XY', 'LastName': 'Liu', 'Affiliation': 'NHC Key Lab of Hormones and Development (Tianjin Medical University), Tianjin Key Lab of Metabolic Diseases, Metabolic Diseases Hospital & Institute of Endocrinology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Jing-Rui', 'Initials': 'JR', 'LastName': 'Yao', 'Affiliation': 'Department of Nephrology, Tianjin Haihe Hospital, Tianjin 300300, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'NHC Key Lab of Hormones and Development (Tianjin Medical University), Tianjin Key Lab of Metabolic Diseases, Metabolic Diseases Hospital & Institute of Endocrinology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Lin-Xin', 'Initials': 'LX', 'LastName': 'Xu', 'Affiliation': 'NHC Key Lab of Hormones and Development (Tianjin Medical University), Tianjin Key Lab of Metabolic Diseases, Metabolic Diseases Hospital & Institute of Endocrinology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Yue-Feng', 'Initials': 'YF', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Tianjin Haihe Hospital, Tianjin 300300, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'NHC Key Lab of Hormones and Development (Tianjin Medical University), Tianjin Key Lab of Metabolic Diseases, Metabolic Diseases Hospital & Institute of Endocrinology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Zhi-Heng', 'Initials': 'ZH', 'LastName': 'Xing', 'Affiliation': 'Department of Radiology, Tianjin Haihe Hospital, Tianjin 300300, China.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Fan', 'Affiliation': 'Department of Nephrology, Tianjin Haihe Hospital, Tianjin 300300, China.'}, {'ForeName': 'Zhong-Hua', 'Initials': 'ZH', 'LastName': 'Qin', 'Affiliation': 'Department of Clinical Laboratory, Tianjin Haihe Hospital, Tianjin 300300, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'NHC Key Lab of Hormones and Development (Tianjin Medical University), Tianjin Key Lab of Metabolic Diseases, Metabolic Diseases Hospital & Institute of Endocrinology, Tianjin Medical University, Tianjin 300070, China.'}]",Annals of translational medicine,['10.21037/atm.2020.03.228']
1982,29035633,The effect of technology assisted therapy for intellectually and visually impaired adults suffering from separation anxiety: Conquering the fear.,"Persons with an intellectual disability (ID) are at risk of developing separation anxiety (SA) and, if left untreated, this can be a risk factor for the development of psychopathology. The effects of an intervention, namely technology assisted therapy for SA (TTSA), were examined on the SA, challenging behavior, psychosocial functioning, and quality of life (QOL) experienced by moderate to mild intellectually and visually disabled adults. This study aimed to determine whether TTSA reduces SA and challenging behavior in persons with ID and visual impairment, and if this results in increased psychosocial functioning and QOL. A pre-experimental within-group design with randomized multiple baselines and staggered intervention start-points was used (n = 6). The variables were monitored with standardized instruments. The frequencies of each participant's use of the technology and the frequency and intensity of their behavior were recorded over time. Results indicate that the SA and challenging behavior experienced by the participants decreased significantly and their psychosocial functioning and QOL increased significantly. The conclusions are that TTSA has the potential to be a valid intervention to address SA in adults with visual and moderate to mild IDs.",2019,"The effects of an intervention, namely technology assisted therapy for SA (TTSA), were examined on the SA, challenging behavior, psychosocial functioning, and quality of life (QOL) experienced by moderate to mild intellectually and visually disabled adults.","['mild intellectually and visually disabled adults', 'intellectually and visually impaired adults suffering from separation anxiety', 'persons with ID and visual impairment', 'Persons with an intellectual disability (ID', 'adults with visual and moderate to mild IDs']","['intervention, namely technology assisted therapy for SA (TTSA', 'technology assisted therapy', 'TTSA']","['behavior, psychosocial functioning, and quality of life (QOL', 'psychosocial functioning and QOL']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0003477', 'cui_str': 'Separation Anxiety Disorder'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3665347', 'cui_str': 'Visual Impairment'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0034380'}]",,0.0220824,"The effects of an intervention, namely technology assisted therapy for SA (TTSA), were examined on the SA, challenging behavior, psychosocial functioning, and quality of life (QOL) experienced by moderate to mild intellectually and visually disabled adults.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hoffman', 'Affiliation': 'a Department of Psychiatry and Mental Health , University of Cape Town , Observatory, Cape Town , South Africa.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Sterkenburg', 'Affiliation': 'b Department of Clinical Child and Family Studies and Amsterdam Public Health Research Institute (APH) , Faculty of Behavior and Movement Sciences , Amsterdam , The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Rensburg', 'Affiliation': 'd School of Psychosocial Behavioral Sciences , North-West University, Potchefstroom Campus , Potchefstroom , South Africa.'}]",Assistive technology : the official journal of RESNA,['10.1080/10400435.2017.1371813']
1983,28971601,Yogurt consumption during pregnancy and preterm delivery in Mexican women: A prospective analysis of interaction with maternal overweight status.,"Preterm delivery is an important cause of perinatal morbidity and mortality, often precipitated by maternal infection or inflammation. Probiotic-containing foods, such as yogurt, may reduce systemic inflammatory responses. We sought to evaluate whether yogurt consumption during pregnancy is associated with decreased preterm delivery. We studied 965 women enrolled at midpregnancy into a clinical trial of prenatal docosahexaenoic acid supplementation in Mexico. Yogurt consumption during the previous 3 months was categorized as ≥5, 2-4, or <2 cups per week. Preterm delivery was defined as delivery of a live infant before 37 weeks gestation. We used logistic regression to evaluate the association between prenatal yogurt consumption and preterm delivery and examined interaction with maternal overweight status. In this population, 25.4%, 34.2%, and 40.4% of women reported consuming ≥5, 2-4, and <2 cups of yogurt per week, respectively. The prevalence of preterm delivery was 8.9%. Differences in preterm delivery were non-significant across maternal yogurt consumption groups; compared with women reporting <2 cups of yogurt per week, those reporting 2-4 cups of yogurt per week had adjusted odds ratio (aOR) for preterm delivery of 0.81 (95% confidence interval, CI [.46, 1.41]), and those reporting ≥5 cups of yogurt per week had aOR of 0.94 (95% CI [.51, 1.72]). The association between maternal yogurt consumption and preterm delivery differed significantly for nonoverweight women compared with overweight women (p for interaction = .01). Compared with nonoverweight women who consumed <2 cups of yogurt per week, nonoverweight women who consumed ≥5 cups of yogurt per week had aOR for preterm delivery of 0.24 (95% CI [.07, .89]). Among overweight women, there was no significant association. In this population, there was no overall association between prenatal yogurt consumption and preterm delivery. However, there was significant interaction with maternal overweight status; among nonoverweight women, higher prenatal yogurt consumption was associated with reduced preterm delivery.",2018,"Differences in preterm delivery were non-significant across maternal yogurt consumption groups; compared with women reporting <2 cups of yogurt per week, those reporting 2-4 cups of yogurt per week had adjusted odds ratio (aOR) for preterm delivery of 0.81 (95% confidence interval, CI [.46, 1.41]), and those reporting ≥5 cups of yogurt per week had aOR of 0.94 (95% CI [.51, 1.72]).","['965 women enrolled at midpregnancy into a clinical trial of prenatal', 'Mexican women']","['docosahexaenoic acid supplementation in Mexico', 'Probiotic-containing foods']","['maternal overweight status', 'maternal yogurt consumption and preterm delivery', 'Yogurt consumption', 'prevalence of preterm delivery', 'prenatal yogurt consumption']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0556102', 'cui_str': 'DHA - Docosahexaenoic acid supplementation'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",965.0,0.127421,"Differences in preterm delivery were non-significant across maternal yogurt consumption groups; compared with women reporting <2 cups of yogurt per week, those reporting 2-4 cups of yogurt per week had adjusted odds ratio (aOR) for preterm delivery of 0.81 (95% confidence interval, CI [.46, 1.41]), and those reporting ≥5 cups of yogurt per week had aOR of 0.94 (95% CI [.51, 1.72]).","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kriss', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Ramakrishnan', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Beauregard', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Varun K', 'Initials': 'VK', 'LastName': 'Phadke', 'Affiliation': 'Division of Infectious Diseases, School of Medicine, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Rivera', 'Affiliation': 'Health and Nutrition Research Center, National Institute of Public Health, Cuernavaca, Morelos, Mexico.'}, {'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12522']
1984,31594635,"Relugolix, a novel oral gonadotropin-releasing hormone antagonist, in the treatment of pain symptoms associated with uterine fibroids: a randomized, placebo-controlled, phase 3 study in Japanese women.","OBJECTIVE


To investigate the efficacy and safety of the oral gonadotropin-releasing hormone receptor antagonist, relugolix, in patients experiencing uterine fibroid-associated pain.
DESIGN


Phase 3, multicenter, randomized, double-blind, placebo-controlled study.
SETTING


Medical centers.
PATIENT(S)


Premenopausal Japanese women (N = 65) experiencing moderate-to-severe uterine fibroid-associated pain with a maximum Numerical Rating Scale (NRS) score of ≥4 were randomized and completed the study.
INTERVENTION(S)


Once-daily 40 mg relugolix (n = 33) or placebo (n = 32) for 12 weeks.
MAIN OUTCOME MEASURE(S)


Primary end point: proportion of patients with a maximum NRS score of ≤1 during the 28-day period before the final dose of study drug. Secondary end points: proportion of patients with no pain (NRS = 0) and percentage of days without pain during the 28-day period before the final dose of study drug; adverse events.
RESULT(S)


More patients receiving relugolix versus placebo achieved a maximum NRS score of ≤1 during the 28-day period before the final dose of study drug (57.6% vs. 3.1%). Similarly, more patients receiving relugolix versus placebo achieved a maximum NRS score of 0 (48.5% vs. 3.1%) and experienced more days without pain (96.4% vs. 71.4%). More patients receiving relugolix versus placebo experienced treatment-emergent adverse events (TEAEs; 87.9% vs. 56.3%); however, the rate of treatment discontinuation was low and not different between groups. Most TEAEs were mild to moderate in intensity. TEAEs (≥10%) included hot flush, metrorrhagia, hyperhidrosis, and menorrhagia, consistent with relugolix's mechanism of action, and viral upper respiratory tract infection.
CONCLUSION(S)


Relugolix improved uterine fibroid-associated pain and was well tolerated.
CLINICAL TRIAL REGISTRATION NUMBERS


NCT02655224.
JAPIC CLINICAL TRIAL INFORMATION


JapicCTI-163127.",2019,"More patients receiving relugolix versus placebo experienced treatment-emergent adverse events (TEAEs; 87.9% vs. 56.3%); however, the rate of treatment discontinuation was low and not different between groups.","['pain symptoms associated with uterine fibroids', 'patients experiencing uterine fibroid-associated pain', 'Japanese women', 'Centers', 'Premenopausal Japanese women (N = 65) experiencing moderate-to-severe uterine fibroid-associated pain with a maximum Numerical Rating Scale (NRS) score of ≥4 were randomized and completed the study']","['gonadotropin-releasing hormone antagonist', 'placebo', 'oral gonadotropin-releasing hormone receptor antagonist, relugolix']","['tolerated', 'hot flush, metrorrhagia, hyperhidrosis, and menorrhagia', 'uterine fibroid-associated pain', 'rate of treatment discontinuation', 'efficacy and safety', 'maximum NRS score', 'proportion of patients with a maximum NRS score', 'proportion of patients with no pain (NRS = 0) and percentage of days without pain', 'treatment-emergent adverse events']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0522259', 'cui_str': 'Hormone antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4521858', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}]","[{'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0025874', 'cui_str': 'Dysfunctional Uterine Bleeding'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.621112,"More patients receiving relugolix versus placebo experienced treatment-emergent adverse events (TEAEs; 87.9% vs. 56.3%); however, the rate of treatment discontinuation was low and not different between groups.","[{'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Osuga', 'Affiliation': 'Department of Obstetrics and Gynecology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Enya', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Osaka, Japan. Electronic address: kazuaki.enya@takeda.com.'}, {'ForeName': 'Kentarou', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hoshiai', 'Affiliation': 'Kindai University, Osaka, Japan.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.07.013']
1985,32123973,"Acute effects of oxytocin in music performance anxiety: a crossover, randomized, placebo-controlled trial.","RATIONALE


Individuals with music performance anxiety (MPA) present physical, behavioral, and cognitive manifestations of anxiety, in addition to information processing deficits, especially in facial emotion recognition (FER).
OBJECTIVES


To assess the effects of a single dose of intranasal oxytocin (24 IU) on FER in a sample of musicians with high and low MPA (primary outcome), as well as indicators of mood/anxiety and self-assessed performance (secondary outcomes).
METHODS


Crossover, randomized, double-blind, placebo-controlled trial involving 43 male musicians with different levels of MPA. Participants completed a static facial emotion recognition task and self-rated mood and performance scales. Data were analyzed using ANOVA 2 × 0 for crossover trials and the Omnibus test (measure of separability between intervention and carryover effects).
RESULTS


Only musicians with high MPA treated with oxytocin had a higher accuracy in the recognition of happiness (p < 0.03; d > 0.72). No effects of oxytocin were found on mood indicators or on self-perceived performance, regardless of MPA level.
CONCLUSIONS


The results indicate possible benefits of the acute treatment with oxytocin in MPA, which may improve the management of this common and disabling condition that affects professional musicians. The appropriate perception of positive feedback may increase confidence and feelings of social acceptance, reducing symptoms associated with the condition. The lack of effects on mood/anxiety and cognition may be explained by the context-dependent characteristic of the effects of oxytocin, since the experiment did not represent an actual situation of social threat.
TRIAL REGISTRATION


Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos): No. RBR-9cph2q.",2020,Only musicians with high MPA treated with oxytocin had a higher accuracy in the recognition of happiness (p < 0.03; d > 0.72).,"['FER in a sample of musicians with high and low MPA (primary outcome', '43 male musicians with different levels of MPA', 'music performance anxiety', 'Individuals with music performance anxiety (MPA']","['placebo', 'oxytocin', 'intranasal oxytocin']","['confidence and feelings of social acceptance', 'static facial emotion recognition task and self-rated mood and performance scales', 'mood/anxiety and self-assessed performance (secondary outcomes', 'recognition of happiness', 'mood indicators or on self-perceived performance, regardless of MPA level']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0458631', 'cui_str': 'Performance anxiety (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]","[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",43.0,0.47072,Only musicians with high MPA treated with oxytocin had a higher accuracy in the recognition of happiness (p < 0.03; d > 0.72).,"[{'ForeName': 'Alini D V', 'Initials': 'ADV', 'LastName': 'Sabino', 'Affiliation': 'Medical School of Ribeirão Preto, São Paulo University, Avenida dos Bandeirantes, 3900, Ribeirão Preto, SP, 14048-900, Brazil.'}, {'ForeName': 'Marcos Hortes N', 'Initials': 'MHN', 'LastName': 'Chagas', 'Affiliation': 'Center for Biological and Health Sciences, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Flávia L', 'Initials': 'FL', 'LastName': 'Osório', 'Affiliation': 'Medical School of Ribeirão Preto, São Paulo University, Avenida dos Bandeirantes, 3900, Ribeirão Preto, SP, 14048-900, Brazil. flaliosorio@gmail.com.'}]",Psychopharmacology,['10.1007/s00213-020-05493-0']
1986,31594912,Oral Care Evaluation to Prevent Oral Mucositis in Estrogen Receptor-Positive Metastatic Breast Cancer Patients Treated with Everolimus (Oral Care-BC): A Randomized Controlled Phase III Trial.,"BACKGROUND


The incidence of oral mucositis (any grade) after everolimus treatment is 58% in the general population and 81% in Asian patients. This study hypothesized that professional oral care (POC) before everolimus treatment could reduce the incidence of everolimus-induced oral mucositis.
MATERIALS AND METHODS


This randomized, multicenter, open-label, phase III study evaluated the efficacy of POC in preventing everolimus-induced mucositis. Patients were randomized into POC and control groups (1:1 ratio) and received everolimus with exemestane. Patients in the POC group underwent teeth surface cleaning, scaling, and tongue cleaning before everolimus initiation and continued to receive weekly POC throughout the 8-week treatment period. Patients in the control group brushed their own teeth and gargled with 0.9% sodium chloride solution or water. The primary endpoint was the incidence of all grades of oral mucositis. We targeted acquisition of 200 patients with a 2-sided type I error rate of 5% and 80% power to detect 25% risk reduction.
RESULTS


Between March 2015 and December 2017, we enrolled 175 women from 31 institutions, of which five did not receive the protocol treatment and were excluded. Over the 8 weeks, the incidence of grade 1 oral mucositis was significantly different between the POC group (76.5%, 62 of 82 patients) and control group (89.7%, 78 of 87 patients;  p  = .034). The incidence of grade 2 (severe) oral mucositis was also significantly different between the POC group (34.6%, 28 of 82 patients) and control group (54%, 47 of 87 patients;  p  = .015). As a result of oral mucositis, 18 (22.0%) patients in the POC group and 28 (32.2%) in the control group had to undergo everolimus dose reduction.
CONCLUSION


POC reduced the incidence and severity of oral mucositis in patients receiving everolimus and exemestane. This might be considered as a treatment option of oral care for patients undergoing this treatment.  Clinical trial identification number : NCT02069093.
IMPLICATIONS FOR PRACTICE


The Oral Care-BC trial that prophylactically used professional oral care (POC), available worldwide, did not show a greater than 25% difference in mucositis. The 12% difference in grade 1 or higher mucositis and especially the ∼20% difference in grade 2 mucositis are likely clinically meaningful to patients. POC before treatment should be considered as a treatment option of oral care for postmenopausal patients who are receiving everolimus and exemestane for treatment of hormone receptor-positive, HER2-negative advanced breast cancer and metastatic breast cancer. However, POC was not adequate for prophylactic oral mucositis in these patients, and dexamethasone mouthwash prophylaxis is standard treatment before everolimus.",2019,"The incidence of grade 2 (severe) oral mucositis was also significantly different between the POC group (34.6%, 28 of 82 patients) and control group (54%, 47 of 87 patients;  p  = .015).","['200 patients with a 2-sided type I error rate of 5% and 80% power to detect 25% risk reduction', '175 women from 31 institutions, of which five did not receive the protocol treatment and were excluded', 'Between March 2015 and December 2017', 'Estrogen Receptor-Positive Metastatic Breast Cancer Patients', 'postmenopausal patients who are receiving', 'patients undergoing this treatment', 'for treatment of hormone receptor-positive, HER2-negative advanced breast cancer and metastatic breast cancer', 'general population and 81% in Asian patients']","['Oral Care Evaluation', 'everolimus with exemestane', 'sodium chloride solution or water', 'Everolimus (Oral Care-BC', 'everolimus and exemestane']","['incidence of everolimus-induced oral mucositis', 'incidence of all grades of oral mucositis', 'mucositis', 'prophylactic oral mucositis', 'grade 2 mucositis', 'oral mucositis', 'incidence of grade 1 oral mucositis', 'Oral Mucositis', 'incidence of grade 2 (severe) oral mucositis', 'grade 1 or higher mucositis', 'incidence and severity of oral mucositis']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0078988', 'cui_str': 'Asians'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",175.0,0.029655,"The incidence of grade 2 (severe) oral mucositis was also significantly different between the POC group (34.6%, 28 of 82 patients) and control group (54%, 47 of 87 patients;  p  = .015).","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Niikura', 'Affiliation': 'Department of Breast and Endocrine Surgery, Tokai University School of Medicine, Tokyo, Japan niikura@is.icc.u-tokai.ac.jp.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Nakatukasa', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Amemiya', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Watanabe', 'Affiliation': 'Department of Breast Surgery, Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Hata', 'Affiliation': 'Department of Dentistry, Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kikawa', 'Affiliation': 'Department of Breast Surgery, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Taniike', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Sachiyo', 'Initials': 'S', 'LastName': 'Mitsunaga', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagami', 'Affiliation': 'Department of Breast and Endocrine Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Moriyasu', 'Initials': 'M', 'LastName': 'Adachi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kondo', 'Affiliation': 'Department of Breast and Endocrine Surgery, Nagoya City University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Shibuya', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Nagoya City University Hospital, Nagoya, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': ""Department of Breast Surgical Oncology, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Naito', 'Affiliation': 'Department of Oral Epidemiology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kashiwabara', 'Affiliation': 'Department of Biostatistics, School of Public Health, the University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Umeda', 'Affiliation': 'Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Yoshihide', 'Initials': 'Y', 'LastName': 'Ota', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Tokai University School of Medicine, Tokyo, Japan.'}]",The oncologist,['10.1634/theoncologist.2019-0382']
1987,28976114,"Economic determinants of breastfeeding in Haiti: The effects of poverty, food insecurity, and employment on exclusive breastfeeding in an urban population.","There is limited and inconsistent empirical evidence regarding the role of economic factors in breastfeeding practices, globally. Studies have found both negative and positive associations between low income and exclusive breastfeeding (EBF). Employment, which should improve household income, may reduce EBF due to separation of mother and infant. In the context of a randomized controlled study of lipid-based complementary feeding in an urban slum in Cap Haitien, Haiti, we examined the economic factors influencing breastfeeding practices using mixed methods. Findings demonstrate relationships between urban context, economic factors, and breastfeeding practices. Poverty, food insecurity, time constraints, and limited social support create challenges for EBF. Maternal employment is associated with lower rates of EBF and less frequent breastfeeding. Extreme food insecurity sometimes leads to increased exclusive breastfeeding among Haitian mothers, what we call ""last resort EBF."" In this case, women practice EBF because they have no alternative food source for the infant. Suggested policies and programs to address economic constraints and promote EBF in this population include maternal and child allowances, quality child care options, and small-scale household urban food production.",2018,"Extreme food insecurity sometimes leads to increased exclusive breastfeeding among Haitian mothers, what we call ""last resort EBF.""","['urban population', 'Haiti', 'Haitian mothers']",['lipid-based complementary feeding'],[],"[{'cui': 'C0041935', 'cui_str': 'Urban Population'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}]",[],,0.0219452,"Extreme food insecurity sometimes leads to increased exclusive breastfeeding among Haitian mothers, what we call ""last resort EBF.""","[{'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Lesorogol', 'Affiliation': 'Brown School, Washington University in St Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Bond', 'Affiliation': 'Brown School, Washington University in St Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Sherlie Jean Louis', 'Initials': 'SJL', 'LastName': 'Dulience', 'Affiliation': 'Brown School, Washington University in St Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Iannotti', 'Affiliation': 'Brown School, Washington University in St Louis, St Louis, Missouri, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12524']
1988,31592887,The Impact of Exposure Therapy on Resting Heart Rate and Heart Rate Reactivity among Active Duty Soldiers with PTSD.,"OBJECTIVE


Posttraumatic stress disorder (PTSD) is linked to poor health, including cardiovascular disease (CVD). These effects may be a result of increased tonic cardiovascular function and cardiovascular reactivity (CVR). Despite PTSD's negative health burden, relatively little is known about whether frontline treatments for PTSD may alleviate cardiovascular risk.
METHODS


The current study was a secondary analysis of a larger intervention study of active duty soldiers with PTSD (N = 104; mean age = 30.6 years, SD = 6.7; 6% women) randomized to an exposure therapy-either prolonged exposure (PE) or virtual reality exposure (VRE)-or a waitlist control condition. We examined change in participants' resting heart rate (HR) and HR reactivity from baseline (prior to randomization) to mid- and post-treatment using residualized change regression models.
RESULTS


The results of the study demonstrated decreased resting HR (B = -5.06, p = .024) and HR reactivity (B = -2.46, p = .005) from baseline to post-treatment for PE and VRE relative to waitlist. Exploratory analyses found that change in resting HR and HR reactivity were not significantly correlated with either self-reported or clinician-rated PTSD symptom change.
CONCLUSIONS


These results suggest that PE and VRE for PTSD may alleviate some cardiovascular health risk associated with PTSD improving cardiovascular functioning.RCT Registration: The study was registered at ClinicalTrials.gov (identifier: NCT01193725).",2019,"The results of the study demonstrated decreased resting HR (B = -5.06, p = .024) and HR reactivity (B = -2.46, p = .005) from baseline to post-treatment for PE and VRE relative to waitlist.","['active duty soldiers with PTSD (N = 104; mean age = 30.6 years, SD = 6.7; 6% women', 'Active Duty Soldiers with PTSD', 'Posttraumatic stress disorder (PTSD']","['RCT Registration', 'Exposure Therapy', 'exposure therapy-either prolonged exposure (PE) or virtual reality exposure (VRE)-or a waitlist control condition']","['resting HR', 'resting HR and HR reactivity', 'Resting Heart Rate and Heart Rate Reactivity', 'tonic cardiovascular function and cardiovascular reactivity (CVR', 'HR reactivity', 'heart rate (HR) and HR reactivity']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}]",,0.0344269,"The results of the study demonstrated decreased resting HR (B = -5.06, p = .024) and HR reactivity (B = -2.46, p = .005) from baseline to post-treatment for PE and VRE relative to waitlist.","[{'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Bourassa', 'Affiliation': 'VA Puget Sound Healthcare System.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Stevens', 'Affiliation': 'VA Puget Sound Healthcare System.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Katz', 'Affiliation': 'VA Puget Sound Healthcare System.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Emory University School of Medicine.'}, {'ForeName': 'Greg M', 'Initials': 'GM', 'LastName': 'Reger', 'Affiliation': 'VA Puget Sound Healthcare System.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Norr', 'Affiliation': 'University of Washington School of Medicine.'}]",Psychosomatic medicine,['10.1097/PSY.0000000000000758']
1989,31593855,Trait anxiety and bystander motivation to defend victims of school bullying.,"INTRODUCTION


School-based bullying is an omnipresent problem, but is less frequent when bystanders are inclined to defend victims. This makes it important to focus on motivation to intervene in bullying.
METHODS


202 students (M age  = 16.44 years, 52% boys) from public Swedish high schools participated in a vignette experiment. Students were randomized to one of two vignettes (victim belonging to/not belonging to ingroup). Self-report measures of motivation to defend and trait anxiety were used.
RESULTS


Participants reported more autonomous motivation when the victim belonged to the ingroup and more extrinsic motivation when the victim did not belong to the ingroup. Trait anxiety interacted with the manipulation: bystanders high in anxiety reported low levels of autonomous motivation when the victim did not belong to the ingroup and low levels of extrinsic motivation when the victim belonged to the ingroup.
CONCLUSIONS


Findings suggest that anti-bullying-programs should focus on how defender motivation is influenced by the way in which victim ingroup status is perceived and address the bystander's level of anxiety as this interacts with such perceptions.",2019,"Trait anxiety interacted with the manipulation: bystanders high in anxiety reported low levels of autonomous motivation when the victim did not belong to the ingroup and low levels of extrinsic motivation when the victim belonged to the ingroup.
","['202 students (M age \u202f=\u202f16.44 years, 52% boys) from public Swedish high schools participated in a vignette experiment', 'to defend victims of school bullying']",[],"['Trait anxiety and bystander motivation', 'Trait anxiety', 'extrinsic motivation', 'autonomous motivation', 'Self-report measures of motivation to defend and trait anxiety']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0392342', 'cui_str': 'Extrinsic motivation (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0156401,"Trait anxiety interacted with the manipulation: bystanders high in anxiety reported low levels of autonomous motivation when the victim did not belong to the ingroup and low levels of extrinsic motivation when the victim belonged to the ingroup.
","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jungert', 'Affiliation': 'Lund University, Box 213, SE-221 00, Lund, Sweden. Electronic address: tomas.jungert@psy.lu.se.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Perrin', 'Affiliation': 'Lund University, Box 213, SE-221 00, Lund, Sweden.'}]",Journal of adolescence,['10.1016/j.adolescence.2019.10.001']
1990,31370958,Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass: Randomized Controlled Trial.,"BACKGROUND


The efficacy of intraoperative corticosteroids to improve outcomes following congenital cardiac operations remains controversial.
OBJECTIVES


The purpose of this study was to determine whether intraoperative methylprednisolone improves post-operative recovery in neonates undergoing cardiac surgery.
METHODS


Neonates undergoing cardiac surgery with cardiopulmonary bypass at 2 centers were enrolled in a double-blind randomized controlled trial of methylprednisolone (30 mg/kg) or placebo after the induction of anesthesia. The primary outcome was a previously validated morbidity-mortality composite that included any of the following events following surgery before discharge: death, mechanical circulatory support, cardiac arrest, hepatic injury, renal injury, or rising lactate level (>5 mmol/l).
RESULTS


Of the 190 subjects enrolled, 176 (n = 81 methylprednisolone, n = 95 placebo) were included in this analysis. A total of 27 (33%) subjects in the methylprednisolone group and 40 (42%) in the placebo group reached the primary study endpoint (odds ratio [OR]: 0.63; 95% confidence interval [CI]: 0.31 to 1.3; p = 0.21). Methylprednisolone was associated with reductions in vasoactive inotropic requirements and in the incidence of the composite endpoint in subjects undergoing palliative operations (OR: 0.38; 95% CI: 0.15 to 0.99; p = 0.048). There was a significant interaction between treatment effect and center. In this analysis, methylprednisolone was protective at 1 center, with an OR: 0.35 (95% CI: 0.15 to 0.84; p = 0.02), and not so at the other center, with OR: 5.13 (95% CI: 0.85 to 30.90; p = 0.07).
CONCLUSIONS


Intraoperative methylprednisolone failed to show an overall significant benefit on the incidence of the composite primary study endpoint. There was, however, a benefit in patients undergoing palliative procedures and a significant interaction between treatment effect and center, suggesting that there may be center or patient characteristics that make prophylactic methylprednisolone beneficial.",2019,Methylprednisolone was associated with reductions in vasoactive inotropic requirements and in the incidence of the composite endpoint in subjects undergoing palliative operations (OR: 0.38; 95% CI: 0.15 to 0.99; p = 0.048).,"['Neonates undergoing cardiac surgery with cardiopulmonary bypass at 2 centers', 'neonates undergoing cardiac surgery', 'Neonates Undergoing Cardiopulmonary Bypass', '190 subjects enrolled, 176 (n\xa0']","['intraoperative methylprednisolone', 'intraoperative corticosteroids', 'placebo', 'methylprednisolone', '81 methylprednisolone, n\xa0=\xa095 placebo', 'Corticosteroid Therapy', 'Methylprednisolone']","['morbidity-mortality composite that included any of the following events following surgery before discharge: death, mechanical circulatory support, cardiac arrest, hepatic injury, renal injury, or rising lactate level (>5\xa0mmol/l', 'vasoactive inotropic requirements']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney (disorder)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}]",190.0,0.752619,Methylprednisolone was associated with reductions in vasoactive inotropic requirements and in the incidence of the composite endpoint in subjects undergoing palliative operations (OR: 0.38; 95% CI: 0.15 to 0.99; p = 0.048).,"[{'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Graham', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina. Electronic address: grahamem@musc.edu.'}, {'ForeName': 'Reneé H', 'Initials': 'RH', 'LastName': 'Martin', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Buckley', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Sinai C', 'Initials': 'SC', 'LastName': 'Zyblewski', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Minoo N', 'Initials': 'MN', 'LastName': 'Kavarana', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Bradley', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Bahaaldin', 'Initials': 'B', 'LastName': 'Alsoufi', 'Affiliation': ""Children's Healthcare of Atlanta and Emory University, Atlanta, Georgia.""}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Mahle', 'Affiliation': ""Children's Healthcare of Atlanta and Emory University, Atlanta, Georgia.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hassid', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Atz', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.05.060']
1991,31722446,Long-term safety and efficacy of mirogabalin in Asian patients with diabetic peripheral neuropathic pain.,"AIMS/INTRODUCTION


Diabetic peripheral neuropathic pain (DPNP) affects the functionality, mood and sleep patterns of patients with diabetes. Mirogabalin, an α 2  δ ligand with a slower dissociation for α 2  δ-1 versus α 2  δ-2 subunits, showed efficacy and safety in a randomized, double-blind, placebo-controlled, 14-week study in Asian patients with DPNP. This open-label extension study evaluated the long-term safety and efficacy of mirogabalin in Asian patients with DPNP.
MATERIAL AND METHODS


This 52-week open-label extension study was carried out in Japan, Korea and Taiwan in patients with DPNP. Patients received mirogabalin, initiated at 5 mg twice daily and increased to a flexible maintenance dosage of 10 or 15 mg twice daily. Adverse events were monitored throughout the study. Patients provided a self-assessment of pain using the Short-Form McGill Pain Questionnaire.
RESULTS


Of the 214 patients who entered the study, 172 (80.4%) completed the extension study. Of 172 patients who completed the study, 149 received the highest dosage of mirogabalin (15 mg twice daily). The most common treatment-emergent adverse events were nasopharyngitis, diabetic retinopathy, peripheral edema, somnolence, diarrhea, increased weight and dizziness. Most treatment-emergent adverse events were mild or moderate in severity. The incidence of treatment-emergent adverse events leading to treatment discontinuation was 13.1%. The visual analog scale and all other Short-Form McGill Pain Questionnaire subscales (sensory score, affective score, total score and present pain intensity) generally decreased over time from baseline until week 52.
CONCLUSIONS


This extension study showed the safety and efficacy of a long-term flexible dosing regimen of mirogabalin 10 or 15 mg twice daily in patients with DPNP.",2020,"The most common treatment-emergent adverse events (TEAEs) were nasopharyngitis, diabetic retinopathy, peripheral edema, somnolence, diarrhea, increased weight, and dizziness.","['Asian Patients with Diabetic Peripheral Neuropathic Pain', 'Asian patients with DPNP', 'Japan, Korea, and Taiwan in patients with DPNP', '172 patients who completed the study, 149 received the highest dosage of', 'patients with diabetes', 'patients with DPNP', '214 patients entered, 172 (80.4%) completed the extension study']","['placebo', 'Mirogabalin', 'mirogabalin']","['self-assessment of pain using the Short-Form McGill Pain Questionnaire (SF-MPQ', 'Adverse events', 'efficacy and safety', 'visual analog scale and all other SF-MPQ subscales (sensory score, affective score, total score, and present pain intensity', 'nasopharyngitis, diabetic retinopathy, peripheral edema, somnolence, diarrhea, increased weight, and dizziness', 'safety and efficacy']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963916', 'cui_str': 'Diabetic peripheral neuropathic pain'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4043827', 'cui_str': 'mirogabalin'}]","[{'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire (assessment scale)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",214.0,0.0258839,"The most common treatment-emergent adverse events (TEAEs) were nasopharyngitis, diabetic retinopathy, peripheral edema, somnolence, diarrhea, increased weight, and dizziness.","[{'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Baba', 'Affiliation': 'Aomori Prefectural Central Hospital, Aomori, Japan.'}, {'ForeName': 'Norimitsu', 'Initials': 'N', 'LastName': 'Matsui', 'Affiliation': 'Clinical Development Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Kuroha', 'Affiliation': 'Clinical Development Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Wasaki', 'Affiliation': 'Asia Development Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Ohwada', 'Affiliation': 'Biostatistics and Data Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13178']
1992,28984033,Two-year follow-up of a postpartum weight loss intervention: Results from a randomized controlled trial.,"We recently reported that a 12-week diet intervention among postpartum women produced a weight loss of 12% after 1 year, compared to 5% in controls. Here, we present 2-year results after 1 year of unsupervised follow-up. In total, 110 women with a self-reported body mass index of ≥27 kg/m 2  at 6-15-week postpartum were randomized to diet group (D-group) or control group (C-group). D-group received a 12-week diet intervention by a dietitian followed by monthly e-mails up to the 1-year follow-up. C-group received a brochure on healthy eating. No contact was provided from 1 to 2 years to either group. Eighty-nine women (81%) completed the 2-year follow-up. Median (1st; 3rd quartile) weight change from 0 to 2 years was -6.9 (-11.0; -2.2) kg in D-group and -4.3 (-8.7; -0.2) kg in C-group. There was no group by time interaction at 2 years (p = .082); however, when women with a new pregnancy between 1 and 2 years were excluded, the interaction became significant (-8.2 vs. -4.6 kg, p = .038). From 1 to 2 years, women in D- and C-group gained 2.5 ± 5.0 kg and 1.1 ± 4.4 kg, respectively (p = .186). Women who gained weight from 1 to 2 years reported a decrease in self-weighing frequency compared to women who maintained or lost weight (p = .008). Both groups achieved clinically relevant 2-year weight loss, but the significant between-group-difference observed at 1 year was not maintained at 2 years in the main analysis. However, when women with a new pregnancy between 1 and 2 years were excluded, a significant weight loss effect was observed also at 2 years.",2018,"There was no group by time interaction at 2 years (p = .082); however, when women with a new pregnancy between 1 and 2 years were excluded, the interaction became significant (-8.2 vs. -4.6 kg, p = .038).","['Eighty-nine women (81%) completed the 2-year follow-up', '110 women with a self-reported body mass index of ≥27\xa0kg/m 2  at 6-15-week postpartum']","['diet intervention by a dietitian followed by monthly e-mails up to the 1-year follow-up', 'postpartum weight loss intervention', 'C-group received a brochure on healthy eating']","['time interaction', 'weight loss', 'weight loss effect', 'self-weighing frequency', 'clinically relevant 2-year weight loss']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",110.0,0.0491479,"There was no group by time interaction at 2 years (p = .082); however, when women with a new pregnancy between 1 and 2 years were excluded, the interaction became significant (-8.2 vs. -4.6 kg, p = .038).","[{'ForeName': 'Ena', 'Initials': 'E', 'LastName': 'Huseinovic', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Bertz', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Hilde Kristin', 'Initials': 'HK', 'LastName': 'Brekke', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Winkvist', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Maternal & child nutrition,['10.1111/mcn.12539']
1993,32412419,A Lower Leg Physical Activity Intervention for Individuals With Chronic Venous Leg Ulcers: Randomized Controlled Trial.,"BACKGROUND


Individuals with venous leg ulcers (VLUs) suffer disproportionately with multiple chronic conditions, are often physically deconditioned, and demonstrate high levels of physical inactivity.
OBJECTIVE


The primary objective of this randomized controlled trial was to establish the feasibility of a mobile health (mHealth) physical activity exercise app for individuals with VLUs to improve lower leg function.
METHODS


In a 6-week study, adults with VLUs were recruited from 2 wound centers in South Carolina, United States, and enrolled if they were aged 18 years or older with impaired functional mobility and an ankle-brachial index between 0.8 and 1.3. Participants were randomized 1:1 to receive evidence-based, phased, nonexertive physical conditioning activities for lower leg function (FOOTFIT) or FOOTFIT+ with an added patient-provider communication feature. The mHealth Conditioning Activities for Lower Leg Function app also provided automated educational and motivational messages and user reports. Foot movement on the VLU-affected leg was tracked by a Bluetooth-enabled triaxial accelerometer. The study was guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to assess the feasibility of reach, adherence, acceptability, implementation, and maintenance.
RESULTS


A total of 24 patients were recruited, enrolled, and randomized in the study. Most patients reported difficulty following the protocol for exercising and using the accelerometer and mobile phone and did not use the provider contact feature. However, all patients were adherent to the 6-week exercise program more than 85% of the time for duration, whereas 33% (8/24) of patients adhered more than 85% for the frequency of performing the exercises. Across the three exercise levels, adherence did not differ between the two groups. Confidence limits around the difference in proportions ranged from -0.4 to 0.7. Providers in FOOTFIT+ were inconsistent in checking participant progress reports because of lack of time from competing work commitments. The technology became outdated quickly, making maintenance problematic. Participants said they would continue to exercise their foot and legs and liked being able to follow along with the demonstrations of each level of exercise provided through the app.
CONCLUSIONS


The findings of this study suggest that despite initial interest in using the app, several components of the program as originally designed had limited acceptability and feasibility. Future refinements should include the use of more modern technology including smaller wearable accelerometers, mobile phones or tablets with larger screens, an app designed with larger graphics, automated reporting for providers, and more engaging user features.
TRIAL REGISTRATION


ClinicalTrials.gov NTC02632695; https://clinicaltrials.gov/ct2/show/NCT02632695.",2020,"Across the three exercise levels, adherence did not differ between the two groups.","['Individuals With Chronic Venous Leg Ulcers', 'Individuals with venous leg ulcers (VLUs) suffer disproportionately with multiple chronic conditions', 'adults with VLUs were recruited from 2 wound centers in South Carolina, United States, and enrolled if they were aged 18 years or older with impaired functional mobility and an ankle-brachial index between 0.8 and 1.3', 'individuals with VLUs', 'A total of 24 patients']","['evidence-based, phased, nonexertive physical conditioning activities for lower leg function (FOOTFIT) or FOOTFIT+ with an added patient-provider communication feature', 'Leg Physical Activity Intervention', 'mobile health (mHealth) physical activity exercise']","['feasibility of reach, adherence, acceptability, implementation, and maintenance', 'Confidence limits']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",24.0,0.0958684,"Across the three exercise levels, adherence did not differ between the two groups.","[{'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Kelechi', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Prentice', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Madisetti', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Vertegel', 'Affiliation': 'Department of Bioengineering, Clemson University, Clemson, SC, United States.'}]",JMIR mHealth and uHealth,['10.2196/15015']
1994,30426323,Age Moderates Link Between Training Effects and Treatment Response to Attention Bias Modification Treatment for Social Anxiety Disorder.,"Attention bias modification treatment (ABMT) aims to reduce anxiety symptoms via practice on computerized attention training tasks. Despite evidence of efficacy, clinical effects appear heterogeneous. More research on ABMT mechanisms and moderators of treatment response is needed. Age is one potentially important moderator, as developmental differences in training effects may impact response. We examined developmental links between ABMT training effects and response in social anxiety disorder (SAD). We pooled data from two randomized controlled trials in treatment-seeking youths and adults with SAD (N = 99) that used identical ABMT methods. We first characterized learning effects associated with the eight-session ABMT training protocol. We then tested whether learning magnitude predicted the clinical (change in SAD symptoms) and cognitive (change in attention bias) responses to treatment. Finally, we tested whether age moderated the association between ABMT learning and treatment response. Results indicate that ABMT was associated with an incremental learning curve during the protocol, and that learning improved with age. Age further moderated the association between learning gains during the ABMT protocol and subsequent reduction in self-reported SAD symptoms, such that this association was stronger with age. These effects were not evident in bias scores or clinician ratings. Finally, pre-treatment SAD symptoms and bias scores predicted ABMT learning gains. This study highlights the links among age, learning processes, and clinical response to ABMT. These insights may inform attempts to increase the clinical efficacy of ABMT for anxiety.",2019,"Age further moderated the association between learning gains during the ABMT protocol and subsequent reduction in self-reported SAD symptoms, such that this association was stronger with age.","['social anxiety disorder (SAD', 'treatment-seeking youths and adults with SAD (N\u2009=\u200999) that used identical ABMT methods', 'Social Anxiety Disorder']","['ABMT', 'Attention bias modification treatment (ABMT', 'Attention Bias Modification Treatment']",['incremental learning curve'],"[{'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.0243176,"Age further moderated the association between learning gains during the ABMT protocol and subsequent reduction in self-reported SAD symptoms, such that this association was stronger with age.","[{'ForeName': 'Rany', 'Initials': 'R', 'LastName': 'Abend', 'Affiliation': 'Section on Development and Affective Neuroscience, National Institute of Mental Health, 9000 Rockville Pike, Bldg. 15K, Bethesda, MD, 20892, USA. rany.abend@nih.gov.'}, {'ForeName': 'Reut', 'Initials': 'R', 'LastName': 'Naim', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Pergamin-Hight', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, 3404D Benjamin Building, College Park, MD, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Pine', 'Affiliation': 'Section on Development and Affective Neuroscience, National Institute of Mental Health, 9000 Rockville Pike, Bldg. 15K, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Bar-Haim', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}]",Journal of abnormal child psychology,['10.1007/s10802-018-0494-7']
1995,32412417,A Mobile App Lifestyle Intervention to Improve Healthy Nutrition in Women Before and During Early Pregnancy: Single-Center Randomized Controlled Trial.,"BACKGROUND


Unhealthy nutrition contributes to the worldwide rising prevalence of noncommunicable diseases. As most adverse reproductive outcomes originate during the periconception period, effective interventions targeting this period are needed. Therefore, we developed the lifestyle intervention Smarter Pregnancy to empower women to adapt a healthy diet prior to conception and during early pregnancy and performed a randomized controlled trial.
OBJECTIVE


The objectives of this trial were to investigate compliance and effectiveness in women using the Smarter Pregnancy program.
METHODS


Women aged between 18 and 45 years who were contemplating pregnancy or <13 weeks pregnant and their male partners living in the urban area of Rotterdam, the Netherlands, were eligible for participation. After baseline screening, the intervention group received personal online coaching based on identified inadequate intakes of vegetables, fruits, and folic acid supplements. The sum of these risk factors was used as a dietary risk score (DRS), ranging from 0 (healthy) to 9 (unhealthy). The control group did not receive coaching. We applied an intention-to-treat principle and used a multivariable linear regression model to evaluate the change in DRS after 24 weeks. Compliance was defined as the percentage of women who completed the screening questionnaire at 24 weeks.
RESULTS


Of women recruited, 81.2% (177/218) completed the program (intervention: 91/218, 83.5%; control: 86/218, 78.9%; P=.95). After 24 weeks, the reduction in DRS of women in the intervention group was significantly larger than in the control group (β=.75, 95% CI 0.18-1.34). This reduction was mainly due to increased vegetable intake (β=.55, 95% CI 0.25-0.86).
CONCLUSIONS


The high compliance and the larger improvements in nutritional behaviors, especially vegetable intake, in women in the intervention group emphasizes the effectiveness of empowering women by using the lifestyle change intervention Smarter Pregnancy.
TRIAL REGISTRATION


Netherlands Trial Register: NL3927; https://www.trialregister.nl/trial/3927.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s12884-017-1228-5.",2020,"This reduction was mainly due to increased vegetable intake (β=.55, 95% CI 0.25-0.86).
","['Women aged between 18 and 45 years who were contemplating pregnancy or <13 weeks pregnant and their male partners living in the urban area of Rotterdam, the Netherlands, were eligible for participation', 'Healthy Nutrition in Women Before and During Early Pregnancy', 'women using the Smarter Pregnancy program']","['control group did not receive coaching', 'personal online coaching based on identified inadequate intakes of vegetables, fruits, and folic acid supplements', 'Mobile App Lifestyle Intervention']","['reduction in DRS', 'vegetable intake', 'compliance and effectiveness', 'dietary risk score (DRS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C5200690', 'cui_str': 'Healthy Nutrition'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.112521,"This reduction was mainly due to increased vegetable intake (β=.55, 95% CI 0.25-0.86).
","[{'ForeName': 'Matthijs R', 'Initials': 'MR', 'LastName': 'van Dijk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Maria P H', 'Initials': 'MPH', 'LastName': 'Koster', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Elsje C', 'Initials': 'EC', 'LastName': 'Oostingh', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Sten P', 'Initials': 'SP', 'LastName': 'Willemsen', 'Affiliation': 'Department of Biostatistics, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Eric A P', 'Initials': 'EAP', 'LastName': 'Steegers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Régine P M', 'Initials': 'RPM', 'LastName': 'Steegers-Theunissen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/15773']
1996,32411907,"Does adding a psychosocial cessation intervention to an existing life-skills and tobacco-prevention program influence the use of tobacco and supari among secondary school students?: Findings from a quasi-experimental trial in Mumbai, India.","INTRODUCTION


This study aimed to test whether school-going adolescents who self-report tobacco and/or supari use are more likely to quit if a school-based psychosocial cessation intervention is added to an existing life-skills and tobacco-prevention program.
METHODS


A quasi-experimental trial with pre-test and post-test 20 weeks after the intervention was conducted with students from low-income families in 12 schools in Mumbai; six schools were randomly assigned to the intervention and the remaining to the comparison condition. Participants were students from grades 7, 8 and 9 who self-reported tobacco and/or supari use. Intervention schools received six sessions of LifeFirst, a psychosocial group-based tobacco cessation intervention program, in addition to SuperArmy, a school-wide life-skills and tobacco-prevention program. Trained counselors facilitated the cessation intervention, which spanned five months. All students in comparison schools received only SuperArmy. The outcome measures were self-reported use of tobacco-only, supari-only, and tobacco plus supari in the past 30 days.
RESULTS


The number of all users decreased by 19.1% in the intervention and 18.7% in the comparison schools at post-test. Although this reduction was significant (p<0.001) within each group, the difference between intervention and comparison schools was not significant. Further segregation by type of product used showed that for tobacco-only users there was a non-significant increase of 1.7% in intervention schools, and a significant 26.2% increase (p<0.001) in the comparison group. Tobacco plus supari use declined in both groups; however, supari-only use fell by 14.8% in the intervention and 32.7% in the comparison schools (p<0.01).
CONCLUSIONS


The combination of a cessation intervention along with the life-skills and tobacco-prevention program appear to have halted tobacco-only use in the intervention group. Future research needs to determine whether students are substituting supari for tobacco and to understand the psychological mechanisms underlying the cessation intervention and the interaction between cessation and prevention-only interventions.",2019,"Tobacco plus supari use declined in both groups; however, supari-only use fell by 14.8% in the intervention and 32.7% in the comparison schools (p<0.01).
","['students from low-income families in 12 schools in Mumbai; six schools', 'Participants were students from grades 7, 8 and 9 who self-reported tobacco and/or supari use', 'school-going adolescents who self-report tobacco and/or supari use']","['six sessions of LifeFirst, a psychosocial group-based tobacco cessation intervention program, in addition to SuperArmy, a school-wide life-skills and tobacco-prevention program', 'psychosocial cessation intervention']","['self-reported use of tobacco-only, supari-only, and tobacco plus supari in the past 30 days', 'number of all users']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0229802,"Tobacco plus supari use declined in both groups; however, supari-only use fell by 14.8% in the intervention and 32.7% in the comparison schools (p<0.01).
","[{'ForeName': 'Nilesh', 'Initials': 'N', 'LastName': 'Chatterjee', 'Affiliation': 'Salaam Bombay Foundation, Mumbai, India.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Gupte', 'Affiliation': 'Narotam Sekhsaria Foundation, Mumbai, India.'}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Mandal', 'Affiliation': 'Salaam Bombay Foundation, Mumbai, India.'}, {'ForeName': 'Tshering', 'Initials': 'T', 'LastName': 'Bhutia', 'Affiliation': 'Salaam Bombay Foundation, Mumbai, India.'}]",Tobacco prevention & cessation,['10.18332/tpc/113355']
1997,32412195,[Locoregional anesthesia in endoscopic surgery of intracerebral hypertensive hemangiomas].,"Introduction


Currently, minimally invasive methods of surgical treatment of hypertensive intracerebral hematomas (ICHs) are actively used. However, anesthetic management of these surgeries are unclear. Moreover, advisability of locoregional anesthesia (LRA) for endoscopic aspiration of hypertensive ICHs has not been studied.
Objective


To analyze application of regional anesthesia in minimally invasive surgery of hypertensive intracerebral hematomas.
Material and methods


Patients were divided into 2 groups. Group 1 included 45 patients who underwent surgery under total intravenous anesthesia with mechanical ventilation (TIVA + mechanical ventilation), group 2 (n=43) - surgery under LRA. The incidence of pneumonia and postoperative outcomes in accordance with the GOS grading system were analyzed depending on the method of anesthesia.
Results


Pneumonia was 3 times more common in the first group (33%) that required prolonged ventilation and tracheostomy. Thus, there were 9 tracheostomies (20%) in the first group. In the second group, one patient required mechanical ventilation on the second postoperative day due to severe chronic obstructive pulmonary disease followed by deterioration of respiratory failure. Tracheostomy was also performed in this case. According to analysis of GOS outcomes, the LRA group was characterized by 4 times lower mortality and 1.5 times greater number of patients with good recovery and moderate disabilities compared with the first group.
Conclusions


LRA is a feasible and effective method for the anesthetic management of minimally invasive surgery in patients with hypertensive ICHs. This approach ensures decrease of mortality rate, increase of good neurological outcomes and reduce pulmonary infectious complications.",2020,"According to analysis of GOS outcomes, the LRA group was characterized by 4 times lower mortality and 1.5 times greater number of patients with good recovery and moderate disabilities compared with the first group.
","['45 patients who underwent', 'minimally invasive surgery of hypertensive intracerebral hematomas', 'intracerebral hypertensive hemangiomas', 'hypertensive intracerebral hematomas (ICHs', 'patients with hypertensive ICHs']","['Locoregional anesthesia', 'regional anesthesia', 'mechanical ventilation', 'surgery under total intravenous anesthesia with mechanical ventilation (TIVA + mechanical ventilation), group 2 (n=43) - surgery under LRA']","['severe chronic obstructive pulmonary disease followed by deterioration of respiratory failure', 'pulmonary infectious complications', 'mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0021870', 'cui_str': 'Intracerebral hematoma'}, {'cui': 'C0442111', 'cui_str': 'Intracerebral'}, {'cui': 'C0018916', 'cui_str': 'Hemangioma'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",45.0,0.0176614,"According to analysis of GOS outcomes, the LRA group was characterized by 4 times lower mortality and 1.5 times greater number of patients with good recovery and moderate disabilities compared with the first group.
","[{'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Tsilina', 'Affiliation': 'City Clinical Emergency Hospital No. 1, Omsk, Russia.'}, {'ForeName': 'Ya A', 'Initials': 'YA', 'LastName': 'Shesterikov', 'Affiliation': 'City Clinical Emergency Hospital No. 1, Omsk, Russia.'}, {'ForeName': 'V G', 'Initials': 'VG', 'LastName': 'Dashyan', 'Affiliation': 'A.I. Evdokimov Moscow State Medical and Dental University, Moscow, Russia.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Petrikov', 'Affiliation': 'A.I. Evdokimov Moscow State Medical and Dental University, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Govorova', 'Affiliation': 'Omsk State Medical University, Omsk, Russia.'}]",Zhurnal voprosy neirokhirurgii imeni N. N. Burdenko,['10.17116/neiro20208402165']
1998,31363948,Proactive outreach tobacco treatment for socioeconomically disadvantaged smokers with serious mental illness.,"Smokers with serious mental illness (SMI) face individual, interpersonal, and healthcare provider barriers to cessation treatment utilization and smoking abstinence. Proactive outreach strategies are designed to address these barriers by promoting heightened contact with smokers and facilitating access to evidence-based treatments. The present study examined the effect of proactive outreach among smokers with SMI (n = 939) who were enrolled in the publicly subsidized Minnesota Health Care Programs (MHCP) and compared this effect to that observed among MHCP smokers without SMI (n = 1382). Relative to usual care, the intervention increased treatment utilization among those with SMI (52.1% vs 40.0%, p = 0.002) and without SMI (39.3% vs 25.4%, p < 0.001). The intervention also increased prolonged smoking abstinence among those with SMI (14.9% vs 9.4%, p = 0.010) and without SMI (17.7% vs 13.6%, p = 0.09). Findings suggest that implementation of proactive outreach within publicly subsidized healthcare systems may alleviate the burden of smoking in this vulnerable population. Trial Registration ClinicalTrials.gov identifier: NCT01123967.",2020,"Relative to usual care, the intervention increased treatment utilization among those with SMI (52.1% vs 40.0%, p = 0.002) and without SMI (39.3% vs 25.4%, p < 0.001).","['Smokers with serious mental illness (SMI', 'smokers with SMI (n\u2009=\u2009939) who were enrolled in the publicly subsidized Minnesota Health Care Programs (MHCP) and compared this effect to that observed among MHCP smokers without SMI (n\u2009=\u20091382', 'socioeconomically disadvantaged smokers with serious mental illness']","['proactive outreach', 'Proactive outreach tobacco treatment']","['treatment utilization', 'prolonged smoking abstinence']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",1382.0,0.0265834,"Relative to usual care, the intervention increased treatment utilization among those with SMI (52.1% vs 40.0%, p = 0.002) and without SMI (39.3% vs 25.4%, p < 0.001).","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Hammett', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research (CCDOR), VA Medical Center (152), Minneapolis VA Health Care System, Minneapolis, MN, USA. hamm0311@umn.edu.'}, {'ForeName': 'Harry A', 'Initials': 'HA', 'LastName': 'Lando', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Darin J', 'Initials': 'DJ', 'LastName': 'Erickson', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Widome', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Brent C', 'Initials': 'BC', 'LastName': 'Taylor', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research (CCDOR), VA Medical Center (152), Minneapolis VA Health Care System, Minneapolis, MN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nelson', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research (CCDOR), VA Medical Center (152), Minneapolis VA Health Care System, Minneapolis, MN, USA.'}, {'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Japuntich', 'Affiliation': 'Hennepin Healthcare Research Institute, Hennepin County Medical Center, Minneapolis, MN, USA.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Fu', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research (CCDOR), VA Medical Center (152), Minneapolis VA Health Care System, Minneapolis, MN, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00083-8']
1999,32412273,Eliminating Leakage Errors in Hyperfine Qubits.,"Population leakage outside the qubit subspace presents a particularly harmful source of error that cannot be handled by standard error correction methods. Using a trapped ^{171}Yb^{+} ion, we demonstrate an optical pumping scheme to suppress leakage errors in atomic hyperfine qubits. The selection rules and narrow linewidth of a quadrupole transition are used to selectively pump population out of leakage states and back into the qubit subspace. Each pumping cycle reduces the leakage population by a factor of ∼3, allowing for an exponential suppression in the number of cycles. We use interleaved randomized benchmarking on the qubit subspace to show that this pumping procedure has negligible side effects on the qubit subspace, bounding the induced qubit memory error by ≤2.0(8)×10^{-5}  per cycle, and qubit population decay to ≤1.4(3)×10^{-7}  per cycle. These results clear a major obstacle for implementations of quantum error correction and error mitigation protocols.",2020,"Each pumping cycle reduces the leakage population by a factor of ∼3, allowing for an exponential suppression in the number of cycles.",[],['trapped ^{171}Yb'],[],[],"[{'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}]",[],,0.0471514,"Each pumping cycle reduces the leakage population by a factor of ∼3, allowing for an exponential suppression in the number of cycles.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hayes', 'Affiliation': 'Honeywell Quantum Solutions, 303 S. Technology Ct. 80021 Broomfield, Colorado, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stack', 'Affiliation': 'Honeywell Quantum Solutions, 303 S. Technology Ct. 80021 Broomfield, Colorado, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bjork', 'Affiliation': 'Honeywell Quantum Solutions, 303 S. Technology Ct. 80021 Broomfield, Colorado, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Potter', 'Affiliation': 'Honeywell Quantum Solutions, 303 S. Technology Ct. 80021 Broomfield, Colorado, USA.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Baldwin', 'Affiliation': 'Honeywell Quantum Solutions, 303 S. Technology Ct. 80021 Broomfield, Colorado, USA.'}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Stutz', 'Affiliation': 'Honeywell Quantum Solutions, 303 S. Technology Ct. 80021 Broomfield, Colorado, USA.'}]",Physical review letters,['10.1103/PhysRevLett.124.170501']
2000,28836373,Evaluation of a smartphone nutrition and physical activity application to provide lifestyle advice to pregnant women: The SNAPP randomised trial.,"Our objective was to evaluate the impact of a smartphone application as an adjunct to face-to-face consultations in facilitating dietary and physical activity change among pregnant women. This multicentre, nested randomised trial involved pregnant women with a body mass index ≥18.5 kg/m 2  , with a singleton pregnancy between 10 and 20 weeks' gestation, and participating in 2 pregnancy nutrition-based randomised trials across metropolitan Adelaide, South Australia. All women participating in the SNAPP trial received a comprehensive dietary, physical activity, and behavioural intervention, as part of the GRoW or OPTIMISE randomised trials. Women were subsequently randomised to either the ""Lifestyle Advice Only Group,"" where women received the above intervention, or the ""Lifestyle Advice plus Smartphone Application Group,"" where women were additionally provided access to the smartphone application. The primary outcome was healthy eating index (HEI) assessed by maternal food frequency questionnaire completed at trial entry, and 28 and 36 weeks' gestation. Analyses were performed using intention-to-treat principles, with statistical significance at p = .05. One hundred sixty-two women participated: 77 allocated to the Lifestyle Advice plus Smartphone Application Group and 85 to the Lifestyle Advice Only Group. Mean difference in HEI score at 28 weeks of pregnancy was 0.01 (CI [-2.29, 2.62]) and at 36 weeks of pregnancy -1.16 (CI [-4.60, 2.28]). There was no significant additional benefit from the provision of the smartphone application in improving HEI score (p = .452). Although all women improved dietary quality across pregnancy, use of the smartphone application was poor. Our findings do not support addition of the smartphone application.",2018,There was no significant additional benefit from the provision of the smartphone application in improving HEI score (p = .452).,"[""kg/m 2  , with a singleton pregnancy between 10 and 20\xa0weeks' gestation, and participating in 2 pregnancy nutrition-based randomised trials across metropolitan Adelaide, South Australia"", 'pregnant women with a body mass index ≥18.5', 'One hundred sixty-two women participated: 77 allocated to the', 'pregnant women', 'All women participating in the SNAPP trial received a']","['comprehensive dietary, physical activity, and behavioural intervention', 'smartphone nutrition and physical activity application', 'Lifestyle Advice Only Group,"" where women received the above intervention, or the ""Lifestyle Advice plus Smartphone Application Group,"" where women were additionally provided access to the smartphone application', 'Lifestyle Advice plus Smartphone Application Group and 85 to the Lifestyle Advice Only Group', 'smartphone application']","['HEI score', 'healthy eating index (HEI) assessed by maternal food frequency questionnaire', 'dietary quality']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0598901', 'cui_str': 'Pregnancy Nutrition'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",162.0,0.179184,There was no significant additional benefit from the provision of the smartphone application in improving HEI score (p = .452).,"[{'ForeName': 'Jodie M', 'Initials': 'JM', 'LastName': 'Dodd', 'Affiliation': 'Discipline of Obstetrics and Gynaecology, and Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Louise', 'Affiliation': 'Discipline of Obstetrics and Gynaecology, and Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Cramp', 'Affiliation': 'Discipline of Obstetrics and Gynaecology, and Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Rosalie M', 'Initials': 'RM', 'LastName': 'Grivell', 'Affiliation': 'Discipline of Obstetrics and Gynaecology, and Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Moran', 'Affiliation': 'Discipline of Obstetrics and Gynaecology, and Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Deussen', 'Affiliation': 'Discipline of Obstetrics and Gynaecology, and Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.'}]",Maternal & child nutrition,['10.1111/mcn.12502']
2001,32411906,"A pilot study assessing the addition of a Quit and Win program to pharmacist-led intensive smoking cessation therapy in a predominantly underserved, minority population.","INTRODUCTION


Quit and Win programs (Q&W) have been shown to improve smoking cessation rates by offering potential rewards to encourage smoking cessation. However, few studies have combined Q&W with intensive smoking cessation programs including behavioral counseling and pharmacotherapy, or studied Q&W in underserved, minority populations. This study was conducted to assess the impact on smoking cessation rates of adding a Q&W to intensive smoking cessation therapy in a largely underserved, minority population.
METHODS


This was a single-center, prospective, open-label controlled study. Current smokers received pharmacist-led behavioral counseling and smoking cessation pharmacotherapy. Intervention group patients who successfully quit (verified by self-report and exhaled carbon monoxide) at 1 month and 3 months post-quit date were entered into a draw for $1000. The control group received the same smoking cessation services, but without a monetary incentive.
RESULTS


Enrollment was 111 patients (N=85 in the intervention group), made up of predominantly underserved (82% had annual household income <$25000), minority (69.1%), and female (58%) patients. Groups were similar except the intervention group had lower educational and income levels, while the control group was more likely to smoke more than 1 pack per day. Quit rates at 3 months were 27% and 19% in the intervention and control groups, respectively (p=0.22). Female gender (OR=2.84; p=0.04) and Fagerström score (OR=0.71; p<0.01) were significant predictors of quitting.
CONCLUSIONS


The addition of Q&W to intensive smoking cessation services increased clinic referrals and numerically improved cessation rates, although this difference was not statistically significant, possibly due to high attrition of the study.",2019,"Quit rates at 3 months were 27% and 19% in the intervention and control groups, respectively (p=0.22).","['111 patients (N=85 in the intervention group), made up of predominantly underserved (82% had annual household income <$25000), minority (69.1%), and female (58%) patients', 'Intervention group patients who successfully quit (verified by self-report and exhaled carbon monoxide) at 1 month and 3 months post-quit date were entered into a draw for $1000']","['same smoking cessation services, but without a monetary incentive', 'Q&W to intensive smoking cessation therapy', 'pharmacist-led behavioral counseling and smoking cessation pharmacotherapy', 'Quit and Win programs (Q&W', 'Quit and Win program to pharmacist-led intensive smoking cessation therapy']","['cessation rates', 'lower educational and income levels', 'smoking cessation rates', 'Fagerström score', 'Quit rates']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C4517664', 'cui_str': '25000'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1095963', 'cui_str': 'Smoking cessation therapy'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0209548,"Quit rates at 3 months were 27% and 19% in the intervention and control groups, respectively (p=0.22).","[{'ForeName': 'Kirk E', 'Initials': 'KE', 'LastName': 'Evoy', 'Affiliation': 'College of Pharmacy, The University of Texas at Austin, Austin, Texas, United States.'}, {'ForeName': 'Kentya H', 'Initials': 'KH', 'LastName': 'Ford', 'Affiliation': 'College of Pharmacy, The University of Texas at Austin, Austin, Texas, United States.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Nduaguba', 'Affiliation': 'College of Pharmacy, The University of Texas at Austin, Austin, Texas, United States.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': 'Department of Pharmacy, University Health System, San Antonio, Texas, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Department of Pharmacy, University Health System, San Antonio, Texas, United States.'}]",Tobacco prevention & cessation,['10.18332/tpc/113356']
2002,31586420,"Secukinumab provides sustained low rates of radiographic progression in psoriatic arthritis: 52-week results from a phase 3 study, FUTURE 5.","OBJECTIVE


To evaluate the effect of secukinumab on radiographic progression through 52 weeks in patients with PsA from the FUTURE 5 study.
METHODS


Patients with active PsA, stratified by prior anti-TNF use (naïve or inadequate response), were randomized to s.c. secukinumab 300 mg load (300 mg), 150 mg load (150 mg), 150 mg no load regimens or placebo at baseline, at weeks 1, 2 and 3 and every 4 weeks starting at week 4. Radiographic progression was assessed by change in van der Heijde-modified total Sharp score (vdH-mTSS; mean of two readers). Statistical analysis used a linear mixed-effects model (random slope) at weeks 24 and 52, and observed data at week 52. Assessments at week 52 included additional efficacy endpoints (non-responders imputation and mixed-effects models for repeated measures) and safety.
RESULTS


The majority (86.6%) of patients completed 52 weeks of treatment. The proportion of patients with no radiographic progression (change from baseline in vdH-mTSS ⩽0.5) was 91.8, 85.2 and 87.2% in 300, 150 and 150 mg no load groups, respectively, at week 52. The change in vdH-mTSS from baseline to week 52 using random slope [mean change (s.e.)] was -0.18 (0.17), 0.11 (0.18) and -0.20 (0.18) in 300, 150 and 150 mg no load groups, respectively; the corresponding observed data [mean change (s.d.)] was -0.09 (1.02), 0.13 (1.39) and 0.21 (1.15). Clinical efficacy endpoints were sustained, and no new or unexpected safety signals were reported through 52 weeks.
CONCLUSION


Secukinumab 300 and 150 mg with or without s.c. loading regimen provided sustained low rates of radiographic progression through 52 weeks of treatment.
TRIAL REGISTRATION


ClinicalTrials.gov, http://clinicaltrials.gov, NCT02404350.",2020,Radiographic progression was assessed by change in van der Heijde-modified total Sharp score (vdH-mTSS; mean of two readers).,"['Patients with active PsA, stratified by prior anti-TNF use (naïve or inadequate response', 'psoriatic arthritis', 'patients with PsA from the FUTURE 5 study']","['placebo', 'Secukinumab', 'secukinumab 300 mg load', 'secukinumab']","['radiographic progression', 'safety', 'Radiographic progression', 'change in vdH-mTSS', 'proportion of patients with no radiographic progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.0869609,Radiographic progression was assessed by change in van der Heijde-modified total Sharp score (vdH-mTSS; mean of two readers).,"[{'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St Joseph Health and University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Robert B M', 'Initials': 'RBM', 'LastName': 'Landewé', 'Affiliation': 'Department of Rheumatology, University of Amsterdam and Atrium Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Proton', 'Initials': 'P', 'LastName': 'Rahman', 'Affiliation': 'Faculty of Medicine, Memorial University, St Johns, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Tahir', 'Affiliation': 'Rheumatology, Whipps Cross Hospital, London, UK.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Singhal', 'Affiliation': 'Southwest Rheumatology, Dallas, TX, USA.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Boettcher', 'Affiliation': 'Rheumazentrum Favoriten, Vienna, Austria.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Navarra', 'Affiliation': ""St Luke's Medical Center, University of Santo Tomas Hospital, Manila, Philippines.""}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Ligozio', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Readie', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Shephard', 'Initials': 'S', 'LastName': 'Mpofu', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Luminita', 'Initials': 'L', 'LastName': 'Pricop', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez420']
2003,28646711,Effect of memantine on C-reactive protein and lipid profiles in bipolar disorder.,"BACKGROUND


Balance in the immune system plays roles in bipolar disorder (BD) and its metabolic co-morbidities. Memantine is an NMDA receptor antagonist with anti-inflammatory effects. However, the effects of memantine adjunct treatment on metabolic status of BD are unclear.
METHODS


During the 12 weeks period, a total of 191 BD patients were enrolled and split into valproate (VPA) + placebo and VPA + memantine (5mg/day) arms. The fasting plasma levels of high-sensitivity C-reactive protein (CRP) and metabolic indices were assessed. BD patients were stratified according to their initial CRP level.
RESULTS


A cut-off value of initial CRP level of 2322ng/mL discriminated the waist circumference in these BD patients after 12-week VPA treatment. In the high CRP (> 2322ng/mL) group, patients in the VPA + memantine arm had a significantly decreased in their CRP (p= 0.009), total cholesterol (p= 0.002), LDL (p= 0.002) levels, BMI (p= 0.001), and waist circumference (p< 0.001), compared to those in the VPA + placebo arm. However, analysis of the low CRP group did not showed the effect.
LIMITATIONS


We recruited BD patients in depressed states and the sample size was relative small. The effects of the fixed dose of memantine on metabolic indices were 12-week follow up in BD patients treated with VPA.
CONCLUSIONS


BD patients with high initial CRP levels receiving memantine adjunct treatment have a reduced risk of inflammation and metabolic imbalance. Prospective studies are needed to confirm the long-term outcome for memantine adjunct therapy in BD patients.",2017,"The effects of the fixed dose of memantine on metabolic indices were 12-week follow up in BD patients treated with VPA.
","['191 BD patients were enrolled and split into', 'BD patients treated with VPA', 'BD patients', 'bipolar disorder']","['VPA + memantine', 'memantine adjunct therapy', 'valproate (VPA) + placebo and VPA + memantine', 'memantine', 'Memantine', 'VPA + placebo']","['LDL', 'waist circumference', 'BMI', 'metabolic indices', 'total cholesterol', 'CRP', 'fasting plasma levels of high-sensitivity C-reactive protein (CRP) and metabolic indices', 'risk of inflammation and metabolic imbalance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",191.0,0.0367067,"The effects of the fixed dose of memantine on metabolic indices were 12-week follow up in BD patients treated with VPA.
","[{'ForeName': 'Hui Hua', 'Initials': 'HH', 'LastName': 'Chang', 'Affiliation': 'Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan; School of Pharmacy, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Po See', 'Initials': 'PS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Addiction Research Center, National Cheng Kung University, Tainan, Taiwan. Electronic address: chenps@mail.ncku.edu.tw.'}, {'ForeName': 'Tzu-Yun', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Addiction Research Center, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Sheng-Yu', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Shiou-Lan', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, School of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'San-Yuan', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Jau-Shyong', 'Initials': 'JS', 'LastName': 'Hong', 'Affiliation': 'Laboratory of Pharmacology and Chemistry, National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, NC, USA.'}, {'ForeName': 'Yen Kuang', 'Initials': 'YK', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Addiction Research Center, National Cheng Kung University, Tainan, Taiwan; Department of Psychiatry, National Cheng Kung University Hospital, Dou-Liou Branch, Yunlin, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Ru-Band', 'Initials': 'RB', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Addiction Research Center, National Cheng Kung University, Tainan, Taiwan.'}]",Journal of affective disorders,['10.1016/j.jad.2017.05.052']
2004,32412700,"Esketamine Nasal Spray for Rapid Reduction of Major Depressive Disorder Symptoms in Patients Who Have Active Suicidal Ideation With Intent: Double-Blind, Randomized Study (ASPIRE I).","OBJECTIVE


To compare esketamine to placebo, each in addition to standard-of-care treatment, for rapidly reducing major depressive disorder symptoms, including suicidal ideation.
METHODS


This phase 3, double-blind, multicenter study (ASPIRE I), conducted between June 2017 and December 2018, enrolled 226 adults having major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria, active suicidal ideation with intent, and need for psychiatric hospitalization. Patients were randomized 1:1 to esketamine 84 mg or placebo nasal spray twice-weekly for 4 weeks, each with comprehensive standard-of-care treatment (initial psychiatric hospitalization and newly initiated or optimized oral antidepressant[s] therapy). Change from baseline to 24 hours post-first dose in Montgomery-Asberg Depression Rating Scale (MADRS) total score (primary endpoint) was analyzed using analysis of covariance (ANCOVA), and change in Clinical Global Impression of Severity of Suicidality Revised version (CGI-SS-r; key secondary endpoint) score was analyzed using ANCOVA on ranks with treatment difference estimated using the Hodges-Lehmann estimate.
RESULTS


Greater improvement in MADRS total score was observed with esketamine + standard-of-care versus placebo + standard-of-care at 24 hours (least-squares mean difference [SE]: -3.8 [1.39]; 95% CI, -6.56 to -1.09; 2-sided P = .006), as well as at earlier (4 hours) and later time points during 4-week double-blind treatment. The difference between groups in the severity of suicidality was not statistically significant (median of treatment difference [95% CI]: 0.0 [-1.00 to 0.00]; 2-sided P = .107). The most common adverse events among esketamine-treated patients were dizziness, dissociation, headache, nausea, and somnolence.
CONCLUSIONS


These findings demonstrate rapid and robust efficacy of esketamine nasal spray in reducing depressive symptoms in severely ill patients with major depressive disorder who have active suicidal ideation with intent.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03039192.",2020,The difference between groups in the severity of suicidality was not statistically significant (median of treatment difference [95% CI]: 0.0 [-1.00 to 0.00]; 2-sided P = .107).,"['severely ill patients with major depressive disorder who have active suicidal ideation with intent', 'June 2017 and December 2018, enrolled 226 adults having major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria, active suicidal ideation with intent, and need for psychiatric hospitalization', 'Patients', 'Who Have Active Suicidal Ideation With Intent']","['placebo', 'esketamine nasal spray', 'esketamine 84 mg or placebo nasal spray twice-weekly for 4 weeks, each with comprehensive standard-of-care treatment (initial psychiatric hospitalization and newly initiated or optimized oral antidepressant[s] therapy', 'Esketamine Nasal Spray']","['severity of suicidality', 'Clinical Global Impression of Severity of Suicidality Revised version (CGI-SS-r; key secondary endpoint) score', 'MADRS total score', 'dizziness, dissociation, headache, nausea, and somnolence', 'Major Depressive Disorder Symptoms', 'Montgomery-Asberg Depression Rating Scale (MADRS) total score', 'depressive symptoms']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0749133', 'cui_str': 'Active suicidal ideation'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0086168', 'cui_str': 'Dissociation - mental defense mechanism'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",226.0,0.482575,The difference between groups in the severity of suicidality was not statistically significant (median of treatment difference [95% CI]: 0.0 [-1.00 to 0.00]; 2-sided P = .107).,"[{'ForeName': 'Dong-Jing', 'Initials': 'DJ', 'LastName': 'Fu', 'Affiliation': 'Director, Neuroscience Clinical Development, Janssen Research and Development, LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ 08560. dfu@its.jnj.com.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, San Diego, California, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Quantitative Sciences, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Lane', 'Affiliation': 'Department of Quantitative Sciences, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Lim', 'Affiliation': 'Department of Quantitative Sciences, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hough', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Husseini', 'Initials': 'H', 'LastName': 'Manji', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, San Diego, California, USA.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Canuso', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m13191']
2005,32413812,Effects of a mindfulness based behavioral intervention for young adults with childhood maltreatment history on hippocampal morphometry: a pilot MRI study with voxel-based morphometry.,"Childhood maltreatment has long lasting impacts on neural development of the hippocampus, which is important for learning and memory. The present study aimed to assess the effects of a mindfulness based intervention on hippocampal morphometry and episodic memory in this population. We administered MRI, psychological questionnaires and an episodic memory task to 21 participants (5 males) before and after a mindfulness-based behavioral intervention, compared to 21 participants (7 males) on the waiting list. Changes in Gray Matter Volume (GMV) in bilateral hippocampi were analyzed with Voxel-Based Morphometry (VBM). One cluster was identified in the right hippocampus with a group by time interaction effect that consisted of 130 contiguous voxels but fell short of significance with full FDR correction (p = 0.077). GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group. Within the mindfulness group, changes in hippocampal GMV were negatively associated with changes in perceived stress and depression severity and positively associated with enhancement in performance accuracy on the episodic memory task. Findings from this pilot study suggest that a mindfulness-based intervention may lead to an increase in partial hippocampal GMV with associated symptom reduction and improvement in episodic memory.",2020,GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group.,"['21 participants (5 males) before and after a', 'young adults with childhood maltreatment history on hippocampal morphometry']","['mindfulness based intervention', 'mindfulness-based behavioral intervention', 'mindfulness based behavioral intervention']","['perceived stress and depression severity', 'GMV', 'hippocampal morphometry and episodic memory', 'episodic memory', 'hippocampal GMV', 'partial hippocampal GMV', 'Gray Matter Volume (GMV']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]",130.0,0.0170544,GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group.,"[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Joss', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Massachusetts General Hospital, USA; Department of Psychiatry, Harvard Medical School, Boston, USA. Electronic address: djoss@mclean.harvard.edu.'}, {'ForeName': 'Sara W', 'Initials': 'SW', 'LastName': 'Lazar', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Teicher', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111087']
2006,28585371,Influences of early child nutritional status and home learning environment on child development in Vietnam.,"Early childhood development plays a key role in a child's future health, educational success, and economic status. However, suboptimal early development remains a global challenge. This study examines the influences of quality of the home learning environment (HOME) and child stunting in the first year of life on child development. We used data collected from a randomized controlled trial of preconceptional micronutrient supplementation in Vietnam (n = 1,458). The Bayley Scales of Infant Development-III were used to assess cognition, language, and motor development domains at 2 years. At 1 year, 14% of children were stunted, and 15%, 58%, and 28% of children lived in poor, medium, and high HOME environments, respectively. In multivariate generalized linear regression models, living in a high HOME environment was significantly associated with higher scores (0.10 to 0.13 SD) in each of the developmental domains. Stunted children scored significantly lower for cognitive, language, and motor development (-0.11 to -0.18), compared to nonstunted children. The negative associations between stunting on development were modified by HOME; the associations were strong among children living in homes with a poor learning environment whereas they were nonsignificant for those living in high-quality learning environments. In conclusion, child stunting the first year of life was negatively associated with child development at 2 years among children in Vietnam, but a high-quality HOME appeared to attenuate these associations. Early interventions aimed at improving early child growth as well as providing a stimulating home environment are critical to ensure optimal child development.",2018,The negative associations between stunting on development were modified by HOME; the associations were strong among children living in homes with a poor learning environment whereas they were nonsignificant for those living in high-quality learning environments.,"['early child nutritional status and home learning environment on child development in Vietnam', 'Vietnam (n\xa0=\xa01,458']","['home learning environment (HOME', 'preconceptional micronutrient supplementation']","['cognitive, language, and motor development', 'cognition, language, and motor development domains']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",,0.0183048,The negative associations between stunting on development were modified by HOME; the associations were strong among children living in homes with a poor learning environment whereas they were nonsignificant for those living in high-quality learning environments.,"[{'ForeName': 'Phuong H', 'Initials': 'PH', 'LastName': 'Nguyen', 'Affiliation': 'International Food Policy Research Institute, Washington, District of Columbia, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'DiGirolamo', 'Affiliation': 'Georgia State University, Atlanta, Georgia, USA.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Gonzalez-Casanova', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Young', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'University of Washington School of Public Health, Seattle, Washington, USA.'}, {'ForeName': 'Son', 'Initials': 'S', 'LastName': 'Nguyen', 'Affiliation': 'Thai Nguyen University of Pharmacy and Medicine, Thai Nguyen, Vietnam.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Martorell', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Ramakrishnan', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12468']
2007,28752645,Effect of pumping pressure on onset of lactation after caesarean section: A randomized controlled study.,"Caesarean section is associated with weaker newborn suction pressure. This nonblinded, randomized trial explored the effect of suction pressures generating by a breast pump on mothers' onset of lactation and milk supply after caesarean section. A high pressure group (-150 mmHg), a low pressure group (-100 mmHg), and a control group (none) were generated under computer random assignment with concealed allocation in 2 tertiary hospitals. The breast pumping began within 2 hr after caesarean operation (6 times a day and 30 min per time) until onset of lactation. The primary outcomes were the timing of onset of lactation, milk supply, and mother's satisfaction in lactation, using both intention-to-treat and per-protocol analyses. The secondary endpoints were the pumping-related pain, nipple injury, and maternal fatigue. All 164 women randomized were included in analysis. The breast pumping at -150 mmHg optimally advanced the timing of the onset of lactation and increased daytime milk supply. The pumping also appeared to boost mothers' confidence in lactation. The results in the per-protocol population (n = 148) were consistent with those of intention-to-treat population (n = 164). However, the pumping aggravated maternal nipple pain and fatigue, though there was no statistical significance. The findings suggest that a higher pumping pressure within the range of normal vaginally born infant suction could promote onset of lactation and milk supply among mothers giving birth by caesarean section. The pumping could also enhance mothers' confidence in breastfeeding.",2018,The results in the per-protocol population (n = 148) were consistent with those of intention-to-treat population (n = 164).,"['All 164 women randomized were included in analysis', ""mothers' onset of lactation and milk supply after caesarean section"", 'lactation after caesarean section']","['pumping pressure', 'suction pressures generating by a breast pump']","['pumping-related pain, nipple injury, and maternal fatigue', 'maternal nipple pain and fatigue', ""timing of onset of lactation, milk supply, and mother's satisfaction in lactation, using both intention-to-treat and per-protocol analyses""]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0022925', 'cui_str': 'Milk Secretion'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C0182541', 'cui_str': 'Breast pump (physical object)'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457424', 'cui_str': 'Nippled (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0423637', 'cui_str': 'Sore nipple (finding)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0022925', 'cui_str': 'Milk Secretion'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",164.0,0.154971,The results in the per-protocol population (n = 148) were consistent with those of intention-to-treat population (n = 164).,"[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Fudan University, Shanghai, China.'}, {'ForeName': 'Yahui', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, Nantong University, Nantong City, Jiangsu Province, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'School of Nursing, Nantong University, Nantong City, Jiangsu Province, China.'}, {'ForeName': 'Lele', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'School of Nursing, Nantong University, Nantong City, Jiangsu Province, China.'}, {'ForeName': 'Mingzhu', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'School of Nursing, Nantong University, Nantong City, Jiangsu Province, China.'}, {'ForeName': 'Xueling', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'School of Nursing, Nantong University, Nantong City, Jiangsu Province, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'School of Nursing, Nantong University, Nantong City, Jiangsu Province, China.'}, {'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Ge', 'Affiliation': 'School of Nursing, Nantong University, Nantong City, Jiangsu Province, China.'}, {'ForeName': 'Haiou', 'Initials': 'H', 'LastName': 'Xia', 'Affiliation': 'School of Nursing, Fudan University, Shanghai, China.'}]",Maternal & child nutrition,['10.1111/mcn.12486']
2008,31567041,Effect of cash incentives on tetanus toxoid vaccination among rural Nigerian women: a randomized controlled trial.,"Tetanus toxoid vaccination is freely available for most women in developing countries, yet maternal and neonatal tetanus are still prevalent in 13 countries, 9 of which are in sub-Saharan Africa. We evaluated whether providing cash incentives increases the uptake of tetanus toxoid vaccination among women of childbearing age in rural northern Nigeria. We randomized amounts of cash incentives to women in three groups: 5 Nigerian naira (C5), 300 naira (C300), and 800 naira (C800) (150 naira = 1 U.S. dollar). Overall, of 2,482 women from 80 villages, 1,803 (72.6%) women successfully received the vaccination (419 of 765 [54.8%] women in C5, 643 of 850 [75.7%] women in C300, and 741 of 867 [85.5%] women in C800). Women in C300 and C800 were significantly more likely to receive the vaccine than women in C5. We further found that transportation costs are one of the significant barriers that prevent women from receiving vaccination at clinics, and that cash incentives compensate for transportation costs unless such costs are large.",2020,Women in C300 and C800 were significantly more likely to receive the vaccine than women in C5.,"['women of childbearing age in rural northern Nigeria', 'women in three groups: 5 Nigerian naira (C5), 300 naira (C300), and 800 naira (C800) (150 naira = 1 U.S. dollar', 'rural Nigerian women', '2,482 women from 80 villages, 1,803 (72.6%) women successfully received the vaccination (419 of 765 [54.8%] women in C5, 643 of 850 [75.7%] women in C300, and 741 of 867 [85.5%] women in C800']","['cash incentives', 'vaccine', 'Tetanus toxoid vaccination']","['uptake of tetanus toxoid vaccination', 'tetanus toxoid vaccination']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1556089', 'cui_str': 'Nigerians (ethnic group)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0562019', 'cui_str': 'dollar (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0305062', 'cui_str': 'Clostridium tetani toxoid antigen, inactivated'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0305062', 'cui_str': 'Clostridium tetani toxoid antigen, inactivated'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",2482.0,0.0926217,Women in C300 and C800 were significantly more likely to receive the vaccine than women in C5.,"[{'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Sato', 'Affiliation': 'Harvard T.H.Chan School of Public Health, Global Health and Population, Boston, MA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Fintan', 'Affiliation': 'Adamawa Satate Primary Healthcare Development Agency, Nigeria.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1672493']
2009,32050951,Effects of different reminder strategies on first-time mammography screening among women in Taiwan.,"BACKGROUND


The study's purpose was to examine the effectiveness of different reminder strategies on first-time free mammography screening among middle-aged women in Taiwan.
METHODS


A quasi-experimental design with random assignment was adopted to divide the participants into three Reminder Strategies groups (mail reminder, telephone reminder, and combined mail and telephone reminders) and one control group. This study recruited 240 eligible middle-aged women, and 205 of them completed the study. Upon the completion of data collection, mail reminders were provided to women of the first group; telephone reminders were provided to the second group; mail followed by telephone reminders were provided to the third group, and the usual postcards were provided to the control group 1 month after the interventions. Two follow-up assessments were conducted 1 and 3 months after the intervention to collect mammography-screening behaviors from all groups.
RESULTS


The findings showed that, compared to the control group, more participants in the intervention groups underwent mammography screening after receiving reminder interventions. Telephone contact as reminder was found to have the most significant influence among the interventions (OR = 5.0556; 95% CI = 2.0422-13.5722).
CONCLUSIONS


Government and healthcare providers are recommended to consider adopting the telephone reminder strategy to encourage women to undergo their first-time mammography screening.",2020,"Telephone contact as reminder was found to have the most significant influence among the interventions (OR = 5.0556; 95% CI = 2.0422-13.5722).
","['women in Taiwan', '240 eligible middle-aged women, and 205 of them completed the study', 'middle-aged women in Taiwan']","['Reminder Strategies groups (mail reminder, telephone reminder, and combined mail and telephone reminders) and one control group', 'mammography screening']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",[],240.0,0.0192227,"Telephone contact as reminder was found to have the most significant influence among the interventions (OR = 5.0556; 95% CI = 2.0422-13.5722).
","[{'ForeName': 'Miao-Ling', 'Initials': 'ML', 'LastName': 'Lin', 'Affiliation': 'Long-Term Care Division, Department of Health, Kaohsiung City Government, No. 2, Sihwei 3rd Road, Lingya District, Kaohsiung City, 80203, Taiwan.'}, {'ForeName': 'Joh-Jong', 'Initials': 'JJ', 'LastName': 'Huang', 'Affiliation': 'Graduate Institute of Gender Studies, Kaohsiung Medical University, No. 100 Shih-Chuan 1st Road, San-Ming District, Kaohsiung, 80708, Taiwan.'}, {'ForeName': 'Shu-Hua', 'Initials': 'SH', 'LastName': 'Li', 'Affiliation': 'Long-Term Care Division, Department of Health, Kaohsiung City Government, No. 2, Sihwei 3rd Road, Lingya District, Kaohsiung City, 80203, Taiwan.'}, {'ForeName': 'Fang-Hsin', 'Initials': 'FH', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Chung Hwa University of Medical Technology, No. 89, Wenhua 1st St., Rende District, Tainan, 71703, Taiwan.'}, {'ForeName': 'Ming-Feng', 'Initials': 'MF', 'LastName': 'Hou', 'Affiliation': 'Graduate Institute of Clinical Medicine, Kaohsiung Medical University, No. 100 Shih-Chuan 1st Road, San-Ming District, Kaohsiung, 80708, Taiwan.'}, {'ForeName': 'Hsiu-Hung', 'Initials': 'HH', 'LastName': 'Wang', 'Affiliation': 'College of Nursing, Kaohsiung Medical University, No. 2, Sihwei 3rd Road, Lingya District, Kaohsiung City, 80203, Taiwan. hhwang@kmu.edu.tw.'}]",BMC health services research,['10.1186/s12913-020-4948-6']
2010,32413673,The effects of testosterone on the physiological response to social and somatic stressors.,"Higher testosterone levels in males have previously been linked to decreased stress reactivity, but in other cases, testosterone has been reported to increase the stress response. We addressed these inconsistencies in a placebo-controlled single-dose testosterone administration study, in which 120 male participants were randomly assigned to undergo a cold-pressor test (CPT, a non-social somatic stressor), a socially evaluated cold-pressor test (SECPT, a social-somatic stressor), or a lukewarm water test (LWT, a non-stressful control condition). Throughout the experiment, blood pressure and interbeat intervals were measured continuously, and saliva samples for hormonal analyses were taken repeatedly at predefined time points. When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies. However, testosterone administration altered this pattern. Compared to placebo, testosterone increased systolic blood pressure during the CPT, whereas the opposite effect was found during the SECPT. Cortisol reactivity was not affected by testosterone administration. The CAG repeat polymorphism of the androgen receptor gene was unrelated to the effects of testosterone on the stress response, but it was correlated with blood pressure across the whole sample. Our findings demonstrate that testosterone's effects on the stress response are dependent on the social context. Testosterone's ability to flexibly influence the response to stressors may be an important mechanism through which the hormone promotes adaptive behavior. Our results are also in line with research showing that testosterone decreases social anxiety and suggest it may help to modulate the effects of stress in socially challenging situations.",2020,"When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies.",['120 male participants'],"['SECPT', 'placebo, testosterone', 'testosterone', 'placebo-controlled single-dose testosterone', 'Testosterone', 'cold-pressor test (CPT, a non-social somatic stressor), a socially evaluated cold-pressor test (SECPT, a social-somatic stressor), or a lukewarm water test (LWT, a non-stressful control condition', 'placebo']","['blood pressure', 'blood pressure and interbeat intervals', 'systolic blood pressure', 'social anxiety', 'Cortisol reactivity']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",120.0,0.036,"When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies.","[{'ForeName': 'Hana H', 'Initials': 'HH', 'LastName': 'Kutlikova', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: hana.kutlikova@univie.ac.at.'}, {'ForeName': 'Jaroslava Babková', 'Initials': 'JB', 'LastName': 'Durdiaková', 'Affiliation': 'Institute of Physiology, Faculty of Medicine, Comenius University in Bratislava, Sasinkova 2, 813 72 Bratislava, Slovakia. Electronic address: durdiakova.jaroslava@fmed.uniba.sk.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Institute of Biomedical Science, FH Joanneum University of Applied Sciences, Eggenberger Allee 13, 8020 Graz, Austria. Electronic address: bernhard.wagner@fh-joanneum.at.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Vlček', 'Affiliation': 'Institute of Clinical and Translational Research, Biomedical Research Center, Slovak Academy of Sciences, Dúbravská cesta 9, 845 05 Bratislava, Slovakia. Electronic address: miroslav.vlcek@savba.sk.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Eisenegger', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria; Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: claus.lamm@univie.ac.at.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Riečanský', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria; Department of Behavioural Neuroscience, Institute of Normal and Pathological Physiology, Centre of Experimental Medicine, Slovak Academy of Sciences, Sienkiewiczova 1, 813 71 Bratislava, Slovakia. Electronic address: igor.riecansky@savba.sk.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104693']
2011,31586368,An Internet-Based Self-Help Intervention for Skin Picking (SaveMySkin): Pilot Randomized Controlled Trial.,"BACKGROUND


In spite of the psychosocial burden and medical risks associated with skin picking disorder, the health care system does not provide sufficient treatment for affected individuals to date. Therefore, an internet-based self-help program for skin picking was developed to offer easily accessible support for this population.
OBJECTIVE


This pilot study evaluated the internet-based self-help program SaveMySkin. The 12-week program is based on cognitive-behavioral therapy and contains comprehensive information and exercises, a daily supportive monitoring system, and dermatological and psychological counseling via internet chat. Primary objectives were the investigation of attitudes and expectations toward the program, intervention effects on skin picking severity, user satisfaction, adherence, and willingness to participate. Secondary outcomes included the feasibility of study procedures, adequacy of assessment instruments, effects on skin picking-related impairment, dimensions of skin picking, and general psychological impairment.
METHODS


A two-arm randomized controlled trial was conducted in a sample of 133 participants (female: 124/133, 93.2%; mean age 26.67 [SD 6.42]) recruited via the internet. Inclusion required a minimum age of 17 years and at least mild skin picking severity. Participants were randomly allocated to the intervention (64/133, 48.1%) or waitlist control group (69/133, 51.9%). All assessments were conducted online and based on self-report.
RESULTS


The willingness to participate was very high in the study, so the initially planned sample size of 100 was exceeded after only 18 days. Participant expectations indicate that they believed the program to be beneficial for them (131/133, 98.5%) and provide a feeling of support (119/133, 89.5%). Reasons for study participation were insufficient outpatient health care (83/133, 62.4%) and flexibility regarding time (106/133, 79.7%) and location (109/133, 82.0%). The post-assessment was completed by 65.4% (87/133) of the sample. The majority of the intervention group who completed the entire post-assessment were satisfied with SaveMySkin (28/38, 74%) and agreed that the program is an appropriate support service (35/38, 92%). On average, participants viewed 29.31 (SD 42.02) pages in the program, and 47% (30/64) of the intervention group used the monitoring at least once a week. In comparison with the control group, the intervention group displayed substantial improvements in the skin picking severity total score (Cohen d=0.67) and especially on the subscale Symptom Severity (Cohen d=0.79). No effects on secondary outcomes were found.
CONCLUSIONS


This study confirms the need for easily accessible interventions for skin picking disorder and the high interest in internet-based self-help within the target population. It provides important insights into the attitudes toward online support and actual user experiences. Participant feedback will be used to further enhance the intervention. Our results point to the preliminary efficacy of SaveMySkin and may lay the foundation for future research into the efficacy and cost-effectiveness of the program in a multicenter clinical trial.
TRIAL REGISTRATION


German Clinical Trial Register DRKS00015236; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00015236.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1016/j.conctc.2018.100315.",2019,"Participant expectations indicate that they believed the program to be beneficial for them (131/133, 98.5%) and provide a feeling of support (119/133, 89.5%).","['Inclusion required a minimum age of 17 years and at least mild skin picking severity', 'a sample of 133 participants (female: 124/133, 93.2%; mean age 26.67 [SD 6.42]) recruited via the internet']","['SaveMySkin', 'waitlist control', 'cognitive-behavioral therapy and contains comprehensive information and exercises, a daily supportive monitoring system, and dermatological and psychological counseling via internet chat', 'internet-based self-help program SaveMySkin', 'Internet-Based Self-Help Intervention for Skin Picking (SaveMySkin']","['feasibility of study procedures, adequacy of assessment instruments, effects on skin picking-related impairment, dimensions of skin picking, and general psychological impairment', 'skin picking severity, user satisfaction, adherence, and willingness to participate', 'flexibility regarding time', 'subscale Symptom Severity', 'skin picking severity total score']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0011625', 'cui_str': 'Agent, Dermatological'}, {'cui': 'C0474178', 'cui_str': 'Psychological counseling'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0946707', 'cui_str': 'Chat'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",133.0,0.0482541,"Participant expectations indicate that they believed the program to be beneficial for them (131/133, 98.5%) and provide a feeling of support (119/133, 89.5%).","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Gallinat', 'Affiliation': 'Center for Psychotherapy Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moessner', 'Affiliation': 'Center for Psychotherapy Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Holger A', 'Initials': 'HA', 'LastName': 'Haenssle', 'Affiliation': 'Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Julia K', 'Initials': 'JK', 'LastName': 'Winkler', 'Affiliation': 'Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Backenstrass', 'Affiliation': 'Institute of Clinical Psychology, Hospital Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'Center for Psychotherapy Research, University Hospital Heidelberg, Heidelberg, Germany.'}]",Journal of medical Internet research,['10.2196/15011']
2012,28399620,"Efficacy and safety of S-acyl glutathione 2% cream vs. placebo against UVB-induced erythema: a randomized, double-blinded clinical trial.","BACKGROUND


Reactive oxygen species have a major role in the UV-induced short- and long-term damage, thus the exogenous supplementation of antioxidant molecules may allow better skin protection. Despite glutathione has pivotal properties in the complex cytoplasmic antioxidant system, its supplementation is hampered by limited transmembrane absorption. Modification of glutathione pharmacokinetic properties via acetylation with long-chain polyunsaturated fatty acid may improve its passage through phospholipidic membranes.
METHODS


This was a single center randomized double-blinded clinical trial, versus placebo, cross-sectional pairwise at time 0. The participants were 10 healthy volunteers with skin phototypes II or III and age ≥18 years interested in performing minimal erythema dose (MED) evaluation performed by photoallergology unit of Division of Dermatology at P. Palagi Hospital, in Florence. Each volunteer underwent UVB phototesting, treating four different areas with increasing UVB doses in four different conditions. One arm was treated as standard procedure (naïve arm), one applying linolenic-glutathione conjugate (Lin-GSH) cream 2% before irradiation (pre-Lin-GSH arm), one with placebo (placebo arm) and one applying Lin-GSH cream 2% (SoloSale Srl, Florence, Italy) after irradiation (post-Lin-GSH arm). The main endpoint was to evaluate efficacy of Lin-GSH cream 2% before UVB irradiation compared with placebo. A secondary endpoint was the evaluation of the same cream applied after irradiation compared to no treatment. Another secondary objective is the evaluation of safety in both conditions. Mean MED was evaluated at distinct conditions. Safety was evaluated reporting all grade 3-4 adverse events up to 30 days after treatment. All volunteers were treated in all four experimental conditions. The pre-Lin-GSH and placebo arms were applied in a double-blind condition for each volunteer. Neither the volunteer nor the investigator executing MED evaluation knew which arm was given Lin-GSH and which one placebo.
RESULTS


Ten volunteers among 12 recruited for the study were correctly randomized and completed all study evaluations. Recruitment went from April 1st, 2016 to May 1st, 2016, up to adequate population number. Mean MED in pre-Lin-GSH arm was superior to mean MED in placebo arm (135±5.53 mJ/cm2 vs. 105±7.64 mJ/cm2, P=0.0003). No difference was observed among mean MED in post-Lin-GSH and naïve arms. No grade 3-4 adverse events were reported.
CONCLUSIONS


Lin-GSH 2% cream seems a safe and effective in producing a significant increase in MED compared with placebo thanks to its antioxidant properties.",2019,"CONCLUSIONS


Lin-GSH 2% cream seems a safe and effective molecule able to exert significant increase in MED compared with placebo thanks to its antioxidant properties.","['All volunteers were treated in all 4 experimental conditions. ', 'against UVB--induced erythema', 'Ten volunteers among 12 recruited for the study', '10 healthy volunteers with skin phototypes II or III and age ≥18 years interested in performing MED evaluation performed by photoallergology unit of Dermatology division, P. Palagi hospital, Florence']","['linolenic-glutathione conjugate (Lin-GSH) cream 2% before irradiation (""Pre Lin-GSH"" arm), one with placebo (""placebo"" arm) and one applying Lin-GSH cream', 'placebo', 'S--acyl glutathione 2% cream vs. placebo', 'Pre Lin-GSH"" and ""Placebo', 'Lin-GSH cream']","['mean MED', 'Mean MED', 'Efficacy and safety', 'Safety']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0075558', 'cui_str': 'BSP-SG'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",10.0,0.453399,"CONCLUSIONS


Lin-GSH 2% cream seems a safe and effective molecule able to exert significant increase in MED compared with placebo thanks to its antioxidant properties.","[{'ForeName': 'Vieri', 'Initials': 'V', 'LastName': 'Grandi', 'Affiliation': 'Unit of Dermatology, Department of Surgery and Translational Medicine, P. Palagi Hospital, University of Florence, Florence, Italy - vieri.grandi@unifi.it.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Milanesi', 'Affiliation': 'Unit of Dermatology, Department of Surgery and Translational Medicine, P. Palagi Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Sessa', 'Affiliation': 'L. Donatelli Section of Pharmacology, Department of Experimental Medicine, L. Vanvitelli University of Campania, Naples, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Gola', 'Affiliation': 'Unit of Dermatology, Department of Surgery and Translational Medicine, P. Palagi Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Cappugi', 'Affiliation': 'Unit of Dermatology, Department of Surgery and Translational Medicine, P. Palagi Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Pimpinelli', 'Affiliation': 'Unit of Dermatology, Department of Surgery and Translational Medicine, P. Palagi Hospital, University of Florence, Florence, Italy.'}]","Giornale italiano di dermatologia e venereologia : organo ufficiale, Societa italiana di dermatologia e sifilografia",['10.23736/S0392-0488.17.05603-6']
2013,28766913,Feasibility and acceptability of a text message intervention used as an adjunct tool by WIC breastfeeding peer counsellors: The LATCH pilot.,"Breastfeeding rates among mothers in the Supplemental Nutrition Program for Women, Infants, and Children (WIC) are lower than for other mothers in the United States. The objective of this study was to test the acceptability and feasibility of the Lactation Advice thru Texting Can Help intervention. Mothers were enrolled at 18-30 weeks gestation from two WIC breastfeeding peer counselling (PC) programmes if they intended to breastfeed and had unlimited text messaging, more than fifth-grade literacy level, and fluency in English or Spanish. Participants were randomized to the control arm (PC support without texting) or the intervention arm (PC support with texting). The two-way texting intervention provided breastfeeding education and support from peer counsellors. Primary outcomes included early post-partum (PP) contact and exclusive breastfeeding (EBF) rates at 2 weeks PP. Feasibility outcomes included text messaging engagement and mother's satisfaction with texting platform. Fifty-eight women were enrolled, 52 of whom were available for intention-to-treat analysis (n = 30 texting, n = 22 control). Contact between mothers and PCs within 48 hr of delivery was greater in the texting group (86.6% vs. 27.3%, p < .001). EBF rates at 2 weeks PP among participants in the texting intervention was 50% versus 31.8% in the control arm (p = .197). Intervention group mothers tended to be more likely to meet their breastfeeding goals (p = .06). Participants were highly satisfied with the Lactation Advice thru Texting Can Help intervention, and findings suggest that it may improve early post-delivery contact and increase EBF rates among mothers enrolled in WIC who receive PC. A large, multicentre trial is feasible and warranted.",2018,EBF rates at 2 weeks PP among participants in the texting intervention was 50% versus 31.8% in the control arm (p = .197).,"['WIC breastfeeding peer counsellors', 'Fifty-eight women were enrolled, 52 of whom were available for intention-to-treat analysis (n\xa0=\xa030 texting, n\xa0=\xa022 control']","['control arm (PC support without texting) or the intervention arm (PC support with texting', 'Supplemental Nutrition Program', 'WIC breastfeeding peer counselling (PC) programmes if they intended to breastfeed and had unlimited text messaging, more than fifth-grade literacy level, and fluency in English or Spanish', 'Lactation Advice thru Texting', 'text message intervention']","['acceptability and feasibility', 'Feasibility and acceptability', 'early post-partum (PP) contact and exclusive breastfeeding (EBF) rates', 'EBF rates', 'Breastfeeding rates', ""text messaging engagement and mother's satisfaction with texting platform""]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205172', 'cui_str': 'More (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0022925', 'cui_str': 'Milk Secretion'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",58.0,0.0943724,EBF rates at 2 weeks PP among participants in the texting intervention was 50% versus 31.8% in the control arm (p = .197).,"[{'ForeName': 'Nurit', 'Initials': 'N', 'LastName': 'Harari', 'Affiliation': 'Chinle Comprehensive Health Care Facility, Indian Health Services, Chinle, Arizona, USA.'}, {'ForeName': 'Marjorie S', 'Initials': 'MS', 'LastName': 'Rosenthal', 'Affiliation': 'National Clinician Scholars Program, Robert Wood Johnson Foundation Clinical Scholars Program, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Bozzi', 'Affiliation': 'Breastfeeding Heritage and Pride Program, Yale New Haven Hospital, New Haven, Connecticut, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Goeschel', 'Affiliation': 'Connecticut WIC Program, Community, Family and Health Equity Section, State of Connecticut Department of Public Health, Hartford, Connecticut, USA.'}, {'ForeName': 'Teshika', 'Initials': 'T', 'LastName': 'Jayewickreme', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Chukwuma', 'Initials': 'C', 'LastName': 'Onyebeke', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Griswold', 'Affiliation': 'Graduate School of Nursing, University of Massachusetts, Worcester, Massachusetts, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Perez-Escamilla', 'Affiliation': 'Yale School of Public Health, New Haven, Connecticut, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12488']
2014,31862436,Communicating health information and improving coordination with primary care (CHIIP): Rationale and design of a randomized cardiovascular health promotion trial for adult survivors of childhood cancer.,"BACKGROUND


Long-term survival for children diagnosed with cancer exceeds 80%. Notably, premature cardiovascular disease has become the leading non-cancer cause of late mortality among these survivors.
METHODS/DESIGN


This randomized controlled trial (RCT; NCT03104543) focuses on adult participants in the Childhood Cancer Survivor Study identified as high risk for ischemic heart disease or heart failure due to their cancer treatment. Participants undergo a home-based evaluation of blood pressure and laboratory tests to determine the prevalence of undiagnosed and/or undertreated hypertension, dyslipidemia, and diabetes. Those with abnormal values are then enrolled in an RCT to test the efficacy of a 12-month personalized, remotely delivered survivorship care plan (SCP) intervention designed to reduce undertreatment of these three target conditions. The intervention approximates a clinical encounter and is based on chronic disease self-management strategies.
RESULTS


With a goal of 750, currently 342 out of 742 eligible participants approached have enrolled (46.1%). Initially, we randomized participants to different recruitment strategies, including shorter approach packets and a tiered consent, but did not find significant differences in participation rates (40.7% to 42.9%; p = .95). Subsequently, slightly greater participation was seen with larger upfront unconditional incentive checks ($50 vs. $25: 50.7% vs. 44.1%; p = .10). Overall, the financial impact of the $50 upfront incentive was cost neutral, and possibly cost-saving, vs. a $25 upfront incentive.
CONCLUSION


The overall study will determine if a National Academy of Medicine-recommended SCP intervention can improve cardiovascular outcomes among long-term survivors of childhood cancer. Modifications to the recruitment strategy may improve participation rates over time.",2020,"Overall, the financial impact of the $50 upfront incentive was cost neutral, and possibly cost-saving, vs. a $25 upfront incentive.
","['Participants undergo a home-based evaluation of blood pressure and laboratory tests to determine the prevalence of undiagnosed and/or undertreated hypertension, dyslipidemia, and diabetes', 'adult participants in the Childhood Cancer Survivor Study identified as high risk for ischemic heart disease or heart failure due to their cancer treatment', '750, currently 342 out of 742 eligible participants approached have enrolled (46.1', 'children diagnosed with cancer exceeds 80', 'adult survivors of childhood cancer']","['survivorship care plan (SCP) intervention', 'primary care (CHIIP', 'Medicine-recommended SCP intervention']","['participation rates', 'cardiovascular outcomes']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0038955'}, {'cui': 'C0178916', 'cui_str': 'Care plan (record artifact)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}]",[],742.0,0.163255,"Overall, the financial impact of the $50 upfront incentive was cost neutral, and possibly cost-saving, vs. a $25 upfront incentive.
","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Chow', 'Affiliation': ""Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America; Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, WA, United States of America. Electronic address: ericchow@uw.edu.""}, {'ForeName': 'Laura-Mae', 'Initials': 'LM', 'LastName': 'Baldwin', 'Affiliation': 'Department of Family Medicine, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Hagen', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Hudson', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, United States of America; Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Gibson', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Kochar', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Nathan', 'Affiliation': 'Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Syrjala', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Taylor', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Tonorezos', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States of America.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Yasui', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Armstrong', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Oeffinger', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105915']
2015,31361307,The GH Axis in Relation to Accepting an Early Macronutrient Deficit and Outcome of Critically Ill Patients.,"CONTEXT


Changes in the GH axis during critical illness resemble fasting in healthy adults and contribute to hypercatabolism, which potentially affects outcome. Accepting macronutrient deficits by withholding parenteral nutrition (PN) during the first week in the intensive care unit (ICU; late PN) reduced complications and accelerated recovery as compared with early use of PN (early PN).
OBJECTIVE


To investigate how late PN affects the GH axis in relation to its clinical outcome benefits.
DESIGN


Preplanned subanalysis of the Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients randomized controlled trial.
PARTICIPANTS


A total of 1128 patients for time-course study, 20 patients investigated for nocturnal GH pulsatility, and 600 patients investigated for muscle weakness, with early PN and late PN patients having comparable baseline characteristics.
INTERVENTION


Withholding PN during the first ICU week (late PN) vs early PN.
MAIN OUTCOME MEASURES


Changes in serum GH, IGF-I, IGF-binding protein (IGFBP) 3, and IGFBP1 concentrations from ICU admission to day 4 or last ICU day for patients with a shorter ICU stay (d4/LD) and association in multivariable analyses with likelihood of earlier live ICU discharge, risk of new infection, and muscle weakness.
RESULTS


Late PN attenuated a rise in serum GH and IGF-I (P < 0.0001), did not affect IGFBP3, and attenuated a decrease in IGFBP1 concentrations from admission to d4/LD (P < 0.0001) as compared with early PN. Late PN decreased nonpulsatile (P = 0.005), but not pulsatile, GH secretion. Adjusting the multivariable models for the observed GH axis alterations increased the independent benefit of late PN for all outcomes. GH axis alterations induced by late PN were independently associated with adverse outcomes (P ≤ 0.03).
CONCLUSION


Accepting macronutrient deficits early during critical illness further suppressed the GH axis, which statistically attenuated its clinical outcome benefits.",2019,"Late PN decreased nonpulsatile (P = 0.005), but not pulsatile, GH secretion.","['healthy adults', 'Adult Critically Ill Patients randomized controlled trial', 'Critically Ill Patients', 'A total of 1128 patients for time-course study, 20 patients investigated for nocturnal GH pulsatility, and 600 patients investigated for muscle weakness, with early PN and late PN patients having comparable baseline characteristics']",[],"['serum GH, IGF-I, IGF-binding protein (IGFBP) 3, and IGFBP1 concentrations from ICU admission', 'GH axis alterations', 'IGFBP1 concentrations', 'earlier live ICU discharge, risk of new infection, and muscle weakness', 'serum GH and IGF']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0577317', 'cui_str': 'Pulsatility (attribute)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0151786', 'cui_str': 'Muscular Weakness'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123707', 'cui_str': 'IGF-Binding Protein 3'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439633', 'cui_str': 'New infection (qualifier value)'}, {'cui': 'C0151786', 'cui_str': 'Muscular Weakness'}]",1128.0,0.104666,"Late PN decreased nonpulsatile (P = 0.005), but not pulsatile, GH secretion.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Van Dyck', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Derese', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vander Perre', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Wouters', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Michaël P', 'Initials': 'MP', 'LastName': 'Casaer', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Hermans', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Van den Berghe', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Vanhorebeek', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Leuven, Belgium.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00842']
2016,31174236,"Randomized trial of ofatumumab and bendamustine versus ofatumumab, bendamustine, and bortezomib in previously untreated patients with high-risk follicular lymphoma: CALGB 50904 (Alliance).","BACKGROUND


This multicenter, randomized phase 2 trial evaluated complete responses (CRs), efficacy, and safety with ofatumumab and bendamustine and with ofatumumab, bendamustine, and bortezomib in patients with untreated, high-risk follicular lymphoma (FL).
METHODS


Patients with grade 1 to 3a FL and either a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2 with 1 lymph node >6 cm or an FLIPI score of 3 to 5 were randomized to arm A (ofatumumab, bendamustine, and maintenance ofatumumab) or to arm B (ofatumumab, bendamustine, bortezomib, and maintenance ofatumumab and bortezomib).
RESULTS


One hundred twenty-eight patients (66 in arm A and 62 in arm B) received treatment. The median age was 61 years, and 61% had disease >6 cm; 29% had an FLIPI score of 2, and 71% had an FLIPI score of 3 to 5. In arm A, 86% completed induction, and 64% completed maintenance. In arm B, 66% and 52% completed induction and maintenance, respectively. Dose modifications were required in 65% and 89% in arms A and B, respectively. Clinically significant grade 3 to 4 toxicities included neutropenia (A, 36%; B, 31%), nausea/vomiting (A, 0%; B, 8%), diarrhea (A, 5%; B, 11%), and sensory neuropathy (A, 0%; B, 5%). The estimated CR rates were 62% (95% confidence interval [CI], 50%-74%) and 60% (95% CI, 47%-72%) in arms A and B, respectively (P = .68). With a median follow-up of 3.3 years, the estimated 2-year progression-free survival (PFS) and overall survival (OS) rates were 80% and 97%, respectively, for arm A and 76% and 91%, respectively, for arm B.
CONCLUSIONS


The CR rates, PFS, and OS were not improved with the addition of bortezomib to ofatumumab and bendamustine in patients with high-risk FL. Although grade 3 to 4 toxicities were similar, more patients treated with bortezomib required dose modifications and early discontinuation.",2019,"Clinically significant grade 3 to 4 toxicities included neutropenia (A, 36%; B, 31%), nausea/vomiting (A, 0%; B, 8%), diarrhea (A, 5%; B, 11%), and sensory neuropathy (A, 0%; B, 5%).","['patients with high-risk FL', 'previously untreated patients with high-risk follicular lymphoma: CALGB 50904 (Alliance', 'Patients with grade 1 to 3a FL and either a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2 with 1 lymph node >6\xa0cm or an FLIPI score of 3 to 5 were randomized to', 'One hundred twenty-eight patients (66 in arm A and 62 in arm B) received treatment', 'patients with untreated, high-risk follicular lymphoma (FL']","['arm A (ofatumumab, bendamustine, and maintenance ofatumumab) or to arm B (ofatumumab, bendamustine, bortezomib, and maintenance ofatumumab and bortezomib', 'bortezomib', 'ofatumumab and bendamustine versus ofatumumab, bendamustine, and bortezomib']","['sensory neuropathy', 'nausea/vomiting', 'FLIPI score', 'CR rates, PFS, and OS', 'complete responses (CRs), efficacy, and safety with ofatumumab and bendamustine and with ofatumumab, bendamustine, and bortezomib', 'toxicities included neutropenia', 'estimated 2-year progression-free survival (PFS) and overall survival (OS) rates', 'diarrhea', 'estimated CR rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C4040298', 'cui_str': 'Follicular Lymphoma International Prognostic Index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}]","[{'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",128.0,0.200143,"Clinically significant grade 3 to 4 toxicities included neutropenia (A, 36%; B, 31%), nausea/vomiting (A, 0%; B, 8%), diarrhea (A, 5%; B, 11%), and sensory neuropathy (A, 0%; B, 5%).","[{'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': 'Department of Hematology and Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Mei-Yin', 'Initials': 'MY', 'LastName': 'Polley', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Travis J', 'Initials': 'TJ', 'LastName': 'Dockter', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': 'Department of Clinical Pathology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wagner-Johnston', 'Affiliation': 'Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Christian', 'Affiliation': 'Comprehensive Cancer Center, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Atkins', 'Affiliation': 'Southeast Clinical Oncology Research Consortium, NCI Community Oncology Research Program, Winston-Salem, North Carolina.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Department of Medicine and Meyer Cancer Center, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri.'}]",Cancer,['10.1002/cncr.32289']
2017,31591119,"Safety, tolerability and pharmacokinetics of oral nafithromycin (WCK4873) after single or multiple doses and effects of food on single-dose bioavailability in healthy adult subjects.","Nafithromycin (WCK 4873), a novel lactone-ketolide, was administered to healthy adult subjects in 2 randomized, double-blind, placebo-controlled, Phase 1 studies. In the first-in-human study, single-ascending oral doses of nafithromycin (100 to 1200 mg) were administered to subjects under fasted or fed condition, with effects of food on bioavailability of nafithromycin studied at the dose levels of 400 and 800 mg. In the second study, multiple-ascending oral doses of 600, 800, or 1000 mg of nafithromycin were administered once daily for 7 days under a fed condition. Nafithromycin was generally well tolerated at all doses. No serious or severe adverse events were observed. The mean maximum plasma concentration (C max ) ranged from 0.099 to 1.742 mg/L, and the area under the concentration-time curve from time zero to time  t  (AUC 0- t  ) ranged from 0.54 to 22.53 h⋅mg/L. Nafithromycin plasma AUC 0- t  increased approximately 1.2-fold under fed compared to fasted condition. In the multiple-dose study, the Day 7 nafithromycin C max  ranged from 1.340 to 2.987 mg/L and the AUC over the final dosing interval (AUC 0-24 ) ranged from 13.48 to 43.46 h⋅mg/L. The steady state was achieved after 3 days for the 600 mg and 800 mg dose cohorts and after 4 days for the 1000 mg cohort. Under both single- and multiple-dosing regimens, plasma exposure to nafithromycin appeared to increase more than dose-proportionally. Nafithromycin showed moderate accumulation on Day 7 of dosing. The human pharmacokinetic profile, safety and tolerability data support further development of nafithromycin.",2019,"The mean maximum plasma concentration (C max ) ranged from 0.099 to 1.742 mg/L, and the area under the concentration-time curve from time zero to time  t  (",['healthy adult subjects'],"['Nafithromycin (WCK 4873), a novel lactone-ketolide', 'Nafithromycin', 'oral nafithromycin (WCK4873', 'nafithromycin', 'placebo']","['mean maximum plasma concentration (C max ', 'Safety, tolerability and pharmacokinetics', 'No serious or severe adverse events', 'Nafithromycin plasma AUC 0- t']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C4705606', 'cui_str': 'nafithromycin'}, {'cui': 'C4705607', 'cui_str': 'WCK 4873'}, {'cui': 'C0022947', 'cui_str': 'Lactones'}, {'cui': 'C1449860', 'cui_str': 'Ketolides'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4705606', 'cui_str': 'nafithromycin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",,0.0402603,"The mean maximum plasma concentration (C max ) ranged from 0.099 to 1.742 mg/L, and the area under the concentration-time curve from time zero to time  t  (","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Iwanowski', 'Affiliation': 'Wockhardt Bio AG, Zug, Switzerland.'}, {'ForeName': 'Ashima', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Wockhardt Ltd., Mumbai, India.'}, {'ForeName': 'Mugdha', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Wockhardt Ltd., Mumbai, India.'}, {'ForeName': 'Anasuya', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Wockhardt Ltd., Mumbai, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Chavan', 'Affiliation': 'Wockhardt Ltd., Mumbai, India.'}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Yeole', 'Affiliation': 'Wockhardt Ltd., Mumbai, India.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Friedland', 'Affiliation': ""Wockhardt's Morton Grove Pharmaceuticals Inc., Morton Grove, Illinois, USA dfriedland@mgp-online.com.""}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01253-19']
2018,31521917,"Compared to an active control condition, in persons with multiple sclerosis two different types of exercise training improved sleep and depression, but not fatigue, paresthesia, and intolerance of uncertainty.","BACKGROUND


In persons with multiple sclerosis (MS), physical activity favorably impacts on psychological well-being. The aims of the present study were to investigate the influence of physical activity on depression, fatigue, sleep, paresthesia, and personality traits (intolerance of uncertainty), and to explore, if endurance training or coordinative training are superior to an active control condition.
METHODS


92 female individuals with MS (mean age: 37.36 years; mean EDSS: 2.43) took part in this intervention study. Participants were randomly assigned either to endurance training, coordinative training, or to an active control condition. At baseline, 4 weeks, and 8 weeks later at the end of the study, participants completed questionnaires on sleep, depression, fatigue, paresthesia and intolerance of uncertainty. Exercise training interventions took place three times/week for 45 min/session. Participants in the active control condition also met with the same duration and frequency.
RESULTS


Sleep complaints and symptoms of depression decreased over time, but more so in the exercising groups, compared to the active control group. No changes over time and between groups were observed for fatigue, paresthesia, and intolerance of uncertainty.
CONCLUSIONS


Both endurance and coordinative exercising had the potential to favorably impact on some aspects of cognitive-emotional processing, while also an active control condition appeared to have a positive impact.",2019,"Both endurance and coordinative exercising had the potential to favorably impact on some aspects of cognitive-emotional processing, while also an active control condition appeared to have a positive impact.","['Participants in the active control condition also met with the same duration and frequency', 'persons with multiple sclerosis', '92 female individuals with MS (mean age: 37.36 years; mean EDSS: 2.43) took part in this intervention study', 'persons with multiple sclerosis (MS']","['endurance training or coordinative training', 'Exercise training interventions', 'endurance training, coordinative training, or to an active control condition', 'exercise training']","['Sleep complaints and symptoms of depression', 'fatigue, paresthesia, and intolerance of uncertainty', 'sleep, depression, fatigue, paresthesia and intolerance of uncertainty', 'depression, fatigue, sleep, paresthesia, and personality traits (intolerance of uncertainty', 'sleep and depression, but not fatigue, paresthesia, and intolerance of uncertainty']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0233849', 'cui_str': 'Personality finding'}]",92.0,0.0149164,"Both endurance and coordinative exercising had the potential to favorably impact on some aspects of cognitive-emotional processing, while also an active control condition appeared to have a positive impact.","[{'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Health Institute, and Sleep Disorders Research Center, Kermanshah, Iran; Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Razazian', 'Affiliation': 'Kermanshah University of Medical Sciences, Neurology Department, Kermanshah, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Farnia', 'Affiliation': 'Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Health Institute, and Sleep Disorders Research Center, Kermanshah, Iran. Electronic address: vfarnia@kums.ac.ir.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Alikhani', 'Affiliation': 'Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Health Institute, and Sleep Disorders Research Center, Kermanshah, Iran.'}, {'ForeName': 'Faezeh', 'Initials': 'F', 'LastName': 'Tatari', 'Affiliation': 'Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Health Institute, and Sleep Disorders Research Center, Kermanshah, Iran.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Health Institute, and Sleep Disorders Research Center, Kermanshah, Iran; University of Basel, Department of Sport, Exercise, and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2019.07.032']
2019,30094611,Development of the Utrecht Score for clavicle fractures: a short and complete clavicle score with patient-reported and objective measures.,"PURPOSE


The purpose of this study was to develop a clavicle-specific questionnaire with patient-reported and objective measures.
METHODS


The present study used data of DASH and Constant scores from a previously performed randomized-controlled trial comparing plate and intramedullary pin fixation of clavicle fractures. Exploratory factor analysis was used to identify the most relevant items and the underlying structure of the questionnaires. To optimize the applicability to patients with a clavicle fracture, the selected items were reformulated. If relevant themes were underexposed, an additional question was added.
RESULTS


Based on the scree plot of eigenvalues and the parallel analysis, a seven-factor model with good factorability was constructed. Using exploratory factor analysis, 13 patient-reported and 2 objective measurements were identified. The internal consistency of the selected questions was excellent. An additional question was added to cover complaints relating to direct pressure on the clavicle and implants.
CONCLUSION


The Utrecht Score for clavicle fractures is a compact yet complete tool that was developed to assess functional outcome specifically in patients with a clavicle fracture, consisting of patient-reported and objective measures. After external validation, the USC can be used for research purposes or clinical follow-up during rehabilitation in patients with a clavicle fracture.",2019,"The Utrecht Score for clavicle fractures is a compact yet complete tool that was developed to assess functional outcome specifically in patients with a clavicle fracture, consisting of patient-reported and objective measures.",['patients with a clavicle fracture'],['plate and intramedullary pin fixation of clavicle fractures'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle (disorder)'}]","[{'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C2732619', 'cui_str': 'Intramedullary'}, {'cui': 'C0175718', 'cui_str': 'Bone Pins'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle (disorder)'}]",[],,0.039454,"The Utrecht Score for clavicle fractures is a compact yet complete tool that was developed to assess functional outcome specifically in patients with a clavicle fracture, consisting of patient-reported and objective measures.","[{'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Hulsmans', 'Affiliation': 'Department of Surgery, Diakonessenhuis Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Ferree', 'Affiliation': 'Department of Surgery, Diakonessenhuis Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Marijn', 'Initials': 'M', 'LastName': 'Houwert', 'Affiliation': 'Utrecht Traumacenter, Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Dijkgraaf', 'Affiliation': 'Clinical Research Unit, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Egbert Jan', 'Initials': 'EJ', 'LastName': 'Verleisdonk', 'Affiliation': 'Department of Surgery, Diakonessenhuis Utrecht, Utrecht, The Netherlands. ejverleisdonk@gmail.com.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van Heijl', 'Affiliation': 'Department of Surgery, Diakonessenhuis Utrecht, Utrecht, The Netherlands.'}]",European journal of trauma and emergency surgery : official publication of the European Trauma Society,['10.1007/s00068-018-0979-7']
2020,31021890,Randomized Controlled Trial: Split-dose and Same-day Large Volume Bowel Preparation for Afternoon Colonoscopy Have Similar Quality of Preparation.,"GOALS


We compare bowel cleanliness in patients taking same-day versus split-dose 4-L polyethylene glycol laxative for afternoon colonoscopy. Secondary objectives included patient satisfaction, adverse effects and patient tolerability.
BACKGROUND


Afternoon colonoscopies have been associated with inadequate bowel preparation and lower adenoma detection rates. Same-day (morning) or split-dosing of the laxative have improved preparation quality but differences between these options are unclear.
MATERIALS AND METHODS


Single-center prospective randomized endoscopist blinded trial. Patients aged 18 years and above prescribed 4-L polyethylene glycol for colonoscopy were randomized into same-day or split-dose preparation. Preparation quality was assessed using the Ottawa Bowel Preparation Scale. Patient satisfaction and side effects was collected using a questionnaire. Intention-to-treat and per-protocol analysis were performed.
RESULTS


A total of 300 patients (158 split-dose, 142 same-day) were evaluated. No statistically significant difference was seen on total Ottawa score among the groups (P=0.47) or by individual colonic segments in intent-to-treat and per-protocol analysis. Patients in split-dose group were more likely to complete the entire preparation (P=0.01) but reported more sleep loss (P=0.001). The same-day preparation group reported higher incidence of vomiting (P=0.036). Patients ingesting bowel preparation ≥7 hours before colonoscopy had higher total Ottawa scores (P=0.001).
CONCLUSIONS


There were no differences in quality of preparation in patients taking same-day versus split-dose preparation for afternoon colonoscopy. Those receiving same-day preparation were less likely to lose sleep but more likely to have emesis. These differences should be considered when selecting a bowel preparation regimen.",2019,No statistically significant difference was seen on total Ottawa score among the groups (P=0.47) or by individual colonic segments in intent-to-treat and per-protocol analysis.,"['patients taking same-day versus', '300 patients (158 split-dose, 142 same-day) were evaluated', 'Patients aged 18 years and above prescribed 4-L polyethylene glycol for colonoscopy']","['Split-dose and Same-day Large Volume Bowel Preparation for Afternoon Colonoscopy', 'split-dose 4-L polyethylene glycol laxative']","['Preparation quality', 'sleep loss', 'incidence of vomiting', 'quality of preparation', 'total Ottawa scores', 'Patient satisfaction and side effects', 'total Ottawa score', 'patient satisfaction, adverse effects and patient tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0235161', 'cui_str': 'Sleep loss'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",300.0,0.231474,No statistically significant difference was seen on total Ottawa score among the groups (P=0.47) or by individual colonic segments in intent-to-treat and per-protocol analysis.,"[{'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Castro', 'Affiliation': 'Department of Gastroenterology, Cleveland Clinic Florida, Weston.'}, {'ForeName': 'Baker', 'Initials': 'B', 'LastName': 'Al-Khairi', 'Affiliation': 'Department of Internal Medicine, Blake Medical Center, Bradenton, FL.'}, {'ForeName': 'Harjinder', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Department of Gastroenterology, Cleveland Clinic Florida, Weston.'}, {'ForeName': 'Mosaab', 'Initials': 'M', 'LastName': 'Mohameden', 'Affiliation': 'Department of Gastroenterology, Cleveland Clinic Florida, Weston.'}, {'ForeName': 'Kanwarpreet', 'Initials': 'K', 'LastName': 'Tandon', 'Affiliation': 'Department of Internal Medicine, Blake Medical Center, Bradenton, FL.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Lopez', 'Affiliation': 'Digestive Diseases Institute, Cleveland Clinic Ohio, Cleveland, OH.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001213']
2021,30644312,"The selective orexin-2 receptor antagonist seltorexant improves sleep: An exploratory double-blind, placebo controlled, crossover study in antidepressant-treated major depressive disorder patients with persistent insomnia.","BACKGROUND


Insomnia is common in patients with major depressive disorder. Although antidepressants improve mood, insomnia often persists as a result of physiological hyperarousal. The orexin-2 receptor is increasingly being recognized as a new target for the treatment of persistent insomnia in major depressive disorder .
AIM


This exploratory study investigated the effects of seltorexant on objective sleep parameters and subjective depressive symptoms in antidepressant treated major depressive disorder patients with persistent insomnia.
METHODS


Twenty male and female patients received a single dose of 10, 20, 40 mg seltorexant and placebo with a washout period of seven days in a double-blind four-way crossover study. Effects on latency to persistent sleep, total sleep time and sleep efficiency were assessed with polysomnography. Subjective changes in mood were explored by the Quick Inventory of Depressive Symptomatology Self-Report. Safety was recorded and suicidal ideation and behavior were assessed with the Columbia Suicide Severity Rating Scale.
RESULTS


Latency to persistent sleep was significantly shorter for all doses of seltorexant compared to placebo. Placebo least square mean was 61.05 min with least square mean ratios treatment/placebo (80% confidence interval) of 0.32 (0.24-0.44), 0.15 (0.11-0.2) and 0.17 (0.12-0.23) 19.69, 9.2, 10.15 for 10, 20 and 40 mg seltorexant respectively, (all p<0.001). Total sleep time was significantly longer for all doses of seltorexant compared to placebo. Sleep efficiency was significantly improved. The Quick Inventory of Depressive Symptomatology Self-Report demonstrated a trend to mood-improvement for the 40 mg group.
CONCLUSIONS


Seltorexant showed a statistically significant, dose-dependent decrease in latency to persistent sleep, and increase in total sleep time and sleep efficiency combined with a tendency toward subjectively improved mood.",2019,"Seltorexant showed a statistically significant, dose-dependent decrease in latency to persistent sleep, and increase in total sleep time and sleep efficiency combined with a tendency toward subjectively improved mood.","['Twenty male and female patients', 'antidepressant-treated major depressive disorder patients with persistent insomnia', 'antidepressant treated major depressive disorder patients with persistent insomnia', 'patients with major depressive disorder']","['seltorexant and placebo', 'placebo', 'Placebo', 'seltorexant']","['objective sleep parameters and subjective depressive symptoms', 'latency to persistent sleep', 'suicidal ideation and behavior', 'Total sleep time', 'Sleep efficiency', 'Latency to persistent sleep', 'Columbia Suicide Severity Rating Scale', 'latency to persistent sleep, total sleep time and sleep efficiency', 'sleep', 'total sleep time and sleep efficiency']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0393758', 'cui_str': 'Persistent insomnia (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}]",20.0,0.14284,"Seltorexant showed a statistically significant, dose-dependent decrease in latency to persistent sleep, and increase in total sleep time and sleep efficiency combined with a tendency toward subjectively improved mood.","[{'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Brooks', 'Affiliation': '1 Clinical Pharmacology, Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Gabriël E', 'Initials': 'GE', 'LastName': 'Jacobs', 'Affiliation': '1 Clinical Pharmacology, Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Boer', 'Affiliation': '2 Neuroscience Development, Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Justine M', 'Initials': 'JM', 'LastName': 'Kent', 'Affiliation': '3 Sunovion, Fort Lee, NJ, USA.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Nueten', 'Affiliation': '2 Neuroscience Development, Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'van Amerongen', 'Affiliation': '1 Clinical Pharmacology, Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Zuiker', 'Affiliation': '1 Clinical Pharmacology, Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Kezic', 'Affiliation': '4 Quantitative Sciences, Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Remy', 'Initials': 'R', 'LastName': 'Luthringer', 'Affiliation': '5 Minerva Neurosciences, Waltham, MA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van der Ark', 'Affiliation': '2 Neuroscience Development, Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Joop Ma', 'Initials': 'JM', 'LastName': 'van Gerven', 'Affiliation': '1 Clinical Pharmacology, Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Drevets', 'Affiliation': '6 Neuroscience Development, Janssen Research and Development, San Diego, CA, USA.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881118822258']
2022,31587813,"Peripartum Management of Gestational Diabetes Using a Digital Health Care Service: A Pilot, Randomized Controlled Study.","PURPOSE


The prevalence of gestational diabetes mellitus (GDM) is increasing, and multifaceted interventions are effective in the management of GDM. This study aimed to develop and evaluate a model for the management of GDM with the use of mobile health care.
METHODS


This was a prospective, randomized controlled pilot study. A total of 21 patients who were diagnosed with GDM during 24-28 weeks of gestation were randomly divided into a conventional management (CM) group (n = 10) and a mobile management (MM) group (n = 11). The CM group received conventional GDM management and could freely use the mobile health care application. The MM group received mobile health care services, including tailored mobile coaching. After delivery, obstetric outcomes were collected, and 75-g oral glucose tolerance test was performed at 5-12 weeks postpartum.
FINDINGS


Baseline characteristics, including glycosylated hemoglobin (HbA 1c ), were not significantly different between the 2 groups. No statistically significant differences were found in rates between the 2 groups for (1) neonate large for gestational age and (2) cesarean section at the time of delivery. No significant difference was found in HbA 1c  between the 2 groups after delivery. However, postpartum homeostatic model assessment insulin resistance, body mass index, weight, and percentage of body fat were significantly lower in the MM group.
IMPLICATIONS


The MM group had no significant difference in glycemic index compared with the CM group. However, the MM group had effective weight control and improved insulin resistance after delivery. This study indicated that mobile health care services could be an efficient GDM management tool. ClinicalTrials.gov identifier: NCT03838380.",2019,No statistically significant differences were found in rates between the 2 groups for (1) neonate large for gestational age and (2) cesarean section at the time of delivery.,"['21 patients who were diagnosed with GDM during 24-28 weeks of gestation', 'gestational diabetes mellitus (GDM', 'Gestational Diabetes Using a Digital Health Care Service']","['mobile health care services, including tailored mobile coaching', 'conventional management (CM) group (n\xa0=\xa010) and a mobile management (MM', 'conventional GDM management']","['glycemic index', 'neonate large for gestational age and (2) cesarean section', 'postpartum homeostatic model assessment insulin resistance, body mass index, weight, and percentage of body fat', 'effective weight control and improved insulin resistance', 'HbA 1c', '75-g oral glucose tolerance test', 'glycosylated hemoglobin (HbA 1c ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}]","[{'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1848395', 'cui_str': 'Large for gestational age'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen (regime/therapy)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0465857,No statistically significant differences were found in rates between the 2 groups for (1) neonate large for gestational age and (2) cesarean section at the time of delivery.,"[{'ForeName': 'Ji-Hee', 'Initials': 'JH', 'LastName': 'Sung', 'Affiliation': 'Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Da Young', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyoung Pil', 'Initials': 'KP', 'LastName': 'Min', 'Affiliation': 'Huraypositive Inc., Sinsa-dong, Gangnam-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Cheol-Young', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: cydoctor@chol.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.09.005']
2023,31858754,Comparison of Operator Workloads Associated with the Single-unit Anyfusion® Pump and the Changeover from a Syringe Pump to an Infusion Pump.,"BACKGROUND


A changeover from a syringe pump to an infusion pump may transiently interrupt drug administration and result in medication errors. A newly developed infusion device (Anyfusion®) that combines the functions of an infusion pump and a syringe pump in a single unit was recently commercialized. This study compared the operator workloads associated with the Anyfusion® pump and with the conventional method using two infusion devices (a syringe pump and an infusion pump).
METHODS


This was a prospective, randomized, crossover-designed simulation study using an imitation arm with an intravascular line. We compared the two methods in terms of total execution time, total number of button clicks, and subjective difficulty using a numerical rating scale with a score from 0 (extremely easy) to 10 (extremely difficult).
RESULTS


Twenty-two nurses successfully performed both interventions according to the allocated sequence. Total execution times did not differ between the two methods (129.5 ± 23.2 seconds for the conventional method vs. 121.2 ± 24.3 seconds for the Anyfusion® method;  P  = 0.244), although the total number of clicks was significantly fewer using the Anyfusion® than the conventional method (median [interquartile range]: 10.0 [9.0-12.0] vs. 21.0 [20.0-25.0], respectively;  P  < 0.001). Participants rated the Anyfusion® method as easier than the conventional method (1.7 ± 1.2 vs. 3.6 ± 1.6;  P  < 0.001, respectively).
CONCLUSION


The introduction of Anyfusion® lessened the workload of practitioners required by the changeover process, which might reduce the risk of medication errors and subsequent patient harm.
TRIAL REGISTRATION


Clinical Research Information Service Identifier: KCT0004172.",2019,"Total execution times did not differ between the two methods (129.5 ± 23.2 seconds for the conventional method vs. 121.2 ± 24.3 seconds for the Anyfusion® method;  P  = 0.244), although the total number of clicks was significantly fewer using the Anyfusion® than the conventional method (median [interquartile range]: 10.0 [9.0-12.0] vs. 21.0 [20.0-25.0], respectively;  P  < 0.001).",[],"['Operator Workloads', 'imitation arm with an intravascular line']","['total number of clicks', 'Total execution times', 'total execution time, total number of button clicks, and subjective difficulty using a numerical rating scale']",[],"[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0453985', 'cui_str': 'Button, device (physical object)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0222045'}]",22.0,0.148363,"Total execution times did not differ between the two methods (129.5 ± 23.2 seconds for the conventional method vs. 121.2 ± 24.3 seconds for the Anyfusion® method;  P  = 0.244), although the total number of clicks was significantly fewer using the Anyfusion® than the conventional method (median [interquartile range]: 10.0 [9.0-12.0] vs. 21.0 [20.0-25.0], respectively;  P  < 0.001).","[{'ForeName': 'Jeong Jin', 'Initials': 'JJ', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Duk Kyung', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. dikei@hanmail.net.'}, {'ForeName': 'Kwan Young', 'Initials': 'KY', 'LastName': 'Hong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Won', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ka Young', 'Initials': 'KY', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",Journal of Korean medical science,['10.3346/jkms.2019.34.e314']
2024,32412872,"Investigation of the effects of veterinarians' attire on ratings of trust, confidence, and comfort in a sample of pet owners in Canada.","OBJECTIVE


To examine companion animal owners' perceptions of appropriate veterinarian attire and investigate potential associations between a veterinarian's attire and clients' ratings of trust in, confidence in, and comfort with a veterinarian.
SAMPLE


449 pet owners.
PROCEDURES


Participants were randomly assigned to complete a questionnaire containing photos of a male or female model veterinarian photographed in 8 attire types (formal attire, white dress shirt with black pants, white casual shirt with khaki pants, surgical scrubs, white casual shirt with jeans, surgical scrub top with jeans, surgical scrub top with khaki pants, and white laboratory coat with khaki pants). Participants were asked to rate their trust in, confidence in, and comfort with the pictured individual on a response scale of 1 (low) to 7 (high), rank photos according to their preferences for attire, and provide input on the importance of attire and other appearance-related subjects. Attire and gender of photographed individual and participant demographics were investigated for associations with trust, confidence, and comfort scores.
RESULTS


Most (317/445 [71%]) respondents indicated veterinarians' attire was important. Attire type was significantly associated with respondents' trust, confidence, and comfort scores. Model veterinarian gender and participant education level were also associated with trust and comfort scores.
CONCLUSIONS AND CLINICAL RELEVANCE


Veterinarians' attire is a form of nonverbal communication that is likely to inform clients' first impressions and may influence clients' trust in, confidence in, and comfort with a veterinarian. Veterinary personnel and veterinary management should consider how attire and general appearance represent staff members or their practice.",2020,"Attire type was significantly associated with respondents' trust, confidence, and comfort scores.","['SAMPLE\n\n\n449 pet owners', 'sample of pet owners in Canada', 'Participants']","[""veterinarians' attire"", 'questionnaire containing photos of a male or female model veterinarian photographed in 8 attire types (formal attire, white dress shirt with black pants, white casual shirt with khaki pants, surgical scrubs, white casual shirt with jeans, surgical scrub top with jeans, surgical scrub top with khaki pants, and white laboratory coat with khaki pants']","['ratings of trust, confidence, and comfort']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0242856', 'cui_str': 'Veterinarian'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0453917', 'cui_str': 'Shirt'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0425488', 'cui_str': 'Rapid shallow breathing'}, {'cui': 'C2936698', 'cui_str': 'Scrubbing, Surgical'}, {'cui': 'C0453932', 'cui_str': 'Jeans'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0405637,"Attire type was significantly associated with respondents' trust, confidence, and comfort scores.","[{'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Coe', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': ""O'Connor"", 'Affiliation': ''}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Pizzolon', 'Affiliation': ''}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Hester', 'Affiliation': ''}, {'ForeName': 'Leandra J', 'Initials': 'LJ', 'LastName': 'Nogueira Borden', 'Affiliation': ''}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Haley', 'Affiliation': ''}]",Journal of the American Veterinary Medical Association,['10.2460/javma.256.11.1268']
2025,31577923,Health Status After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.,"BACKGROUND


In patients with severe aortic stenosis (AS) at low surgical risk, treatment with transcatheter aortic valve replacement (TAVR) results in lower rates of death, stroke, and rehospitalization at 1 year compared with surgical aortic valve replacement; however, the effect of treatment strategy on health status is unknown.
OBJECTIVES


This study sought to compare health status outcomes of TAVR versus surgery in low-risk patients with severe AS.
METHODS


Between March 2016 and October 2017, 1,000 low-risk patients with AS were randomized to transfemoral TAVR using a balloon-expandable valve or surgery in the PARTNER 3 (Placement of Aortic Transcatheter Valves) trial. Health status was assessed at baseline and 1, 6, and 12 months using the KCCQ (Kansas City Cardiomyopathy Questionnaire), SF-36 (Short Form-36 Health Survey), and EQ-5D (EuroQoL). The primary endpoint was change in KCCQ-OS (KCCQ Overall Summary) score over time. Longitudinal growth curve modeling was used to compare changes in health status between treatment groups over time.
RESULTS


At 1 month, TAVR was associated with better health status than surgery (mean difference in KCCQ-OS 16.0 points; p < 0.001). At 6 and 12 months, health status remained better with TAVR, although the effect was reduced (mean difference in KCCQ-OS 2.6 and 1.8 points respectively; p < 0.04 for both). The proportion of patients with an excellent outcome (alive with KCCQ-OS ≥75 and no significant decline from baseline) was greater with TAVR than surgery at 6 months (90.3% vs. 85.3%; p = 0.03) and 12 months (87.3% vs. 82.8%; p = 0.07).
CONCLUSIONS


Among low-risk patients with severe AS, TAVR was associated with meaningful early and late health status benefits compared with surgery.",2019,"At 1 month, TAVR was associated with better health status than surgery (mean difference in KCCQ-OS 16.0 points; p<0.001).","['Between 3/2016 and 10/2017, 1000 low-risk', 'Low-Risk Patients with Aortic Stenosis', 'patients with severe aortic stenosis (AS) at low surgical risk, treatment with', 'low-risk patients with severe AS']","['transcatheter aortic valve replacement (TAVR', 'Transcatheter vs. Surgical Aortic Valve Replacement', 'transfemoral TAVR using a balloon-expandable valve or surgery', 'TAVR vs. surgery']","['health status', 'Health status', 'KCCQ-Overall Summary (KCCQ-OS) score', 'Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-36 and EQ-5D']","[{'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",1000.0,0.0652372,"At 1 month, TAVR was associated with better health status than surgery (mean difference in KCCQ-OS 16.0 points; p<0.001).","[{'ForeName': 'Suzanne J', 'Initials': 'SJ', 'LastName': 'Baron', 'Affiliation': ""Lahey Hospital and Medical Center, Burlington, Massachusetts; Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri. Electronic address: suzanne.j.baron@lahey.org.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Magnuson', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Edwards LifeSciences, Irvine, California.'}, {'ForeName': 'Kaijun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri.""}, {'ForeName': 'Khaja', 'Initials': 'K', 'LastName': 'Chinnakondepalli', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mack', 'Affiliation': 'Baylor Scott and White Healthcare, Plano, Texas.'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'Marcus Heart and Vascular Center, Piedmont Heart Institute, Atlanta, Georgia.'}, {'ForeName': 'Susheel', 'Initials': 'S', 'LastName': 'Kodali', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Makkar', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Herrmann', 'Affiliation': 'Hospital of University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Kapadia', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Vasilis', 'Initials': 'V', 'LastName': 'Babaliaros', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Mathew R', 'Initials': 'MR', 'LastName': 'Williams', 'Affiliation': 'New York University Langone Medical Center, New York, New York.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Kereiakes', 'Affiliation': 'Christ Hospital Heart and Vascular Center, Cincinnati, Ohio.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Zajarias', 'Affiliation': 'Washington University School of Medicine, Barnes-Jewish Hospital, St. Louis, Missouri.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Alu', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Webb', 'Affiliation': ""St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Smith', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City, Kansas City, Missouri.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.007']
2026,28025862,Maternal plasma cholesterol and duration of pregnancy: A prospective cohort study in Ghana.,"Low plasma cholesterol may be associated with preterm birth; however, results are mixed and limited primarily to high-income countries. Our objective was to determine whether maternal plasma lipid concentrations are associated with pregnancy duration. We performed a nested cohort (n = 320) study of pregnant Ghanaian women enrolled in a randomized controlled trial. Total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol, and triglyceride concentrations were analyzed in plasma at ≤20and 36 weeks gestation as continuous variables and also categorized into low, referent, or high (<10th, 10th-90th, >90th percentile). At ≤20 weeks, plasma lipid concentrations were not associated with pregnancy duration. At 36 weeks, total cholesterol and triglyceride concentrations were not associated with pregnancy duration. Higher HDL-C at 36 weeks was associated with a longer pregnancy duration (adjusted β-coefficient ± standard error: 0.05 ± 0.02 days mg -1  /dL, p = .02); pregnancy duration was 5.9 ± 2.0 (mean ± standard error) days shorter among women with low HDL-C compared with the referent group (10th-90th percentile) (p = .02) and 8.6 ± 2.6 days shorter when compared with the high HDL-C group (p = .003). Pregnancy duration was 4.9 ± 2.1 days longer among women with low low-density lipoprotein cholesterol at 36 weeks gestation when compared with the referent group (p = .051). Our data suggest that low HDL-C in the third trimester of pregnancy is associated with a shorter duration of pregnancy in this study population but do not support the hypothesis that low total cholesterol is associated with a shorter pregnancy duration.",2017,days shorter among women with low HDL-C compared with the referent group (10th-90th percentile) (p = .02) and 8.6 ± 2.6 days shorter when compared with the high HDL-C group (p = .003).,"['Ghana', 'nested cohort (n\xa0=\xa0320) study of pregnant Ghanaian women enrolled']",[],"['maternal plasma lipid concentrations', 'Total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol, and triglyceride concentrations', 'plasma lipid concentrations', 'total cholesterol and triglyceride concentrations', 'Pregnancy duration', 'longer pregnancy duration', 'Maternal plasma cholesterol and duration of pregnancy', 'pregnancy duration', 'density lipoprotein cholesterol']","[{'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0337834', 'cui_str': 'Ghanaians (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}]",320.0,0.297929,days shorter among women with low HDL-C compared with the referent group (10th-90th percentile) (p = .02) and 8.6 ± 2.6 days shorter when compared with the high HDL-C group (p = .003).,"[{'ForeName': 'Brietta M', 'Initials': 'BM', 'LastName': 'Oaks', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Laugero', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Adu-Afarwuah', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Legon, Ghana.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lartey', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Legon, Ghana.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Vosti', 'Affiliation': 'Department of Agricultural and Resource Economics, University of California, Davis, California, USA.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Department for Paediatrics and Centre for Child Health Research, University of Tampere School of Medicine and Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12418']
2027,28149157,"Effects of human chorionic gonadotropin combined with clomiphene on Serum E 2 , FSH, LH and PRL levels in patients with polycystic ovarian syndrome.","OBJECTIVE


Effects of human chorionic gonadotropin combined with clomiphene on serum E 2 , FSH, LH and PRL levels in patients with polycystic ovarian syndrome were analyzed.
METHODS


90 patients with polycystic ovarian syndrome treated from January 2015 to March 2016 were randomly and evenly divided into control group and observation group. Patients in the control group were only treated with clomiphene. On the basis of the treatment in control group, human chorionic gonadotropin was added in the treatment of observation group. The changes of E 2 , FSH, LH, PRL levels were compared between two groups before and after the treatment. Clinical curative effects of patients in the two groups was evaluated. Adverse reactions during treatment in two groups were observed and recorded. The incidence of adverse reactions was calculated.
RESULTS


Serum E 2 , FSH, LH and PRL levels in the two groups decreased significantly after treatment compared with that before treatment. The difference is statistical significant ( P  < 0.05). After the treatment, E 2 , FSH, LH and PRL levels in the observation group were lower than that in the control group and the difference is statistical significant ( P  < 0.05). Total effective rate was 64.44% in the control group and 93.33% in the observation group. There were statistically significant difference in clinical curative effects in the two groups ( P  < 0.05). Different degrees of adverse reactions were found in both groups during treatment, such as nausea, vomiting, anorexia, liver dysfunction. There were 2 cases of nausea, 2 cases of vomiting, 3 cases of anorexia and 1 case of liver dysfunction from the 45 patients in control group. The total incidence of adverse reactions was 17.78% (8/45). There were 1 case of nausea, 1 case of vomiting, 1 case of anorexia and no liver dysfunction from the 45 patients in observation group. The total incidence of adverse reactions was 6.67% (3/45). The total incidence of adverse reactions in the observation group was significantly higher than that in the control group and the difference was not statistically significant ( P  > 0.05).
CONCLUSION


Combined use of human chorionic gonadotropin can significantly reduce serum E 2 , FSH, LH and PRL levels, improve clinical curative effects and reduce the incidence of adverse reactions. Human chorionic gonadotropin has high application value on the treatment of polycystic ovary syndrome.",2017,"RESULTS


Serum E 2 , FSH, LH and PRL levels in the two groups decreased significantly after treatment compared with that before treatment.","['patients with polycystic ovarian syndrome', '90 patients with polycystic ovarian syndrome treated from January 2015 to March 2016', 'polycystic ovary syndrome']","['clomiphene', 'Human chorionic gonadotropin', 'human chorionic gonadotropin', 'human chorionic gonadotropin combined with clomiphene']","['Serum E 2 , FSH, LH and PRL levels', 'Clinical curative effects', 'total incidence of adverse reactions', 'Adverse reactions', 'nausea, 1 case of vomiting, 1 case of anorexia and no liver dysfunction', 'serum E 2 , FSH, LH and PRL levels', 'adverse reactions', 'liver dysfunction', 'serum E 2 , FSH, LH and PRL levels, improve clinical curative effects', 'clinical curative effects', 'incidence of adverse reactions', 'changes of E 2 , FSH, LH, PRL levels', 'Total effective rate', 'nausea', 'nausea, vomiting, anorexia, liver dysfunction', 'FSH, LH and PRL levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",90.0,0.0191395,"RESULTS


Serum E 2 , FSH, LH and PRL levels in the two groups decreased significantly after treatment compared with that before treatment.","[{'ForeName': 'Huang', 'Initials': 'H', 'LastName': 'Yonggang', 'Affiliation': 'Reproductive Medicine Center, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xiaosheng', 'Affiliation': 'Reproductive Medicine Center, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China.'}, {'ForeName': 'Huang', 'Initials': 'H', 'LastName': 'Zhaoxia', 'Affiliation': 'Reproductive Medicine Center, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yilu', 'Affiliation': 'Reproductive Medicine Center, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China.'}, {'ForeName': 'Lv', 'Initials': 'L', 'LastName': 'Jiqiang', 'Affiliation': 'Reproductive Medicine Center, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Huina', 'Affiliation': 'Reproductive Medicine Center, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2016.09.011']
2028,28083927,Program changes are effective and cost-effective in increasing the amount of oil used in preparing corn soy blend porridge for treatment of moderate acute malnutrition in Malawi.,"Corn Soy Blend (CSB) porridge is commonly prepared with oil for treatment of moderate acute malnutrition (MAM). A recent review recommended that 30 g of oil be used with 100 g of CSB to increase energy density and micronutrient absorption. This study assessed the effectiveness and cost-effectiveness of program changes aimed at achieving that target oil:CSB ratio in prepared porridge. Caregivers of children in MAM supplementary feeding programs were assigned to three groups: a control group received monthly rations of 1 L oil, 8 kg CSB in bulk, and social and behavior change communication (SBCC); intervention groups received 2.6 L oil, 8 kg CSB provided either in bulk (Group 1) or four 2-kg packages with printed messages (Group 2), and enhanced SBCC emphasizing the target oil:CSB ratio. Compared to the control, both intervention groups had higher mean added oil per 100 g CSB (18 g, p < 0.01, and 13 g, p= 0.04, higher in groups 1 and 2, respectively), and greater odds of meeting or exceeding the target ratio (28.4, p< 0.01, and 12.7, p= 0.02, in groups 1 and 2, respectively). Cost per caregiver reaching the target ratio was most favorable in Group 1 ($391 in Group 1, $527 in Group 2, and $1,666 in the control). Enhanced SBCC combined with increased oil ration resulted in increased use of oil in CSB porridge in a supplementary feeding program. Modified packaging did not improve effectiveness. However, both interventions were more cost-effective than standard programming.",2017,"Cost per caregiver reaching the target ratio was most favorable in Group 1 ($391 in Group 1, $527 in Group 2, and $1,666 in the control).","['Caregivers of children in MAM supplementary feeding programs', 'moderate acute malnutrition (MAM', 'moderate acute malnutrition in Malawi']","['Corn Soy Blend (CSB', 'control group received monthly rations of 1\xa0L oil, 8\xa0kg CSB in bulk, and social and behavior change communication (SBCC); intervention groups received 2.6\xa0L oil, 8\xa0kg CSB provided either in bulk (Group 1) or four 2-kg packages with printed messages (Group 2), and enhanced SBCC emphasizing the target oil:CSB ratio', 'SBCC combined with increased oil ration']","['Cost per caregiver reaching the target ratio', 'effectiveness', 'energy density and micronutrient absorption', 'effective and cost-effective', 'cost-effective']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}]","[{'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",,0.023737,"Cost per caregiver reaching the target ratio was most favorable in Group 1 ($391 in Group 1, $527 in Group 2, and $1,666 in the control).","[{'ForeName': 'Beatrice Lorge', 'Initials': 'BL', 'LastName': 'Rogers', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Wilner', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'Gray', 'Initials': 'G', 'LastName': 'Maganga', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'Shelley Marcus', 'Initials': 'SM', 'LastName': 'Walton', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'Devika J', 'Initials': 'DJ', 'LastName': 'Suri', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'Breanne K', 'Initials': 'BK', 'LastName': 'Langlois', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'Kenneth Kwan Ho', 'Initials': 'KKH', 'LastName': 'Chui', 'Affiliation': 'Department of Public Health and Community Medicine, School of Medicine, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'Jocelyn M', 'Initials': 'JM', 'LastName': 'Boiteau', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Vosti', 'Affiliation': 'Department of Agricultural and Resource Economics, University of California-Davis, California, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Webb', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12393']
2029,32412952,Trends in Costs of Care and Utilization for Medicaid Patients With Diabetes in Accountable Care Communities.,"BACKGROUND/OBJECTIVES


Medicaid beneficiaries with diabetes have complex care needs. The Accountable Care Communities (ACC) Program is a practice-level intervention implemented by UnitedHealthcare to improve care for Medicaid beneficiaries. We examined changes in costs and utilization for Medicaid beneficiaries with diabetes assigned to ACC versus usual care practices.
RESEARCH DESIGN


Interrupted time series with concurrent control group analysis, at the person-month level. The ACC was implemented in 14 states, and we selected comparison non-ACC practices from those states to control for state-level variation in Medicaid program. We adjusted the models for age, sex, race/ethnicity, comorbidities, seasonality, and state-by-year fixed effects. We examined the difference between ACC and non-ACC practices in changes in the time trends of expenditures and hospital and emergency room utilization, for the 4 largest categories of Medicaid eligibility [Temporary Assistance to Needy Families, Supplemental Security Income (without Medicare), Expansion, Dual-Eligible].
SUBJECTS/MEASURES


Eligibility and claims data from Medicaid adults with diabetes from 14 states between 2010 and 2016, before and after ACC implementation.
RESULTS


Analyses included 1,200,460 person-months from 66,450 Medicaid patients with diabetes. ACC implementation was not associated with significant changes in outcome time trends, relative to comparators, for all Medicaid categories.
CONCLUSIONS


Medicaid patients assigned to ACC practices had no changes in cost or utilization over 3 years of follow-up, compared with patients assigned to non-ACC practices. The ACC program may not reduce costs or utilization for Medicaid patients with diabetes.",2020,"CONCLUSIONS


Medicaid patients assigned to ACC practices had no changes in cost or utilization over 3 years of follow-up, compared with patients assigned to non-ACC practices.","['66,450 Medicaid patients with diabetes', 'Medicaid beneficiaries with diabetes', 'Medicaid adults with diabetes from 14 states between 2010 and 2016, before and after ACC implementation', 'Medicaid patients with diabetes', 'Medicaid Patients With Diabetes in Accountable Care Communities', 'Medicaid beneficiaries with diabetes assigned to ACC versus usual care practices']",[],"['Costs of Care and Utilization', 'cost or utilization', 'costs or utilization', 'costs and utilization']","[{'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]",[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",66450.0,0.0160042,"CONCLUSIONS


Medicaid patients assigned to ACC practices had no changes in cost or utilization over 3 years of follow-up, compared with patients assigned to non-ACC practices.","[{'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Moin', 'Affiliation': 'David Geffen School of Medicine at UCLA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Harwood', 'Affiliation': 'David Geffen School of Medicine at UCLA.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Mangione', 'Affiliation': 'David Geffen School of Medicine at UCLA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Jackson', 'Affiliation': 'David Geffen School of Medicine at UCLA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Ho', 'Affiliation': 'UnitedHealthcare, Minnetonka, MN.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Ettner', 'Affiliation': 'David Geffen School of Medicine at UCLA.'}, {'ForeName': 'O Kenrik', 'Initials': 'OK', 'LastName': 'Duru', 'Affiliation': 'David Geffen School of Medicine at UCLA.'}]",Medical care,['10.1097/MLR.0000000000001318']
2030,28018270,Psychological Effects of a 1-Month Meditation Retreat on Experienced Meditators: The Role of Non-attachment.,"Background:  There are few studies devoted to assessing the impact of meditation-intensive retreats on the well-being, positive psychology, and personality of experienced meditators. We aimed to assess whether a 1-month Vipassana retreat: (a) would increase mindfulness and well-being; (b) would increase prosocial personality traits; and (c) whether psychological changes would be mediated and/or moderated by non-attachment.  Method:  A controlled, non-randomized, pre-post-intervention trial was used. The intervention group was a convenience sample ( n  = 19) of experienced meditators who participated in a 1-month Vipassana meditation retreat. The control group ( n  = 19) comprised matched experienced meditators who did not take part in the retreat. During the retreat, the mean duration of daily practice was 8-9 h, the diet was vegetarian and silence was compulsory. The Experiences Questionnaire (EQ), Non-attachment Scale (NAS), Positive and Negative Affect Schedule (PANAS), Satisfaction With Life Scale (SWLS), Temperament Character Inventory Revised (TCI-R-67), Five Facets Mindfulness Questionnaire (FFMQ), Self-Other Four Immeasurables (SOFI) and the MINDSENS Composite Index were administered. ANCOVAs and linear regression models were used to assess pre-post changes and mediation/moderation effects.  Results:  Compared to controls, retreatants showed increases in non-attachment, observing, MINDSENS, positive-affect, balance-affect, and cooperativeness; and decreases in describing, negative-others, reward-dependence and self-directedness. Non-attachment had a mediating role in decentring, acting aware, non-reactivity, negative-affect, balance-affect and self-directedness; and a moderating role in describing and positive others, with both mediating and moderating effects on satisfaction with life.  Conclusions:  A 1-month Vipassana meditation retreat seems to yield improvements in mindfulness, well-being, and personality, even in experienced meditators. Non-attachment might facilitate psychological improvements of meditation, making it possible to overcome possible ceiling effects ascribed to non-intensive practices.",2016,"Compared to controls, retreatants showed increases in non-attachment, observing, MINDSENS, positive-affect, balance-affect, and cooperativeness; and decreases in describing, negative-others, reward-dependence and self-directedness. Non-attachment had a mediating role in decentring, acting aware, non-reactivity, negative-affect, balance-affect and self-directedness; and a moderating role in describing and positive others, with both mediating and moderating effects on satisfaction with life.  ",['Experienced Meditators'],"['convenience sample ( n  = 19) of experienced meditators who participated in a 1-month Vipassana meditation retreat', '1-Month Meditation Retreat']","['prosocial personality traits', 'non-attachment, observing, MINDSENS, positive-affect, balance-affect, and cooperativeness', 'Experiences Questionnaire (EQ), Non-attachment Scale (NAS), Positive and Negative Affect Schedule (PANAS), Satisfaction With Life Scale (SWLS), Temperament Character Inventory Revised (TCI-R-67), Five Facets Mindfulness Questionnaire (FFMQ), Self-Other Four Immeasurables (SOFI) and the MINDSENS Composite Index', 'mean duration of daily practice']",[],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0150277'}]","[{'cui': 'C0233849', 'cui_str': 'Personality finding'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0222045'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule (assessment scale)'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale (assessment scale)'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",19.0,0.0254023,"Compared to controls, retreatants showed increases in non-attachment, observing, MINDSENS, positive-affect, balance-affect, and cooperativeness; and decreases in describing, negative-others, reward-dependence and self-directedness. Non-attachment had a mediating role in decentring, acting aware, non-reactivity, negative-affect, balance-affect and self-directedness; and a moderating role in describing and positive others, with both mediating and moderating effects on satisfaction with life.  ","[{'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Faculty of Health and Sport Sciences, Primary Care Prevention and Health Promotion Research Network, Zaragoza, Centro de Investigación Biomédica en Red de Salud Mental Zaragoza, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Puebla-Guedea', 'Affiliation': 'Centro de Investigación Biomédica en Red de Salud Mental, Primary Care Prevention and Health Promotion Research Network, Instituto Aragonés de Ciencias de la Salud Zaragoza, Spain.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Herrera-Mercadal', 'Affiliation': 'Centro de Investigación Biomédica en Red de Salud Mental, Primary Care Prevention and Health Promotion Research Network, Instituto Aragonés de Ciencias de la Salud Zaragoza, Spain.'}, {'ForeName': 'Ausias', 'Initials': 'A', 'LastName': 'Cebolla', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, Universitat de ValènciaValencia, Spain; CIBERObn Ciber Physiopathology of Obesity and NutritionSantiago de Compostela, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Soler', 'Affiliation': 'Servei de Psiquiatria, Hospital de la Santa Creu i Sant Pau (Barcelona), Departamento de Psicologia Clínica i de la Salut, Universitat Autònoma de Barcelona, Barcelona, Spain Centro de Investigación Biomédica en Red de Salud Mental, CIBERSAM Madrid, Spain.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Demarzo', 'Affiliation': 'Mente Aberta - Brazilian Center for Mindfulness and Health Promotion, Department of Preventive Medicine, Universidade Federal de Sao PauloSao Paulo, Brazil; Hospital Israelita Albert EinsteinSao Paulo, Brazil.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Vazquez', 'Affiliation': 'Professor of Psychopathology, Universidad Complutense de Madrid, Red PROMOSAM Valencia, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rodríguez-Bornaetxea', 'Affiliation': 'Psychologist and Vipassana Master, President of Baraka Institute San Sebastián, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'García-Campayo', 'Affiliation': 'Miguel Servet Hospital and University of Zaragoza, RedIAPP, Instituto Aragonés de Ciencias de la Salud, Zaragoza, Centro de Investigación Biomédica en Red de Salud Mental Zaragoza, Spain.'}]",Frontiers in psychology,['10.3389/fpsyg.2016.01935']
2031,32119035,Dose-Ranging Effect of Adjunctive Oral Cannabidiol vs Placebo on Convulsive Seizure Frequency in Dravet Syndrome: A Randomized Clinical Trial.,"Importance


Clinical evidence supports effectiveness of cannabidiol for treatment-resistant seizures in Dravet syndrome, but this trial is the first to evaluate the 10-mg/kg/d dose.
Objective


To evaluate the efficacy and safety of a pharmaceutical formulation of cannabidiol, 10 and 20 mg/kg/d, vs placebo for adjunctive treatment of convulsive seizures in patients with Dravet syndrome.
Design, Setting, and Participants


This double-blind, placebo-controlled, randomized clinical trial (GWPCARE2) recruited patients from April 13, 2015, to November 10, 2017, with follow-up completed on April 9, 2018. Of 285 patients screened from 38 centers in the United States, Spain, Poland, the Netherlands, Australia, and Israel, 86 were excluded, and 199 were randomized. Patients were aged 2 to 18 years with a confirmed diagnosis of Dravet syndrome and at least 4 convulsive seizures during the 4-week baseline period while receiving at least 1 antiepileptic drug. Data were analyzed from November 16 (date of unblinding) to December 13 (date of final outputs), 2018, based on intention to treat and per protocol.
Interventions


Patients received cannabidiol oral solution at a dose of 10 or 20 mg/kg per day (CBD10 and CBD20 groups, respectively) or matched placebo in 2 equally divided doses for 14 weeks. All patients, caregivers, investigators, and individuals assessing data were blinded to group assignment.
Main Outcomes and Measures


The primary outcome was change from baseline in convulsive seizure frequency during the treatment period. Secondary outcomes included change in all seizure frequency, proportion with at least a 50% reduction in convulsive seizure activity, and change in Caregiver Global Impression of Change score.
Results


Of 198 eligible patients (mean [SD] age, 9.3 [4.4] years; 104 female [52.5%]), 66 were randomized to the CBD10 group, 67 to the CBD20 group, and 65 to the placebo group, and 190 completed treatment. The percentage reduction from baseline in convulsive seizure frequency was 48.7% for CBD10 group and 45.7% for the CBD20 group vs 26.9% for the placebo group; the percentage reduction from placebo was 29.8% (95% CI, 8.4%-46.2%; P = .01) for CBD10 group and 25.7% (95% CI, 2.9%-43.2%; P = .03) for the CBD20 group. The most common adverse events were decreased appetite, diarrhea, somnolence, pyrexia, and fatigue. Five patients in the CBD20 group discontinued owing to adverse events. Elevated liver transaminase levels occurred more frequently in the CBD20 (n = 13) than the CBD10 (n = 3) group, with all affected patients given concomitant valproate sodium.
Conclusions and Relevance


Adjunctive cannabidiol at doses of 10 and 20 mg/kg/d led to similar clinically relevant reductions in convulsive seizure frequency with a better safety and tolerability profile for the 10-mg/kg/d dose in children with treatment-resistant Dravet syndrome. Dose increases of cannabidiol to greater than 10 mg/kg/d should be tailored to individual efficacy and safety.
Trial Registration


ClinicalTrials.gov Identifier: NCT02224703.",2020,"Elevated liver transaminase levels occurred more frequently in the CBD20 (n = 13) than the CBD10 (n = 3) group, with all affected patients given concomitant valproate sodium.
","['198 eligible patients (mean [SD] age, 9.3 [4.4] years; 104 female [52.5%]), 66 were randomized to the CBD10 group, 67 to the CBD20 group, and 65 to the placebo group, and 190 completed treatment', 'children with treatment-resistant Dravet syndrome', '285 patients screened from 38 centers in the United States, Spain, Poland, the Netherlands, Australia, and Israel, 86 were excluded, and 199 were randomized', 'Patients were aged 2 to 18 years with a confirmed diagnosis of Dravet syndrome and at least 4 convulsive seizures during the 4-week baseline period while receiving at least 1 antiepileptic drug', 'patients with Dravet syndrome', 'Dravet Syndrome', 'patients from April 13, 2015, to November 10, 2017, with follow-up completed on April 9, 2018']","['cannabidiol', 'Adjunctive Oral Cannabidiol vs Placebo', 'placebo', 'CBD20', 'cannabidiol oral solution', 'valproate sodium']","['Elevated liver transaminase levels', 'efficacy and safety', 'appetite, diarrhea, somnolence, pyrexia, and fatigue', 'convulsive seizure frequency', 'change in all seizure frequency, proportion with at least a 50% reduction in convulsive seizure activity, and change in Caregiver Global Impression of Change score', 'safety and tolerability profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517802', 'cui_str': '52.5 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0751122', 'cui_str': 'Myoclonic Epilepsy, Severe, Of Infancy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0751494', 'cui_str': 'Convulsive Seizures'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C0037567', 'cui_str': 'Sodium Valproate'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0751494', 'cui_str': 'Convulsive Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",198.0,0.58063,"Elevated liver transaminase levels occurred more frequently in the CBD20 (n = 13) than the CBD10 (n = 3) group, with all affected patients given concomitant valproate sodium.
","[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Miller', 'Affiliation': ""Department of Neurology, Nicklaus Children's Hospital, Miami, Florida.""}, {'ForeName': 'Ingrid E', 'Initials': 'IE', 'LastName': 'Scheffer', 'Affiliation': ""Epilepsy Research Centre, The University of Melbourne at Austin Health and the Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Gunning', 'Affiliation': 'Stichting Epilepsie Instellingen Nederland, Zwolle, the Netherlands.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Sanchez-Carpintero', 'Affiliation': 'Pediatric Neurology Unit, Clínica Universidad de Navarra, Navarra Institute for Health Research, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gil-Nagel', 'Affiliation': 'Department of Neurology, Hospital Ruber Internacional, Madrid, Spain.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Perry', 'Affiliation': ""Jane and John Justin Neurosciences Center, Cook Children's Medical Center, Ft Worth, Texas.""}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Saneto', 'Affiliation': ""Neuroscience Institute, Division of Pediatric Neurology, Department of Neurology, Seattle Children's Hospital and University of Washington, Seattle.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Checketts', 'Affiliation': 'GW Research, Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Greenwich Biosciences, Inc, Carlsbad, California.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Knappertz', 'Affiliation': 'Greenwich Biosciences, Inc, Carlsbad, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2020.0073']
2032,31580310,Mobilization of the contralateral limb in Slump position: effects on knee extension in healthy adult subjects.,"BACKGROUND AND AIM


In the acute phase of neuropathic pain due to nerve root disorders, the neurodynamic approach proposes the mobilization of the contralateral limb to decrease the pain and increase the range of motion in the affected limb. The aim of this study was to evaluate the effect of the contralateral knee mobilization on the ipsilateral knee extension range of motion in Slump position in healthy adult subjects.
METHODS


Thirty-eight healthy subjects underwent a placebo, control and experimental manoeuvres that included a passive contralateral knee mobilization into extension. The knee, hip and cervical angles and distance between glabella and femoral condyle achieved in Slump test position were measured with an optoelectronic motion analysis system before and after each manoeuvre.
RESULTS


Experimental manoeuvre produced a statistically significant increase of the knee extension ROM when compared to the control (p=.017) and placebo (p=.007) manoeuvres. A significant increase of the hip angle and distance between glabella and femoral condyle was detected after the experimental manoeuvres (p<.001), but not after the placebo and control manoeuvres.
CONCLUSIONS


The contralateral mobilization in Slump position increases the ipsilateral knee extension ROM. Further research is required to confirm that the knee increment ROM was due to the neural component.",2019,"A significant increase of the hip angle and distance between glabella and femoral condyle was detected after the experimental manoeuvres (p<.001), but not after the placebo and control manoeuvres.
","['healthy adult subjects', 'Thirty-eight healthy subjects underwent a']","['contralateral knee mobilization', 'placebo', 'placebo, control and experimental manoeuvres that included a passive contralateral knee mobilization into extension']","['ipsilateral knee extension ROM', 'hip angle and distance between glabella and femoral condyle', 'knee extension ROM', 'knee, hip and cervical angles and distance between glabella and femoral condyle achieved in Slump test position']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0222694', 'cui_str': 'Structure of glabella'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0524414', 'cui_str': 'Condyle'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0430748', 'cui_str': 'Slump test response'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]",38.0,0.0399885,"A significant increase of the hip angle and distance between glabella and femoral condyle was detected after the experimental manoeuvres (p<.001), but not after the placebo and control manoeuvres.
","[{'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Pellicciari', 'Affiliation': 'Department of Neurorehabilitation, IRCCS San Raffaele Pisana, Rome, Italy;. leonardo.pellicciari@gmail.com.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Paci', 'Affiliation': ''}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Geri', 'Affiliation': ''}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Piscitelli', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Baccini', 'Affiliation': ''}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v90i3.7236']
2033,28165552,"Effects of very-low-calorie diet on body composition, metabolic state, and genes expression: a randomized double-blind placebo-controlled trial.","OBJECTIVE


Very low-calorie diets (VLCDs, < 800 kcal day-1) and Ketogenic diet (KD) are generally used as part of integrated intervention, medical monitoring and a program of lifestyle modification, to improve a multitude of clinical states. The effect of three different very low calories KD (VLCKD), with (VLCKD1) or without (VLCKD2,3) synthetic amino acid replacement of the 50% protein intake, were analyzed after weight loss.
PATIENTS AND METHODS


The clinical study used a cross-over randomized double-blind placebo-controlled trial. Obese subjects, who were eligible for the study, were randomly (R) divided into three groups: one intervention group (IG) and two control groups (CG1 and CG2). We comprehensively analyzed body composition, serum metabolites, superoxide dismutase (SOD1), nuclear factor kappa-light-chain-enhancer of activated B cells (NfKB), Chemokine (C-C Motif) Ligand 2 (CCL2) gene expression.
RESULTS


After VLDKDs a significant decreased in BMI was observed. TBF (kg) significantly decrease after VLCKD1 and VLCKD3. After VLCKD2, a reduction of waist circumference (p = 0.02), FM L2-L5 (p < 0.05) was observed. After VLCKD1 reduction of IMAT (p = 0.00), LDL-C (p = 0.00) and HDL-C (p = 0.00) were observed. No significant changes of GH, ESR, and fibrinogen were highlighted. CRP (p = 0.02) reduced significantly after VLCKD3. Significant modulation of SOD1 expression (p = 0.009), CRP and decrease of glucose levels (p = 0.03) were obtained after VLCKD3.
CONCLUSIONS


This is the first study that analyzes comprehensively body composition, metabolic profile, and inflammation and oxidative stress genes expression after VLCKD. Our results show the efficacy of VLCKD with synthetic aminoacidic protein replacement, for the reduction of cardiovascular risk, without the development of sarcopenia and activation of inflammatory and oxidative processes.",2017,"Significant modulation of SOD1 expression (p = 0.009), CRP and decrease of glucose levels (p = 0.03) were obtained after VLCKD3.
",['Obese subjects'],"['placebo', 'very-low-calorie diet', 'intervention group (IG) and two control groups (CG1 and CG2', 'Ketogenic diet (KD', 'low calories KD (VLCKD), with (VLCKD1) or without (VLCKD2,3) synthetic amino acid replacement']","['GH, ESR, and fibrinogen', 'BMI', 'body composition, serum metabolites, superoxide dismutase (SOD1), nuclear factor kappa-light-chain-enhancer of activated B cells (NfKB), Chemokine (C-C Motif', 'SOD1 expression', 'CRP', 'reduction of waist circumference', 'IMAT', 'CRP and decrease of glucose levels', 'LDL-C', 'body composition, metabolic state, and genes expression', 'FM L2-L5']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0021036', 'cui_str': 'Immunoglobulin kappa-Chains'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}]",,0.0679402,"Significant modulation of SOD1 expression (p = 0.009), CRP and decrease of glucose levels (p = 0.03) were obtained after VLCKD3.
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Merra', 'Affiliation': 'Emergency Department, ""A. Gemelli"" General Hospital Foundation, Catholic University of the Sacred Heart, School of Medicine, Rome, Italy. giuseppe.merra@policlinicogemelli.it.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gratteri', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'De Lorenzo', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Barrucco', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Perrone', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Avolio', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bernardini', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marchetti', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Di Renzo', 'Affiliation': ''}]",European review for medical and pharmacological sciences,[]
2034,28194877,Focused breastfeeding counselling improves short- and long-term success in an early-discharge setting: A cluster-randomized study.,"Length of postnatal hospitalization has decreased and has been shown to be associated with infant nutritional problems and increase in readmissions. We aimed to evaluate if guidelines for breastfeeding counselling in an early discharge hospital setting had an effect on maternal breastfeeding self-efficacy, infant readmission and breastfeeding duration. A cluster randomized trial was conducted and assigned nine maternity settings in Denmark to intervention or usual care. Women were eligible if they expected a single infant, intended to breastfeed, were able to read Danish, and expected to be discharged within 50 hr postnatally. Between April 2013 and August 2014, 2,065 mothers were recruited at intervention and 1,476 at reference settings. Results show that the intervention did not affect maternal breastfeeding self-efficacy (primary outcome). However, less infants were readmitted 1 week postnatally in the intervention compared to the reference group (adjusted OR 0.55, 95% CI 0.37, -0.81), and 6 months following birth, more infants were exclusively breastfed in the intervention group (adjusted OR 1.36, 95% CI 1.02, -1.81). Moreover, mothers in the intervention compared to the reference group were breastfeeding more frequently (p < .001), and spend more hours skin to skin with their infants (p < .001). The infants were less often treated for jaundice (p = 0.003) and there was more paternal involvement (p = .037). In an early discharge hospital setting, a focused breastfeeding programme concentrating on increased skin to skin contact, frequent breastfeeding, good positioning of the mother infant dyad, and enhanced involvement of the father improved short-term and long-term breastfeeding success.",2017,"Moreover, mothers in the intervention compared to the reference group were breastfeeding more frequently (p < .001), and spend more hours skin to skin with their infants (p < .001).","['Women were eligible if they expected a single infant, intended to breastfeed, were able to read Danish, and expected to be discharged within 50 hr postnatally', 'nine maternity settings in Denmark to intervention or usual care', 'Between April 2013 and August 2014, 2,065 mothers were recruited at intervention and 1,476 at reference settings']",['breastfeeding counselling'],"['maternal breastfeeding self-efficacy', 'jaundice', 'short- and long-term success', 'maternal breastfeeding self-efficacy, infant readmission and breastfeeding duration']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0586740', 'cui_str': 'Able to read (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0022346', 'cui_str': 'Icterus'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",2065.0,0.105838,"Moreover, mothers in the intervention compared to the reference group were breastfeeding more frequently (p < .001), and spend more hours skin to skin with their infants (p < .001).","[{'ForeName': 'Ingrid M S', 'Initials': 'IMS', 'LastName': 'Nilsson', 'Affiliation': 'The Danish Committee for Health Education, Copenhagen, Denmark.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Strandberg-Larsen', 'Affiliation': 'Department of Public health, Section of Social Medicine, Copenhagen University, Copenhagen, Denmark.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Knight', 'Affiliation': 'Institute of Veterinary Clinical and Animal Sciences, Copenhagen University, Copenhagen, Denmark.'}, {'ForeName': 'Anne Vinkel', 'Initials': 'AV', 'LastName': 'Hansen', 'Affiliation': 'Department of Public health, Section of Social Medicine, Copenhagen University, Copenhagen, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Kronborg', 'Affiliation': 'Department of Public Health, Section of Nursing, Aarhus University, Aarhus, Denmark.'}]",Maternal & child nutrition,['10.1111/mcn.12432']
2035,32413581,Trauma-related cognitions predict treatment response in smokers with PTSD: Evidence from cross-lagged panel analyses.,"OBJECTIVE


Compared to smokers without posttraumatic stress disorders (PTSD), smokers with PTSD smoke more heavily and are less successful in quitting smoking. However, limited research has examined the cognitive pathways underlying this heightened comorbidity. The current study is the first to simultaneously model the cross-sectional and lagged relationships between trauma-related cognitions and cigarette smoking, as well as between trauma-related cognitions and PTSD severity, in smokers with comorbid PTSD receiving treatment.
METHOD


Participants (n = 142) were seeking treatment for smoking cessation and PTSD as part of a randomized controlled trial of varenicline and smoking cessation counseling with or without adjunctive Prolonged Exposure (varenicline + PE vs. varenicline only) (Foa et al., 2017). Data were available for both baseline and end-of-treatment assessments of trauma cognitions severity of cigarette smoking and PTSD symptoms. We conducted both cross-sectional and lagged analysis to simultaneously examine the bidirectional relationship from trauma cognitions and 1) cigarette smoking and 2) PTSD symptoms.
RESULTS


Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only. However, baseline trauma cognitions did not predict post-treatment cigarettes/day. Baseline trauma cognitions (specifically negative beliefs about the self and world) were associated with PTSD severity at both baseline and end of treatment; furthermore, these negative cognitions at baseline positively and prospectively predicted end-of-treatment PTSD severity, but not vice versa. Wald tests revealed that there were no treatment effects on these cross-lagged relationships. Conclusions These findings provide novel empirical support for the importance of addressing trauma-related cognitions in the smoking cessation treatment efforts for patients with comorbid PTSD and cigarette smoking.",2020,"RESULTS


Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only.","['smokers with PTSD', 'patients with comorbid PTSD and cigarette smoking', 'smokers without posttraumatic stress disorders (PTSD), smokers with PTSD smoke', 'Participants (n\u202f=\u202f142) were', 'smokers with comorbid PTSD receiving treatment']","['varenicline and smoking cessation counseling with or without adjunctive Prolonged Exposure (varenicline\u202f+\u202fPE vs. varenicline only', 'varenicline', 'seeking treatment for smoking cessation and PTSD']","['Baseline trauma cognitions', 'baseline trauma cognitions', 'PTSD severity', 'trauma cognitions severity of cigarette smoking and PTSD symptoms']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",142.0,0.00981447,"RESULTS


Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only.","[{'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Mu', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States. Electronic address: wenting.mu@pennmedicine.upenn.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Narine', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Farris', 'Affiliation': 'Department of Psychology, Rutgers University, The State University of New Jersey, United States.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Lieblich', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Yinyin', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'School of Psychological and Cognitive Sciences, Peking University, Beijing, China.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Bredemeier', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106376']
2036,27925426,The impact of home fortification with multiple micronutrient powder on vitamin A status in young children: A multicenter pragmatic controlled trial in Brazil.,"Home fortification with multiple micronutrient powder (MNP) is effective in the prevention of anemia in young children. However, the impact on their vitamin A status remains controversial. This study aimed to evaluate the effect of MNP on vitamin A status in young Brazilian children. A multicenter pragmatic, controlled trial was carried out in primary health centers in four Brazilian cities. In the beginning of the study, the control group (CG) consisted of children 11-14 months old (n = 395) attending in routine pediatric health care. In parallel, the intervention group (IG) was composed of children 6-8 months old (n = 399), in the same health centers, who followed the intervention with MNP for 2-3 months. The analysis of the effect of MNP on vitamin A status was performed by comparing the IG with the CG after a 4- to 6-month follow-up when IG children had reached the age of the controls. The prevalence of vitamin A deficiency (VAD; serum retinol <0.70 μmol/L) in the CG was 16.2%, while in the IG was 7.5%-a 55% reduction in the VAD [prevalence ratio (95% confidence interval) = 0.45 (0.28; 0.72)]. This reduction was also significant when stratifying the study centers by coverage of the Brazilian Vitamin A Supplementation Program. The adjusted mean of vitamin A serum concentrations improved in the IG compared with CG children, with a shift to the right in the vitamin A distribution. Home fortification with MNP was effective in reducing VAD among young Brazilian children.",2017,Home fortification with multiple micronutrient powder (MNP) is effective in the prevention of anemia in young children.,"['primary health centers in four Brazilian cities', 'young children', 'young Brazilian children']","['MNP', 'vitamin', 'home fortification with multiple micronutrient powder', 'multiple micronutrient powder (MNP']","['adjusted mean of vitamin A serum concentrations', 'VAD [prevalence ratio ', 'VAD']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0362282,Home fortification with multiple micronutrient powder (MNP) is effective in the prevention of anemia in young children.,"[{'ForeName': 'Lara Livia Santos', 'Initials': 'LLS', 'LastName': 'Silva', 'Affiliation': 'Department of Nutrition, School of Public Health, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rosângela Aparecida', 'Initials': 'RA', 'LastName': 'Augusto', 'Affiliation': 'Department of Nutrition, School of Public Health, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela Cardoso', 'Initials': 'DC', 'LastName': 'Tietzmann', 'Affiliation': 'Department of Nutrition, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Leopoldina Augusta Souza', 'Initials': 'LAS', 'LastName': 'Sequeira', 'Affiliation': 'Department of Nutrition, Universidade Federal de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Maria Claret Costa Monteiro', 'Initials': 'MCCM', 'LastName': 'Hadler', 'Affiliation': 'School of Nutrition, Federal University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Pascoal Torres', 'Initials': 'PT', 'LastName': 'Muniz', 'Affiliation': 'Department of Health Sciences, Federal University of Acre, Rio Branco, Brazil.'}, {'ForeName': 'Pedro Israel Cabral', 'Initials': 'PIC', 'LastName': 'de Lira', 'Affiliation': 'Department of Nutrition, Universidade Federal de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Marly Augusto', 'Initials': 'MA', 'LastName': 'Cardoso', 'Affiliation': 'Department of Nutrition, School of Public Health, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/mcn.12403']
2037,32413420,Increased risk of cardiac conduction abnormalities with ribociclib in patients with metastatic breast cancer: A combined analysis of phase III randomized controlled trials.,,2020,,['patients with metastatic breast cancer'],['ribociclib'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C4045494', 'cui_str': 'ribociclib'}]",[],,0.0775656,,"[{'ForeName': 'Somedeb', 'Initials': 'S', 'LastName': 'Ball', 'Affiliation': 'Department of Internal Medicine, Texas Tech University Health Sciences Center, Lubbock, TX, USA. Electronic address: somedeb.ball@ttuhsc.edu.'}, {'ForeName': 'Sriman', 'Initials': 'S', 'LastName': 'Swarup', 'Affiliation': 'Division of Hematology & Medical Oncology, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Sultan', 'Affiliation': 'Division of Hematology & Medical Oncology, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}, {'ForeName': 'Kyaw Zin', 'Initials': 'KZ', 'LastName': 'Thein', 'Affiliation': 'Division of Hematology & Medical Oncology, Texas Tech University Health Sciences Center, Lubbock, TX, USA.'}]",Hematology/oncology and stem cell therapy,['10.1016/j.hemonc.2020.03.001']
2038,32413296,Writing to the Mind's Eye of the Blind.,"The implantation of electrodes on the visual cortex of blind individuals could lead to the restoration of a rudimentary form of sight. In this issue of Cell, Beauchamp et al. use electrical stimulation of the visual cortex to create visual perception of shapes.",2020,The implantation of electrodes on the visual cortex of blind individuals could lead to the restoration of a rudimentary form of sight.,[],[],[],[],[],[],,0.0240986,The implantation of electrodes on the visual cortex of blind individuals could lead to the restoration of a rudimentary form of sight.,"[{'ForeName': 'Pieter R', 'Initials': 'PR', 'LastName': 'Roelfsema', 'Affiliation': 'Department of Vision & Cognition, Netherlands Institute for Neuroscience, Meibergdreef 47, 1105 BA Amsterdam, Netherlands; Department of Integrative Neurophysiology, VU University, De Boelelaan 1085, 1081 HV Amsterdam, Netherlands; Department of Psychiatry, Academic Medical Center, Postbus 22660, 1100 DD Amsterdam, Netherlands. Electronic address: p.roelfsema@nin.knaw.nl.'}]",Cell,['10.1016/j.cell.2020.03.014']
2039,31573666,"Safety and Efficacy of Topically Applied Selected Cutibacterium acnes Strains over Five Weeks in Patients with Acne Vulgaris: An Open-label, Pilot Study.","Imbalance in skin microflora, particularly related to certain Cutibacterium acnes strains, may trigger acne. Application of non-acne-causing strains to the skin may modulate the skin microbiome and thereby lead to a reduction in acne. This pilot study evaluates the safety and efficacy of microbiome modulation on acne-prone skin. The study had 2 phases: active induction (5% benzoyl peroxide gel, 7 days) and interventional C. acnes strains treatment (5 weeks). Patients were randomized to either topical skin formulations PT1 (2 strains of C. acnes Single Locus Sequence Typing [SLST] type C3 and K8, 50% each) or PT2 (4 strains of C. acnes SLST type C3 [55%], K8 [5%], A5 [30%] and F4 [10%]). Safety and efficacy was evaluated in 14 patients (PT1=8/14, PT2=6/14). Skin microbiome composition shifted towards study formulations. No untoward adverse events, visible irritation, or significant flare-up were observed. Non-inflamed lesions and skin pH were reduced. Comedone counts improved clinically with no deterioration in inflammatory lesions.",2019,"No untoward adverse events, visible irritation, or significant flare-up were observed.","['Patients with Acne Vulgaris', '14 patients (PT1=8/14, PT2=6/14']","['microbiome modulation', 'topical skin formulations PT1', 'active induction (5% benzoyl peroxide gel, 7 days) and interventional C. acnes strains treatment']","['untoward adverse events, visible irritation', 'Safety and efficacy', 'acne-prone skin', 'Safety and Efficacy', 'skin pH', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}]","[{'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0232445', 'cui_str': 'Skin pH (observable entity)'}]",,0.0177865,"No untoward adverse events, visible irritation, or significant flare-up were observed.","[{'ForeName': 'Ante', 'Initials': 'A', 'LastName': 'Karoglan', 'Affiliation': 'Department of Dermatology, University Hospital Magdeburg, University of Magdeburg, 39120 Magdeburg, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Paetzold', 'Affiliation': ''}, {'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Pereira de Lima', 'Affiliation': ''}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Brüggemann', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tüting', 'Affiliation': ''}, {'ForeName': 'Denny', 'Initials': 'D', 'LastName': 'Schanze', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Güell', 'Affiliation': ''}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Gollnick', 'Affiliation': ''}]",Acta dermato-venereologica,['10.2340/00015555-3323']
2040,32412986,Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised placebo-controlled double-blind study.,"BACKGROUND


After caesarean section, maternal postoperative comfort is critical to allow the new mother to care for her baby. Insufficient pain relief during the postoperative period may delay maternal/infant bonding and, in addition, such pain has been linked to subsequent depression and chronic pain. Caesarean section is commonly performed with a Pfannenstiel incision, and a transversalis fascia plane (TFP) block provides postoperative analgesia in the T12 and L1 dermatomes.
OBJECTIVE


The aim of this study was to investigate the effect of the TFP block on postoperative opioid consumption and pain scores in patients undergoing caesarean section under spinal anaesthesia.
DESIGN


A prospective randomised controlled, double-blind study.
SETTINGS


Single-centre, academic hospital.
PARTICIPANTS


Sixty patients undergoing caesarean section.
INTERVENTIONS


The TFP group (n = 30) received an ultrasound-guided bilateral TFP block with 20 ml of 0.25% bupivacaine. The control group (n = 30) received 20 ml of saline bilaterally. Postoperative analgesia was given every 6 h with intravenous paracetamol 1 g and patient-controlled analgesia (PCA) with morphine.
MAIN OUTCOME MEASURES


Postoperative visual analogue pain scores, morphine consumption, rescue analgesia and opioid-related side effects were evaluated.
RESULTS


In the TFP group, the visual analogue pain scores were significantly lower at rest for 2 h after the operation (P = 0.011) and during active movement at 2, 4 and 8 h postoperatively (P = 0.014, <0.001 and 0.032, respectively). Morphine consumption in the first 24 h after surgery was significantly higher in the control group compared with the TFP group (38.5 ± 11.63 and 19.5 ± 8.33 mg, respectively; P < 0.001). The incidence of postoperative nausea and constipation were statistically higher in the control group than in the TFP group (P < 0.05). Patient satisfaction was significantly higher in the TFP group (P = 0.027).
CONCLUSION


A postoperative TFP block can reduce opioid consumption and relieve acute pain after a caesarean section under spinal anaesthesia.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04172727.",2020,The incidence of postoperative nausea and constipation were statistically higher in the control group than in the TFP group (P < 0.05).,"['Single-centre, academic hospital', 'patients undergoing caesarean section under spinal anaesthesia', 'caesarean section', 'Sixty patients undergoing caesarean section']","['transversalis fascia plane (TFP) block', 'ultrasound-guided bilateral TFP block with 20\u200aml of 0.25% bupivacaine', 'paracetamol 1 g and patient-controlled analgesia (PCA) with morphine', 'TFP', 'Subarachnoid block and ultrasound-guided transversalis fascia plane block', '20\u200aml of saline bilaterally', 'TFP block', 'placebo']","['Patient satisfaction', 'postoperative opioid consumption and pain scores', 'postoperative nausea and constipation', 'visual analogue pain scores', 'Morphine consumption', 'Postoperative visual analogue pain scores, morphine consumption, rescue analgesia and opioid-related side effects', 'acute pain']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0225232', 'cui_str': 'Transversalis fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]",60.0,0.485841,The incidence of postoperative nausea and constipation were statistically higher in the control group than in the TFP group (P < 0.05).,"[{'ForeName': 'Muhammed E', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'From the Department of Anaesthesiology and Reanimation, Ataturk University Faculty of Medicine (MEA, AMY, ECC, IA, EOA, AA), Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine (MEA, AMY, ECC, AA), and Nenehatun State Hospital, Erzurum, Turkey (ZB).'}, {'ForeName': 'Zehra', 'Initials': 'Z', 'LastName': 'Bedir', 'Affiliation': ''}, {'ForeName': 'Ahmet M', 'Initials': 'AM', 'LastName': 'Yayik', 'Affiliation': ''}, {'ForeName': 'Erkan C', 'Initials': 'EC', 'LastName': 'Celik', 'Affiliation': ''}, {'ForeName': 'İrem', 'Initials': 'İ', 'LastName': 'Ates', 'Affiliation': ''}, {'ForeName': 'Elif O', 'Initials': 'EO', 'LastName': 'Ahiskalioglu', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001222']
2041,32413595,Double trouble: Do symptom severity and duration interact to predicting treatment outcomes in adolescent depression?,"Studies suggest that depression severity and duration interact to predict outcomes in depression treatment. To our knowledge, no study has explored this question in a sample with a placebo control, two therapies, and their combination nor with adolescents. We used data from the Treatment of Adolescent Depression Study (N = 439), in which adolescent were randomized to placebo (PBO), cognitive-behavioral therapy (CBT), antidepressants medications (MEDs), or their combination (COMB). We explore the interaction between depression severity, chronicity, and treatments (vs. placebo) in predicting outcomes. There was interaction between severity and chronicity when comparing COMB and CBT with PBO, but not MEDs. In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression. In chronic depression, the effects of CBT did not vary by severity, but the relative effects of COMB grew, being smallest in milder, more dythimic-like depression, and largest in chronic-severe depression. These findings support calls to classify depression by severity and chronicity as well efforts to risk stratify patients to different intensity of care according to these variables.",2020,"In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression.",['Adolescent Depression Study (N\xa0=\xa0439'],"['CBT', 'placebo (PBO), cognitive-behavioral therapy (CBT), antidepressants medications (MEDs), or their combination (COMB', 'placebo']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",[],,0.0183832,"In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression.","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Lorenzo-Luaces', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA. Electronic address: lolorenz@indiana.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rodriguez-Quintana', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Allen J', 'Initials': 'AJ', 'LastName': 'Bailey', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103637']
2042,27883237,Iron concentration in breast milk normalised within one week of a single high-dose infusion of iron isomaltoside in randomised controlled trial.,"AIM


We compared the iron concentration in breast milk after a single high dose of intravenous iron isomaltoside or daily oral iron for postpartum haemorrhage.
METHODS


In this randomised controlled trial, the women were allocated a single dose of intravenous 1200 mg iron isomaltoside or oral iron at a mean daily dose of 70.5 mg. We included 65 women with sufficient breast milk three days after inclusion - 30 from the intravenous iron group and 35 from the oral iron group - and collected breast milk and maternal blood samples three days and one week after allocation.
RESULTS


The mean (±SD) iron concentration in breast milk in the intravenous and oral groups was 0.72 ± 0.27 and 0.40 ± 0.18 mg/L at three days (p < 0.001) and 0.47 ± 0.17 and 0.44 ± 0.25 mg/L after one week (p = 0.64). Baseline samples were not available that soon after birth.
CONCLUSION


A single high dose of intravenous iron isomaltoside for postpartum haemorrhage led to a transient increase in the iron concentration in breast milk three days after treatment compared with oral iron. The difference disappeared one week after treatment, and mean iron concentrations were within the normal range in all samples.",2017,A single high dose of intravenous iron isomaltoside for postpartum haemorrhage led to a transient increase in the iron concentration in breast milk three days after treatment compared with oral iron.,['65 women with sufficient breast milk three days after inclusion - 30 from the intravenous iron group and 35 from the oral iron group - and collected breast milk and maternal blood samples three days and one week after allocation'],"['intravenous iron isomaltoside', 'intravenous iron isomaltoside or daily oral iron', 'intravenous 1200 mg iron isomaltoside or oral iron']","['mean iron concentrations', 'mean (±SD) iron concentration in breast milk']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}]",65.0,0.671015,A single high dose of intravenous iron isomaltoside for postpartum haemorrhage led to a transient increase in the iron concentration in breast milk three days after treatment compared with oral iron.,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Holm', 'Affiliation': 'Department of Obstetrics, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars Lykke', 'Initials': 'LL', 'LastName': 'Thomsen', 'Affiliation': 'Pharmacosmos A/S, Holbaek, Denmark.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Norgaard', 'Affiliation': 'Section for Transfusion Medicine 2034, Capital Region Blood Bank, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Markova', 'Affiliation': 'Department of Obstetrics, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kim F', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Langhoff-Roos', 'Affiliation': 'Department of Obstetrics, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.13681']
2043,27872568,Weekly iron folic acid supplementation plays differential role in maintaining iron markers level in non-anaemic and anaemic primigravida: A randomized controlled study.,"Anaemia during pregnancy is most commonly observed and highly prevalent in South-East Asia. Various effective programmes have been laid down for its management, mainly daily supplementation of iron folic acid (IFA) tablets. Following the same, standard obstetrical practice has included the IFA supplementation without requiring the determination of iron deficiency. In this study, a total of 120 primigravida ( N  = 60; non-anaemic (Hb > 11 g/dl) and  N  = 60 anaemic (Hb = 8-11 g/dl)) were selected among those attending the Antenatal Clinic in Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India. They were supplemented with daily and weekly IFA tablets till 6 weeks postpartum. Corresponding changes in haemoglobin level on advance of pregnancy, side effects and compliance associated with daily and weekly IFA supplementation and its associations with iron status markers were studied. The inflammatory markers were also estimated. The statistical significance level ( p  < 0.05) between the groups were assessed by applying unpaired  t -test using SPSS (version 16.0). The obtained results publicized the salutary role of daily IFA supplementation in improving the haemoglobin level and iron status markers in anaemic pregnant women though the levels could not reach up to the non-anaemic haemoglobin levels. However, weekly IFA supplementation seems to be a better approach in non-anaemic pregnant women where almost comparable results were obtained in terms of haematological parameters, gestation length and birth weight.
CONCLUSION


Weekly IFA supplementation found to be as effective as daily supplementation in iron sufficient non-anaemic pregnant women whereas anaemic pregnant women should be prescribed daily IFA supplementation irrespective of iron replete/deplete state.",2016,The obtained results publicized the salutary role of daily IFA supplementation in improving the haemoglobin level and iron status markers in anaemic pregnant women though the levels could not reach up to the non-anaemic haemoglobin levels.,"['total of 120 primigravida ( N \xa0=\xa060; non-anaemic (Hb\xa0>\xa011\xa0g/dl) and  N \xa0=\xa060 anaemic (Hb\xa0=\xa08-11\xa0g/dl)) were selected among those attending the Antenatal Clinic in Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India', 'non-anaemic and anaemic primigravida', 'non-anaemic pregnant women', 'anaemic pregnant women whereas anaemic pregnant women', 'anaemic pregnant women']","['Weekly iron folic acid supplementation', 'IFA supplementation']","['Anaemia', 'haematological parameters, gestation length and birth weight', 'haemoglobin level on advance of pregnancy, side effects and compliance associated with daily and weekly IFA supplementation', 'haemoglobin level and iron status markers', 'maintaining iron markers level']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0860096', 'cui_str': 'Primigravida (finding)'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplementation (product)'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]",,0.067529,The obtained results publicized the salutary role of daily IFA supplementation in improving the haemoglobin level and iron status markers in anaemic pregnant women though the levels could not reach up to the non-anaemic haemoglobin levels.,"[{'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Shankar', 'Affiliation': 'Department of Biochemistry, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India; Department of Biochemistry, Panjab University, Chandigarh, India.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Division of Reproductive & Child Health, Indian Council of Medical Research, Ansari Nagar, New Delhi 110029, India.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Sandhir', 'Affiliation': 'Department of Biochemistry, Panjab University, Chandigarh, India.'}, {'ForeName': 'Suneeta', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Obstetrics & Gynaecology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Kurra', 'Affiliation': 'Department of Biochemistry, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.'}, {'ForeName': 'Lakhbir', 'Initials': 'L', 'LastName': 'Dhaliwal', 'Affiliation': 'Post Graduate Institute of Medical Education of Research, Chandigarh, India.'}, {'ForeName': 'Gurjit', 'Initials': 'G', 'LastName': 'Kaur', 'Affiliation': 'Genetic Centre, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Nomita', 'Initials': 'N', 'LastName': 'Chandhiok', 'Affiliation': 'Division of Reproductive & Child Health, Indian Council of Medical Research, Ansari Nagar, New Delhi 110029, India.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Dhillon', 'Affiliation': 'Division of Reproductive & Child Health, Indian Council of Medical Research, Ansari Nagar, New Delhi 110029, India.'}, {'ForeName': 'D N', 'Initials': 'DN', 'LastName': 'Rao', 'Affiliation': 'Department of Biochemistry, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.'}]",Saudi journal of biological sciences,[]
2044,32413002,Baseline and Clinical Factors Associated with Response to Amblyopia Treatment in a Randomized Clinical Trial.,"SIGNIFICANCE


We sought to identify baseline and clinical factors that were predictive of the response to amblyopia treatment. We report that binocular amblyopia treatment may be especially effective for moderate amblyopia in orthotropic children.
PURPOSE


We previously reported results from the primary cohort (n = 28) enrolled in a randomized clinical trial (NCT02365090), which found that binocular amblyopia treatment was more effective than patching. Enrollment of an additional 20 children was pre-planned to provide the opportunity to examine factors that may be predictive of response to amblyopia treatment.
METHODS


Forty-eight children (4 to 10 years old) were enrolled, with 24 randomized to contrast-rebalanced binocular game treatment (1 hour a day, 5 days a week) and 24 to patching treatment (2 hours a day, 7 days a week). The primary outcome was change in amblyopic eye best-corrected visual acuity at the 2-week visit. Baseline factors examined were age at enrollment, visual acuity, stereoacuity, and suppression. Clinical factors were etiology, age at diagnosis, prior treatment, and ocular alignment.
RESULTS


At 2 weeks, visual acuity improvement was significantly greater with the binocular game than patching. Children with moderate amblyopia and orthotropia had more visual acuity improvement with binocular game play than did those with severe amblyopia. In addition, children who spent more time playing the binocular game had more improvement. We were not able to confidently identify any baseline or clinical factors that were associated with response to patching treatment.
CONCLUSIONS


Binocular amblyopia treatment was more effective among orthotropic children with moderate amblyopia than among children with microtropia or severe amblyopia.",2020,"At 2 weeks, visual acuity improvement was significantly greater with the binocular game than patching.","['orthotropic children with moderate amblyopia than among children with microtropia or severe amblyopia', 'Children with moderate amblyopia and orthotropia', 'Forty-eight children (4 to 10 years old']","['binocular amblyopia treatment', 'Binocular amblyopia treatment', 'contrast-rebalanced binocular game treatment']","['change in amblyopic eye best-corrected visual acuity', 'visual acuity, stereoacuity, and suppression', 'visual acuity improvement', 'time playing the binocular game']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0271356', 'cui_str': 'Microstrabismus'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}]",48.0,0.177459,"At 2 weeks, visual acuity improvement was significantly greater with the binocular game than patching.","[{'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Birch', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Reed M', 'Initials': 'RM', 'LastName': 'Jost', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Krista R', 'Initials': 'KR', 'LastName': 'Kelly', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Leffler', 'Affiliation': ""Children's Eye Care of North Texas, PA, Plano, Texas.""}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Dao', 'Affiliation': 'ABC Eyes Pediatric Ophthalmology, PA, Dallas, Texas.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Beauchamp', 'Affiliation': 'ABC Eyes Pediatric Ophthalmology, PA, Dallas, Texas.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001514']
2045,30967099,"Effects of the Psychedelic Amphetamine MDA (3,4-Methylenedioxyamphetamine) in Healthy Volunteers.","Entactogens such as 3,4-Methylenedioxymethamphetamine (MDMA, ""molly"", ""ecstasy"") appear to have unusual, potentially therapeutic, emotional effects. Understanding their mechanisms can benefit from clinical experiments with related drugs. Yet the first known drug with such properties, 3,4-Methylenedioxyamphetamine (MDA), remains poorly studied and its pharmacokinetics in humans are unknown. We conducted a within-subjects, double-blind, placebo-controlled study of 1.4 mg/kg oral racemic MDA and compared results to those from our prior similar studies with 1.5 mg/kg oral racemic MDMA. MDA was well-tolerated by participants. MDA induced robust increases in heart rate and blood pressure and increased cortisol and prolactin to a similar degree as MDMA. MDA self-report effects shared features with MDMA as well as with classical psychedelics. MDA self-report effects lasted longer than those of MDMA, with MDA effects remaining elevated at 8 h while MDMA effects resolved by 6 h. Cmax and AUC 0-∞  for MDA were 229 ± 39 (mean ± SD) and 3636 ± 958 µg/L for MDA and 92 ± 61 and 1544 ± 741 µg/L for the metabolite 4-hydroxy-3-methoxyamphetamine (HMA). There was considerable between-subject variation in MDA/HMA ratios. The similarity of MDA and MDMA pharmacokinetics suggests that the greater duration of MDA effects is due to pharmacodynamics rather than pharmacokinetics.",2019,MDA induced robust increases in heart rate and blood pressure and increased cortisol and prolactin to a similar degree as MDMA.,['Healthy Volunteers'],"['Psychedelic Amphetamine MDA (3,4-Methylenedioxyamphetamine', 'placebo', 'oral racemic MDMA', 'oral racemic MDA', 'MDMA', '3,4-Methylenedioxyamphetamine (MDA', 'MDA']",['heart rate and blood pressure and increased cortisol and prolactin'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0018533', 'cui_str': 'Psychedelic Agents'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}]",,0.041886,MDA induced robust increases in heart rate and blood pressure and increased cortisol and prolactin to a similar degree as MDMA.,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Baggott', 'Affiliation': 'a Addiction and Pharmacology Research Laboratory , Friends Research Institute , San Francisco , CA , USA.'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Garrison', 'Affiliation': 'a Addiction and Pharmacology Research Laboratory , Friends Research Institute , San Francisco , CA , USA.'}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Coyle', 'Affiliation': 'a Addiction and Pharmacology Research Laboratory , Friends Research Institute , San Francisco , CA , USA.'}, {'ForeName': 'Gantt P', 'Initials': 'GP', 'LastName': 'Galloway', 'Affiliation': 'a Addiction and Pharmacology Research Laboratory , Friends Research Institute , San Francisco , CA , USA.'}, {'ForeName': 'Allan J', 'Initials': 'AJ', 'LastName': 'Barnes', 'Affiliation': 'b Chemistry and Drug Metabolism, IRP , National Institute on Drug Abuse, NIH , Rockville , MD , USA.'}, {'ForeName': 'Marilyn A', 'Initials': 'MA', 'LastName': 'Huestis', 'Affiliation': 'c Lambert Center for the Study of Medicinal Cannabis and Hemp , Thomas Jefferson University , Philadelphia , PA , USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Mendelson', 'Affiliation': 'a Addiction and Pharmacology Research Laboratory , Friends Research Institute , San Francisco , CA , USA.'}]",Journal of psychoactive drugs,['10.1080/02791072.2019.1593560']
2046,27896921,Effect of iron supplementation during lactation on maternal iron status and oxidative stress: A randomized controlled trial.,"We examined the effect of iron-containing prenatal vitamin-mineral supplements taken postpartum on biomarkers of iron status and oxidative stress. Lactating women (n = 114) were randomly assigned to consume daily one iron-free prenatal vitamin-mineral supplement plus either 27 mg of iron or placebo for approximately 3.5 months. The placebo group took the tablets between meals, while those given iron took the tablets either with (Fe-W) or between meals (Fe-B). Blood and urine samples were collected before and after the supplementation period to analyze hemoglobin (Hb), ferritin, hepcidin, transferrin saturation (TfSat), total plasma iron, and biomarkers of oxidative stress (isoprostane and 8-hydroxy-2-deoxyguanosine (8-OHdG)) and inflammation (C-reactive protein (CRP) and alpha-1-acid glycoprotein (AGP)). There was a trend toward a greater change in Hb among women in the Fe-B group compared to placebo (+2.5 vs. -3.7 g/L, respectively, p = 0.063). When the iron groups were combined, there was a greater change in Hb (+1.4 g/L) compared to placebo (p = 0.010). There were trends toward greater changes in TfSat (p = 0.087) and total plasma iron (p = 0.065) in the iron groups compared to placebo, yet no significant differences between the three groups in change in hepcidin (p = 0.291), isoprostane (p = 0.319), or 8-OHdG (p = 0.659), nor in change in ferritin among those with elevated CRP at baseline (60% of women; p = 0.946); among those without elevated CRP (40% of women), ferritin increased more in the iron groups compared to placebo (p = 0.001). Iron consumption during lactation moderately increased iron status, particularly among women without elevated CRP, and increased Hb, but did not significantly increase oxidative stress.",2017,"Iron consumption during lactation moderately increased iron status, particularly among women without elevated CRP, and increased Hb, but did not significantly increase oxidative stress.",['Lactating women (n\xa0=\xa0114'],"['consume daily one iron-free prenatal vitamin-mineral supplement plus either 27\xa0mg of iron or placebo', 'iron-containing prenatal vitamin-mineral supplements', 'placebo', 'iron supplementation']","['oxidative stress', 'Blood and urine samples', 'hepcidin', 'ferritin', 'hemoglobin (Hb), ferritin, hepcidin, transferrin saturation (TfSat), total plasma iron, and biomarkers of oxidative stress (isoprostane and 8-hydroxy-2-deoxyguanosine (8-OHdG)) and inflammation (C-reactive protein (CRP) and alpha-1-acid glycoprotein (AGP', 'biomarkers of iron status and oxidative stress', 'TfSat', 'maternal iron status and oxidative stress', 'total plasma iron']","[{'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}, {'cui': 'C0556112', 'cui_str': 'Mineral supplementation (product)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0005768'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0858126', 'cui_str': 'Plasma iron'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0949860', 'cui_str': 'Isoprostanes'}, {'cui': 'C0011503', 'cui_str': ""Guanosine, 2'-deoxy-""}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0029297', 'cui_str': 'alpha 1-Acid Glycoprotein'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",114.0,0.303085,"Iron consumption during lactation moderately increased iron status, particularly among women without elevated CRP, and increased Hb, but did not significantly increase oxidative stress.","[{'ForeName': 'Josh M', 'Initials': 'JM', 'LastName': 'Jorgensen', 'Affiliation': 'Department of Nutrition, UC Davis, Davis, California, USA.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Lönnerdal', 'Affiliation': 'Department of Nutrition, UC Davis, Davis, California, USA.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Chantry', 'Affiliation': 'Department of Pediatrics, UC Davis Medical Center, Sacramento, California, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, UC Davis, Davis, California, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12394']
2047,27714970,Regional differences in milk and complementary feeding patterns in infants participating in an international nutritional type 1 diabetes prevention trial.,"Differences in breastfeeding, other milk feeding and complementary feeding patterns were evaluated in infants at increased genetic risk with and without maternal type 1 diabetes (T1D). The Trial to Reduce IDDM in the Genetically at Risk is an international nutritional primary prevention double-blinded randomized trial to test whether weaning to extensively hydrolyzed vs. intact cow's milk protein formula will decrease the development of T1D-associated autoantibodies and T1D. Infant diet was prospectively assessed at two visits and seven telephone interviews between birth and 8 months. Countries were grouped into seven regions: Australia, Canada, Northern Europe, Southern Europe, Central Europe I, Central Europe II and the United States. Newborn infants with a first-degree relative with T1D and increased human leukocyte antigen-conferred susceptibility to T1D were recruited. A lower proportion of infants born to mothers with than without T1D were breastfed until 6 months of age in all regions (range, 51% to 60% vs. 70% to 80%). Complementary feeding patterns differed more by region than by maternal T1D. In Northern Europe, a higher proportion of infants consumed vegetables and fruits daily compared with other regions. Consumption of meat was more frequent in all European regions, whereas cereal consumption was most frequent in Southern Europe, Canada and the United States. Maternal T1D status was associated with breastfeeding and other milk feeding patterns similarly across regions but was unrelated to the introduction of complementary foods. Infant feeding patterns differed significantly among regions and were largely inconsistent with current recommended guidelines.",2017,Maternal T1D status was associated with breastfeeding and other milk feeding patterns similarly across regions but was unrelated to the introduction of complementary foods.,"['infants participating in an international nutritional type 1 diabetes prevention trial', 'Countries were grouped into seven regions: Australia, Canada, Northern Europe, Southern Europe, Central Europe', 'Newborn infants with a first-degree relative with T1D and increased human leukocyte antigen-conferred susceptibility to T1D were recruited']",[],"['Maternal T1D status', 'cereal consumption']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0028413', 'cui_str': 'Northern Europe'}, {'cui': 'C0037724', 'cui_str': 'Southern Europe'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0019721', 'cui_str': 'HL-A Antigens'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0007757', 'cui_str': 'Cereal Grain'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0512169,Maternal T1D status was associated with breastfeeding and other milk feeding patterns similarly across regions but was unrelated to the introduction of complementary foods.,"[{'ForeName': 'Anita M', 'Initials': 'AM', 'LastName': 'Nucci', 'Affiliation': 'Department of Nutrition, Georgia State University, Atlanta, Georgia, USA.'}, {'ForeName': 'Suvi M', 'Initials': 'SM', 'LastName': 'Virtanen', 'Affiliation': 'Nutrition Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Susa', 'Initials': 'S', 'LastName': 'Sorkio', 'Affiliation': 'Nutrition Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Bärlund', 'Affiliation': 'Nutrition Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cuthbertson', 'Affiliation': 'Pediatrics Epidemiology Center, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Uusitalo', 'Affiliation': 'Pediatrics Epidemiology Center, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Lawson', 'Affiliation': ""Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada.""}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Salonen', 'Affiliation': ""Children's Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.""}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Berseth', 'Affiliation': 'Mead Johnson Nutrition, Evansville, Indiana, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ormisson', 'Affiliation': 'Department of Paediatrics, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Eveliina', 'Initials': 'E', 'LastName': 'Lehtonen', 'Affiliation': 'Nutrition Unit, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Savilahti', 'Affiliation': ""Children's Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.""}, {'ForeName': 'Dorothy J', 'Initials': 'DJ', 'LastName': 'Becker', 'Affiliation': ""Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dupré', 'Affiliation': 'Robarts Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': 'Pediatrics Epidemiology Center, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knip', 'Affiliation': ""Children's Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.""}, {'ForeName': 'Hans K', 'Initials': 'HK', 'LastName': 'Åkerblom', 'Affiliation': ""Children's Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/mcn.12354']
2048,31859593,Association of cognitive biases with human papillomavirus vaccine hesitancy: a cross-sectional study.,"Given the link between vaccine hesitancy and vaccine-preventable disease outbreaks, it is critical to examine the cognitive processes that contribute to the development of vaccine hesitancy, especially among parents of adolescents. We conducted a secondary analysis of baseline data from a two-phase randomized trial on human papillomavirus to investigate how vaccine hesitancy and intent to vaccinate are associated with six decision-making factors: base rate neglect, conjunction fallacy, sunk cost bias, present bias, risk aversion, and information avoidance. We recruited 1,413 adults residing in the United States with at least one daughter aged 9-17 years old through an online survey on Amazon Mechanical Turk. Vaccine hesitancy, intent to vaccinate, and susceptibility to cognitive biases was measured through a series of brief questionnaires. 1,400 participants were in the final analyzed sample. Most participants were white (74.1%), female (71.6%), married (75.3%), and had a college or graduate/professional education (88.8%). Conjunction fallacy, sunk cost bias, information avoidance, and present bias may be associated with vaccine hesitancy. Intent to vaccinate may be associated with information avoidance. These results suggest that cognitive biases play a role in developing parental vaccine hesitancy and vaccine-related behavior.",2020,"Vaccine hesitancy, intent to vaccinate, and susceptibility to cognitive biases was measured through a series of brief questionnaires.","['1,413 adults residing in the United States with at least one daughter aged 9-17\xa0years old through an online survey on Amazon Mechanical Turk', 'Most participants were white (74.1%), female (71.6%), married (75.3%), and had a college or graduate/professional education (88.8', 'parents of adolescents', '1,400 participants were in the final analyzed sample']",['human papillomavirus vaccine hesitancy'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0337911', 'cui_str': 'Turks (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0013647', 'cui_str': 'Education, Professional'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine (finding)'}]",[],1400.0,0.0582943,"Vaccine hesitancy, intent to vaccinate, and susceptibility to cognitive biases was measured through a series of brief questionnaires.","[{'ForeName': 'Tiffany D', 'Initials': 'TD', 'LastName': 'Pomares', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Buttenheim', 'Affiliation': 'Department of Family and Community Health, University of Pennsylvania School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Avnika B', 'Initials': 'AB', 'LastName': 'Amin', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Joyce', 'Affiliation': 'Department of Family and Community Health, University of Pennsylvania School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Rachael M', 'Initials': 'RM', 'LastName': 'Porter', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Bednarczyk', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Yale School of Medicine, Yale Institute for Global Health, New Haven, CT, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1698243']
2049,32413933,Adalimumab for maintenance of remission in Crohn's disease.,"BACKGROUND


Conventional medications for Crohn's disease (CD) include anti-inflammatory drugs, immunosuppressants and corticosteroids. If an individual does not respond, or loses response to first-line treatments, then biologic therapies such as tumour necrosis factor-alpha (TNF-α) antagonists such as adalimumab are considered for treating CD. Maintenance of remission of CD is a clinically important goal, as disease relapse can negatively affect quality of life.
OBJECTIVES


To assess the efficacy and safety of adalimumab for maintenance of remission in people with quiescent CD.
SEARCH METHODS


We searched the Cochrane IBD Group Specialized Register, CENTRAL, MEDLINE, Embase, and clinicaltrials.gov from inception to April 2019.
SELECTION CRITERIA


We considered for inclusion randomized controlled trials (RCTs) comparing adalimumab to placebo or to an active comparator.
DATA COLLECTION AND ANALYSIS


We analyzed data on an intention-to-treat basis. We calculated risk ratios (RRs) and corresponding 95% confidence intervals (95% CI) for dichotomous outcomes. The primary outcome was failure to maintain clinical remission. We define clinical remission as a Crohn's Disease Activity Index (CDAI) score of < 150. Secondary outcomes were failure to maintain clinical response, endoscopic remission, endoscopic response, histological remission and adverse events (AEs). We assessed biases using the Cochrane 'Risk of bias' tool. We used GRADE to assess the overall certainty of evidence supporting the primary outcome.
MAIN RESULTS


We included six RCTs (1158 participants). We rated four trials at low risk of bias and two trials at unclear risk of bias. All participants had moderate-to-severe CD that was in clinical remission. Four studies were placebo-controlled (1012 participants). Two studies (70 participants) compared adalimumab to active medication (azathioprine, mesalamine or 6-mercaptopurine) in participants who had an ileocolic resection prior to study enrolment. Adalimumab versus placebo Fifty-nine per cent (252/430) of participants treated with adalimumab failed to maintain clinical remission at 52 to 56 weeks, compared with 86% (217/253) of participants receiving placebo (RR 0.70, 95% CI 0.64 to 0.77; 3 studies, 683 participants; high-certainty evidence). Among those who received prior TNF-α antagonist therapy, 69% (129/186) of adalimumab participants failed to maintain clinical or endoscopic response at 52 to 56 weeks, compared with 93% (108/116) of participants who received placebo (RR 0.76, 95% CI 0.68 to 0.85; 2 studies, 302 participants; moderate-certainty evidence). Fifty-one per cent (192/374) of participants who received adalimumab failed to maintain clinical remission at 24 to 26 weeks, compared with 79% (149/188) of those who received placebo (RR 0.66, 95% CI 0.52 to 0.83; 2 studies, 554 participants; moderate-certainty evidence). Eighty-seven per cent (561/643) of participants who received adalimumab reported an AE compared with 85% (315/369) of participants who received placebo (RR 1.01, 95% CI 0.94 to 1.09; 4 studies, 1012 participants; high-certainty evidence). Serious adverse events were seen in 8% (52/643) of participants who received adalimumab and 14% (53/369) of participants who received placebo (RR 0.56, 95% CI 0.39 to 0.80; 4 studies, 1012 participants; moderate-certainty evidence) and withdrawal due to AEs was reported in 7% (45/643) of adalimumab participants compared to 13% (48/369) of placebo participants (RR 0.59, 95% CI 0.38 to 0.91; 4 studies, 1012 participants; moderate-certainty evidence). Commonly-reported AEs included CD aggravation, arthralgia, nasopharyngitis, urinary tract infections, headache, nausea, fatigue and abdominal pain. Adalimumab versus active comparators No studies reported failure to maintain clinical remission. One study reported on failure to maintain clinical response and endoscopic remission at 104 weeks in ileocolic resection participants who received either adalimumab, azathioprine or mesalamine as post-surgical maintenance therapy. Thirteen per cent (2/16) of adalimumab participants failed to maintain clinical response compared with 54% (19/35) of azathioprine or mesalamine participants (RR 0.23, 95% CI 0.06 to 0.87; 51 participants). Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence). One study reported on failure to maintain endoscopic response at 24 weeks in ileocolic resection participants who received either adalimumab or 6-mercaptopurine (6-MP) as post-surgical maintenance therapy. Nine per cent (1/11) of adalimumab participants failed to maintain endoscopic remission compared with 50% (4/8) of 6-MP participants (RR 0.18, 95% CI 0.02 to 1.33; 19 participants).
AUTHORS' CONCLUSIONS


Adalimumab is an effective therapy for maintenance of clinical remission in people with quiescent CD. Adalimumab is also effective in those who have previously been treated with TNF-α antagonists. The effect of adalimumab in the post-surgical setting is uncertain. More research is needed in people with recent bowel surgery for CD to better determine treatment plans following surgery. Future research should continue to explore factors that influence initial and subsequent biologic selection for people with moderate-to-severe CD. Studies comparing adalimumab to other active medications are needed, to help determine the optimal maintenance therapy for CD.",2020,"Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence).","['people with moderate-to-severe CD', ""Crohn's disease"", 'people with quiescent CD', 'participants who had an ileocolic resection prior to study enrolment']","['adalimumab to placebo', 'azathioprine', 'adalimumab', '6-MP', 'adalimumab or 6-mercaptopurine (6-MP', 'TNF-α antagonist therapy', 'adalimumab, azathioprine or mesalamine', 'azathioprine or mesalamine', 'mesalamine', 'Adalimumab', 'Adalimumab versus active comparators', 'adalimumab to active medication (azathioprine, mesalamine or 6-mercaptopurine', 'placebo']","['maintain clinical response', 'maintain clinical or endoscopic response', 'maintain endoscopic remission', ""Crohn's Disease Activity Index (CDAI) score"", 'efficacy and safety', 'maintain clinical remission', 'moderate-certainty evidence) and withdrawal due to AEs', 'failure to maintain clinical response, endoscopic remission, endoscopic response, histological remission and adverse events (AEs', 'CD aggravation, arthralgia, nasopharyngitis, urinary tract infections, headache, nausea, fatigue and abdominal pain', 'failure to maintain clinical remission', 'calculated risk ratios (RRs', 'Serious adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C1280902', 'cui_str': 'Ileocolic resection'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",,0.562927,"Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence).","[{'ForeName': 'Cassandra M', 'Initials': 'CM', 'LastName': 'Townsend', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Tran M', 'Initials': 'TM', 'LastName': 'Nguyen', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cepek', 'Affiliation': 'Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Abbass', 'Affiliation': 'Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Parker', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'MacDonald', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jairath', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012877.pub2']
2050,32414137,Alcohol Hangover Does Not Alter the Application of Model-Based and Model-Free Learning Strategies.,"Frequent alcohol binges shift behavior from goal-directed to habitual processing modes. This shift in reward-associated learning strategies plays a key role in the development and maintenance of alcohol use disorders and seems to persist during (early stages of) sobriety in at-risk drinkers. Yet still, it has remained unclear whether this phenomenon might be associated with alcohol hangover and thus also be found in social drinkers. In an experimental crossover design,  n  = 25 healthy young male participants performed a two-step decision-making task once sober and once hungover (i.e., when reaching sobriety after consuming 2.6 g of alcohol per estimated liter of total body water). This task allows the separation of effortful model-based and computationally less demanding model-free learning strategies. The experimental induction of alcohol hangover was successful, but we found no significant hangover effects on model-based and model-free learning scores, the balance between model-free and model-based valuation (ω), or perseveration tendencies (π). Bayesian analyses provided positive evidence for the null hypothesis for all measures except π (anecdotal evidence for the null hypothesis). Taken together, alcohol hangover, which results from a single binge drinking episode, does not impair the application of effortful and computationally costly model-based learning strategies and/or increase model-free learning strategies. This supports the notion that the behavioral deficits observed in at-risk drinkers are most likely not caused by the immediate aftereffects of individual binge drinking events.",2020,Bayesian analyses provided positive evidence for the null hypothesis for all measures except π (anecdotal evidence for the null hypothesis).,['n  = 25 healthy young male participants'],[],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],[],25.0,0.00984522,Bayesian analyses provided positive evidence for the null hypothesis for all measures except π (anecdotal evidence for the null hypothesis).,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berghäuser', 'Affiliation': 'Chair of Addiction Research, Institute for Clinical Psychology and Psychotherapy, Faculty of Psychology TU Dresden, Chemnitzer Str. 46, 01062 Dresden, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Bensmann', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Zink', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Endrass', 'Affiliation': 'Chair of Addiction Research, Institute for Clinical Psychology and Psychotherapy, Faculty of Psychology TU Dresden, Chemnitzer Str. 46, 01062 Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beste', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}, {'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Stock', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Fetscherstr. 74, 01307 Dresden, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9051453']
2051,32414066,Benefits of Adhering to a Mediterranean Diet Supplemented with Extra Virgin Olive Oil and Pistachios in Pregnancy on the Health of Offspring at 2 Years of Age. Results of the San Carlos Gestational Diabetes Mellitus Prevention Study.,"The intrauterine environment may be related to the future development of chronic diseases in the offspring. The St. Carlos gestational diabetes mellitus (GDM) prevention study, is a randomized controlled trial that evaluated the influence of the early (before 12th gestational week) Mediterranean diet (MedDiet) on the onset of GDM and adverse gestational outcomes. Out of 874 women assessed after delivery (440 control group (CG)/434 intervention group (IG)), 703 children were followed (365/338; CG/IG), with the aim to assess whether the adherence to a MedDiet during pregnancy induces health benefits for the offspring during the first two years of life. Logistic regression analysis showed that the IG in children of mothers with pre-gestational body mass index (BMI) < 25 kg/m 2  and normal glucose tolerance (NGT), was associated with a lower risk (RR(95% CI)) of suffering from severe events requiring hospitalization due to bronchiolitis/asthma (0.75(0.58-0.98) and 0.77(0.59-0.99), respectively) or other diseases that required either antibiotic (0.80(0.65-0.98) and 0.80(0.65-0.99), respectively), corticosteroid treatment (0.73(0.59-0.90) and 0.79(0.62-1.00) respectively) or both (all  p  < 0.05). A nutritional intervention based on the MedDiet during pregnancy is associated with a reduction in offspring's hospital admissions, especially in women with pre-gestational BMI < 25 kg/m 2  and NGT.",2020,"A nutritional intervention based on the MedDiet during pregnancy is associated with a reduction in offspring's hospital admissions, especially in women with pre-gestational BMI < 25 kg/m 2  and NGT.","['women with pre-gestational BMI < 25 kg/m 2  and NGT', '874 women assessed after delivery (440 control group (CG)/434 intervention group (IG)), 703 children']","['Mediterranean Diet Supplemented with Extra Virgin Olive Oil and Pistachios', 'Mediterranean diet (MedDiet']",['normal glucose tolerance (NGT'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0459819', 'cui_str': 'Pistachio nut'}]","[{'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",874.0,0.0489339,"A nutritional intervention based on the MedDiet during pregnancy is associated with a reduction in offspring's hospital admissions, especially in women with pre-gestational BMI < 25 kg/m 2  and NGT.","[{'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Melero', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Assaf-Balut', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Nuria García de la', 'Initials': 'NG', 'LastName': 'Torre', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Jiménez', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bordiú', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Laura Del', 'Initials': 'LD', 'LastName': 'Valle', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Valerio', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Familiar', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Durán', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Runkle', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'María Paz de', 'Initials': 'MP', 'LastName': 'Miguel', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Montañez', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Barabash', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'Cuesta', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Herraiz', 'Affiliation': 'Facultad de Medicina. Medicina II Department, Universidad Complutense de Madrid, 28040, Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Izquierdo', 'Affiliation': 'Facultad de Medicina. Medicina II Department, Universidad Complutense de Madrid, 28040, Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Rubio', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Alfonso L', 'Initials': 'AL', 'LastName': 'Calle-Pascual', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9051454']
2052,31375879,A phase I study of the PARP inhibitor niraparib in combination with bevacizumab in platinum-sensitive epithelial ovarian cancer: NSGO AVANOVA1/ENGOT-OV24.,"BACKGROUND


Combining poly(ADP-ribose) polymerase (PARP) inhibitors with antiangiogenic agents appeared to enhance activity vs PARP inhibitors alone in a randomized phase II trial.
MATERIALS AND METHODS


In AVANOVA (NCT02354131) part 1, patients with measurable/evaluable high-grade serous/endometrioid platinum-sensitive ovarian cancer received bevacizumab 15 mg/kg every 21 days with escalating doses of niraparib capsules (100, 200, or 300 mg daily) in a 3 + 3 dose-escalation design. Primary objectives were to evaluate safety and tolerability and to determine the recommended phase II dose (RP2D).
RESULTS


Three of 12 enrolled patients had germline BRCA2 mutations. In cycle 1, nine patients experienced grade 3 toxicities: five with hypertension, three with anemia, and one with thrombocytopenia. There was one dose-limiting toxicity (grade 4 thrombocytopenia with niraparib 300 mg), thus the RP2D was bevacizumab 15 mg/kg with niraparib 300 mg. The response rate was 50%; disease was stabilized in a further 42%. Median progression-free survival was 11.6 (95% confidence interval 8.4-20.1) months. Niraparib pharmacokinetics were consistent with historical single-agent data. Overlapping exposure was observed across the dose ranges tested on days 1 and 21.
CONCLUSIONS


There was one dose-limiting toxicity; other adverse events were typical PARP inhibitor and antiangiogenic class effects. Niraparib-bevacizumab showed promising activity; Part 2 (vs bevacizumab) was recently reported and phase III comparison with standard-of-care therapy is planned.",2019,Median progression-free survival was 11.6 (95% confidence interval 8.4-20.1) months.,"['patients with measurable/evaluable high-grade serous/endometrioid platinum-sensitive ovarian cancer received', 'platinum-sensitive epithelial ovarian cancer', '12 enrolled patients had germline BRCA2 mutations']","['bevacizumab', 'Niraparib-bevacizumab', 'bevacizumab 15\xa0mg/kg every 21\xa0days with escalating doses of niraparib capsules', 'PARP inhibitor niraparib in combination with bevacizumab']","['Median progression-free survival', 'response rate', 'grade 3 toxicities', 'safety and tolerability and to determine the recommended phase II dose (RP2D']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C2744440', 'cui_str': 'niraparib'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C3873150', 'cui_str': 'Every twenty one days (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C1882413', 'cui_str': 'PARP Inhibitors'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",12.0,0.0443735,Median progression-free survival was 11.6 (95% confidence interval 8.4-20.1) months.,"[{'ForeName': 'Mansoor Raza', 'Initials': 'MR', 'LastName': 'Mirza', 'Affiliation': 'Nordic Society of Gynecological Oncology (NSGO), Copenhagen, Denmark. mansoor@rh.regionh.dk.'}, {'ForeName': 'Troels K', 'Initials': 'TK', 'LastName': 'Bergmann', 'Affiliation': 'Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Mau-Sørensen', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, 5073, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'René dePont', 'Initials': 'RD', 'LastName': 'Christensen', 'Affiliation': 'Nordic Society of Gynecological Oncology (NSGO), Copenhagen, Denmark.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Åvall-Lundqvist', 'Affiliation': 'Nordic Society of Gynecological Oncology (NSGO), Copenhagen, Denmark.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Birrer', 'Affiliation': 'Comprehensive Cancer Center, The University of Alabama, Birmingham, USA.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Jørgensen', 'Affiliation': 'Nordic Society of Gynecological Oncology (NSGO), Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Roed', 'Affiliation': 'Nordic Society of Gynecological Oncology (NSGO), Copenhagen, Denmark.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Malander', 'Affiliation': 'Nordic Society of Gynecological Oncology (NSGO), Copenhagen, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Nielsen', 'Affiliation': 'Clinical Pharmacology and Pharmacy, Department of Public Health, Environmental Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Lassen', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, 5073, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Brøsen', 'Affiliation': 'Clinical Pharmacology and Pharmacy, Department of Public Health, Environmental Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Bjørge', 'Affiliation': 'Nordic Society of Gynecological Oncology (NSGO), Copenhagen, Denmark.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Mäenpää', 'Affiliation': 'Nordic Society of Gynecological Oncology (NSGO), Copenhagen, Denmark.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03917-z']
2053,32414411,Steps to recovery: body weight-supported treadmill training for critically ill patients: a randomized controlled trial.,"BACKGROUND


Early mobilization has been proven effective for patients in intensive care units (ICUs) to improve functional recovery. However, early mobilization of critically ill, often mechanically ventilated, patients is cumbersome because of the attachment to tubes, drains, monitoring devices and muscle weakness. A mobile treadmill with bodyweight support may help to initiate mobilization earlier and more effectively. The aim of this study is to assess the effectiveness of weight-supported treadmill training in critically ill patients during and after ICU stay on time to independent functional ambulation.
METHODS


In this randomized controlled trial, a custom-built bedside body weight-supported treadmill will be used and evaluated. Patients are included if they have been mechanically ventilated for at least 48 hours, are able to follow instructions, have quadriceps muscle strength of Medical Research Council sum-score 2 (MRC 2) or higher, can sit unsupported and meet the safety criteria for physical exercise. Exclusion criteria are language barriers, no prior walking ability, contraindications for physiotherapy or a neurological condition as reason for ICU admission. We aim to include 88 patients and randomize them into either the intervention or the control group. The intervention group will receive usual care plus bodyweight-supported treadmill training (BWSTT) daily. The BWSSTT consists of walking on a mobile treadmill while supported by a harness. The control group will receive usual care physiotherapy treatment daily consisting of progressive activities such as bed-cycling and active functional training exercises. In both groups, we will aim for a total of 40 minutes of physiotherapy treatment time every day in one or two sessions, as tolerated by the patient. The primary outcome is time to functional ambulation as measured in days, secondary outcomes include walking distance, muscle strength, status of functional mobility and symptoms of post-traumatic stress. All measurements will be done by assessors who are blinded to the intervention on the regular wards until hospital discharge.
DISCUSSION


This will be the first study comparing the effects of BWSTT and conventional physiotherapy for critically ill patients during and after ICU stay. The results of this study contribute to a better understanding of the effectiveness of early physiotherapy interventions for critically ill patients.
TRIAL REGISTRATION


Dutch Trial Register (NTR) ID: NL6766. Registered at 1 December 2017.",2020,This will be the first study comparing the effects of BWSTT and conventional physiotherapy for critically ill patients during and after ICU stay.,"['patients in intensive care units (ICUs', 'critically ill patients during and after ICU stay', '88 patients and randomize them into either the intervention or the control group', 'critically ill patients', 'critically ill patients during and after ICU stay on time to independent functional ambulation', 'Patients are included if they have been mechanically ventilated for at least 48\u2009hours, are able to follow instructions, have quadriceps muscle strength of Medical Research Council sum-score 2 (MRC 2) or higher, can sit unsupported and meet the safety criteria for physical exercise']","['conventional physiotherapy', 'usual care plus bodyweight-supported treadmill training (BWSTT) daily', 'usual care physiotherapy treatment daily consisting of progressive activities such as bed-cycling and active functional training exercises', 'weight-supported treadmill training']","['time to functional ambulation as measured in days, secondary outcomes include walking distance, muscle strength, status of functional mobility and symptoms of post-traumatic stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0578715', 'cui_str': 'Does sit unsupported'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.130516,This will be the first study comparing the effects of BWSTT and conventional physiotherapy for critically ill patients during and after ICU stay.,"[{'ForeName': 'Robin C H', 'Initials': 'RCH', 'LastName': 'Kwakman', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Juultje', 'Initials': 'J', 'LastName': 'Sommers', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Horn', 'Affiliation': 'Department of Intensive Care, Neurosciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Nollet', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Raoul H H', 'Initials': 'RHH', 'LastName': 'Engelbert', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Marike', 'Initials': 'M', 'LastName': 'van der Schaaf', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands. m.vanderschaaf@amsterdamumc.nl.'}]",Trials,['10.1186/s13063-020-04333-y']
2054,27686370,Nutritional status and complementary feeding among HIV-exposed infants: a prospective cohort study.,"Complementary feeding is crucial for improving child survival and promoting growth and development, particularly among HIV-exposed children who have higher risk of morbidity and mortality than their un-exposed peers. This prospective study employed an infant and child feeding index (ICFI) to measure complementary feeding and determine its association with nutritional status among 2092 HIV-exposed infants followed from 6 to 24 months of age in Dar es Salaam, Tanzania. The ICFI measured both quality and quantity of complementary feeding, including current breastfeeding status, food consistency, dietary diversity scores (DDS), food group frequency score, and meal frequency. The ICFI score ranged from 0 to 9; the median score was 6 (Inter-Quartile Range, IQR= 4-7). After adjusting for potential confounders, high ICFI scores were associated with reduced risk of stunting (high vs. low tertile hazard ratio, HR: 0.72; 95% confidence interval, CI: 0.57, 0.91; P< 0.01) and underweight (high vs. low tertile HR: 0.79; 95% CI: 0.61, 1.02; P= 0.07). Low DDS were associated with higher risk of stunting (low vs. high tertile HR: 1.59; 95% CI: 1.23, 2.07; P< 0.01) and underweight (low vs. high tertile HR: 1.48; 95% CI: 1.12, 1.96; P= 0.01). In this setting, high DDS and ICFI scores were protective of stunting and underweight. We recommend for nutrition programs in low-income countries to emphasize educating HIV-exposed children's caregivers on the importance of dietary diversity and optimal complementary feeding to improve nutritional status in this important subpopulation.",2017,"Low DDS were associated with higher risk of stunting (low vs. high tertile HR: 1.59; 95% CI: 1.23, 2.07; P< 0.01) and underweight (low vs. high tertile HR: 1.48; 95% CI: 1.12, 1.96; P= 0.01).","['HIV-exposed infants', '2092 HIV-exposed infants followed from 6 to 24 months of age in Dar es Salaam, Tanzania']",[],"['ICFI score', 'quality and quantity of complementary feeding, including current breastfeeding status, food consistency, dietary diversity scores (DDS), food group frequency score, and meal frequency', 'risk of stunting', 'higher risk of stunting']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]",2092.0,0.032501,"Low DDS were associated with higher risk of stunting (low vs. high tertile HR: 1.59; 95% CI: 1.23, 2.07; P< 0.01) and underweight (low vs. high tertile HR: 1.48; 95% CI: 1.12, 1.96; P= 0.01).","[{'ForeName': 'Pili', 'Initials': 'P', 'LastName': 'Kamenju', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Enju', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Hertzmark', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Rodrick', 'Initials': 'R', 'LastName': 'Kisenge', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Kupka', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Karim P', 'Initials': 'KP', 'LastName': 'Manji', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Duggan', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Wafaie W', 'Initials': 'WW', 'LastName': 'Fawzi', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12358']
2055,32414381,Results of caring and reaching for health (CARE): a cluster-randomized controlled trial assessing a worksite wellness intervention for child care staff.,"BACKGROUND


Child care workers are among the lowest paid US workers and experience a wide array of health concerns. The physical and mental demands of their job and the lack of employer-provided health-insurance increase health risks. The Caring and Reaching for Health (CARE) study evaluated a 6-month Healthy Lifestyles intervention targeting child care workers' physical activity (primary outcome), other health behaviors, and their workplace health environment.
METHODS


Eligible child care centers, defined as being in operation for at least 2 years and employing at least four staff, were enrolled into CARE's cluster-randomized trial. Centers and their child care staff were randomly assigned to either the Healthy Lifestyles (HL) intervention arm or the Healthy Finances (HF) attention control arm using a block randomization approach. Intervention components were delivered through in-person workshops, center-level displays, informational magazines, director coaching, electronic messaging, and an interactive website. Outcome measures were collected during center visits at baseline and immediately post-intervention by trained data collectors blinded to center arm assignment. Workers' physical activity was assessed with accelerometers, worn for 7 days. Secondary outcome measures included biometric assessments of health and fitness, web-based surveys about health behaviors, and an environmental audit of workplace supports for health. Multi-level linear mixed models assessed worker- and center-level changes in these outcomes.
RESULTS


Participants included 553 child care workers representing 56 centers (HL = 250 staff/28 centers, HF = 303 staff/28 centers). At 6 months, moderate-to-vigorous physical activity declined slightly in both arms (- 1.3 min/day, 95% CI: - 3.0, 0.3 in HL; - 1.9 min/day, 95% CI: - 3.3, - 0.5 in HF), but there was no significant group by time interaction. Several secondary outcomes for other health behaviors and workplace health environment showed improvements in favor of the intervention arm, yet differences did not remain statistically significant after adjustment for multiple comparisons.
CONCLUSIONS


While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment, results confirmed the pressing need to focus on the health of child care workers. Future interventions should focus on prevalent health issues (e.g., weight, stress), include both high-tech and high-touch intervention strategies, and address work conditions or other social determinants of health (e.g. wages) as a means of improving the health of these essential workers.
TRIAL REGISTRATION


Care2BWell: Worksite Wellness for Child Care (NCT02381938).",2020,"CONCLUSIONS


While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment","['Centers and their child care staff', ""Eligible child care centers, defined as being in operation for at least 2 years and employing at least four staff, were enrolled into CARE's cluster-randomized trial"", 'child care staff', 'Participants included 553 child care workers representing 56 centers (HL\u2009=\u2009250 staff/28 centers, HF\u2009=\u2009303 staff/28 centers']","[""Healthy Lifestyles intervention targeting child care workers' physical activity (primary outcome), other health behaviors, and their workplace health environment"", 'Healthy Lifestyles (HL) intervention arm or the Healthy Finances (HF) attention control arm using a block randomization approach', 'worksite wellness intervention']","['biometric assessments of health and fitness, web-based surveys about health behaviors, and an environmental audit of workplace supports for health', ""Workers' physical activity"", 'moderate-to-vigorous physical activity', 'health behaviors']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0376243', 'cui_str': 'finances'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.0874431,"CONCLUSIONS


While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Linnan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB 7440, Chapel Hill, North Carolina, 27599-7440, USA. linnan@email.unc.edu.'}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Falon T', 'Initials': 'FT', 'LastName': 'Smith', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Westgate', 'Affiliation': 'Department of Biostatistics, College of Public Heath, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Hales', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Arandia', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB 7440, Chapel Hill, North Carolina, 27599-7440, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Neshteruk', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00968-x']
2056,32414338,Ultrasound in managing extrapulmonary tuberculosis: a randomized controlled two-center study.,"BACKGROUND


Patients with clinically suspected tuberculosis are often treated empirically, as diagnosis - especially of extrapulmonary tuberculosis - remains challenging. This leads to an overtreatment of tuberculosis and to underdiagnosis of possible differential diagnoses.
METHODS


This open-label, parallel-group, superiority randomized controlled trial is done in a rural and an urban center in Tanzania. HIV-positive and -negative adults (≥18 years) with clinically suspected extrapulmonary tuberculosis are randomized in a 1:1 ratio to an intervention- or control group, stratified by center and HIV status. The intervention consists of a management algorithm including extended focused assessment of sonography for HIV and tuberculosis (eFASH) in combination with chest X-ray and microbiological tests. Treatment with anti-tuberculosis drugs is started, if eFASH is positive, chest X-ray suggests tuberculosis, or a microbiological result is positive for tuberculosis. Patients in the control group are managed according national guidelines. Treatment is started if microbiology is positive or empirically according to the treating physician. The primary outcome is the proportion of correctly managed patients at 6 months (i.e patients who were treated with anti-tuberculosis treatment and had definite or probable tuberculosis, and patients who were not treated with anti-tuberculosis treatment and did not have tuberculosis). Secondary outcomes are the proportion of symptom-free patients at two and 6 months, and time to death. The sample size is 650 patients.
DISCUSSION


This study will determine, whether ultrasound in combination with other tests can increase the proportion of correctly managed patients with clinically suspected extrapulmonary tuberculosis, thus reducing overtreatment with anti-tuberculosis drugs.
TRIAL REGISTRATION


PACTR, Registration number: PACTR201712002829221, registered December 1st 2017.",2020,"This study will determine, whether ultrasound in combination with other tests can increase the proportion of correctly managed patients with clinically suspected extrapulmonary tuberculosis, thus reducing overtreatment with anti-tuberculosis drugs.
","['correctly managed patients with clinically suspected extrapulmonary tuberculosis', 'rural and an urban center in Tanzania', 'managing extrapulmonary tuberculosis', 'patients who were treated with anti-tuberculosis treatment and had definite or probable tuberculosis, and patients who were not treated with anti-tuberculosis treatment and did not have tuberculosis', 'Patients with clinically suspected tuberculosis', '650 patients', 'HIV-positive and -negative adults (≥18\u2009years) with clinically suspected extrapulmonary tuberculosis']","['management algorithm including extended focused assessment of sonography for HIV and tuberculosis (eFASH) in combination with chest X-ray and microbiological tests', 'intervention- or control']","['proportion of symptom-free patients at two and 6\xa0months, and time to death']","[{'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0679362', 'cui_str': 'Tuberculosis, extrapulmonary'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0436342', 'cui_str': 'Free of symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.184641,"This study will determine, whether ultrasound in combination with other tests can increase the proportion of correctly managed patients with clinically suspected extrapulmonary tuberculosis, thus reducing overtreatment with anti-tuberculosis drugs.
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ndege', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania. rndege@ihi.or.tz.'}, {'ForeName': 'Omary', 'Initials': 'O', 'LastName': 'Ngome', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Farida', 'Initials': 'F', 'LastName': 'Bani', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Yvan', 'Initials': 'Y', 'LastName': 'Temba', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Herieth', 'Initials': 'H', 'LastName': 'Wilson', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Vanobberghen', 'Affiliation': 'Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Hella', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Winfrid', 'Initials': 'W', 'LastName': 'Gingo', 'Affiliation': 'St Francis Referral Hospital, Ifakara, United Republic of Tanzania.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sasamalo', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Dorcas', 'Initials': 'D', 'LastName': 'Mnzava', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Namvua', 'Initials': 'N', 'LastName': 'Kimera', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hiza', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wigayi', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Herry', 'Initials': 'H', 'LastName': 'Mapesi', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Irene B', 'Initials': 'IB', 'LastName': 'Kato', 'Affiliation': 'Mwananyamala Regional Referral Hospital, Dar es salaam, United Republic of Tanzania.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Mhimbira', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Reither', 'Affiliation': 'Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Battegay', 'Affiliation': 'Faculty of Medicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Paris', 'Affiliation': 'Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Weisser', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rohacek', 'Affiliation': 'Ifakara Health Institute, Ifakara, United Republic of Tanzania, Off Mlabani Passage, P. O Box 53, Ifakara, Tanzania. mrohacek@ihi.or.tz.'}]",BMC infectious diseases,['10.1186/s12879-020-05073-9']
2057,32414406,Sustained effects of faculty leadership development modules for clinical instructors of core competences education in Taiwan: a four-year explanatory case study.,"BACKGROUND


The Accreditation Council for Graduate Medical Education (ACGME) core competencies (CC) in general medicine-based primary care are essential for junior medical trainees. In this country, a regular faculty development (FD) program aimed at training faculty in instructing (teaching and assessing) these CC had operated. However, leadership was not emphasized. In a new intervention module, the roles and associated responsibilities of clinical instructors to conduct, design, and lead CC-based education were emphasis.
AIMS


This follow-up explanatory case study compares the effectiveness of intervention module with that of the previous regular module.
METHODS


The regular group (n = 28) comprised clinical instructors who participated in the FD module during the 2013-2014 year while the intervention group (n = 28) was composed of 2015-2016 participants. Prior to the formal (hands-on) training, participants in the intervention group were asked to study the online materials of the regular module. These participants then received a 30-h hands-on training in conducting, designing, and leading skills. Finally, they prepared a 10-h reflective end-of-module presentation of their real-world practices.
RESULTS


Following the training, a higher degree improvement in participants self-reported familiarity with CC education, self-confidence in their ability to deliver CC education and sustained involve CC education were noted among the intervention FD group, compared with the regular FD group. In the intervention group, senior academicians (associate and full professor) are more substantially involved in designing and leading CC-based courses than junior academicians (lecturers and assistant professors). Among non-teaching award winners of in the intervention FD group, the follow-up degree of sustained involvement in delivering, designing and leading CC-based courses was significantly higher than that of the regular group.
CONCLUSIONS


Our study demonstrated that leadership training in the intervention FD modules substantially motivated clinical instructors to become leaders in CC education.",2020,"Following the training, a higher degree improvement in participants self-reported familiarity with CC education, self-confidence in their ability to deliver CC education and sustained involve","['clinical instructors of core competences education in Taiwan', 'The regular group (n\u2009=\u200928) comprised clinical instructors who participated in the FD module during the 2013-2014\u2009year while the intervention group (n\u2009=\u200928) was composed of 2015-2016 participants']","['leadership training', 'faculty leadership development modules', 'regular faculty development (FD) program aimed at training faculty in instructing (teaching and assessing']",['CC education'],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",,0.0174185,"Following the training, a higher degree improvement in participants self-reported familiarity with CC education, self-confidence in their ability to deliver CC education and sustained involve","[{'ForeName': 'Fa-Yauh', 'Initials': 'FY', 'LastName': 'Lee', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan. yangyy@vghtpe.gov.tw.'}, {'ForeName': 'Chia-Chang', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ling-Ju', 'Initials': 'LJ', 'LastName': 'Huang', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ching-Chih', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jen-Feng', 'Initials': 'JF', 'LastName': 'Liang', 'Affiliation': 'Faculty of medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shiau-Shian', 'Initials': 'SS', 'LastName': 'Huang', 'Affiliation': 'Faculty of medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Shin', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Dai-Yin', 'Initials': 'DY', 'LastName': 'Lu', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chiao-Lin', 'Initials': 'CL', 'LastName': 'Chuang', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ling-Yu', 'Initials': 'LY', 'LastName': 'Yang', 'Affiliation': 'Faculty of medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Division of General Medicine, Taipei Veteran General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Shulruf', 'Affiliation': 'New South Wales Sydney University, Sydney, Australia.'}, {'ForeName': 'Chen-Huan', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Faculty of medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shou-Yen', 'Initials': 'SY', 'LastName': 'Kao', 'Affiliation': 'Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}]",BMC medical education,['10.1186/s12909-020-02065-w']
2058,27574336,Finding Meaning in Written Emotional Expression by Family Caregivers of Persons With Dementia.,"This study tested the effect of written emotional expression on the ability to find meaning in caregiving and the effects of finding meaning on emotional state and psychological burden in 91 dementia family caregivers. In a pretest-posttest design, participants were randomly assigned to either an experimental or a comparison group. Experimental caregivers (n = 57) wrote about their deepest thoughts and feelings about caring for a family member with dementia, whereas those in the comparison group (n = 34) wrote about nonemotional topics. Results showed enhanced meaning-making abilities in experimental participants relative to comparison participants, particularly for those who used more positive emotion words. Improved meaning-making ability was in turn associated with psychological benefits at posttest, but experimental participants did not show significantly more benefit than comparison participants. We explore the mediating roles of the meaning-making process as well as some of the background characteristics of the individual caregivers and their caregiving environments.",2016,"Results showed enhanced meaning-making abilities in experimental participants relative to comparison participants, particularly for those who used more positive emotion words.","['91 dementia family caregivers', 'Family Caregivers of Persons With Dementia']",['written emotional expression'],['enhanced meaning-making abilities'],"[{'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}]",91.0,0.0270694,"Results showed enhanced meaning-making abilities in experimental participants relative to comparison participants, particularly for those who used more positive emotion words.","[{'ForeName': 'Howard K', 'Initials': 'HK', 'LastName': 'Butcher', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, USA howard-butcher@uiowa.edu.'}, {'ForeName': 'Jean K', 'Initials': 'JK', 'LastName': 'Gordon', 'Affiliation': 'Communication Sciences & Disorders, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Ji Woon', 'Initials': 'JW', 'LastName': 'Ko', 'Affiliation': 'Department of Nursing Science, Sun Moon University, Asan, Chungcheongnam-do, South Korea.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Perkhounkova', 'Affiliation': 'Office for Nursing Research and Scholarship, The University of Iowa College of Nursing, Iowa City, IA, USA.'}, {'ForeName': 'Jun Young', 'Initials': 'JY', 'LastName': 'Cho', 'Affiliation': 'Communication Sciences & Disorders, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rinner', 'Affiliation': 'Information Technology Services, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lutgendorf', 'Affiliation': 'Department of Psychology, University of Iowa, Iowa City, IA, USA.'}]",American journal of Alzheimer's disease and other dementias,[]
2059,32414185,"ZeOxaNMulti Trial: A Randomized, Double-Blinded, Placebo-Controlled Trial of Oral PMA-zeolite to prevent Chemotherapy-Induced Side Effects, in particular, Peripheral Neuropathy.","Chemotherapy-induced peripheral neuropathy (CIPN) is the most frequently reported adverse effect of oxaliplatin. In this study, we set out to evaluate the role of the panaceo-micro-activation (PMA) zeolite in the reduction of the incidence of CIPN and hematological and liver toxicity. The possible impact of the PMA-zeolite as an adjuvant therapeutic agent is based on its detoxification properties toward agents promoting the development of neuropathy (e.g., ammonium - recognized as a neurotoxic agent produced by tumors), as well as its positive impact on immunity and oxidative stress through its effects in the gastrointestinal tract. From April 2015 to October 2018, a total of 120 patients (pts) diagnosed with predominantly colorectal cancer requiring oxaliplatin-based chemotherapy were randomized to receive either the PMA-zeolite (Multizeo Med) or placebo while undergoing oxaliplatin-based chemotherapy. A nerve-conduction study (NCS)&nbsp;was planned at the baseline, after three and six months of chemotherapy, to evaluate CIPN. Furthermore, the evaluation of hematological and liver toxicity was performed during every cycle of chemotherapy. 70.6% and 64.3% of patients developed CIPN in the placebo and the PMA-zeolite group, respectively. Patients treated with the PMA-zeolite were able to undergo more cycles of chemotherapy (p = 0.03), which also indicates a significant improvement in tolerance to the therapy. The group treated with the PMA-zeolite showed a lower CIPN (although not statistically significant within the whole group of subjects) compared to patients receiving placebo. This advantage was, however, statistically significant in men (p = 0.047). In addition, supplementation with the PMA-zeolite resulted in a lower incidence of severe-grade hematological toxicity (trend toward statistical significance of p = 0.09 was observed). Cancer patients may benefit from the therapy with the appropriate certified zeolite-products (e.g., the PMA-zeolite) for human use in CIPN. The lower CIPN (statistically significant results in the male subgroup) was accompanied by a trend of lower incidence of severe-grade hematological toxicity. Furthermore, these benefits led to a better tolerance toward chemotherapy (increase in cycles) and allow an improved compliance with the oncological treatment protocol.",2020,"Patients treated with the PMA-zeolite were able to undergo more cycles of chemotherapy (p = 0.03), which also indicates a significant improvement in tolerance to the therapy.","['From April 2015 to October 2018, a total of 120 patients (pts) diagnosed with predominantly colorectal cancer requiring', 'Cancer patients']","['PMA-zeolite (Multizeo Med) or placebo while undergoing oxaliplatin-based chemotherapy', 'oxaliplatin', 'Placebo', 'oxaliplatin-based chemotherapy', 'placebo']","['severe-grade hematological toxicity', 'lower CIPN', 'tolerance', 'CIPN', 'hematological and liver toxicity', 'CIPN and hematological and liver toxicity']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0078755', 'cui_str': 'Zeolite'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}]",120.0,0.052801,"Patients treated with the PMA-zeolite were able to undergo more cycles of chemotherapy (p = 0.03), which also indicates a significant improvement in tolerance to the therapy.","[{'ForeName': 'Maria Giuseppa', 'Initials': 'MG', 'LastName': 'Vitale', 'Affiliation': 'Medical Oncology Unit, University Hospital of Modena, 41125 Modena, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Barbato', 'Affiliation': 'Medical Oncology Unit, AORN Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Crispo', 'Affiliation': 'Epidemiology and Biostatistics Unit, Istituto Nazionale Tumori-IRCCS ""Fondazione G. Pascale"", 80131 Naples, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Habetswallner', 'Affiliation': 'UOC Neurofisiopatologia AORN Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Bernardo Maria De', 'Initials': 'BM', 'LastName': 'Martino', 'Affiliation': 'UOC Neurofisiopatologia AORN Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Riccardi', 'Affiliation': 'Medical Oncology Unit, AORN Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Maione', 'Affiliation': 'Medical Oncology Unit, AORN Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Eisenwagen', 'Affiliation': 'Panaceo International GmbH, 9585 Goedersdorf, Austria.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Vitale', 'Affiliation': 'School of Medicine and Surgery, University of Campania Luigi Vanvitelli, 81100 Caserta, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Cartenì', 'Affiliation': 'Medical Oncology Unit, AORN Antonio Cardarelli, 80131 Naples, Italy.'}]","Molecules (Basel, Switzerland)",['10.3390/molecules25102297']
2060,32414331,"Patient information, communication and competence empowerment in oncology (PIKKO) - evaluation of a supportive care intervention for overall oncological patients. Study protocol of a non-randomized controlled trial.","BACKGROUND


Cancer patients have to undergo a difficult medical therapy and are also confronted with various psychological, social and economic problems. Support is available from many providers, but patients often gain no access to it. Accordingly, there is a need for a single point of contact that can provide advice, information and assistance. In the state of Saarland, Germany, a supportive new consulting and information path (PIKKO) for all types of cancer is currently evaluated by the German Cancer Society, the Cancer Society of the Saarland, three statutory health insurances and the Jena University Hospital. PIKKO is designed to improve quality of life, self-efficacy, health literacy and patient satisfaction and to reduce psychological distress, related health care costs and the days of inability to work. This methodical work presents the process and analysis planning of this evaluation.
METHODS


The study population includes all cancer types, both new and existing diseases. PIKKO (with patient navigator, oncological knowledge database, specialized oncological counseling) is evaluated within a controlled, non-randomized, comparative, multicenter, longitudinal design. In addition to patient surveys, data from statutory health insurances and utilization data from the web database are collected, and interviews with patient navigators and doctors are carried out. Patients are assigned to a control (usual care) or an intervention group (u. c. + PIKKO). Primary outcome is the health related quality of life (SF-12) six months after baseline. Secondary outcomes are self-efficacy (GSE), psychological distress such as depression (PHQ-9) or anxiety (GAD-7), health literacy (HLS-EU-Q47) and patient satisfaction in health care (Qualiskope-A). Furthermore, the time course of direct costs of medical care (e.g. work disability days) and usage data of the intervention modules are analyzed. Among other statistical procedures, we use t-tests, univariate tests and growth curve models.
DISCUSSION


If PIKKO proves to be effective, recommendations can be made to health organizations, which should lead to the concept being rolled out throughout Germany and included into oncological guidelines. We expect PIKKO to be a useful addition to usual cancer care, helping to improve the quality of life of cancer patients and reduce healthcare costs.
TRIAL REGISTRATION


This study was retrospectively registered in the German Clinical Trial Register under DRKS00016703 (21.02.2019, the reason for the delay was the prioritization of the study management in the first year to establish the new approach into practice). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00016703.",2020,"PIKKO is designed to improve quality of life, self-efficacy, health literacy and patient satisfaction and to reduce psychological distress, related health care costs and the days of inability to work.","['Cancer patients', 'overall oncological patients']",['supportive care intervention'],"['quality of life, self-efficacy, health literacy and patient satisfaction', 'health related quality of life (SF-12', 'self-efficacy (GSE), psychological distress such as depression (PHQ-9) or anxiety (GAD-7), health literacy (HLS-EU-Q47) and patient satisfaction in health care (Qualiskope-A']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]","[{'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",,0.0946291,"PIKKO is designed to improve quality of life, self-efficacy, health literacy and patient satisfaction and to reduce psychological distress, related health care costs and the days of inability to work.","[{'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Schneider', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany. nico.schneider@med.uni-jena.de.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bäcker', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Brenk-Franz', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Keinki', 'Affiliation': 'German Cancer Society, Kuno-Fischer-Strasse 8, 14057, Berlin, Germany.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Hübner', 'Affiliation': 'Department of Hematology and Medical Oncology, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Brandt', 'Affiliation': 'IKK Südwest, Berliner Promenade 1, 66111, Saarbrücken, Germany.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'von der Winkel', 'Affiliation': 'IKK Südwest, Berliner Promenade 1, 66111, Saarbrücken, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Hager', 'Affiliation': 'ze:roPraxen, Bodelschwinghstrasse 10/3, 68723, Schwetzingen, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Strauss', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Altmann', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Stoystrasse 3, 07740, Jena, Germany.'}]",BMC medical research methodology,['10.1186/s12874-020-01002-1']
2061,32414347,"The PAPHIO study protocol: a randomised controlled trial with a 2 x 2 crossover design of physical activity adherence, psychological health and immunological outcomes in breast cancer survivors.","BACKGROUND


The PAPHIO study; a randomized controlled trial with 2X2 crossover design will implement a self-directed physical activity program in which participants will engage in self-monitoring and receive motivational interviewing to enhance physical activity adherence. The study aims to determine the effects of 24 weeks self-directed activity combined with motivational interviewing (MI) on (i) psychological health, (ii) quality of life (QoL) and (iii) immune function in female breast cancer survivors.
METHODS


The study will recruit 64 female breast cancer survivors within 3 years of diagnosis and at least 6 months post primary treatments at Western Health Sunshine Hospital, Melbourne, Australia. They will be randomly allocated to immediate intervention (IIG group) or delayed intervention groups (DIG group) in a 1:1 ratio. All participants will be given a wearable device (Fitbit Alta HR) and undertake self-directed physical activity for 24 weeks and will receive MI for 12 weeks (IIG; during week 0 to week 12 and DIG; during week 13 to week 24). Participants' daily step count and the changes of immune cell functionality will be assessed at the beginning (week 1: T1), week 12 (T2) and week 24 (T3) of the program. Physical activity adherence will be assessed at T2 and T3. Participants will also complete four questionnaires assessing exercise self-regulation (BREQ2), exercise barrier and task self-efficacy, mental health (DASS-21) and QoL (FACT-B) at three time points (T1 to T3). Linear-mixed models will be used to assess the relationship between physical activity volume by step counting and mental health (DASS-21), QoL (FACT-B), immune biomarkers, self-regulation (BREQ2) and self-efficacy at T1, T2 and T3;between 2 groups.
DISCUSSION


We expect this physical activity intervention to be acceptable and beneficial to the participants in terms of psychological and immunological well-being with the potential outcomes to be implemented more widely at relatively low cost to these or other patient populations.
TRIAL REGISTRATION


Australian New Zealand Clinical trials Registry- ACTRN12619001271190. Prospectively registered on 13 September 2019.",2020,"We expect this physical activity intervention to be acceptable and beneficial to the participants in terms of psychological and immunological well-being with the potential outcomes to be implemented more widely at relatively low cost to these or other patient populations.
","['Prospectively registered on 13 September 2019', 'breast cancer survivors', 'female breast cancer survivors', '64 female breast cancer survivors within 3\xa0years of diagnosis and at least 6\xa0months post primary treatments at Western Health Sunshine Hospital, Melbourne, Australia']","['physical activity intervention', 'immediate intervention (IIG group) or delayed intervention', 'physical activity adherence, psychological health', 'Registry', 'motivational interviewing', '24\u2009weeks self-directed activity combined with motivational interviewing (MI', 'self-directed physical activity program']","['Physical activity adherence', 'physical activity volume by step counting and mental health (DASS-21), QoL (FACT-B), immune biomarkers, self-regulation (BREQ2) and self-efficacy', 'i) psychological health, (ii) quality of life (QoL) and (iii) immune function', 'questionnaires assessing exercise self-regulation (BREQ2), exercise barrier and task self-efficacy, mental health (DASS-21) and QoL (FACT-B', 'immune cell functionality', 'physical activity adherence']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",,0.0682482,"We expect this physical activity intervention to be acceptable and beneficial to the participants in terms of psychological and immunological well-being with the potential outcomes to be implemented more widely at relatively low cost to these or other patient populations.
","[{'ForeName': 'Supa', 'Initials': 'S', 'LastName': 'Pudkasam', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia. supa.pudkasam@live.vu.edu.au.'}, {'ForeName': 'Meron', 'Initials': 'M', 'LastName': 'Pitcher', 'Affiliation': 'Breast Cancer Service, Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Breast Cancer Service, Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""O'Connor"", 'Affiliation': 'IPC Health Altona Meadows, Melbourne, VIC, Australia.'}, {'ForeName': 'Nanthaphan', 'Initials': 'N', 'LastName': 'Chinlumprasert', 'Affiliation': 'Bernadette de Lourdes School of Nursing Science, Assumption University, Bangkok, Thailand.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Stojanovska', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Polman', 'Affiliation': 'School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Brisbane, Qld, Australia.'}, {'ForeName': 'Vasso', 'Initials': 'V', 'LastName': 'Apostolopoulos', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, VIC, Australia. vasso.apostolopoulos@vu.edu.au.'}]",BMC public health,['10.1186/s12889-020-08827-x']
2062,32414368,Preparing for an orthopedic consultation using an eHealth tool: a randomized controlled trial in patients with hip and knee osteoarthritis.,"BACKGROUND


To evaluate the effect of a stand-alone mobile and web-based educational intervention (eHealth tool) compared to usual preparation of a first orthopedic consultation of patients with hip or knee osteoarthritis (OA) on patients' satisfaction.
METHODS


A two-armed randomized controlled trial involving 286 patients with (suspicion of) hip or knee OA, randomly allocated to either receiving an educational eHealth tool to prepare their upcoming consultation (n = 144) or usual care (n = 142). Satisfaction with the consultation on three subscales (range 1-4) of the Consumer Quality Index (CQI - primary outcome) and knowledge (assessed using 22 statements on OA, range 0-22), treatment beliefs (assessed by the Treatment beliefs in OsteoArthritis questionnaire, range 1-5), assessment of patient's involvement in consultation by the surgeon (assessed on a 5-point Likert scale) and patient satisfaction with the outcome of the consultation (numeric rating scale), were assessed.
RESULTS


No differences between groups were observed on the 3 subscales of the CQI (group difference (95% CI): communication 0.009 (- 0.10, 0.12), conduct - 0.02 (- 0.12, 0.07) and information provision 0.02 (- 0.18, 0.21)). Between group differences (95% CI) were in favor of the intervention group for knowledge (1.4 (0.6, 2.2)), negative beliefs regarding physical activities (- 0.19 (- 0.37, - 0.002) and pain medication (- 0.30 (- 0.49, - 0.01)). We found no differences on other secondary outcomes.
CONCLUSIONS


An educational eHealth tool to prepare a first orthopedic consultation for hip or knee OA does not result in higher patient satisfaction with the consultation, but it does influence cognitions about osteoarthritis.
TRIAL REGISTRATION


Dutch Trial Register (trial number NTR6262). Registered 30 January 2017.",2020,"An educational eHealth tool to prepare a first orthopedic consultation for hip or knee OA does not result in higher patient satisfaction with the consultation, but it does influence cognitions about osteoarthritis.
","['patients with hip and knee osteoarthritis', '286 patients with (suspicion of) hip or knee OA', ""patients with hip or knee osteoarthritis (OA) on patients' satisfaction""]","['educational eHealth tool to prepare their upcoming consultation (n\u2009=\u2009144) or usual care', 'stand-alone mobile and web-based educational intervention (eHealth tool']","[""Consumer Quality Index (CQI - primary outcome) and knowledge (assessed using 22 statements on OA, range 0-22), treatment beliefs (assessed by the Treatment beliefs in OsteoArthritis questionnaire, range 1-5), assessment of patient's involvement in consultation by the surgeon (assessed on a 5-point Likert scale) and patient satisfaction with the outcome of the consultation (numeric rating scale"", 'pain medication', 'negative beliefs regarding physical activities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030699', 'cui_str': 'Client participation'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",286.0,0.118311,"An educational eHealth tool to prepare a first orthopedic consultation for hip or knee OA does not result in higher patient satisfaction with the consultation, but it does influence cognitions about osteoarthritis.
","[{'ForeName': 'Aniek A O M', 'Initials': 'AAOM', 'LastName': 'Claassen', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, PO Box 9011, Nijmegen, GM, 6500, The Netherlands. a.claassen@maartenskliniek.nl.'}, {'ForeName': 'Henk J', 'Initials': 'HJ', 'LastName': 'Schers', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Vincent J J F', 'Initials': 'VJJF', 'LastName': 'Busch', 'Affiliation': 'Department of Orthopaedic Surgery, Sint Maartenskliniek, Nijmegen, The Netherlands.'}, {'ForeName': 'Petra J C', 'Initials': 'PJC', 'LastName': 'Heesterbeek', 'Affiliation': 'Sint Maartenskliniek Research, Sint Maartenskliniek, Nijmegen, The Netherlands.'}, {'ForeName': 'Frank H J', 'Initials': 'FHJ', 'LastName': 'van den Hoogen', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, PO Box 9011, Nijmegen, GM, 6500, The Netherlands.'}, {'ForeName': 'Thea P M', 'Initials': 'TPM', 'LastName': 'Vliet Vlieland', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Cornelia H M', 'Initials': 'CHM', 'LastName': 'van den Ende', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, PO Box 9011, Nijmegen, GM, 6500, The Netherlands.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-01130-0']
2063,32414398,Individuals living in an onchocerciasis focus and treated three-monthly with ivermectin develop fewer new onchocercal nodules than individuals treated annually.,"BACKGROUND


Little information is available on the effect of ivermectin on the third- and fourth-stage larvae of Onchocerca volvulus. To assess a possible prophylactic effect of ivermectin on this parasite, we compared the effects of different ivermectin regimens on the acquisition of onchocercal nodules.
METHODS


We analyzed data from a controlled randomized clinical trial of ivermectin conducted in the Mbam Valley (Cameroon) between 1994 and 1998 in a cohort of onchocerciasis infected individuals. The number of nodules that appeared between the start and the end of the clinical trial was analyzed, using ANOVA and multivariable Poisson regressions, between four treatment arms: 150 µg/kg annually, 800 µg/kg annually, 150 µg/kg 3-monthly, and 800 µg/kg 3-monthly.
RESULTS


The mean number of nodules that appeared during the trial was reduced by 17.7% in subjects treated 3-monthly compared to those treated annually (regardless of the dose). Poisson regression model, adjusting on subject's age and weight, initial number of nodules and intensity of O. volvulus infection in his village of residence, confirmed that the incidence of new nodules was reduced in 3-monthly treatment arms compared to annually treatment arms, and that the dosage of ivermectin does not seem to influence this effect. Furthermore, the number of newly acquired nodules was positively associated with the initial number of nodules. Analysis of disappearance of nodules did not show any significant difference between the treatment groups.
CONCLUSIONS


To our knowledge, these results suggest for the first time in humans, that ivermectin has a partial prophylactic effect on O. volvulus. Three-monthly treatment seems more effective than annual treatment to prevent the appearance of nodules.",2020,The mean number of nodules that appeared during the trial was reduced by 17.7% in subjects treated 3-monthly compared to those treated annually (regardless of the dose).,['Mbam Valley (Cameroon) between 1994 and 1998 in a cohort of onchocerciasis infected individuals'],['ivermectin'],"['mean number of nodules', 'number of nodules']","[{'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0029001', 'cui_str': 'Infection by Onchocerca volvulus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}]",,0.060998,The mean number of nodules that appeared during the trial was reduced by 17.7% in subjects treated 3-monthly compared to those treated annually (regardless of the dose).,"[{'ForeName': 'Jérémy T', 'Initials': 'JT', 'LastName': 'Campillo', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD) and University of Montpellier 1, 911 avenue Agropolis, P.O. Box 64501, 34394, Montpellier Cedex 5, France.'}, {'ForeName': 'Cédric B', 'Initials': 'CB', 'LastName': 'Chesnais', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD) and University of Montpellier 1, 911 avenue Agropolis, P.O. Box 64501, 34394, Montpellier Cedex 5, France.'}, {'ForeName': 'Sébastien D S', 'Initials': 'SDS', 'LastName': 'Pion', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD) and University of Montpellier 1, 911 avenue Agropolis, P.O. Box 64501, 34394, Montpellier Cedex 5, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Gardon', 'Affiliation': 'Hydrosciences Montpellier, Institut de Recherche pour le Développement (IRD), Montpellier, France.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kamgno', 'Affiliation': 'Centre for Research on Filariasis and other Tropical Diseases (CRFilMT), P.O. Box 5797, Yaoundé, Cameroon.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Boussinesq', 'Affiliation': 'UMI 233, Institut de Recherche pour le Développement (IRD) and University of Montpellier 1, 911 avenue Agropolis, P.O. Box 64501, 34394, Montpellier Cedex 5, France. michel.boussinesq@ird.fr.'}]",Parasites & vectors,['10.1186/s13071-020-04126-x']
2064,32414762,"Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab-Letter.",,2020,,['Patients with Metastatic Melanoma'],[],"['Safety, Clinical Activity, and Biological Correlates of Response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]",,0.132608,,"[{'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Goldstein', 'Affiliation': 'Tel Aviv University, Tel Aviv, Israel. danielg3@tauex.tau.ac.il.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Ratain', 'Affiliation': 'The University of Chicago, Chicago, Illinois.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3408']
2065,32414376,Implementation and adoption of a health insurance support tool in the electronic health record: a mixed methods analysis within a randomized trial.,"BACKGROUND


In addition to delivering vital health care to millions of patients in the United States, community health centers (CHCs) provide needed health insurance outreach and enrollment support to their communities. We developed a health insurance enrollment tracking tool integrated within the electronic health record (EHR) and conducted a hybrid implementation-effectiveness trial in a CHC-based research network to assess tool adoption using two implementation strategies.
METHODS


CHCs were recruited from the OCHIN practice-based research network. Seven health center systems (23 CHC clinic sites) were recruited and randomized to receive basic educational materials alone (Arm 1), or these materials plus facilitation (Arm 2) during the 18-month study period, September 2016-April 2018. Facilitation consisted of monthly contacts with clinic staff and utilized audit and feedback and guided improvement cycles. We measured total and monthly tool utilization from the EHR. We conducted structured interviews of CHC staff to assess factors associated with tool utilization. Qualitative data were analyzed using an immersion-crystallization approach with barriers and facilitators identified using the Consolidated Framework for Implementation Research.
RESULTS


The majority of CHCs in both study arms adopted the enrollment tool. The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01). However, by the end of the study period, the rate of tool utilization was similar in both arms; and observed between-arm differences in tool utilization were largely driven by a single, large health center in Arm 2. Perceived relative advantage of the tool was the key factor identified by clinic staff as driving tool utilization. Implementation climate and leadership engagement were also associated with tool utilization.
CONCLUSIONS


Using basic education materials and low-intensity facilitation, CHCs quickly adopted an EHR-based tool to support critical outreach and enrollment activities aimed at improving access to health insurance in their communities. Though facilitation carried some benefit, a CHC's perceived relative advantage of the tool was the primary driver of decisions to implement the tool.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02355262, Posted February 4, 2015.",2020,"The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01).","['Seven health center systems (23 CHC clinic sites', 'CHCs were recruited from the OCHIN practice-based research network']","['health insurance enrollment tracking tool integrated within the electronic health record (EHR', 'basic educational materials alone']",['rate of tool utilization'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1861453', 'cui_str': 'Pseudohyperkalemia Cardiff'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.135831,"The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01).","[{'ForeName': 'Brigit', 'Initials': 'B', 'LastName': 'Hatch', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA. adamusb@ohsu.edu.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Tillotson', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Huguet', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Marino', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baron', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Sumic', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'E DeVoe', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}]",BMC health services research,['10.1186/s12913-020-05317-z']
2066,32414405,"""[Repeat] testing and counseling is one of the key [services] that the government should continue providing"": participants' perceptions on extended repeat HIV testing and enhanced counseling (ERHTEC) for primary HIV prevention in pregnant and lactating women in the PRIMAL study, Uganda.","BACKGROUND


The 'Primary HIV Prevention among Pregnant and Lactating Ugandan Women' (PRIMAL) randomized controlled trial aimed to assess an enhanced counseling strategy linked to extended postpartum repeat HIV testing and enhanced counseling among 820 HIV-negative pregnant and lactating women aged 18-49 years and 410 of their male partners to address the first pillar of the WHO Global Strategy for the Prevention of Mother-to-Child HIV transmission (PMTCT). This paper presents findings of qualitative studies aimed at evaluating participants' and service providers' perceptions on the acceptability and feasibility of the intervention and at understanding the effects of the intervention on risk reduction, couple communication, and emotional support from women's partners.
METHODS


PRIMAL Study participants were enrolled from two antenatal care clinics and randomized 1:1 to an intervention or control arm. Both arms received repeat sexually transmitted infections (STI) and HIV testing at enrolment, labor and delivery, and at 3, 6, 12, 18 and 24 months postpartum. The intervention consisted of enhanced quarterly counseling on HIV risk reduction, couple communication, family planning and nutrition delivered by study counselors through up to 24 months post-partum. Control participants received repeat standard post-test counseling. Qualitative data were collected from intervention women participants, counsellors and midwives at baseline, midline and end of the study through 18 focus group discussions and 44 key informant interviews. Data analysis followed a thematic approach using framework analysis and a matrix-based system for organizing, reducing, and synthesizing data.
RESULTS


At baseline, FGD participants mentioned multiple sexual partners and lack of condom use as the main risks for pregnant and lactating women to acquire HIV. The main reasons for having multiple sexual partners were 1) the cultural practice not to have sex in the late pre-natal and early post-natal period; 2) increased sexual desire during pregnancy; 3) alcohol abuse; 4) poverty; and 5) conflict in couples. Consistent condom use at baseline was limited due to lack of knowledge and low acceptance of condom use in couples. The majority of intervention participants enrolled as couples felt enhanced counselling improved understanding, faithfulness, mutual support and appreciation within their couple. Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use. Participants stressed the importance of providing counselling services to all couples.
CONCLUSION


This study shows that enhanced individual and couple counselling linked to extended repeat HIV and STI testing and focusing on HIV prevention, couple communication, family planning and nutrition is a feasible and acceptable intervention that could enhance risk reduction programs among pregnant and lactating women.
TRIAL REGISTRATION


ClinicalTrials.gov registration number NCT01882998, date of registration 21st June 2013.",2020,"Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use.","[""women's partners"", '820 HIV-negative pregnant and lactating women aged 18-49\u2009years and 410 of their male partners to address the first pillar of the WHO Global Strategy for the Prevention of Mother-to-Child HIV transmission (PMTCT', 'PRIMAL Study participants were enrolled from two antenatal care clinics', 'pregnant and lactating women in the PRIMAL study, Uganda', 'pregnant and lactating women', 'Pregnant and Lactating', 'Ugandan Women']","['enhanced quarterly counseling on HIV risk reduction, couple communication, family planning and nutrition delivered by study counselors through up to 24\u2009months post-partum', 'enhanced counseling strategy linked to extended postpartum repeat HIV testing and enhanced counseling', 'Repeat] testing and counseling', 'repeat standard post-test counseling']","['risk reduction, couple communication, and emotional support', 'understanding, faithfulness, mutual support and appreciation within their couple']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C3714360', 'cui_str': 'Counseling strategy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",,0.0739136,"Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use.","[{'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Bannink Mbazzi', 'Affiliation': 'Medical Research Council / Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine Uganda Research Unit, P.O. Box 49, Entebbe, Uganda. femke.bannink@mrcuganda.org.'}, {'ForeName': 'Zikulah', 'Initials': 'Z', 'LastName': 'Namukwaya', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Amone', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Ojok', 'Affiliation': 'AVSI Foundation, Kampala, Uganda.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Etima', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Byamugisha', 'Affiliation': 'Department of Obstetrics and Gynecology, Makerere University School of Medicine, Kampala, Uganda.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Katabira', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jaco', 'Initials': 'J', 'LastName': 'Homsy', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC public health,['10.1186/s12889-020-08738-x']
2067,32414414,"Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial.","BACKGROUND


Insomnia seriously affects people's normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney.
DESIGN


This is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 124 participants suffering from insomnia symptoms will be randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of the drug intervention. The primary outcome measures will be the mean change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to the end of the drug intervention. Secondary outcome measures will include the altered sleep parameters in polysomnography,  1 H-magnetic resonance spectroscopy ( 1 H-MRS) evaluation, the Disharmony of Heart and Kidney Scoring System score, and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW.
DISCUSSION


The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800019239. Registered on 1st November 2018.",2020,"The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW.
",['124 participants suffering from insomnia symptoms'],"['JTW or placebo', 'Jiao-tai-wan (JTW', 'JTW', 'placebo']","['mean change in the Pittsburgh Sleep Quality Index (PSQI', 'altered sleep parameters in polysomnography,  1 H-magnetic resonance spectroscopy ( 1 H-MRS) evaluation, the Disharmony of Heart and Kidney Scoring System score, and blood tests, including the levels of serum adenosine and melatonin']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C3849168', 'cui_str': 'jiao tai wan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]",124.0,0.462694,"The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW.
","[{'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang, Ouhai District, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Zhejiang Chinese Medical University, Binwen Road, Binjiang District, Zhejiang, 310053, Hangzhou, China.'}, {'ForeName': 'Lufeng', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Department of Pharm, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'The 2nd Clinical College of Wenzhou Medical University, Chashan Higher Education Park, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Nengzhi', 'Initials': 'N', 'LastName': 'Xia', 'Affiliation': 'X-ray Department, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Haihuan', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Sleep monitoring center, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325035, Zhejiang, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Research Institute of China Academy of Chinese Medical Sciences, No.16 Nanxiao Street, Dongzhimen, Dongcheng District, Beijing, 100700, China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Ye', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang, Ouhai District, Wenzhou, 325035, Zhejiang, China. yeren601@163.com.'}, {'ForeName': 'Zhengzhong', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Department of Traditional Chinese Medicine, The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang, Ouhai District, Wenzhou, 325035, Zhejiang, China. wzyzz2008@126.com.'}]",Trials,['10.1186/s13063-020-04299-x']
2068,32414425,Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis.,"BACKGROUND


In clinical practice, temporary interruption of rheumatoid arthritis (RA) therapy is common for various reasons including side effects, non-compliance, or necessity for surgery. To characterize temporary interruptions of baricitinib and placebo-matched tablets in phase 3 studies of patients with moderate-to-severe rheumatoid arthritis (RA) and describe their impact on efficacy and safety.
METHODS


During 4 baricitinib phase 3 studies, investigators documented timing, reason, and duration of investigator-initiated temporary interruptions of study drug. In 2 studies, patients recorded RA symptoms in daily diaries for 12 weeks. Post hoc analyses investigated changes in symptom scores during interruptions and resumption of treatment. Interruptions were evaluated for reoccurrence of adverse events or laboratory abnormalities after retreatment.
RESULTS


Across the placebo-controlled studies, interruptions occurred in larger proportions of baricitinib- (2 mg, 18%; 4 mg, 18%) vs placebo-treated (9%) patients in only one study (bDMARD-inadequate responder patients, RA-BEACON). In the active comparator-controlled studies, the lowest rates of interruption were in the baricitinib monotherapy arm (9%) of RA-BEGIN (vs methotrexate monotherapy or combination therapy), and proportions were similar for baricitinib (10%) and adalimumab (9%) in RA-BEAM. Adverse events were the most common reason for interruption, but their reoccurrence after drug restart was infrequent. Most interruptions lasted ≤ 2 weeks. Daily diaries indicated modest symptom increases during interruption with return to pre-interruption levels or better after resumption. Interruptions had no impact on long-term efficacy outcomes.
CONCLUSIONS


Consistent with its pharmacologic properties, brief interruptions of baricitinib during phase 3 studies were associated with minor increases in RA symptoms that resolved following retreatment. This analysis provides useful information for clinicians, as temporary interruption of antirheumatic therapy is common in the care of patients with RA.
TRIAL REGISTRATION


ClinicalTrials.gov; NCT01710358, NCT01711359, NCT01721057, NCT01721044.",2020,"Interruptions had no impact on long-term efficacy outcomes.
","['patients with rheumatoid arthritis', 'patients with moderate-to-severe rheumatoid arthritis (RA', 'patients with RA']","['baricitinib', 'baricitinib and placebo-matched tablets', 'adalimumab']","['Adverse events', 'long-term efficacy outcomes', 'efficacy and safety', 'RA symptoms', 'reoccurrence of adverse events or laboratory abnormalities', 'symptom scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.490948,"Interruptions had no impact on long-term efficacy outcomes.
","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Muscoloskeletal Biomedical Research Centre/Chapel Allerton Hospital, Chapeltown Rd, Leeds, LS7 4SA, UK. P.Emery@leeds.ac.uk.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Cardillo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Schlichting', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Rooney', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Beattie', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Helt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.'}]",Arthritis research & therapy,['10.1186/s13075-020-02199-8']
2069,32414763,"Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab-Response.",,2020,,['Patients with Metastatic Melanoma'],[],"['Safety, Clinical Activity, and Biological Correlates of Response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]",,0.131922,,"[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'The Angeles Clinic and Research Institute, Los Angeles, California.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': 'Genentech, Inc., Marseille, France.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Fasso', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': ""O'Hear"", 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Genentech, Inc., Marseille, France.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0298']
2070,27549570,Effectiveness of a community-based nutrition programme to improve child growth in rural Ethiopia: a cluster randomized trial.,"Few trials have shown that promoting complementary feeding among young children is effective in improving child linear growth in resource-challenged settings. We designed a community-based participatory nutrition promotion (CPNP) programme adapting a Positive Deviance/Hearth approach that engaged mothers in 2-week nutrition sessions using the principles of 'learning by doing' around child feeding. We aimed to test the effectiveness of the CPNP for improving child growth in rural Ethiopia. A cluster randomized trial was implemented by adding the CPNP to the existing government nutrition programmes (six clusters) vs. government programmes only (six clusters). A total of 1790 children aged 6 to 12 months (876 in the intervention and 914 in the control areas) were enrolled and assessed on anthropometry every 3 months for a year. Multi-level mixed-effect regression analysis of longitudinal outcome data (n = 1475) examined the programme impact on growth, adjusting for clustering and enrollment characteristics. Compared with children 6 to 24 months of age in the control area, those in the intervention area had a greater increase in z scores for length-for-age [difference (diff): 0.021 z score/month, 95% CI: 0.008, 0.034] and weight-for-length (diff: 0.042 z score/month, 95% CI: 0.024, 0.059). At the end of the 12-month follow-up, children in the intervention area showed an 8.1% (P = 0.02) and 6.3% (P = 0.046) lower prevalence of stunting and underweight, respectively, after controlling for differences in the prevalence at enrollment, compared with the control group. A novel CPNP programme was effective in improving child growth and reducing undernutrition in this setting. © 2016 John Wiley & Sons Ltd.",2017,Few trials have shown that promoting complementary feeding among young children is effective in improving child linear growth in resource-challenged settings.,"['child growth in rural Ethiopia', 'young children', '1790 children aged 6 to 12\u2009months (876 in the intervention and 914 in the control areas']","['CPNP programme', 'CPNP', 'community-based participatory nutrition promotion (CPNP) programme', 'community-based nutrition programme']","['weight-for-length', 'child growth and reducing undernutrition', 'z scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",1790.0,0.071819,Few trials have shown that promoting complementary feeding among young children is effective in improving child linear growth in resource-challenged settings.,"[{'ForeName': 'Yunhee', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Sungtae', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'International Ministry Division, World Vision Korea, Seoul, Korea.'}, {'ForeName': 'Sisay', 'Initials': 'S', 'LastName': 'Sinamo', 'Affiliation': 'East Africa Regional Office, World Vision International, Addis Ababa, Ethiopia.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Christian', 'Affiliation': 'Global Development, Bill & Melinda Gates Foundation, Seattle, Washington, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12349']
2071,32414817,Broader impacts of an intervention to transform school environments on student behaviour and school functioning: post hoc analyses from the INCLUSIVE cluster randomised controlled trial.,"BACKGROUND


We have previously reported benefits for reduced bullying, smoking, alcohol and other drug use and mental health from a trial of 'Learning Together', an intervention that aimed to modify school environments and implement restorative practice and a social and emotional skill curriculum.
OBJECTIVES


To conduct post hoc theory-driven analyses of broader impacts.
DESIGN


Cluster randomised trial.
SETTINGS


40 state secondary schools in southern England.
PARTICIPANTS


Students aged 11/12 years at baseline.
OUTCOMES


Student self-reported measures at 24 and 36 months of: cyberbullying victimisation and perpetration; observations of other students perpetrating aggressive behaviours at school; own perpetration of aggressive behaviours in and outside school; perceived lack of safety at school; participation in school disciplinary procedures; truancy and e-cigarette use.
RESULTS


We found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes.
CONCLUSION


These analyses suggested that the intervention was effective in bringing about a broader range of beneficial outcomes, adding to the evidence that the intervention is a promising approach to promote adolescent health via an intervention that is attractive to schools.
TRIAL REGISTRATION NUMBER


ISRCTN10751359.",2020,"We found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes.
","['Students aged 11/12 years at baseline', '40 state secondary schools in southern England']",[],"['student behaviour and school functioning', 'aggressive behaviours in and outside school; perceived lack of safety at school; participation in school disciplinary procedures; truancy and e-cigarette use']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0014282', 'cui_str': 'England'}]",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0424357', 'cui_str': 'Truancy'}, {'cui': 'C4083280', 'cui_str': 'Vape'}]",,0.182719,"We found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes.
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK chris.bonell@lshtm.ac.uk.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dodd', 'Affiliation': 'Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bevilacqua', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McGowan', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Opondo', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Sturgess', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Elbourne', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Warren', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Russell M', 'Initials': 'RM', 'LastName': 'Viner', 'Affiliation': 'Population, Policy and Practice Research Programme, UCL Institute of Child Health, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031589']
2072,27647837,Adherence to a lifestyle programme in overweight/obese pregnant women and effect on gestational diabetes mellitus: a randomized controlled trial.,"This study aims to determine whether the prescription of a detailed lifestyle programme in overweight/obese pregnant women influences the occurrence of gestational diabetes (GDM), and if this kind of prescription increases the adherence to a healthier lifestyle in comparison to standard care. The study was designed as a randomized controlled trial, with open allocation, enrolling women at 9-12 weeks of pregnancy with a BMI ≥ 25 kg/m 2  . The women assigned to the Intervention group (I = 96) received a hypocaloric, low-glycaemic, low-saturated fat diet and physical activity recommendations. Those assigned to the Standard Care group (SC = 95) received lifestyle advices regarding healthy nutrition and exercise. Follow-up was planned at the 16 th  , 20 th  , 28 th  and 36 th  weeks. A total of 131 women completed the study (I = 69, SC = 62). The diet adherence was higher in the I (57.9%) than in the SC (38.7%) group. GDM occurred less frequently in the I (18.8%) than in the SC (37.1%, P = 0.019) group. The adherent women from either groups showed a lower GDM rate (12.5% vs. 41.8%, P < 0.001). After correcting for confounders, the GDM rate was explained by allocation into the I group (P = 0.034) and a lower BMI category (P = 0.039). The rates of hypertension, preterm birth, induction of labour, large for gestational age babies and birthweight > 4000 g were significantly lower in I group. The incidence of small for gestational age babies was not different. These findings demonstrate that the adherence to a personalized, hypocaloric, low-glycaemic, low-saturated fat diet started early in pregnancy prevents GDM occurrence, in women with BMI ≥ 25 kg/m 2  .",2017,"After correcting for confounders, the GDM rate was explained by allocation into the I group (P = 0.034) and a lower BMI category (P = 0.039).","['131 women completed the study (I\u2009=\u200969, SC\u2009=\u200962', 'overweight/obese pregnant women and effect on gestational diabetes mellitus', 'overweight/obese pregnant women influences the occurrence of gestational diabetes (GDM', 'enrolling women at 9-12\u2009weeks of pregnancy with a BMI\u2009≥\u200925\u2009kg/m 2  ']","['lifestyle programme', 'hypocaloric, low-glycaemic, low-saturated fat diet and physical activity recommendations', 'detailed lifestyle programme', 'Standard Care group (SC\u2009=\u200995) received lifestyle advices regarding healthy nutrition and exercise']","['GDM rate', 'rates of hypertension, preterm birth, induction of labour, large for gestational age babies and birthweight\u2009>\u20094000\u2009g', 'diet adherence', 'GDM', 'incidence of small for gestational age babies']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C1848395', 'cui_str': 'Large for gestational age'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021296', 'cui_str': 'Infant, Small for Gestational Age'}]",131.0,0.069729,"After correcting for confounders, the GDM rate was explained by allocation into the I group (P = 0.034) and a lower BMI category (P = 0.039).","[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': 'Mother-Infant Department, University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Petrella', 'Affiliation': 'Mother-Infant Department, University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Bertarini', 'Affiliation': 'Mother-Infant Department, University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Pedrielli', 'Affiliation': 'Mother-Infant Department, University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Neri', 'Affiliation': 'Mother-Infant Department, University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Facchinetti', 'Affiliation': 'Mother-Infant Department, University of Modena and Reggio Emilia, Italy.'}]",Maternal & child nutrition,['10.1111/mcn.12333']
2073,32416495,Changing the future: An initial test of Future Specificity Training (FeST).,"A range of psychiatric disorders are characterised by impairments in episodic future thinking (EFT), and particularly simulating specific, spatiotemporally-located future events. No study has examined whether training can lead to sustained improvement in specific EFT. In this study, participants (N = 60; M age = 31, SD = 13.2) were randomized to a two-session, group-based future thinking program (Future Specificity Training; FeST) or wait-list. At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (d = 1.32), use of mental imagery (d = 1.32), anticipated (d = 1.78) and anticipatory pleasure (d = 1.07), perceived control (d = 1.20), and likelihood of occurrence (d = 1.09). Some effects were also observed on positive, generalised future self-states. In the context of inherent limitations of subjective reporting in trials, this study provides evidence that EFT specificity can be enhanced, and the effects of FeST indicate a possible avenue to disrupt psychopathological processes.",2020,"At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (","['participants (N\xa0=\xa060; M age\xa0=\xa031, SD\xa0=\xa013.2']","['group-based future thinking program (Future Specificity Training; FeST) or wait-list', 'Future Specificity Training (FeST']","['anticipatory pleasure', 'detail ', 'ability to mentally simulate specific EFT']","[{'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",,0.0143698,"At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (","[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Hallford', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia. Electronic address: david.hallford@deakin.edu.au.'}, {'ForeName': 'J J E', 'Initials': 'JJE', 'LastName': 'Yeow', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fountas', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Herrick', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Raes', 'Affiliation': 'Faculty of Psychology and Educational Sciences, KU Leuven, Tiensestraat 102, Box 3712, 3000, Leuven, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': ""D'Argembeau"", 'Affiliation': 'Psychology and Neuroscience of Cognition Research Unit, Department of Psychology, University of Liège, Belgium and Fonds de La Recherche Scientifique (F.R.S.-FNRS), Belgium.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103638']
2074,32416442,"Acute inspiratory muscle exercise effect on glucose levels, glucose variability and autonomic control in patients with type 2 diabetes: A crossover randomized trial.","Inspiratory muscle exercise (IME) can be an alternative to conventional exercise. We aimed to evaluate the effect of IME on glucose, glucose variability, and autonomic cardiovascular control in type 2 diabetes. Fourteen diabetic subjects were randomly assigned to IME with 2% maximal inspiratory pressure (PImax) or 60% PImax wearing a continuous glucose monitoring system for three days. Glucose variability [glucose variance (VAR), glucose coefficient of variation (CV%), glucose standard deviation (SD), and mean amplitude of glycemic excursions (MAGE)] were evaluated. Glucose reduction was observed in 5 min (60% of PImax 33.2% and 2% of PImax 32.0%), 60 min (60% of PImax 29.6% and 2% of PImax 31.4%) and 120 min (60% of PImax 21.4% and 2% of PImax 24.0%) after IME (vs.1 h before the exercise), with no difference between loads. This reduction in glucose levels was observed in all moments of the IME protocol. Glucose variability was reduced after 12 h and 18 h of the IME (ΔCV: P < 0.001, ΔSD: P < 0.001 and ΔVAR: P < 0.001) for both loads. No difference was found in MAGE (P = 0.594) after IME. Mean arterial pressure and heart rate rose during the exercise session with 60% of PImax. Although sufficiently strong to induce cardiovascular changes, an inspiratory muscle exercise session with 60% of PImax in subjects with type 2 diabetes has failed to induce any significant improvement in glucose, glucose variability and autonomic control, compared to the 2% Plmax exercise session.",2020,"Glucose variability was reduced after 12 h and 18 h of the IME (ΔCV: P < 0.001, ΔSD:","['2 diabetes', 'subjects with type 2 diabetes', 'Fourteen diabetic subjects', 'type 2 diabetes', 'patients with type']","['Acute inspiratory muscle exercise', 'Inspiratory muscle exercise (IME', 'IME with 2% maximal inspiratory pressure (PImax) or 60% PImax wearing a continuous glucose monitoring system', 'IME']","['glucose, glucose variability and autonomic control', 'Glucose reduction', 'MAGE', 'Glucose variability [glucose variance (VAR), glucose coefficient of variation (CV%), glucose standard deviation (SD), and mean amplitude of glycemic excursions (MAGE', 'Mean arterial pressure and heart rate', 'glucose, glucose variability, and autonomic cardiovascular control', 'glucose levels', 'Glucose variability', 'glucose levels, glucose variability and autonomic control']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",14.0,0.0238522,"Glucose variability was reduced after 12 h and 18 h of the IME (ΔCV: P < 0.001, ΔSD:","[{'ForeName': 'Andressa S O', 'Initials': 'ASO', 'LastName': 'Schein', 'Affiliation': 'Postgraduate Program in Cardiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil; Exercise Pathophysiology Research Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. Electronic address: andressasilveiradeoliveira@yahoo.com.br.'}, {'ForeName': 'Ana P S', 'Initials': 'APS', 'LastName': 'Corrêa', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Aline C P', 'Initials': 'ACP', 'LastName': 'Macedo', 'Affiliation': 'Postgraduate Program in Endocrinology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil; Exercise Pathophysiology Research Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Daniela R', 'Initials': 'DR', 'LastName': 'Dartora', 'Affiliation': 'Sainte-Justine University Hospital Research Center, University of Montreal Depatment of pediatrics, Montreal, Quebec, Canada.'}, {'ForeName': 'Anderson Donelli', 'Initials': 'AD', 'LastName': 'da Silveira', 'Affiliation': 'Postgraduate Program in Cardiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Mateus Dornelles', 'Initials': 'MD', 'LastName': 'Severo', 'Affiliation': 'Postgraduate Program in Endocrinology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Karina R', 'Initials': 'KR', 'LastName': 'Casali', 'Affiliation': 'Institute of Science and Technology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Beatriz D', 'Initials': 'BD', 'LastName': 'Schaan', 'Affiliation': 'Postgraduate Program in Cardiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil; Postgraduate Program in Endocrinology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil; Exercise Pathophysiology Research Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; Department of Internal Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]",Autonomic neuroscience : basic & clinical,['10.1016/j.autneu.2020.102669']
2075,32415211,Comparison of the use of opioids only and pregabalin add-on for the treatment of neuropathic pain in cervical myelopathy patients: a pilot trial.,"Among patients with cervical myelopathy who were diagnosed with neuropathic pain (NP) by the LANSS test, the study participants were randomly assigned to one of the two study groups. The participants in one study group received opioids only, while those in the other group received opioids and pregabalin. Thirty-nine patients were analyzed in the study (20 patients in the opioid-only group and 19 in the pregabalin add-on group). The LANSS, neck pain, and arm pain scores in the pregabalin add-on group improved significantly compared with those in the opioid-only group after the first 4 weeks (p = 0.005, 0.001 and 0.035, respectively), but there was no significant difference between the two groups during the next 4 weeks (p = 0.615, 0.377 and 0.716, respectively). There was no significant difference in the neck disability index and EuroQol-5Dimension scores after four weeks and eight weeks of follow-up. Adverse events were reported by four patients (20.0%) in the opioid-only group and five patients (26.3%) in the pregabalin add-on group (p = 0.716). However, over time, the occurrence of side effects and dropouts increased in the pregabalin add-on group. This exploratory pilot study suggests that pregabalin add-on treatment is more efficient than the use of opioids alone at the beginning of NP treatment in cervical myelopathy patients. However, prescribing pregabalin add-on treatment for more than four weeks should be done cautiously.",2020,There was no significant difference in the neck disability index and EuroQol-5Dimension scores after four weeks and eight weeks of follow-up.,"['cervical myelopathy patients', 'patients with cervical myelopathy who were diagnosed with neuropathic pain (NP) by the LANSS test, the study participants', 'Thirty-nine patients were analyzed in the study (20 patients in the opioid-only group and 19 in the pregabalin add-on group']","['opioids only and pregabalin', 'pregabalin', 'opioids', 'opioids and pregabalin']","['LANSS, neck pain, and arm pain scores', 'neuropathic pain', 'neck disability index and EuroQol-5Dimension scores', 'Adverse events']","[{'cui': 'C0149645', 'cui_str': 'Cervical myelopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}]","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",39.0,0.0383874,There was no significant difference in the neck disability index and EuroQol-5Dimension scores after four weeks and eight weeks of follow-up.,"[{'ForeName': 'Jong-Myung', 'Initials': 'JM', 'LastName': 'Jung', 'Affiliation': 'Department of Neurosurgery, Spine Center, Gachon University Gil Medical Center, Incheon, Republic of Korea.'}, {'ForeName': 'Chun Kee', 'Initials': 'CK', 'LastName': 'Chung', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. chungc@snu.ac.kr.'}, {'ForeName': 'Chi Heon', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Heon', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yunhee', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Division of Medical Statistics, Medical Research Collaborating Center, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]",Scientific reports,['10.1038/s41598-020-65108-8']
2076,32414901,Methylphenidate Effects on Cortical Thickness in Children and Adults with Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial.,"BACKGROUND AND PURPOSE


Although methylphenidate is frequently used to treat children with attention-deficit/hyperactivity disorder, it is currently unknown how methylphenidate affects brain development. In a randomized controlled trial, we investigated whether the cortical effects of methylphenidate are modulated by age.
MATERIALS AND METHODS


Between June 1, 2011, and June 15, 2015, we conducted a randomized, double-blind, placebo-controlled trial (Effects of Psychotropic Drugs on Developing Brain-Methylphenidate) in 99 males with attention-deficit/hyperactivity disorder (according to  Diagnostic and Statistical Manual of Mental Disorders, 4th Edition , criteria) from referral centers in the greater Amsterdam area in the Netherlands. The trial was registered on March 24, 2011 (identifier NL34509.000.10) and subsequently at the Netherlands National Trial Register (identifier NTR3103). Participants (first enrolled October 13, 2011) were 10-12 years or 23-40 years of age and randomized to treatment with either methylphenidate or a placebo for 16 weeks. Our main outcome was a change in cortical thickness in predefined ROIs as measured by MR imaging pre- and posttreatment.
RESULTS


We observed a time × medication × age interaction ( F [1,88.825] = 4.316,  P  < .05) for the right medial cortex ROI, where methylphenidate treatment yielded less cortical thinning in children, but not in adults or the placebo groups.
CONCLUSIONS


Our finding that the effects of methylphenidate on right medial cortical thickness differ between children and adults infers that the drug affects gray matter development in this brain region. This warrants replication in larger groups with longer follow-up to determine whether this effect can also be observed in other cortical brain regions and whether it may have long-term consequences.",2020,"We observed a time × medication × age interaction ( F [1,88.825] = 4.316,  P  < .05) for the right medial cortex ROI, where methylphenidate treatment yielded less cortical thinning in children, but not in adults or the placebo groups.
","['children with attention-deficit/hyperactivity disorder', 'Children and Adults with Attention-Deficit/Hyperactivity Disorder', 'Participants (first enrolled October 13, 2011) were 10-12\u2009years or 23-40\u2009years of age and randomized to treatment with either', '99 males with attention-deficit/hyperactivity disorder (according to  Diagnostic and Statistical Manual of Mental Disorders, 4th Edition , criteria) from referral centers in the greater Amsterdam area in the Netherlands']","['methylphenidate', 'Methylphenidate', 'Psychotropic Drugs', 'methylphenidate or a placebo', 'placebo']","['Cortical Thickness', 'right medial cortical thickness', 'cortical thinning', 'cortical thickness in predefined ROIs', 'Developing Brain-Methylphenidate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]",99.0,0.743922,"We observed a time × medication × age interaction ( F [1,88.825] = 4.316,  P  < .05) for the right medial cortex ROI, where methylphenidate treatment yielded less cortical thinning in children, but not in adults or the placebo groups.
","[{'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Walhovd', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Amlien', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schrantee', 'Affiliation': 'Department of Radiology and Nuclear Medicine (A.S., A.B., L.R.), Amsterdam UMC, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Rohani', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Groote', 'Affiliation': 'Diagnostic Physics (I.G., A.B.), Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bjørnerud', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Fjell', 'Affiliation': 'From the Department of Psychology (K.B.W., I.A., D.A.R., A.B., A.M.F.), Center for Lifespan Changes in Brain and Cognition.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Reneman', 'Affiliation': 'Department of Radiology and Nuclear Medicine (A.S., A.B., L.R.), Amsterdam UMC, Academic Medical Center, Amsterdam, the Netherlands. l.reneman@amsterdamumc.nl.'}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A6560']
2077,31819304,Usage of Probiotics and its Clinical Significance at Surgically Treated Patients Sufferig from Colorectal Carcinoma.,"Introduction


Colorectal Cancer (CRC) is the third most common malignant disease and the fourth most common cause of death associated with malignancy. Adenocarcinomas account for 95% of all cases of colon cancer. Treatment usually includes a surgical resection which is preceded or followed by chemotherapy and radiotherapy depending on the stage. There is constant interest in the microbiological ecosystem of the intestine, which is considered to be crucial for the onset and progression of the disease as well as the development of postoperative complications. Iatrogenic factors associated with the treatment of CRC may result in pronounced expression of virulence of the bacterial intestinal flora and fulminant inflammatory response of the host which ultimately leads to adverse treatment results. The modulation of intestinal microflora by probiotics seems to be an effective method of reducing complications in surgical patients. The question is whether ordering probiotics can lead to more favourable treatment outcomes for our patients who are operated due to colorectal adenocarcinoma, and whether this should become common practice.
Aim


To demonstrate the clinical significance of probiotic administration in patients treated for colorectal adenocarcinoma and the results compared with relevant studies.
Patients and Methods


In a randomized controlled prospective study conducted at the Clinic of General and Abdominal Surgery of the UCCS in the period of 01 January 2017 until 31 December 2017, there were a total of 78 patients with colorectal adenocarcinoma. Patients were divided into two groups: a group treated with oral probiotics (n = 39) according to the 2x1 scheme starting from the third postoperative day lasting for the next thirty days, followed by 1x1 lasting for two weeks in each subsequent month to one year, and the control group (n = 39) which was not routinely treated with probiotics.
Results


A statistically significant difference in the benefit of using probiotics was found during postoperative hospitalization and the occurrence of fatal outcome in the first six months. All complications were more present in the group of patients untreated with probiotic, with statistical significance shown only in the case of ileus. Probiotic has a statistically significant reduction in postoperative complications in the localization of tumours on the rectum -33.3% and the ascending colon -16.7%.
Conclusion


There is a significant benefit of administering probiotics in surgically treated patients for colorectal adenocarcinoma.",2019,"Probiotic has a statistically significant reduction in postoperative complications in the localization of tumours on the rectum -33.3% and the ascending colon -16.7%.
","['surgically treated patients for colorectal adenocarcinoma', 'Clinic of General and Abdominal Surgery of the UCCS in the period of 01 January 2017 until 31 December 2017, there were a total of 78 patients with colorectal adenocarcinoma', 'Surgically Treated Patients Sufferig from Colorectal Carcinoma', 'surgical patients', 'patients who are operated due to colorectal adenocarcinoma', 'patients treated for colorectal adenocarcinoma']","['oral probiotics', 'surgical resection which is preceded or followed by chemotherapy and radiotherapy']","['postoperative complications', 'postoperative hospitalization and the occurrence of fatal outcome']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1319315', 'cui_str': 'Adenocarcinoma of large intestine'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009402', 'cui_str': 'Colorectal Carcinoma'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0206277', 'cui_str': 'Fatal Outcome'}]",78.0,0.0342835,"Probiotic has a statistically significant reduction in postoperative complications in the localization of tumours on the rectum -33.3% and the ascending colon -16.7%.
","[{'ForeName': 'Salem', 'Initials': 'S', 'LastName': 'Bajramagic', 'Affiliation': 'Clinic for General and Abdominal Surgery, Clinical Center University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Edin', 'Initials': 'E', 'LastName': 'Hodzic', 'Affiliation': 'Clinic for General and Abdominal Surgery, Clinical Center University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Mulabdic', 'Affiliation': 'Clinic for General and Abdominal Surgery, Clinical Center University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Sandin', 'Initials': 'S', 'LastName': 'Holjan', 'Affiliation': 'Clinic for General and Abdominal Surgery, Clinical Center University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Sajra Vincevic', 'Initials': 'SV', 'LastName': 'Smajlovic', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Ajdin', 'Initials': 'A', 'LastName': 'Rovcanin', 'Affiliation': 'Clinic for General and Abdominal Surgery, Clinical Center University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}]","Medical archives (Sarajevo, Bosnia and Herzegovina)",['10.5455/medarh.2019.73.316-320']
2078,31562406,Can we deliver effective alcohol-related brief advice in general dental practice?,"Design Two-arm cluster randomised controlled feasibility trial. Intervention Twelve NHS dental practices were randomised to the intervention and control arms. Patients consuming alcohol above the recommended levels were eligible to participate in the trial. The intervention was delivered by the dentists in the participating practices and entailed the delivery of a short tailored alcohol-related advice tool and a leaflet, which included information about the effects of alcohol on oral health and the benefits of reducing alcohol intake to both oral and general health. Patients in the control arm were given a mouth cancer prevention leaflet only. The level of alcohol consumption was measured by validated tools (AUDIT: Alcohol Use Disorders Identification Test and AUTID-C: Alcohol Use Disorders Identification Test for Consumption). The patients were followed-up after six months by a telephone interview. Outcome Measures The feasibility trial outcomes were the recruitment, retention, eligibility and delivery rate. The primary outcome of the trial was the impact of the intervention in lowering the level of alcohol consumption as captured by the AUDIT tool. Secondary outcomes included health related quality of life and alcohol consumption and abstinence in the last 90 days. The acceptability of the intervention was also assessed.Results The recruitment and retention rate were high (95.4% and 76.9% respectively). At the follow-up, participants in the intervention arm were significantly more likely to report a longer abstinence period (3.2 vs. 2.3 weeks respectively, P = 0.04). Non-significant differences in AUDIT (44.9% vs. 59.8% AUDIT positive respectively, P = 0.053) and AUDIT-C between baseline and follow-up (-0.67 units vs. -0.29 units respectively, P = 0.058) were observed. Results from the process evaluation indicated that the intervention and study procedures were acceptable to dentists and patients.Conclusion According to this study, dentists offering screening for alcohol misuse and brief advice in a primary dental care setting is not only feasible but also well-welcomed by both the dental team and patients.",2019,"At the follow-up, participants in the intervention arm were significantly more likely to report a longer abstinence period (3.2 vs. 2.3 weeks respectively, P = 0.04). Non-significant differences in AUDIT (44.9% vs. 59.8% AUDIT positive respectively, P = 0.053) and AUDIT-C between baseline and follow-up","['Patients consuming alcohol above the recommended levels were eligible to participate in the trial', 'Intervention Twelve NHS dental practices']",['mouth cancer prevention leaflet only'],"['lowering the level of alcohol consumption', 'likely to report a longer abstinence period', 'level of alcohol consumption', 'recruitment, retention, eligibility and delivery rate', 'recruitment and retention rate', 'health related quality of life and alcohol consumption and abstinence in the last 90 days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}]","[{'cui': 'C0153381', 'cui_str': 'Cancer of Mouth'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0811527,"At the follow-up, participants in the intervention arm were significantly more likely to report a longer abstinence period (3.2 vs. 2.3 weeks respectively, P = 0.04). Non-significant differences in AUDIT (44.9% vs. 59.8% AUDIT positive respectively, P = 0.053) and AUDIT-C between baseline and follow-up","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Plessas', 'Affiliation': 'Peninsula Dental School, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nasser', 'Affiliation': ''}]",Evidence-based dentistry,['10.1038/s41432-019-0036-3']
2079,31562408,Does time pressure impact on dentists' diagnostic performance?,"Design A randomised blinded crossover trial.Sample selection Forty local primary care dentists in the south west of England were recruited using a variety of methods. Dentists from NHS, mixed practice, private practice and community services were included. Participants were allocated to four balanced experimental test groups of equal numbers. Block randomisation was used for allocation. The principle researcher was blind to which group a participant was from. The trial was completed using a purpose-made weblink which contained a clinical decision-making exercise. The participants repeated the exercise under increasing time pressure.Data analysis Data analysis was performed independently by the principle researcher. The diagnostic sensitivity and specificity of the decisions made were calculated and statistical analysis preformed. This included paired t-tests to assess differences in self-reported stress and difficulty when the exercise was performed under different time constraints. Mann-Whitney U tests were used to compare differences in the sensitivity and specificity values achieved under the varying time constraints.Results One hundred percent (n = 40) of GDPs who responded to the invitation were eligible and included in the study. Results showed a statistical difference (p <0.001) of both perceived difficulty of the task, and stress experienced when under time pressure. Results showed diagnostic sensitivity to pathological features was significantly worse (p <0.001) under time pressure. Conversely, the specificity of identification of pathology free sites were not affected by the different circumstances.Conclusions Time pressure negatively impacted diagnostic performance and decreased diagnostic sensitivity for all pathological features. Sensitivity to caries-related pathology and periodontal disease-related pathology deteriorated by 40% and 67%, retrospectively.",2019,"Results showed a statistical difference (p <0.001) of both perceived difficulty of the task, and stress experienced when under time pressure.","['Sample selection Forty local primary care dentists in the south west of England were recruited using a variety of methods', 'Results One hundred percent (n = 40) of GDPs who responded to the invitation were eligible and included in the study']",[],"['diagnostic sensitivity to pathological features', 'time pressure', 'sensitivity and specificity values', 'specificity of identification of pathology free sites', 'diagnostic sensitivity']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",,0.10699,"Results showed a statistical difference (p <0.001) of both perceived difficulty of the task, and stress experienced when under time pressure.","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cave', 'Affiliation': 'Glasgow Dental Hospital and School 378 Sauchiehall Street, Glasgow, G2 3JZ, UK. victoria.cave1@nhs.net.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Hutchison', 'Affiliation': 'Glasgow Dental Hospital and School 378 Sauchiehall Street, Glasgow, G2 3JZ, UK.'}]",Evidence-based dentistry,['10.1038/s41432-019-0043-4']
2080,27477840,Lanolin for the treatment of nipple pain in breastfeeding women: a randomized controlled trial.,"Nipple pain and damage are commonly experienced by breastfeeding women and are associated with negative breastfeeding outcomes. Health care providers often recommend the application of lanolin to treat painful/damaged nipples, yet no randomized controlled trial has evaluated the effectiveness of lanolin on nipple pain and breastfeeding outcomes. The purpose of this study was to evaluate the effect of lanolin on nipple pain among breastfeeding women with damaged nipples. A randomized, single-blind, controlled trial was conducted at a tertiary care hospital in Hamilton, Ontario, Canada. Breastfeeding women (N = 186) identified as having nipple pain/damage were randomized to apply lanolin (intervention group; n = 93) or to receive usual postpartum care (control group; n = 93). The primary outcome was nipple pain at 4 days post-randomization measured by the Numeric Rating Scale. Additional outcomes included nipple pain measured by the Short Form McGill Pain Questionnaire, breastfeeding duration/exclusivity, breastfeeding self-efficacy, and maternal satisfaction with lanolin treatment versus usual care. The results revealed no significant group differences in mean pain scores at 4 days post-randomization. Women in both groups experienced clinically relevant decreases in nipple pain by 7 days post-randomization. Significantly, more women in the lanolin group reported that they were satisfied with treatment compared with those receiving usual care. No significant group differences were found for other secondary outcomes. While more women were satisfied using lanolin, its application to sore/damaged nipples was ineffective for reducing nipple pain or improving breastfeeding outcomes.",2017,No significant group differences were found for other secondary outcomes.,"['tertiary care hospital in Hamilton, Ontario, Canada', 'nipple pain in breastfeeding women', 'Breastfeeding women (N\u2009=\u2009186) identified as having nipple pain/damage', 'breastfeeding women with damaged nipples']","['lanolin (intervention group; n\u2009=\u200993) or to receive usual postpartum care (control group; n\u2009=\u200993', 'lanolin', 'Lanolin']","['nipple pain or improving breastfeeding outcomes', 'nipple pain measured by the Short Form McGill Pain Questionnaire, breastfeeding duration/exclusivity, breastfeeding self-efficacy, and maternal satisfaction with lanolin treatment versus usual care', 'mean pain scores', 'nipple pain at 4 days post-randomization measured by the Numeric Rating Scale', 'Nipple pain and damage', 'nipple pain']","[{'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0423637', 'cui_str': 'Sore nipple (finding)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0457424', 'cui_str': 'Nippled (qualifier value)'}]","[{'cui': 'C0023024', 'cui_str': 'Lanolin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032782', 'cui_str': 'Postpartum Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0423637', 'cui_str': 'Sore nipple (finding)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire (assessment scale)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023024', 'cui_str': 'Lanolin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0222045'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}]",,0.136839,No significant group differences were found for other secondary outcomes.,"[{'ForeName': 'Kimberley T', 'Initials': 'KT', 'LastName': 'Jackson', 'Affiliation': 'University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Cindy-Lee', 'Initials': 'CL', 'LastName': 'Dennis', 'Affiliation': ""Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Canada and Women's Health Research Chair, St. Michael's Hospital, Toronto, Canada.""}]",Maternal & child nutrition,['10.1111/mcn.12357']
2081,27356547,Effects of maternal vitamin B12 supplementation on early infant neurocognitive outcomes: a randomized controlled clinical trial.,"Maternal nutritional status during pregnancy impacts fetal brain development. Vitamin B12 plays a vital role in neuronal development. However, findings from studies on the association between maternal B12 status and child cognitive functions have been inconsistent. We performed a randomized, placebo-controlled clinical trial of oral B12 supplementation (50 µg) beginning at <14 weeks of gestation through a 6-week post-partum. In the present study, we report the effects of maternal B12 supplementation on cognitive development in infants at 9 months of age on Bayley Scales of Infant Development-III (BSID-III). One hundred eighty-three pregnant women received vitamin B12, and 183 received placebo. Nine-month BSID-III development score was available in 178 infants. There were no significant differences in maternal sociodemographic characteristics and baseline biochemical measures between infants who underwent BSID-III evaluation and infants who were not evaluated. There were no significant differences in any of the subscales of BSID-III between infants born to mothers who received B12 supplementation (n = 78) vs. placebo (n = 100). On multiple regression analysis, elevated maternal total homocysteine (tHcy) levels adjusted for treatment group, birthweight, parity, income and home environment at second trimester of pregnancy were significantly negatively associated with expressive language (β = 3.13 points, P < 0.001), and in third trimester of pregnancy with expressive language (β = -2.29 points, P < 0.001) and fine motor (β = -1.41 points, P = 0.005) domains of BSID-III. While no significant effects of maternal B12 supplementation were seen on cognitive development in infants at 9 months of age, elevated maternal tHcy levels were associated with poorer cognitive performance in some of the subdomains of BSID-III. In pregnant women with elevated tHcy levels and or B12 deficiencies, it may be worthwhile to study the impact of longer term maternal supplementation on infant cognitive outcomes.",2017,There were no significant differences in maternal sociodemographic characteristics and baseline biochemical measures between infants who underwent BSID-III evaluation and infants who were not evaluated.,"['pregnant women with elevated tHcy levels and or B12 deficiencies', 'infants at 9\u2009months of age on Bayley Scales of Infant Development-III', 'One hundred eighty-three pregnant women received', '178 infants']","['placebo', 'maternal vitamin B12 supplementation', 'B12 supplementation', 'oral B12 supplementation', 'vitamin B12', 'maternal B12 supplementation']","['cognitive performance', 'expressive language', 'early infant neurocognitive outcomes', 'subscales of BSID-III', 'birthweight, parity, income and home environment at second trimester of pregnancy', 'cognitive development', 'maternal sociodemographic characteristics and baseline biochemical measures', 'maternal total homocysteine (tHcy) levels', 'maternal B12 supplementation', 'Maternal nutritional status']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4524262', 'cui_str': 'Vitamin B12 supplementation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0032980', 'cui_str': 'Midtrimester'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}]",183.0,0.250541,There were no significant differences in maternal sociodemographic characteristics and baseline biochemical measures between infants who underwent BSID-III evaluation and infants who were not evaluated.,"[{'ForeName': 'Krishnamachari', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Tinku', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': ""Division of Epidemiology, Biostatistics and Population Health, St. John's Research Institute, Bangalore, Karnataka, India.""}, {'ForeName': 'Aruna Rose Mary', 'Initials': 'AR', 'LastName': 'Kapanee', 'Affiliation': 'Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, India.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Ramthal', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Bellinger', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Bosch', 'Affiliation': 'Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Bangalore, Karnataka, India.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Duggan', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Bangalore, Karnataka, India.""}]",Maternal & child nutrition,['10.1111/mcn.12325']
2082,31561881,Comparison of the Level of Free Hexafluoro-isopropanol in Adults' Blood and the Incidence of Emergence Agitation After Anesthesia With Different Concentrations of Sevoflurane in Laparoscopic Gastrointestinal Surgery: A Randomized Controlled Clinical Trial.,"PURPOSE


The aim of the study is to compare the free hexafluoro-isopropanol (HFIP) concentration in adults' blood and the incidence of emergence agitation (EA) after inhaled different concentrations of sevoflurane.
METHODS


Sixty adult patients planning to undergo laparoscopic gastrointestinal surgery were randomly assigned to 3 groups. Each group received sevoflurane as the volatile anesthetic at different concentrations: 0.5 minimum alveolar concentration (MAC), 1.0 MAC, and 1.5 MAC. The use of sevoflurane was continued until the end of surgery. Venous blood samples were obtained at 30, 60, 120, and 180 minutes after starting the use of sevoflurane and subsequently at 60, 180, and 300 minutes after discontinuation of volatile anesthetic administration. Blood concentrations of sevoflurane and free HFIP were determined using gas chromatography. The recovery time and the incidence of EA at different time points were evaluated among the 3 groups.
FINDINGS


Changes in the blood concentrations of sevoflurane and free HFIP during and after the use of sevoflurane were similar in all 3 groups. The peak blood concentration of free HFIP occurred 60 minutes after onset of sevoflurane anesthesia in all 3 groups (P < 0.05). The lowest level of free HFIP and the longest recovery time were found in the 1.5-MAC group (P < 0.05). No significant difference was found in the incidence of EA or moderate pain among the 3 groups during recovery.
IMPLICATIONS


The generation of HFIP would be inhibited when the inhaled sevoflurane concentration increased to 1.5 MAC. However, the incidence of EA during recovery had nothing to do with the inhaled different sevoflurane concentrations (within 1.5 MAC) in adults. ChicCTR.org identifier: ChiCTR-IPD-17011558.",2019,"No significant difference was found in the incidence of EA or moderate pain among the 3 groups during recovery.
","['Sixty adult patients planning to undergo laparoscopic gastrointestinal surgery', 'Laparoscopic Gastrointestinal Surgery']","['1.5-MAC', 'sevoflurane', 'Sevoflurane', 'sevoflurane as the volatile anesthetic at different concentrations: 0.5 minimum alveolar concentration (MAC), 1.0 MAC, and 1.5 MAC']","['Emergence Agitation', 'lowest level of free HFIP and the longest recovery time', 'free hexafluoro-isopropanol (HFIP) concentration', 'Blood concentrations of sevoflurane and free HFIP', 'incidence of EA or moderate pain', 'inhaled sevoflurane concentration', 'Venous blood samples', 'peak blood concentration of free HFIP', 'blood concentrations of sevoflurane and free HFIP', 'recovery time and the incidence of EA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal Surgical Procedure'}]","[{'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C1963547', 'cui_str': 'Volatile'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0524161', 'cui_str': 'Isopropanol measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain (finding)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",60.0,0.0871735,"No significant difference was found in the incidence of EA or moderate pain among the 3 groups during recovery.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College (University), Nanchong, Sichuan, China. Electronic address: 1017018674@qq.com.'}, {'ForeName': 'Xiao-Bo', 'Initials': 'XB', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College (University), Nanchong, Sichuan, China. Electronic address: cxb64457@163.com.'}, {'ForeName': 'Wei-Guo', 'Initials': 'WG', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College (University), Nanchong, Sichuan, China. Electronic address: 446717804@qq.com.'}, {'ForeName': 'San', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China. Electronic address: 380542247@qq.com.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Guangyuan Central Hospital, Guangyuan, Sichuan, China. Electronic address: 1076731619@qq.com.'}, {'ForeName': 'Xiao-Lin', 'Initials': 'XL', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China. Electronic address: yang_xl_yang@126.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.08.022']
2083,27383313,Very-low-calorie ketogenic diet with aminoacid supplement versus very low restricted-calorie diet for preserving muscle mass during weight loss: a pilot double-blind study.,"OBJECTIVE


Obesity plays a relevant pathophysiological role in the development of health problems, arising as result of complex interaction of genetic, nutritional and metabolic factors. We conducted a dietary intervention case-control randomized trial, to compare the effectiveness on body composition of two nutritional protocols: a very-low-carbohydrate ketogenic diet (VLCKD), integrated by an aminoacid supplement with whey protein, and very low restricted-calorie diet (VLCD).
PATIENTS AND METHODS


The clinical study was conducted with a randomized case-control in which twenty-five healthy subjects gave informed consent to participate in the interventional study and were evaluated for their health and nutritional status, by anthropometric, and body composition evaluation.
RESULTS


The results of this pilot study show that a diet low in carbohydrates, associated with a decreased caloric intake, is effective in weight loss. After VLCKD, versus VLCD, no significant differences in body lean of the trunk, body lean distribution (android and gynoid), total body lean were observed (p > 0.05). After VLCKD, no increasing of sarcopenia frequency, according ASSMI, was observed.
DISCUSSION


Many studies have shown the effectiveness of the ketogenic diet on weight loss; even if not know how to work effectively, as some researchers believe that the weight loss is due to reduced calorie intake, satiety could also be induced by the effect of the proteins, rather than the low-carbohydrates.
CONCLUSIONS


Our pilot study showed that a VLCKD was highly effective in terms of body weight reduction without to induce lean body mass loss, preventing the risk of sarcopenia. Further clinical trials are needed on a larger population and long-term body weight maintenance and risk factors management effects of VLCKD. There is no doubt, however, that a proper dietary approach would impact significantly on the reduction of public expenditure costs, in view of prospective data on increasing the percentage of obese people in our nation.",2016,"After VLCKD, versus VLCD, no significant differences in body lean of the trunk, body lean distribution (android and gynoid), total body lean were observed (p > 0.05).","['twenty-five healthy subjects gave informed consent to participate in the interventional study and were evaluated for their health and nutritional status, by anthropometric, and body composition evaluation']","['aminoacid supplement versus very low restricted-calorie diet', 'nutritional protocols: a very-low-carbohydrate ketogenic diet (VLCKD), integrated by an aminoacid supplement with whey protein, and very low restricted-calorie diet (VLCD', 'VLCKD']","['body lean of the trunk, body lean distribution (android and gynoid), total body lean', 'weight loss', 'sarcopenia frequency', 'caloric intake', 'public expenditure costs']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet (finding)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}]","[{'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0718532', 'cui_str': 'Android'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C4704716', 'cui_str': 'Public Expenditures'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",25.0,0.018378,"After VLCKD, versus VLCD, no significant differences in body lean of the trunk, body lean distribution (android and gynoid), total body lean were observed (p > 0.05).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Merra', 'Affiliation': 'Emergency Department, ""A. Gemelli"" General Hospital Foundation, Catholic University of the Sacred Heart, School of Medicine, Rome, Italy. delorenzo@uniroma2.it.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Miranda', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Barrucco', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gualtieri', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mazza', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Moriconi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marchetti', 'Affiliation': ''}, {'ForeName': 'T F M', 'Initials': 'TF', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'De Lorenzo', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Di Renzo', 'Affiliation': ''}]",European review for medical and pharmacological sciences,[]
2084,32069288,Digitally enabled aged care and neurological rehabilitation to enhance outcomes with Activity and MObility UsiNg Technology (AMOUNT) in Australia: A randomised controlled trial.,"BACKGROUND


Digitally enabled rehabilitation may lead to better outcomes but has not been tested in large pragmatic trials. We aimed to evaluate a tailored prescription of affordable digital devices in addition to usual care for people with mobility limitations admitted to aged care and neurological rehabilitation.
METHODS AND FINDINGS


We conducted a pragmatic, outcome-assessor-blinded, parallel-group randomised trial in 3 Australian hospitals in Sydney and Adelaide recruiting adults 18 to 101 years old with mobility limitations undertaking aged care and neurological inpatient rehabilitation. Both the intervention and control groups received usual multidisciplinary inpatient and post-hospital rehabilitation care as determined by the treating rehabilitation clinicians. In addition to usual care, the intervention group used devices to target mobility and physical activity problems, individually prescribed by a physiotherapist according to an intervention protocol, including virtual reality video games, activity monitors, and handheld computer devices for 6 months in hospital and at home. Co-primary outcomes were mobility (performance-based Short Physical Performance Battery [SPPB]; continuous version; range 0 to 3; higher score indicates better mobility) and upright time as a proxy measure of physical activity (proportion of the day upright measured with activPAL) at 6 months. The dataset was analysed using intention-to-treat principles. The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000936628). Between 22 September 2014 and 10 November 2016, 300 patients (mean age 74 years, SD 14; 50% female; 54% neurological condition causing activity limitation) were randomly assigned to intervention (n = 149) or control (n = 151) using a secure online database (REDCap) to achieve allocation concealment. Six-month assessments were completed by 258 participants (129 intervention, 129 control). Intervention participants received on average 12 (SD 11) supervised inpatient sessions using 4 (SD 1) different devices and 15 (SD 5) physiotherapy contacts supporting device use after hospital discharge. Changes in mobility scores were higher in the intervention group compared to the control group from baseline (SPPB [continuous, 0-3] mean [SD]: intervention group, 1.5 [0.7]; control group, 1.5 [0.8]) to 6 months (SPPB [continuous, 0-3] mean [SD]: intervention group, 2.3 [0.6]; control group, 2.1 [0.8]; mean between-group difference 0.2 points, 95% CI 0.1 to 0.3; p = 0.006). However, there was no evidence of a difference between groups for upright time at 6 months (mean [SD] proportion of the day spent upright at 6 months: intervention group, 18.2 [9.8]; control group, 18.4 [10.2]; mean between-group difference -0.2, 95% CI -2.7 to 2.3; p = 0.87). Scores were higher in the intervention group compared to the control group across most secondary mobility outcomes, but there was no evidence of a difference between groups for most other secondary outcomes including self-reported balance confidence and quality of life. No adverse events were reported in the intervention group. Thirteen participants died while in the trial (intervention group: 9; control group: 4) due to unrelated causes, and there was no evidence of a difference between groups in fall rates (unadjusted incidence rate ratio 1.19, 95% CI 0.78 to 1.83; p = 0.43). Study limitations include 15%-19% loss to follow-up at 6 months on the co-primary outcomes, as anticipated; the number of secondary outcome measures in our trial, which may increase the risk of a type I error; and potential low statistical power to demonstrate significant between-group differences on important secondary patient-reported outcomes.
CONCLUSIONS


In this study, we observed improved mobility in people with a wide range of health conditions making use of digitally enabled rehabilitation, whereas time spent upright was not impacted.
TRIAL REGISTRATION


The trial was prospectively registered with the Australian New Zealand Clinical Trials Register; ACTRN12614000936628.",2020,"Scores were higher in the intervention group compared to the control group across most secondary mobility outcomes, but there was no evidence of a difference between groups for most other secondary outcomes including self-reported balance confidence and quality of life.","['Australia', 'Between 22 September 2014 and 10 November 2016, 300 patients (mean age 74 years, SD 14; 50% female; 54% neurological condition causing activity limitation', 'people with mobility limitations admitted to aged care and neurological rehabilitation', '258 participants (129 intervention, 129 control', '3 Australian hospitals in Sydney and Adelaide recruiting adults 18 to 101 years old with mobility limitations undertaking aged care and neurological inpatient rehabilitation']","['intervention group used devices to target mobility and physical activity problems, individually prescribed by a physiotherapist according to an intervention protocol, including virtual reality video games, activity monitors, and handheld computer devices', 'secure online database (REDCap', 'average 12 (SD 11) supervised inpatient sessions using 4 (SD 1) different devices and 15 (SD 5) physiotherapy contacts supporting device use after hospital discharge', 'usual multidisciplinary inpatient and post-hospital rehabilitation care']","['self-reported balance confidence and quality of life', 'upright time', 'adverse events', 'risk of a type I error; and potential low statistical power', 'Changes in mobility scores', 'mobility (performance-based Short Physical Performance Battery [SPPB]; continuous version; range 0 to 3; higher score indicates better mobility) and upright time as a proxy measure of physical activity (proportion of the day upright measured with activPAL']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}, {'cui': 'C0204096', 'cui_str': 'Neurologic Rehabilitation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1828349', 'cui_str': 'Using device'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1136005', 'cui_str': 'Computers, Handheld'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0019728', 'cui_str': 'HLA-A'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1298904', 'cui_str': 'Device used'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0034380'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.158428,"Scores were higher in the intervention group compared to the control group across most secondary mobility outcomes, but there was no evidence of a difference between groups for most other secondary outcomes including self-reported balance confidence and quality of life.","[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hassett', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maayken', 'Initials': 'M', 'LastName': 'van den Berg', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'McCluskey', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Hidde P', 'Initials': 'HP', 'LastName': 'van der Ploeg', 'Affiliation': 'Department of Public & Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Stuart T', 'Initials': 'ST', 'LastName': 'Smith', 'Affiliation': 'School of Health and Human Sciences, Southern Cross University, Coffs Harbour, New South Wales, Australia.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Schurr', 'Affiliation': 'StrokeEd Collaboration, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Killington', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Bongers', 'Affiliation': 'Faculty of Design, Architecture and Building, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Togher', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Treacy', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Dorsch', 'Affiliation': 'StrokeEd Collaboration, Sydney, New South Wales, Australia.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Scrivener', 'Affiliation': 'StrokeEd Collaboration, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sakina', 'Initials': 'S', 'LastName': 'Chagpar', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Pinheiro', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Heritier', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003029']
2085,32416157,Effects of high and low sucrose-containing beverages on blood glucose and hypoglycemic-like symptoms.,"BACKGROUND AND AIMS


There is this intriguing but not yet well-explored suggestion that highly absorbable sucrose-sweetened drinks might exacerbate hunger by promoting temporal hypoglycemia-like responses already in non-diabetic healthy individuals. This might provide a possible additional explanatory mechanism for previous reported associations between consumption of sugar-sweetened drinks and body weight gain. The current study involves two separate and independently conducted human experiments exploring the effects of two different single-doses of sugar-sweetened beverages on temporal blood glucose nadir and possible related behavioral hypoglycemic-like symptoms in healthy participants.
METHODS


By way of two separately conducted between-subjects experiments, effects of 1) a low (29 g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80 g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2) were measured on changes in blood glucose, behavioral hypoglycemia, appetite and mood.
RESULTS


Experiment-1: The 29 g sucrose containing beverage caused a high (37%) glycemic increase and a smaller response (15%) to the milk drink, which both peaked 30 min after consumption, whereas the sweetened zero-energy drink had very little effect on blood glucose. Regardless of the different magnitude of peak glycemic responses, both the sugar and milk drinks rather equally caused blood glucose concentrations to return to normal and stable baseline values 90 min later. There were no (different) effects of the beverages on behavioral hypoglycemic-like symptoms, appetite or mood. Experiment-2: the 80 g sucrose containing beverage caused a large (72%) glycemic peak response at +30 min after consumption, whereas neither the sweetened zero-energy nor the non-sweetened colored water drink had any meaningful effect on blood glucose. After intake of the 80 g sugar beverage, blood glucose concentrations remained elevated (13%) at +120 min and returned to lower baseline values in the direction of hypoglycemia levels at +165 min. There were no (differential) effects of the beverages on behavioral hypoglycemic symptoms, appetite or mood.
CONCLUSIONS


The current findings indicate that instead of a low (29 g) sugar-containing beverage, a high (80 g) sugar-containing beverage caused blood glucose concentrations to fall below baseline values almost reaching hypoglycemia levels at the end of measurements. There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165 min after consumption. Since this might include that in particular consumption of high-glycemic index drinks could still promote symptoms in the longer run, further research is needed to explore possible hypoglycemic-like effects of high dosages of sugar-sweetened beverages across more extended/delayed time measurements.",2020,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"['healthy participants', 'Experiment-1', 'Experiment-2']","['high and low sucrose-containing beverages', 'low (29g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2', 'sugar-sweetened beverages']","['blood glucose, behavioral hypoglycemia, appetite and mood', 'behavioral hypoglycemic-like symptoms, appetite or mood', 'blood glucose', 'glycemic peak response', 'blood glucose and hypoglycemic-like symptoms', 'hypoglycemic-like behavioral symptoms including changes in appetite or mood', 'blood glucose concentrations', 'behavioral hypoglycemic symptoms, appetite or mood', 'temporal blood glucose nadir']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C3179078', 'cui_str': 'Energy drink'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0426587', 'cui_str': 'Altered appetite'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}]",,0.0416675,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"[{'ForeName': 'C Rob', 'Initials': 'CR', 'LastName': 'Markus', 'Affiliation': 'University Maastricht, Faculty of Psychology and Neuroscience; Dept of Neuropsychology & Psychopharmacology, Maastricht, Netherlands.. Electronic address: r.markus@maastrichtuniversity.nl.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'Nutrition and Behaviour Unit, School of Psychological Science, University of Bristol, Bristol, UK.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112916']
2086,31562412,Preventing white spot lesions with fluoride pastes.,"Design Randomised controlled trial.Study population Patients undergoing routine orthodontic treatment, aged 12 years and older, were randomly allocated to use either Clinpro 5000, Clinpro Tooth Crème or MI Paste Plus for 4 months.Data Analysis Three-way analysis of variance (ANOVA) was used to analyse the Enamel Decalcification Index (EDI) scores of the maxillary and mandibular arches from the right first premolar to the left first premolar at 0.05 level of significance. Fisher-protected least significant difference intervals were used to compare mean EDI scores. Two operators scored photographs independently and their scores were compared by using the t-test; no statistically significant difference (P ≥.05) was found between the operators. Results of each product were analysed individually and amongst themselves. A multilevel mixed-effects Poisson regression was used to model factors predictive of EDI scores for individual teeth.Results Of the 120 subjects enrolled, 100 (35 using Clinpro 5000, 32 using Clinpro Tooth Crème, and 33 using MI Paste Plus) completed the study. The data lends support for Clinpro 5000 providing superior protection against enamel decalcification when compared to Clinpro Crème, and mixed support when compared to MI Paste Plus.Conclusions The use of Clinpro 5000, Clinpro Tooth Crème, and MI Paste Plus all have a reduction effect on white spot lesions when compared to studies reported previously. They found Clinpro 5000 to have a marginally better effect than the two other test pastes.",2019,Two operators scored photographs independently and their scores were compared by using the t-test; no statistically significant difference (P ≥.05) was found between the operators.,"['120 subjects enrolled, 100 (35 using Clinpro 5000, 32 using Clinpro Tooth Crème, and 33 using MI Paste', 'Study population Patients undergoing routine orthodontic treatment, aged 12 years and older']","['MI Paste', 'Clinpro 5000, Clinpro Tooth Crème, and MI Paste', 'Clinpro 5000, Clinpro Tooth Crème or MI Paste Plus for 4 months']","['mean EDI scores', 'white spot lesions', 'Enamel Decalcification Index (EDI) scores of the maxillary and mandibular arches']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2927681', 'cui_str': 'Clinpro 5000'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C2927681', 'cui_str': 'Clinpro 5000'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spot'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0700185', 'cui_str': 'Demineralized structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231063', 'cui_str': 'First branchial arch structure'}]",120.0,0.0309652,Two operators scored photographs independently and their scores were compared by using the t-test; no statistically significant difference (P ≥.05) was found between the operators.,"[{'ForeName': 'Robert S D', 'Initials': 'RSD', 'LastName': 'Smyth', 'Affiliation': 'Eastman Dental Hospital, London, UK.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Noar', 'Affiliation': 'Eastman Dental Hospital, London, UK.'}]",Evidence-based dentistry,['10.1038/s41432-019-0041-6']
2087,31227681,Wide-detector CT combined iterative reconstruction in pediatric low-dose scan of the paranasal sinus.,"BACKGROUND


Computed tomography (CT) is considered a standard modality for imaging the paranasal sinus (PS), but increasingly radiation dose is of concern, especially in children.
OBJECTIVE


This study aims to investigate the feasibility of using a 320-detector CT scanner with a 16 cm wide-detector combined with iterative reconstruction (IR) algorithm to further reduce radiation dose when scanning the PS.
METHODS


A total of 90 children who underwent CT of the PS were randomly allocated into three groups namely, (1) the experimental group using low-dose wide-detector scan (n = 30, 9±4 years); (2) low-dose helical group (n = 30, 9±4 years); and (3) pediatric conventional group (n = 30, 8±4 years). Statistical software SPSS 19.0 was used for one-way ANOVA analysis of the general data (age, BMI), image quality, and radiation dose. Multiple comparisons of data without homogeneity of variance were analyzed by Bonferroni test and Tamhane's test.
RESULTS


All patients underwent successful CT examinations. No significant differences in the general data and image quality evaluation were detected between three groups (all P values > 0.05). CTDIvol and DLP were 2.87 mGy and 32.58 mGy·cm in the experimental group, 4.92 mGy and 70.84 mGy·cm in the low-dose helical group, and 9.95 mGy and 131.83 mGy·cm in the conventional group, respectively, which were significantly different among these three groups as indicated by multiple comparisons (all P values < 0.05). In the experimental group, the effective radiation dose was 0.07 mSv, which was reduced by 76% and 56% comparing to the conventional group and the low-dose helical group, respectively.
CONCLUSIONS


The 320-detector CT scanner equipped with the wide-detector combined with IR can further reduce radiation dose, while maintaining good image quality comparing to the low-dose helical or pediatric modes.",2019,No significant differences in the general data and image quality evaluation were detected between three groups (all P values > 0.05).,['A total of 90 children who underwent CT of the PS'],"['Wide-detector CT combined iterative reconstruction', '320-detector CT scanner with a 16 cm wide-detector combined with iterative reconstruction (IR) algorithm', 'experimental group using low-dose wide-detector scan', 'Computed tomography (CT']","['general data and image quality evaluation', 'CTDIvol and DLP']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0002045'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0441633'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",90.0,0.0243493,No significant differences in the general data and image quality evaluation were detected between three groups (all P values > 0.05).,"[{'ForeName': 'Que', 'Initials': 'Q', 'LastName': 'Kong', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi Second Hospital, Wuxi, China.'}, {'ForeName': 'Fengqi', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi Second Hospital, Wuxi, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi Second Hospital, Wuxi, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Qiao', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi Second Hospital, Wuxi, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Shao', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi Second Hospital, Wuxi, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xie', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi Second Hospital, Wuxi, China.'}]",Journal of X-ray science and technology,['10.3233/XST-180487']
2088,27189038,The effect of daily zinc and/or multivitamin supplements on early childhood development in Tanzania: results from a randomized controlled trial.,"Impaired childhood development has lifelong consequences for educational attainment and wage-earning potential. Micronutrient supplements have the potential to improve development. The objective of this study was to determine the effect of daily zinc and/or multivitamin (vitamins C, E and B-complex) supplements on development among Tanzanian infants. In this randomized, 2 × 2 factorial, double-blind trial, 2400 infants were randomized to zinc (Zn), multivitamins (MV), zinc and multivitamins (Zn + MV) or placebo at 6 weeks of age. At approximately 15 months, a sub-sample of 247 children underwent developmental assessment using the cognitive, language (receptive and expressive) and motor (fine and gross) scales of the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III). Mean BSID-III scores were compared using univariate and multivariate linear regression models adjusted for child's sex, post-conceptual age and test administrator. Logistic regressions were used to assess odds of low developmental scores. We did not detect a significant difference in mean BSID-III scores in any of the five domains in univariate or multivariate models comparing each of the four treatment groups. We also did not detect a significant difference in mean BSID-III scores when comparing children who received zinc supplements versus those who did not, or in comparisons of children who received multivitamin supplements versus those who did not. There was no significant difference in odds of a low BSID-III score in any of the five domains in treatment arms either. Because neither daily zinc nor multivitamin (vitamins B-complex, C and E) supplementation led to improvements in any of the developmental domains assessed using the BSID-III, we recommend pursuing alternative interventions to promote early childhood development in vulnerable populations. © 2016 John Wiley & Sons Ltd.",2017,There was no significant difference in odds of a low BSID-III score in any of the five domains in treatment arms either.,"['early childhood development in Tanzania', '2400 infants were randomized to', 'Tanzanian infants']","['zinc (Zn), multivitamins (MV), zinc and multivitamins (Zn\u2009+\u2009MV) or placebo', 'zinc supplements', 'daily zinc and/or multivitamin (vitamins C, E and B-complex) supplements', 'daily zinc and/or multivitamin supplements', 'Micronutrient supplements', 'multivitamin supplements', 'daily zinc nor multivitamin (vitamins B-complex, C and E) supplementation']","['Mean BSID-III scores', 'low BSID-III score', 'cognitive, language (receptive and expressive) and motor (fine and gross) scales of the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III', 'mean BSID-III scores']","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0441796', 'cui_str': 'Third edition (qualifier value)'}]",2400.0,0.325899,There was no significant difference in odds of a low BSID-III score in any of the five domains in treatment arms either.,"[{'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Locks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Karim P', 'Initials': 'KP', 'LastName': 'Manji', 'Affiliation': 'Department of Pediatrics, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'McDonald', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Kupka', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Rodrick', 'Initials': 'R', 'LastName': 'Kisenge', 'Affiliation': 'Department of Pediatrics, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Molin', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Bellinger', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Wafaie W', 'Initials': 'WW', 'LastName': 'Fawzi', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12306']
2089,32416385,Transdiagnostic preventative intervention for subclinical anxiety: Development and initial validation.,"Risk factors associated with the development of anxiety disorders have been identified; however, the development of preventive interventions targeting these risk factors is in the nascent stage. To date, preventive interventions have tended to target specific anxiety disorder symptoms (e.g., panic attacks). Although these interventions are effective at reducing risk for the targeted disorder (e.g., panic disorder), the focus of the intervention is narrow, thereby limiting the dissemination of these interventions. One approach that may broaden the scope of our prevention efforts is the development of a transdiagnostic intervention. Currently, transdiagnostic interventions have only been used in those with diagnosed conditions (e.g., anxiety disorders); however, it stands to reason that a transdiagnostic approach may also be helpful for those at-risk for developing anxiety disorders. The present study reported on the development and use of a brief preventative intervention for those with subclinical anxiety (i.e., worry, social anxiety). Participants were randomized into either a transdiagnostic preventative intervention, focused on reduction of safety aids, or a health focused control group. Participants consisted of sixty-nine individuals with subclinical levels of anxiety. Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group. Further, change in safety aid utilization was a significant mediator in the association between intervention group and social anxiety and worry at Week 1; however, it was not a significant mediator at Month 1. Implications of these results and avenues for future research are discussed.",2020,"Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group.",['Participants consisted of sixty-nine individuals with subclinical levels of anxiety'],"['transdiagnostic preventative intervention, focused on reduction of safety aids, or a health focused control group', 'Transdiagnostic preventative intervention']","['safety aid utilization', 'social anxiety, worry, and levels of impairment', 'social anxiety and worry']","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",69.0,0.0158088,"Results revealed significant between group differences in the reduction of social anxiety, worry, and levels of impairment with the active intervention group relative to the control group.","[{'ForeName': 'Kristina J', 'Initials': 'KJ', 'LastName': 'Korte', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA; Harvard T.H. Chan School of Public Health, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: kkorte@mgh.harvard.edu.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Florida State University, Tallahassee, FL, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.04.001']
2090,31563433,Recovery of left ventricular dysfunction after sacubitril/valsartan: predictors and management.,"BACKGROUND


Literature describing recovery of left ventricular (LV) function post sacubitril/valsartan treatment and the optimal management of heart failure (HF) patients receiving sacubitril/valsartan remain sparse.
METHODS


We recruited 437 consecutive chronic HF patients with baseline left ventricular ejection fraction (LVEF) less than 40%, who were treated with sacubitril/valsartan. All patients underwent routine echocardiographic measurement.
RESULTS


During treatment period, recovery of LVEF to 50% or greater was observed in 77 (17.6%) patients. After multivariate analysis, recovery of LV dysfunction was associated with non-ischemic etiology of HF, smaller baseline LV end-diastolic diameter (LVEDD), and higher initial dosage of sacubitril/valsartan. Compared to those without recovery of LV dysfunction, death from cardiovascular causes or first unplanned hospitalization for HF (CVD/HFH) were significantly lower in patients with LVEF recovery [11.7% vs. 24.4%, hazard ratio (HR) 0.42, p = 0.014]. Among patients with recovery of LVEF, 51 patients continued to receive the same dosage of sacubitril/valsartan had higher LVEF and were less likely to have deterioration of LVEF than the other 26 patients who received either tapering dose of sacubitril/valsartan or switching from sacubitril/valsartan to renin-angiotensin-system blockers (LVEF 56.4 ± 5.3% vs. 45.0 ± 12.8%, p < 0.001; ΔLVEF 1.2 ± 5.1% vs. -9.3 ± 12.0%, p < 0.001). CVD/HFH occurred more frequently in the taper group than the maintenance group (23.1% vs. 5.9%, HR 0.22, p = 0.035).
CONCLUSIONS


Non-ischemic etiology of HF, smaller baseline LVEDD, and higher initial dosage of sacubitril/valsartan could predict better recovery of LV function. Among patients with functional recovery, tapering sacubitril/valsartan dose was associated with deterioration of recovered heart function and had less favorable prognosis during follow-up.",2020,"Compared to those without recovery of LV dysfunction, death from cardiovascular causes or first unplanned hospitalization for HF (CVD/HFH) were significantly lower in patients with LVEF recovery [11.7% vs. 24.4%, hazard ratio (HR)","['437 consecutive chronic HF patients with baseline left ventricular ejection fraction (LVEF) less than 40%, who were treated with', 'heart failure (HF) patients receiving sacubitril/valsartan remain sparse']",['sacubitril/valsartan'],"['LV dysfunction, death from cardiovascular causes or first unplanned hospitalization for HF (CVD/HFH', 'recovery of LVEF', 'Recovery of left ventricular dysfunction', 'CVD/HFH', 'recovery of LV dysfunction', 'non-ischemic etiology of HF, smaller baseline LV end-diastolic diameter (LVEDD', 'deterioration of LVEF', 'deterioration of recovered heart function', 'hazard ratio (HR']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}]","[{'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}]","[{'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0242973', 'cui_str': 'Ventricular Dysfunction'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C4521692', 'cui_str': 'Cardiac physiological function (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",437.0,0.0425829,"Compared to those without recovery of LV dysfunction, death from cardiovascular causes or first unplanned hospitalization for HF (CVD/HFH) were significantly lower in patients with LVEF recovery [11.7% vs. 24.4%, hazard ratio (HR)","[{'ForeName': 'Hung-Yu', 'Initials': 'HY', 'LastName': 'Chang', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Kuan-Chun', 'Initials': 'KC', 'LastName': 'Chen', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan; National Defense Medical Center, Taipei, Taiwan; Institute of Emergency and Critical Care Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Man-Cai', 'Initials': 'MC', 'LastName': 'Fong', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan; National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'An-Ning', 'Initials': 'AN', 'LastName': 'Feng', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hao-Neng', 'Initials': 'HN', 'LastName': 'Fu', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kuan-Chih', 'Initials': 'KC', 'LastName': 'Huang', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Chong', 'Affiliation': 'Division of Cardiology, Farrer Park Hospital, Singapore.'}, {'ForeName': 'Wei-Hsian', 'Initials': 'WH', 'LastName': 'Yin', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan. Electronic address: adr@chgh.org.tw.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.08.005']
2091,31564512,Effects of Celecoxib on the QTc Interval: A Thorough QT/QTc Study.,"PURPOSE


Celecoxib is a selective cyclooxygenase-2 inhibitor widely used in patients with osteoarthritis and rheumatoid arthritis. Recently, nonclinical data on the inhibition of human ether-à-go-go-related gene potassium channels by celecoxib were reported, but there is no compelling evidence for this finding in humans. The aim of this study was to assess the potential effects of celecoxib on cardiac repolarization by conducting a thorough QT study, which was designed in compliance with the related guidelines.
METHODS


This randomized, open-label, positive- and negative-controlled, crossover clinical study was conducted in healthy male and female subjects. Each subject received, in 1 of 4 randomly assigned sequences, all of the following 3 interventions: celecoxib 400 mg once daily for 6 days; a single dose of moxifloxacin 400 mg, which served as a positive control to assess the assay sensitivity; and water without any drug, which served as a negative control. Serial 12-lead ECG and blood samples for pharmacokinetic analysis were collected periodically over 24 h. Individually RR-corrected QT intervals (QTcI) and Fridericia method-corrected QT intervals (QTcF) were calculated and evaluated.
FINDINGS


Twenty-eight subjects were allocated to 1 of the 4 intervention sequences. The largest time-matched mean effects of celecoxib on the QTcI and QTcF were <5 ms, and the upper bounds of the 1-sided 95% CIs of those values did not exceed 10 ms. Moreover, none of the subjects had an absolute QTcI value of >450 ms or a change from baseline in QTcI of >60 ms after multiple administrations of celecoxib. The QTcI did not show a positive correlation with celecoxib concentrations in the range up to ~2700 μg/L. The overall effects of moxifloxacin on the QTcI and QTcF were enough to establish assay sensitivity. No serious adverse events were reported, with a total of 11 AEs reported in 8 subjects.
IMPLICATIONS


Celecoxib caused no clinically relevant increase in the QT/QTc interval at the maximum dose level used in current practice settings. ClinicalTrials.gov identifier: NCT03822520.",2019,The QTcI did not show a positive correlation with celecoxib concentrations in the range up to ~2700 μg/,"['Twenty-eight subjects', 'healthy male and female subjects', 'patients with osteoarthritis and rheumatoid arthritis']","['Celecoxib', 'moxifloxacin', 'celecoxib', '41:XXX-XXX', 'celecoxib 400\xa0mg once daily for 6 days; a single dose of moxifloxacin 400\xa0mg, which served as a positive control to assess the assay sensitivity; and water without any drug, which served as a negative control']","['QT/QTc interval', 'cardiac repolarization', 'Individually RR-corrected QT intervals (QTcI) and Fridericia', 'absolute QTcI value', 'method-corrected QT intervals (QTcF', 'QTcI and QTcF', 'serious adverse events', 'QTc Interval']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1166422', 'cui_str': 'celecoxib 400 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1592286', 'cui_str': 'moxifloxacin 400 MG [Avelox]'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",28.0,0.0782001,The QTcI did not show a positive correlation with celecoxib concentrations in the range up to ~2700 μg/,"[{'ForeName': 'Seokuee', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeryeon', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Wook', 'Initials': 'JW', 'LastName': 'Ko', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Ryul', 'Initials': 'JR', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea; Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, Republic of Korea. Electronic address: jungryul.kim@gmail.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.09.004']
2092,31564513,"Pharmacokinetic Interaction Among Telmisartan, Amlodipine, and Hydrochlorothiazide After a Single Oral Administration in Healthy Male Subjects.","PURPOSE


Hypertension is a major risk factor for cardiovascular diseases, necessitating hypertension control. Antihypertensive drugs are more potent when administered in combinations of 2 or 3 different classes of drugs. One such therapy includes a combination of an angiotensin receptor blocker, a calcium channel blocker, and a diuretic. The objective of this study was to evaluate the pharmacokinetic interaction among telmisartan, amlodipine, and hydrochlorothiazide.
METHODS


A randomized, open-label, 3-period, 6-sequence, 3-treatment, single-dose crossover study was conducted in healthy male subjects. Subjects were randomly assigned to 1 of 6 sequences and one of the following treatments was administered in each period: treatment A, co-administration of one tablet of telmisartan 80 mg and one tablet of amlodipine 10 mg; treatment B, one tablet of hydrochlorothiazide 25 mg alone; and treatment C, co-administration of all 3 investigational products. Serial blood samples were collected up to 144 hours postdose. Plasma drug concentrations were measured by using LC/MS-MS. Pharmacokinetic parameters, including C max  and AUC 0-last , were determined by using noncompartmental analysis. The geometric least squares mean ratios and associated 90% CIs of log-transformed C max  and AUC 0-last  for separate administration or co-administration were calculated to evaluate pharmacokinetic interactions.
FINDINGS


Twenty-seven subjects completed the study. The geometric least squares mean ratios and 90% CIs of C max  and AUC 0-last  were 1.02 (0.85-1.21) and 1.04 (0.97-1.13) for telmisartan; 1.00 (0.95-1.04) and 0.95 (0.91-0.99) for amlodipine; and 0.88 (0.82-0.96) and 0.86 (0.82-0.90) for hydrochlorothiazide, respectively. No serious adverse events were recorded, and all reported adverse events were of mild intensity.
IMPLICATIONS


The pharmacokinetic parameters of telmisartan, amlodipine, and hydrochlorothiazide when administered separately or co-administered were compared, and all the parameters met the criteria for pharmacokinetic equivalence. Combination therapy of these 3 drugs had no significant impact on the pharmacokinetic parameters of each drug. (ClinicalTrials.gov Identifier: NCT03889145).",2019,"No serious adverse events were recorded, and all reported adverse events were of mild intensity.
","['Twenty-seven subjects completed the study', 'Healthy Male Subjects', 'healthy male subjects']","['telmisartan, amlodipine, and hydrochlorothiazide', 'amlodipine', 'telmisartan 80\xa0mg and one tablet of amlodipine 10\xa0mg; treatment B, one tablet of hydrochlorothiazide 25\xa0mg alone; and treatment C, co-administration of all 3 investigational products', 'hydrochlorothiazide', 'Telmisartan, Amlodipine, and Hydrochlorothiazide']","['Serial blood samples', 'Pharmacokinetic parameters, including C max  and AUC 0-last', 'Plasma drug concentrations', 'pharmacokinetic interaction', 'pharmacokinetic parameters', 'serious adverse events']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C1607513', 'cui_str': 'telmisartan 80 MG [Micardis]'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1124794', 'cui_str': 'Amlodipine 10 MG'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0986526', 'cui_str': 'Hydrochlorothiazide 25 MG'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1868980', 'cui_str': 'Pharmacokinetic interaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",27.0,0.0236295,"No serious adverse events were recorded, and all reported adverse events were of mild intensity.
","[{'ForeName': 'Seol Ju', 'Initials': 'SJ', 'LastName': 'Moon', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea; Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Min-Gul', 'Initials': 'MG', 'LastName': 'Kim', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea; Research Institute of Clinical Medicine of Chonbuk National University, Jeonju, Republic of Korea; Department of Pharmacology, School of Medicine, Chonbuk National University, Jeonju, Republic of Korea. Electronic address: mgkim@jbnu.ac.kr.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.08.020']
2093,31566604,Investigating the Effect of Visual Imagery and Learning Shape-Audio Regularities on Bouba and Kiki.,"This article presents a protocol for investigating the role of visual imagery in the bouba/kiki-effect, whether training in noticing the bouba/kiki shape-audio regularities affects the bouba/kiki-effect and the recognition of individual bouba and kiki shapes, and finally what mental images these regularities produce. To generate bouba/kiki shape-audio regularities, there were two types of shapes (filled; outlined) and two types of audio (word; non-word sound). Three groups of individuals participated in three experiments: Blind, blindfold, and vision. The experiments were conducted in fixed order across participants, with no break between them. In Experiment 1 (pre-test-post-test design with three repeated within-group measures) the participants were asked to pick out the shape they associated with the auditory bouba/kiki; in Experiment 2 (within-subject design), to name one shape and some audio (sometimes congruous; sometimes incongruous) as 'bouba' or 'kiki;' and in Experiment 3 (post-test only design), to draw the shape they associated with the auditory bouba/kiki. The results suggest that the blindfold-group draw upon visual imagery to solve new problems, but not long term; that training in noticing bouba/kiki shape-audio regularities affects the bouba/kiki-effect and the recognition of individual bouba and kiki shapes, but differently in each experimental group; and that all experimental groups create mental images of the most characteristic shape feature of bouba (curve) and kiki (angle). In fact, the effect of visual imagery is robust across tasks, but not long term; the effect of learning shape-audio regularities is robust long term, but not across tasks. The presented protocol is appropriate for investigating the effect of visual imagery and learning shape-audio regularities, when they occur and how robust they are; in specific individuals and groups of individuals. This protocol is unique in that it keeps under control both the visual imagery and the sensory information during training and testing.",2019,"The results suggest that the blindfold-group draw upon visual imagery to solve new problems, but not long term; that training in noticing bouba/kiki shape-audio regularities affects the bouba/kiki-effect and the recognition of individual bouba and kiki shapes, but differently in each experimental group; and that all experimental groups create mental images of the most characteristic shape feature of bouba (curve) and kiki (angle).",[],['Visual Imagery and Learning Shape-Audio Regularities'],[],[],"[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0449581', 'cui_str': 'Regularity (attribute)'}]",[],,0.0284172,"The results suggest that the blindfold-group draw upon visual imagery to solve new problems, but not long term; that training in noticing bouba/kiki shape-audio regularities affects the bouba/kiki-effect and the recognition of individual bouba and kiki shapes, but differently in each experimental group; and that all experimental groups create mental images of the most characteristic shape feature of bouba (curve) and kiki (angle).","[{'ForeName': 'Torø', 'Initials': 'T', 'LastName': 'Graven', 'Affiliation': 'Department of Experimental Psychology, University of Oxford; toro.graven@humanities.ox.ac.uk.'}, {'ForeName': 'Clea', 'Initials': 'C', 'LastName': 'Desebrock', 'Affiliation': 'Department of Experimental Psychology, University of Oxford.'}]",Journal of visualized experiments : JoVE,['10.3791/59954']
2094,32415923,Effect of calcitriol combined with sevelamer carbonate on serum parathyroid hormone in patients with chronic renal failure.,"This study aimed to observe and analyze the effect of calcitriol combined with sevelamer carbonate on serum parathyroid hormone in patients with chronic renal failure. This study included 180 patients who had been treated for chronic renal failure in our hospital were enrolled as research objects. The patients were randomly divided into two groups: a research group and a control group, each containing 90 cases. The research group was treated with calcitriol combined with sevelamer carbonate, and the control group was treated with calcitriol alone. The therapeutic effects of the two groups were observed and analyzed by SPSS 21. Comparing the levels of blood indexes (Ca, Cr, P, ALP, iPTH, TC, TG, LDL-C, HDL-C) of the two groups showed no significant difference between the two groups, P &lt;0.05. Our results have the effect of different treatment regimens, the improvement effect of various blood indicators in the research group was significantly better than the control group, p&lt;0.05.  We concluded that the combined therapy of calcitriol and sevelamer carbonate in chronic renal failure patients can significantly improve the therapeutic effect, and at the same time actively improve the serum parathyroid hormone level, which is a treatment model that can be popularized and applied.",2020,"Comparing the levels of blood indexes (Ca, Cr, P, ALP, iPTH, TC, TG, LDL-C, HDL-C) of the two groups showed no significant difference between the two groups, P &lt;0.05.","['chronic renal failure patients', '180 patients who had been treated for chronic renal failure in our hospital were enrolled as research objects', 'patients with chronic renal failure']","['calcitriol and sevelamer carbonate', 'calcitriol alone', 'calcitriol combined with sevelamer carbonate', 'calcitriol combined with sevelamer\xa0carbonate']","['serum parathyroid hormone level', 'therapeutic effects', 'levels of blood indexes (Ca, Cr, P, ALP, iPTH, TC, TG, LDL-C, HDL-C', 'serum parathyroid hormone']","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]","[{'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C1721288', 'cui_str': 'Sevelamer carbonate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0047008', 'cui_str': ""3,4-O-isopropylidene-3,3',4,5'-tetrahydroxystilbene""}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",180.0,0.0114577,"Comparing the levels of blood indexes (Ca, Cr, P, ALP, iPTH, TC, TG, LDL-C, HDL-C) of the two groups showed no significant difference between the two groups, P &lt;0.05.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Nephrology Department, Tangshan Gongren Hospital, Tangshan, 063000, China.'}, {'ForeName': 'Zhinan', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Nephrology Department, Tangshan Gongren Hospital, Tangshan, 063000, China.'}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2095,32415945,Efficacy of cefotaxime combined with gamma globulins on C-reactive protein and procalcitonin in neonatal sepsis.,"C-reactive protein (CRP) is encoded by CRP or PTX1 gene and procalcitonin (PCT) is produced by the CALC-1 gene induction. Both PCT and CRP are known as valued biomarkers markers in prediction of Serious Bacterial Infections (SBI) in children. This experiment carried out to analyze the efficacy of cefotaxime combined with gamma globulins on neonatal sepsis and the effect on CRP and PCT. For this purpose, a total of 120 sepsis children were selected and randomly divided into observation and control groups. Children in the control group were treated with cefotaxime, while children in the observation group were treated with cefotaxime combined with gamma globulins. The two groups were compared in terms of the relative measures of efficacy, the total effective rate of treatment, the incidence of complications and serum CRP and PCT levels before and after treatment. The clinical measures of the observation group were all lower than those of the control group, and the total effective rate of the treatment was higher than that of the control group, while the incidence of complications was lower than that of the control group. In addition, before treatment, there was no difference in CRP and PCT between the two groups; after treatment, the above measures in the observation group were lower than those in the control group. It is concluded that Cefotaxime combined with gamma globulins in the treatment of neonatal sepsis has significant efficacy and is clinically more effective than cefotaxime monotherapy. This combination can shorten clinical symptom remission time and hospital stay, improve serum CRP and PCT levels and promote the recovery of children, worthy of promotion.",2020,"This combination can shorten clinical symptom remission time and hospital stay, improve serum CRP and PCT levels and promote the recovery of children, worthy of promotion.","['neonatal sepsis', '120 sepsis children']","['cefotaxime', 'cefotaxime combined with gamma globulins', 'C-reactive protein (CRP', 'Cefotaxime']","['total effective rate of treatment, the incidence of complications and serum CRP and PCT levels', 'total effective rate', 'clinical symptom remission time and hospital stay, improve serum CRP and PCT levels', 'neonatal sepsis', 'incidence of complications', 'CRP and PCT']","[{'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0007554', 'cui_str': 'Cefotaxime'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0017007', 'cui_str': 'Gamma globulin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}]",120.0,0.0137262,"This combination can shorten clinical symptom remission time and hospital stay, improve serum CRP and PCT levels and promote the recovery of children, worthy of promotion.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, The General Hospital of PLA Central Theater Command KanKou Are, Wuhan, Hubei 430014, China.'}]","Cellular and molecular biology (Noisy-le-Grand, France)",[]
2096,32416432,Effects of an exercise intervention for patients with advanced inoperable lung cancer undergoing chemotherapy: A randomized clinical trial.,"OBJECTIVE


Exercise can improve treatment-related side effects, quality of life, and function in patients with various types of cancer; however, more evidence is needed for patients with advanced inoperable lung cancer.
MATERIAL AND METHODS


We randomized 218 patients with advanced inoperable lung cancer to a 12-week supervised, structured exercise training program (aerobic, strength, and relaxation training) twice weekly versus usual care. Primary outcome was change in maximal oxygen uptake (VO 2  peak). Secondary outcomes were muscle strength, functional capacity, forced expiratory volume in 1 s, health-related quality of life, anxiety, and depression.
RESULTS


There was no significant difference between the intervention and control groups in VO 2  peak. There was a significant improvement in muscle strength. There was also a significant difference between the two for social well-being (Functional Assessment of Cancer Therapy-Lung, FACT-L), anxiety, and depression.
CONCLUSION


There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care. There was a significant difference between the groups for social well-being. The primary outcome did not show a significant improvement in VO 2  peak. Based on our results, future patients with advanced inoperable lung cancer should be considered for supervised exercise during the course of their disease.",2020,There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care.,"['patients with various types of cancer', 'patients with advanced inoperable lung cancer', '218 patients with advanced inoperable lung cancer', 'patients with advanced inoperable lung cancer undergoing']","['chemotherapy', 'exercise intervention', 'structured exercise training program (aerobic, strength, and relaxation training) twice weekly versus usual care']","['muscle strength outcomes', 'social well-being (Functional Assessment of Cancer Therapy-Lung, FACT-L), anxiety, and depression', 'VO 2  peak', 'level of anxiety and depression', 'maximal oxygen uptake (VO 2  peak', 'muscle strength', 'muscle strength, functional capacity, forced expiratory volume in 1\u2009s, health-related quality of life, anxiety, and depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C4517647', 'cui_str': '218'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",218.0,0.0758603,There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care.,"[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Quist', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark. Electronic address: morten.quist@regionh.dk.'}, {'ForeName': 'Seppo W', 'Initials': 'SW', 'LastName': 'Langer', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lillelund', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark.'}, {'ForeName': 'Lærke', 'Initials': 'L', 'LastName': 'Winther', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark.'}, {'ForeName': 'Jørgen H', 'Initials': 'JH', 'LastName': 'Laursen', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Rørth', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Adamsen', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark; Department of Public Health, University of Copenhagen, Denmark.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.003']
2097,32415824,Effectiveness of yogic visual concentration (Trataka) on cognitive performance and anxiety among adolescents.,"Background Cognition is the mental process of acquiring knowledge, understanding senses and synchronizing all the electrical activity that is constantly received and generated through the eye. Purpose of the present study was to assess the effectiveness of yogic visual concentration (Trataka) on cognitive performance and anxiety among adolescents studying in selected schools at Chennai. Methodology This study was designed to assess cognitive performance and anxiety among students using quantitative approach. True Experimental study design was used for this study. Pretest assessment of cognitive performance and anxiety was done by standardized tools (Stroop color word test, Hamilton anxiety scale) for Experimental and Control groups. Intervention of yogic visual concentration (Trataka) was experimented in one group. Control group were kept on routine activities. Post test assessment of cognitive performance and anxiety by standardized tools was performed on experimental and control groups. The data were analyzed by descriptive statistics and inferential statistics. The 0.05 level of significance was used. Results A significant difference in the mean difference of color word score, color score, word score and inference score between the study and control groups at the level of p<0.0001 was observed. Results indicate an association in the cognitive performance (word) with background variables such as, gender, father's occupation in the study group during the post test and no association in the control group. There were no associations between anxiety cognitive performance (color and word) and demographic variables in both groups. Conclusion The study concluded that there is a greater effect on Yogic visual concentration (Trataka) on cognitive performance and anxiety among adolescent students, therefore the study proved the hypothesis.",2020,"The study concluded that there is a greater effect on Yogic visual concentration (Trataka) on cognitive performance and anxiety among adolescent students, therefore the study proved the hypothesis.","['adolescents studying in selected schools at Chennai', 'students using quantitative approach', 'adolescents', 'adolescent students']",['yogic visual concentration (Trataka'],"['standardized tools (Stroop color word test, Hamilton anxiety scale', 'anxiety cognitive performance (color and word) and demographic variables', 'yogic visual concentration (Trataka', 'cognitive performance (word', 'Yogic visual concentration (Trataka) on cognitive performance and anxiety', 'mean difference of color word score, color score, word score and inference score', 'cognitive performance and anxiety']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0582675', 'cui_str': 'Stroop neuropsychological screening test'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0238278,"The study concluded that there is a greater effect on Yogic visual concentration (Trataka) on cognitive performance and anxiety among adolescent students, therefore the study proved the hypothesis.","[{'ForeName': 'J Ida', 'Initials': 'JI', 'LastName': 'Sherlee', 'Affiliation': 'Sri Ramachandra Medical College and Research Institute, Chennai, Tamil Nadu 600116, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'David', 'Affiliation': 'Sri Ramachandra Medical College and Research Institute, Chennai, Tamil Nadu 600116, India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0055']
2098,31562405,Should five to eleven-year-olds use manual or electric toothbrushes to clean their teeth?,"Design A cohort study design was used. 120 healthy children were randomly assigned to a manual group and an electric tooth brushing group. Plaque scores plus a post-brushing questionnaire examining executive function/motor skills using indices from the occupational and developmental sciences (e.g. shoelace tying), was completed by the parents .Sample selection 120 subjects were recruited from a single site, the Nationwide Children's Hospital in Columbus, Ohio. The entire research project was carried out in the dental department there.All children were fit and healthy and presented with:• No caries• No disability that would affect the task completion• No injury to the dominant hand• Adequate parental literacy to complete a questionnaire• Teeth present to score.All ages were evenly represented in the final sample.Data analysis Two hygienists and one dentist were calibrated and trained in the use of the OHI-S plaque scoring system. Reliability was determined using the Cohen's kappa. Teeth were disclosed and pre-brushing plaque scores were obtained. A set of brief brushing instructions were delivered orally to the patient. The children were given a brush and were asked to brush at a sink with no toothpaste or mirror. The minimum brushing time was 30 seconds but the children were unaware that they were being timed. Post- brushing plaque scores were measured.Results The response rate to the questionnaire was 100%. A chi-square test was carried out on the data. The results showed that if a child can exhibit the following skills/characteristics they were more likely to perform well in the brushing task• Never has poor handwriting• Always writes their address• Always ties their own shoes• Always cuts food into bite-sized pieces• Can cut out complex shapes.There was a positive correlation between pre-brushing scores and post-brushing scores .Conclusions Good handwriting and other motor/cognitive skills were linked to good tooth brushing and manual and electric toothbrushing were equally effective at removing plaque. If a child was able to play a musical instrument well, they were likely to have less plaque. The study also demonstrated that parents are good judges of their children's abilities and motor skills.",2019,Good handwriting and other motor/cognitive skills were linked to good tooth brushing and manual and electric toothbrushing were equally effective at removing plaque.,"[""selection 120 subjects were recruited from a single site, the Nationwide Children's Hospital in Columbus, Ohio"", 'All children were fit and healthy and presented with:•', '120 healthy children']",['electric tooth brushing group'],"['Post- brushing plaque scores', 'Good handwriting and other motor/cognitive skills', 'response rate', 'Reliability', 'minimum brushing time', 'task completion•']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}]","[{'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",120.0,0.0126168,Good handwriting and other motor/cognitive skills were linked to good tooth brushing and manual and electric toothbrushing were equally effective at removing plaque.,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Gallie', 'Affiliation': 'Bupa Dental Care, Stamford, Lincs.; CDS- CIC, Leicester; Immediate Past President BADT; KCL London, London, UK.'}]",Evidence-based dentistry,['10.1038/s41432-019-0038-1']
2099,31819309,Effect of Fortification of Breast Milk in Conjugation with Protein Supplement on Neurodevelopment of Preterm Low Birth Weight Infants at 3 Years.,"Introduction


Choice of appropriate nutrition has a special place, which variations in dietary nutrient can potentially be involved in growth deficits in preterm neonates.
Aim


to investigate the effect of protein supplementation in very low birth weight (VLBW= birth weight under 1500 grams) infants on neurological growth in the third year of birth.
Material and Methods


We investigated neurological growth in two groups of control and intervention (each group, n= 18 subjects). The intervention group includes 3-year-old children who weighting less than 1200 grams at birth and have received protein supplementation at the course of NICU hospitalization, protein was added to maternal milk when the amount of milk reaches to 100 cc/kg/day, at this time parenteral nutrition was discontinued and the volume of feeding was increased 20cc/kg/day until reached to 150-180cc/kg/day. We also added the fortifier to breast milk at this time (FMS- Aptamil- DANON). The fortification and the protein supplementation were stopped when the weight of the baby reached to 1500 grams. The control group was fed similar to the intervention group, without protein supplemental intake. Neurodevelopmental outcomes were evaluated using ASQ, NEWSHA and BINS tools.
Results


There was no significant difference between the mean head circumference in the two groups (p=0.209). There was no significant relationship between neurological growth rate evaluated by BINS tool in two groups (p=0.266). There was a significant correlation between the neurological development assessed by the ASQ tool in the areas of communication (p=0.014) and gross motor (p=0.001) in the two groups, however, no significant relationship was found in terms of fine motor (p=0.63), problem solving (p=0.07) and personal-social relationships in both groups (p=0.152). There was a significant correlation between neurological development evaluated using the NEWSHA tool in terms of auditory (p=0.031), verbal language (p=0.024), cognitive (p=0.007), social connection (p=0.034) and motor (p=0.002) in the two groups.
Conclusion


Protein intake in preterm infants didn't reveal long term effects on the growth of head circumference. Moreover, it was capable of improving neurological growth in the areas of communication and gross motor (based on the ASQ) and auditory, verbal language, cognitive, social connection, and motor (based on the NEWSHA).",2019,problem solving (p=0.07) and personal-social relationships in both groups (p=0.152).,"['preterm infants', 'preterm neonates', 'two groups of control and intervention (each group, n= 18 subjects', 'Preterm Low Birth Weight Infants at 3 Years', 'very low birth weight (VLBW= birth weight under 1500 grams) infants on neurological growth in the third year of birth']","['intervention group, without protein supplemental intake', 'protein supplementation', '3-year-old children who weighting less than 1200 grams at birth and have received protein supplementation', 'Fortification of Breast Milk in Conjugation with Protein Supplement']","['personal-social relationships', 'neurological growth rate', 'verbal language', 'mean head circumference', 'growth of head circumference', 'social connection', 'auditory, verbal language, cognitive, social connection, and motor (based on the NEWSHA']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021288', 'cui_str': 'Low Birth Weight Infant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0449249', 'cui_str': 'Growth rate (attribute)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",18.0,0.0227737,problem solving (p=0.07) and personal-social relationships in both groups (p=0.152).,"[{'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Kashaki', 'Affiliation': 'Shahid Akbarabadi Clinical Research Development Unit (ShACRDU), Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Fatemeh Masoudi', 'Initials': 'FM', 'LastName': 'Samghabadi', 'Affiliation': 'Shahid Akbarabadi Clinical Research Development Unit (ShACRDU), Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Bordbar', 'Affiliation': 'Shahid Akbarabadi Clinical Research Development Unit (ShACRDU), Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]","Medical archives (Sarajevo, Bosnia and Herzegovina)",['10.5455/medarh.2019.73.344-350']
2100,32416376,Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT).,"BACKGROUND


Prostate stereotactic ablative radiotherapy (SABR) regimens differ in time, dose, and fractionation. We report an update of a multicentre, Canadian randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL), efficacy, and toxicity.
METHODS


Men with intermediate risk prostate cancer were randomized to 40 Gy in 5 fractions delivered every other day (EOD) versus once per week (QW). Primary outcome was proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC. Secondary outcomes were toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy.
FINDINGS


152 men from 3 centers were randomized; the median follow-up was 62 months. Results are described for EOD versus QW. Acute bowel and urinary QOL was reported previously. Late changes in QOL were not significantly different between the two arms. There were 1 (1.3%) vs 3 (2.7%) late grade 3 + GI toxicities (p = 0.36) and 5 (6.7%) vs 2 (2.7%) late grade 3 GU toxicities (p = 0.44). Two and 5 patients had BF (5-year failure rate 3.0 vs 7.2%, p = 0.22); 0 and 4 patients received salvage therapy (p = 0.04). 5-Year OS and CSS was 95.8% and 98.6% with no difference between arms (p = 0.49, p = 0.15). 3 patients in the QW arm developed metastases.
INTERPRETATION


Although we previously reported that weekly prostate SABR had better bowel and urinary QOL compared to EOD, the updated results show no difference in late toxicity, QOL, BF, or PSA kinetics. Patients should be counseled that QW SABR reduces short-term toxicity compared to QW SABR.",2020,Late changes in QOL were not significantly different between the two arms.,"['152 men from 3 centers', 'Men with intermediate risk prostate cancer']","['Accelerating prostate stereotactic ablative body radiotherapy', 'salvage therapy', 'Prostate stereotactic ablative radiotherapy (SABR']","['late toxicity, QOL, BF, or PSA kinetics', 'Late changes in QOL', 'proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC', 'Acute bowel and urinary QOL', 'bowel and urinary QOL', 'metastases', 'BF (5-year failure rate', 'late grade 3 GU toxicities', 'toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy', '5-Year OS and CSS', 'quality of life (QOL), efficacy, and toxicity', 'late grade 3\xa0+\xa0GI toxicities']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",152.0,0.180251,Late changes in QOL were not significantly different between the two arms.,"[{'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Alayed', 'Affiliation': 'Radiation Oncology Unit, Department of Medicine, College of Medicine and College of Medicine Research Center, King Saud University, Saudi Arabia; Oncology Center, King Saud University Medical City, Saudi Arabia; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Canada.'}, {'ForeName': 'Aldrich', 'Initials': 'A', 'LastName': 'Ong', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cheung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Vesprini', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Chowdhury', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Panjwani', 'Affiliation': 'BC Cancer Agency, Abbotsford, Canada.'}, {'ForeName': 'Geordi', 'Initials': 'G', 'LastName': 'Pang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Korol', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Boyd', 'Initials': 'B', 'LastName': 'McCurdy', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mamedov', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Deabreu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Institute of Health Policy Management and Evaluation, University of Toronto, Canada. Electronic address: andrew.loblaw@sunnybrook.ca.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.04.039']
2101,32416333,Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent AF (CONVERGE Trial): Rationale and design.,"Atrial fibrillation is the most common sustained arrhythmia affecting over 33 million people worldwide. Approximately 70% of AF patients have non-paroxysmal AF. As AF progresses from paroxysmal to non-paroxysmal forms, the prevalence of comorbidities increases. The efficacy of catheter ablation for persistent and long standing persistent (LSP) AF is <40%, often requiring multiple ablation procedures with greater cost and potentially more complications. There is an unmet need to effectively treat such patients. METHODS: CONVERGE is an investigational device exempt, prospective, multi-center, open label 2:1 randomized controlled pivotal study to evaluate the overall success of the Convergent hybrid procedure compared to endocardial catheter ablation for the treatment of symptomatic persistent AF refractory or intolerant to at least one Class I and /or III anti-arrhythmic drug (AAD). A total of 153 subjects at 27 centers are treated in the study. The CONVERGE study is differentiated from other studies currently being conducted on the persistent AF population, because a) there is no time restriction on the duration of diagnosed AF in the patients being studied and b) the trial allows patients with left atrial sizes up to 6 centimeters. The ongoing trials are limited to either 6 months, 12 months or 3-years of continuous AF making CONVERGE the only ablation trial thus far to include a substantial portion of patients with longstanding persistent AF. The convergent procedure involves combination of minimally invasive pericardioscopic epicardial ablation with endocardial left atrial ablation. The primary endpoint is freedom from AF/AFL/AF absent class I/III AAD, except for a previously failed class I/ III AAD with no increase in dosage following 3-months through 12-months. The primary safety endpoint is the incidence of major adverse events from the procedure through 30-days post procedure. CONCLUSION: CONVERGE AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF. By providing objective comparative data, the study aims to provide guidance on the treatment of such patients.",2020,AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF.,"['symptomatic persistent AF refractory or intolerant to at least one Class I and /or III anti-arrhythmic drug (AAD', '153 subjects at 27 centers are treated in the study', 'patients with longstanding persistent AF', 'patients with left atrial sizes up to 6 centimeters']","['minimally invasive pericardioscopic epicardial ablation with endocardial left atrial ablation', 'catheter ablation', 'Epicardial and Endocardial RF Ablation', 'endocardial catheter ablation']","['freedom from AF/AFL/AF absent class I/III AAD', 'incidence of major adverse events']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0475210', 'cui_str': 'cm'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0442016', 'cui_str': 'Epicardial'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0014124', 'cui_str': 'Endocardial'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",153.0,0.021211,AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF.,"[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'DeLurgio', 'Affiliation': ""Emory St. Joseph's Hospital, Atlanta, GA.""}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ferguson', 'Affiliation': 'North Mississippi Medical Center, Tupelo, MS.'}, {'ForeName': 'Jaswinder', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': ""Guy's and St. Thomas's Hospital, London, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Blauth', 'Affiliation': ""Guy's and St. Thomas's Hospital, London, UK.""}, {'ForeName': 'Saumil', 'Initials': 'S', 'LastName': 'Oza', 'Affiliation': ""St Vincent's Medical Center, Jacksonville, FL.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mostovych', 'Affiliation': ""St Vincent's Medical Center, Jacksonville, FL.""}, {'ForeName': 'Yashasvi', 'Initials': 'Y', 'LastName': 'Awasthi', 'Affiliation': 'AtriCure, Inc., Mason, OH. Electronic address: yawasthi@atricure.com.'}, {'ForeName': 'Nfii', 'Initials': 'N', 'LastName': 'Ndikintum', 'Affiliation': 'AtriCure, Inc., Mason, OH.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Crossen', 'Affiliation': 'North Mississippi Medical Center, Tupelo, MS.'}]",American heart journal,['10.1016/j.ahj.2020.02.016']
2102,27060705,The impact of maternal diet fortification with lipid-based nutrient supplements on postpartum depression in rural Malawi: a randomised-controlled trial.,"Perinatal depression is highly prevalent in low-and-middle-income countries and has been linked to poor child health. Suboptimal maternal nutrition may be a risk factor for perinatal depression. In this randomised-controlled trial conducted in rural Malawi, we set out to test the hypothesis that women taking a fatty acid-rich lipid-based nutrient supplement (LNS) would have fewer depressive symptoms postpartum than those taking iron-folate (IFA) or multiple-micronutrient (MMN) capsules. Women were recruited from antenatal clinics and randomised to receive LNS or MMN during pregnancy and for 6 months postpartum, or IFA during pregnancy only. Maternal depressive symptoms were measured using validated translations of the Self Reporting Questionnaire (SRQ) and Edinburgh Postnatal Depression Scale (EPDS), antenatally (SRQ only) and at 6 months postpartum (SRQ and EPDS). Analysis was by modified intention to treat. One thousand three hundred and ninety one women were randomised (LNS = 462, MMN = 466, IFA = 463). The groups were similar across a range of baseline variables. At 6 months postpartum, 1078 (77.5%) had SRQ completed; mean (SD) scores were LNS 1.76(2.73), MMN 1.92(2.75), IFA 1.71(2.66), P = 0.541. One thousand and fifty seven (76.0%) had EPDS completed; mean (SD) scores were LNS 5.77(5.53), MMN 5.43(4.97), IFA 5.52(5.18), P = 0.676. There were no statistically significant differences between the groups on SRQ or EPDS scores (continuous or dichotomised) in unadjusted or adjusted models. In conclusion, fortification of maternal diet with LNS compared with MMN or IFA did not reduce postnatal depressive symptoms in this study.",2017,There were no statistically significant differences between the groups on SRQ or EPDS scores (continuous or dichotomised) in unadjusted or adjusted models.,"['postpartum depression in rural Malawi', 'Women were recruited from antenatal clinics', 'One thousand three hundred and ninety one women were randomised (LNS\u2009=\u2009462, MMN\u2009=\u2009466, IFA\u2009=\u2009463']","['maternal diet fortification with lipid-based nutrient supplements', 'LNS or MMN', 'fatty acid-rich lipid-based nutrient supplement (LNS', 'MMN or IFA', 'taking iron-folate (IFA) or multiple-micronutrient (MMN) capsules']","['postnatal depressive symptoms', 'Self Reporting Questionnaire (SRQ) and Edinburgh Postnatal Depression Scale (EPDS), antenatally (SRQ only) and at 6\u2009months postpartum (SRQ and EPDS', 'SRQ or EPDS scores', 'Maternal depressive symptoms']","[{'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C4517571', 'cui_str': '1390 (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",1391.0,0.383008,There were no statistically significant differences between the groups on SRQ or EPDS scores (continuous or dichotomised) in unadjusted or adjusted models.,"[{'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Stewart', 'Affiliation': 'Manchester Mental Health and Social Care NHS Trust, Manchester, UK and Institute of Brain, Behaviour and Mental Health, University of Manchester, UK.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Department for International Health, University of Tampere School of Medicine, Finland and Department of Pediatrics, Tampere University Hospital, Finland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Umar', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Malawi.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, Davis, USA.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Department for International Health, University of Tampere School of Medicine, Finland.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Creed', 'Affiliation': 'Institute of Brain, Behaviour and Mental Health, University of Manchester, UK.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Institute of Psychology, Health and Society, University of Liverpool, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Tomenson', 'Affiliation': 'Biostatistics Unit, Institute of Population Health, University of Manchester, UK.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Prado', 'Affiliation': 'Department of Nutrition, University of California, Davis, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Malawi.'}]",Maternal & child nutrition,['10.1111/mcn.12299']
2103,27072591,Omega-3 LCPUFA supplement: a nutritional strategy to prevent maternal and neonatal oxidative stress.,"There is controversy about fish-oil supplementation and oxidative damage. This ambiguity should be explored to elucidate its role as modulator of oxidative stress, especially during gestation and postnatal life. This is the objective of this study. One hundred ten pregnant women were divided in two groups: control group CT (400 mL/day of the control dairy drink); supplemented group FO (400 mL/day of the fish oil-enriched dairy drink (±400-mg EPA-DHA/day)). Different biomarkers of oxidative damage were determined in the mother's at enrolment, at delivery and at 2.5 and 4 months postpartum and newborns at delivery and at 2.5 months postpartum. Omega-3 LC-PUFA supplementation during pregnancy and lactation decreased plasma hydroperoxides especially in newborn at delivery (P = 0.001) and 2.5 months (P = 0.006), increased superoxide dismutase (SOD) and catalase (CAT) in mothers at delivery (P = 0.024 (SOD)) and after 2.5 months (P = 0.040 (CAT)) and in newborns at 2.5 months (P = 0.035 (SOD); P = 0.021 (CAT)). Also, supplementation increased α-tocoferol in mothers at 2.5 months (P = 0.030) and in umbilical cord artery (P = 0.039). Higher levels of CoQ10 were found in mothers at delivery (P = 0.039) as well as in umbilical cord vein (P = 0.024) and artery (P = 0.036). Our supplementation prevents the oxidative stress in the mother and neonate during the first months of postnatal life, being a potential preventive nutritional strategy to prevent functional alterations associated with oxidative stress that have an important repercussion for the neonate development in the early postnatal life.",2017,"Omega-3 LC-PUFA supplementation during pregnancy and lactation decreased plasma hydroperoxides especially in newborn at delivery (P = 0.001) and 2.5 months (P = 0.006), increased superoxide dismutase (SOD) and catalase (CAT) in mothers at delivery (P = 0.024 (SOD)) and after 2.5 months (P = 0.040 (CAT)) and in newborns at 2.5 months (P = 0.035 (SOD); P = 0.021 (CAT)).",['One hundred ten pregnant women'],"['Omega-3 LCPUFA supplement', 'control group CT (400\u2009mL/day of the control dairy drink); supplemented group FO (400\u2009mL/day of the fish oil-enriched dairy drink', 'Omega-3 LC-PUFA supplementation']","['plasma hydroperoxides', 'superoxide dismutase (SOD) and catalase (CAT', 'oxidative stress', 'Higher levels of CoQ10', 'α-tocoferol', 'umbilical cord vein']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439446', 'cui_str': 'mL/day'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0042449', 'cui_str': 'Veins'}]",110.0,0.0546527,"Omega-3 LC-PUFA supplementation during pregnancy and lactation decreased plasma hydroperoxides especially in newborn at delivery (P = 0.001) and 2.5 months (P = 0.006), increased superoxide dismutase (SOD) and catalase (CAT) in mothers at delivery (P = 0.024 (SOD)) and after 2.5 months (P = 0.040 (CAT)) and in newborns at 2.5 months (P = 0.035 (SOD); P = 0.021 (CAT)).","[{'ForeName': 'Naroa', 'Initials': 'N', 'LastName': 'Kajarabille', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, University of Granada, Granada, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Hurtado', 'Affiliation': 'Department of Neonatology, Hospital Materno Infantil Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Peña-Quintana', 'Affiliation': 'Gastroenterology and Pediatric Nutrition Unit, Complejo Hospitalario Universitario Insular Materno-Infantil, Las Palmas, Spain.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Peña', 'Affiliation': 'Department of Neonatology, Hospital Materno Infantil Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Josefa', 'Initials': 'J', 'LastName': 'Ruiz', 'Affiliation': 'Department of Neurophysiology, Hospital Materno Infantil Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Diaz-Castro', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, University of Granada, Granada, Spain.'}, {'ForeName': 'Yessica', 'Initials': 'Y', 'LastName': 'Rodríguez-Santana', 'Affiliation': 'Gastroenterology and Pediatric Nutrition Unit, Complejo Hospitalario Universitario Insular Materno-Infantil, Las Palmas, Spain.'}, {'ForeName': 'Estefania', 'Initials': 'E', 'LastName': 'Martin-Alvarez', 'Affiliation': 'Department of Neonatology, Hospital Materno Infantil Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'López-Frias', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, University of Granada, Granada, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Soldado', 'Affiliation': 'Department Obstetrics and Gynecology, Complejo Hospitalario Universitario Insular Materno-Infantil, Las Palmas, Spain.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Lara-Villoslada', 'Affiliation': 'Research and Development Department, Lactalis Puleva, Granada, Spain.'}, {'ForeName': 'Julio J', 'Initials': 'JJ', 'LastName': 'Ochoa', 'Affiliation': 'Department of Physiology, Faculty of Pharmacy, University of Granada, Granada, Spain.'}]",Maternal & child nutrition,['10.1111/mcn.12300']
2104,32416406,The effect of a running training intervention on ankle power generation in children and adolescents with cerebral palsy: A randomized controlled trial.,"BACKGROUND


Children and adolescents with cerebral palsy who are classified as Gross Motor Function Classification Scale level I or II are usually able to run but lack ankle power generation for push-off. The aim of this study was to analyze the efficacy of a running training program in improving ankle power generation in children and adolescents with cerebral palsy.
METHODS


This randomized controlled trial compared kinematic and spatiotemporal data collected during running from 38 children and adolescents with unilateral or bilateral cerebral palsy before and after a 12-week running program. Normalized speed, stride length, cadence, foot strike pattern, peak ankle power generation, peak hip flexor power generation in swing and propulsion strategy were calculated. Linear mixed models were developed to analyze differences between groups.
FINDINGS


At follow-up the intervention group had increased normalized speed of running (t = -3.68 p < .01) while the control group got slower (t = 3.17 p < .01). In running, children in Gross Motor Function Classification Scale level II in the intervention group increased ankle power (t = 2.49 p = .01) while the control group did not change (t = 0.38 p = .71). In sprinting, children in Gross Motor Function Classification Scale levels I and II in the intervention group maintained ankle power (level I t = 0.32 p = .75; level II t = 1.56 p = .12) while those in the control group decreased ankle power (level I t = 4.69 p < .01; level II t = 2.52 p = .01). Most within-group differences did not result in significant between-group differences at follow-up.
INTERPRETATION


Power generation for running may be responsive to targeted intervention in children with cerebral palsy.",2020,"In sprinting, children in Gross Motor Function Classification Scale levels I and II in the intervention group maintained ankle power (level","['38 children and adolescents with unilateral or bilateral cerebral palsy before and after a 12-week running program', 'children with cerebral palsy', 'Children and adolescents with cerebral palsy', 'children and adolescents with cerebral palsy']","['running training program', 'running training intervention']","['normalized speed of running', 'Normalized speed, stride length, cadence, foot strike pattern, peak ankle power generation, peak hip flexor power generation in swing and propulsion strategy', 'Gross Motor Function Classification Scale level', 'ankle power (level', 'ankle power']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C3838784', 'cui_str': 'Bilateral cerebral palsy'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",38.0,0.0435438,"In sprinting, children in Gross Motor Function Classification Scale levels I and II in the intervention group maintained ankle power (level","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chappell', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia, Australia; Ability Centre, Coolbinia, Western Australia, Australia. Electronic address: annie.chappell@abilitycentre.com.au.'}, {'ForeName': 'G T', 'Initials': 'GT', 'LastName': 'Allison', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Williams', 'Affiliation': 'School of Health Sciences, University of Melbourne, Victoria, Australia; Epworth HealthCare, Victoria, Australia. Electronic address: gavin.williams@epworth.org.au.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gibson', 'Affiliation': ""School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia, Australia; Ability Centre, Coolbinia, Western Australia, Australia; Perth Children's Hospital, Perth, Western Australia, Australia. Electronic address: noula.gibson@health.wa.gov.au.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia, Australia.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105024']
2105,31557679,"Early initiation of fingolimod reduces the rate of severe relapses over the long term: Post hoc analysis from the FREEDOMS, FREEDOMS II, and TRANSFORMS studies.","BACKGROUND


Relapse frequency is often correlated with the prognosis of multiple sclerosis (MS). In patients with relapsing-remitting MS (RRMS), relapses vary in severity and may affect activities of daily living, require steroid intervention, or hospitalization. Incomplete recovery from relapses results in increasing disability. In pivotal phase III studies of fingolimod (FREEDOMS, FREEDOMS II, and TRANSFORMS), the frequency of overall and severe relapses was significantly reduced in patients with RRMS treated with fingolimod compared with placebo or intramuscular interferon β-1a (IFN β-1a). The objective of this study was to report the effect of early initiation of fingolimod on relapse severity in patients with RRMS.
METHODS


This is a post hoc descriptive analysis of data from the pooled placebo-controlled FREEDOMS/FREEDOMS II studies and from the active-comparator TRANSFORMS study. Patients were analyzed under 2 groups: patients initially randomized to receive fingolimod 0.5 mg during the core phase and continued fingolimod 0.5 mg in the extension phase (immediate fingolimod group), and patients initially randomized to placebo or IFN β-1a during the core phase and switched to fingolimod during the extension phase (delayed fingolimod group). Annualized relapse rate (ARR) was estimated for severe relapses (defined as Expanded Disability Status Scale increase of >1 point, or >2-point change in 1 or 2 Functional Systems, respectively, or >1-point change in >4 Functional Systems). ARR was also estimated for relapses that affected activities of daily living, required steroid use, or hospitalization.
RESULTS


In the pooled FREEDOMS/FREEDOMS II extensions, the immediate fingolimod group showed sustained reductions in the proportion (core: 15.8% and extension: 9.3%) and in ARR over 4 years (0.032 and 0.015) for severe relapses, in relapses requiring steroids (0.149 and 0.123), hospitalization (0.049 and 0.039) and relapses affecting activities of daily living (0.155 and 0.112). In the TRANSFORMS extension, similar reductions were observed in the immedaite group for the proportion of severe relapses (core: 11.8% and extension: 9.8%). ARR remained low over 2 years for severe relapses (0.024 and 0.018), relapses affecting activities of daily living (0.112 and 0.109), relapses requiring steroids (0.156 and 0.161) and hospitalization (0.027 and 0.033). Results in the FREEDOMS/FREEDOMS II and TRANSFORMS extensions for the delayed group were similar. In the TRANSFORMS extension, the proportion of severe relapses were 18.0% (core) and 11.1% (extension); there were significant reductions in ARR for severe relapses (core: 0.079 and extension: 0.029), relapses requiring steroids (0.366 and 0.232), hospitalization (0.092 and 0.055), and relapses affecting activities of daily living (0.285 and 0.144) (all p < 0.0001). Complete recovery was reported for the majority of relapses during the core and extension phases in both the immediate and delayed fingolimod groups (Pooled FREEDOMS/FREEDOMS II: immediate group 59.7%-65.5% and delayed group 64.9%-67.7%; TRANSFORMS: 72.1%-80.0% and 65.4%-70.8%).
CONCLUSIONS


In patients with RRMS, the frequency of severe relapses and relapse severity remained low in the immedaite fingolimod group over a period of 4 years. Reductions in the proportion of severe relapses post switch from IFN β-1a or placebo to fingolimod underscore the clinical benefit and the relevance of an early initiation of fingolimod.",2019,"ARR remained low over 2 years for severe relapses (0.024 and 0.018), relapses affecting activities of daily living (0.112 and 0.109), relapses requiring steroids (0.156 and 0.161) and hospitalization (0.027 and 0.033).","['patients with RRMS treated with fingolimod compared with', 'patients with relapsing-remitting MS (RRMS', 'patients with RRMS']","['placebo', 'placebo or intramuscular interferon β-1a (IFN β-1a', 'fingolimod 0.5\u202fmg during the core phase and continued fingolimod 0.5 mg in the extension phase (immediate fingolimod group', 'placebo or IFN β-1a']","['Complete recovery', 'proportion of severe relapses', 'rate of severe relapses', 'severe relapses', 'Annualized relapse rate (ARR', 'relapses affecting activities of daily living', 'ARR for severe relapses', 'frequency of overall and severe relapses', 'hospitalization', 'ARR', 'frequency of severe relapses and relapse severity', 'relapses requiring steroids']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C2938759', 'cui_str': 'fingolimod 0.5 MG'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]",,0.0402633,"ARR remained low over 2 years for severe relapses (0.024 and 0.018), relapses affecting activities of daily living (0.112 and 0.109), relapses requiring steroids (0.156 and 0.161) and hospitalization (0.027 and 0.033).","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Haas', 'Affiliation': 'Center for Multiple Sclerosis, Jewish Hospital, Berlin, Germany. Electronic address: Haas-heide@gmx.de.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Jeffery', 'Affiliation': 'Piedmont Health Care, Mooresville, NC, USA.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Silva', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Daniela Piani', 'Initials': 'DP', 'LastName': 'Meier', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Meinert', 'Affiliation': 'DATAMAP GmbH, Freiburg, Germany.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2019.07.011']
2106,32416434,The immediate effects of a shoulder brace on muscle activity and scapular kinematics in subjects with shoulder impingement syndrome and rounded shoulder posture: A randomized crossover design.,"BACKGROUND


Round shoulder posture (RSP) is one of the potential risks for shoulder impingement syndrome (SIS) due to alignment deviation of the scapula. Evidence on how the characteristics of a shoulder brace affecting the degree of RSP, shoulder kinematics, and associated muscle activity during movements is limited.
RESEARCH QUESTION


The purposes of this study were (1) to compare the effects of a shoulder brace on clinical RSP measurements, muscle activities and scapular kinematics during arm movements in subjects with shoulder impingement syndrome (SIS) and RSP; and (2) to compare the effects of two configurations (parallel and diagonal) and two tensions (comfortable and forced tension) of the brace straps on muscle activities and scapular kinematics during arm movements in subjects with SIS and RSP.
METHODS


Twenty-four participants (12 males; 12 females) with SIS and RSP were randomly assigned into 2 groups (comfortable then forced, and forced then comfortable) with 2 strap configurations in each tension condition. The pectoralis minor index (PMI), acromial distance (AD) and shoulder angle (SA) were used to assess the degree of RSP. Three-dimensional electromagnetic motion analysis and electromyography were used to record the scapular kinematics and muscle activity during arm movements.
RESULTS


All clinical measurements with the brace were significantly improved (p < 0.05). Under forced tension, muscle activities were higher with the diagonal configuration than with the parallel configuration in the lower trapezius (LT) (1.2-2.3% MVIC, p < 0.05) and serratus anterior (SA) (2.3% MVIC, p = 0.015). For upward rotation and posterior tilting of the scapula, the diagonal configuration was larger than the parallel configuration (1.5°, p = 0.038; 0.4°-0.5°, p < 0.05, respectively).
SIGNIFICANCE


Different characteristics of the straps of the shoulder brace could alter muscle activity and scapular kinematics at different angles during arm movement. Based on the clinical treatment preference, the application of a shoulder brace with a diagonal configuration and forced tension is suggested for SIS and RSP subjects.",2020,All clinical measurements with the brace were significantly improved (p < 0.05).,"['subjects with SIS and RSP.\nMETHODS\n\n\nTwenty-four participants (12 males; 12 females) with SIS and RSP', 'subjects with shoulder impingement syndrome (SIS) and RSP; and (2', 'subjects with shoulder impingement syndrome and rounded shoulder posture']","['Round shoulder posture (RSP', 'shoulder brace', 'two configurations (parallel and diagonal) and two tensions (comfortable and forced tension) of the brace straps']","['pectoralis minor index (PMI), acromial distance (AD) and shoulder angle (SA', 'Under forced tension, muscle activities', 'muscle activity and scapular kinematics', 'clinical RSP measurements, muscle activities and scapular kinematics', 'serratus anterior (SA) ']","[{'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0443198', 'cui_str': 'Diagonal'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0183631', 'cui_str': 'Strap'}]","[{'cui': 'C0224347', 'cui_str': 'Pectoralis minor muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C2717795', 'cui_str': 'Clinical Rounds'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",24.0,0.0621097,All clinical measurements with the brace were significantly improved (p < 0.05).,"[{'ForeName': 'Yuan-Chun', 'Initials': 'YC', 'LastName': 'Chiu', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Yung-Shen', 'Initials': 'YS', 'LastName': 'Tsai', 'Affiliation': 'Department of Sports Sciences and Institute of Sports Equipment Technology, University of Taipei, Taiwan.'}, {'ForeName': 'Chien-Lung', 'Initials': 'CL', 'LastName': 'Shen', 'Affiliation': 'Department of Products, Taiwan Textile Research Institute, Taiwan.'}, {'ForeName': 'Tyng-Guey', 'Initials': 'TG', 'LastName': 'Wang', 'Affiliation': 'Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan.'}, {'ForeName': 'Jing-Lan', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan. Electronic address: yangjinglan@gmail.com.'}, {'ForeName': 'Jiu-Jenq', 'Initials': 'JJ', 'LastName': 'Lin', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan; Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan. Electronic address: jiujlin@ntu.edu.tw.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.028']
2107,27145299,Evaluation of the effects of iodized salt on the mental development of preschool-aged children: a cluster randomized trial in northern Ethiopia.,"A cluster randomized effectiveness trial was used to examine the effects on mental development of introducing iodized salt to children 4 to 6 years of age in Ethiopia, where there were reportedly high levels of iodine deficiency. Sixty district clusters were randomized to receive iodized salt early at their markets with assistance from regular salt distributors or later as introduced by market forces. At pre- and post-iodization, 1602 children were given cognitive/language tests (namely School Readiness, WPPSI verbal reasoning, WPPSI Matrix reasoning), and mothers were interviewed concerning demographics, nutrition and health. Children's weight, height, urine and a blood sample were taken. Analyses of covariance, adjusting for clustering and baseline levels were conducted. Urinary iodine concentrations were significantly higher at endline in the intervention children than controls though both medians were above threshold. Overall, less than 5% were anemic. There were no significant main effect differences between groups on the cognitive/language tests, but there were effect modifiers, namely mother's education, child's sex and diet. For example, the intervention group performed better on the school readiness test than controls if their mothers had attended school, but not otherwise. In conclusion, the data are consistent with negative findings from studies where children 6 to 12 years were supplemented with an iodine capsule, indicating that the benefits of iodine, in salt or capsule form, for brain development may be restricted to children under 3 years. Yet, benefits may be tied to those with more educational resources or may compensate for conditions of disadvantage.",2017,"There were no significant main effect differences between groups on the cognitive/language tests, but there were effect modifiers, namely mother's education, child's sex and diet.","['northern Ethiopia', 'preschool-aged children', 'Sixty district clusters', '1602 children were given', 'children 4 to 6\u2009years of age in Ethiopia']","['iodized salt early at their markets with assistance from regular salt distributors or later as introduced by market forces', 'iodized salt']","['cognitive/language tests (namely School Readiness, WPPSI verbal reasoning, WPPSI Matrix reasoning', 'Urinary iodine concentrations', 'cognitive/language tests']","[{'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0063758', 'cui_str': 'iodinated salt'}]","[{'cui': 'C0023016', 'cui_str': 'Language Tests'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C2828074', 'cui_str': 'Wechsler Preschool and Primary Scale of Intelligence'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",1602.0,0.0354297,"There were no significant main effect differences between groups on the cognitive/language tests, but there were effect modifiers, namely mother's education, child's sex and diet.","[{'ForeName': 'Frances E', 'Initials': 'FE', 'LastName': 'Aboud', 'Affiliation': 'Department of Psychology, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Bougma', 'Affiliation': 'School of Dietetics and Human Nutrition, McGill University, Sainte Anne-de-Bellevue, Québec, Canada.'}, {'ForeName': 'Tizita', 'Initials': 'T', 'LastName': 'Lemma', 'Affiliation': 'Department of Psychology, Bahir Dar University, Bahir Dar, Ethiopia.'}, {'ForeName': 'Grace S', 'Initials': 'GS', 'LastName': 'Marquis', 'Affiliation': 'School of Dietetics and Human Nutrition, McGill University, Sainte Anne-de-Bellevue, Québec, Canada.'}]",Maternal & child nutrition,['10.1111/mcn.12322']
2108,27146248,Effects of an intervention on infant growth and development: evidence for different mechanisms at work.,"Millions of children in low-income and middle-income countries falter in linear growth and neurobehavioral development early in life. This faltering may be caused by risk factors that are associated with both growth and development, such as insufficient dietary intake and infection in infancy. Alternatively, these risk factors may be indicative of an environment that constrains both linear growth and development through different mechanisms. In a cluster-randomized trial in Burkina Faso, we previously found that provision of lipid-based nutrient supplements plus malaria and diarrhoea treatment from age 9 to 18 months resulted in positive effects of ~0.3 standard deviation on length-for-age z-score (LAZ) and of ~0.3 standard deviation on motor, language and personal-social development scores at age 18 months. In this paper, we examined whether the effect of the intervention on developmental scores was mediated by the effect on LAZ, or, alternatively, whether the intervention had independent effects on growth and development. For motor, language, and personal-social z-scores, the effect of the intervention decreased from 0.32 to 0.21, from 0.33 to 0.27 and from 0.35 to 0.29, respectively, when controlling for change in LAZ from 9 to 18 months. All effects remained significant. These results indicate that the intervention had independent positive effects on linear growth and development, suggesting that these effects occurred through different mechanisms. © 2016 John Wiley & Sons Ltd.",2017,"For motor, language, and personal-social z-scores, the effect of the intervention decreased from 0.32 to 0.21, from 0.33 to 0.27 and from 0.35 to 0.29, respectively, when controlling for change in LAZ from 9 to 18 months.","['from age 9 to 18\u2009months resulted in positive effects of ~0.3 standard deviation on length-for-age z-score (LAZ) and of ~0.3 standard deviation on motor, language and personal-social development scores at age 18\u2009months']",['lipid-based nutrient supplements plus malaria and diarrhoea treatment'],"['For motor, language, and personal-social z-scores', 'developmental scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0037409', 'cui_str': 'Social Development'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0373523,"For motor, language, and personal-social z-scores, the effect of the intervention decreased from 0.32 to 0.21, from 0.33 to 0.27 and from 0.35 to 0.29, respectively, when controlling for change in LAZ from 9 to 18 months.","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Prado', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Souheila', 'Initials': 'S', 'LastName': 'Abbeddou', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Yakes Jimenez', 'Affiliation': 'Departments of Individual, Family, and Community Education and Family and Community Medicine, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Jérôme W', 'Initials': 'JW', 'LastName': 'Somé', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Brown', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Sonja Y', 'Initials': 'SY', 'LastName': 'Hess', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12314']
2109,32419491,Short- and Midterm Adherence to Platelet P2Y12 Receptor Inhibitors After Percutaneous Coronary Intervention With Drug-Eluting Stents.,"INTRODUCTION/OBJECTIVES


In patients who have undergone recent percutaneous coronary intervention (PCI), poor adhesion to antiplatelet agents may increase the risk of stent thrombosis and death. We aimed to investigate the adherence to different P2Y12 receptor inhibitors after PCI with drug-eluting stent in stable and unstable patients and to evaluate the factors associated with low adherence.
METHOD


In a prospective study conducted between 2014 and 2018, the 8-item Morisky scale was applied at 30 days and 6 months post-PCI to measure P2Y12 receptor inhibitors adherence. Also, we describe the characteristics of patients using different platelet receptor P2Y12 inhibitors. Regression models were used to identify predictors of poor adherence.
RESULTS


A total of 214 patients were included (65 ± 12 years, 81% man, 61% acute coronary syndromes). Patients in the clopidogrel group were older than those in the prasugrel (68 ± 12 vs 59 ± 11 years,  P  < .01, respectively) or ticagrelor group (68 ± 12 vs 62 ± 12 years,  P  < .01). Patients with low/moderate adherence at 30 days and 6 months represented, respectively, 19.8% and 27.5% of our sample. Current smokers and preexisting cardiovascular disease at presentation were associated with lower adherence at 30 days.
CONCLUSIONS


We found substantial rates of moderate and low adherence to P2Y12 receptor inhibitors early after PCI. Current smokers and preexisting cardiovascular disease at presentation were associated with a lower likelihood of adherence. These results highlight the need of monitoring adherence to medical treatment after PCI.",2020,"Patients in the clopidogrel group were older than those in the prasugrel (68 ± 12 vs 59 ± 11 years,  P  < .01, respectively) or ticagrelor group (68 ± 12 vs 62 ± 12 years,  P  < .01).","['A total of 214 patients were included (65 ± 12 years, 81% man, 61% acute coronary syndromes', 'patients who have undergone recent percutaneous coronary intervention (PCI']","['Percutaneous Coronary Intervention With Drug-Eluting Stents', 'Platelet P2Y12 Receptor Inhibitors', 'clopidogrel', 'ticagrelor']",['risk of stent thrombosis and death'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",214.0,0.0204004,"Patients in the clopidogrel group were older than those in the prasugrel (68 ± 12 vs 59 ± 11 years,  P  < .01, respectively) or ticagrelor group (68 ± 12 vs 62 ± 12 years,  P  < .01).","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Morita', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Wajngarten', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Katz', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Morita Fernandes-Silva', 'Affiliation': 'Department of Internal Medicine, Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Caixeta', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Franken', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Lemos', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Antonio E', 'Initials': 'AE', 'LastName': 'Pesaro', 'Affiliation': 'Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420926667']
2110,26901374,Balancing Effort and Information Transmission During Language Acquisition: Evidence From Word Order and Case Marking.,"Across languages of the world, some grammatical patterns have been argued to be more common than expected by chance. These are sometimes referred to as (statistical) language universals. One such universal is the correlation between constituent order freedom and the presence of a case system in a language. Here, we explore whether this correlation can be explained by a bias to balance production effort and informativity of cues to grammatical function. Two groups of learners were presented with miniature artificial languages containing optional case marking and either flexible or fixed constituent order. Learners of the flexible order language used case marking significantly more often. This result parallels the typological correlation between constituent order flexibility and the presence of case marking in a language and provides a possible explanation for the historical development of Old English to Modern English, from flexible constituent order with case marking to relatively fixed order without case marking. In addition, learners of the flexible order language conditioned case marking on constituent order, using more case marking with the cross-linguistically less frequent order, again mirroring typological data. These results suggest that some cross-linguistic generalizations originate in functionally motivated biases operating during language learning.",2017,Learners of the flexible order language used case marking significantly more often.,[],['miniature artificial languages containing optional case marking and either flexible or fixed constituent order'],[],[],"[{'cui': 'C0574212', 'cui_str': 'Artificial language (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0729650', 'cui_str': 'Constituents (substance)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]",[],,0.0246901,Learners of the flexible order language used case marking significantly more often.,"[{'ForeName': 'Maryia', 'Initials': 'M', 'LastName': 'Fedzechkina', 'Affiliation': 'Department of Psychology, University of Pennsylvania.'}, {'ForeName': 'Elissa L', 'Initials': 'EL', 'LastName': 'Newport', 'Affiliation': 'Department of Neurology, Center for Brain Plasticity and Recovery, Georgetown University.'}, {'ForeName': 'T Florian', 'Initials': 'TF', 'LastName': 'Jaeger', 'Affiliation': 'Department of Brain & Cognitive Sciences, University of Rochester.'}]",Cognitive science,['10.1111/cogs.12346']
2111,32419349,Prophylactic Foley catheter insertion into defunctioning ileostomy to reduce obstruction after colorectal surgery: pilot randomized controlled trial.,"BACKGROUND


Defunctioning ileostomies provide faecal diversion in major colorectal surgery. This reduces the consequences of an anastomotic leak. However, the formation of an ileostomy carries risks including obstruction at the level of the fascia. Post-operative oedema at the level of the fascia may contribute to obstruction. We hypothesize that the prophylactic insertion of a Foley catheter into the afferent limb of a defunctioning loop ileostomy may help decompress and improve time to low-residue diet (LRD). The objective of the study was to assess the feasibility of a Foley catheter, prophylactically inserted into the afferent limb of a defunctioning loop ileostomy, after major colorectal surgery.
METHODS


The study was a prospective pilot-randomized controlled trial. Ethical approval was obtained from Northern B Health and Disability Ethics Committee 15/NTB/91 ANZCTR Trial ID: ACTRN12615000691549.
RESULTS


Forty-nine patients undergoing major elective colorectal surgery with a defunctioning ileostomy, between the years of 2015 and 2018 at North Shore Hospital, Auckland, New Zealand were included in this study. Patients were randomly allocated to either the Foley catheter (n = 26) or non-Foley catheter (n = 23) group. The median time taken to tolerate LRD the primary outcome, was 2 days in the Foley group versus 2 days in the non-Foley group (P = 0.05). There were no differences in the secondary outcome measures such as time to stoma output, length of stay or complications.
CONCLUSION


This trial failed to show a statistical difference in time taken to tolerate a LRD residue in the Foley catheter group. There was no difference in length of stay, time to flatus or stoma output.",2020,This trial failed to show a statistical difference in time taken to tolerate a LRD residue in the Foley catheter group.,"['major colorectal surgery', 'Forty-nine patients undergoing major elective colorectal surgery with a defunctioning ileostomy, between the years of 2015 and 2018 at North Shore Hospital, Auckland, New Zealand were included in this study']","['Foley catheter, prophylactically inserted into the afferent limb of a defunctioning loop ileostomy', 'Prophylactic Foley catheter insertion into defunctioning ileostomy', 'Foley catheter (n =\u200926) or non-Foley catheter']","['time to stoma output, length of stay or complications', 'median time taken to tolerate LRD', 'length of stay, time to flatus or stoma output']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0023985', 'cui_str': 'Creation of continent ileostomy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0425404', 'cui_str': 'Low residue diet'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}]",49.0,0.195566,This trial failed to show a statistical difference in time taken to tolerate a LRD residue in the Foley catheter group.,"[{'ForeName': 'Suheelan', 'Initials': 'S', 'LastName': 'Kulasegaran', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Nisbet', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Vasey', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Bacil', 'Initials': 'B', 'LastName': 'Otutaha', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': 'Planning, Funding and Outcomes, Waitemata and Auckland District Health Boards, Auckland, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jarvis', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Mike H', 'Initials': 'MH', 'LastName': 'Moir', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}]",ANZ journal of surgery,['10.1111/ans.15714']
2112,30484733,Subchronic treatment with St John's wort produces a positive shift in emotional processing in healthy volunteers.,"BACKGROUND


The neurocognitive model of antidepressant treatment in depression states that antidepressants work by producing relatively immediate positive shifts in emotional processing, which translate into clinical improvement with time. St John's Wort has shown antidepressant potential in randomised controlled trials; however, its pharmacological actions are broad and it is unknown whether treatment also produces changes in emotional processing.
AIMS


We investigated whether short-term treatment with St John's wort has similar effects on emotional processing to those reported with other antidepressants such as selective serotonergic reuptake inhibitors.
METHODS


Forty-eight healthy participants were given St John's wort or placebo treatment for seven days. On day 7 they completed a battery of tasks to measure emotional processing and other elements of cognition.
RESULTS


St John's wort treatment produced similar changes to other antidepressants, for example reducing recognition of disgusted faces and attention to fearful faces, while increasing memory for positive words. We failed to find evidence for an effect of St John's wort on other aspects of cognition including working memory.
CONCLUSIONS


These findings lend support to the theory that the production of early positive biases in emotional processing may be a common feature of all clinically effective antidepressants with diverse pharmacological mechanisms.",2019,"We failed to find evidence for an effect of St John's wort on other aspects of cognition including working memory.
","['Forty-eight healthy participants', 'healthy volunteers']",['placebo'],['emotional processing'],"[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",48.0,0.0924137,"We failed to find evidence for an effect of St John's wort on other aspects of cognition including working memory.
","[{'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Warren', 'Affiliation': '1 Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Cowen', 'Affiliation': '1 Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': '1 Department of Psychiatry, University of Oxford, Oxford, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881118812101']
2113,32419414,Does magnetic resonance imaging increase core body temperature in children? Results of the administration of propofol and ketofol: a randomized clinical study.,"BACKGROUND AND OBJECTIVES


Magnetic resonance imaging (MRI) may cause a temperature increase in the imaging area, while intravenous anesthetics may develop a tendency for hypothermia, especially in the pediatric population. The effect of different anesthetics on core body temperature in children during these procedures remains controversial. We examined the effect of propofol and ketofol on core body temperatures in a pediatric population during MRI. Our hypothesis was that the increase in body temperature will be more prominent in pediatric patients receiving ketofol than in those receiving propofol.
METHODS


This was a randomized, prospective, double-blind study in pediatric patients aged 6 months to 10 years. The patients were American Society of Anesthesiologist (ASA) physical class I-II who had undergone MRI under anesthesia at the Cerrahpasa School of Medicine, MRI Area, between August 2014 and February 2016. Patients were assigned to one of two groups: Group I (propofol group) and Group II (ketofol group). MRIs were performed with a 1.5 Tesla (T) device. Bilateral tympanic membrane temperature measurements before and after the procedure were performed.
RESULTS


Body temperature decreased in both groups after MRI. Clinically significant hypothermia or hyperthermia was not observed in any of the patients.
CONCLUSION


Temperature monitoring is not necessary for every patient being imaged. However, temperature changes should be closely monitored in high-risk patients.",2020,"Clinically significant hypothermia or hyperthermia was not observed in any of the patients.
","['pediatric patients receiving ketofol than in those receiving propofol', 'children during these procedures remains controversial', 'pediatric patients aged 6 months to 10 years', 'pediatric population during MRI', 'patients were American Society of Anesthesiologist (ASA) physical class I-II who had undergone MRI under anesthesia at the Cerrahpasa School of Medicine, MRI Area, between August 2014 and February 2016']","['Group I (propofol group) and Group II (ketofol group', 'propofol and ketofol', 'Magnetic resonance imaging (MRI']","['Body temperature', 'hypothermia or hyperthermia', 'body temperature', 'Bilateral tympanic membrane temperature measurements']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C1720436', 'cui_str': 'Under anesthesia'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0041445', 'cui_str': 'Tympanic membrane structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.0647189,"Clinically significant hypothermia or hyperthermia was not observed in any of the patients.
","[{'ForeName': 'Çiğdem Akyol', 'Initials': 'ÇA', 'LastName': 'Beyoğlu', 'Affiliation': 'Departments of Anesthesiology and Reanimation, İstanbul University Cerrahpasa Faculty of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Kendigelen', 'Affiliation': 'Departments of Anesthesiology and Reanimation, İstanbul University Cerrahpasa Faculty of Medicine, İstanbul, Turkey.'}, {'ForeName': 'İlhan', 'Initials': 'İ', 'LastName': 'Beyoğlu', 'Affiliation': 'Departments of Anesthesiology and Reanimation, İstanbul University Cerrahpasa Faculty of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Fatiş', 'Initials': 'F', 'LastName': 'Altındaş', 'Affiliation': 'Departments of Anesthesiology and Reanimation, İstanbul University Cerrahpasa Faculty of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Sebuh', 'Initials': 'S', 'LastName': 'Kuruoğlu', 'Affiliation': 'Departments of Radiodignostic and Interventional Radiology İstanbul University Cerrahpasa 2Radiodignostic and Interventional Radiology İstanbul University Cerrahpasa.'}, {'ForeName': 'Güner', 'Initials': 'G', 'LastName': 'Kaya', 'Affiliation': 'Departments of Anesthesiology and Reanimation, İstanbul University Cerrahpasa Faculty of Medicine, İstanbul, Turkey.'}]",The Turkish journal of pediatrics,['10.24953/turkjped.2020.02.008']
2114,32416781,"Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus placebo in patients with resected stage IV melanoma with no evidence of disease (IMMUNED): a randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND


Nivolumab and ipilimumab, alone or in combination, are widely used immunotherapeutic treatment options for patients with advanced-ie, unresectable or metastatic-melanoma. This criterion, however, excludes patients with stage IV melanoma with no evidence of disease. We therefore aimed to evaluate the safety and efficacy of adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus a placebo in this patient population.
METHODS


We did a randomised, double-blind, placebo-controlled, phase 2 trial in 20 German academic medical centres. Eligible patients were aged 18-80 years with stage IV melanoma with no evidence of disease after surgery or radiotherapy. Key exclusion criteria included uveal or mucosal melanoma, previous therapy with checkpoint inhibitors, and any previous immunosuppressive therapy within the 30 days before study drug administration. Eligible patients were randomly assigned (1:1:1), using a central, interactive, online system, to the nivolumab plus ipilimumab group (1 mg/kg of intravenous nivolumab every 3 weeks plus 3 mg/kg of intravenous ipilimumab every 3 weeks for four doses, followed by 3 mg/kg of nivolumab every 2 weeks), nivolumab monotherapy group (3 mg/kg of intravenous nivolumab every 2 weeks plus ipilimumab-matching placebo during weeks 1-12), or double-matching placebo group. The primary endpoint was the recurrence-free survival in the intention-to-treat population. The results presented in this report reflect the prespecified interim analysis of recurrence-free survival after 90 events had been reported. This study is registered with ClinicalTrials.gov, NCT02523313, and is ongoing.
FINDINGS


Between Sept 2, 2015, and Nov 20, 2018, 167 patients were randomly assigned to receive nivolumab plus ipilimumab (n=56), nivolumab (n=59), or placebo (n=52). As of July 2, 2019, at a median follow-up of 28·4 months (IQR 17·7-36·8), median recurrence-free survival was not reached in the nivolumab plus ipilimumab group, whereas median recurrence-free survival was 12·4 months (95% CI 5·3-33·3) in the nivolumab group and 6·4 months (3·3-9·6) in the placebo group. The hazard ratio for recurrence for the nivolumab plus ipilimumab group versus placebo group was 0·23 (97·5% CI 0·12-0·45; p<0·0001), and for the nivolumab group versus placebo group was 0·56 (0·33-0·94; p=0·011). In the nivolumab plus ipilimumab group, recurrence-free survival at 1 year was 75% (95% CI 61·0-84·9) and at 2 years was 70% (55·1-81·0); in the nivolumab group, 1-year recurrence-free survival was 52% (38·1-63·9) and at 2 years was 42% (28·6-54·5); and in the placebo group, this rate was 32% (19·8-45·3) at 1 year and 14% (5·9-25·7) at 2 years. Treatment-related grade 3-4 adverse events were reported in 71% (95% CI 57-82) of patients in the nivolumab plus ipilimumab group and in 27% (16-40) of those in the nivolumab group. Treatment-related adverse events of any grade led to treatment discontinuation in 34 (62%) of 55 patients in the nivolumab plus ipilimumab group and seven (13%) of 56 in the nivolumab group. Three deaths from adverse events were reported but were considered unrelated to the study treatment.
INTERPRETATION


Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease. The rates of grade 3-4 treatment-related adverse events in both active treatment groups were higher than the rates reported in previous pivotal trials done in advanced melanoma with measurable disease.
FUNDING


Bristol-Myers Squibb.",2020,"INTERPRETATION


Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease.","['patients with resected stage IV melanoma with no evidence of disease (IMMUNED', '20 German academic medical centres', 'Between Sept 2, 2015, and Nov 20, 2018, 167 patients', 'patients with stage IV melanoma with no evidence of disease', 'Eligible patients were aged 18-80 years with stage IV melanoma with no evidence of disease after surgery or radiotherapy', 'patients with advanced-ie, unresectable or metastatic-melanoma', 'Eligible patients']","['nivolumab alone or in combination with ipilimumab', 'adjuvant nivolumab plus ipilimumab', 'nivolumab monotherapy group (3 mg/kg of intravenous nivolumab every 2 weeks plus ipilimumab-matching placebo', 'nivolumab plus ipilimumab group (1 mg/kg of intravenous nivolumab every 3 weeks plus 3 mg/kg of intravenous ipilimumab', 'nivolumab', 'nivolumab plus ipilimumab', 'Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus placebo', 'placebo']","['Treatment-related grade 3-4 adverse events', 'rates of grade 3-4 treatment-related adverse events', 'hazard ratio for recurrence', 'safety and efficacy', 'recurrence-free survival', '1-year recurrence-free survival', 'median recurrence-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",167.0,0.766829,"INTERPRETATION


Adjuvant therapy with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significantly compared with placebo in patients with stage IV melanoma with no evidence of disease.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zimmer', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Livingstone', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Hassel', 'Affiliation': 'Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fluck', 'Affiliation': 'Department of Oncology Hornheide, Fachklinik Hornheide, Münster, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eigentler', 'Affiliation': 'Department of Dermatology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Haferkamp', 'Affiliation': 'Department of Dermatology, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center Hannover, Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Friedegund', 'Initials': 'F', 'LastName': 'Meier', 'Affiliation': 'Department of Dermatology, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mohr', 'Affiliation': 'Department of Dermatology, Elbe-Kliniken, Buxtehude, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'Department of Dermatology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Schilling', 'Affiliation': 'Department of Dermatology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Menzer', 'Affiliation': 'Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kieker', 'Affiliation': 'Department of Dermatology, Charité Campus Mitte, Berlin, Germany.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Dippel', 'Affiliation': 'Department of Dermatology, Ludwigshafen Medical Center, Ludwigshafen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rösch', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium (DKTK), University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jan-Christoph', 'Initials': 'JC', 'LastName': 'Simon', 'Affiliation': 'Department of Dermatology, Leipzig University Hospital Medical Center, Leipzig, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Conrad', 'Affiliation': 'Department of Oncology Hornheide, Fachklinik Hornheide, Münster, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Körner', 'Affiliation': 'Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Windemuth-Kieselbach', 'Affiliation': 'Alcedis GmbH, Giessen, Germany.'}, {'ForeName': 'Leonora', 'Initials': 'L', 'LastName': 'Schwarz', 'Affiliation': 'Alcedis GmbH, Giessen, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Jürgen C', 'Initials': 'JC', 'LastName': 'Becker', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany; Translational Skin Cancer Research, German Cancer Consortium (DKTK), Partner Site Essen, Medical Faculty, University of Duisburg-Essen, Essen, Germany; German Cancer Consortium (DKTK), University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium (DKTK), University of Duisburg-Essen, Essen, Germany. Electronic address: dirk.schadendorf@uk-essen.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30417-7']
2115,32419473,Lenvatinib versus sorafenib for unresectable hepatocellular carcinoma: a cost-effectiveness analysis.,"Aim:  To investigate the cost-effectiveness of lenvatinib and sorafenib in the treatment of patients with nonresected hepatocellular carcinoma in China.  Materials & methods:  Markov model was used to simulate the direct medical cost and quality-adjusted life years (QALY) of patients with hepatocellular carcinoma. Clinical data were derived from the Phase 3 randomized clinical trial in a Chinese population.  Results:  Sorafenib treatment resulted in 1.794 QALYs at a cost of $43,780.73. Lenvatinib treatment resulted in 2.916 QALYs for patients weighing <60 and ≥60 kg at a cost of $57,049.43 and $75,900.36, The incremental cost-effectiveness ratio to the sorafenib treatment group was $11,825.94/QALY and $28,627.12/QALY, respectively.  Conclusion:  According to WHO's triple GDP per capita, the use of lenvatinib by providing drugs is a cost-effective strategy.",2020,"Lenvatinib treatment resulted in 2.916 QALYs for patients weighing <60 and ≥60 kg at a cost of $57,049.43 and $75,900.36, The incremental cost-effectiveness ratio to the sorafenib treatment group was $11,825.94/QALY and $28,627.12/QALY, respectively.  ","['unresectable hepatocellular carcinoma', 'patients with nonresected hepatocellular carcinoma in China', 'patients with hepatocellular carcinoma']","['lenvatinib and sorafenib', 'Lenvatinib versus sorafenib', 'Sorafenib']","['incremental cost-effectiveness ratio', 'direct medical cost and quality-adjusted life years (QALY']","[{'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0749662,"Lenvatinib treatment resulted in 2.916 QALYs for patients weighing <60 and ≥60 kg at a cost of $57,049.43 and $75,900.36, The incremental cost-effectiveness ratio to the sorafenib treatment group was $11,825.94/QALY and $28,627.12/QALY, respectively.  ","[{'ForeName': 'Hongfu', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Longfeng', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Fujian Provincial Cancer Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': 'Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Maobai', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.'}]",Journal of comparative effectiveness research,['10.2217/cer-2020-0041']
2116,26924599,"Impact of small-quantity lipid-based nutrient supplement on hemoglobin, iron status and biomarkers of inflammation in pregnant Ghanaian women.","We examined hemoglobin (Hb, g/L), iron status (zinc protoporphyrin, ZPP, µmol/mol heme, and transferrin receptor, TfR, mg/L) and inflammation (C-reactive protein, CRP and alpha-1 glycoprotein, AGP) in pregnant Ghanaian women who participated in a randomized controlled trial. Women (n = 1320) received either 60 mg Fe + 400-µg folic acid (IFA); 18 micronutrients including 20-mg Fe (MMN) or small-quantity lipid-based nutrient supplements (SQ-LNS, 118 kcal/d) with the same micronutrient levels as in MMN, plus four additional minerals (LNS) daily during pregnancy. Intention-to-treat analysis included 349, 354 and 354 women in the IFA, MMN and LNS groups, respectively, with overall baseline mean Hb and anemia (Hb <100) prevalence of 112 and 13.3%, respectively. At 36 gestational weeks, overall Hb was 117, and anemia prevalence was 5.3%. Compared with the IFA group, the LNS and MMN groups had lower mean Hb (120 ± 11 vs. 115 ± 12 and 117 ± 12, respectively; P < 0.001), higher mean ZPP (42 ± 30 vs. 50 ± 29 and 49 ± 30; P = 0.010) and TfR (4.0 ± 1.3 vs. 4.9 ± 1.8 and 4.6 ± 1.7; P < 0.001), and greater prevalence of anemia (2.2% vs. 7.9% and 5.8%; P = 0.019), elevated ZPP (>60) [9.4% vs. 18.6% and 19.2%; P = 0.003] and elevated TfR (>6.0) [9.0% vs. 19.2% and 15.1%; P = 0.004]. CRP and AGP concentrations did not differ among groups. We conclude that among pregnant women in a semi-urban setting in Ghana, supplementation with SQ-LNS or MMN containing 20 mg iron resulted in lower Hb and iron status but had no impact on inflammation, when compared with iron (60 mg) plus folic acid (400 µg). The amount of iron in such supplements that is most effective for improving both maternal Hb/iron status and birth outcomes requires further evaluation. This trial was registered at ClinicalTrials.gov as: NCT00970866.",2017,CRP and AGP concentrations did not differ among groups.,"['pregnant Ghanaian women who participated in a randomized controlled trial', 'pregnant Ghanaian women', 'Women (n\u2009=\u20091320', '349, 354 and 354 women in the IFA, MMN and LNS groups, respectively, with overall baseline mean Hb and anemia (Hb <100) prevalence of 112 and 13.3%, respectively', 'pregnant women in a semi-urban setting in Ghana, supplementation with']","['folic acid', 'IFA', 'SQ-LNS or MMN', '60\u2009mg Fe\u2009+\u2009400-µg folic acid (IFA); 18 micronutrients including 20-mg Fe (MMN) or small-quantity lipid-based nutrient supplements (SQ-LNS, 118\u2009kcal/d) with the same micronutrient levels as in MMN, plus four additional minerals (LNS) daily during pregnancy', 'small-quantity lipid-based nutrient supplement', 'LNS and MMN']","['prevalence of anemia', 'hemoglobin, iron status and biomarkers of inflammation', 'anemia prevalence', 'elevated ZPP', 'CRP and AGP concentrations', 'lower Hb and iron status', 'elevated TfR']","[{'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0337834', 'cui_str': 'Ghanaians (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0029297', 'cui_str': 'alpha 1-Acid Glycoprotein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",,0.36307,CRP and AGP concentrations did not differ among groups.,"[{'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Adu-Afarwuah', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lartey', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Okronipa', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Center for Child Health Research and Department of Pediatrics, University of Tampere School of Medicine and Tampere University Hospital, Finland.'}, {'ForeName': 'Mamane', 'Initials': 'M', 'LastName': 'Zeilani', 'Affiliation': 'Nutriset S.A.S., Malaunay, France.'}, {'ForeName': 'Lacey M', 'Initials': 'LM', 'LastName': 'Baldiviez', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Brietta M', 'Initials': 'BM', 'LastName': 'Oaks', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Vosti', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12262']
2117,32419378,An oral health optimized diet reduces the load of potential cariogenic and periodontal bacterial species in the supragingival oral plaque: A randomized controlled pilot study.,"This study aimed to investigate the effects of an oral health optimized diet on the composition of the supragingival oral plaque in a randomized controlled trial. Participants of the standard diet group (n = 5) had a diet high in processed carbohydrates and did not change their dietary behavior during the observation. The healthy diet group (n = 9) had to change the diet after 2 weeks from a diet high in processed carbohydrates to a diet low in carbohydrates, rich in omega-3 fatty acids, rich in vitamins C and D, antioxidants and fiber for 4 weeks. Saliva and supragingival plaque samples were taken at the end of week two and eight of the observation period to investigate the composition of microbiota in saliva and supragingival plaque. Data were subjected to an exploratory analysis to identify significant differences. Statistically significant differences were only found in the healthy diet group between the baseline (week 2) and the final sample (week 8) for specific species in plaque and saliva samples. A reduction of the total counts of Streptococcus mitis group, Granulicatella adiacens, Actinomyces spp., and Fusobacterium spp. was found in plaque samples of the healthy diet group. In saliva samples of the healthy diet group, the total counts of Actinomyces spp. and Capnocytophaga spp. decreased. A diet low in carbohydrates, rich in omega-3 fatty acids, rich in vitamins C and D, and rich in fiber reduced Streptococcus mitis group, Granulicatella adiacens, Actinomyces spp., and Fusobacterium spp. in the supragingival plaque.",2020,"A reduction of the total counts of Streptococcus mitis group, Granulicatella adiacens, Actinomyces spp., and Fusobacterium spp. was found in plaque samples of the healthy diet group.",[],"['diet high in processed carbohydrates', 'diet high in processed carbohydrates to a diet low in carbohydrates, rich in omega-3 fatty acids, rich in vitamins C and D, antioxidants and fiber for 4\xa0weeks', 'oral health optimized diet']",['total counts of Actinomyces spp'],[],"[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0001250', 'cui_str': 'Actinomyces'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}]",,0.0238515,"A reduction of the total counts of Streptococcus mitis group, Granulicatella adiacens, Actinomyces spp., and Fusobacterium spp. was found in plaque samples of the healthy diet group.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tennert', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Reinmuth', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Bremer', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al-Ahmad', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Lamprini', 'Initials': 'L', 'LastName': 'Karygianni', 'Affiliation': 'Clinic of Preventive Dentistry, Periodontology and Cariology, Center of Dental Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Hellwig', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Vach', 'Affiliation': 'Department of Medical Biometry and Statistics, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Ratka-Krüger', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Wittmer', 'Affiliation': 'Department of Microbiology and Hygiene, Institute of Medical Microbiology and Hygiene, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Johan Peter', 'Initials': 'JP', 'LastName': 'Woelber', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine, Center for Dental Medicine, Medical Center - University of Freiburg, Freiburg im Breisgau, Germany.'}]",MicrobiologyOpen,['10.1002/mbo3.1056']
2118,32419536,"Efficacy and safety of guselkumab compared with placebo and adalimumab in Korean patients with moderate-to-severe psoriasis: Post-hoc analysis from the phase III, double-blind, placebo- and active-comparator-controlled VOYAGE 1/2 trials.","BACKGROUND


The phase 3 studies, VOYAGE 1 and 2, were conducted to assess guselkumab in the treatment of patients with moderate-to-severe psoriasis.
OBJECTIVES


To investigate the efficacy and safety of guselkumab in Korean patients.
METHODS


The Korean sub-population of VOYAGE 1 and 2 study patients were included in this analysis. Efficacy and safety were evaluated through Weeks 24 and 28, respectively.
RESULTS


Of 126 randomized Korean patients, 30, 63, and 33 received placebo, guselkumab, and adalimumab, respectively. At Week 16, guselkumab was superior to placebo in achieving an Investigator's Global Assessment (IGA) score of 0 or 1 (cleared or minimal; 90.5% vs 20.0%, p < 0.001) and a Psoriasis Area and Severity Index (PASI) 90 response (71.4% vs 3.3%, p < 0.001). At Week 24, a significantly higher proportion of guselkumab-treated patients achieved PASI 75 and IGA 0 (clear skin) responses compared to adalimumab-treated patients (PASI 75: 93.7% vs 66.7%, p < 0.001; IGA 0: 52.4% vs 21.2%, p = 0.004). Through Week 28, guselkumab and adalimumab showed comparable safety profiles.
CONCLUSION


The efficacy and safety of guselkumab in Korean psoriasis patients through 28 weeks were consistent with findings for the overall VOYAGE 1 and 2 study population.",2020,"At Week 24, a significantly higher proportion of guselkumab-treated patients achieved PASI 75 and IGA 0 (clear skin) responses compared to adalimumab-treated patients (PASI 75: 93.7% vs 66.7%, p < 0.001; IGA 0: 52.4% vs 21.2%, p = 0.004).","['Korean patients with moderate-to-severe psoriasis', 'Korean psoriasis patients through 28 weeks', '126 randomized Korean patients, 30, 63, and 33 received', 'patients with moderate-to-severe psoriasis', 'Korean patients']","['placebo, guselkumab, and adalimumab', 'guselkumab', 'guselkumab and adalimumab', 'placebo and adalimumab', 'placebo']","[""Investigator's Global Assessment (IGA) score"", 'Psoriasis Area and Severity Index (PASI) 90 response', 'PASI 75 and IGA 0 (clear skin) responses', 'Efficacy and safety', 'efficacy and safety']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",126.0,0.182754,"At Week 24, a significantly higher proportion of guselkumab-treated patients achieved PASI 75 and IGA 0 (clear skin) responses compared to adalimumab-treated patients (PASI 75: 93.7% vs 66.7%, p < 0.001; IGA 0: 52.4% vs 21.2%, p = 0.004).","[{'ForeName': 'Sang Woong', 'Initials': 'SW', 'LastName': 'Youn', 'Affiliation': 'Department of Dermatology, Seoul National University Bundang Hospital and Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Dae Young', 'Initials': 'DY', 'LastName': 'Yu', 'Affiliation': 'Medical Affairs, Janssen Korea, Seoul, Korea.'}, {'ForeName': 'Tae Yoon', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': ""Department of Dermatology, Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Korea.""}, {'ForeName': 'Byung Soo', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Pusan National University School of Medicine, Busan, Korea.'}, {'ForeName': 'Seung Chul', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Chonnam National University Hospital, Gwangju, Korea.'}, {'ForeName': 'Jeung Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Chungnam National University Hospital, Daejeon, Korea.'}, {'ForeName': 'Yong-Beom', 'Initials': 'YB', 'LastName': 'Choe', 'Affiliation': 'Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Joo-Heung', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Jee-Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Joo Young', 'Initials': 'JY', 'LastName': 'Roh', 'Affiliation': 'Department of Dermatology, Gachon University College of Medicine, Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Seong Jin', 'Initials': 'SJ', 'LastName': 'Jo', 'Affiliation': 'Department of Dermatology, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun-So', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Ajou University Hospital, Suwon, Korea.'}, {'ForeName': 'Min Kyung', 'Initials': 'MK', 'LastName': 'Shin', 'Affiliation': 'Department of Dermatology, Kyunghee University Medical Center, Seoul, Korea.'}, {'ForeName': 'Min-Geol', 'Initials': 'MG', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jingzhi', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Janssen Research & Development LLC, Spring House, PA, USA.'}, {'ForeName': 'YoungJa', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Medical Affairs, Janssen Korea, Seoul, Korea.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1770174']
2119,26775711,"In a rural area of Bangladesh, traditional birth attendant training improved early infant feeding practices: a pragmatic cluster randomized trial.","In rural Bangladesh, most births take place at home. There is little evidence regarding the influence of traditional birth attendants (TBAs) or community volunteers (CVs) on early infant feeding practices. We conducted a pragmatic cluster randomized controlled trial in Panchagarh District to examine the effects of training and post-training supervision of TBAs/CVs on early breastfeeding practices. Nine unions were randomized into three groups of three unions. We compared outcomes between mothers in a control group (CG), those living in unions where TBAs/CVs had received a 5-day training in early feeding practices (TG) and those living in unions where TBAs/CVs were both trained and supervised (SG). A total of 1182 mothers of infants aged 0-6 months were interviewed at baseline. After 6 months of intervention, an endline survey was conducted on a different sample of 1148 mothers of infants aged 0-6 months in the same areas. In both intervention areas, TBAs/CVs made regular home visits and attended births whenever possible. Rates of early initiation of breastfeeding, avoidance of prelacteal feeds and exclusive breastfeeding were compared between groups using cluster-controlled mixed model logistic regression. At endline, both intervention groups had significantly higher proportions of mothers who reported early initiation of breastfeeding (CG: 88%, TG: 96%, SG: 96%) and avoidance of prelacteal feeds (CG: 48%, TG: 80%, SG: 88%) compared with the control group; there were no significant differences between the two intervention groups. The endline rates of reported exclusive breastfeeding were not significantly different among groups (CG: 67%, TG: 76%, SG: 83%).",2017,"The endline rates of reported exclusive breastfeeding were not significantly different among groups (CG: 67%, TG: 76%, SG: 83%).","['1182 mothers of infants aged 0-6\u2009months', '1148 mothers of infants aged 0-6\u2009months in the same areas']","['5-day training in early feeding practices (TG) and those living in unions where TBAs/CVs were both trained and supervised (SG', 'training and post-training supervision of TBAs/CVs']","['Rates of early initiation of breastfeeding, avoidance of prelacteal feeds and exclusive breastfeeding', 'avoidance of prelacteal feeds', 'endline rates of reported exclusive breastfeeding', 'early initiation of breastfeeding']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2317036', 'cui_str': 'Initiation of breastfeeding'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",1182.0,0.0855335,"The endline rates of reported exclusive breastfeeding were not significantly different among groups (CG: 67%, TG: 76%, SG: 83%).","[{'ForeName': 'Shamim', 'Initials': 'S', 'LastName': 'Talukder', 'Affiliation': 'Eminence Associates, Dhaka, Bangladesh.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Farhana', 'Affiliation': 'Eminence Associates, Dhaka, Bangladesh.'}, {'ForeName': 'Bineti', 'Initials': 'B', 'LastName': 'Vitta', 'Affiliation': 'Program in International and Community Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Greiner', 'Affiliation': 'formerly Department of Nutrition, Hanyang University, Seoul, Korea.'}]",Maternal & child nutrition,['10.1111/mcn.12237']
2120,26775560,Effect of ready-to-use foods for preventing child undernutrition in Niger: analysis of a prospective intervention study over 15 months of follow-up.,"Strategies for preventing undernutrition comprise a range of interventions, including education, provision of complementary food and cash transfer. Here, we compared monthly distributions of two different lipid-based nutrient supplements (LNS), large-quantity LNS (LNS-LQ) and medium-quantity LNS (LNS-MQ) for 15 months on prevention of undernutrition among children 6 to 23 months. Both groups also received cash transfer for the first 5 months of the intervention. We conducted a prospective intervention study in Maradi, Niger, between August 2011 and October 2012. Six and 11 villages were randomly allocated to LNS-LQ/Cash and LNS-MQ/Cash, respectively. Children measuring 60-80 cm were enrolled in the respective groups and followed up monthly. Poisson regression was used to assess differences between interventions and adjust for baseline characteristics, intervention periods and child-feeding practices. The analysis included 2586 children (1081 in the LNS-LQ/Cash group and 1505 in the LNS-MQ/Cash group). This study suggests that provision of LNS-LQ (reference) or LNS-MQ had, overall, similar effect on incidence of severe acute malnutrition (RR = 0.97; 95% CI: 0.67-1.40; P = 0.88), moderate acute malnutrition (RR = 1.20; 95% CI: 0.97-1.48; P = 0.08), severe stunting (RR = 0.94; 95% CI: 0.70-1.26; P = 0.69), moderate stunting (RR = 0.95; 95% CI: 0.76-1.19; P = 0.67) and mortality (RR = 0.83; 95% CI: 0.41-1.65; P = 0.59). Compared with LNS-LQ, LNS-MQ showed a greater protective effect on moderate acute malnutrition among children with good dietary adequacy: RR = 0.72; 95% CI: 0.56-0.94; P = 0.01. These results highlight the need to design context-specific programmes. Provision of LNS-LQ might be more appropriate when food insecurity is high, while when food security is better, distribution of LNS-MQ might be more appropriate.",2017,"Compared with LNS-LQ, LNS-MQ showed a greater protective effect on moderate acute malnutrition among children with good dietary adequacy: RR = 0.72; 95% CI: 0.56-0.94; P = 0.01.","['children 6 to 23\u2009months', 'Maradi, Niger, between August 2011 and October 2012', 'Children measuring 60-80\u2009cm were enrolled in the respective groups and followed up monthly', 'child undernutrition in Niger', 'Six and 11 villages', '2586 children (1081 in the LNS-LQ/Cash group and 1505 in the LNS-MQ/Cash group']","['LNS-LQ, LNS-MQ', 'ready-to-use foods', 'lipid-based nutrient supplements (LNS), large-quantity LNS (LNS-LQ) and medium-quantity LNS (LNS-MQ', 'LNS-LQ/Cash and LNS-MQ/Cash, respectively']","['severe acute malnutrition', 'mortality', 'severe stunting', 'moderate stunting', 'moderate acute malnutrition']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}]","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}]","[{'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}]",2586.0,0.0596368,"Compared with LNS-LQ, LNS-MQ showed a greater protective effect on moderate acute malnutrition among children with good dietary adequacy: RR = 0.72; 95% CI: 0.56-0.94; P = 0.01.","[{'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Prudhon', 'Affiliation': 'Epicentre, Paris, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Langendorf', 'Affiliation': 'Epicentre, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roederer', 'Affiliation': 'Epicentre, Paris, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Doyon', 'Affiliation': 'Médecins Sans Frontières, Paris, France.'}, {'ForeName': 'Abdoul-Aziz', 'Initials': 'AA', 'LastName': 'Mamaty', 'Affiliation': 'Epicentre, Niamey, Niger.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Woi-Messe', 'Affiliation': 'Epicentre, Niamey, Niger.'}, {'ForeName': 'Mahamane L', 'Initials': 'ML', 'LastName': 'Manzo', 'Affiliation': 'Regional Department of the Ministry of Public Health, Maradi, Niger.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'de Pee', 'Affiliation': 'Nutrition Division, World Food Program, Rome, Italy.'}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Grais', 'Affiliation': 'Epicentre, Paris, France.'}]",Maternal & child nutrition,['10.1111/mcn.12236']
2121,31554075,"Bacillus coagulans GBI-30, 6068 decreases upper respiratory and gastrointestinal tract symptoms in healthy Mexican scholar-aged children by modulating immune-related proteins.","This randomized, double-blind, parallel and placebo-controlled study aimed to evaluate the effect of Bacillus coagulans GBI-30, 6086® probiotic (GanedenBC 30 ®) against upper respiratory tract infections (URTI) and gastrointestinal tract infections (GITI) in eighty healthy school-aged children (6-8 years old). The participants received daily a sachet containing either GanedenBC 30  (1 × 10 9  colony-forming units) or placebo (maltodextrin) for three months. GanedenBC 30  significantly decreased the incidence of URTI symptoms including nasal congestion, bloody nasal mucus, itchy nose, and hoarseness. The duration of the URTI-associated symptoms of hoarseness, headache, red eyes, and fatigue was also decreased. GanedenBC 30  supplementation also significantly reduced the incidence rate of flatulence. These beneficial effects were associated with the modulation of serum TNFα, CD163, G-CSF, ICAM-1, IL-6, IL-8, MCP-2, RAGE, uPAR, and PF4. Therefore, probiotic B. coagulans GBI-30, 6086 modulated immune-related proteins in healthy children, decreasing several URTI and GITI symptoms, thus, this functional ingredient may contribute to a healthier lifestyle.",2019,"These beneficial effects were associated with the modulation of serum TNFα, CD163, G-CSF, ICAM-1, IL-6, IL-8, MCP-2, RAGE, uPAR, and PF4.","['healthy Mexican scholar-aged children', 'eighty healthy school-aged children (6-8\u202fyears old', 'healthy children']","['placebo', 'placebo (maltodextrin', 'Bacillus coagulans GBI-30, 6086® probiotic (GanedenBC 30 ®']","['modulation of serum TNFα, CD163, G-CSF, ICAM-1, IL-6, IL-8, MCP-2, RAGE, uPAR, and PF4', 'duration of the URTI-associated symptoms of hoarseness, headache, red eyes, and fatigue', 'upper respiratory and gastrointestinal tract symptoms', 'incidence rate of flatulence', 'incidence of URTI symptoms including nasal congestion, bloody nasal mucus, itchy nose, and hoarseness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0034634', 'cui_str': 'Rage'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom (finding)'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0235267', 'cui_str': 'Red eye (disorder)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0225392', 'cui_str': 'Nasal mucus (substance)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0028429', 'cui_str': 'Nose'}]",30.0,0.186452,"These beneficial effects were associated with the modulation of serum TNFα, CD163, G-CSF, ICAM-1, IL-6, IL-8, MCP-2, RAGE, uPAR, and PF4.","[{'ForeName': 'Miriam A', 'Initials': 'MA', 'LastName': 'Anaya-Loyola', 'Affiliation': 'Facultad de Ciencias Naturales, Universidad Autónoma de Querétaro, Querétaro 76230, Mexico.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Enciso-Moreno', 'Affiliation': 'Unidad de Investigación Biomédica de Zacatecas, IMSS, Zacatecas 98000, Mexico.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'López-Ramos', 'Affiliation': 'Unidad de Investigación Biomédica de Zacatecas, IMSS, Zacatecas 98000, Mexico.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'García-Marín', 'Affiliation': 'Facultad de Química, Universidad Autónoma de Querétaro, Querétaro 76010, Mexico.'}, {'ForeName': 'María Y', 'Initials': 'MY', 'LastName': 'Orozco Álvarez', 'Affiliation': 'Facultad de Ciencias Naturales, Universidad Autónoma de Querétaro, Querétaro 76230, Mexico.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Vega-García', 'Affiliation': 'Facultad de Ciencias Naturales, Universidad Autónoma de Querétaro, Querétaro 76230, Mexico.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Mosqueda', 'Affiliation': 'Facultad de Ciencias Naturales, Universidad Autónoma de Querétaro, Querétaro 76230, Mexico.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'García-Gutiérrez', 'Affiliation': 'Facultad de Química, Universidad Autónoma de Querétaro, Querétaro 76010, Mexico.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Keller', 'Affiliation': 'Keller Consulting Group, Beachwood, OH, USA.'}, {'ForeName': 'Iza F', 'Initials': 'IF', 'LastName': 'Pérez-Ramírez', 'Affiliation': 'Facultad de Química, Universidad Autónoma de Querétaro, Querétaro 76010, Mexico. Electronic address: iza.perez@uaq.mx.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2019.108567']
2122,30569827,Is the Preschool PATHS Curriculum Effective? A Review.,"The preschool PATHS curriculum was designed as a universal preschool classroom curriculum to improve children's social-emotional learning and reduce problem behaviors.
PURPOSE


This review examined the published outcome studies (n = 5) of the preschool PATHS curriculum examining social-emotional and problem behavior outcome measures.
METHOD


One randomized control trial, two quasi-experimental designs and two pre-experimental designs met the inclusion criteria and were reviewed.
RESULTS


The evidence supporting the preschool PATHS curriculum positively impacting social-emotional competencies is mild to moderate. Evidence supporting the preschool PATHS curriculum as a universal curriculum to reduce problem behavior is sparse and equivocal.
DISCUSSION


Early childhood professionals should implement the preschool PATHS curriculum with the understanding that a child's acquisition of social competencies may not readily equate to a reduction in problem behaviors.",2018,"One randomized control trial, two quasi-experimental designs and two pre-experimental designs met the inclusion criteria and were reviewed.
",[],[],[],[],[],[],2.0,0.0220119,"One randomized control trial, two quasi-experimental designs and two pre-experimental designs met the inclusion criteria and were reviewed.
","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Stanley', 'Affiliation': 'a College of Social Work , Florida State University , Tallahassee , FL , USA.'}]",Journal of evidence-based social work (2019),['10.1080/23761407.2018.1558141']
2123,32419540,Fractional CO 2 -assisted photodynamic therapy improves the clinical outcome and patient's satisfaction in toenail onychomycosis treatment: an intra-patient comparative single-center study.,"Background:  Device-based therapies have been used for onychomycosis patients with intolerance to systemic treatments. Photodynamic therapy (PDT) improves onychomycosis, while fractional carbon dioxide (FrCO 2 ) augments the topical drug delivery. Comparative studies between PDT alone and laser-assisted one are lacking. Objective:  We aimed to evaluate the efficacy of PDT alone versus FrCO 2  -assisted PDT for treatment of onychomycosis. Methods:  Twenty-one patients with bilateral onychomycosis of toenails with nearly the same degree of affection were enrolled in this prospective intra-patient-controlled study. The right affected toenail was treated via PDT alone. The left toenail was treated via a FrCO 2  followed immediately by PDT. The sessions were bimonthly for a total of six sessions. Direct microscopy, fungal cultures, clinical evaluation, onychomycosis severity index scoring, and patient's satisfaction were assessed before and 12 weeks after the last session. Results:  Both treatments reduced significantly the onychomycosis severity index (p < 0.05) without significant difference between them. The improvement in nail appearance and patient's satisfaction were higher in laser-assisted PDT than PDT alone (p < 0.05). Conclusion:  Both treatments effectively reduced the severity of onychomycosis with a high degree of safety and tolerability. Fractional CO 2 -assisted PDT enhanced the clinical outcome via improving the nail appearance and patient's satisfaction.Key Message:Photodynamic therapy has a good success rate in clearing onychomycosis. Addition of fractional CO 2  to photodynamic therapy improves the nail appearance and induces better satisfaction to treatment.",2020,Both treatments reduced significantly the onychomycosis severity index (p < 0.05) without significant difference between them.,"['onychomycosis patients with intolerance to systemic treatments', 'Twenty-one patients with bilateral onychomycosis of toenails with nearly the same degree of affection']","['Photodynamic therapy (PDT', 'Fractional CO 2 -assisted photodynamic therapy', 'photodynamic therapy', 'Photodynamic therapy', 'PDT alone versus FrCO']","['onychomycosis severity index', ""nail appearance and patient's satisfaction"", 'safety and tolerability', 'nail appearance', ""Direct microscopy, fungal cultures, clinical evaluation, onychomycosis severity index scoring, and patient's satisfaction"", 'severity of onychomycosis']","[{'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1274470', 'cui_str': 'Onychomycosis of toenails'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600070', 'cui_str': 'Direct microscopy'}, {'cui': 'C0200954', 'cui_str': 'Mycology culture'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}]",21.0,0.0238875,Both treatments reduced significantly the onychomycosis severity index (p < 0.05) without significant difference between them.,"[{'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Abdallah', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Ain shams university, Cairo, Egypt.'}, {'ForeName': 'Mustafa M', 'Initials': 'MM', 'LastName': 'Abu-Ghali', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Ain shams university, Cairo, Egypt.'}, {'ForeName': 'Mohamed Taha', 'Initials': 'MT', 'LastName': 'El-Sayed', 'Affiliation': 'Department of Microbiology and Immunology, Faculty of Veterinary Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Marwa Y', 'Initials': 'MY', 'LastName': 'Soltan', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Ain shams university, Cairo, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1771252']
2124,32419670,A Pilot RCT of A Body-Oriented Group Therapy For Complex Trauma Survivors: An Adaptation of Sensorimotor Psychotherapy.,"This study is a pilot randomized controlled trial that examined the efficacy of a body-oriented group therapy designed to address chronic fear states in the body due to complex trauma. The Trauma and the Body Group (TBG) is a 20-session group psychotherapy that draws upon the principles and techniques of sensorimotor psychotherapy. Thirty-two women with a history of childhood trauma were randomized to immediate treatment or a waitlist control condition. Assessments were conducted one month prior to treatment, immediately after treatment, and six months post-treatment. Significant improvements were found in body awareness, anxiety, and soothing receptivity when comparing treatment to no treatment. The TBG appears to be a valuable tool for helping clients acquire mindfulness and self soothing skills that they can use to reduce posttraumatic symptoms. This study provides preliminary evidence that the TBG provides complex trauma survivors an opportunity to challenge their avoidance of two prominent trauma-related triggers - their bodies and interpersonal relationships - and in so doing may help survivors develop greater body awareness, increase their capacity for self and relational soothing, and reduce their anxiety symptoms.",2020,"Significant improvements were found in body awareness, anxiety, and soothing receptivity when comparing treatment to no treatment.","['Thirty-two women with a history of childhood trauma', 'Complex Trauma Survivors']","['waitlist control condition', 'TBG']","['body awareness, anxiety, and soothing receptivity']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",32.0,0.0247421,"Significant improvements were found in body awareness, anxiety, and soothing receptivity when comparing treatment to no treatment.","[{'ForeName': 'Catherine C', 'Initials': 'CC', 'LastName': 'Classen', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Hughes', 'Affiliation': ""Women's Mental Health Program, Women's College Hospital, Toronto, Canada.""}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Clark', 'Affiliation': ""Women's Mental Health Program, Women's College Hospital, Toronto, Canada.""}, {'ForeName': 'Bonilyn', 'Initials': 'B', 'LastName': 'Hill Mohammed', 'Affiliation': ""Women's Mental Health Program, Women's College Hospital, Toronto, Canada.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Woods', 'Affiliation': ""Women's Mental Health Program, Women's College Hospital, Toronto, Canada.""}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Beckett', 'Affiliation': ""Women's College Research Institute, Women's College Hospital, Toronto, Canada.""}]",Journal of trauma & dissociation : the official journal of the International Society for the Study of Dissociation (ISSD),['10.1080/15299732.2020.1760173']
2125,32419678,Efficacy of low-dose ketamine infusion in anxious vs nonanxious depression: revisiting the Adjunctive Ketamine Study of Taiwanese Patients with Treatment-Resistant Depression.,"BACKGROUND.


The antidepressant effect of low-dose ketamine infusion on Taiwanese patients with anxious vs nonanxious treatment-resistant depression (ANX-TRD vs NANX-TRD) has remained unknown.
METHODS.


In total, 71 patients with TRD were randomized to three groups. Each group had participants who received saline infusions mixed with 0 (a normal saline infusion), 0.2, and 0.5 mg/kg of ketamine. Participants were followed up for 2 weeks. Anxious depression was defined as major depressive disorder with a total score of 7 or more on the 17-item Hamilton Depression Rating Scale Anxiety-Somatization factor. Generalized estimating equation models were used to investigate the effects of treatment (ketamine vs placebo) and depression type (ANX-TRD vs NANX-TRD) in the reduction of depressive symptoms during the follow-up period.
RESULTS.


Patients with ANX-TRD were less likely to respond to a single low-dose ketamine infusion than those with NANX-TRD. Among patients with NANX-TRD, low-dose ketamine infusion was significantly superior to placebo for reducing depressive symptoms. However, among patients with ANX-TRD, ketamine was not superior to placebo; nonetheless, approximately 30% of the patients responded to ketamine infusion compared to 13% who responded to the placebo.
CONCLUSIONS.


Low-dose ketamine infusion was effective for Taiwanese patients with NANX-TRD but not so effective for those with ANX-TRD. A higher level of anxiety severity accompanying depression was related to greater depression severity. This may confound and reduce the antidepressant effect of ketamine infusion.",2020,"Among patients with NANX-TRD, low-dose ketamine infusion was significantly superior to placebo for reducing depressive symptoms.","['Taiwanese patients with anxious vs nonanxious treatment-resistant depression (ANX-TRD vs NANX-TRD', 'Taiwanese patients with NANX-TRD', '71 patients with TRD', 'Taiwanese Patients with Treatment-Resistant Depression', 'anxious vs nonanxious depression']","['ketamine', 'saline infusions mixed with 0 (a normal saline infusion', 'ketamine vs placebo) and depression type (ANX-TRD vs NANX-TRD', 'low-dose ketamine infusion', 'placebo']","['depressive symptoms', 'Anxious depression', '17-item Hamilton Depression Rating Scale Anxiety-Somatization factor']","[{'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0087050', 'cui_str': 'T-Cell Receptor delta-Chain'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0087050', 'cui_str': 'T-Cell Receptor delta-Chain'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",71.0,0.0535728,"Among patients with NANX-TRD, low-dose ketamine infusion was significantly superior to placebo for reducing depressive symptoms.","[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}]",CNS spectrums,['10.1017/S1092852920001194']
2126,32419594,Stromal Cell-Derived Factor-1 Plasmid Treatment for Patients With Peripheral Artery Disease (STOP-PAD) Trial: Six-Month Results.,"Purpose:  To present the 6-month results of the  S tromal Cell-Derived Factor-1 Plasmid  T reatment f o r  P atients with  P eripheral  A rtery  D isease (STOP-PAD) trial. The trial was an attempt to alter the course of chronic limb-threatening ischemia (CLTI) with a biological agent vs placebo after successful arterial revascularization at or below the knee.  Materials and Methods:  The multicenter, randomized, double-blinded, placebo-controlled, phase 2B STOP-PAD trial ( ClinicalTrials.gov  identifier NCT02544204) randomized 109 patients (mean age 71 years; 68 men) with Rutherford category 5 or 6 CLTI and evidence of persistent impaired forefoot perfusion following recent successful revascularization to 8- (n=34) or 16-mg (n=36) intramuscular injections of a non-viral DNA plasmid-based treatment vs placebo (n=34). The primary efficacy outcome was the 6-month wound healing score evaluated by an independent wound core laboratory; the primary safety endpoint was major adverse limb events (MALE), a composite of major amputation plus clinically-driven target lesion revascularization at 6 months.  Results:  Only one-third of the patients had complete wound healing at 6 months in the placebo (31%), 8-mg injection (33%), and 16-mg injection (33%) groups. In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups). During the 6-month period, 6 patients (6%) died, and 24 patients (23%) had an amputation [only 4 (4%) major].  Conclusion:  Combining revascularization and biological therapy failed to improve outcomes in CLTI at 6 months. STOP-PAD has provided insights for future trials to evaluate biological therapy.",2020,"In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups).","['109 patients (mean age 71 years; 68 men) with Rutherford category 5 or 6 CLTI and evidence of persistent impaired forefoot perfusion following recent successful revascularization to 8- (n=34) or', '16-mg (n=36', 'Patients With Peripheral Artery Disease']","['Stromal Cell-Derived Factor-1 Plasmid Treatment', 'intramuscular injections of a non-viral DNA plasmid-based treatment vs placebo', 'S tromal Cell-Derived Factor-1 Plasmid  T reatment', 'biological agent vs placebo', 'placebo']","['toe-brachial index', '6-month wound healing score evaluated by an independent wound core laboratory; the primary safety endpoint was major adverse limb events (MALE), a composite of major amputation plus clinically-driven target lesion revascularization at 6 months', 'complete wound healing', 'rates of MALE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}]","[{'cui': 'C0218504', 'cui_str': 'CXCL12 Chemokine'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0012939', 'cui_str': 'Viral DNA'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C2116889', 'cui_str': 'Toe brachial index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",109.0,0.510948,"In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups).","[{'ForeName': 'Tarek A', 'Initials': 'TA', 'LastName': 'Hammad', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rundback', 'Affiliation': 'Interventional Institute, Holy Name Medical Center, Teaneck, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bunte', 'Affiliation': ""Saint Luke's Mid America Heart Institute, St Luke's Hospital and University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA.""}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'BayCare Physician Partners, Clearwater, FL, USA.'}, {'ForeName': 'Parag D', 'Initials': 'PD', 'LastName': 'Patel', 'Affiliation': 'BayCare Physician Partners, Clearwater, FL, USA.'}, {'ForeName': 'Saihari', 'Initials': 'S', 'LastName': 'Sadanandan', 'Affiliation': ""St Joseph's Hospital, Tampa, FL, USA.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fitzgerald', 'Affiliation': 'Juventas Therapeutics, Cleveland, OH, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pastore', 'Affiliation': 'Juventas Therapeutics, Cleveland, OH, USA.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kashyap', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Christ Hospital, Cincinnati, OH, USA.'}, {'ForeName': 'Mehdi H', 'Initials': 'MH', 'LastName': 'Shishehbor', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820919951']
2127,31822740,Perceptual vision training in non-sport-specific context: effect on performance skills and cognition in young females.,"Although an increasing interest in vision training for sport performance, whether it may have a transfer to sport-specific skills and whether such transfer could be mediated by cognition remain open issues. To enlighten this point, we tested the effect of 6-weeks sport vision training programmes (requiring generic or volleyball-specific motor actions) in non-sport-specific context compared to a third group performing traditional volleyball training in sport-specific context. Fifty-one female volleyball players were randomly assigned to one of three groups. Before and after training period subjects were tested on accuracy of volleyball-specific skills and cognitive performance (clinical reaction time, executive control, perceptual speed). Accuracy of volleyball-specific skills improved after traditional volleyball training with respect to the vision training groups. Conversely, vision training groups improved cognitive performance (clinical reaction time, executive control and perceptual speed), as compared to traditional volleyball training group. Our results have shown that vision training in non-sport-specific context (both generic or with specific motor actions) improved cognitive performance, but seems to be less effective for improving sport-specific skills. These evidences suggest that environment in which exercises were performed plays a key role to improve perception and action in sport-specific skills, supporting the ecological approach to sport learning.",2019,"Conversely, vision training groups improved cognitive performance (clinical reaction time, executive control and perceptual speed), as compared to traditional volleyball training group.","['young females', 'Fifty-one female volleyball players']","['traditional volleyball training', '6-weeks sport vision training programmes (requiring generic or volleyball-specific motor actions', 'Perceptual vision training', 'vision training']","['accuracy of volleyball-specific skills and cognitive performance (clinical reaction time, executive control, perceptual speed', 'cognitive performance', 'cognitive performance (clinical reaction time, executive control and perceptual speed', 'Accuracy of volleyball-specific skills']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]","[{'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",51.0,0.0113783,"Conversely, vision training groups improved cognitive performance (clinical reaction time, executive control and perceptual speed), as compared to traditional volleyball training group.","[{'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Formenti', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, via Kramer 4/A, 20129, Milano, Italy. damiano.formenti@unimi.it.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Duca', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, via Kramer 4/A, 20129, Milano, Italy.'}, {'ForeName': 'Athos', 'Initials': 'A', 'LastName': 'Trecroci', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, via Kramer 4/A, 20129, Milano, Italy.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Ansaldi', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, via Kramer 4/A, 20129, Milano, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Bonfanti', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, via Kramer 4/A, 20129, Milano, Italy.'}, {'ForeName': 'Giampietro', 'Initials': 'G', 'LastName': 'Alberti', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, via Kramer 4/A, 20129, Milano, Italy.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Iodice', 'Affiliation': 'Institute of Cognitive Sciences and Technologies, National Research Council, Via S. Martino della Battaglia 44, 00185, Rome, Italy.'}]",Scientific reports,['10.1038/s41598-019-55252-1']
2128,32419645,ColdZyme® Mouth Spray reduces duration of upper respiratory tract infection symptoms in endurance athletes under free living conditions.,"Upper respiratory tract infection (URTI) can compromise athlete preparation and performance, so countermeasures are desirable. The aim of this study was to assess the effects of ColdZyme® Mouth Spray (ColdZyme) on self-reported upper respiratory tract infection in competitive endurance athletes under free-living conditions.One hundred and twenty-three endurance-trained, competitive athletes (recruited across 4 sites in England, UK) were randomised to control (no treatment, n = 61) or ColdZyme (n = 62) for a 3-month study period (between December 2017 - February 2018; or December 2018 - April 2019). They recorded daily training and illness symptoms (Jackson common cold questionnaire) during the study period.A total of 130 illness episodes were reported during the study with no difference in incidence between groups (episodes per person: 1.1 ± 0.9 Control, 1.0 ± 0.8 ColdZyme, P = 0.290). Episode duration was significantly shorter in ColdZyme compared to Control: Control 10.4 ± 8.5 days vs ColdZyme 7.7 ± 4.0 days, P = 0.016). Further analysis to compare episodes with poor vs good compliance with ColdZyme instructions for use (IFU) within the ColdZyme group showed a further reduction in duration of URTI when compliance was good (9.3 ± 4.5 days in ColdZyme poor IFU compliance vs 6.9 ± 3.5 days in ColdZyme good IFU compliance, P = 0.040).ColdZyme may be an effective countermeasure to reduce URTI duration, which was significantly lower (by 26-34%) in the ColdZyme treatment group (with no influence on incidence). This may have implications for athlete performance.",2020,"Episode duration was significantly shorter in ColdZyme compared to Control: Control 10.4 ± 8.5 days vs ColdZyme 7.7 ± 4.0 days, P = 0.016).","['endurance athletes under free living conditions', 'One hundred and twenty-three endurance-trained, competitive athletes (recruited across 4 sites in England, UK', 'competitive endurance athletes under free-living conditions']","['ColdZyme® Mouth Spray (ColdZyme', 'control (no treatment, n\u2009=\u200961) or ColdZyme', 'ColdZyme® Mouth Spray']","['daily training and illness symptoms (Jackson common cold questionnaire', 'duration of URTI', 'Episode duration', 'URTI duration']","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0425273', 'cui_str': 'Competitive athlete'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009443', 'cui_str': 'Common cold'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",,0.025327,"Episode duration was significantly shorter in ColdZyme compared to Control: Control 10.4 ± 8.5 days vs ColdZyme 7.7 ± 4.0 days, P = 0.016).","[{'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Davison', 'Affiliation': 'Endurance Research Group, School of Sport & Exercise Sciences, University of Kent, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Perkins', 'Affiliation': 'Endurance Research Group, School of Sport & Exercise Sciences, University of Kent, UK.'}, {'ForeName': 'Arwel W', 'Initials': 'AW', 'LastName': 'Jones', 'Affiliation': 'Lincoln Institute for Health, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Gabriella M', 'Initials': 'GM', 'LastName': 'Swart', 'Affiliation': 'Endurance Research Group, School of Sport & Exercise Sciences, University of Kent, UK.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Jenkins', 'Affiliation': 'Lincoln Institute for Health, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Lincoln Institute for Health, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Dargan', 'Affiliation': 'Endurance Research Group, School of Sport & Exercise Sciences, University of Kent, UK.'}]",European journal of sport science,['10.1080/17461391.2020.1771429']
2129,32419647,Worry as a Mechanism to Motivate Information Seeking about Protective End-of-Life Communication Behaviors.,"Making known one's end-of-life (EOL) care wishes via the processes of advance care planning (ACP) and advance directive (AD) completion is associated with many positive outcomes for patients including lower healthcare costs, greater patient-provider relationship satisfaction, increased quality of life, and more. Despite these benefits, fewer than 30% of patients in the United States engage in ACP or complete ADs. These low numbers are most likely due to several causes, including low self-efficacy and low motivation to engage in the process. Several researchers have examined the persuasive power of using worry to motivate patients to engage in preventive health behaviors. The present study expands upon this body of literature by examining patient intentions to seek information related to ACP and AD after being exposed to stimuli intended to arouse differing levels of worry regarding bad EOL outcomes. Participants ( N  = 804) were randomly assigned to either the high worry, low worry, or control group and asked to complete a questionnaire examining beliefs and information seeking intentions regarding ACP and AD completion. Additionally, to control for participants' level of trait worry, each participant completed the Penn State Worry Questionnaire, which was treated as a covariate in the final analysis. A repeated measures MANCOVA found a statistically significant increase for the worrying conditions on the participants' intention to seek information about ACP and ADs from time 1 to time 2 for those in the worry experimental conditions. However, those in the control group did not show a statistically significant increase. Additionally, exposure to the high worry condition was predictive of engaging in actual information seeking behavior about EOL care. Results of the experiment indicate worry is associated with greater motivation to engage in information seeking about ACP and AD. This study contributes to the literature on worry as a persuasive mechanism to motivate patients to engage in important preventative health behaviors.",2020,A repeated measures MANCOVA found a statistically significant increase for the worrying conditions on the participants' intention to seek information about ACP and ADs from time 1 to time 2 for those in the worry experimental conditions.,['Participants ( N  =\xa0804'],"['high worry, low worry, or control group and asked to complete a questionnaire examining beliefs and information seeking intentions regarding ACP and AD completion']",['Penn State Worry Questionnaire'],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}]","[{'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}]",804.0,0.0240796,A repeated measures MANCOVA found a statistically significant increase for the worrying conditions on the participants' intention to seek information about ACP and ADs from time 1 to time 2 for those in the worry experimental conditions.,"[{'ForeName': 'Christian R', 'Initials': 'CR', 'LastName': 'Seiter', 'Affiliation': 'Department of Communication, George Mason University, Fairfax, Virginia, USA.'}, {'ForeName': 'Nate S', 'Initials': 'NS', 'LastName': 'Brophy', 'Affiliation': 'Department of Communication, George Mason University, Fairfax, Virginia, USA.'}]",Journal of health communication,['10.1080/10810730.2020.1765222']
2130,32419679,"A long-term, open-label study of valbenazine for tardive dyskinesia.","BACKGROUND.


Individuals with tardive dyskinesia (TD) who completed a long-term study (KINECT 3 or KINECT 4) of valbenazine (40 or 80 mg/day, once-daily for up to 48 weeks followed by 4-week washout) were enrolled in a subsequent study (NCT02736955) that was primarily designed to further evaluate the long-term safety of valbenazine.
METHODS.


Participants were initiated at 40 mg/day (following prior valbenazine washout). At week 4, dosing was escalated to 80 mg/day based on tolerability and clinical assessment of TD; reduction to 40 mg/day was allowed for tolerability. The study was planned for 72 weeks or until termination due to commercial availability of valbenazine. Assessments included the Clinical Global Impression of Severity-TD (CGIS-TD), Patient Satisfaction Questionnaire (PSQ), and treatment-emergent adverse events (TEAEs).
RESULTS.


At study termination, 85.7% (138/161) of participants were still active. Four participants had reached week 60, and none reached week 72. The percentage of participants with a CGIS-TD score ≤2 (normal/not ill or borderline ill) increased from study baseline (14.5% [23/159]) to week 48 (64.3% [36/56]). At baseline, 98.8% (158/160) of participants rated their prior valbenazine experience with a PSQ score ≤2 (very satisfied or somewhat satisfied). At week 48, 98.2% (55/56) remained satisfied. Before week 4 (dose escalation), 9.4% of participants had ≥1 TEAE. After week 4, the TEAE incidence was 49.0%. No TEAE occurred in ≥5% of participants during treatment (before or after week 4).
CONCLUSIONS.


Valbenazine was well-tolerated and persistent improvements in TD were found in adults who received once-daily treatment for >1 year.",2020,Valbenazine was well-tolerated and persistent improvements in TD were found in adults who received once-daily treatment for >1 year.,"['Individuals with tardive dyskinesia (TD', 'tardive dyskinesia']","['valbenazine', 'Valbenazine']","['tolerated and persistent improvements in TD', 'TEAE', 'Clinical Global Impression of Severity-TD (CGIS-TD), Patient Satisfaction Questionnaire (PSQ), and treatment-emergent adverse events (TEAEs', 'TEAE incidence', 'CGIS-TD score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0686347', 'cui_str': 'Tardive dyskinesia'}]","[{'cui': 'C4078701', 'cui_str': 'valbenazine'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0686347', 'cui_str': 'Tardive dyskinesia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",4.0,0.0389038,Valbenazine was well-tolerated and persistent improvements in TD were found in adults who received once-daily treatment for >1 year.,"[{'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Lindenmayer', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, New York, USA.'}, {'ForeName': 'Cherian', 'Initials': 'C', 'LastName': 'Verghese', 'Affiliation': 'Keystone Clinical Studies, LLC, Norristown, Pennsylvania, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Marder', 'Affiliation': 'Section of Psychosis, University of California Los Angeles, David Geffen School of Medicine, Los Angeles, California, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Burke', 'Affiliation': 'Department of Biostatistics and Data Management, Neurocrine Biosciences, Inc., San Diego, California, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Jimenez', 'Affiliation': 'Department of Clinical Programs, Neurocrine Biosciences, Inc., San Diego, California, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Siegert', 'Affiliation': 'Department of Medical and Clinical Affairs, Neurocrine Biosciences, Inc., San Diego, California, USA.'}, {'ForeName': 'Grace S', 'Initials': 'GS', 'LastName': 'Liang', 'Affiliation': 'Department of Medical Affairs, Neurocrine Biosciences, Inc., San Diego, California, USA.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': ""O'Brien"", 'Affiliation': 'Neurocrine Biosciences, Inc., San Diego, California, USA.'}]",CNS spectrums,['10.1017/S109285292000108X']
2131,32416690,Combined Analysis of Clinical Data on HGF Gene Therapy to Treat Critical Limb Ischemia in Japan.,"OBJECTIVES


The objective of this combined analysis of data from clinical trials in Japan using naked plasmid DNA encoding hepatocyte growth factor (HGF) was to document the safety and efficacy of intramuscular HGF gene therapy in patients with critical limb ischemia (CLI).
METHODS AND RESULTS


HGF gene transfer was performed in 22 patients with CLI in a single-center open trial at Osaka University; 39 patients in a randomized, placebo-controlled, multi-center phase III trial, 10 patients with Buerger's disease in a multi-center open trial; and 6 patients with CLI in a multi-center open trial using 2 or 3 intramuscular injections of naked HGF plasmid at 2 mg or 4 mg. Resting pain on a visual analogue scale (VAS) and wound healing as primary endpoints were evaluated at 12 weeks after the initial injection. Serious adverse events caused by gene transfer were detected in 7 of 77 patients (9.09%). Of particular importance, only one patient experienced peripheral edema (1.30%), in contrast to those who had undergone treatment with VEGF. At 12 weeks after gene transfer, combined evaluation of VAS and ischemic ulcer size demonstrated a significant improvement in HGF gene therapy group as compared to placebo group (P=0.020). Long-term analysis revealed sustained decrease in the size of ischemic ulcer in HGF gene therapy group. In addition, VAS score over 50 mm at baseline (total 27 patients) demonstrated a tendency (P=0.059), but not significant, to improve VAS score in HGF gene therapy as compared to placebo group.
CONCLUSIONS


The findings indicated that intramuscular injection of naked HGF plasmid tended to improve the resting pain and significantly decreased the size of the ischemic ulcer in the patients with CLI who did not have any alternative therapy such as endovascular treatment (EVT) or bypass graft surgery. An HGF gene therapy product, CollategeneTM , was recently launched with conditional and time-limited approval in Japan to treat ischemic ulcer in patients with CLI. Further clinical trials would provide new therapeutic options for patients with CLI.",2020,"At 12 weeks after gene transfer, combined evaluation of VAS and ischemic ulcer size demonstrated a significant improvement in HGF gene therapy group as compared to placebo group (P=0.020).","['Japan', '22 patients with CLI in a single-center open trial at Osaka University; 39 patients in a randomized', 'patients with critical limb ischemia (CLI', 'patients with CLI', ""10 patients with Buerger's disease in a multi-center open trial; and 6 patients with""]","['HGF Gene Therapy', 'CLI', 'intramuscular HGF gene therapy', 'naked HGF plasmid at 2 mg or 4 mg', 'placebo']","['VAS score', 'size of the ischemic ulcer', 'Resting pain on a visual analogue scale (VAS) and wound healing', 'VAS and ischemic ulcer size', 'resting pain', 'peripheral edema', 'size of ischemic ulcer']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0040021', 'cui_str': 'Thromboangiitis obliterans'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0062534', 'cui_str': 'Scatter Factor'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0424470', 'cui_str': 'Undressed'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0265000', 'cui_str': 'Ulcer of artery'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema'}]",10.0,0.0252449,"At 12 weeks after gene transfer, combined evaluation of VAS and ischemic ulcer size demonstrated a significant improvement in HGF gene therapy group as compared to placebo group (P=0.020).","[{'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Morishita', 'Affiliation': 'Department of Clinical Gene Therapy, Graduate School of Medicine, Osaka University, Suita, Osaka. Japan.'}, {'ForeName': 'Munehisa', 'Initials': 'M', 'LastName': 'Shimamura', 'Affiliation': 'Department of Health Development and Medicine, Graduate School of Medicine, Osaka University, Suita, Osaka. Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takeya', 'Affiliation': 'Department of Geriatric Medicine, Graduate School of Medicine, Osaka University, Suita, Osaka. Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Nakagami', 'Affiliation': 'Department of Health Development and Medicine, Graduate School of Medicine, Osaka University, Suita, Osaka. Japan.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Chujo', 'Affiliation': 'AnGes Inc., Tokyo. Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Ishihama', 'Affiliation': 'AnGes Inc., Tokyo. Japan.'}, {'ForeName': 'Ei', 'Initials': 'E', 'LastName': 'Yamada', 'Affiliation': 'AnGes Inc., Tokyo. Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Department of Geriatric Medicine, Graduate School of Medicine, Osaka University, Suita, Osaka. Japan.'}]",Current gene therapy,['10.2174/1566523220666200516171447']
2132,32419703,Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients.,"Objective


Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
Methods


The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention.
Ethics and dissemination


The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak.",2020,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
","['Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score\u202f≥\u202f55), not working from home, and not receiving current counselling or psychotherapy', '162 participants to intervention groups of 7 to 10 participants each or', 'at-risk scleroderma patients']","['Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities', 'videoconference-based intervention', 'scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program', 'Together (SPIN-CHAT', 'waitlist control', 'videoconference-based program']","['symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction', 'PROMIS Anxiety 4a score immediately post-intervention', 'mental health outcomes', 'symptoms of anxiety']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231401', 'cui_str': 'Mild anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",162.0,0.100017,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction.
","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fortuné', 'Affiliation': 'Ottawa Scleroderma Support Group, Ottawa, Ontario, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Gietzen', 'Affiliation': 'Scleroderma Foundation, Danvers, Massachusetts, USA.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Guillot', 'Affiliation': 'Sclérodermie Québec, Longueuil, Quebec, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lewis', 'Affiliation': 'Toronto, Ontario, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Nielsen', 'Affiliation': 'Scleroderma Society of Ontario, Hamilton, Ontario, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Richard', 'Affiliation': 'Past-president of Scleroderma Canada, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sauvé', 'Affiliation': 'Scleroderma Society of Ontario and Scleroderma Canada, Hamilton, Ontario, Canada.'}, {'ForeName': 'Joep', 'Initials': 'J', 'LastName': 'Welling', 'Affiliation': 'NVLE Dutch Patient Organization for Systemic Autoimmune Diseases, Utrecht, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Baron', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Division of Rheumatology, Geffen School of Medicine, University of California, LA, California, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gottesman', 'Affiliation': 'Scleroderma Foundation, Los Angeles, CA, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Malcarne', 'Affiliation': 'San Diego State University, SD, California, USA.'}, {'ForeName': 'Maureen D', 'Initials': 'MD', 'LastName': 'Mayes', 'Affiliation': 'University of Texas McGovern School of Medicine, Houston, TX, USA.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Mouthon', 'Affiliation': 'Université Paris Descartes, Paris, France.'}, {'ForeName': 'Warren R', 'Initials': 'WR', 'LastName': 'Nielson', 'Affiliation': ""St. Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Riggs', 'Affiliation': 'Scleroderma Foundation, Danvers, Massachusetts, USA.'}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Wigley', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Assassi', 'Affiliation': 'University of Texas McGovern School of Medicine, Houston, TX, USA.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutron', 'Affiliation': 'Université Paris Descartes, Assistance Publique - Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Ells', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'van den Ende', 'Affiliation': 'Sint Maartenskliniek, Nijmegen, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Fligelstone', 'Affiliation': ""Scleroderma & Raynaud's UK, London, UK.""}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Frech', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Godard', 'Affiliation': 'Association des Sclérodermiques de France, Sorel-Moussel, France.'}, {'ForeName': 'Daphna', 'Initials': 'D', 'LastName': 'Harel', 'Affiliation': 'New York University, NY, New York, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Hinchcliff', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hudson', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Sindhu R', 'Initials': 'SR', 'LastName': 'Johnson', 'Affiliation': 'Toronto Scleroderma Program, Mount Sinai Hospital, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Larche', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Leite', 'Affiliation': 'University of Minho, Braga, Portugal.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': 'Université Paris Descartes, Assistance Publique - Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Pope', 'Affiliation': 'University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Portales', 'Affiliation': 'Asociación Española de Esclerodermia, Madrid, Spain.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Rannou', 'Affiliation': 'Université Paris Descartes, Assistance Publique - Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Tatiana Sofia Rodriguez', 'Initials': 'TSR', 'LastName': 'Reyna', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Anne A', 'Initials': 'AA', 'LastName': 'Schouffoer', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Suarez-Almazor', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Agard', 'Affiliation': 'Centre Hospitalier Universitaire - Hôtel-Dieu de Nantes, Nantes, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Albert', 'Affiliation': 'Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'André', 'Affiliation': 'Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Guylaine', 'Initials': 'G', 'LastName': 'Arsenault', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Ilham', 'Initials': 'I', 'LastName': 'Benzidia', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpital St-Louis, Paris, France.'}, {'ForeName': 'Elana J', 'Initials': 'EJ', 'LastName': 'Bernstein', 'Affiliation': 'Columbia University, NY, New York, USA.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Berthier', 'Affiliation': 'Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, France.'}, {'ForeName': 'Lyne', 'Initials': 'L', 'LastName': 'Bissonnette', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Boire', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bruns', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Carreira', 'Affiliation': 'Servicio de Reumatologia del Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Casadevall', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Chaigne', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Lorinda', 'Initials': 'L', 'LastName': 'Chung', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Cohen', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Chase', 'Initials': 'C', 'LastName': 'Correia', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Dagenais', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Denton', 'Affiliation': 'Royal Free London Hospital, London, UK.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Domsic', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Dubois', 'Affiliation': 'Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'James V', 'Initials': 'JV', 'LastName': 'Dunne', 'Affiliation': ""St. Paul's Hospital and University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Dunogue', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Fare', 'Affiliation': 'Servicio de Reumatologia del Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Farge-Bancel', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpital St-Louis, Paris, France.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Fortin', 'Affiliation': 'CHU de Québec - Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gill', 'Affiliation': 'Royal Free London Hospital, London, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gordon', 'Affiliation': 'Hospital for Special Surgery, New York City, NY, USA.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Granel-Rey', 'Affiliation': 'Aix Marseille Université, Assistance Publique - Hôpitaux de Marseille, Hôpital Nord, Marseille, France.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Gyger', 'Affiliation': 'Jewish General Hospital, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hachulla', 'Affiliation': 'Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Hatron', 'Affiliation': 'Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'Ariane L', 'Initials': 'AL', 'LastName': 'Herrick', 'Affiliation': 'University of Manchester, Salford Royal NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hij', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpital St-Louis, Paris, France.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Hoa', 'Affiliation': ""Centre hospitalier de l'université de Montréal - CHUM, Montreal, Quebec, Canada.""}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Ikic', 'Affiliation': 'Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Jones', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Artur Jose de B', 'Initials': 'AJB', 'LastName': 'Fernandes', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Kafaja', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Khalidi', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lambert', 'Affiliation': 'Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Launay', 'Affiliation': 'Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Liang', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Maillard', 'Affiliation': 'Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Maltez', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Manning', 'Affiliation': 'Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Marie', 'Affiliation': 'CHU Rouen, Hôpital de Bois-Guillaume, Rouen, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Servicio de Reumatologia del Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Martin', 'Affiliation': 'Les Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Masetto', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maurier', 'Affiliation': 'Hôpitaux Privés de Metz, Hôpital Belle-Isle, Metz, France.'}, {'ForeName': 'Arsene', 'Initials': 'A', 'LastName': 'Mekinian', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpital St-Antoine, Paris, France.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Melchor', 'Affiliation': 'Servicio de Reumatologia del Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Nikpour', 'Affiliation': ""St Vincent's Hospital, University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Olagne', 'Affiliation': 'Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Poindron', 'Affiliation': 'Les Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Proudman', 'Affiliation': 'Royal Adelaide Hospital, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Régent', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Rivière', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpital St-Antoine, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Robinson', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Rodriguez', 'Affiliation': 'Servicio de Reumatologia del Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Roux', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Smets', 'Affiliation': 'Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Sobanski', 'Affiliation': 'Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'Hospital for Special Surgery, New York City, NY, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Steen', 'Affiliation': 'Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stevens', 'Affiliation': ""St Vincent's Hospital, University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Sutton', 'Affiliation': 'Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Terrier', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Thorne', 'Affiliation': 'Southlake Regional Health Centre, Newmarket, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Varga', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Pearce', 'Initials': 'P', 'LastName': 'Wilcox', 'Affiliation': ""St. Paul's Hospital and University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Mara Cañedo', 'Initials': 'MC', 'LastName': 'Ayala', 'Affiliation': 'Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Ostbo', 'Affiliation': 'Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kwakkenbos', 'Affiliation': 'Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Carrier', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Bourgeault', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Harb', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gagarine', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Rice', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bustamante', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ellis', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Delaney', 'Initials': 'D', 'LastName': 'Duchek', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Parash Mani', 'Initials': 'PM', 'LastName': 'Bhandari', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Neupane', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carboni-Jiménez', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Henry', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Levis', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Turner', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Culos-Reed', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'El-Baalbaki', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hebblethwaite', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': 'Department of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dyas', 'Affiliation': 'Scleroderma Foundation Michigan Chapter, Southfield, MI, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Varga', 'Affiliation': 'Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110132']
2133,30792364,Stepped care programme in primary care to prevent anxiety and depression: a randomised clinical trial.,,2019,,[],['Stepped care programme'],['anxiety and depression'],[],"[{'cui': 'C1261552', 'cui_str': 'Step'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.108604,,"[{'ForeName': 'S Y S', 'Initials': 'SYS', 'LastName': 'Wong', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong.'}, {'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Tang', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'W W S', 'Initials': 'WWS', 'LastName': 'Mak', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong.'}, {'ForeName': 'F M C', 'Initials': 'FMC', 'LastName': 'Cheung', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mercer', 'Affiliation': 'General Practice and Primary Care, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Griffiths', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'D T F', 'Initials': 'DTF', 'LastName': 'Lee', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kung', 'Affiliation': 'The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Lam', 'Affiliation': 'New Territories East Cluster, Hospital Authority, Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[]
2134,32419831,Efficacy of Pleuran ( β -Glucan from  Pleurotus ostreatus ) in the Management of Herpes Simplex Virus Type 1 Infection.,"One of the highly prevalent viral pathogens among children and adults causing infection, clinically presenting as herpes labialis, is herpes simplex virus type 1 (HSV-1). The long-term administration of acyclovir, a standard regimen for therapy against HSV-1 infections, can cause viral resistance against this drug. Therefore, the development of natural drugs with low toxicity that are able to enhance host antiviral defense against HSV infection is needed.  β -Glucans represent a type of biologically active molecules possessing antiviral properties. The goal of this study was to investigate the clinical and immunomodulatory effect of  β -glucan pleuran (insoluble  β -1,3/1,6-D-glucan isolated from  Pleurotus ostreatus ) based supplements on the duration and intensity of herpes symptoms and on the incidence rate and duration of acute respiratory symptoms and intercurrent diseases in HSV-1 positive patients. Ninety patients were randomised into active and placebo groups. Active treatment with pleuran in systemic application caused a significantly shorter duration of herpes simplex symptoms compared to the placebo group. During the preventive phase (120 days), the duration and severity of respiratory symptoms were lower in the active group compared to the placebo group; however, a significant difference was found only in the case of cough. No significant side effects were observed during both phases of the clinical trial (acute and preventive). Obtained results suggest that the use of pleuran seems to be a promising approach in the treatment of acute HSV-1 with beneficial effect on the respiratory tract symptoms and infections.",2020,"During the preventive phase (120 days), the duration and severity of respiratory symptoms were lower in the active group compared to the placebo group; however, a significant difference was found only in the case of cough.","['Ninety patients', 'isolated from  Pleurotus ostreatus ', 'Herpes Simplex Virus Type 1 Infection', 'HSV-1 positive patients']","['glucan pleuran (insoluble  β -1,3/1,6-D-glucan', 'acyclovir', 'β', 'Pleuran ( β -Glucan', 'placebo']","['incidence rate and duration of acute respiratory symptoms and intercurrent diseases', 'case of cough', 'duration and severity of respiratory symptoms', 'shorter duration of herpes simplex symptoms', 'duration and intensity of herpes symptoms', 'side effects']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0319683', 'cui_str': 'Pleurotus ostreatus'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0449572', 'cui_str': 'Virus type'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}, {'cui': 'C0219900', 'cui_str': 'polyglucosan'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0277557', 'cui_str': 'Intercurrent disease'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",90.0,0.181291,"During the preventive phase (120 days), the duration and severity of respiratory symptoms were lower in the active group compared to the placebo group; however, a significant difference was found only in the case of cough.","[{'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Urbancikova', 'Affiliation': 'Department of Pediatrics, P. J. Safarik University, Faculty of Medicine, Children Faculty Hospital, Trieda SNP 1, 040 11 Kosice, Slovakia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Hudackova', 'Affiliation': 'Department of Pediatric Infectology, Children Faculty Hospital, Faculty of Medicine, Trieda SNP 1, 040 11 Kosice, Slovakia.'}, {'ForeName': 'Juraj', 'Initials': 'J', 'LastName': 'Majtan', 'Affiliation': 'Institute of Molecular Biology, Slovak Academy of Sciences, Dubravska Cesta 21, 845 51 Bratislava, Slovakia.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Rennerova', 'Affiliation': 'Pneumo-Allergo Centre Ltd., Udernicka 1, 851 01 Bratislava, Slovakia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Banovcin', 'Affiliation': 'Department of Paediatrics, Jessenius Faculty of Medicine, Comenius University in Bratislava, Kollarova 2, 036 59 Martin, Slovakia.'}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Jesenak', 'Affiliation': 'Department of Paediatrics, Jessenius Faculty of Medicine, Comenius University in Bratislava, Kollarova 2, 036 59 Martin, Slovakia.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/8562309']
2135,32419949,Evaluating a combined bowel preparation for small-bowel capsule endoscopy: a prospective randomized-controlled study.,"Background


Capsule endoscopy (CE) is frequently hindered by intra-luminal debris. Our aim was to determine whether a combination bowel preparation would improve small-bowel visualization, diagnostic yield, and the completion rate of CE.
Methods


Single-blind, prospective randomized-controlled study of outpatients scheduled for CE. Bowel-preparation subjects ingested 2 L of polyethylene glycol solution the night prior to CE, 5 mL simethicone and 5 mg metoclopramide 20 minutes prior to CE and laid in the right lateral position 30 minutes after swallowing CE. Controls had no solid food after 7 p.m. the night prior to CE and no liquids 4 hours prior to CE. Participants completed a satisfaction survey. Capsule readers completed a small-bowel-visualization assessment.
Results


Fifty patients were prospectively enrolled (56% female) with a median age of 54.4 years and 44 completed the study (23 patients in the control group and 21 in the preparation group). There was no significant difference between groups on quartile-based small-bowel visualization (all  P  >   0.05). There was no significant difference between groups in diagnostic yield ( P  =   0.69), mean gastric ( P  =   0.10) or small-bowel transit time ( P  =   0.89). The small-bowel completion rate was significantly higher in the preparation group (100% vs 78%;  P  =   0.02). Bowel-preparation subjects reported significantly more discomfort than controls (62% vs 17%;  P  =   0.01).
Conclusions


Combined bowel preparation did not improve small-bowel visualization but did significantly increase patient discomfort. The CE completion rate improved in the preparation group but the diagnostic yield was unaffected. Based on our findings, a bowel preparation prior to CE does not appear to improve CE performance and results in decreased patient satisfaction (ClinicalTrials.gov, No. NCT01243736).",2020,"Bowel-preparation subjects reported significantly more discomfort than controls (62% vs 17%;  P  =   0.01).
","['Fifty patients were prospectively enrolled (56% female) with a median age of 54.4\u2009years and 44 completed the study (23 patients in the control group and 21 in the preparation group', 'outpatients scheduled for CE', 'small-bowel capsule endoscopy']","['metoclopramide', 'polyethylene glycol solution', '\n\n\nCapsule endoscopy (CE']","['small-bowel transit time', 'small-bowel completion rate', 'small-bowel visualization', 'quartile-based small-bowel visualization', 'diagnostic yield', 'patient discomfort', 'CE performance', 'CE completion rate', 'discomfort', 'mean gastric']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C4285996', 'cui_str': 'Small bowel capsule endoscopy'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}]","[{'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}]",50.0,0.0833449,"Bowel-preparation subjects reported significantly more discomfort than controls (62% vs 17%;  P  =   0.01).
","[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Hansel', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Murray', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Alexander', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Bruining', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Larson', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Mangan', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Dierkhising', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Almazar', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rajan', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}]",Gastroenterology report,['10.1093/gastro/goz054']
2136,32419688,Dietary intake and processes of behaviour change in a nutrition education intervention for pregnant women in rural Malawi: a cluster-randomised controlled trial.,"OBJECTIVE


To examine if increased intake of locally available nutrient-dense foods among pregnant women improved the quality of their dietary intake and if use of the Theory of Planned Behaviour could explain changes in their dietary behaviour.
DESIGN


We used data from a randomised controlled trial where the intervention group received nutrition education and dietary counselling. We promoted the use of recipes that utilised powders to enhance dietary diversity. We examined how the intervention achieved changes in dietary intakes and used mixed effects logistic regression models with random effects at village level to explore changes over time of the outcomes, adjusted for selected explanatory variables.
SETTING


The study was conducted in twenty villages in rural Malawi.
PARTICIPANTS


Data from 257 pregnant women who were enrolled during late first trimester and followed until birth.
RESULTS


The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods. A third of the women in the intervention group attained optimal DDS, whereas about 50 % attained optimal SFG. The theorised behaviour mediators (i.e. nutrition attitudes, nutrition behaviour control and subjective norm) that had improved were also significantly associated with high DDS.
CONCLUSIONS


Improved dietary intakes were achieved through promoting the use of locally available nutrient-dense foods. Attainment of high DDS was a consequence of the women's belief in the effectiveness of the proposed nutrition recommendations. We identified critical personal and environmental constraints related to dietary intakes during pregnancy in a low-resource setting.",2020,"The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods.","['twenty villages in rural Malawi', 'Data from 257 pregnant women who were enrolled during late first trimester and followed until birth', 'pregnant women in rural Malawi', 'pregnant women']","['nutrition education and dietary counselling', 'nutrition education intervention']","['Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods', 'optimal DDS']","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0453861', 'cui_str': 'Rich food'}]",257.0,0.0758828,"The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods.","[{'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Ziyenda Katenga-Kaunda', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}, {'ForeName': 'Per Ole', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Holmboe-Ottesen', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Fjeld', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ibrahimu', 'Initials': 'I', 'LastName': 'Mdala', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Penjani Rhoda', 'Initials': 'PR', 'LastName': 'Kamudoni', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}]",Public health nutrition,['10.1017/S1368980020000294']
2137,32419808,Therapeutic Effect of  Abelmoschus manihot  on Type 2 Diabetic Nonproliferative Retinopathy and the Involvement of VEGF.,"Objective


To evaluate the efficacy of  Abelmoschus manihot  in treating type 2 diabetic nonproliferative retinopathy.
Methods


It was a randomized controlled clinical trial. The recruited eighty subjects with type 2 diabetic nonproliferative retinopathy were randomly divided into treatment group and control group. The two groups received basic treatments including control of blood glucose, blood pressure and blood lipid, management of diet, exercise and health education, and monitoring of relevant indicators. Additionally, the treatment group was given oral administration of  Abelmoschus manihot . All subjects were followed up on monthly basis for consecutive six months. The related parameters including diabetic retinopathy (DR) incidence rates, ""Early Treatment Diabetic Retinopathy Study"" (ETDRS) vision scores, retinal thicknesses in macular region, serum vascular endothelial growth factor (VEGF) levels, and biochemical indicators of both groups before and after treatment were accurately collected and statistically analyzed.
Results


There were no significant differences of DR severity levels, ETDRS vision scores, macular retinal thicknesses such as cube average thickness (CAT), central subfield thickness (CST), and cube volume (CV), and serum VEGF levels between two groups before treatment. Meanwhile, there were no significant differences of demographic characteristics, case terminations, blood glucose, blood lipid, blood pressure, biochemical indicators of hepatorenal function, hypoglycemic drugs, hypotensive drugs, and other basic treatments between two groups during six months treatment. The present study suggested that the remission rate of DR and the ETDRS vision score in the treatment group were significantly higher than those of the control group (remission rate: 25.4% vs 9.3%,  P =0.01; ETDRS score: 78 (72, 82) vs 72 (67, 80),  P =0.0002) while the progression rate of DR in the treatment group was significantly lower than that of the control group (progression rate: 4.2% vs 18.7%,  P =0.007) after six months treatment. In addition, the CAT, CST, CV, and serum VEGF levels of the treatment group were significantly improved after the treatment (CAT: 286 (278, 302) vs 282 (270, 295)  μ m,  P  < 0.0001; CST: 251 (239, 274) vs 248 (235, 265)  μ m,  P  < 0.0001; CV: 10.3 (10.0, 10.9) vs 10.1 (9.7, 10.6) mm 3 ,  P  < 0.0001; VEGF: 0.21 (0.14, 0.58) vs 0.16 (0.10, 0.23) ng/ml,  P =0.0026), while there were no significant differences of the control group before and after treatment (CAT: 287 (279, 294) vs 287 (279, 295)  μ m,  P =0.27; CST: 250 (240, 266) vs 252 (238, 266)  μ m,  P =0.72; CV: 10.4 (10.1, 10.6) vs 10.4 (10.1, 10.7) mm 3 ,  P =0.53; VEGF: 0.21 (0.13, 0.66) vs 0.23 (0.12, 0.64) ng/ml,  P =0.85).
Conclusion


The study offered the novel evidence for the therapeutic effect of  Abelmoschus manihot  on type 2 diabetic nonproliferative retinopathy, which was associated with improved VEGF. This trial is registered with ChiCTR1800019292.",2020,"There were no significant differences of DR severity levels, ETDRS vision scores, macular retinal thicknesses such as cube average thickness (CAT), central subfield thickness (CST), and cube volume (CV), and serum VEGF levels between two groups before treatment.",['recruited eighty subjects with type 2 diabetic nonproliferative retinopathy'],"['basic treatments including control of blood glucose, blood pressure and blood lipid, management of diet, exercise and health education, and monitoring of relevant indicators']","['progression rate of DR', 'CAT, CST, CV, and serum VEGF levels', 'remission rate of DR and the ETDRS vision score', 'demographic characteristics, case terminations, blood glucose, blood lipid, blood pressure, biochemical indicators of hepatorenal function, hypoglycemic drugs, hypotensive drugs, and other basic treatments', 'DR severity levels, ETDRS vision scores, macular retinal thicknesses such as cube average thickness (CAT), central subfield thickness (CST), and cube volume (CV), and serum VEGF levels', 'diabetic retinopathy (DR) incidence rates, ""Early Treatment Diabetic Retinopathy Study"" (ETDRS) vision scores, retinal thicknesses in macular region, serum vascular endothelial growth factor (VEGF) levels, and biochemical indicators']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",80.0,0.0372678,"There were no significant differences of DR severity levels, ETDRS vision scores, macular retinal thicknesses such as cube average thickness (CAT), central subfield thickness (CST), and cube volume (CV), and serum VEGF levels between two groups before treatment.","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Boyu', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Weilong', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Ophthalmology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Qingzi', 'Initials': 'Q', 'LastName': 'Jin', 'Affiliation': 'Department of Ophthalmology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Laboratory, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Jianjiang', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Department of Laboratory, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Jiangyi', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'An', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/5204917']
2138,32065967,Impact of Chlorhexidine Bathing on Antimicrobial Utilization in Surgical Intensive Care Unit.,"BACKGROUND


This secondary analysis compared antimicrobial utilization among surgical intensive care unit patients randomized to every other day chlorhexidine bathing (chlorhexidine) versus daily soap and water bathing (soap-and-water) using data from the CHlorhexidine Gluconate BATHing trial.
MATERIALS AND METHODS


Antimicrobial utilization was quantified using defined daily dose (DDD)/100 patient-days and agent-days/100 patient-days for systemic antimicrobials. Antivirals (except oseltamivir), antiparasitics, and prophylaxis agents were excluded. The 2018 anatomic therapeutic chemical/DDD index was used to calculate DDD. Agent-days were calculated as the sum of calendar days where antimicrobials were administered. Patient-days were defined as time patients were at risk for health care-acquired infections plus up to 14 d. Primary analyses were conducted using linear regression adjusted for baseline Acute Physiology and Chronic Health Evaluation II scores.
RESULTS


Of 325 CHlorhexidine Gluconate BATHing trial patients, 312 (157 in soap-and-water and 155 in chlorhexidine) were included. The median (interquartile range) of total antimicrobial DDD/100 patient-days was 135.4 (75.2-231.8) for soap-and-water and 129.9 (49.2-215.3) for chlorhexidine. The median (interquartile range) of total antimicrobial agent-days/100 patient-days was 155.6 (83.3-243.2) for soap-and-water and 146.7 (66.7-217.4) for chlorhexidine. After adjusting for Acute Physiology and Chronic Health Evaluation II scores, chlorhexidine bathing was associated with a nonsignificant reduction in total antimicrobial DDD/100 patient-days (-3.9; 95% confidence interval, -33.9 to 26.1; P = 0.80) and total antimicrobial agent-days/100 patient-days (-10.3; 95% confidence interval, -34.7 to 14.1; P = 0.41).
CONCLUSIONS


Compared with daily soap and water bathing, every other day chlorhexidine bathing did not significantly reduce total antimicrobial utilization in surgical intensive care unit patients.",2020,"Compared with daily soap and water bathing, every other day chlorhexidine bathing did not significantly reduce total antimicrobial utilization in surgical intensive care unit patients.","['surgical intensive care unit patients', 'Surgical Intensive Care Unit', 'trial patients, 312 (157 in soap-and-water and 155 in']","['chlorhexidine', 'chlorhexidine bathing (chlorhexidine', 'CHlorhexidine Gluconate', 'Chlorhexidine']","['Antimicrobial utilization', 'total antimicrobial utilization']","[{'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0518460', 'cui_str': 'Bathing (observable entity)'}, {'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}]","[{'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0951131,"Compared with daily soap and water bathing, every other day chlorhexidine bathing did not significantly reduce total antimicrobial utilization in surgical intensive care unit patients.","[{'ForeName': 'Lan N', 'Initials': 'LN', 'LastName': 'Bui', 'Affiliation': 'Department of Pharmacy Practice, Samford University McWhorter School of Pharmacy, Birmingham, Alabama; Houston Methodist Research Institute, Houston, Texas.'}, {'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Swan', 'Affiliation': 'Houston Methodist Research Institute, Houston, Texas; Department of Pharmacy Services, Houston Methodist Hospital, Houston, Texas; Department of Surgery, Houston Methodist Hospital, Houston, Texas. Electronic address: swan.joshua@gmail.com.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Perez', 'Affiliation': 'Houston Methodist Research Institute, Houston, Texas; Department of Pharmacy Services, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'Department of Pharmaceutical Health Outcomes and Policy, University of Houston College of Pharmacy, Houston, Texas.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmaceutical Health Outcomes and Policy, University of Houston College of Pharmacy, Houston, Texas.'}, {'ForeName': 'A Carmine', 'Initials': 'AC', 'LastName': 'Colavecchia', 'Affiliation': 'Department of Pharmacy Services, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Elsie', 'Initials': 'E', 'LastName': 'Rizk', 'Affiliation': 'Houston Methodist Research Institute, Houston, Texas.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Graviss', 'Affiliation': 'Houston Methodist Research Institute, Houston, Texas.'}]",The Journal of surgical research,['10.1016/j.jss.2019.12.049']
2139,32420223,Analysis of the rates of emulsification in intraocular silicone oil tamponades of differing viscosities.,"AIM


To investigate the rates of emulsification in silicone oil (SO) tamponades of differing viscosities used during pars plana vitrectomy (PPV) in the treatment of complicated vitreoretinal diseases.
METHODS


This study was a prospective randomized clinical trial. Totally 290 cases with greater likelihoods of secondary detachment were included and randomly grouped into either Siluron 2000 ( n =143) or Siluron 5000 ( n =147) SO tamponades with 23-gauge PPV. Patient follow-ups and data analyses were conducted 1, 3, 6, and 12mo post-surgery.
RESULTS


The time of the SO emulsification ranged from 1 to 17mo, with a mean of 7.3±4.2mo. The Siluron 5000 group showed a slower emulsification rate in comparison to the Siluron 2000 group. The Siluron 2000 group took a shorter time to show signs of emulsification, necessitating earlier SO removal. However, there were no significant differences in the occurrence of complications, including secondary retinal detachment, cataract, corneal abnormality, high intraocular pressure and hypotony.
CONCLUSION


The Siluron 2000 SO tamponade shows a faster rate of emulsification than the Siluron 5000 SO, necessitating earlier removal. Both groups show similar results in terms of anatomical success and visual acuity outcome, and there is no significant difference between the SOs regarding the occurrence of complications.",2020,"Both groups show similar results in terms of anatomical success and visual acuity outcome, and there is no significant difference between the SOs regarding the occurrence of complications.",['Totally 290 cases with greater likelihoods of secondary detachment were included and randomly grouped into either Siluron 2000 ( n =143) or Siluron 5000 ( n =147'],"['pars plana vitrectomy (PPV', '23-gauge PPV', 'silicone oil (SO']","['anatomical success and visual acuity outcome', 'shorter time to show signs of emulsification, necessitating earlier SO removal', 'occurrence of complications, including secondary retinal detachment, cataract, corneal abnormality, high intraocular pressure and hypotony', 'slower emulsification rate']","[{'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C4319610', 'cui_str': '5000'}]","[{'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}]","[{'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0221105', 'cui_str': 'Emulsification'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0035305', 'cui_str': 'Retinal detachment'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0439834', 'cui_str': 'Slow'}]",290.0,0.0553415,"Both groups show similar results in terms of anatomical success and visual acuity outcome, and there is no significant difference between the SOs regarding the occurrence of complications.","[{'ForeName': 'Xiu-Juan', 'Initials': 'XJ', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, Guangdong Province, China.'}, {'ForeName': 'Ning-Ning', 'Initials': 'NN', 'LastName': 'Tang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, Guangdong Province, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lian', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, Guangdong Province, China.'}, {'ForeName': 'Bing-Qian', 'Initials': 'BQ', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, Guangdong Province, China.'}, {'ForeName': 'Yong-Hao', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, Guangdong Province, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, Guangdong Province, China.'}]",International journal of ophthalmology,['10.18240/ijo.2020.05.10']
2140,32419817,Comparing the Effect of Foot Massage with Grape Seed Oil and Sweet Almond Oil on Physiological Leg Edema in Primigravidae: A Randomized Clinical Trial.,"Background


Leg edema is a prevalent problem in pregnancy causing activity restrictions for pregnant women. This study was performed to compare the effect of foot massage using grape seed oil and sweet almond oil on physiological leg edema.
Methods


A randomized clinical trial was conducted on 90 primigravidae referred to public health centres of Zahedan, Iran. The participants' gestational age was 30-40 weeks. The study was conducted from August 2016 to November 2017. The participants were randomly assigned to three groups (massage with grape seed oil, massage with sweet almond oil, and without intervention). After determining the extent of leg edema, foot massages were done for 20 minutes within 5 days in the two intervention groups. Then, foot circumferences were measured on day 5 after the intervention. Foot circumferences for the control group were measured on days 1 and 5. A nonelastic tape measure was used to measure the circumferences. To analyse the data, SPSS 21 software and statistical tests including one-way ANOVA, Tukey's test, and paired  t -test were used.
Results


The results from this study showed a significant difference in the mean score change of foot circumferences between groups ( P =0.001). According to the results of Tukey's test, mean score changes of foot circumferences of both intervention groups were significantly different those of the control group. However, this difference was not significant between the two intervention groups ( P =0.865).
Conclusion


The findings of this study confirmed the effectiveness of foot massage using grape seed and sweet almond oils to reduce pregnancy physiological edema. Therefore, foot massage with appropriate oils can be used as a useful technique by trained midwives in prenatal care centres or at pregnant women houses. This trial is registered with IRCT2015072723370N1.",2020,"According to the results of Tukey's test, mean score changes of foot circumferences of both intervention groups were significantly different those of the control group.","['trained midwives in prenatal care centres or at pregnant women houses', ""participants' gestational age was 30-40 weeks"", 'Primigravidae', '90 primigravidae referred to public health centres of Zahedan, Iran', 'August 2016 to November 2017', 'pregnant women']","['foot massage using grape seed oil and sweet almond oil', 'Foot Massage with Grape Seed Oil and Sweet Almond Oil', 'grape seed and sweet almond oils', 'massage with grape seed oil, massage with sweet almond oil, and without intervention']","['mean score changes of foot circumferences', 'Physiological Leg Edema', 'pregnancy physiological edema', 'Foot circumferences', 'mean score change of foot circumferences']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0452182', 'cui_str': 'Referral to public health service'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0458160', 'cui_str': 'grape seed oil'}, {'cui': 'C0102271', 'cui_str': 'almond oil'}, {'cui': 'C0772453', 'cui_str': 'GRAPE SEED'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0235886', 'cui_str': 'Leg edema'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",,0.0537721,"According to the results of Tukey's test, mean score changes of foot circumferences of both intervention groups were significantly different those of the control group.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Navaee', 'Affiliation': 'Midwifery Department, Pregnancy Health Research Centre, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Rakhshkhorshid', 'Affiliation': 'Midwifery Department, Pregnancy Health Research Centre, Zahedan University of Medical Sciences, Zahedan, Iran.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/6835814']
2141,32419867,We Used a Double Blind Experiment to Investigate Weak pT-TMS in Epilepsy Patients.,"Magnetoencephalographic recordings, external picoTesla Transcranial Magnetic Stimulation (pT-TMS) and a double blind experimental design were used for the evaluation of 10 epilepsy patients (three males, seven females). Their ages ranged from 23 to 48 years. Our results showed an enhancement in the 2-7 Hz frequency range in five out of nine patients who had a statistically significant difference (55%). The pT-TMS could be a significant means for the treatment of epilepsy. Further research should be done prior to have final conclusions.",2020,Our results showed an enhancement in the 2-7 Hz frequency range in five out of nine patients who had a statistically significant difference (55%).,"['Epilepsy Patients', '10 epilepsy patients (three males, seven females']","['Magnetoencephalographic recordings, external picoTesla Transcranial Magnetic Stimulation (pT-TMS']",[],"[{'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",[],9.0,0.0524429,Our results showed an enhancement in the 2-7 Hz frequency range in five out of nine patients who had a statistically significant difference (55%).,"[{'ForeName': 'Anninos', 'Initials': 'A', 'LastName': 'Photios', 'Affiliation': 'Laboratory of Medical Physics, Department of Medicine, School of Health Sciences, Democritus University of Thrace, University Campus, Alexandroupoli, Greece.'}, {'ForeName': 'Anninou', 'Initials': 'A', 'LastName': 'Nicolia', 'Affiliation': 'Laboratory of Medical Physics, Department of Medicine, School of Health Sciences, Democritus University of Thrace, University Campus, Alexandroupoli, Greece.'}, {'ForeName': 'Adamopoulos', 'Initials': 'A', 'LastName': 'Adam', 'Affiliation': 'Laboratory of Medical Physics, Department of Medicine, School of Health Sciences, Democritus University of Thrace, University Campus, Alexandroupoli, Greece.'}, {'ForeName': 'Kotini', 'Initials': 'K', 'LastName': 'Athanasia', 'Affiliation': 'Laboratory of Medical Physics, Department of Medicine, School of Health Sciences, Democritus University of Thrace, University Campus, Alexandroupoli, Greece.'}, {'ForeName': 'Gemousakakis', 'Initials': 'G', 'LastName': 'Triandafillos', 'Affiliation': 'Laboratory of Medical Physics, Department of Medicine, School of Health Sciences, Democritus University of Thrace, University Campus, Alexandroupoli, Greece.'}, {'ForeName': 'Tsagas', 'Initials': 'T', 'LastName': 'Nicolaos', 'Affiliation': 'bDepartment of Electrical Engineering, Engineering Faculty, Democritus University of Thrace, Greece.'}]",Maedica,['10.26574/maedica.2020.15.1.92']
2142,32419935,Two regimens of dexamethasone versus prednisolone for acute exacerbations in asthmatic Egyptian children.,"Introduction


Asthma is one of the most prevalent chronic respiratory diseases, which often leads to an emergency department visit. Prednisolone is the most commonly used corticosteroid in treatment of asthma exacerbation. Oral dexamethasone demonstrates bioavailability similar to that of oral prednisolone but has a longer half-life.
Objective


To evaluate in adouble-blind, randomised clinical trial the efficacy of different doses of dexamethasone versus prednisolone in controlling asthma exacerbations in children.
Methods


We recruited 60 patients with asthma exacerbation, aged 2-11 years. Participants were randomly divided into three groups (20 patients each). Group I received a single dose of oral dexamethasone 0.3 mg/kg (maximum 12 mg), group II received 0.6 mg/kg/day of oral dexamethasone for 2 days (maximum 16 mg/day) and group III received 1.5 mg/kg/day oral prednisolone for 5 days (maximum 60 mg/day). Our primary outcomes were changes in Paediatric Respiratory Assessment Measure (PRAM), eosinophilic count and serum immunoglobulin E on day 5. Secondary endpoints were reporting any adverse effects and relapse rate during the 5 days. After 30 days, the Asthma Therapy Assessment Questionnaire (ATAQ) was given to the parents of the recruited patients.
Results


Among the three study groups, there was a highly statistically significant difference in IgE level, saturated oxygen, peak expiratory flow, forced expiratory volume in 1 s/forced vital capacity, PRAM and Modified Pulmonary Index Score; however, the eosinophilic count was significantly lower within the same group. Vomiting, gastrointestinal tract cramps, ATAQ and relapse rate showed a non-statistically significant difference.
Conclusion


Single-dose dexamethasone was at least as effective as 5-day course of prednisolone in controlling asthma, while dexamethasone for 2 days was non-inferior to 5 days of prednisolone in children with asthma exacerbation.",2020,"Among the three study groups, there was a highly statistically significant difference in IgE level, saturated oxygen, peak expiratory flow, forced expiratory volume in 1 s/forced vital capacity, PRAM and Modified Pulmonary Index Score; however, the eosinophilic count was significantly lower within the same group.","['60 patients with asthma exacerbation, aged 2-11 years', 'asthmatic Egyptian children', 'children with asthma exacerbation', 'children']","['dexamethasone', 'Oral dexamethasone', 'Prednisolone', 'oral dexamethasone', 'prednisolone']","['changes in Paediatric Respiratory Assessment Measure (PRAM), eosinophilic count and serum immunoglobulin E on day 5', 'eosinophilic count', 'Asthma Therapy Assessment Questionnaire (ATAQ', 'Vomiting, gastrointestinal tract cramps, ATAQ and relapse rate', 'IgE level, saturated oxygen, peak expiratory flow, forced expiratory volume in 1\u2009s/forced vital capacity, PRAM and Modified Pulmonary Index Score', 'adverse effects and relapse rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0013717', 'cui_str': 'Egyptian language'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0549075', 'cui_str': 'Respiratory assessment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0856520', 'cui_str': 'Serum immunoglobulin E'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",60.0,0.23355,"Among the three study groups, there was a highly statistically significant difference in IgE level, saturated oxygen, peak expiratory flow, forced expiratory volume in 1 s/forced vital capacity, PRAM and Modified Pulmonary Index Score; however, the eosinophilic count was significantly lower within the same group.","[{'ForeName': 'Dalia A', 'Initials': 'DA', 'LastName': 'Elkharwili', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Osama M', 'Initials': 'OM', 'LastName': 'Ibrahim', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Gamal A', 'Initials': 'GA', 'LastName': 'Elazab', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Shaymaa M', 'Initials': 'SM', 'LastName': 'Elrifaey', 'Affiliation': 'Pediatrics Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",European journal of hospital pharmacy : science and practice,['10.1136/ejhpharm-2018-001707']
2143,32419954,Value and learning from carer involvement in a cluster randomised controlled trial and process evaluation - Organising Support for Carers of Stroke Survivors (OSCARSS).,"Background


Patient, Carer and Public Involvement (PCPI) should be embedded in health care research. Delivering PCPI can be challenging, but even when PCPI is carried out it is rarely reported resulting in lost opportunities for learning. This paper aims to describe PCPI in the OSCARSS study, a pragmatic-cluster randomised controlled trial with an embedded economic and process evaluation.
Methods


A carer research user group (RUG) co-developed OSCARSS to evaluate how to best deliver support to caregivers of stroke survivors. The PCPI activity involved regular meetings and preparatory work, from the initial conceptualisation of the study through to dissemination. Written reports, structured group discussions and individual interviews were carried out with the RUG and researchers to capture the added value and learning. This paper was co-authored by two of the RUG members with contributions from the wider RUG and researchers.
Results


The core six members of the caregiver RUG attended the majority of the meetings alongside three researchers, one of whom was the co-chief investigator. PCPI was instrumental in changing many aspects of the research protocol, design and delivery and contributed to dissemination and sharing of good practice. There were challenges due to the emotional toll when PCPI members shared their stories and the extensive time commitment. Positive experiences of learning and fulfilment were reported by the individual researchers and PCPI members. Wider organisational administrative and financial support facilitated the PCPI. The researchers' existing positive regard for PCPI and the clear focus of the group were key to the successful co-design of this research.
Conclusions


The value and learning from the PCPI collaborative work with the researchers was of benefit to the study and the individuals involved. Specific PCPI influences were a challenge to pinpoint as successful co-design meant the researchers' and carers' contributions were intertwined and decision-making shared.",2020,Specific PCPI influences were a challenge to pinpoint as successful co-design meant the researchers' and carers' contributions were intertwined and decision-making shared.,['Carers of Stroke Survivors (OSCARSS'],[],[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",[],[],,0.0336259,Specific PCPI influences were a challenge to pinpoint as successful co-design meant the researchers' and carers' contributions were intertwined and decision-making shared.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mitchell', 'Affiliation': '1Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Burke', 'Affiliation': 'Patient and Carer Public Involvement (PCPI) contributors: lay members of the OSCARSS Carer Research User Group, Manchester, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Halford', 'Affiliation': 'Patient and Carer Public Involvement (PCPI) contributors: lay members of the OSCARSS Carer Research User Group, Manchester, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rothwell', 'Affiliation': '3Stroke Association support services, Stroke Association, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Darley', 'Affiliation': '1Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Woodward-Nutt', 'Affiliation': 'Research & Innovation, Northern Care Alliance NHS Group, Salford, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bowen', 'Affiliation': '1Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Patchwood', 'Affiliation': '1Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}]",Research involvement and engagement,['10.1186/s40900-020-00193-7']
2144,32420158,"Minimally invasive, sutureless, adolescent male circumcision with topical anesthetic: a field trial of Unicirc, a single-use surgical instrument.","Background


Circumcision has been shown to reduce the rate of HIV transmission in Africa. It is most cost effective if performed in younger men. Surgical assist devices can increase the efficiency and potentially reduce the cost of performing circumcisions.
Methods


We used the Unicirc disposable instrument to perform circumcisions in an outpatient primary care clinic. The trial was non-blinded. Circumcisions were performed under topical anaesthetic and the wound was sealed with cyanoacrylate tissue adhesive. The primary outcome was intraoperative duration; secondary outcomes were intraoperative and postoperative pain; adverse events (AEs); time to healing and patient satisfaction; and, cosmetic result.
Results


A total of 82 adolescent boys (aged 10-15 years) were circumcised. The median intraoperative time was 10 minutes and the median blood loss was 1 mL. All wounds were healed by 4 weeks and cosmetic results were excellent. There were no AEs.
Conclusions


Adolescent circumcision with Unicirc under topical anesthetic and wound sealing with cyanoacrylate tissue adhesive is safe, rapid, and heals by primary intention with excellent cosmetic results. It is cost effective and can be used for large scale programs.",2020,The median intraoperative time was 10 minutes and the median blood loss was 1 mL. All wounds were healed by 4 weeks and cosmetic results were excellent.,"['younger men', '82 adolescent boys (aged 10-15 years']",['topical anesthetic'],"['intraoperative duration; secondary outcomes were intraoperative and postoperative pain; adverse events (AEs); time to healing and patient satisfaction; and, cosmetic result', 'median blood loss', 'median intraoperative time']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",82.0,0.0857975,The median intraoperative time was 10 minutes and the median blood loss was 1 mL. All wounds were healed by 4 weeks and cosmetic results were excellent.,"[{'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Millard', 'Affiliation': 'Department of Family Medicine, University of New England, Biddeford, Maine, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Goldstuck', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of Stellenbosch, Cape Town, South Africa.'}]",Translational andrology and urology,['10.21037/tau.2019.12.16']
2145,32420246,Comparison between the 4K ultra-high definition (UHD) and high definition (HD) endoscopic systems for transoral endoscopic thyroidectomy.,"Background


The transoral endoscopic thyroidectomy vestibular approach (TOETVA) is the most recently introduced method of minimally invasive thyroid surgery. To our knowledge, no studies have compared TOETVA outcomes using different laparoscopic systems. This study compared outcomes of TOETVA using conventional high definition (HD) and ultra-high definition (UHD) equipment.
Methods


Medical data and surgery videos of 62 patients who randomized to undergo thyroid lobectomy by TOETVA using an HD or UHD system from August 2018 to April 2019 were retrospectively reviewed. Endoscopic procedures were divided into four phases: flap creation to isthmectomy (phase I); strap muscle division to upper pole ligation (phase II); trimming recurrent laryngeal nerve (phase III); and ligation of Berry's ligament to complete resection (phase IV).
Results


Of the 62 patients, 28 underwent TOETVA using an HD device and 34 using a UHD device. The clinical characteristics of the two groups were not different. Mean operating time for lobectomy was similar in the HD and UHD groups (44.19±9.94 versus 43.47±12.19 min, P=0.825). The times required for phases I (15.02±5.33 versus 13.67±5.44 min, P=0.397); II (12.89±2.84 versus 13.17±5.22 min, P=0.816); III (9.85±4.36 versus 9.98±4.55 min, P=0.918); and IV (6.43±3.69 versus 6.65±3.45 min, P=0.840) were also similar in the HD and UHD groups. The numbers of retrieved lymph nodes did not differ significantly in the HD and UHD groups (3.26±2.62 versus 3.45±2.81, P=0.807).
Conclusions


Applying a UHD system in TOETVA resulted in outcomes similar to those observed with a conventional HD system. Operation time tended to be lower, especially for flap dissection, and numbers of harvest lymph nodes tended to be higher in the UHD group. Large-scale studies are needed to assess the advantages of the UHD system.",2020,"Operation time tended to be lower, especially for flap dissection, and numbers of harvest lymph nodes tended to be higher in the UHD group.",['62 patients who randomized to undergo thyroid lobectomy by TOETVA using an HD or UHD system from August 2018 to April 2019 were retrospectively reviewed'],"[""flap creation to isthmectomy (phase I); strap muscle division to upper pole ligation (phase II); trimming recurrent laryngeal nerve (phase III); and ligation of Berry's ligament to complete resection (phase IV"", 'TOETVA using conventional high definition (HD) and ultra-high definition (UHD) equipment', 'transoral endoscopic thyroidectomy vestibular approach (TOETVA', 'transoral endoscopic thyroidectomy']","['Operation time', 'Mean operating time for lobectomy', 'numbers of retrieved lymph nodes', 'flap dissection, and numbers of harvest lymph nodes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0193804', 'cui_str': 'Thyroid isthmectomy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0183631', 'cui_str': 'Strap'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0441645', 'cui_str': 'Trimming - action'}, {'cui': 'C0034898', 'cui_str': 'Structure of recurrent laryngeal nerve'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0005135', 'cui_str': 'Berry'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]",,0.0198147,"Operation time tended to be lower, especially for flap dissection, and numbers of harvest lymph nodes tended to be higher in the UHD group.","[{'ForeName': 'Jong-Hyuk', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Surgery, Inha University Hospital, Incheon, Korea.'}, {'ForeName': 'Jae Hwan', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Inha University Hospital, Incheon, Korea.'}, {'ForeName': 'Jin Wook', 'Initials': 'JW', 'LastName': 'Yi', 'Affiliation': 'Department of Surgery, Inha University Hospital, Incheon, Korea.'}, {'ForeName': 'Min Hee', 'Initials': 'MH', 'LastName': 'Hur', 'Affiliation': 'Department of Surgery, Inha University Hospital, Incheon, Korea.'}]",Gland surgery,['10.21037/gs.2020.01.06']
2146,32416715,Osteoarthritis physical activity care pathway (OA-PCP): results of a feasibility trial.,"BACKGROUND


To obtain information on feasibility and acceptability, as well as preliminary data on efficacy, of an Osteoarthritis Physical activity Care Pathway (OA-PCP).
METHODS


This was a single group pilot study involving 60 participants with symptomatic, physician diagnosed knee or hip OA, recruited from primary care clinics. Participants self-reported completing less than 150 min per week of moderate-to-vigorous physical activity (MVPA) at baseline. The 3-month OA-PCP intervention involved 3 physical activity (PA) coaching calls (focused on goal setting), three check-in emails and linkage with community-based or online resources to support PA. Efficacy outcomes were collected at baseline and 4-month follow-up. The primary efficacy outcome was minutes of MVPA, assessed via accelerometer. Secondary outcomes included minutes of light intensity activity, sedentary minutes, step counts, and Western Ontario and McMaster Universities (WOMAC) pain and function subscales. Participants were also asked to rate the helpfulness of the OA-PCP intervention on a scale of 0-10. Differences in efficacy outcomes between baseline and 4-month follow-up were assessed using paired t-tests.
RESULTS


Among participants beginning the study, 88% completed follow-up assessments and ≥ 90% completed each of the intervention calls. Average daily minutes of MVPA was 8.0 at baseline (standard deviation (SD) = 9.9) and 8.9 at follow-up (SD = 12.1, p = 0.515). There were no statistically significant changes in light intensity activity, sedentary time or step counts. The mean WOMAC pain score improved from 8.1 (SD = 3.6) at baseline to 6.2 (SD = 3.8) at follow-up (p < 0.001); the mean WOMAC function score improved from 26.2 (SD = 13.2) to 20.2 (SD = 12.5; p < 0.001). The mean rating of helpfulness was 7.6 (SD = 2.5).
CONCLUSIONS


Results supported the feasibility and acceptability of the study, and participants reported clinically relevant improvements in pain and function. PA metrics did not improve substantially. Based on these results and participant feedback, modifications including enhanced self-monitoring are being made to increase the impact of the OA-PCP intervention on PA behavior.
TRIAL REGISTRATION


NCT03780400, December 19, 2018.",2020,"There were no statistically significant changes in light intensity activity, sedentary time or step counts.","['60 participants with symptomatic, physician diagnosed knee or hip OA, recruited from primary care clinics']","['Osteoarthritis physical activity care pathway (OA-PCP', 'OA-PCP intervention', 'OA-PCP intervention involved 3 physical activity (PA) coaching calls (focused on goal setting), three check-in emails and linkage with community-based or online resources to support PA']","['mean WOMAC function score', 'minutes of MVPA, assessed via accelerometer', 'feasibility and acceptability', 'light intensity activity, sedentary time or step counts', 'Average daily minutes of MVPA', 'mean WOMAC pain score', 'pain and function', 'Efficacy outcomes', 'minutes of light intensity activity, sedentary minutes, step counts, and Western Ontario and McMaster Universities (WOMAC) pain and function subscales', 'mean rating of helpfulness', 'efficacy outcomes', 'PA metrics']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]","[{'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",60.0,0.048199,"There were no statistically significant changes in light intensity activity, sedentary time or step counts.","[{'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Allen', 'Affiliation': 'Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA. kdallen@email.unc.edu.'}, {'ForeName': 'Maihan B', 'Initials': 'MB', 'LastName': 'Vu', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina, 1700 M.L.K. Jr Blvd #7426, Chapel Hill, NC, USA.'}, {'ForeName': 'Leigh F', 'Initials': 'LF', 'LastName': 'Callahan', 'Affiliation': 'Departments of Medicine, Orthopaedics and Social Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Cleveland', 'Affiliation': 'Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Abigail L', 'Initials': 'AL', 'LastName': 'Gilbert', 'Affiliation': 'Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Yvonne M', 'Initials': 'YM', 'LastName': 'Golightly', 'Affiliation': 'Department of Epidemiology, Injury Prevention Research Center, Division of Physical Therapy and Thurston Arthritis Research Center, |University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Griesemer', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, 170 Rosenau Hall, CB #7600, Chapel Hill, NC, USA.'}, {'ForeName': 'Kimberlea', 'Initials': 'K', 'LastName': 'Grimm', 'Affiliation': 'Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Derek P', 'Initials': 'DP', 'LastName': 'Hales', 'Affiliation': 'Department of Nutrition Gillings School of Global Public Health and Center for Health Promotion and Disease Prevention, University of North Carolina, 1700 M.L.K. Jr Blvd #7426, Chapel Hill, NC, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Hu', 'Affiliation': 'Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Huffman', 'Affiliation': 'Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Nelson', 'Affiliation': 'Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, USA.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Medical Facilities of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rees', 'Affiliation': 'North Carolina Translational and Clinical Sciences Institute, School of Medicine, University of North Carolina, Brinkhous-Bullitt Building, 160 Medical Dr, Chapel Hill, NC, USA.'}, {'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Rethorn', 'Affiliation': 'Department of Orthopedic Surgery, Duke University, 311 Trent Drive, Durham, NC, USA.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Wandishin', 'Affiliation': 'Department of Exercise and Sport Science and Thurston Arthritis Research Center, University of North Carolina, 3330 Thurston Bldg, CB #7280, Chapel Hill, NC, #7280, USA.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03339-6']
2147,30809671,"Comment on: Intravenous cyclophosphamide vs rituximab for the treatment of early diffuse scleroderma lung disease: open label, randomized, controlled trial: reply.",,2019,,['early diffuse scleroderma lung disease'],['cyclophosphamide vs rituximab'],[],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1258104', 'cui_str': 'Diffuse Systemic Sclerosis'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]",[],,0.0586778,,"[{'ForeName': 'Geetabali', 'Initials': 'G', 'LastName': 'Sircar', 'Affiliation': 'Department of Rheumatology, Institute of Postgraduate Medical Education and Research, Kolkata.'}, {'ForeName': 'Rudra Prosad', 'Initials': 'RP', 'LastName': 'Goswami', 'Affiliation': 'Department of Rheumatology, Institute of Postgraduate Medical Education and Research, Kolkata.'}, {'ForeName': 'Dipankar', 'Initials': 'D', 'LastName': 'Sircar', 'Affiliation': 'Department of Nephrology, Institute of Postgraduate Medical Education and Research, Kolkata.'}, {'ForeName': 'Alakendu', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': 'Department of Rheumatology, Institute of Postgraduate Medical Education and Research, Kolkata.'}, {'ForeName': 'Parasar', 'Initials': 'P', 'LastName': 'Ghosh', 'Affiliation': 'Department of Rheumatology, Institute of Postgraduate Medical Education and Research, Kolkata.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez054']
2148,30809674,"Comment on: Intravenous cyclophosphamide vs rituximab for the treatment of early diffuse scleroderma lung disease: open label, randomized, controlled trial.",,2019,,['early diffuse scleroderma lung disease'],['cyclophosphamide vs rituximab'],[],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1258104', 'cui_str': 'Diffuse Systemic Sclerosis'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]",[],,0.0625888,,"[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Oral', 'Affiliation': 'Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Bilgin', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ertuğrul Çağrı', 'Initials': 'EÇ', 'LastName': 'Bölek', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Gözde Kübra', 'Initials': 'GK', 'LastName': 'Yardımcı', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Kılıç', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez033']
2149,32416538,"Peer outreach point-of-care testing as a bridge to hepatitis C care for people who inject drugs in Toronto, Canada.","BACKGROUND


People who inject drugs have high rates of hepatitis C (HCV) and yet many remain undiagnosed and untreated. HCV treatment guidelines and elimination strategies recommend task-shifting to expand where, and by whom, HCV testing and care is delivered.
METHODS


A randomized controlled trial design was used to evaluate if point-of-care (POC) HCV antibody testing by peer outreach workers outside of health and social service spaces would improve engagement in HCV care. People with a lifetime history of injection drug use without prior knowledge of HCV antibody status were randomized to receive HCV outreach plus either POC or referral to community-based HCV program for testing as usual. The study was co-designed by people with lived experience of HCV.
RESULTS


920 people were approached to participate over 14 weeks. After refusals, withdrawals and removal of duplicates, there were 380 study participants. Outreach took place primarily in public spaces (66%) such as parks, coffee shops and apartment lobbies. Participants reported very high rates of poverty, housing instability and recent injection drug use. Despite being at high risk for HCV, 61% had no history or knowledge of past HCV testing (n = 230). Of those who received a POC test 77/195 (39%) were positive for HCV antibodies. There was no change in rates of engagement in HCV care among those who received the POC (n = 6; 3%) compared to those who did not (n = 5; 3%).
CONCLUSION


Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing. This improved participants' knowledge of their HCV antibody status, but that knowledge in itself did not lead to any change in participant's subsequent engagement in HCV care. Future work is required to evaluate strategies such as incentives or peer navigators to improve linkage to HCV care after diagnosis.",2020,Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing.,"['people with lived experience of HCV', '920 people were approached to participate over 14 weeks', 'by peer outreach workers outside of health and social service spaces', 'People with a lifetime history of injection drug use without prior knowledge of HCV antibody status', 'people who inject drugs in Toronto, Canada']","['HCV outreach plus either POC or referral to community-based HCV program', 'care (POC) HCV antibody testing']",['rates of engagement in HCV care'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}]",920.0,0.0380034,Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Broad', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Mason', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Guyton', 'Affiliation': 'Sherbourne Health, 333 Sherbourne St, Toronto, ON M5A 2S5, Canada.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Lettner', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada; Regent Park Community Health Centre, 465 Dundas St East, Toronto, ON M5A 2B2, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Matelski', 'Affiliation': 'University Health Network, 235 - 200 Elizabeth St, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Powis', 'Affiliation': 'Michael Garron Hospital, 825 Coxwell Ave, Toronto, ON M4C 3E7, Canada. Electronic address: jeff.powis@tehn.ca.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102755']
2150,32419791,"Laser Acupuncture Alleviates Symptoms and Improves Quality of Life in Women with Overactive Bladder: A Double-Blind, Pilot Randomized Controlled Trial.","Objective


The aim of this study was to investigate the clinical efficacy of laser acupuncture for the treatment of women with overactive bladder (OAB) in Taiwan.
Methods


A double-blind randomized controlled trial was conducted on female patients with OAB symptoms referred from gynecologists, and subjects were divided into two groups using blocked randomization. LaserPan (RJ-Laser, Germany) was applied to seven selected acupuncture points. The subjects received laser acupuncture 3 times per week for 3 weeks, 9 sessions in total. Basic patient data, Overactive Bladder Symptom Score (OABSS), Incontinence Impact Questionnaire (IIQ-7), and Urogenital Distress Inventory (UDI-6) scores were recorded prior to first treatment and at the end of 3 rd , 6 th , and 9 th  treatments.
Results


Thirty patients were enrolled, and twenty-seven patients completed all treatments in this study. The OABSS total score of the experimental group decreased significantly by 3.13 ( p  ≤ 0.001), 4.60 ( p  ≤ 0.001), and 3.79 ( p  ≤ 0.001) after 3 rd , 6 th , and 9 th  treatments, respectively, compared with that of the control group. The IIQ-7 score declined significantly from baseline by 4.57 ( p =0.003) and 3.63 ( p =0.023) after 3 rd  and 6 th  treatments, respectively, compared with that of the control group. Similarly, the UDI-6 score of the experimental group exhibited a significant decrease from baseline by 1.90 ( p =0.042) and 2.25 ( p =0.025) after 6 th  and 9 th  interventions, respectively, compared with that of the control group.
Conclusions


This study demonstrates that laser acupuncture can alleviate OAB symptoms and improve quality of life. This noninvasive device could be an effective therapy for women with OAB.",2020,"The OABSS total score of the experimental group decreased significantly by 3.13 ( p  ≤ 0.001), 4.60 ( p  ≤ 0.001), and 3.79 ( p  ≤ 0.001) after 3 rd , 6 th , and 9 th  treatments, respectively, compared with that of the control group.","['Women with Overactive Bladder', 'Thirty patients were enrolled, and twenty-seven patients completed all treatments in this study', 'women with overactive bladder (OAB) in Taiwan', 'female patients with OAB symptoms referred from gynecologists, and subjects', 'women with OAB']","['LaserPan (RJ-Laser, Germany', 'laser acupuncture', 'Laser Acupuncture']","['clinical efficacy', 'Quality of Life', 'OAB symptoms and improve quality of life', 'Basic patient data, Overactive Bladder Symptom Score (OABSS), Incontinence Impact Questionnaire (IIQ-7), and Urogenital Distress Inventory (UDI-6) scores', 'IIQ-7 score', 'OABSS total score', 'UDI-6 score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0394654', 'cui_str': 'Laser acupuncture'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",30.0,0.19009,"The OABSS total score of the experimental group decreased significantly by 3.13 ( p  ≤ 0.001), 4.60 ( p  ≤ 0.001), and 3.79 ( p  ≤ 0.001) after 3 rd , 6 th , and 9 th  treatments, respectively, compared with that of the control group.","[{'ForeName': 'Yu-Wei', 'Initials': 'YW', 'LastName': 'Chang', 'Affiliation': 'Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Keelung Medical Center, Keelung, Taiwan.'}, {'ForeName': 'Tsia-Shu', 'Initials': 'TS', 'LastName': 'Lo', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Medical Center, Linkou, Taoyuan, Taiwan.'}, {'ForeName': 'Hsin-Ning', 'Initials': 'HN', 'LastName': 'Chang', 'Affiliation': 'Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Keelung Medical Center, Keelung, Taiwan.'}, {'ForeName': 'Yi-Hsien', 'Initials': 'YH', 'LastName': 'Shiao', 'Affiliation': 'Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Keelung Medical Center, Keelung, Taiwan.'}, {'ForeName': 'Yuan-Chieh', 'Initials': 'YC', 'LastName': 'Yeh', 'Affiliation': 'Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Keelung Medical Center, Keelung, Taiwan.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/1705964']
2151,31553463,Assessment of Laparoscopic Distal Gastrectomy After Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: A Randomized Clinical Trial.,"Importance


Laparoscopic distal gastrectomy and neoadjuvant chemotherapy are increasingly used to treat locally advanced gastric cancer. However, the safety and efficacy of the laparoscopic procedure after neoadjuvant chemotherapy remain unclear.
Objective


To evaluate the short-term outcomes of patients with locally advanced gastric cancer who received either laparoscopic distal gastrectomy or open distal gastrectomy.
Design, Setting, and Participants


Between April 23, 2015, and November 16, 2017, a phase 2, open-label, noninferiority randomized clinical trial was conducted at the Gastrointestinal Cancer Center of Peking University Cancer Hospital and Institute in Beijing, China. Patients (n = 96) between 18 and 80 years of age with locally advanced gastric cancer (cT2-4aN+M0) who were receiving neoadjuvant chemotherapy were enrolled and randomized. An as-treated population and a modified intention-to-treat (mITT) population were defined for the data analysis.
Interventions


Patients were randomized to undergo either laparoscopy-assisted distal gastrectomy (LADG) with D2 lymphadenectomy or open distal gastrectomy (ODG) with D2 lymphadenectomy.
Main Outcomes and Measures


The primary end point was 3-year recurrence-free survival rate. Secondary end points were surgical radicality, 30-day postoperative morbidity and mortality, 2-week postoperative recovery indexes, and adjuvant chemotherapy completion status.
Results


In total, 95 patients were eligible for as-treated analyses (LADG: 45, of whom 13 were female [29%], with a median [interquartile range (IQR)] age of 59 [52-65] years; ODG: 50, of whom 16 were female [32%], with a median [IQR] age of 61 [55-64] years) and mITT analyses (LADG: 47, of whom 14 were female [30%], with a median [IQR] age of 59 [52-65] years; ODG: 48, of whom 15 were female [31%], with a median [IQR] age of 61 [55-64] years). In the as-treated analyses, the LADG group had a significantly lower postoperative complication rate than the ODG group (20% vs 46%; P = .007). The postoperative visual analog scale score for pain was 1.2 units lower on postoperative day 2 only in the LADG group (95% CI, -2.1 to -0.3; P = .008). Patients in the LADG group had better adjuvant chemotherapy completion (adjusted odds ratio, 4.39; 95% CI, 1.63-11.80; P = .003) and were less likely to terminate adjuvant chemotherapy because of adverse effects (10 [22%] vs 21 [42%]; P = .04). The mITT analyses showed similar results to as-treated analyses.
Conclusions and Relevance


This trial found that LADG appears to offer the benefits of better postoperative safety and adjuvant chemotherapy tolerance compared with ODG for patients with locally advanced gastric cancer who received neoadjuvant chemotherapy.
Trial Registration


ClinicalTrials.gov identifier: NCT02404753.",2019,"Patients in the LADG group had better adjuvant chemotherapy completion (adjusted odds ratio, 4.39; 95% CI, 1.63-11.80; P = .003) and were less likely to terminate adjuvant chemotherapy because of adverse effects (10 [22%] vs 21 [42%];","['patients with locally advanced gastric cancer who received either', 'age of 59 [52-65] years; ODG: 50, of whom 16 were female [32%], with a median [IQR] age of 61 [55-64] years) and mITT analyses', '47, of whom 14 were female [30%], with a median [IQR] age of 59 [52-65] years; ODG: 48, of whom 15 were female [31%], with a median [IQR] age of 61 [55-64] years', 'Participants\n\n\nBetween April 23, 2015, and November 16, 2017, a phase 2, open-label, noninferiority randomized clinical trial was conducted at the Gastrointestinal Cancer Center of Peking University Cancer Hospital and Institute in Beijing, China', 'locally advanced gastric cancer', 'Patients (n\u2009=\u200996) between 18 and 80 years of age with locally advanced gastric cancer (cT2-4aN+M0) who were receiving', '95 patients were eligible for as-treated analyses (LADG: 45, of whom 13 were female [29%], with a median [interquartile range (IQR', 'Locally Advanced Gastric Cancer', 'patients with locally advanced gastric cancer who received neoadjuvant chemotherapy']","['ODG', 'laparoscopy-assisted distal gastrectomy (LADG) with D2 lymphadenectomy or open distal gastrectomy (ODG) with D2 lymphadenectomy', 'LADG', 'Laparoscopic Distal Gastrectomy', 'neoadjuvant chemotherapy', 'laparoscopic distal gastrectomy or open distal gastrectomy', 'Laparoscopic distal gastrectomy and neoadjuvant chemotherapy', 'Neoadjuvant Chemotherapy']","['adverse effects', 'postoperative complication rate', 'adjuvant chemotherapy completion', '3-year recurrence-free survival rate', 'surgical radicality, 30-day postoperative morbidity and mortality, 2-week postoperative recovery indexes, and adjuvant chemotherapy completion status', 'postoperative visual analog scale score for pain', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0206034', 'cui_str': 'Clinical Trials, Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0019999', 'cui_str': 'Hospitals, Cancer'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",95.0,0.25282,"Patients in the LADG group had better adjuvant chemotherapy completion (adjusted odds ratio, 4.39; 95% CI, 1.63-11.80; P = .003) and were less likely to terminate adjuvant chemotherapy because of adverse effects (10 [22%] vs 21 [42%];","[{'ForeName': 'Ziyu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shan', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Xiangji', 'Initials': 'X', 'LastName': 'Ying', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Jian-Yu', 'Initials': 'JY', 'LastName': 'E', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Yinkui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Jiafu', 'Initials': 'J', 'LastName': 'Ji', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}]",JAMA surgery,['10.1001/jamasurg.2019.3473']
2152,32419828,"Effect of Peat Intervention on Pain and Gait in Patients with Knee Osteoarthritis: A Prospective, Double-Blind, Randomized, Controlled Study.","Methods


Knee osteoarthritis patients with Visual Analog Scale (VAS) of 3 or more and Kellgren-Lawrence osteoarthritis grades 1 to 3 were included. Patients with history of intraarticular injection treatment were excluded. Forty-one participants were randomly allocated to the peat intervention group ( n  = 22) or the hot-pack-only control group ( n  = 19). Peat and hot pack were applied to both knees of each group of patients. Each intervention session lasted 20 minutes, and eight sessions were completed over five days. VAS, serum cartilage oligomeric matrix protein (COMP), and gait parameters were evaluated before and after the whole interventions.
Results


VAS in the peat group decreased from 6.000 to 3.409 after intervention ( p  < 0.001) and also decreased in the control group from 5.737 to 4.421 ( p  < 0.001). VAS score reduction between two periods was greater in the peat group than that in the control group ( p  < 0.001). There was no significant difference in the serum COMP level in either intergroup or intragroup analysis. In gait analysis, the gait velocity of the peat group increased from 0.781 m/s to 0.873 m/s after intervention ( p =0.002), while it decreased in the control group. The knee varus/valgus range of motion during gaits was reduced from 11.455° to 8.439° after intervention in the peat group ( p =0.006).
Conclusions


This study showed that peat can be considered as a therapeutic option for pain relief of knee osteoarthritis patients. The reduction in knee joint varus/valgus range of motion and the increase in gait velocity after peat intervention were also identified through this research, which is the first to analyze the effects of peat on gait.",2020,"The reduction in knee joint varus/valgus range of motion and the increase in gait velocity after peat intervention were also identified through this research, which is the first to analyze the effects of peat on gait.","['Patients with history of intraarticular injection treatment were excluded', 'Patients with Knee Osteoarthritis', 'Forty-one participants', 'Methods\n\n\nKnee osteoarthritis patients with Visual Analog Scale (VAS) of 3 or more and Kellgren-Lawrence osteoarthritis grades 1 to 3 were included', 'knee osteoarthritis patients']","['peat intervention group ( n \u2009=\u200922) or the hot-pack-only control group', 'Peat Intervention']","['VAS score reduction', 'gait velocity', 'VAS, serum cartilage oligomeric matrix protein (COMP), and gait parameters', 'Pain and Gait', 'serum COMP level', 'knee varus/valgus range of motion during gaits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0030739', 'cui_str': 'Peat'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0601900', 'cui_str': 'COMP (Cartilage Oligomeric Matrix Protein)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0056167', 'cui_str': 'COMP protocol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",41.0,0.0170181,"The reduction in knee joint varus/valgus range of motion and the increase in gait velocity after peat intervention were also identified through this research, which is the first to analyze the effects of peat on gait.","[{'ForeName': 'Myeongkyu', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Hanyang University College of Medicine, 222, Wangsimni-ro, Seongdong-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Kyu Hoon', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Hanyang University College of Medicine, 222, Wangsimni-ro, Seongdong-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Hoon', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Rehabilitation Medicine, Hanyang University Guri Hospital, 153, Gyeongchun-ro, Guri-si, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Sung Jae', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Integrative Medicine, Korea University School of Medicine, 73, Goryeodae-ro, Seongbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Choong-Gon', 'Initials': 'CG', 'LastName': 'Kim', 'Affiliation': 'Marine Ecosystem Research Center, Korea Institute of Ocean Science & Technology, 385, Haeyang-ro, Yeongdo-gu, Busan, Republic of Korea.'}, {'ForeName': 'Jae Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Marine Ecosystem Research Center, Korea Institute of Ocean Science & Technology, 385, Haeyang-ro, Yeongdo-gu, Busan, Republic of Korea.'}, {'ForeName': 'Sun Hee', 'Initials': 'SH', 'LastName': 'Hwang', 'Affiliation': 'Medical Business Department, Corporate Research Institute, Rbiotech Co., Ltd., 2-409, 775, Gyeongin-ro, Yeongdeungpo-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Si-Bog', 'Initials': 'SB', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Hanyang University College of Medicine, 222, Wangsimni-ro, Seongdong-gu, Seoul, Republic of Korea.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/8093526']
2153,32420318,"Pressure-Controlled Ventilation-Volume Guaranteed Mode Combined with an Open-Lung Approach Improves Lung Mechanics, Oxygenation Parameters, and the Inflammatory Response during One-Lung Ventilation: A Randomized Controlled Trial.","We evaluated the effectiveness of pressure-controlled ventilation-volume guaranteed (PCV-VG) mode combined with open-lung approach (OLA) in patients during one-lung ventilation (OLV). First, 176 patients undergoing thoracoscopic surgery were allocated randomly to four groups: PCV+OLA (45 cases, PCV-VG mode plus OLA involving application of individualized positive end-expiratory pressure (PEEP) after a recruitment maneuver), PCV (44 cases, PCV-VG mode plus standard lung-protective ventilation with fixed PEEP of 5 cmH 2 O), VCV+OLA (45 cases, volume-controlled ventilation (VCV) plus OLA), and VCV (42 cases, VCV plus standard lung-protective ventilation). Mean airway pressure ( P   mean ), dynamic compliance (Cdyn), PaO 2 /FiO 2  ratio, intrapulmonary shunt ratio (Qs/Qt), dead space fraction ( V   D / V   T ), and plasma concentration of neutrophil elastase were obtained to assess the effects of four lung-protective ventilation strategies. At 45 min after OLV, the median (interquartile range (IQR))  P   mean  was higher in the PCV+OLA group (13.00 (12.00, 13.00) cmH 2 O) and the VCV+OLA group (12.00 (12.00, 14.00) cmH 2 O) than in the PCV group (11.00 (10.00, 12.00) cmH 2 O) and the VCV group (11.00 (10.00, 12.00) cmH 2 O) ( P  < 0.05); the median (IQR) Cdyn was higher in the PCV+OLA group (27.00 (24.00, 32.00) mL/cmH 2 O) and the VCV+OLA group (27.00 (22.00, 30.00) mL/cmH 2 O) than in the PCV group (23.00 (21.00, 25.00) mL/cmH 2 O) and the VCV group (20.00 (18.75, 21.00) mL/cmH 2 O) ( P  < 0.05); the median (IQR) Qs/Qt in the PCV+OLA group (0.17 (0.16, 0.19)) was significantly lower than that in the PCV group (0.19 (0.18, 0.20)) and the VCV group (0.19 (0.17, 0.20)) ( P  < 0.05);  V   D / V   T  was lower in the PCV+OLA group (0.18 ± 0.05) and the VCV+OLA group (0.19 ± 0.07) than in the PCV group (0.21 ± 0.07) and the VCV group (0.22 ± 0.06) ( P  < 0.05). The concentration of neutrophil elastase was lower in the PCV+OLA group than in the PCV, VCV+OLA, and VCV groups at total-lung ventilation 10 min after OLV (162.47 ± 25.71, 198.58 ± 41.99, 200.84 ± 22.17, and 286.95 ± 21.10 ng/mL, resp.) ( P  < 0.05). In conclusion, PCV-VG mode combined with an OLA strategy leads to favorable effects upon lung mechanics, oxygenation parameters, and the inflammatory response during OLV.",2020,"The concentration of neutrophil elastase was lower in the PCV+OLA group than in the PCV, VCV+OLA, and VCV groups at total-lung ventilation 10 min after OLV (162.47 ± 25.71, 198.58 ± 41.99, 200.84 ± 22.17, and 286.95 ± 21.10 ng/mL, resp.)","['176 patients undergoing thoracoscopic surgery', 'One-Lung Ventilation', 'patients during one-lung ventilation (OLV']","['VCV+OLA', 'PCV+OLA (45 cases, PCV-VG mode plus OLA involving application of individualized positive end-expiratory pressure (PEEP) after a recruitment maneuver), PCV (44 cases, PCV-VG mode plus standard lung-protective ventilation with fixed PEEP of 5\u2009cmH 2 O), VCV+OLA (45 cases, volume-controlled ventilation (VCV) plus OLA), and VCV (42 cases, VCV plus standard lung-protective ventilation', 'PCV', 'Pressure-Controlled Ventilation-Volume Guaranteed Mode', 'pressure-controlled ventilation-volume guaranteed (PCV-VG) mode combined with open-lung approach (OLA']","['Mean airway pressure ( P   mean ), dynamic compliance (Cdyn), PaO 2 /FiO 2  ratio, intrapulmonary shunt ratio (Qs/Qt), dead space fraction ( V   D / V   T ), and plasma concentration of neutrophil elastase', 'median (interquartile range (IQR))  P   mean', 'median (IQR) Cdyn', 'median (IQR) Qs/Qt', 'concentration of neutrophil elastase', 'Lung Mechanics, Oxygenation Parameters, and the Inflammatory Response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0489642', 'cui_str': 'Intrapulmonary shunt'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0231965', 'cui_str': 'Dead space gas volume'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0064833', 'cui_str': 'Leukocyte elastase'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",176.0,0.0218311,"The concentration of neutrophil elastase was lower in the PCV+OLA group than in the PCV, VCV+OLA, and VCV groups at total-lung ventilation 10 min after OLV (162.47 ± 25.71, 198.58 ± 41.99, 200.84 ± 22.17, and 286.95 ± 21.10 ng/mL, resp.)","[{'ForeName': 'Jianli', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Hebei General Hospital, Shijiazhuang 050051, China.'}, {'ForeName': 'Baogui', 'Initials': 'B', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology, Hebei General Hospital, Shijiazhuang 050051, China.'}, {'ForeName': 'Dongdong', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Hebei General Hospital, Shijiazhuang 050051, China.'}, {'ForeName': 'Meinv', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Hebei General Hospital, Shijiazhuang 050051, China.'}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Hebei General Hospital, Shijiazhuang 050051, China.'}, {'ForeName': 'Junfang', 'Initials': 'J', 'LastName': 'Rong', 'Affiliation': 'Department of Anesthesiology, Hebei General Hospital, Shijiazhuang 050051, China.'}]",BioMed research international,['10.1155/2020/1403053']
2154,32419786,Effect of donepezil and memantine on improvement of cognitive function in patients with temporal lobe epilepsy.,"Background


Cognitive impairment is a common complication of patients with temporal lobe epilepsy (TLE). Therefore, the aim of this study was to compare the effects of donepezil and memantine on improving the cognitive function of patients with TLE.
Materials and Methods


In a clinical trial study, 70 patients with TLE were divided into two groups of 35 each: 10 mg doses of donepezil (first group) and memantine (second group) were applied for 16 weeks. The level of cognitive function of patients in both groups before and after treatment was determined using Montreal Cognitive Assessment (MoCA) test.
Results


The mean score of MoCA before and after intervention was 23.55 ± 3.67 and 26.09 ± 2.5, respectively, in the group treated with memantine, and the mean score of intervention was significantly improved ( P  < 0.001). In the group treated with donepezil, the score before and after the operation was 23.87 ± 3.18 and 24.35 ± 2.17, respectively, and no significant difference was observed in this group ( P  = 0.38).
Conclusion


Hence, memantine was better than donepezil in the improvement of cognitive impairment in patients with TLE.",2020,"The level of cognitive function of patients in both groups before and after treatment was determined using Montreal Cognitive Assessment (MoCA) test.
","['70 patients with TLE', 'patients with temporal lobe epilepsy', 'patients with TLE', 'patients with temporal lobe epilepsy (TLE']","['donepezil and memantine', 'memantine', 'donepezil']","['Montreal Cognitive Assessment (MoCA) test', 'cognitive function', 'mean score of intervention', 'cognitive impairment', 'mean score of MoCA', 'level of cognitive function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014556', 'cui_str': 'Temporal lobe epilepsy'}]","[{'cui': 'C3652776', 'cui_str': 'donepezil and memantine'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}]","[{'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",70.0,0.0301068,"The level of cognitive function of patients in both groups before and after treatment was determined using Montreal Cognitive Assessment (MoCA) test.
","[{'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Oustad', 'Affiliation': 'Department of Neurology, Medical School, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Najafi', 'Affiliation': 'Department of Neurology, Medical School, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Mehvari', 'Affiliation': 'Department of Neurology, Medical School, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Rastgoo', 'Affiliation': 'Neurosurgeon, Imam Khomeini Hospital, Kangan, Bushehr University of Medical Sciences, Bushehr, Iran.'}, {'ForeName': 'Zahrasadat', 'Initials': 'Z', 'LastName': 'Mortazavi', 'Affiliation': 'Department of Neurology, Medical School, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Rahiminejad', 'Affiliation': 'Department of Neurology, Medical School, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences,['10.4103/jrms.JRMS_209_19']
2155,32419861,Combination Therapy and Opioids: Effectiveness of Transcranial Direct-Current Stimulation (tDCS) and Emotion Regulation Training in Reducing Current Drug Craving.,"Background and objectives:  Craving is the main symptom of addiction that is accompanied by dependence and relapse. The present study was aimed to compare the effectiveness of combined Transcranial Direct-Current Stimulation (tDCS) and emotion regulation training with that of separate tDCS and emotion regulation training in reducing current drug craving and thoughts and fantasies about drug use.  Materials and methodology:  This was a quasi-experimental study with a pretest-posttest design and three intervention groups. The statistical population included all patients dependent on opioids in medium-term residential drug rehabilitation centers in Zahedan, Iran, in 2018-2019. From eight randomly selected centers, a total of 54 patients were selected based on inclusion and exclusion criteria, and randomly divided into three intervention groups. Data were gathered using the Personal Drug Use Questionnaire, Desires for Drug Questionnaire (DDQ), and Drug Use Thoughts, Fantasies, and Temptations Questionnaire. All analyses were performed using SPSS-16.  Results:  The Kruskal-Wallis test indicated significant differences between the three intervention groups in current drug craving and thoughts and fantasies about drug use (P ..001). In addition, examination of the mean rank showed that t significant decrease was higher for the combined tDCS and emotion regulation training group.  Conclusion:  Addiction is very similar to other chronic disorders. Therefore, combined (integrated) therapies can have a very important role in treating addiction, especially in relapse prevention.",2020,"In addition, examination of the mean rank showed that t significant decrease was higher for the combined tDCS and emotion regulation training group.  ","['patients dependent on opioids in medium-term residential drug rehabilitation centers in Zahedan, Iran, in 2018-2019', 'From eight randomly selected centers, a total of 54 patients were selected based on inclusion and exclusion criteria']","['combined Transcranial Direct-Current Stimulation (tDCS) and emotion regulation training with that of separate tDCS and emotion regulation training', 'Transcranial Direct-Current Stimulation (tDCS) and Emotion Regulation Training', 'Combination Therapy and Opioids']","['current drug craving and thoughts and fantasies about drug use', 'Personal Drug Use Questionnaire, Desires for Drug Questionnaire (DDQ), and Drug Use Thoughts, Fantasies, and Temptations Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1510463', 'cui_str': 'Drug Rehabilitation Centers'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0556446', 'cui_str': 'Craves for drugs'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0015630', 'cui_str': 'Fantasy'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",54.0,0.0197076,"In addition, examination of the mean rank showed that t significant decrease was higher for the combined tDCS and emotion regulation training group.  ","[{'ForeName': 'Kooteh', 'Initials': 'K', 'LastName': 'Behzad Rigi', 'Affiliation': 'Department of Clinical Psychology, Faculty of Behavioral Science, University of Social Welfare and Rehabilitation Science, Tehran, Iran.'}, {'ForeName': 'Dolatshahi', 'Initials': 'D', 'LastName': 'Behrooz', 'Affiliation': 'Substance Abuse and Dependence Research Center, Department of Clinical Psychology, University of Social Welfare and Rehabilitation Science, Tehran, Iran.'}, {'ForeName': 'Nosratabadi', 'Initials': 'N', 'LastName': 'Masoud', 'Affiliation': 'University of Social Welfare and Rehabilitation Science, Paarand Specialized Center for Human Enhancement, Tehran, Iran.'}, {'ForeName': 'Bakhshani', 'Initials': 'B', 'LastName': 'Nour Mohammad', 'Affiliation': ""Children and Adolescents' Health Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.""}, {'ForeName': 'Mahdavi', 'Initials': 'M', 'LastName': 'Abed', 'Affiliation': 'Department of Psychology and Educational Sciences, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Hakami', 'Initials': 'H', 'LastName': 'Mousa Chakeri', 'Affiliation': 'Department of Clinical Psychology, Faculty of Behavioral Science, University of Social Welfare and Rehabilitation Science, Tehran, Iran.'}]",Maedica,['10.26574/maedica.2020.15.1.53']
2156,32419880,Image quality and radiation exposure with low-contrast-dose computed tomography angiography of the lower extremities.,"Introduction


Multidetector computed tomography is the reference standard for the diagnosis of peripheral arterial disease (PAD). The aim of this study is to optimise the image quality of computed tomography (CT) scanning for the diagnosis of PAD with the lowest possible radiation and contrast volume.
Material and methods


Seventy-two patients were referred for evaluation of suspected PAD with CT angiography. Patients were randomly assigned to an optimise care dose of kVp - group A,  n  = 36; 18 men, 18 women; mean age, 63 years with standard deviation 15; range, 20-88 years (contrast volume 80-85 ml was injected automatically with bolus tracking, and group B,  n  = 36; 18 men, 18 women; mean age, 61 years with standard deviation 16; range, 26-88 years (contrast volume 120-140 ml was injected automatically with bolus tracking). Other scanning parameters were kept constant. Lower extremities vessel enhancement and image noise were quantified, and the signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) were calculated. Subjective vessel contrast was assessed by two radiologists in consensus.
Result


A total of 16 cases of PAD (22.2%) were found in the evaluated of subjects (10 in group A, and six in group B).All PAD cases were detected by the two readers. There was no significant difference in the size or location of the PAD between the two groups; the average image noise was 19 HU for group A and 16 HU for group B. The difference was not statistically significant ( p  = 0.183). Overall, the SNR and CNR were slightly higher in group B (25.5 and 24.1, respectively) compared with group A (20 and 17.4, respectively), but those differences were not statistically significant ( p  = 061 and  p  = 0.38, respectively).
Conclusions


All patients were evaluated by lower extremities CTA protocol allowing similar image quality to be achieved in both groups, with optimised care dose for both protocols, and contrast volume was reduced by 40% in the new protocol group compared to the conventional protocol group.",2020,"Overall, the SNR and CNR were slightly higher in group B (25.5 and 24.1, respectively) compared with group A (20 and 17.4, respectively), but those differences were not statistically significant ( p  = 061 and  p  = 0.38, respectively).
","['group A,  n  = 36; 18 men, 18 women; mean age, 63 years with standard deviation 15; range, 20-88 years (contrast volume 80-85 ml was injected automatically with bolus tracking, and group B,  n  = 36; 18 men, 18 women; mean age, 61 years with standard deviation 16; range, 26-88 years ', 'Material and methods\n\n\nSeventy-two patients were referred for evaluation of suspected PAD with CT angiography']","['contrast volume 120-140 ml was injected automatically with bolus tracking', 'Introduction\n\n\nMultidetector computed tomography', 'optimise care dose of kVp ', 'low-contrast-dose computed tomography angiography', 'computed tomography (CT) scanning']","['size or location of the PAD', 'Subjective vessel contrast', 'signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR', 'Lower extremities vessel enhancement and image noise', 'SNR and CNR', 'Image quality and radiation exposure']","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C3179130', 'cui_str': 'Multidetector-Row Computed Tomography'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}]",72.0,0.0446452,"Overall, the SNR and CNR were slightly higher in group B (25.5 and 24.1, respectively) compared with group A (20 and 17.4, respectively), but those differences were not statistically significant ( p  = 061 and  p  = 0.38, respectively).
","[{'ForeName': 'Abed Al Nasser', 'Initials': 'AAN', 'LastName': 'Assi', 'Affiliation': 'Department of Medical Imaging, Arab American University, Jenin, Palestine.'}]",Polish journal of radiology,['10.5114/pjr.2020.94297']
2157,32420251,Comparing Ligasure TM  Exact dissector with other energy devices in total thyroidectomy: a pilot study.,"Background


Hemostasis is fundamental in thyroid surgery. The aim of this randomized active comparator-controlled study was to compare the effectiveness of Ligasure TM  Exact to previously existing sealing devices in patients undergoing thyroidectomy.
Methods


A total of 180 patients were randomly allocated into 4 groups according to the hemostatic device used: Focus Harmonic Scalpel ®  (FHS), Ligasure TM  Small Jaw (LSJ), Thunderbeat ®  (TB), and Ligasure TM  Exact (LE). We recorded epidemiologic and biochemical data, operative difficulty, postoperative vocal alteration and pain, complications, operating time, grams of gland excised per minute, and hospitalization.
Results


Differences (P<0.001) were observed concerning duration of surgery, operative difficulty and quantity of gland removed per minute. Concerning duration of surgery it is shorter for LE followed by TB and then by both FHS and LSJ. Concerning the quantity of thyroid removed per minute LE leads, followed by FHS and TB. The least amount of gland removed per minute is by LSJ. Finally, operative difficulty was less for LE, while it was equal for all other three devices.
Conclusions


Energy devices are now frequently used in thyroidectomy. Comparing these devices seems to qualify them as equal concerning post-operative complications, hemostasis, and acute inflammatory reaction. However, Ligasure TM  Exact Dissector seems to have better results concerning duration of surgery, quantity of thyroid tissue removed per minute and intraoperative difficulty.",2020,"Differences (P<0.001) were observed concerning duration of surgery, operative difficulty and quantity of gland removed per minute.","['total thyroidectomy', 'patients undergoing thyroidectomy', '180 patients']","['Ligasure TM  Exact dissector with other energy devices', 'Ligasure TM  Exact', 'hemostatic device used: Focus Harmonic Scalpel ®  (FHS), Ligasure TM  Small Jaw (LSJ), Thunderbeat ®  (TB), and Ligasure TM  Exact (LE']","['duration of surgery, operative difficulty and quantity of gland removed per minute', 'epidemiologic and biochemical data, operative difficulty, postoperative vocal alteration and pain, complications, operating time, grams of gland excised per minute, and hospitalization']","[{'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0180479', 'cui_str': 'Dissector'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1298904', 'cui_str': 'Device used'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0392220', 'cui_str': 'Scalpel'}, {'cui': 'C0025990', 'cui_str': 'Congenital micrognathism'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C1285092', 'cui_str': 'Gland structure'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",180.0,0.152198,"Differences (P<0.001) were observed concerning duration of surgery, operative difficulty and quantity of gland removed per minute.","[{'ForeName': 'Theodosios S', 'Initials': 'TS', 'LastName': 'Papavramidis', 'Affiliation': 'Unit of Minimally Invasive Endocrine Surgery, Interbalkan Medical Center, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Pliakos', 'Affiliation': 'Unit of Minimally Invasive Endocrine Surgery, Interbalkan Medical Center, Thessaloniki, Greece.'}, {'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Chorti', 'Affiliation': '1st Propedeutic Department of Surgery, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Panidis', 'Affiliation': 'Unit of Minimally Invasive Endocrine Surgery, Interbalkan Medical Center, Thessaloniki, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kotsovolis', 'Affiliation': 'Unit of Minimally Invasive Endocrine Surgery, Interbalkan Medical Center, Thessaloniki, Greece.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Stelmach', 'Affiliation': '1st Propedeutic Department of Surgery, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Koutsoumparis', 'Affiliation': 'Unit of Minimally Invasive Endocrine Surgery, Interbalkan Medical Center, Thessaloniki, Greece.'}, {'ForeName': 'Sohail', 'Initials': 'S', 'LastName': 'Bakkar', 'Affiliation': 'Department of Surgery, Faculty of Medicine, The Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Michalopoulos', 'Affiliation': '1st Propedeutic Department of Surgery, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}]",Gland surgery,['10.21037/gs.2020.02.05']
2158,32416779,Trial and error.,,2020,,[],[],[],[],[],[],,0.0803244,,"[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ofri', 'Affiliation': 'Bellevue Hospital, NYU School of Medicine, New York, NY 10016, USA. Electronic address: danielle.ofri@nyumc.org.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30965-X']
2159,30941887,Micronutrient powder supplements combined with nutrition education marginally improve growth amongst children aged 6-23 months in rural Burkina Faso: A cluster randomized controlled trial.,"Micronutrients powder (MNP) can prevent anaemia amongst children 6-23 months old. However, evidence of an effect on growth is limited and concerns about the safety of iron-containing MNP interventions limits their applicability. In a cluster randomized controlled intervention, we evaluated the effectiveness of a nutritional package including counselling and provision of MNP to improve the nutritional status of children aged 6-23 months and the effect of sustained use of MNP on morbidity in a malaria-endemic area. Child feeding practises and nutritional status were assessed through cross-sectional surveys. Biweekly morbidity surveillance and anthropometry measurements were carried out in a nested cohort study. No significant differences in the prevalence of wasting (-0.7% [-6.8, 5.3] points; p = .805), stunting (+4.6% [-2.9, 12.0] points; p = .201), or mean length-for-age z-score and weight-for-length z-score scores were found between study groups. The proportion of children with a minimum dietary diversity score and those with a minimum acceptable diet significantly increased in the intervention group compared with the control by 6.5% points (p = .043) and 5.8% points (p = .037), respectively. There were no significant differences in the risk of diarrhoea (RR: 1.68, 95% CI [0.94, 3.08]), fever (RR: 1.20 [0.82, 1.77]), and malaria (RR: 0.68 [0.37, 1.26]) between study groups. In the nested study, the rate of linear growth was higher in the intervention than in the control group by 0.013 SD/month (p = .027). In a programmatic intervention, MNP and nutrition education marginally improved child feeding practises and growth, without increasing morbidity from malaria or fever.",2019,"The proportion of children with a minimum dietary diversity score and those with a minimum acceptable diet significantly increased in the intervention group compared with the control by 6.5% points (p = .043) and 5.8% points (p = .037), respectively.","['children aged 6-23\xa0months in rural Burkina Faso', 'children 6-23\xa0months old', 'children aged 6-23\xa0months']","['MNP', 'Micronutrients powder (MNP', 'nutritional package including counselling and provision of MNP', 'Micronutrient powder supplements combined with nutrition education']","['proportion of children with a minimum dietary diversity score', 'fever', 'morbidity from malaria or fever', 'mean length-for-age z-score and weight-for-length z-score scores', 'prevalence of wasting', 'Biweekly morbidity surveillance and anthropometry measurements', 'rate of linear growth', 'risk of diarrhoea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.09083,"The proportion of children with a minimum dietary diversity score and those with a minimum acceptable diet significantly increased in the intervention group compared with the control by 6.5% points (p = .043) and 5.8% points (p = .037), respectively.","[{'ForeName': 'Hermann B', 'Initials': 'HB', 'LastName': 'Lanou', 'Affiliation': 'Ministry of Higher Education, Scientific Research and Innovation, Institut de Recherche en Sciences de la Santé, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Saskia J M', 'Initials': 'SJM', 'LastName': 'Osendarp', 'Affiliation': 'Nutrition International, Ottawa, Ontario, Canada.'}, {'ForeName': 'Alemayehu', 'Initials': 'A', 'LastName': 'Argaw', 'Affiliation': 'Nutrition International, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kirrily', 'Initials': 'K', 'LastName': 'De Polnay', 'Affiliation': 'Child Health and Nutrition Unit, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ouédraogo', 'Affiliation': 'Nutrition International, Ottawa, Ontario, Canada.'}, {'ForeName': 'Seni', 'Initials': 'S', 'LastName': 'Kouanda', 'Affiliation': 'Ministry of Higher Education, Scientific Research and Innovation, Institut de Recherche en Sciences de la Santé, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kolsteren', 'Affiliation': 'Child Health and Nutrition Unit, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.'}]",Maternal & child nutrition,['10.1111/mcn.12820']
2160,29274690,Colonic Mucosal Bacteria Are Associated with Inter-Individual Variability in Serum Carotenoid Concentrations.,"BACKGROUND


Relatively high serum carotenoid levels are associated with reduced risks of chronic diseases, but inter-individual variability in serum carotenoid concentrations is modestly explained by diet. The bacterial community in the colon could contribute to the bioaccessibility of carotenoids by completing digestion of plant cells walls and by modulating intestinal permeability.
OBJECTIVE


To evaluate whether colonic bacterial composition is associated with serum and colon carotenoid concentrations.
DESIGN


The study was a randomized dietary intervention trial in healthy individuals who were at increased risk of colon cancer. Colon mucosal biopsy samples were obtained before and after 6 months of intervention without prior preparation of the bowels.
PARTICIPANTS/SETTING


Participants were recruited from Ann Arbor, MI, and nearby areas from July 2007 to November 2010. Biopsy data were available from 88 participants at baseline and 82 participants after 6 months.
METHODS


Study participants were randomized to counseling for either a Mediterranean diet or a Healthy Eating diet for 6 months.
RESULTS


At baseline, bacterial communities in biopsy samples from study participants in the highest vs the lowest tertile of total serum carotenoid levels differed by several parameters. Linear discriminant analysis effect size identified 11 operational taxonomic units that were significantly associated with higher serum carotenoid levels. In linear regression analyses, three of these accounted for an additional 12% of the variance in serum total carotenoid concentrations after including body mass index, smoking, and dietary intakes in the model. These factors together explained 36% of the inter-individual variance in serum total carotenoid concentrations. The bacterial community in the colonic mucosa, however, was resistant to change after dietary intervention with either a Mediterranean diet or Healthy Eating diet, each of which doubled fruit and vegetable intakes.
CONCLUSIONS


The colonic mucosal bacterial community was associated with serum carotenoid concentrations at baseline but was not appreciably changed by dietary intervention.",2018,The colonic mucosal bacterial community was associated with serum carotenoid concentrations at baseline but was not appreciably changed by dietary intervention.,"['88 participants at baseline and 82 participants after 6 months', 'Participants were recruited from Ann Arbor, MI, and nearby areas from July 2007 to November 2010', 'healthy individuals who were at increased risk of colon cancer']","['Mediterranean diet or a Healthy Eating diet', 'Mediterranean diet or Healthy Eating diet']","['serum carotenoid concentrations', 'total serum carotenoid levels', 'serum total carotenoid concentrations', 'Colon mucosal biopsy samples']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]","[{'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1271752', 'cui_str': 'Serum carotenoid level'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0852695', 'cui_str': 'Mucosal biopsy'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",,0.0178737,The colonic mucosal bacterial community was associated with serum carotenoid concentrations at baseline but was not appreciably changed by dietary intervention.,"[{'ForeName': 'Zora', 'Initials': 'Z', 'LastName': 'Djuric', 'Affiliation': ''}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Bassis', 'Affiliation': ''}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Plegue', 'Affiliation': ''}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'ElKhansa', 'Initials': 'E', 'LastName': 'Sidahmed', 'Affiliation': ''}, {'ForeName': 'D Kim', 'Initials': 'DK', 'LastName': 'Turgeon', 'Affiliation': ''}, {'ForeName': 'Mack T', 'Initials': 'MT', 'LastName': 'Ruffin', 'Affiliation': ''}, {'ForeName': 'Ikuko', 'Initials': 'I', 'LastName': 'Kato', 'Affiliation': ''}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2017.09.013']
2161,32419820,"Effect of Acupuncture on Intraocular Pressure in Glaucoma Patients: A Single-Blinded, Randomized, Controlled Trial.","Glaucoma is characterized by the degeneration of retinal ganglion cells that cause progressive optic neuropathy, finally resulting in changes to the optic nerve head. Lowering intraocular pressure (IOP) is the only method proven for treating glaucoma. Several studies have discovered that acupuncture can reduce IOP and also increase ocular perfusion and ocular blood flow. Therefore, the present study investigated the effect of acupuncture on IOP in glaucoma patients. We conducted a single-blinded, randomized, controlled trial involving 45 glaucoma patients. The results indicated that the difference between the IOP 60 min after the intervention and IOP immediately before the intervention was greater in the acupuncture group (AG) and electroacupuncture group (EG) than in the sham group (SG) for all four of the interventions performed and in both eyes (all  p  < 0.05). The IOP difference between immediately before the first intervention and after finishing the final intervention was also greater in the AG and EG than in the SG in both eyes (all  p  < 0.05). In conclusion, IOP was reduced at 60 min after acupuncture or electroacupuncture was performed at BL1 and EX-HN7. Additionally, IOP was reduced after finishing four acupuncture or electroacupuncture sessions. Therefore, our results suggest that acupuncture and electroacupuncture are beneficial for lowering IOP in glaucoma patients. This trial is registered with NCT04157530.",2020,The IOP difference between immediately before the first intervention and after finishing the final intervention was also greater in the AG and EG than in the SG in both eyes (all  p  < 0.05).,"['Glaucoma Patients', 'glaucoma patients', '45 glaucoma patients']","['acupuncture', 'acupuncture or electroacupuncture', 'electroacupuncture', 'Acupuncture', 'acupuncture and electroacupuncture']","['ocular perfusion and ocular blood flow', 'Lowering intraocular pressure (IOP', 'Intraocular Pressure', 'IOP difference', 'IOP']","[{'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0028841', 'cui_str': 'Hypotony of eye'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",45.0,0.224047,The IOP difference between immediately before the first intervention and after finishing the final intervention was also greater in the AG and EG than in the SG in both eyes (all  p  < 0.05).,"[{'ForeName': 'Shu-Yuan', 'Initials': 'SY', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Chinese Medicine, College of Chinese Medicine, China Medical University, Taichung 40402, Taiwan.'}, {'ForeName': 'Feng-Shuen', 'Initials': 'FS', 'LastName': 'Yieh', 'Affiliation': 'Dashe Shun Ming Eye Clinic, Kaohsiung 815, Taiwan.'}, {'ForeName': 'Wen-Ling', 'Initials': 'WL', 'LastName': 'Liao', 'Affiliation': 'Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung 40402, Taiwan.'}, {'ForeName': 'Tsai-Chung', 'Initials': 'TC', 'LastName': 'Li', 'Affiliation': 'Graduate Institute of Biostatistics, College of Public Health, China Medical University, Taichung 40402, Taiwan.'}, {'ForeName': 'Ching-Liang', 'Initials': 'CL', 'LastName': 'Hsieh', 'Affiliation': 'Chinese Medicine Research Center, China Medical University, Taichung 40402, Taiwan.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/7208081']
2162,32418659,Extracorporeal Shockwave Therapy and Knee Osteoarthritis: Defining a Placebo Group.,,2020,,['and Knee Osteoarthritis'],"['Extracorporeal Shockwave Therapy', 'Placebo']",[],"[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.018528,,"[{'ForeName': 'Goksel', 'Initials': 'G', 'LastName': 'Tanigor', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Faculty of Medicine, Bornova, İzmir, Turkey.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Hepguler', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Faculty of Medicine, Bornova, İzmir, Turkey.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.018']
2163,32418679,The Effect of the Consent Process on Patient Satisfaction With Pain Management: A Randomized Controlled Trial.,"STUDY OBJECTIVE


We aim to determine whether the timing and context of informed consent affects the subjective outcome of patient satisfaction with pain management.
METHODS


We conducted a randomized controlled trial in a single emergency department (ED). Patients aged 18 years or older with a triage pain score of greater than or equal to 4 provided consent to participate in a pain management study. They were randomized to consent in the ED or at follow-up. All patients were followed up at 48 hours post-ED discharge. Patients who consented at follow-up were unaware of the study until cold called. The primary outcome was patient satisfaction with pain management. Secondary analyses examined effects on follow-up and participation rates. Variables associated with patients' being very satisfied were determined with multivariate logistic regression.
RESULTS


Outcome data were obtained on 655 of 825 patients enrolled (79.4%). Patients who provided consent at follow-up were less likely to be very satisfied compared with those who consented in the ED (difference in proportions 11.5%; 95% confidence interval 3.5 to 19.4). Follow-up and participation rates did not differ between the groups. Patients who received pain advice and adequate analgesia (both as defined in this study) were more likely to be very satisfied (odds ratio 5.18, 95% confidence interval 2.82 to 9.52; and odds ratio 1.54, 95% confidence interval 1.07 to 2.22, respectively).
CONCLUSION


The timing and context of informed consent significantly affect the subjective outcome of patient satisfaction, and this should be considered during study design. Clinicians should strive to provide pain advice and adequate analgesia to maximize their patients' satisfaction.",2020,Follow-up and participation rates did not differ between the groups.,"['Patients who consented at follow-up were unaware of the study until cold called', 'patient satisfaction with pain management', 'Patients aged 18 years or older with a triage pain score of greater than or equal to 4 provided consent to participate in a pain management study', 'Patient Satisfaction With Pain Management']",[],"['patient satisfaction with pain management', 'Follow-up and participation rates', 'follow-up and participation rates', 'pain advice and adequate analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439091', 'cui_str': '>='}]",[],"[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}]",825.0,0.169057,Follow-up and participation rates did not differ between the groups.,"[{'ForeName': 'Safire', 'Initials': 'S', 'LastName': 'Valentine', 'Affiliation': 'Eastern Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Majer', 'Affiliation': 'Barwon Health, Geelong, Victoria, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Grant', 'Affiliation': 'Western Health, Footscray, Victoria, Australia.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Ugoni', 'Affiliation': 'Centre for Epidemiology and Biostatistics, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Taylor', 'Affiliation': 'Emergency Department, Austin Health, Heidelberg, and Department of Medicine, University of Melbourne, Parkville, Victoria, Australia. Electronic address: david.taylor@austin.org.au.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.03.029']
2164,31560227,Effects of a Laxation and Probiotic Bowel Preparation Regimen: A Randomized Controlled Trial in Patients Undergoing Prostate Radiation Therapy.,"Aim : To determine the effect of bulking and osmotic laxation regimens on reducing rectal gas in patients receiving external beam radiation therapy for prostate cancer. Methods:  A single blinded randomized controlled trial was conducted. Participants assigned to the intervention group (IG) were instructed to consume a bulking laxative and probiotic and the standard care group (SC) instructed to consume an osmotic laxative. Both groups followed a standard low gas diet. Rectal gas ratings were determined from cone-beam computed tomography (CBCT) scans. Dietary and laxative compliance, bowel habits, fiber and fluid intakes were determined from food diaries. Results:  Demographic characteristics were not significantly different between the two treatment arms. The mean age was 74 years. Participants were randomized into the IG ( n  = 8) and SC group ( n  = 9). Analysis of 433 CBCT scans indicate the odds of a higher rectal gas rating were significantly increased for the IG compared with the SC group (OR 3.2, 95% CI 1.77-5.78,  P  < 0.001). Conclusions:  The osmotic laxative was more effective at achieving lower rectal gas levels than a bulking laxative with probiotic in this study. Larger studies of commonly used laxatives are required to develop recommendations for bowel preparation during radiotherapy to the prostate.",2020,The osmotic laxative was more effective at achieving lower rectal gas levels than a bulking laxative with probiotic in this study.,"['Patients Undergoing Prostate Radiation Therapy', 'patients receiving external beam radiation therapy for prostate cancer', 'The mean age was 74\u2009years']","['intervention group (IG) were instructed to consume a bulking laxative and probiotic and the standard care group (SC) instructed to consume an osmotic laxative', 'bulking and osmotic laxation regimens', 'Laxation and Probiotic Bowel Preparation Regimen']","['higher rectal gas rating', 'Demographic characteristics', 'Rectal gas ratings', 'Dietary and laxative compliance, bowel habits, fiber and fluid intakes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1955900', 'cui_str': 'Bulk Laxatives'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0353980', 'cui_str': 'Osmotic laxatives (product)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake (observable entity)'}]",,0.113742,The osmotic laxative was more effective at achieving lower rectal gas levels than a bulking laxative with probiotic in this study.,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Weston', 'Affiliation': 'Central West Cancer Care Centre, Orange Health Service, Orange, NSW, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Luscombe', 'Affiliation': 'The School of Rural Health, Sydney Medical School, The University of Sydney, Orange, NSW, Australia.'}, {'ForeName': 'Kerith', 'Initials': 'K', 'LastName': 'Duncanson', 'Affiliation': 'Health Education and Training Institute, The Junction, NSW, Australia.'}]",Nutrition and cancer,['10.1080/01635581.2019.1669675']
2165,32416718,Experiences of integrating community volunteers as extensions of the primary care team to help support older adults at home: a qualitative study.,"BACKGROUND


Increasing the integration of community volunteers into primary health care delivery has the potential to improve person-focused, coordinated care, yet the use of volunteers in primary care is largely unexplored. Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) is a multi-component intervention involving trained community volunteers functioning as extensions of primary care teams, supporting care based on older adults' health goals and needs. This study aimed to gain an understanding of volunteer experiences within the program and client and health care provider perspectives on the volunteer role.
METHODS


This study used a qualitative descriptive approach embedded in a pragmatic randomized controlled trial. Participants included Health TAPESTRY volunteers, health care providers, volunteer coordinator, and program clients, all connected to two primary care practice sites in a large urban setting in Ontario, Canada. Data collection included semi-structured focus groups and interviews with all participants, and the completion of a measure of attitudes toward older adults and self-efficacy for volunteers. Qualitative data were inductively coded and analyzed using a constant comparative approach. Quantitative data were summarized using descriptive statistics.
RESULTS


Overall, 30 volunteers and 64 other participants (clients, providers, volunteer coordinator) were included. Themes included: 1. Volunteer training: ""An investment in volunteers""; 2. Intergenerational volunteer pairing: ""The best of both worlds""; 3. Understanding the volunteer role and its scope: ""Lay people involved in care""; 4. Volunteers as extensions of primary care teams: ""Being the eyes where they live""; 5. The disconnect between volunteers and the clinical team: ""Is something being done?""; 6. ""Learning… all the time"": Impacts on volunteers; and 7. Clients' acceptance of volunteers.
CONCLUSIONS


This study showed that it is possible to integrate community volunteers into the primary care setting, adding human connections to deepen the primary care team's understanding of their patients. Program implementation suggestions that emerged included: using role play in training, making volunteer role boundaries and specifications clear, and making efforts to connect volunteers and the primary care team they are supporting. This exploration of stakeholder voices has the potential to help improve volunteer program uptake and acceptability, as well as volunteer recruitment, retention, and training.
TRIAL REGISTRATION


For RCT: https://clinicaltrials.gov/ct2/show/NCT02283723, November 5, 2014.",2020,"Strengthening Quality (Health TAPESTRY) is a multi-component intervention involving trained community volunteers functioning as extensions of primary care teams, supporting care based on older adults' health goals and needs.","['30 volunteers and 64 other participants (clients, providers, volunteer coordinator) were included', 'Intergenerational volunteer pairing: ', 'older adults at home', 'Participants included Health TAPESTRY volunteers, health care providers, volunteer coordinator, and program clients, all connected to two primary care practice sites in a large urban setting in Ontario, Canada', 'Health Teams Advancing Patient Experience', ""volunteers; and 7. Clients' acceptance of volunteers""]","['Strengthening Quality (Health TAPESTRY', 'worlds']",[],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],30.0,0.0198048,"Strengthening Quality (Health TAPESTRY) is a multi-component intervention involving trained community volunteers functioning as extensions of primary care teams, supporting care based on older adults' health goals and needs.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gaber', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada. jgaber@mcmaster.ca.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Oliver', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Valaitis', 'Affiliation': 'School of Nursing, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cleghorn', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Larkin', 'Initials': 'L', 'LastName': 'Lamarche', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Ernie', 'Initials': 'E', 'LastName': 'Avilla', 'Affiliation': 'Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Parascandalo', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dolovich', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}]",BMC family practice,['10.1186/s12875-020-01165-2']
2166,32418785,Value of MRI Radiomics Based on Enhanced T1WI Images in Prediction of Meningiomas Grade.,"OBJECTIVE


Different grades of meningiomas require different treatment strategies and have a different prognosis; thus, the noninvasive classification of meningiomas before surgery is of great importance. The purpose of this study was to explore the application value of magnetic resonance imaging (MRI) radiomics based on enhanced-T1-weighted (T1WI) images in the prediction of meningiomas grade.
MATERIALS AND METHODS


A total of 98 patients with meningiomas who were confirmed by surgical pathology and underwent preoperative routine MRI between January 2017 and December 2019 were analyzed. There were 82 cases of low-grade meningiomas (WHO grade I) and 16 cases of high-grade meningiomas (7 cases of WHO grade II and 9 cases of WHO grade III). These patients were randomly divided into a training group and test group according to 7:3 ratio. The lesions were manually delineated using ITK-SNAP software, and radiomics analysis were performed using the Analysis Kit (AK) software. A total of 396 tumor texture features were extracted. Subsequently, the LASSO algorithm was used to reduce the feature dimensions. Next, a prediction model was constructed using the Logistic Regression method and receiver operator characteristic was used to evaluate the prediction performance of the model.
RESULTS


A radiomics prediction model was constructed based on the selected nine characteristic parameters, which performed well in predicting the meningiomas grade. The accuracy rates in the training group and the test group were respectively 94.3% and 92.9%, the sensitivities were respectively 94.8%, and 91.7%, the specificities were respectively 91.7% and 100%, and the area under the curve values were respectively 0.958 and 0.948.
CONCLUSION


The MRI radiomics method based on enhanced-T1WI images has a good predictive effect on the classification of meningiomas and can provide a basis for planning clinical treatment protocols.",2020,The MRI radiomics method based on enhanced-T1WI images has a good predictive effect on the classification of meningiomas and can provide a basis for planning clinical treatment protocols.,['98 patients with meningiomas who were confirmed by surgical pathology and underwent preoperative routine MRI between January 2017 and December 2019 were analyzed'],['magnetic resonance imaging (MRI) radiomics'],['accuracy rates'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025286', 'cui_str': 'Meningioma'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030669', 'cui_str': 'Surgical Pathology'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}]",98.0,0.0157009,The MRI radiomics method based on enhanced-T1WI images has a good predictive effect on the classification of meningiomas and can provide a basis for planning clinical treatment protocols.,"[{'ForeName': 'Hairui', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': 'Department of Radiology, Huzhou Central Hospital, Huzhou, China.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""Department of Radiology, Jiangxi Provincial People's Hospital, Nanchang 330006, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Radiology, Huzhou Central Hospital, Huzhou, China.'}, {'ForeName': 'Peipei', 'Initials': 'P', 'LastName': 'Pang', 'Affiliation': 'GE Healthcare, Hangzhou, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': ""Department of Radiology, Jiangxi Provincial People's Hospital, Nanchang 330006, China. Electronic address: 26171381@qq.com.""}, {'ForeName': 'Pinggui', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': ""Department of Radiology, Jiangxi Provincial People's Hospital, Nanchang 330006, China.""}, {'ForeName': 'Dongchuang', 'Initials': 'D', 'LastName': 'Guo', 'Affiliation': 'Department of Radiology, Huzhou Central Hospital, Huzhou, China.'}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': ""Department of Radiology, Jiangxi Provincial People's Hospital, Nanchang 330006, China.""}]",Academic radiology,['10.1016/j.acra.2020.03.034']
2167,26990786,Group cell phones are feasible and acceptable for promoting optimal breastfeeding practices in a women's microcredit program in Nigeria.,"As part of a breastfeeding promotion intervention trial in Nigeria, we provided one cell phone per group of 5-7 microcredit clients and instructed the group's cell phone recipient to share weekly breastfeeding voice and text messages with group members. We measured the feasibility and acceptability of using group cell phones by conducting semi-structured exit interviews with 195 microcredit clients whose babies were born during the intervention (target group), in-depth interviews with eight phone recipients and nine non-phone recipients, and 16 focus group discussions with other microcredit clients. Women in the target group said the group phone worked well or very well (64%). They were motivated to try the recommended practices because they trusted the information (58%) and had support from others (35%). Approximately 44% of target women reported that their groups met and shared messages at least once a week. Women in groups that met at least weekly had higher odds of exclusive breastfeeding up to 6 months (OR 5.6, 95% CI 1.6, 19.7) than women in groups that never met. In-depth interviews and focus group discussions indicated that non-phone recipients had positive feelings towards phone recipients, the group phone met participants' needs, and messages were often shared outside the group. In conclusion, group cell phone messaging to promote breastfeeding among microcredit clients is feasible and acceptable and can be part of an effective behaviour change package.",2017,"In-depth interviews and focus group discussions indicated that non-phone recipients had positive feelings towards phone recipients, the group phone met participants' needs, and messages were often shared outside the group.","['195 microcredit clients whose babies were born during the intervention (target group), in-depth interviews with eight phone recipients and nine non-phone recipients, and 16 focus group discussions with other microcredit clients']","[""cell phone per group of 5-7 microcredit clients and instructed the group's cell phone recipient to share weekly breastfeeding voice and text messages with group members""]","['positive feelings', 'feasibility and acceptability']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]","[{'cui': 'C1136359', 'cui_str': 'Cell Phone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0330858,"In-depth interviews and focus group discussions indicated that non-phone recipients had positive feelings towards phone recipients, the group phone met participants' needs, and messages were often shared outside the group.","[{'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Flax', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Alawiyatu Usman', 'Initials': 'AU', 'LastName': 'Ibrahim', 'Affiliation': 'Primary Health Care Department, Bauchi Local Government, Bauchi, Nigeria.'}, {'ForeName': 'Mekebeb', 'Initials': 'M', 'LastName': 'Negerie', 'Affiliation': 'Partners for Development, Silver Spring, Maryland, USA.'}, {'ForeName': 'Danjuma', 'Initials': 'D', 'LastName': 'Yakubu', 'Affiliation': 'Partners for Development, Bauchi, Nigeria.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Leatherman', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Bentley', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12261']
2168,32418770,Comment on: Severe obesity and vitamin D deficiency treatment options before the bariatric surgery: a randomized clinical trial.,,2020,,[],[],[],[],[],[],,0.0865464,,"[{'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Furtado', 'Affiliation': 'Department of Bariatric Surgery, University of Maryland Medical Center, Baltimore, Maryland.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.04.004']
2169,32418680,The effect of nutritional education program on quality of life and serum electrolytes levels in hemodialysis patients: A single-blind randomized controlled trial.,"OBJECTIVE


To determine the effect of nutrition education program on hemodialysis patients' quality of life (QoL) and serum electrolytes levels.
METHODS


This study was a randomized controlled trial in which 94 eligible hemodialysis patients were randomly assigned to intervention (n = 48) and control (n = 46) groups. In the intervention group, the patients were trained in healthy nutrition for four weeks. After two months, samples of both groups completed the Kidney Disease Quality of Life Instrument (KDQOL) and Na, K, P, Ca and Mg levels were also measured and compared.
RESULTS


There were no significant differences in QoL scores and electrolytes between the two groups before intervention (p > 0.05). After intervention the QoL scores in the intervention group were significantly higher than in the control group (p < 0.05). However, after intervention the levels of Na, K, P and Mg in the intervention group were significantly lower than in the control group (p < 0.05). Calcium level was not significantly different between the two groups after intervention (p = 0.16).
CONCLUSION


The results showed that e-learning is effective in improving the QoL and serum electrolytes of hemodialysis patients.
PRACTICE IMPLICATIONS


This paper could serve as support for clinical healthcare professionals to improve patient knowledge and QoL through virtual education methods.",2020,After intervention the QoL scores in the intervention group were significantly higher than in the control group (p < 0.05).,"['94 eligible hemodialysis patients', 'hemodialysis patients']","['nutritional education program', 'nutrition education program']","['QoL scores and electrolytes', 'quality of life and serum electrolytes levels', 'levels of Na, K, P and Mg', ""hemodialysis patients' quality of life (QoL) and serum electrolytes levels"", 'Calcium level', 'QoL and serum electrolytes', 'Kidney Disease Quality of Life Instrument (KDQOL) and Na, K, P, Ca and Mg levels', 'QoL scores']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C1287347', 'cui_str': 'Serum electrolyte levels - finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",94.0,0.0310619,After intervention the QoL scores in the intervention group were significantly higher than in the control group (p < 0.05).,"[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Naseri-Salahshour', 'Affiliation': 'School of Nursing and Midwifery, Saveh University of Medical Sciences, Jomhouri St., Madar Sq. 3918698786 Saveh, Iran. Electronic address: vahidnaseri1994@yahoo.com.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Sajadi', 'Affiliation': 'Clinical Research Development Center of Amiralmomenin Hospital, Arak University of Medical Sciences, Basij Sq., Sardasht Region, 6941738481 Arak, Iran. Electronic address: sajadimahbobeh@yahoo.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Nikbakht-Nasrabadi', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Basij Sq., Sardasht Region, 1419733171 Iran. Electronic address: nikbakht@tums.ac.ir.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Davodabadi', 'Affiliation': 'Clinical Research Development Center of Amiralmomenin Hospital, Arak University of Medical Sciences, Arak, Basij Sq., Sardasht Region, 6941738481 Iran. Electronic address: fahimedavodabady@gmail.com.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fournier', 'Affiliation': 'College of Doctoral Studies, Grand Canyon University, Phoenix, AZ, USA. Electronic address: afournier2@my.gcu.edu.'}]",Patient education and counseling,['10.1016/j.pec.2020.03.021']
2170,32107609,Ramucirumab after prior sorafenib in patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein: Japanese subgroup analysis of the REACH-2 trial.,"BACKGROUND


The global, randomized, phase 3 REACH-2 study (ClinicalTrials.gov identifier: NCT02435433) found significantly longer overall survival (OS) for second-line ramucirumab versus placebo (hazard ratio [HR]: 0.710, 95% confidence interval [CI] 0.531-0.949, P = 0.0199) in patients with advanced hepatocellular carcinoma (HCC) and alpha-fetoprotein (AFP) ≥ 400 ng/mL. This prespecified subgroup analysis evaluated the efficacy and safety of ramucirumab in the Japanese patients enrolled in the study.
METHODS


Patients with advanced HCC and AFP ≥ 400 ng/mL after first-line sorafenib were randomized 2:1 to ramucirumab (8 mg/kg intravenously) or placebo every 2 weeks. Hazard ratios for progression-free survival (PFS) and OS (primary endpoint of the overall study) were estimated using the stratified Cox regression model. We also pooled individual patient data from REACH-2 with data from REACH (NCT01140347) for patients with AFP ≥ 400 ng/mL.
RESULTS


In the Japanese REACH-2 subpopulation, there were improvements for ramucirumab (n = 41) versus placebo (n = 18) in PFS (HR 0.282, 95% CI 0.144-0.553) and OS was numerically prolonged (HR 0.599, 95% CI 0.303-1.187), consistent with the significant benefit seen in the overall REACH-2 study population. In the ramucirumab and placebo arms, respectively, the objective response rate was 7.3% and 0%, and the disease control rate was 70.7% and 33.3%. The most frequently reported grade ≥ 3 treatment-emergent adverse event was hypertension (ramucirumab: 15%; placebo: 11%).
CONCLUSIONS


Ramucirumab after prior sorafenib improved PFS and OS compared with placebo, with a manageable safety profile, in the Japanese REACH-2 subpopulation, consistent with the overall REACH-2 study results. Ramucirumab is the first agent to demonstrate clinical benefit for Japanese patients with HCC in the second-line setting.",2020,"In the Japanese REACH-2 subpopulation, there were improvements for ramucirumab (n = 41) versus placebo (n = 18) in PFS (HR 0.282, 95% CI 0.144-0.553) and OS was numerically prolonged (HR 0.599, 95% CI 0.303-1.187), consistent with the significant benefit seen in the overall REACH-2 study population.","['patients with advanced hepatocellular carcinoma (HCC) and alpha-fetoprotein (AFP)\u2009≥\u2009400', 'patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein', 'Japanese patients enrolled in the study', 'Patients with advanced HCC and AFP\u2009≥', 'patients with AFP\u2009≥\u2009400', 'Japanese patients with HCC in the second-line setting']","['placebo', 'Ramucirumab', 'ramucirumab', 'Ramucirumab after prior sorafenib']","['objective response rate', 'efficacy and safety', 'overall survival (OS', 'Hazard ratios for progression-free survival (PFS) and OS', 'disease control rate', 'PFS and OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0002210', 'cui_str': 'alpha-Fetoproteins'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.561281,"In the Japanese REACH-2 subpopulation, there were improvements for ramucirumab (n = 41) versus placebo (n = 18) in PFS (HR 0.282, 95% CI 0.144-0.553) and OS was numerically prolonged (HR 0.599, 95% CI 0.303-1.187), consistent with the significant benefit seen in the overall REACH-2 study population.","[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan. m-kudo@med.kindai.ac.jp.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Motomura', 'Affiliation': 'Aso Iizuka Hospital, Fukuoka, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Ohno', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Morimoto', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Seo', 'Affiliation': 'Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': 'National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Shinpei', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Kyoundo Hospital, Sasaki Institute, Tokyo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Graduate School of Medicine, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Furukawa', 'Affiliation': 'National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Aramaki', 'Affiliation': 'Shizuoka Cancer Center Hospital, Shizuoka, Japan.'}, {'ForeName': 'Seijin', 'Initials': 'S', 'LastName': 'Nadano', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Ohkawa', 'Affiliation': 'Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Kudo', 'Affiliation': 'Graduate School of Medicine, Osaka University, Osaka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Kyorin University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Takai', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Gosuke', 'Initials': 'G', 'LastName': 'Homma', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Reigetsu', 'Initials': 'R', 'LastName': 'Yoshikawa', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.'}]",Journal of gastroenterology,['10.1007/s00535-020-01668-w']
2171,32416780,"Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial.","BACKGROUND


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


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


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


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


F Hoffmann-La Roche and Genentech.",2020,"Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24).","['0·82', 'patients with metastatic urothelial carcinoma', 'Between July 15, 2016, and July 20, 2018, we enrolled 1213 patients', 'metastatic urothelial cancer (IMvigor130', 'first-line metastatic urothelial carcinoma', 'untreated patients aged 18 years or older with locally advanced or metastatic urothelial carcinoma, from 221 sites in 35 countries', 'metastatic urothelial carcinoma']","['atezolizumab to platinum-based chemotherapy', 'carboplatin (area under the curve of 4·5 mg/mL per min administered intravenously) or cisplatin', 'Atezolizumab', 'atezolizumab', 'atezolizumab with or without platinum-based chemotherapy versus placebo plus platinum-based chemotherapy', 'IMvigor130', 'atezolizumab plus platinum-based chemotherapy', 'gemcitabine', 'placebo plus platinum-based chemotherapy', 'Atezolizumab with or without chemotherapy', 'atezolizumab monotherapy', 'placebo']","['Median overall survival', 'median progression-free survival', 'Adverse events', 'overall survival', 'time of final progression-free survival analysis and interim overall survival analysis', 'intention-to-treat population were investigator-assessed Response Evaluation Criteria in Solid Tumours 1.1 progression-free survival and overall survival', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C4517491', 'cui_str': '1.1'}]",1213.0,0.469836,"Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24).","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Galsky', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY, USA. Electronic address: matthew.galsky@mssm.edu.'}, {'ForeName': 'José Ángel Arranz', 'Initials': 'JÁA', 'LastName': 'Arija', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Eastern Health, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'De Santis', 'Affiliation': 'Charité University Hospital, Berlin, Germany; Department of Urology, Medical University, Vienna, Austria.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kikuchi', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Garcia-Del-Muro', 'Affiliation': 'Catalan Institute of Oncology, IDIBELL, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, Meldola, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Mencinger', 'Affiliation': 'Institute of Oncology Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Izumi', 'Affiliation': 'Kanazawa University Hospital, Kanazawa, Japan.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Panni', 'Affiliation': 'Istituti Ospitalieri Cremona, Cremona, Italy.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gumus', 'Affiliation': 'Istanbul Medeniyet University, Goztepe Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Arash Rezazadeh', 'Initials': 'AR', 'LastName': 'Kalebasty', 'Affiliation': 'Norton Cancer Institute, Louisville, KY, USA.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Sungkyunkwan University Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'P Herzen Oncology Research Institute, Moscow, Russia.'}, {'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Schutz', 'Affiliation': 'Beneficencia Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jian-Ri', 'Initials': 'JR', 'LastName': 'Li', 'Affiliation': 'Taichung Veterans General Hospital, HungKuang University, Taichung, Taiwan.'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Bernhard', 'Affiliation': 'Roche, Welwyn Garden City, UK.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Tayama', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Mariathasan', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Almut', 'Initials': 'A', 'LastName': 'Mecke', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'AnnChristine', 'Initials': 'A', 'LastName': 'Thåström', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Grande', 'Affiliation': 'MD Anderson Cancer Center Madrid, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30230-0']
2172,32418845,Association between Patient-Reported Outcomes and Time to Late Age-Related Macular Degeneration in the Laser Intervention in Early Stages of Age-Related Macular Degeneration Study.,"PURPOSE


To investigate the relationship between patient-reported outcome (PRO) questionnaire responses and time to late age-related macular degeneration (AMD; neovascular AMD [nAMD] or multimodal imaging [MMI]-defined atrophy) among individuals with bilateral large drusen, and the prognostic value of baseline PROs for 36-month AMD status.
DESIGN


Exploratory analyses from a multicenter randomized controlled trial of an AMD intervention (Australian New Zealand Clinical Trials Registry identifier, ACTRN12612000704897).
PARTICIPANTS


Sham treatment group of the Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) Study (n = 141; age, 50-88 years; 77% female).
METHODS


The 28-item Impact of Vision Impairment (IVI-28) and 10-item Night Vision Questionnaire (NVQ-10) were administered at the baseline visit. The PRO scores were derived using rating scale models. Multivariate Cox regression adjusting for demographics and clinical measures of vision (low-luminance visual acuity, low-luminance deficit, and microperimetric sensitivity) from the poorer-performing eye was used to investigate the association between PRO scores and time to late AMD in either eye. Multivariate competing-risk regression was used to estimate cause-specific subhazard ratios for nAMD and atrophy in either eye. Cross-validated logistic lasso models were used to estimate the predicted probability of AMD at 36 months. The area under the receiver operating characteristic curve was assessed to compare prognostic accuracy between models with and without PROs.
MAIN OUTCOME MEASURE


Time until nAMD or atrophy in either eye.
RESULTS


The PRO scores were skewed toward higher functional vision. Higher IVI-28 scores were associated with a lower risk of progression to MMI-defined atrophy (20 events: adjusted hazard ratio, 0.65/logit increase; P = 0.002) but not nAMD (10 events; P = 0.562). Insufficient evidence was found of an association between NVQ-10 score and rate of progression to late AMD (P ≥0.149). Baseline IVI-28 scores were found to contribute to the prognosis of atrophy at the 36-month visit (P = 0.010).
CONCLUSIONS


On average, PROs were associated with an increased risk of progression from intermediate AMD to MMI-defined atrophy. Continuing development of instruments to record PROs in the early stages of AMD have the potential to produce inexpensive and efficient tools to assist in the assessment of disease severity and risk of AMD progression.",2020,"Baseline IVI-28 scores were found to contribute to the prognosis of atrophy at the 36-month visit (P = 0.010).
","['individuals with bilateral large drusen', 'in Early Stages of Age-Related Macular Degeneration (LEAD) Study (n\xa0= 141; age, 50-88 years; 77% female']","['multimodal imaging [MMI]-defined atrophy', 'Laser Intervention', 'AMD intervention']","['NVQ-10 score and rate of progression to late AMD', 'PRO scores and time to late AMD', 'Higher IVI-28 scores', '28-item Impact of Vision Impairment (IVI-28) and 10-item Night Vision Questionnaire (NVQ-10', 'PRO scores', 'Time until nAMD or atrophy in either eye', 'Baseline IVI-28 scores', 'vision (low-luminance visual acuity, low-luminance deficit, and microperimetric sensitivity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0035312', 'cui_str': 'Retinal drusen'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1513743', 'cui_str': 'Imaging, Multimodal'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1621368', 'cui_str': 'Drip Infusions'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}, {'cui': 'C0010985', 'cui_str': 'Dark adaptation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0234684', 'cui_str': 'Luminance'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",141.0,0.0309192,"Baseline IVI-28 scores were found to contribute to the prognosis of atrophy at the 36-month visit (P = 0.010).
","[{'ForeName': 'Myra B', 'Initials': 'MB', 'LastName': 'McGuinness', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Centre for Biostatistics and Epidemiology, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. Electronic address: myra.mcguinness@unimelb.edu.au.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Finger', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Chi D', 'Initials': 'CD', 'LastName': 'Luu', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Fred K', 'Initials': 'FK', 'LastName': 'Chen', 'Affiliation': 'Centre for Ophthalmology and Visual Science (incorporating Lions Eye Institute), The University of Western Australia, Crawley, Australia, Department of Ophthalmology, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Jenifer J', 'Initials': 'JJ', 'LastName': 'Arnold', 'Affiliation': 'Marsden Eye Research, Sydney, Australia.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': 'Belfast Health and Social Care Trust, Belfast, United Kingdom.'}, {'ForeName': 'Robyn H', 'Initials': 'RH', 'LastName': 'Guymer', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2020.03.015']
2173,32418969,Comparison of the Transdermal Bisoprolol Patch with Oral Bisoprolol Fumarate Administration as a Therapeutic Agent for Idiopathic Frequent Premature Ventricular Contractions.,"The transdermal bisoprolol patch (TB) was designed to maintain a sustained concentration of bisoprolol in plasma by a higher trough concentration than oral bisoporolol (OB). We compared the efficacy between TB and OB in patients with idiopathic premature ventricular contractions (PVCs) while considering their duration of action.A total of 78 patients with a PVC count of ≥ 3,000 beats/24 hours were divided into groups treated with TB 4 mg (n = 43) or OB 2.5 mg (n = 35). PVCs were divided into positive heart rate (HR) -dependent PVCs (P-PVCs) and non-positive HR-dependent PVCs (NP-PVCs) based on the relationship between the hourly PVC density and hourly mean HR. Twenty-four-hour Holter electrocardiograms were performed before and 1 to 3 months after the initiation of therapy.There were no significant between-group differences in the baseline characteristics. Both the TB (from 14.6 [9.9-19.2] to 7.6 [1.7-15.8]%, P < 0.001) and OB (from 13.2 [7.6-21.9] to 4.6 [0.5-17.0]%, P = 0.0041) significantly decreased the PVC density, and there was no significant difference between the two groups (P = 0.73). Compared to OB, the TB had similar effects in reducing the PVC density for P-PVCs (P = 0.96), and NP-PVCs (P = 0.71). The TB significantly decreased the P-PVC density from baseline not only during day-time (P < 0.001) but also night-time (P = 0.0017), while the OB did not significantly decrease the P-PVC density from baseline during night-time (P = 0.17).Compared to OB, the TB could be used with the same efficacy of reducing idiopathic PVCs. The TB may be a more useful therapeutic agent than OB for P-PVCs during a 24-hour period.",2020,"The TB significantly decreased the P-PVC density from baseline not only during day-time (P < 0.001) but also night-time (P = 0.0017), while the OB did not significantly decrease the P-PVC density from baseline during night-time (P = 0.17).Compared to OB, the TB could be used with the same efficacy of reducing idiopathic PVCs.","['Idiopathic Frequent Premature Ventricular Contractions', 'patients with idiopathic premature ventricular contractions (PVCs', '78 patients with a PVC count of ≥ 3,000 beats/24 hours']","['transdermal bisoprolol patch (TB', 'Transdermal Bisoprolol Patch with Oral Bisoprolol Fumarate Administration', 'TB']","['night-time', 'positive heart rate (HR) -dependent', 'PVC density', 'P-PVC density', 'OB']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032624', 'cui_str': 'Polyvinyl chloride'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439227', 'cui_str': 'hour'}]","[{'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0543473', 'cui_str': 'Bisoprolol fumarate'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0032624', 'cui_str': 'Polyvinyl chloride'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",78.0,0.0220977,"The TB significantly decreased the P-PVC density from baseline not only during day-time (P < 0.001) but also night-time (P = 0.0017), while the OB did not significantly decrease the P-PVC density from baseline during night-time (P = 0.17).Compared to OB, the TB could be used with the same efficacy of reducing idiopathic PVCs.","[{'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Shinohara', 'Affiliation': 'Department of Cardiovascular Medicine, Toho University Faculty of Medicine.'}, {'ForeName': 'Ryou', 'Initials': 'R', 'LastName': 'Wada', 'Affiliation': 'Department of Cardiovascular Medicine, Toho University Faculty of Medicine.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Department of Cardiovascular Medicine, Toho University Faculty of Medicine.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Yano', 'Affiliation': 'Department of Cardiovascular Medicine, Toho University Faculty of Medicine.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Akitsu', 'Affiliation': 'Department of Cardiovascular Medicine, Toho University Faculty of Medicine.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Koike', 'Affiliation': 'Department of Cardiovascular Medicine, Toho University Faculty of Medicine.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Cardiovascular Medicine, Toho University Faculty of Medicine.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Yuzawa', 'Affiliation': 'Department of Cardiovascular Medicine, Toho University Faculty of Medicine.'}, {'ForeName': 'Takeya', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiovascular Medicine, Toho University Faculty of Medicine.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Fujino', 'Affiliation': 'Department of Cardiovascular Medicine, Toho University Faculty of Medicine.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Ikeda', 'Affiliation': 'Department of Cardiovascular Medicine, Toho University Faculty of Medicine.'}]",International heart journal,['10.1536/ihj.19-643']
2174,32418801,Primary Care Cluster RCT to Increase Diabetes Prevention Program Referrals.,"INTRODUCTION


The Diabetes Prevention Program, an intensive lifestyle change program, effectively reduces the risk of progression from prediabetes to type 2 diabetes but is underutilized. An implementation study using formative research was undertaken to increase Diabetes Prevention Program referrals at a primary care clinic.
STUDY DESIGN


A pragmatic, cluster randomized, mixed-methods study.
SETTING/PARTICPANTS


Clusters were teams of primary care clinicians from 2 primary care clinics. The 3 intervention clusters had 8-11 clinicians, and the 3 control clusters had 7-20 clinicians.
INTERVENTION


Implementation activities occurred from December 2017 to February 2019. The activities included targeted clinician education, a prediabetes clinician champion, and a custom electronic health record report identifying patients with prediabetes.
MAIN OUTCOME MEASURES


The primary outcome was referral of patients with prediabetes to the institutional Diabetes Prevention Program. Study data, including patient demographic and clinical variables, came from electronic health record. Interviews with clinicians evaluated the implementation strategies. Generalized estimating equation analyses that accounted for multiple levels of correlation and interview content analysis occurred in 2019.
RESULTS


Study clinicians cared for 2,992 patients with a prediabetes diagnosis or HbA1c indicative of prediabetes (5.7%-6.4%). Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730). When adjusted for patient age, sex, race, HbA1c value, HbA1c test location, and insurance type, intervention clinicians had 3.85 (95% CI=0.40, 36.78) greater odds of referring a patient with prediabetes to the Diabetes Prevention Program. The 11 interviewed intervention clinicians had mixed opinions about the utility of the interventions, reporting the prediabetes clinic champion (n=7, 64%) and educational presentations (n=6, 55%) as most helpful.
CONCLUSIONS


Intervention clinicians were more likely to make Diabetes Prevention Program referrals; however, the study lacked power to achieve statistical significance. Clinician interviews suggested that intervention components that triggered Diabetes Prevention Program referrals varied among clinicians.",2020,"Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730).","['Diabetes Prevention Program referrals at a primary care clinic', 'Clusters were teams of primary care clinicians from 2 primary care clinics', '2,992 patients with a prediabetes diagnosis or HbA1c indicative of prediabetes (5.7%-6.4']",[],['referral of patients with prediabetes to the institutional Diabetes Prevention Program'],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517822', 'cui_str': '6.4'}]",[],"[{'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",2992.0,0.0201638,"Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730).","[{'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Keck', 'Affiliation': 'Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, Kentucky; Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, Kentucky. Electronic address: james.keck@uky.edu.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Roper', 'Affiliation': 'Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, Kentucky.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Hieronymus', 'Affiliation': 'University of Kentucky Barnstable Brown Diabetes Center, Lexington, Kentucky; University of Kentucky College of Nursing, Lexington, Kentucky.'}, {'ForeName': 'Alisha R', 'Initials': 'AR', 'LastName': 'Thomas', 'Affiliation': 'Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, Kentucky.'}, {'ForeName': 'Zhengyuan', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Biostatistics, University of Kentucky College of Public Health, Lexington, Kentucky.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Westgate', 'Affiliation': 'Department of Biostatistics, University of Kentucky College of Public Health, Lexington, Kentucky.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Fowlkes', 'Affiliation': 'University of Kentucky Barnstable Brown Diabetes Center, Lexington, Kentucky.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cardarelli', 'Affiliation': 'Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, Kentucky.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.02.008']
2175,32418856,Effect of topical tranexamic acid on post-traumatic elbow stiffness in patients treated with open arthrolysis: a prospective comparative study.,"BACKGROUND


Elbow joint open arthrolysis is an effective method to release contracted tissue and débride heterotopic ossification in cases of post-traumatic elbow stiffness. Recurrence remains one of the most common concerns for surgeons. Soft tissue contracture may result from intra- and/or extra-articular bleeding, edema, effusion, and granulation. The increasing incidence of intraoperative and postoperative bleeding has caused uncertainty about surgical outcomes. Tranexamic acid (TXA) is effective for reducing surgery-related bleeding and effusions in total hip or knee arthroplasty.
PURPOSE


To investigate whether topical TXA can decrease blood loss and effusions in patients treated with elbow joint open arthrolysis and whether it affects final function.
PATIENTS AND METHOD


A prospective comparative study was conducted. Sixty-one patients with joint stiffness were enrolled and randomly divided into 2 groups: one consisting of 31 patients treated with topical TXA intraoperatively after open arthrolysis (experimental group) and the other consisting of 30 patients who received saline administration (control group). The operation time, tourniquet time, and intraoperative blood loss were recorded. Drainage volume, elbow rotation, elbow motion arc, Mayo Elbow Performance Score, and operation-related complications were followed up and recorded, whereas hematoma volume remaining in the joint space after drainage tube removal was assessed on ultrasonography.
RESULTS


Tourniquet time, intraoperative blood loss, and postoperative drainage were significantly lower in the TXA group than in the control group. However, no significant intergroup differences were found in the incidence of related complications and final function evaluated at the final follow-up.
CONCLUSION


Topical TXA improves surgical quality by controlling intraoperative bleeding, decreases the amount of blood loss soon after surgery, and could become a routine procedure in elbow joint open arthrolysis.",2020,"Tranexamic acid (TXA) is effective for reducing surgery-related bleeding and effusions in total hip or knee arthroplasty.
","['patients treated with elbow joint open arthrolysis', 'Sixty-one patients with joint stiffness', 'patients treated with open arthrolysis']","['TXA', 'topical TXA', 'Topical TXA', 'Tranexamic acid (TXA', 'topical TXA intraoperatively after open arthrolysis (experimental group)\xa0and the other consisting of 30 patients who received saline administration (control group', 'topical tranexamic acid']","['operation time, tourniquet time, and intraoperative blood loss', 'Drainage volume, elbow rotation, elbow motion arc, Mayo Elbow Performance Score, and operation-related complications', 'Tourniquet time, intraoperative blood loss, and postoperative drainage', 'surgical quality', 'post-traumatic elbow stiffness', 'blood loss and effusions', 'incidence of related complications and final function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013770', 'cui_str': 'Elbow joint structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1283023', 'cui_str': 'Arthrolysis'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1283023', 'cui_str': 'Arthrolysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428724', 'cui_str': 'Duration of tourniquet inflation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0239272', 'cui_str': 'Elbow stiff'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",61.0,0.0156237,"Tranexamic acid (TXA) is effective for reducing surgery-related bleeding and effusions in total hip or knee arthroplasty.
","[{'ForeName': 'Baokun', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated No. 6 People's Hospital, Shanghai, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated No. 6 People's Hospital, Shanghai, China.""}, {'ForeName': 'Jianguang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated No. 6 People's Hospital, Shanghai, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated No. 6 People's Hospital, Shanghai, China. Electronic address: dingjian12187@163.com.""}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.02.010']
2176,32419117,Emotion Regulation among Children in Foster Care Versus Birth Parent Care: Differential Effects of an Early Home-Visiting Intervention.,"Children involved with Child Protective Services (CPS) often show worse emotion regulation than non-involved children, with downstream effects on adaptive functioning. The current study uses two randomized control trials, one conducted with foster caregivers and one conducted with birth parents, to investigate the longitudinal effects of caregiver type (foster versus birth parent) and a home-visiting parenting intervention on emotion regulation among young children referred to CPS. Participants were 211 children referred to CPS during infancy or toddlerhood, of whom 120 remained with their birth parents and 91 were placed in foster care. Caregivers were randomly assigned to receive Attachment and Biobehavioral Catch-Up (ABC), a 10-session intervention designed to promote nurturing, sensitive, and non-intrusive caregiving, or a control intervention. Caregiver type moderated the effects of ABC on young children's observed anger dysregulation during a frustrating task at age 2 to 3 years. Among children remaining with their birth parents, children whose caregivers received ABC showed lower anger dysregulation than children whose caregivers received the control intervention. Children placed in foster care showed lower anger dysregulation than children with birth parents regardless of parenting intervention, and additionally showed higher adaptive regulation than children remaining with their birth parents. Adaptive regulation was not significantly associated with parenting intervention or the caregiver by intervention interaction. Results suggest that foster care placement may be protective for emerging emotion regulation skills among young children referred to CPS, and an attachment-based parenting intervention buffers risks of remaining in the home for young children's emotion dysregulation.",2020,"Children involved with Child Protective Services (CPS) often show worse emotion regulation than non-involved children, with downstream effects on adaptive functioning.","['young children', 'children remaining with their birth parents', 'young children referred to CPS', 'Versus Birth Parent Care', 'Participants were 211 children referred to CPS during infancy or toddlerhood, of whom 120 remained with their birth parents and 91 were placed in foster care', 'foster caregivers and one conducted with birth parents', 'Children in Foster Care']","['Attachment and Biobehavioral Catch-Up (ABC), a 10-session intervention designed to promote nurturing, sensitive, and non-intrusive caregiving, or a control intervention', 'ABC', 'Child Protective Services (CPS', 'Early Home-Visiting Intervention', 'caregiver type (foster versus birth parent) and a home-visiting parenting intervention']","['emotion regulation skills', 'anger dysregulation', 'Emotion Regulation', 'adaptive regulation', 'Adaptive regulation']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C3178496', 'cui_str': 'AM 211'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0580719', 'cui_str': 'Child in foster care'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",211.0,0.0309807,"Children involved with Child Protective Services (CPS) often show worse emotion regulation than non-involved children, with downstream effects on adaptive functioning.","[{'ForeName': 'Madelyn H', 'Initials': 'MH', 'LastName': 'Labella', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, 108 Wolf Hall, Newark, DE, 19716, USA. mlabella@udel.edu.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lind', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Tabitha', 'Initials': 'T', 'LastName': 'Sellers', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, 108 Wolf Hall, Newark, DE, 19716, USA.'}, {'ForeName': 'Caroline K P', 'Initials': 'CKP', 'LastName': 'Roben', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, 108 Wolf Hall, Newark, DE, 19716, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, 108 Wolf Hall, Newark, DE, 19716, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00653-4']
2177,32419119,The Effectiveness and Cost-effectiveness of a Parenting Intervention Integrated with Primary Health Care on Early Childhood Development: a Cluster-Randomized Controlled Trial.,"Developing countries require interventions that can sustainably improve early childhood development (ECD) at scale because hundreds of millions of children are at risk of poor development. This study examined the effectiveness and cost-effectiveness of a parenting intervention integrated with primary health care in terms of ECD. A cluster-randomized controlled trial was conducted in 20 urban communities in China, with 82 and 86 children aged 1-2 months enrolled in the intervention and control groups, respectively, and 71 and 69 children, respectively, followed to 14 months of age. All children in both groups received routine primary health care services. Intervention caregivers received a parenting pamphlet and two parenting training sessions during well-child clinic visits; those with children with suspected developmental delay received additional parenting guidance by telephone. Compared with controls, children receiving the intervention had similar developmental outcomes, measured with the Chinese version of the Ages & Stages Questionnaires third edition (ASQ-C), at baseline, but had significantly higher communication (adjusted mean difference = 0.26; 95% CI 0.03, 0.51), fine motor (adjusted mean difference = 0.19; 95% CI 0.01, 0.37), and overall (adjusted mean difference = 0.25; 95% CI 0.10, 0.41) ASQ-C z-scores after 12 months of the intervention. The intervention cost per child was $50.87, and the costs for increasing the communication, fine motor, and overall ASQ-C scores by one SD were $195.65, $267.74, and $203.48, respectively. Our findings indicate that the integration of a parenting intervention with existing primary health care is a cost-effective way to improve ECD.",2020,"Compared with controls, children receiving the intervention had similar developmental outcomes, measured with the Chinese version of the Ages & Stages Questionnaires third edition (ASQ-C), at baseline, but had significantly higher communication (adjusted mean difference = 0.26; 95% CI 0.03, 0.51), fine motor (adjusted mean difference = 0.19; 95% CI 0.01, 0.37), and overall (adjusted mean difference = 0.25; 95% CI 0.10, 0.41) ASQ-C z-scores after 12 months of the intervention.","['20 urban communities in China, with 82 and 86 children aged 1-2\xa0months enrolled in the intervention and control groups, respectively, and 71 and 69 children, respectively, followed to 14\xa0months of age']","['parenting pamphlet and two parenting training sessions during well-child clinic visits; those with children with suspected developmental delay received additional parenting guidance by telephone', 'routine primary health care services', 'Parenting Intervention Integrated with Primary Health Care', 'parenting intervention integrated with primary health care']","['costs for increasing the communication, fine motor, and overall ASQ-C scores', 'Chinese version of the Ages & Stages Questionnaires third edition (ASQ-C', 'fine motor', 'effectiveness and cost-effectiveness', 'Effectiveness and Cost-effectiveness']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0424605', 'cui_str': 'Developmental delay'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.116487,"Compared with controls, children receiving the intervention had similar developmental outcomes, measured with the Chinese version of the Ages & Stages Questionnaires third edition (ASQ-C), at baseline, but had significantly higher communication (adjusted mean difference = 0.26; 95% CI 0.03, 0.51), fine motor (adjusted mean difference = 0.19; 95% CI 0.01, 0.37), and overall (adjusted mean difference = 0.25; 95% CI 0.10, 0.41) ASQ-C z-scores after 12 months of the intervention.","[{'ForeName': 'Huifeng', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, 168 Litang Road, Changping District, Beijing, 102218, China. lixuejun0627@163.com.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'China Center for Health Development Studies (CCHDS), Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Jingxu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, 38 Xueyuan Road, Haidian District, Beijing, 100191, China. xlwang@bjmu.edu.cn.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01126-2']
2178,32419281,Effects of soy isoflavones on serum systemic and vascular inflammation markers and oxidative stress in peritoneal dialysis patients: A randomized controlled trial.,"Cardiovascular disease (CVD) is common in peritoneal dialysis (PD) patients. This study was designed to investigate the effects of isoflavones on systemic and vascular inflammation markers and oxidative stress in PD patients. In this randomized clinical trial, 40 PD patients were randomly assigned to either the isoflavone or the placebo group. The isoflavone group received 100 mg soy isoflavones daily for 8 weeks, whereas the placebo group received corresponding placebos. At baseline and the end of eighth week, serum high sensitive C-reactive protein (hs-CRP), intercellular adhesion molecule type 1 (ICAM-1), vascular cell adhesion molecule type 1 (VCAM-1), E-selectin, and malondialdehyde were measured. Serum VCAM-1 decreased significantly in the isoflavone group at the end of Week 8 compared to baseline (p = .01), whereas no significant change was observed in the placebo group. Serum ICAM-1 decreased significantly in the isoflavone (p = .01) and placebo (p = .01) group compared to baseline. However, the reduction of ICAM-1 was significantly higher in the isoflavone group than in the placebo group (p = .02). There were no significant differences between the two groups in mean changes of serum E-selectin, malondialdehyde, and hs-CRP. This study indicates that isoflavones reduce serum VCAM-1 and ICAM-1, which are two CVD risk factors, in PD patients.",2020,"There were no significant differences between the two groups in mean changes of serum E-selectin, malondialdehyde, and hs-CRP.","['peritoneal dialysis (PD) patients', 'PD patients', 'peritoneal dialysis patients', '40 PD patients']","['100\u2009mg soy isoflavones', 'isoflavones', 'placebos', 'isoflavone', 'soy isoflavones', 'placebo']","['mean changes of serum E-selectin, malondialdehyde, and hs-CRP', 'Serum VCAM-1', 'serum systemic and vascular inflammation markers and oxidative stress', 'reduction of ICAM-1', 'systemic and vascular inflammation markers and oxidative stress', 'serum high sensitive C-reactive protein (hs-CRP), intercellular adhesion molecule type 1 (ICAM-1), vascular cell adhesion molecule type 1 (VCAM-1), E-selectin, and malondialdehyde', 'Cardiovascular disease (CVD', 'Serum ICAM-1']","[{'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4076257', 'cui_str': 'Soy isoflavone'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",40.0,0.413522,"There were no significant differences between the two groups in mean changes of serum E-selectin, malondialdehyde, and hs-CRP.","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yari', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Tabibi', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Iraj', 'Initials': 'I', 'LastName': 'Najafi', 'Affiliation': 'Department of Nephrology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Movahedian', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6729']
2179,32418922,A breathing movement sensor for chest radiography during inspiration in children aged less than 3 years: a prospective randomized controlled study.,"Chest radiographs should be obtained at the peak of inspiration so that radiological findings can be precisely interpreted. However, this is not easily achieved, particularly in young children who do not follow the instruction to hold their breath. We developed a sensor that detects the breathing movements and conducted a randomized controlled study to determine whether the sensor would increase the proportion of chest radiographs obtained in the inspiration phase. We recruited 124 infants and children aged less than 3 years, who visited the pediatric department of a general hospital in Tokyo, Japan, and allocated them into one of two groups: with-sensor and without-sensor groups. Overall, 81% of all images were obtained during inspiration. The proportion of chest radiographs taken during inspiration was not statistically different between the two groups (81% vs. 82%). In the with-sensor group, radiologic technologists were able to obtain chest radiographs of the same quality while not observing the chest movement, but the sensor. The use of the sensor did not increase the proportion of chest radiographs taken in the inspiration phase in this study. However, this null result may indicate the possibility of utilizing the sensor for automatizing chest radiography in the future.",2020,The proportion of chest radiographs taken during inspiration was not statistically different between the two groups (81% vs. 82%).,"['young children', '124 infants and children aged less than 3 years, who visited the pediatric department of a general hospital in Tokyo, Japan, and allocated them into one of two groups: with-sensor and without-sensor groups', 'children aged less than 3 years']",[],"['proportion of chest radiographs taken during inspiration', 'proportion of chest radiographs']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]",124.0,0.0201476,The proportion of chest radiographs taken during inspiration was not statistically different between the two groups (81% vs. 82%).,"[{'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Honda', 'Affiliation': 'Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Rei', 'Initials': 'R', 'LastName': 'Haruyama', 'Affiliation': 'Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Sugiura', 'Affiliation': 'Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Ohara', 'Affiliation': 'Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Mochigi', 'Affiliation': 'Department of Radiological Physics and Technology, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuzuru', 'Initials': 'Y', 'LastName': 'Kono', 'Affiliation': 'Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Shichino', 'Affiliation': 'Department of Pediatrics, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideko', 'Initials': 'H', 'LastName': 'Uryu', 'Affiliation': 'Department of Pediatrics, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Mizoue', 'Affiliation': 'Department of Epidemiology and Prevention, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Terumi', 'Initials': 'T', 'LastName': 'Marutani', 'Affiliation': 'Department of Clinical Trial Management, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ebihara', 'Affiliation': 'Department of Clinical Trial Management, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Fumiya', 'Initials': 'F', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Radiology, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Makise', 'Affiliation': 'Department of Radiology, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Hidechika', 'Initials': 'H', 'LastName': 'Akashi', 'Affiliation': 'Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo, Japan.'}]",Bioscience trends,['10.5582/bst.2020.03024']
2180,32419245,Prediction of the output factor using machine and deep learning approach in uniform scanning proton therapy.,"PURPOSE


The purpose of this work is to develop machine and deep learning-based models to predict output and MU based on measured patient quality assurance (QA) data in uniform scanning proton therapy (USPT).
METHODS


This study involves 4,231 patient QA measurements conducted over the last 6 years. In the current approach, output and MU are predicted by an empirical model (EM) based on patient treatment plan parameters. In this study, two MATLAB-based machine and deep learning algorithms - Gaussian process regression (GPR) and shallow neural network (SNN) - were developed. The four parameters from patient QA (range, modulation, field size, and measured output factor) were used to train these algorithms. The data were randomized with a training set containing 90% and a testing set containing remaining 10% of the data. The model performance during training was accessed using root mean square error (RMSE) and R-squared values. The trained model was used to predict output based on the three input parameters: range, modulation, and field size. The percent difference was calculated between the predicted and measured output factors. The number of data sets required to make prediction accuracy of GPR and SNN models' invariable was also evaluated.
RESULTS


The prediction accuracy of machine and deep learning algorithms is higher than the EM. The output predictions with [GPR, SNN, and EM] within ± 2% and ± 3% difference were [97.16%, 97.64%, and 92.95%] and [99.76%, 99.29%, and 97.18%], respectively. The GPR model outperformed the SNN with a smaller number of training data sets.
CONCLUSION


The GPR and SNN models outperformed the EM in terms of prediction accuracy. Machine and deep learning algorithms predicted the output factor and MU for USPT with higher predictive accuracy than EM. In our clinic, these models have been adopted as a secondary check of MU or output factors.",2020,The GPR and SNN models outperformed the EM in terms of prediction accuracy.,"['4,231 patient QA measurements conducted over the last 6\xa0years']",['scanning proton therapy (USPT'],"['patient QA (range, modulation, field size, and measured output factor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0436226', 'cui_str': 'Proton therapy'}, {'cui': 'C0205375', 'cui_str': 'Uniform'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0204709', 'cui_str': 'Measuring output'}]",,0.0491469,The GPR and SNN models outperformed the EM in terms of prediction accuracy.,"[{'ForeName': 'Hardev S', 'Initials': 'HS', 'LastName': 'Grewal', 'Affiliation': 'Oklahoma Proton Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Chacko', 'Affiliation': 'Oklahoma Proton Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Salahuddin', 'Initials': 'S', 'LastName': 'Ahmad', 'Affiliation': 'Department of Radiation Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Hosang', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Radiation Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}]",Journal of applied clinical medical physics,['10.1002/acm2.12899']
2181,32418881,Pelvic Floor Muscle Training and Erectile Dysfunction in Radical Prostatectomy: A Randomized Controlled Trial Investigating a Non-Invasive Addition to Penile Rehabilitation.,"INTRODUCTION


Pelvic floor muscle (PFM) training for postprostatectomy incontinence is considered a first line approach to rehabilitation, but PFM training for erectile dysfunction (ED) after surgery is less well known. With more than 1.4 million new cases diagnosed globally per year, there is a need for non-invasive options to assist sexual dysfunction recovery.
AIM


Commencing preoperatively and using both fast and slow twitch fibre training performed in standing postures, new protocols were developed to address clinical presentations with aims to reduce ED and impact on quality of life (QoL). Comparisons with ""usual care"" PFM training, prerehabilitation and postrehabilitation were then assessed.
METHODS


A randomised controlled trial of 97 men undergoing radical prostatectomy (RP) were allocated to either a control group (n = 47) performing ""usual care"" of 3 sets/d PFMT or an intervention group (n = 50), performing 6 sets/d in standing, commencing 5 weeks before RP.
OUTCOME MEASURES


Participants were assessed preoperatively and at 2, 6, and 12 weeks after RP using the Expanded Prostate Cancer Index Composite for Clinical Practice, International Index of Erectile Function-5, and real time ultrasound measurements of PFM function.
RESULTS


At all time points, there was a significant difference (P< 0.05) between groups; however, the only time point where this difference was clinically relevant was at 2 weeks after RP, with the intervention group reporting less distress in the Expanded Prostate Cancer Index Composite for Clinical Practice QoL outcome. Secondary measures of EPIC-EF and real time ultrasound PFM function tests demonstrated improvement over all time points in both groups with lower bothersome scores in the intervention group.
CONCLUSIONS


Early PFM training reduces early QoL impact for postprostatectomy ED, with faster return to continence enabling earlier commencement of penile rehabilitation. While our 12-week protocol and sample size was not powerful enough to demonstrate conclusive benefits of early PFM training for ED, PFM intervention after RP over longer times has been supported by others. Milios JE, Ackland TR, Green DJ. Pelvic Floor Muscle Training and Erectile Dysfunction in Radical Prostatectomy: A Randomized Controlled Trial Investigating a Non-Invasive Addition to Penile Rehabilitation. J Sex Med 2020;XX:XXX-XXX.",2020,"Secondary measures of EPIC-EF and real time ultrasound PFM function tests demonstrated improvement over all time points in both groups with lower bothersome scores in the intervention group.
","['97 men undergoing', 'Radical Prostatectomy']","['Pelvic floor muscle (PFM) training', 'PFM training', 'radical prostatectomy (RP', 'Pelvic Floor Muscle Training', 'Penile Rehabilitation', 'control group (n\xa0= 47) performing ""usual care"" of 3 sets/d PFMT or an intervention group']","['EPIC-EF and real time ultrasound PFM function tests', 'bothersome scores', 'quality of life (QoL']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",97.0,0.077007,"Secondary measures of EPIC-EF and real time ultrasound PFM function tests demonstrated improvement over all time points in both groups with lower bothersome scores in the intervention group.
","[{'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Milios', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia. Electronic address: jomilios22@gmail.com.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Ackland', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia.'}]",Sexual medicine,['10.1016/j.esxm.2020.03.005']
2182,32419128,Resuscitation of the patient with suspected/confirmed COVID-19 when wearing personal protective equipment: A randomized multicenter crossover simulation trial.,"BACKGROUND


The aim of the study was to evaluate various methods of chest compressions in patients with suspected/confirmed SARS-CoV-2 infection conducted by medical students wearing full personal protective equipment (PPE) for aerosol generating procedures (AGP).
METHODS


This was prospective, randomized, multicenter, single-blinded, crossover simulation trial. Thirty-five medical students after an advanced cardiovascular life support course, which included performing 2-min continuous chest compression scenarios using 3 methods: (A) manual chest compression (CC), (B) compression with CPRMeter, (C) compression with LifeLine ARM device. During resuscitation they are wearing full personal protective equipment for aerosol generating procedures.
RESULTS


The median chest compression depth using manual CC, CPRMeter and LifeLine ARM varied and amounted to 40 (38-45) vs. 45 (40-50) vs. 51 (50-52) mm, respectively (p = 0.002). The median chest compression rate was 109 (IQR; 102-131) compressions per minute (CPM) for manual CC, 107 (105-127) CPM for CPRMeter, and 102 (101-102) CPM for LifeLine ARM (p = 0.027). The percentage of correct chest recoil was the highest for LifeLine ARM - 100% (95-100), 80% (60-90) in CPRMeter group, and the lowest for manual CC - 29% (26-48).
CONCLUSIONS


According to the results of this simulation trial, automated chest compression devices (ACCD) should be used for chest compression of patients with suspected/confirmed COVID-19. In the absence of ACCD, it seems reasonable to change the cardiopulmonary resuscitation algorithm (in the context of patients with suspected/confirmed COVID-19) by reducing the duration of the CPR cycle from the current 2-min to 1-min cycles due to a statistically significant reduction in the quality of chest compressions among rescuers wearing PPE AGP.",2020,"The percentage of correct chest recoil was the highest for LifeLine ARM - 100% (95-100), 80% (60-90) in CPRMeter group, and the lowest for manual CC - 29% (26-48).
","['patients with suspected/confirmed SARS-CoV-2 infection conducted by medical students wearing full personal protective equipment (PPE) for aerosol generating procedures (AGP', 'Thirty-five medical students after an advanced cardiovascular life support course, which included performing']","['automated chest compression devices (ACCD', '2-min continuous chest compression scenarios using 3 methods: (A) manual chest compression (CC), (B) compression with CPRMeter, (C) compression with LifeLine ARM device']","['percentage of correct chest recoil', 'median chest compression depth', 'median chest compression rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",35.0,0.0730583,"The percentage of correct chest recoil was the highest for LifeLine ARM - 100% (95-100), 80% (60-90) in CPRMeter group, and the lowest for manual CC - 29% (26-48).
","[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Malysz', 'Affiliation': 'Polish Society of Disaster Medicine, Warsaw, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Dabrowski', 'Affiliation': 'Chair and Department of Medical Education, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Bernd W', 'Initials': 'BW', 'LastName': 'Böttiger', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Cologne, Köln, Germany.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Smereka', 'Affiliation': 'Department of Emergency Medical Service, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Klaudia', 'Initials': 'K', 'LastName': 'Kulak', 'Affiliation': 'Lazarski University, Warsaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Szarpak', 'Affiliation': 'Maria Skłodowska-Curie Warsaw University, Warsaw, Poland.'}, {'ForeName': 'Milosz', 'Initials': 'M', 'LastName': 'Jaguszewski', 'Affiliation': 'First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Krzysztof J', 'Initials': 'KJ', 'LastName': 'Filipiak', 'Affiliation': 'First Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Jerzy R', 'Initials': 'JR', 'LastName': 'Ladny', 'Affiliation': 'Clinic of Emergency Medicine, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Ruetzler', 'Affiliation': 'Departments of General Anesthesiology and Outcomes Research, Cleveland Clinic, Anesthesiology Institute, Cleveland, OH, USA.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Szarpak', 'Affiliation': 'Lazarski University, Warsaw, Poland. lukasz.szarpak@gmail.com.'}]",Cardiology journal,['10.5603/CJ.a2020.0068']
2183,32419143,"Comment on ""Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single-center phase II clinical trial for safety and efficacy"".",,2020,,['gastric cancer'],[],[],"[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]",[],[],,0.0111715,,"[{'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Tongde Hospital of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Xiyin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Traditional Chinese Medicine, Community Health Service Center of Guali Town of Xiaoshan, Hangzhou, China.'}]",Journal of surgical oncology,['10.1002/jso.25954']
2184,32419304,"Efficacy and Safety of PF-06651600 (Ritlecitinib), a Novel JAK3/TEC Inhibitor in Patients with Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate.","OBJECTIVE


This Phase 2a, 8-week, double-blind, parallel-group study evaluated the efficacy and safety of PF-06651600 (ritlecitinib), an irreversible inhibitor of Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family, versus placebo, in patients with rheumatoid arthritis (RA).
METHODS


Seventy patients, seropositive for anticitrullinated protein antibodies and/or rheumatoid factor, were randomized 3:2 to receive oral PF-06651600 (200 mg once daily [QD]) or placebo for 8 weeks. Patients had an inadequate response to methotrexate and up to 50% could have previously received 1 tumor necrosis factor inhibitor. The primary endpoint was change from baseline in Simple Disease Activity Index (SDAI) score at Week 8, assessed via Bayesian analysis using an informative prior distribution for placebo response.
RESULTS


Mean change from baseline SDAI score at Week 8, was greater in the PF-06651600 group (-26.1 [95% credible interval -29.7, -22.4]) versus placebo (-16.8 [-20.9, -12.7]; P < 0.001). Most adverse events (AEs) were mild in severity, and no treatment-related serious or severe AEs, or deaths were reported. The most common classes of AEs were infections and infestations and skin and subcutaneous tissue disorders; there was one mild case of herpes simplex in the PF-06651600 group that was considered to be treatment-related, which resolved within 3 days without study treatment discontinuation or antiviral therapy.
CONCLUSION


Treatment with the oral JAK3/TEC inhibitor, PF-06651600 (200 mg QD) was associated with statistically significant improvements in RA disease activity and was generally well-tolerated in this small 8-week study.",2020,"Most adverse events (AEs) were mild in severity, and no treatment-related serious or severe AEs, or deaths were reported.","['patients with rheumatoid arthritis (RA', 'Seventy patients, seropositive for anticitrullinated protein antibodies and/or rheumatoid factor', 'Patients with Moderate to Severe Rheumatoid Arthritis']","['oral PF-06651600 (200\xa0mg once daily [QD]) or placebo', 'oral JAK3/TEC inhibitor, PF-06651600', 'methotrexate', 'PF-06651600 (Ritlecitinib), a Novel JAK3/TEC Inhibitor', 'PF-06651600 (ritlecitinib', 'Methotrexate', 'placebo']","['infections and infestations and skin and subcutaneous tissue disorders', 'Mean change from baseline SDAI score', 'Simple Disease Activity Index (SDAI) score', 'RA disease activity', 'serious or severe AEs, or deaths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C1445860', 'cui_str': 'Protein antibody'}, {'cui': 'C0035448', 'cui_str': 'Rheumatoid factor'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4505882', 'cui_str': 'PF-06651600'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0178298', 'cui_str': 'Disorder of skin and/or subcutaneous tissue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.272349,"Most adverse events (AEs) were mild in severity, and no treatment-related serious or severe AEs, or deaths were reported.","[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Robinson', 'Affiliation': 'California Medical Research Associates, Northridge, CA, USA.'}, {'ForeName': 'Nemanja', 'Initials': 'N', 'LastName': 'Damjanov', 'Affiliation': 'Institute of Rheumatology, Belgrade University School of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Bojana', 'Initials': 'B', 'LastName': 'Stamenkovic', 'Affiliation': 'Rheumatology Clinic, Institute for Treatment and Rehabilitation Niska Banja, Nis University School of Medicine, Nis, Serbia.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Radunovic', 'Affiliation': 'Institute of Rheumatology, Belgrade University School of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, PA, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Cox', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Zorayr', 'Initials': 'Z', 'LastName': 'Manukyan', 'Affiliation': 'Early Clinical Development Unit, Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Banfield', 'Affiliation': 'Early Clinical Development Unit, Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Saunders', 'Affiliation': 'Early Clinical Development Unit, Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Chandra', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Vincent', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mancuso', 'Affiliation': 'Early Clinical Development Unit, Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Peeva', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Beebe', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, NY, USA.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41316']
2185,32419310,Effect of high bicarbonate hemodialysis solution on biochemical parameters and anthropometric indices.,"INTRODUCTION


Protein energy wasting is an adverse consequence of renal failure, which is correlated with increased mortality and morbidity. Metabolic acidosis has a major role in the development of protein energy wasting in hemodialysis patients. Every effort that could ameliorate this catabolic state would be beneficial to stabilize body composition. The aim of this study was to investigate the possible beneficial effects of high bicarbonate dialysis on anthropometric indices and biochemical parameters of nutrition.
METHODS


Fifty-six hemodialysis patients were randomly enrolled in two groups: an intervention group that underwent hemodialysis for 6 months with high bicarbonate dialysate concentration (36 mmol/L, N = 26) and a control group that underwent hemodialysis using a bicarbonate dialysate concentration of 30 mmol/L (N = 30). Biochemical parameters of nutrition and weight, body mass index (BMI), total body water, percent body fat, and other anthropometric indices were measured at the beginning and the end of the trial.
FINDINGS


At the end of the 6 month evaluation period, plasma levels of albumin, phosphorus, K, calcium, and bicarbonate showed no significant changes. Body weight and BMI increased significantly in high bicarbonate arm but did not change significantly in the control group. Percent body fat in the arms and legs did not change in intervention arm, but decreased significantly in the controls.
DISCUSSION


The results suggest that higher bicarbonate dialysis can have beneficial effects on nutritional status and might protect against loss of fat mass.",2020,"Percent body fat in the arms and legs did not change in intervention arm, but decreased significantly in the controls.
","['Fifty-six hemodialysis patients', 'hemodialysis patients']","['bicarbonate hemodialysis solution', 'control group that underwent hemodialysis using a bicarbonate dialysate concentration of 30\u2009mmol/L', 'bicarbonate dialysis', 'intervention group that underwent hemodialysis for 6\u2009months with high bicarbonate dialysate concentration']","['plasma levels of albumin, phosphorus, K, calcium, and bicarbonate', 'Body weight and BMI', 'mortality and morbidity', 'Biochemical parameters of nutrition and weight, body mass index (BMI), total body water, percent body fat, and other anthropometric indices', 'biochemical parameters and anthropometric indices']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0019006', 'cui_str': 'Hemodialysis solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",56.0,0.0196057,"Percent body fat in the arms and legs did not change in intervention arm, but decreased significantly in the controls.
","[{'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Hefzollah', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Bushehr University of Medical Sciences, Bushehr, Iran.'}, {'ForeName': 'Saeid Najafpour', 'Initials': 'SN', 'LastName': 'Boushehri', 'Affiliation': 'Department of Nutrition, School of Health and Nutrition, Bushehr University of Medical Sciences, Bushehr, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Mahmudpour', 'Affiliation': 'The Persian Gulf Tropical Medicine Research Center, The Persian Gulf Biomedical Sciences Research Institute, Bushehr University of Medical Sciences, Bushehr, Iran.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12842']
2186,32418809,Effect of transspinal direct current stimulation on afferent pain signalling in humans.,"Anodal transspinal Direct Current Stimulation (tsDCS) has been suggested as a means to treat neuropathic pain by reducing pain signalling/processing and Laser Evoked Potentials (LEPs) likewise as a method to evaluate such reduction. However, results in previous studies are disagreeing. To evaluate these claims using rigorous methodology, LEPs were evoked from hands and feet in healthy volunteers. The N2 potential and three psychophysic parameters (general- and pinprick pain, warmth) were used to evaluate the signalling and appreciation of pain respectively. This was made at three time points; at baseline, directly- and 30 min after low thoracic tsDCS (20 min, 2.5 mA, cathode on shoulder). The study was randomized, cross over, double blinded and placebo controlled. At the group level, low thoracic anodal tsDCS produced reduced perceptions of all three tested pain qualities from the foot (p < 0.05 - p < 0.001). These reductions began during stimulation and became more pronounced during the 30 min after its cessation (p < 0.05 - p < 0.01). The LEP parameter alteration mirroring these changes was latency prolongation (p < 0.05 - p < 0.001) whereas amplitude reductions were in par with placebo stimulation. Similar but less pronounced and only transient (during stimulation, p < 0.05 - p < 0.001) changes, were seen for hand stimulation. The interindividual variation was large. The findings indicate that anodal tsDCS may become a technique to treat neuropathic pain by reducing pain signalling/processing and LEPs likewise a method to evaluate such reduction.",2020,"At the group level, low thoracic anodal tsDCS produced reduced perceptions of all three tested pain qualities from the foot (","['healthy volunteers', 'humans']","['placebo', 'anodal tsDCS', 'Anodal transspinal Direct Current Stimulation (tsDCS', 'transspinal direct current stimulation']","['pain qualities', 'latency prolongation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",,0.0976847,"At the group level, low thoracic anodal tsDCS produced reduced perceptions of all three tested pain qualities from the foot (","[{'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Thordstein', 'Affiliation': 'Department of Clinical Neurophysiology and Department of Biomedical and Clinical Science, Linköping University, Linköping, Sweden. Electronic address: magnus.thordstein@liu.se.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Svantesson', 'Affiliation': 'Department of Clinical Neurophysiology and Department of Biomedical and Clinical Science, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Hedayat', 'Initials': 'H', 'LastName': 'Rahin', 'Affiliation': 'Department of Clinical Neurophysiology and Department of Biomedical and Clinical Science, Linköping University, Linköping, Sweden.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.04.116']
2187,32418846,Orally Administered Alpha Lipoic Acid as a Treatment for Geographic Atrophy: A Randomized Clinical Trial.,"PURPOSE


Alpha lipoic acid (ALA) is a nutraceutical and potent antioxidant that has shown efficacy in the retina light damage mouse model and in humans for multiple sclerosis. Our objective was to evaluate the efficacy and safety of oral ALA for the treatment of geographic atrophy (GA).
DESIGN


Randomized, controlled, double-masked, multicenter phase 2 clinical trial of ALA versus placebo.
PARTICIPANTS


Participants with unilateral or bilateral GA from age-related macular degeneration.
METHODS


Participants were randomized to 1200 mg daily of ALA or placebo. Fundus autofluorescence, fundus color photography, and spectral-domain OCT were conducted and best-corrected visual acuity (BCVA) was obtained at baseline and every 6 months through month 18.
MAIN OUTCOME MEASURES


Annual rate of change over 18 months in square root-transformed area of GA in study eyes as measured on fundus autofluorescence. Secondary outcomes included the number of adverse events (AEs), change in BCVA, and annual rate of change in area of GA measured on color photographs.
RESULTS


Fifty-three participants (mean age, 80 years) were randomized (April 2016-August 2017). Twenty-seven participants (37 eyes) were in the placebo group, and 26 participants (36 eyes) were in the ALA group. Unadjusted mean (standard error) annual change in GA area was 0.28 (0.02) mm and 0.31 mm (0.02 mm) for the placebo and ALA groups, respectively (difference, 0.04 mm; 95% confidence interval [CI], -0.03 to 0.11 mm; P = 0.30). Adjusting for baseline GA area, number of GA lesions, and presence of subfoveal GA, the mean annual change in GA area was 0.27 (0.04) mm and 0.32 (0.05) mm for the placebo and ALA groups, respectively (difference, 0.05 mm; 95% CI, -0.02 to 0.12 mm; P = 0.14). At 18 months, the percent of eyes losing 15 letters or more of BCVA was 22% (8 of 36) and 14% (5 of 36) in the placebo and ALA groups, respectively (P = 0.54). No difference was found in the percentage of participants with nonserious AEs (P = 0.96) or serious AEs (P = 0.28) between the placebo and ALA groups.
CONCLUSIONS


Results do not support ALA having beneficial effects on GA or BCVA. This trial design may be useful for other GA repurposing drug trials.",2020,"No difference was found in the percentage of participants with nonserious AEs (P = 0.96) or serious AEs (P = 0.28) between the placebo and ALA groups.
","['Participants with unilateral or bilateral GA from age-related macular degeneration', 'Twenty-seven participants (37 eyes) were in the placebo group, and 26 participants (36 eyes) were in the ALA group', 'Fifty-three participants (mean age, 80 years', 'Participants', 'Geographic Atrophy']","['Alpha lipoic acid (ALA', 'ALA or placebo', 'oral ALA', 'Alpha Lipoic Acid', 'ALA versus placebo', 'placebo']","['number of adverse events (AEs), change in BCVA, and annual rate of change in area of GA measured on color photographs', 'Fundus autofluorescence, fundus color photography, and spectral-domain OCT were conducted and best-corrected visual acuity (BCVA', 'percent of eyes losing 15 letters or more of BCVA', 'efficacy and safety', 'Unadjusted mean (standard error) annual change in GA area', 'baseline GA area, number of GA lesions, and presence of subfoveal GA, the mean annual change in GA area']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C4324299', 'cui_str': 'Fundus autofluorescence'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}]",,0.764548,"No difference was found in the percentage of participants with nonserious AEs (P = 0.96) or serious AEs (P = 0.28) between the placebo and ALA groups.
","[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: Benjamin.Kim@uphs.upenn.edu.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hunter', 'Affiliation': 'Oregon Eye Consultants, Eugene, Oregon.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Brucker', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hahn', 'Affiliation': 'New Jersey Retina, Teaneck, New Jersey.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gehrs', 'Affiliation': 'Department of Ophthalmology, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Apurva', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Retina Northwest, Portland, Oregon.'}, {'ForeName': 'Albert O', 'Initials': 'AO', 'LastName': 'Edwards', 'Affiliation': 'Oregon Retina, Eugene, Oregon.'}, {'ForeName': 'Yafeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California.'}, {'ForeName': 'Itzhak', 'Initials': 'I', 'LastName': 'Nissim', 'Affiliation': ""Division of Genetics and Metabolic Disease, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Department of Pediatrics, Biochemistry and Biophysics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Ebenezer', 'Initials': 'E', 'LastName': 'Daniel', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Grunwald', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Gui-Shuang', 'Initials': 'GS', 'LastName': 'Ying', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Pistilli', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Dunaief', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.03.019']
2188,32419092,Image quality and radiation dose of different scanning protocols in DSCT cardiothoracic angiography for children with tetralogy of fallot.,"The aim of this study was to investigate the image quality and radiation dose of different scanning protocols in dual-source CT cardiothoracic angiography for children with tetralogy of Fallot (TOF). Seventy-five consecutive children with known or suspected TOF were enrolled to undergo prospective ECG-triggering sequential dual-source CT (DSCT) cardiothoracic angiography. According to the scanning protocols, these patients were randomly divided into 3 groups: fixed delay time (FDT, n = 25, group A), automatic bolus-tracking (ABT, n = 25, group B) and manual bolus-tracking (MBT, n = 25, group C). Subjective and objective image quality were evaluated. The radiation doses were recorded. The image quality scores of group C were significantly higher than those of group A and B. The absolute value of difference (D-value) on CT attenuation between left (CT LV ) and right ventricle (CT RV ) in group C was significantly lower than that in group A and B. The total effective dose of groups A, B and C were 0.39 ± 0.06 mSv, 0.40 ± 0.07 mSv and 0.40 ± 0.08 mSv, respectively. There was no significant difference among 3 groups (P = 0.722). Scanning protocol has significantly impacts on the image quality of cardiovascular structures for TOF patients. Compared with the conventional scanning protocols FDT and ABT, the MBT technique provides high image quality and achieves more homogenous attenuation among different patients with TOF.",2020,The image quality scores of group C were significantly higher than those of group A and B.,"['children with tetralogy of fallot', 'children with tetralogy of Fallot (TOF', 'TOF patients', 'Seventy-five consecutive children with known or suspected TOF were enrolled to undergo prospective']","['DSCT cardiothoracic angiography', 'scanning protocols in dual-source CT cardiothoracic angiography', 'ECG-triggering sequential dual-source CT (DSCT) cardiothoracic angiography', 'fixed delay time (FDT, n\u2009=\u200925, group A), automatic bolus-tracking (ABT, n\u2009=\u200925, group B) and manual bolus-tracking (MBT']","['Subjective and objective image quality', 'CT attenuation between left (CT LV ) and right ventricle (CT RV ', 'image quality scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0045246', 'cui_str': ""2,2'-azino-di-(3-ethylbenzothiazoline)-6-sulfonic acid""}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0054631', 'cui_str': '2-MERCAPTOBENZOTHIAZOLE'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0225883', 'cui_str': 'Right cardiac ventricular structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",75.0,0.0167736,The image quality scores of group C were significantly higher than those of group A and B.,"[{'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Duan', 'Affiliation': ""Department of Medical Imaging, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, 210002, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Ultrasound, Shandong Provincial Hospital Affliated to Shandong First Medical University, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Radiology, Shandong Medical Imaging Research Institute, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Baoting', 'Initials': 'B', 'LastName': 'Chao', 'Affiliation': ""Department of Radiology, Shandong Medical Imaging Research Institute, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Zhaoping', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': ""Department of Radiology, Shandong Medical Imaging Research Institute, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': ""Department of Radiology, Shandong Medical Imaging Research Institute, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Department of Radiology, Shandong Provincial Hospital Affliated to Shandong First Medical University, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Baojin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Department of Radiology, Shandong Provincial Hospital Affliated to Shandong First Medical University, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ""CT Scientific Collaboration, Siemens Healthcare Limited, Beijing, 100102, People's Republic of China.""}, {'ForeName': 'Ximing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Shandong Provincial Hospital Affliated to Shandong First Medical University, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China. wxming369@163.com.""}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Lu', 'Affiliation': ""Department of Medical Imaging, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, 210002, People's Republic of China. gmlu369@163.com.""}]",The international journal of cardiovascular imaging,['10.1007/s10554-020-01882-w']
2189,32419303,"Influence of Clinical, Physical, Psychological and Psychophysical Variables on Treatment Outcomes in Somatic Tinnitus associated to Temporomandibular Pain: Evidence from a Randomized Clinical Trial.","OBJECTIVE


To assess the influence of clinical, psychological, and psychophysical variables on treatment outcomes after application of exercise combined with education with/without manual therapy in people with tinnitus associated to TMD.
METHODS


A secondary analysis of a clinical trial investigating the effectiveness of including cervico-mandibular manual therapy into an exercise combined with education program in 61 subjects with TMD-related tinnitus was performed. Clinical outcomes including tinnitus severity and related-handicap were assessed at 3 and 6 months post-intervention. Patients completed at baseline clinical (severity, handicap, quality of life), physical (range of motion), psychological (depression), and psychophysical (pressure pain thresholds, PPTs) variables which were included as predictors.
RESULTS


The regression models indicated that higher scores of tinnitus severity at baseline predicted better outcomes 3 and 6 months post-intervention (explaining from 13% to 41% of the variance) in both groups. Higher scores of related-handicap at baseline predicted better outcome of tinnitus handicap (45% variance) in the manual therapy with exercise/education group. Lower PPTs over the temporalis muscle at baseline predicted poorer clinical outcomes (from 10.5% to 41% of the variance) in both groups. Other predictors were sex and quality of life (6.7% variance) in the manual therapy group and PPTs over the masseter muscle (5.8% variance) in the exercise/education group.
CONCLUSION


This study found that baseline tinnitus severity and localized PPT over the temporalis muscle were predictive of clinical outcomes in individuals with TMD-related tinnitus following physical therapy. Other predictors, e.g., sex, quality of life, were less influent.",2020,Higher scores of related-handicap at baseline predicted better outcome of tinnitus handicap (45% variance) in the manual therapy with exercise/education group.,"['Somatic Tinnitus associated to Temporomandibular Pain', '61 subjects with TMD-related tinnitus was performed', 'individuals with TMD-related tinnitus following physical therapy', 'people with tinnitus associated to TMD']","['cervico-mandibular manual therapy into an exercise combined with education program', 'exercise combined with education with/without manual therapy']","['sex and quality of life', 'clinical outcomes', 'tinnitus severity and related-handicap', 'Higher scores of related-handicap', 'baseline clinical (severity, handicap, quality of life), physical (range of motion), psychological (depression), and psychophysical (pressure pain thresholds, PPTs) variables', 'sex, quality of life', 'tinnitus severity', 'tinnitus handicap']","[{'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",61.0,0.115174,Higher scores of related-handicap at baseline predicted better outcome of tinnitus handicap (45% variance) in the manual therapy with exercise/education group.,"[{'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Plaza-Manzano', 'Affiliation': 'Department of Radiology, Rehabilitation and Physiotherapy, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Delgado-de-la-Serna', 'Affiliation': 'Department of Physical Therapy, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Díaz-Arribas', 'Affiliation': 'Department of Radiology, Rehabilitation and Physiotherapy, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Diana P', 'Initials': 'DP', 'LastName': 'Rodrigues-de-Souza', 'Affiliation': 'Department of Physical Therapy, Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alburquerque-Sendín', 'Affiliation': 'Department of Physical Therapy, Universidad de Córdoba, Córdoba, Spain.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12919']
2190,32417348,Concurrent cisplatin and Dose escalation with Intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial.,"BACKGROUND


Concurrent chemoradiotherapy (CRT) is the standard of care (SoC) in locally advanced (LA) head and neck squamous cell carcinomas (HNSCC). This trial was designed to test whether dose-escalated IMRT and cisplatin could improve locoregional control without increasing complications over 3D-radiotherapy.
METHODS


patients were randomized between 70Gy/35F in 7 weeks with 3D-RT (Arm A) versus 75Gy/35F with IMRT (Arm B). Both arms received 50Gy in 25 fractions followed by a sequential boost of 20Gy/10F in Arm A and 25Gy/10F to gross tumor volume in Arm B, as well as 3 cycles of cisplatin at 100 mg/m2 during RT. The primary endpoint was locoregional progression (LRP).
RESULTS


188 patients were randomized: 85% oropharynx and 73% stage IVa. P16 status was documented for 137 oropharyngeal tumors with P16+ in 53 (39%) patients; and 90% were smokers. Median follow-up was 60.5 months. Xerostomia was markedly decreased in arm B (p<0.0001). The 1-year grade ≥ 2 xerostomia (RTOG criteria) was 63% vs 23% and 3-year 45% vs 11% in arms A and B, respectively. Xerostomia LENT-SOMA scale was also reduced in arm B. Dose-escalated IMRT did not reduce LRP with an adjusted HR of 1.13 [95%CI = 0.64-1.98] (p=0.68). Survival was not different (adjusted HR: 1.19 [95%CI = 0.78-1.81], p = 0.42). No interaction between p16 and treatment effect was found.
CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT. This trial reinforces the evidence showing IMRT reduces xerostomia in LA-HNSCC treated with radiotherapy. CLINICALTRIAL.GOV: NCT00158678.",2020,"CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","['locally advanced (LA) head and neck squamous cell carcinomas (HNSCC', '188 patients were randomized: 85% oropharynx and 73% stage IVa', 'patients', 'locally advanced head and neck squamous cell carcinomas (HNSCC']","['Concurrent chemoradiotherapy (CRT', 'radiotherapy', 'Concurrent cisplatin and Dose escalation with Intensity-modulated radiotherapy (IMRT', 'cisplatin', 'conventional radiotherapy', 'IMRT and cisplatin', '75Gy/35F with IMRT']","['1-year grade ≥ 2 xerostomia (RTOG criteria', 'Xerostomia LENT-SOMA scale', 'Survival', 'P16 status', 'Xerostomia', 'locoregional progression (LRP', 'xerostomia']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0441773', 'cui_str': 'Stage IVa'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0702216', 'cui_str': 'Soma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",188.0,0.356655,"CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","[{'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Auperin', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif; INSERM 1018, Villefjuif.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blanchard', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Institut Sainte Catherine, Avignon.'}, {'ForeName': 'Xu-Shan', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Hopital Nord Franche-Comté de Montbéliard & CHRU de Besançon.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rives', 'Affiliation': 'Institut Claudius Regaud, Toulouse.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': 'Centre Jean Bernard, Le Mans.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Castelli', 'Affiliation': 'Centre Eugène Marquis, Rennes.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Graff', 'Affiliation': 'Institut Claudius Regaud, Toulouse; Centre Alexis Vautrin, Nancy.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Wong Hee Kam', 'Affiliation': 'AP-HM Hôpital de la Timone, Marseille.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Centre Antoine Lacassagne, Nice; Centre francois Baclesse, Caen.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Veresezan', 'Affiliation': 'Centre Henri Becquerel, Rouen.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Heymann', 'Affiliation': 'Clinique Sainte Anne, Strasbourg.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Renard-Oldrini', 'Affiliation': 'Centre Alexis Vautrin, Nancy.'}, {'ForeName': 'Cédrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Centre Jean Bernard, Le Mans.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Cornely', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Casiraghi', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boisselier', 'Affiliation': 'Centre Eugène Marquis, Rennes; Institut du Cancer de Montpellier.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lapeyre', 'Affiliation': 'Centre Alexis Vautrin, Nancy; Centre Jean Perrin, Clermont-Ferrand (all in France).'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Biau', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand (all in France).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif; CHUV Lausanne, Switzerland.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.021']
2191,32100679,"Improving Complementary Food Hygiene Behaviors Using the Risk, Attitude, Norms, Ability, and Self-Regulation Approach in Rural Malawi.","The study evaluated the effectiveness of an intervention to improve complementary food hygiene behaviors among child caregivers in rural Malawi. Formative research and intervention development was grounded in the risk, attitude, norms, ability, and self-regulation (RANAS) model and targeted washing hands and kitchen utensils with soap, safe utensil storage, reheating of leftover food, and feeding of children by caregivers. Longitudinal research was applied at baseline and follow-up surveys among 320 caregivers. Determinants of selected behaviors were found, and interventions were developed based on the behavior change techniques aligned with these determinants in the RANAS model. The intervention was delivered over 9 months through group (cluster) meetings and household visits and included demonstrations, games, rewards, and songs. We randomly assigned villages to the control or intervention group. Follow-up results indicated a significant increase in three targeted behaviors (washing kitchen utensils with soap, safe utensil storage, and handwashing with soap) among intervention recipients. Several psychosocial factors differed significantly between the intervention and control groups. Mediation results showed that the intervention had a significant effect on these three targeted behaviors. For handwashing, feelings, others' behavior in the household, and remembering; for washing kitchen utensils, others' behavior in the household and difficulty to get enough soap; for safe utensils storage, others' behavior in the village and remembering mediated the effect of the intervention on the targeted behaviors. The study demonstrated that targeting food hygiene behaviors with a theory-driven behavior change approach using psychosocial factors can improve the behavior of child caregivers in rural Malawi.",2020,Several psychosocial factors differed significantly between the intervention and control groups.,"['Rural Malawi', 'child caregivers in rural Malawi', '320 caregivers']",[],['Several psychosocial factors'],"[{'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}]",[],"[{'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",,0.0199568,Several psychosocial factors differed significantly between the intervention and control groups.,"[{'ForeName': 'Kondwani', 'Initials': 'K', 'LastName': 'Chidziwisano', 'Affiliation': 'Department of Civil and Environmental Engineering, University of Strathclyde, Glasgow, United Kingdom.'}, {'ForeName': 'Jurgita', 'Initials': 'J', 'LastName': 'Slekiene', 'Affiliation': 'Eawag, Swiss Federal Institute of Aquatic Science and Technology, Dübendorf, Switzerland.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Mosler', 'Affiliation': 'Eawag, Swiss Federal Institute of Aquatic Science and Technology, Dübendorf, Switzerland.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Morse', 'Affiliation': 'Department of Civil and Environmental Engineering, University of Strathclyde, Glasgow, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0528']
2192,32420786,Effect of Curcumin on Serum Urate in Asymptomatic Hyperuricemia: A Randomized Placebo-Controlled Trial.,"Background/objective:  Hyperuricemia leads to gout and renal complications and may increase cardiovascular risk. Curcumin inhibits xanthine oxidase and increases uricosuric activity and, as a result, decreases serum urate (SU). This randomized controlled trial aimed to determine the effects of curcumin versus placebo on SU in subjects with asymptomatic hyperuricemia (SU level ≥ 6 mg/dL in women or ≥ 7 mg/dL in men). Methods:  Thirty-nine subjects with persistent hyperuricemia were randomized to receive curcumin (500-mg capsules twice daily, 20 subjects) or placebo (19 subjects). Primary outcome was the difference between SU before and 8 weeks after randomization. Secondary outcomes were differences between urine uric acid (UUA) clearance, fasting plasma glucose (FPG), and lipid profiles before and 8 weeks after randomization and adverse events. Results:  Out of 39 subjects, there were no differences at baseline SU, UUA clearance, FPG, lipid profiles, and demographics between curcumin and placebo groups. After 8 weeks, SU was significantly decreased in both groups (6.9% in curcumin group,  p  = 0.002, and 5.0% in placebo group,  p  = 0.009). However, there was no difference in SU reduction between the two groups ( p  = 0.532). There were no differences in UUA, FPG, lipid profiles, or adverse events in either group at 8 weeks after randomization. The most common adverse event was diarrhea with no treatment required. Conclusion:  Curcumin was not superior to placebo in reducing serum urate and in increasing UUA clearance.",2020,"There were no differences in UUA, FPG, lipid profiles, or adverse events in either group at 8 weeks after randomization.","['Asymptomatic Hyperuricemia', '39 subjects', 'Thirty-nine subjects with persistent hyperuricemia', 'subjects with asymptomatic hyperuricemia (SU level ≥ 6\u2009mg/dL in women or ≥ 7\u2009mg/dL in men']","['curcumin', 'Placebo', 'Curcumin', 'curcumin versus placebo', 'placebo']","['cardiovascular risk', 'SU reduction', 'UUA, FPG, lipid profiles, or adverse events', 'serum urate', 'Serum Urate', 'serum urate (SU', 'UUA clearance', 'uricosuric activity', 'urine uric acid (UUA) clearance, fasting plasma glucose (FPG), and lipid profiles before and 8\u2009weeks after randomization and adverse events', 'baseline SU, UUA clearance, FPG, lipid profiles, and demographics', 'SU']","[{'cui': 'C0348944', 'cui_str': 'Hyperuricemia without signs of inflammatory arthritis and tophaceous disease'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0428286', 'cui_str': 'Urine urate measurement'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",39.0,0.429972,"There were no differences in UUA, FPG, lipid profiles, or adverse events in either group at 8 weeks after randomization.","[{'ForeName': 'Pannipa', 'Initials': 'P', 'LastName': 'Bupparenoo', 'Affiliation': 'Rheumatic Disease Unit, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Rattapol', 'Initials': 'R', 'LastName': 'Pakchotanon', 'Affiliation': 'Rheumatic Disease Unit, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Pongthorn', 'Initials': 'P', 'LastName': 'Narongroeknawin', 'Affiliation': 'Rheumatic Disease Unit, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Paijit', 'Initials': 'P', 'LastName': 'Asavatanabodee', 'Affiliation': 'Rheumatic Disease Unit, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Sumapa', 'Initials': 'S', 'LastName': 'Chaiamnuay', 'Affiliation': 'Rheumatic Disease Unit, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}]",Journal of dietary supplements,['10.1080/19390211.2020.1757798']
2193,32421103,A Component Analysis of the Mindfulness-Based Positive Behavior Support (MBPBS) Program for Mindful Parenting by Mothers of Children with Autism Spectrum Disorder.,"Objectives


Mindfulness-Based Positive Behavior Support (MBPBS) has been shown to be effective in reducing stress and burnout in parents and professional caregivers of children and adolescents with intellectual and developmental disabilities (IDD) and autism spectrum disorder (ASD). The aim of this study was to assess the comparative effects of the mindfulness (MB) and positive behavior support (PBS) components against the MBPBS program for mindful parenting.
Methods


The study utilized a three-arm randomized controlled trial design, with a 10-week pre-treatment control condition, 30 weeks of intervention, and 3 years of post-intervention follow-up. Mothers of children with ASD were randomly assigned to the MB, PBS, and MBPBS conditions and provided 3 days of training specific to each condition. The effects of these programs were assessed on the mothers (i.e., training attendance, meditation time, perceived psychological stress) and spillover effects were assessed on their children with ASD (i.e., aggression, disruptive behavior, compliance with mothers' requests).
Results


Mothers in the MBPBS condition reported greater reductions in perceived psychological stress, followed by those in the MB condition, and with no significant changes reported by those in the PBS condition. Reduction in the children's aggression and disruptive behavior followed a similar pattern, with most to least significant reductions being in MBPBS, MB, and PBS condition, respectively. Significant increases in compliance (i.e., responsiveness to mothers' requests) were largest in the MBPBS condition, followed by MB, and then PBS. Changes across all variables for both mothers and their children were maintained for 3 years post-intervention. After time and training type were controlled for, meditation time was a significant predictor in reducing aggressive and disruptive behaviors, and in enhancing compliance of the children with mothers' requests.
Conclusions


Positive outcomes for mothers and their children with ASD were significantly greater in the MBPBS condition, followed by the MB condition, and least in the PBS condition. MBPBS appears to be an effective mindful parenting program on the assessed variables.",2020,"After time and training type were controlled for, meditation time was a significant predictor in reducing aggressive and disruptive behaviors, and in enhancing compliance of the children with mothers' requests.
","['Mindful Parenting by Mothers of Children with Autism Spectrum Disorder', 'parents and professional caregivers of children and adolescents with intellectual and developmental disabilities (IDD) and autism spectrum disorder (ASD', 'Mothers of children with ASD', 'mindful parenting', 'mothers and their children with ASD']","['Mindfulness-Based Positive Behavior Support (MBPBS) Program', 'MBPBS', 'mindfulness (MB) and positive behavior support (PBS) components against the MBPBS program', 'Mindfulness-Based Positive Behavior Support (MBPBS']","['MBPBS, MB, and PBS condition', ""children's aggression and disruptive behavior"", 'training attendance, meditation time, perceived psychological stress) and spillover effects', 'aggressive and disruptive behaviors', 'perceived psychological stress', ""compliance (i.e., responsiveness to mothers' requests"", ""children with ASD (i.e., aggression, disruptive behavior, compliance with mothers' requests""]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]",,0.033065,"After time and training type were controlled for, meditation time was a significant predictor in reducing aggressive and disruptive behaviors, and in enhancing compliance of the children with mothers' requests.
","[{'ForeName': 'Nirbhay N', 'Initials': 'NN', 'LastName': 'Singh', 'Affiliation': '1Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA 30912 USA.'}, {'ForeName': 'Giulio E', 'Initials': 'GE', 'LastName': 'Lancioni', 'Affiliation': '2Department of Neuroscience and Sense Organs, University of Bari, Bari, Italy.'}, {'ForeName': 'Oleg N', 'Initials': 'ON', 'LastName': 'Medvedev', 'Affiliation': '3School of Psychology, University of Waikato, Hamilton, New Zealand.'}, {'ForeName': 'Yoon-Suk', 'Initials': 'YS', 'LastName': 'Hwang', 'Affiliation': '4Institute for Learning Sciences and Teacher Education, Australian Catholic University, Brisbane, Queensland Australia.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Myers', 'Affiliation': '5WellStar School of Nursing, Kennesaw State University, Kennesaw, GA USA.'}]",Mindfulness,['10.1007/s12671-020-01376-9']
2194,32421168,Effect of Patient Portal Reminders Sent by a Health Care System on Influenza Vaccination Rates: A Randomized Clinical Trial.,"Importance


Influenza vaccination rates across the US are low. Because few practices send patient reminders for influenza vaccination, a scalable patient reminder system is needed.
Objective


To evaluate the effect of patient reminders sent via a health care system's electronic health record patient portal on influenza vaccination rates.
Design, Setting, and Participants


This pragmatic, 4-arm randomized clinical trial was performed from October 1, 2018, to March 31, 2019, across the UCLA (University of California, Los Angeles) health care system. A total of 164 205 patients in 52 primary care practices who had used the patient portal within 12 months were included.
Interventions


Patients due for an influenza vaccine were sent a letter via the patient portal of the health care system reminding them about the importance of influenza vaccination, safety of the vaccine, and morbidity associated with influenza. Patients were randomized within primary care practices to 1 of 4 study groups (no reminder [n = 41 070] vs 1 reminder [n = 41 055], 2 reminders [n = 41 046], or 3 reminders [n = 41 034]).
Main Outcomes and Measures


The primary outcome was receipt of 1 or more influenza vaccines as documented in the electronic health record, which was supplemented with influenza vaccination data from external sources (eg, pharmacies). Secondary outcomes were influenza vaccination rates among subgroups and influenza vaccinations self-reported by patients in reply to the portal-based query as having been received elsewhere.
Results


A total of 164 205 patients (mean [SD] age, 46.2 [19.6] years; 95 779 [58.3%] female) were randomly allocated to 1 of the 4 study arms. In the primary analysis across all ages and not including patient self-reported vaccinations in reply to portal reminders, influenza vaccination rates were 37.5% for those receiving no reminders, 38.0% for those receiving 1 reminder (P = .008 vs no reminder), 38.2% for those receiving 2 reminders (P = .03 vs no reminder), and 38.2% for those receiving 3 reminders (P = .02 vs no reminder). In the secondary analysis not including patient self-reported vaccinations, among adults aged 18 to 64 years (vaccination rates: 32.0% in the control group, 32.8% in the 1-reminder group, 32.8% in the 2-reminder group, and 32.8% in the 3-reminder group; P = .001), male patients (vaccination rates: 37.3% vs 38.3%, 38.6%, and 38.8%; P = .001), non-Hispanic patients (vaccination rates: 37.6% vs 38.2%, 38.3%, and 38.2%; P = .004), and those who were not vaccinated in the prior 2 years (vaccination rates: 15.3% vs 15.9%, 16.3%, and 16.1%; P < .001), vaccination rates were higher in the portal reminder groups than in the control group; the findings in these 3 subgroups mirrored the findings in the entire population. When self-reported vaccinations received elsewhere were included, influenza vaccination rates were 1.4 to 2.9 percentage points higher in the portal reminder groups, with a dose-response effect (0 reminders: 15 537 [37.8%]; 1 reminder: 16 097 [39.2%]; 2 reminders: 16 426 [40.0%]; and 3 reminders: 16 714 [40.7%]; P < .001).
Conclusions and Relevance


Generic patient portal reminders were effective in minimally increasing influenza vaccination rates, but more intensive or more targeted patient motivational strategies appear to be needed.
Trial Registration


ClinicalTrials.gov Identifier: NCT03666026.",2020,"Conclusions and Relevance


Generic patient portal reminders were effective in minimally increasing influenza vaccination rates, but more intensive or more targeted patient motivational strategies appear to be needed.
","['October 1, 2018, to March 31, 2019, across the UCLA (University of California, Los Angeles) health care system', 'A total of 164\u202f205 patients (mean [SD] age, 46.2 [19.6] years; 95 779 [58.3%] female', '164 205 patients in 52 primary care practices who had used the patient portal within 12 months were included']","['no reminder [n\u2009=\u200941 070] vs 1 reminder [n\u2009=\u200941 055], 2 reminders [n\u2009=\u200941 046], or 3 reminders [n\u2009=\u200941 034']","['Influenza Vaccination Rates', 'influenza vaccination data from external sources (eg, pharmacies', 'influenza vaccination rates', 'patient self-reported vaccinations in reply to portal reminders, influenza vaccination rates', 'vaccination rates', 'receipt of 1 or more influenza vaccines', 'influenza vaccination rates among subgroups and influenza vaccinations self-reported by patients in reply to the portal-based query as having been received elsewhere']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4277550', 'cui_str': 'Patient Portal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",164205.0,0.190866,"Conclusions and Relevance


Generic patient portal reminders were effective in minimally increasing influenza vaccination rates, but more intensive or more targeted patient motivational strategies appear to be needed.
","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Szilagyi', 'Affiliation': ""Department of Pediatrics, UCLA (University of California, Los Angeles) Mattel Children's Hospital, UCLA.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Albertin', 'Affiliation': ""Department of Pediatrics, UCLA (University of California, Los Angeles) Mattel Children's Hospital, UCLA.""}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Casillas', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, UCLA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Valderrama', 'Affiliation': ""Department of Pediatrics, UCLA (University of California, Los Angeles) Mattel Children's Hospital, UCLA.""}, {'ForeName': 'O Kenrik', 'Initials': 'OK', 'LastName': 'Duru', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, UCLA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Ong', 'Affiliation': 'Department of Medicine, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Vangala', 'Affiliation': 'Department of Medicine Statistics Core, David Geffen School of Medicine, UCLA.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine Statistics Core, David Geffen School of Medicine, UCLA.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Rand', 'Affiliation': 'Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Sharon G', 'Initials': 'SG', 'LastName': 'Humiston', 'Affiliation': ""Department of Pediatrics, Children's Mercy, Kansas City, Missouri.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': 'Department of Information Services and Solutions, UCLA Health System, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sloyan', 'Affiliation': 'Department of Information Services and Solutions, UCLA Health System, Los Angeles, California.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Lerner', 'Affiliation': ""Department of Pediatrics, UCLA (University of California, Los Angeles) Mattel Children's Hospital, UCLA.""}]",JAMA internal medicine,['10.1001/jamainternmed.2020.1602']
2195,31047023,I Am the Clinical Trial.,,2019,,[],[],[],[],[],[],,0.02603,,"[{'ForeName': 'Jillianne', 'Initials': 'J', 'LastName': 'Code', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2018.12.019']
2196,32416978,"Randomized, assessor-blinded trial comparing highly purified human menotropin and recombinant follicle-stimulating hormone in high responders undergoing intracytoplasmic sperm injection.","OBJECTIVE


To evaluate the efficacy and safety of highly purified human menotropin (HP-hMG) and recombinant follicle-stimulating hormone (rFSH) for controlled ovarian stimulation in a population of patients predicted to be high responders.
DESIGN


Randomized, open-label, assessor-blinded, parallel-group, noninferiority trial.
SETTING


Fertility centers.
PATIENT(S)


A total of 620 women with serum antimüllerian hormone (AMH) ≥5 ng/mL.
INTERVENTION(S)


Controlled ovarian stimulation with HP-hMG or rFSH in a GnRH antagonist assisted reproductive technology (ART) cycle. Fresh transfer of a single blastocyst was performed unless ovarian response was excessive, in which all embryos were cryopreserved. Subjects could undergo subsequent frozen blastocyst transfer within 6 months of randomization.
MAIN OUTCOME MEASURE(S)


Ongoing pregnancy rate (OPR) after fresh transfer (primary endpoint), as well as cumulative live birth, ovarian hyperstimulation syndrome (OHSS), and pregnancy loss rates.
RESULTS


OPR/cycle start after fresh transfer was 35.5% with HP-hMG and 30.7% with rFSH (difference: 4.7%, 95% CI -2.7%, 12.1%); noninferiority was established. Compared to rFSH, HP-hMG was associated with significantly lower OHSS (21.4% vs. 9.7% respectively; difference: -11.7%, 95% CI -17.3%, -6.1%) and cumulative early pregnancy loss rates (25.5% vs. 14.5% respectively; difference: -11.0%, 95% CI -18.8%, -3.14%). Despite 43 more transfers in the rFSH group, cumulative live birth rates were similar with HP-hMG and rFSH at 50.6% and 51.5% respectively (difference: -0.8%, 95% CI -8.7%, 7.1%).
CONCLUSION(S)


In high responders, HP-hMG provided comparable efficacy to rFSH with fewer adverse events, including pregnancy loss, suggesting its optimized risk/benefit profile in this population.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02554279 (clinicaltrials.gov).",2020,"Despite 43 more transfers in the rFSH group, cumulative live birth rates were similar with HP-hMG and rFSH at 50.6% and 51.5% respectively (difference:","['high responders undergoing intracytoplasmic sperm injection', '620 women with serum antimüllerian hormone (AMH) ≥5', 'Fertility centers']","['HP-hMG or rFSH', 'highly purified human menotropin (HP-hMG) and recombinant follicle-stimulating hormone (rFSH', 'purified human menotropin and recombinant follicle-stimulating hormone', 'rFSH']","['cumulative early pregnancy loss rates', 'pregnancy loss', 'OHSS', 'Ongoing pregnancy rate (OPR', 'efficacy and safety', 'subsequent frozen blastocyst transfer', 'cumulative live birth rates', 'cumulative live birth, ovarian hyperstimulation syndrome (OHSS), and pregnancy loss rates']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0025326', 'cui_str': 'human menopausal gonadotrophin'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}]","[{'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0156543', 'cui_str': 'Pregnancy with abortive outcome'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0936221', 'cui_str': 'Blastocyst Transfer'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]",620.0,0.661804,"Despite 43 more transfers in the rFSH group, cumulative live birth rates were similar with HP-hMG and rFSH at 50.6% and 51.5% respectively (difference:","[{'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Witz', 'Affiliation': 'Houston Fertility Institute, Houston, Texas.'}, {'ForeName': 'Gaurang S', 'Initials': 'GS', 'LastName': 'Daftary', 'Affiliation': 'Ferring Pharmaceuticals, Inc., Parsippany, New Jersey.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Doody', 'Affiliation': 'Center for Assisted Reproduction, Bedford, Texas.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Carolina Conceptions, Raleigh, North Carolina.'}, {'ForeName': 'Yodit', 'Initials': 'Y', 'LastName': 'Seifu', 'Affiliation': 'Ferring Pharmaceuticals, Inc., Parsippany, New Jersey.'}, {'ForeName': 'Vladimir I', 'Initials': 'VI', 'LastName': 'Yankov', 'Affiliation': 'Ferring Pharmaceuticals, Inc., Parsippany, New Jersey.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Heiser', 'Affiliation': 'Ferring Pharmaceuticals, Inc., Parsippany, New Jersey. Electronic address: Patrick.Heiser@ferring.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2020.03.029']
2197,32417063,Commentary: Noninferiority trial: The devil is….,,2020,,[],[],[],[],[],[],,0.112838,,"[{'ForeName': 'Arnaldo', 'Initials': 'A', 'LastName': 'Dimagli', 'Affiliation': 'Bristol Heart Institute, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Benedetto', 'Affiliation': 'Bristol Heart Institute, University of Bristol, Bristol, United Kingdom. Electronic address: umberto.benedetto@bristol.ac.uk.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.04.043']
2198,32417102,"Corrigendum to ""Study protocol: CareAvenue program to improve unmet social risk factors and diabetes outcomes - A randomized controlled trial"" [Contemporary Clinical Trials 89 (2020) 105933].",,2020,,[],[],[],[],[],[],,0.05593,,"[{'ForeName': 'Minal R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America. Electronic address: minalrp@umich.edu.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America; Department of Internal Medicine, Michigan Medicine, United States of America; U.S. Department of Veterans Affairs VA, Ann Arbor Healthcare System, United States of America.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Piette', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America; U.S. Department of Veterans Affairs VA, Ann Arbor Healthcare System, United States of America.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Peter X K', 'Initials': 'PXK', 'LastName': 'Song', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Hae Mi', 'Initials': 'HM', 'LastName': 'Choe', 'Affiliation': 'College of Pharmacy, University of Michigan, United States of America; University of Michigan Medical Group, United States of America.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Tobi', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106025']
2199,32421159,Effect of Endovascular Treatment With Medical Management vs Standard Care on Severe Cerebral Venous Thrombosis: The TO-ACT Randomized Clinical Trial.,"Importance


To date, only uncontrolled studies have evaluated the efficacy and safety of endovascular treatment (EVT) in patients with cerebral venous thrombosis (CVT), leading to the lack of recommendations on EVT for CVT.
Objective


To evaluate the efficacy and safety of EVT in patients with a severe form of CVT.
Design, Setting, and Participants


TO-ACT (Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis) was a multicenter, open-label, blinded end point, randomized clinical trial conducted in 8 hospitals in 3 countries (the Netherlands, China, and Portugal). Patients were recruited from September 2011 to October 2016, and follow-up began in March 2012 and was completed in December 2017. Adult patients with radiologically confirmed CVT who had at least 1 risk factor for a poor outcome (mental status disorder, coma state, intracerebral hemorrhage, or thrombosis of the deep venous system) were included. Data were analyzed according to the intention-to-treat principle from March 2018 to February 2019. The trial was halted after the first interim analysis for reasons of futility.
Interventions


Patients were randomized to receive either EVT with standard medical care (intervention group) or guideline-based standard medical care only (control group). The EVT consisted of mechanical thrombectomy, local intrasinus application of alteplase or urokinase, or a combination of both strategies. Patients in the intervention group underwent EVT as soon as possible but no later than 24 hours after randomization.
Main Outcomes and Measures


Primary end point was the proportion of patients with a good outcome at 12 months (recovered without a disability; modified Rankin Scale [mRS] score of 0-1). Secondary end points were the proportion of patients with an mRS score of 0 to 1 at 6 months and an mRS score of 0 to 2 at 6 and 12 months, outcome on the mRS across the ordinal continuum at 12 months, recanalization rate, and surgical interventions in relation to CVT. Safety end points included symptomatic intracranial hemorrhage.
Results


Of the 67 patients enrolled and randomized, 33 (49%) were randomized to the intervention group and 34 (51%) were randomized to the control group. Patients in the intervention group vs those in the control group were slightly older (median [interquartile range (IQR)] age, 43 [33-50] years vs 38 [23-48] years) and comprised fewer women (23 women [70%] vs 27 women [79%]). The median (IQR) baseline National Institutes of Health Stroke Scale score was 12 (7-20) in the EVT group and 12 (5-20) in the standard care group. At the 12-month follow-up, 22 intervention patients (67%) had an mRS score of 0 to 1 compared with 23 control patients (68%) (relative risk ratio, 0.99; 95% CI, 0.71-1.38). Mortality was not statistically significantly higher in the EVT group (12% [n = 4] vs 3% [n = 1]; P = .20). The frequency of symptomatic intracerebral hemorrhage was not statistically significantly lower in the intervention group (3% [n = 1] vs 9% [n = 3]; P = .61).
Conclusions and Relevance


The TO-ACT trial showed that EVT with standard medical care did not appear to improve functional outcome of patients with CVT. Given the small sample size, the possibility exists that future studies will demonstrate better recovery rates after EVT for this patient population.
Trial Registration


ClinicalTrials.gov Identifier: NCT01204333.",2020,The frequency of symptomatic intracerebral hemorrhage was not statistically significantly lower in the intervention group (3% [n = 1],"['patients with a severe form of CVT', '8 hospitals in 3 countries (the Netherlands, China, and Portugal', 'Adult patients with radiologically confirmed CVT who had at least 1 risk factor for a poor outcome (mental status disorder, coma state, intracerebral hemorrhage, or thrombosis of the deep venous system) were included', 'Severe Cerebral Venous Thrombosis', 'patients with CVT', '67 patients enrolled and randomized, 33 (49%) were randomized to the intervention group and 34 (51', 'Patients were recruited from September 2011 to October 2016, and follow-up began in March 2012 and was completed in December 2017', 'patients with cerebral venous thrombosis (CVT']","['ACT (Thrombolysis or Anticoagulation', 'alteplase or urokinase', 'EVT with standard medical care (intervention group) or guideline-based standard medical care only (control group', 'EVT', 'endovascular treatment (EVT', 'Endovascular Treatment With Medical Management vs Standard Care']","['frequency of symptomatic intracerebral hemorrhage', 'functional outcome', 'proportion of patients with an mRS score of 0 to 1 at 6 months and an mRS score', 'recanalization rate, and surgical interventions in relation to CVT', 'efficacy and safety', 'symptomatic intracranial hemorrhage', 'mRS score', 'proportion of patients with a good outcome at 12 months (recovered without a disability; modified Rankin Scale [mRS] score of 0-1', 'median (IQR) baseline National Institutes of Health Stroke Scale score', 'Mortality', 'slightly older']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0151945', 'cui_str': 'Thrombosis of cerebral veins'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0947967', 'cui_str': 'Coma states'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1267406', 'cui_str': 'Venous system structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0042071', 'cui_str': 'Urokinase'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0151945', 'cui_str': 'Thrombosis of cerebral veins'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",67.0,0.10781,The frequency of symptomatic intracerebral hemorrhage was not statistically significantly lower in the intervention group (3% [n = 1],"[{'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Susanna M', 'Initials': 'SM', 'LastName': 'Zuurbier', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Marie-Germaine', 'Initials': 'MG', 'LastName': 'Bousser', 'Affiliation': 'Department of Neurology, Hôpital Lariboisière, Paris, France.'}, {'ForeName': 'Xunming', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Department of Interventional Radiology, XuanWu Hospital, Beijing, China.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Canhão', 'Affiliation': 'Serviço de Neurologia, Instituto de Medicina Molecular, Hospital Santa Maria/Centro Hospitalar Lisboa Norte, Department of Neurosciences and Mental Health, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Yvo B', 'Initials': 'YB', 'LastName': 'Roos', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Crassard', 'Affiliation': 'Department of Neurology, Hôpital Lariboisière, Paris, France.'}, {'ForeName': 'Ana Paiva', 'Initials': 'AP', 'LastName': 'Nunes', 'Affiliation': 'Department of Neurology, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Uyttenboogaart', 'Affiliation': 'Department of Neurology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Interventional Radiology, XuanWu Hospital, Beijing, China.'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Emmer', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Roosendaal', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Houdart', 'Affiliation': 'Department of Neuroradiology, Hôpital Lariboisière, Paris, France.'}, {'ForeName': 'Jim A', 'Initials': 'JA', 'LastName': 'Reekers', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'van den Berg', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'de Haan', 'Affiliation': 'Clinical Research Unit, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Ferro', 'Affiliation': 'Serviço de Neurologia, Instituto de Medicina Molecular, Hospital Santa Maria/Centro Hospitalar Lisboa Norte, Department of Neurosciences and Mental Health, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stam', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2020.1022']
2200,32421171,Mind-Body Therapy via Videoconferencing in Patients With Neurofibromatosis: Analyses of 1-Year Follow-up.,"BACKGROUND


Neurofibromatosis (NF) is a rare genetic disorder associated with substantial deficits in quality of life (QoL). We have previously shown that in this population the Relaxation Response Resiliency Program for NF (3RP-NF) delivered via live videoconferencing is associated with sustained improvement in QoL from baseline through 6-month follow-up over and above an attention placebo control..
PURPOSE


To examine between- and within-group changes in QoL domains from baseline to 1-year follow-up and 6-month to 1-year follow-up.
METHODS


We enrolled and randomized 63 adults with NF. Of these, 52 completed the 6-month follow-up and 53 completed 1-year follow-up. We assessed QoL with the World Health Organization Quality of Life-Brief.
RESULTS


Participation in the 3RP-NF was associated with sustained improvement from baseline to 1 year in physical health QoL (12.68; 95% confidence interval [CI]: 1.76 to 23.59; p =.024) and social relations QoL (16.81; 95% CI: 3.03 to 30.59; p =.018) but not psychological and environmental QoL, over and above the control (between group changes). Participants in the 3RP-NF improved from baseline to 1 year in psychological (8.16; 95% CI: 1.17 to 15.14; p =.023) and social relations QoL (9.93; 95% CI: 1.10 to 18.77; p = .028; within-group changes). There were no other significant differences between or within groups from baseline/6 months to 1 year.
CONCLUSIONS


The live video 3RP-NF shows promise in improving QoL dimensions over the course of 1 year. Results should be replicated in a fully powered randomized controlled trial.
CLINICAL TRIAL INFORMATION


ClinicalTrials.gov NCT03406208.",2020,"RESULTS


Participation in the 3RP-NF was associated with sustained improvement from baseline to 1 year in physical health QoL (12.68; 95% confidence interval [CI]: 1.76 to 23.59; p =.024) and social relations QoL (16.81; 95% CI: 3.03 to 30.59; p =.018) but not psychological and environmental QoL, over and above the control (between group changes).","['Patients With Neurofibromatosis', 'We enrolled and randomized 63 adults with NF']",['Mind-Body Therapy via Videoconferencing'],"['social relations QoL', 'QoL dimensions', 'QoL with the World Health Organization Quality of Life-Brief', 'QoL domains']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0260173', 'cui_str': 'Mind-Body Therapies'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",63.0,0.181463,"RESULTS


Participation in the 3RP-NF was associated with sustained improvement from baseline to 1 year in physical health QoL (12.68; 95% confidence interval [CI]: 1.76 to 23.59; p =.024) and social relations QoL (16.81; 95% CI: 3.03 to 30.59; p =.018) but not psychological and environmental QoL, over and above the control (between group changes).","[{'ForeName': 'Ethan G', 'Initials': 'EG', 'LastName': 'Lester', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, Boston, MA, USA.'}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Gates', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, Boston, MA, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, Boston, MA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa030']
2201,32421193,Ethnic Differences in Experimental Pain Responses Following a Paired Verbal Suggestion With Saline Infusion: A Quasiexperimental Study.,"BACKGROUND


Ethnic differences in placebo and nocebo responses are an important, yet underresearched, patient factor that might contribute to treatment disparities.
PURPOSE


The purpose of this study was to examine ethnic differences in pain trajectories following a verbal suggestion paired with a masked, inert substance (i.e., saline).
METHODS


Using a quasiexperimental design, we examined differences between 21 non-Hispanic Black (NHB) participants and 20 non-Hispanic White (NHW) participants in capsaicin-related pain rating trajectories following a nondirectional verbal suggestion + saline infusion. All participants were told that the substance would ""either increase pain sensation, decrease it, or leave it unchanged."" A spline mixed model was used to quantify the interaction of ethnicity and time on ratings.
RESULTS


There was a significant Ethnicity × Time interaction effect (β = -0.28, p = .002); NHB individuals reported significantly greater increases in pain following, but not before, the verbal suggestion + saline infusion. Sensitivity analyses showed no change in primary results based on differences in education level, general pain sensitivity, or condition order.
CONCLUSIONS


The present results showed ethnic differences in pain response trajectories following a verbal suggestion + saline infusion and suggest that future research rigorously examining possible ethnic differences in placebo/nocebo responses is warranted.",2020,"There was a significant Ethnicity × Time interaction effect (β = -0.28, p = .002); NHB individuals reported significantly greater increases in pain following, but not before, the verbal suggestion + saline infusion.",['21 non-Hispanic Black (NHB) participants and 20 non-Hispanic White (NHW) participants in capsaicin-related pain rating trajectories following a'],"['nondirectional verbal suggestion + saline infusion', 'verbal suggestion paired with a masked, inert substance (i.e., saline', 'placebo']","['Experimental Pain Responses', 'pain response trajectories', 'pain sensation', 'pain', 'education level, general pain sensitivity, or condition order', 'pain trajectories']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]",,0.251549,"There was a significant Ethnicity × Time interaction effect (β = -0.28, p = .002); NHB individuals reported significantly greater increases in pain following, but not before, the verbal suggestion + saline infusion.","[{'ForeName': 'Janelle E', 'Initials': 'JE', 'LastName': 'Letzen', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine, Nathan Shock Drive, Suite, Baltimore, MD, USA.'}, {'ForeName': 'Troy C', 'Initials': 'TC', 'LastName': 'Dildine', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Chung Jung', 'Initials': 'CJ', 'LastName': 'Mun', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine, Nathan Shock Drive, Suite, Baltimore, MD, USA.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bruehl', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine, Nathan Shock Drive, Suite, Baltimore, MD, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa032']
2202,32421218,"Dissolving microneedle with high molecular weight hyaluronic acid to improve skin wrinkles, dermal density and elasticity.","OBJECTIVES


Dissolving microneedle patches have been extensively studied in the field of cosmetics comparison with topical cosmetics focusing on the delivery of active ingredients. Nevertheless, the skin improvement effect of hyaluronic acid, which is mainly used as a backbone material for dissolving microneedle, was not analyzed. In this study, adenosine encapsulated high and low molecular weight hyaluronic acid dissolving microneedle patch (Ad-HMN and Ad-LMN) were evaluated with respect to skin wrinkling, dermal density, elasticity, and safety in a clinical test on the crow's feet area.
METHODS


Clinical efficacy and safety tests were performed for 12 weeks on twenty three female subjects with wrinkles around their eyes. The Ad-HMN and Ad-LMN patch were applied once every 3 days, in the evening, for 8 weeks to the designated crow's feet area. Skin wrinkling, dermal density, and elasticity were measured by using PRIMOS ®  premium, Dermascan ®  C, Cutometer ®  MPA580, and Corneometer ®  CM 825, respectively.
RESULTS


Both Ad-HMN and Ad-LMN groups showed statistically significant efficacy for almost all parameters. The Ad-HMN patch had better effect on the mean depth of biggest wrinkles, maximum depth of biggest wrinkles, dermal density, and skin elasticity than the Ad-LMN patch. No adverse effects were observed in either group during the test period.
CONCLUSION


In the clinical efficacy test of four skin-improvement parameters, the Ad-HMN patch showed the better effect than the Ad-LMN patch with the similar adenosine dose.",2020,"METHODS


Clinical efficacy and safety tests were performed for 12 weeks on twenty three female subjects with wrinkles around their eyes.",['12\xa0weeks on twenty three female subjects with wrinkles around their eyes'],"['Ad-HMN and Ad-LMN patch', 'hyaluronic acid dissolving microneedle patch (Ad-HMN and Ad-LMN', 'hyaluronic acid', 'Ad-HMN and Ad-LMN']","['skin wrinkles, dermal density and elasticity', 'adverse effects', 'Skin wrinkling, dermal density, and elasticity', 'mean depth of biggest wrinkles, maximum depth of biggest wrinkles, dermal density, and skin elasticity']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0230064', 'cui_str': 'Periorbital'}]","[{'cui': 'C4038906', 'cui_str': 'Hmong language'}, {'cui': 'C1851710', 'cui_str': 'Lateral meningocele syndrome'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C1549535', 'cui_str': 'Dissolve'}]","[{'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0423761', 'cui_str': 'Skin elasticity'}]",23.0,0.0212318,"METHODS


Clinical efficacy and safety tests were performed for 12 weeks on twenty three female subjects with wrinkles around their eyes.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jang', 'Affiliation': 'Department of Biotechnology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Baek', 'Affiliation': 'Juvic Inc, 272 Digital-ro, Guro-gu, Seoul, 08389, Korea.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kang', 'Affiliation': 'Department of Biotechnology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Juvic Inc, 272 Digital-ro, Guro-gu, Seoul, 08389, Korea.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Biotechnology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jung', 'Affiliation': 'Department of Biotechnology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea.'}]",International journal of cosmetic science,['10.1111/ics.12617']
2203,32421226,Bevacizumab plus chemotherapy in nonsquamous non-small cell lung cancer patients with malignant pleural effusion uncontrolled by tube drainage or pleurodesis: A phase II study North East Japan Study group trial NEJ013B.,"BACKGROUND


Pleurodesis is the standard of care for non-small cell lung cancer (NSCLC) patients with symptomatic malignant pleural effusion (MPE). However, there is no standard management for MPE uncontrolled by pleurodesis. Most patients with unsuccessful MPE control are unable to receive effective chemotherapy. Vascular endothelial growth factor (VEGF) plays an important role in the pathogenesis of MPE. This multicenter, phase II study investigated the effects of bevacizumab plus chemotherapy in nonsquamous NSCLC patients with unsuccessful management of MPE.
METHODS


Nonsquamous NSCLC patients with MPE following unsuccessful tube drainage or pleurodesis received bevacizumab (15 mg/kg) plus chemotherapy every three weeks. The primary endpoint was pleural effusion control rate (PECR), defined as the percentage of patients without reaccumulation of MPE at eight weeks. Secondary endpoints included pleural progression-free survival (PPFS), safety, and quality of life (QoL).
RESULTS


A total of 20 patients (median age: 69 years; 14 males; 20 adenocarcinomas; six epidermal growth factor receptor mutations) were enrolled in nine centers. The PECR was 80% and the primary end point was met. The PPFS and the overall survival (OS) were 16.6 months and 19.6 months, respectively. Patients with high levels of VEGF in the MPE had shorter PPFS (P = 0.010) and OS (P = 0.002). Toxicities of grade ≥ 3 included neutropenia (50%), thrombocytopenia (10%), proteinuria (10%), and hypertension (2%). The cognitive QoL score improved after treatment.
CONCLUSIONS


Bevacizumab plus chemotherapy is highly effective with acceptable toxicities in nonsquamous NSCLC patients with uncontrolled MPE, and should be considered as a standard therapy in this setting.
KEY POINTS


SIGNIFICANT FINDINGS OF THE STUDY: Bevacizumab plus chemotherapy is highly effective with acceptable toxicities in nonsquamous NSCLC patients with uncontrolled MPE.
WHAT THIS STUDY ADDS


Bevacizumab plus chemotherapy should be considered as a standard treatment option for patients with uncontrolled MPE.
CLINICAL TRIAL REGISTRATION


UMIN000006868 was a phase II study of efficacy of bevacizumab plus chemotherapy for the management of malignant pleural effusion (MPE) in nonsquamous non-small cell lung cancer patients with MPE unsuccessfully controlled by tube drainage or pleurodesis (North East Japan Study Group Trial NEJ-013B) (http://umin.sc.jp/ctr/).",2020,Patients with high levels of VEGF in the MPE had shorter PPFS (P = 0.010) and OS (P = 0.002).,"['nonsquamous NSCLC patients with unsuccessful management of MPE', 'Nonsquamous NSCLC patients with MPE following unsuccessful tube drainage or pleurodesis received', 'nonsquamous non-small cell lung cancer patients with MPE unsuccessfully controlled by', '20 patients (median age: 69\u2009years; 14 males; 20 adenocarcinomas; six epidermal growth factor receptor mutations) were enrolled in nine centers', 'nonsquamous non-small cell lung cancer patients with malignant pleural effusion uncontrolled by tube drainage or pleurodesis', 'non-small cell lung cancer (NSCLC) patients with symptomatic malignant pleural effusion (MPE', 'nonsquamous NSCLC patients with uncontrolled MPE', 'patients with uncontrolled MPE']","['tube drainage or pleurodesis', 'Bevacizumab plus chemotherapy', 'bevacizumab', 'bevacizumab plus chemotherapy']","['cognitive QoL score', 'thrombocytopenia', 'shorter PPFS', 'pleural progression-free survival (PPFS), safety, and quality of life (QoL', 'Toxicities of grade\u2009≥\u20093 included neutropenia', 'pleural effusion control rate (PECR), defined as the percentage of patients without reaccumulation of MPE', 'overall survival (OS']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0080032', 'cui_str': 'Neoplastic pleural effusion'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0080032', 'cui_str': 'Neoplastic pleural effusion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",20.0,0.123536,Patients with high levels of VEGF in the MPE had shorter PPFS (P = 0.010) and OS (P = 0.002).,"[{'ForeName': 'Rintaro', 'Initials': 'R', 'LastName': 'Noro', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Respiratory medicine, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Usuki', 'Affiliation': 'Department of Pulmonary Medicine, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Yomota', 'Affiliation': 'Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Nishitsuji', 'Affiliation': 'Department of Respiratory Medicine, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.'}, {'ForeName': 'Tsuneo', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': ""Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.""}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Internal Medicine, Jizankai Medical Foundation Tsuboi Cancer Center Hospital, Fukushima, Japan.'}, {'ForeName': 'Mitsunori', 'Initials': 'M', 'LastName': 'Hino', 'Affiliation': 'Department of Pulmonary Medicine, Nippon Medical School Chiba Hokuso Hospital, Chiba, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hagiwara', 'Affiliation': 'Division of Pulmonary Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Miyanaga', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Seike', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Gemma', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thoracic cancer,['10.1111/1759-7714.13472']
2204,32416981,Are narcotic pain medications necessary after discharge following thyroidectomy and parathyroidectomy?,"BACKGROUND


The aim of this study was to determine whether patients undergoing thyroidectomy and parathyroidectomy have similar postoperative pain if managed with an opioid-sparing regimen versus an opioid-containing regimen. We hypothesized that an opioid-sparing regimen would provide equivalent analgesia.
METHODS


We performed a prospective, randomized trial (clinicaltrials.govNCT03640247) comparing non-narcotic and narcotic postoperative pain regimens after discharge. Patients ≥18 y undergoing thyroidectomy or parathyroidectomy were eligible for inclusion. Patients were excluded if they were taking a narcotic. Patients in the nonnarcotic arm of the study received acetaminophen, alternating with ibuprofen, and patients in the narcotic arm received the same medications plus a narcotic.
RESULTS


Of 126 patients, 64 patients were in the nonnarcotic group and 62 were in the narcotic group. The mean age was 54 ± 14 y, and 108 (86%) patients were female. Median pain scores were similar on postoperative day #0 (narcotic group 7 versus nonnarcotic group 7.5), postoperative day #1 (narcotic group 6 versus nonnarcotic group 6), postoperative day #2 (narcotic group 5 versus nonnarcotic group 5), postoperative day #3 (narcotic group 4 versus nonnarcotic group 4), postoperative day #4 (narcotic group 3 versus nonnarcotic 3) and postoperative day #5 (narcotic group 2.5 versus nonnarcotic group 2, all P > .1). A total of 31 (50%) patients in the narcotic group did not take a narcotic. A total of 8 (12.5%) patients in the nonnarcotic group and of 31 (50%) patients in the narcotic group took a median total of 2 narcotic tablets.
CONCLUSION


An opioid-sparing pain medication regimen provides effective analgesia for most patients after thyroidectomy and parathyroidectomy.",2020,"Median pain scores were similar on postoperative day #0 (narcotic group 7 versus nonnarcotic group 7.5), postoperative day #1 (narcotic group 6 versus nonnarcotic group 6), postoperative day #2 (narcotic group 5 versus nonnarcotic group 5), postoperative day #3 (narcotic group 4 versus nonnarcotic group 4), postoperative day #4 (narcotic group 3 versus nonnarcotic 3) and postoperative day #5 (narcotic group 2.5 versus nonnarcotic group 2, all P > .1).","['64 patients were in the nonnarcotic group and 62 were in the narcotic group', 'non-narcotic and narcotic postoperative pain regimens after discharge', 'Patients ≥18 y undergoing thyroidectomy or parathyroidectomy were eligible for inclusion', 'The mean age was 54 ± 14 y, and 108 (86%) patients were female', 'patients undergoing', '126 patients']","['opioid-sparing regimen versus an opioid-containing regimen', 'acetaminophen, alternating with ibuprofen', 'narcotic arm received the same medications plus a narcotic', 'thyroidectomy and parathyroidectomy', 'opioid-sparing pain medication regimen', 'opioid-sparing regimen']",['Median pain scores'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",64.0,0.0398099,"Median pain scores were similar on postoperative day #0 (narcotic group 7 versus nonnarcotic group 7.5), postoperative day #1 (narcotic group 6 versus nonnarcotic group 6), postoperative day #2 (narcotic group 5 versus nonnarcotic group 5), postoperative day #3 (narcotic group 4 versus nonnarcotic group 4), postoperative day #4 (narcotic group 3 versus nonnarcotic 3) and postoperative day #5 (narcotic group 2.5 versus nonnarcotic group 2, all P > .1).","[{'ForeName': 'Justin T', 'Initials': 'JT', 'LastName': 'Brady', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Dreimiller', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Miller-Spalding', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Gesang', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Ashwini R', 'Initials': 'AR', 'LastName': 'Sehgal', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'McHenry', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA. Electronic address: cmchenry@metrohealth.org.'}]",Surgery,['10.1016/j.surg.2020.03.027']
2205,32417119,Impact of a Capacity-Building Intervention on Food Marketing Features in Recreation Facilities.,"OBJECTIVE


To explore the impact of a capacity-building intervention (CBI) to support implementing provincial nutrition guidelines on food marketing in recreation facilities (RFs).
DESIGN


Randomized controlled trial within a natural experiment: food marketing in RFs from 3 guideline provinces randomly assigned to intervention (GL+CBI) or comparison (GL-ONLY) was compared with facilities in 1 province without guidelines (NO-GL). Food marketing was assessed by the Food and Beverage Marketing Assessment Tool for Settings.
SETTING


Canadian provinces with/without voluntary nutrition guidelines for RFs.
PARTICIPANTS


51 RFs.
INTERVENTION


18-month CBI.
MAIN OUTCOME MEASURES


Change in Food and Beverage Marketing Assessment Tool for Settings scores and marketing features between baseline and follow-up across groups.
ANALYSIS


Kruskal-Wallis with post hoc Mann-Whitney U tests.
RESULTS


No significant differences in food marketing features between baseline and follow-up across groups except for a change in food marketing frequency (P = .045). The increase in frequency in NO-GL (median, 6.0; interquartile range, -2.0 to 8.5) was significantly greater than changes in the GL+CBI (P = .033) and GL-ONLY sites (P = .049).
CONCLUSIONS AND IMPLICATIONS


Capacity-building was not associated with improved food marketing features potentially because of nonmandated nutrition guidelines, low priority for change, and vague or narrow facility goals and guidelines. Nutrition guidelines with specific unhealthy food marketing restrictions should be mandated and supported.",2020,No significant differences in food marketing features between baseline and follow-up across groups except for a change in food marketing frequency (P = .045).,"['51 RFs', 'recreation facilities (RFs', 'Recreation Facilities', 'Canadian provinces with/without voluntary nutrition guidelines for RFs']","['intervention (GL+CBI) or comparison (GL-ONLY', 'capacity-building intervention (CBI', 'Capacity-Building Intervention']","['food marketing features', 'frequency in NO-GL', 'food marketing frequency', 'Change in Food and Beverage Marketing Assessment Tool for Settings scores and marketing features']","[{'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C3658297', 'cui_str': 'Dietary Guidelines'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2718026', 'cui_str': 'Capacity Building'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0024826', 'cui_str': 'Marketing'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",51.0,0.0773804,No significant differences in food marketing features between baseline and follow-up across groups except for a change in food marketing frequency (P = .045).,"[{'ForeName': 'Rachel J L', 'Initials': 'RJL', 'LastName': 'Prowse', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada. Electronic address: prowse@ualberta.ca.'}, {'ForeName': 'Patti-Jean', 'Initials': 'PJ', 'LastName': 'Naylor', 'Affiliation': 'School of Exercise Science, Physical and Health Education, University of Victoria, Victoria, British Columbia, Canada.'}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Olstad', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Storey', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Carson', 'Affiliation': 'Faculty of Physical Education and Recreation, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Louise C', 'Initials': 'LC', 'LastName': 'Mâsse', 'Affiliation': ""BC Children's Hospital Research Institute, School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Sara F L', 'Initials': 'SFL', 'LastName': 'Kirk', 'Affiliation': 'Healthy Populations Institute, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Raine', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.03.009']
2206,32417345,Randomized controlled trial to identify the optimal radiotherapy scheme for palliative treatment of incurable head and neck squamous cell carcinoma.,"BACKGROUND


No randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL).
MATERIALS AND METHODS


Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week).
RESULTS


The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p=0.450, HR=0.56, 95%CI 0.12-2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p=0.215, HR=0.55, 95%CI 0.21-1.43). Acute grade ≥3 toxicity was lower in arm 1 (16.7% versus 57.1%, p=0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p=0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found.
CONCLUSION


No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power.",2020,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"['patients with incurable head and neck squamous cell carcinoma (HNSCC', 'incurable head and neck squamous cell carcinoma', 'Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease']",[],"['grade 3 mucositis', 'QoL-scores', 'efficacy, toxicity and quality-of-life (QoL', 'Acute grade ≥3 toxicity', 'median time to loco-regional progression', 'QoL-scales', 'overall survival', 'loco-regional control rates', 'acute grade 3 mucositis', 'oncologic outcomes', 'Objective response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],"[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",34.0,0.193028,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"[{'ForeName': 'Abrahim', 'Initials': 'A', 'LastName': 'Al-Mamgani', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: a.almamgani@nki.nl.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Kessels', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelia G', 'Initials': 'CG', 'LastName': 'Verhoef', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Navran', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Hamming-Vrieze', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes H A M', 'Initials': 'JHAM', 'LastName': 'Kaanders', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Roel J H M', 'Initials': 'RJHM', 'LastName': 'Steenbakkers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tans', 'Affiliation': 'Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hoebers', 'Affiliation': 'Department of Radiation Oncology (MAASTRO clinic), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht 6229 ET, Netherlands.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Ong', 'Affiliation': 'Department of Radiation Oncology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Werkhoven', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes A', 'Initials': 'JA', 'LastName': 'Langendijk', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.020']
2207,32417564,Sham Surgery Studies in Orthopedic Surgery May Just Be a Sham: A Systematic Review of Randomized Placebo-Controlled Trials.,"PURPOSE


To determine the limitations of randomized sham surgery-controlled trials in orthopedic sports medicine and fidelity of the trials' conclusions.
METHODS


Randomized placebo surgery-controlled trials in orthopedic sports medicine were included in this PRISMA-guided systematic review. Several aspects of investigation design and conduct were analyzed: genetic analysis for propensity to placebo response, equipoise of informed consent process, geography of trial subjects, percentage of eligible subjects willing to be randomized, changes from protocol publication to results publication, and perioperative complications.
RESULTS


Seven sham surgery-controlled trials (845 subjects [370 knees, 449 shoulders, 26 elbows]; five Europe, one North America, one Australia; all superiority model, efficacy design) were analyzed. There were consistent methodological deficiencies across studies. No studies reported genetic analysis of susceptibility to placebo response. Three studies (43%) were underpowered. Crossover rates ranged from 8% to 36% that led to un-blinding in up to 100% of subjects. There were low enrollment rates of eligible subjects (up to 57% refused randomization). Follow-up was short-term (two years or less in all but one study). Complication rates ranged from 0% to 12.5% with complications occurring in both groups (no significant difference between groups in any study).
CONCLUSION


Randomized sham-controlled studies in orthopaedic sports medicine have significant methodological deficiencies that may invalidate their conclusions. Randomized trial design (with or without placebo control) may be optimized through the inclusion of per-protocol analysis, blinding index, equivalence or non-inferiority trial design, and a non-treatment group.",2020,"Complication rates ranged from 0% to 12.5% with complications occurring in both groups (no significant difference between groups in any study).
","['orthopedic sports medicine', 'Seven sham surgery-controlled trials (845 subjects [370 knees, 449 shoulders, 26 elbows]; five Europe, one North America, one Australia', 'Orthopedic Surgery']","['Placebo', 'placebo']",['Complication rates'],"[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}]",845.0,0.715691,"Complication rates ranged from 0% to 12.5% with complications occurring in both groups (no significant difference between groups in any study).
","[{'ForeName': 'Kyle R', 'Initials': 'KR', 'LastName': 'Sochacki', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, 6445 Main Street, Suite 2500, Houston, Texas 77030, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Mather', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Benedict U', 'Initials': 'BU', 'LastName': 'Nwachukwu', 'Affiliation': 'Hospital for Special Surgery, New York, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dong', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, 6445 Main Street, Suite 2500, Houston, Texas 77030, USA.'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'Nho', 'Affiliation': 'Section of Young Adult Hip Surgery, Division of Sports Medicine, Department of Orthopedic Surgery, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Cote', 'Affiliation': 'UConn Musculoskeletal Institute at UConn Health, Farmington, CT, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Harris', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, 6445 Main Street, Suite 2500, Houston, Texas 77030, USA. Electronic address: joshuaharrismd@gmail.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.05.001']
2208,32417629,"Melatonin supplementation and the effects on clinical and metabolic status in Parkinson's disease: A randomized, double-blind, placebo-controlled trial.","OBJECTIVE


This study was performed to evaluate the impact of melatonin supplementation on clinical and metabolic profiles in people with Parkinson's disease (PD).
METHODS


This randomized, double-blind, placebo-controlled clinical trial was conducted among 60 patients with PD. Participants were randomly divided into two groups to intake either 10 mg melatonin (two melatonin capsules, 5 mg each) (n = 30) or placebo (n = 30) once a day, 1 h before bedtime for 12 weeks.
RESULTS


Melatonin supplementation significantly reduced the Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β -2.33; 95% CI, -3.57, -1.09; P < 0.001), Pittsburgh Sleep Quality Index (PSQI) (β -1.82; 95% CI, -3.36, -0.27; P = 0.02), Beck Depression Inventory (BDI) (β -3.32; 95% CI, -5.23, -1.41; P = 0.001) and Beck Anxiety Inventory (BAI) (β -2.22; 95% CI, -3.84, -0.60; P = 0.008) compared with the placebo treatment. Compared with the placebo, melatonin supplementation resulted in a significant reduction in serum high sensitivity C-reactive protein (hs-CRP) (β -0.94 mg/L; 95% CI, -1.55, -0.32; P = 0.003) and a significant elevation in plasma total antioxidant capacity (TAC) (β 108.09 mmol/L; 95% CI, 78.21, 137.97; P < 0.001) and total glutathione (GSH) levels (β 77.08 μmol/L; 95% CI, 44.29, 109.86; P < 0.001). Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β -13.16 mg/dL; 95% CI, -25.14, -1.17; P = 0.03) and LDL- (β -10.44 mg/dL; 95% CI, -20.55, -0.34; P = 0.04) compared with the placebo.
CONCLUSIONS


Overall, melatonin supplementation for 12 weeks to patients with PD had favorable effects on the UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR, but did not affect other metabolic profiles.",2020,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[""Parkinson's disease"", ""people with Parkinson's disease (PD"", '60 patients with PD']","['melatonin supplementation', 'Melatonin supplementation', 'placebo, melatonin supplementation', 'melatonin (two melatonin capsules', 'placebo']","['Pittsburgh Sleep Quality Index (PSQI', 'homeostasis model of assessment-insulin resistance (HOMA-IR', 'UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR', 'serum high sensitivity C-reactive protein (hs-CRP', 'plasma total antioxidant capacity (TAC', 'total glutathione (GSH) levels', 'LDL', 'Beck Anxiety Inventory (BAI) ', 'Beck Depression Inventory (BDI', 'serum insulin levels', ""Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0034821', 'cui_str': 'LDL receptor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}]",60.0,0.782673,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Daneshvar Kakhaki', 'Affiliation': 'Autoimmune Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Infectious Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran; Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran; Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Omid Reza', 'Initials': 'OR', 'LastName': 'Tamtaji', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'J Reiter', 'Affiliation': 'Department of Cellular and Structural Biology, University of Texas Health Science, Center, San Antonio, TX, USA.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_z@Kaums.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105878']
2209,32417634,"Supplemental selenium and coenzyme Q10 reduce glycation along with cardiovascular mortality in an elderly population with low selenium status - A four-year, prospective, randomised, double-blind placebo-controlled trial.","BACKGROUND


A low intake of selenium has been shown to increase the risk of cardiovascular mortality, and supplementation of selenium and coenzyme Q10 influences this. The mechanism behind is unclear although effects on inflammation, oxidative stress and microRNA expression have been reported. Fructosamine, a marker of long-term glycaemic control, is also a marker of increased risk of heart disease and death, even in non-diabetics.
OBJECTIVE


To analyse the impact of selenium and coenzyme Q10 supplementation on the concentration of fructosamine. Also, the relation between pre-intervention serum selenium concentration and the effect on fructosamine of the intervention was studied.
METHODS


Fructosamine plasma concentration was determined in 219 participants after six and 42 months of intervention with selenium yeast (200 μg/day) and coenzyme Q10 (200 mg/ day) (n = 118 of which 20 had diabetes at inclusion), or placebo (n = 101 of which 18 had diabetes at inclusion). Pre-intervention, the serum selenium levels were 67 μg/L (active treatment group: 66.6 μg/L; placebo group: 67.4 μg/L), corresponding to an estimated intake of 35 μg/day. Changes in concentrations of fructosamine following intervention were assessed by the use of T-tests, repeated measures of variance, and ANCOVA analyses.
RESULTS


Post-intervention selenium concentrations were 210 μg/L in the active group and 72 μg/L in the placebo group. A lower concentration of fructosamine could be seen as a result of the intervention in the total population (P = 0.001) in both the males (P = 0.04) and in the females (P = 0.01) in the non-diabetic population (P = 0.002), and in both the younger (<76 years) (P = 0.01) and the older (≥76 years) participants (P = 0.03). No difference could be demonstrated in fructosamine concentration in the diabetic patients, but the total sample was small (n = 38). In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level.
CONCLUSION


A significantly lower concentration of fructosamine was observed in the elderly community-living participants supplemented with selenium and coenzyme Q10 for 42 months compared to those on the placebo. As oxidative mechanisms are involved in the glycation of proteins, less glycoxidation could be a result of the supplementation of selenium and coenzyme Q10, which could have contributed to lower cardiac mortality and less inflammation, as has earlier been reported. This study was registered at Clinicaltrials.gov, and has the identifier NCT01443780.",2020,"In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level.
","['219 participants after six and 42 months of intervention with selenium yeast (200\u202fμg/day) and', 'elderly population with low selenium status - A four-year', '\u202f101 of which 18 had diabetes at inclusion']","['Fructosamine', 'selenium and coenzyme Q10', 'coenzyme Q10 ', 'selenium and coenzyme Q10 supplementation', 'placebo (n', 'Supplemental selenium and coenzyme Q10 reduce glycation', 'placebo']","['serum selenium levels', 'fructosamine', 'concentration of fructosamine', 'fructosamine concentration']","[{'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0455308', 'cui_str': 'Serum selenium measurement'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",219.0,0.328184,"In subjects with a low pre-intervention level of serum selenium the intervention gave a more pronounced decrease in fructosamine compared with those with a higher baseline selenium level.
","[{'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Alehagen', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University, SE-581 85 Linköping, Sweden. Electronic address: Urban.Alehagen@liu.se.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Aaseth', 'Affiliation': 'Research Department, Innlandet Hospital Trust, N-2381 Brumunddal, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Alexander', 'Affiliation': 'Norwegian Institute of Public Health, P.O. Box 222 Skøyen, N-0213 Oslo, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Johansson', 'Affiliation': 'Department of Social and Welfare studies. Department of Medical and Health Sciences, Linköping University, SE-601 74 Norrköping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, SE-751 85 Uppsala, Sweden.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126541']
2210,32417925,A Randomized Trial to Compare Serratus Anterior Plane Block and Erector Spinae Plane Block for Pain Management Following Thoracoscopic Surgery.,"OBJECTIVE


Comparison of ultrasound (US)-guided erector spinae plane block (ESPB) and serratus anterior plane block (SAPB) in video-assisted thoracic surgery (VATS) patients. The primary outcome was to compare perioperative and postoperative (48 hours) opioid consumption.
METHODS


A total of 60 patients were randomized into two groups (N = 30): an ESPB group and an SAPB group. All the patients received intravenous patient-controlled postoperative analgesia and ibuprofen 400 mg intravenously every eight hours. Visual analog scale (VAS) scores, opioid consumption, and adverse events were recorded.
RESULTS


Intraoperative and postoperative opioid consumption at 0-8, 8-16, and 16-24 hours and rescue analgesic use were significantly lower in the ESPB group (P < 0.05). Static/dynamic VAS scores were significantly lower in the ESPB group (P < 0.05). There was no significant difference between static VAS scores at the fourth hour. There were no differences between adverse effects. Block procedure time and one-time puncture success were similar between groups (P  > 0.05 each).
CONCLUSION


US-guided ESPB may provide better pain control than SAPB after VATS.
QUESTION


Even though there are studies about analgesia management after VATS, clinicians want to perform the technique that is both less invasive and more effective.
FINDINGS


This randomized trial showed that US-guided ESPB provides effective analgesia compared with SAPB.
MEANING


Performing single-injection ESPB reduces VAS scores and opioid consumption compared with SAPB.",2020,Static/dynamic VAS scores were significantly lower in the ESPB group (P < 0.05).,"['Pain Management Following Thoracoscopic Surgery', '60 patients', 'video-assisted thoracic surgery (VATS) patients']","['Serratus Anterior Plane Block and Erector Spinae Plane Block', 'ESPB', 'US-guided ESPB', 'intravenous patient-controlled postoperative analgesia and ibuprofen', 'VATS', 'ultrasound (US)-guided erector spinae plane block (ESPB) and serratus anterior plane block (SAPB']","['VAS scores and opioid consumption', 'Static/dynamic VAS scores', 'Intraoperative and postoperative opioid consumption', 'perioperative and postoperative (48 hours) opioid consumption', 'Visual analog scale (VAS) scores, opioid consumption, and adverse events', 'rescue analgesic use', 'Block procedure time and one-time puncture success', 'adverse effects', 'static VAS scores']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",60.0,0.139796,Static/dynamic VAS scores were significantly lower in the ESPB group (P < 0.05).,"[{'ForeName': 'Mürsel', 'Initials': 'M', 'LastName': 'Ekinci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, School of Medicine, Mega Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Bahadir', 'Initials': 'B', 'LastName': 'Ciftci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, School of Medicine, Mega Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Birzat Emre', 'Initials': 'BE', 'LastName': 'Gölboyu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Manisa State Hospital, Manisa, Turkey.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Demiraran', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, School of Medicine, Mega Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Bayrak', 'Affiliation': 'Department of Thoracic Surgery, Istanbul Medipol University, Mega Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Tulgar', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Maltepe University, Istanbul, Turkey.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa101']
2211,32417946,Impact of a short-term synbiotic supplementation on metabolic syndrome and systemic inflammation in elderly patients: a randomized placebo-controlled clinical trial.,"PURPOSE


The connection between gut microbiota imbalance, inflammation and its role in the pathogenesis of metabolic syndrome (MetS) clustering factors has been increasingly recognized. However, data on the efficacy of probiotics supplementation on MetS components are few and almost lacking in the elderly. To address this issue, we conducted a randomized, double-blind, placebo-controlled, parallel-group, clinical study on a large sample of MetS elderly patients.
METHODS


After 14 days of diet and physical activity standardization, 60 elderly patients were randomized to treatment with a synbiotic formula of Lactobacillus plantarum PBS067, Lactobacillus acidophilus PBS066 and Lactobacillus reuteri PBS072 with active prebiotics or placebo. Patients were evaluated anamnestically and by the execution of a physical examination and laboratory and haemodynamic analyses at the baseline and after 60 days of treatment. At enrollment and at the end of the trial, all enrolled patients complete the EuroQol-5 Dimension (EQ-5D) questionnaire.
RESULTS


Through the 2-month period of treatment, patients who received active treatment experienced a statistically significant improvement in waist circumference and in fasting plasma insulin, total cholesterol, high-density lipoprotein cholesterol, non-HDL-C, triglycerides (TG), low-density lipoprotein cholesterol, high-sensitivity C-reactive protein and tumor necrosis factor alpha serum levels, compared both to the baseline and the control group. Visceral adiposity index improvement in the synbiotic treatment group was significantly greater than in placebo group. Compared to baseline, treatment with synbiotics also significantly reduced mean arterial pressure and fasting plasma glucose. All treatment groups demonstrated a significant decrease in TG. TG reduction in the synbiotic group was significantly greater than in the control group. The EQ-5D VAS questionnaire significantly improved only in probiotics-treated subjects.
CONCLUSION


Treatment with a synbiotic formula of L. plantarum PBS067, L. acidophilus PBS066 and L. reuteri PBS072 with active prebiotics decreased MetS syndrome prevalence, several cardiovascular risk factors and markers of insulin resistance in elderly patients.",2020,", patients who received active treatment experienced a statistically significant improvement in waist circumference and in fasting plasma insulin, total cholesterol, high-density lipoprotein cholesterol, non-HDL-C, triglycerides (TG), low-density lipoprotein cholesterol, high-sensitivity C-reactive protein and tumor necrosis factor alpha serum levels, compared both to the baseline and the control group.","['MetS elderly patients', '60 elderly patients', 'elderly patients']","['probiotics supplementation', 'short-term synbiotic supplementation', 'synbiotic formula of Lactobacillus plantarum PBS067, Lactobacillus acidophilus PBS066 and Lactobacillus reuteri PBS072 with active prebiotics or placebo', 'placebo']","['mean arterial pressure and fasting plasma glucose', 'Visceral adiposity index improvement', 'EuroQol-5 Dimension (EQ-5D) questionnaire', 'TG reduction', 'metabolic syndrome and systemic inflammation', 'TG', 'EQ-5D VAS questionnaire', 'waist circumference and in fasting plasma insulin, total cholesterol, high-density lipoprotein cholesterol, non-HDL-C, triglycerides (TG), low-density lipoprotein cholesterol, high-sensitivity C-reactive protein and tumor necrosis factor alpha serum levels']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.147287,", patients who received active treatment experienced a statistically significant improvement in waist circumference and in fasting plasma insulin, total cholesterol, high-density lipoprotein cholesterol, non-HDL-C, triglycerides (TG), low-density lipoprotein cholesterol, high-sensitivity C-reactive protein and tumor necrosis factor alpha serum levels, compared both to the baseline and the control group.","[{'ForeName': 'Arrigo F G', 'Initials': 'AFG', 'LastName': 'Cicero', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum, Università di Bologna, Bologna, Italy. arrigo.cicero@unibo.it.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Fogacci', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Marilisa', 'Initials': 'M', 'LastName': 'Bove', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Giovannini', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Borghi', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum, Università di Bologna, Bologna, Italy.'}]",European journal of nutrition,['10.1007/s00394-020-02271-8']
2212,32421187,"A quality-improvement optimization pilot of BariFit, a mobile health intervention to promote physical activity after bariatric surgery.","Bariatric surgery is the most effective treatment for severe obesity (body mass index >40), helping individuals lose, on average, 25%-29% of their body weight over the first year. However, many patients begin to plateau and regain weight within 12-24 months, and 20% of patients begin to regain weight within 6 months postsurgery. As physical activity (PA) is an important predictor of weight loss and maintenance postsurgery, there is a need for scalable, effective lifestyle interventions to help bariatric patients increase PA in order to maximize their weight loss and maintenance. To assess feasibility of using mobile health (mHealth) tools to support PA postsurgery, we conducted a quality-improvement optimization pilot of BariFit, an mHealth intervention that combines commercial devices and custom text messages. Fifty-one bariatric patients enrolled in a 16-week optimization pilot of BariFit. To assess feasibility, pre-post changes in PA were assessed using activPAL. In addition, the pilot randomized, using a 2 × 2 factorial design, two adaptive approaches to daily step goals (variable and 60th percentile goals) and provision of rest days (yes/no), and microrandomized provision of SMS-delivered activity suggestions five times a day for each participant. Adherence to using study equipment was over 95% at 16 weeks. Participants increased PA by 1,866 steps from baseline to end-of-study (p < .007). Participants who received variable step goals averaged 1,141 more steps per day (p = .096) than those who received 60th percentile goals. Activity suggestions had no effect. mHealth interventions are feasible for supporting PA postbariatric surgery.",2020,"Participants who received variable step goals averaged 1,141 more steps per day (p = .096) than those who received 60th percentile goals.",['Fifty-one bariatric patients enrolled in a 16-week optimization pilot of BariFit'],"['BariFit, a mobile health intervention', 'mobile health (mHealth', 'Bariatric surgery']",[],"[{'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]",[],51.0,0.0300114,"Participants who received variable step goals averaged 1,141 more steps per day (p = .096) than those who received 60th percentile goals.","[{'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Klasnja', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle WA, USA.'}, {'ForeName': 'Dori E', 'Initials': 'DE', 'LastName': 'Rosenberg', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle WA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle WA, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Anau', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle WA, USA.'}, {'ForeName': 'Anirban', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Bariatric Surgery Program, Kaiser Permanente Bellevue, Seattle, WA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Arterburn', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle WA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibaa040']
2213,31813450,Metronomic Maintenance Therapy for Rhabdomyosarcoma.,"In a recent article, Bisogno et al. reported in a randomized trial that addition of metronomic maintenance therapy (MMT) with vinorelbine plus cyclophosphamide for children with rhabdomyosarcoma resulted in a significant increase in overall and event-free survival. Although the mechanism of action remains to be fully elucidated, this study paves the way for further evaluation of MMT as a potential therapeutic strategy in pediatric patients with high-risk disease.",2019,reported in a randomized trial that addition of metronomic maintenance therapy (MMT) with vinorelbine plus cyclophosphamide for children with rhabdomyosarcoma resulted in a significant increase in overall and event-free survival.,"['children with rhabdomyosarcoma', 'Rhabdomyosarcoma', 'pediatric patients with high-risk disease']","['metronomic maintenance therapy (MMT) with vinorelbine plus cyclophosphamide', 'Metronomic Maintenance Therapy']",['overall and event-free survival'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",,0.0369751,reported in a randomized trial that addition of metronomic maintenance therapy (MMT) with vinorelbine plus cyclophosphamide for children with rhabdomyosarcoma resulted in a significant increase in overall and event-free survival.,"[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'André', 'Affiliation': ""Pediatric Hematology and Oncology Department, Hôpital pour Enfant de La Timone, Assistance Publique - Hôpitaux de Marseille (AP-HM), Marseille, France; SMARTc unit, Centre de Recherche en Cancérologie de Marseille, Institut National de la Santé et de la Recherche Médicale (INSERM) Unité 1068, Université d'Aix-Marseille, Marseille, France; Metronomics Global Health Initiative, Marseille, France. Electronic address: nicolas.andre@ap-hm.fr.""}, {'ForeName': 'Nadège', 'Initials': 'N', 'LastName': 'Corradini', 'Affiliation': ""Institut d'Hématologie et Oncologie Pédiatrique, Lyon, France.""}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Shaked', 'Affiliation': 'Metronomics Global Health Initiative, Marseille, France; Faculty of Medicine, Cell Biology, and Cancer Science, Technion-Integrated Cancer Center, Technion, Israel Institute of Technology, Haifa, Israel.'}]",Trends in cancer,['10.1016/j.trecan.2019.10.004']
2214,26194850,Nutrient supplementation may adversely affect maternal oral health--a randomised controlled trial in rural Malawi.,"Nutritional supplementation during pregnancy is increasingly recommended especially in low-resource settings, but its oral health impacts have not been studied. Our aim was to examine whether supplementation with multiple micronutrients (MMN) or small-quantity lipid-based nutrient supplements affects dental caries development or periodontal health in a rural Malawian population. The study was embedded in a controlled iLiNS-DYAD trial that enrolled 1391 pregnant women <20 gestation weeks. Women were provided with one daily iron-folic acid capsule (IFA), one capsule with 18 micronutrients (MMN) or one sachet of lipid-based nutrient supplements (LNS) containing protein, carbohydrates, essential fatty acids and 21 micronutrients. Oral examination of 1024 participants was conducted and panoramic X-ray taken within 6 weeks after delivery. The supplement groups were similar at baseline in average socio-economic, nutritional and health status. At the end of the intervention, the prevalence of caries was 56.7%, 69.1% and 63.3% (P = 0.004), and periodontitis 34.9%, 29.8% and 31.2% (P = 0.338) in the IFA, MMN and LNS groups, respectively. Compared with the IFA group, women in the MMN group had 0.60 (0.18-1.02) and in the LNS group 0.59 (0.17-1.01) higher mean number of caries lesions. In the absence of baseline oral health data, firm conclusions on causality cannot be drawn. However, although not confirmatory, the findings are consistent with a possibility that provision of MMN or LNS may have increased the caries incidence in this target population. Because of the potential public health impacts, further research on the association between gestational nutrient interventions and oral health in low-income settings is needed.",2016,"At the end of the intervention, the prevalence of caries was 56.7%, 69.1% and 63.3% (P = 0.004), and periodontitis 34.9%, 29.8% and 31.2% (P = 0.338) in the IFA, MMN and LNS groups, respectively.","['enrolled 1391 pregnant women <20 gestation weeks', 'rural Malawi', '1024 participants', 'affects dental caries development or periodontal health in a rural Malawian population']","['Nutrient supplementation', 'IFA', 'Nutritional supplementation', 'daily iron-folic acid capsule (IFA), one capsule with 18 micronutrients (MMN) or one sachet of lipid-based nutrient supplements (LNS) containing protein, carbohydrates, essential fatty acids and 21 micronutrients', 'MMN', 'supplementation with multiple micronutrients (MMN) or small-quantity lipid-based nutrient supplements']","['average socio-economic, nutritional and health status', 'maternal oral health', 'caries incidence', 'prevalence of caries']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C4319662', 'cui_str': 'Sachet'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0015686', 'cui_str': 'Fatty Acids, Essential'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]","[{'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0029162'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",1391.0,0.154425,"At the end of the intervention, the prevalence of caries was 56.7%, 69.1% and 63.3% (P = 0.004), and periodontitis 34.9%, 29.8% and 31.2% (P = 0.338) in the IFA, MMN and LNS groups, respectively.","[{'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Harjunmaa', 'Affiliation': 'Department of International Health, University of Tampere School of Medicine, Tampere, Finland.'}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Järnstedt', 'Affiliation': 'Department of Radiology, Medical Imaging Center, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, California, USA.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Department of International Health, University of Tampere School of Medicine, Tampere, Finland.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'Department of Community Health, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Vosti', 'Affiliation': 'Department of Agricultural and Resource Economics, University of California Davis, Davis, California, USA.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Department of International Health, University of Tampere School of Medicine, Tampere, Finland.'}]",Maternal & child nutrition,['10.1111/mcn.12204']
2215,32417812,Reducing lumbar spine flexion using real-time biofeedback during patient handling tasks.,"BACKGROUND


Patient handling activities require caregivers to adopt postures that increase the risk of back injury. Training programs relying primarily on didactic methods have been shown to be ineffective in reducing this risk. The use of real-time biofeedback has potential as an alternative training method.
OBJECTIVE


To investigate the effect of real-time biofeedback on time spent by caregivers in end-range lumbar spine flexion.
METHODS


Novice participants were divided into intervention (n = 10) and control (n = 10) groups and asked to perform a set of simulated care activities eight times on two consecutive days. Individuals in the intervention group watched a training video on safer movement strategies and received real-time auditory feedback from a wearable device (PostureCoach) in four training trials whenever their lumbar spine flexion exceeded a threshold (70% of maximum flexion). Changes in end-range lumbar spine flexion were compared between groups and across trials.
RESULTS


Participants in the intervention group saw reductions in end-range lumbar spine flexion during the simulated patient handling tasks at the end of the training compared to their baseline trials while there was no change for the control group.
CONCLUSIONS


The training program including PostureCoach has the potential to help caregivers learn to use safer postures that reduce the risk of back injury.",2020,"RESULTS


Participants in the intervention group saw reductions in end-range lumbar spine flexion during the simulated patient handling tasks at the end of the training compared to their baseline trials while there was no change for the control group.
",['Novice participants'],"['training video on safer movement strategies and received real-time auditory feedback from a wearable device (PostureCoach', 'real-time biofeedback']","['end-range lumbar spine flexion', 'lumbar spine flexion']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]",,0.0415063,"RESULTS


Participants in the intervention group saw reductions in end-range lumbar spine flexion during the simulated patient handling tasks at the end of the training compared to their baseline trials while there was no change for the control group.
","[{'ForeName': 'Mohammadhasan', 'Initials': 'M', 'LastName': 'Owlia', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, ON, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kamachi', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, ON, Canada.'}, {'ForeName': 'Tilak', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, ON, Canada.'}]","Work (Reading, Mass.)",['10.3233/WOR-203149']
2216,32417961,Postoperative morbidity after adenotonsillectomy versus adenopharyngoplasty in young children with obstructive sleep apnea: an RCT.,"PURPOSE


In our previous randomized controlled trial (RCT), comparing adenotonsillectomy (ATE) with adenopharyngoplasty (APP) in children with severe obstructive sleep apnea (OSA), there were no differences in respiratory sleep parameters or quality of life. The purpose of the present report was to evaluate postoperative morbidity from this RCT.
METHODS


The study was a blinded RCT in 83 children (ATE = 47; APP = 36), 2-4 years of age, with an obstructive apnea-hypopnea index of ≥ 10. Pain was assessed from the first until the tenth day after surgery with a logbook that reported pain by child (FPS-R, Faces Pain Scale-Revised) and caregiver (visual analogue scale), analgesic use, return to normal diet, and weight change. Bleeding, infection, satisfaction with treatment, speech, and swallowing were assessed with a questionnaire and medical records 6 months after surgery.
RESULTS


Sixty-four children (77%) returned the logbook and 65 (78%) answered the questionnaire. The median (interquartile range) day the children graded themselves as pain free (FPS-R = 0) was 7 (6-10) after ATE, compared with 9 (7 to > 10) after APP (p = 0.018). There were no other significant differences between the groups regarding any other pain-related outcomes, bleeding, infection, satisfaction, swallowing, or speech, but three children (11%) reported impaired speech after APP compared to none after ATE (p = 0.067).
CONCLUSION


The results regarding postoperative morbidity were in favor of ATE and the results from our previous report showed no advantages of APP. Therefore, APP should not be recommended in young, otherwise healthy children with OSA.",2020,"There were no other significant differences between the groups regarding any other pain-related outcomes, bleeding, infection, satisfaction, swallowing, or speech, but three children (11%) reported impaired speech after APP compared to none after ATE (p = 0.067).
","['83 children (ATE\u2009=\u200947; APP\u2009=\u200936), 2-4\xa0years of age, with an obstructive apnea-hypopnea index of\u2009≥\u200910', 'healthy children with OSA', 'young children with obstructive sleep apnea', 'children with severe obstructive sleep apnea (OSA']","['adenotonsillectomy versus adenopharyngoplasty', 'adenotonsillectomy (ATE) with adenopharyngoplasty (APP']","['respiratory sleep parameters or quality of life', 'Pain', 'pain free', 'postoperative morbidity', 'pain-related outcomes, bleeding, infection, satisfaction, swallowing, or speech', 'Postoperative morbidity', 'impaired speech after APP', 'pain by child (FPS-R, Faces Pain Scale-Revised) and caregiver (visual analogue scale), analgesic use, return to normal diet, and weight change', 'Bleeding, infection, satisfaction with treatment, speech, and swallowing']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0233715', 'cui_str': 'Disturbance in speech'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2676780', 'cui_str': 'Progeroid Syndrome, Congenital, Petty Type'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",83.0,0.0413008,"There were no other significant differences between the groups regarding any other pain-related outcomes, bleeding, infection, satisfaction, swallowing, or speech, but three children (11%) reported impaired speech after APP compared to none after ATE (p = 0.067).
","[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Fehrm', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden. johan.fehrm@sll.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Borgström', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nerfeldt', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Friberg', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06035-2']
2217,32424253,Closed-loop digital meditation for neurocognitive and behavioral development in adolescents with childhood neglect.,"Adverse childhood experiences are linked to poor attentive behaviors during adolescence, as well as increased risk for mental health disorders in adults. However, no study has yet tested targeted interventions to optimize neurocognitive processes in this population. Here, we investigated closed-loop digital interventions in a double-blind randomized controlled study in adolescents with childhood neglect, and evaluated the outcomes using multimodal assessments of neuroimaging, cognitive, behavioral, and academic evaluations. In the primary neuroimaging results, we demonstrate that a closed-loop digital meditation intervention can strengthen functional connectivity of the dorsal anterior cingulate cortex (dACC) in the cingulo-opercular network, which is critically developing during the adolescent period. Second, this intervention enhanced sustained attention and interference-resolution abilities, and also reduced behavioral hyperactivity at a 1-year follow-up. Superior academic performance was additionally observed in adolescents who underwent the digital meditation intervention. Finally, changes in dACC functional connectivity significantly correlated with improvements in sustained attention, hyperactivity, and academic performance. This first study demonstrates that closed-loop digital meditation practice can facilitate development of important aspects of neurocognition and real-life behaviors in adolescents with early childhood neglect.",2020,This first study demonstrates that closed-loop digital meditation practice can facilitate development of important aspects of neurocognition and real-life behaviors in adolescents with early childhood neglect.,"['mental health disorders in adults', 'adolescents with early childhood neglect', 'adolescents with childhood neglect']","['closed-loop digital interventions', 'closed-loop digital meditation intervention', 'digital meditation intervention', 'Closed-loop digital meditation']","['dACC functional connectivity', 'Superior academic performance', 'sustained attention, hyperactivity, and academic performance', 'behavioral hyperactivity', 'sustained attention and interference-resolution abilities']","[{'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0298422,This first study demonstrates that closed-loop digital meditation practice can facilitate development of important aspects of neurocognition and real-life behaviors in adolescents with early childhood neglect.,"[{'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Mishra', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA. jymishra@ucsd.edu.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Sagar', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Parveen', 'Affiliation': 'Department of Pediatric Neurology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Kumaran', 'Affiliation': 'Department of Nuclear Magnetic Resonance, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Modi', 'Affiliation': 'Udayan Care, New Delhi, India.'}, {'ForeName': 'Vojislav', 'Initials': 'V', 'LastName': 'Maric', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ziegler', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gazzaley', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}]",Translational psychiatry,['10.1038/s41398-020-0820-z']
2218,32416926,[Effect of activities profile variations on health-related quality of life among breast cancer patients: Secondary exploratory analysis from PASAPAS study data].,"INTRODUCTION


Lifestyle changes in breast cancer patients, by physical activity increasing, are becoming a main objective in supportive care. The objective of this study was to explore the impact of the daily activity profile evolution on the quality of life among this public.
METHODS


Sixty patients (18 to 75 years) with non-metastatic breast cancer were randomized to a 2:1 ratio (physical activity intervention; control) in the PASAPAS randomized clinical trial. Multiple linear regression analyzes were computed to explain quality of life scores 6 months after the start of adjuvant therapy. Variables retained were the baseline quality of life scores, the anxiety trait, the randomization arm, the variations of time spent in different physical activity classes ([3-4 [MET, [4-6 [MET, ≥6 MET) and in sedentary behaviors.
RESULTS


Only the decrease in time spent in sedentary behaviors really appeared as a predictor of the quality of physical life. Participation in the intervention group appeared as a predictor of quality of mental life.
DISCUSSION


Results plead in favor of sedentary life style decrease as part of the objectives of care program for women with breast cancer. It also highlights the need of collective supervised sessions implemented by competent staff. This research also suggests that the dynamics of daily activity profile variations should be studied further in association to quality of life.",2020,"Participation in the intervention group appeared as a predictor of quality of mental life.
","['breast cancer patients', 'Sixty patients (18 to 75 years) with non-metastatic breast cancer', 'women with breast cancer']","['2:1 ratio (physical activity intervention; control', 'activities profile variations']","['quality of mental life', 'quality of physical life', 'baseline quality of life scores, the anxiety trait, the randomization arm, the variations of time spent in different physical activity classes', 'health-related quality of life', 'time spent in sedentary behaviors']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}]",,0.041616,"Participation in the intervention group appeared as a predictor of quality of mental life.
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Reynes', 'Affiliation': ""Université Lyon, université Claude-Bernard Lyon 1, laboratoire sur les vulnérabilités et l'innovation dans le sport (L-ViS, EA 7428), 69622 Lyon, France; UFR STAPS, 27-29, boulevard du 11 Novembre 1918, 69622 Villeurbanne cedex, France. Electronic address: eric.reynes@univ-lyon1.fr.""}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Berthouze', 'Affiliation': 'Université Lyon, université Claude-Bernard Lyon 1, laboratoire interuniversitaire de biologie de la motricité (LIBM, EA 7424), 69622 Lyon, France; UFR STAPS, 27-29, boulevard du 11 Novembre 1918, 69622 Villeurbanne cedex, France.'}, {'ForeName': 'Aude-Marie', 'Initials': 'AM', 'LastName': 'Foucaut', 'Affiliation': 'Université Sorbonne Paris Nord, laboratoire éducations et pratiques de santé (LEPS, UR 3412), Département STAPS, 74, rue Marcel-Cachin, 93017 Bobigny, France; Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Morelle', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France; Université de Lyon, GATE Lyon Saint-Étienne, UMR-CNRS 5824, 69007 Lyon, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Bachmann', 'Affiliation': 'Centre Léon Bérard, unité de nutrition et diététique\xa0-\xa0DISSPO, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Kempf-Lépine', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France; Centre Léon Bérard, département cancer environnement, laboratoire «\xa0Santé, Individu, Société\xa0» EAM 4128, faculté de médecine Laënnec, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Meyrand', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Baudinet', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Carretier', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, laboratoire «\xa0Santé, Individu, Société\xa0» EAM 4128, faculté de médecine Laënnec, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Trédan', 'Affiliation': ""Centre Léon Bérard, département d'oncologie médicale, 28, rue Laennec, 69008 Lyon, France.""}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Fervers', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France; Centre de recherche en cancérologie de Lyon, UMR, Inserm 1052, CNRS 5286 CLB, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Touillaud', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France; Centre de recherche en cancérologie de Lyon, UMR, Inserm 1052, CNRS 5286 CLB, 28, rue Laennec, 69008 Lyon, France.'}]",Bulletin du cancer,['10.1016/j.bulcan.2020.03.014']
2219,32417819,The effects of background music tempo on the work attention performance of workers with schizophrenia.,"BACKGROUND


Work attention in employees with schizophrenia is a significant issue in vocational rehabilitation. Background music is very popular in workplaces, and according to some investigations, can help increase attention at work if utilized appropriately.
OBJECTIVE


This study investigates the influence of background music tempo on attention performance in employees with chronic schizophrenia.
METHODS


A randomized controlled trial (RCT) study was performed to test the attention of 240 participants with chronic schizophrenia under four conditions, namely no music, fast tempo, slow tempo and white noise.
RESULTS


Employees with schizophrenia achieved higher attention scores under background music than in a no-music environment. Additionally, slow-tempo music produced higher attention scores than fast-tempo music.
CONCLUSIONS


Observational results indicate that slow-tempo background music is more desirable than fast-tempo background music in a work environment involving schizophrenic individuals.",2020,"RESULTS


Employees with schizophrenia achieved higher attention scores under background music than in a no-music environment.","['240 participants with chronic schizophrenia under four conditions, namely no music, fast tempo, slow tempo and white noise', 'workers with schizophrenia', 'employees with chronic schizophrenia', 'Employees with schizophrenia', 'employees with schizophrenia']","['background music tempo', 'slow-tempo music']","['attention performance', 'higher attention scores', 'attention scores']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0439834', 'cui_str': 'Slow'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",240.0,0.211361,"RESULTS


Employees with schizophrenia achieved higher attention scores under background music than in a no-music environment.","[{'ForeName': 'Yi-Nuo', 'Initials': 'YN', 'LastName': 'Shih', 'Affiliation': 'Department of Occupational Therapy, College of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan.'}, {'ForeName': 'Kuo-Hsin', 'Initials': 'KH', 'LastName': 'Chu', 'Affiliation': 'Taipei Veterans General Hospital Yuli Branch, Tapei, Taiwan.'}, {'ForeName': 'Chia-Chun', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'Department of Occupational Therapy, College of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan.'}]","Work (Reading, Mass.)",['10.3233/WOR-203156']
2220,32417952,"The INFluence of Remote monitoring on Anxiety/depRession, quality of lifE, and Device acceptance in ICD patients: a prospective, randomized, controlled, single-center trial.","BACKGROUND


Impact of telemedicine with remote patient monitoring (RPM) in implantable cardioverter-defibrillator (ICD) patients on clinical outcomes has been investigated in various clinical settings with divergent results. However, role of RPM on patient-reported-outcomes (PRO) is unclear. The INFRARED-ICD trial aimed to investigate the effect of RPM in addition to standard-of-care on PRO in a mixed ICD patient cohort.
METHODS AND RESULTS


Patients were randomized to RPM (n = 92) or standard in-office-FU (n = 88) serving as control group (CTL). At baseline and on a monthly basis over 1 year, study participants completed the EQ-5D questionnaire for the primary outcome Quality of Life (QoL), the Hospital Anxiety and Depression Scale, and the Florida Patient Acceptance Survey questionnaire for secondary outcomes. Demographic characteristics (82% men, mean age 62.3 years) and PRO at baseline were not different between RPM and CTL. Primary outcome analysis showed that additional RPM was not superior to CTL with respect to QoL over 12 months [+ 1.2 vs. + 3.9 points in CTL and RPM group, respectively (p = 0.24)]. Pre-specified analyses could not identify subgroups with improved QoL by the use of RPM. Neither levels of anxiety (- 0.4 vs. - 0.3, p = 0.88), depression (+ 0.3 vs. ± 0.0, p = 0.38), nor device acceptance (+ 1.1 vs. + 1.6, p = 0.20) were influenced by additional use of RPM.
CONCLUSION


The results of the present study show that PRO were not improved by RPM in addition to standard-of-care FU. Careful evaluation and planning of future trials in selected ICD patients are warranted before implementing RPM in routine practice.",2020,"Neither levels of anxiety (- 0.4 vs. - 0.3, p = 0.88), depression (+ 0.3 vs. ± 0.0, p = 0.38), nor device acceptance (+ 1.1 vs. + 1.6, p = 0.20) were influenced by additional use of RPM.
","['Patients were randomized to RPM (n\u2009=\u200992) or', 'ICD patients', 'selected ICD patients']","['RPM', 'implantable cardioverter-defibrillator (ICD', 'standard in-office-FU (n\u2009=\u200988) serving as control group (CTL', 'telemedicine with remote patient monitoring (RPM']","['Anxiety/depRession, quality of lifE, and Device acceptance', 'EQ-5D questionnaire for the primary outcome Quality of Life (QoL), the Hospital Anxiety and Depression Scale, and the Florida Patient Acceptance Survey questionnaire for secondary outcomes', 'device acceptance', 'Demographic characteristics', 'additional RPM was not superior to CTL with respect to QoL', 'depression', 'levels of anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",,0.135883,"Neither levels of anxiety (- 0.4 vs. - 0.3, p = 0.88), depression (+ 0.3 vs. ± 0.0, p = 0.38), nor device acceptance (+ 1.1 vs. + 1.6, p = 0.20) were influenced by additional use of RPM.
","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Leppert', 'Affiliation': 'School of Public Health, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Siebermair', 'Affiliation': 'Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Wesemann', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychotraumatology, Bundeswehr Hospital, Berlin, Germany.'}, {'ForeName': 'Eimo', 'Initials': 'E', 'LastName': 'Martens', 'Affiliation': 'Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.'}, {'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Sattler', 'Affiliation': 'Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Scholz', 'Affiliation': 'School of Public Health, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Veith', 'Affiliation': 'Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Greiner', 'Affiliation': 'School of Public Health, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Tienush', 'Initials': 'T', 'LastName': 'Rassaf', 'Affiliation': 'Department of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, University of Essen Medical School, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kääb', 'Affiliation': 'Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Wakili', 'Affiliation': 'Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany. reza.wakili@uk-essen.de.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01667-0']
2221,32418011,Multi-modular bone healing assessment in a randomized controlled clinical trial of root-end surgery with the use of leukocyte- and platelet-rich fibrin and an occlusive membrane.,"OBJECTIVES


The aim of this study was to assess in a multi-modular manner the bone healing 1 year post root-end surgery (RES) with leukocyte- and platelet-rich fibrin (LPRF) and Bio-Gide® (BG; Geistlich Pharma North America, Inc., Princeton, USA) as an occlusive membrane.
MATERIALS AND METHODS


A randomized controlled clinical trial (RCT) of RES +/- LPRF and +/- BG was performed. The follow-up until 1 year post RES was performed by means of ultrasound imaging (UI), periapical radiographs (PR), and cone-beam computed tomography (CBCT).
RESULTS


From the 50 included patients, 6 dropped-out during follow-up. For the 44 assessed patients (34 with UI and 42 with PR and CBCT), there was no evidence (p > 0.05) for an effect of LRPF, neither on UI measurements nor on CBCT assessments. On the contrary, there was an indication for a better outcome with BG. UI presented significant shorter healing time for the bony crypt surface (p = 0.014) and cortical opening (p = 0.006) for the groups with BG. The qualitative CBCT assessment for the combined scores of the apical area and cortical plane was significantly higher for BG (p = 0.01 and 0.02). The quantitative CBCT measurement for bone healing after 1 year was lower with BG (p = 0.019), as well as the percentage of non-zero values (p = 0.026), irrespective of the preoperative lesion size and type. Furthermore, UI seemed to be safer for frequent follow-up during the early postoperative stage (0-3 months), whereas CBCT gave more accurate results 1 year post RES. Amongst the assessors, the qualitative PR analysis was inconsistent for a favorable outcome 1 year post RES with LPRF (p = 0.11 and p = 0.023), but consistent for BG (p = 0.024 and p = 0.023).
CONCLUSIONS


There was no evidence for improvement of bone healing when RES was applied with LPRF in comparison with RES without LPRF. However, RES with BG gave evidence for a better outcome than RES without BG.
CLINICAL RELEVANCE


The addition of an occlusive membrane rather than an autologous platelet concentrate improved bone regeneration 1 year post RES significantly, irrespective of the assessment device applied. The accuracy of PR assessment is questionable.",2020,There was no evidence for improvement of bone healing when RES was applied with LPRF in comparison with RES without LPRF.,[],"['bone healing 1\xa0year post root-end surgery (RES) with leukocyte- and platelet-rich fibrin (LPRF) and Bio-Gide® (BG', 'RES ', 'Multi-modular bone healing assessment', 'leukocyte- and platelet-rich fibrin', 'LPRF and ']","['healing time', 'bone healing', 'quantitative CBCT measurement for bone healing', 'cortical opening', 'bone regeneration 1']",[],"[{'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0539912', 'cui_str': 'Bio-Gide'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}]",50.0,0.0871603,There was no evidence for improvement of bone healing when RES was applied with LPRF in comparison with RES without LPRF.,"[{'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Meschi', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium. nastaran.meschi@kuleuven.be.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Vanhoenacker', 'Affiliation': 'Stomatology and Maxillofacial Surgery, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Strijbos', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Camargo Dos Santos', 'Affiliation': 'Department of Oral Health Sciences, BIOMAT - Biomaterials Research Group, Dentistry, KU Leuven (University of Leuven), Kapucijnenvoer 7 Blok a, Box 7001, 3000, Leuven, Belgium.'}, {'ForeName': 'Eléonore', 'Initials': 'E', 'LastName': 'Rubbers', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Peeters', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Curvers', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Van Mierlo', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Geukens', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Fieuws', 'Affiliation': 'Biostatistics and Statistical Bioinformatics Centre, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Verbeken', 'Affiliation': 'Translational Cell & Tissue Research, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lambrechts', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}]",Clinical oral investigations,['10.1007/s00784-020-03309-1']
2222,32418142,Dual Antiplatelet Therapy Duration in Medically Managed Acute Coronary Syndrome Patients: Sub-Analysis of the OPT-CAD Study.,"INTRODUCTION


Optimal dual antiplatelet therapy (DAPT) duration for medically managed acute coronary syndrome (ACS) (MMACS) patients is still unknown. We explored the efficacy and safety of ≥ 12-month DAPT among MMACS patients.
METHODS


In this sub-analysis of the optimal antiplatelet therapy for Chinese Patients with Coronary Artery Disease study (NCT01735305), clinical outcomes among MMACS patients were compared between the < 12-month and ≥ 12-month DAPT groups. The primary efficacy endpoint was a composite of cardiac death, myocardial infarction, and stroke. Safety endpoints included the Bleeding Academic Research Consortium (BARC) 2-5, BARC 3-5, and all bleeding events. Propensity score matching (PSM) was used to compare baseline characteristics between the < 12-month and ≥ 12-month DAPT groups.
RESULTS


In this cohort of ACS patients (n = 10,016), MMACS patients (n = 2967) were less likely to use DAPT at 12 (31.64% vs. 67.47%, P < 0.0001) and 24 (13.82% vs. 18.71%, P < 0.0001) months and experienced more ischemic events at 12 (4.55% vs. 3.40%, P = 0.006) and 24 (6.88% vs. 5.08%, P = 0.0004) months than those treated with percutaneous coronary intervention (n = 7049). Among MMACS patients, the rate of primary efficacy endpoint occurring within the second year was significantly higher in the < 12-month DAPT group than in the ≥ 12-month group both before (2.88% vs. 1.60%, P = 0.040) and after (3.19% vs. 1.71%, P = 0.045) PSM. After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups.
CONCLUSION


MMACS patients with insufficient DAPT management experienced relatively more ischemic events. DAPT for at least 1 year may be beneficial to this special population without significantly increasing the bleeding risks.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT01735305.",2020,"After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups.
","['Medically Managed Acute Coronary Syndrome Patients', 'Chinese Patients with Coronary Artery Disease', 'medically managed acute coronary syndrome (ACS) (MMACS) patients']","['DAPT', 'antiplatelet therapy (DAPT) duration', 'percutaneous coronary intervention', 'MMACS']","['rate of primary efficacy endpoint', 'Bleeding Academic Research Consortium (BARC) 2-5, BARC 3-5, and all bleeding events', 'Propensity score matching (PSM', 'bleeding risks', 'ischemic events', 'all bleeding, BARC 2-5, and BARC 3-5 bleeding', 'efficacy and safety of\u2009≥', 'composite of cardiac death, myocardial infarction, and stroke']","[{'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0365972,"After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups.
","[{'ForeName': 'Sicong', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Zaixin', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Miaohan', 'Initials': 'M', 'LastName': 'Qiu', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China. han1320288258@qq.com.'}]",Advances in therapy,['10.1007/s12325-020-01376-0']
2223,32420973,"Lertal®, a multicomponent nutraceutical, could reduce the use of antihistamines in children with allergic rhinoconjunctivitis.","Antihistamines are the cornerstone treatment of allergic rhinitis (AR). To quantify the antihistaminic consume is particularly relevant in clinical practice, since a remarkable use is usually associated with severe symptoms. The aim of the study was to measure the use of antihistamines in two groups of children suffering from AR. The first group took a course of a nutraceutical (Lertal®) before the observation (active group, AG); a second one was considered as control (control group, CG). Both groups took antihistamines on demand. The children were visited at baseline and after 1 year. The number of days of antihistaminic use was the primary outcome. Children in AG had a significant reduced number of antihistamines use in comparison with CG (p=0.008). In conclusion, the current study showed that a course with a multicomponent nutraceutical could reduce the use of symptomatic antihistamines in children with allergic rhinoconjuncti- vitis.",2020,Children in AG had a significant reduced number of antihistamines use in comparison with CG (p=0.008).,"['children with allergic rhinoconjunctivitis', 'children suffering from AR', 'children with allergic rhinoconjuncti- vitis']","['nutraceutical (Lertal®) before the observation (active group, AG); a second one was considered as control (control group, CG', 'antihistamines', 'Antihistamines']",['number of antihistamines'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}]","[{'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]",,0.0282658,Children in AG had a significant reduced number of antihistamines use in comparison with CG (p=0.008).,"[{'ForeName': 'Maria Angela', 'Initials': 'MA', 'LastName': 'Tosca', 'Affiliation': 'Allergy Center, Istituto Giannina Gaslini, Genoa, Italy. gio.cip@libero.it.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Olcese', 'Affiliation': 'Allergy Center, Istituto Giannina Gaslini, Genoa, Italy. gio.cip@libero.it.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Marinelli', 'Affiliation': 'Allergy Center, Istituto Giannina Gaslini, Genoa, Italy. gio.cip@libero.it.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Papale', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy University . gio.cip@libero.it.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Zicari', 'Affiliation': 'Pediatrics Department, Umberto I Hospital, Roma, Sapienza University , Roma, Italy. gio.cip@libero.it.'}, {'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Marseglia', 'Affiliation': 'Department of Pediatrics, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy. gio.cip@libero.it.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Ciprandi', 'Affiliation': 'Allergy Clinic, Villa Montallegro, Genoa, Italy. gio.cip@libero.it.'}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v91i2.9719']
2224,32421163,The Effects of Aerobic Exercise on Psychological Functioning in Family Caregivers: Secondary Analyses of a Randomized Controlled Trial.,"BACKGROUND


The responsibility and stress of being a family caregiver are associated with reduced physical and mental health.
PURPOSE


To examine whether a 24-week aerobic exercise program improves multiple aspects of psychological functioning in family caregivers.
METHODS


Family caregivers of patients with Alzheimer's disease and other dementias (n = 68) were recruited and randomized into either an aerobic exercise group (n = 34) or a waitlist control group (n = 34). The exercise group was assigned a 24-week aerobic training program that incrementally increased the intensity, duration, and frequency of the exercise program until 150 min of moderate to vigorous activity were completed per week by the ninth week. Twelve measures of psychological functioning were administered at baseline and compared with responses completed following the intervention.
RESULTS


Multilevel modeling revealed significant decreases in caregiver burden (β = -4.60, 95% confidence interval [CI] = [-8.82, -0.38], RLMM2 = 0.11) and depression (β = -2.59, 95% CI = [-4.79, -0.38], RLMM2 = 0.13), as well as increases in mastery (β = 1.78, 95% CI = [0.09, 3.46], RLMM2 = .04) in the exercise intervention group compared to the control group.
CONCLUSION


Family caregivers report high levels of depression and caregiver burden. Engagement in a 24-week exercise intervention can ameliorate the perceived burden of caregiving, symptoms of depression, and their sense of mastery.",2020,"Multilevel modeling revealed significant decreases in caregiver burden (β = -4.60, 95% confidence interval [CI] =","['family caregivers', ""Family caregivers of patients with Alzheimer's disease and other dementias (n = 68"", 'Family Caregivers']","['aerobic exercise program', 'exercise intervention', 'Aerobic Exercise', 'waitlist control group', 'aerobic training program', 'aerobic exercise']","['caregiver burden', 'psychological functioning', 'RLMM2 = 0.11) and depression', 'perceived burden of caregiving, symptoms of depression, and their sense of mastery', 'Psychological Functioning']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C4517425', 'cui_str': '0.11'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",68.0,0.0947633,"Multilevel modeling revealed significant decreases in caregiver burden (β = -4.60, 95% confidence interval [CI] =","[{'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Hives', 'Affiliation': 'School of Kinesiology, University of British Columbia, University Boulevard, Vancouver, BC, Canada.'}, {'ForeName': 'E Jean', 'Initials': 'EJ', 'LastName': 'Buckler', 'Affiliation': 'School of Kinesiology, University of British Columbia, University Boulevard, Vancouver, BC, Canada.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Weiss', 'Affiliation': 'Population Studies Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Schilf', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Johansen', 'Affiliation': 'Department of Medicine, Hennepin County Medical Center and University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Puterman', 'Affiliation': 'School of Kinesiology, University of British Columbia, University Boulevard, Vancouver, BC, Canada.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa031']
2225,32416996,"Restricted versus liberal intraoperative benzodiazepine use in cardiac anaesthesia for reducing delirium (B-Free Pilot): a pilot, multicentre, randomised, cluster crossover trial.","BACKGROUND


Delirium is common after cardiac surgery and is associated with adverse outcomes. Perioperative benzodiazepine use is associated with delirium and is common during cardiac surgery, which may increase the risk of postoperative delirium. We undertook a pilot study to inform the feasibility of a large randomised cluster crossover trial examining whether an institutional policy of restricted benzodiazepine administration during cardiac surgery (compared with liberal administration) would reduce delirium.
METHODS


We conducted a two-centre, pilot, randomised cluster crossover trial with four 4 week crossover periods. Each centre was randomised to a policy of restricted or liberal use, and then alternated between the two policies during the remaining three periods. Our feasibility outcomes were adherence to each policy (goal ≥80%) and outcome assessment (one delirium assessment per day in the ICU in ≥90% of participants). We also evaluated the incidence of intraoperative awareness in one site using serial Brice questionnaires.
RESULTS


Of 800 patients undergoing cardiac surgery during the trial period, 127/800 (15.9%) had delirium. Of these, 355/389 (91.3%) received benzodiazepines during the liberal benzodiazepine periods and 363/411 (88.3%) did not receive benzodiazepines during the restricted benzodiazepine periods. Amongst the 800 patients, 740 (92.5%) had ≥1 postoperative delirium assessment per day in the ICU. Of 521 patients screened for intraoperative awareness, one patient (0.2%), managed during the restricted benzodiazepine period (but who received benzodiazepine), experienced intraoperative awareness.
CONCLUSIONS


This pilot study demonstrates the feasibility of a large, multicentre, randomised, cluster crossover trial examining whether an institutional policy of restricted vs liberal benzodiazepine use during cardiac surgery will reduce postoperative delirium.
CLINICAL TRIAL REGISTRATION


NCT03053869.",2020,"Of 521 patients screened for intraoperative awareness, one patient (0.2%), managed during the restricted benzodiazepine period (but who received benzodiazepine), experienced intraoperative awareness.
","['521 patients screened for intraoperative awareness, one patient (0.2%), managed during the restricted', '800 patients undergoing cardiac surgery during the trial period, 127/800 (15.9%) had delirium']","['benzodiazepines', 'benzodiazepine', 'liberal intraoperative benzodiazepine']",['postoperative delirium assessment'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0919727', 'cui_str': 'Awareness During Anesthesia'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",800.0,0.304096,"Of 521 patients screened for intraoperative awareness, one patient (0.2%), managed during the restricted benzodiazepine period (but who received benzodiazepine), experienced intraoperative awareness.
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Spence', 'Affiliation': 'Department of Anesthesia, McMaster University, Hamilton, ON, Canada; Department of Critical Care, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada. Electronic address: Jessica.Spence@phri.ca.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Belley-Côté', 'Affiliation': 'Department of Critical Care, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jacobsohn', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, University of Manitoba, Winnipeg, MB, Canada; Department of Critical Care, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Shun Fu', 'Initials': 'SF', 'LastName': 'Lee', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whitlock', 'Affiliation': 'Department of Critical Care, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada; Department of Surgery (Cardiac Surgery), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Shrikant', 'Initials': 'S', 'LastName': 'Bangdiwala', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Syed', 'Affiliation': 'Department of Anesthesia, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Sarkaria', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacIsaac', 'Affiliation': 'School of Medicine, Faculty of Medicine, Royal College of Surgeons, Dublin, Ireland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Lengyel', 'Affiliation': 'Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Long', 'Affiliation': 'Department of Anesthesia, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Um', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'McIntyre', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Morvarid', 'Initials': 'M', 'LastName': 'Kavosh', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Fast', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Arora', 'Affiliation': 'Department of Critical Care, University of Manitoba, Winnipeg, MB, Canada; Department of Surgery (Cardiac Surgery), University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Lamy', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada; Department of Surgery (Cardiac Surgery), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.03.030']
2226,32417382,Randomized open-label trial of intravenous brivaracetam versus lorazepam for acute treatment of increased seizure activity.,"OBJECTIVE


The objective of the present trial was to assess efficacy and safety of intravenous (IV) brivaracetam (BRV) vs. lorazepam (LZP) in patients with epilepsy undergoing evaluation in an epilepsy monitoring unit (EMU) who experienced seizures requiring acute treatment.
METHODS


This was a phase 2, open-label, randomized, active-control, proof-of-concept trial (EP0087; NCT03021018). Patients (18-70 years) admitted to EMU were randomized 1:1:1 to single-dose bolus IV LZP (dose per investigator's practice), IV BRV 100 mg, or IV BRV 200 mg. Trial medication had to be administered within 30 min of qualifying seizure. Primary efficacy outcome was time to next seizure (clinical observation with electroencephalogram [EEG] confirmation) or to rescue medication use within 12 h of trial medication administration. Secondary outcomes included seizure freedom and rescue medication use within 12 h of trial medication administration. Safety and tolerability outcomes included treatment-emergent adverse events (TEAEs).
RESULTS


Overall, 46 patients were randomized, and 45 received trial medication for a qualifying seizure. Patients in the LZP arm had doses from 1 to 4 mg (median: 1 mg). Eleven of 45 patients had a seizure within 12 h of trial medication administration (LZP 5/15 [median time to next seizure: 5.55 h], BRV 100 mg 3/15 [5.97 h], BRV 200 mg 3/15 [3.60 h]). No patients received additional rescue medication to control their qualifying seizure. Most patients were seizure-free over 12 h (LZP 9/15 [60.0%], BRV 100 mg 12/15 [80.0%], BRV 200 mg 12/15 [80.0%]). Rescue medication use within 12 h was numerically higher for LZP (6/15 [40.0%]) vs. BRV 100 mg (1/15 [6.7%]) and vs. BRV 200 mg (2/15 [13.3%]). Treatment-emergent adverse events were reported by 5/16 (31.3%), 6/15 (40.0%), and 3/15 (20.0%) of LZP, BRV 100 mg, and BRV 200 mg patients; one LZP patient had a serious TEAE (seizure cluster). Most common TEAEs (≥10% of patients) were sedation and somnolence with LZP, and dizziness, headache, and nausea with BRV.
SIGNIFICANCE


Intravenous LZP, IV BRV 100 mg, and IV BRV 200 mg showed similar efficacy in controlling acute seizure activity in the EMU. Treatment-emergent adverse events were as expected for each medication. Although this trial should be interpreted with caution because of small patient numbers, it suggests a possible role of BRV in the acute treatment of increased seizure activity.",2020,Rescue medication use within 12 h was numerically higher for LZP (6/15 [40.0%]),"['patients with epilepsy undergoing evaluation in an epilepsy monitoring unit (EMU) who experienced seizures requiring acute treatment', 'Patients (18-70\u202fyears) admitted to EMU', 'Eleven of 45 patients had a seizure within 12\u202fh of trial medication administration ', '46 patients']","['intravenous brivaracetam versus lorazepam', 'intravenous (IV) brivaracetam (BRV) vs. lorazepam (LZP', 'single-dose bolus IV LZP', 'LZP']","['time to next seizure (clinical observation with electroencephalogram [EEG] confirmation) or to rescue medication use within 12\u202fh of trial medication administration', 'acute seizure activity', 'sedation and somnolence with LZP, and dizziness, headache, and nausea with BRV', 'seizure activity', 'seizure-free', 'Safety and tolerability outcomes included treatment-emergent adverse events (TEAEs', 'Treatment-emergent adverse events', 'efficacy and safety', 'seizure freedom and rescue medication use within 12\u202fh of trial medication administration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}]",46.0,0.224115,Rescue medication use within 12 h was numerically higher for LZP (6/15 [40.0%]),"[{'ForeName': 'Jerzy P', 'Initials': 'JP', 'LastName': 'Szaflarski', 'Affiliation': 'University of Alabama at Birmingham, Department of Neurology and the UAB Epilepsy Center, 1719 6th Avenue South, CIRC 312, Birmingham, AL 35294, USA. Electronic address: jszaflarski@uabmc.edu.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Sadek', 'Affiliation': 'Neurological Services of Orlando, 3849 Oakwater Cir, Orlando, FL 32806, USA. Electronic address: ahsadek@mac.com.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Greve', 'Affiliation': 'UCB Pharma, Alfred-Nobel-Straße 10, 40789 Monheim am Rhein, Germany. Electronic address: bernhard.greve@ucb.com.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: paulette.williams@ucb.com.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Varner', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: julie.varner@ucb.com.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Moseley', 'Affiliation': 'University of Cincinnati, 260 Stetson Street, Suite 2300, Cincinnati, OH 45267-0525, USA. Electronic address: briandmoseley@gmail.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107127']
2227,32417537,Dual X-ray absorptiometry has limited utility in detecting bone pathology in children with hypophosphatasia: A pooled post hoc analysis of asfotase alfa clinical trial data.,"Asfotase alfa is an enzyme replacement therapy approved for treatment of patients with pediatric-onset hypophosphatasia (HPP), a rare, inherited, systemic disease causing impaired skeletal mineralization, short stature, and reduced physical function in children. The role of dual X-ray absorptiometry (DXA) in the assessment of children with HPP has been insufficiently explored. This post hoc analysis included pooled DXA data from 2 open-label, multicenter studies in 19 children with HPP. The study population was aged ≥5 to <18 years and had received asfotase alfa for ≤6.6 years at enrollment (male: 79%; median age at enrollment: 10.4 y [range: 5.9-16.7];]; treatment duration: 6.3 y [range: 0.1-6.6]. Baseline height Z-scores indicated short stature (median [min, max]: -1.26 [-6.6, 0]; mean [SD]: -2.30 [1.97]), thus requiring height adjustment of DXA Z-scores. At Baseline, few patients had height-adjusted bone mineral density (BMD ht ) Z-scores of -2 or less for whole body (n = 3) or lumbar spine (n = 5). In treated patients, mean whole body and lumbar spine BMD ht Z-scores did not change over time, but whole body and lumbar spine height- adjusted bone mineral content (BMC ht ) Z-scores increased significantly from Baseline to Last Assessment (P ≤ 0.0056). Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht  Z-Scores. Improvements in Rickets Severity Score (RSS) correlated significantly with increases in lumbar spine BMD ht Z-scores and whole body BMC ht  Z-scores (P < 0.05). No significant correlations were observed between any DXA and bone histomorphometry measure. These findings suggest that DXA BMD Z-scores, which are commonly used in clinical practice, have limited utility in assessing deficient bone mineralization in patients with HPP. Although BMC ht  Z-scores increased significantly over time with asfotase alfa therapy, the lack of significant changes in more than one DXA parameter suggests that this tool may not be useful in everyday clinical practice. Furthermore, the use of BMC as an independent metric is not typical or recommended by guidelines. Complementary measures, such as skeletal radiographs supplemented with age-appropriate functional assessments, should be considered.",2020,Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht  Z-Scores.,"['patients with pediatric-onset hypophosphatasia (HPP', 'children with hypophosphatasia', 'The study population was aged ≥5 to <18\u202fyears and had received asfotase alfa for ≤6.6\u202fyears at enrollment (male: 79%; median age at enrollment: 10.4 y [range: 5.9-16.7];]; treatment duration: 6.3 y [range: 0.1-6.6', '19 children with HPP', 'patients with HPP', 'children with HPP']","['dual X-ray absorptiometry (DXA', 'Dual X-ray absorptiometry']","['BMC ht  Z-scores', 'whole body and lumbar spine height- adjusted bone mineral content (BMC ht ) Z-scores', 'mean [SD', 'Rickets Severity Score (RSS', 'mean whole body and lumbar spine BMD ht Z-scores', 'Radiographic Global Impression of Change (RGIC) scale scores', 'DXA and bone histomorphometry measure', 'lumbar spine BMD ht Z-scores and whole body', 'height-adjusted bone mineral density (BMD ht ) Z-scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0020630', 'cui_str': 'Hypophosphatasia'}, {'cui': 'C0520739', 'cui_str': 'Hereditary pyropoikilocytosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517823', 'cui_str': '6.6'}]","[{'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]","[{'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035579', 'cui_str': 'Rickets'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0200771', 'cui_str': 'Bone histomorphometry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",19.0,0.0447297,Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht  Z-Scores.,"[{'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Vanderbilt University, Village at Vanderbilt, 1500 21st Ave South, Suite 1514, Nashville, TN 37212, USA. Electronic address: jill.h.simmons@vumc.org.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Rush', 'Affiliation': ""Department of Pediatrics, Children's Mercy Kansas City, Adele Hall Campus, 2401 Gillham Rd, Kansas City, MO 64108, USA; University of Missouri - Kansas City School of Medicine, 2411 Holmes St, Kansas City, MO 64108, USA; University of Kansas School of Medicine, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: etrush@cmh.edu.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Petryk', 'Affiliation': 'Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210, USA. Electronic address: Anna.Petryk@alexion.com.'}, {'ForeName': 'Shanggen', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Clinical Development Services-Corporate, Covance, Inc., 210 Carnegie Center, Princeton, NJ 08540, USA. Electronic address: shanggen.zhou@covance.com.'}, {'ForeName': 'Gabriel Á', 'Initials': 'GÁ', 'LastName': 'Martos-Moreno', 'Affiliation': 'Department of Endocrinology, Hospital Infantil Universitario Niño Jesús, IIS La Princesa, Av. de Menéndez Pelayo, 65, 28009 Madrid, Spain; Department of Pediatrics, Universidad Autónoma de Madrid, Calle Arzobispo Morcillo, 4, 28029 Madrid, Spain; CIBERobn, Instituto de Salud Carlos III, C/ Sinesio Delgado, 4, 28029 Madrid, Spain. Electronic address: gabrielangelmartos@yahoo.es.'}]",Bone,['10.1016/j.bone.2020.115413']
2228,32418064,Acute assessment of subjective appetite and implicated hormones after a hypnosis-induced hallucinated meal: a randomized cross-over pilot trial.,"The use of hypnosis can generate hallucinatory phenomena, which ranged from vivid/auditory imagery to fully developed ""hallucinations"" in selected people. The aim of this pilot trial was investigating the acute effects of a hypnosis-induced hallucinated breakfast (HB) compared to those of a real breakfast (RB) on subjective appetite and appetite-regulating hormones in highly hypnotizable individuals. Eight healthy post-menopausal women were recruited to consume two meals: the HB and the RB in a randomized crossover design. Participants underwent appetite sensations measurements (before meal and each 30-min until 270-min) and blood sample collection (at 0, 20, 60, 90, 180-min). A 3-day food-record was filled after each meal. The adjusted repeated measures ANCOVA did not show any meal×time interactions on subjective appetite postprandially. As expected, significantly higher glucose (p < 0.001), insulin (p < 0.001), and lower free fatty acid (p < 0.001) concentrations were found after the RB, but not following HB. Furthermore, RB significantly increased postprandial levels of glucagon-like-peptide-1 and peptide-YY at 20, 60, 90 and 180-min, whereas acylated-ghrelin and leptin levels did not differ. Postprandial neuropeptide-Y and orexin-A values significantly increased at different time-points after RB, but not following HB, while α-melanocyte-stimulating hormone levels enhanced after HB only. Energy intakes were significantly lower after HB on the test-day only (HB = 1146.6 ± 343.8 vs RB = 1634.7 ± 274.2 kcal/d; p = 0.003). Appetite sensation might be modulated by fully developed meal ""hallucination"" induced by hypnosis, likely affecting brain-peptides implicated in the appetite regulation. However, further studies are needed to verify these results obtained in a highly selected group of individuals. NCT03934580.",2020,"As expected, significantly higher glucose (p < 0.001), insulin (p < 0.001), and lower free fatty acid (p < 0.001) concentrations were found after the RB, but not following HB.","['highly hypnotizable individuals', 'Eight healthy post-menopausal women']","['appetite sensations measurements', 'hypnosis-induced hallucinated breakfast (HB', 'hypnosis-induced hallucinated meal', 'real breakfast (RB']","['Energy intakes', 'free fatty acid', 'subjective appetite and appetite-regulating hormones', 'Postprandial neuropeptide-Y and orexin', 'acylated-ghrelin and leptin levels', 'postprandial levels of glucagon-like-peptide-1 and peptide-YY', 'Appetite sensation']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0027893', 'cui_str': 'Neuropeptide Y'}, {'cui': 'C1113688', 'cui_str': 'Orexin'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",,0.059508,"As expected, significantly higher glucose (p < 0.001), insulin (p < 0.001), and lower free fatty acid (p < 0.001) concentrations were found after the RB, but not following HB.","[{'ForeName': 'Iolanda', 'Initials': 'I', 'LastName': 'Cioffi', 'Affiliation': 'Department of Medical Sciences, University of Turin, c.so AM Dogliotti 14, 10126, Turin, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Gambino', 'Affiliation': 'Department of Medical Sciences, University of Turin, c.so AM Dogliotti 14, 10126, Turin, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Rosato', 'Affiliation': 'Department of Psychology, University of Turin, Turin, Italy.'}, {'ForeName': 'Bice', 'Initials': 'B', 'LastName': 'Properzi', 'Affiliation': 'Unit of Internal Medicine, Hospital of Turin, Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Regaldo', 'Affiliation': 'Obstetric Department, Hospital of Ciriè, Turin, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ponzo', 'Affiliation': 'Department of Medical Sciences, University of Turin, c.so AM Dogliotti 14, 10126, Turin, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Medical Sciences, University of Turin, c.so AM Dogliotti 14, 10126, Turin, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Contaldo', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Pasanisi', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Ezio', 'Initials': 'E', 'LastName': 'Ghigo', 'Affiliation': 'Department of Medical Sciences, University of Turin, c.so AM Dogliotti 14, 10126, Turin, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bo', 'Affiliation': 'Department of Medical Sciences, University of Turin, c.so AM Dogliotti 14, 10126, Turin, Italy. simona.bo@unito.it.'}]",Reviews in endocrine & metabolic disorders,['10.1007/s11154-020-09559-4']
2229,31022102,Tobacco Evidence-Based Practice Implementation and Employee Tobacco-Related Outcomes at Small Low-Wage Worksites.,"OBJECTIVE


The aim of this study was to assess whether tobacco policy, program, and communication evidence-based practice implementation is associated with employee tobacco outcomes [current smoking; quit attempt; smokeless tobacco (SLT) use; and perceived worksite support for cessation] at small low-wage worksites.
METHODS


We analyzed data from a randomized controlled trial testing an intervention to increase implementation of evidence-based health promotion practices. We used generalized estimating equations to examine relationships between practice implementation and tobacco outcomes.
RESULTS


Communication practice implementation was associated with better perceived worksite support for cessation (P = 0.027). Policy and program implementation were associated with increased odds of being a current SLT user; these findings should be interpreted with caution given small sample sizes.
CONCLUSION


Tobacco communication evidence-based practice implementation was associated with favorable perceptions of worksite support for cessation; more may be needed to change tobacco use behavior.",2019,"RESULTS


Communication practice implementation was associated with better perceived worksite support for cessation (P = 0.027).",[],[],[],[],[],[],,0.15325,"RESULTS


Communication practice implementation was associated with better perceived worksite support for cessation (P = 0.027).","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Kava', 'Affiliation': 'Health Promotion Research Center, Department of Health Services, University of Washington, Seattle, Washington (Dr Kava, Dr Harris, Ms Kohn, Ms Parrish, Dr Hannon), and Department of Biostatistics, University of Washington, Seattle, Washington (Dr Gary Chan).'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Kwun C', 'Initials': 'KC', 'LastName': 'Gary Chan', 'Affiliation': ''}, {'ForeName': 'Marlana J', 'Initials': 'MJ', 'LastName': 'Kohn', 'Affiliation': ''}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Parrish', 'Affiliation': ''}, {'ForeName': 'Peggy A', 'Initials': 'PA', 'LastName': 'Hannon', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001618']
2230,32420825,Group social work intervention enhances the sexual satisfaction of women with Multiple Sclerosis: a randomized controlled trial study.,"Sexual problems are among the most common disorders that people with Multiple Sclerosis have to deal with, resulting in decreased sexual satisfaction and quality of life. The study is aimed to investigate the impact of group social work intervention on the sexual satisfaction of women with Multiple Sclerosis. The methodology was a randomized controlled trial and 58 participants recruited (30 for control group and 28 for intervention group). The intervention was based on group social work with an empowerment approach within eight sessions. The average age of the participants was 35.95 ± 6.41 most of whom had high school diploma (62.1%). The findings indicate that, in terms of sexual satisfaction (t = 5.47, Sig = 0.03, df = 56), primary disorders (t = 2.42, Sig = 0.019, df = 56), and tertiary disorders (t = 3.77, Sig = 0.002, df = 56), there is a significant difference between intervention and control groups.",2020,", there is a significant difference between intervention and control groups.","['The average age of the participants was 35.95\xa0±', 'df\xa0=\xa056', 'women with Multiple Sclerosis', '58 participants recruited (30 for control group and 28 for intervention group']",['social work intervention'],"['sexual satisfaction', 'sexual satisfaction and quality of life', 'tertiary disorders']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",58.0,0.0694324,", there is a significant difference between intervention and control groups.","[{'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Arshi', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}, {'ForeName': 'Fahime', 'Initials': 'F', 'LastName': 'Sheybani', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Eghlima', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Shati', 'Affiliation': 'Mental Health Research Center, Social Injury Prevention Research Institute, Iran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Moghanibashi-Mansourieh', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Moshayyedi', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}]",Social work in health care,['10.1080/00981389.2020.1762148']
2231,26259833,Factors associated with breast milk intake among 9-10-month-old Malawian infants.,"Exclusive breastfeeding is recommended during the first 6 months of life; thereafter, continued breastfeeding along with nutritious complementary foods is recommended. Continued breastfeeding contributes a substantial proportion of nutrient needs and promotes healthy growth and development, but the quantity of breast milk consumed may be highly variable and little is known about the factors associated with breast milk intake after 6 months of age. The present study was conducted to assess factors associated with breast milk intake of Malawian infants at 9-10 months of age. Breast milk intake was measured using the dose-to-mother deuterium oxide dilution method in a subsample of 358 Malawian infants who were participating in a randomized controlled trial of lipid-based nutrient supplements. Regression analysis was used to assess associations between breast milk intake and several maternal and infant variables. Mean (standard deviation) breast milk intake was 752 (244) g day(-1) . In multiple regression, breast milk intake was positively associated with infant weight (+62 g per kg body weight, P < 0.01) and maternal height (P < 0.01) and negatively associated with maternal education and age (P < 0.01). There was a non-significant (P = 0.063) inverse association between energy from non-breast milk sources and breast milk intake. In this rural Malawian population, infant weight is the main predictor of breast milk intake, even after the first 6 months of life.",2016,There was a non-significant (P = 0.063) inverse association between energy from non-breast milk sources and breast milk intake.,"['9-10-month-old Malawian infants', 'Malawian infants at 9-10 months of age', '358 Malawian infants who were participating', 'breast milk intake was 752 (244']",['lipid-based nutrient supplements'],"['Mean (standard deviation', 'maternal height', 'infant weight', 'breast milk intake', 'Breast milk intake']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0556182', 'cui_str': 'Breast milk intake (observable entity)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0556182', 'cui_str': 'Breast milk intake (observable entity)'}]",,0.0307723,There was a non-significant (P = 0.063) inverse association between energy from non-breast milk sources and breast milk intake.,"[{'ForeName': 'Chiza', 'Initials': 'C', 'LastName': 'Kumwenda', 'Affiliation': 'Department for International Health, University of Tampere School of Medicine, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Jaimie', 'Initials': 'J', 'LastName': 'Hemsworth', 'Affiliation': 'Department of Population Health, Nutrition Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Phuka', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Arimond', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Department for International Health, University of Tampere School of Medicine, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Department for International Health, University of Tampere School of Medicine, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Marjorie J', 'Initials': 'MJ', 'LastName': 'Haskell', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA. kgdewey@ucdavis.edu.'}]",Maternal & child nutrition,['10.1111/mcn.12199']
2232,31072467,"Response to: A Phase III open-label, randomized, active controlled clinical study to assess safety, immunogenicity and lot-to-lot consistency of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants.",,2019,,['Indian infants'],['bovine-human reassortant pentavalent rotavirus vaccine'],[],"[{'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2713569', 'cui_str': 'pentavalent rotavirus vaccine (RV5)'}]",[],,0.0410817,,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gillard', 'Affiliation': 'GlaxoSmithKline, Avenue Fleming, 20, Wavre B1300, Belgium. Electronic address: Paul.gillard@gsk.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Benninghoff', 'Affiliation': 'GlaxoSmithKline, Avenue Fleming, 20, Wavre B1300, Belgium. Electronic address: Bernd.x.benninghoff@gsk.com.'}]",Vaccine,['10.1016/j.vaccine.2019.04.003']
2233,26081224,Incorporation of eicosapentaenioic and docosahexaenoic acids into breast adipose tissue of women at high risk of breast cancer: a randomized clinical trial of dietary fish and n-3 fatty acid capsules.,"SCOPE


The fatty acid profile of dietary lipids is reflected in mammary adipose tissue and may influence mammary gland biology and cancer risk. To determine the effects of fish consumption on breast adipose tissue fatty acids, we conducted a study of fish versus n-3 PUFA supplements in women at increased risk of breast cancer.
METHODS AND RESULTS


High risk women were randomized to comparable doses of marine n-3 PUFAs as canned salmon + albacore or capsules for 3 months. Pre- and posttreatment fatty acid profiles were obtained by GC. Dietary fish (n = 12) and n-3 PUFA capsules (n = 13) yielded increased eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma (p < 0.0001), erythrocyte membranes (p < 0.0001), and breast fat (p < 0.01) at 3 months. Women taking capsules had higher plasma and erythrocyte membrane EPA changes (∼four versus twofold, p = 0.002), without significant differences in DHA. Increases in breast adipose EPA, DHA were similar for both groups. Higher BMI correlated with smaller changes in plasma, erythrocyte membrane EPA, and breast adipose EPA, DHA. Adherence was excellent at 93.9% overall and higher in the fish arm (p = 0.01).
CONCLUSION


Fish provides an excellent source of n-3 PUFAs that increases breast adipose EPA, DHA similar to supplements and represents a well-tolerated intervention for future studies of the impact of n-3 PUFAs and dietary patterns on breast cancer.",2015,"Women taking capsules had higher plasma and erythrocyte membrane EPA changes (∼four versus twofold, p = 0.002), without significant differences in DHA.","['High risk women', 'women at high risk of breast cancer', 'women at increased risk of breast cancer']","['dietary fish and n-3 fatty acid capsules', 'marine n-3 PUFAs', 'n-3 PUFA capsules', 'eicosapentaenioic and docosahexaenoic acids', 'n-3 PUFA supplements']","['Higher BMI', 'erythrocyte membranes', 'higher plasma and erythrocyte membrane EPA changes', 'plasma, erythrocyte membrane EPA, and breast adipose EPA, DHA', 'eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma', 'breast adipose EPA, DHA', 'Pre- and posttreatment fatty acid profiles', 'Adherence']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0014780', 'cui_str': 'Erythrocyte Cytoskeleton'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}]",,0.138727,"Women taking capsules had higher plasma and erythrocyte membrane EPA changes (∼four versus twofold, p = 0.002), without significant differences in DHA.","[{'ForeName': 'Shana', 'Initials': 'S', 'LastName': 'Straka', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Joanne L', 'Initials': 'JL', 'LastName': 'Lester', 'Affiliation': 'College of Nursing, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Cole', 'Affiliation': 'Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Andridge', 'Affiliation': 'Division of Biostatistics, College of Public Health, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Puchala', 'Affiliation': 'Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Rose', 'Affiliation': 'Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Clinton', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Belury', 'Affiliation': 'Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Yee', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, The Ohio State University, Columbus, Ohio, USA.'}]",Molecular nutrition & food research,['10.1002/mnfr.201500161']
2234,32417770,"The MARBLE Study Protocol: Modulating ApoE Signaling to Reduce Brain Inflammation, DeLirium, and PostopErative Cognitive Dysfunction.","BACKGROUND


Perioperative neurocognitive disorders (PND) are common complications in older adults associated with increased 1-year mortality and long-term cognitive decline. One risk factor for worsened long-term postoperative cognitive trajectory is the Alzheimer's disease (AD) genetic risk factor APOE4. APOE4 is thought to elevate AD risk partly by increasing neuroinflammation, which is also a theorized mechanism for PND. Yet, it is unclear whether modulating apoE4 protein signaling in older surgical patients would reduce PND risk or severity.
OBJECTIVE


MARBLE is a randomized, blinded, placebo-controlled phase II sequential dose escalation trial designed to evaluate perioperative administration of an apoE mimetic peptide drug, CN-105, in older adults (age≥60 years). The primary aim is evaluating the safety of CN-105 administration, as measured by adverse event rates in CN-105 versus placebo-treated patients. Secondary aims include assessing perioperative CN-105 administration feasibility and its efficacy for reducing postoperative neuroinflammation and PND severity.
METHODS


201 patients undergoing non-cardiac, non-neurological surgery will be randomized to control or CN-105 treatment groups and receive drug or placebo before and every six hours after surgery, for up to three days after surgery. Chart reviews, pre- and postoperative cognitive testing, delirium screening, and blood and CSF analyses will be performed to examine effects of CN-105 on perioperative adverse event rates, cognition, and neuroinflammation. Trial results will be disseminated by presentations at conferences and peer-reviewed publications.
CONCLUSION


MARBLE is a transdisciplinary study designed to measure CN-105 safety and efficacy for preventing PND in older adults and to provide insight into the pathogenesis of these geriatric syndromes.",2020,"Secondary aims include assessing perioperative CN-105 administration feasibility and its efficacy for reducing postoperative neuroinflammation and PND severity.
","['older adults', 'treated patients', '201 patients undergoing non-cardiac, non-neurological surgery', 'older surgical patients', ""Alzheimer's disease (AD) genetic risk factor"", 'older adults (age≥60 years']","['CN-105 versus placebo', 'CN-105', 'control or CN-105 treatment groups and receive drug or placebo', 'placebo']","['perioperative adverse event rates, cognition, and neuroinflammation', '1-year mortality', 'adverse event rates', 'postoperative neuroinflammation and PND severity', 'Brain Inflammation, DeLirium, and PostopErative Cognitive Dysfunction', 'CN-105 safety and efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0014038', 'cui_str': 'Encephalitis'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",201.0,0.0801323,"Secondary aims include assessing perioperative CN-105 administration feasibility and its efficacy for reducing postoperative neuroinflammation and PND severity.
","[{'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'VanDusen', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sarada', 'Initials': 'S', 'LastName': 'Eleswarpu', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Eugene W', 'Initials': 'EW', 'LastName': 'Moretti', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Devinney', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Crabtree', 'Affiliation': 'Duke Office of Clinical Research, Duke University, Durham, NC, USA.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Laskowitz', 'Affiliation': 'Department of Neurology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Marty G', 'Initials': 'MG', 'LastName': 'Woldorff', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Roberts', 'Affiliation': 'Center for Cognitive Neuroscience, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Whittle', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Browndyke', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Cooter', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Oke', 'Initials': 'O', 'LastName': 'Anakwenze', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, Durham, NC, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Bolognesi', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, Durham, NC, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Easley', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, Durham, NC, USA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Ferrandino', 'Affiliation': 'Department of Surgery, Duke University, Durham, NC, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Jiranek', 'Affiliation': 'Department of Surgery, Duke University, Durham, NC, USA.'}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': 'Department of Anesthesiology, Duke University, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191185']
2235,32417893,Peak expiratory flow in the standing and sitting positions is equivalent in adults: a cross-over study.,"BACKGROUND


It is uncertain whether peak flow measurement is best done in the standing or sitting position.
METHODS


In this cross-over study, study participants were randomized to perform the initial peak expiratory flow (PEF) measurement in either standing or sitting position. The highest of three readings in each position were compared using paired t-test. A mean difference of <±25 l/min was set as the equivalence limits. Test of equivalence of standing and sitting PEF measurements was done using MedCalc Software. Test of agreement of standing and sitting PEF was assessed by Lin's concordance correlation coefficient and Bland-Altman limits of agreement.
RESULTS


Of the 100 study participants, 50% of them had asthma. There was a statistically significant difference between the standing and sitting PEF in adults suffering from asthma [mean difference 11 l/min, 95% confidence interval (CI) = 4 to 19], but not in the healthy individuals (mean difference 3 l/min, 95% CI = -6 to 12). The observed differences in PEF were small and may not be clinically important. In adults with and without asthma, the standing and sitting PEF were highly correlated and satisfied the test of equivalence.
CONCLUSIONS


The PEF in the standing and sitting positions was equivalent in adults. Therefore, performing PEF in either position is acceptable. However, health care practitioners should be aware of the small reduction in PEF when it is done in the sitting position. It is desirable that the position used is documented and the same position is used wherever possible.",2020,"There was a statistically significant difference between the standing and sitting PEF in adults suffering from asthma [mean difference 11 l/min, 95% confidence interval (CI) = 4 to 19], but not in the healthy individuals (mean difference 3 l/min, 95% CI","['Of the 100 study participants, 50% of them had asthma', 'adults']",[],"['standing and sitting PEF', 'Peak expiratory flow', 'initial peak expiratory flow (PEF) measurement']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",100.0,0.0595707,"There was a statistically significant difference between the standing and sitting PEF in adults suffering from asthma [mean difference 11 l/min, 95% confidence interval (CI) = 4 to 19], but not in the healthy individuals (mean difference 3 l/min, 95% CI","[{'ForeName': 'Cheong Lieng', 'Initials': 'CL', 'LastName': 'Teng', 'Affiliation': 'Department of Family Medicine, International Medical University, Jalan Rasah, Seremban, Malaysia.'}, {'ForeName': 'Kun Mun', 'Initials': 'KM', 'LastName': 'Chia', 'Affiliation': 'Klinik Kesihatan Sentul, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': ""D'Cruz"", 'Affiliation': 'Poliklinik Gomez, Ampang, Malaysia.'}, {'ForeName': 'Colin Adrian', 'Initials': 'CA', 'LastName': 'Gomez', 'Affiliation': 'Poliklinik Gomez, Puchong Jaya, Malaysia.'}, {'ForeName': 'Nesalatchumy', 'Initials': 'N', 'LastName': 'Muthusamy', 'Affiliation': 'Klinik Kesihatan Tanglin, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nur Syahida', 'Initials': 'NS', 'LastName': 'Saadon', 'Affiliation': 'Klinik Kesihatan Gombak Setia, Gombak, Malaysia.'}, {'ForeName': 'Noraini Mat', 'Initials': 'NM', 'LastName': 'Jali', 'Affiliation': 'Klinik Kesihatan Sungai Besar, Sungai Besar, Malaysia.'}, {'ForeName': 'Li Cher', 'Initials': 'LC', 'LastName': 'Loh', 'Affiliation': 'School of Postgraduate Studies, International Medical University, Kuala Lumpur, Malaysia.'}]",Family practice,['10.1093/fampra/cmaa048']
2236,32417976,"Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial.","PURPOSE


This trial was conducted to confirm the non-inferiority of remimazolam versus propofol in the induction and maintenance of general anesthesia in surgical patients.
METHODS


Surgical patients (n = 375) were randomized to remimazolam started at 6 or 12 mg/kg/h by continuous intravenous (IV) infusion until the loss of consciousness (LoC), followed by 1 mg/kg/h to be adjusted as appropriate until the end of surgery or IV propofol administered as a slow bolus of 2.0-2.5 mg/kg until LoC followed by 4-10 mg/kg/h until the end of surgery. Efficacy was measured via the combined primary endpoint of no intraoperative awakening/recall, no need for rescue sedatives, and no body movements. Adverse events and adverse drug reactions (ADRs) were monitored for safety.
RESULTS


Efficacy rates were 100% in all treatment groups, and the non-inferiority of remimazolam was demonstrated [95% confidence interval (- 0.0487; 0.0250)]. The time to LoC was longer in the remimazolam 6 (p < 0.0001) and 12 mg/kg/h (p = 0.0149) groups versus propofol. The time to extubation was longer in both remimazolam groups versus the propofol group (p ≤ 0.0001). The incidence of ADRs was similar in the remimazolam groups (39.3% and 42.7%, respectively) compared with the propofol group (61.3%). Decreased blood pressure occurred in 20.0% and 24.0% of patients treated with 6 and 12 mg/kg/h remimazolam, respectively, compared with 49.3% of patients receiving propofol. Injection site pain was reported in 18.7% of propofol patients but not in those receiving remimazolam.
CONCLUSIONS


This trial demonstrated that remimazolam was well tolerated and non-inferior to propofol with regard to efficacy as a sedative hypnotics for general anesthesia.
CLINICAL TRIAL REGISTRATION


This trial is registered with the Japan Pharmaceutical Information Center - Clinical Trials Information (JapicCTI). JapicCTI number: 121973.",2020,The time to LoC was longer in the remimazolam 6 (p < 0.0001) and 12 mg/kg/h (p = 0.0149) groups versus propofol.,"['Surgical patients (n\u2009=\u2009375', 'general anesthesia', 'surgical patients']","['propofol', 'remimazolam', 'remimazolam versus propofol']","['blood pressure', 'time to LoC', 'Injection site pain', 'time to extubation', 'Efficacy and safety', 'intraoperative awakening/recall, no need for rescue sedatives, and no body movements', 'incidence of ADRs', 'Efficacy', 'Adverse events and adverse drug reactions (ADRs', 'Efficacy rates']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0041657', 'cui_str': 'Loss of consciousness'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.184452,The time to LoC was longer in the remimazolam 6 (p < 0.0001) and 12 mg/kg/h (p = 0.0149) groups versus propofol.,"[{'ForeName': 'Matsuyuki', 'Initials': 'M', 'LastName': 'Doi', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Hamamatsu University Hospital, 1-20-1 Handayama, Higashi-Ku, Hamamatsu-Shi, 431-3192, Japan. matsuyuki_doi@nifty.com.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Morita', 'Affiliation': 'Okayama University, Okayama, Japan.'}, {'ForeName': 'Junzo', 'Initials': 'J', 'LastName': 'Takeda', 'Affiliation': 'Keio University, Tokyo, Japan.'}, {'ForeName': 'Atsuhiro', 'Initials': 'A', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Anesthesiology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Toshiyasu', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Anesthesiology, Tokai University of Medicine, Isehara, Kanagawa, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02788-6']
2237,26112041,A group randomized controlled trial integrating obesity prevention and control for postpartum adolescents in a home visiting program.,"BACKGROUND


Adolescence represents a critical period for the development of overweight that tracks into adulthood. This risk is significantly heightened for adolescents that become pregnant, many of whom experience postpartum weight retention. The aim of this study was to evaluate Balance Adolescent Lifestyle Activities and Nutrition Choices for Energy (BALANCE), a multicomponent obesity prevention intervention targeting postpartum adolescents participating in a national home visiting child development-parent education program.
METHODS


A group randomized, nested cohort design was used with 1325 adolescents, 694 intervention and 490 control, (mean age = 17.8 years, 52 % underrepresented minorities) located across 30 states. Participatory methods were used to integrate lifestyle behavior change strategies within standard parent education practice. Content targeted replacement of high-risk obesogenic patterns (e.g. sweetened drink and high fat snack consumption, sedentary activity) with positive behaviors (e.g. water intake, fruit and vegetables, increased walking). Parent educators delivered BALANCE through home visits, school based classroom-group meetings, and website activities. Control adolescents received standard child development information. Phase I included baseline to posttest (12 months); Phase II included baseline to follow-up (24 months).
RESULTS


When compared to the control group, BALANCE adolescents who were ≥12 weeks postpartum were 89 % more likely (p = 0.02) to maintain a normal BMI or improve an overweight/obese BMI by 12 months; this change was not sustained at 24 months. When compared to the control group, BALANCE adolescents significantly improved fruit and vegetable intake (p = .03). In stratified analyses, water intake improved among younger BALANCE teens (p = .001) and overweight/obese BALANCE teens (p = .05) when compared to control counterparts. There were no significant differences between groups in sweetened drink and snack consumption or walking.
CONCLUSION


Prevention of postpartum weight retention yields immediate health benefits for the adolescent mother and may prevent the early development or progression of maternal obesity, which contributes to the intergenerational transmission of obesity to her offspring. Implementing BALANCE through a national home visiting organization may hold promise for promoting positive lifestyle behaviors associated with interruption of the progression of maternal obesity.
TRIAL REGISTRATION


Clinical Trials Registry NCT01617486 .",2015,"In stratified analyses, water intake improved among younger BALANCE teens (p = .001) and overweight/obese BALANCE teens (p = .05) when compared to control counterparts.","['postpartum adolescents in a home visiting program', 'postpartum adolescents participating in a national home visiting child development-parent education program', '1325 adolescents, 694 intervention and 490 control, (mean age\u2009=\u200917.8\xa0years, 52\xa0% underrepresented minorities) located across 30 states']","['multicomponent obesity prevention intervention', 'standard child development information', 'obesity prevention and control']","['sweetened drink and snack consumption or walking', 'normal BMI or improve an overweight/obese BMI', 'Balance Adolescent Lifestyle Activities', 'fruit and vegetable intake']","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0242261', 'cui_str': 'Parenting Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]",,0.0494125,"In stratified analyses, water intake improved among younger BALANCE teens (p = .001) and overweight/obese BALANCE teens (p = .05) when compared to control counterparts.","[{'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Haire-Joshu', 'Affiliation': 'Washington University in St. Louis, The Brown School of Social Work and Public Health, and The School of Medicine, 1 Brookings Dr, St. Louis, MO, 63130, USA. djoshu@wustl.edu.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Schwarz', 'Affiliation': 'Washington University in St. Louis, The Brown School of Social Work and Public Health, and The School of Medicine, 1 Brookings Dr, St. Louis, MO, 63130, USA. cschwarz@wustl.edu.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Peskoe', 'Affiliation': 'Harvard School of Public Health, 677 Huntington Avenue, Boston, MA, 02115, USA. speskoe@fas.harvard.edu.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Budd', 'Affiliation': 'Washington University in St. Louis, The Brown School of Social Work and Public Health, and The School of Medicine, 1 Brookings Dr, St. Louis, MO, 63130, USA. ebudd@wustl.edu.'}, {'ForeName': 'Ross C', 'Initials': 'RC', 'LastName': 'Brownson', 'Affiliation': 'Washington University in St. Louis, The Brown School of Social Work and Public Health, and The School of Medicine, 1 Brookings Dr, St. Louis, MO, 63130, USA. rbrownson@wustl.edu.'}, {'ForeName': 'Corinne E', 'Initials': 'CE', 'LastName': 'Joshu', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21218, USA. cjoshu1@jhu.edu.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-015-0247-8']
2238,32418078,"Postoperative Adjuvant Transarterial Infusion Chemotherapy with FOLFOX Could Improve Outcomes of Hepatocellular Carcinoma Patients with Microvascular Invasion: A Preliminary Report of a Phase III, Randomized Controlled Clinical Trial.","BACKGROUND


Microvascular invasion (MVI) is a risk factor for tumor recurrence after hepatectomy in hepatocellular carcinoma (HCC) patients.
OBJECTIVE


This study aimed to investigate the efficacy and safety of postoperative adjuvant transarterial infusion chemotherapy (TAI) with the FOLFOX regimen for HCC patients with MVI.
METHODS


In this prospective, phase III, randomized, open-label, controlled clinical trial, HCC patients with histologically confirmed MVI were randomly assigned (1:1) after hepatectomy to receive either one to two cycles of adjuvant TAI (AT group) or follow-up without any adjuvant treatment (FU group). The primary endpoint was disease-free survival (DFS), while secondary endpoints were overall survival (OS) and safety.
RESULTS


Between June 2016 and April 2019, 127 patients were randomly assigned to the AT group (n = 63) or FU group (n = 64). Clinicopathological characteristics of the two groups were well-balanced. The 6-, 12-, and 18-month OS rates for the AT group were 100.0%, 97.7%, and 97.7%, respectively, and 94.5%, 89.6%, and 78.5% for the FU group, respectively. The 6-, 12-, and 18-month DFS rates for the AT and FU groups were 84.7%, 61.8%, and 58.7%, and 62.9%, 48.1%, and 38.6%, respectively. OS and DFS were significantly better in the AT group than in the FU group (p = 0.037 and 0.023, respectively). No patients in the AT group experienced grade 3 or more severe adverse events.
CONCLUSIONS


Adjuvant TAI after hepatectomy may bring survival benefits to HCC patients with MVI.
TRIAL REGISTRATION


Trial number: NCT03192618.",2020,"OS and DFS were significantly better in the AT group than in the FU group (p = 0.037 and 0.023, respectively).","['Between June 2016 and April 2019', 'Hepatocellular Carcinoma Patients with Microvascular Invasion', 'hepatocellular carcinoma (HCC) patients', 'HCC patients with histologically confirmed MVI', 'HCC patients with MVI', '127 patients']","['adjuvant TAI (AT group) or follow-up without any adjuvant treatment (FU group', 'FU', 'postoperative adjuvant transarterial infusion chemotherapy (TAI', 'FOLFOX']","['OS and DFS', 'OS rates', 'severe adverse events', 'survival benefits', 'efficacy and safety', 'DFS rates', 'overall survival (OS) and safety', 'disease-free survival (DFS']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",127.0,0.100369,"OS and DFS were significantly better in the AT group than in the FU group (p = 0.037 and 0.023, respectively).","[{'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Qiaoxuan', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhixing', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Lianghe', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Minshan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Lie', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Wenping', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Rongping', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. guorp@sysucc.org.cn.""}]",Annals of surgical oncology,['10.1245/s10434-020-08601-8']
2239,31547949,Evaluation of the efficacy of different treatment modalities for painful temporomandibular disorders.,"The purpose of this study was to clinically evaluate the efficacies of three treatment methods and to compare their outcomes in patients with painful disc displacement. The study group comprised 45 patients with unilateral temporomandibular disorders who fell into Axis I group II (with limited mouth opening) of the Research Diagnostic Criteria for Temporomandibular Disorders. Magnetic resonance imaging was used for definitive diagnosis. The patients were divided randomly into three groups according to the treatment method: splint therapy, splint therapy with ultrasound-guided arthrocentesis, and splint therapy with low-level laser therapy. Patients were followed up after treatment for 6 months. The groups were compared in terms of pain and functional jaw movements (unassisted mouth opening without pain, maximum unassisted mouth opening, and contralateral movements). At the end of treatment, functional jaw movements were significantly increased while pain values were significantly decreased in all groups (P<0.05). Group 2 had a quicker improvement in terms of mouth opening scores at the end of the first month, and unassisted mouth opening without pain was found to be more than 35 millimetres in all groups at the end of 6 months. All treatment modalities showed effective results on pain and functional jaw movements in the treatment of temporomandibular disorders.",2020,"At the end of treatment, functional jaw movements were significantly increased while pain values were significantly decreased in all groups (P<0.05).","['patients with painful disc displacement', 'painful temporomandibular disorders', '45 patients with unilateral temporomandibular disorders who fell into Axis I group II (with limited mouth opening) of the Research Diagnostic Criteria for Temporomandibular Disorders']","['Magnetic resonance imaging', 'splint therapy, splint therapy with ultrasound-guided arthrocentesis, and splint therapy with low-level laser therapy']","['pain values', 'pain and functional jaw movements', 'pain and functional jaw movements (unassisted mouth opening without pain, maximum unassisted mouth opening, and contralateral movements', 'unassisted mouth opening without pain', 'functional jaw movements', 'mouth opening scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0204854', 'cui_str': 'Arthrocentesis'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",45.0,0.0182591,"At the end of treatment, functional jaw movements were significantly increased while pain values were significantly decreased in all groups (P<0.05).","[{'ForeName': 'Z S', 'Initials': 'ZS', 'LastName': 'Abbasgholizadeh', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Marmara University, Istanbul, Turkey. Electronic address: zeliha.sanivar@marmara.edu.tr.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Evren', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ozkan', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.08.010']
2240,31549208,Implantation of mesenchymal stem cells in combination with allogenic cartilage improves cartilage regeneration and clinical outcomes in patients with concomitant high tibial osteotomy.,"PURPOSE


This study aimed to compare the clinical, radiological, and second-look arthroscopic outcomes of implanting mesenchymal stem cells (MSCs) alone and together with allogenic cartilage in patients treated with concomitant high tibial oteotomy (HTO) for varus knee osteoarthritis.
METHODS


Eighty patients treated with cartilage repair procedures and concomitant HTO were prospectively randomized into two groups: MSC implantation (MSC group), and MSC implantation with allogenic cartilage (MSC-AC group). Clinical outcomes were evaluated using the Lysholm Score and the Knee Injury and Osteoarthritis Outcome Score (KOOS) at preoperative and every follow-up visit. Radiological outcomes were evaluated by measuring the femorotibial angle and posterior tibial slope. During second-look arthroscopy, cartilage regeneration was evaluated according to the Kanamiya grade.
RESULTS


Clinical outcomes at the second-look arthroscopy (mean 12.5 months [MSC group] and 12.4 months [MSC-AC group]) improved significantly in both groups (P < 0.001 for all). Clinical outcomes from the second-look arthroscopy to the final follow-up (mean 27.3 months [MSC group] and 27.8 months [MSC-AC group]) improved further only in the MSC-AC group (P < 0.05 for all). Overall, the Kanamiya grades, which were significantly correlated with clinical outcomes, were significantly higher in the MSC-AC group than in the MSC group. Radiological outcomes at final follow-up revealed improved knee joint alignments relative to preoperative conditions but without significant correlation between clinical outcomes and Kanamiya grade in either group (n.s. for all).
CONCLUSION


Implantation of MSCs with allogenic cartilage is superior to implantation of MSCs alone in cartilage regeneration accompanied with better clinical outcomes.
LEVEL OF EVIDENCE


Therapeutic study, level II.",2020,"Radiological outcomes at final follow-up revealed improved knee joint alignments relative to preoperative conditions but without significant correlation between clinical outcomes and Kanamiya grade in either group (n.s. for all).
","['patients treated with concomitant high tibial oteotomy (HTO) for varus knee osteoarthritis', 'patients with concomitant high tibial osteotomy', 'Eighty patients treated with cartilage repair procedures and concomitant HTO']","['MSC implantation (MSC group), and MSC implantation with allogenic cartilage (MSC-AC group', 'implanting mesenchymal stem cells (MSCs) alone and together with allogenic cartilage', 'allogenic cartilage', 'MSC']","['femorotibial angle and posterior tibial slope', 'Radiological outcomes', 'knee joint alignments', 'Lysholm Score and the Knee Injury and Osteoarthritis Outcome Score (KOOS', 'cartilage regeneration and clinical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0443345', 'cui_str': 'Varus (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia (procedure)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}]","[{'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0349676', 'cui_str': 'Regeneration - action (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",80.0,0.0390516,"Radiological outcomes at final follow-up revealed improved knee joint alignments relative to preoperative conditions but without significant correlation between clinical outcomes and Kanamiya grade in either group (n.s. for all).
","[{'ForeName': 'Yong Sang', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Stem Cell and Arthritis Research, Yonsei Sarang Hospital, 478-3, Bangbae-dong, Seocho-gu, Seoul, 137-060, South Korea.'}, {'ForeName': 'Pill Ku', 'Initials': 'PK', 'LastName': 'Chung', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Stem Cell and Arthritis Research, Yonsei Sarang Hospital, 478-3, Bangbae-dong, Seocho-gu, Seoul, 137-060, South Korea.'}, {'ForeName': 'Dong Suk', 'Initials': 'DS', 'LastName': 'Suh', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Stem Cell and Arthritis Research, Yonsei Sarang Hospital, 478-3, Bangbae-dong, Seocho-gu, Seoul, 137-060, South Korea.'}, {'ForeName': 'Dong Beom', 'Initials': 'DB', 'LastName': 'Heo', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Stem Cell and Arthritis Research, Yonsei Sarang Hospital, 478-3, Bangbae-dong, Seocho-gu, Seoul, 137-060, South Korea.'}, {'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Tak', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Stem Cell and Arthritis Research, Yonsei Sarang Hospital, 478-3, Bangbae-dong, Seocho-gu, Seoul, 137-060, South Korea.'}, {'ForeName': 'Yong Gon', 'Initials': 'YG', 'LastName': 'Koh', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Stem Cell and Arthritis Research, Yonsei Sarang Hospital, 478-3, Bangbae-dong, Seocho-gu, Seoul, 137-060, South Korea. yonggonkoh@gmail.com.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05729-3']
2241,32418143,"Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Acetylsalicylic Acid in Fixed-Dose Combination with Clopidogrel Versus Enteric Aspirin in Chinese Subjects Under Fasting Conditions: A Phase 1, Open-Label, Randomized, Crossover Study.","INTRODUCTION


Dual antiplatelet therapy, aspirin and a P2Y 12  inhibitor, is recommended to prevent thrombotic complications of acute coronary syndrome. Clopidogrel plus acetylsalicylic acid combination is the most commonly used dual antiplatelet therapy recommended by international guidelines and in Chinese clinical practice. Poor adherence to dual antiplatelet therapy or premature interruption of dual antiplatelet therapy is an important contributor to cardiovascular mortality and lethal cardiovascular events. Clopidogrel + acetylsalicylic acid fixed-dose combination enhances adherence to dual antiplatelet therapy. Herein, we aimed to evaluate bioequivalence of acetylsalicylic acid and clopidogrel in fixed-dose combination compared with simultaneous administration of their individual formulations in healthy Chinese subjects under fasting conditions.
METHODS


This was a randomized, single-center, open-label, three-sequence, three-period, two-treatment, crossover study with a washout period of 10 days conducted in healthy Chinese volunteers. Subjects were randomized to receive Co-Plavix ®  (test formulation- fixed-dose combination of 100 mg acetylsalicylic acid and 75 mg clopidogrel) once and reference formulations (coadministration of individual formulations of 100 mg acetylsalicylic acid and 75 mg clopidogrel) twice during the study period. Pharmacokinetic parameters were analyzed for acetylsalicylic acid, its metabolite salicylic acid, clopidogrel, and its metabolite SR26334. As acetylsalicylic acid shows high intrasubject variability, the reference-scaled average bioequivalence (RSABE) approach was implemented for acetylsalicylic acid analysis, while bioequivalence of clopidogrel was assessed using the average bioequivalence method. Point ratios and confidence intervals (CIs) for AUC, AUC last , and C max  for acetylsalicylic acid and clopidogrel were calculated.
RESULTS


In total, 171 healthy subjects were enrolled in this study. Subjects were randomized and 170 subjects were treated with test or reference formulation; 164 subjects completed the study. Regarding acetylsalicylic acid exposure, as reference within-subject standard deviation (SD W ) was at least 0.294 for acetylsalicylic acid C max , AUC last , and AUC, the RSABE analysis method was used to assess bioequivalence for all three parameters. The point estimates were within the 0.80-1.25 range (1.19, 1.09, and 1.04, respectively), and upper one-sided 95% CIs of scaled average bioequivalence metric were at most 0 (- 0.30, - 0.14, and - 0.10, respectively). Thus, bioequivalence was demonstrated with acetylsalicylic acid. Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
CONCLUSION


Application of the reference-scaled average bioequivalence approach to evaluate bioequivalence of acetylsalicylic acid in Chinese male and female healthy volunteers under fasting conditions demonstrated bioequivalence of test and reference formulations.
TRIAL REGISTRATION


CTR20181695.",2020,"Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
","['171 healthy subjects', 'Subjects were randomized and 170 subjects were treated with test or reference formulation; 164 subjects completed the study', 'healthy Chinese subjects under fasting conditions', 'Chinese Subjects Under Fasting Conditions', 'healthy Chinese volunteers', 'Chinese male and female healthy volunteers']","['Clopidogrel plus acetylsalicylic acid combination', 'acetylsalicylic acid and 75\xa0mg clopidogrel', 'acetylsalicylic acid', 'acetylsalicylic acid and clopidogrel', 'aspirin', 'Clopidogrel Versus Enteric Aspirin', 'Co-Plavix ®  (test formulation- fixed-dose combination of 100\xa0mg acetylsalicylic acid and 75\xa0mg clopidogrel', 'Clopidogrel\u2009+\u2009acetylsalicylic acid']","['Point ratios and confidence intervals (CIs) for AUC, AUC last , and C max  for acetylsalicylic acid and clopidogrel', 'geometric mean ratios of clopidogrel C max , AUC last , and AUC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0633084', 'cui_str': 'Plavix'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",171.0,0.0504812,"Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Di', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Ming', 'Affiliation': 'Research and Development, Sanofi, New York, USA.'}, {'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Huiqiu', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Medical, Sanofi, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ping', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China. jie.hou@estartpoc.com.'}]",Advances in therapy,['10.1007/s12325-020-01369-z']
2242,32418145,Peri-transplant aminophylline in pediatric kidney transplant recipients of donation after brain death: a double-blinded placebo-controlled randomized clinical trial.,"BACKGROUND


During kidney transplantation, the transplanted kidney undergoes ischemia reperfusion injury, with adenosine being a major mediator. This study aimed to assess whether aminophylline, an adenosine receptor antagonist, improves early graft function and reduces incidence of delayed graft function (DGF) and slow graft function (SGF).
METHODS


Single center, double-blinded, placebo-controlled randomized clinical trial. Pediatric patients admitted for renal transplantation from donation after brain death donors were randomized into a treatment arm receiving aminophylline and a placebo arm receiving normal saline infusions. Primary outcome was estimated glomerular filtration rate (eGFR) at 5 days post-transplant. Secondary outcomes were rates of DGF/SGF and urinary neutrophil gelatinase-associated lipocalin (NGAL) levels.
RESULTS


Twenty-three patients were randomized to aminophylline and 27 to placebo. There was no difference in day 5 eGFR, rate of DGF/SGF, or urine NGAL/Creatinine level between aminophylline vs. placebo arm (eGFR 67.39 ± 38.9 ml/min/1.73m 2  vs. 80.48 ± 52.1 ml/min/1.73m 2 p = 0.32; DGF/SGF 5/23 (21.7%) vs. 3/27 (11.1%) p = 0.31; urine NGAL/creatinine 300.5 ng/mg IQR 105.5-1464.5 ng/mg vs. 425.4 ng/mg IQR 140.3-1126.2 ng/mg, p = 0.95; respectively). At 12 months, there was 100% patient survival and 98% graft survival. eGFR at 12 months was similar between the two arms.
CONCLUSIONS


There was no benefit in peri-transplant aminophylline administration. Our results are limited by small sample size, since sample calculations were based on primary outcome of day 5 eGFR and low rate of DGF/SGF, which may have precluded us from demonstrating efficacy. Further clinical studies are necessary to determine any benefit of aminophylline in kidney transplant recipients, particularly from high-risk donors.",2020,"There was no difference in day 5 eGFR, rate of DGF/SGF, or urine NGAL/Creatinine level between aminophylline vs. placebo arm (eGFR 67.39 ± 38.9 ","['kidney transplant recipients, particularly from high-risk donors', 'pediatric kidney transplant recipients of donation after brain death', 'Pediatric patients admitted for renal transplantation from donation after brain death donors', 'Twenty-three patients']","['aminophylline', 'placebo arm receiving normal saline infusions', 'aminophylline vs. placebo', 'Peri-transplant aminophylline', 'placebo']","['delayed graft function (DGF) and slow graft function (SGF', 'day 5 eGFR, rate of DGF/SGF, or urine NGAL/Creatinine level', 'eGFR', 'glomerular filtration rate (eGFR', 'patient survival and 98% graft survival', 'rates of DGF/SGF and urinary neutrophil gelatinase-associated lipocalin (NGAL) levels']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0450348', 'cui_str': '23'}]","[{'cui': 'C0002575', 'cui_str': 'Aminophylline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C1566590', 'cui_str': 'Delayed graft function'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",23.0,0.796399,"There was no difference in day 5 eGFR, rate of DGF/SGF, or urine NGAL/Creatinine level between aminophylline vs. placebo arm (eGFR 67.39 ± 38.9 ","[{'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Haskin', 'Affiliation': 'Department of Pediatrics (Nephrology), Stanford University School of Medicine, Stanford, CA, USA. orly.haskin@gmail.com.'}, {'ForeName': 'Weiwen', 'Initials': 'W', 'LastName': 'Shih', 'Affiliation': 'Department of Pediatrics (Nephrology), Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Wong', 'Affiliation': 'Department of Pediatrics (Nephrology), Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Axelrod', 'Affiliation': 'Department of Pediatrics (Cardiology), Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Grimm', 'Affiliation': 'Department of Pediatrics (Nephrology), Stanford University School of Medicine, Stanford, CA, USA.'}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04561-z']
2243,32418164,"Personalized Cognitive Counseling Reduces Drinking Expectancy Among Men Who Have Sex with Men and Transgender Women in Lima, Peru: A Pilot Randomized Controlled Trial.","Personalized cognitive counseling (PCC) is an evidence-based intervention designed to modify HIV-related risk behavior. We assessed the impact of PCC on sexual behavior, drinking expectancy, and incidence of sexually transmitted infections (STIs) in a 6-month randomized controlled trial among 153 HIV-uninfected men who have sex with men (MSM) and transgender women (TW) in Peru. Study retention was ≥ 90%, with three HIV infections (3 Control) and 19 cases of GC/CT (10 Control, 9 PCC) at 6 months. There was a decline in condomless receptive anal intercourse in the Control (0.74, 95% CI 0.60-0.91; p < 0.01) and PCC arms (0.72, 0.55-0.94; p = 0.02) at 6-month follow-up. There was a decrease in drinking expectancy at 6 months among participants endorsing alcohol use in the PCC arm (0.89, 0.83-0.96; p < 0.01), versus no change in the Control arm (0.98, 0.92-1.04; p = 0.54). PCC was efficacious in reducing drinking expectancy and HIV risk among MSM and TW in Peru.",2020,"There was a decline in condomless receptive anal intercourse in the Control (0.74, 95% CI 0.60-0.91; p < 0.01) and PCC arms (0.72, 0.55-0.94; p = 0.02) at 6-month follow-up.","['Who Have Sex with Men and Transgender Women in Lima, Peru', '153 HIV-uninfected men who have sex with men (MSM) and transgender women (TW) in Peru', 'Men']","['Personalized Cognitive Counseling', 'PCC', 'Personalized cognitive counseling (PCC']","['sexual behavior, drinking expectancy, and incidence of sexually transmitted infections (STIs', 'drinking expectancy', 'condomless receptive anal intercourse', 'Drinking Expectancy', 'drinking expectancy and HIV risk']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",153.0,0.085945,"There was a decline in condomless receptive anal intercourse in the Control (0.74, 95% CI 0.60-0.91; p < 0.01) and PCC arms (0.72, 0.55-0.94; p = 0.02) at 6-month follow-up.","[{'ForeName': 'R Colby', 'Initials': 'RC', 'LastName': 'Passaro', 'Affiliation': 'Department of Emergency Medicine, Los Angeles County + University of Southern California Medical Center, Los Angeles, CA, USA. ryan.c.passaro@vanderbilt.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Chávez-Gomez', 'Affiliation': 'Asociación Civil Via Libre, Lima, Peru.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Castañeda-Huaripata', 'Affiliation': 'Asociación Civil Via Libre, Lima, Peru.'}, {'ForeName': 'Williams', 'Initials': 'W', 'LastName': 'Gonzales-Saavedra', 'Affiliation': 'Asociación Civil Via Libre, Lima, Peru.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Beymer', 'Affiliation': 'Department of Community Health Sciences, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Eddy R', 'Initials': 'ER', 'LastName': 'Segura', 'Affiliation': 'South American Program in HIV Prevention Research, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Nanclares', 'Affiliation': 'Alliance Health Project, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dilley', 'Affiliation': 'Department of Psychiatry, University of California San Francisco School of Medicine, San Francisco, CA, USA.'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Cabello', 'Affiliation': 'Asociación Civil Via Libre, Lima, Peru.'}, {'ForeName': 'Jesse L', 'Initials': 'JL', 'LastName': 'Clark', 'Affiliation': 'South American Program in HIV Prevention Research, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02882-6']
2244,32418174,Effect Evaluation of Strychnos nux-vomica L. with Integrative Methods for Bortezomib-Induced Peripheral Neuropathy in Multiple Myeloma Patients: A Self-Controlled Clinical Trial.,"OBJECTIVE


To explore the clinical effect and adverse reactions of Strychnos nux-vomica in bortezomib-induced peripheral neuropathy (BIPN) of patients with multiple myeloma (MM).
METHODS


A total of 19 MM patients with BIPN were enrolled and Nux Vomica Capsule (NVC, 0.4 g, thrice daily) were orally administrated for 30 days. Comparative analysis on parameters between pre- and post-therapy, including peripheral neuropathy (PN) grade, neurotoxicity score, Chinese medicine (CM) syndrome score, total neuropathy score (TNS), coagulation function, and serum nerve growth factor (NGF) levels were conducted. The adverse events were monitored.
RESULTS


In BIPN of MM patients who received NVC, PN grade was lowered, neurotoxicity score was obviously decreased (P⩽0.01), and both CM syndrome score and TNS were remarkably decreased (P<0.01). After the therapy, activated partial thromboplastin time was prolonged (P<0.01) and fibrinogen was declined (P<0.05), showing improvement in the hypercoagulable state of patients. No significant difference of NGF recovery degrees was detected between pre- and post-therapy (P>0.05). No evident adverse reactions were observed during the course of treatment.
CONCLUSION


Strychnos nux-vomica L. has significantly effect with a good safety in treatment of BIPN in MM patients.",2020,"After the therapy, activated partial thromboplastin time was prolonged (P<0.01) and fibrinogen was declined (P<0.05), showing improvement in the hypercoagulable state of patients.","['19 MM patients with BIPN', 'Multiple Myeloma Patients', 'MM patients', 'patients with multiple myeloma (MM']","['Bortezomib', 'Strychnos nux-vomica in bortezomib', 'Strychnos nux-vomica L']","['CM syndrome score and TNS', 'activated partial thromboplastin time', 'hypercoagulable state', 'peripheral neuropathy (PN) grade, neurotoxicity score, Chinese medicine (CM) syndrome score, total neuropathy score (TNS), coagulation function, and serum nerve growth factor (NGF) levels', 'adverse events', 'neurotoxicity score', 'adverse reactions', 'NGF recovery degrees']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0331071', 'cui_str': 'Strychnos'}, {'cui': 'C0028726', 'cui_str': 'Strychnos nux-vomica'}]","[{'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0045733', 'cui_str': '2-(4-toluidino)-6-naphthalenesulfonic acid'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0398623', 'cui_str': 'Thrombophilia'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4727882', 'cui_str': 'Total neuropathy score'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",,0.0349203,"After the therapy, activated partial thromboplastin time was prolonged (P<0.01) and fibrinogen was declined (P<0.05), showing improvement in the hypercoagulable state of patients.","[{'ForeName': 'Tie-Ying', 'Initials': 'TY', 'LastName': 'Dai', 'Affiliation': 'Department of Hematology, The First Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Hangzhou, 310006, China.'}, {'ForeName': 'Chu-Chu', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, The First Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Hangzhou, 310006, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Hong', 'Affiliation': 'Department of Hematology, The First Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Hangzhou, 310006, China.'}, {'ForeName': 'Hang-Ping', 'Initials': 'HP', 'LastName': 'Ge', 'Affiliation': 'Department of Hematology, The First Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Hangzhou, 310006, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Pei', 'Affiliation': 'Department of Hematology, The First Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Hangzhou, 310006, China.'}, {'ForeName': 'Wen-Qi', 'Initials': 'WQ', 'LastName': 'Lyu', 'Affiliation': 'Department of Hematology, The First Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Hangzhou, 310006, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Hematology, The First Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Hangzhou, 310006, China.'}, {'ForeName': 'Jian-Ping', 'Initials': 'JP', 'LastName': 'Shen', 'Affiliation': 'Department of Hematology, The First Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Hangzhou, 310006, China.'}, {'ForeName': 'Zhi-Ping', 'Initials': 'ZP', 'LastName': 'Hu', 'Affiliation': 'Department of Hematology, The First Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Hangzhou, 310006, China. hzpzy@163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3196-2']
2245,31130165,"Reply to letter to the editor in response to the article ""Communication-based interventions for increasing influenza vaccination rates among Aboriginal children: A randomised controlled trial"".",,2019,,['Aboriginal children'],[],['influenza vaccination rates'],"[{'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}]",,0.0396253,,"[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Borg', 'Affiliation': 'BehaviourWorks Australia, Monash Sustainable Development Institute, Monash University, Melbourne, Australia. Electronic address: kim.borg@monash.edu.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Sutton', 'Affiliation': 'Immunisation Section, Health Protection Branch, Department of Health and Human Services, Victorian State Government, Melbourne, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Beasley', 'Affiliation': 'Immunisation Section, Health Protection Branch, Department of Health and Human Services, Victorian State Government, Melbourne, Australia.'}, {'ForeName': 'Fraser', 'Initials': 'F', 'LastName': 'Tull', 'Affiliation': 'BehaviourWorks Australia, Monash Sustainable Development Institute, Monash University, Melbourne, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Faulkner', 'Affiliation': 'BehaviourWorks Australia, Monash Sustainable Development Institute, Monash University, Melbourne, Australia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Halliday', 'Affiliation': 'Public Sector Innovation, Department of Premier and Cabinet, Victorian State Government, Melbourne, Australia.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Knott', 'Affiliation': 'Behavioural Insights Unit, Department of Premier and Cabinet, Victorian State Government, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bragge', 'Affiliation': 'BehaviourWorks Australia, Monash Sustainable Development Institute, Monash University, Melbourne, Australia.'}]",Vaccine,['10.1016/j.vaccine.2019.05.008']
2246,32418302,A Pilot Non-Inferiority Randomized Controlled Trial to Assess Automatic Adjustments of Insulin Doses in Adolescents with Type 1 Diabetes on Multiple Daily Injections Therapy.,"BACKGROUND


Multiple daily injections (MDI) therapy for type 1 diabetes involves basal and bolus insulin doses. Non-optimal insulin doses contribute to the lack of satisfactory glycemic control. We aimed to evaluate the feasibility of an algorithm that optimizes daily basal and bolus doses using glucose monitoring systems for MDI therapy users.
METHODS


We performed a pilot, non-inferiority, randomized, parallel study at a diabetes camp comparing basal-bolus insulin dose adjustments made by camp physicians (PA) and a learning algorithm (LA), in children and adolescents on MDI therapy. Participants wore a glucose sensor and underwent 11 days of daily dose adjustments in either arm. Algorithm adjustments were reviewed and approved by a physician. The last 7 days were examined for outcomes.
RESULTS


21 youths (age 13.3 (SD, 3.7) years; 13 females; HbA1c 8.6% (SD, 1.8)) were randomized to either group (LA (n = 10) or PA (n = 11)). The algorithm made 293 adjustments with a 92% acceptance rate from the camp physicians. In the last 7 days, the time in target glucose (3.9-10 mmol/L) in LA (39.5%, SD, 20.7) was similar to PA (38.4%, SD, 15.6) (P = 0.89). The number of hypoglycemic events per day in LA (0.3, IQR, [0.1-0.6]) was similar to PA (0.2, IQR, [0.0-0.4]) (P = 0.42). There was no incidence of severe hypoglycemia nor ketoacidosis.
CONCLUSIONS


In this pilot study, glycemic outcomes in the LA group were similar to the PA group. This algorithm has the potential to facilitate MDI therapy, and longer and larger studies are warranted. This article is protected by copyright. All rights reserved.",2020,"There was no incidence of severe hypoglycemia nor ketoacidosis.
","['MDI therapy users', '21 youths (age 13.3 (SD, 3.7) years; 13 females; HbA1c 8.6% (SD, 1.8', 'Adolescents with Type 1 Diabetes on Multiple Daily Injections Therapy', 'children and adolescents on MDI therapy']","['basal-bolus insulin dose adjustments made by camp physicians (PA) and a learning algorithm (LA', 'Multiple daily injections (MDI) therapy']","['glycemic outcomes', 'time in target glucose', 'severe hypoglycemia nor ketoacidosis', 'number of hypoglycemic events']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",293.0,0.0480095,"There was no incidence of severe hypoglycemia nor ketoacidosis.
","[{'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'El Fathi', 'Affiliation': 'Department of Electrical and Computer Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Palisaitis', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'von Oettingen', 'Affiliation': ""Montreal Children's Hospital, Pediatric Endocrinology, Montréal, Canada.""}, {'ForeName': 'Preetha', 'Initials': 'P', 'LastName': 'Krishnamoorthy', 'Affiliation': ""Montreal Children's Hospital, Pediatric Endocrinology, Montréal, Canada.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Legault', 'Affiliation': ""Montreal Children's Hospital, Pediatric Endocrinology, Montréal, Canada.""}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Haidar', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}]",Pediatric diabetes,['10.1111/pedi.13052']
2247,31128221,Estimated legacy effects from simulated post-trial data were less biased than from combined trial/post-trial data.,"OBJECTIVES


""Legacy effects"" describe the phenomena where treatment effects are apparent during the post-trial period that are not attributable to the direct effects observed within the trial. We investigate different approaches to analysis of trial and extended follow-up data for the evaluation of legacy effects.
STUDY DESIGN AND SETTING


We conducted a simulation to compare three approaches, which differed in terms of the time period and selection of trial participants included in the analysis.
RESULTS


The most common approach used for estimating legacy effects in the literature, which combines initial trial and post-trial follow-up data, gave the most biased estimates. Approaches using post-randomized controlled trial data had better performance in most scenarios. When the size of the legacy effect was set to differ according to whether or not drugs were taken after trial, the stratified approach using post-trial data but only from participants taking the drug after trial was less biased but often had lower power to detect a legacy effect.
CONCLUSION


When estimating legacy effects, approaches to analysis that are restricted to post-trial follow-up data are preferred. If data are available on participant drug use after trial, then both stratified and unstratified approaches to analysis of the post-trial data should be investigated.",2019,Approaches using post-RCT data had better performance in most scenarios.,[],[],[],[],[],[],,0.295722,Approaches using post-RCT data had better performance in most scenarios.,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia. Electronic address: Lin.Zhu@uts.edu.au.'}, {'ForeName': 'Katy J L', 'Initials': 'KJL', 'LastName': 'Bell', 'Affiliation': 'Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hayen', 'Affiliation': 'Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.05.010']
2248,29278449,Process evaluation improves delivery of a nutrition-sensitive agriculture programme in Burkina Faso.,"Evidence is emerging from rigorous evaluations about the effectiveness of nutrition-sensitive agriculture programmes in improving nutritional outcomes. Additional evidence can elucidate how different programme components and pathways contribute and can be optimized for impact. The International Food Policy Research Institute, with Helen Keller International, designed a comprehensive framework to evaluate the delivery, utilization, and impact of Helen Keller International's enhanced homestead food production programme in Burkina Faso. After 18 months of implementation, a process evaluation was conducted to examine programme impact pathways, using key informant and semistructured interviews with implementing agents and beneficiaries, and with residents of control communities. Data were analyzed by International Food Policy Research Institute and reviewed with project managers and partners through multiple workshops to identify opportunities to strengthen implementation. Findings illuminated gaps between intended and actual delivery schemes, including input constraints, knowledge gaps among community agents in agriculture and young child nutrition practices, and lower than expected activity by community volunteers. In response, staff developed measures to overcome water constraints and expand vegetable and poultry production, retrained volunteers in certain techniques of food production and counselling for nutrition behaviour change, added small incentives to motivate volunteers, and shaped both immediate and long-term changes to the programme model. Working closely with International Food Policy Research Institute on the evaluation activities also expanded the repertoire of research methods and skills of Helen Keller International staff. Process evaluation can strengthen programme delivery, utilization, and design. Collaboration between researchers and implementers can improve programme effectiveness, project staff capacity, and advance delivery science.",2018,"The International Food Policy Research Institute, with Helen Keller International, designed a comprehensive framework to evaluate the delivery, utilization, and impact of Helen Keller International's enhanced homestead food production programme in Burkina Faso.",['Burkina Faso'],[],[],"[{'cui': 'C0006409', 'cui_str': 'Upper Volta'}]",[],[],,0.0187315,"The International Food Policy Research Institute, with Helen Keller International, designed a comprehensive framework to evaluate the delivery, utilization, and impact of Helen Keller International's enhanced homestead food production programme in Burkina Faso.","[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Nielsen', 'Affiliation': 'Helen Keller International, New York, New York, USA.'}, {'ForeName': 'Deanna K', 'Initials': 'DK', 'LastName': 'Olney', 'Affiliation': 'International Food Policy Research Institute, Washington, D.C., District of Columbia, USA.'}, {'ForeName': 'Marcellin', 'Initials': 'M', 'LastName': 'Ouedraogo', 'Affiliation': 'Helen Keller International, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Pedehombga', 'Affiliation': 'Helen Keller International, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Hippolyte', 'Initials': 'H', 'LastName': 'Rouamba', 'Affiliation': 'Helen Keller International, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Yago-Wienne', 'Affiliation': 'Helen Keller International, Ouagadougou, Burkina Faso.'}]",Maternal & child nutrition,['10.1111/mcn.12573']
2249,32418217,The impact of a modified electronic probe tip design on patient perception of discomfort during periodontal probing using standardised probing force. A randomised controlled trial.,"AIMS


This study evaluated pain associated with electronic probing comparing two commercially available probe tip designs using standardised force.
MATERIAL & METHODS


Twenty adult patients with slight-moderate chronic periodontitis received periodontal probing using controlled-force electronic probe at 2 visits. In visit 1, a random arch was probed with either a ball-end (0.6mm diameter, 408 kPa; Test) or straight (0.45mm diameter, 726 kPa; Control) probe tip. The opposing arch was then probed using the other probe tip. Discomfort associated with each probing episode was recorded using visual analogue scale (VAS). 7 days later, tip assignments were alternated from visit 1 and VAS re-scored. VAS scores were compared by probe tip, arches and visits.
RESULTS


Both tips provided similar VAS scores (median 13.5 for ball-end and 14 for straight, p=0.3713). However, the straight tip was associated with decreased VAS scores in the maxilla (p=0.01). Overall, VAS values did not differ by arch or study visit. Individual VAS scores showed high levels of correlation between study visits and between tips used (R 2  =0.86 and 0.64, respectively, P<0.0001).
CONCLUSIONS


Both probing approaches were associated with low levels of pain on probing. The straight tip, it may be perceived as more comfortable in the maxilla.",2020,"RESULTS


Both tips provided similar VAS scores (median 13.5 for ball-end and 14 for straight, p=0.3713).",['Twenty adult patients with slight-moderate chronic periodontitis received periodontal probing using controlled-force electronic probe at 2 visits'],['modified electronic probe tip design'],"['visual analogue scale (VAS', 'patient perception of discomfort', 'VAS scores', 'Individual VAS scores', 'Overall, VAS values']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2937276', 'cui_str': 'Slight'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0182400', 'cui_str': 'Probe'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",20.0,0.0339407,"RESULTS


Both tips provided similar VAS scores (median 13.5 for ball-end and 14 for straight, p=0.3713).","[{'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Harrison', 'Affiliation': 'Division of Periodontology, University of Florida College of Dentistry, Gainesville, FL, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Stuhr', 'Affiliation': 'Division of Periodontology, University of Florida College of Dentistry, Gainesville, FL, USA.'}, {'ForeName': 'Luciana M', 'Initials': 'LM', 'LastName': 'Shaddox', 'Affiliation': 'Division of Periodontology, University of Florida College of Dentistry, Gainesville, FL, USA.'}]",Journal of clinical periodontology,['10.1111/jcpe.13308']
2250,32418361,"Baseline demographic, clinical, and cognitive characteristics of the Alzheimer's Prevention Initiative (API) Autosomal-Dominant Alzheimer's Disease Colombia Trial.","INTRODUCTION


The API AutosomalDominant AD (ADAD) Colombia Trial is a placebo-controlled clinical trial of crenezumab in 252 cognitively unimpaired 30 to 60-year-old Presenilin 1 (PSEN1) E280A kindred members, including mutation carriers randomized to active treatment or placebo and non-carriers who receive placebo.
METHODS


Of the 252 enrolled, we present data on a total of 242 mutation carriers and non-carriers matched by age range, excluding data on 10 participants to protect participant confidentiality, genetic status, and trial integrity.
RESULTS


We summarize demographic, clinical, cognitive, and behavioral data from 167 mutation carriers and 75 non-carriers, 30 to 53 years of age. Carriers were significantly younger than non-carriers ((mean age ± SD) 37 ± 5 vs 42 ± 6), had significantly lower Mini Mental Status Exam (MMSE) scores (28.8 ± 1.4 vs 29.2 ± 1.0), and had consistently lower memory scores.
DISCUSSION


Although PSEN1 E280A mutation carriers in the Trial are cognitively unimpaired, they have slightly lower MMSE and memory scores than non-carriers. Their demographic characteristics are representative of the local population.",2020,"Carriers were significantly younger than non-carriers ((mean age ± SD) 37 ± 5 vs 42 ± 6), had significantly lower Mini Mental Status Exam (MMSE) scores (28.8 ± 1.4 vs 29.2 ± 1.0), and had consistently lower memory scores.
","['167 mutation carriers and 75 non-carriers, 30 to 53 years of age', '252 cognitively unimpaired 30 to 60-year-old Presenilin 1 (PSEN1', 'Of the 252 enrolled, we present data on a total of 242 mutation carriers and non-carriers matched by age range, excluding data on 10 participants to protect participant confidentiality, genetic status, and trial integrity', 'E280A kindred members, including mutation carriers randomized to active treatment or']","['API AutosomalDominant AD (ADAD', 'placebo and non-carriers who receive placebo', 'crenezumab', 'placebo']",['Mini Mental Status Exam (MMSE) scores'],"[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0299212', 'cui_str': 'Presenilin 1'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002191', 'cui_str': 'alpha 1-Antitrypsin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C3493199', 'cui_str': 'crenezumab'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",252.0,0.37236,"Carriers were significantly younger than non-carriers ((mean age ± SD) 37 ± 5 vs 42 ± 6), had significantly lower Mini Mental Status Exam (MMSE) scores (28.8 ± 1.4 vs 29.2 ± 1.0), and had consistently lower memory scores.
","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Rios-Romenets', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Lopera', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Kaycee M', 'Initials': 'KM', 'LastName': 'Sink', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Qinshu', 'Initials': 'Q', 'LastName': 'Lian', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Guthrie', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Cho', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Mackey', 'Affiliation': 'Genentech Inc., South San Francisco, California, USA.'}, {'ForeName': 'Jessica B', 'Initials': 'JB', 'LastName': 'Langbaum', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Thomas', 'Affiliation': 'University of California, San Diego, California, USA.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Giraldo-Chica', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Tobon', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Acosta-Baena', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Muñoz', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ospina', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Tirado', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Henao', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Yamile', 'Initials': 'Y', 'LastName': 'Bocanegra', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}, {'ForeName': 'Kewei', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Dhruman', 'Initials': 'D', 'LastName': 'Goradia', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Thiyyagura', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'VanGilder', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ghisays', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Malek-Ahmadi', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Hillary D', 'Initials': 'HD', 'LastName': 'Protas', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Yinghua', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Yakeel T', 'Initials': 'YT', 'LastName': 'Quiroz', 'Affiliation': 'Harvard Medical School and Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Reiman', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': 'Pierre N', 'Initials': 'PN', 'LastName': 'Tariot', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, Arizona, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Neurosciences Group of Antioquia/University of Antioquia, Medellin, Colombia.'}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12109']
2251,32418236,Postendodontic pain following occlusal reduction in mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion: a single-centre randomized controlled trial.,"AIM


This randomized, prospective, controlled trial assessed the effect of occlusal reduction on postendodontic pain and medication intake following root canal treatment of mandibular posterior teeth with symptomatic irreversible pulpitis with sensitivity to percussion treated in two visits.
METHODOLOGY


Three hundred and eight patients were randomly assigned into two equal groups according to whether occlusal reduction was done or not (n=154). For all patients, root canal treatment was carried out in two visits without intracanal medication. Patients assessed their pain using the 0-10 numerical rating scale (NRS) 6h, 12h 24h, 48h after the first visit (Postinstrumentation) and 6h and 12h following root canal filling (Postobturation). Patients, also, recorded their medication intake (Sham or analgesic) postinstrumentation and postobturation; patients initially received a sham capsule, but, if pain persisted, an analgesic was prescribed. Data were analysed using Mann-Whitney U-test, Friedman's test, Wilcoxon's rank test and Chi 2  (χ 2  ) test. The Relative Risk (RR) and its 95% confidence interval (CI) were calculated for binary data.
RESULTS


Occlusal reduction was associated with less pain intensity than no occlusal reduction at 12h and 24h postinstrumentation (p<0.05). Pain intensity significantly and gradually decreased with both groups at all postinstrumentation and postobturation timepoints compared to preoperative pain (p<0.05). The RR of moderate-to-severe pain was 0.61 (95% CI: 0.41, 0.91) 12h postinstrumentation and the RR of pain incidence, regardless of its level, was 0.75 (95% CI: 0.61, 0.92) 24h postinstrumentation. There was no significant difference in medication intake (sham or analgesic) between groups (p>0.05).
CONCLUSIONS


Occlusal reduction was effective in reducing the intensity of postoperative pain 12h and 24h after root canal instrumentation in the first visit in patients with symptomatic irreversible pulpitis with sensitivity to percussion. Occlusal reduction lowered the risk of moderate-to-severe pain by about 40% 12h postinstrumentation and the overall risk of pain by 25% 24h postinstrumentation; yet, it did not affect medication intake.",2020,Pain intensity significantly and gradually decreased with both groups at all postinstrumentation and postobturation timepoints compared to preoperative pain (p<0.05).,"['mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion', 'Three hundred and eight patients', 'mandibular posterior teeth with symptomatic irreversible pulpitis with sensitivity to percussion treated in two visits', 'patients with symptomatic irreversible pulpitis with sensitivity to percussion']","['occlusal reduction', 'root canal treatment']","['Postendodontic pain', 'pain intensity', 'postendodontic pain and medication intake', 'Pain intensity', 'Relative Risk (RR) and its 95% confidence interval (CI', 'RR of pain incidence', 'intensity of postoperative pain', 'overall risk of pain', 'RR of moderate-to-severe pain', 'risk of moderate-to-severe pain', 'medication intake']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C4039735', 'cui_str': 'Symptomatic irreversible pulpitis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]",308.0,0.181418,Pain intensity significantly and gradually decreased with both groups at all postinstrumentation and postobturation timepoints compared to preoperative pain (p<0.05).,"[{'ForeName': 'Y E', 'Initials': 'YE', 'LastName': 'Ahmed', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Emara', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Sarhan', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'El Boghdadi', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'M A A', 'Initials': 'MAA', 'LastName': 'El-Bayoumi', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'H M M', 'Initials': 'HMM', 'LastName': 'El-Far', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Sabet', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Abou El-Nasr', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Gawdat', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'S A W', 'Initials': 'SAW', 'LastName': 'Amin', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}]",International endodontic journal,['10.1111/iej.13328']
2252,32418418,Comparison of sirtuin 1 level and related blood factors in diabetic and healthy subjects.,"INTRODUCTION


Diabetes (II) is a chronic metabolic disease with many side effects. Sirtuin 1 (SIRT1) regulates prominent cellular processes such as apoptosis, aging, and metabolism of the cell, and it seems to play an important role in type 2 diabetes.
THE AIM OF THE STUDY


was to compare the serum level of SIRT1 and related biochemical factors in patients with controlled and uncontrolled diabetes with healthy subjects.
METHODS


Type 2 diabetic patients were randomly divided into controlled and uncontrolled fasting blood glucose (FBG) and healthy individuals as the control group (n = 50/group). Serum levels of SIRT1, haemoglobin A1C (HbA1c), low-density lipoprotein (LDL), high-density lipo-protein (HDL), triglyceride (TG), FBG, and body mass index (BMI) were evaluated.
RESULTS


The mean ±SD level of SIRT1 in the uncontrolled diabetic group (3.96 ±2.52) was significantly (p < 0.001) lower than that of the con-trolled diabetic (9.22 ±4.11) and healthy subjects (10.65 ±2.2). The levels of HbA1c, FBG, LDL, HDL, and TG indicated significant differences between the groups (p < 0.05). There was a significant reverse correlation between SIRT1 with HbA1c, FBG, age, and BMI (p < 0.05) and a positive significant correlation between BMI and HbA1c (p = 0.007).
CONCLUSIONS


Sirtuin 1 is associated with improving glucose homeostasis. Therefore, it can be considered as a new therapeutic target for prevention and treatment of type 2 diabetes.",2020,"The levels of HbA1c, FBG, LDL, HDL, and TG indicated significant differences between the groups (p < 0.05).","['diabetic and healthy subjects', 'and healthy individuals as the control group (n = 50/group', 'Type 2 diabetic patients', 'patients with controlled and uncontrolled diabetes with healthy subjects']",['uncontrolled fasting blood glucose (FBG'],"['glucose homeostasis', 'Serum levels of SIRT1, haemoglobin A1C (HbA1c), low-density lipoprotein (LDL), high-density lipo-protein (HDL), triglyceride (TG), FBG, and body mass index', 'levels of HbA1c, FBG, LDL, HDL, and TG', 'mean ±SD level of SIRT1', 'blood factors', 'SIRT1 with HbA1c, FBG, age, and BMI']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0122111', 'cui_str': 'HMGI-C Protein'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",,0.017637,"The levels of HbA1c, FBG, LDL, HDL, and TG indicated significant differences between the groups (p < 0.05).","[{'ForeName': 'Mehrali', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Department of Internal Medicine, Associate Professor of Endocrinology and Metabolism, Kermans-hah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Ghanbari', 'Affiliation': 'Department of Internal Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mozafar', 'Initials': 'M', 'LastName': 'Khazaei', 'Affiliation': 'Fertility and Infertility Research Center, Health Technology Institute, Fertility and Infertility Research Center, Health Technology Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Niroman', 'Affiliation': 'Department of Internal Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]","Pediatric endocrinology, diabetes, and metabolism",['10.5114/pedm.2020.94392']
2253,31107335,CORR Insights®: Tissue Adhesive for Wound Closure Reduces Immediate Postoperative Wound Dressing Changes After Primary TKA: A Randomized Controlled Study in Simultaneous Bilateral TKA.,,2019,,['After Primary TKA'],[],[],"[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]",[],[],,0.0601566,,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Mont', 'Affiliation': 'M. A. Mont, Vice President of Strategic Affairs and Director of Joint Arthroplasty, Lenox Hill Hospital, New York, NY, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000678']
2254,31009140,Assessing the impact of renal artery clamping during laparoscopic partial nephrectomy (LPN) for small renal masses: the rationale and design of the CLamp vs Off Clamp Kidney during LPN (CLOCK II) randomised phase III trial.,,2019,,['small renal masses'],['renal artery clamping during laparoscopic partial nephrectomy (LPN'],[],"[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}]","[{'cui': 'C0035065', 'cui_str': 'Renal Artery'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial excision of kidney'}]",[],,0.0467473,,"[{'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Bove', 'Affiliation': 'Urology Department, San Carlo di Nancy Hospital, Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Bertolo', 'Affiliation': 'Urology Department, San Carlo di Nancy Hospital, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Data Methods and System Statistical Laboratory, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Farullo', 'Affiliation': 'Urology Unit, Department of Surgery, Tor Vergata University of Rome, Rome, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cipriani', 'Affiliation': 'Urology Unit, Department of Surgery, Tor Vergata University of Rome, Rome, Italy.'}, {'ForeName': 'Costantino', 'Initials': 'C', 'LastName': 'Leonardo', 'Affiliation': 'Department of Urology, La Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Parma', 'Affiliation': 'Department of Urology, Ospedale ""Carlo Poma"" Mantova, Mantova, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Falsaperla', 'Affiliation': 'Department of Urology, Vittorio Emanuele Hospital, Catania, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Veneziano', 'Affiliation': 'Department of Urology and Kidney Transplantation, O.O. Riuniti BMM, Reggio Calabria, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Celia', 'Affiliation': 'Department of Urology, San Bassiano Hospital, Bassano Del Grappa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Minervini', 'Affiliation': 'Department of Urology, Careggi Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Antonelli', 'Affiliation': 'Unit of Urology, Spedali Civili Hospital, University of Brescia, Brescia, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJU international,['10.1111/bju.14779']
2255,31144282,Communicating a Prognosis: a Randomized Trial of Survival Rate Language.,,2019,,[],[],[],[],[],[],,0.121896,,"[{'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Silver', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Broomell', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Davis', 'Affiliation': 'Department of Engineering and Public Policy, Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'Departments of Medicine and Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Krishnamurti', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA. tamark@pitt.edu.'}]",Journal of general internal medicine,['10.1007/s11606-019-05056-w']
2256,32418538,The impact of a cartoon character on adults perceptions of Children's breakfast cereals: a randomized experiment.,"BACKGROUND


Cartoon characters on processed food packaging increase the perception of product preference among children, but their effect among adults has rarely been examined. We evaluated the effect of a cartoon character on breakfast cereals on beliefs about buying them for children, as well as whether demographic characteristics modified this effect.
METHODS


An experimental study was conducted with adults from online consumer panels in Mexico (n = 3755). Participants were randomly assigned to a ""cartoon"" condition (n = 1789), in which they viewed a breakfast cereal box with a Minion character on the front of the package, or the ""control"" condition (n = 1966), in which the same cereal box was displayed with no character on the package. Participants were asked: ""Is this a good cereal to buy children?"" with the response options ""Yes"", ""No"", or ""Don't know"". Multinomial adjusted logistic models regressed responses to this question (Yes = 0, No = 1, 2 = Don't know) on experimental condition. Differences in the effect of the cartoon character across demographic characteristics were tested by introducing multiplicative interaction terms.
RESULTS


The adjusted model showed that participants in the ""cartoon character"" condition were 1.67 (1.45-1.94) times more likely to consider the cereal as being ""Not good to buy for children"" than those in the control condition (p < 0.001). This effect was smaller among parents (RRR = 1.39, 1.13-1.72) compared to those without children (RRR = 2.01, 1.63-2.47). No differences were observed in the proportion of participants answering ""Don't know"" across experimental groups.
CONCLUSION


Among this sample of Mexican adults, a cereal with a cartoon character on the packaging was more often perceived as ""not good to buy for children"" compared to a cereal without it. This effect was smaller among parents, potentially due to children influences of parental decisions during food purchasing.",2020,"No differences were observed in the proportion of participants answering ""Don't know"" across experimental groups.
","[""adults perceptions of Children's breakfast cereals"", 'adults from online consumer panels in Mexico (n\u2009=\u20093755']","['cartoon"" condition (n\u2009=\u20091789), in which they viewed a breakfast cereal box with a Minion character on the front of the package, or the ""control"" condition', 'cartoon character', 'cartoon character on breakfast cereals']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}]","[{'cui': 'C0007306', 'cui_str': 'Cartoons'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0482463,"No differences were observed in the proportion of participants answering ""Don't know"" across experimental groups.
","[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Contreras-Manzano', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Jáuregui', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico. alejandra.jauregui@insp.mx.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Nieto', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Vargas-Meza', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Thrasher', 'Affiliation': 'Population Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col. Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Illescas-Zárate', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'Simón', 'Initials': 'S', 'LastName': 'Barquera', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col, Santa María Ahuacatitlán, 62100, Cuernavaca, Mexico.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Demography, ANU College of Arts and Social Sciences, The Australian National University, 9 Fellows Road Acton ACT, Canberra, 260, Australia.'}]",Nutrition journal,['10.1186/s12937-020-00565-5']
2257,32418546,Effect of the monoaminergic stabiliser (-)-OSU6162 on mental fatigue following stroke or traumatic brain injury.,"OBJECTIVE


The purpose of the present study was to evaluate the efficacy and safety of (-)-OSU6162 in doses up to 30 mg b.i.d. in patients suffering from mental fatigue following stroke or traumatic brain injury (TBI).
METHODS


This 4+4 weeks double blind randomised cross-over study included 30 patients afflicted with mental fatigue following a stroke or head trauma occurring at least twelve months earlier. Efficacy was assessed using the Mental Fatigue Scale (MFS), the Self-rating Scale for Affective Syndromes (CPRS), the Frenchay Activity Index (FAI), and a battery of neuropsychological tests. Safety was evaluated by recording spontaneously reported adverse events.
RESULTS


There were significant differences on the patients' total FAI scores (p=0.0097), the subscale FAI outdoor scores (p=0.0243), and on the trail making test (TMT-B) (p=0.0325) in favour of (-)-OSU6162 treatment. Principal component analysis showed a clear overall positive treatment effect in 10 of 28 patients; those who responded best to treatment had their greatest improvements on the MFS. Reported adverse events were mild or moderate in severity and did not differ between the (-)-OSU6162 and the placebo period.
CONCLUSION


The most obvious beneficial effects of (-)-OSU6162 was on the patients' activity level, illustrated by the improvement on the FAI scale. Moreover, a subgroup of patients showed substantial improvements on the Mental Fatigue Scale. Based on these observed therapeutic effects, in conjunction with the good tolerability of (-)-OSU6162, this compound may offer promise for treating at least part of the symptomatology in patients suffering from stroke- or TBI-induced mental fatigue.",2020,"There were significant differences on the patients' total FAI scores (p=0.0097), the subscale FAI outdoor scores (p=0.0243), and on the trail making test (TMT-B) (p=0.0325) in favour of (-)-OSU6162 treatment.","['patients suffering from stroke- or TBI-induced mental fatigue', '30 patients afflicted with mental fatigue following a stroke or head trauma occurring at least twelve months earlier', 'mental fatigue following stroke or traumatic brain injury', 'patients suffering from mental fatigue following stroke or traumatic brain injury (TBI']",['monoaminergic stabiliser (-)-OSU6162'],"['Mental Fatigue Scale', 'Safety', 'MFS', 'subscale FAI outdoor scores', 'efficacy and safety', 'Efficacy', 'adverse events', ""patients' total FAI scores"", 'Mental Fatigue Scale (MFS), the Self-rating Scale for Affective Syndromes (CPRS), the Frenchay Activity Index (FAI), and a battery of neuropsychological tests', 'FAI scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018674', 'cui_str': 'Injury of head'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0966482', 'cui_str': '(-)-OSU6162'}]","[{'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}]",30.0,0.0501934,"There were significant differences on the patients' total FAI scores (p=0.0097), the subscale FAI outdoor scores (p=0.0243), and on the trail making test (TMT-B) (p=0.0325) in favour of (-)-OSU6162 treatment.","[{'ForeName': 'Marie Kl', 'Initials': 'MK', 'LastName': 'Nilsson', 'Affiliation': 'Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Johansson', 'Affiliation': 'Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Carlsson', 'Affiliation': 'Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Schuit', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location VUmc, Amsterdam, The Nederlands.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rönnbäck', 'Affiliation': 'Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Acta neuropsychiatrica,['10.1017/neu.2020.22']
2258,31152865,Contacting authors by telephone increased response proportions compared with emailing: results of a randomized study.,"OBJECTIVE


The aim of the study was to compare response proportions and research costs of telephone calling vs. continued emailing nonresponding authors of studies included in a systematic review.
STUDY DESIGN AND SETTING


Key features of included studies were poorly reported in a systematic review of diabetes quality improvement interventions. We developed a survey to request additional information from contact authors. After three email contact attempts, only 76 of 279 authors (27%) had completed the survey. In this study, we randomly assigned nonresponding authors to contact by telephone calling vs. continued emailing to compare the effect of these strategies on response proportions and research costs.
RESULTS


We randomized 87 authors to telephone and 89 to email contact. Telephone contact increased survey completion (36.7% vs. 20.2%; adjusted risk difference of 15.6% [95% confidence interval: 2.90%, 28.4%]; adjusted odds ratio 2.26 [95% confidence interval: 1.10, 4.76]) but required more time to deliver (20 vs. 10 hours in total; 14 vs. 7 minutes per randomized author; 26 vs. 4 weeks), and cost more (total intervention cost of $504 Canadian dollars vs. $252 for the telephone and email arm, respectively).
CONCLUSION


Contacting nonresponding authors of included studies by telephone increased response compared with emailing but required more investigator time and had higher cost.",2019,"Telephone contact increased survey completion (36.7% vs. 20.2%; adjusted risk difference of 15.6% [95% CI: 2.90%, 28.4%]",[],[],['survey completion'],[],[],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}]",87.0,0.308032,"Telephone contact increased survey completion (36.7% vs. 20.2%; adjusted risk difference of 15.6% [95% CI: 2.90%, 28.4%]","[{'ForeName': 'Kristin J', 'Initials': 'KJ', 'LastName': 'Danko', 'Affiliation': 'Center for Evidence Synthesis in Health, School of Public Health, Brown University, Providence, RI, USA; Department of Health Services, Policy & Practice, School of Public Health, Brown University, Providence, RI, USA. Electronic address: kristin_danko@brown.edu.'}, {'ForeName': 'Issa J', 'Initials': 'IJ', 'LastName': 'Dahabreh', 'Affiliation': 'Center for Evidence Synthesis in Health, School of Public Health, Brown University, Providence, RI, USA; Department of Health Services, Policy & Practice, School of Public Health, Brown University, Providence, RI, USA; Department of Epidemiology, School of Public Health, Brown University, Providence, RI, USA.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Ivers', 'Affiliation': ""Family Practice Health Centre, Women's College Research Institute, Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada; Department of Family and Community Medicine, Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moher', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada; Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.05.027']
2259,32420450,Orthokeratology with increased compression factor (OKIC): study design and preliminary results.,"Objective


To present the study design and the baseline data of a prospective cohort study investigating the safety, refractive correction and effectiveness of myopia control in subjects fitted with orthokeratology (ortho-k) lenses of different compression factors.
Methods and analysis


This study is a 2-year longitudinal, double-masked, partially randomised study. Myopic children aged between 6 and 10 years are recruited and they may choose to participate in either the ortho-k or spectacle-wearing group. Subjects in the ortho-k group are randomly assigned to wear ortho-k lenses of either conventional compression factor (CCF, 0.75 D) or increased compression factor (ICF, 1.75 D). For the ortho-k subjects, the time and between-group effects within the first month of lens wear were analysed.
Results


Sixty-nine ortho-k subjects (CCF: 34; ICF: 35) and 30 control subjects were recruited. There were no significant differences in baseline demographic data among the three groups of subjects (p>0.19). At the 1-month visit, the first fit success rates were 97% and 100% in the CCF and ICF ortho-k group, respectively. A higher percentage of ICF subjects could achieve full correction (CCF: 88.2%; ICF: 94.3%). The change in axial length was significantly higher in the ICF group (CCF, 0.003 mm; ICF, -0.031 mm) (p<0.05). No significant between-group differences in daytime vision or in the coverage and depth of corneal staining between the two ortho-k groups (p>0.05) were observed at any visit.
Conclusion


ICF did not compromise the corneal integrity and the lens centration within the first month of lens wear. The preliminary performance of ortho-k lenses with ICF of 1.00D shows that it was safe to be used in the longer term for the investigation of myopia control.
Trial registration number


NCT02643342.",2020,"No significant between-group differences in daytime vision or in the coverage and depth of corneal staining between the two ortho-k groups (p>0.05) were observed at any visit.
","['subjects fitted with orthokeratology (ortho-k) lenses of different compression factors', '30 control subjects were recruited', 'Myopic children aged between 6 and 10 years are recruited and they may choose to participate in either the ortho-k or spectacle-wearing group']","['myopia control', 'ICF', 'wear ortho-k lenses of either conventional compression factor (CCF, 0.75 D) or increased compression factor (ICF, 1.75 D']","['daytime vision', 'coverage and depth of corneal staining', 'corneal integrity and the lens centration', 'baseline demographic data', 'success rates', 'change in axial length']","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4517514', 'cui_str': '1.75'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",,0.0627344,"No significant between-group differences in daytime vision or in the coverage and depth of corneal staining between the two ortho-k groups (p>0.05) were observed at any visit.
","[{'ForeName': 'Kin', 'Initials': 'K', 'LastName': 'Wan', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Jason Ki-Kit', 'Initials': 'JK', 'LastName': 'Lau', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Sin Wan', 'Initials': 'SW', 'LastName': 'Cheung', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Cho', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Hong Kong, China.'}]",BMJ open ophthalmology,['10.1136/bmjophth-2019-000345']
2260,25786348,Relationship of newborn weight loss to milk supply concern and anxiety: the impact on breastfeeding duration.,"Milk supply concern is the most common reason for breastfeeding discontinuation and maternal anxiety is also associated with reduced breastfeeding duration. Newborn excess weight loss (EWL) could trigger milk supply concern and anxiety and might be amenable to modification. Our objective was to determine the relationship between EWL and the development of milk supply concern and anxiety and the effect of such development on breastfeeding duration. We conducted a cohort analysis using data previously obtained from a randomised controlled trial comparing two post-hospital discharge follow-up strategies. For 1107 well, singleton infants born at ≥34 weeks, we extracted data on all inpatient infant weights. EWL was defined as the loss of ≥10% of birthweight. We surveyed mothers to obtain data on state anxiety and milk supply concern at birth and at 2 weeks. Our final outcome was breastfeeding at 6 months. Seventy (6.3%) infants developed EWL during the birth hospitalisation. At 2 weeks, milk supply concern and positive anxiety screen were more common (42% and 18%, respectively) among mothers whose infants had had EWL than among mothers whose infants had not had EWL (20% and 6%, respectively) (P < 0.001 for each comparison). Mothers with milk supply concern at 2 weeks were much less likely to be breastfeeding at 6 months, with odds ratio of 0.47 (0.30, 0.74) in multivariate analysis. EWL may increase milk supply concern and anxiety and these may reduce breastfeeding duration. Ameliorating EWL might alleviate milk supply concern and anxiety and improve breastfeeding duration.",2016,"At 2 weeks, milk supply concern and positive anxiety screen were more common (42% and 18%, respectively) among mothers whose infants had had EWL than among mothers whose infants had not had EWL (20% and 6%, respectively)","['For 1107 well, singleton infants born at ≥34 weeks, we extracted data on all inpatient infant weights']",[],"['milk supply concern and anxiety', 'milk supply concern and positive anxiety screen']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",[],"[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",,0.0636758,"At 2 weeks, milk supply concern and positive anxiety screen were more common (42% and 18%, respectively) among mothers whose infants had had EWL than among mothers whose infants had not had EWL (20% and 6%, respectively)","[{'ForeName': 'Valerie J', 'Initials': 'VJ', 'LastName': 'Flaherman', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of California, San Francisco, California, USA.'}, {'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Beiler', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Cabana', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of California, San Francisco, California, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Paul', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12171']
2261,32418547,Consuming decaffeinated coffee with milk and sugar added before a high glycaemic index meal improves postprandial glycaemic and insulinaemic responses in healthy adults.,"This study aimed to compare the effects of drinking different types of coffee before a high glycaemic index (GI) meal on postprandial glucose metabolism and to assess the effects of adding milk and sugar into coffee. In this randomised, crossover acute feeding study, apparently healthy adults (n = 21) consumed the test drink followed by a high GI meal in each session. Different types of coffee (espresso, instant, boil, and decaffeinated, all with milk and sugar) and plain water were tested in separate sessions, while a subset of the participants (n = 10) completed extra sessions using black coffees. Postprandial levels of glucose, insulin, active glucagon-like peptide 1 (GLP-1), and nitrotyrosine between different test drinks were compared using linear mixed models. Results showed that only preloading decaffeinated coffee with milk and sugar led to significantly lower glucose incremental area-under-curves (iAUCs; 14% lower, p = 0.001) than water. Preloading black coffees led to greater postprandial glucose iAUCs than preloading coffees with milk and sugar added (12 - 35% smaller, p < 0.05 for all coffee types). Active GLP-1 and nitrotyrosine levels were not significantly different between test drinks. To conclude, preloading decaffeinated coffee with milk and sugar led to a blunted postprandial glycaemic response after a subsequent, high GI meal, while adding milk and sugar into coffee could mitigate the impairment effect of black coffee towards postprandial glucose responses. These findings may partly explain the positive effects of coffee consumption on glucose metabolism.",2020,"Postprandial levels of glucose, insulin, active glucagon-like peptide 1 (GLP-1), and nitrotyrosine between different test drinks were compared using linear mixed models.","['healthy adults', 'apparently healthy adults (n = 21']","['Consuming decaffeinated coffee with milk and sugar added before a high glycaemic index meal', 'preloading decaffeinated coffee with milk and sugar', 'drinking different types of coffee before a high glycaemic index (GI) meal', 'consumed the test drink followed by a high GI meal', 'coffee (espresso, instant, boil, and decaffeinated, all with milk and sugar) and plain water']","['postprandial glycaemic response', 'postprandial glucose metabolism', 'glucose incremental area-under-curves', 'postprandial glycaemic and insulinaemic responses', 'Postprandial levels of glucose, insulin, active glucagon-like peptide 1 (GLP-1), and nitrotyrosine between different test drinks', 'postprandial glucose responses', 'postprandial glucose iAUCs', 'glucose metabolism', 'Active GLP-1 and nitrotyrosine levels']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0452434', 'cui_str': 'Coffee with milk and sugar'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0242301', 'cui_str': 'Furuncle'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0047645', 'cui_str': '3-nitrotyrosine'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]",21.0,0.0270596,"Postprandial levels of glucose, insulin, active glucagon-like peptide 1 (GLP-1), and nitrotyrosine between different test drinks were compared using linear mixed models.","[{'ForeName': 'Tommy H T', 'Initials': 'THT', 'LastName': 'Wong', 'Affiliation': 'School of Biological Sciences, University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Jennifer M F', 'Initials': 'JMF', 'LastName': 'Wan', 'Affiliation': 'School of Biological Sciences, University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Iris M Y', 'Initials': 'IMY', 'LastName': 'Tse', 'Affiliation': 'School of Biological Sciences, University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Sit', 'Affiliation': 'School of Biological Sciences, University of Hong Kong, Hong Kong Special Administrative Region.'}, {'ForeName': 'Jimmy C Y', 'Initials': 'JCY', 'LastName': 'Louie', 'Affiliation': 'School of Biological Sciences, University of Hong Kong, Hong Kong Special Administrative Region.'}]",The British journal of nutrition,['10.1017/S0007114520001750']
2262,32420402,Recurrence of  Plasmodium malariae  and  P. falciparum  Following Treatment of Uncomplicated Malaria in North Sumatera With Dihydroartemisinin-Piperaquine or Artemether-Lumefantrine.,"Background


We assessed the efficacy of artemisinin-based combination therapies for treatment of uncomplicated  falciparum  malaria, with or without co-infecting  Plasmodium  spp., in Sumatera, Indonesia.
Methods


Febrile patients aged >6 months with uncomplicated  P. falciparum  were randomized to receive dihydroartemisinin-piperaquine or artemether-lumefantrine, plus single-dose primaquine, and were followed for 42 days. Mixed  Plasmodium  infections were included;  P. vivax  infections received 14 days of primaquine. We retrospectively restricted the analysis to cases with polymerase chain reaction (PCR)-confirmed parasitemia. Recurrent parasitemia in follow-up was identified by species-specific nested PCR.
Results


Of the 3731 participants screened, 302 were enrolled and randomized. In the dihydroartemisinin-piperaquine arm,  P. falciparum  infections were confirmed by PCR in 59 participants, with mixed infections in 23 (39.0%). In the artemether-lumefantrine arm,  P. falciparum  infections were confirmed by PCR in 55 participants, with mixed infections in 16 (29.0%). Both regimens were well tolerated, and symptoms improved rapidly in all treated participants. In the dihydroartemisinin-piperaquine arm, 1  P. falciparum  recurrence (on day 7) and 6  P. malariae  recurrences (1 had a mixed infection with  P. falciparum ) were identified during days 3-42 of follow-up. In the artemether-lumefantrine arm, 1  P. falciparum/P. malariae/P. vivax  recurrence occurred on day 35. Submicroscopic persistence occurred during follow-up in 21 (37%) of 57 receiving dihydroartemisinin-piperaquine and 20 (39%) of 51 receiving artemether-lumefantrine.
Conclusions


In Sumatera, both regimens effectively cleared initial parasitemia, but  P. falciparum  and  P. malariae  persisted in some individuals. Molecular species detection should be deployed in antimalarial efficacy trials in Indonesia.
Trial registration


NCT02325180.",2020,"Submicroscopic persistence occurred during follow-up in 21 (37%) of 57 receiving dihydroartemisinin-piperaquine and 20 (39%) of 51 receiving artemether-lumefantrine.
","['uncomplicated  falciparum  malaria, with or without co-infecting  Plasmodium  spp', 'Methods\n\n\nFebrile patients aged >6 months with uncomplicated  P. falciparum', 'Uncomplicated Malaria in North Sumatera', '3731 participants screened, 302 were enrolled and randomized']","['artemisinin-based combination therapies', 'dihydroartemisinin-piperaquine or artemether-lumefantrine, plus single-dose primaquine', 'primaquine', 'Dihydroartemisinin-Piperaquine or Artemether-Lumefantrine']","['Recurrent parasitemia', 'Submicroscopic persistence', 'tolerated, and symptoms']","[{'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0024535', 'cui_str': 'Falciparum malaria'}, {'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0205805', 'cui_str': 'Sumatera'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0033126', 'cui_str': 'Primaquine'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",302.0,0.186644,"Submicroscopic persistence occurred during follow-up in 21 (37%) of 57 receiving dihydroartemisinin-piperaquine and 20 (39%) of 51 receiving artemether-lumefantrine.
","[{'ForeName': 'Inke Nadia D', 'Initials': 'IND', 'LastName': 'Lubis', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Universitas Sumatera Utara, Medan, Indonesia.'}, {'ForeName': 'Hendri', 'Initials': 'H', 'LastName': 'Wijaya', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Universitas Sumatera Utara, Medan, Indonesia.'}, {'ForeName': 'Munar', 'Initials': 'M', 'LastName': 'Lubis', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Universitas Sumatera Utara, Medan, Indonesia.'}, {'ForeName': 'Chairuddin P', 'Initials': 'CP', 'LastName': 'Lubis', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, Universitas Sumatera Utara, Medan, Indonesia.'}, {'ForeName': 'Khalid B', 'Initials': 'KB', 'LastName': 'Beshir', 'Affiliation': 'Infection and Immunity Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sarah G', 'Initials': 'SG', 'LastName': 'Staedke', 'Affiliation': 'Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Sutherland', 'Affiliation': 'Infection and Immunity Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa116']
2263,32420511,Study within a trial (SWAT) protocol. Investigating the effect of personalised versus non-personalised study invitations on recruitment: An embedded randomised controlled recruitment trial.,"Introduction


Recruitment into clinical trials is a common challenge experienced by healthcare researchers. Currently, there is little evidence regarding strategies to improve recruitment into clinical trials. However, preliminary research suggests the personalisation of study invitation letters may increase recruitment rates. As such, there is a need to investigate the effectiveness of personalisation strategies on trial recruitment rates. This study within a trial (SWAT) will investigate the effect of personalised versus non-personalised study invitation letters on recruitment rates into the host trial ENGAGE, a feasibility study of an internet-administered, guided, Cognitive-Behavioural Therapy (CBT) based self-help intervention for parents of children previously treated for cancer.
Methods


An embedded randomised controlled trial (RCT) will investigate the effectiveness of a personalised study invitation letter including the potential participant's name and address compared with a standard, non-personalised letter without name or address, on participant recruitment rates into the ENGAGE study. The primary outcome is differences in the proportion of participants recruited, examined using logistic regression. Results will be reported as adjusted odds ratios with 95% confidence intervals.
Discussion


Even moderate effects of the personalisation of study invitation letters on recruitment rates could be of significant value by shortening study length, saving resources, and providing a faster answer to the clinical question posed by the study. This protocol can be used as a template for other researchers who wish to contribute to the evidence base for trial decision-making, by embedding a similar SWAT into their trial.
Trial registration


ISRCTN 57233429; ISRCTN 18404129; SWAT 112, Northern Ireland Hub for Trials Methodology Research SWAT repository (2018 OCT 1 1231).",2020,"Even moderate effects of the personalisation of study invitation letters on recruitment rates could be of significant value by shortening study length, saving resources, and providing a faster answer to the clinical question posed by the study.",['parents of children previously treated for cancer'],"['personalised versus non-personalised study invitation letters', 'internet-administered, guided, Cognitive-Behavioural Therapy (CBT) based self-help intervention', 'personalised versus non-personalised study invitations']",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.298338,"Even moderate effects of the personalisation of study invitation letters on recruitment rates could be of significant value by shortening study length, saving resources, and providing a faster answer to the clinical question posed by the study.","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Woodford', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.""}, {'ForeName': 'Kajsa', 'Initials': 'K', 'LastName': 'Norbäck', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.""}, {'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Hagström', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Grönqvist', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.""}, {'ForeName': 'Adwoa', 'Initials': 'A', 'LastName': 'Parker', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, York Trials Unit, University of York, United Kingdom.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arundel', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, York Trials Unit, University of York, United Kingdom.'}, {'ForeName': 'Louise von', 'Initials': 'LV', 'LastName': 'Essen', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.""}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100572']
2264,32009067,Nerve Block for Pain Relief During Arthroscopic Rotator Cuff Repair.,"BACKGROUND


Although arthroscopic rotator cuff repair (ARCR) often results in good outcomes, some patients have severe pain postoperatively. This study investigated the efficacy of nerve block for ARCR.
METHODS


This study was retrospective, and consent was obtained from all patients. We divided 50 patients who had undergone ARCR into 4 groups: continuous interscalene nerve block was performed for 11 patients (continuous-injection group), single interscalene nerve block for 10 (single-injection group), suprascapular nerve block for 8 (suprascapular group), and intravenous analgesic administration for 10 (intravenous group). Eleven patients received no nerve block (control group). We evaluated diclofenac sodium and pentazocine dosing, visual analog scale (VAS) scores, and perioperative complications in each group. VAS scoring was done immediately after surgery and 1 and 6 hours and 1, 2, 3, 7, and 14 days postoperatively.
RESULTS


The doses of diclofenac sodium and pentazocine did not differ between groups. VAS scores immediately after surgery and at 1 and 6 hours after surgery were significantly lower in the single-injection and continuous-injection groups than in the suprascapular, intravenous, and control groups. VAS score at 1 day postoperatively was significantly lower in the continuous-injection group than in the other groups. One patient in the continuous group reported temporary paralysis of the fingers and drug solution leakage.
CONCLUSION


Interscalene nerve blocks yielded good pain relief for ARCR. Although continuous interscalene nerve block produced continuous pain relief, complications are a concern.",2020,"VAS scores immediately after surgery and at 1 and 6 hours after surgery were significantly lower in the single-injection and continuous-injection groups than in the suprascapular, intravenous, and control groups.","['50 patients who had undergone ARCR into 4 groups', 'Eleven patients received no nerve block (control group']","['continuous interscalene nerve block', 'Arthroscopic Rotator Cuff Repair', 'arthroscopic rotator cuff repair (ARCR', 'diclofenac sodium and pentazocine', 'single interscalene nerve block for 10 (single-injection group), suprascapular nerve block for 8 (suprascapular group), and intravenous analgesic administration']","['VAS score', 'pain relief', 'VAS scoring', 'visual analog scale (VAS) scores, and perioperative complications', 'Pain Relief', 'temporary paralysis of the fingers and drug solution leakage', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0030873', 'cui_str': 'Pentazocine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0237766', 'cui_str': 'Hysterical paralysis'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0525069', 'cui_str': 'Solutions, Pharmaceutical'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",50.0,0.0424883,"VAS scores immediately after surgery and at 1 and 6 hours after surgery were significantly lower in the single-injection and continuous-injection groups than in the suprascapular, intravenous, and control groups.","[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Iwashita', 'Affiliation': 'Department of Orthopaedic Surgery, Nippon Medical School Hospital.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hashiguchi', 'Affiliation': 'Department of Orthopaedic Surgery, Nippon Medical School Hospital.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Okubo', 'Affiliation': 'Department of Orthopaedic Surgery, Nippon Medical School Hospital.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Yoneda', 'Affiliation': 'Department of Orthopaedic Surgery, Nippon Medical School Hospital.'}, {'ForeName': 'Shinro', 'Initials': 'S', 'LastName': 'Takai', 'Affiliation': 'Department of Orthopaedic Surgery, Nippon Medical School Hospital.'}]",Journal of Nippon Medical School = Nippon Ika Daigaku zasshi,['10.1272/jnms.JNMS.2020_87-206']
2265,32420337,The Effectiveness of Peer Group-Based Training on the Outcomes of Patients Undergoing Transradial Coronary Angiography.,"Introduction


Coronary artery angiography using radial artery is one of the methods used for diagnosis of coronary artery disease, which causes physical and psychological problems in patients despite its precise and definite diagnosis. The present study is aimed at investigating the effect of peer group-based education on physical and psychological outcomes of patients undergoing coronary artery angiography through the radial artery.  Methodology . The present clinical study was conducted on 60 patients undergoing coronary angiography through the radial artery in Vali-e-Asr educational hospital of Fasa during 2018 to 2019. The participants were divided into peer training and control groups ( n  = 30 in each group) using permutated block randomization. In the peer training group, the patients received the necessary precare training through peer training during and after angiography care. In the control group, the patients received the routine care by the nurse of the related ward. The peer group's stress, anxiety, and depression levels were evaluated before and after the training. Indeed, their comfort, tolerance, satisfaction, and pain levels were measured by a nurse after angiography at the time of entering the ward.  Findings . The results indicated no significant difference between the two groups regarding the mean scores of stress, anxiety, and depression before the intervention ( p  > 0.05). After the intervention, however, there was a significant difference between the two groups concerning the mean score of anxiety ( p  < 0.05). Nonetheless, no significant difference was found between the two groups in terms of tolerance, comfort, satisfaction, and pain levels ( p  > 0.05). Finally, the level of pain decreased in both groups over time ( p  < 0.001).
Conclusion


Peer group-based training was effective in decreasing the mean score of anxiety in the patients undergoing coronary angiography. Thus, this method is recommended to be utilized alongside other methods to train patients before coronary angiography due to its inexpensiveness and lack of side effects as well as not increasing the nurses' workload.",2020,"Nonetheless, no significant difference was found between the two groups in terms of tolerance, comfort, satisfaction, and pain levels ( p  > 0.05).","['60 patients undergoing coronary angiography through the radial artery in Vali-e-Asr educational hospital of Fasa during 2018 to 2019', 'patients undergoing coronary artery angiography through the radial artery', 'Patients Undergoing Transradial Coronary Angiography', 'patients undergoing coronary angiography']","['Peer Group-Based Training', 'peer group-based education', 'necessary precare training through peer training during and after angiography care']","['stress, anxiety, and depression levels', 'comfort, tolerance, satisfaction, and pain levels', 'mean score of anxiety', 'level of pain', 'mean scores of stress, anxiety, and depression', 'tolerance, comfort, satisfaction, and pain levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",60.0,0.0201893,"Nonetheless, no significant difference was found between the two groups in terms of tolerance, comfort, satisfaction, and pain levels ( p  > 0.05).","[{'ForeName': 'Ahmad Reza', 'Initials': 'AR', 'LastName': 'Dehghan', 'Affiliation': 'Fasa University of Medical Sciences, Fasa, Iran.'}, {'ForeName': 'Zhila', 'Initials': 'Z', 'LastName': 'Fereidouni', 'Affiliation': 'Fasa University of Medical Sciences, Fasa, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Najafi Kalyani', 'Affiliation': 'School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",BioMed research international,['10.1155/2020/3629782']
2266,32420391,Comparison of Intravenous Regional Anesthesia with Single-Cuff Forearm Tourniquet and Hematoma Block and Traditional Method in Patients with Distal Radius Fractures; A Randomized Clinical Trial.,"Objective


To investigate the effect of intravenous regional anesthesia with single-cuff forearm tourniquet and hematoma block on intraoperative and postoperative pain intensity of patients with distal radial bone fracture.
Methods


In this randomized clinical trial, a total number of 52 patients with distal radius fractures were randomly assigned to receive either a traditional Bier block with 3 mg.kg -1  lidocaine (D group) or a single-cuff forearm tourniquet intravenous regional anesthesia with 1.5 mg.kg -1  lidocaine and a hematoma block with 10 mL 0.5% bupivacaine (S group). Pain intensity score of  numerical rating scale (NRS)  was measured hourly for 6 hours, then every two hours till 12 th  hour and every 4 hours until 24 th  postoperative hour. Total morphine consumption in the first 24 hours after surgery, its side effects and the patients' global satisfaction were assessed in each group.
Results


Mean total morphine consumption during the first 24 hours after surgery was 11.68±7.88 mg in group D and 7.12±4.42 mg in group S ( p =0.13). Pain intensity score of NRS both during recovery room and surgical ward stay was less in S group compared to D group (0.016 and 0.02, respectively).
Conclusion


Intravenous regional anesthesia with single cuff forearm tourniquet and hematoma block compared to the traditional Bier block reduced intraoperative and postoperative pain intensity more effectively in patients with distal fracture of the radius bone and also reduced morphine consumption during the first 24 hours after surgery.",2020,"Pain intensity score of NRS both during recovery room and surgical ward stay was less in S group compared to D group (0.016 and 0.02, respectively).
","['52 patients with distal radius fractures', 'Patients with Distal Radius Fractures', 'patients with distal fracture of the radius bone', 'patients with distal radial bone fracture']","['intravenous regional anesthesia with single-cuff forearm tourniquet and hematoma block', 'Intravenous Regional Anesthesia with Single-Cuff Forearm Tourniquet and Hematoma Block and Traditional Method', 'traditional Bier block with 3 mg.kg -1  lidocaine (D group) or a single-cuff forearm tourniquet intravenous regional anesthesia with 1.5 mg.kg -1  lidocaine and a hematoma block with 10 mL 0.5% bupivacaine']","['Total morphine consumption', 'Pain intensity score of NRS both during recovery room and surgical ward stay', 'morphine consumption', 'Mean total morphine consumption', 'Pain intensity score of  numerical rating scale (NRS', 'global satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0472452', 'cui_str': 'Fracture infiltration with local anesthetic'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0580806', 'cui_str': 'Local anesthetic intravenous regional block'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",52.0,0.113144,"Pain intensity score of NRS both during recovery room and surgical ward stay was less in S group compared to D group (0.016 and 0.02, respectively).
","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Farbood', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Khademi', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tajvidi', 'Affiliation': 'Department of Anesthesiology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Minoo', 'Initials': 'M', 'LastName': 'Hooshangi', 'Affiliation': 'Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Salari', 'Affiliation': 'Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Ghani', 'Affiliation': 'Acute pain Service nurse, Chamran Hospital, Shiraz, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Tahmasebi', 'Affiliation': 'CRNA, Chamran Hospital, Shiraz, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Jamali', 'Affiliation': 'CRNA, Chamran Hospital, Shiraz, Iran.'}]",Bulletin of emergency and trauma,['10.30476/BEAT.2020.46446']
2267,32420435,Revision Total Knee Arthroplasty Is Associated With Significantly Higher Opioid Consumption as Compared With Primary Total Knee Arthroplasty in the Acute Postoperative Period.,"Background


There is a scarcity of studies investigating narcotic use after revision total knee arthroplasty (TKA). We compared immediate postsurgical narcotic consumption after revision TKA and primary TKA.
Methods


A single-institution database was used to identify patients who underwent revision TKA or primary TKA between 2016 and 2019. Morphine milligram equivalents (MMEs) were calculated to discern narcotic usage, and pain visual analog score was also used.
Results


A total of 7342 cases were identified: 88.65% primary TKA and 11.35% revision TKA. Opioid consumption for the first 24 hours postoperatively was significantly higher for the revision TKA group (133.1 MMEs vs 56.14 MMEs,  P  < .0001), as well as for the 24- to 48-hour time period. The visual analog pain scores were also higher for the revision TKA group.
Conclusion


The revision TKA group had a higher opioid requirement, most significant during the first 24 hours postoperatively, and expressed more pain in the acute postoperative period.",2020,"Opioid consumption for the first 24 hours postoperatively was significantly higher for the revision TKA group (133.1 MMEs vs 56.14 MMEs,  P  < .0001), as well as for the 24- to 48-hour time period.","['A total of 7342 cases were identified: 88.65% primary TKA and 11.35% revision TKA', 'patients who underwent revision TKA or primary TKA between 2016 and 2019']",['Morphine milligram equivalents (MMEs'],"['visual analog pain scores', 'Opioid consumption', 'discern narcotic usage, and pain visual analog score', 'pain']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0845666', 'cui_str': 'Revision of total knee arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",7342.0,0.0951915,"Opioid consumption for the first 24 hours postoperatively was significantly higher for the revision TKA group (133.1 MMEs vs 56.14 MMEs,  P  < .0001), as well as for the 24- to 48-hour time period.","[{'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Bernstein', 'Affiliation': 'NYU Langone, Department of Orthopedics - Division of Adult Joint Reconstruction, New York, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'NYU Langone, Department of Orthopedics - Division of Adult Joint Reconstruction, New York, NY, USA.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Mahure', 'Affiliation': 'NYU Langone, Department of Orthopedics - Division of Adult Joint Reconstruction, New York, NY, USA.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Schwarzkopf', 'Affiliation': 'NYU Langone, Department of Orthopedics - Division of Adult Joint Reconstruction, New York, NY, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'NYU Langone, Department of Orthopedics - Division of Adult Joint Reconstruction, New York, NY, USA.'}]",Arthroplasty today,['10.1016/j.artd.2020.04.001']
2268,32420463,RADIANCE - Radiochemotherapy with or without Durvalumab in the treatment of anal squamous cell carcinoma: A randomized multicenter phase II trial.,"Purpose


Anal squamous cell carcinomas (ASCC) are increasing in frequency across the developed world. The 3-year disease-free survival (DFS) in patients with locally-advanced disease is approximately 60% after primary radiochemotherapy (RCT). There is a strong rationale for combining immunotherapy with RCT in patients with ASCC due to its association with human papilloma virus (HPV) infection.
Methods/design


RADIANCE is an investigator initiated, prospective, multicenter, randomized phase II trial testing the addition of Durvalumab, a PD-L1 immune checkpoint inhibitor, to standard RCT in 178 patients with locally advanced ASCC (T2 ≥ 4 cm Nany, cT3-4 and/or cN+). In the control arm, patients will be treated with standard mitomycin C (MMC)/5-fluorouracil (5-FU)-based RCT. Intensity-modulated radiotherapy (IMRT) will be applied as follows: PTV_A (primary tumor) T1-T2 < 4 cm N+: 28 × 1.9 Gy = 53.2 Gy;  or  T2 ≥ 4 cm, T3-4 Nany: 31 × 1.9 Gy = 58.9 Gy; PTV_N (involved node): 28 × 1.8 Gy = 50.4 Gy ; and PTV_Elec (elective node): 28 × 1.43 Gy = 40.0 Gy over a period of 5,5-6 weeks. Concomitant chemotherapy will be administered using MMC with 5-FU during weeks 1 and 5 of radiotherapy (MMC 12 mg/m 2 , day 1 [maximum single dose 20 mg]; 5-FU 1000 mg/m 2  days 1-4 and 29-32). In the experimental arm, Durvalmab (1500 mg absolute dose, intravenously) will be combined with the same RCT as in the control arm. Immunotherapy with Durvalumab will start 14 days before initiation of standard RCT, administered every four weeks (q4w) thereafter for a total of twelve doses. The primary endpoint is disease-free survival (DFS) after 3 years.
Discussion


As ASCC is considered an immunogenically ""hot"" tumor due to its association with HPV infection, the combination of RCT with Durvalumab may improve tumor control and long-term clinical outcome in this patient collective compared to RCT alone.",2020,The 3-year disease-free survival (DFS) in patients with locally-advanced disease is approximately 60% after primary radiochemotherapy (RCT).,"['node', '58.9', 'anal squamous cell carcinoma', '178 patients with locally advanced ASCC (T2', 'patients with locally-advanced disease is approximately 60% after primary radiochemotherapy (RCT', '28\xa0×\xa01.8', 'Anal squamous cell carcinomas (ASCC', 'Nany', 'patients with ASCC', '28\xa0×\xa01.9']","['Durvalumab, a PD-L1 immune checkpoint inhibitor, to standard RCT', 'N', 'Concomitant chemotherapy', 'standard mitomycin C (MMC)/5-fluorouracil (5-FU)-based RCT', 'MMC with 5-FU', 'radiotherapy (MMC', 'Intensity-modulated radiotherapy (IMRT', 'Durvalmab', 'Radiochemotherapy with or without Durvalumab', '5-FU', 'Immunotherapy with Durvalumab']","['3-year disease-free survival (DFS', 'disease-free survival (DFS']","[{'cui': 'C0349534', 'cui_str': 'Carcinoma of anal margin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517517', 'cui_str': '1.9'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",178.0,0.12299,The 3-year disease-free survival (DFS) in patients with locally-advanced disease is approximately 60% after primary radiochemotherapy (RCT).,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Germany.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Balermpas', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zürich, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Gollrad', 'Affiliation': 'Department of Radiotherapy and Oncology, Charité University Hospital Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Weiß', 'Affiliation': 'Department of Radiotherapy and Oncology, Community Hospital Darmstadt, Germany.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Valentini', 'Affiliation': 'Department of Radiotherapy and Oncology, University Hospital Dresden, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stuschke', 'Affiliation': 'Department of Radiotherapy, University Hospital Essen, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Schäfer', 'Affiliation': 'Department of Radiotherapy, University Hospital Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Henckenberens', 'Affiliation': 'Department of Radiotherapy, University Hospital Hannover, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiology and Radiotherapy, University Hospital Heidelberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Department of Radiotherapy, University Hospital Schleswig Holstein, Kiel, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kuhnt', 'Affiliation': 'Department of Radiotherapy, University Hospital Leipzig, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Brunner', 'Affiliation': 'Department of Radiotherapy, University Hospital Magdeburg, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Bostel', 'Affiliation': 'Department of Radiation Oncology, University Hospital Mainz, Germany.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Engenhart-Cabillic', 'Affiliation': 'Department of Radiotherapy Radiation Oncology, University Hospital Marburg, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Nestle', 'Affiliation': 'Department of Radiation Oncology, Hospital Maria Hilf, Mönchengladbach, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Combs', 'Affiliation': 'Department of Radiation Oncology, Technical University of Munich (TUM), Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Belka', 'Affiliation': 'Department of Radiation Oncology, University Hospital LMU Munich, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hautmann', 'Affiliation': 'Department of Radiotherapy,University Hospital Regensburg, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Radiotherapy,University Hospital Rostock, Germany.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Gani', 'Affiliation': 'Department of Radiation Oncology,University Hospital Tübingen, Germany.'}, {'ForeName': 'Bülent', 'Initials': 'B', 'LastName': 'Polat', 'Affiliation': 'Department of Radiation Oncology, University of Würzburg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Germany.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Fokas', 'Affiliation': 'Department of Radiotherapy and Oncology, University of Frankfurt, Germany.'}]",Clinical and translational radiation oncology,['10.1016/j.ctro.2020.04.010']
2269,32420695,"A randomized, double-blind, vehicle-controlled clinical study of hair regeneration using adipose-derived stem cell constituent extract in androgenetic alopecia.","Accumulating evidence suggests that adipose-derived stem cell constituent extract (ADSC-CE) helps hair regrowth in patients with androgenetic alopecia (AGA). However, the effects of ADSC-CE have not been demonstrated in a randomized, double-blind, vehicle-controlled clinical trial. In this randomized, double-blind, vehicle-controlled clinical trial, 38 patients (29 men) with AGA were assigned to an intervention group (IG), with twice-daily self-application of the ADSC-CE topical solution over the scalp with fingers, or to a control group (CG). Changes in hair count and thickness from the baseline at 16 weeks were evaluated using a phototrichogram. Overall, 34 (89%) patients (mean age, 45.3 years) completed the study. The phototrichogram at week 8 showed more increase in hair count in the IG than in the CG, and intergroup differences in the change of hair count remained significant until week 16 with overall changes of 28.1% vs 7.1%, respectively. Similarly, a significant improvement in hair diameter was observed in the IG (14.2%) after 16 weeks when compared with hair diameter in the CG (6.3%). Our findings suggest that the application of the ADSC-CE topical solution has enormous potential as an alternative therapeutic strategy for hair regrowth in patients with AGA, by increasing both hair density and thickness while maintaining adequate treatment safety.",2020,"The phototrichogram at week 8 showed more increase in hair count in the IG than in the CG, and intergroup differences in the change of hair count remained significant until week 16 with overall changes of 28.1% vs 7.1%, respectively.","['patients with androgenetic alopecia (AGA', 'androgenetic alopecia', '38 patients (29 men) with AGA']","['hair regeneration using adipose-derived stem cell constituent extract', 'adipose-derived stem cell constituent extract (ADSC-CE', 'ADSC-CE', 'intervention group (IG), with twice-daily self-application of the ADSC-CE topical solution over the scalp with fingers, or to a control group (CG']","['hair count and thickness', 'hair count', 'change of hair count', 'hair diameter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0991555', 'cui_str': 'Cutaneous solution'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",38.0,0.46629,"The phototrichogram at week 8 showed more increase in hair count in the IG than in the CG, and intergroup differences in the change of hair count remained significant until week 16 with overall changes of 28.1% vs 7.1%, respectively.","[{'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Tak', 'Affiliation': 'Department of Family Medicine, Pusan National University School of Medicine, Yangsan, South Korea.'}, {'ForeName': 'Sang Yeoup', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Family Medicine Clinic and Research Institute of Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'A Ra', 'Initials': 'AR', 'LastName': 'Cho', 'Affiliation': 'Department of Family Medicine, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Young Sil', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'T-Stem, Co., Ltd, Changwon-si, South Korea.'}]",Stem cells translational medicine,['10.1002/sctm.19-0410']
2270,32420367,Improvement of Nutritional Status among Tuberculosis Patients by  Channa striata  Supplementation: A True Experimental Study in Indonesia.,"Objective


To analyze the effect of  Channa striata  supplementation on body mass index among tuberculosis patients, in which their health status is also investigated.
Methods


This study employed a true experiment. The study was designed randomized pretest-posttest with a control group, in which 200 respondents were enrolled. Body mass index (BMI), used as a nutritional status indicator, was measured every week for a month. Chi-square test was used to analyze the data with a significance level of 5% by STATA 13.
Results


The mean BMI of all groups increases during the month, in which rapid alteration occurs in the treatment group. The mean BMI (kg/m 2 ) in the treatment group at weeks 0-4 was reported to be 17.43, 17.65, 17.90, 18.04, and 18.22, respectively. Meanwhile, the mean BMI (kg/m 2 ) at weeks 0-4 in the control group was reported to be 17.20, 17.36, 17.57, 17.71, and 17.96, respectively. Furthermore, the alteration from severe thinness to higher BMI level in the treatment group is the highest. Based on the statistical test, there were no differences in BMI between the treatment and control groups ( p  > 0.05). However, the alteration of nutritional status in the treatment group is faster than that in the control group. In addition, there is no difference in their health status between the treatment and control groups ( p  > 0.05), except vomiting ( p  < 0.05).
Conclusion


The BMI among tuberculosis patients with  Channa striata  supplementation is increasing faster than that in the control group within a month with a minimum potential negative effect.",2020,"In addition, there is no difference in their health status between the treatment and control groups ( p  > 0.05), except vomiting ( p  < 0.05).
","['Tuberculosis Patients by', '200 respondents were enrolled', 'tuberculosis patients']","['Channa striata  supplementation', 'Channa striata  Supplementation']","['Nutritional Status', 'BMI level', 'body mass index', 'BMI', 'mean BMI', 'Body mass index (BMI', 'health status', 'except vomiting']","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",200.0,0.0157168,"In addition, there is no difference in their health status between the treatment and control groups ( p  > 0.05), except vomiting ( p  < 0.05).
","[{'ForeName': 'Isa', 'Initials': 'I', 'LastName': ""Ma'rufi"", 'Affiliation': 'Department of Environmental Health and Occupational Safety, School of Public Health, University of Jember, Jember Regency 68121, Indonesia.'}, {'ForeName': 'Khaidar', 'Initials': 'K', 'LastName': 'Ali', 'Affiliation': 'Department of Health Behavior, Environment and Social Medicine, Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta 55281, Indonesia.'}, {'ForeName': 'Sigit Kusuma', 'Initials': 'SK', 'LastName': 'Jati', 'Affiliation': 'Jember Chest Hospital, 68118 East Java, Indonesia.'}, {'ForeName': 'Anik', 'Initials': 'A', 'LastName': 'Sukmawati', 'Affiliation': 'Jember Chest Hospital, 68118 East Java, Indonesia.'}, {'ForeName': 'Kurnia', 'Initials': 'K', 'LastName': 'Ardiansyah', 'Affiliation': 'Department of Environmental Health and Occupational Safety, School of Public Health, University of Jember, Jember Regency 68121, Indonesia.'}, {'ForeName': 'Farida Wahyu', 'Initials': 'FW', 'LastName': 'Ningtyias', 'Affiliation': 'Department of Nutritional Health, School of Public Health, University of Jember, Jember Regency 68121, Indonesia.'}]",BioMed research international,['10.1155/2020/7491702']
2271,32420393,Functional Outcome of Surgical versus Conservative Therapy in Patients with Traumatic Thoracolumbar Fractures and Thoracolumbar Injury Classification and Severity Score of 4; A Non-randomized Clinical Trial.,"Objective


To compare the effectiveness of surgical intervention to conservative treatment in patients with thoracolumbar fracture and thoracolumbar injury classification and severity score (TLICS) of 4.
Methods


Twenty-five patients with TLICS 4 were enrolled in this non-randomized clinical trial. Based on clinical symptoms and radiologic findings, patients were considered under surgical or conservative treatments. The JOA Back Pain Evaluation Questionnaire (JOABPEQ) was assessed at baseline and at 3, 6, 12 months after treatment. A 20-point improvement from the baseline JOABPEQ scores was considered as clinical success in both the conservative and surgery groups. Additionally, residual canal, angulations and height loss were determined in all patients.
Results


Eight patients received conservative and 17 surgical treatment. Both study groups were comparable regarding the baseline characteristics. Both study demonstrated treatment success, regarding functional recovery when compared to baseline ( p <0.001). However, those undergoing surgical intervention had significantly better JOABPEQ score ( p <0.001) and higher residual canal ( p =0.042) when compared to those receiving conservative therapy. The success rate of treatment was comparable between the two study groups in 6- ( p =0.998) and 12-month ( p =0.852) intervals; however, surgical therapy had significantly higher success arte in 3-month interval ( p =0.031).
Conclusion


Our findings revealed that surgical treatment was preferred more in comparison to conservative treatment in patients with TLICS 4. Additionally, residual canal might be a modifying factor to decide the ideal therapeutic approach.",2020,"However, those undergoing surgical intervention had significantly better JOABPEQ score ( p <0.001) and higher residual canal ( p =0.042) when compared to those receiving conservative therapy.","['patients with TLICS 4', 'Methods\n\n\nTwenty-five patients with TLICS 4', 'Patients with Traumatic Thoracolumbar Fractures and Thoracolumbar Injury Classification and Severity Score of 4', 'patients with thoracolumbar fracture and thoracolumbar injury classification and severity score (TLICS) of 4', 'Eight patients received conservative and 17 surgical treatment']","['surgical intervention', 'Surgical versus Conservative Therapy']","['JOA Back Pain Evaluation Questionnaire (JOABPEQ', 'JOABPEQ score', 'success rate of treatment', 'residual canal, angulations and height loss', 'functional recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0559880', 'cui_str': 'Injury classification'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0424641', 'cui_str': 'Decrease in height'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}]",25.0,0.0360871,"However, those undergoing surgical intervention had significantly better JOABPEQ score ( p <0.001) and higher residual canal ( p =0.042) when compared to those receiving conservative therapy.","[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Koosha', 'Affiliation': 'Department of Neurosurgery, NHF hospital, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Nayeb Aghaei', 'Affiliation': 'Department of Neurosurgery, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Khayat Kashani', 'Affiliation': 'Department of Neurosurgery, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Paybast', 'Affiliation': 'Department of Neurology, Bou Ali Sina Hospital, Qazvin University of Medical Sciences, Qazvin, Iran.'}]",Bulletin of emergency and trauma,['10.30476/BEAT.2020.46448']
2272,32420683,"Discovery of Intake Biomarkers of Lentils, Chickpeas and White Beans by Untargeted LC-MS Metabolomics in Serum and Urine.","SCOPE


To identify reliable biomarkers of food intake (BFIs) of pulses.
METHODS AND RESULTS


A randomized crossover postprandial intervention study was conducted on 11 volunteers who consumed lentils, chickpeas and white beans. Urine and serum samples were collected at distinct postprandial time points up to 48 h, and analyzed by LC-HR-MS untargeted metabolomics. Hypaphorine, trigonelline, several small peptides and polyphenol-derived metabolites proved to be the most discriminating urinary metabolites. Two arginine-related compounds, dopamine sulfate and epicatechin metabolites, with their microbial derivatives, were identified only after intake of lentils, whereas protocatechuic acid was identified only after consumption of chickpeas. Urinary hydroxyjasmonic and hydroxydihydrojasmonic acids, as well as serum pipecolic acid and methylcysteine, were found after white bean consumption. Most of the metabolites identified in the postprandial study were replicated as discriminants in 24 h urine samples, demonstrating that in this case the use of a single, noninvasive sample was suitable for revealing the consumption of pulses.
CONCLUSIONS


The results of the present untargeted metabolomics work revealed a broad list of metabolites that are candidates for use as biomarkers of pulse intake. Further studies are needed to validate these BFIs and to find the best combinations of them to boost their specificity. This article is protected by copyright. All rights reserved.",2020,"Urinary hydroxyjasmonic and hydroxydihydrojasmonic acids, as well as serum pipecolic acid and methylcysteine, were found after white bean consumption.","['11 volunteers who consumed lentils, chickpeas and white beans']","['Hypaphorine, trigonelline', 'dopamine sulfate and epicatechin metabolites']",['Urine and serum samples'],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0950052', 'cui_str': 'Chick peas'}, {'cui': 'C0446305', 'cui_str': 'White bean'}]","[{'cui': 'C0064754', 'cui_str': 'lenticin'}, {'cui': 'C0077132', 'cui_str': 'trigonelline'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0014485', 'cui_str': '(-)-Epicatechin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}]",11.0,0.0132396,"Urinary hydroxyjasmonic and hydroxydihydrojasmonic acids, as well as serum pipecolic acid and methylcysteine, were found after white bean consumption.","[{'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Garcia-Aloy', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Marynka', 'Initials': 'M', 'LastName': 'Ulaszewska', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Center, Fondazione Edmund Mach (FEM), San Michele all'Adige, Italy.""}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Franceschi', 'Affiliation': ""Computational Biology Unit, Research and Innovation Center, Fondazione Edmund Mach, San Michele all'Adige, Italy.""}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Estruel-Amades', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Christoph H', 'Initials': 'CH', 'LastName': 'Weinert', 'Affiliation': 'Department of Safety and Quality of Fruit and Vegetables, Max Rubner-Institut, Federal Research Institute of Nutrition and Food, Karlsruhe, Germany.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Tor-Roca', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Urpi-Sarda', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Mattivi', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Center, Fondazione Edmund Mach (FEM), San Michele all'Adige, Italy.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andres-Lacueva', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901137']
2273,32420649,Comparison of vortioxetine and sertraline for treatment of major depressive disorder in elderly patients: A double-blind randomized trial.,"WHAT IS KNOWN AND OBJECTIVE


Major depressive disorder (MDD) is a complex disease and one of the leading contributors to disease burden throughout the world. In the current study, we explored the efficacy and tolerability of vortioxetine versus sertraline on symptoms of depression in elderly patients with MDD.
METHODS


Sixty patients diagnosed with MDD (based on DSM-5) and Hamilton Depression Rating Scale (HAM-D) score ≥ 19 were entered into a randomized double-blind study and were randomized to receive either vortioxetine (15 mg daily) or sertraline (75 mg daily) for six weeks. Patients were assessed using the HAM-D scale at baseline and weeks 3 and 6. Changes in HAM-D score, response rates, remission rate and time to response or remission were also compared between the two study groups.
RESULTS AND DISCUSSION


Fifty patients completed the trial after six weeks. General linear model repeated measures demonstrated no difference in trend of the two treatment groups (P = .897). There was no significantly different improvement in the HDRS scores from baseline to weeks 3 and 6, as well. Differences in response rate, remission rate, time to response and time to remission periods were not statistically significant. Finally, there was not any significantly difference between the two study groups in the frequency of adverse events.
WHAT IS NEW AND CONCLUSION


This study showed no significant differences in the efficacy and safety of vortioxetine in comparison with sertraline in order for it to be used safely for treatment of major depressive disorder in elderly patients.",2020,This study showed no significant differences in the efficacy and safety of vortioxetine in comparison with sertraline in order for it to be used safely for treatment of major depressive disorder in elderly patients.,"['elderly patients with MDD', 'Sixty patients diagnosed with MDD (based on DSM-5) and Hamilton Depression Rating Scale (HAM-D) score\xa0≥\xa019', 'major depressive disorder in elderly patients', 'Fifty patients completed the trial after six weeks']","['vortioxetine', 'vortioxetine and sertraline', 'sertraline']","['HAM-D scale', 'HDRS scores', 'frequency of adverse events', 'efficacy and tolerability', 'efficacy and safety', 'HAM-D score, response rates, remission rate and time to response or remission', 'response rate, remission rate, time to response and time to remission periods']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",60.0,0.192844,This study showed no significant differences in the efficacy and safety of vortioxetine in comparison with sertraline in order for it to be used safely for treatment of major depressive disorder in elderly patients.,"[{'ForeName': 'Firouzeh', 'Initials': 'F', 'LastName': 'Borhannejad', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Shariati', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Naderi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Shalbafan', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amirhosein', 'Initials': 'A', 'LastName': 'Mortezaei', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Sahebolzamani', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atefe', 'Initials': 'A', 'LastName': 'Saeb', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyed', 'Initials': 'S', 'LastName': 'Hosein Mortazavi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Kamalzadeh', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Aqamolaei', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Ali Noorbala', 'Affiliation': 'Psychosomatic Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Namazi-Shabestari', 'Affiliation': 'Department of Geriatric, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13177']
2274,32420754,Who benefits most from resilience-building groups for 'at-risk' older people? a pilot service-evaluation.,"Objectives:  Resilience-building interventions have not yet targeted older adults, despite the importance of well-being for maintaining independence and health. The 'My Generation' programme aims to build resilience through greater access to social networks, well-being activities, and psycho-educational support; this paper examines service evaluation data from its pilot implementation to identify factors leading to positive outcomes. Method:  The 'My Generation' programme comprises eight weekly 2-hour group sessions; each session includes both psychoeducation and a well-being activity. Participants were invited to complete questionnaires at the start and end of the course, and 12 weeks later. These included measures of well-being, loneliness, social connections and self-efficacy. Results:  Baseline assessments were completed by 239 older people (average age 71, range 50-97), attending 38 courses in four centres. Most were female (80%), 40% were widowed, 25% divorced/separated and 64% lived alone. Demographics did not differ between those completing post-intervention assessments ( N  = 137) and those who did not. Compared with normative data, participants had significantly lower well-being and greater feelings of loneliness than age-peers. Significant improvements in well-being, self-efficacy, social connections and one measure of loneliness were evident at post-intervention and follow-up assessments. Improvement in well-being at post-intervention was greater in those who were divorced/separated and who were not carers, and at follow-up in females and those living alone. Conclusion:  The 'My Generation' package appeared effective in improving well-being, self-efficacy, social connections and aspects of loneliness in at-risk older people. More research is needed to identify the intervention's key components and possible between-centre differences in outcomes.",2020,"Significant improvements in well-being, self-efficacy, social connections and one measure of loneliness were evident at post-intervention and follow-up assessments.","['239 older people (average age 71, range 50-97), attending 38 courses in four centres']",['Resilience-building interventions'],"['feelings of loneliness', 'well-being, self-efficacy, social connections and one measure of loneliness', 'well-being, loneliness, social connections and self-efficacy']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0289284,"Significant improvements in well-being, self-efficacy, social connections and one measure of loneliness were evident at post-intervention and follow-up assessments.","[{'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Woods', 'Affiliation': 'Dementia Services Development Centre, School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Ecorys UK, Birmingham, UK.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Diep', 'Affiliation': 'Ecorys UK, Birmingham, UK.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Parker', 'Affiliation': 'Merthyr & the Valleys Mind, Merthyr Tydfil, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'James', 'Affiliation': 'Mind Cymru, Cardiff, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Diggle', 'Affiliation': 'Mind, London, UK.'}]",Aging & mental health,['10.1080/13607863.2020.1765315']
2275,31544345,A Protocol to Deliver Intensive Behavioral Therapy (IBT) for Obesity in Primary Care Settings: The MODEL-IBT Program.,"OBJECTIVE


The Centers for Medicare and Medicaid Services (CMS) initiated coverage of intensive behavioral therapy (IBT) for obesity in 2011, providing beneficiaries 14 to 15 brief, individual counseling visits in 6 months. CMS offered general recommendations for delivering IBT but did not provide an evidence-based treatment protocol, which was the objective of the present research.
METHODS


This review describes the evidence that CMS considered in developing its IBT benefit. It also examines weight losses produced by the intensive lifestyle intervention in the Diabetes Prevention Program (DPP), as well an adapted version of the DPP delivered (for the first 6 months) on the visit schedule recommended by CMS. This new protocol, which was evaluated in a recent randomized trial, provided 14 visits in the first 24 weeks, with 7 additional monthly visits through week 52.
RESULTS


As reported previously, the 50 participants with obesity assigned to the new IBT protocol lost a mean of 5.4% of their initial weight at week 24; 46% of participants lost ≥ 5% of their baseline weight. At 1 year, the mean loss was 6.1%, and 44% of participants lost ≥ 5%.
CONCLUSIONS


With these generally favorable results, the IBT protocol is being posted online for practitioners and researchers to use.",2019,"CONCLUSIONS


With these generally favorable results","['14 visits in the first 24 weeks, with 7 additional monthly visits through week 52', 'obesity in 2011, providing beneficiaries 14 to 15 brief, individual counseling visits in 6 months', '50 participants with obesity assigned to the new IBT protocol lost a mean of 5.4% of their initial weight at week 24; 46% of participants lost\u2009≥\u20095% of their baseline weight']","['CMS', 'intensive behavioral therapy (IBT', 'Intensive Behavioral Therapy (IBT']","['weight losses', 'mean loss']","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",50.0,0.0506641,"CONCLUSIONS


With these generally favorable results","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Adam G', 'Initials': 'AG', 'LastName': 'Tsai', 'Affiliation': 'Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Jena Shaw', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22594']
2276,31411376,Effect of Meal Acceptability on Postprandial Appetite Scores and Hormones of Male Participants with Varied Adiposity.,"OBJECTIVE


This study portrays the effect of hedonic manipulation (high acceptability [HA] vs. low acceptability [LA]) on postprandial hormones and appetite scores in healthy males.
METHODS


Thirty participants (15 with normal weight and 15 with obesity) were recruited for a randomized, crossover design. They were randomly assigned to the HA or LA (with acesulfame-K) custard. Blood samples were drawn before the meals and for 4 hours after the meals and were analyzed for glucose, insulin, ghrelin, and glucagonlike peptide 1 (GLP-1). Appetite scores and subsequent energy intake were recorded.
RESULTS


Postprandial glucose, insulin, and ghrelin were different according to adiposity, whereas meal acceptability did not correspond to any significant difference in postprandial glucose, insulin, ghrelin, and GLP-1 concentrations. Appetite scores showed lower hunger, higher satiety, and fullness after the HA meal without a significant difference between the meals. Subsequent energy intake, expressed as a percentage of the resting energy expenditure, was higher in participants with obesity but did not reflect postprandial hormones and appetite scores; there was no significant difference between meals.
CONCLUSIONS


Hedonic properties and palatability do not affect gut hormones, mainly ghrelin and GLP-1. Moreover, their postprandial concentrations were not paralleled by similar changes in appetite scores, and both were not found to affect subsequent intake.",2019,"Appetite scores showed lower hunger, higher satiety, and fullness after the HA meal without a significant difference between the meals.","['healthy males', 'Thirty participants (15 with normal weight and 15 with obesity', 'Male Participants with Varied Adiposity']","['Meal Acceptability', 'HA or LA', 'hedonic manipulation (high acceptability [HA] vs. low acceptability [LA']","['postprandial hormones and appetite scores', 'Postprandial Appetite Scores', 'postprandial glucose, insulin, ghrelin, and GLP-1 concentrations', 'Postprandial glucose, insulin, and ghrelin', 'hunger, higher satiety, and fullness', 'postprandial concentrations', 'Appetite scores and subsequent energy intake', 'appetite scores']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",30.0,0.0515456,"Appetite scores showed lower hunger, higher satiety, and fullness after the HA meal without a significant difference between the meals.","[{'ForeName': 'Nehmat', 'Initials': 'N', 'LastName': 'El Helou', 'Affiliation': 'Department of Nutrition and Food Science, Faculty of Agricultural and Food Sciences, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Omar A', 'Initials': 'OA', 'LastName': 'Obeid', 'Affiliation': 'Department of Nutrition and Food Science, Faculty of Agricultural and Food Sciences, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Olabi', 'Affiliation': 'Department of Nutrition and Food Science, Faculty of Agricultural and Food Sciences, American University of Beirut, Beirut, Lebanon.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22583']
2277,32424335,Clonidine versus phenobarbital as adjunctive therapy for neonatal abstinence syndrome.,"OBJECTIVE


To compare clonidine versus phenobarbital as adjunctive therapy in infants who failed monotherapy with morphine for neonatal abstinence syndrome (NAS).
STUDY DESIGN


Prospective, randomized, open-label study of infants ≥ 35 weeks' gestation. Infants received clonidine or phenobarbital per protocol. Primary outcome was morphine treatment days. Secondary outcomes were inpatient adjunctive days, length of stay (LOS), triple therapy, safety, and readmission rates.
RESULTS


A total of 25 infants were treated with clonidine (n = 14) or phenobarbital (n = 11). Mean morphine treatment duration was significantly longer with clonidine (34.4 days, SD = 10.6) compared with phenobarbital (25.5 days, SD = 7.3, p = 0.026). The clonidine group also had higher inpatient adjunctive days (mean: 33.8 days [SD = 14.3] vs. 22 days [SD = 12.6], p = 0.042) and LOS (mean: 41.8 days [SD = 10.9] vs. 31 days [SD = 10]; p = 0.018) compared with phenobarbital.
CONCLUSIONS


Phenobarbital, as adjunctive therapy, led to significantly shorter duration of morphine therapy, inpatient adjunctive days, and length of stay compared with clonidine.",2020,"Mean morphine treatment duration was significantly longer with clonidine (34.4 days, SD = 10.6) compared with phenobarbital (25.5 days, SD = 7.3, p = 0.026).","['infants who failed monotherapy with morphine for neonatal abstinence syndrome (NAS', ""infants\u2009≥\u200935 weeks' gestation"", 'neonatal abstinence syndrome', '25 infants']","['clonidine', 'clonidine or phenobarbital', 'clonidine versus phenobarbital', 'phenobarbital', 'Clonidine', 'morphine']","['Mean morphine treatment duration', 'LOS', 'shorter duration of morphine therapy, inpatient adjunctive days, and length of stay', 'higher inpatient adjunctive days', 'inpatient adjunctive days, length of stay (LOS), triple therapy, safety, and readmission rates']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Abstinence Syndrome'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}]",25.0,0.0725641,"Mean morphine treatment duration was significantly longer with clonidine (34.4 days, SD = 10.6) compared with phenobarbital (25.5 days, SD = 7.3, p = 0.026).","[{'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Brusseau', 'Affiliation': 'Department of Pharmacy, University of Tennessee Medical Center, Knoxville, TN, USA. cbrussea@utmck.edu.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Burnette', 'Affiliation': 'Department of Neonatology, University of Tennessee Medical Center, Knoxville, TN, USA.'}, {'ForeName': 'R Eric', 'Initials': 'RE', 'LastName': 'Heidel', 'Affiliation': 'Department of Surgery, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0685-2']
2278,32424376,Evaluation of residual contamination on healing abutments after cleaning with a protein-denaturing agent and detergent.,"OBJECTIVE


This study evaluated the cleaning potential of a protein-denaturing agent with or without anionic detergent by monitoring the residual contamination on healing abutments used for dental implant treatment.
METHOD AND MATERIALS


Forty contaminated healing abutments removed from patients were randomized and immediately treated with differing cleaning methods; either Method A (presoaking in 1% sodium dodecyl sulfate followed by ultrasonication with 4 mol/L guanidine hydrochloride), or Method B (soaking in distilled water followed by ultrasonication with 4 mol/L guanidine hydrochloride) was used. Samples were stained with phloxine B and photographed using a light microscope. The proportion of stained and contaminated areas on each healing abutment was then calculated using Image J. The surface was examined with a scanning electron microscope and energy-dispersive x-ray spectroscopy.
RESULTS


The percentages of contaminated surfaces of the screwdriver engagement region, upper body, and lower body for methods A and B were 50% and 38%, 10% and 80%, and 38% and 18%, respectively. There was a statistically significant difference (engagement region [P < .001], upper body [P = .043], and lower body [P = .017]; Mann-Whitney) regarding the residually stained areas between the two cleaning methods. No surface alterations were seen by scanning electron microscopy. Energy-dispersive x-ray spectroscopy confirmed that the cleaned surfaces of the healing abutments revealed no signs of organic contamination.
CONCLUSION


Although the combination of a strong denaturing agent and detergent effectively cleaned contaminated healing abutments, perfect cleaning was not always possible, indicating that the reuse of healing abutments in different patients is not recommended.",2020,"There was a statistically significant difference (engagement region [P < .001], upper body [P = .043], and lower body [P = .017]; Mann-Whitney) regarding the residually stained areas between the two cleaning methods.",['Forty contaminated healing abutments removed from patients'],"['protein-denaturing agent with or without anionic detergent', 'Method A (presoaking in 1% sodium dodecyl sulfate followed by ultrasonication with 4 mol/L guanidine hydrochloride), or Method B (soaking in distilled water followed by ultrasonication with 4 mol/L guanidine hydrochloride']",['proportion of stained and contaminated areas on each healing abutment'],"[{'cui': 'C3266125', 'cui_str': 'Healing abutment'}, {'cui': 'C1292747', 'cui_str': 'Removes from'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0011740', 'cui_str': 'Detergent'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0347982', 'cui_str': 'mol/L'}, {'cui': 'C0120447', 'cui_str': 'Guanidine hydrochloride'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C3266125', 'cui_str': 'Healing abutment'}]",,0.0212855,"There was a statistically significant difference (engagement region [P < .001], upper body [P = .043], and lower body [P = .017]; Mann-Whitney) regarding the residually stained areas between the two cleaning methods.","[{'ForeName': 'Thiha Tin', 'Initials': 'TT', 'LastName': 'Kyaw', 'Affiliation': ''}, {'ForeName': 'Hidemi', 'Initials': 'H', 'LastName': 'Nakata', 'Affiliation': ''}, {'ForeName': 'Miyahara', 'Initials': 'M', 'LastName': 'Takayuki', 'Affiliation': ''}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kuroda', 'Affiliation': ''}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Kasugai', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44546']
2279,25682731,The impact of perinatal depression on exclusive breastfeeding: a cohort study.,"Perinatal depression is associated with infant undernutrition. We hypothesised that perinatal depression was associated with early cessation of exclusive breastfeeding and reduced quantity of breast milk in rural Pakistan. We used a prospective cohort design to study a population-based sample of 132 depressed and 147 non-depressed women from the third trimester of pregnancy to 6 months post-natal. Current major depressive episode was measured in the third trimester and 6 months post-natal using the Structured Clinical Interview for DSM-IV Diagnosis. In a convenience sample of 24 depressed and 31 non-depressed exclusively breastfeeding mothers, breast milk quantity was assessed (mL kg(-1) infant weight per 24 h) at 4 months using the dose-to-mother deuterium dilution method. We administered also the Perception of Insufficient Milk questionnaire at 6 months post-natal. Depression was associated with fewer days of exclusive breastfeeding (91.8 (SD = 47.1) vs. 108.7 days (SD = 54.3) (95% CI: 3.4 to 30.3 P = 0.014). Women with persistent depression ceased exclusive breastfeed earliest. There was no difference in the quantity of breast milk produced by depressed and non-depressed mothers: 89.3 (SD = 38.1) vs. 83.9 (29.0) ml/kg infant wt/24 hours, P = 0.57. Depressed mothers were significantly more likely to report insufficient milk: PIM scores were 34.4 (SD = 14.3) for depressed and 39.7 (SD = 10.4) for non-depressed women (P = 0.004). In Cox regression PIM score mediated the association between depression and early cessation of breastfeeding. In this area of rural Pakistan, perinatal depression is associated with early cessation of exclusive breastfeeding and this is associated with mothers' perceptions of insufficiency of breast milk but not reduced milk production.",2016,Depression was associated with fewer days of exclusive breastfeeding (91.8 (SD = 47.1) vs. 108.7 days (SD = 54.3) (95% CI: 3.4 to 30.3 P = 0.014).,"['Women with persistent depression ceased exclusive breastfeed earliest', 'population-based sample of 132 depressed and 147 non-depressed women from the third trimester of pregnancy to 6 months post-natal']",[],"['Depression', 'quantity of breast milk', 'report insufficient milk: PIM scores', 'breast milk quantity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0454729', 'cui_str': 'Natal (geographic location)'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",132.0,0.0369886,Depression was associated with fewer days of exclusive breastfeeding (91.8 (SD = 47.1) vs. 108.7 days (SD = 54.3) (95% CI: 3.4 to 30.3 P = 0.014).,"[{'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Assad', 'Initials': 'A', 'LastName': 'Hafeez', 'Affiliation': 'Health Services Academy, Islamabad, Pakistan.'}, {'ForeName': 'Rakshanda', 'Initials': 'R', 'LastName': 'Bilal', 'Affiliation': 'Life Science Group, Isotope Application Division, PINSTECH, Islamabad, Pakistan.'}, {'ForeName': 'Siham', 'Initials': 'S', 'LastName': 'Sikander', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Abid', 'Initials': 'A', 'LastName': 'Malik', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Fareed', 'Initials': 'F', 'LastName': 'Minhas', 'Affiliation': 'Benazir Bhutto Hospital, Institute of Psychiatry, Rawalpindi, Pakistan.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Tomenson', 'Affiliation': 'Biostatistics Unit, Institute of Population Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Creed', 'Affiliation': 'Institute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, UK.'}]",Maternal & child nutrition,['10.1111/mcn.12170']
2280,25682798,Adding multiple micronutrient powders to a homestead food production programme yields marginally significant benefit on anaemia reduction among young children in Nepal.,"Anaemia affects 46% of preschool-aged children in Nepal. A cluster-randomised study was conducted in rural Nepal to test whether providing micronutrient powders (MNP) in addition to enhanced homestead food production (EHFP) programme, consisting of home gardens, poultry and nutrition education, could lead to a higher reduction in anaemia compared with providing only EHFP. This sub-study enrolled 335 children aged 6-9 months into one of three groups: (1) EHFP + MNP; (2) EHFP; or (3) control. The EHFP + MNP group received 60 sachets of MNP for flexible consumption at the start and 6 months later for a total supplementation period of 11 months. The MNP contained 15 micronutrients including iron (10 mg encapsulated ferrous fumarate). Haemoglobin and anthropometry were measured at baseline and post-MNP supplementation. Mean ± SE haemoglobin concentration increased significantly in all groups, with a slightly higher but non-significant increase in the EHFP + MNP and EHFP compared with control (difference-in-differences: 4.1 g L(-1) for EHFP + MNP vs. control; 3.6 g L(-1) for EHFP vs. control; 0.5 g L(-1) for EHFP + MNP vs. EHFP). Anaemia decreased at a slightly higher magnitude in the EHFP + MNP [51.5 percentage points (PP)] than the EHFP (48.6 PP) and control (39.6 PP), with adjusted odds ratios (95% CI) at post-supplementation of 0.52 (0.25-1.12) for EHFP + MNP and 0.69 (0.35-1.36) for EHFP, compared with control. There was no impact on child growth. Combining EHFP and MNP programmes yielded a marginally significant reduction in anaemia among children.",2015,"Mean ± SE haemoglobin concentration increased significantly in all groups, with a slightly higher but non-significant increase in the EHFP + MNP and EHFP compared with control (difference-in-differences: 4.1 g L(-1) for EHFP + MNP vs. control; 3.6 g L(-1) for EHFP vs. control; 0.5 g L(-1) for EHFP + MNP vs. EHFP).","['Anaemia affects 46% of preschool-aged children in Nepal', 'young children in Nepal', '335 children aged 6-9 months into one of three groups: (1']","['micronutrient powders (MNP) in addition to enhanced homestead food production (EHFP) programme, consisting of home gardens, poultry and nutrition education', 'EHFP\u2009+\u2009MNP; (2) EHFP; or (3) control']","['EHFP\u2009+\u2009MNP and EHFP', 'Mean\u2009±\u2009SE haemoglobin concentration', 'Anaemia', 'anaemia', 'child growth', 'anaemia reduction', 'Haemoglobin and anthropometry']","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0033268'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4019428', 'cui_str': 'Gardens'}, {'cui': 'C0452888', 'cui_str': 'Poultry (substance)'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}]",335.0,0.0464332,"Mean ± SE haemoglobin concentration increased significantly in all groups, with a slightly higher but non-significant increase in the EHFP + MNP and EHFP compared with control (difference-in-differences: 4.1 g L(-1) for EHFP + MNP vs. control; 3.6 g L(-1) for EHFP vs. control; 0.5 g L(-1) for EHFP + MNP vs. EHFP).","[{'ForeName': 'Akoto K', 'Initials': 'AK', 'LastName': 'Osei', 'Affiliation': 'Asia Pacific Regional Office, Helen Keller International, Phnom Penh, Cambodia.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Pandey', 'Affiliation': 'Helen Keller International, Kathmandu, Nepal.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Spiro', 'Affiliation': 'RTI International, Jakarta, Indonesia.'}, {'ForeName': 'Debendra', 'Initials': 'D', 'LastName': 'Adhikari', 'Affiliation': 'Helen Keller International, Kathmandu, Nepal.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Haselow', 'Affiliation': 'Asia Pacific Regional Office, Helen Keller International, Phnom Penh, Cambodia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'De Morais', 'Affiliation': 'Helen Keller International, Kathmandu, Nepal.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Davis', 'Affiliation': 'Helen Keller International, Kathmandu, Nepal.'}]",Maternal & child nutrition,['10.1111/mcn.12173']
2281,32424430,"A randomized phase III study comparing continuation and discontinuation of PD-1 pathway inhibitors for patients with advanced non-small-cell lung cancer (JCOG1701, SAVE study).","The development of PD-1 pathway inhibitors has dramatically altered the treatment of advanced/recurrent non-small-cell lung cancer patients. However, the prognostic significance of their ongoing usage is controversial, especially for patients who have not progressed for a period of time. If discontinuation has no negative impact on survival, suspension may reduce side effects from toxicity and help alleviate the economic burdens on health insurance systems and patients. This randomized controlled trial enrolls patients who have responded well to PD-1 pathway inhibitors for >12 months. The aim is to confirm the non-inferiority of discontinuation of PD-1 pathway inhibitors, relative to continuation, in terms of overall survival. A total of 216 patients will be enrolled over 3 years. This trial has been registered in the Japan Registry for Clinical Trials as jRCT1031190032 (https://jrct.niph.go.jp/). An ancillary study examining the prognostic and predictive role of circulating tumor DNA using Guardant360® is planned.",2020,"If discontinuation has no negative impact on survival, suspension may reduce side effects from toxicity and help alleviate the economic burdens on health insurance systems and patients.","['advanced/recurrent non-small-cell lung cancer patients', 'patients who have not progressed for a period of time', '216 patients will be enrolled over 3\xa0years', 'patients who have responded well to PD-1 pathway inhibitors for >12\xa0months', 'patients with advanced non-small-cell lung cancer (JCOG1701, SAVE study']",['PD-1 pathway inhibitors'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278517', 'cui_str': 'Non-small cell lung cancer recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}]",[],216.0,0.103545,"If discontinuation has no negative impact on survival, suspension may reduce side effects from toxicity and help alleviate the economic burdens on health insurance systems and patients.","[{'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Nomura', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Goto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Mizutani', 'Affiliation': 'Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kataoka', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Kawai', 'Affiliation': 'Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Okuma', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Haruyasu', 'Initials': 'H', 'LastName': 'Murakami', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Sunto-gun, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa054']
2282,32424421,Evaluating biomarkers for treatment selection from reproducibility studies.,"We consider evaluating new or more accurately measured predictive biomarkers for treatment selection based on a previous clinical trial involving standard biomarkers. Instead of rerunning the clinical trial with the new biomarkers, we propose a more efficient approach which requires only either conducting a reproducibility study in which the new biomarkers and standard biomarkers are both measured on a set of patient samples, or adopting replicated measures of the error-contaminated standard biomarkers in the original study. This approach is easier to conduct and much less expensive than studies that require new samples from patients randomized to the intervention. In addition, it makes it possible to perform the estimation of the clinical performance quickly, since there will be no requirement to wait for events to occur as would be the case with prospective validation. The treatment selection is assessed via a working model, but the proposed estimator of the mean restricted lifetime is valid even if the working model is misspecified. The proposed approach is assessed through simulation studies and applied to a cancer study.",2020,"The treatment selection is assessed via a working model, but the proposed estimator of the mean restricted lifetime is valid even if the working model is misspecified.",[],[],[],[],[],[],,0.0182639,"The treatment selection is assessed via a working model, but the proposed estimator of the mean restricted lifetime is valid even if the working model is misspecified.","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, University of Georgia, Athens, GA 30602, USA.'}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Dobbin', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, University of Georgia, Athens, GA 30602, USA.'}]","Biostatistics (Oxford, England)",['10.1093/biostatistics/kxaa018']
2283,32424499,Does physiotherapy applied in conjunction with compression brace treatment in patients with pectus carinatum have efficacy? A preliminary randomized-controlled study.,"PURPOSE


Non-invasive treatment of pectus carinatum (PC) deformity includes the use of a compression brace and exercises. In this study, we aimed to examine the effect of a physiotherapy protocol applied as adjunct to compression brace treatment in patients with PC.
METHODS


The study included 30 male patients between 11 and 18 years of age. Patients were randomly assigned into two groups: a brace treatment only group (Group 1) and a brace and physiotherapy group (Group 2). Patient demographics and disease-related properties, protrusion measurements, postural evaluations, deformity perceptions, life quality, and treatment satisfaction were evaluated.
RESULTS


Although both groups showed improvements based on external chest measurements related to PC protrusion following treatment (p < 0.001), Group 2 had more benefit from the treatment (effect size > 0.36) and displayed greater improvement in maximum protrusion degree and lateral length values (p < 0.05). Additionally, we found that patient perception of deformity, posture, psychological life quality, and treatment satisfaction scores were significantly better in Group 2 (p < 0.05).
CONCLUSION


Owing to the satisfaction and additional benefits observed in the physiotherapy group, we think that a proper cardiopulmonary and musculoskeletal exercise program should be applied concurrently with brace treatment for patients with PC deformity. Nevertheless, long-term outcomes need to be clarified in future studies.",2020,"Although both groups showed improvements based on external chest measurements related to PC protrusion following treatment (p < 0.001), Group 2 had more benefit from the treatment (effect size > 0.36) and displayed greater improvement in maximum protrusion degree and lateral length values (p < 0.05).","['patients with pectus carinatum', 'patients with PC deformity', 'patients with PC', '30 male patients between 11 and 18\xa0years of age']","['physiotherapy protocol', 'compression brace and exercises', 'brace treatment only group (Group 1) and a brace and physiotherapy', 'musculoskeletal exercise program']","['Patient demographics and disease-related properties, protrusion measurements, postural evaluations, deformity perceptions, life quality, and treatment satisfaction', 'maximum protrusion degree and lateral length values', 'patient perception of deformity, posture, psychological life quality, and treatment satisfaction scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0158731', 'cui_str': 'Congenital pectus carinatum'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0533754,"Although both groups showed improvements based on external chest measurements related to PC protrusion following treatment (p < 0.001), Group 2 had more benefit from the treatment (effect size > 0.36) and displayed greater improvement in maximum protrusion degree and lateral length values (p < 0.05).","[{'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Alaca', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Kerem Aydınlar Kampusu, Icerenkoy Mah. Kayısdagı Cad. No:32, Atasehir, 34752, Istanbul, Turkey. nuray.alaca@acibadem.edu.tr.'}, {'ForeName': 'İhsan', 'Initials': 'İ', 'LastName': 'Alaca', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Kerem Aydınlar Kampusu, Icerenkoy Mah. Kayısdagı Cad. No:32, Atasehir, 34752, Istanbul, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Yüksel', 'Affiliation': 'Chest Wall Deformities and Pectus Association, Zuhtupasa Mah. Kadıkoy, Istanbul, Turkey.'}]",Pediatric surgery international,['10.1007/s00383-020-04675-3']
2284,32424462,Comparison of the effects of injectable platelet-rich fibrin and autologous fibrin glue applications on palatal wound healing: a randomized controlled clinical trial.,"OBJECTIVE


The aim of this study was to compare the effects of AFG and i-PRF on palatal wound healing and postoperative discomfort.
MATERIALS AND METHODS


Thirty-six patients in need of FGG were divided into three groups. AFG (n = 12) or i-PRF (n = 12) was applied and compared with control group (n = 12). Wound healing with H 2 O 2  test, VAS, MSS, and LTH index were evaluated on the 3rd,7th, and 14th days and 1st month. The bleeding status was evaluated on the 3rd and 7th days. Palatal tissue thickness was measured at baseline, 1st month, and 3rd month.
RESULTS


Epithelialization was higher in the test groups on the 14th day than the control group (p < 0.05). MSS scores at the 14th day and 1st month were lower in the AFG group than the control and the i-PRF group (p < 0.05). In the AFG group, LTH levels at the 3rd,7th, and 14th days and 1 month were higher than control and i-PRF groups (p < 0.05). VAS scores of the AFG group were lower than the control and i-PRF groups at the 7th day (p < 0.05). Bleeding was lower in the test groups than in the control group (p < 0.05). There was no difference between the groups in terms of tissue thickness (p > 0.05).
CONCLUSION


AFG and i-PRF have positive effects on the healing process by accelerating wound healing and reducing postoperative morbidity. Therewithal, AFG has superior properties in wound healing compared with i-PRF.
CLINICAL RELEVANCE


Patient discomfort and pain feeling have a great effect on patient's tendency to surgery and platelet concentrates such as AFG and i-PRF overcome these problems and contribute to patient's quality of life.",2020,VAS scores of the AFG group were lower than the control and i-PRF groups at the 7th day (p < 0.05).,"['Thirty-six patients in need of FGG', 'palatal wound healing']","['AFG', 'injectable platelet-rich fibrin and autologous fibrin glue applications', 'AFG and i-PRF']","['bleeding status', 'LTH levels', 'Wound healing with H 2 O 2  test, VAS, MSS, and LTH index', 'Bleeding', 'MSS scores', 'tissue thickness', 'postoperative morbidity', 'VAS scores', 'Palatal tissue thickness', 'Epithelialization']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0033374', 'cui_str': 'Prolactin releasing factor'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0024814', 'cui_str': 'Marinesco-Sjögren syndrome'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}]",36.0,0.0208954,VAS scores of the AFG group were lower than the control and i-PRF groups at the 7th day (p < 0.05).,"[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kızıltoprak', 'Affiliation': 'Batman Oral and Dental Health Center, Batman, Turkey.'}, {'ForeName': 'Mustafa Özay', 'Initials': 'MÖ', 'LastName': 'Uslu', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Inonu University, 44280, Malatya, Turkey. mustafaozayuslu@hotmail.com.'}]",Clinical oral investigations,['10.1007/s00784-020-03320-6']
2285,32424486,"Continuous basal infusion versus programmed intermittent bolus for quadratus lumborum block after laparoscopic colorectal surgery: a randomized-controlled, double-blind study.","BACKGROUND


Quadratus lumborum block (QLB) has recently attracted attention as a part of multimodal analgesia after abdominal surgery. It has been shown that programmed intermittent boluses of local anesthetic can produce better analgesia and wider sensory blockade compared with continuous basal infusion with some peripheral nerve blocks. The present study was conducted to see if this theory holds true for QLB in patients undergoing laparoscopic colorectal surgery.
METHODS


Fifty patients undergoing laparoscopic colorectal surgery were divided into 2 groups to receive continuous basal infusion (group C) or programmed intermittent boluses (group PIB) of local anesthetic. After surgery, patients received the posterior approach to QLB and a catheter was introduced bilaterally. Patients in group C received a continuous infusion of 0.15% levobupivacaine at 3 ml/h, and those in group PIB received a bolus of 12 ml every 4 h. All patients received intravenous patient-controlled analgesia using fentanyl. Measurements were taken for cumulative fentanyl consumption, pain scores, cutaneous sensory blockade, analgesic requirements, and adverse events for 46 h.
RESULTS


The primary outcome of cumulative fentanyl consumption at 22 h showed no significant difference between the groups [group C: 11.9 (11.2-15.5) µg/kg (median (interquartile range)) and group PIB: 12.3 (11.6-15.3), p = 0.473]. Pain scores, demands for rescue analgesics, and spread of cutaneous sensory blockade were similar for the two groups.
CONCLUSION


Programmed intermittent boluses of local anesthetic for continuous QLB did not produce better analgesia or wider sensory blockade compared with continuous basal infusion in patients undergoing laparoscopic colorectal surgery.",2020,"Measurements were taken for cumulative fentanyl consumption, pain scores, cutaneous sensory blockade, analgesic requirements, and adverse events for 46 h.
","['Fifty patients undergoing laparoscopic colorectal surgery', 'patients undergoing laparoscopic colorectal surgery', 'quadratus lumborum block after laparoscopic colorectal surgery']","['Quadratus lumborum block (QLB', 'Continuous basal infusion', 'continuous basal infusion (group C) or programmed intermittent boluses (group PIB) of local anesthetic', 'intravenous patient-controlled analgesia using fentanyl', 'continuous infusion of 0.15% levobupivacaine']","['cumulative fentanyl consumption', 'cumulative fentanyl consumption, pain scores, cutaneous sensory blockade, analgesic requirements, and adverse events', 'Pain scores, demands for rescue analgesics, and spread of cutaneous sensory blockade']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1301695', 'cui_str': 'Intermittent bolus'}, {'cui': 'C1568156', 'cui_str': 'Pittsburgh compound B'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}]",50.0,0.158262,"Measurements were taken for cumulative fentanyl consumption, pain scores, cutaneous sensory blockade, analgesic requirements, and adverse events for 46 h.
","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Aoyama', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo City, Shimane, 693-8501, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Sakura', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo City, Shimane, 693-8501, Japan. ssakura@med.shimane-u.ac.jp.'}, {'ForeName': 'Aumjit', 'Initials': 'A', 'LastName': 'Wittayapairoj', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo City, Shimane, 693-8501, Japan.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Abe', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo City, Shimane, 693-8501, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Tadenuma', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo City, Shimane, 693-8501, Japan.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo City, Shimane, 693-8501, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02791-x']
2286,32424514,Antibiotic prophylaxis in ureteroscopy-time for a good quality randomised controlled trial?,,2020,,[],['Antibiotic prophylaxis'],[],[],"[{'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]",[],,0.160647,,"[{'ForeName': 'Dinul', 'Initials': 'D', 'LastName': 'Hettiarachchi', 'Affiliation': 'The Medical School, Newcastle University, Framlington Place, Newcastle Upon Tyne, NE2 4HH, UK. d.hettiarachchilage@ncl.ac.uk.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Veeratterapillay', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Harding', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle Upon Tyne, UK.'}]",World journal of urology,['10.1007/s00345-020-03252-6']
2287,32424445,Cosmetic outcomes and patient satisfaction compared between staples and subcuticular suture technique for wound closure after primary total knee arthroplasty: a randomized controlled trial.,"INTRODUCTION


Staples and subcuticular suture are commonly used wound closure techniques after total knee arthroplasty (TKA). To date, only a few studies have investigated the differences between these two wound closure methods in TKA. Accordingly, this study aimed to compare cosmetic outcome and patient satisfaction between staples and subcuticular suture for post-TKA wound closure.
MATERIALS AND METHODS


This prospective randomized controlled trial included patients scheduled to undergo TKA at the Department of Orthopaedic Surgery of Siriraj Hospital (Bangkok, Thailand) during June 2018-March 2019. Patients were randomized into the staples or subcuticular suture groups. Hollander Wound Evaluation Scale (HWES), cosmetic-visual analogue scale (VAS), and patient satisfaction-VAS were evaluated at the 6-week and 3-month follow-ups. Functional outcome by the modified Knee Society Knee Scoring System and wound complications were also assessed.
RESULTS


Sixty-two patients (31 per group) were included. There were no significant differences in the HWES, cosmetic-VAS, patient satisfaction-VAS, or wound complication rate between groups at the 6-week or 3-month follow-ups. Wound closure time was significantly shorter in the staples group (p < 0.001), but the total operative time was not significantly different between groups. Modified knee score was significantly better in the suture group at 6 weeks (p = 0.024), but there was no significant difference between groups at 3 months. Significant association was observed between patient satisfaction-VAS and cosmetic-VAS at the 6-week (p = 0.03) and 3-month (p = 0.021) follow-ups.
CONCLUSION


Subcuticular suture and staples were found to be comparable wound-closure options after TKA relative to cosmetic outcome, patient satisfaction, functional outcome, and wound complication rate at 3-months post-operation.",2020,"There were no significant differences in the HWES, cosmetic-VAS, patient satisfaction-VAS, or wound complication rate between groups at the 6-week or 3-month follow-ups.","['primary total knee arthroplasty', 'patients scheduled to undergo TKA at the Department of Orthopaedic Surgery of Siriraj Hospital (Bangkok, Thailand)\xa0during June 2018-March 2019', 'Sixty-two patients (31 per group) were included']","['Staples and subcuticular suture', 'staples and subcuticular suture technique', 'staples or subcuticular suture groups']","['patient satisfaction-VAS and cosmetic-VAS', 'Cosmetic outcomes and patient satisfaction', 'HWES, cosmetic-VAS, patient satisfaction-VAS, or wound complication rate', 'Hollander Wound Evaluation Scale (HWES), cosmetic-visual analogue scale (VAS), and patient satisfaction-VAS', 'patient satisfaction, functional outcome, and wound complication rate', 'modified Knee Society Knee Scoring System and wound complications', 'total operative time', 'Modified knee score', 'cosmetic outcome and patient satisfaction', 'Wound closure time']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0524633,"There were no significant differences in the HWES, cosmetic-VAS, patient satisfaction-VAS, or wound complication rate between groups at the 6-week or 3-month follow-ups.","[{'ForeName': 'Sarthak', 'Initials': 'S', 'LastName': 'Nepal', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wang Lang Road, Bangkok Noi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Pakpoom', 'Initials': 'P', 'LastName': 'Ruangsomboon', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wang Lang Road, Bangkok Noi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Pacharapol', 'Initials': 'P', 'LastName': 'Udomkiat', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wang Lang Road, Bangkok Noi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Aasis', 'Initials': 'A', 'LastName': 'Unnanuntana', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wang Lang Road, Bangkok Noi, Bangkok, 10700, Thailand. uaasis@gmail.com.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03479-3']
2288,32424502,Is there an association between perceived social support and cardiovascular health behaviours in people with severe mental illnesses?,"PURPOSE


People with severe mental illnesses (SMI) have an increased risk of cardiovascular disease (CVD). Research in the general population suggests that social support may protect against increased CVD morbidity and mortality; however, this may not apply to those with SMI. We aimed to explore the association between perceived social support and attendance at primary care nurse CVD risk reduction clinic appointments and CVD risk-reducing behaviours in an SMI population with elevated CVD risk factors.
METHODS


We used longitudinal and cross-sectional data from a randomised controlled trial on 326 adults with SMI recruited via 76 general practices in England. Multilevel regression analysis estimated the effect of perceived social support on attendance at CVD risk reduction clinic appointments over 6 months, and adherence to CVD medication, physical activity, diet, smoking and alcohol use at baseline, adjusted by age, sex, ethnicity, deprivation, psychiatric diagnosis and employment.
RESULTS


Perceived social support predicted greater appointment attendance in unadjusted (IRR = 1.005; 1.000-1.010; p = 0.05) but not adjusted analysis (IRR = 1.003; 0.998-1.009; p = 0.25). Perceived social support was associated with greater adherence to medication; for each 1% increase in social support, there was a 4.2% increase in medication adherence (OR = 1.042; 1.015-1.070; p = 0.002). No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS


Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.",2020,"No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS


Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.","['SMI population with elevated CVD risk factors', '326 adults with SMI recruited via 76 general practices in England', 'People with severe mental illnesses (SMI', 'people with severe mental illnesses']",[],"['CVD morbidity and mortality', 'appointment attendance', 'adherence to CVD medication, physical activity, diet, smoking and alcohol use at baseline, adjusted by age, sex, ethnicity, deprivation, psychiatric diagnosis and employment', 'social support and greater physical activity, lower sedentary behaviour, healthier diet', 'risk of cardiovascular disease (CVD', 'social support', 'medication adherence']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0376338', 'cui_str': 'Psychiatric Diagnosis'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",326.0,0.0483254,"No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS


Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Burton', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 6th floor, 149 Tottenham Court Road, London, W1T 7NF, UK. a.burton@ucl.ac.uk.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Walters', 'Affiliation': 'Department of Primary Care and Population Health, University College London, UCL Medical School (Royal Free Campus), Upper Third Floor, Rowland Hill Street, London, NW3 2PF, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Department of Primary Care and Population Health, University College London, UCL Medical School (Royal Free Campus), Upper Third Floor, Rowland Hill Street, London, NW3 2PF, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 6th floor, 149 Tottenham Court Road, London, W1T 7NF, UK.'}]",Social psychiatry and psychiatric epidemiology,['10.1007/s00127-020-01879-9']
2289,32424691,In vitro effect of children's toothpaste on brushing abrasion of eroded primary enamel.,"PURPOSE


Emerging data have suggested that acid erosion has become an increasing clinical problem in pediatric dentistry. This study aimed to investigate the abrasive effects of two commercial toothpastes on primary enamel eroded by orange juice using an in vitro model.
METHODS


Thirty enamel slabs were obtained from primary teeth and then randomly assigned to three groups (n = 8) comprising two different toothpastes: G1-control-distilled water; G2-Dentifrice A (containing no fluoride); and G3-Dentifrice B (1.100 ppmF-NaF). Each slab had one half protected to provide a control side, and the other one was subjected to treatments. The slabs were submitted to daily erosive challenges (3×/day, 2 min) in concentrated orange juice (pH 3.38) associated with abrasive challenges using a tooth-brushing machine (150 brush movements for each cycle). During the experimental period, the slabs were kept in 37 °C artificial saliva, and the experiment was carried out for 5 days. The depths of the resulting eroded areas were measured by stylus profilometry. The data were analyzed using ANOVA and the Tukey-Kramer test (α = 5%).
RESULTS


Tooth loss (µm, mean ± SD) was 2.46 ± 1.18 for G1, 3.32 ± 2.12 for G2 and 2.14 ± 1.03 for G3. Therefore, the NaF dentifrice (Dentifrice B) produced significantly less mineral loss (p = 0.04) than dentifrice A.
CONCLUSIONS


The findings suggest that fluoride toothpaste could protect primary enamel against erosion.",2020,"RESULTS


Tooth loss (µm, mean ± SD) was 2.46 ± 1.18 for G1, 3.32 ± 2.12 for G2 and 2.14 ± 1.03 for G3.","[""children's toothpaste on brushing abrasion of eroded primary enamel"", 'Thirty enamel slabs were obtained from primary teeth']","['toothpastes: G1-control-distilled water; G2-Dentifrice A (containing no fluoride); and G3-Dentifrice B (1.100 ppmF-NaF', 'commercial toothpastes', 'NaF dentifrice (Dentifrice B', 'fluoride toothpaste']","['mineral loss', 'Tooth loss (µm, mean\u2009±\u2009SD']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0059735', 'cui_str': 'Cytochrome p450 CYP1A1 enzyme'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}]","[{'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.032798,"RESULTS


Tooth loss (µm, mean ± SD) was 2.46 ± 1.18 for G1, 3.32 ± 2.12 for G2 and 2.14 ± 1.03 for G3.","[{'ForeName': 'V F', 'Initials': 'VF', 'LastName': 'Passos', 'Affiliation': 'Department of Operative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Cap. Francisco Pedro S/N-Rodolfo Teófilo, Fortaleza, CE, 60430-170, Brazil.'}, {'ForeName': 'R B R A', 'Initials': 'RBRA', 'LastName': 'Sousa', 'Affiliation': 'Department of Operative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Cap. Francisco Pedro S/N-Rodolfo Teófilo, Fortaleza, CE, 60430-170, Brazil.'}, {'ForeName': 'M A S', 'Initials': 'MAS', 'LastName': 'de Melo', 'Affiliation': 'Department of Operative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Cap. Francisco Pedro S/N-Rodolfo Teófilo, Fortaleza, CE, 60430-170, Brazil.'}, {'ForeName': 'E A B', 'Initials': 'EAB', 'LastName': 'Gomes', 'Affiliation': ""Departament of Academic Master's Degree in Dental Sciences, Christus University Center-Unichristus, Fortaleza, CE, Brazil.""}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Santiago', 'Affiliation': 'Department of Operative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Cap. Francisco Pedro S/N-Rodolfo Teófilo, Fortaleza, CE, 60430-170, Brazil.'}, {'ForeName': 'J P M', 'Initials': 'JPM', 'LastName': 'Lima', 'Affiliation': ""Departament of Academic Master's Degree in Dental Sciences, Christus University Center-Unichristus, Fortaleza, CE, Brazil. julianapml@yahoo.com.br.""}]",European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry,['10.1007/s40368-020-00536-8']
2290,31542446,Impact of customized-consumer medication information on health-related quality of life among patients with type 2 diabetes mellitus.,"BACKGROUND


The importance of providing accurate medication information that can be easily comprehended by patients to subsequently best use their medication(s) has been widely reported in the literature. Patient information leaflet (PIL) is a supporting tool aiding patients to make decisions about their treatment plan and improve patient-clinician communication and thus medication adherence. PIL is the written document produced by the pharmaceutical manufacturers and packed with the medicine. The available PILs do not consider cultural and behavioral perspectives of diverse populations residing in a country like Qatar. Consumer medication information (CMI) is written information about prescription drugs developed by organizations or individuals other than a drug's manufacturer that is intended for distribution to consumers at the time of drug dispensing.
OBJECTIVE


To investigate the impact of customized CMI (C-CMI) on health-related quality of life (HRQoL) among type 2 diabetes mellitus (T2DM) patients in Qatar.
METHODS


This was a randomized controlled intervention study, in which the intervention group patients received C-CMI and the control group patients received usual care. HRQoL was measured using the EQ-5D-5L questionnaire and EQ visual analog scale (EQ-VAS) at three intervals [i.e. baseline, after 3 months and 6 months].
RESULTS


The EQ-5D-5L index value for the intervention group exhibited sustained improvement from baseline to the third visit. There was a statistically significant difference between groups in the HRQoL utility value (represented as EQ index) at 6 months (0.939 vs. 0.796; p = 0.019). Similarly, the intervention group compared with the control group had significantly greater EQ-VAS at 6 months (90% vs. 80%; p = 0.003).
CONCLUSIONS


The impact of C-CMI on health outcomes of T2DM patients in Qatar reported improvement in HRQoL indicators among the intervention patients. The study built a platform for health policymakers and regulatory agencies to consider the provision of C-CMI in multiple languages.",2020,The EQ-5D-5L index value for the intervention group exhibited sustained improvement from baseline to the third visit.,"['patients with type 2 diabetes mellitus', 'type 2 diabetes mellitus (T2DM) patients in Qatar']","['customized CMI (C-CMI', 'C-CMI and the control group patients received usual care', 'customized-consumer medication information']","['EQ-5D-5L questionnaire and EQ visual analog scale (EQ-VAS', 'HRQoL', 'health-related quality of life (HRQoL', 'HRQoL indicators', 'health-related quality of life', 'EQ-5D-5L index value', 'HRQoL utility value', 'EQ-VAS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0034366', 'cui_str': 'State of Qatar'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0412891,The EQ-5D-5L index value for the intervention group exhibited sustained improvement from baseline to the third visit.,"[{'ForeName': 'Emad Eldin', 'Initials': 'EE', 'LastName': 'Munsour', 'Affiliation': 'Pharmacy and Drug Control Department, Ministry of Public Health, Doha, Qatar. Electronic address: emadkirra@gmail.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Awaisu', 'Affiliation': 'College of Pharmacy, Qatar University, Doha, Qatar.'}, {'ForeName': 'Mohamed Azmi', 'Initials': 'MA', 'LastName': 'Ahmad Hassali', 'Affiliation': 'School of Pharmaceutical Sciences, Universiti Sains Malaysia, Doha, Qatar.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Dabbous', 'Affiliation': 'Diabetes/Endocrinology, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Noran', 'Initials': 'N', 'LastName': 'Zahran', 'Affiliation': 'College of Pharmacy, Qatar University, Doha, Qatar.'}, {'ForeName': 'Enas', 'Initials': 'E', 'LastName': 'Abdoun', 'Affiliation': 'National Diabetes Center, Hamad Medical Corporation, Doha, Qatar.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.08.038']
2291,32424568,Monitor-based exoscopic 3D4k neurosurgical interventions: a two-phase prospective-randomized clinical evaluation of a novel hybrid device.,"BACKGROUND


Promoting a disruptive innovation in microsurgery, exoscopes promise alleviation of physical strain and improved image quality through digital visualization during microneurosurgical interventions. This study investigates the impact of a novel 3D4k hybrid exoscope (i.e., combining digital and optical visualization) on surgical performance and team workflow in preclinical and clinical neurosurgical settings.
METHODS


A pre-clinical workshop setting has been developed to assess usability and implementability through skill-based scenarios (neurosurgical participants n = 12). An intraoperative exploration in head and spine surgery (n = 9) and a randomized clinical study comparing ocular and monitor mode in supratentorial brain tumor cases (n = 20) followed within 12 months. Setup, procedure, case characteristics, surgical performance, and user experience have been analyzed for both ocular group (OG) and monitor group (MG).
RESULTS


Brain tumor cases using frontal, frontoparietal, or temporal approaches have been identified as favorable use cases for introducing exoscopic neurosurgery. Mean monitor distance and angle were 180 cm and 10°. Surgical ergonomics when sitting improved significantly in MG compared with OG (P = .03). Hand-eye coordination required familiarization in MG. Preclinical data showed a positive correlation between lateral camera inclination and impact on hand-eye coordination (r s  = 0.756, P = .01). There was no significant added surgical time in MG. Image quality in current generation 3D4k monitors has been rated inferior to optic visualization yet awaits updates.
CONCLUSIONS


The hybrid exoscopic device can be integrated into established neurosurgical workflows. Currently, exoscopic interventions seem most suited for cranial tumor surgery in lesions that are not deep-seated. Ergonomics improve in monitor mode compared to conventional microsurgery.",2020,Surgical ergonomics when sitting improved significantly in MG compared with OG (P = .03).,"['supratentorial brain tumor cases (n\u2009=\u200920) followed within 12\xa0months', 'head and spine surgery (n\u2009=\u20099']","['novel 3D4k hybrid exoscope (i.e., combining digital and optical visualization', 'Monitor-based exoscopic 3D4k neurosurgical interventions']","['Mean monitor distance and angle', 'surgical time', 'lateral camera inclination and impact on hand-eye coordination']","[{'cui': 'C1522407', 'cui_str': 'Supratentorial brain'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",,0.0957368,Surgical ergonomics when sitting improved significantly in MG compared with OG (P = .03).,"[{'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Roethe', 'Affiliation': 'Department of Neurosurgery, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany. anna.roethe@charite.de.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Landgraf', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Schröder', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Misch', 'Affiliation': 'Department of Neurosurgery, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vajkoczy', 'Affiliation': 'Department of Neurosurgery, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Picht', 'Affiliation': 'Department of Neurosurgery, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}]",Acta neurochirurgica,['10.1007/s00701-020-04361-2']
2292,31543407,Fast versus gradual adaptation of soft daily disposable contact lenses in neophyte wearers.,"PURPOSE


Despite the widespread practice of gradually adapting all new soft contact lens wearers (neophytes), there is little evidence-based research underpinning such practice. This work determined if a gradual adaptation period is necessary for neophytes when fitted with modern hydrogel or silicone-hydrogel daily disposable contact lenses.
METHOD


At four sites, neophytes (19-32 years) were randomly assigned to an adaptation schedule: fast (10 h wear from the first day) or gradual (4 h on the first day, increasing their wear-time by 2 h on each subsequent day until they had reached 10 h) with hydrogel (n = 24 fast; n = 21 gradual) or silicone-hydrogel (n = 10 fast; n = 10 gradual) contact lenses. Masked investigators graded ocular surface physiology and non-invasive tear breakup time (NIBUT). A range of subjective scores (using 0-100 visual analogue scales) were recorded at the initial visit and after 10 h of lens wear, 4-6 days and 12-14 days after initial fitting. Subjective scores were also repeated after 7 days.
RESULTS


There was no difference (p > 0.05) in ocular surface physiology between the fast and gradual adaptation groups at any time point in either lens type. NIBUT was similar at all time points for both adaptation groups in both lens types with the exception that the gradual adaptation silicone-hydrogel wearers had a slightly longer NIBUT (p = 0.007) than the fast adaptation group at 12-14 days. Subjective scores were also similar across the visits and lens types with the exception of 'lens awareness' and 'ease of lens removal' which were better (p < 0.05) in the fast compared with the gradual adaptation hydrogel lens group at day 7. Additionally, 'end-of-day discomfort' was better (p = 0.02) in the fast compared with the gradual adaptation hydrogel lens group at 12-14 days.
CONCLUSION


There appears to be no benefit in daily disposable soft contact lens adaptation for neophytes with modern contact lens materials.",2020,There was no difference (p > 0.05) in ocular surface physiology between the fast and gradual adaptation groups at any time point in either lens type.,"['soft contact lens wearers (neophytes', 'neophyte wearers', 'At four sites, neophytes (19-32 years']","['hydrogel (n\u202f=\u202f24 fast; n\u202f=\u202f21 gradual) or silicone-hydrogel (n\u202f=\u202f10 fast; n\u202f=\u202f10 gradual) contact lenses', 'Fast versus gradual adaptation of soft daily disposable contact lenses']","['Subjective scores', 'ocular surface physiology', ""lens awareness' and 'ease of lens removal""]","[{'cui': 'C0009838', 'cui_str': 'Soft Contact Lenses'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",100.0,0.0218066,There was no difference (p > 0.05) in ocular surface physiology between the fast and gradual adaptation groups at any time point in either lens type.,"[{'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Wolffsohn', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, UK. Electronic address: j.s.w.wolffsohn@aston.ac.uk.'}, {'ForeName': 'Harshali', 'Initials': 'H', 'LastName': 'Dhirajlal', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, UK. Electronic address: dhirajlh@aston.ac.uk.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Vianya-Estopa', 'Affiliation': 'Vision and Hearing Sciences, Anglia Ruskin University, Cambridge, UK. Electronic address: marta.vianya@anglia.ac.uk.'}, {'ForeName': 'Manbir', 'Initials': 'M', 'LastName': 'Nagra', 'Affiliation': 'School of Health Sciences and Social Work, University of Portsmouth, Portsmouth, UK. Electronic address: manbir.nagra@port.ac.uk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Madden', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, G4 0BA, UK. Electronic address: Louise.madedn@nes.scot.nhs.uk.'}, {'ForeName': 'Laura Elaine', 'Initials': 'LE', 'LastName': 'Sweeney', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, G4 0BA, UK. Electronic address: laura.sweeney@gcu.ac.uk.'}, {'ForeName': 'Anna Sarah', 'Initials': 'AS', 'LastName': 'Goodyear', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, G4 0BA, UK. Electronic address: agoody200@caledonian.ac.uk.'}, {'ForeName': 'Lauren Victoria', 'Initials': 'LV', 'LastName': 'Kerr', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, G4 0BA, UK. Electronic address: lkerr209@caledonian.ac.uk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Terry', 'Affiliation': 'School of Optometry and Vision Sciences, Cardiff University, Cardiff, CF24 4HQ, UK. Electronic address: terryl1@cardiff.ac.uk.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'School of Optometry and Vision Sciences, Cardiff University, Cardiff, CF24 4HQ, UK. Electronic address: sheikhsz@cardiff.ac.uk.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Murphy', 'Affiliation': 'School of Physics & Clinical & Optometric Sciences, Technological University Dublin, Ireland. Electronic address: orla.murphy@dit.ie.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': 'Lloyd', 'Affiliation': 'School of Physics & Clinical & Optometric Sciences, Technological University Dublin, Ireland. Electronic address: aoife.lloydmckernan@dit.ie.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Maldonado-Codina', 'Affiliation': 'Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK. Electronic address: carole.m-codina@manchester.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2019.08.011']
2293,32426156,A study protocol to assess the feasibility of conducting an evaluation trial of the ADVANCE integrated intervention to address both substance use and intimate partner abuse perpetration to men in substance use treatment.,"Background


Strong evidence exists that substance use is a contributory risk factor for intimate partner abuse (IPA) perpetration. Men in substance use treatment are more likely to perpetrate IPA than men from the general population. Despite this, referral pathways are lacking for this group. This trial will assess the feasibility of conducting an evaluation trial of a tailored integrated intervention to address substance use and IPA perpetration to men in substance use treatment.
Methods/design


ADVANCE is a multicentre, parallel-group individually randomised controlled feasibility trial, with a nested formative evaluation, comparing an integrated intervention to reduce IPA + substance use treatment as usual (TAU) to TAU only. One hundred and eight men who have perpetrated IPA in the past 12 months from community substance use treatment in London, the West Midlands, and the South West will be recruited. ADVANCE is a manualised intervention comprising 2-4 individual sessions (2 compulsory) with a keyworker to set goals, develop a personal safety plan and increase motivation and readiness, followed by a 12-session weekly group intervention delivered in substance use services. Men will be randomly allocated (ratio 1:1) to receive the ADVANCE intervention + TAU or TAU only. Men's female (ex) partners will be invited to provide outcome data and offered support from integrated safety services (ISS). Regular case management meetings between substance use and ISS will manage risk. Outcome measures will be obtained at the end of the intervention (approximately 4 months post-randomisation) for all male and female participants. The main objective of this feasibility trial is to estimate parameters required for planning a definitive trial including rates of consent, recruitment, and follow-up by site and group allocation. Nested formative evaluation including focus groups and in-depth interviews will explore the intervention's acceptability to participants, group facilitators, keyworkers and ISS workers. Secondary outcomes include substance use, IPA, mental health, self-management, health and social care service use, criminal justice contacts, and quality of life.
Discussion


Findings from this feasibility trial will inform the design of a multicentre randomised controlled trial evaluating the efficacy and cost-effectiveness of the ADVANCE intervention for reducing IPA and improving the well-being of female (ex)partners.
Trial registration


ISRCTN79435190.",2020,Men in substance use treatment are more likely to perpetrate IPA than men from the general population.,"['One hundred and eight men who have perpetrated IPA in the past 12 months from community substance use treatment in London, the West Midlands, and the South West will be recruited', ""Men's female (ex) partners""]",['tailored integrated intervention'],"['substance use, IPA, mental health, self-management, health and social care service use, criminal justice contacts, and quality of life']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0150359', 'cui_str': 'Substance use therapy'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0454882', 'cui_str': 'West Midlands'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086072', 'cui_str': 'Criminal Justice'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",108.0,0.0983465,Men in substance use treatment are more likely to perpetrate IPA than men from the general population.,"[{'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Gilchrist', 'Affiliation': ""1National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 4 Windsor Walk, London, SE5 8BB UK.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""2Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF UK.""}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Radcliffe', 'Affiliation': ""1National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 4 Windsor Walk, London, SE5 8BB UK.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McMurran', 'Affiliation': 'Independent Consulting Psychologist, Lancaster, UK.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Feder', 'Affiliation': '4School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Easton', 'Affiliation': '5Rochester Institute of Technology, 153 Lomb Memorial Drive, Rochester, NY 14623 USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': '6Department of Health Sciences, University of York, Seebohm Rowntree Building, Heslington, York, YO10 5DD UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kirkpatrick', 'Affiliation': '7RESPECT, The Green House, 244-254 Cambridge Heath Road, London, E2 9DA UK.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': ""1National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 4 Windsor Walk, London, SE5 8BB UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Potts', 'Affiliation': ""2Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF UK.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Stephens-Lewis', 'Affiliation': '8Centre for Violence Prevention, University of Worcester, Worcester, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': '9School of Health in Social Science, University of Edinburgh, 8-9 Hope Park Square, Edinburgh, 8HQ 9NW UK.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Love', 'Affiliation': ""1National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 4 Windsor Walk, London, SE5 8BB UK.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Halliwell', 'Affiliation': '4School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.'}, {'ForeName': 'Sandi', 'Initials': 'S', 'LastName': 'Dheensa', 'Affiliation': '4School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Berbary', 'Affiliation': '5Rochester Institute of Technology, 153 Lomb Memorial Drive, Rochester, NY 14623 USA.'}, {'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': '6Department of Health Sciences, University of York, Seebohm Rowntree Building, Heslington, York, YO10 5DD UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""1National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 4 Windsor Walk, London, SE5 8BB UK.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gilchrist', 'Affiliation': '9School of Health in Social Science, University of Edinburgh, 8-9 Hope Park Square, Edinburgh, 8HQ 9NW UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00580-7']
2294,32424821,Evaluation of Very Integrated Program (VIP): Health promotion for patients with alcohol and drug addiction - A Randomized Trial.,"BACKGROUND


Compared to the general population, patients with alcohol and drug addiction have an increased risk of additional hazardous lifestyles and suffer from more chronic diseases, adding to their already significantly higher morbidity and mortality. The objective of this study was to test the efficacy of the Very Integrated Program (VIP) on treatment and health outcomes for patients diagnosed with alcohol and drug addiction.
METHODS


Parallel randomized clinical trial with intervention as add-on to addiction care as usual. A total of 322 patients aged 18 years or older were identified, and the study requirements were fulfilled by 219 patients, 7 of whom participated in a pilot. The intervention was a 6-week intensive, tailored, educational program that included motivational interviewing, a smoking cessation program, dietary and physical activity counseling, and patient education. The main outcome measures were substance-free days, time to relapse and treatment adherence assessed after 6 weeks and 12 months. Secondary outcomes were lifestyle factors, symptoms of comorbidity, and quality of life. Missing data were imputed conservatively by using data closest to the follow-up date and baseline values in patients with no follow-up.
RESULTS


The 212 patients (intervention, n=113; control, n=99) were randomized, and 202 had complete data for primary outcomes. After 6 weeks, there were no significant differences between the groups regarding primary or secondary outcomes. At the 12-month follow-up, the patients in the control group had significantly more total substance-free days (139 days; ranging 0-365 vs. 265; 0-366, p=0.021) - specifically among the patients with drug addiction - and higher physical and mental quality of life (45 vs 58, p= 0.049 and 54 vs. 66, p=0.037), but not in the per-protocol analysis (60 vs. 46, p=0.52 and 70 vs. 66, p=0.74). The sensitivity analyses did not support significant differences between the groups.
CONCLUSION


Overall, adding VIP intervention did not improve outcome of the alcohol or drug addiction care or the lifestyle compared to the addiction care alone. This patient group is still in need of effective programs and new intervention research is required to develop that.",2020,"At the 12-month follow-up, the patients in the control group had significantly more total substance-free days (139 days; ranging 0-365 vs. 265; 0-366, p=0.021) - specifically among the patients with drug addiction - and higher physical and mental quality of life (45 vs 58, p= 0.049 and 54 vs. 66, p=0.037), but not in the per-protocol analysis (60 vs. 46, p=0.52 and 70 vs. 66, p=0.74).","['212 patients (intervention, n=113; control, n=99', 'patients diagnosed with alcohol and drug addiction', '322 patients aged 18 years or older were identified, and the study requirements were fulfilled by 219 patients, 7 of whom participated in a pilot', 'patients with alcohol and drug addiction ']","['educational program that included motivational interviewing, a smoking cessation program, dietary and physical activity counseling, and patient education', 'Very Integrated Program (VIP', 'Very Integrated Program (VIP): Health promotion']","['substance-free days, time to relapse and treatment adherence', 'total substance-free days', 'alcohol or drug addiction care or the lifestyle', 'physical and mental quality of life', 'lifestyle factors, symptoms of comorbidity, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1510472', 'cui_str': 'Drug dependence'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}]","[{'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1510472', 'cui_str': 'Drug dependence'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",322.0,0.0700003,"At the 12-month follow-up, the patients in the control group had significantly more total substance-free days (139 days; ranging 0-365 vs. 265; 0-366, p=0.021) - specifically among the patients with drug addiction - and higher physical and mental quality of life (45 vs 58, p= 0.049 and 54 vs. 66, p=0.037), but not in the per-protocol analysis (60 vs. 46, p=0.52 and 70 vs. 66, p=0.74).","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hovhannisyan', 'Affiliation': 'Clinical Health Promotion Centre, WHO-CC, Region Skåne and Dept of Health Science, Lund University, Lund, Sweden.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'Clinical Health Promotion Centre, WHO-CC, Region Skåne and Dept of Health Science, Lund University, Lund, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Adami', 'Affiliation': 'Sophiahemmet University, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wikström', 'Affiliation': 'Clinical Health Promotion Centre, WHO-CC, Region Skåne and Dept of Health Science, Lund University, Lund, Sweden.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Tønnesen', 'Affiliation': 'Clinical Health Promotion Centre, WHO-CC, Region Skåne and Dept of Health Science, Lund University, Lund, Sweden.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14364']
2295,32426224,Efficacy of abdominal massage with mastic gum oil on gastroesophageal reflux disease symptoms of infant: a randomized controlled trial.,,2020,,['gastroesophageal reflux disease symptoms of infant'],['abdominal massage with mastic gum oil'],[],"[{'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C2316341', 'cui_str': 'Massage of abdomen'}, {'cui': 'C0164196', 'cui_str': 'Gum Mastic'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]",[],,0.0739879,,"[{'ForeName': 'Hoorieh Mohammadi', 'Initials': 'HM', 'LastName': 'Kenari', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mansureh', 'Initials': 'M', 'LastName': 'Akhavan', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Sadeghian', 'Affiliation': 'Department of Pediatric Gastroenterology, Children Medical Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghobadi', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahrbanoo', 'Initials': 'S', 'LastName': 'Nakhaie', 'Affiliation': 'Associate professor Pediatric gastroenterologist, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rampisheh', 'Affiliation': 'Preventive Medicine and Public Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Khalessi', 'Affiliation': 'Department of Neonatology Ali Asghar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}]",Integrative medicine research,['10.1016/j.imr.2020.02.004']
2296,32425160,Longitudinal assessment of carotid plaque texture in three-dimensional ultrasound images based on semi-supervised graph-based dimensionality reduction and feature selection.,"With continuous development of therapeutic options for atherosclerosis, image-based biomarkers sensitive to the effect of new interventions are required to be developed for cost-effective clinical evaluation. Although 3D ultrasound measurement of total plaque volume (TPV) showed the efficacy of high-dose statin, more sensitive biomarkers are needed to establish the efficacy of dietary supplements expected to confer a smaller beneficial effect. This study involved 171 subjects who participated in a one-year placebo-controlled trial evaluating the effect of pomegranate. A framework involving a feature selection technique known as discriminative feature selection (DFS) and a semi-supervised graph-based regression (SSGBR) technique was proposed for sensitive detection of plaque textural changes over the trial. 376 textual features of plaques were extracted from 3D ultrasound images acquired at baseline and a follow-up session. A scalar biomarker for each subject were generated by SSGBR based on prominent textural features selected by DFS. The ability of this biomarker for discriminating pomegranate from placebo subjects was quantified by the p-values obtained in Mann-Whitney U test. The discriminative power of SSGBR was compared with global and local dimensionality reduction techniques, including linear discriminant analysis (LDA), maximum margin criterion (MMC) and Laplacian Eigenmap (LE). Only SSGBR (p=4.12×10 -6 ) and normalized LE (p=0.002) detected a difference between the two groups at the 5% significance level. As compared with ΔTPV, SSGBR reduced the sample size required to establish a significant difference by a factor of 60. The application of this framework will substantially reduce the cost incurred in clinical trials.",2020,Only SSGBR (p=4.12×10 -6 ) and normalized LE (p=0.002) detected a difference between the two groups at the 5% significance level.,['171 subjects who participated in a one-year'],['placebo'],"['linear discriminant analysis (LDA), maximum margin criterion (MMC) and Laplacian Eigenmap (LE', 'normalized LE']","[{'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0012630', 'cui_str': 'Discriminant Analysis'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",376.0,0.0386513,Only SSGBR (p=4.12×10 -6 ) and normalized LE (p=0.002) detected a difference between the two groups at the 5% significance level.,"[{'ForeName': 'Mingquan', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Electrical Engineering, City University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'Department of Electrical Engineering, City University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Weifu', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'School of Mathematics, Sun Yat-sen University, Guangzhou, China; Department of Electrical Engineering, City University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Arna', 'Initials': 'A', 'LastName': 'van Engelen', 'Affiliation': 'Biomedical Imaging Group Rotterdam, Departments of Radiology and Nuclear Medicine, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'de Bruijne', 'Affiliation': 'Biomedical Imaging Group Rotterdam, Departments of Radiology and Nuclear Medicine, Erasmus MC, Rotterdam, The Netherlands; Machine Learning Section, Department of Computer Science, University of Copenhagen, Denmark.'}, {'ForeName': 'M Reza', 'Initials': 'MR', 'LastName': 'Azarpazhooh', 'Affiliation': 'Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Seyed Mojtaba', 'Initials': 'SM', 'LastName': 'Sohrevardi', 'Affiliation': 'Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute, London, Ontario, Canada; Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Spence', 'Affiliation': 'Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chiu', 'Affiliation': 'Department of Electrical Engineering, City University of Hong Kong, Hong Kong, China. Electronic address: bcychiu@cityu.edu.hk.'}]",Computers in biology and medicine,['10.1016/j.compbiomed.2019.103586']
2297,32425216,A Propensity Score Method for Investigating Differential Item Functioning in Performance Assessment.,"This study introduces a novel differential item functioning (DIF) method based on propensity score matching that tackles two challenges in analyzing performance assessment data, that is, continuous task scores and lack of a reliable internal variable as a proxy for ability or aptitude. The proposed DIF method consists of two main stages. First, propensity score matching is used to eliminate preexisting group differences before the test, ideally creating equivalent groups as in a randomized experimental study. Then, linear mixed effects models are adopted to perform DIF analysis based on the matched data set. We demonstrate this propensity DIF method using a high-stakes functional English language proficiency test. DIF due to education was investigated in the writing component, which consists of two continuously scored performance-based tasks. Although the proposed method is demonstrated in the context of language testing, it can be applied to other types of performance assessments.",2020,"Although the proposed method is demonstrated in the context of language testing, it can be applied to other types of performance assessments.",[],[],[],[],[],[],2.0,0.0272002,"Although the proposed method is demonstrated in the context of language testing, it can be applied to other types of performance assessments.","[{'ForeName': 'Michelle Y', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Paragon Testing Enterprises, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Bruno D', 'Initials': 'BD', 'LastName': 'Zumbo', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}]",Educational and psychological measurement,['10.1177/0013164419878861']
2298,32425361,"Efficacy and Safety of Lianhuaqingwen Capsules, a repurposed Chinese Herb, in Patients with Coronavirus disease 2019: A multicenter, prospective, randomized controlled trial.","Background


Coronavirus disease 2019 (Covid-19) has resulted in a global outbreak. Few existing targeted medications are available. Lianhuaqingwen (LH) capsule, a repurposed marketed Chinese herb product, has been proven effective for influenza.
Purpose


To determine the safety and efficacy of LH capsule in patients with Covid-19.
Methods


We did a prospective multicenter open-label randomized controlled trial on LH capsule in confirmed cases with Covid-19. Patients were randomized to receive usual treatment alone or in combination with LH capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery.
Results


We included 284 patients (142 each in treatment and control group) in the full-analysis set. The recovery rate was significantly higher in treatment group as compared with control group (91.5% vs. 82.4%,  P =0.022). The median time to symptom recovery was markedly shorter in treatment group (median: 7 vs. 10 days,  P <0.001). Time to recovery of fever (2 vs. 3 days), fatigue (3 vs. 6 days) and coughing (7 vs. 10 days) was also significantly shorter in treatment group (all  P <0.001). The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%,  P <0.001) and clinical cure (78.9% vs. 66.2%,  P= 0.017) was also higher in treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings (both  P >0.05). No serious adverse events were reported.
Conclusion


In light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19.",2020,"The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%,  P <0.001) and clinical cure (78.9% vs. 66.2%,  P= 0.017) was also higher in treatment group.","['patients with Covid-19', '284 patients (142 each in treatment and control group) in the full-analysis set', 'Patients with Coronavirus disease 2019']","['LH capsule', 'Lianhuaqingwen Capsules, a repurposed Chinese Herb', 'usual treatment alone or in combination with LH capsules']","['Efficacy and Safety', 'rate of improvement in chest computed tomographic manifestations', 'coughing', 'Time to recovery of fever', 'fatigue', 'rate of symptom (fever, fatigue, coughing) recovery', 'rate of conversion to severe cases or viral assay findings', 'clinical cure', 'safety and efficacy', 'serious adverse events', 'median time to symptom recovery', 'recovery rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C3852361', 'cui_str': 'lianhuaqingwen'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",284.0,0.213016,"The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%,  P <0.001) and clinical cure (78.9% vs. 66.2%,  P= 0.017) was also higher in treatment group.","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan 430060, Hubei province, China.'}, {'ForeName': 'Wei-Jie', 'Initials': 'WJ', 'LastName': 'Guan', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province,510120, P.R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Bi', 'Affiliation': 'Department of Gynaecology and Obstetrics, Wuhan Red Cross Hospital, 392 Hongkong Road, Wuhan 430015, Hubei province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Lanjuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of College of Medicine, Zhejiang province, China.'}, {'ForeName': 'Boli', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'The First Teaching Hospital of Tianjin University of traditional Chinese medicine.'}, {'ForeName': 'Qingquan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Beijing Hospital of traditional Chinese medicine, Beijing, China.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Zhongshan Hospital Affiliated Fudan University, Shanghai, China.'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Beijing Ditan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhongping', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Youan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Qingshan', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Shanghai University of traditional Chinese medicine, Shanghai, China.'}, {'ForeName': 'Zifeng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province,510120, P.R. China.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province,510120, P.R. China.'}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ""Fuyang Second People's Hospital, Fuyang, China.""}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'Wuhan Jinyintan Hospital, Wuhan, Hubei province, China.'}, {'ForeName': 'Chaomin', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Zhongshan Hospital Affiliated Fudan University, Shanghai, China.'}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan 430060, Hubei province, China.'}, {'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Jia', 'Affiliation': 'Hebei Yiling Hospital, National Key Laboratory of Collateral Disease Research and Innovative Chinese Medicine, Shijiazhuang, Hebei province 050035, P.R China.'}, {'ForeName': 'Nan-Shan', 'Initials': 'NS', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province,510120, P.R. China.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153242']
2299,32425736,"A 12-week, randomized, double-blind study to evaluate the efficacy and safety of liver function after using fermented ginseng powder (GBCK25).","Background


Recently, clinical research has suggested that red ginseng components play a role in liver protection and combating fatigue. However, fermented ginseng has not been analyzed for liver-protective or anti-fatigue effects.
Objective


This study evaluates the positive effects of fermented ginseng powder (GBCK25) on liver function.
Methods


Ninety participants with elevated alanine aminotransferase levels (35 ≤ ALT ≤1 05 IU/L) were randomized to one of three groups. The participants were treated with GBCK25 tablets at a dose of 500 mg/day (high dose), 125 mg/day (low dose), or placebo group daily for 12 weeks. The primary outcomes included changes in ALT and gamma-glutamyl transferase (GGT) levels. The secondary outcomes included changes in aspartate amino-transferase (AST), high-sensitivity C-reactive protein (hs-CRP), multidimensional fatigue scale, lipid profile, and antioxidant markers.
Results


In male subjects, after 12 weeks of low-dose GBCK25 (125 mg) supplementation, the GGT ( P  = 0.036) and hs-CRP ( P  = 0.021) levels decreased significantly more than those in the placebo group. High-dose GBCK25 (500 mg) supplementation significantly decreased the fatigue score compared with the placebo group. There were no clinically significant differences between the groups when studying any safety parameter.
Conclusion


Our results suggest that GBCK25 supplementation has beneficial effects on liver function.
Trial registration


This study was registered at Clinical Trials.gov (NCT03260543).",2020,"There were no clinically significant differences between the groups when studying any safety parameter.
",['Ninety participants with elevated alanine aminotransferase levels (35 ≤ ALT ≤1 05 IU/L'],"['fermented ginseng powder (GBCK25', 'GBCK25 tablets', 'fermented ginseng', 'GBCK25 supplementation', 'High-dose GBCK25', 'GBCK25', 'placebo']","['changes in aspartate amino-transferase (AST), high-sensitivity C-reactive protein (hs-CRP), multidimensional fatigue scale, lipid profile, and antioxidant markers', 'efficacy and safety of liver function', 'fatigue score', 'changes in ALT and gamma-glutamyl transferase (GGT) levels']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}]","[{'cui': 'C0086767', 'cui_str': 'Ginseng'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0040676', 'cui_str': 'Transferase'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",90.0,0.52995,"There were no clinically significant differences between the groups when studying any safety parameter.
","[{'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Jung', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Soo-Hyun', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Eun-Kyung', 'Initials': 'EK', 'LastName': 'Choi', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Ki-Chan', 'Initials': 'KC', 'LastName': 'Ha', 'Affiliation': 'Healthcare Claims & Management Incorporation, Jeonju, Republic of Korea.'}, {'ForeName': 'Hyang-Im', 'Initials': 'HI', 'LastName': 'Baek', 'Affiliation': 'Healthcare Claims & Management Incorporation, Jeonju, Republic of Korea.'}, {'ForeName': 'Dong-Gue', 'Initials': 'DG', 'LastName': 'Shin', 'Affiliation': 'Research & Development Center of GENERAL BIO Co., Ltd, Namwon, Jeollabuk-Do, Republic of Korea.'}, {'ForeName': 'Jeong-Hun', 'Initials': 'JH', 'LastName': 'Seo', 'Affiliation': 'Research & Development Center of GENERAL BIO Co., Ltd, Namwon, Jeollabuk-Do, Republic of Korea.'}, {'ForeName': 'Soo-Wan', 'Initials': 'SW', 'LastName': 'Chae', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}]",Food & nutrition research,['10.29219/fnr.v64.3517']
2300,32425851,"Swearing as a Response to Pain: Assessing Hypoalgesic Effects of Novel ""Swear"" Words.","Previous research showing that swearing alleviates pain is extended by addressing emotion arousal and distraction as possible mechanisms. We assessed the effects of a conventional swear word (""fuck"") and two new ""swear"" words identified as both emotion-arousing and distracting: ""fouch"" and ""twizpipe."" A mixed sex group of participants ( N  = 92) completed a repeated measures experimental design augmented by mediation analysis. The independent variable was repeating one of four different words: ""fuck"" vs. ""fouch"" vs. ""twizpipe"" vs. a neutral word. The dependent variables were emotion rating, humor rating, distraction rating, cold pressor pain threshold, cold pressor pain tolerance, pain perception score, and change from resting heart rate. Mediation analyses were conducted for emotion, humor, and distraction ratings. For conventional swearing (""fuck""), confirmatory analyses found a 32% increase in pain threshold and a 33% increase in pain tolerance, accompanied by increased ratings for emotion, humor, and distraction, relative to the neutral word condition. The new ""swear"" words, ""fouch"" and ""twizpipe,"" were rated as more emotional and humorous than the neutral word but did not affect pain threshold or tolerance. Changes in heart rate and pain perception were absent. Our data replicate previous findings that repeating a swear word at a steady pace and volume benefits pain tolerance, extending this finding to pain threshold. Mediation analyses did not identify a pathway via which such effects manifest. Distraction appears to be of little importance but emotion arousal is worthy of future study.",2020,Changes in heart rate and pain perception were absent.,['A mixed sex group of participants ( N  = 92'],"['fuck"" vs. ""fouch"" vs. ""twizpipe"" vs. a neutral word', 'conventional swear word (""fuck"") and two new ""swear"" words identified as both emotion-arousing and distracting: ""fouch"" and ""twizpipe']","['emotion rating, humor rating, distraction rating, cold pressor pain threshold, cold pressor pain tolerance, pain perception score, and change from resting heart rate', 'ratings for emotion, humor, and distraction, relative to the neutral word condition', 'pain threshold', 'heart rate and pain perception', 'pain tolerance']","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0233730', 'cui_str': 'Swearing'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0020168', 'cui_str': 'Humor'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0253879,Changes in heart rate and pain perception were absent.,"[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stephens', 'Affiliation': 'School of Psychology, Keele University, Keele, United Kingdom.'}, {'ForeName': 'Olly', 'Initials': 'O', 'LastName': 'Robertson', 'Affiliation': 'School of Psychology, Keele University, Keele, United Kingdom.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00723']
2301,32425877,Natural Variation of Vitamin D and Neurofilament Light Chain in Relapsing-Remitting Multiple Sclerosis.,"Background:  High serum levels of 25-hydroxyvitamin D (25(OH)D) have been found among patients with a favorable disease course in relapsing-remitting MS (RRMS), indicating that this may limit clinical deterioration. Clinical deterioration in RRMS correlates with increasing serum levels of neurofilament light chain (NfL).  Objectives:  To examine the association between physiological variations in serum 25(OH)D and NfL levels in RRMS patients before and during disease modifying therapy (DMT).  Material and Methods:  Serum 25(OH)D and NfL concentrations were measured in 85 newly diagnosed RRMS patients enrolled in a 24-month randomized double-blinded placebo-controlled trial of ω-3 fatty acid supplementation without vitamin D. Patients were without DMT until interferon β-1a (IFN-β) initiation at study month 6. Longitudinal serum measurements and brain magnetic resonance imaging (MRI) were obtained. Associations between 25(OH)D and NfL levels were analyzed with linear regression models for the whole study period and the periods before and during IFN-β treatment. Analyses with adjustment for inflammatory MRI disease activity were also performed.  Results:  No significant associations were found between variations in 25(OH)D and NfL levels during the whole study period ( p  = 0.95), or the periods without ( p  = 0.78) or with ( p  = 0.33) IFN-β therapy. Patients with inflammatory MRI disease activity had significantly higher serum NfL levels than patients without inflammatory MRI disease activity [mean (SD) difference 12.6 (2.0) pg/mL,  p  < 0.01]. Adjustment for this did not change the relationship between 25(OH)D and NfL concentrations.  Conclusion:  Natural variations in serum 25(OH)D values do not seem to be associated with alterations in serum NfL concentrations in RRMS patients.",2020,"Patients with inflammatory MRI disease activity had significantly higher serum NfL levels than patients without inflammatory MRI disease activity [mean (SD) difference 12.6 (2.0) pg/mL,  p  < 0.01].","['Relapsing-Remitting Multiple Sclerosis', 'patients with a favorable disease course in relapsing-remitting MS (RRMS', '85 newly diagnosed RRMS patients enrolled', 'RRMS patients before and during disease modifying therapy (DMT']","['Vitamin D and Neurofilament Light Chain', '25-hydroxyvitamin D (25(OH)D', 'ω-3 fatty acid supplementation without vitamin D', 'placebo']","['Longitudinal serum measurements and brain magnetic resonance imaging (MRI', '25(OH)D and NfL levels', 'inflammatory MRI disease activity', 'Serum 25(OH)D and NfL concentrations', 'serum 25(OH)D values', 'serum NfL levels', 'serum 25(OH)D and NfL levels']","[{'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027183', 'cui_str': 'N,-N-dimethyltryptamine'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",85.0,0.0822804,"Patients with inflammatory MRI disease activity had significantly higher serum NfL levels than patients without inflammatory MRI disease activity [mean (SD) difference 12.6 (2.0) pg/mL,  p  < 0.01].","[{'ForeName': 'Egil', 'Initials': 'E', 'LastName': 'Røsjø', 'Affiliation': 'Volvat Medical Center, Oslo, Norway.'}, {'ForeName': 'Jonas C', 'Initials': 'JC', 'LastName': 'Lindstrøm', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Holmøy', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kjell-Morten', 'Initials': 'KM', 'LastName': 'Myhr', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Kristin N', 'Initials': 'KN', 'LastName': 'Varhaug', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Torkildsen', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}]",Frontiers in neurology,['10.3389/fneur.2020.00329']
2302,32426039,"Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE.","Introduction


We report safety and efficacy in patients treated with dimethyl fumarate (DMF) for ~9 years in ENDORSE. Lymphocyte analysis data are also reported.
Methods


Incidence of serious adverse events (SAEs), discontinuations due to adverse events (AEs), annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS) score were assessed. Patients were treated with DMF 240 mg twice daily (BID): placebo (PBO)/DMF (PBO for years 0-2 /DMF for years 3-9) or continuous (DMF/DMF) treatment; newly diagnosed patients were included. Annual magnetic resonance imaging (MRI) was evaluated in patients from the MRI cohort of DEFINE/CONFIRM. For the lymphocyte analysis, data from first DMF exposure were analyzed.
Results


Of 2079 DEFINE/CONFIRM completers, 1736 enrolled and received ⩾1 dose of DMF. The MRI cohort included 530 patients. In the overall population, 527 (30%) patients experienced SAEs; most were fall and urinary tract infection. Over 9 years on DMF treatment, adjusted ARR remained low (⩽0.20). In patients treated with PBO in years 0-2, decreased ARR was apparent as early as year 3. Of DMF/DMF and PBO/DMF patients, 73% and 74%, respectively, had no 24-week confirmed disability progression. Most patients (~70%) had no new T1 or new/newly enlarging T2 lesions compared with previous MRI scans after 7 years treatment with DMF; the annual number of new T1 hypointense lesions and new/newly enlarging T2 hyperintense lesions were 0.6-0.8 and 0.9-2.0, respectively. Mean percentage brain volume change from ENDORSE baseline (6 years treatment in ENDORSE) was -1.32% (range -1.60% to -1.05%). Of the 2513 patients with lymphocyte assessments, 2470 had ⩾1 post-baseline measurement, 53 developed severe prolonged lymphopenia and were followed for up to 11 years; incidence of serious infection was not higher than in patients with absolute lymphocyte count (ALC) always ⩾ lower limit of normal (LLN). In patients with lymphopenia while on DMF and ALC < 0.91 × 10 9 /L at discontinuation ( n  = 138), median time to ALC ⩾ LLN was 7 weeks post-discontinuation.
Conclusions


Sustained safety and efficacy of DMF was observed in patients continuing on treatment for up to 11 years, supporting DMF as a long-term treatment option for patients with RRMS.
Trial registration


ClinicalTrials.gov identifiers, NCT00835770 (ENDORSE); NCT00420212 (DEFINE); NCT00451451 (CONFIRM).",2020,Mean percentage brain volume change from ENDORSE baseline (6 years treatment in ENDORSE) was -1.32% (range -1.60% to -1.05%).,"['treatment; newly diagnosed patients were included', 'patients treated with', '530 patients', 'patients with relapsing-remitting multiple sclerosis']","['dimethyl fumarate (DMF', 'delayed-release dimethyl fumarate', 'DMF 240 mg twice daily (BID): placebo (PBO)/DMF (PBO for years 0-2 /DMF for years 3-9) or continuous (DMF/DMF', 'Annual magnetic resonance imaging (MRI', 'DMF']","['median time to ALC\u2009⩾\u2009LLN', 'Mean percentage brain volume change', 'safety and efficacy', 'Safety and efficacy', 'disability progression', 'annual number of new T1 hypointense lesions and new/newly enlarging T2 hyperintense lesions', 'severe prolonged lymphopenia', 'serious infection', 'ARR', 'serious adverse events (SAEs), discontinuations due to adverse events (AEs), annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS) score']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]","[{'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C3556566', 'cui_str': 'dimethyl fumarate 240 MG [Tecfidera]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2513.0,0.0407799,Mean percentage brain volume change from ENDORSE baseline (6 years treatment in ENDORSE) was -1.32% (range -1.60% to -1.05%).,"[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gold', 'Affiliation': 'Department of Neurology, St. Josef-Hospital, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Montreal Neurological Institute, McGill University and NeuroRx Research, Montreal, QC, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bar-Or', 'Affiliation': 'Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Fox', 'Affiliation': 'Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University, Basel, Switzerland.'}, {'ForeName': 'Chongshu', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Parks', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Biogen, 225 Binney Street, Cambridge, MA 02142, USA.'}]",Therapeutic advances in neurological disorders,['10.1177/1756286420915005']
2303,32426152,Older adults' experiences of using a wearable activity tracker with health professional feedback over a 12-month randomised controlled trial.,"Objective


Wearable activity trackers can help older adults remain physically active. However, knowledge of the user experience during long-term use is scarce. Therefore, this study examined older adults' experiences with, and perceptions of, wearable activity trackers combined with health professional feedback after a year's use as part of a randomised controlled trial.
Methods


Twenty older adults (73.6 ± 5.5 years) who had used a Jawbone UP24 activity tracker for 12 months during a randomised controlled trial were recruited for this study. All participants had at least one chronic condition. Acceptability data relating to activity tracker wear time was combined with focus group data to explore participants experiences of long-term activity tracker use. Data was analysed using thematic analysis.
Results


The activity tracker was well-accepted with the device worn on an average of 86% of possible days and participants reported an overall positive experience. Four themes were identified: (a) increased sense of awareness of activity levels is related to motivation; (b) the level of engagement with the activity tracker influences the user experience; (c) the role of feedback from a health professional in providing ongoing support; d) the role of habits in supporting long-term behaviour change.
Conclusions


The use of an activity tracker combined with health professional support can assist older adults to maintain their activity levels over 12 months. Consideration should be given to the previous technology experience of users and the design and accuracy of an activity tracker when recommending their use in a research or clinical setting.",2020,The activity tracker was well-accepted with the device worn on an average of 86% of possible days and participants reported an overall positive experience.,"['All participants had at least one chronic condition', 'Twenty older adults (73.6\u2009±\u20095.5 years) who had used a', 'Older adults', 'older adults remain physically active']","['wearable activity trackers combined with health professional feedback', 'activity tracker combined with health professional support', 'wearable activity tracker with health professional feedback', 'Jawbone UP24 activity tracker']","['sense of awareness of activity levels', 'activity tracker']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}]",4.0,0.046266,The activity tracker was well-accepted with the device worn on an average of 86% of possible days and participants reported an overall positive experience.,"[{'ForeName': 'Katie-Jane', 'Initials': 'KJ', 'LastName': 'Brickwood', 'Affiliation': 'School of Health Science, University of Tasmania, Australia.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Williams', 'Affiliation': 'School of Health Science, University of Tasmania, Australia.'}, {'ForeName': 'Greig', 'Initials': 'G', 'LastName': 'Watson', 'Affiliation': 'School of Health Science, University of Tasmania, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': ""O'Brien"", 'Affiliation': 'School of Health Science, University of Tasmania, Australia.'}]",Digital health,['10.1177/2055207620921678']
2304,32424726,"Influence of lower body compression garments on cardiovascular autonomic responses prior to, during and following submaximal cycling exercise.","PURPOSE


The aim of the current study was to examine the impact of lower body compression garments (CG) on cardiac autonomic control of heart rate (HR) prior to, during and following submaximal exercise.
METHODS


Thirty (15 males, 15 females) healthy, active adults undertook consecutive 10-min stages of supine rest, moderate-intensity upright cycling and supine recovery while wearing either normal clothing (CONTROL) or normal clothing plus CG tights in a randomised order. Heart rate (HR) and rating of perceived exertion (RPE) were assessed every minute while cardiovascular autonomic responses were assessed during the final 5 min of each stage via HR variability (HRV). The change in HR at 1-min (HRR1) and 2-min (HRR2) post-exercise and the time constant of HR recovery (HR tau ) were assessed as indices of cardiac autonomic reactivation. Differences between variables were assessed via repeated measures ANOVA and corrected pairwise comparisons.
RESULTS


Compared to rest, exercise resulted in a reduction of HRV that was similar for CONTROL and CG. A main effect for condition was identified for one non-linear, long-term HRV variable only with a significantly lower value (61.4 ± 47.8 vs. 67.1 ± 50.2 ms, p < 0.05) for CG compared to CONTROL. Cardiac autonomic reactivation (HRR1, 42.0 ± 16.8 vs. 45.5 ± 13.4 bpm; HRR2, 58.9 ± 10.5 vs. 58.9 ± 8.2 bpm; HR tau , 63.4 ± 22.3 vs. 65.1 ± 23.0 s, p > 0.05) was comparable for CONTROL and CG.
CONCLUSION


Lower body CG failed to alter most cardiac autonomic responses during rest, moderate-intensity exercise or recovery. Mechanisms for potential ergogenic benefits of CG remain to be characterised.",2020,"HR tau , 63.4 ± 22.3 vs. 65.1 ± 23.0 s, p > 0.05) was comparable for CONTROL and CG.
","['Thirty (15 males, 15 females) healthy, active adults undertook consecutive 10-min stages of']","['supine rest, moderate-intensity upright cycling and supine recovery while wearing either normal clothing (CONTROL) or normal clothing plus CG tights', 'lower body compression garments (CG', 'lower body compression garments']","['cardiac autonomic control of heart rate (HR', 'Heart rate (HR) and rating of perceived exertion (RPE', 'cardiac autonomic responses', 'Cardiac autonomic reactivation', 'cardiovascular autonomic responses', 'cardiac autonomic reactivation', 'change in HR at 1-min (HRR1) and 2-min (HRR2) post-exercise and the time constant of HR recovery (HR tau ']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]",,0.0622575,"HR tau , 63.4 ± 22.3 vs. 65.1 ± 23.0 s, p > 0.05) was comparable for CONTROL and CG.
","[{'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Leicht', 'Affiliation': 'Sport and Exercise Science, James Cook University, Townsville, QLD, 4811, Australia. Anthony.Leicht@jcu.edu.au.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Ahmadian', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Fabio Y', 'Initials': 'FY', 'LastName': 'Nakamura', 'Affiliation': 'Associate Graduate Program in Physical Education UPE/UFPB, João Pessoa, PB, Brazil.'}]",European journal of applied physiology,['10.1007/s00421-020-04391-9']
2305,31303555,Multi-Night Sleep Restriction Impairs Long-Term Retention of Factual Knowledge in Adolescents.,"PURPOSE


Sleep deprivation is associated with increased forgetting of declarative memories. Sleep restriction across multiple consecutive nights is prevalent in adolescents, but questions remain as to whether this pattern of sleep impairs memory for material typically learned in the classroom and the time course of retention beyond a few days.
METHODS


Adolescents aged 15-18 years (n = 29) were given 5 hours sleep opportunity each night for 5 consecutive nights (sleep restricted group; SR), simulating a school week containing insufficient sleep. After the fourth night of restriction, participants learned detailed facts about different species of arthropod across a 6-hour period. Retention was tested 30 minutes and 3 days after learning and contrasted with a control group (n = 30) who had 9 hours sleep opportunity every night of the study. A subset of participants (SR, n = 14; control, n = 22) completed a surprise test 42 days after learning.
RESULTS


Memory was significantly impaired in the SR group relative to controls, with 26% increased forgetting at the 30-minute test (t(57) = 2.54, p = .014, d = .66), 34% at the Day 3 test (t(57) = 2.65, p = .010, d = .69), and 65% at the Day 42 test (t(34) = 3.22, p = .003, d = 1.17). Vigilance was also significantly impaired after 4 nights of restricted sleep (p < .05), but did not correlate significantly with memory (p > .05).
CONCLUSION


Long-term retention of classroom material is significantly compromised when adolescents learn after being sleep restricted, reinforcing the importance of keeping good sleep habits to optimize learning.",2019,"Vigilance was also significantly impaired after four nights of restricted sleep (p < .05), but did not correlate significantly with memory (p > .05).
","['Adolescents aged 15-18\xa0years (n\xa0= 29', 'Adolescents']","['Multi-Night Sleep Restriction', '5\xa0hours sleep opportunity each night for five consecutive nights (sleep restricted group; SR), simulating a school week containing insufficient sleep']","['Vigilance', 'Memory', 'forgetting of declarative memories']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1442467', 'cui_str': '5 hours (qualifier value)'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0300318,"Vigilance was also significantly impaired after four nights of restricted sleep (p < .05), but did not correlate significantly with memory (p > .05).
","[{'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Cousins', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Kian F', 'Initials': 'KF', 'LastName': 'Wong', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Michael W L', 'Initials': 'MWL', 'LastName': 'Chee', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore. Electronic address: michael.chee@duke-nus.edu.sg.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.04.030']
2306,31247661,[French comment on article Endoscopic tissue shielding to prevent bleeding after endoscopic submucosal dissection: a prospective multicenter randomized controlled trial].,,2019,,['after endoscopic submucosal dissection'],['Endoscopic tissue shielding'],['bleeding'],"[{'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}]",,0.0859991,,[],Endoscopy,['10.1055/a-0942-7924']
2307,32425111,Single-dwell treatment with a low-sodium solution in hypertensive peritoneal dialysis patients.,"BACKGROUND


Patients on peritoneal dialysis (PD) may suffer from sodium (Na) and fluid overload, hypertension and increased cardiovascular risk. Low-Na dialysis solution, by increasing the diffusive removal of Na, might improve blood pressure (BP) management.
METHODS


A glucose-compensated, low-Na PD solution (112 mmol/L Na and 2% glucose) was compared to a standard-Na solution (133 mmol/L Na and 1.5% glucose) in a prospective, randomised, single-blind study in hypertensive patients on PD. One daily exchange of the standard dialysis regimen was substituted by either of the study solutions for 6 months. The primary outcome (response) was defined as either a decrease of 24-h systolic BP (SBP) by ≥6 mmHg or a fall in BP requiring a medical intervention (e.g. a reduction of antihypertensive medication) at 8 weeks.
RESULTS


One hundred twenty-three patients were assessed for efficacy. Response criteria were achieved in 34.5% and 29.1% of patients using low- and standard-Na solutions, respectively ( p  = 0.51). Small reductions in 24 h, office, and self-measured BP were observed, more marked with low-Na than with standard-Na solution, but only the between-group difference for self-measured SBP and diastolic BP was significant ( p  = 0.002 and  p  = 0.003). Total body water decreased in the low-Na group and increased in the control group, but between-group differences were not significant. Hypotension and dizziness occurred in 27.0% and in 11.1% of patients in the low-Na group and in 16.9% and 4.6% in the control group, respectively.
CONCLUSIONS


Superiority of low-Na PD solution over standard-Na solution for control of BP could not be shown. The once daily use of a low-Na PD solution was associated with more hypotensive episodes, suggesting the need to reassess the overall concept of how Na-reduced solutions might be incorporated within the treatment schedule.",2020,"Total body water decreased in the low-Na group and increased in the control group, but between-group differences were not significant.","['Patients on peritoneal dialysis (PD', 'One hundred twenty-three patients', 'hypertensive patients on PD', 'hypertensive peritoneal dialysis patients']","['Single-dwell treatment with a low-sodium solution', 'standard-Na solution (133 mmol/L Na and 1.5% glucose', 'low-Na PD solution', 'glucose-compensated, low-Na PD solution (112 mmol/L Na and 2% glucose']","['Total body water', 'self-measured SBP and diastolic BP', 'Small reductions in 24 h, office, and self-measured BP', '24-h systolic BP (SBP', 'blood pressure (BP) management', 'Hypotension and dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0353714', 'cui_str': 'Peritoneal dialysis solution'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",123.0,0.0336869,"Total body water decreased in the low-Na group and increased in the control group, but between-group differences were not significant.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Davies', 'Affiliation': 'Faculty of Medicine and Health Sciences, Keele University, Staffordshire, UK.'}, {'ForeName': 'Börje', 'Initials': 'B', 'LastName': 'Haraldsson', 'Affiliation': 'Department of Physiology, University of Gothenburg, Sweden.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Vrtovsnik', 'Affiliation': 'Department of Nephrology, Xavier Bichat Hospital, Paris, France.'}, {'ForeName': 'Vedat', 'Initials': 'V', 'LastName': 'Schwenger', 'Affiliation': 'Department of Nephrology, Katharinenhospital, Stuttgart, Germany.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Department of Nephrology, The Royal London Hospital, London, UK.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Klein', 'Affiliation': 'Department of Nephrology, Hospital Louis Pasteur, Colmar, France.'}, {'ForeName': 'Saynab', 'Initials': 'S', 'LastName': 'Atiye', 'Affiliation': 'Fresenius Medical Care, Bad Homburg, Germany.'}, {'ForeName': 'Adelheid', 'Initials': 'A', 'LastName': 'Gauly', 'Affiliation': 'Fresenius Medical Care, Bad Homburg, Germany.'}]",Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis,['10.1177/0896860820924136']
2308,32425570,Effects of Two Types of Moderate- and High-Intensity Interval Training on Serum Salusin-α and Salusin-β Levels and Lipid Profile in Women with Overweight/Obesity.,"Objective


The current study aimed to compare the effects of two modes of moderate- and high-intensity interval training on serum Salusin-α and Salusin-β and lipid profile in women with overweight/obesity.
Subjects and Methods


A number of forty females were assigned to each of (1) Control (BMI= 30.2 ± 2.8 kg/m 2 , n=14), (2) Moderate-intensity (BMI= 31.2 ±3.3 kg/m 2 , n=13) and (3) High-intensity interval training (BMI=30.9±3.4 kg/m 2 , n=13) groups. The subjects of experimental groups participated in the selected interval trainings for eight weeks. The first blood sampling was performed within 48 hours prior to the first training session and the second samples were obtained 48 hours after the last training session.
Results


The findings revealed that there were significant increases in Salusin-α (36% vs. 3%; p = 0.001) and high-density lipoprotein levels (7% vs. 5%; P = 0.039), while significant reductions in the levels of Triglyceride (-8% vs. -9%; p= 0.012) and total cholesterol (-1% vs. -8%; P =0.01) levels of moderate- and high-intensity interval training groups, respectively. Also, there were insignificant changes in Salusin-β (-7% vs. -5%; P = 0.108), low-density lipoproteins (-3% vs. -11%; P =0.046) and very-low-density lipoprotein (-10% vs. -8%; P = 0.056) compared to control group. There were only significant differences between Salusin-α and high-density lipoprotein levels of training groups (P<0.05).
Conclusion


It is suggested that, although improvements in lipid profile was nearly similar for two training modes, moderate intensity interval training was more effective to prevent and control atherosclerosis.",2020,", low-density lipoproteins (-3% vs. -11%; P =0.046) and very-low-density lipoprotein (-10% vs. -8%; P = 0.056) compared to control group.","['Subjects and Methods\n\n\nA number of forty females', 'women with overweight/obesity', 'Women with Overweight/Obesity']","['Moderate- and High-Intensity Interval Training', 'moderate-\xa0and high-intensity interval training']","['serum Salusin-α and Salusin-β and lipid profile', 'Salusin-β ', 'total cholesterol', 'Salusin-α and high-density lipoprotein levels', 'Salusin-α', 'levels of Triglyceride', 'very-low-density lipoprotein', 'high-density lipoprotein levels', 'low-density lipoproteins', 'lipid profile', 'Serum Salusin-α and Salusin-β Levels and Lipid Profile']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}]",,0.0200504,", low-density lipoproteins (-3% vs. -11%; P =0.046) and very-low-density lipoprotein (-10% vs. -8%; P = 0.056) compared to control group.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nazari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Vazgen', 'Initials': 'V', 'LastName': 'Minasian', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Hovsepian', 'Affiliation': ""Imam Hossein Children's Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.""}]","Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S248476']
2309,32424833,Atraumatic restorative treatments improve child oral health-related quality of life: A noninferiority randomized controlled trial.,"OBJECTIVES


Management of dental caries under dental general anaesthesia (DGA) in young children improves their quality of life. A randomized controlled trial was undertaken to test the changes in oral health-related quality of life among children treated under a DGA or managed using the Atraumatic Restorative Treatment and Hall crown approaches (ARTs).
METHODS


Children scheduled for a DGA for the management of dental caries after assessment at the Oral Health Centre of Western Australia were invited to participate. Inclusion and exclusion criteria were applied. Child oral health-related quality of life (COHRQoL) was evaluated through the Early Childhood Oral Health Impact Scale (ECOHIS) and the child-specific Caries Impacts and Experiences Questionnaire for Children (CARIES-QC) at baseline and 12 months after consent. The changes in child oral health-related quality of life were analysed on an intention-to-treat basis. Paired t-test and Wilcoxon's matched-pairs rank test were used for within-group comparison and t-test, Mann-Whitney test, and test of proportions for between-group comparisons. Linear regression was used for multivariable analyses of the follow-up scores.
RESULTS


Sixty-five parents/carers agreed to participate and were randomized (Test = 32; Control = 33). Mean age = 4.7 years, SD 1.1; 51% male. At baseline, there were no statistically significant differences in age and sex between the groups; however, the ARTs group reported higher ECOHIS scores. At follow-up, both the ARTs and DGA groups had lower ECOHIS scores (20.7 vs 12.9 and 14.4 vs 13.3, respectively) and CARIES-QC scores (12.6 vs 7.1 and 9.9 vs 8.4, respectively). The within-group differences in the ARTs group were statistically significant while the differences in the DGA group were not, P < .01 and P > .05, respectively. In a linear regression of the follow-up scores, being in the DGA group increased the follow-up scores, but it was no longer statistically significant while baseline impact scores were significantly associated with greater follow-up scores for both the ECOHIS and the CARIES-QC, P < .01.
CONCLUSION


The child oral health-related quality life among children scheduled for dental general anaesthesia improved after receiving minimally invasive, atraumatic restorative treatments of dental caries.",2020,"The child oral health-related quality life among children scheduled for dental general anaesthesia improved after receiving minimally invasive, atraumatic restorative treatments of dental caries.","['children scheduled for dental general anaesthesia improved after receiving minimally invasive, atraumatic restorative treatments of dental caries', 'young children', 'dental caries under dental', 'Mean age\xa0', 'Sixty-five parents/carers agreed to participate and were randomized ', 'children treated under a DGA or managed using the Atraumatic Restorative Treatment and Hall crown approaches (ARTs', 'Children scheduled for a DGA for the management of dental caries after assessment at the Oral Health Centre of Western Australia were invited to participate']","['general anaesthesia (DGA', 'Atraumatic restorative treatments']","['quality of life', 'lower ECOHIS scores', 'child oral health-related quality of life', 'oral health-related quality of life', 'baseline impact scores', 'CARIES-QC scores', 'higher ECOHIS scores', 'Early Childhood Oral Health Impact Scale (ECOHIS) and the child-specific Caries Impacts and Experiences Questionnaire for Children (CARIES-QC', 'Child oral health-related quality of life (COHRQoL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",65.0,0.067343,"The child oral health-related quality life among children scheduled for dental general anaesthesia improved after receiving minimally invasive, atraumatic restorative treatments of dental caries.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Arrow', 'Affiliation': 'Dental Health Services, Perth, WA, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Forrest', 'Affiliation': 'Dental Health Services, Perth, WA, Australia.'}]",Community dentistry and oral epidemiology,['10.1111/cdoe.12539']
2310,32426223,"Comparing the effects of manual acupuncture, electroacupuncture, and transcutaneous electrical nerve stimulation on chronic tinnitus: a randomized controlled trial.","Background


The aim of this study was to investigate the superiority of the effects of manual acupuncture (MA), electroacupuncture (EA), or transcutaneous electrical nerve stimulation (TENS) on chronic consecutive tinnitus.
Methods


Forty-five patients with chronic consecutive tinnitus were allocated into an MA, an EA, or a TENS group at a 1:1:1 ratio. The corresponding patients were treated with MA, EA, or TENS twice a week for 10 sessions (5 weeks). The primary outcome was a change in the tinnitus handicap inventory (THI), and the secondary outcomes were loudness and annoyance of tinnitus, pure-tone audiometry (PTA), and the speech discrimination test. The outcome measures were obtained at baseline, visit 5 (week 3), visit 10 (week 5), and visit 11 (follow-up 4 weeks).
Results


Of the 45 participants, 37 (82.22%) completed the study. There was no difference in the THI score change among the groups at any point. However, the number of participants who had reduced scores of more than 10 points was higher in the EA group than in the TENS or MA groups ( p  = 0.037, Fisher's exact test). There was no significant difference in the loudness and annoyance of tinnitus, PTA, and speech discrimination test findings among the groups.
Conclusion


Among the MA, EA, and TENS groups, there was no significant difference in the effects on the treatment of chronic consecutive tinnitus. However, EA could respond to more patients.
Trial registration


Registered on October 21, 2016 (KCT0002117 by CRIS).",2020,"There was no significant difference in the loudness and annoyance of tinnitus, PTA, and speech discrimination test findings among the groups.
","['chronic tinnitus', 'chronic consecutive tinnitus', 'Methods\n\n\nForty-five patients with chronic consecutive tinnitus', '45 participants, 37 (82.22%) completed the study']","['MA, EA, or TENS', 'MA, an EA, or a TENS', 'manual acupuncture (MA), electroacupuncture (EA), or transcutaneous electrical nerve stimulation (TENS', 'manual acupuncture, electroacupuncture, and transcutaneous electrical nerve stimulation']","['chronic consecutive tinnitus', 'change in the tinnitus handicap inventory (THI), and the secondary outcomes were loudness and annoyance of tinnitus, pure-tone audiometry (PTA), and the speech discrimination test', 'THI score change', 'loudness and annoyance of tinnitus, PTA, and speech discrimination test findings']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0004292', 'cui_str': 'Pure tone audiometry'}, {'cui': 'C0037821', 'cui_str': 'Speech Discrimination Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",45.0,0.0915107,"There was no significant difference in the loudness and annoyance of tinnitus, PTA, and speech discrimination test findings among the groups.
","[{'ForeName': 'Bong Hyun', 'Initials': 'BH', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology and Otolaryngology of Korean Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young Kyun', 'Initials': 'YK', 'LastName': 'Moon', 'Affiliation': 'Department of Ophthalmology and Otolaryngology of Korean Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Min Hee', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology and Otolaryngology of Korean Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Hae Jeong', 'Initials': 'HJ', 'LastName': 'Nam', 'Affiliation': 'Department of Ophthalmology and Otolaryngology of Korean Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}]",Integrative medicine research,['10.1016/j.imr.2020.100409']
2311,32425222,[Repurposing chlorpromazine to treat COVID-19: the reCoVery study].,"OBJECTIVES


The ongoing COVID-19 pandemic has caused approximately 2,350,000 infections worldwide and killed more than 160,000 individuals. In Sainte Anne Hospital (GHU PARIS Psychiatrie & Neuroscience, Paris, France) we have observed a lower incidence of symptomatic forms of COVID-19 among patients than among our clinical staff. This observation led us to hypothesize that psychotropic drugs could have a prophylactic action against SARS-CoV-2 and protect patients from the symptomatic and virulent forms of this infection, since several of these psychotropic drugs have documented antiviral properties. Chlorpromazine (CPZ), a phenothiazine derivative, is also known for its antiviral activity via the inhibition of clathrin-mediated endocytosis. Recent in vitro studies have reported that CPZ exhibits anti-MERS-CoV and anti-SARS-CoV-1 activity.
METHODS


In this context, the ReCoVery study aims to repurpose CPZ, a molecule with an excellent tolerance profile and a very high biodistribution in the saliva, lungs and brain. We hypothesize that CPZ could reduce the unfavorable course of COVID-19 infection among patients requiring respiratory support without the need for ICU care, and that it could also reduce the contagiousness of SARS-CoV-2. For this purpose, we plan a pilot, multicenter, randomized, single blind, controlled, phase III therapeutic trial (standard treatment vs. CPZ + standard treatment).
CONCLUSION


This repurposing of CPZ for its anti-SARS-CoV-2 activity could offer an alternative, rapid strategy to alleviate infection severity. This repurposing strategy also avoids numerous developmental and experimental steps, and could save precious time to rapidly establish an anti-COVID-19 therapy with well-known, limited and easily managed side effects.",2020,"This observation led us to hypothesize that psychotropic drugs could have a prophylactic action against SARS-CoV-2 and protect patients from the symptomatic and virulent forms of this infection, since several of these psychotropic drugs have documented antiviral properties.",[],"['Chlorpromazine (CPZ', 'chlorpromazine', 'phenothiazine derivative', 'CPZ', 'CPZ + standard treatment']",[],[],"[{'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0304370', 'cui_str': 'Phenothiazine derivative'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0585347,"This observation led us to hypothesize that psychotropic drugs could have a prophylactic action against SARS-CoV-2 and protect patients from the symptomatic and virulent forms of this infection, since several of these psychotropic drugs have documented antiviral properties.","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Plaze', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Attali', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France.'}, {'ForeName': 'Anne-Cécile', 'Initials': 'AC', 'LastName': 'Petit', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blatzer', 'Affiliation': 'Institut Pasteur, Experimental Neuropathology Unit, Paris, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Simon-Loriere', 'Affiliation': 'Institut Pasteur, G5 Evolutionary Genomics of RNA Viruses, Paris, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Vinckier', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Cachia', 'Affiliation': 'Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, INSERM, Paris, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Chrétien', 'Affiliation': 'Institut Pasteur, Experimental Neuropathology Unit, Paris, France.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Gaillard', 'Affiliation': 'GHU PARIS Psychiatrie & Neurosciences, site Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France.'}]",L'Encephale,['10.1016/j.encep.2020.05.006']
2312,25420455,In-home fortification with 2.5 mg iron as NaFeEDTA does not reduce anaemia but increases weight gain: a randomised controlled trial in Kenyan infants.,"In-home fortification of infants with micronutrient powders (MNPs) containing 12.5 mg iron may increase morbidity from infections; therefore, an efficacious low-dose iron-containing MNP might be advantageous. Effects of iron-containing MNPs on infant growth are unclear. We assessed the efficacy of a low-iron MNP on iron status and growth and monitored safety in a randomised, controlled, double-blind 1-year trial in 6-month-old infants (n = 287) consuming daily a maize porridge fortified with either a MNP including 2.5 mg iron as NaFeEDTA (MNP + Fe) or the same MNP without iron (MNP - Fe). At baseline, after 6 and 12 months, we determined haemoglobin (Hb), iron status [serum ferritin (SF), soluble transferrin receptor (sTfR) and zinc protoporphyrin (ZPP)], inflammation [C-reactive protein (CRP)] and anthropometrics. We investigated safety using weekly morbidity questionnaires asking for diarrhoea, cough, flu, bloody or mucus-containing stool and dyspnoea, and recorded any other illness. Furthermore, feeding history and compliance were assessed weekly. At baseline, 71% of the infants were anaemic and 22% iron deficient; prevalence of inflammation was high (31% had an elevated CRP). Over the 1 year, Hb increased and SF decreased in both groups, without significant treatment effects of the iron fortification. At end point, the weight of infants consuming MNP + Fe was greater than in the MNP - Fe group (9.9 vs. 9.5 kg, P = 0.038). Mothers of infants in the MNP + Fe group reported more infant days spent with cough (P = 0.003) and dyspnoea (P = 0.0002); there were no significant differences on any other of the weekly morbidity measures. In this study, low-dose iron-containing MNP did not improve infant's iron status or reduce anaemia prevalence, likely because absorption was inadequate due to the high prevalence of infections and the low-iron dose.",2015,"Over the 1 year, Hb increased and SF decreased in both groups, without significant treatment effects of the iron fortification.","['Kenyan infants', '6-month-old infants (n\u2009=\u2009287']","['iron-containing MNPs', 'consuming daily a maize porridge fortified with either a MNP including 2.5\u2009mg iron as NaFeEDTA (MNP\u2009+\u2009Fe) or the same MNP without iron (MNP\u2009-\u2009Fe', 'low-iron MNP', 'low-dose iron-containing MNP']","['anaemic and 22% iron deficient; prevalence of inflammation', 'infant days spent with cough', 'dyspnoea', ""infant's iron status or reduce anaemia prevalence"", 'weight of infants consuming MNP\u2009+\u2009Fe', 'anaemia', 'weight gain', 'SF', 'weekly morbidity measures', 'iron status and growth and monitored safety', 'safety using weekly morbidity questionnaires asking for diarrhoea, cough, flu, bloody or mucus-containing stool and dyspnoea', 'haemoglobin (Hb), iron status [serum ferritin (SF), soluble transferrin receptor (sTfR) and zinc protoporphyrin (ZPP)], inflammation [C-reactive protein (CRP)] and anthropometrics']","[{'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0452575', 'cui_str': 'Porridge (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0357084', 'cui_str': 'sodium feredetate'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble (substance)'}, {'cui': 'C0078791', 'cui_str': 'zinc protoporphyrin'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.307542,"Over the 1 year, Hb increased and SF decreased in both groups, without significant treatment effects of the iron fortification.","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Barth-Jaeggi', 'Affiliation': 'Institute of Food, Nutrition and Health, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Moretti', 'Affiliation': 'Institute of Food, Nutrition and Health, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kvalsvig', 'Affiliation': 'University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Penny A', 'Initials': 'PA', 'LastName': 'Holding', 'Affiliation': 'International Centre for Behavioural Studies, Mombasa, Kenya.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Njenga', 'Affiliation': 'Department of Food, Technology and Nutrition, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Mwangi', 'Affiliation': 'Department of Food, Technology and Nutrition, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Meera K', 'Initials': 'MK', 'LastName': 'Chhagan', 'Affiliation': 'Department of Pediatrics and Child Health, University of KwaZulu-Natal, Pietermaritzburg, South Africa.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lacroix', 'Affiliation': 'Institute of Food, Nutrition and Health, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Zimmermann', 'Affiliation': 'Institute of Food, Nutrition and Health, ETH Zurich, Zurich, Switzerland.'}]",Maternal & child nutrition,['10.1111/mcn.12163']
2313,31389581,Therapy of B-ultrasound-guided puncture for incision infection after total abdominal hysterectomy.,"OBJECTIVE


This paper aims to investigate the clinical efficacy of B-ultrasound-guided puncture in the treatment of incision infection after total abdominal hysterectomy (TAH) and to provide references for the clinical treatment.
PATIENTS AND METHODS


116 patients with uterine incision infection after TAH were selected and randomly divided into the observation group and the control group, with 58 cases in each group. The patients in the control group received an intravenous drip of ceftazidime and tinidazole to prevent infection, and the patients in the observation group received B-ultrasound-guided puncture treatment on the basis of the treatment plan of the control group. The clinical therapeutic effects between the two groups were compared.
RESULTS


The cure rate of excellence in the observation group was 84.48%, and the cure rate in the control group was 53.45%, while the difference between the two groups was statistically significant (p<0.05). The total effective rate in the observation group was 98.28%, and that in the control group was 87.93%, but there was no statistically significant difference between the two groups. The hospital stay was (9.5±1.6) days in the observation group and (12.3±2.1) days in the control group, and the mean hospital stay in the observation group was significantly shorter than that in the control group; the difference between the two groups was statistically significant (p<0.05).
CONCLUSIONS


TAH should be performed on patients when they are in the best physical condition, and strictly according to the operation steps to reduce the duration of surgery. The application of B-ultrasound-guided puncture can effectively improve the excellent recovery rate of the incision infection after TAH and shorten the hospitalization time. It is worth popularizing in clinical practice.",2019,"The cure rate of excellence in the observation group was 84.48%, and the cure rate in the control group was 53.45%, while the difference between the two groups was statistically significant (p<0.05).",['116 patients with uterine incision infection after TAH'],"['B-ultrasound-guided puncture', 'intravenous drip of ceftazidime and tinidazole', 'B-ultrasound-guided puncture treatment', 'total abdominal hysterectomy (TAH']","['hospital stay', 'cure rate', 'mean hospital stay', 'clinical therapeutic effects', 'cure rate of excellence', 'total effective rate']","[{'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C1621368', 'cui_str': 'Intravenous Drip'}, {'cui': 'C0007559', 'cui_str': 'Ceftazidime'}, {'cui': 'C0040263', 'cui_str': 'Tinidazole'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0404079', 'cui_str': 'Total abdominal hysterectomy (procedure)'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1527144'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",116.0,0.021288,"The cure rate of excellence in the observation group was 84.48%, and the cure rate in the control group was 53.45%, while the difference between the two groups was statistically significant (p<0.05).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Functional Division, Gansu Maternal and Child Health Care Center, Lanzhou, China. 843758734@qq.com.'}, {'ForeName': 'J-N', 'Initials': 'JN', 'LastName': 'Jing', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Y-Y', 'Initials': 'YY', 'LastName': 'Zhang', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201908_18636']
2314,32426108,Spironolactone in pulmonary arterial hypertension: results of a cross-over study.,"The renin-angiotensin-aldosterone system is implicated in the pathophysiology of pulmonary arterial hypertension. We undertook this study to determine the effects of spironolactone, a mineralocorticoid receptor blocker, on collagen metabolism in pulmonary arterial hypertension patients. After obtaining institutional review board approval and informed consent, 42 pulmonary arterial hypertension patients were prospectively enrolled and 35 patients completed the 16-week randomized double-blinded crossover clinical trial. Subjects received 50 mg spironolactone or placebo and at the end of week 8, treatment arm was switched. Circulating levels of collagen biomarkers, brain natriuretic peptide, and aldosterone levels were measured, and six-minute walk distance, liver function tests, and echocardiogram data were collected at weeks 0, 8, and 16. Mean age was 45 ± 15 years and 87% were females. At baseline, brain natriuretic peptide and aldosterone levels were 74 ± 95 pg/ml and 7 ± 8 pg/ml, respectively. There was no change in the levels of amino-terminal propeptide of procollagen type III (PIIINP), MMP-9, TIMP-1, and MMP-9/TIMP-1 ratio at weeks 8 and 16 compared to baseline values in placebo arm and treatment arm. The baseline six-min walk distance was 436 ± 115 meters at baseline and no change in walk distance was noted at weeks 8 and 16 ( P  = 0.372). None of the patients developed hyperkalemia or liver function test abnormalities at weeks 8 and 16 requiring discontinuation of study drug. Our study showed no change in collagen metabolite levels in pulmonary arterial hypertension patients treated with spironolactone. Spironolactone was safe and well tolerated by pulmonary arterial hypertension patients with no increased hyperkalemia or liver function test abnormalities.",2020,Spironolactone was safe and well tolerated by pulmonary arterial hypertension patients with no increased hyperkalemia or liver function test abnormalities.,"['pulmonary arterial hypertension patients treated with', 'pulmonary arterial hypertension patients', 'Mean age was 45\u2009±\u200915 years and 87% were females', '42 pulmonary arterial hypertension patients were prospectively enrolled and 35 patients', 'pulmonary arterial hypertension']","['spironolactone', 'Spironolactone', 'spironolactone or placebo', 'spironolactone, a mineralocorticoid receptor blocker', 'placebo']","['levels of amino-terminal propeptide of procollagen type III (PIIINP), MMP-9, TIMP-1, and MMP-9/TIMP-1 ratio', 'walk distance', 'six-minute walk distance, liver function tests, and echocardiogram data', 'brain natriuretic peptide and aldosterone levels', 'safe and well tolerated', 'collagen metabolite levels', 'Circulating levels of collagen biomarkers, brain natriuretic peptide, and aldosterone levels', 'hyperkalemia or liver function test abnormalities']","[{'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0066563', 'cui_str': 'Mineralocorticoid Receptor'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0033240', 'cui_str': 'Procollagen Type III'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0145947', 'cui_str': 'Tissue inhibitor of metalloproteinases 1'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",,0.226598,Spironolactone was safe and well tolerated by pulmonary arterial hypertension patients with no increased hyperkalemia or liver function test abnormalities.,"[{'ForeName': 'Zeenat', 'Initials': 'Z', 'LastName': 'Safdar', 'Affiliation': 'Division of Pulmonary-Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Adaani', 'Initials': 'A', 'LastName': 'Frost', 'Affiliation': 'Division of Pulmonary-Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Arya', 'Initials': 'A', 'LastName': 'Basant', 'Affiliation': 'Division of Cardiology, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Deswal', 'Affiliation': 'Division of Cardiology, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': ""O'Brian Smith"", 'Affiliation': 'Division of Pediatrics, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Entman', 'Affiliation': 'Division of Cardiology, Baylor College of Medicine, Houston, TX, USA.'}]",Pulmonary circulation,['10.1177/2045894019898030']
2315,25521188,Comparison of methods to assess adherence to small-quantity lipid-based nutrient supplements (SQ-LNS) and dispersible tablets among young Burkinabé children participating in a community-based intervention trial.,"Adherence to supplementation provided during an intervention trial can affect interpretation of study outcomes. We compared different approaches for estimating adherence to small-quantity lipid-based nutrient supplements (SQ-LNS) and dispersible tablets in a randomised clinical trial in Burkina Faso. A total of 2435 children (9-18 months) were randomly assigned to receive daily 20 g SQ-LNS with varying contents of zinc and a dispersible tablet containing 0 or 5 mg zinc. Adherence to SQ-LNS and tablets was assessed for all children through weekly caregiver interviews, and disappearance rate was calculated based on empty and unused packages returned during home visits. Additional adherence data were collected in different randomly selected subgroups of children: 12-h home observations were completed for children 11 and 16 months of age (n = 192) to assess consumption of SQ-LNS and dispersible tablets, and plasma zinc concentration was measured at baseline and 18 months (n = 310). Apparent adherence to SQ-LNS and dispersible tablets differed according to the assessment method used. Average daily caregiver-reported adherence to both SQ-LNS and dispersible tablets was 97 ± 6%. Disappearance rates showed similarly high average weekly adherence (98 ± 4%). In contrast, only 63% and 54% of children at 11 and 16 months, respectively, received SQ-LNS during the 12-h home observation periods, and fewer (32% and 27%) received a tablet. The lack of change in plasma zinc concentration after 9 months of supplementation suggests low adherence to the zinc tablet. Better methods are needed to assess adherence in community-based supplementation trials.",2015,Disappearance rates showed similarly high average weekly adherence (98 ± 4%).,"['young Burkinabé children participating in a community-based intervention trial', '2435 children (9-18 months']","['small-quantity lipid-based nutrient supplements (SQ-LNS) and dispersible tablets', 'daily 20\u2009g SQ-LNS with varying contents of zinc and a dispersible tablet containing 0 or 5\u2009mg zinc']","['disappearance rate', 'consumption of SQ-LNS and dispersible tablets, and plasma zinc concentration', 'Disappearance rates', 'plasma zinc concentration']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0856204'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",2435.0,0.338063,Disappearance rates showed similarly high average weekly adherence (98 ± 4%).,"[{'ForeName': 'Souheila', 'Initials': 'S', 'LastName': 'Abbeddou', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Sonja Y', 'Initials': 'SY', 'LastName': 'Hess', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Yakes Jimenez', 'Affiliation': 'Nutrition/Dietetics Program, Departments of Individual, Family and Community Education and Family and Community Medicine, University of New Mexico, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Jérôme W', 'Initials': 'JW', 'LastName': 'Somé', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Vosti', 'Affiliation': 'Department of Agricultural & Resource Economics, University of California, Davis, California, USA.'}, {'ForeName': 'Rosemonde M', 'Initials': 'RM', 'LastName': 'Guissou', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Jean-Bosco', 'Initials': 'JB', 'LastName': 'Ouédraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Brown', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, California, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12162']
2316,32425062,The predictive value of procalcitonin in ventilator-associated pneumonia after cardiac valve replacement.,"This study aimed to evaluate the predictive value of procalcitonin (PCT) in ventilator-associated pneumonia (VAP) after cardiac valve replacement. A total of 80 patients who underwent cardiac valve replacement in our department were enrolled in this study. Of these patients,40 were diagnosed with VAP and assigned to the observation group, while the other 40 patients not diagnosed with VAP were assigned to the control group. The changes in serum PCT, white blood cell count and C-reactive protein (CRP) were observed before each operation (T0), on the first day after the operation (T1), the second day after the operation (T2) and the third day after the operation (T3). After the operation, the serum PCT in the observation group was significantly higher than those at different time points after the operation, and also significantly higher than those in the control group ( p  < .05). In the control group, PCT was significantly higher after the operation than before the operation ( p  < .05), but the differences among the different postoperative time points were not statistically significant ( p  > .05). In the two groups, the white blood cell count and CRP were significantly higher after the operation than before the operation ( p  < .05), but the differences between the two groups were not statistically significant ( p  > .05). Serum PCT is an early, sensitive and highly specific high-risk monitoring index and has an early prediction value for VAP after cardiac valve replacement.",2020,"Serum PCT is an early, sensitive and highly specific high-risk monitoring index and has an early prediction value for VAP after cardiac valve replacement.","['ventilator-associated pneumonia (VAP) after cardiac valve replacement', '80 patients who underwent cardiac valve replacement in our department were enrolled in this study', '40 patients not diagnosed with VAP', 'ventilator-associated pneumonia after cardiac valve replacement']",['procalcitonin (PCT'],"['serum PCT', 'serum PCT, white blood cell count and C-reactive protein (CRP', 'PCT', 'white blood cell count and CRP']","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0072027', 'cui_str': 'Procalcitonin'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",80.0,0.0145082,"Serum PCT is an early, sensitive and highly specific high-risk monitoring index and has an early prediction value for VAP after cardiac valve replacement.","[{'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Song', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Ji-Wei', 'Initials': 'JW', 'LastName': 'Gu', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yu-Jing', 'Initials': 'YJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}]",Scandinavian journal of clinical and laboratory investigation,['10.1080/00365513.2020.1762242']
2317,32425134,Comparison of dynamic arterial and venous pressure between metal needles and plastic cannulas in incident hemodialysis patients with arteriovenous graft.,"BACKGROUND AND OBJECTS


We hypothesized that plastic cannulae with 17-gauge inner needle compared to 16-gauge metal needles can have stable dynamic venous and arterial pressure maintaining prescribed blood flow safely during a hemodialysis treatment.
DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS


A single-center, prospective, randomized, open-label clinical trial was conducted involving 16 incident hemodialysis patients who had arteriovenous graft placed as their first arteriovenous access. Subjects were randomized to metal needle group (n = 8) versus plastic cannula group (n = 8). We measured serial dynamic pre-pump arterial and venous pressure under five different blood pump flow rates (150, 200, 250, 300, and 350 mL/min).
RESULTS


The mean age of patients was 67.6 ± 8.5 (range: 51-81) years, and six patients (37.5%) were male. Patients with plastic cannula showed less negative arterial pre-pump pressures and lower venous pressures than those with metal needles at all prescribed blood flow rates, and the difference was statistically significant (P < 0.001).
CONCLUSION


The plastic cannula had more stable arterial and venous pressures at prescribed blood pump flow rates than those pressures of the metal needle in incident patients with arteriovenous graft during hemodialysis.",2020,"Patients with plastic cannula showed less negative arterial pre-pump pressures and lower venous pressures than those with metal needles at all prescribed blood flow rates, and the difference was statistically significant (P < 0.001).
","['16 incident hemodialysis patients who had arteriovenous graft placed as their first arteriovenous access', 'incident hemodialysis patients with arteriovenous graft', 'The mean age of patients was 67.6\u2009±\u20098.5 (range: 51-81)\u2009years, and six patients (37.5%) were male']","['dynamic arterial and venous pressure between metal needles and plastic cannulas', 'metal needle group (n\u2009=\u20098) versus plastic cannula']","['negative arterial pre-pump pressures and lower venous pressures', 'blood flow rates', 'stable arterial and venous pressures']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729665', 'cui_str': 'Arteriovenous graft'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517742', 'cui_str': '37.5'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0042486', 'cui_str': 'Venous pressure'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042486', 'cui_str': 'Venous pressure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",16.0,0.0265089,"Patients with plastic cannula showed less negative arterial pre-pump pressures and lower venous pressures than those with metal needles at all prescribed blood flow rates, and the difference was statistically significant (P < 0.001).
","[{'ForeName': 'Sun Ryoung', 'Initials': 'SR', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Dongtan, Republic of Korea.'}, {'ForeName': 'Pyoungju', 'Initials': 'P', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Sohee', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Cheolsu', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Narae', 'Initials': 'N', 'LastName': 'Joo', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Jwa Kyung', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Young Rim', 'Initials': 'YR', 'LastName': 'Song', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Hyung Jik', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Sung Gyun', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Hyung Seok', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}]",The journal of vascular access,['10.1177/1129729820916579']
2318,32425813,A Novel Predictive Method Incorporating Parameters of Main Pulmonary Artery Bifurcation for Short-Term Prognosis in Non-high-risk Acute Pulmonary Embolism Patients.,"The aim of this study was to build a formula to predict short-term prognosis using main pulmonary artery (MPA) parameters reconstructed from computed tomographic pulmonary angiography in non-high-risk acute pulmonary embolism (PE) patients. After reconstructing the MPA and its centerline, the MPA, the right and left pulmonary artery inlet, and the MPA outlet plane were differentiated to measure the cross-sectional area (CSA), the maximal diameter and the hydraulic diameter. The MPA bifurcation area, volume and angle were measured. MPA dilation was defined as >29 mm at the transverse section plane. The patients were randomly divided into a training set and a validation set. A least absolute shrinkage and selection operator (LASSO) logistic regression algorithm was used to build a predictive formula. The performances of the predictive formula from LASSO were tested by the area under the receiver operating characteristic curve (AUC) and precision-recall (PR) curve with 10-fold cross-validation. The clinical utility was assessed by decision curve analysis (DCA). In total, 296 patients were enrolled and randomly divided (50:50) into a training set and a validation set. The LASSO predictive formula (lambda.1SE) was as follows: 0.92 × MPA bifurcation area + 0.50 × MPA outlet hydraulic diameter + 0.10 × MPA outlet CSA. The AUCs of the predictive formula were 0.860 (95% CI: 0.795-0.912) and 0.943 (95% CI: 0.892-0.975) in the training set and validation set, respectively. The LASSO predictive formula had a higher average area under the PR curve than MPA dilation (0.71 vs. 0.23 in the training set and 0.55 vs. 0.23 in the validation set) and added a net benefit in clinical utility by DCA. Integration of MPA outlet CSA, hydraulic diameter, and bifurcation area with the LASSO predictive formula as a novel weighting method facilitated the prediction of poor short-term prognosis within 30 days after hospital admission in non-high-risk acute PE patients.",2020,The AUCs of the predictive formula were 0.860,"['non-high-risk acute pulmonary embolism (PE) patients', 'Non-high-risk Acute Pulmonary Embolism Patients', '296 patients']",['main pulmonary artery (MPA) parameters reconstructed from computed tomographic pulmonary angiography'],"['MPA dilation', 'receiver operating characteristic curve (AUC) and precision-recall (PR) curve']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0677490', 'cui_str': 'Angiogram pulmonary'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0428851', 'cui_str': 'Dilatation of pulmonary artery'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",296.0,0.0213812,The AUCs of the predictive formula were 0.860,"[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Jia', 'Affiliation': 'Department of Emergency, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Xue-Lian', 'Initials': 'XL', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health, China Medical University, Shenyang, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Hou', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Zhou', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Shengjing Hospital of China Medical University, Shenyang, China.'}]",Frontiers in physiology,['10.3389/fphys.2020.00420']
2319,31128568,Null results of oxytocin and vasopressin administration across a range of social cognitive and behavioral paradigms: Evidence from a randomized controlled trial.,"Research examining oxytocin and vasopressin in humans has the potential to elucidate neurobiological mechanisms underlying human sociality that have been previously unknown or not well characterized. A primary goal of this work is to increase our knowledge about neurodevelopmental and psychiatric disorders characterized by impairments in social cognition. However, years of research highlighting wide-ranging effects of, in particular, intranasal oxytocin administration have been tempered as the fields of psychology, neuroscience, and other disciplines have been addressing concerns over the reproducibility and validity of research findings. We present a series of behavioral tasks that were conducted using a randomized, double-blind, placebo controlled, between-subjects design, in which our research group found no main effects of oxytocin and vasopressin on a host of social outcomes. In addition to null hypothesis significance testing, we implemented equivalence testing and Bayesian hypothesis testing to examine the sensitivity of our findings. These analyses indicated that 47-83% of our results (depending on the method of post-hoc analysis) had enough sensitivity to detect the absence of a main effect. Our results add to evidence that intranasal oxytocin may have a more limited direct effect on human social processes than initially assumed and suggest that the direct effects of intranasal vasopressin may be similarly limited. Randomized controlled trial registration: NCT01680718.",2019,Our results add to evidence that intranasal oxytocin may have a more limited direct effect on human social processes than initially assumed and suggest that the direct effects of intranasal vasopressin may be similarly limited.,[],"['intranasal oxytocin', 'placebo', 'oxytocin', 'oxytocin and vasopressin']",[],[],"[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}]",[],,0.210623,Our results add to evidence that intranasal oxytocin may have a more limited direct effect on human social processes than initially assumed and suggest that the direct effects of intranasal vasopressin may be similarly limited.,"[{'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Tabak', 'Affiliation': 'Department of Psychology, Southern Methodist University, Dallas, TX, United States. Electronic address: btabak@smu.edu.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Teed', 'Affiliation': 'Department of Psychology, Southern Methodist University, Dallas, TX, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Castle', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, United States.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Dutcher', 'Affiliation': 'Department of Psychology, Carnegie Mellon University, Pittsburgh, PA, United States.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Meyer', 'Affiliation': 'Department of Psychological and Brain Sciences, Dartmouth College, Hanover, NH, United States.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Bryan', 'Affiliation': 'Los Angeles Trade-Tech College, Los Angeles, CA, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, United States; Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles, CA, United States; Cousins Center for Psychoneuroimmunology, Jane and Terry Semel Institute for Neuroscience, David Geffen School of Medicine, University of California, Los Angeles, CA, United States.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Lieberman', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, United States; Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles, CA, United States.'}, {'ForeName': 'Naomi I', 'Initials': 'NI', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.04.019']
2320,32425857,Behavioral Intention Promotes Generalized Reciprocity: Evidence From the Dictator Game.,"Generalized reciprocity is the phenomenon that individuals treat others in the same way that others treated them in the past. Besides the behavioral outcomes, whether intention information also manipulates generalized reciprocal behavior remains unclear. By conducting two rounds of the dictator game, the current research investigated the influence from the dictator's intention on the receiver's following resource allocation performance. In the games, in order to allocate, either tokens in Experiment 1 or jobs in Experiment 2, a general tendency was shown to treat others better if one was generously treated than greedily treated. Regarding the intentionality, participants who received a generous offer (vs. greedy offer) from another person (i.e., intentional) would perform more generously to another person. However, if the offer was randomly given by a computer program (i.e., unintentional), the way in which one was being treated previously, became somewhat irrelevant to the participants' generalized reciprocal behaviors. Those findings verified the influence of the manipulation of intention on generalized reciprocity, and provided enlightenment for promoting friendly social interactions.",2020,"By conducting two rounds of the dictator game, the current research investigated the influence from the dictator's intention on the receiver's following resource allocation performance.",[],[],[],[],[],[],,0.0223232,"By conducting two rounds of the dictator game, the current research investigated the influence from the dictator's intention on the receiver's following resource allocation performance.","[{'ForeName': 'Zhongqiang', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Psychology, Ningbo University, Ningbo, China.'}, {'ForeName': 'Chuyuan', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': 'Department of Psychology, Ningbo University, Ningbo, China.'}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Department of Psychology, Ningbo University, Ningbo, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Business School, Ningbo University, Ningbo, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00772']
2321,32426038,Response to eculizumab in patients with myasthenia gravis recently treated with chronic IVIg: a subgroup analysis of REGAIN and its open-label extension study.,"Background


In the phase III eculizumab for refractory generalized myasthenia gravis REGAIN study [ClinicalTrials.gov identifier: NCT01997229] and its open-label extension (OLE) [ClinicalTrials.gov identifier: NCT02301624], patients with treatment-refractory antiacetylcholine receptor antibody-positive generalized myasthenia gravis had clinically meaningful improvements with eculizumab  versus  placebo. This subgroup analysis evaluated data from patients with a recent history of chronic intravenous immunoglobulin (IVIg) use before study entry.
Methods


The subgroup comprised patients who had received IVIg at least four times in 1 year, with at least one IVIg treatment cycle during the 6 months before the first REGAIN study dose. Data from REGAIN and the OLE were analyzed. Response to eculizumab  versus  placebo was assessed using four validated, disease-specific measures. Incidences of exacerbations and safety endpoints were recorded.
Results


The subgroup had similar patient and disease characteristics as the overall REGAIN population. Clinical assessments showed sustained eculizumab efficacy during REGAIN and the OLE over 18 months. Patients receiving placebo in REGAIN experienced rapid improvements in assessment scores when treated with eculizumab in the OLE. There was a lower rate of disease exacerbations with eculizumab than with placebo during REGAIN, and eculizumab was well tolerated.
Conclusion


Eculizumab treatment, compared with placebo, results in meaningful clinical improvements and fewer disease exacerbations for patients who previously received chronic IVIg.
Trial registration


REGAIN [ClinicalTrials.gov identifier: NCT01997229]; REGAIN open-label extension [ClinicalTrials.gov identifier: NCT02301624].",2020,Patients receiving placebo in REGAIN experienced rapid improvements in assessment scores when treated with eculizumab in the OLE.,"['patients who previously received chronic IVIg', 'patients with myasthenia gravis recently treated with chronic IVIg', 'patients with treatment-refractory antiacetylcholine receptor antibody-positive generalized myasthenia gravis', 'patients with a recent history of chronic intravenous immunoglobulin (IVIg) use before study entry']","['eculizumab', 'eculizumab  versus  placebo', 'placebo']","['tolerated', 'assessment scores', 'Incidences of exacerbations and safety endpoints', 'sustained eculizumab efficacy', 'disease exacerbations', 'rate of disease exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0877150', 'cui_str': 'Antiacetylcholine receptor antibody positive'}, {'cui': 'C0472367', 'cui_str': 'Generalized myasthenia'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0235874', 'cui_str': 'Condition aggravated'}]",,0.286744,Patients receiving placebo in REGAIN experienced rapid improvements in assessment scores when treated with eculizumab in the OLE.,"[{'ForeName': 'Saiju', 'Initials': 'S', 'LastName': 'Jacob', 'Affiliation': 'Queen Elizabeth Neuroscience Centre and Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Mindelsohn Way, Edgbaston, Birmingham, B15 2WB, UK.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Murai', 'Affiliation': 'Department of Neurology, International University of Health and Welfare, Narita, Japan.'}, {'ForeName': 'Kimiaki', 'Initials': 'K', 'LastName': 'Utsugisawa', 'Affiliation': 'Department of Neurology, Hanamaki General Hospital, Hanamaki, Japan.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Nowak', 'Affiliation': 'Department of Neurology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Wiendl', 'Affiliation': 'Department of Neurology, University of Münster, Münster, Germany.'}, {'ForeName': 'Kenji P', 'Initials': 'KP', 'LastName': 'Fujita', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': ""O'Brien"", 'Affiliation': 'Alexion Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Howard', 'Affiliation': 'Department of Neurology, University of North Carolina, Chapel Hill, NC, USA.'}]",Therapeutic advances in neurological disorders,['10.1177/1756286420911784']
2322,31543378,Administration of eicosapentaenoic acid may alter high-density lipoprotein heterogeneity in statin-treated patients with stable coronary artery disease: A 6-month randomized trial.,"BACKGROUND


Combined statin plus eicosapentaenoic acid (EPA) therapy might be a potentially effective treatment option to prevent coronary artery disease (CAD). The serum EPA/arachidonic acid (AA) ratio has been identified as a potential new risk marker for CAD. Few data exist whether administration of EPA could affect high-density lipoprotein (HDL) particle size. We hypothesized that the addition of EPA to ongoing statin therapy may result in altered HDL heterogeneity.
METHODS


We conducted this 6-month, single-center, prospective, randomized open-label clinical trial to investigate the effect of the additional administration of EPA on the HDL heterogeneity (HDL 2 , HDL 3,  and HDL 2 /HDL 3  ratio) in stable CAD patients receiving treatment with statins. We assigned stable CAD patients already receiving statin therapy to the EPA group (1800mg/day: n=50) or the control group (n=50).
RESULTS


A significant decrease in the serum HDL 3  level (-4.7% vs. -0.5%, p=0.037), but not of the serum HDL 2  level, and a significant increase in the HDL 2 /HDL 3  ratio (5.5% vs. -5.1%, p=0.032) were observed in the EPA group as compared to the control group. Multiple regression analysis with adjustments for coronary risk factors identified the achieved EPA/ AA ratio as an independent and significant predictor of an increase of the HDL 2 /HDL 3  ratio (β=0.295, p=0.001). Furthermore, the change in the serum cholesterol ester transfer protein mass was positively correlated with the change in the EPA/AA ratio in the EPA group (r=0.286, p=0.044), but not in the control group (r=0.121, p=0.401).
CONCLUSION


Administration of EPA might decrease the serum HDL 3  level, resulting in an increase in the HDL 2 /HDL 3  ratio. Furthermore, increased EPA/AA ratio by the addition of EPA to ongoing statin therapy might be an indicator of an increase in the HDL 2 /HDL 3  ratio, thereby regulating HDL particle size.
CLINICAL TRIAL REGISTRATION


UMIN (http://www.umin.ac.jp/) Study ID: UMIN000010452.",2020,"A significant decrease in the serum HDL 3  level (-4.7% vs. -0.5%, p=0.037), but not of the serum HDL 2  level, and a significant increase in the HDL 2 /HDL 3  ratio (5.5% vs. -5.1%, p=0.032) were observed in the EPA group as compared to the control group.","['statin-treated patients with stable coronary artery disease', 'n=50) or the control group (n=50', 'stable CAD patients receiving treatment with statins']","['statin plus eicosapentaenoic acid (EPA) therapy', 'eicosapentaenoic acid', 'EPA']","['density lipoprotein (HDL) particle size', 'serum HDL 3  level', 'EPA/AA ratio', 'EPA/ AA ratio', 'serum EPA/arachidonic acid (AA) ratio', 'serum cholesterol ester transfer protein mass']","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}]","[{'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023814', 'cui_str': 'HDL-3'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol'}, {'cui': 'C0014898', 'cui_str': 'Esters'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.0711713,"A significant decrease in the serum HDL 3  level (-4.7% vs. -0.5%, p=0.037), but not of the serum HDL 2  level, and a significant increase in the HDL 2 /HDL 3  ratio (5.5% vs. -5.1%, p=0.032) were observed in the EPA group as compared to the control group.","[{'ForeName': 'Shigemasa', 'Initials': 'S', 'LastName': 'Tani', 'Affiliation': 'Department of Health Planning Center and Cardiology, Nihon University Hospital, Tokyo Japan. Electronic address: tani.shigemasa@nihon-u.ac.jp.'}, {'ForeName': 'Rei', 'Initials': 'R', 'LastName': 'Matsuo', 'Affiliation': 'Department of Cardiology, Nihon University Hospital, Tokyo Japan.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Yagi', 'Affiliation': 'Department of Cardiology, Nihon University Hospital, Tokyo Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Nihon University Hospital, Tokyo Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.08.011']
2323,32424986,Efficacy of a collagen hydrolysate and antioxidants-containing nutraceutical on metrics of skin health in Indian women.,"BACKGROUND


The skin's aging process involves a decreased biosynthesis of extracellular matrix proteins (predominantly collagen) compounded by damage from environmental and intrinsic stressors. The Indian population is susceptible to skin damage given its geography and increasing urbanization or a genetic disposition. Previous studies have investigated nutrients such as collagen peptides, vitamins and phytonutrient-rich botanical extracts for their individual benefits on skin.
AIMS


This study examined the collective effect of a proprietary blend of these nutrients (in Nutrova Collagen+Antioxidants; NCA) on skin parameters, which has not been previously studied, especially in an Indian context.
PATIENTS/METHODS


34 healthy, Indian women (mean age = 39.5 years) were given a placebo daily for 30 days to establish a baseline, followed by NCA for two intervals of 30 days. 3D image reconstruction allowed the analysis of skin topography and blemishes. Instrumental measurements also included skin firmness, elasticity, hydration, and transepidermal water loss. Clinical evaluation was used to grade blemishes, wrinkles and periorbital hyperpigmentation.
RESULTS


Based on instrumental evaluation, NCA significantly reduced wrinkle width, open pores, skin roughness, and the colour of hyperpigmented blemishes, while improving skin hydration, firmness and barrier function from baseline to Day 30 and Day 60. NCA also increased elasticity at Day 30. Clinical evaluation showed that periorbital hyperpigmentation and wrinkles reduced significantly.
CONCLUSION


NCA is effective for improving overall skin health in Indian women. These results show that targeted nutrient supplementation can improve skin health and further research over extended durations is merited.",2020,"Based on instrumental evaluation, NCA significantly reduced wrinkle width, open pores, skin roughness, and the colour of hyperpigmented blemishes, while improving skin hydration, firmness and barrier function from baseline to Day 30 and Day 60.","['34 healthy, Indian women (mean age = 39.5 years', 'Indian women']","['NCA', 'collagen hydrolysate and antioxidants-containing nutraceutical', 'proprietary blend of these nutrients (in Nutrova Collagen+Antioxidants; NCA', 'placebo']","['periorbital hyperpigmentation and wrinkles reduced significantly', 'skin health', 'overall skin health', 'skin firmness, elasticity, hydration, and transepidermal water loss', 'wrinkle width, open pores, skin roughness, and the colour of hyperpigmented blemishes, while improving skin hydration, firmness and barrier function']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0230064', 'cui_str': 'Periorbital'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",34.0,0.0230159,"Based on instrumental evaluation, NCA significantly reduced wrinkle width, open pores, skin roughness, and the colour of hyperpigmented blemishes, while improving skin hydration, firmness and barrier function from baseline to Day 30 and Day 60.","[{'ForeName': 'Meghna S', 'Initials': 'MS', 'LastName': 'Motwani', 'Affiliation': 'Axys Nutrition Products Pvt. Ltd., Mumbai, India.'}, {'ForeName': 'Kaynat', 'Initials': 'K', 'LastName': 'Khan', 'Affiliation': 'Axys Nutrition Products Pvt. Ltd., Mumbai, India.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Pai', 'Affiliation': 'Axys Nutrition Products Pvt. Ltd., Mumbai, India.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Joshi', 'Affiliation': 'CLAIMS Pvt. Ltd., Mumbai, India.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13404']
2324,32426316,Group Nutrition Counseling or Individualized Prescription for Women With Obesity? A Clinical Trial.,"Background:  This study investigates the effects of group counseling vs. individual dietary prescription on physical, nutritional, and mental health in overweight or obese women.  Methods:  Seventy-four women aged 40-59 years with body mass index ≥ 25 kg/m 2  were randomized into 2 intervention arms: group nutrition counseling (GNC) or individualized nutrition prescription (INP). Twenty-seven women completed the 12-week intervention protocol. The GNC received counseling once a week and the INP received an individualized prescription once a month. All participants attended physical exercise sessions 3 times a week following the same protocol. Body mass, body mass index, fat mass, body fat percentage, lean mass, lipid profile, hemoglobin A1c, insulin and liver transaminases were measured pre- and post-intervention in both arms. A 3 day food record was applied to calculate the intake of calories, carbohydrates, proteins, and lipids. Body image dissatisfaction, level of anxiety, self-esteem measure and pathological eating attitudes were measured.  Results:  Both dietary interventions decreased body mass, body mass index, fat mass, body fat percentage, total caloric intake, carbohydrates, proteins, lipids, body dissatisfaction, anxiety, and saturated and polyunsaturated fats ( p  < 0.05). Lean mass, metabolic variables, self-esteem and pathological eating attitudes remained unchanged ( p  > 0.05).  Conclusion:  Both nutritional interventions combined with concurrent exercise were effective to improve anthropometrics, body composition, food intake, and some mental health parameters. We suggest that the choice of nutritional intervention (GNC or INP) could be based on the participants preference, considering the adherence and satisfaction, to promote health and quality of life.",2020,"Lean mass, metabolic variables, self-esteem and pathological eating attitudes remained unchanged ( p  > 0.05).  ","['Twenty-seven women completed the 12-week intervention protocol', 'overweight or obese women', 'Methods:  Seventy-four women aged 40-59 years with body mass index ≥ 25 kg/m 2']","['group counseling vs. individual dietary prescription', 'nutritional intervention (GNC or INP', 'nutritional interventions combined with concurrent exercise', 'group nutrition counseling (GNC) or individualized nutrition prescription (INP', 'Group Nutrition Counseling or Individualized Prescription']","['body mass, body mass index, fat mass, body fat percentage, total caloric intake, carbohydrates, proteins, lipids, body dissatisfaction, anxiety, and saturated and polyunsaturated fats', 'Lean mass, metabolic variables, self-esteem and pathological eating attitudes', 'anthropometrics, body composition, food intake, and some mental health parameters', 'Body image dissatisfaction, level of anxiety, self-esteem measure and pathological eating attitudes', 'Body mass, body mass index, fat mass, body fat percentage, lean mass, lipid profile, hemoglobin A1c, insulin and liver transaminases']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0237547', 'cui_str': 'Group counseling'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}]",74.0,0.0469469,"Lean mass, metabolic variables, self-esteem and pathological eating attitudes remained unchanged ( p  > 0.05).  ","[{'ForeName': 'Marciele Alves', 'Initials': 'MA', 'LastName': 'Bolognese', 'Affiliation': 'Post-Graduation Program in Health Promotion, University Center of Maringa, Maringa, Brazil.'}, {'ForeName': 'Carina Bertoldi', 'Initials': 'CB', 'LastName': 'Franco', 'Affiliation': 'Medicine Department, University Center of Maringa, Maringa, Brazil.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Ferrari', 'Affiliation': 'Post-Graduation Program in Science, Technology and Food Safety, University Center of Maringa, Maringa, Brazil.'}, {'ForeName': 'Rose Mari', 'Initials': 'RM', 'LastName': 'Bennemann', 'Affiliation': 'Post-Graduation Program in Health Promotion, University Center of Maringa, Maringa, Brazil.'}, {'ForeName': 'Solange Munhoz Arroyo', 'Initials': 'SMA', 'LastName': 'Lopes', 'Affiliation': 'Medicine Department, University Center of Maringa, Maringa, Brazil.'}, {'ForeName': 'Sônia Maria Marques Gomes', 'Initials': 'SMMG', 'LastName': 'Bertolini', 'Affiliation': 'Post-Graduation Program in Health Promotion, University Center of Maringa, Maringa, Brazil.'}, {'ForeName': 'Nelson Nardo', 'Initials': 'NN', 'LastName': 'Júnior', 'Affiliation': 'Department of Physical Education, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Braulio Henrique Magnani', 'Initials': 'BHM', 'LastName': 'Branco', 'Affiliation': 'Post-Graduation Program in Health Promotion, University Center of Maringa, Maringa, Brazil.'}]",Frontiers in public health,['10.3389/fpubh.2020.00127']
2325,25372556,Effects of vitamin E from supplements and diet on colonic α- and γ-tocopherol concentrations in persons at increased colon cancer risk.,"The available evidence indicates that γ-tocopherol has more potential for colon cancer prevention than α-tocopherol, but little is known about the effects of foods and supplements on tocopherol levels in human colon. This study randomized 120 subjects at increased colon cancer risk to either a Mediterranean or a Healthy Eating diet for 6 mo. Supplement use was reported by 39% of the subjects, and vitamin E intake from supplements was twofold higher than that from foods. Serum α-tocopherol at baseline was positively predicted by dietary intakes of synthetic vitamin E in foods and supplements but not by natural α-tocopherol from foods. For serum γ-tocopherol, dietary γ-tocopherol was not a predictor, but dietary α-tocopherol was a negative predictor. Unlike with serum, the data supported a role for metabolic factors, and not a direct effect of diet, in governing concentrations of both α- and γ-tocopherol in colon. The Mediterranean intervention increased intakes of natural α-tocopherol, which is high in nuts, and decreased intakes of γ-tocopherol, which is low in olive oil. These dietary changes had no significant effects on colon tocopherols. The impact of diet on colon tocopherols therefore appears to be limited.",2015,Serum α-tocopherol at baseline was positively predicted by dietary intakes of synthetic vitamin E in foods and supplements but not by natural α-tocopherol from foods.,"['human colon', 'persons at increased colon cancer risk', '120 subjects at increased colon cancer risk to either a Mediterranean or a Healthy Eating diet for 6 mo']","['vitamin E', 'γ-tocopherol']","['colonic α', 'Serum α-tocopherol', 'tocopherol levels', 'intakes of natural α-tocopherol', 'colon tocopherols']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}]","[{'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}]",120.0,0.0186771,Serum α-tocopherol at baseline was positively predicted by dietary intakes of synthetic vitamin E in foods and supplements but not by natural α-tocopherol from foods.,"[{'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'a Department of Family Medicine , University of Michigan , Ann Arbor , Michigan , USA.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': ''}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Askew', 'Affiliation': ''}, {'ForeName': 'Elkhansa', 'Initials': 'E', 'LastName': 'Sidahmed', 'Affiliation': ''}, {'ForeName': 'Dean E', 'Initials': 'DE', 'LastName': 'Brenner', 'Affiliation': ''}, {'ForeName': 'Mack T', 'Initials': 'MT', 'LastName': 'Ruffin', 'Affiliation': ''}, {'ForeName': 'D Kim', 'Initials': 'DK', 'LastName': 'Turgeon', 'Affiliation': ''}, {'ForeName': 'Zora', 'Initials': 'Z', 'LastName': 'Djuric', 'Affiliation': ''}]",Nutrition and cancer,['10.1080/01635581.2015.965333']
2326,32425834,Metabolic Syndrome and Cognitive Functions in Schizophrenia-Implementation of Dietary Intervention.,"Introduction


The co-existence of schizophrenia and metabolic syndrome is a widely described phenomenon that contributes to the worse functioning of patients in everyday life. A relatively new area of research is the relationship between metabolic syndrome (MS) and cognitive function in patients with schizophrenia. The aim of the study was to verify the relationship between the presence of metabolic syndrome and cognitive function of patients with schizophrenia and to assess the possibility of changing cognitive function by introducing appropriate dietary intervention.
Materials and Methods


The study involved 87 individuals diagnosed with schizophrenia according to ICD-10 criteria, aged 19 to 67 years (M = 41.67; SD = 11.87). Patients were in the remission phase of schizophrenia, all using antipsychotics for pharmacological treatment. From a group of 83 patients with schizophrenia and diagnosed metabolic syndrome (according to IDF criteria) 30 patients were randomly assigned to an experimental group-with dietary intervention, 29 patients-to group without dietary intervention, 24 patients with schizophrenia without metabolic syndrome was a comparison group. All groups were evaluated for cognitive function using Stroop Test, Trail Making Test (TMT), Verbal Fluency Test, Digit Span Backwards Test. In the experimental group a dietary intervention was applied, which was to provide the examined person with a 7-day dietary plan with reduced calorie content, in compliance with the Mediterranean diet.
Results


After the dietary intervention there was a significant improvement in the number of errors made in the third Stroop Test (p <0.001), the time taken to complete the Point Linking Test was shortened (Test B; p = 0.005), there was an improvement in Verbal Fluency Test in ""animals"" category (p = 0.006) ""sharp objects"" category (p = 0.009), the number of repeated digits has increased in Digit Span Test in ""forward"" category (p = 0.001) and overall completion of the test (p = 0.021). In the group of patients with MS without dietary intervention, the results of cognitive tests remained mostly unchanged.
Conclusions


Change of eating habits may be a significant element of a holistic approach to the problems of treatment of schizophrenia.",2020,"Test B; p = 0.005), there was an improvement in Verbal Fluency Test in ""animals"" category (p = 0.006) ""sharp objects"" category (p = 0.009), the number of repeated digits has increased in Digit Span Test in ""forward"" category (p = 0.001) and overall completion of the test (p = 0.021).","['patients with schizophrenia', '87 individuals diagnosed with schizophrenia according to ICD-10 criteria, aged 19 to 67 years (M = 41.67; SD = 11.87', '24 patients with schizophrenia without metabolic syndrome was a comparison group', '83 patients with schizophrenia and diagnosed metabolic syndrome (according to IDF criteria) 30 patients']","['experimental group-with dietary intervention, 29 patients-to group without dietary intervention']","['Digit Span Test', 'cognitive function using Stroop Test, Trail Making Test (TMT), Verbal Fluency Test, Digit Span Backwards Test', 'number of errors made', 'Verbal Fluency Test', 'time taken to complete the Point Linking Test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0063545', 'cui_str': 'inhibitory diffusible factor 45'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",87.0,0.0152469,"Test B; p = 0.005), there was an improvement in Verbal Fluency Test in ""animals"" category (p = 0.006) ""sharp objects"" category (p = 0.009), the number of repeated digits has increased in Digit Span Test in ""forward"" category (p = 0.001) and overall completion of the test (p = 0.021).","[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Adamowicz', 'Affiliation': 'Department and Clinic of Psychiatry, Pomeranian Medical University, Szczecin, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Mazur', 'Affiliation': 'Department of Social Sciences, Institute of Psychology, University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Mak', 'Affiliation': 'Department and Clinic of Psychiatry, Pomeranian Medical University, Szczecin, Poland.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Samochowiec', 'Affiliation': 'Department and Clinic of Psychiatry, Pomeranian Medical University, Szczecin, Poland.'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Kucharska-Mazur', 'Affiliation': 'Department and Clinic of Psychiatry, Pomeranian Medical University, Szczecin, Poland.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00359']
2327,32426197,Combined Nimotuzumab with Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma.,"Background Most head and neck cancers (HNCs), specifically squamous cell carcinoma, express epidermal growth factor and are associated with an inadequate response to radiotherapy and chemotherapy. Anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAb) increase response rates and survival when combined with radiotherapy or chemoradiotherapy (CRT). This study evaluates the outcome and toxicity of the nimotuzumab-CRT combination for stage III, IVa, and IVb squamous cell carcinoma of the head and neck. Methods Eighty-seven patients with squamous cell carcinoma of the head and neck, stage III, IVa, or IVb were enrolled in a prospective comparative study. The nimotuzumab plus CRT group consisted of patients who received nimotuzumab 200 mg every week for six consecutive weeks chemoradiation therapy; cisplatin 30 mg/m 2  every week for six weeks; radiotherapy of 2-Gy/fraction, five fractions/week for a total dose of 70 Gy; and neck lymph node invasion prophylaxis at 50 Gy. The CRT alone arm was treated with CRT (without nimotuzumab). Results Tumor response rate of 90.6% was achieved in nimotuzumab plus CRT group (complete response: 58.1%), and 70.4% in CRT alone arm (complete response: 38.6%; p=0.029). The lymph node response rate was 83.4% in nimotuzumab plus CRT group (complete response: 46.7%), and 73.0% in CRT group (complete response: 23.0%). The general response rate in nimotuzumab plus CRT group was 86.0% (complete response: 48.8%), and 68.0% in CRT alone arm (complete response: 36.0%). Twelve-month overall survival (OS) was 75.1% for the nimotuzumab plus CRT group and 54.4% for the CRT group. The 24-month survival was 48.0% (nimotuzumab plus CRT group) and 29.0% (CRT alone arm). The median OS was 20 months and 13 months for nimotuzumab plus CRT group and CRT alone arm, respectively. Progression-free survival (PFS) in the nimotuzumab plus CRT group at 12 months and 24 months was 64.2% and 37.4%, respectively. PFS in the CRT group at 12 months and 24 months was 39.5% and 21.3%, respectively. Infusion reaction presented mildly in two of 43 patients in the nimotuzumab plus CRT group, and no shock occurred. Other toxicity occurrences were similar between the two groups, mainly in grade I, II. Skin rash (grade I only) occurred at a rate of 4.7% in the nimotuzumab plus CRT group. Conclusion Nimotuzumab in combination with CRT was well tolerated as a treatment program for locally advanced head and neck squamous cell carcinoma.",2020,Twelve-month overall survival (OS) was 75.1% for the nimotuzumab plus CRT group and 54.4% for the CRT group.,"['stage III, IVa, and IVb squamous cell carcinoma of the head and neck', 'locally advanced head and neck squamous cell carcinoma', 'Locally Advanced Head and Neck Squamous Cell Carcinoma', 'Methods Eighty-seven patients with squamous cell carcinoma of the head and neck, stage III, IVa, or IVb']","['radiotherapy or chemoradiotherapy (CRT', 'CRT', 'CRT (without nimotuzumab', 'Combined Nimotuzumab with Chemoradiotherapy', 'nimotuzumab plus CRT', 'nimotuzumab', 'nimotuzumab-CRT combination', 'chemoradiation therapy; cisplatin']","['Progression-free survival (PFS', 'PFS', 'median OS', 'lymph node response rate', 'Tumor response rate', 'overall survival (OS', 'Skin rash', 'general response rate', '24-month survival', 'toxicity occurrences']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1570308', 'cui_str': 'Nimotuzumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",87.0,0.0447932,Twelve-month overall survival (OS) was 75.1% for the nimotuzumab plus CRT group and 54.4% for the CRT group.,"[{'ForeName': 'Nguyen Thi', 'Initials': 'NT', 'LastName': 'Thai Hoa', 'Affiliation': 'Department of Internal Medicine, Vietnam National Cancer Hospital, Hanoi, VNM.'}, {'ForeName': 'Huynh', 'Initials': 'H', 'LastName': 'Quang Huy', 'Affiliation': 'Radiology, Pham Ngoc Thach University of Medicine, Ho Chi Minh City, VNM.'}]",Cureus,['10.7759/cureus.8105']
2328,32425872,Effect of Remote Ischemic Conditioning in Patients With Takotsubo Syndrome After Acute Stroke: Study Protocol for a Randomized Controlled Trial.,"Introduction:  Takotsubo syndrome (TTS) is an acute heart failure syndrome which is preceded by a variety of emotional or physical triggers, with central nervous system conditions being an important trigger. Remote ischemic conditioning (RIC) is a promising interventional treatment based on the probability that both TTS and acute coronary syndrome may respond similarly to interventions. The heart protection effect of RIC has been repeatedly confirmed in animal models and observational clinical trials; however, it has never been studied in patients with TTS after acute stroke in randomized clinical trials with a higher level of evidence. The present study will be a proof-of-concept study to determine whether RIC can reduce cardiac injury and eventually improve the heart function and clinical outcomes of TTS patients after acute stroke.  Methods and Analysis:  A single-center, outcome-assessor-blinded, randomized controlled trial (RCT) will be conducted to evaluate the effect of RIC in TTS patients after acute stroke. Major eligibility criteria include TTS patients diagnosed with acute stroke, which can be confirmed on computed tomography or magnetic resonance imaging; patients aged 18-75 years; patients admitted to a hospital within 48 h after the onset of acute stroke; and patients diagnosed with Takotsubo cardiomyopathy with an InterTAK diagnostic score ≥50. A total of 60 eligible patients will be randomly allocated into either the RIC or the control group. The primary endpoint is a composite of death from any cause and major adverse cardiac and cerebrovascular events during the in-hospital period and at the 1- and 6-month follow-up.  Ethics and dissemination:  This study has been approved by the Medical Ethics Committee of Xuanwu Hospital, Capital Medical University ([2017] 072). The study findings will be presented at international conferences and published in a peer-reviewed journal.  Trial registration:  This study has been prospectively registered in the Chinese Clinical Trial Registry on September 10, 2018 (ChiCTR1800018290).",2020,Remote ischemic conditioning (RIC) is a promising interventional treatment based on the probability that both TTS and acute coronary syndrome may respond similarly to interventions.,"['TTS patients after acute stroke', '60 eligible patients', 'Patients With Takotsubo Syndrome', 'Major eligibility criteria include TTS patients diagnosed with acute stroke, which can be confirmed on computed tomography or magnetic resonance imaging; patients aged 18-75 years; patients admitted to a hospital within 48 h after the onset of acute stroke; and patients diagnosed with Takotsubo cardiomyopathy with an InterTAK diagnostic score ≥50']","['Introduction:  Takotsubo syndrome (TTS', 'Remote Ischemic Conditioning', 'Remote ischemic conditioning (RIC']",['composite of death from any cause and major adverse cardiac and cerebrovascular events during the in-hospital period and at the 1- and 6-month follow-up'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C1739395', 'cui_str': 'Takotsubo cardiomyopathy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1739395', 'cui_str': 'Takotsubo cardiomyopathy'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",60.0,0.273839,Remote ischemic conditioning (RIC) is a promising interventional treatment based on the probability that both TTS and acute coronary syndrome may respond similarly to interventions.,"[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yueqiao', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Weitao', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}]",Frontiers in neurology,['10.3389/fneur.2020.00286']
2329,32425873,"Follow-Up in Aphasia Caused by Acute Stroke in a Prospective, Randomized, Clinical, and Experimental Controlled Noninvasive Study With an iPad-Based App (Neolexon®): Study Protocol of the Lexi Study.","Rationale:  Treatment of aphasia is still challenging for clinicians and patients. So far, there is proven evidence for ""face-to-face"" speech therapy. However, the digital age potentially offers new and complementary strategies that may add to treatment outcome in a cost-effective way. Neolexon® is a commercial tablet-based software for treatment of aphasia, which can be applied with the help of a therapist or as self-training by the patient.  Aims and hypothesis:  In the Lexi study, we aim to determine whether treatment with Neolexon® is superior to standard therapy in acute post-stroke aphasia.  Sample size estimates:  A sample size of 180 patients, 90 for each group, will be included with an assumed dropout rate of ~20%.  Methods and design:  Prospective, randomized, parallel group, open-label, blinded-endpoint clinical, and experimental controlled non-invasive trial (PROBE). Adult German native speakers with acute aphasia after stroke are included. Computer-generated, blocked, and stratified randomization by aphasia severity will assign patients to one of two groups: 4 weeks of either standard logopedic speech therapy or logopedic speech therapy with the app version of Neolexon®. Both groups will be instructed in self-training: the frequency and duration of self-training will be documented. Screening for aphasia will be performed using the Language Screening Test (LAST). The severity of aphasia in general and in subitems will be assessed using the Bielefelder Aphasie Screening (BIAS) and the Aphasia Check List (ACL). Follow-up will be assessed after 3 months.  Study outcomes:  Based on the consensus in our study team, we considered a 10% mean difference in the change of percentile rank (PR) of BIAS to be a minimal and clinically important difference. The primary endpoint is defined as a significant difference in BIAS comparing the two groups. Differences in quality of life, Beck Depression Inventory (BDI), and modified Ranking Scale (mRS) will be evaluated as secondary outcome parameters.  Discussion:  This trial will determine whether speech therapy with the use of Neolexon® is superior to standard logopedic therapy. Subgroups with the greatest response to Neolexon® will be described. The trial was prospectively registered on the ""EU Clinical Trials Register"" (NCT04080817).",2020,This trial will determine whether speech therapy with the use of Neolexon® is superior to standard logopedic therapy.,"['180 patients, 90 for each group, will be included with an assumed dropout rate of ~20', 'Adult German native speakers with acute aphasia after stroke']","['Neolexon®', 'standard logopedic speech therapy or logopedic speech therapy with the app version of Neolexon®']","['quality of life, Beck Depression Inventory (BDI), and modified Ranking Scale (mRS']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009460', 'cui_str': 'Communication disorder'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0699794', 'cui_str': 'Rank'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]",180.0,0.0879635,This trial will determine whether speech therapy with the use of Neolexon® is superior to standard logopedic therapy.,"[{'ForeName': 'Dennis C', 'Initials': 'DC', 'LastName': 'Thunstedt', 'Affiliation': 'Department of Neurology, Ludwig Maximilians University (LMU), Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Department of Neurology, Medical Park Bad Feilnbach, Reithofpark, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Küpper', 'Affiliation': 'Department of Neurology, Ludwig Maximilians University (LMU), Munich, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Müller', 'Affiliation': 'Department of Neurology, Ludwig Maximilians University (LMU), Munich, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Becker', 'Affiliation': 'Department of Neurology, Ludwig Maximilians University (LMU), Munich, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Erbert', 'Affiliation': 'Department of Neurology, Ludwig Maximilians University (LMU), Munich, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Lehner', 'Affiliation': 'Department of Neurology, Ludwig Maximilians University (LMU), Munich, Germany.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Rheinwald', 'Affiliation': 'Department of Neurology, Ludwig Maximilians University (LMU), Munich, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Pfahler', 'Affiliation': 'Department of Neurology, Medical Park Bad Feilnbach, Reithofpark, Germany.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Dieterich', 'Affiliation': 'Department of Neurology, Ludwig Maximilians University (LMU), Munich, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kellert', 'Affiliation': 'Department of Neurology, Ludwig Maximilians University (LMU), Munich, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Feil', 'Affiliation': 'Department of Neurology, Ludwig Maximilians University (LMU), Munich, Germany.'}]",Frontiers in neurology,['10.3389/fneur.2020.00294']
2330,32426007,The Effectiveness of Attention Bias Modification with and without Trans Cranial Direct Current Stimulation in Chronic Low Back Pain.,"Objective:  The present study aimed to compare the effect of ABM (attention bias modification) with and without tDCS (transcranial direct current stimulation) on attention bias, pain intensity, and disability due to pain and pain-related psychological consequences, such as depression, anxiety, and stress.  Method   :  Using convenience sampling, 60 individuals who met the criteria for chronic low back pain (LBP) were selected and randomly assigned in to 2 experimental groups and 2 control and sham-tDCS groups. The experimental ABM group received 5 sessions of the dot-probe task, while the second experimental group received 5 sessions of dot-probe task combined with tDCS.  Results:  The findings indicated that ABM and ABM+tDCS could reduce attention bias and pain-related psychological consequences significantly, compared to the control and sham groups. Also, attention bias and pain outcomes (depression, anxiety, disability due to pain and pain intensity) remained in ABM+tDCS group than in ABM group in a 1-month follow-up.  Conclusion:  It was found that tDCS + ABM had no additional effects at the end of intervention, but led to more long-lasting effects in 1-month follow-up. Randomized clinical trial registry number: IRCT20171107037306N1.",2020,"It was found that tDCS + ABM had no additional effects at the end of intervention, but led to more long-lasting effects in 1-month follow-up.","['60 individuals who met the criteria for chronic low back pain (LBP', 'Chronic Low Back Pain']","['Attention Bias Modification with and without Trans Cranial Direct Current Stimulation', 'tDCS + ABM', '5 sessions of dot-probe task combined with tDCS', 'ABM (attention bias modification) with and without tDCS (transcranial direct current stimulation', 'control and sham-tDCS', 'ABM and ABM+tDCS']","['attention bias, pain intensity, and disability due to pain and pain-related psychological consequences, such as depression, anxiety, and stress', 'attention bias and pain outcomes (depression, anxiety, disability due to pain and pain intensity', 'attention bias and pain-related psychological consequences']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.0592629,"It was found that tDCS + ABM had no additional effects at the end of intervention, but led to more long-lasting effects in 1-month follow-up.","[{'ForeName': 'Yasaman', 'Initials': 'Y', 'LastName': 'Shiasy', 'Affiliation': 'Department of Clinical Psychology,\xa0University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Shakiba', 'Affiliation': 'Department of Clinical Psychology,\xa0University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Taremian', 'Affiliation': 'Substance Abuse and Dependence Research Center,\xa0University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Majid', 'Initials': 'SM', 'LastName': 'Akhavan Hejazi', 'Affiliation': 'Physical Medicine & Rehabilitation Specialist, Rofeideh Hospital, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Abasi', 'Affiliation': 'Department of Clinical Psychology,\xa0University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}]",Iranian journal of psychiatry,[]
2331,32426159,The feasibility and acceptability of an early intervention in primary care to prevent chronic fatigue syndrome (CFS) in adults: randomised controlled trial.,"Background


Chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis (ME)) is defined as fatigue that is disabling, is accompanied by additional symptoms and persists for ≥ 4 months. Treatment of CFS/ME aims to help patients manage their symptoms and make lifestyle adjustments. We do not know whether intervening early in primary care (< 4 months after onset of fatigue) can prevent the development of CFS/ME.
Methods


This was a feasibility randomised controlled trial with adults (age ≥ 18 years) comparing usual care with usual care plus an early intervention (EI; a combination of psycho-education and cognitive behavioural therapy, CBT). This study took place in fourteen primary care practices in Bristol, England and aimed to identify issues around recruitment and retention for a full-scale trial. It was not powered to support statistical analysis of differences in outcomes. Integrated qualitative methodology was used to explore the feasibility and acceptability of recruitment and randomisation to the intervention.
Results


Forty-four patients were recruited (1 August 2012-November 28, 2013), falling short of our predicted recruitment rate of 100 patients in 8 months. Qualitative data from GPs showed recruitment was not feasible because it was difficult to identify potential participants within 4 months of symptom onset. Some referring GPs felt screening investigations recommended by NICE were unnecessary, and they had difficulty finding patients who met the eligibility criteria. Qualitative data from some participant interviews suggested that the intervention was not acceptable in its current format. Although the majority of participants found parts of the intervention acceptable, many reported one or more problems with acceptability. Participants who discontinued the intervention or found it problematic did not relate to the therapeutic model, disliked telephone consultations or found self-reflection challenging.
Conclusions


A randomised controlled trial to test an early intervention for fatigue in adults in primary care is not feasible using this intervention and recruitment strategy.
Trial registration


International Standard Randomised Controlled Trials, ISRCTN72645894. Retrospectively registered on 17 May 2013.",2020,"Conclusions


A randomised controlled trial to test an early intervention for fatigue in adults in primary care is not feasible using this intervention and recruitment strategy.
","['Participants who discontinued the intervention or found it problematic did not relate to the therapeutic model, disliked telephone consultations or found self-reflection challenging', 'fourteen primary care practices in Bristol, England and aimed to identify issues around recruitment and retention for a full-scale trial', 'adults (age ≥\u200918\u2009years) comparing', 'Forty-four patients were recruited (1 August 2012-November 28, 2013), falling short of our predicted recruitment rate of 100 patients in 8\u2009months', 'primary care to prevent chronic fatigue syndrome (CFS) in adults']","['usual care with usual care plus an early intervention (EI; a combination of psycho-education and cognitive behavioural therapy, CBT', 'early intervention', 'CFS/ME']",[],"[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0175745', 'cui_str': 'Telephone consultation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}]",[],44.0,0.188352,"Conclusions


A randomised controlled trial to test an early intervention for fatigue in adults in primary care is not feasible using this intervention and recruitment strategy.
","[{'ForeName': 'Hazel', 'Initials': 'H', 'LastName': ""O'Dowd"", 'Affiliation': '1CFS/NHS Bristol, The Lodge, Cossham Hospital, Lodge Road, Kingswood, Bristol, BS15 1LF UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Beasant', 'Affiliation': '2Bristol Medical School, University of Bristol, Bristol, BS8 1NU UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ingram', 'Affiliation': '2Bristol Medical School, University of Bristol, Bristol, BS8 1NU UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Montgomery', 'Affiliation': '3School of Medicine, University of Nottingham, Nottingham, NG7 2UH UK.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': '2Bristol Medical School, University of Bristol, Bristol, BS8 1NU UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Gaunt', 'Affiliation': '4Bristol Randomised Trials Collaboration, Bristol Medical School, University of Bristol, Bristol, BS8 2PS UK.'}, {'ForeName': 'Simon M', 'Initials': 'SM', 'LastName': 'Collin', 'Affiliation': '2Bristol Medical School, University of Bristol, Bristol, BS8 1NU UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Horne', 'Affiliation': '5CFS/NHS Bristol, Cossham Hospital, Bristol, BS15 1LF UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': '5CFS/NHS Bristol, Cossham Hospital, Bristol, BS15 1LF UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Crawley', 'Affiliation': '2Bristol Medical School, University of Bristol, Bristol, BS8 1NU UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00595-0']
2332,32426178,Brain and Physiological Markers of Autonomic Function Are Associated With Treatment-Related Improvements in Self-Reported Autonomic Dysfunction in Veterans With Gulf War Illness: An Exploratory Pilot Study.,"Background


Gulf War Illness (GWI) is a poorly understood condition characterized by a constellation of mood, cognitive, and physical symptoms. A growing body of evidence demonstrates autonomic nervous system (ANS) dysfunction. Few published treatment studies exist for GWI.
Method


We recently completed a randomized controlled trial comparing a 10-week group yoga intervention to 10-week group cognitive behavioral therapy (CBT) for veterans with GWI. Here, we present exploratory data on ANS biomarkers of treatment response from a small pilot exploratory neurophysiological add-on study (n = 13) within that larger study.
Results


Findings suggest that veterans with GWI receiving either yoga or CBT for pain improved following treatment and that changes in biological ANS-especially for the yoga group-moved in the direction of healthy profiles: lower heart rate, higher square root of the mean squared differences between successive R-R intervals (RMSSD), greater parasympathetic activation/dominance (increased high-frequency heart rate variability [HF-HRV], decreased low-frequency/high-frequency [LF/HF] ratio), reduced right amygdala volume, and stronger amygdala-default mode/amygdala-salience network connectivity, both immediately posttreatment and at 6-month follow-up. Biological mechanisms of CBT appeared to underlie improvements in more psychologically loaded symptoms such as self-reported fatigue and energy. Higher tonic arousal and/or more sympathetic dominance (higher skin conductance, lower RMSSD, lower HF-HRV, higher LF/HF ratio) pretreatment predicted greater treatment-related improvements in self-reported ANS for both the yoga and CBT group.
Conclusion


These exploratory pilot data provide preliminary support for the suggestion that treatment (yoga, CBT) is associated with improvements in both biological and self-reported ANS dysfunctions in GWI. The major limitation for these findings is the small sample size. Larger and more controlled studies are needed to replicate these findings and directly compare biomarkers of yoga versus CBT.",2020,"Higher tonic arousal and/or more sympathetic dominance (higher skin conductance, lower RMSSD, lower HF-HRV, higher LF/HF ratio) pretreatment predicted greater treatment-related improvements in self-reported ANS for both the yoga and CBT group.
","['Veterans With Gulf War Illness', 'veterans with GWI']","['CBT', 'yoga intervention to 10-week group cognitive behavioral therapy (CBT']","['low-frequency/high-frequency [LF/HF] ratio), reduced right amygdala volume, and stronger amygdala-default mode/amygdala-salience network connectivity', 'heart rate', 'parasympathetic activation/dominance', 'Higher tonic arousal and/or more sympathetic dominance (higher skin conductance, lower RMSSD, lower HF-HRV, higher LF/HF ratio', 'pain']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1449761', 'cui_str': 'Persian Gulf War, 1991'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0258414,"Higher tonic arousal and/or more sympathetic dominance (higher skin conductance, lower RMSSD, lower HF-HRV, higher LF/HF ratio) pretreatment predicted greater treatment-related improvements in self-reported ANS for both the yoga and CBT group.
","[{'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'Mathersul', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Eising', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Danielle D', 'Initials': 'DD', 'LastName': 'DeSouza', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Spiegel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Bayley', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California.'}]",Global advances in health and medicine,['10.1177/2164956120922812']
2333,32424868,Polyethylene glycol versus split high-dose senna for bowel preparation: A comparative prospective randomized study.,"BACKGROUND AND AIM


The aim of this study was to compare the quality and tolerability of bowel preparation using split high-doses of sennosides versus split-dose polyethylene glycol (PEG).
METHODS


In this prospective, randomized, and endoscopist-blinded study, 474 outpatients were included and randomly assigned to two groups: Group 1 was comprised of 237 patients receiving split high-dose (1000 mg) sennoside solutions, and group 2 included 237 patients receiving 4L of PEG. The efficacy of the preparations was evaluated on the Boston Bowel Preparation Scale (BBPS), and compliance and adverse effects were recorded.
RESULTS


The quality of colon cleansing and the ease of bowel preparation were significantly better in the senna group; the mean of total BBPS scores was 7.35 in the senna group and 6.57 in the PEG group, cleansing was adequate (BBPS score≥6) in 89.9% of patients taking senna, and 73.8% in the PEG group (p=0.001). The rates of vomiting in the senna and PEG groups were 12.7% and 29.5%, nausea rates were 28.7% and 43.9%, and abdominal pain rates were 70.9% and 43%, respectively (p<0.001). Cecal intubation rates in the senna and PEG groups were 95.4% and 86.1% (p=0.001), and the cecal intubation times were 6.73±2.84 and 5.34±5.98 minutes, respectively (p=0.001).
CONCLUSIONS


Split high-dose senna is more effective than split-dose PEG in terms of bowel preparation quality and patient compliance. The patients who received senna had significantly less vomiting and nausea, but significantly more abdominal pain. Thus, senna may be used as an alternative to PEG for bowel preparation.",2020,"The quality of colon cleansing and the ease of bowel preparation were significantly better in the senna group; the mean of total BBPS scores was 7.35 in the senna group and 6.57 in the PEG group, cleansing was adequate (BBPS score≥6) in 89.9% of patients taking senna, and 73.8% in the PEG group (p=0.001).","['474 outpatients', '237 patients receiving']","['Polyethylene glycol versus split high-dose senna for bowel preparation', 'sennosides versus split-dose polyethylene glycol (PEG', '4L of PEG', 'split high-dose (1000 mg) sennoside solutions']","['quality of colon cleansing and the ease of bowel preparation', 'vomiting and nausea', 'mean of total BBPS scores', 'abdominal pain', 'Boston Bowel Preparation Scale (BBPS), and compliance and adverse effects', 'nausea rates', 'rates of vomiting', 'quality and tolerability', 'abdominal pain rates', 'cecal intubation times', 'Cecal intubation rates']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0330722', 'cui_str': 'Cassia acutifolia'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C3489575', 'cui_str': 'sennosides, USP'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",474.0,0.0705802,"The quality of colon cleansing and the ease of bowel preparation were significantly better in the senna group; the mean of total BBPS scores was 7.35 in the senna group and 6.57 in the PEG group, cleansing was adequate (BBPS score≥6) in 89.9% of patients taking senna, and 73.8% in the PEG group (p=0.001).","[{'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Coşkun', 'Affiliation': 'Department of Gastroenterology, University of Health Sciences, Diskapı Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'İlhami', 'Initials': 'İ', 'LastName': 'Yüksel', 'Affiliation': 'Department of Gastroenterology, Ankara Yildirim Beyazit University, School of Medicine, Ankara, Turkey.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15101']
2334,32424878,Effects of mindfulness-based cognitive therapy on breast cancer survivors with insomnia: A randomised controlled trial.,"OBJECTIVE


We investigated the effects of mindfulness-based cognitive therapy on insomnia (MBCT-I) in breast cancer survivors.
METHODS


In total, 136 participants were allocated randomly to a MBCT-I group or a waitlist control (WLC) group. Indicators of insomnia and mindfulness were evaluated using the Insomnia Severity Index, actigraphy and the Five Facet Mindfulness Questionnaire. Data were collected at baseline (T1), post-intervention (T2), 3-month follow-up (T3) and 6-month follow-up (T4) time points.
RESULTS


Insomnia severity decreased significantly in the MBCT-I group, compared with the WLC group, at T2, T3 and T4 (all p < .001). We found that 59.6% of the MBCT-I group with moderate and severe insomnia improved to no insomnia and subclinical insomnia at T4 relative to T1, accounting for 7.9% and 55.3%, respectively. Compared with the WLC group, the MBCT-I group improved on actigraphy measures of sleep; they exhibited a pattern of decreased sleep onset latency and waking after sleep onset, as well as increased total sleep time and sleep efficiency. Mindfulness also increased more in the MBCT-I group than in the WLC group at T2, T3 and T4 (all p < .001).
CONCLUSIONS


MBCT-I may be an efficacious non-pharmacologic intervention to improve sleep quality in breast cancer survivors.",2020,"RESULTS


Insomnia severity decreased significantly in the MBCT-I group, compared with the WLC group, at T2, T3 and T4 (all p < .001).","['breast cancer survivors with insomnia', 'breast cancer survivors', '136 participants']","['MBCT-I group or a waitlist control (WLC', 'MBCT', 'mindfulness-based cognitive therapy', 'WLC']","['insomnia and subclinical insomnia', 'severe insomnia', 'total sleep time and sleep efficiency', 'Insomnia Severity Index, actigraphy and the Five Facet Mindfulness Questionnaire', 'sleep quality', 'actigraphy measures of sleep', 'Insomnia severity']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4517568', 'cui_str': '136'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",136.0,0.0365461,"RESULTS


Insomnia severity decreased significantly in the MBCT-I group, compared with the WLC group, at T2, T3 and T4 (all p < .001).","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Nursing, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jun-E', 'Initials': 'JE', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, Capital Medical University, Beijing, China.'}, {'ForeName': 'Frances Marcus', 'Initials': 'FM', 'LastName': 'Lewis', 'Affiliation': 'School of Nursing, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Zhi-Hong', 'Initials': 'ZH', 'LastName': 'Nie', 'Affiliation': 'School of Nursing, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': 'School of Nursing, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'School of Nursing, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ya-Li', 'Initials': 'YL', 'LastName': 'Su', 'Affiliation': 'Breast center, Breast Cancer Center, Beijing Tiantan Hospital affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'Shen-Shen', 'Initials': 'SS', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, Capital Medical University, Beijing, China.'}]",European journal of cancer care,['10.1111/ecc.13259']
2335,32424935,Liraglutide Treatment in Overweight and Obese Patients with Type 1 Diabetes: A 26 weeks Randomized Controlled Trial.,"BACKGROUND


We have previously demonstrated that a 12-week addition of liraglutide to insulin therapy in patients with type 1 diabetes (T1DM) results in an improvement in glycemic control, weight loss and a reduction in systolic blood pressure (SBP). We now investigated effects of liraglutide treatments on glycemic control and adipose tissue metabolism in overweight and obese T1DM patients.
RESEARCH DESIGN AND METHODS


84 adult overweight and obese TIDM with no detectable c-peptide were randomized (1:1) to with either placebo or 1.8 mg/day liraglutide for 6 months. Blood samples were collected at 0, 12 and 26 weeks. Subcutaneous adipose tissue biopsies, high calorie high fat (HCHF) meal, CGM, DEXA and MRI were performed before and at end of treatment.
RESULTS


37 and 27 patients who received liraglutide or placebo, respectively, completed the study. HbA1c fell by 0.41 ± 0.18% from baseline following liraglutide (p = 0.001) and by 0.29 ± 0.19% compared to placebo (p = 0.1). There was no increase in hypoglycemia while the time spent in normal glycemia increased (p = 0.015) and time spent in hyperglycemia decreased (p = 0.019). Body weight fell significantly following liraglutide mostly in the form of fat mass loss (including visceral fat) with no change in lean mass. SBP also fell following liraglutide treatment. Liraglutide also caused a significant increase in the expression of ATGL, CPT-1, PPARα, PPARδ, UCP-2 and Dio-2 in the adipose tissue.
CONCLUSIONS


Liraglutide improves glycemia, reduces adiposity and SBP. Liraglutide also stimulates mechanisms involved with an increase in lipid oxidation and thermogenesis while conserving lean body mass. This article is protected by copyright. All rights reserved.",2020,There was no increase in hypoglycemia while the time spent in normal glycemia increased (p = 0.015) and time spent in hyperglycemia decreased (p = 0.019).,"['adult overweight and obese', 'overweight and obese T1DM patients', '37 and 27 patients who received', 'patients with type 1 diabetes (T1DM', 'Overweight and Obese Patients with Type 1 Diabetes', '84']","['liraglutide', 'Liraglutide', 'liraglutide or placebo', 'Subcutaneous adipose tissue biopsies, high calorie high fat (HCHF) meal, CGM, DEXA', 'placebo']","['time spent in hyperglycemia', 'expression of ATGL, CPT-1, PPARα, PPARδ, UCP-2 and Dio-2 in the adipose tissue', 'lipid oxidation and thermogenesis', 'Blood samples', 'glycemic control, weight loss', 'hypoglycemia while the time spent in normal glycemia', 'Body weight', 'glycemic control and adipose tissue metabolism', 'systolic blood pressure (SBP', 'glycemia, reduces adiposity and SBP', 'SBP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007262', 'cui_str': 'Carnitine palmitoyltransferase'}, {'cui': 'C0854076', 'cui_str': 'Distal ileal obstruction syndrome'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",84.0,0.0906694,There was no increase in hypoglycemia while the time spent in normal glycemia increased (p = 0.015) and time spent in hyperglycemia decreased (p = 0.019).,"[{'ForeName': 'Husam', 'Initials': 'H', 'LastName': 'Ghanim', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo.'}, {'ForeName': 'Manav', 'Initials': 'M', 'LastName': 'Batra', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Green', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo.'}, {'ForeName': 'Sanaa', 'Initials': 'S', 'LastName': 'Abuaysheh', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Hejna', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo.'}, {'ForeName': 'Antione', 'Initials': 'A', 'LastName': 'Makdissi', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Borowski', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo.'}, {'ForeName': 'Nitesh', 'Initials': 'N', 'LastName': 'Kuhadiya', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Chaudhuri', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Dandona', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14090']
2336,31104490,"Automated Feedback Messages With Shichifukujin Characters Using IoT System-Improved Glycemic Control in People With Diabetes: A Prospective, Multicenter Randomized Controlled Trial.",,2019,,['People With Diabetes'],"['Automated Feedback Messages', 'Shichifukujin Characters Using IoT System-Improved Glycemic Control']",[],[],"[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.151882,,"[{'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': '1 Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kazuyo', 'Initials': 'K', 'LastName': 'Tsushita', 'Affiliation': '2 Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation, Aichi, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Nomura', 'Affiliation': '2 Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation, Aichi, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Muramoto', 'Affiliation': '2 Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation, Aichi, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Kato', 'Affiliation': '2 Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation, Aichi, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Eguchi', 'Affiliation': '2 Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation, Aichi, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Onoue', 'Affiliation': '1 Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Motomitsu', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': '1 Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Muto', 'Affiliation': '3 Seirei Center for Health Promotion and Preventive Medicine, Shizuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yatsuya', 'Affiliation': '4 Department of Public Health, Fujita health University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': '1 Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}]",Journal of diabetes science and technology,['10.1177/1932296819851785']
2337,32425482,Gall Bladder Empyema: Early Cholecystectomy during the Index Admission Improves Outcomes.,"Objectives


We aim to evaluate our policy of index admission management of gall bladder empyema and the effect of the timing of surgery on the outcomes.
Methods


We analyzed a series of 5400 laparoscopic cholecystectomies. Data were collected prospectively over 26 y. Patients were divided into two groups: group 1, intervention within 72 h, and group 2, intervention after 72 h of admission. We had a policy of intention to treat during the index admission, but delays sometimes occurred because of late referral, a need to optimize patients, availability of theater time, or the biliary surgeon being on leave. The groups were then compared with regard to the duration of surgery, the difficulty grading, complications, hospital stay, and conversion rate.
Results


A total of 372 patients were included; 160 (43%) operated on within 72 h (group 1) and 212 (57%) after 72 h (group 2). There was no statistically significant difference between the two groups with regard to the operation time, conversion rate, and complications rate. The difference in total hospital stay was, however, statistically significant.
Conclusion


Surgical management of empyema should be offered as soon as possible after admission as with any acute cholecystitis. Surgery carried out after 72 h of admission is only associated with longer hospital stay but no statistically significant differences in other outcome parameters. In the presence of specialist expertise, fitness for surgery should be the determining factor of whether or not to offer surgery to these patients, regardless of the interval since their admission.",2020,"There was no statistically significant difference between the two groups with regard to the operation time, conversion rate, and complications rate.","['5400 laparoscopic cholecystectomies', 'Gall Bladder Empyema', 'A total of 372 patients were included; 160 (43%) operated on within 72 h (group 1) and 212 (57%) after 72 h (group 2']",[],"['difficulty grading, complications, hospital stay, and conversion rate', 'longer hospital stay', 'operation time, conversion rate, and complications rate', 'total hospital stay']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0014012', 'cui_str': 'Empyema of gallbladder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]",[],"[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",372.0,0.051755,"There was no statistically significant difference between the two groups with regard to the operation time, conversion rate, and complications rate.","[{'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'El Zanati', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Ahmad H M', 'Initials': 'AHM', 'LastName': 'Nassar', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Zino', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Katbeh', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Hwei Jene', 'Initials': 'HJ', 'LastName': 'Ng', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Abdellatif', 'Affiliation': 'Department of General Surgery, University Hospital Monklands, Airdrie, Lanarkshire, United Kingdom.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00015']
2338,32425692,Telephonic nursing intervention for laparoscopic cholecystectomy and hernia repair: A randomized controlled study.,"Background


Patient undergoing surgery may be afraid and concerned about the diagnosis, the treatment, the procedure, the postoperative care, and the surgical recovery. Good communication between staff and patients can minimize or prevent this situation. This study aimed to evaluate the effectiveness of a Telecare nursing intervention, ""Telephone consultation"", in reducing the ""Delayed surgical recovery"" nursing diagnosis in patients undergoing laparoscopic cholecystectomy and hernia repair.
Methods


This study was performed in two different institutions located in Rio de Janeiro, Brazil. A total of 43 patients were enrolled. The experimental group consisted of 22 patients who had access to the telephone follow-up intervention, and the control group consisted of 21 patients who received conventional treatment without telephone follow-up. This was a randomized controlled study with patients who were 60 years or older and awaiting operative procedures of hernia repair and laparoscopic cholecystectomy who had a mobile or landline phone and were available for telephone contact.
Results


There was a reduction in ""loss of appetite with nausea"" ( p  = 0.013); ""need help to complete self-care"" ( p  = 0.041); ""pain"" ( p  = 0.041); and ""postoperative sensation"" ( p  = 0.023). The experimental group showed a significantly larger decrease in factors related to the ""Delayed surgical recovery"" diagnosis, suggesting a positive effect of the intervention compared to the effect in control group.\.
Conclusion


Telephone consultation identified factors that increased the risk of complications after surgery, recognized potential patients for delayed surgical recovery and helped perioperative nurses provide accurate interventions to prevent or mitigate delayed recovery.This study was registered in the platform Brazilian Registry of Clinical Trials (ReBEC) - link: http://www.ensaiosclinicos.gov.br under registration number RBR-4C249M, retrospectively registered on April 13, 2020.",2020,"There was a reduction in ""loss of appetite with nausea"" ( p  = 0.013); ""need help to complete self-care"" ( p  = 0.041); ""pain"" ( p  = 0.041); and ""postoperative sensation"" ( p  = 0.023).","['two different institutions located in Rio de Janeiro, Brazil', '43 patients were enrolled', 'patients undergoing laparoscopic cholecystectomy and hernia repair', '22 patients who had access to the telephone follow-up intervention, and the control group consisted of 21 patients who received', 'laparoscopic cholecystectomy and hernia repair', 'patients who were 60\u2009years or older and awaiting operative procedures of hernia repair and laparoscopic cholecystectomy who had a mobile or landline phone and were available for telephone contact']","['conventional treatment without telephone follow-up', 'Telephonic nursing intervention', 'Telecare nursing intervention, ""Telephone consultation']","['risk of complications', 'pain', 'postoperative sensation', 'loss of appetite with nausea']","[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0445581', 'cui_str': 'Rio'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0175745', 'cui_str': 'Telephone consultation'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",43.0,0.0567354,"There was a reduction in ""loss of appetite with nausea"" ( p  = 0.013); ""need help to complete self-care"" ( p  = 0.041); ""pain"" ( p  = 0.041); and ""postoperative sensation"" ( p  = 0.023).","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'da Silva Schulz', 'Affiliation': '1Jorge Amado University, Salvador, BA Brazil.'}, {'ForeName': 'Rosimere Ferreira', 'Initials': 'RF', 'LastName': 'Santana', 'Affiliation': '2Federal Fluminense University, CNPq researcher, Rio de Janeiro, Brazil.'}, {'ForeName': 'Carla Targino Bruno', 'Initials': 'CTB', 'LastName': 'Dos Santos', 'Affiliation': '4University of Brasilia, Federal District, Brasilia, Brazil.'}, {'ForeName': 'Thiago Batista', 'Initials': 'TB', 'LastName': 'Faleiro', 'Affiliation': 'Clinical Hospital of Salvador, Brasilia, BA Brazil.'}, {'ForeName': 'Dayana Medeiros', 'Initials': 'DM', 'LastName': 'do Amaral Passarelles', 'Affiliation': '6Fluminense Federal University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Ana Beatriz Serra', 'Initials': 'ABS', 'LastName': 'Hercules', 'Affiliation': '6Fluminense Federal University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Thalita Gomes', 'Initials': 'TG', 'LastName': 'do Carmo', 'Affiliation': '2Federal Fluminense University, CNPq researcher, Rio de Janeiro, Brazil.'}]",BMC nursing,['10.1186/s12912-020-00432-y']
2339,32425976,Combining Bioinformatics Techniques to Study Diabetes Biomarkers and Related Molecular Mechanisms.,"Objective


To explore the mechanism of plasma circulating miRNA-126 and miRNA-28-3p in diabetes mellitus (DM) patients, and to identify the related bioinformatics analysis.
Methods


Randomly selected 120 DM patients as the observation group and 120 non- DM patients as the control group. The plasma circulating miRNA-126 and miRNA-28-3p were analyzed by qRT-PCR, and their target genes, biological information, related lncRNA and circRNA were predicted.
Results


The circulating miRNA-126 (0.1162 ± 0.0236 vs. 0.0018 ± 0.0862) and miRNA-28-3p (0.1378 ± 0.0268 vs. 0.0006 ± 0.0167) levels in the observation group were significantly higher than those in the control group, and differences were statistically significant ( P  < 0.01). The Pearson correlation coefficient of miRNA-126 and miRNA- 28-3p was 0.4337 ( P  < 0.01). ROC curve analysis of miRNA-126 and miRNA-28-3p showed that the differences of the area under curve were statistically significant between the two groups ( P  < 0.01). Bioinformatics prediction showed that miRNA-126 and miRNA-28-3p may be involved in regulation of the insulin signaling pathway, insulin receptor signaling pathway, insulin/insulin growth factor signaling pathway, mitogen-activated protein kinase (MAPK) signaling pathway and angiogenesis. Moreover, it may be associated with a variety of lncRNA and cir-cRNA.
Conclusion


Circulating miRNA-126 and miRNA-28-3p can be a potential biomarker of DM and it may play an important role in the DM by regulating insulin or insulin growth factor related signaling pathways.",2020,"The circulating miRNA-126 (0.1162 ± 0.0236 vs. 0.0018 ± 0.0862) and miRNA-28-3p (0.1378 ± 0.0268 vs. 0.0006 ± 0.0167) levels in the observation group were significantly higher than those in the control group, and differences were statistically significant ( P  < 0.01).","['diabetes mellitus (DM) patients', '120 DM patients as the observation group and 120 non- DM patients as the control group']",[],[],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],[],120.0,0.0254576,"The circulating miRNA-126 (0.1162 ± 0.0236 vs. 0.0018 ± 0.0862) and miRNA-28-3p (0.1378 ± 0.0268 vs. 0.0006 ± 0.0167) levels in the observation group were significantly higher than those in the control group, and differences were statistically significant ( P  < 0.01).","[{'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Nie', 'Affiliation': 'Department of Vascular Surgery, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Kaihua', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Jiujiang Hospital Affiliated to Nanchang University, Nanchang, China.'}, {'ForeName': 'Jiasheng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Vascular Surgery, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Kaili', 'Initials': 'K', 'LastName': 'Liao', 'Affiliation': 'Department of Clinical Laboratory, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Vascular Surgery, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Zhonghua', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Burns, The First Affiliated Hospital of Nanchang University, Nanchang, China.'}]",Frontiers in genetics,['10.3389/fgene.2020.00367']
2340,32426135,Re-inhabiting one's body: A pilot study on the effects of dance movement therapy on body image and alexithymia in eating disorders.,"Background


Body image disturbance and alexithymia are two core aspects of Eating Disorders (EDs). However, standard treatments for EDs do not include specific techniques to approach these issues on a bodily level. This pilot study evaluated the effects of a Dance Movement Therapy (DMT) intervention on body image and alexithymia in patients with EDs, and also explored their experience of the therapeutic process.
Method


14 patients with EDs were recruited from a private clinic. Seven were assigned via quasi-randomization to the DMT group and the others ( n  = 5) continued their treatment as usual. The length of the intervention was 14 weeks. All participants completed the Multidimensional Body Self Relations Questionnaire (MBSRQ) and the Toronto Alexithymia Scale (TAS-20) at the beginning and at the end of the intervention. Additionally, the DMT group wrote reflective diaries about their experience at the end of each session, which were analyzed using qualitative methods.
Results


Between the pre- and post-intervention, the participants of the DMT group significantly improved in Body Areas Satisfaction (effect size: 0.95) and Appearance Evaluation (effect size: 1.10), and they decreased significantly in Appearance Orientation (effect size: 1.30). A decrease in Overweight Preoccupation was observed (effect size: 0.75), however this was not statistically significant. The control group did not show significant changes in any of the MBSRQ subscales. Neither the DMT group nor the control group improved significantly in the alexithymia scores. The qualitative analysis revealed valuable insights into the participants' processes throughout the sessions. In general, participants received the DMT intervention positively. They reported improvements in their mood states and an increase in their self-awareness. They also appreciated the relationship with the group and the therapist.
Conclusion


These results indicate that DMT might be a complementary treatment option for EDs, as it may be able to address body image issues more effectively than verbal therapies. More studies with larger samples are needed to confirm these promising preliminary results.",2020,"A decrease in Overweight Preoccupation was observed (effect size: 0.75), however this was not statistically significant.","['patients with EDs', '14 patients with EDs were recruited from a private clinic', 'eating disorders']","[""Re-inhabiting one's body"", 'DMT intervention', 'Dance Movement Therapy (DMT) intervention', 'DMT', 'dance movement therapy']","['MBSRQ subscales', 'Body Areas Satisfaction', 'Overweight Preoccupation', 'alexithymia scores', 'Appearance Orientation', 'Multidimensional Body Self Relations Questionnaire (MBSRQ) and the Toronto Alexithymia Scale (TAS-20', 'body image and alexithymia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0549165', 'cui_str': 'Preoccupation'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]",14.0,0.021764,"A decrease in Overweight Preoccupation was observed (effect size: 0.75), however this was not statistically significant.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Savidaki', 'Affiliation': '1Psychology Department, Autonomus University of Barcelona, Plaça Cívica, Barcelona, 08193 Spain.'}, {'ForeName': 'Sezin', 'Initials': 'S', 'LastName': 'Demirtoka', 'Affiliation': '1Psychology Department, Autonomus University of Barcelona, Plaça Cívica, Barcelona, 08193 Spain.'}, {'ForeName': 'Rosa-María', 'Initials': 'RM', 'LastName': 'Rodríguez-Jiménez', 'Affiliation': '2Universidad Europea de Madrid, c/Tajo, s/n, Villaviciosa de Odón, Madrid, 28670 Spain.'}]",Journal of eating disorders,['10.1186/s40337-020-00296-2']
2341,32426153,"Evaluation of a web-based, tailored intervention to encourage help-seeking for lung cancer symptoms: a randomised controlled trial.","Background


People with lung cancer often wait for several months before presenting symptoms to health services. Some patients report seeking information online to help them appraise symptoms. No research has evaluated whether websites about lung cancer present information in an optimal manner to encourage help-seeking.
Objective


To evaluate the effectiveness of an online, tailored, theory-based intervention in encouraging help-seeking behaviour among people with potential lung cancer symptoms.
Methods


The intervention consisted of a specialised website which provided tailored information about lung cancer and included a component to address beliefs about help-seeking, based on the Theory of Planned Behaviour (TPB-component). Individuals with undiagnosed symptoms were randomised to receive information about lung cancer in a factorial design (tailored/untailored × TPB-component/no TPB-component). Pre and post viewing webpages, participants reported perceived likelihood of seeking help. Data were analysed using robust mixed factorial ANOVA.
Results


Data from 253 participants (73.9% female) were analysed. No effect for the TPB-component was found ( p  = 0.16), nor for tailoring ( p  = 0.27). Self-reported likelihood of seeking help increased significantly from pre to post ( p  < 0.001), regardless of tailoring and TPB-components.
Conclusion


Self-reported likelihood of seeking help for potential lung cancer symptoms may increase after viewing information online. This does not appear to be affected by information tailoring and components to address beliefs. However, intentions remained unchanged in the majority of the sample. This suggests further efforts are needed to improve lung cancer websites if they are to be a useful resource for those seeking advice about their symptoms.",2020,"Self-reported likelihood of seeking help increased significantly from pre to post ( p  < 0.001), regardless of tailoring and TPB-components.
","['people with potential lung cancer symptoms', 'Individuals with undiagnosed symptoms', '253 participants (73.9% female', 'lung cancer symptoms']","['online, tailored, theory-based intervention', 'specialised website which provided tailored information about lung cancer and included a component to address beliefs about help-seeking, based on the Theory of Planned Behaviour (TPB-component']","['Self-reported likelihood of seeking help', 'TPB-component']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",253.0,0.0367486,"Self-reported likelihood of seeking help increased significantly from pre to post ( p  < 0.001), regardless of tailoring and TPB-components.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mueller', 'Affiliation': 'School of Health Sciences, University of Manchester, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': 'School of Computer Science, University of Manchester, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Jay', 'Affiliation': 'School of Computer Science, University of Manchester, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Harper', 'Affiliation': 'School of Computer Science, University of Manchester, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Todd', 'Affiliation': 'School of Health Sciences, University of Manchester, UK.'}]",Digital health,['10.1177/2055207620922381']
2342,32426158,Feasibility of an implementation intervention to increase attendance at diabetic retinopathy screening: protocol for a cluster randomised pilot trial.,"Background


Diabetic retinopathy screening (DRS) leads to the earlier detection of retinopathy and treatment that can prevent or delay the development of diabetes-related blindness. However, uptake continues to be sub-optimal in many countries, including Ireland. Routine management of type 2 diabetes largely takes place in primary care. As such, there may be an opportunity in primary care to introduce interventions to improve DRS uptake. However, few studies test the feasibility of interventions to enhance DRS uptake in this context. Our aim is to investigate the feasibility of an implementation intervention (IDEAs (Improving Diabetes Eye screening Attendance)) delivered in general practice to improve the uptake of the national DRS programme, RetinaScreen.
Methods


The IDEAs study is a cluster randomised pilot trial with an embedded process evaluation and economic evaluation. Following stratification by practice size, eight general practices (clusters) will be randomly allocated to intervention ( n  = 4) or wait-list control groups ( n  = 4). The intervention will be delivered for 6 months, after which, it will be administered to wait-list control practices. The intervention is multi-faceted and comprises provider-level components (training, audit and feedback, health care professional prompt, reimbursement) and patient-level components (GP-endorsed reminder with information leaflet delivered opportunistically face-to-face, and systematically by phone and letter). Patient inclusion criteria are type 1 or type 2 diabetes and DRS programme non-attendance. A multi-method approach will be used to determine screening uptake, evaluate the trial and study procedures and examine the acceptability and feasibility of the intervention from staff and patient perspectives. Quantitative and qualitative data will be collected on intervention uptake and delivery, research processes and outcomes. Data will be collected at the practice, health professional and patient level. A partial economic evaluation will be conducted to estimate the cost of delivering the implementation intervention in general practice. Formal continuation criteria will be used to determine whether IDEAs should progress to a definitive trial.
Discussion


Findings will determine whether IDEAsis feasible and acceptable and will be used to refine the intervention and study procedures. A definitive trial will determine whether IDEAs is a cost-effective intervention to improve DRS uptake and reduce diabetes-related blindness.
Trial registration


ClinicalTrials.gov NCT03901898. Registered 3rd April 2019.",2020,"A definitive trial will determine whether IDEAs is a cost-effective intervention to improve DRS uptake and reduce diabetes-related blindness.
",['Patient inclusion criteria are type 1 or type 2 diabetes and DRS programme non-attendance'],"['implementation intervention', 'implementation intervention (IDEAs (Improving Diabetes Eye screening Attendance', '\n\n\nDiabetic retinopathy screening (DRS', 'patient-level components (GP-endorsed reminder with information leaflet delivered opportunistically face-to-face, and systematically by phone and letter']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C1277181', 'cui_str': 'Diabetic retinopathy screening'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0459920', 'cui_str': 'Ability to think abstractly'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1277181', 'cui_str': 'Diabetic retinopathy screening'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]",[],,0.115213,"A definitive trial will determine whether IDEAs is a cost-effective intervention to improve DRS uptake and reduce diabetes-related blindness.
","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Riordan', 'Affiliation': '1School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}, {'ForeName': 'Emmy', 'Initials': 'E', 'LastName': 'Racine', 'Affiliation': '1School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': '2Department of General Practice, Royal College of Surgeons of Ireland, Dublin, Ireland.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Murphy', 'Affiliation': '3Department of Economics, Cork University Business School, University College Cork, Cork, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Browne', 'Affiliation': '1School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': '1School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Bradley', 'Affiliation': '4Department of General Practice, University College Cork, Cork, Ireland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'James', 'Affiliation': '5Medical Education Unit, University College Cork, Cork, Ireland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Murphy', 'Affiliation': '2Department of General Practice, Royal College of Surgeons of Ireland, Dublin, Ireland.'}, {'ForeName': 'Sheena M', 'Initials': 'SM', 'LastName': 'McHugh', 'Affiliation': '1School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00608-y']
2343,32426189,Diurnal Variation in Outcomes of Percutaneous Coronary Intervention.,"Objectives To determine whether the outcomes differ during regular hours as compared to off hours in patients with acute myocardial infarction who undergo primary percutaneous coronary intervention. Methods We conducted a prospective, interventional study of patients who presented to a specialized cardiac care center. Patients who satisfied the inclusion and exclusion criteria were included in the study. They were divided into two groups so that one group received intervention during regular working hours while the other group received intervention during 'off' hours. The data was collected through a self-constructed questionnaire. Cronbach's alpha was used to assess the internal consistency of the questionnaire, and it was found to be 0.75. The data obtained was analyzed on IBM's Statistical Package for the Social Sciences (SPSS) version 21.0 (IBM, Armonk, NY). Results Out of 100 participants, 64 (64%) were males and 36 (36%) were females. The mean age of the participants was 58.58 ± 13.21 years. Most (44%) of the patients were diabetic. Inferior wall myocardial infarcts were more common in our study. Percutaneous intervention during 'off' hours was associated with more adverse outcomes. The differences in gender and angina requiring revascularization were statistically significant (p-value<0.05). Conclusion No significant difference in outcomes was observed in both groups of patients. Metacentric data from different institutes should be gathered for a comprehensive insight on this topic where door-to-balloon times and initiation of catheterization lab procedures are practiced in different ways.",2020,No significant difference in outcomes was observed in both groups of patients.,"['The mean age of the participants was 58.58 ± 13.21 years', '100 participants, 64 (64%) were males and 36 (36%) were females', 'patients who presented to a specialized cardiac care center', 'Patients who satisfied the inclusion and exclusion criteria were included in the study', 'patients with acute myocardial infarction who undergo primary percutaneous coronary intervention']","['Percutaneous Coronary Intervention', 'Percutaneous intervention']","['gender and angina requiring revascularization', 'adverse outcomes']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",100.0,0.0264386,No significant difference in outcomes was observed in both groups of patients.,"[{'ForeName': 'Jahanzeb', 'Initials': 'J', 'LastName': 'Malik', 'Affiliation': 'Cardiology, Rawalpindi Institute of Cardiology, Rawalpindi, PAK.'}, {'ForeName': 'Nismat', 'Initials': 'N', 'LastName': 'Javed', 'Affiliation': 'Internal Medicine, Shifa College of Medicine, Shifa Tameer-E-Millat University, Islamabad, PAK.'}]",Cureus,['10.7759/cureus.7677']
2344,24521459,Benefits of repeated individual dietary counselling in long-term weight control in women after delivery.,"As pregnancy may trigger overweight in women, new means for its prevention are being sought. The aim here was to investigate the effect of individual dietary counselling during and after pregnancy on post-partum weight and waist circumference up to 4 years post-partum. A cohort of women (n = 256) were randomized to receive repeated individual dietary counselling by a nutritionist during and after pregnancy, or as controls not receiving dietary counselling, from the first trimester of pregnancy until 6 months after delivery. Counselling aimed to bring dietary intake into line with recommendations, with particular focus on the increase in the intake of unsaturated fatty acids instead of saturated. Pre-pregnancy weight was taken from welfare clinic records. Weight and waist circumference were measured at 4 years after delivery. The proportion of overweight women increased from 26% prior to pregnancy to 30% at 4 years after delivery among women receiving dietary counselling, as against considerably more, from 32% to 57%, among controls. The prevalence of central adiposity was 31% in women receiving dietary counselling, 64% in controls. Likewise, both the risk of overweight (odds ratio: 0.23, 0.08-0.63, P = 0.005) and central adiposity (odds ratio: 0.18, 0.06-0.52, P = 0.002) were lower in women receiving dietary counselling compared with controls. Repeated dietary counselling initiated in early pregnancy can be beneficial in long-term weight control after delivery.",2015,"Likewise, both the risk of overweight (odds ratio: 0.23, 0.08-0.63, P = 0.005) and central adiposity (odds ratio: 0.18, 0.06-0.52, P = 0.002) were lower in women receiving dietary counselling compared with controls.","['women after delivery', 'A cohort of women (n\u2009=\u2009256']","['repeated individual dietary counselling', 'Repeated dietary counselling', 'repeated individual dietary counselling by a nutritionist during and after pregnancy, or as controls not receiving dietary counselling', 'individual dietary counselling']","['Weight and waist circumference', 'proportion of overweight women', 'pregnancy weight', 'central adiposity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0237083', 'cui_str': 'Nutritionist'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}]",256.0,0.0347974,"Likewise, both the risk of overweight (odds ratio: 0.23, 0.08-0.63, P = 0.005) and central adiposity (odds ratio: 0.18, 0.06-0.52, P = 0.002) were lower in women receiving dietary counselling compared with controls.","[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Jaakkola', 'Affiliation': 'Department of Clinical Sciences, University of Turku, Finland.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Isolauri', 'Affiliation': 'Department of Clinical Sciences, University of Turku, Finland.'}, {'ForeName': 'Tuija', 'Initials': 'T', 'LastName': 'Poussa', 'Affiliation': 'Stat-Consulting, Nokia, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Laitinen', 'Affiliation': 'Functional Foods Forum, University of Turku, Finland.'}]",Maternal & child nutrition,['10.1111/mcn.12115']
2345,24521353,"Effectiveness of milk whey protein-based ready-to-use therapeutic food in treatment of severe acute malnutrition in Malawian under-5 children: a randomised, double-blind, controlled non-inferiority clinical trial.","The cost of ready-to-use therapeutic food (RUTF) used in community-based management of acute malnutrition has been a major obstacle to the scale up of this important child survival strategy. The current standard recipe for RUTF [peanut-based RUTF (P-RUTF)] is made from peanut paste, milk powder, oil, sugar, and minerals and vitamins. Milk powder forms about 30% of the ingredients and may represent over half the cost of the final product. The quality of whey protein concentrates 34% (WPC34) is similar to that of dried skimmed milk (DSM) used in the standard recipe and can be 25-33% cheaper. This blinded, parallel group, randomised, controlled non-inferiority clinical trial tested the effectiveness in treating severe acute malnutrition (SAM) of a new RUTF formulation WPC-RUTF in which WPC34 was used to replace DSM. Average weight gain (non-inferiority margin Δ = -1.2 g kg(-1) day(-1) ) and recovery rate (Δ = -10%) were the primary outcomes, and length of stay (LOS) was the secondary outcome (Δ = +14 days). Both per-protocol (PP) and intention-to-treat (ITT) analyses showed that WPC-RUTF was not inferior to P-RUTF for recovery rate [difference and its 95% confidence interval (CI) of 0.5% (95% CI -2.7, 3.7) in PP analysis and 0.6% (95% CI -5.2, 6.3) in ITT analysis] for average weight gain [0.2 (-0.5; 0.9) for both analyses] and LOS [-1.6 days (95% CI, -4.6, 1.4 days) in PP analysis and -1.9 days (95% CI, -4.6, 0.8 days) for ITT analysis]. In conclusion, whey protein-based RUTF is an effective cheaper alternative to the standard milk-based RUTF for the treatment of SAM.",2014,The cost of ready-to-use therapeutic food (RUTF) used in community-based management of acute malnutrition has been a major obstacle to the scale up of this important child survival strategy.,"['severe acute malnutrition (SAM', 'severe acute malnutrition in Malawian under-5 children']","['milk whey protein-based ready-to-use therapeutic food', 'whey protein-based RUTF', 'g kg(-1', 'dried skimmed milk (DSM', 'RUTF [peanut-based RUTF (P-RUTF']","['Average weight gain', 'LOS', 'length of stay (LOS', 'recovery rate', 'average weight gain']","[{'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0349375', 'cui_str': 'Skim milk'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.273888,The cost of ready-to-use therapeutic food (RUTF) used in community-based management of acute malnutrition has been a major obstacle to the scale up of this important child survival strategy.,"[{'ForeName': 'Paluku', 'Initials': 'P', 'LastName': 'Bahwere', 'Affiliation': 'Valid International, Oxford, UK; Centre of Research in Epidemiology, Biostatistics and Clinical Research, School of Public Health, Free University of Brussels, Brussels, Belgium.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Banda', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sadler', 'Affiliation': ''}, {'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'Nyirenda', 'Affiliation': ''}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Owino', 'Affiliation': ''}, {'ForeName': 'Bina', 'Initials': 'B', 'LastName': 'Shaba', 'Affiliation': ''}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Dibari', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/mcn.12112']
2346,24760534,Pilot clinical study of the effects of ginger root extract on eicosanoids in colonic mucosa of subjects at increased risk for colorectal cancer.,"Colorectal cancer (CRC) remains a significant cause of mortality. Inhibitors of cyclooxygenase (COX) and thus prostaglandin E2, are promising CRC preventives, but have significant toxicities. Ginger has been shown to inhibit COX, to decrease the incidence and multiplicity of adenomas, and decrease PGE2 concentrations in subjects at normal risk for CRC. This study was conducted to determine the effects of 2.0 g/d of ginger given orally on the levels of PGE2, leukotriene B4 (LTB4), 13-hydroxy-octadecadienoic acids, and 5-, 12-, & 15-hydroxyeicosatetraenoic acid, in the colonic mucosa of subjects at increased risk for CRC. We randomized 20 subjects to 2.0 g/d ginger or placebo for 28 d. At baseline and Day 28, a flexible sigmoidoscopy was used to obtain colon biopsies. A liquid chromatography mass spectrometry method was used to determine eicosanoid levels in the biopsies, and levels were expressed per amount of protein or free arachidonic acid (AA). There was a significant decrease in AA between baseline and Day 28 (P = 0.05) and significant increase in LTB4 (P = 0.04) when normalized to protein, in subjects treated with ginger versus placebo. No other changes in eicosanoids were observed. There was no difference between the groups in total adverse events (AE; P = 0.06). Ginger lacks the ability to decrease eicosanoid levels in people at increased risk for CRC. Ginger did appear to be both tolerable and safe; and could have chemopreventive effects through other mechanisms. Further investigation should focus on other markers of CRC risk in those at increased CRC risk.",2015,There was no difference between the groups in total adverse events (AE; P = 0.06).,"['Colorectal cancer (CRC', 'colonic mucosa of subjects at increased risk for colorectal cancer']","['placebo', 'ginger root extract', 'flexible sigmoidoscopy', 'cyclooxygenase (COX', 'd ginger or placebo']","['PGE2 concentrations', 'AA', 'levels of PGE2, leukotriene B4 (LTB4), 13-hydroxy-octadecadienoic acids, and 5-, 12-, & 15-hydroxyeicosatetraenoic acid', 'tolerable and safe', 'LTB4', 'eicosanoid levels', 'total adverse events']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0453260', 'cui_str': 'ginger root'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy (procedure)'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin H2 Synthetase'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}]","[{'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023546', 'cui_str': 'Leukotriene B-4'}, {'cui': 'C0069315', 'cui_str': 'octadecadienoic acid'}, {'cui': 'C0020349', 'cui_str': 'HETE'}, {'cui': 'C0013725', 'cui_str': 'Eicosanoids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",20.0,0.0588503,There was no difference between the groups in total adverse events (AE; P = 0.06).,"[{'ForeName': 'Suzanna M', 'Initials': 'SM', 'LastName': 'Zick', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'D Kim', 'Initials': 'DK', 'LastName': 'Turgeon', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Mack T', 'Initials': 'MT', 'LastName': 'Ruffin', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Wright', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Zora', 'Initials': 'Z', 'LastName': 'Djuric', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Dean E', 'Initials': 'DE', 'LastName': 'Brenner', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}]",Molecular carcinogenesis,['10.1002/mc.22163']
2347,24603217,The effect of moderate-dose versus double-dose statins on patients with acute coronary syndrome in China: Results of the CHILLAS trial.,"BACKGROUND


Current guidelines recommend intensive low-density lipoprotein (LDL) cholesterol lowering with statins, with a target of 70 mg/dL (1.81 mmol/L) LDL cholesterol for those with a very high risk of coronary artery events. However, there is no multicenter study assessing the effect of intensive lipid-lowering therapy with statins on acute coronary syndrome (ACS) in a Chinese population with low baseline LDL cholesterol levels.
METHODS AND RESULTS


Patients (n=1355) with ACS were treated with a moderate dose of statin (atorvastatin 10 mg/d, or equivalent dose of other statins, n=675) or with an intensive dose of statin (atorvastatin, 20 or 40 mg/d, or equivalent dose of other statins, n=680) for 2 years. The primary end points were cardiac death, non-fatal acute myocardial infarction (MI), revascularization, ischemic stroke and documented unstable angina or severe heart failure requiring emergency hospitalization. Baseline lipid levels were nearly identical in both groups with a mean LDL cholesterol level of 2.7 mmol/L (103 mg/dL). At 3 months, LDL cholesterol levels declined 20.2% in the moderate dose statin group and 26.6% in the intensive statin group, respectively (P<0.001). In a 2-year follow-up, a primary end point event occurred in 20 patients in the moderate dose statin group and in 28 patients in the intensive statin group. There was no significant between-group difference in the primary outcome (hazard ratio, 1.39; 95% confidence interval [CI], 0.78-2.46; P=0.245).
CONCLUSIONS


For ACS patients with a relatively low baseline LDL cholesterol level who received optimized current medication and interventional therapy, the incremental LDL cholesterol reduction of 6.4% achieved by double-dose statin did not bring significant clinical effectiveness.",2014,"There was no significant between-group difference in the primary outcome (hazard ratio, 1.39; 95% confidence interval [CI], 0.78-2.46; P=0.245).
","['acute coronary syndrome (ACS) in a Chinese population with low baseline LDL cholesterol levels', 'patients with acute coronary syndrome in China', 'Patients (n=1355) with ACS']","['intensive lipid-lowering therapy with statins', 'statin (atorvastatin 10 mg/d, or equivalent dose of other statins, n=675) or with an intensive dose of statin (atorvastatin, 20 or 40 mg/d, or equivalent dose of other statins', 'moderate-dose versus double-dose statins']","['incremental LDL cholesterol reduction', 'Baseline lipid levels', 'cardiac death, non-fatal acute myocardial infarction (MI), revascularization, ischemic stroke and documented unstable angina or severe heart failure requiring emergency hospitalization', 'LDL cholesterol levels', 'mean LDL cholesterol level']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1379772', 'cui_str': 'atorvastatin 10 MG'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",1355.0,0.235188,"There was no significant between-group difference in the primary outcome (hazard ratio, 1.39; 95% confidence interval [CI], 0.78-2.46; P=0.245).
","[{'ForeName': 'Shui-Ping', 'Initials': 'SP', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, PR China. Electronic address: zhaosp@medmail.com.cn.'}, {'ForeName': 'Bi-Lian', 'Initials': 'BL', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, PR China.'}, {'ForeName': 'Dao-Quan', 'Initials': 'DQ', 'LastName': 'Peng', 'Affiliation': 'Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, PR China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, PR China. Electronic address: huoyong@263.net.cn.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2013.12.003']
2348,24924874,Modifying the risk associated with an impulsive temperament: a prospective study of drug dependence treatment.,"The evidence linking the personality trait of impulsivity and substance misuse is well established. Importantly, impulsivity not only predicts substance misuse problems but has an association with duration in treatment, likelihood of completing treatment and time to relapse. Treatment that focuses on increasing awareness and acceptance of thoughts and emotions may potentially address impulsive behaviour and in this respect improve treatment outcomes for substance misuse. The current paper investigated the relationship between the facet of impulsivity that taps into poor inhibitory control and treatment outcome. In addition, there was a specific focus on ascertaining the impact of an increase in awareness and attentional control measured in 144 adult substance users receiving treatment in a residential therapeutic community. Impulsivity predicted poorer treatment outcome (measured as drug use severity). Increases in awareness and acceptance of emotions and thoughts during treatment were related to better outcome although this was not associated with baseline levels of impulsivity. Clinical and theoretical implications are discussed.",2014,Increases in awareness and acceptance of emotions and thoughts during treatment were related to better outcome although this was not associated with baseline levels of impulsivity.,['144 adult substance users receiving treatment in a residential therapeutic community'],[],"['awareness and acceptance of emotions and thoughts', 'awareness and attentional control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0338666', 'cui_str': 'Drug Users'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0039786', 'cui_str': 'Therapeutic Community'}]",[],"[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",144.0,0.0168945,Increases in awareness and acceptance of emotions and thoughts during treatment were related to better outcome although this was not associated with baseline levels of impulsivity.,"[{'ForeName': 'Petra K', 'Initials': 'PK', 'LastName': 'Staiger', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia. Electronic address: petra.staiger@deakin.edu.au.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Dawe', 'Affiliation': 'Australian Centre for Child Protection, University of South Australia, Adelaide; School of Applied Psychology, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hall', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia; Turning Point Centre, Melbourne, Australia.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Kambouropoulos', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia.'}]",Addictive behaviors,['10.1016/j.addbeh.2014.05.001']
2349,24528807,Impact of lipid-based nutrient supplements and corn-soy blend on energy and nutrient intake among moderately underweight 8-18-month-old children participating in a clinical trial.,"Nutrition interventions have an effect on growth, energy and nutrient intake, and development, but there are mixed reports on the effect of supplementation of energy-dense foods on dietary intake. This substudy aimed at assessing the effect of supplementation with corn-soy blend (CSB) or lipid-based nutrient supplement (LNS) on energy and nutrient intake in moderately underweight children participating in a clinical trial. A total of 188 children aged 8-18 months participated and received daily either 284 kcal from CSB or 220 kcal from LNS and no supplements (control). An interactive 24-h recall method was used to estimate energy and nutrient intakes in the groups. Total mean energy intake was 548 kcal, 551 kcal and 692 kcal in the control, CSB and LNS groups, respectively (P = 0.011). The mean (95% confidence interval) intake of energy and protein were 144 (37-250; P < 0.001) and 46 (1.5-7.6; P < 0.001) larger, respectively, in the LNS group than among the controls. No significant differences were observed between the control and CSB groups. Energy intake from non-supplement foods was significantly lower in the CSB group compared with the control group, but not in the LNS group, suggesting a lower displacement of non-supplement foods with LNS. Both CSB and LNS supplementation resulted in higher intakes of calcium, iron, zinc and vitamin C compared with controls (all P ≤ 0.001). This study indicates that LNS might be superior to CSB to supplement underweight children as it results in higher energy intake, but this requires confirmation in other settings.",2015,"Both CSB and LNS supplementation resulted in higher intakes of calcium, iron, zinc and vitamin C compared with controls (all P ≤ 0.001).","['moderately underweight children participating in a clinical trial', 'moderately underweight 8-18-month-old children participating in a clinical trial', '188 children aged 8-18 months participated and received']","['lipid-based nutrient supplements and corn-soy blend', 'Nutrition interventions', 'LNS', 'CSB and LNS supplementation', 'supplementation with corn-soy blend (CSB) or lipid-based nutrient supplement (LNS', 'daily either 284\u2009kcal from CSB or 220\u2009kcal from LNS and no supplements (control']","['higher intakes of calcium, iron, zinc and vitamin C', 'Energy intake', 'Total mean energy intake', 'energy and nutrient intake']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",188.0,0.0768501,"Both CSB and LNS supplementation resulted in higher intakes of calcium, iron, zinc and vitamin C compared with controls (all P ≤ 0.001).","[{'ForeName': 'Chrissie M', 'Initials': 'CM', 'LastName': 'Thakwalakwa', 'Affiliation': 'Department of International Health, University of Tampere School of Medicine, Tampere, Finland.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Department of International Health, University of Tampere School of Medicine, Tampere, Finland.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Phuka', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Yin Bun', 'Initials': 'YB', 'LastName': 'Cheung', 'Affiliation': 'Centre for Quantitative Medicine, Duke-NUS Graduate Medical School, Singapore.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Briend', 'Affiliation': 'Department of International Health, University of Tampere School of Medicine, Tampere, Finland.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Maleta', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Blantyre, Malawi.'}]",Maternal & child nutrition,['10.1111/mcn.12105']
2350,24978160,Who Signs Up for and Engages in a Peer Support Heart Failure Self-management Intervention.,"BACKGROUND


Many programs for patients with heart failure (HF) fail to improve clinical outcomes in part because of low rates of patient enrollment and engagement. A better understanding of patient characteristics associated with willingness to enroll and then engage in HF self-management programs will improve the design and targeting of programs.
METHODS AND RESULTS


Analyses of screening, baseline, and engagement data from a randomized controlled effectiveness trial of an HF peer self-management support program were conducted. The median age of the 266 recently hospitalized HF patients who enrolled in the study was 69 years, 51% were female, and 26% were minorities (primarily African American). Of 135 randomized to the peer support intervention, only 39% engaged in either the group sessions or telephone peer support calls. Older white women who reported higher baseline health status, functioning, social support, and confidence in their ability to manage and less difficulty with the physical and emotional aspects of living with HF were the most likely to engage in program activities. Minority status and reporting a need for social support were both correlated with higher enrollment but lower engagement in the intervention.
CONCLUSIONS


Although minority patients with poorer reported health status and social support were most likely to consent to participate in the study, participants who engaged in program activities were more likely to have higher baseline health status, functioning, and social support. Developing HF interventions that successfully engage participants most in need of HF self-management support remains a difficult challenge.",2015,"Of 135 randomized to the peer support intervention, only 39% engaged in either the group sessions or telephone peer support calls.","['Older white women', 'The median age of the 266 recently hospitalized HF patients who enrolled in the study was 69 years, 51% were female, and 26% were minorities (primarily African American', 'patients with heart failure (HF']","['peer support intervention', 'HF peer self-management support program', 'telephone peer support calls']",[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",[],266.0,0.0295775,"Of 135 randomized to the peer support intervention, only 39% engaged in either the group sessions or telephone peer support calls.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Mase', 'Affiliation': ""Rebecca Mase, MSW Clinical Research Project Manager, University of Michigan Medical School, Ann Arbor, and Center for Clinical Management Research, Ann Arbor Veterans' Affairs (VA) Healthcare System, Michigan. Lakshmi Halasyamani, MD Chief Medical Officer, Saint Joseph Mercy Health System, Ann Arbor, Michigan. Hwajung Choi, PhD Research Investigator, Department of Internal Medicine, University of Michigan, Ann Arbor. Michele Heisler, MD, MPA Professor and Research Scientist, University of Michigan Medical School, Ann Arbor, and Center for Clinical Management Research, Ann Arbor Veterans' Affairs (VA) Healthcare System, Michigan.""}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Halasyamani', 'Affiliation': ''}, {'ForeName': 'Hwajung', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000172']
2351,32426404,Tibial Tubercle-Roman Arch Distance: A New Measurement of Patellar Dislocation and Indication of Tibial Tubercle Osteotomy.,"Background


The surgical indication for tibial tubercle osteotomy (TTO) has been based on a tibial tubercle-trochlear groove (TT-TG) distance of 20 mm or greater in patients with patellar dislocation. However, the measurement of this parameter is less reliable in patients with trochlear dysplasia.
Hypothesis


The novel measurement of tibial tubercle-Roman arch (TT-RA) distance would be a reliable parameter for identifying the relative position of the tibial tubercle in patients with patellar dislocation, especially those with trochlear dysplasia.
Study Design


Cohort study (diagnosis); Level of evidence, 2.
Methods


A total of 56 patients with a diagnosis of patellar dislocation and 60 volunteers (60 knee joints) without a history of lower extremity pain or injury were included in our study. The TT-RA distance, TT-TG distance, and some femoral anatomic parameters were assessed by use of computed tomography. The measurements were performed by a radiologist and an orthopaedic surgeon in a blinded and randomized fashion. The difference in each parameter between the study and control groups was analyzed through use of an unpaired  t  test. Receiver operating characteristic curve analysis was performed to evaluate the discriminatory capacity of the included parameters. The cutoff values of the included measurements with specificity and sensitivity were calculated. In addition, the TT-TG distance and TT-RA distance were analyzed using the Dejour classification to evaluate the intraclass correlation coefficient (ICC) of each parameter in different types of femoral trochlea.
Result


A significant difference for TT-RA distance was found between the study group (23.24 ± 4.41 mm) and control group (19.15 ± 4.24 mm) ( P  < .001). The TT-RA distance had an area under the curve of 0.757. At a value greater than 23.74 mm, TT-RA distance had 53.57% sensitivity and 88.33% specificity for patellar dislocation. The ICCs of TT-RA distance measurements were excellent in all Dejour classifications (>0.939), whereas the ICCs of TT-TG distance measurements were relatively lower than the ICCs of TT-RA distance measurements. According to the data from included healthy individuals, the pathological TT-RA distance threshold was 26 mm.
Conclusion


Compared with TT-TG distance, the TT-RA distance is a more reliable parameter for identifying the relative position of the tibial tubercle in patients with trochlear dysplasia. For patients with a TT-RA distance greater than 26 mm, surgery should be considered to correct the malposition of the tibial tubercle.",2020,A significant difference for TT-RA distance was found between the study group (23.24 ± 4.41 mm) and control group (19.15 ± 4.24 mm) ( P  < .001).,"['patients with patellar dislocation', 'patients with trochlear dysplasia', 'patients with patellar dislocation, especially those with trochlear dysplasia', '56 patients with a diagnosis of patellar dislocation and 60 volunteers (60 knee joints) without a history of lower extremity pain or injury were included in our study']","['Tibial Tubercle Osteotomy', 'tibial tubercle osteotomy (TTO', 'Tibial Tubercle-Roman Arch Distance', 'tibial tubercle-Roman arch (TT-RA) distance']","['TT-RA distance, TT-TG distance, and some femoral anatomic parameters', 'ICCs of TT-RA distance measurements', 'TT-TG distance and TT-RA distance', 'ICCs of TT-TG distance measurements', 'TT-RA distance', 'pathological TT-RA distance threshold']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1135812', 'cui_str': 'Dislocation of patellofemoral joint'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0239376', 'cui_str': 'Pain of lower extremities'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0223896', 'cui_str': 'Structure of tibial tuberosity'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0816699', 'cui_str': 'Ulnar Trochlear Groove'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",56.0,0.0753838,A significant difference for TT-RA distance was found between the study group (23.24 ± 4.41 mm) and control group (19.15 ± 4.24 mm) ( P  < .001).,"[{'ForeName': 'Zijie', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Binjie', 'Initials': 'B', 'LastName': 'Fu', 'Affiliation': 'Department of Radiology, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Sheikh Ibrahimrashid', 'Initials': 'SI', 'LastName': 'Mohamed', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Aiguo', 'Initials': 'A', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967120914872']
2352,25040706,Barriers to weight-related health behaviours: a qualitative comparison of the socioecological conditions between pregnant and post-partum low-income women.,"The association between socioecological factors and poor health outcomes for low-income women and their children has been the focus of disparities research for several decades. This research compares the socioecological conditions among low-income women from pregnancy to post-partum and highlights the factors that make weight management increasingly difficult after delivery. As part of the formative research for an online health intervention, group and individual interviews were conducted with low-income pregnant and post-partum women. Five pregnancy group interviews (n = 15 women), five post-partum group interviews (n = 23 women) and seven individual interviews with a total of 45 participants were conducted in Rochester, New York. All interviews were audio-recorded. The constant comparative method was used to code interview notes and identify emergent themes. Subjects faced many challenges that affected their attitudes, beliefs and their ability to maintain or improve healthy weight behaviours. These included unemployment, relationship issues, minimal social support, lack of education, limited health care access, pre-existing medical conditions and neighbourhood disadvantage. Compared with pregnant women, post-partum women faced additional difficulties, such as child illnesses and custody issues. The most striking differences between pregnancy and post-partum related to the family's medical problems and greater environmental constraints. Many factors detracted from women's capacity to engage in healthy weight behaviours post-partum, including challenges present prior to delivery, challenges present prior to delivery that worsen after delivery, and new challenges that begin after delivery. These additional post-partum challenges need to be considered in designing programmes, policies and interventions that promote healthy weight.",2016,The most striking differences between pregnancy and post-partum related to the family's medical problems and greater environmental constraints.,"['pregnant and post-partum low-income women', 'Five pregnancy group interviews (n\u2009=\u200915 women), five post-partum group interviews (n\u2009=\u200923 women) and seven individual interviews with a total of 45 participants were conducted in Rochester, New York', 'low-income women and their children']",[],['healthy weight behaviours'],"[{'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0018260', 'cui_str': 'Group Interviews'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",45.0,0.0214825,The most striking differences between pregnancy and post-partum related to the family's medical problems and greater environmental constraints.,"[{'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Keriann', 'Initials': 'K', 'LastName': 'Uesugi', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Olson', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12135']
2353,32000724,Treatment intensification with hepatic arterial infusion chemotherapy in patients with liver-only colorectal metastases still unresectable after systemic induction chemotherapy - a randomized phase II study -- SULTAN UCGI 30/PRODIGE 53 (NCT03164655)- study protocol.,"BACKGROUND


Approximately 40% of colorectal cancer patients will develop colorectal liver metastases (CRLM). The most effective approach to increase long-term survival is CRLM complete resection. Unfortunately, only 10-15% of CRLM are initially considered resectable. The objective response rates (ORR) after current first-line systemic chemotherapy (sys-CT) regimens range from 40 to 80% and complete resection rates (CRR) range from 25 to 50% in patients with initially unresectable CRLM. When CRLM patients are not amenable to complete resection after induction of sys-CT, ORRs obtained with second-line sys-CT are much lower (between 10 and 30%) and consequently CRRs are also low (< 10%). Hepatic arterial infusion (HAI) oxaliplatin may represent a salvage therapy in patients with CRLM unresectable after one or more sys-CT regimens with ORRs and CRRs up to 60 and 30%, respectively. This study is designed to evaluate the efficacy of an intensification strategy based on HAI oxaliplatin combined with sys-CT as a salvage treatment in patients with CRLM unresectable after at least 2 months of first-line induction sys-CT.
OBJECTIVES AND ENDPOINTS OF THE PHASE II STUDY


Our main objective is to investigate the efficacy, in term of CRR (R0-R1), of treatment intensification in patients with liver-only CRLM not amenable to curative-intent resection (and/or ablation) after at least 2 months of induction sys-CT. Patients will receive either HAI oxaliplatin plus systemic FOLFIRI plus targeted therapy (i.e. anti-EGFR antibody or bevacizumab) or conventional sys-CT plus targeted therapy (i.e. anti-EGFR or antiangiogenic antibody). Secondary objectives are to compare: progression-free survival, overall survival, objective response rate, depth of response, feasibility of delivering HAI oxaliplatin including HAI catheter-related complications, and toxicity (NCI-CTCAE v4.0).
METHODS


This study is a multicenter, randomized, comparative phase II trial (power, 80%; two-sided alpha-risk, 5%). Patients will be randomly assigned in a 1:1 ratio to receive HAI oxaliplatin combined with systemic FOLFIRI plus targeted therapy (experimental arm) or the best sys-CT plus targeted therapy on the basis of their first-line prior sys-CT history and current guidelines (control arm). One hundred forty patients are required to account for non-evaluable patients.
TRIAL REGISTRATION


ClinicalTrials.gov, (NCT03164655). Trial registration date: 11th May 2017.",2020,"Our main objective is to investigate the efficacy, in term of CRR (R0-R1), of treatment intensification in patients with liver-only CRLM not amenable to curative-intent resection (and/or ablation) after at least 2 months of induction sys-CT.","['One hundred forty patients are required to account for non-evaluable patients', 'patients with CRLM unresectable after at least 2 months of first-line induction sys-CT', 'colorectal cancer patients will develop colorectal liver metastases (CRLM', 'patients with liver-only colorectal metastases still unresectable after systemic induction chemotherapy - a randomized phase II study -- SULTAN UCGI 30/PRODIGE 53 (NCT03164655)- study protocol', 'patients with liver-only CRLM not amenable to curative-intent resection (and/or ablation) after at least 2 months of induction sys-CT', 'patients with CRLM unresectable after one or more sys-CT regimens with ORRs and CRRs up to 60 and 30%, respectively']","['HAI oxaliplatin combined with sys-CT', 'current first-line systemic chemotherapy (sys-CT', 'hepatic arterial infusion chemotherapy', 'HAI oxaliplatin combined with systemic FOLFIRI plus targeted therapy (experimental arm) or the best sys-CT plus targeted therapy on the basis of their first-line prior sys-CT history and current guidelines (control arm', 'HAI oxaliplatin plus systemic FOLFIRI plus targeted therapy (i.e. anti-EGFR antibody or bevacizumab) or conventional sys-CT plus targeted therapy (i.e. anti-EGFR or antiangiogenic antibody', 'Hepatic arterial infusion (HAI) oxaliplatin']","['complete resection rates (CRR) range', 'objective response rates (ORR', 'progression-free survival, overall survival, objective response rate, depth of response, feasibility of delivering HAI oxaliplatin including HAI catheter-related complications, and toxicity (NCI-CTCAE v4.0']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0647895', 'cui_str': 'Sultan'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4304118', 'cui_str': 'Hepatic arterial infusion chemotherapy (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}]",,0.0542615,"Our main objective is to investigate the efficacy, in term of CRR (R0-R1), of treatment intensification in patients with liver-only CRLM not amenable to curative-intent resection (and/or ablation) after at least 2 months of induction sys-CT.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Boilève', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, 114 rue Edouard Vaillant, 94805, Villejuif Cedex, France. alice.boileve@gmail.com.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Maillard', 'Affiliation': 'Department of statistics and epidemiology, Villejuif, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'Department of radiology, CHU Pitié Salpétrière, Paris, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dromain', 'Affiliation': 'Department of radiology, Centre Hospitalier et Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Laurent', 'Affiliation': 'Department of hepatogastroenterology, Hôpital Haut Levêque, Pessac, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Dupont Bierre', 'Affiliation': 'Department of digestive surgery, CHP Saint Grégoire, Saint-Grégoire, France.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Le Sourd', 'Affiliation': 'Department of medical oncology, Centre Eugène-Marquis, Rennes, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Audemar', 'Affiliation': 'Department of hepatogastroenterology, Centre hospitalier Côte Basque, Bayonne, France.'}, {'ForeName': 'Ayhan', 'Initials': 'A', 'LastName': 'Ulusakarya', 'Affiliation': 'Department of medical oncology, Hôpital Paul Brousse, Villejuif, France.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Guerin-Meyer', 'Affiliation': ""Department of medical oncology, Institut de Cancerologie de l'Ouest, Angers, France.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Smisth', 'Affiliation': 'Department of hepatogastroenterology, Hôpital Haut Levêque, Pessac, France.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Pezzella', 'Affiliation': 'R&D Unicancer, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'De Baere', 'Affiliation': 'Department of interventional radiology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Goere', 'Affiliation': 'Department of Surgical Oncology, Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'Maximiliano', 'Initials': 'M', 'LastName': 'Gelli', 'Affiliation': 'Department of Surgical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Department of digestive oncology, Hôpital Européen Georges-Pompidou, Sorbonne Paris Cite/Paris Descartes University, Paris, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Boige', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, 114 rue Edouard Vaillant, 94805, Villejuif Cedex, France.'}]",BMC cancer,['10.1186/s12885-020-6571-7']
2354,24530788,The non-alcoholic fraction of beer increases stromal cell derived factor 1 and the number of circulating endothelial progenitor cells in high cardiovascular risk subjects: a randomized clinical trial.,"RATIONALE


Moderate alcohol consumption is associated with a decrease in cardiovascular risk, but fermented beverages seem to confer greater cardiovascular protection due to their polyphenolic content. Circulating endothelial progenitor cells (EPC) are bone-marrow-derived stem cells with the ability to repair and maintain endothelial integrity and function and are considered as a surrogate marker of vascular function and cumulative cardiovascular risk. Nevertheless, no study has been carried out on the effects of moderate beer consumption on the number of circulating EPC in high cardiovascular risk patients.
OBJECTIVE


To compare the effects of moderate consumption of beer, non-alcoholic beer and gin on the number of circulating EPC and EPC-mobilizing factors.
METHODS


In this crossover trial, 33 men at high cardiovascular risk were randomized to receive beer (30 g alcohol/d), the equivalent amount of polyphenols in the form of non-alcoholic beer, or gin (30 g alcohol/d) for 4 weeks. Diet and physical exercise were carefully monitored.
RESULTS


The number of circulating EPC and EPC-mobilizing factors were determined at baseline and after each intervention. After the beer and non-alcoholic beer interventions, the number of circulating EPC significantly increased by 8 and 5 units, respectively, while no significant differences were observed after the gin period. In correlation, stromal cell derived factor 1 increased significantly after the non-alcoholic and the beer interventions.
CONCLUSIONS


The non-alcoholic fraction of beer increases the number of circulating EPC in peripheral blood from high cardiovascular risk subjects.
CLINICAL TRIAL REGISTRATION


http://www.controlled-trials.com/ISRCTN95345245 ISRCTN95345245.",2014,"After the beer and non-alcoholic beer interventions, the number of circulating EPC significantly increased by 8 and 5 units, respectively, while no significant differences were observed after the gin period.","['high cardiovascular risk subjects', '33 men at high cardiovascular risk']",['Diet and physical exercise'],"['number of circulating EPC and EPC-mobilizing factors', 'Circulating endothelial progenitor cells (EPC', 'number of circulating EPC']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0169014', 'cui_str': 'erucylphosphocholine'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}]",33.0,0.0642417,"After the beer and non-alcoholic beer interventions, the number of circulating EPC significantly increased by 8 and 5 units, respectively, while no significant differences were observed after the gin period.","[{'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Chiva-Blanch', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Villarroel 170, 08036 Barcelona, Spain; CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBERobn) and RETIC RD06/0045, Spain.""}, {'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'Condines', 'Affiliation': ""Primary Care Research Group, IDIBAPS, Centre d'Assistència Primària ABS Les Corts (AS), GESCLINIC, Barcelona, Spain.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Magraner', 'Affiliation': ""Primary Care Research Group, IDIBAPS, Centre d'Assistència Primària ABS Les Corts (AS), GESCLINIC, Barcelona, Spain.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Roth', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Villarroel 170, 08036 Barcelona, Spain; CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBERobn) and RETIC RD06/0045, Spain.""}, {'ForeName': 'Palmira', 'Initials': 'P', 'LastName': 'Valderas-Martínez', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Villarroel 170, 08036 Barcelona, Spain; CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBERobn) and RETIC RD06/0045, Spain.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Arranz', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Villarroel 170, 08036 Barcelona, Spain; CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBERobn) and RETIC RD06/0045, Spain.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Casas', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Villarroel 170, 08036 Barcelona, Spain; CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBERobn) and RETIC RD06/0045, Spain.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Martínez-Huélamo', 'Affiliation': 'CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBERobn) and RETIC RD06/0045, Spain; Nutrition and Food Science Department, XaRTA, INSA, Faculty of Pharmacy, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vallverdú-Queralt', 'Affiliation': 'CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBERobn) and RETIC RD06/0045, Spain; Nutrition and Food Science Department, XaRTA, INSA, Faculty of Pharmacy, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Quifer-Rada', 'Affiliation': 'CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBERobn) and RETIC RD06/0045, Spain; Nutrition and Food Science Department, XaRTA, INSA, Faculty of Pharmacy, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Lamuela-Raventos', 'Affiliation': 'CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBERobn) and RETIC RD06/0045, Spain; Nutrition and Food Science Department, XaRTA, INSA, Faculty of Pharmacy, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': ""Department of Internal Medicine, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Villarroel 170, 08036 Barcelona, Spain; CIBER CB06/03 Fisiopatología de la Obesidad y la Nutrición, (CIBERobn) and RETIC RD06/0045, Spain. Electronic address: restruch@clinic.ub.es.""}]",Atherosclerosis,['10.1016/j.atherosclerosis.2013.12.048']
2355,25059838,Antenatal micronutrient supplementation and third trimester cortisol and erythropoietin concentrations.,"Antenatal iron and multiple micronutrient supplementation has been shown in randomized trials to improve birthweight, although mechanisms are unknown. We examined late pregnancy serum erythropoietin (EPO) and cortisol concentrations in relation to maternal micronutrient supplementation and iron status indicators (haemoglobin, serum ferritin, soluble transferrin receptor) in 737 rural Nepalese women to explore evidence of stress or anaemia-associated hypoxia. A double-masked randomized control trial was conducted from December 1998 to April 2001 in Sarlahi, Nepal, in which women received vitamin A alone (as control), or with folic acid (FA), FA + iron, FA + iron + zinc and a multiple micronutrient supplement. In a substudy, we collected maternal blood in the first and third trimester for biochemical assessments. Generalized estimating equations linear regression analysis was used to examine treatment group differences. EPO was ∼ 14-17 mIU mL(-1) lower (P < 0.0001) in late pregnancy in groups receiving iron vs. the control group, with no difference in the FA-only group. Cortisol was 1.3 μg dL(-1) lower (P = 0.04) only in the micronutrient supplement group compared with the control group. EPO was most strongly associated with iron status indicators in groups that did not receive iron, and in the non-iron groups cortisol was positively correlated with EPO (r = 0.15, P < 0.01) and soluble transferrin receptor (sTfR, r = 0.19, P < 0.001). In adjusted analyses, third trimester EPO was associated with a reduction in low birthweight, whereas cortisol was negatively associated with length of gestation and higher risk of preterm birth. Iron and multiple micronutrient supplementation may enhance birth outcomes by reducing mediators of maternal stress and impaired erythropoiesis.",2016,"EPO was most strongly associated with iron status indicators in groups that did not receive iron, and in the non-iron groups cortisol was positively correlated with EPO (r = 0.15, P < 0.01) and soluble transferrin receptor (sTfR, r = 0.19, P < 0.001).","['737 rural Nepalese women to explore evidence of stress or anaemia-associated hypoxia', 'December 1998 to April 2001 in Sarlahi, Nepal, in which women received']","['vitamin A alone (as control), or with folic acid (FA), FA + iron, FA + iron + zinc and a multiple micronutrient supplement', 'Antenatal iron and multiple micronutrient supplementation', 'Iron and multiple micronutrient supplementation']","['maternal stress and impaired erythropoiesis', 'length of gestation and higher risk of preterm birth', 'late pregnancy serum erythropoietin (EPO) and cortisol concentrations', 'soluble transferrin receptor', 'EPO']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}]","[{'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0014819', 'cui_str': 'Erythropoiesis'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble (substance)'}]",,0.0794532,"EPO was most strongly associated with iron status indicators in groups that did not receive iron, and in the non-iron groups cortisol was positively correlated with EPO (r = 0.15, P < 0.01) and soluble transferrin receptor (sTfR, r = 0.19, P < 0.001).","[{'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Christian', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Ashika', 'Initials': 'A', 'LastName': 'Nanayakkara-Bind', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Schulze', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'LeClerq', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'The Nepal Nutrition Intervention Project-Sarlahi, Kathmandu, Nepal.'}]",Maternal & child nutrition,['10.1111/mcn.12138']
2356,24995700,Supplemental iron intake and the risk of glucose intolerance in pregnancy: re-analysis of a randomised controlled trial in Finland.,"Observational studies suggest that high iron intake during pregnancy is associated with the risk of gestational diabetes. As such studies are prone to bias, we re-analysed data from a randomised controlled trial of iron supplementation to see whether it supports the risk found in observational studies. The trial was conducted in primary health care setting in five municipalities in Finland in 1985-1986. The participants were 2944 women (95% of pregnant women in the area) who were randomly allocated either to (1) the selective iron group (elemental iron 50 mg twice a day only if diagnosed as anaemic, continuing until their haemoglobin increased to 110 g L(-1)) or (2) the routine iron group (elemental iron 100 mg day(-1) throughout the pregnancy regardless of haemoglobin level). The numbers of women in the analyses were 1358 and 1336, respectively. The main outcome measure was a composite variable including any glucose intolerance-related outcome (e.g. glucosuria, gestational diabetes, large-for-gestational-age child) in mothers' or children's patient records during pregnancy and post-partum. There were no statistically significant differences in the incidence of the primary outcome between the selective iron and the routine iron groups (13.0 vs. 11.0%, P = 0.12). The most common outcome was large-for-gestational-age calculated from children's hospital data (8.3 vs. 8.2%, P = 0.95). The results were mainly similar when stratified by the mothers' baseline haemoglobin level, body mass index or gestational weight gain. Routine iron supplementation throughout pregnancy did not increase the risk of glucose intolerance during pregnancy. The results need to be confirmed in future trials.",2016,"There were no statistically significant differences in the incidence of the primary outcome between the selective iron and the routine iron groups (13.0 vs. 11.0%, P = 0.12).","['pregnancy', 'primary health care setting in five municipalities in Finland in 1985-1986', 'participants were 2944 women (95% of pregnant women in the area']","['Routine iron supplementation', 'selective iron group (elemental iron 50 mg twice a day only if diagnosed as anaemic, continuing until their haemoglobin increased to 110 g L(-1)) or (2) the routine iron group (elemental iron 100 mg day(-1) throughout the pregnancy regardless of haemoglobin level', 'Supplemental iron intake']","['baseline haemoglobin level, body mass index or gestational weight gain', ""composite variable including any glucose intolerance-related outcome (e.g. glucosuria, gestational diabetes, large-for-gestational-age child) in mothers' or children's patient records during pregnancy and post-partum"", 'risk of glucose intolerance', ""large-for-gestational-age calculated from children's hospital data""]","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0600182'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4547015', 'cui_str': '50Fe radioisotope'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0549448', 'cui_str': 'Increased hemoglobin (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0518043', 'cui_str': 'Iron intake (observable entity)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C1848395', 'cui_str': 'Large for gestational age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}]",2944.0,0.327886,"There were no statistically significant differences in the incidence of the primary outcome between the selective iron and the routine iron groups (13.0 vs. 11.0%, P = 0.12).","[{'ForeName': 'Tarja I', 'Initials': 'TI', 'LastName': 'Kinnunen', 'Affiliation': 'School of Health Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Luoto', 'Affiliation': 'The UKK Institute for Health Promotion Research, Tampere, Finland.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Helin', 'Affiliation': 'School of Health Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Hemminki', 'Affiliation': 'Service System Department, The National Institute for Health and Welfare, Helsinki, Finland.'}]",Maternal & child nutrition,['10.1111/mcn.12139']
2357,31362145,The impact of uncontrollability beliefs and thought-related distress on ecological momentary interventions for generalized anxiety disorder: A moderated mediation model.,"This study was a secondary analysis of LaFreniere and Newman (2016), a randomized controlled trial comparing two ecological momentary interventions (EMIs) for generalized anxiety disorder (GAD): The worry outcome journal (WOJ) and thought log (TL). We predicted that higher thought-related distress would be a mediator by which higher uncontrollability beliefs (UB) would hinder the efficacy of the WOJ, but not the TL. Fifty-one undergraduates who met GAD criteria underwent one of the EMIs for 10 days. WOJ users tracked worries, associated distress, interference, expected outcome probabilities, and whether their worries came true four times/day. TL users tracked general thoughts, associated distress, and interference four times/day. Bootstrapping path analysis was used to analyze moderated mediation models. Higher UB predicted higher thought-related distress for both EMIs. Higher UB also predicted reduced efficacy of the WOJ at post-trial and of both EMIs at 30-day follow-up. However, for WOJ users, when higher initial UB levels predicted higher thought-related distress early in treatment, participants reported greater levels of worry at post-trial and follow-up. In contrast, UB's effect on the TL group at post-trial and follow-up was not mediated by early distress. Thought-related distress appears to be a mechanism by which UB impedes the WOJ intervention.",2019,Higher UB also predicted reduced efficacy of the WOJ at post-trial and of both EMIs at 30-day follow-up.,"['Fifty-one undergraduates who met GAD criteria underwent one of the EMIs for 10 days', 'generalized anxiety disorder', 'generalized anxiety disorder (GAD', 'LaFreniere and Newman (2016']","['ecological momentary interventions', 'TL', 'ecological momentary interventions (EMIs']",['worry outcome journal (WOJ) and thought log (TL'],"[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}]",[],"[{'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}]",,0.078939,Higher UB also predicted reduced efficacy of the WOJ at post-trial and of both EMIs at 30-day follow-up.,"[{'ForeName': 'Lucas S', 'Initials': 'LS', 'LastName': 'LaFreniere', 'Affiliation': 'The Pennsylvania State University, United States. Electronic address: lsl141@psu.edu.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'The Pennsylvania State University, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102113']
2358,31343948,"""Beet"" the cold: beetroot juice supplementation improves peripheral blood flow, endothelial function, and anti-inflammatory status in individuals with Raynaud's phenomenon.","Raynaud's phenomenon (RP) is characterized by recurrent transient peripheral vasospasm and lower nitric oxide (NO) bioavailability in the cold. We investigated the effect of nitrate-rich beetroot juice (BJ) supplementation on  1 ) NO-mediated vasodilation,  2 ) cutaneous vascular conductance (CVC) and skin temperature (T sk ) following local cooling, and  3 ) systemic anti-inflammatory status. Following baseline testing, 23 individuals with RP attended four times, in a double-blind, randomized crossover design, following acute and chronic (14 days) BJ and nitrate-depleted beetroot juice (NDBJ) supplementation. Peripheral T sk  and CVC were measured during and after mild hand and foot cooling, and during transdermal delivery of acetylcholine and sodium nitroprusside. Markers of anti-inflammatory status were also measured. Plasma nitrite concentration ([nitrite]) was increased in the BJ conditions ( P  < 0.001). Compared with the baseline visit, thumb CVC was greater following chronic-BJ (Δ2.0 flux/mmHg,  P  = 0.02) and chronic-NDBJ (Δ1.45 flux/mmHg,  P  = 0.01) supplementation; however, no changes in T sk  were observed ( P  > 0.05). Plasma [interleukin-10] was greater, pan endothelin and systolic and diastolic blood pressure (BP) were reduced, and forearm endothelial function was improved, by both BJ and NDBJ supplementation ( P  < 0.05). Acute and chronic BJ and NDBJ supplementation improved anti-inflammatory status, endothelial function and blood pressure (BP). CVC following cooling increased post chronic-BJ and chronic-NDBJ supplementation, but no effect on T sk  was observed. The key findings are that beetroot supplementation improves thumb blood flow, improves endothelial function and anti-inflammatory status, and reduces BP in people with Raynaud's. NEW & NOTEWORTHY  This is the first study to examine the effect of dietary nitrate supplementation in individuals with Raynaud's phenomenon. The principal novel findings from this study were that both beetroot juice and nitrate-depleted beetroot juice  1 ) increased blood flow in the thumb following a cold challenge;  2 ) enhanced endothelium-dependent and -independent vasodilation in the forearm;  3 ) reduced systolic and diastolic blood pressure, and pan-endothelin concentration; and  4 ) improved inflammatory status in comparison to baseline.",2019,"Plasma [interleukin-10] was greater, pan endothelin and systolic and diastolic blood pressure (BP) were reduced, and forearm endothelial function was improved ,by both BR and NDBJ supplementation ( P  < 0.05).","[""individuals with Raynaud's phenomenon""]","['NDBJ supplementation', 'nitrate-depleted beetroot juice (NDBJ) supplementation', 'acetylcholine and sodium nitroprusside', 'nitrate-rich beetroot juice (BJ) supplementation']","['Plasma [interleukin-10', 'Peripheral T sk  and CVC', 'peripheral blood flow, endothelial function and anti-inflammatory status', 'nitric oxide (NO) bioavailability', 'chronic-NDBJ', 'pan endothelin and systolic and diastolic blood pressure (BP', 'anti-inflammatory status, endothelial function and BP', 'forearm endothelial function', 'Plasma [nitrite', 'T sk', 'i)  NO-mediated vasodilation,  ii)  cutaneous vascular conductance (CVC) and skin temperature (T sk ']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0034735', 'cui_str': 'Raynaud Phenomenon'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0037533', 'cui_str': 'Sodium Nitroprusside'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0425710', 'cui_str': 'Peripheral blood flow (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0079284', 'cui_str': 'Endothelium-Derived Vasoconstrictor Factors'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}]",23.0,0.1203,"Plasma [interleukin-10] was greater, pan endothelin and systolic and diastolic blood pressure (BP) were reduced, and forearm endothelial function was improved ,by both BR and NDBJ supplementation ( P  < 0.05).","[{'ForeName': 'Anthony I', 'Initials': 'AI', 'LastName': 'Shepherd', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Costello', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bailey', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Epinal Way, Loughborough, United Kingdom.'}, {'ForeName': 'Nicolette', 'Initials': 'N', 'LastName': 'Bishop', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Epinal Way, Loughborough, United Kingdom.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'Wadley', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Epinal Way, Loughborough, United Kingdom.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Young-Min', 'Affiliation': 'Rheumatology Department, Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gilchrist', 'Affiliation': 'University of Exeter Medical School and NIHR Exeter Clinical Research Facility, Royal Devon and Exeter Hospital, Exeter, Devon, United Kingdom.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Mayes', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gorczynski', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Zoe L', 'Initials': 'ZL', 'LastName': 'Saynor', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Massey', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Clare M', 'Initials': 'CM', 'LastName': 'Eglin', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00292.2019']
2359,32426949,Protein quality in ready-to-use supplementary foods for moderate wasting.,"There are no guidelines for the optimal protein quality of ready-to-supplementary food (RUSF) for moderate acute malnutrition (MAM). This randomized, controlled, double-blinded, clinical effectiveness trial evaluated two RUSFs in the treatment of MAM. Both foods contained greater than 7% dairy protein, but the protein-optimized RUSF had a calculated digestible indispensable amino acid score (DIAAS) of 95%, whereas the control RUSF had a calculated DIAAS of 63%. There were 1,737 rural Malawian children 6-59 months of age treated with 75 kcal/kg/day of either control or protein quality-optimized RUSF for up to 12 weeks. There was no difference in the proportion of children who recovered from MAM between the group that received protein-optimized RUSF (759/860, 88%) and the group that received control RUSF (766/877, 87%, difference 1%, 95% CI, -2.1 to 4.1, p = 0.61). There were no differences in time to recovery or average weight gain; nor were adverse effects reported. Both RUSFs showed indistinguishable clinical outcomes, with recovery rates higher than typically seen in treatment for MAM. The DIAAS of these two RUSFs was measured using a pig model. Unexpectedly, the protein quality of the optimized RUSF was inferior to the control RUSF: DIAAS = 82% for the protein quality optimized RUSF and 96% for control RUSF. The controlled conditions of this trial suggest that in supplementary food products for MAM, protein quality is not an independent predictor of clinical effectiveness.",2020,"There was no difference in the proportion of children who recovered from MAM between the group that received protein-optimized RUSF (759/860, 88%) and the group that received control RUSF (766/877, 87%, difference 1%, 95% CI, -2.1 to 4.1, p = 0.61).","['moderate wasting', '1,737 rural Malawian children 6-59 months of age treated with 75 kcal/kg/day of either control or protein quality-optimized RUSF for up to 12 weeks']","['control RUSF', 'RUSFs']","['Protein quality', 'proportion of children who recovered from MAM', 'time to recovery or average weight gain', 'calculated digestible indispensable amino acid score (DIAAS']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1690969', 'cui_str': 'Kcal/kg/day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1737.0,0.143598,"There was no difference in the proportion of children who recovered from MAM between the group that received protein-optimized RUSF (759/860, 88%) and the group that received control RUSF (766/877, 87%, difference 1%, 95% CI, -2.1 to 4.1, p = 0.61).","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Roediger', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Washington University, St. Louis, Missouri, USA.'}, {'ForeName': 'Hans-Henrik', 'Initials': 'HH', 'LastName': 'Stein', 'Affiliation': 'Department of Animal Science, University of Illinois, Urbana, Illinois, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Callaghan-Gillespie', 'Affiliation': 'Department of Pediatrics, Washington University, St. Louis, Missouri, USA.'}, {'ForeName': 'Jeffrey Kahn', 'Initials': 'JK', 'LastName': 'Blackman', 'Affiliation': 'Department of Pediatrics, Washington University, St. Louis, Missouri, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Kohlmann', 'Affiliation': 'Department of Pediatrics, Washington University, St. Louis, Missouri, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'Department of Community Health, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Manary', 'Affiliation': 'Department of Pediatrics, Washington University, St. Louis, Missouri, USA.'}]",Maternal & child nutrition,['10.1111/mcn.13019']
2360,24750689,Transformative Lifestyle Change: key to sustainable weight loss among women in a post-partum diet and exercise intervention.,"The increase in overweight and obesity among women is a growing concern, and reproduction is associated with persistent weight gain. We have shown that dietary behavioural modification treatment, with or without exercise, results in weight loss and maintenance of weight loss. The aim of this study was to provide an explanatory model of how overweight and obese women achieve weight loss during, and after, participating in a post-partum diet and/or exercise intervention. Using Grounded Theory, we performed and analysed 29 interviews with 21 women in a 12-week Swedish post-partum lifestyle intervention with a 9-month follow-up. Interviews were made after the intervention and at the 9-month follow-up. To overcome initial barriers to weight loss, the women needed a 'Catalytic Interaction' (CI) from the care provider. It depended on individualised, concrete, specific and useful information, and an emotional bond through joint commitment, trust and accountability. Weight loss was underpinned by gradual introduction of conventional health behaviours. However, the implementation depended on the experience of the core category process 'Transformative Lifestyle Change' (TLC). This developed through a transformative process of reciprocal changes in cognitions, emotions, body, environment, behaviours and perceived self. Women accomplishing the stages of the TLC process were successful in weight loss, in contrast to those who did not. The TLC process, dependent on initiation through CI, led to implementation and integration of recognised health behaviours, resulting in sustainable weight loss. The TLC model, including the CI construct and definition of barriers, facilitators and strategies provides an explanatory model of this process.",2015,"It depended on individualised, concrete, specific and useful information, and an emotional bond through joint commitment, trust and accountability.",['women in a post-partum diet and exercise intervention'],[],"['sustainable weight loss', 'weight loss and maintenance of weight loss', 'overweight and obesity', 'weight loss', 'Weight loss', 'cognitions, emotions, body, environment, behaviours and perceived self']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",29.0,0.0267202,"It depended on individualised, concrete, specific and useful information, and an emotional bond through joint commitment, trust and accountability.","[{'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Bertz', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Sparud-Lundin', 'Affiliation': 'Institute of Health and Care Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Winkvist', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, University of Gothenburg, Gothenburg, Sweden.'}]",Maternal & child nutrition,['10.1111/mcn.12103']
2361,24784325,Association between maternal depressive symptoms in the early post-natal period and responsiveness in feeding at child age 2 years.,"Maternal depression is a known risk factor for poor outcomes for children. Pathways to these poor outcomes relate to reduced maternal responsiveness or sensitivity to the child. Impaired responsiveness potentially impacts the feeding relationship and thus may be a risk factor for inappropriate feeding practices. The aim of this study was to examine the longitudinal relationships between self-reported maternal post-natal depressive symptoms at child age 4 months and feeding practices at child age 2 years in a community sample. Participants were Australian first-time mothers allocated to the control group of the NOURISH randomized controlled trial when infants were 4 months old. Complete data from 211 mothers (of 346 allocated) followed up when their children were 2 years of age (51% girls) were available for analysis. The relationship between Edinburgh Postnatal Depression Scale (EPDS) score (child age 4 months) and child feeding practices (child age 2 years) was tested using hierarchical linear regression analysis adjusted for maternal and child characteristics. Higher EPDS score was associated with less responsive feeding practices at child age 2 years: greater pressure [β = 0.18, 95% confidence interval (CI): 0.04-0.32, P = 0.01], restriction (β = 0.14, 95% CI: 0.001-0.28, P = 0.05), instrumental (β = 0.14, 95% CI: 0.005-0.27, P = 0.04) and emotional (β = 0.15, 95% CI: 0.01-0.29, P = 0.03) feeding practices (ΔR(2) values: 0.02-0.03, P < 0.05). This study provides evidence for the proposed link between maternal post-natal depressive symptoms and lower responsiveness in child feeding. These findings suggest that the provision of support to mothers experiencing some levels of depressive symptomatology in the early post-natal period may improve responsiveness in the child feeding relationship.",2015,"Higher EPDS score was associated with less responsive feeding practices at child age 2 years: greater pressure [β = 0.18, 95% confidence interval (CI): 0.04-0.32, P = 0.01], restriction (β = 0.14, 95% CI: 0.001-0.28, P = 0.05), instrumental (β = 0.14, 95% CI: 0.005-0.27, P = 0.04) and emotional (β = 0.15, 95% CI: 0.01-0.29, P = 0.03) feeding practices (ΔR(2) values: 0.02-0.03, P < 0.05).","['child feeding', 'children', 'longitudinal relationships between self-reported maternal post-natal depressive symptoms at child age 4 months and feeding practices at child age 2 years in a community sample', '211 mothers (of 346 allocated) followed up when their children were 2 years of age (51% girls']",[],"['Maternal depression', 'depressive symptomatology', 'Edinburgh Postnatal Depression Scale (EPDS) score', 'maternal depressive symptoms', 'Higher EPDS score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0454729', 'cui_str': 'Natal (geographic location)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0567465', 'cui_str': 'Feeding practice (regime/therapy)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score (observable entity)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.131754,"Higher EPDS score was associated with less responsive feeding practices at child age 2 years: greater pressure [β = 0.18, 95% confidence interval (CI): 0.04-0.32, P = 0.01], restriction (β = 0.14, 95% CI: 0.001-0.28, P = 0.05), instrumental (β = 0.14, 95% CI: 0.005-0.27, P = 0.04) and emotional (β = 0.15, 95% CI: 0.01-0.29, P = 0.03) feeding practices (ΔR(2) values: 0.02-0.03, P < 0.05).","[{'ForeName': 'Kimberley M', 'Initials': 'KM', 'LastName': 'Mallan', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Lynne A', 'Initials': 'LA', 'LastName': 'Daniels', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jacinda L', 'Initials': 'JL', 'LastName': 'Wilson', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Jansen', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Nicholson', 'Affiliation': 'Parenting Research Centre, Melbourne, Victoria, Australia.'}]",Maternal & child nutrition,['10.1111/mcn.12116']
2362,24784143,Bottle and sippy cup use is associated with diet and energy intake in toddlers.,"The second year of life incorporates a continued shift from a liquid- to solid-based diet. Little is known about the prevalence and dietary impact of bottle and sippy cup use. This paper describes associations between percent of energy consumed via drinking containers (bottles and sippy cups combined) and dietary outcomes, between 1 and 2 years of age. This observational study recruited n = 299 low-income, nutrition programme clients from the Bronx, NY, whose 12 month olds consumed ≥ 2 non-water bottles per day. The main exposure variable was percent of energy intake via drinking containers (PEDC), dichotomized at the median into low-percent-energy-from-drinking-containers (LOW-C) and high-percent-energy-from-drinking-containers (HIGH-C) groups, assessed quarterly, for 1 year. We report 24-hour dietary recall nutrient and food serving data by LOW-C vs. HIGH-C. We employed linear mixed models to study associations between PEDC and nutrient intake. PEDC decreased from 52% to 33% between 1 and 2 years of age in both groups. The LOW-C group had higher intake of energy, dietary fibre, iron and sodium, grains, protein-rich foods and sweets. Conversely, LOW-C group had lower intake of Vitamin D and calcium vs. the HIGH-C group. PEDC was inversely associated with total energy intake in a model controlling for baseline age, baseline-weight-for-length and gender (β = -5.8, P = 0.029, 95% confidence interval (-10.96, -0.6). Lower bottle and sippy cup use had significant, albeit mixed association with diet quality in the second year of life, and was associated with higher energy intake. Evidence-based guidelines are needed to determine the appropriate use of those feeding methods.",2015,"Lower bottle and sippy cup use had significant, albeit mixed association with diet quality in the second year of life, and was associated with higher energy intake.","['toddlers', 'n\u2009=\u2009299 low-income, nutrition programme clients from the Bronx, NY, whose 12 month olds consumed\u2009≥\u20092 non-water bottles per day']",['24-hour dietary recall nutrient and food serving data by LOW-C vs. HIGH-C'],"['PEDC', 'total energy intake', 'energy intake via drinking containers (PEDC', 'intake of Vitamin D', 'intake of energy, dietary fibre, iron and sodium, grains, protein-rich foods and sweets']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C0439505', 'cui_str': 'per day'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0180098', 'cui_str': 'Container (physical object)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0453861', 'cui_str': 'Rich food (substance)'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}]",299.0,0.040581,"Lower bottle and sippy cup use had significant, albeit mixed association with diet quality in the second year of life, and was associated with higher energy intake.","[{'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Ben-Avraham', 'Affiliation': 'Department of Family and Social Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Christel J', 'Initials': 'CJ', 'LastName': 'Hyden', 'Affiliation': 'Department of Family and Social Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fletcher', 'Affiliation': 'Department of Family and Social Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Bonuck', 'Affiliation': 'Department of Family and Social Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12114']
2363,24855155,Impact of intensive lifestyle intervention on depression and health-related quality of life in type 2 diabetes: the Look AHEAD Trial.,"OBJECTIVE


We examined the effects of an intensive lifestyle intervention (ILI), compared with a diabetes support and education (DSE) control intervention, on long-term changes in depression symptoms, antidepressant medication (ADM) use, and health-related quality of life (HRQoL) in overweight/obese individuals with type 2 diabetes.
RESEARCH DESIGN AND METHODS


Look AHEAD was a multisite randomized controlled trial of 5,145 overweight/obese participants assigned to ILI (designed to produce weight loss) or DSE and followed for a median of 9.6 years. The Beck Depression Inventory (BDI) was administered at baseline, annually at years 1-4, and again at year 8. Mean BDI scores and incidence of BDI scores ≥10, indicative of likely mild or greater depression, were examined. Annually through year 10, participants reported their ADM use and completed the Medical Outcomes Study Short Form 36 (SF-36) questionnaire, which yields physical component summary (PCS) and mental component summary (MCS) scores.
RESULTS


ILI significantly reduced the incidence of mild or greater depression symptoms (BDI scores ≥10) compared with DSE (hazard ratio [HR] = 0.85; 95% CI 0.75-0.97; P = 0.0145). Although SF-36 PCS scores worsened over time in both groups, ILI participants reported better physical function than DSE throughout the first 8 years (all P values <0.01). There were no significant differences between treatment arms in the proportion of participants who used ADMs or in SF-36 MCS scores.
CONCLUSIONS


ILI for overweight/obese patients with type 2 diabetes may reduce the risk of developing clinically significant symptoms of depression and preserve physical HRQoL. These findings should be considered when evaluating the potential benefits of ILIs.",2014,"There were no significant differences between treatment arms in the proportion of participants who used ADMs or in SF-36 MCS scores.
","['5,145 overweight/obese participants assigned to ILI (designed to produce weight loss) or DSE and followed for a median of 9.6 years', 'type 2 diabetes', 'overweight/obese individuals with type 2 diabetes']","['intensive lifestyle intervention (ILI', 'intensive lifestyle intervention', 'diabetes support and education (DSE) control intervention']","['incidence of mild or greater depression symptoms', 'proportion of participants who used ADMs or in SF-36 MCS scores', 'Beck Depression Inventory (BDI', 'SF-36 PCS scores', 'physical function', 'Mean BDI scores and incidence of BDI scores ≥10, indicative of likely mild or greater depression', 'depression symptoms, antidepressant medication (ADM) use, and health-related quality of life (HRQoL', 'Medical Outcomes Study Short Form 36 (SF-36) questionnaire, which yields physical component summary (PCS) and mental component summary (MCS) scores', 'depression and health-related quality of life']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",5145.0,0.081875,"There were no significant differences between treatment arms in the proportion of participants who used ADMs or in SF-36 MCS scores.
","[{'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Rubin', 'Affiliation': ''}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': ''}, {'ForeName': 'Judy L', 'Initials': 'JL', 'LastName': 'Bahnson', 'Affiliation': ''}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Blackburn', 'Affiliation': ''}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Brancati', 'Affiliation': ''}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': ''}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': ''}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': ''}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Curtis', 'Affiliation': ''}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Dutton', 'Affiliation': ''}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Egan', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ewing', 'Affiliation': ''}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Faulconbridge', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Foreyt', 'Affiliation': ''}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': ''}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Gregg', 'Affiliation': ''}, {'ForeName': 'Helen P', 'Initials': 'HP', 'LastName': 'Hazuda', 'Affiliation': ''}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': ''}, {'ForeName': 'Van S', 'Initials': 'VS', 'LastName': 'Hubbard', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': ''}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Jeffery', 'Affiliation': ''}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': ''}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lang', 'Affiliation': ''}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Montez', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Murillo', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nathan', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Patricio', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': ''}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Pownall', 'Affiliation': ''}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': ''}, {'ForeName': 'Renate H', 'Initials': 'RH', 'LastName': 'Rosenthal', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Ruelas', 'Affiliation': ''}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Toledo', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Van Dorsten', 'Affiliation': ''}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Vitolins', 'Affiliation': ''}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Williamson', 'Affiliation': ''}, {'ForeName': 'Rina R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': ''}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': ''}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc13-1928']
2364,24784976,Preventative lipid-based nutrient supplements (LNS) and young child feeding practices: findings from qualitative research in Haiti.,"To prevent undernutrition in an urban slum in Haiti, a lipid-based nutrient supplement (LNS) was introduced through a randomised control trial. Food supplementation for young child nutrition has a long history in Haiti, but there is little empirical information regarding the effects of supplementation on young child feeding practices. One of the concerns raised by supplementation is that it may disrupt other positive feeding practices such as breastfeeding and use of other complementary foods, with negative consequences for child nutrition. We conducted 29 in-depth interviews with mother-baby pairs from the three comparison groups: control, 3-month LNS supplementation and 6-month LNS supplementation. Findings from those in the LNS groups indicated high acceptance and satisfaction with LNS and perceptions that it positively affects child health and development. LNS was integrated into and enhanced ongoing complementary feeding practices. The effects of LNS use on duration and perceived quantity of breastfeeding were variable, but generally, breastfeeding was maintained during and after the intervention. Interviews generated insights into beliefs regarding infant and young child feeding practices such as introduction and use of complementary foods, and breastfeeding duration, exclusivity and cessation. Implications for the use of LNS in public health nutrition programmes are discussed.",2015,Findings from those in the LNS groups indicated high acceptance and satisfaction with LNS and perceptions that it positively affects child health and development.,"['29 in-depth interviews with mother-baby pairs from the three comparison groups', 'young child feeding practices']","['control, 3-month LNS supplementation and 6-month LNS supplementation', 'Food supplementation', 'lipid-based nutrient supplement (LNS', 'Preventative lipid-based nutrient supplements (LNS', 'LNS']",['duration and perceived quantity of breastfeeding'],"[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]",,0.0200134,Findings from those in the LNS groups indicated high acceptance and satisfaction with LNS and perceptions that it positively affects child health and development.,"[{'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Lesorogol', 'Affiliation': 'George Warren Brown School of Social Work, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Sherlie', 'Initials': 'S', 'LastName': 'Jean-Louis', 'Affiliation': 'Institute for Public Health/Brown School of Social Work, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Institute for Public Health/Brown School of Social Work, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Iannotti', 'Affiliation': 'Institute for Public Health/Brown School of Social Work, Washington University in St. Louis, St. Louis, Missouri, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12122']
2365,29734211,Early Versus Standard Colonoscopy: A Randomized Controlled Trial in Patients With Acute Lower Gastrointestinal Bleeding: Results of the BLEED Study.,"GOALS


The aim of our study was to examine differences in length of hospital stay (LOHS) between patients with lower gastrointestinal bleeding who received either an early colonoscopy (within 24 h of presentation) or a standard colonoscopy (within 1 to 3 d).
BACKGROUND


Diagnostic management of lower gastrointestinal bleeding has been extensively debated in recent literature, especially whether colonoscopy within 24 hours of presentation is feasible and safe.
STUDY


In this single center, nonblinded, randomized controlled trial, patients presenting at the emergency department with acute hematochezia were eligible if they required hospital admission. A total of 132 patients were included. Primary outcome was LOHS. Secondary outcomes included yield of colonoscopy, blood transfusion requirements, recurrent bleedings, complications, interventions related to complications, and 30-day mortality. The follow-up period was 1 month.
RESULTS


In total, 63 patients were randomized for <24 hours colonoscopy and 69 for standard colonoscopy. In the intention to treat analysis, LOHS was significantly lower in patients that underwent an early colonoscopy, compared with the standard group: median 2.0 days (inter quartile range, 2.0 to 4.0) versus median 3.0 days (inter quartile range, 2.0 to 4.0) (P=0.009). Recurrent bleedings and hospital readmissions were significantly more frequent in the <24-hour group: 13% versus 3% (P=0.04) and 11% versus 2% (P=0.02), respectively. No difference was observed regarding the number of patients diagnosed with a confirmed or presumptive bleeding source. In both groups, blood transfusion rate was similar and 30-day mortality was 0.
CONCLUSIONS


Early colonoscopy reduces LOHS, but also results in lower clinical efficacy compared with standard colonoscopy.",2019,"Recurrent bleedings and hospital readmissions were significantly more frequent in the <24-hour group: 13% versus 3% (P=0.04) and 11% versus 2% (P=0.02), respectively.","['Patients With Acute Lower Gastrointestinal Bleeding', 'patients with lower gastrointestinal bleeding who received either an early colonoscopy (within 24\u2009h of presentation) or a', '63 patients were randomized for <24 hours colonoscopy and 69 for standard colonoscopy', 'patients presenting at the emergency department with acute hematochezia were eligible if they required hospital admission', 'A total of 132 patients were included']","['standard colonoscopy', 'Standard Colonoscopy']","['Recurrent bleedings and hospital readmissions', 'length of hospital stay (LOHS', '30-day mortality', 'number of patients diagnosed with a confirmed or presumptive bleeding source', 'yield of colonoscopy, blood transfusion requirements, recurrent bleedings, complications, interventions related to complications, and 30-day mortality', 'LOHS', 'blood transfusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0266811', 'cui_str': 'Acute lower gastrointestinal hemorrhage (disorder)'}, {'cui': 'C0024050', 'cui_str': 'Lower gastrointestinal hemorrhage (disorder)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",132.0,0.170084,"Recurrent bleedings and hospital readmissions were significantly more frequent in the <24-hour group: 13% versus 3% (P=0.04) and 11% versus 2% (P=0.02), respectively.","[{'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'van Rongen', 'Affiliation': 'Department of Gastroenterology.'}, {'ForeName': 'Bregje J W', 'Initials': 'BJW', 'LastName': 'Thomassen', 'Affiliation': 'Landsteiner Institute, Haaglanden Medical Centre, The Hague, The Netherlands.'}, {'ForeName': 'Lars E', 'Initials': 'LE', 'LastName': 'Perk', 'Affiliation': 'Department of Gastroenterology.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001048']
2366,32427014,Does Awareness of either Psychotropic Medication or Behavioral Interventions Bias College Students' Ratings of a Child's Behavior?,"Caregiver awareness that a child receives either psychotropic medication or behavioral intervention could bias that caregiver's perception of the child's behavior and give rise to incorrect conclusions about intervention effectiveness. To evaluate bias for the effects of either medication or behavioral intervention, we randomly assigned 114 participants to one of the four groups: Medication information (Med info), Behavioral information (Beh info), No change (control group), and Reverse video (Rev Vid; also no change, but participants watched videos in the reverse order). Participants watched two 5-min video clips of a child engaging in low to moderate levels of problem behavior. After watching the first video, participants rated the child's problem behavior. Before viewing the second video, participants were informed that (a) the child received medication (Med info group), (b) the child received behavioral intervention (Beh info group), or (c) no treatment changes were made (No change groups). Results show that providing treatment information did not bias participants' ratings of the child's behavior. Instead, results indicate participants in the control groups correctly tracked actual changes in the child's behavior.",2020,Results show that providing treatment information did not bias participants' ratings of the child's behavior.,['114 participants to one of the four groups'],"['psychotropic medication or behavioral intervention', 'behavioral intervention', 'Psychotropic Medication', 'Medication information (Med info), Behavioral information (Beh info), No change (control group), and Reverse video (Rev Vid; also no change, but participants watched videos in the reverse order', 'medication or behavioral intervention']",[],"[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]",[],114.0,0.0199728,Results show that providing treatment information did not bias participants' ratings of the child's behavior.,"[{'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Almanza', 'Affiliation': 'Auburn University, Auburn, AL, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Rapp', 'Affiliation': 'Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Kierce', 'Affiliation': 'Auburn University, Auburn, AL, USA.'}]",Developmental neurorehabilitation,['10.1080/17518423.2020.1764648']
2367,24286706,Protracted impairment of impulse control under an acute dose of alcohol: a time-course analysis.,"Alcohol is well-known for impairing impulse control as well as its disruptive effects on other aspects of behavioral functioning, such as motor control. Time-course analyses during a single dose show rapid development of acute tolerance to impairment of motor coordination, reaction time, and levels of subjective intoxication, but no acute tolerance to impairment of the ability to inhibit responses. Evidence for a possible lag in tolerance development to the impairing effects of alcohol on inhibitory control suggests that, as drinkers' blood alcohol concentration (BAC) declines, they might exhibit prolonged impulsivity despite having an unimpaired ability to initiate action. The present study extended the time-course analysis to examine the recovery of inhibitory control under a dose of alcohol as drinkers' BAC descended from a peak of 80 mg/100ml to a zero level. Twenty-four healthy adults were tested following 0.65 g/kg alcohol and a placebo in a counterbalanced order. They performed a cued go/no-go task that measured response inhibition. They also performed tasks that assessed reaction time, motor coordination, and completed ratings of their subjective levels of intoxication. Alcohol initially impaired inhibitory control, response time, and motor coordination and increased subjective ratings of intoxication. However, acute tolerance to the impairing effects of alcohol was observed for measures of response time, motor coordination, and ratings of intoxication and these measures returned to sober (i.e., placebo) levels by the time BAC fell to near zero. By contrast, impairment of inhibitory control showed no acute tolerance and remained impaired even when drinkers' BAC returned to near zero. Taken together, these results indicate that the disinhibiting effects of alcohol are present even when the impairing effects of alcohol on other aspects of behavior have diminished under the dose. These findings could provide a greater understanding of impulsive behaviors during the descending limb of intoxication.",2014,"Time-course analyses during a single dose show rapid development of acute tolerance to impairment of motor coordination, reaction time, and levels of subjective intoxication, but no acute tolerance to impairment of the ability to inhibit responses.",['Twenty-four healthy adults'],"['alcohol', 'placebo']","['motor coordination, reaction time, and levels of subjective intoxication', 'acute tolerance', 'reaction time, motor coordination, and completed ratings of their subjective levels of intoxication', 'inhibitory control, response time, and motor coordination and increased subjective ratings of intoxication', 'response time, motor coordination, and ratings of intoxication', 'impulsive behaviors']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}]",24.0,0.0340618,"Time-course analyses during a single dose show rapid development of acute tolerance to impairment of motor coordination, reaction time, and levels of subjective intoxication, but no acute tolerance to impairment of the ability to inhibit responses.","[{'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Miller', 'Affiliation': 'University of Kentucky, United States.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Fillmore', 'Affiliation': 'University of Kentucky, United States. Electronic address: fillmore@uky.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2013.10.035']
2368,32426989,A factorial randomized controlled trial to examine separate and combined effects of a simulation-based empathy enhancement program and a lecture-based education program on family caregivers of people with dementia.,"Objectives:  The present study was a 2 × 2 factorial randomized controlled trial that examined if a simulation-based empathy enhancement program and a lecture-based education program, together or separately, improved outcomes of family caregivers of people with dementia. Method:  A total of 101 participants were randomly assigned to simulation-based education only, lecture-based education only, simulation-based education plus lecture-based education, or treatment as usual. Data were analyzed using a two-way analysis of covariance while controlling for pretest results, kinship, and gender. Results:  Statistically significant interaction effects between the simulation program and the lecture program were found in the levels of well-being and helplessness. The lecture program accompanied by the simulation program led to higher level of well-being in terms of happiness and lower level of helplessness than the lecture program alone. Caregivers with the lecture program provided led to less frequent use of dysfunctional coping strategies than those with no lecture program provided. Caregivers with the simulation program provided led to more frequent use of emotion-focused coping strategies than those with no simulation program provided. Conclusions:  Findings of the present study support benefits of combined of and separate simulation-based and lecture-based programs on family caregivers of people with dementia in important outcomes affecting quality of care and quality of lives in families of people with dementia. Further studies are needed to identify intervention components that can improve empathy of family caregivers of people with dementia and be embedded into a multicomponent program tailored better to families in different needs.",2020,Caregivers with the simulation program provided led to more frequent use of emotion-focused coping strategies than those with no simulation program provided.,"['families of people with dementia', 'family caregivers of people with dementia', '101 participants']","['combined of and separate simulation-based and lecture-based programs', 'simulation-based empathy enhancement program and a lecture-based education program', 'simulation-based education only, lecture-based education only, simulation-based education plus lecture-based education, or treatment as usual']","['levels of well-being and helplessness', 'frequent use of dysfunctional coping strategies']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018897', 'cui_str': 'Learned Helplessness'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",101.0,0.0419198,Caregivers with the simulation program provided led to more frequent use of emotion-focused coping strategies than those with no simulation program provided.,"[{'ForeName': 'Areum', 'Initials': 'A', 'LastName': 'Han', 'Affiliation': 'Department of Occupational Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Tae Hui', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Yonsei University Wonju College of Medicine, Wonju, South Korea.'}, {'ForeName': 'Hyeon', 'Initials': 'H', 'LastName': 'Hong', 'Affiliation': 'Department of Occupational Therapy, Yonsei University, Wonju, South Korea.'}]",Aging & mental health,['10.1080/13607863.2020.1768214']
2369,32427108,User Experiences of an Internet-Based Stepped-Care Intervention for Individuals With Cancer and Concurrent Symptoms of Anxiety or Depression (the U-CARE AdultCan Trial): Qualitative Study.,"BACKGROUND


The internet-based stepped-care intervention iCAN-DO, used in the multicenter randomized controlled trial AdultCan, was developed for adult patients undergoing treatment for cancer and concurrently experiencing anxiety or depressive symptoms. iCAN-DO aimed to decrease symptoms of anxiety or depression. Step 1 comprises access to a library with psychoeducational material and a peer-support section, as well as the possibility to pose questions to a nurse. Step 2 of the intervention offers treatment consisting of internet-based cognitive behavioral therapy (iCBT) to participants still experiencing anxiety or depression at 1, 4, or 7 months after inclusion.
OBJECTIVE


The study aimed to explore user experiences of delivery, design, and structure of iCAN-DO from the perspective of people with cancer.
METHODS


We studied user experiences by interviewing 15 informants individually: 10 women with breast cancer (67%), 4 men with prostate cancer (27%), and 1 man with colorectal cancer (7%) with a mean age 58.9 years (SD 8.9). The interviews focused on informants' perceptions of ease of use and of system design and structure. Informants had been included in iCAN-DO for at least 7 months. They were purposefully selected based on activity in Step 1, participation in iCBT (ie, Step 2), gender, and diagnosis.
RESULTS


Of the 15 informants, 6 had been offered iCBT (40%). All informants used the internet on a daily basis, but 2 (13%) described themselves as very inexperienced computer users. The analysis revealed three subthemes, concerning how user experiences were affected by disease-specific factors and side effects (User experience in the context of cancer), technical problems (Technical struggles require patience and troubleshooting), and the structure and design of iCAN-DO (Appealing and usable, but rather simple).
CONCLUSIONS


The results indicate that user experiences were affected by informants' life situations, the technical aspects and the design of iCAN-DO, and informants' preferences. The results have generated some developments feasible to launch during the ongoing study, but if iCAN-DO is to be used beyond research interest, a greater level of tailoring of information, features, and design may be needed to improve user experiences. The use of recurrent questionnaires during the treatment period may highlight an individual's health, but also function as a motivator showing improvements over time.",2020,"The results indicate that user experiences were affected by informants' life situations, the technical aspects and the design of iCAN-DO, and informants' preferences.","['user experiences by interviewing 15 informants individually: 10 women with breast cancer (67%), 4 men with prostate cancer (27%), and 1 man with colorectal cancer (7%) with a mean age 58.9 years (SD 8.9', 'adult patients undergoing treatment for cancer and concurrently experiencing anxiety or depressive symptoms', 'Individuals With Cancer and Concurrent Symptoms of Anxiety or Depression', 'people with cancer']","['internet-based cognitive behavioral therapy (iCBT', 'Internet-Based Stepped-Care Intervention']",[],"[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],10.0,0.0532678,"The results indicate that user experiences were affected by informants' life situations, the technical aspects and the design of iCAN-DO, and informants' preferences.","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Igelström', 'Affiliation': 'Department of Neuroscience, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hauffman', 'Affiliation': 'Department of Immmunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Alfonsson', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Sjöström', 'Affiliation': 'Department of Informatics and Media, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Cajander', 'Affiliation': 'Department of Information Technology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Johansson', 'Affiliation': 'Department of Immmunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}]",Journal of medical Internet research,['10.2196/16604']
2370,32427107,The Effect of a Customized Nutrient-Profiling Approach on the Glycated Hemoglobin Levels of Patients With Type 2 Diabetes: Quasi-Experimental Study.,"BACKGROUND


Presently, dietary management approaches are mostly oriented toward using calorie-counting and diet-tracking tools that draw our attention away from the nutritional value of our food. To improve individuals' dietary behavior, primarily that of people with type 2 diabetes, a simple technique is needed to increase their understanding of the nutritional content of their food.
OBJECTIVE


This study aimed to design, develop, and evaluate a customized nutrient-profiling tool called EasyNutrition. EasyNutrition was built to introduce the new concept of nutrient profiling by applying the Intelligent Nutrition Engine, an algorithm that we developed for ranking different food recipes based on their nutritional value. This study also aimed to investigate the efficacy of EasyNutrition in lowering glycated hemoglobin (HbA 1c ) levels and improving dietary habits among people with type 2 diabetes.
METHODS


We evaluated the utility of EasyNutrition using design science research in three sequential stages. This paper has elaborated on the third stage to investigate the efficacy of EasyNutrition in managing type 2 diabetes. A quasi-experimental study was conducted in a diabetes treatment center (n=28). The intervention group utilized EasyNutrition over 3 months, whereas participants in the control group utilized the standard of care provided by the center. Dietary habits and HbA 1c  levels were measured to capture any change before and after experimenting with EasyNutrition.
RESULTS


The intervention group (n=9) exhibited a statistically significant change between the pre- and postexposure results of their HbA 1c  (t 9 =2.427; P=.04). Their HbA 1c  dropped from 8.13 to 6.72. This provided preliminary evidence of the efficacy of using a customized nutrient-profiling app in reducing HbA 1c  for people with type 2 diabetes.
CONCLUSIONS


This study adds to the evidence base that a nutrient-profiling strategy may be a modern adjunct to diabetes dietary management. In conjunction with reliable dietary education provided by a registered dietician, EasyNutrition may have some beneficial effects to improve the dietary habits of people with type 2 diabetes.",2020,The intervention group (n=9) exhibited a statistically significant change between the pre- and postexposure results of their HbA 1c  (t 9 =2.427; P=.04).,"['diabetes treatment center (n=28', 'people with type 2 diabetes', 'Patients With Type 2 Diabetes']","['Customized Nutrient-Profiling Approach', 'customized nutrient-profiling app', 'customized nutrient-profiling tool called EasyNutrition']","['Dietary habits and HbA 1c  levels', 'dietary habits', 'Glycated Hemoglobin Levels', 'glycated hemoglobin (HbA 1c ) levels']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0197754,The intervention group (n=9) exhibited a statistically significant change between the pre- and postexposure results of their HbA 1c  (t 9 =2.427; P=.04).,"[{'ForeName': 'Mayda', 'Initials': 'M', 'LastName': 'Alrige', 'Affiliation': 'King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Riad', 'Initials': 'R', 'LastName': 'Alharbey', 'Affiliation': 'University of Jeddah, Jeddah, Saudi Arabia.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Chatterjee', 'Affiliation': 'Claremont Graduate University, Claremont, CA, United States.'}]",Journal of medical Internet research,['10.2196/15497']
2371,31365099,Genetic Variation of the Vitamin D Binding Protein Affects Vitamin D Status and Response to Supplementation in Infants.,"CONTEXT


Single nucleotide polymorphisms (SNPs) of the vitamin D binding protein encoding the GC (group component) gene affect 25-hydroxyvitamin D (25OHD) concentrations, but their influence on vitamin D status and response to vitamin D supplementation in infants is unknown.
OBJECTIVE


To study GC genotype-related differences in 25OHD concentrations and the response to supplementation during a vitamin D intervention study in infants.
DESIGN


In this randomized controlled trial, healthy term infants received vitamin D3 (10 or 30 μg/d) from 2 weeks to 24 months of age. GC SNPs rs2282679, rs4588, rs7041, and rs1155563 were genotyped. rs4588/7041 diplotype and haplotypes of rs2282679, rs4588, and rs7041 (Haplo3SNP) and of all four SNPs (Haplo4SNP) were determined.
MAIN OUTCOME MEASURES


25OHD measured in cord blood at birth and at 12 and 24 months during intervention.
RESULTS


A total of 913 infants were included. Minor allele homozygosity of all studied GC SNPs, their combined haplotypes, and rs4588/rs7041 diplotype 2/2 were associated with lower 25OHD concentrations at all time points in one or both intervention groups [analysis of covariance (ANCOVA) P < 0.043], with the exception of rs7041, which did not affect 25OHD at birth. In the high-dose supplementation group receiving 30 μg/d vitamin D3, but not in those receiving 10 µg/d, genotype of rs2282679, rs4588, and rs7041; diplotype; and Haplo3SNP significantly affected intervention response (repeated measurement ANCOVA Pinteraction < 0.019). Minor allele homozygotes had lower 25OHD concentrations and smaller increases in 25OHD throughout the intervention.
CONCLUSIONS


In infants, vitamin D binding protein genotype affects 25OHD concentration and efficiency of high-dose vitamin D3 supplementation.",2019,"Minor allele homozygotes had lower 25OHD concentrations and smaller increase in 25OHD throughout intervention.
","['Altogether 913 infants were included', 'Infants', 'healthy term infants received 10 or 30 μg vitamin D3/day from 2 weeks to 24 months of age', 'infants']",['vitamin D supplementation'],"['25OHD measured in cord blood at birth', '25OHD concentrations', '25-hydroxyvitamin D (25OHD) concentrations']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",913.0,0.144209,"Minor allele homozygotes had lower 25OHD concentrations and smaller increase in 25OHD throughout intervention.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Enlund-Cerullo', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Koljonen', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Holmlund-Suila', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hauta-Alus', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Rosendahl', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Saara', 'Initials': 'S', 'LastName': 'Valkama', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Helve', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Hytinantti', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Viljakainen', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland.'}, {'ForeName': 'Sture', 'Initials': 'S', 'LastName': 'Andersson', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Mäkitie', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Pekkinen', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00630']
2372,24112099,Development of exchange lists for Mediterranean and Healthy Eating diets: implementation in an intervention trial.,"BACKGROUND


There has been little research published on the adaptation of diabetic exchange list diet approaches for the design of intervention diets in health research despite their clinical utility. The exchange list approach can provide clear and precise guidance on multiple dietary changes simultaneously. The present study aimed to develop exchange list diets for Mediterranean and Healthy Eating, and to evaluate adherence, dietary intakes and markers of health risks with each counselling approach in 120 subjects at increased risk for developing colon cancer.
METHODS


A randomised clinical trial was implemented in the USA involving telephone counselling. The Mediterranean diet had 10 dietary goals targeting increases in mono-unsaturated fats, n-3 fats, whole grains and the amount and variety of fruits and vegetables. The Healthy Eating diet had five dietary goals that were based on the US Healthy People 2010 recommendations.
RESULTS


Dietary compliance was similar in both diet arms, with 82-88% of goals being met at 6 months, although subjects took more time to achieve the Mediterranean goals than the Healthy Eating goals. The relatively modest fruit and vegetable goals in the Healthy Eating arm were exceeded, resulting in fruit and vegetable intakes of approximately eight servings per day in each arm after 6 months. A significant (P < 0.05) weight loss and a decrease in serum C-reactive protein concentrations were observed in the overweight/obese subgroup of subjects in the Mediterranean arm in the absence of weight loss goals.
CONCLUSIONS


Counselling for the Mediterranean diet may be useful for both improving diet quality and for achieving a modest weight loss in overweight or obese individuals.",2014,"A significant (P < 0.05) weight loss and a decrease in serum C-reactive protein concentrations were observed in the overweight/obese subgroup of subjects in the Mediterranean arm in the absence of weight loss goals.
","['overweight or obese individuals', 'Mediterranean and Healthy Eating diets', '120 subjects at increased risk for developing colon cancer']",[],"['diet quality', 'serum C-reactive protein concentrations', 'weight loss']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]",[],"[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0267304,"A significant (P < 0.05) weight loss and a decrease in serum C-reactive protein concentrations were observed in the overweight/obese subgroup of subjects in the Mediterranean arm in the absence of weight loss goals.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sidahmed', 'Affiliation': 'Department of Environmental Health Sciences, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Cornellier', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Askew', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Talaat', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Rapai', 'Affiliation': ''}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Ruffin', 'Affiliation': ''}, {'ForeName': 'D K', 'Initials': 'DK', 'LastName': 'Turgeon', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Brenner', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Djuric', 'Affiliation': ''}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12158']
2373,32426471,A brief social-belonging intervention in college improves adult outcomes for black Americans.,"Could mitigating persistent worries about belonging in the transition to college improve adult life for black Americans? To examine this question, we conducted a long-term follow-up of a randomized social-belonging intervention delivered in the first year of college. This 1-hour exercise represented social and academic adversity early in college as common and temporary. As previously reported in  Science , the exercise improved black students' grades and well-being in college. The present study assessed the adult outcomes of these same participants. Examining adult life at an average age of 27, black adults who had received the treatment (versus control) exercise 7 to 11 years earlier reported significantly greater career satisfaction and success, psychological well-being, and community involvement and leadership. Gains were statistically mediated by greater college mentorship. The results suggest that addressing persistent social-psychological concerns via psychological intervention can shape the life course, partly by changing people's social realities.",2020,"The results suggest that addressing persistent social-psychological concerns via psychological intervention can shape the life course, partly by changing people's social realities.","['Examining adult life at an average age of 27, black adults who had received the treatment (versus', 'black Americans']",['control) exercise'],"['career satisfaction and success, psychological well-being, and community involvement and leadership']","[{'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0009476', 'cui_str': 'Community Involvement'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}]",,0.0276882,"The results suggest that addressing persistent social-psychological concerns via psychological intervention can shape the life course, partly by changing people's social realities.","[{'ForeName': 'Shannon T', 'Initials': 'ST', 'LastName': 'Brady', 'Affiliation': 'Department of Psychology, Wake Forest University, Greene Hall, P.O. Box 7778, Reynolda Hall, Winston-Salem, NC, USA.'}, {'ForeName': 'Geoffrey L', 'Initials': 'GL', 'LastName': 'Cohen', 'Affiliation': 'Graduate School of Education and Department of Psychology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Shoshana N', 'Initials': 'SN', 'LastName': 'Jarvis', 'Affiliation': 'Haas School of Business, University of California, Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Walton', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA, USA.'}]",Science advances,['10.1126/sciadv.aay3689']
2374,31250880,A phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma.,"BACKGROUND


The CDK4/6 inhibitor palbociclib prolongs progression-free survival in hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer when combined with endocrine therapy. This phase II trial was designed to determine the feasibility of adjuvant palbociclib and endocrine therapy for early breast cancer.
PATIENTS AND METHODS


Eligible patients with HR+/HER2- stage II-III breast cancer received 2 years of palbociclib at 125 mg daily, 3 weeks on/1 week off, with endocrine therapy. The primary end point was discontinuation from palbociclib due to toxicity, non-adherence, or events related to tolerability. A discontinuation rate of 48% or higher would indicate the treatment duration of 2 years was not feasible, and was evaluated under a binomial test using a one-sided α = 0.025.
RESULTS


Overall, 162 patients initiated palbociclib; over half had stage III disease (52%) and most received prior chemotherapy (80%). A total of 102 patients (63%) completed 2 years of palbociclib; 50 patients discontinued early for protocol-related reasons (31%, 95% CI 24% to 39%, P = 0.001), and 10 discontinued due to protocol-unrelated reasons. The cumulative incidence of protocol-related discontinuation was 21% (95% CI 14% to 27%) at 12 months from start of treatment. Rates of palbociclib-related toxicity were congruent with the metastatic experience, and there were no cases of febrile neutropenia. Ninety-one patients (56%) required at least one dose reduction.
CONCLUSION


Adjuvant palbociclib is feasible in early breast cancer, with a high proportion of patients able to complete 2 years of therapy. The safety profile in the adjuvant setting mirrors that observed in metastatic disease, with approximately half of the patients requiring dose-modification. As extended duration adjuvant palbociclib appears feasible and tolerable for most patients, randomized phase III trials are evaluating clinical benefit in this population.
CLINICALTRIALS.GOV REGISTRATION


NCT02040857.",2019,The cumulative incidence of protocol-related discontinuation was 21% (95%CI 14-27%) at 12 months from start of treatment.,"['Eligible patients with HR+/HER2- stage II-III breast cancer received 2 years of', 'early breast cancer', '162 patients initiated palbociclib; over half had stage III disease (52%) and most received prior chemotherapy (80', '102 patients (63%) completed 2 years of palbociclib; 50 patients discontinued early for protocol-related reasons (31%, 95%CI 24-39%, p\u2009=\u20090.001), and 10 discontinued due to protocol-unrelated reasons', 'Hormone Receptor Positive Invasive Breast Carcinoma']","['Adjuvant Endocrine Therapy', 'Palbociclib', 'Adjuvant palbociclib', 'palbociclib', 'endocrine therapy', 'adjuvant palbociclib and endocrine therapy']","['Rates of palbociclib-related toxicity', 'cumulative incidence of protocol-related discontinuation', 'febrile neutropenia', 'discontinuation from palbociclib due to toxicity, non-adherence, or events related to tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C4517385', 'cui_str': '0.001 (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast (disorder)'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",102.0,0.0564235,The cumulative incidence of protocol-related discontinuation was 21% (95%CI 14-27%) at 12 months from start of treatment.,"[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Mayer', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston. Electronic address: emayer@partners.org.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'DeMichele', 'Affiliation': 'Division of Hematology and Oncology, University of Pennsylvania Abramson Cancer Center, Philadelphia.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Division of Hematology and Medical Oncology, University of California San Francisco Helen Diller Comprehensive Cancer Center, San Francisco.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Division of Hematology/Oncology, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Waks', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.""}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Come', 'Affiliation': 'Division of Hematology and Oncology, Beth Israel Deaconess Medical Center, Boston.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mulvey', 'Affiliation': 'Division of Hematology and Oncology, Massachusetts General Hospital Cancer Center, Boston.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jeselsohn', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Overmoyer', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston.'}, {'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Barry', 'Affiliation': 'Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Huang Bartlett', 'Affiliation': 'Pfizer, Inc., New York, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koehler', 'Affiliation': 'Pfizer, Inc., New York, USA.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.""}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Burstein', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz198']
2375,23795976,Effect of complementary feeding with lipid-based nutrient supplements and corn-soy blend on the incidence of stunting and linear growth among 6- to 18-month-old infants and children in rural Malawi.,"Low nutritional value of complementary foods is associated with high incidence of childhood growth stunting in low-income countries. This study was done to test a hypothesis that dietary complementation with lipid-based nutrient supplements (LNS) promotes linear growth and reduces the incidence of severe stunting among at-risk infants. A total of 840 6-month-old healthy infants in rural Malawi were enrolled to a randomised assessor-blinded trial. The participants received 12-month supplementation with nothing, milk-LNS, soy-LNS, or corn-soy blend (CSB). Supplements provided micronutrients and approximately 280 kcal energy per day. Outcomes were incidence of severe and very severe stunting [length-for-age z-score, (LAZ) < -3.00 and <-3.50, respectively], and change in LAZ. The incidence of severe stunting was 11.8%, 8.2%, 9.1% and 15.5% (P = 0.098) and that of very severe stunting 7.4%, 2.9%, 8.0% and 6.4% (P = 0.138) in control, milk-LNS, soy-LNS and CSB groups, respectively. Between 9 and 12 months of age, the mean change in LAZ was -0.15, -0.02, -0.12 and -0.18 (P = 0.045) for control, milk-LNS, soy-LNS and CSB groups, respectively. There was no significant between-group difference in linear growth during other age-intervals. Although participants who received milk-LNS had the lowest incidence of severe and very severe stunting, the differences between the groups were smaller than expected. Thus, the results do not provide conclusive evidence on a causal association between the LNS supplementation and the lower incidence of stunting. Exploratory analyses suggest that provision of milk-LNS, but not soy-LNS promotes linear growth among at-risk infants mainly between 9 and 12 months of age.",2015,"Between 9 and 12 months of age, the mean change in LAZ was -0.15, -0.02, -0.12 and -0.18 (P = 0.045) for control, milk-LNS, soy-LNS and CSB groups, respectively.","['A total of 840 6-month-old healthy infants in rural Malawi', 'severe stunting among at-risk infants', '6- to 18-month-old infants and children in rural Malawi']","['dietary complementation with lipid-based nutrient supplements (LNS', '12-month supplementation with nothing, milk-LNS, soy-LNS, or corn-soy blend (CSB', 'complementary feeding with lipid-based nutrient supplements and corn-soy blend']","['linear growth', 'lowest incidence of severe and very severe stunting', 'incidence of severe and very severe stunting [length-for-age z-score, (LAZ', 'incidence of stunting and linear growth', 'mean change in LAZ', 'incidence of severe stunting']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",840.0,0.0361126,"Between 9 and 12 months of age, the mean change in LAZ was -0.15, -0.02, -0.12 and -0.18 (P = 0.045) for control, milk-LNS, soy-LNS and CSB groups, respectively.","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Mangani', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Phuka', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Yin Bun', 'Initials': 'YB', 'LastName': 'Cheung', 'Affiliation': 'University of Tampere, School of Medicine, Tampere, Finland.'}, {'ForeName': 'Chrissie', 'Initials': 'C', 'LastName': 'Thakwalakwa', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Dewey', 'Affiliation': 'University of California, Davis, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Manary', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Taneli', 'Initials': 'T', 'LastName': 'Puumalainen', 'Affiliation': 'Ministry for Social Affairs and Health, Tampere, Finland.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'University of Tampere, School of Medicine, Tampere, Finland.'}]",Maternal & child nutrition,['10.1111/mcn.12068']
2376,32421603,Efficacy and cost-effectiveness of intensive short-term dynamic psychotherapy for treatment resistant depression: 18-Month follow-up of the Halifax depression trial.,"BACKGROUND


Depressed patients with chronic and complex health issues commonly relapse; therefore, examining longer-term outcomes is an important consideration. For treatment resistant depression (TRD), the post-treatment efficacy of time-limited Intensive Short-Term Dynamic Psychotherapy (ISTDP) has been demonstrated but longer-term outcomes and cost-effectiveness are unclear.
METHOD


In this superiority trial, 60 patients referred to Community Mental Health Teams (CMHT) were randomised to 2 groups (ISTDP=30 and CMHT=30). The primary outcome was Hamilton Depression Rating scale (HAM-D) scores at 18 months. Secondary outcomes included Patient Health Questionnaire (PHQ-9) depression scores and dichotomous measure remission. A health economic evaluation examined mental health costs with quality-adjusted life years (QALYs).
RESULTS


Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up. Group differences in depression were in the moderate to large range on both the observer rated (Cohen's d = .64) and self-report measures (Cohen's d = .70). At 18 months follow-up the remission rate in ISTDP patients was 40.0%, and 23.4% had discontinued antidepressants. Health economic analysis suggests that ISTDP was more cost-effective than CMHT at 18 months. Probabilistic analysis suggests that there is a 64.5% probability of ISTDP being cost-effective at a willingness to pay for a QALY of $25,000 compared to CMHT at 18 months.
LIMITATIONS


Replication of these findings is necessary in larger samples and future cost analyses should also consider indirect costs.
CONCLUSIONS


ISTDP demonstrates long-term efficacy and cost-effectiveness in TRD.",2020,Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up.,['60 patients referred to Community Mental Health Teams (CMHT'],"['ISTDP', 'intensive short-term dynamic psychotherapy', 'time-limited Intensive Short-Term Dynamic Psychotherapy (ISTDP']","['Hamilton Depression Rating scale (HAM-D) scores', 'Efficacy and cost-effectiveness', 'Patient Health Questionnaire (PHQ-9) depression scores and dichotomous measure remission', 'remission rate', 'depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0332186', 'cui_str': 'Definite time'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",60.0,0.0697056,Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up.,"[{'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Town', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada. Electronic address: joel.town@dal.ca.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbass', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Stride', 'Affiliation': 'The Institute of Work Psychology, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry & Faculty of Computer Science, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bernier', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Berrigan', 'Affiliation': 'Research Methods Unit, Nova Scotia Health Authority, Halifax, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2020.04.035']
2377,24081874,Quality of life for parents of children with influenza-like illness: development and validation of Care-ILI-QoL.,"PURPOSE


Influenza-like illnesses (ILI) cause paediatric morbidity and affect the quality of life (QoL) of children and their parents. We have developed a disease-specific questionnaire (Care-ILI-QoL) to measure the QoL of caregivers of children with ILI.
METHODS


The drafting of the Care-ILI-QoL questionnaire was based on a systematic review, a quantitative survey, qualitative interviews with parents, and meetings with paediatricians. Children aged 6-48 months recruited from childcare centres in Sydney, Australia, were followed up during the 2011 influenza season. Care-ILI-QoL and SF-12v2 Acute Form were administered to the parent of a sick child 2 weeks after the onset of ILI, and again 2 weeks after the child had recovered. Exploratory factor analysis was conducted. Internal consistency, concurrent validity, discriminant validity, homogeneity of items, and responsiveness were tested.
RESULTS


Out of the 125 children enrolled from 48 childcare centres, 55 children had ILI (total 75 ILI episodes). Care-ILI-QoL was reduced from 25 to 16 items covering four factors: Daily Activities, Perceived Support, Social Life, and Emotions (Cronbach's alphas 0.90, 0.92, 0.78, and 0.72, respectively). Care-ILI-QoL has satisfactory concurrent and discriminant validity, good internal consistency, and excellent responsiveness. Total QoL and factor scores correlated well with SF-12v2 scores. Total QoL scores were significantly lower in parents who perceived their child as very/extremely sick, sacrificed 10 hours or more in work or recreation in caring for the child, or whose child had two or more general practitioner visits. Total QoL and factor scores were significantly higher after the child had recovered than when the child had ILI.
CONCLUSIONS


Care-ILI-QoL is the first ILI-specific QoL instrument for parents and is demonstrated to be valid and reliable in a developed country setting where the child is affected by ILI. It has the potential to be applied in clinical and research settings to assist measurement of disease burden, as a needs assessment tool for resources or to inform policy changes.",2014,"Total QoL scores were significantly lower in parents who perceived their child as very/extremely sick, sacrificed 10 hours or more in work or recreation in caring for the child, or whose child had two or more general practitioner visits.","['parents of children with influenza-like illness', 'children and their parents', '125 children enrolled from 48 childcare centres, 55 children had ILI (total 75 ILI episodes', 'Children aged 6-48\xa0months recruited from childcare centres in Sydney, Australia, were followed up during the 2011 influenza season']",[],"['Total QoL scores', 'Quality of life', 'Total QoL and factor scores', 'quality of life (QoL', 'Care-ILI-QoL', 'Internal consistency, concurrent validity, discriminant validity, homogeneity of items, and responsiveness']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521839', 'cui_str': 'Influenza-like illness (finding)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",125.0,0.0299563,"Total QoL scores were significantly lower in parents who perceived their child as very/extremely sick, sacrificed 10 hours or more in work or recreation in caring for the child, or whose child had two or more general practitioner visits.","[{'ForeName': 'Maria Yui Kwan', 'Initials': 'MY', 'LastName': 'Chow', 'Affiliation': ""National Centre for Immunisation Research and Surveillance (NCIRS), Kids Research Institute, The Children's Hospital at Westmead, Cnr Hawkesbury Road and Hainsworth Street, Locked Bag 4001, Sydney, NSW, 2145, Australia, maria.chow@health.nsw.gov.au.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Morrow', 'Affiliation': ''}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Heron', 'Affiliation': ''}, {'ForeName': 'Jiehui Kevin', 'Initials': 'JK', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Booy', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Leask', 'Affiliation': ''}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-013-0538-y']
2378,24046302,Racial differences in response to antiretroviral therapy for HIV infection: an AIDS clinical trials group (ACTG) study analysis.,"BACKGROUND


In the United States, black individuals infected with human immunodeficiency virus (HIV) have higher rates of virologic failure on antiretroviral therapy (ART) and of death compared to white individuals. The cause for these disparities is uncertain. We sought to examine differences in virologic outcomes among antiretroviral-naive clinical trial participants starting randomized ART and to investigate factors to explain the differences.
METHODS


Individual-level data from participants initiating ART in 5 AIDS Clinical Trials Group studies were analyzed. Included studies were those conducted during 1998-2006 with a primary outcome of virologic failure. The primary outcome measure was time to virologic failure, regardless of ART changes.
RESULTS


A total of 2495 individuals (1151 black; 1344 white) were included with a median follow-up of 129 weeks. Compared to whites, blacks had an increased hazard of virologic failure (hazard ratio [HR]; 1.7; 95% confidence interval [CI], 1.4-1.9; P < .001), with no evidence of heterogeneity across regimens (P = .97); the association remained after adjustment for measured confounders (HR, 1.4; 95% CI, 1.2-1.6; P < .001). Increased hazard of virologic failure was associated with younger age, higher pretreatment HIV type 1 RNA level, lower pretreatment CD4 cell count, hepatitis C antibody, less education, and recent nonadherence to treatment. Sensitivity analyses with different endpoint definitions demonstrated similar results.
CONCLUSIONS


In this analysis, blacks had a 40% higher virologic failure risk than whites that was not explained by measured confounders. The observation was consistent over a range of regimens, suggesting that the difference may be driven by social factors; however, biological factors cannot be ruled out. Further research should identify the sources of racial disparities and develop strategies to reduce them.",2013,"Increased hazard of virologic failure was associated with younger age, higher pretreatment HIV type 1 RNA level, lower pretreatment CD4 cell count, hepatitis C antibody, less education, and recent nonadherence to treatment.","['black individuals infected with human immunodeficiency virus (HIV', 'A total of 2495 individuals (1151 black; 1344 white) were included with a median follow-up of 129 weeks', 'HIV infection']",[],"['time to virologic failure, regardless of ART changes', 'virologic failure risk', 'virologic failure', 'hazard of virologic failure', 'virologic outcomes', 'Increased hazard of virologic failure']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",2495.0,0.55661,"Increased hazard of virologic failure was associated with younger age, higher pretreatment HIV type 1 RNA level, lower pretreatment CD4 cell count, hepatitis C antibody, less education, and recent nonadherence to treatment.","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Robbins', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Flexner', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haubrich', 'Affiliation': ''}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Fischl', 'Affiliation': ''}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': ''}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Riddler', 'Affiliation': ''}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Gulick', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/cit595']
2379,32426882,A randomized Controlled Trial of Different Young Child Formulas on Upper Respiratory and Gastrointestinal Tract Infections in Chinese Toddlers.,"BACKGROUND


Bioactive proteins and human milk oligosaccharides (HMOs), important ingredients in breastmilk, that protect against infections are lacking in young child formula (YCF). This study investigated the effects of new YCFs on respiratory and gastrointestinal infections in toddlers.
METHODS


461 healthy Chinese children aged 1-2.5 years were recruited in this randomized, controlled, double-blind, parallel-group clinical trial of different YCFs. They were randomly assigned to either standard milk formula (YCF-Ref) or one of three new YCFs containing bioactive proteins and/or the HMO 2'-fucosyllactose (2'-FL) and/or milk fat for six months. Primary outcomes were incidence of upper respiratory tract infection (URTI) and duration of gastrointestinal tract infections (GITI).
RESULTS


There were no significant between-group differences in primary outcomes. For secondary outcomes, subjects receiving 2'-FL-supplemented YCF had longer URTI. Subjects receiving YCF supplemented with milk fat and intact bioactive proteins, and 2'-FL at levels found in breastmilk, had more GITI episodes and shorter time to first GITI but similar effects on URTI duration than YCF-Ref recipients. No effects on URTI and GITI were observed in toddlers receiving YCF with bioactive proteins at lower levels than breastmilk. Occurrence of adverse events and anthropometry were similar in all groups.
CONCLUSIONS


All three YCFs supplemented with different combinations of intact bioactive proteins, 2'-FL and milk fat are safe in toddlers. No difference is detected among YCFs on URTI incidence and GITI duration. Further studies are needed to verify these findings especially in infants who may benefit most from the immune-boosting effects of bioactive proteins and HMOs.",2020,No effects on URTI and GITI were observed in toddlers receiving YCF with bioactive proteins at lower levels than breastmilk.,"['461 healthy Chinese children aged 1-2.5 years', 'Chinese Toddlers', 'toddlers']","['new YCFs', 'YCF', ""2'-FL-supplemented YCF"", ""standard milk formula (YCF-Ref) or one of three new YCFs containing bioactive proteins and/or the HMO 2'-fucosyllactose (2'-FL) and/or milk fat for six months""]","['URTI and GITI', 'Upper Respiratory and Gastrointestinal Tract Infections', 'longer URTI', 'URTI incidence and GITI duration', 'incidence of upper respiratory tract infection (URTI) and duration of gastrointestinal tract infections (GITI', 'URTI duration']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0045214', 'cui_str': ""2'-fucosyllactose""}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018720', 'cui_str': 'Health maintenance organization'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",461.0,0.0815698,No effects on URTI and GITI were observed in toddlers receiving YCF with bioactive proteins at lower levels than breastmilk.,"[{'ForeName': 'Ting F', 'Initials': 'TF', 'LastName': 'Leung', 'Affiliation': 'Departments of Paediatrics, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Laurien H', 'Initials': 'LH', 'LastName': 'Ulfman', 'Affiliation': 'FrieslandCampina, Amersfoort, the Netherlands.'}, {'ForeName': 'Marc K C', 'Initials': 'MKC', 'LastName': 'Chong', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Kam L', 'Initials': 'KL', 'LastName': 'Hon', 'Affiliation': 'Departments of Paediatrics, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Ilse M S L', 'Initials': 'IMSL', 'LastName': 'Khouw', 'Affiliation': 'FrieslandCampina, Amersfoort, the Netherlands.'}, {'ForeName': 'Paul K S', 'Initials': 'PKS', 'LastName': 'Chan', 'Affiliation': 'Microbiology, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Dianne J', 'Initials': 'DJ', 'LastName': 'Delsing', 'Affiliation': 'FrieslandCampina, Amersfoort, the Netherlands.'}, {'ForeName': 'Guus A M', 'Initials': 'GAM', 'LastName': 'Kortman', 'Affiliation': 'NIZO, Ede, the Netherlands.'}, {'ForeName': 'Ingeborg M J', 'Initials': 'IMJ', 'LastName': 'Bovee-Oudenhoven', 'Affiliation': 'FrieslandCampina, Amersfoort, the Netherlands.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13276']
2380,31512717,Long-term safety and efficacy of alirocumab in South African patients with heterozygous familial hypercholesterolaemia: the ODYSSEY Open-Label Extension study.,"BACKGROUND


Alirocumab reduces low-density lipoprotein cholesterol (LDL-C) levels by up to 61%. The ODYSSEY Open-Label Extension study investigated the effect of alirocumab in patients with heterozygous familial hypercholesterolaemia (HeFH) over 144 weeks.
METHODS


Eligible patients with HeFH had completed an earlier double-blind, randomised, placebo-controlled parent study. Patients were initiated on 75 mg alirocumab Q2W subcutaneous (SC) unless baseline LDL-C was > 8.9 mmol/l, in which case they received 150 mg alirocumab Q2W. Dose titration to 150 mg Q2W was at the investigator's discretion.
RESULTS


The study enrolled 167 patients and the parent study mean (± SD) baseline LDL-C level was 3.65 ± 1.9 mmol/l. Mean LDL-C level was reduced by 48.7% at week 144; mean on-treatment LDL-C was 2.30 ± 1.24 mmol/l. Eight patients reported injection-site reactions, with one treatment discontinuation. Treatment emergent anti-drug antibodies were identified in five patients but these did not affect the efficacy.
CONCLUSIONS


Alirocumab effectively and safely reduced LDL-C in these patients.",2019,Mean LDL-C level was reduced by 48.7% at week 144; mean on-treatment LDL-C was 2.30 ± 1.24 mmol/l.,"['South African patients with heterozygous familial hypercholesterolaemia', '167 patients and the parent study mean (± SD) baseline LDL-C level was 3.65 ± 1.9 mmol/l', 'Eligible patients with HeFH had completed an earlier double-blind, randomised', 'patients with heterozygous familial hypercholesterolaemia (HeFH) over 144 weeks']","['placebo', 'alirocumab Q2W subcutaneous (SC', 'alirocumab']","['injection-site reactions', 'efficacy', 'Mean LDL-C level', 'low-density lipoprotein cholesterol (LDL-C) levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous (disorder)'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]",167.0,0.144121,Mean LDL-C level was reduced by 48.7% at week 144; mean on-treatment LDL-C was 2.30 ± 1.24 mmol/l.,"[{'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'Blom', 'Affiliation': 'Department of Medicine, Division of Lipidology and Hatter Institute for Cardiovascular Research in Africa, University of Cape Town, Cape Town, South Africa. Email: dirk.blom@uct.ac.za.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Breedt', 'Affiliation': 'Emmed Research, Pretoria West, South Africa.'}, {'ForeName': 'Lesley J', 'Initials': 'LJ', 'LastName': 'Burgess', 'Affiliation': 'Tread Research, Department of Cardiology, Faculty of Medicine and Health Science, University of Stellenbosch, Stellenbosch, South Africa.'}, {'ForeName': 'Iftikhar O', 'Initials': 'IO', 'LastName': 'Ebrahim', 'Affiliation': 'Netcare Unitas Hospital, Centurion, South Africa.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Ellis', 'Affiliation': 'Synexus Helderberg Clinical Trial Centre, Somerset West, South Africa.'}, {'ForeName': 'Prashilla', 'Initials': 'P', 'LastName': 'Soma', 'Affiliation': 'Clinical Research Unit, Department of Clinical Research, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'van der Walt', 'Affiliation': 'Roodepoort Medicross Clinical Research Centre, Synexus Affiliated Site, Roodepoort, South Africa.'}, {'ForeName': 'Poobalan', 'Initials': 'P', 'LastName': 'Naidoo', 'Affiliation': 'Sanofi, Johannesburg, South Africa.'}, {'ForeName': 'Alet', 'Initials': 'A', 'LastName': 'van Tonder', 'Affiliation': 'Sanofi, Johannesburg, South Africa.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Raal', 'Affiliation': 'Carbohydrate and Lipid Metabolism Research Unit, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.'}]",Cardiovascular journal of Africa,['10.5830/CVJA-2019-039']
2381,23782554,Comparison of the effectiveness of a milk-free soy-maize-sorghum-based ready-to-use therapeutic food to standard ready-to-use therapeutic food with 25% milk in nutrition management of severely acutely malnourished Zambian children: an equivalence non-blinded cluster randomised controlled trial.,"Community-based Management of Acute Malnutrition using ready-to-use therapeutic food (RUTF) has revolutionised the treatment of severe acute malnutrition (SAM). However, 25% milk content in standard peanut-based RUTF (P-RUTF) makes it too expensive. The effectiveness of milk-free RUTF has not been reported hitherto. This non-blinded, parallel group, cluster randomised, controlled, equivalence trial that compares the effectiveness of a milk-free soy-maize-sorghum-based RUTF (SMS-RUTF) with P-RUTF in treatment of children with SAM, closes the gap. A statistician randomly assigned health centres (HC) either to the SMS-RUTF (n = 12; 824 enrolled) or P-RUTF (n = 12; 1103 enrolled) arms. All SAM children admitted at the participating HCs were enrolled. All the outcomes were measured at individual level. Recovery rate was the primary outcome. The recovery rates for SMS-RUTF and P-RUTF were 53.3% and 60.8% for the intention-to-treat (ITT) analysis and 77.9% and 81.8% for per protocol (PP) analyses, respectively. The corresponding adjusted risk difference (ARD) and 95% confidence interval, were -7.6% (-14.9, 0.6%) and -3.5% (-9,6., 2.7%) for ITT (P = 0.034) and PP analyses (P = 0.257), respectively. An unanticipated interaction (interaction P < 0.001 for ITT analyses and 0.0683 for PP analyses) between the study arm and age group was observed. The ARDs were -10.0 (-17.7 to -2.3)% for ITT (P = 0.013) and -4.7 (-10.0 to 0.7) for PP (P = 0.083) analyses for the <24 months age group and 2.1 (-10.3,14.6)% for ITT (P = 0.726) and -0.6 (-16.1, 14.5) for PP (P = 0.939) for the ≥24 months age group. In conclusion, the study did not confirm our hypothesis of equivalence between SMS-RUTF and P-RUTF in SAM management.",2015,An unanticipated interaction (interaction P < 0.001 for ITT analyses and 0.0683 for PP analyses) between the study arm and age group was observed.,"['severe acute malnutrition (SAM', 'n\u2009=\u200912; 824 enrolled) or P-RUTF (n\u2009=\u200912; 1103 enrolled) arms', 'children with SAM, closes the gap', 'All SAM children admitted at the participating HCs were enrolled', 'severely acutely malnourished Zambian children']","['milk-free RUTF', 'milk-free soy-maize-sorghum-based RUTF (SMS-RUTF) with P-RUTF', 'ready-to-use therapeutic food (RUTF', 'milk-free soy-maize-sorghum-based ready-to-use therapeutic food to standard ready-to-use therapeutic food with 25% milk', 'SMS-RUTF']","['Recovery rate', 'recovery rates for SMS-RUTF and P-RUTF']","[{'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0331570', 'cui_str': 'Sorghum'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],,0.11533,An unanticipated interaction (interaction P < 0.001 for ITT analyses and 0.0683 for PP analyses) between the study arm and age group was observed.,"[{'ForeName': 'Abel H', 'Initials': 'AH', 'LastName': 'Irena', 'Affiliation': 'Valid International, Oxford, UK.'}, {'ForeName': 'Paluku', 'Initials': 'P', 'LastName': 'Bahwere', 'Affiliation': 'Valid International, Oxford, UK.'}, {'ForeName': 'Victor O', 'Initials': 'VO', 'LastName': 'Owino', 'Affiliation': 'Valid Nutrition, Nairobi, Kenya.'}, {'ForeName': 'ElHadji I', 'Initials': 'EI', 'LastName': 'Diop', 'Affiliation': 'Valid International, Oxford, UK.'}, {'ForeName': 'Max O', 'Initials': 'MO', 'LastName': 'Bachmann', 'Affiliation': 'University of East Anglia, East Anglia, UK.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Mbwili-Muleya', 'Affiliation': 'Lusaka District Health Management Team, Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Dibari', 'Affiliation': 'Valid International, Oxford, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sadler', 'Affiliation': 'Valid International, Oxford, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': 'Valid International, Oxford, UK.'}]",Maternal & child nutrition,['10.1111/mcn.12054']
2382,32426522,HbA1c as a predictor for response of bevacizumab in diabetic macular oedema.,"Objective


To study the influence of glycosylated haemoglobin (HbA1c) on response of bevacizumab in patients with diabetic macular oedema.
Methods and Analysis


A total of 37 eyes of 37 patients with vision loss due to diabetic macular oedema treated with bevacizumab were included in this study. Participants received monthly intravitreal bevacizumab (0.05 mL/1.25 mg) for 3 months.
Results


There were 17 patients with baseline HbA1c ≤7% (<53mmol/mol) and 20 patients with baseline HbA1c >7% (>53mmol/mol) treated with bevacizumab included in the study. The mean improvement in visual acuity at 3 months was 0.50 logMAR in HbA1c ≤7%(<53mmol/mol) group and 0.33 logMAR in HbA1c >7%(>53mmol/mol) group (95% CI,-0.05-0.38; p=0.13). The mean central macular thickness (CMT) reduction was -229.76 µm in patients with a baseline HbA1c ≤7% (<53 mmol/mol) and -145.20 µm in patients with HbA1c of >7% (>53mmol/mol) (95% CI,12.98-156.14; p=0.022).
Conclusion


Our study suggests that baseline glycaemic control can affect the treatment outcome of intravitreal bevacizumab in the management of diabetic macular oedema and the response was found to be better in patients with good glycaemic control (low HbA1c).",2020,The mean central macular thickness (CMT) reduction was -229.76 ,"['patients with diabetic macular oedema', '17 patients with baseline HbA1c ≤7% (<53mmol/mol) and 20 patients with baseline HbA1c >7% (>53mmol/mol) treated with', '37 eyes of 37 patients with vision loss due to diabetic macular oedema treated with', 'diabetic macular oedema', 'patients with good glycaemic control (low HbA1c']","['glycosylated haemoglobin (HbA1c', 'intravitreal bevacizumab', 'bevacizumab']","['visual acuity', 'diabetic macular oedema', 'mean central macular thickness (CMT) reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",37.0,0.0643104,The mean central macular thickness (CMT) reduction was -229.76 ,"[{'ForeName': 'Sadhana', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Ophthalmology, Mechi Eye Hospital, Jhapa, Nepal.'}, {'ForeName': 'Sagun Narayan', 'Initials': 'SN', 'LastName': 'Joshi', 'Affiliation': 'Department of Retina, B.P. Koirala Lions Center for Ophthalmic Studies, Institute of Medicine, Kathmandu, Nepal.'}, {'ForeName': 'Pratap', 'Initials': 'P', 'LastName': 'Karki', 'Affiliation': 'Department of Retina, B.P. Koirala Lions Center for Ophthalmic Studies, Institute of Medicine, Kathmandu, Nepal.'}]",BMJ open ophthalmology,['10.1136/bmjophth-2020-000449']
2383,32426884,"Disparate effects of adalimumab and fumaric acid esters on cardiovascular risk factors in psoriasis patients: Results from a prospective, randomized, observer-blinded head-to-head trial.","BACKGROUND


The effect of adalimumab and fumaric acid esters (FAE) on the cardiovascular risk associated with psoriasis has only been investigated scarcely in randomized controlled studies.
OBJECTIVE


The aim of this prospective, randomized controlled head-to-head trial was to compare the influence of adalimumab and FAE on cardiovascular disease markers in psoriasis patients.
METHODS


65 patients with moderate to severe plaque psoriasis were randomly assigned to adalimumab or FAE treatment for 6 months. Cardiovascular hemodynamic parameters (flow mediated dilation (FMD), nitro-glycerine mediated dilation (NMD) and carotid intima media thickness (CIMT), blood pressure) were assessed at baseline(v0) and after 6 months(v6). Cutaneous disease severity, inflammatory and lipid cardiovascular risk markers were analysed at baseline(v0), after three(v3) and six months(v6).
RESULTS


After 6 months of treatment FMD in the adalimumab group increased significantly (v0 5,9% (6,4% S.D), v6 8,0% (4,8% S.D.), p=0,048) but not in the FAE group. (v0 7,0% (4,1% S.D), v6 8,4% (6,1% S.D.), p=0,753) This was paralleled by a significant decrease of hsCRP in the adalimumab group in comparison to the FAE group (v0: 0,39 mg/dl (0,38 S.D.), v6: 0,39mg/dl (0,48 S.D.), p=0,043). No significant changes were observed in any other hemodynamic parameters. FAE, however, additionally decreased total cholesterol (p=0,046) and apolipoprotein B (p=0,041) levels compared to adalimumab. Mean PASI (psoriasis area severity score) reduction was greater but not significant (p=0,116) under adalimumab treatment compared to FAE treatment ( -71,1% (29,9 S.D) vs. -54,6% (45,7%)).
CONCLUSION


In our study both treatments were documented to exert effects on the cardiovascular system. While adalimumab showed anti-inflammatory effects and improved FMD, FAE interacted favourably with the cholesterol metabolism.",2020,This was paralleled by a significant decrease of hsCRP in the adalimumab group in comparison to the FAE group (v0:,"['65 patients with moderate to severe plaque psoriasis', 'psoriasis patients']","['adalimumab and fumaric acid esters (FAE', 'adalimumab or FAE', 'adalimumab', 'adalimumab and FAE', 'adalimumab and fumaric acid esters', 'FAE']","['hsCRP', 'Mean PASI (psoriasis area severity score) reduction', 'total cholesterol (p=0,046) and apolipoprotein B (p=0,041) levels', 'Cardiovascular hemodynamic parameters (flow mediated dilation (FMD), nitro-glycerine mediated dilation (NMD) and carotid intima media thickness (CIMT), blood pressure', 'cardiovascular risk factors', 'anti-inflammatory effects and improved FMD, FAE', 'cardiovascular disease markers', 'Cutaneous disease severity, inflammatory and lipid cardiovascular risk markers', 'hemodynamic parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1959568', 'cui_str': 'Fumarate Esters'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C1959568', 'cui_str': 'Fumarate Esters'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",65.0,0.0785267,This was paralleled by a significant decrease of hsCRP in the adalimumab group in comparison to the FAE group (v0:,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Holzer', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Austria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hoke', 'Affiliation': 'Department of Internal Medicine II, Division of Angiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sabeti-Sandor', 'Affiliation': 'Department of Internal Medicine II, Division of Angiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Perkmann', 'Affiliation': 'Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rauscher', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Austria.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Strassegger', 'Affiliation': 'Department of Dermatology, Donauspital, SMZ Ost, Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Radakovic', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Austria.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tanew', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Austria.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16635']
2384,32426888,Preschoolers exhibit greater on-task behavior following physically active lessons on the approximate number system.,"OBJECTIVE


To determine how the dual-task nature of incorporating physical activity with instructional activities immediately impacts acuity of the approximate number system and on-task behavior in preschoolers.
METHODS


Using a randomized within-participants repeated-measures crossover design, 51 children completed an approximate number system task before and after either 20-min of physically active instruction corresponding to 38% heart rate reserve (light-to-moderate intensity) or conventional sedentary instruction at corresponding to 21% heart rate reserve (very light intensity).
RESULTS


Findings revealed that preschool-aged children exhibited similar learning and greater on-task behavior following a single bout of physically active instruction relative to conventional sedentary instruction. Overall, preschoolers accrued 931.3 ± 8.2 more steps and an additional 9 minutes at or above light intensity activity during the physically active instruction.
CONCLUSION


Accordingly, these findings suggest that the dual-task nature of physically active learning does not compromise learning, reduces the need for redirecting off-task behavior, and ultimately allows children to avoid sedentary behavior in educational contexts.",2020,"RESULTS


Findings revealed that preschool-aged children exhibited similar learning and greater on-task behavior following a single bout of physically active instruction relative to conventional sedentary instruction.","['preschoolers', '51 children completed an']",['approximate number system task before and after either 20-min of physically active instruction corresponding to 38% heart rate reserve (light-to-moderate intensity) or conventional sedentary instruction at corresponding to 21% heart rate reserve (very light intensity'],['task behavior'],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439538', 'cui_str': 'Very light'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",51.0,0.058158,"RESULTS


Findings revealed that preschool-aged children exhibited similar learning and greater on-task behavior following a single bout of physically active instruction relative to conventional sedentary instruction.","[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'McGowan', 'Affiliation': 'Michigan State University, Department of Kinesiology, East Lansing, United States.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Ferguson', 'Affiliation': 'Michigan State University, Department of Kinesiology, East Lansing, United States.'}, {'ForeName': 'Hope K', 'Initials': 'HK', 'LastName': 'Gerde', 'Affiliation': 'Michigan State University, Human Development and Family Studies, East Lansing, United States.'}, {'ForeName': 'Karin A', 'Initials': 'KA', 'LastName': 'Pfeiffer', 'Affiliation': 'Michigan State University, Department of Kinesiology, East Lansing, United States.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Pontifex', 'Affiliation': 'Michigan State University, Department of Kinesiology, East Lansing, United States.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13727']
2385,23638904,Effect of a low glycaemic index diet in gestational diabetes mellitus on post-natal outcomes after 3 months of birth: a pilot follow-up study.,"A low glycaemic index (LGI) diet during pregnancy complicated by gestational diabetes mellitus (GDM) may offer benefits to the mother and infant pair beyond those during pregnancy. We aimed to investigate the effect of an LGI diet during pregnancy complicated with GDM on early post-natal outcomes. Fifty-eight women (age: 23-41 years; mean ± SD pre-pregnancy body mass index: 24.5 ± 5.6 kg m(-2) ) who had GDM and followed either an LGI diet (n = 33) or a conventional high-fibre diet (HF; n = 25) during pregnancy had a 75-g oral glucose tolerance test and blood lipid tests at 3 months post-partum. Anthropometric assessments were conducted for 55 mother-infant pairs. The glycaemic index of the antenatal diets differed modestly (mean ± SD: 46.8 ± 5.4 vs. 52.4 ± 4.4; P < 0.001), but there were no significant differences in any of the post-natal outcomes. In conclusion, an LGI diet during pregnancy complicated by GDM has outcomes similar to those of a conventional healthy diet. Adequately powered studies should explore the potential beneficial effects of LGI diet on risk factors for chronic disease.",2015,"The glycaemic index of the antenatal diets differed modestly (mean ± SD: 46.8 ± 5.4 vs. 52.4 ± 4.4; P < 0.001), but there were no significant differences in any of the post-natal outcomes.","['Fifty-eight women (age: 23-41 years; mean\u2009±\u2009SD pre-pregnancy body mass index: 24.5\u2009±\u20095.6\u2009kg\u2009m(-2) ) who had GDM and followed either an LGI diet (n\u2009=\u200933) or a', 'gestational diabetes mellitus on post-natal outcomes after 3 months of birth']","['conventional high-fibre diet (HF; n\u2009=\u200925) during pregnancy had a 75-g oral glucose tolerance test and blood lipid tests', 'low glycaemic index diet', 'low glycaemic index (LGI) diet', 'LGI diet']",['glycaemic index of the antenatal diets'],"[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0454729', 'cui_str': 'Natal (geographic location)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0301568', 'cui_str': 'High residue diet (finding)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]",58.0,0.0332779,"The glycaemic index of the antenatal diets differed modestly (mean ± SD: 46.8 ± 5.4 vs. 52.4 ± 4.4; P < 0.001), but there were no significant differences in any of the post-natal outcomes.","[{'ForeName': 'Jimmy Chun Yu', 'Initials': 'JC', 'LastName': 'Louie', 'Affiliation': 'School of Molecular Bioscience and Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tania P', 'Initials': 'TP', 'LastName': 'Markovic', 'Affiliation': 'School of Molecular Bioscience and Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Glynis P', 'Initials': 'GP', 'LastName': 'Ross', 'Affiliation': 'Department of Endocrinology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Foote', 'Affiliation': 'Department of Nutrition and Dietetics, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Jennie C', 'Initials': 'JC', 'LastName': 'Brand-Miller', 'Affiliation': 'School of Molecular Bioscience and Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Sydney, New South Wales, Australia.'}]",Maternal & child nutrition,['10.1111/mcn.12039']
2386,24253247,Outcomes by sex following treatment initiation with atazanavir plus ritonavir or efavirenz with abacavir/lamivudine or tenofovir/emtricitabine.,"BACKGROUND


We aimed to evaluate treatment responses to atazanavir plus ritonavir (ATV/r) or efavirenz (EFV) in initial antiretroviral regimens among women and men, and determine if treatment outcomes differ by sex.
METHODS


We performed a randomized trial of open-label ATV/r or EFV combined with abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) in 1857 human immunodeficiency virus type 1-infected, treatment-naive persons enrolled between September 2005 and November 2007 at 59 sites in the United States and Puerto Rico. Associations of sex with 3 primary study endpoints of time to virologic failure, safety, and tolerability events were analyzed using Cox proportional hazards models. Model-based population pharmacokinetic analysis was performed using nonlinear mixed effects modeling (NONMEM version VII).
RESULTS


Of 1857 participants, 322 were women. Women assigned to ATV/r had a higher risk of virologic failure with either nucleoside reverse transcriptase inhibitor backbone than women assigned to EFV, or men assigned to ATV/r. The effects of ATV/r and EFV upon safety and tolerability risk did not differ significantly by sex. With ABC/3TC, women had a significantly higher (32%) safety risk compared to men; with TDF/FTC, the safety risk was 20% larger for women compared to men, but not statistically significant. Women had slower ATV clearance and higher predose levels of ATV compared to men. Self-reported adherence did not differ significantly by sex.
CONCLUSIONS


This is the first randomized clinical trial to identify a significantly earlier time to virologic failure in women randomized to ATV/r compared to women randomized to EFV. This finding has important clinical implications given that boosted protease inhibitors are often favored over EFV in women of childbearing potential.
CLINICAL TRIALS REGISTRATION


NCT00118898.",2014,"Women assigned to ATV/r had a higher risk of virologic failure with either nucleoside reverse transcriptase inhibitor backbone than women assigned to EFV, or men assigned to ATV/r.","['1857 human immunodeficiency virus type 1-infected, treatment-naive persons enrolled between September 2005 and November 2007 at 59 sites in the United States and Puerto Rico', ' 322 were women', 'women of childbearing potential', '1857 participants', 'women and men']","['nucleoside reverse transcriptase inhibitor backbone', 'atazanavir plus ritonavir (ATV/r) or efavirenz (EFV', 'open-label ATV/r or EFV combined with abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC', 'EFV', 'atazanavir plus ritonavir or efavirenz with abacavir/lamivudine or tenofovir/emtricitabine', 'ATV/r and EFV']","['safety risk', 'safety and tolerability risk', 'virologic failure', 'slower ATV clearance and higher predose levels of ATV', 'Self-reported adherence', 'time to virologic failure, safety, and tolerability events']","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4324275', 'cui_str': 'Woman of childbearing potential'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0028621', 'cui_str': 'Nucleosides'}, {'cui': 'C4521921', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1613391', 'cui_str': 'abacavir / Lamivudine'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",322.0,0.0934302,"Women assigned to ATV/r had a higher risk of virologic failure with either nucleoside reverse transcriptase inhibitor backbone than women assigned to EFV, or men assigned to ATV/r.","[{'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine Division of Infectious Diseases, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Camlin', 'Initials': 'C', 'LastName': 'Tierney', 'Affiliation': ''}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Mollan', 'Affiliation': ''}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Venuto', 'Affiliation': ''}, {'ForeName': 'Chakra', 'Initials': 'C', 'LastName': 'Budhathoki', 'Affiliation': ''}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Gene D', 'Initials': 'GD', 'LastName': 'Morse', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sax', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Katzenstein', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Godfrey', 'Affiliation': ''}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Fischl', 'Affiliation': ''}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Daar', 'Affiliation': ''}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Collier', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/cit747']
2387,32426643,Decreasing Chronic Lung Disease Associated with Bubble CPAP Technology: Experience at Five Years.,"Introduction


Bubble continuous positive airway pressure (b CPAP) is associated with a decreased risk for chronic lung disease (CLD) in preterm neonates. This report examined the effectiveness of adopting  b CPAP to reduce respiratory complications and medication usage in a community hospital NICU.
Methods


The efficacy of  b CPAP was assessed by retrospective examination and comparison of 45 neonates who received  b CPAP and 87 neonates who received conventional ventilation only. Data on medication usage were also collected and analyzed.
Results


After introduction of the  b CPAP protocol, the median number of days on oxygen decreased in the  b CPAP group compared with the conventional ventilation only group (median = 33 days, IQR = 7.5-66 vs median = 0, IQR = 0-0;  P  < 0.001). The exposure to conventional ventilation decreased in the  b CPAP group compared with the conventional ventilation only group (median = 18 days, IQR = 5-42.5 vs median = 0, IQR = 0-7;  P  < 0.001). Postimplementation of  b CPAP revealed decreases in CLD from 26 (30%) in the conventional ventilation only group to 2 (4%) in the  b CPAP group ( P  = 0.002); there was also a significant decrease in the use of sedative medications in the  b CPAP group compared with the conventional ventilation only group (mean = 5.20 doses, SD = 31.97 vs mean = 1.43, SD = 9.98;  P < 0 .001).
Conclusion


The use of  b CPAP results in significant decreases in the use of conventional ventilation, the risk for CLD, and the need for sedative medication.",2020,"Postimplementation of  b CPAP revealed decreases in CLD from 26 (30%) in the conventional ventilation only group to 2 (4%) in the  b CPAP group ( P  = 0.002); there was also a significant decrease in the use of sedative medications in the  b CPAP group compared with the conventional ventilation only group (mean = 5.20 doses, SD = 31.97","['Decreasing Chronic Lung Disease Associated with Bubble CPAP Technology', '45 neonates who received  b CPAP and 87 neonates who received', 'preterm neonates']","['adopting  b CPAP', 'Introduction\n\n\nBubble continuous positive airway pressure (b CPAP', 'conventional ventilation only', 'conventional ventilation', 'b CPAP']","['median number of days on oxygen', 'conventional ventilation', 'CLD', 'sedative medications']","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.0789032,"Postimplementation of  b CPAP revealed decreases in CLD from 26 (30%) in the conventional ventilation only group to 2 (4%) in the  b CPAP group ( P  = 0.002); there was also a significant decrease in the use of sedative medications in the  b CPAP group compared with the conventional ventilation only group (mean = 5.20 doses, SD = 31.97","[{'ForeName': 'Tricia A', 'Initials': 'TA', 'LastName': 'Miller', 'Affiliation': 'Department of Pediatrics, Santa Barbara Cottage Hospital, Santa Barbara, Calif.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Santa Barbara Cottage Hospital, Santa Barbara, Calif.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Riddell', 'Affiliation': 'Department of Pediatrics, Santa Barbara Cottage Hospital, Santa Barbara, Calif.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Barkley', 'Affiliation': 'Department of Pediatrics, Santa Barbara Cottage Hospital, Santa Barbara, Calif.'}]",Pediatric quality & safety,['10.1097/pq9.0000000000000281']
2388,32426409,Risk of Deep Vein Thrombosis After Acute Achilles Tendon Rupture: A Secondary Analysis of a Randomized Controlled Trial Comparing Early Controlled Motion of the Ankle Versus Immobilization.,"Background


Immobilization of the ankle joint has been suggested as a key element in the pathogenesis leading to deep vein thrombosis (DVT).
Purpose


To investigate whether early controlled ankle motion (ECM) could reduce the incidence of DVT compared with immobilization (IM) in the treatment of acute Achilles tendon rupture.
Study Design


Randomized controlled trial; Level of evidence, 2.
Methods


Patients aged 18 to 70 years were eligible for inclusion, and treatment was nonoperative. The ECM group performed movements of the ankle 5 times a day from weeks 3 to 8 after rupture. The control group was immobilized for 8 weeks. The outcome measure was DVT diagnosed with color Doppler ultrasound for above- and below-knee DVT at 2 and 8 weeks. The Achilles tendon Total Rupture Score, the heel-rise work test, and the Copenhagen Achilles ultrasonographic Length Measurement were performed at 4-, 6-, and 12-month follow-up.
Results


A total of 189 patients were assessed for eligibility from February 2014 to December 2016. Of these, 130 were randomized: 68 patients were allocated to the ECM group and 62 to the IM group. All patients participated in follow-up at 8 weeks assessing for DVT. In total, 62 (47.7%) patients were diagnosed with DVT: 33 of 68 (48.5%) in the ECM group and 28 of 61 (46.8%) in the IM group ( P  = .84). DVT did not affect treatment outcomes at 4, 6, and 12 months. D-dimer had low sensitivity (71%) for detecting DVT.
Conclusion


We found that 1 in 2 patients presented with DVT in nonoperative treatment of acute Achilles tendon rupture. The ECM protocol revealed no benefit versus IM in reducing the incidence of DVT. DVT did not influence functional and patient-reported outcomes the first year after rupture. D-dimer seems an inappropriate test for detection of DVT in patients with acute Achilles tendon rupture.
Registration


NCT02015364 (ClinicalTrials.gov identifier).",2020,"DVT did not affect treatment outcomes at 4, 6, and 12 months.","['acute Achilles tendon rupture', 'patients with acute Achilles tendon rupture', 'After Acute Achilles Tendon Rupture', '130 were randomized: 68 patients', 'A total of 189 patients were assessed for eligibility from February 2014 to December 2016', 'Patients aged 18 to 70 years were eligible for inclusion, and treatment was nonoperative']","['immobilization (IM', 'ECM', 'DVT', 'early controlled ankle motion (ECM']","['Risk of Deep Vein Thrombosis', 'Achilles tendon Total Rupture Score, the heel-rise work test, and the Copenhagen Achilles ultrasonographic Length Measurement', 'incidence of DVT', 'DVT diagnosed with color Doppler ultrasound for above- and below-knee DVT']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0522507', 'cui_str': 'With color'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",189.0,0.118508,"DVT did not affect treatment outcomes at 4, 6, and 12 months.","[{'ForeName': 'Kristoffer Weisskirchner', 'Initials': 'KW', 'LastName': 'Barfod', 'Affiliation': 'Sports Orthopedic Research Center-Copenhagen, Arthroscopic Center, Department of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Emil Graakjær', 'Initials': 'EG', 'LastName': 'Nielsen', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital, Amager-Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Beth Hærsted', 'Initials': 'BH', 'LastName': 'Olsen', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital, Amager-Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Pablo Gustavo', 'Initials': 'PG', 'LastName': 'Vinicoff', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital, Amager-Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': 'Department of Orthopaedic Surgery, Clinical Orthopedic Research Amager-Hvidovre, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Holmich', 'Affiliation': 'Sports Orthopedic Research Center-Copenhagen, Arthroscopic Center, Department of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre, Hvidovre, Denmark.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967120915909']
2389,23800099,Double-blind cluster randomised controlled trial of wheat flour chapatti fortified with micronutrients on the status of vitamin A and iron in school-aged children in rural Bangladesh.,"Food fortification is a cost-effective and sustainable strategy to prevent or correct micronutrient deficiencies. A double-blind cluster (bari) randomised controlled trial was conducted in a rural community in Bangladesh to evaluate the impact of consumption of chapatti made of micronutrient-fortified wheat flour for 6 months by school-aged children on their vitamin A, haemoglobin and iron status. A total of 43 baris (group of households) were randomly selected. The baris were randomly assigned to either intervention or control group. The intervention group received wheat flour fortified with added micronutrients (including 66 mg hydrogen-reduced elemental iron and 3030 μg retinol equivalent as retinyl palmitate per kilogram of flour), while the control group received wheat flour without added micronutrients. A total of 352 children were enrolled in the trial, 203 in the intervention group and 149 in the control group. Analyses were carried out on children who completed the study (191 in the intervention group and 143 in the control group). Micronutrient-fortified wheat flour chapatti significantly increased serum retinol concentration at 6 months by 0.12 μmol L(-1) [95% confidence interval (CI): 0.06, 0.19; P < 0.01]. The odds of vitamin A deficiency was significantly lower for children in the intervention group at 3 months [odds ratio (OR) = 0.26; 95% confidence interval (CI): 0.07, 0.89; P < 0.05] and 6 months (OR = 0.21; 95% CI: 0.06, 0.68; P < 0.01). No demonstrable effect of fortified chapatti consumption on iron status, haemoglobin levels or anaemia was observed. Consumption of fortified chapattis demonstrated a significant improvement in the vitamin A status, but not in iron, haemoglobin or anaemia status.",2015,Analyses were carried out on children who completed the study (191 in the intervention group and 143 in the control group).,"['school-aged children in rural Bangladesh', 'rural community in Bangladesh', '352 children were enrolled in the trial, 203 in the intervention group and 149 in the control group', 'A total of 43 baris (group of households', 'for 6 months by school-aged children on their vitamin A, haemoglobin and iron status']","['Micronutrient-fortified wheat flour chapatti', 'wheat flour fortified with added micronutrients (including 66\u2009mg hydrogen-reduced elemental iron and 3030\u2009μg retinol equivalent as retinyl palmitate per kilogram of flour), while the control group received wheat flour without added micronutrients', 'micronutrient-fortified wheat flour', 'vitamin A and iron', 'wheat flour chapatti fortified with micronutrients', 'Food fortification']","['fortified chapatti consumption on iron status, haemoglobin levels or anaemia', 'odds of vitamin A deficiency', 'serum retinol concentration', 'iron, haemoglobin or anaemia status']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour (substance)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0556581', 'cui_str': 'Retinol equivalents (qualifier value)'}, {'cui': 'C0073115', 'cui_str': 'retinyl palmitate'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0042842', 'cui_str': 'Vitamin A Deficiency'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",352.0,0.366962,Analyses were carried out on children who completed the study (191 in the intervention group and 143 in the control group).,"[{'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Diseases Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrhoeal Diseases Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Faiz', 'Initials': 'F', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrhoeal Diseases Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad S', 'Initials': 'MS', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Diseases Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad A', 'Initials': 'MA', 'LastName': 'Wahed', 'Affiliation': 'International Centre for Diarrhoeal Diseases Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Sack', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12065']
2390,32421612,Recovery from recurrent depression: Randomized controlled trial of the efficacy of mindfulness-based compassionate living compared with treatment-as-usual on depressive symptoms and its consolidation at longer term follow-up.,"INTRODUCTION


Mindfulness-Based Cognitive Therapy (MBCT) has been shown to reduce depressive symptoms in patients with recurrent or chronic depression. However, sequential, follow-up interventions are needed to further improve outcome for this group of patients. One possibility is to cultivate mechanisms thought to support recovery from depression, such as (self-)compassion. The current study examined the efficacy of mindfulness-based compassionate living (MBCL) in recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up.
METHODS


Part one is a randomized controlled trial (RCT) comparing MBCL in addition to treatment as usual (TAU) with TAU alone. The primary outcome measure was severity of depressive symptoms. Possible mediators and moderators of treatment outcome were examined. Part two is an uncontrolled study of both intervention- and control group on the consolidation of treatment effect of MBCL over the course of a 6-months follow-up period.
RESULTS


Patients were recruited between July 2013 and December 2014 (N = 122). MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61). The results at 6-months follow-up showed a continued improvement of depressive symptoms.
LIMITATIONS


As MBCL was not compared with an active control condition, we have little information about the possible effectiveness of non-specific factors.
CONCLUSION


MBCL appears to be effective in reducing depressive symptoms in a population suffering from severe, prolonged, recurrent depressive symptoms. To optimise the (sequential) treatment trajectory, replication of the study in a prospective sequential trial is needed. Registered at ClinicalTrials.gov:NCT02059200.",2020,"MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61).","['patients with recurrent or chronic depression', 'recurrent depression', 'recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up', 'Patients were recruited between July 2013 and December 2014 (N\xa0=\xa0122']","['MBCL', 'TAU', 'mindfulness-based compassionate living (MBCL', 'intervention', 'Mindfulness-Based Cognitive Therapy (MBCT', 'mindfulness-based compassionate living compared with treatment-as-usual']","['depressive symptoms', 'severity of depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0570495,"MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61).","[{'ForeName': 'Rhoda', 'Initials': 'R', 'LastName': 'Schuling', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands. Electronic address: rhoda.schuling@radboudumc.nl.'}, {'ForeName': 'Marloes J', 'Initials': 'MJ', 'LastName': 'Huijbers', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Hiske', 'Initials': 'H', 'LastName': 'van Ravesteijn', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Health Technology Assessment, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cillessen', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kuyken', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Anne E M', 'Initials': 'AEM', 'LastName': 'Speckens', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.182']
2391,31356483,Effect of Vestibular Exercises Associated With Repositioning Maneuvers in Patients With Benign Paroxysmal Positional Vertigo: A Randomized Controlled Clinical Trial.,": In addition to positional vertigo, it is quite common for patients with benign paroxysmal positional vertigo (BPPV) to present complaints associated with balance problems and a feeling of dizziness even after repositioning maneuvers.
OBJECTIVE


It was to evaluate the additional effects of vestibular rehabilitation exercises as a therapeutic resource in the treatment of BPPV, to improve symptoms and reduce recurrence.
STUDY DESIGN


This was an experimental, prospective, randomized, controlled study.
SETTING


Instituto Brasiliense de Otorrinolaringologia (IBORL) from August 2016 to September 2017.
PATIENTS


Thirty-two individuals, both men and women, over 18 years of age with BPPV.
INTERVENTION


They were randomly assigned to two groups: the control group (n = 15) performing only the maneuver technique as treatment and the experimental group (n = 17) performing the maneuvers and vestibular rehabilitation exercises. Patients underwent treatment and responded to the dizziness handicap inventory (DHI) and visual analog scale (VAS) questionnaires for comparison between groups. Participants were followed up for 6 months to observe recurrence of symptoms.
MAIN OUTCOME MEASURES


To investigate the additional effects of vestibular exercises in the treatment of BPPV.
RESULTS


The experimental group had a lower level of dizziness in the posttreatment period (p < 0.05) and a lower incidence of recurrences (p = 0.038) than the control group.
CONCLUSIONS


Vestibular exercises performed after repositioning treatments for BPPV increased the overall efficacy of treatment by improving symptoms with a lower rate of recurrence.",2019,"The experimental group had a lower level of dizziness in the posttreatment period (p < 0.05) and a lower incidence of recurrences (p = 0.038) than the control group.
","['Instituto Brasiliense de Otorrinolaringologia (IBORL) from August 2016 to September 2017', 'Thirty-two individuals, both men and women, over 18 years of age with BPPV', 'patients with benign paroxysmal positional vertigo (BPPV', 'Patients With Benign Paroxysmal Positional Vertigo']","['vestibular rehabilitation exercises', 'vestibular exercises', 'Vestibular Exercises', 'control group (n\u200a=\u200a15) performing only the maneuver technique as treatment and the experimental group (n\u200a=\u200a17) performing the maneuvers and vestibular rehabilitation exercises']","['level of dizziness', 'dizziness handicap inventory (DHI) and visual analog scale (VAS) questionnaires', 'recurrence of symptoms', 'incidence of recurrences']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",32.0,0.0502325,"The experimental group had a lower level of dizziness in the posttreatment period (p < 0.05) and a lower incidence of recurrences (p = 0.038) than the control group.
","[{'ForeName': 'Daniele Leite', 'Initials': 'DL', 'LastName': 'Rodrigues', 'Affiliation': 'Health Science, University of Brasília - L2 Sul.'}, {'ForeName': 'Alleluia Lima Losno', 'Initials': 'ALL', 'LastName': 'Ledesma', 'Affiliation': 'Health Science, University of Brasília - L2 Sul.'}, {'ForeName': 'Carlos Augusto', 'Initials': 'CA', 'LastName': 'Pires de Oliveira', 'Affiliation': 'Health Science, University of Brasília - L2 Sul.'}, {'ForeName': 'Fayez', 'Initials': 'F', 'LastName': 'Bahmad', 'Affiliation': 'Health Science, University of Brasília - L2 Sul.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002324']
2392,24028173,Promoting positive attitudes to breastfeeding: the development and evaluation of a theory-based intervention with school children involving a cluster randomised controlled trial.,"The objective of this study was to design, implement and evaluate an intervention based on the theory of planned behaviour (TPB) to enhance young peoples' motivations to breastfeed/support a partner to breastfeed. Six semi-structured focus groups were first conducted with 48 13-14-year-olds from two schools in Northern Ireland. The salient beliefs elicited were subsequently used to design a TPB-based questionnaire that was then administered to 2021 13-14-year-old pupils (852 males; 1169 females) from 36 post-primary schools to identify the most important determinants of breastfeeding. The results were used to inform the design and implementation of an intervention package that was subsequently evaluated using a cluster randomised controlled trial involving 44 randomly selected schools across Northern Ireland. Questionnaires were administered to 18 intervention and 26 control schools at baseline and again at 1 and 6 months post-intervention to evaluate its effectiveness. Multi-level modelling was employed to analyse the data. The results revealed significant effects on women's intention to breastfeed, β = 0.208, t(1275) = 2.715, P = 0.007; attitudes, β = 0.223, t(1275) = 4.655, P < 0.001; moral attitudes, β = 0.231, t(1275) = 4.211, P < 0.001; subjective norm, β = 0.118, t(1275) = 2.521, P = 0.012; and knowledge, β = 0.109, d.f. (1275) = 7.843, P < 0.001. However, for men, the results revealed significant effects on only the construct of knowledge, β = 0.104, t(541) = 4.345, P < 0.001.The research has provided evidence to support the need for breastfeeding education in schools and has shown how a theoretical framework may be used to inform the design and evaluation of a health behaviour intervention.",2015,"The results revealed significant effects on women's intention to breastfeed, β = 0.208, t(1275) = 2.715, P = 0.007; attitudes, β = 0.223, t(1275) = 4.655, P < 0.001; moral attitudes, β = 0.231, t(1275) = 4.211, P < 0.001; subjective norm, β = 0.118, t(1275) = 2.521, P = 0.012; and knowledge, β = 0.109, d.f.","['44 randomly selected schools across Northern Ireland', '2021 13-14-year-old pupils (852 males; 1169 females) from 36 post-primary schools', '48 13-14-year-olds from two schools in Northern Ireland']",['planned behaviour (TPB'],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}]",[],44.0,0.0473555,"The results revealed significant effects on women's intention to breastfeed, β = 0.208, t(1275) = 2.715, P = 0.007; attitudes, β = 0.223, t(1275) = 4.655, P < 0.001; moral attitudes, β = 0.231, t(1275) = 4.211, P < 0.001; subjective norm, β = 0.118, t(1275) = 2.521, P = 0.012; and knowledge, β = 0.109, d.f.","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Giles', 'Affiliation': 'School of Psychology, University of Ulster, Coleraine, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Millar', 'Affiliation': 'UKCRC Centre of Excellence for Public Health NI, Institute of Clinical Sciences, School of Medicine, Dentistry and Biomedical Sciences, Queens University, Belfast, UK.'}, {'ForeName': 'Cherie', 'Initials': 'C', 'LastName': 'Armour', 'Affiliation': 'School of Psychology, University of Ulster, Coleraine, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'McClenahan', 'Affiliation': 'School of Psychology, University of Ulster, Coleraine, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mallett', 'Affiliation': 'School of Psychology, University of Ulster, Coleraine, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stewart-Knox', 'Affiliation': 'School of Biomedical Sciences, University of Ulster, Coleraine, UK.'}]",Maternal & child nutrition,['10.1111/mcn.12079']
2393,24022589,Interaction of fatty acid genotype and diet on changes in colonic fatty acids in a Mediterranean diet intervention study.,"A Mediterranean diet increases intakes of n-3 and n-9 fatty acids and lowers intake of n-6 fatty acids. This can impact colon cancer risk as n-6 fatty acids are metabolized to proinflammatory eicosanoids. The purpose of this study was to evaluate interactions of polymorphisms in the fatty acid desaturase (FADS) genes, FADS1 and FADS2, and changes in diet on fatty acid concentrations in serum and colon. A total of 108 individuals at increased risk of colon cancer were randomized to either a Mediterranean or a Healthy Eating diet. Fatty acids were measured in both serum and colonic mucosa at baseline and after six months. Each individual was genotyped for four single-nucleotide polymorphisms in the FADS gene cluster. Linear regression was used to evaluate the effects of diet, genotype, and the diet by genotype interaction on fatty acid concentrations in serum and colon. Genetic variation in the FADS genes was strongly associated with baseline serum arachidonic acid (n-6) but serum eicosapentaenoic acid (n-3) and colonic fatty acid concentrations were not significantly associated with genotype. After intervention, there was a significant diet by genotype interaction for arachidonic acid concentrations in colon. Subjects who had all major alleles for FADS1/2 and were following a Mediterranean diet had 16% lower arachidonic acid concentrations in the colon after six months of intervention than subjects following the Healthy Eating diet. These results indicate that FADS genotype could modify the effects of changes in dietary fat intakes on arachidonic acid concentrations in the colon.",2013,Genetic variation in the FADS genes was strongly associated with baseline serum arachidonic acid (n-6) but serum eicosapentaenoic acid (n-3) and colonic fatty acid concentrations were not significantly associated with genotype.,"['Subjects who had all major alleles for FADS1/2 and were following a', '108 individuals at increased risk of colon cancer']","['Mediterranean or a Healthy Eating diet', 'fatty acid genotype and diet', 'Mediterranean diet']","['baseline serum arachidonic acid (n-6) but serum eicosapentaenoic acid (n-3) and colonic fatty acid concentrations', 'arachidonic acid concentrations', 'Fatty acids']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",108.0,0.0162235,Genetic variation in the FADS genes was strongly associated with baseline serum arachidonic acid (n-6) but serum eicosapentaenoic acid (n-3) and colonic fatty acid concentrations were not significantly associated with genotype.,"[{'ForeName': 'Shannon R', 'Initials': 'SR', 'LastName': 'Porenta', 'Affiliation': 'University of Michigan, 1500 E. Medical Center Drive, Room 2150 Cancer Center, Ann Arbor, MI 48109-5930. zoralong@umich.edu.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Gruber', 'Affiliation': ''}, {'ForeName': 'Bhramar', 'Initials': 'B', 'LastName': 'Mukherjee', 'Affiliation': ''}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Baylin', 'Affiliation': ''}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Zora', 'Initials': 'Z', 'LastName': 'Djuric', 'Affiliation': ''}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-13-0131']
2394,23996977,Baseline predictors of missed visits in the Look AHEAD study.,"OBJECTIVE


To identify baseline attributes associated with consecutively missed data collection visits during the first 48 months of Look AHEAD—a randomized, controlled trial in 5,145 overweight/obese adults with type 2 diabetes designed to determine the long-term health benefits of weight loss achieved by lifestyle change.
DESIGN AND METHODS


The analyzed sample consisted of 5,016 participants who were alive at month 48 and enrolled at Look AHEAD sites. Demographic, baseline behavior, psychosocial factors, and treatment randomization were included as predictors of missed consecutive visits in proportional hazard models.
RESULTS


In multivariate Cox proportional hazard models, baseline attributes of participants who missed consecutive visits (n 5 222) included: younger age (hazard ratio [HR] 1.18 per 5 years younger; 95% confidence Interval 1.05, 1.30), higher depression score (HR 1.04; 1.01, 1.06), non-married status (HR 1.37; 1.04, 1.82), never self-weighing prior to enrollment (HR 2.01; 1.25, 3.23), and randomization to minimal vs. intensive lifestyle intervention (HR 1.46; 1.11, 1.91).
CONCLUSIONS


Younger age, symptoms of depression, non-married status, never self-weighing, and randomization to minimal intervention were associated with a higher likelihood of missing consecutive data collection visits, even in a high-retention trial like Look AHEAD. Whether modifications to screening or retention efforts targeted to these attributes might enhance long-term retention in behavioral trials requires further investigation.",2014,Whether modifications to screening or retention efforts targeted to these attributes might enhance long-term retention in behavioral trials requires further investigation.,"['5,016 participants who were alive at month 48 and enrolled at Look AHEAD sites', '5,145 overweight/obese adults with type 2 diabetes']",[],"['higher depression score', 'weight loss']","[{'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",5145.0,0.138217,Whether modifications to screening or retention efforts targeted to these attributes might enhance long-term retention in behavioral trials requires further investigation.,"[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Fitzpatrick', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jeffery', 'Affiliation': ''}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Cathy C', 'Initials': 'CC', 'LastName': 'Roche', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Van Dorsten', 'Affiliation': ''}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Gee', 'Affiliation': ''}, {'ForeName': 'Ruby Ann', 'Initials': 'RA', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Charleston', 'Affiliation': ''}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Dotson', 'Affiliation': ''}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Walkup', 'Affiliation': ''}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Hill-Briggs', 'Affiliation': ''}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Brancati', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1002/oby.20613']
2395,23592741,Relationships between serum and colon concentrations of carotenoids and fatty acids in randomized dietary intervention trial.,"Little is known about the effect of preventive diets on colonic nutrient concentrations. This study randomized 120 persons at increased risk of colon cancer to a Mediterranean versus a Healthy Eating diet for six months. The former targeted increases in whole grains, fruits, vegetables, monounsaturated, and n3 fats. The Healthy Eating diet was based on Healthy People 2010 recommendations. At baseline, dietary fat and carotenoid intakes were poorly associated (Spearman ρ < 0.4) with serum and colon concentrations. Strong associations were observed between serum and colon measurements of β-cryptoxanthin (ρ = 0.58; P < 0.001), α-carotene (ρ = 0.48; P < 0.001), and β-carotene (ρ = 0.45; P < 0.001). After six months, the Healthy Eating intervention increased serum lutein, β-, and α-carotene significantly (P < 0.05). In the Mediterranean arm, the significant increases were in serum lutein, β-cryptoxanthin, β-carotene, monounsaturated, and n3 fats. A significant group-by-time interaction (P = 0.03) was obtained for monounsaturated fats. Colonic increases in carotenoids and n3 fats were significant only in Healthy Eating arm, whereas the group-by-time interaction was significant for β-carotene (P = 0.02) and α-carotene (P = 0.03). Changes in colon concentrations were not significantly associated with reported dietary changes. Changes in colon and serum concentrations were strongly associated for β-cryptoxanthin (ρ = 0.56; P < 0.001) and α-carotene (ρ = 0.40; P < 0.001). The associations between colonic and serum concentrations suggest the potential use of using serum concentration as a target in dietary interventions aimed at reducing colon cancer risk.",2013,"In the Mediterranean arm, the significant increases were in serum lutein, β-cryptoxanthin, β-carotene, monounsaturated, and n3 fats.",['120 persons at increased risk of colon cancer to a Mediterranean versus a Healthy Eating diet for six months'],[],"['Changes in colon and serum concentrations', 'Changes in colon concentrations', 'serum lutein, β-, and α-carotene', 'dietary fat and carotenoid intakes', 'whole grains, fruits, vegetables, monounsaturated, and n3 fats', 'Colonic increases in carotenoids and n3 fats', 'serum lutein, β-cryptoxanthin, β-carotene, monounsaturated, and n3 fats', 'α-carotene', 'serum and colon measurements of β-cryptoxanthin']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]",[],"[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}, {'cui': 'C0012171', 'cui_str': 'Dietary Fats'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3850081', 'cui_str': 'Beta-Caroten-3-ol'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",120.0,0.0181622,"In the Mediterranean arm, the significant increases were in serum lutein, β-cryptoxanthin, β-carotene, monounsaturated, and n3 fats.","[{'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical Center, 1018 Fuller St., Ann Arbor, MI 48104, USA. anandas@med.umich.edu'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Mack T', 'Initials': 'MT', 'LastName': 'Ruffin', 'Affiliation': ''}, {'ForeName': 'Danielle K', 'Initials': 'DK', 'LastName': 'Turgeon', 'Affiliation': ''}, {'ForeName': 'Dean E', 'Initials': 'DE', 'LastName': 'Brenner', 'Affiliation': ''}, {'ForeName': 'Elkhansa', 'Initials': 'E', 'LastName': 'Sidahmed', 'Affiliation': ''}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Rapai', 'Affiliation': ''}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Cornellier', 'Affiliation': ''}, {'ForeName': 'Zora', 'Initials': 'Z', 'LastName': 'Djuric', 'Affiliation': ''}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-13-0019']
2396,32421411,"Re: Effect of Tadalafil 5 mg on Post-Micturition Dribble in Men with Lower Urinary Tract Symptoms: A Multicentre, Double-Blind, Randomized, Placebo-Controlled Trial.",,2020,,['Men with Lower Urinary Tract Symptoms'],"['Tadalafil', 'Placebo']",[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.61342,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001118.04']
2397,32427228,Squeeze bottle versus syringe nasal saline irrigation for persistent allergic rhinitis - a randomized controlled trial.,"BACKGROUND


Nasal irrigation is widely used as an adjunctive treatment for allergic rhinitis. There is little evidence regarding the efficacy of the devices used in this procedure. The objective of this study was to evaluate the efficacy of the squeeze bottle nasal saline irrigation in persistent allergic rhinitis patients compared with a syringe.
METHODOLOGY


We included patients between 18- and 60-years old presenting with persistent allergic rhinitis. All patients were instructed to perform nasal irrigation twice daily for four weeks. The patients were randomly assigned to use either the squeeze bottle nasal irrigation or a syringe for nasal irrigation. Symptoms score, physical examination results, satisfaction scores and adverse events were collected.
RESULTS


There were 116 patients enrolled in the study, 58 of whom used the squeeze bottle nasal irrigation system and 58 of whom used a syringe. During a four-week follow-up, improvements in patients' nasal symptom scores for rhinitis symptoms were significantly greater in the group treated with the squeeze bottle. However, the physical examination score was no statistically significant difference. No adverse events were reported. The overall satisfaction scores for both devices were excellent.
CONCLUSIONS


This study supports the regular use of nasal irrigation with a positive-pressure device, particularly a squeeze bottle, as an effective adjunctive treatment for allergic rhinitis. It is effective for reducing allergic rhinitis symptoms and can be used by patients with good compliance and minimal side effects.",2020,"During a four-week follow-up, improvements in patients' nasal symptom scores for rhinitis symptoms were significantly greater in the group treated with the squeeze bottle.","['allergic rhinitis', '116 patients enrolled in the study, 58 of whom used the squeeze bottle nasal irrigation system and 58 of whom used a syringe', 'persistent allergic rhinitis patients', 'patients between 18- and 60-years old presenting with persistent allergic rhinitis']","['squeeze bottle nasal irrigation or a syringe for nasal irrigation', 'Squeeze bottle versus syringe nasal saline irrigation', 'squeeze bottle nasal saline irrigation']","[""patients' nasal symptom scores for rhinitis symptoms"", 'allergic rhinitis symptoms', 'adverse events', 'physical examination score', 'Symptoms score, physical examination results, satisfaction scores and adverse events', 'overall satisfaction scores']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",116.0,0.0416316,"During a four-week follow-up, improvements in patients' nasal symptom scores for rhinitis symptoms were significantly greater in the group treated with the squeeze bottle.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Piromchai', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kasemsiri', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Reechaipichitkul', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}]",Rhinology,['10.4193/Rhin19.308']
2398,23556466,Early prenatal food supplementation ameliorates the negative association of maternal stress with birth size in a randomised trial.,"Low birthweight increases the risk of infant mortality, morbidity and poor development. Maternal nutrition and stress influence birth size, but their combined effect is not known. We hypothesised that an early-invitation time to start a prenatal food supplementation programme could reduce the negative influence of prenatal maternal stress on birth size, and that effect would differ by infant sex. A cohort of 1041 pregnant women, who had delivered an infant, June 2003-March 2004, was sampled from among 3267 in the randomised controlled trial, Maternal Infant Nutritional Interventions Matlab, conducted in Matlab, Bangladesh. At 8 weeks gestation, women were randomly assigned an invitation to start food supplements (2.5 MJ d(-1) ; 6 days a week) either early (∼9 weeks gestation; early-invitation group) or at usual start time for the governmental programme (∼20 weeks gestation; usual-invitation group). Morning concentration of cortisol was measured from one saliva sample/woman at 28-32 weeks gestation to assess stress. Birth-size measurements for 90% of infants were collected within 4 days of birth. In a general linear model, there was an interaction between invitation time to start the food supplementation programme and cortisol with birthweight, length and head circumference of male infants, but not female infants. Among the usual-invitation group only, male infants whose mothers had higher prenatal cortisol weighed less than those whose mothers had lower prenatal cortisol. Prenatal food supplementation programmes that begin first trimester may support greater birth size of male infants despite high maternal stress where low birthweight is a public health concern.",2015,Prenatal food supplementation programmes that begin first trimester may support greater birth size of male infants despite high maternal stress where low birthweight is a public health concern.,"['1041 pregnant women, who had delivered an infant, June 2003-March', 'male infants, but not female infants', '2004, was sampled from among 3267 in the randomised controlled trial, Maternal Infant Nutritional Interventions Matlab, conducted in Matlab, Bangladesh']",[],"['Birth-size measurements', 'prenatal maternal stress on birth size', 'risk of infant mortality, morbidity and poor development', 'Maternal nutrition and stress influence birth size', 'Morning concentration of cortisol', 'prenatal cortisol']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]",[],"[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021278', 'cui_str': 'Infant Mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",1041.0,0.205781,Prenatal food supplementation programmes that begin first trimester may support greater birth size of male infants despite high maternal stress where low birthweight is a public health concern.,"[{'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Frith', 'Affiliation': 'School of Health Sciences and Human Performance, Ithaca College, Ithaca, New York, USA.'}, {'ForeName': 'Ruchira T', 'Initials': 'RT', 'LastName': 'Naved', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), Dhaka, Bangladesh.'}, {'ForeName': 'Lars Ake', 'Initials': 'LA', 'LastName': 'Persson', 'Affiliation': ""Women's and Children's Health, International Maternal and Child Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Frongillo', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, University of South Carolina, Columbia, South Carolina, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12047']
2399,32427120,The effects of omega-3 on the sleep quality of patients with uremic pruritus undergoing hemodialysis: a randomized crossover study.,"Objectives Information on sleep quality and its effective factors in the patients undergoing hemodialysis are important factors in future planning for improving sleep quality and ultimately the quality of life in these patients. The present study investigated the effect of omega-3 on the sleep quality of hemodialysis patients. Methods The 52 hemodialysis patients were randomized into two groups and underwent two different treatment modes (A and B). The first group was given omega-3 and cetirizine and the second group only received cetirizine for six weeks. After one week wash out, the study was followed by crossover treatment in both groups for six weeks. Sleep quality and pruritus severity were evaluated in patients before the intervention and at the end of each treatment period using the Pittsburgh Sleep Quality Index and the Yosipovitch Itch Questionnaire. The collected data was analyzed using repeated measures ANOVA and the Pearson correlation coefficient. Results The results of the study showed that majority of the patients (94.2%) had poor sleep quality (sleep score > 5 based on the questionnaire) and 5.8% of the patients had favorable sleep quality (sleep score < 5). Repeated measures ANOVA showed that sleep quality scores were different in two groups in phases 0, I and II (p <0.001). Conclusions Sleep quality improved in both modes but more improvement was observed in mode A. Therefore, omega-3 fatty acids can be used as a suitable method for improving sleep quality in hemodialysis patients.",2020,"Repeated measures ANOVA showed that sleep quality scores were different in two groups in phases 0, I and II (p <0.001).","['patients with uremic pruritus undergoing hemodialysis', 'patients undergoing hemodialysis', 'hemodialysis patients', '52 hemodialysis patients']","['omega-3 and cetirizine', 'omega-3', 'omega-3 fatty acids', 'cetirizine']","['Pittsburgh Sleep Quality Index and the Yosipovitch Itch Questionnaire', 'poor sleep quality (sleep score', 'sleep quality scores', 'Conclusions Sleep quality', 'Sleep quality and pruritus severity', 'favorable sleep quality', 'sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262019', 'cui_str': 'Uremic pruritus'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0055147', 'cui_str': 'Cetirizine'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",52.0,0.0115676,"Repeated measures ANOVA showed that sleep quality scores were different in two groups in phases 0, I and II (p <0.001).","[{'ForeName': 'Mansoureh', 'Initials': 'M', 'LastName': 'Heydarbaki', 'Affiliation': 'Student Research Committee, School of Nursing & Midwifery, Shahroud University of Medical Sciences, Shahroud, Islamic Republic of Iran.'}, {'ForeName': 'Monireh', 'Initials': 'M', 'LastName': 'Amerian', 'Affiliation': 'Clinical Research Development Unit, Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Islamic Republic of Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbasi', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Islamic Republic of Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Amanpour', 'Affiliation': 'Clinical Research Development Unit, Bahar Hospital, Shahroud University of Medical Sciences, Shahroud, Islamic Republic of Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mohammadpourhodki', 'Affiliation': 'Kashmar Center of Higher Health Education, Mashhad University of Medical Sciences, Mashhad, Islamic Republic of Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ebrahimi', 'Affiliation': 'Randomized Controlled Trial Research Center, Shahroud University of Medical Sciences, Shahroud, Islamic Republic of Iran.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0081']
2400,32427122,"The effect of practicing yoga during pregnancy on labor stages length, anxiety and pain: a randomized controlled trial.","Background Anxiety and fear of labor pain has led to elevated cesarean section rate in some countries. This study was conducted to investigate the effect of yoga in pregnancy on anxiety, labor pain and length of labor stages. Methods This clinical trial study was performed on 84 nulliparous women who were at least 18 years old and were randomly divided into two groups of yoga and control groups. Pregnancy Yoga Program consisting of 6 60-min training sessions was started every 2 weeks from week 26 of pregnancy and continued until 37 weeks of gestation. Anxiety severity at maternal admission to labor was measured by the Spielbergers State-Trait Anxiety Inventory, and labor pain was measured by Visual Analogue Scale (VAS) at dilatation (4-5 cm) and 2 h after the first measurement. Data were analyzed using Chi-Square and t-test. Results Intervention group reported less pain at dilatation (4-5 cm) (p=0.001) and 2 h after the first measurement (p=0.001) than the control group. Stat anxiety was also lower in intervention group than the control group (p=0.003) at the entrance to labor room. Subjects in the control group required more induction compared to intervention group (p=0.003). Women in intervention group experienced shorter duration of the first phase of the labor than the control group (p=0.002). Also, the total duration of two stages of labor was shorter in intervention group than the control group (p=0.003). Conclusions Practicing yoga during pregnancy may reduce women's anxiety during labor; shorten labor stages, and lower labor pain.",2020,Stat anxiety was also lower in intervention group than the control group (p=0.003) at the entrance to labor room.,['84 nulliparous women who were at least 18 years old'],['practicing yoga'],"['Spielbergers State-Trait Anxiety Inventory, and labor pain', 'Stat anxiety', 'total duration of two stages of labor', 'cesarean section rate', 'Visual Analogue Scale (VAS) at dilatation', 'labor stages length, anxiety and pain', ' Anxiety and fear of labor pain', 'Anxiety severity at maternal admission to labor', 'pain at dilatation', 'shorter duration of the first phase of the labor', 'anxiety, labor pain and length of labor stages']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424139', 'cui_str': 'Anxiety and fear'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}]",84.0,0.0487579,Stat anxiety was also lower in intervention group than the control group (p=0.003) at the entrance to labor room.,"[{'ForeName': 'Ellahe', 'Initials': 'E', 'LastName': 'Mohyadin', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Ghorashi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Geriatric Care Research Center, Rafsanjan University of Medical Sciences, Parastar Street, Rafsanjan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Molamomanaei', 'Affiliation': 'Sport Biomechanics, Rafsanjan, Iran.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0291']
2401,32421353,Intrapleural Fibrinolytic Therapy versus Early Medical Thoracoscopy for Treatment of Pleural Infection: Randomized Clinical Trial.,"RATIONALE


Pleural infection is a frequent diagnosis encountered in clinical practice associated with high morbidity and mortality. Limited evidence exists regarding the optimal treatment. Although both early medical thoracoscopy (MT) and tube thoracostomy with intrapleural instillation of tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) are acceptable treatment for patients with complicated pleural infection, there is a lack of comparative data between these modes of management.
OBJECTIVES


The aim of this study was to compare the safety and efficacy of early MT versus intrapleural fibrinolytic therapy (IPFT) in selected patients with multiloculated pleural infection and empyema.
METHODS


This was a prospective multicenter randomized control trial of patients who underwent MT or IPFT for pleural infection. The primary outcome was the length of hospital stay following either intervention. Secondary outcomes included total length of hospital stay, treatment failure, 30-day mortality and adverse events.
RESULTS


32 patients with pleural infection were included in the study. The median length of stay following intervention was 4 days in IPFT arm as compared to 2 days in MT (p=0.026). The total length of hospital stay was 6 days in IPFT arm and 3.5 days in MT arm (p=0.12). There was no difference in treatment failure, mortality or adverse events between treatment groups, and no serious complications related to either interventions were recorded.
CONCLUSION


Medical thoracoscopy when used early in the course of a complicated parapneumonic effusion or empyema is safe and might shorten hospital stay in selected patients with as compared with IPFT therapy. Multicenter trial with larger sample size is needed to confirm such findings. Clinical trial registered with ClinicalTrials.gov (NCT02973139).",2020,"There was no difference in treatment failure, mortality or adverse events between treatment groups, and no serious complications related to either interventions were recorded.
","['patients with complicated pleural infection', 'selected patients with multiloculated pleural infection and empyema', 'Pleural Infection', '32 patients with pleural infection', 'patients who underwent MT or IPFT for pleural infection']","['Intrapleural Fibrinolytic Therapy versus Early Medical Thoracoscopy', 'IPFT therapy', 'Medical thoracoscopy', 'medical thoracoscopy (MT) and tube thoracostomy with intrapleural instillation of tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase', 'early MT versus intrapleural fibrinolytic therapy (IPFT']","['treatment failure, mortality or adverse events', 'median length of stay', 'total length of hospital stay, treatment failure, 30-day mortality and adverse events', 'length of hospital stay', 'safety and efficacy', 'total length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0014009', 'cui_str': 'Empyema'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0595451', 'cui_str': 'Intrapleural route'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}]","[{'cui': 'C0595451', 'cui_str': 'Intrapleural route'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0189476', 'cui_str': 'Insertion of pleural tube drain'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1135662', 'cui_str': 'Dornase Alfa'}, {'cui': 'C0011522', 'cui_str': 'Deoxyribonucleases'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",32.0,0.0949974,"There was no difference in treatment failure, mortality or adverse events between treatment groups, and no serious complications related to either interventions were recorded.
","[{'ForeName': 'Fayez', 'Initials': 'F', 'LastName': 'Kheir', 'Affiliation': 'Tulane University, 5783, Pulmonary Diseases, Critical Care and Environmental Medicine, New Orleans, Louisiana, United States.'}, {'ForeName': 'Sanket', 'Initials': 'S', 'LastName': 'Thakore', 'Affiliation': 'Tulane University Hospital and Clinic, 21815, Pulmonary Diseases, Critical Care and Environmental Medicine, New Orleans, Louisiana, United States.'}, {'ForeName': 'Hiren', 'Initials': 'H', 'LastName': 'Mehta', 'Affiliation': 'University of Florida, 3463, Pulmonary and CC , Gainesville, Florida, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jantz', 'Affiliation': 'University of Florida, 3463, Pulmonary, Critical Care, and Sleep Medicine, Gainesville, Florida, United States.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Parikh', 'Affiliation': 'Beth Israel Deaconess Medical Center, 1859, Interventional Pulmonology, Boston, Massachusetts, United States.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Chee', 'Affiliation': 'Beth Israel Deaconess Medical Center, 1859, Division of Thoracic Surgery and Interventional Pulmonology, Boston, Massachusetts, United States.'}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Kaphle', 'Affiliation': 'Tulane University Hospital and Clinic, 21815, Pulmonary Diseases, Critical Care and Environmental Medicine, New Orleans, Louisiana, United States.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sisnega', 'Affiliation': 'Beth Israel Deaconess Medical Center, 1859, Interventional Pulmonary, Boston, Massachusetts, United States.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Fernandez-Bussy', 'Affiliation': 'Mayo Clinic Hospital Jacksonville, 156400, Respiratory and Critical Care Medicine, Jacksonville, Florida, United States.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Majid', 'Affiliation': 'Beth Israel Deaconess Medical Center, 1859, Division of Thoracic Surgery and Interventional Pulmonology, Boston, Massachusetts, United States; amajid@bidmc.harvard.edu.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202001-076OC']
2402,32427114,Use of the Healthy Lifestyle Coaching Chatbot App to Promote Stair-Climbing Habits Among Office Workers: Exploratory Randomized Controlled Trial.,"BACKGROUND


Lack of time for exercise is common among office workers given their busy lives. Because of occupational restrictions and difficulty in taking time off, it is necessary to suggest effective ways for workers to exercise regularly. Sustaining lifestyle habits that increase nonexercise activity in daily life can solve the issue of lack of exercise time. Healthy Lifestyle Coaching Chatbot is a messenger app based on the habit formation model that can be used as a tool to provide a health behavior intervention that emphasizes the importance of sustainability and involvement.
OBJECTIVE


This study aimed to assess the efficacy of the Healthy Lifestyle Coaching Chatbot intervention presented via a messenger app aimed at stair-climbing habit formation for office workers.
METHODS


From February 1, 2018, to April 30, 2018, a total of 106 people participated in the trial after online recruitment. Participants were randomly assigned to the intervention group (n=57) or the control group (n=49). The intervention group received cues and intrinsic and extrinsic rewards for the entire 12 weeks. However, the control group did not receive intrinsic rewards for the first 4 weeks and only received all rewards as in the intervention group from the fifth to twelfth week. The Self-Report Habit Index (SRHI) of participants was evaluated every week, and the level of physical activity was measured at the beginning and end of the trial. SPSS Statistics version 21 (IBM Corp) was used for statistical analysis.
RESULTS


After 4 weeks of intervention without providing the intrinsic rewards in the control group, the change in SRHI scores was 13.54 (SD 14.99) in the intervention group and 6.42 (SD 9.42) in the control group, indicating a significant difference between the groups (P=.04). When all rewards were given to both groups, from the fifth to twelfth week, the change in SRHI scores of the intervention and control groups was comparable at 12.08 (SD 10.87) and 15.88 (SD 13.29), respectively (P=.21). However, the level of physical activity showed a significant difference between the groups after 12 weeks of intervention (P=.045).
CONCLUSIONS


This study provides evidence that intrinsic rewards are important to enhance the sustainability and effectiveness of an intervention. The Healthy Lifestyle Coaching Chatbot program can be a cost-effective method for healthy habit formation.
TRIAL REGISTRATION


Clinical Research Information Service KCT0004009; https://tinyurl.com/w4oo7md.",2020,"However, the level of physical activity showed a significant difference between the groups after 12 weeks of intervention (P=.045).
","['Office Workers', 'office workers given their busy lives', 'From February 1, 2018, to April 30, 2018, a total of 106 people participated in the trial after online recruitment']","['Healthy Lifestyle Coaching Chatbot intervention', 'Healthy Lifestyle Coaching Chatbot App']","['Self-Report Habit Index (SRHI', 'level of physical activity', 'SRHI scores']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",106.0,0.0395995,"However, the level of physical activity showed a significant difference between the groups after 12 weeks of intervention (P=.045).
","[{'ForeName': 'Meihua', 'Initials': 'M', 'LastName': 'Piao', 'Affiliation': 'Office of Hospital Information, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeongju', 'Initials': 'H', 'LastName': 'Ryu', 'Affiliation': 'College of Nursing, Seoul National University, Jongno-gu, Republic of Korea.'}, {'ForeName': 'Hyeongsuk', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College\xa0of\xa0Nursing, Gachon\xa0University, Incheon, Republic of Korea.'}, {'ForeName': 'Jeongeun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Seoul National University, Jongno-gu, Republic of Korea.'}]",JMIR mHealth and uHealth,['10.2196/15085']
2403,32427113,A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness.,"BACKGROUND


The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated.
OBJECTIVE


This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored.
METHODS


This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement.
RESULTS


A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t 116 =2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI -7.423 to 6.301), and hemoglobin A 1c  was 4.5 mmol/mol (95% CI -13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction.
CONCLUSIONS


Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.",2020,"Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37).","['patients with either or both hypertension and type 2 diabetes', 'nonadherent patients with either or both hypertension and type 2 diabetes', '135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years', 'Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting']","['control group that received usual care', 'highly tailored digital intervention', 'Tailored Text and Voice Messaging Intervention', 'highly tailored text message and interactive voice response intervention']","['Medication adherence', 'intentional nonadherence and nonintentional nonadherence', 'Systolic blood pressure and glucose levels', 'quality of life and mechanisms of behavior change', 'behavioral efficacy', 'Intervention fidelity, engagement, and satisfaction', 'Systolic blood pressure', 'Medication Adherence', 'high fidelity, engagement, and satisfaction', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}]",135.0,0.110415,"Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37).","[{'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Kassavou', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Venus', 'Initials': 'V', 'LastName': 'Mirzaei', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brimicombe', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Edwards', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Efthalia', 'Initials': 'E', 'LastName': 'Massou', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'A Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': 'Imperial College London, Cambridge, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Griffin', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}]",Journal of medical Internet research,['10.2196/16629']
2404,32427280,Thyroid function in neonates conceived after hysterosalpingography with iodinated contrast.,"STUDY QUESTION


Does exposure to preconceptional hysterosalpingography (HSG) with iodinated oil-based contrast affect neonatal thyroid function as compared to iodinated water-based contrast?
SUMMARY ANSWER


Preconceptional HSG with iodinated contrast did not influence the neonatal thyroid function.
WHAT IS KNOWN ALREADY


HSG is a commonly applied tubal patency test during fertility work-up in which either oil- or water-based contrast is used. Oil-based contrast contains more iodine compared to water-based contrast. A previous study in an East Asian population found an increased risk of congenital hypothyroidism (CH) in neonates whose mothers were exposed to high amounts of oil-based contrast during HSG.
STUDY DESIGN, SIZE, DURATION


This is a retrospective data analysis of the H2Oil study, a randomized controlled trial (RCT) comparing HSG with the use of oil- versus water-based contrast during fertility work-up. After an HSG with oil-based contrast, 214 women had an ongoing pregnancy within 6 months leading to a live birth compared to 155 women after HSG with water-based contrast.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Of the 369 women who had a live born infant, 208 consented to be approached for future research and 138 provided informed consent to collect data on the thyroid function tests of their offspring (n = 140). Thyroid function tests of these children were retrieved from the Dutch neonatal screening program, which includes the assessment of total thyroxine (T4) in all newborns, followed by thyroid-stimulating hormone only in those with a T4 level of ≤ -0.8 SD score. Furthermore, amount of contrast medium used and time between HSG and conception were compared between the two study groups.
MAIN RESULTS AND THE ROLE OF CHANCE


Data were collected from 140 neonates conceived after HSG with oil-based (n = 76) or water-based (n = 64) contrast. The median T4 concentration was 87.0 nmol/l [76.0-96.0] in the oil group and 90.0 nmol/l [78.0-106.0] in the water group (P = 0.13). None of the neonates had a positive screening result for CH.The median amount of contrast medium used was 9.0 ml [interquartile range (IQR), 6.0-11.8] in the oil-group and 10.0 ml [IQR, 7.5-14.0] in the water group (P = 0.43). No influence of the amount of contrast on the effect of contrast group on T4 concentrations was found (P-value for interaction, 0.37).
LIMITATIONS, REASONS FOR CAUTION


A relatively small sample size and possible attrition at follow-up are limitations of this study. Although our results suggest that the use of iodinated contrast media for HSG is safe for the offspring, the impact of a decrease in maternal thyroid function on offspring neurodevelopment could not be excluded, as data on maternal thyroid function after HSG and during conception were lacking.
WIDER IMPLICATIONS OF THE FINDINGS


As HSG with oil-based contrast does not affect thyroid function of the offspring, there is no reason to withhold this contrast to infertile women undergoing HSG. Future studies should investigate whether HSG with iodinated contrast influences the periconceptional maternal thyroid function and, consequently, offspring neurodevelopment.
STUDY FUNDING/COMPETING INTEREST(S)


This study received no funding. The original H2Oil RCT was an investigator-initiated study that was funded by the two academic institutions (Academic Medical Center and VU University Medical Center) of the Amsterdam UMC. The funders had no role in study design, collection, analysis and intrepretation of the data. I.R. reports receiving travel fee from Guerbet. C.B.L. reports speakers fee from Ferring in the past and research grants from Ferring, Merck and Guerbet. K.D. reports receiving travel fee and speakers fee from Guerbet. B.W.M. is supported by a NHMRC Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck KGaA and Guerbet and travel and research grants from Merck KGaA and Guerbet. V.M. reports receiving travel fee and speakers fee as well as research grants from Guerbet. The other authors do not report conflicts of interest.
TRIAL REGISTRATION NUMBER


Netherlands Trial Register NTR 7526 (Neonates born after the H2Oil study), NTR 3270 (original H2Oil study), www.trialregister.nl.",2020,"No influence of the amount of contrast on the effect of contrast group on T4 concentrations was found (P-value for interaction, 0.37).
","['in all newborns, followed by thyroid-stimulating hormone only in those with a T4 level of ≤\u2009-0.8 SD score', 'infertile women undergoing HSG', 'NTR 7526 (Neonates born after the H2Oil study), NTR 3270 (original H2Oil study), www.trialregister.nl', 'East Asian population', 'Of the 369 women who had a live born infant', '208 consented to be approached for future research and 138 provided informed consent to collect data on the thyroid function tests of their offspring (n\u2009=\u2009140']","['Oil-based contrast contains more iodine', 'HSG']","['neonatal thyroid function', 'maternal thyroid function', 'Thyroid function', 'risk of congenital hypothyroidism (CH', 'median T4 concentration', 'total thyroxine (T4', 'T4 concentrations']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0040130', 'cui_str': 'Thyroid panel'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0010308', 'cui_str': 'Congenital hypothyroidism'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}]",214.0,0.03966,"No influence of the amount of contrast on the effect of contrast group on T4 concentrations was found (P-value for interaction, 0.37).
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Roest', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Portela', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Rijswijk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Koks', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, De Run 4600, 5504 DB, Veldhoven, the Netherlands.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Scenic Blvd, Clayton, VIC 3800, Australia.'}, {'ForeName': 'M J J', 'Initials': 'MJJ', 'LastName': 'Finken', 'Affiliation': ""Department of Paediatric Endocrinology, Amsterdam UMC, Vrije Universiteit Amsterdam, Emma Children's Hospital, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa049']
2405,32421401,Carbetocin versus oxytocin for prevention of postpartum hemorrhage in hypertensive women undergoing elective cesarean section.,"Objective : Assess the efficacy and safety of carbetocin, versus oxytocin in the prevention of postpartum hemorrhage in hypertensive women. Study design : A randomized clinical trial. Setting : Obstetrics and Gynecology Department of Suez Canal University Hospital. Patients : One hundred and sixty hypertensive pregnant women who underwent CS. Interventions : Patients were randomized to receive either 10 IU oxytocin or 100 μg carbetocin. Primary outcomes included estimated blood loss, blood transfusion, hemoglobin (HB), and hematocrit changes pre- and post-delivery and the use of additional uterotonics. Results : The postoperative HB was not different from preoperative HB in the carbetocin group (11.8 ± 1.2 vs. 11.2 ± 1.2 g/dL) while it decreased significantly in the oxytocin group (12.1 ± 3.8 vs. 10.4 ± 1.1 g/dL, p < 0.001). Blood loss was significantly more among the oxytocin group (679.5 ± 200.25 vs. 424.75 ± 182.59 ml) in the carbetocin group (p < 0.001). Nausea, vomiting, and sweating were reported more significantly in oxytocin group patients. Conclusion : Carbetocin was more effective than oxytocin in reducing intraoperative and postoperative blood loss.",2020,Blood loss was significantly more among the oxytocin group (679.5 ± 200.25 vs. 424.75 ± 182.59 ml) in the carbetocin group (p < 0.001).,"['One hundred and sixty hypertensive pregnant women who underwent CS', 'hypertensive women', 'Setting : Obstetrics and Gynecology Department of Suez Canal University Hospital', 'hypertensive women undergoing elective cesarean section', 'Patients ']","['10 IU oxytocin', 'carbetocin, versus oxytocin', 'Carbetocin versus oxytocin', 'oxytocin']","['Blood loss', 'postoperative HB', 'Nausea, vomiting, and sweating', 'intraoperative and postoperative blood loss', 'estimated blood loss, blood transfusion, hemoglobin (HB), and hematocrit changes pre- and post-delivery and the use of additional uterotonics']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0587480', 'cui_str': 'Obstetrics and gynecology department'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0054670', 'cui_str': 'carbetocin'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3653843', 'cui_str': 'UTEROTONICS'}]",160.0,0.217339,Blood loss was significantly more among the oxytocin group (679.5 ± 200.25 vs. 424.75 ± 182.59 ml) in the carbetocin group (p < 0.001).,"[{'ForeName': 'Zakia M', 'Initials': 'ZM', 'LastName': 'Ibrahim', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Waleed A', 'Initials': 'WA', 'LastName': 'Sayed Ahmed', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Eman M', 'Initials': 'EM', 'LastName': 'Abd El-Hamid', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Omima T', 'Initials': 'OT', 'LastName': 'Taha', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Amira M', 'Initials': 'AM', 'LastName': 'Elbahie', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}]",Hypertension in pregnancy,['10.1080/10641955.2020.1768268']
2406,32421444,"Neoadjuvant Chemotherapy in High-Risk Soft Tissue Sarcomas: Final Results of a Randomized Trial From Italian (ISG), Spanish (GEIS), French (FSG), and Polish (PSG) Sarcoma Groups.","PURPOSE


To determine whether the administration of histology-tailored neoadjuvant chemotherapy (HT) was superior to the administration of standard anthracycline plus ifosfamide neoadjuvant chemotherapy (A+I) in high-risk soft tissue sarcoma (STS) of an extremity or the trunk wall.
PATIENTS AND METHODS


This was a randomized, open-label, phase III trial. Patients had localized high-risk STS (grade 3; size, ≥ 5 cm) of an extremity or trunk wall, belonging to one of the following five histologic subtypes: high-grade myxoid liposarcoma (HG-MLPS); leiomyosarcoma (LMS), synovial sarcoma (SS), malignant peripheral nerve sheath tumor (MPNST), and undifferentiated pleomorphic sarcoma (UPS). Patients were randomly assigned in a 1:1 ratio to receive three cycles of A+I or HT. The HT regimens were as follows: trabectedin in HG-MLPS; gemcitabine plus dacarbazine in LMS; high-dose prolonged-infusion ifosfamide in SS; etoposide plus ifosfamide in MPNST; and gemcitabine plus docetaxel in UPS. Primary and secondary end points were disease-free survival (DFS) and overall survival (OS), estimated using the Kaplan-Meier method and compared using Cox models adjusted for treatment and stratification factors. The study is registered at ClinicalTrials.gov (identifier NCT01710176).
RESULTS


Between May 2011 and May 2016, 287 patients (UPS: n = 97 [33.8%]; HG-MLPS: n = 65 [22.6%]; SS: n = 70 [24.4%]; MPNST: n = 27 [9.4%]; and LMS: n = 28 [9.8%]) were randomly assigned to either A+I or HT. At the final analysis, with a median follow-up of 52 months, the projected DFS and OS probabilities were 0.55 and 0.47 (log-rank  P  = .323) and 0.76 and 0.66 (log-rank  P  = .018) at 60 months in the A+I arm and HT arm, respectively. No treatment-related deaths were observed.
CONCLUSION


In a population of patients with localized high-risk STS, HT was not associated with a better DFS or OS, suggesting that A+I should remain the regimen to choose whenever neoadjuvant chemotherapy is used in patients with high-risk STS.",2020,"In a population of patients with localized high-risk STS, HT was not associated with a better DFS or OS, suggesting that A+I should remain the regimen to choose whenever neoadjuvant chemotherapy is used in patients with high-risk STS.","['high-risk soft tissue sarcoma (STS) of an extremity or the trunk wall', 'patients with high-risk STS', 'Italian (ISG), Spanish (GEIS), French (FSG), and Polish (PSG', 'High-Risk Soft Tissue Sarcomas', 'Patients had localized high-risk STS (grade 3; size, ≥ 5 cm) of an extremity or trunk wall, belonging to one of the following five histologic subtypes: high-grade myxoid liposarcoma (HG-MLPS); leiomyosarcoma (LMS), synovial sarcoma (SS), malignant peripheral nerve sheath tumor (MPNST), and undifferentiated pleomorphic sarcoma (UPS', '287 patients (UPS: n = 97 [33.8%]; HG-MLPS: n = 65 [22.6%]; SS: n = 70 [24.4%]; MPNST: n = 27 [9.4%]; and LMS: n = 28 [9.8']","['ifosfamide in SS; etoposide plus ifosfamide', 'histology-tailored neoadjuvant chemotherapy (HT', 'Neoadjuvant Chemotherapy', 'A+I or HT', 'gemcitabine plus docetaxel', 'standard anthracycline plus ifosfamide neoadjuvant chemotherapy (A+I', 'gemcitabine plus dacarbazine']","['projected DFS and OS probabilities', 'disease-free survival (DFS) and overall survival (OS), estimated using the Kaplan-Meier method and compared using Cox models adjusted for treatment and stratification factors']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0459558', 'cui_str': 'Body wall structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1301142', 'cui_str': 'WHO tumor classification'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0206634', 'cui_str': 'Myxoid liposarcoma'}, {'cui': 'C0023269', 'cui_str': 'Leiomyosarcoma'}, {'cui': 'C0039101', 'cui_str': 'Synovial sarcoma'}, {'cui': 'C0751690', 'cui_str': 'Malignant peripheral nerve sheath tumor'}, {'cui': 'C0334463', 'cui_str': 'Fibrous histiocytoma, malignant'}, {'cui': 'C4517682', 'cui_str': '287'}]","[{'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0039101', 'cui_str': 'Synovial sarcoma'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}]","[{'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0010234', 'cui_str': 'Cox Models'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.10756,"In a population of patients with localized high-risk STS, HT was not associated with a better DFS or OS, suggesting that A+I should remain the regimen to choose whenever neoadjuvant chemotherapy is used in patients with high-risk STS.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gronchi', 'Affiliation': 'Department of Surgery, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Palmerini', 'Affiliation': 'Chemotherapy Unit, IRCCS, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Quagliuolo', 'Affiliation': 'Department of Surgery, Istituto Clinico Humanitas, Rozzano, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martin Broto', 'Affiliation': 'Medical Oncology Department, University Hospital Virgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lopez Pousa', 'Affiliation': 'Department of Cancer Medicine, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Grignani', 'Affiliation': ""Department of Cancer Medicine, Fondazione del Piemonte per l'Oncologia, IRCCS, Candiolo, Turin, Italy.""}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Brunello', 'Affiliation': 'Department of Oncology, Medical Oncology 1 Unit, Istituto Oncologico Veneto, IRCCS, Padova, Italy.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Cancer Medicine, Centre Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Tendero', 'Affiliation': 'Department of Surgery, Hospital Universitari Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Diaz Beveridge', 'Affiliation': 'Department of Cancer Medicine, Hospital Universitari i Politècnic La Fe, Valencia, Spain.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Ferraresi', 'Affiliation': 'Department of Cancer Medicine, Istituto Regina Elena, Rome, Italy.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Lugowska', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Centrum Onkologii, Instytutim, Marii Sklodowskiej-Curie, Warszawa, Poland.'}, {'ForeName': 'Domenico Franco', 'Initials': 'DF', 'LastName': 'Merlo', 'Affiliation': 'Research and Statistics Infrastructure, Azienda Unità Sanitaria Locale, IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Fontana', 'Affiliation': 'Clinical Trial Center and Department of Epidemiology, IRCCS Azienda Ospedaliera Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Marchesi', 'Affiliation': 'Clinical Trial Center, Italian Sarcoma Group, Bologna, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Braglia', 'Affiliation': 'Research and Statistics Infrastructure, Azienda Unità Sanitaria Locale, IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Davide Maria', 'Initials': 'DM', 'LastName': 'Donati', 'Affiliation': 'Department of Orthopedic Oncology, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Palassini', 'Affiliation': 'Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Bianchi', 'Affiliation': 'Department of Orthopedic Oncology, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Marrari', 'Affiliation': 'Department of Cancer Medicine, Istituto Clinico Humanitas, Rozzano, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Morosi', 'Affiliation': 'Department of Radiology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Stacchiotti', 'Affiliation': 'Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bagué', 'Affiliation': 'Department of Pathology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Jean Michel', 'Initials': 'JM', 'LastName': 'Coindre', 'Affiliation': 'Department of Pathology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Angelo Paolo', 'Initials': 'AP', 'LastName': 'Dei Tos', 'Affiliation': 'Department of Pathology, Treviso General Hospital Treviso, Padova, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Picci', 'Affiliation': 'Laboratory of Oncologic Research, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bruzzi', 'Affiliation': 'Clinical Trial Center and Department of Epidemiology, IRCCS Azienda Ospedaliera Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.'}, {'ForeName': 'Paolo Giovanni', 'Initials': 'PG', 'LastName': 'Casali', 'Affiliation': 'Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03289']
2407,23557321,Using formative research to design a context-specific behaviour change strategy to improve infant and young child feeding practices and nutrition in Nepal.,"Global recommendations on strategies to improve infant feeding, care and nutrition are clear; however, there is limited literature that explains methods for tailoring these recommendations to the local context where programmes are implemented. This paper aims to: (1) highlight the individual, cultural and environmental factors revealed by formative research to affect infant and young child feeding and care practices in Baitadi district of Far Western Nepal; and (2) outline how both quantitative and qualitative research methods were used to design a context-specific behaviour change strategy to improve child nutrition. Quantitative data on 750 children aged 12-23 months and their families were collected via surveys administered to mothers. The participants were selected using a multistage cluster sampling technique. The survey asked about knowledge, attitude and behaviours relating to infant and young child feeding. Qualitative data on breastfeeding and complementary feeding beliefs and practices were also collected from a separate sample via focus group discussions with mothers, and key informant interviews with mothers-in-law and husbands. Key findings revealed gaps in knowledge among many informants resulting in suboptimal infant and young child feeding practices - particularly with relation to duration of exclusive breastfeeding and dietary diversity of complementary foods. The findings from this research were then incorporated into a context-specific nutrition behaviour change communication strategy.",2015,Key findings revealed gaps in knowledge among many informants resulting in suboptimal infant and young child feeding practices - particularly with relation to duration of exclusive breastfeeding and dietary diversity of complementary foods.,"['750 children aged 12-23 months and their families were collected via surveys administered to mothers', 'infant and young child feeding practices and nutrition in Nepal']",[],[],"[{'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}]",[],[],750.0,0.0262138,Key findings revealed gaps in knowledge among many informants resulting in suboptimal infant and young child feeding practices - particularly with relation to duration of exclusive breastfeeding and dietary diversity of complementary foods.,"[{'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Locks', 'Affiliation': 'Helen Keller International Headquarters, New York, New York, USA.'}, {'ForeName': 'Pooja R', 'Initials': 'PR', 'LastName': 'Pandey', 'Affiliation': 'Helen Keller International, Kathmandu, Nepal.'}, {'ForeName': 'Akoto K', 'Initials': 'AK', 'LastName': 'Osei', 'Affiliation': 'Helen Keller International, Asia Pacific Regional Office, Phnom Penh, Cambodia.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Spiro', 'Affiliation': 'Helen Keller International, Kathmandu, Nepal.'}, {'ForeName': 'Debendra P', 'Initials': 'DP', 'LastName': 'Adhikari', 'Affiliation': 'Helen Keller International, Kathmandu, Nepal.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Haselow', 'Affiliation': 'Helen Keller International, Asia Pacific Regional Office, Phnom Penh, Cambodia.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Quinn', 'Affiliation': 'Helen Keller International Headquarters, New York, New York, USA.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Nielsen', 'Affiliation': 'Helen Keller International Headquarters, New York, New York, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12032']
2408,32427325,"Congruence Gaps Between Adolescents With Cancer and Their Families Regarding Values, Goals, and Beliefs About End-of-Life Care.","Importance


Lack of pediatric advance care planning has been associated with poor communication, increased hospitalization, poor quality of life, and legal actions. Clinicians presume that families understand adolescents' treatment preferences for end-of-life care.
Objective


To examine patient-reported end-of-life values and needs of adolescents with cancer and congruence with their families' understanding of these needs.
Design, Setting, and Participants


This cross-sectional survey was conducted among adolescent-family dyads from July 16, 2016, to April 30, 2019, at 4 tertiary care pediatric US hospitals. Participants included 80 adolescent-family dyads (160 participants) within a larger study facilitating pediatric advance care planning. Adolescent eligibility criteria included being aged 14 to 21 years, English speaking, being diagnosed with cancer at any stage, and knowing their diagnosis. Family included legal guardians for minors or chosen surrogate decision-makers for those aged 18 years or older. Data analysis was performed from April 2019 to November 2019.
Exposure


Session 1 of the 3-session Family Centered Pediatric Advance Care Planning for Teens With Cancer intervention.
Main Outcomes and Measures


The main outcome was congruence between adolescents with cancer and their families regarding adolescents' values, goals, and beliefs about end-of-life care. Prevalence-adjusted and bias-adjusted κ (PABAK) values were used to measure congruence on the Lyon Advance Care Planning Survey-Revised (Patient and Surrogate versions).
Results


A total of 80 adolescent-family dyads (160 participants) were randomized to the intervention group in the original trial. Among the adolescents, 44 (55.0%) were female and 60 (75.0%) were white, with a mean (SD) age of 16.9 (1.8) years. Among family members, 66 (82.5%) were female and 65 (81.3%) were white, with a mean (SD) age of 45.3 (8.3) years. Family members' understanding of their adolescent's beliefs about the best time bring up end-of-life decisions was poor: 86% of adolescents wanted early timing (before getting sick, while healthy, when first diagnosed, when first sick from a life-threatening illness, or all of the above), but only 39% of families knew this (PABAK, 0.18). Families' understanding of what was important to their adolescents when dealing with their own dying was excellent for wanting honest answers from their physician (PABAK, 0.95) and understanding treatment choices (PABAK, 0.95) but poor for dying a natural death (PABAK, 0.18) and being off machines that extend life, if dying (PABAK, 0).
Conclusions and Relevance


Many families had a poor understanding of their adolescent's values regarding their own end-of-life care, such as when to initiate end-of-life conversations and preference for being off machines that extend life. Pediatric advance care planning could minimize these misunderstandings with the potential for a substantial impact on quality of care.",2020,"Families' understanding of what was important to their adolescents when dealing with their own dying was excellent for wanting honest answers from their physician (PABAK, 0.95) and understanding treatment choices (PABAK, 0.95) but","['Family included legal guardians for minors or chosen surrogate decision-makers for those aged 18 years or older', 'Teens With Cancer intervention', 'Among the adolescents, 44 (55.0%) were female and 60 (75.0%) were white, with a mean (SD) age of 16.9 (1.8) years', 'Participants\n\n\nThis cross-sectional survey was conducted among adolescent-family dyads from July 16, 2016, to April 30, 2019, at 4 tertiary care pediatric US hospitals', 'adolescents with cancer and congruence with their families', 'Participants included 80 adolescent-family dyads (160 participants) within a larger study facilitating pediatric advance care planning', 'Among family members, 66 (82.5%) were female and 65 (81.3%) were white, with a mean (SD) age of 45.3 (8.3) years', 'Adolescent eligibility criteria included being aged 14 to 21 years, English speaking, being diagnosed with cancer at any stage, and knowing their diagnosis', '80 adolescent-family dyads (160 participants']",['3-session Family Centered Pediatric Advance Care Planning'],"['hospitalization, poor quality of life, and legal actions', 'Prevalence-adjusted and bias-adjusted κ (PABAK) values', ""adolescents with cancer and their families regarding adolescents' values, goals, and beliefs about end-of-life care""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0554244', 'cui_str': 'Maker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205309', 'cui_str': 'Known'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0039548', 'cui_str': 'Terminal care'}]",80.0,0.0323796,"Families' understanding of what was important to their adolescents when dealing with their own dying was excellent for wanting honest answers from their physician (PABAK, 0.95) and understanding treatment choices (PABAK, 0.95) but","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friebert', 'Affiliation': ""Haslinger Family Pediatric Palliative Care Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Grossoehme', 'Affiliation': ""Haslinger Family Pediatric Palliative Care Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Justin N', 'Initials': 'JN', 'LastName': 'Baker', 'Affiliation': 'Division of Quality of Life and Palliative Care, St Jude Research Hospital, Memphis, Tennessee.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Needle', 'Affiliation': 'Center for Bioethics, Department of Pediatrics, University of Minnesota, Minneapolis.'}, {'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Thompkins', 'Affiliation': ""Center for Translational Research, Children's Research Institute, Children's National Hospital, Washington, DC.""}, {'ForeName': 'Yao I', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Research, Children's Research Institute, Children's National Hospital, Washington, DC.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Research, Children's Research Institute, Children's National Hospital, Washington, DC.""}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.5424']
2409,32421440,Implementation of Minimally Invasive Esophagectomy From a Randomized Controlled Trial Setting to National Practice.,"PURPOSE


The aim of this study was to examine the external validity of the randomized TIME trial, when minimally invasive esophagectomy (MIE) was implemented nationally in the Netherlands, using data from the Dutch Upper GI Cancer Audit (DUCA) for transthoracic esophagectomy.
METHODS


Original patient data from the TIME trial were extracted along with data from the DUCA dataset (2011-2017). Multivariate analysis, with adjustment for patient factors, tumor factors, and year of surgery, was performed for the effect of MIE versus open esophagectomy on clinical outcomes.
RESULTS


One hundred fifteen patients from the TIME trial (59 MIE  v  56 open) and 4,605 patients from the DUCA dataset (2,652 MIE  v  1,953 open) were included. In the TIME trial, univariate analysis showed that MIE reduced pulmonary complications and length of hospital stay. On the contrary, in the DUCA dataset, MIE was associated with increased total and pulmonary complications and reoperations; however, benefits included increased proportion of R0 margin and lymph nodes harvested, and reduced 30-day mortality. Multivariate analysis from the TIME trial showed that MIE reduced pulmonary complications (odds ratio [OR], 0.19; 95% CI, 0.06 to 0.61). In the DUCA dataset, MIE was associated with increased total complications (OR, 1.36; 95% CI, 1.19 to 1.57), pulmonary complications (OR, 1.50; 95% CI, 1.29 to 1.74), reoperations (OR, 1.74; 95% CI, 1.42 to 2.14), and length of hospital stay. Multivariate analysis of the combined and MIE datasets showed that inclusion in the TIME trial was associated with a reduction in reoperations, Clavien-Dindo grade > 1 complications, and length of hospital stay.
CONCLUSION


When adopted nationally outside the TIME trial, MIE was associated with an increase in total and pulmonary complications and reoperation rate. This may reflect nonexpert surgeons outside of high-volume centers performing this minimally invasive technique in a nonstandardized fashion outside of a controlled environment.",2020,"Multivariate analysis from the TIME trial showed that MIE reduced pulmonary complications (odds ratio [OR], 0.19; 95% CI, 0.06 to 0.61).","['Original patient data from the TIME trial were extracted along with data from the DUCA dataset (2011-2017', 'One hundred fifteen patients from the TIME trial (59 MIE  v  56 open) and 4,605 patients from the DUCA dataset ']","['MIE versus open esophagectomy', 'Minimally Invasive Esophagectomy', 'minimally invasive esophagectomy (MIE']","['total complications', 'total and pulmonary complications and reoperation rate', 'pulmonary complications', 'pulmonary complications and length of hospital stay', 'length of hospital stay', 'reoperations, Clavien-Dindo grade > 1 complications, and length of hospital stay', '30-day mortality', 'total and pulmonary complications and reoperations', 'MIE reduced pulmonary complications']","[{'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0203057', 'cui_str': 'Upper gastrointestinal tract series'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",115.0,0.249686,"Multivariate analysis from the TIME trial showed that MIE reduced pulmonary complications (odds ratio [OR], 0.19; 95% CI, 0.06 to 0.61).","[{'ForeName': 'Sheraz R', 'Initials': 'SR', 'LastName': 'Markar', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Ni', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Gisbertz', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'van der Werf', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Straatman', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'van der Peet', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Cuesta', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Hanna', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02483']
2410,32427115,Mobile App to Improve House Officers' Adherence to Advanced Cardiac Life Support Guidelines: Quality Improvement Study.,"BACKGROUND


Effective and timely delivery of cardiac arrest interventions during in-hospital cardiac arrest resuscitation is associated with greater survival. Whether a mobile app that provides timely reminders of critical interventions improves adherence to Advanced Cardiovascular Life Support (ACLS) guidelines among house officers, who may lack experience in leading resuscitations, remains unknown.
OBJECTIVE


The aim of this study was to assess the impact of a commercially available, dynamic mobile app on house officers' adherence to ACLS guidelines.
METHODS


As part of a quality improvement initiative, internal medicine house officers were invited to participate and randomized to lead 2 consecutive cardiac arrest simulations, one with a novel mobile app and one without a novel mobile app. All simulations included 4 cycles of cardiopulmonary resuscitation with different cardiac arrest rhythms and were video recorded. The coprimary end points were chest compression fraction and number of correct interventions in each simulation. The secondary end point was incorrect interventions, defined as interventions not indicated by the 2015 ACLS guidelines. Paired t tests compared performance with and without the mobile app.
RESULTS


Among 53 house officers, 26 house officers were randomized to lead the first simulation with the mobile app, and 27 house officers were randomized to do so without the app. Use of the mobile app was associated with a higher number of correct ACLS interventions (out of 7; mean 6.2 vs 5.1; absolute difference 1.1 [95% CI 0.6 to 1.6]; P<.001) as well as fewer incorrect ACLS interventions (mean 0.3 vs 1.0; absolute difference -0.7 [95% CI -0.3 to -1.0]; P<.001). Simulations with the mobile app also had a marginally higher chest compression fraction (mean 90.9% vs 89.0%; absolute difference 1.9% [95% CI 0.6% to 3.4%]; P=.007).
CONCLUSIONS


This proof-of-concept study suggests that this novel mobile app may improve adherence to ACLS protocols, but its effectiveness on survival in real-world resuscitations remains unknown.",2020,"RESULTS


Among 53 house officers","['53 house officers', '26 house officers were randomized to lead the first simulation with the mobile app, and 27 house officers']",['novel mobile app and one without a novel mobile app'],"['higher number of correct ACLS interventions', 'chest compression fraction', 'incorrect ACLS interventions', 'chest compression fraction and number of correct interventions']","[{'cui': 'C0401975', 'cui_str': 'House officer'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",,0.123049,"RESULTS


Among 53 house officers","[{'ForeName': 'Vittal', 'Initials': 'V', 'LastName': 'Hejjaji', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Ali O', 'Initials': 'AO', 'LastName': 'Malik', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Poghni A', 'Initials': 'PA', 'LastName': 'Peri-Okonny', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Merrill', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wooldridge', 'Affiliation': 'Department of Internal Medicine, University of Missouri Kansas City, Kansas City, MO, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Chan', 'Affiliation': ""Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, University of Missouri Kansas City, Kansas City, MO, United States.""}]",JMIR mHealth and uHealth,['10.2196/15762']
2411,32427125,Immediate effect of Kapalbhathi pranayama on short term heart rate variability (HRV) in healthy volunteers.,"Objectives Kapalbhathi Pranayam (Kapal = forehead; bhati = shining) is a breathing exercise that has been practiced to cleanse the frontal brain in traditional practices like yoga. Still, there exists a dearth of literature on the effect of Kapalbhathi pranayama on physiological systems. So this present study was carried out to find the immediate effect of ""kapalbhathi Pranayam"" practice for the period of 5 min on cardiac autonomic function among the healthy volunteers. Materials and methods Apparently 50 healthy volunteers includes both sex were participated. They were randomly divided into Pranayama (n-25) and control (n-25) group. Pranayama group was practiced kapalbhathi pranayama 5 min (5 cycles) and control group was allowed to do normal breathing (12-16 breath/min). Lead II ECG was recorded for 5 min using simple AD converter before, immediately after practice and 20 min of recovery period. Results One way Analysis of variance (ANOVA) followed by post hoc test was done using R statistical software. There was a significant (p < 0.05) parasympathetic withdrawal (Root Mean Square of the Successive Differences (RMSSD) - p < 0.04 and HF n.u - p < 0.05) was found in the pranayama group immediately after practice and its was changed to parasympathetic domination (RMSSD - p < 0.04 and HF n.u - p < 0.05) after 20 min of recovery period. Conclusion The present study suggested that though there was parasympathetic withdrawal immediately after practicing kapalbhathi pranayama, 20 min after the recovery period showed a parasympathetic domination in the pranayama group subjects. However, further studies are required to warrant the findings of this study.",2020,There was a significant (p < 0.05) parasympathetic withdrawal (Root Mean Square of the Successive Differences (RMSSD) - p < 0.04 and HF,"['50 healthy volunteers includes both sex were participated', 'healthy volunteers']","['Objectives Kapalbhathi Pranayam (Kapal\xa0', 'Kapalbhathi pranayama', 'kapalbhathi pranayama 5\xa0min (5\xa0cycles) and control group was allowed to do normal breathing', 'HF']","['short term heart rate variability (HRV', 'parasympathetic domination', 'parasympathetic withdrawal']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231795', 'cui_str': 'Normal respiratory function'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",50.0,0.0201556,There was a significant (p < 0.05) parasympathetic withdrawal (Root Mean Square of the Successive Differences (RMSSD) - p < 0.04 and HF,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lalitha', 'Affiliation': 'Department of Physiology, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra Institute of Higher Education and Research (SRIHER), Chennai, Tamil Nadu, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Maheshkumar', 'Affiliation': 'Department of Physiology & Biochemistry, Government Yoga and Naturopathy Medical College and Hospital, 600106, Chennai, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Shobana', 'Affiliation': 'Department of Physiology, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra Institute of Higher Education and Research (SRIHER), Chennai, Tamil Nadu, India.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Deepika', 'Affiliation': 'Department of Physiology, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra Institute of Higher Education and Research (SRIHER), Chennai, Tamil Nadu, India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0331']
2412,32427415,"Authors' reply re: Antenatal magnesium sulphate for the prevention of cerebral palsy in infants born preterm: a double-blind, randomised, placebo-controlled, multi-centre trial: Time range for treatment with magnesium sulphate.",,2020,,"['born preterm', 'cerebral palsy in infants']","['magnesium sulphate', 'Antenatal magnesium sulphate', 'placebo']",[],"[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.770591,,"[{'ForeName': 'Hanne Trap', 'Initials': 'HT', 'LastName': 'Wolf', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Brok', 'Affiliation': 'Department of Paediatric and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Tine Brink', 'Initials': 'TB', 'LastName': 'Henriksen', 'Affiliation': 'Perinatal Epidemiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Hanne Kristine', 'Initials': 'HK', 'LastName': 'Hegaard', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Gorm', 'Initials': 'G', 'LastName': 'Greisen', 'Affiliation': 'Department of Neonatology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Weber', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Pryds', 'Affiliation': 'Department of Paediatrics, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Jannie Dalby', 'Initials': 'JD', 'LastName': 'Salvig', 'Affiliation': 'Department of Obstetrics and Gynaecology, Skejby University Hospital, Skejby, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Hedegaard', 'Affiliation': 'Department of Obstetrics, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Lene Drasbek', 'Initials': 'LD', 'LastName': 'Huusom', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Hvidovre, Denmark.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16267']
2413,32422870,Urinary Metabolomic Profiling Analysis and Evaluation of the Effect of  Ecklonia cava  Extract Intake.,"Metabolomics is a powerful tool for the investigation of interactions between diet, nutrients, and human metabolism.  Ecklonia cava  is an edible brown alga that is abundantly found in Korea and Japan and contains unique polyphenols referred to as phlorotannins. However, there are few metabolomics studies related to the effects of polyphenols in humans. In this study, we performed a mass spectrometry-based metabolomics analysis of urine samples from participants with a body mass index (BMI) higher than 25 kg/m 2  and lower than 30 kg/m 2  to investigate the effects of the intake of seapolynol isolated from  E. cava . Metabolomic profiling showed that the levels of riboflavin, urocanic acid, 5-hydroxy-6-methoxyindole glucuronide, and guanidino valeric acid were significantly increased in the seapolynol intake group compared with the placebo group. A correlation analysis was performed to identify the association between the metabolites' levels and clinical characteristics related to body fat. Among the metabolites whose concentrations changed in the seapolynol intake group, riboflavin was associated with BMI, body weight, fat mass, and percent body fat. These findings suggest that the decreased body fat induced by the intake of seapolynol is related to an increase in the antioxidant effect of riboflavin.",2020,"Metabolomic profiling showed that the levels of riboflavin, urocanic acid, 5-hydroxy-6-methoxyindole glucuronide, and guanidino valeric acid were significantly increased in the seapolynol intake group compared with the placebo group.",['participants with a body mass index (BMI) higher than 25 kg/m 2  and lower than 30 kg/m 2  to investigate the effects of the intake of seapolynol isolated from  E. cava '],"['Ecklonia cava  Extract Intake', 'riboflavin', 'placebo']","['levels of riboflavin, urocanic acid, 5-hydroxy-6-methoxyindole glucuronide, and guanidino valeric acid']","[{'cui': 'C0231254', 'cui_str': 'Increased body mass index'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0521083', 'cui_str': 'Piper methysticum'}]","[{'cui': 'C3539019', 'cui_str': 'Ecklonia cava extract'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0042054', 'cui_str': 'Urocanic acid'}, {'cui': 'C0613386', 'cui_str': '5-hydroxy-6-methoxyindole glucuronide'}, {'cui': 'C0068263', 'cui_str': 'valeric acid'}]",,0.0419617,"Metabolomic profiling showed that the levels of riboflavin, urocanic acid, 5-hydroxy-6-methoxyindole glucuronide, and guanidino valeric acid were significantly increased in the seapolynol intake group compared with the placebo group.","[{'ForeName': 'Juyeon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Integrated Metabolomics Research Group, Western Seoul Center, Korea Basic Science Institute, Seoul 120-140, Korea.'}, {'ForeName': 'Youngae', 'Initials': 'Y', 'LastName': 'Jung', 'Affiliation': 'Integrated Metabolomics Research Group, Western Seoul Center, Korea Basic Science Institute, Seoul 120-140, Korea.'}, {'ForeName': 'Eunok', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Seoyeong', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Integrated Metabolomics Research Group, Western Seoul Center, Korea Basic Science Institute, Seoul 120-140, Korea.'}, {'ForeName': 'Do Hyun', 'Initials': 'DH', 'LastName': 'Ryu', 'Affiliation': 'Department of Chemistry, Sungkyunkwan University, Suwon 440-746, Korea.'}, {'ForeName': 'Oran', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Geum-Sook', 'Initials': 'GS', 'LastName': 'Hwang', 'Affiliation': 'Integrated Metabolomics Research Group, Western Seoul Center, Korea Basic Science Institute, Seoul 120-140, Korea.'}]",Nutrients,['10.3390/nu12051407']
2414,32421480,Pain control and early wound healing effect using sitz bath with ozonised water after haemorrhoidectomy.,"OBJECTIVE


Studies have shown that ozone in an aqueous state on a scar, because of its antibacterial effect, aids wound-healing. This study aimed to compare the pain control effect, based on the time to wound healing, of using a sitz bath with ozonised water with that of using a sitz bath with ordinary tap water in patients who have had a haemorrhoidectomy.
METHOD


Patients were divided into two equal-sized groups: Group O used a sitz bath with ozonised water after haemorrhoidectomy and patients in Group T used a sitz bath with ordinary tap water. Different concentrations (1ppm, 2ppm and 4ppm) of ozonized water were tested to determine their bactericidal activities. Pain levels were measured using the Visual Analogue Scale (ranging from 0-10 where 0 is 'no pain' and 10 is 'unbearable pain'), on days two, three and seven. Cohort analysis was retrospectively performed on the prospectively randomised collected data for this study.
RESULTS


A total of 80 patients participated in the study. No case showed any signs of bacterial growth. On postoperative day seven, patients in Group O showed a significantly lower pain level than those in Group T (1.35±0.48 versus 2.40±0.9; p<0.001). The time needed for anus scars to be completely healed was significantly shorter for Group O than that for Group T (2.75±0.63 weeks versus 3.85±0.80 weeks; p<0.001).
CONCLUSION


The results of this study showed that using a sitz bath with ozonised water reduced pain and accelerated healing in patients who have had a haemorrhoidectomy.",2020,"On postoperative day seven, patients in Group O showed a significantly lower pain level than those in Group T (1.35±0.48 versus 2.40±0.9; p<0.001).","['80 patients participated in the study', 'patients who have had a haemorrhoidectomy', 'Patients']","['sitz bath with ozonised water after haemorrhoidectomy', 'sitz bath with ozonised water after haemorrhoidectomy and patients in Group T used a sitz bath with ordinary tap water']","['pain level', 'signs of bacterial growth', 'Visual Analogue Scale', 'pain control effect', 'Pain levels', 'Pain control and early wound healing effect', 'pain and accelerated healing', 'time needed for anus scars to be completely healed']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C2919405', 'cui_str': 'Tap water'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0427944', 'cui_str': 'Determination of bacterial growth'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",80.0,0.0639068,"On postoperative day seven, patients in Group O showed a significantly lower pain level than those in Group T (1.35±0.48 versus 2.40±0.9; p<0.001).","[{'ForeName': 'Joo Hyung', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Ajou University School of Medicine, 164 World cup-ro, Yeongtong-gu, Suwon, Gyeonggi-do 16499, Republic of Korea.'}, {'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Health Services Administration, University of Alabama at Birmingham 1720, 2nd Ave S, Birmingham, AL, 35294, US.'}, {'ForeName': 'Sae Yun', 'Initials': 'SY', 'LastName': 'Baik', 'Affiliation': 'Department of Laboratory Medicine, Seoul Clinical Laboratories, A-dong, Heungdok IT valley 13, Heungdeok 1-ro, Giheung-gu, Yongin, 16954, Republic of Korea.'}, {'ForeName': 'Yong Pyo', 'Initials': 'YP', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Hanvit Hospital, 1017 Gyeongsu-daero, Jangan-gu, Suwon, Gyeonggi-do 16300, Republic of Korea.'}]",Journal of wound care,['10.12968/jowc.2020.29.5.289']
2415,23241065,The Fit for Delivery study: rationale for the recommendations and test-retest reliability of a dietary score measuring adherence to 10 specific recommendations for prevention of excessive weight gain during pregnancy.,"Aiming at preventing excessive weight gain during pregnancy, 10 specific dietary recommendations are given to pregnant women in the intervention arm of the Norwegian Fit for Delivery (FFD) study. This paper presents the rationale and test-retest reliability of the food frequency questionnaire (FFQ) and a dietary score measuring adherence to the recommendations. The study is part of the ongoing FFD study, a randomised, controlled, intervention study in nulliparous pregnant women. A 43-item FFQ was developed for the FFD study. A dietary score was constructed from 10 subscales corresponding to the 10 dietary recommendations. Adding the subscales yielded a score from 0 to 10 with increasing score indicating healthier dietary behaviour. The score was divided into tertiles, grouping participants into low, medium and high adherence to the dietary recommendations. Pregnant women attending ultrasound screening at about week 19 of pregnancy were asked to complete the FFQ twice, 2 weeks apart. Of 154 pregnant women completing the first questionnaire, 106 (69%) completed the form on both occasions and was included in the study. The test-retest correlations of the score and subscales were r = 0.68 and r = 0.56-0.84, respectively (both P ≤ 0.001). There was 68% test-retest correct classification of the score and 70-87% of the subscales. In conclusion, acceptable test-retest reliability of the FFQ and the dietary score was found. The score will be used in the FFD study to measure adherence to the dietary recommendations throughout pregnancy and in the following year post-partum.",2015,"Pregnant women attending ultrasound screening at about week 19 of pregnancy were asked to complete the FFQ twice, 2 weeks apart.","['nulliparous pregnant women', 'Pregnant women attending ultrasound screening at about week 19 of pregnancy', '154 pregnant women completing the first questionnaire, 106 (69%) completed the form on both occasions and was included in the study']",['food frequency questionnaire (FFQ'],['excessive weight gain'],"[{'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0000765', 'cui_str': 'Excessive weight gain (finding)'}]",154.0,0.0253079,"Pregnant women attending ultrasound screening at about week 19 of pregnancy were asked to complete the FFQ twice, 2 weeks apart.","[{'ForeName': 'Nina C', 'Initials': 'NC', 'LastName': 'Øverby', 'Affiliation': 'Department of Public Health, Sports and Nutrition, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Elisabet R', 'Initials': 'ER', 'LastName': 'Hillesund', 'Affiliation': ''}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Sagedal', 'Affiliation': ''}, {'ForeName': 'Ingvild', 'Initials': 'I', 'LastName': 'Vistad', 'Affiliation': ''}, {'ForeName': 'Elling', 'Initials': 'E', 'LastName': 'Bere', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/mcn.12026']
2416,32421486,The effect of natural matrix biopolymer membrane on hard-to-heal venous leg ulcers: a pilot randomised clinical trial.,"OBJECTIVE


The aim of this study was to evaluate the therapeutic effects of natural matrix biopolymer membrane (NMBM) in the treatment of venous leg ulcers (VLUs).
METHOD


Patients exhibiting one or more VLU were assigned to a test group receiving NMBM or to a control group receiving conventional treatment. Patients exhibiting venous insufficiency-related ulcers within 0.1-170cm 2  were included. Efficacy was assessed based on ulcer size and visual analogue scale (VAS) pain scores at baseline and at weeks one, two and four. Ulcer size and pain were compared between groups using a two-way ANOVA.
RESULTS


In this study, 25 patients with 32 VLUs (NMBM group: 14 patients with 17 ulcers; control group: 11 patients with 15 ulcers) were included in the final analysis. At four weeks after baseline measurements, the mean percentage change in VLU area of patients in the NMBM group was 61.6% (95% CI: 40.3-82.9) compared with 84.1% (95% CI: 56.5-111.7) for control group patients. Additionally, the mean percentage change in VLU volume of NMBM group patients was 51.2% (95% CI: 31.8-70.6) compared with 84.0% (95% CI: 57.0-121.0) for control group patients. The NMBM group patients exhibited a mean decrease of 0.38 (95% CI: -0.85-1.61) in VAS pain score over four weeks, compared with a mean decrease of 0.13 (95% CI: -1.32-1.58) for control group patients. No significant differences in VLU area (p=0.210), volume (p=0.122) or VAS pain score (p=0.460) were shown between groups.
CONCLUSION


NMBM was found to be as effective and safe as the control group treatments. This pilot study suggests NMBM can be used safely to promote ulcer healing.",2020,"No significant differences in VLU area (p=0.210), volume (p=0.122) or VAS pain score (p=0.460) were shown between groups.
","['venous leg ulcers (VLUs', '25 patients with 32 VLUs (NMBM group: 14 patients with 17 ulcers; control group: 11 patients with 15 ulcers', 'Patients exhibiting one or more VLU', 'Patients exhibiting venous insufficiency-related ulcers within 0.1-170cm 2  were included', 'hard-to-heal venous leg ulcers']","['NMBM', 'natural matrix biopolymer membrane (NMBM', 'control group receiving conventional treatment', 'natural matrix biopolymer membrane']","['VLU volume', 'VAS pain score', 'effective and safe', 'Ulcer size and pain', 'VLU area (p=0.210), volume (p=0.122) or VAS pain score', 'Efficacy', 'ulcer size and visual analogue scale (VAS) pain scores']","[{'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0005554', 'cui_str': 'Biopolymer'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0042485', 'cui_str': 'Peripheral venous insufficiency'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0005554', 'cui_str': 'Biopolymer'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",25.0,0.0654363,"No significant differences in VLU area (p=0.210), volume (p=0.122) or VAS pain score (p=0.460) were shown between groups.
","[{'ForeName': 'Ziva', 'Initials': 'Z', 'LastName': 'Atias', 'Affiliation': 'Department of Dermatology, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Pederson', 'Affiliation': 'University of Minnesota: Twin Cities, Minneapolis, Minnesota, US.'}, {'ForeName': 'Hemant K', 'Initials': 'HK', 'LastName': 'Mishra', 'Affiliation': 'University of Minnesota: Twin Cities, Minneapolis, Minnesota, US.'}, {'ForeName': 'Shoshana', 'Initials': 'S', 'LastName': 'Greenberger', 'Affiliation': 'Department of Dermatology, Sheba Medical Center, Ramat Gan, Israel.'}]",Journal of wound care,['10.12968/jowc.2020.29.5.295']
2417,32422538,Short- and long-term changes in substance-related coping as mediators of in-person and computerized CBT for alcohol and drug use disorders.,"BACKGROUND


No studies have examined long-term changes in substance-related coping skills as a statistical mediator of cognitive-behavioral therapy (CBT) for substance use disorders (SUD).
METHODS


We tested both short- and long-term changes in coping as mediators of treatment effects in two trials of in-person and/or computerized CBT for SUD. The first trial included 137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in-person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU). The second trial included 68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following: CBT4CBT plus brief monitoring, CBT4CBT plus TAU, or TAU only. Coping was assessed with the Coping Strategies Scale. Latent growth curve mediational models were conducted, with both short-term (baseline through end-of-treatment) and long-term (baseline through 3-month post-treatment follow-up) changes in coping.
RESULTS


There were no mediation effects for short-term changes in coping. However, in both trials, there were significant mediation effects for long-term changes in coping: In trial 1, the effect of CBT4CBT vs. TAU on substance use at the 6-month follow-up was mediated by long-term increases in coping. This same mediation effect was not found for in-person CBT vs. TAU. In trial 2, the effect of CBT4CBT vs. not receiving CBT4CBT on heavy drinking at the 6-month follow-up was mediated by long-term increases in coping.
CONCLUSIONS


Long-term increases in coping may be a mechanism of change in computerized CBT for SUD.",2020,This same mediation effect was not found for in-person CBT vs. TAU.,"['68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following', 'two trials of in-person and/or computerized CBT for SUD', '137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in']","['CBT4CBT vs. TAU', 'CBT4CBT vs. not receiving CBT4CBT', 'person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU']","['coping', 'heavy drinking']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",137.0,0.0462548,This same mediation effect was not found for in-person CBT vs. TAU.,"[{'ForeName': 'Corey R', 'Initials': 'CR', 'LastName': 'Roos', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States. Electronic address: corey.roos@yale.edu.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Nich', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Frankforter', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kiluk', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108044']
2418,23020102,Effectiveness of an educational intervention to improve child feeding practices and growth in rural China: updated results at 18 months of age.,"Inappropriate complementary feeding practices have led to, in part, significant disparities in growth and nutritional status between rural and urban children in China. A cluster-randomised, controlled trial was implemented in Laishui, China to assess the effectiveness of an educational intervention on caregivers' feeding practices and children's growth. Eight townships were randomly assigned to the intervention or control. Five hundred ninety-nine healthy infants were enrolled at 2-4 months old, and were followed up at ages 6, 9, 12, 15 and 18 months. The intervention group received information on enhanced home-prepared recipes and food preparation and hygiene through group training, counselling and home visit. Key outcomes were children's physical growth, caregivers' knowledge and behaviours on complementary feeding, and the infant and child feeding index (ICFI). Analysis was by intention to treat. The intervention group achieved better knowledge and practices related to complementary feeding, and significantly higher ICFI scores at each follow-up point. Children in the intervention group achieved higher z-scores for weight-for-age (WAZ) and weight-for-height (WHZ) than the control (0.18 vs. 0.01 and 0.49 vs. 0.19, respectively) at 18 months old, and were less likely to have stunted growth (odds ratio = 0.71, 95% confidence interval: 0.53-0.94). Mixed model showed that the intervention group achieved significantly better linear growth over time, including WAZ (P = 0.016), WHZ (P = 0.030) and HAZ (P = 0.078). These results indicated that an educational intervention delivered through local health services can enhance caregivers' knowledge and practices of complementary feeding and ultimately improve children's growth.",2013,"The intervention group achieved better knowledge and practices related to complementary feeding, and significantly higher ICFI scores at each follow-up point.","['child feeding practices and growth in rural China', 'Eight townships', 'Five hundred ninety-nine healthy infants were enrolled at 2-4 months old, and were followed up at ages 6, 9, 12, 15 and 18 months', 'rural and urban children in China', ""caregivers' feeding practices and children's growth""]","['educational intervention', 'information on enhanced home-prepared recipes and food preparation and hygiene through group training, counselling and home visit']","['higher z-scores for weight-for-age (WAZ) and weight-for-height (WHZ', 'ICFI scores', 'linear growth over time, including WAZ', ""children's physical growth, caregivers' knowledge and behaviours on complementary feeding, and the infant and child feeding index (ICFI""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0424670', 'cui_str': 'Weight for height (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",599.0,0.0507959,"The intervention group achieved better knowledge and practices related to complementary feeding, and significantly higher ICFI scores at each follow-up point.","[{'ForeName': 'Jingxu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Child, Adolescent and Women's Health, School of Public Health, Peking University Health Science Center, Beijing, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Da-Fang', 'Initials': 'DF', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2012.00447.x']
2419,23230962,Social circumstances that drive early introduction of formula milk: an exploratory qualitative study in a peri-urban South African community.,"Breastfeeding is widely endorsed as the optimal strategy for feeding newborns and young infants, as well as improving child survival and achieving Millennium Development Goal 4. Exclusive breastfeeding (EBF) for the first 6 months of life is rarely practised in South Africa. Following the 2010 World Health Organization (WHO) infant feeding recommendations (EBF for HIV-positive mothers with maternal or infant antiretroviral treatment), South Africa adopted breastfeeding promotion as a National Infant Feeding Strategy and removed free formula milk from the Prevention of Mother-to-Child Transmission of HIV programme. This study aimed to explore the perceptions of mothers and household members at community level regarding the value they placed on formula feeding and circumstances that drive the practice in a peri-urban community. We conducted in-depth interviews with HIV-positive and HIV-negative mothers in a community-randomised trial (Good Start III). Focus group discussions were held with grandmothers, fathers and teenage mothers. Data were analysed using thematic analysis. The following themes were identified; inadequate involvement of teenage mothers; grandmothers who become replacement mothers; fear of failing to practise EBF for 6 months; partners as formula providers and costly formula milk leading to risky feeding practices. The new South African Infant Feeding Strategy needs to address the gaps in key health messages and develop community-orientated programmes with a focus on teenage mothers. These should encourage the involvement of grandmothers and fathers in decision-making about infant feeding so that they can support EBF for optimal child survival.",2014,The new South African Infant Feeding Strategy needs to address the gaps in key health messages and develop community-orientated programmes with a focus on teenage mothers.,"['teenage mothers; grandmothers who become replacement mothers; fear of failing to practise EBF for 6 months; partners as formula providers and costly formula milk leading to risky feeding practices', 'peri-urban South African community']","['formula milk', '2010 World Health Organization (WHO) infant feeding recommendations (EBF', 'Exclusive breastfeeding (EBF']",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0337474', 'cui_str': 'Grandmother'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0452742', 'cui_str': 'Formula milk (substance)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0452742', 'cui_str': 'Formula milk (substance)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}]",[],,0.0389939,The new South African Infant Feeding Strategy needs to address the gaps in key health messages and develop community-orientated programmes with a focus on teenage mothers.,"[{'ForeName': 'Petrida', 'Initials': 'P', 'LastName': 'Ijumba', 'Affiliation': ""Health Systems Research Unit, Medical Research Council, Durban, South Africa; International Maternal and Child Health (IMCH), Department of Women's and Children's Health, Uppsala, Sweden.""}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Doherty', 'Affiliation': ''}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'Lars-Åke', 'Initials': 'LÅ', 'LastName': 'Persson', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/mcn.12012']
2420,22909270,Oral magnesium for relief in pregnancy-induced leg cramps: a randomised controlled trial.,"Leg cramps are common in pregnant women. Currently, there is no standard treatment for pregnancy-induced leg cramps. The objective of this study was to evaluate the therapeutic efficacy of oral magnesium in pregnant women with leg cramps. This double-blinded, randomised, placebo-controlled trial included 86 healthy pregnant women, 14-34 weeks of gestation who had leg cramps at least twice per week. The study period was 4 weeks. Eighty women completed the study. Forty-one women were assigned to magnesium bisglycinate chelate (300 mg per day) and 39 women to placebo. Details of leg cramps were recorded before beginning the treatment and the fourth week of study. Outcome measure was the reduction of cramp frequency after treatment and cramp intensity measured by 100-mm visual analogue scale. Fifty per cent reduction of cramp frequency was significantly higher in the magnesium group than the placebo group (86.0% vs. 60.5%, P=0.007). The 50% reduction of cramp intensity was also significantly higher in the treatment group than in the placebo group (69.8% vs. 48.8%, P=0.048). There were no significant differences between the two groups in terms of side effects such as nausea and diarrhoea. These results demonstrated that oral magnesium supplement can improve the frequency and intensity of pregnancy-induced leg cramps. Therefore, oral magnesium may be a treatment option for women suffering from pregnancy-induced leg cramps.",2015,"Fifty per cent reduction of cramp frequency was significantly higher in the magnesium group than the placebo group (86.0% vs. 60.5%, P=0.007).","['Forty-one women', 'pregnant women', 'Eighty women completed the study', 'women suffering from pregnancy-induced leg cramps', 'pregnant women with leg cramps', '86 healthy pregnant women, 14-34 weeks of gestation who had leg cramps at least twice per week', 'pregnancy-induced leg cramps']","['placebo', 'magnesium bisglycinate chelate', 'oral magnesium', 'magnesium', 'Oral magnesium']","['side effects such as nausea and diarrhoea', 'cramp frequency', 'reduction of cramp frequency after treatment and cramp intensity measured by 100-mm visual analogue scale', 'therapeutic efficacy', 'leg cramps', 'Leg cramps', 'cramp intensity', 'frequency and intensity of pregnancy-induced leg cramps']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0023218', 'cui_str': 'Leg cramps'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1446787', 'cui_str': 'Cramping'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023218', 'cui_str': 'Leg cramps'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",86.0,0.525883,"Fifty per cent reduction of cramp frequency was significantly higher in the magnesium group than the placebo group (86.0% vs. 60.5%, P=0.007).","[{'ForeName': 'Chayanis', 'Initials': 'C', 'LastName': 'Supakatisant', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Pathumwan, Bangkok, 10330, Thailand.'}, {'ForeName': 'Vorapong', 'Initials': 'V', 'LastName': 'Phupong', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2012.00440.x']
2421,30956126,Correlates of Prenatal Diet Quality in Low-Income Hispanic Women.,"BACKGROUND


Low-income Hispanic women are at-risk of poor prenatal diet quality. Correlates associated with prenatal diet quality in this group of women are understudied.
OBJECTIVE


The objective of this study was to examine the associations between financial, cultural, psychosocial, and lifestyle correlates and prenatal diet quality in low-income Hispanic women.
DESIGN


This cross-sectional analysis used data from pregnant women enrolled in the Starting Early Trial, a randomized-controlled trial of a primary-care based child obesity prevention program beginning in pregnancy. The trial enrolled women from clinics affiliated with a large urban medical center in New York City from 2012 to 2014. Financial, cultural, psychosocial, and lifestyle variables were collected using a comprehensive baseline questionnaire. Usual dietary intakes over the past year were assessed using the Block Food Frequency Questionnaire 2005 bilingual version.
PARTICIPANTS


The study enrolled low-income Hispanic women between 28 and 32 gestational weeks (N=519).
MAIN OUTCOME MEASURES


Prenatal diet quality was measured by the Healthy Eating Index 2015.
STATISTICAL ANALYSES PERFORMED


Unadjusted and adjusted multivariable linear regression analyses were performed to determine independent associations between financial, cultural, psychosocial, and lifestyle correlates and Healthy Eating Index 2015 total score.
RESULTS


Overall prenatal diet quality was poor (mean Healthy Eating Index 2015 total score=69.0±9.4). Most women did not meet the maximum score for total vegetables (65.3%), whole grains (97.1%), dairy (74.8%), fatty acids (84.4%), refined grains (79.8%), sodium (97.5%), saturated fats (92.9%), and added sugars (66.5%). Women who reported screen time ≤2 hours/day, physical activity before and/or during pregnancy, and being born outside the United States had higher mean Healthy Eating Index 2015 total score than women with screen time >2 hours/day, no physical activity, and those born in the United States.
CONCLUSIONS


Prenatal diet quality of low-income pregnant Hispanic women was suboptimal. This cross-sectional study revealed associations between cultural and lifestyle factors and prenatal diet quality in low-income Hispanic women. Longitudinal studies are needed to determine long-term influences and specific behaviors to target for effective intervention studies.",2019,Overall prenatal diet quality was poor,"['Low-income Hispanic women', 'trial enrolled women from clinics affiliated with a large urban medical center in New York City from 2012 to 2014', 'Low-Income Hispanic Women', 'low-income Hispanic women', 'low-income pregnant Hispanic women', 'pregnant women enrolled in the Starting Early Trial', 'The study enrolled low-income Hispanic women between 28 and 32 gestational weeks (N=519']",['primary-care based child obesity prevention program'],"['financial, cultural, psychosocial, and lifestyle correlates and Healthy Eating Index 2015 total score', 'mean Healthy Eating Index 2015 total score', 'prenatal diet quality', 'screen time ≤2 hours/day, physical activity', 'financial, cultural, psychosocial, and lifestyle correlates and prenatal diet quality', 'Prenatal Diet Quality', 'fatty acids', 'Overall prenatal diet quality', 'Prenatal diet quality', 'maximum score for total vegetables', 'Financial, cultural, psychosocial, and lifestyle variables']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0556974', 'cui_str': 'hours/day (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",,0.0213256,Overall prenatal diet quality was poor,"[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Thomas Berube', 'Affiliation': ''}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Messito', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Woolf', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Deierlein', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.02.004']
2422,32422685,A randomized clinical trial of a group cognitive-behavioral therapy to reduce alcohol use among human immunodeficiency virus-infected out-patients in western Kenya.,"BACKGROUND AND AIMS


Culturally relevant and feasible interventions are needed to address limited professional resources in sub-Saharan Africa for behaviorally treating the dual epidemics of HIV and alcohol use disorder. This study tested the efficacy of a cognitive-behavioral therapy (CBT) intervention to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya.
DESIGN


Randomized clinical trial.
SETTING


A large HIV outpatient clinic in Eldoret, Kenya, affiliated with the Academic Model Providing Access to Healthcare collaboration.
PARTICIPANTS


A total of 614 HIV-infected outpatients (312 CBT; 302 HL; 48.5% male; mean age: 38.9 years; mean education 7.7 years) who reported a minimum of hazardous or binge drinking.
INTERVENTION AND COMPARATOR


A culturally adapted 6-session gender-stratified group CBT intervention compared with Healthy Lifestyles education (HL), each delivered by paraprofessionals over 6 weekly 90-minute sessions with a 9-month follow-up.
MEASUREMENTS


Primary outcome measures were percent drinking days (PDD) and mean drinks per drinking day (DDD) computed from retrospective daily number of drinks data obtained by use of the Timeline Followback from baseline through 9-months post-intervention. Exploratory analyses examined unprotected sex and number of partners.
FINDINGS


Median attendance was 6 sessions across condition. Retention was 85% through the 9-month follow-up. PDD and DDD marginal means were significantly lower in CBT than HL at all three study phases. Maintenance period: PDD-CBT 3.64 (0.70), HL 5.72 (0.71), mean difference 2.08 (95% CI 0.13-4.04); DDD-CBT 0.66 (0.10) HL 0.98 (0.10), mean difference 0.31 (95% CI 0.05-0.58). Risky sex decreased over time in both conditions, with a temporary effect for CBT at the 1-month follow-up.
CONCLUSIONS


A cognitive-behavioral therapy intervention was more efficacious than Healthy Lifestyles education in reducing alcohol use among HIV-infected Kenyan outpatient drinkers.",2020,"Risky sex decreased over time in both conditions, with a temporary effect for CBT at the 1-month follow-up.
","['A total of 614 HIV-infected outpatients (312 CBT; 302 HL; 48.5% male; mean age: 38.9 years; mean education 7.7 years) who reported a minimum of hazardous or binge drinking', 'HIV-infected Kenyan outpatient drinkers', 'HIV-infected outpatients in Eldoret, Kenya', 'A large HIV outpatient clinic in Eldoret, Kenya, affiliated with the Academic Model Providing Access to Healthcare collaboration', 'human immunodeficiency virus-infected out-patients in western Kenya']","['CBT intervention compared with Healthy Lifestyles education (HL', 'cognitive-behavioral therapy intervention', 'cognitive-behavioral therapy (CBT) intervention', 'group cognitive-behavioral therapy']","['Risky sex', 'PDD and DDD marginal means', 'percent drinking days (PDD) and mean drinks per drinking day (DDD) computed from retrospective daily number of drinks data obtained by use of the Timeline Followback']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}]",614.0,0.0372522,"Risky sex decreased over time in both conditions, with a temporary effect for CBT at the 1-month follow-up.
","[{'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Papas', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Benson N', 'Initials': 'BN', 'LastName': 'Gakinya', 'Affiliation': 'Moi University College of Health Sciences, School of Medicine, Eldoret, Kenya.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Mwaniki', 'Affiliation': 'Academic Model providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Keter', 'Affiliation': 'Academic Model providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Klein', 'Affiliation': 'Right Response LLC, Minneapolis, MN, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Michelle P', 'Initials': 'MP', 'LastName': 'Loxley', 'Affiliation': 'Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Sidle', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Schlaudt', 'Affiliation': 'Lutheran World Foundation, Gore, Chad.'}, {'ForeName': 'Tobista', 'Initials': 'T', 'LastName': 'Nafula', 'Affiliation': 'Academic Model providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Omodi', 'Affiliation': 'Academic Model providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Joyce B', 'Initials': 'JB', 'LastName': 'Baliddawa', 'Affiliation': 'Moi University College of Health Sciences, School of Medicine, Eldoret, Kenya.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Kinyanjui', 'Affiliation': 'Moi University College of Health Sciences, School of Medicine, Eldoret, Kenya.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'Lutheran World Foundation, Gore, Chad.'}]","Addiction (Abingdon, England)",['10.1111/add.15112']
2423,32422871,The Psychological Effects of a Campus Forest Therapy Program.,"This study aimed to examine the psychological effects of a campus forest therapy program. To evaluate these, pre-test and post-test control group design was employed. A total of 38 participants participated in this study (19 in the campus forest therapy program group, and 19 in control). The Profile of Mood State (POMS) questionnaire and Modified form of the Stress Response Inventory (SRI-MF) were administered to each participant to assess psychological effects. The results of this study revealed that participants in the campus forest therapy program group had significantly positive increases in their mood and stress response compared with those of control group participants. In conclusion, the campus forest therapy program is an efficient strategy to provide psychological health benefits to university students and our study can inform decision-makers on the priority of the campus forest program in societal efforts to promote psychological well-being among university students.",2020,The Profile of Mood State (POMS) questionnaire and Modified form of the Stress Response Inventory (SRI-MF) were administered to each participant to assess psychological effects.,"['university students', '38 participants participated in this study (19 in the campus forest therapy program group, and 19 in control']",[],"['mood and stress response', 'Profile of Mood State (POMS) questionnaire and Modified form of the Stress Response Inventory (SRI-MF']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",38.0,0.0197324,The Profile of Mood State (POMS) questionnaire and Modified form of the Stress Response Inventory (SRI-MF) were administered to each participant to assess psychological effects.,"[{'ForeName': 'Jin Gun', 'Initials': 'JG', 'LastName': 'Kim', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Tae Gyu', 'Initials': 'TG', 'LastName': 'Khil', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Youngsuwn', 'Initials': 'Y', 'LastName': 'Lim', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Kyungja', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Minja', 'Initials': 'M', 'LastName': 'Shin', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Won Sop', 'Initials': 'WS', 'LastName': 'Shin', 'Affiliation': 'Department of Forest Sciences, Chungbuk National University, Cheongju 28644, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17103409']
2424,32421513,Adolescents' Acceptance of Long-Acting Reversible Contraception After an Educational Intervention in the Emergency Department: A Randomized Controlled Trial.,"INTRODUCTION


Adolescents who seek care in the emergency department (ED) are a cohort at increased risk of unintended pregnancy. Although adolescents are interested in learning about pregnancy prevention in the ED, there is a lack of effective educational interventions in this setting. Long-acting reversible contraceptives (LARC) are highly effective and safe in teens, yet are underutilized. This study assessed contraception use among adolescents in the ED and evaluated the impact of an educational video on their interest in and uptake of LARCs.
METHODS


We conducted a two-arm randomized controlled trial on a convenience sample of sexually active females 14 to 21 years old in an urban pediatric ED. Participants were randomized to an educational video or standard care. All participants completed a survey and were given an informational card about affiliated teen clinics with the option to schedule an appointment. We assessed pre-post mean differences between control and intervention participants and pre-post differences among intervention participants. Participants were followed three months after their ED visit to examine use of contraception.
RESULTS


A total of 79 females were enrolled (42 control and 37 intervention). The mean age was 17 years, and most were youth of color. The proportion of participants with a prior pregnancy was 18%. Almost all participants reported wanting to avoid pregnancy, yet 18% reported not using contraception at last intercourse. At baseline, 17.7% of participants were somewhat or very interested in the intrauterine device (IUD) or implant. After watching the video, 42.3% were somewhat or very interested in the IUD and 35.7% in the implant. Among those who watched the video, there were significant increases in interest in using an IUD or implant (p<.001). Compared to controls, adolescents who watched the video were also significantly more likely to report wanting an IUD (p<0.001) or implant (p=0.002). A total of 46% were reached for follow-up. Of these, 16% had initiated a LARC method after their ED visit (p=NS).
CONCLUSION


Most adolescent females in the ED want to avoid pregnancy, but are using ineffective methods of contraception. A brief educational video on LARCs was acceptable to adolescents and feasible to implement in a busy urban ED setting. Adolescents who watched the video had significantly greater interest in using LARCs, but no demonstrated change in actual adoption of contraception.",2020,"Adolescents who watched the video had significantly greater interest in using LARCs, but no demonstrated change in actual adoption of contraception.","['The mean age was 17 years, and most were youth of color', 'A total of 79 females were enrolled (42 control and 37 intervention', 'convenience sample of sexually active females 14 to 21 years old in an urban pediatric ED', 'Adolescents who seek care in the emergency department (ED']","['educational video or standard care', 'Long-acting reversible contraceptives (LARC', 'Educational Intervention']","['actual adoption of contraception', 'report wanting an IUD', 'wanting to avoid pregnancy', ""Adolescents' Acceptance of Long-Acting Reversible Contraception""]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C4505307', 'cui_str': 'Long-Acting Reversible Contraception'}]",79.0,0.153725,"Adolescents who watched the video had significantly greater interest in using LARCs, but no demonstrated change in actual adoption of contraception.","[{'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Vayngortin', 'Affiliation': ""Rady Children's Hospital, University of California San Diego, Division of Emergency Medicine, San Diego, California.""}, {'ForeName': 'Lela', 'Initials': 'L', 'LastName': 'Bachrach', 'Affiliation': ""University of California San Francisco Benioff Children's Hospital Oakland, Department of Adolescent Medicine, Oakland, California.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': ""University of California San Francisco Benioff Children's Hospital Oakland, Department of Emergency Medicine, Oakland, California.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Tebb', 'Affiliation': 'University of California San Francisco, Department of Adolescent Medicine, San Francisco, California.'}]",The western journal of emergency medicine,['10.5811/westjem.2020.2.45433']
2425,32421593,Familial severe psychiatric history in bipolar disorder and correlation with disease severity and treatment response.,"BACKGROUND


Bipolar disorder is a heritable disorder, and we aimed to assess the impact of family history of mental disorders in first-degree relatives on the severity and course of bipolar disorder.
METHODS


The Bipolar CHOICE (lithium versus quetiapine) and LiTMUS (optimized treatment with versus without lithium) comparative effectiveness studies were similar trials among bipolar disorder outpatients studying four different randomized treatment arms for 24 weeks. Patients self-reported on six severe mental disorders among first-degree relatives. We performed ANOVA and linear regression regarding disease severity measures, sociodemographic and cardiometabolic markers and mixed effects linear regression to evaluate treatment response.
RESULTS


Among 757 patients, 644 (85.1%) reported at least one first-degree relative with a severe mental disorder (mean=2.8; standard deviation=2.2; range=0-13). Depression (67.1%), alcohol abuse (51.0%) and bipolar disorder (47.0%) were the most frequently reported disorders. Familial psychiatric history correlated with several disease severity measures (hospitalizations, suicide attempts, and earlier onset) and sociodemographic markers (lower education and household income) but not with cardiometabolic markers (e.g. cholesterol or waist circumference) or cardiovascular risk scores, e.g. the Framingham risk score. Patients with familial psychiatric history tended to require more psychopharmacological treatment (p=0.054) but responded similarly (all p>0.1) to all four treatment arms.
CONCLUSIONS


Our findings indicate that familial psychiatric history is common among outpatients with bipolar disorder and correlates with disease severity and sociodemographic measures. Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.",2020,Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.,"['Patients with familial psychiatric history', 'bipolar disorder outpatients', 'outpatients with bipolar disorder']",['Bipolar CHOICE (lithium versus quetiapine) and LiTMUS (optimized treatment with versus without lithium'],"['severe mental disorder', 'Depression', 'cardiometabolic markers (e.g. cholesterol or waist circumference) or cardiovascular risk scores, e.g. the Framingham risk score', 'bipolar disorder', 'alcohol abuse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse'}]",757.0,0.044469,Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.,"[{'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Köhler-Forsberg', 'Affiliation': 'Psychosis Research Unit, Aarhus University Hospital Psychiatry, Denmark; Department of Clinical Medicin, Aarhus University, Aarhus, Denmark; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: karkoe@rm.dk.'}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Ruberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Kuperberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alec P', 'Initials': 'AP', 'LastName': 'Shannon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Fung', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital; Department of Medicine, Harvard Medical School.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Overhage', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Bowden', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Science Center, Albuquerque, NM, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kocsis', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Terence A', 'Initials': 'TA', 'LastName': 'Ketter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Friedman', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McElroy', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH and Lindner Center of HOPE, Mason, OH, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ostacher', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.157']
2426,23241449,"Early invitation to food and/or multiple micronutrient supplementation in pregnancy does not affect body composition in offspring at 54 months: follow-up of the MINIMat randomised trial, Bangladesh.","Growth patterns in early life are associated with later health. The effect of nutrition during in utero development on later body composition is unclear. We evaluated whether prenatal early invitation to food and/or multiple micronutrient supplementation (MMS) in pregnancy has an effect on offspring body composition at 54 months of age. In Maternal and Infant Nutrition Interventions in Matlab trial (ISRCTN16581394) in Bangladesh, 4436 pregnant women were randomised into six equally sized groups: double-masked supplementation with capsules of either 30 mg Fe and 400 μg folic acid, or 60 mg Fe and 400 μg folic acid, or MMS (15 micronutrients), was combined with a randomised early invitation (around 9 weeks) or a usual invitation (around 20 weeks) to start food supplementation (608 kcal 6 days per week). At 54 months, the body composition of the offspring was assessed by leg-to-leg bioelectrical impedance analysis. Of the 3267 live singletons with birth anthropometry, 2290 children were measured at 54 months, representing 70% of the live births. There was no interaction between the food and micronutrient supplementation on body composition outcomes. There were no significant differences in a range of anthropometric and body composition measurements, including weight, height, mid-upper arm circumference, head circumference, skinfold thickness, and fat mass and fat-free mass between the different prenatal food and micronutrient groups using an intention-to-treat analysis. This analysis shows that early invitation to food supplementation and MMS provided to rural Bangladeshi women during pregnancy did not affect offspring body composition at 54 months of age.",2015,"There were no significant differences in a range of anthropometric and body composition measurements, including weight, height, mid-upper arm circumference, head circumference, skinfold thickness, and fat mass and fat-free mass between the different prenatal food and micronutrient groups using an intention-to-treat analysis.","['Bangladesh, 4436 pregnant women', '3267 live singletons with birth anthropometry, 2290 children']","['prenatal early invitation to food and/or multiple micronutrient supplementation (MMS', 'double-masked supplementation with capsules of either 30\u2009mg Fe and 400\u2009μg folic acid, or 60\u2009mg Fe and 400\u2009μg folic acid, or MMS (15 micronutrients), was combined with a randomised early invitation (around 9 weeks) or a usual invitation (around 20 weeks) to start food supplementation', 'food and/or multiple micronutrient supplementation']","['body composition outcomes', 'body composition', 'range of anthropometric and body composition measurements, including weight, height, mid-upper arm circumference, head circumference, skinfold thickness, and fat mass and fat-free mass']","[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference (observable entity)'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}]",4436.0,0.241592,"There were no significant differences in a range of anthropometric and body composition measurements, including weight, height, mid-upper arm circumference, head circumference, skinfold thickness, and fat mass and fat-free mass between the different prenatal food and micronutrient groups using an intention-to-treat analysis.","[{'ForeName': 'Ashraful Islam', 'Initials': 'AI', 'LastName': 'Khan', 'Affiliation': ""International Maternal and Child Health, Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Kabir', 'Affiliation': 'International Centre for Diarrhoeal Diseases Research, Bangladesh (ICDDR,B), Dhaka, Bangladesh.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hawkesworth', 'Affiliation': 'Medical Research Council International Nutrition Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Eva-Charlotte', 'Initials': 'EC', 'LastName': 'Ekström', 'Affiliation': ""International Maternal and Child Health, Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Shams', 'Initials': 'S', 'LastName': 'Arifeen', 'Affiliation': 'International Centre for Diarrhoeal Diseases Research, Bangladesh (ICDDR,B), Dhaka, Bangladesh.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Frongillo', 'Affiliation': 'Department of Health Promotion, Education and Behavior, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, USA.'}, {'ForeName': 'Lars Åke', 'Initials': 'LÅ', 'LastName': 'Persson', 'Affiliation': ""International Maternal and Child Health, Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}]",Maternal & child nutrition,['10.1111/mcn.12021']
2427,32422597,The Influence of Fitness-App Usage on Psychological Well-Being and Body Awareness-A Daily Diary Randomized Trial.,"Self-tracking via fitness apps is popular and has been described as a means to enhance body awareness and well-being. However, the effects of fitness-app use and specific app functions on well-being and body awareness have yet to be targeted in controlled experimental studies. In two randomized groups, a fitness tracker was used for 6 weeks, and in one group a daily step target was implemented. In a third control group, participants documented their physical activity. A daily diary method was used to measure well-being and body trusting. In Bayesian multilevel analyses, no time, group, or interaction effects were found. These results were robust when controlling for diverse variables. It can be concluded that exercise-related self-tracking and specific step goals do not substantially influence psychological well-being and body trusting. Considering the large variability in effects, potential effects can be assumed under conditions that are to be identified in further studies.",2020,It can be concluded that exercise-related self-tracking and specific step goals do not substantially influence psychological well-being and body trusting.,[],[],"['Psychological Well-Being and Body Awareness', 'physical activity']",[],[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0161173,It can be concluded that exercise-related self-tracking and specific step goals do not substantially influence psychological well-being and body trusting.,"[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Busch', 'Affiliation': 'University of Münster.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Utesch', 'Affiliation': 'University of Münster.'}, {'ForeName': 'Paul-Christian', 'Initials': 'PC', 'LastName': 'Bürkner', 'Affiliation': 'University of Münster.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Strauss', 'Affiliation': 'University of Münster.'}]",Journal of sport & exercise psychology,['10.1123/jsep.2019-0315']
2428,23020135,Early growth velocities and weight gain plasticity improve linear growth in Peruvian infants.,"Growth velocity patterns have the potential to signal unhealthy responses to environmental insults with long-term consequences. We aimed to investigate velocities in Peruvian infants (n = 259) in relation to attained anthropometric outcomes at 12 months and to identify determinants of velocities during critical periods of infancy. From 1995 to 1997, a randomised controlled trial of maternal zinc supplementation was conducted in a peri-urban slum area of Lima. Infants were followed monthly through 1 year on a range of anthropometric measures. Three types of velocity variables were studied: (1) incremental velocity (1 months and 3 months); (2) proportional changes (% of total size gained/month); and (3) individual velocity variability [standard deviation (SD) of individual child incremental velocities]. Mean individual child SD of weight velocity was 417 g (±126). In multivariate ordinary least squares regression analyses, growth velocities in month 1 and individual weight velocity variability positively predicted attained length and weight by 12 months. Panel regression by generalised least-squares with random effects of length and weight velocities confirmed the exponentially decelerating pace of growth through infancy and the importance of birth size in driving this trajectory. This study contributes evidence to support the importance of early growth velocities and greater degrees of weight gain plasticity for attained length and weight.",2015,Panel regression by generalised least-squares with random effects of length and weight velocities confirmed the exponentially decelerating pace of growth through infancy and the importance of birth size in driving this trajectory.,"['peri-urban slum area of Lima', 'Peruvian infants', 'Peruvian infants (n\u2009=\u2009259']",['maternal zinc supplementation'],"['Mean individual child SD of weight velocity', 'individual velocity variability [standard deviation (SD) of individual child incremental velocities']","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0455808', 'cui_str': 'Weight velocity (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",,0.032085,Panel regression by generalised least-squares with random effects of length and weight velocities confirmed the exponentially decelerating pace of growth through infancy and the importance of birth size in driving this trajectory.,"[{'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Iannotti', 'Affiliation': 'Institute for Public Health, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Zavaleta', 'Affiliation': ''}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Huasaquiche', 'Affiliation': ''}, {'ForeName': 'Zulema', 'Initials': 'Z', 'LastName': 'Leon', 'Affiliation': ''}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Caulfield', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2012.00453.x']
2429,32421521,Efficacy of Laryngeal Tube versus Bag Mask Ventilation by Inexperienced Providers.,"INTRODUCTION


Bag mask ventilation (BMV) and extraglottic devices (EGDs) are two common methods of providing rescue ventilation. BMV can be difficult to perform effectively, especially for inexperienced providers and in patients with difficult airway characteristics. There is some evidence that the laryngeal tube (LT) can be successfully placed by inexperienced providers to provide effective ventilation. However, it is unclear whether ventilation provided by LT is superior to that of BMV, especially in the hands of inexperienced airway providers. Therefore, we aimed to compare ventilation efficacy of inexperienced airway providers with BMV versus LT by primarily measuring tidal volumes and secondarily measuring peak pressures on a simulated model.
METHODS


We performed a crossover study first year emergency medicine residents and third and fourth year medical students. After a brief instructional video followed by hands on practice, participants performed both techniques in random order on a simulated model for two minutes each. Returned tidal volumes and peak pressures were measured.
RESULTS


Twenty participants were enrolled and 1200 breaths were measured, 600 per technique. The median ventilation volumes were 194 milliliters (mL) for BMV, and 387 mL for the laryngeal tube, with a median absolute difference of 170 mL (95% confidence interval [CI] 157-182 mL) (mean difference 148 mL [95% CI, 138-158 mL], p<0.001). The median ventilation peak pressures were 23 centimeters of water (cm H 2 O) for BMV, and 30 cm H 2 O for the laryngeal tube, with a median absolute difference of 7 cm H 2 O (95% CI, 6-8 cm H2O) (mean difference 8 cm H 2 O [95% CI, 7-9 cm H 2 O], p<0.001).
CONCLUSION


Inexperienced airway providers were able to provide higher ventilation volumes and peak pressures with the LT when compared to BMV in a manikin model. Inexperienced providers should consider using an LT when providing rescue ventilations in obtunded or hypoventilating patients without intact airway reflexes. Further study is required to understand whether these findings are generalizable to live patients.",2020,Inexperienced airway providers were able to provide higher ventilation volumes and peak pressures with the LT when compared to BMV in a manikin model.,"['year emergency medicine residents and third and fourth year medical students', 'Twenty participants were enrolled and 1200 breaths were measured, 600 per technique']","['BMV', 'Laryngeal Tube versus Bag Mask Ventilation', 'Bag mask ventilation (BMV) and extraglottic devices (EGDs', 'BMV versus LT']","['median ventilation volumes', 'median ventilation peak pressures', 'Returned tidal volumes and peak pressures', 'ventilation efficacy']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",20.0,0.113979,Inexperienced airway providers were able to provide higher ventilation volumes and peak pressures with the LT when compared to BMV in a manikin model.,"[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hart', 'Affiliation': 'Hennepin Healthcare, Department of Emergency Medicine, Minneapolis, Minnesota.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Driver', 'Affiliation': 'Hennepin Healthcare, Department of Emergency Medicine, Minneapolis, Minnesota.'}, {'ForeName': 'Gautham', 'Initials': 'G', 'LastName': 'Kartha', 'Affiliation': 'Hennepin Healthcare, Department of Emergency Medicine, Minneapolis, Minnesota.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Reardon', 'Affiliation': 'Hennepin Healthcare, Department of Emergency Medicine, Minneapolis, Minnesota.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Miner', 'Affiliation': 'Hennepin Healthcare, Department of Emergency Medicine, Minneapolis, Minnesota.'}]",The western journal of emergency medicine,['10.5811/westjem.2020.3.45844']
2430,23020829,"A pragmatic randomised controlled trial on routine iron prophylaxis during pregnancy in Maputo, Mozambique (PROFEG): rationale, design, and success.","The effects of prophylactic iron during pregnancy on maternal and child health in developing settings with endemic malaria and high prevalence of HIV remain unclear. This paper describes the rationale, implementation and success of a pragmatic randomised controlled trial comparing routine iron supplementation vs. screening and treatment for anaemia during pregnancy. The setting was two health centres in Maputo, Mozambique. Pregnant women (≥ 12-week gestation; ≥ 18 years old; and not with a high-risk pregnancy, n=4326) were recruited. The main outcomes are preterm delivery and low birthweight. The women were randomly assigned to one of two iron administration policies: a routine iron group (n=2184) received 60 mg of ferrous sulphate plus 400 μg of folic acid daily while a selective iron group (n=2142) had screening and treatment for anaemia and a daily intake of 1 mg of folic acid. The recruitment, follow-up, and collection of follow-up data were successful; both groups were similar to each other in all the trial stages. Collection of delivery data was challenging and data on about 40% of births is missing. These are currently being traced through different hospitals and health centres. The compliance of the study personnel and the women with regard to regular measurement of haemoglobin and intake of the iron and folic acid tablets was high and similar in both trial arms. Taking into account the various constraints encountered, the stages of the present trial prior to delivery were carried out well.",2015,"The recruitment, follow-up, and collection of follow-up data were successful; both groups were similar to each other in all the trial stages.","['Pregnant women (≥ 12-week gestation; ≥ 18 years old; and not with a high-risk pregnancy, n=4326) were recruited', 'anaemia during pregnancy']","['routine iron prophylaxis', 'iron administration policies: a routine iron group (n=2184) received 60 mg of ferrous sulphate plus 400 μg of folic acid daily while a selective iron group (n=2142) had screening and treatment for anaemia and a daily intake of 1 mg of folic acid', 'routine iron supplementation vs. screening and treatment']","['preterm delivery and low birthweight', 'haemoglobin and intake of the iron and folic acid tablets']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0242786', 'cui_str': 'High-Risk Pregnancy'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0580106', 'cui_str': 'Prophylactic iron therapy (procedure)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]",4326.0,0.248481,"The recruitment, follow-up, and collection of follow-up data were successful; both groups were similar to each other in all the trial stages.","[{'ForeName': 'Bright I', 'Initials': 'BI', 'LastName': 'Nwaru', 'Affiliation': 'School of Health Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Saara', 'Initials': 'S', 'LastName': 'Parkkali', 'Affiliation': ''}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Abacassamo', 'Affiliation': ''}, {'ForeName': 'Graca', 'Initials': 'G', 'LastName': 'Salomé', 'Affiliation': ''}, {'ForeName': 'Baltazar', 'Initials': 'B', 'LastName': 'Chilundo', 'Affiliation': ''}, {'ForeName': 'Orvalho', 'Initials': 'O', 'LastName': 'Augusto', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cliff', 'Affiliation': ''}, {'ForeName': 'Martinho', 'Initials': 'M', 'LastName': 'Dgedge', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Regushevskaya', 'Affiliation': ''}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Nikula', 'Affiliation': ''}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Hemminki', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/mcn.12006']
2431,32422942,The Effect of Ursodeoxycholic Acid on Small Intestinal Bacterial Overgrowth in Patients with Functional Dyspepsia: A Pilot Randomized Controlled Trial.,"Functional dyspepsia (FD) is associated with small intestinal bacterial overgrowth (SIBO). Several animal studies have reported that ursodeoxycholic acid (UDCA) has antibacterial and anti-inflammatory effects in the intestine. We hypothesized that UDCA may be effective against dyspeptic symptoms and SIBO in patients with FD. We conducted this randomized controlled trial to investigate the effects of UDCA in FD patients with SIBO. Twenty-four patients diagnosed with FD and SIBO based on lactulose breath test (LBT) were randomly assigned to either a UDCA treatment group or an untreated group. The treatment group received 100 mg of UDCA three times per day for two months; the untreated group was monitored for two months without intervention. After two months in both groups, we reevaluated LBT and FD symptoms using the Nepean dyspepsia index-K. FD symptoms in the UDCA-treated group were significantly reduced after two months compared with baseline and FD symptom scores between the UDCA-treated and untreated groups showed statistically significant differences after two months. In addition, the total methane gas levels for 90 minutes in LBT were significantly decreased after two months compared with baseline in the UDCA-treated group. In this preliminary exploratory study, we found that two months of UDCA treatment resulted in FD symptom improvement and reduced methane values during 90 minutes on the LBT, suggesting that methane-producing SIBO were associated with symptoms of dyspepsia and that UDCA was helpful in these patients. These findings need to be validated via large-scale controlled and well-designed studies.",2020,"In addition, the total methane gas levels for 90 minutes in LBT were significantly decreased after two months compared with baseline in the UDCA-treated group.","['Twenty-four patients diagnosed with FD and SIBO based on lactulose breath test (LBT', 'FD patients with SIBO', 'Patients with Functional Dyspepsia', 'patients with FD']","['UDCA treatment group or an untreated group', 'Ursodeoxycholic Acid', 'ursodeoxycholic acid (UDCA', 'UDCA']","['FD symptom improvement and reduced methane values', 'Functional dyspepsia (FD', 'Small Intestinal Bacterial Overgrowth', 'LBT and FD symptoms using the Nepean dyspepsia index-K. FD symptoms', 'total methane gas levels', 'FD symptom scores']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C3160854', 'cui_str': 'Small intestinal bacterial overgrowth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0025617', 'cui_str': 'Methane'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3160854', 'cui_str': 'Small intestinal bacterial overgrowth'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",24.0,0.0623256,"In addition, the total methane gas levels for 90 minutes in LBT were significantly decreased after two months compared with baseline in the UDCA-treated group.","[{'ForeName': 'Bom-Taeck', 'Initials': 'BT', 'LastName': 'Kim', 'Affiliation': 'Department of Family Practice and Community Health, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Kwang-Min', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Department of Family Practice and Community Health, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Kyu-Nam', 'Initials': 'KN', 'LastName': 'Kim', 'Affiliation': 'Department of Family Practice and Community Health, Ajou University School of Medicine, Suwon 16499, Korea.'}]",Nutrients,['10.3390/nu12051410']
2432,22727783,Craving as a predictor of treatment outcomes in heavy drinkers with comorbid depressed mood.,"Alcohol and depression comorbidity is high and is associated with poorer outcomes following treatment. The ability to predict likely treatment response would be advantageous for treatment planning. Craving has been widely studied as a potential predictor, but has performed inconsistently. The effect of comorbid depression on craving's predictive performance however, has been largely neglected, despite demonstrated associations between negative affect and craving. The current study examined the performance of craving, measured pre-treatment using the Obsessive subscale of the Obsessive Compulsive Drinking Scale, in predicting 18-week and 12-month post-treatment alcohol use outcomes in a sample of depressed drinkers. Data for the current study were collected during a randomized controlled trial (Baker, Kavanagh, Kay-Lambkin, Hunt, Lewin, Carr, & Connolly, 2010) comparing treatments for comorbid alcohol and depression. A subset of 260 participants from that trial with a Timeline Followback measure of alcohol consumption was analyzed. Pre-treatment craving was a significant predictor of average weekly alcohol consumption at 18 weeks and of frequency of alcohol binges at 18 weeks and 12 months, but pre-treatment depressive mood was not predictive, and effects of Baseline craving were independent of depressive mood. Results suggest a greater ongoing risk from craving than from depressive mood at Baseline.",2013,"treatment craving was a significant predictor of average weekly alcohol consumption at 18 weeks and of frequency of alcohol binges at 18 weeks and 12 months, but pre-treatment depressive mood was not predictive, and effects of Baseline craving were independent of depressive mood.","['260 participants from that trial with a Timeline Followback measure of alcohol consumption was analyzed', 'heavy drinkers with comorbid depressed mood']",[],"['frequency of alcohol binges', 'average weekly alcohol consumption', 'Obsessive subscale of the Obsessive Compulsive Drinking Scale']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}]",[],"[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0556346', 'cui_str': 'Binge Drinking'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0222045'}]",,0.0267832,"treatment craving was a significant predictor of average weekly alcohol consumption at 18 weeks and of frequency of alcohol binges at 18 weeks and 12 months, but pre-treatment depressive mood was not predictive, and effects of Baseline craving were independent of depressive mood.","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Connolly', 'Affiliation': 'Institute of Health and Biomedical Innovation and School of Psychology and Counselling, Queensland University of Technology, Australia. Electronic address: jennifer.connolly@qut.edu.au.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kavanagh', 'Affiliation': 'Institute of Health and Biomedical Innovation and School of Psychology and Counselling, Queensland University of Technology, Australia.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Baker', 'Affiliation': 'Centre for Brain and Mental Health Research, The University of Newcastle, Australia.'}, {'ForeName': 'Frances J', 'Initials': 'FJ', 'LastName': 'Kay-Lambkin', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Australia.'}, {'ForeName': 'Terry J', 'Initials': 'TJ', 'LastName': 'Lewin', 'Affiliation': 'Hunter New England Mental Health, New South Wales Department of Health, Australia.'}, {'ForeName': 'Penelope J', 'Initials': 'PJ', 'LastName': 'Davis', 'Affiliation': 'School of Applied Psychology and Griffith Health Institute, Griffith University, Australia.'}, {'ForeName': 'Lake-Hui', 'Initials': 'LH', 'LastName': 'Quek', 'Affiliation': 'Centre for Youth Substance Abuse Research, The University of Queensland, Australia.'}]",Addictive behaviors,['10.1016/j.addbeh.2012.06.003']
2433,22735030,Effects of dietary counselling on food habits and dietary intake of Finnish pregnant women at increased risk for gestational diabetes - a secondary analysis of a cluster-randomized controlled trial.,"The incidence of gestational diabetes mellitus (GDM) is increasing and GDM might be prevented by improving diet. Few interventions have assessed the effects of dietary counselling on dietary intake of pregnant women. This study examined the effects of dietary counselling on food habits and dietary intake of Finnish pregnant women as secondary outcomes of a trial primarily aiming at preventing GDM. A cluster-randomized controlled trial was conducted in 14 municipalities in Finland, including 399 pregnant women at increased risk for developing GDM. The intervention consisted of dietary counselling focusing on dietary fat, fibre and saccharose intake at four routine maternity clinic visits. Usual counselling practices were continued in the usual care municipalities. A validated 181-item food frequency questionnaire was used to assess changes in diet from baseline to 26-28 and 36-37 weeks gestation. The data were analysed using multilevel mixed-effects linear regression models. By 36-37 weeks gestation, the intervention had beneficial effects on total intake of vegetables, fruits and berries (coefficient for between-group difference in change 61.6 g day(-1), 95% confidence interval 25.7-97.6), the proportions of high-fibre bread of all bread (7.2% units, 2.5-11.9), low-fat cheeses of all cheeses (10.7% units, 2.6-18.9) and vegetable fats of all dietary fats (6.1% -units, 2.0-10.3), and the intake of saturated fatty acids (-0.67 energy-%-units, -1.16 to -0.19), polyunsaturated fatty acids (0.38 energy-%-units, 0.18-0.58), linoleic acid (764 mg day(-1), 173-1354) and fibre (2.07 g day(-1) , 0.39-3.75). The intervention improved diet towards the recommendations in pregnant women at increased risk for GDM suggesting the counselling methods could be implemented in maternity care.",2014,The intervention improved diet towards the recommendations in pregnant women at increased risk for GDM suggesting the counselling methods could be implemented in maternity care.,"['pregnant women', '14 municipalities in Finland, including 399 pregnant women at increased risk for developing GDM', 'Finnish pregnant women at increased risk for gestational diabetes ', 'Finnish pregnant women']","['dietary counselling', 'linoleic acid', 'dietary counselling focusing on dietary fat, fibre and saccharose intake']","['total intake of vegetables, fruits and berries (coefficient', 'food habits and dietary intake', 'intake of saturated fatty acids', 'polyunsaturated fatty acids', 'gestational diabetes mellitus (GDM']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0600182'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0023750', 'cui_str': 'Linoleic Acids'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0012171', 'cui_str': 'Dietary Fats'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0005135', 'cui_str': 'Berries'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}]",399.0,0.152796,The intervention improved diet towards the recommendations in pregnant women at increased risk for GDM suggesting the counselling methods could be implemented in maternity care.,"[{'ForeName': 'Tarja I', 'Initials': 'TI', 'LastName': 'Kinnunen', 'Affiliation': 'School of Health Sciences, University of Tampere, Tampere, Finland The UKK Institute for Health Promotion Research, Tampere, Finland The National Institute for Health and Welfare, The Unit of Nutrition, Helsinki, Finland Science Center of Pirkanmaa Hospital District, Tampere University Hospital, Tampere, Finland The National Institute for Health and Welfare, The Unit of Sexual and Reproductive Health, Helsinki, Finland.'}, {'ForeName': 'Jatta', 'Initials': 'J', 'LastName': 'Puhkala', 'Affiliation': ''}, {'ForeName': 'Jani', 'Initials': 'J', 'LastName': 'Raitanen', 'Affiliation': ''}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Ahonen', 'Affiliation': ''}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Aittasalo', 'Affiliation': ''}, {'ForeName': 'Suvi M', 'Initials': 'SM', 'LastName': 'Virtanen', 'Affiliation': ''}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Luoto', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2012.00426.x']
2434,22661830,"Adjunctive cognitive remediation for schizophrenia using yoga: an open, non-randomized trial.","BACKGROUND: Yoga therapy (YT) improves cognitive function in healthy individuals, but its impact on cognitive function among persons with schizophrenia (SZ) has not been investigated.  AIMS: Evaluate adjunctive YT for cognitive domains impaired in SZ.  METHODS: Patients with SZ received YT or treatment as usual (TAU; n = 65, n = 23, respectively). Accuracy and speed for seven cognitive domains were assessed using a computerized neurocognitive battery (CNB), thus minimizing observer bias. Separately, YT was evaluated among patients with Bipolar I disorder (n = 40), Major Depressive Disorder (n = 37), and cardiology outpatients (n = 68). All patients also received routine pharmacotherapy. Patients were not randomized to YT or TAU.  RESULTS: Compared with the SZ/TAU group, the SZ/YT group showed significantly greater improvement with regard to measures of attention following corrections for multiple comparisons; the changes were more prominent among the men. In the other diagnostic groups, differing patterns of improvements were noted with small to medium effect sizes.  CONCLUSIONS: Our initial analyses suggest nominally significant improvement in cognitive function in schizophrenia with adjunctive therapies such as YT. The magnitude of the change varies by cognitive domain and may also vary by diagnostic group.",2012,"Compared with the SZ/TAU group, the SZ/YT group showed significantly greater improvement with regard to measures of attention following corrections for multiple comparisons; the changes were more prominent among the men.","['persons with schizophrenia (SZ', 'healthy individuals', 'patients with Bipolar I disorder (n = 40), Major Depressive Disorder (n = 37), and cardiology outpatients (n = 68']","['Yoga therapy (YT', 'routine pharmacotherapy', 'SZ/TAU']","['cognitive function', 'Accuracy and speed for seven cognitive domains']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder (disorder)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",68.0,0.0526059,"Compared with the SZ/TAU group, the SZ/YT group showed significantly greater improvement with regard to measures of attention following corrections for multiple comparisons; the changes were more prominent among the men.","[{'ForeName': 'Triptish', 'Initials': 'T', 'LastName': 'Bhatia', 'Affiliation': 'Training Program for Psychiatric Genetics in India, Post-graduate Institute for Medical Education and Research, Dr Ram Manohar Lohia Hospital, Delhi, India.'}, {'ForeName': 'Akhilesh', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': ''}, {'ForeName': 'Gyandeepak', 'Initials': 'G', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Richard', 'Affiliation': ''}, {'ForeName': 'Raquel E', 'Initials': 'RE', 'LastName': 'Gur', 'Affiliation': ''}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': ''}, {'ForeName': 'Vishwajit L', 'Initials': 'VL', 'LastName': 'Nimgaonkar', 'Affiliation': ''}, {'ForeName': 'Sati', 'Initials': 'S', 'LastName': 'Mazumdar', 'Affiliation': ''}, {'ForeName': 'Smita N', 'Initials': 'SN', 'LastName': 'Deshpande', 'Affiliation': ''}]",Acta neuropsychiatrica,[]
2435,31345639,"Long-term immunogenicity of measles, mumps and rubella-containing vaccines in healthy young children: A 10-year follow-up.","Measles and mumps outbreaks still occur in countries that have successfully implemented universal routine immunization programs. Measles outbreaks are mostly associated to absent or incomplete vaccination, whereas for mumps outbreaks the combined effects of waning of immunity and circulating new strains are incriminated. It is therefore increasingly useful to characterize the long-lasting immunity induced by measles-, mumps, and rubella (MMR)-containing vaccines. In this 10-year study, 1887 healthy children aged 12-22 months, randomized to receive 1 or 2 doses of MMR-containing vaccines (Priorix or Priorix-Tetra; GSK), were included in an antibody persistence analysis. A total of 364 children in the 1-dose group received a second dose out of study according to their local vaccination schedule between Years 4 and 10 post-dose 1, and were included in a separate post-hoc analysis to evaluate the effect of the second dose when given later. Anti-measles, -mumps and -rubella antibody titers were measured by commercial ELISA kits (Enzygnost, Siemens) after each vaccine dose and at Years 1, 2, 4, 6, 8 and 10 post-vaccination. Antibodies against measles and rubella declined moderately after vaccination but remained well above the seropositivity threshold after 10 years. The anti-measles antibody titers elicited by Priorix-Tetra remained about 2-fold higher throughout the study as compared with Priorix. A second dose of MMR vaccine later in life had a minor and transient effect on anti-measles and anti-rubella waning titers. In contrast, anti-mumps antibody levels remained relatively stable over the 10-year follow-up and a second dose of MMR vaccine, given anytime over the 10-year period, had a boosting effect on anti-mumps antibody titers and seropositivity rates. In conclusion, 1 or 2 doses of MMR-containing vaccines given to children in their second year of life induced antibody responses against measles, mumps and rubella viruses that persisted at least up to 10 years post-vaccination. Clinical trial registration number: NCT00226499.",2019,A second dose of MMR vaccine later in life had a minor and transient effect on anti-measles and anti-rubella waning titers.,"['364 children in the 1-dose group', '1887 healthy children aged 12-22\u202fmonths', 'healthy young children']","['MMR vaccine', 'MMR-containing vaccines', 'MMR-containing vaccines (Priorix or Priorix-Tetra; GSK', 'measles, mumps and rubella-containing vaccines']","['Anti-measles, -mumps and -rubella antibody titers', 'Antibodies against measles and rubella']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0065828', 'cui_str': 'MMR Vaccine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0732248', 'cui_str': 'Priorix'}, {'cui': 'C1010292', 'cui_str': 'Tetras'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0026780', 'cui_str': 'Parotitis, Epidemic'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}]","[{'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0026780', 'cui_str': 'Parotitis, Epidemic'}, {'cui': 'C0474654', 'cui_str': 'Rubella antibody titer measurement'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}]",364.0,0.0941916,A second dose of MMR vaccine later in life had a minor and transient effect on anti-measles and anti-rubella waning titers.,"[{'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Carryn', 'Affiliation': 'R&D Center Belgium, GSK, Wavre, Belgium. Electronic address: stephane.x.carryn@gsk.com.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Feyssaguet', 'Affiliation': 'Clinical Laboratory Sciences, GSK, Rixensart, Belgium. Electronic address: muriel.m.feyssaguet@gsk.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Povey', 'Affiliation': 'Biostatistics, GSK, Wavre, Belgium. Electronic address: michael.x.povey@gsk.com.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Di Paolo', 'Affiliation': 'Clinical Laboratory Sciences, GSK, Rixensart, Belgium. Electronic address: emmanuel.di-paolo@gsk.com.'}]",Vaccine,['10.1016/j.vaccine.2019.07.049']
2436,32423006,A Serious Game Approach to Improve Food Behavior in Families-A Pilot Study.,"The objective of this pilot study was to investigate the effect of a specially developed serious game to improve food behavior in families with children aged 5-13 years using mixed methods. Fourteen families were randomized into a game-group and a non-game-group and divided into age groups (game-children (GC), game-parents (GP), non-game-children (nGC), and non-game-parents (nGP)). The families completed a baseline test, a three-week intervention period with or without a game element, and a follow-up test. Qualitative results showed a positive change in food behavior in all families. Quantitative results mainly showed an effect in food neophobia as a decrease was seen in all groups; however, it was only significant ( p  < 0.05) in three groups (GP, nGC, nGP). No changes were seen in willingness to taste, and only limited changes in liking and number of words used to describe the stimuli. In conclusion, qualitative results showed positive change in the children's food behavior in most families, indicating a positive effect of performing tastings and tasks together as a family-regardless of the presence of a game element. However, this was not as clear in the quantitative data, indicating that current quantitative tools are less suited to measure complex concepts like willingness to taste.",2020,"No changes were seen in willingness to taste, and only limited changes in liking and number of words used to describe the stimuli.","['Fourteen families', 'families with children aged 5-13 years using mixed methods']","['game-group and a non-game-group and divided into age groups (game-children (GC), game-parents (GP), non-game-children (nGC), and non-game-parents (nGP']","['food behavior', 'food neophobia']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3840121', 'cui_str': 'Avoidant restrictive food intake disorder'}]",14.0,0.0359656,"No changes were seen in willingness to taste, and only limited changes in liking and number of words used to describe the stimuli.","[{'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Skouw', 'Affiliation': 'Food Design and Consumer Behavior Section, Department of Food Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Suldrup', 'Affiliation': 'Food Design and Consumer Behavior Section, Department of Food Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Olsen', 'Affiliation': 'Food Design and Consumer Behavior Section, Department of Food Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}]",Nutrients,['10.3390/nu12051415']
2437,32422956,Traditional Brazilian Diet and Olive Oil Reduce Cardiometabolic Risk Factors in Severely Obese Individuals: A Randomized Trial.,"Cardioprotective effects associated with extra virgin olive oil (EVOO) have been studied within the Mediterranean diet. However, little is known about its consumption in the traditional Brazilian diet (DieTBra) or without any dietary prescription, particularly in severely obese individuals. This study aimed to assess the effectiveness of DieTBra and EVOO in cardiometabolic risk factor (CMRF) reduction in severely obese individuals. We conducted a parallel randomized clinical trial with 149 severely obese individuals (body mass index ≥ 35.0 kg/m 2 ) aged 18-65 years, assigned to three groups: 52 mL/day of EVOO ( n  = 50), DieTBra ( n  = 49), and DieTBra + 52 mL/day of EVOO ( n  = 50). Participants were followed up for 12 weeks. Low-density lipoprotein cholesterol (LDL-c) was the primary endpoint and several cardiometabolic parameters were secondary endpoints. Endpoints were compared at baseline and at the end of the study using analysis of variance, the Kruskal-Wallis test, and Student's  t -test. The TC/High-density lipoprotein (HDL) ratio (-0.33 ± 0.68,  p  = 0.002) and LDL/HDL ratio (-0.26 ± 0.59,  p  = 0.005) decreased in the EVOO group. Delta values for all variables showed no significant statistical difference between groups. However, we highlight the clinical significance of LDL-c reduction in the EVOO group by 5.11 ± 21.79 mg/dL and in the DieTBra group by 4.27 ± 23.84 mg/dL. We also found a mean reduction of around 10% for Castelli II (LDL/HDL) and homocysteine in the EVOO group and TG and the TG/HDL ratio in the DieTBra group. EVOO or DieTBra when administered alone lead to reduction in some cardiometabolic risk parameters in severely obese individuals.",2020,Delta values for all variables showed no significant statistical difference between groups.,"['Severely Obese Individuals', 'severely obese individuals', '149 severely obese individuals (body mass index ≥ 35.0 kg/m 2 ) aged 18-65 years']","['DieTBra and EVOO', 'extra virgin olive oil (EVOO', 'EVOO or DieTBra', 'Traditional Brazilian Diet and Olive Oil']","['cardiometabolic risk factor (CMRF) reduction', 'cardiometabolic risk parameters', 'LDL/HDL ratio', 'Delta values', 'TC/High-density lipoprotein (HDL) ratio', 'Low-density lipoprotein cholesterol (LDL-c', 'TG/HDL ratio']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1171408', 'cui_str': 'High density/low density lipoprotein ratio measurement'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",149.0,0.0600881,Delta values for all variables showed no significant statistical difference between groups.,"[{'ForeName': 'Annelisa Silva E Alves de Carvalho', 'Initials': 'ASEAC', 'LastName': 'Santos', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74.650-050, GO, Brazil.'}, {'ForeName': 'Ana Paula Dos Santos', 'Initials': 'APDS', 'LastName': 'Rodrigues', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74.650-050, GO, Brazil.'}, {'ForeName': 'Lorena Pereira de Souza', 'Initials': 'LPS', 'LastName': 'Rosa', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74.650-050, GO, Brazil.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Noll', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74.650-050, GO, Brazil.'}, {'ForeName': 'Erika Aparecida', 'Initials': 'EA', 'LastName': 'Silveira', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia 74.650-050, GO, Brazil.'}]",Nutrients,['10.3390/nu12051413']
2438,32423151,Effects of Different Ankle Supports on the Single-Leg Lateral Drop Landing Following Muscle Fatigue in Athletes with Functional Ankle Instability.,"BACKGROUND


Ankle support has been utilized for athletes with functional ankle instability (FAI), however, its effect on the landing performance during muscle fatigue is not well understood. This study aimed to examine the effects of ankle supports (ankle brace vs. Kinesio tape) on athletes with FAI following fatigued single-leg landing.
METHODS


Thirty-three young FAI athletes (CAIT scores < 24) were randomly allocated to control (Cn), ankle brace (AB) and Kinesio tape (KT) groups. All athletes performed single-leg lateral drop landings following ankle fatigue protocol. The fatigue-induced changes in kinetic parameters were measured among three groups.
RESULTS


A significant increase in peak vertical ground reaction force (vGRF) was found in the AB group (0.12% body weight (BW)) compared to that of the KT (0.02% BW) and Cn (median = 0.01% BW) groups. Significant decrease in both COP medial-lateral (ML) and anterior-posterior (AP) ranges were also found in the KT group (median = -0.15% foot width (FW) & median = -0.28% foot length (FL)) than those of the Cn group (median = 0.67% FW& median = 0.88% FL).
CONCLUSIONS


Ankle braces might hamper the ability to absorb the impact force during landing. On the other hand, Kinesio tape might be beneficial for the postural control during landing.",2020,A significant increase in peak vertical ground reaction force (vGRF) was found in the AB group (0.12% body weight (BW)) compared to that of the KT (0.02% BW) and Cn (median = 0.01% BW) groups.,"['Athletes with Functional Ankle Instability', 'athletes with FAI following fatigued single-leg landing', 'Thirty-three young FAI athletes (CAIT scores < 24', 'athletes with functional ankle instability (FAI']","['Single-Leg Lateral Drop Landing', 'ankle supports (ankle brace vs. Kinesio tape', 'control (Cn), ankle brace (AB) and Kinesio tape (KT']","['peak vertical ground reaction force (vGRF', 'COP medial-lateral (ML) and anterior-posterior (AP) ranges']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",33.0,0.0268298,A significant increase in peak vertical ground reaction force (vGRF) was found in the AB group (0.12% body weight (BW)) compared to that of the KT (0.02% BW) and Cn (median = 0.01% BW) groups.,"[{'ForeName': 'Cheng-Chieh', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Therapy, Tzu Hui Institute of Technology, Pingtung 926001, Taiwan.'}, {'ForeName': 'Shing-Jye', 'Initials': 'SJ', 'LastName': 'Chen', 'Affiliation': 'Department of Product Design, College of Design, Tainan University of Technology, Tainan 71002, Taiwan.'}, {'ForeName': 'Wan-Chin', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan 70101, Taiwan.'}, {'ForeName': 'Cheng-Feng', 'Initials': 'CF', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan 70101, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17103438']
2439,32423007,Influence of a Lubricating Gel (Orthospeed®) on Pain and Oral Health-Related Quality of Life in Orthodontic Patients during Initial Therapy with Conventional and Low-Friction Brackets: A Prospective Randomized Clinical Trial.,"The aim of this study was to investigate whether statistically significant differences exist regarding pain and the impact on oral quality of life of orthodontic treatment. A conventional brackets system was compared with low-friction brackets. A total of 90 patients (male = 35, female = 55) were chosen for this randomized clinical trial. Pain was assessed at 4, 8, and 24 hours and 2, 3, 4, 5, 6, and 7 days after the start of treatment using the McGill Pain Questionnaire. Oral health-related quality of life (OHRQoL) was assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. Oral quality of life was assessed at one month, with patients with low-friction brackets describing lower levels of pain. The patients with conventional brackets indicated a worse impact on their quality of life compared to the group with low-friction brackets. Statistically significant differences were found between the groups, with maximum pain observed between the first 24 and 48 hours, and the values of minimum pain are reached after 7 days. The pain and impact on oral quality of life was statistically worse in patients with conventional brackets compared to patients with low-friction brackets. The type of bracket system used was therefore shown to influence patients' perceptions of pain and impact on their OHRQoL.",2020,The patients with conventional brackets indicated a worse impact on their quality of life compared to the group with low-friction brackets.,"['Orthodontic Patients during Initial Therapy with Conventional and Low-Friction Brackets', '90 patients (male = 35, female = 55']","['Lubricating Gel (Orthospeed®', 'OHRQoL']","['quality of life', 'Oral health-related quality of life (OHRQoL', 'Oral quality of life', 'Pain', 'Oral Health Impact Profile-14 (OHIP-14) questionnaire', 'values of minimum pain', 'pain', 'oral quality of life of orthodontic treatment', 'oral quality of life', 'Pain and Oral Health-Related Quality of Life', 'maximum pain', 'McGill Pain Questionnaire']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162691', 'cui_str': 'Friction'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}]",90.0,0.0922206,The patients with conventional brackets indicated a worse impact on their quality of life compared to the group with low-friction brackets.,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Curto', 'Affiliation': 'DDS, Professor in Pediatric Dentistry, Faculty of Medicine, University of Salamanca, Avenida Alfonso X el Sabio s/n. 37007 Salamanca, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Albaladejo', 'Affiliation': 'DDS, Professor in Orthodontics, Faculty of Medicine, University of Salamanca, Avenida Alfonso X el Sabio s/n. 37007 Salamanca, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Montero', 'Affiliation': 'DDS, Professor in Prosthodontics, Faculty of Medicine, University of Salamanca, Avenida Alfonso X el Sabio s/n. 37007 Salamanca, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Alvarado', 'Affiliation': 'DDS, Professor in Orthodontics, Faculty of Medicine, University of Salamanca, Avenida Alfonso X el Sabio s/n. 37007 Salamanca, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9051474']
2440,22625182,"Cluster-randomized trial on complementary and responsive feeding education to caregivers found improved dietary intake, growth and development among rural Indian toddlers.","Inadequate feeding and care may contribute to high rates of stunting and underweight among children in rural families in India. This cluster-randomized trial tested the hypothesis that teaching caregivers appropriate complementary feeding and strategies for how to feed and play responsively through home-visits would increase children's dietary intake, growth and development compared with home-visit-complementary feeding education alone or routine care. Sixty villages in Andhra Pradesh were randomized into three groups of 20 villages with 200 mother-infant dyads in each group. The control group (CG) received routine Integrated Child Development Services (ICDS); the complementary feeding group (CFG) received the ICDS plus the World Health Organization recommendations on breastfeeding and complementary foods; and the responsive complementary feeding and play group (RCF&PG) received the same intervention as the CFG plus skills for responsive feeding and psychosocial stimulation. Both intervention groups received bi-weekly visits by trained village women. The groups did not differ at 3 months on socioeconomic status, maternal and child nutritional indices, and maternal depression. After controlling for potential confounding factors using the mixed models approach, the 12-month intervention to the CFG and RCF&PG significantly (P < 0.05) increased median intakes of energy, protein, Vitamin A, calcium (CFG), iron and zinc, reduced stunting [0.19, confidence interval (CI): 0.0-0.4] in the CFG (but not RCF&PG) and increased (P < 0.01) Bayley Mental Development scores (mean = 3.1, CI: 0.8-5.3) in the RCF&PG (but not CFG) compared with CG. Community-based educational interventions can improve dietary intake, length (CFG) and mental development (RCF&PG) for children under 2 years in food-secure rural Indian families.",2013,"Community-based educational interventions can improve dietary intake, length (CFG) and mental development (RCF&PG) for children under 2 years in food-secure rural Indian families.","['rural Indian toddlers', 'Sixty villages in Andhra Pradesh were randomized into three groups of 20 villages with 200 mother-infant dyads in each group', 'children under 2 years in food-secure rural Indian families']","['complementary and responsive feeding education', 'control group (CG) received routine Integrated Child Development Services (ICDS); the complementary feeding group (CFG', 'RCF&PG', 'ICDS plus the World Health Organization recommendations on breastfeeding and complementary foods; and the responsive complementary feeding and play group (RCF&PG) received the same intervention as the CFG plus skills for responsive feeding and psychosocial stimulation', 'Community-based educational interventions']","['dietary intake, growth and development', 'dietary intake, length (CFG) and mental development (RCF&PG', 'Bayley Mental Development scores', 'socioeconomic status, maternal and child nutritional indices, and maternal depression', 'median intakes of energy, protein, Vitamin A, calcium (CFG), iron and zinc, reduced stunting']","[{'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C1457898', 'cui_str': 'growth & development'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028710', 'cui_str': 'Nutrition Indexes'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}]",,0.0283325,"Community-based educational interventions can improve dietary intake, length (CFG) and mental development (RCF&PG) for children under 2 years in food-secure rural Indian families.","[{'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Vazir', 'Affiliation': 'Behavioral Sciences Unit of Field Studies, National Institute of Nutrition (ICMR), Hyderabad, India. s_vazir@hotmail.com'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Engle', 'Affiliation': ''}, {'ForeName': 'Nagalla', 'Initials': 'N', 'LastName': 'Balakrishna', 'Affiliation': ''}, {'ForeName': 'Paula L', 'Initials': 'PL', 'LastName': 'Griffiths', 'Affiliation': ''}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Creed-Kanashiro', 'Affiliation': ''}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Fernandez Rao', 'Affiliation': ''}, {'ForeName': 'Monal R', 'Initials': 'MR', 'LastName': 'Shroff', 'Affiliation': ''}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Bentley', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2012.00413.x']
2441,22590991,Patterns of compliance with prenatal iron supplementation among Peruvian women.,"Prenatal iron supplementation is recommended to control anaemia during pregnancy. Low compliance and side effects have been claimed as the main obstacles for adequate impact of the supplementation. As part of a double-blind supplementation study carried out in a hospital located in a shantytown in Lima, Peru, we monitored compliance throughout pregnancy and evaluated factors associated with variation in compliance over time. Overall, 985 pregnant women were enrolled in a supplementation study that was administered through their prenatal care from 10 to 24 weeks of gestation until 4 weeks postpartum. They received 60 mg iron and 250 µg folate with or without 15 mg zinc. Women had monthly care visits and were also visited weekly to query regarding compliance, overall health status, and potential positive and negative effects of supplement consumption. Median compliance was 79% (inter-quartile range: 65-89%) over pregnancy, and the median number of tablets consumed was 106 (81-133). Primpara had lower average compliance; positive health reports were associated with greater compliance, and negative reports were associated with lower compliance. There was no difference by type of supplement. Women with low initial compliance did achieve high compliance by the end of pregnancy, and women who reported forgetting to take the supplements did have lower compliance. Compliance was positively associated with haemoglobin concentration at the end of pregnancy. In conclusion, women comply highly with prenatal supplementation within a prenatal care model in which supplies are maintained and reinforcing messages are provided.",2014,"Primpara had lower average compliance; positive health reports were associated with greater compliance, and negative reports were associated with lower compliance.","['Peruvian women', '985 pregnant women']","['Prenatal iron supplementation', '60 mg iron and 250 µg folate with or without 15 mg zinc', 'prenatal iron supplementation']","['haemoglobin concentration', 'Median compliance']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]","[{'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",985.0,0.0697346,"Primpara had lower average compliance; positive health reports were associated with greater compliance, and negative reports were associated with lower compliance.","[{'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Zavaleta', 'Affiliation': 'Instituto de Investigación Nutricional (IIN), Avenida La Universidad 685, La Molina, Lima, Peru Center for Human Nutrition, Department of International Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Caulfield', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Figueroa', 'Affiliation': ''}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2012.00407.x']
2442,32423038,A Longitudinal Study of a Multicomponent Exercise Intervention with Remote Guidance among Breast Cancer Patients.,"Purpose : Breast cancer patients in treatment suffer from long-term side effects that seriously influence their physical and mental health. The aim of this study was to examine effectiveness of a 12-week multicomponent exercise (ME) with remote guidance intervention on health-related outcomes after one year among breast cancer patients.  Methods : In phases I-III, 60 patients (51.2 ± 7.9 years) with breast cancer (BC) who completed chemotherapy/postoperative radiotherapy within the previous four months to two years were randomly assigned to 1) multicomponent exercise with remote guidance (ME) and 2) usual care (UC). Eligible participants were approached to assess cancer-related quality of life (QOL), muscle strength, cardiorespiratory endurance, and physical activity (PA) barriers after one year.  Results : The results demonstrated that, after one year, the ME group reported higher vitality-related QOL (5.776, 95% confidence interval [CI] 0.987, 10.565, effect size [ES] = 0.360), mental health-related QOL (9.938, 95% CI 4.146, 15.729, ES = 0.512), leg strength and endurance (2.880, CI 1.337, 4.423, ES = 0.557), and strength and endurance of upper extremities (2.745, 95% CI 1.076, 4.415, ES = 0.491) and lower physical activity (PA) hindrance (5.120, 95% CI 1.976, 8.264, ES = 0.486) than the UC group.  Conclusion : The ME group observed significant differences from the UC group in QOL, muscle strength, cardiopulmonary endurance, and PA participation. These findings suggested that the multicomponent exercise intervention with remote guidance produced long-term health benefits for breast cancer patients.",2020,"The results demonstrated that, after one year, the ME group reported higher vitality-related QOL (5.776, 95% confidence interval [CI] 0.987, 10.565, effect size [ES] = 0.360), mental health-related QOL (9.938, 95% CI 4.146, 15.729, ES = 0.512), leg strength and endurance (2.880, CI 1.337, 4.423, ES = 0.557), and strength and endurance of upper extremities (2.745, 95% CI 1.076, 4.415, ES = 0.491) and lower physical activity (PA) hindrance (5.120, 95% CI 1.976, 8.264, ES = 0.486) than the UC group.  ","['breast cancer patients', 'Breast Cancer Patients', '60 patients (51.2 ± 7.9 years) with breast cancer (BC) who completed']","['multicomponent exercise (ME) with remote guidance intervention', 'multicomponent exercise intervention', 'Multicomponent Exercise Intervention', 'chemotherapy', 'multicomponent exercise with remote guidance (ME) and 2) usual care (UC', 'postoperative radiotherapy']","['higher vitality-related QOL', 'leg strength and endurance', 'lower physical activity (PA) hindrance', 'mental health-related QOL', 'QOL, muscle strength, cardiopulmonary endurance, and PA participation', 'strength and endurance of upper extremities', 'cancer-related quality of life (QOL), muscle strength, cardiorespiratory endurance, and physical activity (PA) barriers']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.0333744,"The results demonstrated that, after one year, the ME group reported higher vitality-related QOL (5.776, 95% confidence interval [CI] 0.987, 10.565, effect size [ES] = 0.360), mental health-related QOL (9.938, 95% CI 4.146, 15.729, ES = 0.512), leg strength and endurance (2.880, CI 1.337, 4.423, ES = 0.557), and strength and endurance of upper extremities (2.745, 95% CI 1.076, 4.415, ES = 0.491) and lower physical activity (PA) hindrance (5.120, 95% CI 1.976, 8.264, ES = 0.486) than the UC group.  ","[{'ForeName': 'Xiaosheng', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Department of Sport and Health, School of Physical Education, Shandong University, Jinan 250061, China.'}, {'ForeName': 'Xiangren', 'Initials': 'X', 'LastName': 'Yi', 'Affiliation': 'Department of Sport and Health, School of Physical Education, Shandong University, Jinan 250061, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'College of Physical Education, Shandong Normal University, Jinan 250014, China.'}, {'ForeName': 'Zan', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'School of Kinesiology, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'McDonough', 'Affiliation': 'School of Kinesiology, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Nuo', 'Initials': 'N', 'LastName': 'Yi', 'Affiliation': 'Department of Kinesiology, College of Health Science University of Wisconsin, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Wenzhen', 'Initials': 'W', 'LastName': 'Qiao', 'Affiliation': 'Department of Science and Technology, Shandong Institute of Commerce and Technology, Jinan 250103, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17103425']
2443,22591950,Neurophysiological effects of modafinil on cue-exposure in cocaine dependence: a randomized placebo-controlled cross-over study using pharmacological fMRI.,"OBJECTIVE


Enhanced reactivity to substance related cues is a central characteristic of addiction and has been associated with increased activity in motivation, attention, and memory related brain circuits and with a higher probability of relapse. Modafinil was promising in the first clinical trials in cocaine dependence, and was able to reduce craving in addictive disorders. However, its mechanism of action remains to be elucidated. In this functional magnetic resonance imaging (fMRI) study therefore, cue reactivity in cocaine dependent patients was compared to cue reactivity in healthy controls (HCs) under modafinil and placebo conditions.
METHODS


An fMRI cue reactivity study, with a double-blind, placebo-controlled cross-over challenge with a single dose of modafinil (200mg) was employed in 13 treatment seeking cocaine dependent patients and 16 HCs.
RESULTS


In the placebo condition, watching cocaine-related pictures (versus neutral pictures) resulted in higher brain activation in the medial frontal cortex, anterior cingulate cortex, angular gyrus, left orbitofrontal cortex, and ventral tegmental area (VTA) in the cocaine dependent group compared to HCs. However, in the modafinil condition, no differences in brain activation patterns were found between cocaine dependent patients and HCs. Group interactions revealed decreased activity in the VTA and increased activity in the right ACC and putamen in the modafinil condition relative to the placebo condition in cocaine dependent patients, whereas such changes were not present in healthy controls. Decreases in self-reported craving when watching cocaine-related cues after modafinil administration compared to the placebo condition were associated with modafinil-induced increases in ACC and putamen activation.
CONCLUSIONS


Enhanced cue reactivity in the cocaine dependent group compared to healthy controls was found in brain circuitries related to reward, motivation, and autobiographical memory processes. In cocaine dependent patients, these enhanced brain responses were attenuated by modafinil, mainly due to decreases in cue- reactivity in reward-related brain areas (VTA) and increases in cue reactivity in cognitive control areas (ACC). These modafinil-induced changes in brain activation in response to cocaine-related visual stimuli were associated with diminished self-reported craving. These findings imply that in cocaine dependent patients, modafinil, although mainly known as a cognitive enhancer, acts on both the motivational and the cognitive brain circuitry.",2013,"Decreases in self-reported craving when watching cocaine-related cues after modafinil administration compared to the placebo condition were associated with modafinil-induced increases in ACC and putamen activation.
","['13 treatment seeking cocaine dependent patients and 16 HCs', 'cocaine dependence', 'healthy controls (HCs) under']","['placebo', 'cocaine', 'watching cocaine-related pictures (versus neutral pictures', 'modafinil', 'modafinil and placebo', 'Modafinil']","['cue reactivity', 'higher brain activation in the medial frontal cortex, anterior cingulate cortex, angular gyrus, left orbitofrontal cortex, and ventral tegmental area (VTA', 'cue reactivity in cognitive control areas (ACC', 'activity', 'brain activation patterns', 'brain activation', 'ACC and putamen activation', 'reward, motivation, and autobiographical memory processes', 'enhanced brain responses', 'cue- reactivity in reward-related brain areas (VTA']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0600427', 'cui_str': 'Cocaine Dependence'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0066677', 'cui_str': 'modafinil'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0016733', 'cui_str': 'Frontal Cortex'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0152305', 'cui_str': 'Prelunate Gyrus'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0175405', 'cui_str': 'Area Tegmentalis Ventralis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0034169', 'cui_str': 'Nucleus Putamen'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.0503701,"Decreases in self-reported craving when watching cocaine-related cues after modafinil administration compared to the placebo condition were associated with modafinil-induced increases in ACC and putamen activation.
","[{'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Goudriaan', 'Affiliation': 'Amsterdam Institute for Addiction Research, Department of Psychiatry, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Arkin Mental Health, Amsterdam, The Netherlands. Electronic address: a.e.goudriaan@amc.uva.nl.'}, {'ForeName': 'Dick J', 'Initials': 'DJ', 'LastName': 'Veltman', 'Affiliation': 'Amsterdam Institute for Addiction Research, Department of Psychiatry, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Department of Psychiatry, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'van den Brink', 'Affiliation': 'Amsterdam Institute for Addiction Research, Department of Psychiatry, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Dom', 'Affiliation': 'Collaborative Antwerp Psychiatric Research Institute, Antwerp University, Antwerp, Belgium.'}, {'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Schmaal', 'Affiliation': 'Amsterdam Institute for Addiction Research, Department of Psychiatry, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}]",Addictive behaviors,['10.1016/j.addbeh.2012.04.006']
2444,32423143,Effect of Impulsivity Traits on Food Choice within a Nudging Intervention.,"Food choices are often driven by impulsive tendencies rather than rational consideration. Some individuals may find it more difficult resisting impulses related to unhealthy food choices, and low self-control and high impulsivity have been suggested to be linked to these behaviors. Recent shifts have been made towards developing strategies that target automatic processes of decision-making and focus on adjusting the environment, referred to as nudging interventions. Therefore, the purpose of this study was to investigate the effect of impulsivity traits on food choices within a nudging intervention (increased perceived variety). A total of 83 adults participated in an experimental study consisting of a self-service intelligent buffet. Impulsivity traits were measured using the UPPS-P impulsivity scale. General linear models were fitted to evaluate the effect of the five impulsivity traits on the difference of salad consumption (g) between the control and intervention situations. Results showed that impulsivity does not affect food choices in this nudging situation, suggesting that nudging works independently of the participant's impulsivity score. Results also showed a significantly higher consumption of salad in the nudging versus the control setting (17.6 g, p < 0.05), suggesting that nudging interventions can be effective in significantly increasing total vegetable consumption across the whole impulsivity scale.",2020,"Results also showed a significantly higher consumption of salad in the nudging versus the control setting (17.6 g, p < 0.05), suggesting that nudging interventions can be effective in significantly increasing total vegetable consumption across the whole impulsivity scale.",['83 adults participated in an experimental study consisting of a self-service intelligent buffet'],[],"['Impulsivity traits', 'higher consumption of salad', 'UPPS-P impulsivity scale', 'total vegetable consumption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],"[{'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0453740', 'cui_str': 'Salad'}, {'cui': 'C0200005', 'cui_str': 'Urethral pressure profile study'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]",83.0,0.0272269,"Results also showed a significantly higher consumption of salad in the nudging versus the control setting (17.6 g, p < 0.05), suggesting that nudging interventions can be effective in significantly increasing total vegetable consumption across the whole impulsivity scale.","[{'ForeName': 'Irene C F', 'Initials': 'ICF', 'LastName': 'Marques', 'Affiliation': 'Future Consumer Lab, Department of Food Science, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Ting', 'Affiliation': 'Future Consumer Lab, Department of Food Science, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Cedillo-Martínez', 'Affiliation': 'Future Consumer Lab, Department of Food Science, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Federico J A', 'Initials': 'FJA', 'LastName': 'Pérez-Cueto', 'Affiliation': 'Future Consumer Lab, Department of Food Science, Faculty of Science, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Denmark.'}]",Nutrients,['10.3390/nu12051402']
2445,32423126,Effects of Combined Resistance and Power Training on Cognitive Function in Older Women: A Randomized Controlled Trial.,"The present study compared the effects of traditional resistance training (TRT) and combined power training (PT) and TRT (PTRT) on cognitive parameters and serum brain-derived neurotrophic factor (BDNF) levels in non-demented, well-functioning, community-dwelling older women. Forty-five older women were randomized into one of three experimental groups: TRT, PTRT, and control group (CG). Cognitive tests explored global cognitive function, short-term memory, and dual-task performance. Serum BDNF levels were assessed at baseline and after the intervention. Exercise sessions were performed twice a week over 22 weeks. In TRT, exercise sessions were based on three sets of 8-10 repetitions at ""difficult"" intensity. In PTRT, the first session was based on PT (three sets of 8-10 repetitions at ""moderate"" intensity), while the second session was similar to the TRT. Our analyses indicated that overall cognitive function, short-term memory, and dual-task performance were similarly improved after TRT and PTRT. Serum BDNF concentrations were not altered by any training protocol. In conclusion, the two RT programs tested in the present trial improved global cognitive function, short-term memory and dual task performance in non-demented, well-functioning, community-dwelling older women. In addition, our findings suggest that mechanisms other than BDNF may be associated with such improvements.",2020,"Our analyses indicated that overall cognitive function, short-term memory, and dual-task performance were similarly improved after TRT and PTRT.","['Forty-five older women', 'Older Women', 'non-demented, well-functioning, community-dwelling older women']","['traditional resistance training (TRT) and combined power training (PT) and TRT (PTRT', 'TRT, PTRT, and control group (CG', 'Combined Resistance and Power Training']","['cognitive parameters and serum brain-derived neurotrophic factor (BDNF) levels', 'global cognitive function, short-term memory, and dual-task performance', 'Serum BDNF concentrations', 'global cognitive function, short-term memory and dual task performance', 'Serum BDNF levels', 'Cognitive Function', 'overall cognitive function, short-term memory, and dual-task performance']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",45.0,0.0217528,"Our analyses indicated that overall cognitive function, short-term memory, and dual-task performance were similarly improved after TRT and PTRT.","[{'ForeName': 'Hélio José', 'Initials': 'HJ', 'LastName': 'Coelho-Júnior', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}, {'ForeName': 'Ivan de Oliveira', 'Initials': 'IO', 'LastName': 'Gonçalves', 'Affiliation': 'Center of Health Sciences, University of Mogi das Cruzes, Mogi das Cruzes 08780-911, Brazil.'}, {'ForeName': 'Ricardo Aurélio Carvalho', 'Initials': 'RAC', 'LastName': 'Sampaio', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}, {'ForeName': 'Priscila Yukari Sewo', 'Initials': 'PYS', 'LastName': 'Sampaio', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Lusa Cadore', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, RS 90040-060, Brazil.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Calvani', 'Affiliation': 'Institute of Internal Medicine and Geriatrics, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Picca', 'Affiliation': 'Institute of Internal Medicine and Geriatrics, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), Navarra Institute for Health Research (IdiSNA), 31008 Pamplona, Spain.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Marzetti', 'Affiliation': 'Fondazione Policlinico Universitario ""Agostino Gemelli"" IRCCS, 00168 Rome, Italy.'}, {'ForeName': 'Marco Carlos', 'Initials': 'MC', 'LastName': 'Uchida', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17103435']
2446,32423396,Effects of journal therapy counseling with anxious pregnant women on their infants' sleep quality: a randomized controlled clinical trial.,"BACKGROUND


Sleep is especially important for infants, since it stimulates the development of neural connections in their brains. Psychological stress such as anxiety could affect sleep quality. This study investigated the effects of journal therapy counseling sessions on the infants' sleep quality based on mothers' perception (primary outcome), maternal anxiety, infants' anthropometric and developmental parameters, and the frequency of exclusive breastfeeding (secondary outcomes).
METHODS


A total of 70 healthy women with gestational age of 28-31 weeks participated in this randomized controlled trial. The participants were randomly allocated into intervention and control groups using randomized block design. Three in-person journal therapy sessions and three telephone counseling sessions (2 between in-person sessions and 1 one month postpartum) were provided to those in the intervention group, while the control group only received routine care. The Infant Sleep Questionnaire (ISQ), Exclusive Breastfeeding Checklist, and Infant Anthropometric Parameters Checklist were completed at two and four months postpartum. The Beck Anxiety Inventory (BAI) was completed during pregnancy, at the end of the intervention, and at two and four months postpartum, and the Ages and Stages Questionnaire (ASQ) was completed at 4 months postpartum. Data were analyzed using chi-square, independent t-test, ANCOVA and repeated measure ANOVA.
RESULTS


There was no significant difference between the two groups in demographic characteristics and baseline anxiety scores. The mean sleep quality score in infants two months of age (MD: -4.2; 95%CI: - 1.1 to - 7.2; P = 0.007) and four months of age (MD: -5.5; 95%CI: - 8.4 to - 2.7; P < 0.001) was significantly lower in the intervention group than that of those in the control group. Based on the repeated measure ANOVA results, the mean postpartum anxiety score of mothers in the intervention group was significantly lower than that of those in the control group (AMD: -7.7; 95%CI: - 5.5 to - 10.1; P < 0.001). There was no significant difference between the two groups regarding other outcomes including the frequency of exclusive breastfeeding, and anthropometric and developmental parameters (P > 0.05).
CONCLUSION


Journal therapy can decrease mothers' anxiety and improve the infants' sleep quality based on their perception. However, further studies are required before drawing any definitive conclusion.
TRIAL REGISTRATION NUMBER


Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: August 11, 2018. URL: https://en.irct.ir/trial/33211.",2020,"There was no significant difference between the two groups regarding other outcomes including the frequency of exclusive breastfeeding, and anthropometric and developmental parameters (P > 0.05).
","['infants two months of age (MD', '70 healthy women with gestational age of 28-31\u2009weeks', ""anxious pregnant women on their infants' sleep quality""]","['journal therapy counseling sessions', 'telephone counseling sessions', 'control group only received routine care', 'journal therapy counseling']","['Beck Anxiety Inventory (BAI', 'mean postpartum anxiety score', 'demographic characteristics and baseline anxiety scores', ""mothers' anxiety"", 'mean sleep quality score', ""infants' sleep quality based on mothers' perception (primary outcome), maternal anxiety, infants' anthropometric and developmental parameters, and the frequency of exclusive breastfeeding (secondary outcomes"", 'frequency of exclusive breastfeeding, and anthropometric and developmental parameters', 'Infant Sleep Questionnaire (ISQ), Exclusive Breastfeeding Checklist, and Infant Anthropometric Parameters Checklist', 'sleep quality']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]","[{'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4761105', 'cui_str': 'Postpartum anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",70.0,0.0872959,"There was no significant difference between the two groups regarding other outcomes including the frequency of exclusive breastfeeding, and anthropometric and developmental parameters (P > 0.05).
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Montazeri', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social Determinants of Health Research Centre, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. mirghafourvand@gmail.com.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Esmaeilpour', 'Affiliation': 'Faculty of Education and Psychology, University of Tabriz, Tabriz, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Mohammad-Alizadeh-Charandabi', 'Affiliation': 'Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Paria', 'Initials': 'P', 'LastName': 'Amiri', 'Affiliation': 'School of Nursing and Midwifery, Tabriz University of Medical Science, Tabriz, Iran.'}]",BMC pediatrics,['10.1186/s12887-020-02132-7']
2447,32423239,Post hoc  Responder and Remission Analyses from Two Studies of SHP465 Mixed Amphetamine Salts Extended-Release Among Adults with Attention-Deficit/Hyperactivity Disorder.,"Objectives:  In two studies of adult attention-deficit/hyperactivity disorder (ADHD), SHP465 mixed amphetamine salts (MAS) extended-release significantly reduced ADHD-Rating Scale, 4th Edition total score (ADHD-RS-IV-TS) versus placebo (PBO). This report describes  post hoc  analyses of SHP465 MAS treatment response and remission rates from those studies.  Methods:  Adults with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision-defined ADHD were randomized to SHP465 MAS (12.5-75 mg) or PBO in a 7-week dose-optimization study and to SHP465 MAS (25, 50, or 75 mg) or PBO in a 6-week fixed-dose study. Response was examined using three definitions (definition 1: ≥30% ADHD-RS-IV-TS reduction + Clinical Global Impressions-Improvement [CGI-I] rating of 1 or 2; definition 2: ≥50% ADHD-RS-IV-TS reduction + CGI-I rating of 1 or 2; definition 3: ADHD-RS-IV-TS ≤18). Remission was defined as ADHD-RS-IV-TS ≤12. The Kaplan-Meier analyses assessed time to response or remission.  Results:  The intent-to-treat populations included 136 SHP465 MAS and 132 PBO participants in the dose-optimization study and 302 SHP465 MAS and 103 PBO participants in the fixed-dose study. Percentages of participants meeting response criteria (SHP465 MAS vs. PBO) at the final treatment week in the dose-optimization and fixed-dose studies, respectively, were 66.0% versus 31.6% and 72.7% versus 28.3% (definition 1); 47.9% versus 27.6% and 60.6% versus 16.7% (definition 2); and 54.3% versus 30.3% and 52.6% versus 18.3% (definition 3). The remission criterion (SHP465 MAS vs. PBO) at the final treatment week was met by 37.2% versus 19.7% of participants in the dose-optimization study and 39.7% versus 10.0% of participants in the fixed-dose study. Times to response and remission favored SHP465 MAS over PBO in both studies (all nominal log-rank  p  < 0.0001).  Conclusion:  These  post hoc  analyses indicate that SHP465 MAS was associated with greater response and remission rates than PBO in adults with ADHD, with times to response and remission also nominally favoring SHP465 MAS.",2020,Times to response and remission favored SHP465 MAS over PBO in both studies (all nominal log-rank  p  < 0.0001).  ,"['Adults with Attention-Deficit/Hyperactivity Disorder', '132 PBO participants in the dose-optimization study and 302 SHP465 MAS and 103 PBO participants in the fixed-dose study', 'Adults with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision-defined ADHD']","['SHP465 MAS', 'PBO', 'SHP465 Mixed Amphetamine Salts', 'SHP465 mixed amphetamine salts (MAS']","['time to response or remission', 'remission rates', 'remission criterion (SHP465 MAS vs. PBO', 'Remission', 'ADHD-Rating Scale, 4th Edition total score', 'response and remission rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.030036,Times to response and remission favored SHP465 MAS over PBO in both studies (all nominal log-rank  p  < 0.0001).  ,"[{'ForeName': 'Lenard A', 'Initials': 'LA', 'LastName': 'Adler', 'Affiliation': 'Department of Psychiatry and NYU Langone Medical Center, New York, New York, USA.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Robertson', 'Affiliation': 'Global Clinical Development, Shire, a member of the Takeda group of companies, Lexington, Massachusetts, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Biostatistics, Shire, a member of the Takeda group of companies, Lexington, Massachusetts, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Sarkis', 'Affiliation': 'Sarkis Family Psychiatry, Gainesville, Florida, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0012']
2448,32423247,Effect of Nasal Steroids on Nasal Obstruction in Septal Deviation: A Double-Blind Randomized Controlled Trial.,"Objective:  This study sought to prospectively determine the effect of intranasal steroids versus placebo on nasal obstruction in septal deviation.  Methods:  This was a single-center randomized placebo-controlled double-blind trial with crossover in which all study participants received 6 weeks of therapy with Nasacort (Chattem, Inc.) and with Ayr saline spray (B.F. Ascher). Participants were randomized to one of two groups with a 2-week washout period between drugs. Nasal Obstruction Symptom Evaluation (NOSE) scores were collected at baseline and after each study drug. A subset of patients subsequently underwent surgical intervention after both drugs and additional NOSE scores were collected postoperatively.  Results:  Forty-two patients completed both study drugs with NOSE scores collected. Thirty-two patients underwent surgery and postoperative NOSE scores were collected. There was no significant difference in baseline demographics between the groups. There was no significant difference in mean NOSE scores in either group from baseline to the completion of the first and second study drugs. There was no difference in the change in mean NOSE score from baseline to postsaline (-3.9) versus baseline to poststeroid (-5.8,  p  = 0.60). Surgery resulted in a significant change in NOSE score at all postoperative time points (mean of -50, range of -47.2 to -53.6).  Conclusions:  We found no significant effect of intranasal steroids on nasal obstruction as compared with placebo. Surgery, however, was associated with significant sustained improvement in nasal obstruction. These data suggest that in patients with nasal obstruction due to a fixed cause, medical therapy with intranasal steroids is unlikely to be beneficial.",2020,There was no significant difference in mean NOSE scores in either group from baseline to the completion of the first and second study drugs.,"['Nasal Obstruction in Septal Deviation', 'patients with nasal obstruction', 'Results:  Forty-two patients completed both study drugs with NOSE scores collected']","['intranasal steroids', 'intranasal steroids versus placebo', 'Nasal Steroids', 'therapy with Nasacort (Chattem, Inc.) and with Ayr saline spray (B.F. Ascher', 'placebo']","['mean NOSE scores', 'mean NOSE score', 'NOSE score', 'baseline demographics', 'Nasal Obstruction Symptom Evaluation (NOSE) scores', 'nasal obstruction', 'postoperative NOSE scores']","[{'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0594040', 'cui_str': 'Nasacort'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",42.0,0.347848,There was no significant difference in mean NOSE scores in either group from baseline to the completion of the first and second study drugs.,"[{'ForeName': 'Shannon F', 'Initials': 'SF', 'LastName': 'Rudy', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Cherian', 'Initials': 'C', 'LastName': 'Kandathil', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Spataro', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Sami P', 'Initials': 'SP', 'LastName': 'Moubayed', 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Montreal, Montréal, Canada.'}, {'ForeName': 'Sam P', 'Initials': 'SP', 'LastName': 'Most', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA.'}]",Facial plastic surgery & aesthetic medicine,['10.1089/fpsam.2020.0150']
2449,32423392,Effect of feeding mode on infant growth and cognitive function: study protocol of the Chilean infant Nutrition randomized controlled Trial (ChiNuT).,"BACKGROUND


A central aim for pediatric nutrition is to develop infant formula compositionally closer to human milk. Milk fat globule membranes (MFGM) have shown to have functional components that are found in human milk, suggesting that addition of bovine sources of MFGM (bMFGM) to infant formula may promote beneficial outcomes potentially helping to narrow the gap between infants who receive human breast milk or infant formula. The objective of the current study is to determine how the addition of bMFGM in infant formula and consumption in early infancy affects physical growth and brain development when compared to infants fed with a standard formula and a reference group of infants fed with mother's own milk.
METHODS


Single center, double-blind, and parallel randomized controlled trial. Planned participant enrollment includes: infants exclusively receiving breast milk (n = 200; human milk reference group; HM) and infants whose mothers chose to initiate exclusive infant formula feeding before 4 months of age (n = 340). The latter were randomized to receive one of two study formulas until 12 months of age: 1) cow's milk based infant formula that had docosahexaenoic (DHA) (17 mg/100 kcal) and arachidonic acid (ARA) (25 mg/100 kcal); 1.9 g protein/100 kcal; 1.2 mg Fe/100 kcal (Standard formula; SF) or 2) a similar infant formula with an added source of bovine MFGM (whey protein-lipid concentrate (Experimental formula; EF). Primary outcomes will be: 1) Physical growth (Body weight, length, and head circumference) at 730 days of age; and 2) Cognitive development (Auditory Event-Related Potential) at 730 days of age. Data will be analyzed for all participants allocated to each study feeding group.
DISCUSSION


The results of this study will complement the knowledge regarding addition of bMFGM in infant formula including support of healthy growth and improvement of neurodevelopmental outcomes.
TRIAL REGISTRATION


NCT02626143, registered on December 10th 2015.",2020,The latter were randomized to receive one of two study formulas until 12 months of age: 1) cow's milk based infant formula that had docosahexaenoic (DHA) (17 mg/100 kcal) and arachidonic acid (ARA) (25 mg/100 kcal); 1.9 g protein/100 kcal; 1.2 mg Fe/100 kcal (Standard formula; SF) or 2) a similar infant formula with an added source of bovine MFGM (whey protein-lipid concentrate (Experimental formula; EF).,"[""infants fed with a standard formula and a reference group of infants fed with mother's own milk"", 'infants who receive human breast milk or infant formula']","['arachidonic acid (ARA) (25\u2009mg/100\u2009kcal); 1.9\u2009g protein/100\u2009kcal; 1.2\u2009mg Fe/100\u2009kcal (Standard formula; SF) or 2) a similar infant formula with an added source of bovine MFGM (whey protein-lipid concentrate (Experimental formula; EF', 'Planned participant enrollment includes: infants exclusively receiving breast milk (n\u2009=\u2009200; human milk reference group; HM', ""cow's milk based infant formula that had docosahexaenoic (DHA"", 'Milk fat globule membranes (MFGM', 'feeding mode', 'bMFGM']","['infant growth and cognitive function', '1) Physical growth (Body weight, length, and head circumference) at 730\u2009days of age; and 2) Cognitive development (Auditory Event-Related Potential']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}]","[{'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0670751', 'cui_str': 'milk fat globule'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0388561', 'cui_str': 'MFGE8 protein, human'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}]",,0.14066,The latter were randomized to receive one of two study formulas until 12 months of age: 1) cow's milk based infant formula that had docosahexaenoic (DHA) (17 mg/100 kcal) and arachidonic acid (ARA) (25 mg/100 kcal); 1.9 g protein/100 kcal; 1.2 mg Fe/100 kcal (Standard formula; SF) or 2) a similar infant formula with an added source of bovine MFGM (whey protein-lipid concentrate (Experimental formula; EF).,"[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Toro-Campos', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Av El Libano 5524, Macul, Santiago, Chile. rosario.toro@inta.uchile.cl.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Algarín', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Av El Libano 5524, Macul, Santiago, Chile.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Peirano', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Av El Libano 5524, Macul, Santiago, Chile.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Peña', 'Affiliation': 'Psychology Department, Pontific Catholic University, Santiago, Chile.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Murguia-Peniche', 'Affiliation': 'Medical Affairs, Mead Johnson Nutrition, Evansville, IN, USA.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Wu', 'Affiliation': 'Medical Affairs, Mead Johnson Nutrition, Evansville, IN, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Uauy', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Av El Libano 5524, Macul, Santiago, Chile.'}]",BMC pediatrics,['10.1186/s12887-020-02087-9']
2450,32423235,The Effects of Listening to Music on Breast Milk Production by Mothers of Premature Newborns in the Neonatal Intensive Care Unit: A Randomized Controlled Study.,"Objective:  This study was a randomized controlled experiment to determine the effects of listening to music on breast milk production in Turkish mothers with premature newborns.  Methods:  The study consisted of two groups of randomly selected mothers ( n  = 20 each) of newborns in the neonatal intensive care unit (NICU) of two university hospitals in Istanbul between November 2017 and November 2018. On the first day, all mothers were provided with training for milking with pumps. On the second through fourth days, mothers in the music group (MG) underwent two sessions of milking with music and a pump for 15 minutes at 11:00 and 16:00; the mothers in the control group underwent two sessions of milking without music. To evaluate stress levels, Spielberger's State-Trait Anxiety Inventory was administered and salivary cortisol tests were taken on the first and final days of the study.  Results:  The mean age of participants was 28.5 ± 5.3 years, the mean gestational week was 32.21 ± 2.26, and the mean birth weight of the newborns was 1748 ± 533.4 g. The state and total anxiety scores of the MG were statistically low ( p  < 0.05). There was no difference between the MG and control group in the amount of breast milk produced; however, the final test cortisol levels of the MG group were significantly lower compared with the pretest measurements ( p  < 0.05).  Conclusion:  Listening to music in the NICU while breastfeeding can help reduce stress levels in mothers to premature newborns and support breast milk production.",2020,"There was no difference between the MG and control group in the amount of breast milk produced; however, the final test cortisol levels of the MG group were significantly lower compared with the pretest measurements ( p  < 0.05).  ","['The mean age of participants was 28.5\u2009±\u20095.3 years, the mean gestational week was 32.21\u2009±\u20092.26, and the mean birth weight of the newborns was 1748\u2009±\u2009533.4', 'mothers to premature newborns', 'Turkish mothers with premature newborns', 'randomly selected mothers ( n \u2009=\u200920 each) of newborns in the neonatal intensive care unit (NICU) of two university hospitals in Istanbul between November 2017 and November 2018', 'Mothers of Premature Newborns in the Neonatal Intensive Care Unit']","['listening to music', 'Listening to Music']","['breast milk production', ""stress levels, Spielberger's State-Trait Anxiety Inventory"", 'stress levels', 'final test cortisol levels', 'state and total anxiety scores']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0233315', 'cui_str': 'Premature birth of newborn'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0362383,"There was no difference between the MG and control group in the amount of breast milk produced; however, the final test cortisol levels of the MG group were significantly lower compared with the pretest measurements ( p  < 0.05).  ","[{'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Varişoğlu', 'Affiliation': 'Depertmant of Nursing, Faculty of Health Science, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Ilkay', 'Initials': 'I', 'LastName': 'Güngör Satilmiş', 'Affiliation': ""İlkay Güngör Satilmiş's Institution, Florence Nightingale Faculty of Nursing, Istanbul University Cerrahpasa, Istanbul, Turkey.""}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0027']
2451,32423331,Glutamate levels and perfusion in pons during migraine attacks: A 3T MRI study using proton spectroscopy and arterial spin labeling.,"Migraine is a complex disorder, involving peripheral and central brain structures, where mechanisms and site of attack initiation are an unresolved puzzle. While abnormal pontine neuronal activation during migraine attacks has been reported, exact implication of this finding is unknown. Evidence suggests an important role of glutamate in migraine, implying a possible association of pontine hyperactivity to increased glutamate levels. Migraine without aura patients were scanned during attacks after calcitonin gene-related peptide and sildenafil in a double-blind, randomized, double-dummy, cross-over design, on two separate study days, by proton magnetic resonance spectroscopy and pseudo-continuous arterial spin labeling at 3T. Headache characteristics were recorded until 24 h after drug administrations. Twenty-six patients were scanned during migraine, yielding a total of 41 attacks. Cerebral blood flow increased in dorsolateral pons, ipsilateral to pain side during attacks, compared to outside attacks (13.6%, p = 0.009). Glutamate levels in the same area remained unchanged during attacks (p = 0.873), while total creatine levels increased (3.5%, p = 0.041). In conclusion, dorsolateral pontine activation during migraine was not associated with higher glutamate levels. However, the concurrently increased total creatine levels may suggest an altered energy metabolism, which should be investigated in future studies to elucidate the role of pons in acute migraine.",2020,"Glutamate levels in the same area remained unchanged during attacks (p = 0.873), while total creatine levels increased (3.5%, p = 0.041).","['Twenty-six patients were scanned during migraine, yielding a total of 41 attacks', 'pons during migraine attacks']","['calcitonin gene-related peptide and sildenafil', 'Migraine', 'proton spectroscopy and arterial spin labeling']","['Cerebral blood flow', 'total creatine levels', 'Glutamate levels']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0032639', 'cui_str': 'Pontine structure'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}]",26.0,0.178407,"Glutamate levels in the same area remained unchanged during attacks (p = 0.873), while total creatine levels increased (3.5%, p = 0.041).","[{'ForeName': 'Samaira', 'Initials': 'S', 'LastName': 'Younis', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Casper E', 'Initials': 'CE', 'LastName': 'Christensen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Vestergaard', 'Affiliation': 'Functional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Lindberg', 'Affiliation': 'Functional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tolnai', 'Affiliation': 'Department of Radiology, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Olaf B', 'Initials': 'OB', 'LastName': 'Paulson', 'Affiliation': 'Neurobiology Research Unit, Department of Neurology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henrik Bw', 'Initials': 'HB', 'LastName': 'Larsson', 'Affiliation': 'Functional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hougaard', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Glostrup, Denmark.'}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X20906902']
2452,32423429,"Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study.","BACKGROUND


Cold hypersensitivity in the hands and feet (CHHF) commonly affects Asian women, especially Korean women, and it negatively impacts the quality of life of the affected individuals. One commonly used herbal prescription for treating CHHF is Onkyeong-tang (OKT). Although OKT is widely used clinically in treating CHHF, no randomized clinical trial has been performed to evaluate the efficacy and safety of OKT in the treatment of cold hypersensitivity in the feet (CHF). This clinical trial aims to provide objective evidence for the basis of using OKT in the treatment of CHF in Korean women.
METHODS


This trial will be a double-blind, randomized, placebo-controlled, parallel-group, multicenter pilot study. A total of 112 participants will be randomly divided into an OKT treatment group or a placebo group with a 1:1 ratio via a web-based randomization system. The OKT and placebo groups will receive prescribed medications orally three times per day (3 g each time) before or between meals for 8 weeks. The primary outcome studied will be the changes in Visual Analog Scale (VAS) scores of CHF from baseline. Secondary outcomes studied will be the VAS score changes of cold hypersensitivity in the hands, changes in the skin temperature of the hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale-abbreviated version, and the results of the cold stress test.
DISCUSSION


This trial will be the first clinical trial to assess the efficacy and safety of OKT in the treatment of CHF. We anticipate that the findings of the study will provide evidence for the basis of using OKT in treating CHF symptoms and generate basic data for designing a further large-scale randomized clinical trial.
TRIAL REGISTRATION


Clinical Research Information Service (CRIS): KCT0003723. Retrospectively registered on 8 April 2019.",2020,"Secondary outcomes studied will be the VAS score changes of cold hypersensitivity in the hands, changes in the skin temperature of the hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale-abbreviated version, and the results of the cold stress test.
","['112 participants', 'feet of Korean women', 'hands and feet (CHHF) commonly affects Asian women, especially Korean women', 'Korean women']","['OKT and placebo', 'OKT', 'Onkyeong-tang', 'OKT treatment', 'placebo']","['efficacy and safety', 'Efficacy and safety', 'VAS score changes of cold hypersensitivity in the hands, changes in the skin temperature of the hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale-abbreviated version, and the results of the cold stress test', 'Visual Analog Scale (VAS) scores of CHF']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0343068', 'cui_str': 'Familial cold urticaria'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0343068', 'cui_str': 'Familial cold urticaria'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4704948', 'cui_str': 'Cold Shock'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",112.0,0.4159,"Secondary outcomes studied will be the VAS score changes of cold hypersensitivity in the hands, changes in the skin temperature of the hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale-abbreviated version, and the results of the cold stress test.
","[{'ForeName': 'Kyou-Young', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Otolaryngology, Dermatology, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea.'}, {'ForeName': 'In-Sik', 'Initials': 'IS', 'LastName': 'Han', 'Affiliation': 'Department of Korean Internal Medicine, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea.'}, {'ForeName': 'Ho-Yeon', 'Initials': 'HY', 'LastName': 'Go', 'Affiliation': 'Department of Korean Internal Medicine, College of Korean Medicine, Semyung University, 65 Semyeong-ro, Jecheon-si, Chungcheongbuk-do, Republic of Korea.'}, {'ForeName': 'Dong-Nyung', 'Initials': 'DN', 'LastName': 'Lee', 'Affiliation': 'Department of Gynecology Medicine, College of Korean Medicine, Semyung University, 63 Sangbang 4-gil, Chungju-si, Chungcheongbuk-do, Republic of Korea.'}, {'ForeName': 'Jun-Sang', 'Initials': 'JS', 'LastName': 'Yu', 'Affiliation': 'Department of Sasang Constitutional Medicine, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea. hiruok@sangji.ac.kr.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Sun', 'Affiliation': 'Department of Korean Internal Medicine, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea. sunguy2001@hanmail.net.'}]",Trials,['10.1186/s13063-020-04265-7']
2453,32423275,Pharmacokinetic Study of Epinephrine Hydrofluoroalkane (Primatene MIST) Metered-Dose Inhaler.,"Background :  Primatene ®  MIST CFC, an epinephrine metered-dose inhaler (MDI), was discontinued from the market owing to environmental concerns from its use of chlorofluorocarbon (CFC) propellant. As a result, a new epinephrine MDI was developed using hydrofluoroalkane (HFA) propellant. This article reports the pharmacokinetic (PK) profile of the newly Food and Drug Administration-approved epinephrine HFA MDI.  Methods :  A randomized, evaluator-blinded, active-controlled, single-dose, two-arm crossover study was conducted to evaluate the PK profile of epinephrine HFA (Primatene ®  MIST) and epinephrine CFC (Primatene ®  MIST CFC) in 23 healthy volunteers to characterize the epinephrine absorption extent and rate. The study was performed at a high dose of five times the normal dose to obtain measurable plasma epinephrine levels. Plasma epinephrine levels were measured and safety was assessed by adverse events (AEs), vital signs, clinical laboratory tests, and physical examinations.  Results : Epinephrine HFA demonstrated a greater systemic drug exposure (greater area under the curve) than that of epinephrine CFC (∼37% higher). The  C max  occurred at ∼2 minutes and was significantly higher in the epinephrine HFA group (0.18 ng/mL) compared with the CFC version (0.046 ng/mL) at normal dose. Within 20 minutes, both groups demonstrated comparable plasma epinephrine levels. No clinically significant adverse effects were found to be associated with epinephrine HFA, even after an ultrahigh dose (i.e., 10 inhalations).  Conclusions:  The systemic exposure of epinephrine HFA was found to be higher for the first 20 minutes, and then comparable with epinephrine CFC. Minimal AEs were found in this study despite the very high 1250-2200 μg inhaled doses (i.e., 10 inhalations) used for PK characterization.",2020,Epinephrine HFA demonstrated a greater systemic drug exposure (greater area under the curve) than that of epinephrine CFC (∼37% higher).,['23 healthy volunteers'],"['epinephrine metered-dose inhaler (MDI', 'chlorofluorocarbon (CFC) propellant', 'hydrofluoroalkane (HFA) propellant', 'epinephrine HFA (Primatene ®  MIST) and epinephrine CFC (Primatene ®  MIST CFC', 'epinephrine HFA', 'Epinephrine Hydrofluoroalkane (Primatene MIST', 'epinephrine CFC', 'Epinephrine HFA']","['adverse events (AEs), vital signs, clinical laboratory tests, and physical examinations', 'plasma epinephrine levels', 'systemic drug exposure', 'Plasma epinephrine levels', 'adverse effects', 'C max']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0162787', 'cui_str': 'Chlorofluorocarbon'}, {'cui': 'C0015458', 'cui_str': 'Facial hemiatrophy'}, {'cui': 'C0722799', 'cui_str': 'Primatene'}, {'cui': 'C1275081', 'cui_str': 'Cardio-facio-cutaneous syndrome'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1275469', 'cui_str': 'Plasma epinephrine measurement'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",23.0,0.141648,Epinephrine HFA demonstrated a greater systemic drug exposure (greater area under the curve) than that of epinephrine CFC (∼37% higher).,"[{'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, Medford, Oregon, USA.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Marrs', 'Affiliation': 'Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California, USA.'}, {'ForeName': 'Mary Z', 'Initials': 'MZ', 'LastName': 'Luo', 'Affiliation': 'Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California, USA.'}, {'ForeName': 'Jack Y', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California, USA.'}]",Journal of aerosol medicine and pulmonary drug delivery,['10.1089/jamp.2019.1577']
2454,32423348,Associations Between Dietary Patterns and Subclinical Cardiac Injury.,"BACKGROUND


The DASH diet has been found to lower blood pressure (BP) and low-density lipoprotein cholesterol levels.
OBJECTIVE


To compare diets rich in fruits and vegetables with a typical American diet in their effects on cardiovascular injury in middle-aged adults without known preexisting cardiovascular disease (CVD).
DESIGN


Observational study based on a 3-group, parallel-design, randomized trial conducted in the United States from 1994 to 1996. (ClinicalTrials.gov: NCT00000544).
SETTING


3 of the 4 original clinical trial centers.
PARTICIPANTS


326 of the original 459 trial participants with available stored specimens.
INTERVENTION


Participants were randomly assigned to 8 weeks of monitored feeding with a control diet typical of what many Americans eat; a diet rich in fruits and vegetables but otherwise similar to the control diet; or the DASH diet, which is rich in fruits, vegetables, low-fat dairy, and fiber and has low levels of saturated fat and cholesterol. Weight was kept constant throughout feeding.
MEASUREMENTS


Biomarkers collected at baseline and 8 weeks: high-sensitivity cardiac troponin I (hs-cTnI),  N -terminal pro-B-type natriuretic peptide (NT-proBNP), and high-sensitivity C-reactive protein (hs-CRP).
RESULTS


The mean age of participants was 45.2 years, 48% were women, 49% were black, and mean baseline BP was 131/85 mm Hg. Compared with the control diet, the fruit-and-vegetable diet reduced hs-cTnI levels by 0.5 ng/L (95% CI, -0.9 to -0.2 ng/L) and NT-proBNP levels by 0.3 pg/mL (CI, -0.5 to -0.1 pg/mL). Compared with the control diet, the DASH diet reduced hs-cTnI levels by 0.5 ng/L (CI, -0.9 to -0.1 ng/L) and NT-proBNP levels by 0.3 pg/mL (CI, -0.5 to -0.04 pg/mL). Levels of hs-CRP did not differ among diets. None of the markers differed between the fruit-and-vegetable and DASH diets.
LIMITATION


Short duration, missing specimens, and an inability to isolate the effects of specific foods or micronutrients.
CONCLUSION


Diets rich in fruits and vegetables given over 8 weeks were associated with lower levels of markers for subclinical cardiac damage and strain in adults without preexisting CVD.
PRIMARY FUNDING SOURCE


National Institutes of Health, National Heart, Lung, and Blood Institute.",2020,"Diets rich in fruits and vegetables given over 8 weeks were associated with lower levels of markers for subclinical cardiac damage and strain in adults without preexisting CVD.
","['middle-aged adults without known preexisting cardiovascular disease (CVD', '3 of the 4 original clinical trial centers', '326 of the original 459 trial participants with available stored specimens', 'United States from 1994 to 1996', 'The mean age of participants was 45.2 years, 48% were women, 49% were black, and mean baseline BP was 131/85 mm Hg', 'adults without preexisting CVD']","['diets rich in fruits and vegetables with a typical American diet', 'control diet typical of what many Americans eat; a diet rich in fruits and vegetables but otherwise similar to the control diet; or the DASH diet']","['blood pressure (BP) and low-density lipoprotein cholesterol levels', 'cardiovascular injury', 'NT-proBNP levels', 'hs-cTnI levels', 'Weight', 'Levels of hs-CRP', 'high-sensitivity cardiac troponin']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0560570', 'cui_str': 'Cardiovascular injury'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]",,0.0964925,"Diets rich in fruits and vegetables given over 8 weeks were associated with lower levels of markers for subclinical cardiac damage and strain in adults without preexisting CVD.
","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (S.P.J., K.J.M.).'}, {'ForeName': 'Lara C', 'Initials': 'LC', 'LastName': 'Kovell', 'Affiliation': 'University of Massachusetts Medical School, Worcester, Massachusetts (L.C.K.).'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland (L.J.A., E.R.M.).'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland (L.J.A., E.R.M.).'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': ""Harvard T.H. Chan School of Public Health, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts (F.M.S.).""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Christenson', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland (R.H.C., H.R.).'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Rebuck', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland (R.H.C., H.R.).'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Chang', 'Affiliation': 'Geisinger Health System, Danville, Pennsylvania (A.R.C.).'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (S.P.J., K.J.M.).'}]",Annals of internal medicine,['10.7326/M20-0336']
2455,32423446,A music- and game-based oral health education for visually impaired school children; multilevel analysis of a cluster randomized controlled trial.,"BACKGROUND


Visually impaired children encounter some challenges for their oral health. We aimed to compare the effectiveness of oral health education using Audio Tactile Performance (ATP) technique alone, ATP combined with oral health education for mothers, and ATP along with art package on the oral health status of visually impaired children.
MATERIALS AND METHODS


This cluster, randomized trial, included visually impaired children from preschool to 10th grade (32 classes, n = 200), in Tehran, Iran, in 2018-2019. A questionnaire was filled out through face to face interviews at baseline regarding age, gender, status of visual impairment, and place of residence. The Simplified Oral Hygiene Index (OHI-S) and Bleeding on Probing (BOP) were examined afterward. Classes were randomly assigned to three groups through simple randomization: 1. Art group (ATP, game-based, and music-based education (11 classes, n = 66); 2. Mothers group (children received ATP and their mothers received education by telephone (10 classes, n = 73); and 3. Control group (children received ATP (11 classes, n = 61). Children received reinforcement after 1 and 2 weeks. Follow-up oral examinations were performed after 1 and 2 months by a blind calibrated examiner. Descriptive statistics were performed using Chi-Square, and ANOVA tests by SPSS (version 22). In analytic statistics, two-level mixed-effects models for BOP and OHI-S were fitted using the Statistical Analysis Software (SAS) version 9.4. Both models fitted with the grouping variable and time (baseline, 1, and 2 months after interventions) as the fixed effects.
RESULTS


The mean age (SD) of the children was 12.29 (3.45) years (range: 6-17). Male children (67%) more than female children (33%) participated in the study. Also, 35.5% were blind, and 12% resided at the dormitory. The art and mothers groups had no statistically significant difference compared with the control group, in terms of OHI-S (P = 0.92, and 0.39, respectively) and BOP (OR = 0.64, and 0.66, respectively). The time effect was statistically significant in both BOP and OHI-S models (P < 0.0001).
CONCLUSIONS


ATP technique is an effective method to improve the oral health status of visually impaired school children. Oral health promotion programs can be done using this method to tackle oral hygiene problems in visually impaired children.
TRIAL REGISTRATION


(https://www.irct.ir/trial/34676: Nov 29th, 2018).",2020,"The art and mothers groups had no statistically significant difference compared with the control group, in terms of OHI-S (P = 0.92, and 0.39, respectively) and BOP (OR = 0.64, and 0.66, respectively).","['included visually impaired children from preschool to 10th grade (32 classes, n\u2009=\u2009200), in Tehran, Iran, in 2018-2019', 'visually impaired children', 'Mothers group (children received', 'mothers, and ATP along with art package on the oral health status of visually impaired children', 'Male children (67%) more than female children (33%) participated in the study', 'The mean age (SD) of the children was 12.29 (3.45) years', 'visually impaired school children']","['ATP', 'oral health education using Audio Tactile Performance (ATP) technique alone, ATP combined with oral health education', 'music- and game-based oral health education']","['OHI-S', 'BOP', 'BOP and OHI-S models', 'oral health status', 'Simplified Oral Hygiene Index (OHI-S) and Bleeding on Probing (BOP', 'BOP and OHI-S']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0029165', 'cui_str': 'Oral Hygiene Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}]",,0.0972671,"The art and mothers groups had no statistically significant difference compared with the control group, in terms of OHI-S (P = 0.92, and 0.39, respectively) and BOP (OR = 0.64, and 0.66, respectively).","[{'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Sharififard', 'Affiliation': 'Research Center for Caries Prevention, Dentistry Research Institute, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Katayoun', 'Initials': 'K', 'LastName': 'Sargeran', 'Affiliation': 'Research Center for Caries Prevention, Dentistry Research Institute, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran. k-sargeran@tums.ac.ir.'}, {'ForeName': 'Mahdia', 'Initials': 'M', 'LastName': 'Gholami', 'Affiliation': 'Research Center for Caries Prevention, Dentistry Research Institute, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Zayeri', 'Affiliation': 'Proteomics Research Center and Department of Biostatistics, Faculty of Paramedical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",BMC oral health,['10.1186/s12903-020-01131-5']
2456,32423576,"Effect of tranexamic acid on blood loss after reverse total shoulder arthroplasty according to the administration method: a prospective, multicenter, randomized, controlled study.","BACKGROUND


The ideal method of administering tranexamic acid (TXA) for reverse total shoulder arthroplasty (RTSA) remains unknown. We aimed to evaluate TXA efficacy according to 3 administration methods after RTSA.
METHODS


Overall, 102 patients who underwent RTSA using a single implant between September 2016 and November 2018 were randomized to the following groups according to the TXA administration method: intravenous (n = 34; 1 g + 0.9% normal saline 100 mL), topical (n = 33; 2 g + 0.9% normal saline 50 mL), and combined groups (n = 34). Patients were enrolled in 4 tertial referral hospitals for prospective multicenter studies. The primary outcome was a hemoglobin decrease in 24 hours postoperatively; secondary outcomes were total drain volume, transfusion rate, and calculated total blood loss.
RESULTS


Demographic data, including preoperative hemoglobin levels, were not different among the 3 groups, but the average age was higher in the combined group (P = .038). Hemoglobin decrease (1.8 ± 1.1 vs. 1.8 ± 1.0 vs. 2.0 ± 1.1 g/dL, P = .769), total drain volume (209.2 ± 147.6 vs. 167.2 ± 102.0 vs. 166.0 ± 118.7, P = .270), and total blood loss (701.1 ± 352.3 vs. 656.5 ± 285.6 vs. 699.0 ± 248.7 mL, P = .810) were not significantly different among the 3 groups (all P > .05). The transfusion rate was higher in the intravenous group (n = 4), whereas only 1 patient had transfusion in the topical group and none in the combined group, although the difference was not statistically significant (P = .084).
CONCLUSION


Blood loss did not differ among TXA administration methods after RTSA. However, considering the risk of complication in intravenous TXA, topical TXA after RTSA may be safer, even for patients with normal risk for venous thromboembolic complication.",2020,"RESULTS


Demographic data, including preoperative hemoglobin levels, were not different among the 3 groups, but the average age was higher in the combined group (P = .038).","['patients with normal risk for venous thromboembolic complication', '102 patients who underwent RTSA using a single implant between September 2016 and November 2018', 'Patients were enrolled in 4 tertial referral hospitals for prospective multicenter studies']","['TXA administration method: intravenous (n = 34; 1 g + 0.9% normal saline 100 mL), topical (n = 33; 2 g + 0.9% normal saline', 'tranexamic acid (TXA', 'tranexamic acid']","['total blood loss', 'TXA efficacy', 'preoperative hemoglobin levels', 'transfusion rate', 'hemoglobin decrease', 'total drain volume', 'Hemoglobin decrease', 'total drain volume, transfusion rate, and calculated total blood loss', 'transfusion', 'blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4728044', 'cui_str': 'Reverse prosthetic total arthroplasty of shoulder'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.139374,"RESULTS


Demographic data, including preoperative hemoglobin levels, were not different among the 3 groups, but the average age was higher in the combined group (P = .038).","[{'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Yoon', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Bundang Jesaeng General Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Yang Soo', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': ""Catholic University College of Medicine, Seoul St. Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Sang Jin', 'Initials': 'SJ', 'LastName': 'Shin', 'Affiliation': 'Ewha Womans University College of Medicine, Ewha Womans University Seoul Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Chul', 'Initials': 'JC', 'LastName': 'Yoo', 'Affiliation': 'Sungkyunkwan University College of Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Joo Han', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. Electronic address: ohjh1@snu.ac.kr.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.02.013']
2457,32423462,"Efficacy of extended infusion of β-lactam antibiotics for the treatment of febrile neutropenia in haematologic patients: protocol for a randomised, multicentre, open-label, superiority clinical trial (BEATLE).","BACKGROUND


Febrile neutropaenia (FN) is a very common complication in patients with haematological malignancies and is associated with considerable morbidity and mortality. Broad-spectrum antipseudomonal β-lactam antibiotics (BLA) are routinely used for the treatment of cancer patients with FN. However, the clinical efficacy of BLA may be diminished in these patients because they present with pathophysiological variations that compromise the pharmacokinetic (PK) parameters of these antibiotics. Optimised administration of BLA in prolonged infusions has demonstrated better clinical outcomes in critically ill patients. However, there is a paucity of data on the usefulness of this strategy in patients with FN. The aim of this study is to test the hypothesis that the administration of BLA would be clinically more effective by extended infusion (EI) than by intermittent infusion (II) in haematological patients with FN.
METHODS


A randomised, multicentre, open-label, superiority clinical trial will be performed. Patients with haematological malignancies undergoing chemotherapy or haematopoietic stem-cell transplant and who have FN and receive empirical antibiotic therapy with cefepime, piperacillin-tazobactam or meropenem will be randomised (1:1) to receive the antibiotic by EI (during half the time of the dosing interval) in the study group, or by II (30 min) in the control group. The primary endpoint will be clinical efficacy, defined as defervescence without modifying the antibiotic treatment administered within the first 5 days of therapy. The primary endpoint will be analysed in the intention-to-treat population. The secondary endpoints will be pharmacokinetic/pharmacodynamic (PK/PD) target achievement, bacteraemia clearance, decrease in C-reactive protein, overall (30-day) case-fatality rate, adverse events and development of a population PK model of the BLA studied.
DISCUSSION


Data on the usefulness of BLA administration in patients with FN are scant. Only three clinical studies addressing this issue have been published thus far, with contradictory results. Moreover, these studies had some methodological flaws that limit the interpretation of their findings. If this randomised, multicentre, phase IV, open-label, superiority clinical trial validates the hypothesis that the administration of BLA is clinically more effective by EI than by II in haematological patients with FN, then the daily routine management of these high-risk patients could be changed to improve their outcomes.
TRIAL REGISTRATION


European Clinical Trials Database: EudraCT 2018-001476-37. ClinicalTrials.gov, ID: NCT04233996.",2020,Broad-spectrum antipseudomonal β-lactam antibiotics (BLA) are routinely used for the treatment of cancer patients with FN.,"['patients with FN are scant', 'Patients with haematological malignancies undergoing chemotherapy or haematopoietic stem-cell transplant and who have FN and receive empirical', 'cancer patients with FN', 'critically ill patients', 'haematological patients with FN', 'patients with haematological malignancies', 'patients with FN', 'febrile neutropenia in haematologic patients']","['antibiotic therapy with cefepime, piperacillin-tazobactam or meropenem', 'Broad-spectrum antipseudomonal β-lactam antibiotics (BLA', 'β-lactam antibiotics', 'BLA']","['intention-to-treat population', 'pharmacokinetic/pharmacodynamic (PK/PD) target achievement, bacteraemia clearance, decrease in C-reactive protein, overall (30-day) case-fatality rate, adverse events and development of a population PK model of the BLA studied', 'clinical efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0205488', 'cui_str': 'Hematologic'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0055003', 'cui_str': 'cefepime'}, {'cui': 'C0250480', 'cui_str': 'Piperacillin and tazobactam'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0022914', 'cui_str': 'Lactam'}]","[{'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0282250', 'cui_str': 'Case fatality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0022914', 'cui_str': 'Lactam'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",,0.151928,Broad-spectrum antipseudomonal β-lactam antibiotics (BLA) are routinely used for the treatment of cancer patients with FN.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Laporte-Amargos', 'Affiliation': ""Infectious Diseases Department Hospital Universitari Bellvitge, Institut d'Investigació Biomedica de Bellvitge (IDIBELL), Feixa Llarga SN, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gudiol', 'Affiliation': ""Infectious Diseases Department Hospital Universitari Bellvitge, Institut d'Investigació Biomedica de Bellvitge (IDIBELL), Feixa Llarga SN, 08907, L'Hospitalet de Llobregat, Barcelona, Spain. carlotagudiol@gmail.com.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arnan', 'Affiliation': ""Clinical Haematology Department, Institut Català d'Oncologia-Hospitalet, IDIBELL, Barcelona, Spain.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Puerta-Alcalde', 'Affiliation': ""Infectious Diseases Department, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Hospital Clínic i Provincial de Barcelona, Barcelona, Spain.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Carmona-Torre', 'Affiliation': 'Infectious Diseases Department, Clínica Universidad de Navarra, Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Huguet', 'Affiliation': ""Clinical Haematology Department, Institut Català d'Oncologia-Badalona, Institut Josep Carreras (IJC), Hospital Germans Trias i Pujol, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Albasanz-Puig', 'Affiliation': ""Infectious Diseases Department Hospital Universitari Bellvitge, Institut d'Investigació Biomedica de Bellvitge (IDIBELL), Feixa Llarga SN, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Parody', 'Affiliation': ""Clinical Haematology Department, Institut Català d'Oncologia-Hospitalet, IDIBELL, Barcelona, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Garcia-Vidal', 'Affiliation': ""Infectious Diseases Department, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Hospital Clínic i Provincial de Barcelona, Barcelona, Spain.""}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Del Pozo', 'Affiliation': 'Infectious Diseases Department, Clínica Universidad de Navarra, Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Batlle', 'Affiliation': ""Clinical Haematology Department, Institut Català d'Oncologia-Badalona, Institut Josep Carreras (IJC), Hospital Germans Trias i Pujol, Barcelona, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tebé', 'Affiliation': 'Biostatistics Unit, IDIBELL, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rigo-Bonnin', 'Affiliation': 'Clinical Laboratory Department, Hospital Universitari Bellvitge, IDIBELL, Barcelona, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Muñoz', 'Affiliation': ""Pharmacy Department, Clinical Trial Unit, Institut Català d'Oncologia, IDIBELL, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Padullés', 'Affiliation': 'Pharmacy Department, Hospital Universitari Bellvitge, IDIBELL, Barcelona, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Tubau', 'Affiliation': 'Microbiology Department, Hospital Universitari Bellvitge, IDIBELL, Barcelona, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Videla', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitari Bellvitge, IDIBELL, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sureda', 'Affiliation': ""Clinical Haematology Department, Institut Català d'Oncologia-Hospitalet, IDIBELL, Barcelona, Spain.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Carratalà', 'Affiliation': ""Infectious Diseases Department Hospital Universitari Bellvitge, Institut d'Investigació Biomedica de Bellvitge (IDIBELL), Feixa Llarga SN, 08907, L'Hospitalet de Llobregat, Barcelona, Spain.""}]",Trials,['10.1186/s13063-020-04323-0']
2458,32423454,"Neck-specific strengthening exercise compared with sham ultrasound when added to home-stretching exercise in patients with migraine: study protocol of a two-armed, parallel-groups randomized controlled trial.","BACKGROUND


Migraine is a highly disabling condition and pharmacological treatment is the gold standard. However, several patients have also positive responses to the application of different manual techniques and therapeutic exercises in terms of reducing the intensity and frequency of migraine attacks. Nevertheless, the effects of a neck-specific exercise program have not yet been evaluated in these patients.
OBJECTIVE


To determine the effectiveness of a neck-specific exercise program in reducing the intensity and frequency of migraine attacks as compared to a sham ultrasound group.
METHODS


A two-armed, parallel-groups randomized controlled trial with 3 months of follow-up will be conducted. 42 individuals, both genders, aged between 18 and 55 years old with a medical diagnosis of migraine will be included. The intervention group will perform a protocol consisting of exercises for strengthening the muscles of the cervical spine. Participants within the sham ultrasound group will receive detuned ultrasound therapy in the upper trapezius muscle. Both groups will receive a weekly session for 8 weeks. The efficacy of each intervention will be measured by the frequency and intensity of migraine at a 3-months follow-up.
TRIAL REGISTRATION


This study was registered under access code RBT-8gfv5j in the Registro Brasileiro de Ensaios Clínicos (ReBEC) in November 28, 2016.
CONCLUSION


This study will aim to determine the efficacy of a neck-specific exercise program in reducing the frequency and intensity of migraine attacks. If the results show that a neck-specific exercise program is effective in reducing the frequency and intensity of migraine attacks, therapists will have a low cost and easily applicable tool to treat migraine.",2020,"The efficacy of each intervention will be measured by the frequency and intensity of migraine at a 3-months follow-up.
","['patients with migraine', '42 individuals, both genders, aged between 18 and 55\u2009years old with a medical diagnosis of migraine will be included']","['sham ultrasound when added to home-stretching exercise', 'sham ultrasound group will receive detuned ultrasound therapy', 'neck-specific exercise program', 'Neck-specific strengthening exercise']","['frequency and intensity of migraine attacks', 'intensity and frequency of migraine attacks']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",,0.0880203,"The efficacy of each intervention will be measured by the frequency and intensity of migraine at a 3-months follow-up.
","[{'ForeName': 'Mariana Tedeschi', 'Initials': 'MT', 'LastName': 'Benatto', 'Affiliation': 'Department of Health Sciences - Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes Avenue - Monte Alegre, Ribeirão Preto, SP, 14049-900, Brazil. mariana.benatto@gmail.com.'}, {'ForeName': 'Lidiane Lima', 'Initials': 'LL', 'LastName': 'Florencio', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'Marcela Mendes', 'Initials': 'MM', 'LastName': 'Bragatto', 'Affiliation': 'Department of Health Sciences - Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes Avenue - Monte Alegre, Ribeirão Preto, SP, 14049-900, Brazil.'}, {'ForeName': 'Fabíola', 'Initials': 'F', 'LastName': 'Dach', 'Affiliation': 'Department of Neurosciences and Behavioral Sciences - Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Bevilaqua-Grossi', 'Affiliation': 'Department of Health Sciences - Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes Avenue - Monte Alegre, Ribeirão Preto, SP, 14049-900, Brazil.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00313-w']
2459,32423512,"Efficacy and Safety of Dasotraline in Adults with Binge-Eating Disorder: A Randomized, Placebo-controlled, Fixed-dose Clinical Trial.",,2020,,['Adults with Binge-Eating Disorder'],"['Placebo', 'Dasotraline']",['Efficacy and Safety'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4276542', 'cui_str': '4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.635752,,"[{'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': ''}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': ''}, {'ForeName': 'James I', 'Initials': 'JI', 'LastName': 'Hudson', 'Affiliation': ''}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Tsai', 'Affiliation': ''}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Navia', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldman', 'Affiliation': ''}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Kent', 'Affiliation': ''}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Loebel', 'Affiliation': ''}]",CNS spectrums,['10.1017/S1092852920001406']
2460,32423463,Effect of an interprofessional care concept on the hospitalization of nursing home residents: study protocol for a cluster-randomized controlled trial.,"BACKGROUND


The rising number of nursing home (NH) residents and their increasingly complex treatment needs pose a challenge to the German health care system. In Germany, there is no specialized geriatric medical care for NH residents. Nursing staff and general practitioners (GPs) in particular have to compensate for the additional demand, which is compounded by organizational and structural hurdles. As a result, avoidable emergency calls and hospital admissions occur. In the SaarPHIR project (Saarländische PflegeHeimversorgung Integriert Regelhaft), a complex intervention focusing on a medical care concept was developed in a participatory practice-based approach involving NH representatives and GPs. The complex intervention addresses the collaboration between nurses and GPs and aims to help restructure and optimize the existing daily care routine. It is expected to improve the medical care of geriatric patients in NHs and reduce stressful, costly hospital admissions. The intervention was pilot-tested during the first 12 months of the project. In the present study, its effectiveness, cost-effectiveness, and safety will be evaluated.
METHODS


The study is a cluster-randomized controlled trial, comparing an intervention group with a control group. The intervention includes a concept of interprofessional collaboration, in which GPs group into regional cooperating teams. Teams are encouraged to cooperate more closely with NH staff and to provide on-call schedules, pre-weekend visits, joint team meetings, joint documentation, and improved medication safety. At least 32 NHs in Saarland, Germany (with at least 50 residents each) will be included and monitored for 12 months. The primary endpoint is hospitalization. Secondary endpoints are quality of life, quality of care, and medication safety. The control group receives treatment as usual. Process evaluation and health economic evaluation accompany the study. The data set contains claims data from German statutory health insurance companies as well as primary data. Analysis will be conducted using a generalized linear mixed model.
CONCLUSION


A reduction in hospital admissions of NH residents and relevant changes in secondary endpoints are expected. In turn, these will have a positive impact on the economic assessment.
TRIAL REGISTRATION


German Clinical Trials Register: DRKS00017129. Registered on 23 April 2019. https://www.drks.de/drks_web/setLocale_EN.do.",2020,A reduction in hospital admissions of NH residents and relevant changes in secondary endpoints are expected.,['nursing home residents'],['interprofessional care concept'],"['hospitalization', 'effectiveness, cost-effectiveness, and safety', 'hospital admissions', 'quality of life, quality of care, and medication safety']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",[],"[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.0595669,A reduction in hospital admissions of NH residents and relevant changes in secondary endpoints are expected.,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Piotrowski', 'Affiliation': 'University of Wuppertal, Wuppertal, Germany. piotrowski@wiwi.uni-wuppertal.de.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'University of Applied Sciences Saarbrücken, Saarbrücken, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Burkholder', 'Affiliation': 'University of Applied Sciences Saarbrücken, Saarbrücken, Germany.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Renaud', 'Affiliation': 'University of Applied Sciences Saarbrücken, Saarbrücken, Germany.'}, {'ForeName': 'Markus Alexander', 'Initials': 'MA', 'LastName': 'Müller', 'Affiliation': 'Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Lehr', 'Affiliation': 'Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Laag', 'Affiliation': 'BARMER, Wuppertal, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Meiser', 'Affiliation': 'Saarland Association of Statutory Health Insurance Physicians, Saarbrücken, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Manderscheid', 'Affiliation': 'University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Köberlein-Neu', 'Affiliation': 'University of Wuppertal, Wuppertal, Germany.'}]",Trials,['10.1186/s13063-020-04325-y']
2461,32423455,The combination of methotrexate and cytosine arabinoside in newly diagnosed adult Langerhans cell histiocytosis: a prospective phase II interventional clinical trial.,"BACKGROUND


Langerhans Cell Histiocytosis (LCH) is a rare disease puzzling both children and adults, however outcome of adult patients is unfavorable. This prospective interventional trial aims to test the efficacy and safety of the combination of methotrexate and cytosine arabinoside in adult LCH patients.
METHOD


A total of 36 patients enrolled diagnosed with LCH and treated in our center from 1st Jan, 2014 to 30th Jun, 2016.
RESULT


Nineteen patients underwent the detection of BRAF mutation, with a positive rate of 21.1%. The overall response rate was 100%, only 16.7% achieved complete response. The overall regression rate of osseous lesions was 100%. Regression of central nervous system involvement was also favorable. After a median follow-up of 44 months, the estimated event-free survival was 48.9 months, the overall survival rate was 97.2%. The risk organ involvement showed strong prognostic value, EFS was 34.1 or 54.6 months (p = 0.001) in groups with/without risk organ involvement respectively. Neutropenia and thrombocytopenia were the most common adverse effects.
CONCLUSION


The regimen of methotrexate and cytosine arabinoside (MA) is effective and safe in treating adult LCH patients, and timely preventions may be considered for the high incidence of hematological adverse effects.
TRIAL REGISTRATION


Trial No. NCT02389400 on Clinicaltrials.gov, registered on 10th Mar. 2015.",2020,"The risk organ involvement showed strong prognostic value, EFS was 34.1 or 54.6 months (p = 0.001) in groups with/without risk organ involvement respectively.","['adult LCH patients', 'newly diagnosed adult Langerhans cell histiocytosis', '36 patients enrolled diagnosed with LCH and treated in our center from 1st Jan, 2014 to 30th Jun, 2016']","['methotrexate and cytosine arabinoside (MA', 'methotrexate and cytosine arabinoside', 'Langerhans Cell Histiocytosis (LCH']","['Neutropenia and thrombocytopenia', 'overall survival rate', 'efficacy and safety', 'overall response rate', 'overall regression rate of osseous lesions', 'estimated event-free survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019621', 'cui_str': 'Langerhans cell histiocytosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0162508', 'cui_str': 'jun Oncogene'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0019621', 'cui_str': 'Langerhans cell histiocytosis'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",36.0,0.186455,"The risk organ involvement showed strong prognostic value, EFS was 34.1 or 54.6 months (p = 0.001) in groups with/without risk organ involvement respectively.","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China.""}, {'ForeName': 'Mingqi', 'Initials': 'M', 'LastName': 'Ouyang', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China.""}, {'ForeName': 'Minghui', 'Initials': 'M', 'LastName': 'Duan', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China. mhduan@sina.com.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China.""}, {'ForeName': 'Tienan', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China.""}, {'ForeName': 'Shujie', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China.""}, {'ForeName': 'Daobin', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': ""Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No.1 Shuaifuyuan, Beijing, People's Republic of China.""}]",BMC cancer,['10.1186/s12885-020-06872-8']
2462,32423467,The design and statistical aspects of VIETNARMS: a strategic post-licensing trial of multiple oral direct-acting antiviral hepatitis C treatment strategies in Vietnam.,"BACKGROUND


Eliminating hepatitis C is hampered by the costs of direct-acting antiviral treatment and the need to treat hard-to-reach populations. Access could be widened by shortening or simplifying treatment, but limited research means it is unclear which approaches could achieve sufficiently high cure rates to be acceptable. We present the statistical aspects of a multi-arm trial designed to test multiple strategies simultaneously and a monitoring mechanism to detect and stop individual randomly assigned groups with unacceptably low cure rates quickly.
METHODS


The VIETNARMS trial will factorially randomly assign patients to two drug regimens, three treatment-shortening strategies or control, and adjunctive ribavirin or no adjunctive ribavirin with shortening strategies (14 randomly assigned groups). We will use Bayesian monitoring at interim analyses to detect and stop recruitment into unsuccessful strategies, defined by more than 0.95 posterior probability that the true cure rate is less than 90% for the individual randomly assigned group (non-comparative). Final comparisons will be non-inferiority for regimens (margin 5%) and strategies (margin 10%) and superiority for adjunctive ribavirin. Here, we tested the operating characteristics of the stopping guideline for individual randomly assigned groups, planned interim analysis timings and explored power at the final analysis.
RESULTS


A beta (4.5, 0.5) prior for the true cure rate produces less than 0.05 probability of incorrectly stopping an individual randomly assigned group with a true cure rate of more than 90%. Groups with very low cure rates (<60%) are very likely (>0.9 probability) to stop after about 25% of patients are recruited. Groups with moderately low cure rates (80%) are likely to stop (0.7 probability) before overall recruitment finishes. Interim analyses 7, 10, 13 and 18 months after recruitment commences provide good probabilities of stopping inferior individual randomly assigned groups. For an overall true cure rate of 95%, power is more than 90% to confirm non-inferiority in the regimen and strategy comparisons, regardless of the control cure rate, and to detect a 5% absolute difference in the ribavirin comparison.
CONCLUSIONS


The operating characteristics of the stopping guideline are appropriate, and interim analyses can be timed to detect individual randomly assigned groups that are highly likely to have suboptimal performance at various stages. Therefore, our design is suitable for evaluating treatment-shortening or -simplifying strategies.
TRIAL REGISTRATION


ISRCTN registry: ISRCTN61522291. Registered on 4 October 2019.",2020,Groups with very low cure rates (<60%) are very likely (>0.9 probability) to stop after about 25% of patients are recruited.,['Vietnam'],"['shortening strategies or control, and adjunctive ribavirin or no adjunctive ribavirin with shortening strategies', 'ribavirin']",[],"[{'cui': 'C0042658', 'cui_str': 'Vietnam'}]","[{'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}]",[],,0.124331,Groups with very low cure rates (<60%) are very likely (>0.9 probability) to stop after about 25% of patients are recruited.,"[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'McCabe', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, WC1V 6LJ, London, UK. leanne.mccabe@ucl.ac.uk.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'White', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, WC1V 6LJ, London, UK.'}, {'ForeName': 'Nguyen Van Vinh', 'Initials': 'NVV', 'LastName': 'Chau', 'Affiliation': 'Hospital for Tropical Diseases, 764 Vo Van Kiet, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Barnes', 'Affiliation': 'Oxford University, South Parks Road, OX1 3SY, Oxford, UK.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Pett', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, WC1V 6LJ, London, UK.'}, {'ForeName': 'Graham S', 'Initials': 'GS', 'LastName': 'Cooke', 'Affiliation': 'Imperial College London, SW7 2AZ, London, Kensington, UK.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, WC1V 6LJ, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04350-x']
2463,32423509,Consumer perception and behaviour related to low-alcohol wine: do people overcompensate?,"OBJECTIVE


Compared with standard wines, low-alcohol wines may have several social and health benefits. Innovative production processes have led to high-quality light wines. It is, however, unclear how consumers perceive and consume these alcohol-reduced wines. The current study aimed to investigate how people evaluate low-alcohol wine (Sauvignon Blanc) and if the reduction in alcohol and the information that a wine is low in alcohol influences consumption.
DESIGN


Randomised controlled trial (RCT).
SETTING


Participants were invited to a wine tasting and randomised into one of the three conditions: they either tasted a 'new white wine' (12·5 % alcohol content), a 'new low-alcohol white wine' (8·0 % alcohol content) or they tasted the low-alcohol wine but were not aware that the wine was reduced in alcohol (low-alcohol, blinded).
PARTICIPANTS


Ninety participants (42 % male, mean age = 41 (sd 14) years).
RESULTS


Mean comparisons showed similar ratings for the low-alcohol conditions and the standard alcohol condition (mean > 5·6/7). The mean consumed amount across all conditions did not differ (162 (sd 71) ml, (F2,86 = 0·43, P > 0·05)), hence people who tasted the low-alcohol wine consumed approximately 30 % less alcohol. However, participants were willing to pay more for the normal wine compared with the low-alcohol wine, (F2,87 = 3·14, P < 0·05).
CONCLUSIONS


Participants did not alter their drinking behaviour in response to the reduced alcohol content, and the low-alcohol wine was perceived positively. There might be an emerging market potential for wine of reduced alcohol content, but consumers may not be willing to pay the same price as for the standard wine.",2020,"The mean consumed amount across all conditions did not differ (162 (sd 71) ml, (F2,86 = 0·43, P > 0·05)), hence people who tasted the low-alcohol wine consumed approximately 30 % less alcohol.","['Ninety participants (42 % male, mean age = 41', 'Participants were invited to a wine tasting and randomised into one of the three conditions: they either']","[""tasted a 'new white wine' (12·5 % alcohol content), a 'new low-alcohol white wine' (8·0 % alcohol content) or they tasted the low-alcohol wine but were not aware that the wine was reduced in alcohol (low-alcohol, blinded""]",[],"[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0349372', 'cui_str': 'White wine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0452483', 'cui_str': 'Low alcohol wine'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]",[],90.0,0.023985,"The mean consumed amount across all conditions did not differ (162 (sd 71) ml, (F2,86 = 0·43, P > 0·05)), hence people who tasted the low-alcohol wine consumed approximately 30 % less alcohol.","[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Bucher', 'Affiliation': 'School of Environmental and Life Science, Faculty of Science, The University of Newcastle, Callaghan, NSW2308, Australia.'}, {'ForeName': 'Eveline', 'Initials': 'E', 'LastName': 'Frey', 'Affiliation': 'School of Environmental and Life Science, Faculty of Science, The University of Newcastle, Callaghan, NSW2308, Australia.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Wilczynska', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Callaghan, NSW2308, Australia.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Deroover', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Callaghan, NSW2308, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Dohle', 'Affiliation': 'Social Cognition Center Cologne, University of Cologne, 50931Köln, Germany.'}]",Public health nutrition,['10.1017/S1368980019005238']
2464,32423577,"Upper-extremity blood flow restriction: the proximal, distal, and contralateral effects-a randomized controlled trial.","BACKGROUND


Blood flow restriction (BFR) training with low weight is purported to induce similar physiological changes to high-weight regimens with the benefit of less tissue stress. We hypothesized that low-weight training with BFR would produce increased gains in strength and hypertrophy for muscle groups proximal, distal, and contralateral to tourniquet placement compared with low-weight training alone.
METHODS


In this prospective, randomized controlled trial, healthy subjects were randomized into a 6-week low-weight training program either with or without BFR on 1 extremity. Outcome measures included limb circumference and strength. Comparisons were made between the BFR and non-BFR extremities, BFR and control groups, and non-BFR extremity and control groups.
RESULTS


A total of 24 subjects (14 BFR and 10 control subjects) completed the protocol. Significantly greater gains were observed in dynamometric strength both proximal (shoulder scaption [30% greater], flexion [23%], and abduction [22%]) and distal (grip strength [13%]) to the tourniquet in the BFR limb compared with both the non-BFR extremity and the control group (P < .05). Arm and forearm circumferences significantly increased in the BFR limb compared with the non-BFR limb and control group (P = .01). The non-BFR extremity demonstrated greater grip strength than the control group (9%, P < .01). No adverse events were reported.
CONCLUSION


Low-weight BFR training provided a greater increase in strength and hypertrophy in the upper-extremity proximal and distal muscle groups compared with the control group. The non-BFR extremity showed a significant increase in grip strength compared with the control group, indicating a potential systemic effect.",2020,Arm and forearm circumferences significantly increased in the BFR limb compared with the non-BFR limb and control group (P = .01).,"['healthy subjects', '24 subjects (14 BFR and 10 control subjects']","['Low-weight BFR training', 'Blood flow restriction (BFR) training', 'low-weight training program either with or without BFR']","['forearm circumferences', 'gains in strength and hypertrophy', 'strength and hypertrophy', 'grip strength', 'adverse events', 'limb circumference and strength', 'dynamometric strength both proximal (shoulder scaption', 'BFR limb']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",24.0,0.0270852,Arm and forearm circumferences significantly increased in the BFR limb compared with the non-BFR limb and control group (P = .01).,"[{'ForeName': 'Eric N', 'Initials': 'EN', 'LastName': 'Bowman', 'Affiliation': 'Department of Orthopaedics, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: Eric.N.Bowman@vumc.org.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Elshaar', 'Affiliation': 'Rochester Regional Health Orthopaedics, Pittsford, NY, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Milligan', 'Affiliation': 'Elite OrthoSport Physical Therapy, Los Angeles, CA, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Jue', 'Affiliation': 'Select Physical Therapy, Los Angeles, CA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Mohr', 'Affiliation': 'Kerlan Jobe Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Patty Brown Physical Therapy & Associates, El Segundo, CA, USA.'}, {'ForeName': 'Drew M', 'Initials': 'DM', 'LastName': 'Watanabe', 'Affiliation': 'Kerlan Jobe Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Orr', 'Initials': 'O', 'LastName': 'Limpisvasti', 'Affiliation': 'Kerlan Jobe Institute, Los Angeles, CA, USA.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.02.003']
2465,32423694,Association of Deprescribing With Reduction in Mortality and Hospitalization: A Pragmatic Stepped-Wedge Cluster-Randomized Controlled Trial.,"OBJECTIVES


Deprescribing has gained awareness recently, but the clinical benefits observed from randomized trials are limited. The aim of this study was to examine the effectiveness of a pharmacist-led 5-step team-care deprescribing intervention in nursing homes to reduce falls (fall risks and fall rates). Secondary aims include reducing mortality, number of hospitalized residents, pill burden, medication cost, and assessing the deprescribing acceptance rate.
DESIGN


Pragmatic multicenter stepped-wedge cluster randomized controlled trial.
SETTING AND PARTICIPANTS


Residents across 4 nursing homes in Singapore were included if they were aged 65 years and above, and taking 5 or more medications.
METHODS


The intervention involved a 5-step deprescribing intervention, which involved a multidisciplinary team-care medication review with pharmacists, physicians, and nurses (in which pharmacists discussed with other team members the feasibility of deprescribing and implementation using the Beers and STOPP criteria) or to an active waitlist control for the first 3 months.
RESULTS


Two hundred ninety-five residents from 4 nursing homes participated in the study from February 2017 to March 2018. At 6 months, the deprescribing intervention did not reduce falls. Subgroup analysis showed that intervention reduced fall risk scores within the deprescribing-naïve group by 0.18 (P = .04). Intervention was associated with a reduction in mortality [hazard ratio (HR) 0.16, 95% confidence interval 0.07, 0.41; P < .001] and number of hospitalized residents (HR 0.16, 95% CI 0.10, 0.26; P < .001). Pre-post analysis witnessed a reduction in pill burden at the end of the study, and a conservative daily cost saving estimate of US$11.42 (SG$15.65) for the study population. Approximately three-quarters of deprescribing interventions initiated by the pharmacists were accepted by the physicians.
CONCLUSIONS AND IMPLICATIONS


Multidisciplinary medication review-directed deprescribing was associated with reductions in mortality and number of hospitalized residents in nursing homes and should be considered for all nursing home residents.",2020,"Intervention was associated with a reduction in mortality [hazard ratio (HR) 0.16, 95% confidence interval 0.07, 0.41; P < .001] and number of hospitalized residents (HR 0.16, 95% CI 0.10, 0.26; P < .001).","['Residents across 4 nursing homes in Singapore were included if they were aged 65\xa0years and above, and taking 5 or more medications', 'Two hundred ninety-five residents from 4 nursing homes participated in the study from February 2017 to March 2018']","['pharmacist-led 5-step team-care deprescribing intervention', '5-step deprescribing intervention, which involved a multidisciplinary team-care medication review with pharmacists, physicians, and nurses (in which pharmacists discussed with other team members the feasibility of deprescribing and implementation using the Beers and STOPP criteria) or to an active waitlist control for the first 3\xa0months']","['fall risk scores', 'pill burden', 'falls', 'number of hospitalized residents', 'reducing mortality, number of hospitalized residents, pill burden, medication cost, and assessing the deprescribing acceptance rate', 'Mortality and Hospitalization', 'falls (fall risks and fall rates']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0947323', 'cui_str': 'Dispensing medication'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C4042846', 'cui_str': 'STOPP'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.166579,"Intervention was associated with a reduction in mortality [hazard ratio (HR) 0.16, 95% confidence interval 0.07, 0.41; P < .001] and number of hospitalized residents (HR 0.16, 95% CI 0.10, 0.26; P < .001).","[{'ForeName': 'Chong-Han', 'Initials': 'CH', 'LastName': 'Kua', 'Affiliation': 'Continuing and Community Care Department, Tan Tock Seng Hospital, Singapore; School of Pharmacy, Monash University Malaysia, Selangor, Malaysia. Electronic address: chong.kua@monash.edu.'}, {'ForeName': 'Cindy Ying Ying', 'Initials': 'CYY', 'LastName': 'Yeo', 'Affiliation': 'Continuing and Community Care Department, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Poh Ching', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': 'National Healthcare Group Pharmacy, Singapore.'}, {'ForeName': 'Cheryl Wai Teng', 'Initials': 'CWT', 'LastName': 'Char', 'Affiliation': 'National Healthcare Group Pharmacy, Singapore.'}, {'ForeName': 'Cheryl Wei Yan', 'Initials': 'CWY', 'LastName': 'Tan', 'Affiliation': 'National Healthcare Group Pharmacy, Singapore.'}, {'ForeName': 'Vivienne', 'Initials': 'V', 'LastName': 'Mak', 'Affiliation': 'Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Ian Yi-Onn', 'Initials': 'IY', 'LastName': 'Leong', 'Affiliation': 'Continuing and Community Care Department, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Shaun Wen Huey', 'Initials': 'SWH', 'LastName': 'Lee', 'Affiliation': ""School of Pharmacy, Monash University Malaysia, Selangor, Malaysia; School of Pharmacy, Taylor's University Lakeside Campus, Subang Jaya, Selangor, Malaysia.""}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.03.012']
2466,31541242,Effect of Oral Oseltamivir on Virological Outcomes in Low-risk Adults With Influenza: A Randomized Clinical Trial.,"BACKGROUND


Duration of viral shedding is a determinant of infectivity and transmissibility, but few data exist about oseltamivir's ability to alter viral shedding.
METHODS


From January 2012 through October 2017, a randomized, double-blinded multicenter clinical trial was conducted in adults aged 18-64 years at 42 sites in Thailand, the United States, and Argentina. Participants with influenza A or B and without risk factors for complications of influenza were screened for the study. Eligible participants were randomized to receive oseltamivir 75 mg or placebo twice daily for 5 days. The primary endpoint was the percentage of participants with virus detectable by polymerase chain reaction in nasopharyngeal swab at day 3.
RESULTS


Of 716 adults screened for the study, 558 were randomized, and 501 were confirmed to have influenza. Forty-six participants in the pilot study were excluded, and 449 of the 455 participants in the population for the primary analysis had day 3 viral shedding results. Ninety-nine (45.0%) of 220 participants in the oseltamivir arm had virus detected at day 3 compared with 131 (57.2%) of 229 participants in the placebo arm (absolute difference of -12.2% [-21.4%, -3.0%], P =; .010). The median time to alleviation of symptoms was 79.0 hours for the oseltamivir arm and 84.0 hours for the placebo arm (P =; .34) in those with confirmed influenza infection.
CONCLUSIONS


Oseltamivir decreased viral shedding in this low-risk population. However, in the population enrolled in this study, it did not significantly decrease the time to resolution of clinical symptoms.
CLINICAL TRIALS REGISTRATION


NCT01314911.",2020,"Ninety-nine (45.0%) of 220 participants in the oseltamivir arm had virus detected at day 3 compared with 131 (57.2%) of 229 participants in the placebo arm (absolute difference of -12.2% [-21.4%, -3.0%], P =;","['Participants with influenza A or B and without risk factors for complications of influenza were screened for the study', 'Forty-six participants in the pilot study were excluded, and 449 of the 455 participants in the population for the primary analysis had day 3 viral shedding results', 'adults aged 18-64 years at 42 sites in Thailand, the United States, and Argentina', 'Eligible participants', 'Low-risk Adults With Influenza', '716 adults screened for the study, 558 were randomized, and 501 were confirmed to have influenza']","['placebo', 'oseltamivir 75 mg or placebo', 'Oral Oseltamivir']","['percentage of participants with virus detectable by polymerase chain reaction', 'viral shedding', 'time to resolution of clinical symptoms', 'Virological Outcomes', 'median time to alleviation of symptoms']","[{'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1126043', 'cui_str': 'Oseltamivir 75 MG'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",716.0,0.656102,"Ninety-nine (45.0%) of 220 participants in the oseltamivir arm had virus detected at day 3 compared with 131 (57.2%) of 229 participants in the placebo arm (absolute difference of -12.2% [-21.4%, -3.0%], P =;","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Weerawat', 'Initials': 'W', 'LastName': 'Manosuthi', 'Affiliation': 'Bamrasnaradura Infectious Diseases Institute, Department of Disease Control, Nonthaburi, Thailand.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Beeler', 'Affiliation': 'Leidos Biomedical Research, Inc, Frederick, Maryland.'}, {'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Hoppers', 'Affiliation': 'Clinical Research Solutions, Jackson, Tennessee.'}, {'ForeName': 'Kiat', 'Initials': 'K', 'LastName': 'Ruxrungtham', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Chulalongkorn University, and Center for Biostatistics in AIDS Research, Human Immunodeficiency Virus Netherlands Australia Thailand Research Collaboration, Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Beasley', 'Affiliation': 'Health Concepts, Rapid City, South Dakota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ison', 'Affiliation': 'Department of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Anchalee', 'Initials': 'A', 'LastName': 'Avihingsanon', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Chulalongkorn University, and Center for Biostatistics in AIDS Research, Human Immunodeficiency Virus Netherlands Australia Thailand Research Collaboration, Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Marcelo H', 'Initials': 'MH', 'LastName': 'Losso', 'Affiliation': 'Immunocompromised Service, Hospital General De Agudos J. M. Ramos Mejía, Buenos Aires, Argentina.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Langlois', 'Affiliation': 'Social & Scientific Systems, Inc, Silver Spring, Maryland.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Hoopes', 'Affiliation': 'AVR Laboratories LLC, Logan, Utah; and.'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'H Preston', 'Initials': 'HP', 'LastName': 'Holley', 'Affiliation': 'Leidos Biomedical Research, Inc, Frederick, Maryland.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Myers', 'Affiliation': 'Operational Infectious Diseases, Naval Health Research Center, San Diego, California.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hughes', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Davey', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz634']
2467,32423621,Clinical Outcomes of Stereotactic Body Radiotherapy With Immediate Versus Delayed Hormone Therapy in Men With Oligometastatic Recurrence of Prostate Cancer.,"AIMS


Stereotactic body radiotherapy (SBRT) with the delayed option of androgen deprivation therapy (ADT) is the current treatment paradigm in men relapsed with oligometastatic prostate cancer based on the outcome of a phase II randomised controlled study. The immediate (concomitant) use of ADT in this clinical setting potentially augments the efficacy of SBRT by improving systemic disease control. The aim of this study was to compare the clinical outcomes of these two treatment strategies.
MATERIALS AND METHODS


Eighty-eight patients with up to three oligometastases and controlled primary disease who had been treated using SBRT with immediate or delayed ADT were included in this retrospective analysis. Progression-free survival (PFS), widespread failure-free survival (WFFS) and freedom from further interventions (FFFI) were assessed using Kaplan-Meier and Cox proportional hazard regression methods. Toxicity was evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
RESULTS


Thirty-nine patients (44.3%) were treated with SBRT and immediate ADT (continuous ADT, n = 7; intermittent ADT, n = 32) and 49 (55.7%) with SBRT and delayed ADT. The median follow-up was 24 months (interquartile range 13.5-37.0 months). PFS in the immediate and delayed ADT groups were 26 months and 16 months, respectively (P < 0.007). The median WFFS in the immediate ADT group was not reached compared with 21 months in the delayed ADT group (P = 0.025). The 1- and 2-year FFFI in the immediate ADT group were 88% and 64.1%, respectively, significantly higher than those in the delayed ADT group (63.8% and 30.2%, respectively, P < 0.002). Acute toxicities of grade 1-2 occurred in 17.9% of the immediate ADT group and 18.4% of the delayed ADT group (P = 0.96). Only one case of grade 3 late toxicity (pelvic insufficiency) was identified in this study.
CONCLUSIONS


SBRT with concomitant ADT improves PFS, WFFS and FFFI as compared with SBRT with delayed ADT; this finding needs validation in a prospective, randomised study.",2020,The median WFFS in the immediate ADT group was not reached compared with 21 months in the delayed ADT group (P = 0.025).,"['men relapsed with oligometastatic prostate cancer', 'Men With Oligometastatic Recurrence of Prostate Cancer', 'Eighty-eight patients with up to three oligometastases and controlled primary disease who had been treated using SBRT with immediate or delayed ADT were included in this retrospective analysis']","['Stereotactic Body Radiotherapy With Immediate Versus Delayed Hormone Therapy', 'androgen deprivation therapy (ADT', 'SBRT and immediate ADT', 'SBRT with delayed ADT', 'SBRT with concomitant ADT', 'Stereotactic body radiotherapy (SBRT']","['PFS', 'grade 3 late toxicity (pelvic insufficiency', '1- and 2-year FFFI', 'Acute toxicities of grade 1-2', 'median WFFS', 'Toxicity', 'Progression-free survival (PFS), widespread failure-free survival (WFFS) and freedom from further interventions (FFFI', 'PFS, WFFS and FFFI']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",88.0,0.0423596,The median WFFS in the immediate ADT group was not reached compared with 21 months in the delayed ADT group (P = 0.025).,"[{'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Chaw', 'Affiliation': 'Academic Unit of Radiotherapy and Oncology, Royal Marsden NHS Foundation Trust, Chelsea, London, UK. Electronic address: 0109061c@doctors.org.uk.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'deSouza', 'Affiliation': 'Cancer Research UK Imaging Centre, The Institute of Cancer Research and Royal Marsden Hospital, Sutton, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Khoo', 'Affiliation': 'Academic Unit of Radiotherapy and Oncology, Royal Marsden NHS Foundation Trust, Chelsea, London, UK; Radiotherapy and Imaging Division, Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Y E', 'Initials': 'YE', 'LastName': 'Suh', 'Affiliation': 'Academic Unit of Radiotherapy and Oncology, Royal Marsden NHS Foundation Trust, Chelsea, London, UK; Radiotherapy and Imaging Division, Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'van As', 'Affiliation': 'Academic Unit of Radiotherapy and Oncology, Royal Marsden NHS Foundation Trust, Chelsea, London, UK; Radiotherapy and Imaging Division, Institute of Cancer Research, Sutton, London, UK.'}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2020.03.008']
2468,32423584,"Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial.","BACKGROUND


No specific antiviral drug has been proven effective for treatment of patients with severe coronavirus disease 2019 (COVID-19). Remdesivir (GS-5734), a nucleoside analogue prodrug, has inhibitory effects on pathogenic animal and human coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro, and inhibits Middle East respiratory syndrome coronavirus, SARS-CoV-1, and SARS-CoV-2 replication in animal models.
METHODS


We did a randomised, double-blind, placebo-controlled, multicentre trial at ten hospitals in Hubei, China. Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia. Patients were randomly assigned in a 2:1 ratio to intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2-10 in single daily infusions) or the same volume of placebo infusions for 10 days. Patients were permitted concomitant use of lopinavir-ritonavir, interferons, and corticosteroids. The primary endpoint was time to clinical improvement up to day 28, defined as the time (in days) from randomisation to the point of a decline of two levels on a six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first. Primary analysis was done in the intention-to-treat (ITT) population and safety analysis was done in all patients who started their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT04257656.
FINDINGS


Between Feb 6, 2020, and March 12, 2020, 237 patients were enrolled and randomly assigned to a treatment group (158 to remdesivir and 79 to placebo); one patient in the placebo group who withdrew after randomisation was not included in the ITT population. Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23 [95% CI 0·87-1·75]). Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less (hazard ratio 1·52 [0·95-2·43]). Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early.
INTERPRETATION


In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies.
FUNDING


Chinese Academy of Medical Sciences Emergency Project of COVID-19, National Key Research and Development Program of China, the Beijing Science and Technology Project.",2020,Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23,"['Between Feb 6, 2020, and March 12, 2020, 237 patients', 'Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia', 'adults with severe COVID-19', 'patients with severe coronavirus disease 2019 (COVID-19', 'ten hospitals in Hubei, China']","['lopinavir-ritonavir, interferons, and corticosteroids', 'intravenous remdesivir', 'placebo']","['time to clinical improvement', 'six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first', 'Adverse events', 'intention-to-treat (ITT) population and safety analysis', 'adverse events']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",237.0,0.583704,Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23,"[{'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Respiratory Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Guanhua', 'Initials': 'G', 'LastName': 'Du', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ronghui', 'Initials': 'R', 'LastName': 'Du', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shouzhi', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Wuhan Third Hospital, Wuhan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhenshun', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qiaofa', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Wuhan Fourth Hospital, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'The Central Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Guangwei', 'Initials': 'G', 'LastName': 'Luo', 'Affiliation': 'Wuhan First Hospital, Wuhan, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Chengqing', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Mei', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xianzhi', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Wuhan Third Hospital, Wuhan, China.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Wuhan Fourth Hospital, Wuhan, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'The Central Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Aili', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Wuhan First Hospital, Wuhan, China.'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jiuyang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Tsinghua University School of Medicine, Beijing, China.'}, {'ForeName': 'Lianhan', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Lianjun', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'Teddy Clinical Research Laboratory, Shanghai, China.'}, {'ForeName': 'Yushen', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Hangzhou DI'AN Medical Laboratory, Hangzhou, China.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Lancaster University, Lancaster, UK; University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'International Severe Acute Respiratory and Emerging Infection Consortium, University of Oxford, Oxford, UK.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Respiratory Medicine, Capital Medical University, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; Tsinghua University-Peking University Joint Center for Life Sciences, Beijiing, China. Electronic address: caobin_ben@163.com.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; Tsinghua University-Peking University Joint Center for Life Sciences, Beijiing, China; Peking Union Medical College, Beijing, China. Electronic address: wangchen@pumc.edu.cn.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31022-9']
2469,22462436,Development and acceptability of a novel milk-free soybean-maize-sorghum ready-to-use therapeutic food (SMS-RUTF) based on industrial extrusion cooking process.,Peanut milk-based ready-to-use therapeutic food (P-RUTF) primarily used to treat severe acute malnutrition at community setting is expensive. We developed an alternative milk-free soybean-maize-sorghum-based RUTF (SMS-RUTF) using locally grown ingredients that have the potential to support local economy and reduce the cost of RUTF. We describe the production process and results of acceptability of the new product. Acceptability and tolerance of SMS-RUTF was compared with P-RUTF among 45 children aged 4-11 years old based on a cross-over design. Each child consumed 250 g RUTF for 10 days followed by a five-day washout period and a subsequent 10-day period on the second RUTF. The SMS-RUTF was as acceptable as the P-RUTF among normal children aged 4-11 years of age with no associated adverse effects. SMS-RUTF was stable for at least 12 months without detectable microbiological or chemical deterioration. The major challenge encountered in SMS-RUTF development was the difficulty to accurately determine key nutrient composition due to its high oil content. Use of diversified locally available ingredients to produce RUTF is feasible. The SMS-RUTF meets expected standards and is acceptable to children aged 4-11 months old. Effectiveness and cost-effectiveness of SMS-RUTF is required.,2014,Acceptability and tolerance of SMS-RUTF was compared with P-RUTF among 45 children aged 4-11 years old based on a cross-over design.,"['children aged 4-11 months old', '45 children aged 4-11 years old based on a cross-over design']","['Peanut milk-based ready-to-use therapeutic food (P-RUTF', 'novel milk-free soybean-maize-sorghum ready-to-use therapeutic food (SMS-RUTF', 'SMS-RUTF', 'alternative milk-free soybean-maize-sorghum-based RUTF (SMS-RUTF']","['Acceptability and tolerance', 'Effectiveness and cost-effectiveness', 'SMS-RUTF']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242817', 'cui_str': 'Cross-Over Design'}]","[{'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0037733', 'cui_str': 'Soy Beans'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0331570', 'cui_str': 'Sorghum'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",45.0,0.0167609,Acceptability and tolerance of SMS-RUTF was compared with P-RUTF among 45 children aged 4-11 years old based on a cross-over design.,"[{'ForeName': 'Victor O', 'Initials': 'VO', 'LastName': 'Owino', 'Affiliation': 'Valid Nutrition, Nairobi, Kenya Valid International, Lusaka, Zambia Valid International, Oxford, UK.'}, {'ForeName': 'Abel H', 'Initials': 'AH', 'LastName': 'Irena', 'Affiliation': ''}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Dibari', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2012.00400.x']
2470,32423730,CPAP Effects on Oxygen Delivery in One-Lung Ventilation During Minimally Invasive Surgical Ablation for Atrial Fibrillation in The Supine Position.,"OBJECTIVE


In minimally invasive surgical ablation for atrial fibrillation during video-assisted thoracoscopy surgery, one-lung ventilation (OLV) with a double- lumen tube is commonly employed. In contrast with the majority of thoracic procedures, the patient lies supine; thus, the protective effect of gravity is lost and intrapulmonary shunt remains high. To decrease intrapulmonary shunt and to increase oxygenation, many strategies are utilized: high inspiratory fraction of oxygen (F I O 2 ), positive end-expiratory pressure on the ventilated lung, and continuous positive airway pressure (CPAP) on the deflated lung.
DESIGN


The authors performed a prospective, single- center, randomized study to evaluate the effect of additional CPAP in the nonventilated lung on oxygen delivery during surgical ablation for atrial fibrillation via video-assisted thoracoscopy in the supine position.
SETTING


University hospital Centro Cardiologico Monzino IRCCS, Milano, Italy.
PARTICIPANTS


Twenty-two patients scheduled for minimally invasive surgical ablation for atrial fibrillation.
INTERVENTIONS


The patients underwent pressure-controlled ventilation, adjusting inspiratory pressure to obtain a tidal volume of 7 mL/kg while keeping F I O 2  constantly 1.0, a respiratory rate to maintain arterial partial pressure of carbon dioxide (PaCO 2 ) between 35 and 40 mmHg, and positive end-expiratory pressure of 5 cmH 2 O. During OLV, inspiratory pressure was reduced to obtain a tidal volume of 5 mL/kg, maintaining F I O 2  of 1.0, a respiratory rate to maintain PaCO 2  between 35 and 40 mmHg with capnothorax of 10 cmH 2 O. The patients were then randomized into the CPAP group (CPAP 10 cmH 2 0 on deflated lung) and NO CPAP group. Inotropic agents (dopamine or dobutamine) were used if cardiac index fell below 1.5 L/min/m 2 .
MEASUREMENTS AND MAIN RESULTS


Twenty-two patients were enrolled, randomized, and completed the study. Median age was 62 years. The difference in arterial partial pressure of oxygen between the 2 groups was shy of significance, p = 0.16. Cardiac index progressively increased during OLV until the end of the procedure in both groups (p < 0.01) and was maintained above 1.5 mL/min/m 2  during the whole study time. Arterial oxygen content remained stable during the entire procedure in both groups (p = 0.27). Oxygen delivery index (DO 2 I) increased significantly during the procedure (p < 0.01); nevertheless, the difference in DO 2 I between the CPAP and NO CPAP group was nonsignificant (p = 0.61). Intrapulmonary shunt (Q s /Q t ) increased during OLV (p < 0.01 for the time effect) and remained high until total lung ventilation was reintroduced. No difference in Q s /Q t  was observed between the CPAP and NO CPAP groups (p = 0.98). Similarly, mean pulmonary artery pressure increased significantly during OLV and remained high at the end of the procedure in both groups (time effect p < 0.01).
CONCLUSIONS


During OLV for atrial fibrillation surgical ablation in the supine position, CPAP on the deflated lung seemed to be ineffective to reduce Q s /Q t  or to increase arterial partial pressure of oxygen and DO 2 I, provided cardiac output was maintained above 1.5 L/min/m 2 .",2020,"The difference in arterial partial pressure of oxygen between the 2 groups was shy of significance, p = 0.16.","['One-Lung Ventilation', 'Twenty-two patients scheduled for minimally invasive surgical ablation for atrial fibrillation', 'University hospital Centro Cardiologico Monzino IRCCS, Milano, Italy', 'Twenty-two patients', 'Median age was 62 years']","['additional CPAP', 'CPAP group (CPAP 10 cmH 2 0 on deflated lung) and NO CPAP', 'video-assisted thoracoscopy surgery, one-lung ventilation (OLV', 'pressure-controlled ventilation, adjusting inspiratory pressure to obtain a tidal volume of 7 mL/kg while keeping F I O 2  constantly 1.0, a respiratory rate to maintain arterial partial pressure of carbon dioxide (PaCO 2 ) between 35 and 40 mmHg, and positive end-expiratory pressure of 5 cmH 2 O', 'CPAP', 'Inotropic agents (dopamine or dobutamine', 'minimally invasive surgical ablation']","['Arterial oxygen content', 'Cardiac index', 'Oxygen delivery index', 'Q s /Q', 'mean pulmonary artery pressure', 'arterial partial pressure of oxygen and DO 2 I, provided cardiac output', 'Oxygen Delivery', 'arterial partial pressure of oxygen']","[{'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C2923055', 'cui_str': 'Video assisted thoracoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0304509', 'cui_str': 'Inotropic agent'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0012963', 'cui_str': 'Dobutamine'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0523806', 'cui_str': 'Oxygen measurement'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",22.0,0.0544509,"The difference in arterial partial pressure of oxygen between the 2 groups was shy of significance, p = 0.16.","[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': ""L'Acqua"", 'Affiliation': 'Department of Anesthesia and Intensive Care, Centro Cardiologico Monzino IRCCS, Milano, Italy. Electronic address: Camilla.lacqua@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Meli', 'Affiliation': ""Department of Medical Surgical Pathophysiology and Organ Transplantation, Universita' Degli Studi Di Milano Statale, Milano, Italy.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Rondello', 'Affiliation': 'Department of Anesthesia and Intensive Care, Centro Cardiologico Monzino IRCCS, Milano, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Polvani', 'Affiliation': 'Department of Cardiac Surgery, Centro Cardiologico Monzino IRCCS, Milano, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Salvi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Centro Cardiologico Monzino IRCCS, Milano, Italy.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.03.064']
2471,22458649,A one-year school-based diet/exercise intervention improves non-traditional disease biomarkers in Mexican-American children.,"School-based interventions are an effective way to treat childhood obesity. The purpose of the present study was to biologically validate an established school-based intervention designed to reduce standardised body mass index (zBMI) over a period of 12 months. This intervention focused on a subset of Mexican-American children who were participating in a larger clinical weight loss study. Plasma samples were analysed from self-identified Mexican-American children (12-14 years) who were randomised to either a school-based intervention (IN, n = 152) or self-help control (CN, n = 69). Treatment was 4 days week⁻¹ of exercise (45 min day⁻¹) and 1 day week⁻¹ of nutritional counselling for 6 months. Fasting (>8 h) blood samples were collected at baseline, 6 months (end of active intervention) and 12 months (6 months after the end of the active intervention). Plasma resistin, adiponectin and leptin concentration were measured using a multiplex assay. Separate linear mixed models and a P < 0.05 were used to test for significance. Significant group × time interactions were found for resistin (P < 0.0001), adiponectin (P = 0.001) and leptin (P = 0.013). For resistin, IN was 12% lower at 6 months than CN. Adiponectin concentration in IN was greater at 6 months (26%) and 12 months (8%) than CN. Leptin concentration was 22% lower for IN at 12 months than CN. We have previously reported that our school-based intervention reduced zBMI and now reported alterations in biologically relevant disease biomarkers. Some of the observed changes were only present at the end of the active intervention (resistin), while others persisted until 12 months (leptin and adiponectin). These changes underscore the effectiveness of our school-based intervention at not only improving zBMI but also at reducing disease risk.",2013,"Significant group × time interactions were found for resistin (P < 0.0001), adiponectin (P = 0.001) and leptin (P = 0.013).","['Mexican-American children', 'Mexican-American children (12-14 years', 'Mexican-American children who were participating in a larger clinical weight loss study']","['exercise intervention', 'school-based intervention (IN, n = 152) or self-help control (CN']","['Plasma resistin, adiponectin and leptin concentration', 'Fasting (>8 h) blood samples', 'Leptin concentration', 'adiponectin', 'leptin', 'Adiponectin concentration', 'standardised body mass index (zBMI']","[{'cui': 'C0025884', 'cui_str': 'Chicanas'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0219229,"Significant group × time interactions were found for resistin (P < 0.0001), adiponectin (P = 0.001) and leptin (P = 0.013).","[{'ForeName': 'Brian Keith', 'Initials': 'BK', 'LastName': 'McFarlin', 'Affiliation': 'Department of Health and Human Performance, University of Houston, Houston, Texas, USA Department of Pediatrics, Baylor College of Medicine, Houston, Texas, USA Department of Behavioral Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Johnston', 'Affiliation': ''}, {'ForeName': 'Katie C', 'Initials': 'KC', 'LastName': 'Carpenter', 'Affiliation': ''}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Davidson', 'Affiliation': ''}, {'ForeName': 'Jennette L', 'Initials': 'JL', 'LastName': 'Moreno', 'Affiliation': ''}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Strohacker', 'Affiliation': ''}, {'ForeName': 'Whitney L', 'Initials': 'WL', 'LastName': 'Breslin', 'Affiliation': ''}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Foreyt', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2011.00398.x']
2472,32423706,The prognostic value of voiding chart data in therapy-resistant enuresis.,"INTRODUCTION


The case history is the primary tool when investigating the enuretic child. To further determine whether nocturnal polyuria or detrusor overactivity is present, a full voiding chart, is the method of choice. However, there is no robust evidence that daytime voiding chart data actually do predict nocturnal detrusor function.
AIM


The aim of this study was to assess the predictive value of anamnestic data and the voiding chart in the treatment of children with therapy-resistant enuresis.
PATIENTS AND METHODS


The patients all suffered from enuresis resistant to first-line therapy. None of the children had daytime incontinence. In accordance with international recommendations, the children were first treated with anticholinergics. If the therapeutic effect was not satisfactory dosage was adjusted and desmopressin was added. If sufficient treatment effect was not achieved, antidepressant therapy was tried next, combined with desmopressin if needed. Since this was an evaluation of clinical practice, not a randomized trial, treatment success was graded according to family satisfaction, not the actual frequency of wet nights. Thus, only children who reported that they were completely dry were regarded as full responders and those who stated that there was a substantial and useful reduction of wet nights were labeled intermediate responders.
RESULTS


In total, 154 patients were included. Few and inconsistent differences were found between the groups responding or not responding to the various treatment regimens, and this was true both for anamnestic and voiding chart data (see Table). The only statistically significant findings were that responders to antidepressant therapy were older (p = 0.013) than non-responders, and patients who benefited from addition of desmopressin had a higher micturition frequency than those who did not (p = 0.027). The children who needed desmopressin as part of combination treatment to become dry did not have significantly higher nocturnal urine production than those who had no such benefit (p = 0.619). Neither the presence of urgency nor a history of previous daytime incontinence was significantly more common in children responding to anticholinergics (p = 0.375 and 0.072, respectively).
DISCUSSION


No clear and consistent differences in either anamnestic factors or voiding chart data were found between the patients responding or not responding to the various treatment regimens. Not even urgency could predict anticholinergic efficacy. Somewhat surprisingly, no association between nocturnal polyuria and desmopressin benefit was found.
CONCLUSION


In this study no prognostic value was found in anamnestic or voiding chart data in children with therapy resistant enuresis.",2020,No clear and consistent differences in either anamnestic factors or voiding chart data were found between the patients responding or not responding to the various treatment regimens.,"['children with therapy resistant enuresis', '154 patients were included', 'children with therapy-resistant enuresis']","['anticholinergics', 'desmopressin']","['daytime incontinence', 'nocturnal polyuria and desmopressin benefit', 'presence of urgency nor a history of previous daytime incontinence', 'micturition frequency', 'nocturnal urine production', 'anticholinergic efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0014394', 'cui_str': 'Enuresis'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0848232', 'cui_str': 'Nocturnal polyuria'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",154.0,0.0265485,No clear and consistent differences in either anamnestic factors or voiding chart data were found between the patients responding or not responding to the various treatment regimens.,"[{'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Lundmark', 'Affiliation': 'Dept. of Women´s and Children´s Health, Uppsala University, Akademiska Barnsjukhuset, SE-751 85 Uppsala, Sweden. Electronic address: elisabet.lundmark@kbh.uu.se.'}, {'ForeName': 'Tryggve', 'Initials': 'T', 'LastName': 'Neve Us', 'Affiliation': 'Dept. of Women´s and Children´s Health, Uppsala University, Akademiska Barnsjukhuset, SE-751 85 Uppsala, Sweden.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.02.020']
2473,32423734,"Right Ventricular Systolic Assessment by Transesophageal Versus Transthoracic Echocardiography: Displacement, Velocity, and Myocardial Deformation.","OBJECTIVE


First, to compare tricuspid annular displacement and velocity in transthoracic and transesophageal echocardiography (TTE, TEE) using conventional angle-dependent technologies. Second, to evaluate both alternative TEE views as well as an alternative technology (speckle tracking) for overcoming proposed differences in TTE and TEE.
DESIGN


Prospective, comparative, cross-over study with a randomized order of image acquisition.
SETTING


University hospital.
PARTICIPANTS


Adults undergoing cardiac surgery.
INTERVENTIONS


Postinduction standardized image acquisition and analysis in TTE and TEE by 2 echocardiographers.
MEASUREMENTS AND MAIN RESULTS


The authors measured tricuspid annular plane systolic excursion (TAPSE) by M-mode and velocity by tissue Doppler (S') in the apical 4-chamber TTE view and midesophageal 4-chamber TEE view (AP4C, ME4C). They then examined (1) the same measurements in alternative TEE views with proposed better ultrasound angulation; and (2) speckle tracking-based endpoints (TAPSE by speckle tracking, strain, and strain rate). Data were available in 24 of 25 patients. Conventional TAPSE by M-mode and velocity by tissue Doppler (TDI) were underestimated in the ME4C compared with the AP4C reference (mean ± standard deviation: TAPSE: 13.1 ± 3.8 mm v 17.3 ± 4.0 mm; S': 6.7 ± 2.1 cm/s v 9.1 ± 2.2 cm/s; both p < 0.001). Neither a modified deep transgastric view (TAPSE 14.5 ± 4.7 mm, p = 0.017; S' 6.8 ± 1.8 cm/s, p < 0.001) nor a transgastric right ventricular inflow view (TAPSE 12.3 ± 4.0 mm, p = 0.001; S' 6.0 ± 1.3 cm/s, p < 0.001) was similar to the AP4C. Speckle tracking TAPSE was unbiased but with high variability (mean bias = -0.3 mm, 95% limits of agreement = -9.1 to 8.4); strain and strain rate were higher in TEE than for TTE (-17.7 ± 3.6 v -12.6 ± 2.1, p < 0.001; -1.0 ± 0.2/s v -0.7 ± 0.1/s, p < 0.001).
CONCLUSIONS


Right ventricular displacement, velocity, and myocardial deformation measured by TEE versus TTE are different. Neither alternative transesophageal echocardiography views nor speckle tracking-based deformation is promising; TAPSE by speckle tracking is unbiased but imprecise.",2020,"Neither a modified deep transgastric view (TAPSE 14.5 ± 4.7 mm, p = 0.017; S' 6.8 ± 1.8 cm/s, p < 0.001) nor a transgastric right ventricular inflow view (TAPSE 12.3 ± 4.0 mm, p = 0.001; S' 6.0 ± 1.3 cm/s, p < 0.001) was similar to the AP4C. Speckle tracking TAPSE was unbiased but with high variability (mean bias = -0.3 mm, 95% limits of agreement = -9.1 to 8.4); strain and strain rate were higher in TEE than for TTE (-17.7 ± 3.6 v -12.6 ± 2.1, p < 0.001; -1.0 ± 0.2/s v -0.7 ± 0.1/s, p < 0.001).
","['University hospital', 'Adults undergoing cardiac surgery']","['transthoracic and transesophageal echocardiography (TTE, TEE']","[""tricuspid annular plane systolic excursion (TAPSE) by M-mode and velocity by tissue Doppler (S') in the apical 4-chamber TTE view and midesophageal 4-chamber TEE view (AP4C, ME4C"", 'Right ventricular displacement, velocity, and myocardial deformation', 'Conventional TAPSE by M-mode and velocity by tissue Doppler (TDI', 'strain and strain rate', 'transgastric right ventricular inflow view']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0443327', 'cui_str': 'Tricuspid'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]","[{'cui': 'C3888926', 'cui_str': 'Tricuspid annular plane systolic excursion'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0631478', 'cui_str': ""adenosine 5' P(1)-tetraphosphate-P(4)-5'''-cytidine""}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0442355', 'cui_str': 'Transgastric'}]",,0.044055,"Neither a modified deep transgastric view (TAPSE 14.5 ± 4.7 mm, p = 0.017; S' 6.8 ± 1.8 cm/s, p < 0.001) nor a transgastric right ventricular inflow view (TAPSE 12.3 ± 4.0 mm, p = 0.001; S' 6.0 ± 1.3 cm/s, p < 0.001) was similar to the AP4C. Speckle tracking TAPSE was unbiased but with high variability (mean bias = -0.3 mm, 95% limits of agreement = -9.1 to 8.4); strain and strain rate were higher in TEE than for TTE (-17.7 ± 3.6 v -12.6 ± 2.1, p < 0.001; -1.0 ± 0.2/s v -0.7 ± 0.1/s, p < 0.001).
","[{'ForeName': 'Eckhard', 'Initials': 'E', 'LastName': 'Mauermann', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ghent University Hospital, Ghent, Belgium; Department of Anesthesiology, University Hospital Basel, Basel, Switzerland. Electronic address: Eckhard.Mauermann@usb.ch.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vandenheuvel', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'François', 'Affiliation': 'Department of Cardiac Surgery, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Bouchez', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wouters', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Ghent University Hospital, Ghent, Belgium.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.03.009']
2474,31825772,Cost-effectiveness of TLC-sucrose octasulfate versus control dressings in the treatment of diabetic foot ulcers.,"OBJECTIVE


Diabetes is one of the most widespread diseases in Germany. Common complications are diabetic foot ulcers (DFU), which are associated with a cost-intensive treatment and serious adverse events, such as infections, amputations. This cost-effectiveness analysis compares two treatment options for patients with DFU: a TLC-NOSF dressing versus a neutral dressing, assessed through a European double-blind randomised controlled trial (RCT), Explorer.
METHODS


The evaluation of the clinical outcomes was associated to direct costs (costs for dressings, nursing time, hospitalisation etc.) of both dressings, from the perspective of the statutory health insurance in Germany. Due to the long mean healing time of a DFU, the observation period was extended from 20 to 100 weeks in a Markov model.
RESULTS


After 20 weeks, and with complete closure as a primary endpoint, the model revealed direct treatment costs for DFU of €2,864.21 when treated with a TLC-NOSF dressing compared with €2,958.69 with the neutral control dressing (cost-effectiveness: €6,017.25 versus €9,928.49). In the Markov model (100 weeks) the costs for the TLC-NOSF dressing were €5,882.87 compared with €8,449.39 with the neutral dressing (cost-effectiveness: €6,277.58 versus €10,375.56). The robustness of results was underlined by several sensitivity analyses for varying assumptions. The frequency of weekly dressing changes had the most significant influence in terms of parameter uncertainty.
CONCLUSION


Overall, the treatment of DFU with a TLC-NOSF dressing is supported from a health economic perspective, because both the treatment costs and the cost-effectiveness were superior compared with the neutral wound dressing.",2019,"In the Markov model (100 weeks) the costs for the TLC-NOSF dressing were €5,882.87 compared with €8,449.39 with the neutral dressing (cost-effectiveness: €6,277.58 versus €10,375.56).","['patients with DFU', 'diabetic foot ulcers']","['TLC-sucrose octasulfate versus control dressings', 'TLC-NOSF dressing']","['direct costs (costs for dressings, nursing time, hospitalisation etc.) of both dressings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}, {'cui': 'C0075479', 'cui_str': 'sucrose octasulfate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.0411819,"In the Markov model (100 weeks) the costs for the TLC-NOSF dressing were €5,882.87 compared with €8,449.39 with the neutral dressing (cost-effectiveness: €6,277.58 versus €10,375.56).","[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Lobmann', 'Affiliation': 'Professor; Krankenhaus Bad Cannstatt (kbc) / Klinikum Stuttgart.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Professor; Universitätsklinikum Hamburg-Eppendorf (UKE).'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Lawall', 'Affiliation': 'Professor; Gemeinschaftspraxis (joint practice) Prof. Dr. med Curt Diehm/Dr. med Holger Lawall, Ettlingen, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Tigges', 'Affiliation': 'Wundzentrum Hamburg.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Potempa', 'Affiliation': 'Institute for Empirical Health Economics, Burscheid, Germany.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Thiem', 'Affiliation': 'Institute for Empirical Health Economics, Burscheid, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Fietz', 'Affiliation': 'Institute for Empirical Health Economics, Burscheid, Germany.'}, {'ForeName': 'Reinhard Pt', 'Initials': 'RP', 'LastName': 'Rychlik', 'Affiliation': 'Professor.'}]",Journal of wound care,['10.12968/jowc.2019.28.12.808']
2475,32281393,Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial.,"BACKGROUND


Current understanding of the impact of cardiac implantable electronic device (CIED) infection is based on retrospective analyses from medical records or administrative claims data. The WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) offers an opportunity to evaluate the clinical and economic impacts of CIED infection from the hospital, payer, and patient perspectives in the US healthcare system.
METHODS


This was a prespecified, as-treated analysis evaluating outcomes related to major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs. Payer costs were assigned using medicare fee for service national payments, while medicare advantage, hospital, and patient costs were derived from similar hospital admissions in administrative datasets.
RESULTS


Major CIED infection was associated with increased all-cause mortality (12-month risk-adjusted hazard ratio, 3.41 [95% CI, 1.81-6.41];  P <0.001), an effect that sustained beyond 12 months (hazard ratio through all follow-up, 2.30 [95% CI, 1.29-4.07];  P =0.004). Quality of life was reduced ( P =0.004) and did not normalize for 6 months. Disruptions in CIED therapy were experienced in 36% of infections for a median duration of 184 days. Mean costs were $55 547±$45 802 for the hospital, $26 867±$14 893, for medicare fee for service and $57 978±$29 431 for Medicare Advantage (mean hospital margin of -$30 828±$39 757 for medicare fee for service and -$6055±$45 033 for medicare advantage). Mean out-of-pocket costs for patients were $2156±$1999 for medicare fee for service, and $1658±$1250 for medicare advantage.
CONCLUSIONS


This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world datasets. CIED infections severely impact mortality, quality of life, healthcare utilization, and cost in the US healthcare system. Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT02277990.",2020,Quality of life was reduced ( P =0.004) and did not normalize for 6 months.,['978±$29\u2009431 for Medicare Advantage'],"['Registration: URL', 'Cardiac Implantable Electronic Device Infection', 'cardiac implantable electronic device (CIED) infection']","['mortality, quality of life, healthcare utilization, and cost', 'Mean costs', 'Payer costs', 'major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs', 'Quality of life', 'cause mortality']","[{'cui': 'C2713369', 'cui_str': 'Medicare advantage coverage'}]","[{'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C1504335', 'cui_str': 'Device therapy'}]",,0.150794,Quality of life was reduced ( P =0.004) and did not normalize for 6 months.,"[{'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Wilkoff', 'Affiliation': 'Department of Cardiovascular Medicine and Heart and Vascular Institute, Cleveland Clinic, OH (B.L.W., K.G.T.).'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Boriani', 'Affiliation': 'Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy (G.B.).'}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Cardiology, Section of Electrophysiology, Valley Health System, Ridgewood, NJ (S.M.).'}, {'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle (J.E.P.).'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kennergren', 'Affiliation': 'The Sahlgrenska Academy, University of Göteborg, Sweden (C.K.).'}, {'ForeName': 'G Ralph', 'Initials': 'GR', 'LastName': 'Corey', 'Affiliation': 'Department of Medicine, Duke Clinical Research Institute, Durham, NC (G.R.C.).'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Love', 'Affiliation': 'Maine Medical Partners, Maine Medical Center, Portland (J.C.L.).'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Augostini', 'Affiliation': 'Department of Internal Medicine, Ohio State University, Columbus (R.A.).'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Faerestrand', 'Affiliation': 'Department of Heart Disease, University of Bergen and Haukeland University Hospital, Norway (S.F.).'}, {'ForeName': 'Sherman S', 'Initials': 'SS', 'LastName': 'Wiggins', 'Affiliation': 'ARK-LA-TEX Cardiology, Christus Highland Hospital, Shreveport, LA (S.S.W.).'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Population Health Research Institute, McMaster University, ON, Canada (J.S.H.).'}, {'ForeName': 'Reece', 'Initials': 'R', 'LastName': 'Holbrook', 'Affiliation': 'Cardiac Rhythm & Heart Failure (CRHF) Therapy Development and Clinical Research, Medtronic, Mounds View, MN (R.H., J.D.L., D.R.L., S.W.).'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Lande', 'Affiliation': 'Cardiac Rhythm & Heart Failure (CRHF) Therapy Development and Clinical Research, Medtronic, Mounds View, MN (R.H., J.D.L., D.R.L., S.W.).'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Lexcen', 'Affiliation': 'Cardiac Rhythm & Heart Failure (CRHF) Therapy Development and Clinical Research, Medtronic, Mounds View, MN (R.H., J.D.L., D.R.L., S.W.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Willey', 'Affiliation': 'Cardiac Rhythm & Heart Failure (CRHF) Therapy Development and Clinical Research, Medtronic, Mounds View, MN (R.H., J.D.L., D.R.L., S.W.).'}, {'ForeName': 'Khaldoun G', 'Initials': 'KG', 'LastName': 'Tarakji', 'Affiliation': 'Department of Cardiovascular Medicine and Heart and Vascular Institute, Cleveland Clinic, OH (B.L.W., K.G.T.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.008280']
2476,31812327,"Pilot randomised controlled trial of a brief coping-focused intervention for hearing voices blended with smartphone-based ecological momentary assessment and intervention (SAVVy): Feasibility, acceptability and preliminary clinical outcomes.","BACKGROUND


Voice-hearing experiences can be distressing and impairing, and existing psychological treatments show modest effectiveness. Ecological momentary assessment and intervention (EMA/I) are two promising approaches which may be used as digital tools to support and enhance existing psychological therapies. The aim of this study was to investigate the potential clinical utility of smartphone-based EMA/I in a blended, coping focused therapy for voice-hearing experiences.
METHOD


This pilot RCT focused on feasibility, acceptability and preliminary estimations of efficacy. Thirty-four participants with persisting and distressing voices were randomised to receive the four-session intervention along-side treatment-as-usual (TAU) or TAU-only.
RESULTS


Findings supported the feasibility and acceptability of the approach, with good engagement and satisfaction rates, and clinical outcomes showed the intervention holds promise for improving coping, overall severity of voices and to some degree their negative impact.
CONCLUSION


This is the first examination of the use of EMA/I in a blended therapy for psychotic experiences, with findings suggesting these technologies show promise as clinical tools.",2020,"Thirty-four participants with persisting and distressing voices were randomised to receive the four-session intervention along-side treatment-as-usual (TAU) or TAU-only.
","['Thirty-four participants with persisting and distressing voices', 'voice-hearing experiences']","['brief coping-focused intervention for hearing voices blended with smartphone-based ecological momentary assessment and intervention (SAVVy', 'Ecological momentary assessment and intervention', 'EMA', 'smartphone-based EMA', 'four-session intervention along-side treatment-as-usual (TAU) or TAU-only']",[],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0423539', 'cui_str': 'Finding of ability to hear voice'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0268596', 'cui_str': 'Glutaric aciduria, type 2'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],34.0,0.0528688,"Thirty-four participants with persisting and distressing voices were randomised to receive the four-session intervention along-side treatment-as-usual (TAU) or TAU-only.
","[{'ForeName': 'Imogen H', 'Initials': 'IH', 'LastName': 'Bell', 'Affiliation': 'Centre for Mental Health, Swinburne University of Technology, Australia. Electronic address: imogen.bell@orygen.org.au.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Rossell', 'Affiliation': ""Centre for Mental Health, Swinburne University of Technology, Australia; Department of Psychiatry, St. Vincent's Hospital, Australia.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Farhall', 'Affiliation': 'Department of Psychology and Counselling, La Trobe University, Australia; NorthWestern Mental Health, Melbourne Health, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hayward', 'Affiliation': 'Sussex Partnership NHS Foundation Trust, UK; School of Psychology, University of Sussex, UK.'}, {'ForeName': 'Michelle H', 'Initials': 'MH', 'LastName': 'Lim', 'Affiliation': 'Centre for Mental Health, Swinburne University of Technology, Australia.'}, {'ForeName': 'Sarah F', 'Initials': 'SF', 'LastName': 'Fielding-Smith', 'Affiliation': 'Sussex Partnership NHS Foundation Trust, UK; School of Psychology, University of Sussex, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Thomas', 'Affiliation': 'Centre for Mental Health, Swinburne University of Technology, Australia. Electronic address: neilthomas@swin.edu.au.'}]",Schizophrenia research,['10.1016/j.schres.2019.10.026']
2477,32422066,Effect of Acupuncture for Postprandial Distress Syndrome.,"BACKGROUND


Postprandial distress syndrome (PDS) is the most common subtype of functional dyspepsia. Acupuncture is commonly used to treat PDS, but its effect is uncertain because of the poor quality of prior studies.
OBJECTIVE


To assess the efficacy of acupuncture versus sham acupuncture in patients with PDS.
DESIGN


Multicenter, 2-group, randomized clinical trial. (ISRCTN registry number: ISRCTN12511434).
SETTING


5 tertiary hospitals in China.
PARTICIPANTS


Chinese patients aged 18 to 65 years meeting Rome IV criteria for PDS.
INTERVENTION


12 sessions of acupuncture or sham acupuncture over 4 weeks.
MEASUREMENTS


The 2 primary outcomes were the response rate based on overall treatment effect and the elimination rate of all 3 cardinal symptoms: postprandial fullness, upper abdominal bloating, and early satiation after 4 weeks of treatment. Participants were followed until week 16.
RESULTS


Among the 278 randomly assigned participants, 228 (82%) completed outcome measurements at week 16. The estimated response rate from generalized linear mixed models at week 4 was 83.0% in the acupuncture group versus 51.6% in the sham acupuncture group (difference, 31.4 percentage points [95% CI, 20.3 to 42.5 percentage points];  P  < 0.001). The estimated elimination rate of all 3 cardinal symptoms was 27.8% in the acupuncture group versus 17.3% in the sham acupuncture group (difference, 10.5 percentage points [CI, 0.08 to 20.9 percentage points];  P  = 0.034). The efficacy of acupuncture was maintained during the 12-week posttreatment follow-up. There were no serious adverse events.
LIMITATION


Lack of objective outcomes and daily measurement, high dropout rate, and inability to blind acupuncturists.
CONCLUSION


Among patients with PDS, acupuncture resulted in increased response rate and elimination rate of all 3 cardinal symptoms compared with sham acupuncture, with sustained efficacy over 12 weeks in patients who received thrice-weekly acupuncture for 4 weeks.
PRIMARY FUNDING SOURCE


Beijing Municipal Science and Technology Commission.",2020,"The estimated response rate from generalized linear mixed models at week 4 was 83.0% in the acupuncture group versus 51.6% in the sham acupuncture group (difference, 31.4 percentage points [95% CI, 20.3 to 42.5 percentage points];  ","['5 tertiary hospitals in China', 'Chinese patients aged 18 to 65 years meeting Rome IV criteria for PDS', 'patients with PDS', 'Postprandial Distress Syndrome', '278 randomly assigned participants, 228 (82%) completed outcome measurements at week 16']","['acupuncture', 'acupuncture versus sham acupuncture', 'acupuncture or sham acupuncture', 'Acupuncture', 'sham acupuncture']","['response rate based on overall treatment effect and the elimination rate of all 3 cardinal symptoms: postprandial fullness, upper abdominal bloating, and early satiation', 'elimination rate of all 3 cardinal symptoms', 'response rate and elimination rate']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0326926', 'cui_str': 'Cardinalis cardinalis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}]",278.0,0.617612,"The estimated response rate from generalized linear mixed models at week 4 was 83.0% in the acupuncture group versus 51.6% in the sham acupuncture group (difference, 31.4 percentage points [95% CI, 20.3 to 42.5 percentage points];  ","[{'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Shi-Yan', 'Initials': 'SY', 'LastName': 'Yan', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China (S.Y.).'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China (Y.W., J.T.).'}, {'ForeName': 'Jing-Jie', 'Initials': 'JJ', 'LastName': 'Zhao', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, China (J.Z., Y.D.).'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China (Y.W., J.T.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (J.W.).'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Shi', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China (H.H.).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Huguosi Hospital of Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China (W.Z.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, China (J.Z., Y.D.).'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, and Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China (C.L.).'}]",Annals of internal medicine,['10.7326/M19-2880']
2478,32421841,"An open-label, randomized, single-dose, two-period, two-treatment crossover bioavailability study comparing 5 mg/0.5 mL of intramuscular naloxone hydrochloride to 2 mg/0.4 mL intramuscular naloxone hydrochloride autoinjector in healthy subjects.","Naloxone is an opioid antagonist used for the acute treatment of opioid overdoses. There has been a dramatic increase of deaths due to synthetic opioids such as fentanyl, some requiring multiple doses of naloxone for reversal of opioid tox-icity. Fentanyl appears to differ from other opiates as having a very rapid onset and transport in and out of the central nervous system (CNS). Fentanyl is therefore widely distributed in the CNS. Furthermore, a high range of systemic levels of fentanyl have been observed in overdose victims. Taken together, we believe it is very likely that higher doses of naloxone are needed to combat this new era of overdoses. We examined the bioavailability of an investigational 5 mg intramuscular naloxone in a prefilled syringe (PFS) compared to 2 mg intramuscular naloxone in an autoinjector (AI) at the current approved dose in a crossover design which included 14 healthy subjects. Overall, both doses were well tol-erated with no adverse events noted during the trial. The pharmacokinetic results showed that a higher dose of intra-muscular naloxone hydrochloride increases C max , AUC, and t 1/2;  however, T max  was similar for both treatments. Statistical analysis indicated that there were statistical differences between the test and reference treatments for C max,  AUCs, and t 1/2  with ratios of test to reference for C max  of 337.1 percent (CI: 263.3 percent, 431.5 percent), AUC 0-t  of 277.5 percent (CI: 260.4 percent, 295.7 percent), AUC 0-inf  of 273.4 percent (CI: 255.6 percent, 292.4 percent), and t 1/2  of 110.5 percent (CI: 95.5, 127.9). These results are consistent with the study rationale that indicated higher doses of intramuscular naloxone hy-drochloride would result in higher C max  and AUCs. These PK characteristics may be desirable for reversing opioid toxicity caused by the higher, more potent synthetic opioids.",2020,"Statistical analysis indicated that there were statistical differences between the test and reference treatments for C max,  AUCs, and t 1/2  with ratios of test to reference for C max  of 337.1 percent (CI: 263.3 percent, 431.5 percent), AUC 0-t  of 277.5 percent (CI: 260.4 percent, 295.7 percent), AUC 0-inf  of 273.4 percent","['14 healthy subjects', 'healthy subjects']","['naloxone hydrochloride autoinjector', 'intramuscular naloxone hydrochloride', 'Fentanyl', 'naloxone hydrochloride', 'naloxone', 'Naloxone']","['opioid toxicity', 'C max , AUC, and t 1/2;  however, T max']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0700549', 'cui_str': 'Naloxone hydrochloride'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}]","[{'cui': 'C0412850', 'cui_str': 'Poisoning by opiate analgesic drug'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0580272', 'cui_str': '1/2'}]",14.0,0.0445083,"Statistical analysis indicated that there were statistical differences between the test and reference treatments for C max,  AUCs, and t 1/2  with ratios of test to reference for C max  of 337.1 percent (CI: 263.3 percent, 431.5 percent), AUC 0-t  of 277.5 percent (CI: 260.4 percent, 295.7 percent), AUC 0-inf  of 273.4 percent","[{'ForeName': 'Ronald B', 'Initials': 'RB', 'LastName': 'Moss', 'Affiliation': 'Adamis Pharmaceuticals Corp., San Diego, California.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Carleton', 'Affiliation': 'Adamis Pharmaceuticals Corp., San Diego, California.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Lollo', 'Affiliation': 'Adamis Pharmaceuticals Corp., San Diego, California.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Carlo', 'Affiliation': 'Adamis Pharmaceuticals Corp., San Diego, California.'}]",Journal of opioid management,['10.5055/jom.2020.0569']
2479,22377591,Lifestyle factors associated with serum N-3 fatty acid levels in breast cancer patients.,"Long chain n3 fatty acids appear to have beneficial effects in several domains of health relevant to breast cancer survivors. This study evaluated inter-individual differences in serum levels of n3 fatty acids in 40 breast cancer patients who were participating in a pilot study for prevention of weight gain. Significant predictors of baseline n3 fatty acid levels in serum were dietary intakes of n3 fatty acids, BMI, serum levels of carotenoids and TV hours watched/day, accounting for 43% of the variance. Counseling for prevention of weight gain also tended to increase n3 fatty acid blood levels over time during chemotherapy.",2012,"n3 fatty acid levels in serum were dietary intakes of n3 fatty acids, BMI, serum levels of carotenoids and TV hours watched/day, accounting for 43% of the variance.","['breast cancer patients', '40 breast cancer patients who were participating in a pilot study for prevention of weight gain']","['Long chain n3 fatty acids', 'n3 fatty acids']","['serum N-3 fatty acid levels', 'n3 fatty acid blood levels', 'n3 fatty acid levels']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005768'}]",,0.0376762,"n3 fatty acid levels in serum were dietary intakes of n3 fatty acids, BMI, serum levels of carotenoids and TV hours watched/day, accounting for 43% of the variance.","[{'ForeName': 'Zora', 'Initials': 'Z', 'LastName': 'Djuric', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI 48109, USA. zoralong@umich.edu'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Ellsworth', 'Affiliation': ''}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': ''}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2012.02.003']
2480,32422097,"In irritable bowel syndrome, fecal microbiota transplantation improved symptoms at 3 months.","SOURCE CITATION


El-Salhy M, Hatlebakk JG, Gilja OH, Bråthen Kristoffersen A, Hausken T.  Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study.  Gut. 2020;69:859-67. 31852769.",2020,"SOURCE CITATION


El-Salhy M, Hatlebakk JG, Gilja OH, Bråthen Kristoffersen A,",['patients with irritable bowel syndrome'],"['faecal microbiota transplantation', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0812731,"SOURCE CITATION


El-Salhy M, Hatlebakk JG, Gilja OH, Bråthen Kristoffersen A,","[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Talley', 'Affiliation': 'University of Newcastle, Newcastle, New South Wales, Australia (N.J.T., M.I.).'}, {'ForeName': 'Mudar', 'Initials': 'M', 'LastName': 'Irani', 'Affiliation': 'University of Newcastle, Newcastle, New South Wales, Australia (N.J.T., M.I.).'}]",Annals of internal medicine,['10.7326/ACPJ202005190-052']
2481,32421737,Predictors of change of health workers' knowledge and skills after the Helping Mothers Survive Bleeding after Birth (HMS BAB) in-facility training in Tanzania.,"BACKGROUND


Our study aimed to assess the effect of Helping Mothers Survive Bleeding after Birth on knowledge and skills of health workers and whether such effect varies by health workers characteristics.
METHODS


Nested in a cluster-randomised trial to assess the effect of the training on health outcomes, we assessed changes in knowledge and simulated skills in 61 facilities. The assessments were done i) before, ii) immediately-after training session and iii) at 10-month follow-up for subset of health-workers of implementation facilities as defined by the trial. We used a self-administered questionnaire and Objective Structures Clinical Examinations to assess three skill sets: Active Management of Third Stage of Labour, removal of retained placenta and management of severe postpartum haemorrhage. We computed summary statistics and used the paired t-test to assess change of knowledge and skills immediately post-training and at 10-month follow-up. Linear regression was done to assess association of scores and health worker characteristics.
RESULTS


Of the 636 health workers included, 606 (96.7%) and 591 (91.4%) completed the knowledge and skills assessments, respectively. Majority of the participants (68%) were nurse-midwives. Knowledge scores increased by 15 percentage-points from 77.5% to 93% (95% CI 14.3, 16.3, p-value <0.000), and skills scores by 47 percentage-points (95% CI 46.5, 49.2, p-value <0.000) from 37.5% to 83%. There was a 4.0% decline of skills at 10-month follow-up. The decline was higher in auxiliary staff (-11.8%) and least in nurse-midwives (-2.1%) p-value <0.001. Health workers who assisted less than 5 deliveries in the last month, those who never attended postpartum haemorrhage in-service training and profession experience >8 years were associated with lower mean skill change immediately post-training.
CONCLUSION


Our study supports the potential of the Helping Mothers Survive Bleeding after Birth training to increase knowledge and skills of postpartum haemorrhage among all professional groups. Auxiliary staff benefited most from the training but also showed higher skill decline at 10-month. Our study highlights the importance to disaggregate knowledge and skills by health workers characteristics.",2020,"Knowledge scores increased by 15 percentage-points from 77.5% to 93% (95% CI 14.3, 16.3, p-value <0.000), and skills scores by 47 percentage-points (95% CI 46.5, 49.2, p-value <0.000) from 37.5% to 83%.","['61 facilities', 'Health workers who assisted less than 5 deliveries in the last month, those who never attended postpartum haemorrhage in-service training and profession experience >8 years', 'Of the 636 health workers', 'Mothers Survive Bleeding after Birth (HMS BAB) in-facility training in Tanzania']",[],"['knowledge and skills of postpartum haemorrhage', 'Knowledge scores', 'auxiliary staff', 'skills scores', 'skill decline']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557286', 'cui_str': 'No formal education'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0262500', 'cui_str': 'Routine health maintenance'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]",,0.0861455,"Knowledge scores increased by 15 percentage-points from 77.5% to 93% (95% CI 14.3, 16.3, p-value <0.000), and skills scores by 47 percentage-points (95% CI 46.5, 49.2, p-value <0.000) from 37.5% to 83%.","[{'ForeName': 'Fadhlun', 'Initials': 'F', 'LastName': 'Alwy Al-Beity', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Andrea Barnabas', 'Initials': 'AB', 'LastName': 'Pembe', 'Affiliation': 'Department of Obstetrics and Gynaecology, Muhimbili University of Health and Allied Sciences, Dar es salaam, Tanzania.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Marrone', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Baker', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Hanson', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0232983']
2482,32421854,"A Phase 2, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of VT-1161 oral tablets in the treatment of patients with distal and lateral subungual onychomycosis of the toenail.","BACKGROUND


Onychomycosis is a fungal disease that affects the fingernails and toenails and is predominantly caused by dermatophytes. VT-1161 is a novel inhibitor of fungal CYP51 through the inhibition of the lanosterol demethylase, and has demonstrated potent activity against T. rubrum and T. mentagrophytes.
OBJECTIVE


To evaluate the safety and efficacy of four dosing regimens of orally-administered VT-1161 compared with placebo in patients with moderate to severe distal and lateral subungual onychomycosis of the toenail.
METHOD


A Phase 2, randomized, double-blind, placebo-controlled, multicenter study (ClinicalTrials.gov Identifier NCT02267356). Patients aged 18-70 years (n=259) who had ≥25% to ≤75% mycotic involvement were randomized to 5 treatment groups, and received 300 mg VT-1161 as a two-week daily dose, followed by a once-weekly dose for either 10 or 22 weeks, or 600 mg VT-1161 as a two-week daily dose, followed by a once-weekly dose for either 10 or 22 weeks. All treatment groups were followed by a non-treatment period of 36 weeks. A matching placebo arm was included.
RESULTS


In the Intent-to-treat population, complete cure rates were 0% in the placebo group and ranged from 32% to 42% in VT-1161 treatment groups (p<0.001 vs. placebo), at Week 48. VT-1161 was well tolerated with no evidence of an adverse effect on liver function or QT intervals.
CONCLUSIONS


VT-1161 treatment led to high nail clearance rates and a favourable safety profile. VT-1161 exhibits characteristics that appear promising for the treatment of this chronic and difficult to treat condition and warrants further evaluation in larger studies.",2020,"VT-1161 is a novel inhibitor of fungal CYP51 through the inhibition of the lanosterol demethylase, and has demonstrated potent activity against T. rubrum and T. mentagrophytes.
","['patients with moderate to severe distal and lateral subungual onychomycosis of the toenail', 'Patients aged 18-70 years (n=259) who had ≥25% to ≤75% mycotic involvement', 'patients with distal and lateral subungual onychomycosis of the toenail']","['VT-1161 oral tablets', 'placebo']","['nail clearance rates', 'efficacy and safety', 'safety and efficacy', 'complete cure rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1274513', 'cui_str': 'Distal and lateral subungual onychomycosis'}, {'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C4043593', 'cui_str': 'VT-1161'}, {'cui': 'C0993159', 'cui_str': 'Oral tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.272912,"VT-1161 is a novel inhibitor of fungal CYP51 through the inhibition of the lanosterol demethylase, and has demonstrated potent activity against T. rubrum and T. mentagrophytes.
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Elewski', 'Affiliation': 'Department of Dermatology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'Viamet Pharmaceuticals Inc, Durham, North Carolina, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Degenhardt', 'Affiliation': 'Viamet Pharmaceuticals Inc, Durham, North Carolina, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Curelop', 'Affiliation': 'Viamet Pharmaceuticals Inc, Durham, North Carolina, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pollack', 'Affiliation': 'Endeavor Clinical Trials, San Antonio, Texas, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schotzinger', 'Affiliation': 'Viamet Pharmaceuticals Inc, Durham, North Carolina, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tavakkol', 'Affiliation': 'Viamet Pharmaceuticals Inc, Durham, North Carolina, USA.'}]",The British journal of dermatology,['10.1111/bjd.19224']
2483,32421909,Contrasting Personal Characteristics and Psychosocial Correlates of Exercise and Eating Behavior Changes in Women Successful vs. Unsuccessful with Weight Loss and Maintenance.,"BACKGROUND


There is great variability in individuals' responses to behavioral weight-loss treatments. Beyond attaining meaningful weight loss in the initial several weeks, little is known of the characteristics of participants successful vs. unsuccessful with short- and long-term weight loss.
METHODS


Separate samples of women with obesity enrolled in cognitive-behavioral weight-loss treatments were assessed over 6 months (Study 1: successful weight-loss group, n = 83; unsuccessful group, n = 158), and over 24 months (Study 2: sustained initially lost weight, n = 25; regained weight, n = 19), on personal characteristics and theory-driven psychosocial variables.
RESULTS


In Study 1, significantly older age and greater eating self-regulation at baseline were found in the successful group. Significantly greater improvements in exercise- and eating-related self-regulation, mood, exercise- and eating-related self-efficacy, physical self-concept, and body satisfaction were found in the successful group. In Study 2, the sustainer group had significantly more favorable changes over 2 years in exercise- and eating-related self-regulation, and mood. During Months 6-24, the psychosocial correlates of both exercise and eating behaviors regressed, with more pronounced reversions in the regainer group.
CONCLUSION


Increasing the magnitude of treatment-associated improvement in each of the tested theory-based psychosocial factors is warranted to increase probabilities for success with attaining and maintaining meaningful weight loss.",2020,"Significantly greater improvements in exercise- and eating-related self-regulation, mood, exercise- and eating-related self-efficacy, physical self-concept, and body satisfaction were found in the successful group.","['Separate samples of women with obesity enrolled in cognitive-behavioral weight-loss treatments were assessed over 6\xa0months (Study 1: successful weight-loss group, n\xa0=\xa083; unsuccessful group, n\xa0=\xa0158), and over 24\xa0months (Study 2: sustained initially lost weight, n\xa0=\xa025; regained weight, n\xa0=\xa019), on personal characteristics and theory-driven psychosocial variables']",[],"['exercise- and eating-related self-regulation, mood, exercise- and eating-related self-efficacy, physical self-concept, and body satisfaction', 'eating self-regulation']","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0336377,"Significantly greater improvements in exercise- and eating-related self-regulation, mood, exercise- and eating-related self-efficacy, physical self-concept, and body satisfaction were found in the successful group.","[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Annesi', 'Affiliation': 'YMCA of Metro Atlanta, Atlanta, GA, USA.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12203']
2484,32422098,"In adults with AF who regularly drink alcohol, a 6-month abstinence intervention reduced AF recurrence and burden.","SOURCE CITATION


Voskoboinik A, Kalman JM, De Silva A, et al.  Alcohol abstinence in drinkers with atrial fibrillation.  N Engl J Med. 2020;382:20-8. 31893513.",2020,"SOURCE CITATION


Voskoboinik A, Kalman JM, De Silva A, et al.  ",['drinkers with atrial fibrillation'],['Alcohol abstinence'],['AF recurrence and burden'],"[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0678274', 'cui_str': 'Alcohol Abstinence'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0204255,"SOURCE CITATION


Voskoboinik A, Kalman JM, De Silva A, et al.  ","[{'ForeName': 'Meghana', 'Initials': 'M', 'LastName': 'Gore', 'Affiliation': 'Memorial Hermann Hospital, Katy, Texas, USA (M.G.).'}, {'ForeName': 'Vijaiganesh', 'Initials': 'V', 'LastName': 'Nagarajan', 'Affiliation': 'University of Texas, Houston, Texas, USA (V.N.).'}]",Annals of internal medicine,['10.7326/ACPJ202005190-053']
2485,32422099,"In acute HF, intensive and sustained vasodilation did not reduce a composite of death or HF readmission at 180 days.","SOURCE CITATION


Kozhuharov N, Goudev A, Flores D, et al.  Effect of a strategy of comprehensive vasodilation vs usual care on mortality and heart failure rehospitalization among patients with acute heart failure: the GALACTIC randomized clinical trial.  JAMA. 2019;322:2292-302. 31846016.",2020,Effect of a strategy of comprehensive vasodilation vs usual care on mortality and heart failure rehospitalization among patients with acute heart failure: the GALACTIC randomized clinical trial.  ,['patients with acute heart failure'],['comprehensive vasodilation vs usual care'],"['mortality and heart failure rehospitalization', 'composite of death or HF readmission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}]","[{'cui': 'C0042401', 'cui_str': 'Vasodilatation'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}]",,0.0940406,Effect of a strategy of comprehensive vasodilation vs usual care on mortality and heart failure rehospitalization among patients with acute heart failure: the GALACTIC randomized clinical trial.  ,"[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Santulli', 'Affiliation': ""Albert Einstein College of Medicine-Montefiore University Hospital, New York, New York, USA, University of Naples 'Federico II' and ITME, Naples, Italy (G.S.).""}]",Annals of internal medicine,['10.7326/ACPJ202005190-054']
2486,32422100,"In unprotected left main CAD, revascularization with PCI and DES increased risk for MACCE vs CABG at 5 years.","SOURCE CITATION


Holm NR, Mäkikallio T, Lindsay MM, et al.  Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial.  Lancet. 2019;395:191-9. 31879028.",2020,"Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial.  ",['unprotected left main stenosis'],['Percutaneous coronary angioplasty versus coronary artery bypass grafting'],[],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0002997', 'cui_str': 'Angioplasty, Coronary Balloon'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]",[],,0.0876096,"Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial.  ","[{'ForeName': 'Saraschandra', 'Initials': 'S', 'LastName': 'Vallabhajosyula', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA (S.V., M.R.B.).'}, {'ForeName': 'Malcolm R', 'Initials': 'MR', 'LastName': 'Bell', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA (S.V., M.R.B.).'}]",Annals of internal medicine,['10.7326/ACPJ202005190-055']
2487,32421814,"Isolating the role of time in bed restriction in the treatment of insomnia: a randomised, controlled, dismantling trial comparing sleep restriction therapy with time in bed regularisation.","STUDY OBJECTIVES


Sleep restriction therapy (SRT) is one of the most effective treatments for insomnia. Restriction of time in bed (TIB) is assumed to be the central mechanism through which SRT improves sleep consolidation and reduces insomnia symptoms. This hypothesis has never been directly tested. We designed a randomised, controlled, dismantling trial in order to isolate the role of TIB restriction in driving both clinical and polysomnographic sleep outcomes.
METHODS


Participants aged 25-55 who met DSM-5 diagnostic criteria for insomnia disorder were block-randomised (1:1) to four weeks of SRT or time in bed regularisation (TBR), a treatment that involves prescription of a regular but not reduced time in bed. The primary outcome was assessed with the insomnia severity index (ISI) at baseline, 4-, and 12-weeks post-randomisation. Secondary outcomes included sleep continuity (assessed via polysomnography, actigraphy, and diary) and quality of life. We performed intention-to treat analyses using linear mixed models.
RESULTS


Fifty-six participants (39 females, mean age=40.78±9.08) were assigned to SRT (n=27) or TBR (n=29). Daily monitoring of sleep via diaries and actigraphy confirmed large group differences in TIB (d range = 1.63-1.98). At 4-weeks post-randomisation the adjusted mean difference for the ISI was -4.49 (d=-1.40) and -4.35 at 12-weeks (d=-1.36), indicating that the SRT group reported reduced insomnia severity relative to TBR. Robust treatment effects in favour of SRT were also found for objective and self-reported sleep continuity variables (d range=0.40-0.92) and sleep-related quality of life (d=1.29).
CONCLUSIONS


For the first time we demonstrate that time in bed restriction is superior to the regularisation of time in bed on its own. Our results underscore the centrality of the restriction component in reducing insomnia symptoms and consolidating sleep.",2020,"Robust treatment effects in favour of SRT were also found for objective and self-reported sleep continuity variables (d range=0.40-0.92) and sleep-related quality of life (d=1.29).
","['Fifty-six participants (39 females, mean age=40.78±9.08) were assigned to SRT (n=27) or TBR (n=29', 'Participants aged 25-55 who met DSM-5 diagnostic criteria for insomnia disorder', 'insomnia']","['Sleep restriction therapy (SRT', 'SRT or time in bed regularisation (TBR', 'SRT']","['sleep continuity (assessed via polysomnography, actigraphy, and diary) and quality of life', 'Restriction of time in bed (TIB', 'insomnia severity index (ISI', 'sleep-related quality of life', 'insomnia symptoms and consolidating sleep', 'insomnia severity relative to TBR', 'objective and self-reported sleep continuity variables']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",56.0,0.102752,"Robust treatment effects in favour of SRT were also found for objective and self-reported sleep continuity variables (d range=0.40-0.92) and sleep-related quality of life (d=1.29).
","[{'ForeName': 'Leonie Franziska', 'Initials': 'LF', 'LastName': 'Maurer', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, UK.'}, {'ForeName': 'Colin Alexander', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, UK.'}, {'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'Omlin', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, UK.'}, {'ForeName': 'Matthew James', 'Initials': 'MJ', 'LastName': 'Reid', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sharman', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, UK.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Gavriloff', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Simon David', 'Initials': 'SD', 'LastName': 'Kyle', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, UK.'}]",Sleep,['10.1093/sleep/zsaa096']
2488,32422113,Comparison of Subthreshold 532 nm Diode Micropulse Laser with Conventional Laser Photocoagulation in the Treatment of Non-Centre Involved Clinically Significant Diabetic Macular Edema.,"BACKGROUND


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


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


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


SML was more effective than CLP in reducing CMT and improving BCVA in patients with non-centre involved CSME. Therefore, it seems that SML can be a good substitute for CLP in DME treatment if confirmed in future studies.",2020,"Moreover, significant improvement was detected 6 months after SML in G1 regarding BCVA compared to values before laser treatment (p = 0.001).
","['60 eyes of patients diagnosed with non-centre involved CSME', 'patients with non-centre involved CSME']","['SML photocoagulation', 'conventional laser photocoagulation (CLP', 'SML', 'CLP', '532 nm (green) diode subthreshold micropulse laser (SML', 'Subthreshold 532 nm Diode Micropulse Laser with Conventional Laser Photocoagulation']","['Central macular thickness (CMT) and best corrected visual acuity (BCVA', 'CMT and improving BCVA', 'CMT']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0730284', 'cui_str': 'Clinically significant macular edema'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",,0.0244198,"Moreover, significant improvement was detected 6 months after SML in G1 regarding BCVA compared to values before laser treatment (p = 0.001).
","[{'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Bougatsou', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece.'}, {'ForeName': 'Eirini-Kanella', 'Initials': 'EK', 'LastName': 'Panagiotopoulou', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece. eipanagi@med.duth.gr.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gkika', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece.'}, {'ForeName': 'Doukas', 'Initials': 'D', 'LastName': 'Dardabounis', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece.'}, {'ForeName': 'Aristeidis', 'Initials': 'A', 'LastName': 'Konstantinidis', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Sideroudi', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Perente', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Labiris', 'Affiliation': 'Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, Alexandroupolis, Greece.'}]",Acta medica (Hradec Kralove),['10.14712/18059694.2020.12']
2489,32422214,Clinical peri-implant health and biological bone marker levels in tobacco users treated with photodynamic therapy.,"BACKGROUND


What impact does tobacco smoking have on the photodynamic therapy (PDT) outcomes is still unknown. The aim of the present 6-month follow-up clinical trial was to evaluate the clinical, radiographic, and biological bone markers after provision of PDT in cigarette, e-cigarette, and never-smokers with peri-implantitis (PI).
MATERIALS AND METHODS


Twenty-five healthy patients with PI were divided into three groups: Group I: cigarette smokers; Group II: e-cigarettes users; Group III: never-smokers. Full-mouth mechanical debridement with adjunctive methylene blue-mediated PDT was performed. Clinical recordings included peri-implant plaque index (Pi), bleeding on probing (BOP) and probing depth (PD). Peri-implant sulcular fluid was collected for the assessment of biological bone biomarkers including receptor activator of nuclear factor-ligand (RANK-L) and osteoprotegrin (OPG). All assessments were performed at baseline, 3 months, and 6 months. P-value of <0.05 was considered significant.
RESULTS


BOP in Group II and III significantly reduced at 3 months (p < 0.05). Group I showed significant reduction only at 6 months (p < 0.05). Mean PD showed no statistically significant difference between the groups at any time-point. Inter-group comparison showed Group III demonstrating statistically significantly reduced mean RANK-L levels at both 3 and 6 months (p < 0.05). A slight increase in the OPG levels were observed at 3 months and followed by a slight decrease at 6 months for all the study groups when compared with baseline values, however, these values did not show statistical significance (p > 0.05).
CONCLUSION


Adjunctive PDT helped in reducing the clinical peri-implant inflammation. However, no significant change was observed for biological bone biomarkers among tobacco smokers.",2020,"A slight increase in the OPG levels were observed at 3 months and followed by a slight decrease at 6 months for all the study groups when compared with baseline values, however, these values did not show statistical significance (p > 0.05).
","['tobacco users treated with', 'Twenty-five healthy patients with PI', 'cigarette, e-cigarette, and never-smokers with peri-implantitis (PI']","['photodynamic therapy', 'cigarette smokers; Group II: e-cigarettes users; Group III: never-smokers', 'adjunctive methylene blue-mediated PDT']","['mean RANK-L levels', 'OPG levels', 'clinical peri-implant inflammation', 'peri-implant plaque index (Pi), bleeding on probing (BOP) and probing depth (PD', 'Mean PD', 'biological bone biomarkers']","[{'cui': 'C3853727', 'cui_str': 'Tobacco user'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4505216', 'cui_str': 'Electronic cigarette user'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4543210', 'cui_str': 'Receptor activator'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",25.0,0.0122046,"A slight increase in the OPG levels were observed at 3 months and followed by a slight decrease at 6 months for all the study groups when compared with baseline values, however, these values did not show statistical significance (p > 0.05).
","[{'ForeName': 'Modhi', 'Initials': 'M', 'LastName': 'AlDeeb', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Alresayes', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'A Mokeem', 'Affiliation': 'Department of Periodontics and Community Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Aasem M', 'Initials': 'AM', 'LastName': 'Alhenaki', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'AlHelal', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia; Research Chair for Biological Research in Dental Health, College of Dentistry, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Vohra', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Abduljabbar', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia; Research Chair for Biological Research in Dental Health, College of Dentistry, Riyadh 11545, Saudi Arabia. Electronic address: academicksa1@gmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101821']
2490,32422244,"Implementation of Basic life support training for school children: Online education for potential instructors? Results of a cluster randomised, controlled, non-inferiority trial.","AIM OF THE STUDY


Comprehensive training of the population in Basic Life Support (BLS) increases the chance of survival in cardiac arrest. To implement BLS trainings at schools a high number of instructors will be needed. This non-inferiority study investigated, if online education is effective to prepare instructors to teach BLS compared to face-to-face education.
METHODS


A cluster randomised, controlled, single blinded study was performed in 2018 in Hamburg, Germany. A mixed group of potential instructors were allocated alternately to either the intervention or control group and participated in a four-hour instructor training. The instructor training of the control group was realised by trained educators. The intervention group participated in a self-regulated online training with hands-on training supported by peers. Instructors provided BLS training for high school students. The primary endpoint was a mean score in the BLS skills assessment of the students. The secondary endpoint was teaching effectiveness of the instructors.
RESULTS


BLS assessments of 808 students of 46 classes, who were taught by 74 instructors could be analysed. The students trained by interventional instructors achieved 0.14 points less (95%-CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48). The non-inferiority could not be confirmed. The teaching performance in the intervention group was better in some aspects compared to the control group.
CONCLUSION


Integrating all results of this study, online education may be an effective alternative to prepare potential BLS instructors. Using free online courses, motivated persons can independently acquire necessary skills to become instructors and autonomously realise low cost BLS trainings at schools.",2020,The students trained by interventional instructors achieved 0.14 points less (95%-CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48).,"['808 students of 46 classes, who were taught by 74 instructors could be analysed', '2018 in Hamburg, Germany', 'high school students', 'school children']","['Basic life support training', 'BLS training', 'self-regulated online training with hands-on training supported by peers', 'intervention or control group and participated in a four-hour instructor training']","['mean score in the BLS skills assessment of the students', 'teaching effectiveness of the instructors']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",,0.042077,The students trained by interventional instructors achieved 0.14 points less (95%-CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48).,"[{'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Napp', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Kosan', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hoffend', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Haege', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Breitfeld', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Doehn', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kubitz', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Beck', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}]",Resuscitation,['10.1016/j.resuscitation.2020.04.041']
2491,32423894,Efficacy of recombinant thrombomodulin for poor prognostic cases of acute exacerbation in idiopathic interstitial pneumonia: secondary analysis of the SETUP trial.,"BACKGROUND


Acute exacerbation (AE) in idiopathic pulmonary fibrosis and other idiopathic interstitial pneumonias (IIPs) are poor prognostic events although they are usually treated with conventional therapy with corticosteroids and immunosuppressants. Previously, we demonstrated the safety and efficacy of recombinant human soluble thrombomodulin (rhTM) for AE-IIP in the SETUP trial. Here, we aimed to clarify the efficacy of rhTM for poor-prognosis cases of AE-IIP.
METHODS


In this study, we included 85 patients, in whom fibrin degradation product (FDP)/d-dimer was evaluated at AE, from the 100 patients in the SETUP trial. The AE-IIP patients in the rhTM arm (n=39) were diagnosed using the Japanese criteria from 2014 to 2016 and treated with intravenous rhTM for 6 days in addition to the conventional therapy. The AE-IIP patients in the control arm (n=46) were treated with the conventional therapy without rhTM between 2011 and 2013. The subjects were classified into higher and lower FDP/d-dimer groups based on the Japanese Association for Acute Medicine Disseminated Intravascular Coagulation scoring system. A multivariate Cox proportional hazard regression analysis with stepwise selection was performed to reveal the prognostic factors of AE-IIP.
RESULTS


We developed a prognostic scoring system using two significant prognostic factors, higher FDP/d-dimer at AE and prednisolone therapy before AE, with 3 and 2 points assigned for each parameter, respectively. The prognostic scores ranged from 0 to 5. Survival of AE-IIP patients with a prognostic score=0 was significantly better than that of patients with score ≥2. Survival was improved with the rhTM therapy (p<0.05) in the poor prognostic cases (score ≥2), but not in the good prognostic cases (score=0).
CONCLUSIONS


Treatment with rhTM might improve survival in AE-IIP cases with poor prognoses. Trial registration number UMIN000014969, date: 28 August 2014.",2020,"Survival was improved with the rhTM therapy (p<0.05) in the poor prognostic cases (score ≥2), but not in the good prognostic cases (score=0).
","['AE-IIP patients in the rhTM arm (n=39) were diagnosed using the Japanese criteria from 2014 to 2016 and treated with', '85 patients, in whom fibrin degradation product (FDP)/d-dimer was evaluated at AE, from the 100 patients in the SETUP trial', 'idiopathic interstitial pneumonia']","['intravenous rhTM', 'recombinant human soluble thrombomodulin (rhTM', 'rhTM therapy', 'conventional therapy without rhTM', 'recombinant thrombomodulin', 'rhTM']","['Survival', 'safety and efficacy', 'survival']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2350236', 'cui_str': 'Idiopathic interstitial pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0163275', 'cui_str': 'Fibrin degradation product'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085786', 'cui_str': 'Diffuse interstitial pulmonary fibrosis'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",85.0,0.0411982,"Survival was improved with the rhTM therapy (p<0.05) in the poor prognostic cases (score ≥2), but not in the good prognostic cases (score=0).
","[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Arai', 'Affiliation': 'Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kida', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, Suita City, Osaka, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Ogata', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hiroshima University, Hiroshima City, Hiroshima, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Marumo', 'Affiliation': 'Respiratory Disease Center, Tazuke Kofukai Medical Research Institute, Kitano Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Respiratory Medicine, Osaka Prefectural Hospital Organization Osaka Habikino Medical Center, Habikino City, Osaka, Japan.'}, {'ForeName': 'Iwao', 'Initials': 'I', 'LastName': 'Gohma', 'Affiliation': 'Department of Respiratory Medicine, Sakai City Medical Center, Sakai City, Osaka, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Osaka Minami Medical Center, Kawachinagano City, Osaka, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka City, Osaka, Japan.'}, {'ForeName': 'Chikatoshi', 'Initials': 'C', 'LastName': 'Sugimoto', 'Affiliation': 'Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan.'}, {'ForeName': 'Kazunobu', 'Initials': 'K', 'LastName': 'Tachibana', 'Affiliation': 'Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Akira', 'Affiliation': 'Department of Radiology, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan giichiyi@me.com.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000558']
2492,22342928,"A multicenter, randomized controlled trial comparing a single intra-articular injection of Gel-200, a new cross-linked formulation of hyaluronic acid, to phosphate buffered saline for treatment of osteoarthritis of the knee.","OBJECTIVE


To compare the safety and efficacy of a single intra-articular (IA) injection of a new cross-linked hyaluronic acid product, Gel-200, with phosphate buffered saline (PBS, control) in a multi-center randomized controlled trial in patients with symptomatic osteoarthritis (OA) of the knee.
DESIGN


Patients were randomized 2:1 to receive a single injection of Gel-200 or PBS, after joint aspiration. The primary measure of effectiveness was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscores by 100-mm Visual Analog Scale (VAS); secondary outcomes included: total WOMAC, physical function, and stiffness subscores; patient and physician global assessments of disease activity, Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responders, as well as safety of Gel-200.
RESULTS


Of 379 patients randomized, safety was evaluated in 377 and efficacy in 375 (98.9% randomized) in the intent-to-treat population. Effectiveness of Gel-200 by WOMAC pain subscores was statistically significant at week 13 (P=0.037). Mean improvements from baseline in WOMAC pain subscores consistently favored Gel-200 at each visit. Effectiveness of Gel-200 treatment was statistically significant over weeks 3-13 by WOMAC total score, physical function, and physician global evaluations (P<0.05). The number of ""strict"" OMERACT-OARSI responders was statistically significant from weeks 6 to 13 (P=0.022). Adverse events were not significantly different between treatment groups, including serious adverse events considered related to study treatment.
CONCLUSIONS


This trial demonstrated that a single injection of Gel-200 was well tolerated and relieved pain associated with symptomatic OA of the knee over 13 weeks.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NTC 00449696.",2012,"Effectiveness of Gel-200 treatment was statistically significant over weeks 3-13 by WOMAC total score, physical function, and physician global evaluations (P<0.05).","['osteoarthritis of the knee', '379 patients randomized', 'patients with symptomatic osteoarthritis (OA) of the knee']","['single intra-articular (IA) injection of a new cross-linked hyaluronic acid product, Gel-200, with phosphate buffered saline (PBS, control', 'Gel-200', 'Gel-200 or PBS', 'hyaluronic acid, to phosphate buffered saline']","['effectiveness was Western Ontario and McMaster Universities Osteoarthritis Index', 'WOMAC total score, physical function, and physician global evaluations', 'WOMAC pain subscores', 'Adverse events', 'WOMAC) pain subscores by 100-mm Visual Analog Scale (VAS); secondary outcomes included: total WOMAC, physical function, and stiffness subscores; patient and physician global assessments of disease activity, Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responders, as well as safety of Gel-200', 'tolerated and relieved pain', 'safety and efficacy', 'number of ""strict"" OMERACT-OARSI responders']","[{'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021488', 'cui_str': 'Intra-Articular Injections'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0020196', 'cui_str': 'Hyaluronic Acid'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0035168'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",379.0,0.19957,"Effectiveness of Gel-200 treatment was statistically significant over weeks 3-13 by WOMAC total score, physical function, and physician global evaluations (P<0.05).","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'H S B', 'Initials': 'HSB', 'LastName': 'Baraf', 'Affiliation': 'The Center for Rheumatology and Bone Research, Wheaton, MD, USA.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Lavin', 'Affiliation': 'Boston Biostatistics Research Foundation, Framingham, MA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Biostatistics & Data Management Group, Clinical Development Department, Research & Development Division, Seikagaku Corporation, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hosokawa', 'Affiliation': 'Clinical Development Department, Research & Development Division, Seikagaku Corporation, Chiyoda-ku, Tokyo, Japan. Electronic address: hiroyuki.hosokawa@seikagaku.co.jp.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2012.01.013']
2493,32422456,Cognitive and emotional predictors of real versus sham repetitive transcranial magnetic stimulation treatment response in methamphetamine use disorder.,"BACKGROUND AND AIMS


Repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (DLPFC) can effectively reduce cravings in methamphetamine use disorder (MUD). However, a considerable group still fails to respond. Cognitive and emotional disturbance, as well as impulsive features, are widespread in patients with MUD and might mediate the treatment response of rTMS. The purpose of this study is to figure out whether these variables can help predicting patients' responses to rTMS treatment.
METHODS


Ninety-seven patients with severe MUD and thirty-one gender- and age-matched healthy subjects were included. Patients were randomized to receive 20 sessions of real or sham rTMS. Intermittent theta burst protocols (iTBS) or sham iTBS were applied every weekday over the DLPFC for 20 daily sessions. Both groups received regular treatment. Craving induced by drug-related cue was measured before and after stimulation. Cognition was evaluated by using the CogState Battery. Baseline characteristics were collected through the Addiction Severity Index, Patient Health Questionnaire-9, General Anxiety Disorder Scale-7, and Barrett Impulsivity Scale-11.
RESULTS


Results showed that patients with MUD have worse spatial working memory, problem-solving ability, as well as depression and anxiety symptoms compared with healthy controls. Cognition and emotion differed between responders (craving decrease ≥60%) and non-responders in real rTMS group but not in the sham group. Better cognitive and emotional functions means that patients have higher possibility for better response to real rTMS treatment.
CONCLUSIONS


This study suggests that cognitive, emotional and impulsive features could be used to predict the prospective treatment responses of rTMS in patients with MUD.",2020,Cognition and emotion differed between responders (craving decrease ≥60%) and non-responders in real rTMS group but not in the sham group.,"['methamphetamine use disorder', 'Ninety-seven patients with severe MUD and thirty-one gender- and age-matched healthy subjects were included', 'patients with MUD']","['Intermittent theta burst protocols (iTBS) or sham iTBS', 'Repetitive transcranial magnetic stimulation (rTMS', '20 sessions of real or sham rTMS', 'real versus sham repetitive transcranial magnetic stimulation', 'rTMS']","['Craving', 'spatial working memory, problem-solving ability', 'Cognitive and emotional disturbance', 'depression and anxiety symptoms', 'Cognition and emotion']","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0013985', 'cui_str': 'Emotional Disturbances'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",97.0,0.0306309,Cognition and emotion differed between responders (craving decrease ≥60%) and non-responders in real rTMS group but not in the sham group.,"[{'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'Yunnan Institute on Drug Dependence, Yunnan, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Duan', 'Affiliation': 'Yunnan Institute on Drug Dependence, Yunnan, China.'}, {'ForeName': 'Congbin', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Yunnan Institute on Drug Dependence, Yunnan, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology (CEBSIT), Chinese Academy of Sciences, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.007']
2494,32422373,Add-on omalizumab for inadequately controlled severe pollinosis despite standard-of-care: a randomized study.,"BACKGROUND


Cedar pollinosis (CP), a common form of seasonal allergic rhinitis (AR), is a substantial medical problem in Japan due to its high prevalence and severe symptoms. Omalizumab (anti-IgE therapy) has previously proven effective in CP/AR, but no studies for inadequately controlled severe CP/AR despite standard-of-care (SoC) have been conducted.
OBJECTIVE


To determine the efficacy of omalizumab added to SoC in patients with inadequately controlled severe CP in a randomized, double-blinded, placebo-controlled, phase III study.
METHODS


Severe adult/adolescent CP patients whose symptoms were inadequately controlled despite nasal corticosteroids plus one or more oral medications in the previous two seasons were randomized to receive omalizumab (n = 162) or placebo (n = 175). All patients received concomitant antihistamines and nasal corticosteroids as SoC. The primary endpoint was the mean nasal symptom score during the severe symptom period. Secondary endpoints included mean ocular symptom score, quality-of-life, and safety.
RESULTS


The SoC + omalizumab treatment had statistically significantly and clinically important lower nasal (LS mean difference, -1.03, p<0.001) and ocular (-0.87, p<0.001) symptom scores compared with SoC + placebo respectively. Differences in scores for individual components of nasal and ocular symptoms were also statistically and clinically significant. SoC + Omalizumab also improved QoL scores as overall and in all domains. No unexpected safety signals were observed.
CONCLUSIONS


In severe CP patients, omalizumab added to SoC demonstrated consistent efficacy in improving symptoms and QoL, and was well-tolerated. These results indicate omalizumab could be a promising therapeutic option for severe CP/AR.",2020,"The SoC + omalizumab treatment had statistically significantly and clinically important lower nasal (LS mean difference, -1.03, p<0.001) and ocular (-0.87, p<0.001) symptom scores compared with SoC + placebo respectively.","['Severe adult/adolescent CP patients whose symptoms were inadequately controlled despite nasal corticosteroids plus one or more oral medications in the previous two seasons', 'Cedar pollinosis (CP', 'patients with inadequately controlled severe CP']","['Omalizumab (anti-IgE therapy', 'concomitant antihistamines and nasal corticosteroids as SoC', 'SoC + Omalizumab', 'omalizumab', 'SoC + placebo', 'placebo']","['individual components of nasal and ocular symptoms', 'QoL scores', 'mean ocular symptom score, quality-of-life, and safety', 'mean nasal symptom score']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0051978', 'cui_str': 'Anti-Immunoglobulin E antibody'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}]",175.0,0.216499,"The SoC + omalizumab treatment had statistically significantly and clinically important lower nasal (LS mean difference, -1.03, p<0.001) and ocular (-0.87, p<0.001) symptom scores compared with SoC + placebo respectively.","[{'ForeName': 'Kimihiro', 'Initials': 'K', 'LastName': 'Okubo', 'Affiliation': 'Department of Otolaryngology, Nippon Medical School, Tokyo, Japan;. Electronic address: ent-kimi@nms.ac.jp.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Okano', 'Affiliation': 'Department of Otorhinolaryngology, International University of Health and Welfare School of Medicine, Narita, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Novartis Pharma K.K., Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Tamaki', 'Affiliation': 'Novartis Pharma K.K., Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Novartis Pharma K.K., Tokyo, Japan.'}, {'ForeName': 'Alkaz', 'Initials': 'A', 'LastName': 'Uddin', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.04.068']
2495,22284216,Recruiting and retaining postpartum women from areas of social disadvantage in a weight-loss trial--an assessment of strategies employed in the WeighWell feasibility study.,"Little is known about the response of post-partum women from deprived backgrounds to weight management interventions, however behavioural intervention trials in disadvantaged communities are often characterised by recruitment difficulties. Recruitment and retention is key to the robust conduct of an effective trial, and exploratory work is essential prior to a definitive randomised controlled trial. This paper describes strategies used to recruit to the WeighWell feasibility study, which aimed to recruit 60 overweight or obese post-partum women living in areas of deprivation to a trial of a weight-loss intervention. Recruitment strategies included the following: (1) distribution of posters and 'business cards'; (2) newspaper advertisements; (3) visits to community groups; and (4) personalised letters of invitation sent via the National Health Service (NHS). Potential participants were screened for eligibility following response to a Freephone number. Body mass index was calculated using self-reported body weight and height. Over 6 months, 142 women responded of whom 65 (46%) met the eligibility criteria. The most effective methods for recruiting eligible women and those who went on to complete the study (n = 36) were visits to community groups (37% and 42%, respectively), personalised letters (26% and 17%, respectively) and posters and 'business cards' (22% and 31%, respectively). These results emphasise the need to utilise a range of strategies beyond traditional NHS settings. Current approaches might be enhanced by sending personal contact letters via their General Practitioner to women identified as eligible at post-natal discharge. Under-reporting of body weight by self-report suggests that a threshold lower than 25 kg/m(2) should be utilised for screening purposes.",2013,"Little is known about the response of post-partum women from deprived backgrounds to weight management interventions, however behavioural intervention trials in disadvantaged communities are often characterised by recruitment difficulties.","['142 women responded of whom 65 (46%) met the eligibility criteria', '60 overweight or obese post-partum women living in areas of deprivation to a trial of a weight-loss intervention', 'Potential participants were screened for eligibility following response to a Freephone number']",[],"[""distribution of posters and 'business cards'; (2) newspaper advertisements; (3) visits to community groups; and (4) personalised letters of invitation sent via the National Health Service (NHS"", 'Body mass index']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",[],"[{'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0376675', 'cui_str': 'Poster'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",142.0,0.0619294,"Little is known about the response of post-partum women from deprived backgrounds to weight management interventions, however behavioural intervention trials in disadvantaged communities are often characterised by recruitment difficulties.","[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Macleod', 'Affiliation': 'Centre for Public Health Nutrition Research, University of Dundee Division of Clinical, Population Sciences and Education, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Craigie', 'Affiliation': ''}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Barton', 'Affiliation': ''}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Treweek', 'Affiliation': ''}, {'ForeName': 'Annie S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2011.00393.x']
2496,31223099,Does infusion time affect the retention of parenteral trace elements?,"When readymade parenteral nutrition in multi-chamber bags is supplied without vitamins and minerals, these have to be added or given separately. Separate rapid infusion has logistical advantages but has been claimed to saturate tissue mechanisms, potentially increasing urine micronutrient losses. The present study compared urinary losses after fast (1 h) v. slow (10 h) trace elements infusion. The study enrolled thirty-nine consecutive patients who were starting parenteral nutrition postoperatively. One day's dose of a complete intravenous micronutrient product was infused over 1 h and over 10 h, in random order, with a washout day after each infusion day. Urinary Zn, Mn, Se, Cr, Cu and Fe losses were measured by 24-h urine collection, recorded for each infusion day and subsequent washout day. For Zn, a dose of 100 μmol was given, and total urinary loss over the next 2 d was mean 40·6 (sd 23·8) μmol after the fast (1 h) infusion v. 33·4 (sd 25·4) μmol after the slow (10 h) infusion, that is, 7 % more of the 1-d dose was lost after fast infusion (P = 0·01). For Mn, after a dose of 1000 nmol, losses were 9·8 (sd 23·9) nmol after the fast infusion v. 22·1 (sd 47·2) nmol after the slow infusion, that is, 1 % more of the 1-d dose was lost after slow infusion (P = 0·04). There were no other significant differences: after 1 μmol Se, the losses were 1·5 (sd 0·6) μmol fast v. 1·3 (sd 0·5) μmol slow; after 200 nmol Cr, 257 (sd 92) μmol fast v. 246 (sd 107) nmol slow; after 8 μmol Cu, 1·6 (sd 1·4) μmol fast v. 1·5 (sd 1·3) μmol slow; and after 20 μmol Fe, 0·6 (sd 1·1) μmol fast v. 0·8 (sd 1·6) μmol slow (P > 0·05 for all). Overall, trace element retention appears to be minimally affected by infusion time.",2019,"There were no other significant differences: after 1 μmol Se, the losses were 1·5",['enrolled thirty-nine consecutive patients who were starting parenteral nutrition postoperatively'],[],"['total urinary loss', 'Urinary Zn, Mn, Se, Cr, Cu and Fe losses']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429778', 'cui_str': 'Urinary loss'}]",39.0,0.115418,"There were no other significant differences: after 1 μmol Se, the losses were 1·5","[{'ForeName': 'Suzie', 'Initials': 'S', 'LastName': 'Ferrie', 'Affiliation': 'Department of Nutrition and Dietetics, Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW 2050, Australia.'}]",The British journal of nutrition,['10.1017/S0007114519000965']
2497,31247558,Prognostic and Monitory EEG-Biomarkers for BCI Upper-Limb Stroke Rehabilitation.,"With the availability of multiple rehabilitative interventions, identifying the one that elicits the best motor outcome based on the unique neuro-clinical profile of the stroke survivor is a challenging task. Predicting the potential of recovery using biomarkers specific to an intervention hence becomes important. To address this, we investigate intervention-specific prognostic and monitory biomarkers of motor function improvements using quantitative electroencephalography (QEEG) features in 19 chronic stroke patients following two different upper extremity rehabilitative interventions viz. Brain-computer interface (BCI) and transcranial direct current stimulation coupled BCI (tDCS-BCI). Brain symmetry index was found to be the best prognostic QEEG for clinical gains following BCI intervention ( r = -0.80 , p = 0.02 ), whereas power ratio index (PRI) was observed to be the best predictor for tDCS-BCI ( r = -0.96 , p = 0.004 ) intervention. Importantly, statistically significant between-intervention differences observed in the predictive capabilities of these features suggest that intervention-specific biomarkers can be identified. This approach can be further pursued to distinctly predict the expected response of a patient to available interventions. The intervention with the highest predicted gains may then be recommended to the patient, thereby enabling a personalized rehabilitation regime.",2019,"Brain symmetry index was found to be the best prognostic QEEG for clinical gains following BCI intervention ( r = -0.80 , p = 0.02 ), whereas power ratio index (PRI) was observed to be the best predictor for tDCS-BCI ( r = -0.96 , p = 0.004 ) intervention.",['19 chronic stroke patients following two different upper extremity rehabilitative interventions viz'],"['Brain-computer interface (BCI) and transcranial direct current stimulation coupled BCI (tDCS-BCI', 'quantitative electroencephalography (QEEG']","['Brain symmetry index', 'power ratio index (PRI']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]",19.0,0.0157026,"Brain symmetry index was found to be the best prognostic QEEG for clinical gains following BCI intervention ( r = -0.80 , p = 0.02 ), whereas power ratio index (PRI) was observed to be the best predictor for tDCS-BCI ( r = -0.96 , p = 0.004 ) intervention.","[{'ForeName': 'Ravikiran', 'Initials': 'R', 'LastName': 'Mane', 'Affiliation': ''}, {'ForeName': 'Effie', 'Initials': 'E', 'LastName': 'Chew', 'Affiliation': ''}, {'ForeName': 'Kok Soon', 'Initials': 'KS', 'LastName': 'Phua', 'Affiliation': ''}, {'ForeName': 'Kai Keng', 'Initials': 'KK', 'LastName': 'Ang', 'Affiliation': ''}, {'ForeName': 'Neethu', 'Initials': 'N', 'LastName': 'Robinson', 'Affiliation': ''}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Vinod', 'Affiliation': ''}, {'ForeName': 'Cuntai', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2019.2924742']
2498,31916717,The effects of enteral artificial amniotic fluid-containing erythropoietin on short term outcomes of preterm infants.,"Hosseini M, Azampour H, Raeisi S, Behtari M, Valizadeh H, Saboohi R. The effects of enteral artificial amniotic fluid-containing erythropoietin on short term outcomes of preterm infants. Turk J Pediatr 2019; 61: 392-398. Necrotizing Enterocolitis (NEC) is a common devastating gastrointestinal disease, which usually develops in premature infants. Erythropoietin (EPO) as a hematopoietic hormone produced by the kidney can also be naturally found in amniotic fluid and breast milk. There is some evidence that supports the contribution of EPO in the prevention of inflammation and intestinal tissue repair. This study was aimed to determine if oral administration of artificial amniotic fluid with or without EPO would protect preterm infants against NEC and improve the certain neonatal outcomes. In this study, 150 preterm infants with gestational age 28 weeks or less and birth weight 1250 grams or less were enrolled. The infants were divided randomly into 3 groups: 1) Control group (n=50) with routine feeding protocol without any administration; 2) Amniotic fluid group (n=50) with 5mL/kg synthetic amniotic fluid; 3) EPO group (n=50) with RhuEPO dissolved in the synthetic amniotic fluid. The administrations of the study solution were started 3 days after the birth and were continued for 3 weeks (21 days). The infants in the study groups were followed up until discharge and the frequency of NEC, mortality, and other complications of the disease among the groups were compared. The mortality rate in preterm infants of the amniotic fluid and EPO groups were significantly lower than in the control group (p=0.027). We couldn`t find any significant differences in the frequency of NEC and other complications among the three study groups. The administration of synthetic amniotic fluid (with or without EPO) in preterm infants may decrease the mortality rate. Use of EPO in synthetic amniotic fluid did not affect the frequency of NEC.",2019,The mortality rate in preterm infants of the amniotic fluid and EPO groups were significantly lower than in the control group (p=0.027).,"['150 preterm infants with gestational age 28 weeks or less and birth weight 1250 grams or less were enrolled', 'preterm infants', 'premature infants']","['Control group (n=50) with routine feeding protocol without any administration; 2) Amniotic fluid group (n=50) with 5mL/kg synthetic amniotic fluid; 3) EPO group (n=50) with RhuEPO dissolved in the synthetic amniotic fluid', 'synthetic amniotic fluid (with or without EPO', 'artificial amniotic fluid with or without EPO', 'Erythropoietin (EPO', 'enteral artificial amniotic fluid-containing erythropoietin', 'EPO']","['frequency of NEC', 'mortality rate', 'Necrotizing Enterocolitis (NEC', 'Hosseini M, Azampour H, Raeisi S, Behtari M, Valizadeh H, Saboohi R']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002638', 'cui_str': 'Amniotic Fluid'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4521688', 'cui_str': 'Dissolve (transformation)'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}]",,0.0890697,The mortality rate in preterm infants of the amniotic fluid and EPO groups were significantly lower than in the control group (p=0.027).,"[{'ForeName': 'Mohammadbagher', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Azampour', 'Affiliation': 'Department of Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Raeisi', 'Affiliation': 'Department of Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Behtari', 'Affiliation': 'Department of Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Valizadeh', 'Affiliation': 'Department of Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Saboohi', 'Affiliation': 'Department of Neonatology, Al-Zahra Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",The Turkish journal of pediatrics,['10.24953/turkjped.2019.03.011']
2499,32019539,"Comparative effectiveness of an economic empowerment program on adolescent economic assets, education and health in a humanitarian setting.","BACKGROUND


Adolescence is a critical period of human development, however, limited research on programs to improve health and well-being among younger adolescents living in conflict-affected and humanitarian settings exists. The purpose of this study was to assess the comparative effectiveness of an economic empowerment program on young adolescent outcomes in a complex humanitarian setting.
METHODS


This longitudinal, mixed methods study examined the relative effectiveness of an integrated parent (Pigs for Peace, PFP) and young adolescent (Rabbits for Resilience, RFR) animal microfinance/asset transfer program (RFR + PFP) on adolescent outcomes of asset building, school attendance, mental health, experienced stigma, and food security compared to RFR only and PFP only over 24 months. A sub-sample of young adolescents completed in-depth qualitative interviews on the benefits and challenges of participating in RFR.
RESULTS


Five hundred forty-two young adolescents (10-15 years) participated in three groups: RFR + PFP (N = 178), RFR only (N = 187), PFP only (N = 177). 501 (92.4%) completed baseline surveys, with 81.7% (n = 442) retention at endline. The group by time interaction (24 months) was significant for adolescent asset building (X 2  = 16.54, p = .002), school attendance (X 2  = 12.33, p = .015), and prosocial behavior (X 2  = 10.56, p = .032). RFR + PFP (ES = 0.31, ES = 0.38) and RFR only (ES-0.39, ES = 0.14) adolescents had greater improvement in asset building and prosocial behavior compared to PFP only, respectively. The odds of missing two or more days of school in the past month were 78.4% lower in RFR only and 45.1% lower in RFR + PFP compared to PFP only. No differences between groups in change over time were found for internalizing behaviors, experienced stigma, or food security. Differences by age and gender were observed in asset building, prosocial behavior, school attendance, experienced stigma, and food security. The voices of young adolescents identified the benefits of the RFR program through their ability to pay for school fees, help their families meet basic needs, and the respect they gained from family and community. Challenges included death of rabbits and potential conflict within the household on how to use the rabbit asset.
CONCLUSION


These findings underscore the potential for integrating economic empowerment programs with both parents and young adolescents to improve economic, educational, and health outcomes for young adolescents growing up in rural and complex humanitarian settings.
TRIAL REGISTRATION


NCT02008695. Retrospectively registered 11 December 2013.",2020,"Differences by age and gender were observed in asset building, prosocial behavior, school attendance, experienced stigma, and food security.","['Five hundred forty-two young adolescents (10-15\u2009years) participated in three groups', 'young adolescent (Rabbits for Resilience, RFR) animal', 'young adolescents', 'young adolescent outcomes in a complex humanitarian setting']","['RFR\u2009+\u2009PFP', 'microfinance/asset transfer program (RFR\u2009+\u2009PFP', 'economic empowerment program', 'integrated parent (Pigs for Peace, PFP']","['adolescent economic assets, education and health', 'internalizing behaviors, experienced stigma, or food security', 'school attendance', 'asset building and prosocial behavior', 'asset building, prosocial behavior, school attendance, experienced stigma, and food security', 'RFR', 'adolescent outcomes of asset building, school attendance, mental health, experienced stigma, and food security', 'death of rabbits and potential conflict', 'prosocial behavior']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0324889', 'cui_str': 'Oryctolagus cuniculus'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0937858', 'cui_str': 'Perflutren'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0324889', 'cui_str': 'Oryctolagus cuniculus'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]",542.0,0.0253326,"Differences by age and gender were observed in asset building, prosocial behavior, school attendance, experienced stigma, and food security.","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, Maryland, USA. nglass1@jhu.edu.'}, {'ForeName': 'Mitima Mpanano', 'Initials': 'MM', 'LastName': 'Remy', 'Affiliation': ""Programme d'Appui aux Initiatives Economiques (PAIDEK), Bukavu, Democratic Republic of Congo.""}, {'ForeName': 'Larissa Jennings', 'Initials': 'LJ', 'LastName': 'Mayo-Wilson', 'Affiliation': 'School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Anjalee', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'Institute of Reproductive Health, Georgetown University, Washington, District of Columbia, USA.'}, {'ForeName': 'Marni', 'Initials': 'M', 'LastName': 'Sommer', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, New York, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Turner', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Perrin', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, Maryland, USA.'}]",BMC public health,['10.1186/s12889-020-8219-6']
2500,32422285,Randomized trial of topical periocular castor oil treatment for blepharitis.,"PURPOSE


To evaluate the effects of topical castor oil application to the eyelids on ocular surface and tear film parameters in patients with blepharitis.
METHODS


Twenty-six participants (14 females, 12 males; mean ± SD age, 38 ± 21 years) with clinical signs of blepharitis were enrolled in a prospective, investigator-masked, randomized, paired-eye trial. A 100% cold pressed castor oil formulation (Lotus Garden Botanicals, Biddeford, ME, USA) was applied to the eyelids of one eye (randomized), twice daily for 4 weeks. Ocular surface characteristics, symptoms, and tear film parameters were assessed at baseline and day 28.
RESULTS


Baseline measurements did not differ between treated and control eyes (all p > 0.05). A significant reduction in OSDI symptomology score was observed following the four-week treatment period (p = 0.001). Clinical improvements in eyelid margin thickening, telangiectasia, eyelash matting, madarosis, cylindrical dandruff, and lid wiper epitheliopathy were limited to treated eyes (all p < 0.01), while greater decreases in staphylococcal and seborrheic eyelash crusting were observed in treated than control eyes (both p < 0.05). No adverse events were reported during the treatment period.
CONCLUSION


Topical castor oil application effected significant improvements in ocular surface signs and symptoms in patients with blepharitis. The favourable therapeutic profile would suggest that castor oil demonstrates promise as a potential treatment for blepharitis, and support further efficacy trials with longer follow up.
TRIAL REGISTRATION NUMBER


ACTRN12618000856213.",2020,"RESULTS


Baseline measurements did not differ between treated and control eyes (all p > 0.05).","['Twenty-six participants (14 females, 12 males; mean\u202f±\u202fSD age, 38\u202f±\u202f21 years) with clinical signs of blepharitis', 'patients with blepharitis', 'blepharitis']","['topical castor oil application', 'cold pressed castor oil formulation (Lotus Garden Botanicals, Biddeford, ME, USA', 'topical periocular castor oil treatment', 'castor oil']","['staphylococcal and seborrheic eyelash crusting', 'Ocular surface characteristics, symptoms, and tear film parameters', 'OSDI symptomology score', 'ocular surface and tear film parameters', 'adverse events', 'ocular surface signs and symptoms', 'eyelid margin thickening, telangiectasia, eyelash matting, madarosis, cylindrical dandruff, and lid wiper epitheliopathy']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0007343', 'cui_str': 'Castor Oil'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0330839', 'cui_str': 'Lotus'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015422', 'cui_str': 'Structure of eyelash'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0449588', 'cui_str': 'Surface characteristics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0271321', 'cui_str': 'Madarosis of eyelid'}, {'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0221244', 'cui_str': 'Seborrheic dermatitis of scalp'}]",26.0,0.0298868,"RESULTS


Baseline measurements did not differ between treated and control eyes (all p > 0.05).","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Muntz', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sandford', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand; Tauranga Eye Specialists, Tauranga, New Zealand.'}, {'ForeName': 'Marna', 'Initials': 'M', 'LastName': 'Claassen', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand; Department of Optometry and Vision Science, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Curd', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand; Department of Optometry and Vision Science, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Alice K', 'Initials': 'AK', 'LastName': 'Jackson', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand; Department of Optometry and Vision Science, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Watters', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Michael T M', 'Initials': 'MTM', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Craig', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand. Electronic address: jp.craig@auckland.ac.nz.'}]",The ocular surface,['10.1016/j.jtos.2020.05.007']
2501,22238561,A Diet and Exercise Intervention during Chemotherapy for Breast Cancer.,"Weight gain is an important concern that impacts on breast cancer outcomes and general health in survivorship. This randomized, pilot study evaluated whether or not women could comply with a weight control program that is initiated at the beginning of chemotherapy for breast cancer. The program sought to prevent weight gain using a low-fat, high fruit-vegetable diet combined with moderate physical activity. The intervention was implemented using a telephone counseling approach that blended motivational interviewing with social cognitive theory. A total of 40 women were recruited over 9 months at the University of Michigan Comprehensive Cancer Center. This represents 55% of eligible women referred to the study and indicates that interest in a healthy lifestyle program at the initiation of chemotherapy for breast cancer was high. Subjects who dropped out had significantly lower fruit and vegetable intakes and lower blood carotenoids at baseline than subjects who completed the study. Statistically significant beneficial effects were observed on fruit and vegetable intakes, physical activity and breast cancer-specific well-being by the intervention. Mean body fat from dual energy X-ray absorptiometry increased in the written materials arm and decreased in the intervention arm. Of the enrolled women, 75% completed 12 months on study and satisfaction with study participation was high. These data indicate that lifestyle intervention during breast cancer treatment is feasible during treatment with chemotherapy for breast cancer and benefits women in several domains.",2011,"Statistically significant beneficial effects were observed on fruit and vegetable intakes, physical activity and breast cancer-specific well-being by the intervention.","['A total of 40 women were recruited over 9 months at the University of Michigan Comprehensive Cancer Center', 'Breast Cancer']","['lifestyle intervention', 'Diet and Exercise Intervention', 'telephone counseling approach that blended motivational interviewing with social cognitive theory', 'weight gain using a low-fat, high fruit-vegetable diet combined with moderate physical activity']","['fruit and vegetable intakes and lower blood carotenoids', 'fruit and vegetable intakes, physical activity and breast cancer-specific well-being', 'Mean body fat from dual energy X-ray absorptiometry']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3714364', 'cui_str': 'Counseling approach'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]",40.0,0.0118589,"Statistically significant beneficial effects were observed on fruit and vegetable intakes, physical activity and breast cancer-specific well-being by the intervention.","[{'ForeName': 'Zora', 'Initials': 'Z', 'LastName': 'Djuric', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI 48109.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Ellsworth', 'Affiliation': ''}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Weldon', 'Affiliation': ''}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Richardson', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': ''}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': ''}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': ''}]",The open obesity journal,[]
2502,32021173,New Approaches in Breast Cancer Therapy Through Green Nanotechnology and Nano-Ayurvedic Medicine - Pre-Clinical and Pilot Human Clinical Investigations.,"Purpose


The overarching objective of this investigation was to investigate the intervention of green nanotechnology to transform the ancient holistic Ayurvedic medicine scientifically credible through reproducible formulations and rigorous pre-clinical/clinical evaluations.
Methods


We provide, herein, full details: (i) on the discovery and full characterization of gold nanoparticles-based Nano Swarna Bhasma (henceforth referred to as NSB drug); (ii) In vitro anti-tumor properties of NSB drug in breast tumor cells; (iii) pre-clinical therapeutic efficacy studies of NSB drug in breast tumor bearing SCID mice through oral delivery protocols and (iv) first results of clinical translation, from mice to human breast cancer patients, through pilot human clinical trials, conducted according to the Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (abbreviated as AYUSH) regulatory guidelines of the Government of India in metastatic breast cancer patients.
Results


The preclinical in vitro and in vivo investigations, in breast tumor bearing mice, established unequivocally that the NSB Nano-Ayurvedic medicine-gold nanoparticles-based drug is highly effective in controlling the growth of breast tumors in a dose dependent fashion in vivo. These encouraging pre-clinical results prompted us to seek permission from the Indian Government's holistic medicine approval authority, AYUSH, for conducting clinical trials in human patients. Patients treated with the NSB drug capsules along with the ""standard of care treatment"" (Arm B) exhibited 100% clinical benefits when compared to patients in the treatment Arm A, thus indicating the tremendous clinical benefits of NSB drug in adjuvant therapy.
Conclusion


We have succeeded in clinically translating, from mice to humans, in using proprietary combinations of gold nanoparticles and phytochemicals to develop the Nano-Ayurvedic drug: Nano Swarna Bhasma (NSB), through innovative green nanotechnology, for treating human metastatic breast cancer patients.",2020,"Patients treated with the NSB drug capsules along with the ""standard of care treatment"" (Arm B) exhibited 100% clinical benefits when compared to patients in the treatment Arm A, thus indicating the tremendous clinical benefits of NSB drug in adjuvant therapy.
","['metastatic breast cancer patients', 'human breast cancer patients', 'human metastatic breast cancer patients', 'human patients']","['NSB drug in adjuvant therapy', 'NSB', 'gold nanoparticles-based Nano Swarna Bhasma (henceforth']",[],"[{'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.029178,"Patients treated with the NSB drug capsules along with the ""standard of care treatment"" (Arm B) exhibited 100% clinical benefits when compared to patients in the treatment Arm A, thus indicating the tremendous clinical benefits of NSB drug in adjuvant therapy.
","[{'ForeName': 'Menka', 'Initials': 'M', 'LastName': 'Khoobchandani', 'Affiliation': 'Department of Radiology, University of Missouri, Columbia, MO 65212, USA.'}, {'ForeName': 'Kavita K', 'Initials': 'KK', 'LastName': 'Katti', 'Affiliation': 'Department of Radiology, University of Missouri, Columbia, MO 65212, USA.'}, {'ForeName': 'Alice Raphael', 'Initials': 'AR', 'LastName': 'Karikachery', 'Affiliation': 'Department of Radiology, University of Missouri, Columbia, MO 65212, USA.'}, {'ForeName': 'Velaphi C', 'Initials': 'VC', 'LastName': 'Thipe', 'Affiliation': 'Department of Radiology, University of Missouri, Columbia, MO 65212, USA.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Srisrimal', 'Affiliation': 'Dhanvantari Nano Ayushadi Pvt Ltd, Chennai 600017, India.'}, {'ForeName': 'Darsha Kumar', 'Initials': 'DK', 'LastName': 'Dhurvas Mohandoss', 'Affiliation': 'Dhanvantari Nano Ayushadi Pvt Ltd, Chennai 600017, India.'}, {'ForeName': 'Rashmi Dhurvas', 'Initials': 'RD', 'LastName': 'Darshakumar', 'Affiliation': 'Dhanvantari Nano Ayushadi Pvt Ltd, Chennai 600017, India.'}, {'ForeName': 'Chintamani M', 'Initials': 'CM', 'LastName': 'Joshi', 'Affiliation': 'Dhanvantari Nano Ayushadi Pvt Ltd, Chennai 600017, India.'}, {'ForeName': 'Kattesh V', 'Initials': 'KV', 'LastName': 'Katti', 'Affiliation': 'Department of Radiology, University of Missouri, Columbia, MO 65212, USA.'}]",International journal of nanomedicine,['10.2147/IJN.S219042']
2503,32423935,Innovative equipment to monitor and control salt usage when cooking at home: iMC SALT research protocol for a randomised controlled trial.,"INTRODUCTION


Excessive salt intake is a public health concern due to its deleterious impact on health. Most of the salt consumed come from those that are added when cooking. This study will improve knowledge on the effectiveness of interventions to reduce salt consumption among consumers.
METHODS AND ANALYSIS


In this randomised clinical trial, we will be evaluating the efficacy of an intervention-the Salt Control H, an innovative prototype equipment to monitor and control use of salt when cooking-among workers from a public university, with the aim of reducing their dietary salt intake. We will randomly select 260 workers who meet the eligibility criteria and who are enrolled to an occupational health appointment and randomise them into one of the two arms of the study (either control or intervention), with matched baseline characteristics (sex and hypertension). The intervention will last for 8 weeks, during which the participants will use the equipment at home to monitor and control their use of salt when cooking. The main outcome will be 24-hour urinary sodium excretion at baseline, at fourth and eighth weeks of intervention, and at 6 months after intervention.
ETHICS AND DISSEMINATION


Ethical approval for the study has been obtained from the Ethics Committee of the Centro Hospitalar Universitário São João. The results of the investigation will be published in peer-reviewed scientific papers and presented at international conferences.
TRIAL REGISTRATION NUMBER


NCT03974477 EQUIPMENT PROVISIONAL PATENT NUMBER: Registered at INPI: 20191000033265.",2020,"In this randomised clinical trial, we will be evaluating the efficacy of an intervention-the Salt Control H, an innovative prototype equipment to monitor and control use of salt when cooking-among workers from a public university, with the aim of reducing their dietary salt intake.","['260 workers who meet the eligibility criteria and who are enrolled to an occupational health appointment and randomise them into one of the two arms of the study (either control or intervention), with matched baseline characteristics (sex and hypertension', 'workers from a public university']",[],['24-hour urinary sodium excretion'],"[{'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],"[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",,0.0781949,"In this randomised clinical trial, we will be evaluating the efficacy of an intervention-the Salt Control H, an innovative prototype equipment to monitor and control use of salt when cooking-among workers from a public university, with the aim of reducing their dietary salt intake.","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Gonçalves', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal carlagoncalves.pt@gmail.com.'}, {'ForeName': 'Tânia', 'Initials': 'T', 'LastName': 'Silva-Santos', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Abreu', 'Affiliation': 'CIAFEL - Centro de Investigação em Atividade Física, Saúde e Lazer, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Padrão', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Graça', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Oliveira', 'Affiliation': 'INEGI - Instituto de Engenharia Mecânica e Gestão Industrial, Porto, Portugal.'}, {'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Esteves', 'Affiliation': 'INEGI - Instituto de Engenharia Mecânica e Gestão Industrial, Porto, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Norton', 'Affiliation': 'UP EPIUnit - Institute of Public Health, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Moreira', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Olívia', 'Initials': 'O', 'LastName': 'Pinho', 'Affiliation': 'Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Porto, Portugal.'}]",BMJ open,['10.1136/bmjopen-2019-035898']
2504,32423930,"Efficacy and safety of xuezhikang once per day versus two times per day in patients with mild to moderate hypercholesterolaemia (APEX study): a protocol for a multicentre, prospective randomised controlled, open-label, non-inferiority study.","INTRODUCTION


Reduction in low-density lipoprotein cholesterol (LDL-C) improves clinical outcomes in patients with coronary artery disease. However, rates of lipid-lowering medication adherence are far from ideal. Reducing dosage frequency from multiple dosing to once-daily dosing may improve patients' medication adherence. Xuezhikang (XZK), an extract of Chinese red yeast rice, contains a family of naturally occurring statins and is traditionally prescribed as 600 mg two times per day. A comParative Efficacy study of XZK (APEX study) is designed to test the hypothesis that XZK prescribed 1200 mg once per day (OD group) is non-inferior to 600 mg two times per day (TD group) in patients with hypercholesterolaemia.
METHODS AND ANALYSIS


The APEX study is a multicentre, prospective randomised controlled, open-label, non-inferiority study. We plan to recruit 316 patients aged ≥18 years with a diagnosis of mild to moderate hypercholesterolaemia for primary prevention. Patients will be randomised (1:1) to OD group and TD group. The OD group take XZK 1200 mg once per day after dinner while TD group take a traditional dose of 600 mg, two times per day after meals. Participants will have an 8-week medication period and be followed up at weeks 0, 4 and 8. The primary end point is the mean percentage change from baseline to week 8 in serum LDL-C. Secondary end points are safety and lipid-lowering effect on other lipoproteins and compliance. Data analyses will be on the intention-to-treat principle using non-inferiority analysis.
ETHICS AND DISSEMINATION


The research had been approved by the Clinical Research and Laboratory Animal Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University ((2017)286). The results will be reported through peer-reviewed journals, seminars and conference presentations.
TRIAL REGISTRATION NUMBER


ChiCTR-IIR-17013660.",2020,The primary end point is the mean percentage change from baseline to week 8 in serum LDL-C. Secondary end points are safety and lipid-lowering effect on other lipoproteins and compliance.,"['patients with mild to moderate hypercholesterolaemia (APEX study', 'patients with hypercholesterolaemia', '316 patients aged ≥18 years with a diagnosis of mild to moderate hypercholesterolaemia for primary prevention', 'patients with coronary artery disease']","['XZK', 'xuezhikang', 'Xuezhikang (XZK']","['safety and lipid-lowering effect on other lipoproteins and compliance', 'rates of lipid-lowering medication adherence', 'Efficacy and safety', ""patients' medication adherence""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1566069', 'cui_str': 'xuezhikang'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",316.0,0.138285,The primary end point is the mean percentage change from baseline to week 8 in serum LDL-C. Secondary end points are safety and lipid-lowering effect on other lipoproteins and compliance.,"[{'ForeName': 'Zexuan', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Dexi', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jingzhou', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ailan', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Dong-Dan', 'Initials': 'DD', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, The Eastern Hospital of the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jianhao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Central Hospital of Panyu District, Guangzhou, China.'}, {'ForeName': 'Yugang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China yilichen2018@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-034585']
2505,31832789,Importance of infarct size versus other variables for clinical outcomes after PPCI in STEMI patients.,"Despite promising experimental studies and encouraging proof-of-concept clinical trials, interventions aimed at limiting infarct size have failed to improve clinical outcomes in patients with ST-elevation myocardial infarction (STEMI). Our objective was to examine whether variables (cardiovascular risk factors, comorbidities, post-procedural variables, cotreatments) might be associated with clinical outcomes in STEMI patients independently from infarct size reduction. The present study was based on a post hoc analysis of the CIRCUS trial database (Clinicaltrials.gov NCT01502774) that assessed the clinical benefit of a single intravenous bolus of cyclosporine in 969 patients with anterior STEMI. Since cyclosporine had no detectable effect on clinical outcomes as well as on any measured variable, we here considered the whole study population as one group. Multivariate analysis was performed to address the respective weight of infarct size and variables in clinical outcomes. Multivariate analysis revealed that several variables (including gender, hypertension, renal dysfunction, TIMI flow grade post-PCI < 3, and treatment administered after PCI with betablockers and angiotensin-converting enzyme inhibitors) had per se a significant influence on the occurrence of [death or hospitalization for heart failure] at 1 year. The relative weight of infarct size and variables on the composite endpoint of [death or hospitalization for heart failure] at 1 year was 18% and 82%, respectively. Several variables contribute strongly to the clinical outcomes of STEMI patients suggesting that cardioprotective strategy might not only focus on infarct size reduction.",2019,"The relative weight of infarct size and variables on the composite endpoint of [death or hospitalization for heart failure] at 1 year was 18% and 82%, respectively.","['STEMI patients', '969 patients with anterior\xa0STEMI', 'patients with ST-elevation myocardial infarction (STEMI']",['cyclosporine'],"['occurrence of [death or hospitalization for heart failure', 'relative weight of infarct size and variables on the composite endpoint of [death or hospitalization for heart failure']","[{'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",969.0,0.179899,"The relative weight of infarct size and variables on the composite endpoint of [death or hospitalization for heart failure] at 1 year was 18% and 82%, respectively.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bochaton', 'Affiliation': 'INSERM UMR 1060, CarMeN Laboratory, University Claude Bernard Lyon1, IHU OPeRa, Hôpital Louis Pradel, Hospices Civils de Lyon, 69677, Lyon, France.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Claeys', 'Affiliation': 'Department of Cardiology, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garcia-Dorado', 'Affiliation': ""Hospital Universitari Vall d´Hebron, Department of Cardiology, Vall d'Hebron Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Mewton', 'Affiliation': 'INSERM UMR 1060, CarMeN Laboratory, University Claude Bernard Lyon1, IHU OPeRa, Hôpital Louis Pradel, Hospices Civils de Lyon, 69677, Lyon, France.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Bergerot', 'Affiliation': 'INSERM UMR 1060, CarMeN Laboratory, University Claude Bernard Lyon1, IHU OPeRa, Hôpital Louis Pradel, Hospices Civils de Lyon, 69677, Lyon, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jossan', 'Affiliation': ""Service d'Explorations Fonctionnelles Cardiovasculaires CIC 1407 de Lyon, Hôpital Louis Pradel, Hospices Civils de Lyon, 69677, Lyon, France.""}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Amaz', 'Affiliation': ""Service d'Explorations Fonctionnelles Cardiovasculaires CIC 1407 de Lyon, Hôpital Louis Pradel, Hospices Civils de Lyon, 69677, Lyon, France.""}, {'ForeName': 'Inesse', 'Initials': 'I', 'LastName': 'Boussaha', 'Affiliation': ""Service d'Explorations Fonctionnelles Cardiovasculaires CIC 1407 de Lyon, Hôpital Louis Pradel, Hospices Civils de Lyon, 69677, Lyon, France.""}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Thibault', 'Affiliation': 'INSERM UMR 1060, CarMeN Laboratory, University Claude Bernard Lyon1, IHU OPeRa, Hôpital Louis Pradel, Hospices Civils de Lyon, 69677, Lyon, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ovize', 'Affiliation': 'INSERM UMR 1060, CarMeN Laboratory, University Claude Bernard Lyon1, IHU OPeRa, Hôpital Louis Pradel, Hospices Civils de Lyon, 69677, Lyon, France. michel.ovize@chu-lyon.fr.'}]",Basic research in cardiology,['10.1007/s00395-019-0764-8']
2506,21736700,Mother's perceptions and experiences of infant feeding within a community-based peer counselling intervention in South Africa.,"Exclusive breastfeeding (EBF) has the potential to significantly reduce infant mortality, but is frequently not practiced in low-income settings where infants are vulnerable to malnutrition and infections including human immunodeficiency virus (HIV). This study explores mothers' experiences of infant feeding after receiving peer counselling promoting exclusive breast or formula feeding. This qualitative study was embedded in a cluster randomized peer counselling intervention trial in South Africa that aimed to evaluate the effect of peer counselling on EBF. Participants were selected from the three districts that were part of the trial reflecting different socio-economic conditions, rural-urban locations and HIV prevalence rates. Seventeen HIV-positive and -negative mothers allocated to intervention clusters were recruited. Despite perceived health and economic benefits of breastfeeding, several barriers to EBF remained, which contributed to a preference for mixed feeding. The understanding of the promotional message of 'exclusive' feeding was limited to 'not mixing two milks': breast or formula and did not address early introduction of foods and other liquids. Further, a crying infant or an infant who did not sleep at night were given as strong reasons for introducing semi-solid foods as early as 1 month. In addition, the need to adhere to the cultural practice of 'cleansing' and the knowledge that this practice is not compatible with EBF appeared to promote the decision to formula feed in HIV-positive mothers. Efforts to reduce barriers to EBF need to be intensified and further take into account the strong cultural beliefs that promote mixed feeding.",2012,The understanding of the promotional message of 'exclusive' feeding was limited to 'not mixing two milks': breast or formula and did not address early introduction of foods and other liquids.,"['Participants were selected from the three districts that were part of the trial reflecting different socio-economic conditions, rural-urban locations and HIV prevalence rates', ""Mother's perceptions and experiences of infant feeding within a community-based peer counselling intervention in South Africa"", 'Seventeen HIV-positive and -negative mothers allocated to intervention clusters were recruited', ""mothers' experiences of infant feeding after receiving""]","['peer counselling promoting exclusive breast or formula feeding', 'Exclusive breastfeeding (EBF']",[],"[{'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0013551', 'cui_str': 'Economic Conditions'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}]",[],,0.0294418,The understanding of the promotional message of 'exclusive' feeding was limited to 'not mixing two milks': breast or formula and did not address early introduction of foods and other liquids.,"[{'ForeName': 'Barni', 'Initials': 'B', 'LastName': 'Nor', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden. barni.nor@kbh.uu.se""}, {'ForeName': 'Beth Maina', 'Initials': 'BM', 'LastName': 'Ahlberg', 'Affiliation': ''}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Doherty', 'Affiliation': ''}, {'ForeName': 'Yanga', 'Initials': 'Y', 'LastName': 'Zembe', 'Affiliation': ''}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'Eva-Charlotte', 'Initials': 'EC', 'LastName': 'Ekström', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2011.00332.x']
2507,32423936,Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial.,"INTRODUCTION


Exercise interventions have a strong evidence base for falls prevention. However, exercise can be challenging to implement and often has limited reach and poor adherence. Digital technology provides opportunities for both increased access to the intervention and support over time. Further knowledge needs to be gained regarding the effectiveness of completely self-managed digital exercise interventions. The main objective of this study is to compare the effectiveness of a self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone, on falls over 1 year in older community-dwelling adults.
METHODS AND ANALYSIS


A two-arm parallel randomised controlled trial will be conducted with at least 1400 community-living older adults (70+ years) who experience impaired balance. Participants will be recruited throughout Sweden with enrolment through the project website. They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone. Participants receiving the exercise intervention will be asked to exercise at home for at least 30 min, 3 times/week with support of the Safe Step application. The primary outcome will be rate of falls (fall per person year). Participants will keep a fall calendar and report falls at the end of each month through a digital questionnaire. Further assessments of secondary outcomes will be made through self-reported questionnaires and a self-test of 30 s chair stand test at baseline and 3, 6, 9 and 12 months after study start. Data will be analysed according to the intention-to-treat principle.
ETHICS AND DISSEMINATION


Ethical approval was obtained by The Regional Ethical Review Board in Umeå (Dnr 2018/433-31). Findings will be disseminated through the project web-site, peer-reviewed journals, national and international conferences and through senior citizen organisations' newsletters.
TRIAL REGISTRATION NUMBER


NCT03963570.",2020,"They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone.","['older community-dwelling adults', 'Participants will be recruited throughout Sweden with enrolment through the project website', '1400 community-living older adults (70+ years) who experience impaired balance']","['exercise intervention', 'self-managed digital exercise programme', 'self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone', 'Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone']",['rate of falls (fall per person year'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0557143', 'cui_str': 'Lives in a community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C2963171', 'cui_str': 'Healthy Ageing'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.158995,"They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone.","[{'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Pettersson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden beatrice.pettersson@umu.se.'}, {'ForeName': 'Lillemor', 'Initials': 'L', 'LastName': 'Lundin-Olsson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Dawn A', 'Initials': 'DA', 'LastName': 'Skelton', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Liv', 'Affiliation': 'Department of Public Health and Clinical Medicine, Section of Sustainable Health, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Zingmark', 'Affiliation': 'Health and Social Care Administration, Municipality of Östersund, Östersund, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Rosendahl', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Sandlund', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-036194']
2508,31830885,"Effects of N-acetylcysteine on Pulmonary Functions in Patients with Systemic Sclerosis: A Randomized Double Blind, Placebo Controlled Study.","BACKGROUND


Systemic sclerosis (SSc) is a systematic and rare autoimmune disease that affects many organs. N-acetylcysteine (NAC), thiol-containing compound, can act both as the precursor of reduced glutathione and direct scavenger of reactive oxygen species.
OBJECTIVE


We assessed the clinical effect of NAC on the pulmonary function test of patients with diffuse scleroderma.
METHODS


This study is a randomized double-blind clinical trial that was done on 25 patients with diffuse SSc without lung involvement on primary chest high-resolution computed tomography. Placebo was administered for 13 patients and 1200 milligram NAC for 12 patients. Body plethysmography parameters were assessed at the beginning of the study and after 24 weeks.
RESULTS


Patients in the two groups were matched in the basic demographic data like age, duration of disease, and modified Rodnan skin score. The analysis showed no significant differences in parameters of plethysmography between the two groups. After importing the data of 2 patients in the placebo-treated group, who developed interstitial lung disease, DLCO in the placebo-treated group was 90.69 ± 21.29 milliliter at the end of the study, which significantly decreased compared with the beginning of the study (102.30 ± 13.83 ml). Also, changes of DLCO between the two groups were significantly different.
CONCLUSION


In this trial, the sensitivity of DLCO as the first marker in the evaluation of pulmonary function in patients with SSc was confirmed. On the other hand, NAC had no effect versus placebo in a period of 24 weeks.",2020,The analysis showed no significant differences in parameters of plethysmography between the two groups.,"['patients with SSc', 'Patients in the two groups were matched in the basic demographic data like age, duration of disease, and modified Rodnan skin score', 'patients with diffuse scleroderma', 'Patients with Systemic Sclerosis', '25 patients with diffuse SSc without lung involvement on primary chest high-resolution computed tomography', '13 patients and 1200 milligram NAC for 12 patients']","['Placebo', 'NAC', 'N-acetylcysteine (NAC), thiol-containing compound', 'N-acetylcysteine', 'placebo']","['Body plethysmography parameters', 'Pulmonary Functions', 'interstitial lung disease, DLCO', 'changes of DLCO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205198', 'cui_str': 'Compound'}]","[{'cui': 'C0032224', 'cui_str': 'Total body plethysmography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",25.0,0.306015,The analysis showed no significant differences in parameters of plethysmography between the two groups.,"[{'ForeName': 'Samrad', 'Initials': 'S', 'LastName': 'Mehrabi', 'Affiliation': 'Division of Pulmonology, Department of Internal Medicine, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam M', 'Initials': 'MM', 'LastName': 'Moradi', 'Affiliation': 'Department of Internal Medicine, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Khodamoradi', 'Affiliation': 'Student Research Committee, Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad A', 'Initials': 'MA', 'LastName': 'Nazarinia', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Current rheumatology reviews,['10.2174/1573397115666191212092608']
2509,31836261,In the eye of the beholder? Oxytocin effects on eye movements in schizophrenia.,"BACKGROUND


Individuals with schizophrenia have difficulty in extracting salient information from faces. Eye-tracking studies have reported that these individuals demonstrate reduced exploratory viewing behaviour (i.e. reduced number of fixations and shorter scan paths) compared to healthy controls. Oxytocin has previously been demonstrated to exert pro-social effects and modulate eye gaze during face exploration. In this study, we tested whether oxytocin has an effect on visual attention in patients with schizophrenia.
METHODS


Nineteen male participants with schizophrenia received intranasal oxytocin 40UI or placebo in a double-blind, placebo-controlled, crossover fashion during two visits separated by seven days. They engaged in a free-viewing eye-tracking task, exploring images of Caucasian men displaying angry, happy, and neutral emotional expressions; and control images of animate and inanimate stimuli. Eye-tracking parameters included: total number of fixations, mean duration of fixations, dispersion, and saccade amplitudes.
RESULTS


We found a main effect of treatment, whereby oxytocin increased the total number of fixations, dispersion, and saccade amplitudes, while decreasing the duration of fixations compared to placebo. This effect, however, was non-specific to facial stimuli. When restricting the analysis to facial images only, we found the same effect. In addition, oxytocin modulated fixation rates in the eye and nasion regions.
DISCUSSION


This is the first study to explore the effects of oxytocin on eye gaze in schizophrenia. Oxytocin had enhanced exploratory viewing behaviour in response to both facial and inanimate control stimuli. We suggest that the acute administration of intranasal oxytocin may have the potential to enhance visual attention in schizophrenia.",2020,"We found a main effect of treatment, whereby oxytocin increased the total number of fixations, dispersion, and saccade amplitudes, while decreasing the duration of fixations compared to placebo.","['patients with schizophrenia', 'Nineteen male participants with schizophrenia received', 'schizophrenia']","['oxytocin', 'intranasal oxytocin', 'intranasal oxytocin 40UI or placebo', 'Oxytocin', 'placebo']","['fixation rates', 'total number of fixations, dispersion, and saccade amplitudes', 'total number of fixations, mean duration of fixations, dispersion, and saccade amplitudes', 'visual attention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0036019', 'cui_str': 'Saccadic eye movement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}]",19.0,0.185774,"We found a main effect of treatment, whereby oxytocin increased the total number of fixations, dispersion, and saccade amplitudes, while decreasing the duration of fixations compared to placebo.","[{'ForeName': 'Lilla A', 'Initials': 'LA', 'LastName': 'Porffy', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. Electronic address: lilla.a.porffy@kcl.ac.uk.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Bell', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Coutrot', 'Affiliation': 'Laboratoire des Sciences du Numérique de Nantes, CNRS, Université de Nantes, Nantes, France.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Wigton', 'Affiliation': 'Department of Neurology, Harvard Medical School, Boston, MA, USA; Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': ""D'Oliveira"", 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Mareschal', 'Affiliation': 'Biological and Experimental Psychology, School of Biological and Chemical Sciences, Queen Mary University, London, UK.'}, {'ForeName': 'Sukhwinder S', 'Initials': 'SS', 'LastName': 'Shergill', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}]",Schizophrenia research,['10.1016/j.schres.2019.11.044']
2510,30649049,Long-term effects of unintended pregnancy on antiretroviral therapy outcomes among South African women living with HIV.,"OBJECTIVE


Unintended pregnancies are common among women living with HIV, but there are no data on their long-term impact on treatment outcomes. In a cohort of women initiating antiretroviral therapy (ART) during pregnancy, we examined the association between the intendedness of the current pregnancy, measured antenatally, and elevated viral load up to 5 years postpartum.
DESIGN


Prospective study with enrolment at entry into antenatal care and follow-up at study visits separate from routine care.
METHODS


At enrolment women completed the London Measure of Unplanned Pregnancy. Mixed effects models examined the impact of the intendedness of the pregnancy (planned versus each of unplanned or ambivalent, respectively) on viral load 50 or more copies/ml across postpartum study visits.
RESULTS


Overall, 459 women were followed for a median of 43 months postpartum, contributing 2535 viral load measures (median per woman: 6). Ambivalent and unplanned pregnancy were commonly reported (20 and 60%, respectively), and the proportion of women with elevated viral load increased over time (16% at 6 weeks to 43% by 36-60 months postpartum). Compared with those reporting a planned pregnancy, elevated viral load was more common among women reporting an unplanned pregnancy (odds ratio: 2.87; 95% confidence interval: 1.46-5.64), with a trend towards a higher odds among those reporting ambivalence (odds ratio: 2.19; 95% confidence interval: 0.97-4.82); associations persisted after adjustment for a wide range of demographic, clinical and psychosocial factors.
CONCLUSION


These novel data suggest that unplanned pregnancy may be a prevalent and persistent predictor of poor ART outcomes among women initiating ART during pregnancy.",2019,"Compared with those reporting a planned pregnancy, elevated viral load was more common among women reporting an unplanned pregnancy (odds ratio: 2.87; 95% confidence interval: 1.46-5.64), with a trend towards a higher odds among those reporting ambivalence (odds ratio: 2.19; 95% confidence interval: 0.97-4.82); associations persisted after adjustment for a wide range of demographic, clinical and psychosocial factors.
","['459 women', 'Prospective study with enrolment at entry into antenatal care and follow-up at study visits separate from routine care', 'South African women living with HIV', 'women living with HIV']",['unintended pregnancy'],"['London Measure of Unplanned Pregnancy', 'Ambivalent and unplanned pregnancy', 'proportion of women with elevated viral load']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0041747', 'cui_str': 'Unplanned pregnancy'}]","[{'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0041747', 'cui_str': 'Unplanned pregnancy'}, {'cui': 'C0233495', 'cui_str': 'Feeling mixed emotions'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",2535.0,0.322241,"Compared with those reporting a planned pregnancy, elevated viral load was more common among women reporting an unplanned pregnancy (odds ratio: 2.87; 95% confidence interval: 1.46-5.64), with a trend towards a higher odds among those reporting ambivalence (odds ratio: 2.19; 95% confidence interval: 0.97-4.82); associations persisted after adjustment for a wide range of demographic, clinical and psychosocial factors.
","[{'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Brittain', 'Affiliation': 'Division of Epidemiology & Biostatistics, and.'}, {'ForeName': 'Tamsin K', 'Initials': 'TK', 'LastName': 'Phillips', 'Affiliation': 'Division of Epidemiology & Biostatistics, and.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Zerbe', 'Affiliation': 'ICAP, Mailman School of Public Health.'}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Abrams', 'Affiliation': 'ICAP, Mailman School of Public Health.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology & Biostatistics, and.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002139']
2511,31865852,A Short-Duration Combined Exercise and Education Program to Improve Physical Function and Social Engagement in Community-Dwelling Elderly Adults.,"Exercise is a key intervention for improving older adults' physical function and life expectancy. Here, we investigated a short-term intervention program designed to improve the physical functioning of elderly adults in a community-dwelling setting. We examined the effect of a 5-week combined exercise and education program on the physical function, social engagement, mobility performance, and fear of falling in 42 subjects older than 65 years. Eleven subjects dropped out. There was significant improvement in the 30-second chair stand test ( p  < .001) and timed up-and-go test ( p  < .001) between the baseline and the last session. At the end of the intervention, the subjects' social engagement was significantly higher than at baseline ( p  = .022), but this improvement was not maintained in the follow-up assessment. These results suggest that a combined exercise and education program can improve the physical function and social engagement of elderly individuals living in a community dwelling.",2020,There was significant improvement in the 30-second chair stand test ( p  < .001) and timed up-and-go test ( p  < .001) between the baseline and the last session.,"['42 subjects older than 65\u2009years', 'Eleven subjects dropped out', 'older adults', 'elderly adults in a community-dwelling setting', 'elderly individuals living in a community dwelling', 'Community-Dwelling Elderly Adults']","['Exercise', 'combined exercise and education program', 'Short-Duration Combined Exercise and Education Program']","['physical function, social engagement, mobility performance, and fear of falling', 'physical function and social engagement', 'Physical Function and Social Engagement', 'physical function and life expectancy', ""subjects' social engagement"", '30-second chair stand test']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0557143', 'cui_str': 'Lives in a community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.013307,There was significant improvement in the 30-second chair stand test ( p  < .001) and timed up-and-go test ( p  < .001) between the baseline and the last session.,"[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Physical Therapy, School of Healthcare, Ibaraki Prefectural University of Health Sciences, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ishii', 'Affiliation': 'Center for Medical Sciences, Ibaraki Prefectural University of Health Sciences, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Noguchi', 'Affiliation': 'Sakai Neurosurgical Clinic, Japan.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Tanamachi', 'Affiliation': 'Department of Rehabilitation, University of Tsukuba Hospital, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Department of Occupational Therapy, School of Healthcare, Ibaraki Prefectural University of Health Sciences, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Takasaki', 'Affiliation': 'Department of Rehabilitation, Ibaraki Prefectural University of Health Sciences Hospital, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Miyata', 'Affiliation': 'Department of Physical Therapy, School of Healthcare, Ibaraki Prefectural University of Health Sciences, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Department of Rehabilitation, Ibaraki Prefectural University of Health Sciences Hospital, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Rehabilitation, University of Tsukuba Hospital, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Department of Rehabilitation, Ibaraki Prefectural University of Health Sciences Hospital, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Iwai', 'Affiliation': 'Center for Humanities and Sciences, Ibaraki Prefectural University of Health Sciences, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kohno', 'Affiliation': 'Center for Medical Sciences, Ibaraki Prefectural University of Health Sciences, Japan.'}]",International quarterly of community health education,['10.1177/0272684X19896732']
2512,21310539,Examining the effect of the Life Enhancement Treatment for Substance Use (LETS ACT) on residential substance abuse treatment retention.,"Effective, parsimonious behavioral interventions that target reinforcement are needed for substance users with depression to improve mood as well as treatment retention. The Life Enhancement Treatment for Substance Use (LETS ACT; Daughters et al., 2008) is a behavioral activation-based approach tailored to increase levels of positive reinforcement among depressed substance users while in substance abuse treatment. The current study tested the efficacy of LETS ACT compared to a contact-time matched control condition, supportive counseling (SC), examining effects on depressed mood, substance abuse treatment retention, and behavioral activation outcomes. Fifty-eight adult substance users in residential substance abuse treatment presenting with depressive symptoms (BDI≥12) were randomly assigned to LETS ACT or SC. Assessments were administered at pre- and post-treatment and included assessment of DSM-IV psychiatric diagnoses, depression severity, treatment motivation, overall activation, environmental reward, and substance abuse treatment retention. Patients in LETS ACT had significantly higher rates of substance abuse treatment retention and significantly greater increases in activation on the Behavioral Activation for Depression Scale (BADS) compared to those in SC. Both groups had decreased depression severity at post-treatment, although the group by time interaction was not significant. This study was the first to compare LETS ACT to a contact-time matched control treatment to evaluate effects on substance abuse treatment retention and two distinct measures of behavioral activation: overall activation and environmental reward. Findings suggest preliminary support for the feasibility, tolerability, and efficacy of a brief behavioral activation-based protocol that may be particularly useful to improve substance abuse treatment retention.",2011,Patients in LETS ACT had significantly higher rates of substance abuse treatment retention and significantly greater increases in activation on the Behavioral Activation for Depression Scale (BADS) compared to those in SC.,"['Fifty-eight adult substance users in residential substance abuse treatment presenting with depressive symptoms (BDI≥12', 'residential substance abuse treatment retention']","['Life Enhancement Treatment for Substance Use (LETS ACT', 'LETS ACT', 'LETS ACT or SC']","['rates of substance abuse treatment retention', 'DSM-IV psychiatric diagnoses, depression severity, treatment motivation, overall activation, environmental reward, and substance abuse treatment retention', 'Behavioral Activation for Depression Scale (BADS', 'depression severity']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0338666', 'cui_str': 'Drug Users'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]","[{'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0376338', 'cui_str': 'Diagnosis, Psychiatric'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0222045'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]",,0.0236054,Patients in LETS ACT had significantly higher rates of substance abuse treatment retention and significantly greater increases in activation on the Behavioral Activation for Depression Scale (BADS) compared to those in SC.,"[{'ForeName': 'Jessica F', 'Initials': 'JF', 'LastName': 'Magidson', 'Affiliation': 'Department of Behavioral and Community Health, School of Public Health, University of Maryland, College Park, College Park, MD 20742, United States; Center for Addictions, Personality, and Emotion Research (CAPER), Psychology Department, University of Maryland, College Park, College Park, MD 20742, United States. Electronic address: jmagidson@psyc.umd.edu.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gorka', 'Affiliation': 'Department of Behavioral and Community Health, School of Public Health, University of Maryland, College Park, College Park, MD 20742, United States. Electronic address: sgorka@umd.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'MacPherson', 'Affiliation': 'Center for Addictions, Personality, and Emotion Research (CAPER), Psychology Department, University of Maryland, College Park, College Park, MD 20742, United States. Electronic address: lmacpherson@psyc.umd.edu.'}, {'ForeName': 'Derek R', 'Initials': 'DR', 'LastName': 'Hopko', 'Affiliation': 'University of Tennessee, Department of Psychology, Room 301D, Austin Peay Building, Knoxville, TN 37996, United States. Electronic address: dhopko@utk.edu.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Blanco', 'Affiliation': 'Department of Psychiatry, Columbia University, 1051 Riverside Drive, New York, NY 10032, United States. Electronic address: cb255@columbia.edu.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Lejuez', 'Affiliation': 'Center for Addictions, Personality, and Emotion Research (CAPER), Psychology Department, University of Maryland, College Park, College Park, MD 20742, United States. Electronic address: clejuez@psyc.umd.edu.'}, {'ForeName': 'Stacey B', 'Initials': 'SB', 'LastName': 'Daughters', 'Affiliation': 'Department of Behavioral and Community Health, School of Public Health, University of Maryland, College Park, College Park, MD 20742, United States. Electronic address: daughter@umd.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2011.01.016']
2513,30755129,Predicting Engagement With Mental Health Peer Specialist Services.,"OBJECTIVE


Peer specialists are individuals with behavioral disorders who complete training to use their experiences to help others with similar disorders. Recent analyses have suggested that greater engagement with peer specialist services is associated with fewer psychiatric symptoms. This study assessed predictors of engagement with peer specialist services.
METHODS


Using the Andersen model of health service utilization with a sample of veterans (N=71) receiving housing support, investigators constructed a negative binomial regression model to evaluate the association between peer specialist service engagement and the model's three factors assessed at baseline of a larger trial: predisposing (personal demographic and social variables); enabling (support variables), and need (perceived and evaluated health problems). Demographic characteristics and behavioral health service use six months before baseline were also predictors.
RESULTS


Greater hope (predisposing), psychiatric symptoms (need), and service utilization significantly predicted greater peer specialist engagement.
CONCLUSIONS


These results suggest subpopulations with whom peer specialists would be most likely to engage successfully, perhaps improving their efficiency.",2019,"Greater hope (predisposing), psychiatric symptoms (need), and service utilization significantly predicted greater peer specialist engagement.
","['health service utilization with a sample of veterans (N=71) receiving', 'individuals with behavioral disorders who complete training to use their experiences to help others with similar disorders']",['housing support'],"['Greater hope (predisposing), psychiatric symptoms (need), and service utilization']","[{'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004930', 'cui_str': 'Behaviour disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205394', 'cui_str': 'Other'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}]",,0.0292295,"Greater hope (predisposing), psychiatric symptoms (need), and service utilization significantly predicted greater peer specialist engagement.
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Chinman', 'Affiliation': 'Center for Health Equity Research and Promotion and the Mental Illness Research, Education, and Clinical Center (Chinman, Mitchell-Miland, Bachrach) and Department of Health Science (McCarthy), Veterans Affairs (VA) Pittsburgh Healthcare System, Pittsburgh; Department of Health, RAND Corporation, Santa Monica, California (Chinman); Department of Sociology (Schutt) and Department of Psychiatry (Ellison), University of Massachusetts, Boston.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'McCarthy', 'Affiliation': 'Center for Health Equity Research and Promotion and the Mental Illness Research, Education, and Clinical Center (Chinman, Mitchell-Miland, Bachrach) and Department of Health Science (McCarthy), Veterans Affairs (VA) Pittsburgh Healthcare System, Pittsburgh; Department of Health, RAND Corporation, Santa Monica, California (Chinman); Department of Sociology (Schutt) and Department of Psychiatry (Ellison), University of Massachusetts, Boston.'}, {'ForeName': 'Chantele', 'Initials': 'C', 'LastName': 'Mitchell-Miland', 'Affiliation': 'Center for Health Equity Research and Promotion and the Mental Illness Research, Education, and Clinical Center (Chinman, Mitchell-Miland, Bachrach) and Department of Health Science (McCarthy), Veterans Affairs (VA) Pittsburgh Healthcare System, Pittsburgh; Department of Health, RAND Corporation, Santa Monica, California (Chinman); Department of Sociology (Schutt) and Department of Psychiatry (Ellison), University of Massachusetts, Boston.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Bachrach', 'Affiliation': 'Center for Health Equity Research and Promotion and the Mental Illness Research, Education, and Clinical Center (Chinman, Mitchell-Miland, Bachrach) and Department of Health Science (McCarthy), Veterans Affairs (VA) Pittsburgh Healthcare System, Pittsburgh; Department of Health, RAND Corporation, Santa Monica, California (Chinman); Department of Sociology (Schutt) and Department of Psychiatry (Ellison), University of Massachusetts, Boston.'}, {'ForeName': 'Russell K', 'Initials': 'RK', 'LastName': 'Schutt', 'Affiliation': 'Center for Health Equity Research and Promotion and the Mental Illness Research, Education, and Clinical Center (Chinman, Mitchell-Miland, Bachrach) and Department of Health Science (McCarthy), Veterans Affairs (VA) Pittsburgh Healthcare System, Pittsburgh; Department of Health, RAND Corporation, Santa Monica, California (Chinman); Department of Sociology (Schutt) and Department of Psychiatry (Ellison), University of Massachusetts, Boston.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Ellison', 'Affiliation': 'Center for Health Equity Research and Promotion and the Mental Illness Research, Education, and Clinical Center (Chinman, Mitchell-Miland, Bachrach) and Department of Health Science (McCarthy), Veterans Affairs (VA) Pittsburgh Healthcare System, Pittsburgh; Department of Health, RAND Corporation, Santa Monica, California (Chinman); Department of Sociology (Schutt) and Department of Psychiatry (Ellison), University of Massachusetts, Boston.'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201800368']
2514,31028232,Probability of cancer in lung nodules using sequential volumetric screening up to 12 months: the UKLS trial.,"BACKGROUND


Estimation of the clinical probability of malignancy in patients with pulmonary nodules will facilitate early diagnosis, determine optimum patient management strategies and reduce overall costs.
METHODS


Data from the UK Lung Cancer Screening trial were analysed. Multivariable logistic regression models were used to identify independent predictors and to develop a parsimonious model to estimate the probability of lung cancer in lung nodules detected at baseline and at 3-month and 12-month repeat screening.
RESULTS


Of 1994 participants who underwent CT scan, 1013 participants had a total of 5063 lung nodules and 52 (2.6%) of the participants developed lung cancer during a median follow-up of 4 years. Covariates that predict lung cancer in our model included female gender, asthma, bronchitis, asbestos exposure, history of cancer, early and late onset of family history of lung cancer, smoking duration, FVC, nodule type (pure ground-glass and part-solid) and volume as measured by semiautomated volumetry. The final model incorporating all predictors had excellent discrimination: area under the receiver operating characteristic curve (AUC 0.885, 95% CI 0.880 to 0.889). Internal validation suggested that the model will discriminate well when applied to new data (optimism-corrected AUC 0.882, 95% CI 0.848 to 0.907). The risk model had a good calibration (goodness-of-fit χ[8] 8.13, p=0.42).
CONCLUSIONS


Our model may be used in estimating the probability of lung cancer in nodules detected at baseline and at 3 months and 12 months from baseline, allowing more efficient stratification of follow-up in population-based lung cancer screening programmes.
TRIAL REGISTRATION NUMBER


78513845.",2019,"The final model incorporating all predictors had excellent discrimination: area under the receiver operating characteristic curve (AUC 0.885, 95% CI 0.880 to 0.889).","['1994 participants who underwent', '1013 participants had a total of 5063 lung nodules and 52 (2.6%) of the participants developed lung cancer during a median follow-up of 4 years', 'Data from the UK Lung Cancer Screening trial', 'patients with pulmonary nodules']","['CT scan', 'sequential volumetric screening']",['probability of lung cancer in lung nodules'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034079', 'cui_str': 'Nodule of lung'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0034079', 'cui_str': 'Nodule of lung'}]",,0.0545704,"The final model incorporating all predictors had excellent discrimination: area under the receiver operating characteristic curve (AUC 0.885, 95% CI 0.880 to 0.889).","[{'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Marcus', 'Affiliation': 'Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK J.K.Field@liverpool.ac.uk m.w.marcus@liv.ac.uk.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Barts and London, Wolfson Institute of Preventive Medicine, London, UK.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Devaraj', 'Affiliation': 'Department of Radiology, Royal Brompton Hospital London, London, UK.'}, {'ForeName': 'Beverley A', 'Initials': 'BA', 'LastName': 'Green', 'Affiliation': 'Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Oudkerk', 'Affiliation': 'Center for Medical Imaging (CMI), University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baldwin', 'Affiliation': 'Nottingham University Hospitals, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Field', 'Affiliation': 'Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK J.K.Field@liverpool.ac.uk m.w.marcus@liv.ac.uk.'}]",Thorax,['10.1136/thoraxjnl-2018-212263']
2515,21342456,Developmental outcomes among 18-month-old Malawians after a year of complementary feeding with lipid-based nutrient supplements or corn-soy flour.,"The major aim of this trial was to compare the development of 18-month-old infants who received complementary feeding for 1 year either with lipid-based nutrient supplements or micronutrient fortified corn-soy porridge. Our secondary aim was to determine the socio-economic factors associated with developmental outcomes in the same population. A total of 163 six-month-old rural Malawian children were enrolled in a randomized controlled trial where the control population received daily supplementation with 71 g corn-soy flour [Likuni Phala (LP)] (282 kcal) and individuals in the intervention groups received daily either 50 g of lipid-based nutrient supplement (FS50) (264 kcal) or 25 g of lipid-based nutrient supplement (FS25) (130 kcal). The main outcome measures were Griffiths' developmental scores at 0-2 years. Independent comparison of study groups was carried out using analysis of variance (ANOVA) statistics where mean raw scores, quotients, or mental ages were compared. Association of developmental outcome with predictor variables were examined using multiple regression. At 18 months of chronological age, the mean ± standard deviation (SD) mental ages in the LP, FS50, and FS25 groups were 17.9 ± 1.3, 17.9 ± 1.3, and 17.9 ± 1.2 (P > 0.99), respectively. Likewise, the mean raw developmental scores and mean developmental quotients did not differ significantly. Length-for-age z-score gain during the intervention period, and maternal education were associated with developmental outcome at 18 months (P = 0.03 and P = 0.04; respectively). In conclusion, rural Malawian infants receiving 12-month daily supplementation of their diet either with the tested lipid-based nutrient supplements or fortified corn-soy flour have comparable development outcomes by 18 months of age.",2012,"Likewise, the mean raw developmental scores and mean developmental quotients did not differ significantly.","['18-month-old infants who received complementary feeding for 1 year either with', 'A total of 163 six-month-old rural Malawian children', 'rural Malawian infants']","['daily either 50 g of lipid-based nutrient supplement (FS50) (264 kcal) or 25 g of lipid-based nutrient supplement (FS25', 'lipid-based nutrient supplements or micronutrient fortified corn-soy porridge', 'daily supplementation with 71 g corn-soy flour [Likuni Phala (LP', 'lipid-based nutrient supplements or corn-soy flour']","['Length-for-age z-score gain', ""Griffiths' developmental scores"", 'mean raw developmental scores and mean developmental quotients']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0456638', 'cui_str': '25G (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0452575', 'cui_str': 'Porridge (substance)'}, {'cui': 'C0771806', 'cui_str': 'Soya flour (substance)'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0579308,"Likewise, the mean raw developmental scores and mean developmental quotients did not differ significantly.","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Phuka', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi. johnphuka@yahoo.co.uk'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Gladstone', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': ''}, {'ForeName': 'Chrissie', 'Initials': 'C', 'LastName': 'Thakwalakwa', 'Affiliation': ''}, {'ForeName': 'Yin Bun', 'Initials': 'YB', 'LastName': 'Cheung', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Briend', 'Affiliation': ''}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Manary', 'Affiliation': ''}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2011.00294.x']
2516,21316157,Electronic screening and brief intervention for risky drinking in Swedish university students--a randomized controlled trial.,"BACKGROUND


The limited number of electronic screening and brief intervention (e-SBI) projects taking place in young adult student populations has left knowledge gaps about the specific methods needed to motivate reduced drinking. The aim of the present study was to compare differences in alcohol consumption over time after a series of e-SBIs was conducted with two groups of young adult students who were considered risky drinkers. The intervention group (IG) (n=80) received extensive normative feedback; the control group (CG) (n=78) received very brief feedback consisting of only three statements.
METHOD


An e-SBI project was conducted in naturalistic settings among young adult students at a Swedish university. This study used a randomized controlled trial design, with respondents having an equal chance of being assigned to either the IG or the CG. The study assessed changes comparing the IG with the CG on four alcohol-related measurements: proportion with risky alcohol consumption, average weekly alcohol consumption, frequency of heavy episodic drinking (HED) and peak blood alcohol concentration (BAC). Follow-up was performed at 3 and 6 months after baseline.
RESULTS


The study documented a significant decrease in the average weekly consumption for the IG over time but not for the CG, although the differences between the groups were non-significant. The study also found that there were significant decreases in HED over time within both groups; the differences were about equal in both groups at the 6-month follow-up. The proportion of risky drinkers decreased by about a third in both the CG and IG at the 3- and 6-month follow-ups.
CONCLUSIONS


As the differences between the groups at 6 months for all alcohol-related outcome variables were not significant, the shorter, generic brief intervention appears to be as effective as the longer one including normative feedback. However, further studies in similar naturalistic settings are warranted with delayed assessment groups as controls in order to increase our understanding of reactivity assessment in email-based interventions among students.",2011,"As the differences between the groups at 6 months for all alcohol-related outcome variables were not significant, the shorter, generic brief intervention appears to be as effective as the longer one including normative feedback.","['young adult students at a Swedish university', 'young adult student populations', 'risky drinking in Swedish university students', 'young adult students who were considered risky drinkers', 'respondents having an equal chance of being assigned to either the IG or the CG']","['Electronic screening and brief intervention', 'extensive normative feedback; the control group (CG) (n=78) received very brief feedback consisting of only three statements']","['average weekly consumption', 'HED', 'risky alcohol consumption, average weekly alcohol consumption, frequency of heavy episodic drinking (HED) and peak blood alcohol concentration (BAC', 'proportion of risky drinkers']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}, {'cui': 'C0887889', 'cui_str': 'BACs (Chromosomes)'}]",,0.0197575,"As the differences between the groups at 6 months for all alcohol-related outcome variables were not significant, the shorter, generic brief intervention appears to be as effective as the longer one including normative feedback.","[{'ForeName': 'Diana Stark', 'Initials': 'DS', 'LastName': 'Ekman', 'Affiliation': 'Division of Social Medicine and Public Health Science, Department of Medical and Health Sciences (IMH), Linköping University, SE-581 83, Linköping, Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Andersson', 'Affiliation': 'Division of Social Medicine and Public Health Science, Department of Medical and Health Sciences (IMH), Linköping University, SE-581 83, Linköping, Sweden; Local Health Care Research and Development Unit, County Council in Östergötland, SE-581 85 Linköping, Sweden. Electronic address: agneta.g.andersson@lio.se.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nilsen', 'Affiliation': 'Division of Social Medicine and Public Health Science, Department of Medical and Health Sciences (IMH), Linköping University, SE-581 83, Linköping, Sweden. Electronic address: per.nilsen@liu.se.'}, {'ForeName': 'Henriettae', 'Initials': 'H', 'LastName': 'Ståhlbrandt', 'Affiliation': 'Division of Social Medicine and Public Health Science, Department of Medical and Health Sciences (IMH), Linköping University, SE-581 83, Linköping, Sweden. Electronic address: henrietta.stahlbrandt@med.lu.se.'}, {'ForeName': 'Anne Lie', 'Initials': 'AL', 'LastName': 'Johansson', 'Affiliation': 'Division of Social Medicine and Public Health Science, Department of Medical and Health Sciences (IMH), Linköping University, SE-581 83, Linköping, Sweden. Electronic address: anne.lie.johansson@liu.se.'}, {'ForeName': 'Preben', 'Initials': 'P', 'LastName': 'Bendtsen', 'Affiliation': 'Division of Social Medicine and Public Health Science, Department of Medical and Health Sciences (IMH), Linköping University, SE-581 83, Linköping, Sweden. Electronic address: preben.bendtsen@liu.se.'}]",Addictive behaviors,['10.1016/j.addbeh.2011.01.015']
2517,32423937,"Effectiveness and acceptability of metformin in preventing the onset of type 2 diabetes after gestational diabetes in postnatal women: a protocol for a randomised, placebo-controlled, double-blind feasibility trialOptimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA).","INTRODUCTION


Up to half of all women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5 years after delivery. Metformin is effective in preventing type 2 diabetes in high-risk non-pregnant individuals, but its effect when commenced in the postnatal period is not known. We plan to assess the feasibility of evaluating metformin versus placebo in minimising the risk of dysglycaemia including type 2 diabetes after delivery in postnatal women with a history of gestational diabetes through a randomised trial.
METHODS AND ANALYSIS


Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA) is a multicentre placebo-controlled double-blind randomised feasibility trial, where we will randomly allocate 160 postnatal women with gestational diabetes treated with medication to either metformin (intervention) or placebo (control) tablets to be taken until 1 year after delivery. The primary outcomes are rates of recruitment, randomisation, adherence and attrition. The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study. Feasibility outcomes will be summarised using descriptive statistics, point estimates and 95% CIs.
ETHICS AND DISSEMINATION


The OMAhA study received ethics approval from the London-Brent Research Ethics Committee (18/LO/0505). Trial findings will be published in a peer-reviewed journal, disseminated at conferences, through our Patient and Public Involvement advisory group (Katie's Team) and through social media platforms.
TRIAL REGISTRATION NUMBER


ISRCTN20930880.",2020,"The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study.","['women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5\u2009years after delivery', 'type 2 diabetes after gestational diabetes in postnatal women', '160 postnatal women with gestational diabetes treated with medication to either', 'diAbetes After pregnancy (OMAhA', 'to prevent diAbetes After pregnancy', 'postnatal women with a history of gestational diabetes']","['Metformin', 'metformin versus placebo', 'metformin', 'metformin (intervention) or placebo (control) tablets', 'placebo']","['maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention', 'rates of recruitment, randomisation, adherence and attrition', 'Effectiveness and acceptability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",160.0,0.592804,"The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study.","[{'ForeName': 'Chiamaka Esther', 'Initials': 'CE', 'LastName': 'Amaefule', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK c.e.amaefule@qmul.ac.uk.""}, {'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Bolou', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Drymoussi', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Francisco Jose', 'Initials': 'FJ', 'LastName': 'Gonzalez Carreras', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Maria Del Carmen', 'Initials': 'MDC', 'LastName': 'Pardo Llorente', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Lanz', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dodds', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Sweeney', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pizzo', 'Affiliation': 'Collaborations for Leadership in Applied Health Research and Care (CLAHRC) for North Thames London, Department of Applied Health Research, University College London, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""D'Amico"", 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Heighway', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Jahnavi', 'Initials': 'J', 'LastName': 'Daru', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Soha', 'Initials': 'S', 'LastName': 'Sobhy', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Robson', 'Affiliation': 'Clinical Effectiveness Group, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Sanghi', 'Affiliation': ""Women's Division, Royal London Hospital, Barts Health NHS Trust, London, UK.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': 'Clinical Biostatistics Unit (IRYCIS) and CIBER Epidemiology and Public Health, Ramon y Cajal University Hospital, Madrid, Spain.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Harden', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Hitman', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Khan', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Pérez', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Mohammed Sb', 'Initials': 'MS', 'LastName': 'Huda', 'Affiliation': 'Department of Diabetes and Metabolism, Barts Health NHS Trust, Royal London Hospital, London, UK.'}, {'ForeName': 'Shakila', 'Initials': 'S', 'LastName': 'Thangaratinam', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2019-036198']
2518,21324607,Motivation to change alcohol use and treatment engagement in incarcerated youth.,"Adolescents have been reported to be less motivated to engage and remain in substance abuse treatment than adults. When they appear motivated, it is often due to external motivators such as family pressure or court mandated treatment. The purpose of this study was to determine if adolescents' motivation to change alcohol use was related to treatment engagement while incarcerated and alcohol use after release. Participants (N=114) were youth in a state correctional facility in the Northeast and included adolescents who engaged in at least monthly drinking. Motivation to change alcohol use was measured by the Alcohol Ladder (AL), and treatment engagement was measured by the Treatment Participation Questionnaire (comprised of positive and negative treatment engagement). Measures were administered at baseline, 2 months in facility follow up, and 3 months post release follow up. Analysis indicated acceptable test-retest stability (r=.388, p≤.001). The AL at 3 months post release significantly predicted quantity and frequency of alcohol use after release. The AL at baseline also significantly predicted positive and negative treatment engagement at 2 months into incarceration (i.e., 2 months in facility follow up) indicating predictive validity. These results suggest that the AL is a reliable, valid, and useful instrument for incarcerated youth.",2011,"The AL at baseline also significantly predicted positive and negative treatment engagement at 2 months into incarceration (i.e., 2 months in facility follow up) indicating predictive validity.","['incarcerated youth', 'Participants (N=114) were youth in a state correctional facility in the Northeast and included adolescents who engaged in at least monthly drinking']",[],"['acceptable test-retest stability', 'Alcohol Ladder (AL), and treatment engagement']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0442681', 'cui_str': 'Penal institution (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",[],"[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0336762', 'cui_str': 'Ladder, device (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",114.0,0.0177492,"The AL at baseline also significantly predicted positive and negative treatment engagement at 2 months into incarceration (i.e., 2 months in facility follow up) indicating predictive validity.","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Clair', 'Affiliation': 'Rhode Island Training School, 300 New London Avenue, Cranston, RI, 02920, United States; University of Rhode Island, 2 Chafee Road, Kingston, RI 02881, United States. Electronic address: mclair@uri.edu.'}, {'ForeName': 'L A R', 'Initials': 'LAR', 'LastName': 'Stein', 'Affiliation': 'Center for Alcohol and Addictions Studies, Brown University, 121 South Main Street, Providence, RI 02903, United States; Rhode Island Training School, 300 New London Avenue, Cranston, RI, 02920, United States; University of Rhode Island, 2 Chafee Road, Kingston, RI 02881, United States.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Center for Alcohol and Addictions Studies, Brown University, 121 South Main Street, Providence, RI 02903, United States.'}, {'ForeName': 'Nancy P', 'Initials': 'NP', 'LastName': 'Barnett', 'Affiliation': 'Center for Alcohol and Addictions Studies, Brown University, 121 South Main Street, Providence, RI 02903, United States.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol and Addictions Studies, Brown University, 121 South Main Street, Providence, RI 02903, United States.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Monti', 'Affiliation': 'Center for Alcohol and Addictions Studies, Brown University, 121 South Main Street, Providence, RI 02903, United States; Veterans Administration Medical Center, 830 Chalkstone Avenue, Providence, RI 02908, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Golembeske', 'Affiliation': 'Center for Alcohol and Addictions Studies, Brown University, 121 South Main Street, Providence, RI 02903, United States; Rhode Island Training School, 300 New London Avenue, Cranston, RI, 02920, United States; University of Rhode Island, 2 Chafee Road, Kingston, RI 02881, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lebeau', 'Affiliation': 'University of Rhode Island, 2 Chafee Road, Kingston, RI 02881, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2011.01.007']
2519,21480203,Feasibility of an expressive-disclosure group intervention for post-treatment colorectal cancer patients: results of the Healthy Expressions study.,"BACKGROUND


Adjusting to cancer requires effective cognitive and emotional processing. Written and verbal disclosure facilitate processing and have been studied independently in cancer survivors. Combined written and verbal expression may be more effective than either alone, particularly for patients with difficult to discuss or embarrassing side effects. Thus, the authors developed and tested the efficacy of a 12-session combined written and verbal expression group program for psychologically distressed colorectal cancer (CRC) patients.
METHODS


Forty post-treatment patients with CRC (stages I-III) identified as psychologically distressed using the Brief Symptom Inventory (BSI) were randomized to an intervention group (Healthy Expressions; n = 25) or standard care (control group; n = 15). Assessments were completed at baseline, Month 2, and Month 4 (postintervention). Primary outcomes were psychological functioning and quality of life (QOL).
RESULTS


Most participants were women (63%), white (63%), and non-Hispanic (75%). The Healthy Expressions group demonstrated significantly greater changes in distress compared with the control group at Month 2 on the BSI Global Severity Index (GSI) and the Centers for Epidemiologic Studies Depression scale (CES-D) scores (P < .05 for each); differences in the European Organization for Research and Treatment of Cancer (EORTC) global QOL scores approached significance (P = .063). The BSI GSI and Positive Symptom Total, CES-D, and EORTC emotional functioning subscale scores were all significant at Month 4 (P < .05 for each).
CONCLUSIONS


The Healthy Expressions program improved psychological functioning in CRC patients who reported experiencing distress. Findings demonstrate the program's feasibility and provide strong support for conducting a larger randomized trial.",2011,The Healthy Expressions group demonstrated significantly greater changes in distress compared with the control group at Month 2 on the BSI Global Severity Index (GSI) and the Centers for Epidemiologic Studies Depression scale (CES-D) scores (P < .05 for each); differences in the European Organization for Research and Treatment of Cancer (EORTC) global QOL scores approached significance (P = .063).,"['Most participants were women (63%), white (63%), and non-Hispanic (75', 'post-treatment colorectal cancer patients', 'Forty post-treatment patients with CRC (stages I-III) identified as psychologically distressed using the Brief Symptom Inventory (BSI', 'psychologically distressed colorectal cancer (CRC) patients', 'CRC patients who reported experiencing distress']","['12-session combined written and verbal expression group program', 'intervention group (Healthy Expressions; n = 25) or standard care', 'expressive-disclosure group intervention']","['distress', 'psychological functioning', 'BSI Global Severity Index (GSI) and the Centers for Epidemiologic Studies Depression scale (CES-D) scores', 'BSI GSI and Positive Symptom Total, CES-D, and EORTC emotional functioning subscale scores', 'psychological functioning and quality of life (QOL', 'European Organization for Research and Treatment of Cancer (EORTC) global QOL scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002783', 'cui_str': 'Epidemiological Studies'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",,0.0251688,The Healthy Expressions group demonstrated significantly greater changes in distress compared with the control group at Month 2 on the BSI Global Severity Index (GSI) and the Centers for Epidemiologic Studies Depression scale (CES-D) scores (P < .05 for each); differences in the European Organization for Research and Treatment of Cancer (EORTC) global QOL scores approached significance (P = .063).,"[{'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Carmack', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, Texas 77230-1439, USA. ccarmack@mdanderson.org'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basen-Engquist', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Greisinger', 'Affiliation': ''}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Rodriguez-Bigas', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wolff', 'Affiliation': ''}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Barker', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Baum', 'Affiliation': ''}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Pennebaker', 'Affiliation': ''}]",Cancer,['10.1002/cncr.26110']
2520,21445641,High-dose selenium reduces ventilator-associated pneumonia and illness severity in critically ill patients with systemic inflammation.,"PURPOSE


To confirm the pharmacodynamics and evaluate the efficacy of high-dose selenium (Se) administered by continuous infusion, following an initial loading bolus of selenite, on clinical outcome in critically ill patients with systemic inflammatory response syndrome (SIRS).
METHODS


Prospective, placebo-controlled, randomized, single-blinded phase II study in a multidisciplinary university hospital intensive care unit (ICU). Two groups of patients with SIRS, age >18 years, and Acute Physiology and Chronic Health Evaluation (APACHE) II ≥15 (n = 35) were randomized to receive either placebo or intravenous selenite as a bolus-loading dose of 2,000 μg Se followed by continuous infusion of 1,600 μg Se per day for 10 days. Blood samples were analyzed before randomization (day 0) then at days 3, 7, and 10. Clinical outcome was assessed by Sequential Organ Failure Assessment (SOFA) score. Hospital-acquired pneumonia including ventilator-associated pneumonia (VAP), adverse events, and other safety parameters were monitored as secondary endpoints.
RESULTS


SOFA score decreased significantly in the selenite group at day 10 (1.3 ± 1.2 versus 4.6 ± 2.0, p = 0.0001). Early VAP rate was lower in the selenite group (6.7% versus 37.5%, p = 0.04), and hospital-acquired pneumonia was lower after ICU discharge (p = 0.03). Glutathione peroxidase-3 (GPx-3) activity increased in both groups, reaching a maximum at day 7 (0.62 ± 0.24 versus 0.28 ± 0.14 U/mL, p = 0.001) in the selenite group. No adverse events attributable to selenite were observed.
CONCLUSIONS


Daily infusion of 1,600 μg Se (as selenite), following an initial bolus of 2,000 μg, is novel and without short-term adverse events. High-dose parenteral selenite significantly increases Se status, improves illness severity, and lowers incidence of hospital-acquired pneumonia including early VAP for SIRS patients in ICU.",2011,"Early VAP rate was lower in the selenite group (6.7% versus 37.5%, p = 0.04), and hospital-acquired pneumonia was lower after ICU discharge (p = 0.03).","['multidisciplinary university hospital intensive care unit (ICU', 'critically ill patients with systemic inflammation', 'critically ill patients with systemic inflammatory response syndrome (SIRS', 'Two groups of patients with SIRS, age >18\xa0years, and Acute Physiology and Chronic Health Evaluation (APACHE)\xa0II ≥15 (n\xa0=\xa035']","['high-dose selenium (Se', 'placebo', 'High-dose selenium', 'placebo or intravenous selenite']","['SOFA score', 'Hospital-acquired pneumonia including ventilator-associated pneumonia (VAP), adverse events, and other safety parameters', 'Blood samples', 'Sequential Organ Failure Assessment (SOFA) score', 'Glutathione peroxidase-3 (GPx-3) activity', 'Se status, improves illness severity, and lowers incidence of hospital-acquired pneumonia including early VAP', 'Early VAP rate', 'hospital-acquired pneumonia']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242966', 'cui_str': 'Sepsis Syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243028', 'cui_str': 'APACHE II'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0036580', 'cui_str': 'Selenite'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",35.0,0.245172,"Early VAP rate was lower in the selenite group (6.7% versus 37.5%, p = 0.04), and hospital-acquired pneumonia was lower after ICU discharge (p = 0.03).","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Manzanares', 'Affiliation': 'Intensive Care Unit, Department of Critical Care, Hospital de Clínicas: Dr. Manuel Quintela, School of Medicine (University Hospital), UDELAR, Avda Italia s/n esq. Las Heras. CP, 11600, Montevideo, Uruguay. wmanzanares@adinet.com.uy'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Biestro', 'Affiliation': ''}, {'ForeName': 'María H', 'Initials': 'MH', 'LastName': 'Torre', 'Affiliation': ''}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Galusso', 'Affiliation': ''}, {'ForeName': 'Gianella', 'Initials': 'G', 'LastName': 'Facchin', 'Affiliation': ''}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Hardy', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-011-2212-6']
2521,21316861,The influence of client behavior during motivational interviewing on marijuana treatment outcome.,Psychotherapy process research continues to be important in identifying within session client and therapist behaviors related to outcome. Motivational Interviewing (MI) assumes that the type of client language elicited within session is important. Client behavior was coded from 61 MI sessions with marijuana dependent adults. Sessions were coded for client language using the Client Language and Commitment Scale. Client statements indicating desire and reasons for change were significantly predictive of marijuana treatment outcome through the 34-month follow-up above and beyond baseline levels of marijuana use or motivation for change. Commitment language was not associated with outcomes. These findings suggest specific types of client language statements predict marijuana treatment outcome and are durable to a 34-month follow-up.,2011,Client statements indicating desire and reasons for change were significantly predictive of marijuana treatment outcome through the 34-month follow-up above and beyond baseline levels of marijuana use or motivation for change.,[],['Motivational Interviewing (MI'],[],[],"[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]",[],,0.0147509,Client statements indicating desire and reasons for change were significantly predictive of marijuana treatment outcome through the 34-month follow-up above and beyond baseline levels of marijuana use or motivation for change.,"[{'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'University of Washington, School of Social Work, Innovative Programs Research Group, 909 NE 43rd St, Suite 304, Seattle, WA, 98105-6020, United States. Electronic address: ddwalker@u.washington.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stephens', 'Affiliation': 'Virginia Tech, Department of Psychology, 0436, Blacksburg, VA, 24061, United States.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Rowland', 'Affiliation': 'Virginia Tech, Department of Psychology, 0436, Blacksburg, VA, 24061, United States.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Roffman', 'Affiliation': 'University of Washington, School of Social Work, Innovative Programs Research Group, 909 NE 43rd St, Suite 304, Seattle, WA, 98105-6020, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2011.01.009']
2522,30713413,Reasons for Exclusion from a Smoking Cessation Trial: An Analysis by Race/Ethnicity.,"Objective


The exclusion criteria of tobacco cessation randomized clinical trials (RCTs) may have unintended consequences on inclusion and cessation disparities. We examined racial/ethnic differences in: a) exclusion from a group-based cessation RCT; and b) reasons for exclusion.
Design


Quasi-experimental. Inclusion criteria were self-identification as African American/Black, non-Hispanic White, or Hispanic (any race), adults, minimum five cigarettes/day or carbon monoxide reading of ≥ 8 parts per million (ppm), interest in quitting, and spoke/read English. Data were obtained from a parent trial, which is ongoing and will be completed in 2019. Analyses for our present study on participant screening and enrollment were conducted in 2018.
Main Outcome Measures


Study ineligibility, and reasons for exclusion (contraindications for nicotine patch use, serious mental illness [SMI, eg, bipolar disorder or schizophrenia], alcohol dependence or illicit drug use, current tobacco treatment, attendance barriers [eg, transportation], and other concerns [eg, aggressive, intoxicated, disruptive, visibly ill]).
Results


Of 1,206 individuals screened, 36% were ineligible. The most frequent reasons were SMI (28%), alcohol dependence or drug use (10%), and attendance barriers (7%). Ineligibility was greater among African Americans (42%) and Hispanics (37%), compared with Whites (24%; P<.001). Compared with African Americans and Hispanics, Whites were more likely to be excluded for single reasons, including attendance barriers, and medical conditions (P<.05). African Americans were more than twice as likely as Whites to be excluded for 3 or more reasons (12% vs 5% respectively, P<.05).
Conclusions


A notable proportion of smokers were ineligible for this RCT, with SMI as the greatest single cause. Racial/ethnic minorities were more likely to be excluded, with African Americans deemed ineligible for multiple reasons. Findings have implications for RCT generalizability, addressing tobacco disparities and health equity.",2019,"Ineligibility was greater among African Americans (42%) and Hispanics (37%), compared with Whites (24%; P<.001).","['African Americans', '1,206 individuals screened, 36% were ineligible', 'Inclusion criteria were self-identification as African American/Black, non-Hispanic White, or Hispanic (any race), adults, minimum five cigarettes/day or carbon monoxide reading of ≥ 8 parts per million (ppm), interest in quitting, and spoke/read English']",[],"['Ineligibility', 'alcohol dependence or drug use']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C1277154', 'cui_str': 'Reads English'}]",[],"[{'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}]",36.0,0.0595814,"Ineligibility was greater among African Americans (42%) and Hispanics (37%), compared with Whites (24%; P<.001).","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Webb Hooper', 'Affiliation': 'Case Western Reserve University, Case Comprehensive Cancer Center.'}, {'ForeName': 'Taghrid', 'Initials': 'T', 'LastName': 'Asfar', 'Affiliation': 'University of Miami Miller School of Medicine, Department of Public Health Sciences and Sylvester Comprehensive Cancer Center.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Unrod', 'Affiliation': 'Moffitt Cancer Center.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Dorsey', 'Affiliation': 'University of Miami Miller School of Medicine, Department of Public Health Sciences and Sylvester Comprehensive Cancer Center.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Correa', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Brandon', 'Affiliation': 'Moffitt Cancer Center.'}, {'ForeName': 'Vani N', 'Initials': 'VN', 'LastName': 'Simmons', 'Affiliation': 'Moffitt Cancer Center.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Antoni', 'Affiliation': 'University of Miami Miller School of Medicine, Department of Public Health Sciences and Sylvester Comprehensive Cancer Center.'}, {'ForeName': 'Tulay', 'Initials': 'T', 'LastName': 'Koru-Sengul', 'Affiliation': 'University of Miami Miller School of Medicine, Department of Public Health Sciences and Sylvester Comprehensive Cancer Center.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lee', 'Affiliation': 'University of Miami Miller School of Medicine, Department of Public Health Sciences and Sylvester Comprehensive Cancer Center.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Moffitt Cancer Center.'}]",Ethnicity & disease,['10.18865/ed.29.1.23']
2523,21518250,Acceptability of three novel lipid-based nutrient supplements among Malawian infants and their caregivers.,"We tested the acceptability of three new lipid-based nutrient supplements (LNSs) in two independent phases among 18 8-12-month-old healthy rural Malawians and their caregivers. In phase 1, acceptability was assessed by offering three new LNSs in random order, and an LNS already determined to be acceptable, Nutributter(®), each added to 30 g of warm maize porridge over three consecutive days. In phase 2, infants from each village were provided one of the new supplements for a 2-week home-use trial. Outcome measures included the amount consumed, time completion of the dose and the maternal rating of likeability on a 5-point scale. The supplements were rated acceptable if consumption was over 50% of the offered dose in phase 1. The mean (95% confidence interval) proportion of the LNS test meals consumed under direct observation was 88% (82-94%) for LNS-10gM, 90% (84-95%) for LNS-20gM, 87% (79-95%) for LNS-20gNoM, and 86% (83-90%) for Nutributter. The median (25th and 75th centile) time (minutes) for completing the offered test meal was 4 (2, 7) for LNS-10gM, 5 (3, 6) for LNS-20gM, 4 (3, 8) for LNS-20gNoM and 4 (2, 6) for Nutributter. During both phases, almost all caregivers rated all study foods very likeable for themselves and their children, with mean scores slightly lower among the caregivers than among the infants. In the home-use phase, the test foods were almost exclusively used by the study participants with minimal sharing with siblings and other household members. Some infants were reported to prefer the new investigational products over traditional complementary food. Considering that the novel LNS was largely acceptable. Efficacy trials are now needed to assess their impact on child growth and development.",2011,"During both phases, almost all caregivers rated all study foods very likeable for themselves and their children, with mean scores slightly lower among the caregivers than among the infants.","['Malawian infants and their caregivers', 'two independent phases among 18 8-12-month-old healthy rural Malawians and their caregivers', 'participants with minimal sharing with siblings and other household members']","['novel lipid-based nutrient supplements', 'new lipid-based nutrient supplements (LNSs']","['amount consumed, time completion of the dose and the maternal rating of likeability on a 5-point scale']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0222045'}]",,0.0341225,"During both phases, almost all caregivers rated all study foods very likeable for themselves and their children, with mean scores slightly lower among the caregivers than among the infants.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Phuka', 'Affiliation': 'Community Health Department, College of Medicine, University of Malawi, P/Bag 360 Blantyre, Malawi. johnphuka@yahoo.co.uk'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': ''}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': ''}, {'ForeName': 'Mamane', 'Initials': 'M', 'LastName': 'Zeilani', 'Affiliation': ''}, {'ForeName': 'Yin Bun', 'Initials': 'YB', 'LastName': 'Cheung', 'Affiliation': ''}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Manary', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2011.00297.x']
2524,32424169,Aerobic exercise impacts the anterior cingulate cortex in adolescents with subthreshold mood syndromes: a randomized controlled trial study.,"Aerobic exercise is effective in alleviating mood symptoms while the mechanism is poorly understood. There are limited clinical trials that investigated the effect of exercise on the anterior cingulate cortex (ACC), a key brain region involved in mood regulations, in adolescents with subthreshold mood syndromes. This randomized controlled trial (RCT) of aerobic exercise was undertaken in a middle school in Guangzhou, China. Participants were adolescents aged 12-14 with subthreshold mood syndromes including depressive and manic symptoms and were randomly assigned to an aerobic exercise intervention or a psychoeducation control group. Participants in the exercise group received moderate-intensity exercise intervention, consisting of 30 mins running, 4 days per week for 3 months. The primary outcome in this study was structural changes in the ACC from baseline to post intervention. The trial was registered with ClinicalTrial.gov (NCT03300778). Of 56 participants who met the criteria for subthreshold mood syndromes, 39 (41.03% males) had complete MRI data, with 20 and 19 subjects in the exercise and control group, respectively. At baseline, demographic information (e.g., age and sex), clinical symptoms, and the gray matter volume and cortical thickness of ACC were matched between the two groups. After 12 weeks of treatment, participants in the exercise group displayed increased gray matter volume of the left rostral ACC (F 1,30  = 5.73, p = 0.02) and increased cortical thickness of the right rostral ACC (F 1,30  = 7.83, p = 0.01) when compared with the control group. No significant differences were found for caudal ACC cortical thickness and gray matter volume. Our data demonstrate that 12-week, moderate-intensity aerobic exercise can induce structural changes in the rostral ACC in adolescents with subthreshold mood syndromes.",2020,No significant differences were found for caudal ACC cortical thickness and gray matter volume.,"['adolescents with subthreshold mood syndromes', '56 participants who met the criteria for subthreshold mood syndromes, 39 (41.03% males) had complete MRI data, with 20 and 19 subjects in the exercise and control group, respectively', 'Participants were adolescents aged 12-14 with subthreshold mood syndromes including depressive and manic symptoms', 'middle school in Guangzhou, China']","['Aerobic exercise', 'moderate-intensity exercise intervention', 'aerobic exercise intervention or a psychoeducation control group', 'aerobic exercise']","['gray matter volume and cortical thickness of ACC', 'caudal ACC cortical thickness and gray matter volume', 'gray matter volume of the left rostral ACC', 'cortical thickness of the right rostral ACC']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0205090', 'cui_str': 'Right'}]",56.0,0.118219,No significant differences were found for caudal ACC cortical thickness and gray matter volume.,"[{'ForeName': 'Kangguang', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China. linkangguang@163.com.'}, {'ForeName': 'Brendon', 'Initials': 'B', 'LastName': 'Stubbs', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Zou', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Guangzhou Medical University (GuangzhouHuiai Hospital), Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Weicong', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Academician workstation of Mood and Brain Sciences, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Academician workstation of Mood and Brain Sciences, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Guangzhou Medical University (GuangzhouHuiai Hospital), Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Yuanxuan Middle School, Huadu district, Guangzhou, China.'}, {'ForeName': 'Yanxiong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Mabel Ngai Kiu', 'Initials': 'MNK', 'LastName': 'Wong', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Runhua', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Bess Yin-Hung', 'Initials': 'BY', 'LastName': 'Lam', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. bess.lam@polyu.edu.hk.'}, {'ForeName': 'Guiyun', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}]",Translational psychiatry,['10.1038/s41398-020-0840-8']
2525,32423941,Internet-based cognitive-behavioural therapy for prevention of depression during pregnancy and in the post partum (iPDP): a protocol for a large-scale randomised controlled trial.,"INTRODUCTION


The objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive-behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.
METHODS AND ANALYSIS


The target study population will be pregnant women of 16-20 weeks gestation who are currently users of 'Luna Luna Baby', the most widely used app for pregnant women in Japan. Those who meet the eligibility criteria will be randomly allocated to the 6-module internet CBT programme that was newly developed for pregnant women (n=2500), or to a treatment-as-usual control group (n=2500). Participants in the intervention groups will be required to complete the programme by 32 weeks gestation. The primary outcomes are the number of new onsets of MDE, measured by using WHO Composite International Diagnostic Interview 3.0 at 32 weeks gestation and 3 months post partum. Survival analysis will be conducted to test for the effectiveness of the intervention on the time to the onset of MDE.
ETHICS AND DISSEMINATION


The study plan has been approved by the Research Ethics Review Board of the Graduate School of Medicine/Faculty of Medicine, the University of Tokyo (2019150NI). If the intervention programmes are found to produce a significant positive effect in this RCT, these programmes can be made available for all users of the app in the future.
TRIAL REGISTRATION NUMBER


UMIN000038190; Pre-results.",2020,"The objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive-behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.
","[""pregnant women of 16-20 weeks gestation who are currently users of 'Luna Luna Baby', the most widely used app for pregnant women in Japan"", 'pregnant women']","['6-module internet CBT programme', 'Internet-based cognitive-behavioural therapy', 'smartphone-based cognitive-behavioural therapy (CBT']","['number of new onsets of MDE, measured by using WHO Composite International Diagnostic Interview']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451085', 'cui_str': 'Composite international diagnostic interview'}]",,0.184564,"The objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive-behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.
","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Nishi', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan d-nishi@m.u-tokyo.ac.jp.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Imamura', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Obikane', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Natsu', 'Initials': 'N', 'LastName': 'Sasaki', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Naonori', 'Initials': 'N', 'LastName': 'Yasuma', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Sekiya', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Biostatistics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Norito', 'Initials': 'N', 'LastName': 'Kawakami', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-036482']
2526,32424154,Bortezomib-dexamethasone as maintenance therapy or early retreatment at biochemical relapse versus observation in relapsed/refractory multiple myeloma patients: a randomized phase II study.,,2020,,['relapsed/refractory multiple myeloma patients'],['Bortezomib-dexamethasone'],[],"[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]",[],,0.0167875,,"[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Mina', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Belotti', 'Affiliation': 'Division of Hematology, Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Petrucci', 'Affiliation': 'Hematology, Department of Translational and Precision Medicine, Azienda Ospedaliera Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Zambello', 'Affiliation': 'Padova University School of Medicine, Hematology and Clinical Immunology, Padova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Capra', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Di Lullo', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Ronconi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Pescosta', 'Affiliation': 'Reparto di Ematologia e Centro TMO, Ospedale Centrale, Bolzano, Italy.'}, {'ForeName': 'Mariella', 'Initials': 'M', 'LastName': 'Grasso', 'Affiliation': 'S.C. Ematologia, Azienda Ospedaliera Santa Croce - Carle, Cuneo, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Monaco', 'Affiliation': ""Dipartimento di Ematologia e Medicina Trasfusionale, Azienda Ospedaliera 'SS. Antonio e Biagio e Cesare Arrigo', Alessandria, Italy.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cellini', 'Affiliation': 'U.O.C. EMATOLOGIA, Ospedale Santa Maria delle Croci, Ravenna, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Gobbi', 'Affiliation': 'Clinical Hematology, Ospedale Policlinico S. Martino, Istituto di Ricovero e Cura a Carattere Scientifico, Genoa, Italy.'}, {'ForeName': 'Stelvio', 'Initials': 'S', 'LastName': 'Ballanti', 'Affiliation': 'Ematologia con TMO, Ospedale Santa Maria della Misericordia di Perugia, Perugia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'de Fabritiis', 'Affiliation': 'Hematology, St. Eugenio Hospital, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Maria Letizia', 'Initials': 'ML', 'LastName': 'Mosca-Siez', 'Affiliation': 'Division of Hematology, Department of Medicine, Ospedale degli Infermi, Biella, Italy.'}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Marchetti', 'Affiliation': 'Day Hospital Ematologico, Ospedale Cardinal Massaia, Asti, Italy.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Università degli Studi di Perugia - Azienda Ospedaliera Santa Maria, Terni, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Offidani', 'Affiliation': 'Clinica di Ematologia, Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona, Ancona, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Giuliani', 'Affiliation': 'Dipartimento di Medicina e Chirurgia, Università di Parma, Parma, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ria', 'Affiliation': 'Internal Medicine ""G. Baccelli"", Department of Biomedical Science, University of Bari ""Aldo Moro"" Medical School, Bari, Italy.'}, {'ForeName': 'Pellegrino', 'Initials': 'P', 'LastName': 'Musto', 'Affiliation': 'Hematology, IRCCS CROB, Rionero in Vulture (Pz), Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Romano', 'Affiliation': 'Division of Hematology, AOU Policlinico-OVE, University of Catania, Catania, Italy.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Hematology, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Boccadoro', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Larocca', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy. alelarocca@hotmail.com.'}]",Blood cancer journal,['10.1038/s41408-020-0326-1']
2527,31536819,Combined resection-recession in true divergence excess sensory exotropia.,"PURPOSE


To assess the effect of combined resection and recession on the same lateral rectus muscle in patients with true divergence excess sensory exotropia.
METHODS


Patients were divided into two groups. One group of patients underwent combined resection-recession of the lateral rectus muscle in one eye (LR group); the other group, with exodeviation of >40 Δ  for distance underwent additional ipsilateral medial rectus resection (LR + MR group). Postoperative measurements were taken at 1 week, 1 month, and 3 months.
RESULTS


Eleven patients were included in the study (mean age, 23.5 ± 6.7 years): 7 in the LR group and 4 in the LR + MR group. For the LR group, mean preoperative deviation was 35.7 Δ  ± 3.5 Δ  at distance and 16.3 Δ  ± 3.9 Δ  at near. The mean near-distance disparity (NDD) was 11.4 Δ  ± 2.7 Δ . The mean lateral rectus recession was 8.6 ± 1.1 mm: the mean resection, 4.3 ± 0.5 mm. At 3 months, mean deviation at distance was 8.3 Δ  ± 2.1 Δ ; at near, 3.1 Δ  ± 1.6 Δ  (P = 0.01). The NDD was 5.7 Δ  ± 2.7 Δ  (P = 0.01). For the LR + MR group, mean preoperative deviations at distance was 65.0 Δ  ± 12.9 Δ ; at near, 35.0 Δ  ± 12.2 Δ . The mean NDD was 30.0 Δ  ± 4.0 Δ . Mean lateral rectus recession was 9.5 ± 1.8 mm; the mean resection, 4.8 ± 0.8 mm. The mean medial rectus resection was 5.5 ± 0.6 mm. At 3 months, mean deviation at distance was 8.3 Δ  ± 2.1 Δ ; at near, 3.1 Δ  ± 1.6 Δ  (P = 0.06). The NDD was 5.7 Δ  ± 2.7 Δ  (P = 0.06).
CONCLUSIONS


In our study combined resection and recession of the same lateral rectus muscle in patients with divergence excess sensory exotropia significantly reduced the NDD, with no adverse outcomes.",2019,"The mean lateral rectus recession was 8.6 ± 1.1 mm: the mean resection, 4.3 ± 0.5 mm.","['Eleven patients were included in the study (mean age, 23.5 ± 6.7 years): 7 in the LR group and 4 in the LR+MR group', 'Patients were divided into two groups', 'patients with true divergence excess sensory exotropia']","['Combined resection-recession', 'combined resection-recession of the lateral rectus muscle in one eye (LR group); the other group, with exodeviation of >40 Δ  for distance underwent additional ipsilateral medial rectus resection (LR+MR group', 'combined resection and recession']","['mean lateral rectus recession', 'mean medial rectus resection', 'Mean lateral rectus recession', 'mean near-distance disparity (NDD', 'mean preoperative deviation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C1409057', 'cui_str': 'Divergence excess'}, {'cui': 'C1276000', 'cui_str': 'Sensory exotropia'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0582821', 'cui_str': 'Lateral rectus muscle structure (body structure)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4551670', 'cui_str': 'Exodeviation'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0395297', 'cui_str': 'Medial rectus resection (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0395310', 'cui_str': 'Lateral rectus recession (procedure)'}, {'cui': 'C0395297', 'cui_str': 'Medial rectus resection (procedure)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]",40.0,0.0250946,"The mean lateral rectus recession was 8.6 ± 1.1 mm: the mean resection, 4.3 ± 0.5 mm.","[{'ForeName': 'Karthika', 'Initials': 'K', 'LastName': 'Bhaskaran', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Adarsh Kumar', 'Initials': 'AK', 'LastName': 'Shashni', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. Electronic address: drpsharma57@yahoo.com.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Saxena', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Phuljhele', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2019.06.009']
2528,32424045,C-reactive protein-guided antibiotic prescribing for COPD exacerbations: a qualitative evaluation.,"BACKGROUND


Antibiotics are prescribed to >70% of patients presenting in primary care with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The PACE randomised controlled trial found that a C-reactive protein point-of-care test (CRP-POCT) management strategy for AECOPD in primary care resulted in a 20% reduction in patient-reported antibiotic consumption over 4 weeks.
AIM


To understand perceptions of the value of CRP-POCT for guiding antibiotic prescribing for AECOPD; explore possible mechanisms, mediators, and pathways to effects; and identify potential barriers and facilitators to implementation from the perspectives of patients and clinicians.
DESIGN AND SETTING


Qualitative process evaluation in UK general practices.
METHOD


Semi-structured telephone interviews with 20 patients presenting with an AECOPD and 20 primary care staff, purposively sampled from the PACE study. Interviews were audio-recorded, transcribed, and analysed using framework analysis.
RESULTS


Patients and clinicians felt that CRP-POCT was useful in guiding clinicians' antibiotic prescribing decisions for AECOPD, and were positive about introduction of the test in routine care. The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients. Some clinicians thought the CRP-POCT should be routinely used in consultations for AECOPD; others favoured use only when there was decisional uncertainty. CRP-POCT cartridge preparation time and cost were potential barriers to implementation.
CONCLUSION


CRP-POCT-guided antibiotic prescribing for AECOPD had high acceptability, but commissioning arrangements and further simplification of the CRP-POCT need attention to facilitate implementation in routine practice.",2020,"The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients.","['Qualitative process evaluation in UK general practices', 'COPD exacerbations', 'Semi-structured telephone interviews with 20 patients presenting with an AECOPD and 20 primary care staff, purposively sampled from the PACE study', 'patients presenting in primary care with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD']","['C-reactive protein point-of-care test (CRP-POCT', 'C-reactive protein-guided antibiotic prescribing']",[],"[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",[],20.0,0.0494891,"The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients.","[{'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Cardiff School of Sport and Health Sciences, Cardiff Metropolitan University, Cardiff, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Stanton', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Singh-Mehta', 'Affiliation': 'Research and Innovation Services, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Bates', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Gal', 'Affiliation': 'Research and Innovation Services, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas-Jones', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Llor', 'Affiliation': 'University Institute in Primary Care Research Jordi Gol, Via Roma Health Centre, Barcelona, Spain.'}, {'ForeName': 'Hasse', 'Initials': 'H', 'LastName': 'Melbye', 'Affiliation': 'General Practice Research Unit, Department of Community Medicine, UIT the Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Cals', 'Affiliation': 'Department of Family Medicine, CAPHRI Care and Public Health Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'White', 'Affiliation': ""Population Health and Environment Sciences, King's College London, London, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Francis', 'Affiliation': 'School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X709865']
2529,32424022,Whole-Grain Processing and Glycemic Control in Type 2 Diabetes: A Randomized Crossover Trial.,"OBJECTIVE


To consider the effects of whole-grain processing, specifically milling, on glycemic control in free-living adults with type 2 diabetes.
RESEARCH DESIGN AND METHODS


Participants of this crossover trial were randomized to two interventions of 2 weeks, separated by washout. They were advised to replace the grain foods they normally consumed with intervention foods. Intervention foods were nutrient-matched whole-grain products of wheat, oats, and brown rice that differed in their degree of processing. No other lifestyle advice was given. Continuous glucose monitoring systems were worn. Other cardiometabolic risk factors and alkylresorcinols (a biomarker of whole-grain intake) were measured pre- and postintervention.
RESULTS


Thirty-one adults with type 2 diabetes (63 ± 13 years old, BMI 32.4 ± 7 kg/m 2 , HbA 1c  7.5 ± 3.4% [59 ± 14 mmol/mol]) commenced the trial; 28 (90%) completed both interventions. The increase in alkylresorcinols did not differ between interventions, and there was no difference in reported energy intake. Postprandial responses were 9% (95% CI 3-15) lower following breakfast and 6% (1-10) lower following all meals of less-processed whole grains when compared with finely milled grains. Day-long glycemic variability also reduced when measured by 24-h SD (-0.16 mmol/L [95% CI -0.25 to -0.06]) and mean amplitude of glycemic excursion (-0.36 [95% CI -0.65 to -0.08]). Mean change in body weight differed by 0.81 kg (95% CI 0.62-1.05) between interventions, increasing during the finely milled intervention and decreasing during the less-processed whole-grain intervention. This was not a mediating factor for the glycemic variables considered.
CONCLUSIONS


Consuming less-processed whole-grain foods over 2 weeks improved measures of glycemia in free-living adults with type 2 diabetes compared with an equivalent amount of whole-grain foods that were finely milled. Dietary advice should promote the consumption of minimally processed whole grains.",2020,"The increase in alkylresorcinols did not differ between interventions, and there was no difference in reported energy intake.","['Type 2 Diabetes', 'free-living adults with type 2 diabetes', 'Thirty-one adults with type 2 diabetes (63 ± 13 years old, BMI 32.4 ± 7 kg/m 2 , HbA 1c  7.5 ± 3.4% [59 ± 14 mmol/mol]) commenced the trial; 28 (90%) completed both interventions']","['whole-grain processing, specifically milling']","['glycemia', 'reported energy intake', 'mean amplitude of glycemic excursion', 'Mean change in body weight', 'Postprandial responses', 'alkylresorcinols']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0599997', 'cui_str': 'Mill'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}]",31.0,0.0556802,"The increase in alkylresorcinols did not differ between interventions, and there was no difference in reported energy intake.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Åberg', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Neumann', 'Affiliation': 'Department of Pathology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Alastair B', 'Initials': 'AB', 'LastName': 'Ross', 'Affiliation': 'AgResearch, Lincoln University, Lincoln, New Zealand.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Reynolds', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand andrew.reynolds@otago.ac.nz.'}]",Diabetes care,['10.2337/dc20-0263']
2530,21143588,The effect of tailor-made information on vitamin D status of immigrant mothers in Norway: a cluster randomized controlled trial.,"A high prevalence of vitamin D deficiency has been reported in non-Western immigrants in Norway. Our objective was to test whether written information about how to improve vitamin D status could improve the vitamin D status in immigrants mothers attending child health clinics. In this cluster randomized controlled trial in eight child health clinics in Oslo, mothers aged 18-43 years with Pakistani, Turkish, or Somali background were included when their infants were 6 weeks old. The public health nurses gave the intervention group a brochure with information on how to improve vitamin D status, written in their native language. They were compared with a control group receiving usual care, consisting of oral information only. The principal outcome measure was increase in serum 25-hydroxyvitamin D [s-25(OH) D] in mothers 7 weeks later. Forty-four mothers completed the study. Mean baseline s-25(OH) D was 29.1 (14.8) nmol l(-1) in the intervention and 19.4 (9.2) in the control group. There was no significant increase in s-25(OH) D from baseline to follow-up in the intervention [6.3 (95%CI: -1.9, 14.4) nmol l(-1) )] or in the control group [2.9 (95% CI [confidence interval]: -1.2, 7.0) nmol l(-1) ]. When adjusting for baseline s-25(OH) D concentration the mean difference in increase between the intervention and control group was 1.4 (95% CI: -18.7, 21.4) nmol l(-1) (P = 0.87). Adjustment for ethnicity, season and mother's educational background did not alter the results. In sum, providing immigrant mothers with written information about how to improve their vitamin D status did not have an effect on the mothers' vitamin D status.",2011,There was no significant increase in s-25(OH),"['Forty-four mothers completed the study', 'non-Western immigrants in Norway', 'eight child health clinics in Oslo, mothers aged 18-43 years with Pakistani, Turkish, or Somali background were included when their infants were 6 weeks old', 'immigrants mothers attending child health clinics', 'immigrant mothers in Norway']","['tailor-made information', 'control group receiving usual care, consisting of oral information only']","['Mean baseline s-25(OH', 's-25(OH', 'serum 25-hydroxyvitamin D [s-25(OH) D', 'vitamin D status']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337814', 'cui_str': 'Pakistani (Urduspeakers) (ethnic group)'}, {'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C0337847', 'cui_str': 'Somalis (ethnic group)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444858', 'cui_str': 'AM 6 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.0994579,There was no significant increase in s-25(OH),"[{'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Madar', 'Affiliation': 'Institute of General Practice and Community Medicine, University of Oslo, Oslo, Norway. a.a.madar@medisin.uio.no'}, {'ForeName': 'Knut-Inge', 'Initials': 'KI', 'LastName': 'Klepp', 'Affiliation': ''}, {'ForeName': 'Haakon E', 'Initials': 'HE', 'LastName': 'Meyer', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2009.00238.x']
2531,32424029,Response to: 'Use of tanezumab for patients with hip and knee osteoarthritis with reference to a randomised clinical trial by Berenbaum and colleagues' by Riddle and Perera.,,2020,,['patients with hip and knee osteoarthritis with reference'],['tanezumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C2346819', 'cui_str': 'tanezumab'}]",[],,0.0386779,,"[{'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Berenbaum', 'Affiliation': 'Department of Rheumatology, Sorbonne Université, INSERM CRSA, AP-HP Hopital Saint-Antoine, Paris, France francis.berenbaum@aphp.fr.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Blanco', 'Affiliation': 'Servicio de Reumatología, INIBC-Complejo Hospitalario Universitario A Coruña, La Coruña, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Department of Radiology, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Miki', 'Affiliation': 'Faculty of Health Science, Osaka Yukioka College of Health Science, Hayaishi Hospital, Osaka, Japan.'}, {'ForeName': 'Takaharu', 'Initials': 'T', 'LastName': 'Yamabe', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Viktrup', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Rod', 'Initials': 'R', 'LastName': 'Junor', 'Affiliation': 'Pfizer Ltd, Tadworth, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Carey', 'Affiliation': 'Pfizer Ltd, Tadworth, UK.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Brown', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Verburg', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217629']
2532,32430189,Experience of an upper limb training program with a non-immersive virtual reality system in patients after stroke: a qualitative study.,"OBJECTIVES


The YouGrabber (YG) is a new virtual reality training system that focuses on unilateral and bimanual activities. This nested study was part of a larger multicenter randomized controlled trial and explored experiences of people with chronic stroke during a 4 weeks intensive upper limb training with YG.
DESIGN


A qualitative design using semi-structured, face-to-face interviews. A phenomenological descriptive approach was used, with data coded, categorized and summarized using a thematic analysis. Topics investigated included: the experience of YG training, perceived impact of YG training on arm function, and the role of the treating therapist.
RESULTS


Five people were interviewed (one female, age range 55 to 75 years, 1 to 6 years poststroke). Seven main themes were identified: (1) general experience, (2) expectations, (3) feedback, (4) arm function, (5) physiotherapist's role, (6) fatigue, (7) motivation. Key experiences reported included feelings of motivation and satisfaction, with positive factors identified as challenge, competition, fun and effort. The YG training appeared to trigger greater effort, however fatigue was experienced at the end of the training. Overall, patients described positive changes in upper limb motor function and activity level, e.g. automatic arm use. While the opportunity for self-practice was appreciated, input from the therapist at the start of the intervention was deemed important for safety and confidence.
CONCLUSIONS


Reported experiences were mostly positive and the participants were motivated to practice intensively. They enjoyed the challenging component of the games.",2020,The YouGrabber (YG) is a new virtual reality training system that focuses on unilateral and bimanual activities.,"['people with chronic stroke during a 4 weeks intensive upper limb training with YG', 'Five people were interviewed (one female, age range 55 to 75 years, 1 to 6 years poststroke', 'patients after stroke']","['upper limb training program with a non-immersive virtual reality system', 'YG training']","[""general experience, (2) expectations, (3) feedback, (4) arm function, (5) physiotherapist's role, (6) fatigue, (7) motivation"", 'upper limb motor function and activity level, e.g. automatic arm use', 'feelings of motivation and satisfaction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0556501', 'cui_str': 'Upper limb training'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0556501', 'cui_str': 'Upper limb training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",5.0,0.0277916,The YouGrabber (YG) is a new virtual reality training system that focuses on unilateral and bimanual activities.,"[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Lehmann', 'Affiliation': 'Department of Physiotherapy, Inselspital, Bern University Hospital, Bern, Switzerland. Electronic address: isabelle.lehmann@insel.ch.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Baer', 'Affiliation': 'School of Health Sciences, Queen Margaret University, Edinburgh EH21 6UU, United Kingdom. Electronic address: gbaer@qmu.ac.uk.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Schuster-Amft', 'Affiliation': 'Research Department, Reha Rheinfelden, Rheinfelden, Switzerland; Institute for Rehabilitation and Performance Technology, Bern University of Applied Sciences, Burgdorf, Switzerland.'}]",Physiotherapy,['10.1016/j.physio.2017.03.001']
2533,20956707,Diabetes control with reciprocal peer support versus nurse care management: a randomized trial.,"BACKGROUND


Resource barriers complicate diabetes care management. Support from peers may help patients manage their diabetes.
OBJECTIVE


To compare a reciprocal peer-support (RPS) program with nurse care management (NCM).
DESIGN


Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00320112)
SETTING


2 U.S. Department of Veterans Affairs health care facilities.
PATIENTS


244 men with hemoglobin A(1c) (HbA(1c)) levels greater than 7.5% during the previous 6 months.
MEASUREMENTS


The primary outcome was 6-month change in HbA(1c) level. Secondary outcomes were changes in insulin therapy; blood pressure; and patient reports of medication adherence, diabetes-related support, and emotional distress.
INTERVENTION


Patients in the RPS group attended an initial group session to set diabetes-related behavioral goals, receive peer communication skills training, and be paired with another age-matched peer patient. Peers were encouraged to talk weekly using a telephone platform that recorded call occurrence and provided reminders to promote peer contact. These patients could also participate in optional group sessions at 1, 3, and 6 months. Patients in the NCM group attended a 1.5-hour educational session and were assigned to a nurse care manager.
RESULTS


Of the 244 patients enrolled, 216 (89%) completed the HbA(1c) assessments and 231 (95%) completed the survey assessments at 6 months. Mean HbA(1c) level decreased from 8.02% to 7.73% (change, -0.29%) in the RPS group and increased from 7.93% to 8.22% (change, 0.29%) in the NCM group. The difference in HbA(1c) change between groups was 0.58% (P = 0.004). Among patients with a baseline HbA(1c) level greater than 8.0%, those in the RPS group had a mean decrease of 0.88%, compared with a 0.07% decrease among those in the NCM group (between-group difference, 0.81%; P < 0.001). Eight patients in the RPS group started insulin therapy, compared with 1 patient in the NCM group (P = 0.020). Groups did not differ in blood pressure, self-reported medication adherence, or diabetes-specific distress, but the RPS group reported improvement in diabetes social support.
LIMITATION


The study included only male veterans and lasted only 6 months.
CONCLUSION


Reciprocal peer support holds promise as a method for diabetes care management.",2010,The difference in HbA(1c) change between groups was 0.58% (P = 0.004).,"['244 patients enrolled, 216 (89%) completed the HbA(1c) assessments and 231 (95%) completed the survey assessments at 6 months', '2 U.S. Department of Veterans Affairs health care facilities.\nPATIENTS\n\n\n244 men with hemoglobin A(1c) (HbA(1c)) levels greater than 7.5% during the previous 6 months', 'male veterans and lasted only 6 months']","['1.5-hour educational session', 'reciprocal peer-support (RPS) program with nurse care management (NCM', 'reciprocal peer support versus nurse care management', 'RPS', 'NCM', 'initial group session to set diabetes-related behavioral goals, receive peer communication skills training, and be paired with another age-matched peer patient']","['6-month change in HbA(1c) level', 'HbA(1c) change', 'Mean HbA(1c) level', 'diabetes social support', 'blood pressure, self-reported medication adherence, or diabetes-specific distress', 'changes in insulin therapy; blood pressure; and patient reports of medication adherence, diabetes-related support, and emotional distress']","[{'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0037438'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",244.0,0.027429,The difference in HbA(1c) change between groups was 0.58% (P = 0.004).,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'University of Michigan and Ann Arbor Veterans Affairs Health Care System, Ann Arbor, Michigan 48113-0170, USA. mheisler@umich.edu'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Vijan', 'Affiliation': ''}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Makki', 'Affiliation': ''}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Piette', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/0003-4819-153-8-201010190-00007']
2534,31314050,Effect of Simvastatin-Ezetimibe Compared With Simvastatin Monotherapy After Acute Coronary Syndrome Among Patients 75 Years or Older: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Limited evidence is available regarding the benefit and hazard of higher-intensity treatment to lower lipid levels among patients 75 years or older. As a result, guideline recommendations differ for this age group compared with younger patients.
Objective


To determine the effect on outcomes and risks of combination ezetimibe and simvastatin compared with simvastatin monotherapy to lower lipid levels among patients 75 years or older with stabilized acute coronary syndrome (ACS).
Design, Setting, Participants


In this prespecified secondary analysis of the global, multicenter, prospective clinical randomized Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), outcomes and risks were compared by age among patients 50 years or older after a hospitalization for ACS. Data were collected from October 26, 2005, through July 8, 2010, with the database locked October 21, 2014. Data were analyzed May 29, 2015, through March 13, 2018, using Kaplan-Meier curves and Cox proportional hazards models.
Interventions


Double-blind randomized assignment to combined simvastatin and ezetimibe or simvastatin and placebo with follow-up for a median of 6 years (interquartile range, 4.3-7.1 years).
Main Outcomes and Measures


The primary composite end point consisted of death due to cardiovascular disease, myocardial infarction (MI), stroke, unstable angina requiring hospitalization, and coronary revascularization after 30 days. Individual adverse ischemic and safety end points and lipid variables were also analyzed.
Results


Of 18 144 patients enrolled (13 728 men [75.7%]; mean [SD] age, 64.1 [9.8] years), 5173 (28.5%) were 65 to 74 years old, and 2798 (15.4%) were 75 years or older at randomization. Treatment with simvastatin-ezetimibe resulted in lower rates of the primary end point than simvastatin-placebo, including 0.9% for patients younger than 65 years (HR, 0.97; 95% CI, 0.90-1.05) and 0.8% for patients 65 to 74 years of age (hazard ratio [HR], 0.96; 95% CI, 0.87-1.06), with the greatest absolute risk reduction of 8.7% for patients 75 years or older (HR, 0.80; 95% CI, 0.70-0.90) (P = .02 for interaction). The rate of adverse events did not increase with simvastatin-ezetimibe vs simvastatin-placebo among younger or older patients.
Conclusions and Relevance


In IMPROVE-IT, patients hospitalized for ACS derived benefit from higher-intensity therapy to lower lipid levels with simvastatin-ezetimibe compared with simvastatin monotherapy, with the greatest absolute risk reduction among patients 75 years or older. Addition of ezetimibe to simvastatin was not associated with any significant increase in safety issues among older patients. These results may have implications for guideline recommendations regarding lowering of lipid levels in the elderly.
Trial Registration


ClinicalTrials.gov identifier: NCT00202878.",2019,"Treatment with simvastatin-ezetimibe resulted in lower rates of the primary end point than simvastatin-placebo, including 0.9% for patients younger than 65 years (HR, 0.97; 95% CI, 0.90-1.05) and 0.8% for patients 65 to 74 years of age (hazard ratio [HR], 0.96; 95% CI, 0.87-1.06), with the greatest absolute risk reduction of 8.7% for patients 75 years or older (HR, 0.80; 95% CI, 0.70-0.90) (P = .02 for interaction).","['patients 75 years or older', 'median of 6 years (interquartile range, 4.3-7.1 years', 'patients 75 years or older with stabilized acute coronary syndrome (ACS', 'patients 50 years or older after a hospitalization for ACS', 'Participants', 'older patients', 'Results\n\n\nOf 18\u202f144 patients enrolled (13 728 men [75.7%]; mean [SD] age, 64.1 [9.8] years), 5173 (28.5%) were 65 to 74 years old, and 2798 (15.4%) were 75 years or older at randomization', 'Data were collected from October 26, 2005, through July 8, 2010, with the database locked October 21, 2014', 'Patients 75 Years or Older', 'younger or older patients']","['Simvastatin-Ezetimibe', 'simvastatin-placebo', 'combination ezetimibe and simvastatin', 'simvastatin-ezetimibe', 'simvastatin-ezetimibe vs simvastatin-placebo', 'ezetimibe to simvastatin', 'simvastatin monotherapy', 'Simvastatin Monotherapy', 'combined simvastatin and ezetimibe or simvastatin and placebo']","['rate of adverse events', 'Individual adverse ischemic and safety end points and lipid variables', 'lipid levels', 'death due to cardiovascular disease, myocardial infarction (MI), stroke, unstable angina requiring hospitalization, and coronary revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4517579', 'cui_str': '15.4 (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1532737', 'cui_str': 'ezetimibe / Simvastatin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",,0.259567,"Treatment with simvastatin-ezetimibe resulted in lower rates of the primary end point than simvastatin-placebo, including 0.9% for patients younger than 65 years (HR, 0.97; 95% CI, 0.90-1.05) and 0.8% for patients 65 to 74 years of age (hazard ratio [HR], 0.96; 95% CI, 0.87-1.06), with the greatest absolute risk reduction of 8.7% for patients 75 years or older (HR, 0.80; 95% CI, 0.70-0.90) (P = .02 for interaction).","[{'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Bach', 'Affiliation': 'Cardiovascular Division, Department of Medicine, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'White', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Bohula', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Califf', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Blazing', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University, Durham, North Carolina.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2306']
2535,31064808,B Part of It School Leaver protocol: an observational repeat cross-sectional study to assess the impact of a meningococcal serogroup B (4CMenB) vaccine programme on carriage of  Neisseria meningitidis .,"INTRODUCTION


Invasive meningococcal disease is uncommon but associated with a high-case fatality rate. Carriage prevalence of the causative bacteria,  Neisseria meningitidis , is high in adolescents. A large (n=34 500) cluster randomised controlled trial (RCT) to assess the impact of a meningococcal B (MenB) vaccine on meningococcal carriage was implemented in the state of South Australia (SA) for year 10, 11 and 12 senior school students in 2017-2018. This study will assess the impact of MenB vaccine (4CMenB) on carriage prevalence in school leavers in SA, 1 and 2 years after implementation of the cluster RCT in adolescents. Measuring the impact of population programmes on carriage can assist in informing future meningococcal immunisation programmes such as targeted age groups and use of catch-up campaigns.
METHODS AND ANALYSIS


This repeat cross-sectional study will assess carriage prevalence in 2018 and 2019. All school leavers who attended year 12 in any school in SA in 2018 or 2019 will be invited to participate in this study. An oropharyngeal swab will be taken from each participating student and a risk factor questionnaire completed by the student following informed consent. Students will attend clinics at SA universities, technical colleges, and metropolitan, rural and remote government council clinics. Confirmed vaccination history will allow a comparison in carriage prevalence between vaccinated and unvaccinated school leavers. A sample size of 4096 students per year will provide 80% power to detect a 20% difference in carriage prevalence of disease-causing meningococci (defined as genogroup A, B, C, W, X or Y) between years.
ETHICS AND DISSEMINATION


The study was approved by the Women's and Children's Health Network Human Research Ethics Committee. Results will be published in international peer review journals and presented at national and international conferences.
TRIAL REGISTRATION NUMBER


NCT03419533; Pre-results.",2019,"Measuring the impact of population programmes on carriage can assist in informing future meningococcal immunisation programmes such as targeted age groups and use of catch-up campaigns.
","['state of South Australia (SA) for year 10, 11 and 12 senior school students in 2017-2018', 'Students will attend clinics at SA universities, technical colleges, and metropolitan, rural and remote government council clinics', 'carriage prevalence in school leavers in SA, 1 and 2\u2009years after implementation of the cluster RCT in adolescents', 'All school leavers who attended year 12 in any school in SA in 2018 or 2019 will be invited to participate in this study', '2018 and 2019']","['MenB vaccine (4CMenB', 'meningococcal serogroup B (4CMenB) vaccine programme', 'meningococcal B (MenB) vaccine']","['carriage of  Neisseria meningitidis ', 'carriage prevalence of disease-causing meningococci']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0730261', 'cui_str': 'Attending clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557810', 'cui_str': 'Technical college'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C3859491', 'cui_str': 'meningococcal group B vaccine'}]","[{'cui': 'C0027571', 'cui_str': 'Neisseria'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",,0.0973144,"Measuring the impact of population programmes on carriage can assist in informing future meningococcal immunisation programmes such as targeted age groups and use of catch-up campaigns.
","[{'ForeName': 'Helen S', 'Initials': 'HS', 'LastName': 'Marshall', 'Affiliation': ""Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McMillan', 'Affiliation': ""Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Koehler', 'Affiliation': 'Communicable Disease Control Branch, SA Health, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lawrence', 'Affiliation': 'Microbiology Department, SA Pathology, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'MacLennan', 'Affiliation': 'Department of Zoology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Maiden', 'Affiliation': 'Department of Zoology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ramsay', 'Affiliation': 'Immunisation Department, Public Health England, London, UK.'}, {'ForeName': 'Shamez N', 'Initials': 'SN', 'LastName': 'Ladhani', 'Affiliation': 'Immunisation Department, Public Health England, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Trotter', 'Affiliation': 'Immunisation Department, Public Health England, London, UK.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Borrow', 'Affiliation': 'Meningococcal Reference Unit, Public Health England, Manchester, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Finn', 'Affiliation': 'School of Cellular and Molecular Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sullivan', 'Affiliation': 'School of Public Health, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Richmond', 'Affiliation': 'Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Institute for Child Health Research, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Kahler', 'Affiliation': 'Marshall Centre for Infectious Disease Research and Training, School of Biomedical Science, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Whelan', 'Affiliation': 'GlaxoSmithKline Vaccines, Amsterdam, Netherlands.'}, {'ForeName': 'Kumaran', 'Initials': 'K', 'LastName': 'Vadivelu', 'Affiliation': 'GlaxoSmith Kline Vaccines, Rockville, Maryland, USA.'}]",BMJ open,['10.1136/bmjopen-2018-027233']
2536,31535099,"Lateral alveolar ridge augmentation with autogenous block grafts fixed at a distance vs resorbable poly-D-L-lactide foil fixed at a distance: 5-year results of a single-blind, randomised controlled trial.","PURPOSE


To report the 5-year outcomes of autogenous bone block grafts fixed at a distance (BBG-D) versus a resorbable poly-D-L-lactide foil fixed at a distance (SonicWeld Rx shell technique [SWST]) randomised controlled trial, for lateral alveolar ridge augmentation.
MATERIALS AND METHODS


Thirty patients with a buccopalatal bone width of ≤ 3 mm were randomised into the following treatment groups: BBG-D and SWST. The implant survival, changes in bone morphology visualised in a cone beam computed tomography scan and periodontal parameters were assessed.
RESULTS


Thirteen patients in the BBG-D group and seven in the SWST group could be included in the analysis. All implants that osseointegrated initially (BBG-D = 13 and SWST = 7) were functional at the 5-year re-evaluation. The buccopalatal bone width significantly (P < 0.001) decreased over time regardless of the study group. A bone loss of 0.00 mm was observed at the distal implant shoulder in the BBG-D group and 0.29 mm (SD 0.49 mm) in the SWST group (P = 0.04). The mean buccal bone loss was 2.56 mm (SD 3.65 mm) in the BBG-D group and 1.71 mm (SD 4.11 mm) in the SWST group (P = 0.64). The mean probing pocket depth was within sound limits in both groups without significant differences (P > 0.05). Bleeding on probing was low.
CONCLUSIONS


Within the limitations of this study, a similar implant survival rate was observed between the BBG-D and SWST techniques during the 5-year follow-up. The buccopalatal bone width decreased over time regardless of the augmentation method used.",2019,The buccopalatal bone width significantly (P < 0.001) decreased over time regardless of the study group.,"['Thirteen patients in the BBG-D group and seven in the SWST group could be included in the analysis', 'Thirty patients with a buccopalatal bone width of ≤ 3 mm']","['Lateral alveolar ridge augmentation with autogenous block grafts fixed at a distance vs resorbable poly-D-L-lactide foil fixed', 'autogenous bone block grafts fixed at a distance (BBG-D) versus a resorbable poly-D-L-lactide foil fixed at a distance (SonicWeld Rx shell technique [SWST', 'BBG-D and SWST']","['implant survival rate', 'mean probing pocket depth', 'implant survival, changes in bone morphology visualised', 'mean buccal bone loss', 'buccopalatal bone width']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0002387', 'cui_str': 'Alveolar Ridge Augmentation'}, {'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0071417', 'cui_str': 'poly(d(G-m5C))'}, {'cui': 'C0293984', 'cui_str': 'lactide'}, {'cui': 'C1293164', 'cui_str': 'Bone block'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}]",30.0,0.120213,The buccopalatal bone width significantly (P < 0.001) decreased over time regardless of the study group.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Korsch', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kasprzyk', 'Affiliation': ''}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Walther', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bartols', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
2537,31535102,Stability evaluation of implants placed in the atrophic maxilla using osteotome sinus floor elevation with and without bone grafting: A 5-year prospective study.,"PURPOSE


Osteotome sinus floor elevation (OSFE) is a technique aimed at simplifying implant placement in the posterior atrophic maxilla. The necessity of bone grafting under the elevated sinus membrane has been widely debated. The aim was to compare the evolution over 5 years of implant stability in sites grafted or left ungrafted.
MATERIALS AND METHODS


A total of 12 patients (9 female and 3 male) presenting ≤ 4 mm initial bone height (IBH) in the posterior maxillary sites were recruited. Implants (n = 37) were placed using OSFE. According to the randomisation, the sinuses received either bone graft (n = 20, control group) or no graft (n = 17, test group). Patients received both these treatments when both sinuses fulfilled the inclusion criteria. Control assessments were performed 1 week, 10 weeks, 12 weeks, and then 1 year, 3 years and 5 years after the implant placement. Periapical radiographs were taken and the implant stability quotient (ISQ) was measured at different time points.
RESULTS


At implant surgery, the mean ISQ was 58.9 ± 11.2 for the test group and 53.8 ± 10.2 for the control group; it plummeted 10 weeks after the implant placement and rose thereafter. Five years after the implant placement, the mean ISQ reached 80.8 ± 4.2 for the control group, and 79.7 ± 4.3 for the test group. The difference between the groups was not significant. The IBH significantly affected implant stability at implant insertion and 5 years after the implant insertion, but not at the other time points.
CONCLUSIONS


The implants performed using OSFE in ungrafted sites were as stable as the implants placed in grafted sites.",2019,"The IBH significantly affected implant stability at implant insertion and 5 years after the implant insertion, but not at the other time points.
","['posterior atrophic maxilla', '12 patients (9 female and 3 male) presenting ≤ 4 mm initial bone height (IBH) in the posterior maxillary sites were recruited']","['osteotome sinus floor elevation with and without bone grafting', 'bone graft (n = 20, control group) or no graft']","['implant stability', 'mean ISQ', 'implant stability quotient (ISQ']","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0182092', 'cui_str': 'Osteotome (physical object)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0016249', 'cui_str': 'Floors'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.039602,"The IBH significantly affected implant stability at implant insertion and 5 years after the implant insertion, but not at the other time points.
","[{'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Merheb', 'Affiliation': ''}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Nurdin', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bischof', 'Affiliation': ''}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Gimeno-Rico', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Quirynen', 'Affiliation': ''}, {'ForeName': 'Rabah', 'Initials': 'R', 'LastName': 'Nedir', 'Affiliation': ''}]","International journal of oral implantology (Berlin, Germany)",[]
2538,32430272,Diagnostic efficacy of three suction techniques for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions: protocol for a multicenter randomized cross-over clinical trial.,"BACKGROUND


How suction technique affects endoscopic ultrasound-guided tissue acquisition (EUS-TA) remains unclear. A standardized protocol is currently lacking, with most previous studies being restricted to EUS-guided fine-needle aspiration (EUS-FNA). The research related to EUS-guided fine-needle biopsy (EUS-FNB) is sparse.
AIMS


The aim of this study is to evaluate the diagnostic efficacy, cellularity, tissue acquisition, blood contamination and adverse event rate of three common suction techniques (standard suction, slow-pull, and wet suction) used for EUS-FNB of solid pancreatic masses.
METHODS


This is a multicenter single-blind randomized cross-over superiority trial. A total of 300 patients with suspected pancreatic malignancy will be enrolled from digestive endoscopic centers at five large tertiary hospitals in China. All three suction techniques will be performed on each patient using a 25G ProCore needle, with the sequence of suction techniques determined by randomization. Cytological and histological specimens obtained with each of the three techniques will be assessed independently. Outcomes among the three suction techniques will be compared.
DISCUSSION


To the best of our knowledge, this is the largest multicenter randomized cross-over trial designed to determine the optimal suction technique for the diagnosis of solid pancreatic masses. This study may contribute to standardizing the suction technique for EUS-FNB.",2020,"All three suction techniques will be performed on each patient using a 25G ProCore needle, with the sequence of suction techniques determined by randomization.",['300 patients with suspected pancreatic malignancy will be enrolled from digestive endoscopic centers at five large tertiary hospitals in China'],"['endoscopic ultrasound-guided fine-needle biopsy', 'three common suction techniques (standard suction, slow-pull, and wet suction']","['diagnostic efficacy, cellularity, tissue acquisition, blood contamination and adverse event rate', 'Diagnostic efficacy']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0205381', 'cui_str': 'Wet'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",300.0,0.0776443,"All three suction techniques will be performed on each patient using a 25G ProCore needle, with the sequence of suction techniques determined by randomization.","[{'ForeName': 'Shi-Yu', 'Initials': 'SY', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Southwest Medical University, Southwest Medical University, Luzhou, Sichuan Province, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Department of Gastroenterology, Wuhan Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei Province, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': ""Department of Gastroenterology, Shenzhen People's Hospital, Second Clinical Medical Sciences of Jinan University, Shenzhen, Guangdong Province, China.""}, {'ForeName': 'Yue-Ping', 'Initials': 'YP', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Qingdao University, Medical College of Qingdao University, Qingdao, Shandong Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Pathology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Pathology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China.'}, {'ForeName': 'Zhen-Dong', 'Initials': 'ZD', 'LastName': 'Jin', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China. Electronic address: zhendjin@126.com.'}, {'ForeName': 'Kai-Xuan', 'Initials': 'KX', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University /Naval Medical University, Shanghai, China. Electronic address: wangkaixuan224007@163.com.'}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.03.026']
2539,32017867,A pragmatic trial of a group intervention in senior housing communities to increase resilience.,"BACKGROUND


Aging is associated with numerous stressors that negatively impact older adults' well-being. Resilience improves ability to cope with stressors and can be enhanced in older adults. Senior housing communities are promising settings to deliver positive psychiatry interventions due to rising resident populations and potential impact of delivering interventions directly in the community. However, few intervention studies have been conducted in these communities. We present a pragmatic stepped-wedge trial of a novel psychological group intervention intended to improve resilience among older adults in senior housing communities.
DESIGN


A pragmatic modified stepped-wedge trial design.
SETTING


Five senior housing communities in three states in the US.
PARTICIPANTS


Eighty-nine adults over age 60 years residing in independent living sector of senior housing communities.
INTERVENTION


Raise Your Resilience, a manualized 1-month group intervention that incorporated savoring, gratitude, and engagement in value-based activities, administered by unlicensed residential staff trained by researchers. There was a 1-month control period and a 3-month post-intervention follow-up.
MEASUREMENTS


Validated self-report measures of resilience, perceived stress, well-being, and wisdom collected at months 0 (baseline), 1 (pre-intervention), 2 (post-intervention), and 5 (follow-up).
RESULTS


Treatment adherence and satisfaction were high. Compared to the control period, perceived stress and wisdom improved from pre-intervention to post-intervention, while resilience improved from pre-intervention to follow-up. Effect sizes were small in this sample, which had relatively high baseline resilience. Physical and mental well-being did not improve significantly, and no significant moderators of change in resilience were identified.
CONCLUSION


This study demonstrates feasibility of conducting pragmatic intervention trials in senior housing communities. The intervention resulted in significant improvement in several measures despite ceiling effects. The study included several features that suggest high potential for its implementation and dissemination across similar communities nationally. Future studies are warranted, particularly in samples with lower baseline resilience or in assisted living facilities.",2020,"Compared to the control period, perceived stress and wisdom improved from pre-intervention to post-intervention, while resilience improved from pre-intervention to follow-up.","['senior housing communities to increase resilience', 'senior housing communities', 'Eighty-nine adults over age 60 years residing in independent living sector of senior housing communities', 'Five senior housing communities in three states in the US', 'older adults in senior housing communities', 'older adults']",['novel psychological group intervention'],"['Validated self-report measures of resilience, perceived stress, well-being, and wisdom collected']","[{'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021189', 'cui_str': 'Independent Living'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",89.0,0.0653045,"Compared to the control period, perceived stress and wisdom improved from pre-intervention to post-intervention, while resilience improved from pre-intervention to follow-up.","[{'ForeName': 'Emily B H', 'Initials': 'EBH', 'LastName': 'Treichler', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Glorioso', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Tsung-Chin', 'Initials': 'TC', 'LastName': 'Wu', 'Affiliation': 'Sam and Rose Stein Institute for Research on Aging, University of California San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Xin M', 'Initials': 'XM', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Daly', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, San Diego, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': ""O'Brien"", 'Affiliation': 'Mather Institute, Evanston, IL, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Smith', 'Affiliation': 'Mather Institute, Evanston, IL, USA.'}, {'ForeName': 'Dilip V', 'Initials': 'DV', 'LastName': 'Jeste', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, San Diego, CA, USA.'}]",International psychogeriatrics,['10.1017/S1041610219002096']
2540,21050387,Four-year follow-up of a randomized controlled trial of a social support intervention on infant feeding practices.,"In a 4-year follow-up of a randomized controlled trial, this study aimed to evaluate the longer-term effects of a peer-led infant feeding intervention that was delivered during the first year of life. The original intervention used monthly home visits from trained volunteers to improve infant feeding practices among a sample of low-income mothers in two disadvantaged London boroughs. Outcome measures at follow-up included children's eating and drinking habits, general and dental health, and BMI. Data were collected via structured face-to-face interviews and postal questionnaires. Of 212 women who completed the original trial, 101 took part in the follow-up (55 intervention, 46 control). Children's mean age at follow-up was 4 years 7 months. There is little evidence that the intervention had an important effect on children's current BMI, caries levels or consumption of fruit and vegetables. However, mothers from the intervention group had better nutritional knowledge and confidence. Intervention group children also consumed more pure fruit juice [relative risk (RR) = 1.57; 95% confidence interval (CI) 0.99, 2.49] and were more likely to never drink squash (RR = 1.76; 95% CI 1.20, 2.58). The data suggest that the original peer support intervention had a small number of positive long-term effects.",2010,The original intervention used monthly home visits from trained volunteers to improve infant feeding practices among a sample of low-income mothers in two disadvantaged London boroughs.,"[""Children's mean age at follow-up was 4 years 7 months"", '212 women who completed the original trial, 101 took part in the follow-up (55 intervention, 46 control', 'infant feeding practices']","['original intervention used monthly home visits from trained volunteers to improve infant feeding practices', 'peer-led infant feeding intervention', 'social support intervention']","[""children's eating and drinking habits, general and dental health, and BMI"", 'pure fruit juice [relative risk (RR) ', ""children's current BMI, caries levels or consumption of fruit and vegetables"", 'nutritional knowledge and confidence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0037438'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0556303', 'cui_str': 'Drinking habits (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0452453', 'cui_str': 'Fruit Juices'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}]",212.0,0.11793,The original intervention used monthly home visits from trained volunteers to improve infant feeding practices among a sample of low-income mothers in two disadvantaged London boroughs.,"[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Scheiwe', 'Affiliation': 'Department of Epidemiology and Public Health, UCL, London WC1E 6BT, UK. a.scheiwe@ucl.ac.uk'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hardy', 'Affiliation': ''}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Watt', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2009.00231.x']
2541,31499227,Health coaching to improve self-care of informal caregivers of adults with chronic heart failure - iCare4Me: Study protocol for a randomized controlled trial.,"BACKGROUND


Persons with chronic heart failure are living longer. These patients typically live in the community and are cared for at home by informal caregivers. These caregivers are an understudied and stressed group.
METHODS


We are conducting a two-arm, randomized controlled trial of 250 caregivers of persons with chronic heart failure to evaluate the efficacy of a health coaching intervention. A consecutive sample of participants is being enrolled from both clinic and hospital settings at a single institution affiliated with a large medical center in the northeastern US. Both the intervention and control groups receive tablets programmed to provide standardized health information. In addition, the intervention group receives 10 live coaching sessions delivered virtually by health coaches using the tablets. The intervention is evaluated at 6-months, with self-care as the primary outcome. Cost-effectiveness of the intervention is evaluated at 12-months. We are also enrolling heart failure patients (dyads) whenever possible to explore the effect of caregiver outcomes (self-care, stress, coping, health status) on heart failure patient outcomes (number of hospitalizations and days in the hospital) at 12-months.
DISCUSSION


We expect the proposed study to require 5 years for completion. If shown to be efficacious and cost-effective, our virtual health coaching intervention can easily be scaled to. support millions of caregivers worldwide.",2019,"If shown to be efficacious and cost-effective, our virtual health coaching intervention can easily be scaled to.","['informal caregivers of adults with chronic heart failure - iCare4Me', 'enrolling heart failure patients (dyads', '250 caregivers of persons with chronic heart failure', 'patients typically live in the community and are cared for at home by informal caregivers', 'Persons with chronic heart failure', 'A consecutive sample of participants is being enrolled from both clinic and hospital settings at a single institution affiliated with a large medical center in the northeastern US']","['Health coaching', 'health coaching intervention', '10 live coaching sessions delivered virtually by health coaches using the tablets']",['Cost-effectiveness'],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",250.0,0.082201,"If shown to be efficacious and cost-effective, our virtual health coaching intervention can easily be scaled to.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'University of Pennsylvania, United States of America. Electronic address: briegel@nursing.upenn.edu.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Hanlon', 'Affiliation': 'Virginia Technical University, United States of America.'}, {'ForeName': 'Norma B', 'Initials': 'NB', 'LastName': 'Coe', 'Affiliation': 'University of Pennsylvania, United States of America.'}, {'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Hirschman', 'Affiliation': 'University of Pennsylvania, United States of America.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Thomas', 'Affiliation': 'University of Pennsylvania, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stawnychy', 'Affiliation': 'University of Pennsylvania, United States of America.'}, {'ForeName': 'Joyce W', 'Initials': 'JW', 'LastName': 'Wald', 'Affiliation': 'Hospital of the University of Pennsylvania, United States of America.'}, {'ForeName': 'Kathryn H', 'Initials': 'KH', 'LastName': 'Bowles', 'Affiliation': 'University of Pennsylvania, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105845']
2542,31243156,Stepped-wedge randomised trial to evaluate population health intervention designed to increase appropriate anticoagulation in patients with atrial fibrillation.,"BACKGROUND


Clinical guidelines recommend anticoagulation for patients with atrial fibrillation (AF) at high risk of stroke; however, studies report 40% of this population is not anticoagulated.
OBJECTIVE


To evaluate a population health intervention to increase anticoagulation use in high-risk patients with AF.
METHODS


We used machine learning algorithms to identify patients with AF from electronic health records at high risk of stroke (CHA 2 DS 2 -VASc risk score ≥2), and no anticoagulant prescriptions within 12 months. A clinical pharmacist in the anticoagulation service reviewed charts for algorithm-identified patients to assess appropriateness of initiating an anticoagulant. The pharmacist then contacted primary care providers of potentially undertreated patients and offered assistance with anticoagulation management. We used a stepped-wedge design, evaluating the proportion of potentially undertreated patients with AF started on anticoagulant therapy within 28 days for clinics randomised to intervention versus usual care.
RESULTS


Of 1727 algorithm-identified high-risk patients with AF in clinics at the time of randomisation to intervention, 432 (25%) lacked evidence of anticoagulant prescriptions in the prior year. After pharmacist review, only 17% (75 of 432) of algorithm-identified patients were considered potentially undertreated at the time their clinic was randomised to intervention. Over a third (155 of 432) were excluded because they had a single prior AF episode (transient or provoked by serious illness); 36 (8%) had documented refusal of anticoagulation, the remainder had other reasons for exclusion. The intervention did not increase new anticoagulant prescriptions (intervention: 4.1% vs usual care: 4.0%, p=0.86).
CONCLUSIONS


Algorithms to identify underuse of anticoagulation among patients with AF in healthcare databases may not capture clinical subtleties or patient preferences and may overestimate the extent of undertreatment. Changing clinician behaviour remains challenging.",2019,"The intervention did not increase new anticoagulant prescriptions (intervention: 4.1% vs usual care: 4.0%, p=0.86).
","['high-risk patients with AF', 'patients with atrial fibrillation', 'undertreated patients with AF started on', 'patients with AF in healthcare databases', 'patients with AF from electronic health records at high risk of stroke (CHA 2 DS 2 -VASc risk score ≥2), and no anticoagulant prescriptions within 12 months', 'patients with atrial fibrillation (AF) at high risk of stroke', 'Over a third (155 of 432) were excluded because they had a single prior AF episode (transient or provoked by serious illness); 36 (8%) had documented refusal of anticoagulation, the remainder had other reasons for exclusion']","['anticoagulant therapy', 'population health intervention', 'machine learning algorithms']",['new anticoagulant prescriptions'],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}]","[{'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}, {'cui': 'C3242284', 'cui_str': 'Population Health'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0002045'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",432.0,0.0649514,"The intervention did not increase new anticoagulant prescriptions (intervention: 4.1% vs usual care: 4.0%, p=0.86).
","[{'ForeName': 'Shirley V', 'Initials': 'SV', 'LastName': 'Wang', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA swang1@bwh.harvard.edu.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Rogers', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Yinzhu', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'DeiCicchi', 'Affiliation': ""Anticoagulation Services, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Dejene', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': ""Anticoagulation Services, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Division of General Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Fischer', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}]",BMJ quality & safety,['10.1136/bmjqs-2019-009367']
2543,31248548,Rivaroxaban Plus Aspirin Versus Aspirin in Relation to Vascular Risk in the COMPASS Trial.,"BACKGROUND


The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial showed that the combination of low-dose rivaroxaban and aspirin reduced major vascular events in patients with stable vascular disease.
OBJECTIVES


The purpose of this study was to identify subsets of patients at higher risk of recurrent vascular events, which may help focus the use of rivaroxaban and aspirin therapy.
METHODS


COMPASS patients with vascular disease were risk stratified using 2 methods: the REACH (REduction of Atherothrombosis for Continued Health) atherothrombosis risk score and CART (Classification and Regression Tree) analysis. The absolute risk differences for rivaroxaban with aspirin were compared to aspirin alone over 30 months for the composite of cardiovascular death, myocardial infarction, stroke, acute limb ischemia, or vascular amputation; for severe bleeding; and for the net clinical benefit.
RESULTS


High-risk patients using the REACH score were those with 2 or more vascular beds affected, history of heart failure (HF), or renal insufficiency, and by CART analysis were those with ≥2 vascular beds affected, history of HF, or diabetes. Rivaroxaban and aspirin combination reduced the serious vascular event incidence by 25% (4.48% vs. 5.95%, hazard ratio: 0.75; 95% confidence interval: 0.66 to 0.85), equivalent to 23 events prevented per 1,000 patients treated for 30 months, at the cost of a nonsignificant 34% increase in severe bleeding (1.34; 95% confidence interval: 0.95 to 1.88), or 2 events caused per 1,000 patients treated. Among patients with ≥1 high-risk feature identified from the CART analysis, rivaroxaban and aspirin prevented 33 serious vascular events, whereas in lower-risk patients, rivaroxaban and aspirin treatment led to the avoidance of 10 events per 1,000 patients treated for 30 months.
CONCLUSIONS


In patients with vascular disease, further risk stratification can identify higher-risk patients (≥2 vascular beds affected, HF, renal insufficiency, or diabetes). The net clinical benefit remains favorable for most patients treated with rivaroxaban and aspirin compared with aspirin.",2019,"Rivaroxaban and aspirin combination reduced the serious vascular event incidence by 25% (4.48% vs. 5.95%, hazard ratio: 0.75; 95% confidence interval: 0.66 to 0.85), equivalent to 23 events prevented per 1,000 patients treated for 30 months, at the cost of a nonsignificant 34% increase in severe bleeding (1.34; 95% confidence interval: 0.95 to 1.88), or 2 events caused per 1,000 patients treated.","['patients with vascular disease', 'COMPASS patients with vascular disease', 'patients with stable vascular disease']","['rivaroxaban and aspirin therapy', 'Rivaroxaban Plus Aspirin Versus Aspirin', 'Rivaroxaban and aspirin', 'rivaroxaban with aspirin', 'aspirin', 'rivaroxaban', 'rivaroxaban and aspirin']","['severe bleeding', 'history of heart failure (HF), or renal insufficiency', 'REACH (REduction of Atherothrombosis for Continued Health) atherothrombosis risk score and CART', 'serious vascular events', 'serious vascular event incidence', 'cardiovascular death, myocardial infarction, stroke, acute limb ischemia, or vascular amputation; for severe bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C4303556', 'cui_str': 'Aspirin therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1963943', 'cui_str': 'Atherothrombosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0179636', 'cui_str': 'Cart'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4049535', 'cui_str': 'Acute limb ischaemia'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}]",,0.100593,"Rivaroxaban and aspirin combination reduced the serious vascular event incidence by 25% (4.48% vs. 5.95%, hazard ratio: 0.75; 95% confidence interval: 0.66 to 0.85), equivalent to 23 events prevented per 1,000 patients treated for 30 months, at the cost of a nonsignificant 34% increase in severe bleeding (1.34; 95% confidence interval: 0.95 to 1.88), or 2 events caused per 1,000 patients treated.","[{'ForeName': 'Sonia S', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'Department of Medicine, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: anands@mcmaster.ca.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Department of Medicine, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Department of Statistics, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Bosch', 'Affiliation': 'School of Rehabilitative Science, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Neumann', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Widimsky', 'Affiliation': 'Department of Cardiology, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Alvaro A', 'Initials': 'AA', 'LastName': 'Avezum', 'Affiliation': 'Research Division, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'Department of Medicine and Cardiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cook Bruns', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Center for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Centre, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Department of Medicine, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Department of Medicine, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.02.079']
2544,31288901,Comparison of efficacy and safety of ilaprazole and esomeprazole both in initial treatment regimen and retreatment regimen of Helicobacter pylori infection in chronic gastritis.,"The aim of this study was to compare the efficacy and safety of ilaprazole and esomeprazole both in initial treatment regimen and retreatment regimen of H. pylori infection in chronic gastritis and to explore risk factors for eradication failure. A total of 330 patients with chronic gastritis who were confirmed of H. pylori infection were enrolled in this study. 290 of them were initially treated patients and the 40 remained were patients with retreatment. Eradication assessment was performed at least four weeks after the completion of eradication therapy. Results showed that the eradication rates of the ilaprazole group and esomeprazole group were 91.4 % and 88.4 % for per-protocol (PP) analysis (p=0.41) and 89.0 % and 86.2 % for intention-to-treat (ITT) analysis (p=0.48) in initially treated patients. Meanwhile, they were 75.0 % and 72.2 % for PP analysis (p=0.85) and 75.0 % and 70.0 % for ITT analysis (p=0.72) in patients with retreatment. The differences were not statistically significant. There was also no significant difference in safety between the two drugs. A multiple logistic regression analysis showed that demographic factors such as age, gender, alcohol, smoking, coronary heart disease (CHD), hypertension (HTN) and diabetes mellitus (DM) did not affect eradication rates. However, patients with higher DOB values and patients with atrophic gastritis had significantly lower eradication rates than patients with lower DOB values and with non-atrophic gastritis whether the proton pump inhibitor (PPI) in eradication regimens was ilaprazole or esomeprazole. In conclusion, our findings suggest that the efficacy and safety of ilaprazole and esomeprazole were not significantly different both in initial treatment regimen and retreatment regimen of H. pylori infection in chronic gastritis and DOB values and type of chronic gastritis were to be independent risk factors for eradication failure. In addition, we discovered that a new quadruple regimen containing furazolidone and minocycline which achieved good efficacy and safety can be a promising option for retreatment of H. pylori infection.",2019,Results showed that the eradication rates of the ilaprazole group and esomeprazole group were 91.4 % and 88.4 % for per-protocol (PP) analysis (p=0.41) and 89.0 % and 86.2 % for intention-to-treat (ITT) analysis (p=0.48) in initially treated patients.,"['chronic gastritis', '330 patients with chronic gastritis who were confirmed of H. pylori infection']","['esomeprazole', 'furazolidone and minocycline', 'ilaprazole and esomeprazole']","['chronic gastritis and DOB values and type of chronic gastritis', 'demographic factors such as age, gender, alcohol, smoking, coronary heart disease (CHD), hypertension (HTN) and diabetes mellitus (DM', 'safety', 'efficacy and safety', 'eradication rates']","[{'cui': 'C0085695', 'cui_str': 'Chronic gastritis'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0016855', 'cui_str': 'Furazolidone'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C1881129', 'cui_str': 'ilaprazole'}]","[{'cui': 'C0085695', 'cui_str': 'Chronic gastritis'}, {'cui': 'C0421451', 'cui_str': 'Date of birth'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011292', 'cui_str': 'Demographic Factors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",330.0,0.0289299,Results showed that the eradication rates of the ilaprazole group and esomeprazole group were 91.4 % and 88.4 % for per-protocol (PP) analysis (p=0.41) and 89.0 % and 86.2 % for intention-to-treat (ITT) analysis (p=0.48) in initially treated patients.,"[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Shuhong', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jianmei', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Yue', 'Affiliation': ''}, {'ForeName': 'Guoshan', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Dongxue', 'Initials': 'D', 'LastName': 'Yao', 'Affiliation': ''}, {'ForeName': 'Qiuzhi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ''}]",Die Pharmazie,['10.1691/ph.2019.9349']
2545,31332655,"Effect of a Therapeutic Strategy Guided by Lung Ultrasound on 6-Month Outcomes in Patients with Heart Failure: Randomized, Multicenter Trial (EPICC Study).","INTRODUCTION AND OBJECTIVES


Pulmonary congestion (PC) is associated with an increased risk of hospitalization and death in patients with heart failure (HF). Lung ultrasound has shown to be highly sensitive for detecting PC in HF. The aim of this study is to evaluate whether lung ultrasound-guided therapy improves 6-month outcomes in patients with HF compared with conventional treatment.
MATERIALS AND METHODS


Randomized, multicenter, single-blind clinical trial in patients discharged from Internal Medicine Departments after hospitalization for decompensated HF. Participants will be assigned 1:1 to receive treatment guided according to the presence of lung ultrasound signs of congestion (semi-quantitative evaluation of B lines and the presence of pleural effusion) versus clinical assessment of congestion. The primary outcome is the combination of cardiovascular death and readmission for HF at 6 months.
CONCLUSIONS


The results of this study will provide more evidence about the impact of lung ultrasound on treatment monitoring in patients with chronic HF.",2019,Pulmonary congestion (PC) is associated with an increased risk of hospitalization and death in patients with heart failure (HF).,"['patients with chronic HF', 'patients with HF compared with conventional treatment', 'Patients with Heart Failure', 'patients with heart failure (HF', 'patients discharged from Internal Medicine Departments after hospitalization for decompensated HF']","['lung ultrasound-guided therapy', 'Therapeutic Strategy Guided by Lung Ultrasound']","['combination of cardiovascular death and readmission for HF at 6\xa0months', 'Pulmonary congestion (PC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205434', 'cui_str': 'Decompensated (qualifier value)'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242073', 'cui_str': 'Pulmonary congestion (disorder)'}]",,0.14203,Pulmonary congestion (PC) is associated with an increased risk of hospitalization and death in patients with heart failure (HF).,"[{'ForeName': 'Manuel Méndez', 'Initials': 'MM', 'LastName': 'Bailón', 'Affiliation': 'Internal Medicine Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria (IDISSC), Facultad de Medicina, Universidad Complutense, Avda. Prof. Martin Lago S/N, 28040, Madrid, Spain. manuel.mendez@salud.madrid.org.'}, {'ForeName': 'Jose María Cepeda', 'Initials': 'JMC', 'LastName': 'Rodrigo', 'Affiliation': 'Internal Medicine Department, Hospital Vega Baja, Orihuela, Spain.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Lorenzo-Villalba', 'Affiliation': 'Internal Medicine Department, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Jose Manuel', 'Initials': 'JM', 'LastName': 'Cerqueiro', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Jose Curbelo', 'Initials': 'JC', 'LastName': 'García', 'Affiliation': 'Internal Medicine Department, Hospital Universitario La Princesa, Madrid, Spain.'}, {'ForeName': 'Elpidio Calvo', 'Initials': 'EC', 'LastName': 'Manuel', 'Affiliation': 'Internal Medicine Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria (IDISSC), Facultad de Medicina, Universidad Complutense, Avda. Prof. Martin Lago S/N, 28040, Madrid, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Martín-Sánchez', 'Affiliation': 'Emergency Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Ramon Bover', 'Initials': 'RB', 'LastName': 'Freire', 'Affiliation': 'Cardiology Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Pilar Cubo', 'Initials': 'PC', 'LastName': 'Romano', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Infanta Cristina, Parla, Madrid, Spain.'}, {'ForeName': 'Luis Manzano', 'Initials': 'LM', 'LastName': 'Espinosa', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Jose Carlos', 'Initials': 'JC', 'LastName': 'Arévalo-Lorido', 'Affiliation': 'Internal Medicine Department, Hospital de Zafra, Zafra, Badajoz, Spain.'}, {'ForeName': 'Jose Manuel Casas', 'Initials': 'JMC', 'LastName': 'Rojo', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Infanta Cristina, Parla, Madrid, Spain.'}, {'ForeName': 'Juan Torres', 'Initials': 'JT', 'LastName': 'Macho', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Infanta Cristina, Parla, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular drugs and therapy,['10.1007/s10557-019-06891-z']
2546,32430334,Polygenic risk for skin autoimmunity impacts immune checkpoint blockade in bladder cancer.,"PD-1 and PD-L1 act to restrict T cell responses in cancer and contribute to self-tolerance. Consistent with this role, PD-1 checkpoint inhibitors have been associated with immune-related adverse events (irAEs), immune toxicities thought to be autoimmune in origin. Analyses of dermatological irAEs have identified an association with improved overall survival (OS) following anti-PD-(L)1 therapy, but the factors that contribute to this relationship are poorly understood. We collected germline whole-genome sequencing data from IMvigor211, a recent phase 3 randomized controlled trial comparing atezolizumab (anti-PD-L1) monotherapy to chemotherapy in bladder cancer. We found that high vitiligo, high psoriasis, and low atopic dermatitis polygenic risk scores (PRSs) were associated with longer OS under anti-PD-L1 monotherapy as compared to chemotherapy, reflecting the Th17 polarization of these diseases. PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures. Shared genetic factors impact risk for dermatological autoimmunity and anti-PD-L1 monotherapy in bladder cancer.",2020,"PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures.",['bladder cancer'],['atezolizumab (anti-PD-L1) monotherapy'],"['overall survival (OS', 'low atopic dermatitis polygenic risk scores (PRSs']","[{'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0526833,"PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures.","[{'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Khan', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Di Nucci', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Kwan', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hammer', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Mariathasan', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Rouilly', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carroll', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Fontes', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Ley Acosta', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Guardino', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Haiyin', 'Initials': 'H', 'LastName': 'Chen-Harris', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Bhangale', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Mellman', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Experimental Cancer Medicine Centre, Barts Cancer Institute, Queen Mary University of London, EC1M 6BQ London, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hunkapiller', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'G Scott', 'Initials': 'GS', 'LastName': 'Chandler', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Albert', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1922867117']
2547,31305950,Effects of a Mindfulness Activity on Nursing Service Staff Perceptions of Caring Behaviors in the Workplace.,"Research on caring in nurse-to-nurse relationships is not extensive, but studies have shown that health care workers can experience incivility in the workplace and unhealthy relationships can increase stress and influence nurse retention. The current study examined nurse perceptions of caring in the workplace and the effect of a mindfulness activity. A mixed method design was used, and data were collected on 164 nursing staff members after a 1-minute mindfulness activity. Pre- and post-survey growth in caring behavior indicated a statistically significant positive effect for the treatment group. Qualitative reports showed that after completing a mindfulness activity, staff members were more focused, and willing to set a good example, off er help to others, and encourage a positive overall work environment. Mindfulness activities can improve nurse-to-nurse caring and reduce incivility in the workplace. [Journal of Psychosocial Nursing and Mental Health Services, 57(11), 28-36.].",2019,Pre- and post-survey growth in caring behavior indicated a statistically significant positive effect for the treatment group.,"['Nursing Service Staff Perceptions of Caring Behaviors in the Workplace', '164 nursing staff members after a 1-minute mindfulness activity']",['Mindfulness Activity'],[],"[{'cui': 'C0028697', 'cui_str': 'Nursing service'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",[],164.0,0.0132645,Pre- and post-survey growth in caring behavior indicated a statistically significant positive effect for the treatment group.,"[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Rossetti', 'Affiliation': ''}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Raison', 'Affiliation': ''}, {'ForeName': 'Deana', 'Initials': 'D', 'LastName': 'Gallegos', 'Affiliation': ''}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Gorman', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Moscatel', 'Affiliation': ''}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Smyth', 'Affiliation': ''}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': ''}]",Journal of psychosocial nursing and mental health services,['10.3928/02793695-20190626-01']
2548,31495294,Morningness-eveningness scores predict outcomes differentially for depressed patients attending morning vs. afternoon day treatment streams.,"At the Center for Addiction and Mental Health (CAMH) Integrated Day Treatment (IDT) program, each patient attends either a morning stream or an afternoon stream, but not both. We examined whether subjective chronotype, or the time of day an individual prefers to be most active and alert, predicted treatment outcomes differentially in depressed patients attending the morning vs. afternoon IDT streams. The Horne-Östberg Morningness-Eveningness Questionnaire (MEQ) was administered before IDT treatment to 203 consecutive patients experiencing a major depressive episode. Multiple regression was used to predict change in depression and quality of life scores based on treatment stream (morning or afternoon), baseline MEQ scores and the treatment stream by MEQ interaction. The treatment stream by MEQ interaction was a highly significant predictor of both depression and quality of life change scores. Post-hoc analyses based on established MEQ categories revealed that definite evening chronotypes had significantly better responses in the morning stream than did morning chronotypes, and significantly worse responses in the afternoon stream relative to moderate evening or neutral chronotypes. There were insufficient morning chronotypes in the afternoon stream to assess clinical responses for this subgroup. In the morning stream only, there was a significant positive correlation between the change in MEQ scores after four weeks of IDT treatment (i.e. a shift to greater morningness) and the decrease in depression scores (r = .36,  p  = .003), consistent with a therapeutic phase advance in circadian rhythms. In sum, these preliminary data suggest that definite evening chronotypes may have the greatest relative benefit from attending the morning vs. afternoon IDT stream. As patients currently select which IDT stream they will attend, future work based on randomized treatment assignment and using passive actigraphy to assess circadian phase is currently planned to extend these preliminary findings.",2019,"Multiple regression was used to predict change in depression and quality of life scores based on treatment stream (morning or afternoon), baseline MEQ scores and the treatment stream by MEQ interaction.","['depressed patients attending the morning vs. afternoon IDT streams', '203 consecutive patients experiencing a major depressive episode']",['Horne-Östberg Morningness-Eveningness Questionnaire (MEQ'],"['depression and quality of life scores based on treatment stream (morning or afternoon), baseline MEQ scores', 'Addiction and Mental Health (CAMH', 'depression and quality of life change scores', 'MEQ scores', 'depression scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439152', 'cui_str': 'milliequivalent'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442540', 'cui_str': 'Streams'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0439152', 'cui_str': 'milliequivalent'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",203.0,0.0281357,"Multiple regression was used to predict change in depression and quality of life scores based on treatment stream (morning or afternoon), baseline MEQ scores and the treatment stream by MEQ interaction.","[{'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Levitan', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health , Toronto , Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Klein', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health , Toronto , Canada.'}, {'ForeName': 'Neely', 'Initials': 'N', 'LastName': 'Bakshi', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health , Toronto , Canada.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Laposa', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health , Toronto , Canada.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Hill', 'Affiliation': 'Department of Physiology, University of Toronto , Toronto , Canada.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kloiber', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health , Toronto , Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health , Toronto , Canada.'}]",Chronobiology international,['10.1080/07420528.2019.1661851']
2549,20977661,Iodine status in pregnancy and household salt iodine content in rural Bangladesh.,"Adequate maternal iodine intake is essential during pregnancy for the development of the foetus. To assess the extent of iodine insufficiency and its association with household iodized salt in rural Bangladesh, we measured urinary iodine and household salt iodine content among pregnant women in early (≤16 weeks, n = 1376) and late (≥32 weeks, n = 1114) pregnancy. Salt (∼20 g) and a spot urine sample (∼10 mL) were collected from women participating in a randomized, placebo-controlled trial of vitamin A or beta-carotene supplementation in rural northwestern Bangladesh during home visits in early and late pregnancy. Salt iodine was analyzed by iodometric titration, and urinary iodine by the Ohashi method. Almost all salt samples had some detectable iodine, but over 75% contained <15 ppm. Median (interquartile range) urinary iodine concentrations were 66 (34-133) and 55 (28-110) µg L⁻¹ in early and late pregnancy, respectively; urinary iodine <150 µg L⁻¹ was found in ∼80% of women at both times in pregnancy. Although the risk of iodine insufficiency declined with increasing iodine content of household salt (P for trend <0.05), median urinary iodine did not reach 150 µg L⁻¹ until iodine in household salt was at least 32 ppm and 51 ppm during early and late pregnancy, respectively. Despite a national policy on universal salt iodization, salt iodine content remains insufficient to maintain adequate maternal iodine status throughout pregnancy in rural northern Bangladesh. Alternative measures like direct iodine supplementation during pregnancy could be considered to assure adequate iodine status during this high-risk period of life.",2012,"Although the risk of iodine insufficiency declined with increasing iodine content of household salt (P for trend <0.05), median urinary iodine did not reach 150 µg L⁻¹ until iodine in household salt was at least 32 ppm and 51 ppm during early and late pregnancy, respectively.","['pregnant women in early (≤16 weeks, n = 1376) and late (≥32 weeks, n = 1114) pregnancy', 'rural northwestern Bangladesh during home visits in early and late pregnancy', 'rural northern Bangladesh', 'rural Bangladesh']","['vitamin A or beta-carotene supplementation', 'placebo', 'Salt iodine']","['median urinary iodine', 'Median (interquartile range) urinary iodine concentrations']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}]","[{'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0053396', 'cui_str': 'betacarotene'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",1376.0,0.0245118,"Although the risk of iodine insufficiency declined with increasing iodine content of household salt (P for trend <0.05), median urinary iodine did not reach 150 µg L⁻¹ until iodine in household salt was at least 32 ppm and 51 ppm during early and late pregnancy, respectively.","[{'ForeName': 'Abu Ahmed', 'Initials': 'AA', 'LastName': 'Shamim', 'Affiliation': 'The JiVitA Maternal and Child Research Project, Godown Road, Gaibandha-5700, Gaibandha, Bangladesh.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Christian', 'Affiliation': ''}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Schulze', 'Affiliation': ''}, {'ForeName': 'Hasmot', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': ''}, {'ForeName': 'Alamgir', 'Initials': 'A', 'LastName': 'Kabir', 'Affiliation': ''}, {'ForeName': 'Mahbubur', 'Initials': 'M', 'LastName': 'Rashid', 'Affiliation': ''}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Labrique', 'Affiliation': ''}, {'ForeName': 'Qauzi', 'Initials': 'Q', 'LastName': 'Salamatullah', 'Affiliation': ''}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'West', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2010.00282.x']
2550,30024215,Evaluating the effectiveness and implementation of evidence-based treatment: A multisite hybrid design.,"The gap between treatment development and efficacy testing to scaled up implementations of evidence-based treatment (EBT) is an estimated 20 years, and hybrid research designs aim to reduce the gap. One was used for a multisite study in cancer control, testing coprimary aims: (a) determine the feasibility and utility of a flexible EBT implementation strategy and (b) determine the clinical effectiveness of an EBT as implemented by newly trained providers. Therapists from 15 diverse sites implemented the biobehavioral intervention (BBI) for cancer patients ( N  = 158) as part of standard care. For implementation, therapists determined treatment format, number of sessions, and so forth and reported session-by-session fidelity. Patients completed fidelity and outcome assessments. Results showed therapists BBI implementation was done with fidelity, for example, session ""dose"" (59%), core content coverage (60-70%), and others. Patient reported fidelity was favorable and comparable to the BBI efficacy trial. Effectiveness data show the primary outcome, patients' scores on the Profile of Mood States total mood disturbance, significantly improved ( R ² = 0.06, β = -0.24,  p  < .01) as did a secondary outcome, physical activity ( R ² = 0.02, β = 0.13,  p  < .05). This first use of a hybrid design in health psychology provided support for a novel strategy that allowed providers implementation flexibility. Still, the EBT was delivered with fidelity and in addition, therapists generated novel procedures to enhance setting-specific usage of BBI and its ultimate effectiveness with patients. This research is an example of translational research spanning theory and efficacy tests to dissemination and implementation. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,Therapists from 15 diverse sites implemented the biobehavioral intervention (BBI) for cancer patients ( N  = 158) as part of standard care.,"['newly trained providers', 'cancer patients ( N  = 158) as part of standard care']","['EBT', 'flexible EBT implementation strategy', 'biobehavioral intervention (BBI']","['Profile of Mood States total mood disturbance', 'physical activity']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0484993,Therapists from 15 diverse sites implemented the biobehavioral intervention (BBI) for cancer patients ( N  = 158) as part of standard care.,"[{'ForeName': 'Jamile A', 'Initials': 'JA', 'LastName': 'Ashmore', 'Affiliation': 'Center for Medical Psychology.'}, {'ForeName': 'Kirk W', 'Initials': 'KW', 'LastName': 'Ditterich', 'Affiliation': 'Department of Patient and Family Support Services.'}, {'ForeName': 'Claire C', 'Initials': 'CC', 'LastName': 'Conley', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Wright', 'Affiliation': ""Gilda's Club Quad Cities.""}, {'ForeName': 'Peggy S', 'Initials': 'PS', 'LastName': 'Howland', 'Affiliation': 'East Alabama Medical Center.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Huggins', 'Affiliation': 'Wellness House.'}, {'ForeName': 'Jena', 'Initials': 'J', 'LastName': 'Cooreman', 'Affiliation': 'Department of Supportive Oncology.'}, {'ForeName': 'Priscilla S', 'Initials': 'PS', 'LastName': 'Andrews', 'Affiliation': 'Cancer Wellness Center.'}, {'ForeName': 'Donald R', 'Initials': 'DR', 'LastName': 'Nicholas', 'Affiliation': 'Department of Counseling Psychology, Social Psychology and Counseling.'}, {'ForeName': 'Lind', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': ""Providence St. John's Cancer Center.""}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Hewitt', 'Affiliation': 'Department of Pediatric Psychosocial Oncology.'}, {'ForeName': 'Joan N', 'Initials': 'JN', 'LastName': 'Scales', 'Affiliation': 'Psych-Oncology Services.'}, {'ForeName': 'Jenny K', 'Initials': 'JK', 'LastName': 'Delap', 'Affiliation': 'Psych-Oncology Services.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Gray', 'Affiliation': 'Independent Practice.'}, {'ForeName': 'Lynelle A', 'Initials': 'LA', 'LastName': 'Tyler', 'Affiliation': 'Patient and Family Support Services.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Collins', 'Affiliation': 'Department of Adult Psychology and Behavioral Medicine.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Whiting', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Brothers', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Marlena M', 'Initials': 'MM', 'LastName': 'Ryba', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Andersen', 'Affiliation': 'Department of Psychology.'}]",The American psychologist,['10.1037/amp0000309']
2551,30577048,The Forced Active Buckling Sign: A New Clinical Test for the Diagnosis of ACL Insufficiency.,"Although insufficiency of the anterior cruciate ligament (ACL) is a frequent result of an injury, validated tests are associated with unsatisfying validity. Moreover, some of these tests are not easy to perform and patient's muscular resistance often limits their reliability. Therefore, with this study, we want to design an accurate test to diagnose an ACL insufficiency, which is independent of the assessor's skills and overcome any muscular resistance. Fifty patients with an isolated ACL rupture (group A; age 26.4 years ± 14.9 standard deviation [SD]; female,  n  = 15) and additional 50 patients with an intact ACL but meniscal lesions (group B; age 45.4 years ± 12.9 SD; female,  n  = 23) were consecutively included in this study. The integrity of the ACL and the menisci were evaluated by magnetic resonance imaging and verified arthroscopically. Two orthopaedic surgeons performed a pivot shift test, a Lachman's test, and our new ""forced active buckling"" (FAB)-sign test in all patients. The surgeons were blinded for the pathology of the knee and we randomized the tests for each patient and examiner. The sensitivity, specificity, positive predictive value, negative predictive value, and positive and negative likelihood ratios with confidence intervals were calculated and compared. With a prevalence of 0.5, the FAB-sign test revealed the best overall sensitivity of 0.78 compared with the Lachman's and pivot shift tests of 0.74 and 0.46, respectively. Also, the overall specificity of the FAB-sign test of 0.95 was higher than the Lachman's test of 0.83, however, comparable to the pivot shift test of 0.96. The FAB-sign test demonstrated the best positive and negative predictive values of 0.94 and 0.81. There was no significant difference between the two examiners concerning the accuracy of results in each test ( p  = 0.83). This study shows that the introduced FAB-sign test can detect an ACL insufficiency more sensitive and more specific compared to the pivot shift and Lachman's tests in the subacute phase. This is a randomized controlled diagnostic study, level 1b.",2020,There was no significant difference between the two examiners concerning the accuracy of results in each test ( p  = 0.83).,"['Fifty patients with an isolated ACL rupture (group A; age 26.4 years\u2009±\u200914.9 standard deviation [SD]; female,  n \u2009=\u200915) and additional 50 patients with an intact ACL but meniscal lesions (group B; age 45.4 years\u2009±\u200912.9 SD; female,  n \u2009=\u200923', 'anterior cruciate ligament (ACL']","['Forced Active Buckling Sign', 'pivot shift test, a Lachman\'s test, and our new ""forced active buckling"" (FAB)-sign test']","['sensitivity, specificity, positive predictive value, negative predictive value, and positive and negative likelihood ratios with confidence intervals', 'overall specificity of the FAB-sign test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C3669378', 'cui_str': 'Pivot shift test'}, {'cui': 'C0231752', 'cui_str': 'Lachman test response'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021031', 'cui_str': 'Immunoglobulin, F(ab) fragment'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",50.0,0.0272,There was no significant difference between the two examiners concerning the accuracy of results in each test ( p  = 0.83).,"[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Blanke', 'Affiliation': 'Department of Orthopedic Sports Medicine and Arthroscopic Surgery, Hessing Stiftung Augsburg, Augsburg, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Haenle', 'Affiliation': 'Department of Orthopedic Sports Medicine and Arthroscopic Surgery, Hessing Stiftung Augsburg, Augsburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Feitenhansl', 'Affiliation': 'Department of Orthopedic Sports Medicine and Arthroscopic Surgery, Hessing Stiftung Augsburg, Augsburg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Vogt', 'Affiliation': 'Department of Orthopedic Sports Medicine and Arthroscopic Surgery, Hessing Stiftung Augsburg, Augsburg, Germany.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Camathias', 'Affiliation': ""Department of Orthopedic Surgery, University Children's Hospital Basel (UKBB), Basel, Switzerland.""}]",The journal of knee surgery,['10.1055/s-0038-1676351']
2552,20929499,Effects of a lifestyle modification trial among phenotypically obese metabolically normal and phenotypically obese metabolically abnormal adolescents in comparison with phenotypically normal metabolically obese adolescents.,"This study aimed to assess the effects of a 2-month lifestyle modification trial on cardio-metabolic abnormalities and C-reactive protein (CRP) among obese adolescents with metabolic syndrome [phenotypically obese metabolically abnormal (POMA)] and obese adolescents without a cardio-metabolic disorder [phenotypically obese metabolically normal (POMN)], as well as in normal-weight adolescents with at least one cardio-metabolic disorder [phenotypically normal metabolically obese (PNMO)]. The study comprised 360 adolescents assigned in three groups of equal number of POMN, POMA and PNMO. They were enrolled in a trial consisting of aerobic activity classes, diet and behaviour modification, and were recalled after 6 months. Overall, 94.7% of participants completed the 2-month trial, and 87.3% of them returned after 6 months. The mean CRP was not significantly different between the POMA and PNMO groups, but was higher than in the POMN group. After the trial, body mass index (BMI) and waist circumference (WC) decreased in obese participants, and the mean body fat mass decreased in all groups. At 2 months, the mean total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG) and CRP decreased in the POMA and PNMO groups. After 2 and 6 months, the decrease in mean TC, LDL-C, TG, CRP and systolic blood pressure was greater in the POMA than in the POMN group. The magnitude of decrease in CRP correlated with that of BMI, WC, fat mass, TG, TC and LDL-C. Lifestyle modification programmes for primordial/primary prevention of chronic diseases would be beneficial at the population level and should not be limited to obese children.",2010,"After 2 and 6 months, the decrease in mean TC, LDL-C, TG, CRP and systolic blood pressure was greater in the POMA than in the POMN group.","['obese adolescents with metabolic syndrome [phenotypically obese metabolically abnormal (POMA)] and obese adolescents without a cardio-metabolic disorder [phenotypically obese metabolically normal (POMN', 'normal-weight adolescents with at least one cardio-metabolic disorder [phenotypically normal metabolically obese (PNMO', '360 adolescents assigned in three groups of equal number of POMN, POMA and PNMO', 'phenotypically obese metabolically normal and phenotypically obese metabolically abnormal adolescents in comparison with phenotypically normal metabolically obese adolescents']",['C-reactive protein (CRP'],"['mean body fat mass', 'CRP', 'body mass index (BMI) and waist circumference (WC', 'mean CRP', 'mean total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG) and CRP', 'mean TC, LDL-C, TG, CRP and systolic blood pressure']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0025517', 'cui_str': 'Thesaurismosis'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1098057', 'cui_str': 'poly(n-octyl methacrylate)'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",360.0,0.0461101,"After 2 and 6 months, the decrease in mean TC, LDL-C, TG, CRP and systolic blood pressure was greater in the POMA than in the POMN group.","[{'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Kelishadi', 'Affiliation': 'Pediatric Preventive Cardiology Department, Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences, Iran. kroya@aap.net'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Hashemipour', 'Affiliation': ''}, {'ForeName': 'Nizal', 'Initials': 'N', 'LastName': 'Sarrafzadegan', 'Affiliation': ''}, {'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Mohammadifard', 'Affiliation': ''}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Alikhasy', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Beizaei', 'Affiliation': ''}, {'ForeName': 'Firouzeh', 'Initials': 'F', 'LastName': 'Sajjadi', 'Affiliation': ''}, {'ForeName': 'Parinaz', 'Initials': 'P', 'LastName': 'Poursafa', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Amin', 'Affiliation': ''}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Ghatreh-Samani', 'Affiliation': ''}, {'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Khavarian', 'Affiliation': ''}, {'ForeName': 'Zahra Dana', 'Initials': 'ZD', 'LastName': 'Siadat', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2009.00207.x']
2553,31350828,Therapeutic effect of early intensive antihypertensive treatment on rebleeding and perihematomal edema in acute intracerebral hemorrhage.,"To observe the effect of early intensive blood pressure (BP)-lowering treatment on rebleeding and perihematomal edema (PE) in patients with acute intracerebral hemorrhage (ICH). A total of 121 patients with ICH were randomly assigned to an early intensive antihypertensive treatment group (IG) (n = 62) or control group (CG) (n = 59). For both groups, 25 mg of urapidil injection was slowly administered intravenously in 6 hours of the onset. For the IG, 100 mg of urapidil and 30 mL of 0.9% sodium chloride were then slowly administered. Repeat computed tomography imaging was performed at 24 hours, 72 hours, day 7, and day 14 to detect any rebleeding via changes in hematoma volume and the changes in PE. Finally, NIHSS scores and Barthel Index (BI) were calculated at 24 hours, 72 hours, day 7, day 14, day 30, and day 90. The average hematoma volume in IG patients was significantly smaller than that of CG patients after 24 hours (P < .05). The volume of PE in the CG increased more than in the IG within 24 hours of onset, but was not statistically significant (P > .05); however, this trend was statistically significant after 72 hours (P < .05). On day 30 and day 90, the average NIHSS score of IG patients was lower than that of CG patients, and the BI was higher (P < .05) than that of CG patients. There was no significant difference in mortality between the two groups. Early intensive antihypertensive treatment in ICH patients reduces rebleeding and PE, improving short-term quality of life.",2019,The average hematoma volume in IG patients was significantly smaller than that of CG patients after 24 hours (P < .05).,"['121 patients with ICH', 'patients with acute intracerebral hemorrhage (ICH', 'acute intracerebral hemorrhage']","['Repeat computed tomography imaging', 'intensive antihypertensive treatment group (IG) (n\xa0=\xa062) or control group (CG', 'urapidil and 30\xa0mL of 0.9% sodium chloride', 'urapidil injection', 'early intensive blood pressure (BP)-lowering treatment']","['rebleeding and perihematomal edema (PE', 'rebleeding and PE, improving short-term quality of life', 'mortality', 'average hematoma volume', 'average NIHSS score', 'NIHSS scores and Barthel Index (BI', 'rebleeding and perihematomal edema', 'volume of PE in the CG']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0729619', 'cui_str': 'Computed tomography imaging - action (qualifier value)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0077857', 'cui_str': 'urapidil'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}]",121.0,0.0352209,The average hematoma volume in IG patients was significantly smaller than that of CG patients after 24 hours (P < .05).,"[{'ForeName': 'Yanjing', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'Department of Geriatric, The Second Hospital of Baoding City, Baoding, China.'}, {'ForeName': 'Chenhao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, The Second Hospital of Baoding City, Baoding, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, The Second Hospital of Baoding City, Baoding, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Geriatric, The Second Hospital of Baoding City, Baoding, China.'}, {'ForeName': 'Hongxuan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, The Second Hospital of Baoding City, Baoding, China.'}, {'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, The Second Hospital of Baoding City, Baoding, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Department of Geriatric, The Second Hospital of Baoding City, Baoding, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Gu', 'Affiliation': ""Fifth Department of Internal Medicine, Baoding Children's Hospital, Baoding, China.""}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13629']
2554,32430395,Thrombolysis with alteplase 3-4.5 hours after acute ischaemic stroke: trial reanalysis adjusted for baseline imbalances.,"OBJECTIVES


Alteplase is commonly recommended for acute ischaemic stroke within 4.5 hours after stroke onset. The Third European Cooperative Acute Stroke Study (ECASS III) is the only trial reporting statistically significant efficacy for clinical outcomes for alteplase use 3-4.5 hours after stroke onset. However, baseline imbalances in history of prior stroke and stroke severity score may confound this apparent finding of efficacy. We reanalysed the ECASS III trial data adjusting for baseline imbalances to determine the robustness or sensitivity of the efficacy estimates.
DESIGN


Reanalysis of randomised placebo-controlled trial. We obtained access to the ECASS III trial data and replicated the previously reported analyses to confirm our understanding of the data. We adjusted for baseline imbalances using multivariable analyses and stratified analyses and performed sensitivity analysis for missing data.
SETTING


Emergency care.
PARTICIPANTS


821 adults with acute ischaemic stroke who could be treated 3-4.5 hours after symptom onset.
INTERVENTIONS


Intravenous alteplase (0.9 mg/kg of body weight) or placebo.
MAIN OUTCOME MEASURES


The original primary efficacy outcome was modified Rankin Scale (mRS) score 0 or 1 (ie, being alive without any disability) and the original secondary efficacy outcome was a global outcome based on a composite of functional end points, both at 90 days. Adjusted analyses were only reported for the primary efficacy outcome and the original study protocol did not specify methods for adjusted analyses. Our adjusted reanalysis included these outcomes, symptom-free status (mRS 0), dependence-free status (mRS 0-2), mortality (mRS 6) and change across the mRS 0-6 spectrum at 90 days; and mortality and symptomatic intracranial haemorrhage at 7 days.
RESULTS


We replicated previously reported unadjusted analyses but discovered they were based on a modified interpretation of the National Institutes of Health Stroke Scale (NIHSS) score. The secondary efficacy outcome was no longer significant using the original NIHSS score. Previously reported adjusted analyses could only be replicated with significant effects for the primary efficacy outcome by using statistical approaches not reported in the trial protocol or statistical analysis plan. In analyses adjusting for baseline imbalances, all efficacy outcomes were not significant, but increases in symptomatic intracranial haemorrhage remained significant.
CONCLUSIONS


Reanalysis of the ECASS III trial data with multiple approaches adjusting for baseline imbalances does not support any significant benefits and continues to support harms for the use of alteplase 3-4.5 hours after stroke onset. Clinicians, patients and policymakers should reconsider interpretations and decisions regarding management of acute ischaemic stroke that were based on ECASS III results.
TRIAL REGISTRATION NUMBER


NCT00153036.",2020,"In analyses adjusting for baseline imbalances, all efficacy outcomes were not significant, but increases in symptomatic intracranial haemorrhage remained significant.
","['Emergency care', '821 adults with acute ischaemic stroke who could be treated 3-4.5\u2009hours after symptom onset']","['Intravenous alteplase', 'placebo']","['original NIHSS score', 'Health Stroke Scale (NIHSS) score', 'symptomatic intracranial haemorrhage', 'modified Rankin Scale (mRS) score 0 or 1 (ie, being alive without any disability', 'symptom-free status (mRS 0), dependence-free status (mRS 0-2), mortality (mRS 6) and change across the mRS 0-6 spectrum at 90 days; and mortality and symptomatic intracranial haemorrhage']","[{'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0436342', 'cui_str': 'Free of symptoms'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",821.0,0.293191,"In analyses adjusting for baseline imbalances, all efficacy outcomes were not significant, but increases in symptomatic intracranial haemorrhage remained significant.
","[{'ForeName': 'Brian Scott', 'Initials': 'BS', 'LastName': 'Alper', 'Affiliation': 'Medical Knowledge Office, EBSCO Information Services, Ipswich, Massachusetts, USA balper@ebsco.com.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Foster', 'Affiliation': ""Biostatistics, St Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': ""Biostatistics, St Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rae-Grant', 'Affiliation': 'DynaMed, EBSCO Health, Ipswich, Massachusetts, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Malone-Moses', 'Affiliation': 'Innovations and Evidence-Based Medicine Development, EBSCO Health, Ipswich, Massachusetts, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Manheimer', 'Affiliation': 'Innovations and Evidence-Based Medicine Development, EBSCO Health, Ipswich, Massachusetts, USA.'}]",BMJ evidence-based medicine,['10.1136/bmjebm-2020-111386']
2555,32430340,Long-term effect of YAG laser iridotomy on corneal endothelium in primary angle closure suspects: a 72-month randomised controlled study.,"PURPOSES


To evaluate the effect of YAG laser peripheral iridotomy (LPI) on corneal endothelial cell density (ECD) and morphology in primary angle closure suspects (PACS) over 72 months.
METHODS


The Zhongshan Angle Closure Prevention Trial is a single-centre randomised controlled trial. Subjects with bilateral PACS received YAG LPI prophylactic treatment in one eye randomly, while the fellow eye served as control. Central corneal ECD and morphology were assessed using non-contact specular microscopy (SP-2000P, Topcon) at baseline, 6, 18, 36, 54 and 72 months postoperatively. Mixed model analysis was conducted to compare the difference between treated and fellow eyes.
RESULTS


A total of 875 participants were included, with a mean age of 59.3±5.0 years and 83.5% female. The ECD declined significantly (p<0.001) over time in both treated and fellow eyes, but the treated eyes showed more progressive cell loss with increasing time (p<0.001). The difference in ECD loss between LPI-treated and fellow eyes was not significant at each follow-up until 72 months (4.9% in LPI eyes vs 4.2% in non-LPI eyes, p=0.003). Mean cell areas increased significantly over time in both treated and fellow eyes (p<0.001), but no longitudinal change was observed for hexagonality. In LPI-treated eyes, no significant correlation was found between age, gender, ocular biometrics, intraocular pressure and laser settings with endothelium change, except for time effect (p<0.01).
CONCLUSION


ECD decreases over time primarily due to ageing effect. YAG LPI does not appear to cause clinically significant corneal endothelial damage over 72 months after treatment.
TRIAL REGISTRATION NUMBER


ISRCTN45213099.",2020,"In LPI-treated eyes, no significant correlation was found between age, gender, ocular biometrics, intraocular pressure and laser settings with endothelium change, except for time effect (p<0.01).
","['primary angle closure suspects (PACS) over 72 months', 'Subjects with bilateral PACS received', 'primary angle closure suspects', 'A total of 875 participants were included, with a mean age of 59.3±5.0 years and 83.5% female']","['YAG laser iridotomy', 'YAG laser peripheral iridotomy (LPI', 'YAG LPI prophylactic']","['Mean cell areas', 'ECD loss', 'corneal endothelial damage', 'ECD', 'Central corneal ECD and morphology', 'progressive cell loss', 'age, gender, ocular biometrics, intraocular pressure and laser settings with endothelium change', 'corneal endothelium', 'corneal endothelial cell density (ECD) and morphology']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0429528', 'cui_str': 'Angle closure'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517897', 'cui_str': '875'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1261111', 'cui_str': 'YAG laser iridotomy'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0197497', 'cui_str': 'Anterior segment of eye incision'}, {'cui': 'C0395459', 'cui_str': 'Laser iridotomy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0014259', 'cui_str': 'Structure of corneal endothelium'}]",875.0,0.114353,"In LPI-treated eyes, no significant correlation was found between age, gender, ocular biometrics, intraocular pressure and laser settings with endothelium change, except for time effect (p<0.01).
","[{'ForeName': 'Chimei', 'Initials': 'C', 'LastName': 'Liao', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuzhen', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Moorfield Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Shengsong', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Tin', 'Initials': 'T', 'LastName': 'Aung', 'Affiliation': 'Singapore Eye Research Institute and Singapore National Eye Center, Singapore.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Foster', 'Affiliation': 'NIHR Biomedical Research Center at Moorfields Eye Hospital and UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Friedman', 'Affiliation': 'Massachusetts Eye and Ear, Harvard Medical School Department of Ophthalmology, Boston, Massachusetts, USA.'}, {'ForeName': 'Mingguang', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China mingguanghe@gmail.com.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2020-315811']
2556,32430373,Subjective Versus Objective Assessment of Cognitive Functioning in Primary Care.,"PURPOSE


This study examined the clinical utility of highly efficient subjective and objective screens of cognitive impairment.
METHOD


Participants ( N  = 124, age ≥ 65, mean = 73.59, SD = 6.26) completed a 2-item questionnaire of subjective memory functioning, a brief computerized cognitive test, and the Montreal Cognitive Assessment (MoCA). Next, participants were assigned to 1 of 4 conditions, based on their subjective (low/high) and objective (impaired/unimpaired) levels of cognitive functioning. Further analysis divided the sample into age-based groups (ie, age < 75, age ≥ 75).
RESULTS


The proportion of participants in the impaired subsample (ie, MoCA < 26), who reported a high level of subjective concern about their memory, was low (ie, 0.15). Among unimpaired participants, analysis detected significant group differences across subjective memory levels ( P  < .0003) and age ( P  < .005) categories on one of the three tasks of the computerized test (ie, cognitive control). In contrast, the MoCA offered no differentiation between these groups.
CONCLUSION


Screening protocols in which cognitive testing is administered subsequent to patient complaint are prone to underdiagnosis. In addition, common dementia screens are insensitive to subjective deficits and healthy cognitive aging. Therefore, they may lead to dismissing valid concerns that deserve preventive attention. Primary care needs efficient screening tools that are sensitive to prodromal decline.",2020,"Among unimpaired participants, analysis detected significant group differences across subjective memory levels ( P  < .0003) and age ( P  < .005) categories on one of the three tasks of the computerized test (ie, cognitive control).","['Participants ( N  = 124, age ≥ 65, mean = 73.59, SD = 6.26) completed a 2-item questionnaire of subjective memory functioning, a brief computerized cognitive test, and the Montreal Cognitive Assessment (MoCA', 'Further analysis divided the sample into age-based groups (ie, age < 75, age ≥ 75', 'Primary Care']",[],['subjective memory levels'],"[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0209543,"Among unimpaired participants, analysis detected significant group differences across subjective memory levels ( P  < .0003) and age ( P  < .005) categories on one of the three tasks of the computerized test (ie, cognitive control).","[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Hess', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL).'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Levy', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL). boaz.levy@umb.edu.'}, {'ForeName': 'Ardeshir Z', 'Initials': 'AZ', 'LastName': 'Hashmi', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL).'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Greenspan', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL).'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Elber', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL).'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Falcon', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL).'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Driscoll', 'Affiliation': 'From the Department of Counseling and School Psychology, University of Massachusetts, Boston, MA (CH, BL, JH, SG, AE, KF); Cleveland Clinic, Lerner College of Medicine, Ohio (AH); Tufts University School of Medicine, Boston, MA (DD); and McLean Hospital, Belmont, MA, Harvard Medical School (BL).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2020.03.190265']
2557,32430445,Patient-centred and economic effectiveness of a decision aid for patients with age-related cataract in China: study protocol of a randomised controlled trial.,"INTRODUCTION


The need for cataract surgery is on the rise due to our ageing population and high demands for greater visual functioning. Although the majority of patients want to participate in a shared decision-making process, no decision aid has been available to improve the quality of decision. The present study aims to determine whether a decision aid increases informed decision about cataract surgery.
METHODS AND ANALYSIS


A parallel randomised controlled trial (772 participants) will be conducted. The decision aid will be implemented among patients with any age-related cataract in Yuexiu District, which is socioeconomically representative of a major metropolitan region in Southern China. Participants will be randomly assigned to receive either a patient decision aid or a traditional booklet, and they will complete three surveys: (1) baseline assessment before the intervention (time point (T)1), 2 weeks (T2) and 1 year (T3) after the intervention. The control group receives a traditional booklet with standard general information developed by the National Eye Institute to help patients understand cataract, whereas the intervention group receives a patient decision aid that includes not only the standard general information, but also the quantitative risk information on the possible outcomes of cataract surgery as well as value clarification exercise. The primary study outcome is the informed decision, the percentage of patients who have adequate knowledge and demonstrate consistency between attitudes and intentions. Secondary outcomes include perceived importance of cataract surgery benefits/harms, decision conflict and confidence, anticipated regret and booklet utilisation and acceptability at 2 weeks, and surgical rates and a cost-utility estimate of the decision aid at 1 year.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Ethics Committee of Zhongshan Ophthalmic Center (reference number: 2019KYPJ090). Results will be published in peer-reviewed journals and presented at scientific meetings for academic audiences.
TRIAL REGISTRATION NUMBER


NCT03992807.",2020,"The decision aid will be implemented among patients with any age-related cataract in Yuexiu District, which is socioeconomically representative of a major metropolitan region in Southern China.","['patients with any age-related cataract in Yuexiu District, which is socioeconomically representative of a major metropolitan region in Southern China', '772 participants', 'patients with age-related cataract in China']","['patient decision aid or a traditional booklet, and they will complete three surveys: (1) baseline assessment before the intervention', 'traditional booklet with standard general information developed by the National Eye Institute to help patients understand cataract, whereas the intervention group receives a patient decision aid that includes not only the standard general information, but also the quantitative risk information on the possible outcomes of cataract surgery as well as value clarification exercise']","['perceived importance of cataract surgery benefits/harms, decision conflict and confidence, anticipated regret and booklet utilisation and acceptability at 2 weeks, and surgical rates and a cost-utility estimate of the decision aid at 1 year']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0205449', 'cui_str': '3'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0150401', 'cui_str': 'Values clarification'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0439234', 'cui_str': 'year'}]",772.0,0.141142,"The decision aid will be implemented among patients with any age-related cataract in Yuexiu District, which is socioeconomically representative of a major metropolitan region in Southern China.","[{'ForeName': 'Yingfeng', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China zhyfeng@mail.sysu.edu.cn.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Mingguang', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yizhi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.'}]",BMJ open,['10.1136/bmjopen-2019-032242']
2558,32430450,"Cannabidiol (CBD) and Δ 9 -tetrahydrocannabinol (THC) for chronic insomnia disorder ('CANSLEEP' trial): protocol for a randomised, placebo-controlled, double-blinded, proof-of-concept trial.","INTRODUCTION


Insomnia is a highly prevalent and costly condition that is associated with increased health risks and healthcare utilisation. Anecdotally, cannabis use is frequently reported by consumers to promote sleep. However, there is limited research on the effects of cannabis on sleep and daytime function in people with insomnia disorder using objective measures. This proof-of-concept study will evaluate the effects of a single dose of an oral cannabis-based medicine on sleep and daytime function in participants with chronic insomnia disorder.
METHODS AND ANALYSIS


A randomised, crossover, placebo-controlled, single-dose study design will be used to test the safety and efficacy of an oral oil solution ('ETC120') containing 10 mg Δ 9 -tetrahydrocannabinol (THC) and 200 mg cannabidiol (CBD) in 20 participants diagnosed with chronic insomnia disorder. Participants aged 35-60 years will be recruited over an 18-month period commencing August 2019. Each participant will receive both the active drug and matched placebo, in a counterbalanced order, during two overnight study assessment visits, with at least a 1-week washout period between each visit. The primary outcomes are total sleep time and wake after sleep onset assessed via polysomnography. In addition, 256-channel high-density electroencephalography and source modelling using structural brain MRI will be used to comprehensively examine brain activation during sleep and wake periods on ETC120 versus placebo. Next-day cognitive function, alertness and simulated driving performance will also be investigated.
ETHICS AND DISSEMINATION


Ethics approval was received from Bellberry Human Research Ethics Committee (2018-04-284). The findings will be disseminated in a peer-reviewed open-access journal and at academic conferences.
TRIAL REGISTRATION NUMBER


ANZCTRN12619000714189.",2020,"Each participant will receive both the active drug and matched placebo, in a counterbalanced order, during two overnight study assessment visits, with at least a 1-week washout period between each visit.","['20 participants diagnosed with chronic insomnia disorder', 'participants with chronic insomnia disorder', 'people with insomnia disorder', 'Participants aged 35-60 years will be recruited over an 18-month period commencing August 2019']","['Cannabidiol (CBD) and Δ 9 -tetrahydrocannabinol (THC', ""oral oil solution ('ETC120') containing 10\u2009mg Δ 9 -tetrahydrocannabinol (THC) and 200\u2009mg cannabidiol (CBD"", 'oral cannabis-based medicine', 'active drug and matched placebo', 'placebo']","['sleep and daytime function', 'safety and efficacy', 'total sleep time and wake after sleep onset assessed via polysomnography']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]",20.0,0.542876,"Each participant will receive both the active drug and matched placebo, in a counterbalanced order, during two overnight study assessment visits, with at least a 1-week washout period between each visit.","[{'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Suraev', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nathaniel S', 'Initials': 'NS', 'LastName': 'Marshall', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': ""D'Rozario"", 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Gordon', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Delwyn J', 'Initials': 'DJ', 'LastName': 'Bartlett', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wong', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Yee', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Irwin', 'Affiliation': 'Menzies Health Institute Queensland, School Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Jonathon C', 'Initials': 'JC', 'LastName': 'Arnold', 'Affiliation': 'The University of Sydney, Lambert Initiative for Cannabinoid Therapeutics, Sydney, New South Wales, Australia.'}, {'ForeName': 'Iain S', 'Initials': 'IS', 'LastName': 'McGregor', 'Affiliation': 'The University of Sydney, Lambert Initiative for Cannabinoid Therapeutics, Sydney, New South Wales, Australia.'}, {'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Hoyos', 'Affiliation': 'Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Sydney, New South Wales, Australia camilla.hoyos@sydney.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-034421']
2559,32430454,Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial.,"OBJECTIVE


To evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials.
DESIGN


Randomised controlled trial (RCT).
SETTING


BMJ Open 's quality improvement programme.
PARTICIPANTS


24 manuscripts describing RCTs.
INTERVENTIONS


We used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review.
OUTCOMES


The primary outcome is the number of adequately reported items (0-8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention.
RESULTS


Manuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min.
CONCLUSIONS


We demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability.
TRIAL REGISTRATION NUMBER


NCT03751878.",2020,"RESULTS


Manuscripts in the intervention group",['24 manuscripts describing RCTs'],['editorial intervention'],"['proportion of manuscripts', 'number of adequately reported items (0-8 scale']","[{'cui': 'C0600659', 'cui_str': 'Manuscripts'}]","[{'cui': 'C0282412', 'cui_str': 'Editorial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.116028,"RESULTS


Manuscripts in the intervention group","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blanco', 'Affiliation': 'Statistics and Operations Research Department, Universitat Politecnica de Catalunya, Barcelona, Spain david.blanco.tena@upc.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schroter', 'Affiliation': 'The BMJ, London, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Aldcroft', 'Affiliation': 'The BMJ, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moher', 'Affiliation': 'Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutron', 'Affiliation': 'Statistics and Operations Research Department, Universitat Politecnica de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Jamie J', 'Initials': 'JJ', 'LastName': 'Kirkham', 'Affiliation': 'Centre for Biostatistics, Manchester Academic Health Science Centre, Manchester University, Manchester, UK.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Cobo', 'Affiliation': 'Statistics and Operations Research Department, Universitat Politecnica de Catalunya, Barcelona, Spain.'}]",BMJ open,['10.1136/bmjopen-2020-036799']
2560,32430452,Protocol of a randomised controlled trial assessing the impact of physical activity on bone health in children with inflammatory bowel disease.,"INTRODUCTION


Low bone mineral density (BMD) is a frequent issue in children and adolescents with inflammatory bowel disease (IBD). Several studies in healthy populations have reported a positive impact of physical activity (PA) on bone health. Recently, an observational study in paediatric patients with IBD showed a significant positive relationship between daily PA and BMD. However, intervention studies investigating a causal relationship between PA and BMD are warranted to confirm these results. The aim of this randomised controlled trial will be to investigate the effect of a PA programme on BMD in paediatric patients with IBD.
METHODS AND ANALYSIS


This trial is a multicentre (four centres), randomised, controlled, blinded end-point study. Eighty children with IBD will be randomly assigned in a 1:1 ratio to receive a programme with adapted physical exercises (intervention group) or usual PA (control group) during a 9-month period. The primary outcome is the change from baseline at 9 months (the end of the study) in whole-body BMD assessed by dual-energy X-ray absorptiometry. Secondary efficacy outcomes include the changes from baseline at 9 months in: BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.
ETHICS AND DISSEMINATION


The study was approved by the Research Ethics Committee in France (Comité de Protection des Personnes, Sud-Ouest and Outre-Mer III, Bordeaux, France, No 2018/27). All procedures will be performed according to the ethical standards of the Helsinki Declaration of 1975, as revised in 2008, and the European Union's Guidelines for Good Clinical Practice. Written informed consent will be obtained from the parents or legal guardian and from the children. Research findings will be disseminated in peer-reviewed journals and scientific meetings.
TRIAL REGISTRATION NUMBER


NCT03774329.",2020,"Secondary efficacy outcomes include the changes from baseline at 9 months in: BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.
ETHICS AND DISSEMINATION


","['children and adolescents with inflammatory bowel disease (IBD', 'healthy populations', 'Eighty children with IBD', 'paediatric patients with IBD', 'children with inflammatory bowel disease']","['PA programme', 'programme with adapted physical exercises (intervention group) or usual PA (control group', 'Low bone mineral density (BMD', 'physical activity']","['BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.\nETHICS AND DISSEMINATION', 'bone health', 'whole-body BMD assessed by dual-energy X-ray absorptiometry']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0162370', 'cui_str': 'Trochanter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]",80.0,0.174414,"Secondary efficacy outcomes include the changes from baseline at 9 months in: BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.
ETHICS AND DISSEMINATION


","[{'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Vanhelst', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000 Lille, France, Lille, France jeremy.vanhelst@chru-lille.fr.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Coopman', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Department of Paediatrics, Lille University, Jeanne de Flandre Children's Hospital, Lille, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Univ. Lille, CHU Lille, ULR 2694 - METRICS: Evaluation des technologies de santé et des pratiques médicales, F-59000 Lille, France, Lille, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dupont', 'Affiliation': 'Department of Paediatrics, Caen University Hospital F 14000 Caen, France and Normandy University, Caen, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Bertrand', 'Affiliation': 'Pediatric Unit, Le Havre Hospital, Le Havre, France.'}, {'ForeName': 'Djamal', 'Initials': 'D', 'LastName': 'Djeddi', 'Affiliation': 'Department of Paediatrics, Amiens University Hospital and University of Amiens, Amiens, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Turck', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000 Lille, France, Lille, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Ley', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000 Lille, France, Lille, France.'}]",BMJ open,['10.1136/bmjopen-2019-036400']
2561,32430455,Evaluating the real-world implementation of the Family Nurse Partnership in England: protocol for a data linkage study.,"INTRODUCTION


Almost 20 000 babies are born to teenage mothers each year in England, with poorer outcomes for mothers and babies than among older mothers. A nurse home visitation programme in the USA was found to improve a wide range of outcomes for young mothers and their children. However, a randomised controlled trial in England found no effect on short-term primary outcomes, although cognitive development up to age 2 showed improvement. Our study will use linked routinely collected health, education and social care data to evaluate the real-world effects of the Family Nurse Partnership (FNP) on child outcomes up to age 7, with a focus on identifying whether the FNP works better for particular groups of families, thereby informing programme targeting and resource allocation.
METHODS AND ANALYSIS


We will construct a retrospective cohort of all women aged 13-24 years giving birth in English NHS hospitals between 2010 and 2017, linking information on mothers and children from FNP programme data, Hospital Episodes Statistics and the National Pupil Database. To assess the effectiveness of FNP, we will compare outcomes for eligible mothers ever and never enrolled in FNP, and their children, using two analysis strategies to adjust for measured confounding: propensity score matching and analyses adjusting for maternal characteristics up to enrolment/28 weeks gestation. Outcomes of interest include early childhood development, childhood unplanned hospital admissions for injury or maltreatment-related diagnoses and children in care. Subgroup analyses will determine whether the effect of FNP varied according to maternal characteristics (eg, age and education).
ETHICS AND DISSEMINATION


The Nottingham Research Ethics Committee approved this study. Mothers participating in FNP were supportive of our planned research. Results will inform policy-makers for targeting home visiting programmes. Methodological findings on the accuracy and reliability of cross-sectoral data linkage will be of interest to researchers.",2020,A nurse home visitation programme in the USA was found to improve a wide range of outcomes for young mothers and their children.,"['retrospective cohort of all women aged 13-24 years giving birth in English NHS hospitals between 2010 and 2017, linking information on mothers and children from FNP programme data, Hospital Episodes Statistics and the National Pupil Database', 'young mothers and their children', 'eligible mothers ever and never enrolled in FNP, and their children', 'Mothers participating in FNP were supportive of our planned research']","['FNP', 'Family Nurse Partnership (FNP']","['early childhood development, childhood unplanned hospital admissions for injury or maltreatment-related diagnoses and children in care', 'cognitive development']","[{'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0728735', 'cui_str': 'Child in care'}]",,0.099084,A nurse home visitation programme in the USA was found to improve a wide range of outcomes for young mothers and their children.,"[{'ForeName': 'Francesca L', 'Initials': 'FL', 'LastName': 'Cavallaro', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Gilbert', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wijlaars', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Eilis', 'Initials': 'E', 'LastName': 'Kennedy', 'Affiliation': 'Children, Young Adults and Families Directorate, Tavistock and Portman NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Swarbrick', 'Affiliation': 'Family Nurse Partnership National Unit, Tavistock and Portman NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van der Meulen', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Harron', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK k.harron@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-038530']
2562,31370950,Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction.,"BACKGROUND


Although heart failure with preserved ejection fraction (HFpEF) is considered a disease of the elderly, younger patients are not spared from this syndrome.
OBJECTIVES


This study therefore investigated the associations among age, clinical characteristics, and outcomes in patients with HFpEF.
METHODS


Using data on patients with left ventricular ejection fraction ≥45% from 3 large HFpEF trials (TOPCAT [Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function], I-PRESERVE [Irbesartan in Heart Failure With Preserved Systolic Function], and CHARM Preserved [Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity]), patients were categorized according to age: ≤55 years (n = 522), 56 to 64 years (n = 1,679), 65 to 74 years (n = 3,405), 75 to 84 years (n = 2,464), and ≥85 years (n = 398). This study compared clinical and echocardiographic characteristics, as well as mortality and hospitalization rates, mode of death, and quality of life across age categories.
RESULTS


Younger patients (age ≤55 years) with HFpEF were more often obese, nonwhite men, whereas older patients with HFpEF were more often white women with a higher prevalence of atrial fibrillation, hypertension, and chronic kidney disease (eGFR <60 ml/min/1.73 m 2 ). Despite fewer comorbidities, younger patients had worse quality of life compared with older patients (age ≥85 years). Compared with patients age ≤55 years, patients age ≥85 years had higher mortality (hazard ratio: 6.9; 95% confidence interval: 4.2 to 11.4). However, among patients who died, sudden death was, proportionally, the most common mode of death (p < 0.001) in patients age ≤55 years. In contrast, older patients (age ≥85 years) died more often from noncardiovascular causes (34% vs. 20% in patients age ≤55 years; p < 0.001).
CONCLUSIONS


Compared with the elderly, younger patients with HFpEF were less likely to be white, were more frequently obese men, and died more often of cardiovascular causes, particularly sudden death. In contrast, elderly patients with HFpEF had more comorbidities and died more often from noncardiovascular causes. (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function [TOPCAT]; NCT00094302; Irbesartan in Heart Failure With Preserved Systolic Function [I-PRESERVE]; NCT00095238; Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity [CHARM Preserved]; NCT00634712).",2019,"Compared with patients age ≤55 years, patients age ≥85 years had higher mortality (hazard ratio: 6.9;","['for Adults With Heart\xa0Failure and Preserved Systolic Function', 'Patients With Heart\xa0Failure With Preserved Ejection Fraction', 'patients with HFpEF', 'elderly patients with', 'Heart\xa0Failure', 'patients with left ventricular ejection fraction\xa0≥45% from 3 large', '≤55 years (n\xa0=\xa0522), 56 to 64 years (n\xa0=\xa01,679), 65 to 74 years (n\xa0=\xa03,405), 75 to 84 years (n\xa0=\xa02,464), and\xa0≥85 years (n\xa0=\xa0398', 'older patients (age\xa0≥85 years) died more often from noncardiovascular causes (34% vs. 20% in patients age', 'Younger patients (age\xa0≤55 years) with', 'patients were categorized according to age']","['HFpEF trials (TOPCAT [Aldosterone Antagonist Therapy', 'HFpEF', 'preserved ejection fraction (HFpEF', 'Candesartan Cilexetil', 'CHARM Preserved [Candesartan Cilexetil', 'Aldosterone Antagonist Therapy']","['quality of life', 'died, sudden death', 'Systolic Function', 'mortality and hospitalization rates, mode of death, and quality of life across age categories', 'atrial fibrillation, hypertension, and chronic kidney disease (eGFR', 'higher mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0527379', 'cui_str': 'Candesartan cilexetil'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0516109,"Compared with patients age ≤55 years, patients age ≥85 years had higher mortality (hazard ratio: 6.9;","[{'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Tromp', 'Affiliation': 'National Heart Centre Singapore and Duke-NUS Medical School, Singapore; Department of Cardiology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Medicine, University of Minnesota Medical School and VA Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Carson', 'Affiliation': 'Department of Cardiology, Washington VA Medical Center, Washington, DC.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Komajda', 'Affiliation': 'Department of Cardiology, Hospital Saint Joseph, Paris, France.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'McKelvie', 'Affiliation': 'Western University, London, Ontario, Canada.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg and National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnston Veterans Administration Medical Center, Charleston, South Carolina.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Internal Medicine-Cardiology, University of Michigan School of Medicine, Ann Arbor, Michigan.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore and Duke-NUS Medical School, Singapore; Department of Cardiology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. Electronic address: john.mcmurray@glasgow.ac.uk.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.05.052']
2563,31066486,A comparison of the efficacy and tolerability of topical agents used in facial Demodex treatment.,"BACKGROUND


Demodex spp. is the most common ectoparasite in humans. This parasite is believed to play a role in the etiology of many dermatological and ocular disorders.
AIM


The aim of this study was to compare the efficacy and tolerability of the sulfur-sodium sulfacetamide combination, crotamiton, and permethrin, which are three topical agents commonly used in Demodex treatment.
METHODS


A total of 28 patients with primary demodicosis and 44 patients with Rosacea + Demodex were included in the study. The pretreatment and post-treatment Demodex spp. counts, patient satisfaction, and erythema decrease rates were compared.
RESULTS


Analysis of the efficacy of these topical agents on Demodex revealed that all three significantly decreased the number of parasites. The patient satisfaction was higher in the sodium acetamide group than the 10% crotamiton and 5% permethrin groups, and clinical evaluation (erythema/ papulopustules and white plugs) was better in the sodium acetamide group than the other groups but no statistically significant difference was found in terms of patient satisfaction and clinical evaluation.
CONCLUSION


The sulfur-sodium combination, crotamiton, and permethrin are the three agents commonly used in the treatment of Demodex spp. and all significantly decreased the Demodex count. The three agents were similar in terms of tolerability. Our study needs to be supported with others on larger patient series.",2019,"The patient satisfaction was higher in the sodium acetamide group than the 10% crotamiton and 5% permethrin groups, and clinical evaluation (erythema/ papulopustules and white plugs) was better in the sodium acetamide group than the other groups but no statistically significant difference was found in terms of patient satisfaction and clinical evaluation.
",['28 patients with primary demodicosis and 44 patients with Rosacea\xa0+\xa0Demodex were included in the study'],"['sulfur-sodium sulfacetamide combination, crotamiton, and permethrin']","['counts, patient satisfaction, and erythema decrease rates', 'patient satisfaction and clinical evaluation', 'number of parasites', 'patient satisfaction', 'efficacy and tolerability', 'Demodex count', 'tolerability', 'Demodex']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0392666', 'cui_str': 'Infestation by Demodex'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C0323683', 'cui_str': 'Demodex'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038774', 'cui_str': 'Sulfur'}, {'cui': 'C0282356', 'cui_str': 'Sulfacetamide sodium'}, {'cui': 'C0056519', 'cui_str': 'crotamiton'}, {'cui': 'C0070455', 'cui_str': 'Permethrin'}]","[{'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0323683', 'cui_str': 'Demodex'}]",28.0,0.0260898,"The patient satisfaction was higher in the sodium acetamide group than the 10% crotamiton and 5% permethrin groups, and clinical evaluation (erythema/ papulopustules and white plugs) was better in the sodium acetamide group than the other groups but no statistically significant difference was found in terms of patient satisfaction and clinical evaluation.
","[{'ForeName': 'Gulbahar', 'Initials': 'G', 'LastName': 'Sarac', 'Affiliation': 'Department of Dermatology, Inonu University School of Medicine, Malatya, Turkey.'}]",Journal of cosmetic dermatology,['10.1111/jocd.12986']
2564,31327653,Rethinking results from the Japanese 23-valent pneumococcal polysaccharide vaccine randomized clinical trial.,"We review a previously published randomized clinical trial of 23-valent pneumococcal polysaccharide vaccine (PPSV23) that has been used extensively globally to support PPSV23 use among adults. We argue that serious issues with internal and external validity exist that affect the usefulness of these data when evaluating pneumococcal vaccines for the general adult population. As one example of internal data inconsistency, the values reported for the percent of all pneumonia cases due to pneumococcus and the vaccine efficacy (VE) for all cause pneumonia are mutually inconsistent, even based on unrealistically high values for PPSV23 VE against vaccine serotypes and the proportion of pneumococcal pneumonias due to vaccine serotypes.",2019,We argue that serious issues with internal and external validity exist that affect the usefulness of these data when evaluating pneumococcal vaccines for the general adult population.,[],['23-valent pneumococcal polysaccharide vaccine (PPSV23'],[],[],"[{'cui': 'C0305065', 'cui_str': 'Pneumococcal Polysaccharide Vaccine'}, {'cui': 'C0947642', 'cui_str': 'Pneumovax 23'}]",[],,0.137373,We argue that serious issues with internal and external validity exist that affect the usefulness of these data when evaluating pneumococcal vaccines for the general adult population.,"[{'ForeName': 'Bradford D', 'Initials': 'BD', 'LastName': 'Gessner', 'Affiliation': 'Pfizer Vaccines, Collegeville, PA, USA. Electronic address: Bradford.gessner@pfizer.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Theilacker', 'Affiliation': 'Pfizer Vaccines, Collegeville, PA, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Jodar', 'Affiliation': 'Pfizer Vaccines, Collegeville, PA, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.07.040']
2565,31476879,Diurnal and day-to-day variations in isometric and isokinetic strength.,"Time-of-day effects in strength performance have been extensively investigated due to their relevance in competitive sports. However, most studies use large measurement intervals making it difficult to monitor potential performance changes throughout the day. Furthermore, previous studies have exclusively focused on how the time of day affects strength on a group level and ignored the individual differences in the times of peak performance. Therefore, the main purpose of this study was to investigate the diurnal and day-to-day variations in isometric and isokinetic leg, arm and trunk strength over six different times of the day. Following a familiarization test, 19 trained males (age: 24.1 ± 2.5 years) performed isometric and isokinetic strength assessments at six different times of the day (7:00, 10:00, 13:00, 16:00, 19:00, and 21:00) with an isokinetic dynamometer. An eighth test session was performed at the same time of the day as the seventh test session to investigate the day-to-day variations and the difference between diurnal and day-to-day variations were compared. All tests were separated by at least 48 h. The start time for the first session was randomized. The mean maximum isometric leg strength was 5.85 ± 0.80 N.kg -1  and 4.99 ± 0.78 N.kg -1 at the peak and at the nadir of the day, respectively. The mean difference (95% CI) was 0.86 ± 0.47 N.kg -1  (0.62; 1.10) for the diurnal variation and 0.30 ± 0.42 N.kg -1  (0.09; 0.52) for the day-to-day variation. The mean maximum isometric arm strength was 1.68 ± 0.33 N.kg -1  at the peak and 1.46 ± 0.19 N.kg -1  at the nadir of the day, respectively. The mean difference (95% CI) was 0.21 ± 0.16 N.kg -1  (0.14; 0.29) for the diurnal variation and 0.06 ± 0.05 N.kg -1  (0.03; 0.08) for the day-to-day variation. The linear mixed-effects model showed little evidence for differences in isometric leg strength between the different times of the day (all  p -values >0.983). The present study demonstrated that diurnal variations in leg and arm strength are nearly three times higher than the day-to-day variations, but there was only little evidence for a time-of-day effect on a group level. The diurnal variations observed herein without time-of-day effects are suggestive that individuals achieve their peak performance at different times of the day. Therefore, performance tests should be carried out at the same time of the day to ensure comparability. Furthermore, depending on the difference between the time of competition and the time of peak performance, as well as the individual magnitude in diurnal variation, some athletes can have a clear disadvantage. Abbreviation : 95% CI, 95% confidence interval; SD, standard deviation; ICC, intraclass correlation coefficient.",2019,The mean maximum isometric leg strength was 5.85 ± 0.80,['19 trained males (age: 24.1 ± 2.5 years) performed'],['isometric and isokinetic strength assessments'],"['isometric and isokinetic leg, arm and trunk strength', 'mean maximum isometric arm strength', 'diurnal variations in leg and arm strength', 'time of competition and the time of peak performance', 'mean maximum isometric leg strength', 'isometric leg strength', 'isometric and isokinetic strength']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",,0.0329836,The mean maximum isometric leg strength was 5.85 ± 0.80,"[{'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Knaier', 'Affiliation': 'Department of Sport, Exercise and Health, Faculty of Medicine, University of Basel , Basel , Switzerland.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Infanger', 'Affiliation': 'Department of Sport, Exercise and Health, Faculty of Medicine, University of Basel , Basel , Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Cajochen', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel , Basel , Switzerland.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Schmidt-Trucksaess', 'Affiliation': 'Department of Sport, Exercise and Health, Faculty of Medicine, University of Basel , Basel , Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Faude', 'Affiliation': 'Department of Sport, Exercise and Health, Faculty of Medicine, University of Basel , Basel , Switzerland.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Roth', 'Affiliation': 'Department of Sport, Exercise and Health, Faculty of Medicine, University of Basel , Basel , Switzerland.'}]",Chronobiology international,['10.1080/07420528.2019.1658596']
2566,32430457,"Effects of an Electronic Software ""Prompt"" With Health Care Professional Training on Cardiovascular and Renal Complications in a Multiethnic Population With Type 2 Diabetes and Microalbuminuria (the GP-Prompt Study): Results of a Pragmatic Cluster-Randomized Trial.","OBJECTIVE


Tight, targeted control of modifiable cardiovascular risk factors can reduce cardiovascular complications and mortality in individuals with type 2 diabetes (T2DM) and microalbuminuria. The effects of using an electronic ""Prompt"" with a treatment algorithm to support a treat-to-target approach has not been tested in primary care.
RESEARCH DESIGN AND METHODS


A multicenter, cluster-randomized trial was conducted among primary care practices across Leicestershire, U.K. The primary outcome was the proportion of individuals achieving systolic and diastolic blood pressure (<130 and <80 mmHg, respectively) and total cholesterol (<3.5 mmol/L) targets at 24 months. Secondary outcomes included proportion of individuals with HbA 1c  <58 mmol/mol (<7.5%), changes in prescribing, change in the albumin-to-creatinine ratio, major adverse cardiovascular events, cardiovascular mortality, and coding accuracy.
RESULTS


A total of 2,721 individuals from 22 practices, mean age 63 years, 41% female, and 62% from black and minority ethnic groups completed 2 years of follow-up. There were no significant differences in the proportion of individuals achieving the composite primary outcome, although the proportion of individuals achieving the prespecified outcome of total cholesterol <4.0 mmol (odds ratio 1.24; 95% CI 1.05-1.47;  P  = 0.01) increased with intensive intervention compared with control. Coding for microalbuminuria increased relative to control (odds ratio 2.05; 95% CI 1.29-3.25;  P  < 0.01).
CONCLUSIONS


Greater improvements in composite cardiovascular risk factor control with this intervention compared with standard care were not achieved in this cohort of high-risk individuals with T2DM. However, improvements in lipid profile and coding can benefit patients with diabetes to alter the high risk of atherosclerotic cardiovascular events. Future studies should consider comprehensive strategies, including patient education and health care professional engagement, in the management of T2DM.",2020,"Coding for microalbuminuria increased relative to control (odds ratio 2.05; 95% CI 1.29-3.25;  P  < 0.01).
","['Multiethnic Population With Type 2 Diabetes and Microalbuminuria (the GP-Prompt Study', 'primary care practices across Leicestershire, U.K', '2,721 individuals from 22 practices, mean age 63 years, 41% female, and 62% from black and minority ethnic groups completed 2 years of follow-up', 'individuals with type 2 diabetes (T2DM) and microalbuminuria']","['Electronic Software ""Prompt"" With Health Care Professional Training']","['proportion of individuals with HbA 1c  <58 mmol/mol', 'total cholesterol', 'Cardiovascular and Renal Complications', 'changes in prescribing, change in the albumin-to-creatinine ratio, major adverse cardiovascular events, cardiovascular mortality, and coding accuracy', 'proportion of individuals achieving systolic and diastolic blood pressure', 'lipid profile', 'composite cardiovascular risk factor control']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0454863', 'cui_str': 'Leicestershire'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",2721.0,0.0749131,"Coding for microalbuminuria increased relative to control (odds ratio 2.05; 95% CI 1.29-3.25;  P  < 0.01).
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Willis', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Crasto', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dallosso', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Ghazala', 'Initials': 'G', 'LastName': 'Waheed', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Seidu', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K. kk22@le.ac.uk.'}]",Diabetes care,['10.2337/dc19-2243']
2567,32429965,Evaluation of integrated modular teaching in Chinese ophthalmology trainee courses.,"BACKGROUND


Before attending ophthalmology trainee courses in Zhongshan Ophthalmic Centre, the medical students from Sun Yat-sen University had finished two years of premedical education after the six-year medical courses including basic medical courses, clinical medical courses, clerkship, and research training in medical college. Integrated modular teaching using different problem-based teaching methods in ophthalmology was designed by the teaching steering committee of Zhongshan Ophthalmic Centre. This study aimed to evaluate the effectiveness and satisfaction scales of the integrated modular teaching among the trainee students.
METHODS


A total of 100 medical students attending ophthalmology trainee courses in Zhongshan Ophthalmic Centre were enrolled and randomly allocated into 4 groups according to the teaching arrangement. The trainee courses consisted of several sessions delivered in multiple methods, such as ""flipped classroom"" session and team-based learning session. The pre- and post-class tests were delivered to evaluate the effectiveness of the integrated modular teaching. The satisfaction survey questionnaire was collected from all participants to investigate the degree of satisfaction.
RESULTS


Compared with the first-day-test score, the total last-day-test score was significantly improved by a paired t-test (t = 3.288, P = 0.001). Nineteen students obtained a significant improvement in ranking increased by more than 10 in the last-day-test, whereas they failed to obtain a higher average score for daily performance than other students (t = 0.469, P = 0.654). According to the participant satisfaction questionnaires, these innovative teaching methods were considered as effective and satisfactory.
CONCLUSIONS


Integrated modular teaching in ophthalmology trainee courses is effective and appreciated by the medical college students.",2020,"Nineteen students obtained a significant improvement in ranking increased by more than 10 in the last-day-test, whereas they failed to obtain a higher average score for daily performance than other students (t = 0.469, P = 0.654).","['trainee students', 'Before attending ophthalmology trainee courses in Zhongshan Ophthalmic Centre, the medical students from Sun Yat-sen University had finished two years of premedical education after the six-year medical courses including basic medical courses, clinical medical courses, clerkship, and research training in medical college', 'Chinese ophthalmology trainee courses', 'medical college students', '100 medical students attending ophthalmology trainee courses in Zhongshan Ophthalmic Centre']","['integrated modular teaching', 'several sessions delivered in multiple methods, such as ""flipped classroom"" session and team-based learning session']","['satisfaction survey questionnaire', 'total last-day-test score', 'effectiveness and satisfaction scales']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013646', 'cui_str': 'Premedical Education'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",100.0,0.0257951,"Nineteen students obtained a significant improvement in ranking increased by more than 10 in the last-day-test, whereas they failed to obtain a higher average score for daily performance than other students (t = 0.469, P = 0.654).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xin', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ao', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zheqian', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Miaoling', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Chaochao', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yangfan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China. yangyangfan@gzzoc.com.""}, {'ForeName': 'Haotian', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guagzhou, 510060, Guangzhou, People's Republic of China. haot.lin@hotmail.com.""}]",BMC medical education,['10.1186/s12909-020-02073-w']
2568,31444617,"Population pharmacokinetics of fedratinib in patients with myelofibrosis, polycythemia vera, and essential thrombocythemia.","PURPOSE


Fedratinib (SAR302503, TG101348) is an orally administered Janus kinase (JAK) 2-selective inhibitor that is being developed for the treatment of patients with myelofibrosis (MF). The objectives of this analysis were to develop a population pharmacokinetic (PK) model to characterize fedratinib concentration-time profiles in patients with MF, polycythemia vera (PV) and essential thrombocythemia (ET) following oral fedratinib administration; and to investigate the effects of selected covariates on fedratinib PK parameters.
METHODS


Nonlinear mixed effects modeling was employed in developing a population PK model for fedratinib. Intensive or sparse fedratinib concentration data collected in adult subjects with MF, PV or ET from six studies were pooled, and a total of 452 subjects and 3442 plasma concentration observations were included in the final model.
RESULTS


Fedratinib PK in patients with MF/PV/ET was adequately described by a two-compartment structural PK model with first-order absorption incorporating a lag time and first-order elimination. Following oral administration, fedratinib undergoes biphasic disposition and exhibits linear, time-invariant PK at doses of 200 mg and above. Compared to MF/ET patients, PV patients had higher apparent clearance (CL/F) and apparent central volume of distribution. Creatinine clearance was a statistically significant covariate on CL/F, and patients with mild and moderate renal impairment had 10% and 37% increases in fedratinib exposure as compared to patients with normal renal function. No clinically meaningful effect on fedratinib exposure was observed regarding age, body weight, sex, race and liver function.
CONCLUSIONS


These results should serve as the basis for dose adjustment of fedratinib for special populations.",2019,"No clinically meaningful effect on fedratinib exposure was observed regarding age, body weight, sex, race and liver function.
","['patients with MF, polycythemia vera (PV) and essential thrombocythemia (ET) following oral fedratinib administration', 'patients with myelofibrosis, polycythemia vera, and essential thrombocythemia', 'adult subjects with MF, PV or ET from six studies were pooled, and a total of 452 subjects and 3442 plasma concentration observations were included in the final model', 'patients with myelofibrosis (MF']",['Janus kinase (JAK'],"['Creatinine clearance', 'apparent clearance (CL/F) and apparent central volume of distribution', 'moderate renal impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001815', 'cui_str': 'Myelosclerosis with myeloid metaplasia'}, {'cui': 'C0032463', 'cui_str': 'Polycythemia vera'}, {'cui': 'C0040028', 'cui_str': 'Essential thrombocythemia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0597721', 'cui_str': 'JAK Kinases'}]","[{'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]",452.0,0.0207016,"No clinically meaningful effect on fedratinib exposure was observed regarding age, body weight, sex, race and liver function.
","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ogasawara', 'Affiliation': 'Translational Development and Clinical Pharmacology, Celgene Corporation, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Translational Development and Clinical Pharmacology, Celgene Corporation, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Krishna', 'Affiliation': 'Translational Development and Clinical Pharmacology, Celgene Corporation, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Translational Development and Clinical Pharmacology, Celgene Corporation, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Translational Development and Clinical Pharmacology, Celgene Corporation, 556 Morris Ave, Summit, NJ, 07901, USA. yali@celgene.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03929-9']
2569,32429867,Improving mental health literacy in year 9 high school children across Wales: a protocol for a randomised control treatment trial (RCT) of a mental health literacy programme across an entire country.,"BACKGROUND


Adolescence is a crucial period for developing and maintaining good habits for mental health and well-being. This is important for future mental health, as most mental health problems manifest during adolescence. Mental health literacy is the foundation for mental health prevention, stigma reduction, and increased help-seeking efficacy particularly among adolescents. The mental health literacy programme ""The Guide"", which was developed in Canada, has shown success in increasing mental health literacy in North American 16-17 year olds. ""The Guide Cymru"" is an adaptation of The Guide designed for a younger age group (13-14 year olds) and for the Welsh culture and context and is being offered to all state schools in Wales.
METHODS


This two-armed cluster randomised control trial (RCT) will evaluate the effectiveness of The Guide Cymru. All 205 secondary schools in Wales will be invited to take part, involving up to 30,000 year 9 pupils. Schools will be randomised to either the immediate implementation of The Guide Cymru or to a wait-list control. The wait-list control will receive The Guide Cymru around 12 weeks later. Measures of mental health literacy (assessed via the Knowledge and Attitudes to Mental Health scale) and mental health problems (via the PedsQL and Strengths and Difficulties Questionnaire) will be taken at baseline (pre-intervention), 12 weeks later (after the active group has received The Guide Cymru), and 24 weeks later (after the wait-list control has received The Guide Cymru).
DISCUSSION


The trial aims to evaluate if The Guide Cymru increases mental health literacy, including reduced stigma to others and to the self, and increased levels of good mental health behaviours and help-seeking for mental health problems.
TRIAL REGISTRATION


ISRCTN15462041. Registered 03/10/2019.",2020,"Mental health literacy is the foundation for mental health prevention, stigma reduction, and increased help-seeking efficacy particularly among adolescents.","['All 205 secondary schools in Wales will be invited to take part, involving up to 30,000\u2009year 9 pupils', 'year 9 high school children across Wales', 'mental health literacy in North American 16-17\u2009year olds']",['mental health literacy programme'],"['mental health literacy', 'mental health literacy (assessed via the Knowledge and Attitudes to Mental Health scale) and mental health problems (via the PedsQL and Strengths and Difficulties Questionnaire']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}]",,0.0827054,"Mental health literacy is the foundation for mental health prevention, stigma reduction, and increased help-seeking efficacy particularly among adolescents.","[{'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Simkiss', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, UK.'}, {'ForeName': 'Nicola S', 'Initials': 'NS', 'LastName': 'Gray', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, UK.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Malone', 'Affiliation': 'Action for Children, Head Office: 3 The Boulevard, Ascot Road, Watford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kemp', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Snowden', 'Affiliation': 'School of Psychology, Cardiff University, Cardiff, Wales, CF10 3AT, UK. snowden@cardiff.ac.uk.'}]",BMC public health,['10.1186/s12889-020-08736-z']
2570,32429917,Reducing cardiometabolic risk in adults with a low socioeconomic position: protocol of the Supreme Nudge parallel cluster-randomised controlled supermarket trial.,"BACKGROUND


Unhealthy lifestyle behaviours such as unhealthy dietary intake and insufficient physical activity (PA) tend to cluster in adults with a low socioeconomic position (SEP), putting them at high cardiometabolic disease risk. Educational approaches aiming to improve lifestyle behaviours show limited effect in this population. Using environmental and context-specific interventions may create opportunities for sustainable behaviour change. In this study protocol, we describe the design of a real-life supermarket trial combining nudging, pricing and a mobile PA app with the aim to improve lifestyle behaviours and lower cardiometabolic disease risk in adults with a low SEP.
METHODS


The Supreme Nudge trial includes nudging and pricing strategies cluster-randomised on the supermarket level, with: i) control group receiving no intervention; ii) group 1 receiving healthy food nudges (e.g., product placement or promotion); iii) group 2 receiving nudges and pricing strategies (taxing of unhealthy foods and subsidizing healthy foods). In collaboration with a Dutch supermarket chain we will select nine stores located in low SEP neighbourhoods, with the nearest competitor store at > 1 km distance and managed by a committed store manager. Across the clusters, a personalized mobile coaching app targeting walking behaviour will be randomised at the individual level, with: i) control group; ii) a group receiving the mobile PA app. All participants (target n = 1485) should be Dutch-speaking, aged 45-75 years with a low SEP and purchase more than half of their household grocery shopping at the selected supermarkets. Participants will be recruited via advertisements and mail-invitations followed by community-outreach methods. Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up. Secondary outcomes are changes in diastolic blood pressure, blood lipid markers, waist circumference, steps per day, and behavioural factors including healthy food purchasing, food decision style, social cognitive factors related to nudges and to walking behaviours and customer satisfaction after 12 months follow-up. The trial will be reflexively monitored to support current and future implementation.
DISCUSSION


The findings can guide future research and public health policies on reducing lifestyle-related health inequalities, and contribute to a supermarket-based health promotion intervention implementation roadmap.
TRIAL REGISTRATION


Dutch Trial Register ID NL7064, 30th of May, 2018.",2020,"Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up.","['adults with a low socioeconomic position', 'The Supreme Nudge trial includes nudging and pricing strategies cluster-randomised on the supermarket level, with: i', 'adults with a low SEP', 'All participants (target n\xa0=\u20091485) should be Dutch-speaking, aged 45-75\u2009years with a low SEP and purchase more than half of their household grocery shopping at the selected supermarkets', 'Participants will be recruited via advertisements and mail-invitations followed by community-outreach methods', 'adults with a low socioeconomic position (SEP), putting them at high cardiometabolic disease risk']","['control group receiving no intervention; ii) group 1 receiving healthy food nudges (e.g., product placement or promotion); iii) group 2 receiving nudges and pricing strategies (taxing of unhealthy foods and subsidizing healthy foods']","['changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake', 'changes in diastolic blood pressure, blood lipid markers, waist circumference, steps per day, and behavioural factors including healthy food purchasing, food decision style, social cognitive factors related to nudges and to walking behaviours and customer satisfaction', 'cardiometabolic risk', 'lifestyle behaviours']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033118', 'cui_str': 'Pricing'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0282110', 'cui_str': 'Community Outreach'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0033118', 'cui_str': 'Pricing'}, {'cui': 'C0039371', 'cui_str': 'Tax'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009827', 'cui_str': 'Consumer Satisfaction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",,0.122374,"Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up.","[{'ForeName': 'Josine M', 'Initials': 'JM', 'LastName': 'Stuber', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands. j.stuber@amsterdamumc.nl.'}, {'ForeName': 'Joreintje D', 'Initials': 'JD', 'LastName': 'Mackenbach', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Femke E', 'Initials': 'FE', 'LastName': 'de Boer', 'Affiliation': 'Department of Social, Health and Organizational Psychology, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'de Bruijn', 'Affiliation': 'Amsterdam School of Communication Research ASCoR, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Gillebaart', 'Affiliation': 'Department of Social, Health and Organizational Psychology, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Marjolein C', 'Initials': 'MC', 'LastName': 'Harbers', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Jody C', 'Initials': 'JC', 'LastName': 'Hoenink', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Michel C A', 'Initials': 'MCA', 'LastName': 'Klein', 'Affiliation': 'Social AI group, department of Computer Science, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cédric N H', 'Initials': 'CNH', 'LastName': 'Middel', 'Affiliation': 'Athena Institute, Faculty of Science, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Yvonne T', 'Initials': 'YT', 'LastName': 'van der Schouw', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Tjerk Jan', 'Initials': 'TJ', 'LastName': 'Schuitmaker-Warnaar', 'Affiliation': 'Athena Institute, Faculty of Science, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Velema', 'Affiliation': 'Netherlands Nutrition Centre (Voedingscentrum), The Hague, The Netherlands.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Vos', 'Affiliation': 'Amsterdam School of Communication Research ASCoR, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Wilma E', 'Initials': 'WE', 'LastName': 'Waterlander', 'Affiliation': 'Department of Public Health, Amsterdam Public Health research institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Lakerveld', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Joline W J', 'Initials': 'JWJ', 'LastName': 'Beulens', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Amsterdam, Amsterdam, the Netherlands.'}]",Nutrition journal,['10.1186/s12937-020-00562-8']
2571,31390890,Can Nonexperimental Methods Provide Unbiased Estimates of a Breastfeeding Intervention? A Within-Study Comparison of Peer Counseling in Oregon.,"Between July 2005 and July 2007, the Oregon Supplemental Nutrition Program for Women, Infants and Children program conducted the largest randomized field experiment (RFE) ever in the United States to assess the effectiveness of a low-cost peer counseling intervention to promote exclusive breastfeeding. We undertook a within-study comparison of the intervention using unique administrative data between July 2005 and July 2010. We found no difference between experimental and nonexperimental estimates but failed to determine correspondence based on more stringent criteria. We show that tests for nonconsent bias in the benchmark RFE might provide an important signal as to confounding in the nonexperimental estimates.",2019,We found no difference between experimental and nonexperimental estimates but failed to determine correspondence based on more stringent criteria.,[],"['Peer Counseling', 'low-cost peer counseling intervention to promote exclusive breastfeeding']",[],[],"[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3650830', 'cui_str': 'Promotion of exclusive breastfeeding (procedure)'}]",[],,0.0165471,We found no difference between experimental and nonexperimental estimates but failed to determine correspondence based on more stringent criteria.,"[{'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Altindag', 'Affiliation': 'Bentley University, Waltham, MA, USA.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Joyce', 'Affiliation': 'Department of Economics and Finance, Baruch College, New York, NY, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Reeder', 'Affiliation': 'Oregon WIC Program, Portland, OR, USA.'}]",Evaluation review,['10.1177/0193841X19865963']
2572,20371683,Expression of p21 protein predicts clinical outcome in DLBCL patients older than 60 years treated with R-CHOP but not CHOP: a prospective ECOG and Southwest Oncology Group correlative study on E4494.,"PURPOSE


To prospectively investigate the prognostic significance of p21 and p53 expression in diffuse large B-cell lymphoma in the context of the U.S. Intergroup trial comparing conventional cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy to rituximab-CHOP (R-CHOP) induction, with or without maintenance rituximab.
EXPERIMENTAL DESIGN


Immunohistochemical staining of 197 paraffin-embedded biopsy specimens was scored by an independent panel of experts.
RESULTS


The cyclin-dependent kinase inhibitor, p21, was expressed in 55% of cases examined. In a multivariable analysis adjusting for International Prognostic Index score and BCL2 status, p21 expression was a significant, independent, favorable predictive factor for failure-free survival (relative risk, 0.3; P = 0.001) and overall survival (relative risk, 0.3; P = 0.003) for patients treated with R-CHOP. Expression of p21 was not predictive of outcome for CHOP-treated patients. Only p21-positive cases benefited from the addition of rituximab to CHOP. Among p21-positive patients, treatment with R-CHOP was associated with a higher failure-free survival rate at 5 years compared with CHOP (61% versus 24%; P = 0.01). In contrast, no significant differences were detected in failure-free survival according to treatment arm for p21-negative patients. Expression of p53, alone or in combination with p21, did not predict for outcome in univariable or multivariable analyses.
CONCLUSIONS


In this study, p21 protein expression emerged as an important independent predictor of a favorable clinical outcome when rituximab was added to CHOP therapy. These data suggest that rituximab-related effects on lymphoma survival pathways may be functionally linked to p21 activity.",2010,"Expression of p53, alone or in combination with p21, did not predict for outcome in univariable or multivariable analyses.
","['DLBCL patients older than 60 years treated with R-CHOP but not CHOP', 'Immunohistochemical staining of 197 paraffin-embedded biopsy specimens was scored by an independent panel of experts']","['conventional cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy to rituximab-CHOP (R-CHOP) induction, with or without maintenance rituximab', 'rituximab']","['failure-free survival rate', 'failure-free survival', 'overall survival', 'International Prognostic Index score and BCL2 status, p21 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0085185', 'cui_str': 'Paraffin Embedding'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0080058', 'cui_str': 'Proto-Oncogene Proteins p21(ras)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.0492826,"Expression of p53, alone or in combination with p21, did not predict for outcome in univariable or multivariable analyses.
","[{'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Winter', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA. j-winter@northwestern.edu'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Aurora', 'Affiliation': ''}, {'ForeName': 'Daina', 'Initials': 'D', 'LastName': 'Variakojis', 'Affiliation': ''}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Maryla', 'Initials': 'M', 'LastName': 'Krajewska', 'Affiliation': ''}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Habermann', 'Affiliation': ''}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Macon', 'Affiliation': ''}, {'ForeName': 'Mukesh', 'Initials': 'M', 'LastName': 'Chhanabhai', 'Affiliation': ''}, {'ForeName': 'Raymond E', 'Initials': 'RE', 'LastName': 'Felgar', 'Affiliation': ''}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': ''}, {'ForeName': 'L Jeffrey', 'Initials': 'LJ', 'LastName': 'Medeiros', 'Affiliation': ''}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Weick', 'Affiliation': ''}, {'ForeName': 'Edie A', 'Initials': 'EA', 'LastName': 'Weller', 'Affiliation': ''}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Melnick', 'Affiliation': ''}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Reed', 'Affiliation': ''}, {'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Horning', 'Affiliation': ''}, {'ForeName': 'Randy D', 'Initials': 'RD', 'LastName': 'Gascoyne', 'Affiliation': ''}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-09-1219']
2573,32429851,Evaluation of injection-site-related adverse events with galcanezumab: a post hoc analysis of phase 3 studies in participants with migraine.,"BACKGROUND


Injection-site reactions have been reported with biologicals. In this post hoc analysis of Phase 3 studies in participants with migraine, we provide a comprehensive overview and detailed summary of injection-site reaction with galcanezumab.
METHODS


Data were obtained from two randomised clinical studies in participants with episodic migraine (EVOLVE-1 and EVOLVE-2), one randomised study in participants with chronic migraine (REGAIN) and one open-label study (Study CGAJ) in participants with episodic or chronic migraine. The injection-site reactions were measured for two different cohorts: 1) six-month double-blind treatment phase in the EVOLVE-1 and EVOLVE-2 studies and three-month double-blind treatment phase in the REGAIN study, where participants received placebo and galcanezumab (placebo-controlled analysis set); 2) three month double-blind (Month 0 to Month 3; 1:1:placebo:galcanezumab) + 9 months open-label extension phase (Month 3 to Month 12) of REGAIN and twelve month open-label phase of Study CGAJ, where participants received only galcanezumab (galcanezumab exposure analysis set).
RESULTS


A total of 477 participants in the placebo-controlled analysis set (galcanezumab 240 mg, 166/730 [22.7%]; galcanezumab 120 mg, 128/705 [18.2%]; placebo, 183/1451 [12.6%]) reported at least one injection-site reaction. Most of the injection-site reactions were reported as injection-site pain, unspecified injection-site reaction, injection-site erythema, and injection-site pruritus. The incidence of injection-site pain was highest among all reported injection-site reactions and were reported with similar frequency by participants receiving galcanezumab (galcanezumab 120 mg, 10.1%; galcanezumab 240 mg, 11.6%) and placebo (9.5%) and was the most common injection-site reaction reported within 60 min of injection (~ 86% of participants). The frequency of unspecified injection-site reaction, injection-site erythema and injection-site pruritus was significantly (P < 0.001) higher in participant receiving galcanezumab versus placebo. In the galcanezumab exposure analysis set participants received up to 12 doses and the frequency of injection-site reactions reported for both doses combined was 21.8%. The reporting of injection-site reactions did not increase with the number of doses received. No ISR-related serious adverse events were reported in both the placebo-controlled and galcanezumab exposure analysis sets.
CONCLUSIONS


The most common adverse event of galcanezumab is injection-site reactions. However, these events were generally mild-to-moderate in severity, non-serious, resolved spontaneously, and discontinuations due to injection-site reactions were low (1%).",2020,"No ISR-related serious adverse events were reported in both the placebo-controlled and galcanezumab exposure analysis sets.
","['participants with episodic or chronic migraine', 'participants with migraine', 'A total of 477 participants in the', 'participants with episodic migraine (EVOLVE-1 and EVOLVE-2), one randomised study in participants with chronic migraine (REGAIN) and one']","['galcanezumab', 'galcanezumab (galcanezumab', 'placebo and galcanezumab (placebo', 'galcanezumab versus placebo', 'galcanezumab (galcanezumab exposure analysis set', 'open-label study (Study CGAJ', 'placebo-controlled analysis set (galcanezumab', '1:1:placebo:galcanezumab)\u2009+\u20099 months open-label extension phase (Month 3 to Month 12) of REGAIN and twelve month open-label phase of Study CGAJ', 'placebo']","['frequency of unspecified injection-site reaction, injection-site erythema and injection-site pruritus', 'ISR-related serious adverse events', 'reporting of injection-site reactions', 'incidence of injection-site pain']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0852625', 'cui_str': 'Injection site erythema'}, {'cui': 'C0852995', 'cui_str': 'Injection site pruritus'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}]",477.0,0.395407,"No ISR-related serious adverse events were reported in both the placebo-controlled and galcanezumab exposure analysis sets.
","[{'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Stauffer', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA. vstauffer@lilly.com.'}, {'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Bonner', 'Affiliation': 'St. Louis University Hospital, St Louis, USA.'}, {'ForeName': 'ByungKun', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Nowon Eulji Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Bhandari', 'Affiliation': 'Eli Lilly Services India Private Limited, Bangalore, India.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Day', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Camporeale', 'Affiliation': 'Eli Lilly Italia, Sesto Fiorentino, Italy.'}]",BMC neurology,['10.1186/s12883-020-01775-4']
2574,20226809,A randomized feasibility trial of brief telephone counseling to increase fruit and vegetable intakes.,"OBJECTIVE


This study examined the feasibility of eliciting dietary changes in subjects recruited from a diverse primary care setting in Michigan using a written, one-page plan, either alone or with telephone counseling.
METHODS


A total of 96 subjects were enrolled from 9/28/06 to 5/7/07 (49% minorities). Subjects were randomized into three groups. Group 1 received written materials. Group 2 received written materials plus a one-page form that asked them to make a specific daily plan for substituting one less nutritious food with two servings of fruits and vegetables. Group 3 received the written materials, the one-page form and telephone counseling from a dietitian.
RESULTS


Subject retention was 76% for the 12-week study. Subjects in Groups 1, 2 and 3 changed their mean intakes of fruit and vegetables by 0.4, -0.7 and 1.4 servings/day, respectively. Participants in Group 3 lost an average of 0.73 kg, increased their perception of the importance of eating fruits and vegetables, and 63% increased their serum levels of carotenoids by 20% or more.
CONCLUSION


Recruitment through a primary care clinic was effective. Formulation of a written plan combined with telephone counseling appears to be promising for improving fruit and vegetable intakes and warrants more definitive study.",2010,"Subjects in Groups 1, 2 and 3 changed their mean intakes of fruit and vegetables by 0.4, -0.7 and 1.4 servings/day, respectively.","['subjects recruited from a diverse primary care setting in Michigan using a written, one-page plan, either alone or with telephone counseling', 'A total of 96 subjects were enrolled from 9/28/06 to 5/7/07 (49% minorities']","['telephone counseling', 'written materials, the one-page form and telephone counseling from a dietitian', 'written materials', 'written materials plus a one-page form that asked them to make a specific daily plan for substituting one less nutritious food with two servings of fruits and vegetables']","['mean intakes of fruit and vegetables', 'perception of the importance of eating fruits and vegetables', 'fruit and vegetable intakes', 'serum levels of carotenoids']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0453857', 'cui_str': 'Nutritious food (substance)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}]",96.0,0.0118324,"Subjects in Groups 1, 2 and 3 changed their mean intakes of fruit and vegetables by 0.4, -0.7 and 1.4 servings/day, respectively.","[{'ForeName': 'Zora', 'Initials': 'Z', 'LastName': 'Djuric', 'Affiliation': 'University of Michigan, Department of Family Medicine, Ann Arbor, MI 48109, USA. zoralong@umich.edu'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Ellsworth', 'Affiliation': ''}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': ''}, {'ForeName': 'Mack T', 'Initials': 'MT', 'LastName': 'Ruffin', 'Affiliation': ''}]",Preventive medicine,['10.1016/j.ypmed.2010.03.003']
2575,31348415,"Occupationally Tailored, Web-Based, Nutrition and Physical Activity Program for Firefighters: Cluster Randomized Trial and Weight Outcome.","OBJECTIVE


The aim of this study was to determine the efficacy of an occupationally tailored, web-based health and wellness program, The First Twenty® (TF20), for weight change among volunteer firefighters.
METHODS


The impact of TF20 on firefighters' 6-month weight change was tested in a cluster, randomized controlled trial, using a crossover design of firefighters in 10 departments. TF20 has web-based nutrition, physical activity, and behavioral health components.
RESULTS


An adjusted treatment-induced weight loss from 1.7 to 2.8 lb was observed for all participants and 2.3 to 3.1 lb among overweight and obese participants. An average weight gain was observed among firefighters in the control condition and weight loss for those in the treatment condition.
CONCLUSIONS


TF20 supports firefighters' weight loss. Firefighters need wellness interventions to improve nutrition and physical activity given their high prevalence of obesity.",2019,"An average weight gain was observed among firefighters in the control condition and weight loss for those in the treatment condition.
",['firefighters in 10 departments'],['TF20'],"['average weight gain', 'weight loss']","[{'cui': 'C0221459', 'cui_str': 'Fire and Rescue Personnel'}]",[],"[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",10.0,0.0342869,"An average weight gain was observed among firefighters in the control condition and weight loss for those in the treatment condition.
","[{'ForeName': 'R Sue', 'Initials': 'RS', 'LastName': 'Day', 'Affiliation': ""The University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Division of Epidemiology, Human Genetics, & Environmental Sciences, Southwest Center for Occupational and Environmental Health, Michael & Susan Dell Center for Healthy Living, Houston, Texas (Dr Day); National Development and Research Institutes, Inc., Center for Fire, Rescue & EMS Health Research, Institute for Biobehavioral Health Research, Lee's Summit, Missouri (Dr Jahnke, Dr Haddock, Dr Kaipust, Dr Jitnarin, and Dr Poston).""}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Jahnke', 'Affiliation': ''}, {'ForeName': 'C Keith', 'Initials': 'CK', 'LastName': 'Haddock', 'Affiliation': ''}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Kaipust', 'Affiliation': ''}, {'ForeName': 'Nattinee', 'Initials': 'N', 'LastName': 'Jitnarin', 'Affiliation': ''}, {'ForeName': 'Walker S C', 'Initials': 'WSC', 'LastName': 'Poston', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001685']
2576,29518428,The classroom microbiome and asthma morbidity in children attending 3 inner-city schools.,,2018,,['children attending 3 inner-city schools'],[],['asthma morbidity'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],"[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0295334,,"[{'ForeName': 'Peggy S', 'Initials': 'PS', 'LastName': 'Lai', 'Affiliation': 'Massachusetts General Hospital, Boston, Mass; Harvard T.H. Chan School of Public Health, Boston, Mass; Harvard Medical School, Boston, Mass.'}, {'ForeName': 'Raivo', 'Initials': 'R', 'LastName': 'Kolde', 'Affiliation': 'Massachusetts General Hospital, Boston, Mass.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Franzosa', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Mass.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Gaffin', 'Affiliation': ""Harvard Medical School, Boston, Mass; Boston Children's Hospital, Boston, Mass.""}, {'ForeName': 'Sachin N', 'Initials': 'SN', 'LastName': 'Baxi', 'Affiliation': ""Harvard Medical School, Boston, Mass; Boston Children's Hospital, Boston, Mass.""}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sheehan', 'Affiliation': ""Harvard Medical School, Boston, Mass; Boston Children's Hospital, Boston, Mass.""}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Gold', 'Affiliation': ""Harvard T.H. Chan School of Public Health, Boston, Mass; Harvard Medical School, Boston, Mass; Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Gevers', 'Affiliation': 'Broad Institute of MIT and Harvard University, Cambridge, Mass.'}, {'ForeName': 'Ramnik J', 'Initials': 'RJ', 'LastName': 'Xavier', 'Affiliation': 'Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass; Broad Institute of MIT and Harvard University, Cambridge, Mass.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': 'Harvard Medical School, Boston, Mass; Broad Institute of MIT and Harvard University, Cambridge, Mass. Electronic address: wanda.phipatanakul@childrens.harvard.edu.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2018.02.022']
2577,32429969,Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised controlled trial.,"BACKGROUND


Supervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting.
METHODS


This multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1-5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions.
DISCUSSION


The SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH.
TRIAL REGISTRATION


ISRCTN no. 10608766, prospectively registered on 18th March 2019.",2020,"The SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups.","['352 clinically stable adults with PH (groups 1-5) and WHO functional class II-IV', 'people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease', 'A purposive sample of participants (n\xa0', 'people with PH in the community/outpatient setting', 'people with PH']","['supervised exercise rehabilitation intervention', 'Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control', 'Supervised pulmonary hypertension exercise rehabilitation (SPHERe', 'supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan', 'control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity']","['incremental shuttle walk test at 4 months', 'health-related quality of life (HRQoL), time to clinical worsening and health and social care use']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.122139,"The SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups.","[{'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'McGregor', 'Affiliation': 'Department of Cardiopulmonary Rehabilitation, Centre for Exercise & Health, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK. gordon.mcgregor@warwick.ac.uk.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Ennis', 'Affiliation': 'Department of Cardiopulmonary Rehabilitation, Centre for Exercise & Health, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'Centre for Health Economics at Warwick, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Harbinder', 'Initials': 'H', 'LastName': 'Sandhu', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Seers', 'Affiliation': 'Warwick Research in Nursing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Prithwish', 'Initials': 'P', 'LastName': 'Banerjee', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Canaway', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Booth', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Stephanie J C', 'Initials': 'SJC', 'LastName': 'Taylor', 'Affiliation': 'Institute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Robertson', 'Affiliation': 'Patient & Public Involvement Representative, Leicester, UK.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Pincus', 'Affiliation': 'Department of Psychology, Royal Holloway University of London, London, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitzmaurice', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowater', 'Affiliation': 'Department of Cardiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Clift', 'Affiliation': 'Department of Cardiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}]",BMC pulmonary medicine,['10.1186/s12890-020-01182-y']
2578,31426669,Nordic walking and standard exercise therapy in patients with chronic heart failure: A randomised controlled trial comparison.,,2019,,['patients with chronic heart failure'],['Nordic walking and standard exercise therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]",[],,0.084426,,"[{'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Prince', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Evyanne', 'Initials': 'E', 'LastName': 'Wooding', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Mielniczuk', 'Affiliation': 'Division of Cardiology, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Pipe', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Kwan-Leung', 'Initials': 'KL', 'LastName': 'Chan', 'Affiliation': 'Division of Cardiology, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Marja-Leena', 'Initials': 'ML', 'LastName': 'Keast', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Harris', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Tulloch', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mark', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Cotie', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Wells', 'Affiliation': 'Faculty of Medicine, University of Ottawa, Canada.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Reid', 'Affiliation': 'Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Canada.'}]",European journal of preventive cardiology,['10.1177/2047487319871215']
2579,32429977,The effect of oxytocin vaginal gel on vaginal atrophy in postmenopausal women: a randomized controlled trial.,"BACKGROUND


Around 90% of postmenopausal women are suffering from vaginal atrophy. This study aimed to evaluate the effect of oxytocin vaginal gel on vaginal atrophy among postmenopausal women.
METHODS


This was a randomized controlled trial that was conducted on 96 postmenopausal women who suffered from vaginal atrophy. The inclusion criteria were: literate women, age 40-60, at least 1 year passed from their last menstrual period or the level of FSH > 40 IU, monogamous women with the sexual relationship. Women in the intervention group, requested to use one applicator of 400 IU oxytocin gel per night and women in the placebo group used placebo each night. The subjective symptoms of vaginal atrophy, vaginal PH, maturation index were measured before and after the intervention.
RESULTS


The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7 ± 7.18 vs. 3.69 ± 2.76, p = 0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention. The improvement of the maturation index was more dominant in the oxytocin group (increased from 7.76 ± 4.68 to 52.48 ± 7.54) in comparison to the placebo group (increased from 8.58 ± 4.35 to 13.25 ± 5.06). The PH of the vagina decreased significantly in the oxytocin group in comparison to the placebo group (p = 0.0001). After 8 weeks, 88.6 and 7.1% of women in the oxytocin and placebo groups did not show the severe symptoms of vaginal atrophy (p = 0.001).
CONCLUSION


The results of this study showed that eight- week intervention with oxytocin vaginal gel (400 IU) could significantly improve the vaginal maturation index, subjective symptoms of vaginal atrophy and reduce the PH of the vagina. Using this medication in women who have a contraindication for hormone therapy is recommended.
TRIAL REGISTRATION


IRCT20160602028220N2.",2020,"The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7 ± 7.18 vs. 3.69 ± 2.76, p = 0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention.","['96 postmenopausal women who suffered from vaginal atrophy', 'women who have a contraindication for hormone therapy is recommended', 'The inclusion criteria were: literate women, age 40-60, at least 1 year passed from their last menstrual period or the level of FSH\u2009>\u200940\u2009IU, monogamous women with the sexual relationship', 'postmenopausal women', 'postmenopausal women are suffering from vaginal atrophy']","['placebo', 'oxytocin vaginal gel', 'oxytocin', 'oxytocin gel per night and women in the placebo']","['maturation index', 'vaginal maturation index, subjective symptoms of vaginal atrophy and reduce the PH of the vagina', 'vaginal atrophy', 'severe symptoms of vaginal atrophy', 'number of superficial cells', 'number of parabasal cells', 'subjective symptoms of vaginal atrophy, vaginal PH, maturation index', 'PH of the vagina']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0241616', 'cui_str': 'Atrophy of vagina'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0425932', 'cui_str': 'Date of last menstrual period'}, {'cui': 'C0558125', 'cui_str': 'Monogamous'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0241616', 'cui_str': 'Atrophy of vagina'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}]",96.0,0.337173,"The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7 ± 7.18 vs. 3.69 ± 2.76, p = 0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention.","[{'ForeName': 'Ilnaz', 'Initials': 'I', 'LastName': 'Zohrabi', 'Affiliation': 'Menopause Andropause Research Center, Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Abedi', 'Affiliation': 'Menopause Andropause Research Center, Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran. parvinabdei@ymail.com.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'Menopause Andropause Research Center, Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Maraghi', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Shakiba Maram', 'Affiliation': 'Pharmaceutics Department, Nanotechnology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Houshmand', 'Affiliation': 'Department of Pharmacology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}]",BMC women's health,['10.1186/s12905-020-00935-5']
2580,32429983,Development of an intervention to facilitate implementation and uptake of diabetic retinopathy screening.,"BACKGROUND


'Implementation interventions' refer to methods used to enhance the adoption and implementation of clinical interventions such as diabetic retinopathy screening (DRS). DRS is effective, yet uptake is often suboptimal. Despite most routine management taking place in primary care and the central role of health care professionals (HCP) in referring to DRS, few interventions have been developed for primary care. We aimed to develop a multifaceted intervention targeting both professionals and patients to improve DRS uptake as an example of a systematic development process combining theory, stakeholder involvement, and evidence.
METHODS


First, we identified target behaviours through an audit in primary care of screening attendance. Second, we interviewed patients (n = 47) and HCP (n = 30), to identify determinants of uptake using the Theoretical Domains Framework, mapping these to behaviour change techniques (BCTs) to develop intervention content. Thirdly, we conducted semi-structured consensus groups with stakeholders, specifically users of the intervention, i.e. patients (n = 15) and HCPs (n = 16), regarding the feasibility, acceptability, and local relevance of selected BCTs and potential delivery modes. We consulted representatives from the national DRS programme to check intervention 'fit' with existing processes. We applied the APEASE criteria (affordability, practicability, effectiveness, acceptability, side effects, and equity) to select the final intervention components, drawing on findings from the previous steps, and a rapid evidence review of operationalised BCT effectiveness.
RESULTS


We identified potentially modifiable target behaviours at the patient (consent, attendance) and professional (registration) level. Patient barriers to consent/attendance included confusion between screening and routine eye checks, and fear of a negative result. Enablers included a recommendation from friends/family or professionals and recognising screening importance. Professional barriers to registration included the time to register patients and a lack of readily available information on uptake in their local area/practice. Most operationalised BCTs were acceptable to patients and HCPs while the response to feasibility varied. After considering APEASE, the core intervention, incorporating a range of BCTs, involved audit/feedback, electronic prompts targeting professionals, HCP-endorsed reminders (face-to-face, by phone and letter), and an information leaflet for patients.
CONCLUSIONS


Using the example of an intervention to improve DRS uptake, this study illustrates an approach to integrate theory with user involvement. This process highlighted tensions between theory-informed and stakeholder suggestions, and the need to apply the Theoretical Domains Framework (TDF)/BCT structure flexibly. The final intervention draws on the trusted professional-patient relationship, leveraging existing services to enhance implementation of the DRS programme. Intervention feasibility in primary care will be evaluated in a randomised cluster pilot trial.",2020,"After considering APEASE, the core intervention, incorporating a range of BCTs, involved audit/feedback, electronic prompts targeting professionals, HCP-endorsed reminders (face-to-face, by phone and letter), and an information leaflet for patients.
",[],['HCPs'],[],[],[],[],47.0,0.0559924,"After considering APEASE, the core intervention, incorporating a range of BCTs, involved audit/feedback, electronic prompts targeting professionals, HCP-endorsed reminders (face-to-face, by phone and letter), and an information leaflet for patients.
","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Riordan', 'Affiliation': 'School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland. fiona.riordan@ucc.ie.'}, {'ForeName': 'Emmy', 'Initials': 'E', 'LastName': 'Racine', 'Affiliation': 'School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}, {'ForeName': 'Eunice T', 'Initials': 'ET', 'LastName': 'Phillip', 'Affiliation': 'School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Bradley', 'Affiliation': 'Department of General Practice, University College Cork, Cork, Ireland.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Lorencatto', 'Affiliation': 'Centre for Behaviour Change, University College London, London, England.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Murphy', 'Affiliation': 'Department of General Practice, Royal College of Surgeons of Ireland, Dublin, Ireland.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Murphy', 'Affiliation': 'Department of Economics, Cork University Business School, University College Cork, Cork, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Browne', 'Affiliation': 'School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'Department of General Practice, Royal College of Surgeons of Ireland, Dublin, Ireland.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': 'School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}, {'ForeName': 'Sheena M', 'Initials': 'SM', 'LastName': 'McHugh', 'Affiliation': 'School of Public Health, University College Cork, Western Gateway Building, Western Rd, Cork, Ireland.'}]",Implementation science : IS,['10.1186/s13012-020-00982-4']
2581,32430047,"Confidence, attitudes, beliefs and determinants of implementation behaviours among physiotherapists towards clinical management of low back pain before and after implementation of the BetterBack model of care.","BACKGROUND


Implementing clinical guidelines is challenging. To facilitate uptake, we developed a model of care (BetterBack Model of Care) and an implementation strategy to support management of low back pain in primary care. The aim of this study was to evaluate physiotherapists´ confidence, attitudes and beliefs in managing patients with low back pain before and after a multifaceted implementation of the BetterBack Model of Care. A further aim was to evaluate determinants of implementation behaviours among physiotherapists.
METHODS


This clinical trial was an experimental before and after study within a hybrid type 2 effectiveness-implementation trial. The primary outcome was Practitioner Self-Confidence Scale (PCS), secondary outcomes were the Pain Attitude and Beliefs Scale for Physiotherapists (PABS-PT) and Determinants of Implementation Behaviour Questionnaire (DIBQ). Data was analysed using repeated measures ANOVA and pairwise comparisons.
RESULTS


One hundred sixteen physiotherapists answered a questionnaire before, directly after, as well as 3 and 12 months after implementation of the Model of Care. PCS improved over time with a large effect size post implementation (η p 2  = 0.197, p < 0.001). Changes in PABS-PT were only significant after 12 months with higher biopsychosocial orientation, (η p 2  = 0.071, p < 0.01) and lower biomedical orientation, (η p 2  = 0.136, p < 0.001). Directly after the workshop, after 3 and 12 months, physiotherapists had high ratings on all DIBQ domains, (scores > 50) implying that all were potential facilitators of the implementation. However, after 3 months, all domains had significantly decreased except for organisation, social influence and patient expectation domains. However, after 12 months, organisation and social influence domains had significantly decreased while domains such as knowledge, skills and beliefs about capabilities returned to initial levels.
CONCLUSIONS


Physiotherapists´ confidence and biopsychosocial orientation increased after implementation and may have the potential to improve management of low back pain in primary care. The implementation behaviour showed mostly facilitating patterns but changed over time, pinpointing a need to repeatedly monitor these changes. This can inform the need for changes of implementation efforts in different phases and support sustainability strategies.
TRAIL REGISTRATION


ClinicalTrials.gov NCT03147300 3 May 2017, prospectivly registered.",2020,"Directly after the workshop, after 3 and 12 months, physiotherapists had high ratings on all DIBQ domains, (scores > 50) implying that all were potential facilitators of the implementation.","['low back pain in primary care', 'One hundred sixteen physiotherapists', 'managing patients with low back pain before and after a multifaceted implementation of the BetterBack Model of Care', 'Physiotherapists']",['PCS'],"['Confidence, attitudes, beliefs and determinants of implementation behaviours', 'organisation and social influence domains', 'knowledge, skills and beliefs about capabilities returned to initial levels', 'confidence and biopsychosocial orientation', 'Practitioner Self-Confidence Scale (PCS), secondary outcomes were the Pain Attitude and Beliefs Scale for Physiotherapists (PABS-PT) and Determinants of Implementation Behaviour Questionnaire (DIBQ', 'organisation, social influence and patient expectation domains']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",,0.0878517,"Directly after the workshop, after 3 and 12 months, physiotherapists had high ratings on all DIBQ domains, (scores > 50) implying that all were potential facilitators of the implementation.","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Schröder', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, 581 83, Linköping, Sweden. karin.schroder@liu.se.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Öberg', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Enthoven', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kongsted', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230, Odense M, Denmark.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbott', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, 581 83, Linköping, Sweden.'}]",BMC health services research,['10.1186/s12913-020-05197-3']
2582,32430890,Living Arrangements and Supplemental Income Programs for Older Adults in Mexico.,"Living arrangements often reflect important quality-of-life indicators for elderly adults. In particular, increased income can prompt changes in household living arrangements for elderly adults. Using a differences-in-differences approach, we examine whether a supplemental income program in Mexico for adults aged 70 and older influenced household size and composition. We compare outcomes at baseline and at six-month follow-up for elderly adults in the treatment group with those in the control group that did not participate in the program. We find that household size increased by 3% in the treatment group relative to the control group. We also find a statistically significant increase in the number of girls aged 6-11 in the household, likely the granddaughters or great-granddaughters of program recipients. Increases in household size were greatest for adults aged 70-79, couples, households receiving two or more supplemental incomes, and households in the top income tercile. Household size did not increase for households of adults aged 80 and older, singles, households with only one supplemental income recipient, and households not in the top income tercile. These results suggest that when older adults have more income, they use part of this income to house their grandchildren.",2020,"Household size did not increase for households of adults aged 80 and older, singles, households with only one supplemental income recipient, and households not in the top income tercile.","['adults aged 70-79, couples, households receiving two or more supplemental incomes, and households in the top income tercile', 'Older Adults in Mexico', 'elderly adults in the treatment group with those in the control group that did not participate in the program', 'adults aged 70 and older influenced household size and composition', 'elderly adults']",['supplemental income program'],['household size'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]","[{'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0386983,"Household size did not increase for households of adults aged 80 and older, singles, households with only one supplemental income recipient, and households not in the top income tercile.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Aguila', 'Affiliation': 'Sol Price School of Public Policy, University of Southern California, 650 Childs Way, Los Angeles, CA, 90089, USA. eaguilav@usc.edu.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Sol Price School of Public Policy, University of Southern California, 650 Childs Way, Los Angeles, CA, 90089, USA.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Vega', 'Affiliation': 'Kaiser Permanente, 393 East Walnut St., Pasadena, CA, 91108, USA.'}]",Demography,['10.1007/s13524-020-00879-3']
2583,32430108,Early Point-of-Care Ultrasound Assessment for Medical Patients Reduces Time to Appropriate Treatment: A Pilot Randomized Controlled Trial.,"Numerous studies emphasize the diagnostic importance of point-of-care ultrasound (POCUS), but the level of evidence remains low as most data are gathered from observational studies. We conducted a pilot, randomized controlled trial to evaluate the effect of POCUS exam on medical patient's management and clinical outcomes. Patients presenting with chest pain or dyspnea were enrolled and randomly allocated to an early POCUS scan group and a control group. POCUS assessment, within 24 h of internal ward admission, was conducted only for the intervention group. The primary outcome was time to correct diagnosis. Secondary outcomes included time to appropriate treatment, POCUS-related rate of primary diagnosis alteration and new clinically relevant findings and time to hospital discharge. Sixty patients were enrolled. Thirty patients were randomly allocated to each study arm. The POCUS exam revealed clinically relevant findings among 79% of patients and led to alteration of the primary diagnosis among 28% of patients. Time to appropriate treatment was significantly shorter among patients in the POCUS group compared with the control group (median time of 5 h [95% confidence interval: 0.5-9] vs. 24 h [95% CI: 19-29] p = 0.014). The time needed to achieve correct diagnosis by the primary team was shorter in the POCUS group compared with the control group, yet it did not reach statistical significance (median time of 24 h [95% CI: 18-30] vs. 48 h [95% CI: 20-76], p = 0.12). These results indicate that POCUS assessment conducted early among patients with dyspnea or chest pain improves diagnostic accuracy and shortens significantly the time to appropriate treatment.",2020,"The time needed to achieve correct diagnosis by the primary team was shorter in the POCUS group compared with the control group, yet it did not reach statistical significance (median time of 24 h [95% CI: 18-30] vs. 48 h [95% CI: 20-76], p = 0.12).","['Medical Patients Reduces Time to Appropriate Treatment', 'Sixty patients were enrolled', 'Thirty patients', 'Patients presenting with chest pain or dyspnea']","['early POCUS scan group and a control group', 'POCUS exam']","['time to appropriate treatment, POCUS-related rate of primary diagnosis alteration and new clinically relevant findings and time to hospital discharge', 'diagnostic accuracy', 'time needed to achieve correct diagnosis', 'time to correct diagnosis']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",60.0,0.175229,"The time needed to achieve correct diagnosis by the primary team was shorter in the POCUS group compared with the control group, yet it did not reach statistical significance (median time of 24 h [95% CI: 18-30] vs. 48 h [95% CI: 20-76], p = 0.12).","[{'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Ben-Baruch Golan', 'Affiliation': 'Internal Medicine Division, Soroka University Medical Center, Beer-Sheva, Israel. Electronic address: golany860@gmail.com.'}, {'ForeName': ""Re'em"", 'Initials': 'R', 'LastName': 'Sadeh', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Clinical Research Center, Soroka University Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Mizrakli', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Clinical Research Center, Soroka University Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Shafat', 'Affiliation': 'Internal Medicine Division, Soroka University Medical Center, Beer-Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Iftach', 'Initials': 'I', 'LastName': 'Sagy', 'Affiliation': 'Internal Medicine Division, Soroka University Medical Center, Beer-Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Tzachi', 'Initials': 'T', 'LastName': 'Slutsky', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Emergency Department, Soroka University Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Sergio L', 'Initials': 'SL', 'LastName': 'Kobal', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Cardiology Department, Soroka University Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Novack', 'Affiliation': 'Internal Medicine Division, Soroka University Medical Center, Beer-Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Clinical Research Center, Soroka University Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Fuchs', 'Affiliation': 'Internal Medicine Division, Soroka University Medical Center, Beer-Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}]",Ultrasound in medicine & biology,['10.1016/j.ultrasmedbio.2020.03.023']
2584,32430896,Correction to: Endoscopic Argon Plasma Coagulation Vs. Multidisciplinary Evaluation in the Management of Weight Regain after Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.,In the original article the captions for Figs. 1-3 are incorrect.,2020,1-3 are incorrect.,['after Gastric Bypass Surgery'],"['SHAM', 'Endoscopic Argon Plasma Coagulation Vs']",['Weight Regain'],"[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1879736', 'cui_str': 'Argon plasma coagulation'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.102734,1-3 are incorrect.,"[{'ForeName': 'Luiz Gustavo', 'Initials': 'LG', 'LastName': 'de Quadros', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil. Gustavo_quadros@hotmail.com.'}, {'ForeName': 'Manoel Galvão', 'Initials': 'MG', 'LastName': 'Neto', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'João Caetano', 'Initials': 'JC', 'LastName': 'Marchesini', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Teixeira', 'Affiliation': 'Orlando Health Hospital, Orlando, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Grecco', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Roberto Luiz Kaiser', 'Initials': 'RLK', 'LastName': 'Junior', 'Affiliation': 'Beneficência Portuguesa Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Zundel', 'Affiliation': 'Jackson North Medical Center, University at Buffalo, Miami, USA.'}, {'ForeName': 'Idiberto José Zotarelli', 'Initials': 'IJZ', 'LastName': 'Filho', 'Affiliation': 'Kaiser Day Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Thiago Ferreira', 'Initials': 'TF', 'LastName': 'de Souza', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Admar Concon', 'Initials': 'AC', 'LastName': 'Filho', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Lyz Bezerra', 'Initials': 'LB', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Josemberg Marins', 'Initials': 'JM', 'LastName': 'Campos', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04478-4']
2585,32430167,Gamification in rehabilitation of metacarpal fracture using cost-effective end-user device: A randomized controlled trial.,"STUDY DESIGN


This is a two-group randomized controlled trial.
INTRODUCTION


Finger stiffness after treatment for metacarpal fractures often occurs due to poor compliance to the conventional rehabilitation programs. Gamification has shown success in improving adherence to and effectiveness of various therapies.
PURPOSE OF THE STUDY


The purpose of this study was to evaluate whether gamification, using cost-effective devices was comparable with conventional physiotherapy in improving hand functions and adherence to rehabilitation in metacarpal fractures.
METHODS


A 2-group randomized controlled trial involving 19 patients was conducted. Participants were randomized to a control (conventional physiotherapy, n = 10) or interventional group (gamification, n = 9). The grips strength and composite finger range of motion were measured at the baseline and each follow-up together with Patient-Rated Wrist and Hand Evaluation scores and compliance.
RESULTS


There were no significant differences on improvements of grip strength (means difference 24.38 vs 20.44, P = .289) and composite finger range of motion (means difference 50.50 vs 51.11, P = .886). However, the gamification group showed better results in Patient-Rated Wrist and Hand Evaluation (mean 0.44 vs 8.45, P = .038) and compliance (P < .05). No adverse events were reported.
DISCUSSION


Our results suggest that gamification using a cost-effective device demonstrated similar effectiveness as conventional physiotherapy in post-metacarpal fracture rehabilitation.
CONCLUSIONS


Gamification using a mobile device is an inexpensive and safe alternative to conventional physiotherapy for hand rehabilitation after metacarpal fractures. It effectively serves as a guide for future development of cost-effective technology-enhanced therapy.",2020,"There were no significant differences on improvements of grip strength (means difference 24.38 vs 20.44, P = .289) and composite finger range of motion (means difference 50.50 vs 51.11, P = .886).",['19 patients was conducted'],"['conventional physiotherapy', 'control (conventional physiotherapy, n\xa0=\xa010) or interventional group (gamification, n\xa0=\xa09']","['Patient-Rated Wrist and Hand Evaluation', 'composite finger range of motion', 'grip strength', 'adverse events', 'grips strength and composite finger range of motion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0575830', 'cui_str': 'Finger joint - range of movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",19.0,0.0811644,"There were no significant differences on improvements of grip strength (means difference 24.38 vs 20.44, P = .289) and composite finger range of motion (means difference 50.50 vs 51.11, P = .886).","[{'ForeName': 'Jun Wei', 'Initials': 'JW', 'LastName': 'Then', 'Affiliation': 'Faculty of Medicine, Department of Orthopaedic Surgery, National Orthopaedic Centre of Excellence for Research and Learning (NOCERAL), University Malaya, Kuala Lumpur, Malaysia. Electronic address: drjwthen_1004@yahoo.com.my.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Shivdas', 'Affiliation': 'Upper Limb & Reconstructive Microsurgery Unit, Faculty of Medicine, Department of Orthopaedic Surgery, National Orthopaedic Centre of Excellence for Research and Learning (NOCERAL), University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Tunku Sara', 'Initials': 'TS', 'LastName': 'Tunku Ahmad Yahaya', 'Affiliation': 'Upper Limb & Reconstructive Microsurgery Unit, Faculty of Medicine, Department of Orthopaedic Surgery, National Orthopaedic Centre of Excellence for Research and Learning (NOCERAL), University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nor Izzati', 'Initials': 'NI', 'LastName': 'Ab Razak', 'Affiliation': 'Upper Limb & Reconstructive Microsurgery Unit, Faculty of Medicine, Department of Orthopaedic Surgery, National Orthopaedic Centre of Excellence for Research and Learning (NOCERAL), University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Pee Terh', 'Initials': 'PT', 'LastName': 'Choo', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital Sultanah Bahiyah, Alor Setar, Kedah, Malaysia.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2020.03.029']
2586,32430078,"Supervised exercise protocol for lower limbs in subjects with chronic venous disease: an evaluator-blinded, randomized clinical trial.","BACKGROUND


Chronic venous insufficiency (CVI) causes pathophysiological changes in the lower-limb muscles, particularly the calf muscles, and limits ankle range of motion (ROM). These changes reduce functional activities and decrease quality of life (QOL). Although several studies have shown the benefits of exercise (strengthening the calf muscles to improve calf-muscle pumping and QOL) in patients with CVI, few studies are randomized controlled trials. This has led to a weak indication of exercise for the treatment of patients with CVI. The aim of this study is to analyze the effects of a supervised exercise program to improve calf-muscle endurance as well as QOL in patients with CVI.
METHODS/DESIGN


This is an evaluator-blind, randomized clinical trial with an 8-week duration and a follow-up evaluation at week 16. A pilot study with subjects with a CVI diagnosis will be performed to calculate sample size. The participants will be randomly allocated (1:1) into a treatment or a control group (usual care/no intervention). The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening and cardiovascular exercises. The participants from both groups will participate in a health education lecture. Primary outcomes are changes in calf-muscle endurance and QOL score. Secondary outcomes are changes in exercise capacity, ankle ROM, electrical muscle activity and cardiac output. The first statistical comparison will be performed after 8 weeks' intervention.
DISCUSSION


Patients with CVI may have an impaired calf-muscle pump and decreased exercise capacity. A randomized controlled trial evaluating a supervised exercise program should provide much needed information on the management of CVI to promote health and independence.
TRIAL REGISTRATION


This study was registered on the Brazilian Clinical Trials Database (REBEC) (RBR-57xtk7). The results will be disseminated at scientific events, presentations, and publications in peer-reviewed journals.",2020,"The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening and cardiovascular exercises.","['subjects with a CVI diagnosis', 'subjects with chronic venous disease', 'patients with CVI']","['Supervised exercise protocol', 'supervised exercise program', 'bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening and cardiovascular exercises', 'control group (usual care/no intervention']","['changes in calf-muscle endurance and QOL score', 'functional activities and decrease quality of life (QOL', 'changes in exercise capacity, ankle ROM, electrical muscle activity and cardiac output', 'calf-muscle endurance']","[{'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",,0.117019,"The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening and cardiovascular exercises.","[{'ForeName': 'Esther Fernandes Tinoco', 'Initials': 'EFT', 'LastName': 'Volpe', 'Affiliation': 'PneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil.'}, {'ForeName': 'Vanessa R', 'Initials': 'VR', 'LastName': 'Resqueti', 'Affiliation': 'PneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil.'}, {'ForeName': 'Ana Aline Marcelino', 'Initials': 'AAM', 'LastName': 'da Silva', 'Affiliation': 'PneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil.'}, {'ForeName': 'Lucien Peroni', 'Initials': 'LP', 'LastName': 'Gualdi', 'Affiliation': 'PneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil.'}, {'ForeName': 'Guilherme A F', 'Initials': 'GAF', 'LastName': 'Fregonezi', 'Affiliation': 'PneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil. fregonezi.guilherme@gmail.com.'}]",Trials,['10.1186/s13063-020-04314-1']
2587,32431023,Fatigue and activity after stroke. Secondary results from the Life After Stroke study.,"OBJECTIVES


The aim of this study was to describe how the prevalence of fatigue changed from the subacute phase to the chronic phase after stroke, and to investigate how activity was associated with fatigue among participants included in the randomized controlled multicentre-study Life After STroke (LAST).
METHODS


The present study represents secondary analysis based on data from the LAST study. One-hundred-and-forty-five patients with mild and moderate stroke (mean (SD) age: 71.5 (10.5) years, 57.2% males) recruited from St. Olav's University Hospital were included. Fatigue was assessed by the Fatigue Severity Scale (FSS-7) at inclusion, 3 months after stroke, and at follow-up 18 months later. activPAL was used to measure activity at follow-up.
RESULTS


A total of 46 (31.7%) participants reported fatigue at inclusion and 43 (29.7%) at follow-up (p = .736). In the univariable regression analysis, sedentary behaviour, walking and sedentary bouts were significantly associated with fatigue (p ≤ .015), whereas only time spent walking was significantly associated with fatigue in the multivariable regression analysis (p = .017).
CONCLUSIONS


The present study showed that fatigue is a common symptom after stroke and that the prevalence of fatigue remained unchanged from the subacute to the chronic phase. The study also showed that increased time spent walking was strongly related to lower fatigue, while no such associations were found between the other activity categories and fatigue.",2020,"In the univariable regression analysis, sedentary behaviour, walking and sedentary bouts were significantly associated with fatigue (p ≤ .015), whereas only time spent walking was significantly associated with fatigue in the multivariable regression analysis (p = .017).
","[""One-hundred-and-forty-five patients with mild and moderate stroke (mean (SD) age: 71.5 (10.5) years, 57.2% males) recruited from St. Olav's University Hospital were included""]",['activPAL'],"['Life', 'sedentary behaviour, walking and sedentary bouts', 'Fatigue and activity', 'fatigue', 'activity categories and fatigue', 'Fatigue', 'time spent walking', 'Fatigue Severity Scale (FSS-7']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0265224', 'cui_str': 'Freeman-Sheldon syndrome'}]",145.0,0.0425954,"In the univariable regression analysis, sedentary behaviour, walking and sedentary bouts were significantly associated with fatigue (p ≤ .015), whereas only time spent walking was significantly associated with fatigue in the multivariable regression analysis (p = .017).
","[{'ForeName': 'Ragnhild Sunde', 'Initials': 'RS', 'LastName': 'Braaten', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Torunn', 'Initials': 'T', 'LastName': 'Askim', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Gunnes', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Indredavik', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1851']
2588,32430987,Negative pressure drainage assisted irrigation for maxillofacial space infection.,"OBJECTIVE


In this study, the clinical effect of negative pressure drainage assisted irrigation (NPDI) technique was evaluated in treating maxillofacial space infection (MSI) by comparing with traditional technique.
METHOD


A prospective study was conducted in 58 patients with MSI. The patients were randomly divided into two groups based on different treatment techniques. 30 patients receiving NPDI were included in NPDI group, and 28 patients receiving traditional technique were included in traditional group. Case data (gender, age, etiology, concurrent illness, diabetes, involved spaces, preoperative white cell count, airway control method) and clinical effect (postoperative hospital stay, total cost of admission) for the 2 groups were analyzed.
RESULTS


Patients in both groups were cured clinically. There were no significant differences in gender, age, etiology, concurrent illness, diabetes, involved spaces, preoperative white cell count, airway control method in NPDI group and traditional group (P> 0.05). The postoperative hospital stay and the total cost of admission in the NPDI group was significantly lower than the traditional group (P <0.001).
CONCLUSION


NPDI used in the treatment of MSI can shorten the postoperative hospital stay, reduce the total cost of admission, and show favorably clinical effect. It is a clinically recommended method for MSI.",2020,"The postoperative hospital stay and the total cost of admission in the NPDI group was significantly lower than the traditional group (P <0.001).
","['30 patients receiving NPDI were included in NPDI group, and 28 patients receiving traditional technique were included in traditional group', '58 patients with MSI']","['negative pressure drainage assisted irrigation (NPDI) technique', 'Negative pressure drainage assisted irrigation']","['clinical effect (postoperative hospital stay, total cost of admission', 'gender, age, etiology, concurrent illness, diabetes, involved spaces, preoperative white cell count, airway control method', 'postoperative hospital stay and the total cost of admission', 'total cost of admission', 'postoperative hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",58.0,0.0131721,"The postoperative hospital stay and the total cost of admission in the NPDI group was significantly lower than the traditional group (P <0.001).
","[{'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Stomatology, the Affiliated Hospital of Qingdao University, Qingdao, 266003, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Stomatology, Qingdao University, Qingdao, Shandong, 266071, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yue', 'Affiliation': 'School of Stomatology, Qingdao University, Qingdao, Shandong, 266071, China.'}, {'ForeName': 'Yao-Xiang', 'Initials': 'YX', 'LastName': 'Xu', 'Affiliation': 'School of Stomatology, Qingdao University, Qingdao, Shandong, 266071, China.'}, {'ForeName': 'Zhen-Zhen', 'Initials': 'ZZ', 'LastName': 'Fu', 'Affiliation': 'Department of Stomatology, the Affiliated Hospital of Qingdao University, Qingdao, 266003, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Ding', 'Affiliation': 'Department of Stomatology, the Affiliated Hospital of Qingdao University, Qingdao, 266003, China.'}, {'ForeName': 'Wen-Lin', 'Initials': 'WL', 'LastName': 'Xiao', 'Affiliation': 'Department of Stomatology, the Affiliated Hospital of Qingdao University, Qingdao, 266003, China.'}]",Oral diseases,['10.1111/odi.13421']
2589,32431299,Modification effects of T2DM-susceptible SNPs on the reduction of blood glucose in response to lifestyle interventions.,"In recent years, it has been demonstrated that some susceptible gene loci of type 2 diabetes mellitus (T2DM) are not only associated with the susceptibility risk of T2DM, but also the modifying effects of lifestyle interventions. To further explore the modifying effects of the single nucleotide polymorphism (SNP) on the onset of T2DM and the reduction of blood glucose in response to lifestyle interventions among the high-risk population, we performed a lifestyle intervention study in two Deqing rural communities during the period from June to December in 2017. The intensive lifestyle interventions were conducted among the study subjects of the intervention group while those in the control group only received conventional and general health education. All participants were genotyped by the MassARRY system. This study showed that for SNP rs9502570, fasting blood glucose showed a significantly greater reduction for individuals with CC + CT genotype than those with TT genotype ( P =0.031). In the intervention group, the glycated hemoglobin A1C (HbA1C) decreased by 0.03% for those with CC+CT genotype, while HbA1C increased by 0.27% for those with TT genotype ( P =0.012). The difference in the reduction of fasting blood glucose and HbA1c between the intervention and control groups was also statistically significant between individuals with TT and those with CC+CT genotype. For SNP rs10811661, the reduction of fasting blood glucose was significantly higher in people with TT genotype than those with CC + CT genotype (0.44 mmol/L vs 0.12 mmol/L,  P =0.021). The difference in reduction of fasting blood glucose between the intervention group and control group was also statistically significant between TT and CC+CT genotype ( P <0.001). In summary, the SNP genotypes of both rs9502570 and rs10811661 could modify the effects of lifestyle interventions on reducing fasting blood glucose and HbA1C among the high risk rural population for T2DM. The present study has provided supporting evidence for future development of individualized intervention measures for high-risk population of T2DM.",2020,The difference in the reduction of fasting blood glucose and HbA1c between the intervention and control groups was also statistically significant between individuals with TT and those with CC+CT genotype.,['two Deqing rural communities during the period from June to December in 2017'],"['T2DM-susceptible SNPs', 'single nucleotide polymorphism (SNP', 'control group only received conventional and general health education']","['fasting blood glucose', 'reduction of fasting blood glucose', 'blood glucose', 'SNP rs9502570, fasting blood glucose', 'fasting blood glucose and HbA1c', 'HbA1C', 'glycated hemoglobin A1C (HbA1C', 'fasting blood glucose and HbA1C']","[{'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",2.0,0.0109742,The difference in the reduction of fasting blood glucose and HbA1c between the intervention and control groups was also statistically significant between individuals with TT and those with CC+CT genotype.,"[{'ForeName': 'Yu Zhuo', 'Initials': 'YZ', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety of Ministry of Education, Key Laboratory of Health Technology Assessment, National Health Commission, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yi Ming', 'Initials': 'YM', 'LastName': 'Zhang', 'Affiliation': 'Deqing County Center for Disease Prevention and Control, Deqing County 313200, China.'}, {'ForeName': 'Xiao Lian', 'Initials': 'XL', 'LastName': 'Dong', 'Affiliation': 'Deqing County Center for Disease Prevention and Control, Deqing County 313200, China.'}, {'ForeName': 'Xue Cai', 'Initials': 'XC', 'LastName': 'Wang', 'Affiliation': 'Deqing County Center for Disease Prevention and Control, Deqing County 313200, China.'}, {'ForeName': 'Jian Fu', 'Initials': 'JF', 'LastName': 'Zhu', 'Affiliation': 'Deqing County Center for Disease Prevention and Control, Deqing County 313200, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety of Ministry of Education, Key Laboratory of Health Technology Assessment, National Health Commission, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety of Ministry of Education, Key Laboratory of Health Technology Assessment, National Health Commission, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Faculty of Medicine, University of Ottawa, Ottawa K1N6N5, Canada.'}, {'ForeName': 'Qing Wu', 'Initials': 'QW', 'LastName': 'Jiang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety of Ministry of Education, Key Laboratory of Health Technology Assessment, National Health Commission, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Chao Wei', 'Initials': 'CW', 'LastName': 'Fu', 'Affiliation': 'Department of Epidemiology, School of Public Health, Key Laboratory of Public Health Safety of Ministry of Education, Key Laboratory of Health Technology Assessment, National Health Commission, Fudan University, Shanghai 200032, China.'}]",Yi chuan = Hereditas,['10.16288/j.yczz.19-304']
2590,32431191,Topical tacrolimus with different frequency for exfoliative cheilitis: a pilot study.,"Background:  Tacrolimus is a new type immunosuppressant. The aim of this study was to evaluate the effectiveness of topical tacrolimus 0.1% ointment at 2 different frequencies in treating patients with exfoliative cheilitis. Methods:  A total of 40 patients with exfoliative cheilitis were randomly divided into QD group receiving topical tacrolimus 0.1% ointment once a day or QOD group receiving topical tacrolimus 0.1% ointment once-two-day. Patients were also applied wet dressing of saline twice a day. The effectiveness of treatment was defined as the percentage of improvement in signs or symptoms. Results:  37 patients completed the 2-week treatment. And, a full set was analyzed. The effectiveness of topical tacrolimus 0.1% ointment for relief in objective sign and subjective symptom was 50% and 67.5%% in QD group, respectively. For QOD group, the effectiveness of sign and symptom relief was 50% and 73.5%. There was no significant difference of effectiveness between application topical tacrolimus once a day and once two days. Conclusion:  Our data suggested that application of topical tacrolimus 0.1% ointment once a day and once two days had similar clinical effectiveness for sign and symptom relief in patients with exfoliative cheilitis.",2020,"The effectiveness of topical tacrolimus 0.1% ointment for relief in objective sign and subjective symptom was 50% and 67.5%% in QD group, respectively.","['37 patients completed the 2-week treatment', 'exfoliative cheilitis', '40 patients with exfoliative cheilitis', 'patients with exfoliative cheilitis']","['Tacrolimus', 'topical tacrolimus 0.1% ointment once a day or QOD group receiving topical tacrolimus 0.1% ointment once-two-day', 'topical tacrolimus', 'Topical tacrolimus']","['objective sign and subjective symptom', 'effectiveness of sign and symptom relief']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0341058', 'cui_str': 'Exfoliative cheilitis'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0939241', 'cui_str': 'Tacrolimus-containing product in cutaneous dose form'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0558287', 'cui_str': 'Alternate days'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",40.0,0.0834622,"The effectiveness of topical tacrolimus 0.1% ointment for relief in objective sign and subjective symptom was 50% and 67.5%% in QD group, respectively.","[{'ForeName': 'Qian-Qian', 'Initials': 'QQ', 'LastName': 'Zhang', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Liu', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Wei-Wen', 'Initials': 'WW', 'LastName': 'Jiang', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1771258']
2591,32431208,Effects of Morning Versus Evening Home-Based Exercise on Subjective and Objective Sleep Parameters in Older Adults: A Randomized Controlled Trial.,"OBJECTIVE


This study aimed to determine whether the timing of exercise influenced the effects of home-based low-intensity stepping exercises on the sleep parameters of older adults.
METHOD


For 8 weeks, 60 healthy older adults participated in a randomized controlled trial, performing low-intensity aerobic exercise (70-80 bpm) for about 30 minutes every day at home, either in the morning (from waking until 12:00) or evening (18:00 to bedtime).
RESULTS


In the evening exercise group, both subjectively and objectively measured sleep latency significantly improved throughout the intervention. Further, postintervention subjective sleep satisfaction was significantly higher in the evening group (6.2 ± 1.3 points) than in the morning group (5.2 ± 1.4 points;  P  = .006). Additionally, sleep variables related to evening exercise had larger effect sizes (Cohen  d ) than those performed in the morning.
CONCLUSION


Engaging in low-intensity stepping exercises during the evening is potentially a useful nonpharmacological approach to improving sleep quality among older adults.",2020,"Further, postintervention subjective sleep satisfaction was significantly higher in the evening group (6.2 ± 1.3 points) than in the morning group (5.2 ± 1.4 points;  P  = .006).","['60 healthy older adults', 'Older Adults', 'older adults']","['low-intensity aerobic exercise', 'Morning Versus Evening Home-Based Exercise', 'home-based low-intensity stepping exercises']","['Subjective and Objective Sleep Parameters', 'postintervention subjective sleep satisfaction', 'sleep quality', 'sleep latency']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}]",60.0,0.0826357,"Further, postintervention subjective sleep satisfaction was significantly higher in the evening group (6.2 ± 1.3 points) than in the morning group (5.2 ± 1.4 points;  P  = .006).","[{'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Seol', 'Affiliation': 'Doctoral Program in Physical Education, Health and Sport Sciences, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Fujii', 'Affiliation': 'Doctoral Program in Physical Education, Health and Sport Sciences, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Taiki', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': ""Master's Program in Physical Education, Health and Sport Sciences, University of Tsukuba, Ibaraki, Japan.""}, {'ForeName': 'Naruki', 'Initials': 'N', 'LastName': 'Kitano', 'Affiliation': 'Physical Fitness Research Institute, Meiji Yasuda Life Foundation of Health and Welfare, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tsunoda', 'Affiliation': 'Faculty of Social Welfare, Yamaguchi Prefectural University, Yamaguchi, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Okura', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Ibaraki, Japan.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988720924709']
2592,32431211,Accurately Reflecting Uncertainty When Using Patient-Level Simulation Models to Extrapolate Clinical Trial Data.,"Introduction.  Patient-level simulation models facilitate extrapolation of clinical trial data while allowing for heterogeneity, prior history, and nonlinearity. However, combining different types of uncertainty around within-trial and extrapolated results remains challenging.  Methods.  We tested 4 methods to combine parameter uncertainty (around the regression coefficients used to predict future events) with sampling uncertainty (uncertainty around mean risk factors within the finite sample whose outcomes are being predicted and the effect of treatment on these risk factors). We compared these 4 methods using a simulation study based on an economic evaluation extrapolating the AFORRD randomized controlled trial using the UK Prospective Diabetes Study Outcomes Model version 2. This established type 2 diabetes model predicts patient-level health outcomes and costs.  Results.  The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value). Allowing for sampling uncertainty as well as parameter uncertainty widened confidence intervals by 6.3-fold and gave 96.3% coverage. Methods adjusting for baseline risk factors that combine sampling and parameter uncertainty overcame the bias that can result from between-group baseline imbalance and gave confidence intervals around 50% wider than those just considering parameter uncertainty, with 99.8% coverage.  Conclusions.  Analyses extrapolating data for individual trial participants should include both sampling uncertainty and parameter uncertainty and should adjust for any imbalance in baseline covariates.",2020,"The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value).",[],[],[],[],[],[],,0.0800414,"The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value).","[{'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Dakin', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'Department of Health Services Research & Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20916442']
2593,32431238,Extraversion as a Moderator of the Efficacy of Self-Esteem Maintenance Strategies.,"Four experiments explored how extraversion's connection with self-esteem may depend on specific self-enhancement strategies. Participants' self-esteem threatening feedback indicating that they had performed poorly on a vocabulary or emotional intelligence test. In Experiment 1, participants ( N  = 80) were randomly assigned to either a control condition (no self-enhancement) or a downward social comparison condition. The procedures for Experiments 2 ( N  = 470) and 3 ( N  = 514) were similar, adding a self-serving attribution condition (Experiments 2 and 3) and Basking-in-Reflected-Glory (BIRG) condition (Experiment 3). Across the experiments, extraversion was more related to self-esteem under downward social comparison versus other conditions. BIRGing produced higher self-esteem in Experiment 3 across extraversion levels. Experiment 4 ( N  = 355) focused on downward social comparison versus control, and provided evidence that an increased perception of being similar to the comparison targets may partially explain extraversion's self-esteem link. Theoretical implications concerning both extraversion and self-enhancement are discussed.",2020,BIRGing produced higher self-esteem in Experiment 3 across extraversion levels.,['participants ( N  = 80'],['control condition (no self-enhancement) or a downward social comparison condition'],['self-esteem'],[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0205104', 'cui_str': 'Down'}]","[{'cui': 'C0036597', 'cui_str': 'Self-esteem'}]",514.0,0.011076,BIRGing produced higher self-esteem in Experiment 3 across extraversion levels.,"[{'ForeName': 'Thomas I', 'Initials': 'TI', 'LastName': 'Vaughan-Johnston', 'Affiliation': ""Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'MacGregor', 'Affiliation': 'The Ohio State University, Columbus, USA.'}, {'ForeName': 'Leandre R', 'Initials': 'LR', 'LastName': 'Fabrigar', 'Affiliation': ""Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Lyndsay E', 'Initials': 'LE', 'LastName': 'Evraire', 'Affiliation': 'University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Wasylkiw', 'Affiliation': 'Mount Allison University, Sackville, New Brunswick, Canada.'}]",Personality & social psychology bulletin,['10.1177/0146167220921713']
2594,32431251,Can the PROPER intervention reduce psychotropic drug prescription in nursing home residents with dementia? Results of a cluster-randomized controlled trial.,"OBJECTIVES


To evaluate the effect of the PROPER intervention in nursing home residents with dementia on the prevalence of psychotropic drug use and neuropsychiatric symptoms.
DESIGN


A cluster-randomized controlled design with two parallel groups (intervention versus usual care) and assessments at 0, 6, 12, and 18 months.
SETTING


Thirty-one dementia special care units within 13 long-term care organizations in the Netherlands.
PARTICIPANTS


Three hundred eighty nursing home residents with dementia.
INTERVENTION


The PROPER intervention consisted of a structured and repeated multidisciplinary medication review, supported by education and continuous evaluation.
MEASUREMENTS


Prescriptions of antipsychotics, antidepressants, anxiolytics, and hypnotics, and occurrence of neuropsychiatric symptoms.
RESULTS


The prescription of any type of psychotropic drugs increased in the intervention group, and decreased in the control group, with an estimated difference of 3.9 percentage points per 6 months (p = 0.01). Effects for the individual drug groups were minor (differences of 1.6 percentage points and below per 6 months) and not statistically significant. The occurrence of neuropsychiatric symptoms remained stable in both the intervention and control groups during the follow-up of 18 months.
CONCLUSIONS


The PROPER intervention failed to demonstrate effectiveness in reducing the prevalence of psychotropic drugs. It may be interesting to enrich the intervention with components that address personal attitudes and communication between nursing home professionals, not only with respect to the prescription of psychotropic drugs, but also to neuropsychiatric symptoms.The study has been registered in The Netherlands Trial Register (NTR3569).",2020,"The occurrence of neuropsychiatric symptoms remained stable in both the intervention and control groups during the follow-up of 18 months.
","['Thirty-one dementia special care units within 13 long-term care organizations in the Netherlands', 'nursing home residents with dementia on the prevalence of psychotropic drug use and neuropsychiatric symptoms', 'nursing home residents with dementia', 'Three hundred eighty nursing home residents with dementia']",['PROPER intervention'],"['prescription of any type of psychotropic drugs', 'Prescriptions of antipsychotics, antidepressants, anxiolytics, and hypnotics, and occurrence of neuropsychiatric symptoms', 'occurrence of neuropsychiatric symptoms']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0558600', 'cui_str': 'Special care unit'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}]",,0.0487555,"The occurrence of neuropsychiatric symptoms remained stable in both the intervention and control groups during the follow-up of 18 months.
","[{'ForeName': 'C H W', 'Initials': 'CHW', 'LastName': 'Smeets', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud University Medical Center Alzheimer Center, Nijmegen, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Smalbrugge', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, Amsterdam UMC, location VUmc / Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'R T C M', 'Initials': 'RTCM', 'LastName': 'Koopmans', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud University Medical Center Alzheimer Center, Nijmegen, the Netherlands.'}, {'ForeName': 'M H J M G', 'Initials': 'MHJMG', 'LastName': 'Nelissen-Vrancken', 'Affiliation': 'Dutch Institute for Rational Use of Medicine, Utrecht, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'van der Spek', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud University Medical Center Alzheimer Center, Nijmegen, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Teerenstra', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Health Evidence, section Biostatistics, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud University Medical Center Alzheimer Center, Nijmegen, the Netherlands.'}, {'ForeName': 'S U', 'Initials': 'SU', 'LastName': 'Zuidema', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}]",International psychogeriatrics,['10.1017/S1041610220000629']
2595,32431047,Subjective-objective sleep discrepancy in patients with insomnia during and after cognitive behavioural therapy: An actigraphy study.,"Although patients with insomnia often show a discrepancy between self-reported and objective sleep parameters, the role of and change in this phenomenon during treatment remain unclear. The present study aimed to assess the effect of cognitive behavioural therapy for insomnia on subjective and objective sleep discrepancy of total sleep time, sleep-onset latency and wake after sleep onset. The total sleep time discrepancy was also assessed across the entire therapy. The second aim was to examine the treatment outcome of two insomnia groups differing in sleep perception. Thirty-six adults with insomnia (mean age = 46.7 years, SD = 13.9; 22 females) were enrolled in the final analyses. Patients underwent a 6-week group cognitive behavioural therapy for insomnia programme. Sleep diary and actigraphy measurements were obtained during the therapy. Patients who underestimated total sleep time (n = 16; underestimating group) were compared with patients who accurately perceived or overestimated total sleep time (n = 20; accurate/overestimating group). After cognitive behavioural therapy for insomnia, a significant decrease of total sleep time and sleep-onset latency discrepancy was observed without a change in wake after sleep onset discrepancy in the total sample. Only the underestimating group reported decreased sleep-onset latency discrepancy after the treatment, whereas total sleep time discrepancy significantly changed in both groups. The underestimating group showed a significant decrease of total sleep time discrepancy from Week 1 to Week 2 when the sleep restriction was implemented, whereas the accurate/overestimating group showed the first significant change at Week 4. In conclusion, both groups differing in sleep perception responded similarly to cognitive behavioural therapy for insomnia, although different In conclusion, both groups differing in sleep perception responded similarly to cognitive behavioural therapy for insomnia, although different therapeutic components could play important roles in each group. components could play important roles in each group.",2020,"The underestimating group showed a significant decrease of total sleep time discrepancy from Week 1 to Week 2 when the sleep restriction was implemented, whereas the accurate/overestimating group showed the first significant change at Week 4.","['Thirty-six adults with insomnia (mean age\xa0=\xa046.7\u2005years, SD\xa0=\xa013.9; 22 females', 'patients with insomnia during and after cognitive behavioural therapy']","['cognitive behavioural therapy', '6-week group cognitive behavioural therapy']","['subjective and objective sleep discrepancy of total sleep time, sleep-onset latency and wake after sleep onset', 'total sleep time', 'Subjective-objective sleep discrepancy', 'Sleep diary and actigraphy measurements', 'total sleep time and sleep-onset latency discrepancy', 'total sleep time discrepancy', 'sleep-onset latency discrepancy']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",36.0,0.0152607,"The underestimating group showed a significant decrease of total sleep time discrepancy from Week 1 to Week 2 when the sleep restriction was implemented, whereas the accurate/overestimating group showed the first significant change at Week 4.","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Janků', 'Affiliation': 'National Institute of Mental Health, Klecany, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Šmotek', 'Affiliation': 'National Institute of Mental Health, Klecany, Czech Republic.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fárková', 'Affiliation': 'National Institute of Mental Health, Klecany, Czech Republic.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Kopřivová', 'Affiliation': 'National Institute of Mental Health, Klecany, Czech Republic.'}]",Journal of sleep research,['10.1111/jsr.13064']
2596,32128848,The effects of acute and sustained cannabidiol dosing for seven days on the haemodynamics in healthy men: A randomised controlled trial.,"BACKGROUND


In vivo studies show that cannabidiol (CBD) acutely reduces blood pressure (BP) in men. The aim of this study was to assess the effects of repeated CBD dosing on haemodynamics.
METHODS


Twenty-six healthy males were given CBD (600 mg) or placebo orally for seven days in a randomised, placebo-controlled, double-blind, parallel study (n = 13/group). Cardiovascular parameters were assessed at rest and in response to isometric exercise after acute and repeated dosing using Finometer®, Vicorder® and Duplex ultrasound.
RESULTS


Compared to placebo, CBD significantly reduced resting mean arterial pressure (P = .04, two-way ANOVA, mean difference (MD) -2 mmHg, 95% CI -3.6 to -0.3) after acute dosing, but not after repeated dosing. In response to stress, volunteers who had taken CBD had lower systolic BP after acute (P = .001, two-way ANOVA, MD -6 mmHg, 95% CI -10 to -1) and repeated (P = .02, two-way ANOVA, MD -5.7 mmHg, 95% CI -10 to -1) dosing. Seven days of CBD increased internal carotid artery diameter (MD +0.55 mm, P = .01). Within the CBD group, repeated dosing reduced arterial stiffness by day 7 (pulse wave velocity; MD -0.44 m/s, P = .05) and improved endothelial function (flow mediation dilatation, MD +3.5%, P = .02, n = 6 per group), compared to day 1.
CONCLUSION


CBD reduces BP at rest after a single dose but the effect is lost after seven days of treatment (tolerance); however, BP reduction during stress persists. The reduction in arterial stiffness and improvements in endothelial function after repeated CBD dosing are findings that warrant further investigation in populations with vascular diseases.",2020,"Seven days of CBD increased internal carotid artery diameter (MD +0.55 mm, P = .01).","['Twenty-six healthy males', 'healthy men', 'men']","['placebo', 'CBD', 'placebo, CBD', 'cannabidiol (CBD']","['Cardiovascular parameters', 'BP reduction', 'systolic BP', 'blood pressure (BP', 'arterial stiffness', 'resting mean arterial pressure', 'internal carotid artery diameter', 'endothelial function']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",26.0,0.459438,"Seven days of CBD increased internal carotid artery diameter (MD +0.55 mm, P = .01).","[{'ForeName': 'Salahaden R', 'Initials': 'SR', 'LastName': 'Sultan', 'Affiliation': 'Vascular Medicine, Division of Medical Sciences & Graduate Entry Medicine, School of Medicine, University of Nottingham, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Saoirse E', 'Initials': 'SE', 'LastName': ""O'Sullivan"", 'Affiliation': 'Vascular Medicine, Division of Medical Sciences & Graduate Entry Medicine, School of Medicine, University of Nottingham, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'England', 'Affiliation': 'Vascular Medicine, Division of Medical Sciences & Graduate Entry Medicine, School of Medicine, University of Nottingham, Royal Derby Hospital, Derby, UK.'}]",British journal of clinical pharmacology,['10.1111/bcp.14225']
2597,32431275,Efficacy of a Spatial Repellent for Control of Malaria in Indonesia: A Cluster-Randomized Controlled Trial.,"A cluster-randomized, double-blinded, placebo-controlled trial was conducted to estimate the protective efficacy (PE) of a spatial repellent (SR) against malaria infection in Sumba, Indonesia. Following radical cure in 1,341 children aged ≥ 6 months to ≤ 5 years in 24 clusters, households were given transfluthrin or placebo passive emanators (devices designed to release vaporized chemical). Monthly blood screening and biweekly human-landing mosquito catches were performed during a 10-month baseline (June 2015-March 2016) and a 24-month intervention period (April 2016-April 2018). Screening detected 164 first-time infections and an accumulative total of 459 infections in 667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households. The 24-cluster protective effect of 27.7% and 31.3%, for time to first-event and overall (total new) infections, respectively, was not statistically significant. Purportedly, this was due in part to zero to low incidence in some clusters, undermining the ability to detect a protective effect. Subgroup analysis of 19 clusters where at least one infection occurred during baseline showed 33.3% ( P -value = 0.083) and 40.9% ( P -value = 0.0236, statistically significant at the one-sided 5% significance level) protective effect to first infection and overall infections, respectively. Among 12 moderate- to high-risk clusters, a statistically significant decrease in infection by intervention was detected (60% PE). Primary entomological analysis of impact was inconclusive. Although this study suggests SRs prevent malaria, additional evidence is required to demonstrate the product class provides an operationally feasible and effective means of reducing malaria transmission.",2020,"Screening detected 164 first-time infections and an accumulative total of 459 infections in 667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households.","['Control of Malaria in Indonesia', '1,341 children aged ≥ 6 months to ≤ 5 years in 24 clusters, households were given', '667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households']","['transfluthrin or placebo passive emanators (devices designed to release vaporized chemical', 'Monthly blood screening and biweekly human-landing mosquito catches', 'placebo']","['infection by intervention', 'protective efficacy (PE', '24-cluster protective effect', 'time to first-event and overall (total new) infections']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C4517851', 'cui_str': '667'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C4517848', 'cui_str': '665'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3178479', 'cui_str': 'transfluthrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086137', 'cui_str': 'Device Design'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0026584', 'cui_str': 'Family Culicidae'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205314', 'cui_str': 'New'}]",1341.0,0.277179,"Screening detected 164 first-time infections and an accumulative total of 459 infections in 667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households.","[{'ForeName': 'Din', 'Initials': 'D', 'LastName': 'Syafruddin', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia.'}, {'ForeName': 'Puji B S', 'Initials': 'PBS', 'LastName': 'Asih', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia.'}, {'ForeName': 'Ismail Ekoprayitno', 'Initials': 'IE', 'LastName': 'Rozi', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia.'}, {'ForeName': 'Dendi Hadi', 'Initials': 'DH', 'LastName': 'Permana', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia.'}, {'ForeName': 'Anggi Puspa', 'Initials': 'AP', 'LastName': 'Nur Hidayati', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia.'}, {'ForeName': 'Lepa', 'Initials': 'L', 'LastName': 'Syahrani', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia.'}, {'ForeName': 'Siti', 'Initials': 'S', 'LastName': 'Zubaidah', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Sidik', 'Affiliation': 'Department of Epidemiology, Faculty of Public Health, Universitas Hasanuddin, Makassar, Indonesia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bangs', 'Affiliation': 'Public Health and Malaria Control, PT Freeport Indonesia, International SOS, Kuala Kencana, Papua, Indonesia.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Bøgh', 'Affiliation': 'The Sumba Foundation, Public Health and Malaria Control, Bali, Indonesia.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Applied Mathematics, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Evercita C', 'Initials': 'EC', 'LastName': 'Eugenio', 'Affiliation': 'Department of Applied Mathematics, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Hendrickson', 'Affiliation': 'Center for Computer Research, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Burton', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Baird', 'Affiliation': 'Nuffield Department of Medicine, Centre for Tropical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Collins', 'Affiliation': 'Center for Computer Research, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Grieco', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Neil F', 'Initials': 'NF', 'LastName': 'Lobo', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Achee', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0554']
2598,31525490,CHAMP: A cluster randomized-control trial to prevent obesity in child care centers.,"Foundational elements of lifelong health are formed during the preschool years. Child care attendance has nearly doubled in the past 5 years making child care centers an ideal setting to establish healthy habits that prevent pediatric obesity. Despite the promising evidence of efficacy of child care-based obesity prevention interventions, limited attention has been directed to criteria needed for implementation at scale. There is potential to improve children's dietary and physical activity behaviors in diverse communities through theory-based, culturally appropriate, manualized interventions, delivered by child care staff. CHAMP (Creating Healthy Habits Among Maryland Preschoolers) is a 3-arm cluster randomized controlled childhood obesity prevention trial, aiming to improve motor skills, physical activity and willingness to try new foods among 864 preschoolers (age 3-5 years) enrolled in 54 child care centers in 10 Maryland counties. CHAMP is informed by social-cognitive and bioecological theories and based on an evidence-based program, The Food Friends®. The two intervention arms include: 1) child care-center based lessons (18-week gross motor and 12-week nutrition) administered by trained child care staff, and 2) a web-based intervention for caregivers in addition to center-based lessons. Evaluations are conducted among children, caregivers, and child care staff at fall enrollment, midline, and spring, following intervention completion. Analyses include linear mixed-models, accounting for clustering and repeated measures, incorporating center-arms as moderators. CHAMP will provide evidence-based information to inform wellness guidelines and policies that can be disseminated broadly, to ensure that child care centers provide opportunities for children to develop healthy eating, and physical activity habits. Trial Registration: NCT03111264; https://clinicaltrials.gov/ct2/show/NCT03111264.",2019,Child care attendance has nearly doubled in the past 5 years making child care centers an ideal setting to establish healthy habits that prevent pediatric obesity.,"['864 preschoolers (age 3-5\u202fyears) enrolled in 54 child care centers in 10 Maryland counties', 'child care centers', 'Creating Healthy Habits', 'Maryland Preschoolers']","['1) child care-center based lessons (18-week gross motor and 12-week nutrition) administered by trained child care staff, and 2) a web-based intervention for caregivers in addition to center-based lessons', 'CHAMP', 'CHAMP ']","[""children's dietary and physical activity behaviors"", 'Child care attendance']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}]",864.0,0.0374942,Child care attendance has nearly doubled in the past 5 years making child care centers an ideal setting to establish healthy habits that prevent pediatric obesity.,"[{'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America.'}, {'ForeName': 'Angela C B', 'Initials': 'ACB', 'LastName': 'Trude', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America.'}, {'ForeName': 'Romulus J', 'Initials': 'RJ', 'LastName': 'Castelo', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Zemanick', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Haber-Sage', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Arbaiza', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Black', 'Affiliation': 'University of Maryland Baltimore School of Medicine, Department of Pediatrics, United States of America; RTI International, Department of Pediatrics, United States of America. Electronic address: mblack@som.umaryland.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105849']
2599,32129558,Validation of the Australian Treatment Outcomes Profile for use in clients with cannabis dependence.,"INTRODUCTION AND AIMS


The Australian Treatment Outcomes Profile (ATOP) was developed as a clinical tool for monitoring the substance use, health and wellbeing of clients in alcohol and other drug treatment. This is the first psychometric validation of the ATOP in a cannabis-dependent treatment population.
DESIGN AND METHODS


A total of 128 individuals with cannabis dependence enrolled in an outpatient randomised controlled trial were administered the ATOP and gold-standard health and wellbeing questionnaires once by clinicians and once by researchers at baseline. Concurrent validity was assessed by testing ATOP Psychological Health, Physical Health and Quality of Life questions against concurrently administered gold-standard questionnaires: the Short Form 36 Health Survey (SF-36), the 21-item Depression, Anxiety and Stress Scale (DASS-21) and the Sheehan Disability Scale (SDS). Interrater reliability was tested by comparing clinician-administered ATOP items at the medical screening interview to the same ATOP items administered by researchers at baseline.
RESULTS


ATOP Psychological Health showed moderate to strong correlations with SF-36 Mental Components, SF-36 Mental Health and DASS-21 scores (r = 0.40-0.52) and ATOP Physical Health with SF-36 Physical Components and SF-36 General Health scores (r = 0.36-0.67). The ATOP Quality of Life scale showed moderate agreement with the SDS and six-dimensional health state short form scales (r = 0.38-0.40). ATOP substance use, employment, education and child care items showed good to excellent interrater reliability (Krippendorff's α = 0.62-0.81), and tobacco use, Psychological Health, Physical Health and Quality of Life showed fair to moderate interrater reliability (Krippendorff's α = 0.42-0.53).
DISCUSSION AND CONCLUSIONS


The ATOP appears to be valid and reliable when tested in a population with cannabis-dependence, justifying its widespread use in clinical settings.",2020,"RESULTS


ATOP Psychological Health showed moderate to strong correlations with SF-36 Mental Components, SF-36 Mental Health and DASS-21 scores (r = 0.40-0.52) and ATOP Physical Health with SF-36 Physical Components and SF-36 General Health scores (r = 0.36-0.67).","['128 individuals with cannabis dependence enrolled', 'clients with cannabis dependence']",['ATOP and gold-standard health and wellbeing questionnaires once by clinicians and once by researchers at baseline'],"['tobacco use, Psychological Health, Physical Health and Quality of Life', 'ATOP Physical Health with SF-36 Physical Components and SF-36 General Health scores', 'SF-36 Mental Components, SF-36 Mental Health and DASS-21 scores', 'testing ATOP Psychological Health, Physical Health and Quality of Life questions against concurrently administered gold-standard questionnaires: the Short Form 36 Health Survey (SF-36), the 21-item Depression, Anxiety and Stress Scale (DASS-21) and the Sheehan Disability Scale (SDS', 'substance use, health and wellbeing of clients in alcohol', 'ATOP Quality of Life scale', 'Interrater reliability']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0006870', 'cui_str': 'Cannabis Dependence'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]","[{'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",128.0,0.0326362,"RESULTS


ATOP Psychological Health showed moderate to strong correlations with SF-36 Mental Components, SF-36 Mental Health and DASS-21 scores (r = 0.40-0.52) and ATOP Physical Health with SF-36 Physical Components and SF-36 General Health scores (r = 0.36-0.67).","[{'ForeName': 'Llewellyn', 'Initials': 'L', 'LastName': 'Mills', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': 'School of Medicine, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Montebello', 'Affiliation': 'Discipline of Addiction Medicine, Faculty Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Dunlop', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network, Sydney, Australia.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Deacon', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Copeland', 'Affiliation': 'Mind and Neuroscience Thompson Institute, University of the Sunshine Coast, Sunshine Coast, Australia.'}, {'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Jefferies', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network, Sydney, Australia.'}, {'ForeName': 'Consuelo', 'Initials': 'C', 'LastName': 'Rivas', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Mammen', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}]",Drug and alcohol review,['10.1111/dar.13050']
2600,31525488,Improving communication toward ICU families to facilitate understanding and reduce stress. Protocol for a multicenter randomized and controlled Italian study.,"OBJECTIVE


Families of ICU patients have a pressing need for information: they find themselves suddenly in a complex technical environment often because of a life-threatening illness of a loved one. Some evidence suggests that specific communication tools (like websites or brochures) could improve the experience of ICU families.
DESIGN


Randomized, multicenter, stepped wedge trial for large-scale assessment of the effectiveness of a multitasking intervention to improve communication with families of critically ill patients.
MAIN OUTCOME


correct understanding of the prognosis.
SECONDARY OUTCOMES


correct understanding of medical treatments, prevalence of anxiety, depression and post-traumatic stress symptoms in the first ICU week. Prevalence of PTSD 6 months from ICU discharge. Empathy and burnout among ICU staff. Prevalence of refusals for tissues/organ donation, and medical claims.
SUBJECTS


2100 ICU relatives of critically ill patients.
INTERVENTIONS


The intervention employs specific tools especially designed to raise the correctness of information and to improve the quality of communication: a website presenting the ICU world and justifying the relatives' emotions, with a webpage specifically dedicated to each participating ICU; a standard brochure; eight posters for the families' waiting room and a signboard for the ICU door.
MEASUREMENTS AND MAIN RESULTS


The study plans to assess these materials in up to 300 Italian ICUs that will participate, according to a five waves program, each one with randomized starting order. This way the effect of the intervention will be evaluated simultaneously.
CONCLUSION


This is an educational study, aiming to spread good medical practices, while also verifying their real effectiveness in a large number of ICUs.
TRIAL REGISTRATION NUMBER


NCT03438175.",2019,"The intervention employs specific tools especially designed to raise the correctness of information and to improve the quality of communication: a website presenting the ICU world and justifying the relatives' emotions, with a webpage specifically dedicated to each participating ICU; a standard brochure; eight posters for the families' waiting room and a signboard for the ICU door.
","['Families of ICU patients', 'critically ill patients', '2100 ICU relatives of critically ill patients']",['multitasking intervention'],"['medical treatments, prevalence of anxiety, depression and post-traumatic stress symptoms']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",[],"[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}]",2100.0,0.0391207,"The intervention employs specific tools especially designed to raise the correctness of information and to improve the quality of communication: a website presenting the ICU world and justifying the relatives' emotions, with a webpage specifically dedicated to each participating ICU; a standard brochure; eight posters for the families' waiting room and a signboard for the ICU door.
","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Mistraletti', 'Affiliation': 'Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti, Università degli Studi di Milano, Italy; SC Anestesia e Rianimazione, ASST Santi Paolo e Carlo, Ospedale San Paolo - Polo Universitario, Milano, Italy. Electronic address: giovanni.mistraletti@unimi.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mezzetti', 'Affiliation': 'AUSL Toscana Centro, SOS 118 Emergenza Territoriale, Empoli, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Anania', 'Affiliation': 'SC Anestesia e Rianimazione, ASST Santi Paolo e Carlo, Ospedale San Paolo - Polo Universitario, Milano, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ionescu Maddalena', 'Affiliation': ""Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Roma, Italy; Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Del Negro', 'Affiliation': 'SC Anestesia e Rianimazione, ASST Santi Paolo e Carlo, Ospedale San Paolo - Polo Universitario, Milano, Italy.'}, {'ForeName': 'Gian Domenico', 'Initials': 'GD', 'LastName': 'Giusti', 'Affiliation': 'AOU S. Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Gili', 'Affiliation': 'Dipartimento di Medicina Sperimentale, Università degli Studi di Perugia, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Iacobone', 'Affiliation': 'SAR, Dipartimento Emergenza-Urgenza, AV3 Ospedale di Macerata, ASUR Marche, Italy.'}, {'ForeName': 'Silvia Maria', 'Initials': 'SM', 'LastName': 'Pulitanò', 'Affiliation': ""Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Roma, Italy; Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': ""Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Roma, Italy; Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.""}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Bocci', 'Affiliation': ""Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Roma, Italy; Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.""}]",Contemporary clinical trials,['10.1016/j.cct.2019.105847']
2601,32431534,Parasternal Intercostal Block Complementation Contributes to Postoperative Pain Relief in Modified Radical Mastectomy Employing Pectoral Nerve Block I and Serratus-Intercostal Block: A Randomized Trial.,"Purpose


Pectoral nerve block I (PECS I) and serratus-intercostal plane block (SIPB) can anesthetize the majority mammary region, while parasternal intercostal block (PSI) targets the internal area during breast resection surgery. The aim of this study was to determine whether including PSI with PECS I and SIPB is more effective compared to PECS I and SIPB alone.
Patients and Methods


Sixty-two adult females undergoing unilateral modified radical mastectomy (MRM) were randomly assigned to receive either PECS I and SIPB (PS group, n=31) or a combination of PECS I, SIPB, and PSI (PSP group, n=31). The outcomes were measured with a numerical rating scale (NRS) score, and in terms of opioid consumption and anesthesia-related complications within 48 h after surgery.
Results


Although there were no differences in the NRS scores between the two groups during the inactive periods, the combination of three nerve blocks significantly reduced the NRS scores during movement. In addition, morphine equivalent consumption was lower in the PSP group compared to the PS group. Postoperative adverse events were similar in both groups in terms of regional anesthesia-related complications.
Conclusion


The combination of PECS I block, SIPB, and PSI block provides superior pain relief and postoperative recovery for patients undergoing MRM.",2020,"Although there were no differences in the NRS scores between the two groups during the inactive periods, the combination of three nerve blocks significantly reduced the NRS scores during movement.","['Patients and Methods\n\n\nSixty-two adult females undergoing', 'patients undergoing MRM']","['PSI with PECS I and SIPB', 'Modified Radical Mastectomy', 'I (PECS I) and serratus-intercostal plane block (SIPB', 'Employing Pectoral Nerve Block I and Serratus-Intercostal Block', 'PECS I and SIPB (PS group, n=31) or a combination of PECS I, SIPB, and PSI (PSP', 'PECS I block, SIPB, and PSI block', 'Pectoral nerve block', 'unilateral modified radical mastectomy (MRM']","['numerical rating scale (NRS) score, and in terms of opioid consumption and anesthesia-related complications', 'Postoperative adverse events', 'NRS scores', 'morphine equivalent consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}]","[{'cui': 'C0442146', 'cui_str': 'Parasternal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038868', 'cui_str': 'Progressive supranuclear palsy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]",62.0,0.157457,"Although there were no differences in the NRS scores between the two groups during the inactive periods, the combination of three nerve blocks significantly reduced the NRS scores during movement.","[{'ForeName': 'Wen-Qin', 'Initials': 'WQ', 'LastName': 'Song', 'Affiliation': ""Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Ying-Cong', 'Initials': 'YC', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Xue-Shan', 'Initials': 'XS', 'LastName': 'Bu', 'Affiliation': ""Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Zhan', 'Affiliation': ""Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Zhong-Yuan', 'Initials': 'ZY', 'LastName': 'Xia', 'Affiliation': ""Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S237435']
2602,32431536,Usefulness of a Double-Blind Placebo-Controlled Response Test to Demonstrate Rapid Onset Analgesia with Phenytoin 10% Cream in Polyneuropathy.,"Purpose


Topical analgesics are an upcoming treatment option for neuropathic pain. In this observational study, we performed a double-blind placebo-controlled response test (DOBRET) in patients with polyneuropathy to determine the personalized analgesic effect of phenytoin 10% cream.
Patients and Methods


In a double-blind fashion, 12 consecutive adult patients with symmetrical painful polyneuropathy and equal pain intensity of ≥4 on the 11-point numerical rating scale (NRS) applied phenytoin10% cream on one painful area and a placebo cream on the corresponding contralateral area. We defined responders as patients who experienced a pain reduction ≥2 NRS points from baseline and ≥1 NRS point difference in pain reduction in favour of phenytoin 10% cream compared with placebo cream within 30 minutes after application. We also evaluated the percentage of pain reduction and frequency of 30% and 50% pain relief from baseline.
Results


Six patients (50%) were responders. Compared with placebo cream, pain reduction was higher in phenytoin 10% cream-applied areas with mean difference in pain reduction of 1.3 (95% CI: 1.1 to 1.8; p<0.001) on the NRS and mean percentage difference in pain reduction of 22% (95% CI: 13% to 32%; p =0.03). All responders had at least 30% pain reduction, and 4 out of 6 had at least 50% pain reduction in the phenytoin 10% cream applied area. All non-responders had less than 30% pain reduction. No side effects were reported.
Conclusion


A DOBRET is easy to perform, quickly identifies an analgesic effect in responders and could be a useful tool to personalize neuropathic pain treatment with topical formulations.",2020,"Compared with placebo cream, pain reduction was higher in phenytoin 10% cream-applied areas with mean difference in pain reduction of 1.3 (95% CI: 1.1 to 1.8; p<0.001) on the NRS and mean percentage difference in pain reduction of 22% (95% CI: 13% to 32%; p =0.03).","['neuropathic pain', '12 consecutive adult patients with symmetrical painful polyneuropathy and equal pain intensity of ≥4 on the 11-point numerical rating scale (NRS) applied phenytoin10% cream on one painful area and a', 'patients with polyneuropathy', 'Polyneuropathy']","['phenytoin 10% cream', 'placebo cream', 'phenytoin', 'Double-Blind Placebo', 'placebo-controlled response test (DOBRET', 'Phenytoin 10% Cream']","['pain reduction and frequency of 30% and 50% pain relief', 'pain reduction']","[{'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",12.0,0.285927,"Compared with placebo cream, pain reduction was higher in phenytoin 10% cream-applied areas with mean difference in pain reduction of 1.3 (95% CI: 1.1 to 1.8; p<0.001) on the NRS and mean percentage difference in pain reduction of 22% (95% CI: 13% to 32%; p =0.03).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kopsky', 'Affiliation': 'Institute for Neuropathic Pain, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander F J E', 'Initials': 'AFJE', 'LastName': 'Vrancken', 'Affiliation': 'Department of Neurology, Brain Centre University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Keppel Hesselink', 'Affiliation': 'Institute for Neuropathic Pain, Bosch En Duin, the Netherlands.'}, {'ForeName': 'Ruben P A', 'Initials': 'RPA', 'LastName': 'van Eijk', 'Affiliation': 'Department of Neurology, Brain Centre University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Nicolette C', 'Initials': 'NC', 'LastName': 'Notermans', 'Affiliation': 'Department of Neurology, Brain Centre University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}]",Journal of pain research,['10.2147/JPR.S243434']
2603,32431566,"Efficacy and safety of aerosol inhalation of recombinant human interferon α1b (IFNα1b) injection for noninfluenza viral pneumonia, a multicenter, randomized, double-blind, placebo-controlled trial.","Background


To investigate the efficacy and safety of aerosol inhalation of recombinant human interferon α1b (IFNα1b) injection for noninfluenza viral pneumonia.
Methods


One hundred sixty-four patients with noninfluenza viral pneumonia were divided into IFNα1b and control groups. The IFNα1b group received routine treatment + aerosol inhalation of recombinant human IFNα1b injection (50 μg × 2 injections, bid). The control group received routine treatment + IFN analog (two injections, bid). Overall response rate (ORR) of five kinds clinical symptoms. Further outcomes were daily average score and the response rate of each of the symptoms above.
Results


A total of 163 patients were included in the full analysis set (FAS) and 151 patients were included in the per-protocol set (PPS). After 7 days of treatment, ORR of clinical symptoms was higher in IFNα1b group than that in control group for both the FAS and PPS. Moreover, after 7 days of treatment, the daily score of three efficacy indexes including expectoration, respiratory rate, and pulmonary rales were improved. The ORRs for expectoration and pulmonary rales were higher in the IFNα1b group than in the control group ( P  < 0.05). There were no significant differences of the ORRs for coughing, chest pain and respiratory rate between the two groups ( P  > 0.05). The incidence of adverse events was 6.5% ( n  = 5) in IFNα1b group and 3.5% ( n  = 3) in control group ( P  > 0.05).
Conclusion


Aerosol inhalation of recombinant human IFNα1b is safe and it can improve the clinical symptoms of noninfluenza viral pneumonia.",2020,The ORRs for expectoration and pulmonary rales were higher in the IFNα1b group than in the control group ( P  < 0.05).,"['Methods\n\n\nOne hundred sixty-four patients with noninfluenza viral pneumonia', 'A total of 163 patients were included in the full analysis set (FAS) and 151 patients were included in the per-protocol set (PPS', 'noninfluenza viral pneumonia']","['placebo', 'recombinant human IFNα1b injection', 'recombinant human IFNα1b', 'recombinant human interferon α1b (IFNα1b) injection', 'IFNα1b', 'routine treatment + IFN analog']","['Overall response rate (ORR', 'daily score of three efficacy indexes including expectoration, respiratory rate, and pulmonary rales', 'ORR of clinical symptoms', 'ORRs for coughing, chest pain and respiratory rate', 'ORRs for expectoration and pulmonary rales', 'incidence of adverse events', 'response rate of each of the symptoms above']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032310', 'cui_str': 'Viral pneumonia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0034642', 'cui_str': 'Respiratory crackles'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",163.0,0.0927595,The ORRs for expectoration and pulmonary rales were higher in the IFNα1b group than in the control group ( P  < 0.05).,"[{'ForeName': 'Rongmeng', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': '1Department of Infectious Disease, Beijing Ditan Hospital, Capital Medical University, No. 8 East Jingshun Street, Chaoyang District, Beijing, 100015 China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': '1Department of Infectious Disease, Beijing Ditan Hospital, Capital Medical University, No. 8 East Jingshun Street, Chaoyang District, Beijing, 100015 China.'}, {'ForeName': 'Meihua', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': '1Department of Infectious Disease, Beijing Ditan Hospital, Capital Medical University, No. 8 East Jingshun Street, Chaoyang District, Beijing, 100015 China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Xue', 'Affiliation': '2Department of Respiratory\u2002Medicine, Beijing Chuiyangliu Hospital, Beijing, 100022 China.'}, {'ForeName': 'Yongxiang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""3Department of Respiratory\u2002Medicine, People's Hospital of Beijing Daxing District, Beijing, 102600 China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': ""3Department of Respiratory\u2002Medicine, People's Hospital of Beijing Daxing District, Beijing, 102600 China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': '4Department of Respiratory\u2002Medicine, Fuxing Hospital, Capital Medical University, Beijing, 100038 China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': '4Department of Respiratory\u2002Medicine, Fuxing Hospital, Capital Medical University, Beijing, 100038 China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Respiratory\u2002Medicine, Beijing Huairou District Hospital, Beijing, 101400 China.'}, {'ForeName': 'Qingrong', 'Initials': 'Q', 'LastName': 'Nie', 'Affiliation': 'Department of Respiratory\u2002Medicine, Liangxiang Hospital of Fangshan District, Beijing, 102401 China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Respiratory\u2002Medicine, Liangxiang Hospital of Fangshan District, Beijing, 102401 China.'}, {'ForeName': 'Xiuhong', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Department of Respiratory\u2002Medicine, Beijing Pinggu Hospital, Beijing, 101200 China.'}, {'ForeName': 'Xiaoyin', 'Initials': 'X', 'LastName': 'Shan', 'Affiliation': 'Department of Respiratory\u2002Medicine, Beijing Pinggu Hospital, Beijing, 101200 China.'}, {'ForeName': 'Weian', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': '8Department of Respiratory Medicine, Peking University Shougang Hospital, Beijing, 100144 China.'}, {'ForeName': 'Erming', 'Initials': 'E', 'LastName': 'Zhang', 'Affiliation': '8Department of Respiratory Medicine, Peking University Shougang Hospital, Beijing, 100144 China.'}, {'ForeName': 'Zuoqing', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory\u2002Medicine, Beijing Shijingshan Hospital, Beijing, 100043 China.'}, {'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory\u2002Medicine, Beijing Shijingshan Hospital, Beijing, 100043 China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': '10Department of Respiratory Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070 China.'}, {'ForeName': 'Baozeng', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': '11Department of Infectious Disease, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070 China.'}, {'ForeName': 'Shuwen', 'Initials': 'S', 'LastName': 'Dong', 'Affiliation': '10Department of Respiratory Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070 China.'}, {'ForeName': 'Jiandong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': '12Department of Respiratory\u2002Medicine, General Hospital of Beijing Military Region, Beijing, 100700 China.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': '13Department of Infectious Disease, Peking University Third Hospital, Beijing, 100191 China.'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': '1Department of Infectious Disease, Beijing Ditan Hospital, Capital Medical University, No. 8 East Jingshun Street, Chaoyang District, Beijing, 100015 China.'}]","Journal of inflammation (London, England)",['10.1186/s12950-020-00249-1']
2604,32431538,Feasibility of a Randomized Controlled Trial of Paediatric Interdisciplinary Pain Management Using Home-Based Telehealth.,"Purpose


Chronic pain is common in adolescents. Evidence-based guidelines recommend interdisciplinary treatment, but access is limited by geography. The development of hybrid programs utilizing both face-to-face and videoconference treatment may help overcome this. We developed a 7-week hybrid pediatric interdisciplinary pain program (Hybrid-PIPP) and wished to compare it to individual face-to-face sessions (Standard Care). Our objective was to test the feasibility of a protocol that used a matched pair un-blinded randomized controlled design to investigate the efficacy and cost-effectiveness of the Hybrid-PIPP compared to Standard Care.
Patients and Methods


Parent-adolescent dyads were recruited from tertiary pediatric clinics and matched by disability before randomization to minimize allocation bias. The adolescents (aged 11-17) had experienced primary pain for >3 months. Hybrid-PIPP involved 11 hrs of group therapy and 4 individual videoconference sessions. Standard care was provided by the same clinical team, using the same treatment model and similar intensity as the Hybrid-PIPP. The intention was to recruit participants for 3 Hybrid-PIPP groups with a comparison stream. Recruitment was ceased after 2 groups due to the high participant disability requiring more intensive intervention.
Results


Eighteen dyads were screened and 13 randomized (7 Hybrid-PIPP, 6 Standard Care, 2 unsuitable, 3 unallocated when the study was stopped). The study met a priori feasibility criteria for staff availability; recruitment rate; treatment completion; and data collection. Global satisfaction ratings were similar in both streams (SC median 7, range 5-9 and Hybrid-PIPP median 8.5, range 5-10). Challenges were identified in both streams. A future modified Hybrid-PIPP was considered acceptable if the intensity is increased to manage the high level of disability. Standard care was considered inefficient. No adverse events were reported.
Conclusion


The study determined that the protocol met a priori feasibility criteria, but to be practicable in a real world, health environment requires significant modifications.
Registration


ANZTR(ACTRN2614000489695).",2020,"No adverse events were reported.
","['adolescents (aged 11-17) had experienced primary pain for >3 months', 'Eighteen dyads were screened and 13 randomized', 'adolescents', 'Patients and Methods\n\n\nParent-adolescent dyads were recruited from tertiary pediatric clinics and matched by disability before randomization to minimize allocation bias']","['Paediatric Interdisciplinary Pain Management Using Home-Based Telehealth', 'hybrid pediatric interdisciplinary pain program (Hybrid-PIPP', 'Hybrid-PIPP']","['Global satisfaction ratings', 'efficacy and cost-effectiveness', 'adverse events']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0070798', 'cui_str': 'PtdIns(4,5)P2'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",18.0,0.0524501,"No adverse events were reported.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hilyard', 'Affiliation': ""Complex Pain Service, Perth Children's Hospital, Perth, Western Australia, Australia.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kingsley', 'Affiliation': ""Complex Pain Service, Perth Children's Hospital, Perth, Western Australia, Australia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sommerfield', 'Affiliation': ""Complex Pain Service, Perth Children's Hospital, Perth, Western Australia, Australia.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': ""Complex Pain Service, Perth Children's Hospital, Perth, Western Australia, Australia.""}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Bear', 'Affiliation': 'Department of Child Research, Child Adolescent Health Service, Perth, Western Australia, Australia.'}, {'ForeName': 'Noula', 'Initials': 'N', 'LastName': 'Gibson', 'Affiliation': ""Physiotherapy Department, Perth Children's Hospital, Perth, Western Australia, Australia.""}]",Journal of pain research,['10.2147/JPR.S217022']
2605,31542533,"SPECT-Guided LV Lead Placement for Incremental CRT Efficacy: Validated by a Prospective, Randomized, Controlled Study.",,2019,,[],['SPECT-Guided LV Lead Placement'],[],[],"[{'cui': 'C0040399', 'cui_str': 'SPECT'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",[],,0.0425024,,"[{'ForeName': 'Jiangang', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hua', 'Affiliation': ''}, {'ForeName': 'Yangang', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Liangrong', 'Initials': 'L', 'LastName': 'Zhen', 'Affiliation': ''}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Xinbing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': ''}, {'ForeName': 'Jiefu', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yugang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Zuoying', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': ''}, {'ForeName': 'Qijun', 'Initials': 'Q', 'LastName': 'Shan', 'Affiliation': ''}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': ''}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Gu', 'Affiliation': ''}, {'ForeName': 'Yuanhao', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'Hongping', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Zhongqiang', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Yongyue', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Kejiang', 'Initials': 'K', 'LastName': 'Cao', 'Affiliation': ''}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2019.07.009']
2606,32431631,Increased Anxiety After Stimulation of the Right Inferior Parietal Lobe and the Left Orbitofrontal Cortex.,"Sustained anxiety is a key symptom of anxiety disorders and may be associated with neural activation in the right inferior parietal lobe (rIPL), particularly under unpredictable threat. This finding suggests a moderating role of the rIPL in sustained anxiety, which we tested in the current study. We applied cathodal or sham transcranial direct current stimulation (tDCS) to the rIPL as a symptom provocation method in 22 healthy participants in a randomized, double-blind, crossover study, prior to two recordings of cerebral blood flow (CBF). In between, we applied a threat-of-shock paradigm with three conditions: unpredictable (U), predictable (P), or no electric shocks (N). We hypothesized increased anxiety under U, but not under P or N. Furthermore, we expected reduced CBF in the rIPL after tDCS compared to sham. As predicted, anxiety was higher in the U than the P and N conditions, and active tDCS augmented this effect. While tDCS did not alter CBF in the rIPL, it did attenuate the observed increase in brain regions that typically increase activation as a response to anxiety. These findings suggest that the rIPL moderates sustained anxiety as a gateway to brain regions crucial in anxiety. Alternatively, anodal tDCS over the left orbitofrontal cortex (lOFC) may have increased anxiety through disruption of OFC-amygdala interactions.",2020,"As predicted, anxiety was higher in the U than the P and N conditions, and active tDCS augmented this effect.",['22 healthy participants'],"['cathodal or sham transcranial direct current stimulation (tDCS', 'anodal tDCS']","['Increased Anxiety', 'cerebral blood flow (CBF', 'anxiety', 'anxiety under U']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}]",22.0,0.0326354,"As predicted, anxiety was higher in the U than the P and N conditions, and active tDCS augmented this effect.","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Grieder', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Homan', 'Affiliation': 'Center for Psychiatric Neuroscience, Feinstein Institute for Medical Research, Manhasset, NY, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Federspiel', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Kiefer', 'Affiliation': 'Institute of Diagnostic and Interventional Neuroradiology, University Hospital Bern, Bern, Switzerland.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Hasler', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00375']
2607,32431621,"Effects of in Season Multi-Directional Plyometric Training on Vertical Jump Performance, Change of Direction Speed and Dynamic Postural Control in U-21 Soccer Players.","The aim of the study was to assess the effects of multi-directional plyometric training (MPT) on vertical jump height, change of direction speed (CODS), and dynamic postural control (DPC) of soccer players under 21 year (U-21). Twenty-seven male soccer players were randomly allocated to either an experimental group (EG;  n  = 14; age: 19.0 ± 0.9 years) or a control group (CG;  n  = 13; age: 19.0 ± 0.7 years). The EG introduced 6 weeks MPT, 2 days per week into their in-season training, while CG continued training without change. Measurements of vertical jump height, CODS and DPC were completed at the beginning and end of the 6 week MPT. ANOVA demonstrated a significant group × time interaction for SJ ( F  = 6.03,  p  = 0.021), CMJ ( F  = 9.10,  p  = 0.006), and  T -Test ( F  = 10.46,  p  = 0.002). The Bonferroni  Post Hoc  test demonstrated significant increase for the three tests in both group (EG and CG). For SJ (EG:  p  < 0.001; CG:  p  < 0.001), CMJ (EG:  p  < 0.001; CG:  p  = 0.005) and  T -Test (EG:  p  < 0.001; CG:  p  = 0.02). For DPC on the dominant leg, there was a significant group × time interaction for four axes [anterior ( F  = 5.48,  p  = 0.028), antero-lateral ( F  = 4.82,  p  = 0.038), postero-lateral ( F  = 4.82,  p  = 0.038), and medial ( F  = 6.77,  p  = 0.015)]. The Bonferroni  Post Hoc  test demonstrated significant increase in EG ( p  < 0.001), but no significant change in CG in four axes (anterior, antero-lateral, postero-lateral and medial). Furthermore DPC on the non-dominant leg, there was a significant group × time interaction for three axes [lateral ( F  = 8.09,  p  = 0.009), postero-lateral ( F  = 11.92,  p  = 0.002), and medial ( F  = 5.84,  p  = 0.023)]. The Bonferroni  Post Hoc  test demonstrated significant increase in EG ( p  < 0.001), but no significant change in CG in three axes (lateral, postero-lateral, and medial). In conclusion, incorporating MPT into the in-season regimen of under 21 soccer players improved performance of various indices related to soccer activity (i.e., CMJ, CODS, and DPC). MPT has the potential to be appealing to coaches, as it requires little time while yielding valuable results in the physical preparation of soccer players.",2020,"ANOVA demonstrated a significant group × time interaction for SJ ( F  = 6.03,  p  = 0.021), CMJ ( F  = 9.10,  p  = 0.006), and  T -Test ( F  = 10.46,  p  = 0.002).","['U-21 Soccer Players', 'Twenty-seven male soccer players', 'soccer players under 21 year (U-21']","['multi-directional plyometric training (MPT', 'Season Multi-Directional Plyometric Training', 'MPT']","['Vertical Jump Performance, Change of Direction Speed and Dynamic Postural Control', 'postero-lateral', 'EG', 'T -Test', 'performance of various indices related to soccer activity (i.e., CMJ, CODS, and DPC', 'vertical jump height, change of direction speed (CODS), and dynamic postural control (DPC', 'vertical jump height, CODS and DPC', 'time interaction for SJ']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",27.0,0.0172297,"ANOVA demonstrated a significant group × time interaction for SJ ( F  = 6.03,  p  = 0.021), CMJ ( F  = 9.10,  p  = 0.006), and  T -Test ( F  = 10.46,  p  = 0.002).","[{'ForeName': 'Mohamed Chedly', 'Initials': 'MC', 'LastName': 'Jlid', 'Affiliation': 'Research Unit (UR17JS01) Sport Performance, Health and Society, Higher Institute of Sport and Physical Education of Ksar Said, University of Manouba, Tunis, Tunisia.'}, {'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Coquart', 'Affiliation': 'CETAPS, EA3832, UFR STAPS, Université de Rouen Normandie, Rouen, France.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Maffulli', 'Affiliation': 'Centre for Sports and Exercise Medicine, Mile End Hospital, Barts and The London School of Medicine and Dentistry, London, United Kingdom.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Paillard', 'Affiliation': ""Laboratoire Mouvement, Equilibre, Performance et Santé (EA 4445), Département STAPS, Université de Pau et des Pays de l'Adour, Tarbes, France.""}, {'ForeName': 'Gian Nicola', 'Initials': 'GN', 'LastName': 'Bisciotti', 'Affiliation': 'Athlete Health and Performance Research Centre, ASPETAR, Qatar Orthopaedic and Sports Medicine Hospital, Doha, Qatar.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Chamari', 'Affiliation': 'Athlete Health and Performance Research Centre, ASPETAR, Qatar Orthopaedic and Sports Medicine Hospital, Doha, Qatar.'}]",Frontiers in physiology,['10.3389/fphys.2020.00374']
2608,32431622,DI-5-CUFFS: Venoconstrictive Thigh Cuffs Limit Body Fluid Changes but Not Orthostatic Intolerance Induced by a 5-Day Dry Immersion.,"Venoconstrictive thigh cuffs are used by cosmonauts to ameliorate symptoms associated with cephalad fluid shift. A ground simulation of microgravity, using the dry immersion (DI) model, was performed to assess the effects of thigh cuffs on body fluid changes and dynamics, as well as on cardiovascular deconditioning. Eighteen healthy men (25-43 years), randomly divided into two groups, (1) control group or (2) group with thigh cuffs worn 10 h/day, underwent 5-day DI. Cardiovascular responses to orthostatic challenge were evaluated using the lower body negative pressure (LBNP) test; body fluid changes were assessed by bio-impedance and hormonal assay; plasma volume evolution was estimated using hemoglobin-hematocrit; subjective tolerance was assessed by questionnaires. DI induced a decrease in plasma volume of 15-20%. Reduction in total body water of 3-6% stabilized toward the third day of DI. This reduction was derived mostly from the extracellular compartment. During the acute phase of DI, thigh cuffs limited the decrease in renin and the increase in N-terminal prohormone of brain natriuretic peptide (NT-proBNP), the loss in total body water, and tended to limit the loss in calf volume, extracellular volume and plasma volume. At the later stable phase of DI, a moderate protective effect of thigh cuffs remained evident on the body fluids. Orthostatic tolerance time dropped after DI without significant difference between groups. Thigh cuff countermeasure slowed down and limited the loss of body water and tended to limit plasma loss induced by DI. These observed physiological responses persisted during periods when thigh cuffs were removed. However, thigh cuffs did not counteract decreased tolerance to orthostatic challenge.",2020,Orthostatic tolerance time dropped after DI without significant difference between groups.,['Eighteen healthy men (25-43 years'],"['control group or (2) group with thigh cuffs worn 10 h/day, underwent 5-day DI', 'DI-5-CUFFS']","['lower body negative pressure (LBNP) test; body fluid changes', 'Orthostatic tolerance time', 'plasma volume', 'tolerance to orthostatic challenge', 'moderate protective effect of thigh cuffs']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0024047', 'cui_str': 'Negative lower body pressure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}]",18.0,0.0130344,Orthostatic tolerance time dropped after DI without significant difference between groups.,"[{'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Robin', 'Affiliation': ""Centre de Recherche Clinique, CHU d'Angers, Angers, France.""}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Auvinet', 'Affiliation': ""Centre de Recherche Clinique, CHU d'Angers, Angers, France.""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Degryse', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Bareille', 'Affiliation': 'MEDES, Toulouse, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'MEDES, Toulouse, France.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Gharib', 'Affiliation': 'Faculté de Médecine Lyon-Est, Institut NeuroMyoGène, Université de Lyon, Lyon, France.'}, {'ForeName': 'Guillemette', 'Initials': 'G', 'LastName': 'Gauquelin-Koch', 'Affiliation': ""Centre National d'Etudes Spatiales, Paris, France.""}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Daviet', 'Affiliation': ""Laboratoire de Biochimie, CHU d'Angers, Angers, France.""}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Larcher', 'Affiliation': ""Laboratoire de Biochimie, CHU d'Angers, Angers, France.""}, {'ForeName': 'Marc-Antoine', 'Initials': 'MA', 'LastName': 'Custaud', 'Affiliation': ""Centre de Recherche Clinique, CHU d'Angers, Angers, France.""}, {'ForeName': 'Nastassia', 'Initials': 'N', 'LastName': 'Navasiolava', 'Affiliation': ""Centre de Recherche Clinique, CHU d'Angers, Angers, France.""}]",Frontiers in physiology,['10.3389/fphys.2020.00383']
2609,32431643,The SUPPORT-S Protocol Study: A Postvention Program for Professionals After Patient or User Suicide.,"Background


Exposure to patient or user suicide (PUS) is identified as a challenging occupational hazard for mental health and social work professionals. Professionals exposed to PUS may encounter several ranges of emotional, traumatic or professional impacts in the aftermath. A high proportion of exposed professionals reports a lack of support in the aftermath of PUS. SUPPORT is a postvention program designed to provide a comprehensive, adaptative and effective support to professionals impacted by PUS. The aims of the SUPPORT-S study are to (1) improve the design of the SUPPORT program, (2) evaluate the effectiveness of the program to buffer the emotional, traumatic and professional impacts and to improve the perceived social support for professionals exposed to PUS, and (3) provide more insights into the consequences of PUS on both professionals and organizations.
Method


The SUPPORT-S study is a mixed method collaborative and participatory action research. The simultaneous and complementary collection and analysis of qualitative and quantitative data will offer an in-depth evaluation of the implementation and the effectiveness of the program. The qualitative evaluation includes: (a) an ethnographic observation; (b) 25 semi-directed interviews with randomized participants; (c) an activity analysis with providers of the program; and (d) collaborative sharing of the results with providers and participants. The quantitative evaluation includes pre- and post-measures in participants of: (a) emotional impact ( Differential Emotions Scale IV ); (b) traumatic impact ( Impact of Event Scale-Revised ); (c) professional impact (non-validated questionnaire); and (d) perceived social support ( Perceived Social Support Scale for Professionals ). The action research design will rely on: (a) the cycling process of implementation/evaluation/data sharing/adjustment and (b) the participatory approach through data sharing with providers and participants. Triangulation, saturation, randomization, and participatory design will also reduce the risk of biases and will improve the generalizability of conclusions.
Expected Results


We expect the SUPPORT-S study to evaluate and improve the design of the SUPPORT program to effectively help professionals to cope with PUS.
Conclusion


The results of the study will allow us to disseminate an effective and adaptive postvention program for professionals and institutions encountering PUS.",2020,"We expect the SUPPORT-S study to evaluate and improve the design of the SUPPORT program to effectively help professionals to cope with PUS.
","['Professionals', 'participants of: (a']",['\n\n\nExposure to patient or user suicide (PUS'],['emotional impact ( Differential Emotions Scale IV ); (b) traumatic impact ( Impact of Event Scale-Revised ); (c) professional impact (non-validated questionnaire); and (d) perceived social support ( Perceived Social Support Scale for Professionals '],[],"[{'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C3472482', 'cui_str': 'Impact of event scale revised'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",,0.0341276,"We expect the SUPPORT-S study to evaluate and improve the design of the SUPPORT program to effectively help professionals to cope with PUS.
","[{'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Leaune', 'Affiliation': 'Center for Suicide Prevention, Centre Hospitalier le Vinatier, Bron, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cuvillier', 'Affiliation': 'Groupe de Recherche en Psychologie Sociale, Lumière Lyon 2 University, Lyon, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Vieux', 'Affiliation': 'Center for Suicide Prevention, Centre Hospitalier le Vinatier, Bron, France.'}, {'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Pacaut-Troncin', 'Affiliation': 'Center for Suicide Prevention, Centre Hospitalier le Vinatier, Bron, France.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Chalancon', 'Affiliation': 'Center for Suicide Prevention, Centre Hospitalier le Vinatier, Bron, France.'}, {'ForeName': 'Anne-Fleur', 'Initials': 'AF', 'LastName': 'Perez', 'Affiliation': 'Institut Régional Jean Bergeret, Centre Hospitalier Saint-Jean de Dieu, Lyon, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Haesebaert', 'Affiliation': 'EA 7425 HESPER Health Services and Performance Research - Claude Bernard Lyon 1 University, Lyon, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Chauliac', 'Affiliation': 'Center for Suicide Prevention, Centre Hospitalier le Vinatier, Bron, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Poulet', 'Affiliation': 'Center for Suicide Prevention, Centre Hospitalier le Vinatier, Bron, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Durif-Bruckert', 'Affiliation': 'Groupe de Recherche en Psychologie Sociale, Lumière Lyon 2 University, Lyon, France.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00805']
2610,30914378,Integrative analysis of the intestinal metabolome of childhood asthma.,"BACKGROUND


The intestinal metabolome reflects the biological consequences of diverse exposures and might provide insight into asthma pathophysiology.
OBJECTIVE


We sought to perform an untargeted integrative analysis of the intestinal metabolome of childhood asthma in this ancillary study of the Vitamin D Antenatal Asthma Reduction Trial.
METHODS


Metabolomic profiling was performed by using mass spectrometry on fecal samples collected from 361 three-year-old subjects. Adjusted logistic regression analyses identified metabolites and modules of highly correlated metabolites associated with asthma diagnosis by age 3 years. Sparse canonical correlation analysis identified associations relevant to asthma between the intestinal metabolome and other ""omics"": the intestinal microbiome as measured by using 16S rRNA sequencing, the plasma metabolome as measured by using mass spectrometry, and diet as measured by using food frequency questionnaires.
RESULTS


Several intestinal metabolites were associated with asthma at age 3 years, including inverse associations between asthma and polyunsaturated fatty acids (adjusted logistic regression β = -6.3; 95% CI, -11.3 to -1.4; P = .01) and other lipids. Asthma-associated intestinal metabolites were significant mediators of the inverse relationship between exclusive breast-feeding for the first 4 months of life and asthma (P for indirect association = .04) and the positive association between a diet rich in meats and asthma (P = .03). Specific intestinal bacterial taxa, including the family Christensenellaceae, and plasma metabolites, including γ-tocopherol/β-tocopherol, were positively associated with asthma and asthma-associated intestinal metabolites.
CONCLUSION


Integrative analyses revealed significant interrelationships between the intestinal metabolome and the intestinal microbiome, plasma metabolome, and diet in association with childhood asthma. These findings require replication in future studies.",2019,"RESULTS


Several intestinal metabolites were associated with asthma at age 3 years, including inverse associations between asthma and polyunsaturated fatty acids (adjusted logistic regression β = -6.3; 95% CI, -11.3 to -1.4; P = .01) and other lipids.","['361 three-year-old subjects', 'childhood asthma']",[],[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}]",[],[],,0.0267051,"RESULTS


Several intestinal metabolites were associated with asthma at age 3 years, including inverse associations between asthma and polyunsaturated fatty acids (adjusted logistic regression β = -6.3; 95% CI, -11.3 to -1.4; P = .01) and other lipids.","[{'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Lee-Sarwar', 'Affiliation': ""Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass. Electronic address: klee-sarwar@partners.org.""}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Kelly', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lasky-Su', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Zeiger', 'Affiliation': 'Departments of Allergy and Research and Evaluation, Kaiser Permanente Southern California, San Diego and Pasadena, Calif.'}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': ""O'Connor"", 'Affiliation': 'Pulmonary Center and Department of Medicine, Boston University School of Medicine, Boston, Mass.'}, {'ForeName': 'Megan T', 'Initials': 'MT', 'LastName': 'Sandel', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston, Mass.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': ""Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St Louis, and St Louis Children's Hospital, St Louis, Mo.""}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Beigelman', 'Affiliation': ""Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St Louis, and St Louis Children's Hospital, St Louis, Mo.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Laranjo', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Gold', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass; Department of Environmental Health, Harvard T. H. Chan School of Public Health, Boston, Mass.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': ""Division of Pediatric Pulmonary Medicine, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY. Electronic address: augusto_litonjua@urmc.rochester.edu.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.02.032']
2611,19291787,Evolution of hepatic steatosis in patients with advanced hepatitis C: results from the hepatitis C antiviral long-term treatment against cirrhosis (HALT-C) trial.,"UNLABELLED


Hepatic steatosis is a common histologic feature in patients with chronic hepatitis C (CHC) but there are no large longitudinal studies describing the progression of steatosis in CHC. We examined changes in steatosis on serial biopsies among CHC patients participating in the Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial. All 1050 patients in the trial had advanced fibrosis at baseline biopsy and were documented not to have had a sustained virological response to peginterferon and ribavirin. Most (94%) patients had genotype 1 infection. At least one protocol follow-up biopsy was read on 892 patients, and 699 had the last biopsy performed 3.5 years after randomization. At enrollment, 39% had cirrhosis and 61% had bridging fibrosis; 18%, 41%, 31%, and 10% had steatosis scores of 0, 1, 2, and 3 or 4, respectively. The mean steatosis score decreased in the follow-up biopsies in both the interferon-treated patients and controls with no effect of treatment assignment (P = 0.66). A decrease in steatosis score by > or =1 point was observed in 30% of patients and was associated with both progression to cirrhosis and continued presence of cirrhosis (P = 0.02). Compared to patients without a decrease in steatosis, those with a decrease in steatosis had worse metabolic parameters at enrollment, and were more likely to have a decrease in alcohol intake, improvement in metabolic parameters, and worsening liver disease (cirrhosis, esophageal varices, and deterioration in liver function).
CONCLUSION


Serial biopsies demonstrated that in patients with CHC, steatosis recedes during progression from advanced fibrosis to cirrhosis. Decreased alcohol intake and improved metabolic parameters are associated with a decline in steatosis and may modulate hepatitis C progression.",2009,The mean steatosis score decreased in the follow-up biopsies in both the interferon-treated patients and controls with no effect of treatment assignment (P = 0.66).,"['patients with advanced hepatitis C', 'patients with chronic hepatitis C (CHC', 'CHC patients participating in the Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial']",['peginterferon and ribavirin'],"['mean steatosis score', 'advanced fibrosis', 'alcohol intake, improvement in metabolic parameters, and worsening liver disease (cirrhosis, esophageal varices, and deterioration in liver function', 'Decreased alcohol intake and improved metabolic parameters', 'bridging fibrosis', 'steatosis score', 'steatosis', 'sustained virological response', 'steatosis scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0524910', 'cui_str': 'Hepatitis C, Chronic'}, {'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]","[{'cui': 'C0035525', 'cui_str': 'Ribavirin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0014867', 'cui_str': 'Esophageal Varices'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0334160', 'cui_str': 'Bridging fibrosis (morphologic abnormality)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}]",1050.0,0.0661889,The mean steatosis score decreased in the follow-up biopsies in both the interferon-treated patients and controls with no effect of treatment assignment (P = 0.66).,"[{'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Lok', 'Affiliation': 'Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI 48109, USA. aslok@med.umich.edu'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Everhart', 'Affiliation': ''}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Hae-Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Everson', 'Affiliation': ''}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Hoefs', 'Affiliation': ''}, {'ForeName': 'Joel K', 'Initials': 'JK', 'LastName': 'Greenson', 'Affiliation': ''}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Sterling', 'Affiliation': ''}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Lindsay', 'Affiliation': ''}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Adrian M', 'Initials': 'AM', 'LastName': 'Di Bisceglie', 'Affiliation': ''}, {'ForeName': 'Herbert L', 'Initials': 'HL', 'LastName': 'Bonkovsky', 'Affiliation': ''}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Ghany', 'Affiliation': ''}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Morishima', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hepatology (Baltimore, Md.)",['10.1002/hep.22865']
2612,30063180,Noradrenergic and Cholinergic Modulation of Belief Updating.,"To make optimal predictions in a dynamic environment, the impact of new observations on existing beliefs-that is, the learning rate-should be guided by ongoing estimates of change and uncertainty. Theoretical work has proposed specific computational roles for various neuromodulatory systems in the control of learning rate, but empirical evidence is still sparse. The aim of the current research was to examine the role of the noradrenergic and cholinergic systems in learning rate regulation. First, we replicated our recent findings that the centroparietal P3 component of the EEG-an index of phasic catecholamine release in the cortex-predicts trial-to-trial variability in learning rate and mediates the effects of surprise and belief uncertainty on learning rate (Study 1,  n  = 17). Second, we found that pharmacological suppression of either norepinephrine or acetylcholine activity produced baseline-dependent effects on learning rate following nonobvious changes in an outcome-generating process (Study 1). Third, we identified two genes, coding for α2A receptor sensitivity ( ADRA2A ) and norepinephrine reuptake ( NET ), as promising targets for future research on the genetic basis of individual differences in learning rate (Study 2,  n  = 137). Our findings suggest a role for the noradrenergic and cholinergic systems in belief updating and underline the importance of studying interactions between different neuromodulatory systems.",2018,"Second, we found that pharmacological suppression of either norepinephrine or acetylcholine activity produced baseline-dependent effects on learning rate following nonobvious changes in an outcome-generating process (Study 1).",[],"['norepinephrine reuptake ( NET ', 'norepinephrine or acetylcholine activity']",['learning rate'],[],"[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.0232653,"Second, we found that pharmacological suppression of either norepinephrine or acetylcholine activity produced baseline-dependent effects on learning rate following nonobvious changes in an outcome-generating process (Study 1).","[{'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Jepma', 'Affiliation': 'Leiden University.'}, {'ForeName': 'Stephen B R E', 'Initials': 'SBRE', 'LastName': 'Brown', 'Affiliation': 'Leiden University.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Murphy', 'Affiliation': 'Leiden University.'}, {'ForeName': 'Stephany C', 'Initials': 'SC', 'LastName': 'Koelewijn', 'Affiliation': 'Leiden University Medical Centre.'}, {'ForeName': 'Boukje', 'Initials': 'B', 'LastName': 'de Vries', 'Affiliation': 'Leiden University Medical Centre.'}, {'ForeName': 'Arn M', 'Initials': 'AM', 'LastName': 'van den Maagdenberg', 'Affiliation': 'Leiden University Medical Centre.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Nieuwenhuis', 'Affiliation': 'Leiden University.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01317']
2613,32430507,"Impact of Myc in HIV-associated Non-Hodgkin Lymphomas Treated with EPOCH, and Outcomes with Vorinostat (AMC075 Trial).","EPOCH is a preferred regimen for HIV-NHLs, which are frequently EBV+ or HHV-8+. The histone deacetylase (HDAC) inhibitor vorinostat disrupts EBV/HHV-8 latency, enhances chemotherapy-induced cell death, and may clear HIV reservoirs. To assess whether vorinostat increases EPOCH efficacy and/or HIV clearance we performed a randomized phase 2 study in 90 patients (45 per arm) with aggressive HIV-NHLs using dose-adjusted EPOCH (plus rituximab if CD20+) alone or with vorinostat 300 mg administered on days 1-5 of each cycle. Up to 1 prior cycle of systemic chemotherapy was allowed. The primary endpoint was complete response (CR). In 86 evaluable patients with diffuse large B-cell lymphoma (n=61), plasmablastic lymphoma (n=15), primary effusion lymphoma (n=7), unclassifiable B-cell NHL (n=2), and Burkitt lymphoma (n=1), CR rates were 74% versus 68% for EPOCH versus EPOCH-vorinostat, respectively (1-sided P=0.72). Patients with CD4+ count <200 cells/mm3 had a lower CR rate. EPOCH-vorinostat did not eliminate HIV reservoirs and resulted in more frequent grade 4 neutropenia and thrombocytopenia (47% and 29%, respectively) versus EPOCH (20% and 2%, respectively). The overall and event-free survival (EFS) rates were similar between arms. Overall, patients with Myc+ DLBCL had significantly lower EFS (44% at 3-yr, versus 83% in Myc- DLBCL). Low diagnosis-to-treatment interval (DTI) was also associated with inferior outcomes, while pre-protocol therapy had no negative impact. In conclusion, EPOCH had broad efficacy against highly aggressive HIV-NHLs, while vorinostat had no benefit; patients with Myc-driven DLBCL, low CD4, and low DTI had less favorable outcomes. Permitting pre-protocol therapy facilitated accruals without compromising outcomes. NCT0119384.",2020,The overall and event-free survival (EFS) rates were similar between arms.,"['86 evaluable patients with diffuse large B-cell lymphoma (n=61), plasmablastic lymphoma (n=15), primary effusion lymphoma (n=7), unclassifiable B-cell NHL (n=2), and Burkitt lymphoma (n=1', '90 patients (45 per arm) with aggressive HIV-NHLs using dose']",['adjusted EPOCH (plus rituximab if CD20+) alone or with vorinostat 300 mg administered on days 1-5 of each cycle'],"['CR rates', 'EPOCH efficacy', 'complete response (CR', 'Low diagnosis-to-treatment interval (DTI', 'EFS', 'overall and event-free survival (EFS) rates', 'and/or HIV clearance', 'frequent grade 4 neutropenia and thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0079746', 'cui_str': ""Diffuse non-Hodgkin's lymphoma, immunoblastic (clinical)""}, {'cui': 'C1292753', 'cui_str': 'Primary effusion lymphoma'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0006413', 'cui_str': 'Burkitt lymphoma'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",90.0,0.175059,The overall and event-free survival (EFS) rates were similar between arms.,"[{'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Ramos', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, Florida, United States.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore Medical Center, Bronx, New York, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chadburn', 'Affiliation': 'Weill Cornell Medical College, New York, New York, United States.'}, {'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Reid', 'Affiliation': 'Moores UCSD Cancer Center, La Jolla, California, United States.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Ambinder', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Siegel', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States.'}, {'ForeName': 'Page C', 'Initials': 'PC', 'LastName': 'Moore', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Rubinstein', 'Affiliation': 'John H. Stroger Hospital of Cook County, Chicago, Illinois, United States.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Durand', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Ethel', 'Initials': 'E', 'LastName': 'Cesarman', 'Affiliation': 'Weill Cornell Medicine, New York, New York, United States.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Aboulafia', 'Affiliation': 'Virginia Mason Medical Center, Seattle, Washington, United States.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Baiocchi', 'Affiliation': 'Ohio State University, Colmubus, Ohio, United States.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ratner', 'Affiliation': 'Washington University, St. Louis, Missouri, United States.'}, {'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Kaplan', 'Affiliation': 'University of California, San Francisco, San Francisco, California, United States.'}, {'ForeName': 'Adam A', 'Initials': 'AA', 'LastName': 'Capoferri', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, United States.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'U. of Arkansas for Medical Sciences, :Little Rock, Arkansas, United States.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Mitsuyasu', 'Affiliation': 'UCLA, Los Angeles, California, United States.'}, {'ForeName': 'Ariela', 'Initials': 'A', 'LastName': 'Noy', 'Affiliation': 'Weill Cornell Medicine, United States.'}]",Blood,['10.1182/blood.2019003959']
2614,32431658,Gait and Functional Mobility in Multiple Sclerosis: Immediate Effects of Transcranial Direct Current Stimulation (tDCS) Paired With Aerobic Exercise.,"Walking impairments are a debilitating feature of multiple sclerosis (MS) because of the direct interference with daily activity. The management of motor symptoms in those with MS remains a therapeutic challenge. Transcranial direct current stimulation (tDCS) is a type of non-invasive brain stimulation that is emerging as a promising rehabilitative tool but requires further characterization to determine its optimal therapeutic use. In this randomized, sham-controlled proof-of-concept study, we tested the immediate effects of a single tDCS session on walking and functional mobility in those with MS. Seventeen participants with MS completed one 20-min session of aerobic exercise, randomly assigned to be paired with either active (2.5 mA,  n  = 9) or sham ( n  = 8) tDCS over the primary motor cortex (M1). The groups (active vs. sham) were matched according to gender (50% vs. 60% F), age (52.1 ± 12.85 vs. 54.2 ± 8.5 years), and level of neurological disability (median Expanded Disability Status Scale score 5.5 vs. 5). Gait speed on the 10-m walk test and the Timed Up and Go (TUG) time were measured by a wearable inertial sensor immediately before and following the 20-min session, with changes compared between conditions and time. There were no significant differences in gait speed or TUG time changes following the session in the full sample or between the active vs. sham groups. These findings suggest that a single session of anodal tDCS over M1 is not sufficient to affect walking and functional mobility in those with MS. Instead, behavioral motor response of tDCS is likely to be cumulative, and the effects of multiple tDCS sessions require further study.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier: NCT03658668.",2020,There were no significant differences in gait speed or TUG time changes following the session in the full sample or between the active vs. sham groups.,"['Seventeen participants with MS completed one 20-min session of', 'Multiple Sclerosis']","['aerobic exercise, randomly assigned to be paired with either active (2.5 mA,  n  = 9) or sham ( n  = 8) tDCS', 'Transcranial direct current stimulation (tDCS', 'single tDCS session', 'Transcranial Direct Current Stimulation (tDCS) Paired With Aerobic Exercise']","['gait speed or TUG time changes', 'level of neurological disability (median Expanded Disability Status Scale score', 'walking and functional mobility', 'Gait speed on the 10-m walk test and the Timed Up and Go (TUG) time', 'Gait and Functional Mobility']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",17.0,0.0832236,There were no significant differences in gait speed or TUG time changes following the session in the full sample or between the active vs. sham groups.,"[{'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Pilloni', 'Affiliation': 'NYU Langone Health, Department of Neurology, New York, NY, United States.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'SUNY Downstate, Department of Medicine, New York, NY, United States.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Coghe', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Cocco', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Krupp', 'Affiliation': 'NYU Langone Health, Department of Neurology, New York, NY, United States.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Pau', 'Affiliation': 'Department of Mechanical, Chemical and Materials Engineering, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Leigh E', 'Initials': 'LE', 'LastName': 'Charvet', 'Affiliation': 'NYU Langone Health, Department of Neurology, New York, NY, United States.'}]",Frontiers in neurology,['10.3389/fneur.2020.00310']
2615,32430458,Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6-17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial.,"OBJECTIVE


To compare efficacy and safety of insulin glargine 300 units/mL (Gla-300) and 100 units/mL (Gla-100) in children and adolescents (6-17 years old) with type 1 diabetes.
RESEARCH DESIGN AND METHODS


EDITION JUNIOR was a noninferiority, international, open-label, two-arm, parallel-group, phase 3b trial. Participants were randomized 1:1 to Gla-300 or Gla-100, titrated to achieve fasting self-monitored plasma glucose levels of 90-130 mg/dL (5.0-7.2 mmol/L), with continuation of prior prandial insulin. The primary end point was change in HbA 1c  from baseline to week 26. Other assessments included change in fasting plasma glucose (FPG), hypoglycemia, hyperglycemia with ketosis, and adverse events.
RESULTS


In 463 randomized participants (Gla-300,  n  = 233; Gla-100,  n  = 230), comparable least squares (LS) mean (SE) reductions in HbA 1c  were observed from baseline to week 26 (-0.40% [0.06%] for both groups), with LS mean between-group difference of 0.004% (95% CI -0.17 to 0.18), confirming noninferiority at the prespecified 0.3% (3.3 mmol/mol) margin. Mean FPG change from baseline to week 26 was also similar between groups. During the 6-month treatment period, incidence and event rates of severe or documented (≤70 mg/dL [≤3.9 mmol/L]) hypoglycemia were similar between groups. Incidence of severe hypoglycemia was 6.0% with Gla-300 and 8.8% with Gla-100 (relative risk 0.68 [95% CI 0.35-1.30]). Incidence of any hyperglycemia with ketosis was 6.4% with Gla-300 and 11.8% with Gla-100.
CONCLUSIONS


Gla-300 provided similar glycemic control and safety profiles to Gla-100 in children and adolescents with type 1 diabetes, indicating that Gla-300 is a suitable therapeutic option in this population.",2020,"Gla-300 provided similar glycemic control and safety profiles to Gla-100 in children and adolescents with type 1 diabetes, indicating that Gla-300 is a suitable therapeutic option in this population.","['With Type 1 Diabetes', 'children and adolescents (6-17 years old) with type 1 diabetes', 'Children and Adolescents (6-17 years', 'children and adolescents with type 1 diabetes']","['insulin glargine 300 units/mL (Gla-300) and 100 units/mL (Gla-100', 'Gla-300', 'Insulin Glargine 300 Units/mL', 'Insulin Glargine 100 Units/mL (Gla-100', 'Gla-300 or Gla-100, titrated to achieve fasting self-monitored plasma glucose levels of 90-130 mg/dL']","['Efficacy and Safety', 'Mean FPG change', 'change in HbA 1c', 'fasting plasma glucose (FPG), hypoglycemia, hyperglycemia with ketosis, and adverse events', 'incidence and event rates of severe', 'Incidence of severe hypoglycemia', 'Incidence of any hyperglycemia with ketosis', 'hypoglycemia', 'efficacy and safety']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0022638', 'cui_str': 'Ketosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}]",463.0,0.0547279,"Gla-300 provided similar glycemic control and safety profiles to Gla-100 in children and adolescents with type 1 diabetes, indicating that Gla-300 is a suitable therapeutic option in this population.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Children's Hospital AUF DER BULT, Hannover Medical School, Hannover, Germany danne@hka.de.""}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Tamborlane', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Oleg A', 'Initials': 'OA', 'LastName': 'Malievsky', 'Affiliation': 'Department of Pediatrics, Bashkir State Medical University, Ufa, Russian Federation.'}, {'ForeName': 'Denise R', 'Initials': 'DR', 'LastName': 'Franco', 'Affiliation': 'CPCLIN Clinical Research Center, São Paulo, Brazil.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Kawamura', 'Affiliation': 'Department of Pediatrics, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Demissie', 'Affiliation': 'Sanofi, Frankfurt, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi, Frankfurt, Germany.'}, {'ForeName': 'Harmonie', 'Initials': 'H', 'LastName': 'Goyeau', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Wardecki', 'Affiliation': 'Sanofi, Warsaw, Poland.'}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""UMC - University Children's Hospital and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.""}]",Diabetes care,['10.2337/dc19-1926']
2616,31573644,Simulation and Clinical Competency in Undergraduate Nursing Programs: A Multisite Prospective Study.,"BACKGROUND


In prelicensure nursing education, there is a need to better understand the roles that simulation and traditional clinical instruction play in the development of clinical competence.
METHOD


A prospective cohort study was conducted across four prelicensure nursing programs. Four undergraduate nursing programs tested an intervention cohort with a redesign of the use of simulation, a redistribution of clinical hours, and an implementation of these new educational approaches into simulation experiences.
RESULTS


The final sample consisted of 271 control students and 315 intervention students who were assessed at the end of five clinical courses. There was no significant difference between the control and intervention groups on licensure examination pass rates and no uniform differences in clinical competency.
CONCLUSION


These findings suggest that the redistribution of clinical hours from traditional to simulation did not affect clinical competency or licensure examination results. Such redistributions have the potential to yield comparable results. [J Nurs Educ. 2019;58(10):561-568.].",2019,"There was no significant difference between the control and intervention groups on licensure examination pass rates and no uniform differences in clinical competency.
","['Undergraduate Nursing Programs', '271 control students and 315 intervention students who were assessed at the end of five clinical courses']",[],"['licensure examination pass rates', 'clinical competency']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0449259', 'cui_str': 'Clinical course'}]",[],"[{'cui': 'C0023637', 'cui_str': 'Licensure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008956', 'cui_str': 'Competence, Clinical'}]",,0.0224061,"There was no significant difference between the control and intervention groups on licensure examination pass rates and no uniform differences in clinical competency.
","[{'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Mancini', 'Affiliation': ''}, {'ForeName': 'Judy L', 'Initials': 'JL', 'LastName': 'LeFlore', 'Affiliation': ''}, {'ForeName': 'Daisha Jane', 'Initials': 'DJ', 'LastName': 'Cipher', 'Affiliation': ''}]",The Journal of nursing education,['10.3928/01484834-20190923-02']
2617,29706471,Subcutaneous advanced glycation end-products and lung function according to glucose abnormalities: The ILERVAS Project.,,2019,,[],[],[],[],[],[],,0.0125917,,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sánchez', 'Affiliation': 'Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova, Obesity, Diabetes and Metabolism research group (ODIM), IRBLleida, University of Lleida, Lleida, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lecube', 'Affiliation': 'Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova, Obesity, Diabetes and Metabolism research group (ODIM), IRBLleida, University of Lleida, Lleida, Spain; Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), Madrid, Spain. Electronic address: alecube@gmail.com.'}, {'ForeName': 'À', 'Initials': 'À', 'LastName': 'Betriu', 'Affiliation': 'Unit for the Detection and Treatment of Atherothrombotic Diseases (UDETMA V&R), University Hospital Arnau de Vilanova, Vascular and Renal Translational Research Group, IRBLleida, University of Lleida, Lleida, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hernández', 'Affiliation': ""Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), Madrid, Spain; Endocrinology and Nutrition Department, University Hospital Vall d'Hebron, Diabetes and Metabolism Research Unit, VHIR, Autonomous University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'López-Cano', 'Affiliation': 'Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova, Obesity, Diabetes and Metabolism research group (ODIM), IRBLleida, University of Lleida, Lleida, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gutiérrez-Carrasquilla', 'Affiliation': 'Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova, Obesity, Diabetes and Metabolism research group (ODIM), IRBLleida, University of Lleida, Lleida, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kerkeni', 'Affiliation': 'Higher Institute of Biotechnology, Laboratory of Biochemistry, Faculty of Medicine, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yeramian', 'Affiliation': 'Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova, Obesity, Diabetes and Metabolism research group (ODIM), IRBLleida, University of Lleida, Lleida, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Purroy', 'Affiliation': 'Stroke Unit, University Hospital Arnau de Vilanova, Clinical Neurosciences Group, IRBLleida, University of Lleida, Lleida, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pamplona', 'Affiliation': 'Metabolic Pathophysiology Group, IRBLleida, University of Lleida, Lleida, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Farràs', 'Affiliation': 'Borges Blanques Primary Health Care Unit, Borges Blanques, Lleida, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fernández', 'Affiliation': 'Unit for the Detection and Treatment of Atherothrombotic Diseases (UDETMA V&R), University Hospital Arnau de Vilanova, Vascular and Renal Translational Research Group, IRBLleida, University of Lleida, Lleida, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Barbé', 'Affiliation': 'Respiratory Department, University Hospital Arnau de Vilanova-Santa María, Translational Research in Respiratory Medicine, IRBLleida, University of Lleida, University Hospital Arnau de Vilanova, Lleida, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Simó', 'Affiliation': ""Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), Madrid, Spain; Endocrinology and Nutrition Department, University Hospital Vall d'Hebron, Diabetes and Metabolism Research Unit, VHIR, Autonomous University of Barcelona, Barcelona, Spain. Electronic address: rafael.simo@vhebron.net.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hernández', 'Affiliation': 'Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova, Obesity, Diabetes and Metabolism research group (ODIM), IRBLleida, University of Lleida, Lleida, Spain; Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rius', 'Affiliation': 'Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova, Obesity, Diabetes and Metabolism research group (ODIM), IRBLleida, University of Lleida, Lleida, Spain; Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Polanco', 'Affiliation': 'Respiratory Department, University Hospital Arnau de Vilanova-Santa María, Translational Research in Respiratory Medicine, IRBLleida, University of Lleida, University Hospital Arnau de Vilanova, Lleida, Spain.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'de la Torre', 'Affiliation': 'Respiratory Department, University Hospital Arnau de Vilanova-Santa María, Translational Research in Respiratory Medicine, IRBLleida, University of Lleida, University Hospital Arnau de Vilanova, Lleida, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Torres', 'Affiliation': 'Respiratory Department, University Hospital Arnau de Vilanova-Santa María, Translational Research in Respiratory Medicine, IRBLleida, University of Lleida, University Hospital Arnau de Vilanova, Lleida, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Godoy', 'Affiliation': 'Respiratory Department, University Hospital Arnau de Vilanova-Santa María, Translational Research in Respiratory Medicine, IRBLleida, University of Lleida, University Hospital Arnau de Vilanova, Lleida, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Portero-Otin', 'Affiliation': 'Metabolic Pathophysiology Group, IRBLleida, University of Lleida, Lleida, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jové', 'Affiliation': 'Metabolic Pathophysiology Group, IRBLleida, University of Lleida, Lleida, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Colàs-Compàs', 'Affiliation': 'Stroke Unit, University Hospital Arnau de Vilanova, Clinical Neurosciences Group, IRBLleida, University of Lleida, Lleida, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Benabdelhak', 'Affiliation': 'Stroke Unit, University Hospital Arnau de Vilanova, Clinical Neurosciences Group, IRBLleida, University of Lleida, Lleida, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Miquel', 'Affiliation': 'Borges Blanques Primary Health Care Unit, Borges Blanques, Lleida, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ortega', 'Affiliation': 'Borges Blanques Primary Health Care Unit, Borges Blanques, Lleida, Spain.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Valdivielso', 'Affiliation': 'Unit for the Detection and Treatment of Atherothrombotic Diseases (UDETMA V&R), University Hospital Arnau de Vilanova, Vascular and Renal Translational Research Group, IRBLleida, University of Lleida, Lleida, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bermúdez', 'Affiliation': 'Unit for the Detection and Treatment of Atherothrombotic Diseases (UDETMA V&R), University Hospital Arnau de Vilanova, Vascular and Renal Translational Research Group, IRBLleida, University of Lleida, Lleida, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Martínez-Alonso', 'Affiliation': 'Unit for the Detection and Treatment of Atherothrombotic Diseases (UDETMA V&R), University Hospital Arnau de Vilanova, Vascular and Renal Translational Research Group, IRBLleida, University of Lleida, Lleida, Spain.'}]",Diabetes & metabolism,['10.1016/j.diabet.2018.04.002']
2618,32431757,Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer.,"Background


Lung cancer screening and tobacco treatment for patients at high-risk for lung cancer may greatly reduce mortality from smoking, and there is an urgent need to improve smoking cessation therapies for this population.
Aims


The purpose of this study is to test the efficacy of two separate, sequential interventions to promote tobacco cessation/reduction compared to standard care in smokers considered high-risk for lung cancer.
Methods


The study will recruit 276 current smokers attending a lung cancer screening clinic or considered high-risk for lung cancer based on age and smoking history across two sites. Patients first will be randomized to either standard tobacco treatment (8 weeks of nicotine patch and five individual counselling sessions) or standard tobacco treatment plus personalized gain-framed messaging. At the 8-week visit, all patients will be re-randomized to receive biomarker feedback or no biomarker feedback. Repeated assessments during treatment will be used to evaluate changes in novel biomarkers: skin carotenoids, lung function, and plasma bilirubin that will be used for biomarker feedback. We hypothesize that personalized gain-framed messages and receiving biomarker feedback related to tobacco cessation/reduction will improve quit rates and prevent relapse compared to standard care. Primary outcomes include 7-day point-prevalence abstinence verified with expired carbon monoxide at 8 weeks and mean cigarettes per day in the past week at 6 months.
Conclusions


Study findings will inform the development of novel interventions for patients at risk for lung cancer to improve smoking cessation rates.",2018,We hypothesize that personalized gain-framed messages and receiving biomarker feedback related to tobacco cessation/reduction will improve quit rates and prevent relapse compared to standard care.,"['276 current smokers attending a lung cancer screening clinic or considered high-risk for lung cancer based on age and smoking history across two sites', 'patients at risk for lung cancer', 'patients at high-risk for lung cancer', 'smokers considered high-risk for lung cancer', 'Patients at Risk for Lung Cancer']","['biomarker feedback or no biomarker feedback', 'Personalized Intervention Program', 'Tobacco Treatment', 'standard tobacco treatment (8 weeks of nicotine patch and five individual counselling sessions) or standard tobacco treatment plus personalized gain-framed messaging', '\n\n\nLung cancer screening and tobacco treatment']","['7-day point-prevalence abstinence verified with expired carbon monoxide at 8 weeks and mean cigarettes per day in the past week at 6 months', 'quit rates']","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",276.0,0.0305003,We hypothesize that personalized gain-framed messages and receiving biomarker feedback related to tobacco cessation/reduction will improve quit rates and prevent relapse compared to standard care.,"[{'ForeName': 'Krysten W', 'Initials': 'KW', 'LastName': 'Bold', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Toll', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Cartmel', 'Affiliation': 'Yale School of Public Health, New Haven, CT.'}, {'ForeName': 'Bennie B', 'Initials': 'BB', 'LastName': 'Ford', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Alana M', 'Initials': 'AM', 'LastName': 'Rojewski', 'Affiliation': 'Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Fucito', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}]",Journal of smoking cessation,['10.1017/jsc.2017.24']
2619,19292750,Supplementary feeding with fortified spread among moderately underweight 6-18-month-old rural Malawian children.,"We aimed to analyse growth and recovery from undernutrition among moderately underweight ambulatory children receiving micronutrient-fortified maize-soy flour (Likuni Phala, LP) or ready-to-use fortified spread (FS) supplementary diet. One hundred and seventy-six 6-18-month-old individuals were randomized to receive 500 g LP or 350 g FS weekly for 12 weeks. Baseline and end of intervention measurements were used to calculate anthropometric gains and recovery from underweight, wasting and stunting. Mean weight-for-age increased by 0.22 (95% CI 0.07-0.37) and 0.28 (0.18-0.40) Z-score units in the LP and FS groups respectively. Comparable increase for mean weight-for-length was 0.39 (0.20-0.57) and 0.52 (0.38-0.65) Z-score units. Recovery from underweight and wasting was 20% and 93% in LP group and 16% and 75% in FS group. Few individuals recovered from stunting and mean length-for-age was not markedly changed. There were no statistically significant differences between the outcomes in the two intervention groups. In a poor food-security setting, underweight infants and children receiving supplementary feeding for 12 weeks with ready-to-use FS or maize-soy flour porridge show similar recovery from moderate wasting and underweight. Neither intervention, if limited to a 12-week duration, appears to have significant impact on the process of linear growth or stunting.",2009,"Neither intervention, if limited to a 12-week duration, appears to have significant impact on the process of linear growth or stunting.","['One hundred and seventy-six 6-18-month-old individuals', 'moderately underweight ambulatory children receiving', 'moderately underweight 6-18-month-old rural Malawian children']","['micronutrient-fortified maize-soy flour (Likuni Phala, LP) or ready-to-use fortified spread (FS) supplementary diet']","['Mean weight-for-age', 'mean weight-for-length', 'anthropometric gains and recovery from underweight, wasting and stunting']","[{'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0771806', 'cui_str': 'Soya flour (substance)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}]",,0.0396789,"Neither intervention, if limited to a 12-week duration, appears to have significant impact on the process of linear growth or stunting.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Phuka', 'Affiliation': 'College of Medicine, University of Malawi, P/Bag 360 Blantyre, Malawi. johnphuka@malawi.net'}, {'ForeName': 'Chrissie', 'Initials': 'C', 'LastName': 'Thakwalakwa', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': ''}, {'ForeName': 'Yin Bun', 'Initials': 'YB', 'LastName': 'Cheung', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Briend', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Manary', 'Affiliation': ''}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2008.00162.x']
2620,30528313,Cardio-respiratory fitness is associated with a verbal factor across cognitive domains in schizophrenia.,"OBJECTIVE


We investigated whether the relationship between cardio-respiratory fitness (CRF) and cognition in schizophrenia is general, or due to selective relationships between CRF and specific aspects of cognitive function.
METHOD


Eighty outpatients with schizophrenia spectrum disorders participated. Neurocognition was assessed with the Wechsler Adult Intelligence Scale version 4 General Ability Index (WAIS GAI), the MATRICS Consensus Cognitive Battery (MCCB) and the Emotion in Biological Motion (EBM) test. CRF was assessed with peak oxygen uptake measured directly during maximum exercise using a modified Balke protocol. Partial correlations, controlling for sex and age, were obtained for the perceptual and the verbal indices of WAIS GAI, six cognitive domains of MCCB, and the EBM total score. A factor analysis was conducted on all 15 subtests of the WAIS GAI and the MCCB, and the factors were subjected to separate regression analyses with CRF as predictor.
RESULTS


Significant, moderately sized correlations were found between CRF and all cognitive domains except processing speed. The correlation appeared strongest for CRF and the Verbal Comprehension Index of WAIS GAI (r = 0.29, p = .005). The factor analysis identified three factors: one speed/attention/executive function factor, one verbal factor, and one perceptual factor. Regression analyses showed that VO 2peak  explained a significant amount of variance in the verbal factor only (R 2  = 0.06, β = 0.329, p = .03).
CONCLUSION


The results indicate that the relationship between CRF and cognition in schizophrenia is selectively tied to a modality-specific association with verbal cognitive abilities. These findings have implications for understanding the relation between cognitive factors and physical health in schizophrenia. ClinicalTrials.gov reg. number NCT02205684 (clinicaltrials.gov/ct2/show/NCT02205684).",2019,"Partial correlations, controlling for sex and age, were obtained for the perceptual and the verbal indices of WAIS GAI, six cognitive domains of MCCB, and the EBM total score.",['Eighty outpatients with schizophrenia spectrum disorders participated'],[],"['peak oxygen uptake', 'verbal indices of WAIS GAI, six cognitive domains of MCCB, and the EBM total score', 'Wechsler Adult Intelligence Scale version 4 General Ability Index (WAIS GAI), the MATRICS Consensus Cognitive Battery (MCCB) and the Emotion in Biological Motion (EBM) test', 'CRF and the Verbal Comprehension Index of WAIS GAI', 'speed/attention/executive function factor, one verbal factor, and one perceptual factor']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0204456', 'cui_str': 'Wechsler adult intelligence scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",80.0,0.0283174,"Partial correlations, controlling for sex and age, were obtained for the perceptual and the verbal indices of WAIS GAI, six cognitive domains of MCCB, and the EBM total score.","[{'ForeName': 'Tom Langerud', 'Initials': 'TL', 'LastName': 'Holmen', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Tønsberg, Norway. Electronic address: lantom@siv.no.'}, {'ForeName': 'John Abel', 'Initials': 'JA', 'LastName': 'Engh', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Andersen', 'Affiliation': 'Faculty of Humanities, Sports and Educational Science, University College of Southeast Norway, Norway.'}, {'ForeName': 'Ole Andreas', 'Initials': 'OA', 'LastName': 'Andreassen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Egil Wilhelm', 'Initials': 'EW', 'LastName': 'Martinsen', 'Affiliation': 'Department of Research, Division of Mental Health and Addiction, Oslo University Hospital, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Therese Torgersen', 'Initials': 'TT', 'LastName': 'Bigseth', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Gry', 'Initials': 'G', 'LastName': 'Bang-Kittilsen', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Egeland', 'Affiliation': 'Division of Mental Health and Addiction, Vestfold Hospital Trust, Tønsberg, Norway; Department of Psychology, University of Oslo, Oslo, Norway.'}]",Schizophrenia research,['10.1016/j.schres.2018.11.033']
2621,32431856,Does repeatedly viewing overweight versus underweight images change perception of and satisfaction with own body size?,"Body dissatisfaction is associated with subsequent eating disorders and weight gain. One-off exposure to bodies of different sizes changes perception of others' bodies, and perception of and satisfaction with own body size. The effect of repeated exposure to bodies of different sizes has not been assessed. We randomized women into three groups, and they spent 5 min twice a day for a week completing a one-back task using images of women modified to appear either under, over, or neither over- nor underweight. We tested the effects on their perception of their own and others' body size, and satisfaction with own size. Measures at follow-up were compared between groups, adjusted for baseline measurements. In 93 women aged 18-30 years, images of other women were perceived as larger following exposure to underweight women (and vice versa) ( p  < 0.001). There was no evidence for a difference in our primary outcome measure (visual analogue scale own size) or in satisfaction with own size. Avatar-constructed ideal ( p  = 0.03) and avatar-constructed perceived own body size ( p  = 0.007) both decreased following exposure to underweight women, possibly due to adaptation affecting how the avatar was perceived. Repeated exposure to different sized bodies changes perception of the size of others' bodies, but we did not find evidence that it changes perceived own size.",2020,"In 93 women aged 18-30 years, images of other women were perceived as larger following exposure to underweight women (and vice versa) ( p  < 0.001).",['93 women aged 18-30 years'],[],['visual analogue scale own size) or in satisfaction with own size'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",93.0,0.0645557,"In 93 women aged 18-30 years, images of other women were perceived as larger following exposure to underweight women (and vice versa) ( p  < 0.001).","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bould', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, University of Bristol, Oakfield House, Oakfield Grove, Bristol BS8 2BN, UK.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Noonan', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Warneford Lane, Oxford OX3 7JX, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Penton-Voak', 'Affiliation': 'MRC Integrative Epidemiology Unit, University of Bristol, Oakfield House, Oakfield Grove, Bristol BS8 2BN, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Skinner', 'Affiliation': 'MRC Integrative Epidemiology Unit, University of Bristol, Oakfield House, Oakfield Grove, Bristol BS8 2BN, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, School of Psychological Science, University of Bristol, 12a Priory Road, Clifton, Bristol BS8 1TU, UK.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Warneford Lane, Oxford OX3 7JX, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Broome', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Warneford Lane, Oxford OX3 7JX, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Warneford Lane, Oxford OX3 7JX, UK.'}]",Royal Society open science,['10.1098/rsos.190704']
2622,19358929,A Mediterranean dietary intervention in healthy American women changes plasma carotenoids and fatty acids in distinct clusters.,"This study examined patterns of changes in plasma fatty acids and carotenoids when women were asked to follow a novel, Greek-Mediterranean exchange list diet. A total of 69 healthy, nonobese women ages 25 to 59 years were randomized either to continue their own usual diet or to follow a modified Mediterranean diet for 6 months. There were no significant changes in blood lipids, triacylglycerol, insulin, glucose, or C-reactive protein. Mean plasma carotenoids increased by 55%, which is consistent with a large increase in fruit and vegetable consumption. Likewise, changes in fat intakes were reflected in blood fatty acids, with a 25% increase in mean plasma monounsaturated fatty acids. Principal component analysis was conducted to examine the sources of interindividual variation for changes in carotenoid and fatty acid levels. Changes in the Mediterranean diet were clustered together in 4 components that accounted for 78% of the variance in plasma levels. Increases in plasma lutein, alpha-carotene, and beta-carotene clustered together in a ""vegetable"" pattern, and increases in carotenoids found in fruit, beta-cryptoxanthin and zeaxanthin also clustered together but accounted for less of the variance. Increases in plasma monounsaturated fatty acids were clustered with a decrease in plasma polyunsaturated fatty acids, consistent with substitution in the type of oils consumed. The only association of fatty acid levels with carotenoids was that of lycopene, which clustered together with an increase in saturated fatty acids. The changes in blood levels indicate the exchange list diet was effective for targeting Mediterranean nutrient intakes using foods available in the United States.",2009,"There were no significant changes in blood lipids, triacylglycerol, insulin, glucose, or C-reactive protein.","['69 healthy, nonobese women ages 25 to 59 years', 'healthy American women changes']","['continue their own usual diet or to follow a modified Mediterranean diet', 'Mediterranean dietary intervention']","['Mean plasma carotenoids', 'saturated fatty acids', 'blood fatty acids', 'fat intakes', 'blood lipids, triacylglycerol, insulin, glucose, or C-reactive protein', 'plasma lutein, alpha-carotene, and beta-carotene', 'mean plasma monounsaturated fatty acids', 'plasma polyunsaturated fatty acids', 'plasma carotenoids and fatty acids', 'plasma levels', 'blood levels', 'fruit and vegetable consumption']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0005768'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0051336', 'cui_str': 'alpha-carotene'}, {'cui': 'C0053396', 'cui_str': 'betacarotene'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",69.0,0.0165552,"There were no significant changes in blood lipids, triacylglycerol, insulin, glucose, or C-reactive protein.","[{'ForeName': 'Zora', 'Initials': 'Z', 'LastName': 'Djuric', 'Affiliation': 'Department of Family Medicine, University of Michigan, Cancer and Geriatrics Center, Ann Arbor, MI 48109-5930, USA. zoralong@umich.edu'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Blythe', 'Affiliation': ''}, {'ForeName': 'Glee', 'Initials': 'G', 'LastName': 'VanLoon', 'Affiliation': ''}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': ''}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2009.03.001']
2623,32330613,Comparison of Radiation Exposure Among 3 Different Endoscopic Diskectomy Techniques for Lumbar Disk Herniation.,"BACKGROUND


Lumbar disk herniation can be successfully treated by lumbar endoscopic spinal procedures. However, one of the most important disadvantages of the endoscopic methods used is radiation exposure. There are multiple endoscopic spinal procedures and this study aims to compare unilateral biportal endoscopic diskectomy (UBED), percutaneous endoscopic lumbar diskectomy (PELD), and microendoscopic diskectomy (MED) methods in terms of radiation exposure.
METHODS


A total of 75 people were included in this prospective and multicenter study. The demographic characteristics, operating times (minutes), levels of surgery, lumbar disk herniation types, radiation exposures (dose area product [DAP]), and fluoroscopy times (seconds) of the groups were compared.
RESULTS


Mean DAP values were 1.39 Gy·cm 2  in the UBED group, 2.46 Gy·cm 2  in the PELD group, and 1.01 Gy·cm 2  in the MED group. The UBED group had no statistically significant difference with the MED and PELD groups in terms of DAP (P = 0.281 and P = 0.058, respectively), whereas the PELD group had statistically significantly higher DAP values than the MED group (P = 0.016). The maximum mean duration of fluoroscopy usage time was 34.9 seconds in the PELD group, 19.3 seconds in the UBED group, and 4.6 seconds in the MED group. The differences between the groups were significant (P ≤ 0.001).
CONCLUSIONS


The more the level of invasiveness is reduced in spinal surgery, the greater the exposure to radiation. In this study, the groups are listed as PELD > UBED > MED according to the duration and level of radiation exposure.",2020,"Mean DAP values were 1.39 Gy·cm 2  in the UBED group, 2.46 Gy·cm 2  in the PELD group, and 1.01 Gy·cm 2  in the MED group.","['Lumbar Disk Herniation', 'A total of 75 people']","['unilateral biportal endoscopic diskectomy (UBED), percutaneous endoscopic lumbar diskectomy (PELD), and microendoscopic diskectomy (MED']","['maximum mean duration of fluoroscopy usage time', 'level of invasiveness', 'Mean DAP values', 'demographic characteristics, operating times (minutes), levels of surgery, lumbar disk herniation types, radiation exposures (dose area product [DAP]), and fluoroscopy times (seconds', 'DAP values']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301757', 'cui_str': 'Invasiveness'}, {'cui': 'C0045587', 'cui_str': '2,6-diaminopurine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",75.0,0.0289979,"Mean DAP values were 1.39 Gy·cm 2  in the UBED group, 2.46 Gy·cm 2  in the PELD group, and 1.01 Gy·cm 2  in the MED group.","[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Merter', 'Affiliation': 'Department of Orthopedics, Spine Section, School of Medicine, Ibn-i Sina Hospital, Ankara University, Ankara, Turkey. Electronic address: dr.merter@gmail.com.'}, {'ForeName': 'Oguz', 'Initials': 'O', 'LastName': 'Karaeminogullari', 'Affiliation': 'Department of Orthopedics, Spine Section, Bayindir Sogutozu Hospital, Ankara, Turkey.'}, {'ForeName': 'Motohide', 'Initials': 'M', 'LastName': 'Shibayama', 'Affiliation': 'Department of Orthopedics, Spine Section, Aichi Spine Hospital, Aichi Prefecture, Japan.'}]",World neurosurgery,['10.1016/j.wneu.2020.04.079']
2624,30755718,Tidal volume transmission during non-synchronized nasal intermittent positive pressure ventilation via RAM ®  cannula.,"BACKGROUND


Nasal intermittent positive pressure ventilation (NIPPV) is a widely used mode of support in neonates, during which ventilator inflations may or may not coincide with spontaneous breathing.
OBJECTIVE


We tested the hypothesis that inflations delivered with NIPPV via RAM ®  cannula and not accompanied by patient effort produce minimal tidal volume as measured by respiratory inductance plethysmography.
DESIGN/METHODS


Fourteen subjects were monitored while receiving NIPPV. We compared tidal volumes during ventilator-supported breaths, unsupported breaths, and ventilator inflations not accompanied by patient effort (defined using electrical activity of the diaphragm).
RESULTS


Mean tidal volumes in arbitrary units were 0.30 ± 0.22 in NIPPV inflations associated with patient effort and 0.27 ± 0.15 in spontaneous breaths without ventilator assistance (p = 0.82). Tidal volumes during ventilator-only inflations were 0.06 ± 0.04 (p < 0.005 vs. both ventilator-assisted and unassisted efforts).
CONCLUSIONS


NIPPV via RAM cannula produces minimal, clinically insignificant tidal volumes during non-spontaneous inflations.",2019,"Tidal volumes during ventilator-only inflations were 0.06 ± 0.04 (p < 0.005 vs. both ventilator-assisted and unassisted efforts).
",['Fourteen subjects were monitored while receiving NIPPV'],"['synchronized nasal intermittent positive pressure ventilation via RAM ®  cannula', 'NIPPV via RAM ®  cannula', 'Nasal intermittent positive pressure ventilation (NIPPV', 'NIPPV via RAM cannula']","['tidal volumes', 'Tidal volumes', 'Mean tidal volumes', 'Tidal volume transmission']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0526951', 'cui_str': 'ramosetron hydrochloride'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040722', 'cui_str': 'transmission'}]",14.0,0.053567,"Tidal volumes during ventilator-only inflations were 0.06 ± 0.04 (p < 0.005 vs. both ventilator-assisted and unassisted efforts).
","[{'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Matlock', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 W. Markham Street, Slot 512-5B, Little Rock, AR, 72205, USA. DMatlock@uams.edu.'}, {'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': 'Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Weisner', 'Affiliation': 'Equilibrated Bio Systems, Inc., Smithtown, NY, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Comtois', 'Affiliation': ""Keenan Research Centre for Biomedical Science, St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Beck', 'Affiliation': ""Keenan Research Centre for Biomedical Science, St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Sinderby', 'Affiliation': ""Keenan Research Centre for Biomedical Science, St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Sherry E', 'Initials': 'SE', 'LastName': 'Courtney', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0333-x']
2625,32431967,"Hemodynamic Stability, Patient Acceptance and Cost of Intravenous Propofol and Inhalational Sevoflurane for Induction of Anaesthesia: A Prospective, Randomized Comparative Study.","Introduction The effects of an anesthetic agent on the hemodynamic stability are of prime importance in patients with compromised hemodynamics. Although comparative studies of sevoflurane and propofol are reported, most of these are aimed to assess maintenance and early postoperative recovery. There are very few studies on hemodynamic changes occurring with these two agents. This study compares the hemodynamic stability, patient acceptance, and cost of intravenous (IV) propofol versus inhalational (IH) sevoflurane for the induction of anesthesia. Methods This prospective, randomized comparative study was conducted among 80 patients with American Society of Anaesthesiologists (ASA) grade-I requiring general anesthesia (GA) for elective surgical procedures. The study was approved by the institutional ethics committee and was conducted as per the principles of the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. Enrolled patients were randomized to receive either intravenous (IV) propofol 2 mg/kg (n=40) or gradual inhalational (IH) induction with sevoflurane (n=40). All patients were maintained with sevoflurane 2% in 67% nitrous oxide (N 2 O) and O 2 . Hemodynamic parameters like pulse rate and mean arterial pressure (MAP) were monitored every minute up to five minutes. Patients' acceptance was assessed on a 10-item questionnaire, and the cost of anesthesia was assessed based on the anesthetic requirement. The hemodynamic parameters were compared between the two groups using two-way repeat-measures ANOVA. The incidence of hypotension was compared using Fischer's test.  Results The two groups were similar at baseline with respect to the demography and other baseline characteristics. There was greater (p<0.05) fall in MAP with propofol induction (28.48%) compared to sevoflurane (14.61%). Greater reduction in pulse rate (p<0.05) with sevoflurane (9.18) induction was observed compared to propofol (5.28). Patient acceptance for both drugs was similar (p>0.05). Although sevoflurane was unpleasant, propofol injection was painful. Ninety percent of patients preferred propofol for repeat anesthesia as against 85% of patients with sevoflurane. Considering the quantity of anesthetic consumed and the unit cost, propofol was more costly as compared to sevoflurane. Conclusion Sevoflurane maintains better hemodynamic stability compared to propofol, and patient acceptance of both drugs is similar. Induction with sevoflurane was found to be cheaper as compared to propofol induction.",2020,Greater reduction in pulse rate (p<0.05) with sevoflurane (9.18) induction was observed compared to propofol (5.28).,"['patients with compromised hemodynamics', '80 patients with American Society of Anaesthesiologists (ASA) grade', 'Anaesthesia']","['intravenous (IV) propofol 2 mg/kg (n=40) or gradual inhalational (IH) induction with sevoflurane', 'nitrous oxide', 'Propofol and Inhalational Sevoflurane', 'intravenous (IV) propofol versus inhalational (IH) sevoflurane', 'sevoflurane and propofol', 'general anesthesia (GA', 'sevoflurane', 'propofol', 'Sevoflurane']","['Hemodynamic Stability, Patient Acceptance and Cost', 'hemodynamic stability', 'pulse rate', 'incidence of hypotension', 'Hemodynamic parameters like pulse rate and\xa0mean arterial pressure (MAP', 'hemodynamic parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0412768', 'cui_str': 'Inhalational induction'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",80.0,0.0235631,Greater reduction in pulse rate (p<0.05) with sevoflurane (9.18) induction was observed compared to propofol (5.28).,"[{'ForeName': 'Kirtibala', 'Initials': 'K', 'LastName': 'Dhande', 'Affiliation': 'Anesthesiology, DY Patil Hospital, Navi Mumbai, IND.'}, {'ForeName': 'Jitendra', 'Initials': 'J', 'LastName': 'Kshirsagar', 'Affiliation': 'Anesthesiology, Deenanath Mangeshkar Hospital, Pune, IND.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Dhande', 'Affiliation': 'Urology, DY Patil University - School of Medicine, Navi Mumbai, IND.'}, {'ForeName': 'Narendra', 'Initials': 'N', 'LastName': 'Patil', 'Affiliation': 'Anesthesiology, DY Patil University - School of Medicine, Navi Mumbai, IND.'}, {'ForeName': 'Parvati', 'Initials': 'P', 'LastName': 'V', 'Affiliation': 'Anesthesiology, DY Patil University - School of Medicine, Navi Mumbai, IND.'}]",Cureus,['10.7759/cureus.7687']
2626,32430524,Donor wound satisfaction after living-donor liver transplantation in the era of pure laparoscopic donor hepatectomy.,"BACKGROUND


Donor safety and cosmetic outcome are the main concerns raised by most living-donors. Pure laparoscopic living-donor hepatectomy (PLLDH) can provide the balance between those concerns. No studies evaluated the donors' satisfaction after PLLDH. The aim of this study is to evaluate the donors' satisfaction after PLLDH compared with donors who underwent open approach.
METHODS


We randomly assigned a questionnaire (Donor satisfaction questionnaire) to the donors, operated between 2011 and 2017, during their follow-up visits in the outpatient clinic. Donors who responded to the questionnaire were included in our study. Donors were divided into 3 groups: L group (conventional inverted L incision), M group (midline incision), and PL group (laparoscopic approach).
RESULTS


149 donors were included in our study. L group included 60 donors (40.3%), M group included 39 patients (26.2%), and PL group included 50 patients (33.5%). There were no significant differences between the groups regarding preoperative and perioperative outcomes apart from shorter operation time in PL group and higher wound infection in M group. Body image scale was significantly better in PL group (p = 0.001). Cosmetic scale was significantly higher in PL group (p = 0.001). Regarding self-confidence scale, it was significantly higher in PL group (p = 0.001). There was no significant difference between the groups regarding the sense of dullness or numbness on the scar (p = 0.113).
CONCLUSION


PLLDH is safe and feasible for living-donor hepatectomy. Donors operated by pure laparoscopic approach have better satisfaction scores compared to conventional open approach.",2020,There were no significant differences between the groups regarding preoperative and perioperative outcomes apart from shorter operation time in PL group and higher wound infection in M group.,"['Donors who responded to the questionnaire were included in our study', '149 donors were included in our study']","['living-donor liver transplantation', 'Pure laparoscopic living-donor hepatectomy (PLLDH', 'PLLDH', 'pure laparoscopic donor hepatectomy', 'L group (conventional inverted L incision), M group (midline incision), and PL group (laparoscopic approach']","['wound infection', 'satisfaction scores', 'Body image scale', 'sense of dullness or numbness on the scar', 'Cosmetic scale']","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C5191071', 'cui_str': '149'}]","[{'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0411259', 'cui_str': 'Removal of liver from donor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4522321', 'cui_str': 'Inverted'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0456276', 'cui_str': 'Midline incision'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}]",149.0,0.0424246,There were no significant differences between the groups regarding preoperative and perioperative outcomes apart from shorter operation time in PL group and higher wound infection in M group.,"[{'ForeName': 'Jeong-Moo', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, 28 Yongon-Dong, Chongno-gu, Seoul, 110-744, Korea.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shehta', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, 28 Yongon-Dong, Chongno-gu, Seoul, 110-744, Korea.'}, {'ForeName': 'Kwang-Woong', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, 28 Yongon-Dong, Chongno-gu, Seoul, 110-744, Korea. kwleegs@gmail.com.'}, {'ForeName': 'Suk Kyun', 'Initials': 'SK', 'LastName': 'Hong', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, 28 Yongon-Dong, Chongno-gu, Seoul, 110-744, Korea.'}, {'ForeName': 'Jae-Hyung', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, 28 Yongon-Dong, Chongno-gu, Seoul, 110-744, Korea.'}, {'ForeName': 'Nam-Joon', 'Initials': 'NJ', 'LastName': 'Yi', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, 28 Yongon-Dong, Chongno-gu, Seoul, 110-744, Korea.'}, {'ForeName': 'Kyung-Suk', 'Initials': 'KS', 'LastName': 'Suh', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, 28 Yongon-Dong, Chongno-gu, Seoul, 110-744, Korea.'}]",Surgical endoscopy,['10.1007/s00464-020-07640-2']
2627,32430557,Engaging Community Networks to Improve Depression Services: A Cluster-Randomized Trial of a Community Engagement and Planning Intervention.,"This paper explores the effects of a group-randomized controlled trial, Community Partners in Care (CPIC), on the development of interagency networks for collaborative depression care improvement between a community engagement and planning (CEP) intervention and a resources for services (RS) intervention that provided the same content solely via technical assistance to individual programs. Both interventions consisted of a diverse set of service agencies, including health, mental health, substance abuse treatment, social services, and community-trusted organizations such as churches and parks and recreation centers. Participants in the community councils for the CEP intervention reflected a range of agency leaders, staff, and other stakeholders. Network analysis of partnerships among agencies in the CEP versus RS condition, and qualitative analysis of perspectives on interagency network changes from multiple sources, suggested that agencies in the CEP intervention exhibited greater growth in partnership capacity among themselves than did RS agencies. CEP participants also viewed the coalition development intervention both as promoting collaboration in depression services and as a meaningful community capacity building activity. These descriptive results help to identify plausible mechanisms of action for the CPIC interventions and can be used to guide development of future community engagement interventions and evaluations in under-resourced communities.",2020,"Both interventions consisted of a diverse set of service agencies, including health, mental health, substance abuse treatment, social services, and community-trusted organizations such as churches and parks and recreation centers.","['Community Partners in Care (CPIC', 'Depression Services', 'Participants in the community councils for the CEP intervention reflected a range of agency leaders, staff, and other stakeholders']","['CEP', 'Community Engagement and Planning Intervention', 'community engagement and planning (CEP) intervention and a resources for services (RS) intervention']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],,0.0428009,"Both interventions consisted of a diverse set of service agencies, including health, mental health, substance abuse treatment, social services, and community-trusted organizations such as churches and parks and recreation centers.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mendel', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, 90407, USA. mendel@rand.org.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': ""O'Hora"", 'Affiliation': 'Center for Health Services and Society, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, USA.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Center for Health Services and Society, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stockdale', 'Affiliation': ""Greater Los Angeles Veteran's Affairs, Los Angeles, USA.""}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Dixon', 'Affiliation': 'School of Nursing, University of California, Los Angeles, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Gilmore', 'Affiliation': 'Behavioral Health Services, Gardena, CA, USA.'}, {'ForeName': 'Felica', 'Initials': 'F', 'LastName': 'Jones', 'Affiliation': 'Healthy African American Families II, Los Angeles, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Healthy African American Families II, Los Angeles, CA, USA.'}, {'ForeName': 'Pluscedia', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Healthy African American Families II, Los Angeles, CA, USA.'}, {'ForeName': 'Mienah Zulfacar', 'Initials': 'MZ', 'LastName': 'Sharif', 'Affiliation': 'Centre for Social Research and Methods, College of Arts and Social Sciences, Australian National University, Canberra, Australia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Masongsong', 'Affiliation': 'Healthy African American Families II, Los Angeles, CA, USA.'}, {'ForeName': 'Farbod', 'Initials': 'F', 'LastName': 'Kadkhoda', 'Affiliation': 'Center for Health Services and Society, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, USA.'}, {'ForeName': 'Esmeralda', 'Initials': 'E', 'LastName': 'Pulido', 'Affiliation': 'University of Washington Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'Chung', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, 90407, USA.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Wells', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, 90407, USA.'}]",Community mental health journal,['10.1007/s10597-020-00632-5']
2628,32432013,In Pursuit of the Most Effective Method of Teaching Feedback Skills to Emergency Medicine Residents in Qatar: A Mixed Design.,"Purpose The study aimed to find an effective method of teaching feedback skills to residents and to gauge their preference. Method This was a mixed design study conducted at the emergency department of a large tertiary care hospital. The residents were randomized to groups A, B, and C. Group A (control) received a traditional lecture, Group B read a specifically written brief document, and Group C received 1:1 tutoring from one faculty. Each resident individually watched a four-minute video on an emergency procedure and provided feedback in simulated settings, which was audio-recorded and rated by two blinded raters. An assessment form was created and validated. The residents' preference was attained through a semi-structured interview. Results The baseline characteristics of the three groups were similar. Compared to Group A, Groups B and C scored significantly higher on the overall assessment and were statistically similar to each other. There was no sign of association between both gender and postgraduate score (PGY) year on the total score. Residents' equally preferred self-reading and 1:1 tutoring. Conclusion The acquisition of feedback skills by emergency medicine (EM) residents was comparable between self-learning from an appropriately written document and 1:1 teaching by adequately trained faculty.",2020,"Compared to Group A, Groups B and C scored significantly higher on the overall assessment and were statistically similar to each other.","['emergency department of a large tertiary care hospital', 'Emergency Medicine Residents in Qatar']","['traditional lecture, Group B read a specifically written brief document, and Group C received 1:1 tutoring from one faculty']",[],"[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0034366', 'cui_str': 'Qatar'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}]",[],,0.0236717,"Compared to Group A, Groups B and C scored significantly higher on the overall assessment and were statistically similar to each other.","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Bashir', 'Affiliation': 'Emergency Medicine, Hamad Medical Corporation, Doha, QAT.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Elmoheen', 'Affiliation': 'Emergency Medicine, Hamad Medical Corporation, Doha, QAT.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Seif', 'Affiliation': 'Emergency Medicine, Hamad Medical Corporation, Doha, QAT.'}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Anjum', 'Affiliation': 'Emergency Medicine, Hamad Medical Corporation, Doha, QAT.'}, {'ForeName': 'Saleem', 'Initials': 'S', 'LastName': 'Farook', 'Affiliation': 'Emergency Medicine, Hamad Medical Corporation, Doha, QAT.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Emergency Medicine, Hamad Medical Corporation, Doha, QAT.'}]",Cureus,['10.7759/cureus.8155']
2629,32430540,Moderate acute alcohol use impairs intentional inhibition rather than stimulus-driven inhibition.,"Moderate alcohol intake may impair stimulus-driven inhibition of motor actions in go/no-go and stop-signal tasks. Exposure to alcohol-related cues has been found to exacerbate this impairment. By contrast, the effect of alcohol use on intentional inhibition, or the capacity to voluntarily suspend an action, has rarely been investigated. We examined whether and how moderate alcohol intake affects stimulus-driven inhibition (stop-signal task) and intentional inhibition (chasing bottles task), during exposure to alcohol-related stimuli. One hundred and eleven participants were randomly assigned to an alcohol (male: 0.55 g/kg, female: 0.45 g/kg), placebo, or control group. For the stop-signal task, ANOVAs were performed on stop-signal reaction time (SSRT) and go RT with Pharmacological and Expectancy Effects of Alcohol, Stimulus Category (alcohol-related or neutral), and Sex as factors. For the chasing bottles task, multilevel survival analysis was performed to predict whether and when intentional inhibition was initiated, with the same factors. For the stop-signal task, Sex moderated the Pharmacological Effect of Alcohol on SSRT: only for females, alcohol consumption shortened SSRT. In the non-alcohol groups, males had shorter SSRT than females. Concerning intentional inhibition, the alcohol group initiated intentional inhibition less often, especially when stimuli were non-alcohol related. These findings indicate that (1) stimulus-driven inhibition and intentional inhibition reflect different aspects of response inhibition; (2) moderate alcohol intake negatively affects intentional inhibition (but not stimulus-driven inhibition). Speculatively, the observed impairment in intentional inhibition might underlie the lack of control over alcohol drinking behavior after a priming dose. This study highlights the potential role of intentional inhibition in the development of addiction.",2020,"For the stop-signal task, Sex moderated the Pharmacological Effect of Alcohol on SSRT: only for females, alcohol consumption shortened SSRT.",['One hundred and eleven participants'],"['placebo, or control group']",[],"[{'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],111.0,0.0175839,"For the stop-signal task, Sex moderated the Pharmacological Effect of Alcohol on SSRT: only for females, alcohol consumption shortened SSRT.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands. yliux@outlook.com.'}, {'ForeName': 'Raoul P P P', 'Initials': 'RPPP', 'LastName': 'Grasman', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Reinout W', 'Initials': 'RW', 'LastName': 'Wiers', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'K Richard', 'Initials': 'KR', 'LastName': 'Ridderinkhof', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Wery P M', 'Initials': 'WPM', 'LastName': 'van den Wildenberg', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}]",Psychological research,['10.1007/s00426-020-01353-w']
2630,32430693,"A multi-camera, multi-view system for training and skill assessment for robot-assisted surgery.","PURPOSE


This paper introduces the concept of using an additional intracorporeal camera for the specific goal of training and skill assessment and explores the benefits of such an approach. This additional camera can provide an additional view of the surgical scene, and we hypothesize that this additional view would improve surgical training and skill assessment in robot-assisted surgery.
METHODS


We developed a multi-camera, multi-view system, and we conducted two user studies ([Formula: see text]) to evaluate its effectiveness for training and skill assessment. In the training user study, subjects were divided into two groups: a single-view group and a dual-view group. The skill assessment study was a within-subject study, in which every subject was shown single- and dual view recorded videos of a surgical training task, and the goal was to count the number of errors committed in each video.
RESULTS


The results show the effectiveness of using an additional intracorporeal camera view for training and skill assessment. The benefits of this view are modest for skill assessment as it improves the assessment accuracy by approximately 9%. For training, the additional camera view is clearly more effective. Indeed, the dual-view group is 57% more accurate than the single-view group in a retention test. In addition, the dual-view group is 35% more accurate and 25% faster than the single-view group in a transfer test.
CONCLUSION


A multi-camera, multi-view system has the potential to significantly improve training and moderately improve skill assessment in robot-assisted surgery. One application of our work is to include an additional camera view in existing virtual reality surgical training simulators to realize its benefits in training. The views from the additional intracorporeal camera can also be used to improve on existing surgical skill assessment criteria used in training systems for robot-assisted surgery.",2020,"A multi-camera, multi-view system has the potential to significantly improve training and moderately improve skill assessment in robot-assisted surgery.",[],['single-view group and a dual-view group'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",[],,0.0292817,"A multi-camera, multi-view system has the potential to significantly improve training and moderately improve skill assessment in robot-assisted surgery.","[{'ForeName': 'Alaa Eldin', 'Initials': 'AE', 'LastName': 'Abdelaal', 'Affiliation': 'Electrical and Computer Engineering Department, University of British Columbia, Vancouver, V6T 1Z4, Canada. aabdelaal@ece.ubc.ca.'}, {'ForeName': 'Apeksha', 'Initials': 'A', 'LastName': 'Avinash', 'Affiliation': 'Electrical and Computer Engineering Department, University of British Columbia, Vancouver, V6T 1Z4, Canada.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Kalia', 'Affiliation': 'Electrical and Computer Engineering Department, University of British Columbia, Vancouver, V6T 1Z4, Canada.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Hager', 'Affiliation': 'Department of Computer Science, Johns Hopkins University, Baltimore, MD, 21218, USA.'}, {'ForeName': 'Septimiu E', 'Initials': 'SE', 'LastName': 'Salcudean', 'Affiliation': 'Electrical and Computer Engineering Department, University of British Columbia, Vancouver, V6T 1Z4, Canada.'}]",International journal of computer assisted radiology and surgery,['10.1007/s11548-020-02176-1']
2631,32430775,"Comparison of clinical efficacy and patient acceptance of interdental brush and silicone coated interdental pick: a randomized split-mouth, prospective clinical trial.","OBJECTIVES


The aim of this split-mouth, prospective controlled study was to compare the effects of two different interdental devices on clinical plaque elimination, gingival bleeding and patient acceptance and comfort.
MATERIALS AND METHODS


Thirty participants who had been diagnosed with gingivitis were included in the study. After professional oral prophylaxis and a 3-day washout period, patients were advised to use two test devices (TePe Interdental Brushes Original and TePe EasyPick™, Malmö, Sweden) according to instructions. The plaque index (Turesky modification of the Quigley and Hein Index) and bleeding index (Papillary Bleeding Index) were recorded at baseline and after 2 weeks. Patient satisfaction and comfort were assessed with a questionnaire.
RESULTS


Both of the tested devices improved the plaque and bleeding index scores. There were no differences between the two sides in terms of time-dependent changes. The patients felt more satisfied with the cleansing capacity and more comfortable with the use of SCIP compared with IDB (p = 0.001). Pain sensation with the use of SCIP was significantly lower than with IDB (p = 0.002).
CONCLUSION


The clinical efficiency of the tested interdental devices was similar in terms of removing plaque and decreasing bleeding. However, SCIP were found to be more comfortable and preferable to IDB.
CLINICAL RELEVANCE


The silicone coated interdental picks showed similar effects on plaque removal as interdental brushes and superiority in terms of ease to use than interdental brushes.",2020,"Pain sensation with the use of SCIP was significantly lower than with IDB (p = 0.002).
",['Thirty participants who had been diagnosed with gingivitis were included in the study'],['interdental brush and silicone coated interdental pick'],"['plaque and bleeding index scores', 'clinical plaque elimination, gingival bleeding and patient acceptance and comfort', 'plaque removal', 'plaque index (Turesky modification of the Quigley and Hein Index) and bleeding index (Papillary Bleeding Index', 'Pain sensation']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442104', 'cui_str': 'Interdental'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",30.0,0.0542861,"Pain sensation with the use of SCIP was significantly lower than with IDB (p = 0.002).
","[{'ForeName': 'Gülbahar', 'Initials': 'G', 'LastName': 'Ustaoğlu', 'Affiliation': 'Department of Periodontology, Bolu Abant Izzet Baysal University, Bolu, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Ercan', 'Affiliation': 'Department of Periodontology, Çanakkale Onsekiz Mart University, Çanakkale, Turkey. esraercan82@gmail.com.'}, {'ForeName': 'Kerem Çağlar', 'Initials': 'KÇ', 'LastName': 'Gümüş', 'Affiliation': 'Department of Periodontology, Bolu Abant Izzet Baysal University, Bolu, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03293-6']
2632,32430771,Hypopharyngeal packing during adenotonsillectomy by cold dissection in children: a randomized controlled trial.,"PURPOSE


Nausea and vomiting occur in up to 70% of children after adenotonsillectomy, ingested blood during procedure being one of the reasons for emesis. Hypopharyngeal packing (HP) is a common practice among otolaryngologists to prevent blood from being swallowed, but studies in nasal surgeries in adults failed to show efficacy of this technique in reducing postoperative nausea and vomiting (PONV). There are no studies evaluating the effect of HP in adenotonsillectomy in children. The aim of this study is to evaluate the efficacy HP during adenotonsillectomy in children in the prevention of PONV.
METHODS


This is a randomized, double-blinded, controlled trial. Children aged 4-16 years, scheduled for adenotonsillectomy due to sleep-disordered breathing were enrolled in Hospital da Criança Santo Antônio (Brazil). 192 participants were screened, while 129 were enrolled and completed follow-up for primary outcome. Patients were randomized in a consecutive manner to receive HP or not during adenotonsillectomy. PONV occurrence was assessed in the first 24 h after surgery in HP and control group and relative risk with 95% confidence interval was calculated.
RESULTS


There were 129 patients randomized, 64 in the HP and 65 in the control group. Female were 40.3% and mean ± SD age was 7.3 ± 2.9. Baseline characteristics and surgery variables were distributed similarly between the groups. Incidence of PONV was 20.3% in the HP and 23.1% in the control group. The relative risk for PONV was 0.88 (95% CI 0.46-1.70).
CONCLUSION


Our results suggest that there is no benefit of HP during adenotonsillectomy in children for the prevention of PONV.
TRIAL REGISTRATION


Brazilian Register of Randomized Trials (REBEC) identifier: RBR-3zjn27; Universal Trial Number U1111-1197-7461.",2020,The relative risk for PONV was 0.88,"['children', '129 patients randomized, 64 in the HP and 65 in the control group', 'children in the prevention of PONV', '192 participants were screened, while 129 were enrolled and completed follow-up for primary outcome', 'Female were 40.3% and mean\u2009±\u2009SD age was 7.3\u2009±\u20092.9', 'Children aged 4-16\xa0years, scheduled for adenotonsillectomy due to sleep-disordered breathing were enrolled in Hospital da Criança Santo Antônio (Brazil']","['HP or not during adenotonsillectomy', 'HP', 'Hypopharyngeal packing during adenotonsillectomy by cold dissection', 'adenotonsillectomy', 'Hypopharyngeal packing (HP']","['relative risk for PONV', 'PONV occurrence', 'postoperative nausea and vomiting (PONV', 'efficacy HP', 'Incidence of PONV']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",192.0,0.550873,The relative risk for PONV was 0.88,"[{'ForeName': 'Luciana Pimentel', 'Initials': 'LP', 'LastName': 'Oppermann', 'Affiliation': 'Department of Pediatric Otolaryngology of Hospital da Criança Santo Antônio/Postgraduate Program in Pediatrics, Irmandade da Santa Casa de Misericórdia de Porto Alegre/Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil. luopp24@hotmail.com.'}, {'ForeName': 'José Faibes', 'Initials': 'JF', 'LastName': 'Lubianca Neto', 'Affiliation': 'Department of Pediatric Otolaryngology of Hospital da Criança Santo Antônio/Postgraduate Program in Pediatrics, Irmandade da Santa Casa de Misericórdia de Porto Alegre/Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Renata Loss', 'Initials': 'RL', 'LastName': 'Drummond', 'Affiliation': 'Department of Pediatric Otolaryngology of Hospital da Criança Santo Antônio, Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Sérgio Luis', 'Initials': 'SL', 'LastName': 'Amantéa', 'Affiliation': 'Department of Pediatrics of Hospital da Criança Santo Antônio/Postgraduate Program in Pediatrics, Irmandade da Santa Casa de Misericórdia de Porto Alegre/Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Mariele', 'Initials': 'M', 'LastName': 'Bressan', 'Affiliation': 'Department of Otolaryngology, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Eduardo Esteves de Alcântara Marques', 'Initials': 'EEAM', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Otolaryngology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Maira Isis Dos Santos', 'Initials': 'MIDS', 'LastName': 'Stangler', 'Affiliation': 'Department of Corporate Education in Nursing of Hospital da Criança Santo Antônio/Postgraduate Program in Pediatrics, Irmandade da Santa Casa de Misericórdia de Porto Alegre/Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06032-5']
2633,32430769,Two-level ACDF with a zero-profile stand-alone spacer compared to conventional plating: a prospective randomized single-center study.,"PURPOSE


Stand-alone zero-profile devices have already proven safety, and a reduced dysphagia rate was assumed. So far, no level-one evidence is available to prove the proposed advantages of zero-profile implants in multilevel procedures. The aim of this RCT was to compare the clinical and radiological outcome of a zero-profile spacer versus cage + plate in two-level ACDF.
METHODS


Consecutive patients with contiguous two-level cDD were randomly assigned either to the interventional group (zero-profile device) or to the control group (cage + plate). Primary endpoint of the study was the prevalence of dysphagia at 24 months. Disability, progress of adjacent segment degeneration, fusion status and loss of correction were analyzed as secondary outcome measure. Primary outcome parameter was statistically analyzed by Chi-square test.
RESULTS


Forty-one patients met inclusion criteria and were randomly assigned to the interventional and the control group. Dysphagia was frequent in either group at 3 months FU favoring interventional group (p = 0.078). At final FU, less patients of the interventional group complained about dysphagia, but the difference was not significant. No relevant differences at final FU were recorded for NPDI, loss of correction and adjacent-level degeneration. Fusion rate was slightly lower in the interventional group.
DISCUSSION


Two-level ACDF either by a stand-alone zero-profile spacer or cage + plate is safe. Using a zero-profile cage dysphagia was infrequent at 24 months, but the value did not reach statistical significance in comparison with the cage + plate. Hence, this randomized trial was not able to prove the proposed clinical superiority for dysphagia rates for zero-profile anchored spacer in two-level cDD.",2020,"Using a zero-profile cage dysphagia was infrequent at 24 months, but the value did not reach statistical significance in comparison with the cage + plate.","['Forty-one patients met inclusion criteria', 'Consecutive patients with contiguous two-level cDD']","['conventional plating', 'interventional group (zero-profile device) or to the control group (cage\u2009+\u2009plate', 'Two-level ACDF with a zero-profile stand-alone spacer', 'zero-profile spacer versus cage\u2009+\u2009plate']","['Fusion rate', 'Chi-square test', 'prevalence of dysphagia', 'Disability, progress of adjacent segment degeneration, fusion status and loss of correction', 'dysphagia rates', 'dysphagia rate', 'NPDI, loss of correction and adjacent-level degeneration', 'Dysphagia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205283', 'cui_str': 'Contiguous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0410539', 'cui_str': 'Craniodiaphyseal dysplasia'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0337189', 'cui_str': 'Cage'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}]","[{'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C3888829', 'cui_str': 'Adjacent segment degeneration'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}]",41.0,0.0501616,"Using a zero-profile cage dysphagia was infrequent at 24 months, but the value did not reach statistical significance in comparison with the cage + plate.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Scholz', 'Affiliation': 'Center for Spinal Surgery and Neurotraumatology, BG Unfallklinik Frankfurt am Main gGmbH, Friedberger Landstraße 430, 60389, Frankfurt am Main, Germany. matti.scholz@bgu-frankfurt.de.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Onal', 'Affiliation': 'Neurosurgical Department, Acıbadem University Vocational School of Health Services, Istanbul, Turkey.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schleicher', 'Affiliation': 'Center for Spinal Surgery and Neurotraumatology, BG Unfallklinik Frankfurt am Main gGmbH, Friedberger Landstraße 430, 60389, Frankfurt am Main, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pingel', 'Affiliation': 'Center for Spinal Surgery and Neurotraumatology, BG Unfallklinik Frankfurt am Main gGmbH, Friedberger Landstraße 430, 60389, Frankfurt am Main, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hoffmann', 'Affiliation': 'Center for Spinal Surgery and Neurotraumatology, BG Unfallklinik Frankfurt am Main gGmbH, Friedberger Landstraße 430, 60389, Frankfurt am Main, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kandziora', 'Affiliation': 'Center for Spinal Surgery and Neurotraumatology, BG Unfallklinik Frankfurt am Main gGmbH, Friedberger Landstraße 430, 60389, Frankfurt am Main, Germany.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-020-06454-z']
2634,32430774,Effect of treatment with a full-occlusion biofeedback splint on sleep bruxism and TMD pain: a randomized controlled clinical trial.,"OBJECTIVES


The purpose of the present study was to analyze treatment outcome with a full-occlusion biofeedback (BFB) splint on sleep bruxism (SB) and TMD pain compared with treatment with an adjusted occlusal splint (AOS).
MATERIALS AND METHODS


Forty-one patients were randomly allocated to a test (BFB) or a control (AOS) group and monitored over a 3-month period. Output variables were frequency and duration of bruxing events (bursts) and various pain symptoms.
RESULTS


The BFB group showed a statistically significant reduction in the frequency and duration of bursts and a statistically significant improvement in the patients' global well-being and the facial muscle pain parameter. After the treatment was stopped, the BFB group showed a statistically significant reduction in the average and maximum duration but no statistically significant change in the frequency of bursts.
CONCLUSIONS


The tested BFB splint is highly effective in reducing SB at the subconscious level, i.e., without waking the patient, and in achieving improvements in global pain perception. The results suggest that the BFB splint also provides a better treatment option for bruxism-related pain than an AOS. However, further research is needed, and specifically studies with a larger patient population displaying higher levels of pain at baseline.
CLINICAL RELEVANCE


By reducing burst duration and therefore the pathological load on the masticatory apparatus, the BFB splint reduces TMD and bruxism-related symptoms and improves patients' physical well-being. In the long term, this could prevent damage to the TMJ. This study confirms the effectiveness and safety of this splint.
THE UNIVERSAL TRIAL NUMBER


U1111-1239-2450 DRKS-ID REGISTRATION: DRKS00018092.",2020,"After the treatment was stopped, the BFB group showed a statistically significant reduction in the average and maximum duration but no statistically significant change in the frequency of bursts.
",['Forty-one patients'],"['BFB splint', 'adjusted occlusal splint (AOS', 'test (BFB) or a control (AOS', 'full-occlusion biofeedback splint', 'full-occlusion biofeedback (BFB) splint']","['sleep bruxism (SB) and TMD pain', 'average and maximum duration', 'frequency and duration of bruxing events (bursts) and various pain symptoms', 'sleep bruxism and TMD pain', 'frequency of bursts', ""patients' global well-being and the facial muscle pain parameter"", 'frequency and duration of bursts', 'global pain perception']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}]","[{'cui': 'C0751771', 'cui_str': 'Nocturnal Teeth Grinding Disorder'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015460', 'cui_str': 'Facial Muscles'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",41.0,0.0790369,"After the treatment was stopped, the BFB group showed a statistically significant reduction in the average and maximum duration but no statistically significant change in the frequency of bursts.
","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bergmann', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany. Alexander.Bergmann@med.uni-muenchen.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Edelhoff', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schubert', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany.'}, {'ForeName': 'Kurt-Jürgen', 'Initials': 'KJ', 'LastName': 'Erdelt', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Pho Duc', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03270-z']
2635,32432123,"Shorter Total Length of Stay After Intraperitoneal Fosfomycin, Metronidazole, and Molgramostim for Complicated Appendicitis: A Pivotal Quasi-Randomized Controlled Trial.","Background:  We aimed to investigate the difference in the total length of hospital stay (LOS) after intraperitoneal vs. intravenous antibiotic treatment in patients with complicated appendicitis.  Methods:  We conducted a quasi-randomized prospective clinical trial. The intervention group received 4 g fosfomycin, 1 g metronidazole, and 50 μg recombinant human granulocyte-macrophage colony-stimulating factor intraperitoneally, which was left in the abdominal cavity, immediately after laparoscopic appendectomy. Postoperatively, this group received antibiotics orally. The control group received intravenous antibiotics both during surgery and postoperatively. We primarily evaluated total LOS within 30 days. Furthermore, we evaluated harms and adverse events, Gastrointestinal Quality of Life Index, postoperative complications, and convalescence. Participants were followed for 30 days postoperatively.  Results:  A total of 12 participants concluded the trial. The total LOS was significantly shorter in the intervention group (six participants, median 13 h; range 2-21 h) than in the control group (six participants, median 84 h; range 67-169 h),  p  = 0.017. Comparable harms and Gastrointestinal Quality of Life Index scores were found in the two groups. The time to return to normal activities was median 6 and 10 days for the intervention and the control group, respectively. There were no serious adverse events related to the trial nor any complications in the intervention group. In the control group, two patients developed intraabdominal abscesses.  Conclusions:  The intervention group had a significantly shorter total LOS. The study was not powered to assess differences in complications, but the results indicate that the intervention seems to be a safe regimen, which can be investigated further to treat patients with complicated appendicitis.  Identifiers:  EudraCT no. 2017-004753-16.  ClinicalTrials:  https://clinicaltrials.gov/ct2/show/NCT03435900?term=NCT03435900&draw=2&rank=1"">draw=2&rank=1.",2020,"The total LOS was significantly shorter in the intervention group (six participants, median 13 h; range 2-21 h) than in the control group (six participants, median 84 h; range 67-169 h),  p  = 0.017.","['Complicated Appendicitis', 'patients with complicated appendicitis']","['intravenous antibiotics', '4 g fosfomycin, 1 g metronidazole, and 50 μg recombinant human granulocyte-macrophage colony-stimulating factor intraperitoneally', 'Intraperitoneal Fosfomycin, Metronidazole, and Molgramostim', 'EudraCT', 'intraperitoneal vs. intravenous antibiotic treatment', 'antibiotics orally']","['shorter total LOS', 'Shorter Total Length of Stay', 'harms and adverse events, Gastrointestinal Quality of Life Index, postoperative complications, and convalescence', 'time to return to normal activities', 'intraabdominal abscesses', 'Comparable harms and Gastrointestinal Quality of Life Index scores', 'serious adverse events', 'total length of hospital stay (LOS', 'total LOS']","[{'cui': 'C1632842', 'cui_str': 'Complicated appendicitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0218633', 'cui_str': 'molgramostim'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0009940', 'cui_str': 'Convalescence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0230168', 'cui_str': 'Abdominopelvic cavity structure'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",12.0,0.103086,"The total LOS was significantly shorter in the intervention group (six participants, median 13 h; range 2-21 h) than in the control group (six participants, median 84 h; range 67-169 h),  p  = 0.017.","[{'ForeName': 'Siv', 'Initials': 'S', 'LastName': 'Fonnes', 'Affiliation': 'Department of Surgery, Centre for Perioperative Optimisation, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Roepstorff', 'Affiliation': 'Digestive Disease Centre, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Barbara Juliane', 'Initials': 'BJ', 'LastName': 'Holzknecht', 'Affiliation': 'Department of Clinical Microbiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Christoffer Skov', 'Initials': 'CS', 'LastName': 'Olesen', 'Affiliation': 'Department of Surgery, Centre for Perioperative Optimisation, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Joachim Hjalde Halmsted', 'Initials': 'JHH', 'LastName': 'Olsen', 'Affiliation': 'Department of Surgery, Centre for Perioperative Optimisation, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Schmidt', 'Affiliation': 'Department of Surgery, Centre for Perioperative Optimisation, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Alder', 'Affiliation': 'Department of Surgery, Centre for Perioperative Optimisation, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gamborg', 'Affiliation': 'Department of Surgery, Centre for Perioperative Optimisation, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Tilde', 'Initials': 'T', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Surgery, Centre for Perioperative Optimisation, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Arpi', 'Affiliation': 'Department of Clinical Microbiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Lars Nannestad', 'Initials': 'LN', 'LastName': 'Jørgensen', 'Affiliation': 'Digestive Disease Centre, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Surgery, Centre for Perioperative Optimisation, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}]",Frontiers in surgery,['10.3389/fsurg.2020.00025']
2636,19161542,Effect of combined maternal and infant vitamin D supplementation on vitamin D status of exclusively breastfed infants.,"Severe vitamin D deficiency in mothers and their breastfed infants is a significant health problem in the Middle East. Supplementation of the breastfed infant alone with the recommended dose of vitamin D may be insufficient in high-risk population. We investigated the effect of combined maternal and infant vitamin D supplementation on vitamin D status of the breastfed infant. We examined also the effect of supplementation on vitamin D antirachitic activity of breast milk in a subset of mothers. Healthy breastfeeding mothers (n = 90) were randomly assigned to 2000 IU daily (group 1) or 60,000 IU monthly (group 2) of vitamin D(2), and all their infants (n = 92) received 400 IU daily of vitamin D(2) for 3 months. Most infants had vitamin D deficiency - 25-hydroxyvitamin D [25(OH)D] <or= 37.5 nmol L(-1)- at study entry. Serum 25(OH)D concentrations at 3 months increased significantly from baseline in infants of mothers in group 1 (13.9 +/- 8.6 vs. 49.6 +/- 18.5 nmol L(-1), P < 0.0001) and group 2 (13.7 +/- 12.1 vs. 44.6 +/- 15.0 nmol L(-1), P < 0.0001). Maternal and infant serum 25(OH)D concentrations correlated positively at baseline (r = 0.36, P = 0.01) and 3 months (r = 0.46, P = 0.002). Milk antirachitic activity increased from undetectable (<20 IU L(-1)) to a median of 50.9 IU L(-1). In conclusion, combined maternal and infant vitamin D supplementation was associated with a threefold increase in infants' serum 25(OH)D concentrations and a 64% reduction in the prevalence of vitamin D deficiency without causing hypervitaminosis D.",2009,"Maternal and infant serum 25(OH)D concentrations correlated positively at baseline (r = 0.36, P = 0.01) and 3 months (r = 0.46, P = 0.002).","['Healthy breastfeeding mothers (n = 90', 'exclusively breastfed infants', 'breast milk in a subset of mothers', 'breastfed infant', 'Most infants had vitamin D deficiency - 25-hydroxyvitamin D [25(OH)D] <or= 37.5 nmol L(-1)- at study entry']","['vitamin D', 'combined maternal and infant vitamin D supplementation', 'vitamin D(2', '400 IU daily of vitamin D(2']","[""infants' serum 25(OH)D concentrations"", 'Milk antirachitic activity', 'Serum 25(OH)D concentrations', 'vitamin D status', 'Maternal and infant serum 25(OH)D concentrations', 'Severe vitamin D deficiency']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}, {'cui': 'C0439191', 'cui_str': 'nmol'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]",90.0,0.23597,"Maternal and infant serum 25(OH)D concentrations correlated positively at baseline (r = 0.36, P = 0.01) and 3 months (r = 0.46, P = 0.002).","[{'ForeName': 'Hussein F', 'Initials': 'HF', 'LastName': 'Saadi', 'Affiliation': 'Department of Internal Medicine, United Arab Emirates University, Al Ain, United Arab Emirates. saadih@uaeu.ac.ae'}, {'ForeName': 'Adekunle', 'Initials': 'A', 'LastName': 'Dawodu', 'Affiliation': ''}, {'ForeName': 'Bachar', 'Initials': 'B', 'LastName': 'Afandi', 'Affiliation': ''}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Zayed', 'Affiliation': ''}, {'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Benedict', 'Affiliation': ''}, {'ForeName': 'Nicolaas', 'Initials': 'N', 'LastName': 'Nagelkerke', 'Affiliation': ''}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2008.00145.x']
2637,31631481,Outcomes of single vs double surgeon for bilateral mastectomies.,,2020,,[],[],[],[],[],[],,0.372915,,"[{'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Schlegel', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Arsalan', 'Initials': 'A', 'LastName': 'Salamat', 'Affiliation': ""Division of Surgical Oncology, Department of Surgery, Magee-Women's Hospital, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Tane', 'Affiliation': ""Division of Surgical Oncology, Department of Surgery, Magee-Women's Hospital, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Joanna S', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': ""Division of Surgical Oncology, Department of Surgery, Magee-Women's Hospital, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Johnson', 'Affiliation': ""Division of Surgical Oncology, Department of Surgery, Magee-Women's Hospital, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Atilla', 'Initials': 'A', 'LastName': 'Soran', 'Affiliation': ""Division of Surgical Oncology, Department of Surgery, Magee-Women's Hospital, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.""}]",The breast journal,['10.1111/tbj.13664']
2638,32428430,Decision Aid Implementation among Left Ventricular Assist Device Programs Participating in the DECIDE-LVAD Stepped-Wedge Trial.,"Background.  Despite demonstrated efficacy, patient decision aids (DAs) are rarely used in clinical practice in the absence of coverage mandates. Deciding whether to pursue a left ventricular assist device (LVAD) is a major, preference-sensitive decision-ideal for exploring implementation of a DA.  Methods.  We conducted a type II effectiveness-implementation hybrid trial at 6 LVAD programs using a stepped-wedge cluster-randomized design. Using the RE-AIM framework, we collected both quantitative and qualitative outcomes, including a checklist collected by study staff for each enrolled patient regarding DA use and interviews with LVAD program clinicians preintervention, 6 months postintervention, and at the conclusion of the study.  Results.  From June 2015 to January 2017, 248 patients and their caregivers were enrolled. A total of 69 interviews were conducted with 48 clinicians at 3 time points. The DA reached 95% of eligible patients. Adoption was 100%, as all sites approached agreed to participate in the trial. Interviews revealed several themes related to the implementation of the DA: clinicians had a strong desire to ensure patients were informed and embraced the DA. Despite this, they reported communication challenges among their team that impeded implementation. Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation.  Conclusions.  In this hybrid trial, a DA for patients considering LVADs and their caregivers demonstrated high reach. Adoption and implementation were facilitated by a strong desire to ensure that patients were well informed. Future dissemination research and practice should attend to concerns about procedure volume and coverage mandates and facilitate ongoing communication at sites using the DA.",2020,Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation.  ,"['A total of 69 interviews were conducted with 48 clinicians at 3 time points', 'From June 2015 to January 2017, 248 patients and their caregivers were enrolled']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],69.0,0.0341025,Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation.  ,"[{'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'Veterans Affairs Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO, USA.'}, {'ForeName': 'Colleen K', 'Initials': 'CK', 'LastName': 'McIlvennan', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Jocelyn S', 'Initials': 'JS', 'LastName': 'Thompson', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Morris', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Venechuk', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Dunlay', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'LaRue', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Eldrin F', 'Initials': 'EF', 'LastName': 'Lewis', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Blue', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Chaussee', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Glasgow', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Mary Norine', 'Initials': 'MN', 'LastName': 'Walsh', 'Affiliation': 'St. Vincent Heart Center, Division of Cardiology, Indianapolis, IN, USA.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20915227']
2639,32430870,Preliminary effects of treating the half of high latent hyperopia on refractive and visual results of femtosecond laser-assisted in situ keratomileusis in subjects with hyperopia.,"BACKGROUND


To evaluate the preliminary effects of treating the half of high latent hyperopia on refractive and visual outcomes of femtosecond laser-assisted in situ keratomileusis (LASIK) in young subjects with hyperopia.
METHODS


This non-randomized comparative study includes 120 eyes of 60 subjects who underwent femtosecond LASIK to correct hyperopia. Group 1 (n = 60) includes subjects with ≤ 1D algebraic difference (DRSE) between cycloplegic (CRSE) and manifest (MRSE) refraction spherical equivalents and was treated by entering manifest refraction values. Group 2 includes subjects with > 1D DRSE and was treated by entering the mean manifest and cycloplegic refraction values. Refractive and subjective outcomes obtained at the 1-, 3-, and 6-month postoperative visits were compared.
RESULTS


The mean age of the subjects was 26.2 ± 3.5 and 26.2 ± 5.2 years for Group 1 and Group 2, respectively. The male-to-female ratios were 10/10 in both groups. Demographic values of the groups were similar (p > 0.05). Preoperative MRSE values were similar (p = 0.924), while CRSE and DRSE values were significantly higher in Group 2 (p < 0.001). At the 1- and 3-month postoperative visits, MRSE was higher and uncorrected distance visual acuity (UDVA) was lower in Group 2 (p < 0.001). Subjective visual parameters and quality of vision scores were also worse in Group 2 during these visits (p < 0.001); however, at the 6-month visit, all outcomes for Group 2 improved, and MRSE, UDVA, some subjective visual parameters, and quality of vision scores became similar between groups (p > 0.05).
CONCLUSION


At the 6-month visit after treating the half of > 1D latent hyperopia with femtosecond LASIK, refractive and visual outcomes like MRSE, UDVA, subjective visual parameters, and quality of vision scores become similar to those obtained in ≤ 1D latent hyperopia.",2020,"Subjective visual parameters and quality of vision scores were also worse in Group 2 during these visits (p < 0.001); however, at the 6-month visit, all outcomes for Group 2 improved, and MRSE, UDVA, some subjective visual parameters, and quality of vision scores became similar between groups (p > 0.05).
","['The mean age of the subjects was 26.2\u2009±\u20093.5 and 26.2\u2009±', 'young subjects with hyperopia', 'subjects with hyperopia', '120 eyes of 60 subjects who underwent femtosecond LASIK to correct hyperopia']","['femtosecond laser-assisted in situ keratomileusis (LASIK', 'femtosecond laser-assisted']","['Subjective visual parameters and quality of vision scores', 'uncorrected distance visual acuity (UDVA', 'MRSE, UDVA, some subjective visual parameters, and quality of vision scores', 'femtosecond LASIK, refractive and visual outcomes like MRSE, UDVA, subjective visual parameters, and quality of vision scores', 'CRSE and DRSE values', 'Demographic values', 'subjects with ≤\u20091D algebraic difference (DRSE) between cycloplegic (CRSE) and manifest (MRSE) refraction spherical equivalents', 'Preoperative MRSE values']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0020490', 'cui_str': 'Hypermetropia'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0339022', 'cui_str': 'Keratomileusis'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0339022', 'cui_str': 'Keratomileusis'}, {'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0339022', 'cui_str': 'Keratomileusis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0010586', 'cui_str': 'Cycloplegic preparation'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]",,0.0280514,"Subjective visual parameters and quality of vision scores were also worse in Group 2 during these visits (p < 0.001); however, at the 6-month visit, all outcomes for Group 2 improved, and MRSE, UDVA, some subjective visual parameters, and quality of vision scores became similar between groups (p > 0.05).
","[{'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Ozulken', 'Affiliation': 'Department of Ophthalmology, TOBB ETU, Ankara, Turkey.'}, {'ForeName': 'Cagri', 'Initials': 'C', 'LastName': 'Ilhan', 'Affiliation': 'Department of Ophthalmology, Hatay State Hospital, Antakya, Hatay, Turkey. cagriilhan@yahoo.com.'}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Yuksel', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Boston, MA, USA.'}, {'ForeName': 'Tarkan', 'Initials': 'T', 'LastName': 'Mumcuoglu', 'Affiliation': 'Department of Ophthalmology, TOBB ETU, Ankara, Turkey.'}]",International ophthalmology,['10.1007/s10792-020-01421-5']
2640,32427795,Feasibility Study of the Health Empowerment Intervention in Older Adults With Heart Failure.,"BACKGROUND


Of almost 5.7 million Americans with heart failure, 80% are 65 years and older. Empowerment approaches facilitating recognition of personal and social contextual resources may improve well-being in this vulnerable population.
OBJECTIVE


This research evaluated the feasibility of the Health Empowerment Intervention (HEI) in older adults with heart failure, including effects on health empowerment, purposeful participation, self-management, functional health, and well-being.
METHODS


Twenty older adults with heart failure were randomly assigned to HEI or Attention Control conditions. The HEI consisted of 6 weekly sessions based on the Health Empowerment Theory. Outcomes were measured at baseline and at 6 weeks.
RESULTS


Feasibility of the HEI was supported; participants realized significant improvement in health empowerment and purposeful participation in goal attainment.
CONCLUSIONS


This research supports the feasibility of the HEI and provides a basis for continued evaluation.",2020,"RESULTS


Feasibility of the HEI was supported; participants realized significant improvement in health empowerment and purposeful participation in goal attainment.
","['5.7 million Americans with heart failure', 'older adults with heart failure', 'Older Adults With Heart Failure', 'Twenty older adults with heart failure']","['HEI or Attention Control conditions', 'Health Empowerment Intervention (HEI', 'Health Empowerment Intervention']",['health empowerment and purposeful participation in goal attainment'],"[{'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",20.0,0.0373831,"RESULTS


Feasibility of the HEI was supported; participants realized significant improvement in health empowerment and purposeful participation in goal attainment.
","[{'ForeName': 'Ramesh Devi', 'Initials': 'RD', 'LastName': 'Thakur', 'Affiliation': ""Ramesh Devi Thakur, PhD, MSN, RN Assistant Professor, Mount Saint Mary's University, Los Angeles, California. Julie D. Fleury, PhD, RN, FAAN Professor, College of Nursing & Health Innovation, Arizona State University, Health North, Phoenix, Arizona. Nelma B. Crawford Shearer, PhD, RN, FAAN Associate Professor Emeritus, College of Nursing & Health Innovation, Arizona State University, Health North, Phoenix, Arizona. Michael Belyea, PhD Research Professor, College of Nursing & Health Innovation, Arizona State University.""}, {'ForeName': 'Julie D', 'Initials': 'JD', 'LastName': 'Fleury', 'Affiliation': ''}, {'ForeName': 'Nelma B', 'Initials': 'NB', 'LastName': 'Crawford Shearer', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Belyea', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000673']
2641,32427935,"Comparison of intradialytic versus home-based exercise programs on physical functioning, physical activity level, adherence, and health-related quality of life: pilot study.","Intradialytic exercise (ID) programs are effective and safe for hemodialysis (HD) patients to avoid functional deterioration. However, exercise is not routinely undertaken in most HD units, and we do not know if home-based (HB) programs are as effective as ID programs. The purpose of this study was to compare the effects of 16 weeks of ID exercise versus a HB exercise program for HD patients. A total of 46 patients were randomly assigned to the ID group (n = 24) or HB group (n = 22). They completed a 16-week combined exercise program 3 times/week. We measured physical activity level, physical functioning, depression level, and health-related quality of life at baseline and after 16 weeks. A significant time effect was found in both groups for the physical activity level (p = 0.012). There was also a significant group-time interaction effect for the one-leg standing test (OLST) (p = 0.049) and a significant time effect for the Short Physical Performance Battery (p = 0.013), timed up-and-go test (p = 0.005), sit-to-stand-10 (p = 0.027), right and left hand handgrip (p = 0.044, p < 0.001), one-heel left leg raise (p = 0.019), and 6-minute walking (p = 0.006), depression (p = 0.017). HRQoL remained unchanged. There was no difference between the two interventions on the tested outcomes (besides OLST). Both interventions were associated with positive changes of the physical activity levels and physical function.",2020,A significant time effect was found in both groups for the physical activity level (p = 0.012).,"['HD patients', '46 patients']","['Intradialytic exercise (ID) programs', 'HB', 'intradialytic versus home-based exercise programs', 'HB exercise program', 'ID exercise']","['time interaction effect', 'physical activity levels and physical function', 'physical functioning, physical activity level, adherence, and health-related quality of life', 'physical activity level, physical functioning, depression level, and health-related quality of life', 'one-heel left leg raise', 'HRQoL', 'Short Physical Performance Battery', 'leg standing test (OLST', 'depression', 'physical activity level', 'sit-to-stand-10', '6-minute walking']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0439232', 'cui_str': 'min'}]",46.0,0.0293592,A significant time effect was found in both groups for the physical activity level (p = 0.012).,"[{'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Ortega-Pérez de Villar', 'Affiliation': 'Department of Physical Therapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain. lucia.ortega@universidadeuropea.es.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Martínez-Olmos', 'Affiliation': 'Department of Physical Therapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Francisco de Borja', 'Initials': 'FB', 'LastName': 'Pérez-Domínguez', 'Affiliation': 'Department of Physical Therapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Vicent', 'Initials': 'V', 'LastName': 'Benavent-Caballer', 'Affiliation': 'Department of Physical Therapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Montañez-Aguilera', 'Affiliation': 'Department of Physical Therapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Mercer', 'Affiliation': 'Centre for Health, Activity and Rehabilitation Research School of Health Sciences, Queen Margaret University, Musselburgh, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Segura-Ortí', 'Affiliation': 'Department of Physical Therapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}]",Scientific reports,['10.1038/s41598-020-64372-y']
2642,32430879,Case presentation methods: a randomized controlled trial of the one-minute preceptor versus SNAPPS in a controlled setting.,"INTRODUCTION


One-minute preceptor (OMP) and SNAPPS (a mnemonic for Summarize history and findings; Narrow the differential; Analyze the differential; Probe the preceptor about uncertainties; Plan management; and Select case-related issues for self-study) are educational techniques developed to promote learners' expression of clinical reasoning during the case presentation in the workplace. The aim of this present study was to compare the content of the case presentation between the SNAPPS and the OMP methods.
METHODS


This was a randomized controlled trial comparing SNAPPS and OMP in 60 medical students at the beginning of their fifth year of medical school. After an introduction session, students presented and discussed two cases based on real patients and provided in written format. All case presentations were recorded and evaluated by two researchers. The assessed elements of the case presentations were divided into three subgroups related to expression of clinical reasoning, time and initiative to guide the presentation.
RESULTS


There were 30 participants in each group. There was no difference in the expression of clinical reasoning between OMP and SNAPPS groups (number of differential diagnoses, justification of most likely diagnosis and differential diagnosis, expression of comparing and contrasting hypotheses). However, students in the SNAPPS group expressed significantly more questions and uncertainties (p < 0.001), and more often took the initiative to present and justify the most likely diagnosis, differential diagnosis and management plan than students in the OMP group, both in simple and complex cases (all p values <0.001) without extending the length of the teaching session.
CONCLUSION


OMP and SNAPPS equally promote medical students' expression of clinical reasoning. The SNAPPS technique was more effective than the OMP technique in helping students to take on an active role during case presentation. We propose SNAPPS as an effective learning tool, engaging students and promoting the expression of their clinical reasoning as part of a case presentation.",2020,The SNAPPS technique was more effective than the OMP technique in helping students to take on an active role during case presentation.,['60 medical students at the beginning of their fifth year of medical school'],"['OMP technique', 'SNAPPS and OMP', 'OMP and SNAPPS', 'SNAPPS']","['expression of clinical reasoning', 'questions and uncertainties']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}]",60.0,0.0199239,The SNAPPS technique was more effective than the OMP technique in helping students to take on an active role during case presentation.,"[{'ForeName': 'Eleonora D T', 'Initials': 'EDT', 'LastName': 'Fagundes', 'Affiliation': 'Department of Pediatrics, Federal University of Minas Gerais, Belo Horizonte, Brazil. eleonoradruve@uol.com.br.'}, {'ForeName': 'Cássio C', 'Initials': 'CC', 'LastName': 'Ibiapina', 'Affiliation': 'Department of Pediatrics, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Cristina G', 'Initials': 'CG', 'LastName': 'Alvim', 'Affiliation': 'Department of Pediatrics, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Rachel A F', 'Initials': 'RAF', 'LastName': 'Fernandes', 'Affiliation': 'Department of Pediatrics, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Marco Antônio', 'Initials': 'MA', 'LastName': 'Carvalho-Filho', 'Affiliation': 'Department of Clinical Medicine, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Paul L P', 'Initials': 'PLP', 'LastName': 'Brand', 'Affiliation': 'Center for Education Development and Research in Health Professions, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands.'}]",Perspectives on medical education,['10.1007/s40037-020-00588-y']
2643,32428426,What Helps People Make Values-Congruent Medical Decisions? Eleven Strategies Tested across 6 Studies.,"Background.  High-quality health decisions are often defined as those that are both evidence informed and values congruent. A values-congruent decision aligns with what matters to those most affected by the decision. Values clarification methods are intended to support values-congruent decisions, but their effects on values congruence are rarely evaluated.  Methods.  We tested 11 strategies, including the 3 most commonly used values clarification methods, across 6 between-subjects online randomized experiments in demographically diverse US populations ( n 1 = 1346,  n 2 = 456,  n 3 = 840,  n 4 = 1178,  n 5 = 841,  n 6 = 2033) in the same hypothetical decision. Our primary outcome was values congruence. Decisional conflict was a secondary outcome in studies 3 to 6.  Results.  Two commonly used values clarification methods (pros and cons, rating scales) reduced decisional conflict but did not encourage values-congruent decisions. Strategies using mathematical models to show participants which option aligned with what mattered to them encouraged values-congruent decisions and reduced decisional conflict when assessed.  Limitations.  A hypothetical decision was necessary for ethical reasons, as we believed some strategies may harm decision quality. Later studies used more outcomes and covariates. Results may not generalize outside US-based adults with online access. We assumed validity and stability of values during the brief experiments.  Conclusions.  Failing to explicitly support the process of aligning options with values leads to increased proportions of values-incongruent decisions. Methods representing more than half of values clarification methods commonly in use failed to encourage values-congruent decisions. Methods that use models to explicitly show people how options align with their values offer more promise for helping people make decisions aligned with what matters to them. Decisional conflict, while arguably an important outcome in and of itself, is not an appropriate proxy for values congruence.",2020,"Two commonly used values clarification methods (pros and cons, rating scales) reduced decisional conflict but did not encourage values-congruent decisions.","['demographically diverse US populations ( n 1 = 1346,  n 2 = 456,  n 3 = 840,  n 4 = 1178,  n 5 = 841,  n 6 = 2033) in the same hypothetical decision']",[],"['Decisional conflict', 'decisional conflict']","[{'cui': 'C4708913', 'cui_str': '840'}]",[],"[{'cui': 'C0231394', 'cui_str': 'Decisional conflict'}]",,0.125062,"Two commonly used values clarification methods (pros and cons, rating scales) reduced decisional conflict but did not encourage values-congruent decisions.","[{'ForeName': 'Holly O', 'Initials': 'HO', 'LastName': 'Witteman', 'Affiliation': 'Universite Laval Faculte de medecine, Quebec, QC, Canada.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Julien', 'Affiliation': 'Universite Laval Faculte des sciences et de genie, Quebec, QC, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ndjaboue', 'Affiliation': 'Universite Laval Faculte de medecine, Quebec, QC, Canada.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Exe', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Valerie C', 'Initials': 'VC', 'LastName': 'Kahn', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Angie Fagerlin', 'Affiliation': 'University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Zikmund-Fisher', 'Affiliation': 'University of Michigan School of Public Health, Ann Arbor, MI, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20904955']
2644,32428059,Effect of violet LED light on in-office bleaching protocols: a randomized controlled clinical trial.,"Objective This study evaluated the clinical effect of violet LED light on in-office bleaching used alone or combined with 37% carbamide peroxide (CP) or 35% hydrogen peroxide (HP). Methodology A total of 100 patients were divided into five groups (n=20): LED, LED/CP, CP, LED/HP and HP. Colorimetric evaluation was performed using a spectrophotometer (ΔE, ΔL, Δa, Δb) and a visual shade guide (ΔSGU). Calcium (Ca)/phosphorous (P) ratio was quantified in the enamel microbiopsies. Measurements were performed at baseline (T 0 ), after bleaching (T B ) and in the 14-day follow-up (T 14 ). At each bleaching session, a visual scale determined the absolute risk (AR) and intensity of tooth sensitivity (TS). Data were evaluated by one-way (ΔE, Δa, ΔL, Δb), two-way repeated measures ANOVA (Ca/P ratio), and Tukey post-hoc tests. ΔSGU and TS were evaluated by Kruskal-Wallis and Mann-Whitney, and AR by Chi-Squared tests (a=5%). Results LED produced the lowest ΔE (p<0.05), but LED/HP promoted greater ΔE, ΔSGU and Δb (T 14 ) than HP (p<0.05). No differences were observed in ΔE and ΔSGU for LED/CP and HP groups (p>0.05). ΔL and Δa were not influenced by LED activation. After bleaching, LED/CP exhibited greater Δb than CP (p>0.05), but no differences were found between these groups at T 14 (p>0.05). LED treatment promoted the lowest risk of TS (16%), while HP promoted the highest (94.4%) (p<0.05). No statistical differences of risk of TS were found for CP (44%), LED/CP (61%) and LED/HP (88%) groups (p>0.05). No differences were found in enamel Ca/P ratio among treatments, regardless of evaluation times. Conclusions Violet LED alone produced the lowest bleaching effect, but enhanced HP bleaching results. Patients treated with LED/CP reached the same efficacy of HP, with reduced risk and intensity of tooth sensitivity and none of the bleaching protocols adversely affected enamel mineral content.",2020,"Results LED produced the lowest ΔE (p<0.05), but LED/HP promoted greater ΔE, ΔSGU and Δb (T 14 ) than HP (p<0.05).",['100 patients were divided into five groups (n=20'],"['LED/CP', 'LED, LED/CP, CP, LED/HP and HP', 'combined with 37% carbamide peroxide (CP) or 35% hydrogen peroxide (HP', 'violet LED light']","['risk of TS', 'enamel mineral content', 'lowest risk of TS', 'Calcium (Ca)/phosphorous (P) ratio', 'enamel Ca/P ratio', 'visual scale determined the absolute risk (AR) and intensity of tooth sensitivity (TS', 'efficacy of HP, with reduced risk and intensity of tooth sensitivity']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]",100.0,0.02735,"Results LED produced the lowest ΔE (p<0.05), but LED/HP promoted greater ΔE, ΔSGU and Δb (T 14 ) than HP (p<0.05).","[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Kury', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Erica Eiko', 'Initials': 'EE', 'LastName': 'Wada', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Daylana Pacheco da', 'Initials': 'DPD', 'LastName': 'Silva', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Cínthia Pereira Machado', 'Initials': 'CPM', 'LastName': 'Tabchoury', 'Affiliation': 'Departamento de Ciências Fisiológicas, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Giannini', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Cavalli', 'Affiliation': 'Departamento de Odontologia Restauradora, Faculdade de Odontologia de Piracicaba, Universidade Estadual de Campinas, Piracicaba, SP, Brasil.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2019-0720']
2645,32427792,Comparison of Silicone Sheets and Paper Tape for the Management of Postoperative Scars: A Randomized Comparative Study.,"OBJECTIVE


To compare the effectiveness of silicone sheets and paper tape in the prevention of postoperative cesarean section scars.
METHODS


Patients undergoing horizontal cesarean section were included in this randomized controlled trial. Surgical wounds were divided into two halves. Patients randomly applied silicone sheets or paper tape to each side of their wound as assigned for 3 months. Wounds were assessed at 1, 3, 6, and 12 months after surgery. Researchers used the objective Vancouver Scar Scale (VSS) to evaluate the scars and the subjective visual analog scale (VAS) to evaluate itch, pain, and scar appearance.
RESULTS


No significant differences between the silicone sheet and paper tape groups were noted at postoperative follow-ups with respect to VSS scores. The silicone sheet group had significantly better VAS scores for scar appearance than the paper tape group at 6 (6.81 ± 1.47 vs 6.19 ± 1.62, P = .03) and 12 (6.88 ± 2.01 vs 6.2 ± 2.08, P = .04) months' follow-up, respectively.
CONCLUSIONS


The silicone sheet group showed statistically significant differences in comparison with the paper tape group in terms of scar appearance as determined by the VAS. However, the differences were too small to be clinically meaningful.",2020,No significant differences between the silicone sheet and paper tape groups were noted at postoperative follow-ups with respect to VSS scores.,"['Postoperative Scars', 'Patients undergoing horizontal cesarean section']","['silicone sheets or paper tape', 'Silicone Sheets and Paper Tape', 'silicone sheets and paper tape']","['subjective visual analog scale (VAS) to evaluate itch, pain, and scar appearance', 'scar appearance', 'VAS scores for scar appearance', 'objective Vancouver Scar Scale (VSS']","[{'cui': 'C0334150', 'cui_str': 'Surgical scar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0228907,No significant differences between the silicone sheet and paper tape groups were noted at postoperative follow-ups with respect to VSS scores.,"[{'ForeName': 'Ying-Sheng', 'Initials': 'YS', 'LastName': 'Lin', 'Affiliation': 'Ying-Sheng Lin, MD, MPH, is a resident; Pei-San Ting, MSc, is a research assistant; and Kuei-Chang Hsu, MD, is Attending Physician, Division of Plastic and Reconstructive Surgery, Kaohsiung Veterans General Hospital, Taiwan. Acknowledgments: The authors appreciate the support and cooperation of the patients in this study, who were referred by Dr Wen-Shiung Liou, Dr Fu-Nan Cho, Dr San-Nung Chen, Dr Kuan-Hao Tsui, and Dr Ju-Yueh Li in the Department of Obstetrics and Gynecology. A version of this article was presented at the Annual Meeting of the American Society of Plastic Surgery in Los Angeles, California, in September 2016. The authors have disclosed no financial relationships related to this article. Submitted March 28, 2017; accepted in revised form December 19, 2017.'}, {'ForeName': 'Pei-San', 'Initials': 'PS', 'LastName': 'Ting', 'Affiliation': ''}, {'ForeName': 'Kuei-Chang', 'Initials': 'KC', 'LastName': 'Hsu', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000661932.67974.7d']
2646,32428027,Effects of the Community Score Card approach on reproductive health service-related outcomes in Malawi.,"BACKGROUND


Social accountability approaches are increasingly being employed in low-resource settings to improve government services. In line with the continuous quality improvement (CQI) philosophy that quality is the product of a linked chain, collaborative social accountability approaches like the Community Score Card (CSC) aim to empower clients and frontline service providers to transform their own lives and hold public officials to account for state obligations. Despite being a critical focus of collaborative social accountability approaches, to our knowledge, a quantitative survey of health workers to understand the impact of these approaches on their self-reported responsibilities and service provision has not been conducted. To fill this gap, we carried out a quantitative survey with health workers to assess the CSC's impact on health worker-reported service responsibilities and provision and complement women's self-reports.
METHODS


We evaluated the effect of the CSC on reproductive health-related outcomes using a cluster-randomized design in Ntcheu district, Malawi. We matched 10 pairs of health facilities and surrounding catchment communities; one from each pair was randomly assigned to the intervention and control arms. The intervention communities and health workers each completed 3-4 cycles of the CSC process by endline. We then surveyed all health workers in the 20 intervention and comparison sites at endline (n = 412) to estimate the intervention's impact.
RESULTS


Significantly (p < .05) more health workers in the CSC intervention areas compared to control areas reported responsibility for antenatal care, comprehensive antenatal care counseling, recording of the number of pregnant and postpartum women seen each month, and the average age of their last family planning client was younger. In addition, marginally significantly (p < .10) more health workers in treatment versus control areas report visiting women at their home at least once during their pregnancy. However, health worker-reported responsibility for HIV testing was significantly lower in intervention areas than in control.
CONCLUSIONS


The CSC aims to empower health workers to collaborate with the community and rest of the health system to identify and overcome the diverse and context-specific range of performance barriers they face. In doing so, it aims to support them to demand and ensure quality care for themselves from the health system so they can, in turn, deliver quality services to clients. Our results contribute to the evidence that the CSC may hold promise at improving service provision. While there is increasing evidence that collaborative social accountability approaches like the CSC are effective means to improving reproductive health-related service provision and outcomes in low-resource settings, additional research is needed.",2020,"Significantly (p < .05) more health workers in the CSC intervention areas compared to control areas reported responsibility for antenatal care, comprehensive antenatal care counseling, recording of the number of pregnant and postpartum women seen each month, and the average age of their last family planning client was younger.","['surveyed all health workers in the 20 intervention and comparison sites at endline (n = 412', 'reproductive health service-related outcomes in Malawi', 'We matched 10 pairs of health facilities and surrounding catchment communities']","['Community Score Card approach', 'CSC']",['health workers'],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1136000', 'cui_str': 'Reproductive Health Services'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",,0.064098,"Significantly (p < .05) more health workers in the CSC intervention areas compared to control areas reported responsibility for antenatal care, comprehensive antenatal care counseling, recording of the number of pregnant and postpartum women seen each month, and the average age of their last family planning client was younger.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gullo', 'Affiliation': 'CARE USA, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Galavotti', 'Affiliation': 'CARE USA, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sebert Kuhlmann', 'Affiliation': 'College for Public Health & Social Justice, Saint Louis University, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Thumbiko', 'Initials': 'T', 'LastName': 'Msiska', 'Affiliation': 'CARE Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Hastings', 'Affiliation': 'Far Harbor, LLC, Austin, TX, United States of America.'}, {'ForeName': 'C Nathan', 'Initials': 'CN', 'LastName': 'Marti', 'Affiliation': 'Far Harbor, LLC, Austin, TX, United States of America.'}]",PloS one,['10.1371/journal.pone.0232868']
2647,32428369,Susceptibility-guided therapy for Helicobacter pylori-infected penicillin-allergic patients: A prospective clinical trial of first-line and rescue therapies.,"BACKGROUND


Helicobacter pylori (H pylori) treatment remains a challenge for penicillin-allergic patients.
AIM


To evaluate the efficacy and tolerability of susceptibility-guided first-line and rescue treatment in H pylori-infected penicillin-allergic patients.
METHODS


Consecutive H pylori-infected patients with penicillin allergy received a 14-day triple or quadruple therapy based on susceptibility to clarithromycin, levofloxacin, and metronidazole. All received esomeprazole 20 mg twice a day. Metronidazole-susceptible infections received metronidazole plus clarithromycin or levofloxacin triple therapy if susceptible. Clarithromycin- and levofloxacin-resistant infections received metronidazole plus tetracycline triple therapy. Metronidazole-resistant infections received a bismuth-high-dose metronidazole plus clarithromycin or levofloxacin quadruple therapy. Triple-resistant infections received classical bismuth quadruple therapy with high-dose metronidazole. Antimicrobial susceptibility was assessed using the E test method.
RESULTS


112 patients were entered (34.8% men, average 47.1 years). Infections in 83.8% (31/37) of treatment-naive subjects and 12.0% (9/75) (P < .001) receiving rescue treatment were susceptible to at least one of the three tested antibiotics. Overall, susceptibility-guided therapy achieved eradication rates of 92.9% (104/112, 95% CI 88.1%-97.7%) by intent-to-treat analysis and 99% (100/101, 95% CI 97.1%-100%) by per-protocol analysis. All regimens achieved eradication rates greater than 90% (P = .327) in the PP populations. Adverse events were relatively frequent; however, compliance remained high.
CONCLUSION


Susceptibility-guided therapy proved highly effective for penicillin-allergic patients. When available and proven locally effective, the alternative was empiric classical bismuth quadruple therapy. This trial is registered with ClinicalTrials.gov as NCT03708848.",2020,"Overall, susceptibility-guided therapy achieved eradication rates of 92.9% (104/112, 95% CI 88.1%-97.7%) by intent-to-treat analysis and 99% (100/101, 95% CI 97.1%-100%) by per-protocol analysis.","['H pylori-infected penicillin-allergic patients', 'penicillin-allergic patients', '112 patients were entered (34.8% men, average 47.1\xa0years', 'Consecutive H pylori-infected patients with penicillin allergy received a', 'Helicobacter pylori-infected penicillin-allergic patients']","['bismuth-high-dose metronidazole plus clarithromycin or levofloxacin quadruple therapy', 'Susceptibility-guided therapy', 'metronidazole plus tetracycline triple therapy', 'esomeprazole', 'metronidazole plus clarithromycin', '14-day triple or quadruple therapy', 'levofloxacin triple therapy', 'Metronidazole', 'Clarithromycin- and levofloxacin', 'classical bismuth quadruple therapy with high-dose metronidazole', 'clarithromycin, levofloxacin, and metronidazole', 'susceptibility-guided first-line']","['Adverse events', 'Antimicrobial susceptibility', 'efficacy and tolerability', 'eradication rates', 'Infections']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030824', 'cui_str': 'Allergy to penicillin'}]","[{'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0427965', 'cui_str': 'Antimicrobial susceptibility - finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",112.0,0.034533,"Overall, susceptibility-guided therapy achieved eradication rates of 92.9% (104/112, 95% CI 88.1%-97.7%) by intent-to-treat analysis and 99% (100/101, 95% CI 97.1%-100%) by per-protocol analysis.","[{'ForeName': 'Laisheng', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yingjie', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lou', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}]",Helicobacter,['10.1111/hel.12699']
2648,32428148,Investigating gender differences for effectiveness and side effects of varenicline during smoking cessation treatment.,"Varenicline is a useful pharmacological option for smoking cessation. Unfortunately, there is a lack of studies on its effectiveness, retention, and side effects in low- and middle-income countries. The present study aimed to investigate gender differences regarding these outcomes in a Brazilian clinical sample (n = 124). The 12-week treatment protocol included six consultations with a psychiatrist and six sessions of cognitive-behavioral therapy. All subjects received varenicline on the first evaluation, following the standard posology for 12 weeks and instructions to stop smoking after the second week of treatment. Both Mini-International Neuropsychiatric Interview (MINI) Plus and Fagerstrom Test for Nicotine Dependence were applied at baseline. The UKU-Side Effects Rating Scale was administered at weeks 3, 7, and 11, and the Questionnaire of Smoking Urges-Brief at weeks 1, 5, and 9 to ascertain the side effects of the medication and craving, respectively. At the end of the 12-week treatment, abstinence was biochemically assessed. At months 6 and 12 after the treatment, follow-up telephone interviews were conducted to access nicotine abstinence. Short- and long-term abstinence and retention rates did not differ between genders. However, women presented more side effects than men, especially in the second half of the treatment. Increased dream activity, reduced duration of sleep, constipation, and weight loss were the most notable side effects. Despite women reporting more side effects than men, this difference did not influence the treatment success rates.",2020,Short- and long-term abstinence and retention rates did not differ between genders.,['Brazilian clinical sample (n = 124'],"['Mini-International Neuropsychiatric Interview (MINI', 'psychiatrist and six sessions of cognitive-behavioral therapy', 'Varenicline', 'varenicline']","['Short- and long-term abstinence and retention rates', 'Increased dream activity, reduced duration of sleep, constipation, and weight loss', 'side effects']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517553', 'cui_str': '124'}]","[{'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013117', 'cui_str': 'Dream'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",124.0,0.020755,Short- and long-term abstinence and retention rates did not differ between genders.,"[{'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Castellani', 'Affiliation': '. Departamento e Instituto de Psiquiatria, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'Priscila Dib', 'Initials': 'PD', 'LastName': 'Gonçalves', 'Affiliation': '. Departamento e Instituto de Psiquiatria, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'João Mauricio', 'Initials': 'JM', 'LastName': 'Castaldelli-Maia', 'Affiliation': '. Departamento e Instituto de Psiquiatria, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Malbergier', 'Affiliation': '. Departamento e Instituto de Psiquiatria, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brasil.'}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.66.2.146']
2649,19034493,Procalcitonin (PCT)-guided algorithm reduces length of antibiotic treatment in surgical intensive care patients with severe sepsis: results of a prospective randomized study.,"BACKGROUND


Adequate indication and duration of administration are central issues of modern antibiotic treatment in intensive care medicine. The biochemical variable procalcitonin (PCT) is known to indicate systemically relevant bacterial infections with high accuracy. In the present study, we aimed to investigate the clinical usefulness of PCT for guiding antibiotic treatment in surgical intensive care patients with severe sepsis.
PATIENTS AND METHODS


Patients were randomly assigned to a PCT-guided or a control group requiring antibiotic treatment. All patients received a calculated antibiotic regimen according to the presumed microbiological spectrum. In the PCT-guided group, antibiotic treatment was discontinued if clinical signs of infection improved and the PCT value was either <1 ng/ml or decreased to <35% of the initial concentration within three consecutive days. In the control group, antibiotic treatment was directed by empirical rules.
RESULTS


The PCT-guided group (n = 14 patients) and the control group (n = 13 patients) did not differ in terms of biological variables, underlying diseases, and overall disease severity. PCT guidance led to a significant reduction of antibiotic treatment from 6.6 +/- 1.1 days (mean +/- SD) compared with 8.3 +/- 0.7 days in control patients (p < 0.001) along with a reduction of antibiotic treatment costs of 17.8% (p < 0.01) without any adverse effects on outcome.
CONCLUSIONS


Monitoring of PCT is a helpful tool for guiding antibiotic treatment in surgical intensive care patients with severe sepsis. This may contribute to an optimized antibiotic regimen with beneficial effects on microbial resistances and costs in intensive care medicine.",2009,"0.7 days in control patients (p < 0.001) along with a reduction of antibiotic treatment costs of 17.8% (p < 0.01) without any adverse effects on outcome.
","['Patients', 'surgical intensive care patients with severe sepsis']","['PCT', 'Procalcitonin (PCT)-guided algorithm', 'PCT-guided or a control group requiring antibiotic treatment']","['antibiotic treatment costs', 'biological variables, underlying diseases, and overall disease severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086476', 'cui_str': 'Surgical Intensive Care'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}]","[{'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002045'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.025489,"0.7 days in control patients (p < 0.001) along with a reduction of antibiotic treatment costs of 17.8% (p < 0.01) without any adverse effects on outcome.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schroeder', 'Affiliation': 'Interdisciplinary Intensive Care Unit, Department of Anaesthesiology and Intensive Care Medicine, Westküstenklinikum, Heide, Germany. sschroeder@wkk-hei.de'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hochreiter', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Koehler', 'Affiliation': ''}, {'ForeName': 'A-M', 'Initials': 'AM', 'LastName': 'Schweiger', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bein', 'Affiliation': ''}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Keck', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'von Spiegel', 'Affiliation': ''}]",Langenbeck's archives of surgery,['10.1007/s00423-008-0432-1']
2650,32428066,Effect of an interdisciplinary intervention with motivational approach on exercise capacity in obese adolescents: a randomized controlled clinical trial.,"Objective To evaluate the effect of an interdisciplinary intervention with a motivational approach on exercise capacity and usual physical activity levels in overweight and obese adolescents. Methods This is a randomized, controlled clinical trial with single blinding of subjects. Adolescents aged 15 to 18 years with overweight and obesity (body mass index ≥ 85 percentile) were included. The adolescents were randomized into two groups: interdisciplinary intervention or control - traditional approach aiming at lifestyle modifications. The initial evaluations were carried out, including the cardiopulmonary exercise test and the physical activity level measurement by using the International Physical Activity Questionnaire and a pedometer. The evaluations were performed in two moments: time zero (time of inclusion in the study) and after 3 months (end of intervention). There were 12 sessions with weekly meetings. Results A total of 37 participants were included, 19 in the Intervention Group. There were no significant differences in the baseline demographic, anthropometric and physical activity characteristics between groups, with mean age of 17.3±1.0 years in the Control Group, and 16.8±0.9 years in the Intervention Group (p=0.14). The motivational intervention did not cause significant differences (p>0.05) in the comparison of the variables of exercise capacity and usual physical activity (questionnaire and pedometer) between groups. Conclusion The intervention with a motivational approach did not alter exercise capacity and levels of usual physical activity in overweight and obese adolescents. Clinical Trial Registry: NCT02455973 and REBEC: RBR-234nb5.",2020,The motivational intervention did not cause significant differences (p>0.05) in the comparison of the variables of exercise capacity and usual physical activity (questionnaire and pedometer) between groups.,"['overweight and obese adolescents', 'subjects', 'Adolescents aged 15 to 18 years with overweight and obesity (body mass index ≥ 85 percentile', 'obese adolescents', 'A total of 37 participants were included, 19 in the Intervention Group']","['interdisciplinary intervention with a motivational approach', 'RBR-234nb5', 'interdisciplinary intervention or control - traditional approach aiming at lifestyle modifications', 'interdisciplinary intervention with motivational approach']","['exercise capacity and levels of usual physical activity', 'exercise capacity and usual physical activity levels', 'baseline demographic, anthropometric and physical activity characteristics', 'exercise capacity', 'exercise capacity and usual physical activity (questionnaire and pedometer']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",37.0,0.0502785,The motivational intervention did not cause significant differences (p>0.05) in the comparison of the variables of exercise capacity and usual physical activity (questionnaire and pedometer) between groups.,"[{'ForeName': 'Letiane Bueno', 'Initials': 'LB', 'LastName': 'Zanatta', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Heinzmann-Filho', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Fernanda Maria', 'Initials': 'FM', 'LastName': 'Vendrusculo', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Natália Evangelista', 'Initials': 'NE', 'LastName': 'Campos', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Margareth da Silva', 'Initials': 'MDS', 'LastName': 'Oliveira', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ana Maria Pandolfo', 'Initials': 'AMP', 'LastName': 'Feoli', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Andréia da Silva', 'Initials': 'ADS', 'LastName': 'Gustavo', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Márcio Vinícius Fagundes', 'Initials': 'MVF', 'LastName': 'Donadio', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}]","Einstein (Sao Paulo, Brazil)",['10.31744/einstein_journal/2020ao5268']
2651,19020859,Iron lung versus mask ventilation in acute exacerbation of COPD: a randomised crossover study.,"OBJECTIVE


To compare iron lung (ILV) versus mask ventilation (NPPV) in the treatment of COPD patients with acute on chronic respiratory failure (ACRF).
DESIGN


Randomised multicentre study.
SETTING


Respiratory intermediate intensive care units very skilled in ILV.
PATIENTS AND METHODS


A total of 141 patients met the inclusion criteria and were assigned: 70 to ILV and 71 to NPPV. To establish the failure of the technique employed as first line major and minor criteria for endotracheal intubation (EI) were used. With major criteria EI was promptly established. With at least two minor criteria patients were shifted from one technique to the other.
RESULTS


On admission, PaO(2)/FiO(2), 198 (70) and 187 (64), PaCO(2), 90.5 (14.1) and 88.7 (13.5) mmHg, and pH 7.25 (0.04) and 7.25 (0.05), were similar for ILV and NPPV groups. When used as first line, the success of ILV (87%) was significantly greater (P = 0.01) than NPPV (68%), due to the number of patients that met minor criteria for EI; after the shift of the techniques; however, the need of EI and hospital mortality was similar in both groups. The total rate of success using both techniques increased from 77.3 to 87.9% (P = 0.028).
CONCLUSIONS


The sequential use of NPPV and ILV avoided EI in a large percentage of COPD patients with ACRF; ILV was more effective than NPPV on the basis of minor criteria for EI but after the crossover the need of EI on the basis of major criteria and mortality was similar in both groups of patients.",2009,"The total rate of success using both techniques increased from 77.3 to 87.9% (P = 0.028).
","['Respiratory intermediate intensive care units very skilled in ILV', 'acute exacerbation of COPD', '141 patients met the inclusion criteria and were assigned: 70 to ILV and 71 to NPPV', 'COPD patients with acute on chronic respiratory failure (ACRF']","['Iron lung versus mask ventilation', 'iron lung (ILV) versus mask ventilation (NPPV']","['success of ILV', 'total rate of success', 'need of EI and hospital mortality']","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0264491', 'cui_str': 'Acute-on-chronic respiratory failure (disorder)'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}]",,0.0434143,"The total rate of success using both techniques increased from 77.3 to 87.9% (P = 0.028).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Corrado', 'Affiliation': ""Unita' di Terapia Intensiva Pneumologica e, Fisiopatologia Toracica, DAI, Specialità medico-Chirurgiche, Azienda Ospedaliera Universitaria Careggi, Padiglione San Luca,Via di S. Luca 1, 50136, Florence, Italy. acorrado@qubisoft.it""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gorini', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Melej', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Baglioni', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mollica', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Villella', 'Affiliation': ''}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Consigli', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dottorini', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bigioni', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Toschi', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Eslami', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-008-1352-9']
2652,32428202,The work of older people and their informal caregivers in managing an acute health event in a hospital at home or hospital inpatient setting.,"BACKGROUND


There is limited understanding of the contribution made by older people and their caregivers to acute healthcare in the home and how this compares to hospital inpatient healthcare.
OBJECTIVES


To explore the work of older people and caregivers at the time of an acute health event, the interface with professionals in a hospital and hospital at home (HAH) and how their experiences relate to the principles underpinning comprehensive geriatric assessment (CGA).
DESIGN


A qualitative interview study within a UK multi-site participant randomised trial of geriatrician-led admission avoidance HAH, compared with hospital inpatient care.
METHODS


We conducted semi-structured interviews with 34 older people (15 had received HAH and 19 hospital care) alone or alongside caregivers (29 caregivers; 12 HAH, 17 hospital care), in three sites that recruited participants to a randomised trial, during 2017-2018. We used normalisation process theory to guide our analysis and interpretation of the data.
RESULTS


Patients and caregivers described efforts to understand changes in health, interpret assessments and mitigate a lack of involvement in decisions. Practical work included managing risks, mobilising resources to meet health-related needs, and integrating the acute episode into longer-term strategies. Personal, relational and environmental factors facilitated or challenged adaptive capacity and ability to manage.
CONCLUSIONS


Patients and caregivers contributed to acute healthcare in both locations, often in parallel to healthcare providers. Our findings highlight an opportunity for CGA-guided services at the interface of acute and chronic condition management to facilitate personal, social and service strategies extending beyond an acute episode of healthcare.",2020,"Our findings highlight an opportunity for CGA-guided services at the interface of acute and chronic condition management to facilitate personal, social and service strategies extending beyond an acute episode of healthcare.","['34 older people (15 had received HAH and 19 hospital care) alone or alongside caregivers (29 caregivers; 12 HAH, 17 hospital care), in three sites that recruited participants to a randomised trial, during 2017-2018', 'older people and their informal caregivers in managing an acute health event in a hospital at home or hospital inpatient setting', 'older people and caregivers at the time of an acute health event, the interface with professionals in a hospital and hospital at home (HAH']",['geriatrician-led admission avoidance HAH'],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0586872', 'cui_str': 'Geriatrics specialist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],,0.105641,"Our findings highlight an opportunity for CGA-guided services at the interface of acute and chronic condition management to facilitate personal, social and service strategies extending beyond an acute episode of healthcare.","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Mäkelä', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stott', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Godfrey', 'Affiliation': 'Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Ellis', 'Affiliation': 'Monklands Hospital, NHS Lanarkshire, Glasgow, UK.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Schiff', 'Affiliation': ""Department of Ageing and Health, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Shepperd', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}]",Age and ageing,['10.1093/ageing/afaa085']
2653,32432137,Removal of biofilm is essential for long-term ventilation tube retention.,"BACKGROUND


Although long-term retention of a ventilation tube is required in many ear diseases, spontaneous removal of conventional ventilation tube is observed in patients within 3 to 12 mo. To address this issue, we aimed to determine a new method for long-term retention of the ventilation tube.
AIM


To explore the value of removing the biofilm for long-term retention of tympanostomy ventilation tubes.
METHODS


A case-control study design was used to evaluate the safety and effectiveness of long-term tube retention by directly removing the biofilm ( via  surgical exfoliation) in patients who underwent myringotomy with ventilation tube placement. The patients were randomly divided into two groups: Control group and treatment group. Patients in the treatment group underwent regular biofilm exfoliation surgery in the clinic, whereas those in the control group did not have their biofilm removed. Only conventional ventilation tubes were placed in this study. Outcome measures were tube position and patency. Tube retention time and any complications were documented.
RESULTS


Eight patients with biofilm removal and eight patients without biofilm removal as a control group were enrolled in the study. The tympanostomy tube retention time was significantly longer in the treatment group (43.5 ± 26.4 mo) than in the control group (9.5 ± 6.9 mo) ( P  = 0.003). More tympanostomy tubes were found to be patent and in correct position in the treatment group during the follow-up intervals than in the control group ( P  = 0.01).
CONCLUSION


Despite the use of short-term ventilation tubes, direct biofilm removal can be a well-tolerated and effective treatment for long-term tube retention of tympanostomy ventilation tubes in patients who underwent myringotomy.",2020,"More tympanostomy tubes were found to be patent and in correct position in the treatment group during the follow-up intervals than in the control group ( P  = 0.01).
","['Eight patients with biofilm removal and eight patients without biofilm removal as a control group were enrolled in the study', 'patients who underwent myringotomy with ventilation tube placement']","['conventional ventilation tubes', 'regular biofilm exfoliation surgery', 'short-term ventilation tubes', 'long-term tube retention by directly removing the biofilm ( via  surgical exfoliation']","['safety and effectiveness', 'tympanostomy tube retention time', 'Tube retention time and any complications', 'tube position and patency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087123', 'cui_str': 'Tympanostomy'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0040439', 'cui_str': 'Exfoliation of teeth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0175566', 'cui_str': 'Open'}]",8.0,0.0137541,"More tympanostomy tubes were found to be patent and in correct position in the treatment group during the follow-up intervals than in the control group ( P  = 0.01).
","[{'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': ""Department of Otorhinolaryngology-Head & Neck Surgery, the Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Otorhinolaryngology-Head & Neck Surgery, the Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233, China.""}, {'ForeName': 'Zheng-Nong', 'Initials': 'ZN', 'LastName': 'Chen', 'Affiliation': ""Department of Otorhinolaryngology-Head & Neck Surgery, the Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233, China.""}, {'ForeName': 'Ya-Qin', 'Initials': 'YQ', 'LastName': 'Wu', 'Affiliation': ""Department of Otorhinolaryngology-Head & Neck Surgery, the Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233, China.""}, {'ForeName': 'Dong-Zhen', 'Initials': 'DZ', 'LastName': 'Yu', 'Affiliation': ""Department of Otorhinolaryngology-Head & Neck Surgery, the Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233, China.""}, {'ForeName': 'Peng-Jun', 'Initials': 'PJ', 'LastName': 'Wang', 'Affiliation': ""Department of Otorhinolaryngology-Head & Neck Surgery, the Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233, China. wangpj@sjtu.edu.cn.""}, {'ForeName': 'Hai-Bo', 'Initials': 'HB', 'LastName': 'Shi', 'Affiliation': ""Department of Otorhinolaryngology-Head & Neck Surgery, the Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233, China.""}, {'ForeName': 'Kai-Ming', 'Initials': 'KM', 'LastName': 'Su', 'Affiliation': ""Department of Otorhinolaryngology-Head & Neck Surgery, the Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233, China.""}]",World journal of clinical cases,['10.12998/wjcc.v8.i9.1592']
2654,31791858,"Corrigendum to ""Design and participant characteristics of TX sprouts: A school-based cluster randomized gardening, nutrition, and cooking intervention"" [Contemp Clin Trials 85 (2019) 105834].",,2020,,[],[],[],[],[],[],,0.0595127,,"[{'ForeName': 'Jaimie N', 'Initials': 'JN', 'LastName': 'Davis', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA. Electronic address: Jaimie.davis@austin.utexas.edu.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Nikah', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Asigbee', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Landry', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Sarvenaz', 'Initials': 'S', 'LastName': 'Vandyousefi', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Ghaddar', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hoover', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jeans', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Pont', 'Affiliation': 'Department of Pediatrics, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'Texas A&M AgriLife Extension Service, Travis County, USA.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Hoelscher', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Health Promotion and Behavioral Sciences, UTHealth School of Public Health, Austin Campus, Austin, USA.'}, {'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Van Den Berg', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Health Promotion and Behavioral Sciences, UTHealth School of Public Health, Austin Campus, Austin, USA.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Bluestein', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Biostatistics and Data Science, University of Texas Health (UTHealth) Science Center, Austin Regional Campus, Austin, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Pérez', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Biostatistics and Data Science, University of Texas Health (UTHealth) Science Center, Austin Regional Campus, Austin, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105906']
2655,32428227,The role of the inferior parietal lobule in writer's cramp.,"Humans have a distinguishing ability for fine motor control that is subserved by a highly evolved cortico-motor neuronal network. The acquisition of a particular motor skill involves a long series of practice movements, trial and error, adjustment and refinement. At the cortical level, this acquisition begins in the parieto-temporal sensory regions and is subsequently consolidated and stratified in the premotor-motor cortex. Task-specific dystonia can be viewed as a corruption or loss of motor control confined to a single motor skill. Using a multimodal experimental approach combining neuroimaging and non-invasive brain stimulation, we explored interactions between the principal nodes of the fine motor control network in patients with writer's cramp and healthy matched controls. Patients and healthy volunteers underwent clinical assessment, diffusion-weighted MRI for tractography, and functional MRI during a finger tapping task. Activation maps from the task-functional MRI scans were used for target selection and neuro-navigation of the transcranial magnetic stimulation. Single- and double-pulse TMS evaluation included measurement of the input-output recruitment curve, cortical silent period, and amplitude of the motor evoked potentials conditioned by cortico-cortical interactions between premotor ventral (PMv)-motor cortex (M1), anterior inferior parietal lobule (aIPL)-M1, and dorsal inferior parietal lobule (dIPL)-M1 before and after inducing a long term depression-like plastic change to dIPL node with continuous theta-burst transcranial magnetic stimulation in a randomized, sham-controlled design. Baseline dIPL-M1 and aIPL-M1 cortico-cortical interactions were facilitatory and inhibitory, respectively, in healthy volunteers, whereas the interactions were converse and significantly different in writer's cramp. Baseline PMv-M1 interactions were inhibitory and similar between the groups. The dIPL-PMv resting state functional connectivity was increased in patients compared to controls, but no differences in structural connectivity between the nodes were observed. Cortical silent period was significantly prolonged in writer's cramp. Making a long term depression-like plastic change to dIPL node transformed the aIPL-M1 interaction to inhibitory (similar to healthy volunteers) and cancelled the PMv-M1 inhibition only in the writer's cramp group. These findings suggest that the parietal multimodal sensory association region could have an aberrant downstream influence on the fine motor control network in writer's cramp, which could be artificially restored to its normal function.",2020,"The dIPL-PMv resting state functional connectivity was increased in patients compared to controls, but no differences in structural connectivity between the nodes were observed.","[""patients with writer's cramp and healthy matched controls"", ""writer's cramp"", 'Patients and healthy volunteers', 'healthy volunteers']","['motor evoked potentials conditioned by cortico-cortical interactions between premotor ventral (PMv)-motor cortex (M1), anterior inferior parietal lobule (aIPL)-M1, and dorsal inferior parietal lobule (dIPL)-M1 before and after inducing a long term depression-like plastic change to dIPL node with continuous theta-burst transcranial magnetic stimulation', 'multimodal experimental approach combining neuroimaging and non-invasive brain stimulation', 'Single- and double-pulse TMS']","['structural connectivity', 'Baseline dIPL-M1 and aIPL-M1 cortico-cortical interactions', 'dIPL-PMv resting state functional connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154676', 'cui_str': ""Organic writer's cramp""}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0232120', 'cui_str': 'Double pulse'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0340364', 'cui_str': 'Familial mitral valve prolapse'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0317236,"The dIPL-PMv resting state functional connectivity was increased in patients compared to controls, but no differences in structural connectivity between the nodes were observed.","[{'ForeName': 'Shabbir Hussain I', 'Initials': 'SHI', 'LastName': 'Merchant', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Frangos', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Bradson', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tianxia', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Vial-Undurraga', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Leodori', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Bushnell', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Silvina G', 'Initials': 'SG', 'LastName': 'Horovitz', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hallett', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Traian', 'Initials': 'T', 'LastName': 'Popa', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}]",Brain : a journal of neurology,['10.1093/brain/awaa138']
2656,18818542,Effect of environmental changes on noise in the NICU.,"PURPOSE


To evaluate die effect of changes in die NICU environment on sound levels.
DESIGN


A prospective quasi-experimental design evaluated sound levels in a 43-bed NICU. Decibel levels were monitored utilizing a data-logging dosimeter for 24 hours weekly over 12 months. Sound levels were also measured inside four different incubator models.
SAMPLE


Forty-four 24-hour decibel recordings were obtained in one of eight randomly selected four-bed pods. In addition, a single 1-hour recording was obtained in four different models of vacant incubators.
MAIN OUTCOME VARIABLE


Ambient sound levels.
RESULTS


Decibel levels were analyzed to identify changes in noise levels following alterations in the NICU environment. Installation of motion-sensing motorized paper towel holders significantly increased levels at beds closest to the towel dispensers, as did the trial of a new communication system. Decibel levels in four different incubators revealed varying noise levels. This study suggests that all environmental changes must be monitored to ensure that they reduce rather than increase noise levels.",2008,"Installation of motion-sensing motorized paper towel holders significantly increased levels at beds closest to the towel dispensers, as did the trial of a new communication system.",[],[],"['Sound levels', 'Decibel levels']",[],[],"[{'cui': 'C0428754', 'cui_str': 'Sound level (observable entity)'}, {'cui': 'C0439497', 'cui_str': 'decibel'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0231528,"Installation of motion-sensing motorized paper towel holders significantly increased levels at beds closest to the towel dispensers, as did the trial of a new communication system.","[{'ForeName': 'Debra H', 'Initials': 'DH', 'LastName': 'Brandon', 'Affiliation': 'Duke University School of Nursing Durham, NC 27710, USA. debra.brandon@duke.edu'}, {'ForeName': 'Donna J', 'Initials': 'DJ', 'LastName': 'Ryan', 'Affiliation': ''}, {'ForeName': 'Angel H', 'Initials': 'AH', 'LastName': 'Barnes', 'Affiliation': ''}]",Advances in neonatal care : official journal of the National Association of Neonatal Nurses,['10.1097/01.ANC.0000337266.47599.c9']
2657,18811792,Effectiveness of a community-based responsive feeding programme in rural Bangladesh: a cluster randomized field trial.,"Responsive complementary feeding, whereby the mother feeds her child in response to child cues of hunger state and psychomotor abilities, is a problem in some countries, and likely contributes to malnutrition. Interventions are needed to evaluate whether promoting responsive feeding would add any benefit. Using a cluster randomized field trial, we evaluated a six-session educational programme that emphasized practice of two key behaviours, namely child self-feeding and maternal responsiveness. One hundred mothers and their 12- to 24-month-olds attended the sessions as part of village clusters randomly assigned to the intervention group. A similar number of controls received sessions on foods to feed and nutritional disorders. Outcomes assessed at pre-test, 2-week post-intervention and again 5-months post-intervention included weight, mouthfuls of food taken, self-feeding and maternal responsiveness. Research assistants, blind to group assignment, observed and coded mother and child behaviours during the midday meal. Secondary measures included foods fed and feeding messages recalled. Analysis was based on intention to treat and accounted for clustering. Only 10% of each group was lost to follow-up. Weight (d = 0.28), weight gain (d = 0.48) and child self-feeding (d = 0.30) were significantly higher in the responsive feeding group. Mouthfuls of food eaten and maternal responsiveness were not significantly increased by the intervention. Mothers in the intervention gave their children more vegetables, and spontaneously recalled more feeding messages at the 5-month follow-up. These results provide evidence that self-feeding and weight gain can improve by targeting specific behaviours, while maternal responsiveness may require more intensive strategies.",2008,"Mothers in the intervention gave their children more vegetables, and spontaneously recalled more feeding messages at the 5-month follow-up.","['One hundred mothers and their 12- to 24-month-olds attended the sessions as part of village clusters randomly assigned to the intervention group', 'rural Bangladesh']",['community-based responsive feeding programme'],"['Mouthfuls of food eaten and maternal responsiveness', 'Weight', 'weight, mouthfuls of food taken, self-feeding and maternal responsiveness', 'weight gain', 'child self-feeding']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",100.0,0.0390814,"Mothers in the intervention gave their children more vegetables, and spontaneously recalled more feeding messages at the 5-month follow-up.","[{'ForeName': 'Frances E', 'Initials': 'FE', 'LastName': 'Aboud', 'Affiliation': 'Department of Psychology, McGill University, Montreal, Quebec, Canada. Frances.Aboud@mcgill.ca'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Sadika', 'Initials': 'S', 'LastName': 'Akhter', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/j.1740-8709.2008.00146.x']
2658,32428341,"Changing Sedentary Behavior in the Office: A Randomised Controlled Trial Comparing the Effect of Affective, Instrumental, and Self-Regulatory Messaging on Sitting.","BACKGROUND


Although avoiding sedentary behavior has many health benefits, adults often sit for long periods at work. The purpose of this study was to compare affective attitude, instrumental attitude, and self-regulation messaging interventions on sitting in the workplace.
METHODS


Using a cluster randomised controlled trial design, participants (N = 116) were assigned (by workplace) to: (a) instrumental, (b) affective, (c) self-regulation, or (d) control (nutrition information) groups. Measurements were taken online at baseline, 4 weeks, 8 weeks, and 12 weeks post-baseline. The interventions comprised three presentations delivered following baseline, week 4, and week 8 assessments. The primary outcome was self-reported average hours of sitting per day at work (registered trial number: NCT04082624).
RESULTS


Controlling for baseline sitting, overall, the affective group sat for less time than the instrumental and self-regulation groups. Also, at week 4, the affective group sat for less time than the instrumental and self-regulation groups and, at week 8, the affective group sat for less time than the self-regulation and control groups. There were no differences between the groups at week 12.
CONCLUSIONS


This investigation showed that workplace interventions targeting affective attitude can lead to less sitting time in the short term. Future research should explore additional strategies to minimise sedentary behavior in the long term.",2020,"RESULTS


Controlling for baseline sitting, overall, the affective group sat for less time than the instrumental and self-regulation groups.",['participants (N\xa0=\xa0116'],[],"['sitting time', 'self-reported average hours of sitting per day at work (registered trial number: NCT04082624']","[{'cui': 'C4517541', 'cui_str': '116'}]",[],"[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",116.0,0.0563669,"RESULTS


Controlling for baseline sitting, overall, the affective group sat for less time than the instrumental and self-regulation groups.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lithopoulos', 'Affiliation': 'University of Victoria, Victoria, BC, Canada.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Kaushal', 'Affiliation': 'Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Beauchamp', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conner', 'Affiliation': 'University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'de Bruijn', 'Affiliation': 'University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Latimer-Cheung', 'Affiliation': ""Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Rhodes', 'Affiliation': 'University of Victoria, Victoria, BC, Canada.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12202']
2659,32432443,Plantar Flexor Strength Training With Home-Based Neuromuscular Electrical Stimulation Improves Limits of Postural Stability in Older Adults.,"BACKGROUND


The study aimed to determine whether improved muscle strength after 12 weeks of neuromuscular electrical stimulation (NMES) of plantar and dorsiflexors could result in better limits of stability in older adults.
METHODS


Twenty-seven participants were divided into a control group and a neuromuscular home-based training group. The training group performed a 3-month long NMES training of both plantar and dorsiflexors. Ankle flexor strength and limits of stability were measured. A mediation analysis was conducted to determine whether the NMES effect on the limits of stability was mediated by increased strength.
RESULTS


The NMES training increased plantar flexor strength (+47%; β = 0.217, P = .02), and this increase predicted the anterior limits of stability improvement (+27%; β = 0.527, P = .02). The effect of the NMES on the limits of stability was fully mediated by the plantar flexor strength increase (indirect effect: β = 0.1146; 95% confidence interval, 0.020-0.240).
CONCLUSION


It seems that NMES improves the limits of stability through its positive effect on muscle strength. NMES may be utilized in fall-prevention programs.",2020,"The NMES training increased plantar flexor strength (+47%; β = 0.217, P = .02), and this increase predicted the anterior limits of stability improvement (+27%; β = 0.527, P = .02).","['Twenty-seven participants', 'Older Adults', 'older adults']","['neuromuscular electrical stimulation (NMES) of plantar and dorsiflexors', 'NMES training of both plantar and dorsiflexors', 'NMES', 'neuromuscular home-based training group', 'Plantar Flexor Strength Training With Home-Based Neuromuscular Electrical Stimulation']","['plantar flexor strength', 'anterior limits of stability improvement', 'plantar flexor strength increase', 'Postural Stability', 'Ankle flexor strength and limits of stability']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}]",27.0,0.0483137,"The NMES training increased plantar flexor strength (+47%; β = 0.217, P = .02), and this increase predicted the anterior limits of stability improvement (+27%; β = 0.527, P = .02).","[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Langeard', 'Affiliation': ''}, {'ForeName': 'Lucile', 'Initials': 'L', 'LastName': 'Bigot', 'Affiliation': ''}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Loggia', 'Affiliation': ''}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Chastan', 'Affiliation': ''}, {'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Quarck', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Gauthier', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0501']
2660,32432388,"Lorecivivint, a Novel Intra-articular CLK/DYRK1A Inhibitor and Wnt Pathway Modulator for Treatment of Knee Osteoarthritis: A Phase 2 Randomized Trial.","OBJECTIVE


To assess the safety and efficacy of the novel Wnt pathway modulator lorecivivint (SM04690) for treating pain and inhibiting structural progression in moderate-to-severe symptomatic knee osteoarthritis (OA).
METHODS


Subjects in this 52-week, Phase 2a, multicenter, randomized, double-blind, placebo (PBO)-controlled, dose-ranging trial received a single, 2 mL, intra-articular injection of 0.03 mg, 0.07 mg, or 0.23 mg lorecivivint, or PBO. Efficacy was assessed by change in WOMAC Pain [0-100] and WOMAC Function [0-100] subscales and radiographic medial joint space width (mJSW). Baseline-adjusted analysis of covariance with multiple imputation was performed separately to evaluate efficacy. This proof-of-concept study evaluated the intention-to-treat population as well as a prespecified group of subjects with unilateral symptoms (UNI) and an additional post hoc subgroup of unilateral symptomatic subjects without widespread pain (UNI WP-).
RESULTS


Four hundred fifty-five subjects were randomized. The primary endpoint, improvement in WOMAC Pain compared with PBO at Week 13, was not met by any dose group (change from baseline, 0.03 mg, -23.3±2.2; 0.07 mg, -23.5±2.1; 0.23 mg, -21.3±2.2; PBO, -22.1±2.1; all P>0.05). All groups (including PBO) demonstrated clinically meaningful (≥20-point) improvements from baseline. The durability of response was evaluated through Week 52. In the prespecified UNI and post hoc UNI WP-groups at Week 52, 0.07 mg lorecivivint significantly improved WOMAC Pain (between-group differences [95% CIs]: UNI, -8.73 [-17.44, -0.03], P=0.049; UNI WP-, -11.21 [-20.99, -1.43], P=0.025) and WOMAC Function (UNI, -10.26 [-19.82, -0.69], P=0.036; UNI WP-, -13.38 [-24.33, -2.43], P=0.017) compared with PBO. Compared with baseline, the mean change in mJSW at Week 52 was -0.04 mm in the 0.03 mg cohort, -0.09 mm in the 0.07 mg cohort, -0.16 mm in the 0.23 mg cohort, and -0.14 mm in the PBO cohort; no treatment group achieved a statistically significant change in mJSW compared with PBO at Week 52. In both unilateral subgroups, the 0.07 mg dose significantly increased mJSW compared with PBO at 52 weeks, (UNI, 0.39 mm [0.06, 0.72], P=0.021; UNI WP-, 0.42 mm [0.04, 0.80], P=0.032). Changes in the 0.03 mg and 0.23 mg dose groups were not statistically different from PBO in any of these measures. Lorecivivint appeared safe and well tolerated.
CONCLUSION


This Phase 2a, proof-of-concept trial did not meet its primary endpoint; however, it identified a target population in which to evaluate the potential efficacy of lorecivivint.",2020,"The primary endpoint, improvement in WOMAC Pain compared with PBO at Week 13, was not met by any dose group (change from baseline, 0.03 mg, -23.3±2.2; 0.07 mg, -23.5±2.1; 0.23 mg, -21.3±2.2; PBO, -22.1±2.1; all P>0.05).","['Subjects', 'Four hundred fifty-five subjects were randomized', 'Knee Osteoarthritis', 'subjects with unilateral symptoms (UNI) and an additional post hoc subgroup of unilateral symptomatic subjects without widespread pain (UNI WP', 'moderate-to-severe symptomatic knee osteoarthritis (OA']","['placebo (PBO)-controlled', 'novel Wnt pathway modulator lorecivivint (SM04690']","['mean change in mJSW', 'mJSW', 'durability of response', 'WOMAC Pain [0-100] and WOMAC Function [0-100] subscales and radiographic medial joint space width (mJSW', 'safety and efficacy', 'Efficacy', 'safe and well tolerated', 'WOMAC Function', 'WOMAC Pain']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1520113', 'cui_str': 'Wnt Pathway'}, {'cui': 'C4706114', 'cui_str': 'SM04690'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",455.0,0.138937,"The primary endpoint, improvement in WOMAC Pain compared with PBO at Week 13, was not met by any dose group (change from baseline, 0.03 mg, -23.3±2.2; 0.07 mg, -23.5±2.1; 0.23 mg, -21.3±2.2; PBO, -22.1±2.1; all P>0.05).","[{'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Yazici', 'Affiliation': 'Samumed LLC, San Diego, California, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'McAlindon', 'Affiliation': 'Tufts Medical Center, Division of Rheumatology, Boston, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Gibofsky', 'Affiliation': 'Weill Cornell Medical College, New York, USA.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Lane', 'Affiliation': 'U.C. Davis Medical School, Medicine, Burlingame, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Clauw', 'Affiliation': 'University of Michigan, Internal Medicine, Ann Arbor, USA.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Cleveland Clinic, Orthopaedic Surgery, Cleveland, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bergfeld', 'Affiliation': 'Cleveland Clinic, Cleveland, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Swearingen', 'Affiliation': 'Samumed LLC, San Diego, California, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'DiFrancesco', 'Affiliation': 'Samumed LLC, San Diego, California, USA.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Simsek', 'Affiliation': 'Samumed LLC, San Diego, California, USA.'}, {'ForeName': 'Jeyanesh', 'Initials': 'J', 'LastName': 'Tambiah', 'Affiliation': 'Samumed LLC, San Diego, California, USA.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Hochberg', 'Affiliation': 'Univ Maryland, baltiomre, USA.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41315']
2661,32432326,"Intrauterine insemination performance characteristics and post-processing total motile sperm count in relation to live birth for couples with unexplained infertility in a randomised, multicentre clinical trial.","STUDY QUESTION


Are intrauterine insemination (IUI) performance characteristics and post-processing total motile sperm count (TMC) related to live birth rate in couples with unexplained infertility?
SUMMARY ANSWER


Patient discomfort with IUI and lower inseminate TMC were associated with a reduced live birth rate, while time from hCG injection to IUI, sperm preparation method and ultrasound guidance for IUI were not associated with live birth success.
WHAT IS ALREADY KNOWN


We previously determined that some baseline characteristics of couples with unexplained infertility, including female age, duration of infertility, history of prior loss and income, were related to live birth rate across a course of ovarian stimulation and IUI treatment. However, the relationship between treatment outcomes and per-cycle characteristics, including ultrasound guidance for IUI, timing of IUI relative to hCG injection, difficult or painful IUI and inseminate TMC, are controversial, and most prior investigations have not evaluated live birth outcome.
STUDY DESIGN, SIZE, DURATION


This was a secondary analyses of 2462 cycles from the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial. This prospective, randomised, multicentre clinical trial determined live birth rates following IUI after ovarian stimulation with clomiphene citrate, letrozole or gonadotropins in 854 couples with unexplained infertility. It was conducted between 2011 and 2014, and couples could undergo up to four consecutive treatment cycles.
PARTICIPANTS/MATERIALS, SETTING, METHODS


AMIGOS was an NIH-sponsored Reproductive Medicine Network trial conducted at 12 clinical sites. Participants were women with unexplained infertility who were between 18 and 40 years of age. Cluster-weighted generalised estimating equations (GEE), which account for informative clustering of multiple IUI treatment cycles within the same patient, were used to determine associations between IUI performance characteristics, including inseminate TMC, and live birth rate. Efficiency curves were also generated to examine the relationship between inseminate TMC and live birth rate.
MAIN RESULTS AND THE ROLE OF CHANCE


After adjustment for treatment group and baseline factors previously associated with live birth across a course of OS-IUI treatment, patient discomfort during the IUI procedure was associated with a reduction in live birth rate (aRR 0.40 (0.16-0.96)). Time from hCG trigger injection to IUI was not significantly associated with outcome. Higher TMC was associated with greater live birth rate (TMC 15.1-20.0 million (14.8%) compared to ≤5 million (5.5%)) (aRR 2.09 (1.31-3.33)). However, live births did occur with TMC ≤ 1 million (5.1%).
LIMITATIONS, REASONS FOR CAUTION


This investigation is a secondary analysis, and AMIGOS was not designed to address the present question. Since timed intercourse was allowed as part of the AMIGOS trial, we cannot rule out the possibility that any given pregnancy resulted from intercourse rather than IUI.
WIDER IMPLICATIONS OF THE FINDINGS


Most factors associated with the performance of IUI were not significantly related to obtaining live birth. Our findings suggest that higher TMC inseminated leads to an increase in live birth rate up to TMC ~20 million. However, there may be no reasonable threshold below which live birth is not possible with IUI.
STUDY FUNDING/COMPETING INTEREST(S)


Funding was received through grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): U10 HD077680, U10 HD39005, U10 HD38992, U10 HD27049, U10 HD38998, U10 HD055942, HD055944, U10 HD055936 and U10 HD055925. This research was made possible by funding by the American Recovery and Reinvestment Act. Dr Hansen reports grants from NIH/NICHD and Yale University during the conduct of the study, grants from Roche Diagnostics and grants from Ferring International Pharmascience Center US outside the submitted work. Dr Peck reports support from Ferring Pharmaceuticals outside the submitted work. Dr Coward has nothing to disclose. Dr Wild reports grants from NICHD during the conduct of the study. Dr Trussell has nothing to disclose. Dr Krawetz reports grants from NICHD during the conduct of the study, grants from Merck and support from Taylor and Frances and from Springer, outside the submitted work. Dr Diamond reports grants from NIH/NICHD, Yale University, during the conduct of the study and support from Advanced Reproductive Care AbbVie, Bayer and ObsEva, outside the submitted work. Dr Legro reports support from Bayer, Kindex, Odega, Millendo and AbbVie and grants and support from Ferring, outside the submitted work. Dr Coutifaris reports grants from NICHD/NIH and personal fees from American Society for Reproductive Medicine, outside the submitted work. Dr Alvero has nothing to disclose. Dr Robinson reports grants from NIH during the conduct of the study. Dr Casson has nothing to disclose. Dr Christman reports grants from NICHD during the conduct of the study. Dr Santoro reports grants from NIH during the conduct of the study. Dr Zhang reports grants from NIH during the conduct of the study and support from Shangdong University outside the submitted work.
TRIAL REGISTRATION NUMBER


n/a.",2020,"SUMMARY ANSWER


Patient discomfort with IUI and lower inseminate TMC were associated with a reduced live birth rate, while time from hCG injection to IUI, sperm preparation method and ultrasound guidance for IUI were not associated with live birth success.
","['Participants were women with unexplained infertility who were between 18 and 40\xa0years of age', 'AMIGOS was an NIH-sponsored Reproductive Medicine Network trial conducted at 12 clinical sites', '854 couples with unexplained infertility', '2462\xa0cycles from the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial', '2011 and 2014, and couples could undergo up to four consecutive treatment cycles', 'couples with unexplained infertility']","['intrauterine insemination (IUI) performance characteristics and post-processing total motile sperm count (TMC', 'clomiphene citrate, letrozole or gonadotropins', 'Intrauterine insemination performance characteristics and post-processing total motile sperm count']","['live birth across a course of OS-IUI treatment, patient discomfort', 'live birth rate', 'ultrasound guidance for IUI, timing of IUI relative to hCG injection, difficult or painful IUI and inseminate TMC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0242668', 'cui_str': 'Medicine, Reproductive'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0449935', 'cui_str': 'Post-processing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",854.0,0.111279,"SUMMARY ANSWER


Patient discomfort with IUI and lower inseminate TMC were associated with a reduced live birth rate, while time from hCG injection to IUI, sperm preparation method and ultrasound guidance for IUI were not associated with live birth success.
","[{'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Peck', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'R Matthew', 'Initials': 'RM', 'LastName': 'Coward', 'Affiliation': 'Department of Urology, UNC School of Medicine, 2113 Physicians Office Building CB#7235, Chapel Hill, NC 27599-7235, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wild', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Trussell', 'Affiliation': 'Department of Urology, Upstate University Hospital, 750 East Adams Street, Syracuse, NY 13210, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Krawetz', 'Affiliation': 'Department of Obstetrics and Gynecology and Molecular Medicine and Genetics, Wayne State University School of Medicine, Detroit, MI 48201, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, MI 48201, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, PA 17033, USA.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Alvero', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado Denver, Aurora, CO 80045, USA.'}, {'ForeName': 'Randal D', 'Initials': 'RD', 'LastName': 'Robinson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Health Science Center at San Antonio, TX 78229, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Casson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Vermont, Burlington, VT 05446, USA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Christman', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado Denver, Aurora, CO 80045, USA.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT 06520, USA.'}, {'ForeName': 'For The Nichd Reproductive', 'Initials': 'FTNR', 'LastName': 'Medicine Network', 'Affiliation': ''}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa027']
2662,32432339,Time course of 75%-100% efficacy response of adjunctive brivaracetam.,"BACKGROUND


Time to sustained seizure frequency reduction can provide clinically meaningful epilepsy outcomes.
AIMS OF THE STUDY


Examine the time course of brivaracetam (BRV) efficacy in adults with focal seizures and focal to bilateral tonic-clonic seizures (FBTCS).
METHODS


Post hoc analysis of data pooled from three randomized controlled trials of oral adjunctive BRV in adults with epilepsy. Patients with focal epilepsy and a subpopulation with FBTCS receiving BRV 50, 100, or 200 mg/d (initiated without up-titration) or placebo for 12 weeks were analyzed for time to sustained ≥75%, ≥90%, and 100% seizure reduction without interruption from first day until trial end.
RESULTS


Evaluation included 1160 patients with focal seizures, including 352 patients with FBTCS. Sustained ≥75%, ≥90%, and 100% response in focal seizures was higher from day 1 for BRV 100 and 200 mg/d vs placebo (P <.01). Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P <.01).
CONCLUSIONS


The majority of patients achieving 75%-100% sustained seizure frequency reduction (all focal seizure types and the subpopulation with FBTCS) with oral BRV (100 or 200 mg/d) achieved this response on the first treatment day.",2020,"Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P <.01).
","['1160 patients with focal seizures, including 352 patients with FBTCS', 'Patients with focal epilepsy and a subpopulation with FBTCS receiving BRV 50, 100, or 200 mg/d (initiated without up-titration) or', 'adults with focal seizures and focal to bilateral tonic-clonic seizures (FBTCS', 'adults with epilepsy']","['oral adjunctive BRV', 'adjunctive brivaracetam', 'oral BRV', 'placebo']","['focal seizures', 'time course of brivaracetam (BRV) efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1160.0,0.262434,"Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P <.01).
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Laloyaux', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA.'}]",Acta neurologica Scandinavica,['10.1111/ane.13287']
2663,32432356,Comment on: Comparison of the duration of hospital stay after laparoscopic or open distal pancreatectomy: randomized controlled trial.,,2020,,[],['laparoscopic or open distal pancreatectomy'],['hospital stay'],[],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.113769,,"[{'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Tongde\u2009Hospital\u2009of\u2009Zhejiang\u2009Province, Hangzhou, China.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery, Tongde\u2009Hospital\u2009of\u2009Zhejiang\u2009Province, Hangzhou, China.'}]",The British journal of surgery,['10.1002/bjs.11680']
2664,32432142,Cholesteryl ester storage disease of clinical and genetic characterisation: A case report and review of literature.,"BACKGROUND


Cholesteryl ester storage disease (CESD) is a rare genetic disease. Its symptoms and severity are highly variable. CESD is a systemic disease that can lead to the accumulation of fat and inflammation in the liver, as well as gastrointestinal and cardiovascular disease. The majority of patients require liver transplantation due to decompensated cirrhosis. Enzyme replacement therapy has been approved based on a randomized trial. Our study aims to clinically and genetically evaluate two siblings with CESD who underwent liver transplantation, as well as their first-degree family members.
CASE SUMMARY


The siblings were compound heterozygous for the missense variant in  LIPA  exon 8, c.894G>A, (p.Gln298Gln) and a single base pair deletion, c.482del (p.Asn161Ilefs*19). Analyses of single nucleotide polymorphisms showed variants with an increased risk of fatty liver disease and fibrosis for both patients. Clinically, both patients show signs of recurrence of CESD in the liver after transplantation and additional gastrointestinal and cardiovascular signs of CESD. Three family members who were  LIPA  heterozygous had a lysosomal acid lipase activity below the reference value. One of these carriers, a seven-year-old boy, was found to have severe dyslipidemia and was subsequently treated with statins.
CONCLUSION


Our study underlines that CESD is a multi-organ disease, the progression of which may occur post-liver transplantation. Our findings underline the need for monitoring of complications and assessment of possible further treatment.",2020,"The siblings were compound heterozygous for the missense variant in  LIPA  exon 8, c.894G>A, (p.","['patients require liver transplantation due to decompensated cirrhosis', 'siblings with CESD who underwent liver transplantation, as well as their first-degree family members', 'Cholesteryl ester storage disease of clinical and genetic characterisation']","['CESD', 'Enzyme replacement therapy']","['risk of fatty liver disease and fibrosis', 'lysosomal acid lipase activity', 'signs of recurrence of CESD', 'severe dyslipidemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0008384', 'cui_str': 'Cholesterol ester storage disease'}, {'cui': 'C0444502', 'cui_str': 'First degree'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}]","[{'cui': 'C0008384', 'cui_str': 'Cholesterol ester storage disease'}, {'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0544512', 'cui_str': 'Lysosomal Acid Lipase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0008384', 'cui_str': 'Cholesterol ester storage disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}]",,0.0345959,"The siblings were compound heterozygous for the missense variant in  LIPA  exon 8, c.894G>A, (p.","[{'ForeName': 'Elias Badal', 'Initials': 'EB', 'LastName': 'Rashu', 'Affiliation': 'Gastrounit, Copenhagen University Hospital Hvidovre, Hvidovre 2650, Denmark.'}, {'ForeName': 'Anders Ellekær', 'Initials': 'AE', 'LastName': 'Junker', 'Affiliation': 'Gastrounit, Copenhagen University Hospital Hvidovre, Hvidovre 2650, Denmark.'}, {'ForeName': 'Karen Vagner', 'Initials': 'KV', 'LastName': 'Danielsen', 'Affiliation': 'Gastrounit, Copenhagen University Hospital Hvidovre, Hvidovre 2650, Denmark.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Dahl', 'Affiliation': 'Department of Hepatology, Rigshospitalet, Copenhagen University, Copenhagen 2100, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Hamberg', 'Affiliation': 'Department of Hepatology, Rigshospitalet, Copenhagen University, Copenhagen 2100, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Borgwardt', 'Affiliation': 'Centre of Genomic Medicine, Rigshospitalet, Copenhagen University, Copenhagen 2100, Denmark.'}, {'ForeName': 'Vibeke Brix', 'Initials': 'VB', 'LastName': 'Christensen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen University, Copenhagen 2100, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Novo Nordisk Foundation Center for Protein Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen 2200, Denmark.'}, {'ForeName': 'Lise L', 'Initials': 'LL', 'LastName': 'Gluud', 'Affiliation': 'Gastrounit, Copenhagen University Hospital Hvidovre, Hvidovre 2650, Denmark. lise.lotte.gluud.01@regionh.dk.'}]",World journal of clinical cases,['10.12998/wjcc.v8.i9.1642']
2665,18656314,"Differences between daily smokers, chippers, and nonsmokers with co-occurring anxiety and alcohol-use disorders.","Tobacco use is disproportionately represented among both alcohol-use disorders (AUDs) and anxiety disorders (ANX) compared to the general population [Kalman, D. A., Morissette, S. B., & George, T. P. (2005). Co-morbidity of nicotine and tobacco use in psychiatric and substance use disorders. The American Journal on Addictions, 14, 1-18]. Despite this common overlap, little is known about how smokers with co-occurring AUD-ANX differ from their nonsmoking counterparts. Seventy-two patients participated in a larger clinical trial evaluating the efficacy of venlafaxine and cognitive-behavioral therapy for AUD-ANX. Differences between daily smokers (n=23), chippers (n=12) and nonsmokers (n=37) with AUD-ANX were examined with respect to intensity and frequency of alcohol use, anxiety symptoms, depressed mood, and stress. Point prevalence of current daily smoking was 31.9%, which is considerably lower than traditionally reported in AUD studies. Consistent with predictions, daily smokers reported higher levels of alcohol dependence, average drinks per drinking occasion, and peak blood concentration levels in a day than nonsmokers during the 90 days prior to assessment. Chippers were nonsignificantly different from either smokers or nonsmokers. Smokers and nonsmokers did not differ with respect to percent heavy drinking days or emotional symptoms.",2008,Smokers and nonsmokers did not differ with respect to percent heavy drinking days or emotional symptoms.,"['daily smokers (n=23), chippers (n=12) and nonsmokers (n=37) with AUD-ANX']","['venlafaxine and cognitive-behavioral therapy for AUD-ANX', 'nicotine and tobacco']","['heavy drinking days or emotional symptoms', 'intensity and frequency of alcohol use, anxiety symptoms, depressed mood, and stress', 'alcohol dependence, average drinks per drinking occasion, and peak blood concentration levels']","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",72.0,0.0118364,Smokers and nonsmokers did not differ with respect to percent heavy drinking days or emotional symptoms.,"[{'ForeName': 'Sandra B', 'Initials': 'SB', 'LastName': 'Morissette', 'Affiliation': 'VA Boston Healthcare System, USA; Boston University School of Medicine, USA; Boston University Department of Psychology, USA. Electronic address: Sandra.Morissette@va.gov.'}, {'ForeName': 'Suzy B', 'Initials': 'SB', 'LastName': 'Gulliver', 'Affiliation': 'Central Texas Veterans Healthcare System, USA; Texas A&M, USA.'}, {'ForeName': 'Barbara W', 'Initials': 'BW', 'LastName': 'Kamholz', 'Affiliation': 'VA Boston Healthcare System, USA; Boston University School of Medicine, USA; Boston University Department of Psychology, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Duade', 'Affiliation': 'Boston University Department of Psychology, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Farchione', 'Affiliation': 'Boston University Department of Psychology, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Devine', 'Affiliation': 'Boston University School of Medicine, USA.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Brown', 'Affiliation': 'Boston University Department of Psychology, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Boston University Department of Psychology, USA; Boston University School of Medicine, USA.'}, {'ForeName': 'Domenic', 'Initials': 'D', 'LastName': 'Ciraulo', 'Affiliation': 'Boston University School of Medicine, USA; VA Boston Healthcare System, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2008.06.012']
2666,32432384,Internet-based interpretation bias modification for body dissatisfaction: A three-armed randomized controlled trial.,"OBJECTIVE


Appearance-related interpretation bias is postulated to play a role in the maintenance of body dissatisfaction (BD), a risk factor for body dysmorphic disorder (BDD), and eating disorders (ED). Cognitive bias modification for interpretation (CBM-I) has been shown to reduce maladaptive interpretation bias and symptoms in various emotional disorders. This study investigated the acceptability and efficacy of an easily disseminable, web-based CBM-I program for BD.
METHODS


Individuals with high BD (N = 318) were randomized to a multi-session CBM-I (Sentence Word Association Paradigm [SWAP] with feedback) vs. control (SWAP without feedback) versus waitlist condition. Interpretation bias, BD and associated symptoms were assessed at baseline and post-intervention. Symptoms were monitored up to 1-week and 4-week follow-up. We further investigated transference effects to stress reactivity, as predicted by cognitive-behavioral models, at post-intervention.
RESULTS


Appearance-related CBM-I led to a differential pre-post increase in adaptive interpretation patterns, particularly for appearance-related and social situations (d = 0.65-1.18). Both CBM-I and control training reduced BD, BDD symptom severity, and depression. However, CBM-I (vs. control and waitlist) improved appearance-related quality of life (d = 0.51), self-esteem (d = 0.52), and maladaptive appearance-related beliefs (d = 0.47). State stress reactivity was overall reduced in the CBM-I condition (vs. waitlist). Intervention effects largely held stable up to follow-ups. Treatment satisfaction was comparable to other CBM-I studies, with low rates of adverse reactions.
DISCUSSION


These findings support assumptions of cognitive-behavioral models for BD, BDD, and ED, and suggest that web-based CBM-I is an efficacious and acceptable intervention option.",2020,"Appearance-related CBM-I led to a differential pre-post increase in adaptive interpretation patterns, particularly for appearance-related and social situations (d = 0.65-1.18).",['Individuals with high BD (N = 318'],"['multi-session CBM-I (Sentence Word Association Paradigm [SWAP] with feedback) vs. control (SWAP without feedback) versus waitlist condition', 'Internet-based interpretation bias modification']","['BD, BDD symptom severity, and depression', 'State stress reactivity', 'Treatment satisfaction', 'maladaptive appearance-related beliefs', 'self-esteem', 'acceptability and efficacy', 'appearance-related quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0005887', 'cui_str': 'Body dysmorphic disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",318.0,0.0516419,"Appearance-related CBM-I led to a differential pre-post increase in adaptive interpretation patterns, particularly for appearance-related and social situations (d = 0.65-1.18).","[{'ForeName': 'Fanny Alexandra', 'Initials': 'FA', 'LastName': 'Dietel', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Zache', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}, {'ForeName': 'Paul-Christian', 'Initials': 'PC', 'LastName': 'Bürkner', 'Affiliation': 'Department of Computer Science, Aalto University, Espoo, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schulte', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Möbius', 'Affiliation': 'Behavioral Science Institute, Radboud University Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Bischof', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wilhelm', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Buhlmann', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}]",The International journal of eating disorders,['10.1002/eat.23280']
2667,32432411,Treatment With Mycophenolate and Cyclophosphamide Leads to Clinically Meaningful Improvements in Patient-Reported Outcomes in Scleroderma Lung Disease: Results of Scleroderma Lung Study II.,"OBJECTIVE


Our objective was to determine if treatment with cyclophosphamide (CYC) and mycophenolate mofetil (MMF) improves patient-reported outcomes (PROs) among patients with systemic sclerosis-related interstitial lung disease (SSc-ILD).
METHODS


This study examined PROs in patients with SSc-ILD (N = 142) who participated in the Scleroderma Lung Study II, a randomized controlled trial comparing MMF for 2 years with oral CYC for 1 year followed by 1 year of a placebo. Joint models were created to evaluate the course of PROs over 2 years. The difference in PRO scores from baseline to 24 months was measured, and the percentage of patients meeting the minimum clinically important difference (MCID) was calculated. Correlations between PROs and SSc-ILD disease severity measures were also examined.
RESULTS


Treatment with CYC and MMF led to improvements in several PROs with no between-treatment differences. Scores for the Transitional Dyspnea Index (TDI) and St. George's Respiratory Questionnaire (SGRQ) improved significantly over 2 years, and 29%/24% and 28%/25% of participants in the CYC/MMF groups met or exceeded the MCID estimates for TDI and SGRQ, respectively. At baseline, the forced vital capacity (FVC) percentage predicted (FVC%-predicted) did not correlate with the Baseline Dyspnea Index or SGRQ. However, improvements in the FVC%-predicted were weakly associated with improvements in dyspnea (assessed by the TDI) and SGRQ scores.
CONCLUSION


Treatment with CYC and MMF improved overall health-related quality of life in patients with SSc-ILD. The relationship between PRO measures and the FVC was relatively weak, suggesting that PROs provide complementary information about treatment efficacy not captured by changes in the FVC alone in this patient population.",2020,"At baseline, the forced vital capacity (FVC) percentage predicted (FVC%-predicted) did not correlate with the Baseline Dyspnea Index or SGRQ.","['patients with SSc-ILD', 'patients with SSc-ILD (N = 142) who participated in the Scleroderma Lung Study II', 'patients with systemic sclerosis-related interstitial lung disease (SSc-ILD']","['oral CYC', 'Mycophenolate and Cyclophosphamide', 'cyclophosphamide (CYC) and mycophenolate mofetil (MMF', 'CYC and MMF', 'MMF', 'placebo']","['overall health-related quality of life', 'dyspnea (assessed by the TDI) and SGRQ scores', 'several PROs', 'PRO scores', ""Transitional Dyspnea Index (TDI) and St. George's Respiratory Questionnaire (SGRQ"", 'Baseline Dyspnea Index or SGRQ', 'forced vital capacity (FVC) percentage predicted (FVC%-predicted']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0442732', 'cui_str': 'Vital'}]",142.0,0.0648355,"At baseline, the forced vital capacity (FVC) percentage predicted (FVC%-predicted) did not correlate with the Baseline Dyspnea Index or SGRQ.","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'LeClair', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roth', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Clements', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'University of California, Los Angeles, University of Washington, Seattle, and University of Florence, Florence, Italy.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'University of Michigan Medical School, Ann Arbor.'}]",ACR open rheumatology,['10.1002/acr2.11125']
2668,32432795,"The Effect of Mindfulness-Based Training on Stress, Anxiety, Depression, and Job Satisfaction Among Ward Nurses: A Randomized Control Trial.","AIM


To assess the effect of a 4-week Mindfulness-Based Training intervention on improving stress, anxiety, depression, and job satisfaction among ward nurses.
BACKGROUND


Previous literature showed that mindfulness training is useful for helping nurses cope with stress.
METHOD


Nurses who have mild to moderate levels of stress, anxiety, and depression identified from a teaching hospital were invited to a randomized control trial. The intervention group had a 2-hour Mindfulness-Based Training workshop, followed by 4 weeks of guided self-practice Mindfulness-Based Training website. Both the intervention group (n=118) and the control group (n=106) were evaluated pre- and post-intervention, and 8 weeks later (follow-up) using the Depression, Anxiety, and Stress Scale-21, Job Satisfaction Scale, and Mindful Attention Awareness Scale.
RESULTS


There was a significant effect over time on stress, anxiety, depression and mindful level (p˂.05). Regarding the difference between the groups and interaction between time and group, there was a significant effect for anxiety (p=.037 p=.008) and job satisfaction (p˂.001, p=0,40) respectively, with moderate effect size for anxiety reduction (0.465) and small for job satisfaction increment (0.221).
CONCLUSION


Mindfulness-Based Training is effective in improving anxiety and job satisfaction among nurses.
CLINICAL IMPLICATIONS FOR NURSING MANAGEMENT


Mindfulness-Based Training can be included as hospital policy to reduce anxiety and increase job satisfaction among nurses.",2020,"There was a significant effect over time on stress, anxiety, depression and mindful level (p˂.05).","['Nurses who have mild to moderate levels of stress, anxiety, and depression identified from a teaching hospital', 'Among Ward Nurses']","['Mindfulness-Based Training', '4-week Mindfulness-Based Training intervention', '2-hour Mindfulness-Based Training workshop, followed by 4 weeks of guided self-practice Mindfulness-Based Training website', 'mindfulness training']","['stress, anxiety, depression and mindful level (p˂.05', 'anxiety', 'anxiety and job satisfaction', 'Stress, Anxiety, Depression, and Job Satisfaction', 'anxiety reduction', 'Depression, Anxiety, and Stress Scale-21, Job Satisfaction Scale, and Mindful Attention Awareness Scale', 'job satisfaction', 'stress, anxiety, depression, and job satisfaction']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",,0.0175315,"There was a significant effect over time on stress, anxiety, depression and mindful level (p˂.05).","[{'ForeName': 'Sajed Faisal', 'Initials': 'SF', 'LastName': 'Ghawadra', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Khatijah', 'Initials': 'K', 'LastName': 'Lim Abdullah', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Wan Yuen', 'Initials': 'WY', 'LastName': 'Choo', 'Affiliation': 'Department of Social & Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Danaee', 'Affiliation': 'Department of Social & Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Cheng Kar', 'Initials': 'CK', 'LastName': 'Phang', 'Affiliation': 'Sunway Medical Centre, and President of Malaysia Association for Mindfulness Practice & Research (MMPR), Kuala Lumpur, Malaysia.'}]",Journal of nursing management,['10.1111/jonm.13049']
2669,32432487,Which Mothers Know That All Babies Cry? A Randomized Controlled Trial of a Child Abuse Prevention Program for Low-Income New Mothers.,"This study evaluated an intervention for low-income new mothers, half from Spanish-speaking homes, that provides education around infant crying and abusive head trauma (AHT). At enrollment, non-US-born mothers were less likely than US-born mothers to have heard of shaken baby syndrome (60% vs 89%,  P  ≤ .0001) or to know shaking babies could lead to brain damage or death (48% vs 80%,  P  < .0001). At follow-up, non-US-born intervention mothers had improved knowledge of the peak of crying (31% vs 4%,  P  = .009), improved knowledge that shaking a baby could lead to brain damage or death (36% vs 12%,  P  = .035), and identified more calming strategies for parenting stress compared with non-US-born control mothers (+0.8 [SD = 1.1] vs -0.4 [SD = 1.4]). This study identifies a gap in AHT knowledge at baseline of non-US-born mothers. These mothers had improved knowledge with intervention and are an important population for similar prevention efforts.",2020,"At enrollment, non-US-born mothers were less likely than US-born mothers to have heard of shaken baby syndrome (60% vs 89%,  P  ≤ .0001) or to know shaking babies could lead to brain damage or death (48% vs 80%,  P  < .0001).","['Low-Income New Mothers', 'non-US-born mothers', 'low-income new mothers, half from Spanish-speaking homes, that provides education around infant crying and abusive head trauma (AHT']",['Child Abuse Prevention Program'],"['brain damage or death', 'heard of shaken baby syndrome', 'knowledge of the peak of crying']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0581876', 'cui_str': 'Crying infant'}, {'cui': 'C0018674', 'cui_str': 'Injury of head'}]","[{'cui': 'C1261559', 'cui_str': 'Child abuse prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0686721', 'cui_str': 'Shaken baby syndrome'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010399', 'cui_str': 'Crying'}]",,0.0492089,"At enrollment, non-US-born mothers were less likely than US-born mothers to have heard of shaken baby syndrome (60% vs 89%,  P  ≤ .0001) or to know shaking babies could lead to brain damage or death (48% vs 80%,  P  < .0001).","[{'ForeName': 'Luisa F', 'Initials': 'LF', 'LastName': 'Cala Cala', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Carrie Leah', 'Initials': 'CL', 'LastName': 'Kelly', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Elaina', 'Initials': 'E', 'LastName': 'Ramos', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'VanVleet', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'High', 'Affiliation': 'Brown University, Providence, RI, USA.'}]",Clinical pediatrics,['10.1177/0009922820922532']
2670,32432491,Prospective Randomized Study Examining Preoperative Opioid Counseling on Postoperative Opioid Consumption after Upper Extremity Surgery.,"Background:  Rates of opioid addiction and overdose continue to climb in the United States, increasing pressure on prescribers to identify solutions to decrease postoperative opioid consumption. Hand and upper extremity surgeries are high-volume surgeries with a predilection for inadvertent overprescribing. Recent investigations have shown that preoperative opioid counseling may decrease postoperative opioid consumption. In order to test this hypothesis, a prospective randomized trial was undertaken to determine the effect of preoperative opioid counseling on postoperative opioid consumption.  Methods:  Eligible patients undergoing outpatient upper extremity surgery were randomized to either receive preoperative opioid counseling or to receive no counseling. Surgeons were blinded to their patient's counseling status. Preoperatively, patient demographics, surgical and prescription details were recorded. Postoperatively, patients' pain experience including opioid consumption, pain levels, and satisfaction was recorded.  Results:  There were 131 total patients enrolled, with 62 in the counseling group and 69 in the control group. Patients receiving counseling consumed 11.8 pills compared to 17.4 pills in the control group ( P  = .007), which translated to 93.7 Morphine Equivalent Units (MEU) in the counseling group compared to 143.2 MEU in the control group ( P  = .01). There was no difference in pain scores at any time point between groups. Among all study patients a total of 3767 opioid pills were prescribed with approximately 50% left unused.  Conclusion:  Patients receiving preoperative counseling consumed significantly fewer opioids postoperatively. Inadvertant overprescribing remains high. Routine use of preoperative counseling should be implemented along with prescribing fewer opioids overall to prevent overprescribing.",2020,"Patients receiving counseling consumed 11.8 pills compared to 17.4 pills in the control group ( P  = .007), which translated to 93.7 Morphine Equivalent Units (MEU) in the counseling group compared to 143.2 MEU in the control group ( P  = .01).","['Eligible patients undergoing outpatient upper extremity surgery', 'after Upper Extremity Surgery', 'Among all study patients a total of 3767 opioid pills were prescribed with approximately 50% left unused', '131 total patients enrolled, with 62 in the counseling group and 69 in the control group']","['Preoperative Opioid Counseling', 'preoperative opioid counseling', 'preoperative opioid counseling or to receive no counseling']","['opioid consumption, pain levels, and satisfaction', 'postoperative opioid consumption', 'Postoperative Opioid Consumption', 'pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0237547', 'cui_str': 'Group counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",3767.0,0.0538071,"Patients receiving counseling consumed 11.8 pills compared to 17.4 pills in the control group ( P  = .007), which translated to 93.7 Morphine Equivalent Units (MEU) in the counseling group compared to 143.2 MEU in the control group ( P  = .01).","[{'ForeName': 'Sage', 'Initials': 'S', 'LastName': 'Vincent', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Paskey', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Critchlow', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Mann', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Chapman', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Abboudi', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kirkpatrick', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Surena', 'Initials': 'S', 'LastName': 'Namdari', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Sommer', 'Initials': 'S', 'LastName': 'Hammoud', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Asif M', 'Initials': 'AM', 'LastName': 'Ilyas', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}]","Hand (New York, N.Y.)",['10.1177/1558944720919936']
2671,32432695,Coached Mobile App Platform for the Treatment of Depression and Anxiety Among Primary Care Patients: A Randomized Clinical Trial.,"Importance


Depression and anxiety are common and disabling. Primary care is the de facto site for treating these mental health problems but is typically underresourced to meet the burden of these demands.
Objective


To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
Design, Setting, and Participants


Two-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences. Adult primary care patients (N = 146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score  ≥ 10) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score ≥ 8) were recruited between July 17, 2018, and December 14, 2018.
Interventions


The coach-supported platform composed of a suite of apps, was delivered over 8 weeks. Wait list control participants received treatment as usual for 8 weeks, then the mobile platform.
Main Outcomes and Measures


Primary outcomes were changes in depression (PHQ-9) and anxiety (GAD-7) during the intervention period. Secondary outcomes were differences in the proportion of patients who achieved recovery (PHQ-9/GAD-7 <5 or 50% improvement from baseline), sustainment of intervention effects during 2-month follow-up, and app use during the intervention period.
Results


One hundred forty-six patients were included (119 of 146 were women [81.5%]; mean [SD] age, 42.3 [13.8] years). Of the 146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety. A greater proportion of intervention vs wait list control participants achieved recovery from depression (n = 38 of 64 [59%] vs n = 18 of 58 [31%]; odds ratio, 3.25; 95% CI, 1.54-6.86) and anxiety (n = 37 of 65 [57%] vs n = 25 of 66 [38%]; odds ratio, 2.17; 95% CI, 1.08-4.36). Sustained effects were observed for depression (slope, 0.01; 95% CI, -0.09 to 0.10; P = .92) and anxiety scores (slope, 0.02; 95% CI, -0.08 to 0.12; P = .67) during follow-up. App use was high, with a median of 93 and 98 sessions among participants with depression and anxiety, respectively.
Conclusions and Relevance


In this trial, a mobile intervention app was effective for depression and anxiety among primary care patients. Findings also support designing digital mental health interventions as platforms containing simple, brief apps that can be bundled by users to meet their needs.
Trial Registration


ClinicalTrials.gov Identifier: NCT03500536.",2020,"To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
","['Adult primary care patients (N\u2009=\u2009146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score \u2009≥\u200910) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score\u2009≥\u20098) were recruited between July 17, 2018, and December 14, 2018', 'Primary Care Patients', '146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety', 'One hundred forty-six patients were included (119 of 146 were women [81.5', 'Participants\n\n\nTwo-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences', 'primary care patients']","['mobile intervention platform, IntelliCare', 'Coached Mobile App Platform']","['proportion of patients who achieved recovery (PHQ-9/GAD-7', 'anxiety', 'changes in depression (PHQ-9) and anxiety (GAD-7', 'anxiety scores', 'depression and anxiety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3838887', 'cui_str': 'Internal medicine clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",146.0,0.149203,"To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
","[{'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Graham', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Greene', 'Affiliation': 'Psychiatric Research Institute, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Kaiser', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lieponis', 'Affiliation': 'Actualize Therapy, Inc, Chicago, Illinois.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powell', 'Affiliation': 'Department of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1011']
2672,31925817,"First-in-human clinical trial to assess the safety, tolerability and pharmacokinetics of P218, a novel candidate for malaria chemoprotection.","AIMS


This first-in-human clinical trial of P218, a novel dihydrofolate reductase inhibitor antimalarial candidate, assessed safety, tolerability, pharmacokinetics and food effects in healthy subjects.
METHODS


The study consisted of two parts. Part A was a double-blind, randomized, placebo-controlled, parallel group, ascending dose study comprising seven fasted cohorts. Eight subjects/cohort were randomized (3:1) to receive either a single oral dose of P218 (10, 30, 100, 250, 500, 750 and 1000 mg) or placebo. Part B was an open-label, cross-over, fed/fasted cohort (eight subjects) that received a 250 mg single dose of P218 in two treatment periods.
RESULTS


P218 was generally well tolerated across all doses; 21 treatment-emergent adverse events occurred in 15/64 subjects. Nine adverse events in five subjects, all of mild intensity, were judged drug related. No clinically relevant abnormalities in ECG, vital signs or laboratory tests changes were observed. P218 was rapidly absorbed, with C max  achieved between 0.5 and 2 hours post dose. Plasma concentrations declined bi-exponentially with half-life values ranging from 3.1 to 6.7 hours (10 and 30 mg), increasing up to 8.9 to 19.6 hours (doses up to 1000 mg). Exposure values increased dose-proportionally between 100 and 1000 mg for P218 (parent) and three primary metabolites (P218 β-acyl glucuronide, P218-OH and P218-OH β-acyl glucuronide). Co-administration of P218 with food reduced C max  by 35% and delayed absorption by 1 hour, with no significant impact on AUC.
CONCLUSION


P218 displayed favourable safety, tolerability and pharmacokinetics. In view of its short half-life, a long-acting formulation will be needed for malaria chemoprotection.",2020,"RESULTS


P218 was generally well tolerated across all doses; 21 treatment-emergent adverse events occurred in 15/64 subjects.",['healthy subjects'],"['placebo', 'Co']","['Plasma concentrations', 'safety, tolerability, pharmacokinetics and food effect', 'delayed absorption', 'safety, tolerability and pharmacokinetics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}]",8.0,0.0945555,"RESULTS


P218 was generally well tolerated across all doses; 21 treatment-emergent adverse events occurred in 15/64 subjects.","[{'ForeName': 'M Farouk', 'Initials': 'MF', 'LastName': 'Chughlay', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Rossignol', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Donini', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'El Gaaloul', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lorch', 'Affiliation': 'Richmond Pharmacology Ltd, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Coates', 'Affiliation': 'Richmond Pharmacology Ltd, London, UK.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Langdon', 'Affiliation': 'PTx Solutions, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hammond', 'Affiliation': 'Preclinical Safety Consulting Ltd, Loughborough, Leicestershire, UK.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Möhrle', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Chalon', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.14219']
2673,32432553,Midwives' Attitudes Toward and Experience With a Tablet Intervention to Promote Safety Behaviors for Pregnant Women Reporting Intimate Partner Violence: Qualitative Study.,"BACKGROUND


Violence against women is considered a global health problem, and intimate partner violence (IPV) around the time of childbirth can have severe consequences for mother and child. Prenatal care is considered a window of opportunity to address IPV and ask women about exposure to violence since women are in regular contact with health care providers. Mobile health (mHealth) interventions might overcome the barriers to talking about IPV face-to-face.
OBJECTIVE


Our objective was to explore midwives' attitudes toward a tablet intervention consisting of information about IPV and safety behaviors as well as their experiences with recruiting pregnant women of different ethnic backgrounds in a randomized controlled trial (RCT).
METHODS


Individual interviews were conducted with 9 midwives who recruited participants for an RCT to test a video to promote safety behaviors delivered on a tablet during prenatal care. Analysis was guided by thematic analysis.
RESULTS


Midwives perceived the tablet intervention as an appropriate supplement during prenatal care to provide information about IPV and promote safety behaviors. They participated in the RCT primarily to obtain more knowledge regarding how to communicate about IPV. The intervention was perceived as an anonymous door-opener to talk about IPV and a good solution to ensure that every woman gets the same information. However, the content of the intervention had to be trustworthy and align with the information the midwives provide to women. Given the sensitivity of IPV, midwives outlined the importance of following the intervention with face-to-face communication. Midwives reported technical problems and a high demand on their time as the main challenges to recruiting women. They experienced challenges recruiting women of different ethnic backgrounds due to linguistic barriers and the women's skepticism about scientific research.
CONCLUSIONS


The tablet intervention might help midwives communicate about IPV. Although the video was considered as an anonymous door-opener to talk about IPV, midwives outlined the importance of following the intervention with face-to-face communication. The scarcity of midwives' time during consultations has to be considered when implementing the intervention. Further research is needed to overcome barriers that limit inclusion of women from different ethnic backgrounds.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03397277; https://clinicaltrials.gov/ct2/show/NCT03397277.",2020,"RESULTS


Midwives perceived the tablet intervention as an appropriate supplement during prenatal care to provide information about IPV and promote safety behaviors.","['Violence against women', 'Individual interviews were conducted with 9 midwives who recruited participants for an', 'Pregnant Women Reporting Intimate Partner Violence']","['Tablet Intervention', 'RCT to test a video to promote safety behaviors delivered on a tablet during prenatal care', 'Mobile health (mHealth) interventions']",[],"[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]",[],9.0,0.0527447,"RESULTS


Midwives perceived the tablet intervention as an appropriate supplement during prenatal care to provide information about IPV and promote safety behaviors.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Garnweidner-Holme', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Henriksen', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Eva Marie', 'Initials': 'EM', 'LastName': 'Flaathen', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Klette Bøhler', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Lukasse', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}]",JMIR mHealth and uHealth,['10.2196/16828']
2674,32432684,Efficacy of Evolocumab on Cardiovascular Outcomes in Patients With Recent Myocardial Infarction: A Prespecified Secondary Analysis From the FOURIER Trial.,"Importance


The 2018 American Heart Association/American College of Cardiology Multisociety Guideline on the Management of Blood Cholesterol identified patients with recent (past 12 months) myocardial infarction (MI) as very high risk, in whom a PCSK9 inhibitor is reasonable to add to maximally tolerated statin combined with ezetimibe if their low-density lipoprotein cholesterol level is 70 mg/dL or greater or non-high-density lipoprotein cholesterol level is 100 mg/dL or greater.
Objective


To examine the clinical efficacy of evolocumab in patients with recent MI.
Design, Setting, and Participants


This was a prespecified secondary analysis of the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, in which 27 564 patients with atherosclerotic cardiovascular disease treated with a statin were randomized to evolocumab vs placebo. Patients with prior MI with a known date (n = 22 320) were stratified as having a recent MI (within 12 months of randomization) or a remote MI (more than 12 months prior to randomization). Per protocol, patients with MI within 4 weeks prior to randomization were excluded from the FOURIER trial. Data were collected from February 2013 to November 2016, and data were analyzed from May 2019 to February 2020.
Main Outcomes and Measures


The primary composite end point was cardiovascular death, MI, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary composite end point was cardiovascular death, MI, or stroke.
Results


Of 22 320 included patients, 17 516 (78.5%) were male, and the mean (SD) age was 62.2 (9.0) years. Compared with 16 609 patients with a remote MI, 5711 patients with a recent MI were younger and more likely to be treated with high-intensity statin (77.3% [4415] vs 69.3% [11 506]). In the placebo arm, the 3-year Kaplan-Meier rate for the primary end point was 17.2% in patients with recent MI compared with 14.4% in those with remote MI (adjusted HR, 1.45; 95% CI, 1.29-1.64; P < .001). Similarly, the 3-year Kaplan-Meier rates for the key secondary end point was also higher in those with recent MI (10.9% vs 9.5%; adjusted HR, 1.45; 95% CI, 1.24-1.69; P < .001). In patients with a recent MI, evolocumab reduced the risk of the primary and key secondary end points by 19% (hazard ratio [HR], 0.81; 95% CI, 0.70-0.93) and 25% (HR, 0.75; 95% CI, 0.62-0.91), respectively. In patients with a remote MI, evolocumab reduced the risk of the primary and key secondary end points by 8% (HR, 0.92; 95% CI, 0.84-1.01; P for interaction = .13) and 15% (HR, 0.85; 95% CI, 0.76-0.96; P for interaction = .24), respectively. Given the higher event rates in patients with a recent MI, the absolute risk reductions over 3 years with evolocumab were 3.7% in those with recent MI vs 1.1% in those with remote MI for the primary end point and 3.2% vs 1.3%, respectively, for the key secondary end point.
Conclusions and Relevance


Patients with a recent MI were at higher risk of cardiovascular events and tended to experience greater absolute risk reductions with evolocumab than those with remote MIs. These findings support the concept in US and European guidelines to aggressively lower low-density lipoprotein cholesterol levels in very high-risk patients, such as those with a recent MI.
Trial Registration


ClinicalTrials.gov Identifier: NCT01764633.",2020,"In the placebo arm, the 3-year Kaplan-Meier rate for the primary end point was 17.2% in patients with recent MI compared with 14.4% in those with remote MI (adjusted HR, 1.45; 95% CI, 1.29-1.64; P < .001).","['Subjects With Elevated Risk (FOURIER) trial, in which 27 564 patients with atherosclerotic cardiovascular disease treated with a statin', 'Patients With Recent Myocardial Infarction', 'Patients with prior MI with a known date (n\u2009=\u200922\u202f320', 'Data were collected from February 2013 to November 2016, and data were analyzed from May 2019 to February 2020', '2018 American Heart Association/American College of Cardiology Multisociety Guideline on the Management of Blood Cholesterol identified patients with recent (past 12 months) myocardial infarction (MI', 'Results\n\n\nOf 22\u202f320 included patients, 17\u202f516 (78.5%) were male, and the mean (SD) age was 62.2 (9.0) years', 'patients with recent MI']","['placebo', 'Evolocumab', 'evolocumab', 'evolocumab vs placebo']","['low-density lipoprotein cholesterol levels', '3-year Kaplan-Meier rates', 'cardiovascular death, MI, or stroke', 'cardiovascular death, MI, stroke, hospitalization for unstable angina, or coronary revascularization', '3-year Kaplan-Meier rate', 'absolute risk reductions', 'Cardiovascular Outcomes', 'cardiovascular events']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C1426592', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 gene'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",27564.0,0.152673,"In the placebo arm, the 3-year Kaplan-Meier rate for the primary end point was 17.2% in patients with recent MI compared with 14.4% in those with remote MI (adjusted HR, 1.45; 95% CI, 1.29-1.64; P < .001).","[{'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Gencer', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Mach', 'Affiliation': 'Cardiology Division, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Gaetano M', 'Initials': 'GM', 'LastName': 'De Ferrari', 'Affiliation': 'Division of Cardiology Città della Salute e della Scienza, Department of Medical Sciences, University of Torino, Turin, Italy.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Department of Medicine, Cardiology and Intensive Care Medicine and Sigmund Freud University, Medical School, Vienna, Austria.'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Lady Davis Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Ferreira', 'Affiliation': 'Hospital de Santa Cruz, Lisbon, Portugal.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kurtz', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Huei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Narimon', 'Initials': 'N', 'LastName': 'Honarpour', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'Sydney Medical School, National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sever', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Terje R', 'Initials': 'TR', 'LastName': 'Pedersen', 'Affiliation': 'Oslo University Hospital, Ulleval and Medical Faculty, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2020.0882']
2675,32432448,Game-based vs mulitaleral approach: effects of a 12-week program on motor skill acquisition and physical fitness development in soccer school children.,"BACKGROUND


The purpose of this study was to investigate the effects of a 12-week- game-based training versus a traditional multilateral approach on motor skills acquisition and physical fitness, in a group of U9 children playing soccer.
METHODS


40 Children 9 years old or younger (U9) recruited from a local soccer school were assigned in a 1:1 ratio to a game-based training program (GB) or a multilateral training (MA) approach. The training programs lasted 12 weeks, and players were tested at baseline and at the end of the program (12-week follow-up). The outcomes were: standing long jump test, shuttle dribble test, 10x5 shuttle run test and Mini-Cooper test.
RESULTS


Within-group comparisons showed statistically-significant improvements in both of the groups: standing long lump (p < 0.0001), shuttle dribble test (p < 0.0001), shuttle run test (p < 0.0001) and Mini-Cooper test (p < 0.0001). Furthermore, the MA group showed better performance in the shuttle run test after 12 weeks of training compared to the GB group (p= 0.0002; +8%).
CONCLUSIONS


A multilateral approach promotes physical development in U9 soccer players without affecting learning of soccer skills. Therefore, a multilateral approach should be included in soccer training programs to ensure an optimal development in young soccer players.",2020,"Furthermore, the MA group showed better performance in the shuttle run test after 12 weeks of training compared to the GB group (p= 0.0002; +8%).
","['U9 soccer players without affecting learning of soccer skills', '40 Children 9 years old or younger (U9) recruited from a local soccer school', 'soccer school children', 'young soccer players', 'U9 children playing soccer']","['12-week- game-based training versus a traditional multilateral approach', 'game-based training program (GB) or a multilateral training (MA) approach']","['shuttle dribble test', 'motor skill acquisition and physical fitness development', 'motor skills acquisition and physical fitness', 'standing long jump test, shuttle dribble test, 10x5 shuttle run test and Mini-Cooper test', 'standing long lump']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0335912', 'cui_str': 'Cooper'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",40.0,0.020152,"Furthermore, the MA group showed better performance in the shuttle run test after 12 weeks of training compared to the GB group (p= 0.0002; +8%).
","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Abate Daga', 'Affiliation': 'Department of Medical Sciences, University of Turin, Turin, Italy - federico.abatedaga@unito.it.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Baseggio', 'Affiliation': 'Adapted Training and Performance Research Group, School of Exercise and Sport Sciences, Department of Medical Sciences University of Turin, Turin, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Gollin', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Beratto', 'Affiliation': 'Adapted Training and Performance Research Group, School of Exercise and Sport Sciences, Department of Medical Sciences University of Turin, Turin, Italy.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10726-6']
2676,32432550,A Brief Music App to Address Pain in the Emergency Department: Prospective Study.,"BACKGROUND


Emergency physicians face the challenge of relieving acute pain daily. While opioids are a potent treatment for pain, the opioid epidemic has ignited a search for nonopioid analgesic alternatives that may decrease the dose or duration of opioid exposure. While behavioral therapies and complementary medicine are effective, they are difficult to deploy in the emergency department. Music is a potential adjunctive therapy that has demonstrated effectiveness in managing pain.
OBJECTIVE


Our objective was to understand the feasibility and potential for an effect of a novel music app to address acute pain and anxiety in patients admitted to an emergency department observation unit.
METHODS


This prospective cohort study enrolled patients admitted to an emergency department observation unit with pain who had received orders for opioids. We gathered baseline pain and psychosocial characteristics including anxiety, sleep disturbance, and pain catastrophizing using validated questionnaires. Participants received a smartphone-based music intervention and listened to the music in either a supervised (research assistant-delivered music session 3 times during their stay) or unsupervised manner (music used ad lib by participant). The app collected premusic and postmusic pain and anxiety scores, and participants provided qualitative feedback regarding acceptability of operating the music intervention.
RESULTS


We enrolled 81 participants and randomly assigned 38 to an unsupervised and 43 to a supervised group. Mean pain in both groups was 6.1 (1.8) out of a possible score of 10. A total of 43 (53%) reported previous use of music apps at home. We observed an overall modest but significant decrease in pain (mean difference -0.81, 95% CI -0.45 to -1.16) and anxiety (mean difference -0.72, 95% CI -0.33 to -1.12) after music sessions. Reduction of pain and anxiety varied substantially among participants. Individuals with higher baseline pain, catastrophizing (about pain), or anxiety reported greater relief. Changes in pain were correlated to changes in anxiety (Pearson ρ=0.3, P=.02) but did not vary between supervised and unsupervised groups. Upon conclusion of the study, 46/62 (74%) reported they liked the music intervention, 57/62 (92%) reported the app was easy to use, and 49/62 (79%) reported they would be willing to use the music intervention at home.
CONCLUSIONS


A smartphone-based music intervention decreased pain and anxiety among patients in an emergency department observation unit, with no difference between supervised and unsupervised use. Individuals reporting the greatest reduction in pain after music sessions included those scoring highest on baseline assessment of catastrophic thinking, suggesting there may be specific patient populations that may benefit more from using music as an analgesic adjunct in the emergency department. Qualitative feedback suggested that this intervention was feasible and acceptable by emergency department patients.",2020,"Individuals with higher baseline pain, catastrophizing (about pain), or anxiety reported greater relief.","['Individuals with higher baseline pain, catastrophizing (about pain), or anxiety reported greater relief', 'enrolled patients admitted to an emergency department observation unit with pain who had received orders for opioids', 'patients admitted to an emergency department observation unit']","['smartphone-based music intervention and listened to the music in either a supervised (research assistant-delivered music session 3 times during their stay) or unsupervised manner (music used ad lib by participant', 'smartphone-based music intervention', 'Music App', 'novel music app']","['Changes in pain', 'pain and anxiety', 'anxiety', 'Mean pain', 'pain', 'baseline pain and psychosocial characteristics including anxiety, sleep disturbance, and pain catastrophizing', 'acute pain and anxiety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C4284828', 'cui_str': 'Observation Units'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]",81.0,0.0985102,"Individuals with higher baseline pain, catastrophizing (about pain), or anxiety reported greater relief.","[{'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Chai', 'Affiliation': ""Division of Medical Toxicology, Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Schwartz', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Mohammad Adrian', 'Initials': 'MA', 'LastName': 'Hasdianda', 'Affiliation': ""Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Desiree R', 'Initials': 'DR', 'LastName': 'Azizoddin', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana Farber Cancer Institute, Boston, MA, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kikut', 'Affiliation': ""Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Guruprasad D', 'Initials': 'GD', 'LastName': 'Jambaulikar', 'Affiliation': ""Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Boyer', 'Affiliation': ""Division of Medical Toxicology, Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Schreiber', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}]",Journal of medical Internet research,['10.2196/18537']
2677,32432556,Efficacy of Text Messaging and Personal Consultation by Pharmacy Students Among Adults With Hypertension: Randomized Controlled Trial.,"BACKGROUND


Hypertension is one of the leading risk factors for ischemic heart diseases, and high rates of hypertension prevalence have either remained the same or increased in developing countries in recent years. Unfortunately, about 20% to 50% of patients with chronic diseases have been nonadherent to their drug therapy. SMS text messaging and pharmacy student-led consultations have the potential to help patients manage their blood pressure (BP).
OBJECTIVE


The aim of this study was to assess the effectiveness, feasibility, and acceptability of SMS text messaging and consultation to manage the BP of Chinese patients with hypertension.
METHODS


We conducted a two-arm cluster randomized controlled trial among patients with hypertension in Xi'an City, Shaanxi Province, China, and recruited 384 patients from 8 community health care centers. Patients were randomized into an intervention group to receive SMS text messages and consultations or into a control group to receive usual care for 3 months. We sent SMS text messages at 3-day intervals and collected data at baseline (including demographics, clinical outcomes, medication complexity, side effects, patient behavior, knowledge about hypertension, BP, and medication adherence) and the 3-month follow-up (including BP, medication adherence, and knowledge about hypertension).
RESULTS


We assessed 445 patients with hypertension and excluded 61 patients who were not eligible or who had not filled out their questionnaires. The mean age of the patients was 68.5 (SD 7.9) years in the intervention group and 69.4 (SD 9.7) years in the control group, and the sample was primarily female (265/384, 69.0%). Patients in the intervention group showed significant improvements in systolic BP (SBP; mean 134.5 mm Hg, SD 15.5 mm Hg vs mean 140.7 mm Hg, SD 15.2 mm Hg; P=.001), medication adherence (mean 7.4, SD 1.2 vs mean 7.0, SD 1.3; P=.04), and knowledge about hypertension (mean 6.3, SD 0.9 vs mean 5.9, SD 1.2; P=.004) compared with those in the control group. In measures of diastolic BP (DBP), the two arms showed nonsignificant improvements (mean 78.2 mm Hg, SD 9.0 mm Hg vs mean 77.2 mm Hg, SD 10.3 mm Hg; P=.06). In total, 176 patients had controlled BP at the 3-month follow-up (98 patients in the intervention group vs 78 patients in the control group), but it was nonsignificant (P=.08).
CONCLUSIONS


The use of SMS text messaging and consultation to manage SBP and improve medication adherence is effective, feasible, and acceptable among Chinese patients with hypertension, although a significant difference was not observed with regard to DBP. It is important to maximize the potential of SMS text messaging and consultation by increasing the feasibility and acceptance of mobile interventions and conduct a cost-effectiveness analysis on this method.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1900026862; http://www.chictr.org.cn/showproj.aspx?proj=42717.",2020,"Patients in the intervention group showed significant improvements in systolic BP (SBP; mean 134.5 mm Hg, SD 15.5 mm","['Chinese patients with hypertension', 'mean age of the patients was 68.5 (SD 7.9) years in the intervention group and 69.4 (SD 9.7) years in the control group, and the sample was primarily female (265/384, 69.0', '445 patients with hypertension and excluded 61 patients who were not eligible or who had not filled out their questionnaires', 'Pharmacy Students', ""patients with hypertension in Xi'an City, Shaanxi Province, China, and recruited 384 patients from 8 community health care centers"", 'Adults With Hypertension']","['SMS text messaging and consultation', 'Text Messaging and Personal Consultation', 'SMS text messages and consultations or into a control group to receive usual care for 3 months']","['controlled BP', 'medication adherence', 'diastolic BP (DBP', 'medication complexity, side effects, patient behavior, knowledge about hypertension, BP, and medication adherence) and the 3-month follow-up (including BP, medication adherence, and knowledge about hypertension', 'knowledge about hypertension', 'blood pressure (BP', 'effectiveness, feasibility, and acceptability', 'systolic BP (SBP']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0086034', 'cui_str': 'Community Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",445.0,0.126857,"Patients in the intervention group showed significant improvements in systolic BP (SBP; mean 134.5 mm Hg, SD 15.5 mm","[{'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Zhai', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Khezar', 'Initials': 'K', 'LastName': 'Hayat', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Ji', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Naveel', 'Initials': 'N', 'LastName': 'Atif', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Pengchao', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Du', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""Department of Pharmacy Administration and Clinical Pharmacy, Xi'an Jiaotong University, Xi'an, China.""}]",Journal of medical Internet research,['10.2196/16019']
2678,32427541,Comparison of Instructor-Provided Versus Student-Generated Graphic Organizers in an Elective Veterinary Cardiology Course.,"Graphic organizers (GOs) are visual and spatial displays that facilitate learning by making conceptual relationships between content more apparent. It remains unknown whether GOs are more effective when completed by the teacher (instructor-provided [IP]) versus the learner (student-generated [SG]). A mixed-methods prospective randomized crossover trial was undertaken with veterinary students ( n  = 60) in an elective cardiology course. All students received identical content presented via weekly in-class lectures and were subsequently given study aids in either IP or SG format. One week later, students completed quizzes of content knowledge for each lesson and indicated amount of time spent studying. Crossover occurred such that groups of students alternated between receiving IP and SG. Quantitative and qualitative data were collected in the form of in-depth pre- and post-course surveys. Overall, there was no significant difference in quiz scores based on study aid type ( p  = .06). Students spent an average of 25% less time studying per lesson when using IP GOs compared with SG GOs ( p  < .001). Time spent studying for each quiz, as well as time period between date of studying and date of quiz, decreased significantly throughout the semester. Overall, students strongly preferred IP to SG format ( p  < .001); reasons listed included confidence in accuracy and completeness of information, as well as increased study efficiency. In an elective veterinary cardiology course, use of IP compared to SG format study aids resulted in higher study efficiency and student satisfaction with equivalent short-term learning outcomes.",2020,"Overall, students strongly preferred IP to SG format ( p  < .001); reasons listed included confidence in accuracy and completeness of information, as well as increased study efficiency.",['veterinary students ( n  = 60) in an elective cardiology course'],['Instructor-Provided Versus Student-Generated Graphic Organizers'],"['time studying per lesson', 'quiz scores', 'study efficiency and student satisfaction']","[{'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0040227', 'cui_str': 'Time Studies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0217695,"Overall, students strongly preferred IP to SG format ( p  < .001); reasons listed included confidence in accuracy and completeness of information, as well as increased study efficiency.","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ward', 'Affiliation': ''}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Vengrin', 'Affiliation': ''}]",Journal of veterinary medical education,['10.3138/jvme.1018-121r1']
2679,32432798,Clearance of head and neck involvement in plaque psoriasis with tildrakizumab treatment in the phase 3 reSURFACE 1 study.,"Scalp, face, and neck involvement in psoriasis negatively impacts patient quality of life. 1-3  In the phase 3 double-blind, randomised, placebo-controlled reSURFACE 1 trial (NCT01722331), Psoriasis Area and Severity Index (PASI) response rates in patients with moderate to severe plaque psoriasis were high and durable following treatment with interleukin (IL)-23p19 inhibitor tildrakizumab, with acceptable safety. 4 .",2020,"In the phase 3 double-blind, randomised, placebo-controlled reSURFACE 1 trial (NCT01722331), Psoriasis Area and Severity Index (PASI) response rates in patients with moderate to severe plaque psoriasis were high and durable following treatment with interleukin (IL)-23p19 inhibitor tildrakizumab, with acceptable safety.",['patients with moderate to severe plaque psoriasis'],"['tildrakizumab', 'interleukin (IL)-23p19 inhibitor tildrakizumab', 'placebo']",['Psoriasis Area and Severity Index (PASI) response rates'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.129196,"In the phase 3 double-blind, randomised, placebo-controlled reSURFACE 1 trial (NCT01722331), Psoriasis Area and Severity Index (PASI) response rates in patients with moderate to severe plaque psoriasis were high and durable following treatment with interleukin (IL)-23p19 inhibitor tildrakizumab, with acceptable safety.","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Menter', 'Affiliation': 'Division of Dermatology, Baylor Scott & White, and Texas A&M College of Medicine, Dallas, TX, USA.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Murakawa', 'Affiliation': 'Somerset Skin Centre, Troy, MI, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Glover', 'Affiliation': 'Dermatology and Skin Cancer Surgery Center, McKinney, TX, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Mendelsohn', 'Affiliation': 'Sun Pharmaceutical Industries, Inc, Princeton, NJ, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parno', 'Affiliation': 'Sun Pharmaceutical Industries, Inc, Princeton, NJ, USA.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Rozzo', 'Affiliation': 'Sun Pharmaceutical Industries, Inc, Princeton, NJ, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Davidson', 'Affiliation': 'Sun Pharmaceutical Industries, Inc, Princeton, NJ, USA.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Division of Dermatology, Department of Medicine, University of Toronto School of Medicine, Toronto, ON, Canada.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16648']
2680,32432718,Sex-Based Outcomes in Patients With a High Bleeding Risk After Percutaneous Coronary Intervention and 1-Month Dual Antiplatelet Therapy: A Secondary Analysis of the LEADERS FREE Randomized Clinical Trial.,"Importance


Female sex has been identified as a risk factor for bleeding after percutaneous coronary intervention (PCI) and may have contributed to the underuse of drug-eluting stents in women. This risk may be further enhanced among patients with a high bleeding risk.
Objective


To assess the 2-year outcomes by sex in patients with a high bleeding risk who were enrolled in the LEADERS FREE trial.
Design, Setting, and Participants


This cohort study is a prespecified, sex-based secondary analysis of the LEADERS FREE double-blind, randomized clinical trial that was conducted at 68 sites in 20 countries from December 2012 to May 2014. Patients with a high bleeding risk who underwent PCI and met the trial eligibility criteria were enrolled at the participating sites and followed up for up to 2 years.
Interventions


Patients were randomized 1:1 to either a bare-metal stent or a polymer-free, biolimus A9-eluting drug-coated stent with 1-month of dual antiplatelet therapy.
Main Outcomes and Measures


The primary safety end point was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target lesion revascularization. Bleeding was assessed using the Bleeding Academic Research Consortium (BARC) scale, and the source of bleeding was recorded.
Results


A total of 2432 patients with a high bleeding risk were included in the study. Of these patients, the mean (SD) age was 75 (9) years, and 1694 (69.7%) were men and 738 (30.3%) were women. Women and men had similar incidence of the 2-year primary safety (14.7% vs 13.6%; P = .37) and efficacy (9.2% vs 9.5%; P = .70) end points. The drug-coated stent was found to be superior to the bare-metal stent in both sexes, with lower target lesion revascularization (women: 6.3% vs 12.1%; men: 7.0% vs 12.0%; P for interaction = .70) and similar rates of the primary safety end point (women: 12.4% vs 17.0%; men: 12.6% vs 14.5%; P for interaction = .40). Overall, 2-year BARC types 3 to 5 major bleeding (10.2% vs 8.6%; P = .14) was not statistically different between the sexes, but women experienced greater BARC types 3 to 5 major bleeding within the first 30 days (5.1% vs 2.4%; P = .007) and greater vascular access site major bleeding than men (2.2% vs 0.5%; P < .001). In both sexes, vascular (women: hazard ratio [HR], 3.45 [95% CI, 1.51-7.87]; men: HR, 4.14 [95% CI, 1.33-12.95]) and nonvascular major bleeding (women: HR, 3.76 [95% CI, 2.17- 6.53]; men: HR, 4.62 [95% CI, 3.23-6.61]) were associated with greater 2-year mortality.
Conclusions and Relevance


This study found no sex differences in the ischemic outcomes of patients with a high bleeding risk after PCI, but women appeared to demonstrate greater early bleeding and major bleeding from the vascular access site. Both women and men with major bleeding seemed to experience worse 2-year mortality, suggesting that bleeding avoidance strategies should be uniformly adopted for all patients, with close attention dedicated to women to avoid denying them the benefits of PCI.
Trial Registration


ClinicalTrials.gov Identifier: NCT02843633.",2020,"The drug-coated stent was found to be superior to the bare-metal stent in both sexes, with lower target lesion revascularization","['Patients with a high bleeding risk who underwent PCI and met the trial eligibility criteria were enrolled at the participating sites and followed up for up to 2 years', 'patients with a high bleeding risk', 'patients with a high bleeding risk who were enrolled in the LEADERS FREE trial', 'Patients With a High Bleeding Risk', 'Of these patients, the mean (SD) age was 75 (9) years, and 1694 (69.7%) were men and 738 (30.3%) were women', '2432 patients with a high bleeding risk were included in the study', 'patients with a high bleeding risk after PCI, but women', '68 sites in 20 countries from December 2012 to May 2014']","['Percutaneous Coronary Intervention and 1-Month Dual Antiplatelet Therapy', 'bare-metal stent or a polymer-free, biolimus A9-eluting drug-coated stent with 1-month of dual antiplatelet therapy']","['2-year mortality', '2-year primary safety', 'composite of cardiac death, myocardial infarction, or stent thrombosis', 'nonvascular major bleeding', 'Bleeding', 'clinically driven target lesion revascularization', 'vascular access site major bleeding', 'Overall, 2-year BARC types 3 to 5 major bleeding', 'efficacy', 'early bleeding and major bleeding', 'Bleeding Academic Research Consortium (BARC) scale, and the source of bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C4310325', 'cui_str': 'Biolimus A9'}, {'cui': 'C1445093', 'cui_str': 'Drug coated stent'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449416', 'cui_str': 'Source'}]",2432.0,0.123116,"The drug-coated stent was found to be superior to the bare-metal stent in both sexes, with lower target lesion revascularization","[{'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Chandrasekhar', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Urban', 'Affiliation': 'Hôpital de la Tour, Geneva, Switzerland.'}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Lang', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Windhoevel', 'Affiliation': 'Cardiovascular European Research Center, Massy, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Spaulding', 'Affiliation': 'European Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris, Sudden Death Expert Center INSERM U 970, Paris Descartes University, Paris, France.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Copt', 'Affiliation': 'Biosensors Europe, Morges, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Stoll', 'Affiliation': 'Biosensors Europe, Morges, Switzerland.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Cardiovascular European Research Center, Massy, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2020.0285']
2681,32432770,Regulation of magnesium sulfate combined with nifedipine and labetalol on disease-related molecules in serum and placenta in the treatment of preeclampsia.,"OBJECTIVE


To explore the regulatory effect of magnesium sulfate combined with nifedipine and labetalol on disease-related molecules in serum and placenta in the treatment of preeclampsia.
PATIENTS AND METHODS


Altogether 100 patients with preeclampsia admitted to the Children & Women's Healthcare of Laiwu City were selected. They were divided into control group and experimental group according to different treatment methods. Among them, 51 patients in the control group were treated with magnesium sulfate combined with nifedipine, and 49 patients in the experimental group were treated with labetalol on the basis of the treatment in the control group. The therapeutic effects of the two methods were compared. The levels of the following factors in the two groups were compared: kallikrein expression, pregnancy-associated plasma protein A (PAPP-A), pregnancy-specific β1 glycoprotein (SPI), placental growth factor (PLGF), human placental prolactin (HPL), transforming growth factor β1(TGF-β1), vascular cell adhesion molecule 1 (VCAM-1) and E-selectin in serum and placenta tissues.
RESULTS


After treatment, the blood pressure in the experimental group was lower than that in the control group (p<0.05). The expression of kallikrein in serum and placental tissue of the patients in the experimental group was higher than that of the patients in the control group (p<0.05); PAPP-A level was lower than that in the control group (p<0.05); TGF-β1 level was higher than that in the control group (p<0.05); VCAM-1 and E-selectin were lower than those in the control group (p<0.05), and kallikrein and TGF-β1 in serum and placenta in the non-occurrence group were higher than those in the occurrence group (p<0.05). The serum and placenta PAPP-A, VCAM-1, and E-selectin in the non-occurrence group were lower than those in the occurrence group (p<0.05).
CONCLUSIONS


Magnesium sulfate combined with nifedipine and labetalol has good efficacy in the treatment of preeclampsia. They can promote the expression of endogenous kallikrein, reduce the level of pregnancy-related hypertension predictors, and weaken the infiltration ability of cytotrophoblasts.",2020,"A level was lower than that in the control group (p<0.05); TGF-β1 level was higher than that in the control group (p<0.05); VCAM-1 and E-selectin were lower than those in the control group (p<0.05), and kallikrein and TGF-β1 in serum and placenta in the non-occurrence group were higher than those in the occurrence group (p<0.05).","[""100 patients with preeclampsia admitted to the Children & Women's Healthcare of Laiwu City were selected"", 'preeclampsia']","['magnesium sulfate combined with nifedipine', 'nifedipine and labetalol', 'magnesium sulfate', 'Magnesium sulfate', 'magnesium sulfate combined with nifedipine and labetalol', 'labetalol']","['blood pressure', 'VCAM-1 and E-selectin', 'expression of kallikrein in serum and placental tissue', 'kallikrein expression, pregnancy-associated plasma protein A (PAPP-A), pregnancy-specific β1 glycoprotein (SPI), placental growth factor (PLGF), human placental prolactin (HPL), transforming growth factor β1(TGF-β1), vascular cell adhesion molecule 1 (VCAM-1) and E-selectin in serum and placenta tissues', 'serum and placenta PAPP-A, VCAM-1, and E-selectin', 'TGF-β1 level', 'kallikrein and TGF-β1 in serum and placenta']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0022860', 'cui_str': 'Labetalol'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0022478', 'cui_str': 'Kininogenase'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0694695', 'cui_str': 'Tissue specimen from placenta'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0138514', 'cui_str': 'Placenta Growth Factor'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",100.0,0.0174632,"A level was lower than that in the control group (p<0.05); TGF-β1 level was higher than that in the control group (p<0.05); VCAM-1 and E-selectin were lower than those in the control group (p<0.05), and kallikrein and TGF-β1 in serum and placenta in the non-occurrence group were higher than those in the occurrence group (p<0.05).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Obstetrics, The Children & Women's Healthcare of Laiwu City, Laiwu, P.R. China. rn72c7@163.com.""}, {'ForeName': 'D-J', 'Initials': 'DJ', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Y-X', 'Initials': 'YX', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202005_21199']
2682,32427555,"Clinical and Immunological Effects of Er,Cr:YSGG Laser in Nonsurgical Periodontal Treatment: A Randomized Clinical Trial.","Objective:  The aim of this study was to compare the clinical and immunological results of nonsurgical periodontal treatment with or without the erbium, chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG) laser.  Background data:  As lasers have begun to be used in dentistry, the Er,Cr:YSGG laser has started to attract attention in the field of periodontology.  Materials and methods:  Fifty-nine nonsmoking patients with advanced chronic periodontitis were randomly allocated to a test group (full-mouth ultrasonic supra- and subgingival debridement+Er,Cr:YSGG laser application) and a control group (full-mouth ultrasonic supra- and subgingival debridement+root planing with Gracey curettes). The laser parameters were set as follows: 1.5 W output power, pulse mode H (pulse duration of 140 μs), pulse frequency of 20 Hz, and an air-water spray ratio of 10% air and 15% water. The instrumentation was performed until the operator felt that the root surfaces were adequately debrided. Probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index, interleukin-1 beta (IL-1β), matrix metalloproteinase-8 (MMP-8), tissue inhibitor metalloproteinase-1 (TIMP-1), and MMP-8/TIMP-1 levels in gingival crevicular fluid were evaluated at baseline, 6 weeks, and 3 months postoperatively.  Results:  There were statistically significant differences in PD, which was our primary outcome, and BOP between the groups at both examinations [ p  < 0.001 and  p  < 0.001 (for PD) and  p  = 0.048 and  p  < 0.001 (for BOP), respectively], in favor of the laser group. However, there were no significant differences among groups at any time for CAL gain ( p  = 563 and  p  = 369, respectively). No significant differences in MMP-8, TIMP-1, and MMP-8/TIMP-1 levels were detected among groups. There was a statistically significant difference for IL-1β levels among groups at 3-month evaluations in favor of the laser group.  Conclusions:  Using the Er,Cr:YSGG laser instead of hand instruments in nonsurgical periodontal treatment has shown additional improvements in terms of pocket reduction and gingival bleeding compared with traditional nonsurgical therapy.",2020,"No significant differences in MMP-8, TIMP-1, and MMP-8/TIMP-1 levels were detected among groups.","['Nonsurgical Periodontal Treatment', 'Fifty-nine nonsmoking patients with advanced chronic periodontitis']","['Cr', 'Er', 'nonsurgical periodontal treatment with or without the erbium, chromium:yttrium-scandium-gallium-garnet', 'test group (full-mouth ultrasonic supra- and subgingival debridement+Er,Cr:YSGG laser application) and a control group (full-mouth ultrasonic supra- and subgingival debridement+root planing with Gracey curettes', 'YSGG laser']","['MMP-8, TIMP-1, and MMP-8/TIMP-1 levels', 'pocket reduction and gingival bleeding', 'time for CAL gain', 'PD', 'BOP', 'Probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index, interleukin-1 beta (IL-1β), matrix metalloproteinase-8 (MMP-8), tissue inhibitor metalloproteinase-1 (TIMP-1), and MMP-8/TIMP-1 levels in gingival crevicular fluid', 'IL-1β levels']","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0036274', 'cui_str': 'Scandium'}, {'cui': 'C0016980', 'cui_str': 'Gallium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0180236', 'cui_str': 'Curette'}]","[{'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0145947', 'cui_str': 'Tissue inhibitor of metalloproteinases 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C0172956', 'cui_str': 'Neutrophil collagenase'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0025543', 'cui_str': 'Metalloproteinase'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}]",59.0,0.0691438,"No significant differences in MMP-8, TIMP-1, and MMP-8/TIMP-1 levels were detected among groups.","[{'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Erbil', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Kenan', 'Initials': 'K', 'LastName': 'Nazaroglu', 'Affiliation': 'Private practice, Istanbul, Turkey.'}, {'ForeName': 'Ulku', 'Initials': 'U', 'LastName': 'Baser', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Halim', 'Initials': 'H', 'LastName': 'İssever', 'Affiliation': 'Department of Public Health, Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Sevim', 'Initials': 'S', 'LastName': 'Mese', 'Affiliation': 'Department of Virology, Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Aysen G', 'Initials': 'AG', 'LastName': 'İsik', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4748']
2683,31926810,Intermittent theta burst stimulation (iTBS) adjustment effects of schizophrenia: Results from an exploratory outcome of a randomized double-blind controlled study.,,2020,,[],"['schizophrenia', 'Intermittent theta burst stimulation (iTBS']",[],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",[],,0.447642,,"[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui, China.'}, {'ForeName': 'Xingui', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui, China; Anhui Mental Health Center, Hefei, Anhui, China.'}, {'ForeName': 'Kongliang', 'Initials': 'K', 'LastName': 'He', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui, China; Anhui Mental Health Center, Hefei, Anhui, China.'}, {'ForeName': 'Guixian', 'Initials': 'G', 'LastName': 'Xiao', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui, China.'}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Hu', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui, China.'}, {'ForeName': 'Bensheng', 'Initials': 'B', 'LastName': 'Qiu', 'Affiliation': 'Centers for Biomedical Engineering, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Gong-Jun', 'Initials': 'GJ', 'LastName': 'Ji', 'Affiliation': 'Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui, China; Anhui Mental Health Center, Hefei, Anhui, China. Electronic address: jigongjun@163.com.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui, China. Electronic address: wangkai1964@126.com.'}]",Schizophrenia research,['10.1016/j.schres.2019.12.008']
2684,32432669,Effects of Gender Bias and Stereotypes in Surgical Training: A Randomized Clinical Trial.,"Importance


Factors contributing to underrepresentation of women in surgery are incompletely understood. Pro-male bias and stereotype threat appear to contribute to gender imbalance in surgery.
Objectives


To evaluate the association between pro-male gender bias and career engagement and the effect of stereotype threat on skill performance among trainees in academic surgery.
Design, Setting, and Participants


A 2-phase study with a double-blind, randomized clinical trial component was conducted in 3 academic general surgery training programs. Residents were recruited between August 1 and August 15, 2018, and the study was completed at the end of that academic year. In phase 1, surveys administered 5 to 6 months apart investigated the association of gender bias with career engagement. In phase 2, residents were randomized 1:1 using permuted-block design stratified by site, training level, and gender to receive either a trigger of or protection against stereotype threat. Immediately after the interventions, residents completed the Fundamentals of Laparoscopic Surgery (FLS) assessment followed by a final survey. A total of 131 general surgery residents were recruited; of these 96 individuals with academic career interests met eligibility criteria; 86 residents completed phase 1. Eighty-five residents were randomized in phase 2, and 4 residents in each arm were lost to follow-up.
Intervention


Residents read abstracts that either reported that women had worse laparoscopic skill performance than men (trigger of stereotype threat [A]) or had no difference in performance (protection against stereotype threat [B]).
Main Outcomes and Measures


Association between perception of pro-male gender bias and career engagement survey scores (phase 1) and stereotype threat intervention and FLS scores (phase 2) were the outcomes. Intention-to-treat analysis was conducted.
Results


Seventy-seven residents (38 women [49.4%]) completed both phases of the study. The association between pro-male gender bias and career engagement differed by gender (interaction coefficient, -1.19; 95% CI, -1.90 to -0.49; P = .02); higher perception of bias was associated with higher engagement among men (coefficient, 1.02; 95% CI, 0.19-2.24; P = .04), but no significant association was observed among women (coefficient, -0.25; 95% CI, -1.59 to 1.08; P = .50). There was no evidence of a difference in FLS score between interventions (mean [SD], A: 395 [150] vs B: 367 [157]; P = .51). The response to stereotype threat activation was similar in men and women (interaction coefficient, 15.1; 95% CI, -124.5 to 154.7; P = .39). The association between stereotype threat activation and FLS score differed by gender across levels of susceptibility to stereotype threat (interaction coefficient, -35.3; 95% CI, -47.0 to -23.6; P = .006). Higher susceptibility to stereotype threat was associated with lower FLS scores among women who received a stereotype threat trigger (coefficient, -43.4; 95% CI, -48.0 to -38.9; P = .001).
Conclusions and Relevance


Perception of pro-male bias and gender stereotypes may influence career engagement and skill performance, respectively, among surgical trainees.
Trial Registration


ClinicalTrials.gov Identifier: NCT03623009.",2020,"The response to stereotype threat activation was similar in men and women (interaction coefficient, 15.1; 95% CI, -124.5 to 154.7; P = .39).","['Results\n\n\nSeventy-seven residents (38 women [49.4%]) completed both phases of the study', '3 academic general surgery training programs', 'Residents were recruited between August 1 and August 15, 2018, and the study was completed at the end of that academic year', 'Eighty-five residents', '131 general surgery residents were recruited; of these 96 individuals with academic career interests met eligibility criteria; 86 residents completed phase 1', 'Surgical Training', 'trainees in academic surgery']","['trigger of or protection against stereotype threat', 'stereotype threat']","['perception of pro-male gender bias and career engagement survey scores (phase 1) and stereotype threat intervention and FLS scores (phase 2', 'stereotype threat activation and FLS score', 'FLS scores', 'performance (protection against stereotype threat [B', 'skill performance', 'FLS score', 'laparoscopic skill performance', 'response to stereotype threat activation']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]",131.0,0.222041,"The response to stereotype threat activation was similar in men and women (interaction coefficient, 15.1; 95% CI, -124.5 to 154.7; P = .39).","[{'ForeName': 'Sara P', 'Initials': 'SP', 'LastName': 'Myers', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Dasari', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Lumpkin', 'Affiliation': 'Department of Surgery, University of North Carolina at Chapel Hill School of Medicine.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Chaumont', 'Affiliation': 'Department of Surgery, University of North Carolina at Chapel Hill School of Medicine.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Downs-Canner', 'Affiliation': 'Department of Surgery, University of North Carolina at Chapel Hill School of Medicine.'}, {'ForeName': 'Meghan R', 'Initials': 'MR', 'LastName': 'Flanagan', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'Kenneth K', 'Initials': 'KK', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Rosengart', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}]",JAMA surgery,['10.1001/jamasurg.2020.1127']
2685,32427567,The Effect of Mobile Application for Symptom Management on Quality of Life During Systemic Treatment in Early Breast Cancer.,"BACKGROUND


Providing cancer patients undergoing systemic therapy with useful information about symptom management is essential to prevent deterioration of quality of life (QoL).
OBJECTIVE


In our study we tested the impact of a mobile phone application for symptoms management on the QoL and use of health resources.
METHODS


We conducted a prospective cohort study evaluating QoL in early breast cancer patients receiving systemic therapy in an outpatient setting at the Institute of Oncology Ljubljana, Slovenia. The intervention group (n=46) was provided with a mobile application for Android smartphones and received the usual care, while the control group (n=45) received the usual care only. The mobile application supported daily tracking of 50 symptoms and grading their severity (mild, moderate or severe) along with in-depth descriptions and recommendations for patients depending on symptom grade. Patient-related outcomes in both groups were assessed through the European Organisation for Research and Treatment of Cancer (EORTC) C-30 and BR-23 questionnaires, as well as Health Resource Usage Questionnaire at baseline, after the first week, after the first cycle and at the end of treatment. The primary goal was to assess the difference between groups in the global QoL and the summary score of the EORTC C-30 questionnaire after the first week, after the first cycle and at the end of treatment. Other scales were compared only exploratory. The secondary outcome was the use of health resources.
RESULTS


The mean difference between the groups in the global QoL after the first week was 10.1 (95% confidence interval (CI) [1.8, 18.5], P=.02) when adjusted for value at baseline and type of surgery. The difference in summary score between the intervention and the control group was statistically significant after the first week (higher for the intervention group; adjusted mean 8.9, 95% CI [3.1, 14.7], P=.003) and at the end of treatment (adjusted mean 10.6, 95% CI [3.9, 17.3], P=.002). The difference in use of health resources (visits to the doctor and hospitalizations) between the groups was not statistically significant (in the first week: P=.12; in the first cycle: P=.13). In the exploratory analysis, the application contributed to clinically important improvements in social, physical, role and cognitive functioning, while diminishing pain, appetite loss and systemic therapy side effects.
CONCLUSIONS


The use of the mobile application enabled patients undergoing systemic therapy to cope better with symptoms as indicated by a better global QoL and summary score after the first week and by a better summary score at the end of treatment in comparison to the control group, but we have not found a statistically significant impact on the use of health resources.
CLINICALTRIAL


EUDRACT protocol number 2018-001869-16.",2020,The difference in use of health resources (visits to the doctor and hospitalizations) between the groups was not statistically significant (in the first week: P=.12; in the first cycle: P=.13).,"['Early Breast Cancer', 'cancer patients undergoing', 'early breast cancer patients receiving systemic therapy in an outpatient setting at the Institute of Oncology Ljubljana, Slovenia']","['Mobile Application', 'mobile phone application', 'mobile application for Android smartphones and received the usual care, while the control group (n=45) received the usual care only', 'systemic therapy']","['Quality of Life', 'health resources (visits to the doctor and hospitalizations', 'social, physical, role and cognitive functioning', 'pain, appetite loss and systemic therapy side effects', 'global QoL and the summary score of the EORTC C-30 questionnaire', 'European Organisation for Research and Treatment of Cancer (EORTC) C-30 and BR-23 questionnaires, as well as Health Resource Usage Questionnaire', 'global QoL', 'use of health resources']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0037334', 'cui_str': 'Slovenia'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]",,0.071007,The difference in use of health resources (visits to the doctor and hospitalizations) between the groups was not statistically significant (in the first week: P=.12; in the first cycle: P=.13).,"[{'ForeName': 'Cvetka', 'Initials': 'C', 'LastName': 'Grašič Kuhar', 'Affiliation': 'Department of Medical Oncology, Institute of Oncology Ljubljana, Zaloška 2, Ljubljana, SI.'}, {'ForeName': 'Tjaša', 'Initials': 'T', 'LastName': 'Gortnar Cepeda', 'Affiliation': 'Faculty of Medicine Ljubljana, University of Ljubljana, Ljubljana, SI.'}, {'ForeName': 'Timotej', 'Initials': 'T', 'LastName': 'Kovač', 'Affiliation': 'Faculty of Computer and Information Science, University of Ljubljana, Ljubljana, SI.'}, {'ForeName': 'Matjaž', 'Initials': 'M', 'LastName': 'Kukar', 'Affiliation': 'Faculty of Computer and Information Science, University of Ljubljana, Ljubljana, SI.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Ružić Gorenjec', 'Affiliation': 'Institute for Biostatistics and Medical Informatics, Faculty of Medicine Ljubljana, University of Ljubljana, Ljubljana, SI.'}]",JMIR mHealth and uHealth,['10.2196/17408']
2686,32427638,THE 11TH TRIAL OF A CARDIOVASCULAR CLINICAL TRIALIST -CORONAVIRUS-2 (SARS-CoV2): PART 1.,,2020,,[],[],[],[],[],[],,0.0179934,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'from the Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, N.Y.'}]",Cardiology in review,['10.1097/CRD.0000000000000316']
2687,32427667,Racial Differences in the Influence of Health Care System Factors on Informal Support for Cancer Care Among Black and White Breast and Lung Cancer Survivors.,"This retrospective, secondary qualitative analysis investigates whether health system factors influence social support among Black and white breast and lung cancer survivors and racial differences in support. These data come from race- and cancer-stratified focus groups (n = 6) and interviews (n = 2) to inform a randomized controlled trial utilizing antiracism and community-based participatory research approaches. Findings indicate social support was helpful for overcoming treatment-related challenges, including symptom management and patient-provider communication; racial differences in support needs and provision were noted. Resources within individual support networks reflect broader sociostructural factors. Reliance on family/friends to fill gaps in cancer care may exacerbate racial disparities.",2020,"Findings indicate social support was helpful for overcoming treatment-related challenges, including symptom management and patient-provider communication; racial differences in support needs and provision were noted.","['Cancer Care', 'Black and White Breast and Lung Cancer Survivors', 'Black and white breast and lung cancer survivors']",['health system factors influence social support'],[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",[],6.0,0.0371642,"Findings indicate social support was helpful for overcoming treatment-related challenges, including symptom management and patient-provider communication; racial differences in support needs and provision were noted.","[{'ForeName': 'Katrina R', 'Initials': 'KR', 'LastName': 'Ellis', 'Affiliation': 'Greensboro Health Disparities Collaborative, North Carolina (Drs Ellis, Black, Baker, Davis, Doost, Lightfoot, Samuel, Schaal, and Eng and Mss Cothern, Goestch, Griesemer, Guerrab, Padilla, and Yongue); School of Social Work, University of Michigan, Ann Arbor (Dr Ellis); College of Health and Human Performance, East Carolina University, Greenville (Dr Black); Public Health Studies Program, Elon University, North Carolina (Dr Baker); School of Medicine, Washington University, St Louis, Missouri (Dr Davis); Departments of Health Behavior (Mss Griesemer and Guerrab and Drs Lightfoot and Eng) and Health Policy and Management (Ms Padilla and Dr Samuel), University of North Carolina, Chapel Hill; Center for Health Promotion and Disease Prevention, University of North Carolina (Dr Lightfoot); The Partnership Project, Inc, Greensboro, North Carolina (Dr Schaal); and Department of Public Health Education, University of North Carolina at Greensboro (Ms Yongue).'}, {'ForeName': 'Kristin Z', 'Initials': 'KZ', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Cothern', 'Affiliation': ''}, {'ForeName': 'Kia', 'Initials': 'K', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Doost', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Goestch', 'Affiliation': ''}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Griesemer', 'Affiliation': ''}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Guerrab', 'Affiliation': ''}, {'ForeName': 'Alexandra F', 'Initials': 'AF', 'LastName': 'Lightfoot', 'Affiliation': ''}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Padilla', 'Affiliation': ''}, {'ForeName': 'Cleo A', 'Initials': 'CA', 'LastName': 'Samuel', 'Affiliation': ''}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Schaal', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Yongue', 'Affiliation': ''}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Eng', 'Affiliation': ''}]",Family & community health,['10.1097/FCH.0000000000000264']
2688,32427553,"Effectiveness of Photobiomodulation in Temporomandibular Disorder-Related Pain Using a 635 nm Diode Laser: A Randomized, Blinded, and Placebo-Controlled Clinical Trial.","Objective:  We aimed to evaluate the efficacy of photobiomodulation (PBM), using an 635 nm diode laser, to provide pain relief for temporomandibular disorder (TMD).  Background data:  TMD involves a set of multiple clinical manifestations where pain is prevalent. Treatment ideally should be noninvasive and innocuous such as PBM.  Methods:  A randomized, placebo-controlled, clinically blinded trial was performed on 42 patients with painful TMD diagnosed according the Research Diagnostic Criteria for Temporomandibular Disorders. They were randomly placed into two groups: an intervention group ( n  = 22) subjected to the application of a 635 nm wavelength diode laser (using a 8-mm diameter handpiece in contact mode, delivering 8 J/cm 2  over a period of 20 sec applied over the sensitive points where the pain was reported by the participants) and a placebo group ( n  = 20) following the same protocol but without laser activation. All patients received four sessions of treatment over 4 weeks. Personal pain perception, nonassisted pain-free maximum mouth opening and tenderness elicited during palpation of muscles were used as primary outcomes, evaluated at baseline and at follow-up 1 month later by blinded, calibrated evaluators.  Results:  There was a significant reduction in the degree of pain recorded in the laser group after treatment (0.63 ± 0.36) compared with the baseline evaluation (4.59 ± 2.36;  p  < 0.001), which was not observed in the placebo group. Reduction of pain during palpation of most masticatory muscles was significant following treatment in the intervention group. A significant increase in the nonassisted painless mouth opening was observed after treatment (42.14 ± 5.8 mm) compared with baseline values (36.73 ± 9.91 mm) only among the laser group ( p  = 0.007). There were no reported adverse events or side effects among the patients in the intervention group.  Conclusions:  Our results suggest that PBM using a 635 nm laser was effective on the remission of painful TMD, without complications.",2020,"Our results suggest that PBM using a 635 nm laser was effective on the remission of painful TMD, without complications.","['temporomandibular disorder (TMD', '42 patients with painful TMD diagnosed according the Research Diagnostic Criteria for Temporomandibular Disorders', 'Temporomandibular Disorder-Related Pain Using a 635\u2009nm Diode Laser']","['Placebo', 'intervention group ( n \u2009=\u200922) subjected to the application of a 635\u2009nm wavelength diode laser', 'photobiomodulation (PBM', '635\u2009nm diode laser', 'TMD', 'Photobiomodulation', 'PBM', 'placebo']","['degree of pain', 'Personal pain perception, nonassisted pain-free maximum mouth opening and tenderness elicited', 'remission of painful TMD', 'nonassisted painless mouth opening', 'Reduction of pain', 'adverse events or side effects']","[{'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0065764', 'cui_str': 'MBD protocol'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",42.0,0.21634,"Our results suggest that PBM using a 635 nm laser was effective on the remission of painful TMD, without complications.","[{'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Monteiro', 'Affiliation': 'Oral Medicine and Oral Surgery Department, University Institute of Health Sciences, CESPU, Gandra, Portugal.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Ferreira', 'Affiliation': 'Cancer Research Group-IINFACTS, University Institute of Health Sciences, CESPU, Gandra, Portugal.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Resende', 'Affiliation': 'Oral Medicine and Oral Surgery Department, University Institute of Health Sciences, CESPU, Gandra, Portugal.'}, {'ForeName': 'José Júlio', 'Initials': 'JJ', 'LastName': 'Pacheco', 'Affiliation': 'Oral Medicine and Oral Surgery Department, University Institute of Health Sciences, CESPU, Gandra, Portugal.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Salazar', 'Affiliation': 'Oral Medicine and Oral Surgery Department, University Institute of Health Sciences, CESPU, Gandra, Portugal.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4730']
2689,31358436,Methylphenidate and atomoxetine normalise fronto-parietal underactivation during sustained attention in ADHD adolescents.,"Problems with sustained attention are a key clinical feature of Attention Deficit/Hyperactivity Disorder (ADHD) which also manifests in poor performance and abnormal fronto-striato-parietal activation during sustained attention. Methylphenidate and atomoxetine improve attention functions and upregulate abnormal fronto-cortical activation during executive function tasks in ADHD patients. Despite this, no functional Magnetic Resonance Imaging (fMRI) study has compared the effects of methylphenidate and atomoxetine on the neurofunctional substrates of sustained attention in ADHD. This randomised, double-blind, placebo-controlled, cross-over study investigated the comparative normalisation effects of methylphenidate and atomoxetine on fMRI correlates and performance in 14 ADHD adolescents relative to 27 age-matched healthy controls during a parametric sustained attention/vigilance task with progressively increasing load of sustained attention. ADHD patients were scanned three times under a single clinical dose of either methylphenidate, atomoxetine, or placebo in pseudo-randomised order. Healthy controls were scanned once and compared to patients under each drug condition to test for potential drug-normalisation effects. Relative to controls, ADHD boys under placebo were impaired in performance and had underactivation in predominantly right-hemispheric fronto-parietal, and striato-thalamic regions. Both drugs normalised all underactivations, while only methylphenidate improved performance deficits. Within patients, methylphenidate had a drug-specific effect of upregulating left ventrolateral prefrontal/superior temporal activation relative to placebo and atomoxetine, while both drugs increased activation of right middle/superior temporal cortex, posterior cingulate, and precuneus relative to placebo. The study shows shared normalisation effects of methylphenidate and atomoxetine on fronto-striato-thalamo-parietal dysfunction in ADHD during sustained attention but a drug-specific upregulation effects of methylphenidate on ventral fronto-temporal regions.",2019,"Relative to controls, ADHD boys under placebo were impaired in performance and had underactivation in predominantly right-hemispheric fronto-parietal, and striato-thalamic regions.","['ADHD adolescents', '14 ADHD adolescents relative to 27 age-matched healthy controls during a parametric sustained attention/vigilance task with progressively increasing load of sustained attention', 'ADHD patients']","['Methylphenidate and atomoxetine', 'placebo and atomoxetine', 'placebo', 'methylphenidate, atomoxetine, or placebo', 'methylphenidate and atomoxetine', 'methylphenidate']","['fMRI correlates and performance', 'performance deficits']","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention, function (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}]",,0.258623,"Relative to controls, ADHD boys under placebo were impaired in performance and had underactivation in predominantly right-hemispheric fronto-parietal, and striato-thalamic regions.","[{'ForeName': 'Olivia S', 'Initials': 'OS', 'LastName': 'Kowalczyk', 'Affiliation': 'Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, De Crespigny Park, London SE5 8AF, UK. Electronic address: olivia.kowalczyk@kcl.ac.uk.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Cubillo', 'Affiliation': 'Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, De Crespigny Park, London SE5 8AF, UK; Jacobs Center for Productive Youth Development, Zurich Center for Neuroeconomics, University of Zürich, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, De Crespigny Park, London SE5 8AF, UK.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Barrett', 'Affiliation': 'Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, De Crespigny Park, London SE5 8AF, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Giampietro', 'Affiliation': 'Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brammer', 'Affiliation': 'Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Simmons', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, UK; Centre for Neurodegeneration Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK; NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Trust and Institute of Psychiatry, Psychology & Neuroscience, King's College, London, UK.""}, {'ForeName': 'Katya', 'Initials': 'K', 'LastName': 'Rubia', 'Affiliation': 'Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King´s College London, De Crespigny Park, London SE5 8AF, UK.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.07.139']
2690,32428718,Prospective randomized study on the effects of improved sleep quality after craniotomy on melatonin concentrations and inflammatory response in neurosurgical intensive-care patients 2 .,"OBJECTIVE


Sleep disorders in intensive care units (ICU) after a craniotomy can decrease melatonin secretion and increase the inflammatory stress response. The aim of this study was to investigate the influence of improving sleep quality via eye patches and earplugs on melatonin secretion and inflammatory mediator release.
METHODS


The study enrolled 41 patients who underwent craniotomy. Patients were randomized into two groups. Group Intervention received a sleep-promoting intervention with eye patches and earplugs to provide light and noise isolation, while Group Control received standard care. Blood levels of C reactive protein (CRP) and interleukin 1(IL-1) and 6 (IL-6) along with urine levels of 6-sulphatoxymelatonin (aMT6) were measured preoperatively (baseline) and on postoperative days1 and 3. Sleep quality was assessed with the Richards-Campbell Sleep Questionnaire.
RESULTS


Sleep quality was higher in the intervention group (Richards-Campbell score:80.61±11.96 vs.33.50±16.32; p<0.001). Urine aMT6 levels increased significantly in the intervention group in spot urine samples from 10.15 (5.38-14.40) ng/ml at baseline to 14.52 (6.24-29.11) and 11.51 (7.88-29.05) ng/ml on postoperative days 1 and 3. They also increased in 24-hour urine samples from 25.73 (8.24-52.73) ng/ml at baseline to 35.38 (11.48-95.65) and 39.18 (2.36-125.23) ng/ml on postoperative days 1 and 3 (p=0.001 and p=0.005, respectively). The aMT6 concentration did not change significantly in the control group. The CRP concentrations increased postoperatively compared to baseline concentrations in both groups (p=0.001 and p<0.001).
CONCLUSIONS


Melatonin secretion significantly increased as a result of improving postoperative sleep quality by noise and light isolation in neurosurgical ICU patients after craniotomy.",2020,"The CRP concentrations increased postoperatively compared to baseline concentrations in both groups (p=0.001 and p<0.001).
","['neurosurgical ICU patients after craniotomy', 'neurosurgical intensive-care patients 2 ', '41 patients who underwent craniotomy']","['sleep-promoting intervention with eye patches and earplugs to provide light and noise isolation, while Group Control received standard care']","['levels', 'Blood levels of C reactive protein (CRP) and interleukin 1(IL-1) and 6 (IL-6) along with urine levels of 6-sulphatoxymelatonin (aMT6', '24-hour urine samples', 'aMT6 concentration', 'Urine aMT6', 'Sleep quality', 'postoperative sleep quality', 'CRP concentrations', 'melatonin secretion', 'sleep quality', 'inflammatory stress response']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0776981', 'cui_str': 'Eye patch'}, {'cui': 'C1135964', 'cui_str': 'Ear plug'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0049713', 'cui_str': '6-sulfatoxymelatonin'}, {'cui': 'C0456209', 'cui_str': '24 hour urine sample'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",41.0,0.140342,"The CRP concentrations increased postoperatively compared to baseline concentrations in both groups (p=0.001 and p<0.001).
","[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Arık', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey. Electronic address: emineincearik@yahoo.com.'}, {'ForeName': 'Habibullah', 'Initials': 'H', 'LastName': 'Dolgun', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Sahin', 'Initials': 'S', 'LastName': 'Hanalioglu', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Omer Selcuk', 'Initials': 'OS', 'LastName': 'Sahin', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Ucar', 'Affiliation': 'Department of Clinical Biochemistry, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Yazicioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ihsan', 'Initials': 'I', 'LastName': 'Dogan', 'Affiliation': 'Department of Neurosurgery, Ankara University, İbn-i Sina Hospital, Ankara, Turkey.'}, {'ForeName': 'Erdal Resit', 'Initials': 'ER', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}]",World neurosurgery,['10.1016/j.wneu.2020.05.017']
2691,32119599,"Ten-Year Update of a Randomized, Prospective Trial of Conventional Fractionated Versus Moderate Hypofractionated Radiation Therapy for Localized Prostate Cancer.","PURPOSE


The previously published single institution randomized prospective trial failed to show superiority in the 5-year biochemical and/or clinical disease failure (BCDF) rate with moderate hypofractionated intensity-modulated radiation therapy (H-IMRT) versus conventionally fractionated IMRT (C-IMRT). We now present 10-year disease outcomes using updated risk groups and definitions of biochemical failure.
METHODS


Men with protocol-defined intermediate- and high-risk prostate adenocarcinoma were randomly assigned to receive C-IMRT (76 Gy in 38 fractions) or H-IMRT (70.2 Gy in 26 fractions). Men with high-risk disease were all prescribed 24 months of androgen deprivation therapy (ADT) and had lymph node irradiation. Men with intermediate risk were prescribed 4 months of ADT at the discretion of the treating physician. The primary endpoint was cumulative incidence of BCDF. We compared disease outcomes and overall mortality by treatment arm, with sensitivity analyses for National Comprehensive Cancer Network (NCCN) risk group adjustment.
RESULTS


Overall, 303 assessable men were randomly assigned to C-IMRT or H-IMRT. The median follow-up was 122.9 months. Per updated NCCN risk classification, there were 28 patients (9.2%) with low-risk, 189 (62.4%) with intermediate-risk, and 86 (28.4%) with high-risk prostate cancer. The arms were equally balanced for clinicopathologic factors, except that there were more black patients in the C-IMRT arm (17.8%  v  7.3%;  P  = .02). There was no difference in ADT use ( P  = .56). The 10-year cumulative incidence of BCDF was 25.9% in the C-IMRT arm and was 30.6% in the H-IMRT arm (hazard ratio, 1.31; 95% CI, 0.82 to 2.11). The two arms also had similar cumulative 10-year rates of biochemical failure, prostate cancer-specific mortality, and overall mortality; however, the 10-year cumulative incidence of distant metastases was higher in the H-IMRT arm (rate difference, 7.8%; 95% CI, 0.7% to 15.1%).
CONCLUSION


H-IMRT failed to demonstrate superiority compared with C-IMRT in long-term disease outcomes.",2020,"The two arms also had similar cumulative 10-year rates of biochemical failure, prostate cancer-specific mortality, and overall mortality; however, the 10-year cumulative incidence of distant metastases was higher in the H-IMRT arm (rate difference, 7.8%; 95% CI, 0.7% to 15.1%).
","['Men with protocol-defined intermediate- and high-risk prostate adenocarcinoma', 'Men with intermediate risk', 'Men with high-risk disease were all prescribed 24 months of androgen deprivation therapy (ADT) and had lymph node irradiation', 'Localized Prostate Cancer', '303 assessable men']","['C-IMRT or H-IMRT', 'Conventional Fractionated Versus Moderate Hypofractionated Radiation Therapy', 'C-IMRT', 'H-IMRT', 'moderate hypofractionated intensity-modulated radiation therapy (H-IMRT) versus conventionally fractionated IMRT (C-IMRT']","['disease outcomes and overall mortality', 'cumulative 10-year rates of biochemical failure, prostate cancer-specific mortality, and overall mortality', 'cumulative incidence of BCDF', '10-year cumulative incidence of BCDF', '10-year cumulative incidence of distant metastases', '5-year biochemical and/or clinical disease failure (BCDF) rate']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",303.0,0.150133,"The two arms also had similar cumulative 10-year rates of biochemical failure, prostate cancer-specific mortality, and overall mortality; however, the 10-year cumulative incidence of distant metastases was higher in the H-IMRT arm (rate difference, 7.8%; 95% CI, 0.7% to 15.1%).
","[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Avkshtol', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Ruth', 'Affiliation': 'Department of Biostatistics, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Ross', 'Affiliation': 'Department of Biostatistics, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Hallman', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Greenberg', 'Affiliation': 'Division of Urologic Oncology, Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Price', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Leachman', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Uzzo', 'Affiliation': 'Division of Urologic Oncology, Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Division of Urologic Oncology, Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Geynisman', 'Affiliation': 'Division of Genitourinary Oncology, Department of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Sobczak', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Wong', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Pollack', 'Affiliation': 'Department of Radiation Oncology, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Horwitz', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01485']
2692,32427723,Smartphone app and carbon monoxide self-monitoring support for smoking cessation: A randomised controlled trial nested into the Swiss HIV Cohort Study.,,2020,,"['smoking cessation', 'Swiss HIV Cohort Study']",['Smartphone app and carbon monoxide self-monitoring support'],[],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",[],,0.0705271,,"[{'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Gryaznov', 'Affiliation': 'Basel Institute for Clinical Epidemiology & Biostatistics, University Hospital Basel and University of Basel, Basel Switzerland.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Chammartin', 'Affiliation': 'Basel Institute for Clinical Epidemiology & Biostatistics, University Hospital Basel and University of Basel, Basel Switzerland.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Stoeckle', 'Affiliation': 'Division of Infectious Diseases and Hospital Hygiene University Hospital Basel and University of Basel, Basel Switzerland.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Anagnostopoulos', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich and University of Zurich, Zurich Switzerland.'}, {'ForeName': 'Dominique Laurent', 'Initials': 'DL', 'LastName': 'Braun', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich and University of Zurich, Zurich Switzerland.'}, {'ForeName': 'Hansjakob', 'Initials': 'H', 'LastName': 'Furrer', 'Affiliation': 'Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern Switzerland.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Boillat-Blanco', 'Affiliation': 'Infectious Diseases Service, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Enos', 'Initials': 'E', 'LastName': 'Bernasconi', 'Affiliation': 'Division of Infectious Diseases, Ospedale Regionale di Lugano - Civico e Italiano, Lugano, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Division of Infectious Diseases and Hospital Hygiene, Kantonsspital St. Gallen, St.Gallen, Switzerland.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Nordmann', 'Affiliation': 'Basel Institute for Clinical Epidemiology & Biostatistics, University Hospital Basel and University of Basel, Basel Switzerland.'}, {'ForeName': 'Heiner C', 'Initials': 'HC', 'LastName': 'Bucher', 'Affiliation': 'Basel Institute for Clinical Epidemiology & Biostatistics, University Hospital Basel and University of Basel, Basel Switzerland.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002396']
2693,32427788,Highly Hydrophilic Polyurethane Foam Dressing Versus Early Hydrophilic Polyurethane Foam Dressing on Skin Graft Donor Site Healing in Patients with Diabetes: An Exploratory Clinical Trial.,"OBJECTIVE


To compare the effects of early hydrophilic polyurethane (EHP) foam dressing and highly hydrophilic polyurethane (HHP) foam dressing on wound healing in patients with diabetes.
METHODS


Twenty patients with diabetes with skin graft donor sites on the lateral thigh were enrolled in this study. Each donor site was divided into two equal-sized areas for the application of HHP or EHP foam dressing. The study endpoint was the time required for healing, defined as complete epithelialization of the donor site without discharge. All possible adverse events were also documented.
MAIN RESULTS


Donor site healing was faster in 15 patients on the HHP half and 1 patient on the EHP half. In four patients, healing rates were the same between the HHP and EHP areas. Donor sites treated with HHP and EHP foam dressings healed in 17.2 ± 4.4 and 19.6 ± 3.7 days (P = .007), respectively. During the study period, no adverse event associated with the dressings occurred in either group.
CONCLUSIONS


The HHP foam dressing might provide faster healing than EHP foam dressing for skin graft donor sites in patients with diabetes.",2020,The HHP foam dressing might provide faster healing than EHP foam dressing for skin graft donor sites in patients with diabetes.,"['patients with diabetes', 'Patients with Diabetes', 'Twenty patients with diabetes with skin graft donor sites on the lateral thigh were enrolled in this study']","['early hydrophilic polyurethane (EHP) foam dressing and highly hydrophilic polyurethane (HHP) foam dressing', 'EHP foam dressing', 'Hydrophilic Polyurethane Foam Dressing Versus Early Hydrophilic Polyurethane Foam Dressing', 'HHP or EHP foam dressing']","['Skin Graft Donor Site Healing', 'time required for healing, defined as complete epithelialization of the donor site without discharge', 'Donor site healing', 'wound healing', 'healing rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037297', 'cui_str': 'Grafting to skin'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0475370', 'cui_str': 'Hydrophilic'}, {'cui': 'C0032616', 'cui_str': 'Polyisocyanate'}, {'cui': 'C3164124', 'cui_str': 'Foam dressing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0460852', 'cui_str': 'Polyurethane foam dressing'}]","[{'cui': 'C0037297', 'cui_str': 'Grafting to skin'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",20.0,0.0179926,The HHP foam dressing might provide faster healing than EHP foam dressing for skin graft donor sites in patients with diabetes.,"[{'ForeName': 'Sik', 'Initials': 'S', 'LastName': 'Namgoong', 'Affiliation': 'In the Department of Plastic Surgery at Korea University College of Medicine, in Seoul, South Korea, Sik Namgoong, MD, PhD, is Clinical Assistant Professor; Jae-Eun Jung, MD, is a resident; Young-Don Yoon, MD, is a resident; and Seung-Kyu Han, MD, PhD, is Professor. In the Department of Nursing Service at Korea University Guro Hospital in Seoul, South Korea, Ye-Na Lee, MSc, RN, WCN, and Ji-Won Son, RN, WCN, are wound care nurses. Acknowledgment: This study was supported by grants from Il-Dong Pharmaceutical Co., Seoul, South Korea (No. I1500851). The authors have disclosed no other financial relationships related to this article. Submitted April 21, 2019; accepted in revised form July 9, 2019.'}, {'ForeName': 'Jae-Eun', 'Initials': 'JE', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Young-Don', 'Initials': 'YD', 'LastName': 'Yoon', 'Affiliation': ''}, {'ForeName': 'Seung-Kyu', 'Initials': 'SK', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Ye-Na', 'Initials': 'YN', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Ji-Won', 'Initials': 'JW', 'LastName': 'Son', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000661792.04223.02']
2694,31956263,Modulation of blood pressure-lowering effects of dark chocolate according to an insulin sensitivity-randomized crossover study.,,2020,,[],['dark chocolate'],[],[],"[{'cui': 'C3853217', 'cui_str': 'Dark chocolate (substance)'}]",[],,0.0609042,,"[{'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan. tomiyama@tokyo-med.ac.jp.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Shiina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Kamei', 'Affiliation': 'Morinaga & Co., Ltd., R&D Institute, Kanagawa, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Inagaki', 'Affiliation': 'Morinaga & Co., Ltd., R&D Institute, Kanagawa, Japan.'}, {'ForeName': 'Taishirou', 'Initials': 'T', 'LastName': 'Chikamori', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yamshina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-020-0395-3']
2695,32017597,Pulse Wave Velocity in Chronic Obstructive Pulmonary Disease and the Impact of Inhaled Therapy (SUMMIT): A Randomized Double-Blind Clinical Trial.,,2020,,[],['Inhaled Therapy (SUMMIT'],[],[],"[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.735713,,"[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'GlaxoSmithKline plcResearch Triangle Park, North Carolina.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Anderson', 'Affiliation': 'GlaxoSmithKline plcMiddlesex, United Kingdom.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'University Hospital AintreeLiverpool, United Kingdom.'}, {'ForeName': 'Bartolome R', 'Initials': 'BR', 'LastName': 'Celli', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical SchoolBoston, Massachusetts.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Cowans', 'Affiliation': 'Veramed Ltd.Twickenham, United Kingdom.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell MedicineNew York, New York.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'University of EdinburghEdinburgh, United Kingdom.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'The University of Manchester Manchester, United Kingdom.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Yates', 'Affiliation': 'GlaxoSmithKline plcResearch Triangle Park, North Carolina.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'University of MichiganAnn Arbor, Michigan.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201908-1639LE']
2696,31515141,"A phase 1 study of the safety, reactogenicity, and immunogenicity of a Schistosoma mansoni vaccine with or without glucopyranosyl lipid A aqueous formulation (GLA-AF) in healthy adults from a non-endemic area.","BACKGROUND


Schistosomiasis caused by Schistosoma mansoni (Sm) is a chronic, debilitating and potentially deadly neglected tropical disease. The licensure of a vaccine to prevent schistosomiasis would represent a major breakthrough in public health.
METHODS


The safety and immunogenicity of a candidate Sm vaccine were assessed in this phase I, double-blind, dose-escalation trial. Seventy-two healthy Sm-naïve 18-50 year olds were randomized to receive 3 doses ∼ 8 weeks apart of saline placebo, or 10 µg, 30 µg, or 100 µg of recombinant Sm-Tetraspanin-2 vaccine formulated on aluminum hydroxide adjuvant (Sm-TSP-2/Al) with or without 5 µg of glucopyranosyl lipid A aqueous formulation (GLA-AF). Clinical and serologic responses were assessed for 1 year after dose 3.
RESULTS


Vaccines were safe and well-tolerated. The most common reactions were injection site tenderness and pain, and headache and fatigue. Tenderness and pain were more frequent in groups receiving vaccine with GLA-AF than placebo (p = 0.0036 and p = 0.0014, respectively). Injection site reactions among those given Sm-TSP-2/Al with GLA-AF lasted 1.22 and 1.33 days longer than those receiving Sm-TSP-2/Al without GLA-AF or placebo (p < 0.001 for both). Dose- and adjuvant-related increases in serum IgG against Sm-TSP-2 were observed. Peak IgG levels occurred 14 days after dose 3. Seroresponse frequencies were low among recipients of Sm-TSP-2/Al without GLA-AF, but higher among subjects receiving 30 µg or 100 µg of Sm-TSP-2/Al with GLA-AF. More seroresponses were observed among those given 30 µg or 100 µg of Sm-TSP-2/Al with GLA-AF compared to placebo (p = 0.023 and p < 0.001, respectively). Seroresponse frequencies were 0%, 30%, 50%, and 89%, respectively, among those given placebo, or 10 µg, 30 µg or 100 µg of Sm-TSP-2/Al with GLA-AF, suggesting a dose-response relationship for Sm-TSP-2/Al with GLA-AF (p = 0.0001).
CONCLUSIONS


Sm-TSP-2/Al with or without GLA-AF was safe and well tolerated in a Sm-naïve population. A vaccine like the one under development may represent our best hope to eliminating this neglected tropical disease.",2019,"More seroresponses were observed among those given 30 µg or 100 µg of Sm-TSP-2/Al with GLA-AF compared to placebo (p = 0.023 and p < 0.001, respectively).","['healthy adults from a non-endemic area', 'Seventy-two healthy Sm-naïve 18-50\u202fyear olds']","['Sm-TSP-2/Al with or without GLA', 'saline placebo', 'Schistosoma mansoni vaccine with or without glucopyranosyl lipid A aqueous formulation (GLA-AF', 'placebo', 'recombinant Sm-Tetraspanin-2 vaccine formulated on aluminum hydroxide adjuvant (Sm-TSP-2/Al) with or without 5\u202fµg of glucopyranosyl lipid A aqueous formulation (GLA-AF']","['safe and well-tolerated', 'serum IgG against Sm-TSP-2', 'Clinical and serologic responses', 'Tenderness and pain', 'Seroresponse frequencies', 'Injection site reactions', 'injection site tenderness and pain, and headache and fatigue', 'safe and well tolerated', 'safety and immunogenicity', 'Peak IgG levels', 'safety, reactogenicity, and immunogenicity']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036319', 'cui_str': 'Schistosoma mansoni'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C4276833', 'cui_str': 'glucopyranosyl lipid-A'}, {'cui': 'C3178812', 'cui_str': 'Tetraspanins'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205473', 'cui_str': 'Serologic (qualifier value)'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0863083', 'cui_str': 'Injection site tenderness'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",72.0,0.0857473,"More seroresponses were observed among those given 30 µg or 100 µg of Sm-TSP-2/Al with GLA-AF compared to placebo (p = 0.023 and p < 0.001, respectively).","[{'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Keitel', 'Affiliation': 'Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States. Electronic address: wkeitel@bcm.edu.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Potter', 'Affiliation': 'The Emmes Corporation, United States.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Diemert', 'Affiliation': 'Department of Microbiology, Immunology and Tropical Medicine, The George Washington University, Washington, DC, United States.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bethony', 'Affiliation': 'Department of Microbiology, Immunology and Tropical Medicine, The George Washington University, Washington, DC, United States.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'El Sahly', 'Affiliation': 'Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Kennedy', 'Affiliation': 'The Emmes Corporation, United States.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Patel', 'Affiliation': 'Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Plieskatt', 'Affiliation': 'Department of Microbiology, Immunology and Tropical Medicine, The George Washington University, Washington, DC, United States.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Jones', 'Affiliation': 'Division of Microbiology and Infectious Diseases (DMID), National Institutes of Allergy and Infectious. Diseases (NIAID), National Institutes of Health (NIH), United States.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Deye', 'Affiliation': 'Division of Microbiology and Infectious Diseases (DMID), National Institutes of Allergy and Infectious. Diseases (NIAID), National Institutes of Health (NIH), United States.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Bottazzi', 'Affiliation': ""Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States; Texas Children's Hospital Center for Vaccine Development, Department of Pediatrics, Baylor College of Medicine, Houston, TX, United States.""}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Hotez', 'Affiliation': ""Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States; Texas Children's Hospital Center for Vaccine Development, Department of Pediatrics, Baylor College of Medicine, Houston, TX, United States.""}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States.'}]",Vaccine,['10.1016/j.vaccine.2019.08.075']
2697,32427675,Allogenic Fecal Microbiota Transplantation in Patients With Nonalcoholic Fatty Liver Disease Improves Abnormal Small Intestinal Permeability: A Randomized Control Trial.,"INTRODUCTION


Nonalcoholic fatty liver disease (NAFLD) is an obesity-related disorder that is rapidly increasing in incidence and is considered the hepatic manifestation of the metabolic syndrome. The gut microbiome plays a role in metabolism and maintaining gut barrier integrity. Studies have found differences in the microbiota between NAFLD and healthy patients and increased intestinal permeability in patients with NAFLD. Fecal microbiota transplantation (FMT) can be used to alter the gut microbiome. It was hypothesized that an FMT from a thin and healthy donor given to patients with NAFLD would improve insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability.
METHODS


Twenty-one patients with NAFLD were recruited and randomized in a ratio of 3:1 to either an allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum. IR was calculated by HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability was tested using the lactulose:mannitol urine test. Additional markers of metabolic syndrome and the gut microbiota were examined. Patient visits occurred at baseline, 2, 6 weeks, and 6 months post-FMT.
RESULTS


There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT. Allogenic FMT patients with elevated small intestinal permeability (>0.025 lactulose:mannitol, n = 7) at baseline had a significant reduction 6 weeks after allogenic FMT.
DISCUSSION


FMT did not improve IR as measured by HOMA-IR or hepatic PDFF but did have the potential to reduce small intestinal permeability in patients with NAFLD.",2020,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"['Patients With Nonalcoholic Fatty Liver Disease Improves', 'patients with NAFLD', 'Twenty-one patients with NAFLD', 'Abnormal Small Intestinal Permeability']","['Allogenic Fecal Microbiota Transplantation', 'Fecal microbiota transplantation (FMT', 'allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum', 'FMT', 'allogenic or autologous FMT', 'Allogenic FMT']","['HOMA-IR or hepatic PDFF', 'Patient visits', 'intestinal permeability', 'insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability', 'small intestinal permeability', 'HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",21.0,0.0335215,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Craven', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nair Parvathy', 'Affiliation': ""Division of Infectious Disease, St. Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Beaton', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Silverman', 'Affiliation': 'Program in Computational Biology and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Qumosani', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hegele', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Tisha', 'Initials': 'T', 'LastName': 'Joy', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Meddings', 'Affiliation': 'Department of Medicine, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Urquhart', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Harvie', 'Affiliation': 'The Canadian Centre for Microbiome and Probiotic Research, London, Ontario, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McKenzie', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Reid', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Burton', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000661']
2698,31154313,"Peer reviewed evaluation of registered end-points of randomised trials (the PRE-REPORT study): protocol for a stepped-wedge, cluster-randomised trial.","INTRODUCTION


Clinical trials are critical to the advancement of medical knowledge. However, the reliability of trial conclusions depends in part on consistency between pre-planned and reported study outcomes. Unfortunately, selective outcome reporting, in which outcomes reported in published manuscripts differ from pre-specified study outcomes, is common. Trial registries such as ClinicalTrials.gov have the potential to help identify and stop selective outcome reporting during peer review by allowing peer reviewers to compare outcomes between registry entries and submitted manuscripts. However, the persistently high rate of selective outcome reporting among published clinical trials indicates that the current peer review process at most journals does not effectively address the problem of selective outcome reporting.
METHODS AND ANALYSIS


PRE-REPORT is a stepped-wedge cluster-randomised trial that will test whether providing peer reviewers with a summary of registered, pre-specified primary trial outcomes decreases inconsistencies between prospectively registered and published primary outcomes. Peer reviewed manuscripts describing clinical trial results will be included. Eligible manuscripts submitted to each participating journal during the study period will comprise each cluster. After an initial control phase, journals will transition to the intervention phase in random order, after which peer reviewers will be emailed registry information consisting of the date of registration and any prospectively defined primary outcomes. Blinded outcome assessors will compare registered and published primary outcomes for all included trials. The primary PRE-REPORT outcome is the presence of a published primary outcome that is consistent with a prospectively defined primary outcome in the study's trial registry. The primary outcome will be analysed using a mixed effect logistical regression model to compare results between the intervention and control phases.
ETHICS AND DISSEMINATION


The Cooper Health System Institutional Review Board determined that this study does not meet criteria for human subject research. Findings will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ISRCTN41225307; Pre-results.",2019,Trial registries such as ClinicalTrials.gov have the potential to help identify and stop selective outcome reporting during peer review by allowing peer reviewers to compare outcomes between registry entries and submitted manuscripts.,[],[],[],[],[],[],,0.22975,Trial registries such as ClinicalTrials.gov have the potential to help identify and stop selective outcome reporting during peer review by allowing peer reviewers to compare outcomes between registry entries and submitted manuscripts.,"[{'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Jones', 'Affiliation': 'Emergency Medicine, Cooper Medical School of Rowan University, Camden, New Jersey, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'Medical Library, Cooper Medical School of Rowan University, Camden, New Jersey, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Weaver', 'Affiliation': 'Mathematics and Statistics, Elon University, Elon, North Carolina, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schroter', 'Affiliation': 'BMJ Editorial, London, UK.'}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Misemer', 'Affiliation': 'Emergency Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schriger', 'Affiliation': 'Emergency Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Platts-Mills', 'Affiliation': 'University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, USA.'}]",BMJ open,['10.1136/bmjopen-2018-028694']
2699,32428648,Hickman central venous catheters in children: open versus percutaneous technique.,"BACKGROUND


The ideal technique for insertion of tunneled central venous catheters (CVCs) in children is still debatable. This study aimed to compare the outcomes of open versus percutaneous technique for the insertion of tunneled CVCs.
METHODS


The study included 279 patients who had CVCs insertions from 2010 to 2020. Patients were divided into two groups according to the technique of insertion; group 1 (n= 90) included patients who had the open cut-down method, and group 2 (n= 189) included patients who had the percutaneous technique.
RESULTS


There was no difference in age and gender distribution between groups (p= 0.152 and 0.102, respectively). Chemotherapy was the most common indication of insertion (77 (85.56%) vs. 165 (87.30%); in group 1 vs. 2, p= 0.688). The left external jugular was the most common site of insertion in group 1 (n= 66; 73.33%), and the left subclavian was the most common site in group 2 (n= 77; 40.74%). Complications of insertion were non-significantly higher in group 2 (p= 0.170). Nine patients in group 2 required conversion to cut-down technique (4.76%). Complications during removal were non-significantly higher in group 2 (p= 0.182) and the most common was bleeding (n= 4; 2.12%). The most common indication for catheter removal was the completion of the treatment (36 (40%) vs. 85 (44.97%) in groups 1 and 2; respectively).
CONCLUSION


Percutaneous and open tunneled central venous catheter insertion are safe in pediatric patients who require long-term venous access. Both techniques have a low complication rate. The choice of each method should be tailored to the condition of each patient.",2020,Complications during removal were non-significantly higher in group 2 (p= 0.182) and the most common was bleeding (n= 4; 2.12%).,"['279 patients who had CVCs insertions from 2010 to 2020', 'Patients were divided into two groups according to the technique of insertion; group 1 (n= 90) included patients who had the open cut-down method, and group 2 (n= 189) included patients who had the percutaneous technique', 'pediatric patients who require long-term venous access', 'children']","['tunneled central venous catheters (CVCs', 'Percutaneous and open tunneled central venous catheter insertion', 'Chemotherapy', 'Hickman central venous catheters', 'open versus percutaneous technique', 'percutaneous technique']","['Complications during removal', 'conversion to cut-down technique', 'catheter removal', 'Complications of insertion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0457431', 'cui_str': 'Percutaneous techniques'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0457431', 'cui_str': 'Percutaneous techniques'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",279.0,0.0687854,Complications during removal were non-significantly higher in group 2 (p= 0.182) and the most common was bleeding (n= 4; 2.12%).,"[{'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Bawazir', 'Affiliation': 'Consultant Pediatric surgery and Pediatric urology King Faisal Specialist Hospital & Research Centre, Dept. of surgery KSA, Jeddah 21499, P.O.box 40047, MBC: j-40. Electronic address: obawazir@yahoo.com.'}, {'ForeName': 'Tariq I', 'Initials': 'TI', 'LastName': 'Altokhais', 'Affiliation': 'Associate professor department of pediatric College of medicine , King Saud University, Consultant Pediatric Surgeon.'}]",Annals of vascular surgery,['10.1016/j.avsg.2020.04.059']
2700,31969713,Correction to: Effectiveness and tolerability of lidocaine 5% spray in the treatment of lifelong premature ejaculation patients: a randomized single-blind placebo-controlled clinical trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['lifelong premature ejaculation patients'],"['lidocaine', 'placebo']",['Effectiveness and tolerability'],"[{'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0706763,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Mohammed Abu', 'Initials': 'MA', 'LastName': 'El-Hamd', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University, Sohag, Egypt. mohammedadva@yahoo.com.'}]",International journal of impotence research,['10.1038/s41443-020-0229-5']
2701,32429063,Probiotic NVP-1703 Alleviates Allergic Rhinitis by Inducing IL-10 Expression: A Four-week Clinical Trial.,"Although several recent studies reported that probiotics might be beneficial for allergic rhinitis (AR), the effect of probiotics on AR is not consistent and have not been reproduced between studies. We aimed to determine the efficacy and safety of probiotic NVP-1703, a mixture of  Bifidobacterium longum  and  Lactobacillus plantarum , in subjects with perennial AR. Adult subjects with perennial AR received either NVP-1703 ( n  = 47) or placebo ( n  = 48) for four weeks. Total nasal symptom scores (TNSS), rhinitis control assessment test (RCAT), blood eosinophil count, allergen-specific IgE, and immunological parameters in serum and urine were compared at baseline and after four weeks. TNSS changes from baseline at weeks 1, 3, and 4 were significant between the NVP-1703 and placebo groups ( p  = 0.033, 0.031, and 0.029, respectively). RCAT score showed significant differences between the NVP-1703 and placebo groups ( p  = 0.049) at week 4.  Dermatophagoides farinae -specific IgE levels and serum IL-10 levels were significantly different between the NVP-1703 and placebo groups ( p  = 0.033 and  p  = 0.047, respectively). IL-10/IL-4 and IL-10/IL-13 ratios were different between the NVP-1703 and placebo groups at week 4 ( p  = 0.046 and 0.018, respectively). NVP-1703 treatment reduced urinary prostaglandin F 2α  and leukotriene E 4  levels ( p  > 0.05). Therefore, NVP-1703 can be treatment option for perennial AR.",2020,NVP-1703 treatment reduced urinary prostaglandin F 2α  and leukotriene E 4  levels ( p  > 0.05).,"['subjects with perennial AR', 'Alleviates Allergic Rhinitis by Inducing IL-10 Expression', 'Adult subjects with perennial AR']","['Probiotic NVP-1703', 'probiotic NVP-1703, a mixture of  Bifidobacterium longum  and  Lactobacillus plantarum', 'NVP-1703', 'NVP-1703 and placebo', 'placebo']","['RCAT score', 'Dermatophagoides farinae -specific IgE levels and serum IL-10 levels', 'TNSS changes', 'Total nasal symptom scores (TNSS), rhinitis control assessment test (RCAT), blood eosinophil count, allergen-specific IgE, and immunological parameters in serum and urine', 'IL-10/IL-4 and IL-10/IL-13 ratios', 'urinary prostaglandin F 2α  and leukotriene E 4  levels']","[{'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0323677', 'cui_str': 'Dermatophagoides farinae'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0443736', 'cui_str': 'Allergen specific immunoglobulin E'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033561', 'cui_str': 'F series prostaglandin'}, {'cui': 'C0125644', 'cui_str': 'LTE4'}]",,0.0815145,NVP-1703 treatment reduced urinary prostaglandin F 2α  and leukotriene E 4  levels ( p  > 0.05).,"[{'ForeName': 'Min-Gyu', 'Initials': 'MG', 'LastName': 'Kang', 'Affiliation': 'Department of Allergy and Clinical Immunology, Chungbuk National University Hospital, Cheongju 28644, Korea.'}, {'ForeName': 'Seung-Won', 'Initials': 'SW', 'LastName': 'Han', 'Affiliation': 'PB Business Department, Navipharm Inc., Suwon 16209, Korea.'}, {'ForeName': 'Hye-Ryun', 'Initials': 'HR', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Division of Allergy and Clinical Immunology, Seoul National University Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Seok-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Hallym University Dongtan Sacred Heart Hospital, Hwaseong 18450, Korea.'}, {'ForeName': 'Dong-Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Neurobiota Research Center, College of Pharmacy, Kyung Hee University, Seoul 02453, Korea.'}, {'ForeName': 'Jeong-Hee', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Allergy and Clinical Immunology Research Center, Hallym University College of Medicine, Chuncheon 24252, Korea.'}]",Nutrients,['10.3390/nu12051427']
2702,31720819,Post-stroke cognitive impairment as an independent predictor of ischemic stroke recurrence: PICASSO sub-study.,"INTRODUCTION


To devise appropriate preventive strategies after stroke, knowledge of the association between post-stroke cognitive impairment (PSCI) and prognosis of stroke patients is important. We investigated the association between PSCI and the vascular outcomes in patients with ischemic stroke with best medical care considering their risk factors and adherence to medications.
METHODS


Of the 1534 ischemic stroke patients who randomly assigned to aspirin or cilostazol treatment with best medical therapy by the PICASSO (PreventIon of CArdiovascular events in iSchemic Stroke patients with high risk of cerebral hemOrrhage) trial, 1240 with baseline mini-mental state examination (MMSE) scores were analysed retrospectively. The patients were classified into three groups based on MMSE scores. Recurrence of ischemic stroke, stroke of any type and composite of major vascular events were compared among them.
RESULTS


Of the 1240 patients, 376 had MMSE scores of 28-30 (highest tertile), 419 had scores of 24-27 (middle tertile) and 445 had scores of 0-23 (lowest tertile). The average time from stroke onset to MMSE examination was 31.8 days. By trend analysis, lower tertile of MMSE score was significantly associated with recurrent ischemic stroke (p = 0.0017), stroke of any type (p = 0.0053) and composite vascular outcome (p = 0.0122). After adjustment for covariates, PSCI was independently associated with risk of recurrent ischemic stroke (HR 2.40, 95% confidence interval 1.12-5.14).
CONCLUSIONS


Cognitive impairment was associated with recurrence of ischemic stroke in high risk patients during adequate medical therapy including antiplatelet therapy. However, the other vascular events were not.",2020,"By trend analysis, lower tertile of MMSE score was significantly associated with recurrent ischemic stroke (p = 0.0017), stroke of any type (p = 0.0053) and composite vascular outcome (p = 0.0122).","['patients with ischemic stroke with best medical care considering their risk factors and adherence to medications', 'iSchemic Stroke patients with high risk of cerebral hemOrrhage) trial, 1240 with baseline mini-mental state examination', '1240 patients', 'Of the 1534 ischemic stroke patients who randomly assigned to']",['aspirin or cilostazol treatment with best medical therapy by the PICASSO (PreventIon of CArdiovascular events'],"['Recurrence of ischemic stroke, stroke of any type and composite of major vascular events', 'MMSE) scores', 'risk of recurrent ischemic stroke', 'composite vascular outcome', 'MMSE score', 'stroke of any type', 'recurrent ischemic stroke', 'MMSE scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]",1240.0,0.097577,"By trend analysis, lower tertile of MMSE score was significantly associated with recurrent ischemic stroke (p = 0.0017), stroke of any type (p = 0.0053) and composite vascular outcome (p = 0.0122).","[{'ForeName': 'Hyuk Sung', 'Initials': 'HS', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Hanyang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dongwhane', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Min Hwan', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Sungwook', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Sung', 'Initials': 'JS', 'LastName': 'Lim', 'Affiliation': 'Department of Neurology, Hallym Neurological Institute, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Kyung-Ho', 'Initials': 'KH', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Hallym Neurological Institute, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Mi Sun', 'Initials': 'MS', 'LastName': 'Oh', 'Affiliation': 'Department of Neurology, Hallym Neurological Institute, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Ji-Sung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Keun-Sik', 'Initials': 'KS', 'LastName': 'Hong', 'Affiliation': 'Department of Neurology, Ilsan Paik Hospital, Inje University, Goyang, Republic of Korea.'}, {'ForeName': 'Eun-Jae', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Dong-Wha', 'Initials': 'DW', 'LastName': 'Kang', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Sun U', 'Initials': 'SU', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea. sukwon@amc.seoul.kr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-019-09630-4']
2703,31461138,Effect of Low-Dose Supplementation of Arginine Vasopressin on Need for Blood Product Transfusions in Patients With Trauma and Hemorrhagic Shock: A Randomized Clinical Trial.,"Importance


Current therapies for traumatic blood loss focus on hemorrhage control and blood volume replacement. Severe hemorrhagic shock, however, is associated with a state of arginine vasopressin (AVP) deficiency, and supplementation of this hormone may decrease the need for blood products in resuscitation.
Objective


To determine whether low-dose supplementation of AVP in patients with trauma (hereinafter referred to as trauma patients) and with hemorrhagic shock decreases their need for transfused blood products during resuscitation.
Design, Setting, and Participants


This randomized, double-blind placebo-controlled clinical trial included adult trauma patients (aged 18-65 years) who received at least 6 U of any blood product within 12 hours of injury at a single urban level 1 trauma center from May 1, 2013, through May 31, 2017. Exclusion criteria consisted of prehospital cardiopulmonary resuscitation, emergency department thoracotomy, corticosteroid use, chronic renal insufficiency, coronary artery disease, traumatic brain injury requiring any neurosurgical intervention, pregnancy, prisoner status, or AVP administration before enrollment. Data were analyzed from May 1, 2013, through May 31, 2017, using intention to treat and per protocol.
Interventions


After administration of an AVP bolus (4 U) or placebo, participants received AVP (≤0.04 U/min) or placebo for 48 hours to maintain a mean arterial blood pressure of at least 65 mm Hg.
Main Outcomes


The primary outcome was total volume of blood product transfused. Secondary end points included total volume of crystalloid transfused, vasopressor requirements, secondary complications, and 30-day mortality.
Results


One hundred patients underwent randomization (49 to the AVP group and 51 to the placebo group). Patients were primarily young (median age, 27 years [interquartile range {IQR}, 22-25 years]) and male (n = 93) with penetrating trauma (n = 79). Cohort characteristics before randomization were well balanced. At 48 hours, patients who received AVP required significantly less blood products (median, 1.4 [IQR, 0.5-2.6] vs 2.9 [IQR, 1.1-4.8] L; P = .01) but did not differ in requirements for crystalloids (median, 9.9 [IQR, 7.9-13.0] vs 11.0 [8.9-15.0] L; P = .22) or vasopressors (median, 400 [IQR, 0-5900] vs 1400 [IQR, 200-7600] equivalent units; P = .22). Although the groups had similar rates of mortality (6 of 49 [12%] vs 6 of 51 [12%]; P = .94) and total complications (24 of 44 [55%] vs 30 of 47 [64%]; P = .37), the AVP group had less deep venous thrombosis (5 of 44 [11%] vs 16 of 47 [34%]; P = .02).
Conclusions and Relevance


Low-dose AVP during the resuscitation of trauma patients in hemorrhagic shock decreases blood product requirements. Additional research is necessary to determine whether including AVP improves morbidity or mortality.
Trial Registration


ClinicalTrials.gov identifier: NCT01611935.",2019,"At 48 hours, patients who received AVP required significantly less blood products (median, 1.4 [IQR, 0.5-2.6] vs 2.9 [IQR, 1.1-4.8] L; P = .01) but did not differ in requirements for crystalloids (median, 9.9 [IQR, 7.9-13.0] vs 11.0 [8.9-15.0] L; P = .22) or vasopressors (median, 400 [IQR, 0-5900] vs 1400 [IQR, 200-7600] equivalent units; P = .22).","['Patients With Trauma and Hemorrhagic Shock', 'patients with trauma', 'adult trauma patients (aged 18-65 years) who received at least 6 U of any blood product within 12 hours of injury at a single urban level 1 trauma center from May 1, 2013, through May 31, 2017', 'Exclusion criteria consisted of prehospital cardiopulmonary resuscitation, emergency department thoracotomy, corticosteroid use, chronic renal insufficiency, coronary artery disease, traumatic brain injury requiring any neurosurgical intervention, pregnancy, prisoner status, or AVP administration before enrollment', 'Patients were primarily young (median age, 27 years [interquartile range {IQR}, 22-25 years]) and male (n\u2009=\u200993) with penetrating trauma (n\u2009=\u200979', 'One hundred patients underwent randomization (49 to the AVP group and 51 to the']","['AVP bolus (4 U) or placebo', 'AVP (≤0.04 U/min) or placebo', 'AVP', 'placebo', 'Arginine Vasopressin']","['Severe hemorrhagic shock', 'total complications', 'Blood Product Transfusions', 'total volume of crystalloid transfused, vasopressor requirements, secondary complications, and 30-day mortality', 'total volume of blood product transfused', 'deep venous thrombosis', 'rates of mortality', 'blood products']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0403447', 'cui_str': 'Renal Insufficiency, Chronic'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205321', 'cui_str': 'Penetrating (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1532693', 'cui_str': 'Units per minute'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]",100.0,0.742006,"At 48 hours, patients who received AVP required significantly less blood products (median, 1.4 [IQR, 0.5-2.6] vs 2.9 [IQR, 1.1-4.8] L; P = .01) but did not differ in requirements for crystalloids (median, 9.9 [IQR, 7.9-13.0] vs 11.0 [8.9-15.0] L; P = .22) or vasopressors (median, 400 [IQR, 0-5900] vs 1400 [IQR, 200-7600] equivalent units; P = .22).","[{'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Sims', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Holena', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kim', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Pascual', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Neils', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Seamon', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Shiroff', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Shariq', 'Initials': 'S', 'LastName': 'Raza', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Kaplan', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Grill', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Mason', 'Affiliation': 'Department of Anesthesia, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Abella', 'Affiliation': 'Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Reilly', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}]",JAMA surgery,['10.1001/jamasurg.2019.2884']
2704,31520695,Outcomes of Resectability Assessment of the Dutch Colorectal Cancer Group Liver Metastases Expert Panel.,"BACKGROUND


Decision making on optimal treatment strategy in patients with initially unresectable colorectal cancer liver metastases (CRLM) remains complex because uniform criteria for (un)resectability are lacking. This study reports on the feasibility and short-term outcomes of The Dutch Colorectal Cancer Group Liver Expert Panel.
STUDY DESIGN


The Expert Panel consists of 13 hepatobiliary surgeons and 4 radiologists. Resectability assessment is performed independently by 3 randomly assigned surgeons, and CRLM are scored as resectable, potentially resectable, or permanently unresectable. In absence of consensus, 2 additional surgeons are invited for a majority consensus. Patients with potentially resectable or unresectable CRLM at baseline are evaluated every 2 months of systemic therapy. Once CRLM are considered resectable, a treatment strategy is proposed.
RESULTS


Overall, 398 panel evaluations in 183 patients were analyzed. The median time to panel conclusion was 7 days (interquartile range [IQR] 5-11 days). Intersurgeon disagreement was observed in 205 (52%) evaluations, with major disagreement (resectable vs permanently unresectable) in 42 (11%) evaluations. After systemic treatment, 106 patients were considered to have resectable CRLM, 84 of whom (79%) underwent a curative procedure. R0 resection (n = 41), R0 resection in combination with ablative treatment (n = 26), or ablative treatment only (n = 4) was achieved in 67 of 84 (80%) patients.
CONCLUSIONS


This study analyzed prospective resectability evaluation of patients with CRLM by a panel of radiologists and liver surgeons. The high rate of disagreement among experienced liver surgeons reflects the complexity in defining treatment strategies for CRLM and supports the use of a panel rather than a single-surgeon decision.",2019,The median time to panel conclusion was 7 days (IQR 5-11).,"['398 panel evaluations in 183 patients were analyzed', 'patients with CRLM by a panel of radiologists and liver surgeons', 'patients with initially unresectable colorectal cancer liver metastases (CRLM', '106 patients were considered to have resectable CRLM, out of which 84 (79%) patients underwent a curative procedure', 'Dutch Colorectal Cancer Group Liver Expert Panel', 'Patients with potentially resectable or unresectable CRLM at baseline are evaluated every two months of systemic therapy']",['R0 resection (n=41) or R0 resection in combination with ablative treatment'],['Resectability assessment'],"[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0260194', 'cui_str': 'Radiologist (occupation)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1880609', 'cui_str': 'Every two months (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",398.0,0.0327097,The median time to panel conclusion was 7 days (IQR 5-11).,"[{'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Huiskens', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands; Department of Medical Oncology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bolhuis', 'Affiliation': 'Department of Medical Oncology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: k.bolhuis@amsterdamumc.nl.'}, {'ForeName': 'Marc Rw', 'Initials': 'MR', 'LastName': 'Engelbrecht', 'Affiliation': 'Department of Radiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Koert P', 'Initials': 'KP', 'LastName': 'De Jong', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Kazemier', 'Affiliation': 'Department of Surgery, Amsterdam UMC, VU University, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Mike Sl', 'Initials': 'MS', 'LastName': 'Liem', 'Affiliation': 'Department of Surgery, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Verhoef', 'Affiliation': 'Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Johannes Hw', 'Initials': 'JH', 'LastName': 'de Wilt', 'Affiliation': 'Department of Surgery, Radboud UMC, Nijmegen, The Netherlands.'}, {'ForeName': 'Cornelis Ja', 'Initials': 'CJ', 'LastName': 'Punt', 'Affiliation': 'Department of Medical Oncology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'van Gulik', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2019.08.1445']
2705,32428747,A synergistic effect between family intervention and rTMS improves cognitive and negative symptoms in schizophrenia: A randomized controlled trial.,"OBJECTIVE


The present study explored an efficient new therapy that combined repetitive transcranial magnetic stimulation (rTMS) and family intervention in addition to risperidone to improve schizophrenia.
METHODS


A randomized controlled trial (January 2016-September 2017) involving 200 patients, of which 188 patients completed the 12-week study, and 50 controls were conducted in the research. The patients were randomly assigned to 12 weeks of treatment with risperidone alone (risperidone group), rTMS and risperidone (rTMS group), family intervention and risperidone (family intervention group), rTMS and risperidone plus family intervention (combined group). MATRICS Consensus Cognitive Battery (MCCB) and the Positive and Negative Symptoms Scale (PANSS) were used to evaluate treatment efficacy. Repeated measures analysis of variance (RMANOVA) were performed to evaluate different treatment efficacy between four groups after 12 weeks of treatment.
RESULTS


(1) There were no significant differences in sex, age, education, cognitive function, or PANSS scores between the four groups at baseline (p's > 0.05). (2) There was a significant decrease in the PANSS scores and an increase in the MCCB scores after 12 weeks of treatment in all groups (time effect p's < 0.001). (3) The improvements in positive symptoms and negative symptoms were more obvious in the combined group than in other groups (p's < 0.05). (4) The combined group showed the superior effect in cognition function after 12 weeks. (5) And, interestingly, a remarkable synergistic effect between rTMS and family intervention therapy was observed.
CONCLUSION


There was a synergistic effect between rTMS and the family intervention as an effective combined therapy in improving schizophrenia. This study is registered with Chictr.org, number ChiCTR1900024422 (http://www.chictr.org.cn/edit.aspx?pid=34285&htm=4).",2020,The improvements in positive symptoms and negative symptoms were more obvious in the combined group than in other groups (,"['schizophrenia', '200 patients, of which 188 patients completed the 12-week study, and 50 controls were conducted in the research']","['risperidone', 'combined repetitive transcranial magnetic stimulation (rTMS', 'risperidone alone (risperidone group), rTMS and risperidone (rTMS group), family intervention and risperidone (family intervention group), rTMS and risperidone plus family intervention (combined group', 'rTMS']","['sex, age, education, cognitive function, or PANSS scores', 'MCCB scores', 'positive symptoms and negative symptoms', 'PANSS scores', 'Consensus Cognitive Battery (MCCB) and the Positive and Negative Symptoms Scale (PANSS', 'cognitive and negative symptoms', 'cognition function']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",200.0,0.0287929,The improvements in positive symptoms and negative symptoms were more obvious in the combined group than in other groups (,"[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xiuxia', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yulin', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Department of Biomedical Engineering, College of Engineering, Peking University, Beijing, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Supervision Bureau of the Health and Family Planning Commission, Wancheng District, Nanyang City, China.'}, {'ForeName': 'Qiyue', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Luxian', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Henan Province Mental Hospital, The Second Affiliated Hospital, Xinxiang Medical University, Xinxiang, China.'}, {'ForeName': 'Xu-Feng', 'Initials': 'XF', 'LastName': 'Huang', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Medicine, University of Wollongong, NSW2522, Australia. Electronic address: xhuang@uow.edu.au.'}, {'ForeName': 'Xueqin', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'The First Affiliated Hospital/Zhengzhou University, Zhengzhou, China; Biological Psychiatry International Joint Laboratory of Henan, Zhengzhou University, Zhengzhou, China; Henan Psychiatric Transformation Research Key Laboratory, Zhengzhou University, Zhengzhou, China. Electronic address: fccsongxq@zzu.edu.cn.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.04.009']
2706,17539888,Breastfeeding Best Start study: training midwives in a 'hands off' positioning and attachment intervention.,"The most common reasons cited by women for giving up breastfeeding early can be attributed to ineffective positioning and attachment and are therefore preventable. This study aimed to determine whether a 4-h training programme in 'hands off' positioning and attachment support increases midwives' knowledge and problem-solving skills. Using an unrelated comparison group and a pre- and post-intervention design, 108 midwives (experimental group) completed a 4-h standard breastfeeding training workshop focusing on effective positioning and attachment and the use of hands-off teaching methods. Knowledge and problem-solving skills were assessed using a modified form of the previously validated Breastfeeding Support Skills Tool. Pre- and post-training scores were compared with those of 27 student midwives (control group) who undertook the same assessments but without the breastfeeding training. Baseline knowledge scores of the midwives and the student midwives did not differ significantly (average difference 0.7 points to qualified midwives' advantage, 95% CI = -3.4 to 1.9). Following training, the qualified midwives' total scores increased significantly (7.2 points, 95% CI = 6.2-8.2). Minimal changes (1.4 points, 95% CI = -0.15 to 2.9) in students' scores were found. The additional increase owing to training above that which might be expected due to practice (i.e. the average difference in change scores between the two groups) was 5.8 points (95% CI = 3.75-7.96), representing a large effect size for the training (d = 0.95). There is a large variation in the breastfeeding knowledge of midwives working in post-natal care and, on average, they are no more skilled than senior student midwives. The study has shown that a 4-h workshop in a positioning and attachment intervention, using a 'hands-off' approach, can increase midwives' knowledge of breastfeeding support relevant to the immediate post-natal period. It is applicable to all midwives, and could be a cost-effective way of improving the ability of mothers to begin and continue to breastfeed successfully.",2007,"Following training, the qualified midwives' total scores increased significantly (7.2 points, 95% CI = 6.2-8.2).",[],['108 midwives (experimental group) completed a 4-h standard breastfeeding training workshop focusing on effective positioning and attachment and the use of hands-off teaching methods'],"['Baseline knowledge scores', ""qualified midwives' total scores""]",[],"[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0357526,"Following training, the qualified midwives' total scores increased significantly (7.2 points, 95% CI = 6.2-8.2).","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Law', 'Affiliation': 'Department of Nursing, Midwifery and Health Care, Coventry University, Coventry, UK. s.law@coventry.ac.uk'}, {'ForeName': 'Orla M', 'Initials': 'OM', 'LastName': 'Dunn', 'Affiliation': ''}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Wallace', 'Affiliation': ''}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Inch', 'Affiliation': ''}]",Maternal & child nutrition,[]
2707,32428843,Aquatic exercising may improve sexual function in females with multiple sclerosis - an exploratory study.,"BACKGROUND


Persons with multiple sclerosis (PwMS) report impaired sexual function, and this is particularly prevalent and burdensome for females with MS. The present study included a randomized controlled trial (RCT) design and examined the effect of aquatic exercise training on sexual function among females with MS.
METHODS


The sample consisted of 60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75) who were randomly assigned into one of the following conditions: aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC). Participants completed questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction before and after the 8-week study period.
RESULTS


The interventions had significant and positive effects on the overall score of sexual function (p < .001, η ρ 2  = .35), all subscales (desire (p = .002, 2 = .20), arousal (p = .01, 2 =.15), lubrication (p = .011, 2 = .15), orgasm (p = .007, 2 = .16), satisfaction (p = .023, 2 = .13), pain (p = .02, 2 = .13)) and depression (p =.002, 2 = .20).The interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
CONCLUSIONS


Aquatic exercise training may improve sexual function among female PwMS, but this requires further examination using a large sample pre-screened for sexual dysfunction. If confirmed, the present findings are of clinical and practical importance for females with MS.",2020,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
","['Persons with multiple sclerosis (PwMS', 'females with multiple sclerosis', 'females with MS.\nMETHODS', 'females with MS', '60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75']","['Aquatic exercise training', 'aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC', 'aquatic exercise training', 'Aquatic exercising']","['arousal', 'overall score of sexual function', 'fatigue', 'sleep complaints', 'couple satisfaction', 'questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction', 'sexual function', 'satisfaction', 'pain', 'depression', 'lubrication']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C4517514', 'cui_str': '1.75'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",60.0,0.044883,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition.
","[{'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran. Electronic address: dena.sadeghibahmani@upk.ch.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Razazian', 'Affiliation': 'Kermanshah University of Medical Sciences, Neurology Department, Kermanshah, Iran.'}, {'ForeName': 'Habibolah', 'Initials': 'H', 'LastName': 'Khazaie', 'Affiliation': 'Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran; Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Health Institute, Kermanshah, Iran; University of Basel, Department of Sport, Exercise, and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Tehran University of Medical Sciences, School of Medicine, Tehran, Iran.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102106']
2708,32428959,Dresdener Network Osteoporosis.,"PURPOSE


On a global scale the main focus of traumatological therapy lies in the treatment of unintentional injuries or victims of violence. People of all ages and through all economic groups can be affected. Due to demographic change in Western industrial countries, however, this focus increasingly shifts towards fragility fractures. In Europe osteoporosis is the most common bone disease in advanced age. Secondary prevention programs like the Fracture Liaison Service (FLS) are becoming increasingly prevalent, especially in Anglo-American health care systems. In German orthopedic and trauma wards and hospitals, however, the FLS is still relatively uncommon. This article will examine the question whether secondary prevention programs like FLS need to be established in the German health care system. This study aims at finding out, whether in the area of a medium sized German city there is a difference regarding the initiation of osteoporosis diagnosis and therapy between the regular aftercare by the general practitioner or the orthopedic surgeon and the aftercare by a specialist trained in osteology (Osteologe).
MATERIALS AND METHODS


For the open, randomized prospective study 70 patients with low energy fractures were recruited, who were older than 60 years and have been treated in our department.
RESULTS


58 out of 70 patients have completed the study, which amounts to a follow-up of 82.9%. Limited mobility and a high degree of organizational effort were the main reasons for early termination of the study. While in the group with regular aftercare, only 2 out of 29 patients received a specific osteoporosis treatment, in group who were directly transferred to a specialist trained in osteology 17 out of 29 patients received specific treatment. After re-evaluation of group with regular aftercare in 21 out of 29 cases a specific osteoporosis treatment was recommended.
CONCLUSIONS


It could be established that there is a significant diagnosis and treatment gap regarding the aftercare of patients with fractures caused by osteoporosis between general practitioners or orthopedic surgeons on the one hand and the specialists trained in osteology on the other hand. To improve the aftercare of fracture patients, cross sectoral networks with a background in geriatrics and orthopedic-trauma surgery like a FLS need to be established in the German healthcare system.",2020,"Secondary prevention programs like the Fracture Liaison Service (FLS) are becoming increasingly prevalent, especially in Anglo-American health care systems.","['70 patients with low energy fractures were recruited, who were older than 60 years and have been treated in our department', '58 out of 70 patients', 'unintentional injuries or victims of violence']","['Fracture Liaison Service (FLS', 'specific treatment', 'specific osteoporosis treatment']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0151736', 'cui_str': 'Accidental injury'}, {'cui': 'C0042693', 'cui_str': 'Violence'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4303745', 'cui_str': 'Treatment for osteoporosis'}]",[],70.0,0.0352955,"Secondary prevention programs like the Fracture Liaison Service (FLS) are becoming increasingly prevalent, especially in Anglo-American health care systems.","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Fülling', 'Affiliation': 'Department of Trauma, Reconstructive and Hand Surgery, Dresden Municipal Hospital.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Bula', 'Affiliation': 'Department of Trauma and Reconstructive Surgery, Orthopaedic, Plastic, Aesthetic and Hand Surgery, Gutersloh Municipal Hospital.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Defèr', 'Affiliation': 'General Medicine, Private Practice, Dresden.'}, {'ForeName': 'Felix Alois', 'Initials': 'FA', 'LastName': 'Bonnaire', 'Affiliation': 'Department of Trauma, Reconstructive and Hand Surgery, Dresden Municipal Hospital.'}]",Zeitschrift fur Orthopadie und Unfallchirurgie,['10.1055/a-1149-9588']
2709,32048596,Yoga versus educational film intervention in restless legs syndrome: extension of trial may be beneficial to patients.,,2020,,['restless legs syndrome'],['Yoga versus educational film intervention'],[],"[{'cui': 'C3887611', 'cui_str': 'Restlessness (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C4319646', 'cui_str': 'Film'}]",[],,0.0791257,,"[{'ForeName': 'Mahadevappa', 'Initials': 'M', 'LastName': 'Hunasikatti', 'Affiliation': 'Sleep Medicine Branch, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8366']
2710,32428937,"Phenolic-rich Pomegranate Peel Extract: In Vitro, Cellular, and In Vivo Activities for Skin Hyperpigmentation Treatment.","The pomegranate phenolics are reported to have cutaneous benefits and to be effective in treating skin disorders, including hyperpigmentation. In this context, a preparation method was developed by which to obtain phenolic-rich pomegranate peel extract. Sinapic acid was presented as the major pomegranate peel phenolics, followed by gallic and ellagic acids, and 4 additional phenolics. The extract exhibited strong antioxidant activity with an  in vitro  tyrosinase inhibitory effect. The skin hyperpigmentation treating potency was confirmed by the suppression of cellular melanogenesis through tyrosinase and TRP-2 inhibitions as examined in the B16F10 melanoma cells. Cellular antioxidant and proliferative activities of the extract toward human dermal fibroblasts were evidenced, as well as an inhibitory effect against MMP-2. The extract was developed into the stable serum and mask. The products were proved to be non-irritated in 30 Thai volunteers participating in a single application closed patch test. A split-face, randomized, double-blind, placebo-controlled test of the skin lightening effect was evaluated in the 30 volunteers over 28 consecutive daily treatments and monitored by the Mexameter MX 18. The active serum and mask were better in facial skin lightening efficacy than the placebo (p < 0.005). That was in accordance with the sensory evaluation scored by the volunteers. Phenolic-rich pomegranate peel extract is evidenced as a safe herbal derived material promising for skin hyperpigmentation treatment. Supportive information regarding chemical and biological profiles is presented with the confirmed safety and cutaneous benefits in volunteers.",2020,The active serum and mask were better in facial skin lightening efficacy than the placebo (p < 0.005).,"['volunteers', '30 volunteers over 28 consecutive daily treatments and monitored by the Mexameter MX 18', '30 Thai volunteers participating in a single application closed patch test']","['Phenolic-rich Pomegranate Peel Extract', 'Phenolic-rich pomegranate peel extract', 'placebo']","['facial skin lightening efficacy', 'Cellular antioxidant and proliferative activities']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0030646', 'cui_str': 'Patch test'}]","[{'cui': 'C0359916', 'cui_str': 'Substance with phenol structure'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1509685', 'cui_str': 'POMEGRANATE FRUIT EXTRACT'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C1306868', 'cui_str': 'Lightening of fetus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",30.0,0.0547414,The active serum and mask were better in facial skin lightening efficacy than the placebo (p < 0.005).,"[{'ForeName': 'Mayuree', 'Initials': 'M', 'LastName': 'Kanlayavattanakul', 'Affiliation': 'School of Cosmetic Science, Mae Fah Luang University, Chiang Rai, Thailand.'}, {'ForeName': 'Wichayada', 'Initials': 'W', 'LastName': 'Chongnativisit', 'Affiliation': 'School of Cosmetic Science, Mae Fah Luang University, Chiang Rai, Thailand.'}, {'ForeName': 'Puxvadee', 'Initials': 'P', 'LastName': 'Chaikul', 'Affiliation': 'School of Cosmetic Science, Mae Fah Luang University, Chiang Rai, Thailand.'}, {'ForeName': 'Nattaya', 'Initials': 'N', 'LastName': 'Lourith', 'Affiliation': 'School of Cosmetic Science, Mae Fah Luang University, Chiang Rai, Thailand.'}]",Planta medica,['10.1055/a-1170-7785']
2711,32428840,Acute effects of time-restricted feeding in low-income women with obesity placed on hypoenergetic diets: Randomized trial.,"OBJECTIVE


The aim of this study was to evaluate the acute effects of time-restricted feeding in obese women living in social vulnerability who were placed on diets with the same energy deficit.
METHODS


Fifty-eight obese women (19-44 y of age) were randomized to a group with a hypoenergetic diet and 12 h of fasting daily or to a group with only a hypoenergetic diet for 21 d, with body weight and waist circumference monitoring up to 81 d of intervention. The determination of the individual's energy content of the diets was based on their resting metabolic rate (by indirect calorimetry) and physical activity level (by triaxial accelerometers). Body composition, temperature, blood pressure, appetite, adhesion difficulty, thyroid axis hormones, leptin, glucose concentration, and insulin were measured before and after 21 d of intervention. A mixed analysis of variance test was performed.
RESULTS


The women had a mean age of 31 y and mean body mass index of 33 kg/m². Significant interaction between group × time was observed only in axillary temperature (0.44°C; 95% confidence interval [CI], 0.17-0.74°C; P < 0.01), which increased in the experimental group and in body fat (-0.75%; 95% CI, -1.43% to -0.07%; P = 0.02) decreased in the experimental group. Also, there was a significant decrease in waist circumference in the time-restricted feeding group after 81 d. There were no differences in hormonal profile, resting metabolic rate, reported appetite, or adherence difficulty.
CONCLUSION


Time-restricted feeding may be considered an alternative strategy for treating obesity in socially vulnerable women.",2020,"Significant interaction between group × time was observed only in axillary temperature (0.44°C; 95% confidence interval [CI], 0.17-0.74°C; P < 0.01), which increased in the experimental group and in body fat (-0.75%; 95% CI, -1.43% to -0.07%; P = 0.02) decreased in the experimental group.","['obese women living in social vulnerability who were placed on diets with the same energy deficit', 'low-income women with obesity placed on hypoenergetic diets', 'women had a mean age of 31 y and mean body mass index of 33 kg/m²', 'socially vulnerable women', 'Fifty-eight obese women (19-44 y of age']","['time-restricted feeding', 'hypoenergetic diet and 12 h of fasting daily or to a group with only a hypoenergetic diet']","['resting metabolic rate (by indirect calorimetry) and physical activity level', 'Body composition, temperature, blood pressure, appetite, adhesion difficulty, thyroid axis hormones, leptin, glucose concentration, and insulin', 'waist circumference', 'axillary temperature', 'hormonal profile, resting metabolic rate, reported appetite, or adherence difficulty', 'body fat']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1531924', 'cui_str': 'Axillary temperature'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",58.0,0.0653357,"Significant interaction between group × time was observed only in axillary temperature (0.44°C; 95% confidence interval [CI], 0.17-0.74°C; P < 0.01), which increased in the experimental group and in body fat (-0.75%; 95% CI, -1.43% to -0.07%; P = 0.02) decreased in the experimental group.","[{'ForeName': 'Isabele R O M', 'Initials': 'IROM', 'LastName': 'Pureza', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: isabelemaranhaonut@hotmail.com.'}, {'ForeName': 'Ingrid S V', 'Initials': 'ISV', 'LastName': 'Melo', 'Affiliation': 'Instituto Federal de Alagoas, Alagoas, Brazil. Electronic address: ingrid.melo@ifal.edu.br.'}, {'ForeName': 'Mateus L', 'Initials': 'ML', 'LastName': 'Macena', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: m.l.macena@hotmail.com.'}, {'ForeName': 'Dafiny R S', 'Initials': 'DRS', 'LastName': 'Praxedes', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: dafiny_rodrigues96@hotmail.com.'}, {'ForeName': 'Laís G L', 'Initials': 'LGL', 'LastName': 'Vasconcelos', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: laisglv@gmail.com.'}, {'ForeName': 'André E', 'Initials': 'AE', 'LastName': 'Silva-Júnior', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: andreeduardojr@hotmail.com.'}, {'ForeName': 'Telma M M T', 'Initials': 'TMMT', 'LastName': 'Florêncio', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: telmatf_al@hotmail.com.'}, {'ForeName': 'Nassib B', 'Initials': 'NB', 'LastName': 'Bueno', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: nassib.bueno@fanut.ufal.br.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110796']
2712,32428865,"Remdesivir in COVID-19: A critical review of pharmacology, pre-clinical and clinical studies.","BACKGROUND & AIMS


Remdesivir is a broad spectrum anti-viral drug that has shown to inhibit SARS-CoV-2, in vitro and in vivo. In absence of any effective treatment for SARS-CoV-2 infection (COVID-19), remdesivir has been tried for a compassionate use in severe COVID-19. Newer randomized controlled studies that have recently become available, showed a mixed result. We aimed to systematically search the literature to understand the pharmacology and clinical effects of remdesivir in patients with COVID-19.
METHODS


We systematically searched the PubMed, ClinicalTrial.Org and MedRxiv database up till May 5, 2020 using specific key words such as ""Remdesivir"" or 'GS-5734″ AND ""COVID-19"" or ""SARS-CoV-2"" and retrieved all the article published in English language, that have reported the pharmacology and the clinical outcomes of remdesivir in patients with COVID-19.
RESULTS


Initial compassionate use of remdesivir has shown a fairly good result, but difficult to quantify, in the absence of control arm. While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality.
CONCLUSIONS


Remdesivir has shown a mixed result in patients with COVID-19 with an acceptable side effect. However, jury is still out while awaiting the results from the forthcoming trials.",2020,"While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality.
","['Remdesivir in COVID-19', 'patients with COVID-19']",['placebo'],['mortality'],"[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.151411,"While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality.
","[{'ForeName': 'Awadhesh Kumar', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Diabetes & Endocrinology, G.D Hospital & Diabetes Institute, Kolkata, West Bengal, India. Electronic address: draksingh_2001@yahoo.com.'}, {'ForeName': 'Akriti', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'College of Medicine and JNM Hospital, Kalyani, Nadia, West Bengal, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Gynaecology & Obstetrics, G.D Hospital & Diabetes Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Fortis C-DOC Hospital for Diabetes and Allied Sciences, New Delhi, India.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.018']
2713,32428528,"Phase 2 Randomized, Double-blind Study of IL-17-Targeting with Secukinumab in Atopic Dermatitis.","CAPSULE SUMMARY


In a clinical trial of moderate-to-severe atopic dermatitis/AD patients treated with anti IL-17mAb/secukinumab, no significant clinical or molecular improvements were seen, even among disease subtypes with high Th-17-skewing (intrinsic/Asian AD).",2020,"In a clinical trial of moderate-to-severe atopic dermatitis/AD patients treated with anti IL-17mAb/secukinumab, no significant clinical or molecular improvements were seen, even among disease subtypes with high Th-17-skewing (intrinsic/Asian AD).",['Atopic Dermatitis'],"['anti IL-17mAb/secukinumab', 'IL-17-Targeting with Secukinumab']",[],"[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}]",[],,0.307103,"In a clinical trial of moderate-to-severe atopic dermatitis/AD patients treated with anti IL-17mAb/secukinumab, no significant clinical or molecular improvements were seen, even among disease subtypes with high Th-17-skewing (intrinsic/Asian AD).","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ungar', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Pavel', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kimmel', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nia', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hashim', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Hee Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Chima', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Anjali S', 'Initials': 'AS', 'LastName': 'Vekaria', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Yeriel', 'Initials': 'Y', 'LastName': 'Estrada', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Singer', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Baum', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Yasaman', 'Initials': 'Y', 'LastName': 'Mansouri', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Taliercio', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York; Department of Dermatology and the Immunology Institute, Icahn School of Medicine at Mount Sinai, New York; The Laboratory for Investigative Dermatology, The Rockefeller University, New York. Electronic address: Emma.Guttman@mountsinai.org.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.04.055']
2714,32428523,A randomized clinical trial to arrest dentin caries in young children using silver diamine fluoride.,"OBJECTIVES


The study aimed to compare the effectiveness of 38% silver diamine fluoride (SDF) solution, and 5% sodium fluoride (NaF) varnish applied semiannually in arresting dentin caries in young children with high caries risk.
METHODS


Children aged 1-3 years who had at least one active dentin carious lesion were randomly allocated into 2 groups as follows: Group 1 = 38% SDF (Topamine), and Group 2 = 5% NaF varnish (Duraphat). Both agents were applied every 6 months onto the carious surface. Lesion activity was assessed by the visual-tactile examination. Baseline and follow-up examinations were conducted by the same examiner. The children's demographic background, oral health-related habits, and oral hygiene practices, as well as parental satisfaction with children's dental appearance were collected at baseline and the 12-month follow-up.
RESULTS


At baseline, 153 and 149 children were recruited in Group 1 and Group 2, respectively. The mean dmfs scores in Groups 1 and 2 were 8.89 and 9.79, respectively. After 12 months, 87.1% remained in the study. The caries arrest rate of Group 1 (35.7%) was significantly higher than that of Group 2 (20.9%) (p <  0.001). The results of the multilevel logistic regression analysis confirmed that the treatment in Group 1 was more effective in arresting dentin carious lesions than that of Group 2 (OR = 2.04; 95% CI, 1.41-2.96). The presence of plaque on caries lesions, tooth type, tooth surface type, frequency of milk feeding, snack taking, and family income influenced on caries activity. Regardless of the intervention groups, there were no differences in parental satisfaction with on the child's dental appearance before and after receiving the intervention.
CONCLUSION


Based on the 12-month results, 38% SDF is more effective than 5% NaF varnish in arresting dentin carious lesions in young children. SDF has no negative impact on parental satisfaction with the child's dental appearance.
CLINICAL SIGNIFICANCE


To control dentin carious lesions in young children with high caries risk, 38% SDF is more effective than 5% NaF varnish.",2020,The caries arrest rate of Group 1 (35.7%) was significantly higher than that of Group 2 (20.9%) (p <  0.001).,"['young children using', 'young children', 'Children aged 1-3 years who had at least one active dentin carious lesion', 'young children with high caries risk']","['SDF', '38% silver diamine fluoride (SDF) solution, and 5% sodium fluoride (NaF) varnish', 'silver diamine fluoride', 'NaF varnish', 'SDF (Topamine), and Group 2\u2009=\u20095% NaF varnish (Duraphat']","['dentin carious lesions', 'mean dmfs scores', 'Lesion activity', 'caries arrest rate', 'dentin caries', 'effective in arresting dentin carious lesions', 'parental satisfaction', 'presence of plaque on caries lesions, tooth type, tooth surface type, frequency of milk feeding, snack taking, and family income influenced on caries activity']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0058817', 'cui_str': 'Duraphat'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0266848', 'cui_str': 'Arrested dental caries'}, {'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0447301', 'cui_str': 'Tooth surface'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021162', 'cui_str': 'Income'}]",,0.0269155,The caries arrest rate of Group 1 (35.7%) was significantly higher than that of Group 2 (20.9%) (p <  0.001).,"[{'ForeName': 'Sirinan', 'Initials': 'S', 'LastName': 'Mabangkhru', 'Affiliation': 'Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Duangporn', 'Initials': 'D', 'LastName': 'Duangthip', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chu Chun', 'Initials': 'CC', 'LastName': 'Hung', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Araya', 'Initials': 'A', 'LastName': 'Phonghanyudh', 'Affiliation': 'Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Varangkanar', 'Initials': 'V', 'LastName': 'Jirarattanasopha', 'Affiliation': 'Faculty of Dentistry, Mahidol University, Bangkok, Thailand. Electronic address: Varangkanar.jir@mahidol.ac.th.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103375']
2715,32428983,Dietary interventions for multiple sclerosis-related outcomes.,"BACKGROUND


Multiple sclerosis (MS) is a common demyelinating disease of the central nervous system. Although the exact pathogenesis remains unknown, the leading theory is that it results from immune system dysregulation. Approved disease-modifying therapy appears to modulate the immune system to improve MS-related outcomes. There is substantial interest in the ability of dietary interventions to influence MS-related outcomes. This is an update of the Cochrane Review 'Dietary interventions for multiple sclerosis' (Farinotti 2003; Farinotti 2007; Farinotti 2012).
OBJECTIVES


To assess the effects of dietary interventions (including dietary plans with recommendations for specific whole foods, macronutrients, and natural health products) compared to placebo or another intervention on health outcomes (including MS-related outcomes and serious adverse events) in people with MS.
SEARCH METHODS


On 30 May 2019, we searched CENTRAL, MEDLINE, Embase, and Web of Science. We also searched ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform (ICTRP), and Networked Digital Library of Theses and Dissertations (NDLTD). We checked reference lists in identified trials and requested information from trial authors to identify any additional published or unpublished data.
SELECTION CRITERIA


We included any randomized controlled trial (RCT) or controlled clinical trial (CCT) examining the effect of a dietary intervention versus placebo or another intervention among participants with MS on MS-related outcomes, including relapses, disability progression, and magnetic resonance imaging (MRI) measures.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane. Planned primary outcomes were number of participants experiencing relapse and change in disability progression, according to a validated disability scale at the last reported follow-up. Secondary outcomes included MRI activity, safety, and patient-reported outcomes. We entered and analysed data in Review Manager 5.
MAIN RESULTS


We found 41 full-text articles examining 30 trials following full-text review. Participants were adults with MS, defined by established criteria, presenting to MS clinics in Europe, North America, and the Middle East. Study design varied considerably, although all trials had at least one methodological issue leading to unknown or high risk of bias. Trials examined: supplementation to increase polyunsaturated fatty acids (PUFAs) (11 trials); a variety of antioxidant supplements (10 trials); dietary programmes (3 trials); and other dietary supplements (e.g. acetyl L-carnitine, biotin, creatine, palmitoylethanolamide, probiotic, riboflavin) (6 trials). In three trials comparing PUFAs with monounsaturated fatty acids (MUFAs), the evidence was very uncertain concerning difference in relapses (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.88 to 1.20; 3 studies, 217 participants; 75% in the PUFA group versus 74% in the MUFA group; very low-certainty evidence). Among four trials comparing PUFAs with MUFAs, there may be little to no difference in global impression of deterioration (RR 0.85, 95% CI 0.71 to 1.03; 4 studies, 542 participants; 40% in the PUFA group versus 47% in the MUFA group; low-certainty evidence). In two trials comparing PUFAs with MUFAs (102 participants), there was very low-certainty evidence for change in disability progression. None of the PUFA versus MUFA trials examined MRI outcomes. In one trial comparing PUFAs with MUFAs (40 participants), there were no serious adverse events; based on low-certainty evidence. In two trials comparing different PUFAs (omega-3 versus omega-6), there may be little to no difference in relapses (RR 1.02, 95% CI 0.62 to 1.66; 2 studies, 129 participants; 30% in the omega-3 versus 29% in the omega-6 group; low-certainty evidence). Among three trials comparing omega-3 with omega-6, there may be little to no difference in change in disability progression, measured as mean change in Expanded Disability Status Scale (EDSS) (mean difference (MD) 0.00, 95% CI -0.30 to 0.30; 3 studies, 166 participants; low-certainty evidence). In one trial comparing omega-3 with omega-6, there was likely no difference in global impression of deterioration (RR 0.99, 95% CI 0.51 to 1.91; 1 study, 86 participants; 29% in omega-3 versus 29% in omega-6 group; moderate-certainty evidence). In one trial comparing omega-3 with omega-6 (86 participants), there was likely no difference in number of new T1- weighted gadolinium-enhancing lesions, based on moderate-certainty evidence. In four trials comparing omega-3 with omega-6, there may be little to no difference in serious adverse events (RR 1.12, 95% CI 0.38 to 3.31; 4 studies, 230 participants; 6% in omega-3 versus 5% in omega-6 group; low-certainty evidence). In four trials examining antioxidant supplementation with placebo, there may be little to no difference in relapses (RR 0.98, 95% CI 0.59 to 1.64; 4 studies, 345 participants; 17% in the antioxidant group versus 17% in the placebo group; low-certainty evidence). In six trials examining antioxidant supplementation with placebo, the evidence was very uncertain concerning change in disability progression, measured as mean change of EDSS (MD -0.19, 95% CI -0.49 to 0.11; 6 studies, 490 participants; very low-certainty evidence). In two trials examining antioxidant supplementation with placebo, there may be little to no difference in global impression of deterioration (RR 0.99, 95% 0.50 to 1.93; 2 studies, 190 participants; 15% in the antioxidant group versus 15% in the placebo group; low-certainty evidence). In two trials examining antioxidant supplementation with placebo, the evidence was very uncertain concerning difference in gadolinium-enhancing lesions (RR 0.67, 95% CI 0.09 to 4.88; 2 studies, 131 participants; 11% in the antioxidant group versus 16% in the placebo group; very low-certainty evidence). In three trials examining antioxidant supplementation versus placebo, there may be little to no difference in serious adverse events (RR. 0.72, 95% CI 0.17 to 3.08; 3 studies, 222 participants; 3% in the antioxidant group versus 4% in the placebo group; low-certainty evidence).
AUTHORS' CONCLUSIONS


There are a variety of controlled trials addressing the effects of dietary interventions for MS with substantial variation in active treatment, comparator, and outcomes of interest. PUFA administration may not differ when compared to alternatives with regards to relapse rate, disability worsening, or overall clinical status in people with MS, but evidence is uncertain. Similarly, at present, there is insufficient evidence to determine whether supplementation with antioxidants or other dietary interventions have any impact on MS-related outcomes.",2020,"PUFA administration may not differ when compared to alternatives with regards to relapse rate, disability worsening, or overall clinical status in people with MS, but evidence is uncertain.","['people with MS', 'Participants were adults with MS, defined by established criteria, presenting to MS clinics in Europe, North America, and the Middle East']","['PUFAs with monounsaturated fatty acids (MUFAs', 'antioxidant supplements (10 trials); dietary programmes (3 trials); and other dietary supplements (e.g. acetyl L-carnitine, biotin, creatine, palmitoylethanolamide, probiotic, riboflavin', 'supplementation to increase polyunsaturated fatty acids (PUFAs', 'dietary interventions', 'dietary intervention versus placebo', 'PUFA', 'PUFAs with MUFAs', 'omega-3 with omega-6', 'PUFAs (omega-3 versus omega-6', 'placebo']","['relapses, disability progression, and magnetic resonance imaging (MRI) measures', 'Expanded Disability Status Scale (EDSS) (mean difference (MD', 'global impression of deterioration', 'disability progression', 'serious adverse events', 'number of participants experiencing relapse and change in disability progression, according to a validated disability scale', 'health outcomes', 'relapses (risk ratio (RR', 'MRI activity, safety, and patient-reported outcomes', 'gadolinium-enhancing lesions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3839267', 'cui_str': 'Multiple sclerosis clinic'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0026068', 'cui_str': 'Middle east country'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0005575', 'cui_str': 'Biotin'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0069964', 'cui_str': 'palmidrol'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1719844', 'cui_str': 'Omega'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",86.0,0.466002,"PUFA administration may not differ when compared to alternatives with regards to relapse rate, disability worsening, or overall clinical status in people with MS, but evidence is uncertain.","[{'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'Parks', 'Affiliation': 'Department of Medicine, Division of Neurology, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Caitlin S', 'Initials': 'CS', 'LastName': 'Jackson-Tarlton', 'Affiliation': 'Department of Medicine, Division of Neurology, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vacchi', 'Affiliation': 'Department of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy.'}, {'ForeName': 'Roah', 'Initials': 'R', 'LastName': 'Merdad', 'Affiliation': 'Department of Community Health and Epidemiology, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Bradley C', 'Initials': 'BC', 'LastName': 'Johnston', 'Affiliation': 'Department of Nutrition, Texas A&M University, College Station, Texas, USA.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004192.pub4']
2716,32118601,CORR Insights®: No Difference in 5-year Clinical or Radiographic Outcomes Between Kinematic and Mechanical Alignment in TKA: A Randomized Controlled Trial.,,2020,,['TKA'],['CORR Insights®'],[],[],[],[],,0.18893,,"[{'ForeName': 'Petra J C', 'Initials': 'PJC', 'LastName': 'Heesterbeek', 'Affiliation': 'P. J. C. Heesterbeek PhD, Senior Researcher, Sint Maartenskliniek, Department of Research, Nijmegen, Netherlands.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001202']
2717,32428636,Non-Pharmacological interventions for the anxiety in patients with dementia. A cross-over randomised controlled trial.,"BACKGROUND


Behavioural and Psychiatric Symptoms in dementia (BPSD) tend to be a crucial and big problem in dementia. Anxiety several times remains under-diagnosed because it is often considered to be a psychological response to cognitive decline. As only the 10 % of patients were correctly treated, the pharmacological treatment should be well- considered. The aim of this study was to evaluate three non-pharmacological interventions for the treatment of anxiety in dementia.
METHODS


A cross-over randomised controlled trial with 60 participants (different types and stages of dementia) conducted in Greece. The sample was randomly assigned to 6 different groups of 10 participants each. The non-pharmacological interventions that have been evaluated are: a) Music Therapy b) Exercise and c) Aromatherapy & Massage. The measurements that were used are: MMSE, ACE-R, GDS, FRSSD and NPI questionnaire. The interventions lasted 5 days and there was two days off as a wash-out period. There was no drop-out rate.
RESULTS


The study showed that the most effective intervention is Music therapy. The second most effective intervention is Exercise and the third one is Aromatherapy and Massage. In the parenthesis p results indicate that Music Therapy's p is less than 0.05 in comparison with Exercise and Aromatherapy and Massage and therefore the sequence of the interventions does not interfere with the results. (p = <0.05, p = 0.55, accordingly). Caregivers' burden also reduced with MT. In the parenthesis p results indicate Music Therapy's p is less than 0.05 in comparison with the two other interventions and therefore the sequence of the interventions does not interfere with the results, as well (p = <0.05, p = 0.19).
CONCLUSIONS


Our results are in accordance with the current literature. Music Therapy is a promising alternative intervention for the treatment of anxiety in PwD. Music Therapy is an effective non-pharmacological treatment for the reduction of the caregivers' burden, because of the anxiety symptoms in PwD, such as lack of sleep, lack of personal time, unhealthy lifestyle, lack of solutions on what to do with their patients etc. The type of music, the duration of the intervention and the long-term benefits remain unclear. There is a big need of further research with stronger possible evaluation methods.",2020,In the parenthesis p results indicate that Music Therapy's p is less than 0.05 in comparison with Exercise and Aromatherapy and Massage and therefore the sequence of the interventions does not interfere with the results.,"['60 participants (different types and stages of dementia) conducted in Greece', 'dementia (BPSD', 'patients with dementia', 'anxiety in dementia']","['Music Therapy', 'Music Therapy b) Exercise and c) Aromatherapy & Massage']","['MMSE, ACE-R, GDS, FRSSD and NPI questionnaire']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",60.0,0.0553418,In the parenthesis p results indicate that Music Therapy's p is less than 0.05 in comparison with Exercise and Aromatherapy and Massage and therefore the sequence of the interventions does not interfere with the results.,"[{'ForeName': 'Tatiana-Danai', 'Initials': 'TD', 'LastName': 'Dimitriou', 'Affiliation': 'Aristotle University of Thessaloniki, 44 Salaminos Street, Halandri, 15232, Athens, Greece. Electronic address: tt.kirxof@gmail.com.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Verykouki', 'Affiliation': 'Department of Hygiene, Social Preventive Medicine and Medical Statistics, School of Medicine, Aristotle University of Thessaloniki, University Campus, 54124, Thessaloniki, Makedonia, Greece. Electronic address: e.verykouki@gmail.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Papatriantafyllou', 'Affiliation': ""3rd Age Center IASIS, 2nd Neurology Dpt., University of Athens, 'Attikon' Hospital, 73 Krimeas Str., Glyfada, Athens, Greece. Electronic address: jpapatriantafyllou@gmail.com.""}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Konsta', 'Affiliation': '1st Department of Psychiatry, ""Papageorgiou"" General Hospital of Thessaloniki, Aristotle University of Thessaloniki, Greece. Electronic address: konstaa@auth.gr.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kazis', 'Affiliation': '3rd Neurology Department, Aristotle University of Thessaloníki, Greece. Electronic address: dimitrios.kazis@gmail.com.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Tsolaki', 'Affiliation': '1st Department of Neurology, Aristotle University of Thessaloniki, Makedonia, 3 Despere Street, Thessaloniki, Greece. Electronic address: tsolakim1@gmail.com.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112617']
2718,32428586,"Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (partnerships for reducing overweight and obesity with patient-centered strategies).","BACKGROUND


Scalable, low-cost weight management strategies are needed in primary care. We conducted a pragmatic, cluster-randomized controlled trial to examine the effectiveness of an online weight management program integrated with population health management support.
METHODS


We adapted an online weight management program and integrated it with population health management support in 15 primary care practices (24 clinics). We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI). Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI) ≥ 27 and < 40 kg/m 2 , and a diagnosis of hypertension or type 2 diabetes. Participants attended routine visits and completed surveys over 18 months. The primary outcome is absolute weight change at 12 months (± 90 days) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record.
RESULTS


We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI.) At enrollment, participants' mean age was 59.3 years, their mean weight was 203.1 pounds, and their mean BMI was 32.5 kg/m 2 ; 60% of participants were female, 76% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes.
CONCLUSION


It is feasible to adapt an online weight management program and integrate it with population health management support in primary care. The results of this trial will provide valuable information about the effectiveness of these strategies in primary care settings. ClinicalTrials.govregistration number:NCT02656693.",2020,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","['Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI)\u202f≥\u202f27 and\u202f<\u202f40\u202fkg/m 2 , and a diagnosis of hypertension or type 2 diabetes', '15 primary care practices (24 clinics', ""At enrollment, participants' mean age was 59.3\u202fyears, their mean weight was 203.1 pounds, and their mean BMI was 32.5\u202fkg/m 2 ; 60% of participants were female, 76% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes"", 'We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI']","['online weight management program with population health management', 'online weight management program and integrated it with population health management support', 'usual care (UC), online program alone (OP), or combined intervention (CI', 'online weight management program integrated with population health management support']","['absolute weight change at 12\u202fmonths (± 90\u202fdays) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C4704688', 'cui_str': 'Population Health Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}]",840.0,0.0950447,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Baer', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America. Electronic address: hbaer@bwh.harvard.edu.""}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'De La Cruz', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Rozenblum', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Nyryan V', 'Initials': 'NV', 'LastName': 'Nolido', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Metzler', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Block', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Halperin', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'McManus', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Aronne', 'Affiliation': 'BMIQ Professionals Program, United States of America; Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York, NY, United States of America.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Minero', 'Affiliation': 'BMIQ Professionals Program, United States of America.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106026']
2719,32429708,Low-Intensity Cognitive Behavioral Therapy for Insomnia as the Entry of the Stepped-Care Model in the Community: A Randomized Controlled Trial.,"Background/Objectives : Diverse low-intensity interventions are available as the entry points in the stepped-care model for insomnia. The study aims to compare a single-session cognitive behavioral therapy for insomnia (CBTI) workshop, self-help CBTI and sleep hygiene education (SHE) workshop among adults with insomnia in the community, in terms of insomnia severity, anxiety and depressive symptoms, the quality of life, treatment adherence and credibility. Participants : Two-hundred-and-ten Hong Kong adults with DSM-5 defined insomnia disorder for at least one month were recruited in the community. Methods : A three-arm-parallel, active-treatment-controlled and assessor-blinded randomized controlled trial was performed. Participants were block-randomized to the half-day CBTI workshop, self-help Internet-delivered CBTI and half-day SHE workshop groups evenly. Eight-week and 16-week post-baseline follow-ups were conducted. The primary outcome measure was the Insomnia Severity Index whereas the secondary measures included the Hospital Anxiety and Depression Scale, the Short-Form Six-Dimension Health Survey, treatment adherence and credibility. Results : All arms demonstrated a significant treatment effect on insomnia severity, anxiety and depressive symptoms and the quality of life. However, there was no difference between arms. Treatment adherence did not vary among the three groups, but treatment credibility of the self-help group dropped whereas that of the CBTI workshop group rose after interventions ( p  = .037). Conclusions : Despite the lack of between-group differences, self-help CBTI can be considered as the preferred entry point of the stepped-care model for insomnia. It demonstrates comparable efficacy and adherence rate to the workshop-based interventions, and is highly accessible and convenient with few resources required.",2020,"It demonstrates comparable efficacy and adherence rate to the workshop-based interventions, and is highly accessible and convenient with few resources required.","['Participants : Two-hundred-and-ten Hong Kong adults with DSM-5 defined insomnia disorder for at least one month were recruited in the community', 'adults with insomnia in the community']","['single-session cognitive behavioral therapy for insomnia (CBTI) workshop, self-help CBTI and sleep hygiene education (SHE) workshop', 'Low-Intensity Cognitive Behavioral Therapy']","['Treatment adherence', 'insomnia severity, anxiety and depressive symptoms and the quality of life', 'Insomnia Severity Index', 'efficacy and adherence rate', 'Hospital Anxiety and Depression Scale, the Short-Form Six-Dimension Health Survey, treatment adherence and credibility']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",,0.0668142,"It demonstrates comparable efficacy and adherence rate to the workshop-based interventions, and is highly accessible and convenient with few resources required.","[{'ForeName': 'Ka-Yan', 'Initials': 'KY', 'LastName': 'Wong', 'Affiliation': 'The University of Hong Kong, Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Ka-Fai', 'Initials': 'KF', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, The University of Hong Kong, Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Chi-Hung', 'Initials': 'CH', 'LastName': 'Au', 'Affiliation': 'Department of Psychiatry, Queen Mary Hospital, Hong Kong, Hong Kong SAR.'}]",Behavioral sleep medicine,['10.1080/15402002.2020.1764000']
2720,32429137,"Crosslinked Hyaluronic Acid Gels for the Prevention of Intrauterine Adhesions after a Hysteroscopic Myomectomy in Women with Submucosal Myomas: A Prospective, Randomized, Controlled Trial.","Intrauterine adhesion (IUA), fibrosis, and scarring resulting from damage to the endometrium is a rare but serious clinical disease, contributing to a significant impairment of reproductive function. Uterine instrumentation, especially that of a hysteroscopic myomectomy, has become the main cause of IUA. Therefore, a prospective randomized controlled study to assess the effectiveness and short-term safety of the use of hyaluronic acid gels in the prevention of IUA after a hysteroscopic myomectomy and an evaluation of the characteristics of IUA observed at follow-up are presented here. A total of 70 patients were analyzed at the end of 16 March 2020. The results show that the incidence of IUA in women who underwent a hysteroscopic myomectomy is 21.4% (15/70), overall. Women treated with hyaluronic acid gels have a statistically significantly lower incidence of IUAs than non-treated women (12.8% vs. 39.1%,  p  = 0.012). In addition, women in the anti-adhesive gel treatment group had a dramatically reduced severity of IUA than women in the no-treatment group ( p  = 0.002). Further analysis shows that the International Federation of Gynecology and Obstetrics (FIGO) classification type and the use of anti-adhesive gels are independent factors associated with moderate and severe degrees of IUA formation. The results here highlight the significant therapeutic benefits of the application of hyaluronic acid gels in women undergoing a hysteroscopic myomectomy, especially for those patients with a uterine myoma classified as FIGO type 2. Since the risk of IUA after a hysteroscopic myomectomy is high, especially for patients who have not received prophylactic anti-adhesive gels, the application of hyaluronic acid gels as a prevention strategy is highly recommended. More studies are encouraged to confirm our observation.",2020,"Women treated with hyaluronic acid gels have a statistically significantly lower incidence of IUAs than non-treated women (12.8% vs. 39.1%,  p  = 0.012).","['women undergoing a', 'Women with Submucosal Myomas', 'A total of 70 patients were analyzed at the end of 16 March 2020']","['hysteroscopic myomectomy', 'Crosslinked Hyaluronic Acid Gels', 'hyaluronic acid gels', 'hyaluronic acid', 'Hysteroscopic Myomectomy']","['severity of IUA', 'incidence of IUAs', 'Intrauterine adhesion (IUA), fibrosis, and scarring', 'incidence of IUA']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0241593', 'cui_str': 'Adhesions of uterus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]",70.0,0.0977777,"Women treated with hyaluronic acid gels have a statistically significantly lower incidence of IUAs than non-treated women (12.8% vs. 39.1%,  p  = 0.012).","[{'ForeName': 'Chen-Yu', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei 112, Taiwan.'}, {'ForeName': 'Wen-Hsun', 'Initials': 'WH', 'LastName': 'Chang', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei 112, Taiwan.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cheng', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei 112, Taiwan.'}, {'ForeName': 'Hsin-Yi', 'Initials': 'HY', 'LastName': 'Huang', 'Affiliation': 'Biostatics Task Force, Taipei Veterans General Hospital, Taipei 112, Taiwan.'}, {'ForeName': 'Huann-Cheng', 'Initials': 'HC', 'LastName': 'Horng', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei 112, Taiwan.'}, {'ForeName': 'Yi-Jen', 'Initials': 'YJ', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei 112, Taiwan.'}, {'ForeName': 'Wen-Ling', 'Initials': 'WL', 'LastName': 'Lee', 'Affiliation': 'Institute of Clinical Medicine, National Yang-Ming University, Taipei 112, Taiwan.'}, {'ForeName': 'Peng-Hui', 'Initials': 'PH', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei 112, Taiwan.'}]","Life (Basel, Switzerland)",['10.3390/life10050067']
2721,32429680,Low back pain in athletes can be controlled with acupuncture by a catecholaminergic pathway: clinical trial.,"BACKGROUND


Activation of the sympathetic nervous system attenuates inflammation via catecholamines. Recent evidence has shown that electroacupuncture (EA) activates neuronal networks involved in the release of dopamine and norepinephrine that control systemic inflammation. In muscle, catecholamines are related to cyclic adenosine monophosphate (cAMP). This signaling molecule has been implicated in recovery from sustained contractile activity, which may induce muscular pain, such as that which occurs during low back pain (LBP).
OBJECTIVE


Our aim was to evaluate the effects of EA used for the control of LBP on the activation of the sympathetic nervous system in a randomized controlled clinical trial in athletes.
METHODS


Two groups of athletes with acute or chronic low back pain were studied. EA, sham EA and pharmacological treatment (diclofenac sodium) were evaluated. The outcome measures included a pain score represented by a visual analogue scale (VAS) and serum levels of catecholamines quantified by enzyme-linked immunosorbent assay. In addition, blood was collected into chilled heparin tubes, placed in 96-well cell culture plates and incubated with an equal volume of Roswell Park Memorial Institute (RPMI) medium, with lipopolysaccharide (LPS) alone or with catecholamines. Tumor necrosis factor (TNF)-α levels in the supernatants were analyzed.
RESULTS


The results indicated that the initial pain ratings did not differ between the groups analyzed. EA induced epinephrine secretion but not norepinephrine or dopamine secretion. Although EA and pharmacological treatment did not differ in terms of pain relief, in vitro epinephrine and norepinephrine reduced TNF-α production in response to LPS stimuli.
CONCLUSION


EA activates the sympathetic nervous system and induces the release of epinephrine, which could ameliorate inflammation and protect muscular tissue in addition to relieving pain.",2020,"Although EA and pharmacological treatment did not differ in terms of pain relief, in vitro epinephrine and norepinephrine reduced TNF-α production in response to LPS stimuli.
","['athletes', 'Two groups of athletes with acute or chronic low back pain were studied']","['electroacupuncture (EA', 'acupuncture', 'LBP', 'lipopolysaccharide (LPS) alone or with catecholamines', 'EA, sham EA and pharmacological treatment (diclofenac sodium', 'EA']","['pain score represented by a visual analogue scale (VAS) and serum levels of catecholamines quantified by enzyme-linked immunosorbent assay', 'Low back pain', 'pain relief', 'epinephrine secretion', 'initial pain ratings', 'Tumor necrosis factor (TNF)-α levels']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]",,0.0418227,"Although EA and pharmacological treatment did not differ in terms of pain relief, in vitro epinephrine and norepinephrine reduced TNF-α production in response to LPS stimuli.
","[{'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Arriaga-Pizano', 'Affiliation': 'Unidad de Investigación Médica en Inmunoquímica, Hospital de Especialidades del Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Ciudad de México, Mexico.'}, {'ForeName': 'Daniel Cuauhtémoc', 'Initials': 'DC', 'LastName': 'Gómez-Jiménez', 'Affiliation': 'Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional, Ciudad de México, México.'}, {'ForeName': 'Luis Angel', 'Initials': 'LA', 'LastName': 'Flores-Mejía', 'Affiliation': 'Unidad de Investigación Médica en Inmunoquímica, Hospital de Especialidades del Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Ciudad de México, Mexico.'}, {'ForeName': 'Yobana', 'Initials': 'Y', 'LastName': 'Pérez-Cervera', 'Affiliation': '""Laboratorio de Inmunología, Centro de Estudios en Ciencias de la Salud y la Enfermedad, Facultad de Odontología, Universidad Autónoma ""Benito Juárez"" de Oaxaca, Oaxaca, México.'}, {'ForeName': 'Carlos Josué', 'Initials': 'CJ', 'LastName': 'Solórzano-Mata', 'Affiliation': '""Laboratorio de Inmunología, Centro de Estudios en Ciencias de la Salud y la Enfermedad, Facultad de Odontología, Universidad Autónoma ""Benito Juárez"" de Oaxaca, Oaxaca, México.'}, {'ForeName': 'Constantino', 'Initials': 'C', 'LastName': 'López-Macías', 'Affiliation': 'Unidad de Investigación Médica en Inmunoquímica, Hospital de Especialidades del Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Ciudad de México, Mexico.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Isibasi', 'Affiliation': 'Unidad de Investigación Médica en Inmunoquímica, Hospital de Especialidades del Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social (IMSS), Ciudad de México, Mexico.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Torres-Rosas', 'Affiliation': '""Laboratorio de Inmunología, Centro de Estudios en Ciencias de la Salud y la Enfermedad, Facultad de Odontología, Universidad Autónoma ""Benito Juárez"" de Oaxaca, Oaxaca, México.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420912251']
2722,32429839,Sevoflurane versus PRopofol combined with Remifentanil anesthesia Impact on postoperative Neurologic function in supratentorial Gliomas (SPRING): protocol for a randomized controlled trial.,"BACKGROUND


Patients with intracranial tumors are more sensitive to anesthetics than the general population and are therefore more susceptible to postoperative neurologic and neurocognitive dysfunction. Sevoflurane or propofol combined with remifentanil are widely used general anesthetic regimens for craniotomy, with neither regimen shown to be superior to the other in terms of neuroprotective efficacy and anesthesia quality. There is no evidence regarding the variable effects on postoperative neurologic and neurocognitive functional outcome under these two general anesthetic regimens. This trial will compare inhalational sevoflurane or intravenous propofol combined with remifentanil anesthesia in patients with supratentorial gliomas and test the hypothesis that postoperative neurologic function is equally affected between the two regimens.
METHODS


This is a prospective, single-center, randomized parallel arm equivalent clinical trial, which is approved by China Ethics Committee of Registering Clinical Trials (ChiECRCT-20,160,051). Patients with supratentorial gliomas diagnosed by magnetic resonance imaging will be eligible for the trial. Written informed consent will be obtained before randomly assigning each subject to either the sevoflurane-remifentanil or propofol-remifentanil group for anesthesia maintenance to achieve an equal-desired depth of anesthesia. Intraoperative intervention and monitoring will follow a standard anesthetic management protocol. All of the physiological parameters and other medications administered during the intervention will be recorded. The primary outcome will be neurologic function change assessed by National Institute of Health Stroke Scale (NIHSS) within 4 h after general anesthesia when observer's assessment of alertness/sedation (OAA/S) reaches 4. Secondary outcomes will include NIHSS and modified NIHSS change 1 and 2 days after general anesthesia, hemodynamic stability, intraoperative brain relaxation, quality of anesthesia emergence, quality of anesthesia recovery, postoperative cognitive function, postoperative pain, postoperative neurologic complications, as well as perioperative medical expense.
DISCUSSION


This randomized equivalency trial will primarily compare the impacts of sevoflurane-remifentanil and propofol-remifentanil anesthesia on short-term postoperative neurologic function in patients with supratentorial gliomas undergoing craniotomy. The exclusion criteria are strict to ensure that the groups are comparable in all aspects. Repeated and routine neurologic evaluations after operation are always important to evaluate neurosurgical patients' recovery and any newly presenting complications. The results of this trial would help specifically to interpret anesthetic residual effects on postoperative outcomes, and perhaps would help the anesthesiologist to select the optimal anesthetic regimen to minimize its impact on neurologic function in this specific patient population.
TRIAL REGISTRATION


The study was registered and approved by the Chinese Clinical Trial Registry (Chinese Clinical Trial Registry, ChiCTR-IOR-16009177). Principle investigator: Nan Lin (email address: linnan127@gmail.com) and Ruquan Han (email address: hanrq666@aliyun.com) Date of Registration: September 8th, 2016. Country of recruitment: China.",2020,The primary outcome will be neurologic function change assessed by National Institute of Health Stroke Scale (NIHSS) within 4 h after general anesthesia when observer's assessment of alertness/sedation (OAA/S) reaches 4.,"['patients with supratentorial gliomas', 'patients with supratentorial gliomas undergoing craniotomy', 'supratentorial Gliomas (SPRING', 'Patients with supratentorial gliomas diagnosed by', 'Patients with intracranial tumors']","['Intraoperative intervention', 'propofol combined with remifentanil anesthesia', 'hanrq666@aliyun.com', 'Sevoflurane', 'inhalational sevoflurane', 'Remifentanil anesthesia', 'sevoflurane-remifentanil or propofol-remifentanil', 'magnetic resonance imaging', 'sevoflurane-remifentanil and propofol-remifentanil anesthesia', 'Lin (email address: linnan127@gmail.com) and Ruquan Han (email address', 'PRopofol', 'Sevoflurane or propofol combined with remifentanil']","['postoperative Neurologic function', ""neurologic function change assessed by National Institute of Health Stroke Scale (NIHSS) within 4\u2009h after general anesthesia when observer's assessment of alertness/sedation (OAA/S) reaches 4"", 'postoperative neurologic function', 'postoperative neurologic and neurocognitive functional outcome', 'NIHSS and modified NIHSS change 1 and 2 days after general anesthesia, hemodynamic stability, intraoperative brain relaxation, quality of anesthesia emergence, quality of anesthesia recovery, postoperative cognitive function, postoperative pain, postoperative neurologic complications, as well as perioperative medical expense']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1527390', 'cui_str': 'Intracranial tumor'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0574448', 'cui_str': 'Lingala language'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0641339', 'cui_str': 'hexaaquanickel(II) chlorate'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]",,0.123406,The primary outcome will be neurologic function change assessed by National Institute of Health Stroke Scale (NIHSS) within 4 h after general anesthesia when observer's assessment of alertness/sedation (OAA/S) reaches 4.,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China. linnan127@gmail.com.'}, {'ForeName': 'Ruquan', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China. Hanrq666@aliyun.com.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Bebawy', 'Affiliation': 'Departments of Anesthesiology & Neurological Surgery, Northwestern University Feinberg School of Medicine, 251 E. Huron St., F5-704, Chicago, IL, 60611, USA.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Xiaoyuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Manyu', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}, {'ForeName': 'Lanyi', 'Initials': 'L', 'LastName': 'Nie', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No.119, West Road 4th ring South, Fengtai District, Beijing, 100070, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01035-5']
2723,32434300,The Effect of Continuous Care Model Implementation on the Quality of Life of Patients with Heart Failure: A Randomized Controlled Trial.,"Background


Heart failure is an important chronic and progressive disease worldwide. Patients are faced with several stressors that decrease their quality of life (QoL). The present study aimed to determine the effectiveness of implementing a continuous care model on improving the QoL of patients with heart failure.
Methods


In the present randomized controlled trial, 72 patients with heart failure admitted to Shahid Chamran Hospital of Isfahan (in Central Iran) were randomly divided into 36-individual two groups: the experimental (continuous care model) and control (normal care) groups. In the experimental group, the continuous care model was implemented for 3 months. Data were collected using the standard Minnesota Living with Heart Failure Questionnaire for patients with heart failure. Subsequently, the collected data were entered into the IBM SPSS ver. 20.0 (IBM Corp., Armonk, NY, USA) and analyzed using the Mann-Whitney U-test, chi-square test, and independent and paired t-test at a significance level of α≤0.05.
Results


The results indicated that the mean scores of QoL before the implementation of continuous care model were 43.3±6.1 in the experimental group and 42.7±5.1 in the control group, indicating no statistically significant difference between the two groups. After the implementation of continuous care model, the mean score of QoL of the experimental group was significantly higher than that of the control group.
Conclusion


Considering the results obtained in the present study, model implementation could improve the overall scores of QoL in patients with chronic heart failure.",2020,"After the implementation of continuous care model, the mean score of QoL of the experimental group was significantly higher than that of the control group.
","['Patients with Heart Failure', 'patients with chronic heart failure', 'patients with heart failure', '72 patients with heart failure admitted to Shahid Chamran Hospital of Isfahan (in Central Iran']",['Continuous Care Model Implementation'],"['quality of life (QoL', 'Quality of Life', 'mean score of QoL', 'overall scores of QoL', 'mean scores of QoL before the implementation of continuous care model']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",72.0,0.0222881,"After the implementation of continuous care model, the mean score of QoL of the experimental group was significantly higher than that of the control group.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rezamand', 'Affiliation': 'Student Research Committee, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Shahnazi', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Hassanzadeh', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Korean journal of family medicine,['10.4082/kjfm.20.0040']
2724,32429553,Effects of Cognitive Behavioral Group Program for Mental Health Promotion of University Students.,"This study aimed to explore the effects of a group cognitive behavioral program on depression, self-esteem, and interpersonal relations among undergraduate students. A non-equivalent control group pretest-posttest design was used. A convenient sample of 37 undergraduates (18 in the experimental group and 19 in the control group) at K university located in Changwon, South Korea was used. Data were collected from February 4, 2019 to June 18, 2019. The experimental group received eight sessions of the program, which were scheduled twice a week, with each session lasting 90 min. Collected data were analyzed using a chi-square test, Fisher's exact test, independent  t -test, and repeated measures ANOVA by SPSS/WIN 23.0 (SPSS, Inc., Chicago, IL, USA). The interaction of group and time was significant, indicating that the experimental group showed an improvement in depression, self-esteem, and personal relationship compared to the control group. A significant group by time interaction for depression, self-esteem, and personal relationship was also found between the two groups. The study results revealed that the group cognitive behavioral program was effective in reducing depression and improving self-esteem and interpersonal relation. Therefore, the group cognitive behavioral program can be used for promoting the mental health of students as well as for preventing depression in a university setting.",2020,"A significant group by time interaction for depression, self-esteem, and personal relationship was also found between the two groups.","['37 undergraduates (18 in the experimental group and 19 in the control group) at K university located in Changwon, South Korea was used', 'undergraduate students', 'Mental Health Promotion of University Students', 'Data were collected from February 4, 2019 to June 18, 2019']","['Cognitive Behavioral Group Program', 'group cognitive behavioral program']","['depression and improving self-esteem and interpersonal relation', 'time interaction for depression, self-esteem, and personal relationship', 'depression, self-esteem, and interpersonal relations', 'depression, self-esteem, and personal relationship']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0129976,"A significant group by time interaction for depression, self-esteem, and personal relationship was also found between the two groups.","[{'ForeName': 'Soojung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Kyungnam University, 7, Gyeongnamdaehak-ro, Masanhappo-gu, Changwon-si, Gyeongnam 51767, Korea.'}, {'ForeName': 'Eunjoo', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Kyungnam University, 7, Gyeongnamdaehak-ro, Masanhappo-gu, Changwon-si, Gyeongnam 51767, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17103500']
2725,32429733,Evervac: phase I/II study of immunogenicity and safety of a new adjuvant-free TBE vaccine cultivated in Vero cell culture.,"Approximately 10,000 cases of tick-borne encephalitis (TBE), a serious disease of the central nervous system caused by tick-borne encephalitis virus (TBEV), are registered worldwide every year. Vaccination against TBE remains the most essential measure of preventing the disease. Unlike available TBE vaccines, a new inactivated lyophilized candidate vaccine Evervac is produced in Vero continuous cell culture and its final formulation does not include aluminum-based adjuvants. To study the safety and immunogenicity of Evervac, healthy adults 18-60 y of age were immunized twice at 30-d intervals. The study was single-blind, randomized, comparative, controlled, and was conducted in TBE-endemic areas. The commercial lyophilized vaccine TBE-Moscow was used as a comparison treatment. The subjects were observed for incidence, severity, and duration of adverse reactions. It was shown that the severity of local and systemic reactions in the Evervac vaccine group was mild to moderate. There were no significant differences in the incidence of adverse reactions between the Evervac and TBE-Moscow vaccine groups. Immunization with Evervac produced a significant increase in geometric mean titer (GMT) of anti-TBEV antibodies in both initially seronegative and seropositive recipients. The seroconversion rate for the initially seronegative recipients was 69% (GMT = 1:214) after the first dose and reached 100% after the second dose. In these parameters, there were no significant differences between the study and control vaccine groups. Thus, the adjuvant-free Vero-based vaccine Evervac was well tolerated, had low reactogenicity, induced a pronounced immune response, and was overall non-inferior to the commercial adjuvanted TBE vaccine used as a control.",2020,Immunization with Evervac produced a significant increase in geometric mean titer (GMT) of anti-TBEV antibodies in both initially seronegative and seropositive recipients.,"['healthy adults 18-60\xa0y of age were immunized twice at 30-d intervals', 'Vero cell culture']",['new adjuvant-free TBE vaccine cultivated'],"['incidence, severity, and duration of adverse reactions', 'seroconversion rate', 'severity of local and systemic reactions', 'incidence of adverse reactions', 'geometric mean titer (GMT) of anti-TBEV antibodies']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0042542', 'cui_str': 'Vero Cells'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0593408', 'cui_str': 'Tick-borne encephalitis vaccine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0040203', 'cui_str': 'Ixodida'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0014051', 'cui_str': 'Encephalitis Virus'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.0161945,Immunization with Evervac produced a significant increase in geometric mean titer (GMT) of anti-TBEV antibodies in both initially seronegative and seropositive recipients.,"[{'ForeName': 'Mikhail F', 'Initials': 'MF', 'LastName': 'Vorovitch', 'Affiliation': 'TBE Vaccine Department, Federal State Budgetary Scientific Institution ""Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences"" (FSBSI ""Chumakov FSC R&D IBP RAS""), Moscow, Russia.'}, {'ForeName': 'Karina G', 'Initials': 'KG', 'LastName': 'Grishina', 'Affiliation': 'TBE Vaccine Department, Federal State Budgetary Scientific Institution ""Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences"" (FSBSI ""Chumakov FSC R&D IBP RAS""), Moscow, Russia.'}, {'ForeName': 'Viktor P', 'Initials': 'VP', 'LastName': 'Volok', 'Affiliation': 'Laboratory of Biology of Arboviruses, Federal State Budgetary Scientific Institution ""Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences"" (FSBSI ""Chumakov FSC R&D IBP RAS""), Moscow, Russia.'}, {'ForeName': 'Liubov L', 'Initials': 'LL', 'LastName': 'Chernokhaeva', 'Affiliation': 'TBE Vaccine Department, Federal State Budgetary Scientific Institution ""Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences"" (FSBSI ""Chumakov FSC R&D IBP RAS""), Moscow, Russia.'}, {'ForeName': 'Konstantin V', 'Initials': 'KV', 'LastName': 'Grishin', 'Affiliation': 'TBE Vaccine Department, Federal State Budgetary Scientific Institution ""Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences"" (FSBSI ""Chumakov FSC R&D IBP RAS""), Moscow, Russia.'}, {'ForeName': 'Galina G', 'Initials': 'GG', 'LastName': 'Karganova', 'Affiliation': 'Laboratory of Biology of Arboviruses, Federal State Budgetary Scientific Institution ""Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences"" (FSBSI ""Chumakov FSC R&D IBP RAS""), Moscow, Russia.'}, {'ForeName': 'Aidar A', 'Initials': 'AA', 'LastName': 'Ishmukhametov', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences"" (FSBSI ""Chumakov FSC R&D IBP RAS""), Moscow, Russia.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1757990']
2726,31160034,Association of Staphylococcus aureus colonization with food allergy occurs independently of eczema severity.,"BACKGROUND


Staphylococcus aureus has been implicated in the pathophysiology of eczema, allergic rhinitis, asthma, and food allergy. S aureus is a marker of more severe eczema, which is a risk factor for food sensitization/allergy. Therefore it might be that the association between S aureus and food allergy in eczematous patients is related to eczema severity.
OBJECTIVE


We sought to investigate the association of S aureus colonization with specific IgE (sIgE) production to common food allergens and allergies in early childhood independent of eczema severity. We additionally determined the association of S aureus colonization with eczema severity and persistence.
METHODS


In Learning Early About Peanut Allergy (LEAP) study participants eczema severity was assessed, and skin/nasal swabs were cultured for S aureus. Sensitization was identified by measuring sIgE levels. Peanut allergy was primarily determined by means of oral food challenge, and persistent egg allergy was primarily determined by using skin prick tests.
RESULTS


Skin S aureus colonization was significantly associated with eczema severity across the LEAP study, whereas at 12 and 60 months of age, it was related to subsequent eczema deterioration. Skin S aureus colonization at any time point was associated with increased levels of hen's egg white and peanut sIgE independent of eczema severity. Participants with S aureus were more likely to have persistent egg allergy and peanut allergy at 60 and 72 months of age independent of eczema severity. All but one of the 9 LEAP study consumers with peanut allergy (9/312) were colonized at least once with S aureus.
CONCLUSION


S aureus, independent of eczema severity, is associated with food sensitization and allergy and can impair tolerance to foods. This could be an important consideration in future interventions aimed at inducing and maintaining tolerance to food allergens in eczematous infants.",2019,Participants with S aureus were more likely to have persistent egg allergy and peanut allergy at 60 and 72 months of age independent of eczema severity.,"['eczematous infants', 'Participants with S aureus were more likely to have persistent egg allergy and peanut allergy at 60 and 72\xa0months of age independent of eczema severity', 'eczematous patients']",[],"[""levels of hen's egg white and peanut sIgE""]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0559469', 'cui_str': 'Allergy to edible egg'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1270751', 'cui_str': 'Peanut specific immunoglobulin E'}]",,0.0531977,Participants with S aureus were more likely to have persistent egg allergy and peanut allergy at 60 and 72 months of age independent of eczema severity.,"[{'ForeName': 'Olympia', 'Initials': 'O', 'LastName': 'Tsilochristou', 'Affiliation': ""Peter Gorer Department of Immunobiology, School of Immunology & Microbial Sciences, London, United Kingdom; Pediatric Allergy Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'du Toit', 'Affiliation': ""Peter Gorer Department of Immunobiology, School of Immunology & Microbial Sciences, London, United Kingdom; Pediatric Allergy Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom; Children's Allergy Service, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Sayre', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, University of California, San Francisco, Calif.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'University of Southampton and Southampton NIHR Biomedical Research Centre, Southampton, United Kingdom; David Hide Centre, Isle of Wight, United Kingdom.'}, {'ForeName': 'Kaitie', 'Initials': 'K', 'LastName': 'Lawson', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, NC.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Sever', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, NC.'}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Bahnson', 'Affiliation': 'Immune Tolerance Network, San Francisco, Calif.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Radulovic', 'Affiliation': ""Peter Gorer Department of Immunobiology, School of Immunology & Microbial Sciences, London, United Kingdom; Pediatric Allergy Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom; Children's Allergy Service, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Basting', 'Affiliation': ""Peter Gorer Department of Immunobiology, School of Immunology & Microbial Sciences, London, United Kingdom; Pediatric Allergy Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom; Children's Allergy Service, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Plaut', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Md.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Lack', 'Affiliation': ""Peter Gorer Department of Immunobiology, School of Immunology & Microbial Sciences, London, United Kingdom; Pediatric Allergy Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom; Children's Allergy Service, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom. Electronic address: gideon.lack@kcl.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.04.025']
2727,32434359,Effectiveness of different silicone oil remove methods after vitrectomy and light silicone oil tamponade in elderly patients.,"BACKGROUND


During the remove of oil from the silicone oil-filled eye after vitrectomy, perfusion fluid is often mistakenly aspirated when mechanical force is used to remove the oil. This leads to a sudden sharp drop in intraocular pressure and collapse of the eyeball, which may cause complications. The aspiration of perfusion fluid can be detected when the oil is removed manually, and the force of the hand and location of the aspiration can be adjusted to remove the silicone oil instead. In this study, we assessed the efficacy and safety of a manual 23-gauge (23G) silicone oil remove method and confirmed that this is a feasible, highly efficient, safe, simple and economical way to remove oil.
METHODS


We recruited 130 patients (130 affected eyes) 3-6 months after they had undergone vitrectomy and light silicone oil tamponade at our hospital. The patients/eyes were randomly divided into two groups (manual or vitrectomy system), with 65 eyes in each group. All eyes in both groups underwent 23G oil remove by the same physician. The following aspects of the two groups were compared: 1. Oil remove duration; 2. Average intraocular pressure at 1 day, 1 week and 1 month after the procedure; and 3. Postoperative complications, such as retinal redetachment, silicone oil residue, massive suprachoroidal hemorrhage and choroid detachment.
RESULTS


The average oil remove durations of the manual group and the vitrectomy system group were 5.92±1.34 and 8.87±1.68 min, respectively (P<0.05); the duration for the manual group was significantly shorter than that for the vitrectomy system group (t=11.07, P=0). The average intraocular pressures at 1 day, 1 week and 1 month after operation of the manual group were 10.2±2.7, 15.2±3.5 and 17.2±3.1 mmHg, respectively, and those of the vitrectomy system group were 9.8±2.4, 15.5±3.1 and 16.8±3.4 mmHg, respectively; the differences between the two groups were not statistically significant at any time point (t=0.892, P=0.374 at 1 day; t=0.517, P=0.606 at 1 week; and t=0.701, P=0.485 at 1 month). The difference in the incidence of postoperative complications, including retinal redetachment, silicone oil residue, massive suprachoroidal hemorrhage and choroid detachment, between the two groups was statistically significant (χ 2 =4.2787, P=0.0386). None of the affected eyes were complicated with transient intraocular hypotension, vitreous hemorrhage or endophthalmitis.
CONCLUSIONS


The manual 23G silicone oil remove method is highly efficient, safe, simple and economical and can be used conveniently and clinically by the majority of medical institutions.",2020,"The manual 23G silicone oil remove method is highly efficient, safe, simple and economical and can be used conveniently and clinically by the majority of medical institutions.","['130 patients (130 affected eyes) 3-6 months after they had undergone vitrectomy and light silicone oil tamponade at our hospital', 'elderly patients']","['silicone oil remove methods after vitrectomy and light silicone oil tamponade', 'manual 23-gauge (23G) silicone oil']","['Average intraocular pressure', 'average intraocular pressures', 'Postoperative complications, such as retinal redetachment, silicone oil residue, massive suprachoroidal hemorrhage and choroid detachment', 'efficacy and safety', 'transient intraocular hypotension, vitreous hemorrhage or endophthalmitis', 'incidence of postoperative complications, including retinal redetachment, silicone oil residue, massive suprachoroidal hemorrhage and choroid detachment', 'average oil remove durations']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C1644185', 'cui_str': 'Suprachoroidal hemorrhage'}, {'cui': 'C0008520', 'cui_str': 'Choroidal structure'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0042909', 'cui_str': 'Vitreous hemorrhage'}, {'cui': 'C0014236', 'cui_str': 'Endophthalmitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",130.0,0.0259711,"The manual 23G silicone oil remove method is highly efficient, safe, simple and economical and can be used conveniently and clinically by the majority of medical institutions.","[{'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': ""Department of Ophthalmology, Liuzhou People's Hospital, Liuzhou 545006, China. wanxiaobo_gx@163.com.""}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Liuzhou Hospital of Traditional Chinese Medicine, Liuzhou 545006, China.'}, {'ForeName': 'Qiguang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, Liuzhou Hospital of Traditional Chinese Medicine, Liuzhou 545006, China.'}]",Annals of palliative medicine,['10.21037/apm-20-949']
2728,32434381,Randomised Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent with the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated with Percutaneous Coronary Intervention: The SORT OUT IX Trial.,"Background:  In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared to a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is non-inferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention.  Methods:  The Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX trial, was a large-scale, registry-based, randomized, multicenter, single-blind, two-arm, non-inferiority trial. The primary endpoint, major adverse cardiovascular events (MACE), was defined as the composite of cardiac death, myocardial infarction not related to any segment other than the target lesion or target lesion revascularization within 1 year, analyzed by intention-to-treat. The trial was powered to assess non-inferiority for MACE of the BioFreedom stent compared with the Orsiro stent with a predetermined non-inferiority margin of 0.021. The trial is registered with ClinicalTrials.gov, NCT02623140.  Results:  Between December 14, 2015 and April 21, 2017, 3,151 patients were assigned to treatment with the BioFreedom stent (1,572 patients, 1,966 lesions) or to the Orsiro stent (1,579 patients, 1,985 lesions). Five patients were lost to follow-up because of emigration (99.9% follow-up rate). Mean age was 66.3 {plus minus} 10.9, diabetes was seen in 19.3% of patients and 53% of the patients had acute coronary syndromes. At 1 year, intention-to-treat analysis showed that 79 (5.0%) patients, who were assigned the BioFreedom stent, and 59 (3.7%), who were assigned the Orsiro stent, met the primary endpoint (absolute risk difference 1.29% [upper limit of one-sided 95% CI 2.50%]; p(non-inferiority)=0.14). Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77 [95% CI 1.66-4.62]; p<0.0001).  Conclusions: The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for non-inferiority for MACE at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population  Clinical Trial Registration:  URL: https://clinicaltrials.gov Unique Identifier: NCT02623140.",2020,"Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77","['Results:  Between December 14, 2015 and April 21, 2017', 'comers patient population treated with percutaneous coronary intervention', '1,572 patients, 1,966 lesions) or to the Orsiro stent (1,579 patients, 1,985 lesions', '3,151 patients']","['Polymer-Free Biolimus-Coated BioFreedom Stent with the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent', 'modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent', 'Percutaneous Coronary Intervention', 'BioFreedom stent']","['composite of cardiac death, myocardial infarction not related to any segment other than the target lesion or target lesion revascularization within 1 year, analyzed by intention-to-treat', 'target lesion revascularization', 'acute coronary syndromes', 'major adverse cardiovascular events (MACE']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}]",3151.0,0.23069,"Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77","[{'ForeName': 'Lisette Okkels', 'Initials': 'LO', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Raungaard', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Kahlert', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ellert', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anton Boel', 'Initials': 'AB', 'LastName': 'Villadsen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Karsten Tange', 'Initials': 'KT', 'LastName': 'Veien', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Steen Dalby', 'Initials': 'SD', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Ahlehoff', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Carstensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.'}, {'ForeName': 'Martin Kirk', 'Initials': 'MK', 'LastName': 'Christensen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Christian Juhl', 'Initials': 'CJ', 'LastName': 'Terkelsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstroem', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Knud Nørregaard', 'Initials': 'KN', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Aaroe', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Troels', 'Initials': 'T', 'LastName': 'Thim', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Thuesen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Freeman', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Aziz', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Eftekhari', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Junker', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Svend Eggert', 'Initials': 'SE', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jens Flensted', 'Initials': 'JF', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark; Department of Cardiology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Steen Hansen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Evald Høj', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.'}]",Circulation,['10.1161/CIRCULATIONAHA.119.040241']
2729,32434492,Loneliness as a predictor of outcomes in mental disorders among people who have experienced a mental health crisis: a 4-month prospective study.,"BACKGROUND


Loneliness has not until recently been a prominent focus in research on outcomes of mental illness. The aim of this study was to determine whether loneliness at baseline predicts poor outcomes at 4-month follow-up for individuals who have experienced mental health crises. The outcomes in this study included overall symptom severity, affective symptoms, self-rated recovery and health-related quality of life.
METHODS


Our study reports a secondary analysis of data from a randomised controlled trial. The sample (n = 399) was taken from patients who received treatment from community crisis services. Respondents (n = 310) completed the follow-up measurement 4 months after baseline. Loneliness at baseline was assessed using an eight-item UCLA Loneliness Scale. The four mental health outcomes were measured at both baseline and follow-up. Two scales (or part thereof) assessed objective social isolation and neighbourhood social capital at baseline. Regression analyses were conducted to investigate longitudinal associations between loneliness at baseline and mental health outcomes at follow-up.
RESULTS


Loneliness at baseline was associated with all four mental health outcomes at 4-month follow-up, adjusting for psychosocial, socio-demographic and clinical characteristics. A one-point higher loneliness score was associated with 0.74-point (95% CI 0.45, 1.02) and 0.34-point (95% CI 0.21, 0.47) increase in overall symptom severity score and affective symptoms score respectively, and with 1.08-point (95% CI -1.45, - 0.71) and 1.27-point (95% CI -1.79, - 0.75) decrease in self-rated recovery score and health-related quality of life score respectively. Loneliness was a better predictor of clinical outcomes than objective social isolation and social capital, even though the associations with clinical outcomes were reduced and no longer statistically significant following adjustment for their baseline values. A significant association with quality of life persisted after adjustment for its baseline score.
CONCLUSIONS


Greater loneliness at baseline predicted poorer health-related quality of life at follow-up. There were cross-sectional associations between loneliness and clinical outcomes, but their longitudinal relationship cannot be confirmed. Further research is needed to clearly establish their underpinning pathways. Reducing loneliness may be a promising target to improve recovery for mental health community crisis service users.",2020,"A one-point higher loneliness score was associated with 0.74-point (95% CI 0.45, 1.02) and 0.34-point (95% CI 0.21, 0.47) increase in overall symptom severity score and affective symptoms score respectively, and with 1.08-point (95% CI -1.45, - 0.71) and 1.27-point (95% CI -1.79, - 0.75) decrease in self-rated recovery score and health-related quality of life score respectively.","['people who have experienced a mental health crisis', 'individuals who have experienced mental health crises', 'mental health community crisis service users']",[],"['quality of life', 'self-rated recovery score and health-related quality of life score', 'overall symptom severity, affective symptoms, self-rated recovery and health-related quality of life', 'health-related quality of life', 'overall symptom severity score and affective symptoms score', 'loneliness score', 'objective social isolation and neighbourhood social capital']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C1510639', 'cui_str': 'Social Capital'}]",,0.216986,"A one-point higher loneliness score was associated with 0.74-point (95% CI 0.45, 1.02) and 0.34-point (95% CI 0.21, 0.47) increase in overall symptom severity score and affective symptoms score respectively, and with 1.08-point (95% CI -1.45, - 0.71) and 1.27-point (95% CI -1.79, - 0.75) decrease in self-rated recovery score and health-related quality of life score respectively.","[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. jingyi.wang.13@ucl.ac.uk.'}, {'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, UCL Medical School, Rowland Hill Street, London, NW3 2PF, UK.'}, {'ForeName': 'Farhana', 'Initials': 'F', 'LastName': 'Mann', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Ruimin', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. s.johnson@ucl.ac.uk.'}]",BMC psychiatry,['10.1186/s12888-020-02665-2']
2730,32434619,Ageism: can a museum exhibit make a difference?,"Ageism is a key challenge to today's aging societies. ""Dialogue with Time"" is an original Israeli interactive museum exhibit that aims to change negative ageist attitudes by creating a meaningful and stereotype-breaking encounter between visitors and old age. The objective of this study was to examine whether the exhibition reduces ageist attitudes among its visitors. The study employed a comparative pre-post structure with a comparison group. A closed-answer questionnaire was supplied to 100 participants in the experimental group, visitors to the ""Dialogue with Time"" exhibit, and to 100 participants in the control group. Participants were asked to complete the questionnaire before entering the exhibits and again after experiencing them. Changes in the level of ageism were measured using the Farboni Scale of Ageism. A significant reduction in ageism attitudes was shown in the experimental group when comparing before and after the visit, t(91) = 11.75, p = 0.001, with a good effect size of Cohen's d = 0.50, whereas in the control group there was no significant change, t(76) = 0.05, p = 0.95, and a weak effect size of Cohen's d = 0.00. The findings indicate that combating ageism can also be sustained by means of museum exhibits. We recommend that museums and other similar public institutions (e.g. art galleries, exhibition halls) use public spaces to advance multigenerational exposure to positive images of aging.",2020,"A significant reduction in ageism attitudes was shown in the experimental group when comparing before and after the visit, t(91) =","['100 participants in the experimental group, visitors to the ""Dialogue with Time"" exhibit, and to 100 participants in the control group']",[],['ageism attitudes'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332311', 'cui_str': 'With time'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0242449', 'cui_str': 'Age Discrimination'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",100.0,0.0251055,"A significant reduction in ageism attitudes was shown in the experimental group when comparing before and after the visit, t(91) =","[{'ForeName': 'Moran', 'Initials': 'M', 'LastName': 'Fruhauf', 'Affiliation': 'Department of Gerontology, University of Haifa, Haifa, Israel, 31905.'}, {'ForeName': 'Israel Issi', 'Initials': 'II', 'LastName': 'Doron', 'Affiliation': 'Center for Research and Study of Ageing (CRSA), University of Haifa, Haifa, Israel, 31905.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Palgi', 'Affiliation': 'Department of Gerontology, University of Haifa, Haifa, Israel, 31905.'}]",International psychogeriatrics,['10.1017/S1041610220000617']
2731,32434637,[Application of vacuum stretcher combined with feeding in cranial magnetic resonance imaging examination for neonates: a prospective randomized controlled study].,"OBJECTIVE


To study the effect and safety of vacuum stretcher combined with feeding in cranial magnetic resonance imaging (MRI) examination for neonates.
METHODS


A prospective study was performed for the neonates with hyperbilirubinemia, with a gestational age of >34 weeks and stable vital signs, who needed cranial MRI examination and did not need oxygen inhalation hospitalized in the Department of Neonatology, Children's Hospital of Zhejiang University School of Medicine, from September to November, 2019. The neonates were randomly divided into a vacuum stretcher combined with feeding group and a conventional sedation group. Vital signs were monitored before, during, and after MRI examination. The success rate of MRI procedure was recorded.
RESULTS


A total of 80 neonates were enrolled in the study, with 40 neonates in the vacuum stretcher combined with feeding group and 40 in the conventional sedation group. The vacuum stretcher combined with feeding group had a significantly higher success rate of MRI procedure than the conventional sedation group (P<0.05). As for the neonates who underwent successful MRI examination, the fastest heart rate after examination in the vacuum stretcher combined with feeding group was significantly lower than that in the conventional sedation group (P<0.05), while there were no significant differences between the two groups in transcutaneous oxygen saturation, respiratory rate, and body temperature before and after MRI examination (P>0.05). No complications, such as apnea, acute allergic reactions, and malignant fever, were observed.
CONCLUSIONS


Vacuum stretcher combined with feeding can improve the success rate of MRI procedure and reduce the use of sedatives, and meanwhile, it does not increase related risks.",2020,The vacuum stretcher combined with feeding group had a significantly higher success rate of MRI procedure than the conventional sedation group (P<0.05).,"['neonates', '80 neonates were enrolled in the study, with 40 neonates in the vacuum stretcher combined with feeding group and 40 in the conventional sedation group', ""neonates with hyperbilirubinemia, with a gestational age of >34 weeks and stable vital signs, who needed cranial MRI examination and did not need oxygen inhalation hospitalized in the Department of Neonatology, Children's Hospital of Zhejiang University School of Medicine, from September to November, 2019""]","['vacuum stretcher combined with feeding group and a conventional sedation group', 'cranial magnetic resonance imaging examination', 'vacuum stretcher combined with feeding in cranial magnetic resonance imaging (MRI) examination', 'vacuum stretcher combined with feeding']","['fastest heart rate', 'transcutaneous oxygen saturation, respiratory rate, and body temperature', 'No complications, such as apnea, acute allergic reactions, and malignant fever', 'success rate of MRI procedure']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0150789', 'cui_str': 'Stretcher'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0027621', 'cui_str': 'Neonatology'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0150789', 'cui_str': 'Stretcher'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0413234', 'cui_str': 'Acute allergic reaction'}, {'cui': 'C0024591', 'cui_str': 'Malignant hyperthermia'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",80.0,0.058861,The vacuum stretcher combined with feeding group had a significantly higher success rate of MRI procedure than the conventional sedation group (P<0.05).,"[{'ForeName': 'Xiao-Xia', 'Initials': 'XX', 'LastName': 'Shen', 'Affiliation': ""Department of Neonatal Intensive Care Unit, Children's Hospital, Zhejiang University School of Medicine, Hangzhou 310051, China. maxiaolu_zjuch@zju.edu.cn.""}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Fu-Sheng', 'Initials': 'FS', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Li-Zhong', 'Initials': 'LZ', 'LastName': 'DU', 'Affiliation': ''}, {'ForeName': 'Xiao-Lu', 'Initials': 'XL', 'LastName': 'Ma', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
2732,32434884,HIV RNA Rebound in Seminal Plasma after Antiretroviral Treatment Interruption.,"Background:  If strategies currently in development succeed in eradicating HIV reservoirs in peripheral blood and lymphoid tissues, residual sources of virus may remain in anatomic compartments. Methods:  Paired blood and semen samples were collected from 12 individuals enrolled in a randomized, double-blind, placebo-controlled therapeutic vaccine clinical trial in people with HIV (PWH) who began ART during acute or early infection (NCT01859325). After the week 56 visit (post intervention), all participants interrupted antiretroviral therapy (ART). At the first available time-points after viral rebound, we sequenced HIV-1  env  ( C2-V3 ),  gag (p24),  and  pol ( reverse transcriptase) regions amplified from cell-free HIV RNA in blood and seminal plasma using the MiSeq Illumina platform. Comprehensive sequence and phylogenetic analyses were performed to evaluate viral population structure, compartmentalization and viral diversity in blood and seminal plasma. Results:  Compared to blood, HIV RNA rebound in semen occurred significantly later (median of 66 versus 42 days post ART interruption, P<0.01) and reached lower levels (median 164 versus 16,090 copies/ml, P<0.01). Three out of 5 participants with available sequencing data, presented compartmentalized viral rebound between blood and semen in one HIV coding region. Despite early ART initiation, HIV RNA molecular diversity was higher in semen compared to blood in all three coding regions for most participants. Conclusions:  Higher HIV RNA molecular diversity in the genital tract (as compared to blood plasma), and evidence of compartmentalization illustrate the distinct evolutionary dynamics between these two compartments after ART interruption. Future research should evaluate whether the genital compartment might contribute to viral rebound in some PWH interrupting ART. Importance.  To cure HIV, we likely need to target the reservoirs in all anatomic compartments. Here, we used sophisticated statistical and phylogenetic methods to analyze blood and semen samples collected from 12 persons with HIV who began antiretroviral therapy (ART) during very early HIV-infection and who interrupted their ART as part of a clinical trial. First, we found that HIV RNA rebound in semen occurred significantly later and reached lower levels, as compared to blood. Second, we found that the virus in semen was genetically different in some participants, as compared to blood. Finally, we found increased HIV RNA molecular diversity in semen compared to blood in almost all study participants. These data suggest that the HIV RNA populations emerging from the genital compartment after ART interruption might not be the same as those emerging from blood plasma. Future research should evaluate whether the genital compartment might contribute to viral rebound in some PWH interrupting ART.",2020,"Despite early ART initiation, HIV RNA molecular diversity was higher in semen compared to blood in all three coding regions for most participants.","['clinical trial in people with HIV (PWH) who began ART during acute or early infection (NCT01859325', '12 individuals enrolled', '12 persons with HIV who began antiretroviral therapy (ART) during very early HIV-infection and who interrupted their ART as part of a clinical trial']","['placebo-controlled therapeutic vaccine', 'antiretroviral therapy (ART']","['sequenced HIV-1  env  ( C2-V3 ),  gag (p24),  and  pol ( reverse transcriptase) regions amplified from cell-free HIV RNA in blood and seminal plasma', 'viral population structure, compartmentalization and viral diversity in blood and seminal plasma', 'HIV RNA rebound in semen', 'blood, HIV RNA rebound in semen', 'HIV RNA molecular diversity']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042210', 'cui_str': 'Vaccine'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0017343', 'cui_str': 'ENV gene'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0035379', 'cui_str': 'RNA-directed DNA polymerase'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0242499', 'cui_str': 'Seminal plasma'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0877595', 'cui_str': 'HIV RNA rebound'}]",5.0,0.115519,"Despite early ART initiation, HIV RNA molecular diversity was higher in semen compared to blood in all three coding regions for most participants.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gianella', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA gianella@ucsd.edu.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Chaillon', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Tae-Wook', 'Initials': 'TW', 'LastName': 'Chun', 'Affiliation': 'National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Sneller', 'Affiliation': 'National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ignacio', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Milenka V', 'Initials': 'MV', 'LastName': 'Vargas-Meneses', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Caballero', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Ellis', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Kovacs', 'Affiliation': 'Maple Leaf Medical Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Benko', 'Affiliation': 'Maple Leaf Medical Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Huibner', 'Affiliation': 'Maple Leaf Medical Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Kaul', 'Affiliation': 'Maple Leaf Medical Clinic, Toronto, Ontario, Canada.'}]",Journal of virology,['10.1128/JVI.00415-20']
2733,32434932,Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach.,"OBJECTIVES


To evaluate adherence and acceptability of intermittent vaginal probiotic or antibiotic use to prevent bacterial vaginosis (BV) recurrence.
DESIGN


Repeated adherence and acceptability assessments using mixed methods within a pilot randomised controlled trial.
SETTING


Research clinic in Kigali, Rwanda.
PARTICIPANTS


Rwandan women with high sexual risk.
INTERVENTIONS


Women diagnosed with BV and/or trichomoniasis were randomised to four groups (n=17 each) after completing metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi+ (EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet.
OUTCOME MEASURES


Adherence and acceptability were assessed by structured face-to-face interviews, semi-structured focus group discussions and in-depth interviews, daily diaries and counting of used/unused study products in randomised women (n=68). Vaginal infection knowledge was assessed by structured face-to-face interviews in randomised women and women attending recruitment sessions (n=131).
RESULTS


Most women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics. All probiotic users (n=32) reported that insertion became easier over time. Triangulated adherence data showed that 17/17 EF+ users and 13/16 GynLP users used ≥80% of required doses (Fisher's exact p=0.103). Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence. Women believed that the probiotics reduced BV recurrence, but reported that partners were sometimes unsupportive of study participation. Self-reported vaginal washing practices decreased during follow-up, but sexual risk behaviours did not. Most women (12/15) with an uncircumcised steady partner discussed penile hygiene with him, but many women found this difficult, especially with male clients.
CONCLUSIONS


High-risk women require education about vaginal infections. Vaginal probiotic acceptability and adherence were high in this cohort. Our results can be used to inform future product development and to fine-tune counselling messages in prevention programmes.
TRIAL REGISTRATION NUMBER


NCT02459665.",2020,"Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence.","['Research clinic in Kigali, Rwanda', 'randomised women and women attending recruitment sessions (n=131', 'Rwandan women with high sexual risk participating', 'Rwandan women with high sexual risk', 'Women diagnosed with BV and/or trichomoniasis', 'Most women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics']","['EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet', 'intermittent vaginal probiotic or antibiotic', 'metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi']","['Self-reported vaginal washing practices', 'Vaginal probiotic adherence and acceptability', 'Vaginal infection knowledge', 'sexual risk behaviours', 'Adherence and acceptability', 'BV recurrence', 'Vaginal probiotic acceptability and adherence', 'reporting urogenital symptoms']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0040921', 'cui_str': 'Infection by Trichomonas'}, {'cui': 'C0240816', 'cui_str': 'Sex worker'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C1273011', 'cui_str': 'Vaginal capsule'}, {'cui': 'C0042264', 'cui_str': 'Vaginal tablet'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0360345', 'cui_str': 'Metronidazole-containing product in oral dose form'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0404521', 'cui_str': 'Infective vaginitis'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.22675,"Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence.","[{'ForeName': 'Marijn C', 'Initials': 'MC', 'LastName': 'Verwijs', 'Affiliation': 'Department of Clinical Infection, Microbiology and Immunology, Institute of Infection and Global Health, University of Liverpool, Liverpool, Merseyside, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Agaba', 'Affiliation': 'Rinda Ubuzima, Kigali, Rwanda.'}, {'ForeName': 'Marie Michele', 'Initials': 'MM', 'LastName': 'Umulisa', 'Affiliation': 'Rinda Ubuzima, Kigali, Rwanda.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Uwineza', 'Affiliation': 'Rinda Ubuzima, Kigali, Rwanda.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Nivoliez', 'Affiliation': 'Biose, Aurillac, France.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Lievens', 'Affiliation': 'Winclove, Amsterdam, The Netherlands.'}, {'ForeName': 'Janneke H H M', 'Initials': 'JHHM', 'LastName': 'van de Wijgert', 'Affiliation': 'Department of Clinical Infection, Microbiology and Immunology, Institute of Infection and Global Health, University of Liverpool, Liverpool, Merseyside, UK j.vandewijgert@liverpool.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-031819']
2734,32429379,"The Effect of a Family-Based Lifestyle Education Program on Dietary Habits, Hepatic Fat and Adiposity Markers in 8-12-Year-Old Children with Overweight/Obesity.","Healthy lifestyle education programs are recommended for obesity prevention and treatment. However, there is no previous information on the effects of these programs on the reduction of hepatic fat percentage. The aims were (i) to examine the effectiveness of a 22-week family-based lifestyle education program on dietary habits, and (ii) to explore the associations of changes in dietary intake with percent hepatic fat reduction and adiposity in children with overweight/obesity. A total of 81 children with overweight/obesity (aged 10.6 ± 1.1 years, 53.1% girls) and their parents attended a 22-week family based healthy lifestyle and psychoeducational program accompanied with (intensive group) or without (control) an exercise program. Hepatic fat (magnetic resonance imaging), adiposity (dual energy X-ray absorptiometry) and dietary habits (two non-consecutive 24 h-recalls) were assessed before and after the intervention. Energy ( p  < 0.01) fat ( p  < 0.01) and added sugar ( p  < 0.03) intake were significantly reduced in both groups at the end of the program, while, in addition, carbohydrates intake ( p  < 0.04) was reduced exclusively in the control group, and simple sugar ( p  < 0.05) and cholesterol ( p  < 0.03) intake was reduced in the exercise group. Fruit ( p  < 0.03) and low-fat/skimmed dairy consumption ( p  < 0.02), the adherence to the Mediterranean Diet Quality Index for children and teenagers (KIDMED,  p  < 0.01) and breakfast quality index ( p  < 0.03) were significantly higher in both control and intervention groups after the intervention. Moreover, participants in the exercise group increased the adherence to the Dietary Approaches to Stop Hypertension (DASH) diet ( p  < 0.001), whereas the ratio of evening-morning energy intake was significantly lower exclusively in the control group after the program ( p  < 0.02). Changes in energy intake were significantly associated with changes in fat mass index (FMI) in the exercise group, whereas changes in sugar-sweetened beverages (SSB) consumption was associated with percent hepatic fat reduction ( p  < 0.05) in the control group. A 22-week family-based healthy lifestyle program seems to be effective on improving diet quality and health in children with overweight/obesity and these should focus on SSB avoidance and physical activity.",2020,"p  < 0.02), the adherence to the Mediterranean Diet Quality Index for children and teenagers (KIDMED,  ","['81 children with overweight/obesity (aged 10.6 ± 1.1 years, 53.1% girls) and their parents attended a 22-week family based healthy lifestyle and', '8-12-Year-Old Children with Overweight/Obesity', 'children with overweight/obesity']","['22-week family-based lifestyle education program', 'added sugar ', 'psychoeducational program accompanied with (intensive group) or without (control) an exercise program', 'Family-Based Lifestyle Education Program']","['adherence to the Dietary Approaches to Stop Hypertension (DASH) diet', 'adherence to the Mediterranean Diet Quality Index', 'ratio of evening-morning energy intake', 'fat mass index (FMI', 'cholesterol', 'breakfast quality index', 'changes in sugar-sweetened beverages (SSB) consumption', 'diet quality and health', 'Hepatic fat (magnetic resonance imaging), adiposity (dual energy X-ray absorptiometry) and dietary habits', 'carbohydrates intake', 'Dietary Habits, Hepatic Fat and Adiposity Markers', 'hepatic fat reduction', 'energy intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",81.0,0.0124975,"p  < 0.02), the adherence to the Mediterranean Diet Quality Index for children and teenagers (KIDMED,  ","[{'ForeName': 'Lide', 'Initials': 'L', 'LastName': 'Arenaza', 'Affiliation': 'Institute for Innovation and Sustainable Development in Food Chain (IS-FOOD), Public University of Navarra, Calle Tajonar 22, 31006 Pamplona, Navarra, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Medrano', 'Affiliation': 'Institute for Innovation and Sustainable Development in Food Chain (IS-FOOD), Public University of Navarra, Calle Tajonar 22, 31006 Pamplona, Navarra, Spain.'}, {'ForeName': 'Maddi', 'Initials': 'M', 'LastName': 'Oses', 'Affiliation': 'Institute for Innovation and Sustainable Development in Food Chain (IS-FOOD), Public University of Navarra, Calle Tajonar 22, 31006 Pamplona, Navarra, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Amasene', 'Affiliation': 'Department of Pharmacy and Food Sciences, University of the Basque Country, UPV/EHU, 01006 Vitoria-Gasteiz, Araba, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Díez', 'Affiliation': 'Pediatric Endocrinology Unit, University Hospital of Araba (HUA), 01009 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Rodríguez-Vigil', 'Affiliation': 'Department of Magnetic Resonance Imaging, Osatek, University Hospital of Araba (HUA), 01009 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Idoia', 'Initials': 'I', 'LastName': 'Labayen', 'Affiliation': 'Institute for Innovation and Sustainable Development in Food Chain (IS-FOOD), Public University of Navarra, Calle Tajonar 22, 31006 Pamplona, Navarra, Spain.'}]",Nutrients,['10.3390/nu12051443']
2735,32429738,"A double-blind, randomized, multicenter, controlled study to evaluate the immunogenicity, safety, and tolerability of varicella vaccine (VARIVAX™) passage extension 34 (PE34) process administered concomitantly with measles, mumps, and rubella vaccine (M-M-R™ II).","The varicella vaccine passage extension (VAR-PE) process was undertaken to extend the availability of varicella zoster virus (VZV)-containing vaccines. This study (V210-A03; NCT03239873) assessed the immunogenicity, safety, and tolerability of VAR-PE process in comparison with varicella vaccine commercial product 2016 (VAR) randomized 1:1 in 600 healthy children 12 to 23 months of age administered concomitantly with measles-mumps-rubella (MMR) vaccine. The VZV seroconversion rate at 6 weeks Postdose 1 in the PP population was 100% for both groups. VZV antibody response rates and GMTs of VZV antibodies to VAR-PE induced and were non-inferior to those induced by VAR 6 weeks Postdose 1. From Day 1 through Day 42, adverse events (AEs) were reported by 81.3% of participants Postdose 1 and 67.9% Postdose 2. From Day 1 through Day 42 Postdose 1, injection-site AEs related to varicella vaccine were reported by 31.1% and 29.7% of participants in VAR-PE and VAR, respectively, and Postdose 2, by 25.7% and 25.5% of participants in the VAR-PE and VAR groups, respectively. Systemic AEs were generally comparable for the 2 vaccination groups, with the exception of pyrexia and otitis media higher in VAR-PE, and diarrhea and teething higher in VAR. The incidence of systemic AEs was generally lower Postdose 2 compared with Postdose 1.",2020,VZV antibody response rates and GMTs of VZV antibodies to VAR-PE induced and were non-inferior to those induced by VAR 6 weeks,['comparison with varicella vaccine commercial product 2016 (VAR) randomized 1:1 in 600 healthy children 12 to 23\xa0months of age administered concomitantly with measles-mumps-rubella (MMR) vaccine'],"['varicella vaccine (VARIVAX™) passage extension 34 (PE34) process administered concomitantly with measles, mumps, and rubella vaccine (M-M-R™ II']","['VZV seroconversion rate', 'immunogenicity, safety, and tolerability', 'pyrexia and otitis media higher in VAR-PE, and diarrhea and teething higher in VAR', 'Systemic AEs', 'incidence of systemic AEs', 'adverse events (AEs', 'immunogenicity, safety, and tolerability of VAR-PE process']","[{'cui': 'C0078048', 'cui_str': 'Varicella virus vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0025007', 'cui_str': 'Measles'}, {'cui': 'C0035920', 'cui_str': 'Rubella'}]","[{'cui': 'C0078048', 'cui_str': 'Varicella virus vaccine'}, {'cui': 'C0947706', 'cui_str': 'Varivax'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0025007', 'cui_str': 'Measles'}, {'cui': 'C0035923', 'cui_str': 'Rubella virus vaccine'}]","[{'cui': 'C0042338', 'cui_str': 'Human herpesvirus 3'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0029882', 'cui_str': 'Otitis media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0039437', 'cui_str': 'Teething syndrome'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",600.0,0.296599,VZV antibody response rates and GMTs of VZV antibodies to VAR-PE induced and were non-inferior to those induced by VAR 6 weeks,"[{'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Silas', 'Affiliation': 'Wee Care Pediatrics, Syracuse, UT, USA.'}, {'ForeName': 'Edward N', 'Initials': 'EN', 'LastName': 'Zissman', 'Affiliation': ""Children's Research at Altamonte Pediatric Associates, Lake Mary, FL, USA.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Gardner', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Shanjun', 'Initials': 'S', 'LastName': 'Helian', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Lee', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Platt', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1743122']
2736,32434291,The effect of preoperative dexmedetomidine nebulization on the hemodynamic response to laryngoscopy and intubation: a randomized control trial.,"Background


Dexmedetomidine, an alpha-2 agonist, has been used for attenuation of hemodynamic response to laryngoscopy, but not through the nebulized route. The aims of this study were to evaluate the effect of preoperative dexmedetomidine nebulization on the hemodynamic response to laryngoscopy-intubation, intraoperative anesthetic-analgesic requirements and recovery outcomes.
Methods


120 ASA I & II adult patients, of either gender, undergoing elective surgeries requiring tracheal intubation were enrolled and randomized to receive nebulized dexmedetomidine (1 µg/kg in 3-4 ml of 0.9% saline) or 0.9% saline (3-4 ml), 30 minutes before anesthesia induction. Heart rate and non-invasive systolic blood pressures were studied for 10 minutes following laryngoscopy.
Results


After laryngoscopy, linear mixed effect modelling showed significantly lower trend of increase in heart rate in the dexmedetomidine group versus saline (P = 0.01). However, there was no difference in the systolic blood pressure changes between the two groups (P= 0.90). Induction dose of propofol (P < 0.001), intraoperative fentanyl consumption (P = 0.007) and isoflurane requirements (P = 0.01) were significantly lower in the dexmedetomidine group. There was no difference in the 2-hr postoperative nausea and vomiting (PONV) (P = 0.61) or sore-throat (P = 0.74).
Conclusions


Nebulized dexmedetomidine 1 µg/kg attenuated the increase in heart rate but not systolic blood pressures following laryngoscopy; and reduced the intraoperative anesthetic and analgesic consumption. There was no effect on early PONV, sore-throat or increase in incidence of adverse effects. Nebulized dexmedetomidine may represent a favorable alternative to the intravenous route in short duration surgeries.",2020,"There was no difference in the 2-hr postoperative nausea and vomiting (PONV) (P = 0.61) or sore-throat (P = 0.74).
","['120 ASA I & II adult patients, of either gender, undergoing elective surgeries requiring tracheal intubation']","['nebulized dexmedetomidine (1 µg/kg in 3-4 ml of 0.9% saline) or 0.9% saline', 'Dexmedetomidine', 'Nebulized dexmedetomidine', 'dexmedetomidine nebulization', 'preoperative dexmedetomidine nebulization', 'propofol', 'dexmedetomidine']","['2-hr postoperative nausea and vomiting (PONV', 'Heart rate and non-invasive systolic blood pressures', 'early PONV, sore-throat or increase in incidence of adverse effects', 'systolic blood pressure changes', 'intraoperative anesthetic and analgesic consumption', 'heart rate', 'isoflurane requirements', 'intraoperative fentanyl consumption', 'sore-throat', 'hemodynamic response', 'systolic blood pressures']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428881', 'cui_str': 'Non-invasive systolic arterial pressure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",120.0,0.289014,"There was no difference in the 2-hr postoperative nausea and vomiting (PONV) (P = 0.61) or sore-throat (P = 0.74).
","[{'ForeName': 'Satyajeet', 'Initials': 'S', 'LastName': 'Misra', 'Affiliation': 'The Departments of Anesthesiology & Critical Care & Pharmacology + All India Institute of Medical Sciences (AIIMS), Bhubaneswar Odisha, India.'}, {'ForeName': 'Bikram Kishore', 'Initials': 'BK', 'LastName': 'Behera', 'Affiliation': 'The Departments of Anesthesiology & Critical Care & Pharmacology + All India Institute of Medical Sciences (AIIMS), Bhubaneswar Odisha, India.'}, {'ForeName': 'Jayanta Kumar', 'Initials': 'JK', 'LastName': 'Mitra', 'Affiliation': 'The Departments of Anesthesiology & Critical Care & Pharmacology + All India Institute of Medical Sciences (AIIMS), Bhubaneswar Odisha, India.'}, {'ForeName': 'Alok Kumar', 'Initials': 'AK', 'LastName': 'Sahoo', 'Affiliation': 'The Departments of Anesthesiology & Critical Care & Pharmacology + All India Institute of Medical Sciences (AIIMS), Bhubaneswar Odisha, India.'}, {'ForeName': 'Sritam Swarup', 'Initials': 'SS', 'LastName': 'Jena', 'Affiliation': 'The Departments of Anesthesiology & Critical Care & Pharmacology + All India Institute of Medical Sciences (AIIMS), Bhubaneswar Odisha, India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Srinivasan', 'Affiliation': 'The Departments of Anesthesiology & Critical Care & Pharmacology + All India Institute of Medical Sciences (AIIMS), Bhubaneswar Odisha, India.'}]",Korean journal of anesthesiology,['10.4097/kja.20153']
2737,32434296,[Application of Single-hole Thoracoscopic Surgery Combined with ERAS Concept for Respiratory Function Exercise in Perioperative Period of Lung Cancer].,"BACKGROUND


The aim of this study is to explore the effects of enhanced recovery after surgery (ERAS) combined with respiratory function exercise combined with single-hole thoracoscopic surgery on lung cancer patients with postoperative pulmonary complications, postoperative pain, time to get out of bed, time to extubation, and length of hospital stay.
METHODS


A total of 240 patients who underwent endoscopic lung cancer surgery at the Affiliated Hospital of Yangzhou University and the Yancheng First People's Hospital from October 2017 to October 2019 were randomly divided into 4 groups, with 60 patients in each group. Patients in group A underwent single-hole thoracoscopic surgery, and preoperatively performed ERAS concept education and respiratory function training; group B used conventional 3-hole thoracoscopic surgery, and performed ERAS concept education and respiratory function training before operation; group C used conventional 3-hole thoracoscopic operation Surgery, routine hospitalization education and nursing guidance, routine respiratory function training, no preoperative ERAS concept education; group D used single-hole thoracoscopic surgery, routine hospitalization education and nursing guidance, routine respiratory function training, no preoperative ERAS Concept mission. The number of postoperative pulmonary complications, postoperative pain, time to get out of bed, extubation time, and hospital stay were recorded in the four groups.
RESULTS


Compared with the groups B, C, and D, the incidence of pulmonary complications was significantly reduced, and the time to get out of bed, extubation time, and hospital stay were significantly shortened in group A. Compared with groups B, C, the postoperative pain was significantly reduced in group A. Compared with group C, the pulmonary complications were significantly reduced, and the time to get out of bed, extubation time and hospital stay were significantly shortened in group B. The differences were statistically significant (P<0.05). There was no significant difference in postoperative pain between group A and group D, group B and group C (P>0.05).
CONCLUSIONS


For patients with single-hole thoracoscopic lung cancer surgery, the ERAS concept guidance can effectively reduce the incidence of pulmonary complications and postoperative pain, shorten the time to get out of bed, the time to extubate, and the length of hospital stay.",2020,"There was no significant difference in postoperative pain between group A and group D, group B and group C (P>0.05).
","['lung cancer patients with postoperative pulmonary complications', 'patients with single-hole thoracoscopic lung cancer surgery', 'Perioperative Period of Lung Cancer', ""240 patients who underwent endoscopic lung cancer surgery at the Affiliated Hospital of Yangzhou University and the Yancheng First People's Hospital from October 2017 to October 2019""]","['single-hole thoracoscopic surgery, and preoperatively performed ERAS concept education and respiratory function training; group B used conventional 3-hole thoracoscopic surgery, and performed ERAS concept education and respiratory function training before operation; group C used conventional 3-hole thoracoscopic operation Surgery, routine hospitalization education and nursing guidance, routine respiratory function training, no preoperative ERAS concept education; group D used single-hole thoracoscopic surgery, routine hospitalization education and nursing guidance, routine respiratory function training, no preoperative ERAS Concept mission', 'Single-hole Thoracoscopic Surgery Combined with ERAS Concept for Respiratory Function Exercise', 'surgery (ERAS) combined with respiratory function exercise combined with single-hole thoracoscopic surgery']","['postoperative pain, time to get out of bed, time to extubation, and length of hospital stay', 'time to get out of bed, extubation time, and hospital stay', 'postoperative pain', 'time to get out of bed, extubation time and hospital stay', 'pulmonary complications', 'incidence of pulmonary complications', 'number of postoperative pulmonary complications, postoperative pain, time to get out of bed, extubation time, and hospital stay']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",240.0,0.0207493,"There was no significant difference in postoperative pain between group A and group D, group B and group C (P>0.05).
","[{'ForeName': 'Qingtong', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Department of Thoracic Surgery, the Affiliated Hospital of Yangzhou University, Yangzhou 225000, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Diao', 'Affiliation': 'Department of Thoracic Surgery, the Affiliated Hospital of Yangzhou University, Yangzhou 225000, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': ""Department of Thoracic Surgery, Yancheng First People's Hospital, Yancheng 224000, China.""}]",Zhongguo fei ai za zhi = Chinese journal of lung cancer,['10.3779/j.issn.1009-3419.2020.101.26']
2738,32434372,Efficacy of a Short-Term Low-Calorie Diet in Overweight and Obese Patients with Chronic Sciatica: A Randomized Controlled Trial.,"Objectives:  Chronic sciatica is a common condition. According to Traditional Persian Medicine and recent studies, calorie reduction is thought to be helpful for this condition. The purpose of this work is to evaluate a short-term low-calorie diet (LCD) for ameliorating chronic sciatica in the context of pain relief and reduced disability for patients.  Design:  In this randomized controlled trial, 96 candidates for the nonsurgical treatment of chronic sciatica were randomly assigned to two groups to receive a 1-month LCD (intervention) or ordinary diet (control), both in combination with nonsteroidal anti-inflammatory drugs (NSAIDs). Afterward, patients were visited at baseline and on days 15, 30, and 60 after treatment. Pain and disability were evaluated using the short-form McGill pain questionnaire (SFMPQ) and the Roland-Morris disability questionnaire (RMDQ), respectively.  Results:  Both mean RMDQ scores and SFMPQ scores decreased significantly in the LCD group compared to the control group. SFMPQ descriptor scale scores at baseline and on days 15, 30, and 60 in the LCD group were 7.71 ± 1.69, 6.63 ± 1.61, 5.54 ± 1.87, and 4.96 ± 2.02, respectively, and in the control group were 6.63 ± 1.44, 6.69 ± 1.32, 6.64 ± 1.98, and 6.62 ± 2.53, respectively ( p  = 0.001). RMDQ scores at baseline and on days 15, 30, and 60 in LCD group were 11.17 ± 3.90, 8.60 ± 1.97, 7.50 ± 2.71, and 6.77 ± 3.06, respectively, and in the control group, 10.00 ± 2.20, 9.98 ± 2.29, 9.94 ± 2.94, and 9.85 ± 3.32, respectively ( p  < 0.001).  Conclusion:  A short-term (1-month) LCD is effective in decreasing pain and disability in candidates for nonsurgical treatment of chronic sciatica.",2020,Both mean RMDQ scores and SFMPQ scores decreased significantly in the LCD group compared to the control group.,"['patients', '96 candidates for the nonsurgical treatment of chronic sciatica', 'Overweight and Obese Patients with Chronic Sciatica']","['Short-Term Low-Calorie Diet', 'short-term low-calorie diet (LCD', 'LCD', 'LCD (intervention) or ordinary diet (control), both in combination with nonsteroidal anti-inflammatory drugs (NSAIDs']","['SFMPQ descriptor scale scores', 'pain and disability', 'mean RMDQ scores and SFMPQ scores', 'Pain and disability', 'short-form McGill pain questionnaire (SFMPQ) and the Roland-Morris disability questionnaire (RMDQ', 'RMDQ scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0585052', 'cui_str': 'Chronic sciatica'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C1690006', 'cui_str': 'Lattice corneal dystrophy Type I'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}]","[{'cui': 'C0282354', 'cui_str': 'Descriptor'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",96.0,0.0627435,Both mean RMDQ scores and SFMPQ scores decreased significantly in the LCD group compared to the control group.,"[{'ForeName': 'Mir Bahram', 'Initials': 'MB', 'LastName': 'Safari', 'Affiliation': 'Department of Orthopaedics, Imam University Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Aisan', 'Initials': 'A', 'LastName': 'Nozad', 'Affiliation': 'Department of Traditional Persian Medicine, School of Medicine, Shahed University, Tehran, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Ghaffari', 'Affiliation': 'School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Ghavamzadeh', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Alijaniha', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Naseri', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0360']
2739,32434490,Does growth hormone supplementation improve oocyte competence and IVF outcomes in patients with poor embryonic development? A randomized controlled trial.,"BACKGROUND


Many studies have demonstrated the benefits of the addition of growth hormone (GH) to the controlled ovarian stimulation protocol in vitro fertilization (IVF) cycles in poor-respond patients, but the effect of GH on patients with poor embryonic development remain unclear. This paper was designed to investigate the efficacy of GH co-treatment during IVF for the patients with poor embryonic development.
METHOD


A randomized controlled trial including 158 patients with poor embryo development was conducted between July 2017 and February 2019. One hundred and seven patients were randomized for GH treatment (GH group) and 51 patients for untreated (control group). The primary end-points were the clinical pregnancy and live birth rates in the two groups. The oocyte competence were assessed through calculating the mitochondrial DNA (mtDNA) copy number in corresponding cumulus granulosa cells (CGCs). Quantitative PCR were used for calculation of mtDNA copy number.
RESULTS


Relative to the control group, GH co-treatment resulted in a significantly higher number of retrieved oocytes (10.29 ± 5.92 versus 8.16 ± 4.17, P = 0.023) and cleaved embryos (6.73 ± 4.25 versus 5.29 ± 3.23, P = 0.036). The implantation rate, clinical pregnancy rates per cycle, and live birth rate per cycle were higher in the GH group than in the control group (36.00% versus 17.86%, P = 0.005; 43.93% versus 19.61%, P = 0.005; 41.12% versus 17.65%, P = 0.006). CGCs of the GH group had significantly higher mtDNA copy numbers than CGCs of the control group (252 versus 204, P < 0.001).
CONCLUSIONS


These data provided further evidence to indicate that GH supplementation may support more live births during IVF, in patients with poor embryonic development. It also appears that oocytes generated under GH co-treatment have a better developmental competence.
TRIAL REGISTRATION


ChiCTR1900021992 posted March 19, 2019 (retrospectively registered).",2020,"The implantation rate, clinical pregnancy rates per cycle, and live birth rate per cycle were higher in the GH group than in the control group (36.00% versus 17.86%, P = 0.005; 43.93% versus 19.61%, P = 0.005; 41.12% versus 17.65%, P = 0.006).","['158 patients with poor embryo development was conducted between July 2017 and February 2019', 'One hundred and seven patients', 'patients with poor embryonic development']","['growth hormone supplementation', 'GH supplementation', 'GH treatment (GH', 'growth hormone (GH']","['mitochondrial DNA (mtDNA) copy number in corresponding cumulus granulosa cells (CGCs', 'oocyte competence and IVF outcomes', 'clinical pregnancy and live birth rates', 'implantation rate, clinical pregnancy rates per cycle, and live birth rate per cycle', 'number of retrieved oocytes', 'cleaved embryos']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0013936', 'cui_str': 'Embryo Development'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1956101', 'cui_str': 'Granulosa Cells, Cumulus'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0205242', 'cui_str': 'Cleaved'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}]",158.0,0.122168,"The implantation rate, clinical pregnancy rates per cycle, and live birth rate per cycle were higher in the GH group than in the control group (36.00% versus 17.86%, P = 0.005; 43.93% versus 19.61%, P = 0.005; 41.12% versus 17.65%, P = 0.006).","[{'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Chongqing Key Laboratory of Human Embryo Engineering, Chongqing Reproduction and Genetics Institute, Chongqing Health Center for Women and Children, No.64 Jin Tang Street, Yu Zhong District, Chongqing, 400013, China.'}, {'ForeName': 'Qiaoli', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Chongqing Key Laboratory of Human Embryo Engineering, Chongqing Reproduction and Genetics Institute, Chongqing Health Center for Women and Children, No.64 Jin Tang Street, Yu Zhong District, Chongqing, 400013, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Chongqing Key Laboratory of Human Embryo Engineering, Chongqing Reproduction and Genetics Institute, Chongqing Health Center for Women and Children, No.64 Jin Tang Street, Yu Zhong District, Chongqing, 400013, China.'}, {'ForeName': 'Guoning', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': 'Chongqing Key Laboratory of Human Embryo Engineering, Chongqing Reproduction and Genetics Institute, Chongqing Health Center for Women and Children, No.64 Jin Tang Street, Yu Zhong District, Chongqing, 400013, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': 'Chongqing Key Laboratory of Human Embryo Engineering, Chongqing Reproduction and Genetics Institute, Chongqing Health Center for Women and Children, No.64 Jin Tang Street, Yu Zhong District, Chongqing, 400013, China. yehong1210@163.com.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03004-9']
2740,32434504,Implementation of an interactive organ donation education program for Dutch lower-educated students: a process evaluation.,"BACKGROUND


As organ donation registration rates remain low, especially among lower-educated people, it is important to support this group in making their registration decision. To prepare lower-educated students in the Netherlands for making a well-informed decision, an interactive educational program was developed. We aim to understand both the (quality of) implementation as well as to contextualize the effects of this program in a lower-educated school setting.
METHODS


The process evaluation was part of a Cluster Randomized Controlled Trial, in which 11 schools for Intermediate Vocational Education throughout the Netherlands participated. Teachers who taught a course on Citizenship delivered three intervention elements (i.e. video fragments and discussion, quizzes with tailored feedback and an exercise filling out a registration form) to their students. Implementation was assessed by interviews with teachers, questionnaires from students, logbooks from teachers and user data from Google Analytics.
RESULTS


The program was well received and implemented, but on-the-spot adaptations were made by teachers to fit their students better. Within the lower-educated target group, differences between students are high in terms of active participation, reading abilities, knowledge and attention span. The program fit well within their regular teaching activities, but the topic of organ donation is not always prioritized by teachers.
CONCLUSIONS


We see opportunities to disseminate the program on a larger scale and reach a group that has been neglected in organ donation education before. Within the program, there are possibilities to increase the effectiveness of the program, such as alternative delivery methods for the elements with a lot of text, the addition of booster sessions and guidelines for teachers to adapt the program to students of different levels within Intermediate Vocational Education. Moreover, in order to have an impact on a national level, strategies need to be employed to reach high numbers of students and, therefore, support on a higher level is needed (both within schools and at policy level).
TRIAL REGISTRATION


Dutch Trial Register, NTR6771. Prospectively registered on 24 October 2017.",2020,"Within the lower-educated target group, differences between students are high in terms of active participation, reading abilities, knowledge and attention span.","['11 schools for Intermediate Vocational Education throughout the Netherlands participated', 'Dutch lower-educated students', 'Prospectively registered on 24 October 2017']",['interactive organ donation education program'],"['active participation, reading abilities, knowledge and attention span']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0042933', 'cui_str': 'Vocational schooling'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0367916,"Within the lower-educated target group, differences between students are high in terms of active participation, reading abilities, knowledge and attention span.","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Steenaart', 'Affiliation': 'Department of Health Promotion, CAPHRI Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands. e.steenaart@maastrichtuniversity.nl.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Crutzen', 'Affiliation': 'Department of Health Promotion, CAPHRI Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands.'}, {'ForeName': 'Nanne K', 'Initials': 'NK', 'LastName': 'de Vries', 'Affiliation': 'Department of Health Promotion, CAPHRI Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands.'}]",BMC public health,['10.1186/s12889-020-08900-5']
2741,32434709,Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials.,"BACKGROUND


Recruitment of participants is crucial to the success of any trial as it can have a major impact on study costs, the duration of the study itself, and, more critically, trial failure. Given that vulvodynia particularly affects young women, the use of social media and e-recruitment could prove efficient for enrollment.
AIM


To compare the efficiency, effectiveness, and cost-effectiveness of three different recruitment methods.
METHODS


The comparison data were collected as part of a bicentric randomized controlled trial evaluating the efficacy of physiotherapy in comparison with topical lidocaine in 212 women suffering from provoked vestibulodynia. The recruitment methods included: (i) conventional methods (eg, posters, leaflets, business cards, newspaper ads); (ii) health professional referrals, and (iii) e-recruitment (eg, Facebook ads and web initiatives). Women interested in participating were screened by telephone for eligibility criteria and were assessed by a gynecologist to confirm their diagnosis. Once included, structured interviews were undertaken to describe their baseline characteristics.
MAIN OUTCOME MEASURES


The outcomes of this study were the recruitment efficiency (the number of patients screened/enrolled), recruitment effectiveness (the number of participants enrolled), cost-effectiveness (cost per enrolled participant), and retention rate, and baseline characteristics of participants were monitored for each method.
RESULTS


The conventional methods (n = 101, 48%) were more effective as they allowed for greater enrollment of participants, followed by e-recruitment (n = 60, 28%) and health professional referrals (n = 33, 16%) (P < 0.007). Recruitment efficiency was found to be similar for e-recruitment and referrals (60/122 and 33/67, 49%, P = 0.055) but lower for conventional methods (101/314, 32%, P < 0.011). Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588). The average cost per enrolled participant was fairly similar for e-recruitment ($117) and conventional methods ($110) and lower for referrals ($60).
CLINICAL IMPLICATIONS


Our results suggest that having a variety of recruitment methods is beneficial in promoting clinical trial recruitment without affecting participant characteristics and retention rates.
STRENGTH & LIMITATIONS


Although recruitment methods were used concomitantly, this study gives an excellent insight into the advantages and limitations of recruitment methods owing to a large sample size.
CONCLUSION


The study findings revealed that e-recruitment is a valuable recruitment method because of its comparable efficiency and cost-effectiveness to health professional referrals and conventional methods, respectively.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, number NCT01455350. Benoit-Piau J, Dumoulin C, Carroll MS, et al. Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials. J Sex Med 2020;XX:XXX-XXX.",2020,"Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588).",['212 women suffering from provoked vestibulodynia'],"['conventional methods (eg, posters, leaflets, business cards, newspaper ads', 'topical lidocaine']","['cost-effectiveness (cost per enrolled participant), and retention rate', 'Recruitment efficiency', 'health professional referrals', 'Efficiency and Cost', 'retention rate', 'efficiency, effectiveness, and cost-effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0269084', 'cui_str': 'Vulvar vestibulitis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",212.0,0.330363,"Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588).","[{'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Benoit-Piau', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, and Research Center, Centre hospitalier de l'Université de Sherbrooke (CHUS), Sherbrooke, QC, Canada.""}, {'ForeName': 'Chantale', 'Initials': 'C', 'LastName': 'Dumoulin', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal, and Research Center, Institut universitaire de gériatrie de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Marie-Soleil', 'Initials': 'MS', 'LastName': 'Carroll', 'Affiliation': ""Faculty of Medicine and Health Sciences, Université de Sherbrooke, and Research Center, Centre hospitalier de l'Université de Sherbrooke (CHUS), Sherbrooke, QC, Canada.""}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Mayrand', 'Affiliation': ""Departments of Obstetrics and Gynecology and Social and Preventive Medicine, Université de Montréal, and Research Center, Centre hospitalier de l'Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bergeron', 'Affiliation': 'Department of Psychology, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Khalifé', 'Affiliation': 'Jewish General Hospital and Royal Victoria Hospital, McGill University Health Center, Montréal, QC, Canada.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Waddell', 'Affiliation': 'Department of Obstetrics and Gynecology, CHUS and Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Morin', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Research Center, Centre hospitalier de l'Université de Sherbrooke (CHUS), Sherbrooke, QC, Canada. Electronic address: melanie.m.morin@usherbrooke.ca.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.04.005']
2742,32434744,Risk for Delayed Graft Function in Deceased Donor Renal Transplant Patients: A Single-Center Experience From North India.,"OBJECTIVES


Delayed graft function (DGF) in renal allograft transplantation refers to the need for dialysis in the first week after renal transplantation. This study analyzed the causes of DGF in deceased donor transplantation.
METHODS


Data from January 2018 to July 2019 was reviewed with regard to donor and recipient characteristics such as demographics, biochemical parameters, organ dysfunction, and preterminal management. The recipients were divided into 2 groups: group I: patients without DGF and group II: patients with DGF.
RESULTS


Kidneys were retrieved from 49 deceased donors (male:female = 41:8) and transplanted to 95 recipients (male:female = 60:35). Mean age of the donors and recipients was 35.34 ± 18.2 and 40.72 ± 13.30 years, respectively. The most common cause of brain death was central nervous system trauma (45 out of 49, 91%). In total, 20/95 (21%) recipients had DGF. Twelve recipients had received kidneys from donors who had circulatory arrest. Two patients were re-explored on postoperative day 1 for bleeding from renal artery anastomosis. The mean age in group I and group II was 28.65 ± 10.2 and 37.38 ± 12.28 years, respectively. The mean cold ischemia time in group I and group II was 398.73 ± 187.19 and 333.24 ± 115.49 minutes, respectively. The mean hospital stay of donor before donation in group I and group II was 4.34 ± 1.27 and 6 ± 2.95 days, respectively. The terminal donor creatinine in group I and group II was 0.88 ± 0.47 and 2.33 ± 1.73 mg/dL, respectively.
CONCLUSION


DGF in deceased donor transplantation may be attributed to donation after circulatory death, prolonged donor hospital stay, high donor leukocyte count, and high terminal creatinine.",2020,"The mean hospital stay of donor before donation in group I and group II was 4.34 ± 1.27 and 6 ± 2.95 days, respectively.","['Mean age of the donors and recipients was 35.34 ± 18.2 and 40.72 ± 13.30 years, respectively', 'Deceased Donor Renal Transplant Patients', 'Data from January 2018 to July 2019 was reviewed with regard to donor and recipient characteristics such as demographics, biochemical parameters, organ dysfunction, and preterminal management', 'deceased donor transplantation', 'Twelve recipients had received kidneys from donors who had circulatory arrest', 'Kidneys were retrieved from 49 deceased donors (male:female\xa0= 41:8) and transplanted to 95 recipients (male:female\xa0= 60:35', 'and group II: patients with DGF']","['Delayed graft function (DGF', 'DGF']","['mean hospital stay of donor before donation', 'mean cold ischemia time']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0730392', 'cui_str': 'Donor renal transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0444720', 'cui_str': 'Circulatory arrest'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1566590', 'cui_str': 'Delayed graft function'}]","[{'cui': 'C1566590', 'cui_str': 'Delayed graft function'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C1563922', 'cui_str': 'Cold Ischemic Time'}]",2.0,0.0250709,"The mean hospital stay of donor before donation in group I and group II was 4.34 ± 1.27 and 6 ± 2.95 days, respectively.","[{'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Seth', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Deepesh Benjamin', 'Initials': 'DB', 'LastName': 'Kenwar', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Shivakumar S', 'Initials': 'SS', 'LastName': 'Patil', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Gaurav Shankar', 'Initials': 'GS', 'LastName': 'Pandey', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Vidyasagar', 'Initials': 'V', 'LastName': 'Kallepalli', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sahil', 'Initials': 'S', 'LastName': 'Rally', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Thakur', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Milind', 'Initials': 'M', 'LastName': 'Mandwar', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sarbpreet', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India. Electronic address: drsarbpreet@yahoo.com.'}]",Transplantation proceedings,['10.1016/j.transproceed.2020.04.003']
2743,32429720,Immunotherapy in patients with local HPV infection and high-grade squamous intraepithelial lesion following uterine cervical conization.,"Objective:  To establish the clearance of cervical human papillomavirus (HPV) infection following postoperative immunotherapy with inosine pranobex in women receiving surgical treatment of established high-grade squamous intraepithelial lesion (HSIL) of the uterine cervix. Materials and methods:  Over the six-year study period, 32 women with cervical HPV infection following electroconization (loop electrosurgical excision procedure) of the uterine cervix for established HSIL were randomly divided into two groups: I ( n  = 10) without and II ( n  = 22) with postoperative inosine pranobex immunotherapy. Follow-up after 24 and 48 months included cervical testing for HPV persistence and after 12, 24, and 48 months with cytology and colposcopy for dysplasia relapse (confirmed histologically). Results:  Relapse monitoring in 32 women after 12 months revealed 1 and 0 HSIL positive in groups I and II, respectively; after 24 months an additional 3 patients in each group were positive; and after 48 months an additional 3 and 1 patients were positive in groups I and II, respectively ( p  < .05). The groups significantly differed ( p  < .05) with regard to clearing the most common high-risk HPV genotypes (HPV 16 and HPV 56). Conclusions:  Inosine pranobex immunotherapy in HPV-positive patients following cervical conization significantly increased the clearance of viral infection with high-risk genotypes and reduced relapse of HSIL.",2020,The groups significantly differed ( p  < .05) with regard to clearing the most common high-risk HPV genotypes (HPV 16 and HPV 56).,"['32 women with cervical HPV infection following electroconization (loop electrosurgical excision procedure) of the uterine cervix for established HSIL', 'patients with local HPV infection and high-grade squamous intraepithelial lesion following uterine cervical conization', 'women receiving surgical treatment of established high-grade squamous intraepithelial lesion (HSIL) of the uterine cervix']","['Immunotherapy', 'postoperative inosine pranobex immunotherapy', 'postoperative immunotherapy with inosine pranobex']","['clearance of viral infection', 'relapse of HSIL', '0 HSIL positive']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0333875', 'cui_str': 'High-grade squamous intraepithelial lesion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0195324', 'cui_str': 'Cone biopsy of cervix'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022230', 'cui_str': 'Inosine Pranobex'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0333875', 'cui_str': 'High-grade squamous intraepithelial lesion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",32.0,0.0411971,The groups significantly differed ( p  < .05) with regard to clearing the most common high-risk HPV genotypes (HPV 16 and HPV 56).,"[{'ForeName': 'Stefan Miladinov', 'Initials': 'SM', 'LastName': 'Kovachev', 'Affiliation': 'Department of Gynecology, Military Medical Academy, Sofia, Bulgaria.'}]",Immunopharmacology and immunotoxicology,['10.1080/08923973.2020.1765374']
2744,32429848,A randomized trial of mail and email recruitment strategies for a physician survey on clinical trial accrual.,"BACKGROUND


Patient participation in cancer clinical trials is suboptimal. A challenge to capturing physicians' insights about trials has been low response to surveys. We conducted a study using varying combinations of mail and email to recruit a nationally representative sample of medical, surgical, and radiation oncologists to complete a survey on trial accrual.
METHODS


We randomly assigned eligible physicians identified from the American Medical Association MasterFile (n = 13,251) to mail- or email-based recruitment strategies. Mail-based recruitment included a survey packet with: (1) cover letter describing the survey and inviting participation; (2) paper copy of the survey and postage-paid return envelope; and (3) a web link for completing the survey online. Email-based recruitment included an e-mail describing the survey and inviting participation, along with the web link to the survey, and a reminder postcard 2 weeks later.
RESULTS


Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment. In email-based recruitment, only one-quarter of recipients opened the email, and even fewer clicked on the link to complete the survey. Most physicians in mail-based recruitment responded after the first invitation (362 of 770 responders, 47.0%). A higher proportion of responders vs. non-responders were young (ages 25-44 years), men, and radiation or surgical (vs. medical) oncologists.
CONCLUSIONS


Most physicians assigned to mail-based recruitment actually completed the survey online via the link provided in the cover letter, and those in email-based recruitment did not respond until they received a reminder postcard by mail. Providing the option to return a paper survey or complete it online may have further increased participation in the mail-based group, and future studies should examine how combinations of delivery mode and return options affect physicians' response to surveys.",2020,"RESULTS


Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment.","['A higher proportion of responders vs. non-responders were young (ages 25-44\u2009years), men, and radiation or surgical (vs. medical) oncologists']","['Mail-based recruitment included a survey packet with: (1) cover letter describing the survey and inviting participation; (2) paper copy of the survey and postage-paid return envelope; and (3) a web link for completing the survey online', 'mail and email recruitment strategies', 'American Medical Association MasterFile (n\u2009=\u200913,251) to mail- or email-based recruitment strategies']",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1641805', 'cui_str': 'Packet - unit of product usage'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0002461', 'cui_str': 'AMA - American Medical Association'}]",[],,0.0660322,"RESULTS


Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment.","[{'ForeName': 'Caitlin C', 'Initials': 'CC', 'LastName': 'Murphy', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA. caitlin.murphy@utsouthwestern.edu.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Craddock Lee', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Geiger', 'Affiliation': 'Healthcare Delivery Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Cox', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Chul', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Rasmi', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Halm', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'McCallister', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Celette Sugg', 'Initials': 'CS', 'LastName': 'Skinner', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}]",BMC medical research methodology,['10.1186/s12874-020-01014-x']
2745,32434370,Comparison of the effects of general and local anesthesia in lumbar interlaminar endoscopic surgery.,"BACKGROUND


Percutaneous endoscopic lumbar discectomy (PELD) with an interlaminar approach is a technique used to treat lumbar disc hernia. It has not yet been established whether general or local anesthesia (LA) is preferable for lumbar interlaminar endoscopic surgery.
METHODS


Between October, 2012 and June, 2016, 60 patients were recruited and randomly divided into 2 groups: the general anesthesia (GA) group and the LA group. The patients' basic clinical data, intraoperative patient experience, Oswestry disability index (ODI), visual analog scale (VAS) score, and the postoperative patient satisfaction rate were assessed.
RESULTS


Statistically significant differences were found between the two groups in operative time and length of hospital stay. There were no significant differences in postoperative ODI or VAS scores between the two groups during follow-up at 3, 6, and 12 months. One patient in the GA group sustained a nerve root injury intraoperatively. Two patients in the LA group suffered adverse reactions, as did six patients in the GA group. However, 50% of the patients expressed fear about undergoing the surgery with LA, while all patients felt they could undergo the same surgery with GA.
CONCLUSIONS


General and LA are both suitable for use in lumbar interlaminar endoscopic surgery. However, GA makes a positive intraoperative surgical experience more likely for the patient.",2020,"There were no significant differences in postoperative ODI or VAS scores between the two groups during follow-up at 3, 6, and 12 months.","['lumbar interlaminar endoscopic surgery', 'Between October, 2012 and June, 2016', '60 patients', 'lumbar disc hernia']","['GA', 'local anesthesia (LA', 'Percutaneous endoscopic lumbar discectomy (PELD', 'general anesthesia (GA) group and the LA', 'LA', 'general and local anesthesia']","['intraoperative patient experience, Oswestry disability index (ODI), visual analog scale (VAS) score, and the postoperative patient satisfaction rate', 'adverse reactions', 'operative time and length of hospital stay', 'postoperative ODI or VAS scores']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",60.0,0.0380796,"There were no significant differences in postoperative ODI or VAS scores between the two groups during follow-up at 3, 6, and 12 months.","[{'ForeName': 'Xue-Fei', 'Initials': 'XF', 'LastName': 'Ye', 'Affiliation': ""Department of Anesthesiology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Ai-Min', 'Initials': 'AM', 'LastName': 'Wu', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Lin-Zheng', 'Initials': 'LZ', 'LastName': 'Xie', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Xiang-Yang', 'Initials': 'XY', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Jiao-Xiang', 'Initials': 'JX', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.""}, {'ForeName': 'Sun-Ren', 'Initials': 'SR', 'LastName': 'Sheng', 'Affiliation': ""Department of Orthopaedic Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China. shengsunren82330@126.com.""}]",Annals of palliative medicine,['10.21037/apm-20-623']
2746,32434574,Mismatch between self-perceived and calculated cardiometabolic disease risk among participants in a prevention program for cardiometabolic disease: a cross-sectional study.,"BACKGROUND


The rising prevalence of cardiometabolic diseases (CMD) calls for effective prevention programs. Self-assessment of CMD risk, for example through an online risk score (ORS), might induce risk reducing behavior. However, the concept of disease risk is often difficult for people to understand. Therefore, the study objective was to assess the impact of communicating an individualized CMD risk score through an ORS on perceived risk and to identify risk factors and demographic characteristics associated with risk perception among high-risk participants of a prevention program for CMD.
METHODS


A cross-sectional analysis of baseline data from a randomized controlled trial conducted in a primary care setting. Seven thousand five hundred forty-seven individuals aged 45-70 years without recorded CMD, hypertension or hypercholesterolemia participated. The main outcome measures were: 1) differences in cognitive and affective risk perception between the intervention group - who used an ORS and received an individualized CMD risk score- and the control group who answered questions about CMD risk, but did not receive an individualized CMD risk score; 2) risk factors and demographic characteristics associated with risk perception.
RESULTS


No differences were found in cognitive and affective risk perception between the intervention and control group and risk perception was on average low, even among high-risk participants. A positive family history for diabetes type 2 (β0.56, CI95% 0.39-0.73) and cardiovascular disease (β0.28, CI95% 0.13-0.43), BMI ≥25 (β0.27, CI95% 0.12-0.43), high waist circumference (β0.25, CI95% 0.02-0.48) and physical inactivity (β0.30, CI95% 0.16-0.45) were positively associated with cognitive CMD risk perception in high-risk participants. No other risk factors or demographic characteristics were associated with risk perception.
CONCLUSIONS


Communicating an individualized CMD risk score did not affect risk perception. A mismatch was found between calculated risk and self-perceived risk in high-risk participants. Family history and BMI seem to affect the level of CMD risk perception more than risk factors such as sex, age and smoking. A dialogue about personal CMD risk between patients and health care professionals might optimize the effect of the provided risk information.
TRIAL REGISTRATION


Dutch trial Register number NTR4277, registered 26th Nov 2013.",2020,"No differences were found in cognitive and affective risk perception between the intervention and control group and risk perception was on average low, even among high-risk participants.","['Seven thousand five hundred forty-seven individuals aged 45-70\u2009years without recorded CMD, hypertension or hypercholesterolemia participated', 'participants in a prevention program for cardiometabolic disease', 'high-risk participants of a prevention program for CMD']",[],"['high waist circumference', 'risk perception', 'cardiovascular disease', 'level of CMD risk perception', 'cognitive CMD risk perception', 'physical inactivity', 'cognitive and affective risk perception']","[{'cui': 'C4517869', 'cui_str': '7500'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}]",7547.0,0.0357281,"No differences were found in cognitive and affective risk perception between the intervention and control group and risk perception was on average low, even among high-risk participants.","[{'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Stol', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands. d.m.stol@umcutrecht.nl.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hollander', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'O C', 'Initials': 'OC', 'LastName': 'Damman', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam, the Netherlands.'}, {'ForeName': 'M M J', 'Initials': 'MMJ', 'LastName': 'Nielen', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), Utrecht, the Netherlands.'}, {'ForeName': 'I F', 'Initials': 'IF', 'LastName': 'Badenbroek', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Schellevis', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), Utrecht, the Netherlands.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'de Wit', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands.'}]",BMC public health,['10.1186/s12889-020-08906-z']
2747,32434813,"Correction:  Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W) .",,2020,,['patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W) '],['ixekizumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}]",[],,0.135237,,[],Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216118corr1']
2748,32434978,Clinical Performance of Short-fiber-reinforced Resin Composite Restorations vs Resin Composite Onlay Restorations in Complex Cavities of Molars (Randomized Clinical Trial).,"BACKGROUND


Short-fiber-reinforced resin composite (SFRC) is a direct bulk fill resin composite specially indicated in large complex cavities. It is characterized by having high fracture toughness and load bearing capacity to decrease the incidence of fracture of the restoration.
MATERIALS AND METHODS


In two parallel groups ( n  = 38 restorations), 76 participants having complex proximal cavities with asymptomatic vital pulp were randomly enrolled in this trial and received either SFRC (Ever X Posterior, GC, Japan) covered by Gaenial posterior (GC, Japan) or chairside indirect restorations (Grandioso inlay system; VOCO, Germany) fabricated on a silicon die. Materials were applied according to the manufacturer instructions with the corresponding adhesive system. Only 67 participants completed the trial, which was assessed using the modified United States Public Health Service (USPHS) criteria by two independent blinded assessors at 6 months and 1 year follow-up visits.
STATISTICAL ANALYSIS


Fisher's exact and Cochran's  Q  tests were used to analyze inter- and intragroup comparisons, respectively. The significance level was set at  p  ≤ 0.05.
RESULTS


No statistically significant difference was observed between both tested groups for all USPHS criteria at different follow-up periods except for marginal integrity favoring the SFRC at 12 months when the difference became significant ( p  < 0.001), and color match favoring the nanohybrid indirect resin composite restorations with significant difference in scores at all follow-up intervals ( p  < 0.001) was found. Cochran's  Q  test showed significant differences within the same technique during the follow-up period for some criteria.
CONCLUSION


Direct SFRC and indirect nanohybrid resin composite complex proximal restorations showed an acceptable clinical performance along the 1 year follow-up period.
CLINICAL RELEVANCE


Direct SFRC restorations could be a viable treatment option for complex restorative cases.",2020,"Direct SFRC and indirect nanohybrid resin composite complex proximal restorations showed an acceptable clinical performance along the 1 year follow-up period.
","['76 participants having complex proximal cavities with asymptomatic vital pulp', '67 participants completed the trial, which was assessed using the modified United States Public Health Service (USPHS) criteria by two independent blinded assessors at 6 months and 1 year follow-up visits']","['Short-fiber-reinforced resin composite (SFRC', 'SFRC (Ever X Posterior, GC, Japan) covered by Gaenial posterior (GC, Japan) or chairside indirect restorations (Grandioso inlay system; VOCO, Germany) fabricated on a silicon die', 'Short-fiber-reinforced Resin Composite Restorations vs Resin Composite Onlay Restorations']",['marginal integrity favoring the SFRC'],"[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041734', 'cui_str': 'United States. Public Health Service'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0444744', 'cui_str': 'Chairside'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0037107', 'cui_str': 'Silicon'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}]",,0.0691923,"Direct SFRC and indirect nanohybrid resin composite complex proximal restorations showed an acceptable clinical performance along the 1 year follow-up period.
","[{'ForeName': 'Rawda H', 'Initials': 'RH', 'LastName': 'ElAziz', 'Affiliation': 'Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Cairo, Egypt, Phone: +20 (002)01001097200, e-mail: rawda.hesham@dentistry.cu.edu.eg.'}, {'ForeName': 'Mai M', 'Initials': 'MM', 'LastName': 'Mohammed', 'Affiliation': 'Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hussien Af', 'Initials': 'HA', 'LastName': 'Gomaa', 'Affiliation': 'Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}]",The journal of contemporary dental practice,[]
2749,32429481,Iron Status of Burkinabé Adolescent Girls Predicts Malaria Risk in the Following Rainy Season.,"High levels of storage iron may increase malaria susceptibility. This risk has not been investigated in semi-immune adolescents. We investigated whether baseline iron status of non-pregnant adolescent girls living in a high malaria transmission area in Burkina Faso affected malaria risk during the following rainy season. For this prospective study, we analysed data from an interim safety survey, conducted six months into a randomised iron supplementation trial. We used logistic regression to model the risk of  P. falciparum  infection prevalence by microscopy, the pre-specified interim safety outcome, in relation to iron status, nutritional indicators and menarche assessed at recruitment. The interim survey was attended by 1223 (82%) of 1486 eligible participants, 1084 (89%) of whom were <20 years at baseline and 242 (22%) were pre-menarcheal. At baseline, prevalence of low body iron stores was 10%. At follow-up, 38% of adolescents had predominantly asymptomatic malaria parasitaemias, with no difference by menarcheal status. Higher body iron stores at baseline predicted an increased malaria risk in the following rainy season (OR 1.18 (95% CI 1.05, 1.34,  p  = 0.007) after adjusting for bed net use, age, menarche, and body mass index. We conclude that routine iron supplementation should not be recommended without prior effective malaria control.",2020,"At follow-up, 38% of adolescents had predominantly asymptomatic malaria parasitaemias, with no difference by menarcheal status.","['The interim survey was attended by 1223 (82%) of 1486 eligible participants, 1084 (89%) of whom were <20 years at baseline and 242 (22%) were pre-menarcheal', 'non-pregnant adolescent girls living in a high malaria transmission area in Burkina Faso affected malaria risk during the following rainy season']",['routine iron supplementation'],"['asymptomatic malaria parasitaemias', 'prevalence of low body iron stores', 'Higher body iron stores', 'malaria risk', 'Malaria Risk']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1486.0,0.150127,"At follow-up, 38% of adolescents had predominantly asymptomatic malaria parasitaemias, with no difference by menarcheal status.","[{'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Brabin', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, University of Manchester, Oxford Road, Manchester M13 9PL, UK.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Roberts', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, University of Manchester, Oxford Road, Manchester M13 9PL, UK.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Clinical Research Unit of Nanoro, (IRSS-URCN), B.P.218 Ouagadougou 11, Burkina Faso.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Gies', 'Affiliation': 'Department of Biomedical Sciences, Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium and Medical Mission Institute, 97074 Würzburg, Germany.'}, {'ForeName': 'Salou', 'Initials': 'S', 'LastName': 'Diallo', 'Affiliation': 'Clinical Research Unit of Nanoro, (IRSS-URCN), B.P.218 Ouagadougou 11, Burkina Faso.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Brabin', 'Affiliation': 'Liverpool School of Tropical Medicine and Institute of Infection and Global Health, University of Liverpool, Liverpool, UK.'}]",Nutrients,['10.3390/nu12051446']
2750,32429737,Effects of Montmorency Tart Cherry Juice Consumption on Cardiometabolic Biomarkers in Adults with Metabolic Syndrome: A Randomized Controlled Pilot Trial.,"Greater than one-third of adults in the United States have metabolic syndrome (MetS), a cluster of risk factors highly associated with the development of cardiovascular diseases. Premature vascular dysfunction in MetS may lead to accelerated age-related atherogenesis and arterial stiffening, thereby increasing cardiovascular risk. Montmorency tart cherries ( Prunus cerasus  L.) are rich in bioactive compounds, such as anthocyanins, known to exert cardiovascular protective effects. Previous research suggests that tart cherry juice consumption may improve cardiovascular health. The objective of this study was to evaluate the effects of daily consumption of tart cherry juice on hemodynamics, arterial stiffness, and blood biomarkers of cardiovascular and metabolic health in men and women with MetS. In a randomized, single-blind, placebo-controlled, parallel-arm pilot clinical trial, 19 men and women 20 to 60 years of age with MetS consumed 240 mL of tart cherry juice (Tart Cherry;  n  = 5 males, 4 females) or an isocaloric placebo-control drink (Control;  n  = 5 males, 5 females) twice daily for 12 weeks. Arterial stiffness (pulse wave velocity), brachial and aortic blood pressures, wave reflection (augmentation index), and blood biomarkers of cardiovascular and metabolic health were assessed at baseline and 6 and 12 weeks. Oxidized low-density lipoprotein and soluble vascular cell adhesion molecule-1 were significantly lower ( P  = .047 and  P  = .036, respectively) in Tart Cherry than Control at 12 weeks, but were not significantly lower than baseline values. There was a trend for total cholesterol to be lower ( P  = .08) in Tart Cherry than Control at 12 weeks. No significant changes were observed in hemodynamics, arterial stiffness, or other blood biomarkers assessed. These results suggest that daily tart cherry consumption may attenuate processes involved in accelerated atherogenesis without affecting hemodynamics or arterial stiffness parameters in this population. The pilot nature of this study warrants interpreting these findings with caution, and future clinical trials with a larger sample size are needed to confirm these findings.",2020,"Oxidized low-density lipoprotein and soluble vascular cell adhesion molecule-1 were significantly lower ( P  = .047 and  P  = .036, respectively) in Tart Cherry than Control at 12 weeks, but were not significantly lower than baseline values.","['men and women with MetS', 'Adults with Metabolic Syndrome', '19 men and women 20 to 60 years of age with MetS consumed 240\u2009mL of tart cherry juice (Tart Cherry;  n \u2009=\u20095 males, 4 females) or an']","['isocaloric placebo-control drink (Control;  n \u2009=\u20095 males, 5 females) twice daily for 12 weeks', 'Montmorency Tart Cherry Juice Consumption', 'daily consumption of tart cherry juice', 'placebo']","['Oxidized low-density lipoprotein and soluble vascular cell adhesion molecule-1', 'hemodynamics, arterial stiffness, or other blood biomarkers assessed', 'cardiovascular health', 'total cholesterol', 'hemodynamics, arterial stiffness, and blood biomarkers of cardiovascular and metabolic health', 'Arterial stiffness (pulse wave velocity), brachial and aortic blood pressures, wave reflection (augmentation index), and blood biomarkers of cardiovascular and metabolic health', 'Cardiometabolic Biomarkers']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0982074', 'cui_str': 'CHERRY JUICE'}, {'cui': 'C0330657', 'cui_str': 'Prunus cerasus'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0982074', 'cui_str': 'CHERRY JUICE'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0456180', 'cui_str': 'Aortic pressure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",19.0,0.103495,"Oxidized low-density lipoprotein and soluble vascular cell adhesion molecule-1 were significantly lower ( P  = .047 and  P  = .036, respectively) in Tart Cherry than Control at 12 weeks, but were not significantly lower than baseline values.","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Johnson', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Navaei', 'Affiliation': 'Department of Nutrition, Food, and Exercise Sciences, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Pourafshar', 'Affiliation': 'Department of Nutrition, Food, and Exercise Sciences, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'Salvador J', 'Initials': 'SJ', 'LastName': 'Jaime', 'Affiliation': 'Department of Nutrition, Food, and Exercise Sciences, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'Neda S', 'Initials': 'NS', 'LastName': 'Akhavan', 'Affiliation': 'Department of Nutrition, Food, and Exercise Sciences, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Alvarez-Alvarado', 'Affiliation': 'Department of Nutrition, Food, and Exercise Sciences, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'Gabriela V', 'Initials': 'GV', 'LastName': 'Proaño', 'Affiliation': 'Department of Nutrition, Food, and Exercise Sciences, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'Litwin', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Clark', 'Affiliation': 'Department of Nutrition, Food, and Exercise Sciences, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Foley', 'Affiliation': 'Department of Nutrition, Food, and Exercise Sciences, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'Kelli S', 'Initials': 'KS', 'LastName': 'George', 'Affiliation': 'Department of Nutrition, Food, and Exercise Sciences, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'Marcus L', 'Initials': 'ML', 'LastName': 'Elam', 'Affiliation': 'Department of Human Nutrition and Food Science, California State Polytechnic University, Pomona, California, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Payton', 'Affiliation': 'Department of Statistics, Oklahoma State University, Stillwater, Oklahoma, USA.'}, {'ForeName': 'Bahram H', 'Initials': 'BH', 'LastName': 'Arjmandi', 'Affiliation': 'Department of Nutrition, Food, and Exercise Sciences, Florida State University, Tallahassee, Florida, USA.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Figueroa', 'Affiliation': 'Department of Nutrition, Food, and Exercise Sciences, Florida State University, Tallahassee, Florida, USA.'}]",Journal of medicinal food,['10.1089/jmf.2019.0240']
2751,31834099,"No Influence of Low-, Medium-, or High-Dose Tyrosine on Exercise in a Warm Environment.","PURPOSE


Tyrosine administration may counter exercise fatigue in a warm environment, but the typical dose is inconclusive, with little known about higher doses. We explored how three tyrosine doses influenced the circulating ratio of tyrosine/amino acids competing for brain uptake and hypothesized that a medium and high dose would enhance exercise performance in a warm environment.
METHODS


Eight recreationally trained, non-heat-acclimated male individuals (mean ± SD age, 23 ± 4 yr; stature, 181 ± 7 cm; body mass, 76.1 ± 5.9 kg; peak oxygen uptake, 4.1 ± 0.5 L·min) performed a peak oxygen uptake test, two familiarization trials, then four experimental trials in a randomized order separated by 7 d. Before exercise, subjects drank 2 × 300 mL sugar-free drinks delivering 0 (PLA), 150 (LOW), 300 (MED), or 400 (HIGH) mg·kg body mass tyrosine in a double-blind fashion. Subjects performed a 60-min constant intensity cycling then a simulated time trial in 30°C and 60% relative humidity.
RESULTS


Time trial performance (P = 0.579) was not influenced by tyrosine ingestion. The plasma ratio of tyrosine/∑(free-tryptophan, leucine, isoleucine, valine, phenylalanine, methionine), a key determinant of brain tyrosine influx, increased relative to PLA (P < 0.001). The increase was similar (P > 0.05) in MED (7.7-fold) and HIGH (8.2-fold), and greater than that in LOW (5.3-fold; P < 0.05). No differences existed between trials in core and skin temperature, heart rate, RPE, or thermal sensation (P > 0.05).
CONCLUSION


Exercise performance in a warm environment was not influenced by tyrosine availability in recreationally trained male individuals. The results provide novel data informing future studies, on the tyrosine dose maximizing the circulating ratio of tyrosine/amino acids competing for brain uptake.",2020,"No differences existed between trials in core and skin temperature, heart rate, RPE, or thermal sensation (P > 0.05).
","['recreationally trained male individuals', 'Eight recreationally trained, non-heat-acclimated male individuals (mean ± SD age, 23 ± 4 yr; stature, 181 ± 7 cm; body mass, 76.1 ± 5.9 kg; peak oxygen uptake, 4.1 ± 0.5 L·min) performed a peak oxygen uptake test, two familiarization trials']","['Low-, Medium-, or High-Dose Tyrosine', 'subjects drank 2 × 300 mL sugar-free drinks delivering 0 (PLA), 150 (LOW), 300 (MED), or 400 (HIGH) mg·kg body mass tyrosine in a double-blind fashion']","['core and skin temperature, heart rate, RPE, or thermal sensation', 'plasma ratio of tyrosine/∑(free-tryptophan, leucine, isoleucine, valine, phenylalanine, methionine), a key determinant of brain tyrosine influx']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0022192', 'cui_str': 'Isoleucine'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}]",8.0,0.149914,"No differences existed between trials in core and skin temperature, heart rate, RPE, or thermal sensation (P > 0.05).
","[{'ForeName': 'Les', 'Initials': 'L', 'LastName': 'Tumilty', 'Affiliation': 'Institute of Biological, Environmental and Rural Sciences, Aberystwyth University, Wales, UNITED KINGDOM.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Gregory', 'Affiliation': ''}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Beckmann', 'Affiliation': ''}, {'ForeName': 'Rhys', 'Initials': 'R', 'LastName': 'Thatcher', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002245']
2752,32434362,The clinical effect of plum blossom needle acupuncture with qi-invigorating superficies-consolidating therapy on seborrheic alopecia.,"BACKGROUND


Seborrheic alopecia (SA) is a common dermatological disease with a long disease course, and treatment for this disease usually exhibits slow effects. Currently, Western medicine treatments have shown some effects; however, they also have certain limitations. In recent years, Chinese medicine has made breakthroughs in treating SA. The efficacy of plum blossom needle acupuncture with qi-invigorating superficies-consolidating therapy for SA was observed, and its clinical effects were investigated in this study.
METHODS


A total of 87 patients with SA treated at the First Affiliated Hospital of Guangzhou University of Chinese Medicine from September 2018 to September 2019 were enrolled as the research subjects. They were divided into a Western medicine group and a Chinese medicine group by the random number table method. The 43 patients in the Western medicine group were treated with conventional Western medicine, and the 44 patients in the Chinese medicine group were treated with a comprehensive traditional Chinese medicine regimen of plum blossom needling with qi-invigorating superficies-consolidating therapy. The treatment effects, changes in estradiol (E2) and testosterone (T) levels, and scores for various body signs (hair growth and hair loss) of the two groups before and after treatment were compared.
RESULTS


The difference in total effective rate between the Chinese medicine group and the Western medicine group (95.45% vs. 81.40%) was statistically significant (P<0.05). After treatment, the T levels of both groups were lower than before treatment, and the E2 levels of both groups were higher than before treatment; the difference between the two groups was statistically significant (P<0.05). After treatment, the hair growth and hair loss scores of the two groups were lower than those before treatment, and those of the Chinese medicine group were lower than those of the Western medicine group; the differences were statistically significant (P<0.05).
CONCLUSIONS


Plum blossom needle acupuncture combined with qi-invigorating superficies-consolidating therapy is significantly effective for treating patients with SA. It can effectively adjust the patient's hormone levels, improve hair loss, and promote hair growth. It has the advantages of simplicity, tolerability, and low cost. It cures the cause of the disease and is worth promoting.",2020,"After treatment, the T levels of both groups were lower than before treatment, and the E2 levels of both groups were higher than before treatment; the difference between the two groups was statistically significant (P<0.05).","['87 patients with SA treated at the First Affiliated Hospital of Guangzhou University of Chinese Medicine from September 2018 to September 2019 were enrolled as the research subjects', 'patients with SA', '43 patients in the Western medicine group were treated with']","['conventional Western medicine', 'plum blossom needle acupuncture with qi-invigorating superficies-consolidating therapy', 'Chinese medicine', 'comprehensive traditional Chinese medicine regimen of plum blossom needling with qi-invigorating superficies-consolidating therapy']","['hair growth and hair loss scores', 'total effective rate', 'seborrheic alopecia', 'changes in estradiol (E2) and testosterone (T) levels, and scores for various body signs (hair growth and hair loss', 'E2 levels', 'T levels', 'hair loss, and promote hair growth']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0330660', 'cui_str': 'Prunus domestica'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0181956', 'cui_str': 'Acupuncture needle'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0232407', 'cui_str': 'Hair growth'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",87.0,0.0221398,"After treatment, the T levels of both groups were lower than before treatment, and the E2 levels of both groups were higher than before treatment; the difference between the two groups was statistically significant (P<0.05).","[{'ForeName': 'Qiuyi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.'}, {'ForeName': 'Yubin', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.'}, {'ForeName': 'Xushan', 'Initials': 'X', 'LastName': 'Zha', 'Affiliation': 'Department of Dermatology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China. lmmengmeng@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-909']
2753,32434454,The fourier M2 robotic machine combined with occupational therapy on post-stroke upper limb function and independence-related quality of life: A randomized clinical trial.,"Most post-stroke patients experience upper limb functionality challenges. Emergent therapies using upper limb-based robot machines present opportunities to resolve the limitations inherent in Occupational therapy such as increased therapist-patient exhaustion, monotonous methods, and so forth. The aim of this parallel trial was to compare the effects of the upper limb robotic training with matched Occupational therapy training on upper limb function and independence-related quality of life in post-stroke patients within the Brunnstrom arm motor recovery stages 1 to 4. During one-year (2018-2019), 50 post-stroke patients were enrolled and randomly assigned to 2 groups; robot and Occupational therapy (n = 25) and Occupational therapy (n = 25). Both groups were trained for 50-70 minutes per day, 5 days a week for 6 weeks. The Chinese-adapted Fugl-Meyer Assessment-Upper Extremity (FMA-UE) was the primary outcome measure. The secondary outcome measures were the Brunnstrom Recovery Stages Scale (BRS) and the Chinese-adapted Barthel Index (BI). The treatment effect sizes of both groups were large in the following variables; transfers (1), BI total score (2.2), FMA-UE upper limb (1.1), wrist (1.8), elbow (1), fingers (0.9), and FMA-UE total scores (1.4). The treatment group in comparison to the control group had larger BRS changes, significant improvements in upper limb function, and partial independence in activities of daily living during the baseline to post-treatment period. Robotic-assisted training with occupational therapy may improve the upper limb movement foundation blocks; however, it does not translate into complete functional independence and improved quality of life. This study has been registered at the ISRCTN registry, https://doi.org/10.1186/ISRCTN84804731.",2020,"The treatment group in comparison to the control group had larger BRS changes, significant improvements in upper limb function, and partial independence in activities of daily living during the baseline to post-treatment period.","['post-stroke patients within the Brunnstrom arm motor recovery stages 1 to 4', 'During one-year (2018-2019), 50 post-stroke patients']","['upper limb robotic training with matched Occupational therapy training', 'robot and Occupational therapy (n\xa0=\xa025) and Occupational therapy', 'Robotic-assisted training with \ufeffoccupational therapy', 'fourier M2 robotic machine combined with occupational therapy']","['Brunnstrom Recovery Stages Scale (BRS) and the Chinese-adapted Barthel Index (BI', 'quality of life', 'larger BRS changes', 'post-stroke upper limb function and independence-related quality of life', 'upper limb function and independence-related quality of life', 'BI total score (2.2), FMA-UE upper limb (1.1), wrist (1.8), elbow (1), fingers (0.9), and FMA-UE total scores', 'upper limb function, and partial independence in activities of daily living']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.0537668,"The treatment group in comparison to the control group had larger BRS changes, significant improvements in upper limb function, and partial independence in activities of daily living during the baseline to post-treatment period.","[{'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Chinembiri', 'Affiliation': ""Department of Rehabilitation Medicine, Xuzhou Medical University, School of International Education , Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Ming', 'Affiliation': ""Department of Occupational Therapy, The Affiliated Xuzhou Rehabilitation Hospital of Xuzhou Medical University , Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Shang', 'Initials': 'S', 'LastName': 'Kai', 'Affiliation': ""Department of Occupational Therapy, The Affiliated Xuzhou Rehabilitation Hospital of Xuzhou Medical University , Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Xiu Fang', 'Affiliation': ""Department of Occupational Therapy, The Affiliated Xuzhou Rehabilitation Hospital of Xuzhou Medical University , Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': ""Department of Rehabilitation Medicine, Xuzhou Medical University, School of International Education , Xuzhou, Jiangsu, People's Republic of China.""}]",Topics in stroke rehabilitation,['10.1080/10749357.2020.1755815']
2754,32434467,Practice facilitation to promote evidence-based screening and management of unhealthy alcohol use in primary care: a practice-level randomized controlled trial.,"BACKGROUND


Unhealthy alcohol use is the third leading cause of preventable death in the United States. Evidence demonstrates that screening for unhealthy alcohol use and providing persons engaged in risky drinking with brief behavioral and counseling interventions improves health outcomes, collectively termed screening and brief interventions. Medication assisted therapy (MAT) is another effective method for treatment of moderate or severe alcohol use disorder. Yet, primary care clinicians are not regularly screening for or treating unhealthy alcohol use.
METHODS AND ANALYSIS


We are initiating a clinic-level randomized controlled trial aimed to evaluate how primary care clinicians can impact unhealthy alcohol use through screening, counseling, and MAT. One hundred and 25 primary care practices in the Virginia Ambulatory Care Outcomes Research Network (ACORN) will be engaged; each will receive practice facilitation to promote screening, counseling, and MAT either at the beginning of the trial or at a 6-month control period start date. For each practice, the intervention includes provision of a practice facilitator, learning collaboratives with three practice champions, and clinic-wide information sessions. Clinics will be enrolled for 6-12 months. After completion of the intervention, we will conduct a mixed methods analysis to identify changes in screening rates, increase in provision of brief counseling and interventions as well as MAT, and the reduction of alcohol intake for patients after practices receive practice facilitation.
DISCUSSION


This study offers a systematic process for dissemination and implementation of the evidence-based practice of screening, counseling, and treatment for unhealthy alcohol use. Practices will be asked to implement a process for screening, counseling, and treatment based on their practice characteristics, patient population, and workflow. We propose practice facilitation as a robust and feasible intervention to assist in making changes within the practice. We believe that the process can be replicated and used in a broad range of clinical settings; we anticipate this will be supported by our evaluation of this approach.
TRIAL REGISTRATION


ClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT04248023, Registered 5 February 2020.",2020,"This study offers a systematic process for dissemination and implementation of the evidence-based practice of screening, counseling, and treatment for unhealthy alcohol use.",['One hundred and 25 primary care practices in the Virginia Ambulatory Care Outcomes Research Network (ACORN) will be engaged'],['Medication assisted therapy (MAT'],['health outcomes'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0890021,"This study offers a systematic process for dissemination and implementation of the evidence-based practice of screening, counseling, and treatment for unhealthy alcohol use.","[{'ForeName': 'Alison N', 'Initials': 'AN', 'LastName': 'Huffstetler', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA. Alison.huffstetler@vcuhealth.org.'}, {'ForeName': 'Anton J', 'Initials': 'AJ', 'LastName': 'Kuzel', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}, {'ForeName': 'Roy T', 'Initials': 'RT', 'LastName': 'Sabo', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Richards', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'E Marshall', 'Initials': 'EM', 'LastName': 'Brooks', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Lail Kashiri', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Villalobos', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Arias', 'Affiliation': 'Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Dace', 'Initials': 'D', 'LastName': 'Svikis', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Bortz', 'Affiliation': 'Virginia Center for Health Innovation, Henrico, VA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Virginia Center for Health Innovation, Henrico, VA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Epling', 'Affiliation': 'Department of Family and Community Medicine, Virginia Tech Carilion School of Medicine, Roanoke, VA, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'Department of Family Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Parchman', 'Affiliation': 'MacColl Center, Kaiser Permanente of Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Winter', 'Affiliation': 'Shenandoah Valley Family Practice Residency, Virginia Commonwealth University, Front Royal, VA, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Wessler', 'Affiliation': 'Riverside Family Medicine Residency, Virginia Commonwealth University, Newport News, VA, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Yu', 'Affiliation': 'St. Francis Family Medicine Residency, Virginia Commonwealth University, Midlothian, VA, USA.'}, {'ForeName': 'Alex H', 'Initials': 'AH', 'LastName': 'Krist', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}]",BMC family practice,['10.1186/s12875-020-01147-4']
2755,32434470,"GlideScope® versus C-MAC®(D) videolaryngoscope versus Macintosh laryngoscope for double lumen endotracheal intubation in patients with predicted normal airways: a randomized, controlled, prospective trial.","BACKGROUND


The double lumen endotracheal tube (DLT) is the most widely-used device for single lung ventilation in current thoracic anesthesia practice. In recent years, the routine application of the videolaryngoscope for single lumen endotracheal intubation has increased; nevertheless there are few studies of the use of the videolaryngoscope for DLT. We wondered whether there were benefits to using the videolaryngoscope for DLT placement in patients with predicted normal airways. Therefore, this study was designed to compare the performances of the GlideScope®, the C-MAC®(D) videolaryngoscope and the Macintosh laryngoscope in DLT intubation.
METHODS


This was a randomized, controlled, prospective study. We randomly allocated 90 adult patients with predicted normal airways into three groups. All patients underwent routine anesthesia using different laryngoscopes according to group allocation. We compared DLT insertion times, first-pass success rates, numerical rating scales (NRS) of DLT delivery and DLT insertion, Cormack-Lehane degrees (C/L), hemodynamic changes and incidences of intubation complications. All outcomes were analyzed using SPSS13.0.
RESULTS


Compared with the GlideScope, the Macintosh gave shorter times for DLT insertion (median: 96 (IQR: 51 [min-max: 62-376] s vs 73 (26 [48-419] s, p = 0.003); however, there was no difference between the Macintosh and C-MAC(D) (p = 0.610). The Macintosh had a significantly higher successful first attempt rate than did the GlideScope or C-MAC(D) (p = 0.001, p = 0.028, respectively). NRS of DLT delivery and insertion were significantly lower in the Macintosh than in the others (p < 0.001). However, the C/L degree in the Macintosh was significantly higher than in the others (p < 0.001). The incidences of oral bleeding, hoarseness, sore throat and dental trauma were low in all groups (p > 0.05). There were no significant differences in DLT misplacement, fiberoptic time or hemodynamic changes among the groups.
CONCLUSIONS


Compared with the Macintosh laryngoscope, the GlideScope® and C-MAC®(D) videolaryngoscopes may not be recommended as the first choice for routine DLT intubation in patients with predicted normal airways.
TRIAL REGISTRATION


The study was prospectively registered at the Chinese Clinical Trial Registry (no. ChiCTR1900025718); principal investigator: Z.L.H.; date of registration: September 6, 2019.",2020,The Macintosh had a significantly higher successful first attempt rate than did the GlideScope or C-MAC(D),"['90 adult patients with predicted normal airways into three groups', 'patients with predicted normal airways']","['C-MAC®(D', 'routine anesthesia', 'GlideScope® versus C-MAC®(D) videolaryngoscope versus Macintosh laryngoscope', 'double lumen endotracheal tube (DLT']","['incidences of oral bleeding, hoarseness, sore throat and dental trauma', 'DLT misplacement, fiberoptic time or hemodynamic changes', 'DLT insertion times, first-pass success rates, numerical rating scales (NRS) of DLT delivery and DLT insertion, Cormack-Lehane degrees (C/L), hemodynamic changes and incidences of intubation complications', 'NRS of DLT delivery and insertion', 'successful first attempt rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0029163', 'cui_str': 'Bleeding from mouth'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C1301685', 'cui_str': 'Dental trauma'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1504364', 'cui_str': 'Intubation complication'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",90.0,0.0618911,The Macintosh had a significantly higher successful first attempt rate than did the GlideScope or C-MAC(D),"[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.'}, {'ForeName': 'Renlong', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.'}, {'ForeName': 'Zhixing', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Hang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.'}, {'ForeName': 'Shanjuan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China. Shanjuanwang@shsmu.edu.cn.'}, {'ForeName': 'Zhenling', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China. Zhenlinghuang@shsmu.edu.cn.'}]",BMC anesthesiology,['10.1186/s12871-020-01012-y']
2756,32434638,[Sedative effect of intranasal midazolam in neonates undergoing magnetic resonance imaging: a prospective single-blind randomized controlled study].,"OBJECTIVE


To compare intranasal midazolam and intramuscular phenobarbital sodium for their sedative effect in neonates undergoing magnetic resonance imaging (MRI).
METHODS


A total of 70 neonates who underwent cranial MRI from September 2017 to March 2019 were randomized into an observation group and a control group, with 35 cases in each group. The observation group received intranasal drops of midazolam (0.3 mg/kg), and the control group received intramuscular injection of phenobarbital sodium (10 mg/kg). The sedation status of the neonates was evaluated using the Ramsay Sedation Scale. Meanwhile, the two groups were compared for the success rate of MRI procedure and incidence of adverse reactions.
RESULTS


In the observation group, the sedation score was the highest at 20 minutes post administration, then was gradually decreasing, and decreased to the lowest level at 70 minutes post administration. In the control group, the sedation score was the lowest at 10 minutes post administration, then was gradually increasing, and increased to the highest level at 40 minutes and 50 minutes post administration, followed by a gradual decrease. Comparison of the sedation score at each time period suggested that the sedation score was significantly higher in the observation group than in the control group within 40 minutes post administration (P<0.05), while there were no significant differences between the two groups in the sedation score after 40 minutes post administration (P>0.05). The success rate of MRI procedure was significantly higher in the observation group than in the control group (89% vs 69%, P<0.05). There was no significant difference between the two groups in the incidence of adverse reactions (P>0.05).
CONCLUSIONS


Intranasal midazolam is superior to intramuscular phenobarbital sodium in the sedative effect in neonates undergoing MRI, with the benefits of being fast, convenient, safe, and effective.",2020,"There was no significant difference between the two groups in the incidence of adverse reactions (P>0.05).
","['70 neonates who underwent cranial MRI from September 2017 to March 2019', 'neonates undergoing magnetic resonance imaging (MRI', 'neonates undergoing MRI', 'neonates undergoing magnetic resonance imaging']","['intramuscular injection of phenobarbital sodium', 'intranasal drops of midazolam', 'intranasal midazolam', 'midazolam and intramuscular phenobarbital sodium', 'midazolam']","['success rate of MRI procedure and incidence of adverse reactions', 'incidence of adverse reactions', 'sedation score', 'Ramsay Sedation Scale', 'success rate of MRI procedure']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0282303', 'cui_str': 'Phenobarbital sodium'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}]",70.0,0.0813785,"There was no significant difference between the two groups in the incidence of adverse reactions (P>0.05).
","[{'ForeName': 'Fang-Hui', 'Initials': 'FH', 'LastName': 'Wang', 'Affiliation': ""Department of Neonatology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China. zhouxih@mail.xjtu.edu.cn.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Xi-Hui', 'Initials': 'XH', 'LastName': 'Zhou', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
2757,32434847,"A double-blind, placebo-controlled phase 1/2a trial of the genetically attenuated malaria vaccine PfSPZ-GA1.","Immunization with attenuated  Plasmodium  sporozoites can induce protection against malaria infection, as shown by  Plasmodium falciparum  (Pf) sporozoites attenuated by radiation in multiple clinical trials. As alternative attenuation strategy with a more homogeneous population of Pf sporozoites (PfSPZ), genetically engineered  Plasmodium berghei  sporozoites (SPZ) lacking the genes b9 and slarp induced sterile protection against malaria in mice. Consequently, PfSPZ-GA1 Vaccine, a Pf identical double knockout (Pf∆ b9 ∆ slarp ), was generated as a genetically attenuated malaria parasite vaccine and tested for safety, immunogenicity, and preliminary efficacy in malaria-naïve Dutch volunteers. Dose-escalation immunizations up to 9.0 × 10 5  PfSPZ of PfSPZ-GA1 Vaccine were well tolerated without breakthrough blood-stage infection. Subsequently, groups of volunteers were immunized three times by direct venous inoculation with cryopreserved PfSPZ-GA1 Vaccine (9.0 × 10 5  or 4.5 × 10 5  PfSPZ,  N  = 13 each), PfSPZ Vaccine (radiation-attenuated PfSPZ, 4.5 × 10 5  PfSPZ,  N  = 13), or normal saline placebo at 8-week intervals, followed by exposure to mosquito bite controlled human malaria infection (CHMI). After CHMI, 3 of 25 volunteers from both PfSPZ-GA1 groups were sterilely protected, and the remaining 17 of 22 showed a patency ≥9 days (median patency in controls, 7 days; range, 7 to 9). All volunteers in the PfSPZ Vaccine control group developed parasitemia (median patency, 9 days; range, 7 to 12). Immunized groups exhibited a significant, dose-related increase in anti-Pf circumsporozoite protein (CSP) antibodies and Pf-specific interferon-γ (IFN-γ)-producing T cells. Although no definite conclusion can be drawn on the potential strength of protective efficacy of PfSPZ-GA1 Vaccine, the favorable safety profile and induced immune responses by PfSPZ-GA1 Vaccine warrant further clinical evaluation.",2020,"Immunized groups exhibited a significant, dose-related increase in anti-Pf circumsporozoite protein (CSP) antibodies and Pf-specific interferon-γ (IFN-γ)-producing T cells.",['malaria-naïve Dutch volunteers'],"['PfSPZ Vaccine control', 'PfSPZ-GA1 Vaccine', 'PfSPZ Vaccine (radiation-attenuated PfSPZ, 4.5 × 10 5  PfSPZ,  N  = 13), or normal saline placebo', 'cryopreserved PfSPZ-GA1 Vaccine', 'malaria vaccine PfSPZ-GA1', 'placebo']","['tolerated without breakthrough blood-stage infection', 'anti-Pf circumsporozoite protein (CSP) antibodies and Pf-specific interferon-γ (IFN-γ)-producing T cells', 'parasitemia']","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0268595', 'cui_str': 'Glutaric aciduria, type 1'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0206255', 'cui_str': 'Malarial Vaccines'}]","[{'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1445860', 'cui_str': 'Protein antibody'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}]",25.0,0.0746047,"Immunized groups exhibited a significant, dose-related increase in anti-Pf circumsporozoite protein (CSP) antibodies and Pf-specific interferon-γ (IFN-γ)-producing T cells.","[{'ForeName': 'Meta', 'Initials': 'M', 'LastName': 'Roestenberg', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.'}, {'ForeName': 'Jona', 'Initials': 'J', 'LastName': 'Walk', 'Affiliation': 'Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.'}, {'ForeName': 'Saskia C', 'Initials': 'SC', 'LastName': 'van der Boor', 'Affiliation': 'Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.'}, {'ForeName': 'Marijke C C', 'Initials': 'MCC', 'LastName': 'Langenberg', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.'}, {'ForeName': 'Marie-Astrid', 'Initials': 'MA', 'LastName': 'Hoogerwerf', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.'}, {'ForeName': 'Jacqueline J', 'Initials': 'JJ', 'LastName': 'Janse', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.'}, {'ForeName': 'Mikhael', 'Initials': 'M', 'LastName': 'Manurung', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.'}, {'ForeName': 'X Zen', 'Initials': 'XZ', 'LastName': 'Yap', 'Affiliation': 'Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.'}, {'ForeName': 'Amanda Fabra', 'Initials': 'AF', 'LastName': 'García', 'Affiliation': 'Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.'}, {'ForeName': 'Jan Pieter R', 'Initials': 'JPR', 'LastName': 'Koopman', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Meij', 'Affiliation': 'Interdivisional GMP Facility, Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Wessels', 'Affiliation': 'Department of Medical Microbiology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Teelen', 'Affiliation': 'Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.'}, {'ForeName': 'Youri M', 'Initials': 'YM', 'LastName': 'van Waardenburg', 'Affiliation': 'Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.'}, {'ForeName': 'Marga', 'Initials': 'M', 'LastName': 'van de Vegte-Bolmer', 'Affiliation': 'Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.'}, {'ForeName': 'Geert Jan', 'Initials': 'GJ', 'LastName': 'van Gemert', 'Affiliation': 'Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.'}, {'ForeName': 'Leo G', 'Initials': 'LG', 'LastName': 'Visser', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.'}, {'ForeName': 'André J A M', 'Initials': 'AJAM', 'LastName': 'van der Ven', 'Affiliation': 'Radboudumc Center for Infectious Diseases, Department of Internal Medicine, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.'}, {'ForeName': 'Quirijn', 'Initials': 'Q', 'LastName': 'de Mast', 'Affiliation': 'Radboudumc Center for Infectious Diseases, Department of Internal Medicine, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Natasha', 'Affiliation': 'Sanaria Inc., Rockville, MD 20850, USA.'}, {'ForeName': 'Yonas', 'Initials': 'Y', 'LastName': 'Abebe', 'Affiliation': 'Sanaria Inc., Rockville, MD 20850, USA.'}, {'ForeName': 'Tooba', 'Initials': 'T', 'LastName': 'Murshedkar', 'Affiliation': 'Sanaria Inc., Rockville, MD 20850, USA.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Billingsley', 'Affiliation': 'Sanaria Inc., Rockville, MD 20850, USA.'}, {'ForeName': 'Tom L', 'Initials': 'TL', 'LastName': 'Richie', 'Affiliation': 'Sanaria Inc., Rockville, MD 20850, USA.'}, {'ForeName': 'B Kim Lee', 'Initials': 'BKL', 'LastName': 'Sim', 'Affiliation': 'Sanaria Inc., Rockville, MD 20850, USA.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Janse', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria Inc., Rockville, MD 20850, USA.'}, {'ForeName': 'Shahid M', 'Initials': 'SM', 'LastName': 'Khan', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Sauerwein', 'Affiliation': 'Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands. robert.sauerwein@radboudumc.nl.'}]",Science translational medicine,['10.1126/scitranslmed.aaz5629']
2758,32429069,Effect of a Short Message Service Intervention on Excessive Gestational Weight Gain in a Low-Income Population: A Randomized Controlled Trial.,"OBJECTIVES


The objective of this trial was to investigate the effect of educational short message service (SMS), or text messages, on excessive gestational weight gain (GWG) in a low-income, predominantly overweight/obese population.
METHODS


Participants ( n  = 83) were mostly overweight/obese women recruited at Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) clinics on the island of O'ahu, Hawai'i at 15-20 weeks gestational age. The intervention group received SMS on nutrition and physical activity during pregnancy designed to help them meet Institute of Medicine (IOM) guidelines for GWG and American College of Obstetricians and Gynecologists guidelines for exercise, respectively. The control group received SMS about general health topics during pregnancy, excluding nutrition and physical activity. Both groups received one text message per week for eighteen weeks. GWG was defined as the difference between the last self-reported weight taken before delivery and participants' self-reported weight before pregnancy. Differences between study groups were examined using t-tests and Chi-square tests. Linear regression models were used to examine association of GWG with study group and other factors.
RESULTS


GWG was similar ( p  = 0.58) in the control group (14.1 ± 11.4 kg) and the intervention group (15.5 ± 11.6 kg). The percentage of participants exceeding IOM guidelines for GWG was similar ( p  = 0.51) in the control group (50.0%,  n  = 17) and the intervention group (60.5%,  n  = 23).
CONCLUSIONS


GWG was not significantly different between intervention and control groups. Trials that begin earlier in pregnancy or before pregnancy with longer intervention durations and varying message frequency as well as personalized or interactive messages may be needed to produce significant improvements.",2020,"The percentage of participants exceeding IOM guidelines for GWG was similar ( p  = 0.51) in the control group (50.0%,  n  = 17) and the intervention group (60.5%,  n  = 23).
","['Participants ( n  = 83) were mostly overweight/obese women recruited at', 'low-income, predominantly overweight/obese population', ""for Women, Infants, and Children (WIC) clinics on the island of O'ahu, Hawai'i at 15-20 weeks gestational age"", 'a Low-Income Population']","['SMS', 'Short Message Service Intervention', 'educational short message service (SMS), or text messages', 'SMS on nutrition and physical activity during pregnancy designed to help them meet Institute of Medicine (IOM) guidelines for GWG', 'Special Supplemental Nutrition Program']","['Excessive Gestational Weight Gain', 'excessive gestational weight gain (GWG']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0455000', 'cui_str': 'Oahu'}, {'cui': 'C0018619', 'cui_str': 'Hawaii state'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0024045', 'cui_str': 'Low Income Population'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",83.0,0.0572663,"The percentage of participants exceeding IOM guidelines for GWG was similar ( p  = 0.51) in the control group (50.0%,  n  = 17) and the intervention group (60.5%,  n  = 23).
","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Holmes', 'Affiliation': 'Department of Human Nutrition, Food and Animal Sciences, College of Tropical Agriculture and Human Resources, University of Hawaii at Manoa, Honolulu, HI 96822, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Department of Dietetics and Nutrition, Stempel College of Public Health and Social Work, Florida International University, Miami, FL 33199, USA.'}, {'ForeName': 'YanYan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Office of Public Health Studies, University of Hawaii at Manoa, Honolulu, HI 96822, USA.'}, {'ForeName': 'Jinan', 'Initials': 'J', 'LastName': 'Banna', 'Affiliation': 'Department of Human Nutrition, Food and Animal Sciences, College of Tropical Agriculture and Human Resources, University of Hawaii at Manoa, Honolulu, HI 96822, USA.'}]",Nutrients,['10.3390/nu12051428']
2759,32429406,Biomarkers of Muscle Metabolism in Peripheral Artery Disease: A Dynamic NIRS-Assisted Study to Detect Adaptations Following Revascularization and Exercise Training.,"We assessed whether muscle metabolism biomarkers (MMb) identified by near-infrared spectroscopy (NIRS) are valid for determining adaptations following revascularization or exercise training in peripheral artery disease (PAD). Eighteen patients (males  n  = 13; 69 ± 7 years) were randomized to receive revascularization (Rev = 6) or pain-free home-based exercise (Ex = 12). MMb were safely collected via a NIRS-assisted treadmill test as area-under-curve for the spectra of oxygenated (-oxy), deoxygenated (-deoxy), differential (-diff) and total (-tot) hemoglobin traces. MMb, ankle-brachial index (ABI), pain-free (PFWD) and 6-minute (6MWD) walking distances were assessed at baseline and after four months. MMb were correlated at baseline with ABI (MMb-oxy  r  = 0.46) and 6MWD (MMb-tot  r  = 0.51). After treatments, MMb-oxy showed an expected increase, which was more relevant for Rev group than the Ex (56% vs. 20%), with trends towards normalization for the other MMb. These changes were significantly correlated with variations in ABI (MMb-oxy  r  = 0.71;  p  = 0.002) and 6MWD (MMb-tot  r  = 0.58;  p  = 0.003). The MMb-diff in Rev group and MMb-deoxy in Ex group at baseline predicted clinical outcomes being correlated with PFWD improvements after 4-month ( r =-0.94;  p  = 0.005 and  r  = -0.57;  p  = 0.05, respectively). A noninvasive NIRS-based test, feasible in a clinical setting, identified muscle metabolism biomarkers in PAD. The novel MMb were associated with validated outcome measures, selectively modified after different interventions and able to predict long-term functional improvements after surgery or exercise training.",2020,"The novel MMb were associated with validated outcome measures, selectively modified after different interventions and able to predict long-term functional improvements after surgery or exercise training.","['Eighteen patients (males  n  = 13; 69 ± 7 years', 'Peripheral Artery Disease', 'peripheral artery disease (PAD']","['revascularization or exercise training', 'muscle metabolism biomarkers (MMb) identified by near-infrared spectroscopy (NIRS', 'revascularization (Rev = 6) or pain-free home-based exercise', 'Revascularization and Exercise Training']","['MMb', 'PFWD improvements', 'MMb, ankle-brachial index (ABI), pain-free (PFWD) and 6-minute (6MWD) walking distances']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.034182,"The novel MMb were associated with validated outcome measures, selectively modified after different interventions and able to predict long-term functional improvements after surgery or exercise training.","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Section of Sports Sciences, Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Italy-Via Luigi Borsari 46, 44121 Ferrara, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Section of Sports Sciences, Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Italy-Via Luigi Borsari 46, 44121 Ferrara, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ficarra', 'Affiliation': 'Unit of Vascular and Endovascular Surgery; University Hospital of Ferrara. Via Aldo Moro 8, 44124 Ferrara, Italy.'}, {'ForeName': 'Elpiniki', 'Initials': 'E', 'LastName': 'Tsolaki', 'Affiliation': 'Unit of Vascular and Endovascular Surgery; University Hospital of Ferrara. Via Aldo Moro 8, 44124 Ferrara, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Unit of Physical Medicine and Rehabilitation; Department of Neurosciences/Rehabilitation, University Hospital of Ferrara. Via Aldo Moro 8, 44124 Ferrara, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zamboni', 'Affiliation': 'Vascular Diseases Center, University of Ferrara, Italy-Via Aldo Moro 8, 44124 Ferrara, Italy.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Unit of Physical Medicine and Rehabilitation; Department of Neurosciences/Rehabilitation, University Hospital of Ferrara. Via Aldo Moro 8, 44124 Ferrara, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Gasbarro', 'Affiliation': 'Unit of Vascular and Endovascular Surgery; University Hospital of Ferrara. Via Aldo Moro 8, 44124 Ferrara, Italy.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10050312']
2760,32429429,Effect of Cod Residual Protein Supplementation on Markers of Glucose Regulation in Lean Adults: A Randomized Double-Blind Study.,"Large quantities of protein-rich cod residuals, which are currently discarded, could be utilized for human consumption. Although fish fillet intake is related to beneficial health effects, little is known about the potential health effects of consuming cod residual protein powder. Fifty lean adults were randomized to consume capsules with 8.1 g/day of cod residual protein (Cod-RP) or placebo capsules (Control group) for eight weeks, in this randomized, double-blind study. The intervention was completed by 40 participants. Fasting glucose and insulin concentrations were unaffected by Cod-RP supplementation, whereas plasma concentrations of α-hydroxybutyrate, β-hydroxybutyrate and acetoacetate all were decreased compared with the Control group. Trimethylamine N-oxide concentration in plasma and urine were increased in the Cod-RP group compared with the Control group. To conclude, the reduction in these potential early markers of impaired glucose metabolism following Cod-RP supplementation may indicate beneficial glucoregulatory effects of cod residual proteins. Trimethylamine N-oxide appears to be an appropriate biomarker of cod residual protein intake in lean adults.",2020,Trimethylamine N-oxide concentration in plasma and urine were increased in the Cod-RP group compared with the Control group.,"['Lean Adults', 'lean adults', 'Fifty lean adults']","['Cod Residual Protein Supplementation', 'consume capsules with 8.1 g/day of cod residual protein (Cod-RP) or placebo capsules (Control group', 'Cod-RP supplementation', 'Trimethylamine N-oxide']","['Trimethylamine N-oxide concentration in plasma and urine', 'Markers of Glucose Regulation', 'Fasting glucose and insulin concentrations', 'plasma concentrations of α-hydroxybutyrate, β-hydroxybutyrate and acetoacetate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}]","[{'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0000988', 'cui_str': 'Acetoacetates'}]",50.0,0.188971,Trimethylamine N-oxide concentration in plasma and urine were increased in the Cod-RP group compared with the Control group.,"[{'ForeName': 'Iselin', 'Initials': 'I', 'LastName': 'Vildmyren', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Halstensen', 'Affiliation': 'K. Halstensen AS, P.O. Box 103, 5399 Bekkjarvik, Norway.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'McCann', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021 Bergen, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Midttun', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021 Bergen, Norway.'}, {'ForeName': 'Per Magne', 'Initials': 'PM', 'LastName': 'Ueland', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021 Bergen, Norway.'}, {'ForeName': 'Åge', 'Initials': 'Å', 'LastName': 'Oterhals', 'Affiliation': 'Nofima, P.B. 1425 Oasen, 5844 Bergen, Norway.'}, {'ForeName': 'Oddrun Anita', 'Initials': 'OA', 'LastName': 'Gudbrandsen', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}]",Nutrients,['10.3390/nu12051445']
2761,31811627,Effect of a Single-Session Communication Skills Training on Empathy in Medical Students.,"OBJECTIVE


Empathy scores have been found to decline over the years spent in medical school. The authors aimed to evaluate the change in empathy levels in medical students following a single-session communication skills training.
METHODS


Eighty-two second-year medical students were randomized into intervention and control groups. The intervention comprised of a single-session empathetic communication skills training using PowerPoint, video clips, and roleplay. Empathy was assessed using the Jefferson Scale of Empathy-Student version (JSE) at baseline, post-intervention (for the intervention group), and at follow up after 3 weeks.
RESULTS


The mean JSE score of the intervention group was 109.7 ± 11.8 at baseline, with significant improvement post-intervention (114.2 ± 10.6, p = 0.014). However, the score declined at the 3-week follow-up (106.8 ± 11.8). The mean baseline JSE score of the control group was 107.5 ± 12.4, with a decline at follow-up (101.8 ± 16.0). Though both groups showed a decline in the JSE score at follow-up, the decline was significant only for the control group (p = 0.020), which did not receive the training.
CONCLUSIONS


The study showed significant improvement immediately, and lower decline at follow-up, in empathy levels following a communication skills training. The findings suggest a need to incorporate a regular training program into the existing medical curriculum, to enhance empathy and prevent its decline over the years.",2020,"Empathy was assessed using the Jefferson Scale of Empathy-Student version (JSE) at baseline, post-intervention (for the intervention group), and at follow up after 3 weeks.
","['Medical Students', 'Eighty-two second-year medical students', 'medical students following a single-session communication skills training']",['Single-Session Communication Skills Training'],"['Jefferson Scale of Empathy-Student version (JSE', 'JSE score', 'empathy levels', 'mean JSE score', 'mean baseline JSE score']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.0212813,"Empathy was assessed using the Jefferson Scale of Empathy-Student version (JSE) at baseline, post-intervention (for the intervention group), and at follow up after 3 weeks.
","[{'ForeName': 'Prima Cheryl', 'Initials': 'PC', 'LastName': ""D'souza"", 'Affiliation': 'Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Smitha L', 'Initials': 'SL', 'LastName': 'Rasquinha', 'Affiliation': 'Father Muller Medical College, Mangalore, Karnataka, India. smithaljr@gmail.com.'}, {'ForeName': 'Trina Lucille', 'Initials': 'TL', 'LastName': ""D'souza"", 'Affiliation': 'Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Animesh', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Vaman', 'Initials': 'V', 'LastName': 'Kulkarni', 'Affiliation': 'Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Keshava', 'Initials': 'K', 'LastName': 'Pai', 'Affiliation': 'Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]",Academic psychiatry : the journal of the American Association of Directors of Psychiatric Residency Training and the Association for Academic Psychiatry,['10.1007/s40596-019-01158-z']
2762,32434399,Pre-eclampsia screening in the first trimester - preemptive action to prevent the peril.,"Pre-eclampsia complicating 2-5% of pregnancies is an obstetrical syndrome associated with deleterious short-and long-term consequences to the gravid women, the fetus and the neonate. Majority of the obstetrical complications occur in early pre-eclampsia (requiring delivery <34 weeks). The risk factor based approach recommended by the professional organizations for pre-eclampsia screening has shown suboptimal clinical performance. The combined multimarker screening for pre-eclampsia encompassing documentation of maternal medical history, measurement of mean arterial pressure, estimation of the maternal serum levels of placental growth factor, pregnancy associated plasma protein-A, and recording the Uterine artery mean pulsatility index, performed in the first trimester between 11 and 13 + 6 weeks has proven to be an effective screening strategy. The a-priori risk is determined by multivariate analysis of the factors from history, while the other parameters are converted to log 10 transformed multiple of median values. Bayes' theorem is used to calculate the final risk. The above model has shown to detect 77% of preterm pre-eclampsia (<37 weeks), 96% of early preterm pre-eclampsia (<34 weeks), 38% of term pre-eclampsia and 54% of all pre-eclampsia, at a false positive rate of 10%. Uterine artery Doppler is key to pre-eclampsia screening. Currently a risk of >1:100 for pre-eclampsia developing before 37 weeks (preterm pre-eclampsia) is regarded as screen positive. Aspirin at a dose of 150 mg at bedtime given to screen positive subjects is associated with a significant reduction of preterm pre-eclampsia and early pre-eclampsia. The intervention is now supported by a well conducted randomized trial and metanalysis data. Aspirin acts by diminishing stores of constitutive cyclooxygenase enzyme in the non-nucleated platelets without disturbing systemic prostaglandin production. Selective use of aspirin in screen positive women is associated with a very low incidence of adverse maternal, fetal and neonatal side effects. The screening protocol can be applied to twin pregnancies albeit minor differences. Hence, screening for pre-eclampsia in first trimester, which is now endorsed by the federation of international obstetrical and gynecological societies, should be offered universally to all women at 11 to 13 + 6 weeks of gestation, followed by the administration of aspirin and serial maternal-fetal surveillance in the screen positive woman.",2020,Aspirin acts by diminishing stores of constitutive cyclooxygenase enzyme in the non-nucleated platelets without disturbing systemic prostaglandin production.,['screen positive women'],"['Aspirin', 'aspirin']","['preterm pre-eclampsia and early pre-eclampsia', 'eclampsia screening', 'mean arterial pressure, estimation of the maternal serum levels of placental growth factor, pregnancy associated plasma protein-A, and recording the Uterine artery mean pulsatility index']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013537', 'cui_str': 'Eclampsia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0138514', 'cui_str': 'Placenta Growth Factor'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}]",,0.101263,Aspirin acts by diminishing stores of constitutive cyclooxygenase enzyme in the non-nucleated platelets without disturbing systemic prostaglandin production.,"[{'ForeName': 'Seneesh Kumar', 'Initials': 'SK', 'LastName': 'Vikraman', 'Affiliation': 'Center for Prenatal diagnosis and Fetal therapy, ARMC AEGIS Hospital,\xa0Perinthalmana, Kerala, India.'}, {'ForeName': 'Rinshi Abid', 'Initials': 'RA', 'LastName': 'Elayedatt', 'Affiliation': 'Department of Fetal Medicine, Nahas Hospital, Malappuram, Kerala, India.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1767059']
2763,32434498,"Autologous adipose tissue injection versus platelet-rich plasma (PRP) injection in the treatment of knee osteoarthritis: a randomized, controlled study - study protocol.","BACKGROUND


Knee osteoarthritis (OA) is a common, chronic, progressive and degenerative disease which affects patients' quality of life and may cause disability and social isolation. OA is a huge economic burden for the patient and a large strain for the whole healthcare system. Articular cartilage has a small potential to repair, with progressively more clinicians emphasizing cellular therapy. Subcutaneous fat tissue in human body is a large reservoir of mesenchymal stem cells (MSCs) and is been harvested in minimally invasive, simple procedure. Up to date there is no prospective randomized controlled studies demonstrating effectiveness and role of adipose tissue injections in OA treatment. The purpose of this study is to assess functional and clinical changes among patients with symptomatic knee OA treated with intra-articular injections of autologous adipose tissue or platelet rich plasma (PRP) and to compare efficacy of both therapeutic methods.
METHODS


This is a prospective, randomized, controlled study. Patients who meet inclusion criteria will be allocated to Fat Tissue group or PRP group randomly. Subjects will receive an intra articular injection with autologous adipose tissue and PRP respectively. Patients will be assessed five times: before treatment and 1, 3, 6 and 12 months after the treatment. The assessment consists of patient reported outcome measures (The Knee injury and Osteoarthritis Outcome Score, International Knee Documentation Committee 2000, the Western Ontario and McMaster Universities Osteoarthritis Index, the Health Questionnaire EQ- 5D- 5 L), three functional tests (The Timed Up and Go Test, The 5 Times Sit to Stand Test, The 10 m Walk Test) and Maximal Isometric Voluntary Contraction.
DISCUSSION


This study protocol has several strengths and weaknesses. One of strongest point of this study is the wide, multidimensional functional assessment which will give a large amount of objective data. On the other hand, lack of blinding has to be considered as a risk of both subject and investigator bias.
TRIAL REGISTRATION


name of registry: ClinicalTrials.gov, trial registration number: NCT04321629, retrospectively registered on date of registration.",2020,"5D- 5 L), three functional tests (The Timed Up and Go Test, The 5 Times Sit to Stand Test, The 10 m Walk Test) and Maximal Isometric Voluntary Contraction.
","['knee osteoarthritis', 'patients with symptomatic knee OA treated with']","['Autologous adipose tissue injection versus platelet-rich plasma (PRP) injection', 'intra-articular injections of autologous adipose tissue or platelet rich plasma (PRP', 'Fat Tissue group or PRP', 'OA']","['Knee injury and Osteoarthritis Outcome Score, International Knee Documentation Committee 2000, the Western Ontario and McMaster Universities Osteoarthritis Index, the Health Questionnaire EQ']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0666242,"5D- 5 L), three functional tests (The Timed Up and Go Test, The 5 Times Sit to Stand Test, The 10 m Walk Test) and Maximal Isometric Voluntary Contraction.
","[{'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Bąkowski', 'Affiliation': 'Department of Orthopedic Surgery, Rehasport Clinic, Poznan, Poland. pawel.bakowski@rehasport.pl.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Kaszyński', 'Affiliation': 'Department of Orthopedic Surgery, Rehasport Clinic, Poznan, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wałecka', 'Affiliation': 'Department of Orthopedic Surgery, Rehasport Clinic, Poznan, Poland.'}, {'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Ciemniewska-Gorzela', 'Affiliation': 'Department of Orthopedic Surgery, Rehasport Clinic, Poznan, Poland.'}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'Bąkowska-Żywicka', 'Affiliation': 'Institute of Bioorganic Chemistry Polish Academy of Sciences, Poznan, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Piontek', 'Affiliation': 'Department of Orthopedic Surgery, Rehasport Clinic, Poznan, Poland.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03345-8']
2764,32434761,A School-Based Intervention for Mental Illness Stigma: A Cluster Randomized Trial.,"OBJECTIVES


To determine the effectiveness of a school-based curriculum, Eliminating the Stigma of Differences (ESD), in improving attitudinal and/or behavioral contexts regarding mental illness in schools and increasing the likelihood that youth seek treatment for mental health problems when needed.
METHODS


We conducted a cluster randomized trial in sixth-grade classes from 14 schools in 2011 and 2012 with follow-up at 6-month intervals through 24 months (2012-2015). Using a fully crossed 2 × 2 × 2 factorial design, we compared ESD to a no-intervention control and to 2 comparator interventions: (1) contact with 2 young adults with a history of mental illness and (2) exposure to antistigma printed materials. We implemented interventions in classrooms in an ethnically and socioeconomically diverse school district. There were 416 youth who participated in the follow-up, and 312 (75%) of these participated for the full 2 years. Outcome measures were knowledge and positive attitudes, social distance from peers with mental illness, and mental health treatment seeking.
RESULTS


Youth assigned to ESD reported greater knowledge and positive attitudes and reduced social distance (Cohen's d = 0.35 and 0.16, respectively) than youth in the comparator interventions and no-intervention groups across the 2-year follow-up. Youth with high levels of mental health symptoms were more likely (odds ratio = 3.51; confidence interval = 1.08-11.31) to seek treatment during follow-up if assigned to ESD than if they were assigned to comparator interventions or no intervention.
CONCLUSIONS


ESD shows potential for improving the social climate related to mental illnesses in schools and increasing treatment seeking when needed. ESD and interventions like it show promise as part of a public mental health response to youth with mental health needs in schools.",2020,"Youth with high levels of mental health symptoms were more likely (odds ratio = 3.51; confidence interval = 1.08-11.31) to seek treatment during follow-up if assigned to ESD than if they were assigned to comparator interventions or no intervention.
","['416 youth who participated in the follow-up, and 312 (75%) of these participated for the full 2 years', 'sixth-grade classes from 14 schools in 2011 and 2012 with follow-up at 6-month intervals through 24 months (2012-2015', 'classrooms in an ethnically and socioeconomically diverse school district', 'Mental Illness Stigma']",['ESD to a no-intervention control and to 2 comparator interventions: (1) contact with 2 young adults with a history of mental illness and (2) exposure to antistigma printed materials'],"['mental health symptoms', 'knowledge and positive attitudes, social distance from peers with mental illness, and mental health treatment seeking', 'knowledge and positive attitudes and reduced social distance']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}]",2.0,0.0591902,"Youth with high levels of mental health symptoms were more likely (odds ratio = 3.51; confidence interval = 1.08-11.31) to seek treatment during follow-up if assigned to ESD than if they were assigned to comparator interventions or no intervention.
","[{'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Link', 'Affiliation': 'Department of Sociology, School of Public Policy, University of California, Riverside, Riverside, California; bruce.link@ucr.edu.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'DuPont-Reyes', 'Affiliation': 'Latino Research Institute, The University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Barkin', 'Affiliation': 'Mental Health Connection of Tarrant County, Fort Worth, Texas.'}, {'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Villatoro', 'Affiliation': 'Latino Research Institute, The University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Jo C', 'Initials': 'JC', 'LastName': 'Phelan', 'Affiliation': 'Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, New York; and.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Painter', 'Affiliation': 'School of Social Work, University of Texas Arlington, Arlington, Texas.'}]",Pediatrics,['10.1542/peds.2019-0780']
2765,32434376,Comparison of Auricular Therapy with Sham in Children with Attention Deficit/Hyperactivity Disorder: A Randomized Controlled Trial.,"Objectives:  Several studies have shown the clinical effects of auricular therapy for some neuropsychological disorders. The aim of this study is to compare the effectiveness of auricular therapy with the sham procedure in attention deficit hyperactivity disorder (ADHD).  Design:  Randomized sham-controlled trial.  Settings/Location:  Welfare Centers of Tehran (Iran).  Subjects:  Fifty children with ADHD (6-14 years old).  Interventions:  Patients were randomly assigned into two groups to receive either auricular therapy (Group A) or a sham procedure (Group B) once a week for 6 weeks.  Outcome measures:  The Children Symptom Inventory (CSI-4) and the parent's version of the Conners Comprehensive Behavior Rating Scale were used to assess the severity of symptoms of attention deficit (AD) and hyperactivity (HA). Outcome evaluation data was obtained at the first and seventh weeks after the interventions. Data were analyzed by SPSS software using Friedman and Mann-Whitney  U  tests.  Results:  There were 23 patients in group A and 21 patients in group B who completed the study. Based on the CSI-4 assessment, AD scores decreased from the mean (±standard deviation) of 18.39 (±5.44) to 15.39 (±5.89),  p  = 0.006 in group A, whereas the mean AD scores for group B only changed from 15.0 (±6.4) to 14.9 (±5.94),  p  = 0.55 in group B. In addition, the mean of the HA scores decreased from 18.0 (±6.73) to 13.3 (±6.75),  p  = 0.001 in group A, whereas the change in HA scores in group B only diminished and from 11.85 (±6.44) to 11.45 (±5.44),  p  = 0.74. The CSI-4 assessments and the scores on the Conners questionnaire significantly decreased after the first week of intervention ( p  = 0.04) in group A, but not in group B. No side effects were observed.  Conclusion:  Subjects who received auricular therapy in acupuncture points achieved a statistically significant greater reduction in AD and HA symptoms when compared with subjects who received sham acupuncture points.",2020,"The CSI-4 assessments and the scores on the Conners questionnaire significantly decreased after the first week of intervention ( p  = 0.04) in group A, but not in group B. No side effects were observed.  ","['Subjects:  Fifty children with ADHD (6-14 years old', 'Settings/Location:  Welfare Centers of Tehran (Iran', '23 patients in group A and 21 patients in group B who completed the study', 'Children with Attention Deficit/Hyperactivity Disorder']","['auricular therapy', 'auricular therapy in acupuncture points', 'Auricular Therapy with Sham']","[""Children Symptom Inventory (CSI-4) and the parent's version of the Conners Comprehensive Behavior Rating Scale"", 'CSI-4 assessment, AD scores', 'AD and HA symptoms', 'mean AD scores', 'severity of symptoms of attention deficit (AD) and hyperactivity (HA', 'CSI-4 assessments and the scores on the Conners questionnaire', 'mean of the HA scores', 'change in HA scores', 'side effects']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3494227', 'cui_str': 'Spinocranial Irradiation'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0475483', 'cui_str': 'Behavior rating scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",50.0,0.0874341,"The CSI-4 assessments and the scores on the Conners questionnaire significantly decreased after the first week of intervention ( p  = 0.04) in group A, but not in group B. No side effects were observed.  ","[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Binesh', 'Affiliation': 'Department of Research, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Daghighi', 'Affiliation': 'Department of Psychiatry, Aja University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Shirazi', 'Affiliation': 'Spiritual Health Research Center, Tehran Institute of Psychiatry, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Oleson', 'Affiliation': ""Department of Traditional Oriental Medicine, Emperor's College of Traditional Oriental Medicine, Santa Monica, CA, USA.""}, {'ForeName': 'Fataneh', 'Initials': 'F', 'LastName': 'Hashem-Dabaghian', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0477']
2766,32434495,Effect of sevoflurane and propofol on tourniquet-induced endothelial damage: a pilot randomized controlled trial for knee-ligament surgery.,"BACKGROUND


The glycocalyx layer is a key structure in the endothelium. Tourniquet-induced ischemic periods are used during orthopedic surgery, and the reactive oxygen species generated after ischemia-reperfusion may mediate the shedding of the glycocalyx. Here, we describe the effects of tourniquet-induced ischemia-reperfusion and compare the effects of sevoflurane and propofol on the release of endothelial biomarkers after ischemia-reperfusion in knee-ligament surgery.
METHODS


This pilot, single-center, blinded, randomized, controlled trial included 16 healthy patients. After spinal anesthesia, hypnosis was achieved with sevoflurane or propofol according to randomization. During the perioperative period, five venous blood samples were collected for quantification of syndecan-1, heparan sulfate, and thrombomodulin from blood serum by using ELISA assays kits. Sample size calculation was performed to detect a 25% change in the mean concentration of syndecan-1 with an alpha of 0.05 and power of 80%.
RESULTS


For our primary outcome, a two-way ANOVA with post-hoc Bonferroni correction analysis showed no differences in syndecan-1 concentrations between the sevoflurane and propofol groups at any time point. In the sevoflurane group, we noted an increase in syndecan-1 concentrations 90 min after tourniquet release in the sevoflurane group from 34.6 ± 24.4 ng/mL to 47.9 ± 29.8 ng/mL (Wilcoxon test, p < 0.01) that was not observed in patients randomized to the propofol group. The two-way ANOVA showed no intergroup differences in heparan sulfate and thrombomodulin levels.
CONCLUSIONS


Superficial endothelial damage without alterations in the cell layer integrity was observed after tourniquet knee-ligament surgery. There was no elevation in serum endothelial biomarkers in the propofol group patients. Sevoflurane did not show the protective effect observed in in vitro and in vivo studies.
TRIAL REGISTRATION


The trial was registered in www.clinicaltrials.gov (ref: NCT03772054, Registered 11 December 2018).",2020,"In the sevoflurane group, we noted an increase in syndecan-1 concentrations 90 min after tourniquet release in the sevoflurane group from 34.6 ± 24.4 ng/mL to 47.9 ± 29.8 ng/mL (Wilcoxon test, p < 0.01) that was not observed in patients randomized to the propofol group.","['16 healthy patients', 'knee-ligament surgery']","['sevoflurane and propofol', 'tourniquet-induced ischemia-reperfusion', 'sevoflurane', 'propofol', 'sevoflurane or propofol', 'Sevoflurane']","['syndecan-1 concentrations 90\u2009min after tourniquet release', 'endothelial biomarkers', 'cell layer integrity', 'syndecan-1 concentrations', 'serum endothelial biomarkers', 'heparan sulfate and thrombomodulin levels', 'tourniquet-induced endothelial damage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0412803', 'cui_str': 'Tourniquet release'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019143', 'cui_str': 'Heparan sulfate'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",16.0,0.215818,"In the sevoflurane group, we noted an increase in syndecan-1 concentrations 90 min after tourniquet release in the sevoflurane group from 34.6 ± 24.4 ng/mL to 47.9 ± 29.8 ng/mL (Wilcoxon test, p < 0.01) that was not observed in patients randomized to the propofol group.","[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Maldonado', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine. Hospital Clínico de la Universidad de Chile. Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Morales', 'Affiliation': 'Program of Cellular and Molecular Biology, Institute of Biomedical Sciences (ICBM), Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Gutiérrez', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine. Hospital Clínico de la Universidad de Chile. Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Maximiliano', 'Initials': 'M', 'LastName': 'Barahona', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Cerda', 'Affiliation': 'Program of Cellular and Molecular Biology, Institute of Biomedical Sciences (ICBM), Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Cáceres', 'Affiliation': 'Program of Cellular and Molecular Biology, Institute of Biomedical Sciences (ICBM), Faculty of Medicine, Universidad de Chile, Santiago, Chile. monicacaceres@med.uchile.cl.'}]",BMC anesthesiology,['10.1186/s12871-020-01030-w']
2767,32434666,Transcutaneous electrical nerve stimulation and heat to reduce pain in a chronic low back pain population: a randomized controlled clinical trial.,"BACKGROUND


Low back pain is the leading cause of disability worldwide. The therapeutic management of patients with chronic LBP is challenging.
OBJECTIVES


The aim of this study is to evaluate the effects of heat and transcutaneous electrical nerve stimulation combined on pain relief in participants with chronic low back pain.
METHODS


Fifty participants with chronic (≥3 months) low back pain were randomly assigned to two groups: HeatTens (n=25) and control group (n=25). Primary outcome was pain. Secondary outcomes were pressure pain thresholds, temporal summation, conditioned pain modulation, fear-avoidance and beliefs questionnaire, central sensitization inventory, quality of life, and medication use. The control group received no treatment and continued usual care. After four weeks of treatment, all measurements were repeated.
RESULTS


Fifty individuals participated in this study. Significant higher pressure pain threshold measures after both 30min and 4 weeks for the lower back region and the second plantar toe were found only in the experimental group.
CONCLUSION


The combination of heat and transcutaneous electrical nerve stimulation does not reduce pain scores in patients with chronic low back pain. Pressure pain threshold values significantly improved, showing beneficial effects of the experimental treatment. ClinicalTrials.gov: NCT03643731 (https://clinicaltrials.gov/ct2/show/NCT03643731).",2020,"Significant higher pressure pain threshold measures after both 30min and 4 weeks for the lower back region and the second plantar toe were found only in the experimental group.
","['patients with chronic low back pain', 'participants with chronic low back pain', 'Fifty participants with chronic (≥3 months) low back pain', 'chronic low back pain population', 'patients with chronic LBP', 'Fifty individuals participated in this study']","['heat and transcutaneous electrical nerve stimulation combined', 'Transcutaneous electrical nerve stimulation and heat to reduce pain', 'no treatment and continued usual care', 'heat and transcutaneous electrical nerve stimulation']","['pain scores', 'pain relief', 'Pressure pain threshold values', 'pressure pain thresholds, temporal summation, conditioned pain modulation, fear-avoidance and beliefs questionnaire, central sensitization inventory, quality of life, and medication use', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",50.0,0.110104,"Significant higher pressure pain threshold measures after both 30min and 4 weeks for the lower back region and the second plantar toe were found only in the experimental group.
","[{'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Leemans', 'Affiliation': 'Rehabilitation Research Department, Vrije Universiteit Brussel, Brussels, Belgium; Pain in Motion International Research Group, Belgium. Electronic address: Lynn.Leemans@vub.be.'}, {'ForeName': 'Ömer', 'Initials': 'Ö', 'LastName': 'Elma', 'Affiliation': 'Pain in Motion International Research Group, Belgium.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Nijs', 'Affiliation': 'Pain in Motion International Research Group, Belgium; Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Belgium.'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Wideman', 'Affiliation': 'School of Physical and Occupational Therapy, McGill University, Canada.'}, {'ForeName': 'Carolie', 'Initials': 'C', 'LastName': 'Siffain', 'Affiliation': 'Rehabilitation Research Department, Vrije Universiteit Brussel, Brussels, Belgium; Pain in Motion International Research Group, Belgium.'}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'den Bandt', 'Affiliation': 'Pain in Motion International Research Group, Belgium; Department of Physiotherapy, University of Applied Sciences Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Van Laere', 'Affiliation': 'Interfaculty Center Data Processing and Statistics, Vrije Universiteit Brussel, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Beckwée', 'Affiliation': 'Rehabilitation Research Department, Vrije Universiteit Brussel, Brussels, Belgium; Frailty in Ageing Research Department, Vrije Universiteit Brussel, Brussels, Belgium; Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2020.04.001']
2768,32434686,Corrigendum to 'Efficacy and safety of food fortification to improve Vitamin D intakes of older adults' [Nutrition 75-76 (2020)].,,2020,,"[""older adults' [Nutrition 75-76 (2020""]",['food fortification'],['Vitamin D intakes'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0564439', 'cui_str': 'Vitamin D intake'}]",,0.01844,,"[{'ForeName': 'Aislinn', 'Initials': 'A', 'LastName': 'McCourt', 'Affiliation': 'UCD Institute of Food and Health, University College Dublin, Belfield, Dublin 4, Ireland.'}, {'ForeName': 'Breige A', 'Initials': 'BA', 'LastName': 'McNulty', 'Affiliation': 'UCD Institute of Food and Health, University College Dublin, Belfield, Dublin 4, Ireland.'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Walton', 'Affiliation': 'School of Biological Sciences, Cork Institute of Technology, Cork, Ireland.'}, {'ForeName': 'Aifric', 'Initials': 'A', 'LastName': ""O'Sullivan"", 'Affiliation': 'UCD Institute of Food and Health, University College Dublin, Belfield, Dublin 4, Ireland. Electronic address: Aifric.osullivan@ucd.ie.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110837']
2769,32434972,Comparative Evaluation of Casein Phosphopeptide-Amorphous Calcium Phosphate-Fluoride Paste and Sodium Fluoride Mouthwash in the Prevention of Dental Erosion: An  In Vitro  Study.,"AIM


To compare the efficacy of casein phosphopeptide-amorphous calcium phosphate-fluoride (CPP-ACP-F) paste and 0.2% sodium fluoride mouthwash in the prevention of dental erosion using profilometer.
MATERIALS AND METHODS


The buccal surfaces of 36 premolar sound teeth were ground and polished to achieve a flat surface with silicone disks. Samples were allocated in three groups randomly. Group I was pretreated for 5 days four times a day with CPP-ACP-F paste. Group II was pretreated for 5 days with 0.2% sodium fluoride mouthwash four times a day. Group III remained as the control group without any pretreatment. In the next step, all the samples were exposed four times a day for 3 days to carbonated beverages. The samples were rinsed with saline after each erosive cycle and stored in artificial saliva. The profilometer was used to determine the surface loss. The data collected were evaluated using one-way analysis of variance (ANOVA) along with  post hoc  test.
RESULTS


The erosion of group I (CPP-ACP-F paste) and group II (0.2% sodium fluoride mouthwash) was significantly less than that of group III (control group). The erosion in group II was significantly lower than in group I.
CONCLUSION


Both sodium fluoride mouthwash and CPP-ACP-F paste are effective in the prevention of dental erosion. Sodium fluoride mouthwash shows higher reduction in dental erosion when compared with CPP-ACP-F paste.
CLINICAL SIGNIFICANCE


This study contributes to the understanding of the efficacy of CPP-ACP-F paste and 0.2% sodium fluoride mouthwash in the prevention of dental erosion.",2020,"The erosion in group II was significantly lower than in group I.
CONCLUSION


Both sodium fluoride mouthwash and CPP-ACP-F paste are effective in the prevention of dental erosion.",['Dental Erosion'],"['Sodium fluoride mouthwash', 'Casein Phosphopeptide-Amorphous Calcium Phosphate-Fluoride Paste and Sodium Fluoride Mouthwash', 'CPP-ACP-F paste and 0.2% sodium fluoride mouthwash', 'casein phosphopeptide-amorphous calcium phosphate-fluoride (CPP-ACP-F) paste and 0.2% sodium fluoride mouthwash', 'sodium fluoride mouthwash and CPP-ACP-F paste', 'CPP-ACP-F paste']",['dental erosion'],"[{'cui': 'C0040436', 'cui_str': 'Erosion of teeth'}]","[{'cui': 'C0359569', 'cui_str': 'Sodium Fluoride Mouthwash'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0040436', 'cui_str': 'Erosion of teeth'}]",36.0,0.0144286,"The erosion in group II was significantly lower than in group I.
CONCLUSION


Both sodium fluoride mouthwash and CPP-ACP-F paste are effective in the prevention of dental erosion.","[{'ForeName': 'Beulah M', 'Initials': 'BM', 'LastName': 'Bejoy', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Annoor Dental College and Hospital, Perumattom, Muvattupuzha, Kerala, India, Phone: +91 9747656740, e-mail: beulahbejoy91@gmail.com.'}, {'ForeName': 'Moonnamkoottu S', 'Initials': 'MS', 'LastName': 'Sruthi', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Annoor Dental College and Hospital, Perumattom, Muvattupuzha, Kerala, India.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'George', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Annoor Dental College and Hospital, Perumattom, Muvattupuzha, Kerala, India.'}, {'ForeName': 'Josey', 'Initials': 'J', 'LastName': 'Mathew', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Annoor Dental College and Hospital, Perumattom, Muvattupuzha, Kerala, India.'}, {'ForeName': 'Raveendran Pv', 'Initials': 'RP', 'LastName': 'Vineet', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Annoor Dental College and Hospital, Perumattom, Muvattupuzha, Kerala, India.'}, {'ForeName': 'Aleesha', 'Initials': 'A', 'LastName': 'Joy', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Annoor Dental College and Hospital, Perumattom, Muvattupuzha, Kerala, India.'}]",The journal of contemporary dental practice,[]
2770,32434974,Influence of Temperature on the Cyclic Fatigue Resistance of Reciproc Blue Instruments.,"AIM


To evaluate the cyclic fatigue resistance of Reciproc blue (RB) 40/0.06 instruments tested at room temperature (20° ± 0.5°C) and at body temperature (37° ± 0.5°C) in a simulated stainless steel canal.
MATERIALS AND METHODS


Twenty-four new RB 40/0.06 instruments were randomly divided into two groups ( n  = 12) according to the temperature used. Dynamic fatigue testing was performed using an artificial stainless steel canal with a 60° curvature angle and a 5-mm radius of curvature. The temperature was controlled throughout the experiment with an underwater thermometer and a thermostat. The data were analyzed descriptively using the IBM SPSS 23.0 program, considering  p  < 0.05.
RESULTS


The time to fracture of the RB instruments differed significantly between the two temperatures (1083.82 seconds at 20°C and 403.80 seconds at 37°C). No significant differences were found in fragment size.
CONCLUSION


An increase in temperature reduces the cyclic fatigue resistance of RB 40/0.06 instruments. The results of the study suggest that an intracanal cooling system can be favorable to the fracture resistance of the tested instruments.
CLINICAL SIGNIFICANCE


A cooling system of the root canal system is important in endodontic as it favors the cyclic fatigue resistance of Ni-Ti instruments.",2020,The time to fracture of the RB instruments differed significantly between the two temperatures (1083.82 seconds at 20°C and 403.80 seconds at 37°C).,['Twenty-four'],['Reciproc blue (RB'],"['time to fracture of the RB instruments', 'fracture resistance', 'fragment size']","[{'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0258926,The time to fracture of the RB instruments differed significantly between the two temperatures (1083.82 seconds at 20°C and 403.80 seconds at 37°C).,"[{'ForeName': 'Thalita M', 'Initials': 'TM', 'LastName': 'Vieira', 'Affiliation': 'Department of Operative Dentistry and Endodontics, University of Pernambuco, Camaragibe, Pernambuco, Brazil, Phone: +55 81996657107, e-mail: thalitamv10@gmail.com.'}, {'ForeName': 'Nayane Cc', 'Initials': 'NC', 'LastName': 'Alves', 'Affiliation': 'Department of Operative Dentistry and Endodontics, School of Dentistry of Pernambuco/University of Pernambuco, Camaragibe, Pernambuco, Brazil.'}, {'ForeName': 'Silmara', 'Initials': 'S', 'LastName': 'de Andrade Silva', 'Affiliation': 'Department of Operative Dentistry and Endodontics, School of Dentistry of Pernambuco/University of Pernambuco, Camaragibe, Pernambuco, Brazil.'}, {'ForeName': 'Andressa C', 'Initials': 'AC', 'LastName': 'de Almeida', 'Affiliation': 'Department of Operative Dentistry and Endodontics, School of Dentistry of Pernambuco/University of Pernambuco, Camaragibe, Pernambuco, Brazil.'}, {'ForeName': 'Christianne Tv', 'Initials': 'CT', 'LastName': 'Telles', 'Affiliation': 'Department of Operative Dentistry and Endodontics, School of Dentistry of Pernambuco/University of Pernambuco, Camaragibe, Pernambuco, Brazil.'}, {'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Albuquerque', 'Affiliation': 'Department of Operative Dentistry and Endodontics, University of Pernambuco, Camaragibe, Pernambuco, Brazil.'}]",The journal of contemporary dental practice,[]
2771,32434975,Evaluation of Different Local Drug Delivery Systems in the Management of Chronic Periodontitis: A Comparative Study.,"AIM


The present study aimed to assess the use of various local drug delivery systems in the management of chronic periodontitis.
MATERIALS AND METHODS


A total of 60 patients aged around 30-55 years were included. The subjects who were enrolled under took a phase I therapy that included scaling and root planing (SRP). Patients who satisfied the conditions for selection to enter the trial were assigned randomly to three groups, with each group consisting of 20 participants as follows: group I: controlled-release drugs-chlorhexidine gel, group II: metronidazole gel, group III: tetracycline fibers. The plaque index (PI), gingival index (GI), and periodontal pocket depth (PPD) were recorded after 1st week as the baseline data and were recorded again after 15 days and 30 days post-baseline.
RESULTS


The mean GI scores were 1.32 ± 0.10, 0.88 ± 0.16, and 0.76 ± 0.12, at baseline, 15 days, and 30 days, respectively, in group I. In group II, the mean GI score reduced to 1.09 ± 0.83 at 30 days from 1.48 ± 0.27 at baseline. Likewise, in group III the mean GI score reduced to 0.90 ± 0.62 at 30 days from 1.38 ± 0.06 at baseline. All the groups demonstrated a statistically significant difference at various intervals. The mean PI score decreased to 0.90 ± 0.78 at 15 days from 1.46 ± 0.22 at baseline in group III. A statistically significant difference at different intervals was seen in group III only. In all groups, the intergroup comparison of PPD was found to be statistically significant.
CONCLUSION


This study demonstrated that although thorough SRP is an effective treatment method for elimination of chronic periodontal pockets, improved results can be obtained by adjunctive use of locally administered chlorhexidine gel, metronidazole gel, and tetracycline fibers.
CLINICAL SIGNIFICANCE


The use of the adjunctive local drug delivery system along with mechanical cleansing in the treatment of periodontal pockets in chronic periodontitis is therapeutically beneficial.",2020,"The plaque index (PI), gingival index (GI), and periodontal pocket depth (PPD) were recorded after 1st week as the baseline data and were recorded again after 15 days and 30 days post-baseline.
","['60 patients aged around 30-55 years were included', 'Chronic Periodontitis', 'subjects who were enrolled under took a phase I therapy that included scaling and root planing (SRP', 'Patients who satisfied the conditions for selection to enter the trial']","['SRP', 'metronidazole gel, group III: tetracycline fibers', 'mechanical cleansing', 'chlorhexidine gel', 'chlorhexidine gel, metronidazole gel, and tetracycline fibers']","['mean GI scores', 'mean GI score', 'mean PI score', 'plaque index (PI), gingival index (GI), and periodontal pocket depth (PPD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",60.0,0.0215189,"The plaque index (PI), gingival index (GI), and periodontal pocket depth (PPD) were recorded after 1st week as the baseline data and were recorded again after 15 days and 30 days post-baseline.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Abraham', 'Affiliation': 'Department of Periodontics, Educare Institute of Dental Sciences, Malappuram, Kerala, India, Phone: +91 9995885339, e-mail: annachally@yahoo.com.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Raghavan', 'Affiliation': 'Department of Periodontics, Educare Institute of Dental Sciences, Malappuram, Kerala, India.'}, {'ForeName': 'Ajesh', 'Initials': 'A', 'LastName': 'Joseph', 'Affiliation': 'Department of Periodontics, Educare Institute of Dental Sciences, Malappuram, Kerala, India.'}, {'ForeName': 'M P Shyamala', 'Initials': 'MPS', 'LastName': 'Devi', 'Affiliation': 'Department of Periodontics, PSM College of Dental Sciences and Research, Thrissur, Kerala, India.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Varghese', 'Affiliation': 'Department of Periodontics, PSM College of Dental Sciences and Research, Thrissur, Kerala, India.'}, {'ForeName': 'P V', 'Initials': 'PV', 'LastName': 'Sreedevi', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, PSM College of Dental Sciences and Research, Thrissur, Kerala, India.'}]",The journal of contemporary dental practice,[]
2772,32434996,Monounsaturated fat rapidly induces hepatic gluconeogenesis and whole-body insulin resistance.,"BACKGROUNDWhile saturated fat intake leads to insulin resistance and nonalcoholic fatty liver, Mediterranean-like diets enriched in monounsaturated fatty acids (MUFA) may have beneficial effects. This study examined effects of MUFA on tissue-specific insulin sensitivity and energy metabolism.METHODSA randomized placebo-controlled cross-over study enrolled 16 glucose-tolerant volunteers to receive either oil (OIL, ~1.18 g/kg), rich in MUFA, or vehicle (VCL, water) on 2 occasions. Insulin sensitivity was assessed during preclamp and hyperinsulinemic-euglycemic clamp conditions. Ingestion of 2H2O/acetaminophen was combined with [6,6-2H2]glucose infusion and in vivo 13C/31P/1H/ex vivo 2H-magnet resonance spectroscopy to quantify hepatic glucose and energy fluxes.RESULTSOIL increased plasma triglycerides and oleic acid concentrations by 44% and 66% compared with VCL. Upon OIL intervention, preclamp hepatic and whole-body insulin sensitivity markedly decreased by 28% and 27%, respectively, along with 61% higher rates of hepatic gluconeogenesis and 32% lower rates of net glycogenolysis, while hepatic triglyceride and ATP concentrations did not differ from VCL. During insulin stimulation hepatic and whole-body insulin sensitivity were reduced by 21% and 25%, respectively, after OIL ingestion compared with that in controls.CONCLUSIONA single MUFA-load suffices to induce insulin resistance but affects neither hepatic triglycerides nor energy-rich phosphates. These data indicate that amount of ingested fat, rather than its composition, primarily determines the development of acute insulin resistance.TRIAL REGISTRATIONClinicalTrials.gov NCT01736202.FUNDINGGerman Diabetes Center, German Federal Ministry of Health, Ministry of Culture and Science of the state of North Rhine-Westphalia, German Federal Ministry of Education and Research, German Diabetes Association, German Center for Diabetes Research, Portugal Foundation for Science and Technology, European Regional Development Fund, and Rede Nacional de Ressonancia Magnética Nuclear.",2020,"During insulin stimulation hepatic and whole-body insulin sensitivity were reduced by 21% and 25%, respectively, after OIL ingestion compared with that in controls.",['controlled cross-over study enrolled 16 glucose-tolerant volunteers'],"['2H2O/acetaminophen', 'oil (OIL, ~1.18 g/kg), rich in MUFA, or vehicle (VCL, water', 'MUFA', 'placebo']","['insulin stimulation hepatic and whole-body insulin sensitivity', 'hepatic glucose and energy fluxes', 'tissue-specific insulin sensitivity and energy metabolism', 'hepatic gluconeogenesis and whole-body insulin resistance', 'hepatic gluconeogenesis', 'preclamp hepatic and whole-body insulin sensitivity', 'Insulin sensitivity', 'plasma triglycerides and oleic acid concentrations', 'rates of net glycogenolysis, while hepatic triglyceride and ATP concentrations']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C1454484', 'cui_str': 'VCL protein, human'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0017715', 'cui_str': 'Gluconeogenesis'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0028928', 'cui_str': '9 cis-octadecenoic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0596624', 'cui_str': 'Glycogenolysis'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}]",,0.110362,"During insulin stimulation hepatic and whole-body insulin sensitivity were reduced by 21% and 25%, respectively, after OIL ingestion compared with that in controls.","[{'ForeName': 'Theresia', 'Initials': 'T', 'LastName': 'Sarabhai', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Kahl', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Szendroedi', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Markgraf', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Oana-Patricia', 'Initials': 'OP', 'LastName': 'Zaharia', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Barosa', 'Affiliation': 'Centre for Neurosciences and Cell Biology, UC Biotech, Cantanhede, Portugal.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Herder', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Frithjof', 'Initials': 'F', 'LastName': 'Wickrath', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Bobrov', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Jong-Hee', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'John Griffith', 'Initials': 'JG', 'LastName': 'Jones', 'Affiliation': 'Centre for Neurosciences and Cell Biology, UC Biotech, Cantanhede, Portugal.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}]",JCI insight,['10.1172/jci.insight.134520']
2773,31268828,Myofibrillar protein synthesis and muscle hypertrophy individualized responses to systematically changing resistance training variables in trained young men.,"The manipulation of resistance training (RT) variables is used among athletes, recreational exercisers, and compromised populations (e.g., elderly) attempting to potentiate muscle hypertrophy. However, it is unknown whether an individual's inherent predisposition dictates the RT-induced muscle hypertrophic response. Resistance-trained young [26 (3) y] men ( n  = 20) performed 8 wk unilateral RT (2 times/wk), with 1 leg randomly assigned to a standard progressive RT [control (CON)] and the contralateral leg to a variable RT (VAR; modulating exercise load, volume, contraction type, and interset rest interval). The VAR leg completed all 4 RT variations every 2 wk. Bilateral vastus lateralis cross-sectional area (CSA) was measured, pre- and post-RT and acute integrated myofibrillar protein synthesis (MyoPS) rates were assessed at rest and over 48 h following the final RT session. Muscle CSA increase was similar between CON and VAR ( P  > 0.05), despite higher total training volume (TTV) in VAR ( P  < 0.05). The 0-48-h integrated MyoPS increase postexercise was slightly greater for VAR than CON ( P  < 0.05). All participants were considered ""responders"" to RT, although none benefited to a greater extent from a specific protocol. Between-subjects variability (MyoPS, 3.30%; CSA, 37.8%) was 40-fold greater than the intrasubject (between legs) variability (MyoPS, 0.08%; CSA, 0.9%). The higher TTV and greater MyoPS response in VAR did not translate to a greater muscle hypertrophic response. Manipulating common RT variables elicited similar muscle hypertrophy than a standard progressive RT program in trained young men. Intrinsic individual factors are key determinants of the MyoPS and change in muscle CSA compared with extrinsic manipulation of common RT variables. NEW & NOTEWORTHY  Systematically manipulating resistance training (RT) variables during RT augments the stimulation of myofibrillar protein synthesis (MyoPS) and training volume but fails to potentiate muscle hypertrophy compared with a standard progressive RT. Any modest further MyoPS increase and higher training volumes do not reflect in a greater hypertrophic response. Between-subject variability was 40-fold greater than the variability promoted by extrinsic manipulation of RT variables, indicating that individual intrinsic factors are stronger determinants of the hypertrophic response.",2019,"Muscle CSA increase was similar between CON and VAR (P>0.05), despite higher total training volume (TTV) in VAR (P<0.05).","['athletes, recreational exercisers and compromised populations (e.g., elderly', 'trained young men', 'Twenty resistance-trained young (26(3)y) men performed 8wk unilateral RT (2∙wk -1 ) with one leg randomly assigned to a']","['standard progressive-RT program', 'standard progressive RT (CON), and the contralateral leg to a variable RT (VAR, modulating exercise load, volume, contraction type and interset rest interval']","['Bilateral  vastus lateralis  cross-sectional area (CSA', 'MyoPS response', 'Muscle CSA increase', 'myofibrillar protein synthesis (MyoPS) rates', 'total training volume (TTV', 'muscle hypertrophic response']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}]",,0.016115,"Muscle CSA increase was similar between CON and VAR (P>0.05), despite higher total training volume (TTV) in VAR (P<0.05).","[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Damas', 'Affiliation': 'MUSCULAB-Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Vitor', 'Initials': 'V', 'LastName': 'Angleri', 'Affiliation': 'MUSCULAB-Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Oliver C', 'Initials': 'OC', 'LastName': 'Witard', 'Affiliation': ""Centre for Human and Applied Physiological Sciences, School of Basic and Medical Biosciences, Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ugrinowitsch', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Santanielo', 'Affiliation': 'MUSCULAB-Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Soligon', 'Affiliation': 'MUSCULAB-Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Luiz A R', 'Initials': 'LAR', 'LastName': 'Costa', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Manoel E', 'Initials': 'ME', 'LastName': 'Lixandrão', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Miguel S', 'Initials': 'MS', 'LastName': 'Conceição', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cleiton A', 'Initials': 'CA', 'LastName': 'Libardi', 'Affiliation': 'MUSCULAB-Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, São Carlos, Brazil.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00350.2019']
2774,32435011,Effects of Statin Plus Ezetimibe on Coronary Plaques in Acute Coronary Syndrome Patients with Diabetes Mellitus: Sub-Analysis of PRECISE-IVUS Trial.,"AIM


Coronary plaque regression is weak in acute coronary syndrome (ACS) patients with diabetes mellitus (DM). We evaluated whether dual lipid-lowering therapy (DLLT) with ezetimibe and atorvastatin attenuates coronary plaques in ACS patients with DM.
METHODS


The prospective, randomized controlled, multicenter PRECISE-IVUS (Plaque Regression with Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by Intravascular Ultrasound) trial assigned 246 patients undergoing percutaneous coronary intervention to DLLT or atorvastatin monotherapy and evaluated IVUS-derived changes in percent atheroma volume (ΔPAV), at baseline and 9-12-month follow-up, in 126 ACS cases, including 25 DM patients. The atorvastatin dose was up-titrated to achieve low-density lipoprotein cholesterol (LDL-C) ＜70 mg/dL.
RESULTS


In DM patients, the monotherapy group (n=13) and the DLLT group (n=12) showed a similar prevalence of coronary risks and baseline lipid profiles. During the study, the change in LDL-C level was similar between DM and non-DM patients. Compared with non-DM patients, DM patients showed weaker regression of ΔPAV by DLLT than those who underwent monotherapy (DM: -2.77±3.47% vs. -0.77±2.51%, P=0.11; non-DM: -2.01±3.36% vs. -0.08±2.66%, P=0.008). The change in LDL-C level was not correlated with ΔPAV in non-DM patients, but there was significant correlation between the change in LDL-C level and ΔPAV in DM patients (r=0.52, P=0.008).
CONCLUSIONS


ACS patients with DM showed weaker coronary plaque regression than their counterparts. A significant correlation between the change in LDL-C level and ΔPAV in DM patients suggested that more intensive lipid-lowering therapy is required in ACS patients with DM.",2020,"The change in LDL-C level was not correlated with ΔPAV in non-DM patients, but there was significant correlation between the change in LDL-C level and ΔPAV in DM patients (r=0.52, P=0.008).
","['acute coronary syndrome (ACS) patients with diabetes mellitus (DM', '246 patients undergoing percutaneous coronary intervention to DLLT or atorvastatin monotherapy and evaluated IVUS-derived changes in percent atheroma volume (ΔPAV), at baseline and 9-12-month follow-up, in 126 ACS cases, including 25 DM patients', 'Acute Coronary Syndrome Patients with Diabetes Mellitus', 'ACS patients with DM']","['atorvastatin', 'DLLT', 'Statin Plus Ezetimibe', 'dual lipid-lowering therapy (DLLT) with ezetimibe and atorvastatin', 'Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by Intravascular Ultrasound']","['coronary plaque regression', 'LDL-C level', 'Coronary Plaques', 'LDL-C level and ΔPAV', 'coronary risks and baseline lipid profiles']","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0264956', 'cui_str': 'Atheroma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",246.0,0.0567008,"The change in LDL-C level was not correlated with ΔPAV in non-DM patients, but there was significant correlation between the change in LDL-C level and ΔPAV in DM patients (r=0.52, P=0.008).
","[{'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Fujisue', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences and Center for Metabolic Regulation of Healthy Aging (CMHA), Kumamoto University.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Yamanaga', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences and Center for Metabolic Regulation of Healthy Aging (CMHA), Kumamoto University.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Nagamatsu', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences and Center for Metabolic Regulation of Healthy Aging (CMHA), Kumamoto University.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Shimomura', 'Affiliation': 'Department of Cardiovascular Medicine, Fukuoka Tokushukai Medical Center.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Division of Cardiology, Social Insurance Omuta Tenryo Hospital.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center.'}, {'ForeName': 'Sunao', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Interventional Cardiology Unit, New Tokyo Hospital.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Ishihara', 'Affiliation': 'Department of Cardiovascular and Renal Medicine, Hyogo College of Medicine.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Matsui', 'Affiliation': 'Department of Community Medicine, Kumamoto University.'}, {'ForeName': 'Naritsugu', 'Initials': 'N', 'LastName': 'Sakaino', 'Affiliation': 'Division of Cardiology, Amakusa Medical Center.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Miyazaki', 'Affiliation': 'Division of Cardiology, Shin-Beppu Hospital.'}, {'ForeName': 'Nobuyasu', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Cardiology, Miyazaki Prefectural Nobeoka Hospital.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Koide', 'Affiliation': 'Division of Cardiology, Japan Community Health care Organization Kumamoto General Hospital.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Matsumura', 'Affiliation': 'Division of Cardiology, Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital.'}, {'ForeName': 'Kazuteru', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Cardiology, National Hospital Organization Kumamoto Medical Center.'}, {'ForeName': 'Ryusuke', 'Initials': 'R', 'LastName': 'Tsunoda', 'Affiliation': 'Division of Cardiology, Japanese Red Cross Kumamoto Hospital.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Morikami', 'Affiliation': 'Division of Cardiology, Kumamoto City Hospital.'}, {'ForeName': 'Koushi', 'Initials': 'K', 'LastName': 'Matsuyama', 'Affiliation': 'Division of Cardiology, Social Insurance Omuta Tenryo Hospital.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Oshima', 'Affiliation': 'Division of Cardiology, Kumamoto Central Hospital.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences and Center for Metabolic Regulation of Healthy Aging (CMHA), Kumamoto University.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Izumiya', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences and Center for Metabolic Regulation of Healthy Aging (CMHA), Kumamoto University.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kaikita', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences and Center for Metabolic Regulation of Healthy Aging (CMHA), Kumamoto University.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Hokimoto', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences and Center for Metabolic Regulation of Healthy Aging (CMHA), Kumamoto University.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'National Cerebral and Cardiovascular Center.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Tsujita', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences and Center for Metabolic Regulation of Healthy Aging (CMHA), Kumamoto University.'}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.54726']
2775,32435018,[USEFULNESS OF RUPATADINE FOR PRURITUS OF PATIENTS WITH ATOPIC DERMATITIS].,"BACKGROUND


Histamine H1 receptor antagonists (antihistamines) are recommended as adjunctive therapy for atopic dermatitis (AD). However, their long-term usefulness and the effect of updosing have not been clarified.
PURPOSE


To analyzed the long-term usefulness and the effect of updosing of rupatadine, a second generation antihistamine, for patients with AD.
METHODS


Efficacy and safety of rupatadine were evaluated in 66 AD patients, including 50 patients with dose escalation by post hoc analysis of the phase III trial of rupatadine for Japanese patients with pruritus associated with skin diseases.
RESULTS


The mean score at baseline total pruritus score (TPS) was 4.682. It decreased to 3.885 at 2 weeks, and 2.376 at 52 weeks by rupatadine administration. The change (of one week after baseline TPS) was significant. Baseline TPS of dose escalation groups, either after 2 weeks or after week 4, were higher than those of 10mg maintenance dose cases, but no significant difference was shown in the change from baseline TPS among the groups at 52 weeks. The occurrence of adverse drug reactions and somnolence were observed in 19.7% and 15.2% of the subjects.
CONCLUSION


These results suggest the long-term usefulness of rupatadine for pruritus in AD.",2020,"The occurrence of adverse drug reactions and somnolence were observed in 19.7% and 15.2% of the subjects.
","['atopic dermatitis (AD', 'patients with AD', '66 AD patients, including 50 patients with dose escalation by post hoc analysis of the phase III trial of rupatadine for Japanese patients with pruritus associated with skin diseases']","['rupatadine', 'Histamine H1 receptor antagonists (antihistamines', 'rupatadine, a second generation antihistamine']","['occurrence of adverse drug reactions and somnolence', 'mean score at baseline total pruritus score (TPS']","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0534301', 'cui_str': 'rupatadine'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}]","[{'cui': 'C0534301', 'cui_str': 'rupatadine'}, {'cui': 'C0019592', 'cui_str': 'Histamine H1 receptor antagonist'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C1136312', 'cui_str': 'Second Generation H1 Antagonists'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033774', 'cui_str': 'Itching'}]",66.0,0.0566319,"The occurrence of adverse drug reactions and somnolence were observed in 19.7% and 15.2% of the subjects.
","[{'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Hide', 'Affiliation': 'Department of Dermatology, Graduate School of Biomedical and Health Sciences, Hiroshima University.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Hirata', 'Affiliation': 'Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation.'}, {'ForeName': 'Naruyasu', 'Initials': 'N', 'LastName': 'Komorita', 'Affiliation': 'Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Kubo', 'Affiliation': 'Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation.'}, {'ForeName': 'Takamasa', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Clinical Development & Regulatory Strategy Center, Teikoku Seiyaku CO LTD.'}, {'ForeName': 'Ayaka', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Clinical Development & Regulatory Strategy Center, Teikoku Seiyaku CO LTD.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Aoki', 'Affiliation': 'Clinical Development & Regulatory Strategy Center, Teikoku Seiyaku CO LTD.'}]",Arerugi = [Allergy],['10.15036/arerugi.69.174']
2776,31187653,Effect of Autologous Fibrin Glue on Lymphatic Drainage and Lymphocele Formation in Extended Bilateral Pelvic Lymphadenectomy in Robot-Assisted Radical Prostatectomy.,"Introduction:  Postoperative lymphatic drainage and lymphocele formation is a common seen complication after extended pelvic lymph node dissection (ePLND) in robot-assisted radical prostatectomy (RARP) operation. The aim of this study was to evaluate autologous fibrin glue as an additional treatment option to reduce the volume of lymphatic drainage and prevent lymphocele development.  Materials and Methods:  A total of 75 patients undergoing transperitoneal RARP with ePLND between January and July 2018 were enrolled in this study. Thirty-five patients who received autologous fibrin glue enrolled to study group, another 40 patients who did not receive to control group. Autologous fibrin glue was applied over the PLND areas. Age, body mass index (BMI), pathologic stages, and number of removed lymph nodes (LNs) were compared. The main endpoint was to compare postoperative lymphatic drainage volume and lymphocele formation rate between groups.  Results:  There was not statistically significant difference between the groups with respect to age, BMI, Gleason score, T-stage, and number of removed LNs. Autologous fibrin glue resulted in 50% (110 mL  vs  210 mL;  p  = 0.037) and 75% reduction of postoperative drainage volume (70 mL  vs  270 mL;  p  = < 0.0001) in study group than control group at postoperative 2nd and 3rd days, respectively. The total drainage volume was also 50% reduced in study group (277 mL  vs  577 mL;  p  = 0.004). The incidence of asymptomatic lymphocele was 20% ( n  = 7) and 37.5% ( n  = 15) in study and control groups, respectively ( p  = 0.112). One patient in control group developed symptomatic lymphocele. There were no immediate or late adverse effects in study group.  Conclusion:  Autologous fibrin glue application reduced postoperative lymphatic drainage, and also lymphocele formation rate after extended PLND in RARP operation.",2019,"Autologous fibrin glue resulted in 50% (110ml vs. 210ml; P = 0.037) and 75% reduction of postoperative drainage volume (70ml vs. 270ml; P = <0.0001) in study group than control group at postoperative 2nd and 3th days, respectively.","['with extended pelvic lymph node dissection between January - July 2018 were enrolled in this study', 'Extended Bilateral Pelvic Lymphadenectomy in Robot-Assisted Radical Prostatectomy', 'Thirty-five patients who received autologous fibrin glue enrolled to study group, another 40 patients who did not receive to control group', '75 patients undergoing']","['Autologous fibrin glue', 'autologous fibrin glue', 'Autologous fibrin glue application', 'robot-assisted radical prostatectomy (RARP) operation', 'Autologous Fibrin Glue', 'transperitoneal robot-assisted radical prostatectomy']","['Lymphatic Drainage and Lymphocele Formation', 'volume of lymphatic drainage and prevent lymphocele development', 'postoperative lymphatic drainage volume and lymphocele formation rate', 'incidence of asymptomatic lymphocele', 'postoperative lymphatic drainage', 'lymphocele formation rate', 'total drainage volume', 'postoperative drainage volume', 'symptomatic lymphocele', 'body-mass index, Gleason score, T-stage and number of removed lymph nodes', 'immediate or late adverse effects']","[{'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy (procedure)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0205501', 'cui_str': 'Transperitoneal approach (qualifier value)'}]","[{'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0024248', 'cui_str': 'Lymphatic Cyst'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3203027', 'cui_str': 'Gleason score (observable entity)'}, {'cui': 'C0475455', 'cui_str': 'T category'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",75.0,0.052078,"Autologous fibrin glue resulted in 50% (110ml vs. 210ml; P = 0.037) and 75% reduction of postoperative drainage volume (70ml vs. 270ml; P = <0.0001) in study group than control group at postoperative 2nd and 3th days, respectively.","[{'ForeName': 'Asgar', 'Initials': 'A', 'LastName': 'Garayev', 'Affiliation': 'Department of Urology, Istanbul Bilim University, Istanbul, Turkey.'}, {'ForeName': 'Ömer', 'Initials': 'Ö', 'LastName': 'Aytaç', 'Affiliation': 'Department of Urology, Istanbul Florence Nightingale Hospital, Istanbul, Turkey.'}, {'ForeName': 'Hasan Hüseyin', 'Initials': 'HH', 'LastName': 'Tavukcu', 'Affiliation': 'Department of Urology, Istanbul Florence Nightingale Hospital, Istanbul, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Atug', 'Affiliation': 'Department of Urology, Istanbul Bilim University, Istanbul, Turkey.'}]",Journal of endourology,['10.1089/end.2018.0853']
2777,31219772,Effects of caffeine and sex on muscle performance and delayed-onset muscle soreness after exercise-induced muscle damage: a double-blind randomized trial.,"The present study aims to investigate effects of caffeine ingestion and sex difference on muscle performance, delayed-onset muscle soreness (DOMS), and various biomarkers under exercise-induced muscle damage (EIMD). Twenty (10 male and 10 female) healthy elite college athletes were recruited. Participants ingested either caffeine (6 mg/kg) or a placebo in a randomized, double-blind, and counterbalanced fashion at 24 and 48 h following EIMD. Muscle performance, DOMS, and blood samples were taken an hour before and an hour after supplementation. Caffeine ingestion restored impaired maximal voluntary isometric contractions (MVIC: 10.2%; MVIC post : 7.2%, both  P  < 0.05) during EIMD across both sexes. Following caffeine ingestion during MVIC, while affected by EIMD, an interaction was found in DOMS and serum K +  (both  P  < 0.05), with males showing greater attenuation (21.5 and 16.9%, respectively) compared with females (4.6 and 1.3%, respectively). DOMS demonstrated an inverse correlation with MVIC after caffeine ingestion both overall and among male athletes ( r =  -0.34 and -0.54, respectively;  P  < 0.05) but not among female athletes ( r =  -0.11;  P  > 0.05) under EIMD. In addition, caffeine ingestion increased postexercise serum glucose and lactate concentrations across both sexes (both  P  < 0.05). This is the first study to show that male athletes, compared with female athletes, experience a greater reduction in DOMS during enhanced MVIC when caffeine was consumed, suggesting men might receive greater ergogenic effects from caffeine when affected by EIMD. Furthermore, caffeine ingestion was able to restore impaired muscle power among elite collegiate athletes across both sexes. NEW & NOTEWORTHY  Exercise-induced muscle damage (EIMD) reduces anaerobic/aerobic performance and increases delayed-onset muscle soreness (DOMS) during exercise. We show that acute caffeine supplementation at a dosage of 6 mg/kg seems to facilitate recovery of anaerobic muscle power and attenuate DOMS after EIMD across both sexes. Furthermore, male athletes, compared with female athletes, when caffeine was prescribed, experience a greater reduction in DOMS with better restoration of impaired maximal voluntary isometric contractions. This suggests that male athletes might benefit from the ergogenic effect of acute caffeine supplementation after the onset of EIMD.",2019,"Caffeine ingestion restored impaired maximal voluntary isometric contractions (MVIC: 10.2%; MVIC post : 7.2%) (both,  p <.05) during EIMD across both sexes.","['Twenty (10 male and 10 female) healthy elite college athletes', 'male athletes']","['placebo', 'caffeine', 'Caffeine ingestion', 'caffeine and sex', 'caffeine ingestion']","['muscle performance and delayed onset muscle soreness', 'post-exercise serum glucose, and lowered lactate concentrations', 'maximal voluntary isometric contractions', 'Muscle performance, DOMS and blood samples', 'muscle performance, delayed onset muscle soreness (DOMS) and various biomarkers under exercise-induced muscle damage (EIMD', 'DOMS and serum K ']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.206088,"Caffeine ingestion restored impaired maximal voluntary isometric contractions (MVIC: 10.2%; MVIC post : 7.2%) (both,  p <.05) during EIMD across both sexes.","[{'ForeName': 'Hou-Yu', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Education Center for Humanities and Social Sciences, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Tung', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Han', 'Initials': 'HH', 'LastName': 'Chao', 'Affiliation': 'Department of Athletics, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Ho-Seng', 'Initials': 'HS', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.01108.2018']
2778,32127350,Impact of Social Support on Colorectal Cancer Screening among Adult Hispanics/Latinos: A Randomized Community-based Study in Central Pennsylvania.,"In the United States, the five-year survival rate of colorectal cancer for Latinos is lower than it is for White, non-Latinos. Differences in survival are due, in part, to Latinos being diagnosed at a later stage. An ethnic gap in the use of colorectal cancer screening contributes to the difference in survival. We developed, implemented, and evaluated a targeted colorectal cancer screening intervention to increase colorectal cancer screening uptake by sex, ethnicity, and geography. We measured actual colorectal cancer screening uptake in both arms as a method to determine completion rates. We used a randomized, community-based, participatory design to test the impact of social support (intervention) on completion of a provider-recommended, take-home fecal immunochemical test (FIT) kit screening test among average-risk, urban, and rural Pennsylvania Latino adults age 50 and older not currently adherent to national colorectal cancer screening guidelines ( n  = 264). Participants in each arm attended a community-based educational program offered at eight sites. Among the 264 participants, 154 (58%) returned a completed usable FIT kit screening test. A higher return rate was observed among participants in the social support arm (66.0%) compared with the control (47.2%). Participants in the social support arm were statistically significant 2.67 times as likely to return a completed FIT kit. Of these, 27 (17.5%) had a positive FIT kit screening test result. The results of this study suggest that social support is an effective method to increase colorectal cancer screening rates among Latinos. Future studies should examine dissemination and implementation of community-based strategies among Latinos that include social support.",2020,A higher return rate was observed among participants in the social support arm (66.0%) compared to the control (47.2%).,"['average-risk, urban and rural Pennsylvania Latino adults age 50 and older not currently adherent to national CRC screening guidelines (n=264', '264 participants, 154 (58%) returned a completed usable FIT kit screening test', 'Latinos', 'Adult Hispanics']","['social support (intervention', 'Social Support', 'CRC screening intervention', 'provider-recommended, take-home fecal immunochemical test (FIT) kit screening test']","['survival', 'CRC screening rates', 'return rate', 'actual CRC screening uptake']","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}]","[{'cui': 'C0037438'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",264.0,0.0226142,A higher return rate was observed among participants in the social support arm (66.0%) compared to the control (47.2%).,"[{'ForeName': 'Oralia G', 'Initials': 'OG', 'LastName': 'Dominic', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania. Dr.Oralia@gmail.com.'}, {'ForeName': 'Vern', 'Initials': 'V', 'LastName': 'Chinchilli', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Wasserman', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Curry', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Kambic', 'Affiliation': 'Kambic Family Clinic, Steelton, Pennsylvania.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Caicedo', 'Affiliation': 'Pinnacle Health System, Harrisburg, Pennsylvania.'}, {'ForeName': 'Amelie G', 'Initials': 'AG', 'LastName': 'Ramirez', 'Affiliation': 'Institute for Health Promotion Research, Health Disparities Research, UT Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ochoa', 'Affiliation': 'Department of Spanish, Italian and Portuguese, College of Health and Human Development, The Pennsylvania State University, State College, Pennsylvania.'}, {'ForeName': 'Eugene J', 'Initials': 'EJ', 'LastName': 'Lengerich', 'Affiliation': 'Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0333']
2779,32435057,"Fatigue, quality of life and physical fitness following an exercise intervention in multiple myeloma survivors (MASCOT): an exploratory randomised Phase 2 trial utilising a modified Zelen design.","BACKGROUND


Exercise may improve fatigue in multiple myeloma survivors, but trial evidence is limited, and exercise may be perceived as risky in this older patient group with osteolytic bone destruction.
METHODS


In this Phase 2 Zelen trial, multiple myeloma survivors who had completed treatment at least 6 weeks ago, or were on maintenance only, were enrolled in a cohort study and randomly assigned to usual care or a 6-month exercise programme of tailored aerobic and resistance training. Outcome assessors and usual care participants were masked. The primary outcome was the FACIT-F fatigue score with higher scores denoting less fatigue.
RESULTS


During 2014-2016, 131 participants were randomised 3:1 to intervention (n = 89) or usual care (n = 42) to allow for patients declining allocation to the exercise arm. There was no difference between groups in fatigue at 3 months (between-group mean difference: 1.6 [95% CI: -1.1-4.3]) or 6 months (0.3 [95% CI: -2.6-3.1]). Muscle strength improved at 3 months (8.4 kg [95% CI: 0.5-16.3]) and 6 months (10.8 kg [95% CI: 1.2-20.5]). Using per-protocol analysis, cardiovascular fitness improved at 3 months (+1.2 ml/kg/min [95% CI: 0.3-3.7]). In participants with clinical fatigue (n = 17), there was a trend towards less fatigue with exercise over 6 months (6.3 [95% CI: -0.6-13.3]). There were no serious adverse events.
CONCLUSIONS


Exercise appeared safe and improved muscle strength and cardiovascular fitness, but benefits in fatigue appeared limited to participants with clinical fatigue at baseline. Future studies should focus on patients with clinical fatigue.
CLINICAL TRIAL REGISTRATION


The study was registered with ISRCTN (38480455) and is completed.",2020,Muscle strength improved at 3 months (8.4 kg [95% CI: 0.5-16.3]) and 6 months (10.8 kg [95% CI: 1.2-20.5]).,"['older patient group with osteolytic bone destruction', 'During 2014-2016, 131 participants', 'patients with clinical fatigue', 'multiple myeloma survivors (MASCOT', 'multiple myeloma survivors who had completed treatment at least 6 weeks ago, or were on maintenance only', 'multiple myeloma survivors']","['usual care or a 6-month exercise programme of tailored aerobic and resistance training', 'exercise intervention', 'usual care']","['Muscle strength', 'fatigue', 'cardiovascular fitness', 'FACIT-F fatigue score', 'Fatigue, quality of life and physical fitness', 'fatigue with exercise', 'safe and improved muscle strength and cardiovascular fitness']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0238790', 'cui_str': 'Bone destruction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003023', 'cui_str': 'Angola'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",131.0,0.234799,Muscle strength improved at 3 months (8.4 kg [95% CI: 0.5-16.3]) and 6 months (10.8 kg [95% CI: 1.2-20.5]).,"[{'ForeName': 'Dimitrios A', 'Initials': 'DA', 'LastName': 'Koutoukidis', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Land', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Heinrich', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'McCourt', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Beeken', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Philpott', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Dunnya', 'Initials': 'D', 'LastName': 'DeSilva', 'Affiliation': 'Cancer Institute, University College London, London, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rismani', 'Affiliation': 'Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Rabin', 'Affiliation': 'Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Popat', 'Affiliation': 'Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Charalampia', 'Initials': 'C', 'LastName': 'Kyriakou', 'Affiliation': 'Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Papanikolaou', 'Affiliation': 'Department of Haematology, Lister Hospital, Stevenage, UK.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Mehta', 'Affiliation': 'Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Paton', 'Affiliation': 'Institute of Sport, Exercise and Health, London, UK.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Fisher', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Kwee L', 'Initials': 'KL', 'LastName': 'Yong', 'Affiliation': 'Cancer Institute, University College London, London, UK. kwee.yong@ucl.ac.uk.'}]",British journal of cancer,['10.1038/s41416-020-0866-y']
2780,32435196,Investigation of the Cellular Pharmacological Mechanism and Clinical Evidence of the Multi-Herbal Antiarrhythmic Chinese Medicine Xin Su Ning.,"Xin Su Ning (XSN), a China patented and certified multi-herbal medicine, has been available in China since 2005 for treating cardiac ventricular arrhythmia including arrhythmia induced by ischemic heart diseases and viral myocarditis, without adverse reactions being reported. It is vitally important to discover pharmacologically how XSN as a multicomponent medicine exerts its clinical efficacy, and whether the therapeutic effect of XSN can be verified by standard clinical trial studies. In this paper we report our discoveries in a cellular electrophysiological study and in a three-armed, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Conventional electrophysiological techniques were used to study the cellular antiarrhythmic mechanism of XSN. Data was then modeled with computational simulation of human action potential (AP) of the cardiac ventricular myocytes. The clinical trial was conducted with a total of 861 eligible participants randomly assigned in a ratio of 2:2:1 to receive XSN, mexiletine, or the placebo for 4 weeks. The primary and secondary endpoint was the change of premature ventricular contraction (PVC) counts and PVC-related symptoms, respectively. This trial was registered in the Chinese Clinical Trial Register Center (ChiCTR-TRC-14004180). We found that XSN prolonged AP duration of the ventricular myocytes in a dose-dependent, reversible manner and blocked potassium channels. Patients in XSN group exhibited significant total effective responses in the reduction of PVCs compared to those in the placebo group (65.85% vs. 27.27%, P < 0.0001). No severe adverse effects attributable to XSN were observed. In conclusion, XSN is an effective multicomponent antiarrhythmic medicine to treat PVC without adverse effect in patients, which is convincingly supported by its class I & III pharmacological antiarrhythmic mechanism of blocking hERG potassium channels and hNaV1.5 sodium channel reported in our earlier publication and prolongs AP duration both in ventricular myocytes and with computational simulation of human AP presented in this report.",2020,"Patients in XSN group exhibited significant total effective responses in the reduction of PVCs compared to those in the placebo group (65.85% vs. 27.27%, P < 0.0001).",['861 eligible participants randomly assigned in a ratio of 2:2:1 to receive'],"['Xin Su Ning (XSN', 'XSN, mexiletine, or the placebo', 'XSN', 'placebo']","['reduction of PVCs', 'XSN prolonged AP duration of the ventricular myocytes', 'change of premature ventricular contraction (PVC) counts and PVC-related symptoms, respectively', 'total effective responses']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0025887', 'cui_str': 'Mexiletine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0001272', 'cui_str': 'Action Potentials'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0596981', 'cui_str': 'Myocytes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",861.0,0.297639,"Patients in XSN group exhibited significant total effective responses in the reduction of PVCs compared to those in the placebo group (65.85% vs. 27.27%, P < 0.0001).","[{'ForeName': 'Yu-Ling', 'Initials': 'YL', 'LastName': 'Ma', 'Affiliation': 'Oxford Chinese Medicine Research Centre & Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Rou-Mu', 'Initials': 'RM', 'LastName': 'Hu', 'Affiliation': 'Heart Center & Beijing Key Laboratory of Hypertension, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xinchun', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Heart Center & Beijing Key Laboratory of Hypertension, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Taiyi', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Oxford Chinese Medicine Research Centre & Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Penelope J', 'Initials': 'PJ', 'LastName': 'Noble', 'Affiliation': 'Oxford Chinese Medicine Research Centre & Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wilkins', 'Affiliation': 'Oxford Chinese Medicine Research Centre & Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Ellory', 'Affiliation': 'Oxford Chinese Medicine Research Centre & Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Carr', 'Affiliation': 'Oxford Chinese Medicine Research Centre & Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Noble', 'Affiliation': 'Oxford Chinese Medicine Research Centre & Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jiefu', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology, Beijing, China.'}, {'ForeName': 'Weixing', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing, China.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Hongde', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiovascular Diseases, West China Hospital, School of Clinic Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Geriatrics Department, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Clinical Departments of Cardiology, Dongfang Hospital Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': ""Department of Cardiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Jingyuan', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Department of Cardiology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Xiaochang', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Xiyuan Hospital CACMS, Beijing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Department of Cardiology, the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Huanlin', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiology, Hengyang Hospital of Traditional Chinese Medicine, Hengyang, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Tianjin Hospital of ITCWM Nankai Hospital, Tianjin, China.'}, {'ForeName': 'Wanli', 'Initials': 'W', 'LastName': 'Gu', 'Affiliation': ""Department of Traditional Chinese Medicine, Liaocheng People's Hospital, Liaocheng, China.""}]",Frontiers in pharmacology,['10.3389/fphar.2020.00600']
2781,31387410,Safety and efficacy of fulranumab in osteoarthritis of the hip and knee: results from four early terminated phase III randomized studies.,"Objective:  To evaluate the safety and efficacy of fulranumab as adjunct or monotherapy in patients with knee or hip pain related to moderate-to-severe osteoarthritis. Methods:  Osteoarthritic patients (aged ≥18 years) from four phase 3 randomized, double-blind (DB), placebo-controlled studies were randomized to receive placebo, fulranumab 1 mg every 4 weeks (Q4wk), or 3 mg Q4wk in 16-week DB phase, followed by a 52-week post-treatment follow-up phase. Safety assessments included treatment-emergent adverse events (TEAEs), and neurological, sympathetic, and joint-related events of interest. Efficacy assessments included pain and physical function sub-scales of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores. Results:  Of 245 patients from the ITT set (median age = 64 years; 62% women), 84 (34%) completed the DB phase; the majority of discontinuations (57%) were due to early study termination. In the DB phase, the incidence of TEAEs in fulranumab 3 mg (57.8%) and 1 mg (56.8%) was similar to placebo (56.8%). Two events adjudicated as joint-related events of interest include rapidly progressive osteoarthritis and fracture of unknown etiology. There were no new neurological TEAEs. Fulranumab showed evidence of efficacy in improving pain and physical function based on WOMAC sub-scale scores. Due to premature study termination, the number of patients enrolled were too small to make any definitive efficacy claims. Conclusions:  Treatment with fulranumab was generally tolerated with no new safety signals. Within the limited sample analyzed, fulranumab showed evidence of improvement of pain and function in patients with moderate-to-severe osteoarthritis who had failed prior therapy and were candidates for joint replacement surgery. Clinical trial registration numbers:  NCT02336685; NCT02336698; NCT02289716; NCT02301234KEY POINTSFulranumab as adjuvant or monotherapy was well tolerated with no new safety signalsFulranumab demonstrated evidence suggestive of efficacy in osteoarthritic pain of hip and kneeFulranumab demonstrated evidence suggestive of improvement of pain and physical function in osteoarthritis.",2019,Fulranumab as adjuvant or monotherapy was well tolerated with no new safety signals Fulranumab demonstrated evidence suggestive of efficacy in osteoarthritic pain of hip and knee Fulranumab demonstrated evidence suggestive of improvement of pain and physical function in osteoarthritis.,"['245 patients from the ITT set (median age, 64 years; women, 62%), 84 (34%) completed DB phase', 'patients with moderate-to-severe osteoarthritis who had failed prior therapy and were candidates for joint replacement surgery', 'osteoarthritis of the hip and knee', 'Osteoarthritic patients (aged ≥18 years', 'patients with knee or hip pain related to moderate-to-severe osteoarthritis']","['Fulranumab as adjuvant or monotherapy', 'placebo', 'Fulranumab', 'monotherapy', 'placebo, fulranumab', 'fulranumab']","['pain and physical function based on WOMAC subscales scores', 'pain and physical function', 'Safety and efficacy', 'pain and function', 'pain and physical function subscales of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores', 'treatment-emergent adverse events (TEAEs), and neurological, sympathetic and joint-related events of interest', 'safety and efficacy']","[{'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0185317', 'cui_str': 'Joint Replacement'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0019559', 'cui_str': 'Hip pain (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C2981231', 'cui_str': 'fulranumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",245.0,0.0675394,Fulranumab as adjuvant or monotherapy was well tolerated with no new safety signals Fulranumab demonstrated evidence suggestive of efficacy in osteoarthritic pain of hip and knee Fulranumab demonstrated evidence suggestive of improvement of pain and physical function in osteoarthritis.,"[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Kelly', 'Affiliation': 'Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Panna', 'Initials': 'P', 'LastName': 'Sanga', 'Affiliation': 'Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Zaki', 'Affiliation': 'Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Haeussler', 'Affiliation': 'Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Louie', 'Affiliation': 'Janssen Research and Development, LLC, Fremont, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thipphawong', 'Affiliation': 'Janssen Research and Development, LLC, Fremont, CA, USA.'}]",Current medical research and opinion,['10.1080/03007995.2019.1653068']
2782,16881913,Mother's reactions to a skills-based breastfeeding promotion intervention.,"We interviewed women who participated in a breast-feeding promotion intervention study about whether and how participation affected their infant feeding choices, and if they would recommend such an intervention to others. The larger study, a randomized controlled trial (RCT) of an individualized, pre- and post-natal lactation consultant (LC) intervention, enrolled 382 low-income primarily Black and Hispanic women in New York City. Twenty-one women completed qualitative exit interviews for this study (11 from the Intervention group and 10 Controls). Several of the Controls stated that the post-partum study interviews were a source of support, and made them more conscious of how they fed their infant. The Intervention Group was asked about contacts with the study 'Mother-Baby specialist' (i.e. LC), including what was and wasn't helpful. The Intervention Group participants described the Mother-Baby Specialist as key in their decision to initiate and maintain breastfeeding. They credit her direct skills and positive reinforcement with their confidence and perseverance to breastfeed. The success of the intervention is attributed to technical assistance from a trained lactation consultant within the context of a relationship built on encouragement, guidance and support.",2006,"We interviewed women who participated in a breast-feeding promotion intervention study about whether and how participation affected their infant feeding choices, and if they would recommend such an intervention to others.",['enrolled 382 low-income primarily Black and Hispanic women in New York City'],"['individualized, pre- and post-natal lactation consultant (LC) intervention', 'Mother-Baby Specialist as key in their decision to initiate and maintain breastfeeding']",[],"[{'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0454729', 'cui_str': 'Natal (geographic location)'}, {'cui': 'C0558270', 'cui_str': 'Lactation consultant (occupation)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],382.0,0.0391527,"We interviewed women who participated in a breast-feeding promotion intervention study about whether and how participation affected their infant feeding choices, and if they would recommend such an intervention to others.","[{'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Memmott', 'Affiliation': 'Division of Research on Children, Youth and Families, Childrens Hospital Los Angeles, 4650 Sunset Blvd, Mailstop 30, CA 90027, USA. mmemmott@chla.use.edu'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Bonuck', 'Affiliation': ''}]",Maternal & child nutrition,[]
2783,16881929,Multi-micronutrient Sprinkles including a low dose of iron provided as microencapsulated ferrous fumarate improves haematologic indices in anaemic children: a randomized clinical trial.,"Home-fortification of complementary foods with micronutrients (including iron) as Sprinkles is a new strategy to control iron deficiency and anaemia in developing countries. However, the most effective dose and form of iron is not known. The purpose of this study was to compare the efficacy of various doses (12.5, 20 or 30 mg) and treatment methods (multi-micronutrient Sprinkles vs. ferrous sulphate drops) on haemoglobin (Hb) concentration after 8 weeks of treatment in anaemic children. In total, 133 anaemic Ghanaian children (Hb 70-99 g L(-1)) aged 6-18 months were randomly assigned to one of five daily interventions for 8 weeks. Out of the five interventions, four used Sprinkles, and one used iron drops. Of the four Sprinkles groups, three included 12.5, 20 or 30 mg of iron as ferrous fumarate, and one included 20 mg of iron as ferric pyrophosphate. The iron drops group included 12.5 mg of iron as liquid ferrous sulphate. Hb concentrations were measured at baseline, week 3 and week 8. The primary outcome measure was Hb concentration at 8 weeks after treatment. We compared differences in Hb and ferritin concentrations and prevalence of iron deficiency anaemia (Hb < 100 g L(-1) and soluble transferrin receptor concentrations >8.5 mg L(-1)) from baseline to 8 weeks within and between groups. Adherence and reporting of side effects (staining of the teeth, ease of use, diarrhoea and darkening of stools) were compared between groups. Mean change in Hb was 1.4 g L(-1) (SD = 1.8) (P = 0.0001). Change in Hb concentrations from baseline to 8 weeks was significant in all groups (P = 0.0001-0.0007), with no differences across groups. Geometric means of serum ferritin varied from 18.6 to 44.0 microg L(-1) at baseline. At week 8, these means were in the interval of 48.0-78.3 microg L(-1), with no group differences. Prevalence of iron deficiency anaemia decreased significantly from baseline to 8 weeks in all groups with the exception of the iron drops group, with no group differences. Adherence was lower in the drops group (64%) as compared with Sprinkles groups (84%). Greater staining of the teeth and less ease of use were reported in the drops group as compared with Sprinkles groups. A dose as low as 12.5 mg of iron as ferrous fumarate when provided as Sprinkles may be effective in anaemic children.",2006,Greater staining of the teeth and less ease of use were reported in the drops group as compared with Sprinkles groups.,"['anaemic children', '133 anaemic Ghanaian children (Hb 70-99 g L(-1)) aged 6-18 months']","['Home-fortification of complementary foods with micronutrients (including iron', 'iron as ferrous fumarate, and one included 20 mg of iron as ferric pyrophosphate', 'treatment methods (multi-micronutrient Sprinkles vs. ferrous sulphate drops', 'iron as liquid ferrous sulphate']","['Geometric means of serum ferritin', 'haemoglobin (Hb) concentration', 'haematologic indices', 'Hb concentrations', 'Hb concentration', 'Change in Hb concentrations', 'Adherence and reporting of side effects (staining of the teeth, ease of use, diarrhoea and darkening of stools', 'Hb and ferritin concentrations and prevalence of iron deficiency anaemia', 'Adherence', 'Prevalence of iron deficiency anaemia']","[{'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0337834', 'cui_str': 'Ghanaians (ethnic group)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0060276', 'cui_str': 'Ferrous fumarate'}, {'cui': 'C0117541', 'cui_str': 'ferric pyrophosphate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1720266', 'cui_str': 'Sprinkle'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}]",133.0,0.23396,Greater staining of the teeth and less ease of use were reported in the drops group as compared with Sprinkles groups.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Christofides', 'Affiliation': 'Division of Gastroenterology and Nutrition, The Hospital for Sick Children, Toronto and Programs in Metabolism and Integrative Biology, Research Institute, The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Kwaku Poku', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Schauer', 'Affiliation': ''}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Sharieff', 'Affiliation': ''}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Owusu-Agyei', 'Affiliation': ''}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Zlotkin', 'Affiliation': ''}]",Maternal & child nutrition,[]
2784,32435279,The effect of omega-3 and vitamin D co-supplementation on glycemic control and lipid profiles in reproductive-aged women with pre-diabetes and hypovitaminosis D: a randomized controlled trial.,"Background


Prediabetes can predispose the individual to type 2 diabetes in the long-term. The present study was conducted to determine the effectiveness of vitamin D and omega-3 co-supplementation on glycemic control and serum lipid profiles in women of reproductive age with prediabetes and hypovitaminosis D.
Methods


The present factorial, triple-blind, clinical trial was conducted on 168 women of reproductive age with prediabetes and hypovitaminosis D. The participants were assigned to four groups based on block randomization method: the placebo group received omega-3 and vitamin D placebos; the omega-3 group took omega-3 supplements and vitamin D placebos; the vitamin D group received omega-3 placebos and vitamin D supplements and the co-supplementation group. The groups received every 2 weeks 50,000 IU pearls of vitamin D and twice-daily doses of 1000-mg omega-3 tablets or placebos for 8 weeks. Dietary intake, physical activity, anthropometric indices and blood biochemical tests were measured at the beginning and end of the study. Analysis was performed using two-way mixed ANOVA.
Results


A significant reduction was observed in fasting glucose, insulin, homeostasis model assessment-beta cell function, weight and waist circumference in the co-supplementation group compared to the other three groups (P < 0.05). Moreover, high-density lipoprotein-cholesterol levels increased significantly in the co-supplementation group compared to the other three groups (P < 0.05). Despite the fact that homeostasis model assessment-insulin resistance, total cholesterol, triglyceride and low-density lipoprotein-cholesterol levels decreased after intervention in the co-supplementation group, there was no significant difference between the groups in these outcomes.
Conclusion


Vitamin D and omega-3 co-supplementation improved fasting serum glucose, insulin, high-density lipoprotein-cholesterol level, homeostasis model assessment-beta cell function, weight and waist circumference in women of reproductive age with prediabetes and hypovitaminosis D. This co-supplementation can therefore be recommended for glycemic control in these women. Trial registration  Iranian Registry of Clinical Trials Code: IRCT20100130003226N17. Registered on 9 Feb. 2019.",2020,"A significant reduction was observed in fasting glucose, insulin, homeostasis model assessment-beta cell function, weight and waist circumference in the co-supplementation group compared to the other three groups (P < 0.05).","['women of reproductive age with prediabetes and hypovitaminosis D', 'women of reproductive age with prediabetes and hypovitaminosis D.\nMethods', 'reproductive-aged women with pre-diabetes and hypovitaminosis D', '168 women of reproductive age with prediabetes and hypovitaminosis D']","['Vitamin D and omega-3 co-supplementation', 'vitamin D and omega-3 co-supplementation', 'omega-3 and vitamin D placebos; the omega-3 group took omega-3 supplements and vitamin D placebos; the vitamin D group received omega-3 placebos and vitamin D supplements and the co-supplementation group', 'omega-3 and vitamin D co-supplementation', 'vitamin D and twice-daily doses of 1000-mg omega-3 tablets or placebos', 'placebo']","['glycemic control and serum lipid profiles', 'high-density lipoprotein-cholesterol levels', 'fasting glucose, insulin, homeostasis model assessment-beta cell function, weight and waist circumference', 'glycemic control and lipid profiles', 'Dietary intake, physical activity, anthropometric indices and blood biochemical tests', 'fasting serum glucose, insulin, high-density lipoprotein-cholesterol level, homeostasis model assessment-beta cell function, weight and waist circumference', 'homeostasis model assessment-insulin resistance, total cholesterol, triglyceride and low-density lipoprotein-cholesterol levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0035579', 'cui_str': 'Rickets'}, {'cui': 'C0376286', 'cui_str': 'Avitaminosis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4319556', 'cui_str': '168'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}]",168.0,0.189887,"A significant reduction was observed in fasting glucose, insulin, homeostasis model assessment-beta cell function, weight and waist circumference in the co-supplementation group compared to the other three groups (P < 0.05).","[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Rajabi-Naeeni', 'Affiliation': '1Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Student Research Committee, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahrokh', 'Initials': 'M', 'LastName': 'Dolatian', 'Affiliation': '2Midwifery and Reproductive Health Research Center, Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Qorbani', 'Affiliation': '3Non-communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Amir Abbas', 'Initials': 'AA', 'LastName': 'Vaezi', 'Affiliation': '5Department of Internal Medicine, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran.'}]",Diabetology & metabolic syndrome,['10.1186/s13098-020-00549-9']
2785,31318613,Local exercise does not prevent the aortic stiffening response to acute prolonged sitting: a randomized crossover trial.,"Prolonged sitting has been shown to promote endothelial dysfunction in the lower legs. Furthermore, it has been reported that simple sitting-interruption strategies, including calf raises, prevent leg endothelial dysfunction. However, it is unclear whether prolonged sitting affects central cardiovascular health, or whether simple sitting-interruption strategies prevent impaired central cardiovascular health. This study sought to answer two questions: in young, healthy adults  1 ) does prolonged sitting (3 h) lead to increased aortic stiffness, and  2 ) do intermittent calf raise exercises to prevent pooling prevent aortic stiffening. Twenty young, healthy participants (21.7 ± 2.5 yr, 70% female, 25.5 ± 6.1 kg/m 2 ) were randomized to 3 h of sitting with (CALF) or without (CON) 10 calf raises every 10 min. Aortic stiffening [carotid-femoral pulse wave velocity (PWV)] was measured in the supine position pre- and post-sitting. Venous pooling during sitting was estimated with total hemoglobin (tHB) concentration using near-infrared spectroscopy. There were no condition × time interactions. Following 3 h of sitting, PWV significantly increased (0.30 ± 0.46 m/s,  P  < 0.001). There was no condition effect for PWV ( P  = 0.694), indicating the intermittent calf rises did not preserve central cardiovascular health. tHb was not significantly affected by sitting ( P  = 0.446) but was 1.9 μM higher for CON versus CALF ( P  = 0.106). Sitting increases aortic stiffness in young, healthy individuals, a process that may be influenced by lower extremity blood pooling. Calf raises, which have been reported to preserve vascular function in the legs, do not appear to provide sufficient stimulus for maintaining central cardiovascular health. NEW & NOTEWORTHY  Although simple strategies, such as fidgeting or calf raises, are sufficient for preserving vascular function in the legs, data from the current study indicate that such strategies are not sufficient for maintaining central cardiovascular health, which is linked to cardiovascular disease.",2019,"tHb was not significantly affected by sitting (p=0.446) but was 1.9 μM higher for CON vs. CALF (p=0.106).
","['young, healthy individuals', 'young, healthy adults (i', 'Twenty young, healthy participants (21.7±2.5 y, 70% F, 25.5±6.1 kg/m 2 ']","['CON vs. CALF', 'Sitting', 'sitting with (CALF) or without (CON) 10 calf raises every 10 min']","['central cardiovascular health', 'Aortic stiffening (carotid-femoral pulse wave velocity, PWV', 'total hemoglobin (tHB) concentration', 'condition x time interactions', 'aortic stiffness']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}]",20.0,0.0489022,"tHb was not significantly affected by sitting (p=0.446) but was 1.9 μM higher for CON vs. CALF (p=0.106).
","[{'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Evans', 'Affiliation': 'Department of Exercise and Sport Science, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Stoner', 'Affiliation': 'Department of Exercise and Sport Science, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Willey', 'Affiliation': 'Department of Exercise and Sport Science, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kelsch', 'Affiliation': 'Department of Exercise and Sport Science, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Credeur', 'Affiliation': 'School of Kinesiology and Nutrition, The University of Southern Mississippi, Hattiesburg, Mississippi.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Hanson', 'Affiliation': 'Department of Exercise and Sport Science, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00318.2019']
2786,31318614,Characterization of performance fatigability during a self-paced exercise.,"Pacing during a high-intensity cycling time trial (TT) appears to prevent premature task failure, but the performance fatigability during a self-paced exercise is currently unknown. Therefore, the current study characterized the time course of performance fatigability during a 4-km TT. Eleven male cyclists performed three separated TTs in a crossover, counterbalanced design. The TTs lasted until the end of the fast-start (FS; 600 ± 205 m), even-pace (EP; 3,600 ± 190 m), and end-spurt (ES; 4,000 m) phases. Performance fatigability was characterized by using isometric maximal voluntary contractions (IMVCs), whereas the muscle activation [i.e., voluntary activation (VA)] and contractile function of knee extensors [e.g., peak torque of potentiated twitches (TwPt)] were evaluated using electrically evoked contractions performed before and 1 min after each specific part of the trial. Gas exchange, power output (PO), and electromyographic activity (EMG) were also recorded. EMG/PO showed an abrupt increase followed by a continuous decrease toward the end of FS, resulting in a drop in IMVC (-12%), VA (-8%), and TwPt (-23%). EMG/PO was stable during EP, with no additional drop on IMVC, VA, or TwPt (-12%, -6%, and -22%, respectively). EMG/PO increased abruptly during the ES, but there was no change in IMVCs, VA, or TwPt (-13%, -8%, and -26%, respectively). These findings demonstrate that the performance fatigability during a self-paced exercise is characterized by a large drop in contractile function and muscle activation at the beginning of the trial (i.e., FS), without additional change during the middle and end phases (i.e., EP and ES). NEW & NOTEWORTHY  The time course of performance fatigability throughout a self-paced exercise is currently unknown. The results showed that a large amount of muscle activation and contractile function impairments are attained early on a self-paced exercise (first ∼15% of the total time trial distance) and maintained throughout the test. This novel finding characterizes the performance fatigability from a contractile function and muscle activation perspective, which brings new insights for future studies focused on real-world exercise training and competition.",2019,"EMG/PO increased abruptly during the ES, but there was no change on IMVC, VA and TwPt (-13%, -8% and -26%, respectively).",['Eleven male cyclists'],[],"['EMG/PO', 'isometric maximal voluntary contractions (IMVC), while the muscle activation [i.e., voluntary activation (VA)] and contractile function of knee extensors [i.g., peak torque of potentiated twitches (TwPt', 'contractile function and muscle activation', 'IMVC, VA and TwPt', 'Performance fatigability', 'IMVC', 'Gas exchange, power output (PO) and electromyographic activity (EMG']","[{'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch (finding)'}, {'cui': 'C0231230', 'cui_str': 'Fatigability (finding)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",11.0,0.0225631,"EMG/PO increased abruptly during the ES, but there was no change on IMVC, VA and TwPt (-13%, -8% and -26%, respectively).","[{'ForeName': 'Rafael de Almeida', 'Initials': 'RA', 'LastName': 'Azevedo', 'Affiliation': 'Endurance Performance Research Group, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Cruz', 'Affiliation': 'Endurance Performance Research Group, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Couto', 'Affiliation': 'Endurance Performance Research Group, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marcos David', 'Initials': 'MD', 'LastName': 'Silva-Cavalcante', 'Affiliation': 'Endurance Performance Research Group, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Boari', 'Affiliation': 'Center of Engineering Modeling and Applied Social Science, Federal University of ABC, São Paulo, Brazil.'}, {'ForeName': 'Adriano E', 'Initials': 'AE', 'LastName': 'Lima-Silva', 'Affiliation': 'Sport Science Research Group, Academic Center of Vitória, Federal University of Pernambuco, Pernambuco, Brazil.'}, {'ForeName': 'Guillaume Y', 'Initials': 'GY', 'LastName': 'Millet', 'Affiliation': 'Human Performance Laboratory, Faculty of Kinesiology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Bertuzzi', 'Affiliation': 'Endurance Performance Research Group, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00090.2019']
2787,31515680,Transition effects from laparocscopic to robotic surgery skills in small cavities.,"Conventional laparoscopic surgery (LS) is being challenged by the ever-increasing use of robotic surgery (RS) to perform reconstructive procedures. The purpose of this study was to assess the acquisition of skills in both techniques and the potential transfer of skills from one technique to the other when restricted spaces are involved. A preclinical randomized crossover study design was implemented. Twelve subjects performed two different reproducible drill procedures: ""Thread the Ring"" (TR) and ""Transfer the Plot"" (TP). To assess surgical proficiency in confined workspaces, these exercises were performed with LS and RS technology in a pediatric laparoscopic surgery (PLS) simulator. Each performance was recorded and evaluated by two reviewers using objective structured assessment of technical skills (OSATS). The times to complete the TP and the TR procedure were significantly shorter with RS compared to LS (64 s vs. 319 s; p < 0.0001 for both TP and TR). A significant transfer effect of skills between LS and RS was noted for the TP exercise (p = 0.006). The percentage improvement was greater overall with LS, meaning a higher number of trials were required to adequately master the procedure. This study demonstrated that RS performed significantly better compared to LS on pediatric simulation devices. A transfer effect was identified from LS to RS exclusively. The learning curves showed that progression was definitely longer with LS. These results, indicate that novice surgeons should be encouraged to persist with learning LS, and they support the use of a pediatric robotic simulation device.",2020,A significant transfer effect of skills between LS and RS was noted for the TP exercise (p = 0.006).,"['Twelve subjects performed two different reproducible drill procedures', 'small cavities']","['Conventional laparoscopic surgery (LS', 'robotic surgery (RS', 'pediatric laparoscopic surgery (PLS) simulator', 'Thread the Ring"" (TR) and ""Transfer the Plot"" (TP']","['times to complete the TP and the TR procedure', 'TP exercise']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0324815', 'cui_str': 'Drill'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",12.0,0.0200835,A significant transfer effect of skills between LS and RS was noted for the TP exercise (p = 0.006).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Moncayo', 'Affiliation': 'Service de Chirurgie Viscérale Pédiatrique, Hôpital des Enfants, 8 Avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Compagnon', 'Affiliation': 'Service de Chirurgie Viscérale Pédiatrique, Hôpital des Enfants, 8 Avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Caire', 'Affiliation': 'Service de Neurochirurgie, Hôpital Dupuytren, 2 Avenue Martin Luther King, 87042, Limoges Cedex, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Grosos', 'Affiliation': 'Service de Chirurgie Viscérale Pédiatrique, Hôpital des Enfants, 8 Avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bahans', 'Affiliation': 'Service de Chirurgie Viscérale Pédiatrique, Hôpital des Enfants, 8 Avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ilhero', 'Affiliation': 'Service de Chirurgie Viscérale Pédiatrique, Hôpital des Enfants, 8 Avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fourcade', 'Affiliation': 'Service de Chirurgie Viscérale Pédiatrique, Hôpital des Enfants, 8 Avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Ballouhey', 'Affiliation': 'Service de Chirurgie Viscérale Pédiatrique, Hôpital des Enfants, 8 Avenue Dominique Larrey, 87042, Limoges Cedex, France. q.ballouhey@gmail.com.'}]",Journal of robotic surgery,['10.1007/s11701-019-01024-y']
2788,32435483,"Effects of Maharishi Light Technology with Gems: A random-assignment, placebo-controlled, blinded pilot study.","Objectives


This blinded random-assignment, placebo-controlled pilot study investigated the effects of Maharishi Light Technology with Gems on three self-report measures: a questionnaire with a 5-point Likert-type scale, the Profile of Mood States (POMS), and an open-ended question. This pilot is the beginning of a research program to test the effects of this therapy.
Methods


In total, 18 meditating subjects received two treatments on consecutive days, randomly either Maharishi Light Technology or placebo, then 2 weeks rest, and then the other treatment on consecutive days.
Results


In comparison to placebo treatments, Maharishi Light Technology treatments were (1) rated as being significantly more settled, (2) higher on the Positive Self-Esteem subscale of the POMS and (3) described by the terms: healing, wholeness, and bliss.
Conclusion


These treatments lead to significant improvements on self-report measures. Future research could assess their effects across both meditating and nonmeditating populations, using physiological measures to probe possible mechanisms of the effects.",2020,"In comparison to placebo treatments, Maharishi Light Technology treatments were (1) rated as being significantly more settled, (2) higher on the Positive Self-Esteem subscale of the POMS and (3) described by the terms: healing, wholeness, and bliss.
",['18 meditating subjects'],"['Maharishi Light Technology', 'Maharishi Light Technology or placebo', 'placebo']",['Positive Self-Esteem subscale'],[],"[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2712312', 'cui_str': 'High self-esteem'}]",18.0,0.0752071,"In comparison to placebo treatments, Maharishi Light Technology treatments were (1) rated as being significantly more settled, (2) higher on the Positive Self-Esteem subscale of the POMS and (3) described by the terms: healing, wholeness, and bliss.
","[{'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Travis', 'Affiliation': 'Center for the Brain, Consciousness, and Cognition, Maharishi International University, Fairfield, IA, USA.'}, {'ForeName': 'Ayala', 'Initials': 'A', 'LastName': 'Melzer', 'Affiliation': 'College of Perfect Health, Vlodrop, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scharf', 'Affiliation': 'Department of Physics, Maharishi International University, Fairfield, IA, USA.'}]",SAGE open medicine,['10.1177/2050312120918272']
2789,32435467,Serum cobalt concentrations remain at low levels at a minimum of 20 years following metal-on-metal total hip arthroplasty.,"Aims


Second-generation metal-on-metal (MoM) articulations in total hip arthroplasty (THA) were introduced in order to reduce wear-related complications. The current study reports on the serum cobalt levels and the clinical outcome at a minimum of 20 years following THA with a MoM (Metasul) or a ceramic-on-polyethylene (CoP) bearing.
Methods


The present study provides an update of a previously published prospective randomized controlled study, evaluating the serum cobalt levels of a consecutive cohort of 100 patients following THA with a MoM or a CoP articulation. A total of 31 patients were available for clinical and radiological follow-up examination. After exclusion of 11 patients because of other cobalt-containing implants, 20 patients (MoM (n = 11); CoP (n = 9)) with a mean age of 69 years (42 to 97) were analyzed. Serum cobalt levels were compared to serum cobalt levels five years out of surgery.
Results


The median cobalt concentration in the MoM group was 1.04 μg/l (interquartile range (IQR) 0.64 to 1.70) at a mean of 21 years (20 to 24) postoperatively and these values were similar (p = 0.799) to cobalt levels at five years. In the CoP control group, the median cobalt levels were below the detection limit (< 0.3 μg/l; median 0.15 μg/l, IQR 0.15 to 0.75) at 20 years. The mean Harris Hip Score was 91.4 points (61 to 100) in the MoM group and 92.8 points (63 to 100) in the CoP group.
Conclusion


This study represents the longest follow-up series evaluating the serum cobalt levels after 28 mm head MoM bearing THA and shows that serum cobalt concentrations remain at low levels at a mean of 21 years (20 to 24) after implantation. Cite this article:   Bone Joint Res.  2020;9(3):145-150.",2020,"The mean Harris Hip Score was 91.4 points (61 to 100) in the MoM group and 92.8 points (63 to 100) in the CoP group.
","['11 patients because of other cobalt-containing implants, 20 patients (MoM (n = 11); CoP (n = 9)) with a mean age of 69 years (42 to 97) were analyzed', 'total hip arthroplasty (THA', '100 patients following THA with a MoM or a CoP articulation', '31 patients were available for clinical and radiological follow-up examination']","['generation metal-on-metal (MoM) articulations', 'THA with a MoM (Metasul) or a ceramic-on-polyethylene (CoP) bearing']","['Serum cobalt levels', 'mean Harris Hip Score', 'median cobalt concentration', 'serum cobalt levels', 'median cobalt levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",31.0,0.0330795,"The mean Harris Hip Score was 91.4 points (61 to 100) in the MoM group and 92.8 points (63 to 100) in the CoP group.
","[{'ForeName': 'Wenzel', 'Initials': 'W', 'LastName': 'Waldstein', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Vienna General Hospital, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Koller', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Vienna General Hospital, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Springer', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Vienna General Hospital, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kolbitsch', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Vienna General Hospital, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Brodner', 'Affiliation': 'Department of Orthopedics, University Hospital Krems, Krems, Austria.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Windhager', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Vienna General Hospital, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lass', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Vienna General Hospital, Medical University of Vienna, Vienna, Austria.'}]",Bone & joint research,['10.1302/2046-3758.93.BJR-2019-0218.R1']
2790,32435317,Comparative Effectiveness of Caregiver Training in Mindfulness-Based Positive Behavior Support (MBPBS) and Positive Behavior Support (PBS) in a Randomized Controlled Trial.,"Caregivers of individuals with intellectual and developmental disabilities are often stressed due to the demands of the job, including the nature and severity of challenging behaviors of the clients, work conditions, degree of management support for the staff, and the demands of implementing some interventions under adverse conditions. Mindfulness-Based Positive Behavior Support (MBPBS) and PBS alone have been shown to be effective in assisting caregivers to better manage the challenging behaviors of clients with intellectual and developmental disabilities. The aim of the present study was to undertake a head-to-head assessment of the effectiveness of MBPBS and PBS alone in a 40-week randomized controlled trial. Of the 123 caregivers who met inclusion criteria, 60 were randomly assigned to MBPBS and 63 to PBS alone, with 59 completing the trial in the MBPBS condition and 57 in the PBS alone condition. Results showed both interventions to be effective, but the caregiver, client, and agency outcomes for MBPBS were uniformly superior to those of PBS alone condition. In addition, the MBPBS training was substantially more cost-effective than the PBS alone training. The present results add to the evidence base for the effectiveness of MBPBS and, if independently replicated, could provide an integrative health care approach in the field of intellectual and developmental disabilities.",2020,"Results showed both interventions to be effective, but the caregiver, client, and agency outcomes for MBPBS were uniformly superior to those of PBS alone condition.","['Caregivers of individuals with intellectual and developmental disabilities', 'clients with intellectual and developmental disabilities', '123 caregivers who met inclusion criteria, 60 were randomly assigned to MBPBS and 63 to PBS alone, with 59 completing the trial in the MBPBS condition and 57 in the PBS alone condition']","['MBPBS training', 'Caregiver Training in Mindfulness-Based Positive Behavior Support (MBPBS) and Positive Behavior Support (PBS', 'MBPBS and PBS', 'Mindfulness-Based Positive Behavior Support (MBPBS) and PBS alone']","['caregiver, client, and agency outcomes for MBPBS', 'cost-effective']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",123.0,0.0447637,"Results showed both interventions to be effective, but the caregiver, client, and agency outcomes for MBPBS were uniformly superior to those of PBS alone condition.","[{'ForeName': 'Nirbhay N', 'Initials': 'NN', 'LastName': 'Singh', 'Affiliation': '1Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA 30912 USA.'}, {'ForeName': 'Giulio E', 'Initials': 'GE', 'LastName': 'Lancioni', 'Affiliation': '2Department of Neuroscience and Sense Organs, University of Bari, Bari, Italy.'}, {'ForeName': 'Oleg N', 'Initials': 'ON', 'LastName': 'Medvedev', 'Affiliation': '3Centre for Medical and Health Sciences Education, School of Medicine, University of Auckland, Auckland, 1142 New Zealand.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Myers', 'Affiliation': '4WellStar School of Nursing, Kennesaw State University, Kennesaw, GA USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Movement for the Intellectually Disabled of Singapore, Singapore, Singapore.'}, {'ForeName': 'Carrie L', 'Initials': 'CL', 'LastName': 'McPherson', 'Affiliation': 'McPherson Therapy and Consulting, Greenville, KY USA.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Jackman', 'Affiliation': 'Little Lotus Therapy and Consulting, Port St. Lucie, FL USA.'}, {'ForeName': 'Eunjin', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': '8Institute of Mind Humanities, Wonkwang University, Iksan, South Korea.'}]",Mindfulness,['10.1007/s12671-018-0895-2']
2791,32435738,Openness to experience predicts dopamine effects on divergent thinking.,"Individual differences in trait levels of openness to experience and creativity have been theoretically linked to dopamine function. However, empirical evidence for this assumption is scarce, especially for causal connections. The present study aims to directly assess the influence of dopamine activity on the established association between openness to experience and divergent thinking (i.e., an index of creativity). We hypothesized that manipulating dopamine activity alters the relationship between self-reported openness to experience and ideational fluency and flexibility. In a placebo-controlled between-subjects design, 193 healthy male volunteers completed four divergent thinking tasks after they received either the dopamine-receptor blocker sulpiride (200 mg) or a placebo. The data revealed an interaction such that openness to experience was more positively associated with divergent thinking in the dopamine blocker group ( r  = 0.304) than in the placebo group ( r  = -0.002). Specifically, highly open individuals in the dopamine blocker group reached the highest divergent thinking scores. Thus, sulpiride administration selectively affected divergent thinking as a function of trait levels of openness to experience. Although somewhat limited by the unexpected absence of the association between openness to experience and divergent thinking in the placebo group, the present study provides novel evidence for an association between dopamine activity and both openness to experience and divergent thinking.",2019,The data revealed an interaction such that openness to experience was more positively associated with divergent thinking in the dopamine blocker group ( r  = 0.304) than in the placebo group ( r  = -0.002).,['193 healthy male volunteers'],"['dopamine blocker', 'dopamine-receptor blocker sulpiride', 'placebo']","['divergent thinking', 'highest divergent thinking scores']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0242702', 'cui_str': 'Dopamine receptor antagonist'}, {'cui': 'C0034798', 'cui_str': 'Dopamine receptor'}, {'cui': 'C0038803', 'cui_str': 'Sulpiride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",193.0,0.0208814,The data revealed an interaction such that openness to experience was more positively associated with divergent thinking in the dopamine blocker group ( r  = 0.304) than in the placebo group ( r  = -0.002).,"[{'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Käckenmester', 'Affiliation': 'Institute for Psychology, Universität Hamburg, Hamburg, DE Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Bott', 'Affiliation': 'Institute for Psychology, Universität Hamburg, Hamburg, DE Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wacker', 'Affiliation': 'Institute for Psychology, Universität Hamburg, Hamburg, DE Germany.'}]",Personality neuroscience,['10.1017/pen.2019.3']
2792,31285591,Randomised phase II trial of mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab as first-line treatment for colorectal liver metastasis (ATOM trial).,"BACKGROUND


Chemotherapy with biologics followed by liver surgery improves the resection rate and survival of patients with colorectal liver metastasis (CRLM). However, no prospective study has compared the outcomes of chemotherapy with bevacizumab (BEV) versus cetuximab (CET).
METHODS


The ATOM study is the first randomised trial comparing BEV and CET for initially unresectable CRLM. Patients were randomly assigned in a 1:1 ratio to receive mFOLFOX6 plus either BEV or CET. The primary endpoint was progression-free survival (PFS).
RESULTS


Between May 2013 and April 2016, 122 patients were enrolled. Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33). Patients with a smaller-number but larger-sized metastases did better in the CET group. In the BEV and CET groups, the response rates were 68.4% and 84.7% and the resection rates were 56.1% and 49.2%, respectively.
CONCLUSION


Although CET achieved a better response rate than BEV for patients with a small number of large liver metastases, both biologics had similar efficacy regarding liver resection and acceptable safety profiles. To achieve optimal PFS, biologics should be selected in accordance with patient conditions.
TRIAL REGISTRATION


This trial is registered at ClinicalTrials.gov (number NCT01836653), and UMIN Clinical Trials Registry (UMIN-CTR number UMIN000010209).",2019,Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33).,"['Between May 2013 and April 2016, 122 patients were enrolled', 'patients with colorectal liver metastasis (CRLM']","['mFOLFOX6 plus either BEV or CET', 'CET', 'mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab', 'chemotherapy with bevacizumab (BEV) versus cetuximab (CET']","['progression-free survival (PFS', 'resection rates', 'response rates', 'response rate', 'resection rate and survival', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",122.0,0.166579,Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33).,"[{'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Oki', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. okieiji@surg2.med.kyushu-u.ac.jp.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Emi', 'Affiliation': 'Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uetake', 'Affiliation': 'Department of Surgical Oncology and Gastroenterology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagasaka', 'Affiliation': 'Department of Clinical Oncology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Hatano', 'Affiliation': 'Department of Hepato-Biliary-Pancreatic Surgery, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ojima', 'Affiliation': 'Department of Surgery, Gunma Prefectural Cancer Center, Ota, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Manaka', 'Affiliation': 'Department of Surgery, Kyoto Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Kusumoto', 'Affiliation': 'Department of Surgery, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Katayose', 'Affiliation': 'Department of Hepatobiliary and Pancreatic, Tohoku Medical and Pharmaceutical University, Sendai, Japan.'}, {'ForeName': 'Toshiyoshi', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Unno', 'Affiliation': 'Department of Surgery, Tohoku University, Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Tomita', 'Affiliation': 'Divison of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Sugihara', 'Affiliation': 'Department of Surgical Oncology and Gastroenterology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Maehara', 'Affiliation': 'Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.'}]",British journal of cancer,['10.1038/s41416-019-0518-2']
2793,32436160,"Effect of orally administered magnesium on postoperative pain level and trismus after surgical removal of the lower third molars: a randomized, double-blind, placebo-controlled trial.","OBJECTIVES


Pain and trismus are the most common postoperative complications following a surgical removal of the lower third molar. This randomized, double-blind, placebo-controlled clinical trial evaluated the effect of orally administrated magnesium on postoperative pain and trismus after surgical removal of the lower third molars.
MATERIALS AND METHODS


The study was conducted on 80 participants who were divided into two groups. Each group took different oral forms of magnesium citrate. Participants in both groups had their two lower molars surgically removed. For one randomly selected third molar, participants received either magnesium citrate tablets or lozenges. For the surgical removal of the lower third molar of the opposite side, the participants received either placebo tablets or lozenges. The data were analyzed using the Wilcoxon signed-ranked test, the Mann-Whitney U test, and the Spearman rank-order correlation with the level of significance set at p < 0.05. This manuscript was written in accordance with the Consort recommendation.
RESULTS


The results show a statistically significant lower pain level at all tested times (24 h, 48 h, and 72 h postoperatively) for participants who used magnesium preparations in lozenges (p = 0.012, p = 0.013, and p ≤ 0.001) as well as in tablet form (p ≤ 0.001) compared to placebo. The results also show a statistically significant greater mouth opening ability at all tested times (24 h, 48 h, and 72 h postoperatively) between magnesium preparations and the placebo (p ≤ 0.001).
CONCLUSION


Orally administered magnesium (either lozenges or tablets) before and after a lower third molar surgical removal significantly reduces pain intensity and the degree of trismus in the postoperative period.
CLINICAL RELEVANCE


Based on the results of the study, oral magnesium could be used in the oral and maxillofacial surgery to reduce postoperative complications after surgical removal of the lower third molars.
TRIAL REGISTRATION


This study is registered on http:clinicaltrials.gov under protocol no. NCT03398382.",2020,"The results show a statistically significant lower pain level at all tested times (24 h, 48 h, and 72 h postoperatively) for participants who used magnesium preparations in lozenges (p = 0.012, p = ","['80 participants who were divided into two groups', 'after surgical removal of the lower third molars']","['magnesium citrate tablets or lozenges', 'magnesium citrate', 'placebo tablets or lozenges', 'magnesium', 'placebo']","['pain level', 'postoperative pain level and trismus', 'pain intensity and the degree of trismus', 'postoperative pain and trismus', 'mouth opening ability']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0126774', 'cui_str': 'magnesium citrate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",80.0,0.633874,"The results show a statistically significant lower pain level at all tested times (24 h, 48 h, and 72 h postoperatively) for participants who used magnesium preparations in lozenges (p = 0.012, p = ","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jerkovic', 'Affiliation': 'Department of Maxillofacial Surgery, Study of Dental Medicine, School of Medicine, Clinical Hospital Centre, University of Split, Spinciceva 1, 21000, Split, Croatia. djerkovic@sfzg.hr.'}, {'ForeName': 'Antonija', 'Initials': 'A', 'LastName': 'Tadin', 'Affiliation': 'Department of Restorative Dental Medicine and Endodontics, Study of Dental Medicine, School of Medicine, University of Split, Split, Croatia.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Gavic', 'Affiliation': 'Department for Oral Medicine and Periodontology, Study of Dental Medicine, School of Medicine, University of Split, Split, Croatia.'}, {'ForeName': 'Nada Zorica', 'Initials': 'NZ', 'LastName': 'Vladislavic', 'Affiliation': 'School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Grgic', 'Affiliation': 'School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Darko', 'Initials': 'D', 'LastName': 'Macan', 'Affiliation': 'Department of Maxillofacial and Oral Surgery, School of Dental Medicine, University of Zagreb, University Hospital Dubrava, Zagreb, Croatia.'}]",Clinical oral investigations,['10.1007/s00784-020-03335-z']
2794,32435430,Esthetic outcome of immediately placed and nonfunctionally loaded implants in the anterior maxilla utilizing a definitive abutment: A pilot clinical trial.,"Background


Immediate dental implants placement and loading utilizing definitive abutments might save time and cost when an esthetic final result is anticipated. The objective of this prospective clinical trial was to evaluate the esthetic outcome of immediate implantation and immediate nonfunctional loading utilizing definitive abutments, with and without bony substitutes filling the peri-implant gap.
Materials and Methods


In this clinical trial study a total of 11 implants were placed utilizing a flapless immediate post extraction approach in the maxilla (second premolar to second premolar). Atraumatic extraction was performed and implants were immediately placed. The gap was either left without grafting or filled with particulate bone material. Immediate nonfunctional loading was performed utilizing a definitive abutment. The pink esthetic scores (PESs) were assessed preoperatively, at 1- and 2-year follow-up periods. Dental casts were obtained at respective time intervals; scanned, registered, and closest point distances were measured. For all statistical tests, value of  P  = 0.05 was set as a statistical significance level.
Results


The mean of PES at baseline was 9.4 ± 1.69, at 1 year was 9.5 ± 2.07, at 2 years was 10.2 ± 2.75, for the graft group 10.3 ± 2.8, and for nongrafting group was 10.2 ± 2.59. There were no statistically significant differences in PESs at baseline when compared to 1- and 2-year intervals, and for grafting group versus nongrafting group ( P  = 0.24). Distances between the two time points for all cases were <1 mm in all reference planes.
Conclusion


Immediate placement and nonfunctional loading utilizing a definitive abutment appear to result in a stable result as far as esthetic outcome and alveolar process sufficiency are concerned.",2020,"There were no statistically significant differences in PESs at baseline when compared to 1- and 2-year intervals, and for grafting group versus nongrafting group ( P  = 0.24).","['11 implants were placed utilizing a flapless immediate post extraction approach in the maxilla (second premolar to second premolar', 'anterior maxilla utilizing a definitive abutment']","['immediately placed and nonfunctionally loaded implants', 'left without grafting or filled with particulate bone material', 'immediate implantation and immediate nonfunctional loading utilizing definitive abutments, with and without bony substitutes filling the peri-implant gap']","['pink esthetic scores (PESs', 'mean of PES', 'PESs']","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0459697', 'cui_str': 'Anterior segment of maxilla'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}]","[{'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0443157', 'cui_str': 'Bony'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}]","[{'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",11.0,0.0890477,"There were no statistically significant differences in PESs at baseline when compared to 1- and 2-year intervals, and for grafting group versus nongrafting group ( P  = 0.24).","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'AlTarawneh', 'Affiliation': 'Department of Prosthodontics, School of Dentistry, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Ahmad A S', 'Initials': 'AAS', 'LastName': 'Hamdan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Oral Medicine and Periodontology, School of Dentistry, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'Alhadidi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Oral Medicine and Periodontology, School of Dentistry, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hattar', 'Affiliation': 'Department of Conservative Dentistry and Fixed Prosthodontics, School of Dentistry, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': ""Al-Rabab'ah"", 'Affiliation': 'Department of Conservative Dentistry and Fixed Prosthodontics, School of Dentistry, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Baqain', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Oral Medicine and Periodontology, School of Dentistry, The University of Jordan, Amman, Jordan.'}]",Dental research journal,[]
2795,32435762,Protocol for two-arm pragmatic cluster randomized hybrid implementation-effectiveness trial comparing two education strategies for improving the uptake of noninvasive ventilation in patients with severe COPD exacerbation.,"Background


COPD is the fourth leading cause of death in the US, and COPD exacerbations result in approximately 700,000 hospitalizations annually. Patients with acute respiratory failure due to severe COPD exacerbation are treated with invasive (IMV) or noninvasive mechanical ventilation (NIV). Although IMV reverses hypercapnia/hypoxia, it causes significant morbidity and mortality. There is strong evidence that patients treated with NIV have better outcomes, and NIV is recommended as first line therapy in these patients. Yet, several studies have demonstrated substantial variation in the use of NIV across hospitals, leading to preventable morbidity and mortality. Through a series of mixed-methods studies, we have found that successful implementation of NIV requires physicians, respiratory therapists (RTs), and nurses to communicate and collaborate effectively, suggesting that efforts to increase the use of NIV in COPD need to account for the complex and interdisciplinary nature of NIV delivery and the need for team coordination. Therefore, we propose to compare two educational strategies: online education (OLE) and interprofessional education (IPE) which targets complex team-based care in NIV delivery.
Methods and design


Twenty hospitals with low baseline rates of NIV use will be randomized to either the OLE or IPE study arm. The primary outcome of the trial is change in the hospital rate of NIV use among patients with COPD requiring ventilatory support. In aim 1, we will compare the uptake change over time of NIV use among patients with COPD in hospitals enrolled in the two arms. In aim 2, we will explore mediators' role (respiratory therapist autonomy and team functionality) on the relationship between the implementation strategies and implementation effectiveness. Finally, in aim 3, through interviews with providers, we will assess acceptability and feasibility of the educational training.
Discussions


This study will be among the first to carefully test the impact of IPE in the inpatient setting. This work promises to change practice by offering approaches to facilitate greater uptake of NIV and may generalize to other interventions directed to seriously-ill patients.
Trial registration


Name of registry: ClinicalTrials.govTrial registration number: NCT04206735Date of Registration: December 20, 2019.",2020,The primary outcome of the trial is change in the hospital rate of NIV use among patients with COPD requiring ventilatory support.,"['Twenty hospitals with low baseline rates of NIV use', 'patients with COPD requiring ventilatory support', 'patients with severe COPD exacerbation', 'Patients with acute respiratory failure due to severe COPD exacerbation', 'ClinicalTrials.govTrial registration number', 'patients with COPD in hospitals enrolled in the two arms', 'Trial registration\n\n\nName of registry']","['invasive (IMV) or noninvasive mechanical ventilation (NIV', 'OLE', 'educational strategies: online education (OLE) and interprofessional education (IPE) which targets complex team-based care in NIV delivery']",['hospital rate of NIV use'],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1868982', 'cui_str': 'Noninvasive mechanical ventilation'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1868982', 'cui_str': 'Noninvasive mechanical ventilation'}, {'cui': 'C4505477', 'cui_str': 'Online Education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1868982', 'cui_str': 'Noninvasive mechanical ventilation'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",20.0,0.289848,The primary outcome of the trial is change in the hospital rate of NIV use among patients with COPD requiring ventilatory support.,"[{'ForeName': 'Mihaela S', 'Initials': 'MS', 'LastName': 'Stefan', 'Affiliation': '1Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School-Baystate, Springfield, MA USA.'}, {'ForeName': 'Penelope S', 'Initials': 'PS', 'LastName': 'Pekow', 'Affiliation': '1Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School-Baystate, Springfield, MA USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Shea', 'Affiliation': '4Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina-Chapel Hill, Chapel Hill, NC USA.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Hughes', 'Affiliation': '5College of Applied Health Science, University of Illinois at Chicago, Chicago, IL USA.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Hill', 'Affiliation': '6Division of Pulmonary and Critical Care Medicine, Tufts University School of Medicine, Boston, MA USA.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Steingrub', 'Affiliation': '7Division of Pulmonary and Critical Care, Department of Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA USA.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Lindenauer', 'Affiliation': '1Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School-Baystate, Springfield, MA USA.'}]",Implementation science communications,['10.1186/s43058-020-00028-2']
2796,32435352,Contact Force-Guided Ablation Reduced Poor Contact Segments and Improved Acute Reconnection in Patients with Atrial Fibrillation.,"Background


There is a paucity of information regarding whether contact force (CF)-guided ablation improves the outcomes of pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF) by achieving more optimal contact. We sought to assess whether real time CF-guided ablation has an impact on ablation parameters and acute pulmonary vein reconnection (PVR).
Methods


Left or right PVs were randomized to either CF-guided or blinded groups, and the order of CF blindness: CF-guided left PV/CF-blinded right PV, CF-blinded left PV/CF-guided right PV, CF-guided right PV/CF-blinded left PV, and CF-blinded right PV/CF-guided left PV groups. We compared CF parameters and acute PVR between segments ablated by CF-guided and CF-blinded strategies.
Results


Sixty patients with drug refractory symptomatic AF were included (paroxysmal AF 73%). CF-guided segments did not show significant differences in CF parameters compared to CF-blinded segments. However, CF-guided segments showed fewer segments with mean CF value <5 g than CF-blinded segments (4.3% vs. 12.4%, p<0.001). Forty-two patients showed acute PVR in 92 segments (8.5%). CF-guided PV segments showed lower acute PVR rate than CF-blinded segments (5.9% vs. 11.1%, p=0.011).
Conclusions


CF-guided ablation could reduce acute PVR after PVI by decreasing the number of segments with poor contact rather than increasing the mean CF during ablation. Better contact guided by CF information might help in improving the results of PVI. Further investigation will be needed to identify the association between the difference in acute reconnection and the long-term outcomes.",2020,CF-guided segments did not show significant differences in CF parameters compared to CF-blinded segments.,"['Patients with Atrial Fibrillation', 'Sixty patients with drug refractory symptomatic AF', 'patients with atrial fibrillation (AF']","['contact force (CF)-guided ablation', 'Contact Force-Guided Ablation Reduced Poor Contact Segments', 'real time CF-guided ablation', 'CF blindness: CF-guided left PV/CF-blinded right PV, CF-blinded left PV/CF-guided right PV, CF-guided right']","['acute PVR rate', 'acute PVR', 'Acute Reconnection', 'CF parameters', 'CF parameters and acute PVR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",60.0,0.0999982,CF-guided segments did not show significant differences in CF parameters compared to CF-blinded segments.,"[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'So-Ryoung', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Park', 'Initials': 'P', 'LastName': 'Hyoung-Seob', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University, Dongsan Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Choi', 'Initials': 'C', 'LastName': 'Eue-Keun', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kwon', 'Initials': 'K', 'LastName': 'Soonil', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Cho', 'Initials': 'C', 'LastName': 'Youngjin', 'Affiliation': 'Department of Internal Medicine, Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Oh', 'Initials': 'O', 'LastName': 'Il-Young', 'Affiliation': 'Department of Internal Medicine, Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Oh', 'Initials': 'O', 'LastName': 'Seil', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Seongwook', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University, Dongsan Medical Center, Daegu, Republic of Korea.'}]",Journal of atrial fibrillation,['10.4022/jafib.2185']
2797,32435443,"Self-administration of medication: a pragmatic randomized controlled trial of the impact on dispensing errors, perceptions, and satisfaction.","Background


Our aim was to investigate whether self-administration of medication (SAM) during hospitalization affects the number of dispensing errors, perceptions regarding medication, and participant satisfaction when compared with nurse-led medication dispensing.
Methods


A pragmatic randomized controlled trial was performed in a Danish cardiology unit. Patients aged ⩾ 18 years capable of SAM were eligible for inclusion. Patients were excluded if they did not self-administer medication at home, were not prescribed medication suitable for self-administration, or did not speak Danish.Intervention group participants self-administered their medication. In the control group, medication was dispensed and administered by nurses.The primary outcome was the proportion of dispensing errors collected through modified disguised observation of participants and nurses. Dispensing errors were divided into clinical and procedural errors.Secondary outcomes were explored through telephone calls to determine participant perceptions regarding medication and satisfaction, and finally, deviations in their medication list two weeks after discharge.
Results


Significantly fewer dispensing errors were observed in the intervention group, with 100 errors/1033 opportunities for error (9.7%), compared with 132 errors/1028 opportunities for error (12.8%) in the control group. The number of clinical errors was significantly reduced, whereas no difference in procedural errors was observed. At follow up, those who were self-administering medication had fewer concerns regarding their medication, found medication to be less harmful, were more satisfied, preferred this opportunity in the future, and had fewer deviations in their medication list after discharge compared with the control group.
Conclusion


In conclusion, the reduced number of dispensing errors in the intervention group, indicate that SAM is safe. In addition, SAM had a positive impact on (a) perceptions regarding medication, thus suggesting increased medication adherence, (b) deviations in medication list after discharge, and (c) participant satisfaction related to medication management at the hospital.",2020,"At follow up, those who were self-administering medication had fewer concerns regarding their medication, found medication to be less harmful, were more satisfied, preferred this opportunity in the future, and had fewer deviations in their medication list after discharge compared with the control group.
","['Danish cardiology unit', 'Patients were excluded if they did not self-administer medication at home, were not prescribed medication suitable for self-administration, or did not speak Danish', 'Patients aged ⩾\u200918\u2009years capable of SAM were eligible for inclusion']","['Intervention group participants self-administered their medication', 'self-administration of medication (SAM', 'Self-administration of medication', 'SAM']","['reduced number of dispensing errors', 'telephone calls to determine participant perceptions regarding medication and satisfaction, and finally, deviations in their medication list two weeks after discharge', 'dispensing errors', 'medication adherence, (b) deviations in medication list after discharge, and (c) participant satisfaction', 'number of clinical errors', 'proportion of dispensing errors', 'dispensing errors, perceptions, and satisfaction', 'procedural errors']","[{'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0564217', 'cui_str': 'Does not speak'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.0911021,"At follow up, those who were self-administering medication had fewer concerns regarding their medication, found medication to be less harmful, were more satisfied, preferred this opportunity in the future, and had fewer deviations in their medication list after discharge compared with the control group.
","[{'ForeName': 'Charlotte Arp', 'Initials': 'CA', 'LastName': 'Sørensen', 'Affiliation': 'Randers Regional Hospital, Dronningborg Boulevard 16D, Randers NØ 8930, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lisby', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Olesen', 'Affiliation': 'Hospital Pharmacy Central Denmark Region, Clinical Pharmacy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Enemark', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Signe Bredsgaard', 'Initials': 'SB', 'LastName': 'Sørensen', 'Affiliation': 'Medical Department, Cardiology Unit, Randers Regional Hospital, Randers, Midtjylland, Denmark.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'de Thurah', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",Therapeutic advances in drug safety,['10.1177/2042098620904616']
2798,32435717,"Effects of transcranial direct current stimulation over frontal, parietal and cerebellar cortex for cognitive function during fasting in healthy adults.","Background


Transcranial direct current stimulation (tDCS) is a neuromodulation tool used to modify the cognitive function in subjects. There is a paucity of data on tDCS' effect on cognitive function during Ramadan fasting. This paper aims to assess the effect of tDCS of three brain areas, including the right dorsolateral prefrontal cortex (DLPFC), posterior parietal cortex (PPC), and cerebellum on cognitive function, and obtain safety data in healthy adults during Ramadan fasting.
Methods and material


A total of 42 healthy, right-handed participants were randomly assigned to one of the 6 stimulation groups: active (anodal)-tDCS of right DLPFC, PPC, and cerebellum; or sham for DLPFC, PPC, and cerebellum after 8 h of fasting for Ramadan. Safety data and cognitive function, such as attention-switching tasks (AST), were obtained by employing the Cambridge Neuropsychological Test Automated Battery (CANTAB) before and after each tDCS session. The cognitive function outcome variables were the response time and the percentage of correct answers in AST. For sham stimulation, the placement of the electrodes was the same as for the active stimulation.
Results


An improvement in performance time in attention tasks was observed; however, it did not reach a significant level after anodal stimulation of the DLPFC, PPC, and cerebellum. Overall, there were no statistically significant differences between the active and sham tDCS groups in cognitive function. There were no significant side effects of tDCS during fasting for any group.
Conclusions


Our data suggest that there are variable effects of tDCS on attention tasks during Ramadan fasting. TDCS appears to be safe, well-tolerated and adhered to the international standard of safety in the local population during Ramadan fasting. Further large sample size studies should be conducted to validate the current study findings and reach better conclusions.",2020,"TDCS appears to be safe, well-tolerated and adhered to the international standard of safety in the local population during Ramadan fasting.","['subjects', 'healthy adults during Ramadan fasting', 'healthy adults', '42 healthy, right-handed participants']","['active (anodal)-tDCS of right DLPFC, PPC, and cerebellum; or sham for DLPFC, PPC, and cerebellum after 8\u2009h of fasting for Ramadan', 'transcranial direct current stimulation', 'TDCS', 'tDCS', '\n\n\nTranscranial direct current stimulation (tDCS']","['cognitive function', 'response time and the percentage of correct answers in AST', 'right dorsolateral prefrontal cortex (DLPFC), posterior parietal cortex (PPC), and cerebellum on cognitive function', 'performance time in attention tasks', 'Safety data and cognitive function, such as attention-switching tasks (AST']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C3853037', 'cui_str': 'Posterior Parietal Cortex'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C3853037', 'cui_str': 'Posterior Parietal Cortex'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",42.0,0.0448109,"TDCS appears to be safe, well-tolerated and adhered to the international standard of safety in the local population during Ramadan fasting.","[{'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Alsultan', 'Affiliation': 'Department of Medicine, King Saud Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Malak', 'Initials': 'M', 'LastName': 'Alaboudi', 'Affiliation': 'Department of Medicine, King Saud Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Almousa', 'Affiliation': 'Department of Medicine, King Saud Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Alajaji', 'Affiliation': 'Department of radiology, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Bashir', 'Affiliation': 'Neuroscience Center, King Fahad Specialist Hospital, Dammam, Saudi Arabia.'}]",IBRO reports,['10.1016/j.ibror.2020.03.002']
2799,32435718,Feasibility and acceptability of testing a menstrual-cycle timed smoking cessation intervention for women of reproductive age ( Project Phase ): Protocol of a pilot randomized controlled trial.,"Background


Compared to men, women have unique barriers to smoking cessation and are less likely to utilize quitline services. While current clinical recommendations have called for sex/gender-specific smoking cessation protocols, quitlines have not been expanded protocols to address the unique needs of women. Menstrual cycles (and/or ovarian hormones) influence quit outcomes in women. This paper presents the study design and protocol for a randomized control trial ( Project Phase ) designed to test the feasibility and acceptability of utilizing menstrual cycle timing to improve quit outcomes in women of reproductive age.
Methods/design


Participants include treatment-seeking women (n = 116), between the ages of 18-40 with regular and naturally-occurring menstrual cycles. Eligible participants are randomized to either the mid-Follicular Phase (FP) or Standard Care (SC-control) group. Counseling includes six weekly telephone sessions with four weeks of nicotine replacement therapy. The timing and frequency of sessions is identical to both conditions, with the exception of the quit day (week 3 of counseling). In addition to providing education on menstrual cycle and quitting, quit day for FP participants is set within 6-8 days post onset of menses; the SC group quit day is set for Week 3 of counseling regardless of their menstrual cycle phase. Dried blood spots will be used to bioverify menstrual cycle phase and smoking status.
Discussion


If feasible and acceptable, our behavioral counseling intervention that times the quit day to the mid-follicular phase of the menstrual may increase quit outcomes among women of reproductive age and has potential for dissemination across quitlines nationally.",2020,Eligible participants are randomized to either the mid-Follicular Phase (FP) or Standard Care (SC-control) group.,"['Participants include treatment-seeking women (n\xa0=\xa0116), between the ages of 18-40 with regular and naturally-occurring menstrual cycles', 'women of reproductive age', 'women']","['mid-Follicular Phase (FP) or Standard Care (SC-control', 'testing a menstrual-cycle timed smoking cessation intervention', 'nicotine replacement therapy']","['Menstrual cycles (and/or ovarian hormones) influence quit outcomes', 'quit outcomes']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}]","[{'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Proliferative Phase'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0729511', 'cui_str': 'Ovarian hormone'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0629105,Eligible participants are randomized to either the mid-Follicular Phase (FP) or Standard Care (SC-control) group.,"[{'ForeName': 'Uma S', 'Initials': 'US', 'LastName': 'Nair', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Miller', 'Affiliation': 'Department of health Promotion Sciences, Mel and Enid Zuckerman College of Public Heath, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Bell', 'Affiliation': 'Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota Medical School, MN, USA.'}, {'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Collins', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Allen', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine, University of Arizona, Tucson, AZ, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100569']
2800,32435445,Reduction of potentially inappropriate medication in the elderly: design of a cluster-randomised controlled trial in German primary care practices (RIME).,"Background


Potentially inappropriate medication (PIM) is considered to have potentially more harmful than beneficial health effects in elderly patients. A German example for a PIM list is the PRISCUS list that has been available since 2010. PIMs are associated with an increased risk of hospitalisation and adverse health outcomes. Furthermore, drug-drug interactions (DDI) may pose additional risks to patients. It is not yet clear how numbers of PIM and DDI can be reduced in community-dwelling seniors in primary care; nor is it clear whether patients would benefit from such deprescribing.
Methods


The cluster-randomised controlled study on the ""Reduction of potentially Inappropriate Medication in the Elderly"" (RIME study) is designed to examine whether an intervention based on the PRISCUS list can lower the proportion of community-dwelling people of ⩾70 years taking at least one PIM and/or medication inducing at least one dangerous DDI. The intervention consists of professional education and training on the reduction of PIM and DDI, and will be offered to either general practitioners (GPs) alone or GPs and their office staff in the experimental study arm. The control group will be offered professional education and training on more general issues of prescribing in the elderly, not specifically addressing PIM or DDI. The primary endpoint is the difference in the proportion of patients with at least one PIM or DDI between the start of the study and study closure after 12 months as compared between intervention and control group. Secondary endpoints include overall mortality, number of hospitalisations during the course of the study, quality of life and costs. Secondary analyses will be explorative, with the cluster randomisation being factored in.
Discussion


The RIME study will contribute to answering the question of whether an intervention based on the PRISCUS list can reduce the proportion of community-dwelling seniors aged ⩾70 years with at least one PIM and/or DDI, and whether this will result in positive health effects, for example, as regards hospitalisations.
Trial registration


The Study has been registered in the German Clinical Trials Register (DRKS) under the number DRKS00003610.",2020,"The cluster-randomised controlled study on the ""Reduction of potentially Inappropriate Medication in the Elderly"" (RIME study) is designed to examine whether an intervention based on the PRISCUS list can lower the proportion of community-dwelling people of ⩾70 years taking at least one PIM and/or medication inducing at least one dangerous DDI.","['German primary care practices (RIME', 'community-dwelling seniors aged ⩾70\u2009years with at least one PIM and/or DDI', 'community-dwelling people of ⩾70\u2009years taking at least one PIM and/or medication inducing at least one dangerous DDI', 'elderly patients']","['professional education and training on the reduction of PIM and DDI, and will be offered to either general practitioners (GPs) alone or GPs', '\n\n\nPotentially inappropriate medication (PIM', 'professional education and training on more general issues of prescribing in the elderly, not specifically addressing PIM or DDI']","['risk of hospitalisation and adverse health outcomes', 'overall mortality, number of hospitalisations during the course of the study, quality of life and costs', 'proportion of patients with at least one PIM or DDI']","[{'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0687133', 'cui_str': 'Drug interaction with drug'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0687133', 'cui_str': 'Drug interaction with drug'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0687133', 'cui_str': 'Drug interaction with drug'}]",,0.0438067,"The cluster-randomised controlled study on the ""Reduction of potentially Inappropriate Medication in the Elderly"" (RIME study) is designed to examine whether an intervention based on the PRISCUS list can lower the proportion of community-dwelling people of ⩾70 years taking at least one PIM and/or medication inducing at least one dangerous DDI.","[{'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Thiem', 'Affiliation': 'Department of Medical Informatics, Biometry and Epidemiology, University of Bochum, Bochum, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wilm', 'Affiliation': 'Institute of General Practice, University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Greiner', 'Affiliation': 'Department of Health Economics and Health Care Management, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Rudolf', 'Affiliation': 'Department of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Bochum, Universitaetsstrasse 150, Bochum, 44801, Germany.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Trampisch', 'Affiliation': 'Department of Medical Informatics, Biometry and Epidemiology, University of Bochum, Bochum, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Müller', 'Affiliation': 'Department of General Practice, University Medical Centre Goettingen, Germany.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Theile', 'Affiliation': 'Klinik Susenberg, Zurich, Switzerland.'}, {'ForeName': 'Petra A', 'Initials': 'PA', 'LastName': 'Thürmann', 'Affiliation': 'Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}]",Therapeutic advances in drug safety,['10.1177/2042098620918459']
2801,32435768,Repair Bond Strength of a CAD/CAM Nanoceramic Resin and Direct Composite Resin: Effect of Aging and Surface Conditioning Methods.,"PURPOSE


To evaluate the effect of surface conditioning methods and aging on the repair bond strength between resin composite and nanoceramic CAD/CAM resin.
MATERIALS AND METHODS


Twenty-four blocks of nanoceramic CAD/CAM resin (NCR) (Lava Ultimate, 3M Oral Care) (10 x 5 x 2 mm3) and resin composite (Filtek Z350, 3M Oral Care) (RC) were made, embedded in acrylic resin, polished (#600, #800, #1200) and randomly divided into 8 groups (n = 12 each) according to surface conditioning methods (air abrasion with 30-μm CoJet [CJ] or air abrasion with 50-μm Al2O3 [AB]) and aging prior to repair (without aging, 24 h in water at 37°C; with aging 6 months in water at 37°C). The blocks were air abraded (20 s, 2.5 bar, 10 mm) using a standardized device. A layer of adhesive resin (Scotchbond Universal) was applied (20 s) and photopolymerized for 20 s. RC cylinders (Ø = 2 mm; h = 2 mm) were then bonded to the NCR substrates using a Teflon matrix and photopolymerized for 40 s. All specimens were thermocycled (10,000 cycles, 5°C-55°C) and submitted to the shear bond test (50 kgf, 0.5 mm/min) to measure repair strength. Data (MPa) were analyzed using 3-way ANOVA and Tukey's test (α = 0.05). Failure analysis was performed using stereomicroscopy (20X).
RESULTS


ANOVA revealed a significant effect of only the ""material"" factor (p = 0.00). The group NCR6mCJ presented bond strengths (29.37 ± 5.41) which were significantly higher than those of the NCR24hCJ (20.88 ± 5.74) and RC groups (p < 0.05). The group RC24hCJ (19.71 ± 4.21) presented the lowest shear bond strength (p < 0.05). Failure analysis revealed predominantly type B mixed failures (adhesive+cohesive in the substrate material) except for the groups NCR24hCJ and NCR6mAB, where mainly type C failure (adhesive+cohesive at the RC) was observed.
CONCLUSION


Air abrasion with Al2O3 particles or silicatization with CoJet followed by adhesive resin application are effective surface conditioning methods for the repair of nanoceramic CAD/CAM resin with resin composite.",2020,The group NCR6mCJ presented bond strengths (29.37 ± 5.41) which were significantly higher than those of the NCR24hCJ (20.88 ± 5.74) and RC groups (p < 0.05).,"['Twenty-four blocks of nanoceramic CAD/CAM resin (NCR) (Lava Ultimate, 3M Oral Care) (10 x 5 x 2 mm3) and resin composite (Filtek Z350, 3M Oral Care) (RC) were made, embedded in acrylic resin, polished (#600, #800, #1200']","['adhesive resin (Scotchbond Universal', 'surface conditioning methods (air abrasion with 30-μm CoJet [CJ] or air abrasion with 50-μm Al2O3 [AB]) and aging prior to repair (without aging, 24 h in water', 'NCR24hCJ']","['material"" factor', 'lowest shear bond strength']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439243', 'cui_str': 'uL'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C2606096', 'cui_str': 'filtek Z350'}, {'cui': 'C0001222', 'cui_str': 'Acrylic Resins'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C4517548', 'cui_str': '1200'}]","[{'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0074197', 'cui_str': 'Scotchbond'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",,0.0378038,The group NCR6mCJ presented bond strengths (29.37 ± 5.41) which were significantly higher than those of the NCR24hCJ (20.88 ± 5.74) and RC groups (p < 0.05).,"[{'ForeName': 'Dayanne Monielle Duarte', 'Initials': 'DMD', 'LastName': 'Moura', 'Affiliation': ''}, {'ForeName': 'Amanda Maria de Oliveira', 'Initials': 'AMO', 'LastName': 'Dal Piva', 'Affiliation': ''}, {'ForeName': 'Ana Beatriz do Nascimento', 'Initials': 'ABDN', 'LastName': 'Januário', 'Affiliation': ''}, {'ForeName': 'Aretha Heitor', 'Initials': 'AH', 'LastName': 'Verissímo', 'Affiliation': ''}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Bottino', 'Affiliation': ''}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Özcan', 'Affiliation': ''}, {'ForeName': 'Rodrigo Othávio Assunção', 'Initials': 'ROA', 'LastName': 'Souza', 'Affiliation': ''}]",The journal of adhesive dentistry,['10.3290/j.jad.a44551']
2802,32105355,Cost-Effectiveness of Pharmacist-Led Deprescribing of NSAIDs in Community-Dwelling Older Adults.,"OBJECTIVES


Older adults are often prescribed potentially inappropriate medications associated with adverse health outcomes and increased health services utilization. Developing Pharmacist-led Research to Educate and Sensitize Community Residents to the Inappropriate Prescriptions Burden in the Elderly (D-PRESCRIBE), a pragmatic randomized clinical trial, demonstrated how a community pharmacist-led evidence-based educational intervention successfully empowered community-dwelling older adults and their physicians to reduce chronic use of inappropriate medications. The objective of this study was to evaluate the cost-effectiveness of the D-PRESCRIBE intervention for discontinuing nonsteroidal anti-inflammatory drugs (NSAIDs).
DESIGN


Cost-effectiveness analysis.
SETTING


Canada.
PARTICIPANTS


Community-dwelling adults aged 65 years and older.
MEASUREMENTS


Decision analysis combining decision tree and Markov state transition modeling was developed to estimate the cost-effectiveness of D-PRESCRIBE (NSAIDs) compared with usual care from a Canadian healthcare system perspective with a time horizon of 1 year. Data from the D-PRESCRIBE trial and published literature were used to calculate effectiveness, utilities, and costs. Reference case and scenario analyses were conducted using probabilistic modeling. Sensitivity analyses assessed the robustness of the reference case model.
RESULTS


D-PRESCRIBE (NSAIDs) was less costly (-$1008.61) and more effective (.11 quality-adjusted life-years [QALYs]) than usual care and was the dominant strategy. At willingness-to-pay thresholds of $50 000 per QALY and $100 000 per QALY, D-PRESCRIBE (NSAIDs) incurred a positive incremental net benefit compared with usual care, suggesting it is cost-effective. Compared with the reference case, scenario analyses gave comparable QALYs with modest variation in cost estimates.
CONCLUSION


For community-dwelling older adults, D-PRESCRIBE (NSAIDs) provides greater benefits at lower system costs, making it a compelling strategy to reduce the use and harms associated with chronic NSAID consumption. Our findings support reimbursing community pharmacists' clinical professional services for deprescribing inappropriate NSAIDs in community-dwelling older adults. J Am Geriatr Soc 68:1090-1097, 2020.",2020,"CONCLUSION


For community-dwelling older adults, D-PRESCRIBE (NSAIDs) provides greater benefits at lower system costs, making it a compelling strategy to reduce the use and harms associated with chronic NSAID consumption.","['Community-dwelling adults aged 65 years and older', 'Community-Dwelling Older Adults', 'community-dwelling older adults', 'Older adults', 'Canada']",['Pharmacist-Led Deprescribing of NSAIDs'],['cost-effectiveness'],"[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0767756,"CONCLUSION


For community-dwelling older adults, D-PRESCRIBE (NSAIDs) provides greater benefits at lower system costs, making it a compelling strategy to reduce the use and harms associated with chronic NSAID consumption.","[{'ForeName': 'Chiranjeev', 'Initials': 'C', 'LastName': 'Sanyal', 'Affiliation': 'Canadian Pharmacists Association, Ottawa, Ontario, Canada.'}, {'ForeName': 'Justin P', 'Initials': 'JP', 'LastName': 'Turner', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Tannenbaum', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16388']
2803,32435766,Bonding Performance of Simplified Dental Adhesives with Three Application Protocols: An 18-month In Vitro Study.,"PURPOSE


To evaluate the influence of application protocol on the shear bond strength (SBS) and nanoleakage of simplified adhesives over 18 months.
MATERIALS AND METHODS


810 dentin slices were obtained from 405 caries-free human molars. They were randomly assigned to 54 experimental groups resulting from the combination of ""adhesive"" (Adper Scotchbond 1XT [S1XT], Solobond M [SM], Scotchbond Universal Adhesive in etch-and-rinse mode [SUER] and self-etch mode [SUSE], Adper Easy Bond [EB], Clearfil S3 Bond Plus [CS3]), ""application protocol"" (manufacturer's instructions [MI], two extra layers of adhesive [EL], hydrophobic resin layer [HL]), and ""aging time"" (24 h [24H], 6 months [6M], and 18 months [18M] in water). SBS tests were carried out using a Watanabe device followed by failure mode analysis. For the nanoleakage study, specimens from 54 additional molars were prepared as previously described, immersed in ammoniacal silver nitrate, and evaluated with SEM. SBS data were analyzed with ANOVA followed by Tukey's post-hoc tests; failure mode data were analyzed using chi-squared tests (α = 0.05). Nanoleakage data were analyzed with the Kruskal-Wallis test followed by LSD tests (α = 0.05).
RESULTS


After 18M, S1XT and SUSE achieved the highest mean SBS (p < 0.05). Regarding the application protocols, EL and HL provided higher mean SBS than those obtained with MI (p < 0.05). HL resulted in the highest mean SBS and the lowest mean nanoleakage after 18M.
CONCLUSION


Simplified adhesives may need an extra hydrophobic resin layer to achieve a stable and durable adhesive interface. The self-etch approach should be recommended for the universal adhesive.",2020,"After 18M, S1XT and SUSE achieved the highest mean SBS (p < 0.05).",['810 dentin slices were obtained from 405 caries-free human molars'],"['adhesive"" (Adper Scotchbond 1XT [S1XT], Solobond M [SM], Scotchbond Universal Adhesive in etch-and-rinse mode [SUER] and self-etch mode [SUSE], Adper Easy Bond [EB], Clearfil S3 Bond Plus [CS3]), ""application protocol"" (manufacturer\'s instructions [MI], two extra layers of adhesive [EL], hydrophobic resin layer [HL']","['shear bond strength (SBS) and nanoleakage of simplified adhesives', 'highest mean SBS', 'mean SBS', 'SBS data']","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0074197', 'cui_str': 'Scotchbond'}, {'cui': 'C0966119', 'cui_str': 'Solobond M'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3711495', 'cui_str': 'easy bond'}, {'cui': 'C1678488', 'cui_str': 'Clearfil S3 Bond'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",810.0,0.0240653,"After 18M, S1XT and SUSE achieved the highest mean SBS (p < 0.05).","[{'ForeName': 'Ana Filipa', 'Initials': 'AF', 'LastName': 'Chasqueira', 'Affiliation': ''}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Arantes-Oliveira', 'Affiliation': ''}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Portugal', 'Affiliation': ''}]",The journal of adhesive dentistry,['10.3290/j.jad.a44549']
2804,32435764,Clinical Performance of a Glass-Hybrid System Compared with a Resin Composite in the Posterior Region: Results of a 2-year Multicenter Study.,"PURPOSE


To compare the clinical performance of a glass hybrid restorative system, EQUIA Forte, with that of a nanohybrid resin composite, Tetric EvoCeram, in two-surface class II cavities.
MATERIALS AND METHODS


This multicenter, randomized controlled clinical study was conducted at four different dental schools. In total, 360 restorations were placed in patients in need of two class-II, two-surface restorations in the molar region of the same jaw. Each patient received one glass hybrid restoration (EQUIA Forte, GC) and one resin composite restoration (Tetric EvoCeram, Ivoclar Vivadent). Two independent evaluators performed a clinical evaluation of each site after 1 week (baseline), 1 year, and 2 years using the criteria of the FDI World Dental Federation (FDI-2).
RESULTS


The estimated survival rates at the 2-year recall were 93.6% and 94.5% for EQUIA Forte and Tetric EvoCeram, respectively. There were no significant differences in the survival rates or in any of the evaluated esthetic, functional or biological properties between EQUIA Forte and Tetric EvoCeram restorations (p ˃ 0.05).
CONCLUSION


Both the glass-hybrid restorative system and nanohybrid resin composite showed good clinical performance in moderate to large two-surface class II restorations in a 2-year follow-up.",2020,"There were no significant differences in the survival rates or in any of the evaluated esthetic, functional or biological properties between EQUIA Forte and Tetric EvoCeram restorations (p ˃ 0.05).
","['four different dental schools', 'In total, 360 restorations were placed in patients in need of two class-II, two-surface restorations in the molar region of the same jaw']","['glass hybrid restorative system, EQUIA Forte', 'Glass-Hybrid System Compared with a Resin Composite', 'glass hybrid restoration (EQUIA Forte, GC) and one resin composite restoration (Tetric EvoCeram, Ivoclar Vivadent']","['good clinical performance', 'evaluated esthetic, functional or biological properties', 'survival rates', 'estimated survival rates']","[{'cui': 'C0036376', 'cui_str': 'Dental School'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C1570772', 'cui_str': 'Tetric EvoCeram'}, {'cui': 'C0124269', 'cui_str': 'Ivoclar'}, {'cui': 'C0148539', 'cui_str': 'Vivadent'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",360.0,0.0596878,"There were no significant differences in the survival rates or in any of the evaluated esthetic, functional or biological properties between EQUIA Forte and Tetric EvoCeram restorations (p ˃ 0.05).
","[{'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Miletić', 'Affiliation': ''}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Baraba', 'Affiliation': ''}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Basso', 'Affiliation': ''}, {'ForeName': 'Maria Giulia', 'Initials': 'MG', 'LastName': 'Pulcini', 'Affiliation': ''}, {'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Marković', 'Affiliation': ''}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Perić', 'Affiliation': ''}, {'ForeName': 'Cigdem Atalayin', 'Initials': 'CA', 'LastName': 'Ozkaya', 'Affiliation': ''}, {'ForeName': 'Lezize Sebnem', 'Initials': 'LS', 'LastName': 'Turkun', 'Affiliation': ''}]",The journal of adhesive dentistry,['10.3290/j.jad.a44547']
2805,31170712,Effects of Bardoxolone Methyl on Magnesium in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease.,"BACKGROUND


Treatment with bardoxolone methyl (Bard) in a multinational phase 3 trial, Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes (BEACON), resulted in increases in estimated glomerular filtration rate with concurrent reductions in serum magnesium. We analyzed data from several trials to characterize reductions in magnesium with Bard.
METHODS


BEACON randomized patients (n = 2,185) with type 2 diabetes (T2DM) and stage 4 chronic kidney disease (CKD) 1:1 to receive Bard (20 mg) or placebo once daily. In a separate open-label study, magnesium levels from 24-hour urine and sublingual epithelial cell samples were analyzed in patients with stage 3b-4 CKD and T2DM administered 20 mg Bard for 56 consecutive days.
RESULTS


BEACON patients randomized to Bard experienced significant reductions in serum magnesium from baseline relative to patients randomized to placebo (-0.17 mEq/L, 95% CI -0.18 to -0.60 mEq/L; p < 0.001). A separate study showed intracellular and urinary magnesium levels were unchanged with Bard treatment.
CONCLUSIONS


Bard treatment results in significant decreases in serum magnesium that are not associated with changes in intracellular and urinary magnesium levels, indicating that magnesium decreases are not due to renal magnesium wasting or total body magnesium depletion. Importantly, the decreases in serum magnesium with Bard are not associated with adverse effects on QT interval.",2019,"Bard treatment results in significant decreases in serum magnesium that are not associated with changes in intracellular and urinary magnesium levels, indicating that magnesium decreases are not due to renal magnesium wasting or total body magnesium depletion.","['Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease', 'patients with stage 3b-4 CKD and T2DM administered 20 mg Bard for 56 consecutive days', 'Patients with Chronic Kidney Disease and Type 2 Diabetes (BEACON', 'randomized patients (n = 2,185) with type 2 diabetes (T2DM) and stage 4 chronic kidney disease (CKD) 1:1 to receive Bard (20 mg) or']","['Magnesium', 'Bardoxolone Methyl', 'placebo', 'bardoxolone methyl (Bard', 'Bardoxolone Methyl Evaluation']","['intracellular and urinary magnesium levels', 'serum magnesium', 'renal magnesium wasting or total body magnesium depletion', 'glomerular filtration rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0457164', 'cui_str': 'Stage 3b'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}]","[{'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C1100924', 'cui_str': 'methyl 2-cyano-3,12-dioxoolean-1,9-dien-28-oate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0373675', 'cui_str': 'Magnesium measurement (procedure)'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum (procedure)'}, {'cui': 'C1835171', 'cui_str': 'Hypomagnesemia 2, renal'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",2185.0,0.247887,"Bard treatment results in significant decreases in serum magnesium that are not associated with changes in intracellular and urinary magnesium levels, indicating that magnesium decreases are not due to renal magnesium wasting or total body magnesium depletion.","[{'ForeName': 'Dana V', 'Initials': 'DV', 'LastName': 'Rizk', 'Affiliation': 'Department of Medicine, Nephrology Division, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Arnold L', 'Initials': 'AL', 'LastName': 'Silva', 'Affiliation': 'Boise Kidney and Hypertension Institute, Meridian, Idaho, USA.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Pergola', 'Affiliation': 'Renal Associates PA, San Antonio, Texas, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Toto', 'Affiliation': 'Internal Medicine and Clinical Science, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Warnock', 'Affiliation': 'Department of Medicine, Nephrology Division, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Melanie P', 'Initials': 'MP', 'LastName': 'Chin', 'Affiliation': 'Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'Angie', 'Initials': 'A', 'LastName': 'Goldsberry', 'Affiliation': 'Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': ""O'Grady"", 'Affiliation': 'Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Meyer', 'Affiliation': 'Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'McCullough', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor Jack and Jane Hamilton Heart and Vascular Hospital, The Heart Hospital, Baylor University Medical Center, Dallas, Texas, USA, peteramccullough@gmail.com.'}]",Cardiorenal medicine,['10.1159/000500612']
2806,32435860,Effectiveness of a Module Based Training on Nurses' Attitude Towards Social Norms and Beliefs That Support Abuse Among women with Mental Illness.,"Violence against women is a priority public health issue. Women with mental illness are at a double disadvantage. While social norms and beliefs either support or confront violence against women, research is limited on this issue. A randomized controlled design was adopted for the present study. This study was aimed to evaluate the effectiveness of module-based training in changing nurses' attitudes towards norms and beliefs that support violence against women in mental health care settings. In this study, 68 nurses were randomly assigned to either the experimental or control group (34 in each group). After receiving the training program, the mean scores on norms and beliefs and justifiability of abuse scales were significantly higher in the experimental group compared to the control group (p < 0.05). The results confirmed the positive impact of the training program in changing nurses' attitudes. However, further studies are required to draw firm conclusions on the effectiveness of the training intervention.",2020,"After receiving the training program, the mean scores on norms and beliefs and justifiability of abuse scales were significantly higher in the experimental group compared to the control group (p < 0.05).","['women with Mental Illness', '68 nurses', 'Women with mental illness', 'violence against women in mental health care settings', 'Violence against women']","['Module Based Training', 'module-based training']","[""Nurses' Attitude Towards Social Norms and Beliefs"", 'mean scores on norms and beliefs and justifiability of abuse scales']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}]","[{'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",68.0,0.0484071,"After receiving the training program, the mean scores on norms and beliefs and justifiability of abuse scales were significantly higher in the experimental group compared to the control group (p < 0.05).","[{'ForeName': 'Poreddi', 'Initials': 'P', 'LastName': 'Vijayalakshmi', 'Affiliation': 'College of Nursing, National Institute of Mental Health and Neuro Sciences, Institute of National Importance, Bangalore, 560029, India. pvijayalakshmireddy@gmail.com.'}, {'ForeName': 'Gandhi', 'Initials': 'G', 'LastName': 'Sailaxmi', 'Affiliation': 'Department of Nursing, National Institute of Mental Health and Neuro Sciences, Institute of National Importance, Bangalore, India.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Nikhil Reddy', 'Affiliation': 'Bangalore Medical College and Research Institute, Bangalore, 560029, India.'}, {'ForeName': 'Palaniappan', 'Initials': 'P', 'LastName': 'Marimuthu', 'Affiliation': 'Department of Bio-Statistics, National Institute of Mental Health and Neuro Sciences, Institute of National Importance, Bangalore, India.'}, {'ForeName': 'Bada Math', 'Initials': 'BM', 'LastName': 'Suresh', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Institute of National Importance, Bangalore, India.'}]",Community mental health journal,['10.1007/s10597-020-00628-1']
2807,32435772,Effect of Crosslinked Chitosan Nanoparticles on the Bonding Quality of Fiber Posts in Root Canals.,"PURPOSE


To investigate the effects of root-canal dentin pretreatment with the crosslinker EDC combined with chitosan nanoparticles (Csnp) on the bonding quality of fiber posts in root canals in terms of bond strength, nanoleakage, quantification of collagen degradation, and degree of conversion (DC) of adhesive.
MATERIALS AND METHODS


Forty-eight single-rooted teeth were prepared endodontically and etched using UNI-ETCH (Bisco) as per the adhesive procedure for fiber posts. They were randomly divided into three groups before adhesive (All-Bond 3) application, according to different pretreatments: a. immersed in 2.5% glutaraldehyde for 24 h; b. treated with Csnp solution under ultrasonic agitation for 60 s and immersed in EDC crosslinker for 24 h; c. without treatment (control). Bond strength, nanoleakage, DC within the interface, and collagen fiber degradation were evaluated.
RESULTS


The pretreatments had a significant influence on the bonding stability of fiber posts in root canals, but not on the degree of conversion (p = 0.552). Enzymatic degradation significantly influenced bond strength for all groups (p = 0.001), with the greatest effect found in group c. The amount of amino acids released from the adhesive interface differed significantly between groups after hydrolysis and enzymatic degradation (p = 0.000); group c released the highest amount of amino acids.
CONCLUSIONS


Csnp binding to dentin in combination with EDC reduced degradation of dentinal collagen and improved the stability of the adhesive interface without jeopardizing adhesive polymerization.",2020,"Enzymatic degradation significantly influenced bond strength for all groups (p = 0.001), with the greatest effect found in group c.","['Forty-eight single-rooted teeth', 'Fiber Posts in Root Canals']","['Csnp solution under ultrasonic agitation for 60 s and immersed in EDC crosslinker for 24 h; c. without treatment (control', 'Crosslinked Chitosan Nanoparticles', 'root-canal dentin pretreatment with the crosslinker EDC combined with chitosan nanoparticles (Csnp', 'UNI-ETCH (Bisco']","['bond strength, nanoleakage, quantification of collagen degradation, and degree of conversion (DC) of adhesive', 'Bond strength, nanoleakage, DC within the interface, and collagen fiber degradation', 'bond strength', 'bonding stability of fiber posts', 'degradation of dentinal collagen']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}]","[{'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0015081', 'cui_str': '1,2-dichloroethane'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1311388', 'cui_str': 'Uni-Etch'}, {'cui': 'C1100963', 'cui_str': 'bis(terpyridine)cobalt(II) chloride'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0225325', 'cui_str': 'Collagen fiber'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",,0.0194099,"Enzymatic degradation significantly influenced bond strength for all groups (p = 0.001), with the greatest effect found in group c.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': ''}, {'ForeName': 'Lipei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Qingsong', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Kishen', 'Affiliation': ''}]",The journal of adhesive dentistry,['10.3290/j.jad.a44555']
2808,31345778,"Norursodeoxycholic acid versus placebo in the treatment of non-alcoholic fatty liver disease: a double-blind, randomised, placebo-controlled, phase 2 dose-finding trial.","BACKGROUND


Norursodeoxycholic acid is an orally administered side chain-shortened homologue of ursodeoxycholic acid that undergoes hepatic enrichment with hepatoprotective, anti-inflammatory, and antifibrotic activity. We assessed the efficacy of two doses of norursodeoxycholic acid versus placebo for the treatment of non-alcoholic fatty liver disease.
METHODS


We did a multicentre, double-blind, placebo-controlled, randomised, phase 2 dose-finding clinical trial in tertiary referral hospitals and medical centres in Austria (n=6) and Germany (n=23) for patients with non-alcoholic fatty liver disease with or without diabetes. Patients with a clinical diagnosis of non-alcoholic fatty liver disease and serum alanine aminotransferase (ALT) concentrations of more than 0·8 times the upper limit of normal were randomly assigned (1:1:1) using a computer-generated central randomisation. Patients were randomly assigned to receive either norursodeoxycholic acid capsules at 500 mg per day or 1500 mg per day, or placebo, for 12 weeks with a subsequent 4-week follow-up period. All individuals involved in the trial were masked to treatment allocation. The primary efficacy endpoint was the mean relative percentage change in ALT concentrations between baseline and end of treatment assessed in the intention-to-treat population. This trial is registered with EudraCT, number 2013-004605-38.
FINDINGS


Between March 30, 2015, and Sept 20, 2016, of 198 individuals included in the analysis, 67 patients were randomly assigned to receive 500 mg norursodeoxycholic acid, 67 to 1500 mg norursodeoxycholic acid, and 64 to placebo. A dose-dependent reduction in serum ALT between baseline and end of treatment was observed with norursodeoxycholic acid versus placebo, with a significant effect in the 1500 mg group (mean change -27·8%, 95% repeated CI -34·7 to -14·4; p<0·0001). Serious adverse events (n=6) and treatment-emergent adverse events (n=314) were reported in a similar proportion of patients across groups. 112 treatment-emergent adverse events occurred in the 1500 mg group, 99 in the 500 mg group, and 103 in the placebo group. The most frequent adverse events were headache, gastrointestinal disorders, and infections (eg, diarrhoea, abdominal pain, or nasopharyngitis).
INTERPRETATION


Norursodeoxycholic acid at 1500 mg resulted in a significant reduction of serum ALT within 12 weeks of treatment when compared with placebo. Norursodeoxycholic acid was safe and well tolerated encouraging further studies.
FUNDING


Dr Falk Pharma GmbH.",2019,Norursodeoxycholic acid at 1500 mg resulted in a significant reduction of serum ALT within 12 weeks of treatment when compared with placebo.,"['Between March 30, 2015, and Sept 20, 2016, of 198 individuals included in the analysis, 67 patients', 'non-alcoholic fatty liver disease', 'tertiary referral hospitals and medical centres in Austria (n=6) and Germany (n=23) for patients with non-alcoholic fatty liver disease with or without diabetes', 'Patients with a clinical diagnosis of non-alcoholic fatty liver disease and serum alanine aminotransferase (ALT) concentrations of more than 0·8 times the upper limit of normal']","['norursodeoxycholic acid, and 64 to placebo', 'Norursodeoxycholic acid', 'placebo', 'norursodeoxycholic acid', 'ursodeoxycholic acid', 'norursodeoxycholic acid capsules', 'norursodeoxycholic acid versus placebo', 'Norursodeoxycholic acid versus placebo']","['headache, gastrointestinal disorders, and infections (eg, diarrhoea, abdominal pain, or nasopharyngitis', 'serum ALT', 'adverse events', 'mean relative percentage change in ALT concentrations', 'Serious adverse events (n=6) and treatment-emergent adverse events']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",112.0,0.730487,Norursodeoxycholic acid at 1500 mg resulted in a significant reduction of serum ALT within 12 weeks of treatment when compared with placebo.,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Traussnigg', 'Affiliation': 'Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Jörn M', 'Initials': 'JM', 'LastName': 'Schattenberg', 'Affiliation': 'Department of Internal Medicine I, University Medical Center of the Johannes-Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Münevver', 'Initials': 'M', 'LastName': 'Demir', 'Affiliation': 'Clinic for Gastroenterology and Hepatology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Wiegand', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Geier', 'Affiliation': 'Department of Medicine II, Division of Hepatology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Gerlinde', 'Initials': 'G', 'LastName': 'Teuber', 'Affiliation': 'Teuber Consulting & Research UG, Frankfurt, Germany.'}, {'ForeName': 'Wolf Peter', 'Initials': 'WP', 'LastName': 'Hofmann', 'Affiliation': 'Practice for Gastroenterology, Berlin, Germany.'}, {'ForeName': 'Andreas E', 'Initials': 'AE', 'LastName': 'Kremer', 'Affiliation': 'Department of Medicine I, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Spreda', 'Affiliation': 'Practice of Hadem/Spreda, Daaden, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kluwe', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology and Hepatology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Petersen', 'Affiliation': 'Ifi-Studies and Projects at the Asklepios Clinic St Georg, Hamburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Boettler', 'Affiliation': 'Department of Medicine II, Medical CenterFaculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rainer', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology and Hepatology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Emina', 'Initials': 'E', 'LastName': 'Halilbasic', 'Affiliation': 'Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Greinwald', 'Affiliation': 'Dr Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pröls', 'Affiliation': 'Dr Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Manns', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fickert', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology and Hepatology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trauner', 'Affiliation': 'Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University Vienna, Vienna, Austria. Electronic address: michael.trauner@meduniwien.ac.at.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30184-0']
2809,32436173,Evaluation of biochemical and clinical effects of hyaluronic acid on non-surgical periodontal treatment: a randomized controlled trial.,"BACKGROUND


Recent studies reported that hyaluronic acid (HA) has anti-inflammatory, anti-edematous, and anti-bacterial activities in dentistry, particularly in gingival disorders caused by subgingival plaque microorganisms.
AIMS


This study aimed to evaluate the early term effects of HA as an adjunct to scaling and root planing (SRP) on clinical parameters, periodontal inflamed surface area (PISA), and adenosine deaminase (ADA), catalase (CAT), and glutathione (GSH) levels in gingival crevicular fluid (GCF) in periodontitis.
METHODS


A total of 24 periodontitis patients per group were included in this randomized-controlled study. The study population was divided into four groups: in Group 1: SRP+ saline; in Group 2: SRP + HA gel; in Group 3: SRP+ HA mouth rinse; and in Group 4: SRP + HA mouth rinse + HA gingival gel were applied. At baseline and week 4, clinical parameters and PISA were calculated. Also, biochemicals' (ADA, CAT, and GSH) levels were determined by spectrophotometric analysis.
RESULTS


There was a statistically significant improvement in clinical parameters and PISA in all four groups in control sessions (p < 0.05). There was a significant decrease in ADA in GCF and significant increases in CAT and GSH levels after SRP (p < 0.05) in all four groups. The groups that were administered only gel (2nd and 4th) were different from other groups in terms of ADA, CAT, and GSH levels at 1st week (p < 0.05).
CONCLUSION


HA application as an adjunct to SRP did not affect the clinical results, although, in the control sessions following the application, the results were favorable for the biochemical data in gel-applied groups.
TRIAL REGISTRATION


ClinicalTrials.gov.tr (NCT03754010).",2020,There was a statistically significant improvement in clinical parameters and PISA in all four groups in control sessions (p < 0.05).,['24 periodontitis patients per group'],"['SRP+ saline', 'hyaluronic acid (HA', 'SRP\u2009+\u2009HA mouth rinse + HA gingival gel', 'HA', 'scaling and root planing (SRP', 'hyaluronic acid', 'SRP+ HA mouth rinse', 'SRP\u2009+\u2009HA gel']","[""biochemicals' (ADA, CAT, and GSH) levels"", 'clinical parameters, periodontal inflamed surface area (PISA), and adenosine deaminase (ADA), catalase (CAT), and glutathione (GSH) levels in gingival crevicular fluid (GCF', 'clinical parameters and PISA', 'CAT and GSH levels', 'ADA in GCF', 'ADA, CAT, and GSH levels']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C1276322', 'cui_str': 'Gingival gel'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}]",24.0,0.0471752,There was a statistically significant improvement in clinical parameters and PISA in all four groups in control sessions (p < 0.05).,"[{'ForeName': 'Hacer Sahin', 'Initials': 'HS', 'LastName': 'Aydinyurt', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Van Yuzuncu Yil University, Campus, 65080, Van, Turkey. hacersahinay@gmail.com.tr.'}, {'ForeName': 'Damla', 'Initials': 'D', 'LastName': 'Akbal', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Van Yuzuncu Yil University, Campus, 65080, Van, Turkey.'}, {'ForeName': 'Dicle', 'Initials': 'D', 'LastName': 'Altindal', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Van Yuzuncu Yil University, Campus, 65080, Van, Turkey.'}, {'ForeName': 'Alihan', 'Initials': 'A', 'LastName': 'Bozoglan', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Firat University, Elazig, Turkey.'}, {'ForeName': 'Abdullah Seckin', 'Initials': 'AS', 'LastName': 'Ertugrul', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Halit', 'Initials': 'H', 'LastName': 'Demir', 'Affiliation': 'Faculty of Art and Science, Department of Chemistry, Van Yuzuncu Yil University, Van, Turkey.'}]",Irish journal of medical science,['10.1007/s11845-020-02230-6']
2810,32436244,A multicenter phase II trial of nab-paclitaxel and capecitabine in HER-2 negative and triple- negative advanced breast cancer: Could be an old regimen a valid approach to a changing disease?,,2020,,['HER-2 negative and triple- negative advanced breast cancer'],['nab-paclitaxel and capecitabine'],[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]",[],,0.0133809,,"[{'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Ciccarese', 'Affiliation': 'Division of Medical Oncology & Breast Unit, Ospedale ""Vito Fazzi"", Lecce, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Orlando', 'Affiliation': 'Medical Oncology & Breast Unit, Ospedale ""A. Perrino"", Brindisi, Italy.'}, {'ForeName': 'Palma', 'Initials': 'P', 'LastName': 'Fedele', 'Affiliation': 'Medical Oncology & Breast Unit, Ospedale ""A. Perrino"", Brindisi, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Schiavone', 'Affiliation': 'Medical Oncology & Breast Unit, Ospedale ""A. Perrino"", Brindisi, Italy.'}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Oncology Unit, IRCCS ""Casa Sollievo della Sofferenza"", S. Giovanni Rotondo, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Cilenti', 'Affiliation': 'Oncology Unit, IRCCS ""Casa Sollievo della Sofferenza"", S. Giovanni Rotondo, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Aieta', 'Affiliation': 'Division of Medical Oncology, IRCCS, Rionero in Vulture, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Bozza', 'Affiliation': 'Division of Medical Oncology, IRCCS, Rionero in Vulture, Italy.'}, {'ForeName': 'Rosachiara', 'Initials': 'R', 'LastName': 'Forcignanò', 'Affiliation': 'Division of Medical Oncology & Breast Unit, Ospedale ""Vito Fazzi"", Lecce, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Febbraro', 'Affiliation': 'Oncology, Fatebenefratelli Hospital, Benevento, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bordonaro', 'Affiliation': 'Division of Medical Oncology, ARNAS Garibaldi, Catania, Italy.'}, {'ForeName': 'Sante', 'Initials': 'S', 'LastName': 'Romito', 'Affiliation': 'Division of Medical Oncology, ""Ospedali Riuniti"", Foggia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rinaldi', 'Affiliation': 'Division of Medical Oncology, ""Presidio OspedalieroOccidentale"", Castellaneta, Italy.'}, {'ForeName': ""Nicolo'"", 'Initials': 'N', 'LastName': 'Borsellino', 'Affiliation': 'Division of Medical Oncology, ""Buccheri La Ferla-Fatebenefratelli"" Hospital, Palermo, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Riccardi', 'Affiliation': 'Division of Medical Oncology, ""Cardarelli"" Hospital, Napoli, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Pisconti', 'Affiliation': 'Division of Medical Oncology, ""SG Moscati"" Hospital, Taranto, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Lorusso', 'Affiliation': 'Medical Oncology, IRCCS Ospedale Oncologico Giovanni Paolo II, Bari, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Medical Oncology, IRCCS Ospedale Oncologico Giovanni Paolo II, Bari, Italy.'}, {'ForeName': 'Giammarco', 'Initials': 'G', 'LastName': 'Surico', 'Affiliation': 'Oncology Unit, Ospedale Generale ""F. Miulli"", Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Saracino', 'Affiliation': 'Division of Medical Oncology & Breast Unit, Ospedale ""Vito Fazzi"", Lecce, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Medical Oncology & Breast Unit, Ospedale ""A. Perrino"", Brindisi, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The breast journal,['10.1111/tbj.13856']
2811,32435906,Evaluation of the effects of photobiomodulation therapy and ozone applications after gingivectomy and gingivoplasty on postoperative pain and patients' oral health-related quality of life.,"The aim of this study was to evaluate the effects of photobiomodulation therapy (PBM) and ozone applications on patients' quality of life after gingivectomy and gingivoplasty. In this study, 36 patients with chronic inflammatory gingival enlargement underwent gingivectomy and gingivoplasty. The groups were randomly divided into control (n = 12), PBM (n = 12) and ozone (n = 12) groups. GaAlAs diode laser 810 nm wavelength at a non-contact and continuous mode with a power of 0.3 W and a density of 4 J/cm 2  used for PBM for 1 min. Ozone was applied for 1 min for every 5 mm 2  in contact mode at power level 9 using probe number 3. PBM and ozone applications were performed immediately after the operation, on the 3rd and 7th days. Pain assessment was performed at 3rd, 7th, 14th and 28th days after gingivectomy and gingivoplasty by using visual analogue scale (VAS). Oral Health Impact Profile (OHIP-14) records were obtained from the patients before gingivectomy and gingivoplasty and postoperative 7th and 14th days. OHIP-14 questions were also evaluated individually. VAS pain levels of the control group measured on the 3rd day were higher than the PBM group and on the 7th day were found to be significantly higher than both groups (p < 0.05). The total OHIP-14 score of the control group on the 7th postoperative day was found to be higher than the PBM group (p < 0.05). The mean score obtained from the third question of OHIP-14 at 7th and 14th day of the PBM group was found to be lower than the control and ozone groups (p < 0.05). The PBM and ozone applications after gingivectomy and gingivoplasty reduce the pain levels of patients and have a positive effect on patients' quality of life.",2020,VAS pain levels of the control group measured on the 3rd day were higher than the PBM group and on the 7th day were found to be significantly higher than both groups (p < 0.05).,"[""patients' quality of life after gingivectomy and gingivoplasty"", '36 patients with chronic inflammatory gingival enlargement underwent gingivectomy and gingivoplasty']","['photobiomodulation therapy and ozone applications after gingivectomy and gingivoplasty', 'GaAlAs diode laser 810', 'photobiomodulation therapy (PBM) and ozone applications', 'PBM']","[""postoperative pain and patients' oral health-related quality of life"", 'pain levels', 'total OHIP-14 score', 'Pain assessment', 'VAS pain levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0017573', 'cui_str': 'Gingivectomy'}, {'cui': 'C0017576', 'cui_str': 'Gingivoplasty'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0017566', 'cui_str': 'Hyperplasia of gingiva'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0017573', 'cui_str': 'Gingivectomy'}, {'cui': 'C0017576', 'cui_str': 'Gingivoplasty'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",36.0,0.014578,VAS pain levels of the control group measured on the 3rd day were higher than the PBM group and on the 7th day were found to be significantly higher than both groups (p < 0.05).,"[{'ForeName': 'Mustafa Özay', 'Initials': 'MÖ', 'LastName': 'Uslu', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Inonu University, 44280, Malatya, Turkey. mustafaozayuslu@hotmail.com.'}, {'ForeName': 'Semih', 'Initials': 'S', 'LastName': 'Akgül', 'Affiliation': 'Malatya Şehit Mehmet Kılınç Oral And Dental Health Hospital, 44280, Malatya, Turkey.'}]",Lasers in medical science,['10.1007/s10103-020-03037-8']
2812,32435878,Remote Peer Learning Between US and Cambodian Lay Health Workers to Improve Outcomes for Cambodians with Type 2 Diabetes: a Pilot Study.,"BACKGROUND


This paper reports a single-group, pre-post pilot of a peer-learning intervention between community health workers (CHWs) in the USA and Village Health Support Guides (Guides) in Cambodia to improve outcomes for Cambodians with type 2 diabetes (T2D).
METHOD


Two US-based CHWs were trained in a culturally derived cardiometabolic education curriculum called Eat, Walk, Sleep (EWS) and they were also trained in principles of peer learning. They in turn trained five Cambodia-based Guides remotely through videoconference with a phablet in EWS. Finally, Cambodia-based Guides met with 58 patients with diabetes, face-to-face in their villages, monthly for 6 months to deliver EWS. US-based CHWs and Cambodia-based Guides responded to surveys at baseline and post-treatment. Patients responded to surveys and provided blood pressure and blood samples at baseline and post-treatment.
RESULTS


For US-based CHWs, scores on all surveys of diabetes knowledge, self-evaluation, job satisfaction, and information technology improved, though no statistical tests were run due to sample size. For Cambodia-based Guides, all scores on these same measures improved except for job satisfaction. For patients, n = 60 consented, 2 withdrew, and 7 were lost to follow-up leaving n = 51 for analysis. In paired t tests, patients showed significantly decreased A1c, decreased systolic and diastolic blood pressures, improved attitudes toward medicines, and a trend for switching from all-white to part-brown rice. No changes were detected in self-reported physical activity, medication adherence, sleep quality, or frequency or amount of rice consumed.
CONCLUSION


If proven effective in a controlled trial, cross-country peer learning could eventually help other diaspora communities.",2020,"No changes were detected in self-reported physical activity, medication adherence, sleep quality, or frequency or amount of rice consumed.
","['Cambodian Lay Health Workers', 'Cambodians with Type 2 Diabetes', '58 patients with diabetes', 'Cambodians with type 2 diabetes (T2D']","['peer-learning intervention', 'culturally derived cardiometabolic education curriculum called Eat, Walk, Sleep (EWS) and they were also trained in principles of peer learning']","['systolic and diastolic blood pressures, improved attitudes toward medicines', 'self-reported physical activity, medication adherence, sleep quality, or frequency or amount of rice consumed', 'diabetes knowledge, self-evaluation, job satisfaction, and information technology', 'blood pressure and blood samples']","[{'cui': 'C1553323', 'cui_str': 'Cambodians'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0021423', 'cui_str': 'Information Sciences'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.0231657,"No changes were detected in self-reported physical activity, medication adherence, sleep quality, or frequency or amount of rice consumed.
","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Wagner', 'Affiliation': 'University of Connecticut Schools of Dental Medicine and Medicine, 263 Farmington Ave., MC3910, Farmington, CT, 06030, USA. juwagner@uchc.edu.'}, {'ForeName': 'S Megan', 'Initials': 'SM', 'LastName': 'Berthold', 'Affiliation': 'University of Connecticut School of Social Work, Hartford, CT, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Buckley', 'Affiliation': 'University of Connecticut School of Pharmacy, Storrs, CT, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bermudez-Millan', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Toan', 'Initials': 'T', 'LastName': 'Ha', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Scully', 'Affiliation': 'Khmer Health Advocates, West Hartford, CT, USA.'}, {'ForeName': 'Theanvy', 'Initials': 'T', 'LastName': 'Kuoch', 'Affiliation': 'Khmer Health Advocates, West Hartford, CT, USA.'}, {'ForeName': 'Sengly', 'Initials': 'S', 'LastName': 'Kong', 'Affiliation': 'Khmer Health Advocates, West Hartford, CT, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Fraser-King', 'Affiliation': 'Cambodian Diabetes Association, Siem Reap, Cambodia.'}, {'ForeName': 'Ien Srey', 'Initials': 'IS', 'LastName': 'Horn', 'Affiliation': 'Cambodian Diabetes Association, Siem Reap, Cambodia.'}, {'ForeName': 'Lim', 'Initials': 'L', 'LastName': 'Keuky', 'Affiliation': 'Cambodian Diabetes Association, Siem Reap, Cambodia.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09896-3']
2813,32436182,Lower serum bicarbonate is associated with an increased risk of acute kidney injury.,"BACKGROUND


Lower serum bicarbonate levels are associated with an increased risk of kidney disease progression. Whether lower serum bicarbonate levels are associated with an increased risk of developing acute kidney injury (AKI) is unclear.
METHODS


We included 8393 patients from the Systolic Blood Pressure Intervention Trial (SPRINT) that had baseline serum bicarbonate levels and complete data available. AKI was a predetermined adjudicated adverse event that was determined by hospital admission and discharge records with AKI as a recorded diagnosis. Serum bicarbonate was examined in clinically significant cutoffs ≤ 24, 25-28 and > 28 mEq/L, with 25-28 mEq/L as the reference group. Cox proportional hazard models were used to examine the association between serum bicarbonate and development of AKI.
RESULTS


The mean (SD) age, estimated glomerular filtration rate (eGFR), and serum bicarbonate level at baseline were 68 (9) years, 77 (23) ml/min/1.73m 2  and 26.3 (2.6) mEq/L, respectively. Participants with serum bicarbonate levels ≤ 24 mEq/L were more likely to be male and to have lower baseline eGFR. After a median follow-up time of 3.3 years, 293 participants developed AKI. More patients in the lower bicarbonate group developed AKI (6.1% vs 2.8% in the 25-28 mEq/L and 2.1% in the > 28 mEq/L). A bicarbonate level ≤ 24 mEq/L was associated with a significantly increased risk of AKI compared to those with a bicarbonate level of 25-28 mEq/L after full adjustment (HR 1.42, 95% CI 1.1-1.8).
CONCLUSION


Lower serum bicarbonate levels are an independent risk factor for the development of AKI.",2020,More patients in the lower bicarbonate group developed AKI (6.1% vs 2.8% in the 25-28 mEq/L and 2.1% in the > ,"['8393 patients from the Systolic Blood Pressure Intervention Trial (SPRINT) that had baseline serum bicarbonate levels and complete data available', 'Participants with serum bicarbonate levels']",['bicarbonate'],"['AKI', 'Serum bicarbonate', 'risk of AKI', 'Lower serum bicarbonate levels', 'mean (SD) age, estimated glomerular filtration rate (eGFR), and serum bicarbonate level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0005367', 'cui_str': 'Bicarbonate'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",8393.0,0.0971515,More patients in the lower bicarbonate group developed AKI (6.1% vs 2.8% in the 25-28 mEq/L and 2.1% in the > ,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kendrick', 'Affiliation': 'Univeristy of Colorado Anschutz Medical Campus, Aurora, CO, 80045, USA. Jessica.Kendrick@cuanschutz.edu.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Univeristy of Colorado Anschutz Medical Campus, Aurora, CO, 80045, USA.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'You', 'Affiliation': 'Univeristy of Colorado Anschutz Medical Campus, Aurora, CO, 80045, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jovanovich', 'Affiliation': 'Univeristy of Colorado Anschutz Medical Campus, Aurora, CO, 80045, USA.'}]",Journal of nephrology,['10.1007/s40620-020-00747-8']
2814,31816193,Ultra-Rapid Lispro results in accelerated insulin lispro absorption and faster early insulin action in comparison with Humalog ®  in Japanese patients with type 1 diabetes.,"AIMS/INTRODUCTION


Ultra-rapid lispro (URLi) is a novel ultra-rapid mealtime insulin. This study compared the pharmacokinetic and glucodynamic profiles, safety, and tolerability of URLi and lispro (Humalog ®  ) in Japanese patients with type 1 diabetes mellitus.
MATERIALS AND METHODS


This was a phase I, single center, randomized, patient- and investigator-blind, two-period, cross-over study. A total of 31 patients received a single subcutaneous 15-U dose of URLi or lispro before undergoing a euglycemic clamp procedure. Primary pharmacokinetic endpoints were the time to early half-maximal drug concentration and the area under the concentration versus time curve from 0 to 30 min postdose. The glucodynamic endpoints were the time to early half-maximal glucose infusion rate before time to maximum glucose infusion rate, and the time to onset of insulin action.
RESULTS


URLi showed accelerated insulin lispro absorption compared with lispro, as shown by a decrease of 56% (URLi: 10.2 min, lispro: 23.3 min; P < 0.0001) in the early half-maximal drug concentration, and a 2.4-fold increase in the area under the concentration versus time curve from 0 to 30 min (P < 0.0001). The duration of insulin lispro exposure was 88 min shorter after URLi administration compared with lispro. URLi reduced the early half-maximal glucose infusion rate before time to maximum glucose infusion rate and the time to onset of insulin action significantly compared with lispro. The glucose infused within the first 30 min of the clamp was 2.16-fold greater with URLi compared with lispro. There was no difference in total exposure or glucose infused between treatments. All treatment-emergent adverse events were mild/moderate in severity.
CONCLUSIONS


In Japanese type 1 diabetes mellitus patients, URLi showed accelerated insulin lispro absorption, reduced late exposure, overall shorter duration and faster early insulin action compared with lispro.",2020,URLi reduced the early half-maximal glucose infusion rate before time to maximum glucose infusion rate and the time to onset of insulin action significantly compared with lispro.,"['Japanese patients with type\xa01 diabetes', 'Japanese patients with type\xa01 diabetes mellitus', '31 patients']","['single subcutaneous 15-U dose of URLi or lispro before undergoing a euglycemic clamp procedure', 'Ultra-Rapid Lispro', 'Ultra-rapid lispro (URLi', 'URLi and lispro (Humalog ®  ']","['URLi reduced the early half-maximal glucose infusion rate before time to maximum glucose infusion rate and the time to onset of insulin action', 'accelerated insulin lispro absorption', 'time to early half-maximal glucose infusion rate before time to maximum glucose infusion rate, and the time to onset of insulin action', 'time to early half-maximal drug concentration and the area under the concentration versus time curve from 0 to 30\xa0min postdose', 'duration of insulin lispro exposure', 'pharmacokinetic and glucodynamic profiles, safety, and tolerability', 'accelerated insulin lispro absorption, reduced late exposure, overall shorter duration and faster early insulin action', 'total exposure or glucose']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C2362777', 'cui_str': 'Abnormally early (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0596104,URLi reduced the early half-maximal glucose infusion rate before time to maximum glucose infusion rate and the time to onset of insulin action significantly compared with lispro.,"[{'ForeName': 'Masanari', 'Initials': 'M', 'LastName': 'Shiramoto', 'Affiliation': 'SOUSEIKAI Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Nasu', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Oura', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Imori', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ohwaki', 'Affiliation': 'Eli Lilly Japan K.K., Kobe, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13195']
2815,31405797,Factors associated with antidepressant use among low-income racially and ethnically diverse patients with type 2 diabetes.,"OBJECTIVE


Depression is common in patients with type 2 diabetes and associated with poor diabetes-related outcomes. We evaluated the factors associated with antidepressant use in a low-income, racially and ethnically diverse sample of patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS


We performed a cross-sectional study of baseline data from participants in a cluster randomized trial evaluating a health literacy intervention for diabetes care in safety net clinics. Depressive symptoms were measured by the Center for Epidemiological Studies Depression Scale (CES-D); antidepressant use was abstracted from medication lists. Multivariable mixed effects logistic regression was used to evaluate the relationship between antidepressant use and race/ethnicity adjusting for depressive symptoms, age, gender, income, and health literacy.
RESULTS


Of 403 participants, 58% were non-Hispanic White, 18% were non-Hispanic Black, and 24% were Hispanic. Median age was 51 years old; 60% were female, 52% of participants had a positive screen for depression, and 18% were on antidepressants. Black and Hispanic participants were significantly less likely to be on an antidepressant compared with white participants, adjusted odds ratios 0.31(95% CI: 0.12 to 0.80) and 0.26 (95% CI: 0.10 to 0.74), respectively.
CONCLUSIONS


In this vulnerable population with type 2 diabetes, we found a high prevalence of depressive symptoms, and a small proportion of participants were on an antidepressant. Black and Hispanic participants were significantly less likely to be treated with an antidepressant. Our findings suggest depression may be inadequately treated in low-income, uninsured patients with type 2 diabetes, especially racial and ethnic minorities.",2019,"Black and Hispanic participants were significantly less likely to be on an antidepressant compared with white participants, adjusted odds ratios 0.31(95% CI: 0.12 to 0.80) and 0.26 (95% CI: 0.10 to 0.74), respectively.
","['Black and Hispanic participants', '403 participants', ' 58% were non-Hispanic White, 18% were non-Hispanic Black, and 24% were Hispanic', 'patients with type 2 diabetes and associated with poor diabetes-related outcomes', 'Median age was 51\u202fyears old; 60% were female, 52% of participants had a positive screen for depression, and 18% were on antidepressants', 'low-income racially and ethnically diverse patients with type 2 diabetes', 'patients with type 2 diabetes']",['health literacy intervention'],['Depressive symptoms'],"[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0302604', 'cui_str': 'Low income'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",403.0,0.0598766,"Black and Hispanic participants were significantly less likely to be on an antidepressant compared with white participants, adjusted odds ratios 0.31(95% CI: 0.12 to 0.80) and 0.26 (95% CI: 0.10 to 0.74), respectively.
","[{'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Presley', 'Affiliation': 'Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University Medical Center, 2525 West End Ave, Suite 450, Nashville, TN 37203, United States of America; Geriatric Research Education and Clinical Center, VA Tennessee Valley Healthcare System, 1310 24th Avenue South, Nashville, TN 37212, United States of America. Electronic address: capresley@uabmc.edu.'}, {'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'White', 'Affiliation': 'Division of Community Internal Medicine, Mayo Clinic, Cannaday Building, 3 West 4500 San Pablo Road, Jacksonville, FL 32224, United States of America. Electronic address: white.richard@mayo.edu.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Bian', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, 2525 West End, Suite 1100, Nashville, TN 37203, United States of America. Electronic address: aihua.bian@vanderbilt.edu.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Schildcrout', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, 2525 West End, Suite 1100, Nashville, TN 37203, United States of America; Department of Anesthesiology, Vanderbilt University Medical Center, 1211 Medical Center Dr, Nashville, TN 37232, United States of America. Electronic address: jonathan.schildcrout@vanderbilt.edu.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Rothman', 'Affiliation': 'Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University Medical Center, 2525 West End Ave, Suite 450, Nashville, TN 37203, United States of America. Electronic address: russell.rothman@vanderbilt.edu.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.07.002']
2816,32435908,Mechanical transnasal endoscopic dacryocystorhinostomy versus transcanalicular multidiode laser dacryocystorhinostomy: long-term results of a prospective study.,"The purpose of this study is to compare two dacryocystorhinostomy (DCR) techniques in epiphora treatment. This study is a prospective randomized trial. Twenty-nine patients presenting persistent epiphora due to primary acquired nasolacrimal duct obstruction (PANDO) were included in the study. Two groups each consisting of 15 eyes were formed. Mechanical transnasal endoscopic DCR (MTE-DCR) was applied to the first group, while transcanalicular dacryocystorhinostomy with multidiode laser (TCML-DCR) techniques is employed in the second group. Follow-up is conducted in the first day, first week, and first month of the dacryocystorhinostomy which is followed by 4-month follow-up period, and results were compared using statistical methods. The main outcome measures were the elimination of epiphora and unrestricted flow of irrigated saline to the nose. Seven patients were male, 22 were female, and the mean age was 39.3 ± 12.5 years. Mean follow-up times were 111.3 ± 10.5 months and 93 ± 2.9 months in group 1 and group 2, respectively. Complete resolution is achieved in group 1, whereas failures stemming from canalicular stenosis and fibrosis at osteotomy site are recorded in two cases in group 2. Occlusion occurred in the fifth month in both cases. Thus, long-term success rates were 100% in the first and 86.6% in the second group (P = 0.483). MTE-DCR is a strong substitute for external DCR. Although TCML-DCR shows promising results, it is far away from becoming the gold standard technique in epiphora treatment.",2020,"Thus, long-term success rates were 100% in the first and 86.6% in the second group (P = 0.483).","['epiphora treatment', 'Twenty-nine patients presenting persistent epiphora due to primary acquired nasolacrimal duct obstruction (PANDO) were included in the study', 'Seven patients were male, 22 were female, and the mean age was 39.3\u2009±\u200912.5\xa0years']","['Mechanical transnasal endoscopic dacryocystorhinostomy versus transcanalicular multidiode laser dacryocystorhinostomy', 'dacryocystorhinostomy with multidiode laser (TCML-DCR) techniques', 'TCML-DCR', 'Mechanical transnasal endoscopic DCR (MTE-DCR']","['long-term success rates', 'elimination of epiphora and unrestricted flow of irrigated saline to the nose', 'Occlusion', 'Complete resolution']","[{'cui': 'C0152227', 'cui_str': 'Epiphora'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1282418', 'cui_str': 'Primary acquired nasolacrimal duct obstruction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0395256', 'cui_str': 'Intranasal dacryocystorhinostomy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0152227', 'cui_str': 'Epiphora'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",29.0,0.0141454,"Thus, long-term success rates were 100% in the first and 86.6% in the second group (P = 0.483).","[{'ForeName': 'Hanife Tuba', 'Initials': 'HT', 'LastName': 'Akcam', 'Affiliation': 'Ophthalmology Department, Duzce University School of Medicine, 81620, Duzce, Turkey. hanifetuba@hotmail.com.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Konuk', 'Affiliation': 'Ophthalmology Department, Gazi University School of Medicine, Ankara, Turkey.'}]",Lasers in medical science,['10.1007/s10103-020-03038-7']
2817,32435929,Effectiveness of the clinical decision support tool ESR eGUIDE for teaching medical students the appropriate selection of imaging tests: randomized cross-over evaluation.,"OBJECTIVES


To evaluate ESR eGUIDE-the European Society of Radiology (ESR) e-Learning tool for appropriate use of diagnostic imaging modalities-for learning purposes in different clinical scenarios.
METHODS


This anonymized evaluation was performed after approval of ESR Education on Demand leadership. Forty clinical scenarios were developed in which at least one imaging modality was clinically most appropriate, and the scenarios were divided into sets 1 and 2. These sets were provided to medical students randomly assigned to group A or B to select the most appropriate imaging test for each scenario. Statistical comparisons were made within and across groups.
RESULTS


Overall, 40 medical students participated, and 31 medical students (78%) answered both sets. The number of correctly chosen imaging methods per set in these 31 paired samples was significantly higher when answered with versus without use of ESR eGUIDE (13.7 ± 2.6 questions vs. 12.1 ± 3.2, p = 0.012). Among the students in group A, who first answered set 1 without ESR eGUIDE (11.1 ± 3.2), there was significant improvement when set 2 was answered with ESR eGUIDE (14.3 ± 2.5, p = 0.013). The number of correct answers in group B did not drop when set 2 was answered without ESR eGUIDE (12.4 ± 2.6) after having answered set 1 first with ESR eGUIDE (13.0 ± 2.7, p = 0.66).
CONCLUSION


The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
KEY POINTS


• ESR eGUIDE improved the number of appropriately selected imaging modalities among medical students. • This improvement was also seen in the group of students which first selected imaging tests without ESR eGUIDE. • In the student group which used ESR eGUIDE first, appropriate selection remained stable even without the teaching tool.",2020,"The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
","['40 medical students participated, and 31 medical students (78%) answered both sets', 'teaching medical students']",[],['number of correct answers'],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039401', 'cui_str': 'Education'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",,0.0195978,"The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
","[{'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Diekhoff', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Kainberger', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Oleaga', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany. marc.dewey@charite.de.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}]",European radiology,['10.1007/s00330-020-06942-2']
2818,32011717,Impact of minimally invasive extracorporeal circulation on coagulation-a randomized trial.,"OBJECTIVES


Minimally invasive extracorporeal circulation (MiECC) is suggested to have favourable impact on blood loss compared to conventional extracorporeal circulation. We aimed to compare the impact of both systems on coagulation.
METHODS


Randomized trial comparing endogenous thrombin-generating potential early after elective coronary surgery employing either MiECC group (n = 30) or conventional extracorporeal circulation group (n = 30). Secondary outcomes were in vivo thrombin generation, bleeding end points and haemodilution, as well as morbidity and mortality up to 30-day follow-up.
RESULTS


Compared to the conventional extracorporeal circulation group, the MiECC group showed (i) a trend towards a higher early postoperative endogenous thrombin-generating potential (P = 0.06), (ii) lower intraoperative levels of thrombin-antithrombin complex and prothrombin fragment 1 + 2 (P < 0.001), (iii) less haemodilution early postoperatively as measured by haematocrit and weight gain, but without correlation to coagulation factors or bleeding end points. Moreover, half as many patients required postoperative blood transfusion in the MiECC group (17% vs 37%, P = 0.14), although postoperative blood loss did not differ between groups (P = 0.84). Thrombin-antithrombin complex levels (rs = 0.36, P = 0.005) and prothrombin fragment 1 + 2 (rs = 0.45, P < 0.001), but not early postoperative endogenous thrombin-generating potential (rs = 0.05, P = 0.72), showed significant correlation to increased transfusion requirements. The MiECC group demonstrated significantly lower levels of creatine kinase-MB, lactate dehydrogenase and free haemoglobin indicating superior myocardial protection, less tissue damage and less haemolysis, respectively. Perioperative morbidity and 30-day mortality did not differ between groups.
CONCLUSIONS


Conventional but not MiECC is associated with significant intraoperative thrombin generation despite full heparinization. No correlation between coagulation factors or bleeding end points with the degree of haemodilution could be ascertained.
CLINICALTRIALS.GOV IDENTIFIER


NCT03216720.",2020,"The MiECC group demonstrated significantly lower levels of creatine kinase-MB, lactate dehydrogenase and free haemoglobin indicating superior myocardial protection, less tissue damage and less haemolysis, respectively.",[],"['endogenous thrombin-generating potential early after elective coronary surgery employing either MiECC', 'MiECC', 'Minimally invasive extracorporeal circulation (MiECC', 'minimally invasive extracorporeal circulation', 'conventional extracorporeal circulation']","['postoperative blood loss', 'Thrombin-antithrombin complex levels', 'Perioperative morbidity and 30-day mortality', 'vivo thrombin generation, bleeding end points and haemodilution, as well as morbidity and mortality up to 30-day follow-up', 'haematocrit and weight gain', 'intraoperative levels of thrombin-antithrombin complex and prothrombin fragment 1\u2009+\u20092', 'transfusion requirements', 'postoperative blood transfusion', 'blood loss', 'levels of creatine kinase-MB, lactate dehydrogenase and free haemoglobin indicating superior myocardial protection, less tissue damage and less haemolysis']",[],"[{'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal Circulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0019009', 'cui_str': 'Hemodilution'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0072435', 'cui_str': 'prothrombin profragment-1'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0523584', 'cui_str': 'Creatine kinase MB measurement'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C3854324', 'cui_str': 'Free hemoglobin'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C2937287', 'cui_str': 'Hemolysis (observable entity)'}]",,0.0676663,"The MiECC group demonstrated significantly lower levels of creatine kinase-MB, lactate dehydrogenase and free haemoglobin indicating superior myocardial protection, less tissue damage and less haemolysis, respectively.","[{'ForeName': 'Ivy Susanne', 'Initials': 'IS', 'LastName': 'Modrau', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Debbie Richards', 'Initials': 'DR', 'LastName': 'Halle', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Per Hostrup', 'Initials': 'PH', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Hans Henrik', 'Initials': 'HH', 'LastName': 'Kimose', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jacob Raben', 'Initials': 'JR', 'LastName': 'Greisen', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kremke', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anne-Mette', 'Initials': 'AM', 'LastName': 'Hvas', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezaa010']
2819,32435609,"Ketogenic, Hypocaloric Diet Improves Nonalcoholic Steatohepatitis.","Background and objectives


Nonalcoholic steatohepatitis (NASH) is strongly associated with obesity. A weight loss of ≥10% is necessary to improve NASH severity, but this goal has rarely been achieved in published studies using different diet protocols. The effect of a ketogenic, hypocaloric, commercial diet (""Ideal Protein,"" IP) on body weight, metabolic markers, and liver tests in a group of NASH patients is evaluated in this study. Daily calorie intake was tailored to achieve a weight loss of ≥10%.
Methods


We analyzed 38 patients with NASH who were placed on the IP diet between 2014 and 2018 and compared their outcomes with 6 control patients who declined the diet. All patients were evaluated by a trained health coach in weekly intervals throughout the study period. Clinical and laboratory data obtained before and at 6.5 months after intervention were compared using paired t-testing.
Results


The patients on the IP diet experienced a significant weight reduction (217 ± 8 lb  vs . 194 ± 7 lb; mean ± S.E.M.), corresponding to an average weight loss of 9.7% ± 1.6%. Significant changes in systolic blood pressure (133 ± 3 mmHg  vs . 123 ± 3 mmHg), triglycerides (200 ± 21 mmol/L  vs . 132 ± 11 mmol/L), hemoglobin A1c (6.71% ± 0.29%  vs . 5.74% ± 0.19%), SGPT (97.3 ± 11.1 IU/L  vs . 44.2 ± 5.9 IU/L), SGOT (82.4 ± 10.5 IU/L  vs . 32.8 ± 5.2 IU/L), and Fib-4 scores (2.25 ± 0.23  vs . 1.40 ± 0.13) were also observed ( P <0.05 in all cases). In the IP group, 50.5% of patients lost ≥10% body weight. In contrast, no significant changes were observed in the control group. The IP diet was well tolerated, and no safety signals were noticed.
Conclusions


A ketogenic, hypocaloric resulted in striking weight loss and significant improvements in metabolic parameters and liver tests, suggesting that this approach carries promise for the dietary management of patients with NASH.",2020,Significant changes in systolic blood pressure (133 ± 3 mmHg  vs .,"['38 patients with NASH who were placed on the IP diet between 2014 and 2018 and compared their outcomes with 6 control patients who declined the diet', 'patients with NASH']","['Ketogenic, Hypocaloric Diet', 'Nonalcoholic steatohepatitis (NASH', 'ketogenic, hypocaloric, commercial diet (""Ideal Protein,"" IP', 'SGPT']","['body weight, metabolic markers, and liver tests', 'hemoglobin A1c', 'striking weight loss', 'tolerated, and no safety signals', 'systolic blood pressure', 'metabolic parameters and liver tests', 'weight reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0036828', 'cui_str': 'SGPT'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",38.0,0.0277578,Significant changes in systolic blood pressure (133 ± 3 mmHg  vs .,"[{'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Belopolsky', 'Affiliation': 'Division of Internal Medicine, NorthShore University HealthSystem, Evanston, Illinois, USA.'}, {'ForeName': 'Mohammad Q', 'Initials': 'MQ', 'LastName': 'Khan', 'Affiliation': 'Division of Gastroenterology, NorthShore University HealthSystem, Evanston, Illinois, USA.'}, {'ForeName': 'Amnon', 'Initials': 'A', 'LastName': 'Sonnenberg', 'Affiliation': 'Portland VA Medical Center and Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Davidson', 'Affiliation': 'Division of Cardiology, NorthShore University HealthSystem, Evanston, Illinois, USA.'}, {'ForeName': 'Claus J', 'Initials': 'CJ', 'LastName': 'Fimmel', 'Affiliation': 'Division of Gastroenterology, NorthShore University HealthSystem, Evanston, Illinois, USA.'}]",Journal of translational internal medicine,['10.2478/jtim-2020-0005']
2820,32435960,Hernia incidence following a randomized clinical trial of single-incision versus multi-port laparoscopic colectomy.,"BACKGROUND


The short-term results of single-incision laparoscopic colectomy (SILC) showed the safety, feasibility, and effectiveness when performed by skilled laparoscopic surgeons. However, the long-term complications, such as SILC-associated incisional hernia, have not been evaluated. The aim of this study was to determine the incidence of incisional hernia after SILC compared with multi-port laparoscopic colectomy (MPC) for colon cancer.
METHODS


From March 2012, to March 2015, a total of 200 patients were enrolled in this study. The patients were randomized to the MPC arm and SILC arm. A total of 200 patients (MPC arm; 100 patients, SILC arm; 100 patients) were therefore analyzed. In all cases the specimen was extracted through the umbilical port, which was extended according to the size of the specimen. A diagnosis of incisional hernia was made either based on a physical examination or computed tomography.
RESULTS


The baseline factors were well balanced between the arms. The median follow-up period was 42.4 (range 9.4-70.0) months. Twenty-one patients were diagnosed with incisional hernia, giving an incidence rate of 12.1% in the MPC arm and 9.0% in the SILC arm at 36 months (P = 0.451). In the multivariate analysis, the body mass index (≥ 25 kg/m 2 ) (hazard ratio [HR] 3.03; 95% confidence interval [CI] 1.03-8.92; P = 0.044), umbilical incision (≥ 5.0 cm) (HR 3.22; 95% CI 1.16-8.93; P = 0.025), and history of umbilical hernia (HR 3.16; 95% CI 1.02-9.77; P = 0.045) were shown to be correlated with incisional hernia.
CONCLUSIONS


We found no significant difference in the incidence of incisional hernia after SILC arm versus MPC arm with a long-term follow-up. However, this result may be biased because all specimens were harvested through the umbilical port. The study was registered with the Japanese Clinical Trials Registry as UMIN000007220.",2020,We found no significant difference in the incidence of incisional hernia after SILC arm versus MPC arm with a long-term follow-up.,"['From March 2012, to March 2015, a total of 200 patients were enrolled in this study', '200 patients (MPC arm; 100 patients, SILC arm; 100 patients']","['single-incision versus multi-port laparoscopic colectomy', 'single-incision laparoscopic colectomy (SILC', 'multi-port laparoscopic colectomy (MPC']","['incidence rate', 'history of umbilical hernia', 'body mass index', 'Hernia incidence', 'umbilical incision', 'incisional hernia', 'incidence of incisional hernia', 'safety, feasibility, and effectiveness']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0019322', 'cui_str': 'Umbilical hernia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0198493', 'cui_str': 'Incision of umbilicus'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",21.0,0.244549,We found no significant difference in the incidence of incisional hernia after SILC arm versus MPC arm with a long-term follow-up.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan. nabe-jun@comet.ocn.ne.jp.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ishibe', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Suwa', 'Affiliation': 'Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Suwa', 'Affiliation': 'Department of Surgery, Yokosuka Kyosai Hospital, Yokosuka, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Ota', 'Affiliation': 'Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Chikara', 'Initials': 'C', 'LastName': 'Kunisaki', 'Affiliation': 'Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Endo', 'Affiliation': 'Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}]",Surgical endoscopy,['10.1007/s00464-020-07656-8']
2821,32435967,"Protein intake, weight loss, dietary intervention, and worsening of quality of life in older patients during chemotherapy for cancer.","Decreased health-related quality of life (HRQoL) is common in patients with cancer. We investigated the effects of dietary intervention and baseline nutritional status on worsening of HRQoL in older patients during chemotherapy. In this randomized control trial assessing the effect on mortality of dietary advice to increase dietary intake during chemotherapy, this post hoc analysis included 155 patients with cancer at risk of malnutrition. The effects of dietary intervention, baseline Mini Nutritional Assessment item scores, weight loss, and protein and energy intake before treatment on the worsening of HRQoL (physical functioning, fatigue) and secondary outcomes (Timed Up and Go test, one-leg stance time, depressive symptoms, basic (ADL), or instrumental (IADL) activities of daily living) were analyzed by multinomial regressions. Dietary intervention increased total energy and protein intake but had no effect on any examined outcomes. Worsening of fatigue and ADL was predicted by very low protein intake (< 0.8 g kg -1  day -1 ) before chemotherapy (OR 3.02, 95% CI 1.22-7.46, p = 0.018 and OR 5.21, 95% CI 1.18-22.73, p = 0.029 respectively). Increase in depressive symptomatology was predicted by 5.0-9.9% weight loss before chemotherapy (OR 2.68, 95% CI 1.10-6.80, p = 0.038). Nutritional intervention to prevent HRQoL decline during chemotherapy should focus on patients with very low protein intake along with those with weight loss.",2020,"Worsening of fatigue and ADL was predicted by very low protein intake (< 0.8 g kg -1  day -1 ) before chemotherapy (OR 3.02, 95% CI 1.22-7.46, p = 0.018 and OR 5.21, 95% CI 1.18-22.73, p = 0.029 respectively).","['155 patients with cancer at risk of malnutrition', 'older patients during chemotherapy for cancer', 'older patients during chemotherapy', 'patients with cancer']","['Nutritional intervention', 'dietary intervention and baseline nutritional status']","['depressive symptomatology', 'HRQoL decline', 'Protein intake, weight loss, dietary intervention, and worsening of quality of life', 'baseline Mini Nutritional Assessment item scores, weight loss, and protein and energy intake', 'total energy and protein intake', 'worsening of HRQoL (physical functioning, fatigue) and secondary outcomes ', 'Worsening of fatigue and ADL', 'Decreased health-related quality of life (HRQoL', 'Timed Up and Go test, one-leg stance time, depressive symptoms, basic (ADL), or instrumental (IADL) activities of daily living']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}]",155.0,0.0379224,"Worsening of fatigue and ADL was predicted by very low protein intake (< 0.8 g kg -1  day -1 ) before chemotherapy (OR 3.02, 95% CI 1.22-7.46, p = 0.018 and OR 5.21, 95% CI 1.18-22.73, p = 0.029 respectively).","[{'ForeName': 'Sophie C', 'Initials': 'SC', 'LastName': 'Regueme', 'Affiliation': 'Clinical Gerontology Department, CHU Bordeaux, 33000, Bordeaux, France.'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Echeverria', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, (Bizkaia), Spain.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Monéger', 'Affiliation': 'Clinical Gerontology Department, CHU Bordeaux, 33000, Bordeaux, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Durrieu', 'Affiliation': 'Clinical Gerontology Department, CHU Bordeaux, 33000, Bordeaux, France.'}, {'ForeName': 'Maïté', 'Initials': 'M', 'LastName': 'Becerro-Hallard', 'Affiliation': 'Geriatrics department, Centre Hospitalier Layné-Mont de Marsan, 40000, Mont-de-Marsan, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Duc', 'Affiliation': 'Clinical Gerontology Department, CHU Bordeaux, 33000, Bordeaux, France.'}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Lafargue', 'Affiliation': 'Clinical Gerontology Department, CHU Bordeaux, 33000, Bordeaux, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Mertens', 'Affiliation': 'Clinical Gerontology Department, CHU Bordeaux, 33000, Bordeaux, France.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Laksir', 'Affiliation': 'Clinical Gerontology Department, CHU Bordeaux, 33000, Bordeaux, France.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Ceccaldi', 'Affiliation': 'Centre Hospitalier de Libourne, 33500, Libourne, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lavau-Denes', 'Affiliation': 'CHU Limoges, Université de Limoges, Limoges, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Dantoine', 'Affiliation': 'CHU Limoges, Université de Limoges, Limoges, France.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Irazusta', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa, (Bizkaia), Spain.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Bourdel-Marchasson', 'Affiliation': 'Clinical Gerontology Department, CHU Bordeaux, 33000, Bordeaux, France. isabelle.bourdel-marchasson@chu-bordeaux.fr.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05528-4']
2822,32435968,Jaw exercise therapy for the treatment of trismus in head and neck Cancer: a prospective three-year follow-up study.,"PURPOSE


This study aims to examine effects of jaw exercise on trismus 3 years following completion of a post-radiotherapy jaw exercise intervention.
METHODS


Prospective study including 50 patients with head-and-neck cancer receiving radiotherapy and/or chemotherapy, plus a matched control group. The intervention group underwent 10 weeks of jaw exercise training. Patients were followed pre-and postintervention and 3 years postintervention completion. Outcome measures were maximal interincisal opening (MIO), trismus-related symptoms, and health-related quality-of-life as measured by Gothenburg Trismus Questionnaire, EORTC QLQ-C30, and EORTC QLQ-H&N35.
RESULTS


The intervention group had a statistically significantly higher mean MIO compared with the control group (40.1 mm and 33.9 mm, respectively, p < 0.001), reported less trismus-related problems and had an improved health-related quality-of-life when compared with the control group at the 3-year follow-up. These differences were all statistically significant.
CONCLUSION


Jaw exercise therapy resulted in increased MIO, less trismus-related symptoms, and improved health-related quality-of-life. Jaw exercise therapy should be initiated early, in a structured manner and continued long-term.",2020,"The intervention group had a statistically significantly higher mean MIO compared with the control group (40.1 mm and 33.9 mm, respectively, p < 0.001), reported less trismus-related problems and had an improved health-related quality-of-life when compared with the control group at the 3-year follow-up.","['trismus in head and neck Cancer', '50 patients with head-and-neck cancer receiving']","['jaw exercise training', 'jaw exercise', 'radiotherapy jaw exercise intervention', 'radiotherapy and/or chemotherapy, plus a matched control group', 'Jaw exercise therapy']","['health-related quality-of-life', 'mean MIO', 'MIO, less trismus-related symptoms, and improved health-related quality-of-life', 'maximal interincisal opening (MIO), trismus-related symptoms, and health-related quality-of-life as measured by Gothenburg Trismus Questionnaire, EORTC QLQ-C30, and EORTC QLQ-H&N35']","[{'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",50.0,0.0465911,"The intervention group had a statistically significantly higher mean MIO compared with the control group (40.1 mm and 33.9 mm, respectively, p < 0.001), reported less trismus-related problems and had an improved health-related quality-of-life when compared with the control group at the 3-year follow-up.","[{'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Karlsson', 'Affiliation': 'Department of Anaesthesiology, Institute of Clinical Science, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Karlsson', 'Affiliation': 'Department of Otorhinolaryngology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden. therese.karlsson.2@gu.se.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Pauli', 'Affiliation': 'Department of Otorhinolaryngology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Paulin', 'Initials': 'P', 'LastName': 'Andréll', 'Affiliation': 'Department of Otorhinolaryngology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Finizia', 'Affiliation': 'Department of Otorhinolaryngology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05517-7']
2823,32435693,Case-Based Learning as an Effective Tool in Teaching Pharmacology to Undergraduate Medical Students in a Large Group Setting.,"Background


The need for case-based learning in basic subjects is being recognized world over. Early clinical illustrations and actual clinical exposure enable students to associate basic science and real patient situations, probably increasing their retention of knowledge. The study was conducted to introduce an alternate method of teaching-learning in pharmacology in a large classroom setting to integrate pharmacology into clinical setting for better learning and understanding of the subject.
Methods


Ninety-four students of second professional MBBS of a medical college in Punjab were divided into 2 groups and were taught a 2-hour topic in pharmacology using case-based learning (CBL) method and didactic lecture (DL) method using a crossover design. Their attendance and written test score at the end of teaching session were compared. Feedback from students and faculty was taken by prestructured questionnaires.
Results


There was an increase in students' attendance ( P  = .008) in CBL sessions but insignificant difference in their performance ( P  = .98) in the tests. Most (84%) of the students felt that CBL is a better method of teaching-learning than traditional DL. The teaching faculty felt that the students looked more interested and were themselves more motivated for the newer method of teaching.
Conclusions


Case-based learning led to improvement in student motivation, satisfaction, and engagement. Most students and faculty accepted that CBL was an effective learning tool for pharmacology teaching in a large group setting and supported the incorporation of CBL into traditional DL teaching.",2020,There was an increase in students' attendance ( P  = .008) in CBL sessions but insignificant difference in their performance ( P  = .98) in the tests.,"['Methods\n\n\nNinety-four students of second professional MBBS of a medical college in Punjab', 'Undergraduate Medical Students in a Large Group Setting']","['2-hour topic in pharmacology using case-based learning (CBL) method and didactic lecture (DL', 'CBL']","[""students' attendance"", 'student motivation, satisfaction, and engagement']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",94.0,0.0155617,There was an increase in students' attendance ( P  = .008) in CBL sessions but insignificant difference in their performance ( P  = .98) in the tests.,"[{'ForeName': 'Gurleen', 'Initials': 'G', 'LastName': 'Kaur', 'Affiliation': 'Department of Pharmacology, Adesh Medical College & Hospital, Kurukshetra, India.'}, {'ForeName': 'Jagdeep', 'Initials': 'J', 'LastName': 'Rehncy', 'Affiliation': 'Department of Orthopaedics, Government Medical College, Patiala, India.'}, {'ForeName': 'Karamdeep Singh', 'Initials': 'KS', 'LastName': 'Kahal', 'Affiliation': 'Department of Orthopaedics, Government Medical College, Patiala, India.'}, {'ForeName': 'Jaspreet', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Department of Orthopaedics, Government Medical College, Patiala, India.'}, {'ForeName': 'Vidushi', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Department of Pharmacology, Maharishi Markandeshwar (Deemed to be University) (MMDU), Mullana, India.'}, {'ForeName': 'Prithpal Singh', 'Initials': 'PS', 'LastName': 'Matreja', 'Affiliation': 'Department of Pharmacology, Teerthanker Mahaveer Medical College & Research Centre (TMMC&RC), Teerthanker Mahaveer University (TMU), Moradabad, India.'}, {'ForeName': 'Harmandeep', 'Initials': 'H', 'LastName': 'Grewal', 'Affiliation': 'Department of Microbiology, Government Medical College, Patiala, India.'}]",Journal of medical education and curricular development,['10.1177/2382120520920640']
2824,32433165,Effect of Different 131I Dose Strategies for Treatment of Hyperthyroidism on Graves' Ophthalmopathy.,"PURPOSE


The study aims to define the effect of different dose strategies on ophthalmic complications in patients with Graves' disease (GD).
METHODS


All the patients with GD and no or inactive ophthalmopathy (clinical activity score; CAS < 3) underwent Snellen chart examination, measurement of proptosis, thyroid volume, and radioactive iodine uptake, and randomized into 1 of 3 groups. In group 1, all the patients received fixed low dose (FLD) of 259 MBq of I, whereas in group 2, all the patients received fixed high dose (FHD) of 555 MBq, and in group 3, calculated dose (CD) was administered to deliver 5.55 MBq/g (thyroid weight) of I. All examinations were repeated 6 months after treatment. The measurement of thyroid function tests and clinical examination were repeated after 12 months.
RESULTS


We studied 92 patients (58 female and 34 male) with mean age of 38.2 ± 12.0 years. Overall, 29, 32, and 31 patients were studied in FLD, FHD, and CD groups, respectively. The patients in CD received a mean activity of 240.5 MBq. The 3 groups were not significantly different regarding age, sex ratio, radioactive iodine uptake, smoking, visual acuity, and proptosis. The response rate 12 months after radioactive iodine therapy was 66.7%, 94.4%, and 92.9% in FLD, FHD, and CD groups, respectively (P = 0.05). Overall, CAS was increased significantly after treatment. Delta proptosis and delta CAS were increased significantly in FHD group compared with other groups (P < 0.05). The highest increment in proptosis was seen in FHD group.
CONCLUSIONS


The administration of 5.55 MBq/g of I has fewer ophthalmic complications compared with high fixed dose model and is more effective than low fixed dose strategy.",2020,Delta proptosis and delta CAS were increased significantly in FHD group compared with other groups (P < 0.05).,"['92 patients (58 female and 34 male) with mean age of 38.2 ± 12.0 years', ""patients with Graves' disease (GD""]",['radioactive iodine therapy'],"['Delta proptosis and delta CAS', 'response rate', 'ophthalmic complications', 'age, sex ratio, radioactive iodine uptake, smoking, visual acuity, and proptosis', 'CAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0203610', 'cui_str': 'Teleradiotherapy with iodine-125'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0015300', 'cui_str': 'Exophthalmos'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036893', 'cui_str': 'Sex Ratio'}, {'cui': 'C0203778', 'cui_str': 'Radionuclide imaging of thyroid using iodine radioisotope'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",92.0,0.0359855,Delta proptosis and delta CAS were increased significantly in FHD group compared with other groups (P < 0.05).,"[{'ForeName': 'Shahrara', 'Initials': 'S', 'LastName': 'Ariamanesh', 'Affiliation': 'From the Nuclear Medicine Research Center.'}, {'ForeName': 'Narjess', 'Initials': 'N', 'LastName': 'Ayati', 'Affiliation': 'From the Nuclear Medicine Research Center.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mazloum Khorasani', 'Affiliation': 'Metabolic Syndrome Research Center.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Mousavi', 'Affiliation': 'Metabolic Syndrome Research Center.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Kiavash', 'Affiliation': 'Ophthalmology Department, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Kiamanesh', 'Affiliation': 'From the Nuclear Medicine Research Center.'}, {'ForeName': 'Seyed Rasoul', 'Initials': 'SR', 'LastName': 'Zakavi', 'Affiliation': 'From the Nuclear Medicine Research Center.'}]",Clinical nuclear medicine,['10.1097/RLU.0000000000003086']
2825,32436048,Is intracytoplasmic sperm (ICSI) better than traditional in vitro fertilization (IVF): confirmation of higher blastocyst rates per oocyte using a split insemination design.,"PURPOSE


To explore the effects of traditional vs. intracytoplasmic sperm injection (ICSI) insemination method on the outcome of high-quality blastocyst development in a split sibling oocyte cohort.
METHODS


In this retrospective cohort study, we analyzed 62 ICSI/IVF split cycles. Sibling oocytes were randomly assigned to ICSI or IVF insemination. Two hundred thirty-four ICSI-only cycles and 152 IVF-only cycles were also analyzed for comparison. Blastocysts were graded by Gardner's embryo grading and were considered a high-quality blastocyst if 3BB or better (Gardner 1999).
RESULTS


In the ICSI/IVF split group, (1) ICSI oocytes had a higher fertilization rate per oocyte allocated (73% vs 62%, p < 0.001), (2) more high-quality day 2 embryos (69% vs 55%, p < 0.005), (3) ICSI oocytes had a lower blastulation rate per 2PN (46% vs 54%, p < 0.05), but a higher blastulation rate when calculated per oocyte allocated (40% vs 32%, p < 0.05). The ICSI-only group had a lower fertilization rate (65% vs 70%, p < 0.001) but more high-quality day 2 embryos in comparison to the IVF-only group (68% vs 64%, p < .05). The total high-quality blastulation rate was higher for the IVF-only group per 2PN (49% vs 43%, p < 0.05) and per oocyte retrieved (34% vs 28%, p < 0.05).
CONCLUSIONS


This distinctive IVF/ICSI sibling oocyte split design demonstrated a higher-quality blastulation rate in the IVF group compared to the ICSI group when calculated per 2PN, but not per oocyte allocated to each insemination procedure.",2020,"The ICSI-only group had a lower fertilization rate (65% vs 70%, p < 0.001) but more high-quality day 2 embryos in comparison to the IVF-only group (68% vs 64%, p < .05).","['Sibling oocytes', 'a split sibling oocyte cohort']","['ICSI', 'ICSI or IVF insemination', '2PN', 'traditional vs. intracytoplasmic sperm injection (ICSI) insemination method']","['fertilization rate', 'high-quality day 2 embryos', 'blastulation rate', 'quality blastulation rate', 'blastulation rate per 2PN', 'total high-quality blastulation rate']","[{'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.207194,"The ICSI-only group had a lower fertilization rate (65% vs 70%, p < 0.001) but more high-quality day 2 embryos in comparison to the IVF-only group (68% vs 64%, p < .05).","[{'ForeName': 'May-Tal', 'Initials': 'MT', 'LastName': 'Sauerbrun-Cutler', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women & Infants Hospital, 90 plain street, Providence, RI, 02905, USA. msauerbruncutle@wihri.org.'}, {'ForeName': 'Warren J', 'Initials': 'WJ', 'LastName': 'Huber', 'Affiliation': 'The Fertility Institute of New Orleans, 4770 S I-10 Service Rd W Ste 201, Metairie, LA, 94087, USA.'}, {'ForeName': 'Phinnara', 'Initials': 'P', 'LastName': 'Has', 'Affiliation': 'Division of Research, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women & Infants Hospital, 90 Plain Street, Providence, RI, 02905, USA.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women & Infants Hospital, 90 plain street, Providence, RI, 02905, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hackett', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women & Infants Hospital, 90 plain street, Providence, RI, 02905, USA.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Alvero', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Stanford Medical School, 1195 W Fremont Ave, Sunnyvale, CA, 94087, USA.'}, {'ForeName': 'Shunping', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women & Infants Hospital, 90 plain street, Providence, RI, 02905, USA.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-020-01819-1']
2826,32436085,A Trinity regimen with aflibercept for treatment-naïve neovascular age-related macular degeneration: 2-year outcomes.,"PURPOSE


To evaluate the advantages of the Trinity regimen for treatment-naïve neovascular age-related macular degeneration (nAMD).
METHODS


Thirty-one treatment-naïve nAMD eyes were treated using the Trinity regimen with an intravitreal aflibercept injection (IVA) and evaluated after 24 months. Three treatment methods, pro re nata (PRN), treat and extend (TAE), and fixed regimen were changed depending on recurrence frequency. After the initial treatment, PRN or TAE (started for 4 or 8 weeks) was selected as per the recurrence interval. Subsequently, the recurrence interval became constant, transitioning from a TAE to fixed regimen. When the recurrence frequency became irregular, the treatment regimen was changed to TAE.
RESULTS


After the initial treatment, 15 eyes (48.4%) were allocated to the PRN group, 12 (38.7%) to the TAE 8-week group, and 4 (12.9%) to the TAE 4-week group. Mean logMAR significantly improved in all cases, 0.53 ± 0.40 at baseline to 0.36 ± 0.34 at 24 months (p < 0.01), in the PRN group (0.63 ± 0.46 to 0.42 ± 0.43, p < 0.01), and the TAE 8-week group (0.44 ± 0.29 to 0.27 ± 0.19, p < 0.05). LogMAR in the TAE 4-week group was maintained. The mean number of injections for all and in the PRN, TAE 8-week, and TAE 4-week groups were 9.7, 5.3, 13.1, and 15.8, respectively, with the PRN group being significantly less (p < 0.01).
CONCLUSION


The Trinity regimen delivered the benefits of the PRN, TAE, and FIXED regimens while minimizing injections during the early treatment phase without visual loss.
TRIAL REGISTRATION


This trial was registered with the University Hospital Medical Information Network (UMIN ID: 000038335).",2020,"Mean logMAR significantly improved in all cases, 0.53 ± 0.40 at baseline to 0.36 ± 0.34 at 24 months (p < 0.01), in the PRN group (0.63 ± 0.46 to 0.42 ± 0.43, p < 0.01), and the TAE 8-week group (0.44 ± 0.29 to 0.27 ± 0.19, p < 0.05).","['treatment-naïve neovascular age-related macular degeneration', 'treatment-naïve neovascular age-related macular degeneration (nAMD', 'Thirty-one', 'treatment-naïve nAMD eyes']","['intravitreal aflibercept injection (IVA', 'aflibercept', 'PRN or TAE']","['Mean logMAR', 'mean number of injections']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",,0.0281063,"Mean logMAR significantly improved in all cases, 0.53 ± 0.40 at baseline to 0.36 ± 0.34 at 24 months (p < 0.01), in the PRN group (0.63 ± 0.46 to 0.42 ± 0.43, p < 0.01), and the TAE 8-week group (0.44 ± 0.29 to 0.27 ± 0.19, p < 0.05).","[{'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Wakuta', 'Affiliation': 'Department of Ophthalmology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube City, Yamaguchi, 755-0046, Japan.'}, {'ForeName': 'Nanami', 'Initials': 'N', 'LastName': 'Nomi', 'Affiliation': 'JCHO Shimonoseki Medical Center, Shimonoseki, Japan.'}, {'ForeName': 'Tadahiko', 'Initials': 'T', 'LastName': 'Ogata', 'Affiliation': 'Department of Ophthalmology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube City, Yamaguchi, 755-0046, Japan.'}, {'ForeName': 'Manami', 'Initials': 'M', 'LastName': 'Ota', 'Affiliation': 'Department of Ophthalmology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube City, Yamaguchi, 755-0046, Japan.'}, {'ForeName': 'Chiemi', 'Initials': 'C', 'LastName': 'Yamashiro', 'Affiliation': 'Department of Ophthalmology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube City, Yamaguchi, 755-0046, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Hatano', 'Affiliation': 'Department of Ophthalmology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube City, Yamaguchi, 755-0046, Japan.'}, {'ForeName': 'Ryoji', 'Initials': 'R', 'LastName': 'Yanai', 'Affiliation': 'Department of Ophthalmology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube City, Yamaguchi, 755-0046, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Tokuda', 'Affiliation': 'Department of Ophthalmology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube City, Yamaguchi, 755-0046, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Ophthalmology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube City, Yamaguchi, 755-0046, Japan. k.kimura@yamaguchi-u.ac.jp.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04745-1']
2827,32433273,β-Galactooligosaccharide in Conjunction With Low FODMAP Diet Improves Irritable Bowel Syndrome Symptoms but Reduces Fecal Bifidobacteria.,"INTRODUCTION


The low FODMAP diet (LFD) reduces symptoms and bifidobacteria in irritable bowel syndrome (IBS). β-galactooligosaccharides (B-GOS) may reduce the symptoms and increase bifidobacteria in IBS. We investigated whether B-GOS supplementation alongside the LFD improves IBS symptoms while preventing the decline in bifidobacteria.
METHODS


We performed a randomized, placebo-controlled, 3-arm trial of 69 Rome III adult patients with IBS from secondary care in the United Kingdom. Patients were randomized to a sham diet with placebo supplement (control) or LFD supplemented with either placebo (LFD) or 1.4 g/d B-GOS (LFD/B-GOS) for 4 weeks. Gastrointestinal symptoms, fecal microbiota (fluorescent in situ hybridization and 16S rRNA sequencing), fecal short-chain fatty acids (gas-liquid chromatography) and pH (probe), and urine metabolites (H NMR) were analyzed.
RESULTS


At 4 weeks, adequate symptom relief was higher in the LFD/B-GOS group (16/24, 67%) than in the control group (7/23, 30%) (odds ratio 4.6, 95% confidence interval: 1.3-15.6; P = 0.015); Bifidobacterium concentrations (log10 cells/g dry weight) were not different between LFD and LFD/B-GOS but were lower in the LFD/B-GOS (9.49 [0.73]) than in the control (9.77 [0.41], P = 0.018). A proportion of Actinobacteria was lower in LFD (1.9%, P = 0.003) and LFD/B-GOS (1.8%, P < 0.001) groups than in the control group (4.2%). Fecal butyrate was lower in the LFD (387.3, P = 0.028) and LFD/B-GOS (346.0, P = 0.007) groups than in the control group (609.2).
DISCUSSION


The LFD combined with B-GOS prebiotic produced a greater symptom response than the sham diet plus placebo, but addition of 1.4 g/d B-GOS did not prevent the reduction of bifidobacteria. The LFD reduces fecal Actinobacteria and butyrate thus strict long-term use should not be advised.",2020,"A proportion of Actinobacteria was lower in LFD (1.9%, P = 0.003) and LFD/B-GOS (1.8%, P < 0.001) groups than in the control group (4.2%).","['69 Rome III adult patients with IBS from secondary care in the United Kingdom', 'irritable bowel syndrome (IBS']","['β-Galactooligosaccharide', 'β-galactooligosaccharides (B-GOS', 'sham diet with placebo supplement (control) or LFD supplemented with either placebo (LFD', 'Low FODMAP Diet', 'low FODMAP diet (LFD', 'LFD combined with B-GOS prebiotic', 'placebo']","['Bifidobacterium concentrations', 'Fecal butyrate', 'LFD/B-GOS', 'IBS symptoms', 'adequate symptom relief', 'Gastrointestinal symptoms, fecal microbiota (fluorescent in situ hybridization and 16S rRNA sequencing), fecal short-chain fatty acids (gas-liquid chromatography) and pH (probe), and urine metabolites (H NMR', 'reduction of bifidobacteria', 'symptom response']","[{'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4728066', 'cui_str': 'Low FODMAP diet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C4728066', 'cui_str': 'Low FODMAP diet'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0162789', 'cui_str': 'Fluorescence in situ hybridization'}, {'cui': 'C0035702', 'cui_str': '16S Ribosomal RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0008556', 'cui_str': 'Gas liquid chromatography measurement'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0915586,"A proportion of Actinobacteria was lower in LFD (1.9%, P = 0.003) and LFD/B-GOS (1.8%, P < 0.001) groups than in the control group (4.2%).","[{'ForeName': 'Bridgette', 'Initials': 'B', 'LastName': 'Wilson', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Tokuwa', 'Initials': 'T', 'LastName': 'Kanno', 'Affiliation': ""King's College London, Institute of Pharmaceutical Science, London, United Kingdom.""}, {'ForeName': 'Gareth C', 'Initials': 'GC', 'LastName': 'Parkes', 'Affiliation': 'Department of Gastroenterology, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': ""Department of Gastroenterology, Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'A James', 'Initials': 'AJ', 'LastName': 'Mason', 'Affiliation': ""King's College London, Institute of Pharmaceutical Science, London, United Kingdom.""}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Irving', 'Affiliation': ""Department of Gastroenterology, Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Lomer', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000641']
2828,32433194,"Comparing the Efficiency, Radiation Exposure, and Accuracy Using C-Arm versus O-Arm With 3D Navigation in Placement of Transiliac-Transsacral and Iliosacral Screws: A Cadaveric Study Evaluating an Early Career Surgeon.","OBJECTIVES


To compare the efficiency, radiation exposure to surgeon and patient, and accuracy of C-arm versus O-arm with navigation in the placement of transiliac-transsacral and iliosacral screws by an orthopaedic trauma fellow, for a surgeon early in practice.
METHODS


Twelve fresh frozen cadavers were obtained. Preoperative computed tomography scans were reviewed to assess for safe corridors in the S1 and S2 segments. Iliosacral screws were assigned to the S1 segment in dysmorphic pelvises. Screws were randomized to modality and laterality. An orthopaedic trauma fellow placed all screws. Time of procedure and radiation exposure to the cadaver and surgeon were recorded. Three fellowship-trained orthopaedic trauma surgeons rated the safety of each screw on postoperative computed tomography scan.
RESULTS


Six normal and 6 dysmorphic pelvises were identified. Eighteen transiliac-transsacral screws and 6 iliosacral screws were distributed evenly between C-arm and O-arm. Average operative duration per screw was significantly shorter using C-arm compared with O-arm (15.7 minutes ± 6.1 vs. 23.7 ± 8.5, P = 0.014). Screw placement with C-arm exposed the surgeon to a significantly greater amount of radiation (3.87 × 10 rads vs. 0.32 × 10, P < 0.001) while O-arm exposed the cadaver to a significantly greater amount of radiation (0.03 vs. 2.76 rads, P < 0.001). Two S2 transiliac-transsacral screws (1 C-arm and 1 O-arm) were categorized as unsafe based on scoring. There was no difference in screw accuracy between modalities.
CONCLUSIONS


A difference in accuracy between modalities could not be elucidated, whereas efficiency was improved with utilization of C-arm, with statistical significance. A statistically significant increase in radiation exposure to the surgeon using C-arm was found, which may be clinically significant over a career. The results of this study can be extrapolated to a fellow or surgeon early in practice. The decision between use of these modalities will vary depending on surgeon preference and hospital resources.",2020,"Screw placement with C-arm exposed the surgeon to a significantly greater amount of radiation (3.87 × 10 rads vs. 0.32 × 10, P < 0.001) while O-arm exposed the cadaver to a significantly greater amount of radiation (0.03 vs. 2.76 rads, P < 0.001).","['Eighteen transiliac-transsacral screws and 6 iliosacral screws', 'Twelve fresh frozen cadavers were obtained']","['C-Arm versus O-Arm', 'C-arm versus O-arm with navigation', '3D Navigation', 'Preoperative computed tomography scans']","['radiation exposure', 'screw accuracy', 'amount of radiation', 'Average operative duration per screw']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0589469', 'cui_str': 'Transsacral approach'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",12.0,0.0365087,"Screw placement with C-arm exposed the surgeon to a significantly greater amount of radiation (3.87 × 10 rads vs. 0.32 × 10, P < 0.001) while O-arm exposed the cadaver to a significantly greater amount of radiation (0.03 vs. 2.76 rads, P < 0.001).","[{'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Araiza', 'Affiliation': 'Department of Orthopaedic Surgery, Wake Forest Baptist Medical Center, Winston Salem, NC.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Medda', 'Affiliation': ''}, {'ForeName': 'Johannes F', 'Initials': 'JF', 'LastName': 'Plate', 'Affiliation': ''}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Marquez-Lara', 'Affiliation': ''}, {'ForeName': 'Amy P', 'Initials': 'AP', 'LastName': 'Trammell', 'Affiliation': ''}, {'ForeName': 'Fernando S', 'Initials': 'FS', 'LastName': 'Aran', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lara', 'Affiliation': ''}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Danelson', 'Affiliation': ''}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Halvorson', 'Affiliation': ''}, {'ForeName': 'Eben A', 'Initials': 'EA', 'LastName': 'Carroll', 'Affiliation': ''}, {'ForeName': 'Holly T', 'Initials': 'HT', 'LastName': 'Pilson', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001724']
2829,32433277,Enhanced Recovery after Lumbar Spine Fusion: A Randomized Controlled Trial to Assess the Quality of Patient Recovery.,"BACKGROUND


Prospective trials of enhanced recovery after spine surgery are lacking. We tested the hypothesis that an enhanced recovery pathway improves quality of recovery after one- to two-level lumbar fusion.
METHODS


A patient- and assessor-blinded trial of 56 patients randomized to enhanced recovery (17 evidence-based pre-, intra-, and postoperative care elements) or usual care was performed. The primary outcome was Quality of Recovery-40 score (40 to 200 points) at postoperative day 3. Twelve points defined the clinically important difference. Secondary outcomes included Quality of Recovery-40 at days 0 to 2, 14, and 56; time to oral intake and discharge from physical therapy; length of stay; numeric pain scores (0 to 10); opioid consumption (morphine equivalents); duration of intravenous patient-controlled analgesia use; complications; and markers of surgical stress (interleukin 6, cortisol, and C-reactive protein).
RESULTS


The analysis included 25 enhanced recovery patients and 26 usual care patients. Significantly higher Quality of Recovery-40 scores were found in the enhanced recovery group at postoperative day 3 (179 ± 14 vs. 170 ± 16; P = 0.041) without reaching the clinically important difference. There were no significant differences in recovery scores at days 0 (175 ± 16 vs. 162 ± 22; P = 0.059), 1 (174 ± 18 vs. 164 ± 15; P = 0.050), 2 (174 ± 18 vs. 167 ± 17; P = 0.289), 14 (184 ± 13 vs. 180 ± 12; P = 0.500), and 56 (187 ± 14 vs. 190 ± 8; P = 0.801). In the enhanced recovery group, subscores on the Quality of Recovery-40 comfort dimension were higher (longitudinal mean score difference, 4; 95% CI, 1, 7; P = 0.008); time to oral intake (-3 h; 95% CI, -6, -0.5; P = 0.010); and duration of intravenous patient-controlled analgesia (-11 h; 95% CI, -19, -6; P < 0.001) were shorter; opioid consumption was lower at day 1 (-57 mg; 95% CI, -130, -5; P = 0.030) without adversely affecting pain scores (-2; 95% CI, -3, 0; P = 0.005); and C-reactive protein was lower at day 3 (6.1; 95% CI, 3.8, 15.7 vs. 15.9; 95% CI, 6.6, 19.7; P = 0.037).
CONCLUSIONS


Statistically significant gains in early recovery were achieved by an enhanced recovery pathway. However, significant clinical impact was not demonstrated. : WHAT WE ALREADY KNOW ABOUT THIS TOPIC: Recovery from surgery may be improved by optimizing pre-, intra-, and postoperative management.Enhanced recovery pathways involving spine surgery have scarcely been evaluated.
WHAT THIS ARTICLE TELLS US THAT IS NEW


Use of an enhanced recovery pathway for patients undergoing one- or two-level lumbar spinal fusion was associated with higher (better) Quality of Recovery-40 scores 3 days after surgery. This difference was not deemed clinically significant, however.Several secondary endpoints including time to oral intake, duration of patient-controlled analgesia use, and day 1 opioid consumption were improved by use of the enhanced recovery pathway.Further refinement of enhanced recovery strategies for spinal surgery is required.",2020,Significantly higher Quality of Recovery-40 scores were found in the enhanced recovery group at postoperative day 3 (179 ± 14 vs. 170 ± 16; P = 0.041) without reaching the clinically important difference.,"['56 patients randomized to enhanced recovery (17 evidence-based pre-, intra-, and postoperative care elements) or usual care was performed', '25 enhanced recovery patients and 26 usual care patients', 'patients undergoing one- or two-level lumbar spinal fusion', 'Lumbar Spine Fusion']",[],"['pain scores', 'time to oral intake', 'shorter; opioid consumption', 'Quality of Recovery-40 comfort dimension', 'Quality of Recovery-40 at days 0 to 2, 14, and 56; time to oral intake and discharge from physical therapy; length of stay; numeric pain scores (0 to 10); opioid consumption (morphine equivalents); duration of intravenous patient-controlled analgesia use; complications; and markers of surgical stress (interleukin 6, cortisol, and C-reactive protein', 'quality of recovery', 'duration of intravenous patient-controlled analgesia', 'time to oral intake, duration of patient-controlled analgesia use, and day 1 opioid consumption', 'Quality of Recovery-40 score', 'Quality of Patient Recovery', 'recovery scores', 'C-reactive protein', 'Quality of Recovery-40 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}]",[],"[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",56.0,0.363217,Significantly higher Quality of Recovery-40 scores were found in the enhanced recovery group at postoperative day 3 (179 ± 14 vs. 170 ± 16; P = 0.041) without reaching the clinically important difference.,"[{'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Soffin', 'Affiliation': 'From the Departments of Anesthesiology, Critical Care and Pain Management, (E.M.S., J.D.B., A.T., M.U., C.R.G., J.A.N., I.F.A., S.G.M.) Orthopedic Surgery (R.C.H., H.-J.K., F.P.C., F.J.S.) the Biostatistics Core (H.Z.), Hospital for Special Surgery, New York, New York; and Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Beckman', 'Affiliation': ''}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Tseng', 'Affiliation': ''}, {'ForeName': 'Haoyan', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': ''}, {'ForeName': 'Russel C', 'Initials': 'RC', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Urban', 'Affiliation': ''}, {'ForeName': 'Carrie R', 'Initials': 'CR', 'LastName': 'Guheen', 'Affiliation': ''}, {'ForeName': 'Han-Jo', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Cammisa', 'Affiliation': ''}, {'ForeName': 'Jemiel A', 'Initials': 'JA', 'LastName': 'Nejim', 'Affiliation': ''}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Schwab', 'Affiliation': ''}, {'ForeName': 'Isabel F', 'Initials': 'IF', 'LastName': 'Armendi', 'Affiliation': ''}, {'ForeName': 'Stavros G', 'Initials': 'SG', 'LastName': 'Memtsoudis', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003346']
2830,32433308,Outcomes of Obese Patients Bridged to Heart Transplantation with a Left Ventricular Assist Device.,"The current study aims to investigate the impact of left ventricular assist device (LVAD) implantation on weight loss and functional status in obese patients bridged to transplantation (BTT). The United Network for Organ Sharing (UNOS) database was queried to identify patients with body mass index (BMI) ≥ 30 who underwent LVAD implantation as BTT from 2008 to 2018. Patients were divided into three groups based the World Health Organization classification of obesity: obesity class I (BMI, 30.0-34.9 kg/m), obesity class II (BMI, 35-39.9 kg/m), and obesity class III (BMI, >40 kg/m). Patients with incomplete data on BMI were excluded. The primary outcome was a change in BMI while listed. Secondary outcomes included a change in functional status after LVAD implantation and posttransplant morbidity and survival. Out of 14,191 patients who had an LVAD while listed within the study period, 5,354 (37.7%) had a BMI ≥30 kg/m. Obesity was classified as class I in 3,909 (73%), class II in 1,275 (23.8%), and class III in 170 (3.2%) patients. Among patients with complete data on BMI, 18.9% (n = 394) reported a change in BMI, leading to an improvement in their obesity class, and this was similar for all obesity classes (22% [n = 331], 50% [n = 111], and 60% [n = 43] for classes I, II, and III, respectively). All groups reported an improvement in functional status (65% vs. 62% and 61% for classes I, II, and III, respectively). Posttransplant survival was not significantly different between obese groups (p = 0.787). Compared with classes I and II, the incidence of thrombosis (p = 0.0006) and device malfunction (p = 0.036) was significantly higher in the class III group. About one out of every five obese patients listed for heart transplantation with an LVAD loses weight, leading to a change in their BMI class. Most patients reported a significant improvement in their functional status. Among those successfully BTT, posttransplant survival was similar.",2020,Posttransplant survival was not significantly different between obese groups (p = 0.787).,"['five obese patients listed for heart transplantation with an LVAD loses weight, leading to a change in their BMI class', 'Obese Patients Bridged to Heart Transplantation with a Left Ventricular Assist Device', 'Patients were divided into three groups based the World Health Organization classification of obesity: obesity class', 'Patients with incomplete data on BMI were excluded', '14,191 patients who had an LVAD while listed within the study period, 5,354 (37.7%) had a BMI ≥30 kg/m', 'patients with complete data on BMI, 18.9% (n = 394', 'obese patients bridged to transplantation (BTT']",['left ventricular assist device (LVAD) implantation'],"['change in functional status after LVAD implantation and posttransplant morbidity and survival', 'change in BMI', 'posttransplant survival', 'incidence of thrombosis', 'Posttransplant survival', 'functional status', 'weight loss and functional status', 'device malfunction']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1504465', 'cui_str': 'Device malfunction'}]",14191.0,0.0310568,Posttransplant survival was not significantly different between obese groups (p = 0.787).,"[{'ForeName': 'Alexis K', 'Initials': 'AK', 'LastName': 'Okoh', 'Affiliation': 'From the Cardiovascular Research Unit, RWJ Barnabas Health, Newark Beth Israel Medical Center, Newark, New Jersey.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Selevany', 'Affiliation': 'From the Cardiovascular Research Unit, RWJ Barnabas Health, Newark Beth Israel Medical Center, Newark, New Jersey.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Heaton', 'Affiliation': 'From the Cardiovascular Research Unit, RWJ Barnabas Health, Newark Beth Israel Medical Center, Newark, New Jersey.'}, {'ForeName': 'Nawar', 'Initials': 'N', 'LastName': 'Al-Obaidi', 'Affiliation': 'From the Cardiovascular Research Unit, RWJ Barnabas Health, Newark Beth Israel Medical Center, Newark, New Jersey.'}, {'ForeName': 'Darko', 'Initials': 'D', 'LastName': 'Vucicevic', 'Affiliation': 'From the Cardiovascular Research Unit, RWJ Barnabas Health, Newark Beth Israel Medical Center, Newark, New Jersey.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Tayal', 'Affiliation': 'From the Cardiovascular Research Unit, RWJ Barnabas Health, Newark Beth Israel Medical Center, Newark, New Jersey.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Zucker', 'Affiliation': 'From the Cardiovascular Research Unit, RWJ Barnabas Health, Newark Beth Israel Medical Center, Newark, New Jersey.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Camacho', 'Affiliation': 'From the Cardiovascular Research Unit, RWJ Barnabas Health, Newark Beth Israel Medical Center, Newark, New Jersey.'}, {'ForeName': 'Leonard Y', 'Initials': 'LY', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiothoracic Surgery, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Russo', 'Affiliation': 'Division of Cardiothoracic Surgery, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.'}]",ASAIO journal (American Society for Artificial Internal Organs : 1992),['10.1097/MAT.0000000000001188']
2831,32433510,A trial comparing continuous positive airway pressure (CPAP) devices in preterm infants.,"OBJECTIVE


To test the hypothesis that infants born <30 weeks' gestation supported by Seattle-PAP will have lower rates of continuous positive airway pressure (CPAP) failure than infants supported with conventional, Fisher&Paykel-CPAP (FP-CPAP).
STUDY DESIGN


Randomized trial (3/2017-01/2019) at 5 NICUs. The primary outcome was CPAP failure; subgroup analyses (gestational age, receipt antenatal corticosteroids) were performed.
RESULTS


A total of 232 infants were randomized. Infants in the Seattle-PAP and FP-CPAP groups had mean gestational ages of 27.0 and 27.2 weeks, respectively. We observed no differences in rates of treatment failure between Seattle-PAP (40/112, 35.7%) and FP-CPAP (38/120, 31.7%; risk difference, 4.1%; 95% CI, -8.1-16.2; P = 0.51). Subgroup analysis indicated no differences in rates of CPAP failure. We observed no differences between the two groups in frequencies of adverse events or duration of respiratory support.
CONCLUSIONS


Among infants born <30 weeks' gestation, rates of CPAP failure did not differ between Seattle-PAP and FP-CPAP.",2020,"Among infants born <30 weeks' gestation, rates of CPAP failure did not differ between Seattle-PAP and FP-CPAP.","['232 infants were randomized', ""infants born <30 weeks' gestation"", 'preterm infants']",['continuous positive airway pressure (CPAP) devices'],"['rates of treatment failure', 'rates of CPAP failure', 'CPAP failure; subgroup analyses (gestational age, receipt antenatal corticosteroids', 'FP-CPAP', 'continuous positive airway pressure (CPAP) failure']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",232.0,0.309661,"Among infants born <30 weeks' gestation, rates of CPAP failure did not differ between Seattle-PAP and FP-CPAP.","[{'ForeName': 'Carl H', 'Initials': 'CH', 'LastName': 'Backes', 'Affiliation': ""Center for Perinatal Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, USA. Carl.backesjr@nationwidechildrens.org.""}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Cooper', 'Affiliation': 'Department of Pediatrics, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Notestine', 'Affiliation': ""Center for Perinatal Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Crystal M', 'Initials': 'CM', 'LastName': 'Alfred', 'Affiliation': 'Department of Pediatrics, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Molly K', 'Initials': 'MK', 'LastName': 'Ball', 'Affiliation': 'Department of Pediatrics, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Rivera', 'Affiliation': ""Center for Perinatal Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Lamp', 'Affiliation': ""Center for Perinatal Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Marzec', 'Affiliation': ""Center for Perinatal Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Stenger', 'Affiliation': 'Department of Pediatrics, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Mohannad', 'Initials': 'M', 'LastName': 'Moallem', 'Affiliation': 'Department of Pediatrics, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Randy R', 'Initials': 'RR', 'LastName': 'Miller', 'Affiliation': 'Department of Pediatrics, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Apurwa', 'Initials': 'A', 'LastName': 'Naik', 'Affiliation': 'OhioHealth Grant Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Lindsey J', 'Initials': 'LJ', 'LastName': 'Beer', 'Affiliation': 'Department of Pediatrics, The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Howard', 'Affiliation': ""Seattle Children's Research Institute, Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Welty', 'Affiliation': ""Seattle Children's Research Institute, Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Peter Richardson', 'Affiliation': ""Seattle Children's Research Institute, Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Noah H', 'Initials': 'NH', 'LastName': 'Hillman', 'Affiliation': ""SSM Health, Cardinal Glennon Children's Hospital, St. Louis University, St. Louis, MO, USA.""}, {'ForeName': 'John A F', 'Initials': 'JAF', 'LastName': 'Zupancic', 'Affiliation': 'Division of Newborn Medicine, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Larissa I', 'Initials': 'LI', 'LastName': 'Stanberry', 'Affiliation': 'Minneapolis Heart Institute Foundation, Minneapolis, MN, USA.'}, {'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Hansen', 'Affiliation': ""Seattle Children's Research Institute, Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Charles V', 'Initials': 'CV', 'LastName': 'Smith', 'Affiliation': ""Seattle Children's Research Institute, Seattle Children's Hospital, Seattle, WA, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0690-5']
2832,32433377,Incorporating a Microlearning Wellness Intervention Into Nursing Student Curricula.,"BACKGROUND


Cultivating healthy lifestyle beliefs (HLBs) can result in positive health outcomes for students during their nursing program.
PURPOSE


The purpose of the study was to determine the effectiveness of short wellness interventions (microlearning) in nursing courses on reducing stress and anxiety and enhancing HLB.
METHODS


Microlearning wellness interventions were offered to graduate and undergraduate nursing students in this cluster randomized intervention study. The Perceived Stress Scale 4, Generalized Anxiety Disorder 7, and Healthy Lifestyle Beliefs Scales were administered. Student perceptions were evaluated using a short answer narrative.
RESULTS


The intervention group reported higher HLB (P = .15), lower anxiety (P = .06), and lower stress (P = .06) compared with the control group after adjusting for baseline differences. Student comments were favorable and included enjoying the activities, weight loss success, and mindfulness strategies.
CONCLUSIONS


Incorporating wellness interventions into nursing curricula demonstrates a positive trend toward reducing anxiety and stress and improving HLB.",2020,"The intervention group reported higher HLB (P = .15), lower anxiety (P = .06), and lower stress (P = .06) compared with the control group after adjusting for baseline differences.","['Microlearning wellness interventions were offered to graduate and undergraduate nursing students', 'students during their nursing program']",['short wellness interventions (microlearning'],"['lower stress', 'higher HLB', 'stress and anxiety and enhancing HLB', 'Perceived Stress Scale 4, Generalized Anxiety Disorder 7, and Healthy Lifestyle Beliefs Scales', 'anxiety and stress and improving HLB', 'lower anxiety', 'enjoying the activities, weight loss success, and mindfulness strategies']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0193499,"The intervention group reported higher HLB (P = .15), lower anxiety (P = .06), and lower stress (P = .06) compared with the control group after adjusting for baseline differences.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Gawlik', 'Affiliation': 'Author Affiliations: Assistant Professor of Clinical Nursing (Dr Gawlik), Biostatistician 1 (Dr Guo), Research Associate Professor (Dr Tan), and Professor of Clinical Nursing (Dr Overcash), The Ohio State University, College of Nursing, Columbus.'}, {'ForeName': 'Jinghong', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Alai', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Overcash', 'Affiliation': ''}]",Nurse educator,['10.1097/NNE.0000000000000842']
2833,32433378,A Combination of Self-debriefing and Instructor-Led Debriefing Improves Team Effectiveness in Health Science Students.,"BACKGROUND


Debriefing is considered a critical component of simulation-based learning, but the differences between different debriefing methods remain unclear.
PURPOSE


The purpose of the study was to investigate the effectiveness of the debriefing assessment, problem-solving process, and team effectiveness among students who received instructor-led debriefing, self-debriefing, and combined debriefing.
METHODS


An experimental design was conducted with 250 students (nursing, physiotherapy, and occupational therapy). Differences in the Debriefing Experience Scale (DES), Problem Solving Inventory (PSI), and Communication and Teamwork Skills (CATS) assessment between the groups were measured.
RESULTS


In nursing students, the combined debriefing group had the highest scores for the CATS assessment (P < .001) and for the coordination (P < .001), cooperation (P = .012), and communication (P = .002) categories. No significant differences were observed between debriefing groups for DES or PSI.
CONCLUSIONS


Combined debriefing improves communication and team skills in students. Educators might promote combined debriefing after simulation sessions as it seems to improve team effectiveness.",2020,"In nursing students, the combined debriefing group had the highest scores for the CATS assessment (P < .001) and for the coordination (P < .001), cooperation (P = .012), and communication (P = .002) categories.","['students', 'Health Science Students', 'students who received', '250 students (nursing, physiotherapy, and occupational therapy']","['Self-debriefing and Instructor-Led Debriefing', 'instructor-led debriefing, self-debriefing, and combined debriefing']","['communication and team skills', 'Debriefing Experience Scale (DES), Problem Solving Inventory (PSI), and Communication and Teamwork Skills (CATS) assessment']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",250.0,0.0302018,"In nursing students, the combined debriefing group had the highest scores for the CATS assessment (P < .001) and for the coordination (P < .001), cooperation (P = .012), and communication (P = .002) categories.","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Rueda-Medina', 'Affiliation': 'Author Affiliations: Professor, (Dr Rueda-Medina), Associate Professors, (Drs Gómez-Urquiza, Molina-Rivas, and Correa-Rodríguez), Nursing Department at the University of Granada; Associate Professors, (Tapia-Haro, and Aguilar-Ferrándiz), Physical Therapy Department at the University of Granada, Spain.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Gómez-Urquiza', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Molina-Rivas', 'Affiliation': ''}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Tapia-Haro', 'Affiliation': ''}, {'ForeName': 'María Encarnación', 'Initials': 'ME', 'LastName': 'Aguilar-Ferrándiz', 'Affiliation': ''}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Correa-Rodríguez', 'Affiliation': ''}]",Nurse educator,['10.1097/NNE.0000000000000845']
2834,32433428,Preoperative Carbohydrate Drinks Do Not Decrease Postoperative Nausea and Vomiting in Type 2 Diabetic Patients Undergoing Total Knee Arthroplasty-A Randomized Controlled Trial.,"INTRODUCTION


We evaluated whether preoperative carbohydrate drink would be able to decrease postoperative nausea and vomiting (PONV) and improve the quality of recovery (QoR) in diabetic patients undergoing total knee arthroplasty (TKA).
METHODS


Eighty-two patients were randomized to either the intravenous (IV) Dextrose group (n = 41) or Oral carbohydrate (CHO) group (n = 41). The IV Dextrose group received dextrose solution mixed with insulin while fasting, and the Oral CHO group received carbohydrate drinks preoperatively. PONV was assessed up to postoperative 36 hours, and QoR was assessed before surgery and on postoperative day (POD) 1. Blood glucose was measured from the morning of surgery until POD 1.
RESULTS


PONV scores were not different between the groups. Postoperative QoR scores were significantly higher in the Oral CHO group (median [interquartile range]; 160 [153 to 167]) than the IV Dextrose group (155 [147 to 159]) (P = 0.009), but the difference did not meet the minimal clinically important difference. Blood glucose was comparable between the groups.
DISCUSSION


Preoperative CHO drink did not reduce PONV in diabetic patients after total knee arthroplasty. A statistically significant but clinically questionable improvement in the QoR was seen in the Oral CHO group. However, preoperative CHO drink did not increase hyperglycemia, which suggests that it may be a safe component of perioperative care in diabetic patients.",2020,"Blood glucose was comparable between the groups.
","['diabetic patients after total knee arthroplasty', 'Type 2 Diabetic Patients Undergoing Total Knee Arthroplasty', 'diabetic patients', 'Eighty-two patients', 'diabetic patients undergoing total knee arthroplasty (TKA']","['Preoperative Carbohydrate Drinks', 'Oral CHO', 'dextrose solution mixed with insulin while fasting, and the Oral CHO group received carbohydrate drinks preoperatively', 'preoperative carbohydrate drink', 'intravenous (IV) Dextrose', 'Preoperative CHO drink', 'Oral carbohydrate (CHO']","['postoperative nausea and vomiting (PONV', 'quality of recovery (QoR', 'PONV scores', 'Postoperative Nausea and Vomiting', 'PONV', 'QoR', 'Postoperative QoR scores', 'hyperglycemia', 'Blood glucose']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",82.0,0.0793411,"Blood glucose was comparable between the groups.
","[{'ForeName': 'Seokyung', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine (Dr. Seokyung Shin, Dr. Choi, Dr. Kang, and Dr. Kim), the Anesthesia and Pain Research Institute (Dr. Seokyung Shin, Dr. Choi, Dr. Kang, and Dr. Kim), Yonsei University College of Medicine, the Department of Research Affairs (Dr. Hyejung Shin), Biostatistics Collaboration Unit, Yonsei University College of Medicine, and the Department of Orthopedic Surgery (Dr. Yang, Dr. Park, and Dr. Kwon), Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yong Seon', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Hyejung', 'Initials': 'H', 'LastName': 'Shin', 'Affiliation': ''}, {'ForeName': 'Ick Hwan', 'Initials': 'IH', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Kwan Kyu', 'Initials': 'KK', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hyuck Min', 'Initials': 'HM', 'LastName': 'Kwon', 'Affiliation': ''}, {'ForeName': 'Byunghag', 'Initials': 'B', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'So Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': ''}]",The Journal of the American Academy of Orthopaedic Surgeons,['10.5435/JAAOS-D-20-00089']
2835,31838256,Results of the CYP-GUIDES randomized controlled trial: Total cohort and primary endpoints.,"CYP-GUIDES (Cytochrome Psychotropic Genotyping Under Investigation for Decision Support) is a randomized controlled trial (RCT) comparing 2 outcomes in hospitalized patients with major depressive disorder (MDD) treated according to the patient's CYP2D6 genotype and functional status versus standard psychotropic therapy. The primary outcome was hospital Length of Stay (LOS) and the secondary outcome was the Re-Admission Rate (RAR) 30 days after discharge. The trial setting was the Institute of Living at Hartford Hospital. CYP2D6 genotyping was implemented to detect common polymorphisms resulting in an enzyme with sub-normal, normal or supra-normal function. The electronic medical record (EMR) was utilized to transmit clinically actionable drug prescribing guidance based on the patient's CYP2D6 genotype to the physician. The RCT recruited 1500 patients, genotyped CYP2D6 in 1459, and randomized 477 to standard therapy (Group S), for whom treatment-as-usual guidance was delivered without consideration of patient CYP2D6 genotype, and 982 to genetically-guided therapy (Group G) where CYP2D6-based treatment recommendations were provided via EMR to physicians. For inpatients in Group G whose CYP2D6 function was sub- or supra-normal, medications primarily metabolized by the CYP2D6 enzyme were proscribed. The RCT developed a database of potential benefit to the field. The genetic, pharmacologic and clinical information is being simultaneously published. Results did not reveal differences in LOS or RAR between Group G and Group S, but confounders may have obscured the effects of pharmacogenetic guidance. We present strategies to assess effects of pharmacogenetic guidance on the most vulnerable patients at either extreme of CYP2D6 function treated with multiple psychotropics.",2020,"Results did not reveal differences in LOS or RAR between Group G and Group S, but confounders may have obscured the effects of pharmacogenetic guidance.","['vulnerable patients at either extreme of CYP2D6 function treated with multiple psychotropics', 'hospitalized patients with major depressive disorder (MDD']","['CYP-GUIDES (Cytochrome Psychotropic', 'standard psychotropic therapy']","['hospital Length of Stay (LOS', 'LOS or RAR', 'Re-Admission Rate (RAR', 'CYP2D6 function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0057223', 'cui_str': 'CYP2D6'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0010798', 'cui_str': 'Cytochromes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1264195', 'cui_str': 'Refractory anemia with ringed sideroblasts (disorder)'}, {'cui': 'C0057223', 'cui_str': 'CYP2D6'}, {'cui': 'C0031843', 'cui_str': 'function'}]",1500.0,0.0962851,"Results did not reveal differences in LOS or RAR between Group G and Group S, but confounders may have obscured the effects of pharmacogenetic guidance.","[{'ForeName': 'Gualberto', 'Initials': 'G', 'LastName': 'Ruaño', 'Affiliation': 'Institute of Living at Hartford Hospital, Genomas Laboratory of Personalized Health, 67 Jefferson Street, Hartford, CT 06106, United States. Electronic address: gualberto.ruano@hhchealth.org.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Research Administration, Hartford Hospital, 80 Seymour Street, Hartford, CT 06102, United States. Electronic address: saskia.robinson@hhchealth.org.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Holford', 'Affiliation': 'Yale School of Public Health, Yale University, 1 Church Street, 6th Floor Suite, New Haven, CT 06510, United States. Electronic address: theodore.holford@yale.edu.'}, {'ForeName': 'Raveen', 'Initials': 'R', 'LastName': 'Mehendru', 'Affiliation': 'Institute of Living at Hartford Hospital, 200 Retreat Avenue, Hartford, CT 06114, United States. Electronic address: raveen.mehendru@hhchealth.org.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'IInformation Technology Services, Hartford Healthcare, 5 Batterson Park Road, Farmington, CT 06032, United States. Electronic address: seth.baker@hhchealth.org.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Tortora', 'Affiliation': 'Research Administration, Hartford Hospital, 80 Seymour Street, Hartford, CT 06102, United States. Electronic address: joseph.tortora@hhchealth.org.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Goethe', 'Affiliation': 'Private Medical Practice, 155 Ayrshire Lane, Avon, CT 06001, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105910']
2836,32433572,Effect of antiseptic gels in the microbiologic colonization of the suture threads after oral surgery.,"Three different bioadhesive gels were evaluated in a double-blind randomized clinical trial in which microbial growth in the suture thread was assessed following post-surgical application of the aforementioned gels. Also assessed in this trial were, the intensity of post-surgical pain as well as the degree of healing of the patients' surgical wounds. A total of 21 patients (with 42 wisdom teeth) participated in this trial. Chlorhexidine gel, chlorhexidine-chitosan gel, and hyaluronic acid gel were evaluated, with a neutral water-based gel serving as the control agent. The aerobic and facultative anaerobic bacterial recovery on blood agar was lower in the placebo group than in the experimental groups. The most significant difference (p = 0.04) was observed in the chlorhexidine-chitosan group. in which the growth of Blood Agar and Mitis Salivarius Agar was significantly higher than in the placebo group. The intensity of post-surgical pain was very similar among all the groups. Significantly better healing rates were observed in the patients treated with chlorhexidine-chitosan gel when compared with those who used the placebo gel (p = 0.03), and in particular when compared with those patients who used hyaluronic acid gel (p = 0.01). Through our microbiological analyses, we were able to conclude that none of the bioadhesive gels tested resulted in beneficial reductions in the bacterial/fungal populations. However, the healing rates of patients who were treated with chlorhexidine-chitosan were better than those of the patients who used either the placebo gel or the hyaluronic acid gel.",2020,"Significantly better healing rates were observed in the patients treated with chlorhexidine-chitosan gel when compared with those who used the placebo gel (p = 0.03), and in particular when compared with those patients who used hyaluronic acid gel (p = 0.01).","['21 patients (with 42 wisdom teeth', 'microbiologic colonization of the suture threads after oral surgery']","['chlorhexidine-chitosan gel', 'placebo gel or the hyaluronic acid gel', 'hyaluronic acid gel', 'chlorhexidine', 'Chlorhexidine gel, chlorhexidine-chitosan gel, and hyaluronic acid gel', 'chlorhexidine-chitosan', 'antiseptic gels', 'placebo']","['blood agar', 'intensity of post-surgical pain', 'Blood Agar and Mitis Salivarius Agar', 'healing rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}]","[{'cui': 'C3266603', 'cui_str': 'Blood agar'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001771', 'cui_str': 'Agar'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",21.0,0.0631417,"Significantly better healing rates were observed in the patients treated with chlorhexidine-chitosan gel when compared with those who used the placebo gel (p = 0.03), and in particular when compared with those patients who used hyaluronic acid gel (p = 0.01).","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Rodríguez Zorrilla', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit (MedOralRes). School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain. samuel.rodriguez.zorrilla@outlook.com.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Blanco Carrión', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit (MedOralRes). School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'García García', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit (MedOralRes). School of Medicine and Dentistry. Health Research Institute of Santiago (IDIS), Santiago de Compostela, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Galindo Moreno', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Xabier', 'Initials': 'X', 'LastName': 'Marichalar Mendía', 'Affiliation': 'Department of Stomatology II. School of Medicine and Dentistry, Leioa, Bizkaia, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Seoane Prado', 'Affiliation': 'Microbiology Unit. School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Pérez Estévez', 'Affiliation': 'Microbiology Unit. School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Pérez-Sayáns', 'Affiliation': 'Oral Medicine, Oral Surgery and Implantology Unit (MedOralRes). School of Medicine and Dentistry. Health Research Institute of Santiago (IDIS), Santiago de Compostela, Spain.'}]",Scientific reports,['10.1038/s41598-020-65007-y']
2837,31506369,Sources of Error in Office Blood Pressure Measurement.,"PURPOSES


To evaluate 2 commonly overlooked sources of error in measuring blood pressure (BP) in the office, improper patient positioning and frequency of terminal digit bias (TDB) using manual and automated (BP) devices.
METHODS


BPs recorded by 3 nurses using manual and automated devices were analyzed for TDB. In the next part of the study, 294 patients were recruited and tested with each patient's BP measured twice in the table position and compared with BP measured in the chair position. To eliminate concern for position sequence, a randomized controlled trial was initially conducted.
RESULTS


Significant TDB for the digit zero was identified in BPs measured by all nurses using a manual device. No such bias was identified for any nurse when measuring BP with an automated device. For the positional study, the randomized controlled study showed no significant sequencing effect therefore the sequence of table then chair BP measurements was adopted. Significant BP lowering was observed in 128 patients (42.7%) in the chair compared with the table position. Misclassification of prehypertension and hypertension would have occurred in 15.3% and 16% of patients, respectively, when BP was recorded in the table instead of the chair position.
CONCLUSIONS


Significant TDB was identified for all nurses when using a manual but not an automated device. Patient positioning on the examination table resulted in elevations of systolic and diastolic BPs.",2019,Significant BP lowering was observed in 128 patients (42.7%) in the chair compared with the table position.,['294 patients'],[],"['Misclassification of prehypertension and hypertension', 'Significant BP lowering', 'blood pressure (BP', 'elevations of systolic and diastolic BPs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C1696708', 'cui_str': 'Pre-Hypertension'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",294.0,0.0684168,Significant BP lowering was observed in 128 patients (42.7%) in the chair compared with the table position.,"[{'ForeName': 'Roy N', 'Initials': 'RN', 'LastName': 'Morcos', 'Affiliation': 'From the Department of Family and Community Medicine, Northeast Ohio Medical University, Rootstown, OH (RNM, SK); Department of Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (RNM); Medical Decision Making Society of Youngstown Ohio, c/o Jeghers Medical Index, St. Elizabeth Youngstown Hospital, Youngstown, OH (FC, KJC); Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (SK, DS); Department of Pathology, Northeast Ohio Medical University, Rootstown, OH (KJC). Roy_Morcos@mercy.com.'}, {'ForeName': 'Kimbroe J', 'Initials': 'KJ', 'LastName': 'Carter', 'Affiliation': 'From the Department of Family and Community Medicine, Northeast Ohio Medical University, Rootstown, OH (RNM, SK); Department of Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (RNM); Medical Decision Making Society of Youngstown Ohio, c/o Jeghers Medical Index, St. Elizabeth Youngstown Hospital, Youngstown, OH (FC, KJC); Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (SK, DS); Department of Pathology, Northeast Ohio Medical University, Rootstown, OH (KJC).'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Castro', 'Affiliation': 'From the Department of Family and Community Medicine, Northeast Ohio Medical University, Rootstown, OH (RNM, SK); Department of Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (RNM); Medical Decision Making Society of Youngstown Ohio, c/o Jeghers Medical Index, St. Elizabeth Youngstown Hospital, Youngstown, OH (FC, KJC); Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (SK, DS); Department of Pathology, Northeast Ohio Medical University, Rootstown, OH (KJC).'}, {'ForeName': 'Sumira', 'Initials': 'S', 'LastName': 'Koirala', 'Affiliation': 'From the Department of Family and Community Medicine, Northeast Ohio Medical University, Rootstown, OH (RNM, SK); Department of Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (RNM); Medical Decision Making Society of Youngstown Ohio, c/o Jeghers Medical Index, St. Elizabeth Youngstown Hospital, Youngstown, OH (FC, KJC); Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (SK, DS); Department of Pathology, Northeast Ohio Medical University, Rootstown, OH (KJC).'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'From the Department of Family and Community Medicine, Northeast Ohio Medical University, Rootstown, OH (RNM, SK); Department of Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (RNM); Medical Decision Making Society of Youngstown Ohio, c/o Jeghers Medical Index, St. Elizabeth Youngstown Hospital, Youngstown, OH (FC, KJC); Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (SK, DS); Department of Pathology, Northeast Ohio Medical University, Rootstown, OH (KJC).'}, {'ForeName': 'Haroon', 'Initials': 'H', 'LastName': 'Syed', 'Affiliation': 'From the Department of Family and Community Medicine, Northeast Ohio Medical University, Rootstown, OH (RNM, SK); Department of Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (RNM); Medical Decision Making Society of Youngstown Ohio, c/o Jeghers Medical Index, St. Elizabeth Youngstown Hospital, Youngstown, OH (FC, KJC); Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (SK, DS); Department of Pathology, Northeast Ohio Medical University, Rootstown, OH (KJC).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2019.05.190085']
2838,31925340,Effect of rivaroxaban on urinary albumin excretion in patients with atrial fibrillation and chronic kidney disease: a randomized trial (X-NOAC).,,2020,,['patients with atrial fibrillation and chronic kidney disease'],['rivaroxaban'],['urinary albumin excretion'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}]",,0.0298132,,"[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan. tanakaa2@cc.saga-u.ac.jp.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiology, Yokohama Minami Kyosai Hospital, Yokohama, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Matsunaga', 'Affiliation': 'Department of Internal Medicine, Imari-Arita Kyoritsu Hospital, Matsuura, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Taguchi', 'Affiliation': 'Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Nakahara', 'Affiliation': 'Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Chihara', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Jun-Ichi', 'Initials': 'JI', 'LastName': 'Oyama', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan. node@cc.saga-u.ac.jp.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0384-6']
2839,31096266,Quantitative facial expression analysis revealed the efficacy and time course of oxytocin in autism.,"Discrepancies in efficacy between single-dose and repeated administration of oxytocin for autism spectrum disorder have led researchers to hypothesize that time-course changes in efficacy are induced by repeated administrations of the peptide hormone. However, repeatable, objective, and quantitative measurement of autism spectrum disorder's core symptoms are lacking, making it difficult to examine potential time-course changes in efficacy. We tested this hypothesis using repeatable, objective, and quantitative measurement of the core symptoms of autism spectrum disorder. We examined videos recorded during semi-structured social interaction administered as the primary outcome in single-site exploratory (n = 18, crossover within-subjects design) and multisite confirmatory (n = 106, parallel-group design), double-blind, placebo-controlled 6-week trials of repeated intranasal administrations of oxytocin (48 IU/day) in adult males with autism spectrum disorder. The main outcomes were statistical representative values of objectively quantified facial expression intensity in a repeatable part of the Autism Diagnostic Observation Schedule: the maximum probability (i.e. mode) and the natural logarithm of mode on the probability density function of neutral facial expression and the natural logarithm of mode on the probability density function of happy expression. Our recent study revealed that increases in these indices characterize autistic facial expression, compared with neurotypical individuals. The current results revealed that oxytocin consistently and significantly decreased the increased natural logarithm of mode on the probability density function of neutral facial expression compared with placebo in exploratory (effect-size, -0.57; 95% CI, -1.27 to 0.13; P = 0.023) and confirmatory trials (-0.41; -0.62 to -0.20; P < 0.001). A significant interaction between time-course (at baseline, 2, 4, 6, and 8 weeks) and the efficacy of oxytocin on the natural logarithm of mode on the probability density function of neutral facial expression was found in confirmatory trial (P < 0.001). Post hoc analyses revealed maximum efficacy at 2 weeks (P < 0.001, Cohen's d = -0.78; 95% CI, -1.21 to -0.35) and deterioration of efficacy at 4 weeks (P = 0.042, Cohen's d = -0.46; 95% CI, -0.90 to -0.01) and 6 weeks (P = 0.10, Cohen's d = -0.35; 95% CI, -0.77 to 0.08), while efficacy was preserved at 2 weeks post-treatment (i.e. 8 weeks) (P < 0.001, Cohen's d = -1.24; 95% CI, -1.71 to -0.78). Quantitative facial expression analyses successfully verified the positive effects of repeated oxytocin on autistic individuals' facial expressions and demonstrated a time-course change in efficacy. The current findings support further development of an optimized regimen of oxytocin treatment.",2019,Quantitative facial expression analyses successfully verified the positive effects of repeated oxytocin on autistic individuals' facial expressions and demonstrated a time-course change in efficacy.,"['autism spectrum disorder', 'autism', 'adult males with autism spectrum disorder']","['placebo', 'oxytocin']","[""autistic individuals' facial expressions"", 'maximum efficacy', 'statistical representative values of objectively quantified facial expression intensity in a repeatable part of the Autism Diagnostic Observation Schedule: the maximum probability (i.e. mode) and the natural logarithm of mode on the probability density function of neutral facial expression and the natural logarithm of mode on the probability density function of happy expression', 'probability density function of neutral facial expression', 'deterioration of efficacy', 'natural logarithm of mode on the probability density function of neutral facial expression']","[{'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.262735,Quantitative facial expression analyses successfully verified the positive effects of repeated oxytocin on autistic individuals' facial expressions and demonstrated a time-course change in efficacy.,"[{'ForeName': 'Keiho', 'Initials': 'K', 'LastName': 'Owada', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Okada', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Munesue', 'Affiliation': 'Research Center for Child Mental Development, Kanazawa University, 13-1 Takara-machi, Kanazawa, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Kuroda', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Fujioka', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Eiheiji, Fukui, Japan.'}, {'ForeName': 'Yota', 'Initials': 'Y', 'LastName': 'Uno', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Graduate School of Psychology, Kanazawa Institute of Technology, 7-1 Ohgigaoka, Nonoichi, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Psychiatry, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashiku, Hamamatsu City, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Mori', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Eiheiji, Fukui, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Yoshimura', 'Affiliation': 'Research Center for Child Mental Development, Kanazawa University, 13-1 Takara-machi, Kanazawa, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kawakubo', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Arioka', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kojima', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Teruko', 'Initials': 'T', 'LastName': 'Yuhi', 'Affiliation': 'Research Center for Child Mental Development, Kanazawa University, 13-1 Takara-machi, Kanazawa, Japan.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Yassin', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Kushima', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan.'}, {'ForeName': 'Seico', 'Initials': 'S', 'LastName': 'Benner', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Nanayo', 'Initials': 'N', 'LastName': 'Ogawa', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kawano', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Eriguchi', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Biostatistics Division, Clinical Research Support Center, University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Maeri', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Kano', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Kiyoto', 'Initials': 'K', 'LastName': 'Kasai', 'Affiliation': 'Department of Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Haruhiro', 'Initials': 'H', 'LastName': 'Higashida', 'Affiliation': 'Research Center for Child Mental Development, Kanazawa University, 13-1 Takara-machi, Kanazawa, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ozaki', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Kosaka', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Eiheiji, Fukui, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Yamasue', 'Affiliation': 'Department of Psychiatry, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashiku, Hamamatsu City, Japan.'}]",Brain : a journal of neurology,['10.1093/brain/awz126']
2840,31369328,"Impacts of aquatic walking on arterial stiffness, exercise tolerance, and physical function in patients with peripheral artery disease: a randomized clinical trial.","Peripheral artery disease (PAD) is an atherosclerotic disease that is associated with attenuated vascular function, cardiorespiratory capacity, physical function, and muscular strength. It is essential to combat these negative effects on health by incorporating lifestyle interventions to slow disease progression, such as exercise. We sought to examine the effects of aquatic walking exercise on cardiovascular function, cardiorespiratory capacity [maximal volume of oxygen consumption (V̇o 2max )], exercise tolerance [6-min walking distance (6MWD)], physical function, muscular strength, and body composition in patients with PAD. Patients with PAD ( n  = 72) were recruited and randomly assigned to a 12-wk aquatic walking training group (AQ,  n  = 35) or a control group (CON,  n  = 37). The AQ group performed walking and leg exercises in waist-to-chest-deep water. Leg arterial stiffness [femoral-to-ankle pulse wave velocity (legPWV)], heart rate (HR), blood pressure (BP), ankle-to-brachial index (ABI), V̇o 2max , 6MWD, physical function, muscular strength, body composition, resting metabolic rate (RMR), and flexibility were measured before and after 12 wk. There were significant group × time interactions ( P  < 0.05) after 12 wk for legPWV and HR, which significantly decreased ( P  < 0.05) in AQ, and V̇o 2max , 6MWD, physical function, and muscular strength, which significantly increased ( P  < 0.05) in AQ, compared with no changes in CON. There were no significant differences ( P  > 0.05) for BP, ABI, RMR, or flexibility after 12 wk. Interestingly, there was relatively high adherence (84%) to the aquatic walking exercise program in this population. These results suggest that aquatic walking exercise is an effective therapy to reduce arterial stiffness and resting HR and improve cardiorespiratory capacity, exercise tolerance, physical function, and muscular strength in patients with PAD. NEW & NOTEWORTHY  The results of this study reveal for the first time that aquatic walking exercise can decrease arterial stiffness and improve exercise tolerance, cardiorespiratory capacity, and muscular strength in patients with peripheral artery disease (PAD). Aquatic walking exercise training demonstrates relatively high exercise adherence in this population. Aquatic walking exercise training may be a useful therapeutic intervention for improving physical function in patients with PAD.",2019,"There were no significant differences ( p >0.05) for BP, ABI, RMR, or flexibility after 12 weeks.","['patients with PAD', 'patients with peripheral artery disease', 'Patients with PAD ( n =72']","['AQ group performed walking and leg exercises', 'aquatic walking exercise program', 'aquatic walking', 'aquatic walking training group (AQ,  n =35) or control (CON', 'aquatic walking exercise']","['cardiovascular function, cardiorespiratory capacity (VO 2 max), exercise tolerance (6-minute walking distance, 6MWD), physical function, muscular strength, and body composition', 'time interactions', 'arterial stiffness, exercise tolerance & physical function', 'BP, ABI, RMR, or flexibility', 'VO 2 max, 6MWD, physical function, and muscular strength', 'arterial stiffness and resting HR, and improve cardiorespiratory capacity, exercise tolerance, physical function, and muscular strength', 'Leg arterial stiffness (femoral-to-ankle pulse-wave velocity, legPWV), heart rate (HR), blood pressure (BP), ankle-to-brachial index (ABI), VO 2 max, 6MWD, physical function, muscular strength, body composition, resting metabolic rate (RMR), and flexibility']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0454361', 'cui_str': 'Lower limb exercises (regime/therapy)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}]",,0.02033,"There were no significant differences ( p >0.05) for BP, ABI, RMR, or flexibility after 12 weeks.","[{'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Yi-Sub', 'Initials': 'YS', 'LastName': 'Kwak', 'Affiliation': 'Department of Physical Education, Dong-Eui University, Busan, South Korea.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00209.2019']
2841,32436612,"Safety, feasibility and efficacy of side-alternating vibration therapy on bone and muscle health in children and adolescents with musculoskeletal disorders: A pilot trial.","AIMS


A pilot study was performed to establish the safety, feasibility and efficacy of vibration therapy (VT) on bone and muscle health in children and adolescents with a range of musculoskeletal disorders.
METHODS


Seventeen participants (15.7 years ± 2.9 years), with conditions that impacted on their musculoskeletal health, completed 20 weeks of side-alternating VT for 9 min/session, 4 times/week at 20 Hz. Data were collected at baseline and after 20 weeks of intervention. Assessments included whole-body dual-energyX-ray absorptiometry, muscle function (force plate) and 6-min walk test.
RESULTS


Compliance with the prescribed VT training protocol was relatively high overall at 78% and there were no adverse events reported. After 20 weeks intervention, functional assessments showed time taken to perform the chair test was reduced by 15% (P = 0.018), leg balance improved with standard ellipse area decreasing by 88% (P = 0.006) and distance walked in the 6-min walk test improved by 9% (P = 0.002). Participants displayed increased total body mass (1.94 kg; P = 0.018) with increased lean mass (1.20 kg; P = 0.019) but not fat mass (P = 0.19). There was no change in total body bone mineral density (P = 0.44) or bone mineral content (P = 0.07).
CONCLUSIONS


Twenty weeks of side-alternating VT was a feasible protocol that was associated with improvements in physical function and no detrimental effects on lean mass, bone mass or density in children and adolescents with musculoskeletal disorders.",2020,Participants displayed increased total body mass (1.94 kg; P = 0.018) with increased lean mass (1.20 kg; P = 0.019) but not fat mass (P = 0.19).,"['Seventeen participants (15.7\u2009years\u2009±\u20092.9\u2009years), with conditions that impacted on their musculoskeletal health, completed 20\u2009weeks of side-alternating VT for 9 min/session, 4 times/week at 20\u2009Hz', 'children and adolescents with a range of musculoskeletal disorders', 'children and adolescents with musculoskeletal disorders']","['vibration therapy (VT', 'side-alternating vibration therapy']","['lean mass, bone mass or density', 'physical function', 'whole-body dual-energyX-ray absorptiometry, muscle function (force plate) and 6-min walk test', 'lean mass', 'distance walked in the 6-min walk test', 'total body mass', 'time taken to perform the chair test', 'safety, feasibility and efficacy', 'Safety, feasibility and efficacy', 'bone mineral content', 'bone and muscle health', 'total body bone mineral density', 'leg balance']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}]","[{'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0086894', 'cui_str': 'Rajiformes'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",17.0,0.0430062,Participants displayed increased total body mass (1.94 kg; P = 0.018) with increased lean mass (1.20 kg; P = 0.019) but not fat mass (P = 0.19).,"[{'ForeName': 'Renuka M', 'Initials': 'RM', 'LastName': 'Vesey', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Hofman', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'José Gb', 'Initials': 'JG', 'LastName': 'Derraik', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Colle', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Janene B', 'Initials': 'JB', 'LastName': 'Biggs', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Craig F', 'Initials': 'CF', 'LastName': 'Munns', 'Affiliation': ""Endocrinology Department, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.""}, {'ForeName': 'Wayne S', 'Initials': 'WS', 'LastName': 'Cutfield', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Silmara', 'Initials': 'S', 'LastName': 'Gusso', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}]",Journal of paediatrics and child health,['10.1111/jpc.14913']
2842,32436309,The effect of plasma rich platelet graft on post-operative complications in mid-penile hypospadias.,"Hypospadias is one of the most common penile congenital anomalies, which often requires a surgical approach. After the hypospadias is repaired, urethral fistula can occur in around 20% of patients. In this study, we used platelet-rich plasma (PRP) to reduce the urethral fistula and other post-operative complications after hypospadias repair. Only patients with primary mid-penile hypospadias were included study. Patients with forms other than mid-penile hypospadias and cases with previous hypospadias surgery were excluded from the study. A total of 40 hypospadias patients were included in this study. These patients were divided into groups A and B with 20 patients in each group. Hypospadias repair was performed with the Snodgrass TIPU technique on both groups. PRP was used with group A, and PRP was not use with group B. These two groups were compared in terms of early and long-term post-operative complications. Both early and long-term post-operative UCF, urethral stenosis and post-operative infection rates were lower in the group using PRP, group A. PRP has the potential to prevent post-operative complications occurring after hypospadias repair, particularly post-operative infection.",2020,"Both early and long-term post-operative UCF, urethral stenosis and post-operative infection rates were lower in the group using PRP, group A. PRP has the potential to prevent post-operative complications occurring after hypospadias repair, particularly post-operative infection.","['Patients with forms other than mid-penile hypospadias and cases with previous hypospadias surgery', 'Only patients with primary mid-penile hypospadias', '40 hypospadias patients', 'hypospadias repair', 'mid-penile hypospadias']","['PRP', 'plasma rich platelet graft', 'platelet-rich plasma (PRP']",['urethral stenosis and post-operative infection rates'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C1691215', 'cui_str': 'Hypospadias, penile'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0558337', 'cui_str': 'Hypospadias repair'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",40.0,0.0244697,"Both early and long-term post-operative UCF, urethral stenosis and post-operative infection rates were lower in the group using PRP, group A. PRP has the potential to prevent post-operative complications occurring after hypospadias repair, particularly post-operative infection.","[{'ForeName': 'Recep', 'Initials': 'R', 'LastName': 'Eryilmaz', 'Affiliation': 'Department of Urology, Yuzuncu Yil University, School of Medicine, Van, Turkey.'}, {'ForeName': 'Metin', 'Initials': 'M', 'LastName': 'Şimşek', 'Affiliation': 'Department of Pediatric Surgery, Van Education and Research Hospital, Van, Turkey.'}, {'ForeName': 'Rahmi', 'Initials': 'R', 'LastName': 'Aslan', 'Affiliation': 'Department of Urology, Yuzuncu Yil University, School of Medicine, Van, Turkey.'}, {'ForeName': 'Burhan', 'Initials': 'B', 'LastName': 'Beger', 'Affiliation': 'Department of Pediatric Surgery, Yuzuncu Yil University, School of Medicine, Van, Turkey.'}, {'ForeName': 'Kasım', 'Initials': 'K', 'LastName': 'Ertaş', 'Affiliation': 'Department of Urology, Yuzuncu Yil University, School of Medicine, Van, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Taken', 'Affiliation': 'Department of Urology, Yuzuncu Yil University, School of Medicine, Van, Turkey.'}]",Andrologia,['10.1111/and.13652']
2843,32436390,Use of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement: Findings from the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study.,"Background:  Whether passively collected data can substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials is not well known.  Methods:  We linked adults aged ≥65 in the US CoreValve Pivotal High Risk (HiR) and Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients (SURTAVI) Trials to 100% Medicare inpatient claims, 1/1/2003-12/31/2016. Primary (e.g. death and stroke) and secondary trial endpoints, were compared across treatment arms (e.g. TAVR vs. SAVR) using trial-adjudicated outcomes versus outcomes derived from claims at 1-year (HiR) or 2-years (SURTAVI).  Results:  Among 600 linked CoreValve HiR participants (linkage rate 80.0%), the rate of the trial's primary endpoint of all-cause mortality occurred in 13.7% of patients receiving TAVR and 16.4% of patients receiving SAVR at 1-year using both trial data (HR 0.84, 95% CI 0.65-1.09; p= 0.33) and claims data (HR 0.86, 95% CI 0.66-1.11; p = 0.34; interaction p-value = 0.80). Noninferiority of TAVR relative to SAVR was seen using both trial and claims-based outcomes (p noninferiority  < 0.001 for both). Among 1005 linked SURTAVI trial participants (linkage rate 60.5%), the trial's primary endpoint was 12.9% for TAVR and 13.1% for SAVR using trial data (HR 1.08, 95% CI 0.79-1.48, p = 0.90), and 11.3% for TAVR and 12.5% for SAVR patients using claims data (HR 1.02, 95% CI 0.73-1.41, p = 0.58; interaction p-value = 0.89). TAVR was noninferior to SAVR when compared using both trial and claims (p non-inferiority  < 0.001 for both). Rates of procedural secondary outcomes (e.g. aortic valve reintervention, pacemaker rates) were more closely concordant between trial and claims data than non-procedural outcomes (e.g., stroke, bleeding, cardiogenic shock).  Conclusions:  In the CoreValve HiR and SURTAVI trials, ascertainment of trial primary endpoints using claims reproduced both the magnitude and direction of treatment effect compared with adjudicated event data, but non-fatal and non-procedural secondary outcomes were not as well reproduced. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be valid and feasible for all-cause mortality and certain procedural outcomes, but may be less suitable for other endpoints.",2020,TAVR was noninferior to SAVR when compared using both trial and claims (p non-inferiority  < 0.001 for both).,"['adults aged ≥65 in the US CoreValve Pivotal High Risk (HiR) and Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients (SURTAVI) Trials to 100% Medicare inpatient claims, 1/1/2003-12/31/2016']","['TAVR', 'Transcatheter Aortic Valve Replacement']","['cause mortality', 'aortic valve reintervention, pacemaker rates', 'claims at 1-year (HiR) or 2-years (SURTAVI', 'stroke, bleeding, cardiogenic shock']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}]",1005.0,0.276108,TAVR was noninferior to SAVR when compared using both trial and claims (p non-inferiority  < 0.001 for both).,"[{'ForeName': 'Jordan B', 'Initials': 'JB', 'LastName': 'Strom', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Kamil F', 'Initials': 'KF', 'LastName': 'Faridi', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Neel M', 'Initials': 'NM', 'LastName': 'Butala', 'Affiliation': 'Harvard Medical School, Boston, MA; Division of Cardiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Yuansong', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Tamez', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Valsdottir', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'J Matthew', 'Initials': 'JM', 'LastName': 'Brennan', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Changyu', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA; Baim Institute for Clinical Research, Boston, MA.'}, {'ForeName': 'Dhruv S', 'Initials': 'DS', 'LastName': 'Kazi', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Yeh', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA; Baim Institute for Clinical Research, Boston, MABaim Institute for Clinical Research, Boston, MA.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.046159']
2844,32436277,"Stress-reducing effects of a brief mindfulness intervention in palliative care: Results from a randomised, crossover study.","OBJECTIVE


Mindfulness-based interventions are a widely used and highly accepted adjunct treatment in oncology. Due to a paucity of research in advanced cancer and other terminal illnesses, we aimed to evaluate the stress-reducing effects of a brief, standardised mindfulness intervention for use in palliative care.
METHODS


This study was a randomised, crossover trial where patients participated in both a single mindfulness intervention and a resting state control condition. The order of the conditions was randomised. Study outcomes encompassed self-report data on stress and well-being and measures of heart rate variability. All outcome data were measured at four times per day.
RESULTS


Forty-two patients participated in this study. We found significantly stronger reductions in self-rated stress and mean heart rate as well as an increase in heart rate variability after the mindfulness intervention. Psychophysiological effects were strongest in the immediate pre- to post-intervention comparison, while the effect on subjective stress persisted after 20 to 40 min. No significant differences were found for self-rated well-being.
CONCLUSIONS


Despite the rather small magnitude of effects, the brief mindfulness intervention showed to be effective and accepted by patients in very advanced stages of a disease and could be offered by trained healthcare professionals in palliative care.",2020,We found significantly stronger reductions in self-rated stress and mean heart rate as well as an increase in heart rate variability after the mindfulness intervention.,"['patients participated in both a single mindfulness intervention and a resting state control condition', 'palliative care', 'Forty-two patients participated in this study']",['brief mindfulness intervention'],"['self-rated well-being', 'Psychophysiological effects', 'subjective stress', 'heart rate variability', 'self-report data on stress and well-being and measures of heart rate variability', 'self-rated stress and mean heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",42.0,0.0486242,We found significantly stronger reductions in self-rated stress and mean heart rate as well as an increase in heart rate variability after the mindfulness intervention.,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Warth', 'Affiliation': 'Institute of Medical Psychology, Center for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Koehler', 'Affiliation': 'Institute of Medical Psychology, Center for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Aguilar-Raab', 'Affiliation': 'Institute of Medical Psychology, Center for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Hubert J', 'Initials': 'HJ', 'LastName': 'Bardenheuer', 'Affiliation': 'Center of Pain Therapy and Palliative Care Medicine, Department of Anesthesiology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Ditzen', 'Affiliation': 'Institute of Medical Psychology, Center for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kessler', 'Affiliation': 'Center of Pain Therapy and Palliative Care Medicine, Department of Anesthesiology, University Hospital Heidelberg, Heidelberg, Germany.'}]",European journal of cancer care,['10.1111/ecc.13249']
2845,32436633,Five weeks of heat training increases hemoglobin mass in elite cyclists.,"NEW FINDINGS


What is the central question of this study? We set out to test the hypothesis that hemoglobin mass and red blood cell volume would become increased in elite cyclists training in a hot environment compared to control group training in normal temperature. What is the main finding and its importance? We demonstrate that five weeks of heat training increases hemoglobin mass in elite cyclists. At the same time we reveal small to intermediate effect sizes for exercise parameters favoring heat training.
ABSTRACT


In this study we tested the hypothesis that performing one hour of regular light exercise in a heat chamber (HEAT; 37.8 ± 0.5°C; 65.4 ± 1.8% humidity) five times·week -1  for a total of five weeks increases hemoglobin mass (Hb mass  ) and exercise performance in elite cyclists (V̇O 2max   = 76.2 ± 7.6 mL·min -1  ·kg -1  ). 23 male volunteers were assigned into HEAT (n = 11) or CON (n = 12; 15.5 ± 0.1°C; 25.1 ± 0.0% humidity) training groups. Hb mass  was determined before and after the intervention period in conjugation with and an extensive exercise test protocol (conducted in 16-19°C). HEAT increased (p < 0.05) Hb mass  by 42 g from 893 ± 78 to 935 ± 108 g whereas Hb mass  remained unchanged (+ 6 g) in CON. Furthermore, statistical analysis revealed a time-group interaction (p < 0.05). The greater increase in Hb mass  in HEAT did however not manifest in a greater increase in V̇O 2max  (225 ± 274 mL·min -1  in HEAT and 161 ± 202 mL·min -1  in CON). While HEAT reduced (p < 0.05) lactate levels during some of the submaximal exercise tests, there were no statistical difference between other performance parameters. There were however small to intermediate effect sizes favoring HEAT for lactate threshold power output (2.8 ± 3.9 vs. -0.4 ± 5.1% change, ES = 0.34), gross economy in the fatigued state (0.19 ± 0.42 vs. -0.12 ± 0.49%-point change, ES = 0.52) and 15-min mean power (6.9 ± 8.4 vs. 3.4 ± 5.1% increase, ES = 0.22). This study demonstrates an increase in Hb mass  and small to intermediate effect sizes on exercise variables in elite cyclists following a five-week heat training intervention. This article is protected by copyright. All rights reserved.",2020,HEAT increased (p < 0.05),"['202', '274', 'elite cyclists (V̇O 2max  \xa0=\xa076.2\xa0±\xa07.6\xa0mL·min -1  ·kg -1  ', '23 male volunteers', 'elite cyclists following a five-week heat training intervention', 'g from 893\xa0±\xa078 to 935\xa0±\xa0108', 'elite cyclists']","['extensive exercise test protocol', 'HEAT', 'regular light exercise', 'heat training', 'CON']","['lactate levels', 'V̇O 2max  (225\xa0±', 'hemoglobin mass (Hb mass  ) and exercise performance', 'hemoglobin mass']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",23.0,0.01331,HEAT increased (p < 0.05),"[{'ForeName': 'Bent R', 'Initials': 'BR', 'LastName': 'Rønnestad', 'Affiliation': 'Innland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Hamarsland', 'Affiliation': 'Innland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Joar', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': 'Innland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Espen', 'Initials': 'E', 'LastName': 'Holen', 'Affiliation': 'Innland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Montero', 'Affiliation': 'Faculty of Kinesiology, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Jon Elling', 'Initials': 'JE', 'LastName': 'Whist', 'Affiliation': 'Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Lundby', 'Affiliation': 'Innland University of Applied Sciences, Lillehammer, Norway.'}]",Experimental physiology,['10.1113/EP088544']
2846,31505002,Perceptions of uncertainties about carrier results identified by exome sequencing in a randomized controlled trial.,"How individuals perceive uncertainties in sequencing results may affect their clinical utility. The purpose of this study was to explore perceptions of uncertainties in carrier results and how they relate to psychological well-being and health behavior. Post-reproductive adults (N = 462) were randomized to receive carrier results from sequencing through either a web platform or a genetic counselor. On average, participants received two results. Group differences in affective, evaluative, and clinical uncertainties were assessed from baseline to 1 and 6 months; associations with test-specific distress and communication of results were assessed at 6 months. Reductions in affective uncertainty (∆x̅ = 0.78, 95% CI: 0.53, 1.02) and evaluative uncertainty (∆x̅ = 0.69, 95% CI: 0.51, 0.87) followed receipt of results regardless of randomization arm at 1 month. Participants in the web platform arm reported greater clinical uncertainty than those in the genetic counselor arm at 1 and 6 months; this was corroborated by the 1,230 questions asked of the genetic counselor and residual questions reported by those randomized to the web platform. Evaluative uncertainty was associated with a lower likelihood of communicating results to health care providers. Clinical uncertainty was associated with a lower likelihood of communicating results to children. Learning one's carrier results may reduce perceptions of uncertainties, though web-based return may lead to less reduction in clinical uncertainty in the short term. These findings warrant reinforcement of clinical implications to minimize residual questions and promote appropriate health behavior (communicating results to at-risk relatives in the case of carrier results), especially when testing alternative delivery models.",2020,"Participants in the web platform arm reported greater clinical uncertainty than those in the genetic counselor arm at 1 and 6 months; this was corroborated by the 1,230 questions asked of the genetic counselor and residual questions reported by those randomized to the web platform.",['Post-reproductive adults (N = 462'],[],"['clinical uncertainty', 'affective, evaluative, and clinical uncertainties', 'evaluative uncertainty']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}]",1230.0,0.0506405,"Participants in the web platform arm reported greater clinical uncertainty than those in the genetic counselor arm at 1 and 6 months; this was corroborated by the 1,230 questions asked of the genetic counselor and residual questions reported by those randomized to the web platform.","[{'ForeName': 'Kendall L', 'Initials': 'KL', 'LastName': 'Umstead', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Paul K J', 'Initials': 'PKJ', 'LastName': 'Han', 'Affiliation': 'Center for Outcomes Research and Evaluation, Maine Medical Center Research Institute, Scarborough, ME, USA.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Lewis', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Ilana M', 'Initials': 'IM', 'LastName': 'Miller', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Hepler', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Lydia J', 'Initials': 'LJ', 'LastName': 'Thompson', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Tyra G', 'Initials': 'TG', 'LastName': 'Wolfsberg', 'Affiliation': 'Computational and Statistical Genomics Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Anh-Dao', 'Initials': 'AD', 'LastName': 'Nguyen', 'Affiliation': 'Computational and Statistical Genomics Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Fredriksen', 'Affiliation': 'Computational and Statistical Genomics Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Gibney', 'Affiliation': 'Computational and Statistical Genomics Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Turbitt', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Leslie G', 'Initials': 'LG', 'LastName': 'Biesecker', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}, {'ForeName': 'Barbara B', 'Initials': 'BB', 'LastName': 'Biesecker', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, MD, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz111']
2847,31504554,Nocturnal Gamma-Hydroxybutyrate Reduces Cortisol-Awakening Response and Morning Kynurenine Pathway Metabolites in Healthy Volunteers.,"BACKGROUND


Gamma-hydroxybutyrate (GHB; or sodium oxybate) is an endogenous GHB-/gamma-aminobutyric acid B receptor agonist. It is approved for application in narcolepsy and has been proposed for the potential treatment of Alzheimer's disease, Parkinson's disease, fibromyalgia, and depression, all of which involve neuro-immunological processes. Tryptophan catabolites (TRYCATs), the cortisol-awakening response (CAR), and brain-derived neurotrophic factor (BDNF) have been suggested as peripheral biomarkers of neuropsychiatric disorders. GHB has been shown to induce a delayed reduction of T helper and natural killer cell counts and alter basal cortisol levels, but GHB's effects on TRYCATs, CAR, and BDNF are unknown.
METHODS


Therefore, TRYCAT and BDNF serum levels, as well as CAR and the affective state (Positive and Negative Affect Schedule [PANAS]) were measured in the morning after a single nocturnal dose of GHB (50 mg/kg body weight) in 20 healthy male volunteers in a placebo-controlled, balanced, randomized, double-blind, cross-over design.
RESULTS


In the morning after nocturnal GHB administration, the TRYCATs indolelactic acid, kynurenine, kynurenic acid, 3-hydroxykynurenine, and quinolinic acid; the 3-hydroxykynurenine to kynurenic acid ratio; and the CAR were significantly reduced (P < 0.05-0.001, Benjamini-Hochberg corrected). The quinolinic acid to kynurenic acid ratio was reduced by trend. Serotonin, tryptophan, and BDNF levels, as well as PANAS scores in the morning, remained unchanged after a nocturnal GHB challenge.
CONCLUSIONS


GHB has post-acute effects on peripheral biomarkers of neuropsychiatric disorders, which might be a model to explain some of its therapeutic effects in disorders involving neuro-immunological pathologies. This study was registered at ClinicalTrials.gov as NCT02342366.",2019,"Serotonin, tryptophan, and BDNF levels as well as PANAS scores in the morning remained unchanged after nocturnal GHB challenge.
","['20 healthy male volunteers in a', 'healthy volunteers']","['GHB', 'Nocturnal gamma-hydroxybutyrate', 'Gamma-hydroxybutyrate (GHB; or sodium oxybate', 'placebo']","['quinolinic acid to kynurenic acid ratio', 'cortisol awakening response', 'TRYCAT and BDNF serum levels', 'Serotonin, tryptophan, and BDNF levels', 'Tryptophan catabolites (TRYCATs), the cortisol awakening response (CAR), and brain derived neurotrophic factor (BDNF']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0037537', 'cui_str': 'Sodium Oxybate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0072879', 'cui_str': '2,3-Pyridinedicarboxylic acid'}, {'cui': 'C0022816', 'cui_str': '2-Quinolinecarboxylic acid, 4-hydroxy-'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}]",20.0,0.175661,"Serotonin, tryptophan, and BDNF levels as well as PANAS scores in the morning remained unchanged after nocturnal GHB challenge.
","[{'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Dornbierer', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boxler', 'Affiliation': 'Department of Forensic Pharmacology and Toxicology, Zurich Institute of Forensic Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Voegel', 'Affiliation': 'Center for Forensic Hair Analytics, Zurich Institute of Forensic Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Stucky', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Steuer', 'Affiliation': 'Department of Forensic Pharmacology and Toxicology, Zurich Institute of Forensic Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Binz', 'Affiliation': 'Center for Forensic Hair Analytics, Zurich Institute of Forensic Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Baumgartner', 'Affiliation': 'Center for Forensic Hair Analytics, Zurich Institute of Forensic Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Baur', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'B B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Forensic Pharmacology and Toxicology, Zurich Institute of Forensic Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Landolt', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'O G', 'Initials': 'OG', 'LastName': 'Bosch', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyz047']
2848,31506877,Effects of lung protective ventilation on postoperative respiratory parameters in patients undergoing robot-assisted radical prostatectomy.,"To investigate the effects of lung protective ventilation (LPV) compared to conventional ventilation (CV) on postoperative respiratory parameters in patients undergoing robot-assisted radical prostatectomy (RARP). In total, 24 patients undergoing RARP were randomized to two groups receiving either LPV with a tidal volume of 6 ml/IBW with a positive end-expiratory pressure (PEEP) of 10 cm H 2 O (intervention) or CV with a tidal volume of 10 ml/IBW with a PEEP of 4 cmH 2 O (control). Primary endpoint was PaO 2  2 h postoperatively after 10 min of spontaneous respiration of atmospheric air. Forced expiratory volume during the first second (FEV 1 ), forced vital capacity (FVC), diffusion capacity (DLCO), and plasma interleukin-6 (IL-6) was measured before and after the surgery. Pulmonary complications were registered within the first year after surgery. All patients completed the study. No difference was found in PaO 2  between LPV and CV. However, 4 patients in the LPV group had a decrease in saturation below 90% during the 10 min of spontaneous respiration of atmospheric air compared to none in the CV group. FEV 1 , FVC, and DLCO were similar when comparing the two groups at all timepoints and no patients in either of the groups had pulmonary complications during the first postoperative year. IL-6 levels increased during surgery in both groups, but were not significantly different between the two groups. We found no evidence of lung protective effects of LPV compared to CV estimated by pulmonary function tests, IL-6 levels and postoperative complications in patients undergoing RARP. Surprisingly, only patients in the LPV group and none in the CV group had a decline in saturation below 90% during the 10 min of breathing atmospheric air.",2020,"We found no evidence of lung protective effects of LPV compared to CV estimated by pulmonary function tests, IL-6 levels and postoperative complications in patients undergoing RARP.","['patients undergoing robot-assisted radical prostatectomy', 'patients undergoing RARP', '24 patients undergoing RARP', 'patients undergoing robot-assisted radical prostatectomy (RARP']","['conventional ventilation (CV', 'LPV with a tidal volume of 6\xa0ml/IBW with a positive end-expiratory pressure (PEEP) of 10\xa0cm H 2 O (intervention) or CV with a tidal volume of 10\xa0ml/IBW with a PEEP of 4 cmH 2 O (control', 'LPV', 'lung protective ventilation', 'lung protective ventilation (LPV']","['pulmonary complications', 'FEV 1 , FVC, and DLCO', 'PaO 2  2\xa0h postoperatively after 10\xa0min of spontaneous respiration of atmospheric air', 'Forced expiratory volume during the first second (FEV 1 ), forced vital capacity (FVC), diffusion capacity (DLCO), and plasma interleukin-6 (IL-6', 'pulmonary function tests, IL-6 levels and postoperative complications', 'saturation', 'IL-6 levels', 'postoperative respiratory parameters', 'Pulmonary complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}]","[{'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration (finding)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0554066,"We found no evidence of lung protective effects of LPV compared to CV estimated by pulmonary function tests, IL-6 levels and postoperative complications in patients undergoing RARP.","[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Mølsted', 'Affiliation': 'Department of Urology, Regional Hospital of West Jutland, Holstebro, Denmark. mette_molsted@hotmail.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ekeløf', 'Affiliation': 'Department of Anaestesiology, Regional Hospital of West Jutland, Holstebro, Denmark.'}, {'ForeName': 'Jesper Nørgaard', 'Initials': 'JN', 'LastName': 'Bech', 'Affiliation': 'University Clinic in Nephrology and Hypertension, Regional Hospital of West Jutland, Aarhus University, Holstebro, Denmark.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Wessels', 'Affiliation': 'Department of Pulmonary Medicine, Regional Hospital of West Jutland, Holstebro, Denmark.'}, {'ForeName': 'Jørgen Bjerggaard', 'Initials': 'JB', 'LastName': 'Jensen', 'Affiliation': 'Department of Urology, Regional Hospital of West Jutland, Holstebro, Denmark.'}]",Journal of robotic surgery,['10.1007/s11701-019-01016-y']
2849,32436287,Clinical and trichoscopic evaluation of trichloroacetic acid 35% vs phenol 88% peels in treatment of alopecia areata.,"BACKGROUND


Among alopecia areata (AA) treatments, contact irritants (anthralin) and topical immunotherapies (diphenylcyclopropenone) have been successfully used. Chemoexfoliation can potentially be utilized, acting as irritants and consecutively immunomodulators. Peels via therapeutic wounding provoke growth factors and cytokines that may induce hair regrowth.
AIM


To evaluate and compare trichloroacetic acid (TCA) 35% and phenol 88% peels effectiveness and tolerability in patchy AA.
PATIENTS/METHODS


This comparative, randomized, double-blind study included 20 patients with multifocal patchy AA. In each patient, 2 patches were selected and randomized into group I (20 patches: TCA 35%) and group II (20 patches: phenol 88%). A session was performed every 3 weeks for 9 weeks. Response was assessed by two blinded observers as regards percentage of clinical improvement, severity of alopecia tool (SALT), and trichoscopic scaled scores for dystrophic and terminal hairs, respectively. Patients were scheduled for follow-up visits over 6 months past treatment cessation.
RESULTS


A total of 19 patients completed the study and showed significant reduction in SALT score. TCA- and phenol-treated patches demonstrated significant improvement in the percentage of clinical improvement, trichoscopic scale of dystrophic and terminal hairs. However, TCA was superior to phenol as it showed significant more reduction in trichoscopic score of dystrophic hairs and significant higher increase in terminal hairs. Phenol yielded significant higher discomfort than TCA. No relapse was detected.
CONCLUSIONS


Trichloroacetic acid 35% and phenol 88% peels can be considered effective therapeutic modalities for patchy AA. TCA 35% represents a treatment of choice in terms of the efficacy and tolerability.",2020,"TCA- and phenol-treated patches demonstrated significant improvement in the percentage of clinical improvement, trichoscopic scale of dystrophic and terminal hairs.",['20 patients with multifocal patchy AA'],"['topical immunotherapies (diphenylcyclopropenone', 'trichloroacetic acid (TCA', 'TCA', 'trichloroacetic acid 35% vs phenol 88% peels', 'Trichloroacetic acid 35% and phenol 88% peels']","['alopecia areata', 'clinical improvement, severity of alopecia tool (SALT), and trichoscopic scaled scores for dystrophic and terminal hairs, respectively', 'efficacy and tolerability', 'SALT score', 'percentage of clinical improvement, trichoscopic scale of dystrophic and terminal hairs', 'trichoscopic score of dystrophic hairs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0205413', 'cui_str': 'Patchy'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0058379', 'cui_str': 'diphenylcyclopropenone'}, {'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}, {'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}]","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221960', 'cui_str': 'Structure of terminal hair'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0544849', 'cui_str': 'Hair dystrophy'}]",20.0,0.0492092,"TCA- and phenol-treated patches demonstrated significant improvement in the percentage of clinical improvement, trichoscopic scale of dystrophic and terminal hairs.","[{'ForeName': 'Doaa', 'Initials': 'D', 'LastName': 'Mahgoub', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Riham', 'Initials': 'R', 'LastName': 'Mohye Eldeen', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Saadi', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Solwan', 'Initials': 'S', 'LastName': 'El-Samanoudy', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13465']
2850,32436318,"Decreasing risk of psychosis by sulforaphane study protocol for a randomized, double-blind, placebo-controlled, clinical multi-centre trial.","AIM


A growing number of studies suggest a role of neuroinflammation and oxidative stress in the pathophysiology of psychosis. Sulforaphane (SFN), a natural compound extracted from cruciferous vegetables, has shown anti-inflammatory and anti-oxidative effects which imply a potential effect on decreasing the risk of psychosis. However, there is no study testing the efficacy of SFN for this purpose. It's necessary to evaluate its efficacy on individuals at clinical high risk (CHR) for psychosis.
METHODS


This is a randomized, double-blind, placebo-controlled, multi-centre trial. A total of 300 CHR subjects will be identified in the course of face-to-face interviews using the Structured Interview for Prodromal Syndromes. All participants will be randomly allocated to SFN group (n = 150) or placebo group (n = 150). The study duration includes an intervention for 52 consecutive weeks, and additional 1-year follow-up.
RESULTS


The primary outcome is 2-year conversion rate of psychosis. Secondary outcomes include 1-year conversion rate of psychosis, the severity and duration of prodromal symptoms, predictive risk of psychosis conversion, neurocognitive functioning and peripheral blood biomarkers of inflammation, oxidative stress and metabolism. Safety monitoring will be performed using scales for side effect, serious adverse events recording, and laboratory tests.
CONCLUSION


This trial is expected to clarify the efficacy of SFN in improving prodromal symptoms, and its role in decreasing the risk and conversion rate of psychosis among CHR subjects. The results will also provide solid evidence about the efficacy and safety of SFN in CHR population. Potential challenges and their solutions in performing the present trial are discussed.",2020,A total of 300 CHR subjects will be identified in the course of face-to-face interviews using the Structured Interview for Prodromal Syndromes.,"['CHR subjects', 'individuals at clinical high risk (CHR) for psychosis', '300 CHR subjects']","['SFN', 'Sulforaphane (SFN', 'placebo']","['2-year conversion rate of psychosis', '1-year conversion rate of psychosis, the severity and duration of prodromal symptoms, predictive risk of psychosis conversion, neurocognitive functioning and peripheral blood biomarkers of inflammation, oxidative stress and metabolism']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0163159', 'cui_str': 'sulforafan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3494358', 'cui_str': 'Prodromal Syndromes'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",300.0,0.417375,A total of 300 CHR subjects will be identified in the course of face-to-face interviews using the Structured Interview for Prodromal Syndromes.,"[{'ForeName': 'Zhixing', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China.'}, {'ForeName': 'Tianhong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shenzhen R&D Center, Shenzhen Fushan Biotech Co., Ltd., Shenzhen, PR China.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, New York, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai, PR China.'}]",Early intervention in psychiatry,['10.1111/eip.12988']
2851,32436465,Assessment of dysphonia: cepstral analysis versus conventional acoustic analysis.,"Objective:  In this study, we aimed to determine the extent to which smoothed cepstral peak prominence (CPPS) can replace or complement the conventional acoustic measures of jitter, shimmer, and harmonic-to-noise ratio in the assessment of various types of dysphonia. Methodology:  A total of 60 males and 80 females were divided into two groups: dysphonic group and control group (30 males and 40 females in each group). The voice samples in the form of sustained vowel /a/ phonation and continuous speech were recorded and assessed using auditory perceptual analysis, acoustic analysis, and cepstral analysis. Results:  Jitter was found to have the best predictive ability during sustained phonation, whereas CPPS was found to have the best predictive ability during continuous speech. Conclusion:  Cepstral analysis is as reliable as the conventional acoustic analysis in the diagnosis of dysphonia and to detect its severity. However, CPPS cannot replace conventional acoustic measures.",2020,"Jitter was found to have the best predictive ability during sustained phonation, whereas CPPS was found to have the best predictive ability during continuous speech.","['60 males and 80 females', '30 males and 40 females in each group']","['CPPS', 'dysphonic group and control group', 'conventional acoustic analysis']",[],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],60.0,0.0208047,"Jitter was found to have the best predictive ability during sustained phonation, whereas CPPS was found to have the best predictive ability during continuous speech.","[{'ForeName': 'Elham Moamen', 'Initials': 'EM', 'LastName': 'Hassan', 'Affiliation': 'Faculty of Medicine, Department of Otolaryngology, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Aisha Fawzy', 'Initials': 'AF', 'LastName': 'Abdel Hady', 'Affiliation': 'Faculty of Medicine, Department of Otolaryngology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sahar Saad', 'Initials': 'SS', 'LastName': 'Shohdi', 'Affiliation': 'Faculty of Medicine, Department of Otolaryngology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hossam Mohammed', 'Initials': 'HM', 'LastName': 'Eldessouky', 'Affiliation': 'Faculty of Medicine, Department of Otolaryngology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohammed Hussein Badrel', 'Initials': 'MHB', 'LastName': 'Din', 'Affiliation': 'Faculty of Medicine, Department of Otolaryngology, Suez Canal University, Ismailia, Egypt.'}]","Logopedics, phoniatrics, vocology",['10.1080/14015439.2020.1767202']
2852,30541754,FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy.,"The U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab and pembrolizumab in April and May 2017, respectively, for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. These approvals were based on efficacy and safety data demonstrated in the two single-arm trials, IMvigor210 (atezolizumab) and KEYNOTE-052 (pembrolizumab). The primary endpoint, confirmed objective response rate, was 23.5% (95% confidence interval [CI]: 16.2%-32.2%) in patients receiving atezolizumab and 28.6% (95% CI: 24.1%-33.5%) in patients receiving pembrolizumab. The median duration of response was not reached in either study and responses were seen regardless of PD-L1 status. The safety profiles of both drugs were generally consistent with approved agents targeting PD-1/PD-L1. Two ongoing trials (IMvigor130 and KEYNOTE-361) are verifying benefit of these drugs. Based on concerning preliminary reports from these trials, FDA revised the indications for both agents in cisplatin-ineligible patients. Both drugs are now indicated for patients not eligible for any platinum-containing chemotherapy or not eligible for cisplatin-containing chemotherapy and whose tumors/infiltrating immune cells express a high level of PD-L1. The indications for atezolizumab and pembrolizumab in patients who have received prior platinum-based therapy have not been changed. This article summarizes the FDA thought process and data supporting the accelerated approval of both agents and the subsequent revision of the indications. IMPLICATIONS FOR PRACTICE: The accelerated approvals of atezolizumab and pembrolizumab for cisplatin-ineligible patients with advanced urothelial carcinoma represent the first approved therapies for this patient population. These approvals were based on single-arm trials demonstrating reasonable objective response rates and favorable durations of response with an acceptable toxicity profile compared with available non-cisplatin-containing chemotherapy regimens. However, based on concerning preliminary reports from two ongoing phase III trials, the FDA revised the indication for both agents in cisplatin-ineligible patients. Both are now indicated either for patients not eligible for any platinum-containing chemotherapy or not eligible for cisplatin-containing chemotherapy and whose tumors have high expression of PD-L1.",2019,"The primary endpoint, confirmed objective response rate, was 23.5% (95% confidence interval [CI]: 16.2%-32.2%) in patients receiving atezolizumab and 28.6% (95% CI: 24.1%-33.5%) in patients receiving pembrolizumab.","['patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy', 'ineligible patients with advanced urothelial carcinoma', 'patients who have received prior platinum-based therapy have not been changed', 'Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy', 'patients not eligible for any platinum-containing chemotherapy or not eligible for']","['atezolizumab', 'IMvigor210 (atezolizumab) and KEYNOTE-052 (pembrolizumab', 'Atezolizumab or Pembrolizumab', 'cisplatin', 'atezolizumab and pembrolizumab', 'cisplatin-containing chemotherapy']","['objective response rate', 'median duration of response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0458075,"The primary endpoint, confirmed objective response rate, was 23.5% (95% confidence interval [CI]: 16.2%-32.2%) in patients receiving atezolizumab and 28.6% (95% CI: 24.1%-33.5%) in patients receiving pembrolizumab.","[{'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Suzman', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA daniel.suzman@fda.hhs.gov.'}, {'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Yang-Min', 'Initials': 'YM', 'LastName': 'Ning', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'V Ellen', 'Initials': 'VE', 'LastName': 'Maher', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Fernandes', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Karuri', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Sridhara', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Schroeder', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'McKee', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}]",The oncologist,['10.1634/theoncologist.2018-0084']
2853,31246555,Effects of dynamic arm and leg exercise on muscle sympathetic nerve activity and vascular conductance in the inactive leg.,"The influence of muscle sympathetic nerve activity (MSNA) responses on local vascular conductance during exercise are not well established. Variations in exercise mode and active muscle mass can produce divergent MSNA responses. Therefore, we sought to examine the effects of small- versus large-muscle mass dynamic exercise on vascular conductance and MSNA responses in the inactive limb. Thirty-five participants completed two study visits in a randomized order. During  visit 1 , superficial femoral artery (SFA) blood flow (Doppler ultrasound) was assessed at rest and during steady-state rhythmic handgrip (RHG; 1:1 duty cycle, 40% maximal voluntary contraction), one-leg cycling (17 ± 3% peak power output), and concurrent exercise at the same intensities. During  visit 2 , MSNA (contralateral fibular nerve microneurography) was acquired successfully in 12/35 participants during the same exercise modes. SFA blood flow increased during RHG ( P  < 0.0001) and concurrent exercise ( P  = 0.03) but not cycling ( P  = 0.91). SFA vascular conductance was unchanged during RHG ( P  = 0.88) but reduced similarly during concurrent and cycling exercise (both  P  < 0.003). RHG increased MSNA burst frequency ( P  = 0.04) without altering burst amplitude ( P  = 0.69) or total MSNA ( P  = 0.26). In contrast, cycling and concurrent exercise had no effects on MSNA burst frequency (both  P  ≥ 0.10) but increased burst amplitude (both  P  ≤ 0.001) and total MSNA (both  P  ≤ 0.007). Across all exercise modes, the changes in MSNA burst amplitude and SFA vascular conductance were correlated negatively ( r  = -0.43,  P  = 0.02). In summary, the functional vascular consequences of alterations in sympathetic outflow to skeletal muscle are most closely associated with changes in MSNA burst amplitude, but not frequency, during low-intensity dynamic exercise. NEW & NOTEWORTHY  Low-intensity small- versus large-muscle mass exercise can elicit divergent effects on muscle sympathetic nerve activity (MSNA). We examined the relationships between changes in MSNA (burst frequency and amplitude) and superficial femoral artery (SFA) vascular conductance during rhythmic handgrip, one-leg cycling, and concurrent exercise in the inactive leg. Only changes in MSNA burst amplitude were inversely associated with SFA vascular conductance responses. This result highlights the functional importance of measuring MSNA burst amplitude during exercise.",2019,SFA blood flow increased during RHG ( P <0.0001) and concurrent exercise ( P =0.03) but not cycling ( P =0.91).,['Thirty-five participants completed two study visits in a randomized order'],"['dynamic arm and leg exercise', 'small vs. large muscle mass dynamic exercise', 'muscle sympathetic nerve activity (MSNA']","['SFA blood flow', 'burst amplitude (Both,  P ≤0.001) and total MSNA', 'total MSNA', 'vascular conductance and MSNA responses', 'changes in MSNA burst amplitude and SFA vascular conductance', 'RHG increased MSNA burst frequency', 'MSNA burst frequency', 'muscle sympathetic nerve activity and vascular conductance', 'SFA vascular conductance', 'superficial femoral artery (SFA) blood flow (Doppler ultrasound']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0454361', 'cui_str': 'Lower limb exercises (regime/therapy)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery (body structure)'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}]",35.0,0.0536675,SFA blood flow increased during RHG ( P <0.0001) and concurrent exercise ( P =0.03) but not cycling ( P =0.91).,"[{'ForeName': 'Connor J', 'Initials': 'CJ', 'LastName': 'Doherty', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Trevor J', 'Initials': 'TJ', 'LastName': 'King', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Anthony V', 'Initials': 'AV', 'LastName': 'Incognito', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Jordan B', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Shepherd', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Cacoilo', 'Affiliation': 'Department of Kinesiology, University of Guelph-Humber, Toronto, Ontario, Canada.'}, {'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Slysz', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Jamie F', 'Initials': 'JF', 'LastName': 'Burr', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Millar', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00997.2018']
2854,32436453,Enhancing employee wellness: Translating an effective community behavioral weight-loss treatment to the worksite.,"BACKGROUND


As rates of obesity continue to rise in the USA, there is a need for effective treatments for excess adiposity. Behavioral weight-loss interventions can produce clinically meaningful weight reduction through life-style modifications. However, few studies have evaluated the effectiveness of high-intensity behavioral weight-loss interventions at worksites.
AIM


The present research investigated the effectiveness of a previously validated behavioral weight-loss intervention in a Hawai'i worksite.
METHODS


Thirty-six participants were recruited from the employee population of a local employer. Participants received six months of group behavioral weight-loss treatment from trained providers. Anthropomorphic, physiological, psychological, and behavioral assessments were collected pre and post treatment. Select physiological and behavioral assessments were collected every four sessions.
RESULTS


Sixty-one percent of participants adhered to treatment, and 78% of participants completed treatment. From pre to post treatment, results found that participants achieved clinically significant improvements in weight, body mass index (BMI), and waist circumference, with accompanying physiological, psychological, and behavioral improvements ( F (12, 2)=101.379,  p =0.010, partial η 2 =0.998). Analyses revealed that participants also achieved significant changes in weight, BMI, and waist circumference across time points, as well as improvements in specific eating habits.
CONCLUSIONS


The present study demonstrated the efficacy of a worksite behavioral weight-loss program. The present intervention produced clinically significant weight losses for a large proportion of participants, accompanied by significant improvements in physiological, behavioral, and psychological outcomes. This research is promising for the ongoing implementation of behavioral weight-loss approaches.",2020,"The present intervention produced clinically significant weight losses for a large proportion of participants, accompanied by significant improvements in physiological, behavioral, and psychological outcomes.",['Thirty-six participants were recruited from the employee population of a local employer'],"['behavioral weight-loss intervention', 'worksite behavioral weight-loss program', 'Behavioral weight-loss interventions']","['Anthropomorphic, physiological, psychological, and behavioral assessments', 'weight, body mass index (BMI), and waist circumference, with accompanying physiological, psychological, and behavioral improvements', 'physiological, behavioral, and psychological outcomes', 'weight losses', 'weight, BMI, and waist circumference across time points, as well as improvements in specific eating habits']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1274022', 'cui_str': 'Employer'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",36.0,0.0290067,"The present intervention produced clinically significant weight losses for a large proportion of participants, accompanied by significant improvements in physiological, behavioral, and psychological outcomes.","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Murakami', 'Affiliation': 'VA Pacific Islands Healthcare System, USA.'}, {'ForeName': 'Brooke L', 'Initials': 'BL', 'LastName': 'Bennett', 'Affiliation': ""Department of Psychology, University of Hawai'i at Mānoa, USA.""}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Rand-Giovannetti', 'Affiliation': ""Department of Psychology, University of Hawai'i at Mānoa, USA.""}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Stefano', 'Affiliation': ""Department of Psychology, University of Hawai'i at Mānoa, USA.""}, {'ForeName': 'Janet D', 'Initials': 'JD', 'LastName': 'Latner', 'Affiliation': ""Department of Psychology, University of Hawai'i at Mānoa, USA.""}]",Nutrition and health,['10.1177/0260106020926834']
2855,32135010,A gene-diet interaction-based score predicts response to dietary fat in the Women's Health Initiative.,"BACKGROUND


Although diet response prediction for cardiometabolic risk factors (CRFs) has been demonstrated using single genetic variants and main-effect genetic risk scores, little investigation has gone into the development of genome-wide diet response scores.
OBJECTIVE


We sought to leverage the multistudy setup of the Women's Health Initiative cohort to generate and test genetic scores for the response of 6 CRFs (BMI, systolic blood pressure, LDL cholesterol, HDL cholesterol, triglycerides, and fasting glucose) to dietary fat.
METHODS


A genome-wide interaction study was undertaken for each CRF in women (n ∼ 9000) not participating in the dietary modification (DM) trial, which focused on the reduction of dietary fat. Genetic scores based on these analyses were developed using a pruning-and-thresholding approach and tested for the prediction of 1-y CRF changes as well as long-term chronic disease development in DM trial participants (n ∼ 5000).
RESULTS


Only 1 of these genetic scores, for LDL cholesterol, predicted changes in the associated CRF. This 1760-variant score explained 3.7% (95% CI: 0.09, 11.9) of the variance in 1-y LDL cholesterol changes in the intervention arm but was unassociated with changes in the control arm. In contrast, a main-effect genetic risk score for LDL cholesterol was not useful for predicting dietary fat response. Further investigation of this score with respect to downstream disease outcomes revealed suggestive differential associations across DM trial arms, especially with respect to coronary heart disease and stroke subtypes.
CONCLUSIONS


These results lay the foundation for the combination of many genome-wide gene-diet interactions for diet response prediction while highlighting the need for further research and larger samples in order to achieve robust biomarkers for use in personalized nutrition.",2020,"This 1760-variant score explained 3.7% (95% CI: 0.09, 11.9) of the variance in 1-y LDL cholesterol changes in the intervention arm but was unassociated with changes in the control arm.","['women (n ∼ 9000) not participating in the dietary modification (DM) trial, which focused on the reduction of dietary fat']",[],"['LDL cholesterol', '1-y LDL cholesterol changes', '6 CRFs (BMI, systolic blood pressure, LDL cholesterol, HDL cholesterol, triglycerides, and fasting glucose) to dietary fat']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4708915', 'cui_str': '9000'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}]",[],"[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}]",,0.0283568,"This 1760-variant score explained 3.7% (95% CI: 0.09, 11.9) of the variance in 1-y LDL cholesterol changes in the intervention arm but was unassociated with changes in the control arm.","[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Westerman', 'Affiliation': 'Jean Mayer-United States Department of Agriculture Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Laurence D', 'Initials': 'LD', 'LastName': 'Parnell', 'Affiliation': 'Jean Mayer-United States Department of Agriculture Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Sebastiani', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jacques', 'Affiliation': 'Jean Mayer-United States Department of Agriculture Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'DeMeo', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Ordovás', 'Affiliation': 'Jean Mayer-United States Department of Agriculture Human Nutrition Research Center on Aging, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa037']
2856,30563829,Rapamycin Prevents Surgery-Induced Immune Dysfunction in Patients with Bladder Cancer.,"The mechanistic target of rapamycin (mTOR) integrates environmental inputs to regulate cellular growth and metabolism in tumors. However, mTOR also regulates T-cell differentiation and activation, rendering applications of mTOR inhibitors toward treating cancer complex. Preclinical data support distinct biphasic effects of rapamycin, with higher doses directly suppressing tumor cell growth and lower doses enhancing T-cell immunity. To address the translational relevance of these findings, the effects of the mTOR complex 1 (mTORC1) inhibitor, rapamycin, on tumor and T cells were monitored in patients undergoing cystectomy for bladder cancer. MB49 syngeneic murine bladder cancer models were tested to gain mechanistic insights. Surgery-induced T-cell exhaustion in humans and mice and was associated with increased pulmonary metastasis and decreased PD-L1 antibody efficacy in mouse bladder cancer. At 3 mg orally daily, rapamycin concentrations were 2-fold higher in bladder tissues than in blood. Rapamycin significantly inhibited tumor mTORC1, shown by decreased rpS6 phosphorylation in treated versus control patients ( P  = 0.008). Rapamycin reduced surgery-induced T-cell exhaustion in patients, evidenced by a significant decrease in the prevalence of dysfunctional programmed death-1 (PD-1)-expressing T cells. Grade 3 to 4 adverse event rates were similar between groups, but rapamycin-treated patients had a higher rate of wound complications versus controls. In conclusion, surgery promoted bladder cancer metastasis and decreased the efficacy of postoperative bladder cancer immunotherapy. Low-dose (3 mg daily) oral rapamycin has favorable pharmacodynamic and immune modulating activity in surgical patients and has the potential to decrease surgery-induced immune dysfunction.",2019,"Rapamycin reduced surgery-induced T-cell exhaustion in patients, evidenced by a significant decrease in the prevalence of dysfunctional programmed death-1 (PD-1)-expressing T cells.","['Patients with Bladder Cancer', 'surgical patients', 'patients undergoing cystectomy for bladder cancer', 'MB49 syngeneic murine bladder cancer models']","['mTOR complex 1 (mTORC1) inhibitor, rapamycin', 'rapamycin', 'rapamycin (mTOR', 'Rapamycin']","['surgery-induced T-cell exhaustion', 'rate of wound complications', 'rapamycin concentrations', 'Grade 3 to 4 adverse event rates', 'bladder cancer metastasis', 'prevalence of dysfunctional programmed death-1 (PD-1)-expressing T cells', 'pulmonary metastasis and decreased PD-L1 antibody efficacy', 'rpS6 phosphorylation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}, {'cui': 'C0026809', 'cui_str': 'Mus'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C3888046', 'cui_str': 'Target of Rapamycin Complex 1'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}]",,0.0300555,"Rapamycin reduced surgery-induced T-cell exhaustion in patients, evidenced by a significant decrease in the prevalence of dysfunctional programmed death-1 (PD-1)-expressing T cells.","[{'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Svatek', 'Affiliation': 'Experimental Developmental Therapeutics (EDT) Program, UT Health MD Anderson, San Antonio, Texas. svatek@uthscsa.edu curielt@uthscsa.edu.'}, {'ForeName': 'Niannian', 'Initials': 'N', 'LastName': 'Ji', 'Affiliation': 'Experimental Developmental Therapeutics (EDT) Program, UT Health MD Anderson, San Antonio, Texas.'}, {'ForeName': 'Essel', 'Initials': 'E', 'LastName': 'de Leon', 'Affiliation': 'Department of Pathology, UT Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Neelam Z', 'Initials': 'NZ', 'LastName': 'Mukherjee', 'Affiliation': 'Experimental Developmental Therapeutics (EDT) Program, UT Health MD Anderson, San Antonio, Texas.'}, {'ForeName': 'Aashish', 'Initials': 'A', 'LastName': 'Kabra', 'Affiliation': 'Department of Urology, UT Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Hurez', 'Affiliation': 'Experimental Developmental Therapeutics (EDT) Program, UT Health MD Anderson, San Antonio, Texas.'}, {'ForeName': 'Marlo', 'Initials': 'M', 'LastName': 'Nicolas', 'Affiliation': 'Department of Pathology, UT Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Michalek', 'Affiliation': 'Department of Epidemiology and Biostatistics, UT Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Javors', 'Affiliation': 'Department of Psychiatry, UT Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Wheeler', 'Affiliation': 'Experimental Developmental Therapeutics (EDT) Program, UT Health MD Anderson, San Antonio, Texas.'}, {'ForeName': 'Z Dave', 'Initials': 'ZD', 'LastName': 'Sharp', 'Affiliation': 'The Population Science and Prevention (PSP) Program, Mays Cancer Center at UT Health MD Anderson, San Antonio, Texas.'}, {'ForeName': 'Carolina B', 'Initials': 'CB', 'LastName': 'Livi', 'Affiliation': 'Department of Molecular Medicine, UT Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Zhen-Ju', 'Initials': 'ZJ', 'LastName': 'Shu', 'Affiliation': 'Experimental Developmental Therapeutics (EDT) Program, UT Health MD Anderson, San Antonio, Texas.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Henkes', 'Affiliation': 'Department of Pathology, CHRISTUS Santa Rosa Medical Center, San Antonio, Texas.'}, {'ForeName': 'Tyler J', 'Initials': 'TJ', 'LastName': 'Curiel', 'Affiliation': 'Experimental Developmental Therapeutics (EDT) Program, UT Health MD Anderson, San Antonio, Texas. svatek@uthscsa.edu curielt@uthscsa.edu.'}]",Cancer immunology research,['10.1158/2326-6066.CIR-18-0336']
2857,31078637,His Corrective Pacing or Biventricular Pacing for Cardiac Resynchronization in Heart Failure.,,2019,,[],['His Corrective Pacing or Biventricular Pacing for Cardiac Resynchronization'],[],[],"[{'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C2936372', 'cui_str': 'Biventricular Pacing'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}]",[],,0.013507,,"[{'ForeName': 'Gaurav A', 'Initials': 'GA', 'LastName': 'Upadhyay', 'Affiliation': ''}, {'ForeName': 'Pugazhendhi', 'Initials': 'P', 'LastName': 'Vijayaraman', 'Affiliation': ''}, {'ForeName': 'Hemal M', 'Initials': 'HM', 'LastName': 'Nayak', 'Affiliation': ''}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Verma', 'Affiliation': ''}, {'ForeName': 'Gopi', 'Initials': 'G', 'LastName': 'Dandamudi', 'Affiliation': ''}, {'ForeName': 'Parikshit S', 'Initials': 'PS', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Moeen', 'Initials': 'M', 'LastName': 'Saleem', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mandrola', 'Affiliation': ''}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Genovese', 'Affiliation': ''}, {'ForeName': 'Roderick', 'Initials': 'R', 'LastName': 'Tung', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.04.026']
2858,31122045,Sexual risk behavior among HIV-infected women in South Africa at 12-months postpartum.,"The postnatal period is a time of increased susceptibility to HIV infection and superinfection for postpartum women, sexual partners, and infants. This study examined the effect of a prevention to mother-to-child transmission of HIV intervention compared to standard care, and factors associated with unprotected last sex and inconsistent condom use at 12-months postpartum. Participants were  N  = 1399 HIV-infected women 6-30 weeks pregnant ( M  = 18 weeks (SD = 5.75)) assessed during pregnancy and 12-months postpartum. Women were aged an average of 28 (SD = 5.82); 48% reported 10-11 years of education. Older age (adjusted odds ratio [AOR] = 1.00) and being employed (AOR = 1.51) were associated with greater odds of unprotected sex at 12-month postpartum. Disclosure of HIV status (AOR = 0.64) and greater male involvement during pregnancy (AOR = 0.92) were associated with lower odds of unprotected sex at 12-month postpartum. HIV negative or unknown partner status (AOR = 0.45) and greater depressive symptoms (AOR = 0.97) were associated with lower odds of inconsistent condom use at 12-months postpartum. The intervention was not associated with reduced sexual risk behavior. Future studies should address male involvement and consider measurement of culturally tailored male involvement constructs for men South Africa. Perinatal women may require support for sexual communication and gender equity to reduce sexual risk.",2019,Older age (adjusted odds ratio [AOR] = 1.00) and being employed (AOR = 1.51) were associated with greater odds of unprotected sex at 12-month postpartum.,"['Women were aged an average of 28 (SD\u2009=\u20095.82); 48% reported 10-11 years of education', 'men South Africa', 'Perinatal women', 'Participants were  N \u2009=\u20091399 HIV-infected women 6-30 weeks pregnant ', 'HIV-infected women in South Africa at 12-months postpartum']",['HIV intervention'],"['HIV negative or unknown partner status', 'sexual risk behavior', 'Disclosure of HIV status', 'Sexual risk behavior', 'depressive symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",1399.0,0.0327621,Older age (adjusted odds ratio [AOR] = 1.00) and being employed (AOR = 1.51) were associated with greater odds of unprotected sex at 12-month postpartum.,"[{'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Jones', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Violeta J', 'Initials': 'VJ', 'LastName': 'Rodriguez', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Lissa N', 'Initials': 'LN', 'LastName': 'Mandell', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Tae Kyoung', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'c Department of Public Health Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Weiss', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Peltzer', 'Affiliation': 'd HIV/AIDS/STIs and TB (HAST) Research Programme , Human Sciences Research Council , Pretoria , South Africa.'}]",AIDS care,['10.1080/09540121.2019.1620168']
2859,31301135,HLA-I Associated Adaptation Dampens CD8 T-Cell Responses in HIV Ad5-Vectored Vaccine Recipients.,"HLA-I-associated human immunodeficiency virus (HIV) adaptation is known to negatively affect disease progression and CD8 T-cell responses. We aimed to assess how HLA-I-associated adaptation affects HIV vaccine-induced CD8 T-cell responses in 2 past vaccine efficacy trials. We found that vaccine-encoded adapted epitopes were less immunogenic than vaccine-encoded nonadapted epitopes, and adapted epitope-specific responses were less polyfunctional than nonadapted epitope-specific responses. Along those lines, vaccine recipients with higher HLA-I adaptation to the Gag vaccine insert mounted less polyfunctional CD8 T-cell responses at the protein level. Breadth of response, which correlated with viral control in recipients who became infected, is also dampened by HLA-I adaptation. These findings suggest that HLA-I-associated adaptation is an important consideration for strategies aiming to induce robust CD8 T-cell responses.",2019,"Breadth of response, which correlated with viral control in recipients who became infected, is also dampened by HLA-I adaptation.",['HIV Ad5-Vectored Vaccine Recipients'],[],"['polyfunctional CD8 T-cell responses', 'HLA-I Associated Adaptation Dampens CD8 T-Cell Responses']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0528480', 'cui_str': 'Presenilin 2'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],"[{'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]",,0.017682,"Breadth of response, which correlated with viral control in recipients who became infected, is also dampened by HLA-I adaptation.","[{'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Boppana', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sterrett', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Files', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Qin', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fiore-Gartland', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Kristen W', 'Initials': 'KW', 'LastName': 'Cohen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'De Rosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Goepfert', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz368']
2860,32436964,Hem-o-lok clips versus intracorporeal knotting for the closure of the appendix stump in laparoscopic appendectomy: A prospective randomized study.,"BACKGROUND


In this study, we aimed to evaluate the superiority of intracorporeal sutures and Hem-o-lok clips about efficiency, reliability and cost.
METHODS


We performed laparoscopic surgery for acute appendicitis in this study. Appendiceal stump was closed by Hem-o-lok clips (Group I) and intracorporeal knotting (Group II) in a randomized manner. Groups were compared for demographic data (age, sex, body mass index, American Society of Anesthesiologists score) operation time, total cost, 2.6.12.24.hours and 7th day pain score.
RESULTS


Demographic data, such as age, gender and BMI, were similar between groups (p>0.05). There was no significant difference between the groups concerning peroperative and postoperative complications (p>0.05). No postoperative nausea, vomiting, ileus and intraabdominal abscess were observed in patients. There was no significant difference between the groups about duration of operation, length of hospital stay and cost analysis (p>0.05). There was no significant difference in pain scores of groups. The effect of the operation type on pain scores was not statistically significant (p>0.05).
CONCLUSION


This study showed that both intracorporeal knotting and Hem-o-loc clips were effective, reliable and similar cost-effective in laparoscopic appendectomy. The decision should be based on the surgeon's experience.",2020,"There was no significant difference between the groups about duration of operation, length of hospital stay and cost analysis (p>0.05).",['laparoscopic appendectomy'],"['Hem-o-lok clips versus intracorporeal knotting', 'Appendiceal stump was closed by Hem-o-lok clips (Group I) and intracorporeal knotting', 'intracorporeal knotting and Hem-o-loc clips', 'intracorporeal sutures and Hem-o-lok clips', 'laparoscopic surgery']","['duration of operation, length of hospital stay and cost analysis (p>0.05', 'postoperative nausea, vomiting, ileus and intraabdominal abscess', 'pain scores', 'peroperative and postoperative complications']","[{'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}]","[{'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0560032', 'cui_str': 'knot'}, {'cui': 'C2711602', 'cui_str': 'Appendiceal stump'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0234425', 'cui_str': 'Level of consciousness'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010171', 'cui_str': 'Analysis, Cost'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0230168', 'cui_str': 'Abdominopelvic cavity structure'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",,0.029566,"There was no significant difference between the groups about duration of operation, length of hospital stay and cost analysis (p>0.05).","[{'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Ureyen', 'Affiliation': 'Department of General Surgery, Universty of Health Sciences, İzmir Bozyaka Training and Research Hospital, İzmir-Turkey.'}, {'ForeName': 'Sedat', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Universty of Health Sciences, İzmir Bozyaka Training and Research Hospital, İzmir-Turkey.'}, {'ForeName': 'Emrah', 'Initials': 'E', 'LastName': 'Dadalı', 'Affiliation': 'Department of General Surgery, Universty of Health Sciences, İzmir Bozyaka Training and Research Hospital, İzmir-Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Yıldırım', 'Affiliation': 'Department of General Surgery, Universty of Health Sciences, İzmir Bozyaka Training and Research Hospital, İzmir-Turkey.'}, {'ForeName': 'Enver', 'Initials': 'E', 'LastName': 'İlhan', 'Affiliation': 'Department of General Surgery, Universty of Health Sciences, İzmir Bozyaka Training and Research Hospital, İzmir-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2019.02248']
2861,32436800,Effect of a mobile phone-assisted postpartum family planning service on the use of long-acting reversible contraception: a randomised controlled trial.,"Objective:  The aim of the study was to evaluate the effect of adding mobile phone call reminders to a postpartum family planning service on the initiation of long-acting reversible contraception (LARC). Methods:  A randomised, open-label controlled trial (ClinicalTrials.gov NCT03135288) was carried out at a university hospital between July 2017 and March 2019. The study comprised women who delivered a live birth at >28 weeks' gestation and who requested birth spacing for ≥1 year. Eligible women were recruited and randomised to two groups. The study group received contraceptive counselling and two reminders of their first postpartum appointment, one week and again 48 h before the appointment. The control group received contraceptive counselling but no mobile phone reminders of their first postpartum appointment. The primary outcome was the rate of initiation of a LARC method in the first 6 months postpartum. Results:  The study comprised 500 participants in each group. The rate of initiation and continuation of a LARC method was significantly higher in the study group compared with the control group (30.2% vs 8.4% and 95.4% vs 83.3%, respectively;  p  < .001). In the study group, 382 (76.4%) women had started using a contraceptive method during the first 6 months, compared with 218 (43.6%) women in the control group ( p  < .001). Conclusion:  Using mobile phone reminders as part of the postpartum service increases the frequency of women who attends family planning clinics and initiates contraception, including a LARC methods, as well as the proportion who continue LARC use through the first 6 months postpartum.",2020,"The rate of initiation and continuation of a LARC method was significantly higher in the study group compared with the control group (30.2% vs 8.4% and 95.4% vs 83.3%, respectively;  ","['long-acting reversible contraception', '500 participants in each group', 'Eligible women', 'university hospital between July 2017 and March 2019', ""women who delivered a live birth at >28 weeks' gestation and who requested birth spacing for ≥1 year""]","['mobile phone call reminders', 'contraceptive counselling but no mobile phone reminders of their first postpartum appointment', 'contraceptive counselling', 'mobile phone-assisted postpartum family planning service']","['rate of initiation and continuation of a LARC method', 'rate of initiation of a LARC method']","[{'cui': 'C4505307', 'cui_str': 'Long-Acting Reversible Contraception'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}]","[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",,0.188632,"The rate of initiation and continuation of a LARC method was significantly higher in the study group compared with the control group (30.2% vs 8.4% and 95.4% vs 83.3%, respectively;  ","[{'ForeName': 'Omar M', 'Initials': 'OM', 'LastName': 'Shaaban', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Treza', 'Initials': 'T', 'LastName': 'Saber', 'Affiliation': 'Department of Obstetrics and Gynaecological Nursing, Faculty of Nursing, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Entisar', 'Initials': 'E', 'LastName': 'Youness', 'Affiliation': 'Department of Obstetrics and Gynaecological Nursing, Faculty of Nursing, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Farouk', 'Affiliation': 'Department of Obstetrics and Gynaecological Nursing, Faculty of Nursing, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abbas', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception,['10.1080/13625187.2020.1764528']
2862,32436902,Efficacy of omega 3 fatty acid as an adjunct in the management of chronic periodontitis: A randomized controlled trial.,"Background


: Periodontitis is conventionally treated with both surgical and nonsurgical methods. Various adjuncts have been used previously with compromised efficacy. Recently omega-3(ώ-3) polyunsaturated fatty acids (PUFA) including docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) were shown to have therapeutic anti-inflammatory and protective actions in inflammatory diseases including periodontitis. The purpose of the present study was to evaluate and compare the clinical efficacy of ώ-3 fatty acids as an adjunct to scaling and root planing in the treatment of periodontitis.
Methods


110 Patients were selected for the study out of which 20 were excluded (12 not meeting the inclusion criteria and 8 refused to participate). 90 patients (48 in test and 42 in the control group) after randomisation through a coin toss method were enrolled in a single-blind randomised controlled trial conducted in the Periodontics department of a dental college. Full mouth subgingival scaling and root planing and ώ-3 fatty acid 500 mg (EPA/DHA 180/120 mg), BD daily for 1 month was given to the test group and subgingival scaling and root planing only was given to the control group. Clinical parameters like probing pocket depth, clinical attachment level, plaque index and gingival index were recorded at baseline, 1 and 3 months and were compared.
Results


Statistical analyses demonstrated a significant reduction in probing pocket depth (t = 65.56, P = 0.000) and (t = 51.69, P = 0.000) at 1 and 3 months, respectively, in test group compared to baseline and control group. There was a significant gain in clinical attachment level (t = 63.29, P = 0.000) and (t = 31.03, P = 0.000) at 1 and 3 months, respectively, in test group compared to baseline and control group. The gingival index shows an appreciable reduction in both groups, and in test group, it is statistically significant at 3 months (t = 2.15, P = 0.03). There was no statistical significant reduction in plaque index at 3 months (t = 0, P = 0.997).
Conclusion


The present study showed that adjunctive use of ώ-3 fatty acids proved to be beneficial over scaling and root planing alone in the treatment of chronic moderate periodontitis. The beneficial effects were in terms of significant improvements in clinical parameters, probing pocket depth, and clinical attachment level and gingival index. Dietary modulation is now emerging as an adjunct to periodontal therapy. Hence, omega-3 fatty acid may be used routinely in the management of chronic periodontitis.",2020,"Results


Statistical analyses demonstrated a significant reduction in probing pocket depth (t = 65.56, P = 0.000) and (t = 51.69, P = 0.000) at 1 and 3 months, respectively, in test group compared to baseline and control group.","['90 patients (48 in test and 42 in the control group) after randomisation through a coin toss method were enrolled in a single-blind randomised controlled trial conducted in the Periodontics department of a dental college', 'chronic periodontitis', '110 Patients were selected for the study out of which 20 were excluded (12 not meeting the inclusion criteria and 8 refused to participate', 'chronic moderate periodontitis']","['ώ-3 fatty acids', 'omega 3 fatty acid', 'fatty acid 500 mg (EPA/DHA', 'omega-3(ώ-3) polyunsaturated fatty acids (PUFA) including docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA', 'omega-3 fatty acid']","['clinical attachment level', 'Clinical parameters like probing pocket depth, clinical attachment level, plaque index and gingival index', 'probing pocket depth', 'clinical parameters, probing pocket depth, and clinical attachment level and gingival index', 'gingival index', 'plaque index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0524669', 'cui_str': 'Coins'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031098', 'cui_str': 'Periodontics'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}]",110.0,0.0651708,"Results


Statistical analyses demonstrated a significant reduction in probing pocket depth (t = 65.56, P = 0.000) and (t = 51.69, P = 0.000) at 1 and 3 months, respectively, in test group compared to baseline and control group.","[{'ForeName': 'Shirish K', 'Initials': 'SK', 'LastName': 'Kujur', 'Affiliation': 'Department of Oral Pathology, Govt Dental College, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Goswami', 'Affiliation': 'Department of Oral Pathology, Govt Dental College, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Anand M', 'Initials': 'AM', 'LastName': 'Nikunj', 'Affiliation': 'Department of Oral Pathology, Govt Dental College, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Gangesh', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Department of Oral Pathology, Govt Dental College, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Bandhe', 'Affiliation': 'Department of Oral Pathology, Govt Dental College, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Himanta', 'Initials': 'H', 'LastName': 'Ghritlahre', 'Affiliation': 'Department of Oral Pathology, Govt Dental College, Raipur, Chhattisgarh, India.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_647_18']
2863,32436761,Glyceryl trinitrate in first-episode psychosis unmedicated with antipsychotics: A randomised controlled pilot study.,"BACKGROUND


There is a pressing need for new classes of treatment for psychosis. A key therapeutic target for novel compounds is the NMDA receptor, which may be modulated by nitric oxide donors such as sodium nitroprusside (SNP). Recent studies of SNP in patients with psychosis have mixed results, and the drug has to be administered intravenously. Glyceryl trinitrate (GTN) is a well-established cardiovascular medicine that is also a nitric oxide donor, and can be given orally.
AIMS


We explored the safety and potential effects of GTN in unmedicated patients with a first episode of psychosis.
METHODS


This was a single-centre, randomised, double-blind, placebo-controlled trial from December 2016 to April 2019 (ClinicalTrials.gov identifier: NCT02906553). Patients received 3 × sprays of GTN or placebo for three consecutive days, and were re-assessed on Days 1, 2, 3 and 7. The primary outcome was cognition (Jumping to Conclusions task), secondary outcomes were symptoms (Positive and Negative Syndrome Scale (PANSS)), verbal memory (Hopkins Verbal Learning task), and mood (Bond-Lader Visual Analogue Scales).
RESULTS


Nineteen patients were randomised, and 13 participants were included in the analyses. Compared with placebo, GTN was well tolerated, but was not associated with significant effects on cognition, symptoms, or mood. Bayesian statistics indicate that our results were 2× more likely under the null hypothesis than the alternative hypothesis, providing anecdotal evidence that GTN does not improve psychotic symptoms.
CONCLUSIONS


We found no indication of an effect of GTN on symptoms of psychosis or cognition.",2020,"Compared with placebo, GTN was well tolerated, but was not associated with significant effects on cognition, symptoms, or mood.","['Nineteen patients were randomised, and 13 participants were included in the analyses', 'patients with psychosis', 'unmedicated patients with a first episode of psychosis', 'controlled trial from December 2016 to April 2019 (ClinicalTrials.gov identifier', 'first-episode psychosis unmedicated with antipsychotics']","['GTN', 'Glyceryl trinitrate (GTN', 'SNP', 'placebo, GTN', '3 × sprays of GTN or placebo', 'Glyceryl trinitrate', 'placebo']","['tolerated', 'cognition (Jumping to Conclusions task), secondary outcomes were symptoms (Positive and Negative Syndrome Scale (PANSS)), verbal memory (Hopkins Verbal Learning task), and mood (Bond-Lader Visual Analogue Scales', 'symptoms of psychosis or cognition', 'psychotic symptoms', 'cognition, symptoms, or mood']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}]",19.0,0.469584,"Compared with placebo, GTN was well tolerated, but was not associated with significant effects on cognition, symptoms, or mood.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Merritt', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Catalan', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Cowley', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Arsime', 'Initials': 'A', 'LastName': 'Demjaha', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McGuire', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Cooper', 'Affiliation': 'Newham Centre for Mental Health, Unit for Social and Community Psychiatry, Queen Mary University of London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Morrison', 'Affiliation': 'Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120922967']
2864,32436899,Treatment of miller type I and II gingival recession defects using three-dimensional porcine collagen matrix with coronally advanced flap: A randomized clinical split-mouth trial (a 1-year follow-up).,"Introduction


The main goal of periodontal plastic surgery is obtaining complete root coverage (CRC) and an optimal appearance.
Aim


The aim of this study was to evaluate the effectiveness of a three-dimensional porcine collagen matrix (PCM) with coronally advanced flap (CAF) in treating of Miller type I and II gingival recession (GR).
Materials and Methods


Twenty patients were enrolled in this study, presenting 40 Miller type I and II GR. Patients were randomized into test group (PCM + CAF) and control group [connective tissue graft (CTG + CAF)]. Clinical parameters such as recession depth (RD), probing depth, clinical attachment level (CAL), and width of keratinized gingiva (WKG) were evaluated at baseline and 12 months later. Root coverage percentage (RC%) and CRC were assessed at 12 months post surgically. Statistical analysis was performed using independent t-test for intergroup comparison. Statistical significance was set at 0.05.
Results


The mean RD at 12 months was 0.20 mm for the test group and 0.12 mm for the control group, whereas the mean RC% was 94.22% for PCM + CAF and 96.48% for CTG + CAF. CRC was higher in CTG + CAF with 80%. CAL gain was 2.05 and 2.07 mm in the test and control sites, respectively. The gain of WKG was 1.35 and 1.30 mm in the test and control sites, respectively. Patient esthetic satisfaction at 12 months post surgically in both groups was equivalent.
Conclusion


Within the limits of this study, using of PCM + CAF in treating GR is a successful and effective treatment option and could serve as an alternative to CTGs.",2020,"The mean RD at 12 months was 0.20 mm for the test group and 0.12 mm for the control group, whereas the mean RC% was 94.22% for PCM + CAF and 96.48% for CTG + CAF.","['Twenty patients were enrolled in this study, presenting 40 Miller type I and II GR']","['PCM + CAF', 'test group (PCM + CAF) and control group [connective tissue graft (CTG + CAF', 'three-dimensional porcine collagen matrix (PCM) with coronally advanced flap (CAF', 'miller type I and II gingival recession defects using three-dimensional porcine collagen matrix with coronally advanced flap']","['mean RC', 'CAL gain', 'Patient esthetic satisfaction', 'mean RD', 'CRC', 'Root coverage percentage (RC%) and CRC', 'recession depth (RD), probing depth, clinical attachment level (CAL), and width of keratinized gingiva (WKG', 'gain of WKG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}]","[{'cui': 'C3486131', 'cui_str': 'Pork collagen preparation'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}]",20.0,0.0540649,"The mean RD at 12 months was 0.20 mm for the test group and 0.12 mm for the control group, whereas the mean RC% was 94.22% for PCM + CAF and 96.48% for CTG + CAF.","[{'ForeName': 'Haydar', 'Initials': 'H', 'LastName': 'Barakat', 'Affiliation': 'Department of Periodontology, Dental Faculty, Damascus University, Damascus, Syria.'}, {'ForeName': 'Suleiman', 'Initials': 'S', 'LastName': 'Dayoub', 'Affiliation': 'Department of Periodontology, Dental Faculty, Damascus University, Damascus, Syria.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_897_18']
2865,32436911,Microleakage patterns of glass ionomer cement at cement-band and cement-enamel interfaces in primary teeth.,"Context


In-vitro studies of microleakage are an initial screening method to assess the maximum theoretical loss of sealing ability in-vivo.
Aims


Our objective was to determine and compare microleakage patterns of conventional glass ionomer cement (GIC) and resin-modified GIC (RMGIC) for band cementation.
Methods


Forty caries-free second primary molars were randomly divided into two groups of 20 teeth each. Preformed molar bands in the two groups were cemented to enamel with one of two types of cement: Conventional GIC (Fuji I, GC Corporation; Tokyo, Japan) and RMGIC (Fuji Plus, GC Corporation; Tokyo, Japan). A dye penetration method was used for microleakage evaluation. Microleakage was determined by a stereomicroscope for the cement-band and cement-enamel interfaces.
Statistical Analysis Used


Statistical analysis was performed with Kruskal-Wallis and Mann-Whitney U tests.
Results


The mean microleakage value for conventional GIC (Fuji I) at cement-band and cement-enamel interfaces was 2.41 mm and 2.15 mm, respectively. The mean microleakage value for RMGIC (Fuji Plus) at cement-band and cement-enamel interfaces was 0.44 mm and 0.46 mm, respectively. Compared to conventional GIC, RMGIC showed less microleakage at both cement-band and cement-enamel interfaces. P < 0.001 and it was statistically highly significant.
Conclusions


Bands cemented with RMGIC had significantly less microleakage between the cement-band and cement-enamel interfaces than conventional GIC.",2020,"Compared to conventional GIC, RMGIC showed less microleakage at both cement-band and cement-enamel interfaces.","['Microleakage patterns of glass ionomer cement at cement-band and cement-enamel interfaces in primary teeth', 'Methods\n\n\nForty caries-free second primary molars']","['conventional glass ionomer cement (GIC) and resin-modified GIC (RMGIC', 'conventional GIC, RMGIC']","['Microleakage', 'mean microleakage value', 'microleakage', 'mean microleakage value for RMGIC']","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",40.0,0.0352895,"Compared to conventional GIC, RMGIC showed less microleakage at both cement-band and cement-enamel interfaces.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Shankar', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, SRM Dental College and Hospital, Ramapuram, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Venkatesan', 'Affiliation': 'Department of Restorative Dentistry, Al Farabi Dental College, Jeddah, Saudi Arabia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Senthil', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, SRM Dental College and Hospital, Ramapuram, Chennai, Tamil Nadu, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Trophimus', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, SRM Dental College and Hospital, Ramapuram, Chennai, Tamil Nadu, India.'}, {'ForeName': 'C U', 'Initials': 'CU', 'LastName': 'Arthilakshmi', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Chettinad Dental College and Research Institute, Kelambakkam, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Philomine', 'Initials': 'P', 'LastName': 'Princy', 'Affiliation': 'Department of Restorative Dentistry, Al Farabi Dental College, Jeddah, Saudi Arabia.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_850_19']
2866,32436733,Quality of life of women using the etonogestrel long-acting reversible contraceptive implant after abortion for unplanned pregnancy.,"Objectives:  The aims of the study were to investigate the effect of a subcutaneous etonogestrel-containing contraceptive implant on the quality of life (QoL) and sexual function of women who had undergone termination of an unplanned pregnancy. Methods:  At pregnancy termination 140 women received contraceptive counselling on the etonogestrel implant. The Short Form-36 questionnaire, the Female Sexual Function Index and the Female Sexual Distress Scale were used to investigate, respectively, the QoL, sexual function and sexual distress of the women at baseline and at 6, 12, 24 and 36 months of follow-up. Results:  The study group comprised 86 (61.4%) women who chose to use the contraceptive implant. The control group comprised 28 (20.0%) women who chose to use short-acting reversible contraception (SARC) and 26 (18.6%) women who chose not to use hormonal contraception. In the women not using hormonal contraception there were 23 (88.5%) unintended pregnancies before the end of the 3 year study period. QoL, sexual function and sexual distress improved in the study group from the 6 months follow-up until the end of the study ( p  < 0.001). QoL ( p  < 0.02) and sexuality ( p  < 0.001) gradually improved in the control group after 24 and 12 months of follow-up, respectively. None of the women using the etonogestrel implant became pregnant during the study. Inter-group analysis showed better improvement in QoL, sexual function and sexual distress in the study group than in the control group from 6 months ( p  < 0.004) until the end of the study ( p  < 0.001). Conclusion:  Compared with SARC and non-hormonal contraception, the contraceptive implant promoted better QoL and sexuality in users and reduced the incidence of unplanned pregnancy. However, the women who opted for SARC or non-hormonal contraception did so because of the lower cost compared with that of the contraceptive implant.",2020,"Inter-group analysis showed better improvement in QoL, sexual function and sexual distress in the study group than in the control group from 6 months ( p  < 0.004) until the end of the study ( p  < 0.001).","['28 (20.0%) women who chose to use short-acting reversible contraception (SARC) and 26 (18.6%) women who chose not to use hormonal contraception', 'of women using the etonogestrel long-acting reversible contraceptive implant after abortion for unplanned pregnancy', '86 (61.4%) women who chose to use the contraceptive implant', 'women who had undergone termination of an unplanned pregnancy']","['SARC and non-hormonal contraception', 'contraceptive counselling', 'subcutaneous etonogestrel-containing contraceptive implant']","['QoL', 'sexuality', 'quality of life (QoL) and sexual function', 'QoL, sexual function and sexual distress', 'QoL and sexuality', 'Quality of life', 'Short Form-36 questionnaire, the Female Sexual Function Index and the Female Sexual Distress Scale', 'incidence of unplanned pregnancy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C0047683', 'cui_str': 'Etonogestrel'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1657106', 'cui_str': 'Contraceptive implant'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0041747', 'cui_str': 'Unplanned pregnancy'}]","[{'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0047683', 'cui_str': 'Etonogestrel'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1657106', 'cui_str': 'Contraceptive implant'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041747', 'cui_str': 'Unplanned pregnancy'}]",,0.0453151,"Inter-group analysis showed better improvement in QoL, sexual function and sexual distress in the study group than in the control group from 6 months ( p  < 0.004) until the end of the study ( p  < 0.001).","[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Caruso', 'Affiliation': 'Sexology Research Group, Gynaecology Clinic, Department of General Surgery and Medical Surgical Specialties, School of Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Salvatore Giovanni', 'Initials': 'SG', 'LastName': 'Vitale', 'Affiliation': 'Sexology Research Group, Gynaecology Clinic, Department of General Surgery and Medical Surgical Specialties, School of Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Fava', 'Affiliation': 'Sexology Research Group, Gynaecology Clinic, Department of General Surgery and Medical Surgical Specialties, School of Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Salvatore Di', 'Initials': 'SD', 'LastName': 'Pasqua', 'Affiliation': 'Sexology Research Group, Gynaecology Clinic, Department of General Surgery and Medical Surgical Specialties, School of Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Agnese Maria Chiara', 'Initials': 'AMC', 'LastName': 'Rapisarda', 'Affiliation': 'Sexology Research Group, Gynaecology Clinic, Department of General Surgery and Medical Surgical Specialties, School of Medicine, University of Catania, Catania, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cianci', 'Affiliation': ""Department of Woman, Child and General and Specialised Surgery, University of Campania 'Luigi Vanvitelli', Naples, Italy.""}]",The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception,['10.1080/13625187.2020.1760240']
2867,32436641,"Ultra Rapid Lispro Lowers Postprandial Glucose and More Closely Matches Normal Physiological Glucose Response Compared to Other Rapid Insulin Analogs: A Phase 1 Randomized, Crossover Study.","AIMS


Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose (PPG) control. This study compared the pharmacokinetics (PK) and glucocodynamics (GD) of URLi, Fiasp®, Humalog®, and NovoRapid® in patients with type 1 diabetes (T1D).
MATERIALS AND METHODS


This was a randomized, double-blind, 4-period, crossover study, conducted in 68 patients with T1D. Patients received the same individualized subcutaneous dose of each study drug immediately prior to a liquid test meal. For comparison, 12 healthy subjects received the same test meal.
RESULTS


URLi had a significantly faster insulin absorption compared to the other insulins tested. Early half maximal drug concentration was reached 13 min after URLi, which was 6 min faster than Fiasp, 13 min faster than Humalog, and 14 min faster than NovoRapid (all p<0.0001). Early insulin exposure was significantly greater and late insulin exposure was reduced after URLi compared to the other insulins. URLi achieved the greatest numerical reduction in PPG at 2 hours post-meal (7 mg/dL vs Fiasp) and significant differences to Humalog (21 mg/dL) and Novo Rapid (29 mg/dL). Additionally, glucose excursions over the first 3 hours post-meal with URLi were comparable to those in healthy subjects.
CONCLUSIONS


URLi demonstrated the fastest insulin absorption and the greatest numeric PPG lowering effect compared to other insulins tested. URLi more closely matched early physiological glucose control observed in healthy subjects. Registered at ClinicalTrials.gov (NCT03449433). This article is protected by copyright. All rights reserved.",2020,URLi achieved the greatest numerical reduction in PPG at 2 hours post-meal (7 mg/dL vs Fiasp) and significant differences to Humalog (21 mg/dL) and Novo Rapid (29 mg/dL).,"['68 patients with T1D. Patients', 'patients with type 1 diabetes (T1D', '12 healthy subjects', 'healthy subjects']","['URLi', 'pharmacokinetics (PK) and glucocodynamics (GD) of URLi, Fiasp®, Humalog®, and NovoRapid®', 'Ultra rapid lispro (URLi']","['Ultra Rapid Lispro Lowers Postprandial Glucose and More Closely Matches Normal Physiological Glucose Response', 'insulin absorption', 'maximal drug concentration', 'glucose excursions', 'postprandial glucose (PPG) control', 'late insulin exposure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4529885', 'cui_str': 'Fiasp'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0939412', 'cui_str': 'NovoRapid'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",68.0,0.0670366,URLi achieved the greatest numerical reduction in PPG at 2 hours post-meal (7 mg/dL vs Fiasp) and significant differences to Humalog (21 mg/dL) and Novo Rapid (29 mg/dL).,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Coutant', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LaBell', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kapitza', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bue-Valleskey', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'Qianyi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leohr', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14094']
2868,32436655,"Novel, digital, chest drainage system in cardiac surgery.","BACKGROUND


A new, self-contained, digital, continuous pump-driven chest drainage system is compared in a randomized control trial to a traditional wall-suction system in cardiac surgery.
METHODS


One hundred and twenty adult elective cardiac patients undergoing coronary artery bypass graft and/or valve surgery were randomized to the study or control group. Both groups had similar pre/intra-operative demographics: age 67.8 vs 67.0 years, Euroscore 2.3 vs 2.2, and body surface area 1.92 vs 1.91 m 2  . Additionally, a satisfaction assessment score (0-10) was performed by 52 staff members.
RESULTS


Given homogenous intra-operative variables, total chest-tube drainage was comparable among groups (566 vs 640 mL; ns), but the study group showed more efficient fluid collection during the early postoperative phase due to continuous suction (P = .01). Blood, cell saver transfusions and postoperative hemoglobin values were similar in both groups. The study group experienced drain removal after 29.8 vs 38.4 hours in the control group (ns). Seven crossovers from the Study to the Control group were registered but no patient had drain-related complications. The Personnel Satisfaction Assessment scored above 5 for all questions asked.
CONCLUSIONS


The new, digital, chest drainage system showed better early drainage of the chest cavity and was as reliable as conventional systems. Quicker drain removal might impact on intensive care unit (ICU) stay and reduce costs. Additional advantages are portable size, battery operation, patient mobility, noiseless function, digital indications and alarms. The satisfaction assessment of the new system by the staff revealed a higher score when compared to the traditional wall suction chest drainage system.",2020,"The new, digital, chest drainage system showed better early drainage of the chest cavity and was as reliable as conventional systems.","['Both groups had similar pre/intra-operative demographics: age 67.8 vs 67.0 years, Euroscore 2.3 vs 2.2, and body surface area 1.92 vs 1.91 m 2  ', 'and/or valve surgery', 'One hundred and twenty adult elective cardiac patients undergoing', 'cardiac surgery']",['coronary artery bypass graft'],"['drain-related complications', 'drain removal', 'Blood, cell saver transfusions and postoperative hemoglobin values', 'total chest-tube drainage', 'intensive care unit (ICU) stay and reduce costs', 'satisfaction assessment score', 'efficient fluid collection']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]",120.0,0.0347734,"The new, digital, chest drainage system showed better early drainage of the chest cavity and was as reliable as conventional systems.","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Barozzi', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}, {'ForeName': 'Livio San', 'Initials': 'LS', 'LastName': 'Biagio', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Meneguzzi', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}, {'ForeName': 'Delphine S', 'Initials': 'DS', 'LastName': 'Courvoisier', 'Affiliation': 'Quality of Care Unit, University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Beat H', 'Initials': 'BH', 'LastName': 'Walpoth', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Faggian', 'Affiliation': 'Division of Cardiac Surgery, University of Verona, Verona, Italy.'}]",Journal of cardiac surgery,['10.1111/jocs.14629']
2869,32436796,Evaluation of various carbon dioxide laser settings on the time and number of laser beam passes required to make a full-thickness skin incision and amount of laser-induced tissue artifact.,"OBJECTIVE


To evaluate the time and number of laser beam passes required to make full-thickness skin incisions and extent of laser-induced tissue artifacts following use of a CO 2  laser at various settings.
SAMPLE


24 skin specimens from six 5-month-old porcine carcasses.
PROCEDURES


4 full-thickness skin specimens were harvested from the flank regions of each carcass within 30 minutes after euthanasia and randomly assigned to 4 treatment groups. Three 5-cm-long incisions were made in each specimen with a CO 2  laser (beam diameter, 0.4 mm) set to deliver a continuous wave of energy alone (groups 1 and 2) or in superpulse mode (groups 3 and 4) at 10 (groups 1 and 3) or 20 (groups 2 and 4) W of power. The time and number of passes required to achieve a full-thickness incision were recorded, and extent of laser-induced tissue artifact (as determined by histologic evaluation) was compared among the 4 groups.
RESULTS


Mean time required to make a full-thickness skin incision for groups 2 and 4 (power, 20 W) was significantly less than that for groups 1 and 3 (power, 10 W). Mean number of passes was lowest for group 2 (continuous wave at 20 W). Extent of laser-induced tissue artifact was greatest for group 4 (superpulse mode at 20 W).
CONCLUSIONS AND CLINICAL RELEVANCE


Results provided preliminary information regarding use of CO 2  lasers to make skin incisions in veterinary patients. In vivo studies are necessary to evaluate the effect of various CO 2  laser settings on tissue healing and patient outcome.",2020,"Extent of laser-induced tissue artifact was greatest for group 4 (superpulse mode at 20 W).
","['SAMPLE\n\n\n24 skin specimens from six 5-month-old porcine carcasses', 'veterinary patients']",['various carbon dioxide laser settings'],"['Mean number of passes', 'tissue artifact', 'time and number of passes required to achieve a full-thickness incision', 'Mean time required to make a full-thickness skin incision']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}]",,0.0146509,"Extent of laser-induced tissue artifact was greatest for group 4 (superpulse mode at 20 W).
","[{'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Agulian', 'Affiliation': ''}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Mann', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Middleton', 'Affiliation': ''}, {'ForeName': 'Dae Y', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': ''}]",American journal of veterinary research,['10.2460/ajvr.81.6.514']
2870,32436905,Comparative evaluation of occlusal pits and fissures morphology modification techniques before application of sealants: An  In vitro  study.,"Background


Pits and Fissures are recognized as being highly susceptible to caries. Pit and fissure sealants are one of the best methods of preventing caries as it occludes the fissures and pits from the accumulation of plaque and cariogenic microflora. There are different methods of cleaning and preparing occlusal pits and fissures for preventing caries which helps in alleviating oral health status of paediatric population.
Aim


The aim of the present study was to evaluate and compare the microleakage of pit and fissure sealants after using five different preparation techniques, namely: A) Conventional technique using pumice prophylaxis, B) enameloplasty with round carbide bur, C) enameloplasty with fissurotomy bur, D) air polisher, and E) air abrasion.
Materials and Methods


The study was conducted on 50 caries-free premolars extracted for orthodontic purpose. These teeth were randomly assigned to five groups, 10 teeth in each for receiving fissure sealant after different surface preparation; thermocycling and sectioning of samples were performed and microleakage was assessed under a stereomicroscope after methylene blue dye immersion.
Results


The results of air abrasion groups were significantly superior with ""0"" microleakage when compared to all other groups followed by round bur, fissurotomy bur, air polisher and pumice prophylaxis.
Conclusion


To improve the marginal adaptation of the sealants, minimally invasive methods are the most favoured methods of occlusal preparation. This study promises to show positive results for fissure sealants which are likely to play an important role in caries prevention and techniques that are intended to protect caries susceptible surfaces.",2020,"The results of air abrasion groups were significantly superior with ""0"" microleakage when compared to all other groups followed by round bur, fissurotomy bur, air polisher and pumice prophylaxis.
",['50 caries-free premolars extracted for orthodontic purpose'],"['Conventional technique using pumice prophylaxis, B) enameloplasty with round carbide bur, C) enameloplasty with fissurotomy bur, D) air polisher, and E) air abrasion', 'fissure sealant after different surface preparation; thermocycling and sectioning of samples were performed and microleakage was assessed under a stereomicroscope after methylene blue dye immersion']",['microleakage of pit and fissure sealants'],"[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0072604', 'cui_str': 'pumice'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0016168', 'cui_str': 'Fissure Sealants'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0031992', 'cui_str': 'Pit Fissure Sealants'}]",50.0,0.0450896,"The results of air abrasion groups were significantly superior with ""0"" microleakage when compared to all other groups followed by round bur, fissurotomy bur, air polisher and pumice prophylaxis.
","[{'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Dentistry, Nalanda Medical College and Hospital, Patna, Bihar, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Patna Dental College and Hospital, Patna, Bihar, India.'}, {'ForeName': 'Vishwas', 'Initials': 'V', 'LastName': 'Patil', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil University (DPU)), Pune, Maharashtra, India.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Juyal', 'Affiliation': 'MDS, (Paediatric and Preventive Dentistry), Consultant, Cloud 32 Dental Clinic, Pune, Maharashtra, India.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Raj', 'Affiliation': 'Department of Public Health Dentistry, Patna Dental College and Hospital, Patna, Bihar, India.'}, {'ForeName': 'Priyadershini', 'Initials': 'P', 'LastName': 'Rangari', 'Affiliation': 'Department of Dentistry, Sri Shankaracharya Institute of Medical Sciences, Bhilai, Durg, Chhattisgarh, India.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_956_19']
2871,32436683,COPD exacerbation costs in the IMPACT study: a within-trial analysis.,"OBJECTIVES


Exacerbations account for the greatest proportion of costs associated with chronic obstructive pulmonary disease (COPD). Here we aimed to evaluate, from the US payer perspective, the costs associated with moderate and severe COPD exacerbation events for patients treated with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) compared with FF/VI or UMEC/VI.
STUDY DESIGN


This post hoc, within-trial economic analysis used data derived from the InforMing the PAthway of COPD Treatment (IMPACT) study (NCT02164513).
METHODS


Treatment groups within the IMPACT trial received either triple therapy with FF/UMEC/VI (100/62.5/25 mcg) or dual therapy (FF/VI [100/25 mcg] or UMEC/VI [62.5/25 mcg]). The primary end point for this IMPACT post hoc analysis was cost differences between the treatment arms related to 1-year on-treatment combined moderate and severe COPD exacerbation events.
RESULTS


The final study sample for this within-trial analysis consisted of 10,355 patients, 49% of whom experienced an on-treatment moderate or severe exacerbation during the study. The mean 1-year on-treatment cost estimate associated with combined moderate and severe exacerbations was highest with UMEC/VI and lowest with FF/UMEC/VI ($6205 vs $4913, respectively). Mean cost differences were statistically significant for all pairwise comparisons of FF/UMEC/VI with FF/VI or UMEC/VI (-$549 [95% CI, -$565 to -$533] and -$1292 [95% CI, -$1313 to -$1272], respectively; both P <.0001).
CONCLUSIONS


Treatment with FF/UMEC/VI compared with FF/VI or UMEC/VI in the US healthcare system resulted in lower exacerbation-related costs for combined moderate/severe exacerbation events, as well as moderate and severe exacerbations separately.",2020,Mean cost differences were statistically significant for all pairwise comparisons of FF/UMEC/VI with FF/VI or UMEC/VI (,"['10,355 patients, 49% of whom experienced an on-treatment moderate or severe exacerbation during the study', '549', 'chronic obstructive pulmonary disease (COPD']","['FF/VI or UMEC/VI', 'fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI', 'triple therapy with FF/UMEC/VI (100/62.5/25 mcg) or dual therapy (FF/VI [100/25 mcg] or UMEC']","['severe exacerbations', 'Mean cost differences', 'COPD exacerbation costs', '1-year on-treatment combined moderate and severe COPD exacerbation events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",10355.0,0.527849,Mean cost differences were statistically significant for all pairwise comparisons of FF/UMEC/VI with FF/VI or UMEC/VI (,"[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Bogart', 'Affiliation': 'US Value Evidence and Outcomes, GlaxoSmithKline plc, 5 Moore Dr, Research Triangle Park, Durham, NC. Email: michael.r.bogart@gsk.com.'}, {'ForeName': 'Sari D', 'Initials': 'SD', 'LastName': 'Hopson', 'Affiliation': ''}, {'ForeName': 'Huai-Che', 'Initials': 'HC', 'LastName': 'Shih', 'Affiliation': ''}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Stanford', 'Affiliation': ''}, {'ForeName': 'Anna D', 'Initials': 'AD', 'LastName': 'Coutinho', 'Affiliation': ''}]",The American journal of managed care,['10.37765/ajmc.2020.43157']
2872,32436724,Evaluation of a brief interval exercise training (IET) intervention for first-time prisoners with elevated anxiety symptoms.,"ABSTRACT Background:  Exercise training has a history of alleviating anxiety in various populations, but research into its effects on prison inmates is limited. Confinement to prison is a highly distressing event for those who have never experienced incarceration, which can dramatically increase anxiety-related symptoms and may exacerbate suicidal risk. Methods:  Thirty-seven first-time prisoners with elevated anxiety symptoms completed the State-Trait Anxiety Inventory before and after a 6-week long treatment period consisting of interval exercise training (IET;  n  = 20) or no intervention (waiting-list;  n  = 17). Prisoners in the IET intervention had to exercise three times per week (40 min per session) under the supervision of the first and/or second author. Exercise intensity was self-monitored using the Borg's RPE-15 scale, with targets in the range 13-15 (""somewhat hard""-""hard""). Results:  Those who received the IET intervention showed a significantly greater reduction in anxiety than prisoners in the waiting-list. The effect size for IET was of moderate-to-large magnitude (Cohen's  d  = -0.71). Conclusion:  The authors conclude that the lower levels of anxiety reported following IET suggest that supervised exercise training is an effective coping strategy to deal with incarceration. Trial registration:  ClinicalTrials.gov identifier: NCT04019171.",2020,showed a significantly greater reduction in anxiety than prisoners in the waiting-list.,"['Thirty-seven first-time prisoners with elevated anxiety symptoms completed the State-Trait Anxiety Inventory before and after a 6-week long treatment period consisting of', 'first-time prisoners with elevated anxiety symptoms']","['IET intervention', 'brief interval exercise training (IET) intervention', 'Exercise training', 'supervised exercise training', 'interval exercise training (IET;  n \u2009=\u200920) or no intervention (waiting-list;  n \u2009=\u200917']",['anxiety'],"[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0491,showed a significantly greater reduction in anxiety than prisoners in the waiting-list.,"[{'ForeName': 'Fabien D', 'Initials': 'FD', 'LastName': 'Legrand', 'Affiliation': 'Department of Psychology, C2S, EA 6291, Université de Reims Champagne Ardenne, Reims, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Ory', 'Affiliation': 'Department of Psychology, C2S, EA 6291, Université de Reims Champagne Ardenne, Reims, France.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Herring', 'Affiliation': 'Department of Physical Education and Sports Sciences, Health Research Institute, University of Limerick, Limerick, Ireland.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1768244']
2873,32436906,Estimation of salivary calcium level as a screening tool for the osteoporosis in the post-menopausal women: A prospective study.,"Aims and Objectives


The aim and objective of the present study was to explore the use of salivary calcium levels as a diagnostic biochemical marker for osteoporosis in menopausal women and also to find the correlation among oestrogen level, bone density and salivary calcium level.
Materials and Methods


The study included 180 individuals and they were divided into three groups with 60 individuals in each group, comprised of healthy women, pregnant women and post-menopausal women. All the women were asked to collect at least 2 ml of unstimulated whole saliva in the sterile plastic sample containers. The samples were immediately subjected to biochemical estimation of calcium. Similarly, estimation was done for oestrogen level and bone density among all the groups. The results were obtained by one-way analysis of variance (ANOVA) using Statistical Software SPSS version 17. For the correlation among the bone density, salivary calcium level and serum oestrogen levels, Pearson's correlation was used.
Results


The mean salivary calcium level in the healthy women group was found to be 3.0 ± 0.50 μg/ml. Similarly, pregnant women and post-menopausal group, it was found to be 3.20 ± 0.72 and 7.5 ± 0.90 μg/ml, respectively. When the intergroup comparison was done in the three groups, it was found to be highly significant (P = 0.001). Similarly, the difference in mean value for oestrogen level and bone density was highly significant among all the groups (P = 0.001).
Conclusion


Among all the three groups, the salivary calcium levels do exhibit the correlation with bone mineral density. In the post-menopausal group, there was significant increase in salivary calcium level compared to other groups. Similarly, the study showed a negative correlation between salivary calcium and serum oestrogen. This substantiates the point that salivary calcium levels can definitely indicate the possibility of the presence or absence of osteoporosis in post-menopausal women.",2020,"When the intergroup comparison was done in the three groups, it was found to be highly significant (P = 0.001).","['osteoporosis in the post-menopausal women', '180 individuals and they were divided into three groups with 60 individuals in each group, comprised of healthy women, pregnant women and post-menopausal women', 'osteoporosis in menopausal women']",[],"['bone density, salivary calcium level and serum oestrogen levels', 'mean salivary calcium level', 'salivary calcium and serum oestrogen', 'mean value for oestrogen level and bone density', 'oestrogen level, bone density and salivary calcium level', 'oestrogen level and bone density', 'salivary calcium levels', 'salivary calcium level']","[{'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],"[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0857965', 'cui_str': 'Serum oestrogen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}]",180.0,0.0287424,"When the intergroup comparison was done in the three groups, it was found to be highly significant (P = 0.001).","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Wasti', 'Affiliation': 'Department of Oral Pathology, Government Dental College and Hospital, Raipur, Chhattishagrh, India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Wasti', 'Affiliation': 'Department of Periodontology, Government Dental College and Hospital, Raipur, Chhattishagrh, India.'}, {'ForeName': 'Ritunja', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Periodontology, New Horizon Dental College, Bilaspur, Chhattishagrh, India.'}]",Indian journal of dental research : official publication of Indian Society for Dental Research,['10.4103/ijdr.IJDR_879_19']
2874,14722635,Effects of protective and conventional mechanical ventilation on pulmonary function and systemic cytokine release after cardiopulmonary bypass.,"OBJECTIVE


To evaluate the effects of protective and conventional ventilation with or without positive end-expiratory pressure (PEEP), on systemic tumor necrosis factor-alpha, interleukin-6 levels and pulmonary function during open heart surgery.
DESIGN


Prospective, randomized clinical study.
SETTING


Single university hospital.
PATIENTS AND PARTICIPANTS


Forty-four patients undergoing elective coronary artery bypass grafting surgery with cardiopulmonary bypass.
INTERVENTIONS


Patients ventilated with (1) protective tidal volumes (6 ml/kg, respiratory rate: 15 breaths/min, PEEP 5 cmH(2)O, n=15) group PV; (2) conventional tidal volumes (10 ml/kg, respiratory rate: 9 breaths/min, PEEP 5 cmH(2)O, n=14) group CV+PEEP and (3) conventional tidal volumes (10 ml/kg, respiratory rate: 9 breaths/min, n=15) without PEEP, group CV+ZEEP. Various pulmonary parameters, systemic TNF-alpha and IL-6 levels were determined throughout the study.
MEASUREMENTS AND RESULTS


There were no differences among the groups regarding the systemic TNF- alpha and IL-6 levels. The plateau airway pressures of group PV were lower than those of groups CV+PEEP ( p=0.02) and CV+ZEEP ( p=0.001) after cardiopulmonary bypass. The shunt fraction of group PV was significantly lower than that of group CV+ZEEP 24 h after surgery ( p<0.05). Oxygenation and the alveolar-arterial oxygen difference were better in both PEEP groups than in group CV+ZEEP 24 h after the operation.
CONCLUSIONS


We could not find any evidence that protective mechanical ventilation prevents some of the adverse effects of cardiopulmonary bypass on the lung, nor systemic cytokine levels, postoperative pulmonary function or length of hospitalization.",2004,"Oxygenation and the alveolar-arterial oxygen difference were better in both PEEP groups than in group CV+ZEEP 24 h after the operation.
","['Forty-four patients undergoing elective coronary artery bypass grafting surgery with cardiopulmonary bypass', 'cardiopulmonary bypass', 'Single university hospital']","['protective and conventional ventilation with or without positive end-expiratory pressure (PEEP', 'Patients ventilated with (1) protective tidal volumes (6 ml/kg, respiratory rate: 15 breaths/min, PEEP 5 cmH(2)O, n=15) group PV; (2) conventional tidal volumes (10 ml/kg, respiratory rate: 9 breaths/min, PEEP 5 cmH(2)O, n=14) group CV+PEEP and (3) conventional tidal volumes', 'PEEP, group CV+ZEEP', 'CV+ZEEP', 'protective and conventional mechanical ventilation']","['plateau airway pressures of group PV', 'systemic cytokine levels, postoperative pulmonary function or length of hospitalization', 'Various pulmonary parameters, systemic TNF-alpha and IL-6 levels', 'systemic tumor necrosis factor-alpha, interleukin-6 levels and pulmonary function', 'Oxygenation and the alveolar-arterial oxygen difference', 'shunt fraction of group PV', 'systemic TNF- alpha and IL-6 levels', 'pulmonary function and systemic cytokine release']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0439386', 'cui_str': 'breaths per minute'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1442858', 'cui_str': 'Surgical fistula'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",44.0,0.0628238,"Oxygenation and the alveolar-arterial oxygen difference were better in both PEEP groups than in group CV+ZEEP 24 h after the operation.
","[{'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Koner', 'Affiliation': 'Anesthesiology Department, Cardiology Institute, Istanbul University, Haseki caddesi, 34303, Aksaray-Istanbul, Turkey, alikoner@superonline.com'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Celebi', 'Affiliation': ''}, {'ForeName': 'Huriye', 'Initials': 'H', 'LastName': 'Balci', 'Affiliation': ''}, {'ForeName': 'Gurkan', 'Initials': 'G', 'LastName': 'Cetin', 'Affiliation': ''}, {'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Karaoglu', 'Affiliation': ''}, {'ForeName': 'Nahit', 'Initials': 'N', 'LastName': 'Cakar', 'Affiliation': ''}]",Intensive care medicine,[]
2875,31503408,A texting-based blood pressure surveillance intervention.,"The authors examined whether using home BP measurements collected via a custom-built bi-directional-texting platform incorporated into patients' electronic medical records would lead to treatment calibration and improved BP management. Patients were randomized to either the intervention group and collected home measurements based on reminders and reported via bi-directional texting, or to the control group, with home BP measurement reporting via standard practice (eg, phone, electronic medical record portal) and instructed to return 7 morning and 7 evening BP measurements. Outcomes included number of BP measurements submitted, the number of medication changes, reduction in BP, and BP control. 72% of the intervention group submitted at least 14 readings, compared with 45% of the control group. BP control improved in both groups. However, the authors found no statistically significant difference in BP or the number of BP-medication changes at 1, 3, or 6 months compared with the control group.",2019,BP control improved in both groups.,[],"['intervention group and collected home measurements based on reminders and reported via bi-directional texting, or to the control group, with home BP measurement reporting via standard practice (eg, phone, electronic medical record portal) and instructed to return 7 morning and 7 evening BP measurements', 'A texting-based blood pressure surveillance intervention']","['number of BP measurements submitted, the number of medication changes, reduction in BP, and BP control', 'BP or the number of BP-medication changes', 'BP control']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",7.0,0.0398183,BP control improved in both groups.,"[{'ForeName': 'Roula S', 'Initials': 'RS', 'LastName': 'Zahr', 'Affiliation': 'Department of Internal Medicine, Oregon Health Sciences University, Portland, OR, USA.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Anthony', 'Affiliation': 'Department of Orthopaedic Surgery, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Polgreen', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Simmering', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Goerdt', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Angela B', 'Initials': 'AB', 'LastName': 'Hoth', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Miller', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Suneja', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Segre', 'Affiliation': 'Department of Computer Science, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Carter', 'Affiliation': 'Department of Pharmacy Practice and Science, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Cavanaugh', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Linnea A', 'Initials': 'LA', 'LastName': 'Polgreen', 'Affiliation': 'Department of Pharmacy Practice and Science, University of Iowa, Iowa City, IA, USA.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13674']
2876,31371130,Combined exercise and visual gaze training improves stepping accuracy in people with diabetic peripheral neuropathy.,"INTRODUCTION


Patients with diabetes and diabetic peripheral neuropathy (DPN) place their feet with less accuracy whilst walking, which may contribute to the increased falls-risk. This study examines the effects of a multi-faceted intervention on stepping accuracy, in patients with diabetes and DPN.
METHODS


Forty participants began the study, of which 29 completed both the pre and post-intervention tests, 8 patients with DPN, 11 patients with diabetes but no neuropathy (D) and 10 healthy controls (C). Accuracy of stepping was measured pre- and post-intervention as participants walked along an irregularly arranged stepping walkway. Participants attended a one-hour session, once a week, for sixteen weeks, involving high-load resistance exercise and visual-motor training.
RESULTS


Patients who took part in the intervention improved stepping accuracy (DPN: +45%; D: +36%) (p < 0.05). The diabetic non-intervention (D-NI) group did not display any significant differences in stepping accuracy pre- to post- the intervention period (-7%).
DISCUSSION


The improved stepping accuracy observed in patients with diabetes and DPN as a result of this novel intervention, may contribute towards reducing falls-risk. This multi-faceted intervention presents promise for improving the general mobility and safety of patients during walking and could be considered for inclusion as part of clinical treatment programmes.",2019,Accuracy of stepping was measured pre- and post-intervention as participants walked along an irregularly arranged stepping walkway.,"['Forty participants began the study, of which 29 completed both the pre and post-intervention tests, 8 patients with DPN, 11 patients with diabetes but no neuropathy (D) and 10 healthy controls (C', 'people with diabetic peripheral neuropathy', 'patients with diabetes and DPN']","['multi-faceted intervention', 'high-load resistance exercise and visual-motor training', 'Combined exercise and visual gaze training']","['stepping accuracy', 'stepping accuracy pre']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",40.0,0.0225618,Accuracy of stepping was measured pre- and post-intervention as participants walked along an irregularly arranged stepping walkway.,"[{'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Handsaker', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Life Sciences, Faculty of Science & Engineering, Manchester Metropolitan University, Oxford Road, Manchester, United Kingdom.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Brown', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Life Sciences, Faculty of Science & Engineering, Manchester Metropolitan University, Oxford Road, Manchester, United Kingdom.'}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Petrovic', 'Affiliation': 'Research Centre for Movement Sciences, Department of Physiotherapy, Faculty of Medicine, University of Iceland, Reykjavik, Iceland. Electronic address: mpetrovic@hi.is.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Bowling', 'Affiliation': 'Faculty of Medical and Human Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Rajbhandari', 'Affiliation': 'Lancashire Teaching Hospitals, Chorley and South Ribble Hospital, United Kingdom.'}, {'ForeName': 'Dilwyn E', 'Initials': 'DE', 'LastName': 'Marple-Horvat', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Life Sciences, Faculty of Science & Engineering, Manchester Metropolitan University, Oxford Road, Manchester, United Kingdom.'}, {'ForeName': 'Andrew J M', 'Initials': 'AJM', 'LastName': 'Boulton', 'Affiliation': 'Faculty of Medical and Human Sciences, University of Manchester, Manchester, United Kingdom; Diabetes Research Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Reeves', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Life Sciences, Faculty of Science & Engineering, Manchester Metropolitan University, Oxford Road, Manchester, United Kingdom.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.07.001']
2877,31447126,Non-typeable Haemophilus influenzae protein vaccine in adults with COPD: A phase 2 clinical trial.,"Loss of airway microbial diversity is associated with non-typeable Haemophilus influenzae (NTHi) infection and increased risk of exacerbation in chronic obstructive pulmonary disease (COPD). We assessed the safety and immunogenicity of an investigational vaccine containing NTHi antigens, recombinant protein D (PD) and combined protein E and Pilin A (PE-PilA), and AS01 adjuvant in adults with moderate/severe COPD and prior exacerbations. In this phase 2, observer-blind, controlled trial (NCT02075541), 145 COPD patients aged 40-80 years randomly (1:1) received two doses of NTHi vaccine or placebo 60 days apart, on top of standard care. Reactogenicity in the 7-day post-vaccination period was higher following NTHi vaccine than placebo. Most solicited adverse events (AEs) were mild/moderate. At least one unsolicited AE was reported during the 30-day post-vaccination period by 54.8% of NTHi vaccine and 51.4% of placebo recipients. One serious AE (placebo group) was assessed by the investigator as vaccine-related. Anti-PD, anti-PE and anti-PilA geometric mean antibody concentrations increased up to 30 days after each NTHi vaccine dose, waned thereafter, but remained higher than baseline (non-overlapping confidence intervals) up to 13 months post-dose 2. The frequency of specific CD4 +  T cells increased following two doses of NTHi vaccine and remained higher than baseline. Exploratory analysis showed a statistically non-significant lower yearly rate of moderate/severe exacerbations in the NTHi vaccine group than following placebo (1.49 versus 1.73) in the one-year period post-dose 2, with estimated vaccine efficacy of 13.3% (95% confidence interval -24.2 to 39.5; p = 0.44). The NTHi vaccine had an acceptable safety and reactogenicity profile and good immunogenicity in adults with COPD.",2019,"Anti-PD, anti-PE and anti-PilA geometric mean antibody concentrations increased up to 30 days after each NTHi vaccine dose, waned thereafter, but remained higher than baseline (non-overlapping confidence intervals) up to 13 months post-dose 2.","['145 COPD patients aged 40-80\u202fyears randomly (1:1', 'adults with COPD', 'chronic obstructive pulmonary disease (COPD', 'adults with moderate/severe COPD and prior exacerbations']","['placebo', 'NTHi vaccine or placebo', 'NTHi vaccine', 'investigational vaccine containing NTHi antigens, recombinant protein D (PD) and combined protein E and Pilin A (PE-PilA), and AS01 adjuvant']","['Anti-PD, anti-PE and anti-PilA geometric mean antibody concentrations', 'frequency of specific CD4 +  T cells', 'yearly rate of moderate/severe exacerbations', 'safety and immunogenicity', 'acceptable safety and reactogenicity profile and good immunogenicity', 'Reactogenicity']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0034861', 'cui_str': 'Biosynthetic Proteins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0071061', 'cui_str': 'Pili Structural Proteins'}, {'cui': 'C0323968', 'cui_str': 'Pila'}, {'cui': 'C3884266', 'cui_str': 'adjuvant system 01'}]","[{'cui': 'C0323968', 'cui_str': 'Pila'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",145.0,0.600523,"Anti-PD, anti-PE and anti-PilA geometric mean antibody concentrations increased up to 30 days after each NTHi vaccine dose, waned thereafter, but remained higher than baseline (non-overlapping confidence intervals) up to 13 months post-dose 2.","[{'ForeName': 'Tom M A', 'Initials': 'TMA', 'LastName': 'Wilkinson', 'Affiliation': 'Clinical and Experimental Sciences, University of Southampton, Faculty of Medicine, Southampton General Hospital, Southampton, UK; Southampton NIHR Respiratory Biomedical Research Unit, Southampton General Hospital, Southampton, UK; Wessex Investigational Sciences Hub, University of Southampton, Faculty of Medicine, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Schembri', 'Affiliation': 'Scottish Centre for Respiratory Research, University of Dundee, Dundee, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Brightling', 'Affiliation': 'Institute for Lung Health, Department of Infection, Immunity and Inflammation, University of Leicester, Leicester, UK.'}, {'ForeName': 'Nawar D', 'Initials': 'ND', 'LastName': 'Bakerly', 'Affiliation': 'Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Keir', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': 'School of Medicine, University of Swansea, Wales, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'MacNee', 'Affiliation': 'MRC Centre for Inflammation Research, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rombo', 'Affiliation': 'Clinical Research Centre, Sormland County Council, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hedner', 'Affiliation': 'Pulmonary Medicine, Department of Internal Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Department of Respiratory Medicine, Royal Stoke Hospital, University Hospitals of North Midlands, Stoke-on-Trent, UK.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Walker', 'Affiliation': 'Department of Respiratory Medicine, Aintree University Hospital, Liverpool, UK.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Ryck', 'Affiliation': 'GSK, Siena, Italy.'}, {'ForeName': 'Annaelisa', 'Initials': 'A', 'LastName': 'Tasciotti', 'Affiliation': 'GSK, Siena, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Casula', 'Affiliation': 'GSK, Siena, Italy.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moris', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Testa', 'Affiliation': 'GSK, Siena, Italy. Electronic address: marco.x.testa@gsk.com.'}, {'ForeName': 'Ashwani K', 'Initials': 'AK', 'LastName': 'Arora', 'Affiliation': 'GSK, Siena, Italy.'}]",Vaccine,['10.1016/j.vaccine.2019.07.100']
2878,20360151,A randomized controlled trial of a wellness intervention for women with fibromyalgia syndrome.,"OBJECTIVE


To examine the effects of a wellness intervention, Lifestyle Counts, for women with fibromyalgia syndrome on the level of self-efficacy for health-promoting behaviours, health-promoting activity and perceived quality of life.
DESIGN


A randomized controlled single-blinded trial with treatment and attention-control groups.
SETTING


Community in the southwestern United States.
SUBJECTS


Convenience sample of 187 women (98 treatment, 89 attention control) with fibromyalgia syndrome (mean age = 53.08 years, SD 9.86).
INTERVENTION


The two-phase Lifestyle Counts intervention programme included lifestyle change classes for eight weeks, with goal-setting and telephone follow-up for three months. Participants in the attention-control group were offered an equivalent amount of contact in classes on general disease-related information and health education topics and unstructured follow-up phone calls. Participants were followed for a total of eight months after baseline.
OUTCOME MEASURES


Self-report instruments measuring self-efficacy for health behaviours, health-promotion behaviours and health-related quality of life (SF-36 and the Fibromyalgia Impact Questionnaire) were completed at baseline, two months (after the classes), five months (after telephone follow-up) and at eight months.
RESULTS


Both groups improved significantly (P<0.05) over time on the measures of self-efficacy, health behaviours, fibromyalgia impact and quality of life. There were significant group x time interactions for scores on the Health Promoting Lifestyle II subscales of physical activity and stress management.
CONCLUSIONS


The Lifestyle Counts wellness intervention holds promise for improving health-promoting behaviours and quality of life of women with fibromyalgia syndrome.",2010,"Both groups improved significantly (P<0.05) over time on the measures of self-efficacy, health behaviours, fibromyalgia impact and quality of life.","['Convenience sample of 187 women (98 treatment, 89 attention control) with fibromyalgia syndrome (mean age = 53.08 years, SD 9.86', 'Community in the southwestern United States', 'women with fibromyalgia syndrome']","['wellness intervention', 'Lifestyle Counts wellness intervention', 'equivalent amount of contact in classes on general disease-related information and health education topics and unstructured follow-up phone calls', 'wellness intervention, Lifestyle Counts']","['self-efficacy, health behaviours, fibromyalgia impact and quality of life', 'Health Promoting Lifestyle II subscales of physical activity and stress management', 'Self-report instruments measuring self-efficacy for health behaviours, health-promotion behaviours and health-related quality of life (SF-36 and the Fibromyalgia Impact Questionnaire']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018701'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",187.0,0.095752,"Both groups improved significantly (P<0.05) over time on the measures of self-efficacy, health behaviours, fibromyalgia impact and quality of life.","[{'ForeName': 'Alexa K', 'Initials': 'AK', 'LastName': 'Stuifbergen', 'Affiliation': 'School of Nursing, The University of Texas at Austin, Austin, TX 78701, USA. astuifbergen@mail.utexas.edu'}, {'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Blozis', 'Affiliation': ''}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': ''}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Phillips', 'Affiliation': ''}, {'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'Timmerman', 'Affiliation': ''}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Kullberg', 'Affiliation': ''}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Taxis', 'Affiliation': ''}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': ''}]",Clinical rehabilitation,['10.1177/0269215509343247']
2879,32432914,Effect of 8 days of exercise-heat acclimation on aerobic exercise performance of men in hypobaric hypoxia.,"Exercise-heat acclimation (EHA) induces adaptations that improves tolerance to heat exposure. Whether adaptations from EHA can also alter responses to hypobaric hypoxia (HH) conditions remains unclear. This study assessed whether EHA can alter time-trial performance and/or incidence of acute mountain sickness (AMS) during HH exposure. Thirteen sea level (SL) resident men (SL VO 2 peak: 3.19 ± 0.43 l·min -1 ) completed steady-state exercise followed by a 15-min cycle time-trial and assessment of AMS before (HH1; 3,500 m) and after (HH2) an 8-day EHA protocol (120 min; 5 km·hr -1 ; 2% incline; 40°C and 40% RH). EHA induced lower heart rate (HR) and core temperature, and plasma volume expansion. Time-trial performance was not different between HH1 and HH2 after 2-hr(106.3±23.8 vs 101.4±23.0 kJ, p =0.71) or 24-hrs (107.3±23.4 vs 106.3±20.8 kJ, p>0.9). From HH1 to HH2, HR and oxygen saturation at the end of steady-state exercise and time-trial tests at 2 and 24-hrs was not different (p>0.05). Three of 13 volunteers developed AMS during HH1 but not during HH2, while a fourth volunteer only developed AMS during HH2. Heat shock protein 70 was not different from HH1 to HH2 at SL (1.9±0.7 vs 1.8±0.6 NII, p=0.97) or after 23-hrs (1.8±0.4 vs 1.7±0.5 NII, p=0.78) at HH. Our results indicate that this EHA protocol had little to no effect - neither beneficial nor detrimental - on exercise performance in HH. EHA may reduce AMS in those who initially developed AMS, however, studies at higher elevations having higher incidence rates are needed to confirm our findings.",2020,"Heat shock protein 70 was not different from HH1 to HH2 at SL (1.9±0.7 vs 1.8±0.6 NII, p=0.97) or after 23-hrs (1.8±0.4 vs 1.7±0.5 NII, p=0.78) at HH.","['Thirteen sea level (SL) resident men (SL VO 2 peak: 3.19 ± 0.43 l·min -1 ) completed', 'men in hypobaric hypoxia', 'acute mountain sickness (AMS) during HH exposure']","['exercise-heat acclimation', 'steady-state exercise', 'EHA', 'Exercise-heat acclimation (EHA']","['aerobic exercise performance', 'AMS', 'HH2, HR and oxygen saturation', 'lower heart rate (HR) and core temperature, and plasma volume expansion', 'Time-trial performance', 'exercise performance']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C1563720', 'cui_str': 'Autosomal Dominant Form of Kallmann Syndrome'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0298767,"Heat shock protein 70 was not different from HH1 to HH2 at SL (1.9±0.7 vs 1.8±0.6 NII, p=0.97) or after 23-hrs (1.8±0.4 vs 1.7±0.5 NII, p=0.78) at HH.","[{'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Salgado', 'Affiliation': 'Thermal and Mountain Medicine Division, US Army Research Institute of Environmental Medicine, United States.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Coffman', 'Affiliation': 'Thermal and Mountain Medicine Division, USARIEM, United States.'}, {'ForeName': 'Karleigh E', 'Initials': 'KE', 'LastName': 'Bradbury', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, United States.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Mitchell', 'Affiliation': 'US Army Research Institute of Environmental Medicine, United States.'}, {'ForeName': 'Beau R', 'Initials': 'BR', 'LastName': 'Yurkevicius', 'Affiliation': 'US Army Research Institute of Environmental Medicine, United States.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Luippold', 'Affiliation': 'Thermal and Mountain Medicine Division, USARIEM, United States.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Mayer', 'Affiliation': 'US Army Research Institute of Environmental Medicine, United States.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Charkoudian', 'Affiliation': 'Thermal and Mountain Medicine Division, USARIEM, United States.'}, {'ForeName': 'Billie K', 'Initials': 'BK', 'LastName': 'Alba', 'Affiliation': 'USARIEM, United States.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fulco', 'Affiliation': 'Thermal and Mountain Medicine Division, USARIEM, United States.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Kenefick', 'Affiliation': 'US Army Research Institute of Environmental Medicine, United States.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00048.2020']
2880,32432990,Mindfulness-based strengths practice improves well-being and retention in undergraduates: a preliminary randomized controlled trial.,"Objective:  With high rates of mental health concerns on college campuses, effective positive psychology interventions could greatly improve student well-being and academic outcomes.  Participants:  Working undergraduates (N = 52).  Methods:  This preliminary, randomized controlled trial investigated the effects of the 8-week Mindfulness-based strengths practice (MBSP) on Seligman's five domains of well-being, as measured by the PERMA-Profiler, Workplace PERMA-Profiler, and student retention in working undergraduates.  Results:  Students in the MBSP intervention had significantly higher well-being, engagement, meaning, and health following the MBSP program (P < 0.0042). No such changes were observed in the control group. Students in the intervention group also had modestly higher retention rates in the following academic year than those in the control group.  Conclusions:  This study provides the first evidence to date that an MBSP program can improve college student well-being and retention.",2020,Students in the intervention group also had modestly higher retention rates in the following academic year than those in the control group.  ,"['undergraduates', 'Participants:  Working undergraduates (N\u2009=\u200952']","['8-week Mindfulness-based strengths practice (MBSP', 'Mindfulness-based strengths practice', 'MBSP program']","['retention rates', 'higher well-being, engagement, meaning, and health']","[{'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.0626766,Students in the intervention group also had modestly higher retention rates in the following academic year than those in the control group.  ,"[{'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Wingert', 'Affiliation': 'Department of Health and Wellness, University of North Carolina Asheville, Asheville, North Carolina, USA.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Jones', 'Affiliation': 'Department of Psychology, University of North Carolina Asheville, Asheville, North Carolina, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Swoap', 'Affiliation': 'Department of Psychology, Warren Wilson College, Asheville, North Carolina, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Wingert', 'Affiliation': 'Advancement, Warren Wilson College, Asheville, North Carolina, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2020.1764005']
2881,32437025,Pharmacokinetics and Safety of Ranirestat in Patients With Hepatic Impairment.,"Ranirestat is an aldose reductase inhibitor hypothesized to improve diabetic neuropathy. An open-label, single-dose, parallel-group study was conducted to compare pharmacokinetic (PK) characteristics of an oral dose of ranirestat across subjects with normal hepatic function and patients with mild and moderate hepatic impairment because ranirestat is expected to be used by patients with diabetes mellitus, possibly including those with hepatic impairment. To evaluate the necessity for dose adjustment, PK profiles and tolerability were studied at the dose of 40 mg, the expected optimal clinical dose in patients with diabetic neuropathy and normal hepatic function. In total, 20 subjects, including 5, 10, and 5 subjects with normal hepatic function, mild hepatic impairment, and moderate hepatic impairment, respectively, completed the study. Serial PK sampling was conducted up to 504 hours, and PK parameters were calculated and compared between healthy subjects and patients with mild or moderate hepatic impairment. The geometric mean ratios of peak concentration and area under the concentration-time curve in patients with mild hepatic impairment (90%CI) were 86.7% (55.3% to 135.9%) and 84.7% (68.5% to 104.8%), respectively. The values in patients with moderate hepatic impairment were 81.3% (48.8% to 135.5%) and 91.7% (72.1% to 116.7%), respectively. These results demonstrated that plasma ranirestat exposure and the plasma protein binding of the drug were not substantially altered by normal, mild, or moderate hepatic impairment (protein binding 99.22%, 99.29%, and 99.00%, respectively). All adverse events were mild in severity. Based on these findings, no dose adjustment will be required for ranirestat in patients with mild or moderate hepatic impairment.",2020,All adverse events were mild in severity.,"['In total, 20 subjects, including 5, 10, and 5 subjects with normal hepatic function, mild hepatic impairment, and moderate hepatic impairment, respectively, completed the study', 'healthy subjects and patients with mild or moderate hepatic impairment', 'patients with mild or moderate hepatic impairment', 'patients with diabetes mellitus, possibly including those with hepatic impairment', 'across subjects with normal hepatic function and patients with mild and moderate hepatic impairment because ranirestat', 'patients with diabetic neuropathy and normal hepatic function', 'Patients With Hepatic Impairment']",['ranirestat'],"['moderate hepatic impairment', 'plasma ranirestat exposure and the plasma protein binding', 'geometric mean ratios of peak concentration and area under the concentration-time curve']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis'}, {'cui': 'C3266874', 'cui_str': 'ranirestat'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}]","[{'cui': 'C3266874', 'cui_str': 'ranirestat'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3266874', 'cui_str': 'ranirestat'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",20.0,0.0316012,All adverse events were mild in severity.,"[{'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Itou', 'Affiliation': 'JSDF Hanshin Hospital, Hyogo, Japan.'}, {'ForeName': 'Tomoe', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Pharmacology and Toxicology, Dokkyo Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Division of Gastroenterology, Showa University Fujigaoka Hospital, Kanagawa, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Uchida', 'Affiliation': 'Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Takagaki', 'Affiliation': 'Clinical Pharmacology Group, Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co, Ltd, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ishii', 'Affiliation': 'Group I, Oncology Clinical Development Unit, Sumitomo Dainippon Pharma Co, Ltd, Tokyo, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Kakuyama', 'Affiliation': 'Clinical Pharmacology Group, Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co, Ltd, Tokyo, Japan.'}]",Journal of clinical pharmacology,['10.1002/jcph.1636']
2882,31501069,Effect of denture adhesives on oral moisture: A multicenter randomized controlled trial.,"PURPOSE


The purpose of this study was to investigate the effect of denture adhesives on oral moisture in a 10-center parallel randomized clinical trial.
METHODS


Two hundred edentulous subjects wearing complete dentures were allocated into three groups: cream-type adhesive, powder-type adhesive and control groups. The adhesives (and saline solution in the control group) were applied to the mucosal surface of the dentures for 4 days, and baseline data and data after the intervention for eight meals over 4 days were obtained. For the main outcome, oral moisture was measured with a moisture checking device. Secondary outcomes were denture satisfaction, masticatory performance, denture retention, and occlusal force. In addition to between-group and within-group comparisons of oral moisture, investigations for secondary outcomes were undertaken in subgroups classified according to the degree of oral moisture at baseline (normal subgroup and dry mouth subgroup). Intention-to-treat analysis was also performed.
RESULTS


Between-group and within-group comparisons of oral moisture showed no significant differences. The cream-type and powder-type denture adhesives were significantly effective in the dry mouth group for denture satisfaction ratings of ability to masticate, stability, retention, and comfort of mandibular dentures (p<0.05). The masticatory performance and retentive force of the dry mouth denture adhesive using groups were significantly improved after intervention (p<0.05).
CONCLUSIONS


The oral moisture of complete denture wearers was not influenced by the use of denture adhesives. Our findings showed that denture adhesives improved subjective denture satisfaction, masticatory performance, and retention for complete denture patients with oral dryness.",2020,"The masticatory performance and retentive force of the dry mouth denture adhesive using groups were significantly improved after intervention (p<0.05).
",['Two hundred edentulous subjects wearing complete dentures'],"['denture adhesives', 'cream-type adhesive, powder-type adhesive and control groups']","['subjective denture satisfaction, masticatory performance, and retention', 'masticatory performance and retentive force', 'denture satisfaction, masticatory performance, denture retention, and occlusal force', 'oral moisture', 'denture satisfaction ratings of ability to masticate, stability, retention, and comfort of mandibular dentures']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0011455', 'cui_str': 'Denture, Complete'}]","[{'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0011397', 'cui_str': 'Denture Retention'}, {'cui': 'C0005654', 'cui_str': 'Occlusal Force'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",200.0,0.112357,"The masticatory performance and retentive force of the dry mouth denture adhesive using groups were significantly improved after intervention (p<0.05).
","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Nishi', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutics, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima 890-8544, Japan. Electronic address: shar@dent.kagoshima-u.ac.jp.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Nomura', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Prosthodontics and Oral Implantology, School of Dentistry, Iwate Medical University, 19-1 Uchimaru, Morioka 020-8505, Japan. Electronic address: tarou.nmr@gmail.com.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Murakami', 'Affiliation': 'The Japan Denture Care Society, Japan; Denture Prosthodontic Restoration, Advanced Dentistry Center, Kagoshima University Medical and Dental Hospital, Sakuragaoka 8-35-1, Kagoshima 890-8544, Japan. Electronic address: kaku@dent.kagoshima-u.ac.jp.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Kawai', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587, Japan. Electronic address: kawai.yasuhiko@nihon-u.ac.jp.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nishimura', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutics, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima 890-8544, Japan. Electronic address: mnishi@dent.kagoshima-u.ac.jp.'}, {'ForeName': 'Hisatomo', 'Initials': 'H', 'LastName': 'Kondo', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Prosthodontics and Oral Implantology, School of Dentistry, Iwate Medical University, 19-1 Uchimaru, Morioka 020-8505, Japan. Electronic address: hkondo@iwate-med.ac.jp.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'The Japan Denture Care Society, Japan; Division of Aging and Geriatric Dentistry, Tohoku University Graduate School of Dentistry, 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan. Electronic address: y-itoh@dent.tohoku.ac.jp.'}, {'ForeName': 'Akito', 'Initials': 'A', 'LastName': 'Tsuboi', 'Affiliation': 'The Japan Denture Care Society, Japan; Division of Community Oral Health Science, Department of Community Medical Supports, Tohoku Medical Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai 980-8573, Japan. Electronic address: tsuboi@m.tohoku.ac.jp.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': 'The Japan Denture Care Society, Japan; Liaison Center for Innovative Dentistry, Tohoku University Graduate School of Dentistry, 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan. Electronic address: hong@m.tohoku.ac.jp.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Kimoto', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587, Japan. Electronic address: kimoto.suguru@nihon-u.ac.jp.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Gunji', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587, Japan. Electronic address: gunji.atsuko@nihon-u.ac.jp.'}, {'ForeName': 'Asako', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics, Nihon University Graduate School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587, Japan. Electronic address: maas14013@g.nihon-u.ac.jp.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Ohwada', 'Affiliation': 'The Japan Denture Care Society, Japan; Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo 113-8549, Japan. Electronic address: g.ohwada.gerd@tmd.ac.jp.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Minakuchi', 'Affiliation': 'The Japan Denture Care Society, Japan; Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo 113-8549, Japan. Electronic address: s.minakuchi.gerd@tmd.ac.jp.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'The Japan Denture Care Society, Japan; Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo 113-8549, Japan. Electronic address: y.sato.gerd@tmd.ac.jp.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'The Japan Denture Care Society, Japan; Section of Oral Prosthetic Engineering, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo 113-8549, Japan. Electronic address: suzuki.peoe@tmd.ac.jp.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Kimoto', 'Affiliation': 'The Japan Denture Care Society, Japan; Division of Prosthodontics & Oral Implantology, Department of Oral Interdisciplinary Medicine, Graduate School of Dentistry, Kanagawa Dental University, 82 Inaoka-cho, Yokosuka, Kanagawa 238-8580, Japan. Electronic address: k.kimoto@kdu.ac.jp.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Hoshi', 'Affiliation': 'The Japan Denture Care Society, Japan; Division of Prosthodontics & Oral Implantology, Department of Oral Interdisciplinary Medicine, Graduate School of Dentistry, Kanagawa Dental University, 82 Inaoka-cho, Yokosuka, Kanagawa 238-8580, Japan. Electronic address: hoshi@kdu.ac.jp.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Saita', 'Affiliation': 'The Japan Denture Care Society, Japan; Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo 113-8549, Japan. Electronic address: saita@kdu.ac.jp.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Yoneyama', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501, Japan. Electronic address: yoneyama-y@tsurumi-u.ac.jp.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501, Japan. Electronic address: sato-yohei@tsurumi-u.ac.jp.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Morokuma', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501, Japan. Electronic address: info@morokumashika.com.'}, {'ForeName': 'Joji', 'Initials': 'J', 'LastName': 'Okazaki', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics and Occlusion, Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka 540-0008, Japan. Electronic address: joji@cc.osaka-dent.ac.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics and Occlusion, Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka 540-0008, Japan. Electronic address: maeda-t@cc.osaka-dent.ac.jp.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Nakai', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Removable Prosthodontics and Occlusion, Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka 540-0008, Japan. Electronic address: nakai-ks@cc.osaka-dent.ac.jp.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Ichikawa', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima 770-8504, Japan. Electronic address: ichi@tokushima-u.ac.jp.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Nagao', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima 770-8504, Japan. Electronic address: kan@tokushima-u.ac.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima 770-8504, Japan. Electronic address: c301451014@tokushima-u.ac.jp.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Murata', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki 852-8588, Japan. Electronic address: hmurata@nagasaki-u.ac.jp.'}, {'ForeName': 'Tadafumi', 'Initials': 'T', 'LastName': 'Kurogi', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki 852-8588, Japan. Electronic address: kurofumi@nagasaki-u.ac.jp.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'The Japan Denture Care Society, Japan; Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki 852-8588, Japan. Electronic address: kyoshida@nagasaki-u.ac.jp.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Hosoi', 'Affiliation': 'The Japan Denture Care Society, Japan; Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501, Japan. Electronic address: hosoi-t@tsurumi-u.ac.jp.'}, {'ForeName': 'Taizo', 'Initials': 'T', 'LastName': 'Hamada', 'Affiliation': 'The Japan Denture Care Society, Japan; Hiroshima University, 1-2-3 Kasumi, Minamiku, Hiroshima, Hiroshima 734-8553, Japan. Electronic address: thamada66@gmail.com.'}]",Journal of prosthodontic research,['10.1016/j.jpor.2019.08.004']
2883,32433138,Modeling Medical Education: The Impact of Three-Dimensional Printed Models on Medical Student Education in Plastic Surgery.,"PURPOSE


Trainee exposure to craniofacial pathology can be limited due to rare disease presentation, revealing a need for tools that assist in visualizing complex 3D pathologic anatomy. 3D-printed models show potential as a useful aid, allowing for physical manipulation and hands-on experience. This study investigates their educational value in teaching craniofacial pathology and surgical repair.
METHODS


Forty-four medical students randomly assigned to a control group or model group were given a PowerPoint presentation-based module on craniosynostosis and surgical repair. The model group was also provided with 3D-printed models of sagittal, metopic, and bicoronal synostosis, created using patient-specific preoperative computed tomography data. A survey using the Likert scale evaluated participants' learning experience. Pre- and postmodule scores on a 10-question multiple choice quiz were recorded.
RESULTS


The survey showed that students in the model group reported better understanding of the anatomy (4.86 ± 0.15 versus 4.26 ± 0.22; P = 0.0001) and visualization of the pathology (4.76 ± 0.23 versus 4.26 ± 0.25; P = 0.0064), gaining an improved understanding of surgical approach (4.38 ± 0.37 versus 3.83 ± 0.29; P = 0.0266), which was more effectively taught (4.24 ± 0.33 versus 3.30 ± 0.38; P = 0.0007) with the 3D-printed models. The mean pre- and post-module quiz scores between groups were similar.
CONCLUSION


3D-printed models demonstrated an improved learning experience for medical students as shown by survey. These findings suggest a potential use for 3D-printed models in medical education of craniofacial pathology and surgery.",2020,The survey showed that students in the model group reported better understanding of the anatomy (4.86 ± 0.15 versus 4.26 ± 0.22; P = 0.0001) and visualization of the pathology (4.76 ± 0.23 versus 4.26 ± 0.25; P = ,"['Medical Student Education in Plastic Surgery', 'Modeling Medical Education', 'Forty-four medical students']",['control group or model group were given a PowerPoint presentation-based module on craniosynostosis and surgical repair'],"['learning experience', 'mean pre- and post-module quiz scores']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",44.0,0.0201991,The survey showed that students in the model group reported better understanding of the anatomy (4.86 ± 0.15 versus 4.26 ± 0.22; P = 0.0001) and visualization of the pathology (4.76 ± 0.23 versus 4.26 ± 0.25; P = ,"[{'ForeName': 'Jaina C', 'Initials': 'JC', 'LastName': 'Lane', 'Affiliation': 'Department of Plastic Surgery, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Black', 'Affiliation': ''}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006567']
2884,32436985,The healing effects of Hyperium perforatum (St. John's Wort) on experimental alkaline corrosive eosephageal and stomach burns.,"BACKGROUND


The most frequent etiologic cause is alkaline substances. We investigated the protective effects of the plant St. John 's Wort (Hypericum perforatum).
METHODS


We included 42 Wistar albino rats weighing between 200-300 grams and divided into six groups as Group 1: Control, Group 2: Burn+Saline (BS), Group 3: Burn+St. John's Wort (BSJW), Group 4: Burn+Plasebo (BP), Group 5: St. John's Wort (SJW), Group 6: Placebo (P). After 15 days of treatment, esophagus, stomach and liver tissue samples were derived by dissection for histopathologic and biochemical markers. The cytotoxic effects of formulation on fibroblasts is evaluated in vitro on human dermoblast fibroblast line (HDFa, Gibco Invitrogen cell culture, C-013-5C).
RESULTS


The weight of the rats increased in Group 1, 3, 4, 6, decreased in Group 2 and did not change in Group 5. In the BSJW group, submucosal collagen accumulation, muscularis mucosa damage, tunica muscularis damage and collagen accumulation in esophagus were similar to the control group but lesser than BS and placebo group. In the stomach, mucosal damage, gastric gland dilatation, submucosal polymorphonuclear infiltration were similar to the control group and lesser than the BS group. The lethal concentration of SJW was 2.58 gr/mL.
CONCLUSION


SJW substrate is effective in protecting the esophagus and stomach in mild to moderate alcali corrosive burns in the subacute period. We should keep in mind the protective effects of STW substrate in alkaline corrosive burns of the gastrointestinal system.",2020,"In the stomach, mucosal damage, gastric gland dilatation, submucosal polymorphonuclear infiltration were similar to the control group and lesser than the BS group.",['42 Wistar albino rats weighing between 200-300 grams'],"['Burn+Plasebo (BP', 'Placebo', 'Burn+Saline (BS), Group 3: Burn+St', 'SJW substrate', ""plant St. John 's Wort (Hypericum perforatum"", ""Hyperium perforatum (St. John's Wort"", 'placebo']","['lethal concentration of SJW', 'esophagus, stomach and liver tissue samples', 'mucosal damage, gastric gland dilatation, submucosal polymorphonuclear infiltration', 'weight of the rats', 'submucosal collagen accumulation, muscularis mucosa damage, tunica muscularis damage and collagen accumulation in esophagus']","[{'cui': 'C0001916', 'cui_str': 'Albinism'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439208', 'cui_str': 'g'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0813171', 'cui_str': ""ST. JOHN'S WORT EXTRACT""}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0454976', 'cui_str': 'St. John'}, {'cui': 'C1528417', 'cui_str': 'Hyperium'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0813171', 'cui_str': ""ST. JOHN'S WORT EXTRACT""}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0586688', 'cui_str': 'Tissue specimen from liver'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0017130', 'cui_str': 'Gastric Glands'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0225357', 'cui_str': 'Muscularis mucosae'}, {'cui': 'C0027088', 'cui_str': 'Myometrial structure'}]",,0.0407111,"In the stomach, mucosal damage, gastric gland dilatation, submucosal polymorphonuclear infiltration were similar to the control group and lesser than the BS group.","[{'ForeName': 'Erkan', 'Initials': 'E', 'LastName': 'Güvenç', 'Affiliation': 'Department of Emergency Medicine, Buca Seyfi Demirsoy State Hospital, İzmir-Turkey.'}, {'ForeName': 'Selahattin', 'Initials': 'S', 'LastName': 'Kıyan', 'Affiliation': 'Department of Emergency Medicine, Ege University Faculty of Medicine Hospital, İzmir-Turkey.'}, {'ForeName': 'Yiğit', 'Initials': 'Y', 'LastName': 'Uyanıkgil', 'Affiliation': 'Department of Histology and Embryology, Ege University Faculty of Medicine, İzmir-Turkey.'}, {'ForeName': 'Emel Öykü', 'Initials': 'EÖ', 'LastName': 'Çetin', 'Affiliation': 'Department of Pharmaceutical Technology, Ege University Faculty of Pharmacy, İzmir-Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Karabey', 'Affiliation': 'Department of Biotechnology, Ege University Graduate School of Natural and Applied Sciences, İzmir-Turkey.'}, {'ForeName': 'Türker', 'Initials': 'T', 'LastName': 'Çavuşoğlu', 'Affiliation': 'Department of Histology and Embryology, Ege University Faculty of Medicine, İzmir-Turkey.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Gökçe', 'Affiliation': 'Department of Zoology, Ege University Faculty of Science, İzmir-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2019.93428']
2885,32425006,Efficacy of internet-based integrated intervention on depression and anxiety symptoms in patients with COVID-19.,"Public health crises, such as the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) since Dec. 2019, are widely acknowledged as severe traumatic events that impose threats not only because of physical concerns but also because of the psychological distress of infected patients. We designed an internet-based integrated intervention and evaluated its efficacy on depression and anxiety symptoms in patients infected by SARS-CoV-2.",2020,We designed an internet-based integrated intervention and evaluated its efficacy on depression and anxiety symptoms in patients infected by SARS-CoV-2.,"['patients with COVID-19', 'patients infected by SARS-CoV-2']",['internet-based integrated intervention'],['depression and anxiety symptoms'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0207417,We designed an internet-based integrated intervention and evaluated its efficacy on depression and anxiety symptoms in patients infected by SARS-CoV-2.,"[{'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wei', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Bo-Chao', 'Initials': 'BC', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Shao-Jia', 'Initials': 'SJ', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Jian-Bo', 'Initials': 'JB', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Xiao-Yi', 'Initials': 'XY', 'LastName': 'Zhou', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Chan-Chan', 'Initials': 'CC', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Jing-Kai', 'Initials': 'JK', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Jin-Wen', 'Initials': 'JW', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Shu-Guang', 'Initials': 'SG', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Dan-Dan', 'Initials': 'DD', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Shao-Hua', 'Initials': 'SH', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}]",Journal of Zhejiang University. Science. B,['10.1631/jzus.B2010013']
2886,32439008,Subcutaneous Selatogrel Inhibits Platelet Aggregation in Patients With Acute Myocardial Infarction.,"BACKGROUND


Oral P2Y 12  receptor antagonists exhibit delayed onset of platelet inhibition in patients with acute myocardial infarction (AMI). Selatogrel is a potent, highly selective, and reversible P2Y 12  receptor antagonist with a rapid onset and short duration of action.
OBJECTIVES


This study sought to assess inhibition of platelet aggregation following subcutaneous administration of selatogrel in patients with AMI.
METHODS


Patients with AMI were randomized to a single subcutaneous dose of selatogrel of 8 or 16 mg. The primary endpoint was response to treatment (P2Y 12  reaction units <100; measured by VerifyNow) at 30 min post-dose. Safety was assessed up to 48 h post-injection.
RESULTS


Forty-seven patients received selatogrel 8 mg (n = 24) or 16 mg (n = 23) followed by ticagrelor (n = 43) or clopidogrel (n = 1). The proportion of responders 30 min post-dose was 91% (one-sided 97.5% confidence interval [CI]: 80% to 100%) and 96% (97.5% CI: 87% to 100%) with 8 and 16 mg, respectively (p values for responders >85% target; p = 0.142 and p = 0.009, respectively). Response rates were independent from type of AMI presentation, age, or sex. A similar response rate was observed at 15 min (8 mg: 75% [97.5% CI: 58% to 100%]; 16 mg: 91% [97.5% CI: 80% to 100%]), which was sustained at 60 min post-dose (8 mg: 75% [97.5% CI: 58% to 100%]; 16 mg: 96% [97.5% CI: 87% to 100%]). At 15 min, median P2Y 12  reaction units was 51 (range: 4 to 208) for 8 mg and 9 (range: 2 to 175) for 16 mg. Selatogrel was well tolerated, without major bleeding complications.
CONCLUSIONS


Single-dose subcutaneous administration of selatogrel in patients with AMI was safe and induced a profound, rapid, and dose-related antiplatelet response. (A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack; NCT03487445, 2018-000765-36 [EudraCT]).",2020,"The proportion of responders 30 min post-dose was 91% (one-sided 97.5% confidence interval [CI]: 80% to 100%) and 96% (97.5% CI: 87% to 100%) with 8 and 16 mg, respectively (p values for responders >85% target; p = 0.142 and p = 0.009, respectively).","['Adults With Heart Attack; NCT03487445, 2018-000765-36 [EudraCT', 'Patients With Acute Myocardial Infarction', 'Patients with AMI', 'patients with AMI', 'patients with acute myocardial infarction (AMI']","['ACT-246475', 'Subcutaneous Selatogrel', 'clopidogrel', 'ticagrelor']","['Response rates', 'Safety', 'response rate', 'response to treatment (P2Y 12  reaction units\xa0<100; measured by VerifyNow']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}]","[{'cui': 'C4079264', 'cui_str': 'ACT-246475'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.112584,"The proportion of responders 30 min post-dose was 91% (one-sided 97.5% confidence interval [CI]: 80% to 100%) and 96% (97.5% CI: 87% to 100%) with 8 and 16 mg, respectively (p values for responders >85% target; p = 0.142 and p = 0.009, respectively).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sinnaeve', 'Affiliation': 'Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Fahrni', 'Affiliation': 'Department of Cardiology, University Hospital Basel, University Basel, Basel, Switzerland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Schelfaut', 'Affiliation': 'Cardiovascular Center Aalst, OLV-Clinic Aalst, Aalst, Belgium.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'Department of Cardiology and Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Frenoux', 'Affiliation': 'Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Abdel', 'Initials': 'A', 'LastName': 'Hmissi', 'Affiliation': 'Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Bernaud', 'Affiliation': 'Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Ufer', 'Affiliation': 'Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Tiziano', 'Initials': 'T', 'LastName': 'Moccetti', 'Affiliation': 'Cardiology Cardiocentro-Ticino, Lugano, Switzerland.'}, {'ForeName': 'Shaul', 'Initials': 'S', 'LastName': 'Atar', 'Affiliation': 'Department of Cardiology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: marco.valgimigli@insel.ch.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.03.059']
2887,32439135,"Effect of supportive counseling on pregnancy-specific stress, general stress, and prenatal health behaviors: A multicenter randomized controlled trial.","OBJECTIVE


The aim of this study was to investigate the effects of group supportive counseling (SC) on pregnancy-specific stress, general stress, and healthy behavior of pregnant women.
METHODS


This randomized controlled trial study was conducted on 80 pregnant women in two groups; SC for six sessions, once a week for two hours (n = 40), and antenatal usual care (AUC) (n = 40). All Participants completed questionnaires measuring pregnancy-specific stress, state anxiety, prenatal health behaviors, perceived stress, and provided a saliva sample for measurement of cortisol at pre-intervention and 6-week post-intervention.
RESULTS


The post-intervention results indicated that the outcome scores decreased more significantly in group SC than in the AUC for total NuPDQ, for state-anxiety, for PSS-14, and for unhealthy behaviors with a large effect size. Also, healthy behaviors were promoted more significantly in SC group than in AUC. However, salivary cortisol levels did not differ between group SC and AUC groups.
CONCLUSION


Group supportive counselling can promote pregnancy stress and healthy behaviors.
PRACTICE IMPLICATIONS


Addition of supportive counseling to prenatal usual care may be suggested for pregnant women with any gestational age who seek methods for improving pregnancy stress and healthy behaviors.",2020,"The post-intervention results indicated that the outcome scores decreased more significantly in group SC than in the AUC for total NuPDQ, for state-anxiety, for PSS-14, and for unhealthy behaviors with a large effect size.","['pregnant women with any gestational age', '80 pregnant women in two groups', 'pregnant women']","['group supportive counseling (SC', 'antenatal usual care (AUC', 'SC', 'supportive counseling']","['pregnancy stress and healthy behaviors', 'pregnancy-specific stress, general stress, and healthy behavior', 'total NuPDQ, for state-anxiety', 'pregnancy-specific stress, general stress, and prenatal health behaviors', 'salivary cortisol levels', 'questionnaires measuring pregnancy-specific stress, state anxiety, prenatal health behaviors, perceived stress, and provided a saliva sample for measurement of cortisol', 'healthy behaviors']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3697360', 'cui_str': 'Supportive counseling'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C1321108', 'cui_str': 'Prenatal health behavior'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",80.0,0.0769546,"The post-intervention results indicated that the outcome scores decreased more significantly in group SC than in the AUC for total NuPDQ, for state-anxiety, for PSS-14, and for unhealthy behaviors with a large effect size.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Esfandiari', 'Affiliation': 'Student Research Committee, Babol University of Medical Sciences, Babol, Iran. Electronic address: maryeikimm@gmail.com.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: mahbob330@yahoo.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nasiri-Amiri', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, IR Iran. Electronic address: nasiri_fa@yahoo.com.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Parsian', 'Affiliation': 'Cellular and Molecular Biology Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: hadiparsian@yahoo.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Chehrazi', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Babol University of Medical Sciences, Babol, Iran. Electronic address: mohamadchehrazi@gmail.com.'}, {'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Pasha', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: dhajarpasha@gmail.com.'}, {'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Omidvar', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: shomidvar@yahoo.com.'}, {'ForeName': 'Hemmat', 'Initials': 'H', 'LastName': 'Gholinia', 'Affiliation': 'Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: h_gholonia@yahoo.com.'}]",Patient education and counseling,['10.1016/j.pec.2020.04.024']
2888,31495292,Metformin's effectiveness in preventing prednisone-induced hyperglycemia in hematological cancers.,"BACKGROUND


Research has established the development of steroid-induced hyperglycemia as a glucometabolic side effect of high-dose prednisone therapy. Few studies, however, have demonstrated preventative measures that could effectively curtail this side effect in susceptible patients undergoing high-dose prednisone treatment.
OBJECTIVE


To assess metformin's prophylactic effectiveness of prednisone-induced hyperglycemia among hematological cancer patients.
SETTING


Prospective randomized controlled trial conducted at the Kenyatta National Hospital Oncology Clinic and Wards, Nairobi, Kenya.
METHOD


Non-hyperglycemic hematological cancer patients on current or newly initiated high-dose prednisone-based chemotherapy were randomized to receive metformin 850 mg once then 850 mg twice daily for two successive weeks each or to the control group receiving the standard care. Patients were subjected to once weekly fasting and 2-h postprandial glucose measurements for four weeks.
MAIN OUTCOME MEASURE


The primary outcome of measure was the development of hyperglycemia defined by fasting capillary blood glucose values >5.6 mmol/L or 2-h postprandial capillary blood glucose values >7.8 mmol/L.
RESULTS


Eighteen of 24 randomized patients completed the study (11 control and 7 treatment). The proportion of the control subjects that developed prediabetes was 72.7% (95% confidence interval 45.5-90.9%) using fasting glucose and 54.5% (95% confidence interval 27.3-81.8%) using 2-h postprandial glucose. One treatment group participant developed prediabetes using fasting glucose, representing 14.3% (95% confidence interval 0-42.9%). No prediabetes was detected using the 2-h postprandial glucose. Analysis of mean fasting glucose between the two arms found no significant difference. However, significant differences in mean 2-h postprandial glucose were noted in week 2 ( p  = 0.0144), week 3 ( p  = 0.0095), and week 4 ( p  = 0.0074) of the study. Double dose (1700 mg) metformin was more effective in lowering blood glucose than single dose (850 mg) ( p  = 1.0000 (fasting),  p  = 0.4531(2-h postprandial).
CONCLUSION


Metformin's prophylactic effectiveness was demonstrated in this randomized study on new and previously exposed non-diabetic cancer patients on high-dose prednisone-based chemotherapy.",2020,"metformin was more effective in lowering blood glucose than single dose (850 mg) ( p  = 1.0000 (fasting),  p  = 0.4531(2-h postprandial).
","['hematological cancers', 'diabetic cancer patients on high-dose', 'Eighteen of 24 randomized patients completed the study (11 control and 7 treatment', 'hematological cancer patients', 'Kenyatta National Hospital Oncology Clinic and Wards, Nairobi, Kenya.\nMETHOD\n\n\nNon-hyperglycemic hematological cancer patients on current or newly initiated high-dose prednisone-based chemotherapy']","['Metformin', 'prednisone-induced hyperglycemia', 'metformin 850\u2009mg once then 850\u2009mg twice daily for two successive weeks each or to the control group receiving the standard care', 'metformin', 'prednisone-based chemotherapy']","['prediabetes using fasting glucose', 'mean fasting glucose', 'development of hyperglycemia defined by fasting capillary blood glucose values', 'lowering blood glucose', '2-h postprandial glucose', 'mean 2-h postprandial glucose']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}]",24.0,0.0487224,"metformin was more effective in lowering blood glucose than single dose (850 mg) ( p  = 1.0000 (fasting),  p  = 0.4531(2-h postprandial).
","[{'ForeName': 'Lucy A', 'Initials': 'LA', 'LastName': 'Ochola', 'Affiliation': 'Division of Pharmaceutics and Pharmacy Practice, School of Pharmacy, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Nyamu', 'Affiliation': 'Division of Pharmaceutics and Pharmacy Practice, School of Pharmacy, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Guantai', 'Affiliation': 'Division of Pharmacology, School of Pharmacy, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Irene W', 'Initials': 'IW', 'LastName': 'Weru', 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}]",Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners,['10.1177/1078155219873048']
2889,32097119,Optimization of Upper Extremity Rehabilitation by Combining Telerehabilitation With an Exergame in People With Chronic Stroke: Protocol for a Mixed Methods Study.,"BACKGROUND


Exergames have the potential to provide an accessible, remote approach for poststroke upper extremity (UE) rehabilitation. However, the use of exergames without any follow-up by a health professional could lead to compensatory movements during the exercises, inadequate choice of difficulty level, exercises not being completed, and lack of motivation to pursue exercise programs, thereby decreasing their benefits. Combining telerehabilitation with exergames could allow continuous adjustment of the exercises and monitoring of the participant's completion and adherence. At present, there is limited evidence regarding the feasibility or efficacy of combining telerehabilitation and exergames for stroke rehabilitation.
OBJECTIVE


This study aims to (1) determine the preliminary efficacy of using telerehabilitation combined with exergames on UE motor recovery, function, quality of life, and motivation in participants with chronic stroke, compared with conventional therapy (the graded repetitive arm supplementary program; GRASP); (2) examine the feasibility of using the technology with participants diagnosed with stroke at home; and (3) identify the obstacles and facilitators for its use by participants diagnosed with stroke and stroke therapists and understand the shared decision-making process.
METHODS


A mixed methods study protocol is proposed, including a randomized, blinded feasibility trial with an embedded multiple case study. The intervention consists of the provision of a remote rehabilitation program, during which participants will use the Jintronix exergame for UE training and the Reacts Application to conduct videoconferenced sessions with the therapists (physical or occupational therapists). We plan to recruit 52 participants diagnosed with stroke, randomly assigned to a control group (n=26; 2-month on-paper home exercise program: the GRASP with no supervision) and an experimental group (n=26; 2-month home program using the technology). The primary outcome is the Fugl-Meyer UE Assessment, a performance-based measure of UE impairment. The secondary outcomes are self-reported questionnaires and include the Motor Activity Log-28 (quality and frequency of use of the UE), Stroke Impact Scale-16 (the quality of life), and Treatment Self-Regulation Questionnaire (motivation). Feasibility data include process, resources, management, and scientific outcomes. Qualitative data will be collected by interviews with both participants and therapists.
RESULTS


At present, data collection was ongoing with one participant who had completed the exergame- telerehabilitation based intervention. We expect to collect preliminary efficacy data of this technology on the functional and motor recovery of the UE, following a stroke; collect feasibility data with users at home (adherence, safety, and technical difficulties); and identify the obstacles and facilitators for the technology use and understand the shared decision-making process.
CONCLUSIONS


This paper describes the protocol underlying the study of a telerehabilitation-exergame technology to contribute to understanding its feasibility and preliminary efficacy for UE stroke rehabilitation.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03759106; http://clinicaltrials.gov/show/NCT03759106.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/14629.",2020,"BACKGROUND


Exergames have the potential to provide an accessible, remote approach for post stroke upper extremity (UE) rehabilitation.","['participants with chronic stroke, compared with conventional therapy (the graded repetitive arm supplementary program) 2', '52 stroke participants', 'people with chronic stroke']","['Jintronix exergame for UE training and the Reacts Application to conduct video conferenced sessions with the therapists (physical or occupational therapists', 'control group (n=26, 2 months on-paper home exercise program: the graded repetitive arm supplementary program with no supervision']","['self-reported questionnaires and include the Motor Activity Log-28 (quality and frequency of use of the UE in 28 everyday tasks), Stroke Impact Scale-16 (impact on quality of life) and Treatment Self-Regulation Questionnaire (motivation', 'Feasibility data include process (recruitment and retention rates), resources (exercise adherence, time spent with therapist,), management (technical problems)and scientific (safety, simple size) outcomes', 'Fugl-Meyer UE Assessment, a performance-based measure of UE impairment', 'UE motor recovery, function, quality of life and motivation']","[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0441661', 'cui_str': 'Everyday tasks (observable entity)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",52.0,0.0591919,"BACKGROUND


Exergames have the potential to provide an accessible, remote approach for post stroke upper extremity (UE) rehabilitation.","[{'ForeName': 'Dorra Rakia', 'Initials': 'DR', 'LastName': 'Allegue', 'Affiliation': 'School of Rehabilitation, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Dahlia', 'Initials': 'D', 'LastName': 'Kairy', 'Affiliation': 'School of Rehabilitation, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Higgins', 'Affiliation': 'School of Rehabilitation, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Archambault', 'Affiliation': 'McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Michaud', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Miller', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Shane Norman', 'Initials': 'SN', 'LastName': 'Sweet', 'Affiliation': 'The Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal, Institut universitaire sur la réadaptation en déficience physique de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Tousignant', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, QC, Canada.'}]",JMIR research protocols,['10.2196/14629']
2890,32433648,Pre-injury activity predicts outcomes following distal radius fractures in patients age 60 and older.,"INTRODUCTION


One out of every 5 elderly patients will suffer a distal radius fracture and these injuries are often related to poor bone health. Several surgical subspecialties have demonstrated that pre-injury activity level can impact patient outcomes. To determine the importance of physical activity, we examined the relationship between pre-injury activity and patient-reported and functional outcomes among fracture patients.
METHODS


This is a retrospective analysis of prospectively collected data from participants enrolled in the Wrist and Radius Injury Surgical Trial (WRIST) from April 10, 2012 to December 31, 2016. This study included 304 adults, 60 years or older with isolated unstable distal radius fractures; 187 were randomized to one of three surgical treatments and 117 opted for casting. Participants opting for surgery were randomized to receive volar locking plate, percutaneous pinning, or external fixation. Participants who chose not to have surgery were treated with casting. All participants were stratified prior to analysis into highly and less-active groups based on pre-injury Rapid Assessment of Physical Activity Scores.
RESULTS


280 patients had 12-month assessments of outcomes. Highly active participants scored 8 and 5 points greater on the Michigan Hand Questionnaire at 6 weeks and 3 months respectively, p<0.05. Highly active participants demonstrated greater grip strength at the 3-month (p = 0.017) and 6-month (p = 0.007) time-points. Highly active participants treated with volar locking plate scored 10+ points greater on the Michigan Hand Questionnaire compared to the less-active group at the 6-week (p = 0.032), 3-month (p = 0.009) and 12-month (0.004) time points, with an effect size larger than 0.50, suggesting pre-injury level of activity had a significant clinical impact.
CONCLUSIONS


Higher levels of pre-injury activity are predictive of patient-reported and functional outcomes following distal radius fracture. Because of the greater PROs, the early mobility and lower risk of hardware infection reported in the literature, volar plating is preferable to other treatments for highly active patients who request and meet indications for surgery.
TRIAL REGISTRATION


clinicaltrials.gov identifier: NCT01589692.",2020,"Highly active participants scored 8 and 5 points greater on the Michigan Hand Questionnaire at 6 weeks and 3 months respectively, p<0.05.","['Participants opting for surgery', '280 patients had 12-month assessments of outcomes', 'fracture patients', 'patients age 60 and older', 'Participants who chose not to have surgery were treated with casting', '304 adults, 60 years or older with isolated unstable distal radius fractures; 187', 'participants enrolled in the Wrist and Radius Injury Surgical Trial (WRIST) from April 10, 2012 to December 31, 2016']","['volar locking plate', 'volar locking plate, percutaneous pinning, or external fixation', 'distal radius fractures']","['Physical Activity Scores', 'grip strength', 'Michigan Hand Questionnaire']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",304.0,0.0768138,"Highly active participants scored 8 and 5 points greater on the Michigan Hand Questionnaire at 6 weeks and 3 months respectively, p<0.05.","[{'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Hooper', 'Affiliation': 'Hand Surgery Fellow, Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'PhD Candidate, Department of Biostatistics, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Associate Professor, Department of Biostatistics, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Shauver', 'Affiliation': 'Clinical Research Coordinator, Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Chung', 'Affiliation': 'Charles B. G. de Nancrede Professor of Surgery, Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor, MI, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0232684']
2891,31498308,Home-Based Prescribed Pulmonary Exercise in Patients with Stable Chronic Obstructive Pulmonary Disease.,"As a systemic disease, chronic obstructive pulmonary disease (COPD) affects the respiratory system, inducing restless and exercise dyspnea. It also impacts exercise capacity and forms a vicious circle in which it further aggravates the condition of patients and accelerates disease progression. As a functional holistic exercise, traditional Chinese exercises (TCE) play an important role in the rehabilitation of COPD on the basis of adjusting the breath and performing coordinated movements. This study investigates the effects of prescribed pulmonary exercises (which are modified from TCE) on exercise capacity of upper and lower limbs, endurance exercise capacity, and quality of life in stable COPD patients. The goal is to determine the accessibility of these prescribed exercises in COPD rehabilitation. Participants are randomly divided into a non-exercise control group (CG) or prescribed pulmonary exercise group (PG) at a ratio of 1: 1. The PG receives intervention for 60 min twice per day, 7 days a week, for a total of 3 months. The intensity is measured using the Borg category-ratio 10 scale and with a heart-rate monitor. Then, an exercise capacity test and quality of life questionnaire are scheduled at 1 week before and after the formal intervention. After 3 months of intervention, the 30 s arm curl test, 30 s sit-to-stand test, 6 min walking test, and quality of life show significant improvement in COPD patients (p < 0.05). These findings indicate that prescribed pulmonary exercises can be applied as alternative, convenient, and effective home- and community-based exercises for stable COPD patients.",2019,"After 3 months of intervention, the 30 s arm curl test, 30 s sit-to-stand test, 6 min walking test, and quality of life show significant improvement in COPD patients (p < 0.05).","['Patients with Stable Chronic Obstructive Pulmonary Disease', 'stable COPD patients']","['Home-Based Prescribed Pulmonary Exercise', 'non-exercise control group (CG) or prescribed pulmonary exercise group (PG', 'prescribed pulmonary exercises (which are modified from TCE', 'functional holistic exercise, traditional Chinese exercises (TCE']","['exercise capacity test and quality of life questionnaire', 'exercise capacity of upper and lower limbs, endurance exercise capacity, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}]",,0.0226112,"After 3 months of intervention, the 30 s arm curl test, 30 s sit-to-stand test, 6 min walking test, and quality of life show significant improvement in COPD patients (p < 0.05).","[{'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine; Institute of Rehabilitation Medicine, Shanghai Academy of Traditional Chinese Medicine.'}, {'ForeName': 'Peijun', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport.'}, {'ForeName': 'Yufan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport.'}, {'ForeName': 'Zhengrong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport.'}, {'ForeName': 'Zhenwei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Shan', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine; Institute of Rehabilitation Medicine, Shanghai Academy of Traditional Chinese Medicine; tcm4463@outlook.com.'}, {'ForeName': 'Weibing', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Sports Medicine, Shanghai University of Sport; wwb75@126.com.'}]",Journal of visualized experiments : JoVE,['10.3791/59765']
2892,31399302,Cost-effectiveness of abiraterone versus docetaxel in the treatment of metastatic hormone naïve prostate cancer.,"PURPOSE


Prostate cancer is the second leading cause of cancer death in men in the US. Since 2015, landmark studies have demonstrated improved survival outcomes with the use of docetaxel (DCT) or abiraterone (AA) in addition to androgen deprivation therapy (ADT) in the metastatic hormone-naïve setting. These treatment strategies have not been prospectively compared but have similar overall survival benefits despite differing mechanisms of action, toxicity, and cost. We performed a cost-effectiveness analysis to provide insight into the value of AA vs. DCT in the first-line treatment of metastatic prostate cancer.
MATERIALS AND METHODS


We developed Markov models by using a US-payer perspective and a 3-year time horizon to estimate costs (2018 US$) and progression-free quality-adjusted life years (PF-QALYs) for ADT alone, DCT, and AA. Health states were defined as initial state, treatment states according to experience of an adverse event, and progressed disease/death. State transition probabilities were derived from rates for drug discontinuation, frequency of adverse events, disease progression, and death from the randomized phase III trials ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) and LATITUDE. Univariate and probabilistic sensitivity analyses were conducted to evaluate model uncertainty.
RESULTS


DCT resulted in an increase of 0.32 PF-QALYs and $16,100 in cost and AA resulted in an increase of 0.52 PF-QALYs and $215,800 in cost compared to ADT alone. The incremental cost-effectiveness ratio for DCT vs. ADT was $50,500/PF-QALY and for AA vs. DCT was $1,010,000/PF-QALY. Probabilistic sensitivity analysis demonstrated that at a willingness-to-pay threshold of $150,000/PF-QALY AA was highly unlikely to be cost-effective.
CONCLUSION


DCT is substantially more cost-effective than AA in the treatment of metastatic hormone naïve prostate cancer.",2019,"The incremental cost-effectiveness ratio for DCT vs. ADT was $50,500/PF-QALY and for AA vs. DCT was $1,010,000/PF-QALY.",['metastatic hormone naïve prostate cancer'],"['DCT', 'docetaxel (DCT) or abiraterone (AA', 'abiraterone versus docetaxel']","['frequency of adverse events, disease progression, and death', 'survival outcomes', '3-year time horizon to estimate costs (2018 US$) and progression-free quality-adjusted life years (PF-QALYs) for ADT alone, DCT, and AA', 'incremental cost-effectiveness ratio']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0308113,"The incremental cost-effectiveness ratio for DCT vs. ADT was $50,500/PF-QALY and for AA vs. DCT was $1,010,000/PF-QALY.","[{'ForeName': 'Chethan', 'Initials': 'C', 'LastName': 'Ramamurthy', 'Affiliation': 'Mays Cancer Center UT Health San Antonio, San Antonio, TX. Electronic address: ramamurthyc@uthscsa.edu.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Handorf', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Andres F', 'Initials': 'AF', 'LastName': 'Correa', 'Affiliation': 'MD Anderson Cancer Center at Cooper, Camden, NJ.'}, {'ForeName': 'J Robert', 'Initials': 'JR', 'LastName': 'Beck', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Geynisman', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}]",Urologic oncology,['10.1016/j.urolonc.2019.05.017']
2893,32433753,Single-dose pharmacokinetics of temocillin in plasma and soft tissues of healthy volunteers after intravenous and subcutaneous administration: a randomized crossover microdialysis trial.,"BACKGROUND


The antibiotic temocillin has recently been rediscovered as a promising therapeutic option against MDR Gram-negative bacteria. However, some aspects of the pharmacokinetic (PK) profile of the drug are still to be elucidated: subcutaneous administration of temocillin might be of interest as an alternative to the intravenous route in selected patients. Similarly, information on the penetration of temocillin into human soft tissues is lacking.
OBJECTIVES


To investigate the feasibility and plasma PK of subcutaneous dosing as well as soft tissue PK of temocillin after intravenous administration to healthy volunteers.
METHODS


Eight healthy volunteers received 2 g of temocillin both as intravenous and subcutaneous infusion in a randomized two-period crossover study. Concentration-time profiles of total temocillin in plasma (after both routes) and of unbound temocillin in plasma, muscle and subcutis (only after intravenous dosing) were determined up to 12 h post-dose.
RESULTS


Subcutaneous dosing caused some infusion site discomfort but resulted in sustained drug concentrations over time with only slightly decreased overall exposure compared with intravenous dosing. Plasma protein binding of temocillin showed concentration-dependent behaviour and was higher than previously reported. Still, unbound drug concentrations in muscle and subcutis determined by microdialysis markedly exceeded those in plasma, suggesting good tissue penetration of temocillin.
CONCLUSIONS


The subcutaneous administration of temocillin is a valid and feasible alternative to intravenous dosing. With the description of plasma protein binding and soft tissue PK of temocillin in healthy volunteers, this study provides important information that adds to the ongoing characterization of the PK profile of temocillin and might serve as input for PK/PD considerations.",2020,"RESULTS


Subcutaneous dosing caused some infusion site discomfort but resulted in sustained drug concentrations over time with only slightly decreased overall exposure compared with intravenous dosing.","['Eight healthy volunteers', 'healthy volunteers', 'healthy volunteers after intravenous and subcutaneous administration']","['temocillin', '2\u2009g of temocillin both as intravenous and subcutaneous infusion']",['infusion site discomfort'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0076079', 'cui_str': 'temocillin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0576773', 'cui_str': 'Subcutaneous infusion'}]","[{'cui': 'C2721735', 'cui_str': 'Infusion site discomfort'}]",8.0,0.0220943,"RESULTS


Subcutaneous dosing caused some infusion site discomfort but resulted in sustained drug concentrations over time with only slightly decreased overall exposure compared with intravenous dosing.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Matzneller', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Perrin', 'Initials': 'P', 'LastName': 'Ngougni Pokem', 'Affiliation': 'Pharmacologie cellulaire et moléculaire, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Capron', 'Affiliation': 'Clinical Chemistry Department, Cliniques Universitaires St. Luc, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Lackner', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Wulkersdorfer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Nussbaumer-Pröll', 'Affiliation': 'Department of Medicine 1, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Österreicher', 'Affiliation': 'Department of Medicine 1, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Duchek', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Van de Velde', 'Affiliation': 'EUMEDICA S.A. Manage, Belgium.'}, {'ForeName': 'Pierre E', 'Initials': 'PE', 'LastName': 'Wallemacq', 'Affiliation': 'Clinical Chemistry Department, Cliniques Universitaires St. Luc, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Johan W', 'Initials': 'JW', 'LastName': 'Mouton', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Van Bambeke', 'Affiliation': 'Pharmacologie cellulaire et moléculaire, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Zeitlinger', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa176']
2894,31882288,Temporal Summation in Chronic Pelvic Pain.,"OBJECTIVE


This study sought to characterize central sensitization further among women with chronic pelvic pain by identifying temporal summation using a cotton-tipped applicator test that can be used at the bedside.
METHOD


A total of 36 women (18 with chronic pain and allodynia; 18 without pain) were recruited. Both groups were randomly assigned to receive 3 strokes of a benign stimulus on the abdomen at differing frequencies: 10, 30, or 100 seconds. Each group included 6 women. Pain was assessed using a rating scale of 1 to 10. Data were analyzed using the multivariate approach to repeated measures analysis of variance.
RESULTS


The pattern of pain scores differed significantly between women with and without chronic pain (P = 0.002). Women with chronic pelvic pain and allodynia showed a statistically significant increase in pain with successive strokes of the cotton-tipped applicator (P = 0.012 for stroke 1 vs. 2, P = 0.026 for stroke 2 vs. 3, and P = 0.005 for stroke 1 vs. 3).
CONCLUSION


Women with chronic pelvic pain and allodynia showed significant worsening of pain with successive strokes of a cotton-tipped applicator. This finding indicates that pain wind-up and central sensitization are present in women with chronic pelvic pain and allodynia. Identification of summation is further evidence of neuroplasticity, which is helpful in innovative therapies for chronic pelvic pain.",2020,"Women with chronic pelvic pain and allodynia showed a statistically significant increase in pain with successive strokes of the Q-tip (P = 0.012 for stroke 1 vs. 2, P = 0.026 for stroke 2 vs. 3, and P = 0.005 for stroke 1 vs. 3).
","['chronic pelvic pain', 'women with chronic pelvic pain and allodynia', 'women with chronic pelvic pain', 'Chronic Pelvic Pain', '36 women (18 with chronic pain and allodynia; 18 without pain']",[],"['pain with successive strokes of the Q-tip', 'chronic pelvic pain and allodynia', 'Pain', 'pattern of pain scores']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C1286321', 'cui_str': 'Pattern of pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",36.0,0.0823387,"Women with chronic pelvic pain and allodynia showed a statistically significant increase in pain with successive strokes of the Q-tip (P = 0.012 for stroke 1 vs. 2, P = 0.026 for stroke 2 vs. 3, and P = 0.005 for stroke 1 vs. 3).
","[{'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Thompson', 'Affiliation': 'Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, Calgary, AB.'}, {'ForeName': 'Selphee', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, Calgary, AB.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Jarrell', 'Affiliation': 'Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, Calgary, AB. Electronic address: john.jarrell@ahs.ca.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2019.09.012']
2895,32433790,Narrow-band imaging with near-focus magnification for discriminating the gastric tumor margin before endoscopic resection: A prospective randomized multicenter trial.,"BACKGROUND AND AIM


This study investigated the usefulness of near-focus narrow-band imaging (NF-NBI) for determining gastric tumor margins compared with indigo carmine chromoendoscopy (ICC) before endoscopic submucosal dissection (ESD).
METHODS


This prospective randomized controlled trial was conducted at seven teaching hospitals in Korea. Patients with gastric adenoma or differentiated adenocarcinoma undergoing ESD were enrolled and randomly assigned to the NF-NBI or ICC group. A marking dot was placed on the most proximal margin of the tumor before ESD. The primary endpoint was delineation accuracy which was defined as presence of marking dots within 1 mm of the tumor margin under microscopic observation.
RESULTS


A total of 200 patients in the NF-NBI group and 195 patients in the ICC group were included. The delineation accuracy rate was 84.5% in the NF-NBI group and 81.0% in the ICC group (P = 0.44). However, the distance from the marking dot to the margin of the tumor was significantly shorter in the NF-NBI group than in the ICC group (0.8 ± 0.8 mm vs. 1.2 ± 1.3 mm, P < 0.01). Even after adjustment of other clinicopathological factors that are associated with difficulty of tumor delineation, NF-NBI did not show significant association with accurate delineation (Odds ratio of 0.86, P = 0.60).
CONCLUSIONS


This prospective multicenter study showed that NF-NBI is not superior to ICC in terms of accurately delineating gastric tumors (NCT02661945).",2020,This prospective multicenter study showed that NF-NBI is not superior to ICC in terms of accurately delineating gastric tumors (NCT02661945).,"['seven teaching hospitals in Korea', 'Patients with gastric adenoma or differentiated adenocarcinoma undergoing ESD', '200 patients in the NF-NBI group and 195 patients in the ICC group were included']","['indigo carmine chromoendoscopy (ICC', 'NF-NBI or ICC', 'Narrow-band imaging with near-focus magnification', 'NF-NBI', 'ICC', 'near-focus narrow-band imaging (NF-NBI', 'endoscopic resection']","['delineation accuracy', 'delineation accuracy rate']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149826', 'cui_str': 'Gastric adenoma'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0021219', 'cui_str': 'indigo carmine'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0021219', 'cui_str': 'indigo carmine'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}]",200.0,0.0637564,This prospective multicenter study showed that NF-NBI is not superior to ICC in terms of accurately delineating gastric tumors (NCT02661945).,"[{'ForeName': 'Jung-Wook', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yunho', 'Initials': 'Y', 'LastName': 'Jung', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Soon Chun Hyang University College of Medicine, Cheonan, South Korea.'}, {'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Gwang Ha', 'Initials': 'GH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Pusan National University School of Medicine, and Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'Byoung Wook', 'Initials': 'BW', 'LastName': 'Bang', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, South Korea.'}, {'ForeName': 'Jun Chul', 'Initials': 'JC', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyuk Soon', 'Initials': 'HS', 'LastName': 'Choi', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jun-Hyung', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Digestive Disease Center, Soon Chun Hyang University Hospital, Seoul, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15109']
2896,32433779,Predictors of Systemic Exposure to Topical Crisaborole: A Nonlinear Regression Analysis.,"Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate atopic dermatitis. Results from 2 randomized, double-blind, vehicle-controlled phase 3 studies showed that twice-daily crisaborole in children and adults with mild to moderate atopic dermatitis was efficacious and well tolerated. Initial pharmacokinetics (PK) studies of crisaborole indicated absorption with measurable systemic levels of crisaborole. The current analysis was conducted to correlate steady-state systemic exposure parameters with ointment dose and identify covariates impacting PK parameters in healthy participants and patients with atopic dermatitis or psoriasis. A nonlinear regression analysis was conducted using ointment dose and noncompartmental PK parameters at steady state (area under the curve [AUC ss  ] and maximum concentration [C max,ss  ]). PK data were available from 244 participants across 6 clinical studies (AUC ss  , N = 239; C max,ss  , N = 241). Disease condition had the greatest impact on slope in both models, corresponding to 2.5-fold higher AUC ss  and C max,ss  values at a given ointment dose in patients with atopic dermatitis or psoriasis relative to healthy participants. Disease severity, race/ethnicity, and sex had marginal effects on AUC ss  and C max,ss  . Systemic exposures were similar across age groups ≥2 years of age when the same percentage of body surface area (%BSA) was treated. Predictive performance plots for AUC ss  and C max,ss  for different age groups demonstrated that the models adequately describe the observed data. Model predictions indicated that systemic exposure to crisaborole in pediatric patients (2-17 years) is unlikely to exceed systemic exposure in adults (≥18 years), even at the highest possible ointment dose corresponding to a %BSA of 90.",2020,"Predictive performance plots for AUC ss  and C max,ss  for different age groups demonstrated that the models adequately describe the observed data.","['children and adults with mild to moderate atopic dermatitis', 'healthy participants and patients with atopic dermatitis or psoriasis', 'pediatric patients (2-17\xa0years', '244 participants across 6 clinical studies (AUC ss  , N = 239; C max,ss  , N = 241', 'mild to moderate atopic dermatitis', 'patients with atopic dermatitis or psoriasis relative to healthy participants']","['Crisaborole ointment', 'Topical Crisaborole']","['efficacious and well tolerated', 'Systemic exposures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C4301784', 'cui_str': 'crisaborole Topical Ointment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4301781', 'cui_str': 'crisaborole'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.0366952,"Predictive performance plots for AUC ss  and C max,ss  for different age groups demonstrated that the models adequately describe the observed data.","[{'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Purohit', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Riley', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Huaming', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Ports', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1624']
2897,31831801,"A randomised clinical trial to evaluate the safety, fit, comfort of a novel N95 mask in children.","Children are more vulnerable to the risks of air pollution, including susceptibility to acquiring chronic diseases in their developing lungs. Despite these, there are no specific masks designed for and tested in children that are available to protect our young from the common particulate air pollutants today. We evaluated safety, fit and comfort of a specially designed paediatric N95 mask with an optional micro ventilator (micro fan, MF) in healthy children aged 7-14 years, in a randomized, two-period crossover design. The subjects' cardiorespiratory physiological measurements were assessed in different states of physical activity under different interventions (mask without and with MF). A total of 106 subjects were recruited between July-August 2016. The use of the mask without MF increased the End-Tidal CO 2  (ETCO 2 ) and Fractional concentration of Inspired CO 2  (FICO 2 ) at rest and on mild exertion, as expected. The use of the mask with MF brought FICO 2  levels comparably closer to baseline levels without the mask for both activities. The mask, with or without the MF, was found to be well fitting, comfortable and safe for use in children at rest and on mild exertion. The N95 mask tested offers a promising start for more studies in the paediatric population.",2019,"The mask, with or without the MF, was found to be well fitting, comfortable and safe for use in children at rest and on mild exertion.","['healthy children aged 7-14 years', 'children', 'A total of 106 subjects were recruited between July-August 2016']","['paediatric N95 mask with an optional micro ventilator (micro fan, MF']",['End-Tidal CO 2  (ETCO 2 ) and Fractional concentration of Inspired CO 2  (FICO 2 ) at rest and on mild exertion'],"[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0441039', 'cui_str': 'Fan (physical object)'}]","[{'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}]",106.0,0.0405321,"The mask, with or without the MF, was found to be well fitting, comfortable and safe for use in children at rest and on mild exertion.","[{'ForeName': 'Daniel Yam Thiam', 'Initials': 'DYT', 'LastName': 'Goh', 'Affiliation': 'Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore. daniel_goh@nuhs.edu.sg.'}, {'ForeName': 'Meng Wai', 'Initials': 'MW', 'LastName': 'Mun', 'Affiliation': 'Innosparks Pte Ltd, Singapore, Singapore.'}, {'ForeName': 'Wei Liang Jerome', 'Initials': 'WLJ', 'LastName': 'Lee', 'Affiliation': 'Innosparks Pte Ltd, Singapore, Singapore.'}, {'ForeName': 'Oon Hoe', 'Initials': 'OH', 'LastName': 'Teoh', 'Affiliation': ""Department of Paediatrics, KK Women's and Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Dimple D', 'Initials': 'DD', 'LastName': 'Rajgor', 'Affiliation': 'Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}]",Scientific reports,['10.1038/s41598-019-55451-w']
2898,31831868,Effect of a Dual PPAR α/γ agonist on Insulin Sensitivity in Patients of Type 2 Diabetes with Hypertriglyceridemia- Randomized double-blind placebo-controlled trial.,"Saroglitazar is a dual PPAR-α/γ agonist approved for the treatment of diabetic dyslipidemia. In addition to reduction in atherogenic lipids, it may also contribute to improvement in insulin sensitivity through PPAR-α/γ agonism, which remains unexplored. We conducted a randomized, double-blind, placebo-controlled trial in treatment-naive T2DM individuals with serum triglyceride >150 mg/dL. Participants were randomized to receive either saroglitazar 4 mg or placebo (1:1) daily for 4 months (n = 30). Insulin sensitivity (SI clamp ) was studied using hyperinsulinemic-euglycemic clamp at baseline and at 4 months. We observed a significant reduction in TG (p = 0.001), HbA1c (p = 0.019) and fasting plasma glucose (p = 0.019) and significant increase in HDL-C levels (p < 0.01) with saroglitazar compared to placebo. Further, patients on saroglitazar had a greater improvement in SI clamp  (p = 0.026) with the effect persisting despite adjusting for baseline weight, TG, HDL-C and HbA1c (p = 0.002). This was accompanied with significant increase in HOMA-β (p = 0.01) in the saroglitazar group and change in HOMA-β showed a trend towards significance with SI clamp  (r = 0.503, p = 0.056). However, change in SI clamp  did not significantly correlate with reduction in HbA1c and TG. We conclude that saroglitazar effectively reduces hypertriglyceridemia and improves insulin sensitivity along with β-cell function by reduction in gluco-lipotoxicity and possibly directly through PPAR-γ agonism in patients ofT2DM with hypertriglyceridemia.",2019,"We observed a significant reduction in TG (p = 0.001), HbA1c (p = 0.019) and fasting plasma glucose (p = 0.019) and significant increase in HDL-C levels (p < 0.01) with saroglitazar compared to placebo.","['Patients of Type 2 Diabetes with Hypertriglyceridemia', 'treatment-naive T2DM\xa0individuals with serum triglyceride\u2009>150\u2009mg/dL. Participants']","['Dual PPAR α/γ agonist', 'saroglitazar 4\u2009mg or placebo', 'placebo']","['hypertriglyceridemia and improves insulin sensitivity', 'atherogenic lipids', 'TG', 'fasting plasma glucose', 'HOMA-β', 'HbA1c and TG', 'Insulin Sensitivity', 'SI clamp', 'Insulin sensitivity (SI clamp ', 'HDL-C levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0166418', 'cui_str': 'Peroxisome Proliferator-Activated Receptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3852920'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.425016,"We observed a significant reduction in TG (p = 0.001), HbA1c (p = 0.019) and fasting plasma glucose (p = 0.019) and significant increase in HDL-C levels (p < 0.01) with saroglitazar compared to placebo.","[{'ForeName': 'Nimisha', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Shobhit', 'Initials': 'S', 'LastName': 'Bhansali', 'Affiliation': 'Diabetes Research and Training Center and Division of Endocrinology, Department of Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Department of Physiology, St. John's Medical College, Bengaluru, India.""}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Hawkins', 'Affiliation': 'Diabetes Research and Training Center and Division of Endocrinology, Department of Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Akhilesh', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Psychiatry, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Ashu', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India. ashuendo@gmail.com.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Bhansali', 'Affiliation': 'Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India. anilbhansaliendocrine@gmail.com.'}]",Scientific reports,['10.1038/s41598-019-55466-3']
2899,31492516,Design and results of aCRT MID-Q study: Adoption of adaptive CRT in patients with normal AV conduction and moderately wide left bundle branch block.,"BACKGROUND


Sub-analysis of the adaptive CRT (aCRT) trial demonstrated the potential benefits of the aCRT algorithm over conventional echo-guided bi-ventricular (BiV) pacing in patients with left bundle branch block (LBBB) with moderately wide QRS (120-149 ms) and normal atrioventricular (AV) conduction.
METHODS


Adoption of Adaptive CRT in Patients with Left Bundle Branch Block and Moderately Wide QRS (aCRT MID-Q, UMIN Clinical Trials Registry Number: 000022452) was a multicenter, prospective, randomized, double-blind study designed to investigate the superiority of the aCRT pacing algorithm compared to echo-guided BiV pacing in patients with moderately wide LBBB and normal AV conduction. The primary endpoint was the improvement in clinical composite score (CCS) at 6 months; the secondary endpoints were changes in left ventricular (LV) end-systolic volume, LV ejection fraction, New York Heart Association classification, 6-min walk distance, and quality of life from baseline to 6 months post-randomization; heart failure administration; all-cause mortality; and cardiac mortality within 12 months.
RESULTS


The trial was terminated prematurely after enrollment of 39 patients (aCRT arm; n = 17, echo-guided BiV arm; n = 22) because of lower than expected enrollment. In the intention-to-treat analysis, the improvement of CCS was achieved in 10 patients (59%) in the aCRT arm (n = 17) and 16 patients (73%) in the echo-guided BiV arm (n = 22, p = 0.36). For the secondary endpoint, only 6-min walk distance was significantly greater in the aCRT arm than in the echo-guided BiV arm, and no difference was observed in the echocardiographic parameters. Heart failure hospitalization-free survival was also not significantly different (p = 0.91). There was no death during the follow-up.
CONCLUSIONS


Improvement of CCS was similarly observed after aCRT and echo-guided BiV in CRT recipients with moderately wide LBBB and normal AV conduction. A prospective study is needed to explore the impact of CRT and pacing algorithm on Japanese patients with moderately wide LBBB.",2020,"For the secondary endpoint, only 6-min walk distance was significantly greater in the aCRT arm than in the echo-guided BiV arm, and no difference was observed in the echocardiographic parameters.","['Patients with Left Bundle Branch Block and Moderately Wide QRS (aCRT MID-Q, UMIN Clinical Trials Registry Number: 000022452', 'patients with moderately wide LBBB and normal AV conduction', 'patients with left bundle branch block (LBBB) with moderately wide QRS (120-149\u202fms) and normal atrioventricular (AV) conduction', 'Japanese patients with moderately wide LBBB', 'patients with normal AV conduction and moderately wide left bundle branch block']","['aCRT pacing algorithm compared to echo-guided BiV pacing', 'Adaptive CRT', 'adaptive CRT', 'aCRT', 'aCRT algorithm over conventional echo-guided bi-ventricular (BiV) pacing']","['changes in left ventricular (LV) end-systolic volume, LV ejection fraction, New York Heart Association classification, 6-min walk distance, and quality of life from baseline to 6\u202fmonths post-randomization; heart failure administration; all-cause mortality; and cardiac mortality', 'echocardiographic parameters', 'clinical composite score (CCS', 'CCS', '6-min walk distance', 'Heart failure hospitalization-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006384', 'cui_str': 'Bundle-Branch Block'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0023211', 'cui_str': 'Left Bundle-Branch Block'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C0002045'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0079031', 'cui_str': 'BIV'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.132752,"For the secondary endpoint, only 6-min walk distance was significantly greater in the aCRT arm than in the echo-guided BiV arm, and no difference was observed in the echocardiographic parameters.","[{'ForeName': 'Hiro', 'Initials': 'H', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan. Electronic address: hyamasaki@md.tsukuba.ac.jp.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Sekiguchi', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Gosho', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Nogami', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Aonuma', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.08.003']
2900,31831865,Safety and efficacy of risedronate for patients with esophageal varices and liver cirrhosis: a non-randomized clinical trial.,"Despite the high prevalence of osteoporosis in liver cirrhosis, the indication of bisphosphonates for patients with esophageal varices has been avoided due to risk of digestive mucosal damage. Therefore, this study aimed to evaluate the safety profile of risedronate treatment for patients with osteoporosis, liver cirrhosis and esophageal varices with low risk of bleeding. A total of 120 patients were allocated into two groups according to their bone mineral density measured by dual-energy X-ray absorptiometry. In the intervention group, 57 subjects with osteoporosis received oral risedronate at 35 mg weekly plus daily calcium and vitamin D supplementation. In the control group, 63 subjects with osteopenia received only calcium and vitamin D. The groups received the treatment for one year and underwent surveillance endoscopies at six and 12 months, as well as a control dual-energy X-ray absorptiometry after a 12-month follow-up. The study received Institutional Review Board approval. The groups had not only comparable Model for End-stage Liver Disease score and esophageal varices degree, but also similar incidence of digestive adverse effects. A significant improvement was achieved in the intervention group in the lumbar spine T score (p < 0.001). The results suggest that risedronate may be safely used in liver cirrhosis and esophageal varices with low bleeding risk under endoscopic surveillance, thus allowing bone mass recovery.",2019,A significant improvement was achieved in the intervention group in the lumbar spine T score (p < 0.001).,"['patients with esophageal varices and liver cirrhosis', 'patients with esophageal varices', 'A total of 120 patients', 'patients with osteoporosis, liver cirrhosis and esophageal varices with low risk of bleeding', '57 subjects with osteoporosis received', '63 subjects with osteopenia received only', 'liver cirrhosis and esophageal varices with low bleeding risk under endoscopic surveillance']","['oral risedronate at 35\u2009mg weekly plus daily calcium and vitamin D supplementation', 'calcium and vitamin D', 'risedronate']","['Safety and efficacy', 'Model for End-stage Liver Disease score and esophageal varices degree', 'lumbar spine T score', 'digestive adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014867', 'cui_str': 'Esophageal Varices'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4048785', 'cui_str': 'MELD score'}, {'cui': 'C0014867', 'cui_str': 'Esophageal Varices'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",63.0,0.0374779,A significant improvement was achieved in the intervention group in the lumbar spine T score (p < 0.001).,"[{'ForeName': 'Talles Bazeia', 'Initials': 'TB', 'LastName': 'Lima', 'Affiliation': 'Internal Medicine Department, Gastroenterology Division - São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil.'}, {'ForeName': 'Lívia Alves Amaral', 'Initials': 'LAA', 'LastName': 'Santos', 'Affiliation': 'Internal Medicine Department, Gastroenterology Division - São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil.'}, {'ForeName': 'Hélio Rubens de Carvalho', 'Initials': 'HRC', 'LastName': 'Nunes', 'Affiliation': 'Public Health Department, São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil.'}, {'ForeName': 'Giovanni Faria', 'Initials': 'GF', 'LastName': 'Silva', 'Affiliation': 'Internal Medicine Department, Gastroenterology Division - São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil.'}, {'ForeName': 'Carlos Antonio', 'Initials': 'CA', 'LastName': 'Caramori', 'Affiliation': 'Internal Medicine Department, Gastroenterology Division - São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil.'}, {'ForeName': 'Xingshun', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'General Hospital of Shenyang Military Command, Liaoning, Sheng, China.'}, {'ForeName': 'Fernando Gomes', 'Initials': 'FG', 'LastName': 'Romeiro', 'Affiliation': 'Internal Medicine Department, Gastroenterology Division - São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil. fernando.romeiro@unesp.br.'}]",Scientific reports,['10.1038/s41598-019-55603-y']
2901,31910907,"""Free won't"" after a beer or two: chronic and acute effects of alcohol on neural and behavioral indices of intentional inhibition.","BACKGROUND


Response inhibition can be classified into stimulus-driven inhibition and intentional inhibition based on the degree of endogenous volition involved. In the past decades, abundant research efforts to study the effects of alcohol on inhibition have focused exclusively on stimulus-driven inhibition. The novel Chasing Memo task measures stimulus-driven and intentional inhibition within the same paradigm. Combined with the stop-signal task, we investigated how alcohol use affects behavioral and psychophysiological correlates of intentional inhibition, as well as stimulus-driven inhibition.
METHODS


Experiment I focused on intentional inhibition and stimulus-driven inhibition in relation to past-year alcohol use. The Chasing Memo task, the stop-signal task, and questionnaires related to substance use and impulsivity were administered to 60 undergraduate students (18-25 years old). Experiment II focused on behavioral and neural correlates acute alcohol use on performance on the Chasing Memo task by means of electroencephalography (EEG). Sixteen young male adults (21-28 years old) performed the Chasing Memo task once under placebo and once under the influence of alcohol (blood alcohol concentration around 0.05%), while EEG was recorded.
RESULTS


In experiment I, AUDIT (Alcohol Use Disorder Identification Test) total score did not significantly predict stimulus-driven inhibition or intentional inhibition performance. In experiment II, the placebo condition and the alcohol condition were comparable in terms of behavioral indices of stimulus-driven inhibition and intentional inhibition as well as task-related EEG patterns. Interestingly, a slow negative readiness potential (RP) was observed with an onset of about 1.2 s, exclusively before participants stopped intentionally.
CONCLUSIONS


These findings suggest that both past-year increases in risky alcohol consumption and moderate acute alcohol use have limited effects on stimulus-driven inhibition and intentional inhibition. These conclusions cannot be generalized to alcohol use disorder and high intoxication levels. The RP might reflect processes involved in the formation of an intention in general.",2020,"In experiment II, the placebo condition and the alcohol condition were comparable in terms of behavioral indices of stimulus-driven inhibition and intentional inhibition as well as task-related EEG patterns.","['Sixteen young male adults (21-28\u2009years old', '60 undergraduate students (18-25\u2009years old', 'Experiment']","['Chasing Memo task once under placebo', 'intentional inhibition and stimulus-driven inhibition']","['risky alcohol consumption', 'behavioral indices of stimulus-driven inhibition and intentional inhibition as well as task-related EEG patterns', 'slow negative readiness potential (RP']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1704305', 'cui_str': 'Readiness Potential'}]",16.0,0.029488,"In experiment II, the placebo condition and the alcohol condition were comparable in terms of behavioral indices of stimulus-driven inhibition and intentional inhibition as well as task-related EEG patterns.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Psychology, University of Amsterdam, Nieuwe Achtergracht 129B, 1018, WS, Amsterdam, The Netherlands. y.liu3@uva.nl.'}, {'ForeName': 'Wery P M', 'Initials': 'WPM', 'LastName': 'van den Wildenberg', 'Affiliation': 'Department of Psychology, University of Amsterdam, Nieuwe Achtergracht 129B, 1018, WS, Amsterdam, The Netherlands.'}, {'ForeName': 'Gorka Fraga', 'Initials': 'GF', 'LastName': 'González', 'Affiliation': 'Department of Developmental Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Rigoni', 'Affiliation': 'Department of Experimental Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Brass', 'Affiliation': 'Department of Experimental Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Reinout W', 'Initials': 'RW', 'LastName': 'Wiers', 'Affiliation': 'Department of Psychology, University of Amsterdam, Nieuwe Achtergracht 129B, 1018, WS, Amsterdam, The Netherlands.'}, {'ForeName': 'K Richard', 'Initials': 'KR', 'LastName': 'Ridderinkhof', 'Affiliation': 'Department of Psychology, University of Amsterdam, Nieuwe Achtergracht 129B, 1018, WS, Amsterdam, The Netherlands.'}]",BMC psychology,['10.1186/s40359-019-0367-z']
2902,21431408,Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy improves survival of patients with peritoneal carcinomatosis from gastric cancer: final results of a phase III randomized clinical trial.,"BACKGROUND


This randomized phase III study was to evaluate the efficacy and safety of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) for the treatment of peritoneal carcinomatosis (PC) from gastric cancer.
METHODS


Sixty-eight gastric PC patients were randomized into CRS alone (n = 34) or CRS + HIPEC (n = 34) receiving cisplatin 120 mg and mitomycin C 30 mg each in 6000 ml of normal saline at 43 ± 0.5°C for 60-90 min. The primary end point was overall survival, and the secondary end points were safety profiles.
RESULTS


Major clinicopathological characteristics were balanced between the 2 groups. The PC index was 2-36 (median 15) in the CRS + HIPEC and 3-23 (median 15) in the CRS groups (P = 0.489). The completeness of CRS score (CC 0-1) was 58.8% (20 of 34) in the CRS and 58.8% (20 of 34) in the CRS + HIPEC groups (P = 1.000). At a median follow-up of 32 months (7.5-83.5 months), death occurred in 33 of 34 (97.1%) cases in the CRS group and 29 of 34 (85.3%) cases of the CRS + HIPEC group. The median survival was 6.5 months (95% confidence interval 4.8-8.2 months) in CRS and 11.0 months (95% confidence interval 10.0-11.9 months) in the CRS + HIPEC groups (P = 0.046). Four patients (11.7%) in the CRS group and 5 (14.7%) patients in the CRS + HIPEC group developed serious adverse events (P = 0.839). Multivariate analysis found CRS + HIPEC, synchronous PC, CC 0-1, systemic chemotherapy ≥ 6 cycles, and no serious adverse events were independent predictors for better survival.
CONCLUSIONS


For synchronous gastric PC, CRS + HIPEC with mitomycin C 30 mg and cisplatin 120 mg may improve survival with acceptable morbidity.",2011,The completeness of CRS score (CC 0-1) was 58.8% (20 of 34) in the CRS and 58.8% (20 of 34) in the CRS + HIPEC groups (P = 1.000).,"['patients with peritoneal carcinomatosis from gastric cancer', 'Sixty-eight gastric PC patients', 'peritoneal carcinomatosis (PC) from gastric cancer']","['cisplatin', 'mitomycin C 30', 'CRS\xa0+\xa0HIPEC (n\xa0', 'Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy', 'CRS alone', 'CRS', 'cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC', 'mitomycin C 30\xa0mg each in 6000\xa0ml of normal saline']","['median survival', 'PC index', 'survival with acceptable morbidity', 'safety profiles', 'efficacy and safety', 'serious adverse events', 'overall survival', 'death', 'survival', 'completeness of CRS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4318618', 'cui_str': 'Peritoneal Surface Malignancy'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3842326', 'cui_str': 'Six thousand'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439812', 'cui_str': 'Completeness (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",68.0,0.19381,The completeness of CRS score (CC 0-1) was 58.8% (20 of 34) in the CRS and 58.8% (20 of 34) in the CRS + HIPEC groups (P = 1.000).,"[{'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, Hubei Cancer Clinical Study Center and Hubei Key Laboratory of Tumor Biological Behaviors, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Chao-Qun', 'Initials': 'CQ', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Suo', 'Affiliation': ''}, {'ForeName': 'Lie-Jun', 'Initials': 'LJ', 'LastName': 'Mei', 'Affiliation': ''}, {'ForeName': 'Guo-Liang', 'Initials': 'GL', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Fu-Lin', 'Initials': 'FL', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Yun-Feng', 'Initials': 'YF', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xiong', 'Affiliation': ''}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Yonemura', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}]",Annals of surgical oncology,['10.1245/s10434-011-1631-5']
2903,31883516,Effectiveness of physical therapy treatment in addition to usual podiatry management of plantar heel pain: a randomized clinical trial.,"BACKGROUND


Many patients will seek care from a podiatrist for plantar heel pain (PHP), while few of these patients will also be seen by a physical therapist. Physical therapists can provide treatment that is not a part of routine podiatric care for PHP and may provide additional improvement. Therefore, the purpose of this study was to examine the effects of interdisciplinary care for PHP that incorporated physical therapy treatment after initiating podiatric treatment.
METHODS


Eligible individuals with PHP that presented to a podiatrist were randomized to receive usual podiatric care (uPOD) or usual podiatric care plus physical therapy treatment (uPOD+PT). The primary outcome was change in foot and ankle ability measure (FAAM) at 6-months. Secondary outcomes included change in numeric pain rating scale (NPRS), patient-reported success, and 6-week and 1-year endpoints. Patient-reported success was defined as the top two global rating of change scale rankings. Primary analysis was intention-to-treat (ITT) using analysis by covariance adjusted to baseline scores, and a secondary per-protocol (PP) analysis was performed analyzing only those who completed treatment.
RESULTS


Ninety-five individuals participated and were included in the ITT analysis, and 79 were included in the PP analysis. For the primary outcome of FAAM change from baseline to 6-months, both groups improved significantly (uPOD+PT: 26.8 [95% CI 21.6, 31.9]; uPOD: (20 [15.6, 24.4]), but there was no between-group difference (4.3 [- 1, 9.6]). For secondary outcomes, the uPOD+PT group demonstrated greater improvement in NPRS at 6 weeks (0.9 [0.3, 1.4]) and 1 year (1.5 [0.6, 2.5]) in the ITT analysis. In the PP analysis, the uPOD+PT group demonstrated greater improvement in FAAM at 6 months (7.7 [2.1, 13.3]) and 1 year (5.5 [0.1, 10.8]), NPRS at 6 weeks (0.9 [0.2, 1.6]), 6 months (1.3 [0.6, 2.1]) and 1 year (1.3 [0.6, 2.1]), and in patient-reported success (relative risk [95% CI]) at 6 weeks (2.8 [1.1, 7.1]), 6 months (1.5 [1.1, 2.1]), and 1 year (1.5 [1.1, 1.9]).
CONCLUSIONS


There was no significant benefit of uPOD+PT in the primary outcome of FAAM change at 6 months. Secondary outcomes and PP analysis indicated additional benefit of uPOD+PT, mostly observed in individuals who completed treatment.
TRIAL REGISTRATION


Prospectively registered May 24, 2013 at www.clinicaltrials.gov (NCT01865734).",2019,"For secondary outcomes, the uPOD+PT group demonstrated greater improvement in NPRS at 6 weeks (0.9 [0.3, 1.4]) and 1 year (1.5 [0.6, 2.5]) in the ITT analysis.","['Eligible individuals with PHP that presented to a podiatrist', 'plantar heel pain', 'Ninety-five individuals participated and were included in the ITT analysis, and 79 were included in the PP analysis']","['physical therapy treatment', 'uPOD+PT', 'usual podiatric care (uPOD) or usual podiatric care plus physical therapy treatment (uPOD+PT']","['uPOD', 'intention-to-treat (ITT', 'FAAM change', 'FAAM', 'change in numeric pain rating scale (NPRS), patient-reported success, and 6-week and 1-year endpoints', 'change in foot and ankle ability measure (FAAM', 'NPRS']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0260145', 'cui_str': 'Podiatrist (occupation)'}, {'cui': 'C0231786', 'cui_str': 'Plantar heel pain (finding)'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",95.0,0.300783,"For secondary outcomes, the uPOD+PT group demonstrated greater improvement in NPRS at 6 weeks (0.9 [0.3, 1.4]) and 1 year (1.5 [0.6, 2.5]) in the ITT analysis.","[{'ForeName': 'Shane M', 'Initials': 'SM', 'LastName': 'McClinton', 'Affiliation': 'Doctor of Physical Therapy Program, Des Moines University, 3200 Grand Avenue, Des Moines, IA, USA. shane.mcclinton@dmu.edu.'}, {'ForeName': 'Bryan C', 'Initials': 'BC', 'LastName': 'Heiderscheit', 'Affiliation': 'Departments of Orthopedics & Rehabilitation and Biomedical Engineering, and Doctor of Physical Therapy Program, University of Wisconsin-Madison, 1636 Highland Ave, Madison, WI, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'McPoil', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Flynn', 'Affiliation': 'School of Physical Therapy, South College, Knoxville, TN, USA.'}]",BMC musculoskeletal disorders,['10.1186/s12891-019-3009-y']
2904,31488427,Selective laser trabeculoplasty versus topical medication as initial glaucoma treatment: the glaucoma initial treatment study randomised clinical trial.,"BACKGROUND/AIMS


To determine if selective laser trabeculoplasty (SLT) is superior to topical medication as a first-line treatment for glaucoma on quality of life (QoL) and clinical outcomes.
METHODS


In this international, longitudinal, multisite randomised controlled trial, treatment naïve mild-to-moderate primary open angle or exfoliation glaucoma patients were randomised 1:1 to SLT or topical medication. Glaucoma-specific QoL (primary outcome) was measured using the Glaucoma Outcomes Assessment Tool (GOAT; 342 items, 12 domains). Secondary outcomes included rate of successful intraocular pressure (IOP) reduction (>25% reduction from baseline) and presence of ocular surface disease including conjunctival hyperaemia and eyelid erythema. Our intention-to-treat analysis was performed at months 12 and 24.
RESULTS


Of 167 enrolled patients, 83 and 84 were randomised to SLT and topical medication, respectively; and 145 (n=75 SLT, n=70 medication) completed 24-month follow-up. While both treatment arms achieved significant within-group gains in GOAT outcomes at both endpoints, SLT patients reported a greater between-group improvement in 'social well-being' compared with medication patients (mean±SE=0.28±0.13; p=0.034) at 24 months. At month 24, the rate of successful IOP reduction was 18.6% (95% CI 3.0% to 34.3%, p=0.022) higher (absolute difference) in the medication compared with SLT group. More individuals in the medication group had conjunctival hyperaemia and eyelid erythema compared with SLT at 24 months.
CONCLUSION


Overall, we did not find evidence that SLT was superior to medication in improving glaucoma-specific QoL. While we found superior IOP reduction in the medication arm, eyelid erythema and conjunctival hyperaemia were more prevalent in these patients compared with the SLT group.
TRIAL REGISTRATION


ACTRN12611000720910.",2020,"More individuals in the medication group had conjunctival hyperaemia and eyelid erythema compared with SLT at 24 months.
","['initial glaucoma treatment', '167 enrolled patients, 83 and 84 were randomised to SLT and topical medication, respectively; and 145 ', 'naïve mild-to-moderate primary open angle or exfoliation glaucoma patients']","['SLT', 'SLT or topical medication', 'selective laser trabeculoplasty (SLT', 'Selective laser trabeculoplasty versus topical medication']","['social well-being', 'eyelid erythema and conjunctival hyperaemia', 'rate of successful IOP reduction', 'GOAT outcomes', 'presence of ocular surface disease including conjunctival hyperaemia and eyelid erythema', 'rate of successful intraocular pressure (IOP) reduction', 'conjunctival hyperaemia and eyelid erythema', 'superior IOP reduction']","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0429524', 'cui_str': 'Angle open (finding)'}, {'cui': 'C0206368', 'cui_str': 'Glaucoma Capsulare'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}]","[{'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia (finding)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1510458', 'cui_str': 'Capras'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",167.0,0.147107,"More individuals in the medication group had conjunctival hyperaemia and eyelid erythema compared with SLT at 24 months.
","[{'ForeName': 'Ghee Soon', 'Initials': 'GS', 'LastName': 'Ang', 'Affiliation': 'Glaucoma Investigation and Research Unit, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Eva K', 'Initials': 'EK', 'LastName': 'Fenwick', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alfred Tau Liang', 'Initials': 'ATL', 'LastName': 'Gan', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Ryan Eyn Kidd', 'Initials': 'REK', 'LastName': 'Man', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Casson', 'Affiliation': 'Ophthalmology and Visual Sciences, South Australian Institute of Ophthalmology, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Goldberg', 'Affiliation': 'Discipline of Ophthalmology, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Healey', 'Affiliation': 'Discipline of Ophthalmology, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Pesudovs', 'Affiliation': 'School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sutha', 'Initials': 'S', 'LastName': 'Sanmugasundram', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'McIntosh', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Jackson', 'Affiliation': 'National Vision Research Institute, Australian College of Optometry, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Wells', 'Affiliation': 'Capital Eye Specialists, Wellington, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'White', 'Affiliation': 'Discipline of Ophthalmology, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Glaucoma Investigation and Research Unit, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Walland', 'Affiliation': 'Glaucoma Investigation and Research Unit, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Crowston', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Ecosse Luc', 'Initials': 'EL', 'LastName': 'Lamoureux', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore ecosse@unimelb.edu.au.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313396']
2905,30790211,Reducing bedtime physiological arousal levels using immersive audio-visual respiratory bio-feedback: a pilot study in women with insomnia symptoms.,"Hyperarousal is a critical component of insomnia, particularly at bedtime when individuals are trying to fall asleep. The current study evaluated the effect of a novel, acute behavioral experimental manipulation (combined immersive audio-visual relaxation and biofeedback) in reducing bedtime physiological hyperarousal in women with insomnia symptoms. After a clinical/adaptation polysomnographic (PSG) night, sixteen women with insomnia symptoms had two random-order PSG nights: immersive audio-visual respiratory bio-feedback across the falling asleep period (manipulation night), and no pre-sleep arousal manipulation (control night). While using immersive audio-visual respiratory bio-feedback, overall heart rate variability was increased and heart rate (HR) was reduced (by ~ 5 bpm; p < 0.01), reflecting downregulation of autonomic pre-sleep arousal, relative to no-manipulation. HR continued to be lower during sleep, and participants had fewer awakenings and sleep stage transitions on the manipulation night relative to the control night (p < 0.05). The manipulation did not affect sleep onset latency or other PSG parameters. Overall, this novel behavioral approach targeting the falling asleep process emphasizes the importance of pre-sleep hyperarousal as a potential target for improving sleep and nocturnal autonomic function during sleep in insomnia.",2019,"While using immersive audio-visual respiratory bio-feedback, overall heart rate variability was increased and heart rate (HR) was reduced (by ~ 5 bpm; p < 0.01), reflecting downregulation of autonomic pre-sleep arousal, relative to no-manipulation.","['sixteen women with insomnia symptoms had two random-order PSG nights', 'women with insomnia symptoms']","['novel, acute behavioral experimental manipulation (combined immersive audio-visual relaxation and biofeedback', 'immersive audio-visual respiratory bio-feedback', 'immersive audio-visual respiratory bio-feedback across the falling asleep period (manipulation night), and no pre-sleep arousal manipulation (control night']","['bedtime physiological hyperarousal', 'awakenings and sleep stage transitions', 'immersive audio-visual respiratory bio-feedback, overall heart rate variability', 'heart rate (HR', 'bedtime physiological arousal levels']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",16.0,0.0282431,"While using immersive audio-visual respiratory bio-feedback, overall heart rate variability was increased and heart rate (HR) was reduced (by ~ 5 bpm; p < 0.01), reflecting downregulation of autonomic pre-sleep arousal, relative to no-manipulation.","[{'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'de Zambotti', 'Affiliation': 'Center for Health Sciences, SRI International, 333 Ravenswood Avenue, Menlo Park, CA, 94025, USA. massimiliano.dezambotti@sri.com.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Sizintsev', 'Affiliation': 'Center for Vision Technologies, SRI International, Princeton, NJ, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Claudatos', 'Affiliation': 'Center for Health Sciences, SRI International, 333 Ravenswood Avenue, Menlo Park, CA, 94025, USA.'}, {'ForeName': 'Giacinto', 'Initials': 'G', 'LastName': 'Barresi', 'Affiliation': 'Department of Advanced Robotics, Istituto Italiano di Tecnologia, Genoa, Italy.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Colrain', 'Affiliation': 'Center for Health Sciences, SRI International, 333 Ravenswood Avenue, Menlo Park, CA, 94025, USA.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Baker', 'Affiliation': 'Center for Health Sciences, SRI International, 333 Ravenswood Avenue, Menlo Park, CA, 94025, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00020-9']
2906,31103580,Randomized Trial Comparing Transdermal With Sublingual Nitroglycerin Administration for Coronary Vasodilation in CTA.,,2019,,['Coronary Vasodilation in CTA'],['Sublingual Nitroglycerin'],[],"[{'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}]","[{'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}]",[],,0.0446488,,"[{'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Scholtz', 'Affiliation': ''}, {'ForeName': 'Vinit', 'Initials': 'V', 'LastName': 'Baliyan', 'Affiliation': ''}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Hedgire', 'Affiliation': ''}, {'ForeName': 'Nathaniel D', 'Initials': 'ND', 'LastName': 'Mercaldo', 'Affiliation': ''}, {'ForeName': 'Theodore T', 'Initials': 'TT', 'LastName': 'Pierce', 'Affiliation': ''}, {'ForeName': 'Gabriela Zagarodne S', 'Initials': 'GZS', 'LastName': 'Missine', 'Affiliation': ''}, {'ForeName': 'Nandini M', 'Initials': 'NM', 'LastName': 'Meyersohn', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Stockton', 'Affiliation': ''}, {'ForeName': 'Travis L', 'Initials': 'TL', 'LastName': 'Redel', 'Affiliation': ''}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'McNulty', 'Affiliation': ''}, {'ForeName': 'Cristy', 'Initials': 'C', 'LastName': 'Savage', 'Affiliation': ''}, {'ForeName': 'Russel J', 'Initials': 'RJ', 'LastName': 'Roberts', 'Affiliation': ''}, {'ForeName': 'Borek', 'Initials': 'B', 'LastName': 'Foldyna', 'Affiliation': ''}, {'ForeName': 'Richard A P', 'Initials': 'RAP', 'LastName': 'Takx', 'Affiliation': ''}, {'ForeName': 'Sahani', 'Initials': 'S', 'LastName': 'Dushyant', 'Affiliation': ''}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': ''}, {'ForeName': 'Brian B', 'Initials': 'BB', 'LastName': 'Ghoshhajra', 'Affiliation': ''}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2019.02.027']
2907,31126887,Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial.,"OBJECTIVES


This study sought to assess the efficacy and safety of a drug-coated balloon (DCB) strategy versus drug-eluting stent (DES) in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI).
BACKGROUND


In primary percutaneous coronary intervention for STEMI, stenting has proved to be beneficial with regard to repeat revascularization, but not recurrent myocardial infarction or death, compared with balloon angioplasty alone. A strategy of DCB angioplasty without stenting might abolish the potential disadvantages of stent implantation while reducing the probability of restenosis observed in plain old balloon angioplasty.
METHODS


In the prospective, randomized, single-center REVELATION trial, we compared DCB with DES in patients presenting with STEMI. Patients with a new, nonseverely calcified culprit lesion in a native coronary artery and a residual stenosis of <50% after pre-dilatation were randomized to treatment with a DCB or DES. The primary endpoint was fractional flow reserve at 9 months, allowing for a functional measurement of the infarct-related lesion.
RESULTS


A total of 120 patients were included. At 9 months after enrolment, the mean fractional flow reserve value was 0.92 ± 0.05 in the DCB group (n = 35) and 0.91 ± 0.06 in the DES group (n = 38) (p = 0.27). One abrupt vessel closure requiring treatment occurred after treatment with DCB. Up to 9-months follow-up, 2 patients required nonurgent target lesion revascularization (1 in each group).
CONCLUSIONS


In the setting of STEMI, the DCB strategy was noninferior to DES in terms of fractional flow reserve assessed at 9 months. Furthermore, it seemed to be a safe and feasible strategy. (Revascularization With Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stenting in Acute Myocardial Infarction [REVELATION]; NCT02219802).",2019,"In the setting of STEMI, the DCB strategy was noninferior to DES in terms of fractional flow reserve assessed at 9 months.","['patients presenting with STEMI', 'Myocardial Infarction', 'A total of 120 patients were included', 'Patients with a new, nonseverely calcified culprit lesion in a native coronary artery and a residual stenosis of\xa0<50% after pre-dilatation', 'Acute', 'Acute Myocardial Infarction [REVELATION']","['DCB or DES', 'DCB', 'Paclitaxel-Coated Balloon Angioplasty', 'Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent', 'Drug-Eluting Stenting', 'DCB angioplasty without stenting', 'drug-coated balloon (DCB) strategy versus drug-eluting stent (DES']","['nonurgent target lesion revascularization', 'mean fractional flow reserve value', 'fractional flow reserve at 9\xa0months, allowing for a functional measurement of the infarct-related lesion', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",120.0,0.0904456,"In the setting of STEMI, the DCB strategy was noninferior to DES in terms of fractional flow reserve assessed at 9 months.","[{'ForeName': 'Nicola S', 'Initials': 'NS', 'LastName': 'Vos', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Nick D', 'Initials': 'ND', 'LastName': 'Fagel', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Amoroso', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Jean-Paul R', 'Initials': 'JR', 'LastName': 'Herrman', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Patterson', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Lieuwe H', 'Initials': 'LH', 'LastName': 'Piers', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'René J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Slagboom', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Maarten A', 'Initials': 'MA', 'LastName': 'Vink', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands. Electronic address: m.a.vink@olvg.nl.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.04.016']
2908,31250540,Efficacy of two different doses of oral vitamin D supplementation on inflammatory biomarkers and maternal and neonatal outcomes.,"Hypovitaminosis D during pregnancy is suggested to have a link with complications in both mother and infant. We aimed to evaluate the efficacy of two doses of vitamin D3 supplementation during pregnancy on maternal and cord blood vitamin D status, inflammatory biomarkers, and maternal and neonatal outcomes. A total of 84 pregnant women (gestational age of <12 weeks) were randomly allocated to one of two groups: (a) 1,000-IU/d vitamin D and (b) 2,000 IU/d. Biochemical assessments (25-hydroxycalciferol (25(OH)D), hs-CRP, and cell-culture supernatant concentrations of IL-1β, IL-6, and TNF-α) of mothers were performed at the beginning and 34 weeks of gestation. Assessments of infants at delivery comprised cord blood serum concentrations of 25(OH)D, hs-CRP, IL-1β, IL-6, TNF-α, birth sizes, and Apgar score. Circulating concentrations of 25(OH)D increased in both intervention groups with more increment in 2,000 IU/d than in 1,000 IU/d (46.7 ± 30.7 vs. 24.0 ± 21.07 nmol L -1  , P = .001). Concentrations of TNF-α decreased significantly in group 2,000 (-913.1 ± 1261.3 ng L -1  , P = .01). The cord blood concentration of IL-6 in group 2,000 IU/d, compared with 1,000 IU/d, was significantly lower (25.9 ± 32.0 vs. 4.6 ± 1.4 ng L -1  , P = .03). The birth sizes including weight, length, and head circumference of the infants of group 2,000 IU/d were significantly higher than the infants' of group 1,000 IU/d. Supplementation with 2,000-IU/d vitamin D3 is more effective than 1,000 IU/d in pregnant women in terms of increasing circulating 25(OH)D, ameliorating pro-inflammatory markers notably TNF-α in mother and IL-6 in cord blood, and improving neonatal outcomes including the birth sizes.",2019,"Concentrations of TNF-α decreased significantly in group 2000 (-913.1±1261.3 ng/L, p=0.01).","['84 pregnant women (gestational age of <12 weeks', 'pregnant women']","['oral vitamin D supplementation', 'd vitamin D3', 'vitamin D3 supplementation']","['Biochemical assessments (25-hydroxycalciferol (25(OH)D), hs-CRP and cell-culture supernatant concentrations of IL-1β, IL-6 and TNF-α', 'maternal and cord blood vitamin D status, inflammatory biomarkers and maternal and neonatal outcomes', 'cord blood concentration of IL-6', 'Circulating concentrations of 25(OH)D', 'cord blood serum concentrations of 25(OH)D, hs-CRP, IL-1β, IL-6, TNF-α, birth sizes and Apgar score', 'weight, length and head circumference', 'Concentrations of TNF-α', 'inflammatory biomarkers, and maternal and neonatal outcomes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0000343', 'cui_str': '25-Hydroxycalciferol'}, {'cui': 'C0007585', 'cui_str': 'Cell Culture Techniques'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}]",84.0,0.0958387,"Concentrations of TNF-α decreased significantly in group 2000 (-913.1±1261.3 ng/L, p=0.01).","[{'ForeName': 'Soudabe', 'Initials': 'S', 'LastName': 'Motamed', 'Affiliation': 'Department of Nutrition, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Nikooyeh', 'Affiliation': 'Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kashanian', 'Affiliation': 'Department of Obstetrics and Gynecology, Akbarabadi Teaching Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Tirang R', 'Initials': 'TR', 'LastName': 'Neyestani', 'Affiliation': 'Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Maternal & child nutrition,['10.1111/mcn.12867']
2909,31422087,"Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents: 3-Year Outcomes of BIO-RESORT.","OBJECTIVES


The aim of this study was to assess the 3-year safety and efficacy of treating all-comer patients with 3 contemporary drug-eluting stents (DES).
BACKGROUND


The BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) (TWENTE III) randomized trial (NCT01674803) found similar 1-year safety and efficacy for the 2 biodegradable-polymer DES (i.e., ultrathin-strut cobalt-chromium Orsiro sirolimus-eluting stent [SES] and very-thin-strut platinum-chromium Synergy everolimus-eluting stent) compared with the durable-polymer thin-strut cobalt-chromium Resolute Integrity zotarolimus-eluting stent (ZES). Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES.
METHODS


A total of 3,514 all-comer patients were treated at 4 centers for coronary intervention. The main clinical endpoint, target vessel failure, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularization). Secondary endpoints included the individual components of target vessel failure and stent thrombosis.
RESULTS


Three-year follow-up data were available for 3,393 of 3,514 patients (96.6%). Target vessel failure occurred in 8.5% with SES and 10.0% with ZES (p log rank  = 0.22) and in 8.8% with everolimus-eluting stents (vs. ZES, p log rank  = 0.32). Rates of cardiac death, target vessel myocardial infarction, and target vessel revascularization were similar between stent groups. Landmark analyses found no statistically significant between-stent difference in repeat revascularization between 1 and 3 years. Definite or probable stent thrombosis rates were low (SES, 1.1%; everolimus-eluting stent, 1.1%; ZES, 0.9%) and similar with all 3 DES.
CONCLUSIONS


Despite substantial differences in stent backbone and polymer coating, all 3 DES showed favorable 3-year safety and efficacy in all comers, without significant between-stent differences. Further follow-up is required to definitely answer the question of whether one stent might improve clinical outcomes at a later stage.",2019,"Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES.
","['patients with 3 contemporary drug-eluting stents (DES', 'A total of 3,514 all-comer patients were treated at 4 centers for coronary intervention']","['durable-polymer thin-strut cobalt-chromium Resolute Integrity zotarolimus-eluting stent (ZES', 'SES', 'Ultrathin Strut Biodegradable- or Durable-Polymer-Coated Drug-Eluting Stents', 'ZES', '2 biodegradable-polymer DES (i.e., ultrathin-strut cobalt-chromium Orsiro sirolimus-eluting stent [SES] and very-thin-strut platinum-chromium Synergy everolimus-eluting stent']","['composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularization', 'repeat revascularization', 'Definite or probable stent thrombosis rates', 'Rates of cardiac death, target vessel myocardial infarction, and target vessel revascularization', 'Target vessel failure', 'favorable 3-year safety and efficacy', '3-year safety and efficacy', 'individual components of target vessel failure and stent thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C1700035', 'cui_str': 'zotarilumus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",3514.0,0.0438463,"Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES.
","[{'ForeName': 'Rosaly A', 'Initials': 'RA', 'LastName': 'Buiten', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Eline H', 'Initials': 'EH', 'LastName': 'Ploumen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zocca', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Carine J M', 'Initials': 'CJM', 'LastName': 'Doggen', 'Affiliation': 'Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Danse', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'Department of Cardiology, Haga Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Scholte', 'Affiliation': 'Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'K Gert', 'Initials': 'KG', 'LastName': 'van Houwelingen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Stoel', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hartmann', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'R Melvyn', 'Initials': 'RM', 'LastName': 'Tjon Joe Gin', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Somi', 'Affiliation': 'Department of Cardiology, Haga Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Gerard C M', 'Initials': 'GCM', 'LastName': 'Linssen', 'Affiliation': 'Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, the Netherlands.'}, {'ForeName': 'Marlies M', 'Initials': 'MM', 'LastName': 'Kok', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands. Electronic address: c.vonbirgelen@mst.nl.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.04.054']
2910,31422088,Everolimus-Eluting Biodegradable Polymer Versus Everolimus-Eluting Durable Polymer Stent for Coronary Revascularization in Routine Clinical Practice.,"OBJECTIVES


The aim of this study was to compare the efficacy and safety of a thin-strut, biodegradable-polymer everolimus-eluting stent (BP-EES) (Synergy, Boston Scientific, Marlborough, Massachusetts) and a thin-strut, durable-polymer everolimus-eluting stent (DP-EES) (XIENCE, Abbott Vascular, Abbott Park, Illinois) in an all-comers population.
BACKGROUND


BP-EES have been shown to be noninferior to DP-EES in randomized trials in patients at low to moderate risk.
METHODS


Among 7,042 consecutive patients who underwent percutaneous coronary intervention between December 2012 and December 2016, 3,870 patients were exclusively treated with BP-EES (n = 1,343) or with DP-EES (n = 2,527). After propensity score matching, the final study population consisted of 1,041 matched patients. The primary endpoint was the device-oriented composite endpoint (cardiac death, target vessel myocardial infarction, and target lesion revascularization) at 12 months.
RESULTS


The device-oriented composite endpoint did not differ between the 2 groups (7.8% with BP-EES vs. 7.1% with DP-EES; hazard ratio: 1.12; 95% confidence interval: 0.81 to 1.53; p = 0.49). There were no differences in rates of cardiac death (3.0% vs. 3.0%; p = 1.00), target vessel myocardial infarction (3.6% vs. 3.1%; p = 0.53), and target lesion revascularization (3.0% vs. 2.5%; p = 0.41). The rate of acute stent thrombosis was significantly higher in the BP-EES group compared with the DP-EES group (1.2% vs. 0.3%; hazard ratio: 4.00; 95% confidence interval: 1.13 to 14.19; p = 0.032). At 12 months, the frequency of definite stent thrombosis did not differ (1.5% vs. 0.9%; hazard ratio: 1.67; 95% confidence interval: 0.73 to 3.82; p = 0.22).
CONCLUSIONS


In this consecutively enrolled percutaneous coronary intervention population reflecting routine clinical practice, no difference in the device-oriented composite endpoint between BP-EES and DP-EES was observed throughout 12 months. There was a higher rate of acute stent thrombosis with the BP-EES, a difference that disappeared at 1 year. (CARDIOBASE Bern PCI Registry; NCT02241291).",2019,The rate of acute stent thrombosis was significantly higher in the BP-EES group compared with the DP-EES group (1.2% vs. 0.3%; hazard ratio: 4.00; 95% confidence interval: 1.13 to 14.19; p = 0.032).,"['1,041 matched patients', '7,042 consecutive patients who underwent percutaneous coronary intervention between December 2012 and December 2016', 'patients at low to moderate risk', 'Coronary\xa0Revascularization in Routine', '3,870 patients were exclusively treated with']","['Everolimus-Eluting Biodegradable Polymer Versus Everolimus-Eluting Durable Polymer Stent', 'BP-EES', 'thin-strut, biodegradable-polymer everolimus-eluting stent (BP-EES; Synergy) and a thin-strut, durable-polymer everolimus-eluting stent (DP-EES; XIENCE', 'DP-EES']","['frequency of definite stent thrombosis', 'target lesion revascularization', 'target vessel myocardial infarction', 'efficacy and safety', 'device-oriented composite endpoint (cardiac death, target vessel myocardial infarction, and target lesion revascularization', 'rates of cardiac death', 'rate of acute stent thrombosis', 'BP-EES and DP-EES']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}]",3870.0,0.160936,The rate of acute stent thrombosis was significantly higher in the BP-EES group compared with the DP-EES group (1.2% vs. 0.3%; hazard ratio: 4.00; 95% confidence interval: 1.13 to 14.19; p = 0.032).,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Zanchin', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Ueki', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zanchin', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Häner', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Tatsuhiko', 'Initials': 'T', 'LastName': 'Otsuka', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Stortecky', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Konstantinos C', 'Initials': 'KC', 'LastName': 'Koskinas', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'George C M', 'Initials': 'GCM', 'LastName': 'Siontis', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Praz', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Moschovitis', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Hunziker', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pilgrim', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: lorenz.raeber@insel.ch.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.04.046']
2911,32433827,Pain over 2 years after start of biological versus conventional combination treatment in early rheumatoid arthritis: results from the randomised controlled SWEFOT trial.,"OBJECTIVE


To compare the pain course between methotrexate (MTX)-refractory early rheumatoid arthritis (RA) patients randomised to infliximab (IFX) versus sulfasalazine+hydroxychloroquine (SSZ+HCQ).
METHODS


The randomised, controlled, open-label SWEFOT (SWedish FarmacOTherapy) trial enrolled new-onset RA patients Oct 2002-Dec 2005. After 3 months on MTX, patients not reaching low disease activity (28-joint Disease Activity Score; DAS28≤3.2) were randomised to adding IFX (n=128) or SSZ+HCQ (n=130) and followed for 21 months. Here, outcomes included area-under-the-curve (AUC) for Visual Analogue Scale (VAS) of pain, unacceptable pain (VAS pain>40mm [0-100]); and unacceptable pain despite inflammation control (refractory pain; VAS pain>40+C-reactive protein<10mg/L). Between-group differences were analysed with multivariate regression models.
RESULTS


Overall, 50% of randomised patients (n=258) in the crude setting, reported unacceptable pain at randomisation, declining to 29% at 21 months (p<0.001), when refractory pain constituted 82% of all unacceptable pain. Comparing randomised arms (intention-to-treat analysis), AUC for VAS pain was lower in the MTX+IFX-group (p=0.01), and at 21 months 32% with MTX+IFX and 45% with MTX+SSZ+HCQ had unacceptable pain (adjusted relative risk 0.68 [95%CI:0.51-0.90]; p=0.008). Regarding refractory pain, no between-group differences were observed.
CONCLUSION


Despite active combination treatment, almost 1/3 of new-onset RA patients reported unacceptable pain after 21 months and refractory pain constituted more than 4/5 of this pain load. Adding IFX versus SSZ+HCQ to MTX reduced both cumulative pain and unacceptable pain at 21 months, suggesting less long-term pain for the biological therapy. These results display insufficient effects of current treatment strategies on inflammation-independent pain components, warranting alternative approaches in affected patients.",2020,"Overall, 50% of randomised patients (n=258) in the crude setting, reported unacceptable pain at randomisation, declining to 29% at 21 months (p<0.001), when refractory pain constituted 82% of all unacceptable pain.","['MTX)-refractory early rheumatoid arthritis (RA) patients', 'early rheumatoid arthritis', 'RA patients Oct 2002-Dec 2005']","['SSZ+HCQ', 'MTX+SSZ+HCQ', 'MTX+IFX', 'biological versus conventional combination treatment', 'IFX', 'methotrexate', 'MTX', 'infliximab (IFX) versus sulfasalazine+hydroxychloroquine (SSZ+HCQ', 'IFX versus SSZ+HCQ to MTX']","['area-under-the-curve (AUC) for Visual Analogue Scale (VAS) of pain, unacceptable pain (VAS pain>40mm [0-100]); and unacceptable pain despite inflammation control (refractory pain; VAS pain>40+C-reactive protein<10mg/L', 'AUC for VAS pain', 'Pain', 'pain course', 'unacceptable pain', 'refractory pain', 'cumulative pain and unacceptable pain']","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030200', 'cui_str': 'Refractory Pain'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]",,0.362198,"Overall, 50% of randomised patients (n=258) in the crude setting, reported unacceptable pain at randomisation, declining to 29% at 21 months (p<0.001), when refractory pain constituted 82% of all unacceptable pain.","[{'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Olofsson', 'Affiliation': 'Lund University, Skåne University Hospital, Department of Clinical Sciences Lund, Rheumatology, Lund, Sweden.'}, {'ForeName': 'Johan K', 'Initials': 'JK', 'LastName': 'Wallman', 'Affiliation': 'Lund University, Skåne University Hospital, Department of Clinical Sciences Lund, Rheumatology, Lund, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jöud', 'Affiliation': 'Lund University, Department of Laboratory medicine, Division of Occupational and Environmental Medicine, Lund, Sweden.'}, {'ForeName': 'Maria Ec', 'Initials': 'ME', 'LastName': 'Schelin', 'Affiliation': 'Lund University, Department of Clinical Sciences Lund, Oncology, Lund, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Ernestam', 'Affiliation': 'Academic Specialist Centre, Stockholm Health Services, Stockholm, Sweden.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'van Vollenhoven', 'Affiliation': 'Karolinska Institutet, Department of Medicine Solna, Rheumatology Unit, Stockholm, Sweden.'}, {'ForeName': 'Saedis', 'Initials': 'S', 'LastName': 'Saevarsdottir', 'Affiliation': 'Karolinska Institutet, Department of Medicine Solna, Rheumatology Unit, Stockholm, Sweden.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Lampa', 'Affiliation': 'Karolinska Institutet, Department of Medicine Solna, Rheumatology Unit, Stockholm, Sweden.'}]",Arthritis care & research,['10.1002/acr.24264']
2912,31449880,"Design and participant characteristics of TX sprouts: A school-based cluster randomized gardening, nutrition, and cooking intervention.","AIMS


To outline the study design, outcome measures, protocol and baseline characteristics of enrolled participants of Texas (TX) Sprouts, a one-year school-based gardening, nutrition, and cooking cluster randomized trial.
METHODS


Eight schools were randomly assigned to the TX Sprouts intervention and eight schools to the delayed intervention over three years (2016-2019). The intervention arm received: formation/training of Garden Leadership Committees; a 0.25-acre outdoor teaching garden; 18 student lessons including gardening, nutrition, and cooking activities, taught weekly during school hours by hired educators throughout one school year; and nine parent lessons taught monthly to families. The delayed intervention was implemented the following academic year and received the same protocol as the intervention arm. Primary outcomes included: dietary intake, dietary-related behaviors, obesity, and metabolic parameters. Child measures included: height, weight, waist circumference, body composition, blood pressure, and dietary psychosocial variables. A subsample of children were measured for glucose, hemoglobin-A1C, and 24-hour dietary recalls. Parent measures included: height and weight, dietary intake, and related dietary psychosocial variables.
RESULTS


Of the 4239 eligible students, 3137 students consented and provided baseline clinical measures; 3132 students completed child surveys, with 92% of their parents completing parent surveys. The subsamples of blood draws and dietary recalls were 34% and 24%, respectively. Intervention arm baseline descriptives, clinical and dietary data for children and parents are reported.
CONCLUSION


The TX Sprouts intervention targeted primarily low-income Hispanic children and their parents; utilized an interactive gardening, nutrition, and cooking program; and measured a battery of dietary behaviors, obesity and metabolic outcomes.",2019,"A subsample of children were measured for glucose, hemoglobin-A1C, and 24-hour dietary recalls.","['3137 students consented and provided baseline clinical measures; 3132 students completed child surveys, with 92% of their parents completing parent surveys', 'Eight schools', 'enrolled participants of Texas (TX) Sprouts, a one-year school-based gardening, nutrition, and cooking cluster randomized trial', '4239 eligible students']","['TX Sprouts intervention and eight schools to the delayed intervention', 'formation/training of Garden Leadership Committees; a 0.25-acre outdoor teaching garden; 18 student lessons including gardening, nutrition, and cooking activities, taught weekly during school hours by hired educators throughout one school year; and nine parent lessons taught monthly to families']","['height, weight, waist circumference, body composition, blood pressure, and dietary psychosocial variables', 'glucose, hemoglobin-A1C, and 24-hour dietary recalls', 'height and weight, dietary intake, and related dietary psychosocial variables', 'dietary intake, dietary-related behaviors, obesity, and metabolic parameters', 'blood draws and dietary recalls']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4019428', 'cui_str': 'Gardens'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0560271', 'cui_str': 'acre (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}]",,0.0246201,"A subsample of children were measured for glucose, hemoglobin-A1C, and 24-hour dietary recalls.","[{'ForeName': 'JaimieN', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA. Electronic address: Jaimie.davis@austin.utexas.edu.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Nikah', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Asigbee', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Landry', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Sarvenaz', 'Initials': 'S', 'LastName': 'Vandyousefi', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Ghaddar', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hoover', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jeans', 'Affiliation': 'Department of Nutritional Sciences, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Pont', 'Affiliation': 'Department of Pediatrics, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'Texas A&M AgriLife Extension Service, Travis County, USA.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Hoelscher', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Health Promotion and Behavioral Sciences, UTHealth School of Public Health, Austin Campus, Austin, USA.'}, {'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Van Den Berg', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Health Promotion and Behavioral Sciences, UTHealth School of Public Health, Austin Campus, Austin, USA.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Bluestein', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Biostatistics and Data Science, University of Texas Health (UTHealth) Science Center, Austin Regional Campus, Austin, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Pérez', 'Affiliation': 'Michael & Susan Dell Center for Healthy Living, Department of Biostatistics and Data Science, University of Texas Health (UTHealth) Science Center, Austin Regional Campus, Austin, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105834']
2913,31298268,"Development and acceptability of a peer-paired, cross-cultural and cross-generational storytelling HPV intervention for Korean American college women.","Although Korean American women have a higher risk of developing cervical cancer, currently there are limited culturally relevant intervention strategies for improving primary prevention of cervical cancer by promoting HPV vaccination in this population. This study reports the development of a cross-cultural, cross-generational storytelling HPV intervention using a peer-paired method, in which two storytellers interactively share their stories, as a particular innovation that might resonate with Korean American young women. The acceptability of the intervention was assessed by self-reported satisfaction and endorsement with the intervention in a pilot randomized control trial (RCT). We compared participants' responses to the intervention by their generation and cultural identity. One hundred and four Korean college women between the ages of 18-26 were recruited from the Northeastern US Participants randomized to the intervention group received a storytelling video (n = 54); the comparison group received written information (n = 50). The acceptability of the intervention was measured immediately post-intervention. The intervention group had significantly greater satisfaction than the comparison group (P < 0.05). Participants reported greater endorsement for videos that reflected their cultural and generational experiences. Future study is needed to examine the impact of such interventions on objective follow-up on HPV vaccination in a large-scale RCT.",2019,The intervention group had significantly greater satisfaction than the comparison group (P < 0.05).,"['One hundred and four Korean college women between the ages of 18-26', 'Korean American young women', 'Korean American women', 'Korean American college women']","['peer-paired, cross-cultural and cross-generational storytelling HPV intervention', 'storytelling video (n = 54); the comparison group received written information']",['greater satisfaction'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0597921', 'cui_str': 'Korean Americans'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",104.0,0.0406841,The intervention group had significantly greater satisfaction than the comparison group (P < 0.05).,"[{'ForeName': 'Minjin', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Division of Preventive Medicine and Behavior, Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School.'}, {'ForeName': 'Haeok', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College of Nursing and Health Sciences, University of Massachusetts Boston.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kiang', 'Affiliation': 'School for Global Inclusion and Social Development, University of Massachusetts Boston.'}, {'ForeName': 'Jeroan', 'Initials': 'J', 'LastName': 'Allison', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.'}]",Health education research,['10.1093/her/cyz022']
2914,31486406,"A Digital Intervention Addressing Alcohol Use Problems (the ""Daybreak"" Program): Quasi-Experimental Randomized Controlled Trial.","BACKGROUND


Alcohol use is prevalent in many societies and has major adverse impacts on health, but the availability of effective interventions limits treatment options for those who want assistance in changing their patterns of alcohol use.
OBJECTIVE


This study evaluated the new Daybreak program, which is accessible via mobile app and desktop and was developed by Hello Sunday Morning to support high-risk drinking individuals looking to change their relationship with alcohol. In particular, we compared the effect of adding online coaching via real-time chat messages (intervention group) to an otherwise self-guided program (control group).
METHODS


We designed the intervention as a randomized control trial, but as some people (n=48; 11.9%) in the control group were able to use the online coaching, the main analysis comprised all participants. We collected online surveys at one-month and three-months follow-up. The primary outcome was change in alcohol risk (measured with the alcohol use disorders identification test-consumption [AUDIT-C] score), but other outcomes included the number of standard drinks per week, alcohol-related days out of role, psychological distress (Kessler-10), and quality of life (EUROHIS-QOL). Markers of engagement with the program included posts to the site and comments on the posts of others. The primary analysis used Weighted Generalized Estimating Equations.
RESULTS


We recruited 398 people to the intervention group (50.2%) and 395 people to the control group (49.8%). Most were female (71%) and the mean age was 40.1 years. Most participants were classified as probably dependent (550, 69%) on the AUDIT-10, with 243 (31%) classified with hazardous or harmful consumption. We followed up with 334 (42.1%) participants at one month and 293 (36.9%) at three months. By three months there were significant improvements in AUDIT-C scores (down from mean 9.1 [SD 1.9] to 5.8 [SD 3.1]), alcohol consumed per week (down from mean 37.1 [SD 28.3] to mean 17.5 [SD 18.9]), days out of role (down from mean 1.6 [SD 3.6] to 0.5 [SD 1.6]), quality of life (up from 3.2 [SD 0.7] to 3.6 [SD 0.7]) and reduced distress (down from 24.8 [SD 7.0] to 19.0 [SD 6.6]). Accessing online coaching was not associated with improved outcomes, but engagement with the program (eg, posts and comments on the posts of others) were significantly associated with improvements (eg, in AUDIT-C, alcohol use and EUROHIS-QOL). Reduced alcohol use was found for both probably dependent (estimated marginal mean of 40.8 to 20.1 drinks) and hazardous or harmful alcohol users (estimated marginal mean of 22.9 to 11.9 drinks).
CONCLUSIONS


Clinically significant reductions in alcohol use were found, as well as reduced alcohol risk (AUDIT-C) and days out of role. Importantly, improved alcohol-related outcomes were found for both hazardous or harmful and probably dependent drinkers. Since October 2016, Daybreak has reached more than 50,000 participants. Therefore, there is the potential for the program to have an impact on alcohol-related problems at a population health level, importantly including an effect on probably dependent drinkers.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry: ACTRN12618000010291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373110.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/9982.",2019,"Clinically significant reductions in alcohol use were found, as well as reduced alcohol risk (AUDIT-C) and days out of role.","['50,000 participants', '398 people to the intervention group (50.2%) and 395 people to the control group (49.8', 'Most participants were classified as probably dependent (550, 69%) on the AUDIT-10, with 243 (31%) classified with hazardous or harmful consumption', 'Australian New Zealand Clinical Trials Registry', 'Most were female (71%) and the mean age was 40.1 years', 'people (n=48; 11.9%) in the control group']",['online coaching via real-time chat messages (intervention group) to an otherwise self-guided program (control group'],"['reduced distress', 'AUDIT-C scores', 'quality of life', 'change in alcohol risk (measured with the alcohol use disorders identification test-consumption [AUDIT-C] score', 'number of standard drinks per week, alcohol-related days out of role, psychological distress (Kessler-10), and quality of life (EUROHIS-QOL', 'Reduced alcohol use']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0946707', 'cui_str': 'Chat'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test (assessment scale)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]",398.0,0.0985385,"Clinically significant reductions in alcohol use were found, as well as reduced alcohol risk (AUDIT-C) and days out of role.","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Tait', 'Affiliation': 'National Drug Research Institute, Faculty of Health Sciences, Curtin University, Perth, Australia.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Paz Castro', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jessica Jane Louise', 'Initials': 'JJL', 'LastName': 'Kirkman', 'Affiliation': 'Hello Sunday Morning, Sydney, Australia.'}, {'ForeName': 'Jamie Christopher', 'Initials': 'JC', 'LastName': 'Moore', 'Affiliation': 'Hello Sunday Morning, Sydney, Australia.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}]",Journal of medical Internet research,['10.2196/14967']
2915,31450138,Less memory complaints with reduced stimulus dose during electroconvulsive therapy for depression.,"BACKGROUND


Electroconvulsive therapy (ECT) is an effective treatment for depression, but there is risk of cognitive adverse events. This risk has been partially attributed to electrical charge, thus the optimal electrical stimulus dose is still under discussion. The aim of this study was to evaluate how the risk of subjective memory worsening was changed after lowering stimulus dose during ECT for patients with major depression.
METHOD


A retrospective register-based intervention study of the effects of reduced electrical charges for patients receiving ECT for depression was conducted. The primary outcome was subjective memory worsening and the secondary outcome change in effect on depressive symptoms.
RESULTS


A total of 154 patients were enrolled in the study (High dosage group: n = 57; Lower dosage group: n = 97). Subjective memory worsening after ECT occurred in 44% of patients in the high dosage group and in 25% of patients in the lower dosage group(p = 0.014). There was no significant between-group difference in the anti-depressive effect of ECT.
LIMITATIONS


The study was register-based and the two groups were not randomized. A large portion of patients were initially excluded due to missing data in the register. The study lacks a long-term follow up.
CONCLUSION


After implementing a change of treatment protocol, that lowered ECT stimulus doses from high to moderate, the occurrence of subjective memory worsening was significantly reduced without compromising treatment results.",2019,Subjective memory worsening after ECT occurred in 44% of patients in the high dosage group and in 25% of patients in the lower dosage group(p = 0.014).,"['154 patients were enrolled in the study (High dosage group: n\u202f=\u202f57; Lower dosage group: n\u202f=\u202f97', 'patients receiving ECT for depression was conducted', 'patients with major depression']","['Electroconvulsive therapy (ECT', 'electroconvulsive therapy']","['Subjective memory worsening after ECT', 'depressive symptoms', 'subjective memory worsening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",154.0,0.048525,Subjective memory worsening after ECT occurred in 44% of patients in the high dosage group and in 25% of patients in the lower dosage group(p = 0.014).,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kronsell', 'Affiliation': 'Psykiatri Nordväst, Stockholm County Council. Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Stockholm County Council. Centrum för psykiatriforskning, Norra Stationsgatan 69, SE-113 64 Stockholm, Sweden. Electronic address: alexander.kronsell@sll.se.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Nordenskjöld', 'Affiliation': 'Faculty of Medicine and Health, Örebro University.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Tiger', 'Affiliation': 'Department of Clinical Neuroscience, Center for Psychiatry Research, Karolinska Institutet and Stockholm County Council.'}]",Journal of affective disorders,['10.1016/j.jad.2019.08.064']
2916,32433830,A preeclampsia risk prediction model for Chinese pregnant patients with systemic lupus erythematosus.,"OBJECTIVE


To screen for a high risk of preeclampsia (PE) in women with systemic lupus erythematosus (SLE).
METHODS


Five hundred thirteen antenatal care records of pregnant SLE patients were obtained and the data were randomly assigned to either a development set (n=342) or a validation set (n=171). PE predictors were identified with stepwise regression, and coefficient B of each variable was used to establish a prediction model and risk scoring system. Goodness-of-fit was assessed by the Hosmer-Lemeshow and Omnibus tests, and the area under the receiver operating characteristic curve (AUC) was used to assess discrimination. Validation was performed using the validation set.
RESULTS


The PE incidence was 14.4% in the pregnant SLE patients. A mean arterial pressure (MAP) ≥96.5 mmHg (OR 213.15, 95% CI=24.39-999.99), prepregnancy hypertension (OR 18.19, 95% CI=2.67-125.01), a hematological disorder (OR 4.13, 95% CI=1.03-16.67), positive aCL-IgM (OR 19.85, 95% CI=1.11-333.33), serum albumin<31.5 g/L (OR 9.88, 95% CI=2.07-47.62), serum uric acid ≥303 μmol/L (OR 5.58, 95% CI=1.40-22.22) and 24-hour urinary protein ≥0.286 g (OR 14.39, 95% CI=2.43-83.33) were selected for the PE prediction model. The AUC was 0.975. PE prediction model scores>4 indicated a high risk of PE. For the validation set, the PE prediction accuracy was 93.6% (sensitivity=88.5%, specificity=94.5%).
CONCLUSION


A model for predicting the risk of PE in pregnant SLE patients was established on the basis of MAP, prepregnancy hypertension, hematological disorders, aCL-IgM, albumin, uric acid and 24-hour urinary protein. The model had good predictive efficiency and can help clinicians improve pregnancy outcomes in high-risk women with early interventions.",2020,"A mean arterial pressure (MAP) ≥96.5 mmHg (OR 213.15, 95% CI=24.39-999.99), prepregnancy hypertension (OR 18.19, 95% CI=2.67-125.01), a hematological disorder (OR","['women with systemic lupus erythematosus (SLE', 'high-risk women with early interventions', 'Chinese pregnant patients with systemic lupus erythematosus', 'Five hundred thirteen antenatal care records of pregnant SLE patients', 'pregnant SLE patients']",[],"['hematological disorder (OR', 'serum uric acid ≥303 μmol/L', 'prepregnancy hypertension', 'pregnancy outcomes', 'mean arterial pressure', 'PE prediction accuracy', 'PE incidence', 'positive aCL-IgM', '24-hour urinary protein ≥0.286 g (OR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",513.0,0.107083,"A mean arterial pressure (MAP) ≥96.5 mmHg (OR 213.15, 95% CI=24.39-999.99), prepregnancy hypertension (OR 18.19, 95% CI=2.67-125.01), a hematological disorder (OR","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Obstetrics and Gynecology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': 'Department of Rheumatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China.'}, {'ForeName': 'Sihan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Obstetrics and Gynecology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China.'}, {'ForeName': 'Jiayue', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Di', 'Affiliation': 'Department of Obstetrics and Gynecology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China.'}]",Arthritis care & research,['10.1002/acr.24265']
2917,31483750,Application of an innovative high-throughput liquid chromatography-tandem mass spectrometry method for simultaneous analysis of 18 hazardous drugs to rule out accidental acute chemotherapy exposures in health care workers.,"OBJECTIVES


Despite safe handling guidelines published by several groups, health care worker exposure to hazardous drugs continues to occur due to suboptimal engineering controls and low use of protective equipment. Simple, multi-target and specific analytical methods are needed so that acute exposures to these drugs in the workplace can be assessed rapidly. Our aim was to develop an analytical method for simultaneous detection and quantification of widely used cancer drugs to rule out accidental acute chemotherapy exposures in health care workers.
METHODS


We examined the feasibility of alternate high-performance liquid chromatographic-tandem mass spectrometry methods to simultaneously detect eighteen chemotherapy analytes in plasma and urine. The linear concentration ranges tested during assay development were 0.1-50 ng/mL. After development of a multi-analyte assay protocol, plasma samples (n = 743) from a multi-center cluster-randomized clinical trial (n = 12 sites) of an hazardous drug educational intervention were assayed. Confirmatory assays were performed based on the individual acute-spill case-histories.
RESULTS


An innovative HPLC-multiple reaction monitoring-information dependent acquisition-enhanced production ion (MRM-IDA-EPI) analytical method was developed to simultaneously detect: cytarabine, gemcitabine, dacarbazine, methotrexate, topotecan, mitomycin, pemetrexed, irinotecan, doxorubicin, vincristine, vinblastine, ifosamide, cyclophosphamide, vinorelbine, bendamustine, etoposide, docetaxel, and paclitaxel. The retention times ranged from 4 min to 13 min for the analytical run. The limit of detection (MRM-IDA-EPI) and limit of quantitation (MRM) was 0.25 ng/mL and 0.1 ng/mL, respectively for most analytes. No detectable plasma concentrations were measured at baseline, post-intervention and in cases of documented acute spills. Use of a secondary tandem mass spectrometry approach was able to successfully rule out false positive results.
CONCLUSIONS


Development of a sensitive high-throughput multi-analyte cancer chemotherapy assay is feasible using an MRM-IDA-EPI method. This method can be used to rapidly rule out systemic exposure to accidental acute chemotherapy spills in health care workers.",2020,"No detectable plasma concentrations were measured at baseline, post-intervention and in cases of documented acute spills.","['18 hazardous drugs to rule out accidental acute chemotherapy exposures in health care workers', 'accidental acute chemotherapy spills in health care workers']","['innovative high-throughput liquid chromatography-tandem mass spectrometry method', 'hazardous drug educational intervention', 'cytarabine, gemcitabine, dacarbazine, methotrexate, topotecan, mitomycin, pemetrexed, irinotecan, doxorubicin, vincristine, vinblastine, ifosamide, cyclophosphamide, vinorelbine, bendamustine, etoposide, docetaxel, and paclitaxel']","['limit of detection (MRM-IDA-EPI) and limit of quantitation (MRM', 'detectable plasma concentrations']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0521129', 'cui_str': 'Accidental (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0008565', 'cui_str': 'Liquid Chromatography'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C2718050', 'cui_str': 'Limit of Detection'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",743.0,0.0773291,"No detectable plasma concentrations were measured at baseline, post-intervention and in cases of documented acute spills.","[{'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Shu', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wen', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Mendelsohn-Victor', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Duxin', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Friese', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Manjunath P', 'Initials': 'MP', 'LastName': 'Pai', 'Affiliation': 'Department of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.'}]",Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners,['10.1177/1078155219870591']
2918,32433835,"Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care: Phase 3, Randomized, Double-Blind, Active-Control ALPINE Study.","OBJECTIVE


Evaluate efficacy and safety of a 2-month formulation of aripiprazole lauroxil (AL) with 1-day initiation during hospitalization for acute exacerbation of schizophrenia followed by transition to outpatient care.
METHODS


The phase 3b double-blind Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness (ALPINE) study was conducted from November 2017 to March 2019. Adults with acute schizophrenia according to DSM-5 criteria were randomized (1:1) to AL (AL NanoCrystal Dispersion + oral aripiprazole 30 mg, day 1; AL 1,064 mg, day 8 and every 8 weeks [q8wk]) or paliperidone palmitate (PP 234 mg, day 1; PP 156 mg, day 8 and then q4wk) for 25 weeks. Patients remained hospitalized ≥ 2 weeks after randomization per protocol. Primary endpoint was within-group change in Positive and Negative Syndrome Scale total score (PANSST) from baseline to week 4. Secondary analyses included within- and between-group changes from baseline at various time points. Adverse events (AEs) and laboratory data were monitored.
RESULTS


A total of 200 patients were randomized (AL, n = 99; PP, n = 101); 56.6% and 42.6%, respectively, completed the study. For AL, the mean baseline PANSST was 94.1; scores were significantly reduced from baseline at week 4 (-17.4; P < .001) and were also reduced at weeks 9 (-19.8) and 25 (-23.3). With PP, PANSST also improved significantly from baseline (94.6) at week 4 (-20.1; P < .001) and also improved at weeks 9 (-22.5) and 25 (-21.7). The 3 most common AEs over 25 weeks in the AL group were injection site pain (17.2%), increased weight (9.1%), and akathisia (9.1%). The same AEs were the most common in the PP group (injection site pain [24.8%], increased weight [16.8%], and akathisia [10.9%]).
CONCLUSIONS


AL and PP were efficacious and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing outpatient treatment.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03345979.",2020,"For AL, the mean baseline PANSST was 94.1; scores were significantly reduced from baseline at week 4 (-17.4; P < .001) and were also reduced at weeks 9 (-19.8) and 25 (-23.3).","['Adults with acute schizophrenia according to DSM-5 criteria', 'Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care', 'November 2017 to March 2019', '200 patients were randomized (AL, n = 99; PP, n = 101); 56.6% and 42.6%, respectively, completed the study']","['Aripiprazole Lauroxil With 1-Day Initiation', 'paliperidone palmitate', 'Aripiprazole Lauroxil and Paliperidone palmitate', 'lauroxil (AL) with 1-day initiation', 'aripiprazole', 'AL (AL NanoCrystal Dispersion + oral aripiprazole']","['Efficacy and Safety', 'increased weight', 'Positive and Negative Syndrome Scale total score (PANSST', 'Adverse events (AEs) and laboratory data', 'akathisia', 'injection site pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0857501', 'cui_str': 'Acute schizophrenia'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4056439', 'cui_str': 'aripiprazole lauroxil'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4056439', 'cui_str': 'aripiprazole lauroxil'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C2719626', 'cui_str': 'Paliperidone palmitate'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C1721058', 'cui_str': 'Nanocrystals'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}]",200.0,0.518152,"For AL, the mean baseline PANSST was 94.1; scores were significantly reduced from baseline at week 4 (-17.4; P < .001) and were also reduced at weeks 9 (-19.8) and 25 (-23.3).","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Weiden', 'Affiliation': 'Karuna Therapeutics, 33 Arch Street, Suite 3110, Boston, MA 02110. pjweiden@gmail.com.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Claxton', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Kunovac', 'Affiliation': 'Altea Research, Las Vegas, Nevada, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Walling', 'Affiliation': 'CNS Network, LLC, Garden Grove, California, USA.'}, {'ForeName': 'Yangchun', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Baiyun', 'Initials': 'B', 'LastName': 'Yao', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Yagoda', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Ilda', 'Initials': 'I', 'LastName': 'Bidollari', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Keane', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Cash', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m13207']
2919,31437695,"Antidepressant and antisuicidal effects of ketamine on the functional connectivity of prefrontal cortex-related circuits in treatment-resistant depression: A double-blind, placebo-controlled, randomized, longitudinal resting fMRI study.","BACKGROUND


Increasing evidence suggests that infusion of a subanesthetic dose of ketamine exerts antidepressant and antisuicidal effects in patients with treatment-resistant depression (TRD).
AIMS


In this investigation, we used the resting functional connectivity magnetic resonance imaging (fcMRI) to determine the effects of ketamine on the functional connectivity (FC) of prefrontal cortex (PFC)-related circuits in patients with TRD.
METHODS


Forty-eight patients with TRD were recruited and randomly divided into three groups on the basis of ketamine infusion dose: 0.5 mg/kg (standard dose), 0.2 mg/kg (low dose), or normal saline (a placebo infusion). Resting functional MRI data and clinical data were recorded at the baseline and on the third day after ketamine infusion treatment.
RESULTS


The standard-dose group showed a reduction in the FC of the left dorsal anterior cingulate cortex (dACC) and right dorsolateral (dl)PFC with the other frontal regions. The low-dose group demonstrated a more pervasive reduction of FC in the bilateral dACC with other frontal and parietal regions. A negative correlation was observed between the reduction in suicidal ideation and the reduction in the FC between the left dACC and right ACC regions in the standard-dose group, whereas a positive correlation was observed between the reduction in suicidal ideation and the increase in the FC between the right dlPFC and left superior parietal region in the low-dose group.
CONCLUSIONS


Our results support the hypothesis that PFC-related circuit modulation is crucial to the antidepressant and antisuicidal effects of the ketamine infusion treatment.",2019,The low-dose group demonstrated a more pervasive reduction of FC in the bilateral dACC with other frontal and parietal regions.,"['treatment-resistant depression', 'Forty-eight patients with TRD', 'patients with treatment-resistant depression (TRD', 'patients with TRD']","['ketamine infusion dose: 0.5\u202fmg/kg (standard dose), 0.2\u202fmg/kg (low dose), or normal saline (a placebo', 'placebo', 'ketamine']","['functional connectivity (FC) of prefrontal cortex (PFC)-related circuits', 'FC of the left dorsal anterior cingulate cortex (dACC) and right dorsolateral (dl)PFC', 'Resting functional MRI data and clinical data', 'suicidal ideation']","[{'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C2983598', 'cui_str': 'Dorsolateral'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}]",48.0,0.0367843,The low-dose group demonstrated a more pervasive reduction of FC in the bilateral dACC with other frontal and parietal regions.,"[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Department of Medical Research, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Philosophy of Mind and Cognition, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan. Electronic address: peichitu@gmail.com.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Brain Science, National Yang-Ming University, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Philosophy of Mind and Cognition, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan; Division of Psychiatry, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Psychiatry, General Cheng Hsin Hospital, Taipei, Taiwan. Electronic address: tomsu0402@gmail.com.'}]",Journal of affective disorders,['10.1016/j.jad.2019.08.022']
2920,31256116,"The Effectiveness of a Web-Based Health Education Tool, WESIHAT 2.0, among Older Adults: A Randomized Controlled Trial.","BACKGROUND


Intervention strategies, especially online based approaches, are considered to be beneficial in improving the health of the senior. The effectiveness of such approaches is yet to be determined.
OBJECTIVE


This study aims to determine the effectiveness of the web-based application, WESIHAT 2.0©, for improving cognitive function, physical fitness, biochemical indices, and psychosocial variables among older adults in Klang Valley, Malaysia. The cost analysis of WESIHAT 2.0© was also determined.
METHOD


The study utilized a two-arm randomized controlled trial with 25 subjects in each of the intervention and control groups. The participants chosen for the study included those who were 60 years and above with at least secondary education and had internet access using a computer at home. The intervention group was exposed to the website (30 minutes per day, 4 days per week) for six months, while the control group was given health education pamphlets. Activity-Based Costing method was used to determine the cost saved using WESIHAT 2.0© as compared to using the pamphlet.
RESULTS


Significant intervention effects were observed for self-perception of disability and informational support scores. WESIHAT 2.0© was able to save costs in improving the self-perception of disability score and the informational support score at MYR 6.92 and MYR 13.52, respectively, compared to the conventional method.
CONCLUSION


WESIHAT 2.0© was able to save costs in improving the self-perceived disability and informational support scores for the intervention group.",2019,WESIHAT 2.0© was able to save costs in improving the self-perceived disability and informational support scores for the intervention group.,"['25 subjects in each of the intervention and control groups', 'older adults in Klang Valley, Malaysia', 'Older Adults', 'participants chosen for the study included those who were 60 years and above with at least secondary education and had internet access using a computer at home']",['control group was given health education pamphlets'],"['self-perception of disability score and the informational support score', 'cognitive function, physical fitness, biochemical indices, and psychosocial variables', 'self-perception of disability and informational support scores', 'self-perceived disability and informational support scores']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0563004', 'cui_str': 'Valley (environment)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0018701'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",,0.0503029,WESIHAT 2.0© was able to save costs in improving the self-perceived disability and informational support scores for the intervention group.,"[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Vanoh', 'Affiliation': 'Nutrition and Dietetics Programme, School of Health Sciences, Universiti Sains Malaysia, Health Campus, Kubang Kerian, Kelantan.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Shahar', 'Affiliation': 'Centre for Healthy Ageing and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Rosdinom', 'Initials': 'R', 'LastName': 'Razali', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latif, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nazlena Mohamad', 'Initials': 'NM', 'LastName': 'Ali', 'Affiliation': 'Institute of Visual Informatics (IVI), Universiti Kebangsaan Malaysia, Bangi Selangor, Malaysia.'}, {'ForeName': 'Zahara Abdul', 'Initials': 'ZA', 'LastName': 'Manaf', 'Affiliation': 'Centre for Healthy Ageing and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Shahrul Azman', 'Initials': 'SA', 'LastName': 'Mohd Noah', 'Affiliation': 'School of Information Technology, Faculty of Information Science and Technology, Universiti Kebangsaan Malaysia, Bangi Selangor, Malaysia.'}, {'ForeName': 'Amrizal Muhammad', 'Initials': 'AM', 'LastName': 'Nur', 'Affiliation': 'International Centre for Casemix and Clinical Coding, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latif, Kuala Lumpur, Malaysia.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-180464']
2921,31408791,Can theta burst stimulation safely influence auditory hearing thresholds in healthy young adults?,"OBJECTIVE


This TBS sham-controlled study aimed to evaluate the effects of intermittent TBS (iTBS) and continuous TBS (cTBS) upon ipsilateral hearing thresholds after stimulation on the left auditory cortex.
METHODS


Sixty healthy adults, aged between 19 and 32 years (median of 23 years), were randomly distributed into three groups and underwent iTBS, cTBS or sham stimulation. Each double-blind experimental session comprised two pure tone audiometric evaluations per subject, before and after stimulation. To assess volunteer safety, a follow-up of at least 48 hours was implemented.
RESULTS


The iTBS group mean thresholds displayed a tendency to decrease after stimulation, predominantly in the 500 Hz-6000 Hz interval and group comparisons revealed significant differences between the iTBS and sham groups for 500 Hz (p = 0.041) and between the iTBS and cTBS groups for 4000 Hz (p = 0.038). Neither relevant side effects nor any significant hearing threshold impairment after active or sham stimulation were found.
CONCLUSIONS


A single stimulation session led to an effective neuromodulation of the auditory cortex, reflected in lower thresholds when using iTBS.
SIGNIFICANCE


These encouraging results with this safe noninvasive tool suggest that iTBS may have the potential to positively influence hearing thresholds.",2019,"The iTBS group mean thresholds displayed a tendency to decrease after stimulation, predominantly in the 500 Hz-6000 Hz interval and group comparisons revealed significant differences between the iTBS and sham groups for 500 Hz (p = 0.041) and between the iTBS and cTBS groups for 4000 Hz (p = 0.038).","['healthy young adults', 'Sixty healthy adults, aged between 19 and 32\u202fyears (median of 23\u202fyears']","['iTBS, cTBS or sham stimulation', 'intermittent TBS (iTBS) and continuous TBS (cTBS']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]",[],60.0,0.0896543,"The iTBS group mean thresholds displayed a tendency to decrease after stimulation, predominantly in the 500 Hz-6000 Hz interval and group comparisons revealed significant differences between the iTBS and sham groups for 500 Hz (p = 0.041) and between the iTBS and cTBS groups for 4000 Hz (p = 0.038).","[{'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Pinto', 'Affiliation': 'CICS-Health Sciences Research Centre, University of Beira Interior, Covilhã 6200-506, Portugal; Dr. Lopes Dias School of Health - Polytechnic Institute of Castelo Branco, 6000-767, Portugal. Electronic address: nfcpinto@gmail.com.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Oliveira', 'Affiliation': 'CICS-Health Sciences Research Centre, University of Beira Interior, Covilhã 6200-506, Portugal. Electronic address: a30345@fcsaude.ubi.pt.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Ferreira', 'Affiliation': 'CICS-Health Sciences Research Centre, University of Beira Interior, Covilhã 6200-506, Portugal. Electronic address: a21912@fcsaude.ubi.pt.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gama', 'Affiliation': 'CICS-Health Sciences Research Centre, University of Beira Interior, Covilhã 6200-506, Portugal; University of Beira Interior - Department of Mathematics, Covilhã 6200-506, Portugal. Electronic address: jgama@ubi.pt.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vaz Pato', 'Affiliation': 'CICS-Health Sciences Research Centre, University of Beira Interior, Covilhã 6200-506, Portugal; Sousa Martins Hospital, Guarda Local Health Unit, Guarda 6300-858, Portugal. Electronic address: mariavazpato@gmail.com.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2019.07.019']
2922,31477140,Implementation of the uterine fibroids Option Grid patient decision aids across five organizational settings: a randomized stepped-wedge study protocol.,"BACKGROUND


Uterine fibroids are non-cancerous overgrowths of the smooth muscle in the uterus. As they grow, some cause problems such as heavy menstrual bleeding, pelvic pain, discomfort during sexual intercourse, and rarely pregnancy complications or difficulty becoming pregnant. Multiple treatment options are available. The lack of comparative evidence demonstrating superiority of any one treatment means that choosing the best option is sensitive to individual preferences. Women with fibroids wish to consider treatment trade-offs. Tools known as patient decision aids (PDAs) are effective in increasing patient engagement in the decision-making process. However, the implementation of PDAs in routine care remains challenging. Our aim is to use a multi-component implementation strategy to implement the uterine fibroids Option Grid™ PDAs at five organizational settings in the USA.
METHODS


We will conduct a randomized stepped-wedge implementation study where five sites will be randomized to implement the uterine fibroid Option Grid PDA in practice at different time points. Implementation will be guided by the Consolidated Framework for Implementation Research (CFIR) and Normalization Process Theory (NPT). There will be a 6-month pre-implementation phase, a 2-month initiation phase where participating clinicians will receive training and be introduced to the Option Grid PDAs (available in text, picture, or online formats), and a 6-month active implementation phase where clinicians will be expected to use the PDAs with patients who are assigned female sex at birth, are at least 18 years of age, speak fluent English or Spanish, and have new or recurrent symptoms of uterine fibroids. We will exclude postmenopausal patients. Our primary outcome measure is the number of eligible patients who receive the Option Grid PDAs. We will use logistic and linear regression analyses to compare binary and continuous quantitative outcome measures (including survey scores and Option Grid use) between the pre- and active implementation phases while adjusting for patient and clinician characteristics.
DISCUSSION


This study may help identify the factors that impact the implementation and sustained use of a PDA in clinic workflow from various stakeholder perspectives while helping patients with uterine fibroids make treatment decisions that align with their preferences.
TRIAL REGISTRATION


Clinicaltrials.gov , NCT03985449. Registered 13 July 2019, https://clinicaltrials.gov/ct2/show/NCT03985449.",2019,"This study may help identify the factors that impact the implementation and sustained use of a PDA in clinic workflow from various stakeholder perspectives while helping patients with uterine fibroids make treatment decisions that align with their preferences.
","['Women with fibroids', 'patients who are assigned female sex at birth, are at least 18\u2009years of age, speak fluent English or Spanish, and have new or recurrent symptoms of uterine fibroids', 'postmenopausal patients', 'patients with uterine fibroids']",[],['number of eligible patients who receive the Option Grid PDAs'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.102921,"This study may help identify the factors that impact the implementation and sustained use of a PDA in clinic workflow from various stakeholder perspectives while helping patients with uterine fibroids make treatment decisions that align with their preferences.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Scalia', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, One Medical Center Drive, 5th floor, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Durand', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, One Medical Center Drive, 5th floor, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Forcino', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, One Medical Center Drive, 5th floor, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Schubbe', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, One Medical Center Drive, 5th floor, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Barr', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, One Medical Center Drive, 5th floor, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': ""O'Brien"", 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, One Medical Center Drive, 5th floor, Lebanon, NH, 03756, USA.'}, {'ForeName': 'A James', 'Initials': 'AJ', 'LastName': ""O'Malley"", 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, One Medical Center Drive, 5th floor, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Foster', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, One Medical Center Drive, 5th floor, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Politi', 'Affiliation': 'Department of Surgery, Division of Public Health Sciences, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Laughlin-Tommaso', 'Affiliation': 'Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Banks', 'Affiliation': ""Department of Obstetrics and Gynecology and Women's Health, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, USA.""}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Madden', 'Affiliation': 'Department of Surgery, Division of Public Health Sciences, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Raymond M', 'Initials': 'RM', 'LastName': 'Anchan', 'Affiliation': ""Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology & Reproductive Biology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Johanna W M', 'Initials': 'JWM', 'LastName': 'Aarts', 'Affiliation': 'Department of Obstetrics and Gynecology, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Velentgas', 'Affiliation': 'Aetion, Boston, MA, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Balls-Berry', 'Affiliation': 'College of Medicine and Science, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Bacon', 'Affiliation': 'National Uterine Fibroids Foundation, Colorado Springs, CO, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Adams-Foster', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, One Medical Center Drive, 5th floor, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Carrie Cahill', 'Initials': 'CC', 'LastName': 'Mulligan', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, One Medical Center Drive, 5th floor, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Sateria', 'Initials': 'S', 'LastName': 'Venable', 'Affiliation': 'The Fibroid Foundation, Bethesda, MD, USA.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Cochran', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, One Medical Center Drive, 5th floor, Lebanon, NH, 03756, USA.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Elwyn', 'Affiliation': 'The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, One Medical Center Drive, 5th floor, Lebanon, NH, 03756, USA. glynelwyn@gmail.com.'}]",Implementation science : IS,['10.1186/s13012-019-0933-z']
2923,32434001,Platelet activation and placenta-mediated adverse pregnancy outcomes: an ancillary study to the EAGeR trial.,"BACKGROUND


Platelet activation may play a role in the pathophysiology of placenta-mediated obstetric complications, as evidenced by the efficacy of aspirin for preventing preeclampsia, but published data regarding the relationship between biomarkers for platelet activation and adverse obstetric outcomes are sparse. Specifically, it is unknown whether pre-pregnancy biomarkers of platelet activation are associated with adverse pregnancy outcomes.
OBJECTIVES


To determine: 1) whether maternal plasma concentrations of platelet factor 4 are associated with risk of placenta-mediated adverse obstetric outcomes, and 2) whether these associations are modified by low-dose aspirin.
STUDY DESIGN


This ancillary study included measurement of platelet factor 4 among 1,185 of the 1,228 reproductive-age women enrolled in the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial with available plasma samples, with relevant outcomes assessed among 584 women with pregnancies lasting at least 20 weeks' gestation. We measured platelet factor 4 in plasma samples obtained at the pre-pregnancy study visit (prior to randomization to low-dose aspirin or placebo), 12 weeks of gestation, and 28 weeks of gestation. The primary outcome was a composite of hypertensive disorders of pregnancy, placental abruption, and small-for-gestational age neonate. We estimated relative risks and 95% confidence intervals for the association between platelet factor 4 and the composite and individual outcomes at each time point using log-binomial regression that was weighted to account for potential selection bias and adjusted for age, BMI, education, income, and smoking. To evaluate potential effect modification by aspirin, we stratified analyses by aspirin treatment assignment.
RESULTS


During follow-up, 95 women experienced the composite adverse obstetric outcome, with 57 cases of hypertensive disorders of pregnancy, 35 of small-for-gestational age (SGA), and 6 of placental abruption. Overall, pre-pregnancy platelet factor 4 was positively associated with the composite outcome (tertile 3 vs. tertile 1 RR 2.36, 95% CI 1.38, 4.03) and with hypertensive disorders of pregnancy (tertile 3 vs. tertile 1 RR 2.14, 95% CI 1.08, 4.23). In analyses stratified by treatment group, associations were stronger in the placebo (tertile 3 vs. tertile 1 RR 3.36, 95% CI 1.42, 7.93) versus the aspirin group (tertile 3 vs. tertile 1 RR 1.78, 95% CI 0.90, 3.50).
CONCLUSIONS


High concentrations of platelet factor 4 prior to pregnancy are associated with increased risk of placenta-mediated adverse pregnancy outcomes, particularly for hypertensive disorders of pregnancy. Aspirin may mitigate the increased risk of these outcomes among women with higher plasma concentrations of preconception platelet factor 4, but low-dose aspirin non-responders may require higher doses of aspirin or alternate therapies to achieve obstetric risk reduction.",2020,"In analyses stratified by treatment group, associations were stronger in the placebo (tertile 3 vs. tertile 1 RR 3.36, 95% CI 1.42, 7.93) versus the aspirin group (tertile 3 vs. tertile 1 RR 1.78, 95% CI 0.90, 3.50).
","[""1,185 of the 1,228 reproductive-age women enrolled in the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial with available plasma samples, with relevant outcomes assessed among 584 women with pregnancies lasting at least 20 weeks' gestation"", '95 women experienced the composite adverse obstetric outcome, with 57 cases of hypertensive disorders of pregnancy, 35 of small-for-gestational age (SGA), and 6 of placental abruption']","['Aspirin', 'aspirin', 'aspirin or placebo']","['composite of hypertensive disorders of pregnancy, placental abruption, and small-for-gestational age neonate', 'hypertensive disorders of pregnancy', 'Platelet activation and placenta-mediated adverse pregnancy outcomes']","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",584.0,0.178718,"In analyses stratified by treatment group, associations were stronger in the placebo (tertile 3 vs. tertile 1 RR 3.36, 95% CI 1.42, 7.93) versus the aspirin group (tertile 3 vs. tertile 1 RR 1.78, 95% CI 0.90, 3.50).
","[{'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Theilen', 'Affiliation': 'University of Utah Health, Department of Obstetrics & Gynecology, Salt Lake City, UT; Intermountain Healthcare, Women & Newborns Clinical Program, Salt Lake City, UT. Electronic address: lauren.theilen@hsc.utah.edu.'}, {'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Campbell', 'Affiliation': 'University of Utah Health, Department of Obstetrics & Gynecology, Salt Lake City, UT; Intermountain Healthcare, Women & Newborns Clinical Program, Salt Lake City, UT.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Epidemiology Branch, Division of Intramural Population Health Research, Bethesda, MD.'}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Purdue-Smithe', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Epidemiology Branch, Division of Intramural Population Health Research, Bethesda, MD.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Epidemiology Branch, Division of Intramural Population Health Research, Bethesda, MD.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Epidemiology Branch, Division of Intramural Population Health Research, Bethesda, MD.'}, {'ForeName': 'Jeannie G', 'Initials': 'JG', 'LastName': 'Radoc', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Epidemiology Branch, Division of Intramural Population Health Research, Bethesda, MD.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'University of Utah Health, Department of Obstetrics & Gynecology, Salt Lake City, UT; Intermountain Healthcare, Women & Newborns Clinical Program, Salt Lake City, UT.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Epidemiology Branch, Division of Intramural Population Health Research, Bethesda, MD.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.026']
2924,32433915,Impact of Fellow Participation on Colon Adenoma Detection Rates: A Multicenter Randomized Trial.,"BACKGROUND AND AIMS


There are limited and conflicting data on the impact of fellow participation in improving colon adenoma detection rate. We performed a multicenter randomized-controlled trial to evaluate whether the fellow involvement might exert a beneficial effect on adenoma detection rate.
METHODS


The trial was conducted at four tertiary hospitals between April and December 2019. Eight hundred twelve patients were randomized to undergo colonoscopy performed by a fellow under staff endoscopist's supervision or by an attending physician alone.
RESULTS


No significant differences in demographic or adenoma risk factors were detected between the 2 groups. The adenoma detection rate in the intervention group was 44.8% versus 37.1% in the control arm (p=0.02). Mean number of adenomas per colonoscopy was significantly higher in the intervention group (0.65±0.3 versus 0.53±0.2 in the control arm, p<0.001). Polyp detection rate was 69.7% in the intervention group as compared to 62.5% in the control arm (p=0.03), whereas rates of advanced and sessile/serrated adenoma were not different between the trial arms (p=0.50 and 0.42, respectively). In the subgroup of more experienced fellows, ADR and PDR were 49.5% and 75.7%, respectively. No difference was observed between less-experienced fellows and attending physicians alone (p=0.53 and 0.86, respectively). Level of bowel preparation and fellow involvement were significant predictors of increased adenoma detection rate in multivariate analysis.
CONCLUSIONS


Our multicenter trial represents the first prospective validation of the beneficial role of fellow involvement in colonoscopy procedures. ClinicalTrials.gov no: NCT03908229.",2020,"Polyp detection rate was 69.7% in the intervention group as compared to 62.5% in the control arm (p=0.03), whereas rates of advanced and sessile/serrated adenoma were not different between the trial arms (p=0.50 and 0.42, respectively).","['four tertiary hospitals between April and December 2019', 'Eight hundred twelve patients']","['Fellow Participation', ""colonoscopy performed by a fellow under staff endoscopist's supervision or by an attending physician alone""]","['demographic or adenoma risk factors', 'rates of advanced and sessile/serrated adenoma', 'Colon Adenoma Detection Rates', 'adenoma detection rate', 'Mean number of adenomas per colonoscopy', 'ADR and PDR', 'Polyp detection rate']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C1320929', 'cui_str': 'Attending physician'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205348', 'cui_str': 'Sessile'}, {'cui': 'C1266025', 'cui_str': 'Traditional serrated adenoma'}, {'cui': 'C4551463', 'cui_str': 'Colon adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C1845050', 'cui_str': 'Pigmentary Disorder, Reticulate, with Systemic Manifestations'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}]",812.0,0.134147,"Polyp detection rate was 69.7% in the intervention group as compared to 62.5% in the control arm (p=0.03), whereas rates of advanced and sessile/serrated adenoma were not different between the trial arms (p=0.50 and 0.42, respectively).","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Facciorusso', 'Affiliation': 'Gastroenterology Unit, Department of Medical Sciences, University of Foggia, Foggia, Italy. Electronic address: antonio.facciorusso@virgilio.it.'}, {'ForeName': 'Vincenzo Rosario', 'Initials': 'VR', 'LastName': 'Buccino', 'Affiliation': 'Gastroenterology Unit, Department of Medical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Tonti', 'Affiliation': 'Gastroenterology Unit, Department of Medical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Licinio', 'Affiliation': 'Endoscopy Unit, Ospedale Santissima Annunziata, Taranto, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Del Prete', 'Affiliation': 'Endoscopy Unit, Ospedale A. Perrino, Brindisi, Italy.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Neve', 'Affiliation': 'Endoscopy Unit, Ospedale A. Perrino, Brindisi, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Di Maso', 'Affiliation': 'Endoscopy Unit, Ospedale Teresa Masselli Mascia, San Severo, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Muscatiello', 'Affiliation': 'Gastroenterology Unit, Department of Medical Sciences, University of Foggia, Foggia, Italy.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.05.015']
2925,31473331,A randomized controlled trial of a smoking cessation self-help intervention for Spanish-speaking Hispanic/Latinx smokers: Study design and baseline characteristics.,"Although the current smoking prevalence among Hispanics/Latinxs (10%) is lower than in non-Hispanic whites (15%), higher prevalence is observed among certain subgroups (e.g., Puerto Rican males, 19%). Hispanic/Latinx smokers face unique challenges such as lower awareness and acceptability of nicotine replacement aids, lower prevalence of using counseling or medication, and receiving less advice to quit by their health care providers. Despite these barriers to smoking cessation, few interventions specifically targeted to Hispanic/Latinx smokers have been developed and evaluated. This paper summarizes the design, methods, analysis plan, and sample baseline characteristics of an ongoing randomized controlled trial to assess the efficacy of a Spanish-language self-help smoking cessation intervention among Hispanics/Latinxs. Current smokers who prefer health education materials in Spanish were randomized to one of two conditions. The usual care group received a standard smoking cessation booklet developed by the National Cancer Institute. The intervention group received 10 booklets, 9 pamphlets and a booklet for family and friends mailed monthly over 18 months. All participants complete self-report surveys every 6 months over 2 years. Smoking abstinence is biochemically verified at 12- and 24-month follow-up. A total of 2387 smokers were screened, 2056 were eligible and 1417 were enrolled in the study. The primary outcome is self-reported 7-day point prevalence abstinence. If the intervention is deemed efficacious, it has potential to have a large public health impact with respect to reducing smoking rates and smoking related morbidity and mortality among a large underserved minority population.",2019,"If the intervention is deemed efficacious, it has potential to have a large public health impact with respect to reducing smoking rates and smoking related morbidity and mortality among a large underserved minority population.","['A total of 2387 smokers were screened, 2056 were eligible and 1417 were enrolled in the study', 'Hispanic/Latinx smokers', 'Current smokers who prefer health education materials in Spanish', 'Spanish-speaking Hispanic/Latinx smokers', 'Hispanics/Latinxs']","['smoking cessation self-help intervention', 'Spanish-language self-help smoking cessation intervention', 'standard smoking cessation booklet', '10 booklets, 9 pamphlets and a booklet for family and friends mailed monthly over 18\u202fmonths']","['self-reported 7-day point prevalence abstinence', 'Smoking abstinence']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C3241966'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C0018701'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037750', 'cui_str': 'Spanish language (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",2056.0,0.0207541,"If the intervention is deemed efficacious, it has potential to have a large public health impact with respect to reducing smoking rates and smoking related morbidity and mortality among a large underserved minority population.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Medina-Ramírez', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA.'}, {'ForeName': 'Úrsula', 'Initials': 'Ú', 'LastName': 'Martínez', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Cathy D', 'Initials': 'CD', 'LastName': 'Meade', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Byrne', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA.'}, {'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Brandon', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Meltzer', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Fiorella M', 'Initials': 'FM', 'LastName': 'Gonzales', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA.'}, {'ForeName': 'Vani N', 'Initials': 'VN', 'LastName': 'Simmons', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA. Electronic address: Vani.Simmons@Moffitt.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105836']
2926,31473598,"Lack of effects of evidence-based, individualised counselling on medication use in insured patients with mild hypertension in China: a randomised controlled trial.","OBJECTIVE


To evaluate whether evidence-based, individualised (EBI) counselling regarding hypertension and the treatment would affect medication use in insured patients with mild hypertension in China.
METHODS


We conducted a parallel-group, randomised controlled trial in two primary care centres in Shenzhen, a metropolitan city in China. Patients with mild primary hypertension, 10-year risk of cardiovascular diseases (CVDs) lower than 20% and no history of CVDs were recruited and randomly allocated to two groups. EBI plus general counselling was provided to the intervention group and general counselling alone to the control group. EBI counselling included information on the 10-year CVD risk and treatment benefit in terms of absolute risk reduction estimated for each individual and information on average side effects and costs of antihypertensive drugs. The outcomes included use of antihypertensive drugs and adherence to the treatment at 6-month follow-up, with the former being primary outcome.
RESULTS


Two hundred and ten patients were recruited, with 103 and 107 allocated to the intervention and control groups, respectively. At baseline, 62.4% of the patients were taking antihypertensive drugs that were all covered by health insurance. At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36). The difference in adherence rate between the two groups was not statistically significant either (43.7% vs 40.2%; OR=1.15, 95% CI 0.67 to 2.00]). The results were robust in sensitivity analyses that used different cutoffs to define the two outcomes.
CONCLUSIONS


The EBI counselling by health educators other than the caring physicians had little impact on treatment choices and drug-taking behaviours in insured patients with mild primary hypertension in this study. It remains unclear whether EBI counselling would make a difference in uninsured patients, especially when conducted by the caring physicians.
TRIAL REGISTRATION NUMBER


ChiCTR-TRC-14004169.",2020,"At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36).","['insured patients with mild primary hypertension', 'two primary care centres in Shenzhen, a metropolitan city in China', 'insured patients with mild hypertension in China', 'Two hundred and ten patients were recruited, with 103 and 107 allocated to the intervention and control groups, respectively', 'Patients with mild primary hypertension, 10-year risk of cardiovascular diseases (CVDs) lower than 20% and no history of CVDs']","['individualised (EBI) counselling', 'individualised counselling']","['adherence rate', 'rate of medication use', '10-year CVD risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",210.0,0.163999,"At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36).","[{'ForeName': 'Mengyang', 'Initials': 'M', 'LastName': 'Di', 'Affiliation': 'Department of Medicine, Rhode Island Hospital, Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': 'Department of Epidemiology, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zuyao', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Division of Epidemiology, School of Public Health and Primary Care, Chinese University of Hong Kong, New Territories, Hong Kong.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Longgang Center for Disease Control and Prevention, Shenzhen, China.'}, {'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Longgang Center for Disease Control and Prevention, Shenzhen, China.'}, {'ForeName': 'Shuiming', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Longgang Center for Disease Control and Prevention, Shenzhen, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': ""Central City Community Healthcare Centre, Longgang People's Hospital, Shenzhen, China.""}, {'ForeName': 'Kunhua', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': ""Ziwei Garden Community Healthcare Centre, Longgang People's Hospital, Shenzhen, China.""}, {'ForeName': 'Jinling', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Division of Epidemiology, School of Public Health and Primary Care, Chinese University of Hong Kong, New Territories, Hong Kong jltang@cuhk.edu.hk.'}]",BMJ evidence-based medicine,['10.1136/bmjebm-2019-111197']
2927,31431411,Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults ≥65 years of age: A phase 3 randomized clinical trial.,"BACKGROUND


A high-dose, split-virion inactivated trivalent influenza vaccine (IIV3-HD; Fluzone® High-Dose, Sanofi Pasteur) is available for adults ≥65 years of age. This study examined the safety and immunogenicity of a quadrivalent high-dose split-virion inactivated influenza vaccine (IIV4-HD).
METHODS


This was a randomized, modified double-blind, active-controlled, multi-center trial in healthy adults ≥65 years of age. Subjects were randomized in a 4:1:1 ratio to receive a single intramuscular injection of IIV4-HD, the licensed IIV3-HD, or an IIV3-HD containing the alternate B-lineage strain. Hemagglutination inhibition (HAI), seroneutralisation, and anti-neuraminidase antibody titers were measured at baseline and day 28. Solicited reactions were collected for up to 7 days, unsolicited adverse events up to 28 days, and serious adverse events up to 180 days. The primary immunogenicity objective was to demonstrate that IIV4-HD induces HAI geometric mean titers (GMTs) and seroconversion rates that are non-inferior to those induced by IIV3-HD. Secondary objectives were to describe the safety of IIV4-HD and IIV3-HD and to demonstrate that IIV4-HD induces HAI GMTs and seroconversion rates that are superior to those induced by IIV3-HD not containing the same B-lineage strain.
RESULTS


The study included 2670 adults ≥65 years of age. For all four strains, HAI GMTs and seroconversion rates induced by IIV4-HD were non-inferior to those induced by IIV3-HDs containing the same strains. For both B strains, HAI GMTs and seroconversion rates induced by IIV4-HD were superior to those induced by IIV3-HD not containing the same B-lineage strain. Seroneutralisation and anti-neuraminidase antibody responses, measured in a subset of subjects, were similar. No new safety concerns were identified, and the safety profiles of IIV4-HD and IIV3-HD were similar.
CONCLUSIONS


Adding a second B strain in IIV4-HD resulted in improved immunogenicity against the added strain without compromising the immunogenicity of the other strains or the vaccine's tolerability.
CLINICAL TRIAL REGISTRATION


NCT03282240.",2019,"For both B strains, HAI GMTs and seroconversion rates induced by IIV4-HD were superior to those induced by IIV3-HD not containing the same B-lineage strain.","['2670 adults ≥65\u202fyears of age', 'healthy adults ≥65\u202fyears of age', 'adults ≥65\u202fyears of age']","['split-virion inactivated trivalent influenza vaccine (IIV3-HD; Fluzone® High-Dose, Sanofi Pasteur', 'high-dose quadrivalent influenza vaccine', 'quadrivalent high-dose split-virion inactivated influenza vaccine (IIV4-HD', 'single intramuscular injection of IIV4-HD, the licensed IIV3-HD, or an IIV3-HD containing the alternate B-lineage strain']","['Safety and immunogenicity', 'safety of IIV4-HD and IIV3-HD and to demonstrate that IIV4-HD induces HAI GMTs and seroconversion rates', 'serious adverse events', 'Hemagglutination inhibition (HAI), seroneutralisation, and anti-neuraminidase antibody titers', 'IIV4-HD induces HAI geometric mean titers (GMTs) and seroconversion rates', 'unsolicited adverse events', 'safety and immunogenicity', 'safety profiles of IIV4-HD and IIV3-HD', 'HAI GMTs and seroconversion rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C0770694'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0027803', 'cui_str': 'N-Acylneuraminate Glycohydrolases'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",2670.0,0.124097,"For both B strains, HAI GMTs and seroconversion rates induced by IIV4-HD were superior to those induced by IIV3-HD not containing the same B-lineage strain.","[{'ForeName': 'Lee-Jah', 'Initials': 'LJ', 'LastName': 'Chang', 'Affiliation': 'Sanofi Pasteur, 1 Discovery Dr, Swiftwater, PA 18370, USA. Electronic address: Lee-Jah.Chang@sanofi.com.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'Sanofi Pasteur, 1 Discovery Dr, Swiftwater, PA 18370, USA.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Janosczyk', 'Affiliation': 'Sanofi Pasteur, 1 Discovery Dr, Swiftwater, PA 18370, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Landolfi', 'Affiliation': 'Sanofi Pasteur, 1 Discovery Dr, Swiftwater, PA 18370, USA.'}, {'ForeName': 'H Keipp', 'Initials': 'HK', 'LastName': 'Talbot', 'Affiliation': 'Vanderbilt University Medical Center, 1161 21st Avenue South, Nashville, TN 37232, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2019.08.016']
2928,31431412,"Immunogenicity and safety of a 2-dose hepatitis B vaccine, HBsAg/CpG 1018, in persons with diabetes mellitus aged 60-70 years.","BACKGROUND


Hepatitis B virus (HBV) remains a major public health issue, although it is a vaccine-preventable disease. Adults with diabetes are at greater risk of contracting HBV than the general population. Commonly used 3-dose HBV vaccines have reduced immunogenicity in older individuals and in those with diabetes mellitus.
METHODS


In this post hoc analysis of a phase 3 clinical trial, participants with type 2 diabetes mellitus aged 60-70 years received either 2-dose HBsAg/CpG 1018 (HEPLISAV-B®, n = 327) at 0 and 4 weeks and placebo at 24 weeks or 3-dose HBsAg/alum (Engerix-B®, n = 153) at 0, 4, and 24 weeks. Immunogenicity, including seroprotection rate (SPR) at week 28, and safety were assessed by subgroup (sex, body mass index, and smoking status). SPR was defined as antibody against hepatitis B surface antigen serum concentration ≥10 mIU/mL.
RESULTS


The SPR at week 28 was significantly higher with HBsAg/CpG 1018 (85.8% [235/274]) than with HBsAg/alum (58.5% [76/130]) in the per-protocol analysis, for an overall difference of 27.3% (95% CI, 18.0-36.8). SPRs with HBsAg/CpG 1018 were consistently markedly higher compared with HBsAg/alum, regardless of sex, body mass index, or smoking status. Adverse events and deaths were comparable between groups.
CONCLUSIONS


Two-dose HBsAg/CpG 1018 provides a higher level of seroprotection against HBV than does a 3-dose vaccine (HBsAg/alum) with a similar safety profile in patients aged 60-70 years with type 2 diabetes mellitus. Study identifier: NCT02117934.",2019,"SPRs with HBsAg/CpG 1018 were consistently markedly higher compared with HBsAg/alum, regardless of sex, body mass index, or smoking status.","['participants with type 2 diabetes mellitus aged 60-70\u202fyears received either', 'persons with diabetes mellitus aged 60-70\u202fyears', 'patients aged 60-70\u202fyears with type 2 diabetes mellitus', 'Adults with diabetes']","['2-dose hepatitis B vaccine, HBsAg/CpG', '2-dose HBsAg/CpG 1018 (HEPLISAV-B®, n\u202f=\u202f327) at 0 and 4\u202fweeks and placebo', 'HBV vaccines']","['SPR', 'Immunogenicity and safety', 'Immunogenicity, including seroprotection rate (SPR', 'level of seroprotection against HBV', 'Adverse events and deaths']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C4541385', 'cui_str': 'Heplisav-B'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1018.0,0.154594,"SPRs with HBsAg/CpG 1018 were consistently markedly higher compared with HBsAg/alum, regardless of sex, body mass index, or smoking status.","[{'ForeName': 'Randall N', 'Initials': 'RN', 'LastName': 'Hyer', 'Affiliation': 'Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA 94710, United States. Electronic address: rhyer@dynavax.com.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Janssen', 'Affiliation': 'Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA 94710, United States. Electronic address: rjanssen@dynavax.com.'}]",Vaccine,['10.1016/j.vaccine.2019.08.005']
2929,31443993,"The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged ≥50 years: A randomized trial.","BACKGROUND


This study evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) and the reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine (Tdap) when co-administered in adults aged ≥50 years.
METHODS


In this open label, multi-center study (NCT02052596), participants were randomized 1:1 to the Co-Administration group (RZV dose 1 and Tdap at Day 0 [D0], RZV dose 2 at Month 2 [M2]) or Control group (Tdap at D0, RZV dose 1 at M2, RZV dose 2 at M4). Co-primary objectives were evaluation of the vaccine response rate (VRR) to RZV in the Co-Administration group, and demonstration of non-inferiority of the humoral responses to RZV and Tdap in the Co-Administration compared to Control group. Reactogenicity and safety of RZV and Tdap were also assessed.
RESULTS


VRR to RZV was 97.8% in the Co-Administration group. The non-inferiority criterion was met for the humoral response to RZV and for 4 Tdap antigens, but was not met for the Tdap antigen pertactin. Occurrences of solicited, unsolicited and serious adverse events, and potential immune-mediated diseases were similar between groups.
CONCLUSIONS


Co-administration of RZV and Tdap did not interfere with the humoral immune response to RZV or 4 of the 5 Tdap antigens. No safety concerns were identified.",2019,"Occurrences of solicited, unsolicited and serious adverse events, and potential immune-mediated diseases were similar between groups.
","['adults aged ≥50\u202fyears', 'adults', 'aged ≥50 years']","['adjuvanted recombinant zoster vaccine (RZV) and the reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine (Tdap', 'Co-Administration group (RZV dose 1 and Tdap at Day 0', 'recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine']","['Reactogenicity and safety of RZV and Tdap', 'humoral immune response', 'vaccine response rate (VRR', 'Occurrences of solicited, unsolicited and serious adverse events, and potential immune-mediated diseases']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0535644', 'cui_str': 'DTaP Vaccines'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0031237', 'cui_str': 'Pertussis Vaccine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1155229'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0603903,"Occurrences of solicited, unsolicited and serious adverse events, and potential immune-mediated diseases were similar between groups.
","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Strezova', 'Affiliation': 'GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: ana.x.strezova@gsk.com.'}, {'ForeName': 'Himal', 'Initials': 'H', 'LastName': 'Lal', 'Affiliation': 'GSK, 2301 Renaissance Blvd, King of Prussia, PA 19406-2772, USA. Electronic address: himallal@pfizer.com.'}, {'ForeName': 'Igwebuike', 'Initials': 'I', 'LastName': 'Enweonye', 'Affiliation': 'GSK, 81-87 Hullenberweg, Amsterdam 1101 CL, Netherlands. Electronic address: igwebuike.x.enweonye@gsk.com.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Campora', 'Affiliation': 'GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: laura.e.campora@gsk.com.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Beukelaers', 'Affiliation': 'GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: pierre.x.beukelaers@gsk.com.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Segall', 'Affiliation': 'Clinical Research Atlanta, 175 Country Club Dr. Ste A, Stockbridge 30281, GA, USA. Electronic address: nsegall@clinicalresearchatlanta.com.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Heineman', 'Affiliation': 'GSK, 2301 Renaissance Blvd, King of Prussia, PA 19406-2772, USA. Electronic address: tch3768@gmail.com.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Schuind', 'Affiliation': 'GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA. Electronic address: Anne.E.Schuind@gsk.com.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: cornelia.oostvogels@orange.fr.'}]",Vaccine,['10.1016/j.vaccine.2019.08.001']
2930,31473079,Economic costs of implementing group interventions to reduce diabetes distress in adults with type 1 diabetes mellitus in the T1-REDEEM trial.,"AIMS


This study evaluated the implementation costs of two group interventions, one focused on diabetes education (KnowIt) and one focused directly on diabetes distress (OnTrack), that reduced diabetes distress and HbA1C in adults with poorly controlled type 1 diabetes (T1DM) in the T1-REDEEM trial.
METHODS


Resources used to provide interventions were enumerated using activity-based micro-costing methods. Costs were assigned to resources in 2017 US dollars. US median wage and benefit rates were used to calculate costs of staff time. Cost per unit change was calculated for diabetes distress and HbA1C.
RESULTS


For both interventions, per participant implementation costs were approximately $250 and cost per 1.0 percentage point (11 mmol/mol) change in HbA1C was $1400. Cost per unit change in diabetes distress was $364 for KnowIt and $335 for OnTrack. No statistically significant differences in costs were observed.
CONCLUSIONS


This is the first study to examine the costs of implementing interventions targeting diabetes distress in the context of T1DM. Both interventions had per participant implementation costs in the lower end of the range of previously examined diabetes self-management interventions ($219 to $5390). These inventions and their costs merit further attention because reducing diabetes distress may impact long term T1DM outcomes.
CLINICAL TRIALS REGISTRATION


ClinicalTrials.govNCT02175732.",2019,"No statistically significant differences in costs were observed.
","['adults with type 1 diabetes mellitus', 'adults with poorly controlled type 1 diabetes (T1DM) in the T1-REDEEM trial']",['diabetes education (KnowIt) and one focused directly on diabetes distress (OnTrack'],"['participant implementation costs', 'diabetes distress', 'Cost per unit change in diabetes distress', 'costs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0552523,"No statistically significant differences in costs were observed.
","[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Shumway', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, Box 0884, San Francisco, CA 94143-0884, USA. Electronic address: martha.shumway@ucsf.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fisher', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco, Box 0900, San Francisco, CA 94143-0900, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hessler', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco, Box 0900, San Francisco, CA 94143-0900, USA.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Bowyer', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco, Box 0900, San Francisco, CA 94143-0900, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Polonsky', 'Affiliation': 'Behavioral Diabetes Institute, 5405 Oberlin Drive #100, San Diego, CA 92121, USA.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Masharani', 'Affiliation': 'Department of Medicine, University of California, San Francisco, Box 1222, San Francisco, CA 94143-1222, USA.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.107416']
2931,32433914,Randomized trial comparing the fork-tip and the side-fenestrated needles for EUS-guided fine-needle biopsy of solid pancreatic lesions.,"BACKGROUND AND AIMS


The aim of this study was to compare the performance of EUS-guided fine-needle biopsy using fork-tip (SharkCore, Medtronic, USA) or side-fenestrated (ProCore, Cook Medical, Limerick, Ireland) needles in patients with solid pancreatic lesions.
METHODS


This is a randomized controlled study conducted in a single academic center, including patients who underwent sampling with the fork-tip or the side-fenestrated 22-gauge or 25-gauge needles. Three passes were performed, which were each independently evaluated by a blinded pathologist and by endosonographers for macroscopic on-site evaluation (MOSE). The primary outcome was histological yield, whereas secondary aims were safety, diagnostic yield, sample quality, number of needle passes required to establish a diagnosis, and reliability of MOSE.
RESULTS


One hundred ninety-two patients were enrolled. Both 22-gauge and 25-gauge fork-tip needles retrieved significantly higher rates of histological samples compared with side-fenestrated (p<0.013). Safety and diagnostic accuracy were comparable in the 2 arms, whereas sample quality (tissue integrity and blood contamination) was significantly better in the fork-tip group (p<0.0001). Median number of diagnostic passes was lower using fork-tip needles (p=0.054). The agreement between MOSE and pathological evaluation was almost perfect in the fork-tip group and fair in the side-fenestrated group.
CONCLUSIONS


Both needles showed equivalent safety and diagnostic accuracy. However, fork-tip needles provided higher rate of extremely good quality histological samples and required fewer needle passes to reach a diagnosis. MOSE is a highly reliable tool when fork-tip needles are used as compared with side-fenestrated needles. ClinicalTrial.gov number NCT03622229.",2020,MOSE is a highly reliable tool when fork-tip needles are used as compared with side-fenestrated needles.,"['patients who underwent sampling with the fork-tip or the', 'One hundred ninety-two patients were enrolled', 'patients with solid pancreatic lesions']","['EUS-guided fine-needle biopsy using fork-tip (SharkCore, Medtronic, USA) or side-fenestrated (ProCore, Cook Medical, Limerick, Ireland) needles', 'fork-tip and the side-fenestrated needles for EUS-guided fine-needle biopsy', 'MOSE', 'side-fenestrated 22-gauge or 25-gauge needles']","['Safety and diagnostic accuracy', 'histological yield', 'MOSE and pathological evaluation', 'safety, diagnostic yield, sample quality, number of needle passes required to establish a diagnosis, and reliability of MOSE', 'equivalent safety and diagnostic accuracy', 'rates of histological samples', 'Median number of diagnostic passes', 'sample quality (tissue integrity and blood contamination']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0546910', 'cui_str': 'Fork'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}, {'cui': 'C0546910', 'cui_str': 'Fork'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0454785', 'cui_str': 'Limerick'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0450404', 'cui_str': '22G'}, {'cui': 'C0456638', 'cui_str': '25G'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",192.0,0.0357894,MOSE is a highly reliable tool when fork-tip needles are used as compared with side-fenestrated needles.,"[{'ForeName': 'Stefano Francesco', 'Initials': 'SF', 'LastName': 'Crinò', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy. Electronic address: stefanocrino@hotmail.com.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Le Grazie', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Erminia', 'Initials': 'E', 'LastName': 'Manfrin', 'Affiliation': 'Unit of Pathology, Department of Diagnostics and Public Health, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Conti Bellocchi', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bernardoni', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Granato', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': 'Unit of Epidemiology and Medical Statistics, Department of Diagnostics and Public Health, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Parisi', 'Affiliation': 'Unit of Pathology, Department of Diagnostics and Public Health, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Di Stefano', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Frulloni', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Larghi', 'Affiliation': 'Digestive Endoscopy Unit, Fondazione Policlinico A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Gabbrielli', 'Affiliation': 'Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.05.016']
2932,30748110,Community-based father education intervention on breastfeeding practice-Results of a quasi-experimental study.,"Although the benefits of breastfeeding are well-documented, little is known about how best to encourage fathers to support breastfeeding. A quasi-experimental study of a community-based intervention was designed to examine whether health education to promote fathers' involvement in supporting women is associated with early initiation and exclusive breastfeeding practices. At baseline, 802 couples of fathers with pregnant wives from 12 to 27 weeks of gestational age were recruited to either the intervention group (n = 390) or a control group (n = 412) consisting of couples seeking care through routine maternal and child health services. Fathers in the intervention area received breastfeeding education and counselling services in health facilities and at home visits during the antenatal, delivery, and post-partum periods. Peer education and social exchange concerning breastfeeding were organized in fathers' clubs. After 1 year of the intervention, mothers in the intervention group were more likely to initiate early breastfeeding 49.2 and 35.8% in the intervention and control group respectively, P < 0.001. At 1, 4, and 6 months after birth, 34.8, 18.7, and 1.9% of the mothers in the intervention group were exclusively breastfeeding their children because of birth, respectively, compared with 5.7, 4.0, and 0.0% of those in the control group (P < 0.001). Those practices were associated with the intervention in bivariate and multivariate logistic and Cox regression analyses. Intervention targeting fathers at antenatal and postnatal periods may positively influence the breastfeeding practices of mothers, and it should be an important component of breastfeeding programs.",2019,"After 1 year of the intervention, mothers in the intervention group were more likely to initiate early breastfeeding 49.2 and 35.8% in the intervention and control group respectively, P < 0.001.","[""fathers' clubs"", '802 couples of fathers with pregnant wives from 12 to 27\xa0weeks of gestational age']","['breastfeeding education and counselling services', 'control group (n\xa0=\xa0412) consisting of couples seeking care through routine maternal and child health services', 'Community-based father education intervention']",['likely to initiate early breastfeeding'],"[{'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0242665', 'cui_str': 'Wife (person)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}]","[{'cui': 'C0418914', 'cui_str': 'Lactation education'}, {'cui': 'C0542296', 'cui_str': 'Counselling service'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008079', 'cui_str': 'Child Health Services'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",802.0,0.0236439,"After 1 year of the intervention, mothers in the intervention group were more likely to initiate early breastfeeding 49.2 and 35.8% in the intervention and control group respectively, P < 0.001.","[{'ForeName': 'Tran Huu', 'Initials': 'TH', 'LastName': 'Bich', 'Affiliation': 'Hanoi University of Public Health, Hanoi, Vietnam.'}, {'ForeName': 'Tran Khanh', 'Initials': 'TK', 'LastName': 'Long', 'Affiliation': 'Hanoi University of Public Health, Hanoi, Vietnam.'}, {'ForeName': 'Dinh Phuong', 'Initials': 'DP', 'LastName': 'Hoa', 'Affiliation': 'Hanoi University of Public Health, Hanoi, Vietnam.'}]",Maternal & child nutrition,['10.1111/mcn.12705']
2933,31489742,The REMEDEE trial: 5-Year results on a novel combined sirolimus-eluting and endothelial progenitor cells capturing stent.,"OBJECTIVES


To evaluate the long-term safety and efficacy of the novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5 years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio-Engineered stEnt) trial.
BACKGROUND


Drug-eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations.
METHODS


A total of 183 patients with de novo lesions in native coronary arteries were randomized 2:1 to Combo (n = 124) or Taxus Liberté (n = 59). Primary endpoint was 9 month angiographic in-stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5-year follow-up.
RESULTS


Compared with Taxus, after 5 years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, p = .89), cardiac death (0.8% vs. 5.1%, p = .07), myocardial infarction (4.1% vs. 3.4%, p = .81), target lesion (9.4% vs. 10.2%, p = .78), and target vessel revascularization (14.4% vs. 11.9%, p = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow-up rate at 5 years was 97.7%.
CONCLUSION


At 5-year follow-up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.",2020,No cases of definite stent thrombosis were reported in the Combo group.,['183 patients with de novo lesions in native coronary arteries'],"['abluMinal sirolimus coated bio-Engineered stEnt', 'novel combined sirolimus-eluting and endothelial progenitor cells capturing stent', 'Taxus Liberté', 'Combo', 'novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL']","['safety and effectiveness', 'rates of MACE', 'occurrence of major adverse events (MACE) through 5-year follow-up', 'cardiac death', 'definite stent thrombosis', '9 month angiographic in-stent late lumen loss', 'myocardial infarction', 'target lesion', 'target vessel revascularization']","[{'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0878517', 'cui_str': 'Engineer'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0330199', 'cui_str': 'Taxus'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",183.0,0.0462759,No cases of definite stent thrombosis were reported in the Combo group.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haude', 'Affiliation': 'Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany.'}, {'ForeName': 'Stephen W L', 'Initials': 'SWL', 'LastName': 'Lee', 'Affiliation': 'Queen Mary Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Worthley', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Sigmund', 'Initials': 'S', 'LastName': 'Silber', 'Affiliation': 'Cardiology Practice and Hospital, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Verheye', 'Affiliation': 'Ziekenhuis Netwerk Antwerpen Middelheim, Antwerp, Belgium.'}, {'ForeName': 'Mohd A', 'Initials': 'MA', 'LastName': 'Rosli', 'Affiliation': 'Institut Jantung Negara, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Botelho', 'Affiliation': 'Instituto de Cardilogia de Triangulo Mineiro, Minas Gerais, Brazil.'}, {'ForeName': 'Kui H', 'Initials': 'KH', 'LastName': 'Sim', 'Affiliation': 'Sarawak Heart Centre, Sarawak, Malaysia.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Abizaid', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28483']
2934,31445345,"A randomized, double-blind, 6-week prospective pilot study on the efficacy and safety of dose escalation in non-remitters in comparison to those of the standard dose of escitalopram for major depressive disorder.","BACKGROUND


Escalating doses of selective serotonin reuptake inhibitors are often used to treat patients with a suboptimal response to the standard dose. This study assessed the efficacy and safety of dose escalation of escitalopram, up to 30 mg, in non-remitters with major depressive disorder (MDD) after treatment with the standard dose.
METHOD


We recruited 98 patients with MDD (aged 18-65 years). After 4 weeks of open-label treatment with 10-20 mg of escitalopram per day, non-remitters [Montgomery-Åsberg Depression Rating Scale (MADRS) score > 10] were randomized 1:1 for double-blind treatment with either escitalopram (30 mg per day) or escitalopram (20 mg per day) plus placebo for 6 weeks. The primary efficacy outcome was a change in the total MADRS score.
RESULTS


After 4 weeks of open-label treatment, 12 patients achieved remission, and 36 dropped out, leaving 50 non-remitters, of whom 44 (88%) completed the double-blind study. The primary outcome measure, the least-squares mean (standard error) change in the total MADRS score at week 6 was significantly different (p = 0.046) between the groups [-8.0 (1.2) in the placebo dose-escalation and -11.8 (1.2) in the escitalopram dose-escalation]. The dose escalation of escitalopram was well tolerated. However, the response and remission rates and quality of life showed no significant differences.
LIMITATIONS


Small sample size and short follow-up period CONCLUSION: This study suggests that dose escalation of escitalopram up to 30 mg per day may be beneficial for the treatment of depressive symptoms in non-remitters after standard (10-20 mg/day) treatment.",2019,"However, the response and remission rates and quality of life showed no significant differences.
","['for major depressive disorder', 'non-remitters with major depressive disorder (MDD) after treatment with the standard dose', '98 patients with MDD (aged 18-65 years']","['placebo', 'open-label treatment with 10-20\u202fmg of escitalopram per day, non-remitters [Montgomery-Åsberg Depression Rating Scale (MADRS) score\xa0>\xa010', 'escitalopram', 'escitalopram (30\u202fmg per day) or escitalopram']","['depressive symptoms', 'total MADRS score', 'least-squares mean (standard error) change in the total MADRS score', 'response and remission rates and quality of life', 'efficacy and safety', 'tolerated']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",98.0,0.297506,"However, the response and remission rates and quality of life showed no significant differences.
","[{'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Kim', 'Affiliation': 'Mental Health Center, Seoul National University Health Care Center, 1 Gwanak-ro, Gwanak-gu, Seoul 08826, Republic of Korea; Department of Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul 03080, Republic of Korea.'}, {'ForeName': 'Se Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Seoul National University Hospital, 103 Daehak-ro, Jongno-gu, Seoul 03080, Republic of Korea; Department of Psychiatry and Behavioral Science, Institute of Human Behavioral Medicine, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul 03080, Republic of Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Mental Health Clinic, National Cancer Center, Ilsandong-gu, Goyang-si, Gyeonggi-do 10326, Republic of Korea; Cancer Survivorship Branch, National Cancer Control Institute, National Cancer Center, Ilsandong-gu, Goyang-si, Gyeonggi-do 10326, Republic of Korea.'}, {'ForeName': 'Nam Young', 'Initials': 'NY', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Dongguk University International Hospital, Dongguk University Medical School, 27 Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do 10326, Republic of Korea.'}, {'ForeName': 'Hye Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Inha University Hospital, 27 Inhang-ro, Jung-gu, Incheon 22332, Republic of Korea.'}, {'ForeName': 'C Hyung Keun', 'Initials': 'CHK', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Institute of Human Behavioral Medicine, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul 03080, Republic of Korea; Department of Psychiatry, Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea.'}, {'ForeName': 'Yong Min', 'Initials': 'YM', 'LastName': 'Ahn', 'Affiliation': 'Department of Psychiatry, Seoul National University Hospital, 103 Daehak-ro, Jongno-gu, Seoul 03080, Republic of Korea; Department of Psychiatry and Behavioral Science, Institute of Human Behavioral Medicine, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul 03080, Republic of Korea. Electronic address: aym@snu.ac.kr.'}]",Journal of affective disorders,['10.1016/j.jad.2019.08.057']
2935,31474753,Low-intensity shockwave therapy (LiST) for erectile dysfunction: a randomized clinical trial assessing the impact of energy flux density (EFD) and frequency of sessions.,"The impact of energy flux density (EFD) used on low-intensity shockwave therapy (LiST) for erectile dysfunction (ED) has not been explored. Our aim was to compare EFD 0.05 versus 0.10 mJ/mm 2  regarding efficacy and safety of 12-treatment sessions when applied two or three times per week. Ninety-seven patients with vasculogenic ED, PDE5 inhibitors users were randomized into four groups, to receive 12 LiST sessions. Group A (n = 24) : two sessions per week, EFD 0.05 mJ/mm 2 ; Group B (n = 24): three sessions per week, EFD 0.05 mJ/mm 2 ; Group C (n = 24): two sessions per week, EFD 0.10 mJ/mm 2 ; Group D (n = 25): three sessions per week, EFD 0.10 mJ/mm 2 . International Index for Erectile Function-Erectile Function domain (IIEF-EF), Minimally clinical important differences (MCID), sexual encounter profile, and triplex ultrasonography parameters were used to asses erectile function. Eighty-nine patients completed the 6-month follow-up (FU). All four groups improved in mean IIEF-EF score, average SEP3 ""Yes"" response rates at 6-month FU visit compared with baseline (p < 0.001). MCID at 6-month FU visit was achieved in 82.6%, 77.3%, 87%, and 81% in Groups A, B, C, and D, respectively. Mean PSV (cm/s) at baseline versus 3-month FU visit were 30.32 versus 34.67 for Group A, 30.02 versus 35.02 for Group B, 30.2 versus 36.02, for Group C, 29.43 versus 34.3 for Group D (p < 0.01). There were no statistical significant differences in the change of all outcome measures assessing erectile function between different sessions frequency. A tendency for better efficacy using EFD 0.10 mJ/mm 2  was noticed, although it did not reach statistical significance. No treatment-related side-effects were reported. This study lacks a sham-controlled arm. However, all patients were randomized to the four groups, and baseline characteristics were similar between the groups. Moreover, arterial insufficiency was confirmed among all patients by penile triplex ultrasonography. Conclusively, patients may benefit equally when sessions are applied either two or three per week. An EFD of 0.10 mJ/mm 2  could result in better outcomes, but further studies are needed to validate this observation.",2020,There were no statistical significant differences in the change of all outcome measures assessing erectile function between different sessions frequency.,"['erectile dysfunction', 'Ninety-seven patients with vasculogenic ED, PDE5 inhibitors users', 'Eighty-nine patients completed the 6-month follow-up (FU']","['energy flux density (EFD) used on low-intensity shockwave therapy (LiST', 'Low-intensity shockwave therapy (LiST', 'energy flux density (EFD']","['arterial insufficiency', 'MCID at 6-month FU visit', 'mean IIEF-EF score, average SEP3 ""Yes"" response rates', 'Mean PSV', 'erectile function']","[{'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1318700', 'cui_str': 'PDE5 Inhibitors'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003834', 'cui_str': 'Arterial insufficiency (disorder)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0031843', 'cui_str': 'function'}]",97.0,0.043468,There were no statistical significant differences in the change of all outcome measures assessing erectile function between different sessions frequency.,"[{'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kalyvianakis', 'Affiliation': '1st Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Mykoniatis', 'Affiliation': '1st Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece. g_mikoniatis@hotmail.com.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Memmos', 'Affiliation': '1st Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Paraskevi', 'Initials': 'P', 'LastName': 'Kapoteli', 'Affiliation': '1st Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Memmos', 'Affiliation': '1st Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Hatzichristou', 'Affiliation': '1st Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}]",International journal of impotence research,['10.1038/s41443-019-0185-0']
2936,32434237,Magnesium Sulfate Combined with a Levobupivacaine Periarticular Cocktail for Analgesia in the Early Postoperative Period after Total Knee Arthroplasty.,"This study aimed to evaluate the analgesic effect of magnesium sulfate combined with a levobupivacaine periarticular cocktail in the early postoperative period after total knee arthroplasty (TKA). A total of 60 patients who underwent primary unilateral TKA in our department from March 2018 to May 2019 were prospectively selected and randomly divided into the trial group (30 patients with 20 mL of magnesium sulfate 250 mg + levobupivacaine 50 mg + triamcinolone 25 mg + 0.9% normal saline) and the control group (30 patients with 20 mL of levobupivacaine 50 mg + triamcinolone 25 mg + 0.9% normal saline). Visual analog scale (VAS) scores at 6, 12, 24, 48, and 72 hours postoperatively during rest; VAS scores at 12, 24, 48, and 72 hours postoperatively during motion; the time required to reach 30 degrees straight leg elevation and 60 degrees active knee flexion; and the analgesia pump dosage at 6, 12, 24, and 48 hours postoperatively were recorded. Magnesium sulfate combined with levobupivacaine injection around the knee joint can significantly prolong the time of postoperative analgesia, significantly reduce the use of postoperative analgesics, and effectively alleviate early postoperative pain after TKA.",2020,"Magnesium sulfate combined with levobupivacaine injection around the knee joint can significantly prolong the time of postoperative analgesia, significantly reduce the use of postoperative analgesics, and effectively alleviate early postoperative pain after TKA.","['60 patients who underwent primary unilateral TKA in our department from March 2018 to May 2019', 'total knee arthroplasty (TKA', 'Total Knee Arthroplasty']","['Magnesium Sulfate Combined with a Levobupivacaine Periarticular Cocktail', 'Magnesium sulfate combined with levobupivacaine injection', 'magnesium sulfate', 'magnesium sulfate 250\u2009mg\u2009+\u2009levobupivacaine 50\u2009mg\u2009+\u2009triamcinolone 25\u2009mg\u2009+\u20090.9% normal saline', 'levobupivacaine 50\u2009mg\u2009+\u2009triamcinolone 25\u2009mg\u2009+\u20090.9% normal saline', 'levobupivacaine periarticular cocktail']","['Visual analog scale (VAS) scores', 'time of postoperative analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",60.0,0.080559,"Magnesium sulfate combined with levobupivacaine injection around the knee joint can significantly prolong the time of postoperative analgesia, significantly reduce the use of postoperative analgesics, and effectively alleviate early postoperative pain after TKA.","[{'ForeName': 'Zhenrui', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopedics, Wuhan University of Science and Technology, Xiaogan, Hubei, China.'}, {'ForeName': 'Xiaozhou', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Wuhan University of Science and Technology, Xiaogan, Hubei, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': 'Department of Orthopedics, Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, North Sichuan Medical College, Nanchong, Sichuan, China.'}, {'ForeName': 'Hengzhong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, Wuhan University of Science and Technology, Xiaogan, Hubei, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics, Wuhan University of Science and Technology, Xiaogan, Hubei, China.'}]",The journal of knee surgery,['10.1055/s-0040-1710364']
2937,32434067,"Gastrointestinal Eosinophil Responses in a Longitudinal, Randomized Trial of Peanut Oral Immunotherapy.","BACKGROUND & AIMS


Gastrointestinal side effects are common during oral immunotherapy (OIT) and eosinophilic esophagitis (EoE) is a potential complication. We aimed to characterize eosinophilic gastrointestinal responses to peanut OIT, in which peanut protein is given orally, with incremental increases in dose over time.
METHODS


Twenty adults with IgE-mediated peanut allergy were randomly assigned to groups given peanut OIT (n=15) or placebo (n=5); 1 additional subject withdrew before randomization. Serial gastrointestinal biopsies were collected at baseline (n=21, 0 weeks), following dose escalation (n=10, 52 weeks), and during the maintenance phase (n=11, 104 weeks). Endoscopic findings were characterized using the EoE endoscopic reference score. Biopsies were assessed for eosinophils per high-power field (eos/hpf) and other pathology features using EoE histologic scoring system scores. We performed immunohistochemical analyses of eosinophil peroxidase deposition, quantified using automated image analysis.
RESULTS


At baseline, no subjects reported current gastrointestinal symptoms. However, 3 of the 21 subjects (14%) had esophageal peak eosinophil counts ≥15 eos/hpf and all subjects had dilated intercellular spaces (DIS). OIT induced or exacerbated esophageal eosinophilia (EE) at 52 weeks in most subjects (peak eosinophil counts >5 eos/hpf in 6 of 7 patients [86%]; peak eosinophil counts ≥15 eos/hpf in 4 of 7 patients [57%]). One subject met clinicopathologic criteria for EoE and withdrew; no significant changes in esophageal peak eosinophil counts were observed in the placebo group. EE in the OIT group corresponded with significant increases in EoE histologic scoring system scores and deposition of eosinophil peroxidase. In 4 of 6 participants (67%), OIT-induced EE and gastrointestinal eosinophilia resolved by the end of the maintenance phase. Gastrointestinal symptoms were not clearly associated with EE or gastrointestinal eosinophilia.
CONCLUSIONS


In this pilot study, we found that peanut OIT-induced EE and gastrointestinal eosinophilia are usually transient and are not always associated with gastrointestinal symptoms. Clinicaltrials.gov no: NCT02103270.",2020,EE in the OIT group corresponded with significant increases in EoE histologic scoring system scores and deposition of eosinophil peroxidase.,['Twenty adults with IgE-mediated peanut allergy'],"['placebo', 'peanut OIT', 'Peanut Oral Immunotherapy']","['current gastrointestinal symptoms', 'esophageal peak eosinophil counts', 'EoE histologic scoring system scores and deposition of eosinophil peroxidase', 'OIT-induced EE and gastrointestinal eosinophilia', 'OIT induced or exacerbated esophageal eosinophilia (EE', 'peak eosinophil counts', 'Serial gastrointestinal biopsies', 'Gastrointestinal Eosinophil Responses', 'Gastrointestinal symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0014457', 'cui_str': 'Eosinophilia'}, {'cui': 'C1262481', 'cui_str': 'Eosinophilic gastroenteritis'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",20.0,0.256431,EE in the OIT group corresponded with significant increases in EoE histologic scoring system scores and deposition of eosinophil peroxidase.,"[{'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Wright', 'Affiliation': ""Division of Allergy, Asthma, and Clinical Immunology, Department of Medicine, Mayo Clinic Arizona, Scottsdale, AZ, United States; Division of Pulmonology, Phoenix Children's Hospital, Phoenix, AZ, United States.""}, {'ForeName': 'Nielsen Q', 'Initials': 'NQ', 'LastName': 'Fernandez-Becker', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Neeraja', 'Initials': 'N', 'LastName': 'Kambham', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States; Department of Pathology, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Purington', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Tupa', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Wenming', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Sayantani B', 'Initials': 'SB', 'LastName': 'Sindher', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Rank', 'Affiliation': ""Division of Allergy, Asthma, and Clinical Immunology, Department of Medicine, Mayo Clinic Arizona, Scottsdale, AZ, United States; Division of Pulmonology, Phoenix Children's Hospital, Phoenix, AZ, United States.""}, {'ForeName': 'Hirohito', 'Initials': 'H', 'LastName': 'Kita', 'Affiliation': 'Division of Allergy, Asthma, and Clinical Immunology, Department of Medicine, Mayo Clinic Arizona, Scottsdale, AZ, United States; Department of Immunology, Mayo Clinic Arizona, Scottsdale, AZ, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Katzka', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Kelly P', 'Initials': 'KP', 'LastName': 'Shim', 'Affiliation': ""Division of Allergy, Asthma, and Clinical Immunology, Department of Medicine, Mayo Clinic Arizona, Scottsdale, AZ, United States; Division of Pulmonology, Phoenix Children's Hospital, Phoenix, AZ, United States.""}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Bunning', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Alfred D', 'Initials': 'AD', 'LastName': 'Doyle', 'Affiliation': 'Division of Allergy, Asthma, and Clinical Immunology, Department of Medicine, Mayo Clinic Arizona, Scottsdale, AZ, United States.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Jacobsen', 'Affiliation': 'Division of Allergy, Asthma, and Clinical Immunology, Department of Medicine, Mayo Clinic Arizona, Scottsdale, AZ, United States; Department of Immunology, Mayo Clinic Arizona, Scottsdale, AZ, United States.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States; Department of Pathology, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Boyd', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States; Department of Pathology, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Monali', 'Initials': 'M', 'LastName': 'Manohar', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'R Sharon', 'Initials': 'RS', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States. Electronic address: schinths@stanford.edu.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.05.019']
2938,32434104,Effect of the mobile phone-related background on inhibitory control of problematic mobile phone use: An event-related potentials study.,"The present study aims to provide electrophysiological evidence for deficient inhibitory control in problematic mobile phone use and to investigate whether reduced inhibition is more pronounced during exposure to a mobile phone related background cue. A screen scale of smartphone addiction was completed by 227 college students, and finally an experimental group and a control group consisting of 20 problematic mobile phone users and 19 controls were included in the study. Event-related potentials were recorded during a backgrounded Go/NoGo task performed by those two groups, in which either a frequent Go signal (letter ""M"") or a rare NoGo signal (letter ""W"") was superimposed on three different background cues: neutral, mobile phone application-related and mobile phone using-related pictures. Results showed that problematic mobile phone users performed more commission errors than controls following mobile phone application background. Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background. The result might suggest that there is no general impairment of inhibitory control in problematic mobile phone use. The deficient inhibitory control on behavioral and psychophysiological level appeared merely in the mobile phone-related background. Such deficient stimuli-specific inhibitory control appears at the late stage of inhibitory control. Prevention programs should be designed to curtail exposure to the mobile phone-related stimulus and enhance cognitive control of potential problematic mobile phone users.",2020,"Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background.","['227 college students, and finally an experimental group and a control group consisting of 20 problematic mobile phone users and 19 controls were included in the study']",['mobile phone-related background'],"['behavioral and psychophysiological level', 'commission errors', 'NoGo P3 amplitude']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0394788,"Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background.","[{'ForeName': 'Lingfeng', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Jingfu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': 'School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Qingbai', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Zongkui', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China. Electronic address: zhouzk@mail.ccnu.edu.cn.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106363']
2939,32434236,Patellar Resurfacing Does Not Improve Clinical Outcome in Patients with Symptomatic Tricompartmental Knee Osteoarthritis. An RCT Study of 40 Patients Receiving Primary Cruciate Retaining Total Knee Arthroplasty.,"There is some evidence that patellofemoral (PF) joint osteoarthritis (OA) causes anterior knee pain (AKP) after total knee arthroplasty (TKA). We hypothesized that patellar resurfacing in primary TKA for patients with symptomatic tricompartmental knee OA yields better clinical results after 2 years than non-resurfacing. A single center randomized controlled clinical trial comparing 40 patients receiving 42 cruciate retaining TKAs with ( n  = 21) or without patellar resurfacing ( n  = 21) was conducted. Primary outcome was the specific PF joint score HSS Baldini and secondary outcomes were the Knee Society Score (KSS) and the Knee Osteoarthritis Outcome Scale (KOOS). After 2 years no significant differences between both groups and between the groups in time for HSS Baldini, KSS, and KOOS were found. HSS Baldini score improved significantly after 6 weeks in both groups ( p  < 0.001) and did not improve in time afterward. At final follow-up the HSS Baldini mean score improved from a preoperative mean of 39 to 88 (difference of 49 points;  p  < 0.001)) for without patellar resurfacing group, and from a preoperative mean of 37 to 81 for patellar resurfacing group (difference of 47 points;  p  < 0.001). One patient in the patellar resurfacing group underwent a soft tissue re-alignment procedure because of patellar subluxation. Two patients in without patellar resurfacing group received secondary patellar button placement. Patellar resurfacing in primary TKA for patients with symptomatic tricompartmental OA has no beneficial effect over non-resurfacing and seems unnecessary. A special PF joint outcome measurement tool (HSS Baldini) and common knee scores showed no better knee function or AKP outcomes for with patellar resurfacing over without patellar resurfacing group in time and after 2 years of follow-up.",2020,"After 2 years no significant differences between both groups and between the groups in time for HSS Baldini, KSS, and KOOS were found.","['patients with symptomatic tricompartmental OA', 'patellofemoral (PF) joint osteoarthritis (OA) causes anterior knee pain (AKP) after total knee arthroplasty (TKA', '40 Patients Receiving Primary Cruciate Retaining Total Knee Arthroplasty', '40 patients receiving 42 cruciate retaining TKAs with ( n \u2009=\u200921) or without patellar resurfacing ( n \u2009=\u200921', 'Patients with Symptomatic Tricompartmental Knee Osteoarthritis']","['soft tissue re-alignment procedure because of patellar subluxation', 'Patellar Resurfacing', 'patellar resurfacing over without patellar resurfacing', 'Patellar resurfacing', 'patellar resurfacing', 'secondary patellar button placement']","['HSS Baldini score', 'time for HSS Baldini, KSS, and KOOS', 'specific PF joint score HSS Baldini and secondary outcomes were the Knee Society Score (KSS) and the Knee Osteoarthritis Outcome Scale (KOOS', 'HSS Baldini mean score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0447801', 'cui_str': 'Structure of patellofemoral joint'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0332768', 'cui_str': 'Subluxation of joint'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0453985', 'cui_str': 'Button'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0714239,"After 2 years no significant differences between both groups and between the groups in time for HSS Baldini, KSS, and KOOS were found.","[{'ForeName': 'Tom M van', 'Initials': 'TMV', 'LastName': 'Raaij', 'Affiliation': 'Department of Orthopedic Surgery, Martini Hospital Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Evelien van der', 'Initials': 'EV', 'LastName': 'Meij', 'Affiliation': 'Department of Orthopedic Surgery, Martini Hospital Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Astrid J de', 'Initials': 'AJ', 'LastName': 'Vries', 'Affiliation': 'Department of Orthopedic Surgery, Martini Hospital Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jos J A M van', 'Initials': 'JJAMV', 'LastName': 'Raay', 'Affiliation': 'Department of Orthopedic Surgery, Martini Hospital Groningen, Groningen, The Netherlands.'}]",The journal of knee surgery,['10.1055/s-0040-1710369']
2940,32434238,Additional Insulin for Coping with Fat- and Protein-Rich Meals in Adolescents with Type 1 Diabetes: The Protein Unit.,"OBJECTIVE


Dietary proteins raise blood glucose levels; dietary fats delay this rise. We sought to assess the insulin amount required to normalize glucose levels after a fat- and protein-rich meal (FPRM).
METHODS


Sixteen adolescents (5 female) with type 1 diabetes (median age: 18.2 years; range: 15.2-24.0; duration: 7.1 years; 2.3-14.3; HbA1c: 7.2%; 6.2-8.3%) were included. FPRM (carbohydrates 57 g; protein 92 g; fat 39 g; fibers 7 g; calories 975 Kcal) was served in the evening, with 20 or 40% extra insulin compared to a standard meal (SM) (carbohydrates 70 g; protein 28 g; fat 19 g; fibers 10 g; calories 579 Kcal) or carbohydrates only. Insulin was administered for patients on intensified insulin therapy or as a 4-hour-delayed bolus for those on pump therapy. The 12-hour post-meal glucose levels were compared between FPRM and SM, with the extra insulin amount calculated based on 100 g proteins as a multiple of the carbohydrate unit.
RESULTS


Glucose levels (median, mg/dL) 12-hour post-meal with 20% extra insulin vs. 40% vs. insulin dose for SM were 116 vs. 113 vs. 91. Glucose-AUC over 12-hour post-meal with 20% extra insulin vs. 40% vs. insulin dose for SM was 1603 mg/dL/12 h vs. 1527 vs. 1400 (no significance). Glucose levels in the target range with 20% extra insulin vs. 40% were 60% vs. 69% (p=0.1). Glucose levels <60 mg/dL did not increase with 40% extra insulin. This corresponds to the 2.15-fold carbohydrate unit for 100 g protein.
CONCLUSIONS


We recommend administering the same insulin dose given for 1 carbohydrate unit (10 g carbs) to cover 50 g protein.",2020,Glucose levels <60 mg/dL did not increase with 40% extra insulin.,"['Sixteen adolescents (5 female) with type 1 diabetes (median age: 18.2 years; range: 15.2-24.0; duration: 7.1 years; 2.3-14.3; HbA1c: 7.2%; 6.2-8.3%) were included', 'Adolescents with Type 1 Diabetes']","['Insulin', 'carbohydrates 57\u2009g; protein 92\u2009g; fat 39\u2009g; fibers 7\u2009g; calories 975\u2009Kcal) was served in the evening, with 20 or 40% extra insulin compared to a standard meal (SM', 'FPRM', 'Additional Insulin for Coping with Fat- and Protein-Rich Meals', 'carbohydrates 70\u2009g; protein 28\u2009g; fat 19\u2009g; fibers 10\u2009g; calories 579\u2009Kcal) or carbohydrates only']","['Glucose-AUC', 'Glucose levels']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C4517911', 'cui_str': '975'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0444664', 'cui_str': 'Standard meal'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0444661', 'cui_str': 'Protein-rich meal'}, {'cui': 'C3164740', 'cui_str': '28 gauge'}, {'cui': 'C0470539', 'cui_str': '19G'}, {'cui': 'C1318182', 'cui_str': '10G'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",,0.0183557,Glucose levels <60 mg/dL did not increase with 40% extra insulin.,"[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Schweizer', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetology, Pediatric University Hospital, Tübingen, Germany.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Herrlich', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetology, Pediatric University Hospital, Tübingen, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Lösch-Binder', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetology, Pediatric University Hospital, Tübingen, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Glökler', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetology, Pediatric University Hospital, Tübingen, Germany.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Heimgärtner', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetology, Pediatric University Hospital, Tübingen, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Liebrich', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetology, Pediatric University Hospital, Tübingen, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Meßner', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetology, Pediatric University Hospital, Tübingen, Germany.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Muckenhaupt', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Klinikum am Steinenberg, Reutlingen, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Schneider', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetology, Pediatric University Hospital, Tübingen, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Ziegler', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetology, Pediatric University Hospital, Tübingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Neu', 'Affiliation': 'Department of Pediatric Endocrinology and Diabetology, Pediatric University Hospital, Tübingen, Germany.'}]","Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association",['10.1055/a-1149-8766']
2941,32434151,A Pilot Study on the Effects of Yi Jin Jing Exercise for Older Men with Benign Prostatic Hyperplasia.,"Benign prostatic hyperplasia and its associated lower urinary tract symptoms seriously affect both the physical and mental health of older men. In order to determine the efficiency of Chinese Qigong Yi Jin Jing on prostate health in older individuals, thirty participants were randomized into either an Yi Jin Jing group (n = 15) or a control group (n = 15). After the 6-month intervention, the Yi Jin Jing group showed a significant decrease in international prostate symptom score and a significant increase in maximal urinary flow rate (compared with the control group p = .005, p = .001, respectively). Also, testosterone level increased and estrogen/testosterone ratio decreased in the Yi Jin Jing group (compared with the baseline p = .004, p = .002, respectively); estrogen level and estrogen/testosterone ratio were lower in the Yi Jin Jing group (compared with the control group p = .029, p = .012, respectively). The results showed that Yi Jin Jing is a promising way to reduce the risk of benign prostatic hyperplasia-lower urinary tract symptoms in older men.",2020,The results showed that Yi Jin Jing is a promising way to reduce the risk of benign prostatic hyperplasia-lower urinary tract symptoms in older men.,"['older individuals, thirty participants', 'Older Men with Benign Prostatic Hyperplasia', 'older men']","['Chinese Qigong Yi Jin Jing', 'Yi Jin Jing Exercise']","['maximal urinary flow rate', 'estrogen level and estrogen/testosterone ratio', 'testosterone level increased and estrogen/testosterone ratio', 'risk of benign prostatic hyperplasia-lower urinary tract symptoms', 'international prostate symptom score']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0429784', 'cui_str': 'Maximal urinary flow rate'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}]",30.0,0.0388005,The results showed that Yi Jin Jing is a promising way to reduce the risk of benign prostatic hyperplasia-lower urinary tract symptoms in older men.,"[{'ForeName': 'ZhiWei', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Mingkang', 'Initials': 'M', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'ChunJie', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Antonnette', 'Initials': 'A', 'LastName': 'Ketlhoafetse', 'Affiliation': ''}, {'ForeName': 'XiangYun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0315']
2942,32434234,Topical Tranexamic Acid in Total Knee Arthroplasty: Does It Augment the Effect of the Intravenous Administration in Patients with Moderate-to-High Risk of Bleeding? A Randomized Clinical Trial.,"This study aimed to compare the superimposed clinical value of topical tranexamic acid (TXA) application when it is simultaneously combined with intravenous (IV) administration versus the use of either IV TXA alone or IA TXA alone during primary total knee arthroplasty (TKA) in patients with moderate-to-high risk of bleeding. We hypothesized that the combined administration approach will result in a more adequate reduction in the perioperative blood loss and blood transfusion rate. Ninety-four patients undergoing primary TKA were randomly allocated into intra-articular (IA) alone, IV alone, and combined group. We used 2 g of IV TXA in the IV TXA alone and combined groups 10 minutes before tourniquet deflation. However, we applied 1.5 g TXA in 100 mL isotonic saline half topically before arthrotomy closure and half retrogradely after wound closure through the drain. Follow-up period was 6 weeks. The primary outcome measures included the drainage blood volume, total blood loss, hidden blood loss, intraoperative blood loss, and the allogenic transfusion rate. Secondary outcomes included postoperative hemoglobin drop, amount of transfused blood units, thromboembolism, and wound complications. Combined administration of TXA provided significantly better results in terms of blood volume collected by the drain, total blood loss, and hidden blood loss ( p  < 0.01). Contrarily, the intraoperative blood loss, the allogeneic transfusion rate, and the number of transfused units were similar in all groups ( p  > 0.05). The subgroup analysis revealed that a combined IA and IV TXA administration significantly reduced the total blood loss in patients with either moderate or high risk of bleeding. Moreover, the degree of hemoglobin drop was significantly lesser with the combined approach. No thromboembolic complications or wound infection occurred. In conclusion, the combined use of topical and IV tranexamic acid resulted in a significant reduction in postoperative blood loss and hemoglobin level following TKA but did not influence the rate of allogeneic blood transfusion. This is a Level I, therapeutic study.",2020,"Combined administration of TXA provided significantly better results in terms of blood volume collected by the drain, total blood loss, and hidden blood loss ( p  < 0.01).","['Total Knee Arthroplasty', 'Ninety-four patients undergoing primary TKA', 'patients with moderate-to-high risk of bleeding', 'Patients with Moderate-to-High Risk of Bleeding', 'patients with either moderate or high risk of bleeding']","['IV TXA', 'TXA', 'topical tranexamic acid (TXA', 'TXA alone or IA TXA alone', 'topical and IV tranexamic acid', 'isotonic saline', 'Topical Tranexamic Acid']","['perioperative blood loss and blood transfusion rate', 'total blood loss', 'rate of allogeneic blood transfusion', 'intraoperative blood loss, the allogeneic transfusion rate, and the number of transfused units', 'postoperative blood loss and hemoglobin level', 'degree of hemoglobin drop', 'total blood loss, and hidden blood loss', 'postoperative hemoglobin drop, amount of transfused blood units, thromboembolism, and wound complications', 'blood volume', 'drainage blood volume, total blood loss, hidden blood loss, intraoperative blood loss, and the allogenic transfusion rate', 'thromboembolic complications or wound infection']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4039184', 'cui_str': 'High risk of bleeding'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439184', 'cui_str': 'Units of blood'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}]",94.0,0.148938,"Combined administration of TXA provided significantly better results in terms of blood volume collected by the drain, total blood loss, and hidden blood loss ( p  < 0.01).","[{'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Abdallah', 'Affiliation': 'Department of Orthopedic Surgery and Trauma, Suez Canal University Hospitals, Ismailia, Egypt.'}, {'ForeName': 'Asser A', 'Initials': 'AA', 'LastName': 'Sallam', 'Affiliation': 'Department of Orthopedic Surgery and Trauma, Suez Canal University Hospitals, Ismailia, Egypt.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Arafa', 'Affiliation': 'Department of Orthopaedic Surgery, Fayoum University Hospital, Fayoum, Egypt.'}, {'ForeName': 'Ayman T', 'Initials': 'AT', 'LastName': 'Henawy', 'Affiliation': 'Department of Orthopedic Surgery and Trauma, Suez Canal University Hospitals, Ismailia, Egypt.'}]",The journal of knee surgery,['10.1055/s-0040-1710549']
2943,32434204,"A Prospective, Randomized, Open-Label Trial of Atorvastatin versus Rosuvastatin in the Prevention of Contrast-Induced Acute Kidney Injury, Worsened Renal Function at 30 Days, and Clinical Events After Acute Coronary Angiography: the PRATO-ACS-2 Study.","BACKGROUND/AIMS


Both high-dose atorvastatin and rosuvastatin have been shown to reduce contrast-induced acute kidney injury (AKI) occurrence and improve clinical outcomes in high-risk coronary patients undergoing angiographic procedures. However, there is a lack of head-to-head comparative studies on the effects of atorvastatin or rosuvastatin administered upon hospital admission in statin-naive patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS).
METHODS


In this open-label, noninferiority study, we compared changes in renal function in 709 NSTE-ACS patients randomized to atorvastatin (80 mg upon admission followed by 40 mg/day) or rosuvastatin (40 mg upon admission followed by 20 mg/day). The primary end point was AKI (increase in serum creatinine ≥0.5 mg/dL or ≥25% above baseline within 72 h). Worsening renal function (WRF) (decrease of ≥25% in the glomerular filtration rate from baseline to 30 days), 30-day major adverse cardiovascular events, and 12-month myocardial infarction (MI) or death were also evaluated.
RESULTS


The AKI incidence was similar in the 2 groups (i.e., 8.2% with rosuvastatin and 7.6% with atorvastatin; absolute risk difference = 0.54; 90% CI -3.9 to 2.8), satisfying the noninferiority criteria. WRF occurred in 53 (7.5%) patients, 19 (34%) of whom had developed AKI. The rates of WRF and adverse events at 30 days and at 12 months did not differ significantly between the 2 groups. Both AKI and WRF were found to be closely associated with the 12-month cardiovascular outcome irrespectively of statin choice.
CONCLUSIONS


High-dose rosuvastatin or atorvastatin started upon hospital admission led to similar rates of AKI, 30-day renal function changes, and 12-month death or MI in NSTE-ACS patients who underwent an early invasive strategy (clinical trial registration: https://www.clinicaltrials.gov; unique identifier: NCT01870804).",2020,The rates of WRF and adverse events at 30 days and at 12 months did not differ significantly between the 2 groups.,"['709 NSTE-ACS patients randomized to', 'statin-naive patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS', 'high-risk coronary patients undergoing angiographic procedures']","['Atorvastatin versus Rosuvastatin', 'atorvastatin', 'rosuvastatin', 'rosuvastatin or atorvastatin', 'atorvastatin and rosuvastatin', 'atorvastatin or rosuvastatin']","['Worsening renal function (WRF', 'rates of AKI, 30-day renal function changes, and 12-month death or MI', '30-day major adverse cardiovascular events, and 12-month myocardial infarction (MI) or death', 'rates of WRF and adverse events', 'AKI (increase in serum creatinine ≥0.5', 'WRF', 'AKI incidence']","[{'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.044536,The rates of WRF and adverse events at 30 days and at 12 months did not differ significantly between the 2 groups.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Toso', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy, anna.toso@libero.it.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Leoncini', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Maioli', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Tropeano', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Villani', 'Affiliation': 'Section of Biostatistics and Clinical Epidemiology, Department of Public Health, Neurosciences, Experimental and Forensic Medicine, Pavia University, Pavia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bellandi', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy.'}]",Cardiorenal medicine,['10.1159/000506857']
2944,31931887,The effect of transactional analysis on the self-esteem of imprisoned women: a clinical trial.,"BACKGROUND


The imprisoned women usually have low self-esteem and suffer from various physical and mental complaints; they may suffer from feelings of emptiness, isolation, and depression. Transactional analysis (TA) is part of a comprehensive system attributed to the individual and social psychiatry for personal development of self-esteem among the imprisoned women. Therefore, the present study aimed to investigate the effect of TA group-training on the self-esteem of imprisoned women.
METHODS


This clinical trial was conducted among the imprisoned women in a prison in Southeastern Iran using pretest-posttest design. In this regard, 76 women were randomly allocated to the intervention (n = 35) and control (n = 41) groups. The TA group-training program was held for eight 90-min sessions for the intervention group. Data were collected using a demographic questionnaire and the Rosenberg's self-esteem scale (RSES). Later, all participants were evaluated before and 1 month after the intervention.
RESULTS


In pre-test, the mean scores of self-esteem were 11.8 ± 4.67 and 7.97 ± 4.52 for the intervention and control groups, respectively. These scores showed low levels of self-esteem and the difference between the two groups was significant (p = 0.001, t = - 3.61). In the post-test, the mean scores of self-esteem improved to the moderate level (22 ± 2.52) in the intervention group compared to the control group (8.92 ± 4.04). This indicates the significant improvement of self-esteem in the intervention group (p = 0.001, t = 17.15).
CONCLUSIONS


The results showed that TA group-training had a significant effect on self-esteem. Therefore, the experienced and expert counselors and psychologists are recommended to hold transactional analysis group-training courses to enhance self-esteem among women prisoners.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials, IRCT20170725035289N5 Date registered: 25/08/2018.",2020,"This indicates the significant improvement of self-esteem in the intervention group (p = 0.001, t = 17.15).
","['women prisoners', 'imprisoned women in a prison in Southeastern Iran using pretest-posttest design', 'imprisoned women', '76 women']",['TA group-training'],"['mean scores of self-esteem', 'self-esteem', 'low levels of self-esteem', ""demographic questionnaire and the Rosenberg's self-esteem scale (RSES""]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale (assessment scale)'}]",76.0,0.0406926,"This indicates the significant improvement of self-esteem in the intervention group (p = 0.001, t = 17.15).
","[{'ForeName': 'Mahya', 'Initials': 'M', 'LastName': 'Torkaman', 'Affiliation': 'Student Research Committee, Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences , Shiraz, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Farokhzadian', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Miri', 'Affiliation': 'Department of Psychiatric Nursing, School of Nursing and Midwifery, Kerman University of Medical Sciences, Haft-Bagh Highway, PO Box: 7716913555, Kerman, Iran. miri.education@gmail.com.'}, {'ForeName': 'Batool', 'Initials': 'B', 'LastName': 'Pouraboli', 'Affiliation': 'Department of pediatric and neonatal nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}]",BMC psychology,['10.1186/s40359-019-0369-x']
2945,31596518,Interleukin-18 in patients with acute coronary syndromes.,"BACKGROUND


We aimed to assess associations between circulating IL-18 concentrations and cardiovascular outcomes in patients with acute coronary syndromes (ACS).
HYPOTHESIS AND METHODS


Plasma IL-18 concentrations were measured at admission, discharge, 1 month, and 6 months in patients with ACS in the PLATelet inhibition and patient Outcomes (PLATO) trial. Associations with outcomes were evaluated with Cox regression models on the composite of CV death, spontaneous myocardial infarction (sMI), or stroke; and on CV death or sMI separately, including adjustment for clinical risk factors and biomarkers (cTnT-hs, NT-proBNP, cystatin C, CRP-hs, and GDF-15).
RESULTS


Median IL-18 concentrations at baseline, discharge, 1 month, and 6 months were 237, 283, 305, and 320 ng/L (n = 16 636). Male sex, obesity, diabetes, and plasma levels of cystatin C, GDF-15, and CRP-hs were independently associated with higher IL-18 levels. Higher baseline IL-18 levels were associated with the composite endpoint and with CV death (hazard ratio [HR] 1.05, 95% confidence interval [95% CI] 1.02-1.07 and HR 1.10, 95% CI 1.06-1.14, respectively, per 25% increase of IL-18 levels). Associations remained significant after adjustment for clinical variables but became non-significant after adjustment for all biomarkers (HR 1.01, 95% CI 0.98-1.04 and HR 1.04, 95% CI 1.00-1.08, respectively). There were no associations with sMI.
CONCLUSIONS


In ACS patients, IL-18 concentrations increased after the acute event and remained increased for 6 months. Baseline IL-18 levels were significantly associated with CV mortality, independent of clinical characteristics and indicators of renal/cardiac dysfunction but this association was attenuated after adjustment for multiple biomarkers.",2019,"Baseline IL-18 levels were significantly associated with CV mortality, independent of clinical characteristics and indicators of renal/cardiac dysfunction but this association was attenuated after adjustment for multiple biomarkers.","['patients with ACS in the PLATelet inhibition and patient Outcomes (PLATO) trial', 'patients with acute coronary syndromes', 'patients with acute coronary syndromes (ACS']",[],"['Plasma IL-18 concentrations', 'Baseline IL-18 levels', 'Median IL-18 concentrations', 'CV death', 'clinical characteristics and indicators of renal/cardiac dysfunction', 'IL-18 concentrations', 'Higher baseline IL-18 levels', 'IL-18 levels', 'composite of CV death, spontaneous myocardial infarction (sMI), or stroke; and on CV death or sMI separately, including adjustment for clinical risk factors and biomarkers (cTnT-hs, NT-proBNP, cystatin C, CRP-hs, and GDF-15']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C3277906', 'cui_str': 'Cardiac dysfunction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3538889', 'cui_str': 'Cardiac troponin T'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}]",16636.0,0.434071,"Baseline IL-18 levels were significantly associated with CV mortality, independent of clinical characteristics and indicators of renal/cardiac dysfunction but this association was attenuated after adjustment for multiple biomarkers.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Åkerblom', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Tatevik G', 'Initials': 'TG', 'LastName': 'Lakic', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Becker', 'Affiliation': 'Division of Cardiovascular Health and Disease, Heart, Lung, and Vascular Institute, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Philippe G', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Département Hospitalo-Universitaire FIRE, AP-, Paris, France.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': 'AstraZeneca Research and Development, Gothenburg, Sweden.'}, {'ForeName': 'Hugo A', 'Initials': 'HA', 'LastName': 'Katus', 'Affiliation': 'Medizinishe Klinik, Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'W Douglas', 'Initials': 'WD', 'LastName': 'Weaver', 'Affiliation': 'Henry Ford Heart and Vascular Institute, Detroit, Michigan.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Siegbahn', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical cardiology,['10.1002/clc.23274']
2946,31810829,Effects of Accessible Health Technology and Caregiver Support Posthospitalization on 30-Day Readmission Risk: A Randomized Trial.,"INTRODUCTION


Patients with chronic illness often require ongoing support postdischarge. This study evaluated a simple-to-use, mobile health-based program designed to improve postdischarge follow-up via (1) tailored communication to patients using automated calls, (2) structured feedback to informal caregivers, and (3) automated alerts to clinicians about urgent problems.
METHODS


A total of 283 patients with common medical diagnoses, including chronic obstructive pulmonary disease, coronary artery disease, pneumonia, and diabetes, were recruited from a university hospital, a community hospital, and a US Department of Veterans Affairs hospital. All patients identified an informal caregiver or ""care partner"" (CP) to participate in their postdischarge support. Patient-CP dyads were randomized to the intervention or usual care. Intervention patients received weekly automated assessment and behavior change calls. CPs received structured e-mail feedback. Outpatient clinicians received fax alerts about serious problems. Primary outcomes were 30-day readmission rate and the combined outcome of readmission/emergency department (ED) use. Information about postdischarge outpatient visits, rehospitalizations, and ED encounters was obtained from medical records.
RESULTS


Overall, 11.4% of intervention patients and 17.9% of controls were rehospitalized within 30 days postdischarge (hazard ratio [HR]: 0.59; 95% confidence interval [CI]: 0.31-1.11; p = 0.102). Compared to intervention patients with other illnesses, those with pulmonary diagnoses generated the most clinical alerts (p = 0.004). Pulmonary patients in the intervention group showed significantly reduced 30-day risk of rehospitalization relative to controls (HR: 0.31; 95% CI: 0.11-0.87; p = 0.026).
CONCLUSION


The CP intervention did not improve 30-day readmission rates overall, although post hoc analyses suggested that it may be promising among patients with pulmonary diagnoses.",2020,"Compared to intervention patients with other illnesses, those with pulmonary diagnoses generated the most clinical alerts (p = 0.004).","['Patients with chronic illness', 'Patient-CP dyads', 'All patients identified an informal caregiver or ""care partner"" (CP) to participate in their postdischarge support', 'patients with pulmonary diagnoses', '283 patients with common medical diagnoses, including chronic obstructive pulmonary disease, coronary artery disease, pneumonia, and diabetes, were recruited from a university hospital, a community hospital, and a US Department of Veterans Affairs hospital']","['CP intervention', 'Accessible Health Technology and Caregiver Support Posthospitalization', 'mobile health-based program designed to improve postdischarge follow-up via (1) tailored communication to patients using automated calls, (2) structured feedback to informal caregivers, and (3) automated alerts to clinicians about urgent problems']","['30-day risk of rehospitalization relative', '30-Day Readmission Risk', '30-day readmission rates', '30-day readmission rate and the combined outcome of readmission/emergency department (ED) use']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0752189', 'cui_str': 'Health Care Technology'}, {'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",283.0,0.0842126,"Compared to intervention patients with other illnesses, those with pulmonary diagnoses generated the most clinical alerts (p = 0.004).","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Piette', 'Affiliation': ''}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Striplin', 'Affiliation': ''}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Aikens', 'Affiliation': ''}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Nicolle', 'Initials': 'N', 'LastName': 'Marinec', 'Affiliation': ''}, {'ForeName': 'Madhura', 'Initials': 'M', 'LastName': 'Mansabdar', 'Affiliation': ''}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Lynn A', 'Initials': 'LA', 'LastName': 'Gregory', 'Affiliation': ''}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Kim', 'Affiliation': ''}]",Joint Commission journal on quality and patient safety,['10.1016/j.jcjq.2019.10.009']
2947,31472393,A 6-day combined wake and light therapy trial for unipolar depression.,"BACKGROUND


There are a dozen studies on double or triple chronotherapy in depression (sleep deprivation [wake therapy] + light therapy + sleep advance/stabilization). We investigated efficacy and feasibility of a modified triple chronotherapy protocol.
METHODS


Thirty-five hospitalized patients with moderately severe non-seasonal depressive disorder, mostly free from antidepressants, underwent a 6-day protocol consisting of partial sleep deprivation late in the second half of the night (from 4:00 to 8:00) in a light therapy room (blue-enhanced white light increased hourly from 600→1300→2200→2800 lx) alternating with recovery nights with morning light treatment from 7:00 to 8:00. Patients were randomized to wear glasses with no filter (clear, N = 19) or filtering blue wavelength (orange-appearance, light intensity diminution by ∼70%, N = 16) during the treatments. Sleep was targeted to be shifted at least 1 h earlier. Depression was scored using HDRS-17 (Hamilton Depression Rating Scale) and BDI-II (Beck Depression Inventory-II) - before and after the 6-days treatment, HDRS-6-SR - daily, and visual analogue scales (VAS) for mood and energy - several times every day.
RESULTS


Depression levels significantly declined following the first night and after 6-days treatment, with no difference between white and orange lights. Nevertheless, some superiority of white light emerged with respect to response rate (mood VAS), immediate effect during the 4-h treatment sessions (energy VAS), and expected treatment outcomes. All patients successfully advanced bedtime/wake-up (by 30-40 minutes) and resisted naps during daytime.
LIMITATIONS


Relatively small sample size.
CONCLUSIONS


The modified triple chronotherapy was well tolerated and improved depression. Light spectrum/intensity plays some role in the response.",2019,"RESULTS


Depression levels significantly declined following the first night and after 6-days treatment, with no difference between white and orange lights.","['unipolar depression', 'Thirty-five hospitalized patients with moderately severe non-seasonal depressive disorder, mostly free from antidepressants, underwent a 6-day protocol consisting of partial sleep deprivation late in the second half of the night (from 4:00 to 8:00) in a']","['wear glasses with no filter (clear, N\u202f=\u202f19) or filtering blue wavelength (orange-appearance, light intensity diminution', 'light therapy room (blue-enhanced white light increased hourly from 600→1300→2200→2800']","['Depression levels', 'HDRS-6-SR - daily, and visual analogue scales (VAS) for mood and energy - several times every day', 'Sleep', 'response rate (mood VAS', 'tolerated and improved depression', 'HDRS-17 (Hamilton Depression Rating Scale) and BDI-II (Beck Depression Inventory-II) ']","[{'cui': 'C0041696', 'cui_str': 'Unipolar Depression'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0521113', 'cui_str': 'Non-seasonal (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0558172', 'cui_str': 'Wears glasses (finding)'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0449819', 'cui_str': 'Wavelength (qualifier value)'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0563228', 'cui_str': 'White light (physical force)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}]","[{'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",35.0,0.0244468,"RESULTS


Depression levels significantly declined following the first night and after 6-days treatment, with no difference between white and orange lights.","[{'ForeName': 'Konstantin V', 'Initials': 'KV', 'LastName': 'Danilenko', 'Affiliation': 'Institute of Physiology and Basic Medicine, Timakova, 4, Novosibirsk 630117, Russia. Electronic address: kvdani@mail.ru.'}, {'ForeName': 'Maria Y', 'Initials': 'MY', 'LastName': 'Lebedinskaia', 'Affiliation': 'Institute of Physiology and Basic Medicine, Timakova, 4, Novosibirsk 630117, Russia.'}, {'ForeName': 'Evgenia V', 'Initials': 'EV', 'LastName': 'Gadetskaia', 'Affiliation': 'Institute of Physiology and Basic Medicine, Timakova, 4, Novosibirsk 630117, Russia.'}, {'ForeName': 'Alexei A', 'Initials': 'AA', 'LastName': 'Markov', 'Affiliation': 'Institute of Physiology and Basic Medicine, Timakova, 4, Novosibirsk 630117, Russia.'}, {'ForeName': 'Yana A', 'Initials': 'YA', 'LastName': 'Ivanova', 'Affiliation': 'Institute of Physiology and Basic Medicine, Timakova, 4, Novosibirsk 630117, Russia.'}, {'ForeName': 'Lyubomir I', 'Initials': 'LI', 'LastName': 'Aftanas', 'Affiliation': 'Institute of Physiology and Basic Medicine, Timakova, 4, Novosibirsk 630117, Russia; Novosibirsk State University, Novosibirsk, Russia.'}]",Journal of affective disorders,['10.1016/j.jad.2019.08.051']
2948,31388914,Family Caregiver Skills Training to Improve Experiences of Care: a Randomized Clinical Trial.,"OBJECTIVE


To evaluate the effectiveness of Helping Invested Families Improve Veterans' Experiences Study (HI-FIVES), a skills training program for caregivers of persons with functional or cognitive impairments.
DESIGN


A two-arm RCT.
SETTING


Single Veterans Affairs Medical Center.
PARTICIPANTS


Patients and their primary caregivers referred in the past 6 months to home and community-based services or geriatrics clinic.
INTERVENTION


All caregivers received usual care. Caregivers in HI-FIVES also received five training calls and four group training sessions.
MAIN MEASURES


Cumulative patient days at home 12 months post-randomization, defined as days not in an emergency department, inpatient hospital, or post-acute facility. Secondary outcomes included patients' total VA health care costs, caregiver and patient rating of the patient's experience of VA health care, and caregiver depressive symptoms.
RESULTS


Of 241 dyads, caregivers' (patients') mean age was 61 (73) years, 54% (53%) Black and 89% (4%) female. HI-FIVES was associated with a not statistically significant 9% increase in the rate of days at home (95% CI 0.72, 1.65; mean difference 1 day over 12 months). No significant differences were observed in health care costs or caregiver depressive symptoms. Model-estimated mean baseline patient experience of VA care (scale of 0-10) was 8.43 (95% CI 8.16, 8.70); the modeled mean difference between HI-FIVES and controls at 3 months was 0.29 (p = .27), 0.31 (p = 0.26) at 6 months, and 0.48 (p = 0.03) at 12 months. For caregivers, it was 8.34 (95% CI 8.10, 8.57); the modeled mean difference at 3 months was 0.28 (p = .18), 0.53 (p < .01) at 6 months, and 0.46 (p = 0.054) at 12 months.
CONCLUSIONS


HI-FIVES did not increase patients' days at home; it showed sustained improvements in caregivers' and patients' experience of VA care at clinically significant levels, nearly 0.5 points. The training holds promise in increasing an important metric of care quality-reported experience with care.",2019,"CONCLUSIONS


HI-FIVES did not increase patients' days at home; it showed sustained improvements in caregivers' and patients' experience of VA care at clinically significant levels, nearly 0.5 points.","['Patients and their primary caregivers referred in the past 6\xa0months to home and community-based services or geriatrics clinic', 'caregivers of persons with functional or cognitive impairments', 'Single Veterans Affairs Medical Center', 'mean age was 61 (73) years, 54% (53', ""Of 241 dyads, caregivers' (patients""]","['Family Caregiver Skills Training', 'usual care', 'skills training program']","['emergency department, inpatient hospital, or post-acute facility', 'HI', 'rate of days at home', ""patients' total VA health care costs, caregiver and patient rating of the patient's experience of VA health care, and caregiver depressive symptoms"", 'health care costs or caregiver depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",241.0,0.133213,"CONCLUSIONS


HI-FIVES did not increase patients' days at home; it showed sustained improvements in caregivers' and patients' experience of VA care at clinically significant levels, nearly 0.5 points.","[{'ForeName': 'Courtney Harold', 'Initials': 'CH', 'LastName': 'Van Houtven', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA. courtney.vanhoutven@duke.edu.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Smith', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Lindquist', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Chapman', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hendrix', 'Affiliation': 'School of Nursing, Duke University Medical Center, 307 Trent Drive, Box 102400, Durham, NC, 27710, USA.'}, {'ForeName': 'Susan Nicole', 'Initials': 'SN', 'LastName': 'Hastings', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Eugene Z', 'Initials': 'EZ', 'LastName': 'Oddone', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'King', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Shepherd-Banigan', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Weinberger', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 1101A McGavran-Greenberg Hall, Campus Box 7411, Chapel Hill, NC, 27599, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05209-x']
2949,31410633,"Concentration-response modeling of ECG data from early-phase clinical studies to assess QT prolongation risk of contezolid (MRX-I), an oxazolidinone antibacterial agent.","The effects of contezolid (MRX-I, an oxazolidinone antibacterial agent) on cardiac repolarization were evaluated retrospectively using a population modeling approach in a Phase I study incorporating single ascending dose, multiple ascending dose, and food effect assessments. Linear mixed effect models were used to assess the relationships between MRX-I plasma concentrations and QT/QTc/∆QTc (baseline-adjusted), in which different correction methods for heart rate have been included. The upper bound of the one-sided 95% confidence interval (CI) for predicted ∆∆QTc was < 10 ms (ms) at therapeutic doses of MRX-I. Model performance/suitability was determined using diagnostic evaluations, which indicated rationality of one-stage concentration-QT model, as well as C-QT model suggested by Garnett et al. The finding demonstrated that MRX-I may have no clinical effects on the QT interval. Concentration-QT model may be an alternative to conventional thorough QT studies.",2019,"The upper bound of the one-sided 95% confidence interval (CI) for predicted ∆∆QTc was < 10 ms (ms) at therapeutic doses of MRX-I. Model performance/suitability was determined using diagnostic evaluations, which indicated rationality of one-stage concentration-QT model, as well as C-QT model suggested by Garnett et al.",[],"['contezolid (MRX-I, an oxazolidinone antibacterial agent']","['MRX-I plasma concentrations and QT/QTc/∆QTc', 'cardiac repolarization']",[],"[{'cui': 'C2931498', 'cui_str': 'Mental Retardation, X-Linked 1'}, {'cui': 'C0887953', 'cui_str': 'Oxazolidinone'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C2931498', 'cui_str': 'Mental Retardation, X-Linked 1'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",,0.0329148,"The upper bound of the one-sided 95% confidence interval (CI) for predicted ∆∆QTc was < 10 ms (ms) at therapeutic doses of MRX-I. Model performance/suitability was determined using diagnostic evaluations, which indicated rationality of one-stage concentration-QT model, as well as C-QT model suggested by Garnett et al.","[{'ForeName': 'Junzhen', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Certara Strategic Consulting China, Shanghai, 200122, China.'}, {'ForeName': 'Yuancheng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China. zhangj_fudan@aliyun.com.'}]",Journal of pharmacokinetics and pharmacodynamics,['10.1007/s10928-019-09650-7']
2950,31573918,The Content and Nature of Narrative Comments on Swiss Physician Rating Websites: Analysis of 849 Comments.,"BACKGROUND


The majority of physician rating websites (PRWs) provide users the option to leave narrative comments about their physicians. Narrative comments potentially provide richer insights into patients' experiences and feelings that cannot be fully captured in predefined quantitative rating scales and are increasingly being examined. However, the content and nature of narrative comments on Swiss PRWs has not been examined to date.
OBJECTIVE


This study aimed to examine (1) the types of issues raised in narrative comments on Swiss PRWs and (2) the evaluation tendencies of the narrative comments.
METHODS


A random stratified sample of 966 physicians was generated from the regions of Zürich and Geneva. Every selected physician was searched for on 3 PRWs (OkDoc, DocApp, and Medicosearch) and Google, and narrative comments were collected. Narrative comments were analyzed and classified according to a theoretical categorization framework of physician-, staff-, and practice-related issues.
RESULTS


The selected physicians had a total of 849 comments. In total, 43 subcategories addressing the physician (n=21), staff (n=8), and practice (n=14) were identified. None of the PRWs' comments covered all 43 subcategories of the categorization framework; comments on Google covered 86% (37/43) of the subcategories, Medicosearch covered 72% (31/43), DocApp covered 60% (26/43), and OkDoc covered 56% (24/43). In total, 2441 distinct issues were identified within the 43 subcategories of the categorization framework; 83.65% (2042/2441) of the issues related to the physician, 6.63% (162/2441) related to the staff, and 9.70% (237/2441) related to the practice. Overall, 95% (41/43) of the subcategories of the categorization framework and 81.60% (1992/2441) of the distinct issues identified were concerning aspects of performance (interpersonal skills of the physician and staff, infrastructure, and organization and management of the practice) that are considered assessable by patients. Overall, 83.0% (705/849) of comments were classified as positive, 2.5% (21/849) as neutral, and 14.5% (123/849) as negative. However, there were significant differences between PRWs, regions, and specialty regarding negative comments: 90.2% (111/123) of negative comments were on Google, 74.7% (92/123) were regarding physicians in Zurich, and 73.2% (90/123) were from specialists.
CONCLUSIONS


From the narrative comments analyzed, it can be reported that interpersonal issues make up nearly half of all negative issues identified, and it is recommended that physicians should focus on improving these issues. The current suppression of negative comments by Swiss PRWs is concerning, and there is a need for a consensus-based criterion to be developed to determine which comments should be published publicly. Finally, it would be helpful if Swiss patients are made aware of the current large differences between Swiss PRWs regarding the frequency and nature of ratings to help them determine which PRW will provide them with the most useful information.",2019,"Overall, 83.0% (705/849) of comments were classified as positive, 2.5% (21/849) as neutral, and 14.5% (123/849) as negative.","['966 physicians was generated from the regions of Zürich and Geneva', 'In total, 43 subcategories addressing the physician (n=21), staff (n=8), and practice (n=14) were identified', 'Swiss patients']",[],"['performance (interpersonal skills of the physician and staff, infrastructure, and organization and management of the practice']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",2441.0,0.0250196,"Overall, 83.0% (705/849) of comments were classified as positive, 2.5% (21/849) as neutral, and 14.5% (123/849) as negative.","[{'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'McLennan', 'Affiliation': 'Institute of History and Ethics in Medicine, Technical University of Munich, Munich, Germany.'}]",Journal of medical Internet research,['10.2196/14336']
2951,31437703,Normalization of EEG in depression after antidepressant treatment with sertraline? A preliminary report.,"BACKGROUND


MDD patients with abnormal EEG patterns seem more likely to be non-responsive to the antidepressants escitalopram and venlafaxine, but not sertraline, than patients without EEG abnormalities. This finding suggests that patients with both MDD and abnormal EEGs may differentially respond to antidepressant treatment. In the current study, we investigated whether depressed patients with an abnormal EEG show a normalization of the EEG related to antidepressant treatment and response and whether such effect is drug specific, and whether having had early life stress (ELS) increases the chance of abnormal activity.
METHODS


Baseline and week 8 EEGs and depression symptoms were extracted from a large multicenter study (iSPOT-D, n = 1008) where depressed patients were randomized to escitalopram, sertraline, or venlafaxine-XR treatment. We calculated Odds Ratios of EEG normalization and depression response in patients with an abnormal EEG at baseline, comparing sertraline versus other antidepressants.
RESULTS


Fifty seven patients with abnormal EEGs were included. EEGs did not normalize significantly more with sertraline compared to other antidepressants (OR = 1.9, p = .280). However, patients with a normalized EEG taking sertraline were 5.2 times more likely to respond than subjects taking other antidepressants (p = .019). ELS was not significantly related to abnormal activity.
LIMITATIONS


Neurophysiological recordings were limited in time (two times 2-minute EEGs) and statistical power (n = 57 abnormal EEGs).
CONCLUSIONS


Response rates in patients with normalized EEG taking sertraline were significantly larger than in subjects treated with escitalopram/venlafaxine. This adds to personalized medicine and suggests a possible drug repurposing for sertraline.",2019,"EEGs did not normalize significantly more with sertraline compared to other antidepressants (OR = 1.9, p = .280).","['MDD patients with abnormal EEG patterns', 'Fifty', 'Baseline and week 8 EEGs and depression symptoms were extracted from a large multicenter study (iSPOT-D, n\u202f=\u202f1008) where depressed patients', 'seven patients with abnormal EEGs']","['sertraline', 'venlafaxine', 'escitalopram/venlafaxine', 'escitalopram, sertraline, or venlafaxine-XR treatment']","['Odds Ratios of EEG normalization and depression response', 'abnormal activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151611', 'cui_str': 'EEG abnormal'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",57.0,0.0305369,"EEGs did not normalize significantly more with sertraline compared to other antidepressants (OR = 1.9, p = .280).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'van der Vinne', 'Affiliation': 'Synaeda Psycho Medisch Centrum, Leeuwarden, the Netherlands; Research Institute Brainclinics, Nijmegen, the Netherlands; Department of Clinical Neurophysiology, Faculty Science and Technology, University of Twente, Enschede, the Netherlands. Electronic address: n.van.der.vinne@synaeda.nl.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Vollebregt', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, the Netherlands; Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Boutros', 'Affiliation': ""Saint Luke's Marion Bloch Neuroscience Institute, Kansas City, MO, USA.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fallahpour', 'Affiliation': 'Icahn School of Medicine, Mount Sinai, New York, USA; Brain Resource Center, New York, USA.'}, {'ForeName': 'M J A M', 'Initials': 'MJAM', 'LastName': 'van Putten', 'Affiliation': 'Department of Clinical Neurophysiology, Faculty Science and Technology, University of Twente, Enschede, the Netherlands; Department of Clinical Neurophysiology and Neurology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, the Netherlands; Department of Experimental Psychology, Utrecht University, Utrecht, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2019.08.016']
2952,31965140,"Association of egg intake with blood lipids, cardiovascular disease, and mortality in 177,000 people in 50 countries.","BACKGROUND


Eggs are a rich source of essential nutrients, but they are also a source of dietary cholesterol. Therefore, some guidelines recommend limiting egg consumption. However, there is contradictory evidence on the impact of eggs on diseases, largely based on studies conducted in high-income countries.
OBJECTIVES


Our aim was to assess the association of egg consumption with blood lipids, cardiovascular disease (CVD), and mortality in large global studies involving populations from low-, middle-, and high-income countries.
METHODS


We studied 146,011 individuals from 21 countries in the Prospective Urban Rural Epidemiology (PURE) study. Egg consumption was recorded using country-specific validated FFQs. We also studied 31,544 patients with vascular disease in 2 multinational prospective studies: ONTARGET (Ongoing Telmisartan Alone and in Combination with Ramipril Global End Point Trial) and TRANSCEND (Telmisartan Randomized Assessment Study in ACEI Intolerant Subjects with Cardiovascular Disease). We calculated HRs using multivariable Cox frailty models with random intercepts to account for clustering by study center separately within each study.
RESULTS


In the PURE study, we recorded 14,700 composite events (8932 deaths and 8477 CVD events). In the PURE study, after excluding those with history of CVD, higher intake of egg (≥7 egg/wk compared with <1 egg/wk intake) was not significantly associated with blood lipids, composite outcome (HR: 0.96; 95% CI: 0.89, 1.04; P-trend = 0.74), total mortality (HR: 1.04; 95% CI: 0.94, 1.15; P-trend = 0.38), or major CVD (HR: 0.92; 95% CI: 0.83, 1.01; P-trend = 0.20). Similar results were observed in ONTARGET/TRANSCEND studies for composite outcome (HR 0.97; 95% CI: 0.76, 1.25; P-trend = 0.09), total mortality (HR: 0.88; 95% CI: 0.62, 1.24; P-trend = 0.55), and major CVD (HR: 0.97; 95% CI: 0.73, 1.29; P-trend = 0.12).
CONCLUSIONS


In 3 large international prospective studies including ∼177,000 individuals, 12,701 deaths, and 13,658 CVD events from 50 countries in 6 continents, we did not find significant associations between egg intake and blood lipids, mortality, or major CVD events. The ONTARGET and TRANSCEND trials were registered at clinicaltrials.gov as NCT00153101. The PURE trial was registered at clinicaltrials.gov as NCT03225586.",2020,"Similar results were observed in ONTARGET/TRANSCEND studies for composite outcome (HR 0.97; 95% CI: 0.76, 1.25; P-trend = 0.09), total mortality (HR: 0.88; 95% CI: 0.62, 1.24; P-trend = 0.55), and major CVD (HR: 0.97; 95% CI: 0.73, 1.29; P-trend = 0.12).
","['ACEI Intolerant Subjects with Cardiovascular Disease', '177,000 people in 50 countries', '146,011 individuals from 21 countries in the Prospective Urban Rural Epidemiology (PURE) study', '∼177,000 individuals, 12,701 deaths, and 13,658 CVD events from 50 countries in 6 continents', '31,544 patients with vascular disease in 2 multinational prospective studies']",['ONTARGET (Ongoing Telmisartan Alone and in Combination with Ramipril Global End Point Trial) and TRANSCEND (Telmisartan'],"['blood lipids, composite outcome', 'egg intake and blood lipids, mortality, or major CVD events', 'total mortality', 'Egg consumption', 'egg consumption with blood lipids, cardiovascular disease (CVD), and mortality']","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0556195', 'cui_str': 'Egg intake'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",146011.0,0.528705,"Similar results were observed in ONTARGET/TRANSCEND studies for composite outcome (HR 0.97; 95% CI: 0.76, 1.25; P-trend = 0.09), total mortality (HR: 0.88; 95% CI: 0.62, 1.24; P-trend = 0.55), and major CVD (HR: 0.97; 95% CI: 0.73, 1.29; P-trend = 0.12).
","[{'ForeName': 'Mahshid', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mente', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sumathy', 'Initials': 'S', 'LastName': 'Rangarajan', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Mohan', 'Affiliation': ""Dr. Mohan's Diabetes Specialities Centre, Gopalapuram, Chennai, India.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Lear', 'Affiliation': 'Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Sumathi', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': ""Division of Nutrition, St John's Research Institute, Koramangala, Bangalore, India.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wielgosz', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Seron', 'Affiliation': 'Faculty of Medicine, University of La Frontera, Temuco, Chile.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'FOSCAL, Medical School, University of Santander, Bucaramanga, Colombia.'}, {'ForeName': 'Ginette', 'Initials': 'G', 'LastName': 'Turbide', 'Affiliation': 'Heart and Lung Institute, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Jephat', 'Initials': 'J', 'LastName': 'Chifamba', 'Affiliation': 'University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Khalid F', 'Initials': 'KF', 'LastName': 'AlHabib', 'Affiliation': 'Department of Cardiac Sciences, King Fahad Cardiac Center, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Mohammadifard', 'Affiliation': 'Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Szuba', 'Affiliation': 'Division of Angiology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Khatib', 'Affiliation': 'Institute for Community and Public Health, Birzeit University, Birzeit, Palestine.'}, {'ForeName': 'Yuksel', 'Initials': 'Y', 'LastName': 'Altuntas', 'Affiliation': 'Clinic of Endocrinology and Metabolism Sisli, Istanbul Sisli Hamidiye Etfal Health Training and Research Hospital, Faculty of Medicine, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Romaina', 'Initials': 'R', 'LastName': 'Iqbal', 'Affiliation': 'Department of Community Health Sciences and Medicine, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Rosengren', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, and Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Yusuf', 'Affiliation': 'School of Life Sciences, Independent University, Dhaka, Bangladesh.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Smuts', 'Affiliation': 'Centre of Excellence\xa0for Nutrition, North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'AfzalHussein', 'Initials': 'A', 'LastName': 'Yusufali', 'Affiliation': 'Hatta Hospital, Dubai Medical University, Dubai Health Authority, Dubai, UAE.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Qingshan Lake Community Health Service Center, Nanchang City, China.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Clinical Studies Latin America, Rosario, Santa Fe, Argentina.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Yusoff', 'Affiliation': 'Department of Medicine, Universiti Teknologi MARA, Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Manmeet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, School of Public Health, Chandigarh, India.'}, {'ForeName': 'Biju', 'Initials': 'B', 'LastName': 'Soman', 'Affiliation': 'Health Action by People, Thiruvananthapuram, India.'}, {'ForeName': 'Noorhassim', 'Initials': 'N', 'LastName': 'Ismail', 'Affiliation': 'Department of Community Health, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Eternal Heart Care Centre & Research Institute, Jaipur, India.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dans', 'Affiliation': 'Department of Medicine, University of the Philippines, Manila, Philippines.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sheridan', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Koon', 'Initials': 'K', 'LastName': 'Teo', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sonia S', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz348']
2953,31822377,Feasibility of a self-management intervention in adolescents with headache (SMI-AH).,"PURPOSE


This study assessed the acceptability and limited efficacy of a self-management intervention to improve lifestyle behaviors and headache outcomes among rural adolescents with recurrent headache.
DESIGN AND METHODS


Participants were randomly assigned to a self-management intervention for adolescent headache (SMI-AH, n = 13) or standard care group (n = 17). The SMI-AH group participated in goal-setting, self-monitoring, and information processing to modify lifestyle behaviors (missed meals, caffeine intake, and poor sleep). Independent samples t-test was used to compare the means of outcomes at baseline and 6-week follow-up between the treatment group and control group. Linear mixed model (LMM) was used to examine the intervention effects over time.
RESULTS


The mean age was 14.8 years (sd = 1.6, range, 12-17); with female participants accounting for 80% of the sample (n = 24) and persons reporting white race were 97% (n = 29). The SMI-AH group demonstrated a greater magnitude of change in lifestyle behaviors, including increased days of eating breakfast and lunch. The multivariate LMM showed significant intervention effect of lunch intake (p = 0.042 with Cohen's d = 0.42) and borderline significant effect of breakfast intake (p = 0.064 with Cohen's d = 0.38). Participants reported the intervention was easy to use and helpful to monitor behaviors.
CONCLUSIONS


Among rural adolescents, a self-management intervention is a feasible approach for engaging youth. The SMI-AH provides an opportunity for the adolescents to talk about their behaviors and participate in goal setting as well as the plan of care with the provider. Challenges identified in this study are manageable and a full study is feasible with modifications.",2020,"The SMI-AH group demonstrated a greater magnitude of change in lifestyle behaviors, including increased days of eating breakfast and lunch.","['adolescents with headache (SMI-AH', 'Participants', 'rural adolescents with recurrent headache', 'The mean age was 14.8\xa0years (sd\xa0=\xa01.6, range, 12-17); with female participants accounting for 80% of the sample (n\xa0=\xa024) and persons reporting white race were 97% ', 'rural adolescents']","['self-management intervention for adolescent headache (SMI-AH, n\xa0=\xa013) or standard care group', 'self-management intervention']","['lifestyle behaviors and headache outcomes', 'lunch intake', 'days of eating breakfast and lunch', 'lifestyle behaviors', 'breakfast intake']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0239888', 'cui_str': 'Headache recurrent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]",,0.0316817,"The SMI-AH group demonstrated a greater magnitude of change in lifestyle behaviors, including increased days of eating breakfast and lunch.","[{'ForeName': 'Suzy Mascaro', 'Initials': 'SM', 'LastName': 'Walter', 'Affiliation': 'Department of Family and Community Health, West Virginia University School of Nursing, Morgantown, WV 26506, United States of America. Electronic address: swalters@hsc.wvu.edu.'}, {'ForeName': 'R David', 'Initials': 'RD', 'LastName': 'Parker', 'Affiliation': 'Adelphi University College of Nursing and Public Health, Garden City, NY 11530, United States of America. Electronic address: rdparker@adelphi.edu.'}, {'ForeName': 'Kesheng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Family and Community Health, West Virginia University School of Nursing, Morgantown, WV 26506, United States of America. Electronic address: kesheng.wang@hsc.wvu.edu.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Dai', 'Affiliation': 'West Virginia University School of Public Health, Morgantown, WV 26506, United States of America. Electronic address: Zheng.Dai@hsc.wvu.edu.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Starcher', 'Affiliation': 'West Virginia University School of Public Health, Morgantown, WV 26506, United States of America. Electronic address: mrstarcher@hsc.wvu.edu.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2019.151223']
2954,31830798,Patients With Advanced Cancer Choose Less Aggressive Medical Treatment on Vignettes After Using a Computer-Based Decision Aid.,"BACKGROUND


Although patients often prefer less rather than more treatment at the end of life, in the absence of contrary instructions, the medical profession's de facto position is to treat aggressively. It is unknown whether a computer-based decision aid can affect treatment choices.
METHODS


Secondary analysis of a single-center, single-blind randomized controlled trial of an advance care planning (ACP) intervention among 200 patients with stage IV cancer. Participants were randomized to intervention ( Making Your Wishes Known , a values-neutral, educational, computer-based decision aid) or control (standard living will + brochure). After reading a hypothetical clinical vignette, participants were asked whether they would want 11 medical/surgical treatments in that situation (dialysis, cardiopulmonary resuscitation [CPR], ventilator, feeding tube, etc). The median number of treatments wanted by participants was compared between groups, and logistic regression was used to compare between-group likelihood of not wanting each specific treatment.
RESULTS


The median number of treatments wanted was 1 in the intervention group versus 5 in the control ( P  < .001). For 6 of 11 treatments, the intervention group was significantly less likely than control to want aggressive treatment. Most notably, compared to control, intervention participants were less likely to want CPR (odds ratio [OR] = 0.31), short-term mechanical ventilation (OR = 0.34), short-term dialysis (OR = 0.38), surgery (OR = 0.37), and transfusion (OR = 0.21).
CONCLUSIONS


Individuals using an educational ACP decision aid were less likely to want aggressive medical treatment than those completing standard living wills. These findings have implications not only for how to respect patient's wishes but also potentially for reducing costs at the end of life.",2020,The median number of treatments wanted was 1 in the intervention group versus 5 in the control ( P  < .001).,"['200 patients with stage IV cancer', 'Patients With Advanced Cancer Choose Less Aggressive Medical Treatment on Vignettes']","['advance care planning (ACP) intervention', 'intervention ( Making Your Wishes Known , a values-neutral, educational, computer-based decision aid) or control (standard living will + brochure']","['short-term dialysis', 'median number of treatments', 'short-term mechanical ventilation']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023914', 'cui_str': 'Living Wills'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",200.0,0.0523766,The median number of treatments wanted was 1 in the intervention group versus 5 in the control ( P  < .001).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Green', 'Affiliation': 'Department of Medicine, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Van Scoy', 'Affiliation': 'Department of Medicine, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Foy', 'Affiliation': 'Department of Medicine, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Anne E F', 'Initials': 'AEF', 'LastName': 'Dimmock', 'Affiliation': 'Department of Medicine, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lehman', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Levi', 'Affiliation': 'Department of Humanities, Penn State College of Medicine, Hershey, PA, USA.'}]",The American journal of hospice & palliative care,['10.1177/1049909119892596']
2955,31521646,The Smoker's Paradox Revisited: A Patient-Level Pooled Analysis of 18 Randomized Controlled Trials.,"OBJECTIVES


This study examined the smoker's paradox using patient-level data from 18 prospective, randomized trials of patients undergoing percutaneous coronary intervention (PCI) with stent implantation.
BACKGROUND


Studies on the effects of smoking and outcomes among patients undergoing PCI have reported conflicting results.
METHODS


Data from the RAVEL, E-SIRIUS, SIRIUS, C-SIRIUS, TAXUS IV and V, ENDEAVOR II to IV, SPIRIT II to IV, HORIZONS-AMI, COMPARE I and II, PLATINUM, and TWENTE I and II randomized trials were pooled. Patients were stratified by smoking status at time of enrollment. The 1- and 5-year ischemic outcomes were compared.
RESULTS


Among 24,354 patients with available data on smoking status, 6,722 (27.6%) were current smokers. Smokers were younger and less likely to have diabetes mellitus; hypertension; hyperlipidemia; or prior myocardial infarction (MI), PCI, or coronary artery bypass grafting. Angiographically, smokers had longer lesions, more complex lesions, and more occlusions, but were less likely to have moderate or severe calcification or tortuosity. At 5 years, smokers had significantly higher rates of MI (7.8% vs. 5.6%; p < 0.0001) and definite or probable stent thrombosis (3.5% vs. 1.8%; p < 0.0001); however, there were no differences in the rates of death, cardiac death, target lesion revascularization, or composite endpoints (cardiac death, target vessel MI, or ischemic target lesion revascularization). After multivariable adjustment for potential confounders, smoking was a strong independent predictor of death (hazard ratio [HR]: 1.86; 95% confidence interval [CI]: 1.63 to 2.12; p < 0.0001), cardiac death (HR: 1.68; 95% CI: 1.38 to 2.05; p < 0.0001), MI (HR: 1.38; 95% CI: 1.20 to 1.58; p < 0.0001), stent thrombosis (HR: 1.60; 95% CI: 1.28 to 1.99; p < 0.0001), and target lesion failure (HR: 1.17; 95% CI: 1.05 to 1.30; p = 0.005).
CONCLUSIONS


The present large, patient-level, pooled analysis with 5-year follow-up clearly demonstrates smoking to be an important predictor of adverse outcomes after PCI.",2019,"At 5 years, smokers had significantly higher rates of MI (7.8% vs. 5.6%; p < 0.0001) and definite or probable stent thrombosis (3.5% vs. 1.8%; p < 0.0001); however, there were no differences in the rates of death, cardiac death, target lesion revascularization, or composite endpoints (cardiac death, target vessel MI, or ischemic target lesion revascularization).","[""Smoker's Paradox Revisited"", 'patients undergoing PCI', '24,354 patients with available data on smoking status, 6,722 (27.6%) were current smokers', 'Smokers were younger and less likely to have diabetes mellitus; hypertension; hyperlipidemia; or prior myocardial infarction (MI), PCI, or coronary artery bypass grafting', 'patients undergoing']",['percutaneous coronary intervention (PCI'],"['target lesion failure', 'cardiac death', 'One- and 5-year ischemic outcomes', 'rates of MI', 'stent thrombosis', 'definite or probable stent thrombosis', 'rates of death, cardiac death, target lesion revascularization, or composite endpoints (cardiac death, target vessel MI, or ischemic target lesion revascularization']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3241966'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}]",,0.27658,"At 5 years, smokers had significantly higher rates of MI (7.8% vs. 5.6%; p < 0.0001) and definite or probable stent thrombosis (3.5% vs. 1.8%; p < 0.0001); however, there were no differences in the rates of death, cardiac death, target lesion revascularization, or composite endpoints (cardiac death, target vessel MI, or ischemic target lesion revascularization).","[{'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Yadav', 'Affiliation': 'Department of Medicine, Division of Cardiology, Bronx Lebanon Hospital Center, New York, New York.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Mintz', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Généreux', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey; Hôpital du Sacré-Coeur de Montréal, Montréal, Canada.'}, {'ForeName': 'Mengdan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McAndrew', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': 'Department of Medicine, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. Electronic address: gs2184@columbia.edu.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.06.034']
2956,31857652,The effect of exercise on intramyocellular acetylcarnitine (AcCtn) concentration in adult growth hormone deficiency (GHD).,"To cover increasing energy demands during exercise, tricarboxylic cycle (TCA) flux in skeletal muscle is markedly increased, resulting in the increased formation of intramyocellular acetylcarnitine (AcCtn). We hypothesized that reduced substrate availability within the exercising muscle, reflected by a diminished increase of intramyocellular AcCtn concentration during exercise, might be an underlying mechanism for the impaired exercise performance observed in adult patients with growth hormone deficiency (GHD). We aimed at assessing the effect of 2 hours of moderately intense exercise on intramyocellular AcCtn concentrations, measured by proton magnetic resonance spectroscopy ( 1 H-MRS), in seven adults with GHD compared to seven matched control subjects (CS). Compared to baseline levels AcCtn concentrations significantly increased after 2 hours of exercise, and significantly decreased over the following 24 hours (ANOVA p for effect of time = 0.0023 for all study participants; p = 0.067 for GHD only, p = 0.045 for CS only). AcCtn concentrations at baseline, as well as changes in AcCtn concentrations over time were similar between GHD patients and CS (ANOVA p for group effect = 0.45). There was no interaction between group and time (p = 0.53). Our study suggests that during moderately intense exercise the availability of energy substrate within the exercising muscle is not significantly different in GHD patients compared to CS.",2019,"AcCtn concentrations at baseline, as well as changes in AcCtn concentrations over time were similar between GHD patients and CS (ANOVA p for group effect = 0.45).","['adult growth hormone deficiency (GHD', 'adult patients with growth hormone deficiency (GHD', 'seven adults with GHD compared to seven matched control subjects (CS']",['exercise'],"['AcCtn concentrations', 'intramyocellular AcCtn concentrations', 'intramyocellular acetylcarnitine (AcCtn) concentration', 'intramyocellular AcCtn concentration']","[{'cui': 'C1720505', 'cui_str': 'Adult growth hormone deficiency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency (disorder)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}]",7.0,0.0685954,"AcCtn concentrations at baseline, as well as changes in AcCtn concentrations over time were similar between GHD patients and CS (ANOVA p for group effect = 0.45).","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Meienberg', 'Affiliation': 'Endocrinology & Diabetology, Kantonsspital Baselland, Liestal, Switzerland.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Loher', 'Affiliation': 'Innere Medizin, Kantonsspital, St. Gallen, Switzerland.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bucher', 'Affiliation': 'EndoDia Praxis, Biel, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Jenni', 'Affiliation': 'Praxis Endokrinologie Diabetologie Bern, Bern, Switzerland.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Krüsi', 'Affiliation': 'Praxis Endokrinologie & Diabetologie, Zürich Unterland, Embrach, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Kreis', 'Affiliation': 'Departments of Biomedical Research and Radiology, University Bern, Bern, Switzerland.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Boesch', 'Affiliation': 'Departments of Biomedical Research and Radiology, University Bern, Bern, Switzerland.'}, {'ForeName': 'Matthias Johannes', 'Initials': 'MJ', 'LastName': 'Betz', 'Affiliation': 'Endocrinology, Diabetes & Metabolism, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Christ', 'Affiliation': 'Endocrinology, Diabetes & Metabolism, University Hospital Basel and University of Basel, Basel, Switzerland. Emanuel.Christ@usb.ch.'}]",Scientific reports,['10.1038/s41598-019-55942-w']
2957,31445343,Bipolar depression and suicidal ideation: Moderators and mediators of a complex relationship.,"INTRODUCTION


Not all patients with bipolar depression have suicidal ideation (SI). This study examines some factors that link bipolar depression to SI.
METHODS


482 individuals with bipolar I or II were randomized to either lithium or quetiapine plus adjunctive personalized therapy in a 24 week comparative effectiveness trial. Severity of depression and SI were assessed with the Bipolar Inventory of Symptoms Scale (BISS). We examined potential moderators (age, gender, age of illness onset, bipolar type, comorbid anxiety, substance use, past suicide attempts, childhood abuse and treatment arm) and mediators (severity of anxiety, mania, irritability, impairment in functioning (LIFE-RIFT) and satisfaction and enjoyment of life (Q-LES-Q)) of the effect of depression on SI. Statistical analyses were conducted using generalized estimating equations with repeated measures.
RESULTS


Bipolar type and past suicide attempts moderated the effect of depression on SI. Life satisfaction mediated the effect of depression and SI. The relationship between anxiety, depression and SI was complex due to the high level of correlation. Treatment with lithium or quetiapine did not moderate the effect of depression on SI.
LIMITATIONS


Suicide assessment was only done using an item on BISS. Patient population was not specifically chosen for high suicide risk.
DISCUSSION


Individuals with Bipolar II experienced more SI with lower levels of depression severity. A history of suicide predisposed patients to higher levels of SI given the same severity of depression. Reduced life satisfaction mediates the effect of depression on SI and may be a target for therapeutic interventions.",2019,"Treatment with lithium or quetiapine did not moderate the effect of depression on SI.
","['patients with bipolar depression have suicidal ideation (SI', '482 individuals with bipolar I or II']","['lithium or quetiapine plus adjunctive personalized therapy', 'lithium or quetiapine']","['mediators (severity of anxiety, mania, irritability, impairment in functioning (LIFE-RIFT) and satisfaction and enjoyment of life (Q-LES-Q', 'Bipolar Inventory of Symptoms Scale (BISS', 'depression on SI', 'Severity of depression and SI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}]","[{'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0424131', 'cui_str': 'Enjoyment of life (observable entity)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",482.0,0.0495685,"Treatment with lithium or quetiapine did not moderate the effect of depression on SI.
","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Kamali', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States; Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States. Electronic address: mkamali@mgh.harvard.edu.'}, {'ForeName': 'Noreen A', 'Initials': 'NA', 'LastName': 'Reilly-Harrington', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Weilynn C', 'Initials': 'WC', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati OH and Lindner Center of HOPE, Mason, OH, United States.'}, {'ForeName': 'Terence A', 'Initials': 'TA', 'LastName': 'Ketter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Science Center, Albuquerque, NM, United States.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kocsis', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, New York, NY, United States.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University, Cleveland, OH, United States.'}, {'ForeName': 'Keming', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University, Cleveland, OH, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Bowden', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, United States.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Kinrys', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Bobo', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Brody', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, New York, NY, United States.'}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Dustin J', 'Initials': 'DJ', 'LastName': 'Rabideau', 'Affiliation': 'Department of Biostatistics, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2019.08.032']
2958,32438990,Prognostic Value of SYNTAX Score in Patients With Infarct-Related Cardiogenic Shock: Insights From the CULPRIT-SHOCK Trial.,"OBJECTIVES


This study sought to evaluate the prognostic value of the SYNTAX (SYNergy between PCI with TAXUS and Cardiac Surgery) scores in patients undergoing percutaneous coronary intervention (PCI) for multivessel coronary disease with infarct-related cardiogenic shock (CS).
BACKGROUND


The prognostic value of the SYNTAX score in this high-risk setting remains unclear.
METHODS


The CULPRIT-SHOCK (Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock) trial was an international, open-label trial, where patients presenting with infarct-related CS and multivessel disease were randomized to a culprit-lesion-only or an immediate multivessel PCI strategy. Baseline SYNTAX score was assessed by a central core laboratory and categorized as low SYNTAX score (SS ≤22), intermediate SYNTAX score (22<SS≤32) and high SYNTAX score (SS>32). Adjudicated endpoints of interest were the 30-day risk of death or renal replacement therapy (RRT) and 1-year death. Associations between baseline SYNTAX score and outcomes were assessed using multivariate logistic regression.
RESULTS


Pre-PCI SYNTAX score was available in 624 patients, of whom 263 (42.1%), 207 (33.2%) and 154 (24.7%) presented with low, intermediate and high SYNTAX score, respectively. A stepwise increase in the incidence of adverse events was observed from low to intermediate and high SYNTAX score for the 30-day risk of death or RRT and the 1-year risk of death (p < 0.001, for all). After multiple adjustments, intermediate and high SYNTAX score remained strongly associated with 30-day risk of death or renal replacement therapy and 1-year risk of all-cause death. There was no significant interaction between SYNTAX score and the coronary revascularization strategy for any outcomes.
CONCLUSIONS


In patients presenting with multivessel disease and infarct-related CS, the SYNTAX score was strongly associated with 30-day death or RRT and 1-year mortality.",2020,"After multiple adjustments, intermediate and high SYNTAX score remained strongly associated with 30-day risk of death or renal replacement therapy and 1-year risk of all-cause death.","['patients presenting with infarct-related CS and multivessel disease', 'Patients', 'patients undergoing percutaneous coronary intervention (PCI) for multivessel coronary disease with infarct-related cardiogenic shock (CS']",['SYNTAX'],"['30-day risk of death or renal replacement therapy (RRT) and 1-year death', '30-day death or RRT and 1-year mortality', 'Baseline SYNTAX score', '30-day risk of death or RRT and the 1-year risk of death', 'low SYNTAX score (SS\xa0≤22), intermediate SYNTAX score (22<SS≤32) and high SYNTAX score (SS>32', '30-day risk of death or renal replacement therapy and 1-year risk of all-cause death', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.1222,"After multiple adjustments, intermediate and high SYNTAX score remained strongly associated with 30-day risk of death or renal replacement therapy and 1-year risk of all-cause death.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Barthélémy', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Zeitouni', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Hage', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Kerneis', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Overtchouk', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Rouanet', 'Affiliation': 'ACTION Study Group, Statistician Unit, StatEthic, Levallois-Perret, France.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'University Heart Center Lübeck, Lübeck, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'University Heart Center Lübeck, Lübeck, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Klinikum Ludwigshafen, Institut fur Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Heart Center Leipzig, Leipzig Heart Institute, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': 'First Department of Medicine-Cardiology, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig, Leipzig Heart Institute, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig, Leipzig Heart Institute, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.04.003']
2959,31441430,Comparing Characteristics of Patients Who Connect Their iPhones to an Electronic Health Records System Versus Patients Who Connect Without Personal Devices: Cohort Study.,"BACKGROUND


While individual access to health records has traditionally been through paper and other physical media, there has been a recent push toward digitizing this process. Direct patient access to health data through application programming interfaces (APIs) is an important part of current United States policy initiatives, and Apple has created the product ""Health Records on iPhone"" to leverage APIs for this purpose.
OBJECTIVE


The objective of this study was to examine the characteristics of patients at our institution who connected their personal iPhone devices to our electronic health records (EHRs) system through ""Health Records on iPhone"", as compared to patients at our institution who used our patient portal but did not connect a personal device to our system.
METHODS


We examined adult patients at our institution who had authorized an iPhone device to download their health data from the Partners HealthCare EHR via APIs through ""Health Records on iPhone"" from February 18, 2018 (the date this feature was enabled at our health system) until February 17, 2019. We compared these patients to adult patients who used our portal at least once during this period but did not authorize an iPhone device to download their data via APIs.
RESULTS


Variables associated with an increased likelihood of using ""Health Records on iPhone"" included male gender (adjusted OR 3.36; 95% CI 3.11-3.62; P<.001) and younger age, particularly below 50 years of age. With each decade of age over 50, people were less likely to be ""Health Records on iPhone"" product users. Asian patients were more likely to use the product than Caucasian patients (adjusted OR 1.32; 95% CI 1.16-1.51; P<.001), though there was no significant difference between African Americans and Caucasians (adjusted OR 1.15; 95% CI 0.94-1.41; P=.17). Patients who resided in higher ZIP code income quartiles were more likely to be users than those in the lowest quartile.
CONCLUSIONS


Early results from the implementation of patient-facing APIs at a single institution suggest that there are opportunities for expanding these technologies to ensure all patients are aware of, and have access to, their health data on their personal devices. More work is needed on expanding these technologies to different patient populations.",2019,"Asian patients were more likely to use the product than Caucasian patients (adjusted OR 1.32; 95% CI 1.16-1.51; P<.001), though there was no significant difference between African Americans and Caucasians (adjusted OR 1.15; 95% CI 0.94-1.41; P=.17).","['adult patients at our institution who had authorized an iPhone device to download their health data from the Partners HealthCare EHR via APIs through ""Health Records on iPhone"" from February 18, 2018 (the date this feature was enabled at our health system) until February 17, 2019', 'patients to adult patients who used our portal at least once during this period but did not authorize an iPhone device to download their data via APIs', 'patients at our institution who connected their personal iPhone devices to our electronic health records (EHRs) system through ""Health Records on iPhone"", as compared to patients at our institution who used our patient portal but did not connect a personal device to our system']",[],"['likelihood of using ""Health']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4277550', 'cui_str': 'Patient Portal'}]",[],"[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0547629,"Asian patients were more likely to use the product than Caucasian patients (adjusted OR 1.32; 95% CI 1.16-1.51; P<.001), though there was no significant difference between African Americans and Caucasians (adjusted OR 1.15; 95% CI 0.94-1.41; P=.17).","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Gordon', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': 'Partners HealthCare, Somerville, MA, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pappas', 'Affiliation': 'Partners HealthCare, Somerville, MA, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Silacci', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Landman', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}]",Journal of medical Internet research,['10.2196/14871']
2960,31645430,Maternal Humoral Immune Responses Do Not Predict Postnatal HIV-1 Transmission Risk in Antiretroviral-Treated Mothers from the IMPAACT PROMISE Study.,"To design immune interventions that can synergize with antiretroviral therapy (ART) to reduce the rate of HIV mother-to-child transmission (MTCT), it is essential to characterize maternal immune responses in the setting of ART during pregnancy and breastfeeding and define their effect on MTCT. Prior studies reported an association between breast milk envelope (Env)-specific antibodies and antibody-dependent cell cytotoxicity (ADCC) activity with reduced postnatal transmission. In this study, we investigated whether these immune correlates were similarly associated with protection in a matched case-control study of mother-infant pairs receiving maternal ART or infant nevirapine prophylaxis during breastfeeding in the International Maternal-Pediatric-Adolescent AIDS Clinical Trials Network Promoting Maternal-Infant Survival Everywhere (PROMISE) trial, assessing postnatal transmission risk in 19 transmitting and 57 nontransmitting mothers using conditional logistic regression models adjusted for maternal plasma viral load. The odds ratios of postnatal MTCT for a 1-unit increase in an immune correlate were 3.61 (95% confidence interval [CI], 0.56, 23.14) for breast milk Env-specific secretory IgA (sIgA), 2.32 (95% CI, 0.43, 12.56) for breast milk and 2.16 (95% CI, 0.51, 9.14) for plasma Env-specific IgA, and 4.57 (95% CI, 0.68, 30.48) for breast milk and 0.96 (95% CI, 0.25, 3.67) for plasma ADCC activity, with all CIs spanning 1.0. Interestingly, although mucosal IgA responses are poor in untreated HIV-infected women, there was a strong correlation between the magnitudes of breast milk and plasma Env-specific IgA in this cohort. In this analysis of the small number of postnatal virus transmissions in the landmark PROMISE study, no single antibody response was associated with breast milk transmission risk. IMPORTANCE  Each year, >150,000 infants become newly infected with HIV-1 through MTCT despite ART, with up to 42% of infections occurring during breastfeeding. Several factors contribute to continued pediatric infections, including ART nonadherence, the emergence of drug-resistant HIV strains, acute infection during breastfeeding, and poor access to ART in resource-limited areas. A better understanding of the maternal humoral immune responses that provide protection against postnatal transmission in the setting of ART is critical to guide the design of maternal vaccine strategies to further eliminate postnatal HIV transmission. In this study, we found that in women treated with antiretrovirals during pregnancy, there was a positive correlation between plasma viral load and breast milk and plasma IgA responses; however, conclusions regarding odds of MTCT risk were limited by the small sample size. These findings will inform future studies to investigate maternal immune interventions that can synergize with ART to eliminate MTCT during breastfeeding.",2019,"The odds ratios of postnatal MTCT for a 1-unit increase in an immune correlate were 3.61 (95% confidence interval [CI], 0.56, 23.14) for breast milk Env-specific secretory IgA (sIgA), 2.32 (95% CI, 0.43, 12.56) for breast milk and 2.16 (95% CI, 0.51, 9.14) for plasma Env-specific IgA, and 4.57 (95% CI, 0.68, 30.48) for breast milk and 0.96 (95% CI, 0.25, 3.67) for plasma ADCC activity, with all CIs spanning 1.0.","['150,000 infants become newly infected with HIV-1 through MTCT despite ART, with up to 42% of infections occurring during breastfeeding', '19 transmitting and 57 nontransmitting mothers']","['mother-infant pairs receiving maternal ART or infant nevirapine prophylaxis', 'antiretroviral therapy (ART']","['Maternal Humoral Immune Responses', 'plasma ADCC activity', 'cell cytotoxicity (ADCC) activity', 'mucosal IgA responses', 'plasma viral load and breast milk and plasma IgA responses', 'Maternal-Infant Survival', 'Transmission Risk', 'odds ratios of postnatal MTCT']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003272', 'cui_str': 'Antibody-dependent cellular cytotoxicity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}]",150000.0,0.125915,"The odds ratios of postnatal MTCT for a 1-unit increase in an immune correlate were 3.61 (95% confidence interval [CI], 0.56, 23.14) for breast milk Env-specific secretory IgA (sIgA), 2.32 (95% CI, 0.43, 12.56) for breast milk and 2.16 (95% CI, 0.51, 9.14) for plasma Env-specific IgA, and 4.57 (95% CI, 0.68, 30.48) for breast milk and 0.96 (95% CI, 0.25, 3.67) for plasma ADCC activity, with all CIs spanning 1.0.","[{'ForeName': 'Eliza D', 'Initials': 'ED', 'LastName': 'Hompe', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Denise L', 'Initials': 'DL', 'LastName': 'Jacobson', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Eudailey', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Butler', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Edwards', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Pollara', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Sean S', 'Initials': 'SS', 'LastName': 'Brummel', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Genevieve G', 'Initials': 'GG', 'LastName': 'Fouda', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Lameck', 'Initials': 'L', 'LastName': 'Chinula', 'Affiliation': 'University of North Carolina Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Kamanga', 'Affiliation': 'Johns Hopkins University Research Project, Blantyre, Malawi.'}, {'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Kinikar', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa and School of Clinical Medicine, College of Health Sciences, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Maxensia', 'Initials': 'M', 'LastName': 'Owor', 'Affiliation': 'Johns Hopkins University Research Collaboration, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Sallie R', 'Initials': 'SR', 'LastName': 'Permar', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA sallie.permar@duke.edu.'}]",mSphere,['10.1128/mSphere.00716-19']
2961,31809418,Early Radiographic Union Score for Hip Is Predictive of Femoral Neck Fracture Complications Within 2 Years.,"OBJECTIVES


To determine if the Radiographic Union Score for Hip (RUSH) measured at 3 and 6 months after femoral neck fracture were predictive of reoperation for infection, nonunion, delayed union, avascular necrosis, or implant failure within 24 months of initial surgery.
DESIGN


Secondary analysis of a randomized controlled trial. Logistic regression was performed to investigate associations between lower RUSH and reoperation. Results were reported as odds ratios (OR), 95% confidence intervals (CIs), and associated P values. All tests were 2 tailed with alpha = 0.05.
SETTING


Eighty-one clinical sites across 8 countries.
PATIENTS/PARTICIPANTS


Data from 734 of the clinical trial participants with radiographs at 3 and 6 months after fracture fixation were included.
INTERVENTION


A reviewer blinded to patients' outcomes independently assigned a RUSH at each follow-up time point.
MAIN OUTCOME MEASURES


Revision surgery rate related to intervention.
RESULTS


Lower RUSH at 3 and 6 months were associated with increased odds of reoperation within 24 months of fracture fixation. For every 2-point decrease in RUSH at 3 months, there was a 16% increase in the odds of a patient experiencing a re-operation (OR, 1.16; 95% CI, 1.10-1.22; P < 0.0001). A similar association was observed at the 6-month assessment for every 2-point decrease (OR = 1.05; 95% CI, 1.01-1.09; P = 0.005).
CONCLUSIONS


Decreased radiographic healing as early as 3 months post fracture fixation is associated with developing patient important femoral neck fracture reoperations. This relationship may guide early treatment decisions, suggesting that 3- and 6-month RUSH are a useful surrogate measure of reoperations within 24 months of fracture fixation.
LEVEL OF EVIDENCE


Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"RESULTS


Lower RUSH at 3 and 6 months were associated with increased odds of reoperation within 24 months of fracture fixation.","['Eighty-one clinical sites across 8 countries', 'Data from 734 of the clinical trial participants with radiographs at 3 and 6 months after fracture fixation were included']",[],"['Radiographic Union Score for Hip (RUSH', 'odds of reoperation', 'Revision surgery rate related to intervention', 'RUSH', 'radiographic healing', 'reoperation for infection, nonunion, delayed union, avascular necrosis, or implant failure']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016641', 'cui_str': 'Fixation of fracture'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0027543', 'cui_str': 'Avascular necrosis of bone'}, {'cui': 'C0854676', 'cui_str': 'Failure of implant'}]",2.0,0.130555,"RESULTS


Lower RUSH at 3 and 6 months were associated with increased odds of reoperation within 24 months of fracture fixation.","[{'ForeName': 'Martí', 'Initials': 'M', 'LastName': 'Bernaus', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital Universitari Mútua Terrassa, Barcelona, Spain.'}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bzovsky', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Swiontkowski', 'Affiliation': 'Department of Orthopaedic Surgery, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001713']
2962,31831270,The effect of acupressure on quality of life among female nurses with chronic back pain.,"BACKGROUND


Chronic back pain is one of the most common work-related diseases and most important of musculoskeletal disorders in nursing professionals and because of the physical and psychological effects, has a significant impact on quality of life (QOL). Acupressure is a holistic form of complementary medicine. This study aimed to investigate the effect of acupressure on QOL among female nurses with chronic back pain.
MATERIALS AND METHODS


This randomized single-blind clinical trial was conducted on 50 nurses with chronic back pain working at the selected hospitals in Isfahan, Iran. After convenient sampling, the subjects were randomly allocated, through lottery, to the two groups of experimental (n = 25) and sham (n = 25). In the experimental group, acupressure techniques were performed during 9 sessions, 3 times a week for 14 min for each patient. In the sham group, points within 1 cm of the main points were only touched. Data were collected using the SF36 questioner, before, and immediately, 2 weeks, and 4 weeks after the intervention. Data analysis was performed using SPSS software.
RESULTS


Independent t-test showed that the mean total score of QOL before the intervention was not significantly different between the two groups before the intervention (P = .68). However, it was significantly higher in the experimental group compared to the Sham group, immediately, 2 weeks, and 1 month after the intervention (P < .001).
CONCLUSIONS


Acupressure on specific points of the foot and back improves back pain and as a result, increases QOL. Therefore, acupressure can be used as a drug-free and low-cost approach without side effects to improve QOL in nurses with chronic back pain.",2020,"RESULTS


Independent t-test showed that the mean total score of QOL before the intervention was not significantly different between the two groups before the intervention (P = .68).","['50 nurses with chronic back pain working at the selected hospitals in Isfahan, Iran', 'nurses with chronic back pain', 'female nurses with chronic back pain']","['Acupressure', 'acupressure']","['quality of life', 'QOL', 'back pain', 'quality of life (QOL', 'mean total score of QOL']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.067822,"RESULTS


Independent t-test showed that the mean total score of QOL before the intervention was not significantly different between the two groups before the intervention (P = .68).","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Movahedi Najafabadi', 'Affiliation': 'Nursing group, Faculty of Paramedical Sciences,Islamic azad university, Aligudarz branch, Lorestan, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Ghafari', 'Affiliation': 'Nursing and Midwifery care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nazari', 'Affiliation': 'Adult Health Nursing Dept., Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Valiani', 'Affiliation': 'Nursing and Midwifery care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2019.05.020']
2963,32060497,"Glycolysis/gluconeogenesis- and tricarboxylic acid cycle-related metabolites, Mediterranean diet, and type 2 diabetes.","BACKGROUND


Glycolysis/gluconeogenesis and tricarboxylic acid (TCA) cycle metabolites have been associated with type 2 diabetes (T2D). However, the associations of these metabolites with T2D incidence and the potential effect of dietary interventions remain unclear.
OBJECTIVES


We aimed to evaluate the association of baseline and 1-y changes in glycolysis/gluconeogenesis and TCA cycle metabolites with insulin resistance and T2D incidence, and the potential modifying effect of Mediterranean diet (MedDiet) interventions.
METHODS


We included 251 incident T2D cases and 638 noncases in a nested case-cohort study within the PREDIMED Study during median follow-up of 3.8 y. Participants were allocated to MedDiet + extra-virgin olive oil, MedDiet + nuts, or control diet. Plasma metabolites were measured using a targeted approach by LC-tandem MS. We tested the associations of baseline and 1-y changes in glycolysis/gluconeogenesis and TCA cycle metabolites with subsequent T2D risk using weighted Cox regression models and adjusting for potential confounders. We designed a weighted score combining all these metabolites and applying the leave-one-out cross-validation approach.
RESULTS


Baseline circulating concentrations of hexose monophosphate, pyruvate, lactate, alanine, glycerol-3 phosphate, and isocitrate were significantly associated with higher T2D risk (17-44% higher risk for each 1-SD increment). The weighted score including all metabolites was associated with a 30% (95% CI: 1.12, 1.51) higher relative risk of T2D for each 1-SD increment. Baseline lactate and alanine were associated with baseline and 1-y changes of homeostasis model assessment of insulin resistance. One-year increases in most metabolites and in the weighted score were associated with higher relative risk of T2D after 1 y of follow-up. Lower risks were observed in the MedDiet groups than in the control group although no significant interactions were found after adjusting for multiple comparisons.
CONCLUSIONS


We identified a panel of glycolysis/gluconeogenesis-related metabolites that was significantly associated with T2D risk in a Mediterranean population at high cardiovascular disease risk. A MedDiet could counteract the detrimental effects of these metabolites.This trial was registered at controlled-trials.com as ISRCTN35739639.",2020,"Lower risks were observed in the MedDiet groups than in the control group although no significant interactions were found after adjusting for multiple comparisons.
","['251 incident T2D cases and 638 noncases in a nested case-cohort study within the PREDIMED Study during median follow-up of 3.8 y. Participants', 'Mediterranean population at high cardiovascular disease risk']","['MedDiet\xa0+\xa0extra-virgin olive oil, MedDiet\xa0+\xa0nuts, or control diet', 'gluconeogenesis and tricarboxylic acid ', 'Glycolysis/gluconeogenesis- and tricarboxylic acid cycle-related metabolites, Mediterranean diet', 'Mediterranean diet (MedDiet) interventions']","['Plasma metabolites', 'Lower risks', 'hexose monophosphate, pyruvate, lactate, alanine, glycerol-3 phosphate, and isocitrate', 'T2D risk', 'Baseline lactate and alanine', 'weighted score including all metabolites']","[{'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0017715', 'cui_str': 'Gluconeogenesis'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0017952', 'cui_str': 'Glycolysis'}, {'cui': 'C0008858', 'cui_str': 'Krebs cycle pathway'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0019494', 'cui_str': 'Hexose'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0051369', 'cui_str': 'alpha-glycerophosphoric acid'}, {'cui': 'C0022160', 'cui_str': 'Isocitrates'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",251.0,0.0569746,"Lower risks were observed in the MedDiet groups than in the control group although no significant interactions were found after adjusting for multiple comparisons.
","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Guasch-Ferré', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Santos', 'Affiliation': 'Department of Nutrition, Diabetes and Metabolism, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Martínez-González', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Clary B', 'Initials': 'CB', 'LastName': 'Clish', 'Affiliation': 'Broad Institute of MIT and Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Razquin', 'Affiliation': 'Department of Preventive Medicine and Public Health, IdiSNA (Health Research Institute of Navarra), University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Dennis', 'Affiliation': 'Broad Institute of MIT and Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Muñoz-Bravo', 'Affiliation': 'Department of Public Health and Psychiatry, University of Málaga, Málaga, Spain.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Romaguera', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Santos-Lozano', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Alonso-Gómez', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Canudas', 'Affiliation': 'Human Nutrition Unit, Faculty of Medicine and Health Sciences, Pere Virgili Health Research Institute, Rovira i Virgili University, Reus, Spain.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Asensio', 'Affiliation': 'Department of Preventive Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Pierce', 'Affiliation': 'Broad Institute of MIT and Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'Human Nutrition Unit, Faculty of Medicine and Health Sciences, Pere Virgili Health Research Institute, Rovira i Virgili University, Reus, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Toledo', 'Affiliation': 'Department of Preventive Medicine and Public Health, IdiSNA (Health Research Institute of Navarra), University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ruiz-Canela', 'Affiliation': 'Department of Preventive Medicine and Public Health, IdiSNA (Health Research Institute of Navarra), University of Navarra, Pamplona, Spain.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa016']
2964,30854916,"A Randomized, Double-Blind, Placebo-Controlled, Crossover Study Examining the Hormonal and Vitality Effects of Ashwagandha ( Withania somnifera) in Aging, Overweight Males.","Ashwagandha ( Withania somnifera) is a herb commonly used in Ayurvedic medicine to promote youthful vigor, enhance muscle strength and endurance, and improve overall health. In this 16-week, randomized, double-blind, placebo-controlled, crossover study, its effects on fatigue, vigor, and steroid hormones in aging men were investigated. Overweight men aged 40-70 years, with mild fatigue, were given a placebo or an ashwagandha extract (Shoden beads, delivering 21 mg of withanolide glycosides a day) for 8 weeks. Outcome measures included the Profile of Mood States, Short Form (POMS-SF), Aging Males' Symptoms (AMS) questionnaire, and salivary levels of DHEA-S, testosterone, cortisol, and estradiol. Fifty-seven participants were enrolled, with 50 people completing the first 8-week period of the trial and 43 completing all 16 weeks. Improvements in fatigue, vigor, and sexual and psychological well-being were reported over time, with no statistically significant between-group differences. Ashwagandha intake was associated with an 18% greater increase in DHEA-S ( p = .005) and 14.7% greater increase in testosterone ( p = .010) compared to the placebo. There were no significant between-group differences in cortisol and estradiol. In conclusion, the intake of a standardized ashwagandha extract (Shoden beads) for 8 weeks was associated with increased levels of DHEA-S and testosterone, although no significant between-group differences were found in cortisol, estradiol, fatigue, vigor, or sexual well-being. Further studies with larger sample sizes are required to substantiate the current findings.",2019,"Improvements in fatigue, vigor, and sexual and psychological well-being were reported over time, with no statistically significant between-group differences.","['aging men', 'Overweight men aged 40-70 years, with mild fatigue', 'Aging, Overweight Males', 'Fifty-seven participants were enrolled, with 50 people completing the first 8-week period of the trial and 43 completing all 16 weeks']","['Placebo', 'Ashwagandha ( Withania somnifera', 'placebo', 'placebo or an ashwagandha extract (Shoden beads, delivering 21 mg of withanolide glycosides']","['levels of DHEA-S and testosterone', 'testosterone', 'Ashwagandha intake', ""Profile of Mood States, Short Form (POMS-SF), Aging Males' Symptoms (AMS) questionnaire, and salivary levels of DHEA-S, testosterone, cortisol, and estradiol"", 'DHEA-S', 'fatigue, vigor, and steroid hormones', 'fatigue, vigor, and sexual and psychological well-being', 'cortisol and estradiol', 'cortisol, estradiol, fatigue, vigor, or sexual well-being']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C1061163', 'cui_str': 'Withania somnifera'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1955897', 'cui_str': 'Withanolides'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone (substance)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]",57.0,0.390385,"Improvements in fatigue, vigor, and sexual and psychological well-being were reported over time, with no statistically significant between-group differences.","[{'ForeName': 'Adrian L', 'Initials': 'AL', 'LastName': 'Lopresti', 'Affiliation': '1 School of Psychology and Exercise Science, Murdoch University, Perth, Western Australia, Australia.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Drummond', 'Affiliation': '1 School of Psychology and Exercise Science, Murdoch University, Perth, Western Australia, Australia.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Smith', 'Affiliation': '1 School of Psychology and Exercise Science, Murdoch University, Perth, Western Australia, Australia.'}]",American journal of men's health,['10.1177/1557988319835985']
2965,32439205,"Intraoperative application of inactivated Pseudomonas aeruginosa in patients undergoing lateral neck dissection for metastatic thyroid cancer: A randomized, parallel group, placebo-controlled trial.","BACKGROUND


We hypothesize that the intraoperative, prophylactic application of Pseudomonas aeruginosa can decrease postoperative chylous fistula and enhance recovery after surgery in patients with thyroid cancer undergoing lateral neck lymph node dissection.
METHOD


In this single-center trial, we assigned randomly 200 patients with thyroid cancer who had proven lateral lymph node metastasis to groups receiving either 2 mL Pseudomonas aeruginosa spray (Pseudomonas aeruginosa group) or 2 mL saline spray (control group) in the lateral cervical surgical field. The primary end points were the rate of chylous fistula, mean difference in the duration and volume of drainage fluid, days of postoperative hospital stay, and overall cost. The secondary end points included the red blood cell count and triglyceride level in the drainage, the white blood cell count in the blood, fever, local pain, development of a pleural effusion, and tumor recurrence.
RESULTS


Patients treated with Pseudomonas aeruginosa had a decrease in macroscopic chylous fistula compared with controls (0 vs 6%, P = .025). There were fewer days to drain-tube removal, a less volume of drainage fluid, fewer postoperative days of hospital stay, and a lesser red blood cell count in the drainage fluid in the Pseudomonas aeruginosa group than in the control group (all P < .05). No severe side effects of the Pseudomonas aeruginosa spray with respect to fever, pain, or pleural effusion were observed. Pseudomonas aeruginosa spraying did not affect postoperative recurrence of the thyroid cancer.
CONCLUSION


Intraoperative spraying of inactivated Pseudomonas aeruginosa in the lateral neck compartment can decrease the development of chylous fistula and enhance postoperative recovery.",2020,"There were fewer days to drain-tube removal, a less volume of drainage fluid, fewer postoperative days of hospital stay, and a lesser red blood cell count in the drainage fluid in the Pseudomonas aeruginosa group than in the control group (all P < .05).","['patients undergoing lateral neck dissection for metastatic thyroid cancer', 'patients with thyroid cancer undergoing lateral neck lymph node dissection', '200 patients with thyroid cancer who had proven lateral lymph node metastasis to groups receiving either']","['Intraoperative application of inactivated Pseudomonas aeruginosa', '2 mL Pseudomonas aeruginosa spray (Pseudomonas aeruginosa group) or 2 mL saline spray (control group) in the lateral cervical surgical field', 'placebo']","['macroscopic chylous fistula', 'red blood cell count', 'postoperative recurrence', 'severe side effects', 'red blood cell count and triglyceride level in the drainage, the white blood cell count in the blood, fever, local pain, development of a pleural effusion, and tumor recurrence', 'rate of chylous fistula, mean difference in the duration and volume of drainage fluid, days of postoperative hospital stay, and overall cost', 'volume of drainage fluid, fewer postoperative days of hospital stay', 'fever, pain, or pleural effusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C1096666', 'cui_str': 'Thyroid cancer metastatic'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C1066168', 'cui_str': 'Pseudomonas aeruginosa group'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0443174', 'cui_str': 'Chylous'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0521158', 'cui_str': 'Recurrent tumor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205388', 'cui_str': 'Few'}]",200.0,0.224468,"There were fewer days to drain-tube removal, a less volume of drainage fluid, fewer postoperative days of hospital stay, and a lesser red blood cell count in the drainage fluid in the Pseudomonas aeruginosa group than in the control group (all P < .05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Genpeng', 'Affiliation': 'Thyroid Surgery Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Jinen', 'Affiliation': 'State Key Laboratory of Biotherapy, West China Hospital, Sichuan University and Collaborative Innovation Center, Chengdu, Sichuan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tao', 'Affiliation': 'Thyroid Surgery Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhihui', 'Affiliation': 'Thyroid Surgery Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Gong', 'Initials': 'G', 'LastName': 'Rixiang', 'Affiliation': 'Thyroid Surgery Center, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jianyong', 'Affiliation': 'Thyroid Surgery Center, West China Hospital of Sichuan University, Chengdu, China. Electronic address: leijianyong11@163.com.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Jingqiang', 'Affiliation': 'Thyroid Surgery Center, West China Hospital of Sichuan University, Chengdu, China.'}]",Surgery,['10.1016/j.surg.2020.03.020']
2966,32439189,The Use of Topical Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children: A Randomized Controlled Trial.,"OBJECTIVES


To determine whether the use of topical nitroglycerin patch increases radial artery diameter and facilitate cannulation in children.
DESIGN


Randomized controlled trial.
SETTING


Cairo University Hospital.
PARTICIPANTS


Children ages 2 to 8 years old scheduled for cardiac surgery.
INTERVENTION


In the nitroglycerin group (n = 20), a gauze-covered, half-sized nitroglycerin patch (5 mg) was applied at the site of radial pulsation 1 hour before induction of anesthesia. In the control group (n = 20), a gauze pad was applied to the bare skin at the site of radial pulsation with no intervention.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was the diameter of the radial artery in both limbs using ultrasonography. Other outcomes included the degree of arterial palpability, number of arterial punctures, and incidence of successful first puncture cannulation. The radial artery diameter increased after 30 minutes and 60 minutes compared with the baseline value in the nitroglycerin group in both limbs, whereas no change was reported in the radial artery diameter in the control group. The nitroglycerin group showed a greater incidence of successful first cannulation trial, a fewer number of trials, and a shorter cannulation time compared with the control group. There were no significant hypotensive episodes in any patient.
CONCLUSION


Local application of a half-sized, 5 mg nitroglycerin patch for 60 minutes in children increased the radial artery diameter bilaterally, increased the rate of first trial success, and decreased the time needed for arterial cannulation without significant hypotensive episodes.",2020,"The radial artery diameter increased after 30 minutes and 60 minutes compared with the baseline value in the nitroglycerin group in both limbs, whereas no change was reported in the radial artery diameter in the control group.","['Cairo University Hospital', 'Children', 'Children ages 2 to 8 years old scheduled for cardiac surgery', 'children']","['topical nitroglycerin patch', 'nitroglycerin patch', 'Topical Nitroglycerin', 'nitroglycerin', 'gauze-covered, half-sized nitroglycerin patch']","['radial artery diameter', 'time needed for arterial cannulation', 'shorter cannulation time', 'degree of arterial palpability, number of arterial punctures, and incidence of successful first puncture cannulation', 'incidence of successful first cannulation trial', 'radial artery diameter bilaterally', 'diameter of the radial artery in both limbs using ultrasonography', 'rate of first trial success', 'hypotensive episodes']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0699222', 'cui_str': 'Nitroglycerin Transdermal System'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0439844', 'cui_str': 'Covered'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0189586', 'cui_str': 'Puncture of artery'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0520541', 'cui_str': 'Hypotensive episode'}]",,0.261277,"The radial artery diameter increased after 30 minutes and 60 minutes compared with the baseline value in the nitroglycerin group in both limbs, whereas no change was reported in the radial artery diameter in the control group.","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasanin', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amel', 'Initials': 'A', 'LastName': 'Aboelela', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt. Electronic address: maha.mostafa@cu.edu.eg.'}, {'ForeName': 'Rehab Mohamed', 'Initials': 'RM', 'LastName': 'Mansour', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Kareem', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.04.035']
2967,32440723,Polymer-free drug-coated vs. bare-metal coronary stents in patients undergoing non-cardiac surgery: a subgroup analysis of the LEADERS FREE trial.,"AIMS


To compare the outcomes of patients undergoing non-cardiac surgery (NCS) after PCI with either a drug-coated stent (DCS) or a bare-metal stent (BMS), followed by 1-month dual antiplatelet therapy and to explore the impact of the timing of NCS.
METHODS


This is a subgroup analysis of the LEADERS FREE trial. The primary safety end point was a composite of cardiac death, myocardial infarction, or stent thrombosis, and the primary efficacy end point was clinically driven target lesion revascularization (TLR).
RESULTS


Out of 2432 patients included in the LEADERS FREE trial, 278 (11.4%) underwent NCS within 1 year after PCI. Among NCS patients, the 1-year safety end point was numerically lower with DCS; however, this difference was not significant as compared to BMS (4.7% vs. 10.1%, HR: 0.459 [0.178-1.183], p = 0.099), clinically driven TLR was significantly lower after DCS (2.4% vs. 8.3%, HR: 0.281 [0.079-0.996], p = 0.036), and BARC 3-5 bleeding was similar with DCS vs. BMS (10.2% vs. 7.5%, p = 0.438). In patients treated with BMS, NCS within 3 months after PCI was associated with higher incidence of the safety end point than NCSs performed later: 14.9% vs. 4.4%, HR: 3.586 [1.012-12.709], p = 0.034. The timing of surgery had no impact on patients treated with DCS (4.7% vs. 4.7%, p = 0.947).
CONCLUSIONS


Among patients undergoing NCS after PCI, DCS-treated patients had a lower probability of clinically driven TLR compared with BMS. However, there was no significant difference in the occurrence of the primary composite safety end point or bleeding complications. Early NCS after BMS-PCI was associated with impaired safety, while the timing of NCS had no such influence after DCS implantation.",2020,"Early NCS after BMS-PCI was associated with impaired safety, while the timing of NCS had no such influence after DCS implantation.","['patients undergoing non-cardiac surgery', 'Out of 2432 patients included in the LEADERS FREE trial, 278 (11.4', 'patients undergoing non-cardiac surgery (NCS) after PCI with either a']","['Polymer-free drug-coated vs. bare-metal coronary stents', 'drug-coated stent (DCS) or a bare-metal stent (BMS', 'NCS', 'BMS, NCS']","['BMS', 'occurrence of the primary composite safety end point or bleeding complications', 'composite of cardiac death, myocardial infarction, or stent thrombosis, and the primary efficacy end point was clinically driven target lesion revascularization (TLR', 'clinically driven TLR', 'BARC 3-5 bleeding', 'probability of clinically driven TLR', '1-year safety end point']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C1445093', 'cui_str': 'Drug coated stent'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439234', 'cui_str': 'year'}]",2432.0,0.195791,"Early NCS after BMS-PCI was associated with impaired safety, while the timing of NCS had no such influence after DCS implantation.","[{'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Heart Center, Segeberger Kliniken, Am Kurpark 1, 23795, Bad Segeberg, Germany.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abdelghani', 'Affiliation': 'Heart Center, Segeberger Kliniken, Am Kurpark 1, 23795, Bad Segeberg, Germany.'}, {'ForeName': 'Abdelhakim', 'Initials': 'A', 'LastName': 'Allali', 'Affiliation': 'Heart Center, Segeberger Kliniken, Am Kurpark 1, 23795, Bad Segeberg, Germany. abdelhakim.allali@segebergerkliniken.de.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Toelg', 'Affiliation': 'Heart Center, Segeberger Kliniken, Am Kurpark 1, 23795, Bad Segeberg, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdellaoui', 'Affiliation': 'Groupe Hospitalier Mutualiste de Grenoble (GHM), Grenoble, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krackhardt', 'Affiliation': 'Charité Campus Virchow Klinikum, Berlin, Germany.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Wiseth', 'Affiliation': 'Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Cardiovascular European Research Center CERC, Massy, France.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Copt', 'Affiliation': 'Biosensors Clinical Research, Morges, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Stoll', 'Affiliation': 'Biosensors Clinical Research, Morges, Switzerland.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Urban', 'Affiliation': 'Hopital LaTour, Geneva, Switzerland.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01672-3']
2968,32440730,Prebiotic effect of inulin-type fructans on faecal microbiota and short-chain fatty acids in type 2 diabetes: a randomised controlled trial.,"PURPOSE


Compared to a healthy population, the gut microbiota in type 2 diabetes presents with several unfavourable features that may impair glucose regulation. The aim of this study was to evaluate the prebiotic effect of inulin-type fructans on the faecal microbiota and short-chain fatty acids (SCFA) in patients with type 2 diabetes.
METHODS


The study was a placebo controlled crossover study, where 25 patients (15 men) aged 41-71 years consumed 16 g of inulin-type fructans (a mixture of oligofructose and inulin) and 16-g placebo (maltodextrin) for 6 weeks in randomised order. A 4-week washout separated the 6 weeks treatments. The faecal microbiota was analysed by high-throughput 16S rRNA amplicon sequencing and SCFA in faeces were analysed using vacuum distillation followed by gas chromatography.
RESULTS


Treatment with inulin-type fructans induced moderate changes in the faecal microbiota composition (1.5%, p = 0.045). A bifidogenic effect was most prominent, with highest positive effect on operational taxonomic units (OTUs) of Bifidobacterium adolescentis, followed by OTUs of Bacteroides. Significantly higher faecal concentrations of total SCFA, acetic acid and propionic acid were detected after prebiotic consumption compared to placebo. The prebiotic fibre had no effects on the concentration of butyric acid or on the overall microbial diversity.
CONCLUSION


Six weeks supplementation with inulin-type fructans had a significant bifidogenic effect and induced increased concentrations of faecal SCFA, without changing faecal microbial diversity. Our findings suggest a moderate potential of inulin-type fructans to improve gut microbiota composition and to increase microbial fermentation in type 2 diabetes.
TRIAL REGISTRATION


The trial is registered at clinicaltrials.gov (NCT02569684).",2020,"Significantly higher faecal concentrations of total SCFA, acetic acid and propionic acid were detected after prebiotic consumption compared to placebo.","['type 2 diabetes', '25 patients (15 men) aged 41-71\xa0years consumed 16\xa0g of inulin-type fructans (a mixture of oligofructose and inulin) and 16-g', 'patients with type 2 diabetes']","['placebo (maltodextrin', 'inulin-type fructans', 'placebo']","['faecal concentrations of total SCFA, acetic acid and propionic acid', 'faecal microbiota and short-chain fatty acids (SCFA', 'faecal microbiota and short-chain fatty acids', 'microbial fermentation', 'faecal microbiota', 'faecal microbiota composition', 'concentrations of faecal SCFA']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456636', 'cui_str': '16G'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0907858', 'cui_str': 'oligofructose'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016743', 'cui_str': 'Levans'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0033482', 'cui_str': 'Propanoic Acids'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0015852', 'cui_str': 'Fermentation'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",,0.0995287,"Significantly higher faecal concentrations of total SCFA, acetic acid and propionic acid were detected after prebiotic consumption compared to placebo.","[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Birkeland', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway. eline.birkeland@ous-hf.no.'}, {'ForeName': 'Sedegheh', 'Initials': 'S', 'LastName': 'Gharagozlian', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kåre I', 'Initials': 'KI', 'LastName': 'Birkeland', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Valeur', 'Affiliation': 'Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Måge', 'Affiliation': 'Nofima-Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Rud', 'Affiliation': 'Nofima-Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Aas', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway.'}]",European journal of nutrition,['10.1007/s00394-020-02282-5']
2969,32439823,Slowed Metabolic Decline after One Year of Oral Insulin Treatment among Individuals at High Risk for Type 1 Diabetes in the Diabetes Prevention Trial-Type 1 and TrialNet Oral Insulin Prevention Trials.,"We assessed whether oral insulin slowed metabolic decline after 1 year of treatment in individuals at high risk for type 1 diabetes. Two oral insulin trials that were negative overall with type 1 diabetes as the primary endpoint were analyzed: the Diabetes Prevention Trial-Type 1 (DPT-1) and TrialNet oral insulin trials. Oral glucose tolerance tests at baseline and after 1 year of treatment were analyzed. Among those at high risk [Diabetes Prevention Trial Risk Score (DPTRS)≥6.75], the AUC C-peptide increased significantly from baseline to 1 year in each oral insulin group, whereas AUC glucose increased significantly in each placebo group. At 1 year, AUC C-peptide/AUC glucose was significantly higher (p<0.05) in the oral insulin group than in the placebo group in each trial (p=0.057 with age adjustment in the TrialNet trial; p<0.01 for trials combined with or without age adjustment). For DPTRS<6.75, oral insulin groups did not differ from placebo groups. The findings suggest that 1 year of treatment with oral insulin slows metabolic deterioration in individuals at high risk for type 1 diabetes. Moreover, the findings further suggest that metabolic endpoints can be useful adjuncts to the diagnostic endpoint in assessments of preventive treatments for the disorder.",2020,AUC glucose was significantly higher (p<0.05) in the oral insulin group than in the placebo group in each trial,['individuals at high risk for type 1 diabetes'],"['oral insulin', 'placebo']","['AUC glucose', 'Slowed Metabolic Decline', 'AUC C-peptide', 'Oral glucose tolerance tests']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",,0.112215,AUC glucose was significantly higher (p<0.05) in the oral insulin group than in the placebo group in each trial,"[{'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Sosenko', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL; jsosenko@med.miami.edu.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Skyler', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Kevan C', 'Initials': 'KC', 'LastName': 'Herold', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Desmond A', 'Initials': 'DA', 'LastName': 'Schatz', 'Affiliation': 'University of Florida Diabetes Institute, Gainesville, FL,.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Haller', 'Affiliation': 'University of Florida Diabetes Institute, Gainesville, FL,.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pugliese', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cleves', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Geyer', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Rafkin', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Matheson', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Palmer', 'Affiliation': 'University of Washington School of Medicine, Seattle WA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes,['10.2337/db20-0166']
2970,31471827,Offering male endoscopists as decoy option to nudge disinclined women to have colorectal cancer screening.,"Previous studies have shown that a large proportion of women invited for bowel cancer screening prefer endoscopists of the same gender. We tested whether women who are initially disinclined to undergo flexible sigmoidoscopy screening would be more willing to have the test with a female practitioner if they were also offered a decoy appointment with a male practitioner. We conducted two online experiments with women aged 35-54, living in England, who did not intend to undergo flexible sigmoidoscopy screening. In both experiments, women were randomised to two conditions: (1) control (appointment with a female endoscopist) and (2) decoy (two appointments to choose from, one with a male endoscopist and one with a female endoscopist). Experiment 1 (N = 302) verified the conditions for the decoy using a conventional intention scale, while experiment 2 (N = 300) tested how the presence of the decoy influences the likelihood of women choosing the appointment with the female practitioner in a discrete choice task. While experiment 1 showed that the presence of the decoy increased intentions to attend the appointment with the female practitioner (p = 0.02), experiment 2 confirmed that women were more likely to choose the appointment with the female endoscopist if they were also offered the decoy (p < 0.001). In both experiments, the presence of the decoy decreased perceived difficulty of the screening decision and cognitive effort required to make the decision. Offering disinclined women a male practitioner increased intention to have the test with an endoscopist of the same gender. This suggests that male screening practitioners can be used as decoy options to increase the likelihood that women choose female practitioners and facilitate the screening decision.",2020,"In both experiments, the presence of the decoy decreased perceived difficulty of the screening decision and cognitive effort required to make the decision.","['women who are initially disinclined to undergo flexible sigmoidoscopy screening would be more willing to have the test with a female practitioner if they were also offered a decoy appointment with a male practitioner', 'women aged 35-54, living in England, who did not intend to undergo flexible sigmoidoscopy screening', 'male screening practitioners']","['control (appointment with a female endoscopist) and (2) decoy (two appointments to choose from, one with a male endoscopist and one with a female endoscopist']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy (procedure)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],302.0,0.0316634,"In both experiments, the presence of the decoy decreased perceived difficulty of the screening decision and cognitive effort required to make the decision.","[{'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Stoffel', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, 1-19 Torrington Place, WC1E 6BT, London, UK.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Kerrison', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, 1-19 Torrington Place, WC1E 6BT, London, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, University of Warwick, Coventry, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'von Wagner', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, 1-19 Torrington Place, WC1E 6BT, London, UK. c.wagner@ucl.ac.uk.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00095-4']
2971,32439224,Effect of Vehicle and Agitation Methods on the Penetration of Calcium Hydroxide Paste in the Dentinal Tubules.,"INTRODUCTION


The aim of this ex vivo study was to analyze the effect of different vehicles combined with agitation methods on the penetration of calcium hydroxide (CH) paste in the dentinal tubules.
METHODS


Sixty freshly extracted, single-rooted human premolars were prepared using WaveOne Gold (Dentsply Sirona, York, PA) and randomized into 6 experimental groups (n = 10) according to the vehicle and method of paste agitation as follows: propylene glycol (PG) + Lentulo, PG + Lentulo + ultrasound, PG + Lentulo + sonic, distilled water (DW) + Lentulo, DW + Lentulo + ultrasonic, and DW + Lentulo + sonic. The CH paste was manipulated with sodium fluorescein dye and was inserted to completely fill the root canal. Two 1-mm thick sections at 2 mm and 5 mm from the apex of each root were obtained. The sections were scanned using confocal laser scanning microscopy, and the images were analyzed using ImageJ software (Bethesda, MD) to calculate the percentage penetration and maximum penetration depth of CH paste. Statistical analysis was performed using 1-way analysis of variance and Tukey honestly significant difference post hoc tests.
RESULTS


No statistically significant differences between study factors at a distance of 2 mm from the apex were observed (P > .05). However, at 5 mm, a significant difference between the vehicles (P < .05) in percentage penetration was demonstrated with higher means for PG.
CONCLUSIONS


Vehicles interfered with the penetration of CH in the dentinal tubules at 5 mm from the apex with better results for PG.",2020,"However, at 5 mm, a significant difference between the vehicles (P < .05) in percentage penetration was demonstrated with higher means for PG.
","['Sixty freshly extracted, single-rooted human premolars']","['Vehicle and Agitation Methods', 'sodium fluorescein dye', 'WaveOne Gold (Dentsply Sirona, York, PA', 'calcium hydroxide', 'paste agitation as follows: propylene glycol (PG) + Lentulo, PG + Lentulo + ultrasound, PG + Lentulo + sonic, distilled water (DW) + Lentulo, DW + Lentulo + ultrasonic, and DW + Lentulo + sonic']",['Penetration of Calcium Hydroxide Paste'],"[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0147866', 'cui_str': 'Fluorescein sodium stain'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0112984', 'cui_str': 'Dentsply'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0790233', 'cui_str': 'Distilled water'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}]",60.0,0.0523159,"However, at 5 mm, a significant difference between the vehicles (P < .05) in percentage penetration was demonstrated with higher means for PG.
","[{'ForeName': 'Mariana Barbosa', 'Initials': 'MB', 'LastName': 'de Almeida', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Kauhanna Vianna', 'Initials': 'KV', 'LastName': 'de Oliveira', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Vinícius Rodrigues', 'Initials': 'VR', 'LastName': 'Dos Santos', 'Affiliation': 'Piracicaba Dental School, Universidade Estadual de Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Wander José', 'Initials': 'WJ', 'LastName': 'da Silva', 'Affiliation': 'Piracicaba Dental School, Universidade Estadual de Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Flávia Sens Fagundes', 'Initials': 'FSF', 'LastName': 'Tomazinho', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Flares', 'Initials': 'F', 'LastName': 'Baratto-Filho', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Marilisa Carneiro Leão', 'Initials': 'MCL', 'LastName': 'Gabardo', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil. Electronic address: marilisagabardo@gmail.com.'}]",Journal of endodontics,['10.1016/j.joen.2020.03.026']
2972,32439297,Influence of neoatherosclerosis on prognosis and treatment response in patients with in-stent restenosis.,"INTRODUCTION AND OBJECTIVES


Neoatherosclerosis is one of the causes of in-stent restenosis (ISR). Our objective was to evaluate the influence of neoatherosclerosis on prognosis and treatment response in patients with ISR.
METHODS


This is a pooled analysis of the optical coherence tomography (OCT)-substudies of 2 multicenter, randomized clinical trials, RIBS IV and V, comparing treatment with paclitaxel-coated balloon vs everolimus-eluting stent in patients with ISR. OCT evaluation was performed at baseline and at 6 to 9 months. Neoatherosclerosis was defined in baseline OCT as neointima with calcified or lipid content. We evaluated the angiographic and OCT results at 6 to 9 months and the occurrence of major adverse cardiovascular events at 3 years of follow-up in patients with and without neoatherosclerosis treated with paclitaxel-coated balloon or everolimus-eluting stents.
RESULTS


Sixty-four patients underwent OCT at the time of the index procedure. Neoatherosclerosis was documented in 23 (36%) lesions. Angiographic follow-up at 6 to 9 months showed no differences in restenosis [5 (24%) vs 6 (15%) P=.49], minimum lumen diameter (1.79±0.7 vs 1.94±0.6mm; P=.41) or late loss (0.33±0.7 vs 0.15±0.5; P=.34) in patients with and without neoatherosclerosis, respectively. Follow-up OCT confirmed the absence of differences in quantitative parameters and the characteristics of tissue coverage between the 2 groups. At 3 years of follow-up, the major adverse cardiovascular events rate was 3 (13%) vs 5 (12%) in the neoatherosclerosis and nonneoatherosclerosis groups (HR, 0.94; 95%CI, 0.22-3.93; P=.93).
CONCLUSIONS


In this limited study population, OCT-defined neoatherosclerosis did not seem to influence acute and long-term outcomes in patients randomized to paclitaxel-coated balloon or everolimus-eluting stents for ISR.",2020,"Angiographic follow-up at 6 to 9 months showed no differences in restenosis [5 (24%) vs 6 (15%) P=.49], minimum lumen diameter (1.79±0.7 vs 1.94±0.6mm;","['patients with in-stent restenosis', 'patients with ISR']","['OCT', 'paclitaxel-coated balloon vs everolimus-eluting stent', 'paclitaxel-coated balloon or everolimus-eluting stents', 'neoatherosclerosis']","['Neoatherosclerosis', 'late loss', 'minimum lumen diameter', 'OCT evaluation', 'major adverse cardiovascular events rate', 'restenosis', 'occurrence of major adverse cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",64.0,0.0397802,"Angiographic follow-up at 6 to 9 months showed no differences in restenosis [5 (24%) vs 6 (15%) P=.49], minimum lumen diameter (1.79±0.7 vs 1.94±0.6mm;","[{'ForeName': 'Nieves', 'Initials': 'N', 'LastName': 'Gonzalo', 'Affiliation': 'Departamento de Cardiología Intervencionista, Hospital Universitario Clínico San Carlos, IdISSC, Universidad Complutense, Madrid, Spain. Electronic address: nieves_gonzalo@yahoo.es.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Salazar', 'Affiliation': 'Departamento de Cardiología Intervencionista, Hospital Universitario Clínico San Carlos, IdISSC, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Pérez-Vizcayno', 'Affiliation': 'Departamento de Cardiología Intervencionista, Hospital Universitario Clínico San Carlos, IdISSC, Universidad Complutense, Madrid, Spain; Fundación Interhospitalaria para la Investigación Cardiovascular (FIC), Madrid, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Gómez-Polo', 'Affiliation': 'Departamento de Cardiología Intervencionista, Hospital Universitario Clínico San Carlos, IdISSC, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Jiménez-Quevedo', 'Affiliation': 'Departamento de Cardiología Intervencionista, Hospital Universitario Clínico San Carlos, IdISSC, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Jiménez-Valero', 'Affiliation': 'Departamento de Cardiología Intervencionista, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Masotti', 'Affiliation': 'Departamento de Cardiología Intervencionista, Hospital Universitario Clínic, Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romaguera', 'Affiliation': ""Departamento de Cardiología Intervencionista, Hospital Universitario Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Fernández-Ortiz', 'Affiliation': 'Departamento de Cardiología Intervencionista, Hospital Universitario Clínico San Carlos, IdISSC, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Departamento de Cardiología Intervencionista, Hospital Universitario Clínico San Carlos, IdISSC, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alfonso', 'Affiliation': 'Departamento de Cardiología Intervencionista, Hospital Universitario de la Princesa, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Macaya', 'Affiliation': 'Departamento de Cardiología Intervencionista, Hospital Universitario Clínico San Carlos, IdISSC, Universidad Complutense, Madrid, Spain.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2020.03.005']
2973,32439482,Inflammatory and fibroblastic effects of azithromycin on cyclosporine-induced gingival overgrowth in renal transplanted patients with and without scaling: A randomized clinical trial.,"BACKGROUND


This study aimed to evaluate the effect of azithromycin (AZM) on the inflammatory and fibroblastic part of cyclosporine A (CsA)-induced gingival overgrowth (GO) in renal transplanted patients.
METHODS


In this randomized clinical trial, subjects with GO receiving CsA were randomly divided into two groups: those receiving 5-day AZM only (n=12; group 1) and those receiving scaling and prescribed AZM after 2 months (n=12; group 2). Both groups were evaluated for several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length) at the first visit and the 4th and 8th week in group 1, and at the first visit and the 4th, 8th, 12th, and 16th week in group 2.
RESULTS


The sample included 24 individuals. The mean (SD) age of participants was 30.81 (11.13) and 34.80 (9.33) years in group 1 and 2, respectively. Based on ANCOVA, the changes in the hyperplastic index (GHI) and apico-coronal dimension (ACD) of it were statistically significant in professional scaling accompanied by AZM group (P = 0.012 and 0.031, respectively). However, no significant change was observed in mean indices after prescribing AZM in 5-day AZM regimen group (P = 0.664 and 0.882, respectively). According to one-way ANOVA, we found a statistically significant correlation in GHI, ACD, bleeding index (BI), and plaque index (PI) accounting for P = 0.012, 0.003, 0.002, and <0.001, respectively.
CONCLUSIONS


Findings suggest that AZM cannot influence the fibroblastic part of GO in presence of gum inflammation while the therapy can improve GO after resolving it with scaling.",2020,"Both groups were evaluated for several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length) at the first visit and the 4th and 8th week in group 1, and at the first visit and the 4th, 8th, 12th, and 16th week in group 2.
","['renal transplanted patients', 'The sample included 24 individuals', 'renal transplanted patients with and without scaling', 'subjects with GO receiving CsA']","['cyclosporine A (CsA)-induced gingival overgrowth (GO', 'AZM', 'receiving scaling and prescribed AZM', '5-day AZM', 'azithromycin (AZM', 'azithromycin', 'cyclosporine']","['gingival overgrowth', 'several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length', 'GHI, ACD, bleeding index (BI), and plaque index (PI', 'Inflammatory and fibroblastic effects', 'hyperplastic index (GHI) and apico-coronal dimension (ACD', 'mean indices', 'professional scaling']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376480', 'cui_str': 'Gingival enlargement'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0376480', 'cui_str': 'Gingival enlargement'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0376480', 'cui_str': 'Gingival enlargement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",24.0,0.0349711,"Both groups were evaluated for several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length) at the first visit and the 4th and 8th week in group 1, and at the first visit and the 4th, 8th, 12th, and 16th week in group 2.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Beihaghi', 'Affiliation': 'Private Office, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Periodontics, School of Dentistry, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Zarei', 'Affiliation': 'Department of Oral Medicine, School of Dentistry, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Azmandian', 'Affiliation': 'Department of Nephrology, Shafa Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Hamidreza Baghani', 'Initials': 'HB', 'LastName': 'Aval', 'Affiliation': 'Department of Urology, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran. Electronic address: https://mail.google.com/mail/u/0/h/sif60x9sjdad/?&cs=wh&v=b&to=hamidreza_baghani@yahoo.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': 'Department of Social Medicine, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Journal of oral biosciences,['10.1016/j.job.2020.04.001']
2974,32439422,Development and piloting of a blended learning training programme for physicians and medical students to enhance their competences in evidence-based decision-making.,"INTRODUCTION


In 2016, the German Network for Evidence-based Medicine revised its basic curriculum for competences in evidence-based medicine. A curriculum-based training programme for physicians and medical students to enhance their competences in evidence-based decision-making was developed. The training programme was planned on the basis of problem-based learning. The aim of this qualitative pilot study was to explore the feasibility and acceptability of the training programme. Hypotheses concerning its influence on critical health literacy and the attitude toward evidence-based decision-making were to be generated.
METHODS


Participating healthcare professionals received a structured training in a blended learning format. Data collection was conducted during the training sessions. The lessons were observed and protocolled and the working results were documented. Two focus group interviews were conducted after the training blocks with focus on acceptability and feasibility of the training programme. Interview transcripts and protocols were analysed using qualitative content analysis according to Mayring. Data saturation was intended by an iterative process of testing, analysing and revising the training programme. In addition, critical health literacy was assessed using the validated Critical Health Competence test. Levels of competence were calculated to measure the effect of the training on critical health competences.
RESULTS


Two pilot courses with 29 physicians and other healthcare professionals were conducted between January and March 2019. Overall, the training programme proved to be feasible. The participants rated the comprehensibility of the learning modules as high. However, the practical exercises (e.g. role plays in shared decision-making) revealed that relevant subjects were insufficiently understood (e.g. the difference between the benefits and harms of a diagnostic test and its test accuracy). The interactive instructional design was appreciated. The participants appraised the work tasks as comprehensible but also challenging and requested a theoretical introduction to statistical terms in preparation for work tasks. The programme was revised iteratively according to the results. Critical health competences increased significantly after the training. Mean values (±SD) of levels of competence were 571.21 (±82.87) before training and 671.90 (±51.38) after training (p<0.0001) (levels of competence with a range from 0 to 1,000).
CONCLUSION


The training programme is feasible and was well accepted by the participants. It should be established as a continuing medical education opportunity for practitioners. Evaluation in a randomised controlled trial is recommended. Furthermore, the training can easily be adapted for interprofessional training. A concept for long-term implementation is needed.",2020,Critical health competences increased significantly after the training.,"['physicians and medical students', 'Participating healthcare professionals', '29 physicians and other healthcare professionals were conducted between January and March 2019']","['curriculum-based training programme', 'structured training in a blended learning format', 'blended learning training programme']","['feasibility and acceptability', 'Critical health competences', 'Mean values (±SD) of levels of competence']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0398525,Critical health competences increased significantly after the training.,"[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Hinneburg', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. Electronic address: jana.hinneburg@medizin.uni-halle.de.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hecht', 'Affiliation': 'School of Nursing Science, Faculty of Health, University of Witten/Herdecke, Witten/Herdecke, Germany. Electronic address: hecht@red-institut.de.'}, {'ForeName': 'Birte', 'Initials': 'B', 'LastName': 'Berger-Höger', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. Electronic address: birte.berger-hoeger@medizin.uni-halle.de.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Buhse', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. Electronic address: susanne.buhse@uni-hamburg.de.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lühnen', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. Electronic address: julia.luehnen@medizin.uni-halle.de.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Steckelberg', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. Electronic address: anke.steckelberg@medizin.uni-halle.de.'}]","Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen",['10.1016/j.zefq.2020.02.004']
2975,32439432,"Low-dose capsaicin (0.01 mM) nasal spray is equally effective as the current standard treatment for idiopathic rhinitis: a randomized, double-blind, placebo-controlled trial.",,2020,,['idiopathic rhinitis'],"['Low-dose capsaicin', 'placebo']",[],"[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.306706,,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Van Gerven', 'Affiliation': 'University Hospitals Leuven, Clinical division of Otorhinolaryngology, Head & Neck Surgery, Leuven, Belgium; KU Leuven, Department of Microbiology, Immunology and transplantation, Allergy and Clinical Immunology Research Unit, Leuven, Belgium. Electronic address: laura.vangerven@uzleuven.be.'}, {'ForeName': 'Brecht', 'Initials': 'B', 'LastName': 'Steelant', 'Affiliation': 'KU Leuven, Department of Microbiology, Immunology and transplantation, Allergy and Clinical Immunology Research Unit, Leuven, Belgium.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Cools', 'Affiliation': 'University Hospitals Leuven, Clinical division of Otorhinolaryngology, Head & Neck Surgery, Leuven, Belgium.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Callebaut', 'Affiliation': 'University Hospitals Leuven, Clinical division of Otorhinolaryngology, Head & Neck Surgery, Leuven, Belgium.'}, {'ForeName': 'Wout', 'Initials': 'W', 'LastName': 'Backaert', 'Affiliation': 'KU Leuven, Department of Microbiology, Immunology and transplantation, Allergy and Clinical Immunology Research Unit, Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'de Hoon', 'Affiliation': 'University Hospitals Leuven, Center for Clinical Pharmacology, Leuven, Belgium.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Ampe', 'Affiliation': 'University Hospitals Leuven, Center for Clinical Pharmacology, Leuven, Belgium.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Talavera', 'Affiliation': 'KU Leuven, Laboratory for Ion Channel Research and TRP Research Platform Leuven (TRPLe), Department of Cellular and Molecular Medicine, Leuven, Belgium.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Hellings', 'Affiliation': 'University Hospitals Leuven, Clinical division of Otorhinolaryngology, Head & Neck Surgery, Leuven, Belgium; KU Leuven, Department of Microbiology, Immunology and transplantation, Allergy and Clinical Immunology Research Unit, Leuven, Belgium; Academic Medical Center Amsterdam, Department of Otorhinolaryngology, Amsterdam, the Netherlands; University of Ghent, Department of Otorhinolaryngology, Laboratory of Upper Airways Research, Ghent, Belgium.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.04.054']
2976,32439466,"Efficacy and safety of hydroxychloroquine for treatment of patients with rosacea: a multi-center, randomized, double-blind, double-dummy, pilot study.",,2020,,['patients with rosacea'],['hydroxychloroquine'],['Efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.647625,,"[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Dermatology, Xiangya Hospital, Central South University, Changsha, Hunan, China; National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Dermatology, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Preventive Medicine, the Medicine School of Hunan Normal University, Changsha, Hunan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Dermatology, Xiangya Hospital, Central South University, Changsha, Hunan, China; National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Zhixiang', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Dermatology, Xiangya Hospital, Central South University, Changsha, Hunan, China; National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Guangdong Provincial Dermatology Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Baoqi', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Shandong Provincial Hospital of Dermatology, Jinan, Shandong, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Hongfu', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Dermatology, Xiangya Hospital, Central South University, Changsha, Hunan, China; National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, Hunan, China; Key Laboratory of Organ Injury, Aging and Regenerative Medicine of Hunan Province, Central South University, Changsha, Hunan, China. Electronic address: xiehongfu1964@aliyun.com.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Xiangya Hospital, Central South University, Changsha, Hunan, China; National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, Hunan, China; Key Laboratory of Organ Injury, Aging and Regenerative Medicine of Hunan Province, Central South University, Changsha, Hunan, China; Center for Molecular Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China. Electronic address: liji_xy@csu.edu.cn.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.05.050']
2977,32439603,The effects of imaginary eating on visual food cue reactivity: An event-related potential study.,"Previous research has demonstrated that imagining consumption of a specific type of food helps individuals to consume less of that food. The present event-related potential study aimed at investigating the underlying neural correlates of this appetite-reducing strategy. A total of 86 women (mean age = 23.65 years) were randomly assigned to one of three imagination conditions. In each condition, they listened to a guided imagery script that either described the eating of 30 colorful button-shaped chocolates (M&Ms), the sorting of 30 M&Ms by color, or the sorting of 30 marbles by color. Subsequently to the imagery task, the participants were presented with images of M&Ms and marbles while their electroencephalogram and craving ratings were recorded. The results showed that imaginary eating did not reduce the appetitive value of M&M pictures. The M&M sorting group reported enhanced craving and showed increased late positivity toward M&M pictures (300-600 ms after picture onset) compared to the two other groups. The present findings indicate that the imagined handling of food increases food cue reactivity and that imaginary eating is not a reliable method to reduce appetite.",2020,The results showed that imaginary eating did not reduce the appetitive value of M&M pictures.,['86 women (mean age\u202f=\u202f23.65 years'],['imaginary eating'],"['enhanced craving', 'appetitive value of M&M pictures', 'visual food cue reactivity', 'electroencephalogram and craving ratings', 'late positivity toward M&M pictures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",86.0,0.0227251,The results showed that imaginary eating did not reduce the appetitive value of M&M pictures.,"[{'ForeName': 'Saša', 'Initials': 'S', 'LastName': 'Zorjan', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria; Department of Psychology, Faculty of Arts, University of Maribor, Slovenia.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Schwab', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schienle', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria. Electronic address: anne.schienle@uni-graz.at.'}]",Appetite,['10.1016/j.appet.2020.104743']
2978,32440731,Effects of probiotic supplementation on serum trimethylamine-N-oxide level and gut microbiota composition in young males: a double-blinded randomized controlled trial.,"PURPOSE


To explore whether probiotic supplementation could attenuate serum trimethylamine-N-oxide (TMAO) level and impact the intestinal microbiome composition.
DESIGN


Forty healthy males (20-25 years old) were randomized into the probiotic group (1.32 × 10 11  CFU live bacteria including strains of Lactobacillus acidophilus, Lactobacillus rhamnosus GG, Bifidobacterium animalis, and Bifidobacterium longum daily) or the control group for 4 weeks. All participants underwent a phosphatidylcholine challenge test (PCCT) before and after the intervention. Serum TMAO and its precursors (TMA, choline and betaine) were measured by UPLC-MS/MS. The faecal microbiome was analyzed by 16S rRNA sequencing.
RESULTS


Serum TMAO and its precursors were markedly increased after the PCCT. No statistical differences were observed in the probiotic and the control group in area under the curve (AUC) (14.79 ± 0.97 μmol/L 8 h vs. 19.17 ± 2.55 μmol/L 8 h, P = 0.106) and the pre- to post-intervention AUC alterations (∆AUC) (- 6.33 ± 2.00 μmol/L 8 h vs. - 0.73 ± 3.04 μmol/L 8 h, P = 0.131) of TMAO; however, higher proportion of participants in probiotic group showed their TMAO decrease after the intervention (78.9% vs. 45.0%, P = 0.029). The abundance of Faecalibacterium prausnitzii (P = 0.043) and Prevotella (P = 0.001) in the probiotic group was significantly increased after the intervention but without obvious differences in α- and β-diversity.
CONCLUSIONS


The current probiotic supplementation resulted in detectable change of intestinal microbiome composition but failed to attenuate the serum TMAO elevation after PCCT. CLINICALTRIALS.
GOV IDENTIFIER


NCT03292978. CLINICALTRIALS.GOV WEBSITE: https://clinicaltrials.gov/ct2/show/NCT03292978.",2020,"The abundance of Faecalibacterium prausnitzii (P = 0.043) and Prevotella (P = 0.001) in the probiotic group was significantly increased after the intervention but without obvious differences in α- and β-diversity.
","['young males', 'Forty healthy males (20-25\xa0years old']","['probiotic group (1.32\u2009×\u200910 11 \xa0CFU live bacteria including strains of Lactobacillus acidophilus, Lactobacillus rhamnosus GG, Bifidobacterium animalis, and Bifidobacterium longum daily', 'probiotic supplementation', 'phosphatidylcholine challenge test (PCCT']","['serum trimethylamine-N-oxide level and gut microbiota composition', 'Serum TMAO and its precursors (TMA, choline and betaine', 'serum TMAO elevation', 'area under the curve (AUC', 'TMAO decrease', 'faecal microbiome', 'Serum TMAO and its precursors', 'serum trimethylamine-N-oxide (TMAO) level', 'intestinal microbiome composition', 'pre- to post-intervention AUC alterations (∆AUC', 'abundance of Faecalibacterium prausnitzii']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0301363', 'cui_str': '5-trimethoxyamphetamine'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0317558', 'cui_str': 'Faecalibacterium prausnitzii'}]",40.0,0.108844,"The abundance of Faecalibacterium prausnitzii (P = 0.043) and Prevotella (P = 0.001) in the probiotic group was significantly increased after the intervention but without obvious differences in α- and β-diversity.
","[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan II Road, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Ping-Ping', 'Initials': 'PP', 'LastName': 'Jiang', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan II Road, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Danxia', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Division of Epidemiology, Vanderbilt Epidemiology Center, Vanderbilt University Medical Center, Nashville, TN, 37203, USA.'}, {'ForeName': 'Gong-Cheng', 'Initials': 'GC', 'LastName': 'Liao', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan II Road, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Shang-Ling', 'Initials': 'SL', 'LastName': 'Wu', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan II Road, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Ai-Ping', 'Initials': 'AP', 'LastName': 'Fang', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan II Road, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Pei-Yan', 'Initials': 'PY', 'LastName': 'Chen', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan II Road, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Wang', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan II Road, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan II Road, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Jing-An', 'Initials': 'JA', 'LastName': 'Long', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan II Road, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Rong-Huan', 'Initials': 'RH', 'LastName': 'Zhong', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan II Road, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Zhao-Yan', 'Initials': 'ZY', 'LastName': 'Liu', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan II Road, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Chun-Lei', 'Initials': 'CL', 'LastName': 'Li', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan II Road, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Dao-Ming', 'Initials': 'DM', 'LastName': 'Zhang', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan II Road, Guangzhou, 510080, People's Republic of China.""}, {'ForeName': 'Hui-Lian', 'Initials': 'HL', 'LastName': 'Zhu', 'Affiliation': ""Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan II Road, Guangzhou, 510080, People's Republic of China. zhuhl@mail.sysu.edu.cn.""}]",European journal of nutrition,['10.1007/s00394-020-02278-1']
2979,32439253,Telerehabilitation Programme as a Maintenance Strategy for COPD Patients: A 12-Month Randomized Clinical Trial.,"BACKGROUND


There is uncertainty regarding efficacy of telehealth-based approaches in COPD patients for sustaining benefits achieved with intensive pulmonary rehabilitation (PR).
RESEARCH QUESTION


To determine whether a maintenance pulmonary telerehabilitation (TelePR) programme, after intensive initial PR, is superior to usual care in sustaining over time benefits achieved by intensive PR.
STUDY DESIGN AND METHODS


A multicentre open-label pragmatic parallel-group randomized clinical trial was conducted. Two groups were created at completion of an 8-week intensive outpatient hospital PR programme. Intervention group (IG) patients were given appropriate training equipment and instructed to perform three weekly training sessions and send performance data through an app to a web-based platform. Patients in the control group (CG) were advised to exercise regularly (usual care).
RESULTS


Ninety-four patients (46 IG, 48 CG) were randomized. The analysis of covariance showed non-significant improvements in 6-min walk distance [19.9m (95% CI -4.1/+43.8)] and Chronic Respiratory Disease Questionnaire - Emotion score [0.4 points (0-0.8)] in the IG. Secondary linear mixed models showed improvements in the IG in Short Form-36 mental component summary [9.7, (4.0-15.4)] and Chronic Respiratory Disease Questionnaire - Emotion [0.5, (0.2-0.9)] scores, but there was no association between compliance and outcomes. Acute exacerbations were associated with a marginally significant decrease in 6-minute walk distance of 15.8m (-32.3/0.8) in linear models.
CONCLUSIONS


The TelePR maintenance strategy was both feasible and safe but failed to show superiority over usual care, despite improvements in some HRQoL domains. Acute exacerbations may have an important negative influence on long-term physical function. CLINICALTRIALS.
GOV IDENTIFIER


NCT03247933.",2020,"Acute exacerbations were associated with a marginally significant decrease in 6-minute walk distance of 15.8m (-32.3/0.8) in linear models.
","['Ninety-four patients (46 IG, 48 CG', 'COPD patients', 'COPD Patients']","['maintenance pulmonary telerehabilitation (TelePR) programme', 'Telerehabilitation Programme', 'appropriate training equipment and instructed to perform three weekly training sessions and send performance data through an app to a web-based platform']","['Short Form-36 mental component summary', 'Chronic Respiratory Disease Questionnaire - Emotion score', 'Acute exacerbations', '6-minute walk distance', '6-min walk distance', 'Chronic Respiratory Disease Questionnaire - Emotion']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0184015', 'cui_str': 'Training equipment'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C3164900', 'cui_str': 'Chronic respiratory disease questionnaire'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",,0.135952,"Acute exacerbations were associated with a marginally significant decrease in 6-minute walk distance of 15.8m (-32.3/0.8) in linear models.
","[{'ForeName': 'Juan B', 'Initials': 'JB', 'LastName': 'Galdiz', 'Affiliation': 'Respiratory Department, Hospital Universitario Cruces, Osakidetza, Biocruces Bizkaia Health Research Institute, CibeRes, Barakaldo, Spain. Electronic address: med001901@hotmail.com.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Gómez', 'Affiliation': ""Unitat Rehabilitació Cardio-Respiratoria, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': 'Respiratory Department, Hospital del Mar, CibeRes, Barcelona, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Guell', 'Affiliation': 'Respiratory Department, Hospital de la Santa Creu i San Pau, CibeRes, Barcelona, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Cebollero', 'Affiliation': 'Respiratory Department, Complejo Hospitalario Navarra, Pamplona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Hueto', 'Affiliation': 'Respiratory Department, Complejo Hospitalario Navarra, Pamplona, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Cejudo', 'Affiliation': 'Instituto de Biomedicina de Sevilla, Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Hospital Virgen Rocío, Sevilla, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ortega', 'Affiliation': 'Instituto de Biomedicina de Sevilla, Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Hospital Virgen Rocio, CibeRes, Sevilla, Spain.'}, {'ForeName': 'Itxaso', 'Initials': 'I', 'LastName': 'Sayago', 'Affiliation': 'Respiratory Department, Clínica Asunción, Tolosa, Gipuzkoa, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Chic', 'Affiliation': 'Internal Medicine Department (Respiratory Unit), Hospital de Mendaro, Osakidetza, Mendaro, Gipuzkoa, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Iscar', 'Affiliation': 'Respiratory Department, Hospital General de Asturias, Oviedo, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Amado', 'Affiliation': 'Respiratory Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Rodríguez Trigo', 'Affiliation': 'Respiratory Department, Hospital Álvaro Cunqueiro, Vigo, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Cossio', 'Affiliation': 'Respiratory Department, Hospital Universitary Son Espases, Palma de Mallorca, CibeRes, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Bustamante', 'Affiliation': 'Respiratory Department, Hospital Universitario Basurto, Bilbao, Spain.'}, {'ForeName': 'José Ignacio', 'Initials': 'JI', 'LastName': 'Pijoan', 'Affiliation': 'Clinical Epidemiology Unit, Hospital Universitario de Cruces, Biocruces Bizkaia, Health Research Institute, Bilbao, Spain.'}]",Archivos de bronconeumologia,['10.1016/j.arbres.2020.03.034']
2980,32439340,"Plasma kinetics of mature PCSK9, furin-cleaved PCSK9, and Lp(a) with or without administration of PCSK9 inhibitors in acute myocardial infarction.","BACKGROUND


There are two types of circulating proprotein convertase subtilisin/kexin type 9 (PCSK9), mature and furin-cleaved. Most types of lipoprotein(a) [Lp(a)], an independent risk factor of cardiovascular events, bind to mature PCSK9.
OBJECTIVE


This study examined the effects of monoclonal anti-PCSK9 antibody on plasma PCSK9 and Lp(a) levels in acute myocardial infarction (MI).
METHODS


Acute MI patients (n=36) were randomly divided into evolocumab (140mg; n=17) and non-evolocumab (n=19) groups. Changes in plasma PCSK9 and Lp(a) levels were monitored before and 1, 3, 5, 10, and 20 days after evolocumab administration.
RESULTS


In the non-evolocumab group, plasma levels of mature PCSK9, furin-cleaved PCSK9, and Lp(a) (236.4±57.3ng/mL, 22.4±5.8ng/mL, and 19.2.±16.5mg/dL, respectively) significantly increased by day 3 (408.8±77.1ng/mL, p<0.001; 47.2±15.7ng/mL, p<0.001; and 39.7±21.3mg/dL, p<0.005, respectively) and returned to the baseline by day 10 or 20. In the evolocumab group, mature PCSK9 significantly increased by >1000ng/mL with a simultaneous decline of furin-cleaved PCSK9 below the measurement sensitivity level after day 3. The incremental area under the curve for plasma Lp(a) levels was significantly smaller in the evolocumab group compared with the non-evolocumab group (p=0.038).
CONCLUSION


Mature and furin-cleaved PCSK9 are transiently upregulated after MI onset. Evolocumab significantly increases mature PCSK9 and decreases furin-cleaved PCSK9 and might inhibit transient increase of plasma Lp(a) in acute MI.",2020,"The incremental area under the curve for plasma Lp(a) levels was significantly smaller in the evolocumab group compared with the non-evolocumab group (p=0.038).
","['Acute MI patients (n=36', 'acute myocardial infarction (MI']","['monoclonal anti-PCSK9 antibody', 'evolocumab', 'non-evolocumab', 'lipoprotein(a) [Lp(a', 'PCSK9 inhibitors', 'Mature and furin']","['plasma levels of mature PCSK9, furin-cleaved PCSK9, and Lp(a', 'mature PCSK9 and decreases furin-cleaved PCSK9', 'plasma PCSK9 and Lp(a) levels', 'incremental area under the curve for plasma Lp(a) levels', 'plasma Lp(a', 'mature PCSK9']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C4522007', 'cui_str': 'PCSK9 inhibitor'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0287990', 'cui_str': 'Furin'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0205242', 'cui_str': 'Cleaved'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0369091,"The incremental area under the curve for plasma Lp(a) levels was significantly smaller in the evolocumab group compared with the non-evolocumab group (p=0.038).
","[{'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan. Electronic address: AkihiroNakamura0223@msn.com.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Kanazawa', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Kagaya', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan.'}, {'ForeName': 'Masateru', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan.'}, {'ForeName': 'Kenjiro', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Endo', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Nozaki', 'Affiliation': 'Department of Cardiology, Iwate Prefectural Central Hospital, Morioka, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2020.04.006']
2981,32439860,A randomized trial evaluating virus-specific effects of a combination probiotic in children with acute gastroenteritis.,"Gastroenteritis accounts for nearly 500,000 deaths in children younger than 5 years annually. Although probiotics have been touted as having the potential to expedite diarrhea resolution, recent clinical trials question their effectiveness. A potential explanation is a shift in pathogens following the introduction of a rotavirus vaccine. Here, we report the results of a multi-center, double-blind trial of 816 children with acute gastroenteritis who completed follow-up and provided multiple stool specimens. Participants were randomized to receive a probiotic containing Lactobacillus rhamnosus and Lactobacillus helveticus or placebo. We report no virus-specific beneficial effects attributable to the probiotic, either in reducing clinical symptoms or viral nucleic acid clearance from stool specimens collected up to 28 days following enrollment. We provide pathophysiological and microbiologic evidence to support the clinical findings and conclude that our data do not support routine probiotic administration to children with acute gastroenteritis, regardless of the infecting virus.",2020,"We report no virus-specific beneficial effects attributable to the probiotic, either in reducing clinical symptoms or viral nucleic acid clearance from stool specimens collected up to 28 days following enrollment.","['children younger than 5 years annually', '816 children with acute gastroenteritis who completed follow-up and provided multiple stool specimens', 'children with acute gastroenteritis']","['combination probiotic', 'probiotic containing Lactobacillus rhamnosus and Lactobacillus helveticus or placebo']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0317592', 'cui_str': 'Lactobacillus helveticus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],816.0,0.233591,"We report no virus-specific beneficial effects attributable to the probiotic, either in reducing clinical symptoms or viral nucleic acid clearance from stool specimens collected up to 28 days following enrollment.","[{'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Freedman', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada. Stephen.freedman@ahs.ca.""}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Nettel-Aguirre', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada.""}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Pang', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Chui', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Williamson-Urquhart', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schnadower', 'Affiliation': 'University of Cincinnati, 3333 Burnet Ave, Cincinnati, OH, UCA 45229, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Schuh', 'Affiliation': 'University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Sherman', 'Affiliation': 'University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Bonita E', 'Initials': 'BE', 'LastName': 'Lee', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gouin', 'Affiliation': 'Université de Montréal, 3175 Chemin de la Côte-Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Ken J', 'Initials': 'KJ', 'LastName': 'Farion', 'Affiliation': 'University of Ottawa, 401 Smyth Rd, Ottawa, ON, K1H 8L1, Canada.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Poonai', 'Affiliation': 'University of Western Ontario, 800 Commissioners Road E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Katrina F', 'Initials': 'KF', 'LastName': 'Hurley', 'Affiliation': 'Dalhousie University, 5980 University Avenue, PO Box 9700, Halifax, NS, B3K 6R8, Canada.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Binal', 'Initials': 'B', 'LastName': 'Ghandi', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Lloyd', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Finkelstein', 'Affiliation': 'University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature communications,['10.1038/s41467-020-16308-3']
2982,32439248,Derivation and validation of a new nutritional index for predicting 90 days mortality after ICU admission in a Korean population.,"BACKGROUND/PURPOSE


Predicting the mortality in patients admitted to the ICU is important for determining a treatment strategy and public health policy. Although many scores have been developed to predict the mortality, these scores were based on Caucasian population. We aimed to develop a new prognostic index, the New nutritional index (NNI), to predict 90-days mortality after ICU admission based on Korean population.
METHODS


Patients (1453) who admitted intensive care unit (ICU) of the Gangnam Severance hospital were analyzed. After exclusion, 984 patients were randomly divided into internal (n = 702) and external validation (n = 282) data set. The new nutritional index (NNI) was developed using univariate and multivariate logistic regression with backward selection of predictors. Receiver operating characteristic (ROC) curve analysis and comparison of the area under the curve (AUC) verified the better predictor of 90 days-mortality after ICU admission.
RESULTS


The NNI better predicted 90 days-mortality compared to modified NUTRIC score, APACHE II scores, SOFA scores, CRP, glucose, total protein, and albumin level in internal and external data sets, with AUC of 0.862 (SE: 0.017, 95% CI: 0.829-0.895) and 0.858 (SE: 0.015, 95% CI: 0.829-0.887), respectively. The calibration plots using external data set for validation showed a close approximation to the logistic calibration of each nomogram, and p-value of Hosmer and Lemeshow test was 0.1804.
CONCLUSION


The NNI has advantages as a predictor of 90 days mortality based on nutritional status in the Korean population.",2020,"The NNI better predicted 90 days-mortality compared to modified NUTRIC score, APACHE II scores, SOFA scores, CRP, glucose, total protein, and albumin level in internal and external data sets, with AUC of 0.862 (SE: 0.017, 95% CI: 0.829-0.895) and 0.858","['Patients (1453) who admitted intensive care unit (ICU) of the Gangnam Severance hospital were analyzed', '90 days mortality after ICU admission in a Korean population', '984 patients', 'patients admitted to the ICU']",[],"['modified NUTRIC score, APACHE II scores, SOFA scores, CRP, glucose, total protein, and albumin level in internal and external data sets', 'Receiver operating characteristic (ROC) curve analysis and comparison of the area under the curve (AUC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",984.0,0.0138512,"The NNI better predicted 90 days-mortality compared to modified NUTRIC score, APACHE II scores, SOFA scores, CRP, glucose, total protein, and albumin level in internal and external data sets, with AUC of 0.862 (SE: 0.017, 95% CI: 0.829-0.895) and 0.858","[{'ForeName': 'Da-Hye', 'Initials': 'DH', 'LastName': 'Son', 'Affiliation': 'Department of Family Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sub', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hye-Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Collaboration Unit, Department of Research Affairs, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: indi5645@yuhs.ac.'}, {'ForeName': 'Cheung-Soo', 'Initials': 'CS', 'LastName': 'Shin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: cheung56@yuhs.ac.'}]",Journal of the Formosan Medical Association = Taiwan yi zhi,['10.1016/j.jfma.2020.05.007']
2983,32439503,Pressure-support ventilation versus T-piece during spontaneous breathing trials before extubation among patients at high-risk of extubation failure: a post-hoc analysis of a clinical trial.,"BACKGROUND


Spontaneous breathing trial (SBT) using T-piece remains the most frequently performed trial before extubation in ICUs.
RESEARCH QUESTION


We aimed at determining whether initial SBT using pressure-support ventilation (PSV) could increase successful extubation rates among patients at high-risk of extubation failure.
STUDY DESIGN


and Methods: Post-hoc analysis of a multicenter trial focusing on reintubation in patients at high-risk of extubation failure. The initial SBT was performed using PSV or T-piece according to the physician/center decision. The primary outcome was the proportion of patients successfully extubated 72h after initial SBT, i.e. extubated after initial SBT and not reintubated within the following 72 hours.
RESULTS


Among the 641 patients included in the original study, initial SBT was performed using PSV (7.0 cm H 2 O in median without positive end-expiratory pressure) in 243 patients (38%) and using T-piece in 398 patients (62%). The proportion of patients successfully extubated 72h after initial SBT was 67% (162/243) using PSV and 56% (223/398) using T-piece (absolute difference 10.6%, 95% CI 2.8 to 28.1; p=0.0076). The proportion of patients extubated after initial SBT was 77% (186/283) using PSV and 63% (249/398) using T-piece (p=0.0002), while reintubation rates within the following 72 hours did not significantly differ (13% vs. 10%, respectively; p=0.4259). Performing an initial SBT using PSV was independently associated with successful extubation (adjusted odds ratio 1.60, 95% CI 1.30 to 2.18; p=0.0061).
INTERPRETATION


In patients at high-risk of extubation failure in the ICU, performing an initial SBT using PSV may hasten extubation without an increased risk of reintubation.",2020,"Performing an initial SBT using PSV was independently associated with successful extubation (adjusted odds ratio 1.60, 95% CI 1.30 to 2.18; p=0.0061).
","['641 patients included in the original study, initial SBT', 'patients at high-risk of extubation failure']","['Pressure-support ventilation versus T-piece', 'SBT using pressure-support ventilation (PSV']","['successful extubation', 'successful extubation rates', 'proportion of patients extubated after initial SBT', 'proportion of patients successfully extubated 72h after initial SBT', 'proportion of patients successfully extubated 72h after initial SBT, i.e. extubated after initial SBT', 'reintubation rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}]",641.0,0.20449,"Performing an initial SBT using PSV was independently associated with successful extubation (adjusted odds ratio 1.60, 95% CI 1.30 to 2.18; p=0.0061).
","[{'ForeName': 'Arnaud W', 'Initials': 'AW', 'LastName': 'Thille', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France. Electronic address: aw.thille@gmail.com.""}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Coudroy', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Mai-Anh', 'Initials': 'MA', 'LastName': 'Nay', 'Affiliation': ""Centre Hospitalier Régional d'Orléans, Médecine Intensive Réanimation, Orléans, France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Gacouin', 'Affiliation': 'Centre Hospitalier Universitaire de Rennes, Hôpital Ponchaillou, Service des Maladies Infectieuses et Réanimation Médicale, Rennes, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Demoule', 'Affiliation': 'Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine Intensive et Réanimation (Département R3S), AP-HP 6 - Sorbonne, INSERM, UMRS1158 neurophysiologie respiratoire expérimentale et clinique, Sorbonne Université, Paris, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Sonneville', 'Affiliation': 'Hôpital Bichat - Claude Bernard, Médecine Intensive Réanimation, AP-HP, Université Paris Diderot, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Beloncle', 'Affiliation': ""Centre Hospitalier Universitaire d'Angers, Département de Médecine Intensive Réanimation, Université d'Angers, Angers, France.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Girault', 'Affiliation': 'Centre Hospitalier Universitaire de Rouen, Hôpital Charles Nicolle, Département de Réanimation Médicale, Normandie Université, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), Rouen, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Dangers', 'Affiliation': 'Centre Hospitalier Universitaire Félix Guyon, Service de Réanimation Polyvalente, Saint Denis de la Réunion, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lautrette', 'Affiliation': 'Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Réanimation Médicale, Clermont-Ferrand, France.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Levrat', 'Affiliation': 'Centre Hospitalier de La Rochelle, Service de Réanimation, La Rochelle, France.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Rouzé', 'Affiliation': 'Centre Hospitalier Universitaire de Lille, Centre de Réanimation, Université de Lille, Lille, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Vivier', 'Affiliation': 'Hôpital Saint-Joseph Saint-Luc, Réanimation Polyvalente, Lyon, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': 'Centre Hospitalier Universitaire de Nantes, Médecine Intensive Réanimation, Nantes, France.'}, {'ForeName': 'Jean-Damien', 'Initials': 'JD', 'LastName': 'Ricard', 'Affiliation': 'Hôpital Louis Mourier, Réanimation Médico-Chirurgicale, AP-HP, INSERM, Université Paris Diderot, UMR IAME 1137, Sorbonne Paris Cité, Colombes, France.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Razazi', 'Affiliation': 'Hôpitaux universitaires Henri Mondor, Service de Réanimation Médicale DHU A-TVB, AP-HP, Créteil, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Barberet', 'Affiliation': 'Groupe Hospitalier Régional Mulhouse Sud Alsace, site Emile Muller, Service de Réanimation Médicale, Mulhouse, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lebert', 'Affiliation': 'Centre Hospitalier Départemental de Vendée, Service de Médecine Intensive Réanimation, La Roche Sur Yon, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': ""Centre Hospitalier Régional Universitaire de Tours, Médecine Intensive Réanimation, CIC 1415, Réseau CRICS-Trigger SEP, Centre d'étude des pathologies respiratoires, INSERM U1100, Université de Tours, Tours, France.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Massri', 'Affiliation': 'Centre Hospitalier de Pau, Service de Réanimation, Pau, France.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bourenne', 'Affiliation': 'Centre Hospitalier Universitaire La Timone 2, Médecine Intensive Réanimation, Réanimation des Urgences, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Pradel', 'Affiliation': ""Centre Hospitalier Henri Mondor d'Aurillac, Service de Réanimation, Aurillac, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bailly', 'Affiliation': 'Centre Hospitalier Universitaire de Brest, Médecine Intensive Réanimation, Brest, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Terzi', 'Affiliation': 'Centre Hospitalier Universitaire Grenoble Alpes, Médecine Intensive Réanimation, INSERM, Université Grenoble-Alpes, U1042, HP2, Grenoble, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Dellamonica', 'Affiliation': ""Centre Hospitalier Universitaire de Nice, Médecine Intensive Réanimation, Archet 1, Université Cote d'Azur, Nice, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lacave', 'Affiliation': 'Centre Hospitalier de Versailles, Service de Réanimation Médico-Chirurgicale, Le Chesnay, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Robert', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': ""INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2020.04.053']
2984,32439573,"A commentary on: ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - an open labelled, randomised control trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.0957589,,"[{'ForeName': 'Alethea', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Aneurin Bevan University Health Board, Newport, Wales.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Beamish', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea; Department of Surgical Research and Education, Institute of Clinical Sciences, Gothenburg University, Gothenburg, 41345, Sweden. Electronic address: beamishaj@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.041']
2985,32439926,Does Erector Spinae Plane Block Have a Visceral Analgesic Effect?: A Randomized Controlled Trial.,"The visceral analgesic efficacy of erector spinae plane block (ESPB) is still a matter of debate. This study attempted to investigate the visceral analgesic efficacy of ESPB in clinical setting. After randomized, we performed ultrasound-guided bilateral rectus sheath block (RSB), which was aimed to prevent postoperative somatic pain on all patients who underwent laparoscopic cholecystectomy (LC). Ultrasound-guided bilateral ESPB at T7 level was performed only to the intervention group to provide the visceral analgesic block. The intraoperative requirement for remifentanil (P = 0.021) and the cumulative fentanyl consumption at postoperative 24-hours was significantly lower in the ESPB group (206.5 ± 82.8 μg vs.283.7 ± 102.4 μg, respectively; P = 0.004) compared to non-ESPB group. The ESPB group consistently showed lower accumulated analgesic consumption compared with those in the non-ESPB group at all observed time-points (all P < 0.05) after 2 hours and the degree of the accumulated analgesic consumption reduction was greater (P = 0.04) during the 24-hour postoperative period. Pain severity was lower in the ESPB group at 6-hours postoperatively. The significantly reduced opioid consumption in ESPB group may imply that while preliminary and in need of confirmation, ESPB has potential visceral analgesic effect. Therefore, performing ESPB solely may be feasible in inducing both somatic and visceral analgesia.",2020,"The intraoperative requirement for remifentanil (P = 0.021) and the cumulative fentanyl consumption at postoperative 24-hours was significantly lower in the ESPB group (206.5 ± 82.8 μg vs.283.7 ± 102.4 μg, respectively; P = 0.004) compared to non-ESPB group.",[],"['ESPB', 'remifentanil', 'erector spinae plane block (ESPB', 'laparoscopic cholecystectomy (LC', 'ultrasound-guided bilateral rectus sheath block (RSB']","['visceral analgesic efficacy', 'analgesic consumption', 'intraoperative requirement', 'Pain severity', 'cumulative fentanyl consumption', 'analgesic consumption reduction', 'opioid consumption']",[],"[{'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",,0.05068,"The intraoperative requirement for remifentanil (P = 0.021) and the cumulative fentanyl consumption at postoperative 24-hours was significantly lower in the ESPB group (206.5 ± 82.8 μg vs.283.7 ± 102.4 μg, respectively; P = 0.004) compared to non-ESPB group.","[{'ForeName': 'Hye-Mee', 'Initials': 'HM', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Doo-Hwan', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Sung-Moon', 'Initials': 'SM', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Kyu Taek', 'Initials': 'KT', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Sooin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Hyun-Jung', 'Initials': 'HJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Jong-Hyuk', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea. leejhpain@amc.seoul.kr.'}]",Scientific reports,['10.1038/s41598-020-65172-0']
2986,32439861,Physiological and Behavioral Synchrony Predict Group Cohesion and Performance.,"Interpersonal synchrony contributes to social functioning in dyads, but it remains unknown how synchrony shapes group experiences and performance. To this end, we designed a novel group drumming task in which participants matched their drumming to either predictable or unpredictable tempos. Fifty-one three-person groups were randomly assigned to one of two conditions: synchronized or asynchronized drumming. Outcome measures included electrocardiograms and self-reports of group cohesion and synchrony. The drumming task elicited an increase in physiological synchrony between group members (specifically their hearts' interbeat intervals). We also found that physiological synchronization and behavioral synchronization predicted individuals' experience of group cohesion. Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together. The findings suggest that the behavioral and physiological consequences of synchronization contribute to the formation of group bonds and coordination. They also confirm that insights from translational social neuroscience can inform our knowledge of the development of cohesive and efficacious groups.",2020,Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together.,"['participants matched their drumming to either predictable or unpredictable tempos', 'Fifty-one three-person groups']",['synchronized or asynchronized drumming'],"['electrocardiograms and self-reports of group cohesion and synchrony', 'physiological synchrony']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",,0.0139198,Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together.,"[{'ForeName': 'Ilanit', 'Initials': 'I', 'LastName': 'Gordon', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel. Ilanit.gordon@biu.ac.il.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Gilboa', 'Affiliation': 'The Music Department, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'The Music Department, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Milstein', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Haimovich', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'Pinhasi', 'Affiliation': 'The Psychology Department, Rupin College, Emeq-Hefer, Israel.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Siegman', 'Affiliation': 'The Department of Computer Science, Bar Ilan University, Ramat-Gan, Israel.'}]",Scientific reports,['10.1038/s41598-020-65670-1']
2987,31396820,Consistent self-monitoring in a commercial app-based intervention for weight loss: results from a randomized trial.,"Self-monitoring is the strongest predictor of success in lifestyle interventions for obesity. In this secondary analysis of the GoalTracker trial, we describe outcomes of consistently self-monitoring in a standalone weight loss intervention. The 12-week intervention focused on daily self-monitoring of diet and/or body weight in a commercial app (MyFitnessPal). Participants (N = 100; 21-65 years; BMI 25-45 kg/m 2 ) were categorized as Consistent Trackers if they tracked ≥ 6 out of 7 days for at least 75% of the targeted weeks. One-fourth of participants were Consistent Trackers. This subset was more likely to be married or living with a partner, be non-Hispanic White, and have higher health literacy than Inconsistent Trackers (ps < .05). Consistent tracking was associated with greater weight change than inconsistent tracking at 1 month (mean difference [95% CI] - 1.11 kg [- 2.12, - 0.10]), 3 months (- 2.42 kg [- 3.80, - 1.04]), and 6 months (- 2.13 kg [- 3.99, - 0.27]). Over 3 times as many Consistent Trackers as Inconsistent Trackers achieved ≥ 5% weight loss at 3 months (48 vs. 13%) and at 6 months (54 vs. 15%; ps < .001). Though causality cannot be determined by the present study, tracking weight and/or diet nearly every day per week for 12 weeks in a commercial app may serve as an effective strategy for weight loss. Strategies are needed to promote greater consistency in tracking.",2020,"Consistent tracking was associated with greater weight change than inconsistent tracking at 1 month (mean difference [95% CI] - 1.11 kg [- 2.12, - 0.10]), 3 months (- 2.42 kg [- 3.80, - 1.04]), and 6 months (- 2.13 kg [- 3.99, - 0.27]).",['Participants (N\u2009=\u2009100; 21-65\xa0years; BMI 25-45\xa0kg/m 2 '],['daily self-monitoring of diet and/or body weight in a commercial app (MyFitnessPal'],"['weight change', 'weight loss']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]","[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0424349,"Consistent tracking was associated with greater weight change than inconsistent tracking at 1 month (mean difference [95% CI] - 1.11 kg [- 2.12, - 0.10]), 3 months (- 2.42 kg [- 3.80, - 1.04]), and 6 months (- 2.13 kg [- 3.99, - 0.27]).","[{'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Patel', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, USA. michele.patel@stanford.edu.'}, {'ForeName': 'Taylor L', 'Initials': 'TL', 'LastName': 'Brooks', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, USA.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Bennett', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00091-8']
2988,32439849,Effects of caffeine intake and exercise intensity on executive and arousal vigilance.,"During physical efforts and sport practice, vigilance is responsible for maintaining an optimal state of activation, guaranteeing the ability to quickly respond and detect unexpected, but critical, stimuli over time. Caffeine and physical exercise are able to modulate the activation state, affecting vigilance performance. The aim of the present work was to assess the specific effects and modulations of caffeine intake and two physical intensities on vigilance components. Participants performed an attentional task (ANTI-Vea) to measure the executive and arousal components of vigilance, in six double-blinded counterbalanced sessions combining caffeine, placebo, or no-ingestion, with light vs. moderate cyclergometer exercise. Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates. Instead, caffeine intake generally improved arousal vigilance. In conclusion, caffeine and acute exercise seems to moderate executive and arousal vigilance in different ways.",2020,"Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates.",[],"['Caffeine and physical exercise', 'caffeine', 'attentional task (ANTI-Vea', 'caffeine and acute exercise', 'caffeine intake and exercise intensity', 'caffeine, placebo, or no-ingestion, with light vs. moderate cyclergometer exercise']","['arousal vigilance', 'moderate executive and arousal vigilance', 'executive and arousal vigilance', 'executive vigilance with faster overall reaction time (RT), without impairing error rates']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0355207,"Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sanchis', 'Affiliation': 'Faculty of Physical Education & Sport Sciences, Catholic University of Valencia, Valencia, 46001, Spain. carlos.sanchis@ucv.es.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Blasco', 'Affiliation': 'Faculty of Physical Education & Sport Sciences, Catholic University of Valencia, Valencia, 46001, Spain.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Luna', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behavior Research Center, University of Granada, 18071, Granada, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Lupiáñez', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behavior Research Center, University of Granada, 18071, Granada, Spain. jlupiane@ugr.es.'}]",Scientific reports,['10.1038/s41598-020-65197-5']
2989,32440068,Comparative Microbiological Evaluation after Caries Removal by Various Burs.,"Aim


The aim of the study was to compare the caries removal efficacy in terms of bacteriology and efficiency in terms of time taken by conventional and smart burs.
Materials and methods


A total of 40 extracted permanent molars with occlusal caries were selected for this study. These teeth were split at the center of carious lesion buccolingually, in order to obtain two similar halves. Thus, 80 samples were obtained in this way and were randomly divided into 2 groups of 40 samples each. Caries was removed using conventional burs in group I and polymer bur Smartprep (SS white) in group II. The time involved in caries removal was measured for both the groups. After excavation of all carious lesions, the samples were decalcified, dehydrated, and embedded in paraffin wax from which thin sections of 5 μm were obtained, which were histologically evaluated for bacterial presence under a light microscope.
Results


An intergroup comparison between conventional bur (group I) and smart bur (group II) showed a statistically nonsignificant difference in terms of the presence of microorganisms after caries removal with a  p  value of 0.073638 ( p  > 0.05). However, the time taken for caries removal was significantly more for smart burs than diamond burs with a  p  value of 0.001 ( p  < 0.05).
Conclusion


The polymer burs were found to be as effective as the conventional burs in terms of microbial presence after caries removal, but are more time-consuming than conventional burs.
How to cite this article


Somani R, Chaudhary R, Jaidka S,  et al.  Comparative Microbiological Evaluation after Caries Removal by Various Burs. Int J Clin Pediatr Dent 2019;12(6):524-527.",2019,"Conclusion


The polymer burs were found to be as effective as the conventional burs in terms of microbial presence after caries removal, but are more time-consuming than conventional burs.
",['40 extracted permanent molars with occlusal caries'],[],"['time taken for caries removal', 'time involved in caries removal', 'caries removal efficacy', 'presence of microorganisms after caries removal']","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",40.0,0.0157617,"Conclusion


The polymer burs were found to be as effective as the conventional burs in terms of microbial presence after caries removal, but are more time-consuming than conventional burs.
","[{'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Somani', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DJ College of Dental Sciences and Research, Modinagar, Uttar Pradesh, India.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Chaudhary', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DJ College of Dental Sciences and Research, Modinagar, Uttar Pradesh, India.'}, {'ForeName': 'Shipra', 'Initials': 'S', 'LastName': 'Jaidka', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DJ College of Dental Sciences and Research, Modinagar, Uttar Pradesh, India.'}, {'ForeName': 'Deepti J', 'Initials': 'DJ', 'LastName': 'Singh', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DJ College of Dental Sciences and Research, Modinagar, Uttar Pradesh, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1678']
2990,31030626,Influencing Factors of Pre-Exposure Prophylaxis Self-Efficacy Among Men Who Have Sex With Men.,"This research examines the level of pre-exposure prophylaxis (PrEP) self-efficacy among HIV-negative men who have sex with men (MSM) in China and identifies the influencing factors associated with the level of PrEP self-efficacy in terms of social-demographic characteristics and social psychological factors. The data were gathered from a baseline assessment of a longitudinal randomized controlled intervention trial. From April 2013 to March 2015, nonprobability sampling was used to recruit HIV-negative MSM at Chongqing, Guangxi, Xinjiang, and Sichuan in west China. A total of 1884 HIV-negative MSM were analyzed. Chi-square test and nonparametric rank sum test were used for univariate analysis. Multivariable linear regression analysis was used to discuss the factors that influence the level of PrEP self-efficacy. Overall levels of PrEP self-efficacy were low, and five factors were found to effect PrEP self-efficacy: age, residence, AIDS-related knowledge, PrEP-related motivation, and anxiety. Age and anxiety score were negatively related to PrEP self-efficacy. The higher the age and anxiety score, the lower the PrEP self-efficacy. AIDS-related knowledge and PrEP-related motivation were actively related to PrEP self-efficacy. The higher the knowledge and motivation score, the higher the PrEP self-efficacy. In addition, the PrEP self-efficacy level of MSM in rural areas is lower than that in urban areas. The lower level of self-efficacy in the MSM population needs to be improved. Pertinent interventions should be taken to promote the self-efficacy of PrEP in MSM, to enhance their willingness to take medicine, improve their medication adherence, and thus reduce HIV infection among MSM.",2019,"The higher the knowledge and motivation score, the higher the PrEP self-efficacy.","['Who Have Sex With Men', 'A total of 1884 HIV-negative MSM', 'HIV-negative men who have sex with men (MSM) in China', 'Men']",[],"['Overall levels of PrEP self-efficacy', 'knowledge and motivation score', 'Age and anxiety score', 'lower level of self-efficacy', 'effect PrEP self-efficacy: age, residence, AIDS-related knowledge, PrEP-related motivation, and anxiety', 'age and anxiety score']","[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",1884.0,0.0238922,"The higher the knowledge and motivation score, the higher the PrEP self-efficacy.","[{'ForeName': 'Dou', 'Initials': 'D', 'LastName': 'Qu', 'Affiliation': '1 Department of Epidemiology and Health Statistics, School of Public Health and Management, Chongqing Medical University, China.'}, {'ForeName': 'Xiaoni', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': '1 Department of Epidemiology and Health Statistics, School of Public Health and Management, Chongqing Medical University, China.'}, {'ForeName': 'Minqing', 'Initials': 'M', 'LastName': 'Lai', 'Affiliation': '1 Department of Epidemiology and Health Statistics, School of Public Health and Management, Chongqing Medical University, China.'}, {'ForeName': 'Jianghong', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': '4 Department of Epidemiology and Health Statistics, School of Public Health, Xinjiang Medical University, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': '5 Department of Epidemiology and Health Statistics, School of Public Health, Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Ailong', 'Initials': 'A', 'LastName': 'Huang', 'Affiliation': '6 Key Laboratory of Molecular Biology, Ministry of Molecular Biology, Infectious Diseases, Medical University of Chongqing, China.'}]",American journal of men's health,['10.1177/1557988319847088']
2991,32440066,"Effect of Herbal Water, Ozonated Water, Water, and Chlorhexidine Mouthrinses on Oral Health Status of Children: A Randomized Controlled Trial.","Aim


To evaluate the antibacterial effect of herbal water, ozonated water, and chlorhexidine mouthrinses on salivary  Streptococcus mutans  level and to assess their effectiveness of these mouthrinses on the oral health status of children.
Materials and methods


A parallel multiarm randomized controlled trial was conducted in 100 children aged 10-12 years. Debris index-simplified (DI-S), calculus index-simplified (CI-S), oral hygiene index-simplified (OHI-S) scores, and  Streptococcus mutans  counts were recorded at baseline ( T   1 ). They were randomly divided into four equal groups ( n  = 25): HW, herbal water; OW, ozonated water; W, water; and CHX, chlorhexidine. Intervention period was 15 days and data collection was repeated after 15 days ( T   2 ) and 30 days ( T   3 ). Saliva samples were used to evaluate  S. mutans  count. Results were tabulated and analyzed statistically.
Results


OW had minimum DI-S score at  T   2  and  T   3  periods. HW had the minimum CI-S score at  T   2  and  T   3  periods. CHX had the minimum  S. mutans  count at  T   2  and  T   3  periods. OW showed maximum reduction in OHI-S score at  T   2  period. HW showed maximum reduction in OHI-S score at  T   3  period.
Conclusion


Herbal water and ozone water can be used as an alternative to chlorhexidine in maintaining the oral health status.
Clinical significance


Herbal water and ozonated water can be used in children instead of chemical mouthrinses to avoid any adverse effects.
How to cite this article


Mon J, Asokan S, Priya PRG,  et al.  Effect of Herbal Water, Ozonated Water, Water, and Chlorhexidine Mouthrinses on Oral Health Status of Children: A Randomized Controlled Trial. Int J Clin Pediatr Dent 2019;12(6):514-519.",2019,"HW showed maximum reduction in OHI-S score at  T   3  period.
","['100 children aged 10-12 years', 'Children', 'Streptococcus mutans', 'children']","['Herbal Water, Ozonated Water, Water, and Chlorhexidine Mouthrinses', 'HW, herbal water; OW, ozonated water; W, water; and CHX, chlorhexidine', 'herbal water, ozonated water, and chlorhexidine mouthrinses', 'chlorhexidine']","['minimum DI-S score', 'minimum CI-S score', 'OHI-S score', 'Debris index-simplified (DI-S), calculus index-simplified (CI-S), oral hygiene index-simplified (OHI-S) scores, and']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0029165', 'cui_str': 'Oral Hygiene Indexes'}]",100.0,0.0605497,"HW showed maximum reduction in OHI-S score at  T   3  period.
","[{'ForeName': 'Jijo', 'Initials': 'J', 'LastName': 'Mon', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, India.'}, {'ForeName': 'Sharath', 'Initials': 'S', 'LastName': 'Asokan', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, India.'}, {'ForeName': 'Pollachi Rg', 'Initials': 'PR', 'LastName': 'Priya', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, India.'}, {'ForeName': 'Thoppe Dy', 'Initials': 'TD', 'LastName': 'Kumar', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, KSR Institute of Dental Science and Research, Tiruchengode, Tamil Nadu, India.'}, {'ForeName': 'Mythili G', 'Initials': 'MG', 'LastName': 'Balasubramaniam', 'Affiliation': 'Department of Biotechnology, KS Rangasamy College of Technology, Tiruchengode, Tamil Nadu, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1693']
2992,32440060,Nanosilver Fluoride-A Paradigm Shift for Arrest in Dental Caries in Primary Teeth of Schoolchildren: A Randomized Controlled Clinical Trial.,"Background


Due to limited financial resources, poor access to basic oral care, and the high cost of restorative treatment, children of low-income nations have their general health, social well-being, and education opportunities affected by untreated dental caries. Arresting caries treatment (ACT) has been proposed to manage untreated dental caries in children of disadvantaged communities.
Aims and objectives


The purpose of the present controlled clinical trial is to investigate the effectiveness of a new anticaries agent, nanosilver fluoride (NSF), preventing and arresting caries in children.
Materials and methods


A total of 100 deciduous molars both maxillary and mandibular are randomly selected from 60 children of 4-9 years of age group, which were randomly divided into NSF experimental group and saline control group. Teeth were clinically diagnosed and treated by one masked examiner and followed up at 7 days, 5 months and 12 months by another calibrated examiner who was blinded to the type of treatment. The criteria of the ICDAS II were followed to determine the activity of lesion and the diagnosis of caries. The Pearson's Chi-square test was used to compare the groups during different follow-up examinations.
Results


Seventy-eight percent of decayed teeth showed hard arrested dentine at 7 days; after 5-month analysis in the NSF group, 72.91% of the teeth showed arrested caries; and in the control group, only 34% of teeth showed arrest of caries. At 12-month analysis in the NSF group, 65.21% of teeth showed arrested cavities, and in the control group, 28.88% of teeth showed arrest of caries.
Conclusion


The present study proves that NSF is an anticaries agent and presents a noninvasive option for caries arrest and treatment when applied directly to dentin caries lesions.
How to cite this article


Nagireddy VR, Reddy D, Kondamadugu S,  et al.  Nanosilver Fluoride-A Paradigm Shift for Arrest in Dental Caries in Primary Teeth of Schoolchildren: A Randomized Controlled Clinical Trial. Int J Clin Pediatr Dent 2019;12(6):484-490.",2019,"At 12-month analysis in the NSF group, 65.21% of teeth showed arrested cavities, and in the control group, 28.88% of teeth showed arrest of caries.
","['children of disadvantaged communities', 'Dental Caries in Primary Teeth of Schoolchildren', '100 deciduous molars both maxillary and mandibular are randomly selected from 60 children of 4-9 years of age group', 'children']","['Nanosilver Fluoride-A Paradigm Shift', 'NSF', 'new anticaries agent, nanosilver fluoride (NSF', 'NSF experimental group and saline control group']","['arrest of caries', 'arrested caries']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0772313', 'cui_str': 'colloidal silver'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0266848', 'cui_str': 'Arrested dental caries'}]",,0.0528208,"At 12-month analysis in the NSF group, 65.21% of teeth showed arrested cavities, and in the control group, 28.88% of teeth showed arrest of caries.
","[{'ForeName': 'Venugopal R', 'Initials': 'VR', 'LastName': 'Nagireddy', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Mamata Dental College and Hospital, Khammam, Telangana, India.'}, {'ForeName': 'Daneswari', 'Initials': 'D', 'LastName': 'Reddy', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Mamata Dental College and Hospital, Khammam, Telangana, India.'}, {'ForeName': 'Saigeeta', 'Initials': 'S', 'LastName': 'Kondamadugu', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Mamata Dental College and Hospital, Khammam, Telangana, India.'}, {'ForeName': 'Niharika', 'Initials': 'N', 'LastName': 'Puppala', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Mamata Dental College and Hospital, Khammam, Telangana, India.'}, {'ForeName': 'Ajayreddy', 'Initials': 'A', 'LastName': 'Mareddy', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Mamata Dental College and Hospital, Khammam, Telangana, India.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Chris', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Mamata Dental College and Hospital, Khammam, Telangana, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1703']
2993,32440004,Arm-pull thrust in human swimming and the effect of post-activation potentiation.,"The aim of this study was to analyse the front-crawl arm-pull kinetics and kinematics, comparing it before and after post-activation potentiation (PAP), and the associations between variables describing of the arm-pull kinetics. Twelve male competitive swimmers were randomly assigned to perform two different warm-ups in a crossover manner: (i) non-PAP (control condition); and (ii) PAP (experimental condition). PAP consisted of 2 × 5 arm-pulls with resistance bands by both upper-limbs. Eight minutes later, participants underwent a 25 m all-out trial in front-crawl arm-pull. Kinetics (i.e., peak thrust, mean thrust and thrust-time integral) and kinematics (i.e., speed and speed fluctuation) were collected by an in-house customised system composed of differential pressure sensors, speedo-meter and underwater camera. There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74). There were non-significant and small effects of PAP on speed (P = 0.307, d = 0.18) and speed fluctuation (P = 0.498, d = 0.04). Correlation coefficients among kinetic variables were significant with large associations (0.51 < R < 0.90, 0.001 < P < 0.088). In conclusion, warm-ups including PAP conditioning sets elicit a large improvement in the thrust, but with small improvement in performance. Variables used to characterise thrust are strongly correlated and hence can be used interchangeably.",2020,"There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74).",['Twelve male competitive swimmers'],['crossover manner: (i) non-PAP (control condition); and (ii) PAP (experimental condition'],"['Kinetics (i.e., peak thrust, mean thrust and thrust-time integral) and kinematics (i.e., speed and speed fluctuation', 'arm-pull kinetics', 'speed fluctuation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}]","[{'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}]",12.0,0.0288481,"There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74).","[{'ForeName': 'Tiago M', 'Initials': 'TM', 'LastName': 'Barbosa', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore. tiago.barbosa@nie.edu.sg.'}, {'ForeName': 'Jia Wen', 'Initials': 'JW', 'LastName': 'Yam', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Lum', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Govindasamy', 'Initials': 'G', 'LastName': 'Balasekaran', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Marinho', 'Affiliation': 'Research Centre in Sports, Health and Human Development - CIDESD, Vila Real, Portugal.'}]",Scientific reports,['10.1038/s41598-020-65494-z']
2994,32440086,Short-Term Efficacy and Safety of Switching from a Latanoprost/Timolol Fixed Combination to a Latanoprost/Carteolol Fixed Combination.,"Purpose


To investigate the short-term intraocular pressure-lowering efficacy and safety of switching from a fixed combination of latanoprost/timolol to a fixed combination of latanoprost/carteolol.
Patients and Methods


The subjects were 30 eyes of 30 adult patients with primary open-angle glaucoma, normal-tension glaucoma, or ocular hypertension who were using a latanoprost-/timolol-fixed combination with insufficient intraocular pressure-lowering efficacy or adverse reactions. The subjects were switched from once-daily latanoprost/timolol to once-daily latanoprost/carteolol with no washout interval. Intraocular pressure, tear film break-up time, corneal epithelial defects, conjunctival hyperemia, blood pressure, and pulse rate were measured and compared before and 1 and 3 months after switching. Patients were monitored for adverse reactions at each visit, and dropouts were recorded.
Results


The mean intraocular pressure at 1 month (15.9±3.1 mmHg) and 3 months (16.3±3.8 mmHg) was not significantly different from that at baseline (16.1±3.1 mmHg). The tear film break-up time and corneal epithelial defects were significantly improved after switching (p<0.01 and p<0.0001, respectively). There was a significant decrease in systolic blood pressure after 1 month and diastolic pressure after 3 months (p<0.05). There was no significant change in pulse rate during the study. Adverse reactions (blurred vision, blepharitis, and conjunctival hyperemia) occurred in 3 patients (10.0%). Four patients (13.3%) discontinued treatment during the 3-month study period.
Conclusion


A switch from a fixed combination of latanoprost/timolol to that of latanoprost/carteolol can maintain intraocular pressure and adherence with once-daily administration while improving tear film break-up time and corneal epithelial defects.",2020,"The tear film break-up time and corneal epithelial defects were significantly improved after switching (p<0.01 and p<0.0001, respectively).","['subjects were 30 eyes of 30 adult patients with primary open-angle glaucoma, normal-tension glaucoma, or ocular hypertension who were using a latanoprost-/timolol-fixed combination with insufficient intraocular pressure-lowering efficacy or adverse reactions']","['latanoprost/timolol', 'Latanoprost/Carteolol Fixed Combination', 'Latanoprost/Timolol', 'latanoprost/carteolol']","['mean intraocular pressure', 'Intraocular pressure, tear film break-up time, corneal epithelial defects, conjunctival hyperemia, blood pressure, and pulse rate', 'diastolic pressure', 'pulse rate', 'tear film break-up time and corneal epithelial defects', 'adverse reactions', 'systolic blood pressure', 'intraocular pressure and adherence', 'Adverse reactions (blurred vision, blepharitis, and conjunctival hyperemia']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0152136', 'cui_str': 'Low tension glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]","[{'cui': 'C1271556', 'cui_str': 'Latanoprost- and timolol-containing product'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0007299', 'cui_str': 'Carteolol'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C1299691', 'cui_str': 'Corneal epithelial defect'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}]",30.0,0.0652169,"The tear film break-up time and corneal epithelial defects were significantly improved after switching (p<0.01 and p<0.0001, respectively).","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Inouye Eye Hospital, Tokyo, Japan.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Piao', 'Affiliation': 'Inouye Eye Hospital, Tokyo, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Iwasa', 'Affiliation': 'Inouye Eye Hospital, Tokyo, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'Department of Ophthalmology, Toho University Ohashi Medical Center, Tokyo, Japan.'}, {'ForeName': 'Goji', 'Initials': 'G', 'LastName': 'Tomita', 'Affiliation': 'Department of Ophthalmology, Toho University Ohashi Medical Center, Tokyo, Japan.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S240425']
2995,32440039,"Comparative Analysis of CPP-ACP, Tricalcium Phosphate, and Hydroxyapatite on Assessment of Dentinal Tubule Occlusion on Primary Enamel Using SEM: An  In Vitro  Study.","Background


Over the last few decades, fluoride in various forms has been proved to reduce caries and dentinal hypersensitivity in both the primary and permanent dentitions. Recently, newer materials containing calcium and phosphate ions, tricalcium phosphate, and hydroxyapatite has received much attention.
Aim


The aim of the study was to compare CPP-ACP, tricalcium phosphate, and hydroxyapatite in relation to the assessment of dentine tubule occlusion on primary enamel using scanning electron microscope (SEM).
Materials and methods


Forty freshly extracted noncarious primary molars were randomly divided into 4 groups (I-IV) with 10 sections in each group-group I: negative control, group II: CPP-ACP, group III: tricalcium phosphate, group IV: hydroxyapatite. To assess tubule occlusion, twenty dentin sections of 2-mm thickness were obtained from the cervical third of sound primary molars. Each section was processed to simulate the hypersensitive dentin and the test agents were brushed over the sections with an electric toothbrush and observed under a SEM for calculation of the percentage of occluded tubules.
Results


Groups II and IV showed a greater percentage of tubule occlusion than group III. An intergroup comparison of tubule occlusion potential of groups II and IV was not significant.
Conclusion


Hydroxyapatite showed significantly higher dentinal tubule occlusion when compared to CPP-ACP and tricalcium phosphate.
How to cite this article


Shah R, Bajaj M. Comparative Analysis of CPP-ACP, Tricalcium Phosphate, and Hydroxyapatite on Assessment of Dentinal Tubule Occlusion on Primary Enamel Using SEM: An  In Vitro  Study. Int J Clin Pediatr Dent 2019;12(5):371-374.",2019,"Conclusion


Hydroxyapatite showed significantly higher dentinal tubule occlusion when compared to CPP-ACP and tricalcium phosphate.
","['Materials and methods\n\n\nForty freshly extracted noncarious primary molars', 'Primary Enamel Using SEM']","['CPP-ACP, group III: tricalcium phosphate, group IV: hydroxyapatite', 'CPP-ACP, Tricalcium Phosphate, and Hydroxyapatite', 'Hydroxyapatite']","['percentage of tubule occlusion', 'dentinal tubule occlusion', 'caries and dentinal hypersensitivity']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181845', 'cui_str': 'Electron microscope'}]","[{'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0108136', 'cui_str': 'tricalcium phosphate'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0227017', 'cui_str': 'Dentinal tubules'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",40.0,0.0141091,"Conclusion


Hydroxyapatite showed significantly higher dentinal tubule occlusion when compared to CPP-ACP and tricalcium phosphate.
","[{'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Bharti Vidyapeeth Deemed University, Dental College and Hospital, Pune, Maharashtra, India.'}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Bajaj', 'Affiliation': 'Private Practice, Meghna Dental Care, Navi Mumbai, Maharashtra, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1680']
2996,32440042,Plaque Removal Efficacy of Different Toothbrushes: A Comparative Study.,"Aim and objective


This study aimed to compare the plaque removal efficacy of different toothbrushes and to ascertain the most efficient mechanical mean for daily plaque removal so as to maintain oral health in a preeminent way.
Study design


It was a randomized controlled clinical trial consisting of 60 subjects divided into three groups (group I ultrasonic and sonic toothbrush, group II multidirectional toothbrush, and group III manual toothbrush) with 20 in each group. Prebrushing and postbrushing plaque scores were recorded at weekly intervals for four weeks using Turesky modification of Quigley and Hein plaque index.
Results


Statistically significant differences ( p  < 0.001) existed in mean percent reduction of pre-day 1 to pre-day 28 mean percent reduction in plaque values of the ultrasonic toothbrush group (111.92 ± 25.20), the multidirectional toothbrush group (189.06 ± 52.70), and the manual toothbrush group (42.34 ± 14.77). Similar results were found in post-day 1 to post-day 28 mean percent reduction in plaque values.
Conclusion


Group II (i.e., multidirectional toothbrush) showed maximum mean percent reduction in prebrushing and postbrushing plaque scores at the end of four weeks when compared with the baseline values followed by ultrasonic toothbrush and manual toothbrush.
How to cite this article


Aggarwal N, Gupta S, Grover R,  et al.  Plaque Removal Efficacy of Different Toothbrushes: A Comparative Study. Int J Clin Pediatr Dent 2019;12(5):385-390.",2019,"Statistically significant differences ( p  < 0.001) existed in mean percent reduction of pre-day 1 to pre-day 28 mean percent reduction in plaque values of the ultrasonic toothbrush group (111.92 ± 25.20), the multidirectional toothbrush group (189.06 ± 52.70), and the manual toothbrush group (42.34 ± 14.77).",['60 subjects divided into three groups (group I'],"['ultrasonic and sonic toothbrush, group II multidirectional toothbrush, and group III manual toothbrush', 'Different Toothbrushes']","['Plaque Removal Efficacy', 'plaque values', 'maximum mean percent reduction in prebrushing and postbrushing plaque scores', 'Prebrushing and postbrushing plaque scores']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441843', 'cui_str': 'Group I'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0291,"Statistically significant differences ( p  < 0.001) existed in mean percent reduction of pre-day 1 to pre-day 28 mean percent reduction in plaque values of the ultrasonic toothbrush group (111.92 ± 25.20), the multidirectional toothbrush group (189.06 ± 52.70), and the manual toothbrush group (42.34 ± 14.77).","[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Sri Guru Ram Das Institute of Dental Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Sri Guru Ram Das Institute of Dental Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Rashu', 'Initials': 'R', 'LastName': 'Grover', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Sri Guru Ram Das Institute of Dental Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Gunmeen', 'Initials': 'G', 'LastName': 'Sadana', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Sri Guru Ram Das Institute of Dental Sciences and Research, Amritsar, Punjab, India.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Bansal', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Adesh Institute of Dental Sciences and Research, Bathinda, Punjab, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1669']
2997,32440064,Eye Movement Distraction: A New Distraction Technique for Management of Dental Anxiety during Intraoral Local Anesthesia Administration in Children.,"Background


To evaluate the efficacy of eye movement distraction (EMD) in reducing anxiety during intraoral local anesthetic administration in needle-phobic children.
Materials and methods


A total of 228 children aged 8-13 years were divided into two groups: group I (EMD) and group II (control), and subjective feelings of each child were recorded with a faces pain scale-revised (FPS-R) score. Both the groups (I and II) were compared using the Chi-square test.
Results


Children in the EMD group showed low FPS-R scores, which is statistically significant when compared to the control group ( p  < 0.0001).
Conclusion


Eye movement distraction can be used as an effective distraction modality to reduce anxiety during local anesthesia administration in needle-phobic children.
How to cite this article


Tirupathi S, Krishna N, Rajasekhar S,  et al.  Eye Movement Distraction: A New Distraction Technique for Management of Dental Anxiety during Intraoral Local Anesthesia Administration in Children. Int J Clin Pediatr Dent 2019;12(6):507-509.",2019,"Children in the EMD group showed low FPS-R scores, which is statistically significant when compared to the control group ( p  < 0.0001).
","['228 children aged 8-13 years', 'Children', 'needle-phobic children']","['eye movement distraction (EMD', 'Eye Movement Distraction']","['faces pain scale-revised (FPS-R) score', 'low FPS-R scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}]","[{'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",228.0,0.0181991,"Children in the EMD group showed low FPS-R scores, which is statistically significant when compared to the control group ( p  < 0.0001).
","[{'ForeName': 'Sunnypriyatham', 'Initials': 'S', 'LastName': 'Tirupathi', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India.'}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Krishna', 'Affiliation': 'Department of Pedodontics, Narayana Dental College, Nellore, Andhra Pradesh, India.'}, {'ForeName': 'Srinitya', 'Initials': 'S', 'LastName': 'Rajasekhar', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Narayana Dental College and Hospital, Nellore, Andhra Pradesh, India.'}, {'ForeName': 'Sivakumar', 'Initials': 'S', 'LastName': 'Nuvvula', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Narayana Dental College and Hospital, Nellore, Andhra Pradesh, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1690']
2998,32439957,A randomized trial of intravenous acetaminophen versus indomethacin for treatment of hemodynamically significant PDAs in VLBW infants.,"Objective was to compare the rate of successful treatment of hsPDA based on echocardiogram criteria after use of IV acetaminophen or IV indomethacin in very low-birthweight infants. The study was a multi-center, randomized controlled trial. Infants born prior to 32 weeks with birthweight ≤ 1500 g were included if PDA treatment was indicated within the 21 days after birth. hsPDA was defined by strict echocardiogram criteria. Eligible infants were randomized to treatment with either IV acetaminophen or IV indomethacin. Of 86 eligible infants, 17 infants were randomized to acetaminophen and 20 to indomethacin. One (5.9%) hsPDA in the acetaminophen group had successful treatment compared to 11 (55%) in the indomethacin group (p = 0.002). Eight (47%) in the acetaminophen group and 3 (15%) in the indomethacin group received transcatheter PDA closure (p = 0.07). IV indomethacin was more effective than IV acetaminophen for treatment of hsPDAs. More infants in the acetaminophen group received transcatheter closure.",2020,hsPDA in the acetaminophen group had successful treatment compared to 11 (55%) in the indomethacin group (p = 0.002).,"['Eligible infants', 'very low-birthweight infants', 'Infants born prior to 32 weeks with birthweight ≤\u20091500\u2009g were included if', '86 eligible infants, 17 infants', 'VLBW infants']","['indomethacin', 'IV acetaminophen or IV indomethacin', 'IV indomethacin', 'PDA', 'transcatheter closure', 'acetaminophen', 'acetaminophen or IV indomethacin']","['transcatheter PDA closure', 'hsPDA']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",17.0,0.0650303,hsPDA in the acetaminophen group had successful treatment compared to 11 (55%) in the indomethacin group (p = 0.002).,"[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Davidson', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, TN, USA. jhendr20@uthsc.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ferguson', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ivey', 'Affiliation': 'Mednax/Germantown Hospital, Germantown, TN, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Philip', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Weems', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Talati', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, TN, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0694-1']
2999,32440048,Effectiveness of Cognitive Behavioral Play Therapy and Audiovisual Distraction for Management of Preoperative Anxiety in Children.,"Background


Children with high level of preoperative anxiety during their visit to dental office are more likely to develop maladaptive behavior postoperatively. First dental experience is always critical in molding child's attitude toward dentistry. Various behavior management methods are being employed during dental treatment to complete anticipated treatment in children.
Aim


The aim of the study was to evaluate the effectiveness of cognitive behavioral play therapy and audiovisual distraction for management of preoperative anxiety in children.
Materials and methods


A total of 45 children of age 6-10 years with moderate-to-severe anxiety were allocated into three groups: group I-cognitive behavioral play therapy (CBT), group II-audiovisual (AV) distraction, and group III-tell-show-do technique (control group). Children in the CBT group were allowed to play with building blocks, asked to draw a picture and then showed a modeling video of co-operative child undergoing dental treatment. Children in group II were subjected to passive distraction with audiovisual aids, whereas group III (control) children were managed with the conventional TSD technique. Baseline and postintervention objective and subjective anxiety scores were measured with a pulse oximeter and facial image scale (FIS), respectively.
Results


A statistically significant reduction in the subjective and objective anxiety scores is observed in all the three groups ( p  = 0.001) in both intragroup and intergroup comparisons. On intergroup comparison, the reduction in subjective and objective anxiety scores was higher in CBT ( p  = 0.0) than in AV distraction and TSD groups ( p  = 0.05).
Conclusion


Active distraction with cognitive behavioral play therapy is found to be more effective in reducing the preoperative anxiety in children compared to audiovisual distraction and tell-show-do technique.
Clinical significance


Identification and management of preoperative anxiety in children is most critical for successful dental treatment. Active distraction is an effective psychological approach for behavior management in anxious children.
How to cite this article


Rajeswari SR, Chandrasekhar R, Vinay C,  et al.  Effectiveness of Cognitive Behavioral Play Therapy and Audiovisual Distraction for Management of Preoperative Anxiety in Children. Int J Clin Pediatr Dent 2019;12(5):419-422.",2019,"On intergroup comparison, the reduction in subjective and objective anxiety scores was higher in CBT ( p  = 0.0) than in AV distraction and TSD groups ( p  = 0.05).
","['45 children of age 6-10 years with moderate-to-severe anxiety', 'Children', 'anxious children', 'children']","['conventional TSD technique', 'cognitive behavioral play therapy (CBT), group II-audiovisual (AV) distraction, and group III-tell-show-do technique (control group', 'cognitive behavioral play therapy and audiovisual distraction', 'cognitive behavioral play therapy', 'Cognitive Behavioral Play Therapy and Audiovisual Distraction', 'Active distraction', 'passive distraction with audiovisual aids']","['subjective and objective anxiety scores', 'Baseline and postintervention objective and subjective anxiety scores', 'preoperative anxiety', 'reduction in subjective and objective anxiety scores', 'pulse oximeter and facial image scale (FIS), respectively']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039373', 'cui_str': 'Tay-Sachs disease'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032216', 'cui_str': 'Play therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0004282', 'cui_str': 'Audio-Visual Aids'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",45.0,0.0196022,"On intergroup comparison, the reduction in subjective and objective anxiety scores was higher in CBT ( p  = 0.0) than in AV distraction and TSD groups ( p  = 0.05).
","[{'ForeName': 'Sandaka Raja', 'Initials': 'SR', 'LastName': 'Rajeswari', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'Rayala', 'Initials': 'R', 'LastName': 'Chandrasekhar', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vinay', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Uloopi', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'Kakarla Sri', 'Initials': 'KS', 'LastName': 'RojaRamya', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}, {'ForeName': 'Manumanthu Venkata', 'Initials': 'MV', 'LastName': 'Ramesh', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1661']
3000,32440093,Inter-Ocular Symmetry of Vascular Density and Retinal Thickness in Unilateral Anisometropic Amblyopia.,"Background


Inter-ocular symmetry of macular vascular anatomy in healthy subjects has been well documented in previous optical coherence tomography angiography (OCTA) studies. In our present study, we have demonstrated that the presence of anisometropic amblyopia in one eye does not alter this unique feature significantly. We investigated whether the presence of unilateral anisometropic amblyopia due to moderate amounts of hyperopia and/or astigmatism would have any significant influence on measurements of retinal thickness (RT) and superficial vessel density (SVD) in adult subjects.
Subjects and methods


In the study group, both eyes of 21 adult subjects with unilateral anisometropic amblyopia were enrolled. Only one eye of an age-matched control group including 33 subjects was randomly selected. RT and SVD were measured in foveal and parafoveal retinal areas and compared in amblyopic eyes, their fellow eyes and in the control group. Inter-ocular symmetry of RT and SVD in amblyopic and fellow eyes were investigated by using correlation analysis.
Results


There were statistically significant inter-ocular correlations of foveal and parafoveal RT in amblyopic and fellow eyes ( P  < 0.0001, for both). Foveal and parafoveal RT of the control group were not statistically different from amblyopic eyes ( P  = 0.072 and  P  = 0.46, respectively). There was no difference between foveal SVD of amblyopic eyes and control group ( P  = 0.10) and a significant inter-ocular correlation was found between amblyopic and fellow eyes ( P  = 0.029).
Conclusion


For our adult subjects, none of the investigated OCTA parameters of the amblyopic eyes were found to be statistically different from those of age-matched controls. The preservation of inter-ocular symmetry in the amblyopic and fellow eyes implies that the influence of anisometropic amblyopia in one eye would be relatively small and negligible on routine OCTA examination.",2020,"There was no difference between foveal SVD of amblyopic eyes and control group ( P  = 0.10) and a significant inter-ocular correlation was found between amblyopic and fellow eyes ( P  = 0.029).
","['Only one eye of an age-matched control group including 33 subjects was randomly selected', '21 adult subjects with unilateral anisometropic amblyopia were enrolled', 'adult subjects', 'healthy subjects', 'Unilateral Anisometropic Amblyopia', 'Subjects and methods']",['\n\n\nInter-ocular symmetry'],"['retinal thickness (RT) and superficial vessel density (SVD', 'RT and SVD', 'foveal SVD of amblyopic eyes', 'Foveal and parafoveal RT', 'ocular correlations of foveal and parafoveal RT in amblyopic and fellow eyes']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0339696', 'cui_str': 'Anisometropic amblyopia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}]","[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0442137', 'cui_str': 'Parafoveal'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",21.0,0.0226238,"There was no difference between foveal SVD of amblyopic eyes and control group ( P  = 0.10) and a significant inter-ocular correlation was found between amblyopic and fellow eyes ( P  = 0.029).
","[{'ForeName': 'Zerrin', 'Initials': 'Z', 'LastName': 'Bayraktar', 'Affiliation': 'Department of Ophthalmology, Ozel Gaziosmanpasa Hospital, Yeni Yuzyil University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Seren', 'Initials': 'S', 'LastName': 'Pehlivanoglu', 'Affiliation': 'Department of Ophthalmology, Ozel Gaziosmanpasa Hospital, Yeni Yuzyil University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Sukru', 'Initials': 'S', 'LastName': 'Bayraktar', 'Affiliation': 'Department of Ophthalmology, Ozel Gaziosmanpasa Hospital, Yeni Yuzyil University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Albayrak', 'Affiliation': 'Department of Ophthalmology, Ozel Gaziosmanpasa Hospital, Yeni Yuzyil University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Muharrem', 'Initials': 'M', 'LastName': 'Karakaya', 'Affiliation': 'Department of Ophthalmology, Ozel Gaziosmanpasa Hospital, Yeni Yuzyil University School of Medicine, Istanbul, Turkey.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S234294']
3001,32440101,Dupilumab: Clinical Efficacy of Blocking IL-4/IL-13 Signalling in Chronic Rhinosinusitis with Nasal Polyps.,"In September 2019,  The Lancet  published details of two large Phase III double-blind placebo-controlled studies (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52) confirming the clinical efficacy of the biologic dupilumab in simultaneously blocking both IL-4/IL-13 signalling in chronic rhinosinusitis with nasal polyps (CRSwNP). The studies demonstrated that dupilumab (Dupixent ® , Sanofi and Regeneron) 300mg subcutaneously administered was clinically effective when added for patients with moderate to severe CRSwNP already maintained on the standard intranasal steroid mometasone furoate. Duration of treatment ranged from injections either 2 weekly for 24 weeks (SINUS-24) or every 2 weeks for 52 weeks or finally every 2 weeks for 24 weeks stepping down thereafter to every 4 weeks for a further 28 weeks (SINUS-52). Rapid improvements in all important parameters of disease burden were seen with such improvement maintained even where the frequency of injections was decreased. In patients with co-existent asthma, lung function and asthma control scores improved. This is consistent with the one airway hypothesis of shared T2 inflammatory programmes driving both disease syndromes. The studies formed the basis for FDA registration and clinical launch in the US, and EMA approval in Europe. Dupilumab presents a significant new treatment option in an area of urgent unmet therapeutic need in CRSwNP. Should dupilumab prove to be as effective in the real-life clinical environment as it has been in the studies, then a paradigm shift from sinonasal surgery to medical treatment of CRSwNP may need to occur in the ENT community. Questions in relation to best patient selection, combined upper and lower airway therapeutic pathways, long-term safety along with health economics and cost constraints ought now to be addressed.",2020,Rapid improvements in all important parameters of disease burden were seen with such improvement maintained even where the frequency of injections was decreased.,"['Chronic Rhinosinusitis with Nasal Polyps', 'chronic rhinosinusitis with nasal polyps (CRSwNP']","['Blocking IL-4/IL-13 Signalling', 'dupilumab (Dupixent ® , Sanofi and Regeneron', 'standard intranasal steroid mometasone furoate']",['lung function and asthma control scores'],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C4325130', 'cui_str': 'Dupixent'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.017168,Rapid improvements in all important parameters of disease burden were seen with such improvement maintained even where the frequency of injections was decreased.,"[{'ForeName': 'Harsha H', 'Initials': 'HH', 'LastName': 'Kariyawasam', 'Affiliation': 'Department of Specialist Allergy and Clinical Immunology, Royal National ENT Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Louisa K', 'Initials': 'LK', 'LastName': 'James', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Gane', 'Affiliation': 'Department of Rhinology, Royal National ENT Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}]","Drug design, development and therapy",['10.2147/DDDT.S243053']
3002,32440098,Pharmacokinetic Evaluation by Modeling and Simulation Analysis of a Donepezil Patch Formulation in Healthy Male Volunteers.,"Introduction


This study characterized the pharmacokinetics (PKs) of a donepezil patch formulation currently under development, using mixed effect modeling analysis, and explored optimal patch dosing regimens in comparison with the donepezil oral formulation.
Methods


PK data used in this analysis were from 60 healthy Korean male subjects participating in two Phase I studies, where subjects received single or multiple doses of donepezil of 43.75, 87.5, and 175 mg via patches, and 12 of them received a single oral dose of 10 mg of donepezil, followed by a single dose of donepezil via a patch. Donepezil PKs were analyzed by nonlinear mixed effect modeling using NONMEM software.
Results


A well-stirred model with two-compartment distribution and delayed absorption was chosen as the best model for the oral formulation. The PKs of donepezil after the patch applications were best described by a two-compartment linear model with zero-order absorption (D2) and absorption delay. The relative bioavailability (BA) of donepezil after the patch application compared with oral dosing was described to be affected by the duration of patch application.
Conclusion


PK simulations based on the chosen PK models suggested that, overall, donepezil exposure in plasma is similar whether with 10 mg of oral donepezil every 24 h or a 175 mg patch every 72 h, and likewise with 5 mg of oral donepezil every 24 h or an 87.5 mg patch every 72 h.",2020,"The relative bioavailability (BA) of donepezil after the patch application compared with oral dosing was described to be affected by the duration of patch application.
","['Healthy Male Volunteers', '60 healthy Korean male subjects participating in two Phase']","['Donepezil', 'donepezil', 'Donepezil Patch Formulation', 'oral donepezil', 'donepezil patch formulation', 'donepezil oral formulation', 'donepezil via a patch']",['relative bioavailability (BA'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.0605022,"The relative bioavailability (BA) of donepezil after the patch application compared with oral dosing was described to be affected by the duration of patch application.
","[{'ForeName': 'Seok Kyu', 'Initials': 'SK', 'LastName': 'Yoon', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Kyun-Seop', 'Initials': 'KS', 'LastName': 'Bae', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Hyun', 'Initials': 'DH', 'LastName': 'Hong', 'Affiliation': 'Department of Pharmaceutical Research, iCure Pharmaceutical Incorporated, Seoul, Republic of Korea.'}, {'ForeName': 'Seong Su', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Department of Pharmaceutical Research, iCure Pharmaceutical Incorporated, Seoul, Republic of Korea.'}, {'ForeName': 'Young Kweon', 'Initials': 'YK', 'LastName': 'Choi', 'Affiliation': 'Department of Pharmaceutical Research, iCure Pharmaceutical Incorporated, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeong-Seok', 'Initials': 'HS', 'LastName': 'Lim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea.'}]","Drug design, development and therapy",['10.2147/DDDT.S244957']
3003,32440518,Cognitive behavioural therapy for insomnia reduces sleep apnoea severity: a randomised controlled trial.,"Insomnia and obstructive sleep apnoea (OSA) frequently co-occur and may be causally related through sleep fragmentation and/or hyperarousal mechanisms. Previous studies suggest that OSA treatment can improve insomnia severity. However, the effect of insomnia treatment on OSA severity has not been investigated. We performed a randomised controlled trial to investigate the effect of cognitive behavioural therapy for insomnia (CBTi) on OSA severity, controlling for potential sleep-stage and posture effects. 145 patients with comorbid insomnia (International Classification of Sleep Disorders, 3rd Edn) and untreated OSA (apnoea-hypopnoea index (AHI) ≥15 events·h -1  sleep) were randomised to a four-session CBTi programme or to a no-treatment control. Overnight sleep studies were completed pre- and post-treatment to measure AHI, arousal index and sleep architecture, to investigate the effect of intervention group, time, sleep stage (N1-3 or REM) and posture (supine or nonsupine) on OSA severity. The CBTi group showed a 7.5 event·h -1  greater AHI difference (mean (95% CI) decrease 5.5 (1.3-9.7) events·h -1 , Cohen's  d =0.2, from 36.4 events·h -1  pre-treatment) across sleep-stages and postures, compared to control (mean increase 2.0 (-2.0-6.1) events·h -1 ,  d =0.01, from 37.5 events·h -1  at pre-treatment; interaction p=0.012). Compared to control, the CBTi group also had a greater reduction in total number (mean difference 5.6 (0.6-10.6) greater overall reduction; p=0.029) and duration of nocturnal awakenings (mean difference 21.1 (2.0-40.3) min greater reduction; p=0.031) but showed no difference in the arousal index, or sleep architecture. CBTi consolidates sleep periods and promotes a 15% decrease in OSA severity in patients with comorbid insomnia and OSA. This suggests that insomnia disorder may exacerbate OSA and provides further support for treating insomnia in the presence of comorbid OSA.",2020,"Compared to control, the CBTi group also had a greater reduction in total number (mean difference 5.6 (0.6-10.6) greater overall reduction; p=0.029) and duration of nocturnal awakenings (mean difference 21.1 (2.0-40.3) min greater reduction; p=0.031) but showed no difference in the arousal index, or sleep architecture.","['145 patients with comorbid insomnia (International Classification of Sleep Disorders, 3rd Edn) and untreated OSA (apnoea-hypopnoea index (AHI) ≥15\u2005events·h -1  sleep', 'patients with comorbid insomnia and OSA']","['CBTi programme or to a no-treatment control', 'Cognitive behavioural therapy', 'cognitive behavioural therapy', 'OSA']","['OSA severity', 'insomnia severity', 'arousal index, or sleep architecture', 'Insomnia and obstructive sleep apnoea (OSA', 'sleep apnoea severity', 'total number', 'AHI, arousal index and sleep architecture', 'time, sleep stage (N1-3 or REM) and posture (supine or nonsupine) on OSA severity', 'duration of nocturnal awakenings']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0860510', 'cui_str': 'Nocturnal awakening'}]",145.0,0.0470048,"Compared to control, the CBTi group also had a greater reduction in total number (mean difference 5.6 (0.6-10.6) greater overall reduction; p=0.029) and duration of nocturnal awakenings (mean difference 21.1 (2.0-40.3) min greater reduction; p=0.031) but showed no difference in the arousal index, or sleep architecture.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sweetman', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Lack', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Antic', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Institute for Social Science Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Ching Li', 'Initials': 'CL', 'LastName': 'Chai-Coetzer', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Douglas', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': ""O'Grady"", 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dunn', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Denzil', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Eckert', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Catcheside', 'Affiliation': 'The Adelaide Institute for Sleep Health: a Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}]",ERJ open research,['10.1183/23120541.00161-2020']
3004,32440135,The Advantage of Implementation of Enhanced Recovery After Surgery (ERAS) in Acute Pain Management During Elective Cesarean Delivery: A Prospective Randomized Controlled Trial.,"Objective


The aim of this study was to test whether the implementation of an enhanced recovery after surgery (ERAS) protocol for patients undergoing elective cesarean delivery has a positive impact on the postoperative status of the patients in terms of pain management, hospital stay, hospitalization costs, and adverse reactions.
Methods


Patients who underwent elective cesarean delivery were randomized into two groups - ERAS group and control group - and the groups were managed with the ERAS protocol and traditional protocol, respectively.
Results


Compared to the control group, the ERAS group had significantly fewer patients with intraoperative nausea, pain of visual analog scale (VAS) scores, and VAS grade >3 during rest in the first 24 h and during motion in the first 24 and 48 h after surgery. There were no intergroup differences in the requirement of extra analgesics, the incidence of vomiting, shivering, hypotension, postoperative nausea, and pruritus. None of the patients in either group had postoperative vomiting. Patient satisfaction rated as per the VAS was significantly higher in the ERAS group than in the control group. The total length of stay, postoperative length of stay, and the cost of anesthesia in both groups were comparable. Further, the average daily hospitalization cost was significantly lower in the ERAS group than in the control group.
Conclusion


The ERAS protocol shows promise and appears to be worthwhile for widespread implementation among patients undergoing elective cesarean delivery; it was found to be beneficial in reducing the postoperative pain, incidence of intraoperative nausea, and average cost of hospitalization and also improved patient satisfaction.",2020,"There were no intergroup differences in the requirement of extra analgesics, the incidence of vomiting, shivering, hypotension, postoperative nausea, and pruritus.","['Acute Pain Management', 'patients undergoing elective cesarean delivery', 'Methods\n\n\nPatients who underwent elective cesarean delivery']","['ERAS group and control group -\xa0and the groups were managed with the ERAS protocol and traditional protocol, respectively', 'ERAS', 'Surgery (ERAS', 'surgery (ERAS) protocol']","['postoperative vomiting', 'pain management, hospital stay, hospitalization costs, and adverse reactions', 'Patient satisfaction rated as per the VAS', 'total length of stay, postoperative length of stay, and the cost of anesthesia', 'average daily hospitalization cost', 'intraoperative nausea, pain of visual analog scale (VAS) scores, and VAS grade >3 during rest', 'requirement of extra analgesics, the incidence of vomiting, shivering, hypotension, postoperative nausea, and pruritus', 'postoperative pain, incidence of intraoperative nausea']","[{'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0520905', 'cui_str': 'Postoperative vomiting'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",,0.0411586,"There were no intergroup differences in the requirement of extra analgesics, the incidence of vomiting, shivering, hypotension, postoperative nausea, and pruritus.","[{'ForeName': 'Jingru', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': ""Department of Anesthesiology, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Ziqing', 'Initials': 'Z', 'LastName': 'Hei', 'Affiliation': ""Department of Anesthesiology, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': ""Department of Anesthesiology, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Hongying', 'Initials': 'H', 'LastName': 'Hou', 'Affiliation': ""Department of Obstetrics, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Huizhen', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Chulian', 'Initials': 'C', 'LastName': 'Gong', 'Affiliation': ""Department of Anesthesiology, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Shaoli', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China.""}]",Therapeutics and clinical risk management,['10.2147/TCRM.S244039']
3005,31469027,"Effect of phytic acid on postprandial serum uric acid level in healthy volunteers: a randomized, double-blind, crossover study.","Phytic acid, a constituent of various plants, has been related to health benefits. Phytic acid has been shown to inhibit purine nucleotide metabolism in vitro and suppress elevation of plasma uric acid levels after purine administration in animal models. This study investigated the effect of phytic acid on postprandial serum uric acid (SUA) in humans. This randomized, double-blind, crossover design study included 48 healthy subjects with normal fasting SUA. Subjects consumed a control drink and a phytic acid drink with purine-rich food, and serum and urine uric acid levels were measured for 360 min after purine loading. Phytic acid lowered the incremental area under the curve (0-360 min) and incremental maximum concentration of SUA after purine loading ( p  < 0.05); tended to lower cumulative urinary uric acid excretion (0-360 min) after purine loading ( p  < 0.10); and suppressed postprandial SUA in this clinical study. Altogether, our findings suggest that phytic acid may play a beneficial role in controlling postprandial SUA.",2020,Phytic acid lowered the incremental area under the curve (0-360 min) and incremental maximum concentration of SUA after purine loading ( p  < 0.05); tended to lower cumulative urinary uric acid excretion (0-360 min) after purine loading ( p  < 0.10); and suppressed postprandial SUA in this clinical study.,"['humans', 'healthy volunteers', '48 healthy subjects with normal fasting SUA']",['phytic acid'],"['postprandial serum uric acid level', 'plasma uric acid levels', 'cumulative urinary uric acid excretion', 'postprandial SUA', 'Phytic acid', 'postprandial serum uric acid (SUA']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0031855', 'cui_str': 'Phytic Acid'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0857451', 'cui_str': 'Plasma uric acid'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0031855', 'cui_str': 'Phytic Acid'}]",48.0,0.202114,Phytic acid lowered the incremental area under the curve (0-360 min) and incremental maximum concentration of SUA after purine loading ( p  < 0.05); tended to lower cumulative urinary uric acid excretion (0-360 min) after purine loading ( p  < 0.10); and suppressed postprandial SUA in this clinical study.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ikenaga', 'Affiliation': 'Otsu Nutraceuticals Research Institute, Nutraceuticals Division, Otsuka Pharmaceutical Co., Ltd, Shiga, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Noguchi', 'Affiliation': 'Otsu Nutraceuticals Research Institute, Nutraceuticals Division, Otsuka Pharmaceutical Co., Ltd, Shiga, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kakumoto', 'Affiliation': 'Tokushima Research Institute, Pharmaceuticals Division, Otsuka Pharmaceutical Co., Ltd, Tokushima, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kohda', 'Affiliation': 'Otsu Nutraceuticals Research Institute, Nutraceuticals Division, Otsuka Pharmaceutical Co., Ltd, Shiga, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tsukikawa', 'Affiliation': 'Fukuoka Mirai Hospital Clinical Research Center, Souseikai Medical Corporation, Fukuoka, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Matsuguma', 'Affiliation': 'Fukuoka Mirai Hospital Clinical Research Center, Souseikai Medical Corporation, Fukuoka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Health Evaluation Center, Osaka Gyoumeikan Hospital, Osaka, Japan.'}]","Nucleosides, nucleotides & nucleic acids",['10.1080/15257770.2019.1656337']
3006,32440230,The Impact of Spinal Anesthesia and Use of Oxytocin on Fluid Absorption in Patients Undergoing Operative Hysteroscopy: Results from a Prospective Controlled Study.,"Objective


The aim of this study was to determine if combining intravenous oxytocin infusion and spinal anesthesia will reduce the amount of glycine absorption in patients undergoing operative hysteroscopy.
Patients and Methods


A prospective controlled study was conducted in premenopausal patients who had hysteroscopic surgery including endometrial resection, endometrial polypectomy, myomectomy resection and uterine septal resection. The effect of combined spinal anesthetic with oxytocin infusion on fluid deficit was studied.
Results


A total of 88 patients were studied. Sixty-two cases were done under general anesthesia (control group) and 26 cases were performed with spinal anesthesia and the use of oxytocin infusion (study group). There was a statistically significant less mean fluid deficit in the study group than control group in the endometrial polypectomy patients (220±36 mL vs 392±178 mL, respectively, P value 0.010, 95% C.I.: 163-276) and the myomectomy patients (308±66 mL vs 564±371 mL, respectively, P value 0.003, 95% C.I.: 239-378). In the endometrial resections, there was also a statistically significant less mean fluid deficit in the study than the control group (P value ˂ 0.001). Regarding septal resection, there was no statistically significant difference in the mean fluid deficit between the two groups (P value 0.833).
Conclusion


Spinal anesthesia combined with intravenous oxytocin infusion in operative hysteroscopy results in a statistically significant reduction in the glycine fluid deficit than the general anesthesia. We also recommend studying the effects of this combination in operative hysteroscopy using bipolar devices with isotonic solutions.",2020,"In the endometrial resections, there was also a statistically significant less mean fluid deficit in the study than the control group (P value ˂ 0.001).","['Sixty-two cases were done under general anesthesia (control group) and 26 cases were performed with', '88 patients were studied', 'Patients Undergoing Operative Hysteroscopy\ufeff', 'premenopausal patients who had', 'patients undergoing operative hysteroscopy']","['oxytocin', 'isotonic solutions', 'hysteroscopic surgery including endometrial resection, endometrial polypectomy, myomectomy resection and uterine septal resection', 'spinal anesthesia and the use of oxytocin infusion', 'oxytocin infusion', 'Oxytocin', 'oxytocin infusion and spinal anesthesia']","['fluid deficit', 'mean fluid deficit', 'glycine fluid deficit', 'Fluid Absorption']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0022260', 'cui_str': 'Isotonic Solutions'}, {'cui': 'C0751614', 'cui_str': 'Surgical Procedures, Hysteroscopic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0404115', 'cui_str': 'Endometrial resection'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0442004', 'cui_str': 'Septal'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",88.0,0.084883,"In the endometrial resections, there was also a statistically significant less mean fluid deficit in the study than the control group (P value ˂ 0.001).","[{'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Al-Husban', 'Affiliation': 'Obstetrics and Gynecology Department, School of Medicine, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Abdelkarim', 'Initials': 'A', 'LastName': 'Aloweidi', 'Affiliation': 'Department of Anesthesia, School of Medicine, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Ababneh', 'Affiliation': 'Department of Anesthesia, School of Medicine, The University of Jordan, Amman, Jordan.'}]",International journal of women's health,['10.2147/IJWH.S249619']
3007,32440111,Effect of Gender on Lung Function and Patient-Reported Outcomes in Patients with COPD Receiving Nebulized Glycopyrrolate.,"Purpose


The clinical manifestation of COPD can differ by gender, with women experiencing worse lung function and health-related quality of life than men. Additionally, women tend to report more symptoms given the same disease severity. Accordingly, the impact of gender on efficacy and safety in patients with moderate-to-very-severe COPD was examined following 12 weeks of nebulized glycopyrrolate (GLY) 25 µg twice daily (BID) or placebo.
Patients and Methods


GLY and placebo pooled data from the replicate 12-week GOLDEN 3 and 4 studies (n=861) were grouped by gender. Endpoints reported were change from baseline in trough forced expiratory volume in 1 second (FEV 1 ), St George's Respiratory Questionnaire (SGRQ) and EXAcerbations of COPD Tool-Respiratory Symptoms (EXACT-RS) total scores. Safety was evaluated by reviewing the incidence of adverse events (AEs) and serious AEs.
Results


Men (placebo: 54.7%; GLY: 56.1%) were generally older with a greater proportion of high cardiovascular risk and use of background long-acting β 2 -agonists or inhaled corticosteroids. GLY treatment resulted in significant, clinically important improvements in trough FEV 1 , regardless of gender. Patients treated with GLY reported significant improvements in SGRQ total score, irrespective of gender; however, the improvement was numerically higher in women. Although EXACT-RS improved in both genders, only women experienced a significant improvement. Overall, GLY was well tolerated with a numerically lower incidence of AEs in men than women.
Conclusion


Treatment with nebulized GLY resulted in lung function, SGRQ total score, and EXACT-RS total score improvements regardless of gender. However, only EXACT-RS showed significantly greater improvements in women compared with men. Treatment with GLY was generally well tolerated across genders. These data support the efficacy and safety of GLY 25 µg BID in patients with moderate-to-very-severe COPD, independent of gender. Gender similarities in airflow improvement and differences in symptom-reporting augment the evidence supporting the consideration of individualized treatment plans for COPD patients.",2020,"Patients treated with GLY reported significant improvements in SGRQ total score, irrespective of gender; however, the improvement was numerically higher in women.","['women experiencing worse lung function and health-related quality of life than men', 'Patients with COPD Receiving', 'men than women', 'patients with moderate-to-very-severe COPD', 'GLY: 56.1%) were generally older with a greater proportion of high cardiovascular risk and use of background long-acting β 2 -agonists or inhaled corticosteroids', 'COPD patients']","['nebulized GLY', 'nebulized glycopyrrolate (GLY', 'Nebulized Glycopyrrolate', 'placebo']","['SGRQ total score', 'incidence of adverse events (AEs) and serious AEs', 'lung function, SGRQ total score, and EXACT-RS total score', 'efficacy and safety', ""trough forced expiratory volume in 1 second (FEV 1 ), St George's Respiratory Questionnaire (SGRQ) and EXAcerbations of COPD Tool-Respiratory Symptoms (EXACT-RS) total scores"", 'Lung Function']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",861.0,0.103846,"Patients treated with GLY reported significant improvements in SGRQ total score, irrespective of gender; however, the improvement was numerically higher in women.","[{'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Ohar', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Ayca', 'Initials': 'A', 'LastName': 'Ozol-Godfrey', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Goodin', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Sanjar', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S240303']
3008,31445400,Comparison of endocrowns made of lithium disilicate glass-ceramic or polymer-infiltrated ceramic networks and direct composite resin restorations: fatigue performance and stress distribution.,"This study compared the fatigue performance and the stress distribution of endodontically treated molars restored with endocrowns obtained with lithium disilicate glass-ceramic or a polymer-infiltrated ceramic network, both processed by CAD-CAM, and direct composite restorations. Forty-eight human mandibular molars were randomly assigned into 03 groups (n = 16) and restored with endocrowns (LD - lithium disilicate glass-ceramic or PICN - polymer-infiltrated ceramic network) or with direct composite restorations. Fatigue testing followed a step-stress approach (initial maximum load of 200 N and 5000 cycles, incremental step load of 200N and 10,000 cycles/step, being the specimens loaded until failure or to a maximum of 135,000 cycles at 2800 N). The fatigue failure load and number of cycles until failure were recorded and statistically analyzed. Fractographic and finite element (FEA) analyzes were conducted as well. There were no differences in fatigue failure load, number of cycles until fracture and mean survival probabilities among groups. However, indirect endocrowns had higher mechanical structural reliability, and LD restorations lasted more time before start to failing. FEA showed that the stress concentration in tooth tissues was higher for the resin composite, followed by PICN and LD in a decreasing order. Almost all fractures were restricted to the restorative material (without tooth involvement), and origins were identified at occlusal surface. The type of restoration did not influence the fatigue failure load, number of cycles until fracture and mean survival probabilities of the restorative strategies. Despite that, the mechanical structural reliability of endocrowns, especially those made of lithium disilicate, was higher and lasted more time before start to failing.",2019,"FEA showed that the stress concentration in tooth tissues was higher for the resin composite, followed by PICN and LD in a decreasing order.",['Forty-eight human mandibular molars'],"['FEA', 'lithium disilicate glass-ceramic', 'endocrowns (LD - lithium disilicate glass-ceramic or PICN - polymer-infiltrated ceramic network) or with direct composite restorations']","['fatigue performance', 'fatigue failure load, number of cycles until fracture and mean survival probabilities', 'fatigue failure load and number of cycles until failure', 'mechanical structural reliability', 'stress concentration in tooth tissues']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0026367', 'cui_str': 'Molar'}]","[{'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C1618088', 'cui_str': 'Glass ceramics'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]",48.0,0.0518471,"FEA showed that the stress concentration in tooth tissues was higher for the resin composite, followed by PICN and LD in a decreasing order.","[{'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Dartora', 'Affiliation': 'MSciD Post-Graduate Program in Dentistry, Meridional Faculty, IMED, Passo Fundo, Brazil. Electronic address: gustavo_dartora@hotmail.com.'}, {'ForeName': 'Gabriel Kalil', 'Initials': 'GK', 'LastName': 'Rocha Pereira', 'Affiliation': 'MSciD Post-Graduate Program in Dentistry, Meridional Faculty, IMED, Passo Fundo, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Varella de Carvalho', 'Affiliation': 'MSciD Post-Graduate Program in Dentistry, Meridional Faculty, IMED, Passo Fundo, Brazil. Electronic address: rodrigo.varella@gmail.com.'}, {'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, RS, Brazil. Electronic address: camila-svs@hotmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, RS, Brazil. Electronic address: lfvalandro@gmail.com.'}, {'ForeName': 'Paulo Francisco', 'Initials': 'PF', 'LastName': 'Cesar', 'Affiliation': 'Department of Biomaterials and Oral Biology, University of São Paulo, USP, São Paulo, Brazil. Electronic address: paulofc@usp.br.'}, {'ForeName': 'Ricardo Armini', 'Initials': 'RA', 'LastName': 'Caldas', 'Affiliation': 'Department of Prosthodontics, FAESA / Centro Universitário, Vitória, ES, Brazil. Electronic address: ricardocaldas100@gmail.com.'}, {'ForeName': 'Atais', 'Initials': 'A', 'LastName': 'Bacchi', 'Affiliation': 'MSciD Post-Graduate Program in Dentistry, Meridional Faculty, IMED, Passo Fundo, Brazil. Electronic address: atais_bacchi@yahoo.com.br.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.103401']
3009,31469393,Effect of Sequential or Active Choice for Colorectal Cancer Screening Outreach: A Randomized Clinical Trial.,"Importance


Colonoscopy and fecal immunochemical testing (FIT) are considered top-tier tests for colorectal cancer (CRC) screening. Behavioral economic insights about ""choice architecture"" suggest that participation could be influenced by how people are presented test options.
Objective


To investigate response rates for offering colonoscopy only compared with sequential choice (colonoscopy and then FIT) or active choice (colonoscopy or FIT) through mailed outreach.
Design, Setting, and Participants


Three-arm pragmatic randomized clinical trial conducted between November 14, 2017, and May 14, 2018. The setting was primary care practices at an academic health system. Patients aged 50 to 74 years with at least 2 primary care visits in the 2-year preenrollment period were included if they were eligible but not up to date on CRC screening.
Interventions


Eligible patients received mailed outreach about CRC screening. Equal numbers of eligible patients were randomly assigned to 3 outreach groups to receive mailings about CRC screening with the following options: (1) direct phone number to call for scheduling colonoscopy (colonoscopy only), (2) direct phone number to call for colonoscopy and a mailed FIT kit if no response within 4 weeks (sequential choice), or (3) direct phone number to call for colonoscopy and a mailed FIT kit offered at the same time (active choice).
Main Outcomes and Measures


The primary outcome was CRC screening completion (FIT or colonoscopy) within 4 months of initial outreach. The secondary outcomes were CRC screening completion within 6 months of outreach and the choice of colonoscopy as a screening test.
Results


In total, 438 patients were included in the intent-to-treat analysis, with a median age of 56 years (interquartile range, 52-63 years); 55.0% were women. At 4 months, the CRC screening completion rates were 14.4% (95% CI, 8.7%-20.1%) in the colonoscopy-only arm, 17.1% (95% CI, 11.0%-23.2%) in the sequential choice arm, and 19.9% (95% CI, 13.4%-26.4%) in the active choice arm. Neither choice arm achieved a screening rate statistically greater than that in the colonoscopy-alone arm. Among those who completed CRC screening at 4 months, 90.5% (95% CI, 78.0%-103.0%) chose colonoscopy in the colonoscopy-only arm, which was significantly higher than the 52.0% (95% CI, 32.4%-71.6%; P = .005) and 37.9% (95% CI, 20.2%-55.6%; P < .001) in the sequential choice and active choice arms, respectively.
Conclusions and Relevance


There was no significant increase in CRC screening when offering sequential or active choice, but there was a lower rate of colonoscopy in the choice arms than in the colonoscopy-only arm. Subtle changes in sequencing or defaults can alter patient decision making related to preventive health.
Trial Registration


ClinicalTrials.gov identifier: NCT03246438.",2019,"There was no significant increase in CRC screening when offering sequential or active choice, but there was a lower rate of colonoscopy in the choice arms than in the colonoscopy-only arm.","['438 patients were included in the intent-to-treat analysis, with a median age of 56 years (interquartile range, 52-63 years); 55.0% were women', 'Patients aged 50 to 74 years with at least 2 primary care visits in the 2-year preenrollment period were included if they were eligible but not up to date on CRC screening', 'Colorectal Cancer Screening Outreach', 'Equal numbers of eligible patients', 'Participants\n\n\nThree-arm pragmatic randomized clinical trial conducted between November 14, 2017, and May 14, 2018']","['sequential choice (colonoscopy and then FIT) or active choice (colonoscopy or FIT', 'mailed outreach about CRC screening', 'Importance\n\n\nColonoscopy and fecal immunochemical testing (FIT', 'mailings about CRC screening with the following options: (1) direct phone number to call for scheduling colonoscopy (colonoscopy only), (2) direct phone number to call for colonoscopy and a mailed FIT kit if no response within 4 weeks (sequential choice), or (3) direct phone number to call for colonoscopy and a mailed FIT kit offered at the same time (active choice', 'Sequential or Active Choice']","['CRC screening', 'CRC screening completion rates', 'screening rate', 'rate of colonoscopy', 'CRC screening completion within 6 months of outreach and the choice of colonoscopy as a screening test', 'CRC screening completion (FIT or colonoscopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property) (qualifier value)'}, {'cui': 'C1446911', 'cui_str': 'Scheduling'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]",438.0,0.191216,"There was no significant increase in CRC screening when offering sequential or active choice, but there was a lower rate of colonoscopy in the choice arms than in the colonoscopy-only arm.","[{'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Vikranth', 'Initials': 'V', 'LastName': 'Induru', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Santos', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reitz', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'McAuliffe', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Orellana', 'Affiliation': 'Clinical Care Associates, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Chyke A', 'Initials': 'CA', 'LastName': 'Doubeni', 'Affiliation': 'Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.10305']
3010,31371228,"Adjuvant hyperthermic intraperitoneal chemotherapy in patients with locally advanced colon cancer (COLOPEC): a multicentre, open-label, randomised trial.","BACKGROUND


Nearly a quarter of patients with locally advanced (T4 stage) or perforated colon cancer are at risk of developing peritoneal metastases, often without curative treatment options. We aimed to determine the efficacy of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with locally advanced colon cancer.
METHODS


This multicentre, open-label trial was done in nine hospitals that specialised in HIPEC in the Netherlands. Patients with clinical or pathological T4N0-2M0-stage tumours or perforated colon cancer were randomly assigned (1:1), with a web-based randomisation application, before resection of the primary tumour, to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy (experimental group) or to adjuvant systemic chemotherapy alone (control group). Patients were stratified by tumour characteristic (T4 or perforation), age (<65 years or ≥65 years), and surgical approach of the primary tumour resection (laparoscopic or open). Key eligibility criteria included age between 18 and 75 years, adequate clinical condition for HIPEC, and intention to start adjuvant systemic chemotherapy. Patients with metastatic disease were ineligible. Adjuvant HIPEC consisted of fluorouracil (400 mg/m 2 ) and leucovorin (20 mg/m 2 ) delivered intravenously followed by intraperitoneal delivery of oxaliplatin (460 mg/m 2 ) for 30 min at 42°C, delivered simultaneously or within 5-8 weeks after primary tumour resection. In all patients without evidence of recurrent disease at 18 months, a diagnostic laparoscopy was done. The primary endpoint was peritoneal metastasis free-survival at 18 months, measured in the intention-to-treat population, with the Kaplan-Meier method. Adverse events were assessed in all patients who received assigned treatment. This study is registered with ClinicalTrials.gov, number NCT02231086.
FINDINGS


Between April 1, 2015, and Feb 20, 2017, 204 patients were randomly assigned to treatment (102 in each group). In the HIPEC group, two patients withdrew consent after randomisation. In this group, 19 (19%) of 100 patients were diagnosed with peritoneal metastases: nine (47%) during surgical exploration preceding intentional adjuvant HIPEC, eight (42%) during routine follow-up, and two (11%) during diagnostic laparoscopy at 18-months. In the control group, 23 (23%) of 102 patients were diagnosed with peritoneal metastases, of whom seven (30%) were diagnosed by laparoscopy at 18-months and 16 during regular follow-up (therefore making them ineligible for diagnostic laparoscopy). In the intention-to-treat analysis (n=202), there was no difference in peritoneal-free survival at 18-months (80·9% [95% CI 73·3-88·5] for the experimental group vs 76·2% [68·0-84·4] for the control group, log-rank one-sided p=0·28). 12 (14%) of 87 patients who received adjuvant HIPEC developed postoperative complications and one (1%) encapsulating peritoneal sclerosis.
INTERPRETATION


In patients with T4 or perforated colon cancer, treatment with adjuvant HIPEC with oxaliplatin did not improve peritoneal metastasis-free survival at 18 months. Routine use of adjuvant HIPEC is not advocated on the basis of this trial.
FUNDING


Organization for Health Research and Development and the Dutch Cancer Society.",2019,"In the intention-to-treat analysis (n=202), there was no difference in peritoneal-free survival at 18-months (80·9% [95% CI 73·3-88·5] for the experimental group vs 76·2% [68·0-84·4] for the control group, log-rank one-sided p=0·28).","['patients with locally advanced colon cancer (COLOPEC', 'nine hospitals that specialised in HIPEC in the Netherlands', 'patients with locally advanced (T4 stage) or perforated colon cancer', 'Patients with clinical or pathological T4N0-2M0-stage tumours or perforated colon cancer', '204 patients', 'Between April 1, 2015, and Feb 20, 2017', '100 patients were diagnosed with peritoneal metastases: nine (47%) during surgical exploration preceding intentional adjuvant HIPEC, eight (42%) during routine follow-up, and two (11%) during diagnostic laparoscopy at 18-months', '102 patients were diagnosed with peritoneal metastases, of whom seven (30%) were diagnosed by laparoscopy at 18-months and 16 during regular follow-up (therefore making them ineligible for diagnostic laparoscopy', 'patients with locally advanced colon cancer', 'Key eligibility criteria included age between 18 and 75 years, adequate clinical condition for HIPEC, and intention to start adjuvant systemic chemotherapy', 'patients with T4 or perforated colon cancer', 'Patients with metastatic disease were ineligible', 'Patients were stratified by tumour characteristic (T4 or perforation), age (<65 years or ≥65 years), and surgical approach of the primary tumour resection (laparoscopic or open']","['Adjuvant hyperthermic intraperitoneal chemotherapy', 'adjuvant HIPEC with oxaliplatin', 'leucovorin', 'oxaliplatin', 'adjuvant HIPEC followed by routine adjuvant systemic chemotherapy (experimental group) or to adjuvant systemic chemotherapy alone (control group', 'adjuvant HIPEC', 'adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC', 'fluorouracil']","['peritoneal metastasis free-survival', 'peritoneal metastasis-free survival', 'Adverse events', 'peritoneal-free survival', 'postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C0475751', 'cui_str': 'Tumor stage T4'}, {'cui': 'C0347646', 'cui_str': 'Perforation of colon (disorder)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant peritoneal deposit'}, {'cui': 'C0184899', 'cui_str': 'Exploratory incision (procedure)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1880304', 'cui_str': 'Diagnostic laparoscopy (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0449446', 'cui_str': 'Surgical approach (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0346989', 'cui_str': 'Secondary malignant peritoneal deposit'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",204.0,0.281255,"In the intention-to-treat analysis (n=202), there was no difference in peritoneal-free survival at 18-months (80·9% [95% CI 73·3-88·5] for the experimental group vs 76·2% [68·0-84·4] for the control group, log-rank one-sided p=0·28).","[{'ForeName': 'Charlotte E L', 'Initials': 'CEL', 'LastName': 'Klaver', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Wisselink', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Cornelis J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Department of Oncology, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Petur', 'Initials': 'P', 'LastName': 'Snaebjornsson', 'Affiliation': 'Department of Pathology, Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Crezee', 'Affiliation': 'Department of Radiation Oncology, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Arend G J', 'Initials': 'AGJ', 'LastName': 'Aalbers', 'Affiliation': 'Department of Surgery, Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brandt', 'Affiliation': 'Department of Surgery, Erasmus Medical centre at Daniel den Hoed, Rotterdam, Netherlands.'}, {'ForeName': 'Andre J A', 'Initials': 'AJA', 'LastName': 'Bremers', 'Affiliation': 'Department of Surgery, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Jacobus W A', 'Initials': 'JWA', 'LastName': 'Burger', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Hans F J', 'Initials': 'HFJ', 'LastName': 'Fabry', 'Affiliation': 'Department of Surgery, Bravis Hospital, Roosendaal, Netherlands.'}, {'ForeName': 'Floris', 'Initials': 'F', 'LastName': 'Ferenschild', 'Affiliation': 'Department of Surgery, Maasziekenhuis Pantein, Beugen, Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Festen', 'Affiliation': 'Department of Surgery, Onze Lieve Vrouwen Gasthuis, Amsterdam, Netherlands.'}, {'ForeName': 'Wilhelmina M U', 'Initials': 'WMU', 'LastName': 'van Grevenstein', 'Affiliation': 'Department of Surgery, University Medical Centre Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Patrick H J', 'Initials': 'PHJ', 'LastName': 'Hemmer', 'Affiliation': 'Department of Surgery, Universitair Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Ignace H J T', 'Initials': 'IHJT', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Niels F M', 'Initials': 'NFM', 'LastName': 'Kok', 'Affiliation': 'Department of Surgery, Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Gijsbert D', 'Initials': 'GD', 'LastName': 'Musters', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Schoonderwoerd', 'Affiliation': 'Department of Surgery, Bernhoven, Uden, Netherlands.'}, {'ForeName': 'Jurriaan B', 'Initials': 'JB', 'LastName': 'Tuynman', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Free University, Cancer Centre Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Anthony W H', 'Initials': 'AWH', 'LastName': 'van de Ven', 'Affiliation': 'Department of Surgery, Flevo hospital, Almere, Netherlands.'}, {'ForeName': 'Henderik L', 'Initials': 'HL', 'LastName': 'van Westreenen', 'Affiliation': 'Department of Surgery, Isala Hospital, Zwolle, Netherlands.'}, {'ForeName': 'Marinus J', 'Initials': 'MJ', 'LastName': 'Wiezer', 'Affiliation': 'Department of Surgery, St Antonius Hospital, CM Nieuwegein, Netherlands.'}, {'ForeName': 'David D E', 'Initials': 'DDE', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Surgery, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Annette A', 'Initials': 'AA', 'LastName': 'van Zweeden', 'Affiliation': 'Department of Internal Medicine, Amstelland Hospital, Amstelveen, Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Tanis', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands. Electronic address: p.j.tanis@amsterdamumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30239-0']
3011,32440267,A comparative study of sequential vs. simultaneous type I tympanoplasty in patients with bilateral chronic otitis media - Mucosal type.,"Background


Patients with bilateral chronic otitis media - mucosal type have been conventionally treated with sequential tympanoplasty. Bilateral simultaneous tympanoplasty is usually not preferred because of the theoretical risk of iatrogenic sensorineural hearing loss. With the advent of modern surgical instruments and surgical techniques, the risk is expected to be lower. This study compares the clinical outcomes in type I tympanoplasty performed simultaneously and sequentially.
Materials & methods


This randomized prospective study was carried out in a tertiary care hospital between August 2015 and July 2017. A total of 30 patients were divided into two groups of 15 each. This study analyzed the graft uptake, pure tone audiogram findings pre- and post-operatively, duration of surgery and number of hospital visit for each patient and the outcomes were compared between both the groups.
Result


Patients undergoing bilateral simultaneous tympanoplasty had significantly lesser mean duration of surgery and number of hospital visits than the patients undergoing sequential tympanoplasty. Graft uptake and postoperative wound infections were similar in both the groups. Postoperative hearing improvement was significantly better in the bilateral simultaneous tympanoplasty group. However, further studies are needed to authenticate this observation. None of the patients had a postoperative deterioration of hearing or sensorineural hearing loss.
Conclusion


Bilateral simultaneous tympanoplasty is not only feasible but also better than sequential tympanoplasty, especially in terms of operating time, follow-up and overall financial implications on the patient.",2020,Bilateral simultaneous tympanoplasty is usually not preferred because of the theoretical risk of iatrogenic sensorineural hearing loss.,"['\n\n\nPatients with bilateral chronic otitis media - mucosal type', 'patients with bilateral chronic otitis media - Mucosal type', '30 patients', 'tertiary care hospital between August 2015 and July 2017']",['sequential vs. simultaneous type I tympanoplasty'],"['Graft uptake and postoperative wound infections', 'postoperative deterioration of hearing or sensorineural hearing loss', 'Postoperative hearing improvement', 'mean duration of surgery and number of hospital visits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0271441', 'cui_str': 'Chronic otitis media'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",30.0,0.0251294,Bilateral simultaneous tympanoplasty is usually not preferred because of the theoretical risk of iatrogenic sensorineural hearing loss.,"[{'ForeName': 'Preethi', 'Initials': 'P', 'LastName': 'Umamaheswaran', 'Affiliation': 'Department of ENT, Head & Neck Surgery, Panimalar Medical College Hospital & Research Institute, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': 'Department of ENT, Head & Neck Surgery, MGM Healthcare, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Vinoth', 'Initials': 'V', 'LastName': 'Manimaran', 'Affiliation': 'Department of ENT, Head & Neck Surgery, Sri Ramachandra Institute of Higher Education & Research, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sathishkumar', 'Initials': 'S', 'LastName': 'Jayagandhi', 'Affiliation': 'Department of ENT, Head & Neck Surgery, Sri Ramachandra Institute of Higher Education & Research, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Shiva Priya', 'Initials': 'SP', 'LastName': 'Jeyabalakrishnan', 'Affiliation': 'Department of ENT, Head & Neck Surgery, Karpagam Faculty of Medical Sciences & Research, Coimbatore, Tamil Nadu, India.'}]",Journal of otology,['10.1016/j.joto.2019.12.005']
3012,32440409,Does Realism Matter? A Randomized Controlled Trial Comparing Models for Medical Student Suture Education.,"Background


We hypothesized that medical students trained in suturing using high-fidelity models (cadaveric tissue) would demonstrate greater proficiency when compared with those trained using low-fidelity models (synthetic tissue).
Methods


Forty-three medical students were randomized into 2 groups. Group 1 consisted of students taught to perform simple interrupted sutures using synthetic tissue, and group 2 consisted of those taught using human cadaveric tissue. Suturing proficiency was measured pre- and postinstruction using the Global Rating Scale and by measuring suture accuracy. Perceived confidence in suturing was measured on a scale of 0-100.
Results


Perceived confidence was measured as an average of 8.26 out of 100 pretraining and significantly improved after training (56.91 out of 100); however, there was no significant difference when comparing confidence between groups posttraining (57.65 cadaveric versus 56.05 synthetic;  P  = 0.78), nor in the measured confidence change pre- and posttraining ( P  = 0.53). Posttraining, participants displayed a significant improvement in the number of adequately placed sutures; however, there was no significant difference posttraining when comparing groups (2.43 cadaveric versus 2.75 synthetic;  P  = 0.48). The change in adequate suture placement pre- and posttraining did not reach statistical significance between groups ( P  = 0.27). After instruction, participants demonstrated a significant improvement in total suture performance scores; however, there was no significant difference when comparing groups (30.04 cadaveric versus 29.80 synthetic;  P  = 0.90), nor in the total change pre- and posttraining ( P  = 0.74).
Conclusions


Training medium fidelity (tissue versus synthetic) does not significantly influence a student's overall suturing performance. However, formal instruction significantly improves objective competence and perceived confidence. Regardless of the model, surgical departments should emphasize medical student exposure to basic surgical skills education.",2020,"Posttraining, participants displayed a significant improvement in the number of adequately placed sutures; however, there was no significant difference posttraining when comparing groups (2.43 cadaveric versus 2.75 synthetic;  P  = 0.48).","['Methods\n\n\nForty-three medical students', 'Medical Student Suture Education']","['students taught to perform simple interrupted sutures using synthetic tissue, and group 2 consisted of those taught using human cadaveric tissue']","['Global Rating Scale', 'Perceived confidence in suturing', 'total suture performance scores', 'objective competence and perceived confidence', 'number of adequately placed sutures']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442504', 'cui_str': 'Place'}]",100.0,0.0412224,"Posttraining, participants displayed a significant improvement in the number of adequately placed sutures; however, there was no significant difference posttraining when comparing groups (2.43 cadaveric versus 2.75 synthetic;  P  = 0.48).","[{'ForeName': 'Jared A', 'Initials': 'JA', 'LastName': 'Blau', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Ronnie L', 'Initials': 'RL', 'LastName': 'Shammas', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Anolik', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Yash J', 'Initials': 'YJ', 'LastName': 'Avashia', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Krucoff', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zenn', 'Affiliation': 'Zenn Plastic Surgery, Raleigh, N.C.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000002738']
3013,32440603,No Time-Dependent Effects of Psychosocial Stress on Fear Contextualization and Generalization: A Randomized-Controlled Study With Healthy Participants.,"The formation of context-dependent fear memories (fear contextualization) can aid the recognition of danger in new, similar, situations. Overgeneralization of fear is often seen as hallmark of anxiety and trauma-related disorders. In this randomized-controlled study, we investigated whether exposure to a psychosocial stressor influences retention of fear contextualization and generalization in a time-dependent manner. The Trier Social Stress Test was used to induce psychosocial stress. Healthy male participants (n = 117) were randomly divided into three experimental groups that were subjected to the acquisition phase of the Fear Generalization Task: (1) without stress, (2) immediately after acute stress, or (3) 2 h after acute stress. In this task, a male with neutral facial expression (conditioned stimuli) was depicted in two different contexts that modulated the conditioned stimuli-unconditioned stimuli (=shock) association (threat, safe). Salivary alpha-amylase and cortisol levels were measured throughout the experiment. After a 24-h delay, context-dependency of fear memory was investigated with an unannounced memory test consisting of the threat and safe contexts alternated with a novel context (the generalization context). Multilevel analyses revealed that participants showed increased fear-potentiated startle responses to the conditioned stimuli in the threat compared to the safe context, at the end of the acquisition phase, indicating adequate fear contextualization. Directly after acquisition, there were no time-dependent effects of psychosocial stress on fear contextualization. Context-dependency of fear memories was retained 24 h later, as fear-potentiated startle responding was modulated by context (threat > safe or novel). At that time, the context-dependency of fear memories was also not influenced by the early or late effects of the endogenous stress response during acquisition. These results with experimental stress deviate in some aspects from those earlier obtained with exogenous hydrocortisone administration, suggesting a distinct role for stress mediators other than cortisol.",2019,"Multilevel analyses revealed that participants showed increased fear-potentiated startle responses to the conditioned stimuli in the threat compared to the safe context, at the end of the acquisition phase, indicating adequate fear contextualization.","['male with neutral facial expression (conditioned stimuli', 'Healthy Participants', 'Healthy male participants (n\u2009=\u2009117']",['hydrocortisone'],"['Fear Contextualization and Generalization', 'fear-potentiated startle responses', 'Salivary alpha-amylase and cortisol levels']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0017324', 'cui_str': 'Generalization (Psychology)'}, {'cui': 'C0038186', 'cui_str': 'Startle Reaction'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",117.0,0.0146613,"Multilevel analyses revealed that participants showed increased fear-potentiated startle responses to the conditioned stimuli in the threat compared to the safe context, at the end of the acquisition phase, indicating adequate fear contextualization.","[{'ForeName': 'Milou S C', 'Initials': 'MSC', 'LastName': 'Sep', 'Affiliation': 'Brain Research and Innovation Centre, Ministry of Defence, Utrecht, the Netherlands.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Gorter', 'Affiliation': 'Brain Research and Innovation Centre, Ministry of Defence, Utrecht, the Netherlands.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'van Ast', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Joëls', 'Affiliation': 'Department of Translational Neuroscience, UMC Utrecht Brain Center, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Elbert', 'Initials': 'E', 'LastName': 'Geuze', 'Affiliation': 'Brain Research and Innovation Centre, Ministry of Defence, Utrecht, the Netherlands.'}]","Chronic stress (Thousand Oaks, Calif.)",['10.1177/2470547019896547']
3014,32440233,The Effect of a Midwife-Based Group Discussion Education on Sexual Dysfunction Beliefs in Rural Postmenopausal Women.,"Introduction


Correcting sexual beliefs can affect women's sexual function. There are very limited interventional studies on correcting the sexual dysfunction beliefs in postmenopausal women living in rural areas. Therefore, the present study was carried out with the aim of investigating the effect of a midwife-based group education on sexual dysfunction beliefs in one group of rural postmenopausal women.
Methods


The present study was a quasi-experimental pre-post design without a control group. The study population included rural menopausal women who referred to rural health centers. The study sample consisted of 50 participants who have all received education program. The education was held in six group discussion sessions. The data gathering tool used in this study was the Sexual Dysfunctional Beliefs Questionnaire which was completed before and after the education. This questionnaire consists of 33 items and includes 6 subscales.
Results


The mean age of participants was 53.26 years. Approximately half of the participants (48%) had primary education. The mean scores of sexual dysfunction beliefs before and after education were 114.58 and 58.56, respectively (p-value<0.001). The mean scores of sexual conersations, affection primacy, motherhood-related beliefs, sexual desire and pleasure as sin beliefs, age-related beliefs, and body image beliefs before intervention were 14.38, 21.38, 13.9, 23.64, 20.74, 17.04, respectively, and after intervention were 6.9, 11.80, 8.64, 12.48, 7.7, 9.40, respectively.
Conclusion


Rural postmenopausal women had problems with sexual dysfunction beliefs. A midwife-based group discussion education on this matter had significantly improved the sexual dysfunction beliefs in them. Further studies are needed in this regard.",2020,"The mean scores of sexual dysfunction beliefs before and after education were 114.58 and 58.56, respectively (p-value<0.001).","['postmenopausal women living in rural areas', 'Rural postmenopausal women had problems with sexual dysfunction beliefs', 'Rural Postmenopausal Women', '50 participants who have all received education program', 'one group of rural postmenopausal women', 'rural menopausal women who referred to rural health centers']","['midwife-based group education', 'Midwife-Based Group Discussion Education']","['Sexual Dysfunction Beliefs', 'Sexual Dysfunctional Beliefs Questionnaire', 'mean scores of sexual conersations, affection primacy, motherhood-related beliefs, sexual desire and pleasure as sin beliefs, age-related beliefs, and body image beliefs', 'mean scores of sexual dysfunction beliefs', 'sexual dysfunction beliefs']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0035960', 'cui_str': 'Rural health center'}]","[{'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0337490', 'cui_str': 'Motherhood'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0333873', 'cui_str': 'Squamous intraepithelial lesion'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]",50.0,0.0319069,"The mean scores of sexual dysfunction beliefs before and after education were 114.58 and 58.56, respectively (p-value<0.001).","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Sasanpour', 'Affiliation': 'Student Research Committee, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Nezal', 'Initials': 'N', 'LastName': 'Azh', 'Affiliation': 'Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Alipour', 'Affiliation': 'Faculty of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}]",International journal of women's health,['10.2147/IJWH.S242621']
3015,32440243,Results of a Single Arm Pilot Study of a Mobile Messaging Intervention for Hookah Tobacco Cessation in Young Adults.,"Background


Hookah tobacco use is common among young adults. Unlike cigarette smoking, there is limited evidence on mobile (ie, mHealth) interventions to promote cessation.
Objectives


This pilot study tested the preliminary effects of mobile messaging for cessation in young adult hookah smokers.
Methods


Young adults (N = 20) aged 18 to 30 years who smoke hookah at least monthly and have done so at least once in the past 30 days received a 6-week mHealth multimedia messaging (text and images) intervention. Message scheduling (2 days/week × 6 weeks) was based on the literature. Content was developed iteratively by the study team and focused on health harms and addictiveness of hookah. Content was individually tailored by baseline hookah use frequency, risk beliefs, and responses to interactive text messages assessing participants' hookah tobacco use behavior and beliefs to maximize impact. Engagement was assessed during the intervention, and we examined effects on risk perceptions, risk beliefs, and risk appraisals, motivation to quit, and behavior change immediately post-intervention.
Results


Participants responded to 11.5 (SD = 0.69) of 12 text message prompts on average, endorsed high message receptivity (M = 6.1, SD = 0.93, range = 1-7), and reported the messages were helpful (M = 8.5, SD = 1.5, range = 1-10). There were significant ( P  < .05) increases in risk perceptions (d's = 0.22-0.88), risk appraisals (d = 0.49), risk beliefs (d = 1.11), and motivation to quit (d = 0.97) post-intervention. Half of participants reported reducing frequency of hookah use (20%) or quitting completely (30%) by end of treatment.
Conclusions


These pilot results provide preliminary support for an mHealth messaging intervention about risks of hookah tobacco for promoting cessation. Rigorously examining the efficacy of this promising intervention is warranted.",2020,"There were significant ( P  < .05) increases in risk perceptions (d's = 0.22-0.88), risk appraisals (d = 0.49), risk beliefs (d = 1.11), and motivation to quit (d = 0.97) post-intervention.","['young adult hookah smokers', 'young adults', 'Young Adults', 'Methods\n\n\nYoung adults (N\u2009=\u200920) aged 18 to 30\u2009years who smoke hookah at least monthly and have done so at least once in the past 30\u2009days received a']","['mobile messaging', '6-week mHealth multimedia messaging (text and images) intervention', 'Mobile Messaging Intervention']","['risk appraisals', 'risk beliefs', 'motivation to quit', 'risk perceptions, risk beliefs, and risk appraisals, motivation to quit, and behavior change immediately post-intervention', 'frequency of hookah use', 'risk perceptions']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4302493', 'cui_str': 'Hookah pipe'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C4302493', 'cui_str': 'Hookah pipe'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.17273,"There were significant ( P  < .05) increases in risk perceptions (d's = 0.22-0.88), risk appraisals (d = 0.49), risk beliefs (d = 1.11), and motivation to quit (d = 0.97) post-intervention.","[{'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'Cancer Prevention and Control Program, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Lilianna', 'Initials': 'L', 'LastName': 'Phan', 'Affiliation': 'Cancer Prevention and Control Program, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Johnson', 'Affiliation': 'Cancer Prevention and Control Program, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Tercyak', 'Affiliation': 'Cancer Prevention and Control Program, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Snow', 'Affiliation': 'Department of Human Science, School of Nursing and Health Studies, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Luta', 'Affiliation': 'Department of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rehberg', 'Affiliation': 'Cancer Prevention and Control Program, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Lipkus', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}]",Tobacco use insights,['10.1177/1179173X20915200']
3016,32440592,"An Open-Label Feasibility Trial Examining the Effectiveness of a Cognitive Training Program, Goal Management Training, in Individuals With Posttraumatic Stress Disorder.","Background


Posttraumatic stress disorder (PTSD) is associated with dysfunction across multiple cognitive domains including executive functioning, attention, and verbal memory. This dysfunction is associated with negative impacts on functional outcomes (e.g., work or social functioning) and reduced response to psychotherapy for PTSD. Despite this knowledge, little work has investigated the efficacy of cognitive remediation strategies in improving cognition and functional outcomes among individuals with PTSD.
Objective


The current study investigated the efficacy of an established cognitive remediation program, Goal Management Training (GMT), in improving cognitive functioning in a pilot sample of individuals with PTSD symptoms in an inpatient treatment setting.
Method


Thirty-four inpatients with PTSD symptoms participated in either GMT in addition to treatment as usual (TAU; consisting of psychiatric management, group and individual psychotherapy) (TAU+GMT;  n  = 18) or TAU alone ( n =  16). The TAU+GMT group received neuropsychological assessment at baseline and posttreatment, while both the TAU+GMT and TAU groups received assessment with clinical self-report measures at baseline and posttreatment.
Results


Paired-sample t-tests revealed significant improvements on measures of executive functioning (e.g., response inhibition, cognitive flexibility), processing speed, sustained attention, and verbal memory in the TAU+GMT group. Mixed-design analyses of variance (ANOVAs) revealed a trend toward an interaction effect indicating potentially greater improvements on a measure of the ability to engage in goal-directed behaviors while highly emotional in the TAU+GMT group as compared to the TAU group.
Discussion


The results of this small feasibility investigation of GMT in PTSD point toward the potential efficacy of GMT in ameliorating cognitive difficulties in individuals with PTSD.",2019,"Paired-sample t-tests revealed significant improvements on measures of executive functioning (e.g., response inhibition, cognitive flexibility), processing speed, sustained attention, and verbal memory in the TAU+GMT group.","['\n\n\nPosttraumatic stress disorder (PTSD', 'Individuals With Posttraumatic Stress Disorder', 'individuals with PTSD', 'individuals with PTSD symptoms in an inpatient treatment setting', 'Method\n\n\nThirty-four inpatients with PTSD symptoms participated in either']","['Cognitive Training Program, Goal Management Training', 'usual (TAU; consisting of psychiatric management, group and individual psychotherapy) (TAU+GMT;  n \u2009=\u200918) or TAU alone', 'established cognitive remediation program, Goal Management Training (GMT', 'TAU+GMT and TAU', 'GMT', 'TAU+GMT']","['executive functioning (e.g., response inhibition, cognitive flexibility), processing speed, sustained attention, and verbal memory']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}]",34.0,0.0142751,"Paired-sample t-tests revealed significant improvements on measures of executive functioning (e.g., response inhibition, cognitive flexibility), processing speed, sustained attention, and verbal memory in the TAU+GMT group.","[{'ForeName': 'Jenna E', 'Initials': 'JE', 'LastName': 'Boyd', 'Affiliation': 'Department of Psychology, Neuroscience, and Behaviour, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Homewood Research Institute, Guelph, Ontario, Canada.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Protopopescu', 'Affiliation': 'Department of Psychology, Neuroscience, and Behaviour, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Jetly', 'Affiliation': 'Directorate of Mental Health, Canadian Forces Health Services Group Headquarters, Department of National Defence, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shawn G', 'Initials': 'SG', 'LastName': 'Rhind', 'Affiliation': 'Defence Research and Development Canada, Toronto Research Centre, Ontario, Canada.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Lanius', 'Affiliation': 'Homewood Research Institute, Guelph, Ontario, Canada.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'McKinnon', 'Affiliation': 'Department of Psychology, Neuroscience, and Behaviour, McMaster University, Hamilton, Ontario, Canada.'}]","Chronic stress (Thousand Oaks, Calif.)",['10.1177/2470547019841599']
3017,32440199,Oxycodone vs Sufentanil in Patient-Controlled Intravenous Analgesia After Gynecological Tumor Operation: A Randomized Double-Blind Clinical Trial.,"Background


This study aims to compare analgesic effect and side effects of oxycodone and sufentanil in transition analgesia and patient-controlled intravenous analgesia (PCIA) after gynecological tumor operation under general anesthesia.
Patients and Methods


A prospective, randomized, double-blind research was conducted. Patients undergoing elective gynecological tumor surgery were randomized into four groups: Group S (sufentanil transition analgesia and sufentanil PCIA), Group OS (oxycodone transition analgesia and sufentanil PCIA), Group SO (sufentanil transition analgesia and oxycodone PCIA) and Group O (oxycodone transition analgesia and oxycodone PCIA). The primary outcomes were Numerical Rating Scale (NRS) at rest and coughing, accumulated opioid consumption in PCIA and patients' satisfaction.
Results


Patients in Group OS and Group O showed shorter time of consciousness recovery and extubation after surgery. Accumulated opioid consumption in PCIA (equal to morphine) in Group SO and Group O was significantly less than that in Group S and Group OS. Patients in Group O showed lower NRS at rest and coughing, but higher patients' satisfaction 3, 24 and 48 hours after surgery. Patients in Group SO and Group O showed a shorter time of intestinal recovery, first feeding and first-time movement.
Conclusion


Both oxycodone and sufentanil provided adequate pain relief in transitional analgesia and PCIA treatment after surgery. Oxycodone without background infusion showed less analgesic drug consumption and faster recovery than sufentanil with background infusion in PCIA after gynecological tumor operation under general anesthesia.",2020,Oxycodone without background infusion showed less analgesic drug consumption and faster recovery than sufentanil with background infusion in PCIA after gynecological tumor operation under general anesthesia.,"['transitional analgesia and PCIA treatment after surgery', 'Patient\ufeff-Controlled Intravenous Analgesia', 'transition analgesia and patient-controlled intravenous analgesia (PCIA) after gynecological tumor operation under general anesthesia', 'PCIA after gynecological tumor operation under general anesthesia', 'Patients undergoing elective gynecological tumor surgery']","['oxycodone and sufentanil', 'sufentanil', 'Oxycodone vs Sufentanil', 'Oxycodone without background infusion', 'Group S (sufentanil transition analgesia and sufentanil PCIA), Group OS (oxycodone transition analgesia and sufentanil PCIA), Group SO (sufentanil transition analgesia and oxycodone PCIA) and Group O (oxycodone transition analgesia and oxycodone PCIA', 'morphine']","['analgesic drug consumption and faster recovery', ""Numerical Rating Scale (NRS) at rest and coughing, accumulated opioid consumption in PCIA and patients' satisfaction"", 'shorter time of intestinal recovery, first feeding and first-time movement', 'shorter time of consciousness recovery and extubation', 'lower NRS at rest and coughing', 'adequate pain relief']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0427626', 'cui_str': 'Group O'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",,0.30439,Oxycodone without background infusion showed less analgesic drug consumption and faster recovery than sufentanil with background infusion in PCIA after gynecological tumor operation under general anesthesia.,"[{'ForeName': 'Sha-Jie', 'Initials': 'SJ', 'LastName': 'Dang', 'Affiliation': ""Department of Anesthesia, Shaanxi Provincial Cancer Hospital, Xi'an, Shaanxi, People's Republic of China.""}, {'ForeName': 'Rui-Li', 'Initials': 'RL', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesia, Shaanxi Provincial Cancer Hospital, Xi'an, Shaanxi, People's Republic of China.""}, {'ForeName': 'Wen-Bin', 'Initials': 'WB', 'LastName': 'Zeng', 'Affiliation': ""Department of Anesthesia, Shaanxi Provincial Cancer Hospital, Xi'an, Shaanxi, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Anesthesia, Shaanxi Provincial Cancer Hospital, Xi'an, Shaanxi, People's Republic of China.""}, {'ForeName': 'Hui-Yu', 'Initials': 'HY', 'LastName': 'Yue', 'Affiliation': ""Department of Anesthesia, Shaanxi Provincial Cancer Hospital, Xi'an, Shaanxi, People's Republic of China.""}, {'ForeName': 'Si-Yuan', 'Initials': 'SY', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesia, The Second Affiliated Hospital of Xian Jiaotong University, Xi'an, Shaanxi, People's Republic of China.""}, {'ForeName': 'Li-Chun', 'Initials': 'LC', 'LastName': 'Han', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Science and Technology, Xi'an Jiaotong University, Xi'an, Shaanxi, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S236933']
3018,31789307,Construction and Validation of Nomograms for Predicting Overall Survival and Cancer-Specific Survival in Nonmetastatic Inflammatory Breast Cancer Patients Receiving Tri-Modality Therapy: A Population-Based Study.,"BACKGROUND As the most aggressive breast cancer, inflammatory breast cancer (IBC) has a poor prognosis. However, analyzing the prognostic factors of IBC is challenging due to its rarity. We identified the prognostic factors to establish predictive tools for survival in nonmetastatic IBC patients who received tri-modality therapy. MATERIAL AND METHODS The data of 893 nonmetastatic IBC patients were acquired from the Surveillance, Epidemiology, and End Results (SEER) database. IBC was identified by ""ICD-O-3=8530"" or ""AJCC T, 7th=T4d""). Patients were randomized to the training (n=668) and validation (n=225) cohorts. Prognostic factors were identified in the training cohort. Factors in the nomogram for overall survival (OS) were filtered by the least absolute shrinkage selection operator (LASSO) regression model. Factors selected by the competing-risk models were integrated to construct nomograms for breast cancer-specific survival (BCSS). Nomogram validation was performed in both cohorts. RESULTS The number of positive lymph nodes contributed the most to both nomograms. In the validation cohort, the C-indexes for OS and BCSS were 0.724 and 0.727, respectively. Calibration curves demonstrated acceptable agreement between predicted and actual survival. Risk scores were calculated from the nomograms and used to split patients into the low-risk and high-risk groups. Smooth hazard ratio (HR) curves and Kaplan-Meier curves showed a statistically significant difference in prognosis between the high-risk group and low-risk group (log-rank P<0.001). CONCLUSIONS We unveiled the prognostic factors of nonmetastatic IBC and formulated nomograms to predict survival. In these models, the likelihood of individual survival can be easily calculated, which may assist clinicians in selecting treatment regimens.",2019,"In the validation cohort, the C-indexes for OS and BCSS were 0.724 and 0.727, respectively.","['nonmetastatic IBC patients who received tri-modality therapy', 'Nonmetastatic Inflammatory Breast Cancer Patients Receiving Tri-Modality Therapy', '893 nonmetastatic IBC patients']",[],"['Overall Survival and Cancer-Specific Survival', 'number of positive lymph nodes', 'overall survival (OS', 'Smooth hazard ratio (HR) curves and Kaplan-Meier curves', 'Risk scores', 'breast cancer-specific survival (BCSS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0278601', 'cui_str': 'Inflammatory Breast Cancer'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205357', 'cui_str': 'Smooth (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]",893.0,0.0261473,"In the validation cohort, the C-indexes for OS and BCSS were 0.724 and 0.727, respectively.","[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Tumor Surgery, Shantou Central Hospital, Affiliated Shantou Hospital of Sun Yat-sen University, Shantou, Guangdong, China (mainland).'}, {'ForeName': 'Teng-Yu', 'Initials': 'TY', 'LastName': 'Xu', 'Affiliation': 'Department of Urology Surgery, The Second Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, China (mainland).'}, {'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Wu', 'Affiliation': 'Department of Tumor Surgery, Shantou Central Hospital, Affiliated Shantou Hospital of Sun Yat-sen University, Shantou, Guangdong, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.919458']
3019,32440303,Effect of Intermittent Subglottic Irrigation with 5% NaCl on the Prevention of Ventilator Associated Pneumonia in Critically Ill Patients.,"Background


Ventilator-Associated Pneumonia (VAP) is one of the common causes of mortality and morbidity. Subglottic secretion suction decreases the incidence of VAP. In this study, the effect of 5% sodium chloride (NaCl) in subglottic area in addition to secretion suction in VAP prevention was investigated in patients who were admitted to the intensive care unit.
Materials and Methods


All patients were intubated by an intubation tube with subglottic suction. In the intervention group, subglottic area was washed with 10 ml of  5%  sodium chloride solution, and in the control group the subglottic area was washed with 10 ml distilled water. Patients were monitored for a maximum of two weeks, and the incidence of VAP was monitored by a Clinical Pulmonary Infection Score (CPIS).
Results


There was no significant difference between the two groups in terms of age and sex. Four (27%) patients in the intervention group, and 7 (37%) in control group were diagnosed with VAP, which was not statistically significant between the two groups (P=0.225). The duration of hospitalization, duration of intubation and mortality did not show any significant difference between the two groups.
Conclusion


It was expected that in this study the rate of VAP became significantly lower with the intervention of using antimicrobial solution in addition to suction. Although the rate decreased clinically, it was not statistically significant, which may be due to the low number of patients.",2019,"The duration of hospitalization, duration of intubation and mortality did not show any significant difference between the two groups.
","['Critically Ill Patients', 'patients who were admitted to the intensive care unit']","['intubation tube with subglottic suction', 'Intermittent Subglottic Irrigation with 5% NaCl', 'sodium chloride solution', 'Subglottic secretion suction', '5% sodium chloride (NaCl']","['incidence of VAP', 'duration of hospitalization, duration of intubation and mortality', 'rate of VAP', 'Clinical Pulmonary Infection Score (CPIS']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C1959973', 'cui_str': 'Percent sodium chloride'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0505448,"The duration of hospitalization, duration of intubation and mortality did not show any significant difference between the two groups.
","[{'ForeName': 'Taraneh', 'Initials': 'T', 'LastName': 'Naghibi', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Mosavi Educational Hospital, School of Medicine, Zanjan University of Medical Science, Zanjan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Akbari', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Mosavi Educational Hospital, School of Medicine, Zanjan University of Medical Science, Zanjan, Iran.'}, {'ForeName': 'Somayae', 'Initials': 'S', 'LastName': 'Abdollahi Sabet', 'Affiliation': 'Department of Community Medicine, School of Medicine, Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Dobakhti', 'Affiliation': 'School of Pharmacy, Zanjan University of Medical Science, Zanjan, Iran.'}]",Tanaffos,[]
3020,32440610,Pain inhibition is not affected by exercise-induced pain.,"Introduction


Offset analgesia (OA) and conditioned pain modulation (CPM) are frequently used paradigms to assess the descending pain modulation system. Recently, it was shown that both paradigms are reduced in chronic pain, but the influence of acute pain has not yet been adequately examined.
Objectives


The aim of this study is to investigate OA and CPM after exercise-induced pain to evaluate whether these tests can be influenced by delayed-onset muscle soreness (DOMS) at a local or remote body site.
Methods


Forty-two healthy adults were invited to 3 separate examination days: a baseline appointment, the consecutive day, and 7 days later. Participants were randomly divided into a rest (n = 21) and an exercise group (n = 21). The latter performed a single intensive exercise for the lower back. Before, immediately after, and on the following examination days, OA and CPM were measured at the forearm and the lower back by blinded assessor.
Results


The exercise provoked a moderate pain perception and a mild delayed-onset muscle soreness on the following day. Repeated-measurements analysis of variance showed no statistically significant main effect for either OA or CPM at the forearm or lower back ( P  > 0.05).
Conclusion


Delayed-onset muscle soreness was shown to have no effect on the inhibitory pain modulation system neither locally (at the painful body part), nor remotely. Thus, OA and CPM are robust test paradigms that probably require more intense, different, or prolonged pain to be modulated.",2020,"Repeated-measurements analysis of variance showed no statistically significant main effect for either OA or CPM at the forearm or lower back ( P  > 0.05).
",['Methods\n\n\nForty-two healthy adults'],"['exercise group', 'Introduction\n\n\nOffset analgesia (OA) and conditioned pain modulation (CPM']","['moderate pain perception', 'OA and CPM', 'chronic pain', 'Pain inhibition']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",42.0,0.0707934,"Repeated-measurements analysis of variance showed no statistically significant main effect for either OA or CPM at the forearm or lower back ( P  > 0.05).
","[{'ForeName': 'Tibor M', 'Initials': 'TM', 'LastName': 'Szikszay', 'Affiliation': 'Department of Health Sciences, Academic Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Waclaw M', 'Initials': 'WM', 'LastName': 'Adamczyk', 'Affiliation': 'Department of Health Sciences, Academic Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wojtyna', 'Affiliation': 'Institute of Psychology, University of Silesia, Katowice, Katowice, Poland.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luedtke', 'Affiliation': 'Department of Health Sciences, Academic Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), University of Luebeck, Luebeck, Germany.'}]",Pain reports,['10.1097/PR9.0000000000000817']
3021,32440127,The Effect of Perceptual-Motor Training on Executive Functions in Children with Non-Verbal Learning Disorder.,"Purpose


Research shows an atypical cognitive process in children with nonverbal learning disorder (NLD) compared to typically developing children, but a wealth of information indicates that physical activity can influence cognitive processes. However, little is known about the effects of perceptual-motor training and its impact on the cognitive process of children with NLD. Thus, the major goals of this study are to compare the executive functions (EFs) in children with NLD with typically developing children and then to investigate the effect of perceptual-motor training on EFs of children with NLD.
Methods


To achieve the first goal, 400 typically developing (IQ >80) and NLD children (7-13 years old) were randomly selected in the city of Mashhad, Iran, during the period 2017-2018. As for the second goal, 50 children with NLD were randomly assigned to an experimental or control group. To evaluate executive functions, Delis-Kaplan executive function system test was used at the pretest, posttest, and 3-month follow-up. The experimental group received the Werner and Reini's perceptual-motor training program in sixteen 45-min sessions (three sessions per week), but the control group did not receive any intervention.
Results


The results showed that children with NLD were significantly weaker than typically developing children in London Tower Test (t (38) = -4.662, p <0.01), Trail Making Test (t (33.926) = -3.11, p <0.01), Card Sorting Test (t (38) = -3.427, p <0.01), and Stroop Color Test (t (30.035) = -5.876, p <0.01). The Pilates training had an obvious effect on enhancing the performance of participants in the experimental group (p<0.001), but similar results were not observed in the control group.
Conclusion


Children with NLD have problems in EFs, but perceptual-motor training can be used as an effective intervention for these children.",2020,"The Pilates training had an obvious effect on enhancing the performance of participants in the experimental group (p<0.001), but similar results were not observed in the control group.
","['Children with Non-Verbal Learning Disorder', 'children with \ufeffnonverbal \ufefflearning \ufeffdisorder (NLD', '50 children with NLD', 'children with NLD', 'children with NLD with typically developing children', '400 typically developing (IQ >80) and NLD children (7-13 years old) were randomly selected in the city of Mashhad, Iran, during the period 2017-2018']","['control group did not receive any intervention', ""Werner and Reini's perceptual-motor training program"", 'perceptual-motor training', 'Perceptual-Motor Training']",['Executive Functions'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043119', 'cui_str': 'Werner syndrome'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}]",50.0,0.0130184,"The Pilates training had an obvious effect on enhancing the performance of participants in the experimental group (p<0.001), but similar results were not observed in the control group.
","[{'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Soltani Kouhbanani', 'Affiliation': 'Department of Educational Sciences, Educational Sciences and Psychology Faculty, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Seyedeh Manizheh', 'Initials': 'SM', 'LastName': 'Arabi', 'Affiliation': 'Department of Motor Behavior, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Zarenezhad', 'Affiliation': 'Department of Educational Sciences, Educational Sciences and Psychology Faculty, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Khosrorad', 'Affiliation': 'Department of Health Education, Educational Neuroscience Research Center, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Neuropsychiatric disease and treatment,['10.2147/NDT.S252662']
3022,32440294,"Letter to the Editor on ""Analgesic Effects of Ketamine, Magnesium Sulfate, and Sodium-Thiopental on Propofol Injection Pain: A Single-Blind Randomized Clinical Trial"".",,2019,,[],"['Ketamine, Magnesium Sulfate, and Sodium-Thiopental']",['Propofol Injection Pain'],[],"[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0936073', 'cui_str': 'Thiopental sodium'}]","[{'cui': 'C4282968', 'cui_str': 'Propofol Injection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0994096,,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Aminnejad', 'Affiliation': 'Department of Anesthesiology & Critical Care, Qom University of Medical Sciences, Qom, Iran, Department of Pain Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Tanaffos,[]
3023,32440337,Efficacy of L-carnitine and propranolol in the management of acute theophylline toxicity.,"Theophylline toxicity results in substantial morbidity and mortality particularly due to its narrow therapeutic index. The development of new treatments for acute theophylline toxicity is a point of research interest. The aim of the present work was to assess the efficacy of L-carnitine (LC) and propranolol in the management of patients with acute theophylline toxicity. The study was conducted on 60 patients with acute theophylline toxicity admitted to the Poison Control Center or Intensive Care Unit at Alexandria Main University Hospital. The studied patients were equally classified into four groups (GPs, 15 patients each): the first group was the control group who received standard treatment protocol for theophylline toxicity. The other three GPs also received standard treatment protocol for theophylline toxicity in addition. The second group (LC group) received LC with a loading dose of 100 mg/kg IV over 30-60 min (maximum 6 g) and the maintenance dose was 50 mg/kg IV every 8 h. The third group (propranolol group) received propranolol, administered slowly intravenous 0.5-1 mg over 1 min; it may be repeated if necessary up to a total maximum dose of 0.1 mg/kg. The fourth group (propranolol and LC) received both IV propranolol and LC in the same doses as previous. Treatment with LC alone or in combination with propranolol resulted in a significant improvement of both clinical and laboratory findings. Although combined therapy yields the best results and outcome, LC can serve as an antidote for acute theophylline toxicity if there is any contraindication to propranolol administration.",2020,Treatment with LC alone or in combination with propranolol resulted in a significant improvement of both clinical and laboratory findings.,"['patients with acute theophylline toxicity', '60 patients with acute theophylline toxicity admitted to the Poison Control Center or Intensive Care Unit at Alexandria Main University Hospital']","['propranolol and LC', 'Theophylline toxicity', 'L-carnitine and propranolol', 'standard treatment protocol for theophylline toxicity', 'LC', 'L-carnitine (LC) and propranolol', 'propranolol']",['acute theophylline toxicity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0274770', 'cui_str': 'Poisoning by theophylline'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0032340', 'cui_str': 'Centers, Poison Control'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0274770', 'cui_str': 'Poisoning by theophylline'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0274770', 'cui_str': 'Poisoning by theophylline'}]",60.0,0.0141716,Treatment with LC alone or in combination with propranolol resulted in a significant improvement of both clinical and laboratory findings.,"[{'ForeName': 'Naima A', 'Initials': 'NA', 'LastName': 'Sherif', 'Affiliation': 'Department of Forensic Medicine& Clinical Toxicology-Faculty of Medicine, Alexandria University, Egypt.'}, {'ForeName': 'Asmaa S', 'Initials': 'AS', 'LastName': 'El-Banna', 'Affiliation': 'Department of Forensic Medicine& Clinical Toxicology-Faculty of Medicine, Alexandria University, Egypt.'}, {'ForeName': 'Marwan M', 'Initials': 'MM', 'LastName': 'ElBourini', 'Affiliation': 'Critical Care Medicine, Faculty of Medicine, Alexandria University, Egypt.'}, {'ForeName': 'Nancy O', 'Initials': 'NO', 'LastName': 'Khalil', 'Affiliation': 'Department of Forensic Medicine& Clinical Toxicology-Faculty of Medicine, Alexandria University, Egypt.'}]",Toxicology research,['10.1093/toxres/tfaa002']
3024,32440585,Reduction of Distress Intolerance With Salutotherapeutic Interventions: Results From a Randomized Controlled Clinical Trial.,"Background


Distress tolerance is the ability to pursue one's goals in the presence of (chronic) stressors, hardship, adversities and negative internal states, and psychological distress. By contrast, distress intolerance is a transdiagnostic indicator of mental illness and a mediator in coping with problems in life, work demands, or stress in general. There is a lack of data regarding intervention strategies. The objective of the present study is to test the differential effects of two treatment approaches: ""regeneration fostering"" versus ""resistance training.""
Methods


Inpatients of a psychosomatic hospital were randomly allocated to either a resistance training group therapy ( n  = 65)-that is, active coping with demands and endurance-or a regeneration fostering group therapy ( n  = 62)-that is, recovery, mindful indulgence, and creative activities. They were compared with a group of patients who received treatment as usual ( n  = 43), without special treatments for distress intolerance, and the outcome was measured with the ""Distress Intolerance Scale."" One-way and repeated measure analyses of variance and paired  t  tests were used for the analysis.
Results


The ""regeneration"" group showed a significant improvement in distress intolerance, whereas there was no significant change for the treatment-as-usual group and in the ""resistance"" group. Post hoc tests were conducted with paired sample  t  tests for pre-post comparisons for each group. No differences were found for the treatment-as-usual group ( mean difference : 0.03,  SD  (mean difference): 0.89;  t (42) = 0.266,  p  = 0.792,  d  = 0.04) and for the resistance group ( mean difference :-0.07,  SD  (mean difference): 0.73;  t (63) = -0.736,  p  = 0.464,  d  = 0.08). The regeneration group showed a significant decline in distress intolerance ( mean difference : 0.29,  SD  (mean difference): 0.72;  t (61) = 3.156,  p  = 0.002,  d  = 0.38).
Conclusions


In the treatment of distress intolerance, it seems promising to focus on positive psychology interventions and resources. Limitations of the study are that it was conducted with psychosomatic inpatients only and that no follow-up data are available.",2018,"The regeneration group showed a significant decline in distress intolerance ( mean difference : 0.29,  SD  (mean difference): 0.72;  t (61) = 3.156,  p  = 0.002,  d  = 0.38).
",['Methods\n\n\nInpatients of a psychosomatic hospital'],"['resistance training group therapy ( n \u2009=\u200965)-that is, active coping with demands and endurance-or a regeneration fostering group therapy', 'regeneration fostering"" versus ""resistance training', 'Salutotherapeutic Interventions']","['Distress Intolerance Scale', 'distress intolerance', 'Distress Intolerance']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.119477,"The regeneration group showed a significant decline in distress intolerance ( mean difference : 0.29,  SD  (mean difference): 0.72;  t (61) = 3.156,  p  = 0.002,  d  = 0.38).
","[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Otto', 'Affiliation': 'Research Group Psychosomatic Rehabilitation, Charié University Medicine, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Linden', 'Affiliation': 'Research Group Psychosomatic Rehabilitation, Charié University Medicine, Berlin, Germany.'}]","Chronic stress (Thousand Oaks, Calif.)",['10.1177/2470547018800484']
3025,32440638,"Anemia and Micronutrient Status during Pregnancy, and Their Associations with Obstetric and Infant Outcomes among HIV-Infected Ugandan Women Receiving Antiretroviral Therapy.","Background


Women living with HIV (WLHIV) are at higher risk of micronutrient deficiencies and adverse health outcomes. There are limited data on the burden or sequelae of micronutrient deficiencies among pregnant WLHIV receiving antiretroviral therapy (ART).
Objectives


We aimed to examine anemia and vitamin B-12, folate, and vitamin D deficiencies, and their associations with obstetric and infant outcomes, among pregnant WLHIV initiating combination antiretroviral therapy (cART) in rural Uganda.
Methods


This was a prospective analysis among pregnant WLHIV (12-28 weeks of gestation) in PROMOTE-Pregnant Women and Infants (PIs), a randomized trial comparing the effects of protease inhibitor (PI)-based ART with those of a non-PI-based ART on placental malaria risk. We conducted a substudy on the burden of anemia [trimester 1/3: hemoglobin (Hb) <11.0 g/dL; trimester 2: Hb <10.5 g/dL;  n  = 367] and micronutrient deficiencies ( n  = 127) in pregnant WLHIV and their associations with obstetric and infant outcomes. Hb was measured by cyanmethemoglobin, vitamin B-12 and folate were measured via electrochemiluminescence, and vitamin D was measured by ELISA. Linear and binomial regression were used to evaluate associations between micronutrient status during pregnancy and perinatal outcomes.
Results


26.8% women were anemic, 30.2% were vitamin B-12 insufficient (<221.0 pmol/L), 66.1% were folate insufficient (<13.5 nmol/L), and 65.4% were vitamin D insufficient (<30.0 ng/mL) at enrollment. Anemia during pregnancy was associated with a greater risk of small for gestational age (SGA) (RR: 1.88; 95% CI: 1.28, 2.77;  P  = 0.001); each 1-g/dL decrease in Hb was associated with greater risk of SGA (RR: 0.76; 95% CI: 0.65, 0.90;  P  = 0.001). Multivariate models showed that increased vitamin D concentrations predicted lower risk of infant wasting (WLZ < -2; RR: 0.94; 95% CI: 0.89, 0.99;  P  = 0.04). Multivariate models also indicated that maternal vitamin B-12 and folate concentrations at enrollment predicted maternal ( P  < 0.001) and infant ( P  = 0.02) concentrations postpartum.
Conclusions


Anemia and micronutrient deficiencies are associated with a variety of adverse obstetric and infant outcomes and are an important public health concern in perinatal WLHIV on cART and their children.This trial was registered at clinicaltrials.gov as NCT00993031.",2020,"Anemia during pregnancy was associated with a greater risk of small for gestational age (SGA) (RR: 1.88; 95% CI: 1.28, 2.77;  P  = 0.001); each 1-g/dL decrease in Hb was associated with greater risk of SGA (RR: 0.76; 95% CI: 0.65, 0.90;  P  = 0.001).","['anemia [trimester 1/3: hemoglobin (Hb)\xa0<11.0 g/dL; trimester 2', 'pregnant WLHIV receiving antiretroviral therapy (ART', 'pregnant WLHIV (12-28 weeks of gestation) in PROMOTE-Pregnant Women and Infants (PIs', 'HIV-Infected Ugandan Women Receiving Antiretroviral Therapy', '\n\n\nWomen living with HIV (WLHIV']","['protease inhibitor (PI)-based ART with those of a non-PI-based ART', 'pregnant WLHIV initiating combination antiretroviral therapy (cART']","['cyanmethemoglobin, vitamin B-12 and folate were measured via electrochemiluminescence, and vitamin D', 'maternal vitamin B-12 and folate concentrations', 'Anemia']","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0056663', 'cui_str': 'Cyanmethemoglobin'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",367.0,0.327726,"Anemia during pregnancy was associated with a greater risk of small for gestational age (SGA) (RR: 1.88; 95% CI: 1.28, 2.77;  P  = 0.001); each 1-g/dL decrease in Hb was associated with greater risk of SGA (RR: 0.76; 95% CI: 0.65, 0.90;  P  = 0.001).","[{'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Finkelstein', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Heather S', 'Initials': 'HS', 'LastName': 'Herman', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Plenty', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Natureeba', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Ruel', 'Affiliation': ""Division of Infectious Disease, Department of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA, USA.""}, {'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Charlebois', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cohan', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Havlir', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sera L', 'Initials': 'SL', 'LastName': 'Young', 'Affiliation': 'Department of Anthropology and Global Health Studies, Northwestern University, Evanston, IL, USA.'}]",Current developments in nutrition,['10.1093/cdn/nzaa075']
3026,31082269,NAB-Paclitaxel Improves Disease-Free Survival in Early Breast Cancer: GBG 69-GeparSepto.,"PURPOSE


The GeparSepto trial demonstrated that weekly nanoparticle albumin-bound (NAB)-paclitaxel significantly improves the pathologic complete remission rate compared with weekly solvent-based (sb) paclitaxel followed by epirubicin plus cyclophosphamide as neoadjuvant treatment in patients with primary breast cancer (BC). Here, we report data on long-term outcomes.
METHODS


Patients with histologically confirmed primary BC were randomly assigned in a 1:1 ratio to 12 times weekly NAB-paclitaxel 150 mg/m 2  (after study amendment, 125 mg/m 2 ) or weekly sb-paclitaxel 80 mg/m 2  followed in both arms by four times epirubicin 90 mg/m 2  plus cyclophosphamide 600 mg/m 2  every 3 weeks. Patients with human epidermal growth factor receptor 2 (HER2)-positive BC received dual antibody treatment with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) and pertuzumab (840 mg loading dose followed by 420 mg every 3 weeks) concurrently to chemotherapy and continued for 1 year.
RESULTS


A total of 1,206 patients started treatment, 606 with NAB-paclitaxel and 600 with sb-paclitaxel. After a median follow-up of 49.6 months (range, 0.5 to 64.0 months), 243 invasive disease-free survival (iDFS) events were reported (143 in the sb-paclitaxel and 100 in the NAB-paclitaxel arm). At 4 years, overall patients treated with NAB-paclitaxel had a significantly better iDFS compared with sb-paclitaxel (84.0%  v  76.3%; hazard ratio, 0.66; 95% CI, 0.51 to 0.86;  P  = .002), whereas overall survival did not significantly differ between the two treatment arms (89.7%  v  87.2%, respectively; hazard ratio, 0.82; 95% CI, 0.59 to 1.16;  P  = .260). Long-term follow-up of the treatment-related peripheral sensory neuropathy (PSN) showed a significant decrease of the median time to resolve PSN after NAB-paclitaxel 125 mg/m 2  compared with NAB-paclitaxel 150 mg/m 2 .
CONCLUSION


The significantly higher pathologic complete response rate with NAB-paclitaxel translated into a significantly improved iDFS in patients with early BC as compared with sb-paclitaxel. PSN improved much faster under NAB-paclitaxel 125 mg/m 2  compared with NAB-paclitaxel 150 mg/m 2 .",2019,"At 4 years, overall patients treated with NAB-paclitaxel had a significantly better iDFS compared with sb-paclitaxel (84.0%  v  76.3%; hazard ratio, 0.66; 95% CI, 0.51 to 0.86;  P  = .002), whereas overall survival did not significantly differ between the two treatment arms (89.7%  v  87.2%, respectively; hazard ratio, 0.82; 95% CI, 0.59 to 1.16;  P  = .260).","['patients with primary breast cancer (BC', 'Early Breast Cancer', 'Patients with histologically confirmed primary BC', '1,206 patients started treatment, 606 with', 'Patients with human epidermal growth factor receptor 2 (HER2)-positive BC received']","['nanoparticle albumin-bound (NAB)-paclitaxel', 'dual antibody treatment with trastuzumab', 'sb-paclitaxel 80 mg/m 2  followed in both arms by four times epirubicin 90 mg/m 2  plus cyclophosphamide', 'NAB-paclitaxel and 600 with sb-paclitaxel', 'pertuzumab', 'sb-paclitaxel', 'NAB-paclitaxel', 'solvent-based (sb) paclitaxel followed by epirubicin plus cyclophosphamide', 'NAB-Paclitaxel']","['pathologic complete remission rate', '243 invasive disease-free survival (iDFS) events', 'median time to resolve PSN', 'overall survival', 'iDFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C1961039', 'cui_str': 'paclitaxel protein-bound'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms (body structure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0037638', 'cui_str': 'Solvents'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1206.0,0.0837363,"At 4 years, overall patients treated with NAB-paclitaxel had a significantly better iDFS compared with sb-paclitaxel (84.0%  v  76.3%; hazard ratio, 0.66; 95% CI, 0.51 to 0.86;  P  = .002), whereas overall survival did not significantly differ between the two treatment arms (89.7%  v  87.2%, respectively; hazard ratio, 0.82; 95% CI, 0.59 to 1.16;  P  = .260).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum, Offenbach, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'Nationales Centrum für Tumorerkrankungen, Heidelberg, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schmatloch', 'Affiliation': 'St Elisabeth Krankenhaus Kassel, Kassel, Germany.'}, {'ForeName': 'Bahriye', 'Initials': 'B', 'LastName': 'Aktas', 'Affiliation': 'Klinik und Poliklinik für Frauenheilkunde Leipzig, Leipzig, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schem', 'Affiliation': 'Universitätsklinikum Kiel, Kiel, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Wiebringhaus', 'Affiliation': 'St Barbara-Klinik Hamm-Heessen, Hamm, Germany.'}, {'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kümmel', 'Affiliation': 'Interdisziplinäres Brustzentrum an den Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Warm', 'Affiliation': 'Brustzentrum im Krankenhaus Köln-Holweide, Cologne, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Universitätsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Just', 'Affiliation': 'Onkologische Schwerpunktpraxis Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': 'Klinikum zum Roten Kreuz, Munich, Germany.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hackmann', 'Affiliation': 'Marien Hospital Witten, Witten, Germany.'}, {'ForeName': 'Jens-Uwe', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Klinik für Gynäkologie am Campus Charité Mitte, Berlin, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Rhiem', 'Affiliation': 'Uniklinik Köln, Cologne, Germany.'}, {'ForeName': 'Wolfgang D', 'Initials': 'WD', 'LastName': 'Schmitt', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Furlanetto', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': 'Universitäts-Frauenklinik, Rostock, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01842']
3027,32440639,Findings of a Pilot Study Investigating the Effects of Mediterranean Diet and Aerobic Exercise on Cognition in Cognitively Healthy Older People Living Independently within Aged-Care Facilities: The Lifestyle Intervention in Independent Living Aged Care (LIILAC) Study.,"Background


Cognitive decline and Alzheimer disease are more prevalent in our aging population. Modifiable risk factors, such as diet and sedentary lifestyle, have been proposed as key to potentially ameliorating cognitive decline. Both exercise and Mediterranean diet (MedDiet) have been linked to reduced levels of cardiovascular disease and other comorbidities. Higher levels of exercise and MedDiet adherence may prove to be cognitively protective, both individually and synergistically.
Objectives


The aim was to investigate the effect of a 6-mo program of MedDiet, exercise, and a combination of both, on cognition, mood, and general health in older persons living independently in aged-care communities.
Methods


The Lifestyle Intervention in Independent Living Aged Care (LIILAC) Study (ACTRN12614001133628) involved 102 participants, aged 60-90 y, who were randomly assigned to 1 of 4 intervention groups. Change in overall memory performance was assessed as the primary outcome. Additionally, changes in cognitive task performance, as well as mood, wellness, cardiovascular function, and blood biomarkers, were investigated.
Results


While there was no significant change in overall memory performance, there was a significant improvement in spatial working memory performance in the combined exercise and diet group, relative to controls. This combined intervention group also showed an overall improvement in their emotional state, as assessed by the Depression Anxiety Stress Scale, as did the exercise-only group.
Conclusions


This research indicates that diet and exercise programs have the potential to improve aspects of cognition and mood in an aging population. However, given the lower than optimal sample size and lack of resources to reinforce the interventions during the trial, further larger randomized controlled trials are required to substantiate whether the introduction of diet and exercise programs into independent-living facilities is a viable method to preserve cognitive health in older people. This trial was registered at www.ANZCTR.org.au ACTRN 12614001133628 (LIILAC Study).",2020,"This combined intervention group also showed an overall improvement in their emotional state, as assessed by the Depression Anxiety Stress Scale, as did the exercise-only group.
","['older persons living independently in aged-care communities', 'older people', 'Cognitively', '102 participants, aged 60-90 y', 'Healthy Older People Living']","['Lifestyle Intervention', 'exercise and Mediterranean diet (MedDiet', 'Mediterranean Diet and Aerobic Exercise']","['Depression Anxiety Stress Scale', 'overall memory performance', 'cognitive task performance, as well as mood, wellness, cardiovascular function, and blood biomarkers', 'spatial working memory performance', 'overall improvement in their emotional state']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0303596', 'cui_str': 'Yttrium-90'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}]",102.0,0.0557553,"This combined intervention group also showed an overall improvement in their emotional state, as assessed by the Depression Anxiety Stress Scale, as did the exercise-only group.
","[{'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Hardman', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Denny', 'Initials': 'D', 'LastName': 'Meyer', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Kennedy', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Macpherson', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Scholey', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pipingas', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Melbourne, Australia.'}]",Current developments in nutrition,['10.1093/cdn/nzaa077']
3028,32440640,A comparative study on efficacy of fixed combination timolol/brinzolamide versus travoprost monotherapy in drug-naïve open-angle glaucoma patients.,"Background


Glaucoma is most common irreversible cause of blindness in India. First line management of open-angle glaucoma is either beta blockers or prostaglandin analogs monotherapy. Monotherapy rarely achieves target intraocular pressure within 2 years and patients are shifted to combination medications, usually fixed-dose combination.
Objective


To compare travoprost monotherapy and timolol/brinzolamide fixed-dose combination for their intraocular pressure lowering efficacy, their effects on hemodynamic parameters and cup disc ratio reversibility in newly diagnosed drug-naïve open-angle glaucoma patients.
Material and methods


In a 12-week, prospective, randomised, single-blind study, patients were randomised to receive twice daily 0.5% timolol and 0.2% brinzolamide fixed-dose combination (n = 52) or once daily travoprost 0.004% (n = 52). Intraocular pressure, blood pressure, pulse rate and cup disc ratio were compared across treatment groups over 3 months.
Results


Significant reduction ( p  < 0.001) in intraocular pressure by 27.99% and 30.49% at 12th-week visit as compared with baseline was observed in monotherapy and fixed-dose combination group, respectively. Significant changes in pulse rate (9 beats/min) and systolic blood pressure (2.35 mmHg) was observed in fixed-dose combination group. No cup disc ratio reversibility was observed at the end of study. Conjunctival hyperaemia ( n  = 14) and transient blurring of vision ( n  = 16) were most commonly reported adverse drug reaction in monotherapy and fixed-dose combination, respectively.
Conclusion


The 0.5% timolol and 0.2% brinzolamide fixed-dose combination produced greater reduction in intraocular pressure than those produced by 0.004% travoprost alone in drug-naïve open-angle glaucoma patients.",2020,"Results


Significant reduction ( p  < 0.001) in intraocular pressure by 27.99% and 30.49% at 12th-week visit as compared with baseline was observed in monotherapy and fixed-dose combination group, respectively.","['drug-naïve open-angle glaucoma patients', 'newly diagnosed drug-naïve open-angle glaucoma patients']","['Monotherapy', 'timolol/brinzolamide fixed-dose combination', 'prostaglandin analogs monotherapy', 'timolol and 0.2% brinzolamide fixed-dose combination', 'timolol', 'fixed combination timolol/brinzolamide versus travoprost monotherapy']","['hemodynamic parameters and cup disc ratio reversibility', 'Intraocular pressure, blood pressure, pulse rate and cup disc ratio', 'transient blurring of vision', 'pulse rate', 'adverse drug reaction', 'Conjunctival hyperaemia', 'systolic blood pressure', 'cup disc ratio reversibility', 'intraocular pressure']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0673966', 'cui_str': 'brinzolamide'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0033568', 'cui_str': 'Prostaglandin analog'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C3653114', 'cui_str': 'timolol, combinations'}, {'cui': 'C0937916', 'cui_str': 'travoprost'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0423471', 'cui_str': 'Optic cup/disc ratio'}, {'cui': 'C0449261', 'cui_str': 'Reversibility'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.186782,"Results


Significant reduction ( p  < 0.001) in intraocular pressure by 27.99% and 30.49% at 12th-week visit as compared with baseline was observed in monotherapy and fixed-dose combination group, respectively.","[{'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Dixit', 'Affiliation': 'Department of Pharmacology, Uttar Pradesh University of Medical Sciences, Saifai, India.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Ashish', 'Affiliation': 'Department of Pharmacology, Uttar Pradesh University of Medical Sciences, Saifai 206130, Etawah, Uttar Pradesh, India.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Ophthalmology, Uttar Pradesh University of Medical Sciences, Saifai, India.'}]",Therapeutic advances in ophthalmology,['10.1177/2515841420909666']
3029,32440646,Uncommitted Commitment: Behavioral Strategy to Prevent Preference Reversals.,"When both smaller-sooner (SS) and larger-later (LL) rewards are temporally distal, individuals frequently prefer the LL. However, because both outcomes become proximal, individuals frequently switch to preferring the SS. These preference reversals are predicted by hyperbolic delay discounting, and may model the essential challenge of self-control. Using smokers, a population known to have high rates of delay discounting, and thus more vulnerable to preference reversals, this pilot study sought to examine  soft commitment  as a strategy that may prevent preference reversals. Eleven smokers were assigned to an experimental commitment condition, operationalized as 3 weeks of daily commitment trials indicating preference between an SS and LL. Ten smokers were assigned to a control commitment condition. These 3 weeks were followed by 8 days of daily choice trials indicating preference between an impending SS and LL, for both experimental and control conditions. Though no overall difference of preference was observed between groups during the choice trials, hierarchical linear modeling revealed a decrease in preference for the LL over time by the control group (e.g., increasing trend of preference reversals) but no changes by the experimental group. This pilot study provides an initial indication that soft commitment can facilitate choice persistence and prevent preference reversals.",2020,"Though no overall difference of preference was observed between groups during the choice trials, hierarchical linear modeling revealed a decrease in preference for the LL over time by the control group (e.g., increasing trend of preference reversals) but no changes by the experimental group.",['Eleven smokers'],[],[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}]",[],[],11.0,0.0233431,"Though no overall difference of preference was observed between groups during the choice trials, hierarchical linear modeling revealed a decrease in preference for the LL over time by the control group (e.g., increasing trend of preference reversals) but no changes by the experimental group.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Yi', 'Affiliation': '1Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, KS 66045 USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Milhorn', 'Affiliation': '2University of Maryland, College Park, MD USA.'}, {'ForeName': 'Anahi', 'Initials': 'A', 'LastName': 'Collado', 'Affiliation': '1Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, KS 66045 USA.'}, {'ForeName': 'Kayla N', 'Initials': 'KN', 'LastName': 'Tormohlen', 'Affiliation': '3Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD USA.'}, {'ForeName': 'Jama', 'Initials': 'J', 'LastName': 'Bettis', 'Affiliation': '1Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, KS 66045 USA.'}]",Perspectives on behavior science,['10.1007/s40614-019-00229-8']
3030,31464558,"Immunogenicity and safety of a dengue vaccine given as a booster in Singapore: a randomized Phase II, placebo-controlled trial evaluating its effects 5-6 years after completion of the primary series.","The tetravalent dengue vaccine (CYD-TDV; Dengvaxia®) is administered on a three-dose schedule, 6 months apart in those aged ≥9 years in a number of dengue-endemic countries in Asia and Latin America. In this study, CYD63 (NCT02824198), participants aged 9-45 years at first vaccination, and who had received three doses of CYD-TDV in the CYD28 study more than 5 years previously, were randomized 3:1 to receive a booster CYD-TDV dose (Group 1) or placebo (Group 2). Dengue neutralizing antibody geometric mean titres (PRNT 50  GMTs) for each of the four dengue serotypes were assessed in sera collected before and 28 days after booster injections. Non-inferiority of the booster immune response versus that induced after the third dose was demonstrated for each serotype if the lower limit of the two-sided 95% confidence interval (CI) was >0.5 for the GMT ratios (GMTRs) between post-booster CYD-TDV dose and post-dose 3 in Group 1. Overall, 118 participants received CYD-TDV booster or placebo and 116 (98.3%) completed the study; two participants were withdrawn because of noncompliance. GMTs in the booster CYD-TDV group increased across all serotypes post-booster injection by 1.74- (serotype 1) to 3.58-fold (serotype 4). No discernible increases were observed in the placebo group. Non-inferiority was demonstrated for serotypes 1, 3, and 4, but not for serotype 2 (GMTR; 0.603 [95% CI, 0.439- 0.829]). No safety issues were observed. These data show that the CYD-TDV booster given 5 or more years later tended to restore GMTs back to levels observed post-dose 3.",2020,"Non-inferiority was demonstrated for serotypes 1, 3 and 4, but not for serotype 2","['118 participants received', 'aged ≥9 years in a number of dengue-endemic countries in Asia and Latin America', 'Singapore', 'participants aged 9-45 years at first vaccination, and who had received three doses of CYD-TDV in the CYD28']","['booster CYD-TDV', 'dengue vaccine', 'CYD-TDV booster or placebo', 'placebo', 'vaccine (CYD-TDV; Dengvaxia®', 'GMTR']",['Immunogenicity and safety'],"[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",118.0,0.498568,"Non-inferiority was demonstrated for serotypes 1, 3 and 4, but not for serotype 2","[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Clinical Research and Development, Sanofi Pasteur, Singapore.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Archuleta', 'Affiliation': 'Division of Infectious Diseases, University Medicine Cluster, National University Hospital, Singapore.'}, {'ForeName': 'May-Lin Helen', 'Initials': 'MH', 'LastName': 'Oh', 'Affiliation': 'Department of Medicine, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Lynette Pei-Chi', 'Initials': 'LP', 'LastName': 'Shek', 'Affiliation': 'Department of Pediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Biostatistics, Sanofi, Beijing, China.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bonaparte', 'Affiliation': 'Global Clinical Immunology department, Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Fargo', 'Affiliation': 'Clinical Research and Development, Sanofi Pasteur, Singapore.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Bouckenooghe', 'Affiliation': 'Clinical Research and Development, Sanofi Pasteur, Singapore.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1661204']
3031,31194613,Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Treatment of Stage IIIA-N2  EGFR -Mutant Non-Small-Cell Lung Cancer (EMERGING-CTONG 1103): A Randomized Phase II Study.,"PURPOSE


To assess the benefits of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors as neoadjuvant/adjuvant therapies in locally advanced  EGFR  mutation-positive non-small-cell lung cancer.
PATIENTS AND METHODS


This was a multicenter (17 centers in China), open-label, phase II, randomized controlled trial of erlotinib versus gemcitabine plus cisplatin (GC chemotherapy) as neoadjuvant/adjuvant therapy in patients with stage IIIA-N2 non-small-cell lung cancer with  EGFR  mutations in exon 19 or 21 (EMERGING). Patients received erlotinib 150 mg/d (neoadjuvant therapy, 42 days; adjuvant therapy, up to 12 months) or gemcitabine 1,250 mg/m 2  plus cisplatin 75 mg/m 2  (neoadjuvant therapy, two cycles; adjuvant therapy, up to two cycles). Assessments were performed at 6 weeks and every 3 months postsurgery. The primary end point was objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; secondary end points were pathologic complete response, progression-free survival (PFS), overall survival, safety, and tolerability.
RESULTS


Of 386 patients screened, 72 were randomly assigned to treatment (intention-to-treat population), and 71 were included in the safety analysis (one patient withdrew before treatment). The ORR for neoadjuvant erlotinib versus GC chemotherapy was 54.1% versus 34.3% (odds ratio, 2.26; 95% CI, 0.87 to 5.84;  P  = .092). No pathologic complete response was identified in either arm. Three (9.7%) of 31 patients and zero of 23 patients in the erlotinib and GC chemotherapy arms, respectively, had a major pathologic response. Median PFS was significantly longer with erlotinib (21.5 months) versus GC chemotherapy (11.4 months; hazard ratio, 0.39; 95% CI, 0.23 to 0.67;  P  < .001). Observed adverse events reflected those most commonly seen with the two treatments.
CONCLUSION


The primary end point of ORR with 42 days of neoadjuvant erlotinib was not met, but the secondary end point PFS was significantly improved.",2019,"Median PFS was significantly longer with erlotinib (21.5 months) versus GC chemotherapy (11.4 months; hazard ratio, 0.39; 95% CI, 0.23 to 0.67;  P  < .001).","['multicenter (17 centers in China), open-label, phase II', 'patients with stage IIIA-N2 non-small-cell lung cancer with  EGFR  mutations in exon 19 or 21', '386 patients screened, 72 were randomly assigned to treatment (intention-to-treat population), and 71 were included in the safety analysis (one patient withdrew before treatment']","['erlotinib versus gemcitabine plus cisplatin (GC chemotherapy', 'epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors', 'Erlotinib Versus Gemcitabine Plus Cisplatin', 'erlotinib 150 mg/d (neoadjuvant therapy', 'GC chemotherapy', 'gemcitabine 1,250 mg/m 2  plus cisplatin 75 mg/m 2  (neoadjuvant therapy']","['major pathologic response', 'objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors', 'pathologic complete response', 'ORR', 'pathologic complete response, progression-free survival (PFS), overall survival, safety, and tolerability', 'Median PFS']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}]","[{'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2978152', 'cui_str': 'erlotinib 150 MG [Tarceva]'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",72.0,0.11076,"Median PFS was significantly longer with erlotinib (21.5 months) versus GC chemotherapy (11.4 months; hazard ratio, 0.39; 95% CI, 0.23 to 0.67;  P  < .001).","[{'ForeName': 'Wen-Zhao', 'Initials': 'WZ', 'LastName': 'Zhong', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ke-Neng', 'Initials': 'KN', 'LastName': 'Chen', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Fujian Medical University Union Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Chun-Dong', 'Initials': 'CD', 'LastName': 'Gu', 'Affiliation': ""First Affiliated Hospital of Dalian Medical University, Dalian, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Peking University People's Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xue-Ning', 'Initials': 'XN', 'LastName': 'Yang', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wei-Min', 'Initials': 'WM', 'LastName': 'Mao', 'Affiliation': ""Zhejiang Cancer Hospital, Hangzhou, People's Republic of China.""}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Zhongshan Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Gui-Bin', 'Initials': 'GB', 'LastName': 'Qiao', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Jilin Provincial Tumor Hospital, Changchun, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Jiangsu Cancer Institute and Hospital, Nanjing, People's Republic of China.""}, {'ForeName': 'Chang-Li', 'Initials': 'CL', 'LastName': 'Wang', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China.""}, {'ForeName': 'Ming-Wei', 'Initials': 'MW', 'LastName': 'Chen', 'Affiliation': ""First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Xiaozheng', 'Initials': 'X', 'LastName': 'Kang', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Wanpu', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Hong-Hong', 'Initials': 'HH', 'LastName': 'Yan', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ri-Qiang', 'Initials': 'RQ', 'LastName': 'Liao', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jin-Ji', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xu-Chao', 'Initials': 'XC', 'LastName': 'Zhang', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00075']
3032,30674700,Adherence therapy for schizophrenia: a randomised controlled trial.,,2019,,['schizophrenia'],['Adherence therapy'],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.26051,,"[{'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'Nethersole School of Nursing, The Chinese University of Hong Kong.'}, {'ForeName': 'E F C', 'Initials': 'EFC', 'LastName': 'Cheung', 'Affiliation': 'Castle Peak Hospital, Hospital Authority, Hong Kong.'}, {'ForeName': 'J H C', 'Initials': 'JHC', 'LastName': 'Mui', 'Affiliation': 'Castle Peak Hospital, Hospital Authority, Hong Kong.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gray', 'Affiliation': 'Faculty of Medicine & Health Sciences, University of East Anglia, United Kingdom.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ip', 'Affiliation': 'Kwai Chung Hospital, Hospital Authority, Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[]
3033,30092948,Asymmetric and Symmetric Dimethylarginine Predict Outcomes in Patients With Atrial Fibrillation: An ARISTOTLE Substudy.,"BACKGROUND


There is little mechanistic information on factors predisposing atrial fibrillation (AF) patients to thromboembolism or bleeding, but generation of nitric oxide (NO) might theoretically contribute to both.
OBJECTIVES


The authors tested the hypothesis that plasma levels of the methylated arginine derivatives asymmetric and symmetric dimethylarginine (ADMA/SDMA), which inhibit NO generation, might be associated with outcomes in AF.
METHODS


Plasma samples were obtained from 5,004 patients with AF at randomization to warfarin or apixaban in the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial. ADMA and SDMA concentrations were measured by high-performance liquid chromatography. Relationships to clinical characteristics were evaluated by multivariable analyses. Associations with major outcomes, during a median of 1.9 years follow-up, were evaluated by adjusted Cox proportional hazards models.
RESULTS


Both ADMA and SDMA plasma concentrations at study entry increased significantly with patients' age, female sex, renal impairment, permanent AF, or congestive heart failure. ADMA and SDMA increased (p < 0.001) with both increased CHA 2 DS 2 -VASc and HAS-BLED scores, but decreased in the presence of diabetes. On multivariable analysis adjusting for established risk factors and treatment, tertile groups of ADMA concentrations were significantly associated with stroke/systemic embolism (p = 0.034), and death (p < 0.0001), whereas tertile groups of SDMA were associated with major bleeding and death (p < 0.001 for both). Incorporating ADMA and SDMA into CHA 2 DS 2 -VASc or HAS-BLED predictive models improved C-indices for those outcomes. Neither ADMA nor SDMA predicted differential responses to warfarin or apixaban.
CONCLUSIONS


In anticoagulated patients with AF, elevated ADMA levels are weakly associated with thromboembolic events, elevated SDMA levels with bleeding events and both are strongly associated with increased mortality. These findings suggest that disturbances of NO function modulate both thrombotic and hemorrhagic risk in anticoagulated patients with AF. (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation [ARISTOTLE]; NCT00412984).",2018,"Both ADMA and SDMA plasma concentrations at study entry increased significantly with patients' age, female sex, renal impairment, permanent AF, or congestive heart failure.","['anticoagulated patients with AF', 'Patients With Atrial Fibrillation', '5,004 patients with AF at randomization to', 'Atrial Fibrillation']",['warfarin or apixaban'],"['death', 'ADMA and SDMA concentrations', 'CHA 2 DS 2 -VASc and HAS-BLED scores', 'SDMA plasma concentrations', 'elevated ADMA levels', 'stroke/systemic embolism', 'ADMA and SDMA', 'mortality', 'thromboembolic events, elevated SDMA levels with bleeding events', 'major bleeding and death', 'ADMA concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3875442', 'cui_str': 'HAS-BLED score'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",5004.0,0.0315276,"Both ADMA and SDMA plasma concentrations at study entry increased significantly with patients' age, female sex, renal impairment, permanent AF, or congestive heart failure.","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Horowitz', 'Affiliation': 'Cardiology Unit, Basil Hetzel Institute, Queen Elizabeth Hospital, University of Adelaide, Adelaide, South Australia, Australia. Electronic address: john.horowitz@adelaide.edu.au.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caterina', 'Affiliation': ""G. d'Annunzio University, Chieti, Italy; G. Monasterio Foundation, Pisa, Italy.""}, {'ForeName': 'Tamila', 'Initials': 'T', 'LastName': 'Heresztyn', 'Affiliation': 'Cardiology Unit, Basil Hetzel Institute, Queen Elizabeth Hospital, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Andersson', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala, Sweden.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'INSERM-Unité 698, Paris, France; Assistance Publique-Hôpitaux de Paris, Paris, France; Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Paris, France; Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France; NHLI Imperial College, ICMS, Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Hylek', 'Affiliation': 'Boston University Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Mohan', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jansky', 'Affiliation': 'Cardiovascular Centre, University Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala, Sweden; Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2018.05.058']
3034,30674705,Combined electroacupuncture and auricular acupuncture for primary insomnia: a randomised controlled trial of dose-response effect.,,2019,,['primary insomnia'],['electroacupuncture and auricular acupuncture'],[],"[{'cui': 'C0033139', 'cui_str': 'Primary Insomnia'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0752217', 'cui_str': 'Auricular Acupuncture'}]",[],,0.362996,,"[{'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, The University of Hong Kong.'}, {'ForeName': 'W F', 'Initials': 'WF', 'LastName': 'Yeung', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong.'}, {'ForeName': 'B Y M', 'Initials': 'BYM', 'LastName': 'Yu', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University.'}, {'ForeName': 'Z J', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[]
3035,31283407,Outcome of Infants Younger Than 1 Year With Acute Lymphoblastic Leukemia Treated With the Interfant-06 Protocol: Results From an International Phase III Randomized Study.,"PURPOSE


Infant acute lymphoblastic leukemia (ALL) is characterized by  KMT2A  ( MLL ) gene rearrangements and coexpression of myeloid markers. The Interfant-06 study, comprising 18 national and international study groups, tested whether myeloid-style consolidation chemotherapy is superior to lymphoid style, the role of stem-cell transplantation (SCT), and which factors had independent prognostic value.
MATERIALS AND METHODS


Three risk groups were defined: low risk (LR):  KMT2A  germline; high risk (HR):  KMT2A -rearranged and older than 6 months with WBC count 300 × 10 9 /L or more or a poor prednisone response; and medium risk (MR): all other  KMT2A -rearranged cases. Patients in the MR and HR groups were randomly assigned to receive the lymphoid course low-dose cytosine arabinoside [araC], 6-mercaptopurine, cyclophosphamide (IB) or experimental myeloid courses, namely araC, daunorubicin, etoposide (ADE) and mitoxantrone, araC, etoposide (MAE).
RESULTS


A total of 651 infants were included, with 6-year event-free survival (EFS) and overall survival of 46.1% (SE, 2.1) and 58.2% (SE, 2.0). In West European/North American groups, 6-year EFS and overall survival were 49.4% (SE, 2.5) and 62.1% (SE, 2.4), which were 10% to 12% higher than in other countries. The 6-year probability of disease-free survival was comparable for the randomized arms (ADE+MAE 39.3% [SE 4.0; n = 169]  v  IB 36.8% [SE, 3.9; n = 161]; log-rank  P  = .47). The 6-year EFS rate of patients in the HR group was 20.9% (SE, 3.4) with the intention to undergo SCT; only 46% of them received SCT, because many had early events.  KMT2A  rearrangement was the strongest prognostic factor for EFS, followed by age, WBC count, and prednisone response.
CONCLUSION


Early intensification with postinduction myeloid-type chemotherapy courses did not significantly improve outcome for infant ALL compared with the lymphoid-type course IB. Outcome for infant ALL in Interfant-06 did not improve compared with that in Interfant-99.",2019,"The 6-year probability of disease-free survival was comparable for the randomized arms (ADE+MAE 39.3% [SE 4.0; n = 169]  v  IB 36.8% [SE, 3.9; n = 161]; log-rank  P  =","['651 infants', 'Younger Than 1 Year', 'Infant acute lymphoblastic leukemia (ALL', 'Infants', 'Patients in the MR and HR groups', 'KMT2A  germline; high risk (HR):  KMT2A -rearranged and older than 6 months with WBC count 300 × 10 9 /L or more or a poor prednisone response; and medium risk (MR']","['lymphoid course low-dose cytosine arabinoside [araC], 6-mercaptopurine, cyclophosphamide (IB) or experimental myeloid courses, namely araC, daunorubicin, etoposide (ADE) and mitoxantrone, araC, etoposide (MAE', 'Interfant-06 Protocol', 'myeloid-style consolidation chemotherapy']","['6-year event-free survival (EFS) and overall survival', '6-year probability of disease-free survival', '6-year EFS and overall survival', '6-year EFS rate']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439677', 'cui_str': 'Myeloid (qualifier value)'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",651.0,0.0796176,"The 6-year probability of disease-free survival was comparable for the randomized arms (ADE+MAE 39.3% [SE 4.0; n = 169]  v  IB 36.8% [SE, 3.9; n = 161]; log-rank  P  =","[{'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Pieters', 'Affiliation': 'Dutch Childhood Oncology Group, Utrecht, the Netherlands.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'De Lorenzo', 'Affiliation': 'University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ancliffe', 'Affiliation': 'United Kingdom Children Cancer Study Group, London, United Kingdom.'}, {'ForeName': 'Luis Alberto', 'Initials': 'LA', 'LastName': 'Aversa', 'Affiliation': 'GATLA, Buenos Aires, Argentina.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Brethon', 'Affiliation': 'French Acute Lymphoblastic Leukemia Study Group, Paris, France.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Biondi', 'Affiliation': 'University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Chilean National Pediatric Oncology Group, Santiago, Chile.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Escherich', 'Affiliation': 'German Cooperative Study Group for Childhood Acute Lymphoblastic Leukemia, Hamburg, Germany.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Ferster', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Children Leukemia Group, Brussels, Belgium.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Gardner', 'Affiliation': ""Seattle Children's Hospital and Research Institute, Seattle, WA.""}, {'ForeName': 'Rishi Sury', 'Initials': 'RS', 'LastName': 'Kotecha', 'Affiliation': ""Australian and New Zealand Children's Haematology/Oncology Group, Perth, Australia.""}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Lausen', 'Affiliation': 'Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Chi Kong', 'Initials': 'CK', 'LastName': 'Li', 'Affiliation': ""The Chinese University of Hong Kong, Shatin, Hong Kong, Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': 'University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Andishe', 'Initials': 'A', 'LastName': 'Attarbaschi', 'Affiliation': ""St Anna Children's Hospital, Medical University of Vienna, Vienna, Austria.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': 'Children Cancer Research Institute, Vienna, Austria.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Lewis B', 'Initials': 'LB', 'LastName': 'Silverman', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stary', 'Affiliation': 'Czech Working Group for Pediatric Hematology, Prague, Czech Republic.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Szczepanski', 'Affiliation': 'Polish Pediatric Leukemia/Lymphoma Study Group, Zabrze, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Vora', 'Affiliation': 'United Kingdom Children Cancer Study Group, London, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schrappe', 'Affiliation': 'Berlin-Frankfurt-Münster Group Germany, Kiel, Germany.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Valsecchi', 'Affiliation': 'University of Milano-Bicocca, Monza, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00261']
3036,32440935,"Correction to: A prospective randomized trial comparing corifollitropin-α late-start (day 4) versus standard administration (day 2) in expected poor, normal, and high responders undergoing controlled ovarian stimulation for IVF.",The original article unfortunately has a missing acknowledgement.,2020,The original article unfortunately has a missing acknowledgement.,[],['corifollitropin-α late-start (day 4) versus standard administration'],[],[],"[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.0221903,The original article unfortunately has a missing acknowledgement.,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Revelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy. alberto.revelli@unito.it.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gennarelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Sestero', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Canosa', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carosso', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Salvagno', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Pittatore', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Filippini', 'Affiliation': 'Clinical Statistics, Department of Surgical Sciences, University of Torino, Corso Bramante 88, Turin, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Benedetto', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-020-01823-5']
3037,32440753,The impact of reimbursement negotiations on cost and availability of new pharmaceuticals: evidence from an online experiment.,"BACKGROUND


The necessity to measure and reward ""value for money"" of new pharmaceuticals has become central in health policy debates, as much as the requirement to assess the ""willingness to pay"" for an additional, quality-adjusted life year (QALY). There is a clear need to understand the capacity of ""value-based"" pricing policies to impact societal goals, like timely access to new treatments, sustainable health budgets, or incentivizing research to improve patient outcomes. Not only the pricing mechanics, but also the process of value assessment and price negotiation are subject to reform demands. This study assesses the impact of a negotiation situation for life-extending pharmaceuticals on societal outcomes. Of interest were general effects of the bargaining behaviour, as well as differences caused by the assigned role and the magnitude of prices.
METHODS


We ran an online experiment (n = 404) on Amazon Mechanical Turk (MTurk). Participants were randomly assigned into four treatment groups for a reimbursement negotiation between two roles (health minister, pharma representative) in two price framings. Payoff to players consisted of a fixed salary and a potential bonus, depending on their preferences, their price offer and the counter offer of a randomly paired negotiation partner. Success had real social consequences on other MTurk users (premium payers, investors) and via donations to a patient association.
RESULTS


Margins between reservation prices and price offers increased throughout the game. Yet, 47% of players reduced at least once and 15% always their bonus probability to zero in favour of an agreement. 61% of simulated negotiation pairs could have reached an agreement, based on their preferences. 63% of these were successful, leaving 61% of patients with no access to the new treatment. The group with ""real world"" prices had lower prices and less agreements than the unconverted payoff group. The successful markets redistributed 20% of total assets from premium payers to investors over five innovation cycles.
CONCLUSIONS


The negotiation situation for pharmaceutical reimbursement has notable impact on societal outcomes. Further research should evaluate policies that align preferences and increase negotiation success.",2020,"The group with ""real world"" prices had lower prices and less agreements than the unconverted payoff group.",[],['Amazon Mechanical Turk (MTurk'],['real social consequences'],[],"[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0686907', 'cui_str': 'Consequence of'}]",,0.0286289,"The group with ""real world"" prices had lower prices and less agreements than the unconverted payoff group.","[{'ForeName': 'Dominik J', 'Initials': 'DJ', 'LastName': 'Wettstein', 'Affiliation': 'Department of Health Sciences and Medicine, University of Lucerne, Frohburgstrasse 3, P.O. Box 4466, CH-6002, Lucerne, Switzerland. dominik.wettstein@stud.unilu.ch.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Boes', 'Affiliation': 'Department of Health Sciences and Medicine, University of Lucerne, Frohburgstrasse 3, P.O. Box 4466, CH-6002, Lucerne, Switzerland.'}]",Health economics review,['10.1186/s13561-020-00267-y']
3038,32440816,"Omega-3 fatty acids reduce post-operative risk of deep vein thrombosis and pulmonary embolism after surgery for elderly patients with proximal femoral fractures: a randomized placebo-controlled, double-blind clinical trial.","BACKGROUND


Elderly patients with proximal femoral fractures face elevated risk of post-operative deep vein thrombosis and pulmonary embolism, due to the lack of suitable treatment plans after surgery and hospital discharge. This study aimed to investigate the effect of omega-3 fatty acid supplementation in the above-described clinical setting.
METHODS


Five hundred and seven elderly patients (> 60 years of age) suffering from proximal femoral fractures were recruited. After exclusion, 452 eligible patients were assigned in a random manner to receive either omega-3 fatty acids at the daily dose of 1000 mg or placebo, via oral administration for a period of 30 days after surgery. At the end of intervention, the incidences of pulmonary embolism, deep vein thrombosis, and other related complications were compared between the two study groups.
RESULTS


Incidences of pulmonary embolism as well as deep vein thrombosis, including events leading to fatality, were significantly reduced by the 30-day omega-3 fatty acid intervention. But other related complications, such as haematoma evacuation, post-operative wound bleed, wound infection with frank pus, and other bleed events that required transfusion, were not affected after omega-3 fatty acid consumption.
CONCLUSION


Daily supplementation of omega-3 fatty acids decreases the risk of pulmonary embolism as well as symptomatic deep vein thrombosis, after surgery among elderly patients with proximal femoral fractures, without causing elevated risk of bleeding episodes.",2020,"RESULTS


Incidences of pulmonary embolism as well as deep vein thrombosis, including events leading to fatality, were significantly reduced by the 30-day omega-3 fatty acid intervention.","['elderly patients with proximal femoral fractures', '452 eligible patients', 'Elderly patients with proximal femoral fractures', 'Five hundred and seven elderly patients (> 60 years of age) suffering from proximal femoral fractures were recruited']","['omega-3 fatty acids', 'Omega-3 fatty acids', 'omega-3 fatty acids at the daily dose of 1000 mg or placebo', 'omega-3 fatty acid supplementation', 'placebo']","['risk of pulmonary embolism', 'incidences of pulmonary embolism, deep vein thrombosis, and other related complications', 'deep vein thrombosis']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",507.0,0.273138,"RESULTS


Incidences of pulmonary embolism as well as deep vein thrombosis, including events leading to fatality, were significantly reduced by the 30-day omega-3 fatty acid intervention.","[{'ForeName': 'Xinying', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Nursing, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Rufu', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': 'Department of Nursing, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China. Hlbzxy2@163.com.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesia of West Hospital, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesia of West Hospital, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}, {'ForeName': 'Zhijing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesia of West Hospital, Cangzhou Central Hospital, Xinhua West Road, Cangzhou, 061000, Hebei, China.'}]",International orthopaedics,['10.1007/s00264-020-04610-0']
3039,32440738,Evaluation of a collaborative care program for pulmonary hypertension patients: a multicenter randomized trial.,"Background Pulmonary hypertension is a rare, chronic and life-threatening group of diseases. Recent advances in pulmonary hypertension management prolong survival and improve quality-of-life. However, highly complex drug therapy enhances the risk of drug-related problems. Objective To assess the impact of involving clinical pharmacists in the collaborative care of pulmonary hypertension patients. Setting Ten French University Hospital Pneumology departments, all members of the French Network for Pulmonary Hypertension. Methods This prospective multicenter randomized controlled trial included incident pulmonary hypertension patients who were followed-up for 18 months. Randomization using an adapted Zelen method allocated patients to collaborative care (n = 41) or usual care groups (n = 51). A collaborative care program involving clinical pharmacists was developed through a close partnership between with physicians, nurses and pharmacists. Besides usual care, the program includes regular one-to-one interviews between the pharmacist and the patient. These interviews had following objectives: to perform an exhaustive medication history review; to identify the patient' needs, knowledge and skills; to define educational objectives and to provide patients with relevant information when needed. Following each interview, a standardized report form containing the pharmacist's recommendations was provided to physicians and nurses and discussed collaboratively. An ancillary economic analysis was performed. Main outcome measure Number of drug-related problems and their outcomes. Results The number of drug-related problems was not significantly different between groups (1.6 ± 1.5 vs. 1.9 ± 2.4; p = 0.41). More problems were resolved in the collaborative care group than in the usual care group (86.5% vs. 66.7%, p = 0.01). Time to clinical worsening, therapeutic adherence, satisfaction or quality-of-life were not statistically different between groups. Collaborative care decreased costs of drug-related hospitalizations. Conclusion Including clinical pharmacists in the multidisciplinary care of hospitalized patients with pulmonary hypertension improved the outcome of drug-related problems and reduced the costs of related hospitalization. However, we observed no efficacy on medication errors, clinical outcomes or medication adherence. Clinical Trial Registration ClinicalTrials.gov Identifier NCT01038284.",2020,"More problems were resolved in the collaborative care group than in the usual care group (86.5% vs. 66.7%, p = 0.01).","['incident pulmonary hypertension patients who were followed-up for 18\xa0months', 'pulmonary hypertension patients', 'Setting Ten French University Hospital Pneumology departments, all members of the French Network for Pulmonary Hypertension', 'hospitalized patients with pulmonary hypertension']","['adapted Zelen method allocated patients to collaborative care (n\u2009=\u200941) or usual care groups', 'collaborative care program']","['number of drug-related problems', 'medication errors, clinical outcomes or medication adherence', 'quality-of-life', 'Time to clinical worsening, therapeutic adherence, satisfaction or quality-of-life', 'Number of drug-related problems and their outcomes', 'costs of drug-related hospitalizations', 'costs of related hospitalization']","[{'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0034060', 'cui_str': 'Pulmonary medicine'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.128263,"More problems were resolved in the collaborative care group than in the usual care group (86.5% vs. 66.7%, p = 0.01).","[{'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Roustit', 'Affiliation': 'Faculty of Medicine and Pharmacy, Grenoble Alpes University, 38000, Grenoble, France. MRoustit@chu-grenoble.fr.'}, {'ForeName': 'Marie-Camille', 'Initials': 'MC', 'LastName': 'Chaumais', 'Affiliation': 'Faculty of Pharmacy, Paris-Sud University, 92290, Châtenay Malabry, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Chapuis', 'Affiliation': 'Faculty of Medicine and Pharmacy, Grenoble Alpes University, 38000, Grenoble, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gairard-Dory', 'Affiliation': 'Pharmacy Department, Strasbourg University Hospital, 67000, Strasbourg, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hadjadj', 'Affiliation': 'Health Products Division, Bordeaux University Hospital, 33600, Pessac, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Chanoine', 'Affiliation': 'Faculty of Medicine and Pharmacy, Grenoble Alpes University, 38000, Grenoble, France.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Allenet', 'Affiliation': 'Faculty of Medicine and Pharmacy, Grenoble Alpes University, 38000, Grenoble, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sitbon', 'Affiliation': 'INSERM UMR_S 999, Marie Lannelongue Surgery Center, 92350, Le Plessis Robinson, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pison', 'Affiliation': 'Faculty of Medicine and Pharmacy, Grenoble Alpes University, 38000, Grenoble, France.'}, {'ForeName': 'Pierrick', 'Initials': 'P', 'LastName': 'Bedouch', 'Affiliation': 'Faculty of Medicine and Pharmacy, Grenoble Alpes University, 38000, Grenoble, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of clinical pharmacy,['10.1007/s11096-020-01047-8']
3040,31461123,Association of Multifaceted Mobile Technology-Enabled Primary Care Intervention With Cardiovascular Disease Risk Management in Rural Indonesia.,"Importance


Cardiovascular diseases (CVDs) are the leading cause of disease burden in Indonesia. Implementation of effective interventions for CVD prevention is limited.
Objective


To evaluate whether a mobile technology-supported primary health care intervention, compared with usual care, would improve the use of preventive drug treatment among people in rural Indonesia with a high risk of CVD.
Design, Setting, and Participants


A quasi-experimental study involving 6579 high-risk individuals in 4 intervention and 4 control villages in Malang district, Indonesia, was conducted between August 16, 2016, and March 31, 2018. Median duration of follow-up was 12.2 months. Residents 40 years or older were invited to participate. Those with high estimated 10-year risk of CVD risk (previously diagnosed CVD, systolic blood pressure [BP] >160 mm Hg or diastolic BP >100 mm Hg, 10-year estimated CVD risk of 30% or more, or 10-year estimated CVD risk of 20%-29% and a systolic BP >140 mm Hg) were followed up.
Interventions


A multifaceted mobile technology-supported intervention facilitating community-based CVD risk screening with referral, tailored clinical decision support for drug prescription, and patient follow-up.
Main Outcomes and Measures


The primary outcome was the proportion of individuals taking appropriate preventive CVD medications, defined as at least 1 BP-lowering drug and a statin for all high-risk individuals, and an antiplatelet drug for those with prior diagnosed CVD. Secondary outcomes included mean change in BP from baseline.
Results


Among 22 635 adults, 3494 of 11 647 in the intervention villages (30.0%; 2166 women and 1328 men; mean [SD] age, 58.3 [10.9] years) and 3085 of 10 988 in the control villages (28.1%; 1838 women and 1247 men; mean [SD] age, 59.0 [11.5] years) had high estimated risk of CVD. Of these, follow-up was completed in 2632 individuals (75.3%) from intervention villages and 2429 individuals (78.7%) from control villages. At follow-up, 409 high-risk individuals in intervention villages (15.5%) were taking appropriate preventive CVD medications, compared with 25 (1.0%) in control villages (adjusted risk difference, 14.1%; 95% CI, 12.7%-15.6%). This difference was driven by higher use of BP-lowering medication in those in the intervention villages (1495 [56.8%] vs 382 [15.7%]; adjusted risk difference, 39.4%; 95% CI, 37.0%-41.7%). The adjusted mean difference in change in systolic BP from baseline was -8.3 mm Hg (95% CI, -10.1 to -6.6 mm Hg).
Conclusions and Relevance


This study found that a multifaceted mobile technology-supported primary health care intervention was associated with greater use of preventive CVD medication and lower BP levels among high-risk individuals in a rural Indonesian population.",2019,This study found that a multifaceted mobile technology-supported primary health care intervention was associated with greater use of preventive CVD medication and lower BP levels among high-risk individuals in a rural Indonesian population.,"['6579 high-risk individuals in 4 intervention and 4 control villages in Malang district, Indonesia, was conducted between August 16, 2016, and March 31, 2018', 'high-risk individuals in a rural Indonesian population', '2632 individuals (75.3%) from intervention villages and 2429 individuals (78.7%) from control villages', 'people in rural Indonesia with a high risk of CVD', 'Rural Indonesia', 'Among 22\u202f635 adults, 3494 of 11 647 in the intervention villages (30.0%; 2166 women and 1328 men; mean [SD] age, 58.3 [10.9] years) and 3085 of 10\u202f988 in the control villages (28.1%; 1838 women and 1247 men; mean [SD] age, 59.0 [11.5] years) had high estimated risk of CVD', 'Residents 40 years or older were invited to participate']","['Multifaceted Mobile Technology-Enabled Primary Care Intervention', 'multifaceted mobile technology-supported intervention facilitating community-based CVD risk screening with referral, tailored clinical decision support for drug prescription, and patient follow-up', 'mobile technology-supported primary health care intervention', 'multifaceted mobile technology-supported primary health care intervention']","['BP-lowering medication', 'Median duration', 'mean change in BP from baseline', 'BP levels', 'systolic BP', 'proportion of individuals taking appropriate preventive CVD medications, defined as at least 1 BP-lowering drug and a statin', 'systolic blood pressure [BP']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0337900', 'cui_str': 'Indonesians (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C4042765', 'cui_str': 'Clinical Decision Support'}, {'cui': 'C0033081', 'cui_str': 'Drug Prescriptions'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",409.0,0.211716,This study found that a multifaceted mobile technology-supported primary health care intervention was associated with greater use of preventive CVD medication and lower BP levels among high-risk individuals in a rural Indonesian population.,"[{'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Devarsetty', 'Initials': 'D', 'LastName': 'Praveen', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Hyderabad, India.'}, {'ForeName': 'Asri', 'Initials': 'A', 'LastName': 'Maharani', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Delvac', 'Initials': 'D', 'LastName': 'Oceandy', 'Affiliation': 'Division of Cardiovascular Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Pilard', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Mohan P S', 'Initials': 'MPS', 'LastName': 'Kohli', 'Affiliation': 'Independent Public Health Consultant, New Delhi, India.'}, {'ForeName': 'Sujarwoto', 'Initials': 'S', 'LastName': 'Sujarwoto', 'Affiliation': 'Department of Public Administration, University of Brawijaya, Malang, Indonesia.'}, {'ForeName': 'Gindo', 'Initials': 'G', 'LastName': 'Tampubolon', 'Affiliation': 'Global Development Institute, The University of Manchester, Manchester, United Kingdom.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2974']
3041,31574303,Echocardiographic Outcomes After Transcatheter Leaflet Approximation in Patients With Secondary Mitral Regurgitation: The COAPT Trial.,"BACKGROUND


In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial among patients with heart failure (HF) and moderate-to-severe (3+) or severe (4+) secondary mitral regurgitation, patients treated with transcatheter mitral valve repair (TMVr) through leaflet approximation had reduced rates of HF hospitalization and mortality compared with guideline-directed medical therapy (GDMT) alone.
OBJECTIVES


The purpose of this study was to describe the echocardiographic patient qualification process for the COAPT trial, baseline echocardiographic characteristics, changes over time, and the interaction between treatment group and echocardiographic parameters on clinical outcomes.
METHODS


A novel echocardiographic algorithm was implemented for grading mitral regurgitation severity during the screening process. Standardized echocardiograms were obtained at baseline and during regular follow-up intervals through 2 years, and were analyzed by a core laboratory.
RESULTS


A total of 614 patients were randomized to TMVr plus maximally tolerated GDMT or GDMT alone. Mean baseline left ventricular (LV) ejection fraction was 31.3 ± 9.3%, LV end-diastolic volume was 192.7 ± 71 ml, and effective regurgitant orifice area was 0.41 ± 0.15 cm 2 . The beneficial effect of TMVr compared with GDMT alone was consistent in all echocardiographic subgroups, independent of the severity of LV dysfunction, LV dilatation, pulmonary hypertension, severity of tricuspid regurgitation, or individual mitral regurgitation characteristics. The LV ejection fraction decreased and the LV volumes progressively increased in both groups during follow-up, although less after TMVr (p < 0.05).
CONCLUSIONS


HF patients in the COAPT trial with 3+ or 4+ secondary mitral regurgitation, selected using strict echocardiographic criteria, benefitted from TMVr with reduced 2-year rates of death and HF hospitalization. Strict application of these echocardiographic criteria should enable the COAPT results to be translated to clinical practice. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079).",2019,"The LVEF decreased and the LV volumes progressively increased in both groups during follow-up, although less after TMVR (P<0.05).
","['614 patients', 'patients with heart failure (HF) and moderate-to-severe (3+) or severe (4+) secondary mitral regurgitation (SMR), patients treated with the', 'Patients with Heart Failure and Secondary Mitral Regurgitation']","['TMVR plus maximally- tolerated GDMT or GDMT alone', 'Transcatheter Mitral Valve Replacement', 'transcatheter mitral valve replacement (TMVR', 'GDMT', 'guideline-directed medical therapy (GDMT) alone', 'TMVR']","['severity of LV dysfunction, LV dilatation, pulmonary hypertension, severity of tricuspid regurgitation or individual MR characteristics', '2-year rates of death and HF hospitalization', 'rates of HF hospitalization and mortality', 'LVEF', 'Mean baseline left ventricular ejection fraction (LVEF', 'LV end-diastolic volume', 'LV volumes', 'effective regurgitant orifice area']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0026266', 'cui_str': 'Mitral Incompetence'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach (qualifier value)'}, {'cui': 'C0026268', 'cui_str': 'Replacement of mitral valve (procedure)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid Regurgitation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",614.0,0.0692407,"The LVEF decreased and the LV volumes progressively increased in both groups during follow-up, although less after TMVR (P<0.05).
","[{'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Asch', 'Affiliation': 'Cardiovascular Core Laboratories, MedStar Health Research Institute, Washington, DC. Electronic address: federico.asch@medstar.net.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Grayburn', 'Affiliation': 'Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, Texas.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Siegel', 'Affiliation': 'Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Saibal', 'Initials': 'S', 'LastName': 'Kar', 'Affiliation': 'Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Lim', 'Affiliation': 'Division of Cardiology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Zaroff', 'Affiliation': 'Kaiser Permanente-San Francisco Hospital, San Francisco, California.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Mishell', 'Affiliation': 'Kaiser Permanente-San Francisco Hospital, San Francisco, California.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Whisenant', 'Affiliation': 'Intermountain Medical Center, Murray, Utah.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mack', 'Affiliation': 'Baylor Scott & White Heart and Vascular Hospital, Plano, Texas.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Advanced Heart Failure, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Departments of Medicine, Physiology, and Cell Biology, Division of Cardiovascular Medicine, and the Davis Heart and Lung Research Institute, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; The Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Weissman', 'Affiliation': 'Cardiovascular Core Laboratories, MedStar Health Research Institute, Washington, DC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.017']
3042,32440838,"No mesh versus mesh in the treatment of anterior vaginal wall prolapse: prospective, randomised, controlled trial, long-term follow-up.","OBJECTIVES


To compare the efficacy and safety of anterior colporrhaphy (AC) versus transvaginal polypropylene mesh (PM) for the treatment of anterior vaginal wall prolapse (AVWP) at long-term follow-up.
METHODS


Prospective and randomized controlled trial, 100 women with AVWP stage ≥ II assessed by the Pelvic Organ Prolapse Quantification System (POP-Q) underwent AC (control group) or PM insertion (mesh group). At baseline and at 60-month follow-up, safety profile, anatomical outcomes by POP-Q measurements and staging, subjective outcomes and quality of life (QoL) impact by ICIQ (SF and VV) and OAB-V8 questionnaires were assessed RESULTS: 76 women completed the study, 43 in Control versus 33 in Mesh group. Significant improvements were observed in all variables between the 2 times in each group (p < 0.0001), without differences between groups. Objective cure (POP-Q Ba ≤ - 2 and Ba ≤ - 1) occurred in 22 and 36 (51.2 and 83.7%) versus 23 and 31 (69.7 and 93.9%), p = 0.10 and 0.29; and subjective cure (VSS, no vaginal symptom) in 21 (48.8%) versus 17 (51.5%), p = 0.82, respectively, at 60-month follow-up. When adjusted for the other variables, Mesh group showed worse QoL impact due to subjective vaginal symptoms (odds ratio 3.99, CI 95% 1.13; 14.13). AVW asymptomatic mesh exposure occurred in 2 patients (6.06%) in the Mesh group.
CONCLUSIONS


AC and PM provided good overall objective and subjective outcomes for a minimum 60-month follow-up. Vaginal and urinary symptoms improved post-operatively in both groups. Mesh group experienced four times more negative impact on QoL compared to Control at 60-month follow-up.",2020,"Significant improvements were observed in all variables between the 2 times in each group (p < 0.0001), without differences between groups.","['76 women completed the study, 43 in Control versus 33 in Mesh group', '100 women with AVWP stage\u2009≥\u2009II assessed by the', 'anterior vaginal wall prolapse']","['anterior colporrhaphy (AC', 'transvaginal polypropylene mesh (PM', 'Pelvic Organ Prolapse Quantification System (POP-Q) underwent AC (control group) or PM insertion (mesh group']","['AVW asymptomatic mesh exposure', 'QoL', 'Objective cure (POP-Q Ba\u2009≤\u2009-\xa02 and Ba\u2009≤\u2009-\xa01', 'subjective cure (VSS, no vaginal symptom', 'Vaginal and urinary symptoms', 'safety profile, anatomical outcomes by POP-Q measurements and staging, subjective outcomes and quality of life (QoL) impact by ICIQ (SF and VV) and OAB-V8 questionnaires', 'efficacy and safety', 'subjective vaginal symptoms', 'anterior vaginal wall prolapse (AVWP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0425852', 'cui_str': 'Anterior vaginal wall prolapse'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0195224', 'cui_str': 'Anterior colporrhaphy'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C1321585', 'cui_str': 'Polypropylene mesh'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0425852', 'cui_str': 'Anterior vaginal wall prolapse'}]",100.0,0.0890086,"Significant improvements were observed in all variables between the 2 times in each group (p < 0.0001), without differences between groups.","[{'ForeName': 'José Tadeu Nunes', 'Initials': 'JTN', 'LastName': 'Tamanini', 'Affiliation': 'Department of Medicine, Federal University of Sao Carlos, São Carlos, SP, Brazil.'}, {'ForeName': 'Leonardo Oliveira', 'Initials': 'LO', 'LastName': 'Reis', 'Affiliation': 'Uroscience, Department of Urology, State University of Campinas, Unicamp and Pontifical Catholic University of Campinas, PUC-Campinas, Av. John Boyd Dunlop, Jardim Ipaussurama, Campinas, SP, Brazil. reisleo.l@gmail.com.'}, {'ForeName': 'Mirce Milhomem', 'Initials': 'MM', 'LastName': 'da Mota Tamanini', 'Affiliation': 'Department of Obstetric and Gynecology of Santa Casa, Jaú, SP, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Aquino Castro', 'Affiliation': 'Section of Urogynecology and Pelvic Surgery, Department of Gynecology, Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Marair Gracio Ferreira', 'Initials': 'MGF', 'LastName': 'Sartori', 'Affiliation': 'Section of Urogynecology and Pelvic Surgery, Department of Gynecology, Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Manoel João Batista Castello', 'Initials': 'MJBC', 'LastName': 'Girão', 'Affiliation': 'Section of Urogynecology and Pelvic Surgery, Department of Gynecology, Federal University of São Paulo, São Paulo, SP, Brazil.'}]",International urology and nephrology,['10.1007/s11255-020-02503-0']
3043,32440938,Comparison of two vasoconstrictors on glycemic levels in diabetic patients.,"OBJECTIVES


The aim of this study was to evaluate glycemic levels in diabetic patients before, during, and after extractions using 2% lidocaine with 1:100,000 epinephrine (Lido/Epi) and 3% prilocaine with 0.03 IU/mL felypressin (Prilo/Fely).
MATERIALS AND METHODS


A double-blind, randomized clinical trial was conducted to evaluate changes in body parameters and glycemic levels in diabetic patients undergoing two anesthetic protocols during dental extractions. During surgery, we evaluated blood pressure (BP), heart rate (HR), saturation (SpO2), and capillary glycemic levels (Gly). These parameters were measured at the following surgical moments: basal, 30 min after medication, incision, tooth removal, suture, and 30 and 60 min after anesthesia.
RESULTS


Data analysis showed no differences between the groups considering age, weight, and time spent in surgery. Increased systolic BP and decreased diastolic BP were observed in the lido/epi group. No difference was observed in the prilo/fely group among the surgical moments or between the groups regarding BP. No difference was observed in HR and SpO2 between the groups at any surgical moment. However, differences were found when compared the differences in glycemic and basal levels in both groups with greater decreases in blood glucose values for the lido/epi group. In anxiety level evaluation, there was no difference between the different surgical moments.
CONCLUSION


Thus, both lido/epi and prilo/fely (maximum 3.6 mL) can be safely used in controlled diabetic patients CLINICAL RELEVANCE: The use of lidocaine associated with epinephrine did not increase glycemic levels but leads to decrease over time when associated with an anxiety reduction protocol, offering some advantage over prilocaine plus felypressin for diabetic patients.",2020,No difference was observed in the prilo/fely group among the surgical moments or between the groups regarding BP.,"['diabetic patients undergoing two anesthetic protocols during dental extractions', 'diabetic patients']","['vasoconstrictors', 'lidocaine with 1:100,000 epinephrine (Lido/Epi) and 3% prilocaine with 0.03 IU/mL felypressin (Prilo/Fely', 'prilocaine plus felypressin', 'lidocaine', 'epinephrine']","['glycemic levels', 'blood pressure (BP), heart rate (HR), saturation (SpO2), and capillary glycemic levels (Gly', 'glycemic and basal levels', 'Increased systolic BP and decreased diastolic BP', 'body parameters and glycemic levels', 'blood glucose values', 'HR and SpO2']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}, {'cui': 'C0015777', 'cui_str': 'Felypressin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0277884', 'cui_str': 'Increased systolic arterial pressure'}, {'cui': 'C0277890', 'cui_str': 'Decreased diastolic arterial pressure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0547669,No difference was observed in the prilo/fely group among the surgical moments or between the groups regarding BP.,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Meneses-Santos', 'Affiliation': 'Oral surgery and anesthesiology area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Bairro Sanatório, Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil. danyymeneses@yahoo.com.br.'}, {'ForeName': 'Klinger Souza', 'Initials': 'KS', 'LastName': 'Amorim', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, Piracibaba, São Paulo, 13414-903, Brazil.'}, {'ForeName': 'Anne Caroline Gercina Carvalho', 'Initials': 'ACGC', 'LastName': 'Dantas', 'Affiliation': 'Oral surgery and anesthesiology area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Bairro Sanatório, Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}, {'ForeName': 'Ricardo Pedro', 'Initials': 'RP', 'LastName': 'da Silva', 'Affiliation': 'Oral surgery and anesthesiology area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Bairro Sanatório, Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}, {'ForeName': 'Jaiza Samara Macena', 'Initials': 'JSM', 'LastName': 'de Araújo', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, Piracibaba, São Paulo, 13414-903, Brazil.'}, {'ForeName': 'Francisco Carlos', 'Initials': 'FC', 'LastName': 'Groppo', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, Piracibaba, São Paulo, 13414-903, Brazil.'}, {'ForeName': 'Liane Maciel Almeida', 'Initials': 'LMA', 'LastName': 'Souza', 'Affiliation': 'Oral surgery and anesthesiology area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Bairro Sanatório, Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-020-03327-z']
3044,31219150,"Association Between Single-Nucleotide Polymorphisms in HLA Alleles and Human Immunodeficiency Virus Type 1 Viral Load in Demographically Diverse, Antiretroviral Therapy-Naive Participants From the Strategic Timing of AntiRetroviral Treatment Trial.","The impact of variation in host genetics on replication of human immunodeficiency virus type 1 (HIV-1) in demographically diverse populations remains uncertain. In the current study, we performed a genome-wide screen for associations of single-nucleotide polymorphisms (SNPs) to viral load (VL) in antiretroviral therapy-naive participants (n = 2440) with varying demographics from the Strategic Timing of AntiRetroviral Treatment (START) trial. Associations were assessed using genotypic data generated by a customized SNP array, imputed HLA alleles, and multiple linear regression. Genome-wide significant associations between SNPs and VL were observed in the major histocompatibility complex class I region (MHC I), with effect sizes ranging between 0.14 and 0.39 log10 VL (copies/mL). Supporting the SNP findings, we identified several HLA alleles significantly associated with VL, extending prior observations that the (MHC I) is a major host determinant of HIV-1 control with shared genetic variants across diverse populations and underscoring the limitations of genome-wide association studies as being merely a screening tool.",2019,Genome-wide significant associations between SNPs and VL were observed in the major histocompatibility complex class,"['antiretroviral therapy-naive participants (n = 2440) with varying demographics from the Strategic Timing of AntiRetroviral Treatment (START) trial', 'major histocompatibility complex class', 'HLA Alleles and Human Immunodeficiency']",[],[],"[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0024518', 'cui_str': 'Major histocompatibility complex'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021051', 'cui_str': 'Immunodeficiency disorder'}]",[],[],2440.0,0.0452578,Genome-wide significant associations between SNPs and VL were observed in the major histocompatibility complex class,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ekenberg', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Man-Hung', 'Initials': 'MH', 'LastName': 'Tang', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Zucco', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Murray', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Cameron Ross', 'Initials': 'CR', 'LastName': 'MacPherson', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Laboratory of Human Retrovirology and Immunoinformatics, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Bethesda, Maryland.'}, {'ForeName': 'Brad T', 'Initials': 'BT', 'LastName': 'Sherman', 'Affiliation': 'Laboratory of Human Retrovirology and Immunoinformatics, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Bethesda, Maryland.'}, {'ForeName': 'Marcelo H', 'Initials': 'MH', 'LastName': 'Losso', 'Affiliation': 'Hospital General de Agudos JM Ramos, Buenos Aires, Argentina.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Wood', 'Affiliation': 'Desmond Tutu HIV Foundation Clinical Trials Unit, Cape Town, South Africa.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': 'Infectious Diseases Service and irsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Department of Infectious Diseases, University of Paris Diderot, Sorbonne Paris Cité, and Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Helleberg', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Nureen', 'Initials': 'N', 'LastName': 'Jina', 'Affiliation': 'Clinical HIV Research Unit, Wits Health Consortium, Department of Medicine, University of the Witwatersrand, Helen Joseph Hospital, Themba Lethu Clinic, Johannesburg, South Africa.'}, {'ForeName': 'Cissy M', 'Initials': 'CM', 'LastName': 'Kityo', 'Affiliation': 'Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Florence', 'Affiliation': 'Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Polizzotto', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis.'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Division of Clinical Research, Bethesda, Maryland.'}, {'ForeName': 'Jens D', 'Initials': 'JD', 'LastName': 'Lundgren', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz294']
3045,31319922,Inferior Caval Valve Implantation Versus Optimal Medical Therapy for Severe Tricuspid Regurgitation.,,2019,,['Severe Tricuspid Regurgitation'],['Inferior Caval Valve Implantation Versus Optimal Medical Therapy'],[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}]","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]",[],,0.0145216,,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Laule', 'Affiliation': ''}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mattig', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schöbel', 'Affiliation': ''}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Knebel', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lauten', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lembcke', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Thoenes', 'Affiliation': ''}, {'ForeName': 'Herko', 'Initials': 'H', 'LastName': 'Grubitzsch', 'Affiliation': ''}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Stangl', 'Affiliation': ''}, {'ForeName': 'Henryk', 'Initials': 'H', 'LastName': 'Dreger', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.05.019']
3046,32162607,Assessment of bioavailability of Mg from Mg citrate and Mg oxide by measuring urinary excretion in Mg-saturated subjects.,"BACKGROUND


Low magnesium (Mg) levels are linked to many diseases. Studies suggest that organic salts of Mg are more readily bioavailable than its oxide or inorganic salts used for supplements production. Unfortunately, the plethora of variables in the previous study designs complicates the making of any clear and reliable conclusions.
METHODS


14 healthy males were supplemented for five days with 400 mg Mg to saturate Mg pools before intake of the test products. Bioavailability of 400 mg Mg from Mg citrate (MgC) and Mg oxide (MgO) after single-dose administration was assessed by measuring renal Mg excretion in 24-h urine and blood plasma [Mg] at time points 0, 2, 4, 8, and 24 h.
RESULTS


Single-dose MgC supplementation led to a significant (P < 0.05) increase in 24 h urinary Mg excretion, but this was not significant following MgO. Plasma [Mg] was also significantly higher for MgC than for MgO at 4 h (P < 0.05) and 8 h (P < 0.05). Compared with baseline levels, MgC supplementation showed a significant increase in plasma [Mg] at all time points, in contrast to MgO.
CONCLUSIONS


MgC shows higher bioavailability compared with MgO. Furthermore, urinary Mg excretion should be determined as the primary endpoint of Mg bioavailability studies.",2019,"Compared with baseline levels, MgC supplementation showed a significant increase in plasma [Mg] at all time points, in contrast to MgO.
CONCLUSIONS


MgC shows higher bioavailability compared with MgO. Furthermore, urinary Mg excretion should be determined as the primary endpoint of Mg bioavailability studies.","['Mg-saturated subjects', '14 healthy males']","['Bioavailability of 400\u2009mg Mg from Mg citrate (MgC) and Mg oxide (MgO', 'Mg from Mg citrate and Mg oxide']","['plasma [Mg', '24\u2009h urinary Mg excretion', 'renal Mg excretion in 24-h urine and blood plasma', 'urinary excretion']","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0126774', 'cui_str': 'magnesium citrate'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0042036', 'cui_str': 'Urine'}]",14.0,0.0357725,"Compared with baseline levels, MgC supplementation showed a significant increase in plasma [Mg] at all time points, in contrast to MgO.
CONCLUSIONS


MgC shows higher bioavailability compared with MgO. Furthermore, urinary Mg excretion should be determined as the primary endpoint of Mg bioavailability studies.","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Werner', 'Affiliation': 'NuOmix Research k.s. Applied Nutriomic Research, MartinSlovakia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kolisek', 'Affiliation': 'NuOmix Research k.s. Applied Nutriomic Research, MartinSlovakia, Comenius University in Bratislava, Jessenius Faculty of Medicine in Martin, Biomedical Center Martin, Division of Neurosciences, MartinSlovakia.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Vormann', 'Affiliation': 'NuOmix Research k.s. Applied Nutriomic Research, MartinSlovakia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Pilchova', 'Affiliation': 'Comenius University in Bratislava, Jessenius Faculty of Medicine in Martin, Biomedical Center Martin, Division of Neurosciences, MartinSlovakia.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Grendar', 'Affiliation': 'Comenius University in Bratislava, Jessenius Faculty of Medicine in Martin, Biomedical Center Martin, Department of Biostatistics, MartinSlovakia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Struharnanska', 'Affiliation': 'Comenius University in Bratislava, Faculty of Natural Sciences, Department of Molecular Biology, BratislavaSlovakia.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Cibulka', 'Affiliation': 'Comenius University in Bratislava, Jessenius Faculty of Medicine in Martin, Biomedical Center Martin, Division of Neurosciences, MartinSlovakia, Comenius University in Bratislava, Jessenius Faculty of Medicine in Martin, Institute of Medical Biochemistry, MartinSlovakia.'}]",Magnesium research,['10.1684/mrh.2019.0457']
3047,32441356,Fractional Radiofrequency Microneedling Combined With Fractional Carbon Dioxide Laser Treatment for Striae Distensae.,"BACKGROUND AND OBJECTIVES


To evaluate the safety and effectiveness of combined fractional radiofrequency microneedling (FRM) and fractional carbon dioxide (FCO 2  ) laser treatment for striae distensae and to compare the results to those of FRM alone and those of FCO 2  alone.
STUDY DESIGN/MATERIALS AND METHODS


Adult women (Fitzpatrick skin types III-IV) with striae distensae on the abdomen or calf were enrolled in this study. Each lesion was divided into three regions, with each region assigned to one of the three treatments (FCO 2  , FRM, or combined FCO 2  and FRM). Global photographic assessments were performed by three dermatologists and by patients using a scored visual analog scale (VAS). Additionally, each lesion was evaluated using a skin imaging analyzer and a diagnostic ultrasound system.
RESULTS


All 19 female subjects had an average body mass index of 23.85 kg/m 2  . The global assessment by dermatologists indicated a significant improvement in the combined treatment group (6.1) compared with the other groups (4.3 and 5.1 in the FRM and FCO 2  groups, respectively; P < 0.05), and that by the patients indicated a significant improvement in the combined treatment group (6.3) compared with the FRM group (5.1; P = 0.02). Ultrasound results showed significantly increased skin thickness and dermal density (204.9 μm and 8.8%; both P < 0.05) in the combined treatment group. However, results of the skin imaging analysis showed a higher average level of melanin and redness indices in the combined treatment group than in the FRM group (P < 0.001, P < 0.01, respectively), but not in the FCO 2  group (P = 0.15, P = 0.11, respectively).
CONCLUSION


Combined FRM and FCO 2  treatments resulted in slightly better clinical outcomes than single treatments, and the side effects of the treatment, such as pigmentation and persistent erythema, did not result in more serious events to a level similar to that of FCO 2  alone. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.",2020,Ultrasound results showed significantly increased skin thickness and dermal density (204.9 μm and 8.8%; both P < 0.05) in the combined treatment group.,"['All 19 female subjects had an average body mass index of 23.85\u2009kg/m 2  ', 'Striae Distensae', 'Adult women (Fitzpatrick skin types III-IV) with striae distensae on the abdomen or calf were enrolled in this study']","['FRM', 'Fractional Radiofrequency Microneedling Combined With Fractional Carbon Dioxide Laser Treatment', 'combined fractional\xa0radiofrequency microneedling (FRM) and fractional carbon dioxide (FCO 2  ) laser treatment']","['scored visual analog scale (VAS', 'average level of melanin and redness indices', 'Global photographic assessments', 'skin thickness and dermal density', 'pigmentation and persistent erythema']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0152459', 'cui_str': 'Linear atrophy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]",,0.038807,Ultrasound results showed significantly increased skin thickness and dermal density (204.9 μm and 8.8%; both P < 0.05) in the combined treatment group.,"[{'ForeName': 'Gi H', 'Initials': 'GH', 'LastName': 'Seong', 'Affiliation': 'Department of Dermatology, College of Medicine, Dankook University, 201, Manghyang-ro. Dongnam-gu, Cheonan-si, Chungcheongnam-do, 31116, Republic of Korea.'}, {'ForeName': 'Eun M', 'Initials': 'EM', 'LastName': 'Jin', 'Affiliation': 'Department of Dermatology, College of Medicine, Dankook University, 201, Manghyang-ro. Dongnam-gu, Cheonan-si, Chungcheongnam-do, 31116, Republic of Korea.'}, {'ForeName': 'Tae U', 'Initials': 'TU', 'LastName': 'Ryu', 'Affiliation': 'Department of Dermatology, College of Medicine, Dankook University, 201, Manghyang-ro. Dongnam-gu, Cheonan-si, Chungcheongnam-do, 31116, Republic of Korea.'}, {'ForeName': 'Myung H', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, College of Medicine, Dankook University, 201, Manghyang-ro. Dongnam-gu, Cheonan-si, Chungcheongnam-do, 31116, Republic of Korea.'}, {'ForeName': 'Byung C', 'Initials': 'BC', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, College of Medicine, Dankook University, 201, Manghyang-ro. Dongnam-gu, Cheonan-si, Chungcheongnam-do, 31116, Republic of Korea.'}, {'ForeName': 'Seung P', 'Initials': 'SP', 'LastName': 'Hong', 'Affiliation': 'Department of Dermatology, Yonsei University Wonju College of Medicine, Wonju-si, Gangwon-do, 26426, Republic of Korea.'}]",Lasers in surgery and medicine,['10.1002/lsm.23264']
3048,32440977,Persistence of Inflammation After Uncomplicated Cataract Surgery: A 6-Month Laser Flare Photometry Analysis.,"PURPOSE


To evaluate, by laser photometry, the persistency of anterior chamber flare after uneventful phacoemulsification in asymptomatic patients with no signs of inflammation on slit lamp examination.
METHOD


Seventy-five patients previously enrolled in a randomized clinical trial that evaluated inflammation after uneventful phacoemulsification in eyes treated with dexamethasone 0.1% ophthalmic suspension (group 1) or bromfenac 0.09% ophthalmic solution (group 2) for 2 weeks. Anterior chamber inflammation was investigated by laser flare photometry. At 30 days after surgery, laser flare showed persistently elevated values. For this reason, patients were further analyzed at 3 and 6 months. Additionally, optical coherence tomography was used to measure the central macular thickness (CMT) and to assess for postoperative pseudophakic macular edema.
RESULTS


When compared to preoperative values, laser flare photometry demonstrated persistent ocular inflammation at postoperative days 90 and 180 in group 1, but not in group 2. Laser flare values showed a significant reduction in group 2 compared to group 1 throughout all the follow-up (p < 0.001). The increase in mean CMT at days 90 and 180 with respect to baseline was statistically significant in group 1 but not in group 2, in which it decreased to levels similar to preoperative value. Group 1 showed a higher increase in mean CMT compared to group 2 throughout all the follow-up (p < 0.001). The proportion of patients that developed pseudophakic cystoid macular edema (CME) was 14% (n = 5) and 0% (n = 0) in group 1 and group 2, respectively (p = 0.02). The bivariate analysis demonstrated a positive correlation between laser flare and CMT values in group 1 but not in group 2.
CONCLUSION


Anterior chamber inflammation persists for more than 30 days in a significant proportion of patients after uncomplicated cataract surgery and may be responsible for late onset of cystoid macular edema cases.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03317847.",2020,Laser flare values showed a significant reduction in group 2 compared to group 1 throughout all the follow-up (p < 0.001).,"['asymptomatic patients with no signs of inflammation on slit lamp examination', 'Seventy-five patients previously enrolled']","['dexamethasone 0.1% ophthalmic suspension (group\xa01) or bromfenac 0.09% ophthalmic solution', 'optical coherence tomography']","['Anterior chamber inflammation', 'central macular thickness (CMT', 'pseudophakic cystoid macular edema (CME', 'Persistence of Inflammation', 'ocular inflammation', 'Laser flare values', 'mean CMT']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C4319621', 'cui_str': '75'}]","[{'cui': 'C0706574', 'cui_str': 'Dexamethasone 1 MG/ML Ophthalmic Suspension [Maxidex]'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1562105', 'cui_str': 'Bromfenac (as bromfenac sodium) 900 microgram/mL eye solution'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]","[{'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0024440', 'cui_str': 'Cystoid macular edema'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",75.0,0.0199933,Laser flare values showed a significant reduction in group 2 compared to group 1 throughout all the follow-up (p < 0.001).,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'De Maria', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Coassin', 'Affiliation': 'Ophthalmology, University Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Mastrofilippo', 'Affiliation': 'Clinical Trials and Statistics Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cimino', 'Affiliation': 'Ocular Immunology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Iannetta', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Fontana', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy. luifonta@gmail.com.'}]",Advances in therapy,['10.1007/s12325-020-01383-1']
3049,32441302,Comparison of ultrasound-guided supraclavicular and costoclavicular brachial plexus block using a modified double-injection technique: a randomized non-inferiority trial.,"Ultrasound-guided costoclavicular block (CC-approach) is a recently described brachial plexus block and an alternative approach to the supraclavicular approach (SC-approach). The relevant sonoanatomy is analogous in terms of the brachial plexus and its adjacent artery for both approaches. In this study, we hypothesized that the two approaches will result in similar block dynamics when used the modified double-injection (MDI) technique. 112 patients were randomly allocated to receive either a SC- or CC-approach with MDI technique. In the CC group, half the volume was injected adjacent to the medial cord of the brachial plexus, the procedure was guided by ultrasound and verified by nerve stimulator, subsequently the second half was injected close to the lateral cord. In the SC group, the MDI technique was carried out as described in our previous study. Sensory and motor blockade of all four terminal nerves were assessed with a 3-point scale. The primary outcome was the proportion of complete sensory blockade at 15 min with a predefined non-inferiority margin of -13%. The proportion of subjects at 15 min was comparable between the SC group and the CC group (91% vs 87%, absolute difference:-3%). No significant differences were found for complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events (all P>0.05). We conclude that the MDI technique applied to a costoclavicular and supraclavicular block resulted in similar block dynamics. In addition, it may provide a promising alternative technique when considering the use of multipoint injection.",2020,"No significant differences were found for complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events (all P>0.05).",['112 patients'],"['SC- or CC-approach with MDI technique', 'ultrasound-guided supraclavicular and costoclavicular brachial plexus block using a modified double-injection technique', 'Ultrasound-guided costoclavicular block (CC-approach']","['proportion of complete sensory blockade', 'complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",112.0,0.0308918,"No significant differences were found for complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events (all P>0.05).","[{'ForeName': 'Quehua', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Yao', 'Affiliation': 'The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yunfei', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': ""Guangdong Provincial People's Hospital, Guangzhou, China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hao', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Haihua', 'Initials': 'H', 'LastName': 'Shu', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.'}]",Bioscience reports,['10.1042/BSR20200084']
3050,31330252,PROMIS 4-item measures and numeric rating scales efficiently assess SPADE symptoms compared with legacy measures.,"OBJECTIVE


The 5 SPADE (sleep, pain, anxiety, depression, and low energy/fatigue) symptoms are among the most prevalent and disabling symptoms in clinical practice. This study evaluates the minimally important difference (MID) of Patient-Reported Outcomes Measurement Information System (PROMIS) measures and their correspondence with other brief measures to assess SPADE symptoms.
STUDY DESIGN AND SETTING


Three hundred primary care patients completed a 4-item PROMIS scale, a numeric rating scale (NRS), and a non-PROMIS legacy scale for each of the 5 SPADE symptoms. Optimal NRS cutpoints were examined, and cross-walk units for converting legacy measure scores to PROMIS scores were determined. PROMIS scores corresponding to standard deviation (SD) and standard error of measurement (SEM) changes in legacy scores were used to estimate MID.
RESULTS


At an NRS ≥5, the mean PROMIS T-score exceeded 55 (the operational threshold for a clinically meaningful symptom) for each SPADE symptom. Correlations were high (0.70-0.86) between each PROMIS scale and its corresponding non-PROMIS legacy scale. Changes in non-PROMIS legacy scale scores of 0.35 SD and 1 SEM corresponded to mean PROMIS T-scores of 2.92 and 3.05 across the 5 SPADE symptoms, with changes in 0.2 and 0.5 SD corresponding to mean PROMIS T-scores of 1.67 and 4.16.
CONCLUSION


A 2-step screening process for SPADE symptoms might use single-item NRS scores, proceeding to PROMIS scales for NRS scores ≥5. A PROMIS T-score change of three points represents a reasonable MID estimate, with two to four points approximating lower and upper bounds.",2019,Correlations were high (0.70-0.86) between each PROMIS scale and its corresponding non-PROMIS legacy scale.,"['Three hundred primary care patients completed a 4-item PROMIS scale, a numeric rating scale (NRS), and a non-PROMIS legacy scale for each of the 5 SPADE symptoms']",[],"['mean PROMIS T-score', '5 SPADE (sleep, pain, anxiety, depression, and low energy/fatigue) symptoms', 'PROMIS scores corresponding to standard deviation (SD) and standard error of measurement (SEM) changes in legacy scores', 'non-PROMIS legacy scale scores']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0242538', 'cui_str': 'Inheritance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242538', 'cui_str': 'Inheritance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",300.0,0.0203288,Correlations were high (0.70-0.86) between each PROMIS scale and its corresponding non-PROMIS legacy scale.,"[{'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kroenke', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN, USA; Regenstrief Institute, Inc., Indianapolis, IN, USA. Electronic address: kkroenke@regenstrief.org.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Stump', 'Affiliation': 'Department of Biostatistics, Indiana University Fairbanks School of Public Health and School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Kean', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Tasneem L', 'Initials': 'TL', 'LastName': 'Talib', 'Affiliation': 'Regenstrief Institute, Inc., Indianapolis, IN, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Haggstrom', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN, USA; Regenstrief Institute, Inc., Indianapolis, IN, USA; VA Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Patrick O', 'Initials': 'PO', 'LastName': 'Monahan', 'Affiliation': 'Department of Biostatistics, Indiana University Fairbanks School of Public Health and School of Medicine, Indianapolis, IN, USA.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.06.018']
3051,31840263,Randomized controlled trial of family-focused treatment for child depression compared to individual psychotherapy: one-year outcomes.,"OBJECTIVE


Childhood-onset depression is associated with increased risk of recurrent depression and high morbidity extending into adolescence and adulthood. This multisite randomized controlled trial evaluated two active psychosocial treatments for childhood depression: family-focused treatment for childhood depression (FFT-CD) and individual supportive psychotherapy (IP). Aims were to describe effects through 52 weeks postrandomization on measures of depression, functioning, nondepressive symptoms, and harm events.
METHODS


Children meeting criteria for depressive disorders (N = 134) were randomly assigned to 15 sessions of FFT-CD or IP and evaluated at mid-treatment for depressive symptoms and fully at roughly 16 weeks (after acute treatment), 32 weeks, and 52 weeks/one year. See clinicaltrials.gov: NCT01159041.
RESULTS


Analyses using generalized linear mixed models confirmed the previously reported FFT-CD advantage on rates of acute depression response (≥50% Children's Depression Rating Scale reduction). Improvements in depression and other outcomes were most rapid during the acute treatment period, and leveled off between weeks 16 and 52, with a corresponding attenuation of observed group differences, although both groups showed improved depression and functioning over 52 weeks. Survival analyses indicated that most children recovered from their index depressive episodes by week 52: estimated 76% FFT-CD, 77% IP. However, by the week 52 assessment, one FFT-CD child and six IP children had suffered recurrent depressive episodes. Four children attempted suicide, all in the IP group. Other indicators of possible harm were relatively evenly distributed across groups.
CONCLUSIONS


Results indicate a quicker depression response in FFT-CD and hint at greater protection from recurrence and suicide attempts. However, outcomes were similar for both active treatments by week 52/one year. Although community care received after acute treatment may have influenced results, findings suggest the value of a more extended/chronic disease model that includes monitoring and guidance regarding optimal interventions when signs of depression-risk emerge.",2020,"Improvements in depression and other outcomes were most rapid during the acute treatment period, and leveled off between weeks 16 and 52, with a corresponding attenuation of observed group differences, although both groups showed improved depression and functioning over 52 weeks.","['childhood depression', 'Children meeting criteria for depressive disorders (N\xa0=\xa0134']","['individual psychotherapy', 'FFT-CD or IP and evaluated at mid-treatment', 'childhood depression (FFT-CD) and individual supportive psychotherapy (IP']","['suffered recurrent depressive episodes', 'FFT-CD advantage on rates of acute depression response', 'depression, functioning, nondepressive symptoms, and harm events', 'depression and functioning', 'index depressive episodes']","[{'cui': 'C2363919', 'cui_str': 'Childhood depression'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}]","[{'cui': 'C0204525', 'cui_str': 'Individual psychotherapy (regime/therapy)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2363919', 'cui_str': 'Childhood depression'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C1386135', 'cui_str': 'Acute depression'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0670798,"Improvements in depression and other outcomes were most rapid during the acute treatment period, and leveled off between weeks 16 and 52, with a corresponding attenuation of observed group differences, although both groups showed improved depression and functioning over 52 weeks.","[{'ForeName': 'Joan Rosenbaum', 'Initials': 'JR', 'LastName': 'Asarnow', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Martha C', 'Initials': 'MC', 'LastName': 'Tompson', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Klomhaus', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Kalina', 'Initials': 'K', 'LastName': 'Babeva', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Langer', 'Affiliation': 'Suffolk University, Boston, MA, USAsa.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sugar', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13162']
3052,32441031,Electrocautery Needling and the 308-nm Excimer Lamp: A Synergistic Combination for the Treatment of Stable Non-segmental Vitiligo.,"INTRODUCTION


Vitiligo is an acquired chronic depigmentation disorder caused by the destruction of melanocytes. Although various treatments have been proposed for the management of vitiligo, achieving repigmentation and preventing relapse remains challenging. The aim of the study was to evaluate the effectiveness of electrocautery needling (EC needling) as a treatment for stable non-segmental vitiligo and to determine if the effectiveness of this treatment could be enhanced by combining it with the 308-nm excimer lamp (excimer lamp).
METHODS


Thirty patients with stable non-segmental vitiligo were enrolled in this self-controlled, non-blinded study. Three vitiligo lesions of similar size, location and disease duration were selected from each patient and randomly assigned to one of three groups treated weekly with EC needling, an excimer lamp or a combination of both (combination group), respectively. The effectiveness of treatment on the repigmentation percentage and the number of treatments required for initial pigmentation were assessed.
RESULTS


There was no significant difference in the repigmentation percentage between the EC needling group and the excimer lamp group (P = 0.789). The mean number of treatments required for initial repigmentation was lower in the EC needling group than in the excimer lamp group (P = 0.049). The repigmentation percentage was significantly higher in the combination group than in the EC needling group (P = 0.027) and excimer lamp group (P = 0.005). Evidence of initial pigmentation was obtained earlier in lesions treated with the combination therapy than in lesions treated with excimer lamp therapy alone (P = 0.019). Vitiligo lesions on the face and neck regions showed the highest repigmentation percentage among all anatomical regions, whereas lesions on the hands and feet showed the worst treatment response.
CONCLUSION


Electrocautery needling monotherapy was effective in treating vitiligo, and its efficacy was enhanced when combined with the 308-nm excimer lamp. This combined approach to treat vitiligo is safe and helps increase patient compliance.",2020,There was no significant difference in the repigmentation percentage between the EC needling group and the excimer lamp group (P = 0.789).,"['Thirty patients with stable non-segmental vitiligo', 'Stable Non-segmental Vitiligo', 'stable non-segmental vitiligo']","['excimer lamp therapy', 'Electrocautery needling monotherapy', 'Electrocautery Needling and the 308-nm Excimer Lamp', 'excimer lamp', '308-nm excimer lamp (excimer lamp', 'electrocautery needling (EC needling', 'EC needling, an excimer lamp or a combination of both (combination group']","['repigmentation percentage', 'Vitiligo lesions', 'mean number of treatments required for initial repigmentation', 'initial pigmentation']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1274648', 'cui_str': 'Segmental vitiligo'}]","[{'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332121', 'cui_str': 'Treatment required for'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}]",30.0,0.0265379,There was no significant difference in the repigmentation percentage between the EC needling group and the excimer lamp group (P = 0.789).,"[{'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Pui Mun', 'Initials': 'PM', 'LastName': 'Wong', 'Affiliation': 'Department of Dermatology, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Pigmentation Research and Therapeutics, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Katayama', 'Affiliation': 'Department of Pigmentation Research and Therapeutics, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Huali', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of TCM Chemistry, School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China. zhanghm@shutcm.edu.cn.'}]",Dermatology and therapy,['10.1007/s13555-020-00395-7']
3053,32441198,"Effects of Vitamin D and Omega-3 Fatty Acids Co-Supplementation on Inflammatory Factors and Tumor Marker CEA in Colorectal Cancer Patients Undergoing Chemotherapy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","Objectives:  This study aimed to investigate the effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory factors and tumor marker CEA in colorectal cancer patients undergoing chemotherapy. Methods:  In this study, 81 patients with stage ӀӀ or ӀӀӀ colorectal cancer were randomly assigned into four groups: (1) control: receiving a vitamin D placebo, weekly + two omega-3 fatty acid placebo capsules, daily; (2) omega-3 fatty acid, receiving two omega-3 fatty acid capsules (each capsule containing 330 mg of omega-3 fatty acids), daily + a vitamin D placebo, weekly; (3) vitamin D, receiving a 50,000 IU vitamin D soft gel, weekly + two omega-3 fatty acid placebo capsules, daily; (4) co-supplementation, receiving a 50,000 IU vitamin D soft gel, weekly + two omega-3 fatty acids capsules, for 8 weeks. Before and after the intervention, serum levels of 25(OH)D, TNF-α, IL-1β, IL-6, IL-8, NF-kB activity, and tumor marker CEA, were measured. Results:  After 8 weeks of intervention, patients who received combined vitamin D and omega-3 fatty acids supplements compared with omega-3, vitamin D, and placebo had significantly decreased TNF-α, and IL-1β ( P  < .05). In addition, serum levels of TNF-α, IL-1β, IL-6, IL-8, and tumor marker CEA were decreased significantly in omega-3, vitamin D, and co-supplementation of them, compared with baseline. NF-kB activity was decreased significantly in vitamin D and co-supplementation groups, compared with baseline. Regarding CEA, there was no significant difference between the four groups at the end of intervention ( P  > .05). Conclusion:  Results show that co-supplementation of vitamin D and omega-3 fatty acids co-supplementation, in colorectal cancer patients have beneficial impacts on inflammation and tumor marker CEA.",2020,"Regarding CEA, there was no significant difference between the four groups at the end of intervention ( P  > .05).","['colorectal cancer patients', 'colorectal cancer patients undergoing chemotherapy', 'Colorectal Cancer Patients', '81 patients with stage ӀӀ or ӀӀӀ colorectal cancer']","['Placebo', 'vitamin D placebo, weekly\u2009+\u2009two omega-3 fatty acid placebo capsules, daily; (2) omega-3 fatty acid, receiving two omega-3 fatty acid capsules (each capsule containing 330\u2009mg of omega-3 fatty acids), daily\u2009+\u2009a vitamin D placebo, weekly; (3) vitamin D, receiving a 50,000\u2009IU vitamin D soft gel, weekly\u2009+\u2009two omega-3 fatty acid placebo capsules, daily; (4) co-supplementation, receiving a 50,000\u2009IU vitamin D soft gel, weekly\u2009+\u2009two omega-3 fatty acids capsules', 'Undergoing Chemotherapy', 'combined vitamin D and omega-3 fatty acids supplements compared with omega-3, vitamin D, and placebo', 'Vitamin D and Omega-3 Fatty Acids Co-Supplementation', 'vitamin D and omega-3 fatty acids co-supplementation']","['serum levels of TNF-α, IL-1β, IL-6, IL-8, and tumor marker CEA', 'serum levels of 25(OH)D, TNF-α, IL-1β, IL-6, IL-8, NF-kB activity, and tumor marker CEA', 'inflammatory factors and tumor marker CEA', 'NF-kB activity', 'TNF-α, and IL-1β', 'Inflammatory Factors and Tumor Marker CEA']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0310589', 'cui_str': 'Vitamin A- and vitamin D-containing product'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",81.0,0.302644,"Regarding CEA, there was no significant difference between the four groups at the end of intervention ( P  > .05).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Haidari', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Abiri', 'Affiliation': 'Department of Nutrition, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Iravani', 'Affiliation': 'Department of Medical Oncology and Hematology, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi-Angali', 'Affiliation': 'Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}]",Nutrition and cancer,['10.1080/01635581.2019.1659380']
3054,32441331,Moderators of Cognitive Outcomes from an Exercise Program in People with Mild to Moderate Dementia.,"BACKGROUND/OBJECTIVES


Our aim was to estimate whether baseline participant variables were able to moderate the effect of an exercise intervention on cognition in patients with mild to moderate dementia.
DESIGN


Subgroup analysis of a multicenter pragmatic randomized controlled trial.
SETTING


Community-based gym/rehabilitation centers.
PARTICIPANTS


A total of 494 community-dwelling participants with mild to moderate dementia.
INTERVENTION


Participants were randomized to a moderate- to high-intensity aerobic and strength exercise program or a usual care control group. Experimental group participants attended twice weekly 60- to 90-minute gym sessions for 4 months. Participants were prescribed home exercises for an additional hour per week during the supervised period and 150 minutes each week after the supervised period.
MEASUREMENTS


Multilevel regression model analyses were undertaken to identify individual moderators of cognitive function measured through the Alzheimer Disease Assessment Scale-Cognitive Subscale score at 12 months.
RESULTS


When tested for a formal interaction effect, only cognitive function assessed by the baseline number cancellation test demonstrated a statistically significant interaction effect (-2.7 points; 95% confidence interval = -5.14 to -0.21).
CONCLUSION


People with worse number cancellation test scores may experience greater progression of cognitive decline in response to a moderate- to high-intensity exercise program. Further analyses to examine whether these findings can be replicated in planned sufficiently powered analyses are indicated.",2020,"When tested for a formal interaction effect, only cognitive function assessed by the baseline number cancellation test demonstrated a statistically significant interaction effect (-2.7 points; 95% confidence interval = -5.14 to -0.21).
","['People with Mild to Moderate Dementia', 'patients with mild to moderate dementia', 'Community-based gym/rehabilitation centers', 'A total of 494 community-dwelling participants with mild to moderate dementia']","['Exercise Program', 'exercise intervention', 'moderate- to high-intensity aerobic and strength exercise program or a usual care control group']",['individual moderators of cognitive function measured through the Alzheimer Disease Assessment Scale-Cognitive Subscale score'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",494.0,0.100024,"When tested for a formal interaction effect, only cognitive function assessed by the baseline number cancellation test demonstrated a statistically significant interaction effect (-2.7 points; 95% confidence interval = -5.14 to -0.21).
","[{'ForeName': 'Toby O', 'Initials': 'TO', 'LastName': 'Smith', 'Affiliation': 'Nuffield Department of Orthopaedics Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dipesh', 'Initials': 'D', 'LastName': 'Mistry', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Hopin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Nuffield Department of Orthopaedics Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sukhdeep', 'Initials': 'S', 'LastName': 'Dosanji', 'Affiliation': 'Creavo Medical Technologies, Coventry, UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Finnegan', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Fordham', 'Affiliation': 'Nuffield Department of Orthopaedics Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Vivien P', 'Initials': 'VP', 'LastName': 'Nichols', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Sheehan', 'Affiliation': 'Arden Mental health Acute Team, Coventry and Warwickshire Partnership Trust, Coventry, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16552']
3055,32441353,Traumatic injury results in prolonged circulation of ultralarge von Willebrand factor and a reduction in ADAMTS13 activity.,"BACKGROUND


Increases in plasma von Willebrand Factor (VWF) levels, accompanied by decreases in the metalloprotease ADAMTS13, have been demonstrated soon after traumatic injury while downstream effects remain unclear.
STUDY DESIGN AND METHODS


A cohort of 37 injured trauma patients from a randomized control trial investigating the use of prehospital plasma transfusion were analyzed for activity and antigen levels of ADAMTS13 and VWF at 0 and 24 hours after admission. Relevant clinical data were abstracted from the medical records. Trauma patient plasma was analyzed via agarose gel electrophoresis to evaluate the effects of injury on VWF multimer composition compared to healthy controls.
RESULTS


von Willebrand factor levels were elevated at presentation (189% [110%-263%] vs. 95% [74%-120%]), persisting through 24 hours (213% [146%-257%] vs. 132% [57%-160%]), compared to healthy controls. Ultralarge VWF (UL-VWF) forms were elevated in trauma patients at both 0 and 24 hours, when compared to pooled normal plasma (10.0% [8.9%-14.3%] and 11.3% [9.1%-21.2%], respectively, vs. 0.6%). Circulating plasma ADAMTS13 activity was decreased at 0 hours (66% [47%-86%] vs. 100% [98%-100%]) and at 24 hours (72.5% [56%-87.3%] vs. 103% [103%-103%]) in trauma patients. ADAMTS13 activity independently predicted the development of coagulopathy and correlated with international normalized ratio, thromboelastography values, injury severity, and blood product transfusion.
CONCLUSION


Traumatic injury is associated with acute coagulopathy that is characterized by increased UL-VWF multimers and reduction in ADAMTS13, which correlates with blood loss, transfusion requirement, and injury severity. These findings suggest the potential for future trials targeting ADAMTS13 repletion to enhance clearance of VWF multimers.",2020,"Ultralarge VWF (UL-VWF) forms were elevated in trauma patients at both 0 and 24 hours, when compared to pooled normal plasma (10.0% [8.9%-14.3%] and 11.3% [9.1%-21.2%], respectively, vs. 0.6%).",['A cohort of 37 injured trauma patients'],[],"['Circulating plasma ADAMTS13 activity', 'international normalized ratio, thromboelastography values, injury severity, and blood product transfusion', 'activity and antigen levels of ADAMTS13 and VWF', 'von Willebrand factor levels', 'plasma von Willebrand Factor (VWF) levels', 'Ultralarge VWF (UL-VWF']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0430420', 'cui_str': 'Antigen assay'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0851611,"Ultralarge VWF (UL-VWF) forms were elevated in trauma patients at both 0 and 24 hours, when compared to pooled normal plasma (10.0% [8.9%-14.3%] and 11.3% [9.1%-21.2%], respectively, vs. 0.6%).","[{'ForeName': 'Mitchell R', 'Initials': 'MR', 'LastName': 'Dyer', 'Affiliation': 'Pittsburgh Trauma Research Center and the Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Plautz', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Margaret V', 'Initials': 'MV', 'LastName': 'Ragni', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Wyeth', 'Initials': 'W', 'LastName': 'Alexander', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Haldeman', 'Affiliation': 'Pittsburgh Trauma Research Center and the Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'Pittsburgh Trauma Research Center and the Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Zuckerbraun', 'Affiliation': 'Pittsburgh Trauma Research Center and the Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Marian A', 'Initials': 'MA', 'LastName': 'Rollins-Raval', 'Affiliation': 'Department of Pathology, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Raval', 'Affiliation': 'Department of Pathology, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': 'Pittsburgh Trauma Research Center and the Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transfusion,['10.1111/trf.15856']
3056,32441171,Influence of Different Rehydration Protocols on Biomechanical Properties of Allogeneic Cortical Bone Plates: A Combined  in-vitro / in-vivo  Study.,"Introduction:  Allogeneic cortical bone plates (CP) are used for alveolar ridge augmentation. Since CP are freeze-dried and dehydrated during processing, the breaking strength (BS) and the flexibility (FX) are reduced, resulting in a relevant risk for plate fractures during insertion. The aim of this study was to evaluate the influence of rehydration time on the biomechanical properties (BS & FX) of CP  in-vitro  and  in vivo . Material and Methods:  40 CP were randomly divided into four experimental groups. (A) untreated control (n = 10), rehydration for 10 (B), 30 (C) and 60 (D) minutes in 0.9% saline solution (n = 10 each). BS [Newton, N] and FX [mm] (force till fracture and distance of deflection to the breaking point) were analyzed. Besides, architectural features of all CP groups were visualized and examined by scanning electron microscopy (SEM). In addition, the frequency of CP fractures of rehydrated- vs. non-rehydrated CP was retrospectively analyzed in 6 patients. Results:  Compared to the control group, significantly increased BS and FX were demonstrated after 10, 30 and 60 minutes of rehydration (p each ≤ 0.035). After a rehydration time of 10 minutes, no additional increase of BS and FX was seen when compared to30 and 60 minutes (p each = 1.0). SEM scans demonstrated that the CP fracture characteristics were influenced by the different rehydration protocols. The frequency of CP fractures was reduced in patients by CP rehydration. Conclusion:  The biomechanical properties of CP can be significantly improved by 10 min of rehydration, resulting in an increased BS and FX, that might be clinically relevant.",2020,"Compared to the control group, significantly increased BS and FX were demonstrated after 10, 30 and 60 minutes of rehydration (p each ≤ 0.035).",['40 CP'],['Allogeneic cortical bone plates (CP'],"['CP fracture characteristics', 'BS and FX', 'breaking strength (BS) and the flexibility (FX', 'frequency of CP fractures', 'Biomechanical Properties of Allogeneic Cortical Bone Plates']",[],"[{'cui': 'C0222652', 'cui_str': 'Cortex of bone'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}]",,0.0180156,"Compared to the control group, significantly increased BS and FX were demonstrated after 10, 30 and 60 minutes of rehydration (p each ≤ 0.035).","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pabst', 'Affiliation': 'Department of Oral- and Maxillofacial Surgery, Federal Armed Forces Hospital, Koblenz, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Ackermann', 'Affiliation': 'Institute of Functional and Clinical Anatomy, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Thiem', 'Affiliation': 'Department of Oral- and Maxillofacial Surgery, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Peer', 'Initials': 'P', 'LastName': 'Kämmerer', 'Affiliation': 'Department of Oral- and Maxillofacial Surgery, University Medical Center, Mainz, Germany.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2020.1767735']
3057,32441386,Different freezing time of superficial liquid nitrogen cryotherapy in treatment of recalcitrant alopecia areata: Randomized Clinical Trial.,"Recalcitrant alopecia areata is not uncommon in clinical practice and some patients experienced either treatment failure or recurrence with most of the conventional therapies. Several studies have evaluated the efficacy of cryotherapy in the treatment of alopecia areata with controversial results. This study aimed to optimize the ideal timing of liquid nitrogen cryospraying to achieve the most favorable results. A total of 75 patients with recalcitrant alopecia areata were treated with superficial cryotherapy, two freeze- thaw cycles, each consisted of 3-5, 8-10 and 13-15 seconds in group A, B and C, respectively. Good to moderate improvement was achieved in 65.2%, 76% and 76.2% in groups A, B and C, respectively, with no statistically significant difference. However, the mean percentage of improvement was significantly higher in group B and C compared to group A (p value <0.05 for each). Superficial liquid nitrogen cryotherapy is an effective therapeutic modality for recalcitrant alopecia areata. Moreover, using 8-10 seconds dual freeze-thaw cycles is the optimum timing. This article is protected by copyright. All rights reserved.",2020,"However, the mean percentage of improvement was significantly higher in group B and C compared to group A (p value <0.05 for each).","['75 patients with recalcitrant alopecia areata', 'recalcitrant alopecia areata']","['Superficial liquid nitrogen cryotherapy', 'superficial liquid nitrogen cryotherapy', 'cryotherapy', 'superficial cryotherapy']","['Recalcitrant alopecia areata', 'mean percentage of improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0260055', 'cui_str': 'Liquid nitrogen'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",75.0,0.0145758,"However, the mean percentage of improvement was significantly higher in group B and C compared to group A (p value <0.05 for each).","[{'ForeName': 'Amira A', 'Initials': 'AA', 'LastName': 'Abdel Motaleb', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Assiut University, Egypt.'}, {'ForeName': 'Doaa S', 'Initials': 'DS', 'LastName': 'Sayed', 'Affiliation': 'Dermatology and Andrology Department, Faculty of Medicine, Assiut University, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13640']
3058,32441467,"Moist exposed burn therapy in recovery of patients with immature, red hypertrophic scars successfully treated with a pulsed dye laser in combination with a fractional CO 2  laser.","BACKGROUND


The efficacy of pulsed dye laser combined (PDL) and UltraPulse fractional CO 2  in treatment of hypertrophic scars is well documented. The present study investigates the efficacy of moist exposed burn ointment (MEBO)/moist exposed burn therapy (MEBT) in postlaser wound management.
METHODS


Sixty-one patients with immature, red hypertrophic scars were enrolled in this clinical trial. Patients were randomly divided into two groups: (a) the MEBO treatment group (n = 30) and (b) the control group (n = 31) treated with chlortetracycline hydrochloride ointment. Demographic data such as age, gender, and cause of scars were recorded. A visual analogue score (VAS) was collected to measure pain at 1, 6, 24, 72 hours, and 7 days post-treatment. The Vancouver Scar Scale (VSS) was used to determine the response of the scars before and 3 months after the treatment. The wound healing time and pigmentation scores were also recorded.
RESULTS


No significant differences were found in age, gender, and etiology of the scars in the two groups. The VAS scores in MEBO group were significantly lower than the control group within the first 3 days after treatment. The wound healing time of the MEBO group was significantly shorter than the control group. For both groups, VSS scores were significantly decreased and the scar markedly improved. However, the VSS scores were significantly lower in the MEBO group compared with the control group 3 months after treatment and pigmentation formation was dramatically lower in MEBO group compared with the control.
CONCLUSION


MEBT/MEBO treatment reduced the post-treatment pain, shortened the wound healing duration, promoted the overall scar condition, and reduced the incidence of pigmentation.",2020,"However, the VSS scores were significantly lower in the MEBO group compared with the control group 3 months after treatment and pigmentation formation was dramatically lower in MEBO group compared with the control.
","['patients with immature, red hypertrophic scars', 'Sixty-one patients with immature, red hypertrophic scars']","['pulsed dye laser in combination with a fractional CO 2  laser', 'moist exposed burn ointment (MEBO)/moist exposed burn therapy (MEBT', 'MEBO treatment', 'MEBO', 'Moist exposed burn therapy', 'pulsed dye laser combined (PDL', 'chlortetracycline hydrochloride ointment', 'MEBT/MEBO']","['A visual analogue score (VAS', 'wound healing duration', 'overall scar condition', 'wound healing time', 'pigmentation formation', 'Vancouver Scar Scale (VSS', 'incidence of pigmentation', 'wound healing time and pigmentation scores', 'VSS scores', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C4517832', 'cui_str': '61'}]","[{'cui': 'C1289859', 'cui_str': 'Pulsed dye laser device'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C1174850', 'cui_str': 'moist exposed burn ointment'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0085855', 'cui_str': 'Chlortetracycline hydrochloride'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",61.0,0.0151803,"However, the VSS scores were significantly lower in the MEBO group compared with the control group 3 months after treatment and pigmentation formation was dramatically lower in MEBO group compared with the control.
","[{'ForeName': 'Xiao-Jia', 'Initials': 'XJ', 'LastName': 'Liu', 'Affiliation': ""Department of Plastic & Laser Cosmetic, Hunan Provincial People's Hospital, Changsha City, China.""}, {'ForeName': 'Hua-Wei', 'Initials': 'HW', 'LastName': 'Ouyang', 'Affiliation': ""Department of Plastic & Laser Cosmetic, Hunan Provincial People's Hospital, Changsha City, China.""}, {'ForeName': 'Ying-', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Plastic & Laser Cosmetic, Hunan Provincial People's Hospital, Changsha City, China.""}, {'ForeName': 'Yi-Ling', 'Initials': 'YL', 'LastName': 'Yu', 'Affiliation': ""Department of Plastic & Laser Cosmetic, Hunan Provincial People's Hospital, Changsha City, China.""}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Gold', 'Affiliation': 'Gold Skin Care Center, Nashville, TN, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': ""Department of Plastic & Laser Cosmetic, Hunan Provincial People's Hospital, Changsha City, China.""}]",Journal of cosmetic dermatology,['10.1111/jocd.13426']
3059,31451902,Clinical outcome and success rates of ACI for cartilage defects of the patella: a subgroup analysis from a controlled randomized clinical phase II trial (CODIS study).,"AIM


Cartilage defects of the patella are considered as a problematic entity. Purpose of the present study was to evaluate the outcome of patients treated with autologous chondrocyte implantation (ACI) for cartilage defects of the patella in comparison to patient with defects of the femoral condyles.
PATIENTS AND METHODS


73 patients with a follow-up of 5 years have been included in this subgroup analysis of the randomized controlled clinical trial (RCT). In dependence of defect location, patients were divided into two groups [patella defects (n = 45) and femoral condyle defects (n = 28)]. Clinical outcome was evaluated by the means of the KOOS score at baseline and 6 weeks, 3, 6, 12, 18, 24, 36, 48 and 60 months following ACI.
RESULTS


""Responder rate"" at 60 months (improvement from baseline of > 7 points in the KOOS score) in patients with patella defects was 86.2%. All scores showed a significant improvement from baseline. While overall KOOS score at 60 months was 81.9 (SD 18.6) points in femoral condyle defects, a mean of 82.6 (SD 14.0) was observed in patella defects (p = 0.2483).
CONCLUSION


ACI seems an appropriate surgical treatment for cartilage defects of the patella leading to a high success rate. In this study, the clinical outcome in patients with patellar defects was even better than the already excellent results in patients with defects of the femoral condyle even though the study included relatively large defect sizes for both groups (mean defect size 6.0 ± 1.7 and 5.4 ± 1.6 for femur and patella, respectively).",2020,"While overall KOOS score at 60 months was 81.9 (SD 18.6) points in femoral condyle defects, a mean of 82.6","['patients with patellar defects', '73 patients with a follow-up of 5\xa0years']","['autologous chondrocyte implantation (ACI', 'ACI']","['KOOS score', 'overall KOOS score', 'patella defects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0540404', 'cui_str': 'adenylyl cyclase type I'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030647', 'cui_str': 'Kneecap'}, {'cui': 'C0243067', 'cui_str': 'defects'}]",73.0,0.129378,"While overall KOOS score at 60 months was 81.9 (SD 18.6) points in femoral condyle defects, a mean of 82.6","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Niemeyer', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Freiburg University Hospital, Germany and OCM Clinic, OCM | Orthopädische Chirurgie München, Steinerstrass 6, 83069, Munich, Germany. phniemeyer@gmail.com.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Laute', 'Affiliation': 'Joint and Spine Centre, Berlin, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Zinser', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, St. Vinzenz-Hospital, Dinslaken, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Becher', 'Affiliation': 'Department of Orthopedic Surgery, Medical University Annastift Hanover, Hanover, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Diehl', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Orthopedic Center Munich East, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kolombe', 'Affiliation': 'Traumatology and Reconstructive Surgery, DRK Hospital Luckenwalde, Luckenwalde, Germany.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Fay', 'Affiliation': 'Department of Traumatology and Arthroscopic Surgery, Lubinus Clinicum Kiel, Kiel, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Siebold', 'Affiliation': 'Center for Hip, Knee and Foot Surgery, ATOS Clinic Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Fickert', 'Affiliation': 'Sporthopaedicum Straubing, Straubing, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-019-03264-x']
3060,31268469,Effect of Aerobic and Resistance Exercise on Cardiac Adipose Tissues: Secondary Analyses From a Randomized Clinical Trial.,"Importance


Epicardial and pericardial adipose tissues are emerging as important risk factors for cardiovascular disease, and there is a growing interest in discovering strategies to reduce the accumulation of fat in these depots.
Objective


To investigate whether a 12-week endurance or resistance training intervention regulates epicardial and pericardial adipose tissue mass.
Design, Setting, and Participants


Secondary analysis of a randomized, assessor-blinded clinical trial initiated on August 2016 and completed April 2018. This single-center, community-based study included 50 physically inactive participants with abdominal obesity.
Interventions


Participants were randomized to a supervised high-intensity interval endurance training (3 times a week for 45 minutes), resistance training (3 times a week for 45 minutes), or no exercise (control group).
Main Outcomes and Measures


Change in epicardial and pericardial adipose tissue mass assessed by magnetic resonance imaging, based on a prespecified secondary analysis plan including 3 of 5 parallel groups.
Results


Of 50 participants (mean [SD] age, 41 [14] years, 10 men [26%]; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 32 [5]), 39 [78%] completed the study. Endurance training and resistance training reduced epicardial adipose tissue mass by 32% (95% CI, 10%-53%) and 24% (95% CI, 1%-46%), respectively, compared with the no exercise control group (56% [95% CI, 24%-88%]; P = .001 and 48% [95% CI, 15%-81%]; P < .001, respectively). While there was a nonsignificant reduction in pericardial adipose tissue mass after endurance training (11% [95% CI, -5% to 27%]; P = .17), resistance training significantly reduced pericardial adipose tissue mass by 31% (95% CI, 16%-47%; P < .001) when compared with the no exercise control group. Compared with the no exercise control group, there was an increase in left ventricular mass by endurance (20 g [95% CI, 11%-30%]; P < .001) and resistance training (18 g [95% CI, 8%-28%]; P < .001). Other cardiometabolic outcomes remained unchanged after the 12-week trial period.
Conclusions and Relevance


In individuals with abdominal obesity, both endurance and resistance training reduced epicardial adipose tissue mass, while only resistance training reduced pericardial adipose tissue mass. These data highlight the potential preventive importance of different exercise modalities as means to reduce cardiac fat in individuals with abdominal obesity.
Trial Registration


ClinicalTrials.gov identifier: NCT02901496.",2019,"Endurance training and resistance training reduced epicardial adipose tissue mass by 32% (95% CI, 10%-53%) and 24% (95% CI, 1%-46%), respectively, compared with the no exercise control group (56% [95% CI, 24%-88%]; P = .001 and 48% [95% CI, 15%-81%]; P < .001, respectively).","['individuals with abdominal obesity', 'Cardiac Adipose Tissues', '50 participants (mean [SD] age', '50 physically inactive participants with abdominal obesity', '41 [14] years, 10 men [26%]; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 32 [5]), 39 [78%] completed the study']","['supervised high-intensity interval endurance training', 'endurance or resistance training intervention', 'Endurance training and resistance training', 'Aerobic and Resistance Exercise', 'resistance training (3\u2009times a week for\u200945 minutes), or no exercise (control group']","['epicardial and pericardial adipose tissue mass', 'pericardial adipose tissue mass', 'epicardial adipose tissue mass', 'left ventricular mass by endurance', 'resistance training']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0442031', 'cui_str': 'Pericardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",50.0,0.183365,"Endurance training and resistance training reduced epicardial adipose tissue mass by 32% (95% CI, 10%-53%) and 24% (95% CI, 1%-46%), respectively, compared with the no exercise control group (56% [95% CI, 24%-88%]; P = .001 and 48% [95% CI, 15%-81%]; P < .001, respectively).","[{'ForeName': 'Regitse Højgaard', 'Initials': 'RH', 'LastName': 'Christensen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Wedell-Neergaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Louise Lang', 'Initials': 'LL', 'LastName': 'Lehrskov', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Grit Elster', 'Initials': 'GE', 'LastName': 'Legaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dorph', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Monica Korsager', 'Initials': 'MK', 'LastName': 'Larsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Natja', 'Initials': 'N', 'LastName': 'Launbo', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sabrina Ravn', 'Initials': 'SR', 'LastName': 'Fagerlind', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sidsel Kofoed', 'Initials': 'SK', 'LastName': 'Seide', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Nymand', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ball', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicole Buchner', 'Initials': 'NB', 'LastName': 'Vinum', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Camilla Nørfelt', 'Initials': 'CN', 'LastName': 'Dahl', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Henneberg', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikael Ploug', 'Initials': 'MP', 'LastName': 'Boesen', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Krogh-Madsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jaya Birgitte', 'Initials': 'JB', 'LastName': 'Rosenmeier', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Bispebjerg, Capital Region of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente Klarlund', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2074']
3061,32441458,"Upper-airway collapsibility and compensatory responses under moderate sedation with ketamine, dexmedetomidine, and propofol in healthy volunteers.","BACKGROUND


Ketamine is a potent sedative drug that helps to maintain upper-airway patency, due to its higher upper-airway dilator muscular activity and higher level of duty cycle, as seen in rats. However, no clinical trials have tested passive upper-airway collapsibility and changes in the inspiratory duty cycle against partial upper-airway obstruction in humans. The present study evaluated both the passive mechanical upper-airway collapsibility and compensatory response against acute partial upper-airway obstruction using three different sedative drugs in a crossover trial.
METHODS


Eight male volunteers entered this nonblinded, randomized crossover study. Upper-airway collapsibility (passive critical closing pressure) and inspiratory duty cycle were measured under moderate sedation with ketamine, propofol, and dexmedetomidine. Propofol, dexmedetomidine, and ketamine anesthesia were induced to obtain adequate, same-level sedation, with a BIS value of 50-70 and the OAA/S score of 2-3 and RASS score of -3.
RESULTS


The median passive critical closing pressure of 0.08 [-5.51 to 1.20] cm H 2  O was not significantly different compared to that of propofol sedation (-0.32 [-1.41 to -0.19] cm H 2  O) and of dexmedetomidine sedation (-0.28 [-0.95 to -0.03] cm H 2  O) (p = .045). The median passive R US  for ketamine 54.35 [32.00 to 117.50] cm H 2  O/L/s was significantly higher than that for propofol 5.50 [2.475 to 19.60] cm H 2  O/L/s; (mean difference, 27.50; 95% CI 9.17 to 45.83) (p = .009) and for dexmedetomidine 19.25 [4.125 to 22.05] cm H 2  O/L/s; (mean difference, 22.88; 95% CI 4.67 to 41.09) (p = .021). The inspiratory duty cycle increased significantly as the inspiratory airflow decreased in passive conditions for each sedative drug, but behavior differed among the three sedative drugs.
CONCLUSION


Our findings demonstrate that ketamine sedation may have an advantage of both maintained passive upper-airway collapsibility and a compensatory respiratory response, due to both increase in neuromuscular activity and the increased duty cycle, to acute partial upper-airway obstruction.",2020,O was not significantly different compared to that of propofol sedation (-0.32,"['healthy volunteers', 'Eight male volunteers']","['ketamine', 'Ketamine', 'Propofol, dexmedetomidine, and ketamine anesthesia', 'ketamine, dexmedetomidine, and propofol', 'passive mechanical upper-airway collapsibility and compensatory response against acute partial upper-airway obstruction', 'propofol', 'dexmedetomidine', 'ketamine, propofol, and dexmedetomidine']","['median passive R US', 'Upper-airway collapsibility (passive critical closing pressure) and inspiratory duty cycle', 'inspiratory duty cycle', 'median passive critical closing pressure', 'inspiratory airflow', 'dexmedetomidine sedation', 'neuromuscular activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0740852', 'cui_str': 'Upper airway obstruction'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",8.0,0.0335115,O was not significantly different compared to that of propofol sedation (-0.32,"[{'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Mishima', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Sanuki', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kurata', 'Affiliation': 'Department of Dental Anesthesiology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}]",Physiological reports,['10.14814/phy2.14439']
3062,31446143,"Ticagrelor versus placebo for the reduction of vaso-occlusive crises in pediatric sickle cell disease: Rationale and design of a randomized, double-blind, parallel-group, multicenter phase 3 study (HESTIA3).","BACKGROUND


An unmet need for therapies exists to reduce sickle cell disease (SCD) complications in pediatric patients. Activated platelets contribute to the formation of cellular aggregates during sickling and vaso-occlusive crises (VOCs). Ticagrelor is an oral, direct-acting, and reversible adenosine diphosphate P2Y 12  receptor antagonist that inhibits platelet activation and aggregation. Although ticagrelor was well tolerated in two phase 2 studies in children and young adults with SCD, larger and longer-term treatment studies are needed to assess ticagrelor's efficacy to reduce VOCs. HESTIA3 will evaluate the efficacy, safety, and tolerability of ticagrelor versus placebo over a minimum of 1 year (maximum 2 years) in pediatric patients with SCD.
METHODS


Approximately 180 patients (aged ≥ 2 to <18 years) with SCD (≥ 2 VOCs in the prior year) from 18 countries will be randomized 1:1 to ticagrelor or placebo. Primary endpoint: number of VOCs (a composite endpoint of painful crises and/or acute chest syndrome); key secondary endpoints: hospitalizations, pain intensity and analgesic use during VOCs, acceptability of formulation, and health-related quality of life. The weight-based doses of ticagrelor are set by modeling and simulation. Platelet inhibition data, measured by the vasodilator-stimulated phosphoprotein assay, will be collected for exploratory purposes.
CONCLUSIONS


HESTIA3 aims to demonstrate that using greater target platelet inhibition than previous studies on SCD, ticagrelor will decrease the frequency of VOC in pediatric patients. Trial Identifier: NCT03615924; EudraCT2017-002421-38.",2019,"Ticagrelor is an oral, direct-acting, and reversible adenosine diphosphate P2Y 12  receptor antagonist that inhibits platelet activation and aggregation.","['pediatric patients with SCD.\nMETHODS\n\n\nApproximately 180 patients (aged ≥2 to <18\u202fyears) with SCD (≥2 VOCs in the prior year) from 18 countries', 'pediatric patients', 'pediatric sickle cell disease']","['ticagrelor', 'Ticagrelor', 'placebo', 'ticagrelor or placebo', 'ticagrelor versus placebo']","['number of VOCs (a composite endpoint of painful crises', 'efficacy, safety, and tolerability', 'sickle cell disease (SCD) complications', 'pain intensity and analgesic use during VOCs, acceptability of formulation, and health-related quality of life']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.374828,"Ticagrelor is an oral, direct-acting, and reversible adenosine diphosphate P2Y 12  receptor antagonist that inhibits platelet activation and aggregation.","[{'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Heeney', 'Affiliation': ""Division of Hematology/Oncology, Boston Children's Hospital, Harvard Medical School, 300 Longwood Ave, Boston, MA 02115, USA. Electronic address: matthew.heeney@childrens.harvard.edu.""}, {'ForeName': 'Miguel R', 'Initials': 'MR', 'LastName': 'Abboud', 'Affiliation': 'American University of Beirut Medical Center, Cairo Street, Beirut, Lebanon. Electronic address: ma56@aub.edu.lb.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Amilon', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Pepparedsleden 1, Mölndal 431 83, Sweden. Electronic address: carl.amilon@astrazeneca.com.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Andersson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Pepparedsleden 1, Mölndal 431 83, Sweden. Electronic address: Marielle.Andersson@astrazeneca.com.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Githanga', 'Affiliation': 'Hematology and Blood Transfusion Unit, Department of Human Pathology, University of Nairobi, P. O. Box 19676, Nairobi 00202, Kenya. Electronic address: jessie.githanga@uonbi.ac.ke.'}, {'ForeName': 'Baba', 'Initials': 'B', 'LastName': 'Inusa', 'Affiliation': ""Paediatric Hematology, Guy's and St Thomas' NHS Trust, Evelina London Children's Hospital, Westminster Bridge Rd, Lambeth, London SE1 7EH, UK. Electronic address: Baba.Inusa@gstt.nhs.uk.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kanter', 'Affiliation': 'Hematology-Oncology, Department of Medicine, University of Alabama at Birmingham, 2000 6th Avenue S, Birmingham, AL 35233, USA. Electronic address: kanter@musc.edu.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Leonsson-Zachrisson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Pepparedsleden 1, Mölndal 431 83, Sweden. Electronic address: Maria.Leonsson-Zachrisson@astrazeneca.com.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Michelson', 'Affiliation': ""Center for Platelet Research Studies, Division of Hematology/Oncology, Boston Children's Hospital, Harvard Medical School, 300 Longwood Avenue, Karp 08213, Boston, MA 02115, USA. Electronic address: Alan.Michelson@childrens.harvard.edu.""}, {'ForeName': 'Anders R', 'Initials': 'AR', 'LastName': 'Berggren', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Pepparedsleden 1, Mölndal 431 83, Sweden. Electronic address: anders.r.berggren@astrazeneca.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2019.105835']
3063,30833118,Changes in Health-Related Outcomes in Youth With Obesity in Response to a Home-Based Parent-Led Physical Activity Program.,"PURPOSE


The purpose of this study was to elucidate whether implementation of a parent-led physical activity (PA) curriculum improved health parameters in youth with obesity.
METHODS


This prospective study included 45 youth with Prader-Willi syndrome (PWS) and 66 youth classified as obese without PWS. Participants were quasi-randomly assigned to an intervention (I) group which completed PA sessions (25-45+ minutes long) 4 days/week for 24 weeks or to a control (C) group. Generalized estimating equations analyzed differences in body composition, PA, and health-related quality of life (HRQL) by youth group, time, and treatment group. A secondary analysis in the I-group compared outcomes based on whether youth showed increases (n = 12) or decreases (n = 19) of ≥2 minutes of moderate-to-vigorous PA (MVPA).
RESULTS


Body mass index increased from baseline to 24 weeks in youth with obesity (p = .032) but not in youth with PWS. There were no changes in MVPA, total PA, or body fat indicators over time. The I-group demonstrated an increase of 7.2% and 7.6% in social and school HRQL, respectively, and a 3.3% improvement in total HRQL. Youth in the I-group who increased MVPA demonstrated decreased body mass (p = .010), body mass index z-score (p = .018), and body fat mass (p = .011); these changes were not observed in those who decreased MVPA over time.
CONCLUSIONS


Participation in a parent-led PA intervention at home can positively influence HRQL in youth with obesity and/or PWS. Increases in MVPA ≥2 minutes above baseline led to decreases in body mass and fat, while maintaining lean mass.",2019,"Youth in the I-group who increased MVPA demonstrated decreased body mass (p = .010), body mass index z-score (p = .018), and body fat mass (p = .011); these changes were not observed in those who decreased MVPA over time.
","['youth with obesity', '45 youth with Prader-Willi syndrome (PWS) and 66\xa0youth classified as obese without PWS', 'youth with obesity and/or PWS']","['parent-led physical activity (PA) curriculum', 'intervention (I) group which completed PA sessions']","['Body mass index', 'body fat mass', 'body mass index z-score', 'MVPA, total PA, or body fat indicators', 'body mass', 'total HRQL', 'body composition, PA, and health-related quality of life (HRQL']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032897', 'cui_str': 'Labhart-Willi-Prader-Fanconi Syndrome'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",45.0,0.0453122,"Youth in the I-group who increased MVPA demonstrated decreased body mass (p = .010), body mass index z-score (p = .018), and body fat mass (p = .011); these changes were not observed in those who decreased MVPA over time.
","[{'ForeName': 'Daniela A', 'Initials': 'DA', 'LastName': 'Rubin', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, Fullerton, California. Electronic address: drubin@fullerton.edu.'}, {'ForeName': 'Kathleen S', 'Initials': 'KS', 'LastName': 'Wilson', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, Fullerton, California.'}, {'ForeName': 'Diobel M', 'Initials': 'DM', 'LastName': 'Castner', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, Fullerton, California.'}, {'ForeName': 'Marilyn C', 'Initials': 'MC', 'LastName': 'Dumont-Driscoll', 'Affiliation': 'Department of Pediatrics, College of Medicine, University of Florida, Gainesville, Florida.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2018.11.014']
3064,31126775,"Resurfacing in a Posterior-Stabilized Total Knee Arthroplasty Reduces Patellar Crepitus Complication: A Randomized, Controlled Trial.","BACKGROUND


Patellar crepitus (PC) is a common complication after total knee arthroplasty (TKA) using a posterior-stabilized (PS) prosthesis. While numerous factors have been associated with PC development after PS-TKA, patellar resurfacing (PR) which directly impacts the patellofemoral joint kinematics has been underinvestigated. A prospective, randomized, controlled trial was conducted to (1) compare the PC incidence in PR and non-PR PS-TKA, (2) determine the time of PC presentation in PS-TKA, (3) identify radiographic parameters associated with PC, and (4) compare clinical outcomes of patients with and without PR.
METHODS


A total of 84 patients who underwent unilateral TKA using the Legion PS Total Knee System were randomized into PR group or non-PR group. PC incidence, time of PC presentation, radiographic parameters associated with PC development, and clinical outcomes were evaluated at 3 months, 6 months, 9 months, and 1 year postoperatively.
RESULTS


PC occurred significantly more in the non-PR group (23.1% vs 7.3%, P = .048). Time of PC presentation in both groups was not different. Anterior knee pain was found in 16.7% of crepitus patients, and none required any surgical procedure. The non-PR knees had significant decreases in patellar shift index, patellar displacement, Insall-Salvati ratio, and patellar component height and increase in change in posterior femoral offset. Oxford and patellar scores were significantly better in the PR group at 9 months and 1 year.
CONCLUSION


Given higher PC incidence and several worse clinical outcomes in the non-PR, we recommend resurfacing during PS-TKA with this knee system to avoid PC development.",2019,"The non-PR knees had significant decreases in patellar shift index, patellar displacement, Insall-Salvati ratio, and patellar component height and increase in change in posterior femoral offset.","['patients with and without PR', '84 patients who underwent unilateral TKA using the Legion PS Total Knee System']","['Posterior-Stabilized Total Knee Arthroplasty', 'Resurfacing', 'PR group or non-PR', 'Patellar crepitus (PC', 'posterior-stabilized (PS) prosthesis']","['Oxford and patellar scores', 'Anterior knee pain', 'Time of PC presentation', 'patellar shift index, patellar displacement, Insall-Salvati ratio, and patellar component height and increase in change in posterior femoral offset', 'Patellar Crepitus Complication', 'PC incidence, time of PC presentation, radiographic parameters associated with PC development, and clinical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",84.0,0.0651546,"The non-PR knees had significant decreases in patellar shift index, patellar displacement, Insall-Salvati ratio, and patellar component height and increase in change in posterior femoral offset.","[{'ForeName': 'Satit', 'Initials': 'S', 'LastName': 'Thiengwittayaporn', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Dusit, Bangkok, Thailand.'}, {'ForeName': 'Kakanand', 'Initials': 'K', 'LastName': 'Srungboonmee', 'Affiliation': 'Center of Data Mining and Biomedical Informatics, Faculty of Medical Technology, Mahidol University, Salaya, Nakornpathom, Thailand.'}, {'ForeName': 'Bhakawat', 'Initials': 'B', 'LastName': 'Chiamtrakool', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Dusit, Bangkok, Thailand.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.04.050']
3065,31155474,Dietary Self-Monitoring Through Calorie Tracking but Not Through a Digital Photography App Is Associated with Significant Weight Loss: The 2SMART Pilot Study-A 6-Month Randomized Trial.,"BACKGROUND


Dietary self-monitoring (DSM) of foods and beverages is associated with weight loss in behavioral interventions; however, DSM may be burdensome, and adherence may decrease over time. Novel methods of DSM, including apps that track food using photographs, may decrease burden, increase DSM adherence, and improve weight loss.
OBJECTIVE


The objective was to test a mobile photo DSM app compared to a calorie-tracking DSM app on tracking frequency and weight loss in a remotely delivered behavioral weight-loss intervention.
DESIGN


This was a 6-month (October 2016 to April 2017) randomized trial.
PARTICIPANTS/SETTING


Participants were adults (n=41) classified as overweight or obese (body mass index 25 to 49.9) from South Carolina.
INTERVENTION


Participants received remotely delivered twice-weekly behavioral weight-loss podcasts and tracked diet using a calorie-tracking DSM app (Calorie Group) or a photo DSM app (Photo Group).
MAIN OUTCOME MEASURES


Main outcomes were the number of days diet was tracked, podcasts downloaded, and weight change at 6 weeks and 6 months.
STATISTICAL ANALYSES


Researchers used nonparametric Wilcoxon rank sum tests and χ 2  analysis to test for differences between groups at baseline; repeated-measures models to estimate weight change and Spearman correlations to determine relationships between DSM frequency, podcasts downloaded, and weight change at 6 months.
RESULTS


There were no differences between groups for the number of days that diet was recorded (P=0.18), which was low overall (<30% of days) but was statistically significantly and strongly correlated with weight change for all participants pooled (r=0.63; P<0.001) and for the calorie tracking group (r=0.70; P=0.004), but not the photo tracking group (r=0.51; P=0.06). Participants in both groups had significant weight loss at 6 months (Photo Group, -2.5±0.9 kg; P=0.008; Calorie Group -2.4±0.9 kg; P=0.007), with no differences between groups at either 6 weeks (P=0.66) or at 6 months (P=0.74).
CONCLUSIONS


As part of a remotely delivered weight loss intervention, frequency of DSM was significantly associated with overall weight loss for participants using a calorie DSM app but not a photo DSM app. DSM was low regardless of group and weight loss was significant, although minimal. Increasing user engagement with any DSM may be important to increase self-monitoring and improve weight loss.",2019,"Participants in both groups had significant weight loss at 6 months (Photo Group, -2.5±0.9 kg; P=0.008; Calorie Group -2.4±0.9 kg; P=0.007), with no differences between groups at either 6 weeks (P=0.66) or at 6 months (P=0.74).
",['Participants were adults (n=41) classified as overweight or obese (body mass index 25 to 49.9) from South Carolina'],"['Participants received remotely delivered twice-weekly behavioral weight-loss podcasts and tracked diet using a calorie-tracking DSM app (Calorie Group) or a photo DSM app (Photo Group', 'calorie-tracking DSM']","['number of days diet was tracked, podcasts downloaded, and weight change', 'weight loss', 'DSM adherence', 'Weight Loss', 'overall weight loss', 'weight change', 'number of days that diet']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}]","[{'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2718063', 'cui_str': 'Podcasts'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C2718063', 'cui_str': 'Podcasts'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0313166,"Participants in both groups had significant weight loss at 6 months (Photo Group, -2.5±0.9 kg; P=0.008; Calorie Group -2.4±0.9 kg; P=0.007), with no differences between groups at either 6 weeks (P=0.66) or at 6 months (P=0.74).
","[{'ForeName': 'Caroline Glagola', 'Initials': 'CG', 'LastName': 'Dunn', 'Affiliation': ''}, {'ForeName': 'Gabrielle M', 'Initials': 'GM', 'LastName': 'Turner-McGrievy', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hutto', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.03.013']
3066,32441471,Effect of Plain Versus Sugar-Sweetened Breakfast on Energy Balance and Metabolic Health: A Randomized Crossover Trial.,,2020,,[],['Plain Versus Sugar-Sweetened Breakfast'],['Energy Balance and Metabolic Health'],[],"[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.070632,,[],"Obesity (Silver Spring, Md.)",['10.1002/oby.22847']
3067,31447129,"Efficacy and Safety of an Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination After Bunionectomy: a Randomized, Double-blind, Factorial, Placebo-controlled Trial.","PURPOSE


Multimodal analgesia with acetaminophen and/or nonsteroidal anti-inflammatory drugs is recommended for the treatment of postoperative pain. Although oral fixed-dose combinations (FDCs) are available, parenteral administration may be clinically justified. The goal of this study was to investigate the clinical efficacy and safety of an intravenous FDC of ibuprofen and acetaminophen after bunionectomy.
METHODS


This study was a prospective, randomized, double-blind, multicenter, placebo-controlled factorial clinical trial conducted at 2 clinical research centers in the United States between November 2016 and June 2017. Eligible patients (male and female subjects, aged 18-65 years, reporting pain intensity levels ≥40 mm on a 100-mm visual analog scale (VAS) after distal, first metatarsal bunionectomy) were randomized (3:3:3:2) to receive the FDC (ibuprofen 300 mg + acetaminophen 1000 mg), ibuprofen 300 mg, acetaminophen 1000 mg, or placebo (vehicle), administered as 15-minute intravenous infusions every 6 hours for 48 hours. The primary efficacy end point was the time-adjusted sum of pain intensity differences from baseline over 48 hours (SPID 48 ). In addition to VAS pain intensity scores, pain relief scores, time to perceptible and meaningful pain relief, the use of rescue medication, and participant's global evaluations of the study drug were recorded. Adverse events occurring during the 48-hour treatment period were included in the safety analysis.
FINDINGS


A total of 276 participants were enrolled; most were female (82%), the mean age was 42.4 years, and the median baseline VAS was 67 mm, indicating moderate to severe pain. SPID 48  was significantly higher for the FDC (23.4 [2.5] mm) than for ibuprofen (9.5 [2.5] mm), acetaminophen (10.4 [2.5] mm), and placebo (-1.3 [3.1] mm; all, P < 0.001). The superior analgesic effect of the FDC was supported by a range of secondary end points, including reduced opioid usage rates (75% for FDC, 92% for ibuprofen, 93% for acetaminophen, and 96% for placebo; all, P < 0.005). The safety profile of the FDC was comparable to that of intravenous ibuprofen or acetaminophen alone. Three participants withdrew from the study due to adverse events: 2 in the ibuprofen group and 1 in the acetaminophen group.
IMPLICATIONS


The study found that repeated administration of an intravenous FDC of ibuprofen and acetaminophen provided statistically significant improvement in SPID 48  over comparable doses of either monotherapy without an increase in adverse events. ClinicalTrials.gov identifier: NCT02689063.",2019,"The superior analgesic effect of the FDC was supported by a range of secondary end points, including reduced opioid usage rates (75% for FDC, 92% for ibuprofen, 93% for acetaminophen, and 96% for placebo; all, P < 0.005).","['Eligible patients (male and female subjects, aged 18-65 years, reporting pain intensity levels ≥40\xa0mm on a 100-mm visual analog scale (VAS) after distal, first metatarsal bunionectomy', 'A total of 276 participants were enrolled; most were female (82%), the mean age was 42.4 years, and the median baseline VAS was 67\xa0mm, indicating moderate to severe pain', '2 clinical research centers in the United States between November 2016 and June 2017']","['acetaminophen', 'placebo', 'ibuprofen 300\xa0mg, acetaminophen 1000\xa0mg, or placebo (vehicle', 'FDC (ibuprofen 300\xa0mg\xa0+\xa0acetaminophen', 'Acetaminophen/Ibuprofen Fixed-dose Combination', 'monotherapy', 'ibuprofen', 'Placebo', 'ibuprofen and acetaminophen']","[""VAS pain intensity scores, pain relief scores, time to perceptible and meaningful pain relief, the use of rescue medication, and participant's global evaluations"", 'reduced opioid usage rates', 'adverse events', 'Adverse events', 'time-adjusted sum of pain intensity differences', 'SPID 48', 'Efficacy and Safety', 'clinical efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0025584', 'cui_str': 'Metatarsals'}, {'cui': 'C1542057', 'cui_str': 'Silver bunionectomy (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0986665', 'cui_str': 'Ibuprofen 300 MG'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C2047874', 'cui_str': 'Acetaminophen / Ibuprofen'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}]",276.0,0.696606,"The superior analgesic effect of the FDC was supported by a range of secondary end points, including reduced opioid usage rates (75% for FDC, 92% for ibuprofen, 93% for acetaminophen, and 96% for placebo; all, P < 0.005).","[{'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Daniels', 'Affiliation': 'Optimal Research LLC, Austin, TX, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Playne', 'Affiliation': 'AFT Pharmaceuticals Ltd, Auckland, New Zealand.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Stanescu', 'Affiliation': 'AFT Pharmaceuticals Ltd, Auckland, New Zealand. Electronic address: ioana@aftpharm.com.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'AFT Pharmaceuticals Ltd, Auckland, New Zealand.'}, {'ForeName': 'Ira J', 'Initials': 'IJ', 'LastName': 'Gottlieb', 'Affiliation': 'Chesapeake Research Group, Pasadena, MD, USA.'}, {'ForeName': 'Hartley C', 'Initials': 'HC', 'LastName': 'Atkinson', 'Affiliation': 'AFT Pharmaceuticals Ltd, Auckland, New Zealand.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.07.008']
3068,31447130,Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study.,"PURPOSE


The goal of this study was to assess the long-term safety and efficacy of mepolizumab in patients with the most severe eosinophilic asthma.
METHODS


This multicenter, open-label, long-term, Phase IIIb study (COSMEX [COSMOS Extension]; 201312/NCT02135692) enrolled patients from the 52-week, open-label extension study COSMOS (A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects) that previously enrolled patients from the double-blinded, placebo-controlled Phase III studies MENSA (Mepolizumab as Adjunctive Therapy in Patients with Severe Asthma) and SIRIUS (Steroid Reduction with Mepolizumab Study). To enter COSMEX, patients had to have life-threatening/seriously debilitating asthma before entering MENSA or SIRIUS and to have completed these previous studies with demonstrated improvement while receiving mepolizumab. In COSMEX, patients received mepolizumab 100 mg subcutaneously every 4 weeks as add-on therapy for up to 172 weeks. Primary endpoints were adverse event frequency and exacerbation rate per year; also assessed were forced expiratory volume in 1 s, Asthma Control Questionnaire-5 score, and daily oral corticosteroid (OCS) use.
FINDINGS


Of the 340 patients enrolled, 339 received mepolizumab; median treatment duration within this extension study was 2.2 years, equating to 718 patient-years of additional exposure. No new safety signals were identified. Patients receiving mepolizumab throughout this study and previous studies had lasting reductions in exacerbation rate and daily OCS use and improvements in forced expiratory volume in 1 s and Asthma Control Questionnaire-5 score. In COSMEX, the on-treatment exacerbation rate (95% CI) was 0.93 (0.81-1.06) event/year for clinically significant exacerbations, 0.13 (0.10-0.18) event/year for exacerbations requiring hospitalization/emergency department visit, and 0.07 (0.05-0.10) event/year for exacerbations requiring hospitalization. In patients requiring systemic/oral corticosteroids with ≥128 weeks of continuous enrollment across SIRIUS, COSMOS, and COSMEX, mepolizumab maintained the median daily OCS dose at 1.3-2.8 mg during COSMEX, with additional patients no longer requiring OCS after extended mepolizumab treatment.
IMPLICATIONS


This study indicates that long-term mepolizumab treatment is well tolerated and associated with sustained clinical benefits in patients with severe eosinophilic asthma. ClinicalTrials.gov identifier: NCT02135692.",2019,Patients receiving mepolizumab throughout this study and previous studies had lasting reductions in exacerbation rate and daily OCS use and improvements in forced expiratory volume in 1 s and Asthma Control Questionnaire-5 score.,"['patients with the most severe eosinophilic asthma', 'Patients', 'patients with severe eosinophilic asthma', 'in Patients with Severe Asthma) and SIRIUS (Steroid Reduction with Mepolizumab Study', '340 patients enrolled']","['Mepolizumab', 'mepolizumab', 'placebo-controlled Phase III studies MENSA (Mepolizumab as Adjunctive Therapy']","['adverse event frequency and exacerbation rate per year; also assessed were forced expiratory volume in 1\xa0s, Asthma Control Questionnaire-5 score, and daily oral corticosteroid (OCS) use', 'exacerbation rate and daily OCS use and improvements in forced expiratory volume in 1\xa0s and Asthma Control Questionnaire-5 score', 'treatment exacerbation rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0034068', 'cui_str': 'Pulmonary Eosinophilia'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517730', 'cui_str': '340'}]","[{'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",340.0,0.180543,Patients receiving mepolizumab throughout this study and previous studies had lasting reductions in exacerbation rate and daily OCS use and improvements in forced expiratory volume in 1 s and Asthma Control Questionnaire-5 score.,"[{'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Khurana', 'Affiliation': 'Department of Medicine/Pulmonary, University of Rochester School of Medicine & Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Guy G', 'Initials': 'GG', 'LastName': 'Brusselle', 'Affiliation': 'Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Elisabeth H', 'Initials': 'EH', 'LastName': 'Bel', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'FitzGerald', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Masoli', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals Plymouth NHS Trust, Plymouth, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Korn', 'Affiliation': 'Pulmonary Department, Universitätsmedizin Mainz, Mainz, Germany.'}, {'ForeName': 'Motokazu', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Chest Disease Clinical and Research Institute, Kishiwada City Hospital, Osaka, Japan.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Albers', 'Affiliation': 'Respiratory Medical Franchise, GlaxoSmithKline, Research Triangle Park, NC, USA. Electronic address: frank-c.albers@t-online.de.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Bradford', 'Affiliation': 'Respiratory Therapeutic Area, GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Martyn J', 'Initials': 'MJ', 'LastName': 'Gilson', 'Affiliation': 'Respiratory Research and Development, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Price', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Humbert', 'Affiliation': 'Assistance Publique -Hôpitaux de Paris, Service de Pneumologie, Hôpital Bicêtre, Paris, France; Univ. Paris-Sud, Université Paris-Saclay, Paris, France; INSERM U999, Le Kremlin-Bicêtre, Paris, France.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.07.007']
3069,32441407,The influence of titanium base abutments on peri-implant soft tissue inflammatory parameters and marginal bone loss: A randomized clinical trial.,"BACKGROUND


Some techniques in implant dentistry have been suggested that may potentially alter peri-implant soft and hard tissue parameters.
PURPOSE


To evaluate the peri-implant soft tissue inflammatory parameters and crestal bone loss around titanium base abutments.
MATERIALS AND METHODS


Fifty two implants were placed in 21 patients and restored by single crowns. Subjects were randomly allocated into two groups: cement-retained abutment (n = 24) and titanium base (n = 28). Peri-implant probing depth, and mesial and distal marginal bone loss (MBL) were evaluated at implant loading (T1), 6 and 12 months (T2 and T3, respectively). Peri-implant bleeding-on-probing was evaluated at T2 and T3. Two-way repeated measures analysis of variance, Tukey test, Man Whitney, and Pearson correlation were performed for statistical analysis at P < .05.
RESULTS


The mean difference of peri-implant MBL from implant installation to 12 months in function was 1.15 ± 0.82 mm for the cement-retained group, and 1.23 ± 0.79 mm for the titanium base group. No statistically significant difference was found between the two groups for clinical and radiographic peri-implant evaluation.
CONCLUSIONS


Titanium base abutments present no negative effect on peri-implant soft tissue and MBL. When used to support single crowns, both approaches performed likewise regarding clinical and radiographic parameters.",2020,"No statistically significant difference was found between the two groups for clinical and radiographic peri-implant evaluation.
",['Fifty two implants were placed in 21 patients and restored by single crowns'],"['cement-retained abutment', 'titanium base abutments']","['marginal bone loss', 'Peri-implant probing depth, and mesial and distal marginal bone loss (MBL', 'Peri-implant bleeding-on-probing', 'variance, Tukey test, Man Whitney, and Pearson correlation']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0010384', 'cui_str': 'Crown'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",52.0,0.0639248,"No statistically significant difference was found between the two groups for clinical and radiographic peri-implant evaluation.
","[{'ForeName': 'Saulo', 'Initials': 'S', 'LastName': 'Pamato', 'Affiliation': 'Post-Graduate Program of Health Sciences, University of Southern Santa Catarina, Tubarão, Santa Catarina, Brazil.'}, {'ForeName': 'Heitor Marques', 'Initials': 'HM', 'LastName': 'Honório', 'Affiliation': 'Department of Pediatrics Dentistry, Orthodontics, and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru Campus, São Paulo, Brazil.'}, {'ForeName': 'Jorge Alexandre', 'Initials': 'JA', 'LastName': 'da Costa', 'Affiliation': 'Department of Prosthodontics, University of Southern Santa Catarina, Tubarão, Santa Catarina, Brazil.'}, {'ForeName': 'Jefferson Luiz', 'Initials': 'JL', 'LastName': 'Traebert', 'Affiliation': 'Post-Graduate Program of Health Sciences, University of Southern Santa Catarina, Tubarão, Santa Catarina, Brazil.'}, {'ForeName': 'Estevam Augusto', 'Initials': 'EA', 'LastName': 'Bonfante', 'Affiliation': 'Department of Prosthodontics and Periodontology, Bauru School of Dentistry, University of São Paulo, Bauru Campus, São Paulo, Brazil.'}, {'ForeName': 'Jefferson Ricardo', 'Initials': 'JR', 'LastName': 'Pereira', 'Affiliation': 'Post-Graduate Program of Health Sciences, University of Southern Santa Catarina, Tubarão, Santa Catarina, Brazil.'}]",Clinical implant dentistry and related research,['10.1111/cid.12900']
3070,31382205,A flexible framework for planning and evaluating early-stage health interventions: FRAME-IT.,"Health interventions exhibit three stages of maturity: early-, mid-, and late-stages. Early-stage interventions have innovative content necessitating evaluation; however existing evaluation frameworks omit constructs and guidelines relevant to this evaluation. Early-stage interventions require planning and evaluation that supports creating, testing, and exploring content to establish general feasibility and enable refinement for further testing, prior to randomised controlled trialling and wider dissemination. Feasibility, Reach-out, Acceptability, Maintenance, Efficacy, Implementation, Tailorability (FRAME-IT) was developed for a mixed methods feasibility study of a novel well-being intervention. FRAME-IT was conceived as a complementary framework to Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM; Glasgow et al., 1999) which is better suited for mid- and late- stage interventions. FRAME-IT is proposed to support: (1) early-stage intervention planning and design, by guiding research focus and data sourcing strategy with relevant constructs; (2) comprehensive evaluation, by including constructs appropriate for early-stage interventions, i.e. feasibility, acceptability, and tailorability; (3) future intervention scalability, by including and adapting some of RE-AIM's constructs to encourage a smoother translation of research into practice as interventions are scaled-up.",2019,Health interventions exhibit three stages of maturity:,['maturity'],[],"['Feasibility, Reach-out, Acceptability, Maintenance, Efficacy, Implementation, Tailorability (FRAME-IT']","[{'cui': 'C0449989', 'cui_str': 'Maturity (attribute)'}]",[],"[{'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}]",,0.0352881,Health interventions exhibit three stages of maturity:,"[{'ForeName': 'Freda N', 'Initials': 'FN', 'LastName': 'Gonot-Schoupinsky', 'Affiliation': 'University of Derby Online Learning, University of Derby, Enterprise Centre, Bridge Street, Derby DE1 3LD, United Kingdom. Electronic address: Laughie.Research@gmail.com.'}, {'ForeName': 'Gulcan', 'Initials': 'G', 'LastName': 'Garip', 'Affiliation': 'University of Derby Online Learning, University of Derby, Enterprise Centre, Bridge Street, Derby DE1 3LD, United Kingdom. Electronic address: G.Garip@derby.ac.uk.'}]",Evaluation and program planning,['10.1016/j.evalprogplan.2019.101685']
3071,31400765,Effects of isomaltulose ingestion on postexercise hydration state and heat loss responses in young men.,"NEW FINDINGS


What is the central question of this study? What are the effects of isomaltulose, an ingredient in carbohydrate-electrolyte beverages to maintain glycaemia and attenuate the risk of dehydration during exercise heat stress, on postexercise rehydration and physiological heat loss responses? What is the main finding and its importance? Consumption of a 6.5% isomaltulose-electrolyte beverage following exercise heat stress restored hydration following a 2 h recovery as compared to a 2% solution or water only. While the 6.5% isomaltulose-electrolytes increased plasma volume and plasma osmolality, which are known to modulate postexercise heat loss, sweating and cutaneous vascular responses did not differ between conditions. Consequently, ingestion beverages containing 6.5% isomaltulose-electrolytes enhanced postexercise rehydration without affecting heat loss responses.
ABSTRACT


Isomaltulose is a disaccharide carbohydrate widely used during exercise to maintain glycaemia and hydration. We investigated the effects of ingesting a beverage containing isomaltulose and electrolytes on postexercise hydration state and physiological heat loss responses. In a randomized, single-blind cross-over design, 10 young healthy men were hypohydrated by performing up to three 30 min successive moderate-intensity (50% heart rate reserve) bouts of cycling, each separated by 10 min, while wearing a water-perfusion suit heated to 45°C. The protocol continued until a 2% reduction in body mass was achieved. Thereafter, participants performed a final 15 min moderate-intensity exercise bout followed by a 2 h recovery. Following cessation of exercise, participants ingested a beverage consisting of (i) water only (Water), (ii) 2% isomaltulose (CHO-2%), or (iii) 6.5% isomaltulose (CHO-6.5%) equal to the volume of 2% body mass loss within the first 30 min of the recovery. Changes in plasma volume (ΔPV) after fluid ingestion were greater for CHO-6.5% compared with CHO-2% (120 min postexercise) and Water (90 and 120 min) (all P ≤ 0.040). Plasma osmolality remained elevated with CHO-6.5% compared with consumption of the other beverages at 30 and 90 min postexercise (all P ≤ 0.050). Urine output tended to be reduced with CHO-6.5% compared to other fluid conditions (main effect, P = 0.069). Rectal and mean skin temperatures, chest sweat rate and cutaneous perfusion did not differ between conditions (all P > 0.05). In conclusion, compared with CHO-2% and Water, consuming a beverage consisting of CHO-6.5% and electrolytes during recovery under heat stress enhances PV recovery without modulating physiological heat loss responses.",2019,"Rectal and mean skin temperatures, chest sweat rate and cutaneous perfusion did not differ between conditions (all P > 0.05).","['young men', '10 young healthy men']","['ingesting a beverage containing isomaltulose and electrolytes', 'isomaltulose ingestion', 'hypohydrated by performing up to three 30\xa0min successive moderate-intensity (50% heart rate reserve) bouts of cycling, each separated by 10\xa0min, while wearing a water-perfusion suit heated to 45°C']","['Rectal and mean skin temperatures, chest sweat rate and cutaneous perfusion', 'Urine output', 'body mass', 'plasma volume and plasma osmolality', 'postexercise hydration state and heat loss responses', 'Plasma osmolality', 'plasma volume (ΔPV) after fluid ingestion', 'postexercise heat loss, sweating and cutaneous vascular responses']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0064002', 'cui_str': 'isomaltulose anhydrous'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0018837', 'cui_str': 'Heat'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0038990', 'cui_str': 'Sweating'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0032127', 'cui_str': 'Blood Plasma Volume'}, {'cui': 'C0860721', 'cui_str': 'Plasma osmolality (observable entity)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018840', 'cui_str': 'Heat Loss'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",,0.0367423,"Rectal and mean skin temperatures, chest sweat rate and cutaneous perfusion did not differ between conditions (all P > 0.05).","[{'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Amano', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Sugiyama', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Okumura', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Fujii', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Japan.'}, {'ForeName': 'Glen P', 'Initials': 'GP', 'LastName': 'Kenny', 'Affiliation': 'Human and Environmental Physiology Research Unit, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nishiyasu', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Japan.'}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Laboratory for Human Performance Research, Osaka International University, Osaka, Japan.'}, {'ForeName': 'Narihiko', 'Initials': 'N', 'LastName': 'Kondo', 'Affiliation': 'Laboratory for Applied Human Physiology, Graduate School of Human Development and Environment, Kobe University, Kobe, Japan.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Sasagawa', 'Affiliation': 'Bourbon Institutes of Health Nutraceuticals Science Laboratory, Bourbon Corporation, Niigata, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Enoki', 'Affiliation': 'Bourbon Institutes of Health Nutraceuticals Science Laboratory, Bourbon Corporation, Niigata, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Maejima', 'Affiliation': 'Bourbon Institutes of Health Nutraceuticals Science Laboratory, Bourbon Corporation, Niigata, Japan.'}]",Experimental physiology,['10.1113/EP087843']
3072,31414914,Pre-diagnostic body mass index trajectory in relationship to lung cancer incidence and mortality; findings from the PLCO trial.,"Objectives : The current study aims to evaluate the correlation between pre-diagnostic body mass index (BMI) as well as BMI trajectory in relation to lung cancer development and mortality risks.  Methods : This analysis is based on Prostate, Lung, Colorectal, and Ovary (PLCO) trial datasets. Based on 145544 participants with complete information about pre-diagnostic BMI/BMI trajectory, associations of BMI measurements during adult life (at 20 years, 50 years and at enrolment into the study) with lung cancer development and mortality risks were determined. Multivariate Cox regression models were used to determine hazard ratios (HRs) of lung cancer development and mortality risks.  Results : Higher BMI at 20 years, 50 years as well as the time of enrolment was associated with lower probability of lung cancer development (P = 0.004; P < 0.001; P < 0.001; respectively). Among different BMI trajectories, lung cancer risk was decreased among patients who had normal BMI at age 20 then became overweight (P < 0.001) or obese (P < 0.001) at the age of 50 compared to patients who maintained normal BMI. Likewise, death from lung cancer was reduced among patients with higher BMI at 20 years, 50 years as well as at the time of enrolment (P = 0.027; P < 0.001; P < 0.001). Additionally, death from lung cancer was reduced among patients who had normal BMI at age 20 then became overweight (P < 0.001) or obese (P < 0.001) at the age of 50 compared to patients who maintained normal BMI.  Conclusions : Overall, higher pre-diagnostic BMI seems to be associated with lower probability of lung cancer development and death. Moreover, an escalating temporal trajectory of pre-diagnostic BMI seems to be associated with a lower risk of the development of and death from lung cancer.",2019,"Additionally, death from lung cancer was reduced among patients who had normal BMI at age 20 then became overweight (P < 0.001) or obese (P < 0.001) at the age of 50 compared to patients who maintained normal BMI.  ","['145544 participants with complete information about pre-diagnostic BMI/BMI trajectory, associations of BMI measurements during adult life (at 20 years, 50 years and at enrolment into the study) with lung cancer development and']",[],"['Higher BMI', 'lung cancer risk', 'hazard ratios (HRs) of lung cancer development and mortality risks', 'probability of lung cancer development and death', 'death from lung cancer', 'Likewise, death from lung cancer', 'probability of lung cancer development', 'mortality risks']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0243107', 'cui_str': 'development'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0407179,"Additionally, death from lung cancer was reduced among patients who had normal BMI at age 20 then became overweight (P < 0.001) or obese (P < 0.001) at the age of 50 compared to patients who maintained normal BMI.  ","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Abdel-Rahman', 'Affiliation': 'Clinical Oncology Department, Faculty of Medicine, Ain Shams University , Cairo , Egypt.'}]",Expert review of respiratory medicine,['10.1080/17476348.2019.1656532']
3073,32441473,Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5.,"OBJECTIVE


The obesity epidemic is a public health concern, warranting further research into pharmacological treatments for weight management (WM) as an adjunct to lifestyle interventions. The Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with obesity or overweight.
METHODS


Across five phase 3 trials (NCT03548935, WM; NCT03552757, WM in type 2 diabetes; NCT03611582, WM with intensive behavioral therapy; NCT03548987, sustained WM; and NCT03693430, long-term WM), ~5,000 participants are being randomly assigned to receive semaglutide 2.4 mg once weekly subcutaneously versus placebo. Results will be available in 2020/2021. For all trials, the primary end point is change from baseline to end of treatment in body weight.
RESULTS


Participants have a mean age of 46.2 to 55.3 years, are mostly female (mean: 74.1%-81.0%), and have a mean BMI of 35.7 to 38.5 kg/m 2  and a mean waist circumference of 113.0 to 115.7 cm.
CONCLUSIONS


The STEP program evaluates the efficacy and safety of semaglutide 2.4 mg subcutaneously once weekly in a broad population. The trials will provide insights on WM in people with obesity with and without type 2 diabetes and on long-term follow-up.",2020,"The Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with obesity or overweight.
","['Participants have a mean age of 46.2 to 55.3 years, are mostly female (mean: 74.1%-81.0%), and have a mean BMI of 35.7 to 38.5 kg/m 2  and a mean waist circumference of 113.0 to 115.7 cm', '5,000 participants', 'people with obesity with and without type 2 diabetes and on long-term follow-up', 'adults with obesity or overweight', 'People with obesity (STEP) program']","['semaglutide 2.4 mg once weekly subcutaneously versus placebo', 'semaglutide versus placebo']","['body weight', 'efficacy and safety', 'weight loss, safety, and tolerability']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0600766,"The Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with obesity or overweight.
","[{'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Kushner', 'Affiliation': 'Division of Endocrinology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Calanna', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Dicker', 'Affiliation': 'Department of Internal Medicine, Hasharon Hospital Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'W Timothy', 'Initials': 'WT', 'LastName': 'Garvey', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Goldman', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine/Endocrinology, UT Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Thomsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Wharton', 'Affiliation': 'York University and Wharton Weight Management Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Obesity and Endocrinology Research, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': 'Washington Center for Weight Management and Research, Arlington, Virginia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22794']
3074,32441474,Impact of Combined Hormonal Contraceptive Use on Weight Loss: A Secondary Analysis of a Behavioral Weight-Loss Trial.,"OBJECTIVE


This study aimed to perform a preliminary investigation of the impact of combined hormonal contraceptive (CHC) use on weight loss during an 18-month behavioral weight-loss trial.
METHODS


Adults (n = 170; 18-55 years; BMI 27-42 kg/m 2  ) received a weight-loss intervention that included a reduced-calorie diet, a progressive exercise prescription, and group-based behavioral support. Premenopausal women (n = 110) were classified as CHC users (CHC, n = 17) or non-CHC users (non-CHC, n = 93). Changes in weight were examined within groups using a linear mixed model, adjusted for age and randomized group assignment.
RESULTS


At 6 M, weight was reduced from baseline in both CHC (mean, -6.7 kg; 95% CI: -9.8 to -3.7 kg) and non-CHC (-9.1 kg; -9.1 to -6.4 kg). Between 6 and 18 M, CHC regained weight (4.9 kg; 0.9 to 8.9 kg), while weight remained relatively unchanged in non-CHC (-0.1 kg; -1.8 to 1.6 kg). At 18 M, weight was relatively unchanged from baseline in CHC (-1.8 kg; -7.3 to 3.6 kg) and was reduced from baseline in non-CHC (-7.9 kg; -10.2 to -5.5 kg).
CONCLUSIONS


In this secondary data analysis, CHC use was associated with weight regain after initial weight loss. Prospective studies are needed to further understand the extent to which CHC use influences weight loss and maintenance.",2020,"At 6 M, weight was reduced from baseline in both CHC (mean, -6.7 kg; 95% CI: -9.8 to -3.7 kg) and non-CHC (-9.1 kg; -9.1 to -6.4 kg).","['Adults (n\u2009=\u2009170; 18-55 years; BMI 27-42 kg/m 2  ', 'Premenopausal women (n\u2009=\u2009110) were classified as CHC users (CHC, n\u2009=\u200917) or non-CHC users (non-CHC, n\u2009=\u200993']","['combined hormonal contraceptive (CHC', 'Combined Hormonal Contraceptive', 'weight-loss intervention that included a reduced-calorie diet, a progressive exercise prescription, and group-based behavioral support']","['weight regain', 'weight loss', 'CHC regained weight', 'Weight Loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]",,0.0745885,"At 6 M, weight was reduced from baseline in both CHC (mean, -6.7 kg; 95% CI: -9.8 to -3.7 kg) and non-CHC (-9.1 kg; -9.1 to -6.4 kg).","[{'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Caldwell', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Adnin', 'Initials': 'A', 'LastName': 'Zaman', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Ostendorf', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Zhaoxing', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Bryan B', 'Initials': 'BB', 'LastName': 'Swanson', 'Affiliation': 'Department of Chemistry and Biochemistry, Colorado College, Colorado Springs, Colorado, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Kinesiology and Public Health Department, California Polytechnic State University, San Luis Obispo, California, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Catenacci', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22787']
3075,31331777,Trivalent influenza vaccination randomized control trial of pregnant women and adverse fetal outcomes.,"INTRODUCTION


The purpose of this study was to evaluate the association of influenza vaccine during pregnancy and adverse fetal outcomes. Preventing fetal death, low birth weight, small for gestational age birth and preterm birth are important potential effects of antenatal maternal influenza immunization for which there are conflicting data.
MATERIALS AND METHODS


A double-blind, randomized, placebo-controlled clinical trial of trivalent inactivated influenza vaccine was conducted in South Africa from March 2011 until after the 2012 influenza season when the infants born had reached the age of 24 weeks. Mothers were administered the vaccine or placebo during pregnancy at a gestation of 20 to 36 weeks. A comparison of rates of fetal death, low birth weight, small for gestational age birth, and preterm birth, between vaccinated and placebo groups was made. Fetal outcome differences between the groups were measured using Student's t-tests, vaccine efficacy with 95% confidence intervals, and Poisson regression for incidence rates. All analyses except fetal death excluded mothers who were administered vaccine or placebo after 34 weeks gestational age.
RESULTS


There were 2116 HIV-uninfected pregnant women age 18 to 38 years in the trial; 2005 infants were born to mothers where vaccine or placebo had been administered ≥ 14 days prior to delivery, and there were 6 miscarriages and 23 stillbirths. There was no significant vaccine efficacy (with [95% confidence interval]) on fetal death (-21.2% [-150.8, 41.4]), low birth weight (-11.1% [-42.3, 12.5]), small for gestational age birth (-9.9% [-35.6, 11.0]), or preterm birth (-21.3% [-60.5, 8.3]). Neither was vaccine efficacy demonstrated when the analysis was restricted to infants of mothers who were exposed to an influenza season (1832 outcomes available).
CONCLUSION


We did not find a beneficial effect of trivalent inactivated influenza vaccine during pregnancy on adverse fetal outcomes.",2019,"There was no significant vaccine efficacy (with [95% confidence interval]) on fetal death (-21.2% [-150.8, 41.4]), low birth weight (-11.1% [-42.3, 12.5]), small for gestational age birth (-9.9% [-35.6, 11.0]), or preterm birth (-21.3% [-60.5, 8.3]).","['pregnant women and adverse fetal outcomes', 'South Africa from March 2011 until after the 2012 influenza season when the infants born had reached the age of 24\u202fweeks', '2116 HIV-uninfected pregnant women age 18 to 38\u202fyears in the trial; 2005 infants were born to mothers where']","['influenza vaccine', 'vaccine or placebo', 'placebo', 'trivalent inactivated influenza vaccine']","['adverse fetal outcomes', 'preterm birth', 'rates of fetal death, low birth weight, small for gestational age birth, and preterm birth', 'fetal death', 'vaccine efficacy', 'low birth weight', 'small for gestational age birth', 'fetal death, low birth weight, small for gestational age birth and preterm birth', ""Student's t-tests, vaccine efficacy""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0015927', 'cui_str': 'Fetal Demise'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",2116.0,0.602901,"There was no significant vaccine efficacy (with [95% confidence interval]) on fetal death (-21.2% [-150.8, 41.4]), low birth weight (-11.1% [-42.3, 12.5]), small for gestational age birth (-9.9% [-35.6, 11.0]), or preterm birth (-21.3% [-60.5, 8.3]).","[{'ForeName': 'Eric A F', 'Initials': 'EAF', 'LastName': 'Simões', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Colorado School of Public Health, Center for Global Health, University of Colorado School of Medicine, Aurora Colorado, 13123 E. 16(th) Ave., B055 Aurora, CO, United States; University of Colorado Denver, Dept. of Pediatric Infectious Diseases, 13123 E. 16(th) Ave, B055 Aurora, CO, United States.'}, {'ForeName': 'Marta C', 'Initials': 'MC', 'LastName': 'Nunes', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Carosone-Link', 'Affiliation': 'University of Colorado Denver, Dept. of Pediatric Infectious Diseases, 13123 E. 16(th) Ave, B055 Aurora, CO, United States. Electronic address: Phyllis.CarosoneLink@ucdenver.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Madimabe', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ortiz', 'Affiliation': 'University of Maryland Center for Vaccine Development, 685 W Baltimore St, Baltimore, MD, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'University of Maryland Center for Vaccine Development, 685 W Baltimore St, Baltimore, MD, USA.'}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'Klugman', 'Affiliation': 'Bill and Melinda Gates Foundation, 500 5th Ave N, Seattle, WA, USA.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; National Institute for Communicable Diseases: a division of National Health Laboratory Service, Centre for Vaccines and Immunology, 1 Modderfontein Road, Sandringham, Johannesburg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2019.07.024']
3076,31444872,Automated Text Messaging With Patients in Department of Veterans Affairs Specialty Clinics: Cluster Randomized Trial.,"BACKGROUND


Acceptability of mobile phone text messaging as a means of asynchronous communication between health care systems and patients is growing. The US Department of Veterans Affairs (VA) has adopted an automated texting system (aTS) for national rollout. The aTS allows providers to develop clinical texting protocols to promote patient self-management and allows clinical teams to monitor patient progress between in-person visits. Texting-supported hepatitis C virus (HCV) treatment has not been previously tested.
OBJECTIVE


Guided by the Practical, Robust Implementation and Sustainability Model (PRISM), we developed an aTS HCV protocol and conducted a mixed methods, hybrid type 2 effectiveness implementation study comparing two programs supporting implementation of the aTS HCV protocol for medication adherence in patients with HCV.
METHODS


Seven VA HCV specialty clinics were randomized to usual aTS implementation versus an augmented implementation facilitation program. Implementation process measures included facilitation metrics, usability, and usefulness. Implementation outcomes included provider and patient use of the aTS HCV protocol, and effectiveness outcomes included medication adherence, health perceptions and behaviors, and sustained virologic response (SVR).
RESULTS


Across the seven randomized clinics, there were 293 facilitation events using a core set of nine implementation strategies (157 events in augmented implementation facilitation, 136 events in usual implementation). Providers found the aTS appropriate with high potential for scale-up but not without difficulties in startup, patient selection and recruitment, and clinic workflow integration. Patients largely found the aTS easy to use and helpful; however, low perceived need for self-management support contributed to high declination. Reach and use was modest with 197 patients approached, 71 (36%) enrolled, 50 (25%) authenticated, and 32 (16%) using the aTS. In augmented implementation facilitation clinics, more patients actively used the aTS HCV protocol compared with usual clinic patients (20% vs 12%). Patients who texted reported lower distress about failing HCV treatment (13/15, 87%, vs 8/15, 53%; P=.05) and better adherence to HCV medication (11/15, 73%, reporting excellent adherence vs 6/15, 40%; P=.06), although SVR did not differ by group.
CONCLUSIONS


The aTS is a promising intervention for improving patient self-management; however, augmented approaches to implementation may be needed to support clinician buy-in and patient engagement. Considering the behavioral, social, organizational, and technical scale-up challenges that we documented, successful and sustained implementation of the aTS may require implementation strategies that operate at the clinic, provider, and patient levels.
TRIAL REGISTRATION


Retrospectively registered at ClinicalTrials.gov NCT03898349; https://clinicaltrials.gov/ct2/show/NCT03898349.",2019,"Patients who texted reported lower distress about failing HCV treatment (13/15, 87%, vs 8/15, 53%; P=.05) and better adherence to HCV medication (11/15, 73%, reporting excellent adherence vs 6/15, 40%; P=.06), although SVR did not differ by group.
",['patients with HCV.\nMETHODS\n\n\nSeven VA HCV specialty clinics'],"['aTS HCV protocol', 'Sustainability Model (PRISM', 'Texting-supported hepatitis C virus (HCV', 'aTS', 'usual aTS implementation versus an augmented implementation facilitation program']","['lower distress about failing HCV treatment', 'facilitation metrics, usability, and usefulness', 'adherence to HCV medication', 'provider and patient use of the aTS HCV protocol, and effectiveness outcomes included medication adherence, health perceptions and behaviors, and sustained virologic response (SVR', 'SVR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0220847', 'cui_str': 'Hepatitis C virus'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4050171', 'cui_str': 'Sustained Virologic Response'}]",293.0,0.0666873,"Patients who texted reported lower distress about failing HCV treatment (13/15, 87%, vs 8/15, 53%; P=.05) and better adherence to HCV medication (11/15, 73%, reporting excellent adherence vs 6/15, 40%; P=.06), although SVR did not differ by group.
","[{'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Yakovchenko', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, Bedford Department of Veterans Affairs Medical Center, Department of Veterans Affairs, Bedford, MA, United States.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Hogan', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, Bedford Department of Veterans Affairs Medical Center, Department of Veterans Affairs, Bedford, MA, United States.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Houston', 'Affiliation': 'Division of Health Informatics and Implementation Science, Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Amherst, MA, United States.'}, {'ForeName': 'Lorilei', 'Initials': 'L', 'LastName': 'Richardson', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, Bedford Department of Veterans Affairs Medical Center, Department of Veterans Affairs, Bedford, MA, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lipschitz', 'Affiliation': ""Brigham and Women's Hospital Department of Psychiatry, Boston, MA, United States.""}, {'ForeName': 'Beth Ann', 'Initials': 'BA', 'LastName': 'Petrakis', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, Bedford Department of Veterans Affairs Medical Center, Department of Veterans Affairs, Bedford, MA, United States.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gillespie', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, Bedford Department of Veterans Affairs Medical Center, Department of Veterans Affairs, Bedford, MA, United States.'}, {'ForeName': 'D Keith', 'Initials': 'DK', 'LastName': 'McInnes', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, Bedford Department of Veterans Affairs Medical Center, Department of Veterans Affairs, Bedford, MA, United States.'}]",Journal of medical Internet research,['10.2196/14750']
3077,32441544,Strengthening resilience in over 50's: a nested clustered-randomized controlled trial of adaptive systematic self-reflection.,"Background and objectives : This study investigated the efficacy of guided self-reflection to strengthen resilience in adults over 50 by exploring the effects of the training on mental health and positive emotional outcomes. Design : A nested clustered-randomized controlled trial was conducted to test the efficacy of the training. Measures occurred at pre-intervention, post-intervention, and at four to five months follow-up. Method:  Two samples of participants were recruited. First, older employees from a consumer goods company took part in the clustered-randomized controlled trial. Ninety-three employees (mean age = 54.02 years; 36.56% females) were assigned to the intervention ( n  = 52) or active control ( n  = 41) group. Second, older adults from the community ( n  = 51) were recruited (mean age = 58.63 years; 80.40% female) and assigned to the intervention only. Results : Improvements were observed in the community sample, compared to the active control group, across a range of wellbeing outcomes. When training engagement was used as a moderator, positive benefits for the corporate intervention group emerged for highly engaged participants. Mediation analyses indicated that stress-as-enhancing mindset, stressor benefit, and coping self-efficacy acted as possible mechanisms for change in primary outcomes. Conclusions : Findings provide support for the use of guided self-reflection for resilience training with older adults.",2020,"Improvements were observed in the community sample, compared to the active control group, across a range of wellbeing outcomes.","['older adults from the community ( n \u2009=\u200951) were recruited (mean age\u2009=\u200958.63 years; 80.40% female', 'older adults', 'Ninety-three employees (mean age\u2009=\u200954.02 years; 36.56% females', 'Method:  Two samples of participants were recruited', ""over 50's""]","['active control', 'guided self-reflection']",['mental health and positive emotional outcomes'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",93.0,0.123693,"Improvements were observed in the community sample, compared to the active control group, across a range of wellbeing outcomes.","[{'ForeName': 'Monique F', 'Initials': 'MF', 'LastName': 'Crane', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Kho', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kangas', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Griffin', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Karin', 'Affiliation': 'eCentre Clinic, Department of Psychology, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Joanne K', 'Initials': 'JK', 'LastName': 'Earl', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Celia B', 'Initials': 'CB', 'LastName': 'Harris', 'Affiliation': 'Department of Cognitive Science, Macquarie University, North Ryde, Australia.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1768375']
3078,32441491,Is the timing of food intake a potential indicator of low weight loss responders? A secondary analysis of three weight loss studies.,"Individual variability in weight loss in response to a weight loss intervention is commonly observed. Recently, the timing of food intake has been identified as one possible factor implicated in obesity and weight loss. The objective of this study was to further characterize low weight loss responders by assessing the pre-diet distribution of daily energy and macronutrient intakes. A pooled cohort of men and women (n = 122; aged 39.1 ± 8.2 years; body mass index [BMI] 33.1 ± 3.8 kg/m 2  ) who participated in a 12 to 15 week energy-restricted intervention (-500 to -700 kcal/d) were included in this study. Participants were categorized into two weight loss groups (ie, low [-1.3 ± 2.3 kg] and high [-6.1 ± 2.1 kg] weight loss). Food intake and distribution of energy and macronutrient intakes were assessed using a 3-day food record at baseline. The daily distribution of energy intake (% of total energy intake) was similar in the two weight loss groups with the exception of the low weight loss group who consumed a slightly lower proportion of their total energy intake before 9:00 am compared with the high weight loss group (12.5% ± 5.8% vs 15.0% ± 6.6%, respectively, P = .03). In the low weight loss group, the percentage of energy intake consumed after 8:00 pm was positively associated with total energy intake (r = 0.27, P = .04). The results of this study suggest that the timing of food intake measured prior to a weight loss intervention does not permit the characterization of low weight loss responders.",2020,"The daily distribution of energy intake (% of total energy intake) was similar in the two weight loss groups with the exception of the low weight loss group who consumed a slightly lower proportion of their total energy intake before 9:00 am compared with the high weight loss group (12.5% ± 5.8% vs 15.0% ± 6.6%, respectively, P = .03).","['Participants were categorized into two weight loss groups (ie, low [-1.3\u2009±\u20092.3\u2009kg] and high [-6.1\u2009±\u20092.1\u2009kg] weight loss', 'men and women (n = 122; aged 39.1\u2009±\u20098.2\u2009years; body mass index [BMI] 33.1\u2009±\u20093.8\u2009kg/m 2  ) who participated in a 12 to 15\u2009week energy-restricted intervention (-500 to -700\u2009kcal/d']",[],"['total energy intake', 'Food intake and distribution of energy and macronutrient intakes', 'percentage of energy intake', 'daily distribution of energy intake']","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",122.0,0.0201082,"The daily distribution of energy intake (% of total energy intake) was similar in the two weight loss groups with the exception of the low weight loss group who consumed a slightly lower proportion of their total energy intake before 9:00 am compared with the high weight loss group (12.5% ± 5.8% vs 15.0% ± 6.6%, respectively, P = .03).","[{'ForeName': 'Raphaëlle', 'Initials': 'R', 'LastName': 'Jacob', 'Affiliation': 'Centre NUTRISS, Institute of Nutrition and Functional Foods (INAF), Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Tremblay', 'Affiliation': 'Centre NUTRISS, Institute of Nutrition and Functional Foods (INAF), Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Panahi', 'Affiliation': 'Centre NUTRISS, Institute of Nutrition and Functional Foods (INAF), Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Provencher', 'Affiliation': 'Centre NUTRISS, Institute of Nutrition and Functional Foods (INAF), Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Drapeau', 'Affiliation': 'Centre NUTRISS, Institute of Nutrition and Functional Foods (INAF), Laval University, Quebec City, Quebec, Canada.'}]",Clinical obesity,['10.1111/cob.12360']
3079,32441571,Effects of inverse ratio ventilation combined with lung protective ventilation on pulmonary function in patients with severe burns for surgery.,"OBJECTIVE


To investigate the effects of inverse ratio ventilation combined with lung-protective ventilation on pulmonary function and inflammatory factors in severe burn patients undergoing surgery.  Populations and Methods : Eighty patients with severe burns undergoing elective surgery were divided randomly into two groups: control (CG,  n  = 40) and experiment (EG,  n  = 40). The CG had conventional ventilation, whereas the EG were ventilated with tidal volume (TV) of 6-8 ml/kg, I (inspiration): E (expiration) of 2:1, and positive end-expiratory pressure (PEEP) 5 cm H2O. The following variables were evaluated before (T0), 1 h after start of surgery (T1) and after surgery (T2): oxygenation index (OI), partial pressure of carbon dioxide (PaCO 2 ), TV, peak airway pressure (Ppeak), mean airway pressure (Pmean), PEEP, pulmonary dynamic compliance (Cdyn), alveolar-arterial difference of oxygen partial pressure D(A-a)O 2 , lactic acid (Lac), interleukin (IL)-6 and IL-10, and lung complications.  Results : At T1 and T2 time points, the OI, Pmean and Cdyn were significantly greater in the EG than in the CG while the TV, Ppeak, D(A-a)O 2 , IL-6 and IL-10 were significantly smaller in the EG than in the CG. At the end of the surgery, the Lac was significantly smaller in the EG than in the CG (1.28 ± 0.19 vs. 1.40 ± 0.23 mmol/L). Twenty-four hours after the surgery, significantly more patients had hypoxemia (27.5 vs. 10.0%), increased expectoration (45.0 vs. 22.5%), increased lung texture or exudation (37.5 vs. 17.5%) in the CG than in the EG.  Conclusions : Inverse ratio ventilation combined with lung-protective ventilation can reduce Ppeak, increase Pmean and Cdyn, improve the pulmonary oxygenation function, and decrease ILs in severe burn surgery patients.",2020,"At T1 and T2 time points, the OI, Pmean and Cdyn were significantly greater in the EG than in the CG while the TV, Ppeak, D(A-a)O 2 , IL-6 and IL-10 were significantly smaller in the EG than in the CG.","['severe burn patients undergoing surgery', 'Populations and Methods ', 'severe burn surgery patients', 'Eighty patients with severe burns undergoing elective surgery', 'patients with severe burns for surgery']","['inverse ratio ventilation combined with lung-protective ventilation', 'inverse ratio ventilation combined with lung protective ventilation', 'Inverse ratio ventilation combined with lung-protective ventilation']","['pulmonary function and inflammatory factors', 'increased lung texture or exudation ', 'OI, Pmean and Cdyn', 'oxygenation index (OI), partial pressure of carbon dioxide (PaCO 2 ), TV, peak airway pressure (Ppeak), mean airway pressure (Pmean), PEEP, pulmonary dynamic compliance (Cdyn), alveolar-arterial difference of oxygen partial pressure D(A-a)O 2 , lactic acid (Lac), interleukin (IL)-6 and IL-10, and lung complications', 'pulmonary oxygenation function', 'increased expectoration', 'pulmonary function', 'Lac', 'TV, Ppeak, D(A-a)O 2 , IL-6 and IL-10', 'hypoxemia ']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0311437', 'cui_str': 'Exudation'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",80.0,0.0594429,"At T1 and T2 time points, the OI, Pmean and Cdyn were significantly greater in the EG than in the CG while the TV, Ppeak, D(A-a)O 2 , IL-6 and IL-10 were significantly smaller in the EG than in the CG.","[{'ForeName': 'Yan-Chao', 'Initials': 'YC', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Huai', 'Affiliation': 'Department of Anesthesiology, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}, {'ForeName': 'Shu-Zhen', 'Initials': 'SZ', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}, {'ForeName': 'Xiao-Wei', 'Initials': 'XW', 'LastName': 'Cao', 'Affiliation': 'Respiratory Department, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}, {'ForeName': 'Bu-Lang', 'Initials': 'BL', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}]",The Libyan journal of medicine,['10.1080/19932820.2020.1767276']
3080,32441557,Lung function changes in patients with chronic obstructive pulmonary disease (COPD) and asthma exposed to secondhand smoke in outdoor areas.,"Background:  Further evidence is needed on the effects that short- and long-term exposure to secondhand smoke (SHS) have on the respiratory health of patients with lung disease. Within the TackSHS project we aimed to assess the acute respiratory effects in lung function that result from short-term SHS exposure among patients with asthma and chronic obstructive pulmonary disease (COPD). Methods:  The study design was an intervention trial with measurements before/after exposure to SHS in legal outdoor smoking areas. We studied patients with asthma or COPD from Czechia, Ireland, and Spain. Forced spirometry, peak flow and carbon monoxide (CO) measurements were performed pre- and 24 h post- exposure. Results:  Overall, 60 patients were studied, 30 with asthma, and 30 with COPD; 35 (58.3%) were female. There were no significant differences observed in exhaled CO between pre- and 24 h post-exposure neither in women ( p  = 0.210), nor in men ( p  = 0.169).A statistically significant decrease in forced vital capacity (FVC) was seen, overall, in asthma participants ( p  = 0.02) and in forced expiratory volume in the first second (FEV 1 ), ( p  = 0.02), FVC ( p  = 0.04) and peak expiratory flow rate (PEFR) ( p  = 0.04) in female asthmatic participants. The observed decreases in respiratory measurements in COPD were not significant. There were no reported increases in symptoms, respiratory medication, or use of health services 24 h after the exposure. Conclusion:  We conclude that acute, short-term SHS exposure had a statistically significant effect on spirometry in female asthma patients but did not significantly modify spirometric indices 24 h later in COPD patients.",2020,"There were no significant differences observed in exhaled CO between pre- and 24 h post-exposure neither in women ( p  = 0.210), nor in men ( p  = 0.169).A statistically significant decrease in forced vital capacity (FVC) was seen, overall, in asthma participants ( p  = 0.02) and in forced expiratory volume in the first second (FEV 1 ), ( p  = 0.02), FVC ( p  = 0.04) and peak expiratory flow rate (PEFR) ( p  = 0.04) in female asthmatic participants.","['patients with lung disease', 'patients with asthma or COPD from Czechia, Ireland, and Spain', 'patients with chronic obstructive pulmonary disease (COPD) and asthma exposed to secondhand smoke in outdoor areas', 'legal outdoor smoking areas', 'patients with asthma and chronic obstructive pulmonary disease (COPD', 'female asthmatic participants', '60 patients were studied, 30 with asthma, and 30 with COPD; 35 (58.3%) were female', 'female asthma patients']",[],"['exhaled CO', 'forced vital capacity (FVC', 'forced expiratory volume', 'respiratory measurements in COPD', 'Forced spirometry, peak flow and carbon monoxide (CO) measurements', 'peak expiratory flow rate (PEFR', 'symptoms, respiratory medication, or use of health services', 'FVC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0429673', 'cui_str': 'Respiratory measure'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0857465', 'cui_str': 'Peak flow'}, {'cui': 'C0201932', 'cui_str': 'Carboxyhemoglobin measurement'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0418986', 'cui_str': 'Respiratory medication'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]",60.0,0.0434038,"There were no significant differences observed in exhaled CO between pre- and 24 h post-exposure neither in women ( p  = 0.210), nor in men ( p  = 0.169).A statistically significant decrease in forced vital capacity (FVC) was seen, overall, in asthma participants ( p  = 0.02) and in forced expiratory volume in the first second (FEV 1 ), ( p  = 0.02), FVC ( p  = 0.04) and peak expiratory flow rate (PEFR) ( p  = 0.04) in female asthmatic participants.","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Keogan', 'Affiliation': 'TobaccoFree Research Institute Ireland, Focas Research Institute, DIT, Dublin, Ireland.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Alonso', 'Affiliation': 'Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Salome', 'Initials': 'S', 'LastName': 'Sunday', 'Affiliation': 'TobaccoFree Research Institute Ireland, Focas Research Institute, DIT, Dublin, Ireland.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Tigova', 'Affiliation': 'Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Esteve', 'Initials': 'E', 'LastName': 'Fernández', 'Affiliation': 'Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'López', 'Affiliation': 'Agència de Salut Pública de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Silvano', 'Initials': 'S', 'LastName': 'Gallus', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Semple', 'Affiliation': 'Institute for Social Marketing, University of Stirling, Stirling, Scotland, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Tzortzi', 'Affiliation': 'Institute of Public Health of the American College of Greece, Athens, Greece.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Boffi', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gorini', 'Affiliation': 'Istituto per lo Studio, la Prevenzione e la Rete Oncologica, Florence, Italy.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'López-Nicolás', 'Affiliation': 'Universidad Politécnica de Cartagena, Cartagena, Spain.'}, {'ForeName': 'Cornel', 'Initials': 'C', 'LastName': 'Radu-Loghin', 'Affiliation': 'European Network for Smoking and Tobacco Prevention, Brussels, Belgium.'}, {'ForeName': 'Joan B', 'Initials': 'JB', 'LastName': 'Soriano', 'Affiliation': 'Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Clancy', 'Affiliation': 'TobaccoFree Research Institute Ireland, Focas Research Institute, DIT, Dublin, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1766062']
3081,31728713,"Analysis of autonomic outcomes in APOLLO, a phase III trial of the RNAi therapeutic patisiran in patients with hereditary transthyretin-mediated amyloidosis.","Hereditary transthyretin-mediated (hATTR) amyloidosis is a progressive, debilitating disease often resulting in early-onset, life-impacting autonomic dysfunction. The effect of the RNAi therapeutic, patisiran, on autonomic neuropathy manifestations in patients with hATTR amyloidosis with polyneuropathy in the phase III APOLLO study is reported. Patients received patisiran 0.3 mg/kg intravenously (n = 148) or placebo (n = 77) once every 3 weeks for 18 months. Patisiran halted or reversed polyneuropathy and improved quality of life from baseline in the majority of patients. At baseline, patients in APOLLO had notable autonomic impairment, as demonstrated by the Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire and Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) questionnaire autonomic neuropathy domain. At 18 months, patisiran improved autonomic neuropathy symptoms compared with placebo [COMPASS-31, least squares (LS) mean difference, - 7.5; 95% CI: - 11.9, - 3.2; Norfolk QOL-DN autonomic neuropathy domain, LS mean difference, - 1.1; - 1.8, - 0.5], nutritional status (modified body mass index, LS mean difference, 115.7; - 82.4, 149.0), and vasomotor function (postural blood pressure, LS mean difference, - 0.3; - 0.5, - 0.1). Patisiran treatment also led to improvement from baseline at 18 months for COMPASS-31 (LS mean change from baseline, - 5.3; 95% CI: - 7.9, - 2.7) and individual domains, orthostatic intolerance (- 4.6; - 6.3, - 2.9) and gastrointestinal symptoms (- 0.8; - 1.5, - 0.2). Rapid worsening of all study measures was observed with placebo, while patisiran treatment resulted in stable or improved scores compared with baseline. Patisiran demonstrates benefit across a range of burdensome autonomic neuropathy manifestations that deteriorate rapidly without early and continued treatment.",2020,"At baseline, patients in APOLLO had notable autonomic impairment, as demonstrated by the Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire and Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) questionnaire autonomic neuropathy domain.","['patients with hATTR amyloidosis with polyneuropathy in the phase III APOLLO study', 'patients with hereditary transthyretin-mediated amyloidosis']","['placebo', 'patisiran 0.3\xa0mg/kg intravenously (n\u2009=\u2009148) or placebo']","['Patisiran halted or reversed polyneuropathy and improved quality of life', 'gastrointestinal symptoms', 'individual domains, orthostatic intolerance', 'notable autonomic impairment', 'autonomic neuropathy symptoms', 'Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire and Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) questionnaire autonomic neuropathy domain', 'vasomotor function (postural blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3896714', 'cui_str': 'patisiran'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C3896714', 'cui_str': 'patisiran'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0034380'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1535893', 'cui_str': 'Orthostatic intolerance'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0259749', 'cui_str': 'Autonomic neuropathy (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0454866', 'cui_str': 'Norfolk (geographic location)'}, {'cui': 'C0011882', 'cui_str': 'Diabetic Neuropathies'}, {'cui': 'C0232365', 'cui_str': 'Vasomotor function (observable entity)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.127789,"At baseline, patients in APOLLO had notable autonomic impairment, as demonstrated by the Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire and Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) questionnaire autonomic neuropathy domain.","[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'González-Duarte', 'Affiliation': 'Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Sección XVI, Tlalpan, CdMx, CP 01400, México City, Mexico. gonzalezduarte@aol.com.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Berk', 'Affiliation': 'Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'Quan', 'Affiliation': 'University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Mauermann', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Hartmut H', 'Initials': 'HH', 'LastName': 'Schmidt', 'Affiliation': 'University of Münster, Münster, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Polydefkis', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Waddington-Cruz', 'Affiliation': 'Hospital Universitário Clementino Fraga Filho-UFRJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mitsuharu', 'Initials': 'M', 'LastName': 'Ueda', 'Affiliation': 'Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'Isabel M', 'Initials': 'IM', 'LastName': 'Conceição', 'Affiliation': 'CHULN, Hospital de Santa Maria and Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Arnt V', 'Initials': 'AV', 'LastName': 'Kristen', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Coelho', 'Affiliation': 'Hospital de Santo António, Centro Hospitalar Universitário Do Porto, Porto, Portugal.'}, {'ForeName': 'Cécile A', 'Initials': 'CA', 'LastName': 'Cauquil', 'Affiliation': 'AP-HP Université Paris Saclay, CHU Bicêtre, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Tard', 'Affiliation': 'Université de Lille, Lille, France.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Merkel', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Aldinc', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Jing Jing', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Adams', 'Affiliation': 'AP-HP, Université Paris Saclay, CHU Bicêtre, Université Paris-Sud, INSERM 1195, Paris, France.'}]",Journal of neurology,['10.1007/s00415-019-09602-8']
3082,32441643,Tocilizumab in giant cell arteritis: differences between the GiACTA trial and a multicentre series of patients from the clinical practice.,"OBJECTIVES


A potential point of concern among clinicians is whether results derived from the clinical trials can be reasonably applied or generalised to a definable group of patients seen in real world. It can be the case of the GiACTA study that is a phase III randomised controlled trial of tocilizumab (TCZ) in giant cell arteritis (GCA). To address this question, we compared the clinical features and the responses to TCZ from the GiACTA trial patients with those from a series of GCA seen in the daily clinical practice.
METHODS


Comparative study of clinical features between patients from the GiACTA trial (overall n=251) and those from a multicentre series of real-world GCA patients undergoing TCZ therapy (n=134). The diagnosis of GCA in the GiACTA trial was established by the ACR modified criteria whereas in the series of real-world patients it was made by using the ACR criteria, a positive biopsy of temporal artery or the presence of imaging techniques consistent with large-vessel vasculitis in individuals who presented cranial symptoms of GCA. GiACTA trial patients received subcutaneous TCZ (162 mg every 1 or 2 weeks) whereas those from the clinical practice series were treated using standard IV dose (8 mg/kg/month) or subcutaneous (162 mg/week).
RESULTS


Real-life patients undergoing TCZ were older with longer disease duration and higher values of ESR and had received conventional immunosuppressive therapy (mainly methotrexate) more commonly than those included in the GiACTA trial. Despite clinical differences, TCZ was equally effective in both GiACTA trial and clinical practice patients. However, serious infections were more commonly observed in GCA patients recruited from the clinical practice.
CONCLUSIONS


Despite clinical differences with patients recruited in clinical trials, data from real-life patients confirm the efficacy of TCZ in GCA.",2020,"RESULTS


Real-life patients undergoing TCZ were older with longer disease duration and higher values of ESR and had received conventional immunosuppressive therapy (mainly methotrexate) more commonly than those included in the GiACTA trial.","['giant cell arteritis', 'clinical features between patients from the GiACTA trial (overall n=251) and those from a multicentre series of real-world GCA patients undergoing TCZ therapy (n=134', 'GiACTA trial patients with those from a series of GCA seen in the daily clinical practice']","['subcutaneous TCZ', 'TCZ', 'conventional immunosuppressive therapy (mainly methotrexate', 'Tocilizumab', 'tocilizumab (TCZ']",['serious infections'],"[{'cui': 'C0039483', 'cui_str': 'Giant cell arteritis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C4510396', 'cui_str': 'Tocilizumab therapy'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.0362626,"RESULTS


Real-life patients undergoing TCZ were older with longer disease duration and higher values of ESR and had received conventional immunosuppressive therapy (mainly methotrexate) more commonly than those included in the GiACTA trial.","[{'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Calderón-Goercke', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Castañeda', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid; Cátedra UAM-Roche, EPID-Future, Universidad Autónoma (UAM), Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Aldasoro', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario de Navarra, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Villa', 'Affiliation': 'Department of Rheumatology, Hospital de Sierrallana, Torrelavega, Cantabria, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Prieto-Peña', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Atienza-Mateo', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Patiño', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid; Cátedra UAM-Roche, EPID-Future, Universidad Autónoma (UAM), Madrid, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Moriano', 'Affiliation': 'Department of Rheumatology, Complejo Asistencial Universitario de León, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Romero-Yuste', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario Universitario Pontevedra, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Narváez', 'Affiliation': 'Department of Rheumatology, Hospital de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Gómez-Arango', 'Affiliation': 'Department of Rheumatology, Hospital Alto Deba, Mondragón, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Pérez-Pampín', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Melero', 'Affiliation': 'Department of Rheumatology, Complexo Hospitalario Universitario de Vigo, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Becerra-Fernández', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de Torrevieja, Alicante, Spain.'}, {'ForeName': 'Marcelino', 'Initials': 'M', 'LastName': 'Revenga', 'Affiliation': 'Department of Rheumatology, Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Álvarez-Rivas', 'Affiliation': 'Department of Rheumatology, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Galisteo', 'Affiliation': 'Department of Rheumatology, Hospital Parc Taulí, Barcelona, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Sivera', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de Elda, Alicante, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Olivé-Marqués', 'Affiliation': 'Department of Rheumatology, Hospital Trías i Pujol, Badalona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Álvarez Del Buergo', 'Affiliation': 'Department of Rheumatology, Hospital Río Carrión, Palencia, Spain.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Marena-Rojas', 'Affiliation': 'Department of Rheumatology, Hospital La Mancha Centro, Alcázar de San Juan, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fernández-López', 'Affiliation': 'Department of Rheumatology, Hospital Universitario Juan Canalejo, A Coruña, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Navarro', 'Affiliation': 'Department of Rheumatology, Hospital General Universitario de Elche, Alicante, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Raya', 'Affiliation': 'Department of Rheumatology and Internal Medicine, Hospital San Cecilio, Granada, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Galindez-Agirregoikoa', 'Affiliation': 'Department of Rheumatology, Hospital de Basurto, Bilbao, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Arca', 'Affiliation': 'Department of Rheumatology, Hospital Universitario San Agustín, Avilés, Spain.'}, {'ForeName': 'Roser', 'Initials': 'R', 'LastName': 'Solans-Laqué', 'Affiliation': 'Department of Internal Medicine, Hospital Valle de Hebrón, Barcelona, Spain.'}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'Conesa', 'Affiliation': 'Department of Rheumatology, Hospital General Universitario de Castellón, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hidalgo', 'Affiliation': 'Department of Rheumatology, Complejo Asistencial Universitario de Salamanca, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Vázquez', 'Affiliation': 'Department of Rheumatology, Hospital Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'José Andrés', 'Initials': 'JA', 'LastName': 'Román-Ivorra', 'Affiliation': 'Department of Rheumatology, Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Loricera', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Lluch', 'Affiliation': 'Department of Rheumatology, Hospital Mateu Orfila, Menorca, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Manrique-Arija', 'Affiliation': 'Department of Rheumatology, Hospital Regional de Málaga, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Vela', 'Affiliation': 'Department of Rheumatology, Hospital General Universitario de Alicante, Spain.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'De Miguel', 'Affiliation': 'Department of Rheumatology, Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Torres-Martín', 'Affiliation': 'Department of Rheumatology, Complejo Asistencial de Ávila, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Nieto', 'Affiliation': 'Department of Rheumatology, Hospital Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ordas-Calvo', 'Affiliation': 'Department of Rheumatology, Hospital Cabueñes, Gijón, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Salgado-Pérez', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario Universitario de Ourense, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Luna-Gomez', 'Affiliation': 'Department of Rheumatology, Hospital Universitario Nuestra Señora de la Candelaria, Tenerife, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'Toyos-Sáenz de Miera', 'Affiliation': 'Department of Rheumatology, Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Nagore', 'Initials': 'N', 'LastName': 'Fernández-Llanio', 'Affiliation': 'Department of Rheumatology, Hospital Arnau de Vilanova, Lérida, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García', 'Affiliation': 'Department of Rheumatology, Hospital Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Larena', 'Affiliation': 'Department of Rheumatology, Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'González-Vela', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Corrales', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Varela-García', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid; Cátedra UAM-Roche, EPID-Future, Universidad Autónoma (UAM), Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Aurrecoechea', 'Affiliation': 'Department of Rheumatology, Hospital de Sierrallana, Torrelavega, Cantabria, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'García-Manzanares', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de Torrevieja, Alicante, Spain.'}, {'ForeName': 'Norberto', 'Initials': 'N', 'LastName': 'Ortego', 'Affiliation': 'Department of Rheumatology and Internal Medicine, Hospital San Cecilio, Granada, Spain.'}, {'ForeName': 'Sabela', 'Initials': 'S', 'LastName': 'Fernández', 'Affiliation': 'Department of Rheumatology, Hospital Universitario San Agustín, Avilés, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ortiz-Sanjuán', 'Affiliation': 'Department of Rheumatology, Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Corteguera', 'Affiliation': 'Department of Rheumatology, Complejo Asistencial de Ávila, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Hernández', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Miguel Á', 'Initials': 'MÁ', 'LastName': 'González-Gay', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain. miguelaggay@hotmail.com.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain. rblanco@humv.es.'}]",Clinical and experimental rheumatology,[]
3083,32441658,A Personalized eHealth Intervention for Lifestyle Changes in Patients With Cardiovascular Disease: Randomized Controlled Trial.,"BACKGROUND


Behavior change methods involving new ambulatory technologies may improve lifestyle and cardiovascular disease outcomes.
OBJECTIVE


This study aimed to provide proof-of-concept analyses of an intervention aiming to increase (1) behavioral flexibility, (2) lifestyle change, and (3) quality of life. The feasibility and patient acceptance of the intervention were also evaluated.
METHODS


Patients with cardiovascular disease (N=149; mean age 63.57, SD 8.30 years; 50/149, 33.5% women) were recruited in the Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) trial and randomized to the Do CHANGE intervention or care as usual (CAU). The intervention involved a 3-month behavioral program in combination with ecological momentary assessment and intervention technologies.
RESULTS


The intervention was perceived to be feasible and useful. A significant increase in lifestyle scores over time was found for both groups (F 2,146.6 =9.99; P<.001), which was similar for CAU and the intervention group (F 1,149.9 =0.09; P=.77). Quality of life improved more in the intervention group (mean 1.11, SD 0.11) than CAU (mean -1.47, SD 0.11) immediately following the intervention (3 months), but this benefit was not sustained at the 6-month follow-up (interaction: P=.02). No significant treatment effects were observed for behavioral flexibility (F 1,149.0 =0.48; P=.07).
CONCLUSIONS


The Do CHANGE 1 intervention was perceived as useful and easy to use. However, no long-term treatment effects were found on the outcome measures. More research is warranted to examine which components of behavioral interventions are effective in producing long-term behavior change.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02946281; https://www.clinicaltrials.gov/ct2/show/NCT02946281.",2020,"Quality of life improved more in the intervention group (mean 1.11, SD 0.11) than CAU (mean -1.47, SD 0.11) immediately following the intervention (3 months), but this benefit was not sustained at the 6-month follow-up (interaction: P=.02).","['Patients With Cardiovascular Disease', 'Patients with cardiovascular disease (N=149; mean age 63.57, SD 8.30 years; 50/149, 33.5% women) were recruited in the Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) trial and randomized to the']","['Personalized eHealth Intervention', 'Do CHANGE intervention or care as usual (CAU', 'behavioral program in combination with ecological momentary assessment and intervention technologies']","['increase (1) behavioral flexibility, (2) lifestyle change, and (3) quality of life', 'lifestyle scores', 'behavioral flexibility', 'Quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0162358', 'cui_str': 'Ecologic Systems'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0162358', 'cui_str': 'Ecologic Systems'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.13002,"Quality of life improved more in the intervention group (mean 1.11, SD 0.11) than CAU (mean -1.47, SD 0.11) immediately following the intervention (3 months), but this benefit was not sustained at the 6-month follow-up (interaction: P=.02).","[{'ForeName': 'Eva Rosalinde', 'Initials': 'ER', 'LastName': 'Broers', 'Affiliation': 'Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Willem Johan', 'Initials': 'WJ', 'LastName': 'Kop', 'Affiliation': 'Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Denollet', 'Affiliation': 'Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Widdershoven', 'Affiliation': 'Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Mart', 'Initials': 'M', 'LastName': 'Wetzels', 'Affiliation': 'University of Technology Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Idowu', 'Initials': 'I', 'LastName': 'Ayoola', 'Affiliation': 'University of Technology Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Piera-Jimenez', 'Affiliation': 'Badalona Serveis Assistencials, Badalona, Spain.'}, {'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Habibovic', 'Affiliation': 'Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands.'}]",Journal of medical Internet research,['10.2196/14570']
3084,32441655,"A Blended Learning System to Improve Motivation, Mood State, and Satisfaction in Undergraduate Students: Randomized Controlled Trial.","BACKGROUND


Smartphone-based learning, or mobile learning (m-learning), has become a popular learning-and-teaching strategy in educational environments. Blended learning combines strategies such as m-learning with conventional learning to offer continuous training, anytime and anywhere, via innovative learning activities.
OBJECTIVE


The main aim of this work was to examine the short-term (ie, 2-week) effects of a blended learning method using traditional materials plus a mobile app-the iPOT mobile learning app-on knowledge, motivation, mood state, and satisfaction among undergraduate students enrolled in a health science first-degree program.
METHODS


The study was designed as a two-armed, prospective, single-blind, randomized controlled trial. Subjects who met the inclusion criteria were randomly assigned to either the intervention group (ie, blended learning involving traditional lectures plus m-learning via the use of the iPOT app) or the control group (ie, traditional on-site learning). For both groups, the educational program involved 13 lessons on basic health science. The iPOT app is a hybrid, multiplatform (ie, iOS and Android) smartphone app with an interactive teacher-student interface. Outcomes were measured via multiple-choice questions (ie, knowledge), the Instructional Materials Motivation Survey (ie, motivation), the Profile of Mood States scale (ie, mood state), and Likert-type questionnaires (ie, satisfaction and linguistic competence).
RESULTS


A total of 99 students were enrolled, with 49 (49%) in the intervention group and 50 (51%) in the control group. No difference was seen between the two groups in terms of theoretical knowledge gain (P=.92). However, the intervention group subjects returned significantly higher scores than the control group subjects for all postintervention assessed items via the motivation questionnaire (all P<.001). Analysis of covariance (ANCOVA) revealed a significant difference in the confusion and bewilderment component in favor of the intervention group (P=.01), but only a trend toward significance in anger and hostility as well as total score. The intervention group subjects were more satisfied than the members of the control group with respect to five out of the six items evaluated: general satisfaction (P<.001), clarity of the instructions (P<.01), clarity with the use of the learning method (P<.001), enough time to complete the proposed exercises (P<.01), and improvement in the capacity to learn content (P<.001). Finally, the intervention group subjects who were frequent users of the app showed stronger motivation, as well as increased perception of greater gains in their English-language competence, than did infrequent users.
CONCLUSIONS


The blended learning method led to significant improvements in motivation, mood state, and satisfaction compared to traditional teaching, and elicited statements of subjective improvement in terms of competence in English.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03335397; https://clinicaltrials.gov/ct2/show/NCT03335397.",2020,"The intervention group subjects were more satisfied than the members of the control group with respect to five out of the six items evaluated: general satisfaction (P<.001), clarity of the instructions (P<.01), clarity with the use of the learning method (P<.001), enough time to complete the proposed exercises (P<.01), and improvement in the capacity to learn content (P<.001).","['undergraduate students enrolled in a health science first-degree program', 'A total of 99 students were enrolled, with 49 (49%) in the intervention group and 50 (51%) in the control group', 'Subjects who met the inclusion criteria', 'Undergraduate Students']","['intervention group (ie, blended learning involving traditional lectures plus m-learning via the use of the iPOT app) or the control group (ie, traditional on-site learning', 'Smartphone-based learning, or mobile learning (m-learning', 'blended learning method using traditional materials plus a mobile app-the iPOT mobile learning app']","['knowledge, motivation, mood state, and satisfaction', 'Motivation, Mood State, and Satisfaction', 'anger and hostility', 'motivation questionnaire', 'increased perception of greater gains in their English-language competence', 'theoretical knowledge gain', 'multiple-choice questions (ie, knowledge), the Instructional Materials Motivation Survey (ie, motivation), the Profile of Mood States scale (ie, mood state), and Likert-type questionnaires (ie, satisfaction and linguistic competence', 'motivation, mood state, and satisfaction']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0444502', 'cui_str': 'First degree'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}]",99.0,0.064006,"The intervention group subjects were more satisfied than the members of the control group with respect to five out of the six items evaluated: general satisfaction (P<.001), clarity of the instructions (P<.01), clarity with the use of the learning method (P<.001), enough time to complete the proposed exercises (P<.01), and improvement in the capacity to learn content (P<.001).","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Lozano-Lozano', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fernández-Lao', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cantarero-Villanueva', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Noguerol', 'Affiliation': 'Departamento de Lenguajes y Sistemas Informáticos e Ingeniería de Software, Universidad Politécnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Álvarez-Salvago', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Cruz-Fernández', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Arroyo-Morales', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Galiano-Castillo', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}]",Journal of medical Internet research,['10.2196/17101']
3085,32441659,"Investigating the Efficacy and Cost-Effectiveness of Technology-Delivered Personalized Feedback on Dietary Patterns in Young Australian Adults in the Advice, Ideas, and Motivation for My Eating (Aim4Me) Study: Protocol for a Randomized Controlled Trial.","BACKGROUND


Web-based health interventions may be easier to access and time efficient relative to face-to-face interventions and therefore may be the most appropriate mode to engage young adults.
OBJECTIVE


This study aims to investigate the impact of 3 different levels of personalized web-based dietary feedback and support on changes in diet quality.
METHODS


The Advice, Ideas, and Motivation for My Eating (Aim4Me) study is a 12-month assessor-blinded, parallel-group randomized controlled trial evaluating the impact of 3 levels of web-based feedback on diet quality, measured using the Australian Recommended Food Score (ARFS). Participants (N=2570) will primarily be recruited via web-based methods and randomized to 1 of 3 groups. Group 1 (control) will receive the Healthy Eating Quiz, a web-based dietary assessment tool that generates a brief feedback report on diet quality. Individuals randomized to this group can use the brief feedback report to make positive dietary changes. Group 2 will receive the Australian Eating Survey, a web-based dietary assessment tool that generates a comprehensive feedback report on diet quality as well as macro- and micronutrient intake. Group 2 will use the comprehensive feedback report to assist in making positive dietary changes. They will also have access to the Aim4Me website with resources on healthy eating and tools to set goals and self-monitor progress. Group 3 will receive the same intervention as Group 2 (ie, the comprehensive feedback report) in addition to a tailored 30-min video consultation with an accredited practicing dietitian who will use the comprehensive feedback report to assist individuals in making positive dietary changes. The self-determination theory was used as the framework for selecting appropriate website features, including goal setting and self-monitoring. The primary outcome measure is change in diet quality. The completion of questionnaires at baseline and 3, 6, and 12 months will be incentivized with a monetary prize draw.
RESULTS


As of December 2019, 1277 participants have been randomized.
CONCLUSIONS


The web-based delivery of nutrition interventions has the potential to improve dietary intake of young adults. However, the level of support required to improve intake is unknown.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12618000325202; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374420.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15999.",2020,"Group 1 (control) will receive the Healthy Eating Quiz, a web-based dietary assessment tool that generates a brief feedback report on diet quality.","['Participants (N=2570) will primarily be recruited via web-based methods and randomized to 1 of 3 groups', 'Young Australian Adults', '1277 participants have been randomized', 'young adults']","['Australian Eating Survey, a web-based dietary assessment tool that generates a comprehensive feedback report on diet quality as well as macro- and micronutrient intake', 'personalized web-based dietary feedback', 'Technology-Delivered Personalized Feedback', 'Healthy Eating Quiz, a web-based dietary assessment tool that generates a brief feedback report on diet quality', 'same intervention as Group 2 (ie, the comprehensive feedback report) in addition to a tailored 30-min video consultation with an accredited practicing dietitian who will use the comprehensive feedback report to assist individuals in making positive dietary changes']",['change in diet quality'],"[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",2570.0,0.0978523,"Group 1 (control) will receive the Healthy Eating Quiz, a web-based dietary assessment tool that generates a brief feedback report on diet quality.","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Haslam', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Pezdirc', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, North Sydney, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Truby', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Clayton, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Attia', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Hutchesson', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Burrows', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Callister', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Bonevski', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Kerr', 'Affiliation': 'School of Public Health, Faculty of Health Sciences, Curtin Institute of Technology, Perth, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Kirkpatrick', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rollo', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'McCaffrey', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Clayton, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Health Sciences, University of Newcastle, Callaghan, Australia.'}]",JMIR research protocols,['10.2196/15999']
3086,32441875,Infant feeding beliefs and practices: Effects of maternal personal characteristics.,"PURPOSE


Information is limited about how mothers make food decisions on behalf of their children. Eating practices are established early in life and are difficult to change, so it is imperative to focus on the caregiver who influences a young child's food preferences and eating behaviors. The purpose of this secondary data analysis was to examine the relationship between maternal characteristics and infant feeding beliefs and practices in a sample of multiparous mothers with a history of a prior preterm infant birth.
DESIGN AND METHODS


Secondary analysis of a subset of data (n = 112) collected from women who participated in a randomized clinical trial (RCT) assessing the efficacy of a home-based intervention to improve maternal and child outcomes. Inclusion criteria for the RCT: women ≥18 years of age at enrollment with a prior preterm live birth >20 and <37 weeks gestation, <24 weeks gestation at enrollment, spoke/read English, and received prenatal care at a regional medical center. Criteria for the subset included: completed the Infant Feeding Questionnaire at 5 months postpartum and had reported a prenatal body mass index (BMI). Univariate correlations and multiple linear regression analyses were used to assess the associations between maternal personal characteristics and infant feeding practices.
RESULTS


Median age of the mothers was 27 years (interquartile range [IQR]: 23-32) with median education of 12 years (IQR: 12-16). More than two-thirds (68%) of the women breastfed their last baby. These women were less likely to be concerned about their infant's hunger (r = -.20; p = .035). After controlling for education, maternal BMI, breastfed last baby, self-esteem, locus of control, and depressive symptoms, decreased maternal age (β = -.35; p < .001) and higher levels of stress (β = .19; p = .042) were associated with greater concern about their infant's hunger. Maternal demographic and psychosocial variables were not found to be statistically significantly associated with either concern about infant overeating and becoming overweight or an awareness of infant's hunger and satiety cues.
PRACTICE IMPLICATIONS


Differences in maternal psychosocial variables and attitudes toward infant feeding may contribute to long term eating habits and weight outcomes in children. A better understanding of maternal variables that influence infant feeding attitudes and practices could improve the design of future intervention studies aimed at mothers at risk for having poor infant feeding practices.",2020,"Maternal demographic and psychosocial variables were not found to be statistically significantly associated with either concern about infant overeating and becoming overweight or an awareness of infant's hunger and satiety cues.
","['children', 'Median age of the mothers was 27\u2009years (interquartile range [IQR]: 23-32) with median education of 12 years (IQR: 12-16', 'Secondary analysis of a subset of data (n\u2009=\u2009112) collected from women who participated', 'multiparous mothers with a history of a prior preterm infant birth', 'women ≥18 years of age at enrollment with a prior preterm live birth >20 and <37 weeks gestation, <24 weeks gestation at enrollment, spoke/read English, and received prenatal care at a regional medical center', 'mothers at risk for having poor infant feeding practices']","['RCT', 'home-based intervention']","['education, maternal BMI, breastfed last baby, self-esteem, locus of control, and depressive symptoms', 'Maternal demographic and psychosocial variables', 'prenatal body mass index (BMI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026751', 'cui_str': 'Multiparous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C1277154', 'cui_str': 'Reads English'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0023953', 'cui_str': 'Locus of Control'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]",,0.112608,"Maternal demographic and psychosocial variables were not found to be statistically significantly associated with either concern about infant overeating and becoming overweight or an awareness of infant's hunger and satiety cues.
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bushaw', 'Affiliation': ""Gillette Children's Specialty Healthcare, Nursing Administration, St. Paul, Minnesota.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Lutenbacher', 'Affiliation': 'Vanderbilt University, School of Nursing, Nashville, Tennessee.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Karp', 'Affiliation': 'Vanderbilt University, School of Nursing, Nashville, Tennessee.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dietrich', 'Affiliation': 'Statistics and Measurement, Vanderbilt University, School of Nursing, Nashville, Tennessee.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Graf', 'Affiliation': 'Vanderbilt University, School of Nursing, Nashville, Tennessee.'}]",Journal for specialists in pediatric nursing : JSPN,['10.1111/jspn.12294']
3087,32441675,Taste Disorders: Effect of Education in Patients With Breast Cancer Receiving Chemotherapy.,"BACKGROUND


For patients with breast cancer treated with certain chemotherapy regimens, taste disorders associated with those regimens can negatively affect quality of life.
OBJECTIVES


This study evaluated the effects of taste disorder-related education on meal satisfaction and sense of taste in Japanese women with breast cancer undergoing chemotherapy.
METHODS


A sample of 53 newly diagnosed women with breast cancer scheduled for chemotherapy treatment were randomly assigned to the control or intervention (nurse-provided education about chemotherapy-associated taste disorders) group. Meal satisfaction and sense of taste were assessed using a visual analog scale.
FINDINGS


The proportions of patients with meal dissatisfaction and impaired sense of taste were lower in the intervention group than in the control group. Although meal dissatisfaction and impaired sense of taste recovered in the intervention group two months after protocol completion, they did not recover in the control group. Providing education to women with breast cancer scheduled for chemotherapy treatment can affect patients' experience of treatment-associated taste disorders.
",2020,The proportions of patients with meal dissatisfaction and impaired sense of taste were lower in the intervention group than in the control group.,"['Japanese women with breast cancer undergoing chemotherapy', '53 newly diagnosed women with breast cancer scheduled for chemotherapy treatment', 'women with breast cancer scheduled for', 'patients with breast cancer treated with', 'Patients With Breast Cancer Receiving Chemotherapy']","['certain chemotherapy', 'control or intervention (nurse-provided education about chemotherapy-associated taste disorders', 'taste disorder-related education', 'chemotherapy treatment']","['meal dissatisfaction and impaired sense of taste', 'Meal satisfaction and sense of taste']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0039338', 'cui_str': 'Disorder of taste'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}]",53.0,0.0314989,The proportions of patients with meal dissatisfaction and impaired sense of taste were lower in the intervention group than in the control group.,"[{'ForeName': 'Sanae', 'Initials': 'S', 'LastName': 'Asano', 'Affiliation': 'Hiroshima University.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sawatari', 'Affiliation': 'Hiroshima University.'}, {'ForeName': 'Hideko', 'Initials': 'H', 'LastName': 'Mentani', 'Affiliation': 'Shimizugaoka Senior High School.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': 'Higashihiroshima Medical Center.'}, {'ForeName': 'Michie', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Hakodate Gryoukaku Hospital.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Fudano', 'Affiliation': 'Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Hiroshima City Asa Citizens Hospital.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Niitani', 'Affiliation': ""Yasuda Women's University.""}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Hiroshima University.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Kataoka', 'Affiliation': 'Hiroshima Kosei Hospital.'}]",Clinical journal of oncology nursing,['10.1188/20.CJON.265-271']
3088,31439338,Antithrombotic Therapy and Cardiovascular Outcomes After Transcatheter Aortic Valve Replacement in Patients With Atrial Fibrillation.,"OBJECTIVES


The study sought to determine the patterns of antithrombotic therapy and association with clinical outcomes in patients with atrial fibrillation (AF) and CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category) score ≥2 following transcatheter aortic valve replacement (TAVR).
BACKGROUND


The impact of antithrombotic regimens on clinical outcomes in patients with AF and severe aortic stenosis treated with TAVR is unknown.
METHODS


In the randomized PARTNER II (Placement of Aortic Transcatheter Valve II) trial and associated registries, 1,621 patients with prior AF and CHA 2 DS 2 -VASc score ≥2 comprised the study cohort. Outcomes were analyzed according to antithrombotic therapy.
RESULTS


During the 5-year enrollment period, 933 (57.6%) patients were discharged on oral anticoagulant therapy (OAC). Uninterrupted antiplatelet therapy (APT) for at least 6 months or until an endpoint event was used in 544 of 933 (58.3%) of patients on OAC and 77.5% of patients not on OAC. At 2 years, patients on OAC had a similar rate of stroke (6.6% vs. 5.6%; p = 0.53) and the composite outcome of death or stroke (29.7% vs. 31.8%; p = 0.33), compared with no OAC. OAC with APT was associated with a reduced rate of stroke (5.4% vs. 11.1%; p = 0.03) and death or stroke (29.7% vs. 40.1%; p = 0.01), compared with no OAC or APT. Following adjustment, OAC with APT and APT alone were both associated with reduced rates of stroke compared with no OAC or APT (hazard ratio for OAC+APT: 0.43, 95% confidence interval: 0.22 to 0.85; p = 0.015; hazard ratio for APT alone: 0.32, 95% confidence interval: 0.16 to 0.65; p = 0.002), while OAC alone was not.
CONCLUSIONS


Among patients with prior AF undergoing TAVR, antiplatelet with or without anticoagulant therapy was associated with a reduced risk of stroke at 2 years, implicating multifactorial stroke mechanisms in this population.",2019,"Following adjustment, OAC with APT and APT alone were both associated with reduced rates of stroke compared with no OAC or APT (hazard ratio for OAC+APT: 0.43, 95% confidence interval: 0.22 to 0.85; p = 0.015; hazard ratio for APT alone: 0.32, 95% confidence interval: 0.16 to 0.65; p = 0.002), while OAC alone was not.
","['1,621 patients with prior AF and CHA 2 DS 2 -VASc score\xa0≥2 comprised the study cohort', 'patients with prior AF undergoing TAVR, antiplatelet with or without', 'patients with atrial fibrillation (AF) and CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age\xa0≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category) score\xa0≥2 following transcatheter aortic valve replacement (TAVR', 'Patients With Atrial Fibrillation', 'patients with AF and severe aortic stenosis treated with TAVR is unknown']","['antithrombotic regimens', 'Transcatheter Aortic Valve Replacement', 'oral anticoagulant therapy (OAC', 'anticoagulant therapy', 'Uninterrupted antiplatelet therapy (APT']","['death or stroke', 'rate of stroke', 'rates of stroke', 'Antithrombotic Therapy and Cardiovascular Outcomes', 'composite outcome of death or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0003645', 'cui_str': 'APT'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",1621.0,0.0749304,"Following adjustment, OAC with APT and APT alone were both associated with reduced rates of stroke compared with no OAC or APT (hazard ratio for OAC+APT: 0.43, 95% confidence interval: 0.22 to 0.85; p = 0.015; hazard ratio for APT alone: 0.32, 95% confidence interval: 0.16 to 0.65; p = 0.002), while OAC alone was not.
","[{'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosmidou', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. Electronic address: ik2394@cumc.columbia.edu.'}, {'ForeName': 'Yangbo', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Alu', 'Affiliation': 'Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Mengdan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Madhavan', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Chakravarty', 'Affiliation': 'Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Makkar', 'Affiliation': 'Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'Department of Cardiac Surgery, Medstar Heart and Vascular Institute/Georgetown University, Washington, DC.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Biviano', 'Affiliation': 'Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Susheel', 'Initials': 'S', 'LastName': 'Kodali', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.06.001']
3089,31439336,Renal Function and Outcomes With Dabigatran Dual Antithrombotic Therapy in Atrial Fibrillation Patients After PCI.,"OBJECTIVES


The study sought to evaluate the effect of dabigatran dual therapy versus warfarin triple therapy across categories of renal function in the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy with Dabigatran versus Triple Therapy with Warfarin in Patients with Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial.
BACKGROUND


The RE-DUAL PCI (NCT02164864) trial of patients with atrial fibrillation undergoing percutaneous coronary intervention reported that dabigatran dual therapy (110 or 150 mg twice daily, plus clopidogrel or ticagrelor) reduced the primary endpoint of major bleeding events (MBE) or clinically relevant nonmajor bleeding events (CRNMBE) compared with warfarin triple therapy, with noninferiority in overall thromboembolic events.
METHODS


Risk of a first MBE or CRNMBE and the composite of death or thromboembolic event (DTE) or unplanned revascularization were evaluated in 2,725 patients according to baseline creatinine clearance (CrCl) categories: 30 to <50, 50 to <80, and ≥80 ml/min.
RESULTS


Compared with warfarin, dabigatran 110 mg dual therapy reduced risk of MBE or CRNMBE across all categories of CrCl (p for interaction = 0.19). Dabigatran 150 mg dual therapy reduced risk of MBE or CRNMBE regardless of the CrCl category (p for interaction = 0.31). Risk of DTE or unplanned revascularization was similar to warfarin triple therapy for dabigatran 110 mg dual therapy across all CrCl categories. Dabigatran 150 mg dual therapy versus warfarin triple therapy had similar risk for DTE or unplanned revascularization in patients with CrCl 30 to <80 ml/min and lower risk at CrCl ≥80 ml/min (p for interaction = 0.02).
CONCLUSIONS


In the RE-DUAL PCI trial, dabigatran dual therapy reduced bleeding events versus warfarin triple therapy irrespective of renal function, with overall similar risks of thromboembolic events but lower risks with dabigatran 150 mg in patients with normal CrCl.",2019,Dabigatran 150 mg dual therapy versus warfarin triple therapy had similar risk for DTE or unplanned revascularization in patients with CrCl 30 to <80 ml/min and lower risk at CrCl ≥80 ,"['Patients with Nonvalvular Atrial Fibrillation', 'patients with normal CrCl', 'Atrial\xa0Fibrillation Patients After PCI', 'patients with atrial fibrillation undergoing percutaneous coronary intervention reported that', '2,725 patients according to baseline creatinine clearance (CrCl) categories: 30\xa0to']","['Dabigatran versus Triple Therapy with Warfarin', 'dabigatran dual therapy', 'warfarin triple therapy', 'clopidogrel or ticagrelor', 'Dabigatran 150\xa0mg dual therapy versus warfarin triple therapy', 'warfarin, dabigatran', 'Dabigatran Dual Antithrombotic Therapy', 'Dabigatran']","['risk of MBE', 'major bleeding events (MBE) or clinically relevant nonmajor bleeding events (CRNMBE', 'risk for DTE or unplanned revascularization', 'bleeding events', 'composite of death or thromboembolic event (DTE) or unplanned revascularization', 'overall thromboembolic events', 'Risk of DTE or unplanned revascularization', 'risk of MBE or CRNMBE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2725.0,0.0532282,Dabigatran 150 mg dual therapy versus warfarin triple therapy had similar risk for DTE or unplanned revascularization in patients with CrCl 30 to <80 ml/min and lower risk at CrCl ≥80 ,"[{'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Department of Cardiology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany. Electronic address: hohnloser@em.uni-frankfurt.de.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Département Hospitalo-Universitaire, French Alliance for Cardiovascular Trials (FACT), Hôpital Bichat, Paris, France; Université Paris Diderot, Paris, France; INSERM U_1148, Paris, France; Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala, Sweden.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Nickenig', 'Affiliation': 'Medizinische Klinik und Poliklinik II, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Kiss', 'Affiliation': 'Medical Centre, Hungarian Defence Forces, Budapest, Hungary.'}, {'ForeName': 'Zeki', 'Initials': 'Z', 'LastName': 'Ongen', 'Affiliation': 'Department of Cardiology, Istanbul University Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Navarro Estrada', 'Affiliation': 'Department of Cardiology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Oude Ophuis', 'Affiliation': 'Department of Cardiology, Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kleine', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Jurrien M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.05.050']
3090,32441759,A smartphone game to prevent HIV among young Kenyans: local perceptions of mechanisms of effect.,"Electronic games delivered via smartphones have the potential to become valuable tools in HIV prevention in high-prevalence and low-resource international settings. To ground theoretical elaboration around novel mHealth interventions in contextual realities, it is important to understand the mechanisms of their effects as perceived by local populations. Such perspectives are particularly important when working cross-culturally. 'Tumaini' is an interactive narrative-based smartphone game that uses a 'choose-your-own-adventure' format. It is designed to prevent HIV among young African adolescents (aged 11-14) by increasing age and condom use at first sex. It was developed with a US-based commercial game developer and is grounded in social behavioral theory, evidence-based practice and contextually relevant scenarios. In a 2017 randomized pilot study (n = 60) in Western Kenya, 'Tumaini' showed promising effects on behavioral mediators of sexual debut. In subsequent focus group discussions, adolescent participants and their parents shared their perceptions of the game's mechanisms of effect, which included motivation to play, future orientation, decision-making, relationship to a diverse range of characters and a bridging of the virtual and real worlds. These findings align with our theoretical framework, confirm its successful translation into the intervention and will inform mediation analyses in an upcoming efficacy trial.",2020,"In a 2017 randomized pilot study (n = 60) in Western Kenya, 'Tumaini' showed promising effects on behavioral mediators of sexual debut.","[""2017 randomized pilot study (n\u2009=\u200960) in Western Kenya, 'Tumaini"", 'young African adolescents (aged 11-14) by increasing age and condom use at first sex']",[],['behavioral mediators of sexual debut'],"[{'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",,0.0581283,"In a 2017 randomized pilot study (n = 60) in Western Kenya, 'Tumaini' showed promising effects on behavioral mediators of sexual debut.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Winskell', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sabben', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Akelo', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': ""Ondeng'e"", 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Odero', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mudhune', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, HIV Research Branch, Kisumu, Kenya.'}]",Health education research,['10.1093/her/cyaa011']
3091,32437857,"Is a two-step impression mandatory for complete denture fabrication on the severely resorbed mandible? A randomized trial on mastication, patient satisfaction and adjustments.","OBJECTIVES


To compare one- vs two-step impression procedures for the provision of conventional complete dentures (CCDs) for edentulous individuals with severe mandibular resorption, in terms of (1) masticatory performance and ability; (2) satisfaction with mandibular CCDs; and (3) post-delivery adjustments.
METHODS


Fifty-two patients requiring maxillary + mandibular CCDs were randomly divided into two parallel arms according to the impression method of the mandibular ridge: (SI) single impression with stock trays (irreversible hydrocolloid); (TI) two-step impression in custom trays, with border molding (impression compound) followed by the impression itself (polyether). Mastication performance was evaluated by a colorimetric test, whereas patients answered questions on masticatory ability and satisfaction with mandibular CCDs (100-mm visual analogue scale). The number of post-delivery sessions for adjustments were also quantified. Outcomes were assessed at 3 and 6 months after delivery.
RESULTS


The masticatory performance was similar for both groups, regardless of time (3 months, P = 0.62; 6 months, P = 0.61). No significant difference was found for patient-reported (P > 0.05), i.e. masticatory ability (general ease of chewing and quality of grinding food; ability to chew specific foods), general satisfaction with the mandibular CCD (general satisfaction, comfort, aesthetics, ability to speak and to perform correct cleaning, retention and stability). Both methods resulted in a similar number of post-delivery adjustment sessions [SI: 3.8 (1.7); TI: 3.2 (1.4); P = 0.09].
CONCLUSIONS


Compared to a traditional approach, CCDs obtained from a single impression achieve similar masticatory performance/ability and patient satisfaction, even in patients with severely reabsorbed mandibular ridge. Both methods demand the same amount of post-delivery adjustment.
CLINICAL SIGNIFICANCE


A simplified impression technique which eliminates the secondary impression can provide CCDs of good clinical quality, which influences the OHRQoL, and satisfaction in the same extent they would by a two-step procedure, even for patients with severely reabsorbed mandibular ridges (ClinicalTrials.gov: NCT02339194).",2020,"The masticatory performance was similar for both groups, regardless of time (3 months, P = 0.62; 6 months, P = 0.61).","['patients with severely reabsorbed mandibular ridge', 'Fifty-two patients requiring maxillary\u2009+\u2009mandibular CCDs', 'edentulous individuals with severe mandibular resorption, in terms of (1) masticatory performance and ability; (2) satisfaction with mandibular CCDs; and (3) post-delivery adjustments']","['impression method of the mandibular ridge: (SI) single impression with stock trays (irreversible hydrocolloid); (TI) two-step impression in custom trays, with border molding (impression compound) followed by the impression itself (polyether', 'conventional complete dentures (CCDs']","['masticatory performance', 'Mastication performance', 'masticatory ability (general ease of chewing and quality of grinding food; ability to chew specific foods), general satisfaction with the mandibular CCD (general satisfaction, comfort, aesthetics, ability to speak and to perform correct cleaning, retention and stability', 'masticatory ability and satisfaction with mandibular CCDs (100-mm visual analogue scale', 'masticatory performance/ability and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0453908', 'cui_str': 'Stocking'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0020266', 'cui_str': 'Hydrocolloid'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0426103', 'cui_str': 'Fetal head molding'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}]","[{'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0566339', 'cui_str': 'Ability to chew'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0008928', 'cui_str': 'Cleidocranial dysostosis'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0564214', 'cui_str': 'Ability to speak'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",52.0,0.0678577,"The masticatory performance was similar for both groups, regardless of time (3 months, P = 0.62; 6 months, P = 0.61).","[{'ForeName': 'Ivo S', 'Initials': 'IS', 'LastName': 'Albuquerque', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil.'}, {'ForeName': 'Karina M', 'Initials': 'KM', 'LastName': 'Freitas-Pontes', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil. Electronic address: kamatthes@yahoo.com.br.'}, {'ForeName': 'Raphael F', 'Initials': 'RF', 'LastName': 'de Souza', 'Affiliation': 'Oral Health and Society, Faculty of Dentistry, McGill University, 2001 McGill College Ave, Suite 500, Montreal, Quebec, Canada.'}, {'ForeName': 'Wagner A', 'Initials': 'WA', 'LastName': 'Negreiros', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil.'}, {'ForeName': 'Marcelo B', 'Initials': 'MB', 'LastName': 'Ramos', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil.'}, {'ForeName': 'Raniel F', 'Initials': 'RF', 'LastName': 'Peixoto', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil.'}, {'ForeName': 'Rômulo R', 'Initials': 'RR', 'LastName': 'Regis', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103357']
3092,32437174,"A transdiagnostic minority stress intervention for gender diverse sexual minority women's depression, anxiety, and unhealthy alcohol use: A randomized controlled trial.","OBJECTIVE


To remedy the notable gap in evidence-based treatments for sexual minority women, this study tested the efficacy of a minority-stress-focused cognitive-behavioral treatment intended to improve this population's mental and behavioral health.
METHOD


The intervention, EQuIP (Empowering Queer Identities in Psychotherapy), was adapted from a transdiagnostic cognitive-behavioral treatment as also recently adapted for sexual minority men. Sexual minority women at risk of mental and behavioral health problems ( n  = 19) and expert providers with this population ( n  = 12) shaped the treatment's development, including by supporting its primary focus on universal and minority-stress-focused processes underlying this population's disproportionately poor mental and behavioral health. The resulting treatment was then delivered to young adult sexual minority women ( n  = 60;  M  age = 25.58; 41.67% racial/ethnic minority; 43.33% transgender/nonbinary) experiencing depression/anxiety and past 90-day heavy alcohol use.
RESULTS


Compared to waitlist ( n  = 30), participants randomized to immediately receive EQuIP ( n  = 30) experienced significantly reduced depression and anxiety ( d  = 0.85, 0.86, respectively); effects for alcohol use problems were smaller ( d  = 0.29) and marginally significant. In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
CONCLUSIONS


This study provides initial support for a minority-stress-focused transdiagnostic cognitive-behavioral treatment for sexual minority women. These first results can launch exploration of other mechanisms and modalities through which to equip this population with evidence-based support. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
","['sexual minority men', ""Sexual minority women at risk of mental and behavioral health problems ( n  = 19) and expert providers with this population ( n  = 12) shaped the treatment's development, including by supporting its primary focus on universal and minority-stress-focused processes underlying this population's disproportionately poor mental and behavioral health"", ""gender diverse sexual minority women's depression, anxiety, and unhealthy alcohol use"", 'sexual minority women', 'young adult sexual minority women ( n  = 60;  M  age = 25.58; 41.67% racial/ethnic minority; 43.33% transgender/nonbinary) experiencing depression/anxiety and past 90-day heavy alcohol use']","['transdiagnostic minority stress intervention', 'EQuIP']","['universal risk factors', 'depression and anxiety']","[{'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]","[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0292329,"In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Pachankis', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'McConocha', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Kirsty A', 'Initials': 'KA', 'LastName': 'Clark', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Kriti', 'Initials': 'K', 'LastName': 'Behari', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Fetzner', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Cal D', 'Initials': 'CD', 'LastName': 'Brisbin', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Jillian R', 'Initials': 'JR', 'LastName': 'Scheer', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Lehavot', 'Affiliation': 'Denver-Seattle Center of Innovation for Veteran-Centered and Value-Driven Care.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000508']
3093,32437191,Child skills training for attention-deficit/hyperactivity disorder (ADHD): A randomized controlled trial of structured dyadic behavior therapy (SDBT).,"This pilot study examined structured dyadic behavior therapy (SDBT) as a novel, child skills training intervention for attention-deficit/hyperactivity disorder (ADHD). The purpose of this study was to (a) pilot the feasibility of SDBT, a manualized, child skills training intervention, (b) determine the potential clinical benefits of SDBT as an independent psychotherapy for ADHD, and (c) examine parents' intervention acceptability. Children of 8-12 years of age with ADHD-combined type ( N  = 34) were randomly assigned to either SDBT or an ""attention control"" condition receiving child-centered dyadic therapy (CCDT). SDBT targeted high-frequency behavioral and social demands often challenging for children with ADHD. CCDT provided nondirective, experiential psychotherapy without any contingency management methods. Descriptive data revealed a high level of treatment attendance and completion (90%) for both conditions. General linear modeling techniques (multivariate analysis of variance) examined group differences in ADHD outcomes. Results indicated statistically significant differences between the two groups, with greater ADHD symptom reduction for SDBT (Wilks' λ = .61),  F (3, 30) = 6.36,  p  = .002, η p ² = .39. SDBT also demonstrated clinically meaningful changes, with ADHD symptom severity reduced below categorical levels of functional impairment. Despite superior behavioral outcomes for SDBT, intervention acceptability did not significantly differ for the two psychotherapies. Results support SDBT as a feasible, clinically promising, and acceptable intervention for ADHD. Parent satisfaction ratings suggest dyadic therapies may benefit participants beyond symptom reduction. Implications for intervention portability and treating ADHD without direct adult participation are discussed. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Results indicated statistically significant differences between the two groups, with greater ADHD symptom reduction for SDBT","['attention-deficit/hyperactivity disorder (ADHD', 'Children of 8-12 years of age with ADHD-combined type ( N  = 34', 'children with ADHD']","['SDBT or an ""attention control"" condition receiving child-centered dyadic therapy (CCDT', 'SDBT', 'child skills training intervention', 'structured dyadic behavior therapy (SDBT', 'Child skills training']",[],"[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],34.0,0.0342802,"Results indicated statistically significant differences between the two groups, with greater ADHD symptom reduction for SDBT","[{'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Curtis', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Corey L', 'Initials': 'CL', 'LastName': 'Heath', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Hogan', 'Affiliation': 'Pediatric Medical Group.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000294']
3094,32441668,Efficacy of fenugreek seed extract on men's psychological and physical health: a randomized placebo-controlled double-blind clinical trial.,"Objectives Limited research has examined the effects of fenugreek (Trigonella foenum-graecum L.) supplementation to improve healthy younger men's aging male symptoms. The study objective was to examine whether a fenugreek seed extract would improve healthy men's aging male symptoms, health-related quality of life (HRQoL), grip strength, and anxiety. Methods Randomized double-blind placebo-controlled trial was employed, using a parallel design, with assessments at baseline, Day 30, and Day 60. Healthy male volunteers (n = 57, mean age = 26.1 years) were randomized to: fenugreek 400 mg/d (n = 19), fenugreek 500 mg/d (n = 19), or placebo group (n = 19). Results The fenugreek groups reported significant improvements in aging male symptoms, anxiety levels, grip strength, and indicators of HRQoL compared to the placebo group, p's < 0.05. No adverse events were reported. Conclusion Fenugreek supplementation is an effective nutritional intervention for improving aging male symptoms, anxiety levels, grip strength, and aspects of HRQoL in healthy recreationally active men. Future researchers are encouraged to examine the health and ergogenic effects of fenugreek supplementation in hypogonadal and older populations. Trial registration Clinicaltrials.gov identifier NCT03528538.",2020,"The fenugreek groups reported significant improvements in aging male symptoms, anxiety levels, grip strength, and indicators of HRQoL compared to the placebo group, p's < 0.05.","['Healthy male volunteers (n\xa0=\xa057, mean age\xa0=\xa026.1 years', ""healthy younger men's aging male symptoms"", ""men's psychological and physical health"", 'healthy recreationally active men', 'hypogonadal and older populations']","['fenugreek (Trigonella foenum-graecum L.) supplementation', 'fenugreek seed extract', 'placebo']","[""healthy men's aging male symptoms, health-related quality of life (HRQoL), grip strength, and anxiety"", 'aging male symptoms, anxiety levels, grip strength, and indicators of HRQoL', 'adverse events']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0060207', 'cui_str': 'Fenugreek'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1178580', 'cui_str': 'Fenugreek seed preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.660738,"The fenugreek groups reported significant improvements in aging male symptoms, anxiety levels, grip strength, and indicators of HRQoL compared to the placebo group, p's < 0.05.","[{'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Hausenblas', 'Affiliation': 'School of Applied Health Sciences, Professor, Brooks Rehabilitation College of Healthcare Sciences, Jacksonville University, 2800 University Boulevard North, Jacksonville, FL 32211, USA.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Conway', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, Jacksonville, USA.'}, {'ForeName': 'Kevin R M', 'Initials': 'KRM', 'LastName': 'Coyle', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, Jacksonville, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Barton', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, Jacksonville, USA.'}, {'ForeName': 'Lacie D', 'Initials': 'LD', 'LastName': 'Smith', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, Jacksonville, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Esposito', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, Jacksonville, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, Jacksonville, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Oakes', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, Jacksonville, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Hooper', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, Jacksonville, USA.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0101']
3095,32441691,Wellness Coaching: An Intervention to Increase Healthy Behavior in Breast Cancer Survivors.,"BACKGROUND


Regular physical activity after breast cancer diagnosis improves survival rates and quality of life (QOL). However, breast cancer survivors rarely meet guidelines for recommended levels of physical activity. Wellness coaching interventions (WCIs) have improved exercise and health behaviors in other patient populations.
OBJECTIVES


This study assessed the feasibility and effectiveness of WCIs for increasing physical activity in breast cancer survivors; secondary measures included changes in dietary habits, weight, and QOL.
METHODS


20 obese or overweight breast cancer survivors who recently completed active breast cancer treatment were recruited into a single-arm, 12-week WCI pilot feasibility study. The intervention was comprised of one in-person wellness coaching visit followed by four telephone calls over 12 weeks and 12 weekly emails containing wellness recommendations.
FINDINGS


Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL. Forty percent of participants achieved the 3% postintervention weight-loss goal, but this was not sustained at 30 weeks.
",2020,"FINDINGS


Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL.","['Breast Cancer Survivors', 'breast cancer survivors', '20 obese or overweight breast cancer survivors who recently completed active breast cancer treatment']","['WCIs', 'Wellness coaching interventions (WCIs', 'person wellness coaching visit followed by four telephone calls over 12 weeks and 12 weekly emails containing wellness recommendations', 'Wellness Coaching']","['dietary habits, weight, and QOL', 'physical activity level, dietary habits', 'survival rates and quality of life (QOL']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0242179,"FINDINGS


Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL.","[{'ForeName': 'Daniela L', 'Initials': 'DL', 'LastName': 'Stan', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Cutshall', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Tammy F', 'Initials': 'TF', 'LastName': 'Adams', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Ghosh', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Kaisa C', 'Initials': 'KC', 'LastName': 'Wieneke', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Esayas B', 'Initials': 'EB', 'LastName': 'Kebede', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Bonnie J', 'Initials': 'BJ', 'LastName': 'Donelan Dunlap', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Hazelton', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Alissa M', 'Initials': 'AM', 'LastName': 'Butts', 'Affiliation': 'Medical College of Wisconsin.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Jenkins', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Ivana T', 'Initials': 'IT', 'LastName': 'Croghan', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Bauer', 'Affiliation': 'Mayo Clinic.'}]",Clinical journal of oncology nursing,['10.1188/20.CJON.305-315']
3096,32057470,New surgical instrument for the treatment of condylar fractures: the digitised condylar retractor.,"Reduction is one of the most difficult steps in condylar fracture surgery, and a key factor governing the postoperative outcome. In this study we evaluated quantitatively the effects of a digitised condylar retractor on the duration and rate of reduction. In a prospective, randomised, controlled clinical trial, 48 patients with unilateral condylar fractures who were listed for surgical treatment were randomised to an experimental and a control group (n=24 in each). The experimental group was treated with a digitised condylar retractor, and the control group with traditional surgical instruments only. The primary outcome variables were duration and rate of reduction. The continuity correction chi squared test and independent samples t test were used for statistical analyses. The results showed that the mean reduction time was 21.3minutes in the experimental group and 42.4minutes in the control group (p=2.48*10 -8 , <0.001). The reduction rate was 21/24 in the experimental group and 17/24 in the control group (p=0.16). The results indicated that the mean duration of reduction was significantly shorter, and the reduction rate was higher, in the experimental group than among controls. In conclusion, the digitised condylar retractor can assist surgeons to improve efficiency and accuracy in the reduction of condylar fractures, so it merits promotion as an aid to their surgical treatment.",2020,The reduction rate was 21/24 in the experimental group and 17/24 in the control group (p=0.16).,"['condylar fractures', '48 patients with unilateral condylar fractures who were listed for surgical treatment']","['digitised condylar retractor, and the control group with traditional surgical instruments only', 'digitised condylar retractor']","['duration and rate of reduction', 'mean reduction time', 'reduction rate', 'mean duration of reduction']","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0183014', 'cui_str': 'Retractor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0038928', 'cui_str': 'Surgical Instruments'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",48.0,0.0188266,The reduction rate was 21/24 in the experimental group and 17/24 in the control group (p=0.16).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Dept. of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, PR China. Electronic address: drliulei@163.com.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.01.027']
3097,31439215,Biomarkers and Clinical Cardiovascular Outcomes With Ezetimibe in the IMPROVE-IT Trial.,"BACKGROUND


Addition of ezetimibe to statin therapy reduces the risk of recurrent cardiovascular (CV) events in patients with prior acute coronary syndrome (ACS). The role of biomarkers in identifying subsets of patients who may derive greater clinical benefit with ezetimibe is unknown.
OBJECTIVES


This study sought to evaluate the role of established CV biomarkers in assessing likely benefit with ezetimibe added to statin therapy in post-ACS patients.
METHODS


In a pre-specified nested analysis within a randomized, double-blind trial of ezetimibe/simvastatin versus placebo/simvastatin (IMPROVE-IT [Improved Reduction of Outcomes: Vytorin Efficacy International Trial]), high-sensitivity troponin T, N-terminal pro-B-type natriuretic peptide, growth-differentiation factor-15, and high-sensitivity C-reactive protein was measured in 7,195 patients stabilized (1 month post-randomization) after ACS. A multimarker approach based on biomarker values was used to examine the risk of recurrent CV events and clinical benefit with ezetimibe.
RESULTS


Elevated levels of each biomarker were independently associated with higher risks of CV death/myocardial infarction/stroke and CV death/heart failure (p trend  < 0.001 for each). There was a pattern of greater absolute risk reduction in CV death/myocardial infarction/stroke with the addition of ezetimibe to statin therapy in patients at higher risk on the basis of biomarker levels. High-risk patients (≥3 biomarkers ""positive""; n = 1,437) had an absolute risk difference of -7.3% (95% confidence interval: -13.8% to -0.8%; p = 0.02) with ezetimibe, and intermediate-risk patients (1 to 2 biomarkers positive; n = 3,842) had an absolute risk difference of -4.4% (95% confidence interval: -9.7% to 0.8%), translating into numbers needed to treat at 7 years of 14 and 23, respectively. Low-risk patients (0 biomarkers positive; n = 1,916) did not appear to benefit from the addition of ezetimibe to statin therapy.
CONCLUSIONS


A biomarker-based strategy identifies a gradient of risk among patients post-ACS, offering the potential to identify higher-risk patients with a correspondingly high absolute benefit from the addition of ezetimibe to statin therapy.",2019,"RESULTS


Elevated levels of each biomarker were independently associated with higher risks of CV death/myocardial infarction/stroke and CV death/heart failure (p trend  < 0.001 for each).","['post-ACS patients', 'Low-risk patients (0 biomarkers positive; n\xa0=\xa01,916', 'patients with prior acute coronary syndrome (ACS', '7,195 patients stabilized (1\xa0month post-randomization) after ACS']","['ezetimibe', 'ezetimibe to statin therapy', 'ezetimibe/simvastatin versus placebo/simvastatin', 'statin therapy', 'Ezetimibe']","['risks of CV death/myocardial infarction/stroke and CV death/heart failure', 'CV death/myocardial infarction/stroke', 'risk of recurrent cardiovascular (CV) events']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C1532737', 'cui_str': 'ezetimibe / Simvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.295763,"RESULTS


Elevated levels of each biomarker were independently associated with higher risks of CV death/myocardial infarction/stroke and CV death/heart failure (p trend  < 0.001 for each).","[{'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Qamar', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/AqamarMD.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/rgiugliano.""}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Bohula', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Jeong-Gun', 'Initials': 'JG', 'LastName': 'Park', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jarolim', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Blazing', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Califf', 'Affiliation': 'Duke Forge, Duke University School of Medicine, Durham, North Carolina; Verily Life Sciences (Alphabet), South San Francisco, California; Department of Medicine, Stanford University, Stanford, California. Electronic address: https://twitter.com/califf001.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: dmorrow@bwh.harvard.edu.""}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.06.038']
3098,31377269,Effects of Methylnaltrexone on Ticagrelor-Induced Antiplatelet Effects in Coronary Artery Disease Patients Treated With Morphine.,"OBJECTIVES


The aim of this study was to assess if intravenous methylnaltrexone can counteract the effects of morphine on the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of ticagrelor.
BACKGROUND


Morphine delays the onset of action of oral P2Y 12  receptor inhibitors, including ticagrelor, by inhibiting gastric emptying and leading to delayed drug absorption. Methylnaltrexone is a peripheral opioid receptor antagonist that has the potential to prevent opioid-induced peripherally mediated side effects (e.g., gastric emptying inhibition) without affecting analgesia.
METHODS


In this prospective, randomized, double-blind, placebo-controlled, crossover study, aspirin-treated patients with stable coronary artery disease (n = 30) were randomized to receive methylnaltrexone (0.3 mg/kg intravenous) or matching placebo. After methylnaltrexone or placebo administration, all patients received morphine (5 mg intravenous). This was followed 15 min later by a 180-mg loading dose of ticagrelor. Patients crossed over to the alternative study treatment after 7 ± 2 days of washout. PK and PD assessments were performed at 12 time points (6 pre- and 6 post-crossover). PK analysis included measurement of plasma levels of ticagrelor and its major active metabolite (AR-C124910XX). PD assessments included VerifyNow P2Y 12 , light transmittance aggregometry, and vasodilator-stimulated phosphoprotein.
RESULTS


Only marginal changes in plasma levels of ticagrelor (and its major active metabolite) were observed with ticagrelor: maximum plasma concentration and area under the plasma concentration versus time curve from time 0 to the last measurable concentration were 38% and 30% higher, respectively, in patients receiving methylnaltrexone compared with those receiving placebo, but no differences in time to maximum plasma concentration were observed. There were no differences in P2Y 12  reaction units by VerifyNow P2Y 12  between groups at each time point, including 2 h (the primary endpoint; p = 0.261). Similarly, there were no differences in PD markers assessed by light transmittance aggregometry and vasodilator-stimulated phosphoprotein.
CONCLUSIONS


In patients with coronary artery disease receiving morphine, intravenous administration of the peripheral opioid receptor antagonist methylnaltrexone leads to only marginal changes in plasma levels of ticagrelor and its major metabolite, without affecting levels of platelet reactivity. (Effect of Methylnaltrexone on the PK/PD Profiles of Ticagrelor in Patients Treated With Morphine; NCT02403830).",2019,"There were no differences in P2Y 12  reaction units by VerifyNow P2Y 12  between groups at each time point, including 2 h (the primary endpoint; p = 0.261).","['Coronary Artery Disease Patients Treated With', 'treated patients with stable coronary artery disease (n\xa0= 30', 'patients with coronary artery disease receiving']","['aspirin', 'Methylnaltrexone', 'ticagrelor', 'Ticagrelor', 'methylnaltrexone or placebo', 'methylnaltrexone', 'placebo', 'methylnaltrexone (0.3\xa0mg/kg intravenous) or matching placebo', 'morphine', 'Morphine']","['VerifyNow P2Y 12 , light transmittance aggregometry, and vasodilator-stimulated phosphoprotein', 'plasma levels of ticagrelor and its major active metabolite (AR-C124910XX', 'PK and PD assessments', 'time to maximum plasma concentration', 'plasma levels of ticagrelor (and its major active metabolite', 'PD markers', 'P2Y 12  reaction units', 'pharmacokinetic (PK) and pharmacodynamic (PD) profiles']","[{'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0066411', 'cui_str': 'methylnaltrexone'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0255567', 'cui_str': 'vasodilator-stimulated phosphoprotein'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C3254492', 'cui_str': 'AR C124910XX'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",,0.16726,"There were no differences in P2Y 12  reaction units by VerifyNow P2Y 12  between groups at each time point, including 2 h (the primary endpoint; p = 0.261).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Franchi', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Rollini', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Yongwhi', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Kureti', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Rivas Rios', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Faz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Yaranov', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Latonya', 'Initials': 'L', 'LastName': 'Been', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Pineda', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Suryadevara', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Soffer', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Zenni', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Theodore A', 'Initials': 'TA', 'LastName': 'Bass', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida. Electronic address: dominick.angiolillo@jax.ufl.edu.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.05.028']
3099,32437711,Endoscopic radiofrequency ablation plus a novel oral 5-fluorouracil compound versus radiofrequency ablation alone for unresectable extrahepatic cholangiocarcinoma.,"BACKGROUND AND AIMS


Endoscopic radiofrequency ablation (RFA) is a new ablative treatment for unresectable extrahepatic cholangiocarcinoma (EHCC). A novel 5-fluorouracil compound (S-1 TM ) has been widely used as one of the key drugs with first-line or second-line chemotherapy for the treatment of advanced cholangiocarcinoma. The aim of this study is to evaluate the clinical efficacy and safety of endoscopic RFA combined with S-1 for the treatment of unresectable locally advanced EHCC.
METHODS


Patients with unresectable EHCC were prospectively randomized to 1 of 2 groups: the RFA + S-1 group and the RFA group. Median overall survival (OS), stent patency time, karnofsky performance status (KPS) score, and adverse events rate were analyzed.
RESULTS


(1) The median OS was longer in the RFA + S-1 group (n=37) than that in the RFA group (n=38) (16.0; 95% CI, 13.1-19.0 vs 11.0; 95% CI, 9.7-12.3 months; P<0.001). (2) Stent patency time was significantly longer in the RFA + S-1 group than that in the RFA group, (6.6 ± 1.5 vs 5.6 ± 0.1 months, P=0.014). (3) KPS scores at postoperative 9 months（51.6 ± 17.0 vs 40.4 ± 16.4, P=0.012, 12 months（35.2 ± 18.3 vs 23.9 ± 11.4, P=0.014） were all higher in the RFA + S-1 group than those in the RFA group (P<0.05). (4) The incidence of ERCP-related adverse events was not significantly different between RFA+S-1 group and the RFA group (8.1% vs 10.5%, P>0.05).
CONCLUSION


For the treatment of locally advanced EHCC, endoscopic RFA combined with S-1 is associated with longer survival and stent patency, and improved functional status than RFA alone.",2020,", endoscopic RFA combined with S-1 is associated with longer survival and stent patency, and improved functional status than RFA alone.","['Patients with unresectable EHCC', 'locally advanced EHCC', 'unresectable extrahepatic cholangiocarcinoma', 'unresectable extrahepatic cholangiocarcinoma (EHCC']","['Endoscopic radiofrequency ablation plus a novel oral 5-fluorouracil compound versus radiofrequency ablation alone', 'Endoscopic radiofrequency ablation (RFA', '5-fluorouracil compound (S-1 TM ', 'RFA + S-1', 'endoscopic RFA combined with S-1', 'RFA+S-1']","['Median overall survival (OS), stent patency time, karnofsky performance status (KPS) score, and adverse events rate', 'Stent patency time', 'median OS', 'functional status', 'longer survival and stent patency', 'incidence of ERCP-related adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3805278', 'cui_str': 'Extrahepatic Cholangiocarcinoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449591', 'cui_str': 'Stent patency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}]",,0.0519823,", endoscopic RFA combined with S-1 is associated with longer survival and stent patency, and improved functional status than RFA alone.","[{'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Gastroenterology, Translational Medicine Research Center, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of pharmacy, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.""}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of Gastroenterology, Translational Medicine Research Center, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.""}, {'ForeName': 'Yucheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, Nanjing Medical University, Hangzhou, Zhejiang Province, China.""}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': ""Department of Gastroenterology, Translational Medicine Research Center, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.""}, {'ForeName': 'Hangbin', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': ""Department of Gastroenterology, Translational Medicine Research Center, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.""}, {'ForeName': 'Qifeng', 'Initials': 'Q', 'LastName': 'Lou', 'Affiliation': ""Department of Gastroenterology, Translational Medicine Research Center, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.""}, {'ForeName': 'Raj J', 'Initials': 'RJ', 'LastName': 'Shah', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Colorado, American.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, Translational Medicine Research Center, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China. Electronic address: zxf837@126.com.""}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.04.075']
3100,32441736,Multiple object-tracking isolates feedback-specific load in attention and learning.,"Feedback is beneficial for learning. Nevertheless, it remains unclear whether (i) feedback draws attentional resources when integrated and (ii) the benefits of feedback for learning can be demonstrated using an attention-based task. We therefore (i) isolated feedback-specific load from task-specific load via individual differences in attention resource capacity and (ii) examined the effect of trial-by-trial feedback (i.e., present vs. absent) on learning a multiple object-tracking (MOT) paradigm. We chose MOT because it is a robust measure of attention resource capacity. In Study 1 participants tracked one (i.e., lowest attentional load condition) through four target items (i.e., highest load condition) among eight total items. One group (n = 32) received trial-by-trial feedback whereas the other group (n = 32) did not. The absence of feedback resulted in better MOT performance compared with the presence of feedback. Moreover, the difference in MOT capability between groups increased as the task-specific attentional load increased. These findings suggest that feedback integration requires attentional resources. Study 2 examined whether the absence (n = 19) or presence (n = 19) of feedback affects learning on the same MOT task across four testing days. When holding task-specific load constant, improvement in MOT was greater with feedback than without. Although this study is the first to isolate feedback-specific load in attention with MOT, more evidence is needed to demonstrate how the benefits of feedback translate to improvement on an attention-based task. These findings encourage future research to further explore the interaction between feedback, attention and learning.",2020,"When holding task-specific load constant, improvement in MOT was greater with feedback than without.",[],[],"['MOT', 'task-specific attentional load', 'MOT capability', 'MOT performance']",[],[],"[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",1.0,0.0317721,"When holding task-specific load constant, improvement in MOT was greater with feedback than without.","[{'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Tullo', 'Affiliation': ',.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Perico', 'Affiliation': ',.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Faubert', 'Affiliation': ',.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Bertone', 'Affiliation': ',.'}]",Journal of vision,['10.1167/jov.20.5.9']
3101,32441870,"Ripple Effects of a Community-Based Randomized Trial for Rural Women: Strong Hearts, Healthy Communities.","OBJECTIVE


This study aimed to examine (1) whether the Strong Hearts, Healthy Communities intervention (SHHC) improved social network members' (SNMs') weight, exercise, and diet and (2) whether SNMs' weight and behavioral changes were modified by their relationship closeness and/or spatial closeness with trial participants.
METHODS


Eight towns received the SHHC intervention, which focused on building individual healthy behaviors and creating supportive social and built environments for exercise and healthy eating. Eight towns received an education-only control intervention. SNMs (n = 487) were recruited to complete a questionnaire at baseline and at 6 months that asked about demographics, weight, height, exercise, and eating habits.
RESULTS


SHHC's effect on SNMs differed depending on their relationship closeness with trial participants. Among SNMs who had a very close relationship with trial participants, those associated with the intervention group lost more weight and decreased BMI more than those associated with the control group (weight [kilograms] between-group difference: Δ = -1.68; 95% CI: -3.10 to -0.25; P = 0.021; BMI between-group difference: Δ = -0.60; 95% CI: -1.16 to -0.04; P = 0.034). Spatial closeness did not modify any of SHHC's ripple effects.
CONCLUSIONS


Relationship closeness, rather than spatial closeness, played an important role in influencing a rural community-based intervention's ripple effects.",2020,"Spatial closeness did not modify any of SHHC's ripple effects.
","['Rural Women: Strong Hearts, Healthy Communities', 'SNMs (n\xa0=\xa0487', 'Eight towns received the']","['SHHC intervention, which focused on building individual healthy behaviors and creating supportive social and built environments for exercise and healthy eating', ""Strong Hearts, Healthy Communities intervention (SHHC) improved social network members' (SNMs') weight, exercise, and diet and (2) whether SNMs' weight"", 'education-only control intervention']",['weight and decreased BMI'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}]","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4505382', 'cui_str': 'Built Environment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}]",487.0,0.0803002,"Spatial closeness did not modify any of SHHC's ripple effects.
","[{'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Lo', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Graham', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Galen', 'Initials': 'G', 'LastName': 'Eldridge', 'Affiliation': 'Texas A&M AgriLife Research, Texas A&M University, College Station, Texas, USA.'}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Donoso', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Folta', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Strogatz', 'Affiliation': 'Bassett Research Institute, Bassett Healthcare Network, Cooperstown, New York, USA.'}, {'ForeName': 'Miriam E', 'Initials': 'ME', 'LastName': 'Nelson', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'Lynn C', 'Initials': 'LC', 'LastName': 'Paul', 'Affiliation': 'College of Education, Health and Human Development, Montana State University, Bozeman, Montana, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Parry', 'Affiliation': 'Cornell Statistical Consulting Unit, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Seguin-Fowler', 'Affiliation': 'Texas A&M AgriLife Research, Texas A&M University, College Station, Texas, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22817']
3102,32437192,Caffeine enhances sustained attention among adolescents.,"Despite the growing interest in caffeine use and its effects among adolescents, and a large literature on caffeine and attention among adults, there is a lack of experimental work examining the impact of caffeine on sustained attention among adolescents. We evaluated the acute effects of caffeine (vs. placebo) during a long (33-min) classic vigilance task among 31 adolescents (aged 12-17; 15 female; median caffeine use = 28 mg/day). We predicted a dose-dependent effect of caffeine, which would attenuate declines in target detection over time (i.e., a vigilance decrement). In each of 3 visits, participants completed an identical pairs continuous performance task beginning ∼25 min after consumption of noncaloric flavored water containing placebo, 1 mg/kg, or 3 mg/kg caffeine (order counterbalanced). Percent hits for low probability targets across 12 100-trial blocks was the primary outcome measure. As predicted, the linear decline in hits across trial blocks was attenuated by caffeine (Caffeine vs. Placebo × Block Linear,  p  = .01), with significant improvements in Blocks 9-12 ( p s < .03). Compared to 1 mg/kg, 3 mg/kg caffeine resulted in earlier improvement in target detection (Drug Dose × Block Quadratic,  p  = .001). This study demonstrated that caffeine acutely and dose-dependently improves sustained attention among adolescents. These results were likely due to the attention-enhancing effect of caffeine, rather than withdrawal reversal, as our sample was characterized by light to moderate caffeine use. This study provides the foundation for further work on the impact of chronic caffeine consumption on cognitive function during adolescence. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"As predicted, the linear decline in hits across trial blocks was attenuated by caffeine (Caffeine vs. Placebo × Block Linear,  p  = .01), with significant improvements in Blocks 9-12 ( p s < .03).","['31 adolescents (aged 12-17; 15 female; median caffeine use = 28 mg/day', 'adolescents']","['caffeine (vs. placebo', 'placebo, 1 mg/kg, or 3 mg/kg caffeine', 'caffeine', 'Caffeine', 'chronic caffeine consumption', 'caffeine (Caffeine vs. Placebo']",['target detection'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0303444', 'cui_str': 'Magnesium-28'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",,0.205251,"As predicted, the linear decline in hits across trial blocks was attenuated by caffeine (Caffeine vs. Placebo × Block Linear,  p  = .01), with significant improvements in Blocks 9-12 ( p s < .03).","[{'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Schuyler C', 'Initials': 'SC', 'LastName': 'Lawson', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Tonkin', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Ziegler', 'Affiliation': 'Department of Exercise and Nutrition Sciences.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Temple', 'Affiliation': 'Department of Exercise and Nutrition Sciences.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Hawk', 'Affiliation': 'Department of Psychology.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000364']
3103,32437229,Prognostic selection and long-term survival analysis to assess overdiagnosis risk in lung cancer screening randomized trials.,"OBJECTIVES


Overdiagnosis in low-dose computed tomography randomized screening trials varies from 0 to 67%. The National Lung Screening Trial (extended follow-up) and ITALUNG (Italian Lung Cancer Screening Trial) have reported cumulative incidence estimates at long-term follow-up showing low or no overdiagnosis. The Danish Lung Cancer Screening Trial attributed the high overdiagnosis estimate to a likely selection for risk of the active arm. Here, we applied a method already used in benefit and overdiagnosis assessments to compute the long-term survival rates in the ITALUNG arms in order to confirm incidence-excess method assessment.
METHODS


Subjects in the active arm were invited for four screening rounds, while controls were in usual care. Follow-up was extended to 11.3 years. Kaplan-Meyer 5- and 10-year survivals of ""resected and early"" (stage I or II and resected) and ""unresected or late"" (stage III or IV or not resected or unclassified) lung cancer cases were compared between arms.
RESULTS


The updated ITALUNG control arm cumulative incidence rate was lower than in the active arm, but this was not statistically significant (RR: 0.89; 95% CI: 0.67-1.18). A compensatory drop of late cases was observed after baseline screening. The proportion of ""resected and early"" cases was 38% and 19%, in the active and control arms, respectively. The 10-year survival rates were 64% and 60% in the active and control arms, respectively ( p  = 0.689). The five-year survival rates for ""unresected or late"" cases were 10% and 7% in the active and control arms, respectively ( p  = 0.679).
CONCLUSIONS


This long-term survival analysis, by prognostic categories, concluded against the long-term risk of overdiagnosis and contributed to revealing  how  screening works.",2020,"The updated ITALUNG control arm cumulative incidence rate was lower than in the active arm, but this was not statistically significant (RR: 0.89; 95% CI: 0.67-1.18).","['Subjects in the active arm were invited for four screening rounds, while controls were in usual care']",[],"['Kaplan-Meyer 5- and 10-year survivals of ""resected and early"" (stage I or II and resected) and ""unresected or late', 'cumulative incidence rate', 'five-year survival rates', 'proportion of ""resected and early"" cases', '10-year survival rates']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",,0.241633,"The updated ITALUNG control arm cumulative incidence rate was lower than in the active arm, but this was not statistically significant (RR: 0.89; 95% CI: 0.67-1.18).","[{'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Paci', 'Affiliation': 'Formerly Clinical Epidemiology Unit, ISPRO - Oncological Network, Prevention and Research Institute Oncological Network, Prevention and Research Institute, Florence, Italy.'}, {'ForeName': 'Donella', 'Initials': 'D', 'LastName': 'Puliti', 'Affiliation': 'Clinical Epidemiology Unit, ISPRO - Oncological network, prevention and research institute, Florence, Italy.'}, {'ForeName': 'Francesca Maria', 'Initials': 'FM', 'LastName': 'Carozzi', 'Affiliation': 'Regional Prevention Laboratory Unit, ISPRO - Oncological Network, Prevention and Research Institute, Florence, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Carrozzi', 'Affiliation': 'Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Falaschi', 'Affiliation': 'Radiology Department, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Andrea Lopes', 'Initials': 'AL', 'LastName': 'Pegna', 'Affiliation': 'Formerly Pneumonology Department, Careggi Hospital, Florence, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mascalchi', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences ""Mario Serio"", University of Florence, Florence, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Picozzi', 'Affiliation': 'Radiodiagnostic Unit, ISPRO - Oncological Network, Prevention and Research Institute, Florence, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pistelli', 'Affiliation': 'Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zappa', 'Affiliation': 'Clinical Epidemiology Unit, ISPRO - Oncological network, prevention and research institute, Florence, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of medical screening,['10.1177/0969141320923030']
3104,31415306,"Maternal Depressive Symptoms and Perceived Picky Eating in a Low-Income, Primarily Hispanic Sample.","OBJECTIVE


Feeding concerns are common in the first 2 years of life and typically reflect maternal perceptions occurring within the larger context of the parent-child relationship. We aimed to determine whether (1) maternal depressive systems predicted perceived picky eating, mediated by maternal negative perceptions; (2) receipt of the Video Interaction Project (VIP) parenting intervention impacted perceived picky eating through this pathway; and (3) perceived picky eating was associated with child growth or subsequent dietary patterns.
METHODS


We performed a partial longitudinal analysis of 187 low-income, predominantly Hispanic mother-child dyads enrolled in a randomized controlled trial of the VIP. Mother-infant dyads were enrolled postpartum in an urban public hospital. Participants randomized to the VIP met with an interventionist on days of well-child visits; sessions were designed to facilitate interactions in play and shared reading through provision of learning materials and review of videotaped parent-child interaction; the curriculum did not contain feeding-specific elements. We used structural equation modeling to determine direct, indirect, and total effects of maternal depressive symptoms, maternal negative perceptions, and the VIP on perceived picky eating. We then tested associations between perceived picky eating and (1) child growth, using multivariable linear regression and multilevel modeling; and (2) subsequent child dietary consumption, using multivariable multinomial logistic regression.
RESULTS


Maternal depressive symptoms had significant total effects on negative maternal perceptions (β = 0.32, p < 0.001) and perceived picky eating (β = 0.21, p < 0.01) after controlling for potential confounders. This effect was partially mediated by maternal negative perceptions (indirect effect: β = 0.06, p = 0.04). When used in the model as the predictor, the VIP had a significant total effect on perceived picky eating (β = -0.16, p = 0.02), which was partially mediated by maternal depressive symptoms and negative perceptions (indirect effect: β = -0.05, p = 0.02). Perceived picky eating was not associated with child diet at age 2 years or adiposity from 6 months to 3 years.
CONCLUSION


Maternal concerns about picky eating may reflect deeper depressive symptoms and negative perceptions of her child's behavior. Interventions designed to facilitate positive parenting in general may lessen feeding-specific concerns, such as picky eating. Although reassurance about growth and nutritional outcomes for children perceived as picky eaters is appropriate, clinicians should also consider probing for underlying symptoms of depression that could lead to eating concerns.",2019,"RESULTS


Maternal depressive symptoms had significant total effects on negative maternal perceptions (β = 0.32, p < 0.001) and perceived picky eating (β = 0.21, p < 0.01) after controlling for potential confounders.","['Mother-infant dyads were enrolled postpartum in an urban public hospital', '187 low-income, predominantly Hispanic mother-child dyads enrolled']",['Video Interaction Project (VIP) parenting intervention impacted perceived picky eating through this pathway; and (3) perceived picky eating was associated with child growth or subsequent dietary patterns'],"['Perceived picky eating', 'Maternal Depressive Symptoms and Perceived Picky Eating', 'negative maternal perceptions', 'maternal depressive symptoms and negative perceptions', 'perceived picky eating']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",187.0,0.0759602,"RESULTS


Maternal depressive symptoms had significant total effects on negative maternal perceptions (β = 0.32, p < 0.001) and perceived picky eating (β = 0.21, p < 0.01) after controlling for potential confounders.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Katzow', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Canfield', 'Affiliation': 'Division of Developmental-Behavioral Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Gross', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Messito', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Carolyn Brockmeyer', 'Initials': 'CB', 'LastName': 'Cates', 'Affiliation': 'Department of Psychology, State University of New York at Purchase, Harrison, NY.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Weisleder', 'Affiliation': 'Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL.'}, {'ForeName': 'Samantha Berkule', 'Initials': 'SB', 'LastName': 'Johnson', 'Affiliation': 'Division of Developmental-Behavioral Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Division of Developmental-Behavioral Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000715']
3105,32441811,Effect of supportive care on the psychosocial health status of women who had a miscarriage.,"PURPOSE


This study aims to determine the effect of individualized care provided based on Swanson's Caring Theory on the grief, depression, anxiety, and stress levels of women who had a miscarriage.
DESIGN AND METHODS


A total of 104 women who experienced a miscarriage were randomized as study (n = 52) and control (n = 52) groups.
FINDINGS


The women's physical, emotional, behavioral, and cognitive grief symptoms decreased after receiving Swanson's care (P < .001). Negative feelings about the future, level of depression, and anxiety levels diminished after receiving Swanson's Care (P < .001).
PRACTICE IMPLICATIONS


Supportive care and counseling provided after miscarriage were found to contribute to women's psychosocial well-being and to improve their ability to cope with psychological symptoms.",2020,"Negative feelings about the future, level of depression, and anxiety levels diminished after receiving Swanson's Care (P < .001).
","['women who had a miscarriage', '104 women who experienced a miscarriage were randomized as study (n\u2009=\u200952) and control (n\u2009=\u200952) groups']",['supportive care'],"['Negative feelings about the future, level of depression, and anxiety levels', 'grief, depression, anxiety, and stress levels', 'psychosocial health status', 'emotional, behavioral, and cognitive grief symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",104.0,0.028086,"Negative feelings about the future, level of depression, and anxiety levels diminished after receiving Swanson's Care (P < .001).
","[{'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Palas Karaca', 'Affiliation': 'Department of Midwifery, Faculty of Health Sciences, Balıkesir University, Balıkesir, Turkey.'}, {'ForeName': 'Ümran Yeşiltepe', 'Initials': 'ÜY', 'LastName': 'Oskay', 'Affiliation': 'Department of Obstetrics and Gynecologic Nursing, Florence Nightingale Faculty of Nursing, Istanbul University-Cerrahpasa, Istanbul, Sisli, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12540']
3106,32437921,Central review of radiation therapy planning among patients with breast-conserving surgery: results from a quality assurance process integrated into the INSEMA trial.,"PURPOSE


After publication of the radiation field design in the ACOSOG Z0011 trial, a radiotherapy quality assurance review was integrated into the XXX trial. We aimed to investigate the role of patient characteristics, extent of axillary surgery, and radiation techniques for dose distribution in ipsilateral axillary levels.
PATIENTS AND METHODS


XXX has randomized 5,542 patients with breast-conserving surgery. Of these, 276 patients from 108 radiotherapy facilities were included in the central review using the planning records of the first three patients treated at each site.
RESULTS


Of the 276 patients, 41 had major deviations (i.e., no axillary contouring or submission of insufficient records) leading to exclusion. 235 (85.1%) radiotherapy planning records were delineated according to the XXX protocol, including 9 (3.8%) cases with minor deviations. At least 25% of XXX patients were unintentionally treated with ≥95% of the prescribed breast radiation dose in axillary level I. Approximately 50% of patients were irradiated with a median radiation dose of more than 85% of prescription dose in level I. Irradiated volumes and applied doses were significantly lower in level II and III when compared to level I. However, 25% of patients still received a median radiation dose of ≥75% of prescription dose to level II. Subgroup analysis revealed a significant association between incidental radiation dose in the axilla and obesity. Younger age, boost application, and fractionation schedule showed no impact on axillary dose distribution.
CONCLUSIONS


Assuming ≥80% of prescribed breast dose as the optimal dose for curative radiation of low-volume disease in axillary lymph nodes, at least 50% of reviewed XXX patients received an adequate dose in level I, even with contemporary 3D techniques. Dose coverage was much less in axillary levels II and III, and far below therapeutically relevant doses.",2020,"Younger age, boost application, and fractionation schedule showed no impact on axillary dose distribution.
","['axillary lymph nodes', '5,542 patients with breast-conserving surgery', '276 patients', '276 patients from 108 radiotherapy facilities were included in the central review using the planning records of the first three patients treated at each site', 'patients with breast-conserving surgery']","['radiation therapy planning', 'XXX']",[],"[{'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]",[],5542.0,0.0393912,"Younger age, boost application, and fractionation schedule showed no impact on axillary dose distribution.
","[{'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Radiotherapy, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Angrit', 'Initials': 'A', 'LastName': 'Stachs', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'Potenberg', 'Affiliation': 'Breast Center, Evangelisches Waldkrankenhaus Spandau, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Department of Radiation Oncology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Kathi', 'Initials': 'K', 'LastName': 'Wolter', 'Affiliation': 'Department of Radiotherapy, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Kühn', 'Affiliation': 'Department of Obstetrics and Gynecology, Interdisciplinary Breast Center, Esslingen, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Zierhut', 'Affiliation': 'Department of Radio-Oncology and Radiotherapy, Klinikum Hanau GmbH, Hanau, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Sedlmayer', 'Affiliation': 'Department of Radiotherapy and Radio-Oncology, LKH Salzburg, Paracelsus Medical University Clinics, Salzburg, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kaiser', 'Affiliation': 'Department of Radiotherapy and Radio-Oncology, LKH Salzburg, Paracelsus Medical University Clinics, Salzburg, Austria.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Reitsamer', 'Affiliation': 'Breast Center, LKH Salzburg, Paracelsus Medical University Clinics, Salzburg, Austria.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Heil', 'Affiliation': 'Breast Unit, University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Bekes', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Toralf', 'Initials': 'T', 'LastName': 'Reimer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany. Electronic address: toralf.reimer@med.uni-rostock.de.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.04.042']
3107,32441852,Effectiveness and Safety of Fast Enteral Advancement In Preterm Infants Between 1000 and 2000 g of Birth Weight.,"BACKGROUND


The advancement of enteral nutrition in premature infants is still controversial. It is necessary to provide an adequate caloric intake avoiding feeding intolerance and necrotizing enterocolitis (NEC).
OBJECTIVE


To establish the safety and effectiveness of fast enteral advancement comparing it with the traditional advancement.
MATERIALS AND METHODS


Controlled randomized clinical trial. Advancement of 30 cc vs. 20 cc/kg/day in premature infants under 34 weeks, between 1000 and 1499 g birth weight and 40 cc vs. 20 cc/kg/day in those from 1500 to 1999 g.
OUTCOMES


time to reach total enteral nutrition, days of parenteral nutrition and/or intravenous fluids, days to recover birth weight, episodes of feeding intolerance, growth and weight gain at 40 weeks, sepsis, hypoglycaemia, hyperbilirubinemia, NEC and mortality. Student's t-test or Mann-Whitney U test, Fisher's test or χ 2  test and multiple linear regression were used.
RESULTS


Differences were found in both days to reach the total enteral nutrition (slow: 7 (PC 25-75: 6-9), fast: 4 (PC 25-75: 4-6) P < 0.001) and days of IVF or PN (slow: 6 (PC 25-75 4-8), fast: 3 (PC 25-75 3-5) P < 0.001). Fast advancement decreases time to total enteral nutrition by 3 days and the need for PN and/or IVF by up to 5 days. There were no differences in feeding intolerance episodes or other outcomes.
CONCLUSION


Fast enteral advancement decreases the days to reach total enteral nutrition and the days of PN and/or IVF without causing greater feeding intolerance. Additional studies are required to obtain more evidence. This article is protected by copyright. All rights reserved.",2020,"There were no differences in feeding intolerance episodes or other outcomes.
","['Preterm Infants Between 1000 and 2000 g of Birth Weight', 'premature infants']",['Fast Enteral Advancement'],"['days of IVF or PN', 'Effectiveness and Safety', 'time to reach total enteral nutrition, days of parenteral nutrition and/or intravenous fluids, days to recover birth weight, episodes of feeding intolerance, growth and weight gain at 40 weeks, sepsis, hypoglycaemia, hyperbilirubinemia, NEC and mortality', 'feeding intolerance episodes', 'total enteral nutrition']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}]",,0.0922506,"There were no differences in feeding intolerance episodes or other outcomes.
","[{'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Del PilarMontealegre-Pomar', 'Affiliation': 'Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Bogotá, Colombia, South America.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Bertolotto-Cepeda', 'Affiliation': 'Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Bogotá, Colombia, South America.'}, {'ForeName': 'Yoliseth', 'Initials': 'Y', 'LastName': 'Romero-Marquez', 'Affiliation': 'Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Bogotá, Colombia, South America.'}, {'ForeName': 'Kelly José', 'Initials': 'KJ', 'LastName': 'Muñoz-Ramírez', 'Affiliation': 'Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Bogotá, Colombia, South America.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1925']
3108,32437187,Task demands modulate the effects of speech on text processing.,"Task-irrelevant background sound can disrupt performance of visually based cognitive tasks. The cross-modal breakdown of attentional selectivity in the context of reading was addressed using analyses of eye movements. Moreover, the study addressed whether task-sensitivity to distraction via background speech on reading was modulated by the cognitive demands of the focal task. Two randomly-assigned groups of native Chinese participants read the same set of Chinese experimental sentences while being exposed to meaningful speech, meaningless (foreign) speech, or silence. For one group, participants were instructed to judge whether the sentences made sense (i.e., semantic acceptability task); for another, participants were instructed to detect whether the sentences contained a noncharacter (i.e., noncharacter detection task). Results showed no significant effect across sound conditions for the noncharacter detection task. For the semantic acceptability task, however, there was a substantial disruptive effect of the meaningfulness of the speech. Compared with reading with meaningless speech or reading in silence, the meaningful speech increased numbers of fixations, regressions, regression path, and total reading times. These results suggest that the disruption of reading by background speech is jointly dependent on the nature of the speech and the task process deployed, thereby favoring an Interference-by-Process account over Interference-by-Content and Attentional Diversion accounts of distraction to reading by background sound. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Results showed no significant effect across sound conditions for the noncharacter detection task.,[],"['native Chinese participants read the same set of Chinese experimental sentences while being exposed to meaningful speech, meaningless (foreign) speech, or silence']","['numbers of fixations, regressions, regression path, and total reading times']",[],"[{'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0241402,Results showed no significant effect across sound conditions for the noncharacter detection task.,"[{'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'Academy of Psychology and Behavior.'}, {'ForeName': 'Zebo', 'Initials': 'Z', 'LastName': 'Lan', 'Affiliation': 'Academy of Psychology and Behavior.'}, {'ForeName': 'Guoli', 'Initials': 'G', 'LastName': 'Yan', 'Affiliation': 'Academy of Psychology and Behavior.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Marsh', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Liversedge', 'Affiliation': 'School of Psychology.'}]","Journal of experimental psychology. Learning, memory, and cognition",['10.1037/xlm0000861']
3109,31366262,Treatment preference for weekly versus daily DPP-4 inhibitors in patients with type 2 diabetes mellitus: outcomes from the TRINITY trial.,"Objective:  To examine patient preference for treatment with the oral once-weekly dipeptidyl peptidase-4 inhibitor (DPP-4i), trelagliptin, and oral once-daily DPP-4i, alogliptin, administered for 8 weeks each in patients with type 2 diabetes mellitus prescribed a daily DPP-4i. Methods:  In this randomized, open-label, two-way crossover study, patients received trelagliptin followed by alogliptin (T-A group) or alogliptin followed by trelagliptin (A-T group), for 8 weeks each (NCT03231709, JapicCTI-173662). Treatment preference was assessed using a standardized questionnaire in the overall population and by baseline characteristics. Other outcomes included patient satisfaction with diabetes treatment (assessed using the Diabetes Treatment Satisfaction Questionnaire [DTSQ]), hemoglobin A1c (HbA1c) levels after 8 weeks of treatment with each agent, and safety. Results:  Sixty patients from two clinical sites were randomized 1:1 to T-A and A-T groups (each  n  = 30); baseline characteristics were similar between groups. After 16 weeks of treatment, 51.7% of patients preferred treatment with alogliptin compared with 30.0% selecting trelagliptin ( p  = .014); preference for alogliptin was consistently greater than for trelagliptin in the secondary analyses by baseline characteristics. DTSQ score and HbA1c levels were similar between treatments after 8 weeks of therapy. Both treatments demonstrated favorable safety and tolerability profiles. Conclusions:  Patients expressed a significantly greater treatment preference for once-daily alogliptin than once-weekly trelagliptin, although patient satisfaction and HbA1c levels were similar across treatments. The decision to administer a once-weekly or once-daily DPP-4i is likely to depend on patient preference, patient-physician discussions, and treatment practices of the prescribing physician.",2019,"Patients expressed a significantly greater treatment preference for once-daily alogliptin than once-weekly trelagliptin, although patient satisfaction and HbA1c levels were similar across treatments.","['patients with type 2 diabetes mellitus', 'Sixty patients from two clinical sites', 'patients with type 2 diabetes mellitus prescribed a daily DPP-4i']","['alogliptin', 'dipeptidyl peptidase-4 inhibitor (DPP-4i), trelagliptin, and oral once-daily DPP-4i, alogliptin', 'DPP-4 inhibitors', 'trelagliptin followed by alogliptin (T-A group) or alogliptin followed by trelagliptin']","['favorable safety and tolerability profiles', 'DTSQ score and HbA1c levels', 'patient satisfaction with diabetes treatment (assessed using the Diabetes Treatment Satisfaction Questionnaire [DTSQ]), hemoglobin A1c (HbA1c) levels', 'preference for alogliptin', 'safety', 'patient satisfaction and HbA1c levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}]","[{'cui': 'C1958126', 'cui_str': 'alogliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C4045234', 'cui_str': 'trelagliptin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451116', 'cui_str': 'Diabetes treatment satisfaction questionnaire (assessment scale)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C1958126', 'cui_str': 'alogliptin'}]",60.0,0.142705,"Patients expressed a significantly greater treatment preference for once-daily alogliptin than once-weekly trelagliptin, although patient satisfaction and HbA1c levels were similar across treatments.","[{'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Meguro', 'Affiliation': 'Department of Nephrology, Endocrinology and Metabolism, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': 'Japan Medical Affairs, Takeda Pharmaceutical Company Limited, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Department of Nephrology, Endocrinology and Metabolism, Keio University School of Medicine, Tokyo, Japan.'}]",Current medical research and opinion,['10.1080/03007995.2019.1651130']
3110,32441709,Evaluation of the effect of endoscopic partial middleturbinectomy surgery on the quality of life of patients with chronic rhinosinusitis and nasal polyps.,"BACKGROUND


Chronic rhinosinusitis (CRS) is a common chronic inflammatory disease. Endoscopic sinus surgery is recommended as a standard method when medical treatment fails. The effectiveness of various complementary surgical methods such as endoscopic partial middle-turbinectomy is controversial in the improvement of CRS symptoms in these patients. This study aimed to investigate the effect of endoscopic partial middle-turbinectomy on the quality of life (QOL) of patients with chronic rhinosinusitis and nasal polyps (CRSwNP) in Iran.
METHOD


Ninety patients with CRSwNP of grades 3 and 4 were randomly assigned to either an intervention (45 patients) or control group (45 patients). In the control group, endoscopic sinus surgery without middle turbinectomy was performed and in the intervention group, endoscopic partial middle-turbinectomy was performed in addition to endoscopic sinus surgery. To evaluate the outcomes, the SNOT-22 QOL questionnaire was used, and the results were analyzed using SPSS version 24.
RESULTS


Most of the patients were male and had a mean age of 39 years. The mean SNOT-22 QOL questionnaire scores were 49.13±16.72 and 52.51±16.95 before surgery in the control and intervention groups respectively, which did not show any significant difference. In contrast, after endoscopic surgery these scores changed to 28.46±12.38 and 11.13±5.55 in the control and intervention groups, respectively&lt; and there was a significant difference between both groups. Although there was a significant improvement in both groups, the patients in the intervention group experienced more improvement than the control group (41.4 (±16.46) vs 30.7 (±18.27), respectively CONCLUSION: According to this study, it appears that the use of endoscopic partial middle-turbinectomy in addition to endoscopic sinus surgery improves CRS symptoms and the QOL of patients compared with endoscopic sinus surgery alone.",2020,"Although there was a significant improvement in both groups, the patients in the intervention group experienced more improvement than the control group (41.4 (±16.46) vs 30.7 (±18.27), respectively CONCLUSION:","['patients with chronic rhinosinusitis and nasal polyps (CRSwNP) in Iran', 'patients were male and had a mean age of 39 years', 'patients with chronic rhinosinusitis and nasal polyps', 'Chronic rhinosinusitis (CRS', 'Ninety patients with CRSwNP of grades 3 and 4']","['endoscopic partial middleturbinectomy surgery', 'endoscopic partial middle-turbinectomy was performed in addition to endoscopic sinus surgery', 'Endoscopic sinus surgery', 'endoscopic partial middle-turbinectomy', 'endoscopic sinus surgery without middle turbinectomy']","['quality of life', 'mean SNOT-22 QOL questionnaire scores', 'quality of life (QOL', 'SNOT-22 QOL questionnaire', 'CRS symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0161872', 'cui_str': 'Turbinectomy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",90.0,0.0323866,"Although there was a significant improvement in both groups, the patients in the intervention group experienced more improvement than the control group (41.4 (±16.46) vs 30.7 (±18.27), respectively CONCLUSION:","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Delarestaghi', 'Affiliation': 'Firoozgar Clinical Research Development Center, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rajaeih', 'Affiliation': 'Firoozgar Clinical Research Development Center, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'F D', 'Initials': 'FD', 'LastName': 'Firouzabadi', 'Affiliation': 'ENT and Head and Neck Research Center, The Five Senses Institute, Hazrat Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jamali', 'Affiliation': 'ENT and Head and Neck Research Center, The Five Senses Institute, Hazrat Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roomiani', 'Affiliation': 'ENT and Head and Neck Research Center, The Five Senses Institute, Hazrat Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Firouzabadi', 'Affiliation': 'ENT and Head and Neck Research Center, The Five Senses Institute, Hazrat Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Memari', 'Affiliation': 'Firoozgar Clinical Research Development Center, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jahandideh', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}]",Rhinology,['10.4193/Rhin19.258']
3111,32441857,Benefit of buspirone on chemoreflex and central apnoeas in heart failure: a randomized controlled crossover trial.,"AIMS


Increased chemosensitivity to carbon dioxide (CO 2  ) is an important trigger of central apnoeas (CA) in heart failure (HF), with negative impact on outcome. We hypothesized that buspirone, a 5HT 1A  receptor agonist that inhibits serotonergic chemoreceptor neuron firing in animals, can decrease CO 2  chemosensitivity and CA in HF.
METHODS AND RESULTS


The BREATH study was a randomized, double-blind, placebo-controlled, crossover study (EudraCT-code 2015-005383-42). Outpatients with systolic HF (left ventricular ejection fraction <50%) and moderate-severe CA [nocturnal apnoea-hypopnoea index (AHI) ≥15 events/h] were randomly assigned to either oral buspirone (15 mg thrice daily) or placebo for 1 week, with a crossover design (1 week of wash-out). The primary effectiveness endpoint was a decrease in CO 2  chemosensitivity >0.5 L/min/mmHg. The primary safety endpoint was freedom from serious adverse events. Sixteen patients (age 71.3 ± 5.8 years, all males, left ventricular ejection fraction 29.8 ± 7.8%) were enrolled. In the intention-to-treat analysis, more patients treated with buspirone (8/16, 50%) had a CO 2  chemosensitivity reduction >0.5 L/min/mmHg from baseline than those treated with placebo (1/16, 6.7%) (difference between groups 43%, 95% confidence interval 14-73%, P = 0.016). Buspirone compared to baseline led to a 41% reduction in CO 2  chemosensitivity (P = 0.001) and to a reduction in the AHI, central apnoea index and oxygen desaturation index of 42%, 79%, 77% at nighttime and 50%, 78%, 86% at daytime (all P < 0.01); no difference was observed after placebo administration (all P > 0.05). No patient reported buspirone-related serious adverse events.
CONCLUSIONS


Buspirone reduces CO 2  chemosensitivity and improves CA and oxygen saturation across the 24 h in patients with HF.",2020,"Buspirone compared to baseline led to a 41% reduction in CO 2  chemosensitivity (P = 0.001) and to a reduction in the AHI, central apnoea index and oxygen desaturation index of 42%, 79%, 77% at nighttime and 50%, 78%, 86% at daytime (all P < 0.01); no difference was observed after placebo administration (all P > 0.05).","['Outpatients with systolic HF (left ventricular ejection fraction <50%) and moderate-severe CA [nocturnal apnoea-hypopnoea index (AHI)\u2009≥15\u2009events/h', 'heart failure', 'Sixteen patients (age 71.3\u2009±\u20095.8\u2009years, all males, left ventricular ejection fraction 29.8\u2009±\u20097.8%) were enrolled']","['Buspirone', 'buspirone', 'oral buspirone', 'carbon dioxide (CO 2  ', 'placebo']","['CO 2  chemosensitivity', 'CA and oxygen saturation', 'freedom from serious adverse events', 'AHI, central apnoea index and oxygen desaturation index']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}]",,0.263347,"Buspirone compared to baseline led to a 41% reduction in CO 2  chemosensitivity (P = 0.001) and to a reduction in the AHI, central apnoea index and oxygen desaturation index of 42%, 79%, 77% at nighttime and 50%, 78%, 86% at daytime (all P < 0.01); no difference was observed after placebo administration (all P > 0.05).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Giannoni', 'Affiliation': 'Fondazione Toscana G. Monasterio, Pisa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Borrelli', 'Affiliation': 'Fondazione Toscana G. Monasterio, Pisa, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Mirizzi', 'Affiliation': 'Fondazione Toscana G. Monasterio, Pisa, Italy.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Richerson', 'Affiliation': 'Department of Neurology, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Emdin', 'Affiliation': 'Fondazione Toscana G. Monasterio, Pisa, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Passino', 'Affiliation': 'Fondazione Toscana G. Monasterio, Pisa, Italy.'}]",European journal of heart failure,['10.1002/ejhf.1854']
3112,31434111,A Placebo-Controlled Double-Blind Randomized Trial with Individualized Homeopathic Treatment Using a Symptom Cluster Approach in Women with Premenstrual Syndrome.,"BACKGROUND


In a double-blind placebo-controlled randomized trial with parallel groups, the efficacy of individually prescribed homeopathic medicines was evaluated in women with premenstrual syndrome (PMS).
METHODS


In an outpatient department of a university clinic in Jerusalem, Israel (1996-1999), women with PMS, aged 18 to 50 years, entered a 2-month screening phase with prospective daily recording of premenstrual symptoms by the Menstrual Distress Questionnaire (MDQ). They were included after being diagnosed with PMS. A reproducible treatment protocol was used: women received a homeopathic prescription based on symptom clusters identified in a questionnaire. The symptoms were verified during a complementary, structured, interview. Only women whose symptoms matched the symptom profile of one of 14 pre-selected homeopathic medicines were included. Each participant was administered active medicine or placebo via random allocation. Primary outcome measures were differences in changes in mean daily premenstrual symptom (PM) scores by the MDQ. Analysis was by intention-to-treat.
RESULTS


A total of 105 women were included: 49 were randomized to active medicine and 56 to placebo. Forty-three women in the active medicine group and 53 in the placebo group received the allocated intervention with at least one follow-up measurement and their data were analyzed. Significantly greater improvement of mean PM scores was measured in the active medicine group (0.443 [standard deviation, SD, 0.32] to 0.287 [SD, 0.20]) compared to placebo (0.426 [SD, 0.34] to 0.340 [SD, 0.39]);  p  = 0.043.
CONCLUSIONS


Individually prescribed homeopathic medicines were associated with significantly greater improvement of PM scores in women with PMS, compared to placebo. Replication, with larger sample size and other refinements, is recommended to confirm the efficacy of this treatment in other settings.",2019,"CONCLUSIONS


Individually prescribed homeopathic medicines were associated with significantly greater improvement of PM scores in women with PMS, compared to placebo.","['Only women whose symptoms matched the symptom profile of one of 14 pre-selected homeopathic medicines were included', 'Women with Premenstrual Syndrome', 'Forty-three women in the active medicine group and 53 in the', 'A total of 105 women were included: 49', 'In an outpatient department of a university clinic in Jerusalem, Israel (1996-1999), women with PMS, aged 18 to 50 years, entered a 2-month screening phase with prospective daily recording of premenstrual symptoms by the Menstrual Distress Questionnaire (MDQ', 'women with premenstrual syndrome (PMS']","['homeopathic medicines', 'Individualized Homeopathic Treatment', 'active medicine and 56 to placebo', 'placebo', 'Placebo', 'homeopathic prescription', 'active medicine or placebo']","['PM scores', 'mean daily premenstrual symptom (PM) scores', 'mean PM scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic Remedies'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0232959', 'cui_str': 'Symptom occurs premenstrually (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0920324', 'cui_str': 'Homeopathic Remedies'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0232959', 'cui_str': 'Symptom occurs premenstrually (finding)'}]",43.0,0.738947,"CONCLUSIONS


Individually prescribed homeopathic medicines were associated with significantly greater improvement of PM scores in women with PMS, compared to placebo.","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Yakir', 'Affiliation': 'Israeli Association for Classical Homeopathy, Tel Aviv, Israel.'}, {'ForeName': 'Christien T', 'Initials': 'CT', 'LastName': 'Klein-Laansma', 'Affiliation': 'Louis Bolk Institute, Health and Nutrition, Bunnik, The Netherlands.'}, {'ForeName': 'Shulamith', 'Initials': 'S', 'LastName': 'Kreitler', 'Affiliation': 'Psycho-oncology Research Center, Sheba Medical Center, Tel HaShomer, Israel.'}, {'ForeName': 'Amnon', 'Initials': 'A', 'LastName': 'Brzezinski', 'Affiliation': 'Hadassah University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Menachem', 'Initials': 'M', 'LastName': 'Oberbaum', 'Affiliation': 'The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Vithoulkas', 'Affiliation': 'International Homeopathic Academy, Allonisos, Greece.'}, {'ForeName': 'Zvi', 'Initials': 'Z', 'LastName': 'Bentwich', 'Affiliation': 'Rosetta Genomics, Rehovot, Israel.'}]",Homeopathy : the journal of the Faculty of Homeopathy,['10.1055/s-0039-1691834']
3113,32437328,Physical activity with tailored mHealth support for individuals with intellectual disabilities: study protocol for a randomized controlled trial.,"BACKGROUND


Individuals with intellectual disabilities (IDs) have lower levels of physical activity (PA) and greater barriers for participation in fitness activities, compared with members of the general population. As increased PA has positive effects on cardiovascular and psychosocial health, it is exceedingly important to identify effective interventions for use in everyday settings. mHealth methods such as motion sensor games (exergames) and smartphone reminders for PA have been explored and found to be promising in individuals with IDs.
OBJECTIVE


The purpose of this study is to examine the effectiveness of an individually tailored PA program with motivational mHealth support on daily levels of PA in youth and adults with IDs.
METHODS


The trial uses a randomized controlled design comprising 30 intervention participants and 30 controls, aged 16 to 60 years, with a sedentary lifestyle or low PA level. While the controls will receive standard care, the intervention aims to increase the level of PA in terms of objectively measured steps per day, body mass index, blood pressure, physical performance, social support for PA, self-efficacy in PA setting, behavior problems and goal attainment as secondary outcome variables. Using tailored mHealth support and smartphones or tablets to create structure, the intervention will focus on the communicative abilities of individual participants, using rewards and providing feedback, in order to motivate individuals to increase participation in PA. Participants in the intervention group, their close relatives, and care staff will be invited to participate in a preintervention goal-setting meeting on PA during the intervention period where Goal Attainment Scaling will be used to select the participants' PA goals for the intervention. All participants will be assessed at baseline, 3 months, and 6 months, respectively.
RESULTS


The main contribution of this paper is a detailed plan for how to run our study that will produce new knowledge about the relation between mHealth support, physical activities, and individuals with intellectual disabilities.
CONCLUSIONS


We expect the new intervention to perform better than standard care in terms of improved PA, improved self-efficacy and social support for activities. Technology offers new opportunities to promote healthy behaviors. The results of the study will determine the effectiveness and sustainability of a tailored mHealth support intervention to increase PA in youth and adults with IDs.
CLINICALTRIAL


The trial is registered at ClinicalTrials.gov with the identifier number HNF1353-17.",2020,"We expect the new intervention to perform better than standard care in terms of improved PA, improved self-efficacy and social support for activities.","['30 intervention participants and 30 controls, aged 16 to 60 years, with a sedentary lifestyle or low PA level', 'individuals with IDs', 'youth and adults with IDs', 'individuals with intellectual disabilities', 'Individuals with intellectual disabilities (IDs']",[],"['Physical activity', 'blood pressure, physical performance, social support for PA, self-efficacy in PA setting, behavior problems and goal attainment']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",30.0,0.0665167,"We expect the new intervention to perform better than standard care in terms of improved PA, improved self-efficacy and social support for activities.","[{'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Michalsen', 'Affiliation': 'Department of Rehabilitation, REFF, University Hospital of North Norway, Hansine Hansens vei 67, Tromsø, NO.'}, {'ForeName': 'Silje Camilla', 'Initials': 'SC', 'LastName': 'Wangberg', 'Affiliation': 'Department of Health and Care Sciences, UiT The Arctic University of Norway, Narvik, NO.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Hartvigsen', 'Affiliation': 'Department of Computer Science, UiT The Artic University of Norway, Tromsø, NO.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Jaccheri', 'Affiliation': 'Department of Computer Science, NTNU, Trondheim, NO.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Muzny', 'Affiliation': 'Department of Rehabilitation, REFF, University Hospital of North Norway, Hansine Hansens vei 67, Tromsø, NO.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Henriksen', 'Affiliation': 'Department of Community Medicine, UiT The Arctic University of Norway, Tromsø, NO.'}, {'ForeName': 'Monica Isabel', 'Initials': 'MI', 'LastName': 'Olsen', 'Affiliation': 'Department of Rehabilitation, REFF, University Hospital of North Norway, Hansine Hansens vei 67, Tromsø, NO.'}, {'ForeName': 'Gyrd', 'Initials': 'G', 'LastName': 'Thrane', 'Affiliation': 'Department of Health and Care Sciences, UiT The Arctic University of Norway, Tromsø, NO.'}, {'ForeName': 'Reidun Birgitta', 'Initials': 'RB', 'LastName': 'Jahnsen', 'Affiliation': 'Department of Neurosciences for Children, Oslo University Hospital, Oslo, NO.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Pettersen', 'Affiliation': 'Department of Health and Care Sciences, UiT The Arctic University of Norway, Tromsø, NO.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Arntzen', 'Affiliation': 'Department of Health and Care Sciences, UiT The Arctic University of Norway, Narvik, NO.'}, {'ForeName': 'Audny', 'Initials': 'A', 'LastName': 'Anke', 'Affiliation': 'Department of Rehabilitation, REFF, University Hospital of North Norway, Hansine Hansens vei 67, Tromsø, NO.'}]",JMIR research protocols,['10.2196/19213']
3114,32441760,"A peer navigation intervention to prevent HIV among mixed immigrant status Latinx GBMSM and transgender women in the United States: outcomes, perspectives and implications for PrEP uptake.","The Latinx population in the United States is disproportionately affected by HIV. Our community-based participatory research partnership developed, implemented and evaluated a Spanish-language peer navigation intervention designed to increase HIV testing and condom use among social networks of immigrant Spanish-speaking Latinx gay, bisexual and other men who have sex with men (GBMSM) and transgender women (TW). We randomized 21 social networks of Latinx GBMSM and TW, ages 18-55 years, to the intervention, known as HOLA, or a waitlist control group. Social network participants (n = 166) completed structured assessments at baseline and 12-month follow-up (24 months after baseline). Follow-up retention was 95%. Individual in-depth interviews with a sample of participants documented their intervention-related experiences, needs, and priorities to inform future research. At follow-up, HOLA participants reported increased HIV testing (adjusted odds ratio = 8.3; 95% CI = 3.0-23.0; P < 0.0001). All study participants reported increased condom use; there was no significant difference between HOLA and waitlist control participants. In-depth interviews identified critical intervention elements and impacts and community needs and priorities. The HOLA intervention is effective for increasing HIV testing among Latinx GBMSM and TW, an initial step within the HIV prevention and care continua, and may be adaptable to promote pre-exposure prophylaxis uptake.",2020,"At follow-up, HOLA participants reported increased HIV testing (adjusted odds ratio = 8.3; 95% CI = 3.0-23.0; P < 0.0001).","['Social network participants (n\u2009=\u2009166', 'immigrant Spanish-speaking Latinx gay, bisexual and other men who have sex with men (GBMSM) and transgender women (TW']","['HOLA intervention', 'peer navigation intervention']",['HIV testing'],"[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}]",21.0,0.0335094,"At follow-up, HOLA participants reported increased HIV testing (adjusted odds ratio = 8.3; 95% CI = 3.0-23.0; P < 0.0001).","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Rhodes', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Alonzo', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Lilli', 'Initials': 'L', 'LastName': 'Mann-Jackson', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Eunyoung Y', 'Initials': 'EY', 'LastName': 'Song', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Tanner', 'Affiliation': 'Department of Public Health Education, University of North Carolina Greensboro, Greensboro, NC 27402, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Garcia', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Smart', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Logan S', 'Initials': 'LS', 'LastName': 'Baker', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Eng', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Rosenau Hall, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Reboussin', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA.'}]",Health education research,['10.1093/her/cyaa010']
3115,32441833,"Comparison of the clinical efficacy of daily use of L-arginine, tadalafil and combined L-arginine with tadalafil in the treatment of elderly patients with erectile dysfunction.","This study aimed to evaluate the efficacy of the daily oral administrations of L-arginine, tadalafil and combined L-arginine with tadalafil in treatments of elderly patients with erectile dysfunction (ED). It was designed as a single-blind placebo-controlled clinical trial. It was conducted on 120 male patients aged ≥60 years old with ED. Patients were randomised classified into four groups (n = 30 each). Oral daily use of L-arginine (5 g), tadalafil (5 mg), combined L-arginine (5 g) with tadalafil (5 mg) and placebo were taken for 6 weeks in each group of patients respectively. Patients were assessed before and after treatments using the Sexual Health Inventory for Men (SHIM) questionnaire and total serum testosterone. The means of Q1-5, total scores of SHIM and total testosterone, in L-arginine, tadalafil and combined L-arginine with tadalafil groups were significantly higher after treatments (p = .001). Combined L-arginine with tadalafil group had the highest SHIM scores and levels of total testosterone. This clinical trial deduced that the combined daily use of L-arginine with tadalafil therapy for elderly male patients with ED could significantly increase the SHIM scores and levels of total testosterone in comparison to L-arginine, or tadalafil alone.",2020,Combined L-arginine with tadalafil group had the highest SHIM scores and levels of total testosterone.,"['elderly patients with erectile dysfunction (ED', '120 male patients aged ≥60\xa0years old with ED', 'elderly male patients with ED', 'elderly patients with erectile dysfunction']","['L-arginine, tadalafil and combined L-arginine with tadalafil', 'L-arginine (5\xa0g), tadalafil (5\xa0mg), combined L-arginine', 'tadalafil', 'L-arginine with tadalafil therapy', 'Combined L-arginine with tadalafil', 'placebo']","['means of Q1-5, total scores of SHIM and total testosterone, in L-arginine, tadalafil and combined L-arginine', 'SHIM scores and levels of total testosterone', 'Sexual Health Inventory for Men (SHIM) questionnaire and total serum testosterone', 'highest SHIM scores and levels of total testosterone']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472504', 'cui_str': 'Sexual health inventory for men'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}]",120.0,0.0406742,Combined L-arginine with tadalafil group had the highest SHIM scores and levels of total testosterone.,"[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Abu El-Hamd', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Eisa Mohammed', 'Initials': 'EM', 'LastName': 'Hegazy', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, South Valley University, Qena, Egypt.'}]",Andrologia,['10.1111/and.13640']
3116,32437332,Robust antibody and cellular responses induced by DNA-only vaccination for HIV.,"BACKGROUND


HVTN 098, a randomized, double-blind, placebo-controlled trial, evaluated the safety, tolerability and immunogenicity of PENNVAX®-GP HIV DNA vaccine, administered with or without plasmid IL-12 (pIL-12), via intradermal (ID) or intramuscular (IM) electroporation (EP) in healthy, HIV-uninfected adults. The study tested whether PENNVAX®-GP delivered via ID/EP at 1/5th the dose could elicit equivalent immune responses to delivery via IM/EP, and if inclusion of pIL-12 provided additional benefit.
METHODS


Participants received DNA encoding HIV-1 env/gag/pol in three groups: 1.6mg ID (ID no IL-12 group, n=20), 1.6mg ID + 0.4mg pIL-12 (ID+IL-12 group, n=30), 8mg IM + 1mg pIL-12 (IM+IL-12 group, n=30) or placebo (n=9) via EP at 0, 1, 3 and 6 months. Results of cellular and humoral immunogencity assessments are reported.
RESULTS


Following vaccination, the frequency of responders (response rate) to any HIV protein based on CD4+ T-cells expressing IFN-γ and/or IL-2 was 96% for both the ID+IL-12 and IM+IL-12 groups; CD8+ T-cell response rates were 64% and 44%, respectively. For ID delivery, the inclusion of pIL-12 increased CD4+ T-cell response rate from 56% to 96%. The frequency of responders was similar (>90%) for IgG binding Ab to gp140 consensus Env across all groups, but the magnitude was higher in the ID+IL-12 group compared to the IM+IL-12 group.
CONCLUSION


PENNVAX®-GP DNA induced robust cellular and humoral immune responses, demonstrating that immunogenicity of DNA vaccines can be enhanced by EP route and inclusion of pIL-12. ID/EP was dose-sparing, inducing equivalent, or in some aspects superior, immune responses compared to IM/EP.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02431767Funding: This work was supported by the National Institute of Allergy and Infectious Diseases (NIAID, https://www.niaid.nih.gov/) U.S. Public Health Service Grants UM1 AI068618 [LC: HIV 75 Vaccine Trials Network], UM1 AI068614 [LOC: HIV Vaccine Trials Network], UM1 AI068635 76 [SDMC: HIV Vaccine Trials Network], , U01 AI069418-ˇ08 [Emory-ˇCDC Clinical Trials Unit], UM AI069511 [University of Rochester HIV/AIDS Clinical Trials Unit], UM1 AI069439 77 [Vanderbilt Clinical Trial Unit], UM1 AI069481 [Seattle-ˇLausanne Clinical Trials Unit] and HVDDT Contract HHSN2722008000063C (Inovio Pharmaceuticals). This work was also supported, in part, by IPCAVD award U19 AI09646-ˇ03 (DBW) and NIH award P01 AI120756 (GDT). The opinions expressed in this article are those of the authors and do not necessarily represent the official views of the NIAID or the National Institutes of Health (NIH).",2020,"The frequency of responders was similar (>90%) for IgG binding Ab to gp140 consensus Env across all groups, but the magnitude was higher in the ID+IL-12 group compared to the IM+IL-12 group.
","['healthy, HIV-uninfected adults']","['PENNVAX®-GP HIV DNA vaccine, administered with or without plasmid IL-12 (pIL-12), via intradermal (ID) or intramuscular (IM) electroporation (EP', 'PENNVAX®-GP delivered via ID/EP', 'ID + 0.4mg pIL-12 (ID+IL-12 group, n=30), 8mg IM + 1mg pIL-12 (IM+IL-12 group, n=30) or placebo', 'DNA encoding HIV-1 env/gag/pol in three groups: 1.6mg ID (ID no IL-12', 'placebo']","['safety, tolerability and immunogenicity', 'pIL-12 increased CD4+ T-cell response rate', 'CD8+ T-cell response rates', 'frequency of responders', 'frequency of responders (response rate) to any HIV protein based on CD4+ T-cells expressing IFN-γ and/or IL-2']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0486959', 'cui_str': 'Human immunodeficiency virus DNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0017343', 'cui_str': 'ENV gene'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C4517508', 'cui_str': '1.6'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1955876', 'cui_str': 'HIV Proteins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}]",,0.396959,"The frequency of responders was similar (>90%) for IgG binding Ab to gp140 consensus Env across all groups, but the magnitude was higher in the ID+IL-12 group compared to the IM+IL-12 group.
","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'DeRosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, United States of America.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University, Decatur, United States of America.'}, {'ForeName': 'Yunda', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, United States of America.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, United States of America.'}, {'ForeName': 'Marnie', 'Initials': 'M', 'LastName': 'Elizaga', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, United States of America.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Swann', 'Affiliation': 'Division of AIDS, National Institutes of Health, Bethesda, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Polakowski', 'Affiliation': 'Division of AIDS, National Institutes of Health, Bethesda, United States of America.'}, {'ForeName': 'Spyros A', 'Initials': 'SA', 'LastName': 'Kalams', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Vanderbilt, United States of America.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Keefer', 'Affiliation': 'Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, United States of America.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Maenza', 'Affiliation': 'Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, United States of America.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, United States of America.'}, {'ForeName': 'Megan C', 'Initials': 'MC', 'LastName': 'Wise', 'Affiliation': 'Vaccine and Immunotherapy Center, Inovio Pharmaceuticals, Philadelphia, United States of America.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Antigen Design, Inovio Pharmaceuticals, Plymouth Meeting, United States of America.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Morrow', 'Affiliation': 'Department of Immunology and Biomarkers, Inovio Pharmaceuticals, Plymouth Meeting, United States of America.'}, {'ForeName': 'Amir S', 'Initials': 'AS', 'LastName': 'Khan', 'Affiliation': 'Department of Antigen Design, inovio pharmaceuticals, Plymouth Meeting, United States of America.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Boyer', 'Affiliation': 'Department of Analytical Science, Inovio Pharmaceuticals, San Diego, United States of America.'}, {'ForeName': 'Laurent M', 'Initials': 'LM', 'LastName': 'Humeau', 'Affiliation': 'Department of Vaccine and Immunotherapy Center, Inovio Pharmaceuticals, San Diego, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'White', 'Affiliation': 'Department of Analytical Sciences, Inovio Pharmaceuticals, Plymouth Meeting, United States of America.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Pensiero', 'Affiliation': 'Division of AIDS, National Institutes of Health, Bethesda, United States of America.'}, {'ForeName': 'Niranjan Y', 'Initials': 'NY', 'LastName': 'Sardesai', 'Affiliation': 'Department of Immune Therapeutics, Inovio Pharmaceuticals, The Woodlands, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bagarazzi', 'Affiliation': 'Department of Clinical, Inovio Pharmaceuticals, Plymouth Meeting, United States of America.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Weiner', 'Affiliation': 'Department of Vaccines, The Wistar Institute, Philadelphia, United States of America.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, United States of America.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, United States of America.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, United States of America.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, United States of America.'}]",JCI insight,['10.1172/jci.insight.137079']
3117,32437937,Causes of fever in primary care in Southeast Asia and the performance of C-reactive protein in discriminating bacterial from viral pathogens.,"OBJECTIVES


We investigated causes of fever in the primary levels of care in Southeast Asia, and evaluated whether C-reactive protein (CRP) could distinguish bacterial from viral pathogens.
METHODS


Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5˚C) or history of fever (<14 days) in Thailand and Myanmar.
RESULTS


Of 773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected. Influenza virus type A was detected in 85/227 cases (37.5%), followed by dengue virus (30 cases, 13.2%), respiratory syncytial virus (24 cases, 10.6%) and Leptospira spp. (9 cases, 4.0%). Clinical outcome was similar between patients with a bacterial or a viral organism, regardless of antibiotic prescription. CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
CONCLUSIONS


Serious bacterial infections requiring antibiotics are exceptions rather than the rule in the first lines of care. CRP-testing could assist in ruling out such cases in settings where diagnostic uncertainty is high and routine antibiotic prescription is common. The original CRP randomised-controlled trial (RCT) was registered with ClinicalTrials.gov, number NCT02758821.",2020,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
","['fever in the primary levels of care in Southeast Asia', '773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected', 'Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5˚C) or history of fever (<14 days) in Thailand and Myanmar']",[],"['respiratory syncytial virus', 'CRP']","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003983', 'cui_str': 'South east Asian country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0006416', 'cui_str': 'Burma'}]",[],"[{'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",773.0,0.237316,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Althaus', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Rajthevee, Bangkok 10400, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: thomas.a@tropmedres.ac.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Thaipadungpanit', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Rajthevee, Bangkok 10400, Thailand.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Greer', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Rajthevee, Bangkok 10400, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'M M M', 'Initials': 'MMM', 'LastName': 'Swe', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Myanmar-Oxford Clinical Research Unit (MOCRU), Yangon, Myanmar - Medical Action Myanmar (MAM), 32A1 Kokkine Swimming Club Lane, Sayar San Rd, Yangon, Myanmar.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dittrich', 'Affiliation': 'Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Peerawaranun', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Rajthevee, Bangkok 10400, Thailand.'}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Smit', 'Affiliation': 'Maasstad Ziekenhuis hospital, Department of medical microbiology, Rotterdam, The Netherlands; Public Health Laboratory (GGD), Amsterdam, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wangrangsimakul', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Rajthevee, Bangkok 10400, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Blacksell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Rajthevee, Bangkok 10400, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Winchell', 'Affiliation': 'Division of bacterial diseases, Centers for Disease Control and Prevention, Atlanta, U.S.A.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Diaz', 'Affiliation': 'Division of bacterial diseases, Centers for Disease Control and Prevention, Atlanta, U.S.A.'}, {'ForeName': 'N P J', 'Initials': 'NPJ', 'LastName': 'Day', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Rajthevee, Bangkok 10400, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Smithuis', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Myanmar-Oxford Clinical Research Unit (MOCRU), Yangon, Myanmar - Medical Action Myanmar (MAM), 32A1 Kokkine Swimming Club Lane, Sayar San Rd, Yangon, Myanmar.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Turner', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Cambodia-Oxford Medical Research Unit (COMRU), Angkor Hospital for Children, Siem Reap, Cambodia.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lubell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Rajthevee, Bangkok 10400, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.05.016']
3118,32438041,"Corrigendum to ""Efficacy of strategies to increase participation in cervical cancer screening: GPs offering self-sampling kits for HPV testing versus recommendations to have a pap smear taken - A randomised controlled trial"". Papillomavirus Research 9 (2020) 100194.","BACKGROUND


Cervical cancer is preventable by early detection and treatment of pre-cancerous lesions. The current screening policy in Belgium (3-yearly cytology on Pap smears) covers 60% of the target population. Offering self-samples by GPs can overcome barriers for women who are currently not screened.
METHODS


Women aged 25-64 who did not have a Pap smear since three years and consulted a GP practice in a Flemish municipality between November, 2014 and April, 2015 were allocated in a 1:1 ratio to either the intervention arm where women were given a vaginal self-sampling kit or control arm where women were encouraged to make an appointment for having a Pap smear taken by a clinician.
RESULTS


Eighty-eight consenting women were randomised. 35 (78%) out of 45 women in the self-sampling arm participated in screening compared to 22 (51%) out of 43 women in the control arm (p=0.009). This difference remained significant after adjusting for covariates (age category, education level, time interval since last Pap smear, past Pap smear-taker).
CONCLUSION


GPs offering self-sampling kits resulted in a high participation. Larger trials should confirm this effect and evaluate feasibility of this approach.",2020,"This difference remained significant after adjusting for covariates (age category, education level, time interval since last Pap smear, past Pap smear-taker).
","['cervical cancer screening', 'women who are currently not screened', 'Eighty-eight consenting women', 'Women aged 25-64 who did not have a Pap smear since three years and consulted a GP practice in a Flemish municipality between November, 2014 and April, 2015']",['vaginal self-sampling kit or control arm where women were encouraged to make an appointment for having a Pap smear taken by a clinician'],"['education level, time interval since last Pap smear, past Pap smear-taker']","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0376242', 'cui_str': 'Flemish language'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C1444637', 'cui_str': 'Past'}]",88.0,0.039767,"This difference remained significant after adjusting for covariates (age category, education level, time interval since last Pap smear, past Pap smear-taker).
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Peeters', 'Affiliation': 'Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Cornet', 'Affiliation': 'De Groet, General Practice, Oetingen, Gooik, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cammu', 'Affiliation': 'Department Uro-gynaecology, UZ Brussels, Brussels, Belgium.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Verhoeven', 'Affiliation': 'Department of Primary and Interdisciplinary Care (ELIZA), University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Devroey', 'Affiliation': 'Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel, Brussels.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arbyn', 'Affiliation': 'Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium. Electronic address: marc.arbyn@sciensano.be.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100201']
3119,32437507,Effect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: The CheckMate 143 Phase 3 Randomized Clinical Trial.,"Importance


Clinical outcomes for glioblastoma remain poor. Treatment with immune checkpoint blockade has shown benefits in many cancer types. To our knowledge, data from a randomized phase 3 clinical trial evaluating a programmed death-1 (PD-1) inhibitor therapy for glioblastoma have not been reported.
Objective


To determine whether single-agent PD-1 blockade with nivolumab improves survival in patients with recurrent glioblastoma compared with bevacizumab.
Design, Setting, and Participants


In this open-label, randomized, phase 3 clinical trial, 439 patients with glioblastoma at first recurrence following standard radiation and temozolomide therapy were enrolled, and 369 were randomized. Patients were enrolled between September 2014 and May 2015. The median follow-up was 9.5 months at data cutoff of January 20, 2017. The study included 57 multicenter, multinational clinical sites.
Interventions


Patients were randomized 1:1 to nivolumab 3 mg/kg or bevacizumab 10 mg/kg every 2 weeks until confirmed disease progression, unacceptable toxic effects, or death.
Main Outcomes and Measures


The primary end point was overall survival (OS).
Results


A total of 369 patients were randomized to nivolumab (n = 184) or bevacizumab (n = 185). The MGMT promoter was methylated in 23.4% (43/184; nivolumab) and 22.7% (42/185; bevacizumab), unmethylated in 32.1% (59/184; nivolumab) and 36.2% (67/185; bevacizumab), and not reported in remaining patients. At median follow-up of 9.5 months, median OS (mOS) was comparable between groups: nivolumab, 9.8 months (95% CI, 8.2-11.8); bevacizumab, 10.0 months (95% CI, 9.0-11.8); HR, 1.04 (95% CI, 0.83-1.30); P = .76. The 12-month OS was 42% in both groups. The objective response rate was higher with bevacizumab (23.1%; 95% CI, 16.7%-30.5%) vs nivolumab (7.8%; 95% CI, 4.1%-13.3%). Grade 3/4 treatment-related adverse events (TRAEs) were similar between groups (nivolumab, 33/182 [18.1%]; bevacizumab, 25/165 [15.2%]), with no unexpected neurological TRAEs or deaths due to TRAEs.
Conclusions and Relevance


Although the primary end point was not met in this randomized clinical trial, mOS was comparable between nivolumab and bevacizumab in the overall patient population with recurrent glioblastoma. The safety profile of nivolumab in patients with glioblastoma was consistent with that in other tumor types.
Trial Registration


ClinicalTrials.gov Identifier: NCT02017717.",2020,"The objective response rate was higher with bevacizumab (23.1%; 95% CI, 16.7%-30.5%) vs nivolumab (7.8%; 95% CI, 4.1%-13.3%).","['patients with recurrent glioblastoma compared with bevacizumab', '439 patients with glioblastoma at first recurrence following standard radiation and temozolomide therapy were enrolled, and 369 were randomized', '369 patients', 'patients with glioblastoma', 'Patients With Recurrent Glioblastoma', 'Patients were enrolled between September 2014 and May 2015', '57 multicenter, multinational clinical sites']","['nivolumab', 'immune checkpoint blockade', 'nivolumab 3 mg/kg or bevacizumab', 'Nivolumab vs Bevacizumab', 'bevacizumab']","['safety profile of nivolumab', 'survival', 'median OS (mOS', 'Grade 3/4 treatment-related adverse events (TRAEs', 'objective response rate', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",439.0,0.244696,"The objective response rate was higher with bevacizumab (23.1%; 95% CI, 16.7%-30.5%) vs nivolumab (7.8%; 95% CI, 4.1%-13.3%).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Reardon', 'Affiliation': 'Dana-Farber/Harvard Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Alba A', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'AUSL-IRCCS Institute of Neurological Sciences, Bologna, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Omuro', 'Affiliation': 'Department of Neurology and Yale Cancer Center, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mulholland', 'Affiliation': 'University College London Hospitals, London, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lim', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Wick', 'Affiliation': 'Neurology Clinic, University of Heidelberg, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Baehring', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Manmeet S', 'Initials': 'MS', 'LastName': 'Ahluwalia', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Roth', 'Affiliation': 'Department of Neurology and Brain Tumor Center, University Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bähr', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, Goethe University Hospital, Frankfurt, Germany.'}, {'ForeName': 'Surasak', 'Initials': 'S', 'LastName': 'Phuphanich', 'Affiliation': 'Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Sepulveda', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'De Souza', 'Affiliation': 'University of Wollongong School of Medicine, Wollongong, NSW, Australia.'}, {'ForeName': 'Solmaz', 'Initials': 'S', 'LastName': 'Sahebjam', 'Affiliation': 'Moffitt Cancer Center, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Carleton', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Tatsuoka', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Taitt', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Zwirtes', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sampson', 'Affiliation': 'Duke University Hospital, Durham, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology and Brain Tumor Center, University Hospital and University of Zurich, Zurich, Switzerland.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1024']
3120,32438071,Baseline urinary metabolites predict albuminuria response to spironolactone in type 2 diabetes.,"The mineralocorticoid receptor antagonist spironolactone significantly reduces albuminuria in subjects with diabetic kidney disease, albeit with a large variability between individuals. Identifying novel biomarkers that predict response to therapy may help to tailor spironolactone therapy. We aimed to identify a set of metabolites for prediction of albuminuria response to spironolactone in subjects with type 2 diabetes. Systems biology molecular process analysis was performed a priori to identify metabolites linked to molecular disease processes and drug mechanism of action. Individual subject data and urine samples were used from 2 randomized placebo controlled double blind clinical trials (NCT01062763, NCT00381134). A urinary metabolite score was developed to predict albuminuria response to spironolactone therapy using penalized ridge regression with leave-one-out cross validation. Bioinformatic analysis identified a set of 18 metabolites linked to a diabetic kidney disease molecular model and potentially affected by spironolactone mechanism of action. Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively. In the test cohort, UACR reduction was higher in the lowest tertile of the baseline urinary metabolite score compared with middle and upper tertiles -58% (25th to 75% percentile -78 to 33), -28% (25th to 75% percentile -46 to 8), -40% (25th to 75% percentile -52% to 31), respectively, P = 0.001 for trend). In the replication cohort, UACR reduction was -54% (25th to 75% percentile -65 to -50), -41 (25th to 75% percentile -46% to 30), and -17% (25th to 75% percentile -36 to 5), respectively, P = 0.010 for trend). We identified a set of 18 urinary metabolites through systems biology to predict albuminuria response to spironolactone in type 2 diabetes. These data suggest that urinary metabolites may be used as a tool to tailor optimal therapy and move in the direction of personalized medicine.",2020,"Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively.","['subjects with diabetic kidney disease', 'type 2 diabetes', 'subjects with type 2 diabetes']","['spironolactone', 'mineralocorticoid receptor antagonist spironolactone', 'Spironolactone', 'spironolactone therapy', 'placebo']","['baseline urinary metabolite score', 'UACR reduction', 'albuminuria response', 'UACR relative']","[{'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0356557,"Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively.","[{'ForeName': 'Skander', 'Initials': 'S', 'LastName': 'Mulder', 'Affiliation': 'University Medical Center Groningen.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Perco', 'Affiliation': 'Medical University Innsbruck.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Oxlund', 'Affiliation': 'University of Southern Denmark.'}, {'ForeName': 'Uzma F', 'Initials': 'UF', 'LastName': 'Mehdi', 'Affiliation': 'UT Southwestern Medical Center.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hankemeier', 'Affiliation': 'Leiden University.'}, {'ForeName': 'Ib A', 'Initials': 'IA', 'LastName': 'Jacobsen', 'Affiliation': 'University of Southern Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Toto', 'Affiliation': 'UT Southwestern Medical Center.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'University Medical Center Groningen.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Pena', 'Affiliation': 'University Medical Center Groningen. Electronic address: m.pena@umcg.nl.'}]",Translational research : the journal of laboratory and clinical medicine,['10.1016/j.trsl.2020.04.010']
3121,32437393,"Fecal microbiota transplantation in systemic sclerosis: A double-blind, placebo-controlled randomized pilot trial.","OBJECTIVES


Systemic sclerosis (SSc) is an auto-immune, multi organ disease marked by severe gastrointestinal (GI) involvement and gut dysbiosis. Here, we aimed to determine the safety and efficacy of fecal microbiota transplantation (FMT) using commercially-available anaerobic cultivated human intestinal microbiota (ACHIM) in SSc.
METHODS


Ten patients with SSc were randomized to ACHIM (n = 5) or placebo (n = 5) in a double-blind, placebo-controlled 16-week pilot. All patients had mild to severe upper and lower GI symptoms including diarrhea, distention/bloating and/or fecal incontinence at baseline. Gastroduodenoscopy transfer of ACHIM or placebo was performed at weeks 0 and 2. Primary endpoints were safety and clinical efficacy on GI symptoms assessed at weeks 4 and 16. Secondary endpoints included changes in relative abundance of total, immunoglobulin (Ig) A- and IgM-coated fecal bacteria measured by 16s rRNA sequencing.
RESULTS


ACHIM side effects were mild and transient. Two placebo controls experienced procedure-related serious adverse events; one developed laryngospasms at week 0 gastroduodenoscopy necessitating study exclusion whilst one encountered duodenal perforation during gastroduodenoscopy at the last study visit (week 16). Decreased bloating, diarrhea and/or fecal incontinence was observed in four of five patients in the FMT group (week 4 or/and 16) and in two of four in the placebo group (week 4 or 16). Relative abundance, richness and diversity of total and IgA-coated and IgM-coated bacteria fluctuated more after FMT, than after placebo.
CONCLUSIONS


FMT of commercially-available ACHIM is associated with gastroduodenoscopy complications but reduces lower GI symptoms by possibly altering the gut microbiota in patients with SSc.",2020,"Relative abundance, richness and diversity of total and IgA-coated and IgM-coated bacteria fluctuated more after FMT, than after placebo.
","['Ten patients with SSc', 'systemic sclerosis', 'patients with SSc']","['fecal microbiota transplantation (FMT', 'FMT', 'ACHIM or placebo', 'ACHIM', 'Fecal microbiota transplantation', 'placebo']","['safety and clinical efficacy on GI symptoms', 'changes in relative abundance of total, immunoglobulin (Ig) A- and IgM-coated fecal bacteria measured by 16s rRNA sequencing', 'procedure-related serious adverse events', 'mild to severe upper and lower GI symptoms including diarrhea, distention/bloating and/or fecal incontinence', 'Decreased bloating, diarrhea and/or fecal incontinence', 'Relative abundance, richness and diversity of total and IgA-coated and IgM-coated bacteria fluctuated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0231241', 'cui_str': 'Fluctuating'}]",10.0,0.365308,"Relative abundance, richness and diversity of total and IgA-coated and IgM-coated bacteria fluctuated more after FMT, than after placebo.
","[{'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Fretheim', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Chung', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Didriksen', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Espen S', 'Initials': 'ES', 'LastName': 'Bækkevold', 'Affiliation': 'Department of Pathology and Centre for Immune Regulation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Midtvedt', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Brunborg', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Holm', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Valeur', 'Affiliation': 'Unger-Vetlesen Institute, Lovisenberg Diaconal Hospital, Oslo, Norway.'}, {'ForeName': 'Anders Heiervang', 'Initials': 'AH', 'LastName': 'Tennøe', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Torhild', 'Initials': 'T', 'LastName': 'Garen', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Midtvedt', 'Affiliation': 'Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Trøseid', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Hasse', 'Initials': 'H', 'LastName': 'Zarè', 'Affiliation': 'Clinical Trial Unit, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'May Brit', 'Initials': 'MB', 'LastName': 'Lund', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Hov', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Knut E A', 'Initials': 'KEA', 'LastName': 'Lundin', 'Affiliation': 'Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Molberg', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Hoffmann-Vold', 'Affiliation': 'Department of Rheumatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}]",PloS one,['10.1371/journal.pone.0232739']
3122,32438043,Optimizing the Conditioning Regimen for HCT in Myelofibrosis: Long-term Results of a Prospective Phase II Clinical Trial.,"BACKGROUND


Optimal conditioning regimen for older patients with myelofibrosis undergoing allogeneic hematopoietic cell transplantation (HCT) is not known. Likewise, role of dose intensity is not clear.
METHODS


We conducted a non-randomized prospective phase II trial using low-dose, later escalated to high-dose (MAC) busulfan with fludarabine (Bu-Flu) in myelofibrosis patients up to 74 years. First 15 patients received intravenous busulfan 130 mg/m 2 /day on days -3 and -2 (""low dose""); 31 received high dose - either 100 mg/m 2 /day (days -5 to -2; n=4) or pharmacokinetic-guided area under the curve of 4,000 μmol.min (days -5 to -2; n=27). Primary endpoint was day 100 non-relapse mortality (NRM).
FINDINGS


Median age was 58 years (interquartile range (IQR) 53-63). Dynamic international prognostic scoring system (DIPSS)-plus was intermediate (n=28) or high (n=18). Donors were related (n=19) or unrelated (n=27). Cumulative incidence of NRM was 9.7% (95% confidence interval (CI) 0-20.3) at day 100 and at 3 years in the high dose, while it was 0% in the low dose group at day 100, and increased to 20% (95% CI 0-41.9) at 3 years. With a median follow up of 5.1 years (IQR 3.8-6), 3-year relapse was 32.3% (95% CI 15.4-49.1) in high dose versus 53.3% (95% CI 26.6-80.1) in low dose; event-free survival was 58% (95% CI 43-78%) versus 27% (95% CI 12-62%), and overall survival was 74% (95% CI 60-91%) versus 60% (95% CI 40-91%) respectively. In multivariate analysis, high dose busulfan had a trend towards lower relapse (Hazard ratio (HR) 0.44, 95% CI, 0.18-1.07, p=0.07), with no impact on NRM.
INTERPRETATION


Intensifying Bu-Flu regimen using pharmacokinetic-monitoring appears promising in reducing relapse without increasing non-relapse mortality.
FUNDING


The study was supported partly by Otsuka pharmaceutical and partly by the Cancer Center Support Grant (NCI Grant P30 CA016672).",2020,"Cumulative incidence of NRM was 9.7% (95% confidence interval (CI) 0-20.3) at day 100 and at 3 years in the high dose, while it was 0% in the low dose group at day 100, and increased to 20% (95% CI 0-41.9) at 3 years.","['older patients with myelofibrosis undergoing allogeneic hematopoietic cell transplantation (HCT', 'Median age was 58 years (interquartile range (IQR) 53-63', 'Donors were related (n=19) or unrelated (n=27', 'myelofibrosis patients up to 74 years']","['later escalated to high-dose (MAC) busulfan with fludarabine (Bu-Flu', 'intravenous busulfan']","['lower relapse (Hazard ratio (HR', 'overall survival', 'free survival', 'Cumulative incidence of NRM', '3-year relapse', 'day 100 non-relapse mortality (NRM']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001815', 'cui_str': 'Myelosclerosis with myeloid metaplasia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.306467,"Cumulative incidence of NRM was 9.7% (95% confidence interval (CI) 0-20.3) at day 100 and at 3 years in the high dose, while it was 0% in the low dose group at day 100, and increased to 20% (95% CI 0-41.9) at 3 years.","[{'ForeName': 'Uday', 'Initials': 'U', 'LastName': 'Popat', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA. Electronic address: upopat@mdanderson.org.'}, {'ForeName': 'Rohtesh S', 'Initials': 'RS', 'LastName': 'Mehta', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Bassett', 'Affiliation': 'Department of Biostatistics, University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Piyanuch', 'Initials': 'P', 'LastName': 'Kongtim', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA; Division of Hematology Department of Internal Medicine Faculty of Medicine Thammasat University, Thailand.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Amin M', 'Initials': 'AM', 'LastName': 'Alousi', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Anderlini', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ciurea', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Hosing', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Partow', 'Initials': 'P', 'LastName': 'Kebriaei', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Issa', 'Initials': 'I', 'LastName': 'Khouri', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Richard Lindsay', 'Initials': 'RL', 'LastName': 'Pa', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yago', 'Initials': 'Y', 'LastName': 'Nieto', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Olson', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Betul', 'Initials': 'B', 'LastName': 'Oran', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Muzaffar H', 'Initials': 'MH', 'LastName': 'Qazilbash', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Rondon', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Shpall', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Srdan', 'Initials': 'S', 'LastName': 'Verstovsek', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Borje S', 'Initials': 'BS', 'LastName': 'Andersson', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Champlin', 'Affiliation': 'Departments of Stem Cell Transplantation and Cellular Therapy University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.03.020']
3123,31422924,Prognostic performance of the Society of Thoracic Surgeons risk score in patients with left main coronary artery disease undergoing revascularisation: a post hoc analysis of the EXCEL trial.,"AIMS


Accurate risk prediction in patients undergoing revascularisation is essential. We aimed to assess the predictive performance of Society of Thoracic Surgeons (STS) risk models in patients with left main coronary artery disease (LMCAD) undergoing coronary artery bypass grafting (CABG) or percutaneous coronary intervention with everolimus-eluting stents (PCI-EES).
METHODS AND RESULTS


The predictive performance of STS risk models for perioperative mortality, stroke and renal failure was evaluated for their discriminative ability (C statistic) and calibration (Hosmer-Lemeshow goodness-of-fit-test; χ2 and p-values) among patients with LMCAD undergoing PCI-EES (n=935) and CABG (n=923) from the randomised EXCEL trial. STS risk scores, in CABG patients, showed good discrimination for 30-day mortality and average discrimination for stroke (C statistic 0.730 and 0.629, respectively) with average calibration. For PCI, STS risk scores had no discrimination for mortality (C statistic 0.507), yet good discrimination (C statistic 0.751) and calibration for stroke. The predictive performance for renal failure was good for CABG (C statistic 0.82), yet poor for PCI (C statistic 0.59).
CONCLUSIONS


In selected patients with LMCAD from the EXCEL trial, STS risk models showed good predictive performance for CABG yet lacked predictive performance for PCI for perioperative mortality and renal failure. The STS stroke risk model was surprisingly more discriminating in PCI compared to CABG. Improved and procedure-specific risk prediction instruments are needed to accurately estimate adverse events after LMCAD revascularisation by CABG and PCI. ClinicalTrials.gov Identifier: NCT01205776.",2020,"For PCI, STS risk scores had no discrimination for mortality (C statistic 0.507), yet good discrimination (C statistic 0.751) and calibration for stroke.","['Patients with Left Main Coronary Artery Disease Undergoing Revascularization in the EXCEL trial', 'patients with left main coronary artery disease (LMCAD) undergoing coronary artery bypass grafting (CABG) or percutaneous coronary intervention with everolimus-eluting stents (PCI-EES', 'patients with LMCAD undergoing PCI-EES (n=935) and CABG (n=923', 'patients undergoing revascularization is essential']",[],"['STS risk scores', 'predictive performance for renal failure', '30-day mortality and average discrimination for stroke', 'perioperative mortality, stroke and renal failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C2740529', 'cui_str': 'Excel'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205224', 'cui_str': 'Essential (qualifier value)'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",,0.06067,"For PCI, STS risk scores had no discrimination for mortality (C statistic 0.507), yet good discrimination (C statistic 0.751) and calibration for stroke.","[{'ForeName': 'Daniel J F M', 'Initials': 'DJFM', 'LastName': 'Thuijs', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Habib', 'Affiliation': ''}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Head', 'Affiliation': ''}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': ''}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Taggart', 'Affiliation': ''}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ''}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': ''}, {'ForeName': 'A Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00417']
3124,32437569,Physical activity and risk of cardiovascular events and all-cause mortality among kidney transplant recipients.,"BACKGROUND


Insufficient physical activity (PA) may increase the risk of all-cause mortality and cardiovascular disease (CVD) morbidity and mortality among kidney transplant recipients (KTRs), but limited research is available. We examine the relationship between PA and the development of CVD events, CVD death and all-cause mortality among KTRs.
METHODS


A total of 3050 KTRs enrolled in an international homocysteine-lowering randomized controlled trial were examined (38% female; mean age 51.8 ± 9.4 years; 75% white; 20% with prevalent CVD). PA was measured at baseline using a modified Yale Physical Activity Survey, divided into tertiles (T1, T2 and T3) from lowest to highest PA. Kaplan-Meier survival curves were used to graph the risk of events; Cox proportional hazards regression models examined the association of baseline PA levels with CVD events (e.g. stroke, myocardial infarction), CVD mortality and all-cause mortality over time.
RESULTS


Participants were followed up to 2500 days (mean 3.7 ± 1.6 years). The cohort experienced 426 CVD events and 357 deaths. Fully adjusted models revealed that, compared to the lowest tertile of PA, the highest tertile experienced a significantly lower risk of CVD events {hazard ratio [HR] 0.76 [95% confidence interval (CI) 0.59-0.98]}, CVD mortality [HR 0.58 (95% CI 0.35-0.96)] and all-cause mortality [HR 0.76 (95% CI 0.59-0.98)]. Results were similar in unadjusted models.
CONCLUSIONS


PA was associated with a reduced risk of CVD events and all-cause mortality among KTRs. These observed associations in a large, international sample, even when controlling for traditional CVD risk factors, indicate the potential importance of PA in reducing CVD and death among KTRs.",2020,"Fully adjusted models revealed that, compared to the lowest tertile of PA, the highest tertile experienced a significantly lower risk of CVD events {hazard ratio [HR] 0.76","['A total of 3050 KTRs enrolled in an international homocysteine-lowering randomized controlled trial were examined (38% female', 'kidney transplant recipients (KTRs', 'kidney transplant recipients', 'mean age 51.8\u2009±\u20099.4\u2009years; 75% white; 20% with prevalent CVD', 'Participants were followed up to 2500\u2009days (mean 3.7\u2009±\u20091.6\u2009years']",[],"['PA', 'Physical activity and risk of cardiovascular events', 'baseline PA levels with CVD events (e.g. stroke, myocardial infarction), CVD mortality and all-cause mortality', 'Kaplan-Meier survival curves', 'reduced risk of CVD events', 'CVD mortality ']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4319601', 'cui_str': '2500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C4517508', 'cui_str': '1.6'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",3050.0,0.0529124,"Fully adjusted models revealed that, compared to the lowest tertile of PA, the highest tertile experienced a significantly lower risk of CVD events {hazard ratio [HR] 0.76","[{'ForeName': 'Augustine W', 'Initials': 'AW', 'LastName': 'Kang', 'Affiliation': 'Center for Health Equity Research, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Bostom', 'Affiliation': 'Department of Family Medicine, Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Hongseok', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Eaton', 'Affiliation': 'Department of Family Medicine, Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Gohh', 'Affiliation': 'Division of Nephrology, Rhode Island Hospital, Providence, RI, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Kusek', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Risica', 'Affiliation': 'Center for Health Equity Research, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Garber', 'Affiliation': ""Teachers' College, Columbia University, New York, NY, USA.""}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa038']
3125,32437626,Addition of Povidone-Iodine to Fluoride Varnish for Dental Caries: A Randomized Clinical Trial.,"INTRODUCTION


Dental caries is the most common chronic childhood disease. Products of metabolism by bacteria populating the tooth surface induce development and progression of cavities.
OBJECTIVES


We sought to determine whether a polyvinylpyrrolidone-iodine (PVP-I; povidone-iodine) and NaF topical varnish was superior to one containing only NaF in prevention of new dental caries lesions in a single-center randomized active-controlled trial based on a double-blind, parallel-group design.
METHODS


The site was Pohnpei State, Federated States of Micronesia. The study population was healthy children 49 to 84 mo old who were enrolled in early childhood education: 284 were randomized (1:1 allocation), and 273 were included in year 1 analysis and 262 in year 2. The test varnish contained 10% PVP-I and 5.0% NaF. The comparator contained only 5.0% NaF but was otherwise identical. Varnishes were applied every 3 mo during 2 y. The primary outcome was the surface-level primary molar caries lesion increment (d 2-4 mfs) at 2 y. Caries lesion increments from baseline to year 1 and year 2 were compared between conditions with log-linear regression, adjusting for age and sex and whether the tooth was sound at baseline (free of caries lesions).
RESULTS


At year 1, the caries lesion increment for primary molars sound at baseline was 0.9 surfaces (SD = 1.5) for the test varnish versus 1.8 (SD = 2.2) for the comparator varnish with fluoride alone (adjusted rate ratio, 0.50; 95% CI, 0.31 to 0.81; P = .005). At year 2, the caries lesion increment for primary molars sound at baseline was 2.3 surfaces (SD = 2.8) for the test varnish as compared with 3.3 (SD = 2.7) for the comparator (adjusted rate ratio, 0.74; 95% CI, 0.52 to 1.03; P = .073). Teeth that were already cavitated at baseline did not show a preventive effect. There were no harms.
CONCLUSIONS


A dental varnish containing PVP-I and NaF is effective in the primary prevention of cavities in the primary dentition (NCT03082196).
KNOWLEDGE TRANSFER STATEMENT


This study demonstrates that periodic application of a varnish containing NaF and PVP-I is effective in prevention of caries lesions and useful in assessing the potential of combined treatment.",2020,"A dental varnish containing PVP-I and NaF is effective in the primary prevention of cavities in the primary dentition (NCT03082196).
","['healthy children 49 to 84 mo old who were enrolled in early childhood education: 284 were randomized (1:1 allocation), and 273 were included in year 1 analysis and 262 in year 2', 'Dental Caries']","['Fluoride Varnish', 'varnish containing NaF and PVP-I', 'polyvinylpyrrolidone-iodine (PVP-I; povidone-iodine) and NaF topical varnish', 'Povidone-Iodine']","['surface-level primary molar caries lesion increment', 'caries lesion increment']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",284.0,0.50793,"A dental varnish containing PVP-I and NaF is effective in the primary prevention of cavities in the primary dentition (NCT03082196).
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Milgrom', 'Affiliation': 'Department of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Tut', 'Affiliation': 'Department of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rothen', 'Affiliation': 'Regional Clinical Dental Research Center, Institute of Translational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mancl', 'Affiliation': 'Department of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gallen', 'Affiliation': 'Department of Dental Services, Pohnpei State Department of Health Services, Kolonia, Federated States of Micronesia.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Tanzer', 'Affiliation': 'Department of Oral and Maxillofacial Diagnostic Sciences, University of Connecticut Health, Farmington, CT, USA.'}]",JDR clinical and translational research,['10.1177/2380084420922968']
3126,32437629,A Pilot Randomized Controlled Trial of the Alliance Project Gatekeeper Training for Suicide Prevention.,"Gatekeeper trainings are an approach intended to increase help seeking for suicide prevention. However, little is known of gatekeeper training's function in increasing gatekeeper intent to intervene with those in distress. The current study utilized the theory of planned behavior as a guide to predict gatekeeper's intention to intervene over a six-month period in a pilot randomized controlled trial of the Alliance Project gatekeeper training. Results suggested that the Alliance Project, predicted the growth curve of trainees' intention to intervene better than a control training from pretest through six months. Attitudes toward completing gatekeeper behaviors and perceived behavioral control over gatekeeper behaviors approached significance in a less parsimonious model. These findings suggest the Alliance Project produces changes in gatekeeper's intent to intervene through three months' time.",2020,"Results suggested that the Alliance Project, predicted the growth curve of trainees' intention to intervene better than a control training from pretest through six months.",[],"['Alliance Project Gatekeeper Training', 'Alliance Project gatekeeper training']",[],[],"[{'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0297618,"Results suggested that the Alliance Project, predicted the growth curve of trainees' intention to intervene better than a control training from pretest through six months.","[{'ForeName': 'Shane T W', 'Initials': 'STW', 'LastName': 'Kuhlman', 'Affiliation': ''}, {'ForeName': 'Phillip N', 'Initials': 'PN', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Marie', 'Affiliation': ''}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Fadoir', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Hudson', 'Affiliation': ''}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2020.1767246']
3127,32437690,Effect of anodal transcranial direct current stimulation at the right dorsolateral prefrontal cortex on the cognitive function in patients with mild cognitive impairment: a randomized double-blind controlled trial.,"OBJECTIVES


Study the effect of anodal transcranial direct stimulation (atDCS) of the right dorsolateral prefrontal cortex (DLPFC) on cognitive function and side effects in patients with mild cognitive impairment (MCI).
STUDY DESIGN


Experimental double-blind randomized, sham-controlled trial SETTING: Department of Rehabilitation Medicine, Tertiary Hospital SUBJECTS: Volunteers with MCI METHODS: Participants (45) who met the inclusion criteria were randomly allocated by block randomization into two groups. The atDCS group (23 participants) were stimulated at 2 mA for 20 min with the anode on the right DLPFC and cathode on the left supraorbital area. The control group (22 participants) received placebo stimulation. Baseline cognitive function was assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB) test. Participants were treated three times per week for four weeks (12 sessions). Cognitive function and side effects were assessed immediately after the first stimulation, the last session and 4 weeks post-treatment.
RESULTS


CANTAB results revealed a significant improvement in the accuracy of the visual sustained attention (VSA) in the atDCS group at all three time points, the spatial working memory (SWM) and visual memory (VM) immediately after the first stimulation and a decreased VM reaction time after 12 sessions. Long lasting effect on VSA and VM were found 4 weeks post-treatment.
CONCLUSION


Anodal tDCS over the right DLPFC enhanced the VSA, SWM and VM accuracy after the first stimulation and reduced the reaction time of VM after 12 sessions. Long lasting effect on VSA and VM were found 4 weeks post-treatment. This study corroborated atDCS as a safe technique to improve cognitive function.",2020,"Anodal tDCS over the right DLPFC enhanced the VSA, SWM and VM accuracy after the first stimulation and reduced the reaction time of VM after 12 sessions.","[' Participants (45) who met the inclusion criteria', 'patients with mild cognitive impairment', 'Department of Rehabilitation Medicine, Tertiary Hospital SUBJECTS', 'patients with mild cognitive impairment (MCI']","['anodal transcranial direct current stimulation', 'anodal transcranial direct stimulation (atDCS) of the right dorsolateral prefrontal cortex (DLPFC', 'placebo stimulation']","['Baseline cognitive function', 'reaction time of VM', 'VSA, SWM and VM accuracy', 'spatial working memory (SWM) and visual memory (VM', 'Cognitive function and side effects', 'VM reaction time', 'cognitive function', 'accuracy of the visual sustained attention (VSA', 'VSA and VM', 'Cambridge Neuropsychological Test Automated Battery (CANTAB) test', 'cognitive function and side effects']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C4505411', 'cui_str': 'CANTAB'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",45.0,0.0855784,"Anodal tDCS over the right DLPFC enhanced the VSA, SWM and VM accuracy after the first stimulation and reduced the reaction time of VM after 12 sessions.","[{'ForeName': 'Chernkhuan', 'Initials': 'C', 'LastName': 'Stonsaovapak', 'Affiliation': 'Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital.'}, {'ForeName': 'Solaphat', 'Initials': 'S', 'LastName': 'Hemrungroj', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Chulalongkorn University.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Terachinda', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Krisna', 'Initials': 'K', 'LastName': 'Piravej', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: kppmrchula@gmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.023']
3128,31351121,Identifying compliant participants through data matching improved estimation of intervention efficacy: randomized trials with opt-in/opt-out strategies.,"OBJECTIVES


We propose a data-matching approach to estimate intervention efficacy for randomized controlled trials (RCTs) when there is noncompliance to the allocated treatment with induced selection bias.
STUDY DESIGN AND SETTING


We considered a large RCT to compare health care costs and hospital length of stay 12 months after randomization. Participants allocated to the intervention group were eligible to receive health-coaching and disease-management services. An opt-out approach was adopted for recruitment. Control-group participants received usual care but were allowed to opt-in to receive the intervention. Using ""nearest-neighbor""-matched data, we identified compliant participants in both arms to estimate intervention efficacy. Results were compared with intention-to-treat (ITT), instrumental-variable-adjusted ITT, per-protocol (PP), and as-treated (AT) analyses.
RESULTS


The ITT estimated an intervention effect of a 1.5% reduction in cost, but 56.7% of intervention-group participants did not receive health coaching. The PP and AT found an increase in cost of 9.4% and 17.1%, respectively. The matching method estimated a 12.3% reduction in cost. After adjustment for baseline covariates, the intervention group had lower same-day admission cost (13.6%; 95% CI: 7.3%-20.0%; P < 0.001) and shorter hospital stay (11.2%; 95% CI: 2.6%-19.9%; P = 0.021).
CONCLUSION


Opt-in/opt-out strategies in RCTs misled intervention comparisons and the matching approach improved estimation of intervention efficacy.",2019,"After adjustment for baseline covariates, the intervention group had lower same-day admission cost (13.6%; 95% CI: 7.3%-20.0%; P < 0.001) and shorter hospital stay (11.2%; 95% CI: 2.6%-19.9%; P = 0.021).
",[],"['Control-group participants received usual care but were allowed to opt-in to receive the intervention', 'health-coaching and disease-management services']","['shorter hospital stay', 'lower same-day admission cost']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376636', 'cui_str': 'Disease Management'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.10387,"After adjustment for baseline covariates, the intervention group had lower same-day admission cost (13.6%; 95% CI: 7.3%-20.0%; P < 0.001) and shorter hospital stay (11.2%; 95% CI: 2.6%-19.9%; P = 0.021).
","[{'ForeName': 'Shu Kay', 'Initials': 'SK', 'LastName': 'Ng', 'Affiliation': 'School of Medicine and Menzies Health Institute Queensland, Griffith University, Nathan Q4111, Australia. Electronic address: s.ng@griffith.edu.au.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Byrnes', 'Affiliation': 'School of Medicine and Menzies Health Institute Queensland, Griffith University, Nathan Q4111, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Scuffham', 'Affiliation': 'School of Medicine and Menzies Health Institute Queensland, Griffith University, Nathan Q4111, Australia.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.07.013']
3129,32438600,Increasing Physical Activity in Empty Nest and Retired Populations Online: A Randomized Feasibility Trial Protocol.,"Despite the extensive evidence on the benefits of physical activity (PA) in older adults, including reduced risk of disease, mortality, falls, and cognitive and functional decline, most do not attain sufficient PA levels. Theoretical work suggests that behavioral change interventions are most effective during life transitions, and as such, a theory-based, online intervention tailored for recently retired and empty nest individuals could lend support for increasing levels of PA. The aim of this study is to examine the feasibility of the intervention and study procedures for a future controlled trial. This study has a randomized controlled trial design with an embedded qualitative and quantitative process evaluation. Participants are randomized at 1:1 between the intervention and waitlist controls. Potential participants are within six months of their final child leaving the familial home or within six months of retiring (self-defined), currently not meeting the Canadian PA guidelines, have no serious contraindications to exercise, and are residing in Victoria, British Columbia, Canada. Participants are recruited by online and print flyers as well as in-person at community events. The study aims to recruit 40 empty nest and 40 retired participants; half of each group received the intervention during the study period. The internet-delivered intervention is delivered over a 10-week period, comprising 10 modules addressing behavior change techniques associated with PA. Primary outcomes relate to recruitment, attrition, data collection, intervention delivery, and acceptability. Secondary behavioral outcomes are measured at baseline and post-treatment (10 weeks). Intervention-selected participants are invited to an optional qualitative exit interview. The results of this feasibility study will inform the planning of a randomized effectiveness trial, that will examine the behavior change, health-related fitness, and well-being outcomes by exploring how reflexive processes of habit and identity may bridge adoption and maintenance in behavioral adherence.",2020,"The results of this feasibility study will inform the planning of a randomized effectiveness trial, that will examine the behavior change, health-related fitness, and well-being outcomes by exploring how reflexive processes of habit and identity may bridge adoption and maintenance in behavioral adherence.","['older adults', 'Empty Nest and Retired Populations Online', 'Participants are recruited by online and print flyers as well as in-person at community events']",[],"['recruitment, attrition, data collection, intervention delivery, and acceptability', 'risk of disease, mortality, falls, and cognitive and functional decline']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",[],"[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.103504,"The results of this feasibility study will inform the planning of a randomized effectiveness trial, that will examine the behavior change, health-related fitness, and well-being outcomes by exploring how reflexive processes of habit and identity may bridge adoption and maintenance in behavioral adherence.","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cox', 'Affiliation': 'Behavioural Medicine Laboratory, Department of Education, University of Victoria, Victoria, BC V8W 3N4, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Rhodes', 'Affiliation': 'Behavioural Medicine Laboratory, Department of Education, University of Victoria, Victoria, BC V8W 3N4, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17103544']
3130,32437568,Association of motivations and barriers with participation and performance in a pedometer-based intervention.,"BACKGROUND


A randomized trial of a pedometer-based intervention with weekly activity goals led to increased walking among dialysis patients. However, the association of participant-expressed motivations and barriers to participation and performance in such an intervention has not been determined.
METHODS


Thirty dialysis patients were randomized to a 12-week pedometer-based intervention with weekly step goals. Participants were asked about motivations and barriers to the increasing activity via weekly semi-scripted telephone interviews. We examined the association of these motivations and barriers with achieving weekly goals, reaching overall targets and increasing steps through multivariable linear and logistic regression analyses adjusted for age, sex, body mass index, dialysis modality and baseline steps.
RESULTS


The most common motivations were desire to maintain/improve functional ability (30%) and activity (30%). The most common barriers were health-related (33%). Motivation to maintain/improve functional ability was associated with achieving weekly goals 17.9% more often [95% confidence interval (CI) 1.7-34.2] and with a greater increase in steps (1524 steps; 95% CI 61-2989) than those lacking this motivation. Experiencing a health-related barrier was not associated with the decreased achievement of weekly goals but was associated with lower odds of reaching overall targets (odds ratio = 0.06; 95% CI 0.01-0.53) and a smaller increase in steps (-1640 steps, 95% CI -3244 to -36). No patients who reported weather/environmental barriers or safety concerns reached overall targets.
CONCLUSIONS


Participants who express a desire to maintain/improve functional ability may be particularly suited for activity interventions. Health-related setbacks should be met with revised goals. Reporting environmental or safety concerns may merit lowering overall targets.",2020,Motivation to maintain/improve functional ability was associated with achieving weekly goals 17.9% more often [95% confidence interval (CI) 1.7-34.2] and with a greater increase in steps (1524 steps; 95% CI 61-2989) than those lacking this motivation.,"['dialysis patients', 'Thirty dialysis patients']",[],"['Motivation to maintain/improve functional ability', 'functional ability']","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}]",[],"[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.0511484,Motivation to maintain/improve functional ability was associated with achieving weekly goals 17.9% more often [95% confidence interval (CI) 1.7-34.2] and with a greater increase in steps (1524 steps; 95% CI 61-2989) than those lacking this motivation.,"[{'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Sheshadri', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Piyawan', 'Initials': 'P', 'LastName': 'Kittiskulnam', 'Affiliation': 'Department of Medicine-Division of Nephrology, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Delgado', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sudore', 'Affiliation': 'Department of Medicine, Division of Nephrology, San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Lai', 'Affiliation': 'Department of Medicine, Division of Gastroenterology/Hepatology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Johansen', 'Affiliation': 'Division of Nephrology, Hennepin County Medical Center, Minneapolis, MN, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa047']
3131,32437703,"Reactions to graphic and text health warnings for cigarettes, sugar-sweetened beverages, and alcohol: An online randomized experiment of US adults.","We aimed to examine reactions to graphic versus text-only warnings among cigarette, SSB, and alcohol warnings. A convenience sample of US adults completed an online survey in 2018 (n = 1352 in the analytic sample). We randomly assigned participants to view a: 1) text-only warning without efficacy information (i.e., message intended to increase consumers' confidence in their ability to stop using the product), 2) text-only warning with efficacy information, 3) graphic warning without efficacy information, or 4) graphic warning with efficacy information. Participants viewed their assigned warning on cigarettes, SSBs, and alcohol, in a random order. Across product types, graphic warnings were perceived as more effective than text-only warnings (p < .001) and led to lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal (all p < .05); policy support did not differ. Compared to SSB and alcohol warnings, cigarette warnings led to higher perceived message effectiveness, believability, fear, thinking about harms, policy support, and greater reductions in product appeal (all p < .05). The efficacy information did not influence any outcomes. Graphic warnings out-performed text-only warnings on key predictors of behavior despite causing more reactance.",2020,"Across product types, graphic warnings were perceived as more effective than text-only warnings (p < .001) and led to lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal (all p < .05); policy support did not differ.","['A convenience sample of US adults completed an online survey in 2018 (n\u202f=\u202f1352 in the analytic sample', 'cigarettes, sugar-sweetened beverages, and alcohol', 'US adults']","[""text-only warning without efficacy information (i.e., message intended to increase consumers' confidence in their ability to stop using the product), 2) text-only warning with efficacy information, 3) graphic warning without efficacy information, or 4) graphic warning with efficacy information""]","['message effectiveness, believability, fear, thinking about harms, policy support', 'lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332288', 'cui_str': 'Without'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0359166,"Across product types, graphic warnings were perceived as more effective than text-only warnings (p < .001) and led to lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal (all p < .05); policy support did not differ.","[{'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA. Electronic address: mghall@unc.edu.'}, {'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Grummon', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; Center for Population and Development Studies, Harvard TH Chan School of Public Health, Cambridge, MA, USA; Carolina Population Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Maynard', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, School of Psychological Science, University of Bristol, Bristol, UK; MRC Integrative Epidemiology Unit (IEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Lindsey Smith', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA; Carolina Population Center, University of North Carolina, Chapel Hill, NC, USA; Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106120']
3132,31368367,Effect of napping opportunity at different times of day on vigilance and shuttle run performance.,"The aim of the present study was to examine the effect of a nap opportunity during the daytime realized at different times of day on physical and mental performance. Eighteen physically active males (age: 20.5 ± 3.0 years, height: 175.3 ± 5.9 cm, body-mass: 70.0 ± 8.6 kg) were tested under four experimental conditions: no-nap condition, nap at 13h00, nap at 14h00 and nap at 15h00. All nap durations were of 25-min and all tests were performed at 17h00. They performed a 5-m shuttle run test, which generated measures of the highest distance (HD) and total distance (TD). The rating of perceived exertion (RPE) was recorded after each of the six sprints in the 5-m shuttle run test. Vigilance was measured using a digit cancellation test. The results showed that TD at 17h00 was 4% greater after a nap at 14h00 than in the no-nap condition (+28 m,  p  < .05) or after the nap at 13h00 (+29 m,  p  < .05). HD was 8% higher (+9 m,  p  < .001) after a nap at 14h00 than in the no-nap condition and 7% higher after nap at 15h00 than in the no-nap condition (+7 m,  p  < .05). In addition, HD was 6% higher after nap at 14h00 (+7 m,  p  < .01) and 5% higher after nap at 15h00 (+9 m,  p  < .01) than HD after a nap at 13h00. Napping at 13h00 had no effect on physical performance at 17h00. No significant differences were observed between RPE and vigilance scores in the nap and no-nap conditions. In conclusion, napping for 25 min at 14h00 and 15h00 produces meaningful improvements in responses during repeated short-term maximal exercise tests performed at 17h00. Napping at 13h00 does not. Vigilance, as measured using a digit cancellation test, and RPE scores are not influenced by any of the nap opportunities.",2019,"In addition, HD was 6% higher after nap at 14h00 (+7 m,  p  < .01) and 5% higher after nap at 15h00 (+9 m,  ","['Eighteen physically active males (age: 20.5\xa0±\xa03.0\xa0years, height: 175.3\xa0±\xa05.9 cm, body-mass: 70.0\xa0±\xa08.6 kg) were tested under four experimental conditions: no-nap condition, nap at 13h00, nap at 14h00 and nap at 15h00']",[],"['Vigilance', 'rating of perceived exertion (RPE', 'digit cancellation test, and RPE scores', 'highest distance (HD) and total distance (TD', 'physical performance', 'HD', 'RPE and vigilance scores']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}]",[],"[{'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2607857'}]",18.0,0.0297485,"In addition, HD was 6% higher after nap at 14h00 (+7 m,  p  < .01) and 5% higher after nap at 15h00 (+9 m,  ","[{'ForeName': 'Raouf', 'Initials': 'R', 'LastName': 'Abdessalem', 'Affiliation': 'Education, Motricité, Sport et Santé (EM2S), UR15JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax , Sfax , Tunisia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Boukhris', 'Affiliation': 'Education, Motricité, Sport et Santé (EM2S), UR15JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax , Sfax , Tunisia.'}, {'ForeName': 'Hsen', 'Initials': 'H', 'LastName': 'Hsouna', 'Affiliation': 'Education, Motricité, Sport et Santé (EM2S), UR15JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax , Sfax , Tunisia.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Trabelsi', 'Affiliation': 'Education, Motricité, Sport et Santé (EM2S), UR15JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax , Sfax , Tunisia.'}, {'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke University , Magdeburg , Germany.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Taheri', 'Affiliation': 'Department of Sport Sciences, Faculty Of Social Sciences, Imam Khomeini International University , Qazvin , Iran.'}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Irandoust', 'Affiliation': 'Department of Sport Sciences, Faculty Of Social Sciences, Imam Khomeini International University , Qazvin , Iran.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hill', 'Affiliation': 'Applied Physiology Laboratory, Department of Kinesiology, Health Promotion, and Recreation, University of North Texas , Denton , Texas , USA.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': ""Institut Supérieur du Sport et de l'éducation physique de Sfax, Université de Sfax , Sfax , Tunisie.""}]",Chronobiology international,['10.1080/07420528.2019.1642908']
3133,31368382,Short and long-term effects of unguided internet-based cognitive behavioral therapy for chronic insomnia in morning and evening persons: a post-hoc analysis.,"A post-hoc analysis comparing morning and evening persons with insomnia on sleep and mental health characteristics was conducted in order to investigate whether an Internet-based cognitive behavioral therapy for insomnia (ICBTi) was effective both for morning and evening persons. Adult patients (N = 178, mean age = 44.8, 67% females) with insomnia were randomized to either ICBTi (N = 92; morning persons = 41; evening persons = 51) or a web-based patient education condition (N = 86; morning persons = 44; evening persons = 42). All patients were assessed with sleep diaries, the Insomnia Severity Index (ISI), the Bergen Insomnia Scale (BIS), the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16), the Hospital Anxiety and Depression Scale (HADS) and the Chalder Fatigue Scale (CFQ). Patients were characterized as morning or evening persons based on a median split on the Horne-Östberg Morningness Eveningness Questionnaire. Short and long-term effects of treatment were examined with mixed-model repeated-measures analyses. Morning and evening persons did not differ in terms of age, gender or educational status. At baseline, morning persons had more wake time after sleep onset ( d = 0.54,  p  < .001) and more early morning awakening ( d = 0.38,  p  < .05) compared to evening persons, while evening persons reported longer sleep onset latency ( d = 0.60,  p  < .001), more time in bed ( d = 0.56,  p  < .001), longer total sleep time ( d = 0.45,  p  < .01), more fatigue ( d = 0.31,  p  < .05) and more dysfunctional beliefs and attitudes about sleep ( d = 0.47,  p  < .01). Despite these differences at baseline, both morning and evening persons receiving ICBTi benefitted more across most measures compared to morning and evening persons who received patient education. For morning persons in the ICBTi group, ISI scores were reduced from 17.3 at baseline to 8.8 (d pre-post  = 2.48,  p  < .001) at post-assessment, and to 10.0 at 18-month follow up (d pre-post18m  = 2.13,  p  < .001). Comparable results were found for evening persons in the ICBTi group, with a reduction in ISI scores from 17.4 at baseline to 8.6 (d pre-post  = 2.24,  p  < .001) at post-assessment, and to 8.7 at 18-month follow up (d pre-post18m  = 2.19,  p  < .001). Similar results were found on the BIS, DBAS, HADS, CFQ and sleep diary data. Despite different insomnia symptomatology between the two groups, the current study suggests that ICBTi is effective across scores on the morningness-eveningness dimension. The study was pre-registered at: ClinicalTrials.gov Identifier: NCT02261272.",2019,"At baseline, morning persons had more wake time after sleep onset ( d = 0.54,  p  < .001) and more early morning awakening ( d = 0.38,  p  < .05) compared to evening persons, while evening persons reported longer sleep onset latency ( d = 0.60,  p  < .001), more time in bed ( d = 0.56,  p  < .001), longer total sleep time ( d = 0.45,  p  < .01), more fatigue ( d = 0.31,  p  < .05) and more dysfunctional beliefs and attitudes about sleep ( d = 0.47,  p  < .01).","['Adult patients (N = 178, mean age = 44.8, 67% females) with insomnia', 'chronic insomnia in morning and evening persons', 'Patients were characterized as morning or evening persons based on a median split on the Horne-Östberg Morningness Eveningness Questionnaire', 'persons with insomnia on sleep and mental health characteristics', 'N = 92; morning persons = 41; evening persons = 51) or a web-based patient education condition (N = 86; morning persons = 44; evening persons = 42']","['Internet-based cognitive behavioral therapy', 'unguided internet-based cognitive behavioral therapy', 'ICBTi']","['fatigue', 'dysfunctional beliefs and attitudes about sleep', 'early morning awakening', 'ISI scores', 'sleep diaries, the Insomnia Severity Index (ISI), the Bergen Insomnia Scale (BIS), the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16), the Hospital Anxiety and Depression Scale (HADS) and the Chalder Fatigue Scale (CFQ', 'BIS, DBAS, HADS, CFQ and sleep diary data', 'longer total sleep time', 'wake time after sleep onset', 'sleep onset latency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0541798', 'cui_str': 'Early Awakening'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0222045'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}]",,0.0479381,"At baseline, morning persons had more wake time after sleep onset ( d = 0.54,  p  < .001) and more early morning awakening ( d = 0.38,  p  < .05) compared to evening persons, while evening persons reported longer sleep onset latency ( d = 0.60,  p  < .001), more time in bed ( d = 0.56,  p  < .001), longer total sleep time ( d = 0.45,  p  < .01), more fatigue ( d = 0.31,  p  < .05) and more dysfunctional beliefs and attitudes about sleep ( d = 0.47,  p  < .01).","[{'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lien', 'Affiliation': 'Department of Psychosocial Science, University of Bergen , Bergen , Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Bredeli', 'Affiliation': 'Department of Psychosocial Science, University of Bergen , Bergen , Norway.'}, {'ForeName': 'Børge', 'Initials': 'B', 'LastName': 'Sivertsen', 'Affiliation': 'Department of Health Promotion, Norwegian Institute of Public Health , Bergen , Norway.'}, {'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Kallestad', 'Affiliation': 'Division of Mental Health Care, Department of Østmarka, St. Olavs University Hospital , Trondheim , Norway.'}, {'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Pallesen', 'Affiliation': 'Department of Psychosocial Science, University of Bergen , Bergen , Norway.'}, {'ForeName': 'Otto R F', 'Initials': 'ORF', 'LastName': 'Smith', 'Affiliation': 'Department of Health Promotion, Norwegian Institute of Public Health , Bergen , Norway.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Faaland', 'Affiliation': 'Division of Mental Health Care, Department of Østmarka, St. Olavs University Hospital , Trondheim , Norway.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Ritterband', 'Affiliation': 'Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia Health System , Charlottesville , VA , USA.'}, {'ForeName': 'Frances P', 'Initials': 'FP', 'LastName': 'Thorndike', 'Affiliation': 'Pear Therapeutics , Boston , MA , USA.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Vedaa', 'Affiliation': 'Department of Health Promotion, Norwegian Institute of Public Health , Bergen , Norway.'}]",Chronobiology international,['10.1080/07420528.2019.1647435']
3134,31152113,Exposure to incivility hinders clinical performance in a simulated operative crisis.,"BACKGROUND


Effective communication is critical for patient safety. One potential threat to communication in the operating room is incivility. Although examined in other industries, little has been done to examine how incivility impacts the ability to deliver safe care in a crisis. We therefore sought to determine how incivility influenced anaesthesiology resident performance during a standardised simulation scenario of occult haemorrhage.
METHODS


This is a multicentre, prospective, randomised control trial from three academic centres. Anaesthesiology residents were randomly assigned to either a normal or 'rude' environment and subjected to a validated simulated operating room crisis. Technical and non-technical performance domains including vigilance, diagnosis, communication and patient management were graded on survey with Likert scales by blinded raters and compared between groups.
RESULTS


76 participants underwent randomisation with 67 encounters included for analysis (34 control, 33 intervention). Those exposed to incivility scored lower on every performance metric, including a binary measurement of overall performance with 91.2% (control) versus 63.6% (rude) obtaining a passing score (p=0.009). Binary logistic regression to predict this outcome was performed to assess impact of confounders. Only the presence of incivility reached statistical significance (OR 0.110, 95% CI 0.022 to 0.544, p=0.007). 65% of the rude group believed the surgical environment negatively impacted performance; however, self-reported performance assessment on a Likert scale was similar between groups (p=0.112).
CONCLUSION


Although self-assessment scores were similar, incivility had a negative impact on performance. Multiple areas were impacted including vigilance, diagnosis, communication and patient management even though participants were not aware of these effects. It is imperative that these behaviours be eliminated from operating room culture and that interpersonal communication in high-stress environments be incorporated into medical training.",2019,"Multiple areas were impacted including vigilance, diagnosis, communication and patient management even though participants were not aware of these effects.","['Anaesthesiology residents', '76 participants underwent randomisation with 67 encounters included for analysis (34 control, 33 intervention']","[""normal or 'rude' environment and subjected to a validated simulated operating room crisis""]","['surgical environment negatively impacted performance; however, self-reported performance assessment on a Likert scale', 'vigilance, diagnosis, communication and patient management']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",76.0,0.053593,"Multiple areas were impacted including vigilance, diagnosis, communication and patient management even though participants were not aware of these effects.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Katz', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, New York City, New York, USA daniel.katz@mountsinai.org.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Blasius', 'Affiliation': 'Anesthesiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Isaak', 'Affiliation': 'Anesthesiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lipps', 'Affiliation': 'Anesthesiology, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kushelev', 'Affiliation': 'Anesthesiology, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goldberg', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Jarrett', 'Initials': 'J', 'LastName': 'Fastman', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Marsh', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'DeMaria', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}]",BMJ quality & safety,['10.1136/bmjqs-2019-009598']
3135,32438543,Silicone Implant Versus Silicone Implant Assisted by Stromal Enriched Lipograft Breast Augmentation: A Prospective Comparative Study.,"Background:  Implant-assisted breast augmentation is among the most performed surgeries performed by plastic surgeons today. This prospective study evaluated the patient satisfaction and complication rates using high-profile round silicone implant alone (traditional breast augmentation) Group A versus the high-profile round silicone implant assisted with stromal enriched lipograft (composite breast augmentation) Group B.  Methods:  A total of 50 female patient candidates to undergo breast augmentation between January to September 2017 were randomly assigned to either group. The periareolar technique for breast augmentation and the subfascial plane were used in both groups for the insertion of the high-profile round silicone implants. The stromal enriched lipograft (SEL) was used in Group B for the preparation of the autologous fat grafting to the breast. The satisfaction of each patient with body appearance following breast augmentation was rated using an already published scale of 1-5. The rate of complications was analysed.  Results:  AS performed all the surgeries. In Group A, the age range was between 19 and 48 years (mean of 22.5 years). In Group B, the age range was between 20 and 47 years (mean of 24.1 years). The average BMI of Group A was 24 m/kg 2  and 23 m/kg 2  of Group B. Patient satisfaction meta-analysis for Group A and B at 12 months shows that patients in Group B expressed a satisfaction that is superior when compared to Group A patients. The ability to camouflage the implant could explain the higher satisfaction rates in Group B. The rate of complications appears similar in both groups.  Conclusions:  Composite breast augmentation using a combination of round high-profile implants and SEL in breast augmentation can achieve a higher patient satisfaction and aesthetic outcome as compared to the round high-profile breast augmentation alone. The technique is safe, simple and fast with low complication rates. Large multicentre, controlled, prospective studies need to be performed to further confirm the favourable results that were observed in this study.",2020,The rate of complications appears similar in both groups.  ,"['50 female patient candidates to undergo breast augmentation between January to September 2017', 'In Group A, the age range was between 19 and 48 years (mean of 22.5 years']","['Composite breast augmentation using a combination of round high-profile implants and SEL', 'high-profile round silicone implant assisted with stromal enriched lipograft (composite breast augmentation', 'high-profile round silicone implant alone (traditional breast augmentation', 'Silicone Implant Versus Silicone Implant Assisted by Stromal Enriched Lipograft Breast Augmentation', ':  Implant-assisted breast augmentation']","['patient satisfaction and complication rates', 'rate of complications', 'satisfaction rates', 'average BMI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517649', 'cui_str': '22.5'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0574702', 'cui_str': 'Selkup language'}, {'cui': 'C1289793', 'cui_str': 'Silicone implant'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0234892,The rate of complications appears similar in both groups.  ,"[{'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Sterodimas', 'Affiliation': 'Plastic & Reconstructive Surgery Department, Metropolitan General Hospital, 264 Mesogeion Avenue, 15562 Athens, Greece.'}]","Medicines (Basel, Switzerland)",['10.3390/medicines7050028']
3136,32437567,"Synergistic Effect of Biejia-Ruangan on Fibrosis Regression in Patients with Chronic Hepatitis B Treated with Entecavir: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial.","BACKGROUND AND AIMS


Long-term nucleos(t)ide analogues (NAs) treatment can reverse liver fibrosis in chronic hepatitis B (CHB), but its effect on fibrosis regression remains limited. Biejia-Ruangan (BR) has been approved in China as an anti-fibrotic traditional Chinese medicine drug in patients with chronic liver diseases. A multicenter randomized controlled trial aims to evaluate the effect of BR on fibrosis regression in CHB patients treated with NAs.
METHODS


CHB patients with histologically confirmed advanced fibrosis or cirrhosis were randomly assigned to receive entecavir (ETV) (0.5mg per day) plus BR (2g three times a day) or placebo for 72 weeks. Liver fibrosis regression was defined as a reduction of ≥1 point by the Ishak Fibrosis Stage (IFS).
RESULTS


Overall, 500 patients were enrolled in each group as the intention-to-treat population. The rate of fibrosis regression after 72 week treatment was significantly higher in ETV+BR group (40% versus 31.8%, P=0.0069). Among 388 patients with cirrhosis (i.e., IFS ≥5) at baseline, the rate of cirrhosis reversal (i.e., IFS ≤4) was significantly higher in ETV+BR group (41.5% versus 30.7%, P=0.0103).
CONCLUSIONS


Addition of BR to the current standard treatment with NAs in CHB patients with advanced fibrosis or cirrhosis can improve liver fibrosis regression.",2020,"The rate of fibrosis regression after 72 week treatment was significantly higher in ETV+BR group (40% versus 31.8%, P=0.0069).","['CHB patients with advanced fibrosis or cirrhosis', 'CHB patients with histologically confirmed advanced fibrosis or cirrhosis', 'CHB patients treated with NAs', '388 patients with cirrhosis', 'patients with chronic liver diseases', 'Patients with Chronic Hepatitis B Treated with', 'chronic hepatitis B (CHB', '500 patients were enrolled in each group as the intention-to-treat population']","['Placebo', 'Biejia-Ruangan (BR', 'Entecavir', 'ETV+BR', 'Biejia-Ruangan', 'entecavir (ETV', 'placebo']","['rate of fibrosis regression', 'Fibrosis Regression', 'fibrosis regression', 'rate of cirrhosis reversal', 'Liver fibrosis regression']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4041863', 'cui_str': 'biejia ruangan'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}]","[{'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}]",500.0,0.265692,"The rate of fibrosis regression after 72 week treatment was significantly higher in ETV+BR group (40% versus 31.8%, P=0.0069).","[{'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Rong', 'Affiliation': 'Department of Liver Diseases of Chinese PLA General Hospital, the Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yongping', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious and Liver Diseases, Liver Research Center, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China.'}, {'ForeName': 'Zujiang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Infectious Disease, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Fuzhou Infectious Diseases Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Jingfeng', 'Initials': 'J', 'LastName': 'Bi', 'Affiliation': 'Department of Clinical & Translational Medicine, the Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': ""Liver Disease Department, Fuyang 2nd People's Hospital, Fuyang, Anhui Province, China.""}, {'ForeName': 'Dedong', 'Initials': 'D', 'LastName': 'Xiang', 'Affiliation': 'Department of Infectious Diseases, Southwest Hospital, the Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Shang', 'Affiliation': 'Therapeutic Center for Liver Disease, the 88th Hospital of PLA, Taian, Shandong Province, China.'}, {'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Lei', 'Affiliation': ""Guangzhou 8th People's Hospital, Guangzhou, Guangdong Province, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Hepatic Diseases, Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'National Integrative Medicine Clinical Base for Infectious Diseases and Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, Sichuan Province, China.'}, {'ForeName': 'Huabao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Traditional Chinese Medicine Hospital of Chongqing, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ""Tianjin Second People's Hospital, Tianjin Institute of Hepatology, Tianjin, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Liver Diseases of Chinese PLA General Hospital, the Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Liver Diseases of Chinese PLA General Hospital, the Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wenlin', 'Initials': 'W', 'LastName': 'Bai', 'Affiliation': 'Department of Liver Diseases of Chinese PLA General Hospital, the Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Yoshida', 'Affiliation': 'Division of Gastroenterology, Vancouver General Hospital, Vancouver, British Columbia, V6T1Z4 Canada.'}, {'ForeName': 'Nahum', 'Initials': 'N', 'LastName': 'Mendez-Sanchez', 'Affiliation': 'Liver Research Unit Medica Sur Clinic & Foundation & Faculty of Medicine, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Ke-Qin', 'Initials': 'KQ', 'LastName': 'Hu', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of California, Irvine, School of Medicine, Orange, CA, USA.'}, {'ForeName': 'Xingshun', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Gastroenterology, General Hospital of Northern Theater Command (formerly General Hospital of Shenyang Military Area), Shenyang, Liaoning Province, China.'}, {'ForeName': 'Yongping', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Liver Diseases of Chinese PLA General Hospital, the Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa266']
3137,31425751,"A randomized pragmatic clinical trial of gestational diabetes screening (ScreenR2GDM): Study design, baseline characteristics, and protocol adherence.","BACKGROUND


ScreenR2GDM is a pragmatic randomized clinical trial designed to investigate if one of two gestational diabetes (GDM) screening and treatment protocols results in improved outcomes in the context of standard clinical care.
METHODS


Pregnant women are randomized to one of two GDM screening strategies: 1-step: 2-h, 75 g, oral glucose tolerance test (OGTT) or 2-step: 1-h, 50 g glucose challenge test (GCT) followed by 3-h, 100 g OGTT if GCT-positive. Providers are prompted within the electronic medical record to order the assigned test but were given the option to order the alternate test. Collected data include maternal and pregnancy characteristics, GDM testing, and outcomes for mother and newborn. We describe the study design and baseline characteristics and evaluate characteristics associated with adhering to the randomized protocol.
RESULTS


Baseline characteristics of the 23,792 randomized pregnancies were comparable between the two groups. Adherence to assigned test differed between the two strategies: 66.1% for 1-step and 91.7% for 2-step (p < .0001). 27% of the women randomized to receive the 1-step completed the 2-step test vs 2% randomized to the 2-step who completed the 1-step (p < .0001). Patient characteristics related to adherence included obesity, age, prior GDM, Medicaid insurance, race and nulliparity. Clinician characteristics related to adherence included provider type, age and gender.
CONCLUSIONS


Both patient and provider characteristics were related to adherence to the randomized GDM screening protocol. Analytical techniques that incorporate these findings into the formal evaluation of the two protocols on GDM-associated outcomes will be necessary to account for potential biases introduced by non-adherence.",2019,Adherence to assigned test differed between the two strategies: 65.9% for 1-step and 90.5% for 2-step (p < .0001).,['Pregnant women'],"['GDM screening strategies: 1-step: 2-h, 75\u202fg, oral glucose tolerance test (OGTT) or 2-step: 1-h, 50\u202fg glucose challenge test (GCT', 'gestational diabetes screening (ScreenR2GDM']","['maternal and pregnancy characteristics, GDM testing, and outcomes for mother and newborn']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0017741', 'cui_str': 'Glucose tolerance test (procedure)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]",,0.130347,Adherence to assigned test differed between the two strategies: 65.9% for 1-step and 90.5% for 2-step (p < .0001).,"[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Pedula', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: kathy.pedula@kp.org.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Hillier', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: teresa.hillier@kpchr.org.'}, {'ForeName': 'Keith K', 'Initials': 'KK', 'LastName': 'Ogasawara', 'Affiliation': 'Department of Obstetrics & Gynecology, Hawaii Permanente Medical Group, Kaiser Permanente, 3288 Moanalua Road, Honolulu, HI 96819, USA. Electronic address: keith.k.ogasawara@kp.org.'}, {'ForeName': 'Kimberly K', 'Initials': 'KK', 'LastName': 'Vesco', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: kimberly.k.vesco@kpchr.org.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Lubarsky', 'Affiliation': 'Department of Perinatology, Northwest Permanente, Kaiser Permanente, 10180 SE Sunnyside Rd, Clackamas, OR 97015, USA. Electronic address: suzanne.l.lubarsky@kp.org.'}, {'ForeName': 'Caryn E S', 'Initials': 'CES', 'LastName': 'Oshiro', 'Affiliation': 'Center for Health Research, Kaiser Permanente Hawaii, 501 Alakawa St, Suite 201, Honolulu, HI 96817, USA. Electronic address: caryn.es.oshiro@kp.org.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'VanMarter', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: jan.vanmarter@kpchr.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105829']
3138,32438531,Intermittent Fasting Does Not Uniformly Impact Genes Involved in Circadian Regulation in Women with Obesity.,"OBJECTIVE


This study aimed to examine the effects of intermittent fasting (IF) on mRNA levels of peripheral clock genes in skeletal muscle and subcutaneous adipose tissue (SAT) in women with obesity.
METHODS


Women were randomized to one of two IF protocols and provided with all foods at 100% or 70% of calculated weekly energy requirements for 8 weeks. Breakfast was consumed before a 24-hour fast, which was initiated on 3 nonconsecutive days/week. Muscle and SAT biopsies were performed at 8 am after an overnight fast at baseline and at week 8 on a refed day and again following a 24-hour fasting at week 8 for analysis of the mRNA levels of key genes involved in circadian regulation.
RESULTS


A group-by-time interaction was observed in Per2 in muscle (F = 3.497, P = 0.044) and SAT (F = 6.686, P = 0.008), but significance was lost upon post hoc adjustment. A time effect was observed in Rorα in muscle, which was decreased by refeeding in both groups (F = 7.225, P = 0.003).
CONCLUSIONS


There was no universal effect of IF to alter peripheral clocks, which may partly be due to the alignment of the fasting/feeding cycle with the biological clock. Optimizing intermittent fasting protocols could be important to prevent circadian misalignment in humans.",2020,"RESULTS


A group-by-time interaction was observed in Per2 in muscle (F = 3.497, P = 0.044) and SAT (F = 6.686, P = 0.008), but significance was lost upon post hoc adjustment.","['women with obesity', 'Women with Obesity', 'Women']",['intermittent fasting (IF'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}]",[],,0.0900366,"RESULTS


A group-by-time interaction was observed in Per2 in muscle (F = 3.497, P = 0.044) and SAT (F = 6.686, P = 0.008), but significance was lost upon post hoc adjustment.","[{'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Hutchison', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Wittert', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Campbell H', 'Initials': 'CH', 'LastName': 'Thompson', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Leonie K', 'Initials': 'LK', 'LastName': 'Heilbronn', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22775']
3139,32438535,Comparison of Physiotherapy Approaches in Low Back Pain: A Randomized Controlled Trial.,"Background


The purpose of this study was to compare the effectiveness of rehabilitation approaches in individuals with low back pain (LBP) on pain, spinal mobility, disability, and muscular strength.
Methods


Ninety volunteers were included and divided into four groups depending on the rehabilitation approach. Group 1, soft tissue mobilization techniques and stabilization exercises (n=24; 11 females (F), 13 males (M); group 2, Kinesio Taping and stabilization exercises (n=24; 12F, 12M); group 3, stabilization exercises (n=22; 11F, 11M); and group 4, reflex therapy and stabilization exercises (n=20; 10F, 10M). Visual Analog Scale for pain intensity, an isokinetic evaluation for strength at 60°/s and a side-plank position test for trunk stabilization were measured before and assessed at the beginning, after a 4-week treatment and during 4 weeks of follow-up. The functional status was evaluated with the Oswestry Disability Index.
Results


Individuals in all groups showed similar decrease in pain after the treatment and at 1-month follow-up, but there were no significant differences in pain levels between the groups (P<0.05).
Conclusion


All therapeutic approaches were found to be effective in diminishing pain and thus helpful in increasing strength and stabilization in patients with LBP.",2020,"Individuals in all groups showed similar decrease in pain after the treatment and at 1-month follow-up, but there were no significant differences in pain levels between the groups (P<0.05).
","['at 60°', 'Low Back Pain', 'Methods\n\n\nNinety volunteers', 'individuals with low back pain (LBP', 'n=24; 11 females (F), 13 males (M); group 2', 'patients with LBP']","['soft tissue mobilization techniques and stabilization exercises ', 'Kinesio Taping and stabilization exercises', 'stabilization exercises', 'reflex therapy and stabilization exercises', 'Physiotherapy Approaches']","['pain, spinal mobility, disability, and muscular strength', 'Visual Analog Scale for pain intensity, an isokinetic evaluation for strength', 'pain levels', 'pain', 'Oswestry Disability Index']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0686940', 'cui_str': 'Soft tissue mobilization'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034946', 'cui_str': 'Reflex Therapy'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",90.0,0.032159,"Individuals in all groups showed similar decrease in pain after the treatment and at 1-month follow-up, but there were no significant differences in pain levels between the groups (P<0.05).
","[{'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Senbursa', 'Affiliation': 'Anima Rapha Center of Manual Therapy and Reflexology, Ankara, Turkey.'}, {'ForeName': 'Nihan Ozunlu', 'Initials': 'NO', 'LastName': 'Pekyavas', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Gul', 'Initials': 'G', 'LastName': 'Baltaci', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Private Guven Hospital, Ankara, Turkey.'}]",Korean journal of family medicine,['10.4082/kjfm.20.0025']
3140,32438624,"Effect of Supplementation with  Saccharomyces Boulardii  on Academic Examination Performance and Related Stress in Healthy Medical Students: A Randomized, Double-Blind, Placebo-Controlled Trial.","In recent years, bacterial probiotic dietary supplementation has emerged as a promising way to improve cognition and to alleviate stress and anxiety; however, yeast probiotics have not been tested. The aim of the present study was to determine whether 30-day supplementation with  Saccharomyces boulardii  enhances academic performance under stress and affects stress markers. The trial was retrospectively registered at clinicaltrials.gov (NCT03427515). Healthy medical students were randomized to supplement their diet with  Saccharomyces boulardii  CNCM I-1079 or placebo before sitting for an academic examination, which served as a model of stress. The grades of a final examination adjusted to subject knowledge tested in non-stressful conditions was used as a primary outcome measure. Psychometrically evaluated state anxiety, cortisol and metanephrine salivary levels, and pulse rate were tested at a non-stressful time point before the intervention as well as just before the stressor. Fifty enrolled participants (22.6 ± 1.4 years of age, 19 males) completed the trial in the  Saccharomyces  and placebo arms. Supplementation with  Saccharomyces  did not significantly modify examination performance or increase in state anxiety, salivary cortisol, and metanephrine. However, the intervention resulted in higher increase in pulse rate under stress as compared to placebo by 10.4 (95% CI 4.2-16.6) min -1  ( p  = 0.0018), and the effect positively correlated with increase in salivary metanephrine (Pearson's r = 0.35, 95% CI 0.09-0.58,  p  = 0.012). An  intention-to-treat  analysis was in line with the  per-protocol  one. In conclusion, supplementation with  Saccharomyces boulardii  CNCM I-1079 appears largely ineffective in improving academic performance under stress and in alleviating some stress markers, but it seems to increase pulse rate under stress, which may hypothetically reflect enhanced sympathoadrenal activity.",2020,"Supplementation with  Saccharomyces  did not significantly modify examination performance or increase in state anxiety, salivary cortisol, and metanephrine.","['Healthy medical students', 'Fifty enrolled participants (22.6 ± 1.4 years of age, 19 males) completed the trial in the  Saccharomyces  and placebo arms', 'Healthy Medical Students']","['Saccharomyces boulardii', 'Placebo', 'Supplementation with  Saccharomyces Boulardii', 'supplement their diet with  Saccharomyces boulardii  CNCM I-1079 or placebo', 'placebo']","['state anxiety, salivary cortisol, and metanephrine', 'pulse rate under stress', 'examination performance', 'Academic Examination Performance and Related Stress', 'state anxiety, cortisol and metanephrine salivary levels, and pulse rate', 'salivary metanephrine']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036024', 'cui_str': 'Saccharomyces'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0772093', 'cui_str': 'Saccharomyces boulardii'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0025562', 'cui_str': 'Metanephrine'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",50.0,0.441354,"Supplementation with  Saccharomyces  did not significantly modify examination performance or increase in state anxiety, salivary cortisol, and metanephrine.","[{'ForeName': 'Michał Seweryn', 'Initials': 'MS', 'LastName': 'Karbownik', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Lodz, Żeligowskiego 7/9, 90-752 Łódź, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Kręczyńska', 'Affiliation': 'Department of Infectious Diseases and Hepatology, Medical University of Lodz, Kniaziewicza 1/5, 91-347 Łódź, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Kwarta', 'Affiliation': 'Department of Pediatrics and Allergy, Copernicus Memorial Hospital in Łódź, Medical University of Lodz, Piłsudskiego 71, 90-329 Łódź, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Cybula', 'Affiliation': 'Oklahoma Medical Research Foundation, Aging and Metabolism Program, 825 NE 13th St, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wiktorowska-Owczarek', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Lodz, Żeligowskiego 7/9, 90-752 Łódź, Poland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Kowalczyk', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Lodz, Żeligowskiego 7/9, 90-752 Łódź, Poland.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Pietras', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Lodz, Kopcińskiego 22, 90-153 Łódź, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Szemraj', 'Affiliation': 'Department of Medical Biochemistry, Medical University in Lodz, Mazowiecka 6/8, 92-215 Łódź, Poland.'}]",Nutrients,['10.3390/nu12051469']
3141,32437664,"First-line pembrolizumab and trastuzumab in HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer: an open-label, single-arm, phase 2 trial.","BACKGROUND


Addition of trastuzumab to first-line chemotherapy improves overall survival in patients with HER2-positive metastatic gastric cancer. We assessed the safety and activity of pembrolizumab in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic oesophagogastric (gastric, oesophageal, or gastroesophageal junction) cancer.
METHODS


This study was an investigator-initiated, open-label, non-randomised, single-arm, single centre, phase 2 trial in patients aged 18 years or older with HER2-positive metastatic oesophagogastric cancer. Eligible patients had measurable or evaluable non-measurable disease, Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and left ventricular ejection fraction of at least 53%. Patients were eligible to receive an initial induction cycle of 200 mg flat dose of intravenous pembrolizumab and 8 mg/kg loading dose of intravenous trastuzumab. For subsequent cycles, patients received 130 mg/m 2  of intravenous oxaliplatin or 80 mg/m 2  of cisplatin on day 1, 850 mg/m 2  of oral capecitabine twice a day for 2 weeks followed by 1 week off (or intravenous 5-fluorouracil, 800 mg/m 2  per day on days 1-5), and a 200 mg flat dose of intravenous pembrolizumab, and 6 mg/kg of trastuzumab, administered on day 1 of each 3-week cycle. The primary endpoint was 6-month progression-free survival, defined as the proportion of patients alive and free of progression at 6 months, assessed in patients who received at least one dose of trastuzumab and pembrolizumab. The regimen would be considered worthy of further investigation if 26 or more of 37 patients were progression-free at 6 months. This trial is registered with ClinicalTrials.gov, NCT02954536, and is ongoing, but closed to enrolment.
FINDINGS


Between Nov 11, 2016, and Jan 23, 2019, 37 patients were enrolled. At the time of data cutoff on Aug 6, 2019, median follow-up among survivors was 13·0 months (IQR 11·7-23·5). The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months. The most common treatment-related adverse event of any grade was neuropathy, which was reported in 36 (97%) of 37 patients. The most common grade 3 or 4 adverse events were lymphocytopenia (seven [19%] patients with grade 3 and two [5%] with grade 4), grade 3 decreased electrolytes (six [16%] patients), and grade 3 anaemia (four [11%] patients). Serious adverse events occurred in two patients patients (both grade 3 nephritis leading to treatment discontinuation). Four patients discontinued pembrolizumab because of immune-related adverse events. There were no treatment-related deaths.
INTERPRETATION


Pembrolizumab can be safely combined with trastuzumab and chemotherapy and has promising activity in HER2-positive metastatic oesophagogastric cancer. A randomised phase 3 clinical trial assessing the efficacy and safety of pembrolizumab versus placebo in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic oesophagogastric cancer is underway.
FUNDING


Merck & Co.",2020,The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months.,"['HER2-positive metastatic oesophagogastric cancer', 'Eligible patients had measurable or evaluable non-measurable disease, Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and left ventricular ejection fraction of at least 53', 'patients aged 18 years or older with HER2-positive metastatic oesophagogastric cancer', 'first-line HER2-positive metastatic oesophagogastric cancer', 'HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer', 'Between Nov 11, 2016, and Jan 23, 2019, 37 patients were enrolled', 'first-line HER2-positive metastatic oesophagogastric (gastric, oesophageal, or gastroesophageal junction) cancer', 'patients with HER2-positive metastatic gastric cancer']","['oxaliplatin', 'intravenous pembrolizumab and 8 mg/kg loading dose of intravenous trastuzumab', 'trastuzumab and pembrolizumab', 'trastuzumab to first-line chemotherapy', 'trastuzumab and chemotherapy', 'capecitabine', 'cisplatin', 'pembrolizumab, and 6 mg/kg of trastuzumab', 'pembrolizumab versus placebo', 'First-line pembrolizumab and trastuzumab', '5-fluorouracil', 'pembrolizumab']","['safety and activity', '6-month progression-free survival, defined as the proportion of patients alive and free of progression', 'overall survival', 'grade 3 decreased electrolytes', 'grade 3 anaemia', 'efficacy and safety', 'Serious adverse events']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0278498', 'cui_str': 'Gastric cancer stage IV'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0740464', 'cui_str': 'Electrolytes NOS decreased'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",37.0,0.193351,The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months.,"[{'ForeName': 'Yelena Y', 'Initials': 'YY', 'LastName': 'Janjigian', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA. Electronic address: janjigiy@mskcc.org.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Maron', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Walid K', 'Initials': 'WK', 'LastName': 'Chatila', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Tri-Institutional Program in Computational Biology and Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Brittanie', 'Initials': 'B', 'LastName': 'Millang', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Shweta S', 'Initials': 'SS', 'LastName': 'Chavan', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Alterman', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Chou', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Michal F', 'Initials': 'MF', 'LastName': 'Segal', 'Affiliation': 'Department of Nursing, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marc Z', 'Initials': 'MZ', 'LastName': 'Simmons', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Momtaz', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Shcherba', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Geoffrey Y', 'Initials': 'GY', 'LastName': 'Ku', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Zervoudakis', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Won', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kelsen', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Ilson', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Nagy', 'Affiliation': 'Guardant Health, Redwood City, CA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lanman', 'Affiliation': 'Guardant Health, Redwood City, CA, USA.'}, {'ForeName': 'Ryan N', 'Initials': 'RN', 'LastName': 'Ptashkin', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark T A', 'Initials': 'MTA', 'LastName': 'Donoghue', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marinela', 'Initials': 'M', 'LastName': 'Capanu', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Taylor', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Solit', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Schultz', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jaclyn F', 'Initials': 'JF', 'LastName': 'Hechtman', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30169-8']
3142,31030995,A Pooled Analysis of the Safety and Efficacy of Iclaprim Versus Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Patients With Intravenous Drug Use: Phase 3 REVIVE Studies.,"PURPOSE


This analysis evaluates the efficacy and safety of iclaprim versus vancomycin for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) in patients who were intravenous drug users (IVDUs).
METHODS


A total of 621 patients who were IVDUs from 2 parallel Phase III, double-blind, randomized (1:1), active-controlled, multinational, multicenter trials (REVIVE-1 and REVIVE-2) were analyzed separately and pooled. This post hoc analysis summarizes the efficacy and safety profile of iclaprim 80 mg fixed dose compared with vancomycin 15 mg/kg administered intravenously during 2 h every 12 h for 5-14 days among this population. The primary end point of these studies was to determine whether iclaprim was noninferior (10% margin) to vancomycin in achieving a ≥20% reduction in lesion size at 48-72 h after initiation of treatment with the study drug (early clinical response) in the intent-to-treat population. The safety profile was assessed based on adverse events and laboratory parameters.
FINDINGS


Iclaprim had higher early clinical response rates (85.8%; 95% CI, 81.5%-89.4%) compared with vancomycin (79.8%; 95% CI, 74.8%-84.2%) among patients with ABSSSIs who were IVDUs, with a treatment difference of +6.00% (95% CI, 0.06-12.0). The safety profile was similar in the iclaprim and vancomycin arms, with 3.7% and 5.0%, respectively, of patients discontinuing study therapy because of adverse events and 1.9% and 3.4%, respectively, of patients developing serious adverse events.
IMPLICATIONS


Iclaprim had a higher early clinical response rate and favorable safety profile compared with vancomycin for the treatment of ABSSSIs in patients who were IVDUs. Iclaprim may be a valuable treatment option for ABSSSIs in this patient population.",2019,"FINDINGS


Iclaprim had higher early clinical response rates (85.8%; 95% CI, 81.5%-89.4%) compared with vancomycin (79.8%; 95% CI, 74.8%-84.2%) among patients with ABSSSIs who were IVDUs, with a treatment difference of +6.00% (95% CI, 0.06-12.0).","['patients who were IVDUs', 'Patients With Intravenous Drug Use', '621 patients who were IVDUs from 2 parallel Phase III', 'patients who were intravenous drug users (IVDUs']","['Iclaprim Versus Vancomycin', 'Iclaprim', 'vancomycin', 'iclaprim versus vancomycin', 'iclaprim']","['Acute Bacterial Skin and Skin Structure Infections', 'early clinical response rates', 'lesion size', 'safety profile', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0242566', 'cui_str': 'Intravenous drug user (finding)'}]","[{'cui': 'C1452002', 'cui_str': 'iclaprim'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}]","[{'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",621.0,0.232032,"FINDINGS


Iclaprim had higher early clinical response rates (85.8%; 95% CI, 81.5%-89.4%) compared with vancomycin (79.8%; 95% CI, 74.8%-84.2%) among patients with ABSSSIs who were IVDUs, with a treatment difference of +6.00% (95% CI, 0.06-12.0).","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Huang', 'Affiliation': 'Motif BioSciences, Princeton, NJ, USA; Rutgers New Jersey Medical School, Trenton, NJ, USA. Electronic address: david.huang@motifbio.com.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Noviello', 'Affiliation': 'Motif BioSciences, Princeton, NJ, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Balser', 'Affiliation': 'Veristat, Southborough, MA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Scaramucci', 'Affiliation': 'Veristat, Southborough, MA, USA.'}, {'ForeName': 'G Ralph', 'Initials': 'GR', 'LastName': 'Corey', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.04.004']
3143,31427751,"Effects of immunomodulatory drugs on depressive symptoms: A mega-analysis of randomized, placebo-controlled clinical trials in inflammatory disorders.","Activation of the innate immune system is commonly associated with depression. Immunomodulatory drugs may have efficacy for depressive symptoms that are co-morbidly associated with inflammatory disorders. We report a large-scale re-analysis by standardized procedures (mega-analysis) of patient-level data combined from 18 randomized clinical trials conducted by Janssen or GlaxoSmithKline for one of nine disorders (N = 10,743 participants). Core depressive symptoms (low mood, anhedonia) were measured by the Short Form Survey (SF-36) or the Hospital Anxiety and Depression Scale (HADS), and participants were stratified into high (N = 1921) versus low-depressive strata based on baseline ratings. Placebo-controlled change from baseline after 4-16 weeks of treatment was estimated by the standardized mean difference (SMD) over all trials and for each subgroup of trials targeting one of 7 mechanisms (IL-6, TNF-α, IL-12/23, CD20, COX2, BLγS, p38/MAPK14). Patients in the high depressive stratum showed modest but significant effects on core depressive symptoms (SMD = 0.29, 95% CI [0.12-0.45]) and related SF-36 measures of mental health and vitality. Anti-IL-6 antibodies (SMD = 0.8, 95% CI [0.20-1.41]) and an anti-IL-12/23 antibody (SMD = 0.48, 95% CI [0.26-0.70]) had larger effects on depressive symptoms than other drug classes. Adjustments for physical health outcome marginally attenuated the average treatment effect on depressive symptoms (SMD = 0.20, 95% CI: 0.06-0.35), but more strongly attenuated effects on mental health and vitality. Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment. Novel immune-therapeutics can produce antidepressant effects in depressed patients with primary inflammatory disorders that are not entirely explained by treatment-related changes in physical health.",2020,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"['depressed patients with primary inflammatory disorders', 'for one of nine disorders (N\u2009=\u200910,743 participants']","['Placebo', 'placebo', 'immunomodulatory drugs', 'Janssen or GlaxoSmithKline']","['depressive symptoms', 'Anti-IL-6 antibodies', 'mental health and vitality', 'core depressive symptoms', 'related SF-36 measures of mental health and vitality', 'Core depressive symptoms (low mood, anhedonia', 'Hospital Anxiety and Depression Scale (HADS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1290884', 'cui_str': 'Inflammatory disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]",,0.398153,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"[{'ForeName': 'Gayle M', 'Initials': 'GM', 'LastName': 'Wittenberg', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA. gwittenb@its.jnj.com.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Stylianou', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Jagannatha', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hsu', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Curran', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Bullmore', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0471-8']
3144,32438483,Telemonitoring versus standard of care in heart failure: a randomised multicentre trial.,"AIMS


The aim was to assess the effect of a telemonitoring programme versus standard care (SC) in preventing all-cause deaths or unplanned hospitalisations in heart failure (HF) at 18 months.
METHODS AND RESULTS


OSICAT was a randomised, multicentre, open-label French study in 937 patients hospitalised for acute HF ≤12 months before inclusion. Patients were randomised to telemonitoring (daily body-weight measurement, daily recording of HF symptoms, and personalised education) (n = 482) or to SC (n = 455). Mean ± standard deviation number of events for the primary outcome was 1.30 ± 1.85 for telemonitoring and 1.46 ± 1.98 for SC (rate ratio 0.97, 95% CI 0.77-1.23; P = 0.80). In NYHA class III or IV HF, median time to all-cause death or first unplanned hospitalisation was 82 days in the telemonitoring group and 67 days in the SC group (P = 0.03). After adjustment for known predictive factors, telemonitoring was associated with a 21% relative risk reduction in first unplanned hospitalisation for HF (hazard ratio [HR] 0.79, 95% CI 0.62-0.99; P = 0.044); the relative risk reduction was 29% in patients with NYHA class III or IV HF (HR 0.71, 95% CI 0.53-0.95; P = 0.02), 38% in socially isolated patients (HR 0.62, 95% CI 0.39-0.98; P = 0.043), and 37% in patients who were ≥ 70% adherent to body-weight measurement (HR 0.63, 95% CI 0.45-0.88; P = 0.006).
CONCLUSION


Telemonitoring did not result in a significantly lower rate of all-cause deaths or unplanned hospitalisations in HF patients. The pre-specified subgroup results suggest the telemonitoring approach improves clinical outcomes in selected populations but need further confirmation. This article is protected by copyright. All rights reserved.",2020,Telemonitoring did not result in a significantly lower rate of all-cause deaths or unplanned hospitalisations in HF patients.,"['all-cause deaths or unplanned hospitalisations in heart failure (HF) at 18\u2009months', '937 patients hospitalised for acute HF ≤12\u2009months before inclusion', 'in heart failure']","['telemonitoring (daily body-weight measurement, daily recording of HF symptoms, and personalised education) (n\xa0=\xa0482) or to SC', 'telemonitoring programme versus standard care (SC', 'Telemonitoring versus standard of care']","['Mean\u2009±\u2009standard deviation number of events', 'median time to all-cause death or first unplanned hospitalisation', 'rate of all-cause deaths or unplanned hospitalisations', 'relative risk reduction']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",937.0,0.224831,Telemonitoring did not result in a significantly lower rate of all-cause deaths or unplanned hospitalisations in HF patients.,"[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Galinier', 'Affiliation': 'Toulouse Rangueil University Hospital (CHU), Cardiology, Toulouse, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Berdague', 'Affiliation': 'Beziers Hospital Centre, Beziers, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Brierre', 'Affiliation': ""Intercommunal Hospital Centre des Vallées de l'Ariege, Foix, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cantie', 'Affiliation': 'Intercommunal Hospital Centre Castres-Mazamet, Castres, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dary', 'Affiliation': 'Private Practice, Saint Yrieix La Perche, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Ferradou', 'Affiliation': 'Cardiology Aftercare and Rehabilitation Centre, Beaumont De Lomagne, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fondard', 'Affiliation': 'Pasteur Clinic, Toulouse, France.'}, {'ForeName': 'Jean Philippe', 'Initials': 'JP', 'LastName': 'Labarre', 'Affiliation': 'Pont de Chaume Clinic, Montauban, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Mansourati', 'Affiliation': 'CHRU Brest, Brest, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Picard', 'Affiliation': ""Unité d'insuffisance cardiaque, Centre Hospitalier Universitaire de Bordeaux, France.""}, {'ForeName': 'Jean-Etienne', 'Initials': 'JE', 'LastName': 'Ricci', 'Affiliation': 'University Hospital of Nimes, Nimes, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Salvat', 'Affiliation': 'University Hospital of Grenoble, Grenoble, France.'}, {'ForeName': 'Lamia', 'Initials': 'L', 'LastName': 'Tartière', 'Affiliation': 'Leon Berard Hospital, Hyeres, France.'}, {'ForeName': 'Jean-Bernard', 'Initials': 'JB', 'LastName': 'Ruidavets', 'Affiliation': 'INSERM UMR - U1027, Toulouse, France.'}, {'ForeName': 'Vanina', 'Initials': 'V', 'LastName': 'Bongard', 'Affiliation': 'USMR - CHU Toulouse, Toulouse, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Delval', 'Affiliation': 'Air Liquide Santé International, Loges en Josas, France.'}, {'ForeName': 'Guila', 'Initials': 'G', 'LastName': 'Lancman', 'Affiliation': 'Air Liquide Santé International, Loges en Josas, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Pasche', 'Affiliation': 'Air Liquide Santé International, Loges en Josas, France.'}, {'ForeName': 'Juan Fernando', 'Initials': 'JF', 'LastName': 'Ramirez-Gil', 'Affiliation': 'Air Liquide Santé International, Loges en Josas, France.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Department of Cardiovascular Medicine, Princess Grace Hospital, Monaco.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1906']
3145,31176090,Air-abrasion using new silica-alumina powders containing different silica concentrations: Effect on the microstructural characteristics and fatigue behavior of a Y-TZP ceramic.,"This study assessed the fatigue performance (biaxial flexure fatigue strength), surface characteristics (topography and roughness) and structural stability (t-m phase transformation) of a Y-TZP ceramic subjected to air-abrasion using new powders (7% and 20% silica-coated aluminum oxide particles) in comparison to commercially available powders. Disc-shaped specimens were manufactured (ISO 6872-2015) and randomly allocated into four groups considering the air-abrasion materials: SiC: commercially available silica-coated aluminum oxide; AlOx: commercially available aluminum oxide; 7%Si and 20%Si: experimentally produced materials consisting of 7% and 20% silica-coated AlOx, respectively. Air-abrasion was executed by a blinded researcher (1 cm distance from the tip to the specimen surface, under 2.8 bar pressure for 10 s). The fatigue tests (n = 15) were performed by the staircase method under a piston-on-three-balls assembly. Topography and roughness assessments (n = 30) of abraded samples and fractography of failed discs were performed. The highest fatigue strength (MPa) was observed for 7%Si (887.20 ± 50.54) and SiC (878.16 ± 29.81), while the lowest fatigue strength for 20%Si (773.89 ± 46.44) and AlOx (796.70 ± 46.48). Topography analysis depicted similar surface morphology for all conditions. However, roughness (μm) was only statistically different between 7%Si (Ra = 0.30 ± 0.09; Rz = 2.31 ± 0.63) and SiC (Ra = 0.26 ± 0.04; Rz = 1.99 ± 0.34). Monoclinic phase grains appeared on Y-TZP surface in a similar content (≈11-12%) for the protocols. Fractography showed all failures starting on air-abraded surface/sub-surface defects from the tensile side. In terms of roughness, phase transformation and fatigue, the new 7% silica-coated aluminum oxide presented similar behavior to the commercially available powder. Increasing silica-coating concentration to 20% did not lead to a gentle air-abrasion protocol.",2019,"The highest fatigue strength (MPa) was observed for 7%Si (887.20 ± 50.54) and SiC (878.16 ± 29.81), while the lowest fatigue strength for 20%Si (773.89 ± 46.44) and AlOx (796.70 ± 46.48).",[],"['TZP ceramic subjected to air-abrasion using new powders (7% and 20% silica-coated aluminum oxide particles', 'air-abrasion materials: SiC: commercially available silica-coated aluminum oxide; AlOx: commercially available aluminum oxide; 7%Si and 20%Si']","['lowest fatigue strength', 'fatigue performance (biaxial flexure fatigue strength), surface characteristics (topography and roughness) and structural stability', 'highest fatigue strength (MPa']",[],"[{'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1302752', 'cui_str': 'Abrasion (morphologic abnormality)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0887544', 'cui_str': 'Aluminum Oxide (AlO2)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449588', 'cui_str': 'Surface characteristics (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",15.0,0.027496,"The highest fatigue strength (MPa) was observed for 7%Si (887.20 ± 50.54) and SiC (878.16 ± 29.81), while the lowest fatigue strength for 20%Si (773.89 ± 46.44) and AlOx (796.70 ± 46.48).","[{'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Cadore-Rodrigues', 'Affiliation': 'Post-Graduate Program in Oral Science, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Marechal Floriano Peixoto Street 1184, 97015-372, Brazil. Electronic address: anacadorerodrigues@gmail.com.'}, {'ForeName': 'Catina', 'Initials': 'C', 'LastName': 'Prochnow', 'Affiliation': 'Post-Graduate Program in Oral Science, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Marechal Floriano Peixoto Street 1184, 97015-372, Brazil. Electronic address: catinaprochnow@hotmail.com.'}, {'ForeName': 'Marília Pivetta', 'Initials': 'MP', 'LastName': 'Rippe', 'Affiliation': 'Post-Graduate Program in Oral Science, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Marechal Floriano Peixoto Street 1184, 97015-372, Brazil. Electronic address: mariliarippe@mail.ufsm.br.'}, {'ForeName': 'Jivago Schumacher de', 'Initials': 'JS', 'LastName': 'Oliveira', 'Affiliation': 'Post-Graduate Program in Chemical Engineering, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Roraima Avenue 1000, 97015-900, Brazil. Electronic address: jivago.s.o@hotmail.com.'}, {'ForeName': 'Sérgio Luiz', 'Initials': 'SL', 'LastName': 'Jahn', 'Affiliation': 'Post-Graduate Program in Chemical Engineering, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Roraima Avenue 1000, 97015-900, Brazil. Electronic address: sergiojahn@gmail.com.'}, {'ForeName': 'Edson Luiz', 'Initials': 'EL', 'LastName': 'Foletto', 'Affiliation': 'Post-Graduate Program in Chemical Engineering, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Roraima Avenue 1000, 97015-900, Brazil. Electronic address: efoletto@gmail.com.'}, {'ForeName': 'Gabriel Kalil Rocha', 'Initials': 'GKR', 'LastName': 'Pereira', 'Affiliation': 'MSc Post-Graduate Program in Dentistry, School of Dentistry, Meridional Faculty - IMED, Passo Fundo, Rio Grande do Sul State, Senador Pinheiro Street, 304, 99070-220, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Post-Graduate Program in Oral Science, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Marechal Floriano Peixoto Street 1184, 97015-372, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.05.032']
3146,31343947,Cellular and morphological changes with EAA supplementation before and after total knee arthroplasty.,"Investigate the underlying cellular basis of muscle atrophy (Placebo) and atrophy reduction (essential amino acid supplementation, EAAs) in total knee arthroplasty (TKA) patients by examining satellite cells and other key histological markers of inflammation, recovery, and fibrosis. Forty-one subjects (53-76 yr) scheduled for TKA were randomized into two groups, ingesting 20 g of EAAs or placebo, twice-daily, for 7 days before TKA and for 6 wk after surgery. A first set of muscle biopsies was obtained from both legs before surgery in the operating room, and patients were randomly assigned and equally allocated to have two additional biopsies at either 1 or 2 wk after surgery. Biopsies were processed for gene expression and immunohistochemistry. Satellite cells were significantly higher in patients ingesting 20 g of essential amino acids twice daily for the 7 days leading up to surgery compared with Placebo (operative leg  P  = 0.03 for satellite cells/fiber and  P  = 0.05 for satellite cell proportions for Type I-associated cells and  P  = 0.05 for satellite cells/fiber for Type II-associated cells.) Myogenic regulatory factor gene expression was different between groups, with the Placebo Group having elevated MyoD expression at 1 wk and EAAs having elevated myogenin expression at 1 wk. M1 macrophages were more prevalent in Placebo than the EAAs Group. IL-6 and TNF-α transcripts were elevated postsurgery in both groups; however, TNF-α declined by 2 wk in the EAAs Group. EAAs starting 7 days before surgery increased satellite cells on the day of surgery and promoted a more favorable inflammatory environment postsurgery. NEW & NOTEWORTHY  Clinical studies by our group indicate that the majority of muscle atrophy after total knee arthroplasty (TKA) in older adults occurs rapidly, within the first 2 wks. We have also shown that essential amino acid supplementation (EAAs) before and after TKA mitigates muscle atrophy; however, the mechanisms are unknown. These results suggest that satellite cell numbers are elevated with EAA ingestion before surgery, and after surgery, EAA ingestion positively influences markers of inflammation. Combined, these data may help inform further studies designed to address the accelerated sarcopenia that occurs in older adults after major surgery.",2019,"M1 macrophages were more prevalent in Placebo than the EAAs Group. IL-6 and TNF-α transcripts were elevated postsurgery in both groups; however, TNF-α declined by 2 wk in the EAAs Group.","['total knee arthroplasty (TKA) patients', 'total knee arthroplasty', 'Forty-one subjects (53-76 yr) scheduled for TKA', 'older adults after major surgery']","['muscle atrophy (Placebo) and atrophy reduction (essential amino acid supplementation, EAAs', 'ingesting 20 g of EAAs or placebo', 'Placebo', 'total knee arthroplasty (TKA']","['satellite cells', 'M1 macrophages', 'TNF-α', 'Satellite cells', 'Myogenic regulatory factor gene expression', 'IL-6 and TNF-α transcripts', 'elevated MyoD expression']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0026846', 'cui_str': 'Atrophy, Muscle'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation (product)'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0332221', 'cui_str': 'Satellite (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0206474', 'cui_str': 'Myogenic Regulatory Factors'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",41.0,0.162478,"M1 macrophages were more prevalent in Placebo than the EAAs Group. IL-6 and TNF-α transcripts were elevated postsurgery in both groups; however, TNF-α declined by 2 wk in the EAAs Group.","[{'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Muyskens', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Foote', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Nathan J', 'Initials': 'NJ', 'LastName': 'Bigot', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Strycker', 'Affiliation': 'Oregon Research Institute, Eugene, Oregon.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Smolkowski', 'Affiliation': 'Oregon Research Institute, Eugene, Oregon.'}, {'ForeName': 'Tessa K', 'Initials': 'TK', 'LastName': 'Kirkpatrick', 'Affiliation': 'Slocum Research and Education Foundation, Eugene, Oregon.'}, {'ForeName': 'Brick A', 'Initials': 'BA', 'LastName': 'Lantz', 'Affiliation': 'Slocum Center for Orthopedics and Sports Medicine, Eugene, Oregon.'}, {'ForeName': 'Steven N', 'Initials': 'SN', 'LastName': 'Shah', 'Affiliation': 'Slocum Center for Orthopedics and Sports Medicine, Eugene, Oregon.'}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Mohler', 'Affiliation': 'Slocum Center for Orthopedics and Sports Medicine, Eugene, Oregon.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Jewett', 'Affiliation': 'Slocum Center for Orthopedics and Sports Medicine, Eugene, Oregon.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Owen', 'Affiliation': 'Slocum Research and Education Foundation, Eugene, Oregon.'}, {'ForeName': 'Hans C', 'Initials': 'HC', 'LastName': 'Dreyer', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00869.2018']
3147,31424431,E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy.,"Improving patient education focusing on bowel preparation before a colonoscopy leads to cleaner colons. Endoscopy units must obtain informed consent and perform a risk assessment for sedative use prior to a colonoscopy. The current practice in the Netherlands to achieve these goals is nurse counseling in an outpatient setting. This is costly and has disadvantages in terms of uniformity and time consumption for both the patient and the hospital. The hypothesis is that computer-based education with use of video and 3D animations may replace nurse counseling in most cases, without losing quality of bowel cleanliness during colonoscopy. This multicenter, randomized, endoscopist blinded clinical trial evaluates a primary outcome measure (bowel preparation) during colonoscopy. Secondary outcome measures are sickness absence, patient anxiety after instruction and prior to colonoscopy, patient satisfaction and information re-call. The study will be performed in four endoscopy units of different levels (rural, urban, and tertiary). Inclusion criteria are adult age and referral for complete colonoscopy. Exclusion criteria are Dutch illiteracy, audiovisual handicaps or mental disabilities and no (peers with) internet access. This trial aims to establish online computer-based education as tool for patient education prior to a colonoscopy. By choosing a direct comparison with the standard of care (nurse counseling), both endoscopic quality measures and patient related outcome measures can be evaluated.",2019,"Secondary outcome measures are sickness absence, patient anxiety after instruction and prior to colonoscopy, patient satisfaction and information re-call.","['four endoscopy units of different levels (rural, urban, and tertiary', 'Exclusion criteria are Dutch illiteracy, audiovisual handicaps or mental disabilities and no (peers with) internet access', 'patient education prior to a colonoscopy']","['E-Patient Counseling Trial (E-PACO', 'Computer Based Education versus Nurse Counseling']","['sickness absence, patient anxiety after instruction and prior to colonoscopy, patient satisfaction and information re-call']","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0020899', 'cui_str': 'Illiteracy'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C1306341', 'cui_str': 'Mental handicap (finding)'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",,0.0720973,"Secondary outcome measures are sickness absence, patient anxiety after instruction and prior to colonoscopy, patient satisfaction and information re-call.","[{'ForeName': 'Govert', 'Initials': 'G', 'LastName': 'Veldhuijzen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center; Govert.Veldhuijzen@radboudumc.nl.'}, {'ForeName': 'Aura A', 'Initials': 'AA', 'LastName': 'van Esch', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Klemt-Kropp', 'Affiliation': 'Department of Gastroenterology and Hepatology, North West Clinics.'}, {'ForeName': 'Jochim S', 'Initials': 'JS', 'LastName': 'Terhaar Sive Droste', 'Affiliation': 'Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital.'}, {'ForeName': 'Joost P H', 'Initials': 'JPH', 'LastName': 'Drenth', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center.'}]",Journal of visualized experiments : JoVE,['10.3791/58798']
3148,32438192,MicroRNA expression in response to bisphenol A is associated with high blood pressure.,"Bisphenol A (BPA) is a ubiquitous environmental contaminant that is known to be associated with the risk of arterial hypertension. However, the underlying mechanisms describing how BPA exposure leads to high blood pressure (BP) and the role of epigenetics are still unclear. Therefore, we evaluated associations among BPA exposure, microRNA (miRNA) expression, and BP in a randomized crossover trial with 45 non-smoking females over 60 years of age. The participants visited the study site 3 times and were dose-dependently exposed to BPA. Two hours after exposure to BPA, urine and whole blood were collected for BPA measurement and miRNA profiling, and BP was measured. Relationships among urinary BPA level, miRNA expression, and BP were estimated using the mixed effect model. Decreases in miR-30a-5p, miR-580-3p, miR-627-5p, and miR-671-3p and increases in miR-636 and miR-1224-3p attributable to BPA exposure were associated with high BP. The core functional network from BPA exposure to increased BP was found to be on the pathway through these six miRNAs and their predicted BP-related target genes. Our results suggest that epigenetic biomarkers for BPA exposure and hypertension provide mechanistic data to explain hypertension exacerbation as well as key information for predicting the health effects of BPA exposure.",2020,"Decreases in miR-30a-5p, miR-580-3p, miR-627-5p, and miR-671-3p and increases in miR-636 and miR-1224-3p attributable to BPA exposure were associated with high BP.",['45 non-smoking females over 60\xa0years of age'],['Bisphenol A (BPA'],"['urinary BPA level, miRNA expression, and BP', 'blood pressure (BP', 'BPA exposure, microRNA (miRNA) expression, and BP', 'BPA measurement and miRNA profiling, and BP']","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0053800', 'cui_str': 'bisphenol A'}]","[{'cui': 'C0053800', 'cui_str': 'bisphenol A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",45.0,0.0257088,"Decreases in miR-30a-5p, miR-580-3p, miR-627-5p, and miR-671-3p and increases in miR-636 and miR-1224-3p attributable to BPA exposure were associated with high BP.","[{'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Integrative Bioscience & Biotechnology, Sejong University, Seoul 05006, Republic of Korea. Electronic address: jhkim777@sejong.ac.kr.'}, {'ForeName': 'Yoon Hee', 'Initials': 'YH', 'LastName': 'Cho', 'Affiliation': 'Department of Biomedical and Pharmaceutical Sciences, The University of Montana, Montana 59812-1552, USA. Electronic address: unicho3@gmail.com.'}, {'ForeName': 'Yun-Chul', 'Initials': 'YC', 'LastName': 'Hong', 'Affiliation': 'Department of Preventive Medicine, Seoul National University College of Medicine, Seoul 110-799, Republic of Korea.'}]",Environment international,['10.1016/j.envint.2020.105791']
3149,32438716,Photobiomodulation Therapy on Orthodontic Movement: Analysis of Preliminary Studies with a New Protocol.,"This study aimed to investigate the effectiveness of photobiomodulation therapy (PBMT) on the acceleration of orthodontic movements, deriving from its biostimulating and regenerative capacity on soft tissues, consequent to the increase in differentiation, proliferation, and activity of cells that are involved with alveolar bone remodeling. The present randomized controlled trial was conducted on six patients who required extractive orthodontic therapy because their ectopic canines had erupted. A total of eight canines were analyzed, four of which received laser irradiation (i.e., experimental group). Two weeks after the extractions, all canines of the experimental and placebo groups were distalized simultaneously and symmetrically with the laceback retraction technique. The PBMT protocol consisted of four cycles of laser applications, one each on days 0, 3, 7, and 14 of the study, with session treatment durations of 2-4 min. The results of the descriptive analysis on the distal displacement speed of the canines after 1 month of follow-up indicate an average displacement of 1.35 mm for the non-irradiated group and 1.98 mm for the irradiated group. Through inferential analysis, a statistically significant difference ( p  < 0.05) was found between the average speed of the irradiated canines and the control canines. The low energy density laser used in this study, with the parameters set, was found to be a tool capable of statistically significantly accelerating the distal displacement of canines.",2020,"Through inferential analysis, a statistically significant difference ( p  < 0.05) was found between the average speed of the irradiated canines and the control canines.",['six patients who required extractive orthodontic therapy because their ectopic canines had erupted'],"['Photobiomodulation Therapy', 'photobiomodulation therapy (PBMT', 'laser irradiation', 'placebo']","['distal displacement of canines', 'distal displacement speed']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",8.0,0.0304746,"Through inferential analysis, a statistically significant difference ( p  < 0.05) was found between the average speed of the irradiated canines and the control canines.","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Impellizzeri', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Horodynski', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Fusco', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Gaspare', 'Initials': 'G', 'LastName': 'Palaia', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Polimeni', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Romeo', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Ersilia', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Galluccio', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17103547']
3150,32438719,"Effect of a Combination of Citrus Flavones and Flavanones and Olive Polyphenols for the Reduction of Cardiovascular Disease Risk: An Exploratory Randomized, Double-Blind, Placebo-Controlled Study in Healthy Subjects.","A single-center, randomized, double-blind controlled trial was conducted to assess the efficacy of a food supplement based on a combination of grapefruit, bitter orange, and olive extracts administered for eight weeks (n = 51) versus placebo (n = 45) on reduction of cardiovascular risk in healthy volunteers. Study variables included flow-mediated vasodilation (FMD), blood pressure (BP), lipid profile, thrombotic status, oxidative stress biomarkers, inflammation-related biomarkers, anthropometric variables, quality of life, and physical activity. The per-protocol data set was analyzed. In the active product group, there were statistically significant within-group differences at eight weeks as compared with baseline in FMD, systolic and diastolic BP, total cholesterol, LDL-C, LDL-oxidase, oxidized/reduced glutathione ratio, protein carbonyl, and IL-6. Significant between-group differences in these variables were also found. Significant changes in anthropometric variables and quality of life were not observed in the study groups. Changes in the level of physical activity were not recorded. Treatment with the active product was well tolerated. All these findings, taken together, support a beneficial effect of supplementation with a mixture of grapefruit, bitter orange fruits, and olive leaf extracts on underlying mechanisms that may interact each other to decrease the cardiovascular risk in healthy people.",2020,"In the active product group, there were statistically significant within-group differences at eight weeks as compared with baseline in FMD, systolic and diastolic BP, total cholesterol, LDL-C, LDL-oxidase, oxidized/reduced glutathione ratio, protein carbonyl, and","['healthy volunteers', 'healthy people', 'Healthy Subjects']","['placebo', 'Placebo', 'Citrus Flavones and Flavanones and Olive Polyphenols', 'grapefruit, bitter orange, and olive extracts']","['flow-mediated vasodilation (FMD), blood pressure (BP), lipid profile, thrombotic status, oxidative stress biomarkers, inflammation-related biomarkers, anthropometric variables, quality of life, and physical activity', 'cardiovascular risk', 'FMD, systolic and diastolic BP, total cholesterol, LDL-C, LDL-oxidase, oxidized/reduced glutathione ratio, protein carbonyl, and', 'tolerated', 'Cardiovascular Disease Risk', 'level of physical activity', 'anthropometric variables and quality of life']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008865', 'cui_str': 'Citrus'}, {'cui': 'C0016219', 'cui_str': '2-Phenyl-2-Ene-Benzopyran-4-One Compounds'}, {'cui': 'C0060425', 'cui_str': 'flavanone'}, {'cui': 'C0228539', 'cui_str': 'Olivary nucleus structure'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0440280', 'cui_str': 'GRAPEFRUIT EXTRACT'}, {'cui': 'C0330922', 'cui_str': 'Citrus aurantium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0242417', 'cui_str': 'Oxidase'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.237868,"In the active product group, there were statistically significant within-group differences at eight weeks as compared with baseline in FMD, systolic and diastolic BP, total cholesterol, LDL-C, LDL-oxidase, oxidized/reduced glutathione ratio, protein carbonyl, and","[{'ForeName': 'Maravillas', 'Initials': 'M', 'LastName': 'Sánchez Macarro', 'Affiliation': 'Health Sciences Department, Universidad Católica San Antonio de Murcia (UCAM), Campus de los Jerónimos, E-30107 Murcia, Spain.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Martínez Rodríguez', 'Affiliation': 'Health Sciences Ph.D. Program, Universidad Católica San Antonio de Murcia (UCAM), Campus de los Jerónimos, E-30107 Murcia, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Bernal Morell', 'Affiliation': 'Unidad de Enfermedades Infecciosas, Hospital General Universitario Reina Sofia, E-30003 Murcia, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pérez-Piñero', 'Affiliation': 'Health Sciences Department, Universidad Católica San Antonio de Murcia (UCAM), Campus de los Jerónimos, E-30107 Murcia, Spain.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Victoria-Montesinos', 'Affiliation': 'Health Sciences Department, Universidad Católica San Antonio de Murcia (UCAM), Campus de los Jerónimos, E-30107 Murcia, Spain.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'García-Muñoz', 'Affiliation': 'Health Sciences Department, Universidad Católica San Antonio de Murcia (UCAM), Campus de los Jerónimos, E-30107 Murcia, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Cánovas García', 'Affiliation': 'Health Sciences Department, Universidad Católica San Antonio de Murcia (UCAM), Campus de los Jerónimos, E-30107 Murcia, Spain.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Castillo Sánchez', 'Affiliation': 'Research and Development Department, Nutrafur iff-Health, E-30820 Murcia, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'López-Román', 'Affiliation': 'Health Sciences Department, Universidad Católica San Antonio de Murcia (UCAM), Campus de los Jerónimos, E-30107 Murcia, Spain.'}]",Nutrients,['10.3390/nu12051475']
3151,31417304,Effects of anesthetic technique and surgery on myeloid-derived suppressor cells and prognosis in women who underwent breast cancer surgery: a prospective study.,"Background:  Surgery and anesthesia-induced immunosuppression may play a critical role in tumor progression and metastasis. Myeloid-derived suppressor cells (MDSCs) are highly immunosuppressive myeloid cells, closely linked with tumor staging, clinical therapeutic efficacy and prognosis. This study aims to investigate the effect of anesthetic technique and surgery on the expression of MDSCs and prognosis in women who received breast cancer surgery.  Methods:  From March 2016 to January 2017, a total of 80 patients with breast cancer were prospectively enrolled and randomized into two anesthetic groups: sevoflurane-based anesthetic group (SEV; n=38) and propofol-based total intravenous anesthetic group (TIVA; n=42). The expression of MDSCs and prognosis between different anesthetic techniques and stresses of surgical methods were compared. The primary endpoint is the postoperative expression of MDSCs and prognosis between SEV and TIVA groups. The secondary endpoint is the VAS scores at 24 hr post-operation between SEV and TIVA groups.  Results:  There was no significant difference in postoperative expression of MDSCs ( P =0.202) and prognosis ( P =0.138) between SEV and TIVA groups. Compared to breast-conserving surgery (BCS), patients who underwent breast mastectomy had significantly fewer MDSCs ( P =0.040) and lower VAS score at 24 hr post-operation ( P =0.044), while no significant difference in prognosis was found ( P =0.953). When MDSCs were classified as subtypes of granulocytic/polymorphonuclear (PMN)-MDSCs and monocytic (Mo)-MDSCs, it showed higher ratio of Mo-MDSCs ( P =0.018) or lower ratio of (PMN)-MDSCs ( P =0.022) correlates to later tumor stage.  Conclusion:  Sevoflurane and propofol-based anesthesia do not show significant difference in MDSCs expression and prognosis after breast cancer surgery. Compared to BCS, although mastectomy with high extent of surgical stress exhibits lower levels of MDSCs, there is no significant difference in prognosis. The ratio of MDSCs subtype correlates to tumor stage.",2019,There was no significant difference in postoperative expression of MDSCs ( P =0.202) and prognosis ( P =0.138) between SEV and TIVA groups.,"['women who underwent breast cancer surgery', 'women who received breast cancer surgery', 'Methods:  From March 2016 to January 2017, a total of 80 patients with breast cancer']","['Sevoflurane and propofol-based anesthesia', 'sevoflurane-based anesthetic group (SEV; n=38) and propofol-based total intravenous anesthetic', 'breast-conserving surgery (BCS', 'anesthetic technique and surgery']","['postoperative expression of MDSCs and prognosis', 'postoperative expression of MDSCs', 'VAS scores', 'VAS score', 'MDSCs', 'MDSCs expression and prognosis']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0458216', 'cui_str': 'Sev (substance)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242904', 'cui_str': 'Anesthetics, Intravenous'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",80.0,0.029103,There was no significant difference in postoperative expression of MDSCs ( P =0.202) and prognosis ( P =0.138) between SEV and TIVA groups.,"[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yan', 'Affiliation': ""Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, People's Republic of China.""}, {'ForeName': 'Guo-Hua', 'Initials': 'GH', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, People's Republic of China.""}, {'ForeName': 'Yao-Zhong', 'Initials': 'YZ', 'LastName': 'Cheng', 'Affiliation': ""Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, People's Republic of China.""}, {'ForeName': 'Lin-Xin', 'Initials': 'LX', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, People's Republic of China.""}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, People's Republic of China.""}, {'ForeName': 'Yu-Lin', 'Initials': 'YL', 'LastName': 'Sun', 'Affiliation': ""State Key Laboratory of Molecular Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': ""Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen 518116, People's Republic of China.""}]",Cancer management and research,['10.2147/CMAR.S183519']
3152,32438138,External pop-out versus classic technique for delivery of the fetal head during elective cesarean section: A randomized clinical trial.,"OBJECTIVE


This study aims to compare two techniques (External pop-out versus classic technique) for delivery of the fetal head during elective cesarean section (CS).The potential clinical predictors associated with unintended uterine incision extension during fetal head delivery among women delivered by elective CS were also assessed.
METHODS


A randomized clinical trial conducted at a tertiary University hospital between February 2017 and January 2019. Participants were randomly assigned to the classic head delivery technique (group I) or external Pop-out (EPO) technique (group II). The primary outcome was the incidence of unintended uterine incision extension during elective CS. A logistic regression model was utilized to examine the association between patient's characteristics and the occurrence of unintended uterine incision extension.
RESULTS


Participants in both groups (455 women in each group) had similar demographic characteristics. The EPO group had a significantly lower incidence of uterine incision extension than the classic group (p = 0.006). The operative time was significantly shorter in the EPO group (p = 0.000), which was also significantly easier than the classic technique (p = 0.001). The high body mass index (p = 0.004), previous delivery by CS (p = 0.010), high birth weight (p = 0.001) and the classic technique for head delivery (p = 0.002) were significant predictors for uterine incision tears.
CONCLUSIONS


EPO technique is an easy technique for fetal head delivery during elective CS with a lower risk of uterine incision extension and shorter operative time.",2020,The EPO group had a significantlylower incidence of uterine incision extension than the classic group(p = 0.006).,"['fetal head during elective cesarean section', 'Participants in both groups (455 women in each group) had similar demographic characteristics', 'tertiary University hospital betweenFebruary 2017 andJanuary 2019']","['External pop-out versus classic technique', 'EPO', 'techniques (External pop-out versus classic technique', 'classic head delivery technique (group I) or external Pop-out (EPO) technique']","['incidence of unintendeduterine incision extension during elective CS', 'high birth weight', 'operative time', 'high body mass index', 'uterine incision extension', 'classic technique for head delivery']","[{'cui': 'C0231117', 'cui_str': 'Fetal head structure'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0441843', 'cui_str': 'Group I'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0349482', 'cui_str': 'High birth weight'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",,0.0981983,The EPO group had a significantlylower incidence of uterine incision extension than the classic group(p = 0.006).,"[{'ForeName': 'Ali M El', 'Initials': 'AME', 'LastName': 'Saman', 'Affiliation': ""Department of Obstetrics & Gynecology, Woman's Health Hospital, Faculty of Medicine, Assiut University, Egypt.""}, {'ForeName': 'Mohamed Ashraf', 'Initials': 'MA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Obstetrics & Gynecology, Luxor International Hospital, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abbas', 'Affiliation': ""Department of Obstetrics & Gynecology, Woman's Health Hospital, Faculty of Medicine, Assiut University, Egypt. Electronic address: ahmedabbas@aun.edu.eg.""}, {'ForeName': 'Alshymaa H', 'Initials': 'AH', 'LastName': 'Eleraky', 'Affiliation': ""Department of Obstetrics & Gynecology, Woman's Health Hospital, Faculty of Medicine, Assiut University, Egypt.""}, {'ForeName': 'Mohammed K', 'Initials': 'MK', 'LastName': 'Ali', 'Affiliation': ""Department of Obstetrics & Gynecology, Woman's Health Hospital, Faculty of Medicine, Assiut University, Egypt.""}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101806']
3153,32438639,"Safety, Tolerability and Efficacy of Dietary Supplementation with Concord Grape Juice in Gulf War Veterans with Gulf War Illness: A Phase I/IIA, Randomized, Double-Blind, Placebo-Controlled Trial.","Approximately 30 percent of U.S. veterans deployed during the Gulf War (1990-1991) have been diagnosed with Gulf War Illness (GWI), a chronic multi-symptom disorder without widely available specific treatments. We investigated whether the consumption of Concord grape juice (CGJ), rich in anti-inflammatory flavonoids, would be tolerated and safe in individuals with GWI and explored improvement in cognitive function and fatigue. Thirty-six veterans with GWI enrolled in a 24-week randomized, double-blind, Phase I/IIA clinical trial to explore safety, tolerability, and feasibility of 16 ounces daily of commercially available CGJ compared to placebo. Participants completed neurocognitive tests and self-reported surveys at baseline, 12 and 24 weeks. Thirty-one participants (86%) completed the study; no dropouts were related to side effects. Thirty participants (83%) documented ≥80% adherence. There were no statistically significant unadjusted differences between CGJ and placebo groups in change in efficacy measures from baseline to endpoint. We employed general linear regression models controlling for baseline differences between groups which indicated statistically significant improvement in the Halstead Category Test-Russell Revised Version (RCAT) at endpoint in the CGJ group compared to placebo (8.4 points,  p  = 0.04). Other measures of cognitive functioning did not indicate significant improvements in the adjusted analyses ( p -values: 0.09-0.32), nor did the fatigue variable ( p  = 0.67). CGJ was safe and well-tolerated by veterans with GWI. Our data suggest high tolerability and potential benefit from CGJ in veterans with GWI and can be used to inform future studies of efficacy.",2020,"Other measures of cognitive functioning did not indicate significant improvements in the adjusted analyses ( p -values: 0.09-0.32), nor did the fatigue variable ( p  = 0.67).","['Approximately 30 percent of U.S. veterans deployed during the Gulf War (1990-1991) have been diagnosed with Gulf War Illness (GWI), a chronic multi-symptom disorder without widely available specific treatments', 'Thirty-six veterans with GWI enrolled', 'Gulf War Veterans with Gulf War Illness', 'veterans with GWI']","['CGJ', 'Placebo', 'Dietary Supplementation with Concord Grape Juice', 'consumption of Concord grape juice (CGJ', 'placebo']","['Safety, Tolerability and Efficacy', 'cognitive functioning', 'safe and well-tolerated', 'tolerated and safe', 'Halstead Category Test-Russell Revised Version (RCAT']","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1449761', 'cui_str': 'Persian Gulf War, 1991'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319606', 'cui_str': '36'}]","[{'cui': 'C4224777', 'cui_str': 'Concord grape juice'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C4505444', 'cui_str': 'Halstead Category Test'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",,0.431748,"Other measures of cognitive functioning did not indicate significant improvements in the adjusted analyses ( p -values: 0.09-0.32), nor did the fatigue variable ( p  = 0.67).","[{'ForeName': 'Drew A', 'Initials': 'DA', 'LastName': 'Helmer', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Van Doren', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Litke', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'Chin-Lin', 'Initials': 'CL', 'LastName': 'Tseng', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'Lap', 'Initials': 'L', 'LastName': 'Ho', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY 10029, USA.'}, {'ForeName': 'Omowunmi', 'Initials': 'O', 'LastName': 'Osinubi', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'Giulio Maria', 'Initials': 'GM', 'LastName': 'Pasinetti', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY 10029, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17103546']
3154,25819697,Provision of lipid-based nutrient supplements to Honduran children increases their dietary macro- and micronutrient intake without displacing other foods.,"Inadequate energy intake and poor diet quality are important causes of chronic child undernutrition. Strategies for improving diet quality using lipid-based nutrient supplements (LNS) are currently being tested in several countries. To date, information on children's dietary intakes during LNS use is available only from Africa. In this study, we collected 24-h dietary recalls at baseline, 3, 6, 9 and 12 months on Honduran children (n = 298) participating in a cluster-randomised trial of LNS. Generalised estimating equations were used to examine differences in number of servings of 12 food groups in the LNS and control arms, and multi-level mixed effects models were used to compare macro- and micronutrient intakes. Models accounted for clustering and adjusted for child's age, season and breastfeeding status. Mean daily servings of 12 food groups did not differ by study arm at baseline and remained similar throughout the study with the exception of groups that were partially or entirely supplied by LNS (nuts and nut butters, fats, and sweets). Baseline intakes of energy, fat, carbohydrates, protein, folate and vitamin A, but not vitamin B12, iron and zinc were lower in the LNS than control arm. The change in all macro- and micronutrients from baseline to each study visit was larger for the LNS arm than the control, except for carbohydrates from baseline to 9 months. These findings indicate that LNS improved the macro- and micronutrient intakes of young non-malnourished Honduran children without replacing other foods in their diet.",2015,"The change in all macro- and micronutrients from baseline to each study visit was larger for the LNS arm than the control, except for carbohydrates from baseline to 9 months.",['Honduran children (n\u2009=\u2009298) participating in a cluster-randomised trial of'],"['LNS', 'lipid-based nutrient supplements', 'lipid-based nutrient supplements (LNS']","['Mean daily servings', 'Baseline intakes of energy, fat, carbohydrates, protein, folate and vitamin A, but not vitamin B12, iron and zinc', 'macro- and micronutrient intakes']","[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}]",,0.0391692,"The change in all macro- and micronutrients from baseline to each study visit was larger for the LNS arm than the control, except for carbohydrates from baseline to 9 months.","[{'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Flax', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Siega-Riz', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Greg A', 'Initials': 'GA', 'LastName': 'Reinhart', 'Affiliation': 'The Mathile Institute for the Advancement of Human Nutrition®, Dayton, Ohio, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Bentley', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12182']
3155,32438659,The Effects of Two Intervention Strategies to Reduce the Intake of Salt and the Sodium-To-Potassium Ratio on Cardiovascular Risk Factors. A 4-Month Randomised Controlled Study among Healthy Families.,"The aim was to examine the effects of two different salt reduction strategies on selected cardiovascular risk factors. The study was a four-month cluster randomised controlled study. Eighty-nine healthy Danish families (309 individuals) were randomly assigned to either (A) gradually salt-reduced bread, (B) gradually salt-reduced bread and dietary counselling to further reduce salt intake and increase potassium intake or (C) standard bread (control). The effect was assessed using linear mixed models. Intention to treat analyses comparing changes in the three groups showed a significant reduction in body fat percent (-1.31% (-2.40; -0.23)) and a borderline significant reduction in total plasma cholesterol (-0.25 mmol/L (-0.51; 0.01) and plasma renin (-0.19 pmol/L (-0.39; 0.00) in group A compared to the control group. Adjusted complete case analyses showed a significant reduction in total plasma cholesterol (-0.29 mmol/L (-0.50; -0.08), plasma LDL cholesterol (-0.08 mmol/L (-0.15; -0.00)), plasma renin (-0.23 pmol/L (-0.41; -0.05)), plasma adrenaline (-0.03 nmol/L (-0.06; -0.01)) and body fat percent (-1.53% (-2.51; -0.54)) in group A compared to the control group. No significant changes were found in group B compared to the control group. In conclusion, receiving sodium reduce bread was associated with beneficial changes in cardiovascular risk factors. No adverse effects were observed.",2020,Intention to treat analyses comparing changes in the three groups showed a significant reduction in body fat percent (-1.31% (-2.40; -0.23)) and a borderline significant reduction in total plasma cholesterol (-0.25 mmol/L (-0.51; 0.01) and plasma renin (-0.19 pmol/L (-0.39; 0.00) in group A compared to the control group.,"['Healthy Families', 'Eighty-nine healthy Danish families (309 individuals']","['salt reduction strategies', 'Sodium-To-Potassium Ratio', 'salt-reduced bread, (B) gradually salt-reduced bread and dietary counselling to further reduce salt intake and increase potassium intake or (C) standard bread (control']","['total plasma cholesterol', 'plasma renin', 'plasma adrenaline', 'plasma LDL cholesterol', 'cardiovascular risk factors', 'adverse effects', 'body fat percent']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0856882', 'cui_str': 'Potassium increased'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1278149', 'cui_str': 'Plasma LDL cholesterol measurement'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",89.0,0.0286472,Intention to treat analyses comparing changes in the three groups showed a significant reduction in body fat percent (-1.31% (-2.40; -0.23)) and a borderline significant reduction in total plasma cholesterol (-0.25 mmol/L (-0.51; 0.01) and plasma renin (-0.19 pmol/L (-0.39; 0.00) in group A compared to the control group.,"[{'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Toft', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, 2000 Frederiksberg, Denmark.'}, {'ForeName': 'Nanna Louise', 'Initials': 'NL', 'LastName': 'Riis', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, 2000 Frederiksberg, Denmark.'}, {'ForeName': 'Anne Dahl', 'Initials': 'AD', 'LastName': 'Lassen', 'Affiliation': 'National Food Institute, Technical University of Denmark, 2800 Kgs. Lyngby, Denmark.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Trolle', 'Affiliation': 'National Food Institute, Technical University of Denmark, 2800 Kgs. Lyngby, Denmark.'}, {'ForeName': 'Anne Helms', 'Initials': 'AH', 'LastName': 'Andreasen', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, 2000 Frederiksberg, Denmark.'}, {'ForeName': 'Amalie Kruse Sigersted', 'Initials': 'AKS', 'LastName': 'Frederiksen', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, 2000 Frederiksberg, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Joergensen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jens Kristian', 'Initials': 'JK', 'LastName': 'Munk', 'Affiliation': 'Department of Clinical Biochemistry, Amager and Hvidovre Hospital, 2650 Hvidovre, Denmark.'}, {'ForeName': 'Kirsten Schroll', 'Initials': 'KS', 'LastName': 'Bjoernsbo', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, 2000 Frederiksberg, Denmark.'}]",Nutrients,['10.3390/nu12051467']
3156,30191722,Adjunctive Internet-delivered cognitive behavioural therapy for insomnia in men with depression: A randomised controlled trial.,"OBJECTIVE


Internet-delivered cognitive behavioural therapy for insomnia is efficacious for insomnia, and post hoc analyses suggest mood improvements. We undertook the first clinical trial evaluating the efficacy of Internet-delivered cognitive behavioural therapy for insomnia on depressive symptoms as an adjunct to guideline-based treatment of depressive disorders.
METHODS


Older men undergoing psychiatrist-coordinated treatment for major depressive disorder or dysthymia and who had significant insomnia symptoms were randomised to either adjunctive Internet-delivered cognitive behavioural therapy for insomnia (Sleep Healthy Using The Internet) or online sleep psychoeducation. The primary outcome was change in depressive symptoms (Centre for Epidemiological Studies Depression scale) from baseline to week 12 (post intervention). Secondary outcomes were insomnia and anxiety symptoms.
RESULTS


In all, 87 men were randomised (Internet-delivered cognitive behavioural therapy for insomnia = 45; psychoeducation = 42). The mean observed Centre for Epidemiological Studies Depression scale changes by week 12 were 8.2 (standard deviation = 11.5) and 3.9 (standard deviation = 12.8) for Internet-delivered cognitive behavioural therapy for insomnia and psychoeducation, respectively. The adjunctive effect size of 0.35 in favour of Sleep Healthy Using The Internet programme was not statistically significant (group × time difference in the Mixed effect Model Repeat Measurement analysis difference 4.3; 95% confidence interval = [-1.2, 9.8]; p = 0.15). There was a statistically significant effect on insomnia symptoms (group × time p = 0.02, difference 2.7; 95% confidence interval = [0.2, 5.3]; effect size = 0.62). There were no differences in insomnia or depression at 6 months or differential effects on anxiety at any time point. There were no reported adverse trial-related events in the intervention arm.
CONCLUSION


Adjunctive Internet-delivered cognitive behavioural therapy for insomnia for older men being treated for depression can improve insomnia in the short term, without apparent harm. The short-term depressive symptom effect size in this pilot trial was comparable to other adjunctive interventions and may warrant a larger, definitive trial.",2019,"Adjunctive Internet-delivered cognitive behavioural therapy for insomnia for older men being treated for depression can improve insomnia in the short term, without apparent harm.","['87 men', 'men with depression', 'Older men undergoing psychiatrist-coordinated treatment for major depressive disorder or dysthymia and who had significant insomnia symptoms']","['cognitive behavioural therapy', 'Internet-delivered cognitive behavioural therapy', 'adjunctive Internet-delivered cognitive behavioural therapy for insomnia (Sleep Healthy Using The Internet) or online sleep psychoeducation', 'Adjunctive Internet-delivered cognitive behavioural therapy']","['insomnia and anxiety symptoms', 'insomnia or depression', 'depressive symptoms', 'mean observed Centre for Epidemiological Studies Depression scale changes', 'depressive symptoms (Centre for Epidemiological Studies Depression scale', 'insomnia symptoms', 'anxiety']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0013415', 'cui_str': 'Dysthymic Disorder'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}]","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002783', 'cui_str': 'Epidemiological Studies'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",87.0,0.233905,"Adjunctive Internet-delivered cognitive behavioural therapy for insomnia for older men being treated for depression can improve insomnia in the short term, without apparent harm.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Glozier', 'Affiliation': '1 Brain and Mind Centre, Sydney Medical School and Central Clinical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': '2 Black Dog Institute, The University of New South Wales, Randwick, NSW, Australia.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Griffiths', 'Affiliation': '3 Research School of Psychology, The Australian National University, Canberra, ACT, Australia.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Hickie', 'Affiliation': '1 Brain and Mind Centre, Sydney Medical School and Central Clinical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Naismith', 'Affiliation': '1 Brain and Mind Centre, Sydney Medical School and Central Clinical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Biddle', 'Affiliation': '1 Brain and Mind Centre, Sydney Medical School and Central Clinical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Overland', 'Affiliation': '1 Brain and Mind Centre, Sydney Medical School and Central Clinical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Thorndike', 'Affiliation': '7 BeHealth Solutions, Charlottesville, VA, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ritterband', 'Affiliation': '8 Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, Charlottesville, VA, USA.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867418797432']
3157,31804580,Randomized Trial of Mindfulness-Based Stress Reduction in Cardiac Patients Eligible for Cardiac Rehabilitation.,"Currently, exercise-based cardiac rehabilitation (CR) is the only recommended secondary prevention strategy for cardiac patients that attempts to tackle stress and psychosocial wellbeing, but it is under-utilized and lacks a comprehensive curriculum for this purpose; hence there is a critical gap to address psychosocial needs of cardiac patients after an event. Mindfulness-based stress reduction (MBSR) has shown benefits in the general population but its role in cardiac patients is not clear. We conducted a pilot randomized controlled trial (RCT) of MBSR in CR-eligible cardiac patients during their initial year of recovery. Patients were allocated 2:1 (intervention:control) to an 8-week MBSR group intervention or usual care. Standard measures of depression, anxiety, perceived stress, health related quality of life (HRQOL), blood pressure, biomarkers (lipids, HbA1c, CRP) and 24-hour Holter monitoring were obtained at baseline, 3- and 9-months post-randomization. Sub-group analyses were performed for participants with at least mild depression (PHQ-9 ≥ 5). 47 patients [mean age 58.6 years; 38% female; 77% white] were enrolled in 2 cohorts. 87% of MBSR patients completed the intervention; study retention was >95% at each follow-up visit. At 3 months, compared to controls, MBSR patients showed improvements in depression [p = 0.01] and anxiety [p = 0.04] with a similar trend in HRQOL [p = 0.06]. The MBSR group showed greater improvement or less worsening of most CV risk factors, with an attenuation of treatment effects at 9 months. Participants with at PHQ-9 scores ≥5 at baseline showed greater improvement in psychosocial and CV outcomes, that persisted at 9 months. MBSR is a safe and well received secondary prevention strategy. This pilot RCT provides preliminary evidence of MBSR's potential to improve short term psychosocial well-being in cardiac patients during their first year of recovery.",2019,This pilot RCT provides preliminary evidence of MBSR's potential to improve short term psychosocial well-being in cardiac patients during their first year of recovery.,"['Cardiac Patients Eligible for Cardiac Rehabilitation', 'participants with at least mild depression (PHQ-9\u2009≥\u20095', 'CR-eligible cardiac patients during their initial year of recovery', '47 patients [mean age 58.6 years; 38% female; 77% white']","['MBSR group intervention or usual care', 'MBSR', 'Mindfulness-Based Stress Reduction', 'Mindfulness-based stress reduction (MBSR', 'exercise-based cardiac rehabilitation (CR']","['depression, anxiety, perceived stress, health related quality of life (HRQOL), blood pressure, biomarkers (lipids, HbA1c, CRP) and 24-hour Holter monitoring', 'worsening of most CV risk factors', 'depression', 'psychosocial and CV outcomes', 'anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0588006', 'cui_str': 'Mild depression (disorder)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0013801', 'cui_str': 'Monitoring, Holter'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",47.0,0.0623392,This pilot RCT provides preliminary evidence of MBSR's potential to improve short term psychosocial well-being in cardiac patients during their first year of recovery.,"[{'ForeName': 'Prabhjot S', 'Initials': 'PS', 'LastName': 'Nijjar', 'Affiliation': 'Cardiovascular Division, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA. nijja003@umn.edu.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connett', 'Affiliation': 'Biostatistics, Epidemiology and Research Design (BERD), University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lindquist', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Biostatistics, Epidemiology and Research Design (BERD), University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Burt', 'Affiliation': 'Cardiac Rehabilitation, Fairview Health Services, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Pergolski', 'Affiliation': 'Cardiac Rehabilitation, Fairview Health Services, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Wolfe', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Balaji', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Chandiramani', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Kreitzer', 'Affiliation': 'Earl E Bakken Center for Spirituality & Healing, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Everson-Rose', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}]",Scientific reports,['10.1038/s41598-019-54932-2']
3158,32438300,Efficacy of 4 wk of home enteral feeding supplementation after esophagectomy on immune function: A randomized controlled trial.,"OBJECTIVES


In recent years, home enteral nutrition (HEN) has been adopted as a feasible and safe form of nutrition for patients undergoing esophagectomy. The aim of this study was to compare the effects of 4 wk of HEN with standard enteral nutrition (SEN) on immune function, nutritional status, and survival in patients undergoing esophagectomy.
METHODS


A parallel-group, randomized, single-blind, clinical trial was conducted between April 1 and August 1, 2017. Eighty patients were enrolled in the study and 62 were eligible for analysis. An enteral feeding pump was used to infuse enteral nutrition via jejunostomy tube postoperatively. Patients in HEN group were instructed to independently administer jejunostomy feeds at home. Immune parameters and nutritional indicators were measured at preoperative day 7 and at postoperative day 30.
RESULTS


There were no significant differences in baseline characteristics between the two groups. The levels of immunoglobulin (Ig)A and IgG, which can reflect a patient's immune function, significantly increased in the HEN group compared with those in the SEN group (P = 0.042 and P = 0.003, respectively). Comparing the two groups, 2-y progression-free survival and overall survival had no significant differences in survival curves (P = 0.36 and P = 0.29, respectively).
CONCLUSION


Four weeks of HEN is a safe and feasible nutritional strategy to improve immune function and nutritional status after esophagectomy. Although there was no significant difference in survival between the two groups, HEN could still be more effective and beneficial than SEN to patients with defective nutritional and immune status.",2020,"Although there was no significant difference in survival between the two groups, HEN could still be more effective and beneficial than SEN to patients with defective nutritional and immune status.","['Eighty patients were enrolled in the study and 62 were eligible for analysis', 'patients undergoing esophagectomy']","['home enteral nutrition (HEN', 'SEN', 'HEN', 'home enteral feeding supplementation', 'HEN with standard enteral nutrition (SEN']","['2-y progression-free survival and overall survival', 'levels of immunoglobulin (Ig)A and IgG', 'survival curves', 'immune function and nutritional status', 'survival', 'immune function, nutritional status, and survival', 'Immune parameters and nutritional indicators', 'immune function']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",80.0,0.113342,"Although there was no significant difference in survival between the two groups, HEN could still be more effective and beneficial than SEN to patients with defective nutritional and immune status.","[{'ForeName': 'Xiao-Kun', 'Initials': 'XK', 'LastName': 'Li', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Zhuang-Zhuang', 'Initials': 'ZZ', 'LastName': 'Cong', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Wen-Jie', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': 'Department of Clinical Medicine, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Sai-Guang', 'Initials': 'SG', 'LastName': 'Ji', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, Bengbu Medical College, Anhui, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, Jingling School of Clinical Medicine, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Kai-Chao', 'Initials': 'KC', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Medicine, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, Jingling School of Clinical Medicine, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, School of Medicine, Southeast University, Nanjing, China; Department of Clinical Medicine, School of Medicine, Southeast University, Nanjing, China. Electronic address: dryishen@nju.edu.cn.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110787']
3159,32438267,Effect of exercise on knee joint contact forces in people following medial partial meniscectomy: A secondary analysis of a randomised controlled trial.,"BACKGROUND


Arthroscopic partial meniscectomy may cause knee osteoarthritis, which may be related to altered joint loading. Previous research has failed to demonstrate that exercise can reduce medial compartment knee loads following meniscectomy but has not considered muscular loading in their estimates.
RESEARCH QUESTION


What is the effect of exercise compared to no intervention on peak medial tibiofemoral joint contact force during walking using an electromyogram-driven neuromusculoskeletal model, following medial arthroscopic partial meniscectomy?
METHODS


This is a secondary analysis of a randomized controlled trial (RCT). 41 participants aged between 30-50 years with medial arthroscopic partial meniscectomy within the past 3-12 months, were randomly allocated to either a 12-week, home-based, physiotherapist-guided exercise program or to no exercise (control group). Three-dimensional lower-body motion, ground reaction forces, and surface electromyograms from eight lower-limb muscles were acquired during self-selected normal- and fast-paced walking at baseline and follow-up. An electromyogram-driven neuromusculoskeletal model estimated medial compartment contact forces (body weight). Linear regression models evaluated between-group differences (mean difference (95% CI)).
RESULTS


There were no significant between-group differences in the change (follow-up minus baseline) in first peak medial contact force during self-selected normal- or fast-paced walking (0.07 (-0.08 to 0.23), P = 0.34 and 0.01 (-0.19 to 0.22), P = 0.89 respectively). No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02 (-0.17 to 0.22), P = 0.81 respectively). At the individual level, variability was observed for changes in first (range -26.2% to +31.7%) and second (range -46.5% to +59.9%) peak tibiofemoral contact force.
SIGNIFICANCE


This is the first study to apply electromyogram-driven neuromusculoskeletal modelling to an exercise intervention in a RCT. While our results suggest that a 12-week exercise program does not alter peak medial knee loads after meniscectomy, within-participant variability suggests individual-specific muscle activation patterns that warrant further investigation.",2020,"No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02","['41 participants aged between 30-50 years with medial arthroscopic partial meniscectomy within the past 3-12 months', 'people following medial partial meniscectomy']","['exercise intervention', 'physiotherapist-guided exercise program or to no exercise (control group', 'exercise']","['knee joint contact forces', 'peak medial knee loads', 'change in second peak medial contact force during normal- or fast-paced walking', 'peak tibiofemoral contact force', 'peak medial contact force during self-selected normal- or fast-paced walking']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",41.0,0.0930649,"No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02","[{'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Starkey', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Gavin K', 'Initials': 'GK', 'LastName': 'Lenton', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Saxby', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wrigley', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lloyd', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia. Electronic address: halm@unimelb.edu.au.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.025']
3160,32438250,Ante-and post-mortem strategies to improve the meat quality of high-value muscles harvested from farmed male common eland (Taurotragus oryx).,"The effects of immunocastration, pelvic suspension and wet ageing on the meat quality of the longissimus lumborum et thoracis (LTL) and biceps femoris (BF) muscles of male common eland were evaluated. Ten subadult males were either immunocastrated (n = 5) or remained intact (n = 5) throughout a four-month growth trial, after which their carcass sides were randomly allocated to either pelvic- or Achilles-suspension. The LTL and BF were further aged for 14 days, measuring changes in the physical quality weekly. The sensory quality of the LTL and BF were determined after ageing (8/9 days, respectively). Immunocastration had minimal effects on the meat quality of male eland, but pelvic suspension decreased the shear force. All muscles reached minimum shear force after seven days of ageing, and the panellists ranked the pelvic-suspended muscles higher for tenderness traits. Incorporating pelvic suspension and wet ageing into the commercial processing of eland carcasses should be considered to improve overall meat quality.",2020,"Immunocastration had minimal effects on the meat quality of male eland, but pelvic suspension decreased the shear force.","['Ten subadult males were either immunocastrated (n\xa0=\xa05) or remained intact (n\xa0=\xa05) throughout a four-month growth trial, after which their carcass sides', 'high-value muscles harvested from farmed male common eland (Taurotragus oryx']","['pelvic- or Achilles-suspension', 'immunocastration, pelvic suspension and wet ageing']","['meat quality of the longissimus lumborum et thoracis (LTL) and biceps femoris (BF) muscles', 'sensory quality of the LTL and BF', 'overall meat quality']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0325245', 'cui_str': 'Taurotragus oryx'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0205381', 'cui_str': 'Wet'}]","[{'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0224306', 'cui_str': 'Structure of longissimus muscle'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",10.0,0.0142914,"Immunocastration had minimal effects on the meat quality of male eland, but pelvic suspension decreased the shear force.","[{'ForeName': 'Tersia', 'Initials': 'T', 'LastName': 'Needham', 'Affiliation': 'Department of Animal Science and Food Processing, Faculty of Tropical AgriSciences, Czech University of Life Sciences Prague, Kamýcká 129, Prague, Suchdol 165 00, Czech Republic. Electronic address: needham@ftz.czu.cz.'}, {'ForeName': 'Radim', 'Initials': 'R', 'LastName': 'Kotrba', 'Affiliation': 'Department of Animal Science and Food Processing, Faculty of Tropical AgriSciences, Czech University of Life Sciences Prague, Kamýcká 129, Prague, Suchdol 165 00, Czech Republic; Department of Ethology, Institute of Animal Science, Přátelství 815, Prague 10- Uhříněves, 104 00, Czech Republic.'}, {'ForeName': 'Louwrens C', 'Initials': 'LC', 'LastName': 'Hoffman', 'Affiliation': 'Department of Animal Sciences, University of Stellenbosch, Private Bag X1, Matieland, Stellenbosch 7602, South Africa; Centre for Nutrition and Food Sciences, Queensland Alliance for Agriculture and Food Innovation (QAAFI), The University of Queensland, Health and Food Sciences Precinct, 39 Kessels Rd, Coopers Plains 4108. Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bureš', 'Affiliation': 'Department of Cattle Breeding, Institute of Animal Science, Přátelství 815, Prague 10- Uhříněves, 104 00, Czech Republic; Department of Food Quality, Faculty of Agrobiology, Food and Natural Sciences, Czech University of Life Sciences Prague, Kamýcká 129, Prague, Suchdol 165 00, Czech Republic.'}]",Meat science,['10.1016/j.meatsci.2020.108183']
3161,32438316,Using simulation to teach undergraduate nursing and midwifery students research design.,"Whilst it is widely accepted that the ability to critique, interpret and integrate research is an integral part of the evidence-based practice of nursing and midwifery, teaching such skills to undergraduate students is equally recognised as challenging. From a student's perspective the theoretical aspects, concepts and language of research design may seem far removed from the imperative of developing skills and gaining clinical experience. Simulation has been widely demonstrated as an effective pedagogical approach to engage students in learning and developing practical skills. The 'hands-on' approach provides a cognitive link between theory and practice that is immediately relevant to the student. Simulation training has also been used in other areas of healthcare such as communication and ethics. However, the use of simulation to demonstrate the theoretical and practical aspects of research design to midwifery and nursing students has not been explored. This paper describes a novel approach to teaching undergraduate students fundamental concepts of randomised controlled trial design through their participation in a simulated research trial. Students experienced aspects such as consent, randomisation, intervention, data collection, analysis and interpretation. Post workshop evaluations suggest that students found the approach engaging, increased their knowledge and understanding of research and evidenced-based practice.",2020,"Post workshop evaluations suggest that students found the approach engaging, increased their knowledge and understanding of research and evidenced-based practice.",[],['Simulation training'],[],[],"[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}]",[],,0.0187677,"Post workshop evaluations suggest that students found the approach engaging, increased their knowledge and understanding of research and evidenced-based practice.","[{'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Chamberlain Building University of Queensland, St Lucia, 4072, Queensland, Australia. Electronic address: nigel.lee@uq.edu.au.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Peacock', 'Affiliation': 'Chamberlain Building University of Queensland, St Lucia, 4072, Queensland, Australia. Electronic address: a.peacock2@uq.edu.au.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102804']
3162,32438301,Preoperative fasting abbreviation (Enhanced Recovery After Surgery protocol) and its effects on the metabolism of patients undergoing gynecologic surgeries under spinal anesthesia: A randomized clinical trial.,"OBJECTIVES


Recommended perioperative nutritional interventions may contribute to satisfactory surgical outcomes. Each moment in the course of a surgical pathologic condition may be a window of opportunity for an intervention with a positive impact on postoperative recovery. Based on the idea of accelerating postoperative recovery, the objective of this study was to evaluate the effectiveness of a nutritional intervention with preoperative fasting abbreviation (Enhanced Recovery After Surgery recommendations) on the metabolism of patients undergoing gynecologic surgeries under spinal anesthesia.
METHODS


This randomized clinical trial was performed at a hospital of medium complexity. After Human Research Ethics Committee approval on August 24, 2015, 80 women who had gynecologic surgery in the period from January to June 2016 and signed the consent form were randomly allocated into two groups: a control group (n = 42) and a juice group (n = 38). They received 200 mL of inert solution (control group) or liquid enriched with carbohydrate and protein (juice group) 4 h before surgery. The variables studied were serum glucose, insulin, insulin resistance evaluated by the homeostatic model assessment of insulin resistance (HOMA-IR), C-reactive protein, and albumin in the pre- and postoperative periods. The statistical analysis was performed with SPSS 20.0.
RESULTS


There was a statistically significant difference in the coefficient of variation for the HOMA-IR index in the control group (17.27%; P < 0.01) compared with the juice group (8.46%; P < 0.05), which remained stable from the pre- to the postoperative period.
CONCLUSIONS


Preoperative fasting abbreviation with liquid containing carbohydrate and protein before gynecologic surgeries may provide metabolic stability with lower variation in insulin resistance than inert solution.",2020,"There was a statistically significant difference in the coefficient of variation for the HOMA-IR index in the control group (17.27%; P < 0.01) compared with the juice group (8.46%; P < 0.05), which remained stable from the pre- to the postoperative period.
","['80 women who had gynecologic surgery in the period from January to June 2016 and signed the consent', 'patients undergoing gynecologic surgeries under spinal anesthesia']",['200 mL of inert solution (control group) or liquid enriched with carbohydrate and protein (juice group) 4 h before surgery'],"['serum glucose, insulin, insulin resistance evaluated by the homeostatic model assessment of insulin resistance (HOMA-IR), C-reactive protein, and albumin in the pre- and postoperative periods', 'Preoperative fasting abbreviation', 'HOMA-IR index']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0000723', 'cui_str': 'Abbreviation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0703072,"There was a statistically significant difference in the coefficient of variation for the HOMA-IR index in the control group (17.27%; P < 0.01) compared with the juice group (8.46%; P < 0.05), which remained stable from the pre- to the postoperative period.
","[{'ForeName': 'Gisele Vissoci', 'Initials': 'GV', 'LastName': 'Marquini', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo, São Paulo, Brazil. Electronic address: giselemarquini@gmail.com.'}, {'ForeName': 'Francisco Edes', 'Initials': 'FE', 'LastName': 'da Silva Pinheiro', 'Affiliation': 'Hospital and Municipal Maternity Dr. Odelmo Leão Carneiro, Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Alfredo Urbano', 'Initials': 'AU', 'LastName': 'da Costa Vieira', 'Affiliation': 'Hospital and Municipal Maternity Dr. Odelmo Leão Carneiro, Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Rogério Melo', 'Initials': 'RM', 'LastName': 'da Costa Pinto', 'Affiliation': 'Faculty of Maths, Nucleus of Statistical and Biometrical Studies, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Maria Gabriela Baumgarten', 'Initials': 'MGB', 'LastName': 'Kuster Uyeda', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Manoel João Batista Castello', 'Initials': 'MJBC', 'LastName': 'Girão', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marair Gracio Ferreira', 'Initials': 'MGF', 'LastName': 'Sartori', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo, São Paulo, Brazil.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110790']
3163,31415087,"Treatment of Menopausal Vasomotor Symptoms With Fezolinetant, a Neurokinin 3 Receptor Antagonist: A Phase 2a Trial.","CONTEXT


The thermoregulatory center in the hypothalamus is stimulated by neurokinin 3 receptor (NK3R) activation and inhibited by estrogen-negative feedback. This balance is disrupted in menopause, producing vasomotor symptoms (VMSs).
OBJECTIVE


To evaluate safety and efficacy of the NK3R antagonist fezolinetant in menopausal VMSs.
DESIGN


Twelve-week, double-blind, randomized, placebo-controlled study.
SETTING


Eight Belgian centers from September 2015 to October 2016.
PARTICIPANTS


Generally healthy menopausal women aged 40 to 65 years with moderate/severe VMSs.
INTERVENTIONS


Subjects were randomized (1:1) to 90 mg of fezolinetant twice daily or placebo for 12 weeks.
MAIN OUTCOME MEASURES


Subjects captured VMS severity and frequency using an electronic diary. The primary outcome was change from baseline to week 12 in total VMS score with fezolinetant vs placebo. Secondary outcomes included timing of changes in frequency and severity of moderate/severe VMSs and quality-of-life assessments at weeks 4, 8, and 12. Pharmacodynamic and pharmacokinetic effects were assessed, as were safety and tolerability.
RESULTS


Of 122 subjects screened, 87 were randomized and 80 (92%) completed the study. At week 12, fezolinetant significantly reduced total VMS score vs placebo (-26.5 vs -12.2, P < 0.001) and decreased mean frequency of moderate/severe VMSs by five episodes per day vs placebo. Severity and frequency of moderate/severe VMSs were reduced from the first day of treatment. Improvements were achieved in all quality-of-life measures. Fezolinetant was well tolerated. The most common fezolinetant-related adverse event was gastrointestinal disorder (n = 6).
CONCLUSIONS


Fezolinetant rapidly and significantly reduced moderate/severe VMSs, supporting its potential as an effective nonhormonal treatment option for menopausal women.",2019,"At Week 12, fezolinetant significantly reduced total VMS score versus placebo (-26.5 versus -12.2, P<0.001) and decreased mean frequency of moderate/severe VMS by 5 episodes per day versus placebo.","['Generally healthy menopausal women aged 40-65 years with moderate/severe VMS', 'Of 122 subjects screened, 87 were randomized and 80 (92%) completed the study', 'Eight Belgian centers from September 2015 to October 2016', 'menopausal women', 'menopausal VMS']","['NK3R antagonist fezolinetant', 'placebo', 'fezolinetant 90 mg BID or placebo']","['Severity and frequency of moderate/severe VMS', 'total VMS score', 'safety and tolerability', 'mean frequency of moderate/severe VMS', 'Pharmacodynamic and pharmacokinetic effects', 'moderate/severe VMS', 'tolerated', 'frequency and severity of vasomotor symptoms and improved quality of life', 'timing of changes in frequency and severity of moderate/severe VMS and quality-of-life assessments']","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337797', 'cui_str': 'Belgians (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C4547455', 'cui_str': 'fezolinetant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",122.0,0.428607,"At Week 12, fezolinetant significantly reduced total VMS score versus placebo (-26.5 versus -12.2, P<0.001) and decreased mean frequency of moderate/severe VMS by 5 episodes per day versus placebo.","[{'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Depypere', 'Affiliation': 'Breast and Menopause Clinic, University Hospital, Ghent, Netherlands.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Timmerman', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Donders', 'Affiliation': 'Femicare vzw, Tienen, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sieprath', 'Affiliation': 'Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Ramael', 'Affiliation': 'Ogeda SA, Gosselies, Belgium.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Combalbert', 'Affiliation': 'Ogeda SA, Gosselies, Belgium.'}, {'ForeName': 'Hamid R', 'Initials': 'HR', 'LastName': 'Hoveyda', 'Affiliation': 'Ogeda SA, Gosselies, Belgium.'}, {'ForeName': 'Graeme L', 'Initials': 'GL', 'LastName': 'Fraser', 'Affiliation': 'Ogeda SA, Gosselies, Belgium.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00677']
3164,32438481,Intravesical Prostatic Protrusion does not compromise therapeutic effects of Mirabegron in male patients with overactive bladder.,"AIMS


Intravesical prostatic protrusion (IPP) is associated with degree of benign prostatic obstruction (BPO). We evaluated the effects of Mirabegron, a selective β3 adrenoceptor agonist, on overactive bladder (OAB) in male patients with different degrees of IPP.
METHODS


185 male patients ≥ 40 years with lower urinary tract symptoms (LUTS) were recruited from a tertiary referral center. OAB was defined by OAB symptom score urgency score of ≥2 and sum score of ≥3. IPP was measured in the mid sagittal section using transrectal ultrasound and patients were divided into IPP≤5mm and IPP>5mm groups. Outcomes were assessed at baseline, four, and twelve weeks.
RESULTS


104 patients (56.2%) were diagnosed with OAB and received Mirabegron (50mg) daily use. Both IPP groups (≤5mm and >5mm) had similar baseline OAB Symptom Scores and International Prostate Symptom Scores (IPSS). Four-week Mirabegron usage was associated with significant decreases in both symptom score measurements, OABSS: IPP≤5mm -27.4% and IPP>5mm -19.7% (p=0.419) and IPSS: -32% and -22.5% (p=0.202), respectively. Urgency, urge incontinence and nocturia sub-scores were decreased in both groups, -26.3% and -27.4% (p=0.690), 53.3% and 46.2% (p= 0.916), and 20.8% and 15.4% (p=0.958). Effects were maintained at twelve weeks. We found no significant improvement in the frequency sub-score in either group. One patient stopped medication due to intolerable hypertension. Most frequent adverse event was increased residual urine (≥ 50 ml higher than baseline), IPP≤5mm 9.2% and IPP>5mm 5.1% (p= 0.707), but no case had acute urinary retention.
CONCLUSIONS


Mirabegron is an effective drug to treat male OAB regardless of IPP grade.",2020,"Four-week Mirabegron usage was associated with significant decreases in both symptom score measurements, OABSS: IPP≤5mm -27.4% and IPP>5mm -19.7% (p=0.419) and IPSS:","['185 male patients ≥ 40 years with lower urinary tract symptoms (LUTS) were recruited from a tertiary referral center', '104 patients (56.2%) were diagnosed with OAB and received', 'male patients with overactive bladder', 'male patients with different degrees of IPP']","['Intravesical prostatic protrusion (IPP', 'Intravesical Prostatic Protrusion', 'Mirabegron']","['IPP', 'OAB', 'Urgency, urge incontinence and nocturia sub-scores', 'frequency sub-score', 'overactive bladder (OAB', 'OAB symptom score urgency score', 'IPSS', 'baseline OAB Symptom Scores and International Prostate Symptom Scores (IPSS']","[{'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0150045', 'cui_str': 'Urge incontinence of urine'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",185.0,0.0757977,"Four-week Mirabegron usage was associated with significant decreases in both symptom score measurements, OABSS: IPP≤5mm -27.4% and IPP>5mm -19.7% (p=0.419) and IPSS:","[{'ForeName': 'Yuan Chi', 'Initials': 'YC', 'LastName': 'Shen', 'Affiliation': 'Urology, DaPi Road No.123, Kaohsiung, Taiwan.'}, {'ForeName': 'Hung Jen', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Wei Chia', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Chien Hsu', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Yao-Chi', 'Initials': 'YC', 'LastName': 'Chuang', 'Affiliation': 'Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}]",International journal of clinical practice,['10.1111/ijcp.13537']
3165,31416531,Antenatal Therapy for Fetal Supraventricular Tachyarrhythmias: Multicenter Trial.,"BACKGROUND


Standardized treatment of fetal tachyarrhythmia has not been established.
OBJECTIVES


This study sought to evaluate the safety and efficacy of protocol-defined transplacental treatment for fetal supraventricular tachycardia (SVT) and atrial flutter (AFL).
METHODS


In this multicenter, single-arm trial, protocol-defined transplacental treatment using digoxin, sotalol, and flecainide was performed for singleton pregnancies from 22 to <37 weeks of gestation with sustained fetal SVT or AFL ≥180 beats/min. The primary endpoint was resolution of fetal tachyarrhythmia. Secondary endpoints were fetal death, pre-term birth, and neonatal arrhythmia. Adverse events (AEs) were also assessed.
RESULTS


A total of 50 patients were enrolled at 15 institutions in Japan from 2010 to 2017; short ventriculoatrial (VA) SVT (n = 17), long VA SVT (n = 4), and AFL (n = 29). One patient with AFL was excluded because of withdrawal of consent. Fetal tachyarrhythmia resolved in 89.8% (44 of 49) of cases overall and in 75.0% (3 of 4) of cases of fetal hydrops. Pre-term births occurred in 20.4% (10 of 49) of patients. Maternal AEs were observed in 78.0% (39 of 50) of patients. Serious AEs occurred in 1 mother and 4 fetuses, thus resulting in discontinuation of protocol treatment in 4 patients. Two fetal deaths occurred, mainly caused by heart failure. Neonatal tachyarrhythmia was observed in 31.9% (15 of 47) of neonates within 2 weeks after birth.
CONCLUSIONS


Protocol-defined transplacental treatment for fetal SVT and AFL was effective and tolerable in 90% of patients. However, it should be kept in mind that serious AEs may take place in fetuses and that tachyarrhythmias may recur within the first 2 weeks after birth.",2019,"Neonatal tachyarrhythmia was observed in 31.9% (15 of 47) of neonates within 2 weeks after birth.
","['singleton pregnancies from 22 to\xa0<37\xa0weeks of gestation with sustained fetal SVT or AFL\xa0≥180 beats/min', '50 patients were enrolled at 15 institutions in Japan from 2010 to 2017; short ventriculoatrial (VA) SVT (n\xa0=\xa017), long VA SVT (n\xa0=\xa04), and AFL (n\xa0=\xa029']","['protocol-defined transplacental treatment', 'Antenatal Therapy', 'digoxin, sotalol, and flecainide']","['resolution of fetal tachyarrhythmia', 'safety and efficacy', 'Serious AEs', 'Neonatal tachyarrhythmia', 'fetal death, pre-term birth, and neonatal arrhythmia', 'heart failure', 'term births', 'Fetal tachyarrhythmia', 'fetal supraventricular tachycardia (SVT) and atrial flutter (AFL', 'Adverse events (AEs', 'Maternal AEs']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia (disorder)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0442375', 'cui_str': 'Transplacental approach (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0037707', 'cui_str': 'Sotalol'}, {'cui': 'C0016229', 'cui_str': 'Flecainide'}]","[{'cui': 'C3830147', 'cui_str': 'Foetal tachyarrhythmia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0015927', 'cui_str': 'Fetal Demise'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0233324', 'cui_str': 'Term Birth'}, {'cui': 'C1533637', 'cui_str': 'Neonatal dysrhythmia (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1096628', 'cui_str': 'Foetal supraventricular tachycardia'}, {'cui': 'C0004239', 'cui_str': 'Auricular Flutter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",,0.0951027,"Neonatal tachyarrhythmia was observed in 31.9% (15 of 47) of neonates within 2 weeks after birth.
","[{'ForeName': 'Takekazu', 'Initials': 'T', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Perinatology and Gynecology, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Yasuki', 'Initials': 'Y', 'LastName': 'Maeno', 'Affiliation': 'Department of Pediatrics and Child Health, Kurume University School of Medicine, Kurume, Japan. Electronic address: yasukim@med.kurume-u.ac.jp.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Hamasaki', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Inamura', 'Affiliation': ""Department of Pediatric Cardiology, Osaka Women's and Children's Hospital, Izumi, Japan.""}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yasukochi', 'Affiliation': ""Department of Cardiology, Nagano Children's Hospital, Azumino, Japan.""}, {'ForeName': 'Motoyoshi', 'Initials': 'M', 'LastName': 'Kawataki', 'Affiliation': 'Department of Gynecology and Obstetrics, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Horigome', 'Affiliation': 'Department of Pediatrics, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Yoda', 'Affiliation': 'Department of Neonatology, Toho University Omori Medical Center, Tokyo, Japan.'}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Taketazu', 'Affiliation': 'Department of Pediatric Cardiology, Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Nii', 'Affiliation': ""Department of Cardiology, Shizuoka Children's Hospital, Shizuoka, Japan.""}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Internal Medicine, Kanagawa Children's Medical Center, Yokohama, Japan.""}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': 'Department of Pediatric Cardiology, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Pediatric Cardiology, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Heima', 'Initials': 'H', 'LastName': 'Sakaguchi', 'Affiliation': 'Department of Pediatric Cardiology, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ueda', 'Affiliation': 'Department of Perinatology and Gynecology, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Katsuragi', 'Affiliation': 'Department of Perinatology and Gynecology, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Advanced Medical Technology Development, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Sago', 'Affiliation': 'Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Ikeda', 'Affiliation': 'Department of Obstetrics and Gynecology, Mie University, Tsu, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.06.024']
3166,32141273,A randomized controlled pilot trial of sleep health education on body composition changes following 10 weeks' resistance exercise.,"BACKGROUND


The purpose of this study was to investigate the effect of advising sleep health optimization on anthropomorphic variables following 10 weeks resistance exercise training.
METHODS


Thirty untrained healthy men were recruited for the study and 23 were included in the final analysis. Participants were randomly assigned to exercise and sleep optimization: ExS (N.=10) or exercise only: Ex (N.=12). Both groups performed a whole-body resistance exercise program twice a week for 10 weeks. The ExS group received sleep health (SH) education on how to improve both sleep quantity and quality.
RESULTS


After 10 weeks of training both groups had increased lean body mass by a similar amount. The ExS group experienced an increase of 1.7±1.1 kg while the Ex group experienced an increase of 1.3±0.8 kg (P=0.29 for difference between groups). The men in the ExS group reduced fat mass significantly (-1.8±0.8 kg) while the Ex group did not (0.8±1.0 kg). P value was 0.02 for difference between groups.
CONCLUSIONS


This randomized controlled trial suggests that combining regular resistance exercise training with optimization of sleep health provide significant added benefits to body composition. This optimization provides a simple and cheap tool, applicable to the general healthy population.",2020,The men in the ExS group reduced fat mass significantly (-1.8kg ± 0.8kg) while the Ex group did not (0.8kg ± 1.0kg).,"['general healthy population', '30 untrained healthy men were recruited for the study and 23 were included in the final analysis']","['regular resistance exercise training', 'whole body resistance exercise program', 'exercise and sleep optimization: ExS (n=10) or exercise only: Ex', 'sleep health education', 'resistance exercise training', 'sleep health (SH) education', 'advising sleep health optimization']","['lean body mass', 'body composition changes', 'sleep quantity and quality', 'fat mass']","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0018701'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",30.0,0.0757375,The men in the ExS group reduced fat mass significantly (-1.8kg ± 0.8kg) while the Ex group did not (0.8kg ± 1.0kg).,"[{'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Jåbekk', 'Affiliation': 'Department of Primary and Secondary Teacher Education, Faculty of Education and International Studies, Oslo Metropolitan University, Oslo, Norway - jabekk@oslomet.no.'}, {'ForeName': 'Rein M', 'Initials': 'RM', 'LastName': 'Jensen', 'Affiliation': 'Department of Primary and Secondary Teacher Education, Faculty of Education and International Studies, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Sandell', 'Affiliation': 'Department of Primary and Secondary Teacher Education, Faculty of Education and International Studies, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Haugen', 'Affiliation': 'Department of Primary and Secondary Teacher Education, Faculty of Education and International Studies, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Line M', 'Initials': 'LM', 'LastName': 'Katralen', 'Affiliation': 'Department of Primary and Secondary Teacher Education, Faculty of Education and International Studies, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Bjorvatn', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10136-1']
3167,31150120,A randomized phase 3 trial comparing nimotuzumab plus cisplatin chemoradiotherapy versus cisplatin chemoradiotherapy alone in locally advanced head and neck cancer.,"BACKGROUND


Because the addition of nimotuzumab to chemoradiation in patients with locally advanced head and neck cancer improved outcomes in a phase 2 study, the authors conducted a phase 3 study to confirm these findings.
METHODS


This open-label, investigator-initiated, phase 3, randomized trial was conducted from 2012 to 2018. Adult patients with locally advanced head and neck cancer who were fit for radical chemoradiation were randomized 1:1 to receive either radical radiotherapy (66-70 grays) with concurrent weekly cisplatin (30 mg/m 2  ) (CRT) or the same schedule of CRT with weekly nimotuzumab (200 mg) (NCRT).The primary endpoint was progression-free survival (PFS); key secondary endpoints were disease-free survival (DFS), duration of locoregional control (LRC), and overall survival (OS). An intent-to-treat analysis also was performed.
RESULTS


In total, 536 patients were allocated equally to both treatment arms. The median follow-up was 39.13 months. The addition of nimotuzumab improved PFS (hazard ratio [HR], 0.69; 95% CI, 0.53-0.89; P = .004), LRC (HR, 0.67; 95% CI, 0.50-0.89; P = .006), and DFS (HR, 0.71; 95% CI, 0.55-0.92; P = .008) and had a trend toward improved OS (HR, 0.84; 95% CI, 0.65-1.08; P = .163). Grade 3 through 5 adverse events were similar between the 2 arms, except for a higher incidence of mucositis in the NCRT arm (66.7% vs 55.8%; P = .01).
CONCLUSIONS


The addition of nimotuzumab to concurrent weekly CRT improves PFS, LRC, and DFS. This combination provides a novel alternative therapeutic option to a 3-weekly schedule of 100 mg/m 2  cisplatin in patients with locally advanced head and neck cancer who are treated with radical-intent CRT.",2019,"Grade 3 through 5 adverse events were similar between the 2 arms, except for a higher incidence of mucositis in the NCRT arm (66.7% vs 55.8%; P = .01).
","['patients with locally advanced head and neck cancer', 'patients with locally advanced head and neck cancer who are treated with radical-intent CRT', '536 patients', 'locally advanced head and neck cancer', 'Adult patients with locally advanced head and neck cancer who were fit for radical chemoradiation']","['concurrent weekly cisplatin', 'cisplatin', 'cisplatin chemoradiotherapy alone', 'CRT with weekly nimotuzumab', 'radical radiotherapy', 'nimotuzumab to chemoradiation', 'nimotuzumab plus cisplatin chemoradiotherapy']","['PFS, LRC, and DFS', 'disease-free survival (DFS), duration of locoregional control (LRC), and overall survival (OS', 'Grade 3 through 5 adverse events', 'PFS', 'mucositis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1570308', 'cui_str': 'nimotuzumab'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}]",536.0,0.15947,"Grade 3 through 5 adverse events were similar between the 2 arms, except for a higher incidence of mucositis in the NCRT arm (66.7% vs 55.8%; P = .01).
","[{'ForeName': 'Vijay Maruti', 'Initials': 'VM', 'LastName': 'Patil', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Jaiprakash', 'Initials': 'J', 'LastName': 'Agarwal', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Sarbani', 'Initials': 'S', 'LastName': 'Ghosh-Laskar', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Budrukkar', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Vedang', 'Initials': 'V', 'LastName': 'Murthy', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Tejpal', 'Initials': 'T', 'LastName': 'Gupta', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Mahimkar', 'Affiliation': 'Mahimkar Laboratory, Advanced Center for Treatment, Research, and Education in Cancer, Navi Mumbai, India.'}, {'ForeName': 'Shashikant', 'Initials': 'S', 'LastName': 'Juvekar', 'Affiliation': 'Department of Radiology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Supreeta', 'Initials': 'S', 'LastName': 'Arya', 'Affiliation': 'Department of Radiology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Department of Radiology, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Archi', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Nuclear Medicine, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Nilendu', 'Initials': 'N', 'LastName': 'Purandare', 'Affiliation': 'Department of Nuclear Medicine, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Rangarajan', 'Affiliation': 'Department of Nuclear Medicine, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Balaji', 'Affiliation': 'Department of Speech and Therapy, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Sameer Vasant', 'Initials': 'SV', 'LastName': 'Chaudhari', 'Affiliation': 'Biocon Ltd, Bengaluru, India.'}, {'ForeName': 'Shripad', 'Initials': 'S', 'LastName': 'Banavali', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Sadhana', 'Initials': 'S', 'LastName': 'Kannan', 'Affiliation': 'Department of Biostatistics, Advanced Center for Treatment, Research, and Education in Cancer, Navi Mumbai, India.'}, {'ForeName': 'Atanu', 'Initials': 'A', 'LastName': 'Bhattacharjee', 'Affiliation': 'Department of Epidemiology, Advanced Center for Treatment, Research, and Education in Cancer, Navi Mumbai, India.'}, {'ForeName': 'Anil K', 'Initials': 'AK', 'LastName': ""D'Cruz"", 'Affiliation': 'Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Chaturvedi', 'Affiliation': 'Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Prathamesh S', 'Initials': 'PS', 'LastName': 'Pai', 'Affiliation': 'Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Devendra', 'Initials': 'D', 'LastName': 'Chaukar', 'Affiliation': 'Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Gouri', 'Initials': 'G', 'LastName': 'Pantvaidya', 'Affiliation': 'Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Nair', 'Affiliation': 'Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': 'Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Deshmukh', 'Affiliation': 'Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Shivakumar', 'Initials': 'S', 'LastName': 'Thiagarajan', 'Affiliation': 'Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India.'}, {'ForeName': 'Vijayalakshmi', 'Initials': 'V', 'LastName': 'Mathrudev', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Manjrekar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Dhumal', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Kamesh', 'Initials': 'K', 'LastName': 'Maske', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Arti Sanjay', 'Initials': 'AS', 'LastName': 'Bhelekar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Nawale', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Chandrasekharan', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Pande', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Goel', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Talreja', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Vijai', 'Initials': 'V', 'LastName': 'Simha', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Sujay', 'Initials': 'S', 'LastName': 'Srinivas', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Swami', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Dilip Harindran', 'Initials': 'DH', 'LastName': 'Vallathol', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Hollis', 'Initials': 'H', 'LastName': 'Dsouza', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Shrirangwar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Turkar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Abraham', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Aditi Harsh', 'Initials': 'AH', 'LastName': 'Thanky', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Patel', 'Affiliation': 'Mahimkar Laboratory, Advanced Center for Treatment, Research, and Education in Cancer, Navi Mumbai, India.'}, {'ForeName': 'Manish Kumar', 'Initials': 'MK', 'LastName': 'Pandey', 'Affiliation': 'Mahimkar Laboratory, Advanced Center for Treatment, Research, and Education in Cancer, Navi Mumbai, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.'}]",Cancer,['10.1002/cncr.32179']
3168,32438401,Mycoprotein ingestion stimulates protein synthesis rates to a greater extent than milk protein in rested and exercised skeletal muscle of healthy young men: a randomized controlled trial.,"BACKGROUND


Mycoprotein is a fungal-derived sustainable protein-rich food source, and its ingestion results in systemic amino acid and leucine concentrations similar to that following milk protein ingestion.
OBJECTIVE


We assessed the mixed skeletal muscle protein synthetic response to the ingestion of a single bolus of mycoprotein compared with a leucine-matched bolus of milk protein, in rested and exercised muscle of resistance-trained young men.
METHODS


Twenty resistance-trained healthy young males (age: 22 ± 1 y, body mass: 82 ± 2 kg, BMI: 25 ± 1 kg·m-2) took part in a randomized, double-blind, parallel-group study. Participants received primed, continuous infusions of L-[ring-2H5]phenylalanine and ingested either 31 g (26.2 g protein: 2.5 g leucine) milk protein (MILK) or 70 g (31.5 g protein: 2.5 g leucine) mycoprotein (MYCO) following a bout of unilateral resistance-type exercise (contralateral leg acting as resting control). Blood and m. vastus lateralis muscle samples were collected before exercise and protein ingestion, and following a 4-h postprandial period to assess mixed muscle fractional protein synthetic rates (FSRs) and myocellular signaling in response to the protein beverages in resting and exercised muscle.
RESULTS


Mixed muscle FSRs increased following MILK ingestion (from 0.036 ± 0.008 to 0.052 ± 0.006%·h-1 in rested, and 0.035 ± 0.008 to 0.056 ± 0.005%·h-1 in exercised muscle; P <0.01) but to a greater extent following MYCO ingestion (from 0.025 ± 0.006 to 0.057 ± 0.004%·h-1 in rested, and 0.024 ± 0.007 to 0.072 ± 0.005%·h-1 in exercised muscle; P <0.0001) (treatment × time interaction effect; P <0.05). Postprandial FSRs trended to be greater in MYCO compared with MILK (0.065 ± 0.004 compared with 0.054 ± 0.004%·h-1, respectively; P = 0.093) and the postprandial rise in FSRs was greater in MYCO compared with MILK (Delta 0.040 ± 0.006 compared with Delta 0.018 ± 0.005%·h-1, respectively; P <0.01).
CONCLUSIONS


The ingestion of a single bolus of mycoprotein stimulates resting and postexercise muscle protein synthesis rates, and to a greater extent than a leucine-matched bolus of milk protein, in resistance-trained young men. This trial was registered at clinicaltrials.gov as 660065600.",2020,"Postprandial FSRs trended to be greater in MYCO compared with MILK (0.065 ± 0.004 compared with 0.054 ± 0.004%·h-1, respectively; P = 0.093) and the postprandial rise in FSRs was greater in MYCO compared with MILK (Delta 0.040 ± 0.006 compared with Delta 0.018 ± 0.005%·h-1, respectively; P <0.01).
","['resistance-trained young men', 'healthy young men', 'Twenty resistance-trained healthy young males (age: 22\xa0±\xa01 y, body mass: 82\xa0±\xa02 kg, BMI: 25\xa0±\xa01 kg·m-2']","['Mycoprotein ingestion', 'leucine) mycoprotein (MYCO) following a bout of unilateral resistance-type exercise (contralateral leg acting as resting control', 'L-[ring-2H5]phenylalanine and ingested either 31 g (26.2 g protein: 2.5 g leucine) milk protein (MILK) or 70 g', 'leucine-matched bolus of milk protein']","['MILK ingestion', 'postprandial rise in FSRs', 'Postprandial FSRs']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C2347312', 'cui_str': 'Mycoprotein'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0026138', 'cui_str': 'Milk protein'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0026138', 'cui_str': 'Milk protein'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",,0.118269,"Postprandial FSRs trended to be greater in MYCO compared with MILK (0.065 ± 0.004 compared with 0.054 ± 0.004%·h-1, respectively; P = 0.093) and the postprandial rise in FSRs was greater in MYCO compared with MILK (Delta 0.040 ± 0.006 compared with Delta 0.018 ± 0.005%·h-1, respectively; P <0.01).
","[{'ForeName': 'Alistair J', 'Initials': 'AJ', 'LastName': 'Monteyne', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Mariana Oc', 'Initials': 'MO', 'LastName': 'Coelho', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Porter', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch & Shriners Hospital for Children, Galveston, TX, USA.'}, {'ForeName': 'Doaa R', 'Initials': 'DR', 'LastName': 'Abdelrahman', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch & Shriners Hospital for Children, Galveston, TX, USA.'}, {'ForeName': 'Thomas So', 'Initials': 'TS', 'LastName': 'Jameson', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Jackman', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Blackwell', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Tim Ja', 'Initials': 'TJ', 'LastName': 'Finnigan', 'Affiliation': 'Marlow Foods Ltd, Stokesly, North Yorkshire, UK.'}, {'ForeName': 'Francis B', 'Initials': 'FB', 'LastName': 'Stephens', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Marlou L', 'Initials': 'ML', 'LastName': 'Dirks', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Wall', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa092']
3169,32438407,Thrombosis in Patients with Myeloma Treated in the Myeloma IX and Myeloma XI Phase III Randomized Controlled Trials.,"Newly diagnosed multiple myeloma (NDMM) patients treated with immunomodulatory drugs (IMiDs) are at high venous thrombosis (VTE) risk, but data are lacking from large prospective cohorts. We present thrombosis outcome data from Myeloma IX (n=1936) and Myeloma XI (n=4358), phase III randomized controlled trials for NDMM, treating transplant-eligible and ineligible patients before and after publication of thrombosis prevention guidelines. In Myeloma IX, compared to CTD (cyclophosphamide, thalidomide and dexamethasone), transplant-eligible patients randomized to CVAD induction (cyclophosphamide, vincristine, doxorubicin and dexamethasone) had higher VTE risk (22.5%(n=121/538) vs 16.1%(n=89/554), aHR:1.46,95%CI:1.11-1.93). For transplant-ineligible patients, compared to MP (melphalan and prednisolone), patients randomized to CTDa (attenuated CTD) induction had higher VTE risk (16.0%(n=68/425) vs 4.1%(n=17/419), aHR:4.25,95%CI:2.50-7.20). In Myeloma XI, there was no difference in VTE or arterial thrombosis risk between transplant-eligible pathways, CRD (cyclophosphamide, lenalidomide and dexamethasone) and CTD (VTE:12.2%(n=124/1014) vs 13.2%(n=133/1008), aHR:0.92,95%CI:0.72-1.18; arterial events:1.2%(n=12/1014) vs 1.5%(n=15/1008), aHR:0.80,95%CI:0.37-1.70). For transplant-ineligible patients, there was no difference in VTEs between CRDa (attenuated CRD) and CTDa (10.4%(n=95/916) vs 10.7%(n=97/910), aHR:0.97, 95%CI:0.73-1.29). However, arterial risk was higher with CRDa than CTDa (3.1%(n=28/916) vs 1.6%(n=15/910), aHR:1.91,95%CI:1.02-3.57). Thrombotic events occurred almost entirely within 6m of treatment initiation. Thrombosis was not associated with inferior progression-free or overall survival (OS), apart from inferior OS for patients with arterial events (aHR:1.53, 95%CI:1.12-2.08) in Myeloma XI. The Myeloma XI trial protocol incorporated IMWG thrombosis prevention recommendations and compared to Myeloma IX, more patients were on thromboprophylaxis (80.5% vs 22.3%) with lower VTE rates for identical regimens (CTD:13.2% vs 16.1%, CTDa:10.7% vs 16.0%). However, thrombosis remained frequent in spite of IMWG-guided thromboprophylaxis, suggesting new approaches are needed.",2020,"Thrombosis was not associated with inferior progression-free or overall survival (OS), apart from inferior OS for patients with arterial events (aHR:1.53, 95%CI:1.12-2.08) in Myeloma XI.","['Patients with Myeloma Treated in the Myeloma IX and Myeloma XI', 'Newly diagnosed multiple myeloma (NDMM) patients treated with', 'Myeloma IX (n=1936) and Myeloma XI (n=4358), phase III randomized controlled trials for NDMM, treating transplant-eligible and ineligible patients before and after publication of thrombosis prevention guidelines']","['immunomodulatory drugs (IMiDs', 'CRD (cyclophosphamide, lenalidomide and dexamethasone', 'CVAD induction (cyclophosphamide, vincristine, doxorubicin and dexamethasone', 'MP (melphalan and prednisolone', 'CTD (cyclophosphamide, thalidomide and dexamethasone']","['Thrombosis', 'arterial risk', 'VTE rates', 'Thrombotic events', 'inferior progression-free or overall survival (OS', 'VTE or arterial thrombosis risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0082139', 'cui_str': 'CVAD protocol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}]","[{'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}]",,0.147899,"Thrombosis was not associated with inferior progression-free or overall survival (OS), apart from inferior OS for patients with arterial events (aHR:1.53, 95%CI:1.12-2.08) in Myeloma XI.","[{'ForeName': 'Charlotte Ann', 'Initials': 'CA', 'LastName': 'Bradbury', 'Affiliation': 'University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Craig', 'Affiliation': 'University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pawlyn', 'Affiliation': 'Institute of Cancer Research, Sutton, United Kingdom.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cairns', 'Affiliation': 'University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hockaday', 'Affiliation': 'University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Paterson', 'Affiliation': 'University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'University Hospital Southampton, Southampton, United Kingdom.'}, {'ForeName': 'John Robert', 'Initials': 'JR', 'LastName': 'Jones', 'Affiliation': 'Kings College Hospital, London, United Kingdom.'}, {'ForeName': 'Mark Trehane', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Roger G', 'Initials': 'RG', 'LastName': 'Owen', 'Affiliation': 'The Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.'}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Kaiser', 'Affiliation': 'The Institute of Cancer Research, Sutton, United Kingdom.'}, {'ForeName': 'Walter Martin', 'Initials': 'WM', 'LastName': 'Gregory', 'Affiliation': 'University of Leeds, Leeds, We, United Kingdom.'}, {'ForeName': 'Faith E', 'Initials': 'FE', 'LastName': 'Davies', 'Affiliation': 'New-York University, New-York, New York, United States.'}, {'ForeName': 'James Anthony', 'Initials': 'JA', 'LastName': 'Child', 'Affiliation': 'University of Leeds UK, Leeds, YK, United Kingdom.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Morgan', 'Affiliation': 'NYU Langone Health Care, NYC, New York, United States.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Jackson', 'Affiliation': 'Freeman Hospital, University of Newcastle, Leeds, United Kingdom.'}]",Blood,['10.1182/blood.2020005125']
3170,31056697,"Infant Pneumococcal Carriage During Influenza, RSV, and hMPV Respiratory Illness Within a Maternal Influenza Immunization Trial.","In this post-hoc analysis of midnasal pneumococcal carriage in a community-based, randomized prenatal influenza vaccination trial in Nepal with weekly infant respiratory illness surveillance, 457 of 605 (75.5%) infants with influenza, respiratory syncytial virus (RSV), or human metapneumovirus (hMPV) illness had pneumococcus detected. Pneumococcal carriage did not impact rates of lower respiratory tract disease for these 3 viruses. Influenza-positive infants born to mothers given influenza vaccine had lower pneumococcal carriage rates compared to influenza-positive infants born to mothers receiving placebo (58.1% versus 71.6%, P = 0.03). Maternal influenza immunization may impact infant acquisition of pneumococcus during influenza infection. Clinical Trials Registration. NCT01034254.",2019,"Influenza-positive infants born to mothers given influenza vaccine had lower pneumococcal carriage rates compared to infants born to placebo mothers (58.1% versus 71.6%, p=0.03).","['Nepal with weekly infant respiratory illness surveillance, 457 of 605 (75.5%) infants with influenza, RSV or hMPV illness had pneumococcus detected', 'Influenza-positive infants born to mothers given']","['Maternal influenza immunization', 'influenza vaccine', 'placebo']","['pneumococcal carriage rates', 'RSV- or hMPV']","[{'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C1258014', 'cui_str': 'Human Metapneumovirus'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C1258014', 'cui_str': 'Human Metapneumovirus'}]",,0.199023,"Influenza-positive infants born to mothers given influenza vaccine had lower pneumococcal carriage rates compared to infants born to placebo mothers (58.1% versus 71.6%, p=0.03).","[{'ForeName': 'Alastair F', 'Initials': 'AF', 'LastName': 'Murray', 'Affiliation': 'School of Medicine and Health Sciences, George Washington University, Washington, District of Columbia.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Englund', 'Affiliation': ""Seattle Children's Hospital, Washington.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kuypers', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Global Health, Milken Institute School of Public Health, George Washington University, Washington, District of Columbia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Nepal Nutrition Intervention Project - Sarlahi, Kathmandu, Nepal.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Leclerq', 'Affiliation': 'Nepal Nutrition Intervention Project - Sarlahi, Kathmandu, Nepal.'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, Seattle.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz212']
3171,32438479,Long-term results of a randomized study comparing parathyroidectomy with cinacalcet for treating tertiary hyperparathyroidism.,"Tertiary hyperparathyroidism is a common cause of hypercalcemia after kidney transplantation (KT) and has been associated with renal dysfunction, bone mineral density loss and increased risk of fracture and cardiovascular events. In a previous 12-month clinical trial we demonstrated that subtotal parathyroidectomy was more effective than cinacalcet for controlling hypercalcemia. In the current study, we retrospectively evaluate whether this effect is maintained after 5 years of follow-up. In total, 24 patients had data available at 5 years, 13 in the cinacalcet group and 11 in the parathyroidectomy group. At 5 years, 7 of 11 patients (64%) in the parathyroidectomy group and 6 of 13 patients (46%) in the cinacalcet group (p=0.44) showed normocalcemia. However, recurrence of hypercalcemia was only observed in the cinacalcet group (p=0.016). Subtotal parathyroidectomy retained a greater reduction of intact parathyroid hormone (iPTH) compared with cinacalcet group. No differences were observed in kidney function and incidence of fragility fractures between both groups. Cinacalcet was discontinued in 5 out of 13 patients. In conclusion, in kidney transplant patients with tertiary hyperparathyroidism recurrence of hypercalcemia after 5-year follow-up is more frequent in cinacalcet than after subtotal parathyroidectomy.",2020,Subtotal parathyroidectomy retained a greater reduction of intact parathyroid hormone (iPTH) compared with cinacalcet group.,"['hypercalcemia after kidney transplantation (KT', 'kidney transplant patients with tertiary hyperparathyroidism recurrence', '24 patients had data available at 5 years, 13 in the cinacalcet group and 11 in the parathyroidectomy group']","['parathyroidectomy', 'subtotal parathyroidectomy', 'Subtotal parathyroidectomy']","['recurrence of hypercalcemia', 'intact parathyroid hormone (iPTH', 'hypercalcemia', 'kidney function and incidence of fragility fractures', 'normocalcemia']","[{'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271858', 'cui_str': 'Tertiary hyperparathyroidism'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1337242', 'cui_str': 'cinacalcet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}]","[{'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0193697', 'cui_str': 'Subtotal parathyroidectomy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}]",24.0,0.0524296,Subtotal parathyroidectomy retained a greater reduction of intact parathyroid hormone (iPTH) compared with cinacalcet group.,"[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Moreno', 'Affiliation': ""Department of Surgery, Hospital Universitari de Bellvitge, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Coloma', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'José V', 'Initials': 'JV', 'LastName': 'Torregrosa', 'Affiliation': 'Nephrology and Renal Transplant Service, Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Montero', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Francos', 'Affiliation': ""Department of Surgery, Hospital Universitari de Bellvitge, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Codina', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Manonelles', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Bestard', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'García-Barrasa', 'Affiliation': ""Department of Surgery, Hospital Universitari de Bellvitge, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Melilli', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Cruzado', 'Affiliation': ""Nephrology Department, Hospital Universitari de Bellvitge, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}]",Clinical transplantation,['10.1111/ctr.13988']
3172,31414957,"Effect of acute and chronic xenon inhalation on erythropoietin, hematological parameters, and athletic performance.","This study aimed to assess the efficacy of acute subanesthetic dosages of xenon inhalation to cause erythropoiesis and determine the effect of chronic xenon dosing on hematological parameters and athletic performance. To assess the acute effects, seven subjects breathed three subanesthetic concentrations of xenon: 30% fraction of inspired xenon (Fi Xe ) for 20 min, 50% Fi Xe  for 5 min, and 70% Fi Xe  for 2 min. Erythropoietin (EPO) was measured at baseline, during, and after xenon inhalation. To determine the chronic effects, eight subjects breathed 70% Fi Xe  for 2 min on 7 consecutive days, and EPO, total blood, and plasma volume were measured. Phase II involved assessment of 12 subjects for EPO, total blood volume, maximal oxygen uptake, and 3-km time before and after random assignment to 4 wk of xenon or sham gas inhalation. Fi Xe  50% and 70% stimulated an increase in EPO at 6 h [+2.3 mIU/mL; 95% confidence interval (CI) 0.1-4.5;  P  = 0.038] and at 192 h postinhalation (+2.9 mIU/mL; 95% CI 0.6-5.1;  P  = 0.017), respectively. Seven consecutive days of dosing significantly elevated plasma volume (+491 mL; 95% CI 194-789;  P  = 0.002). Phase II showed no significant effect on EPO, hemoglobin mass, plasma volume, maximal oxygen uptake, or 3-km time. Acute exposure to subanesthetic doses of xenon caused a consistent increase in EPO, and 7 consecutive days of xenon inhalation significantly expanded plasma volume. However, this physiological response appeared to be transient, and 4 wk of xenon inhalation did not stimulate increases in plasma volume or erythropoiesis, leaving cardiorespiratory fitness and athletic performance unchanged. NEW & NOTEWORTHY  This is the first study to examine each element of the cascade by which xenon inhalation is purported to take effect, starting with measurement of the hypoxia-inducible factor effector, erythropoietin, to hemoglobin mass and blood volume and athletic performance. We found that acute exposure to xenon increased serum erythropoietin concentration, although major markers of erythropoiesis remained unchanged. While daily dosing significantly expanded plasma volume, no physiological or performance benefits were apparent following 4 wk of dosing.",2019,"Phase II showed no significant effect on EPO, hemoglobin mass, plasma volume, V̇O 2 max, or 3 km time.
",['12 subjects for'],['xenon or sham gas inhalation'],"['EPO, total blood volume, V̇O 2 max, and 3km time', 'plasma volume', 'plasma volume or erythropoiesis, leaving cardiorespiratory fitness and athletic performance', 'elevated plasma volume', 'EPO, total blood and plasma volume', 'EPO, hemoglobin mass, plasma volume, V̇O 2 max, or 3 km time', 'EPO', 'Erythropoietin, Hematological Parameters, and Athletic Performance']",[],"[{'cui': 'C0043339', 'cui_str': 'Xenon'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}]","[{'cui': 'C0429890', 'cui_str': 'Total blood volume (observable entity)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032127', 'cui_str': 'Blood Plasma Volume'}, {'cui': 'C0014819', 'cui_str': 'Erythropoiesis'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",789.0,0.0278858,"Phase II showed no significant effect on EPO, hemoglobin mass, plasma volume, V̇O 2 max, or 3 km time.
","[{'ForeName': 'Katrin A', 'Initials': 'KA', 'LastName': 'Dias', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Dallas, Dallas, Texas.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'Lawley', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Dallas, Dallas, Texas.'}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Gatterer', 'Affiliation': 'Department of Sports Science, University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Erin J', 'Initials': 'EJ', 'LastName': 'Howden', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Dallas, Dallas, Texas.'}, {'ForeName': 'Satyam', 'Initials': 'S', 'LastName': 'Sarma', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Dallas, Dallas, Texas.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Cornwell', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Hearon', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Dallas, Dallas, Texas.'}, {'ForeName': 'Mitchel', 'Initials': 'M', 'LastName': 'Samels', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Dallas, Dallas, Texas.'}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'Everding', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Dallas, Dallas, Texas.'}, {'ForeName': 'Allan Shuo-Wen', 'Initials': 'AS', 'LastName': 'Liang', 'Affiliation': 'National Defense Medical Center, School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Hendrix', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Piper', 'Affiliation': 'German Sport University Cologne, Institute of Biochemistry/Centre for Preventive Doping Research, Cologne, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Thevis', 'Affiliation': 'German Sport University Cologne, Institute of Biochemistry/Centre for Preventive Doping Research, Cologne, Germany.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Bruick', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Levine', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Dallas, Dallas, Texas.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00289.2019']
3173,32438338,"A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence of Women Living With HIV: Protocol for a Feasibility Study.","BACKGROUND


Adherence to HIV care is complex, as barriers to care are multidimensional, particularly for ethnic minority women. Mobile health (mHealth) solutions are supportive in improving HIV health care outcomes. In the United States, however, mHealth interventions are not widely implemented in public HIV clinics, and have not been customized for women. There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV (WLWH).
OBJECTIVE


This paper aims to describe a protocol investigating the feasibility of a treatment adherence mHealth intervention among WLWH. This is a two-phase, mixed methods, pilot randomized controlled trial that begins with qualitative patients interviews to inform the system design. Participants will be block randomized by language (English, Spanish, and Haitian Creole) to 1 of 2 study arms.
METHODS


Women (aged ≥18 years) followed up at the women's HIV clinic of an academic medical center, with a recent history of nonadherence to HIV care (missed appointments, unsuppressed viral load, or not taking medications as prescribed) will be enrolled. The experimental arm will receive the intervention, which includes health reminders and psychoeducational messaging, plus clinic standard of care reminders. The psychoeducational messaging will target patient-level barriers of HIV stigma and medical mistrust, and resilience as a patient-level strength. The control arm will receive the standard of care reminders only (ie, mailed appointments and automated telephone calls). All aspects of the study and intervention will be offered in the participants' preferred language. The primary outcome is the feasibility and acceptability of the study. The secondary outcomes are changes in self-reported medication adherence, depressive symptoms, HIV stigma, medical mistrust, resilience, and clinic attendance and viral suppression extracted from the participants' medical records. Data will be assessed at baseline (T0) and 2 subsequent clinic visits-approximately 3 to 4 months postbaseline (time 1; T1) and 6 to 9 months postbaseline (time 2; T2). Qualitative data will be transcribed and analyzed iteratively. Bivariate analyses will compare data by the study group (chi-square, odds ratios, and t tests). Exploratory analysis will be conducted for each outcome variable; T1 and T2 values will be compared with values at T0, by study group.
RESULTS


As of March 2020, baseline quantitative data were collected on 54 participants (28 English speakers, 14 Spanish speakers, and 12 Haitian Creole speakers). The first three focus groups (one in each of the three languages) were completed, with a total of 20 participants. The findings are currently being integrated into the beta version of the mHealth SMS/texting system.
CONCLUSIONS


The findings of this novel HIV adherence intervention may shed light on the barriers and facilitators of HIV health care, and the mechanism(s) of a mHealth intervention that is customized for ethnic minority WLWH.
CLINICALTRIAL


ClinicalTrials.gov NCT03738410; https://clinicaltrials.gov/ct2/show/NCT03738410.",2020,"There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV (WLWH).
","['54 participants (28 English speakers, 14 Spanish speakers, and 12 Haitian Creole speakers', 'minority women living with HIV (WLWH', 'ethnic minority women', ""Women (aged ≥18 years) followed up at the women's HIV clinic of an academic medical center, with a recent history of nonadherence to HIV care (missed appointments, unsuppressed viral load, or not taking medications as prescribed) will be enrolled"", 'Women Living With HIV']","['Mobile health (mHealth) solutions', 'health reminders and psychoeducational messaging, plus clinic standard of care reminders']","['feasibility and acceptability', ""changes in self-reported medication adherence, depressive symptoms, HIV stigma, medical mistrust, resilience, and clinic attendance and viral suppression extracted from the participants' medical records""]","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}]",54.0,0.132302,"There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV (WLWH).
","[{'ForeName': 'Lunthita M', 'Initials': 'LM', 'LastName': 'Duthely', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Services, Miller School of Medicine, University of Miami, P.O. Box 016960 (D-53), Miami, US.'}, {'ForeName': 'Alex P', 'Initials': 'AP', 'LastName': 'Sanchez-Covarrubias', 'Affiliation': 'Miller School of Medicine, Miami Clinical and Translational Sciences Institute (CTSI), University of Miami, Miami, US.'}, {'ForeName': 'Adhar B', 'Initials': 'AB', 'LastName': 'Mohamed', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Services, Miller School of Medicine, University of Miami, Miami, US.'}, {'ForeName': 'JoNell E', 'Initials': 'JE', 'LastName': 'Potter', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Services, Miller School of Medicine, University of Miami, Miami, US.'}]",JMIR research protocols,['10.2196/17656']
3174,31303298,"Post-partum family planning in Burkina Faso (Yam Daabo): a two group, multi-intervention, single-blinded, cluster-randomised controlled trial.","BACKGROUND


Post-partum family planning services can prevent maternal and child morbidity and mortality in low-resource settings. We assessed the effect of a family planning intervention package on modern contraceptive use at 12 months post partum in predominantly rural Burkina Faso.
METHODS


Yam Daabo was a two group, multi-intervention, single-blinded, cluster randomised controlled trial. Primary health-care centres were randomly allocated to intervention or control clusters in a 1:1 ratio with only data analysts masked to the allocation assignment. Interventions comprised refresher training for the provider, a counselling tool, supportive supervision, availability of contraceptive services 7 days a week, client appointment cards, and invitation letters for partners. The primary outcome was modern contraceptive prevalence at 12 months, and secondary outcomes were modern contraceptive prevalence at 6 weeks and 6 months post partum. Analysis was by modified intention to treat. Prevalence ratios were adjusted for cluster effects and baseline characteristics. This study was registered with the Pan-African Clinical Trials Registry (PACTR201609001784334).
FINDINGS


From July 27-Oct 17, 2016, eight clinics were randomised and 571 women were enrolled and allocated: 286 to four intervention clusters and 285 to four control clusters. Of these, 523 completed the 12-month study exit interview (260 in the intervention group, 263 in the control group) and 523 were included in the intention-to-treat analysis. At 12 months, modern contraceptive prevalence was 55% among women who received the package and 29% among those who received routine care in control clusters (adjusted prevalence ratio 1·79, 95% CI 1·30-2·47). Significant differences in modern contraceptive prevalence were also seen between intervention and control groups at 6 weeks (42% and 10%, respectively; adjusted prevalence ratio 3·88, 95% CI 1·46-10·35) and 6 months (59% and 24%, respectively; 2·31, 1·44-3·71).
INTERPRETATION


A package of six low-technology interventions, aimed at strengthening existing primary health-care services and enhancing demand for these services, can effectively increase modern contraceptive use for up to a year post partum in rural settings in Burkina Faso and has the potential to be suitable in similar settings in this country and others.
FUNDING


Government of France.",2019,"Significant differences in modern contraceptive prevalence were also seen between intervention and control groups at 6 weeks (42% and 10%, respectively; adjusted prevalence ratio 3·88, 95% CI 1·46-10·35) and 6 months (59% and 24%, respectively; 2·31, 1·44-3·71).
","['modern contraceptive use at 12 months post partum in predominantly rural Burkina Faso', 'Primary health-care centres', '523 completed the 12-month study exit interview (260 in the intervention group, 263 in the control group) and 523 were included in the intention-to-treat analysis', 'From July 27-Oct 17, 2016, eight clinics were randomised and 571 women were enrolled and allocated: 286 to four intervention clusters and 285 to four control clusters']","['family planning intervention package', 'intervention or control clusters in a 1:1 ratio with only data analysts masked to the allocation assignment']","['modern contraceptive prevalence', 'Prevalence ratios']","[{'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",523.0,0.217153,"Significant differences in modern contraceptive prevalence were also seen between intervention and control groups at 6 weeks (42% and 10%, respectively; adjusted prevalence ratio 3·88, 95% CI 1·46-10·35) and 6 months (59% and 24%, respectively; 2·31, 1·44-3·71).
","[{'ForeName': 'Nguyen Toan', 'Initials': 'NT', 'LastName': 'Tran', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland; Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology, Sydney, Australia. Electronic address: nguyen-toan.tran@unige.ch.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Seuc', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Abou', 'Initials': 'A', 'LastName': 'Coulibaly', 'Affiliation': 'Institut de Recherche en Sciences de la Santé and Institut Africain de Santé Publique, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Sihem', 'Initials': 'S', 'LastName': 'Landoulsi', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Tieba', 'Initials': 'T', 'LastName': 'Millogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé and Institut Africain de Santé Publique, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Fatou', 'Initials': 'F', 'LastName': 'Sissoko', 'Affiliation': 'Institut de Recherche en Sciences de la Santé and Institut Africain de Santé Publique, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Wambi Maurice E', 'Initials': 'WME', 'LastName': 'Yameogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé and Institut Africain de Santé Publique, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Souleymane', 'Initials': 'S', 'LastName': 'Zan', 'Affiliation': 'World Health Organization Country Office in Burkina Faso, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Cuzin-Kihl', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kiarie', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Mary Eluned', 'Initials': 'ME', 'LastName': 'Gaffield', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Thieba', 'Affiliation': 'Unité de Formation et de Recherche en Sciences de la Santé, Ouagadougou University, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Seni', 'Initials': 'S', 'LastName': 'Kouanda', 'Affiliation': 'Institut de Recherche en Sciences de la Santé and Institut Africain de Santé Publique, Ouagadougou, Burkina Faso.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30202-5']
3175,31418140,"Effects of Dipeptidyl Peptidase-4 Inhibitor Linagliptin on Left Ventricular Dysfunction in Patients with Type 2 Diabetes and Concentric Left Ventricular Geometry (the DYDA 2™ Trial). Rationale, Design, and Baseline Characteristics of the Study Population.","PURPOSE


A multicentre, randomized, double-blind, placebo-controlled, parallel-group study aimed to define the potential positive effect of dipeptidyl peptidase-4 inhibition on left ventricular systolic function (LVSF) beyond glycemic control in type 2 diabetes mellitus (T2DM) (DYDA 2™ trial).
METHODS


Individuals with fairly controlled T2DM and asymptomatic impaired LVSF were randomized in a 1:1 ratio to receive for 48 weeks either linagliptin 5 mg daily or placebo, in addition to their stable diabetes therapy. Eligibility criteria were age ≥ 40 years, history of T2DM with a duration of at least 6 months, HbA1c ≤ 8.0% (≤ 64 mmol/mol), no history or clinical signs/symptoms of cardiac disease, evidence at baseline echocardiography of concentric LV geometry (relative wall thickness ≥ 0.42), and impaired LVSF defined as midwall fractional shortening (MFS) ≤ 15%. The primary end-point was the modification from baseline to 48 weeks of MFS. As an exploratory analysis, significant changes in LV global longitudinal strain and global circumferential strain, measured by speckle tracking echocardiography, were also considered. Secondary objectives were changes in diastolic and/or in systolic longitudinal function as measured by tissue Doppler.
RESULTS


A total of 188 patients were enrolled. They were predominantly males, mildly obese, with typical insulin-resistance co-morbidities such as hypertension and dyslipidemia. Mean relative wall thickness was 0.51 ± 0.09 and mean MFS 13.3% ± 2.5.
CONCLUSIONS


DYDA 2 is the first randomized, double-blind, placebo-controlled trial to explore the effect of a dipeptidyl peptidase-4 inhibitor on LVSF in T2DM patients in primary prevention regardless of glycemic control. The main characteristics of the enrolled population are reported.
TRIAL REGISTRATION


ClinicalTrial.gov Identifier: NCT02851745.",2019,"As an exploratory analysis, significant changes in LV global longitudinal strain and global circumferential strain, measured by speckle tracking echocardiography, were also considered.","['type 2 diabetes mellitus (T2DM) (DYDA 2™ trial', 'They were predominantly males, mildly obese, with typical insulin-resistance co-morbidities such as hypertension and dyslipidemia', 'Patients with Type 2 Diabetes and Concentric Left Ventricular Geometry (the DYDA 2™ Trial', 'Eligibility criteria were age ≥', 'Individuals with fairly controlled T2DM and asymptomatic impaired LVSF', '188 patients were enrolled', '40\xa0years, history of T2DM with a duration of at least 6\xa0months, HbA1c ≤\u20098.0% ', 'T2DM patients in primary prevention regardless of glycemic control']","['placebo', 'Dipeptidyl Peptidase-4 Inhibitor Linagliptin', 'linagliptin 5\xa0mg daily or placebo', 'dipeptidyl peptidase-4 inhibition']","['Left Ventricular Dysfunction', 'midwall fractional shortening (MFS', 'no history or clinical signs/symptoms of cardiac disease, evidence at baseline echocardiography of concentric LV geometry', 'Mean relative wall thickness', 'LV global longitudinal strain and global circumferential strain', 'left ventricular systolic function (LVSF', 'changes in diastolic and/or in systolic longitudinal function as measured by tissue Doppler']","[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0449829', 'cui_str': 'Geometry (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0033144', 'cui_str': 'Disease Prevention, Primary'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C3153993', 'cui_str': 'Linagliptin 5 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl-Peptidase IV'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0242698', 'cui_str': 'Ventricular Dysfunction, Left'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0449829', 'cui_str': 'Geometry (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]",188.0,0.559868,"As an exploratory analysis, significant changes in LV global longitudinal strain and global circumferential strain, measured by speckle tracking echocardiography, were also considered.","[{'ForeName': 'Carlo Bruno', 'Initials': 'CB', 'LastName': 'Giorda', 'Affiliation': 'Metabolism and Diabetes Unit, ASL TORINO 5, Regione Piemonte, Chieri, Italy. carlogiordaposta@gmail.com.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cioffi', 'Affiliation': 'Division of Rheumatology, Department of Medicine, University and Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.'}, {'ForeName': 'Donata', 'Initials': 'D', 'LastName': 'Lucci', 'Affiliation': 'ANMCO Research Center, Heart Care Foundation, Florence, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Nada', 'Affiliation': 'Metabolism and Diabetes Unit, ASL TORINO 5, Regione Piemonte, Chieri, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Ognibeni', 'Affiliation': 'Division of Rheumatology, Department of Medicine, University and Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.'}, {'ForeName': 'Costantino', 'Initials': 'C', 'LastName': 'Mancusi', 'Affiliation': 'Hypertension Research Center, Federico II University, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Latini', 'Affiliation': 'Department of Cardiovascular Research, Istituto di Ricerche Farmacologiche ""Mario Negri"" IRCCS, Milan, Italy.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Heart Care Foundation, Florence, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular drugs and therapy,['10.1007/s10557-019-06898-6']
3176,31046521,"Sildenafil enhances central hemodynamic responses to exercise, but not V̇o 2peak , in people with diabetes mellitus.","Exercise capacity is frequently reduced in people with diabetes mellitus (DM), and the contribution of pulmonary microvascular dysfunction remains undefined. We hypothesized that pulmonary microvascular disease, measured by a novel exercise echocardiography technique termed pulmonary transit of agitated contrast (PTAC), would be greater in subjects with DM and that the use of pulmonary vasodilator agent sildenafil would improve exercise performance by reducing right ventricular afterload. Forty subjects with DM and 20 matched controls performed cardiopulmonary exercise testing and semisupine exercise echocardiography 1 h after placebo or sildenafil ingestion in a double-blind randomized crossover design. The primary efficacy end point was exercise capacity (V̇o 2peak ) while secondary measures included pulmonary vascular resistance, cardiac output, and change in PTAC. DM subjects were aged 44 ± 13 yr, 73% male, with 16 ± 10 yr DM history. Sildenafil caused marginal improvements in echocardiographic measures of biventricular systolic function in DM subjects. Exercise-induced increases in pulmonary artery systolic pressure and pulmonary vascular resistance were attenuated with sildenafil, while heart rate (+2.4 ±1.2 beats/min,  P  = 0.04) and cardiac output (+322 ± 21 ml,  P  = 0.03) improved. However, the degree of PTAC did not change ( P  = 0.93) and V̇o 2peak  did not increase following sildenafil as compared with placebo (V̇o 2peak : 31.8 ± 9.7 vs. 32.1 ± 9.5 ml·min -1 ·kg -1 ,  P  = 0.42). We conclude that sildenafil administration causes modest acute improvements in central hemodynamics but does not improve exercise capacity. This may be due to the mismatch in action of sildenafil on the pulmonary arteries rather than the distal pulmonary microvasculature and potential adverse effects on peripheral oxygen extraction.  NEW & NOTEWORTHY  This is one of the largest and most comprehensive studies of cardiopulmonary exercise performance in people with diabetes mellitus and to our knowledge the first to assess the effect of sildenafil using detailed echocardiographic measures during incremental exercise. Sildenafil attenuated the rise in pulmonary vascular resistance while augmenting cardiac output and intriguingly heart rate, without conferring any improvement in exercise capacity. The enhanced central hemodynamic indexes may have been offset by reduced peripheral O 2  extraction.",2019,"Exercise-induced increases in pulmonary artery systolic pressure and pulmonary vascular resistance were attenuated with sildenafil, while heart rate (+2.4 ±1.2 beats/min,  P  = 0.04) and cardiac output (+322 ± 21 ml,  P  = 0.03) improved.","['DM subjects were aged 44\u2009±\u200913 yr, 73% male, with 16\u2009±\u200910 yr DM history', 'Forty subjects with DM and 20 matched controls performed', 'people with diabetes mellitus (DM', 'DM subjects', 'people with diabetes mellitus']","['placebo', 'Sildenafil', 'sildenafil', 'cardiopulmonary exercise performance', 'cardiopulmonary exercise testing and semisupine exercise echocardiography 1 h after placebo or sildenafil ingestion']","['cardiac output', 'heart rate', 'exercise performance', 'echocardiographic measures of biventricular systolic function', 'pulmonary artery systolic pressure and pulmonary vascular resistance', 'pulmonary vascular resistance', 'exercise capacity', 'pulmonary vascular resistance, cardiac output, and change in PTAC', 'Exercise capacity', 'exercise capacity (V̇o 2peak ']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure (observable entity)'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0760635', 'cui_str': 'PTAC'}]",40.0,0.431972,"Exercise-induced increases in pulmonary artery systolic pressure and pulmonary vascular resistance were attenuated with sildenafil, while heart rate (+2.4 ±1.2 beats/min,  P  = 0.04) and cardiac output (+322 ± 21 ml,  P  = 0.03) improved.","[{'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Roberts', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Burns', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': ""St. Vincent's Department of Medicine, University of Melbourne , Fitzroy , Australia.""}, {'ForeName': 'Andrew I', 'Initials': 'AI', 'LastName': 'MacIsaac', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Prior', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'La Gerche', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00947.2018']
3177,31811206,An abluminal biodegradable polymer sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients undergoing coronary revascularization: 3-year clinical outcomes of a randomized non-inferiority trial.,"The Cordimax stent has proved non-inferior to the Cypher Select durable polymer sirolimus-eluting stent for the primary endpoint of angiographic in-stent late luminal loss and in-stent mean diameter stenosis at 9 months. The trial was designed to compare the efficacy and safety of the Cordimax stent with the Xience V stent in patients undergoing coronary revascularization. This randomized, multicenter trial enrolled 3697 patients treated with Cordimax stent (2460 patients) and Xience V stent (1237 patients). The primary efficacy endpoint was a target-lesion failure (TLF) at 1 year and the primary safety endpoint was a composite of death or myocardial infarction (MI) at 3 years. 3399 patients (91.9%) completed 3-year follow-up. At 1 year, the primary efficacy endpoint occurred in 86 (3.5%) patients in the Cordimax group versus 40 (3.2%) patients in the Xience V group (0.3% absolute risk difference, 95% CI -1.0-1.5%, P non-inferiority  < 0.0001). At 3 years, the primary safety endpoint occurred in 39 (1.6%) patients in the Cordimax group versus 19 (1.5%) patients in the Xience V group (0.05% absolute risk difference, 95% CI -0.8-0.9%, P non-inferiority  < 0.0001). The incidence of target lesion revascularization was low in Cordimax group compared with Xience V group (3.6% versus 5.1%, P = 0.03). There were no differences between Cordimax and Xience V in terms of Cardiac death (0.3% versus 0.4%, P = 0.70), myocardial infarction (1.2% versus 0.9%, P = 0.37), and the stent thrombosis (0.4% versus 0.6%, P = 0.61). In conclusion, safety and efficacy outcomes of Cordimax stent were non-inferior to the Xience V stent 3 years after stent implantation.",2019,"At 1 year, the primary efficacy endpoint occurred in 86 (3.5%) patients in the Cordimax group versus 40 (3.2%) patients in the Xience V group (0.3% absolute risk difference, 95% CI -1.0-1.5%, P non-inferiority  < 0.0001).","['3697 patients treated with', 'patients undergoing coronary revascularization', '2460 patients) and Xience V stent (1237 patients', '3399 patients (91.9%) completed 3-year follow-up']","['sirolimus-eluting stent versus a durable polymer everolimus-eluting stent', 'Cordimax stent with the Xience V stent', 'Cordimax stent']","['incidence of target lesion revascularization', 'composite of death or myocardial infarction (MI', 'Cardiac death', 'myocardial infarction', 'stent thrombosis', 'target-lesion failure (TLF', 'efficacy and safety', 'safety and efficacy outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",3697.0,0.170815,"At 1 year, the primary efficacy endpoint occurred in 86 (3.5%) patients in the Cordimax group versus 40 (3.2%) patients in the Xience V group (0.3% absolute risk difference, 95% CI -1.0-1.5%, P non-inferiority  < 0.0001).","[{'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Intervention & Vascular Surgery, Medical College of Tongji University, Shanghai, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Intervention & Vascular Surgery, Medical College of Tongji University, Shanghai, China. zxpkxy@tongji.edu.cn.'}, {'ForeName': 'Yuxia', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Key Laboratory of Public Health Safety, Ministry of Education, School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Junwei', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Hou', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Shoutao', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Xiaoshan', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Shenguo', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Institute of Chemistry, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Institute of Chemistry, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Cuihai', 'Initials': 'C', 'LastName': 'Duan', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China. ge.junbo@zs-hospital.sh.cn.'}]",Scientific reports,['10.1038/s41598-019-54964-8']
3178,32138596,Lower-body compression garments worn following exercise improves perceived recovery but not subsequent performance in basketball athletes.,"This study examined the effects of lower-body compression garments on perceived recovery and subsequent performance in basketball athletes. In a parallel-group design, 30 recreational, male basketball athletes were randomly allocated to either a control (CON, n = 15, loose-fitting clothing) or experimental group (COMP, n = 15, compression garments) for 15 h following fatigue-inducing, basketball-specific exercise in the evening (1600-1800 h). Perceptual measures of fatigue and muscle soreness, as well as physical performance tests (sprints, jumps and agility), were performed pre-exercise, post-exercise, and post-recovery (15 h following exercise). Subjective and objective measures of sleep were recorded following the exercise trial. There were non-significant ( p  > 0.05),  unclear-trivial  differences between groups for all performance measures. Perceived post-recovery fatigue ( d =  -1.27,  large ) and muscle soreness ( d = -1 .61,  large ) were significantly lower in COMP compared to CON ( p  < 0.05). COMP exhibited better perceived sleep quality ( d  = 0.42,  small, p  = 0.18) than CON, with an  unclear  difference in sleep duration between groups ( p  > 0.05). Wearing lower-body compression garments overnight improved perceived fatigue and muscle soreness, but had negligible effects on subsequent physical performance in basketball athletes. Future research should focus on longer periods of compression wear following fatiguing exercise.",2020,"COMP exhibited better perceived sleep quality ( d  = 0.42,  small, p  = 0.18) than CON, with an  unclear  difference in sleep duration between groups ( p  > 0.05).","['30 recreational, male basketball athletes', 'basketball athletes']","['lower-body compression garments', 'control (CON, n =\xa015, loose-fitting clothing) or experimental group (COMP, n =\xa015, compression garments) for 15\xa0h following fatigue-inducing, basketball-specific exercise', 'CON', 'COMP']","['sleep duration', 'fatigue and muscle soreness', 'Subjective and objective measures of sleep', 'Perceptual measures of fatigue and muscle soreness, as well as physical performance tests (sprints, jumps and agility', 'muscle soreness ', 'subsequent physical performance', 'sleep quality']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C2985539', 'cui_str': 'Compression garment (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205407', 'cui_str': 'Loose (qualifier value)'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2607857'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0494114,"COMP exhibited better perceived sleep quality ( d  = 0.42,  small, p  = 0.18) than CON, with an  unclear  difference in sleep duration between groups ( p  > 0.05).","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Atkins', 'Affiliation': 'Health, Sport and Human Performance, University of Waikato, Hamilton, New Zealand.'}, {'ForeName': 'Wing-Kai', 'Initials': 'WK', 'LastName': 'Lam', 'Affiliation': 'Li Ning Sports Science Research Center, Beijing, China.'}, {'ForeName': 'Aaron T', 'Initials': 'AT', 'LastName': 'Scanlan', 'Affiliation': 'Human Exercise and Training Laboratory, School of Health, Medical, and Applied Sciences, Central Queensland University, Rockhampton, Australia.'}, {'ForeName': 'C Martyn', 'Initials': 'CM', 'LastName': 'Beaven', 'Affiliation': 'Health, Sport and Human Performance, University of Waikato, Hamilton, New Zealand.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Driller', 'Affiliation': 'Health, Sport and Human Performance, University of Waikato, Hamilton, New Zealand.'}]",Journal of sports sciences,['10.1080/02640414.2020.1737387']
3179,32249034,Health literacy and education level correlates of participation and outcome in a remotely delivered epilepsy self-management program.,"SIGNIFICANCE


Health literacy, the ability to understand necessary health information to make proper health decisions, has been linked to greater frequency of hospitalizations. However, there is limited literature on the associations between health literacy and outcomes in patients with epilepsy, and thus, this secondary analysis investigates the associations between health literacy and outcomes in patients with epilepsy enrolled in the self-management intervention ""Self-management for people with epilepsy and a history of negative events"" (SMART). We examined the associations between higher health literacy and higher education level and outcomes of the SMART trial.
METHODS


This is a secondary analysis of data from the SMART self-management intervention, where individuals were randomized to the SMART intervention or a 6-month waitlist (WL) control. Health literacy was assessed at baseline before randomization using the Rapid Estimate of Adult Literacy in Medicine (REALM-R). Education level was self-reported by participants at baseline. Pearson correlations between REALM-R scores and continuous demographic and clinical variables were conducted. Point-biserial Pearson correlations were computed for REALM-R and dichotomous variables. The effect of education on change in negative health events (NHEs) counts from baseline to six months was conducted using a linear regression. A logistic regression with health literacy and randomization arm as predictors and improvement in NHE (1 = improvement, 0 = no change or increased NHEs at 6 months) as the outcome was conducted.
RESULTS


Lower education and lower income were significantly correlated with lower health literacy (p < 0.001 and p = 0.03). Higher education level was associated with a greater improvement in 6-month seizure counts (r s (105) = 0.29, p = 0.002), and a greater improvement in total 6-month NHEs (r s (95) = 0.20, p = 0.045). Health literacy was not associated with change in NHEs or with study retention.
CONCLUSIONS


The SMART intervention appears effective for individuals regardless of health literacy competency. Nevertheless, individuals with higher levels of education have fewer epilepsy complications, and thus, those with limited education may still require additional support while participating in epilepsy self-management programs.",2020,"Higher education level was associated with a greater improvement in 6-month seizure counts (r s (105) = 0.29, p = 0.002), and a greater improvement in total 6-month NHEs (r s (95) = 0.20, p = 0.045).","['patients with epilepsy enrolled in the self-management intervention ""Self-management for people with epilepsy and a history of negative events"" (SMART', 'patients with epilepsy']",['SMART intervention'],"['total 6-month NHEs', 'Health literacy', 'lower health literacy', '6-month seizure counts', 'negative health events (NHEs) counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0074785', 'cui_str': 'Sodium-Hydrogen Antiporter'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0431183,"Higher education level was associated with a greater improvement in 6-month seizure counts (r s (105) = 0.29, p = 0.002), and a greater improvement in total 6-month NHEs (r s (95) = 0.20, p = 0.045).","[{'ForeName': 'Shwetha', 'Initials': 'S', 'LastName': 'Sudhakar', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, OH, USA. Electronic address: sxs1963@case.edu.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Aebi', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Burant', 'Affiliation': 'Case Western Reserve University School of Nursing, Louis Stokes Cleveland VAMC, Cleveland, OH, USA.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Wilson', 'Affiliation': 'Department of Neurology, Neurological & Behavioral Outcomes Center, Case Western Reserve University School of Medicine Cleveland, OH, USA.'}, {'ForeName': 'Jocasta', 'Initials': 'J', 'LastName': 'Wenk', 'Affiliation': 'Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Farren B S', 'Initials': 'FBS', 'LastName': 'Briggs', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Nataliya', 'Initials': 'N', 'LastName': 'Pyatka', 'Affiliation': 'Department of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Blixen', 'Affiliation': 'Department of Psychiatry and Neurological and Behavioral Outcomes, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'Department of Neurology, Neurological & Behavioral Outcomes Center, Case Western Reserve University School of Medicine Cleveland, OH, USA; Department of Psychiatry, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107026']
3180,23795857,Methodological development of an exploratory randomised controlled trial of an early years' nutrition intervention: the CHERRY programme (Choosing Healthy Eating when Really Young).,"Good nutrition in the early years of life is vitally important for a child's development, growth and health. Children's diets in the United Kingdom are known to be poor, particularly among socially disadvantaged groups, and there is a need for timely and appropriate interventions that support parents to improve the diets of young children. The Medical Research Council has highlighted the importance of conducting developmental and exploratory research prior to undertaking full-scale trials to evaluate complex interventions, but have provided very limited detailed guidance on the conduct of these initial phases of research. This paper describes the initial developmental stage and the conduct of an exploratory randomised controlled trial undertaken to determine the feasibility and acceptability of a family-centred early years' nutrition intervention. Choosing Healthy Eating when Really Young (CHERRY) is a programme for families with children aged 18 months to 5 years, delivered in children's centres in one urban (Islington) and one rural (Cornwall) location in the United Kingdom. In the development stage, a mixed-methods approach was used to investigate the nature of the problem and options for support. A detailed review of the evidence informed the theoretical basis of the study and the creation of a logic model. In the feasibility and pilot testing stage of the exploratory trial, 16 children's centres, with a sample of 394 families were recruited onto the study. We hope that the methodology, which we present in this paper, will inform and assist other researchers in conducting community-based, exploratory nutrition research in early years settings.",2014,"Choosing Healthy Eating when Really Young (CHERRY) is a programme for families with children aged 18 months to 5 years, delivered in children's centres in one urban (Islington) and one rural (Cornwall) location in the United Kingdom.","['Choosing Healthy Eating when Really Young', ""16 children's centres, with a sample of 394 families were recruited onto the study"", ""families with children aged 18 months to 5 years, delivered in children's centres in one urban (Islington) and one rural (Cornwall) location in the United Kingdom""]","[""family-centred early years' nutrition intervention"", 'CHERRY programme']",[],"[{'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0330657', 'cui_str': 'Pie Cherry'}]",[],16.0,0.0468934,"Choosing Healthy Eating when Really Young (CHERRY) is a programme for families with children aged 18 months to 5 years, delivered in children's centres in one urban (Islington) and one rural (Cornwall) location in the United Kingdom.","[{'ForeName': 'Richard Geddie', 'Initials': 'RG', 'LastName': 'Watt', 'Affiliation': 'Department of Epidemiology and Public Health, University College London, London, UK.'}, {'ForeName': 'Alizon K', 'Initials': 'AK', 'LastName': 'Draper', 'Affiliation': ''}, {'ForeName': 'Heather R', 'Initials': 'HR', 'LastName': 'Ohly', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Rees', 'Affiliation': ''}, {'ForeName': 'Hynek', 'Initials': 'H', 'LastName': 'Pikhart', 'Affiliation': ''}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Cooke', 'Affiliation': ''}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Crawley', 'Affiliation': ''}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Pettinger', 'Affiliation': ''}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'McGlone', 'Affiliation': ''}, {'ForeName': 'Arabella K M', 'Initials': 'AK', 'LastName': 'Hayter', 'Affiliation': ''}]",Maternal & child nutrition,['10.1111/mcn.12061']
3181,32245747,Erratum. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care 2020;43:607-615.,,2020,,[],['Mobile Closed-Loop Control'],[],[],"[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.138398,,"[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Kovatchev', 'Affiliation': ''}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Raghinaru', 'Affiliation': ''}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': ''}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': ''}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': ''}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': ''}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': ''}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Buckingham', 'Affiliation': ''}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Doyle', 'Affiliation': ''}, {'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Mei Mei', 'Initials': 'MM', 'LastName': 'Church', 'Affiliation': ''}, {'ForeName': 'Vikash', 'Initials': 'V', 'LastName': 'Dadlani', 'Affiliation': ''}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Dassau', 'Affiliation': ''}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': ''}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': ''}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Isganaitis', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Lam', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lum', 'Affiliation': ''}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-er06']
3182,25382710,Association of maternal depression and infant nutritional status among women living with HIV in Tanzania.,"Antenatal and post-natal depression has demonstrated a significant burden in sub-Saharan Africa, with rates ranging from 10% to 35%. However, perinatal women living with HIV in Tanzania have reported an even greater prevalence of depression (43-45%). The primary goal of this study was to examine the relationship between maternal depression and infant malnutrition among women living with HIV. The design was a retrospective cohort study within the context of a randomised controlled trial among women living with HIV and their infants. Within this trial, 699 mother-child pairs were analysed for the present study. Although antenatal depression was not associated with infant malnutrition and post-natal depression was negatively associated [relative risk (RR = 0.80, P = 0.04], cumulative depression demonstrated a positive association with infant wasting (RR = 1.08, P < 0.01) and underweight (RR = 1.03, P < 0.01) after controlling for confounding factors. Variation in the association between depression and infant nutritional status was observed for episodic vs. chronic depression. These findings suggest that providing evidence-based services for persistent depression among women living with HIV may have an effect on infant malnutrition. In addition, other positive outcomes may be related to infant cognitive development as well as HIV disease prognosis and survival among women.",2016,"Although antenatal depression was not associated with infant malnutrition and post-natal depression was negatively associated [relative risk (RR = 0.80, P = 0.04], cumulative depression demonstrated a positive association with infant wasting (RR = 1.08, P < 0.01) and underweight (RR = 1.03, P < 0.01) after controlling for confounding factors.","['women living with HIV in Tanzania', '699 mother-child pairs', 'women living with HIV and their infants', 'women living with HIV', 'perinatal women living with HIV in Tanzania']",[],"['cumulative depression', 'maternal depression and infant malnutrition', 'maternal depression and infant nutritional status']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1257752', 'cui_str': 'Infant Malnutrition'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}]",699.0,0.241237,"Although antenatal depression was not associated with infant malnutrition and post-natal depression was negatively associated [relative risk (RR = 0.80, P = 0.04], cumulative depression demonstrated a positive association with infant wasting (RR = 1.08, P < 0.01) and underweight (RR = 1.03, P < 0.01) after controlling for confounding factors.","[{'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Kaaya', 'Affiliation': 'School of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Garcia', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Global Health and Population, Harvard School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Lienert', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Twayigize', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Smith Fawzi', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12154']
3183,32193166,Add a comment … how fitspiration and body positive captions attached to social media images influence the mood and body esteem of young female Instagram users.,"Social media content can negatively influence body esteem in young women by reinforcing beliefs that to be considered attractive, people must look a certain way. The current study examines how text associated with attractive social media images impacts on female users' mood and feelings about their own body. Female participants (N = 109) aged between 18 and 25 years were randomly allocated to one of three conditions in which they viewed the same fitspiration-style images from Instagram. However, the captions associated with each image were experimentally manipulated to reflect either a fitspiration, body positive, or neutral theme. Images associated with fitspiration captions encouraging observers to improve their personal fitness led to increased negative mood. When body-positive captions encouraging the self-acceptance of appearance or highlighting the unrealistic nature of social media content were viewed with the same images, no increase in negative affect was observed, and participants reported greater body esteem post exposure. The findings provide partial support for the idea that body positive comments accompanying images on Instagram may have some protective value for female body esteem. Captions may play an important part in observers' reactions to social media images, beyond the influence of the images alone.",2020,"Captions may play an important part in observers' reactions to social media images, beyond the influence of the images alone.","['Female participants (N = 109) aged between 18 and 25 years', 'young female Instagram users', ""female users' mood and feelings about their own body"", 'young women']",[],"['body esteem', 'mood and body esteem']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0026516', 'cui_str': 'Mood'}]",109.0,0.0163805,"Captions may play an important part in observers' reactions to social media images, beyond the influence of the images alone.","[{'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Davies', 'Affiliation': 'Department of Psychology, King Henry Building, University of Portsmouth, Portsmouth, PO1 2DY. United Kingdom. Electronic address: Bryony.Davies@port.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Turner', 'Affiliation': 'Department of Psychology, King Henry Building, University of Portsmouth, Portsmouth, PO1 2DY. United Kingdom. Electronic address: Mark.Turner@port.ac.uk.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Udell', 'Affiliation': 'Department of Psychology, King Henry Building, University of Portsmouth, Portsmouth, PO1 2DY. United Kingdom. Electronic address: Julie.Udell@port.ac.uk.'}]",Body image,['10.1016/j.bodyim.2020.02.009']
3184,32045676,Predictors of Intervention Session Completion in a Randomized Clinical Trial of a Behavioral Cancer Pain Intervention.,"CONTEXT


Some patients with cancer are able to complete psychosocial pain management intervention sessions, and others find it difficult to do so.
OBJECTIVES


Conduct a secondary analysis of a randomized clinical trial (N = 178) that compared delivery formats (in-person vs. videoconference) of a pain coping skills training (PCST) intervention for patients with cancer to examine if intervention session completion predicts postintervention outcomes of pain severity and interference, psychological distress, physical well-being, and pain self-efficacy; and identify predictors (i.e., demographics, medical characteristics, baseline outcome scores) of session completion.
METHODS


Session completion (i.e., completing all four sessions vs. missing at least one session) was tested as a predictor of postintervention outcomes. Predictors of session completion were then examined.
RESULTS


In both study conditions combined, PCST session completion predicted improvement from baseline to postintervention in pain severity (β = -0.27; P = 0.03), pain interference (β = -0.25; P = 0.048), and pain self-efficacy (β = 0.23; P = 0.07). Participants in the videoconference condition were significantly more likely than those in the in-person condition to complete all sessions (83% vs. 65%; P = 0.006). Participants with at least some college education (odds ratio [OR] 4.36; P = 0.04), a diagnosis of breast cancer (OR 6.73; P = 0.04), and higher levels of pain self-efficacy (OR 2.32; P = 0.02) were more likely to complete videoconference sessions. Participants who lived closer to the medical center (OR 0.64; P = 0.07), had early stage cancer (OR 3.82; P = 0.07), and fewer medical comorbidities (OR 0.59; P = 0.04) were more likely to complete in-person sessions.
CONCLUSION


Completing PCST sessions is important for improving pain outcomes. Efforts to increase session completion (e.g., videoconference delivery) should be considered.",2020,"Participants in the videoconference condition were significantly more likely than those in the in-person condition to complete all sessions (83% vs. 65%, p=0.006).","['patients with cancer', 'patients with cancer to']","['Behavioral Cancer Pain Intervention', 'Pain Coping Skills Training (PCST) intervention']","['pain self-efficacy', 'pain severity', 'medical comorbidities', 'pain severity and interference, psychological distress, physical well-being, and pain self-efficacy', 'diagnosis of breast cancer', 'pain outcomes', 'early stage cancer', 'pain interference']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",178.0,0.0630955,"Participants in the videoconference condition were significantly more likely than those in the in-person condition to complete all sessions (83% vs. 65%, p=0.006).","[{'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Winger', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA. Electronic address: joseph.winger@duke.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Nunez', 'Affiliation': 'Miller School of Medicine, University of Miami, Coral Gables, Florida, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Kelleher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Krista K', 'Initials': 'KK', 'LastName': 'Ingle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Gandhi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Somers', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.01.020']
3185,30585388,Effect of early tirofiban administration on N-terminal pro-B-type natriuretic peptide level in patients treated with primary percutaneous coronary intervention.,"OBJECTIVES


To investigate the potential association between early tirofiban treatment and N-terminal pro-B-type natriuretic peptide (NT-proBNP) level after primary percutaneous coronary intervention (PCI).
BACKGROUND


Whether the use of adjunctive early glycoprotein IIb/IIIa inhibitors (GPIs) therapy, may affect the level of NT-proBNP after primary PCI is poorly studied.
METHODS


Nine hundred and eighty four ST-elevation myocardial infarction (STEMI) patients undergoing primary PCI were randomized to either pre-hospital tirofiban administration or placebo. NT-proBNP levels were evaluated on admission before angiography (baseline) and 18-96 hr after PCI.
RESULTS


There were 918 (93.3%) patients with NT-proBNP values available at baseline and 865 (87.9%) post-PCI. Post-PCI NT-proBNP level dichotomized with median value as cut-off (968.8 pg/mL, IQR 430.9-1970.0) was significantly lower in patients treated with early tirofiban as compared to placebo (45.5% vs. 54.2% P = 0.011). At multivariate logistic regression analysis, independent predictors of post-PCI NT-proBNP level above the median were: NT-proBNP baseline level (OR 5.19; 95% CI, 2.92-9.25, P < 0.001), Killip class>I (OR 4.07; 95% CI 1.24-13.36, P = 0.021), anterior infarct location (OR 2.61; 95% CI 1.84-3.70, P < 0.001), age (years) (OR 1.04; 95% CI 1.03-1.06, P < 0.001), male gender (OR 0.38; 95% CI 0.26-0.57, P < 0.001), prior PCI (OR 0.49; 95% CI 0.27-0.90, P = 0.021) and tirofiban administration (OR 0.71; 95% CI 0.51-0.99; P = 0.045).
CONCLUSIONS


In a large cohort of STEMI patients, pre-hospital tirofiban administration was independently associate with a lower risk of high NT-proBNP level after primary PCI, supporting the potential benefit of early antithrombotic treatment administration in STEMI patients. The trial is registered under No. ISRCTN06195297.",2019,"I (OR 4.07; 95% CI 1.24-13.36, P = 0.021), anterior infarct location (OR 2.61; 95% CI 1.84-3.70, P < 0.001), age (years) (OR 1.04; 95% CI 1.03-1.06, P < 0.001), male gender (OR 0.38; 95% CI 0.26-0.57, P < 0.001), prior PCI (OR 0.49; 95% CI 0.27-0.90, P = 0.021) and tirofiban administration (OR 0.71; 95% CI 0.51-0.99; P = 0.045).
","['Nine hundred and eighty four ST-elevation myocardial infarction (STEMI) patients undergoing primary PCI', 'patients treated with primary percutaneous coronary intervention']","['placebo', 'pre-hospital tirofiban administration or placebo', 'tirofiban', 'tirofiban treatment and N-terminal pro-B-type natriuretic peptide (NT-proBNP', 'adjunctive early glycoprotein IIb/IIIa inhibitors (GPIs) therapy']","['anterior infarct location', 'Killip class', 'NT-proBNP levels']","[{'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.528918,"I (OR 4.07; 95% CI 1.24-13.36, P = 0.021), anterior infarct location (OR 2.61; 95% CI 1.84-3.70, P < 0.001), age (years) (OR 1.04; 95% CI 1.03-1.06, P < 0.001), male gender (OR 0.38; 95% CI 0.26-0.57, P < 0.001), prior PCI (OR 0.49; 95% CI 0.27-0.90, P = 0.021) and tirofiban administration (OR 0.71; 95% CI 0.51-0.99; P = 0.045).
","[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Fabris', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, The Netherlands.'}, {'ForeName': 'Jan Paul', 'Initials': 'JP', 'LastName': 'Ottervanger', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, The Netherlands.'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, The Netherlands.'}, {'ForeName': 'Jurrien M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Sinagra', 'Affiliation': 'Cardiovascular Department, University of Trieste, Trieste, Italy.'}, {'ForeName': 'Petra C', 'Initials': 'PC', 'LastName': 'Koopmans', 'Affiliation': 'Diagram CRO, Zwolle, The Netherlands.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Giannitsis', 'Affiliation': 'Department of Cardiology, Universitats Klinik, Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Department of Cardiology, Kerckhoff Klinik, Bad Nauheim, Germany.'}, {'ForeName': 'Arnoud W J', 'Initials': 'AWJ', 'LastName': ""van 't Hof"", 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, The Netherlands.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28043']
3186,30265429,Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study.,"BACKGROUND


In the randomized AMIHOT-II trial, supersaturated oxygen [SSO 2  ] delivered into the left anterior descending (LAD) artery via an indwelling intracoronary infusion catheter following primary percutaneous coronary intervention (PCI) significantly reduced infarct size in patients with anterior ST-segment elevation myocardial infarction (STEMI) but resulted in a numerically higher incidence of safety events.
OBJECTIVES


The IC-HOT study evaluated the safety of SSO 2  therapy selectively delivered to the left main coronary artery (LMCA) for 60 minutes after PCI in patients with anterior STEMI.
METHODS


SSO 2  therapy was administered to the LMCA after stent implantation in 100 patients with anterior STEMI and proximal or mid-LAD occlusion presenting within 6 hours of symptom onset. The primary endpoint was the 30-day composite rate of net adverse clinical events (NACE) (death, reinfarction, clinically driven target vessel revascularization, stent thrombosis, severe heart failure, or TIMI major/minor bleeding) compared against an objective performance goal of 10.7%. Cardiac magnetic resonance imaging was performed at 4 and 30 days to assess infarct size.
RESULTS


SSO 2  delivery was successful in 98% of patients. NACE at 30 days occurred 7.1% of patients (meeting the primary safety endpoint of the study); there were no deaths, only one stent thrombosis and one case of severe heart failure. Median [interquartile range] infarct size was 24.1% [14.4%, 31.6%] at 4 days and 19.4% [8.8%, 28.9%] at 30 days.
CONCLUSION


Following primary PCI in acute anterior STEMI, infusion of SSO 2  via the LMCA was feasible and was associated with a favorable early safety profile.",2019,"Following primary PCI in acute anterior STEMI, infusion of SSO 2  via the LMCA was feasible and was associated with a favorable early safety profile.","['100 patients with anterior STEMI and proximal or mid-LAD occlusion presenting within 6\u2009hours of symptom onset', 'acute anterior myocardial infarction', 'patients with anterior ST-segment elevation myocardial infarction (STEMI']","['NACE', 'intracoronary hyperoxemic oxygen therapy', 'LMCA', 'Cardiac magnetic resonance imaging']","['stent thrombosis and one case of severe heart failure', 'Median [interquartile range] infarct size', '30-day composite rate of net adverse clinical events (NACE) (death, reinfarction, clinically driven target vessel revascularization, stent thrombosis, severe heart failure, or TIMI major/minor bleeding']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2349195', 'cui_str': 'Acute Anterior Wall Myocardial Infarction'}, {'cui': 'C3874460', 'cui_str': 'Anterior ST segment elevation'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}]",100.0,0.271789,"Following primary PCI in acute anterior STEMI, infusion of SSO 2  via the LMCA was feasible and was associated with a favorable early safety profile.","[{'ForeName': 'Shukri W', 'Initials': 'SW', 'LastName': 'David', 'Affiliation': 'Providence-Providence Park Hospital, Southfield, Michigan.'}, {'ForeName': 'Zubair A', 'Initials': 'ZA', 'LastName': 'Khan', 'Affiliation': 'Providence-Providence Park Hospital, Southfield, Michigan.'}, {'ForeName': 'Nainesh C', 'Initials': 'NC', 'LastName': 'Patel', 'Affiliation': 'Lehigh Valley Hospital, Allentown, Pennsylvania.'}, {'ForeName': 'D Christopher', 'Initials': 'DC', 'LastName': 'Metzger', 'Affiliation': 'Wellmont CVA Heart Institute, Kingsport, Tennessee.'}, {'ForeName': 'Frances O', 'Initials': 'FO', 'LastName': 'Wood', 'Affiliation': 'WakeMed Hospital, Raleigh, North Carolina.'}, {'ForeName': 'Hal S', 'Initials': 'HS', 'LastName': 'Wasserman', 'Affiliation': 'Danbury Hospital, Danbury, Connecticut.'}, {'ForeName': 'Amir S', 'Initials': 'AS', 'LastName': 'Lotfi', 'Affiliation': 'Baystate Medical Center, Springfield, Massachusetts.'}, {'ForeName': 'Ivan D', 'Initials': 'ID', 'LastName': 'Hanson', 'Affiliation': 'Beaumont Health System, Royal Oak, Michigan.'}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Dixon', 'Affiliation': 'St John Hospital and Medical Center, Detroit, Michigan.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'LaLonde', 'Affiliation': 'St John Hospital and Medical Center, Detroit, Michigan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Généreux', 'Affiliation': 'Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey.'}, {'ForeName': 'Melek Ozgu', 'Initials': 'MO', 'LastName': 'Ozan', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.27905']
3187,32255568,Psychological and physiological impacts of a fast-track diagnostic workup for men with suspected prostate cancer: Preliminary report from a randomized clinical trial.,,2020,,['men with suspected prostate cancer'],['fast-track diagnostic workup'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1277615', 'cui_str': 'Suspected prostate cancer'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",[],,0.0407896,,"[{'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Orthopedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan, 610000, P. R. China.'}, {'ForeName': 'Ruoqing', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, 171 77, Sweden.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Davidsson', 'Affiliation': 'Department of Urology, Faculty of Medicine and Health, Örebro University, Örebro, 701 85, Sweden.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Carlsson', 'Affiliation': 'Department of Urology, Faculty of Medicine and Health, Örebro University, Örebro, 701 85, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Messing-Eriksson', 'Affiliation': 'Department of Urology, Faculty of Medicine and Health, Örebro University, Örebro, 701 85, Sweden.'}, {'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Fridfeldt', 'Affiliation': 'Department of Urology, Faculty of Medicine and Health, Örebro University, Örebro, 701 85, Sweden.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andrén', 'Affiliation': 'Department of Urology, Faculty of Medicine and Health, Örebro University, Örebro, 701 85, Sweden.'}, {'ForeName': 'Sven-Olof', 'Initials': 'SO', 'LastName': 'Andersson', 'Affiliation': 'Department of Urology, Faculty of Medicine and Health, Örebro University, Örebro, 701 85, Sweden.'}, {'ForeName': 'Unnur', 'Initials': 'U', 'LastName': 'Valdimarsdóttir', 'Affiliation': 'Department of Orthopedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan, 610000, P. R. China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'Institute of Environmental Medicine, Karolinska Institutet, Stockholm, 171 77, Sweden.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Fall', 'Affiliation': 'Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, Örebro, 701 85, Sweden.'}]","Cancer communications (London, England)",['10.1002/cac2.12021']
3188,32179181,Efficacy of strategies to increase participation in cervical cancer screening: GPs offering self-sampling kits for HPV testing versus recommendations to have a pap smear taken - A randomised controlled trial.,,2020,,['cervical cancer screening'],[],[],"[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",[],[],,0.0359161,,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Peeters', 'Affiliation': 'Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Cornet', 'Affiliation': 'De Groet, General Practice Oetingen, Gooik, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Devroey', 'Affiliation': 'General Medicine, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arbyn', 'Affiliation': 'Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium. Electronic address: marc.arbyn@sciensano.be.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100194']
3189,26990672,Breastfeeding booklet and proactive phone calls for increasing exclusive breastfeeding rates: RCT protocol.,"Breastfeeding is associated with infant and maternal health benefits and considerable potential savings to health services. Despite this, only 37% of infants globally are exclusively breastfed for 6 months. Interventions are needed to improve breastfeeding rates. The aim of this study is to determine whether written breastfeeding information in pregnancy and proactive breastfeeding-focused support phone calls, provided by a health professional educated in breastfeeding management, increase exclusive breastfeeding rates at 3 months compared with general birth-related information with proactive support calls or standard care. This is a single-centre, randomised, controlled, three-arm, superiority study with blind outcome assessment. Eligible participants will include primigravidae with singleton pregnancies who speak Croatian, attending six primary care obstetric practices. We estimate a total sample size of 459, with computer generated stratified randomisation of 153 women per arm. Participants in the intervention and active control groups will receive booklets in pregnancy, phone calls 2 weeks later, and 2, 6 and 10 weeks after birth. The primary outcome will be the proportion of women exclusively breastfeeding at 3 months. Secondary outcomes will compare: infant feeding practices and attitudes, social support, breastfeeding difficulties, breastfeeding self efficacy and utilisation of breastfeeding support services. Follow-up at 6 months will compare exclusive and any breastfeeding and utilised support services. Analysis will be by intention to treat. This trial will contribute to future evidence syntheses identifying the most effective forms of breastfeeding support.",2017,"Secondary outcomes will compare: infant feeding practices and attitudes, social support, breastfeeding difficulties, breastfeeding self efficacy and utilisation of breastfeeding support services.","['Eligible participants will include primigravidae with singleton pregnancies who speak Croatian, attending six primary care obstetric practices', 'total sample size of 459, with computer generated stratified randomisation of 153 women per arm']","['general birth-related information with proactive support calls or standard care', 'Breastfeeding booklet and proactive phone calls']","['infant feeding practices and attitudes, social support, breastfeeding difficulties, breastfeeding self efficacy and utilisation of breastfeeding support services', 'exclusive breastfeeding rates', 'proportion of women exclusively breastfeeding at 3\u2009months', 'breastfeeding rates']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0037438'}, {'cui': 'C1998999', 'cui_str': 'Difficulty performing breast-feeding (finding)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1171181', 'cui_str': 'Breastfeeding support'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",459.0,0.0899385,"Secondary outcomes will compare: infant feeding practices and attitudes, social support, breastfeeding difficulties, breastfeeding self efficacy and utilisation of breastfeeding support services.","[{'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Zakarija-Grković', 'Affiliation': 'University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Drita', 'Initials': 'D', 'LastName': 'Puharić', 'Affiliation': 'University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Malički', 'Affiliation': 'University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Hoddinott', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, UK.'}]",Maternal & child nutrition,['10.1111/mcn.12249']
3190,27481309,"A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Brodalumab in Patients With Moderate-to-Severe Crohn's Disease.","OBJECTIVES


To assess the safety and efficacy of brodalumab, a human anti-interleukin-17 receptor monoclonal antibody, in patients with moderate-to-severe Crohn's disease (CD).
METHODS


Phase 2, randomized, double-blind, placebo-controlled, dose-ranging study in patients with moderate-to-severe CD and evidence of active inflammation. Patients were randomized 1:1:1:1 to receive brodalumab (210, 350, or 700 mg at baseline and week 4) or placebo. The primary end point was proportion of patients achieving Crohn's disease activity index (CDAI) remission (≤150) at week 6. Secondary end points included proportion of patients with CDAI response (reduction from baseline of ≥100) at week 6 and change from baseline in CDAI at week 6.
RESULTS


The study was terminated early based on an imbalance in worsening CD in active treatment groups. At the time of termination, 130 patients had been randomized. At week 6, remission rates were 3% (210 mg), 15% (350 mg), 9% (700 mg), and 3% (placebo) and CDAI response occurred in 16% (210 mg), 27% (350 mg), 15% (700 mg), and 13% (placebo) of patients. Mean change in CDAI at week 6 was -8.7 (95.3) (210 mg), -35.4 (105.6) (350 mg), -0.6 (105.9) (700 mg), and -28.2 (86.0) (placebo). Besides worsening of CD, overall incidences of adverse events were similar across treatment groups.
CONCLUSIONS


Treatment with brodalumab resulted in a disproportionate number of cases of worsening CD in patients with active CD and no evidence of meaningful efficacy. These analyses did not suggest additional safety risks of brodalumab beyond worsening of CD symptoms in patients with active CD.",2016,"Besides worsening of CD, overall incidences of adverse events were similar across treatment groups.
","[""Patients With Moderate-to-Severe Crohn's Disease"", 'patients with active CD', ""patients with moderate-to-severe Crohn's disease (CD"", 'patients with moderate-to-severe CD and evidence of active inflammation', '130 patients had been randomized']","['Brodalumab', 'Placebo', 'brodalumab', 'placebo']","['CDAI response', 'remission rates', 'proportion of patients with CDAI response', 'adverse events', ""proportion of patients achieving Crohn's disease activity index (CDAI) remission"", 'Mean change in CDAI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0333361', 'cui_str': 'Polymorphonuclear leukocyte infiltration'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}]","[{'cui': 'C3491331', 'cui_str': 'brodalumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index (assessment scale)""}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.490638,"Besides worsening of CD, overall incidences of adverse events were similar across treatment groups.
","[{'ForeName': 'Stephan R', 'Initials': 'SR', 'LastName': 'Targan', 'Affiliation': 'Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Feagan', 'Affiliation': 'Robarts Research Institute, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Vermeire', 'Affiliation': 'Department of Gastroenterology, University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Gil Y', 'Initials': 'GY', 'LastName': 'Melmed', 'Affiliation': 'Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Landers', 'Affiliation': 'Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Dalin', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'Amgen, Thousand Oaks, California, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Newmark', 'Affiliation': 'Amgen, Thousand Oaks, California, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Amgen, Thousand Oaks, California, USA.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chon', 'Affiliation': 'Amgen, Thousand Oaks, California, USA.'}, {'ForeName': 'Yi-Hsiang', 'Initials': 'YH', 'LastName': 'Hsu', 'Affiliation': 'Amgen, Thousand Oaks, California, USA.'}, {'ForeName': 'Shao-Lee', 'Initials': 'SL', 'LastName': 'Lin', 'Affiliation': 'Amgen, Thousand Oaks, California, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': 'Amgen, Thousand Oaks, California, USA.'}]",The American journal of gastroenterology,['10.1038/ajg.2016.298']
3191,32210370,"Correction: Augmenting extinction learning with D-cycloserine reduces return of fear: a randomized, placebo-controlled fMRI study.",An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,[],"['extinction learning with D-cycloserine', 'placebo']",['return of fear'],[],"[{'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}]",,0.0893736,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ebrahimi', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. claudia.ebrahimi@charite.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gechter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schlagenhauf', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Alfons O', 'Initials': 'AO', 'LastName': 'Hamm', 'Affiliation': 'Department of Biological and Clinical Psychology/Psychotherapy, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0658-3']
3192,32012036,"Challenges and Lessons Learned From a Mobile Health, Web-Based Human Papillomavirus Intervention for Female Korean American College Students: Feasibility Experimental Study.","BACKGROUND


Mobile health (mHealth) and Web-based research methods are becoming more commonplace for researchers. However, there is a lack of mHealth and Web-based human papillomavirus (HPV) prevention experimental studies that discuss potential issues that may arise.
OBJECTIVE


This study aimed to assess the feasibility of research procedures and discuss the challenges and lessons learned from an mHealth and Web-based HPV prevention experimental study targeting female Korean American college students in the United States.
METHODS


A pilot randomized controlled trial (RCT) was conducted in an mHealth and Web-based platform with 104 female Korean American college students aged 18-26 years between September 2016 and December 2016. Participants were randomized to either the experimental group (a storytelling video intervention) or the comparison group (a nonnarrative, information-based intervention). Outcomes included the feasibility of research procedures (recruitment, eligibility, randomization, and retention).
RESULTS


From September 2016 to October 2016, we recorded 225 entries in our initial eligibility survey. The eligibility rate was 54.2% (122/225). This study demonstrated a high recruitment rate (95.6%, 111/122) and retention rate (83.7%, 87/104) at the 2-month follow-up.
CONCLUSIONS


Findings from this study demonstrated sufficient feasibility in terms of research procedures to justify a full-scale RCT. Given the increased possibility of invalid or misrepresentative entries in mHealth and Web-based studies, strategies for detection and prevention are critical.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN12175285; http://www.isrctn.com/ISRCTN12175285.",2020,"Participants were randomized to either the experimental group (a storytelling video intervention) or the comparison group (a nonnarrative, information-based intervention).","['From September 2016 to October 2016, we recorded 225 entries in our initial eligibility survey', 'Female Korean American College Students', '104 female Korean American college students aged 18-26 years between September 2016 and December 2016', 'female Korean American college students in the United States']","['Lessons Learned From a Mobile Health, Web-Based Human Papillomavirus Intervention', 'storytelling video intervention) or the comparison group (a nonnarrative, information-based intervention']","['feasibility of research procedures (recruitment, eligibility, randomization, and retention', 'eligibility rate', 'retention rate']","[{'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0597921', 'cui_str': 'Korean Americans'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0035168'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.115462,"Participants were randomized to either the experimental group (a storytelling video intervention) or the comparison group (a nonnarrative, information-based intervention).","[{'ForeName': 'Minjin', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'University of Massachusetts Medical School, Department of Population and Quantitative Health Sciences, Worcester, MA, United States.'}, {'ForeName': 'Haeok', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'University of Massachusetts Boston, College of Nursing and Health Sciences, Boston, MA, United States.'}, {'ForeName': 'Jeroan', 'Initials': 'J', 'LastName': 'Allison', 'Affiliation': 'University of Massachusetts Medical School, Department of Population and Quantitative Health Sciences, Worcester, MA, United States.'}]",JMIR formative research,['10.2196/14111']
3193,31326629,Hidden blood loss following 2- to 3-level posterior lumbar fusion.,"BACKGROUND CONTEXT


Patients undergoing single-level posterior lumbar decompression and fusion (PLDF) usually do not need transfusions. However, patients undergoing two or three-level PLDF occasionally require transfusion postoperatively even when estimated blood loss (EBL) or blood loss from drains appears acceptable. Estimating the volume of HBL is critical in perioperative fluid management.
PURPOSE


To determine the volume of hidden blood loss (HBL) in two- or three-level PLDF.
STUDY DESIGN


Single-center, multisurgeon, secondary analysis from a prospective randomized clinical trial of cell saver use.
PATIENT SAMPLE


Patients enrolled in a prospective randomized trial of cell saver undergoing two- or three-level PLDF were included in this analysis.
METHODS


Total blood loss was calculated using four estimation formulas including Bourke's, Gross', Camarasa's, and Lopez-Picado's formulas. HBL was determined by subtracting the visible loss (EBL and blood loss from drains) from the calculated total blood loss.
RESULTS


A total of 89 patients (36 males, mean age 62 years) were included. Seventy-five patients underwent open two-level fusion while 14 had three-level fusions. Intervertebral fusion was performed in 20 patients. Mean surgical time was 261 minutes, and EBL was 685 mL. Mean blood loss from drains was 824 mL. Seventy patients received allogenic blood whereas 47 cell saver blood reinfused intraoperatively. HBL was calculated to be 678 mL, 963 mL, 1,267 mL, and 819 mL using each formula.
CONCLUSIONS


HBL following two or three-level PLDF was substantial and more than EBL. Postoperative management of blood loss should take HBL into account.",2019,"Mean surgical time was 261 minutes, and EBL was 685 mL. Mean blood loss from drains was","['SAMPLE\n\n\nPatients enrolled in a prospective randomized trial of cell saver undergoing two- or three-level PLDF were included in this analysis', '824 mL. Seventy patients received', '89 patients (36 males, mean age 62 years', 'Seventy-five patients underwent open two-level fusion while 14 had three-level fusions', '20 patients']",['allogenic blood'],"['HBL', 'Hidden blood loss', 'Mean surgical time', 'volume of hidden blood loss (HBL', 'blood loss (EBL) or blood loss', 'Total blood loss']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}]",[{'cui': 'C0005768'}],"[{'cui': 'C1719994', 'cui_str': 'Animal hide'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}]",75.0,0.0739195,"Mean surgical time was 261 minutes, and EBL was 685 mL. Mean blood loss from drains was","[{'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Ogura', 'Affiliation': 'Norton Leatherman Spine Center, 210 East Gray St, Suite 900, Louisville, KY 40204, USA. Electronic address: yojitotti1223@gmail.com.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Dimar Ii', 'Affiliation': 'Norton Leatherman Spine Center, 210 East Gray St, Suite 900, Louisville, KY 40204, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Gum', 'Affiliation': 'Norton Leatherman Spine Center, 210 East Gray St, Suite 900, Louisville, KY 40204, USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Crawford', 'Affiliation': 'Norton Leatherman Spine Center, 210 East Gray St, Suite 900, Louisville, KY 40204, USA.'}, {'ForeName': 'Mladen', 'Initials': 'M', 'LastName': 'Djurasovic', 'Affiliation': 'Norton Leatherman Spine Center, 210 East Gray St, Suite 900, Louisville, KY 40204, USA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Glassman', 'Affiliation': 'Norton Leatherman Spine Center, 210 East Gray St, Suite 900, Louisville, KY 40204, USA.'}, {'ForeName': 'Leah Y', 'Initials': 'LY', 'LastName': 'Carreon', 'Affiliation': 'Norton Leatherman Spine Center, 210 East Gray St, Suite 900, Louisville, KY 40204, USA.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2019.07.010']
3194,31298571,Comparison of Diode Laser (980 nm) Enucleation  vs  Holmium Laser Enucleation of the Prostate for the Treatment of Benign Prostatic Hyperplasia: A Randomized Controlled Trial with 12-Month Follow-Up.,"Objective:  To compare the clinical efficacy and safety between diode laser (980 nm) enucleation of the prostate (DiLEP) and holmium laser enucleation of the prostate (HoLEP) for treating benign prostatic hyperplasia (BPH).  Patients and Methods:  One hundred twenty-six BPH patients in our hospital from December 2016 to December 2017 were enrolled in this study. They were randomized to the DiLEP group or HoLEP group, which were administrated with DiLEP and HoLEP treatment, respectively. The patient's characteristics, such as age, body mass index, comorbidities, prostate volume, and prostate-specific antigen, were recorded before surgery. The perioperative outcomes and complications were also compared. The maximum flow rate (Qmax), postvoid residual (PVR), international prostate symptom score (IPSS), and quality-of-life (QoL) score were assessed at baseline and 3, 6, and 12 months postoperatively.  Results:  No significant differences were observed for the patient's baseline characteristics between both groups. For the perioperative outcomes, including operative time, resected tissue weight, catheter duration, and hospital stay, no significant difference was found between the two groups. However, the DiLEP group showed less blood loss and decrease in hemoglobin compared with the HoLEP group. The incidence of early or late complications was similar for both groups. The Qmax, PVR, IPSS, and QoL for both groups of patients were dramatically improved after surgery. By comparing the Qmax, PVR, IPSS, and QoL between the two groups, no significant differences were detected in the 3-, 6-, or 12-month follow-up.  Conclusions:  This study demonstrated that both DiLEP and HoLEP are efficient and safe treatments for BPH patients. DiLEP showed less blood loss and decrease in hemoglobin than HoLEP, which indicated that the diode laser (980 nm) generates a better hemostasis effect.",2019,"By comparing the Qmax, PVR, IPSS, and QoL between the two groups, no significant differences were detected in the 3-, 6-, or 12-month follow-up.  ","['One hundred twenty-six BPH patients in our hospital from December 2016 to December 2017 were enrolled in this study', 'treating benign prostatic hyperplasia (BPH', 'Benign Prostatic Hyperplasia', 'BPH patients']","['diode laser', 'Diode Laser (980\u2009nm) Enucleation  vs  Holmium Laser Enucleation', 'DiLEP and HoLEP', 'DiLEP', 'HoLEP', 'diode laser (980\u2009nm) enucleation of the prostate (DiLEP) and holmium laser enucleation of the prostate (HoLEP']","['incidence of early or late complications', 'blood loss', 'maximum flow rate (Qmax), postvoid residual (PVR), international prostate symptom score (IPSS), and quality-of-life (QoL) score', 'hemostasis effect', 'operative time, resected tissue weight, catheter duration, and hospital stay', 'perioperative outcomes and complications', 'Qmax, PVR, IPSS, and QoL', 'hemoglobin', 'clinical efficacy and safety']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",126.0,0.0557834,"By comparing the Qmax, PVR, IPSS, and QoL between the two groups, no significant differences were detected in the 3-, 6-, or 12-month follow-up.  ","[{'ForeName': 'Gaofei', 'Initials': 'G', 'LastName': 'He', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Bohan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Chuanjun', 'Initials': 'C', 'LastName': 'Du', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jiaming', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}]",Journal of endourology,['10.1089/end.2019.0341']
3195,31561960,Phase I/IIa Trial of Atorvastatin in Patients with Acute Kawasaki Disease with Coronary Artery Aneurysm.,"OBJECTIVES


To determine the safety, tolerability, pharmacokinetics, and immunomodulatory effects of a 6-week course of atorvastatin in patients with acute Kawasaki disease with coronary artery (CA) aneurysm (CAA).
STUDY DESIGN


This was a Phase I/IIa 2-center dose-escalation study of atorvastatin (0.125-0.75 mg/kg/day) in 34 patients with Kawasaki disease (aged 2-17 years) with echocardiographic evidence of CAA. We measured levels of the brain metabolite 24(S)-hydroxycholesterol (24-OHC), serum lipids, acute-phase reactants, liver enzymes, and creatine phosphokinase; peripheral blood mononuclear cell populations; and CA internal diameter normalized for body surface area before atorvastatin treatment and at 2 and 6 weeks after initiation of atorvastatin treatment.
RESULTS


A 6-week course of up to 0.75 mg/kg/day of atorvastatin was well tolerated by the 34 subjects (median age, 5.3 years; IQR, 2.6-6.4 years), with no serious adverse events attributable to the study drug. The areas under the curve for atorvastatin and its metabolite were larger in the study subjects compared with those reported in adults, suggesting a slower rate of metabolism in children. The 24-OHC levels were similar between the atorvastatin-treated subjects and matched controls.
CONCLUSIONS


Atorvastatin was safe and well tolerated in our cohort of children with acute Kawasaki disease and CAA. A Phase III efficacy trial is warranted in this patient population, which may benefit from the known anti-inflammatory and immunomodulatory effects of this drug.",2019,"(24-OHC), serum lipids, acute-phase reactants, liver enzymes, and creatine phosphokinase; peripheral blood mononuclear cell populations; and CA internal diameter normalized for body surface area before atorvastatin treatment and at 2 and 6 weeks after initiation of atorvastatin treatment.
","['Patients with Acute Kawasaki Disease with Coronary Artery Aneurysm', 'patients with acute Kawasaki disease with coronary artery (CA) aneurysm (CAA', '34 patients with Kawasaki disease (aged 2-17\xa0years) with echocardiographic evidence of CAA', 'children with acute Kawasaki disease and CAA']","['atorvastatin', 'Atorvastatin']","['24-OHC), serum lipids, acute-phase reactants, liver enzymes, and creatine phosphokinase; peripheral blood mononuclear cell populations; and CA internal diameter normalized for body surface area', 'tolerated', 'safety, tolerability, pharmacokinetics, and immunomodulatory effects', '24-OHC levels', 'safe and well tolerated', 'brain metabolite 24(S)-hydroxycholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026691', 'cui_str': 'Acute febrile mucocutaneous lymph node syndrome'}, {'cui': 'C0010051', 'cui_str': 'Aneurysm of coronary vessels'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C1842937', 'cui_str': 'Aural Atresia, Congenital'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0001347', 'cui_str': 'Acute phase reactant'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C2314970', 'cui_str': 'Internal diameter'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0208133', 'cui_str': '24-hydroxycholesterol'}]",34.0,0.0151144,"(24-OHC), serum lipids, acute-phase reactants, liver enzymes, and creatine phosphokinase; peripheral blood mononuclear cell populations; and CA internal diameter normalized for body surface area before atorvastatin treatment and at 2 and 6 weeks after initiation of atorvastatin treatment.
","[{'ForeName': 'Adriana H', 'Initials': 'AH', 'LastName': 'Tremoulet', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA. Electronic address: atremoulet@ucsd.edu.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Biostatistics Research Center, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Pei-Ni', 'Initials': 'PN', 'LastName': 'Jone', 'Affiliation': ""Pediatric Cardiology, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Brookie M', 'Initials': 'BM', 'LastName': 'Best', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, CA.""}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Duxbury', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, CA.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Franco', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.""}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Printz', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.""}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Dominguez', 'Affiliation': ""Pediatric Infectious Disease, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Heizer', 'Affiliation': ""Pediatric Infectious Disease, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Marsha S', 'Initials': 'MS', 'LastName': 'Anderson', 'Affiliation': ""Pediatric Infectious Disease, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Glodé', 'Affiliation': ""Pediatric Infectious Disease, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Biostatistics Research Center, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Padilla', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.""}, {'ForeName': 'Chisato', 'Initials': 'C', 'LastName': 'Shimizu', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.""}, {'ForeName': 'Emelia', 'Initials': 'E', 'LastName': 'Bainto', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Pancheri', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.""}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'Department of Pediatrics, Stanford University, Stanford, CA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Whitin', 'Affiliation': 'Department of Pediatrics, Stanford University, Stanford, CA.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Burns', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.07.064']
3196,32438783,Changes in erythropoietin and vascular endothelial growth factor following the use of different altitude training concepts.,"BACKGROUND


Erythropoietin (EPO) and vascular endothelial growth factor (VEGF) are important factors regulating erythropoiesis and angiogenesis. Altitude/hypoxic training may induce elevated VEGF-A and EPO levels. However, it appears that the range of adaptive changes depends largely on the training method used. Therefore, we investigated the changes in EPO and VEGF-A levels in athletes using three different altitude/hypoxic training concepts.
METHODS


Thirty-four male cyclists were randomly divided into four groups: LH-TL group (""live high-train low"" protocol), HiHiLo (""live high - base train high - interval train low"" procedure), IHT (""intermittent hypoxic training"") and control group (CN, normoxic training). The same 4-week training program was used in all groups. Blood samples were taken before and after each training week in order to evaluate serum EPO and VEGF-A levels.
RESULTS


In the LH-TL and HiHiLo groups, EPO increased (P<0.001) after 1st week and remained elevated until 3rd week of altitude training. In the IHT and CN groups, EPO did not change significantly. VEGF-A was higher (P<0.001) after 2nd and 3rd week of training in the IHT group. In the HiHiLo group, VEGF-A changed (P<0.05) only after 3rd week. No significant changes of VEGF-A were noted in the LH-TL and CN groups.
CONCLUSIONS


Altitude/hypoxic training is effective in increasing VEGF-A and EPO levels. However, a training method plays a key role in the pattern of adaptations. EPO level increase only when an adequate hypoxic dose is provided, whereas VEGF-A increases when the hypoxic exposure is combined with exercise, particularly at high intensity.",2020,"In the HiHiLo group, VEGF-A changed (P<0.05) only after 3rd week.",['Thirty-four male cyclists'],"['Altitude/hypoxic training', 'Erythropoietin (EPO) and vascular endothelial growth factor (VEGF', 'LH-TL group (""live high-train low"" protocol), HiHiLo (""live high - base train high - interval train low"" procedure), IHT (""intermittent hypoxic training"") and control group (CN, normoxic training']","['serum EPO and VEGF-A levels', 'EPO level', 'elevated VEGF-A and EPO levels', 'VEGF-A', 'VEGF-A and EPO levels', 'EPO and VEGF-A levels', 'EPO']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202001', 'cui_str': 'Erythropoietin measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}]",34.0,0.0137493,"In the HiHiLo group, VEGF-A changed (P<0.05) only after 3rd week.","[{'ForeName': 'Alicja', 'Initials': 'A', 'LastName': 'Wiśniewska', 'Affiliation': 'Department of Sports Training, the Jerzy Kukuczka Academy of Physical Education in Katowice, Faculty of Physical Education, Katowice, Poland.'}, {'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Płoszczyca', 'Affiliation': 'Department of Kinesiology, Institute of Sport, Warsaw, Poland - kamila.ploszczyca@insp.waw.pl.'}, {'ForeName': 'Miłosz', 'Initials': 'M', 'LastName': 'Czuba', 'Affiliation': 'Department of Sports Training, the Jerzy Kukuczka Academy of Physical Education in Katowice, Faculty of Physical Education, Katowice, Poland.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10404-3']
3197,32438784,Effects of a 4-month judo program on gait performance in older adults.,"BACKGROUND


Falls prevention is a critical goal of training program for older individuals. This study explored the effects of a judo program on gait performance in older adults.
METHODS


Pre- and post-intervention (15 weeks, 1-hr session, twice a week) step length (cm), gait cycle time (s), speed (m·s-1) and cadence (step·min-1) mean values (AVG) and coefficients of variation (CV) were assessed in a judo (JG: N.=16 novice judoka; age=69.3±3.9 years) and a control (CG: N.=14 healthy older adults; age=70.1±4.5 years) group. Two 3 (motor complexity: flat, corridor, hurdling) ×2 (group: JG, CG) ×2 (time: pre, post) MANOVAs with repeated measures were applied to ascertain differences in gait parameters.
RESULTS


A significant Time×Motor Complexity×Group interaction was found for AVG and CV. For AVG, JG showed improvements for flat and hurdling conditions in step length (flat: ∆=+2.6%, d=0.4; hurdling: ∆=+3.2%, d=0.4), gait cycle (flat: ∆=-4.3%, d=0.4; hurdling: ∆=-4.0%, d=0.5), speed (flat: ∆=+6.6%, d=0.7; hurdling: ∆=+6.7%, d=0.6) and cadence (flat: ∆=4.3%, d=0.4; hurdling: ∆=3.9%, d=0.5). For CV, JG improved step length for flat (∆=-20.9%, d=0.6) and hurdling (∆=-16.3%, d=0.8) conditions, whereas CG showed a deterioration in the step length for the corridor condition (∆=+22.3%, d=0.7).
CONCLUSIONS


The findings demonstrated the effectiveness of an adapted judo program for improving gait performance in older individuals, suggesting a potential protective effect for fall risk.",2020,"For CV, JG improved step length for flat (∆=-20.9%, d=0.6) and hurdling (∆=-16.3%, d=0.8) conditions, whereas CG showed a deterioration in the step length for the corridor condition (∆=+22.3%, d=0.7).
","['older individuals', 'older adults']","['judo program', 'adapted judo program']","['gait cycle time (s), speed (m·s-1) and cadence (step·min-1) mean values (AVG) and coefficients of variation (CV', 'gait performance', 'gait cycle', 'step length for flat', 'gait parameters']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0172832,"For CV, JG improved step length for flat (∆=-20.9%, d=0.6) and hurdling (∆=-16.3%, d=0.8) conditions, whereas CG showed a deterioration in the step length for the corridor condition (∆=+22.3%, d=0.7).
","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Ciaccioni', 'Affiliation': 'Department of Movement, Human and Health Sciences, University of Rome Foro Italico, Rome, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Capranica', 'Affiliation': 'Department of Movement, Human and Health Sciences, University of Rome Foro Italico, Rome, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Forte', 'Affiliation': 'Department of Movement, Human and Health Sciences, University of Rome Foro Italico, Rome, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Pesce', 'Affiliation': 'Department of Movement, Human and Health Sciences, University of Rome Foro Italico, Rome, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Condello', 'Affiliation': 'Graduate Institute of Sports Training, Institute of Sports Sciences, University of Taipei, Taipei, Taiwan - giancarlo.condello@gmail.com.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10446-8']
3198,32438817,Effectiveness Comparison of Dexmedetomidine and Remifentanil for Perioperative Management in Patients Undergoing Endoscopic Sinus Surgery.,"BACKGROUND


For patients undergoing endoscopic sinus surgery, intranasal injection of epinephrine can cause acute increases in heart rate and blood pressure.
OBJECTIVE


Among the drugs for reducing hyperdynamic effects, dexmedetomidine and remifentanil are expected to blunt the acute hemodynamic responses after intranasal injection of epinephrine. Our study compared a difference in the 2 drugs in their abilities to blunt the hemodynamic responses in intraoperative period and postoperative profile.
METHODS


In this study, the patients were randomly divided into the dexmedetomidine and remifentanil groups. During the intraoperative period, the hemodynamic values were recorded. The surgical condition was assessed by a single surgeon. During the postoperative period, hemodynamic values, sedation scale score, and pain score were recorded.
RESULT


No significant differences in hemodynamic variables were found between the groups before and after intranasal injection of epinephrine. Comparison of the group mean values before endotracheal intubation revealed that the blood pressure values in the remifentanil group were significantly lower than those in the dexmedetomidine group. At 2 minutes after endotracheal intubation, blood pressure and heart rate values in the remifentanil group were significantly lower than those in the dexmedetomidine group. The sedation score was significantly lower in the dexmedetomidine group on arrival and at 30 minutes after arrival at the postanesthetic care unit ( P  < .001 and  P  = .001, respectively). At 30 and 60 minutes after the operation, the pain scores were significantly lower in the dexmedetomidine group ( P  = .015 and  P  = .001, respectively).
CONCLUSION


Dexmedetomidine had better postoperative sedative and analgesic effects than remifentanil for patients undergoing endoscopic sinus surgery in this study. Remifentanil and dexmedetomidine attenuated acute hemodynamic responses to be within normal ranges after intranasal injection of epinephrine, and no significant differences in terms of hemodynamic variables. Remifentanil was superior to dexmedetomidine in inducing hypotension during endotracheal intubation.",2020,"Remifentanil and dexmedetomidine attenuated acute hemodynamic responses to be within normal ranges after intranasal injection of epinephrine, and no significant differences in terms of hemodynamic variables.","['patients undergoing endoscopic sinus surgery', 'Patients Undergoing Endoscopic Sinus Surgery']","['dexmedetomidine and remifentanil', 'Remifentanil', 'Dexmedetomidine', 'Dexmedetomidine and Remifentanil', 'remifentanil', 'epinephrine', 'dexmedetomidine']","['pain scores', 'heart rate and blood pressure', 'blood pressure and heart rate values', 'postoperative sedative and analgesic effects', 'blood pressure values', 'sedation score', 'acute hemodynamic responses', 'hemodynamic values, sedation scale score, and pain score', 'hypotension', 'hemodynamic variables', 'hemodynamic values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.0436728,"Remifentanil and dexmedetomidine attenuated acute hemodynamic responses to be within normal ranges after intranasal injection of epinephrine, and no significant differences in terms of hemodynamic variables.","[{'ForeName': 'Hyub', 'Initials': 'H', 'LastName': 'Huh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong Jun', 'Initials': 'JJ', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun Young', 'Initials': 'HY', 'LastName': 'Seong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Hag', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Zhoo', 'Initials': 'SZ', 'LastName': 'Yoon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jang Eun', 'Initials': 'JE', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}]",American journal of rhinology & allergy,['10.1177/1945892420927291']
3199,32438828,Participation in and outcomes from a 12-month tailored exercise programme for people with multiple sclerosis (MSTEP©): a randomized trial.,"OBJECTIVE


To estimate, among people with multiple sclerosis, the extent to which a personally tailored exercise programme (MSTEP©) resulted in greater improvements in exercise capacity and related outcomes over 12 months in comparison with general exercise guidelines.
DESIGN


Two-group randomized trial.
SUBJECTS


Ambulatory and sedentary.
INTERVENTIONS


MSTEP©, a personally adapted exercise regimen done on most days including two days of high intensity exercise; guidelines recommending 30 minutes of moderate intensity aerobic and strength training two times per week.
MAIN MEASURES


Primary outcome was peak oxygen consumption (VO 2peak ) at 12 months; secondary outcomes were composite measures of physical function, fatigue, and health-related quality of life.
RESULTS


In total, 137 people were randomized, 66 were lost over 12 months leaving 71 with outcome data, 34 in MSTEP© group, and 37 in the Guideline group. Exercise enjoyment and confidence and exercise-induced fatigue predicted retention. There were no differences between groups on the proportion making a 10% increase in VO 2peak  (27.1% MSTEP© vs 29.6% Guidelines; OR: 0.83; 95% CI: 0.23-3.08) by the 12 month assessment. The effect on fatigue was larger in the MSTEP© group than the Guideline groups (OR: 1.59; 95% CI: 0.93-2.74), the effect on physical function was more modest (OR: 1.35; 95% CI: 0.80-2.25), and null for health-related quality of life outcomes.
CONCLUSIONS


The disappointing exercise retention suggests that people with multiple sclerosis may not consider exercise important to their brain health. Either type of exercise resulted in stable exercise capacity over 1 year in those sticking with the programme.",2020,The effect on fatigue was larger in the MSTEP,"['people with multiple sclerosis', 'people with multiple sclerosis (MSTEP©', '137 people were randomized, 66 were lost over 12\u2009months leaving 71 with outcome data, 34 in MSTEP© group, and 37 in the Guideline group', 'Ambulatory and sedentary']","['MSTEP', 'tailored exercise programme']","['VO 2peak', 'physical function', 'fatigue', 'stable exercise capacity', 'peak oxygen consumption (VO 2peak ', 'physical function, fatigue, and health-related quality of life', 'Exercise enjoyment and confidence and exercise-induced fatigue predicted retention']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C2732413', 'cui_str': 'Postexertional fatigue'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",137.0,0.195875,The effect on fatigue was larger in the MSTEP,"[{'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Mayo', 'Affiliation': 'Center for Outcomes Research and Evaluation, Research Institute of McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Kedar Kv', 'Initials': 'KK', 'LastName': 'Mate', 'Affiliation': 'Center for Outcomes Research and Evaluation, Research Institute of McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Reid', 'Affiliation': 'Human Kinetics Department, St Francis Xavier University, Antigonish, NS, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Duquette', 'Affiliation': 'Départment de Neurologie, Faculté de Médecine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Lapierre', 'Affiliation': 'Montreal Neurological Hospital, Department of Neurology and Neurosurgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Barclay', 'Affiliation': 'College of Rehabilitation Sciences, Rady Faculty of Health Sciences, Department of Physical Therapy, University of Manitoba, Winnipeg, MA, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bayley', 'Affiliation': 'Toronto Rehabilitation Center, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bartlett', 'Affiliation': 'Division of Clinical Epidemiology, Department of Medicine, Center for Outcomes Research and Evaluation, Research Institute of McGill University Health Centre, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Andersen', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, QC, Canada.'}]",Clinical rehabilitation,['10.1177/0269215520923089']
3200,32438905,Thigh musculature stiffness during active muscle contraction after anterior cruciate ligament injury.,"BACKGROUND


Altered motor unit (MU) activity has been identified after anterior cruciate ligament (ACL) injury, but its effect on muscle tissue properties is unknown. The purpose of this study was to compare thigh musculature muscle stiffness between control and ACL-injured subjects.
METHODS


Thirty ACL-injured subjects and 25 control subjects were recruited. Subjects completed a randomized protocol of isometric contractions while electromyography (EMG) signals were recorded. Three maximum voluntary isometric contractions (MVIC) determined peak force for 10 and 25% MVIC trials. Shear wave elastography was captured during each 10 and 25% MVIC trials.
RESULTS


Differences in muscle stiffness were assessed between limbs and groups. 12 months post-surgery had higher stiffness for VM 0% MVIC, VL 0 and 10% MVIC, and ST 10 and 25% MVIC (all p ≤ 0.04).
CONCLUSION


Thigh musculature stiffness changed throughout rehabilitation and remained altered at 12 months after ACL reconstruction.",2020,12 months post-surgery had higher stiffness for VM,"['control and ACL-injured subjects', 'anterior cruciate ligament injury', 'Thirty ACL-injured subjects and 25 control subjects were recruited', 'anterior cruciate ligament (ACL) injury']",[],"['maximum voluntary isometric contractions (MVIC) determined peak force', 'muscle stiffness', 'Shear wave elastography', 'thigh musculature muscle stiffness', 'Thigh musculature stiffness', 'higher stiffness for VM']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",[],"[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205250', 'cui_str': 'High'}]",30.0,0.0278514,12 months post-surgery had higher stiffness for VM,"[{'ForeName': 'April L', 'Initials': 'AL', 'LastName': 'McPherson', 'Affiliation': 'Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Nathaniel A', 'Initials': 'NA', 'LastName': 'Bates', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Clifton R', 'Initials': 'CR', 'LastName': 'Haider', 'Affiliation': 'Special Purpose Processor Development Group, Department of Physiology and Biomedical Engineering, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nagai', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Hewett', 'Affiliation': 'Sparta Science, Menlo Park, CA, USA.'}, {'ForeName': 'Nathan D', 'Initials': 'ND', 'LastName': 'Schilaty', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA. Schilaty.nathan@mayo.edu.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03342-x']
3201,32438988,Frequency and Impact of Bleeding on Outcome in Patients With Cardiogenic Shock.,"OBJECTIVES


This study sought to determine frequency, associated factors, and impact of bleeding in infarct-related cardiogenic shock.
BACKGROUND


Early revascularization is associated with improved survival in patients with acute myocardial infarction complicated by cardiogenic shock. On the downside, invasive treatment and accompanying antithrombotic therapies are associated with an increased bleeding risk. Prospective data assessing the incidence, severity, risk factors, and prognostic implication of bleeding in patients with cardiogenic shock are scarce.
METHODS


As a pre-defined subanalysis of the CULPRIT-SHOCK (PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock) randomized trial, we examined distribution of bleeding events in 684 patients with infarct-related cardiogenic shock and compared patients with any bleeding to those without.
RESULTS


A total of 21.5% patients experienced at least 1 bleeding event until 30 days after randomization. The vast majority of bleeding (57%) occurred within the first 2 days of hospitalization. Patients with bleeding had prolonged catecholamine treatment and mechanical ventilation and there was a significant association with sepsis, peripheral ischemic complications, new atrial fibrillation, and ventricular fibrillation. In multivariable analysis, bleeding was associated with a significantly higher mortality (hazard ratio: 2.11; 95% confidence interval: 1.63 to 2.75; p < 0.0001). Treatment with active mechanical support by extracorporeal membrane oxygenation or Impella emerged as the major risk factor for bleeding.
CONCLUSIONS


Risk of bleeding in infarct-related cardiogenic shock is high and associated with increased mortality.",2020,"In multivariable analysis, bleeding was associated with a significantly higher mortality (hazard ratio: 2.11; 95% confidence interval: 1.63 to 2.75; p < 0.0001).","['684 patients with infarct-related cardiogenic shock and compared patients with any bleeding to those without', 'Patients with Acute Myocardial Infarction and Cardiogenic Shock', 'patients with acute myocardial infarction complicated by cardiogenic shock', 'patients with cardiogenic shock are scarce', 'Patients With Cardiogenic Shock']",['CULPRIT-SHOCK (PCI Strategies'],"['bleeding risk', 'mortality', 'sepsis, peripheral ischemic complications, new atrial fibrillation, and ventricular fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}]","[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}]",684.0,0.0720031,"In multivariable analysis, bleeding was associated with a significantly higher mortality (hazard ratio: 2.11; 95% confidence interval: 1.63 to 2.75; p < 0.0001).","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Freund', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig, Germany; German Center for Cardiovascular Research, partner site Hamburg/Kiel/Lübeck, Lübeck, Germany; Leipzig Heart Institute, Leipzig, Germany. Electronic address: anne.freund@medizin.uni-leipzig.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Jobs', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig, Germany; German Center for Cardiovascular Research, partner site Hamburg/Kiel/Lübeck, Lübeck, Germany; Department of Cardiology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Lurz', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig, Germany.'}, {'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'German Center for Cardiovascular Research, partner site Hamburg/Kiel/Lübeck, Lübeck, Germany; Department of Cardiology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Meyer-Saraei', 'Affiliation': 'German Center for Cardiovascular Research, partner site Hamburg/Kiel/Lübeck, Lübeck, Germany; Department of Cardiology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'ACTION Study Group, Centre Hospitalier Universitaire Pitié-Salpêtrière, Sorbonne Université, Paris, France.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Department of Cardiology, Wilhelminenspital, Sigmund Freud University Medical School, Vienna, Austria.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Noc', 'Affiliation': 'Center of Intensive Internal Medicine, University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany; Medizinische Klinik B, Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Taoufik', 'Initials': 'T', 'LastName': 'Ouarrak', 'Affiliation': 'Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig, Germany; German Center for Cardiovascular Research, partner site Hamburg/Kiel/Lübeck, Lübeck, Germany; Department of Cardiology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.02.042']
3202,32442146,Impact of Co-Designed Game Learning on Cultural Safety in Colombian Medical Education: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Cultural safety encourages practitioners to examine how their own culture shapes their clinical practice and to respect their patients' worldviews. Lack of cultural safety in health care is linked to stigma and discrimination toward culturally diverse patients. Training in cultural safety poses considerable challenges. It is an unappealing subject for medical students and requires behavioral changes in their clinical practice. Game jams-collaborative workshops to create and play games-have recently shown effectiveness and engaging potential in university-level education.
OBJECTIVE


The trial aims to determine if medical students' participation in a game jam to design an educational game on cultural safety is more effective than a standard lesson on cultural safety in terms of change in the students' self-reported intended patient-oriented behavior.
METHODS


A parallel-group, 2-arm, randomized controlled trial with a 1:1 allocation ratio will randomize 340 medical students and 60 medical interns (n=400) at the Faculty of Medicine at La Sabana University, Colombia (170 students and 30 medical interns to each arm). The intervention group will participate in an 8-hour game jam comprising (1) a preliminary lecture on cultural safety and game design, (2) a game building session where groups of students will create educational games about cultural safety, and (3) a play-test session in which students will play and learn from each other's games. The control group will receive a standard lesson, including a 2-hour lecture on cultural safety, followed by a 6-hour workshop to create posters about cultural safety. Web-based self-administered 30-item Likert-type questionnaires will assess cultural safety self-reported intended behavior before, immediately after, and 6 months after the intervention. An intention-to-treat approach will use a t test with 95% CIs to determine the significance of the effect of the intervention, including within- and between-group comparisons. The qualitative most significant change technique will explore the impact of the intervention on the clinical experience of the students.
RESULTS


Study enrollment began in July 2019. A total of 531 students completed the baseline survey and were randomized. Data collection is expected to be complete by July 2020, and results are expected in October 2020. The study was approved by the institutional review board of the Faculty of Medicine at McGill University (May 31, 2017).
CONCLUSIONS


The research will develop participatory methods in game-based learning co-design that might be relevant to other subjects. Ultimately, it should foster improved cultural safety skills for medical students, improve the quality of health services for diverse cultural groups, and contribute to enhanced population health. Game learning may provide an innovative solution to a long-standing and neglected problem in medical education, helping to meet the educational expectations and needs of millennial medical students.
CLINICALTRIAL


International Standard Randomized Controlled Trial Number (ISRCTN): 14261595; http://www.controlled-trials.com/ISRCTN14261595.",2020,"Game jams-collaborative workshops to create and play games-have recently shown effectiveness and engaging potential in university-level education.
","['medical students', 'Colombian Medical Education', '531 students completed the baseline survey and were randomized', '340 medical students and 60 medical interns (n=400) at the Faculty of Medicine at La Sabana University, Colombia (170 students and 30 medical interns to each arm', 'Faculty of Medicine at McGill University']","['Co-Designed Game Learning', ""8-hour game jam comprising (1) a preliminary lecture on cultural safety and game design, (2) a game building session where groups of students will create educational games about cultural safety, and (3) a play-test session in which students will play and learn from each other's games""]","['cultural safety skills', 'quality of health services']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0022337', 'cui_str': 'Jamaica'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]",531.0,0.096984,"Game jams-collaborative workshops to create and play games-have recently shown effectiveness and engaging potential in university-level education.
","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Pimentel', 'Affiliation': 'CIET-PRAM, Department of Family Medicine, McGill University, 3rd Floor, Suite 3005858 Chemin de la Côte-des-Neiges, Montreal, CA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cockcroft', 'Affiliation': 'CIET-PRAM, Department of Family Medicine, McGill University, 3rd Floor, Suite 3005858 Chemin de la Côte-des-Neiges, Montreal, CA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Andersson', 'Affiliation': 'CIET-PRAM, Department of Family Medicine, McGill University, 3rd Floor, Suite 3005858 Chemin de la Côte-des-Neiges, Montreal, CA.'}]",JMIR research protocols,['10.2196/17297']
3203,32442148,Patient Perception of Plain-Language Medical Notes Generated Using Artificial Intelligence Software: Pilot Mixed-Methods Study.,"BACKGROUND


Clinicians' time with patients has become increasingly limited due to regulatory burden, documentation and billing, administrative responsibilities, and market forces. These factors limit clinicians' time to deliver thorough explanations to patients. OpenNotes began as a research initiative exploring the ability of sharing medical notes with patients to help patients understand their health care. Providing patients access to their medical notes has been shown to have many benefits, including improved patient satisfaction and clinical outcomes. OpenNotes has since evolved into a national movement that helps clinicians share notes with patients. However, a significant barrier to the widespread adoption of OpenNotes has been clinicians' concerns that OpenNotes may cost additional time to correct patient confusion over medical language. Recent advances in artificial intelligence (AI) technology may help resolve this concern by converting medical notes to plain language with minimal time required of clinicians.
OBJECTIVE


This pilot study assesses patient comprehension and perceived benefits, concerns, and insights regarding an AI-simplified note through comprehension questions and guided interview.
METHODS


Synthea, a synthetic patient generator, was used to generate a standardized medical language which was then simplified using AI software. A multiple-choice comprehension assessment questionnaire was drafted with physician input. Study participants were recruited from inpatients at the University of Colorado Hospital. Participants were randomly assigned to be tested for their comprehension of the standardized medical language version or AI-generated plain-language version of the patient note. Following this, participants reviewed the opposite version of the note and participated in a guided interview. A Student t test was performed to assess for differences in comprehension assessment scores between plain-language and medical-language note groups. Multivariate modeling was performed to assess the impact of demographic variables on comprehension. Interview responses were thematically analyzed.
RESULTS


Twenty patients agreed to participate. The mean number of comprehension assessment questions answered correctly was found to be higher in the plain-language group compared with the medical-language group; however, the Student t test was found to be underpowered to determine if this was significant. Age, ethnicity, and health literacy were found to have a significant impact on comprehension scores by multivariate modeling. Thematic analysis of guided interviews highlighted patients' perceived benefits, concerns, and suggestions regarding such notes. Major themes of benefits were that simplified plain-language notes may (1) be more useable than unsimplified medical-language notes, (2) improve the patient-clinician relationship, and (3) empower patients through an enhanced understanding of their health care.
CONCLUSIONS


AI software may translate medical notes into plain-language notes that are perceived as beneficial by patients. Limitations included sample size, inpatient-only setting, and possible confounding factors. Larger studies are needed to assess comprehension. Insight from patient responses to guided interviews can guide the future study and development of this technology.",2020,"The mean number of comprehension assessment questions answered correctly was found to be higher in the plain-language group compared with the medical-language group; however, the Student t test was found to be underpowered to determine if this was significant.","['Twenty patients agreed to participate', 'Study participants were recruited from inpatients at the University of Colorado Hospital']",['standardized medical language version or AI-generated plain-language version of the patient note'],"['mean number of comprehension assessment questions', 'Interview responses', 'comprehension assessment scores', 'comprehension scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.036171,"The mean number of comprehension assessment questions answered correctly was found to be higher in the plain-language group compared with the medical-language group; however, the Student t test was found to be underpowered to determine if this was significant.","[{'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bala', 'Affiliation': 'College of Medicine, University of Central Florida, 6850 Lake Nona Blvd, Orlando, US.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Keniston', 'Affiliation': 'Division of Hospital Medicine, University of Colorado School of Medicine, Aurora, US.'}, {'ForeName': 'Marisha', 'Initials': 'M', 'LastName': 'Burden', 'Affiliation': 'Division of Hospital Medicine, University of Colorado School of Medicine, Aurora, US.'}]",JMIR formative research,['10.2196/16670']
3204,32442153,Women's Engagement With Pregnancy Lifestyle Activity and Nutrition: An Electronic Health and Dietetic Intervention to Promote Healthy Weight Gain in Pregnancy.,"BACKGROUND


Early excess and inadequate gestational weight gain (GWG) have been associated with negative outcomes for mother and child. The use of digital media to deliver pregnancy lifestyle interventions is increasing, but there is little data on participant engagement. The Pregnancy Lifestyle Activity and Nutrition (PLAN) intervention pilot study was an electronic health and dietetic-delivered intervention program promoting healthy GWG in early pregnancy.
OBJECTIVE


This study aimed to explore the interactions of participants with the program and to assess its acceptability.
METHODS


This study used both quantitative and qualitative methods using data from parent randomized controlled trial (ACTRN12617000725369). Quantitative data from 22 participants in the intervention arm who completed the study provided measures of the interactions participants had with the digital components of the program and with dietetic consultations. A descriptive qualitative analysis employed semistructured interviews with 9 participants to elicit views on the acceptability of the intervention and its components.
RESULTS


The electronic delivery of information and recording of weight from 8 to 20 weeks of gestation were universally accepted. Component (face-to-face dietitian, weight tracker, website information delivery, and SMS goal prompting) acceptability and engagement differed between individuals. A total of 4 key themes emerged from the qualitative analysis: supporting lifestyle change, component acceptability and value, delivery platforms, and engagement barriers.
CONCLUSIONS


The PLAN intervention and its delivery via a blend of personal dietetic consultations and digital program delivery was found to be acceptable and valuable to pregnant women. Individuals responded differently to various components, emphasizing the importance of including women in the development of lifestyle interventions and allowing participants to choose and tailor programs. Larger randomized controlled trials using these insights in a broader section of the community are needed to inform the iterative development of practical, time-efficient, and cost-effective ways of supporting optimal GWG with the potential to optimize outcomes for pregnant women and their child.",2020,The PLAN intervention and its delivery via a blend of personal dietetic consultations and digital program delivery was found to be acceptable and valuable to pregnant women.,"['pregnant women and their child', 'pregnant women', ""Women's Engagement With Pregnancy Lifestyle Activity and Nutrition"", '22 participants in the intervention arm who completed the study provided measures of the interactions participants had with the digital components of the program and with dietetic consultations']","['Electronic Health and Dietetic Intervention', 'electronic health and dietetic-delivered intervention program promoting healthy GWG']",[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",[],22.0,0.0728469,The PLAN intervention and its delivery via a blend of personal dietetic consultations and digital program delivery was found to be acceptable and valuable to pregnant women.,"[{'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Willcox', 'Affiliation': 'La Trobe University, Bundoora, AU.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chai', 'Affiliation': 'Telethon Kids Institute, Hospital AvenueNedlands, Perth, AU.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Beilin', 'Affiliation': 'The University of Western Australia, Perth, AU.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': 'The University of Western Australia, Perth, AU.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Silva', 'Affiliation': 'Joondalup Health Campus, Shenton Avenue, Perth, AU.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Neppe', 'Affiliation': 'Joondalup Health Campus, Shenton Avenue, Perth, AU.'}, {'ForeName': 'Rae-Chi', 'Initials': 'RC', 'LastName': 'Huang', 'Affiliation': 'Telethon Kids Institute, Hospital AvenueNedlands, Perth, AU.'}]",Journal of medical Internet research,['10.2196/17845']
3205,32442154,Feasibility and Utility of mHealth for the Remote Monitoring of Parkinson Disease: Randomized Controlled Trial.,"BACKGROUND


Mobile health, predominantly wearable technology and mobile apps, have been considered in Parkinson disease to provide valuable ecological data between face-to-face visits and improve monitoring of motor symptoms remotely.
OBJECTIVE


We explored the feasibility of using a technology-based mHealth platform comprising a smartphone in combination with a smartwatch and a pair of smart insoles, described in the this study as the PD_manager system, to collect clinically meaningful data. We also explored outcomes and disease-related factors that are important determinants to establish feasibility. Finally, we further validated a tremor evaluation method with data collected while patients performed their daily activities.
METHODS


PD_manager trial was an open-label parallel group randomized study. The mHeath platform consists of a wristband, a pair of sensor insoles, and a smartphone (with dedicated mobile Android apps and a knowledge platform) serving as the cloud backend. Compliance was assessed with statistical analysis and the factors affecting it using appropriate regression analysis. The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson's Disease Rating Scale estimations by clinicians were explored.
RESULTS


Of the 75 study participants, 65 (87%) completed the protocol. They used the PD_manager system for a median 11.57 (SD 3.15) days. Regression analysis suggests that the main factor associated with high use was caregivers' burden. Motor Aspects of Experiences of Daily Living and patients' self-rated health status also influence the system's use. Our algorithm provided clinically meaningful data for the detection and evaluation of tremor.
CONCLUSIONS


We found that PD patients, regardless of their demographics and disease characteristics, used the system for 11 to 14 days. The study further supports that mHealth can be an effective tool for the ecologically valid, passive, unobtrusive monitoring and evaluation of symptoms. Future studies will be required to demonstrate that an mHealth platform can improve disease management and care.
INTERNATIONAL REGISTERED REPORT


RR2-10.1186/s13063-018-2767-4.",2020,"The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson's Disease Rating Scale estimations by clinicians were explored.
","['Of the 75 study participants, 65 (87%) completed the protocol', 'Parkinson Disease']",['technology-based mHealth platform'],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]",[],75.0,0.0514528,"The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson's Disease Rating Scale estimations by clinicians were explored.
","[{'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Gatsios', 'Affiliation': 'Department of Neurology, Medical School, University of Ioannina, University Campus of Ioannina, Ioannina, GR.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Antonini', 'Affiliation': 'Department of Neuroscience, University of Padua, Padua, IT.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Gentile', 'Affiliation': 'Department of Neuroscience, University of Padua, Padua, IT.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Marcante', 'Affiliation': 'San Camillo Hospital Istituto Di Ricovero e Cura a Carattere Scientifico, Venice, IT.'}, {'ForeName': 'Clelia', 'Initials': 'C', 'LastName': 'Pellicano', 'Affiliation': 'Laboratory of Neuropsychiatry, Fondazione Santa Lucia Istituto Di Ricovero e Cura a Carattere Scientifico, Rome, IT.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Macchiusi', 'Affiliation': 'Laboratory of Neuropsychiatry, Fondazione Santa Lucia Istituto Di Ricovero e Cura a Carattere Scientifico, Rome, IT.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Assogna', 'Affiliation': 'Laboratory of Neuropsychiatry, Fondazione Santa Lucia Istituto Di Ricovero e Cura a Carattere Scientifico, Rome, IT.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Spalletta', 'Affiliation': 'Laboratory of Neuropsychiatry, Fondazione Santa Lucia Istituto Di Ricovero e Cura a Carattere Scientifico, Rome, IT.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gage', 'Affiliation': 'Surrey Health Economics Centre, Department of Clinical and Experimental Medicine, University of Surrey, Guildford, GB.'}, {'ForeName': 'Morro', 'Initials': 'M', 'LastName': 'Touray', 'Affiliation': 'Surrey Health Economics Centre, Department of Clinical and Experimental Medicine, University of Surrey, Guildford, GB.'}, {'ForeName': 'Lada', 'Initials': 'L', 'LastName': 'Timotijevic', 'Affiliation': 'School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, GB.'}, {'ForeName': 'Charo', 'Initials': 'C', 'LastName': 'Hodgkins', 'Affiliation': 'School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, GB.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Chondrogiorgi', 'Affiliation': 'Department of Neurology, Medical School, University of Ioannina, University Campus of Ioannina, Ioannina, GR.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Rigas', 'Affiliation': 'Unit of Medical Technology and Intelligent Information System, Department of Materials Science and Engineering, University of Ioannina, Ioannina, GR.'}, {'ForeName': 'Dimitrios I', 'Initials': 'DI', 'LastName': 'Fotiadis', 'Affiliation': 'Unit of Medical Technology and Intelligent Information System, Department of Materials Science and Engineering, University of Ioannina, Ioannina, GR.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Konitsiotis', 'Affiliation': 'Department of Neurology, Medical School, University of Ioannina, University Campus of Ioannina, Ioannina, GR.'}]",JMIR mHealth and uHealth,['10.2196/16414']
3206,32442189,Safety and continued use of the levonorgestrel intrauterine system as compared with the copper intrauterine device among women living with HIV in South Africa: A randomized controlled trial.,"BACKGROUND


Women living with HIV (WLHIV) have lower rates of contraceptive use than noninfected peers, yet concerns regarding contraceptive efficacy and interaction with antiretroviral therapy (ART) complicate counseling. Hormonal contraceptives may increase genital tract HIV viral load (gVL) and sexual transmission risk to male partners. We compared gVL, plasma VL (pVL), and intrauterine contraceptive (IUC) continuation between the levonorgestrel intrauterine system (LNG-IUS) and copper intrauterine device (C-IUD) in Cape Town, South Africa.
METHODS AND FINDINGS


In this double-masked, randomized controlled noninferiority trial, eligible WLHIV were ages 18-40, not pregnant or desiring pregnancy within 30 months, screened and treated (as indicated) for reproductive tract infections (RTIs) within 1 month of enrollment, and virologically suppressed using ART or above treatment threshold at enrollment (non-ART). Between October 2013, and December 2016, we randomized consenting women within ART groups, using 1:1 permuted block randomization stratified by ART use, age (18-23, 24-31, 32-40), and recent injectable progestin contraceptive (IPC) exposure, and provided the allocated IUC. At all visits, participants provided specimens for gVL (primary outcome), pVL, RTI, and pregnancy testing. We assessed gVL and pVL across 6 and 24 months controlling for enrollment measures, ART group, age, and RTI using generalized estimating equation and generalized linear models (non-ART group pVL and hemoglobin) in as-treated analyses. We measured IUC discontinuation rates with Kaplan-Meier estimates and Cox proportional hazards models. We enrolled 71 non-ART (36 LNG-IUS, 31 C-IUD; 2 declined and 2 were ineligible) and 134 ART-using (65 LNG-IUS, 67 C-IUD; 1 declined and 1 could not complete IUC insertion) women. Participant median age was 31 years, and 95% had 1 or more prior pregnancies. Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88). Among ART users, proportions with detectable pVL were not significantly different at 6 (AOR = 0.83, 95% CI 0.37-1.86, p = 0.65) and 24 months (AOR = 0.94, 95% CI 0.49-1.81, p = 0.85), whereas among non-ART women, mean pVL was not significantly different at 6 months (-0.10 log10 copies/mL, 95% CI -0.29 to 0.10, p = 0.50) between LNG-IUS and C-IUD users. IUC continuation was 78% overall; C-IUD users experienced significantly higher expulsion (8% versus 1%, p = 0.02) and elective discontinuation (adjusted hazard ratio: 8.75, 95% CI 3.08-24.8, p < 0.001) rates. Sensitivity analysis adjusted for differential IUC discontinuation found similar gVL results. There were 39 serious adverse events (SAEs); SAEs believed to be directly related to IUC use (n = 7) comprised 3 pelvic inflammatory disease (PID) cases and 4 pregnancies with IUC in place with no discernible trend by IUC arm. Mean hemoglobin change was significantly higher among LNG-IUS users across 6 (0.57 g/dL, 95% CI 0.24-0.90; p < 0.001) and 24 months (0.71 g/dL, 95% CI 0.47-0.95; p < 0.001). Limitations included not achieving non-ART group sample size following change in ART treatment guidelines and truncated 24 months' outcome data, as 17 women were not yet eligible for their 24-month visit at study closure. Also, a change in VL assay during the study may have caused some discrepancy in VL values because of different limits of detection.
CONCLUSIONS


In this study, we found that the LNG-IUS did not increase gVL or pVL and had low levels of contraceptive failure and associated PID compared with the C-IUD among WLHIV. LNG-IUS users were significantly more likely to continue IUC use and had higher hemoglobin levels over time. The LNG-IUS appears to be a safe contraceptive with regard to HIV disease and may be a highly acceptable option for WLHIV.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01721798.",2020,"Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88).","['women living with HIV in South Africa', 'Participant median age was 31 years, and 95% had 1 or more prior pregnancies', 'male partners', 'We enrolled 71 non-ART (36 LNG-IUS, 31 C-IUD; 2 declined and 2 were ineligible) and 134 ART-using (65 LNG-IUS, 67 C-IUD; 1 declined and 1 could not complete IUC insertion) women', 'Cape Town, South Africa', 'eligible WLHIV were ages 18-40, not pregnant or desiring pregnancy within 30 months, screened and treated (as indicated) for reproductive tract infections (RTIs) within 1 month of enrollment, and virologically suppressed using ART or above treatment threshold at enrollment (non-ART', 'Between October 2013, and December 2016, we randomized consenting women within ART groups, using 1:1 permuted block randomization stratified by ART use, age (18-23, 24-31, 32-40), and recent', 'Women living with HIV (WLHIV']","['Hormonal contraceptives', 'levonorgestrel intrauterine system', 'injectable progestin contraceptive (IPC) exposure, and provided the allocated IUC', 'levonorgestrel intrauterine system (LNG-IUS) and copper intrauterine device (C-IUD']","['39 serious adverse events (SAEs); SAEs', 'gVL or pVL and had low levels of contraceptive failure and associated PID', 'Mean hemoglobin change', 'elective discontinuation', 'hemoglobin levels', 'pVL, RTI, and pregnancy testing', 'genital tract HIV viral load (gVL) and sexual transmission risk', 'mean pVL', 'gVL, plasma VL (pVL), and intrauterine contraceptive (IUC) continuation', 'expulsion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1444661', 'cui_str': 'Stopped before completion'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C2314882', 'cui_str': 'Genital Tract Infections'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009866', 'cui_str': 'Contraception failure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031406', 'cui_str': 'Phenindione'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}, {'cui': 'C1519279', 'cui_str': 'Sexual transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3653534', 'cui_str': 'Intrauterine contraceptives'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}]",71.0,0.642316,"Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44-1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68-1.57, p = 0.88).","[{'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Todd', 'Affiliation': 'Maternal and Child Health and Nutrition Department, Global Health, Population, and Nutrition, Durham, North Carolina, United States of America.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology and Biostatistics, City University of New York School of Public Health, New York, New York, United States of America.'}, {'ForeName': 'Nontokozo', 'Initials': 'N', 'LastName': 'Langwenya', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Observatory, Cape Town, South Africa.'}, {'ForeName': 'Donald R', 'Initials': 'DR', 'LastName': 'Hoover', 'Affiliation': 'Department of Statistics and Institute for Health Care Policy and Aging Research, Rutgers University, Piscataway, New Jersey, United States of America.'}, {'ForeName': 'Pai-Lien', 'Initials': 'PL', 'LastName': 'Chen', 'Affiliation': 'Global Population and Health Research Department, Global Health, Population, and Nutrition, Durham, North Carolina, United States of America.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Petro', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Cape Town, Observatory, Cape Town, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Observatory, Cape Town, South Africa.'}]",PLoS medicine,['10.1371/journal.pmed.1003110']
3207,32443290,Total and hidden blood loss between open posterior lumbar interbody fusion and transforaminal lumbar interbody fusion by Wiltse approach.,"The purpose of this study was to calculate and compare the volume of hidden blood loss (HBL) and perioperative blood loss between open posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) by Wiltse approach.We retrospectively analyzed 143 patients between March 2017 and December 2017, they were randomly divided into PLIF group and TLIF group. The following information were collected on admission: patient's age, gender, height, weight, body mass index (BMI), surgery levels, surgical time, duration time, disorder type, intraoperative bleeding, wound drainage, visual analog scale (VAS) scores, neurological complications, transfusion rate. Preoperative and postoperative hematocrit (Hct) were recorded in order to calculate total blood loss (TBL) according to Gross's formula. To calculate each patient's HBL, chi-square test and Student's t test were used to analyze data.Patients in PLIF had a mean TBL of 1144 ± 356 mL, and the mean HBL was 486 ± 203 mL, 43.9 ± 16.2% of the TBL. While patients in TLIF, the mean TBL was 952 ± 303 mL, and the mean HBL was 421 ± 178 mL, 44.7 ± 17.0% of the TBL. Hence, there was significant difference in TBL and HBL between 2 groups, respectively (P = .000, P = .044). However, there was no difference in the ratio of the HBL between 2 groups (P = .797).The volume of HBL is lower in open TLIF by Wiltse approach than that in PLIF, which may be a large proportion of TBL in posterior lumbar fusion surgery. Comprehensive understanding of HBL can contribute to keep patient safety and better to rehabilitation in perioperative.",2020,"However, there was no difference in the ratio of the HBL between 2 groups (P = .797).The",['143 patients between March 2017 and December 2017'],"['open posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF', 'PLIF group and TLIF']","['ratio of the HBL', 'weight, body mass index (BMI), surgery levels, surgical time, duration time, disorder type, intraoperative bleeding, wound drainage, visual analog scale (VAS) scores, neurological complications, transfusion rate', 'Preoperative and postoperative hematocrit (Hct', 'TBL and HBL', 'Total and hidden blood loss', 'volume of hidden blood loss (HBL) and perioperative blood loss', 'volume of HBL', 'total blood loss (TBL']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0406834', 'cui_str': 'Wound discharge finding'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205262', 'cui_str': 'Occult'}]",143.0,0.0228292,"However, there was no difference in the ratio of the HBL between 2 groups (P = .797).The","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Lei', 'Affiliation': 'Department of Spine Surgery, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St., Luzhou 646000.'}, {'ForeName': 'Zhongyang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics Surgery, West China Hospital, Sichuan University, No. 37 Guoxue St. of Wuhou District, Chengdu 610041.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Library, Southwest Medical University, No. 1 Xianglin Road of Longma District, Luzhou 646000, Sichuan, China.'}, {'ForeName': 'Xinggui', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Spine Surgery, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St., Luzhou 646000.'}, {'ForeName': 'Lipeng', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Department of Spine Surgery, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St., Luzhou 646000.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Department of Spine Surgery, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St., Luzhou 646000.'}, {'ForeName': 'Daxiong', 'Initials': 'D', 'LastName': 'Feng', 'Affiliation': 'Department of Spine Surgery, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St., Luzhou 646000.'}]",Medicine,['10.1097/MD.0000000000019864']
3208,32443302,Analgesia for spinal anesthesia positioning in elderly patients with proximal femoral fractures: Dexmedetomidine-ketamine versus dexmedetomidine-fentanyl.,"Elderly patients with femoral fractures are anticipated to endure the most pain caused by positional changes required for spinal anesthesia. To improve pain relief, we compared the analgesic effects of intravenous dexmedetomidine-ketamine and dexmedetomidine-fentanyl combinations to facilitate patient positioning for spinal anesthesia in elderly patients with proximal femoral fractures. Forty-six patients were randomly assigned to two groups and received either 1 mg/kg of intravenous ketamine (group K) or 1 μg/kg of intravenous fentanyl (group F) concomitant with a loading dose of dexmedetomidine 1 μg/kg over 10 minutes, then dexmedetomidine infusion only was continued at 0.6 μg/kg/h for following 20 minutes, and titrated at a rate of 0.2 to 0.6 μg/kg/h until the end of surgery. After completion of the infusion of either ketamine or fentanyl, the patients were placed in the lateral position with the fracture site up. The pain score (0 = calm, 1 = facial grimacing, 2 = moaning, 3 = screaming, and 4 = unable to proceed because of restlessness or agitation) was used to describe the pain intensity in each step during the procedure (lateral positioning, hip flexion, and lumbar puncture), and quality score (0 = poor hip flexion, 1 = satisfactory hip flexion, 2 = good hip flexion, and 3 = optimal hip flexion) was used to describe the quality of posture. Group K showed a median pain score of 0 (0-1), 0 (0-0) and 0 (0-0) in lateral positioning, hip flexion and lumbar puncture, respectively, while group F showed a score of 3 (2.75-3), 3 (2-3) and 0 (0-1), respectively. The pain score in lateral positioning (P < .0001) and hip flexion (P < .0001) was significantly lower in group K than group F. Group K showed the significantly higher quality scores of spinal anesthesia positioning (P = .0044) than group F. Hemodynamic adverse effects, such as bradycardia, hypotension, and desaturation, were not significantly different between the groups. The administration of dexmedetomidine-ketamine showed a greater advantage in reducing pain intensity and increasing the quality with patient positioning during spinal anesthesia in elderly patients with proximal femoral fractures, without any serious adverse effects.",2020,"The pain score in lateral positioning (P < .0001) and hip flexion (P < .0001) was significantly lower in group K than group F. Group K showed the significantly higher quality scores of spinal anesthesia positioning (P = .0044) than group F. Hemodynamic adverse effects, such as bradycardia, hypotension, and desaturation, were not significantly different between the groups.","['elderly patients with proximal femoral fractures', 'Elderly patients with femoral fractures', 'Forty-six patients']","['dexmedetomidine-fentanyl combinations', 'dexmedetomidine-ketamine', 'Dexmedetomidine-ketamine', 'Analgesia', 'dexmedetomidine-fentanyl', 'fentanyl (group F) concomitant with a loading dose of dexmedetomidine', 'intravenous ketamine', 'ketamine or fentanyl', 'dexmedetomidine']","['median pain score', 'pain relief', 'hip flexion', 'quality scores of spinal anesthesia positioning', 'pain intensity', 'pain score in lateral positioning', 'pain score', 'bradycardia, hypotension, and desaturation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0441840', 'cui_str': 'Group F'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}]",46.0,0.0817178,"The pain score in lateral positioning (P < .0001) and hip flexion (P < .0001) was significantly lower in group K than group F. Group K showed the significantly higher quality scores of spinal anesthesia positioning (P = .0044) than group F. Hemodynamic adverse effects, such as bradycardia, hypotension, and desaturation, were not significantly different between the groups.","[{'ForeName': 'Ki Hwa', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Inje University Haeundae Paik Hospital, Haeundaegu, Busan, Republic of Korea.'}, {'ForeName': 'Soo Jee', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jae Hong', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Se Hun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hyunseong', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Dae Seok', 'Initials': 'DS', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'Yong Han', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Yei Heum', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hyojoong', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sang Eun', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020001']
3209,32443306,Prospective randomized controlled trial study of Luofengning granule in the treatment of unstable angina.,"INTRODUCTION


Although the current western treatment plans for unstable angina (UA) has been optimized in past decades, UA still is a common phenotype of acute coronary syndrome and significantly influence the quality of life and endanger lives. In China, the clinical application of Chinese herb medicine is considered as an effective approach to treating UA and widely recognized by patients. In clinical practices, we found Luofengning granule (LFN-G) could improve clinical manifestations of patients with UA, but there is lack of rigorous proof of evidence-based medicine. This trial aims to further evaluate the efficacy of LFN-G in the treatment of UA.
METHODS


A prospective, open-label, randomized, placebo-controlled clinical will be performed. A total of 60 patients diagnosed with UA will be randomly allocated to either the treatment group or the control group with a 1:1 ratio. The participants in the treatment group will receive LFN-G treatment and the participants in the control group will receive placebo. Meanwhile, both groups continue to undergo standard western medicine treatments. The duration of interventions is 4 weeks. The primary endpoint is the incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death. Secondary outcomes include Seattle angina scale score, Chinese medicine syndromes and electrocardiograph (at weeks 0, 1, 2, 4), myocardial nuclides perfusion, measurement of wall motion score index and left ventricular ejection fraction, serum inflammation factors such as C-reactive protein, high sensitive-C-reactive protein, interleukin-6, matrix metalloproteinase-9, and so on (at weeks 0, 4). In addition, some biochemical indexes of blood and hematological indexes will be used to assess the safety of treatments. Any adverse effects of the treatment will be recorded.
DISCUSSION


The results of this trial will provide compelling evidence of the efficacy and safety of LFN-G for treatment of UA and preliminarily reveal the potential mechanism of how LFN-G acts. Finally, it will widen treatment options for patients with UA.",2020,"The primary endpoint is the incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death.","['unstable angina', '60 patients diagnosed with UA', 'patients with UA']","['Luofengning granule', 'LFN-G treatment', 'LFN-G', 'placebo']","['Seattle angina scale score, Chinese medicine syndromes and electrocardiograph (at weeks 0, 1, 2, 4), myocardial nuclides perfusion, measurement of wall motion score index and left ventricular ejection fraction, serum inflammation factors such as C-reactive protein, high sensitive-C-reactive protein, interleukin-6, matrix metalloproteinase-9, and so on (at weeks 0, 4', 'incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death']","[{'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4324428', 'cui_str': 'Wall motion score index'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}]",60.0,0.0824664,"The primary endpoint is the incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death.","[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Jun-Jun', 'Initials': 'JJ', 'LastName': 'Cai', 'Affiliation': 'Department of Hepatology, Tianjin Third Central Hospital, Tianjin.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}, {'ForeName': 'Lei-Lei', 'Initials': 'LL', 'LastName': 'Liu', 'Affiliation': 'School of Traditional Chinese Medicine.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'School of Life Science.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing.'}]",Medicine,['10.1097/MD.0000000000020025']
3210,32443319,Evaluation and ultrastructural changes of amniotic membrane fragility after UVA/riboflavin cross-linking and its effects on biodegradation.,"This study aims to evaluate the changes of fragility and ultrastructure of amniotic membrane after cross-linking by UVA/riboflavin.Forty-nine fresh amniotic membranes were randomly divided into 3 groups. Eighteen were in group A (CX group) and immersed in 0.1% riboflavin solution for 10 min for UVA/riboflavin cross-linking. Sixteen were in group B (B2 group), soaked for 10 min with 0.1% riboflavin. After soaking, membranes in group A and B were transferred into corneal preservation solution. Fifteen pieces were in group C, directly into corneal preservation solution. The biomechanical and ultrastructural changes of the amniotic tissue before and after cross-linking were examined (CX group = 13, B2 group = 11, C group = 15). The amniotic membrane tissue of group A (n = 5) and B (n = 5) was transplanted into 16 eyes of the rabbits, respectively, and the dissolution time of the amniotic membrane tissue was investigated.After cross-linking, compared with the control group, the elastic modulus of the low-stress area of the amniotic membrane (Elow) was higher, while the elastic modulus of the high-stress area of the amniotic membrane (Ehigh) was lower, with no significant difference in the tensile strength. Also, the collagen fibers showed coarse and bamboo-like changes. In group A, amniotic membranes began to dissolve 4 weeks after conjunctiva transplantation, and all amniotic membranes were dissolved and absorbed 6 weeks after conjunctiva transplantation. In group B, some amniotic membrane tissues were still visible 6 weeks after conjunctiva transplantation.This study suggested that after amniotic membrane cross-linking, the brittleness was increased, the hardness was enhanced, and the morphology of the collagen fiber was changed. The cross-linked amniotic membrane showed resistance to tissue dissolution.",2020,"After cross-linking, compared with the control group, the elastic modulus of the low-stress area of the amniotic membrane (Elow) was higher, while the elastic modulus of the high-stress area of the amniotic membrane (Ehigh) was lower, with no significant difference in the tensile strength.",['Forty-nine fresh amniotic membranes'],"['UVA/riboflavin', 'soaked for 10\u200amin with 0.1% riboflavin', 'riboflavin solution for 10\u200amin for UVA/riboflavin']","['tensile strength', 'elastic modulus of the low-stress area of the amniotic membrane (Elow', 'fragility and ultrastructure of amniotic membrane', 'amniotic membrane tissues']","[{'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}]","[{'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C1540845', 'cui_str': 'Tensile strength'}, {'cui': 'C2350289', 'cui_str': 'Young Modulus'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0302113', 'cui_str': 'Fragility'}, {'cui': 'C0041623', 'cui_str': 'ultrastructure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",15.0,0.0229728,"After cross-linking, compared with the control group, the elastic modulus of the low-stress area of the amniotic membrane (Elow) was higher, while the elastic modulus of the high-stress area of the amniotic membrane (Ehigh) was lower, with no significant difference in the tensile strength.","[{'ForeName': 'Chenming', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Jinan Second People's Hospital.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': ""Jinan Second People's Hospital.""}, {'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Mu', 'Affiliation': 'Shandong Provincial Hospital, Jinan.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shandong Provincial Hospital, Jinan.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Jinan Second People's Hospital.""}, {'ForeName': 'Fumin', 'Initials': 'F', 'LastName': 'Long', 'Affiliation': ""People's Hospital of Taierzhuang District, Zaozhuang, China.""}, {'ForeName': 'Qiaoling', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Jinan Second People's Hospital.""}]",Medicine,['10.1097/MD.0000000000020091']
3211,32443412,Micronutrient and Inflammation Status Following One Year of Complementary Food Supplementation in 18-Month-Old Rural Bangladeshi Children: A Randomized Controlled Trial.,"Background:  Four fortified complementary food supplements (CFSs) in a randomized controlled trial (RCT) were found to improve childhood linear growth in rural Bangladesh. We hypothesized children receiving these supplements would have improved micronutrient status.  Methods:  In the RCT, we assessed hemoglobin and serum ferritin, retinol, zinc, C-reactive protein (CRP), and α-1-acid glycoprotein (AGP) at endline (18 mo) in a subsample of children ( n  = 752). The impact of supplementation on mean concentrations and the prevalence of nutrient deficiency and inflammation were evaluated using adjusted generalized estimating equation (GEE) linear and log-binomial regression models.  Results:  In the control arm at age 18 months, 13% of children were anemic (hemoglobin < 110 g/L), and 6% were iron (inflammation-adjusted ferritin < 12 μg/L), 8% vitamin A (inflammation-adjusted retinol < 0.70 μmol/L), and 5% zinc (zinc < 9.9 μmol/L) deficient. The prevalence of inflammation by CRP (>5 mg/L) and AGP (>1 g/L) was 23% and 66%, respectively, in the control group. AGP trended lower in CFS groups ( p  = 0.04), while CRP did not. Mean ferritin ( p  < 0.001) and retinol ( p  = 0.007) were higher in all supplemented groups relative to control, whereas hemoglobin improved with two of the four CFSs ( p  = 0.001), and zinc was equal or lower in supplemented groups relative to control ( p  = 0.017).  Conclusions:  CFSs improved iron status and vitamin A concentrations and lowered inflammation in a context of low underlying nutrient deficiency but high inflammation.",2020,"Mean ferritin ( p  < 0.001) and retinol ( p  = 0.007) were higher in all supplemented groups relative to control, whereas hemoglobin improved with two of the four CFSs ( p  = 0.001), and zinc was equal or lower in supplemented groups relative to control ( p  = 0.017).  ","['rural Bangladesh', '18-Month-Old Rural Bangladeshi Children']","['fortified complementary food supplements (CFSs', 'Complementary Food Supplementation']","['AGP', 'Micronutrient and Inflammation Status', 'hemoglobin and serum ferritin, retinol, zinc, C-reactive protein (CRP), and α-1-acid glycoprotein (AGP', 'mean concentrations and the prevalence of nutrient deficiency and inflammation', 'Mean ferritin', 'hemoglobin', 'prevalence of inflammation by CRP']","[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0029297', 'cui_str': 'Alpha-1- acid glycoprotein'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}]",,0.152667,"Mean ferritin ( p  < 0.001) and retinol ( p  = 0.007) were higher in all supplemented groups relative to control, whereas hemoglobin improved with two of the four CFSs ( p  = 0.001), and zinc was equal or lower in supplemented groups relative to control ( p  = 0.017).  ","[{'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Campbell', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Saijuddin', 'Initials': 'S', 'LastName': 'Shaikh', 'Affiliation': 'JiVitA Project, Gaibandha-5700, Bangladesh.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Schulze', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Margia', 'Initials': 'M', 'LastName': 'Arguello', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Hasmot', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'JiVitA Project, Gaibandha-5700, Bangladesh.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'West', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Christian', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205, USA.'}]",Nutrients,['10.3390/nu12051452']
3212,32443433,The Effects on Immune Function and Digestive Health of Consuming the Skin and Flesh of Zespri ®  SunGold Kiwifruit ( Actinidia Chinensis  var.  Chinensis  'Zesy002') in Healthy and IBS-Constipated Individuals.,"Irritable bowel syndrome (IBS) is a common gastrointestinal disorder that results in constipation (IBS-C) or diarrhoea with abdominal pain, flatulence, nausea and bloating. Kiwifruit ( Actinidia  spp.) are nutrient-dense fruit with a number of reported health benefits that include lowering glycaemic response, improving cardiovascular and inflammatory biomarkers, and enhancing gut comfort and laxation. This study investigated the effect of consuming three whole Zespri ®  SunGold kiwifruit ( Actinidia chinensis  var.  chinensis  'Zesy002') with or without skin on cytokine production and immune and gut health in healthy people and those with IBS-C symptoms. This study enrolled thirty-eight participants in a 16 week randomized cross-over study (19 healthy and 19 participants with IBS-C). Participants were randomized to consume either three kiwifruit without eating the skin or three kiwifruit including the skin for 4 weeks each, with a 4 week washout in between each intervention. There was a significant decrease in the pro-inflammatory cytokine, TNF-α, for both the healthy and the IBS-C participants when they consumed whole kiwifruit and skin, and also for the healthy participants when they ate whole kiwifruit without the skin ( p  < 0.001). The kiwifruit interventions increased bowel frequency and significantly reduced the gastrointestinal symptom rating scale constipation and Birmingham IBS pain scores for both participant groups. We have demonstrated that consuming the skin of SunGold kiwifruit might have beneficial effects on gastrointestinal health that are not produced by consuming the flesh alone.",2020,"There was a significant decrease in the pro-inflammatory cytokine, TNF-α, for both the healthy and the IBS-C participants when they consumed whole kiwifruit and skin, and also for the healthy participants when they ate whole kiwifruit without the skin ( p  < 0.001).","['Healthy and IBS-Constipated Individuals', 'healthy people and those with IBS-C symptoms', 'enrolled thirty-eight participants in a 16 week randomized cross-over study (19 healthy and 19 participants with IBS-C']","['kiwifruit without eating the skin or three kiwifruit including the skin', 'consuming three whole Zespri ®  SunGold kiwifruit ( Actinidia chinensis  var']","['Irritable bowel syndrome (IBS', 'pro-inflammatory cytokine, TNF-α', 'gastrointestinal symptom rating scale constipation and Birmingham IBS pain scores', 'cytokine production and immune and gut health', 'bowel frequency']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0971874', 'cui_str': 'Actinidia deliciosa'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0949891', 'cui_str': 'Kiwi Plant'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",38.0,0.0379497,"There was a significant decrease in the pro-inflammatory cytokine, TNF-α, for both the healthy and the IBS-C participants when they consumed whole kiwifruit and skin, and also for the healthy participants when they ate whole kiwifruit without the skin ( p  < 0.001).","[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Eady', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 4704, Lincoln 7608, New Zealand.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Wallace', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 4704, Lincoln 7608, New Zealand.'}, {'ForeName': 'Duncan I', 'Initials': 'DI', 'LastName': 'Hedderley', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 11600, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Bentley-Hewitt', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 11600, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Butts', 'Affiliation': 'The New Zealand Institute for Plant and Food Research Limited, Private Bag 11600, Palmerston North 4442, New Zealand.'}]",Nutrients,['10.3390/nu12051453']
3213,32443684,Early Effect of Supplemented Infant Formulae on Intestinal Biomarkers and Microbiota: A Randomized Clinical Trial.,"BACKGROUND


Post-natal gut maturation in infants interrelates maturation of the morphology, digestive, and immunological functions and gut microbiota development. Here, we explored both microbiota development and markers of gut barrier and maturation in healthy term infants during their early life to assess the interconnection of gut functions during different infant formulae regimes.
METHODS


A total of 203 infants were enrolled in this randomized double-blind controlled trial including a breastfed reference group. Infants were fed starter formulae for the first four weeks of life, supplemented with different combination of nutrients (lactoferrin, probiotics ( Bifidobacterium animal  subsp.  Lactis ) and prebiotics (Bovine Milk-derived Oligosaccharides-BMOS)) and subsequently fed the control formula up to eight weeks of life. Stool microbiota profiles and biomarkers of early gut maturation, calprotectin (primary outcome), elastase, α-1 antitrypsin (AAT) and neopterin were measured in feces at one, two, four, and eight weeks.
RESULTS


Infants fed formula containing BMOS had lower mean calprotectin levels over the first two to four weeks compared to the other formula groups. Elastase and AAT levels were closer to levels observed in breastfed infants. No differences were observed for neopterin. Global differences between the bacterial communities of all groups were assessed by constrained multivariate analysis with hypothesis testing. The canonical correspondence analysis (CCA) at genus level showed overlap between microbiota profiles at one and four weeks of age in the BMOS supplemented formula group with the breastfed reference, dominated by bifidobacteria. Microbiota profiles of all groups at four weeks were significantly associated with the calprotectin levels at 4 (CCA,  p  = 0.018) and eight weeks of age (CCA,  p  = 0.026).
CONCLUSION


A meaningful correlation was observed between changes in microbiota composition and gut maturation marker calprotectin. The supplementation with BMOS seems to favor gut maturation closer to that of breastfed infants.",2020,"RESULTS


Infants fed formula containing BMOS had lower mean calprotectin levels over the first two to four weeks compared to the other formula groups.","['healthy term infants', 'A total of 203 infants']","['nutrients (lactoferrin, probiotics ( Bifidobacterium animal  subsp', 'Supplemented Infant Formulae', 'prebiotics (Bovine Milk-derived Oligosaccharides-BMOS']","['microbiota composition and gut maturation marker calprotectin', 'Stool microbiota profiles and biomarkers of early gut maturation, calprotectin (primary outcome), elastase, α-1 antitrypsin (AAT) and neopterin', 'Intestinal Biomarkers and Microbiota', 'neopterin', 'calprotectin levels', 'mean calprotectin levels', 'Elastase and AAT levels', 'Microbiota profiles']","[{'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030306', 'cui_str': 'Pancreatic elastase'}, {'cui': 'C2713669', 'cui_str': 'SERPINA5 protein, human'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0052586', 'cui_str': 'ATA protocol'}]",203.0,0.0733011,"RESULTS


Infants fed formula containing BMOS had lower mean calprotectin levels over the first two to four weeks compared to the other formula groups.","[{'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Castanet', 'Affiliation': 'CIC INSERM U1404, Department of Pediatric, Rouen University Hospital Charles Nicolle, 76031 Rouen, France.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Costalos', 'Affiliation': 'Department of Neonatology, Alexandra Regional General Hospital, 11528 Athens, Greece.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Haiden', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Hascoet', 'Affiliation': 'Department of Neonatology, Maternite Regionale, CHRU Nancy, 54035 Nancy, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Berger', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Sprenger', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Grathwohl', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Brüssow', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'De Groot', 'Affiliation': 'SBU Nutrition, Nestlé, 1800 Vevey, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Steenhout', 'Affiliation': 'Nestlé Health Science, 1066 Epalinges, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pecquet', 'Affiliation': 'SBU Nutrition, Nestlé, 1800 Vevey, Switzerland.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Benyacoub', 'Affiliation': 'Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Picaud', 'Affiliation': 'Department of Neonatology, University Hospital Croix Rousse, Hospices Civils de Lyon, 69317 Lyon France.'}]",Nutrients,['10.3390/nu12051481']
3214,32444041,The effect of vitamin C supplementation in the last month of pregnancy on neonatal bilirubin levels; A double-blind randomized clinical trial.,"OBJECTIVES


Jaundice is a typical condition in the neonatal period, particularly in the Asian continent. Drowsiness and disruption of breastfeeding, behavioral and neurological disorders, hearing loss and mental retardation are the results of impairment in controlling it. The increase in oxidant substances can stimulate the heme oxygenase enzyme and increase the conversion of heme to bilirubin. In some studies, vitamin C levels in the blood of infants with hyperbilirubinemia were lower than in healthy infants.
DESIGN


In this double-blind clinical trial study, 144 healthy pregnant women aged 20-40 years who were in 34th weeks of gestation were randomly divided into intervention, and control groups and until the end of pregnancy, they took a 500 mg tablet of vitamin C or placebo (Preparation of starch) daily. Demographic information, dietary intake, and physical activity level of the participants were also evaluated. The total blood bilirubin level was measured on the fifth day after birth using a sample of the neonatal heel. Statistical analysis was performed using SPSS software version 22. In this study P-value < 0. 05 was considered significant.
RESULTS


Of the 144 participants, 128 of them completed the intervention. There was no significant difference between the two groups at the level of vitamin C intake through diet, and anthropometric indices, but the total bilirubin level in the neonates of the two groups was statistically different (P = 0.02).
CONCLUSION


Vitamin C supplementation in the last month of pregnancy had a significant effect on neonatal bilirubin level and decreased it significantly.",2020,"There was no significant difference between the two groups at the level of vitamin C intake through diet, and anthropometric indices, but the total bilirubin level in the neonates of the two groups was statistically different (P = 0.02).
","['144 participants', '144 healthy pregnant women aged 20-40 years who were in 34th weeks of gestation']","['vitamin C or placebo (Preparation of starch) daily', 'Vitamin C supplementation', 'vitamin C supplementation']","['Drowsiness and disruption of breastfeeding, behavioral and neurological disorders, hearing loss and mental retardation', 'total blood bilirubin level', 'neonatal bilirubin level', 'Demographic information, dietary intake, and physical activity level', 'vitamin C levels', 'neonatal bilirubin levels', 'conversion of heme to bilirubin', 'level of vitamin C intake through diet, and anthropometric indices', 'oxidant substances', 'total bilirubin level']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0020796', 'cui_str': 'Profound intellectual disability'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0863174', 'cui_str': 'Blood bilirubin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0018966', 'cui_str': 'Heme'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0564420', 'cui_str': 'Vitamin C intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement'}]",144.0,0.122377,"There was no significant difference between the two groups at the level of vitamin C intake through diet, and anthropometric indices, but the total bilirubin level in the neonates of the two groups was statistically different (P = 0.02).
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Khadem Al-Hosseini', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Rahideh', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saadati', 'Affiliation': 'Pediatric Research Center, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Rahmati', 'Affiliation': 'Department of Obstetrics and Gynecology, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Azadeh', 'Affiliation': 'Health Deputy, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Shidfar', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: shidfar.f@iums.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102359']
3215,32444045,The effect of the Mediterranean diet on cognitive function in patients with Parkinson's disease: A randomized clinical controlled trial.,"OBJECTIVES


Parkinson's disease (PD) is the second most common neurodegenerative disorder. It is proposed that adherence to the Mediterranean diet might have a beneficial effect on the prevention and treatment of PD and its complications. Thus, the aim of this study was to investigate the effects of the Mediterranean diet on cognitive function in patients with PD.
DESIGN


The study was a single-center, randomized clinical trial. Eighty patients with idiopathic PD were randomly allocated to the Mediterranean diet (n = 40) or control (n = 40) group. Patients in the intervention group received an individualized dietary plan based on Mediterranean diet for 10 weeks. The Persian version of Montreal Cognitive Assessment (MoCA) test was used to assess the cognitive function at baseline and the end of the study.
RESULTS


Thirty-five PD patients with a mean age of 59.3 ± 8.3 and 35 patients with a mean age of 58.6 ± 9.3 finished the study in intervention and control groups, respectively. After the intervention, the mean score of the dimensions of executive function, language, attention, concentration, and active memory and the total score of cognitive assessment significantly increased in the intervention compared with the control group (p < 0.05, for all). Nevertheless, the mean of the other scores including spatial-visual ability, memory learning task, and navigation versus time and place did not significantly change in both intervention and control groups.
CONCLUSIONS


The findings of this study showed that adherence to the Mediterranean diet remarkably increased the dimensions of executive function, language, attention, concentration, and active memory and finally the total score of cognitive assessment in PD patients.",2020,"After the intervention, the mean score of the dimensions of executive function, language, attention, concentration, and active memory and the total score of cognitive assessment significantly increased in the intervention compared with the control group (p < 0.05, for all).","[""patients with Parkinson's disease"", 'Eighty patients with idiopathic PD', 'patients with PD', ""Parkinson's disease (PD"", 'Thirty-five PD patients with a mean age of 59.3\u202f±\u202f8.3 and 35 patients with a mean age of 58.6\u202f±']","['individualized dietary plan based on Mediterranean diet', 'Mediterranean diet']","['Persian version of Montreal Cognitive Assessment (MoCA) test', 'cognitive function', 'dimensions of executive function, language, attention, concentration, and active memory and finally the total score of cognitive assessment', 'mean score of the dimensions of executive function, language, attention, concentration, and active memory and the total score of cognitive assessment', 'spatial-visual ability, memory learning task, and navigation versus time and place']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}]","[{'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442504', 'cui_str': 'Place'}]",80.0,0.0280924,"After the intervention, the mean score of the dimensions of executive function, language, attention, concentration, and active memory and the total score of cognitive assessment significantly increased in the intervention compared with the control group (p < 0.05, for all).","[{'ForeName': 'Zamzam', 'Initials': 'Z', 'LastName': 'Paknahad', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: paknahad@hlth.mui.ac.ir.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Sheklabadi', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Yeganeh', 'Initials': 'Y', 'LastName': 'Derakhshan', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bagherniya', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Chitsaz', 'Affiliation': 'Professor of Neurology Isfahan University of Medical Sciences, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102366']
3216,32444056,"The effects of licorice containing diphenhydramine solution on recurrent aphthous stomatitis: A double-blind, randomized clinical trial.","OBJECTIVES


The aim of this study was to compare the efficacy of the diphenhydramine solution (DS) and diphenhydramine-containing glycyrrhiza glabra (DSG) in the treatment of recurrent aphthous stomatitis (RAS).
DESIGN


It was a double-blind randomized clinical trial that was conducted from July to September 2018 at the Faculty of Dentistry, Birjand University of Medical Sciences, Birjand, Iran.
INTERVENTION


DSG was made by adding 5% hydroethanolic extract of licorice to the diphenhydramine elixir. A total of 70 patients diagnosed with RSA were randomly assigned to the DS and DSG groups, each containing 35 patients. Participants were instructed to swish 3 ml of either solution around their mouth for about three minutes four times a day (at least 20 min before each meal and before bedtime) until the complete healing of the oral lesions.
MAIN OUTCOME MEASURES


The primary outcome of this study was to assess the severity of pain prior to the intervention and on the first, third, and fifth days of it. This was done using the visual analog scale (VAS). The duration of wound healing was also measured through photography. The secondary outcome was to record the adverse effects of the intervention. This trial was registered at the Iranian Registry of Clinical Trials under number 1  IRCT20180407039213N1.
RESULTS


The average pain score before the treatment in the DS and DSG groups was 8. 1 ± 1.17 and 7.97 ± 1.72, respectively, and there was apparently no significant difference between them. However, there was a significant difference between the two groups in terms of the average pain scores on the first (7 ± 1.28 versus 5.31 ± 1.28), third (4.02 ± 1.8 vs. 2.86 ± 1.56) and fifth days (1.71 ± 1.69 vs. 0.54 ± 1.31) of the intervention. Indeed, DSG significantly reduced the average wound healing duration by 1.5 days, as compared to DS (P = 0.0001). No adverse effects were observed with the intervention.
CONCLUSION


According to our results, DSG appeared to be more effective in treating RAS than DS alone.
TRIAL REGISTRATION


The trial was registered at Iranian Registry of Clinical Trials before the enrolment of the first patient on June 29, 2019 (registration no: IRCT20180407039213N1, http://www.irct.ir/trial/31497).",2020,"Indeed, DSG significantly reduced the average wound healing duration by 1.5 days, as compared to DS (P = 0.0001).","['was conducted from July to September 2018 at the Faculty of Dentistry, Birjand University of Medical Sciences, Birjand, Iran', 'recurrent aphthous stomatitis (RAS', '70 patients diagnosed with RSA']","['licorice containing diphenhydramine solution', 'diphenhydramine solution (DS) and diphenhydramine-containing glycyrrhiza glabra (DSG', 'DS and DSG']","['visual analog scale (VAS', 'severity of pain prior to the intervention and on the first, third, and fifth days of it', 'average wound healing duration', 'recurrent aphthous stomatitis', 'average pain score', 'average pain scores', 'duration of wound healing', 'adverse effects']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0017987', 'cui_str': 'Licorice'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0697105', 'cui_str': 'Glycyrrhiza glabra'}, {'cui': 'C0284559', 'cui_str': 'gusperimus'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",70.0,0.19952,"Indeed, DSG significantly reduced the average wound healing duration by 1.5 days, as compared to DS (P = 0.0001).","[{'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Akbari', 'Affiliation': 'Faculty of Dentistry, Birjand University of Medical sciences, Birjand, Iran. Electronic address: narges.akbare4021@yahoo.com.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Asadimehr', 'Affiliation': 'Faculty of Dentistry, Birjand University of Medical sciences, Birjand, Iran. Electronic address: n.asadi137339@yahoo.com.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Kiani', 'Affiliation': 'Pharmacology Department, Medical School, Birjand University of Medical Sciences, Birjand, 9717853577, Iran. Electronic address: kiani.za@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102401']
3217,32444057,Effects of a short-term mindfulness-based stress reduction program on the quality of life of women with infertility: A randomized controlled clinical trial.,"BACKGROUND AND PURPOSE


Although some programs based on mindfulness-based stress reduction (MBSR) have been suggested to promote quality of life (QoL) in different conditions, limited studies have addressed their potential effects in women with infertility. In this study, we aimed to determine the effects of an MBSR program on the QoL of women with infertility.
MATERIALS AND METHODS


This randomized controlled clinical trial was conducted on 36 women with infertility, who were selected by consecutive sampling from the Infertility Center of Ahvaz Imam Khomeini Hospital, Iran. Women either participated in the MBSR program or received routine consultation in eight two-hour group sessions once a week. Women's QoL was measured using the 36-item short-form health survey before, immediately after, and one month after the intervention. The intention-to-treat analysis, with multiple imputation for missing data, was also performed.
RESULTS


The mean changes in the total score of QoL and its subscales (except for ""social functioning"" and ""bodily pain"") were significant compared to the baseline both at immediately after and one month after the intervention in favor of the experimental group (P<0.001 in most cases). Twenty four and six adverse events were recorded in the experimental and control groups, respectively.
CONCLUSION


Short-term MBSR program seem to be potentially effective in improving the QoL of women with infertility. Further studies are needed to determine the generalizability of our findings.",2020,"The mean changes in the total score of QoL and its subscales (except for ""social functioning"" and ""bodily pain"") were significant compared to the baseline both at immediately after and one month after the intervention in favor of the experimental group (P<0.001 in most cases).","['women with infertility', '36 women with infertility, who were selected by consecutive sampling from the Infertility Center of Ahvaz Imam Khomeini Hospital, Iran', 'Women either participated in the MBSR program or received']","['MBSR program', 'short-term mindfulness-based stress reduction program', 'routine consultation']","['quality of life', 'total score of QoL and its subscales (except for ""social functioning"" and ""bodily pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",36.0,0.0481449,"The mean changes in the total score of QoL and its subscales (except for ""social functioning"" and ""bodily pain"") were significant compared to the baseline both at immediately after and one month after the intervention in favor of the experimental group (P<0.001 in most cases).","[{'ForeName': 'Masoumeh Sadat', 'Initials': 'MS', 'LastName': 'Hosseini', 'Affiliation': 'Student Research Committee, Department of Midwifery, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; Fertility, Infertility and Perinatology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Masoumehsadat.hosseini@yahoo.com.'}, {'ForeName': 'Parvaneh', 'Initials': 'P', 'LastName': 'Mousavi', 'Affiliation': 'Reproductive Health Promotion Research Center, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Mousavip2009@yahoo.com.'}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Hekmat', 'Affiliation': 'Fertility, Infertility and Perinatology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; Reproductive Health Promotion Research Center, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Hekmat1346@gmail.com.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighyzadeh', 'Affiliation': 'Department of Biostatistics, School of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Haghighy-mh@ajums.ac.ir.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Johari Fard', 'Affiliation': 'Department of Psychology, Islamic Azad University, Ahvaz Branch, Ahvaz, Iran. Electronic address: Rjoharifard@gmail.com.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Mohammad Jafari', 'Affiliation': 'Fertility, Infertility and Perinatology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Rmj41@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102403']
3218,32444058,Thermo-therapy and cryotherapy to decrease the symptoms of restless leg syndrome during the pregnancy: A randomized clinical trial.,"BACKGROUND AND PURPOSE


Restless legs syndrome (RLS) is a common sensory-motor disorder among the pregnant women. The aim of this study is to compare the impacts of two methods of immersion of legs in cold and warm water on the RLS symptoms among the pregnant women.
METHODS


This randomized clinical trial was conducted on 80 pregnant women with RLS who referred to Taleghani educational-therapy center. After obtaining their informed consent, they were selected by accessible method and randomly allocated into group 1 (warm water) and group 2 (cold water). Group 1 were asked to put their legs in cold water for 10 min every night for 2 weeks. The group 2 put their legs in warm water under the same condition. The severity of RLS was measured before and after the study. Data analysis was conducted using descriptive as well as the analytical statistics such as Chi-square, independent T test, pair T test, Mann-Whitney U, Wilcoxon and covariance.
RESULTS


After intervention, mean RLS of the cold water group was11.02 ± 4.93; while this mean was 13.50 ± 4.74 in the warm water group. The difference between the two groups was significant (p = 0.017). Results also revealed that the severity of RLS symptoms at the end of the treatment was different from the beginning of the research in both groups (p = 0.001). The intervention with both warm and cold water declined the RLS symptoms among pregnant women.
CONCLUSION


The warm and cold water can be used for this purpose depending on the women's preference. However, this article recommends the cold water for more reducing of symptoms.",2020,The difference between the two groups was significant (p = 0.017).,"['80 pregnant women with RLS who referred to Taleghani educational-therapy center', 'pregnant women']",['Thermo-therapy and cryotherapy'],"['severity of RLS', 'mean RLS', 'severity of RLS symptoms', 'symptoms of restless leg syndrome', 'RLS symptoms']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0204583', 'cui_str': 'Educational therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",80.0,0.0644877,The difference between the two groups was significant (p = 0.017).,"[{'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Jafarimanesh', 'Affiliation': 'School of Nursing, School of Medicine, Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Arak, Sardasht, Iran. Electronic address: Jafarimanesh@arakmu.ac.ir.'}, {'ForeName': 'Katayon', 'Initials': 'K', 'LastName': 'Vakilian', 'Affiliation': 'Department of Midwifery, School of Medicine, Traditional and Complementary Medicine Research Center(TCMRC), Arak University of Medical Sciences, Arak, Sardasht, Iran. Electronic address: dr.kvakilian@arakmu.ac.ir.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Mobasseri', 'Affiliation': 'Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Imam Khomeini Street, Taleghani Hospital, Arak, Iran. Electronic address: shirinmobaseri@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102409']
3219,32444091,Long-term ACE inhibition in Alport syndrome: are the benefits worth the risks?,"Gross et al. present results of the EARLY PRO-TECT trial, a randomized controlled trial of ramipril versus placebo in children with early-stage Alport syndrome. Although under-enrolled and not a positive trial in the traditional sense, EARLY PRO-TECT does provide strong supportive evidence for both long-term safety and a clinical benefit of early treatment with angiotensin-converting enzyme inhibitors in slowing the progression of both albuminuria and estimated glomerular filtration rate decline in children with Alport syndrome.",2020,"Although under-enrolled and not a positive trial in the traditional sense, EARLY PRO-TECT does provide strong supportive evidence for both long-term safety and a clinical benefit of early treatment with angiotensin-converting enzyme inhibitors in slowing the progression of both albuminuria and estimated glomerular filtration rate decline in children with Alport syndrome.","['children with Alport syndrome', 'Alport syndrome', 'children with early-stage Alport syndrome']","['ramipril', 'placebo']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1567741', 'cui_str': 'Alport syndrome'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0806223,"Although under-enrolled and not a positive trial in the traditional sense, EARLY PRO-TECT does provide strong supportive evidence for both long-term safety and a clinical benefit of early treatment with angiotensin-converting enzyme inhibitors in slowing the progression of both albuminuria and estimated glomerular filtration rate decline in children with Alport syndrome.","[{'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Rheault', 'Affiliation': ""Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis, Minnesota, USA. Electronic address: rheau002@umn.edu.""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Smoyer', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, Columbus, Ohio, USA.""}]",Kidney international,['10.1016/j.kint.2020.01.030']
3220,32444132,Early Steroid Withdrawal Protocol With Basiliximab and Rituximab in ABO-Incompatible Kidney Transplant Recipients.,"OBJECTIVES


Corticosteroids remain an important component of immunosuppressive regimens in high-risk kidney transplants. In this study, we investigated the efficacy of early steroid withdrawal with basiliximab and rituximab in ABO-blood type incompatible (ABO-i) recipients of kidney transplants.
METHODS


Between 2008 and 2019, 15 patients underwent ABO-i kidney transplantation. Seven of the 15 patients were treated with a steroid maintenance protocol and the remaining 8 with an early steroid withdrawal protocol. The immunosuppressive protocol consisted of tacrolimus, mycophenolate mofetil, and methylprednisolone (MP), with basiliximab administered as induction therapy. Rituximab was administered as a single 200-mg dose 1 to 4 weeks before kidney transplantation. Two to 4 sessions of either double-filtration plasmapheresis or regular plasmapheresis or both were performed to remove anti-AB antibodies before transplantation. During surgery, MP was administered at a dose of 500 mg; thereafter, the dosage was tapered rapidly, and the drug was discontinued on day 14 post transplant.
RESULTS


In the steroid maintenance group, 2 patients experienced acute antibody-mediated rejection (AMR). One patient with severe AMR had graft loss on postoperative day 4. Patient and graft survival rates in the steroid maintenance group were 100% and 86%, respectively. MP was successfully withdrawn in the steroid withdrawal group. In this group, there was no biopsy-proven rejection. Patient and graft survival rates were 100%, and when last measured, serum creatinine level ± SD was 1.6 ± 0.8 mg/dL.
CONCLUSIONS


Our protocol successfully enabled the early withdrawal of steroids in recipients of ABO-i grafts; however, further follow-up is necessary to confirm our results.",2020,"Patient and graft survival rates were 100%, and when last measured, serum creatinine level ± SD was 1.6 ± 0.8 mg/dL.
CONCLUSIONS


Our protocol successfully enabled the early withdrawal of steroids in recipients of ABO-i grafts; however, further follow-up is necessary to confirm our results.","['high-risk kidney transplants', 'ABO-Incompatible Kidney Transplant Recipients', '15 patients underwent ABO-i kidney transplantation', 'Between 2008 and 2019', 'Seven of the 15 patients were treated with a steroid maintenance protocol and the remaining 8 with an early steroid withdrawal protocol', 'ABO-blood type incompatible (ABO-i) recipients of kidney transplants']","['Basiliximab and Rituximab', 'Rituximab', 'basiliximab and rituximab', 'double-filtration plasmapheresis or regular plasmapheresis', 'tacrolimus, mycophenolate mofetil, and methylprednisolone (MP), with basiliximab']","['acute antibody-mediated rejection (AMR', 'biopsy-proven rejection', 'serum creatinine level ± SD', 'graft loss', 'graft survival rates']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C0013184', 'cui_str': 'Drug Incompatibility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0200499', 'cui_str': 'ABO blood grouping'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]","[{'cui': 'C0676831', 'cui_str': 'basiliximab'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C5200809', 'cui_str': 'Double Filtration Plasmapheresis'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0032134', 'cui_str': 'Plasmapheresis'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}]",15.0,0.0245331,"Patient and graft survival rates were 100%, and when last measured, serum creatinine level ± SD was 1.6 ± 0.8 mg/dL.
CONCLUSIONS


Our protocol successfully enabled the early withdrawal of steroids in recipients of ABO-i grafts; however, further follow-up is necessary to confirm our results.","[{'ForeName': 'Tamotsu', 'Initials': 'T', 'LastName': 'Tojimbara', 'Affiliation': 'Department of Transplant Surgery, International University of Health and Welfare, Atami Hospital, Shizuoka, Japan. Electronic address: tojimbara@iuhw.ac.jp.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yashima', 'Affiliation': 'Department of Transplant Surgery, International University of Health and Welfare, Atami Hospital, Shizuoka, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Shirai', 'Affiliation': 'Department of Transplant Surgery, International University of Health and Welfare, Atami Hospital, Shizuoka, Japan.'}, {'ForeName': 'Tomotaka', 'Initials': 'T', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Transplant Surgery, International University of Health and Welfare, Atami Hospital, Shizuoka, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Koyama', 'Affiliation': ""Department of Surgery, Kidney Center, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Nakajima', 'Affiliation': ""Department of Surgery, Kidney Center, Tokyo Women's Medical University, Tokyo, Japan.""}]",Transplantation proceedings,['10.1016/j.transproceed.2020.01.139']
3221,32444133,Comparison of two methods for obtaining and transporting corneal samples in suspected infectious keratitis.,"BACKGROUND AND PURPOSE


The purpose of this study is to compare two alternative methods of collecting and transporting media for the diagnosis of corneal ulcers, as not all clinical settings have conventional culture materials and transport media available.
METHODS


In this open-label, prospective, comparative, and randomized study, patients with clinical suspicion of infectious keratitis with high risk of loss of vision had corneal specimens collected using two methods and transport media: Eswab scraping with Amies transport medium and 23-gauge needle scraping in BACTEC Peds broth. The order of each collection method was randomized. The samples were processed by standard methods, comparing the positivity frequencies for both by parametric and nonparametric tests, according to normality criteria.
RESULTS


Corneal infiltrates from 40 eyes of 40 patients were analyzed. Culture positivity rate was 50% for Eswab and 35% for 23-gauge needle (P=0.258). The overall growth rate of the two methods combined was not higher than with the swab alone. The results obtained with a swab were not influenced by the collection sequence (P=0.112); however, the positivity rate was significantly higher when the sample taken with the needle was performed first (P=0.046).
CONCLUSIONS


The single sample Eswab method of collection and transportation for the diagnosis of high risk corneal ulcers is a valid alternative and can be used in cases in which, for various reasons, there is no access to the full set of traditional culture materials.",2020,Culture positivity rate was 50% for Eswab and 35% for 23-gauge needle (P=0.258).,"['patients with clinical suspicion of infectious keratitis with high risk of loss of vision had corneal specimens collected using two methods and transport media: Eswab scraping with Amies transport medium and 23-gauge needle scraping in BACTEC Peds broth', 'Corneal infiltrates from 40 eyes of 40 patients were analyzed', 'suspected infectious keratitis']",['collecting and transporting media'],"['Culture positivity rate', 'positivity rate', 'overall growth rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C3898765', 'cui_str': 'Keratitis caused by infection'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0972753', 'cui_str': 'Transport medium'}, {'cui': 'C0444082', 'cui_str': 'Scrapings'}, {'cui': 'C1550050', 'cui_str': 'Amies transport medium'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0853336', 'cui_str': 'Infiltrate of cornea'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}]","[{'cui': 'C0972753', 'cui_str': 'Transport medium'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}]",40.0,0.0360887,Culture positivity rate was 50% for Eswab and 35% for 23-gauge needle (P=0.258).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chang-Sotomayor', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: meilinchangsotomayor@gmail.com.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Llorens Bellés', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: llorens.victor@gmail.com.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Latasiewicz', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: martuska1111@gmail.com.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Torras-Sanvicens', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: JTORRAS@clinic.cat.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Blanco-Domínguez', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: ire_blanco@hotmail.com.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sabater-Cruz', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: noelia.sabater@gmail.com.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sainz-de-la-Maza', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: MSAINZ@clinic.cat.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mestres', 'Affiliation': 'Microbiology Department Hospital Clínic de Barcelona, ISGlobal, Carrer de Villarroel, 170, 08036 Barcelona, Spain. Electronic address: JOBOSCH@clinic.cat.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Palma-Carvaja', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: fpalmac@gmail.com.""}]",Journal francais d'ophtalmologie,['10.1016/j.jfo.2019.10.010']
3222,32444149,Transition to forefoot strike reduces load rates more effectively than altered cadence.,"BACKGROUND


Excessive vertical impacts at landing are associated with common running injuries. Two primary gait-retraining interventions aimed at reducing impact forces are transition to forefoot strike and increasing cadence. The objective of this study was to compare the short- and long-term effects of 2 gait-retraining interventions aimed at reducing landing impacts.
METHODS


A total of 39 healthy recreational runners using a rearfoot strike and a cadence of ≤170 steps/min were randomized into cadence (CAD) or forefoot strike (FFS) groups. All participants performed 4 weeks of strengthening followed by 8 sessions of gait-retraining using auditory feedback. Vertical average load rates (VALR) and vertical instantaneous load rates (VILR) were calculated from the vertical ground reaction force curve. Both cadence and foot strike angle were measured using 3D motion analysis and an instrumented treadmill at baseline and at 1 week, 1 month, and 6 months post retraining.
RESULTS


ANOVA revealed that the FFS group had significant reductions in VALR (49.7%) and VILR (41.7%), and changes were maintained long term. Foot strike angle in the FFS group changed from 14.2° dorsiflexion at baseline to 3.4° plantarflexion, with changes maintained long term. The CAD group exhibited significant reduction only in VALR (16%) and only at 6 months. Both groups had significant and similar increases in cadence at all follow-ups (CAD, +7.2% to 173 steps/min; and FFS, +6.1% to 172 steps/min).
CONCLUSION


Forefoot strike gait-retraining resulted in significantly greater reductions in VALR and similar increases in cadence compared to cadence gait-retraining in the short and long term. Cadence gait-retraining resulted in small reductions in VALR at only the 6-month follow-up.",2020,"RESULTS


ANOVA revealed that the FFS group had significant reductions in VALR (49.7%) and VILR (41.7%), and changes were maintained long term.",['39 healthy recreational runners using a rearfoot strike and a cadence of ≤170 steps/min were randomized into'],"['2 gait-retraining interventions', 'cadence (CAD) or forefoot strike (FFS', 'gait-retraining using auditory feedback', 'Cadence gait-retraining']","['VALR', 'VILR', 'Vertical average load rates (VALR) and vertical instantaneous load rates (VILR', 'Foot strike angle', 'cadence']","[{'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",39.0,0.0737562,"RESULTS


ANOVA revealed that the FFS group had significant reductions in VALR (49.7%) and VILR (41.7%), and changes were maintained long term.","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Futrell', 'Affiliation': 'Department of Physical Therapy, Springfield College, Springfield, MA 01109, USA; Spaulding National Running Center, Harvard Medical School, Cambridge, MA 02138, USA. Electronic address: efutrell@springfieldcollege.edu.'}, {'ForeName': 'K Douglas', 'Initials': 'KD', 'LastName': 'Gross', 'Affiliation': 'Department of Physical Therapy, MGH Institute of Health Professions, Boston, MA 02129, USA.'}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Reisman', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE 19713, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Mullineaux', 'Affiliation': 'School of Sport and Exercise Science, University of Lincoln, Brayford Pool, Lincoln, Lincolnshire, Brayford Pool, LN6 7TS, UK.'}, {'ForeName': 'Irene S', 'Initials': 'IS', 'LastName': 'Davis', 'Affiliation': 'Spaulding National Running Center, Harvard Medical School, Cambridge, MA 02138, USA; Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA 02115, USA.'}]",Journal of sport and health science,['10.1016/j.jshs.2019.07.006']
3223,32444309,Slow low-dose oral immunotherapy: Threshold and immunological change.,"BACKGROUND


We examined the feasibility, efficacy and safety of slow low-dose oral immunotherapy (SLOIT) for egg, milk, wheat allergies, with accepted severity-stratified initial and maintenance doses.
METHODS


Children with food allergies defined by low-dose oral food challenges (LD-OFCs) to hen's egg (cumulative protein dose up to 983 mg, n = 133), cow's milk (287 mg, n = 50), and wheat (226 mg, n = 45) were recruited. Participants were divided into two groups [SLOIT and control (complete avoidance]) based on their preferences. Participants who selected SLOIT were instructed to take the safe dose daily, with monthly increases, aiming to increase the dose by 10 times in one year. The primary outcome was the proportion of participants who passed the LD-OFCs following 1 year of therapy.
RESULTS


The participants in SLOIT group ingested their antigen 92.9% of the therapy's day on average. The proportion of participants who passed LD-OFCs was 35.9% (61/170) in the SLOIT group and 8.7% (4/46) in the control group (P < .001); no large differences were observed among allergens. Among the subjects who failed LD-OFCs, the median change in the total dose in the LD-OFC was 235% (interquartile range: 100%-512%) in the SLOIT group and 100% (42%-235%) in the control group (P < .001). Provoked allergic symptoms were observed in only 0.58% (280/48,486) per programmed intake and approximately 50% of the SLOIT group did not experience any obvious allergic symptoms throughout therapy.
CONCLUSIONS


SLOIT showed significant feasibility, efficacy and safety, providing a promising option to manage patients with severe food allergies.",2020,"Provoked allergic symptoms were observed in only 0.58% (280/48,486) per programmed intake and approximately 50% of the SLOIT group did not experience any obvious allergic symptoms throughout therapy.
","['Participants who selected SLOIT', ""Children with food allergies defined by low-dose oral food challenges (LD-OFCs) to hen's egg (cumulative protein dose up to 983\xa0mg, n\xa0=\xa0133), cow's milk (287\xa0mg, n\xa0=\xa050), and wheat (226\xa0mg, n\xa0=\xa045) were recruited"", 'patients with severe food allergies']","['slow low-dose oral immunotherapy (SLOIT', 'Slow low-dose oral immunotherapy', 'SLOIT']","['feasibility, efficacy and safety', 'proportion of participants who passed LD-OFCs', 'Provoked allergic symptoms', 'proportion of participants who passed the LD-OFCs']","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",45.0,0.0801129,"Provoked allergic symptoms were observed in only 0.58% (280/48,486) per programmed intake and approximately 50% of the SLOIT group did not experience any obvious allergic symptoms throughout therapy.
","[{'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Sugiura', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan. Electronic address: bee_jayz@hotmail.com.""}, {'ForeName': 'Katsumasa', 'Initials': 'K', 'LastName': 'Kitamura', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan.""}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Makino', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan.""}, {'ForeName': 'Teruaki', 'Initials': 'T', 'LastName': 'Matsui', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan.""}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Furuta', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan.""}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Takasato', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan.""}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Kando', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan.""}, {'ForeName': 'Komei', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan.""}]",Allergology international : official journal of the Japanese Society of Allergology,['10.1016/j.alit.2020.03.008']
3224,32444327,Effects of aldose reductase inhibitors on renal blood flow parameters in patients with early diabetic nephropathy.,"OBJECTIVE


To investigate the changes of renal blood flow parameters in patients with early-stage diabetic nephropathy (DN) treated with Aldose reductase inhibitors (ARI)/Epalrestat.
METHODS


In this prospective, 120 early DN patients aged 20-75 years from the Endocrinology Department of Chengyang District People's Hospital of Qingdao City in 2015 were randomized to intervention group including 68 patients and control group including 52 patients. Two groups of patients separately received Epalrestat and placebo for 3 months. Renal vascular parameters and blood biochemical index were collected at baseline and after intervention.
RESULTS


After 3 months of supplementation, Epalrestat significantly improved the renal and segmental renal arterial end-diastolic blood flow velocity (EDV) and the interlobular artery peak systolic blood flow velocity (PSV) compared with placebo. While Epalrestat markedly decreased the blood flow resistance index (RI) in interlobular artery compared to placebo. There were no significant changes in fasting blood glucose (FBG), diastolic blood pressure (DBP), systolic blood pressure (SBP), serum urinary acid (SUA), low-density lipoprotein cholesterol (LDL), triacylglycerol (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL), waist circumference (WC) and body mass index (BMI).
CONCLUSION


Epalrestat can effectively improve renal arterial blood flow and renal arterial perfusion, which play a protective role in early DN.",2020,While Epalrestat markedly decreased the blood flow resistance index (RI) in interlobular artery compared to placebo.,"[""120 early DN patients aged 20-75\u202fyears from the Endocrinology Department of Chengyang District People's Hospital of Qingdao City in 2015 were randomized to intervention group including 68 patients and control group including 52 patients"", 'patients with early diabetic nephropathy', 'patients with early-stage diabetic nephropathy (DN) treated with']","['placebo', 'Epalrestat and placebo', 'aldose reductase inhibitors', 'Aldose reductase inhibitors (ARI)/Epalrestat']","['renal arterial blood flow and renal arterial perfusion', 'renal blood flow parameters', 'fasting blood glucose (FBG), diastolic blood pressure (DBP), systolic blood pressure (SBP), serum urinary acid (SUA), low-density lipoprotein cholesterol (LDL), triacylglycerol (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL), waist circumference (WC) and body mass index (BMI', 'renal and segmental renal arterial end-diastolic blood flow velocity (EDV) and the interlobular artery peak systolic blood flow velocity (PSV', 'blood flow resistance index (RI', 'Renal vascular parameters and blood biochemical index']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0587463', 'cui_str': 'Endocrinology department'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0095278', 'cui_str': 'epalrestat'}, {'cui': 'C3653979', 'cui_str': 'Aldose reductase inhibitors'}, {'cui': 'C0002003', 'cui_str': 'Aldehyde reductase'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0398345', 'cui_str': 'Arterial perfusion'}, {'cui': 'C0035070', 'cui_str': 'Circulation, Renal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}]",2015.0,0.0377669,While Epalrestat markedly decreased the blood flow resistance index (RI) in interlobular artery compared to placebo.,"[{'ForeName': 'Mingxia', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Laizhou People's Hospital, No.1718 Wuli Street, Laizhou City 261400, Shandong, China.""}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Laizhou People's Hospital, No.1718 Wuli Street, Laizhou City 261400, Shandong, China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': ""Department of Endocrinology, Chengyang People's Hospital in Qingdao, No.600 Changcheng Road Chengyang District, Qingdao 266109, China.""}, {'ForeName': 'Xiaopang', 'Initials': 'X', 'LastName': 'Rao', 'Affiliation': ""Department of Endocrinology, Chengyang People's Hospital in Qingdao, No.600 Changcheng Road Chengyang District, Qingdao 266109, China. Electronic address: docrxp@126.com.""}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107620']
3225,32444343,"The effect of acute aerobic exercise on central arterial stiffness, wave reflection and hemodynamics in adults with diabetes: A randomized cross-over design.","BACKGROUND


Individuals with diabetes have greater central arterial stiffness, wave reflections, and hemodynamics, all of which promote the accelerated cardiovascular pathology seen in this population. Acute aerobic exercise has been shown to be an effective strategy for reducing central arterial stiffness, wave reflections, and hemodynamics in healthy individuals; however, the effects of acute aerobic exercise in reducing these outcomes is not well established in people with diabetes. Recently, implementation of high-intensity interval exercise (HIIE) has shown superior improvements in cardiovascular health outcomes when compared to traditional aerobic exercise. Yet, the effect of HIIE on the aforementioned outcomes in people with diabetes is not known. The purpose of this study was to: (i) describe the central arterial stiffness, wave reflections, and hemodynamic responses to a bout of HIIE and moderate-intensity continuous exercise (MICE) in adults with diabetes; and (ii) compare the effects of HIIE and MICE on the aforementioned outcomes.
METHODS


A total of 24 adult men and women (aged 29-59 years old) with type 1 (n = 12) and type 2 (n = 12) diabetes participated in a randomized cross-over study. All participants completed the following protocols: (i) HIIE: cycling for 4 × 4 min at 85%-95% of heart rate peak (HR peak ), interspersed with 3 min of active recovery at 60%-70% HR peak ; (ii) MICE: 33 min of continuous cycling at 60%-70% of HR peak ; and (iii) control (CON): lying quietly in a supine position for 30 min.
RESULTS


A significant group × time effect was found for changes in central systolic blood pressure (F = 3.20, p = 0.01) with a transient reduction for the HIIE group but not for the MICE or CON groups. There was a significant group × time effect for changes in augmentation index at a heart rate of 75 beats/min (F = 2.32, p = 0.04) with a decrease following for HIIE and MICE but not for CON. For all other measures of central arterial stiffness and hemodynamics, no significant changes were observed (p > 0.05).
CONCLUSION


A bout of HIIE appears to lead to a greater transient reduction in central systolic blood pressure than the reduction observed following MICE; however, both HIIE and MICE improved augmentation index at a heart rate of 75 beats/min in people with diabetes. There was no significant difference in response to HIIE and MICE in all outcomes. This provides preliminary evidence on the role of HIIE on such outcomes in people with diabetes.",2020,"For all other measures of central arterial stiffness and hemodynamics, no significant changes were observed (p > 0.05).
","['people with diabetes', '24 adult men and women (aged 29-59 years old) with type 1 (n\u202f=\u202f12) and type 2 (n\u202f=\u202f12) diabetes participated in a randomized cross-over study', 'healthy individuals', 'adults with diabetes', 'Individuals with diabetes']","['MICE', 'HIIE and moderate-intensity continuous exercise (MICE', 'Acute aerobic exercise', 'acute aerobic exercise', 'HIIE and MICE']","['central arterial stiffness, wave reflections, and hemodynamic responses', 'central arterial stiffness and hemodynamics', 'cardiovascular health outcomes', 'response to HIIE and MICE', 'augmentation index', 'central systolic blood pressure', 'augmentation index at a heart rate', 'central arterial stiffness, wave reflection and hemodynamics']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",24.0,0.0774815,"For all other measures of central arterial stiffness and hemodynamics, no significant changes were observed (p > 0.05).
","[{'ForeName': 'Kimberley L', 'Initials': 'KL', 'LastName': 'Way', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sports Science, University of Sydney, Lidcombe, 2141, Australia; Charles Perkins Centre, University of Sydney, Camperdown, 2006, Australia; Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, 2006, Australia. Electronic address: KWay@ottawaheart.ca.'}, {'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Lee', 'Affiliation': 'Charles Perkins Centre, University of Sydney, Camperdown, 2006, Australia; Faculty of Medicine and Health, Central Clinical School, University of Sydney, Camperdown, 2006, Australia; Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, 2050, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Twigg', 'Affiliation': 'Charles Perkins Centre, University of Sydney, Camperdown, 2006, Australia; Faculty of Medicine and Health, Central Clinical School, University of Sydney, Camperdown, 2006, Australia; Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, 2050, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sports Science, University of Sydney, Lidcombe, 2141, Australia; Charles Perkins Centre, University of Sydney, Camperdown, 2006, Australia; Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, 2006, Australia.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.02.009']
3226,32444401,"Self-titration of inhaled corticosteroid and beta 2 -agonist in response to symptoms in mild asthma - a pre-specified analysis from the PRACTICAL study, a randomised controlled trial.","BACKGROUND


In mild asthma, as-needed budesonide-formoterol is superior or non-inferior to maintenance budesonide plus as-needed short-acting beta 2- agonist in reducing severe exacerbations. In this pre-specified analysis, we investigated patterns of inhaled corticosteroid (ICS) and beta 2 -agonist use in PRACTICAL, a randomised controlled trial.
METHODS


Participants were randomised 1:1 to as-needed budesonide-formoterol (200/6 mcg Turbuhaler, 1 prn) or maintenance budesonide (200 mcg Turbuhaler, 1 bd) with as-needed terbutaline (250 mcg, 2 prn) for 52 weeks; 110 participants had electronic monitors attached to their study inhalers which captured the time and date of every actuation. Key outcome measures were patterns of ICS and beta 2- agonist use. One actuation of budesonide-formoterol was considered to be an equivalent bronchodilator dose as two actuations of terbutaline.
FINDINGS


Participants randomised to as-needed budesonide-formoterol had more days with no ICS use compared with maintenance budesonide (median total days of no use 156  versus  22 days respectively), lower median daily budesonide dose (164  versus  328 mcg respectively), and a greater median number of days of ≥4 budesonide actuations (4  versus  1 days respectively). Participants randomised to as-needed budesonide-formoterol took higher equivalent doses of beta 2 -agonist both overall (median number of actuations 0.8  versus  0.3 per day respectively) and in response to worsening asthma (total number of ""overuse days"" of >8 or >16 actuations of budesonide-formoterol or terbutaline 33  versus  10 respectively).
INTERPRETATION


The timing of ICS dose when self-titrated to beta 2 -agonist use is more important than total ICS dose in reducing severe exacerbation risk in mild asthma, when associated with greater overall use of as-needed beta 2 -agonist.",2020,"use is more important than total ICS dose in reducing severe exacerbation risk in mild asthma, when associated with greater overall use of as-needed beta 2 -agonist.","['Participants', 'mild asthma ']","['agonist', 'maintenance budesonide', 'terbutaline', 'inhaled corticosteroid and beta 2 -agonist', 'budesonide-formoterol or terbutaline 33  versus  10 respectively', 'inhaled corticosteroid (ICS', 'budesonide-formoterol']","['median number of days of ≥4 budesonide actuations', 'severe exacerbations', 'patterns of ICS and beta']","[{'cui': 'C0581124', 'cui_str': 'Mild asthma'}]","[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0039542', 'cui_str': 'Terbutaline'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C4319628', 'cui_str': 'Actuation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]",,0.646451,"use is more important than total ICS dose in reducing severe exacerbation risk in mild asthma, when associated with greater overall use of as-needed beta 2 -agonist.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Baggott', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand christina.baggott@mrinz.ac.nz.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Hardy', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Sparks', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Holliday', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hall', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Vohlidkova', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hancox', 'Affiliation': 'University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'University of Otago, Wellington, New Zealand.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fingleton', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.00170-2020']
3227,32444402,Predicting extubation outcomes using Heart Rate Characteristics Index in Preterm Infants: A cohort study.,"A strategy of early extubation to non-invasive respiratory support in preterm infants could be boosted by the availability of a decision-support tool for clinicians. Using the Heart Rate Characteristics index (HRCi) with clinical parameters, we derived and validated predictive models for extubation readiness and success.Peri-extubation demographic, clinical and HRCi data for up to 96 h were collected from mechanically ventilated infants in the control arm of a randomised trial involving 8 neonatal centres, where clinicians were blinded to the HRCi scores. The data was used to produce a multivariable regression model for the probability of subsequent re-intubation. Additionally, a survival model was produced to estimate the probability of reintubation in the period after extubation.Of the 577 eligible infants, data from 397 infants (2/3rd) were used to derive the pre-extubation model and 180 infants for validation. The model was also fitted and validated using all combinations of training (5-centres) and test (3-centres) centres. The estimated probability for the validation episodes showed discrimination with high statistical significance, with the area under the curve of 0.72 (0.71, 0.74; p<0.001). Data from all infants were used to derive models of the predictive instantaneous hazard of re-intubation adjusted for clinical parameters.Predictive models of extubation readiness and success in real-time can be derived using physiological and clinical variables. The models from our analyses can be accessed using an online tool at www.heroscore.com/extubation/ and have the potential to inform and supplement the confidence of the clinician considering extubation in preterm infants.",2020,"The estimated probability for the validation episodes showed discrimination with high statistical significance, with the area under the curve of 0.72 (0.71, 0.74; p<0.001).","['577 eligible infants, data from 397 infants (2/3rd) were used to derive the pre-extubation model and 180 infants for validation', 'Preterm Infants', 'preterm infants']",[],[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]",[],[],577.0,0.0843375,"The estimated probability for the validation episodes showed discrimination with high statistical significance, with the area under the curve of 0.72 (0.71, 0.74; p<0.001).","[{'ForeName': 'Mallinath', 'Initials': 'M', 'LastName': 'Chakraborty', 'Affiliation': 'Regional Neonatal Intensive Care Unit, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'William John', 'Initials': 'WJ', 'LastName': 'Watkins', 'Affiliation': 'Department of Infection and Immunity, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Tansey', 'Affiliation': 'Department of Infection and Immunity, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'King', 'Affiliation': 'Medical Predictive Science Corporation, Charlottesville, VA, USA.'}, {'ForeName': 'Sujoy', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Neonatal Intensive Care Unit, Singleton Hospital, Swansea, UK.'}]",The European respiratory journal,['10.1183/13993003.01755-2019']
3228,32444407,Effects of downhill walking in pulmonary rehabilitation for patients with COPD: a randomised controlled trial.,"BACKGROUND


The development of contractile muscle fatigue (CMF) affects training responses in patients with COPD. Downhill walking induces CMF with lower dyspnoea and fatigue than level walking. This study compared the effect of pulmonary rehabilitation (PR) comprising downhill walking training (DT) to PR comprising level walking (conventional training, CT) in patients with COPD.
METHODS


In this randomised controlled trial, thirty five patients (62±8 years; FEV 1  50±17%pred) were randomised to DT or CT. Exercise tolerance (6-minute walk test distance, 6MWD [primary outcome]), muscle function, symptoms, quality-of-life and physical activity levels were assessed before and after PR. Absolute training changes and the proportion of patients exceeding the 30 m 6MWD minimally important difference (MID) were compared between groups. Quadriceps muscle biopsies were collected after PR in a subset of patients to examine physiological responses to long-term eccentric training.
RESULTS


No between-group differences were observed in absolute 6MWD improvement (mean 6MWD Δ77±46 m DT  versus  56±47 m CT; p=0.45), however 94% of patients in DT exceeded the 6MWD MID compared to 65% in CT (p=0.03). Patients in DT tended to have larger improvements than CT in other outcomes. Muscle biopsy analyses did not differ between groups.
CONCLUSION


PR incorporating downhill walking confers similar magnitudes of effects to PR with conventional walking across clinical outcomes in patients with COPD, however offers a more reliable stimulus to maximise the achievement of clinically relevant gains in functional exercise tolerance in people with COPD.",2020,"PR incorporating downhill walking confers similar magnitudes of effects to PR with conventional walking across clinical outcomes in patients with COPD, however offers a more reliable stimulus to maximise the achievement of clinically relevant gains in functional exercise tolerance in people with COPD.","['people with COPD', 'thirty five patients (62±8\u2005years; FEV 1  50±17%pred', 'patients with COPD']","['pulmonary rehabilitation (PR) comprising downhill walking training (DT) to PR comprising level walking (conventional training, CT', '6MWD Δ77±46\u2005m DT  versus  56±47', 'Downhill walking induces CMF', 'CT', 'DT or CT', 'downhill walking']","['absolute 6MWD improvement', 'Exercise tolerance (6-minute walk test distance, 6MWD [primary outcome]), muscle function, symptoms, quality-of-life and physical activity levels', 'Quadriceps muscle biopsies', '6MWD MID']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle'}, {'cui': 'C0444598', 'cui_str': 'Mid'}]",35.0,0.099033,"PR incorporating downhill walking confers similar magnitudes of effects to PR with conventional walking across clinical outcomes in patients with COPD, however offers a more reliable stimulus to maximise the achievement of clinically relevant gains in functional exercise tolerance in people with COPD.","[{'ForeName': 'Carlos Augusto', 'Initials': 'CA', 'LastName': 'Camillo', 'Affiliation': 'KU Leuven, Department of Rehabilitation Sciences, Leuven, Belgium.'}, {'ForeName': 'Christian Robert', 'Initials': 'CR', 'LastName': 'Osadnik', 'Affiliation': 'KU Leuven, Department of Rehabilitation Sciences, Leuven, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Burtin', 'Affiliation': 'KU Leuven, Department of Rehabilitation Sciences, Leuven, Belgium.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Everaerts', 'Affiliation': 'KU Leuven, Department of Rehabilitation Sciences, Leuven, Belgium.'}, {'ForeName': 'Miek', 'Initials': 'M', 'LastName': 'Hornikx', 'Affiliation': 'KU Leuven, Department of Rehabilitation Sciences, Leuven, Belgium.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Demeyer', 'Affiliation': 'KU Leuven, Department of Rehabilitation Sciences, Leuven, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Loeckx', 'Affiliation': 'KU Leuven, Department of Rehabilitation Sciences, Leuven, Belgium.'}, {'ForeName': 'Fernanda Machado', 'Initials': 'FM', 'LastName': 'Rodrigues', 'Affiliation': 'KU Leuven, Department of Rehabilitation Sciences, Leuven, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Maes', 'Affiliation': 'Laboratory of Pneumology, Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Gayan-Ramirez', 'Affiliation': 'Laboratory of Pneumology, Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Janssens', 'Affiliation': 'University Hospital Leuven, Respiratory Division and Rehabilitation, Leuven, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Troosters', 'Affiliation': 'KU Leuven, Department of Rehabilitation Sciences, Leuven, Belgium thierry.troosters@kuleuven.be.'}]",The European respiratory journal,['10.1183/13993003.00639-2020']
3229,32444433,"Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS).","INTRODUCTION


Shoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use. This trial will evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.New surgical procedures can provide substantial benefit to patients. Good quality randomised controlled trials (RCTs) are needed, but trials in surgery are typically long and expensive, exposing patients to risk and the healthcare system to substantial costs. One way to improve the efficiency of trials is with an adaptive sample size. Such methods are well established in drug trials but have rarely, if ever, been used in surgical trials.
METHODS AND ANALYSIS


Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) is a participant and assessor blinded, adaptive, multicentre RCT comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear. It uses a group sequential adaptive design where interim analyses are performed using all of the 3, 6 and 12-month data that are available at each time point. A maximum of 221 participants will be randomised (1:1 ratio), this will provide 90% power (at the 5% level) for a 6 point difference in the primary outcome; the Oxford Shoulder Score at 12 months. A substudy will use deltoid-active MRI scans in 56 participants to assess the function of the balloon. Analysis will be on an intention-to-treat basis and reported according to principles established in the Consolidated Standards of Reporting Trials statement.
ETHICS AND DISSEMINATION


NRES number 18/WM/0025. The results will be disseminated via peer-reviewed publications, presentations at conferences, lay summaries and social media.
TRIAL REGISTRATION NUMBER


ISRCTN17825590.",2020,"A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use.","['56 participants', 'Subacromial spacer for Tears Affecting Rotator cuff Tendons', 'Tears Affecting Rotator cuff Tendons', '221 participants', 'people with a symptomatic irreparable rotator cuff tear', 'individuals undergoing arthroscopic debridement for irreparable rotator cuff tears']","['subacromial balloon spacer', 'arthroscopic debridement with the InSpace balloon (Stryker, USA', 'deltoid-active MRI scans', 'arthroscopic debridement alone', 'Subacromial spacer']",['Oxford Shoulder Score'],"[{'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}]",221.0,0.251892,"A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Metcalfe', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK A.Metcalfe@warwick.ac.uk.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Gemperle Mannion', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parsons', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Fox', 'Affiliation': 'Patient Representative, Durham, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kearney', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Lawrence', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Bush', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'McGowan', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Iftekhar', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Hutchinson', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Drew', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}]",BMJ open,['10.1136/bmjopen-2020-036829']
3230,32444457,Effects of Linagliptin on Cardiovascular and Kidney Outcomes in People With Normal and Reduced Kidney Function: Secondary Analysis of the CARMELINA Randomized Trial.,"OBJECTIVE


Type 2 diabetes is a leading cause of kidney failure, but few outcome trials proactively enrolled individuals with chronic kidney disease (CKD). We performed secondary analyses of cardiovascular (CV) and kidney outcomes across baseline estimated glomerular filtration rate (eGFR) categories (≥60, 45 to <60, 30 to <45, and <30 mL/min/1.73 m 2 ) in Cardiovascular and Renal Microvascular Outcome Study With Linagliptin (CARMELINA), a cardiorenal placebo-controlled outcome trial of the dipeptidyl peptidase 4 inhibitor linagliptin (NCT01897532).
RESEARCH DESIGN AND METHODS


Participants with CV disease and/or CKD were included. The primary outcome was time to first occurrence of CV death, nonfatal myocardial infarction, or nonfatal stroke (three-point major adverse CV event [3P-MACE]), with a secondary outcome of renal death, end-stage kidney disease, or sustained ≥40% decrease in eGFR from baseline. Other end points included progression of albuminuria, change in HbA 1c , and adverse events (AEs) including hypoglycemia.
RESULTS


A total of 6,979 subjects (mean age 65.9 years; eGFR 54.6 mL/min/1.73 m 2 ; 80.1% albuminuria) were followed for 2.2 years. Across eGFR categories, linagliptin as compared with placebo did not affect the risk for 3P-MACE (hazard ratio 1.02 [95% CI 0.89, 1.17]) or the secondary kidney outcome (1.04 [0.89, 1.22]) (interaction  P  values >0.05). Regardless of eGFR, albuminuria progression was reduced with linagliptin, as was HbA 1c , without increasing risk for hypoglycemia. AEs were balanced among groups overall and across eGFR categories.
CONCLUSIONS


Across all GFR categories, in participants with type 2 diabetes and CKD and/or CV disease, there was no difference in risk for linagliptin versus placebo on CV and kidney events. Significant reductions in risk for albuminuria progression and HbA 1c  and no difference in AEs were observed.",2020,"Across eGFR categories, linagliptin as compared with placebo did not affect the risk for 3P-MACE (hazard ratio 1.02 [95% CI 0.89, 1.17]) or the secondary kidney outcome (1.04 [0.89, 1.22]) (interaction  P  values >0.05).","['enrolled individuals with chronic kidney disease (CKD', '6,979 subjects (mean age 65.9 years; eGFR 54.6 mL/min/1.73 m 2 ; 80.1% albuminuria', 'People With Normal and Reduced Kidney Function', 'Participants with CV disease and/or CKD were included']","['placebo', 'Linagliptin', 'linagliptin']","['risk for 3P-MACE', 'time to first occurrence of CV death, nonfatal myocardial infarction, or nonfatal stroke', 'cardiovascular (CV) and kidney outcomes across baseline estimated glomerular filtration rate (eGFR) categories', 'progression of albuminuria, change in HbA 1c , and adverse events (AEs) including hypoglycemia', 'eGFR, albuminuria progression', 'CV and kidney events', 'risk for albuminuria progression and HbA 1c  and no difference in AEs', 'Cardiovascular and Kidney Outcomes', 'secondary kidney outcome', 'renal death, end-stage kidney disease, or sustained ≥40% decrease in eGFR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",6979.0,0.362961,"Across eGFR categories, linagliptin as compared with placebo did not affect the risk for 3P-MACE (hazard ratio 1.02 [95% CI 0.89, 1.17]) or the secondary kidney outcome (1.04 [0.89, 1.22]) (interaction  P  values >0.05).","[{'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'Faculty of Medicine, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia vlado.perkovic@unsw.edu.au.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Toto', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': 'Department of Diabetes, Central Clinical School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'Kuratorium für Dialyse Kidney Centre, Munich, Germany.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center, Dallas, TX.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, VA Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke Health, Durham, NC.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Egon', 'Initials': 'E', 'LastName': 'Pfarr', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schnaidt', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meinicke', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Maximillian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-0279']
3231,32444517,Cluster Randomized Trial Evaluating Impact of a Community-based Microfinance Scheme on Childhood Nutritional Status: Evidence-based Medicine Viewpoint.,,2020,,[],['Community-based Microfinance Scheme'],[],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0435444,,"[{'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Mathew', 'Affiliation': 'Department of Pediatrics, PGIMER, Chandigarh, India. dr.joseph.l.mathew@gmail.com.'}]",Indian pediatrics,[]
3232,32444518,Cluster Randomized Trial Evaluating Impact of a Community-based Microfinance Scheme on Childhood Nutritional Status: Pediatrician's Viewpoint.,,2020,,[],['Community-based Microfinance Scheme'],[],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0246971,,"[{'ForeName': 'Manoja Kumar', 'Initials': 'MK', 'LastName': 'Das', 'Affiliation': 'The INCLEN Trust International, New Delhi, India. manoj@inclentrust.org.'}]",Indian pediatrics,[]
3233,32444519,Cluster Randomized Trial Evaluating Impact of a Community-based Microfinance Scheme on Childhood Nutritional Status: Nutritionist's Viewpoint.,,2020,,['Childhood Nutritional Status'],['Community-based Microfinance Scheme'],[],"[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0243304,,"[{'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Department of Pediatrics, LHMC and KSCH, New Delhi, India. pkpaed@gmail.com.'}]",Indian pediatrics,[]
3234,32444540,Tolcapone Treatment for Cognitive and Behavioral Symptoms in Behavioral Variant Frontotemporal Dementia: A Placebo-Controlled Crossover Study.,"BACKGROUND


There are currently no disease-targeted treatments for cognitive or behavioral symptoms in patients with behavioral variant frontotemporal dementia (bvFTD).
OBJECTIVE


To determine the effect of tolcapone, a specific inhibitor of Catechol-O-Methyltransferase (COMT), in patients with bvFTD.
METHODS


In this randomized, double-blind, placebo-controlled, cross-over study at two study sites, we examined the effect of tolcapone on 28 adult outpatients with bvFTD. The primary outcome was reaction time on the N-back cognitive test. As an imaging outcome, we examined differences in the resting blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) signal intensity between subjects on placebo versus tolcapone performing the N-back test. Secondary outcomes included measures of cognitive performance and behavioral disturbance using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Neuropsychiatric Inventory-Questionnaire (NPI-Q), and Clinical Global Impressions scale (CGI).
RESULTS


Tolcapone was well tolerated and no patients dropped out. The most frequent treatment-related adverse event during tolcapone treatment was elevated liver enzymes (21%). There were no significant differences between tolcapone treatment and placebo in the primary or imaging outcomes. However, there were significant differences between RBANS total scores (p < 0.01), NPI-Q total scores (p = 0.04), and CGI total scores (p = 0.035) between treatment conditions which were driven by differences between baseline and tolcapone conditions. Further, there was a trend toward significance between tolcapone and placebo on the CGI (p = 0.078).
CONCLUSIONS


Further study of COMT inhibition and related approaches with longer duration of treatment and larger sample sizes in frontotemporal lobar degeneration-spectrum disorders may be warranted.",2020,"However, there were significant differences between RBANS total scores (p < 0.01), NPI-Q total scores (p = 0.04), and CGI total scores (p = 0.035) between treatment conditions which were driven by differences between baseline and tolcapone conditions.","['patients with behavioral variant frontotemporal dementia (bvFTD', 'Behavioral Variant Frontotemporal Dementia', 'patients with bvFTD', '28 adult outpatients with bvFTD']","['Tolcapone', 'Placebo', 'tolcapone and placebo', 'placebo versus tolcapone', 'tolcapone, a specific inhibitor of Catechol-O-Methyltransferase (COMT', 'tolcapone', 'placebo']","['Cognitive and Behavioral Symptoms', 'tolerated', 'RBANS total scores', 'NPI-Q total scores', 'reaction time on the N-back cognitive test', 'cognitive performance and behavioral disturbance using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Neuropsychiatric Inventory-Questionnaire (NPI-Q), and Clinical Global Impressions scale (CGI', 'CGI total scores', 'resting blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) signal intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4011788', 'cui_str': 'Behavioral variant of frontotemporal dementia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0246330', 'cui_str': 'tolcapone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}]","[{'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",28.0,0.476147,"However, there were significant differences between RBANS total scores (p < 0.01), NPI-Q total scores (p = 0.04), and CGI total scores (p = 0.035) between treatment conditions which were driven by differences between baseline and tolcapone conditions.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fremont', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, NY, USA.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Manoochehri', 'Affiliation': 'Taub Institute, Columbia University, New York, NY, USA.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Armstrong', 'Affiliation': 'Laboratory of Behavioral Neuroscience, NIA/NIH, Bethesda, MD, USA.'}, {'ForeName': 'Venkata S', 'Initials': 'VS', 'LastName': 'Mattay', 'Affiliation': 'Lieber Institute for Brain Development, Johns Hopkins Medical Campus, Baltimore, MD, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Apud', 'Affiliation': 'Section on Integrative Neuroimaging, Clinical & Translational Neuroscience Branch, Intramural Research Program, NIMH/NIH, Bethesda, MD, USA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Tierney', 'Affiliation': 'Behavioral Neurology Unit, Intramural Research Program, NINDS/NIH, Bethesda, MD, USA.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, NY, USA.'}, {'ForeName': 'Yunglin', 'Initials': 'Y', 'LastName': 'Gazes', 'Affiliation': 'Department of Neurology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Habeck', 'Affiliation': 'Department of Neurology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wassermann', 'Affiliation': 'Behavioral Neurology Unit, Intramural Research Program, NINDS/NIH, Bethesda, MD, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Grafman', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Cognitive Neuroscience Laboratory, Brain Injury Research, Shirley Ryan AbilityLab, Feinberg School of Medicine, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Huey', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, NY, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191265']
3235,32444553,Effect of a Multimodal Lifestyle Intervention on Sleep and Cognitive Function in Older Adults with Probable Mild Cognitive Impairment and Poor Sleep: A Randomized Clinical Trial.,"BACKGROUND


Poor sleep is common among older adults with mild cognitive impairment (MCI) and may contribute to further cognitive decline. Whether multimodal lifestyle intervention that combines bright light therapy (BLT), physical activity (PA), and good sleep hygiene can improve sleep in older adults with MCI and poor sleep is unknown.
OBJECTIVE


To assess the effect of a multimodal lifestyle intervention on sleep in older adults with probable MCI and poor sleep.
METHODS


This was a 24-week proof-of-concept randomized trial of 96 community-dwelling older adults aged 65-85 years with probable MCI (<26/30 on the Montreal Cognitive Assessment) and poor sleep (>5 on the Pittsburgh Sleep Quality Index [PSQI]). Participants were allocated to either a multimodal lifestyle intervention (INT); or 2) education + attentional control (CON). INT participants received four once-weekly general sleep hygiene education classes, followed by 20-weeks of: 1) individually-timed BLT; and 2) individually-tailored PA promotion. Our primary outcome was sleep efficiency measured using the MotionWatch8© (MW8). Secondary outcomes were MW8-measured sleep duration, fragmentation index, wake-after-sleep-onset, latency, and PSQI-measured subjective sleep quality.
RESULTS


There were no significant between-group differences in MW8 measured sleep efficiency at 24-weeks (estimated mean difference [INT -CON]: 1.18%; 95% CI [-0.99, 3.34]), or any other objective-estimate of sleep. However, INT participants reported significantly better subjective sleep quality at 24-weeks (estimated mean difference: -1.39; 95% CI [-2.72, -0.06]) compared to CON.
CONCLUSION


Among individuals with probable MCI and poor sleep, a multimodal lifestyle intervention improves subjective sleep quality, but not objectively estimated sleep.",2020,"However, INT participants reported significantly better subjective sleep quality at 24-weeks (estimated mean difference: -1.39; 95% CI [-2.72, -0.06]) compared to CON.
","['older adults with probable MCI and poor sleep', 'individuals with probable MCI and poor sleep', 'older adults with MCI and poor sleep', 'Older Adults with Probable Mild Cognitive Impairment and Poor Sleep', '96 community-dwelling older adults aged 65-85 years with probable MCI (<26/30 on the Montreal Cognitive Assessment) and poor sleep (>5 on the Pittsburgh Sleep Quality Index [PSQI', 'older adults with mild cognitive impairment (MCI']","['multimodal lifestyle intervention that combines bright light therapy (BLT), physical activity (PA), and good sleep hygiene', 'multimodal lifestyle intervention (INT); or 2) education\u200a+\u200aattentional control (CON', 'multimodal lifestyle intervention', 'Multimodal Lifestyle Intervention', 'weekly general sleep hygiene education classes, followed by 20-weeks of: 1) individually-timed BLT; and 2) individually-tailored PA promotion']","['objective-estimate of sleep', 'MW8-measured sleep duration, fragmentation index, wake-after-sleep-onset, latency, and PSQI-measured subjective sleep quality', 'MW8 measured sleep efficiency', 'Sleep and Cognitive Function', 'sleep efficiency measured using the MotionWatch8© (MW8', 'subjective sleep quality']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",96.0,0.0385551,"However, INT participants reported significantly better subjective sleep quality at 24-weeks (estimated mean difference: -1.39; 95% CI [-2.72, -0.06]) compared to CON.
","[{'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Falck', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Davis', 'Affiliation': 'Faculty of Management, University of British Columbia-Okanagan Campus, Kelowna, British Columbia, Canada.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Best', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Patrick C Y', 'Initials': 'PCY', 'LastName': 'Chan', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Li', 'Affiliation': 'Arthritis Research Canada, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Wyrough', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kimberly J', 'Initials': 'KJ', 'LastName': 'Bennett', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Backhouse', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Aging, Mobility, and Cognitive Neuroscience Lab, Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200383']
3236,32444567,A randomized controlled trial of restricted versus standard fluid management in late preterm and term infants with transient tachypnea of the newborn.,"BACKGROUND


Transient tachypnea of the newborn(TTNB) is the most common respiratory morbidity in late preterm and term babies and ispathophysiologically related to delayed lung fluid clearance after birth. Mimicking low physiological fluid intake in the initial period of life may accelerate the recovery from TTNB. In a randomized controlled trial, we compared the roles of restricted versus standard fluid management in babies with TTNB requiring respiratory support.
METHODS


This parallel group,non-blinded, stratified randomized controlled trial was conducted in a level III neonatal unit of eastern India. Late preterm and term babies with TTNB requiring continuous positive airway pressure (CPAP) were randomly allocated to standard and restricted fluid arms for the first 72 hours (hrs). Primary outcome was CPAP duration.
RESULTS


In total, 100 babies were enrolled in this study with 50 babies in each arm. CPAP duration was significantly less in the restricted arm (48[42, 54] hrs vs 54[48,72] hrs, p = 0.002). However, no difference was observed in the incidence of CPAP failure between the two arms. In the subgroup analysis, the benefit ofreduced CPAP duration persisted in late preterm but not in term infants. However, the effect was not significant in the late preterm babies exposed to antenatal steroid.
CONCLUSION


This trial demonstrated the safety and effectiveness of restrictive fluid strategy in reducing CPAP duration in late preterm and term babies with TTNB. Late preterm babies, especially those not exposed to antenatal steroid were the most benefitted by this strategy.",2020,"However, no difference was observed in the incidence of CPAP failure between the two arms.","['100 babies were enrolled in this study with 50 babies in each arm', 'late preterm and term babies with TTNB', 'babies with TTNB requiring respiratory support', 'late preterm and term infants with transient tachypnea of the newborn', 'level III neonatal unit of eastern India', 'Late preterm and term babies with TTNB requiring continuous positive airway pressure (CPAP']","['standard fluid management', 'restrictive fluid strategy']","['CPAP failure', 'CPAP duration']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0158940', 'cui_str': 'Transitory tachypnea of newborn'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",100.0,0.255152,"However, no difference was observed in the incidence of CPAP failure between the two arms.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sardar', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research, Kolkata, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pal', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research, Kolkata, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mishra', 'Affiliation': 'Department of Physiology, Ananda Mohan College, University of Calcutta, Kolkata, India.'}]",Journal of neonatal-perinatal medicine,['10.3233/NPM-190400']
3237,32444570,Effects of robot-assisted gait training alongside conventional therapy on the development of walking in children with cerebral palsy.,"PURPOSE


To investigate the effects of robot-assisted gait training (RAGT) alongside conventional therapy on the standing and walking abilities of children with cerebral palsy (CP).
METHODS


The study sample consisted of children (aged 4-18 years) with CP whose gross motor function classification system (GMFCS) was at levels I-V. In total, 75 children with CP were evaluated and 38 patients completed the study. Patients were divided into two groups as GMFCS levels I-III (Group 1) and levels IV-V (Group 2). RAGT (30 min/session) and conventional physiotherapy (30 min/session) were applied together in the treatment. The treatment duration was 60 min per session, 3 or 4 sessions per week, for a total of 30 sessions over 8-10 weeks. 10-meter walk test (10MWT), 6-min walk test (6MinWT), gross motor functional measurement 66 (GMFM66) -D, and -E tests were performed.
RESULTS


We showed that in both groups of CP patients (mild-moderate and severe), meaningful improvements were seen in the standing (D) and walking (E) sections of GMFM-66 after treatment. When we compared the post-treatment changes in 10-m walk test, 6-min walk test, GMFM66-D, and -E between Groups 1 and 2, we noted that the improvements were statistically significant in favor of Group 1 (p< 0.01).
CONCLUSION


RAGT in combination with a conventional treatment program was significantly associated with improvements in the standing and walking abilities of children with mild to moderate CP (GMFCS levels I-III).",2020,"CONCLUSION


RAGT in combination with a conventional treatment program was significantly associated with improvements in the standing and walking abilities of children with mild to moderate CP (GMFCS levels I-III).","['children with cerebral palsy (CP', 'children (aged 4-18 years) with CP whose gross motor function classification system (GMFCS) was at levels I-V', 'children with cerebral palsy', '75 children with CP were evaluated and 38 patients completed the study']","['robot-assisted gait training (RAGT) alongside conventional therapy', 'conventional physiotherapy', 'RAGT', 'robot-assisted gait training alongside conventional therapy']","['10-m walk test, 6-min walk test, GMFM66-D, and -E', 'standing and walking abilities', '10-meter walk test (10MWT), 6-min walk test (6MinWT), gross motor functional measurement 66 (GMFM66) -D, and -E tests']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C1275991', 'cui_str': 'E test'}]",75.0,0.0159701,"CONCLUSION


RAGT in combination with a conventional treatment program was significantly associated with improvements in the standing and walking abilities of children with mild to moderate CP (GMFCS levels I-III).","[{'ForeName': 'Hamza', 'Initials': 'H', 'LastName': 'Sucuoglu', 'Affiliation': ''}]",Journal of pediatric rehabilitation medicine,['10.3233/PRM-180541']
3238,32444573,"Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT).","PURPOSE


To investigate the effectiveness of outpatient robot-assisted gait training (RAGT) in ambulatory children with spastic cerebral palsy.
METHODS


Children were randomized to two different intervention sequences within a pragmatic crossover design. They performed five weeks of RAGT (3 sessions per week) and five weeks of usual care (UC). Dimension E of the Gross Motor Function Measure - 88 (GMFM E) was the primary outcome as well as Dimension D (GMFM D), and timed walking tests were assessed before and after each treatment sequence and after a 5 - week follow - up.
RESULTS


The trial was stopped early because of recruitment problems. We included 16 children with a mean age of 11.3 years (6.0-15.3 years). GMFM E median (IQR) change scores were - 0.7 (-2.8 to 3.5) after RAGT and 0 (-2.4 to 2.4) after UC. Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow - up, or carry - over effects observable.
CONCLUSIONS


RAGT as a single intervention was not effective in improving walking abilities in the included children. It should be embedded in a holistic treatment approach, as it cannot cover all aspects relevant to gait. Furthermore, children's personalized rehabilitation goals should be carefully monitored with individualized measurement instruments.",2020,"Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow - up, or carry - over effects observable.
","['children with cerebral palsy (PeLoGAIT', '16 children with a mean age of 11.3 years (6.0-15.3 years', 'ambulatory children with spastic cerebral palsy', 'Children']","['outpatient robot-assisted gait training (RAGT', 'robot-assisted gait training', 'RAGT']","['Dimension D (GMFM D), and timed walking tests', 'walking abilities', 'GMFM E median (IQR) change scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",16.0,0.0332735,"Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow - up, or carry - over effects observable.
","[{'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Ammann-Reiffer', 'Affiliation': ""Swiss Children's Rehab, Research Department, University Children's Hospital Zurich, Eleonore Foundation, Affoltern am Albis, Switzerland.""}, {'ForeName': 'Caroline H G', 'Initials': 'CHG', 'LastName': 'Bastiaenen', 'Affiliation': 'Functioning and Rehabilitation, CAPHRI, Department of Epidemiology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Andreas D', 'Initials': 'AD', 'LastName': 'Meyer-Heim', 'Affiliation': ""Swiss Children's Rehab, Research Department, University Children's Hospital Zurich, Eleonore Foundation, Affoltern am Albis, Switzerland.""}, {'ForeName': 'Hubertus J A', 'Initials': 'HJA', 'LastName': 'van Hedel', 'Affiliation': ""Swiss Children's Rehab, Research Department, University Children's Hospital Zurich, Eleonore Foundation, Affoltern am Albis, Switzerland.""}]",Journal of pediatric rehabilitation medicine,['10.3233/PRM-190614']
3239,32444619,Virtual reality clinical-experimental tests of compassion treatment techniques to reduce paranoia.,"Paranoia may build on negative beliefs held both about the self and others. Compassionate imagery may be one way of reducing such negative beliefs, and hence paranoia. Two studies tested this idea, one targeting compassion for the self and one targeting compassion for others. Two-hundred individuals from the general population scoring highly for paranoia were recruited. The studies used a randomised controlled experimental design, with embedded tests for mediation. Study one targeted self-compassion via creation of a compassionate coach (CC) image. Study two targeted compassion for others via loving kindness meditation (LKM). Individuals repeatedly entered neutral virtual reality social environments. Changes in compassion and paranoia were assessed. Compared to controls, the CC group increased in self-compassion (group difference = 2.12, C.I. = 1.57;2.67, p = <0.0001, d = 1.4) and decreased in paranoia (group difference = -1.73, C.I. = -2.48; -0.98, p = <0.0001, d = 0.8). Change in self-compassion explained 57% of change in paranoia. Compared to controls, the LKM group increased their compassion for others (group difference = 3.26, C.I. = 2.72;3.80, p = <0.0001, d = 1.7), and decreased in paranoia (group difference = -1.70, C.I. = -2.50; -0.89, p = <0.0001, d = 0.8). Change in compassion for others explained 67% of change in paranoia. Targeting negative beliefs about the self and others using compassionate imagery causes reductions in paranoia. Tests in clinical populations are indicated.",2020,"Compared to controls, the LKM group increased their compassion for others (group difference = 3.26, C.I. = 2.72;3.80, p = <0.0001, d = 1.7), and decreased in paranoia (group difference = -1.70, C.I. = -2.50; -0.89, p = <0.0001, d = 0.8).","['Two-hundred individuals from the general population scoring highly for paranoia were recruited', 'Individuals repeatedly entered neutral virtual reality social environments']",['LKM'],"['paranoia', 'Change in compassion', 'self-compassion', 'compassion']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0037414', 'cui_str': 'Social context'}]","[{'cui': 'C0024028', 'cui_str': 'Love'}]","[{'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",200.0,0.084631,"Compared to controls, the LKM group increased their compassion for others (group difference = 3.26, C.I. = 2.72;3.80, p = <0.0001, d = 1.7), and decreased in paranoia (group difference = -1.70, C.I. = -2.50; -0.89, p = <0.0001, d = 0.8).","[{'ForeName': 'Poppy', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK. poppy.brown@psych.ox.ac.uk.'}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Waite', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Rovira', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'School of Chemistry, University of Bristol, Bristol, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}]",Scientific reports,['10.1038/s41598-020-64957-7']
3240,32444629,Quadratus Lumborum Block As A Single Anesthetic Method For Laparoscopic Totally Extraperitoneal (Tep) Inguinal Hernia Repair: A Randomized Clinical Trial.,"Minimally invasive surgery for inguinal hernia repair is advantageous in terms of return to usual activities and lower rates of chronic pain; however, it requires general anesthesia. This study sought to analyze the benefits of ultrasound guided locoregional anesthesia of the quadratus lumborum muscle (QL block) as a single anesthetic technique for endoscopic totally extraperitoneal (TEP) inguinal hernia repair with regard to postoperative pain, length of hospital stay, and hospital cost. A total of 46 patients, aged 18 to 80 years, with unilateral inguinal hernia, one group that received general anesthesia and one that received sedation and QL block for TEP inguinal hernia repair. In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia. Consequently, the former group showed a briefer median hospital stay (6 versus 24 hours, respectively). The anesthesia and hospital costs were also lower for the QL block group, with median reductions of 64.15% and 25%, respectively. QL block is a safe and effective option for patients undergoing TEP inguinal hernia repair, given the observed reduction in early postoperative pain, briefer hospital stay, and decreased anesthesia and hospital costs.",2020,In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia.,"['46 patients, aged 18 to 80 years, with unilateral inguinal hernia, one group that received', 'Tep) Inguinal Hernia Repair', 'patients undergoing TEP inguinal hernia repair']","['ultrasound guided locoregional anesthesia of the quadratus lumborum muscle (QL block', 'general anesthesia and one that received sedation and QL block for TEP inguinal hernia repair', 'Laparoscopic Totally Extraperitoneal', 'Minimally invasive surgery', 'QL block', 'endoscopic totally extraperitoneal (TEP) inguinal hernia repair']","['median pain score', 'Quadratus Lumborum Block', 'anesthesia and hospital costs', 'briefer median hospital stay', 'postoperative pain, length of hospital stay, and hospital cost', 'early postoperative pain, briefer hospital stay, and decreased anesthesia and hospital costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",46.0,0.130019,In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia.,"[{'ForeName': 'Murillo de Lima', 'Initials': 'ML', 'LastName': 'Favaro', 'Affiliation': 'Professor of General Surgery and Surgical Technique at the University Santo Amaro, São Paulo, Brazil. mlfavaro@prof.unisa.br.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Gabor', 'Affiliation': 'Professor of General Surgery and Surgical Technique at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Diogo Barros Florenzano', 'Initials': 'DBF', 'LastName': 'Souza', 'Affiliation': 'Professor of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Anderson Alcoforado', 'Initials': 'AA', 'LastName': 'Araújo', 'Affiliation': 'Fellow of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Ana Luiza Castro', 'Initials': 'ALC', 'LastName': 'Milani', 'Affiliation': 'Fellow of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Marcelo Augusto Fontenelle', 'Initials': 'MAF', 'LastName': 'Ribeiro Junior', 'Affiliation': 'Full Professor of General Surgery at the University Santo Amaro, São Paulo, Brazil.'}]",Scientific reports,['10.1038/s41598-020-65604-x']
3241,32444670,A new approach to prevent cervical stenosis in postmenopausal women after loop electrosurgical excision procedure: a randomized controlled trial.,"To determine whether regular cervical dilatation is effective for preventing cervical stenosis, and to identify the associated risk factors, in postmenopausal women after LEEP. This was a prospective randomized clinical trial in postmenopausal women who underwent LEEP at our hospital between August 2018 and May 2019. Patients who met the study criteria were randomly allocated to three groups: control group (without any intervention), intervention group A (underwent cervical dilatation at the 3 rd , 5 th , and 8 th  week after LEEP) and intervention group B (underwent cervical dilatation at the 4 th , 8 th , and 12 th  week after LEEP). A colposcopic follow-up examination was conducted at 6 months after LEEP to determine the incidence of cervical stenosis. A total of 404 postmenopausal women were found to be finally eligible for the study. The rate of cervical stenosis in the control group was significantly higher than that in the intervention group, and the rate in group A was significantly lower than that in group B. We found regular dilatation after LEEP in postmenopausal women can prevent cervical stenosis. Further, the 3rd, 5th, and 8th weeks after LEEP are optimal time points. Finally, LEEP frequency and resection depth are significant risk factors and can be used to screen postmenopausal women at risk for cervical stenosis after LEEP.",2020,"The rate of cervical stenosis in the control group was significantly higher than that in the intervention group, and the rate in group A was significantly lower than that in group","['screen postmenopausal women at risk for cervical stenosis after LEEP', 'Patients who met the study criteria', 'postmenopausal women after loop electrosurgical excision procedure', 'postmenopausal women', '404 postmenopausal women were found to be finally eligible for the study', 'postmenopausal women who underwent LEEP at our hospital between August 2018 and May 2019', 'postmenopausal women after LEEP']","['regular cervical dilatation', 'control group (without any intervention), intervention group A (underwent cervical dilatation']",['rate of cervical stenosis'],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0269199', 'cui_str': 'Stenosis of cervix'}, {'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0269199', 'cui_str': 'Stenosis of cervix'}]",404.0,0.0439457,"The rate of cervical stenosis in the control group was significantly higher than that in the intervention group, and the rate in group A was significantly lower than that in group","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Zhunan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. dr.wudan@163.com.'}]",Scientific reports,['10.1038/s41598-020-65170-2']
3242,32444867,Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis.,"The randomized, phase 3 ICARIA-MM study investigated isatuximab (Isa) with pomalidomide and dexamethasone (Pd) versus Pd in patients with relapsed/refractory multiple myeloma and ≥2 prior lines. This prespecified subgroup analysis examined efficacy in patients with renal impairment (RI; estimated glomerular filtration rate <60 mL/min/1.73 m²). Isa 10 mg/kg was given intravenously once weekly in cycle 1, and every 2 weeks in subsequent 28-day cycles. Patients received standard doses of Pd. Median progression-free survival (PFS) for patients with RI was 9.5 months with Isa-Pd (n = 55) and 3.7 months with Pd (n = 49; hazard ratio [HR] 0.50; 95% confidence interval [CI], 0.30-0.85). Without RI, median PFS was 12.7 months with Isa-Pd (n = 87) and 7.9 months with Pd (n = 96; HR 0.58; 95% CI, 0.38-0.88). The overall response rate (ORR) with and without RI was higher with Isa-Pd (56 and 68%) than Pd (25 and 43%). Complete renal response rates were 71.9% (23/32) with Isa-Pd and 38.1% (8/21) with Pd; these lasted ≥60 days in 31.3% (10/32) and 19.0% (4/21) of patients, respectively. Isa pharmacokinetics were comparable between the subgroups, suggesting no need for dose adjustment in patients with RI. In summary, the addition of Isa to Pd improved PFS, ORR and renal response rates.",2020,"Complete renal response rates were 71.9% (23/32) with Isa-Pd and 38.1% (8/21) with Pd; these lasted ≥60 days in 31.3% (10/32) and 19.0% (4/21) of patients, respectively.","['relapsed/refractory multiple myeloma patients with renal impairment', 'patients with relapsed/refractory multiple myeloma and ≥2 prior lines', 'patients with renal impairment (RI; estimated glomerular filtration rate <60\u2009mL/min/1.73\u2009m²']","['Isatuximab plus pomalidomide and dexamethasone', 'standard doses of Pd', 'isatuximab (Isa) with pomalidomide and dexamethasone (Pd) versus Pd']","['PFS, ORR and renal response rates', 'overall response rate (ORR) with and without RI', 'Median progression-free survival (PFS', 'Complete renal response rates', 'median PFS']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C4330502', 'cui_str': 'isatuximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.115923,"Complete renal response rates were 71.9% (23/32) with Isa-Pd and 38.1% (8/21) with Pd; these lasted ≥60 days in 31.3% (10/32) and 19.0% (4/21) of patients, respectively.","[{'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens School of Medicine, Athens, Greece. mdimop@med.uoa.gr.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': 'Department of Hematology, Centre Hospitalier Universitaire, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University of Nantes, Nantes, France.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Oncology-Hematology, Santa Maria Hospital, University of Perugia, Terni, Italy.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Harrison', 'Affiliation': 'Clinical Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Miles Prince', 'Affiliation': 'Epworth Healthcare, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Enrique M', 'Initials': 'EM', 'LastName': 'Ocio', 'Affiliation': 'Hospital Universitario Marqués de Valdecilla (IDIVAL), Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Assadourian', 'Affiliation': 'Sanofi R&D, Paris, France.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Campana', 'Affiliation': 'Sanofi-Genzyme Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Malinge', 'Affiliation': 'Aixial (for Sanofi), Boulogne-Billancourt, France.'}, {'ForeName': 'Dorothée', 'Initials': 'D', 'LastName': 'Sémiond', 'Affiliation': 'Sanofi R&D, Paris, France.'}, {'ForeName': 'Helgi', 'Initials': 'H', 'LastName': 'van de Velde', 'Affiliation': 'Sanofi-Genzyme Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Kwee', 'Initials': 'K', 'LastName': 'Yong', 'Affiliation': 'Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK.'}]",Leukemia,['10.1038/s41375-020-0868-z']
3243,32444901,"A Randomized Controlled Trial of a Texting Intervention to Maintain Sexual Risk Reduction with Clients Among Female Sex Workers in Tijuana and Ciudad Juarez, Mexico.","Mobile phone technology may help sustain reductions in HIV/STI transmission risk behaviors among female sex workers (FSWs). We examined the efficacy of a text messaging intervention designed to maintain behavioral improvements in safer sex practices among 602 FSWs in Tijuana and Ciudad Juarez, Mexico. We hypothesized that FSWs who received brief risk reduction counseling and theory-based safer sex maintenance text messages over a 24-month period would have fewer incident HIV/STIs and report greater maintenance of safer sex practices compared to FSWs who received counseling and texts on maintaining general health. Theory-based texts did not change the odds of becoming infected with HIV/STIs in either study site. However, they did lead to significant, sustained protected sex in Tijuana. Theory-based text messaging interventions may help sustain reductions in sexual risk behavior among FSWs.Trial Registration Clinical Trials.gov. Identifier: NCT02447484.",2020,"We examined the efficacy of a text messaging intervention designed to maintain behavioral improvements in safer sex practices among 602 FSWs in Tijuana and Ciudad Juarez, Mexico.","['Clients Among Female Sex Workers in Tijuana and Ciudad Juarez, Mexico', 'female sex workers (FSWs', 'safer sex practices among 602 FSWs in Tijuana and Ciudad Juarez, Mexico']","['brief risk reduction counseling and theory-based safer sex maintenance text messages', 'Texting Intervention', 'text messaging intervention']",[],"[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]",[],,0.0894895,"We examined the efficacy of a text messaging intervention designed to maintain behavioral improvements in safer sex practices among 602 FSWs in Tijuana and Ciudad Juarez, Mexico.","[{'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Patterson', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, Mail Code 0680, La Jolla, CA, 92093, USA. tpatterson@ucsd.edu.'}, {'ForeName': 'Eileen V', 'Initials': 'EV', 'LastName': 'Pitpitan', 'Affiliation': 'School of Social Work, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Pines', 'Affiliation': 'Division of Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Shirley J', 'Initials': 'SJ', 'LastName': 'Semple', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, Mail Code 0680, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Harvey-Vera', 'Affiliation': 'Division of Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Depp', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, Mail Code 0680, La Jolla, CA, 92093, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Moore', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, Mail Code 0680, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Martinez', 'Affiliation': 'Federación Méxicana de Asociaciones Privadas (FEMAP), Ciudad Juarez, Chihuahua, Mexico.'}, {'ForeName': 'M Gudelia', 'Initials': 'MG', 'LastName': 'Rangel', 'Affiliation': 'US-Mexico Border Health Commission, Tijuana, Baja California, Mexico.'}, {'ForeName': 'Steffanie A', 'Initials': 'SA', 'LastName': 'Strathdee', 'Affiliation': 'Division of Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02930-1']
3244,32444980,Randomized prospective trial of fractionated stereotactic radiosurgery with chemotherapy versus chemotherapy alone for bevacizumab-resistant high-grade glioma.,"PURPOSE


Outcomes for patients with recurrent high-grade glioma (HGG) progressing on bevacizumab (BEV) are dismal. Fractionated stereotactic radiosurgery (FSRS) has been shown to be feasible and safe when delivered in this setting, but prospective evidence is lacking. This single-institution randomized trial compared FSRS plus BEV-based chemotherapy versus BEV-based chemotherapy alone for BEV-resistant recurrent malignant glioma.
MATERIALS AND METHODS


HGG patients on BEV with tumor progression after 2 previous treatments were randomized to 1) FSRS plus BEV-based chemotherapy or 2) BEV-based chemotherapy with irinotecan, etoposide, temozolomide, or carboplatin. FSRS was delivered as 32 Gy (8 Gy × 4 fractions within 2 weeks) to the gross target volume and 24 Gy (6 Gy × 4 fractions) to the clinical target volume (fluid-attenuated inversion recovery abnormality). The primary endpoints were local control (LC) at 2 months and progression-free survival (PFS).
RESULTS


Of the 35 patients enrolled, 29 had glioblastoma (WHO IV) and 6 had anaplastic glioma (WHO III). The median number of prior recurrences was 3. Patients treated with FSRS had significantly improved PFS (5.1 vs 1.8 months, P < .001) and improved LC at 2 months (82% [14/17] vs 27% [4/15], P = .002). The overall median survival was 6.6 months (7.2 months with FSRS vs 4.8 months with chemotherapy alone, P = .11).
CONCLUSIONS


FSRS combined with BEV-based chemotherapy in recurrent HGG patients progressing on BEV is feasible and improves LC and PFS when compared to treatment with BEV-based chemotherapy alone.",2020,"Patients treated with FSRS had significantly improved PFS (5.1 vs 1.8 months, P < .001) and improved LC at 2 months (82% [14/17] vs 27% [4/15], P = .002).","['6 had anaplastic glioma (WHO III', '35 patients enrolled, 29 had glioblastoma (WHO IV) and', 'HGG patients on BEV with tumor progression after 2 previous treatments', 'resistant high-grade glioma', 'patients with recurrent high-grade glioma (HGG) progressing on']","['Fractionated stereotactic radiosurgery (FSRS', 'FSRS plus BEV-based chemotherapy or 2) BEV-based chemotherapy with irinotecan, etoposide, temozolomide, or carboplatin', 'bevacizumab (BEV', 'fractionated stereotactic radiosurgery with chemotherapy versus chemotherapy', 'FSRS combined with BEV-based chemotherapy', 'FSRS plus BEV-based chemotherapy versus BEV-based chemotherapy alone', 'FSRS', 'bevacizumab']","['median number of prior recurrences', 'local control (LC) at 2\xa0months and progression-free survival (PFS', 'PFS', 'overall median survival']","[{'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0085203', 'cui_str': 'Radiosurgery'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",35.0,0.0793639,"Patients treated with FSRS had significantly improved PFS (5.1 vs 1.8 months, P < .001) and improved LC at 2 months (82% [14/17] vs 27% [4/15], P = .002).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bergman', 'Affiliation': 'Department of Radiation Oncology, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Modh', 'Affiliation': 'Department of Radiation Oncology, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Lonni', 'Initials': 'L', 'LastName': 'Schultz', 'Affiliation': 'Department of Neurosurgery, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Snyder', 'Affiliation': 'Department of Neurosurgery, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Mikkelsen', 'Affiliation': 'Department of Neurosurgery, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Department of Radiation Oncology, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Ryu', 'Affiliation': 'Department of Radiation Oncology, Stony Brook University Hospital, 101 Nicolls Road, Stony Brook, NY, 11794, USA.'}, {'ForeName': 'M Salim', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Radiation Oncology, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Walbert', 'Affiliation': 'Department of Neurosurgery, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA. twalber1@hfhs.org.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03526-4']
3245,32444994,"""BAX602"" in Preventing Surgical Adhesion after Extracorporeal Ventricular Assist Device Implantation for Refractory Congestive Heart Failure: Study Protocol for a Multicenter Randomized Clinical Trial.","BACKGROUND


The high surgical risk in redo cardiac surgery is largely attributed to adhesions around the epicardium and the great vessels. BAX602 is an adhesion prevention reagent composed of two synthetic polyethylene glycols. Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery. The present study aims to evaluate the safety and effectiveness of BAX602 spray in patients undergoing extracorporeal ventricular assist device implantation surgery to treat refractory congestive heart failure.
METHODS AND DESIGN


This investigator-initiated, multicenter, pivotal, two-arm, open-label, randomized trial will include a total of 30 patients. The primary outcome measure is the severity of adhesions, which will be evaluated during re-sternotomy surgery performed 2-12 weeks after the primary extracorporeal ventricular assist device implantation surgery. The adhesion severity will be evaluated at five predefined sites using a four-grade adhesion evaluation score (0 = no adhesion; 1 = filmy and avascular adhesion; 2 = dense/vascular adhesion; 3 = cohesive adhesion). This measure will be summarized in two ways to evaluate the effect of BAX602: (1) the total score of the severity of adhesions at all five sites (ranging from 0 to 15), and (2) the total number of sites with dense/vascular or cohesive adhesions (ranging from 0 to 5).
ETHICS AND DISSEMINATION


The study findings will be disseminated at regional, national, and international conferences and through peer-reviewed scientific journals.
TRIAL REGISTRATION


The trial was registered in the UMIN Clinical Trials Registry (UMIN-CTR: UMIN000038998) on 6 January 2020.",2020,Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery.,"['Refractory Congestive Heart Failure', '30 patients', 'patients undergoing']","['Extracorporeal Ventricular Assist Device Implantation', 'BAX602 spray', 'BAX602', 'extracorporeal ventricular assist device implantation surgery']","['safety and effectiveness', 'severity of adhesions, which will be evaluated during re-sternotomy surgery', 'adhesion severity']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0397128', 'cui_str': 'Implantation of ventricular assist device'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",30.0,0.202345,Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery.,"[{'ForeName': 'Satsuki', 'Initials': 'S', 'LastName': 'Fukushima', 'Affiliation': 'Department of Cardiac Surgery, National Cerebral and Cardiovascular Center, 6-1 Kishibeshimmachi, Suita, Osaka, 564-8565, Japan. s.fukushima@ncvc.go.jp.'}, {'ForeName': 'Koko', 'Initials': 'K', 'LastName': 'Asakura', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Hamasaki', 'Affiliation': 'The Biostatistics Center and Department of Biostatistics and Bioinformatics, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Onda', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shiose', 'Affiliation': 'Department of Cardiovascular Surgery, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiac Surgery, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Norihide', 'Initials': 'N', 'LastName': 'Fukushima', 'Affiliation': 'Department of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Cardiac Surgery, National Cerebral and Cardiovascular Center, 6-1 Kishibeshimmachi, Suita, Osaka, 564-8565, Japan.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-06990-2']
3246,28398129,Using Tai Chi to Reduce Fall Risk Factors Among Older Adults: An Evaluation of a Community-Based Implementation.,"This study aimed to evaluate a community-based implementation of an evidence-based fall prevention program, in which 131 individuals participated in Tai Chi: Moving for Better Balance. Self-report and functional performance assessments included demographics, health and fall history, the Activities-Specific Balance Scale, the Timed Up and Go test, and the Functional Reach test. Pre-post scores were compared with the Wilcoxon signed rank test. The mostly female participants were 73 years old, on average. At baseline, 18% reported being afraid or very afraid of falling, and 18% had fallen in the past 6 months. At follow-up, there was significant improvement in Timed Up and Go ( p < .001), Functional Reach ( p < .01), and Activities-Specific Balance Scale scores ( p < .01). These results demonstrate that a 12-week evidence-based Tai Chi program can be feasibly implemented by novice instructors, is well-received by older adults, and can effectively reduce fall risk when implemented in community settings.",2019,"At follow-up, there was significant improvement in Timed Up and Go ( p < .001), Functional Reach ( p < .01), and Activities-Specific Balance Scale scores ( p < .01).","['Older Adults', '131 individuals participated in Tai Chi', 'mostly female participants were 73 years old, on average']","['Tai Chi', 'community-based implementation of an evidence-based fall prevention program']","['Fall Risk Factors', 'Activities-Specific Balance Scale scores', 'Timed Up and Go', 'demographics, health and fall history, the Activities-Specific Balance Scale, the Timed Up and Go test, and the Functional Reach test', 'Functional Reach']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}]",131.0,0.0122959,"At follow-up, there was significant improvement in Timed Up and Go ( p < .001), Functional Reach ( p < .01), and Activities-Specific Balance Scale scores ( p < .01).","[{'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Gallant', 'Affiliation': '1 University at Albany, State University of New York, Rensselaer, NY, USA.'}, {'ForeName': 'Meaghan', 'Initials': 'M', 'LastName': 'Tartaglia', 'Affiliation': '2 New York State Department of Health, Albany, NY, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hardman', 'Affiliation': '3 Safe States Alliance, Atlanta, GA, USA.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Burke', 'Affiliation': '4 Albany Medical College, NY, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464817703004']
3247,30315394,Alterations of the brain network in idiopathic rapid eye movement sleep behavior disorder: structural connectivity analysis.,"PURPOSE


To evaluate and compare structural connectivity using graph theoretical analysis in patients with idiopathic rapid eye movement sleep behavior disorder (iRBD) and healthy subjects.
METHODS


Ten consecutive patients with iRBD were recruited from a single tertiary hospital. All patients had normal brain magnetic resonance imaging results on visual inspection. They did not have any other neurological disorder. Control subjects were also enrolled. All subjects underwent three-dimensional volumetric T1-weighted imaging. Absolute structural volumes were calculated using FreeSurfer image analysis software. Structural volume and connectivity analyses were performed with Brain Analysis using Graph Theory.
RESULTS


Compared to healthy controls, patients with iRBD showed significant alterations in cortical and subcortical volumes, showing increased volumes of frontal cortex, thalamus, and caudate nucleus. In addition, patients with iRBD exhibited significantly different structural connectivity compared to healthy controls. In measures of global network, average degree, global efficiency, and local efficiency were decreased whereas characteristic path length was increased in iRBD patients. In measures of local network, there was significant hub reorganization in patients with iRBD. Betweenness centrality of caudate nucleus and frontal cortex was increased in patients with iRBD.
CONCLUSIONS


This is the first study to report that structural volume and connectivity in patients with iRBD are significantly different from those in healthy controls. iRBD patients exhibited disrupted topological disorganization of the global brain network and hub reorganization. These alterations are implicated in the pathogenesis of iRBD. They might be potential biomarkers of iRBD.",2019,"Compared to healthy controls, patients with iRBD showed significant alterations in cortical and subcortical volumes, showing increased volumes of frontal cortex, thalamus, and caudate nucleus.","['patients with iRBD', 'Ten consecutive patients with iRBD were recruited from a single tertiary hospital', 'idiopathic rapid eye movement sleep behavior disorder', 'patients with idiopathic rapid eye movement sleep behavior disorder (iRBD) and healthy subjects']",[],"['cortical and subcortical volumes', 'global network, average degree, global efficiency, and local efficiency', 'characteristic path length', 'Absolute structural volumes', 'structural connectivity', 'volumes of frontal cortex, thalamus, and caudate nucleus', 'visual inspection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0007461', 'cui_str': 'Caudate nucleus structure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}]",10.0,0.0341579,"Compared to healthy controls, patients with iRBD showed significant alterations in cortical and subcortical volumes, showing increased volumes of frontal cortex, thalamus, and caudate nucleus.","[{'ForeName': 'Kang Min', 'Initials': 'KM', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Ho-Joon', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Byung In', 'Initials': 'BI', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Sung Eun', 'Initials': 'SE', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea. epidoc@inje.ac.kr.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-018-1737-0']
3248,30685685,Survival and prognosis with osteosarcoma: outcomes in more than 2000 patients in the EURAMOS-1 (European and American Osteosarcoma Study) cohort.,"BACKGROUND


High-grade osteosarcoma is a primary malignant bone tumour mainly affecting children and young adults. The European and American Osteosarcoma Study (EURAMOS)-1 is a collaboration of four study groups aiming to improve outcomes of this rare disease by facilitating randomised controlled trials.
METHODS


Patients eligible for EURAMOS-1 were aged ≤40 years with M0 or M1 skeletal high-grade osteosarcoma in which case complete surgical resection at all sites was deemed to be possible. A three-drug combination with methotrexate, doxorubicin and cisplatin was defined as standard chemotherapy, and between April 2005 and June 2011, 2260 patients were registered. We report survival outcomes and prognostic factors in the full cohort of registered patients.
RESULTS


For all registered patients at a median follow-up of 54 months (interquartile range: 38-73) from biopsy, 3-year and 5-year event-free survival were 59% (95% confidence interval [CI]: 57-61%) and 54% (95% CI: 52-56%), respectively. Multivariate analyses showed that the most adverse factors at diagnosis were pulmonary metastases (hazard ratio [HR] = 2.34, 95% CI: 1.95-2.81), non-pulmonary metastases (HR = 1.94, 95% CI: 1.38-2.73) or an axial skeleton tumour site (HR = 1.53, 95% CI: 1.10-2.13). The histological subtypes telangiectatic (HR = 0.52, 95% CI: 0.33-0.80) and unspecified conventional (HR = 0.67, 95% CI: 0.52-0.88) were associated with a favourable prognosis compared with chondroblastic subtype. The 3-year and 5-year overall survival from biopsy were 79% (95% CI: 77-81%) and 71% (95% CI: 68-73%), respectively. For patients with localised disease at presentation and in complete remission after surgery, having a poor histological response was associated with worse outcome after surgery (HR = 2.13, 95% CI: 1.76-2.58). In radically operated patients, there was no good evidence that axial tumour site was associated with worse outcome.
CONCLUSIONS


In conclusion, data from >2000 patients registered to EURAMOS-1 demonstrated survival rates in concordance with institution- or group-level osteosarcoma trials. Further efforts are required to drive improvements for patients who can be identified to be at higher risk of adverse outcome. This trial reaffirms known prognostic factors, and owing to the large numbers of patients registered, it sheds light on some additional factors to consider.",2019,"The histological subtypes telangiectatic (HR = 0.52, 95% CI: 0.33-0.80) and unspecified conventional (HR = 0.67, 95% CI: 0.52-0.88) were associated with a favourable prognosis compared with chondroblastic subtype.","['April 2005 and June 2011, 2260 patients were registered', 'full cohort of registered patients', 'children and young adults', 'Patients eligible for EURAMOS-1 were aged ≤40 years with M0 or M1 skeletal high-grade osteosarcoma in which case complete surgical resection at all sites was deemed to be possible', '2000 patients in the EURAMOS-1 (European and American Osteosarcoma Study) cohort']","['methotrexate, doxorubicin and cisplatin']","['3-year and 5-year overall survival', 'biopsy, 3-year and 5-year event-free survival', 'histological subtypes telangiectatic', 'survival rates']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",2260.0,0.415819,"The histological subtypes telangiectatic (HR = 0.52, 95% CI: 0.33-0.80) and unspecified conventional (HR = 0.67, 95% CI: 0.52-0.88) were associated with a favourable prognosis compared with chondroblastic subtype.","[{'ForeName': 'Sigbjørn', 'Initials': 'S', 'LastName': 'Smeland', 'Affiliation': 'SSG Oslo University Hospital and Scandinavian Sarcoma Group and Institute for Clinical Medicine, University of Oslo, Norway. Electronic address: ssm@ous-hf.no.'}, {'ForeName': 'Stefan S', 'Initials': 'SS', 'LastName': 'Bielack', 'Affiliation': 'COSS Klinikum Stuttgart - Olgahospital Stuttgart, Germany.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Whelan', 'Affiliation': 'EOI University College Hospital, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'COG IWK Health Center, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Pancras', 'Initials': 'P', 'LastName': 'Hogendoorn', 'Affiliation': 'TMG Path Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Krailo', 'Affiliation': ""COG Children's Oncology Group, Arcadia, CA, USA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gorlick', 'Affiliation': 'COG the University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Janeway', 'Affiliation': 'COG Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Ingleby', 'Affiliation': 'CDC MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Anninga', 'Affiliation': 'EOI, Netherlands.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Antal', 'Affiliation': 'COSS Semmelweis Egyetem Budapest, Budapest, Hungary.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Arndt', 'Affiliation': 'COG Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ken L B', 'Initials': 'KLB', 'LastName': 'Brown', 'Affiliation': 'COG University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Trude', 'Initials': 'T', 'LastName': 'Butterfass-Bahloul', 'Affiliation': 'EISD Centre for Clinical Trials, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Calaminus', 'Affiliation': 'QLCC Pädiatrische Hämatologie und Onkologie, Universitätsklinikum Bonn, Bonn, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Capra', 'Affiliation': ""EOI Our Lady's Children's Hospital, Dublin, Ireland.""}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Dhooge', 'Affiliation': 'EOI University Hospital Ghent, Gent, Belgium.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'SSG Lund University, Lund, Sweden.'}, {'ForeName': 'Adrienne M', 'Initials': 'AM', 'LastName': 'Flanagan', 'Affiliation': 'EOI Royal National Orthopaedic Hospital, Stanmore; Cancer Institute, University College London, London, UK.'}, {'ForeName': 'Godehard', 'Initials': 'G', 'LastName': 'Friedel', 'Affiliation': 'COSS Klinik Schillerhöhe - Thoraxchirurgie Gerlingen, Germany.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Gebhardt', 'Affiliation': 'COG Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'EOI Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldsby', 'Affiliation': 'COG UCSF Medical Center-Mission Bay, Pediatric Oncology, San Francisco, CA, USA.'}, {'ForeName': 'Holcombe E', 'Initials': 'HE', 'LastName': 'Grier', 'Affiliation': 'COG Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grimer', 'Affiliation': 'EOI Royal Orthopaedic Hospital, Birmingham, UK.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': 'COG University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hecker-Nolting', 'Affiliation': 'COSS Klinikum Stuttgart - Olgahospital Stuttgart, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Sundby Hall', 'Affiliation': 'SSG Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Isakoff', 'Affiliation': ""COG Connecticut Children's Medical Center, Hartford, CT, USA.""}, {'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Jovic', 'Affiliation': 'CDC MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kühne', 'Affiliation': 'COSS Universitätsspital Basel, Basel, Switzerland.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Kager', 'Affiliation': 'COSS St. Anna Kinderspital /CCRI, Wien, Austria.'}, {'ForeName': 'Thekla', 'Initials': 'T', 'LastName': 'von Kalle', 'Affiliation': 'COSS Klinikum Stuttgart - Olgahospital Stuttgart, Germany.'}, {'ForeName': 'Edita', 'Initials': 'E', 'LastName': 'Kabickova', 'Affiliation': 'COSS University Hospital MOTOL, Praha, Czech Republic.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'COSS Medizinische Universität Wien, Vienna, Austria.'}, {'ForeName': 'Ching C', 'Initials': 'CC', 'LastName': 'Lau', 'Affiliation': 'COG Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Leavey', 'Affiliation': ""COG Southwestern and Children's Medical Center, Dallas, TX, USA.""}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Lessnick', 'Affiliation': ""COG Nationwide Children's Hospital and the Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': 'COG Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Mayer-Steinacker', 'Affiliation': 'COSS Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Meyers', 'Affiliation': 'COG Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Nagarajan', 'Affiliation': ""COG Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'R Lor', 'Initials': 'RL', 'LastName': 'Randall', 'Affiliation': 'COG Primary Childrens Hospital, The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'COSS Helios Kliniken Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Renard', 'Affiliation': 'EOI University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Rechnitzer', 'Affiliation': 'SSG Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Schwartz', 'Affiliation': 'COG the University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Strauss', 'Affiliation': 'EOI University College Hospital, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Teot', 'Affiliation': ""COG Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Timmermann', 'Affiliation': 'COSS Universitätsklinikum Essen, Essen, Germany.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'CDC MRC Clinical Trials Unit at UCL, London, UK. Electronic address: mrcctu.euramos@ucl.ac.uk.'}, {'ForeName': 'Neyssa', 'Initials': 'N', 'LastName': 'Marina', 'Affiliation': 'COG Five Prime Therapeutics, Inc South San Francisco, CA, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2018.11.027']
3249,30769293,The effect of direct hemoperfusion with polymyxin B immobilized cartridge on meropenem in critically ill patients requiring renal support.,"PURPOSE


To evaluate the effect of direct hemoperfusion with polymyxin B immobilized cartridge (DHP-PMX) on meropenem pharmacokinetics in critically ill patients with sepsis requiring continuous venovenous hemofiltration (CVVH).
MATERIAL AND METHODS


After intravenous infusion of 1 g meropenem over 3 h repeated every 8 h for at least 3 doses, 2 serial blood and ultrafiltration fluid samples were collected: one over a dose interval of meropenem with DHP-PMX therapy; and the other on the following day over a dose interval of meropenem with no DHP-PMX therapy. Meropenem concentrations were measured by high performance liquid chromatography. Pharmacokinetic parameters of meropenem and extraction ratio of DHP-PMX were calculated.
RESULTS


Mean AUC 0-8  of meropenem on DHP-PMX day was comparable to that of the DHP-PMX free day (285.2 ± 138.2 vs 297.8 ± 130.2 mg ∗ h/L; paired t-test, p = .618). No statistical significance of peak and trough concentrations, volume of distribution, sieving coefficient, or half-life were found. Extraction ratio of DHP-PMX on meropenem was 0 [0-0.03] and clearance by DHP-PMX was 0.04 [0-0.2] L/h which was not considered clinically significant.
CONCLUSIONS


No significant effect of DHP-PMX on meropenem pharmacokinetics was observed among severe sepsis/septic shock patients during CVVH treatment.
TRIAL REGISTRATION


Clinical Trial Registry detail: NCT registry: 02413541 (First registered March 3, 2015, last update October 16, 2017).",2019,"No significant effect of DHP-PMX on meropenem pharmacokinetics was observed among severe sepsis/septic shock patients during CVVH treatment.
","['critically ill patients requiring renal support', 'critically ill patients with sepsis requiring continuous venovenous hemofiltration (CVVH']","['direct hemoperfusion with polymyxin B immobilized cartridge (DHP-PMX', 'meropenem with DHP-PMX therapy', 'direct hemoperfusion with polymyxin B immobilized cartridge', 'meropenem with no DHP-PMX therapy', 'meropenem']","['Meropenem concentrations', 'clearance by DHP-PMX', 'Pharmacokinetic parameters of meropenem and extraction ratio of DHP-PMX', 'meropenem pharmacokinetics', 'peak and trough concentrations, volume of distribution, sieving coefficient, or half-life', 'Extraction ratio of DHP-PMX']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0472684', 'cui_str': 'Continuous venovenous hemofiltration'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0019063', 'cui_str': 'Hemoperfusion'}, {'cui': 'C0032535', 'cui_str': 'Polymyxin B'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0179630', 'cui_str': 'Cartridge'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0019063', 'cui_str': 'Hemoperfusion'}, {'cui': 'C0032535', 'cui_str': 'Polymyxin B'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0179630', 'cui_str': 'Cartridge'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",,0.119151,"No significant effect of DHP-PMX on meropenem pharmacokinetics was observed among severe sepsis/septic shock patients during CVVH treatment.
","[{'ForeName': 'Wanchana', 'Initials': 'W', 'LastName': 'Singhan', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmaceutical Science, Chulalongkorn University, Bangkok 10330, Thailand; Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand. Electronic address: wanchana.s@cmu.ac.th.'}, {'ForeName': 'Somratai', 'Initials': 'S', 'LastName': 'Vadcharavivad', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmaceutical Science, Chulalongkorn University, Bangkok 10330, Thailand. Electronic address: somratai.v@pharm.chula.ac.th.'}, {'ForeName': 'Nutthada', 'Initials': 'N', 'LastName': 'Areepium', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmaceutical Science, Chulalongkorn University, Bangkok 10330, Thailand. Electronic address: nutthada.a@pharm.chula.ac.th.'}, {'ForeName': 'Supeecha', 'Initials': 'S', 'LastName': 'Wittayalertpanya', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.'}, {'ForeName': 'Weerachai', 'Initials': 'W', 'LastName': 'Chaijamorn', 'Affiliation': 'Faculty of Pharmacy, Siam University, Bangkok 10160, Thailand. Electronic address: weerachai.cha@siam.edu.'}, {'ForeName': 'Nattachai', 'Initials': 'N', 'LastName': 'Srisawat', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand. Electronic address: drnattachai@yahoo.com.'}]",Journal of critical care,['10.1016/j.jcrc.2019.02.007']
3250,32442195,Antibody and cellular responses to HIV vaccine regimens with DNA plasmid as compared with ALVAC priming: An analysis of two randomized controlled trials.,"BACKGROUND


DNA plasmids promise a pragmatic alternative to viral vectors for prime-boost HIV-1 vaccines. We evaluated DNA plasmid versus canarypox virus (ALVAC) primes in 2 randomized, double-blind, placebo-controlled trials in southern Africa with harmonized trial designs. HIV Vaccine Trials Network (HVTN) 111 tested DNA plasmid prime by needle or needleless injection device (Biojector) and DNA plasmid plus gp120 protein plus MF59 adjuvant boost. HVTN 100 tested ALVAC prime and ALVAC plus gp120 protein plus MF59 adjuvant boost (same protein/adjuvant as HVTN 111) by needle.
METHODS AND FINDINGS


The primary endpoints for this analysis were binding antibody (bAb) responses to HIV antigens (gp120 from strains ZM96, 1086, and TV1; variable 1 and 2 [V1V2] regions of gp120 from strains TV1, 1086, and B.CaseA, as 1086 V1V2 and B.CaseA were correlates of risk in the RV144 efficacy trial), neutralizing antibody (nAb) responses to pseudoviruses TV1c8.2 and MW925.26, and cellular responses to vaccine-matched antigens (envelope [Env] from strains ZM96, 1086, and TV1; and Gag from strains LAI and ZM96) at month 6.5, two weeks after the fourth vaccination. Per-protocol cohorts included vaccine recipients from HVTN 100 (n = 186, 60% male, median age 23 years) enrolled between February 9, 2015, and May 26, 2015 and from HVTN 111 (n = 56, 48% male, median age 24 years) enrolled between June 21, 2016, and July 13, 2017. IgG bAb response rates were 100% to 3 Env gp120 antigens in both trials. Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001). Among positive responders, bAb net mean fluorescence intensity (MFI) was significantly higher with the DNA-primed regimen than ALVAC-primed for 1086 V1V2 (geometric mean [GM] 2,833.3 versus 1,200.9; ratio = 2.36, 95% CI 1.42-3.92, p < 0.001) and B.CaseA V1V2 (GM 2314.0 versus 744.6, ratio = 3.11, 95% CI 1.51-6.38, p = 0.002). nAb response rates were >98% in both trials, with significantly higher 50% inhibitory dilution (ID50) among DNA-primed positive responders (n = 53) versus ALVAC-primed (n = 182) to tier 1A MW965.26 (GM 577.7 versus 265.7, ratio = 2.17, 95% CI 1.67-2.83, p < 0.001) and to TV1c8.2 (GM 187.3 versus 100.4, ratio = 1.87, 95% CI 1.48-2.35, p < 0.001). CD4+ T-cell response rates were significantly higher with DNA plasmid prime via Biojector than ALVAC prime (91.4% versus 52.8%, difference = 38.6%, 95% CI 20.5%-56.6%, p < 0.001 for ZM96.C; 88.0% versus 43.1%, difference = 44.9%, 95% CI 26.7%-63.1%, p < 0.001 for 1086.C; 55.5% versus 2.2%, difference = 53.3%, 95% CI 23.9%-82.7%, p < 0.001 for Gag LAI/ZM96). The study's main limitations include the nonrandomized comparison of vaccines from 2 different trials, the lack of data on immune responses to other non-vaccine-matched antigens, and the uncertain clinical significance of the observed immunological effects.
CONCLUSIONS


In this study, we found that further investigation of DNA/protein regimens is warranted given enhanced immunogenicity to the V1V2 correlates of decreased HIV-1 acquisition risk identified in RV144, the only HIV vaccine trial to date to show any efficacy.",2020,"Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001).","['Per-protocol cohorts included vaccine recipients from HVTN 100', 'southern Africa with harmonized trial designs', 'n = 186, 60% male, median age 23 years) enrolled between February 9, 2015, and May 26, 2015 and from HVTN 111 (n = 56, 48% male, median age 24 years) enrolled between June 21, 2016, and July 13, 2017']","['placebo', 'ALVAC priming', 'DNA plasmid versus canarypox virus (ALVAC']","['IgG bAb response rates', 'nAb response rates', 'Response rates to V1V2', 'binding antibody (bAb) responses to HIV antigens (gp120 from strains ZM96, 1086, and TV1; variable 1 and 2 [V1V2] regions of gp120 from strains TV1, 1086, and B.CaseA, as 1086 V1V2 and B.CaseA were correlates of risk in the RV144 efficacy trial), neutralizing antibody (nAb) responses to pseudoviruses TV1c8.2 and MW925.26, and cellular responses to vaccine-matched antigens (envelope [Env] from strains ZM96, 1086, and TV1; and Gag from strains LAI and ZM96', 'bAb net mean fluorescence intensity (MFI', 'CD4+ T-cell response rates']","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001746', 'cui_str': 'Southern Africa'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0211671', 'cui_str': 'ALVAC vaccine'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0282472', 'cui_str': 'Canarypox virus'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0019686', 'cui_str': 'AIDS Antigens'}, {'cui': 'C0019691', 'cui_str': 'env Protein gp120, HIV'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0443021', 'cui_str': 'Lai'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",,0.585483,"Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001).","[{'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Moodie', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.""}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Laher', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Maganga', 'Affiliation': 'NIMR-Mbeya Medical Research Center, Mbeya, Tanzania.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Herce', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Naidoo', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'UNC Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Innes', 'Affiliation': 'Aurum Institute, Klerksdorp, South Africa.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Grunenberg', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Mann', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Allan C', 'Initials': 'AC', 'LastName': 'deCamp', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Maurine D', 'Initials': 'MD', 'LastName': 'Miner', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Yates', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Heptinstall', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Nonhlanhla N', 'Initials': 'NN', 'LastName': 'Mkhize', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'One', 'Initials': 'O', 'LastName': 'Dintwe', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Kristen W', 'Initials': 'KW', 'LastName': 'Cohen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland United States of America.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hutter', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland United States of America.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'Institute of Medical Microbiology and Hygiene, University of Regensberg, Regensberg, Germany.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Swiss Vaccine Research Institute, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Duke Human Vaccine Institute, Department of Surgery Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Andersen-Nissen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Glenda E', 'Initials': 'GE', 'LastName': 'Gray', 'Affiliation': 'South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003117']
3251,32442198,No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya.,"BACKGROUND


Attention has recently turned toward the use of device-assisted male circumcision to help scale up male circumcision services in sub-Saharan Africa, with increasing emphasis on younger age groups. We assessed the use of the ShangRing for circumcising the subset of boys aged 10 to 12 years who were enrolled in two randomized clinical trials in Kenya.
METHODS


We performed a sub-analysis of outcomes in 197 boys aged 10 to 12 years; a subset who were enrolled in two randomized clinical trials to assess the use of the no-flip ShangRing circumcision technique in men and boys. One trial assessed spontaneous detachment vs. planned removal of the ShangRing 7 days post-circumcision. The second trial compared the use of topical vs. injectable anesthesia with ShangRing circumcision. Aside from baseline characteristics, data was collected and analyzed for each trial separately.
RESULTS


All participants were successfully circumcised. Duration of circumcision, participants requiring a dorsal slit, rate of adverse events, time to complete wound healing, and participant satisfaction were similar between the two groups in each trial. Mean time required for spontaneous ShangRing detachment was 14.82±3.76 days. Topical anesthesia showed a significantly lower mean pain score at the time of application (0.64±1.71 vs. 1.55± 2.21, p = 0.03) as well as postoperatively (0.54±0.88 vs. 1.72±1.56, p<0.0001). Median dwell time of the topical anesthetic was 43 (IQR: 35.5-60) minutes, while the median time it took the injectable anesthetic to take effect was 2.04 (IQR: 1.72-3.09) minutes.
CONCLUSION


No-flip ShangRing circumcision had a positive safety profile among young adolescent boys, specifically ages 10-12 years. The use of spontaneous device detachment and topical anesthesia with the procedure have shown promising outcomes in this age group. This may have the potential to further increase the acceptability of ShangRing circumcision, and therefore accelerate the scle up of male circumcision services in sub-Saharan Africa.
TRIAL REGISTRATION


ClinicalTrials.gov registration # NCT02390310.",2020,"Topical anesthesia showed a significantly lower mean pain score at the time of application (0.64±1.71 vs. 1.55± 2.21, p = 0.03) as well as postoperatively (0.54±0.88 vs. 1.72±1.56, p<0.0001).","['boys aged 10 to 12 years who were enrolled in two randomized clinical trials in Kenya', 'young adolescent boys, specifically ages 10-12 years', '10-12 year old boys', '197 boys aged 10 to 12 years', 'in men and boys']","['topical vs. injectable anesthesia with ShangRing circumcision', 'no-flip ShangRing circumcision technique', 'Topical anesthesia']","['Duration of circumcision, participants requiring a dorsal slit, rate of adverse events, time to complete wound healing, and participant satisfaction', 'Median dwell time of the topical anesthetic', 'positive safety profile', 'mean pain score', 'Mean time required for spontaneous ShangRing detachment']","[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}]",197.0,0.304241,"Topical anesthesia showed a significantly lower mean pain score at the time of application (0.64±1.71 vs. 1.55± 2.21, p = 0.03) as well as postoperatively (0.54±0.88 vs. 1.72±1.56, p<0.0001).","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Al Hussein Alawamlh', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}, {'ForeName': 'Quentin D', 'Initials': 'QD', 'LastName': 'Awori', 'Affiliation': 'EngenderHealth, Nairobi, Kenya.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Barone', 'Affiliation': 'EngenderHealth, Washington, DC, NY, United States of America.'}, {'ForeName': 'Soo-Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Li', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, James Buchanan Brady Foundation, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell College of Cornell University, New York, NY, United States of America.'}]",PloS one,['10.1371/journal.pone.0233150']
3252,32442205,No effect of repetitive tDCS on daily smoking behaviour in light smokers: A placebo controlled EMA study.,"INTRODUCTION


The effectiveness of repetitive transcranial Direct Current Stimulation (tDCS) on reducing smoking behaviour has been studied with mixed results. Smoking behaviour is influenced by affect and context, therefore we choose to use mobile ecological momentary assessments (EMA) to measure changes in smoking behaviour after tDCS.
METHODS


In a randomized, placebo-controlled, between subject study, we applied tDCS bilaterally with the anodal electrode targeting the right DLPFC (https://clinicaltrials.gov/ct2/show/NCT03027687). Smokers were allocated to six sessions of either active tDCS (n = 35) or sham tDCS (n = 36) and received two sessions on three different days in one week. They were asked to keep track of their daily cigarette consumption, craving and affect in an application on their mobile phones for three months starting one week before the first tDCS session.
RESULTS


Number of smoked cigarettes a day progressively decreased up to one week after the last tDCS session in both conditions. Active treatment had no additional effect on cigarette consumption, craving and affect.
CONCLUSIONS


In this exploratory study, repetitive bilateral tDCS over the DLPFC had no effect on daily smoking behaviour. Future research needs to investigate how motivation to quit smoking and the number of tDCS sessions affect the efficacy of repetitive tDCS.",2020,"Active treatment had no additional effect on cigarette consumption, craving and affect.
",['light smokers'],"['repetitive transcranial Direct Current Stimulation (tDCS', 'sham tDCS', 'active tDCS', 'repetitive tDCS', 'placebo']","['daily smoking behaviour', 'cigarette consumption, craving and affect']","[{'cui': 'C3494624', 'cui_str': 'Light tobacco smoker'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",36.0,0.0277547,"Active treatment had no additional effect on cigarette consumption, craving and affect.
","[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verveer', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Remmerswaal', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Joran', 'Initials': 'J', 'LastName': 'Jongerling', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'van der Veen', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Ingmar H A', 'Initials': 'IHA', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0233414']
3253,32442298,"Dose-adjusted enoxaparin thromboprophylaxis in hospitalized cancer patients: a randomized, double-blinded multicenter phase 2 trial.","Hospitalized patients with cancer are at an increased risk of developing venous thromboembolism (VTE). The recommendation for routine pharmacologic thromboprophylaxis in hospitalized patients with cancer to prevent VTE is based on extrapolation of results from noncancer cohorts. There are limited data to support the efficacy and safety of fixed-dose low-molecular-weight heparin (LMWH) regimens in high-risk hospitalized patients with cancer. We conducted a randomized, double-blinded, phase 2 trial in hospitalized patients with active cancer at high risk of developing VTE based on Padua risk score. Patients were randomly assigned to fixed-dose enoxaparin (40 mg daily) vs weight-adjusted enoxaparin (1 mg/kg daily) during hospitalization. The primary objectives were to evaluate the safety of dose-adjusted enoxaparin and evaluate the incidence of VTE with fixed-dose enoxaparin. Blinded clinical assessments were performed at day 14, and patients randomly assigned to fixed-dose enoxaparin subsequently underwent a bilateral lower extremity ultrasound. A total of 50 patients were enrolled and randomized. The median weight of patients enrolled in weight-adjusted enoxaparin arm was 76 kg (range, 60.9-124.5 kg). There were no major hemorrhages or symptomatic VTE in either arm. At time of completion of the blinded clinical assessment, there was only 1 incidentally identified pulmonary embolus that occurred in the weight-adjusted arm. In the group randomly assigned to fixed-dose enoxaparin who subsequently underwent surveillance ultrasound, the cumulative incidence of DVT was 22% (90% binomial confidence interval, 0%-51.3%). This phase 2 trial confirms a high incidence of asymptomatic VTE among high-risk hospitalized patients with cancer and that weight-adjusted LMWH thromboprophylaxis is feasible and well-tolerated. This trial was registered at www.clinicaltrials.gov as #NCT02706249.",2020,There were no major hemorrhages or symptomatic VTE in either arm.,"['high-risk hospitalized patients with cancer and that weight-adjusted', 'Hospitalized patients with cancer', 'hospitalized patients with active cancer at high risk of developing VTE based on Padua risk score', 'hospitalized cancer patients', 'A total of 50 patients were enrolled and randomized', 'hospitalized patients with cancer', 'high-risk hospitalized patients with cancer']","['LMWH thromboprophylaxis', 'enoxaparin thromboprophylaxis', 'enoxaparin', 'weight-adjusted enoxaparin', 'heparin (LMWH) regimens']","['cumulative incidence of DVT', 'major hemorrhages or symptomatic VTE', 'median weight', 'risk of developing venous thromboembolism (VTE']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",50.0,0.551685,There were no major hemorrhages or symptomatic VTE in either arm.,"[{'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Zwicker', 'Affiliation': 'Division of Hematology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Roopkumar', 'Affiliation': 'Division of Hematology and Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Maneka', 'Initials': 'M', 'LastName': 'Puligandla', 'Affiliation': 'Department of Data Sciences, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Schlechter', 'Affiliation': 'Gastrointestinal Cancer Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; and.'}, {'ForeName': 'Anish V', 'Initials': 'AV', 'LastName': 'Sharda', 'Affiliation': 'Division of Hematology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peereboom', 'Affiliation': 'Division of Hematology and Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Joyce', 'Affiliation': 'Division of Hematology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bockorny', 'Affiliation': 'Division of Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Neuberg', 'Affiliation': 'Department of Data Sciences, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Bauer', 'Affiliation': 'Division of Hematology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Alok A', 'Initials': 'AA', 'LastName': 'Khorana', 'Affiliation': 'Division of Hematology and Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH.'}]",Blood advances,['10.1182/bloodadvances.2020001804']
3254,32443008,"Effects of a Single Dose of Topical Brimonidine 0.15% on Anterior Segment Morphology, Pupil Characteristics, and Choroidal Thickness in Healthy Subjects.","PURPOSE


To investigate the effects of a single dose of brimonidine 0.15% on anterior segment morphology, pupil characteristics, and choroidal blood flow in treated and untreated eyes of healthy subjects and to compare the results obtained with those in another healthy volunteer group.
METHODS


Participants were classified as study and control groups. The eyes in the study group were randomized. Only one eye received one drop of brimonidine (treated eyes), and the contralateral eye received single dose of sodium hyaluronate (untreated eyes). In addition, only right eyes of control subjects, who had single dose of sodium hyaluronate to both eyes, were analyzed (control eyes). Anterior segment parameters including central corneal thickness (CCT), aqueous depth, anterior chamber volume, iridocorneal angle (ICA), horizontal anterior chamber diameter, and pupil measurements including scotopic, mesopic, photopic, and dynamic pupil diameters (PDs) were performed with Sirius Scheimpflug camera. Choroidal thickness (CT) measurements were taken with optical coherence tomography. These measurements were taken at baseline and repeated 1 hour after the dosing.
RESULTS


Only the treated eyes had significantly thicker CCT and wider ICA values after instillation of brimonidine. Static and dynamic PD values of treated eyes and even untreated eyes significantly decreased after brimonidine. However, brimonidine has no significant effect on CT measurements.
CONCLUSION


A single dose of brimonidine causes thickening in CCT and widening in ICA values in treated eyes. In addition, it has significant effect to decrease the scotopic, mesopic, photopic, and dynamic PD values in treated and even contralateral eyes while has no effect on choroidal blood flow.",2020,Static and dynamic PD values of treated eyes and even untreated eyes significantly decreased after brimonidine.,"['another healthy volunteer group', 'Participants were classified as study and control groups', 'treated and untreated eyes of healthy subjects', 'Healthy Subjects']","['Topical Brimonidine', 'brimonidine', 'sodium hyaluronate']","['Choroidal thickness (CT) measurements', 'CT measurements', 'scotopic, mesopic, photopic, and dynamic PD values', 'central corneal thickness (CCT), aqueous depth, anterior chamber volume, iridocorneal angle (ICA), horizontal anterior chamber diameter, and pupil measurements including scotopic, mesopic, photopic, and dynamic pupil diameters (PDs', 'anterior segment morphology, pupil characteristics, and choroidal blood flow', 'Static and dynamic PD values', 'thicker CCT and wider ICA values', 'Anterior Segment Morphology, Pupil Characteristics, and Choroidal Thickness', 'choroidal blood flow']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0229238', 'cui_str': 'Structure of iridocorneal angle'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0332464', 'cui_str': 'Widening'}]",,0.0170149,Static and dynamic PD values of treated eyes and even untreated eyes significantly decreased after brimonidine.,"[{'ForeName': 'Veysel', 'Initials': 'V', 'LastName': 'Cankurtaran', 'Affiliation': 'Ophthalmology Department (V.C.), Mustafa Kemal University, Hatay, Turkey; and Ophthalmology Department (K.T.), Ercis State Hospital, Van, Turkey.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Tekin', 'Affiliation': ''}]",Eye & contact lens,['10.1097/ICL.0000000000000708']
3255,32443036,Effectivity of Pancreatic Enzyme Replacement Therapy in Malnourished Children.,"OBJECTIVE


Malnutrition is commonly seen in children with exocrine pancreatic insufficiency (EPI). Pancreatic enzyme replacement therapy (PERT) is the mainstay treatment of acute malnutrition in children detected with a disease closely associated with EPI (eg, cystic fibrosis). The effectiveness of PERT in children with malnutrition without any chronic disease, however, remains unclear. The aim of this study was to investigate the effectiveness of PERT on weight gain and EPI in children classified as moderately and severely malnourished according to the World Health Organization (WHO) classification.
MATERIALS AND METHODS


The study included a total of 40 children aged 2-16 years who were classified as moderately and severely malnourished according to the WHO classification. The patients were randomly divided into 2 groups: PERT group (n = 20) received 2000 U lipase/kg/day (in 4 doses) in addition to hypercaloric enteral supplements and control group received hypercaloric enteral supplements only. In both groups, anthropometric measurements and the assessment of fecal elastase-1 (FE-1) levels were performed both at first admission and at the end of the 8-week treatment period.
RESULTS


On the basis of WHO classification, 10 (25%) children were classified as severely malnourished and 30 (75%) children as moderately malnourished. EPI was detected in all the patients, among whom 24 (60%) patients had severe EPI. At the end of the treatment, body weight, height, and body mass index (BMI) increased significantly in both groups compared to their pre-treatment values, whereas no significant difference was found with regard to waist circumference (WC) and FE-1 levels. Similarly, no significant difference was found between pre- and posttreatment measurements of PERT and control groups (P > 0.05) and between pre- and posttreatment measurements of patients with moderate and severe malnutrition (P > 0.05).
CONCLUSIONS


Malnutrition remains a serious public health problem, and thus, the development of novel treatment methods is highly essential. PERT is one of the most commonly considered alternatives, although there is little documentation of PERT in the literature. In the present study, although PERT resulted in higher weight gain, it established no significant difference between the 2 groups.",2020,"At the end of the treatment, body weight, height, and body mass index (BMI) increased significantly in both groups compared to their pre-treatment values, whereas no significant difference was found with regard to waist circumference (WC) and FE-1 levels.","['children classified as moderately and severely malnourished according to the World Health Organization (WHO) classification', 'children with exocrine pancreatic insufficiency (EPI', '40 children aged 2-16 years who were classified as moderately and severely malnourished according to the WHO classification', 'acute malnutrition in children detected with a disease closely associated with EPI (eg, cystic fibrosis', 'Malnourished Children', 'children with malnutrition without any chronic disease']","['2000\u200aU lipase/kg/day (in 4 doses) in addition to hypercaloric enteral supplements and control group received hypercaloric enteral supplements only', 'Pancreatic Enzyme Replacement Therapy', 'Pancreatic enzyme replacement therapy (PERT', 'PERT']","['body weight, height, and body mass index (BMI', 'fecal elastase-1 (FE-1) levels', 'weight gain', 'severe malnutrition', 'severe EPI', 'weight gain and EPI', 'waist circumference (WC) and FE-1 levels', 'EPI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0267963', 'cui_str': 'Exocrine pancreatic insufficiency'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1257753', 'cui_str': 'Malnutrition in Children'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0439418', 'cui_str': 'kg/day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4523842', 'cui_str': 'Pancreatic enzyme replacement therapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0030306', 'cui_str': 'Pancreatic elastase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0267963', 'cui_str': 'Exocrine pancreatic insufficiency'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1272315', 'cui_str': 'Fecal elastase 1 level'}]",40.0,0.0311251,"At the end of the treatment, body weight, height, and body mass index (BMI) increased significantly in both groups compared to their pre-treatment values, whereas no significant difference was found with regard to waist circumference (WC) and FE-1 levels.","[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Güven', 'Affiliation': 'Department of Pediatric Gastroenterology, Karadeniz Technical University Faculty of Medicine, Trabzon.'}, {'ForeName': 'Mevsim', 'Initials': 'M', 'LastName': 'Demir Mis', 'Affiliation': 'Department of Pediatrics, Van Yuzuncu Yil University Faculty of Medicine, Van.'}, {'ForeName': 'Kamuran', 'Initials': 'K', 'LastName': 'Karaman', 'Affiliation': 'Department of Pediatric Heamatology, Van Yuzuncu Yil University Faculty of Medicine, Van, Turkey.'}, {'ForeName': 'Akkiz', 'Initials': 'A', 'LastName': 'Şahin Yaşar', 'Affiliation': 'Department of Pediatric Heamatology, Van Yuzuncu Yil University Faculty of Medicine, Van, Turkey.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002689']
3256,32443067,Opioid Analgesia for Medical Abortion: A Randomized Controlled Trial.,,2020,,['Medical Abortion'],['Opioid Analgesia'],[],"[{'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",[],,0.170735,,"[{'ForeName': 'Zoe M', 'Initials': 'ZM', 'LastName': 'Feld', 'Affiliation': 'University of California, Davis, Davis, California A.T. Still University School of Osteopathic Medicine in Arizona, Mesa, Arizona University of California, Davis, Davis, California.'}, {'ForeName': 'Kimia', 'Initials': 'K', 'LastName': 'Etemadi', 'Affiliation': ''}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003904']
3257,32443068,Opioid Analgesia for Medical Abortion: A Randomized Controlled Trial.,,2020,,['Medical Abortion'],['Opioid Analgesia'],[],"[{'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",[],,0.170735,,"[{'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Clure', 'Affiliation': 'Division of Family Planning, Department of Obstetrics & Gynecology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Guiahi', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003905']
3258,32443142,The Long-term Effectiveness of the Automatic Position-Adaptive System in Spinal Cord Stimulation: A Retrospective Comparative Study with a Two-Year Follow-up.,"OBJECTIVE


To compare the nonadaptive manual system with the position-adaptive system in subjects with permanent spinal cord stimulator (SCS) implantation over a two-year follow-up period.
DESIGN


Retrospective study.
SETTING


Tertiary university-based national hospital.
SUBJECTS


Patients who underwent permanent SCS implantation procedures.
METHODS


Patients were divided into an adaptive group and a nonadaptive group according to the type of implanted SCS device. The primary outcome was the change (%) in pain intensity from baseline between the adaptive and nonadaptive groups at 24 months after SCS implantation. The secondary outcomes were comparisons of detailed clinical variables such as the scores of patient pain and satisfaction during the two-year follow-up after SCS therapy. Further, the number of subjects with SCS removal or revision within two years after SCS implantation was investigated.
RESULTS


Of 187 patients with permanent SCS implantation, 85 in the nonadaptive group and 64 in the position-adaptive group were finally analyzed. The reduction in pain intensity at 24 months was higher in the adaptive group (-38.6%) than in the nonadaptive group (-30.8%, P = 0.05). Similarly, patient satisfaction with the SCS treatment at 24 months was superior in the adaptive group than in the nonadaptive group (85.7% vs 67.5% were satisfied in each group, respectively, P = 0.024). During the two years, 5.3% of patients (N = 10) underwent SCS removal and 7.0% (N = 13) underwent revision procedures.
CONCLUSIONS


There was a trend of a sustained reduction in pain intensity as well as improvement in patient satisfaction at two-year follow-up in the position-adaptive system, suggesting long-term benefit over the nonadaptive manual system during SCS treatment.",2020,"There was a trend of a sustained reduction in pain intensity as well as improvement in patient satisfaction at two-year follow-up in the position-adaptive system, suggesting long-term benefit over the nonadaptive manual system during SCS treatment.","['Tertiary university-based national hospital', 'Patients', '187 patients with permanent SCS implantation, 85 in the nonadaptive group and 64 in the position-adaptive group were finally analyzed', 'subjects with permanent spinal cord stimulator (SCS) implantation over a two-year follow-up period', 'Patients who underwent permanent SCS implantation procedures', 'Spinal Cord Stimulation']","['Automatic Position-Adaptive System', 'nonadaptive group according to the type of implanted SCS device']","['change (%) in pain intensity', 'pain intensity', 'patient satisfaction', 'scores of patient pain and satisfaction']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449497', 'cui_str': 'Type of device'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",187.0,0.0470401,"There was a trend of a sustained reduction in pain intensity as well as improvement in patient satisfaction at two-year follow-up in the position-adaptive system, suggesting long-term benefit over the nonadaptive manual system during SCS treatment.","[{'ForeName': 'Eun Kyoung', 'Initials': 'EK', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chang-Soon', 'Initials': 'CS', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yongjae', 'Initials': 'Y', 'LastName': 'Yoo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Jung Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Youngwon', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jee Youn', 'Initials': 'JY', 'LastName': 'Moon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yong-Chul', 'Initials': 'YC', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa121']
3259,32443179,A polling experiment on public opinion on the future expansion of Medicare and Medicaid.,"OBJECTIVE


To conduct a polling experiment to understand the possible framing effects that drive constituents' views around Medicare For All (MFA) and Medicaid Buy-In (MBI).
DATA SOURCES AND STUDY SETTING


Five thousand and fifty-one US adults aged 18 and older were recruited to participate in an online poll conducted between September 12, 2018, and September 26, 2018.
STUDY DESIGN


Participants were randomized to receive one of four polls: (a) a poll measuring respondent approval for MFA, with the name of the proposal stated with a description; (b) a poll measuring approval for MFA, with only a description of the proposal; (c) a poll measuring approval for MBI, with the name stated with a description; or (d) a poll measuring approval for MBI, with only a description.
PRINCIPAL FINDINGS


Including the names ""Medicare For All"" and ""Medicaid Buy-In"" increases approval by 3.4 (from 32.7 percent to 36.1 percent) and 5.0 (from 50.1 percent to 55.1 percent) percentage points, respectively. Support varies by age, where MBI is most strongly supported by Millennials, while Baby Boomers and those older than 65 are more likely to support MFA.
CONCLUSIONS


Constituents are more likely to support a proposal when given the names of the proposal. Approval is also higher for health policies that are framed as expansions of existing policies than as new programs.",2020,"Support varies by age, where MBI is most strongly supported by Millennials, while Baby Boomers and those older than 65 are more likely to support MFA.
","['Participants', 'Five thousand and fifty-one US adults aged 18 and older were recruited to participate in an online poll conducted between September 12, 2018, and September 26, 2018']","['poll measuring respondent approval for MFA, with the name of the proposal stated with a description; (b) a poll measuring approval for MFA, with only a description of the proposal; (c) a poll measuring approval for MBI, with the name stated with a description; or (d) a poll measuring approval for MBI, with only a description']",[],"[{'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}]",[],5051.0,0.0357672,"Support varies by age, where MBI is most strongly supported by Millennials, while Baby Boomers and those older than 65 are more likely to support MFA.
","[{'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Karra', 'Affiliation': 'Frederick S. Pardee School of Global Studies, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sandoe', 'Affiliation': 'Graduate School of Arts and Sciences, Harvard University, Cambridge, Massachusetts, USA.'}]",Health services research,['10.1111/1475-6773.13295']
3260,32443357,"A prospective observational study to explore the correlation of peripheral arterial pulse/resistance index, organ function, and inflammation in patients with septic shock.","INTRODUCTION


The evaluation of the functional status of blood vessels, especially the arterial system, plays a very important role in the judgment of the condition of septic shock patients and the guidance of resuscitation programs and the judgment of the therapeutic effect. We aimed to design an observational study protocol to explore the correlation of peripheral arterial pulse/resistance index, organ function and inflammation in patients with septic shock.
METHODS AND ANALYSIS


A total of 60 patients with septic shock in the Affiliated Hospital of Southwest Medical University from June 2020 to September 2020 and 20 healthy volunteers will be enrolled. Total of 60 patients with septic shock will be randomly divided into 20 groups by lot method. Group 1: fluid resuscitation; Group 2: fluid resuscitation + norepinephrine; Group 3: fluid resuscitation + norepinephrine + ulinastatin; Group 4: healthy control group. Fluid resuscitation is an early goal-directed fluid resuscitation in which norepinephrine is adjusted by a senior intensive care unit specialist for clinical presentation and ulinastatin is pumped at 20,000 U/h. Index including vascular ultrasound, inflammatory factors, organ function will be collected and analyzed.
DISCUSSION


Existing studies on septic shock focus on hemodynamics of the heart, brain, and kidney, while the differences in blood flow between peripheral blood vessels and protective renal vessels may be consistent, and imaging analysis is still lacking. This study protocol aims to explore the correlation of peripheral arterial pulsation index/resistance index, organ function, and inflammation in patients with septic shock.
TRIAL REGISTRATION


Chinese Clinical trial registry: ChiCTR2000031565.",2020,"The evaluation of the functional status of blood vessels, especially the arterial system, plays a very important role in the judgment of the condition of septic shock patients and the guidance of resuscitation programs and the judgment of the therapeutic effect.","['patients with septic shock', '60 patients with septic shock', '60 patients with septic shock in the Affiliated Hospital of Southwest Medical University from June 2020 to September 2020 and 20 healthy volunteers will be enrolled']","['Fluid resuscitation', 'fluid resuscitation; Group 2: fluid resuscitation\u200a+\u200anorepinephrine; Group 3: fluid resuscitation\u200a+\u200anorepinephrine\u200a+\u200aulinastatin; Group 4: healthy control group']","['peripheral arterial pulse/resistance index, organ function and inflammation', 'peripheral arterial pulse/resistance index, organ function, and inflammation', 'peripheral arterial pulsation index/resistance index, organ function, and inflammation', 'Index including vascular ultrasound, inflammatory factors, organ function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0077906', 'cui_str': 'urinastatin'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0948543', 'cui_str': 'Vascular ultrasound'}]",60.0,0.138439,"The evaluation of the functional status of blood vessels, especially the arterial system, plays a very important role in the judgment of the condition of septic shock patients and the guidance of resuscitation programs and the judgment of the therapeutic effect.","[{'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'ICU, Affiliated Hospital of Southwest Medical University.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Leng', 'Affiliation': 'Department of General Surgery, Affiliated Hospital of Traditional Chinese Medicine, Southwest Medical University.'}, {'ForeName': 'Changxue', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'ICU, Affiliated Hospital of Southwest Medical University.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Critical Care, Luzhou Maternal and Child Health Hospital, Luzhou, Sichuan, China.'}]",Medicine,['10.1097/MD.0000000000020235']
3261,32443364,Home-based rehabilitation using smart wearable knee exercise device with electrical stimulation after anterior cruciate ligament reconstruction: A study protocol for a randomized controlled trial.,"INTRODUCTION


Rehabilitation after anterior cruciate ligament (ACL) reconstruction is critical to patient outcome. Despite its importance; however, hospital-based rehabilitation is limited, with barriers, including distance and cost. With recent technological advancements, wearable devices have actively been used to address these barriers. In this study, we propose a randomized controlled trial protocol investigating the efficacy and feasibility of home-based rehabilitation after ACL reconstruction using a smart wearable device providing electrical stimulation that allows knee exercise.
METHODS AND ANALYSIS


This is a protocol proposal for a prospective, single-center, randomized, controlled study. We plan to recruit adults discharged after ACL reconstruction; the recruited subjects will be randomly allocated to 1 of 2 groups, using a computer-generated randomization method: the intervention (n = 20) or control group (n = 20). The intervention group will receive a 6-week home-based rehabilitation program using smart wearable device. The control group will undergo a 6-week self-exercise program as normal. The following outcomes will be assessed at baseline, 2 weeks, and 6 weeks post the 6-week intervention program: quadriceps strength of the affect side as measured by a dynamometer (primary outcome); range of motion; root mean square of quadriceps muscle using surface electromyography; knee function using questionnaire; quality of life; subject's satisfaction score using questionnaire; frequency and duration of exercise; and knee pain. An intention-to-treat analysis will be conducted for the primary outcome.
DISCUSSION


This study is a prospective, single-center, randomized, controlled study. This study aims to research the feasibility and efficacy of a 6-week, structured home-based rehabilitation program for patients after ACL reconstruction using a smart wearable device. The findings of this study will help to establish a home-based rehabilitation program to better recovery in patients with ACL reconstruction.
TRIAL REGISTRATION NUMBER


This protocol was registered in ClinicalTrials.gov, under the number NCT04079205.",2020,"This study aims to research the feasibility and efficacy of a 6-week, structured home-based rehabilitation program for patients after ACL reconstruction using a smart wearable device.","['patients after ACL reconstruction using a smart wearable device', 'adults discharged after ACL reconstruction; the recruited subjects', 'anterior cruciate ligament reconstruction', 'patients with ACL reconstruction']","['home-based rehabilitation after ACL reconstruction', '6-week self-exercise program', '6-week home-based rehabilitation program using smart wearable device', 'Rehabilitation after anterior cruciate ligament (ACL) reconstruction', 'Home-based rehabilitation using smart wearable knee exercise device with electrical stimulation', 'structured home-based rehabilitation program']","[""quadriceps strength of the affect side as measured by a dynamometer (primary outcome); range of motion; root mean square of quadriceps muscle using surface electromyography; knee function using questionnaire; quality of life; subject's satisfaction score using questionnaire; frequency and duration of exercise; and knee pain""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0454364', 'cui_str': 'Knee exercises'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}]",,0.103089,"This study aims to research the feasibility and efficacy of a 6-week, structured home-based rehabilitation program for patients after ACL reconstruction using a smart wearable device.","[{'ForeName': 'Gowun', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si.'}, {'ForeName': 'Won-Seok', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si.'}, {'ForeName': 'Tae Woo', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul.'}, {'ForeName': 'Yong Seuk', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'EXOSYSTEMS Inc., Seongnam-si, Republic of Korea.'}, {'ForeName': 'Nam-Jong', 'Initials': 'NJ', 'LastName': 'Paik', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si.'}]",Medicine,['10.1097/MD.0000000000020256']
3262,32443379,An investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ECASIS).,"INTRODUCTION


Uncertainty remains regarding the impact of enteric-coated (EC) aspirin as it relates to the reduction of cardiovascular risk. We hypothesize that EC formulation based on a previous report may blunt aspirin response as evidenced by reduced Thromboxane A2 (TXA 2) levels in diabetic patients. Thus, it was imperative to ascertain and validate the effect of the EC formulation of Aspirin on the Thromboxane B2 (TXB2) level.
METHODS/DESIGN


An open-label consecutive randomized interventional controlled trial. Patients with newly diagnosed ischemic stroke who are just about to start Aspirin were assessed for eligibility and inclusion in our trial. Consecutive patients (admitted to the stroke unit of Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar) will be randomized to receive either EC aspirin or plain Aspirin. They will be required to continue taking them throughout the study (3 days). Demographics and laboratory records of the study participants will be abstracted from online records. Further study variables will be obtained manually in designated case record forms (CRF). The primary outcomes are the incidence of aspirin non-responders (level of residual serum TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/mL) within 72 h after three daily aspirin doses). Whereas secondary outcomes are the incidence of GIT bleeding of various preparations of Aspirin. The study was approved by MRC and IRB of Hamad Medical Corporation (MRC number: 01-18-156).
DISCUSSION


This trial will determine potential differences in the efficacy of EC Aspirin and plain Aspirin on the Thromboxane B2 level. Additionally, it will ascertain the tolerability and safety of both formulations of Aspirin in patients with newly diagnosed ischemic stroke. These results will either support the current notion of no difference between the two formulations. However, if a difference is found, this will invite for future trials exploring clinical outcomes occurrence between various formulations.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov NCT04330872 registered on April 2, 2020.",2020,TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/mL) within 72 h after three daily aspirin doses).,"['patients with newly diagnosed ischemic stroke (ECASIS', 'Patients with newly diagnosed ischemic stroke who are just about to start', 'Consecutive patients (admitted to the stroke unit of Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar', 'diabetic patients', 'patients with newly diagnosed ischemic stroke']","['enteric-coated (EC) aspirin', 'TXB2', 'Aspirin', 'aspirin', 'EC aspirin or plain Aspirin', 'EC Aspirin and plain Aspirin']","['Thromboxane A2 (TXA 2) levels', 'Thromboxane B2 (TXB2) level', 'incidence of aspirin non-responders (level of residual serum', 'elevated thrombotic risk', 'incidence of GIT bleeding of various preparations of Aspirin', 'Thromboxane B2 level', 'tolerability and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0034366', 'cui_str': 'Qatar'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0040059', 'cui_str': 'Thromboxane B>2<'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0040057', 'cui_str': 'Thromboxane A>2<'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040059', 'cui_str': 'Thromboxane B>2<'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.103097,TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/mL) within 72 h after three daily aspirin doses).,"[{'ForeName': 'Mohamed Nabil', 'Initials': 'MN', 'LastName': 'Elshafei', 'Affiliation': 'Clinical Pharmacy Department.'}, {'ForeName': 'Yahia', 'Initials': 'Y', 'LastName': 'Imam', 'Affiliation': 'Neurology Department, Hamad General Hospital, Hamad Medical Corporation.'}, {'ForeName': 'Mouhand F H', 'Initials': 'MFH', 'LastName': 'Mohamed', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Arwa Ebrahim', 'Initials': 'AE', 'LastName': 'AlSaud', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Mohamed Sayed', 'Initials': 'MS', 'LastName': 'Ahmed', 'Affiliation': 'Neurology Department, Hamad General Hospital, Hamad Medical Corporation.'}, {'ForeName': 'Khaldun', 'Initials': 'K', 'LastName': 'Obeidat', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Razan', 'Initials': 'R', 'LastName': 'Saeid', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}, {'ForeName': 'Ibtihal M', 'Initials': 'IM', 'LastName': 'Abdallah', 'Affiliation': 'Clinical Pharmacy Department.'}, {'ForeName': 'Aeijaz Sultan', 'Initials': 'AS', 'LastName': 'Parray', 'Affiliation': 'Interim-Lab, Hamad Medical City, Hamad Medical Corporation.'}, {'ForeName': 'Mohammed Ibn-Masoud', 'Initials': 'MI', 'LastName': 'Danjuma', 'Affiliation': 'Internal Medicine Department, Hamad General Hospital.'}]",Medicine,['10.1097/MD.0000000000020307']
3263,32443390,Effects of virtual reality immersive training with computerized cognitive training on cognitive function and activities of daily living performance in patients with acute stage stroke: A preliminary randomized controlled trial: Retraction.,,2020,,['patients with acute stage stroke'],['virtual reality immersive training with computerized cognitive training'],['cognitive function and activities of daily living performance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.160731,,[],Medicine,['10.1097/MD.0000000000020598']
3264,32445271,Rapid enzymatic burn debridement: A review of the paediatric clinical trial experience.,"NexoBrid (NXB) has been proven to be an effective selective enzymatic debridement agent in adults. This manuscript presents the combined clinical trial experience with NXB in children. Hundred and ten children aged 0.5 to 18 years suffering from deep thermal burns of up to 67% total body surface area were treated with NXB in three clinical trials. Seventy-seven children were treated with NXB in a phase I/II study, where 92.7% of the areas treated achieved complete eschar removal within 0.9 days from admission. Thirty-three children (17 NXB, 16 standard of care [SOC]) participated in a phase III randomized controlled trial. All wounds treated with NXB achieved complete eschar removal. Time to complete eschar removal (from informed consent) was 0.9 days for NXB vs 6.5 days for SOC (P < .001). The incidence of surgical excision was 7.9% for NXB vs 73.3% for SOC (P < .001). Seventeen of these children participated in a phase III-b follow-up study (9 NXB and 8 SOC). The average long-term modified Vancouver Scar Scale scores were 3.4 for NXB-treated wounds vs 4.4 for SOC-treated wounds (NS). There were no significant treatment-related adverse events. Additional studies are needed to strengthen these results.",2020,The incidence of surgical excision was 7.9% for NXB vs 73.3% for SOC (P < .001).,"['Seventy-seven children', 'Hundred and ten children aged 0.5 to 18\u2009years suffering from deep thermal burns of up to 67% total body surface area were treated with', 'Thirty-three children (17 NXB, 16 standard of care [SOC', 'children']","['Rapid enzymatic burn debridement', 'NXB', 'NexoBrid (NXB']","['complete eschar removal', 'adverse events', 'average long-term modified Vancouver Scar Scale scores', 'incidence of surgical excision', 'Time to complete eschar removal']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0701836', 'cui_str': 'Thermal burn'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0841424', 'cui_str': 'Burn debridement'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0521172', 'cui_str': 'Eschar'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0728940', 'cui_str': 'Excision'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",77.0,0.0225596,The incidence of surgical excision was 7.9% for NXB vs 73.3% for SOC (P < .001).,"[{'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Shoham', 'Affiliation': 'Plastic Surgery Department and Burn Unit, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheba, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Krieger', 'Affiliation': 'Plastic Surgery Department and Burn Unit, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheba, Israel.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Rubin', 'Affiliation': 'Orthopaedic Department, Central Emek Hospital, Afula, Israel.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Koenigs', 'Affiliation': 'Department of Pediatric Surgery, Pediatric Burn Unit, Plastic and Reconstructive Surgery in Children, Altonaer Kinderkrankenhaus & University Medical Center , Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Burn Center with Plastic Surgery, Unfallkrankenhaus Berlin, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Sander', 'Affiliation': 'Burn Center with Plastic Surgery, Unfallkrankenhaus Berlin, Berlin, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Schulz', 'Affiliation': 'Department of Plastic Surgery, Hand Surgery, Burn Center, University of Witten/Herdecke, Cologne-Merheim Medical Center (CMMC), Cologne, Germany.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'David', 'Affiliation': 'MediWound Ltd., Yavne, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Rosenberg', 'Affiliation': 'MediWound Ltd., Yavne, Israel.'}, {'ForeName': 'Eldad', 'Initials': 'E', 'LastName': 'Silberstein', 'Affiliation': 'Plastic Surgery Department and Burn Unit, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheba, Israel.'}]",International wound journal,['10.1111/iwj.13405']
3265,32445277,Exhalation delivery system with fluticasone improves quality of life and health status: pooled analysis of phase 3 trials NAVIGATE I and II.,"BACKGROUND


Chronic rhinosinusitis with or without nasal polyps (CRSwNP/CRSsNP) seriously impairs health-related quality of life (HRQoL). This analysis describes the impact of the exhalation delivery system with fluticasone (EDS-FLU) on HRQoL, assessed by the 36-item Short-Form Health Survey version 2 (SF-36v2), and on utilities, assessed via the Short-Form 6-Dimension (SF-6D), in patients with CRSwNP.
METHODS


Post hoc analysis of pooled randomized clinical trial data (NAVIGATE I and II; N = 643) to examine change from baseline in SF-36v2 and SF-6D at end-of-double-blind (EODB: 16 weeks) and end-of-open-label (EOOL: 24 weeks; following 8 weeks of open-label treatment) for EDS-FLU vs placebo (EDS-PBO). Baseline characteristics predictive of change in SF-36 and SF-6D scores were assessed.
RESULTS


Mean baseline SF-36v2 scores were below population norms. At EODB, mean improvement was greater for all SF-36v2 domain and component scores with EDS-FLU (range: 2.9 [physical functioning] to 5.11 [bodily pain {BP}]) vs EDS-PBO (range: 0.81 [mental health] to 2.87 [BP]) (each comparison p < 0.01); physical and mental component score improvements within the EDS-FLU group exceeded the minimal clinically important difference (MCID). Clinically meaningful and statistically significant improvements in SF-6D utility scores were seen in EDS-FLU-treated patients compared to EDS-PBO-treated patients (0.058 vs 0.023, respectively, p < 0.001). At EOOL, SF-36v2 and SF-6D mean scores were at or above population norms, with clinically meaningful and statistically significant improvements from baseline.
CONCLUSION


In this pooled analysis of 2 large pivotal EDS-FLU trials, health domain and health utilities improvements were significantly greater with EDS-FLU than EDS-PBO and were comparable to population norms.",2020,"Clinically meaningful and statistically significant improvements in SF-6D utility scores were seen in EDS-FLU-treated patients compared to EDS-PBO-treated patients (0.058 vs 0.023, respectively, p < 0.001).",['patients with CRSwNP'],"['nasal polyps (CRSwNP/CRSsNP', 'EDS-FLU vs placebo (EDS-PBO', 'fluticasone (EDS-FLU', 'fluticasone']","['SF-6D utility scores', 'quality of life and health status', 'At EOOL, SF-36v2 and SF-6D mean scores', 'SF-36 and SF-6D scores', 'Mean baseline SF-36v2 scores', 'physical and mental component score improvements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.118395,"Clinically meaningful and statistically significant improvements in SF-6D utility scores were seen in EDS-FLU-treated patients compared to EDS-PBO-treated patients (0.058 vs 0.023, respectively, p < 0.001).","[{'ForeName': 'Zachary M', 'Initials': 'ZM', 'LastName': 'Soler', 'Affiliation': 'Division of Rhinology and Sinus Surgery, Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Colman', 'Affiliation': 'OptiNose US, Inc., Yardley, PA.'}, {'ForeName': 'Fulton F', 'Initials': 'FF', 'LastName': 'Velez', 'Affiliation': 'Covance Market Access Services Inc, Gaithersburg, MD.'}, {'ForeName': 'Rodney J', 'Initials': 'RJ', 'LastName': 'Schlosser', 'Affiliation': 'Division of Rhinology and Sinus Surgery, Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, SC.'}]",International forum of allergy & rhinology,['10.1002/alr.22573']
3266,32445295,The effectiveness of an interactive audio-tactile map for the process of cognitive mapping and recall among people with visual impairments.,"BACKGROUND


People with visual impairments can experience numerous challenges navigating unfamiliar environments. Systems that operate as prenavigation tools can assist such individuals. This mixed-methods study examined the effectiveness of an interactive audio-tactile map tool on the process of cognitive mapping and recall, among people who were blind or had visual impairments. The tool was developed with the involvement of visually impaired individuals who additionally provided further feedback throughout this research.
METHODS


A mixed-methods experimental design was employed. Fourteen participants were allocated to either an experimental group who were exposed to an audio-tactile map, or a control group exposed to a verbally annotated tactile map. After five minutes' exposure, multiple-choice questions examined participants' recall of the spatial and navigational content. Subsequent semi-structured interviews were conducted to examine their views surrounding the study and the product.
RESULTS


The experimental condition had significantly better overall recall than the control group and higher average scores in all four areas examined by the questions. The interviews suggested that the interactive component offered individuals the freedom to learn the map in several ways and did not restrict them to a sequential and linear approach to learning.
CONCLUSION


Assistive technology can reduce challenges faced by people with visual impairments, and the flexible learning approach offered by the audio-tactile map may be of particular value. Future researchers and assistive technology developers may wish to explore this further.",2020,The experimental condition had significantly better overall recall than the control group and higher average scores in all four areas examined by the questions.,"['People with visual impairments', 'people who were blind or had visual impairments', 'Fourteen participants', 'people with visual impairments']","['interactive audio-tactile map tool', 'Assistive technology', 'interactive audio-tactile map', 'audio-tactile map, or a control group exposed to a verbally annotated tactile map']",['overall recall'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C3876816', 'cui_str': 'Tactile map'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0036605', 'cui_str': 'Assistive equipment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",14.0,0.016012,The experimental condition had significantly better overall recall than the control group and higher average scores in all four areas examined by the questions.,"[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Griffin', 'Affiliation': 'School of Nursing and Midwifery, De Montfort University, Leicester, UK.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Picinali', 'Affiliation': 'Dyson School of Design Engineering, Imperial College London, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Scase', 'Affiliation': 'Division of Psychology, De Montfort University, Leicester, UK.'}]",Brain and behavior,['10.1002/brb3.1650']
3267,32445396,Author response to: Comment on: Comparison of the duration of hospital stay after laparoscopic or open distal pancreatectomy: randomized controlled trial.,,2020,,[],['laparoscopic or open distal pancreatectomy'],['hospital stay'],[],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0911117,,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Björnsson', 'Affiliation': 'Department of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lindhoff Larsson', 'Affiliation': 'Department of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hjalmarsson', 'Affiliation': 'Department of Surgery, Blekinge Hospital, Karlskrona, Sweden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gasslander', 'Affiliation': 'Department of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sandström', 'Affiliation': 'Department of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}]",The British journal of surgery,['10.1002/bjs.11681']
3268,32445429,Cholesterol-lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients: Design of the randomized controlled EVOLVD trial.,"BACKGROUND


Cardiac allograft vasculopathy (CAV) is characterized by diffuse thickening of the arterial intima. Statins reduce the incidence of CAV, but despite the use of statins, CAV remains one of the leading causes of long-term death after heart transplant. Inhibitors of proprotein convertase subtilisin-kexin type 9 (PCSK9) substantially reduce cholesterol levels but have not been tested in heart transplant recipients.
METHODS


The Cholesterol lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients (EVOLVD) trial (ClinicalTrials.gov Identifier: NCT03734211) is a randomized, double-blind trial designed to test the effect of the PCSK9 inhibitor evolocumab on coronary intima thickness in heart transplant recipients. Adults who have received a cardiac transplant within the past 4 - 8 weeks are eligible. Exclusion criteria include an estimated glomerular filtration rate < 20 mL/min/1.73 m 2  , renal replacement therapy, or contraindications to coronary angiography with intravascular ultrasound. 130 patients will be randomized (1:1) to 12-months' treatment with evolocumab or matching placebo. The primary endpoint is the coronary artery intima thickness as measured by intravascular ultrasound.
CONCLUSION


The EVOLVD trial is a randomized clinical trial designed to show whether treatment with the PCSK9 inhibitor evolocumab can ameliorate CAV over the first year after heart transplant.",2020,"Inhibitors of proprotein convertase subtilisin-kexin type 9 (PCSK9) substantially reduce cholesterol levels but have not been tested in heart transplant recipients.
","['Vasculopathy in De-novo heart transplant recipients', '130 patients', 'Exclusion criteria include an estimated glomerular filtration rate < 20 mL/min/1.73 m 2  , renal replacement therapy, or contraindications to coronary angiography with intravascular ultrasound', 'Adults who have received a cardiac transplant within the past 4 - 8 weeks are eligible', 'heart transplant recipients']","['Cholesterol-lowering with EVOLocumab', 'evolocumab or matching placebo', 'PCSK9 inhibitor evolocumab', 'proprotein convertase subtilisin-kexin type 9 (PCSK9']","['cholesterol levels', 'coronary artery intima thickness as measured by intravascular ultrasound', 'cardiac allograft', 'coronary intima thickness']","[{'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertase'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'Kexin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0564471', 'cui_str': 'Allograft heart'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",130.0,0.489633,"Inhibitors of proprotein convertase subtilisin-kexin type 9 (PCSK9) substantially reduce cholesterol levels but have not been tested in heart transplant recipients.
","[{'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Broch', 'Affiliation': 'The Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Gude', 'Affiliation': 'The Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Kristjan', 'Initials': 'K', 'LastName': 'Karason', 'Affiliation': 'The Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Dellgren', 'Affiliation': 'The Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Rådegran', 'Affiliation': 'The Clinic for Heart Failure and Valvular Disease, Skåne University Hospital, Sweden.'}, {'ForeName': 'Grunde', 'Initials': 'G', 'LastName': 'Gjesdal', 'Affiliation': 'The Clinic for Heart Failure and Valvular Disease, Skåne University Hospital, Sweden.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'The Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eiskjaer', 'Affiliation': 'The Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jyri', 'Initials': 'J', 'LastName': 'Lommi', 'Affiliation': 'Helsinki University Hospital Heart and Lung Center, Helsinki, Finland.'}, {'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Lemström', 'Affiliation': 'Helsinki University Hospital Heart and Lung Center, Helsinki, Finland.'}, {'ForeName': 'Arne K', 'Initials': 'AK', 'LastName': 'Andreassen', 'Affiliation': 'The Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'The Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}]",Clinical transplantation,['10.1111/ctr.13984']
3269,30663520,Temporal dynamics of the pharmacological MRI response to subanaesthetic ketamine in healthy volunteers: A simultaneous EEG/fMRI study.,"BACKGROUND


Pharmacological magnetic resonance imaging has been used to investigate the neural effects of subanaesthetic ketamine in healthy volunteers. However, the effect of ketamine has been modelled with a single time course and without consideration of physiological noise.
AIMS


This study aimed to investigate ketamine-induced alterations in resting neural activity using conventional pharmacological magnetic resonance imaging analysis techniques with physiological noise correction, and a novel analysis utilising simultaneously recorded electroencephalography data.
METHODS


Simultaneous electroencephalography/functional magnetic resonance imaging and physiological data were collected from 30 healthy male participants before and during a subanaesthetic intravenous ketamine infusion.
RESULTS


Consistent with previous literature, we show widespread cortical blood-oxygen-level dependent signal increases and decreased blood-oxygen-level dependent signals in the subgenual anterior cingulate cortex following ketamine. However, the latter effect was attenuated by the inclusion of motion regressors and physiological correction in the model. In a novel analysis, we modelled the pharmacological magnetic resonance imaging response with the power time series of seven electroencephalography frequency bands. This showed evidence for distinct temporal time courses of neural responses to ketamine. No electroencephalography power time series correlated with decreased blood-oxygen-level dependent signal in the subgenual anterior cingulate cortex.
CONCLUSIONS


We suggest the decrease in blood-oxygen-level dependent signals in the subgenual anterior cingulate cortex typically seen in the literature is the result of physiological noise, in particular cardiac pulsatility. Furthermore, modelling the pharmacological magnetic resonance imaging response with a single temporal model does not completely capture the full spectrum of neuronal dynamics. The use of electroencephalography regressors to model the response can increase confidence that the pharmacological magnetic resonance imaging is directly related to underlying neural activity.",2019,"No electroencephalography power time series correlated with decreased blood-oxygen-level dependent signal in the subgenual anterior cingulate cortex.
","['30 healthy male participants before and during a subanaesthetic intravenous ketamine infusion', 'healthy volunteers']","['subanaesthetic ketamine', 'ketamine']","['blood-oxygen-level dependent signal', 'blood-oxygen-level']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",30.0,0.060542,"No electroencephalography power time series correlated with decreased blood-oxygen-level dependent signal in the subgenual anterior cingulate cortex.
","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McMillan', 'Affiliation': '1 School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forsyth', 'Affiliation': '1 School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': '2 Department of Anaesthesiology, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Malpas', 'Affiliation': '2 Department of Anaesthesiology, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Maxwell', 'Affiliation': '2 Department of Anaesthesiology, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Dukart', 'Affiliation': '3 F. Hoffmann-La Roche, Pharma Research and Early Development, Roche Innovation Centre Basel, Basel, Switzerland.'}, {'ForeName': 'Joerg F', 'Initials': 'JF', 'LastName': 'Hipp', 'Affiliation': '3 F. Hoffmann-La Roche, Pharma Research and Early Development, Roche Innovation Centre Basel, Basel, Switzerland.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Muthukumaraswamy', 'Affiliation': '1 School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881118822263']
3270,30980923,Exercise as a potential modulator of inflammation in patients with Alzheimer's disease measured in cerebrospinal fluid and plasma.,"BACKGROUND


Neuroinflammation is recognized as part of the pathological progression of Alzheimer's disease (AD), but the molecular mechanisms are still not entirely clear. Systemically, physical exercise has shown to have a positive modulating effect on markers of inflammation. It is not known if this general effect also takes place in the central nervous system in AD. The aim of this study was to investigate the effect of 16 weeks of moderate to high-intensity physical exercise on selected biomarkers of inflammation both systemically and in the CNS, in patients with AD.
METHODS


Plasma and cerebrospinal fluid (CSF) from 198 patients with Alzheimer's disease participating in the Preserving Cognition, Quality of Life, Physical Health and Functional Ability in Alzheimer's Disease: The Effect of Physical Exercise (ADEX) study were analyzed for concentrations of 8‑isoprostane, soluble trigger receptor expressed on myeloid cells 2 (sTREM2), and the MSD v-plex proinflammation panel 1 human containing interferon gamma (IFNγ), Interleukin-10 (IL10), IL12p70, IL13, IL1β, IL2, IL4, IL6, IL8, and tumor necrosis factor alpha (TNFα), before and after a 16-week intervention with physical exercise, and we studied whether changes were modulated by the patients' APOE genotype.
RESULTS


Most inflammatory markers remained unchanged after exercise. We found an increasing effect of 16 weeks of physical exercise on sTREM2 measured in CSF. Further, IL6 in plasma increased in the exercise group after physical exercise (mean relative change 41.03, SD 76.7), compared to controls (-0.97, SD 49.4). In a sub-analysis according to APOE genotype, we found that in ε4 carriers, exercise had a stabilizing effect on IFNγ concentration with a mean relative change of 7.84 (SD 42.6), as compared to controls (114.7 (SD 188.3), p = 0.038.
CONCLUSION


Our findings indicate an effect of physical exercise on markers of neuroinflammation in CSF measured by an increase in sTREM2 in patients with AD. Further, there may be a small inflammatory systemic effect related to physical exercise in patients with AD.",2019,"Further, IL6 in plasma increased in the exercise group after physical exercise (mean relative change 41.03, SD 76.7), compared to controls (-0.97, SD 49.4).","['patients with AD', ""patients with Alzheimer's disease measured in cerebrospinal fluid and plasma"", ""198 patients with Alzheimer's disease participating in the Preserving Cognition, Quality of Life, Physical Health and Functional Ability in Alzheimer's Disease""]","['Physical Exercise (ADEX', 'moderate to high-intensity physical exercise', 'physical exercise']","['concentrations of 8‑isoprostane, soluble trigger receptor expressed on myeloid cells 2 (sTREM2), and the MSD v-plex proinflammation panel 1 human containing interferon gamma (IFNγ), Interleukin-10 (IL10), IL12p70, IL13, IL1β, IL2, IL4, IL6, IL8, and tumor necrosis factor alpha (TNFα', 'markers of neuroinflammation in CSF', 'IFNγ concentration', 'IL6 in plasma']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1143976', 'cui_str': 'TREM2 protein, human'}, {'cui': 'C0268263', 'cui_str': 'Multiple sulfatase deficiency'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0214743', 'cui_str': 'Interleukin 13'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",198.0,0.0843171,"Further, IL6 in plasma increased in the exercise group after physical exercise (mean relative change 41.03, SD 76.7), compared to controls (-0.97, SD 49.4).","[{'ForeName': 'Camilla Steen', 'Initials': 'CS', 'LastName': 'Jensen', 'Affiliation': 'Danish Dementia Research Centre, Department of Neurology, Rigshospitalet University of Copenhagen, DK-2100 Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Denmark. Electronic address: Camilla.steen.jensen@regionh.dk.'}, {'ForeName': 'Justyna Maria', 'Initials': 'JM', 'LastName': 'Bahl', 'Affiliation': 'Department of Bioanalysis, Lundbeck, 2500 Valby, Denmark.'}, {'ForeName': 'Lærke Borg', 'Initials': 'LB', 'LastName': 'Østergaard', 'Affiliation': 'Danish Dementia Research Centre, Department of Neurology, Rigshospitalet University of Copenhagen, DK-2100 Copenhagen, Denmark. Electronic address: Lærke.borg.østergaard@regionh.dk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Høgh', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Denmark; Regional Dementia Research Centre, Department of Neurology, Zealand University Hospital, DK-4000 Roskilde, Denmark. Electronic address: phh@regionsjaelland.dk.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Wermuth', 'Affiliation': 'Dementia Clinic, Department of Neurology, Odense University Hospital, DK-5000 Odense, Denmark. Electronic address: Lene.Wermuth@rsyd.dk.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Heslegrave', 'Affiliation': 'Department of Neurodegenerative Disease, UCL Institute of Neurology, Queen Square, WC1N London, UK; UK Dementia Research Institute at UCL, London WC1E 6BT, UK. Electronic address: a.heslegrave@ucl.ac.uk.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'Department of Neurodegenerative Disease, UCL Institute of Neurology, Queen Square, WC1N London, UK; UK Dementia Research Institute at UCL, London WC1E 6BT, UK; Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at the University of Gothenburg, S-431 80 Mölndal, Sweden; Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, S-431 80 Mölndal, Sweden. Electronic address: henrik.zetterberg@clinchem.gu.se.'}, {'ForeName': 'Niels H H', 'Initials': 'NHH', 'LastName': 'Heegaard', 'Affiliation': 'Department of Clinical Biochemistry, Immunology and Genetics, Statens Serum Institut, Copenhagen, Denmark; Department of Clinical Biochemistry, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Steen Gregers', 'Initials': 'SG', 'LastName': 'Hasselbalch', 'Affiliation': 'Danish Dementia Research Centre, Department of Neurology, Rigshospitalet University of Copenhagen, DK-2100 Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Denmark. Electronic address: Steen.gregers.hasselbalch@regionh.dk.'}, {'ForeName': 'Anja Hviid', 'Initials': 'AH', 'LastName': 'Simonsen', 'Affiliation': 'Danish Dementia Research Centre, Department of Neurology, Rigshospitalet University of Copenhagen, DK-2100 Copenhagen, Denmark. Electronic address: anja.hviid.simonsen@regionh.dk.'}]",Experimental gerontology,['10.1016/j.exger.2019.04.003']
3271,32445670,Long-term Safety and Efficacy of Subcutaneous C1-Inhibitor in Older Patients With Hereditary Angioedema.,"BACKGROUND


Patients ≥65 years old with hereditary angioedema (HAE) due to C1-inhibitor (C1-INH) deficiency may have an altered response to treatment and be at higher risk for treatment-related adverse events (AEs) due to comorbidities and polypharmacy.
OBJECTIVE


Investigate the safety and efficacy of subcutaneous (SC) C1-INH in patients ≥65 years old treated in an open-label extension of a phase 3 trial.
METHODS


Eligible patients (≥4 attacks over 2 consecutive months) were randomized to receive twice-weekly C1-INH (SC) 40 IU/kg or 60 IU/kg for 52 to 140 weeks. Safety endpoints and efficacy outcomes were evaluated for patients aged ≥65 and <65 years.
RESULTS


Of 126 subjects treated, 10 were ≥65 years old (mean age [range], 68 [65-72 years]). Eight of 10 subjects had multiple comorbidities; 6/10 were taking >5 non-HAE-related drugs concomitantly. AEs occurring in >1 subject included injection-site bruising (n = 2, related), injection-site pain (n = 2, related), urinary tract infection (n = 2, unrelated), and diarrhea (n = 2, unrelated). No thromboembolic events or cases of anaphylaxis were reported. Two subjects ≥65 years old experienced unrelated serious AEs (dehydration and hypokalemia in one and pneumonia and an HAE attack leading to hospitalization in another). Six of 9 evaluable subjects were responders, with ≥50% reduction in HAE attacks versus pre-study; 6/10 had <1 attack/4 weeks and 3 were attack-free (median 20-03-0141R1 attack rate, 0.52 attacks/month).
CONCLUSION


C1-INH (SC) was well tolerated and effective in the management of HAE in these subjects ≥65 years old with multiple comorbid conditions and polypharmacy.",2020,No thromboembolic events or cases of anaphylaxis were reported.,"['126 subjects treated', 'Patients ≥65 years old with hereditary angioedema (HAE', 'Eligible patients (≥4 attacks over 2 consecutive months', 'patients ≥65 years old treated in an open-label extension of a phase 3 trial', 'Two subjects ≥65 years old experienced unrelated serious AEs (dehydration and hypokalemia in one and pneumonia and an HAE attack leading to hospitalization in another', 'patients aged ≥65 and <65 years', 'Older Patients With Hereditary Angioedema', 'subjects ≥65 years old with multiple comorbid conditions and polypharmacy', 'Eight of 10 subjects had multiple comorbidities; 6/10 were taking >5 non-HAE-related drugs concomitantly', ' 10 were ≥65 years old (mean age [range], 68 [65-72 years']","['Subcutaneous C1-Inhibitor', 'C1-INH (SC', 'subcutaneous (SC) C1-INH']","['Safety endpoints and efficacy outcomes', 'tolerated and effective', 'urinary tract infection', 'safety and efficacy', 'thromboembolic events', 'HAE attacks']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1446194', 'cui_str': 'Serum C1 esterase inhibitor antigen level'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}]",,0.0321857,No thromboembolic events or cases of anaphylaxis were reported.,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Department of Internal Medicine, Allergy Section, University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, Ohio, USA. Electronic address: bernstja@ucmail.uc.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Schwartz', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Ottawa Allergy Research Corporation and University of Ottawa Medical School, Ottawa, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Baker Allergy, Asthma and Dermatology Research Center, Portland, Oregon, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Clinical Research Center of Alabama, Birmingham, Alabama, USA.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Farkas', 'Affiliation': 'Hungarian Angioedema Reference Center, Third Department of Internal Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Aygören-Pürsün', 'Affiliation': 'Klinikum der Johann Wolfgang-Goethe Universität, Klinik für Kinder- und Jugendmedizin, Frankfurt, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Bygum', 'Affiliation': 'HAE Centre Denmark, Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': 'CSL Behring, King of Prussia, Pennsylvania, USA.'}, {'ForeName': 'Henrike', 'Initials': 'H', 'LastName': 'Feuersenger', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Pragst', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'University of California, San Diego School of Medicine, La Jolla, California, USA.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.05.015']
3272,32445690,"Minocycline and celecoxib as adjunctive treatments for bipolar depression: a multicentre, factorial design randomised controlled trial.","BACKGROUND


Several small studies suggest that the adjunctive use of anti-inflammatory agents might improve depressive symptoms in bipolar disorder. However, there are few well designed, appropriately powered clinical trials assessing the efficacy of these novel treatment strategies. We aimed to assess the efficacy of adjunctive minocycline or celecoxib in this setting.
METHODS


This double-blind, 12-week, randomised, placebo-controlled trial was done in four outpatient psychiatric clinics in Pakistan. Eligible participants were adults (aged 18-65 years) with DSM-5 bipolar disorder (type I or II) and a major depressive episode. In a 2 × 2 factorial design, participants were randomly assigned (1:1:1:1) to receive either active minocycline plus active celecoxib, active minocycline plus placebo celecoxib, placebo minocycline plus active celecoxib, or placebo minocycline plus placebo celecoxib. The primary outcome was the mean change from baseline to week 12 in score on the 17-item Hamilton Depression Rating Scale (HAMD-17), assessed in all randomised participants (missing data were imputed and assumed to be missing at random). The trial was registered with ClinicalTrials.gov, NCT02703363.
FINDINGS


266 (17%) of 1542 patients assessed between May 1, 2016, and March 31, 2019, were randomly assigned to receive minocycline plus celecoxib (n=68), minocycline plus placebo (n=66), celecoxib plus placebo (n=66), or placebo plus placebo (n=66). From baseline to week 12, depressive symptoms as per HAMD-17 reduced in all four groups (from 24·5-25·2 to 11·3-12·8), but these reductions did not differ significantly between the groups. In terms of main effects, reductions in HAMD-17 did not differ for patients treated with minocycline (mean adjusted difference vs non-minocycline 1·48 [95% CI -0·41 to 3·36]; p=0·123) or for celecoxib (mean adjusted difference vs non-celecoxib -0·74 [-2·61 to 1·14]; p=0·443). Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident).
INTERPRETATION


We found no evidence that minocycline or celecoxib was superior to placebo for the treatment of bipolar depression. This large trial casts doubt on the potential therapeutic benefits of adjunctive anti-inflammatory drugs for the acute management of bipolar depression.
FUNDING


Stanley Medical Research Institute.",2020,"Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident).
","['266 (17%) of 1542 patients assessed between May 1, 2016, and March 31, 2019', 'four outpatient psychiatric clinics in Pakistan', 'bipolar depression', 'Eligible participants were adults (aged 18-65 years) with DSM-5 bipolar disorder (type I or II) and a major depressive episode']","['Minocycline and celecoxib', 'active minocycline plus active celecoxib, active minocycline plus placebo celecoxib, placebo minocycline plus active celecoxib, or placebo minocycline plus placebo celecoxib', 'adjunctive minocycline or celecoxib', 'minocycline plus placebo', 'celecoxib plus placebo', 'minocycline', 'placebo plus placebo', 'celecoxib', 'minocycline plus celecoxib', 'placebo']","['HAMD-17', 'depressive symptoms as per HAMD-17', 'mean change from baseline to week 12 in score on the 17-item Hamilton Depression Rating Scale (HAMD-17', 'Rates of serious adverse effects', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.814161,"Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident).
","[{'ForeName': 'Muhammad Ishrat', 'Initials': 'MI', 'LastName': 'Husain', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada. Electronic address: ishrat.husain@camh.ca.'}, {'ForeName': 'Imran B', 'Initials': 'IB', 'LastName': 'Chaudhry', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK; Pakistan Institute of Learning and Living, Karachi, Pakistan; Department of Pyschiatry, Dow University of Health Sciences, Karachi, Pakistan; Ziauddin University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Ameer B', 'Initials': 'AB', 'LastName': 'Khoso', 'Affiliation': 'Pakistan Institute of Learning and Living, Karachi, Pakistan.'}, {'ForeName': 'Muhammad Omair', 'Initials': 'MO', 'LastName': 'Husain', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hodsoll', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Moin A', 'Initials': 'MA', 'LastName': 'Ansari', 'Affiliation': 'Department of Psychiatry, Liaquat University of Medical and Health Sciences, Hyderabad, Pakistan.'}, {'ForeName': 'Haider A', 'Initials': 'HA', 'LastName': 'Naqvi', 'Affiliation': 'Department of Pyschiatry, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Fareed A', 'Initials': 'FA', 'LastName': 'Minhas', 'Affiliation': 'Institute of Psychiatry, Rawalpindi Medical College, Rawalpindi, Pakistan.'}, {'ForeName': 'Andre F', 'Initials': 'AF', 'LastName': 'Carvalho', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Meyer', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Deakin', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30138-3']
3273,32445735,"Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial.","BACKGROUND


Type 2 diabetes is affecting people at an increasingly younger age, particularly in the Middle East and in north Africa. We aimed to assess whether an intensive lifestyle intervention would lead to significant weight loss and improved glycaemia in young individuals with early diabetes.
METHODS


This open-label, parallel-group, randomised controlled trial (DIADEM-I), done in primary care and community settings in Qatar, compared the effects of an intensive lifestyle intervention with usual medical care on weight loss and glycaemic outcomes in individuals with type 2 diabetes, aged 18-50 years, with a short diabetes duration (≤3 years), had a BMI of 27·0 kg/m 2  or more, and who were from the Middle East and north Africa region. Participants were randomly allocated (1:1) either to the intensive lifestyle intervention group or the usual medical care control group by a computer-generated sequence and an online randomisation service. The intensive lifestyle intervention comprised a total diet replacement phase, in which participants were given formula low-energy diet meal replacement products followed by gradual food reintroduction combined with physical activity support, and a weight-loss maintenance phase, involving structured lifestyle support. Participants in the control group received usual diabetes care, which was based on clinical guidelines. The primary outcome was weight loss at 12 months after receiving the assigned intervention. Our analysis was based on the intention-to-treat principle. Key secondary outcomes included diabetes control and remission. The trial was registered with the ISRCTN registry, ISRCTN20754766, and ClinicalTrials.gov, NCT03225339.
FINDINGS


Between July 16, 2017, and Sept 30, 2018, we enrolled and randomly assigned 158 participants (n=79 in each group) to the study. 147 participants (70 in the intervention group and 77 in the control group) were included in the final intention-to-treat analysis population. Between baseline and 12 months, the mean bodyweight of participants in the intervention group reduced by 11·98 kg (95% CI 9·72 to 14·23) compared with 3·98 kg (2·78 to 5·18) in the control group (adjusted mean difference -6·08 kg [95% CI -8·37 to -3·79], p<0·0001). In the intervention group, 21% of participants achieved more than 15% weight loss between baseline and 12 months compared with 1% of participants in the control group (p<0·0001). Diabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR] 12·03 [95% CI 5·17 to 28·03], p<0·0001). 33% of participants in the intervention group had normoglycaemia compared with 4% of participants in the control group (OR 12·07 [3·43 to 42·45], p<0·0001). Five serious adverse events were reported in four participants in the control group; four admissions to hospital because of unanticipated events (supraventricular tachycardia, abdominal pain, pneumonia, and epididymo-orchitis), and one admission to hospital for an anticipanted event (hyperglycaemia).
INTERPRETATION


Our findings show that the intensive lifestyle intervention led to significant weight loss at 12 months, and was associated with diabetes remission in over 60% of participants and normoglycaemia in over 30% of participants. The provision of this lifestyle intervention could allow a large proportion of young individuals with early diabetes to achieve improvements in key cardiometabolic outcomes, with potential long-term benefits for health and wellbeing.
FUNDING


Qatar National Research Fund.",2020,Diabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR],"['147 participants (70 in the intervention group and 77 in the control group) were included in the final intention-to-treat analysis population', 'Between July 16, 2017, and Sept 30, 2018, we enrolled and randomly assigned 158 participants (n=79 in each group) to the study', '12·03', 'young individuals with early diabetes', 'individuals with type 2 diabetes, aged 18-50 years, with a short diabetes duration (≤3 years), had a BMI of 27·0 kg/m 2  or more, and who were from the Middle East and north Africa region', 'early type 2 diabetes (DIADEM-I']","['intensive lifestyle intervention', 'usual diabetes care', 'intensive lifestyle intervention with usual medical care', 'intensive lifestyle intervention group or the usual medical care control group by a computer-generated sequence and an online randomisation service', 'formula low-energy diet meal replacement products followed by gradual food reintroduction combined with physical activity support, and a weight-loss maintenance phase, involving structured lifestyle support']","['weight loss and glycaemic outcomes', 'diabetes control and remission', 'unanticipated events (supraventricular tachycardia, abdominal pain, pneumonia, and epididymo-orchitis), and one admission to hospital for an anticipanted event (hyperglycaemia', 'weight loss', 'diabetes remission', 'normoglycaemia', 'weight loss and improved glycaemia', 'bodyweight and glycaemia', 'Diabetes remission', 'mean bodyweight']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0026068', 'cui_str': 'Middle east country'}, {'cui': 'C0001745', 'cui_str': 'Northern Africa'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0149881', 'cui_str': 'Orchitis and epididymitis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",158.0,0.120849,Diabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR],"[{'ForeName': 'Shahrad', 'Initials': 'S', 'LastName': 'Taheri', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Department of Medicine, Weill Cornell Medicine, New York, NY, USA; Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar. Electronic address: staheri@me.com.'}, {'ForeName': 'Hadeel', 'Initials': 'H', 'LastName': 'Zaghloul', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Chagoury', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Elhadad', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Salma Hayder', 'Initials': 'SH', 'LastName': 'Ahmed', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'El Khatib', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Rasha Abou', 'Initials': 'RA', 'LastName': 'Amona', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'El Nahas', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Suleiman', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Alnaama', 'Affiliation': 'Primary Health Care Corporation, Doha, Qatar.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Al-Hamaq', 'Affiliation': 'Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Charlson', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Martin T', 'Initials': 'MT', 'LastName': 'Wells', 'Affiliation': 'University Department of Statistics and Data Science, Cornell University, Ithaca, New York, NY, USA.'}, {'ForeName': 'Samya', 'Initials': 'S', 'LastName': 'Al-Abdulla', 'Affiliation': 'Primary Health Care Corporation, Doha, Qatar.'}, {'ForeName': 'Abdul Badi', 'Initials': 'AB', 'LastName': 'Abou-Samra', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine Qatar, Qatar Foundation, Doha, Qatar; Qatar Metabolic Institute, Hamad Medical Corporation, Doha, Qatar.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30117-0']
3274,32445736,"A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial.","BACKGROUND


Excess gestational weight gain (GWG) among women with overweight or obesity synergistically increases their already elevated risk of having gestational diabetes, a caesarean delivery, a large for gestational age infant, and post-partum weight retention, and increases their child's risk of obesity. We investigated whether a primarily telehealth lifestyle intervention reduced excess GWG among women with overweight or obesity.
METHODS


We did a randomised controlled trial in five antenatal clinics of Kaiser Permanente; Oakland, San Leandro, Walnut Creek, Fremont, and Santa Clara, CA, USA. Women at 8-15 weeks' gestation with singletons, pre-pregnancy BMI 25·0-40·0 kg/m 2 , and aged 18 years or older were randomly assigned (1:1) to receive the telehealth lifestyle intervention or usual antenatal care. Randomisation was adaptively balanced for age, BMI, and race and ethnicity. Data collectors and investigators were masked to group assignments. The core lifestyle intervention consisted of two in-person and 11 telephone sessions on behavioural strategies to improve weight, diet, and physical activity, and stress management to help women meet a trial goal of gaining at the lower limit of the Institute of Medicine (IOM) guidelines range for total GWG: 7 kg for women with overweight and 5 kg for women with obesity. Usual antenatal care included an antenatal visit at 7-10 weeks' gestation, an additional seven antenatal visits, on average, and periodic health education newsletters, including the IOM GWG guidelines and information on healthy eating and physical activity in pregnancy. The primary outcome was weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population. The trial is registered at ClinicalTrials.gov, NCT02130232.
FINDINGS


Between March 24, 2014, and Sept 26, 2017, 5329 women were assessed for eligibility and 200 were randomly assigned to the lifestyle intervention group and 198 to the usual care group. Analyses included 199 women in the lifestyle intervention group (one lost to follow-up) and 195 in the usual care group (three lost to follow-up). 96 (48%) women in the lifestyle intervention group and 134 (69%) women in the usual care group exceeded Institute of Medicine guidelines for rate of GWG per week (relative risk 0·70, 95% CI 0·59 to 0·83). Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32 kg per week [0·13]; mean between-group difference -0·07 kg per week, 95% CI -0·09 to -0·04). No between-group differences in perinatal complications were observed.
INTERPRETATION


Our evidence-based programme showed that health-care delivery systems could further adapt to meet the needs of their clinical settings to prevent excess GWG and improve healthy behaviours and markers of insulin resistance among women with overweight or obesity by using telehealth lifestyle interventions.
FUNDING


US National Institutes of Health.",2020,"Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32","[""Women at 8-15 weeks' gestation with singletons, pre-pregnancy BMI 25·0-40·0 kg/m 2 , and aged 18 years or older"", 'women with overweight and 5 kg for women with obesity', '199 women in the lifestyle intervention group (one lost to follow-up) and 195 in the usual care group (three lost to follow-up', 'five antenatal clinics of Kaiser Permanente; Oakland, San Leandro, Walnut Creek, Fremont, and Santa Clara, CA, USA', 'women with overweight or obesity', 'women in the lifestyle intervention group and 134 (69%) women in the usual care group exceeded Institute of Medicine guidelines for rate of GWG per week (relative risk 0·70, 95% CI 0·59 to 0·83', 'women with overweight or obesity by using telehealth lifestyle interventions', 'pregnant women with overweight or obesity (GLOW', 'Between March 24, 2014, and Sept 26, 2017, 5329 women were assessed for eligibility and 200 were randomly assigned to the lifestyle intervention group and 198 to the usual care group']","['telehealth lifestyle intervention or usual antenatal care', 'telephone sessions on behavioural strategies to improve weight, diet, and physical activity, and stress management to help women meet a trial goal of gaining at the lower limit of the Institute of Medicine (IOM) guidelines range for total GWG', ""Usual antenatal care included an antenatal visit at 7-10 weeks' gestation, an additional seven antenatal visits, on average, and periodic health education newsletters, including the IOM GWG guidelines and information"", 'primarily telehealth lifestyle intervention', 'telehealth lifestyle intervention']","['perinatal complications', 'weekly rate of GWG', 'weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population', 'gestational weight gain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0330971', 'cui_str': 'Juglans'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4748924', 'cui_str': 'Global developmental delay, lung cysts, overgrowth, Wilms tumor syndrome'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}]","[{'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021621', 'cui_str': 'Institute of Medicine (U.S.)'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",5329.0,0.152039,"Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32","[{'ForeName': 'Assiamira', 'Initials': 'A', 'LastName': 'Ferrara', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA. Electronic address: assiamira.ferrara@kp.org.'}, {'ForeName': 'Monique M', 'Initials': 'MM', 'LastName': 'Hedderson', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Brown', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; Department of Internal Medicine, School of Medicine, University of California, Davis, Sacramento, CA, USA.'}, {'ForeName': 'Samantha F', 'Initials': 'SF', 'LastName': 'Ehrlich', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA; Department of Public Health, University of Tennessee Knoxville, Knoxville, TN, USA.'}, {'ForeName': 'Ai-Lin', 'Initials': 'AL', 'LastName': 'Tsai', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Juanran', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Galarce', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}, {'ForeName': 'Santica', 'Initials': 'S', 'LastName': 'Marcovina', 'Affiliation': 'Northwest Lipid Metabolism and Diabetes Research Laboratories, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Catalano', 'Affiliation': 'Mother Infant Research Institute, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Quesenberry', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30107-8']
3275,32445738,"Flexible insulin therapy with a hybrid regimen of insulin degludec and continuous subcutaneous insulin infusion with pump suspension before exercise in physically active adults with type 1 diabetes (FIT Untethered): a single-centre, open-label, proof-of-concept, randomised crossover trial.","BACKGROUND


People with type 1 diabetes who use continuous subcutaneous insulin infusion (CSII, or insulin pump therapy) often remove their pump before extended periods of exercise, but this approach might result in reduced glycaemic control and increased risk of hyperglycaemia and ketogenesis. We aimed to assess the efficacy and safety of a hybrid approach, in which basal insulin delivery was divided between CSII and a daily injection of insulin degludec.
METHODS


In this single-centre, open-label, proof-of-concept, randomised crossover trial done at the LMC Diabetes & Endocrinology research centre, we recruited physically active and aerobically fit participants aged 18 years or older with type 1 diabetes who were using CSII. Participants were randomly assigned (1:1) by use of a computer-generated sequence to one of two sequences of either usual CSII, involving the continuation of the participant's usual CSII regimen, followed by crossover to hybrid CSII, in which the delivery of the participant's usual daily basal insulin dose was split (50% delivered by CSII and 50% delivered by a once-daily morning injection of 100 U/mL insulin degludec), or the opposite sequence (ie, hybrid CSII followed by crossover to usual CSII). Treatment was not masked to the investigators or participants. For each intervention, participants completed a moderate-intensity and a high-intensity in-clinic exercise session in the first week, followed by four high-intensity and two moderate-intensity home-based exercise sessions in the subsequent 3 weeks. Insulin pumps were suspended or disconnected 60 min before exercise and reconnected immediately after exercise during both treatment regimens. The coprimary outcomes were: (1) time spent in the target control range of 4·0-10·0 mmol/L blood glucose after high-intensity exercise, and (2) time spent in target control range of 4·0-10·0 mmol/L blood glucose after moderate-intensity exercise, measured by continuous glucose monitoring in the 6-h period from the start of the high-intensity and moderate-intensity in-clinic exercise sessions. Outcomes were assessed in a modified intention-to-treat population that included all participants who started both intervention phases and completed all of the in-clinic exercise visits. This trial is registered with ClinicalTrials.gov, NCT03838783, and is complete.
FINDINGS


Between May 15, 2018, and March 5, 2019, we assessed 43 patients for eligibility, of whom 31 were randomly assigned to receive the usual CSII regimen (n=14) or hybrid CSII regimen (n=17) in the first phase (before crossover). The analysis population consisted of 24 participants who completed both study phases. Compared with the usual CSII regimen, participants on the hybrid CSII regimen had a significantly longer time in blood glucose range of 4-10 mmol/L during the 6-h period from the start of both moderate-intensity (mean difference 86 min [95% CI 61-147], p=0·005; percentage time in range 64% [SD 35] vs 40% [35]) and high-intensity in-clinic exercise session (60 min [11-109], p=0·01; 66% [32] vs 50% [27]). Participants on the hybrid CSII regimen also showed a higher time in blood glucose range of 4-10 mmol/L during home-based exercise sessions (mean difference 23 min [95% CI -1 to 46], p=0·055), with significantly lower time spent in hyperglycaemia than participants on the usual CSII regimen (mean difference 25 min [2-48], p=0·04). These exploratory outcomes also showed no significant difference in the amount of time spent in hypoglycaemia, nor the number of hypoglycaemic events, between the two interventions. There were three study-related adverse events reported with the usual CSII regimen (two hypotension events and one nausea event) and four with the hybrid CSII regimen (two hypotension events and two nausea events).
INTERPRETATION


A hybrid regimen of injected insulin degludec and CSII (with pump removal during exercise) appears to be safe and effective in adults with type 1 diabetes who exercise regularly. This approach could offer improved glycaemic control immediately after exercise and should be further assessed in a larger-scale randomised trial.
FUNDING


Novo Nordisk.",2020,"Compared with the usual CSII regimen, participants on the hybrid CSII regimen had a significantly longer time in blood glucose range of 4-10 mmol/L during the 6-h period from the start of both moderate-intensity (mean difference 86 min [95% CI 61-147], p=0·005; percentage time in range 64% [SD 35] vs 40% [35]) and high-intensity in-clinic exercise session (60 min [11-109], p=0·01; 66% [32] vs 50% [27]).","['People with type 1 diabetes who use', '24 participants who completed both study phases', '43 patients for eligibility, of whom 31', 'LMC Diabetes & Endocrinology research centre, we recruited physically active and aerobically fit participants aged 18 years or older with type 1 diabetes who were using CSII', 'physically active adults with type 1 diabetes (FIT Untethered', 'adults with type 1 diabetes who exercise regularly']","['Flexible insulin therapy', 'injected insulin degludec and CSII (with pump removal during exercise', 'usual CSII regimen (n=14) or hybrid CSII regimen', 'continuous subcutaneous insulin infusion (CSII, or insulin pump therapy', 'insulin degludec and continuous subcutaneous insulin infusion with pump suspension before exercise']","['longer time in blood glucose range', 'higher time in blood glucose range', 'time spent in hypoglycaemia, nor the number of hypoglycaemic events', 'efficacy and safety', '1) time spent in the target control range of 4·0-10·0 mmol/L blood glucose after high-intensity exercise, and (2) time spent in target control range of 4·0-10·0 mmol/L blood glucose', 'time spent in hyperglycaemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556454', 'cui_str': 'Exercises regularly'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0585043', 'cui_str': 'Before exercise'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",43.0,0.0906429,"Compared with the usual CSII regimen, participants on the hybrid CSII regimen had a significantly longer time in blood glucose range of 4-10 mmol/L during the 6-h period from the start of both moderate-intensity (mean difference 86 min [95% CI 61-147], p=0·005; percentage time in range 64% [SD 35] vs 40% [35]) and high-intensity in-clinic exercise session (60 min [11-109], p=0·01; 66% [32] vs 50% [27]).","[{'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada. Electronic address: ronnie.aronson@lmc.ca.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Brown', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McGaugh', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, ON, Canada.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Riddell', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30114-5']
3276,32445850,Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain during Intraarticular Injection of the Shoulder: a Randomized Double-Blind Controlled Trial.,"OBJECTIVE


This study was performed to compare the effects of a vapocoolant spray and an eutectic mixture of local anesthetics (EMLA) cream on reducing pain during intraarticular (IA) injection of the shoulder.
DESIGN


Double-blind randomized placebo-controlled clinical trial.
SETTING


University hospital.
PARTICIPANTS


Sixty-three patients who underwent IA injection of the shoulder joint were randomized into the spray group, EMLA group, or placebo group.
INTERVENTION


Placebo cream + vapocoolant spray (spray group), EMLA cream + placebo spray (EMLA group), or placebo cream + placebo spray (placebo group) before IA injection.
MAIN OUTCOME MEASURES


A 100-mm visual analog scale (VAS) for injection pain and 5-point Likert scales for participant satisfaction and preference for repeated use were administered immediately after IA injection.
RESULTS


The VAS scores for pain during IA injection were 30.0 (95% confidence interval: 19.7-41.2) in the spray group, 50.0 (37.7-63.0) in the EMLA group, and 53.8 (41.6-65.0) in the placebo group (F = 6.403, P < 0.01). The spray group showed significantly better Likert scale scores than the placebo group for participant satisfaction (P = 0.003) and preference for repeated use (P < 0.001).
CONCLUSIONS


Vapocoolant spray was effective in reducing pain during IA injection of the shoulder.",2020,"The spray group showed significantly better Likert scale scores than the placebo group for participant satisfaction (P = 0.003) and preference for repeated use (P < 0.001).
","['Sixty-three patients who underwent IA injection of the shoulder joint', 'Pain during Intraarticular Injection of the Shoulder', 'University hospital']","['EMLA', 'vapocoolant spray and an eutectic mixture of local anesthetics (EMLA) cream', 'Placebo cream + vapocoolant spray (spray group), EMLA cream + placebo spray (EMLA group), or placebo cream + placebo spray (placebo', 'Vapocoolant spray', 'Vapocoolant Spray and Topical Anesthetic Cream', 'placebo']","['pain during intraarticular (IA) injection', '100-mm visual analog scale (VAS) for injection pain and 5-point Likert scales for participant satisfaction and preference for repeated use', 'pain', 'VAS scores for pain', 'Likert scale scores']","[{'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",63.0,0.716197,"The spray group showed significantly better Likert scale scores than the placebo group for participant satisfaction (P = 0.003) and preference for repeated use (P < 0.001).
","[{'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Moon', 'Affiliation': ""Department of Anesthesiology and Pain Medicine (Moon), Catholic University Seoul St. Mary's hospital.""}, {'ForeName': 'Sang-Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Soonchunhyang University Hospital, Bucheon. Electronic address: sanghyunkim71@gmail.com.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Seok', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Soonchunhyang University Hospital, Bucheon.'}, {'ForeName': 'Seung Yeol', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Soonchunhyang University Hospital, Bucheon.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.04.021']
3277,32445902,"The impact of height-adjustable desks and classroom prompts on classroom sitting time, social, and motivational factors among adolescents.","PURPOSE


This quasi-experimental study examined the impact of height-adjustable desks in combination with prompts to break up prolonged sitting time during class time and identified social and motivational factors associated with breaking up sitting time among adolescents. Teachers' perceptions of strategies were also examined.
METHODS


Over 17 weeks, 1 classroom in a government secondary school in Melbourne, Australia, was equipped with 27 height-adjustable desks and prompts (posters and desk stickers) to break up classroom sitting time. Teachers received professional development in the use of the desks and prompts. One group of adolescents (n = 55) had 2-5 lessons/week using the height-adjustable desks in an intervention classroom, and a comparison group matched by year level and subject (n = 50) was taught in traditional ""seated"" classrooms. Adolescents wore an activPAL monitor at baseline (T0), 4 weeks (T1), and 17 weeks (T2) and completed a survey at T0 and T2. Six teachers participated in interviews at T2. Effect sizes were calculated (d).
RESULTS


Linear mixed models found that, compared to the traditional ""seated"" classrooms, the adolescents in the intervention classroom had significantly lower sitting time (T1: -9.7 min/lesson, d = -0.96; T2: -6.7 min/lesson, d = -0.70) and time spent in sitting bouts >15 min (T2: -11 min/lesson, d = -0.62) and had significantly higher standing time (T1: 7.3 min/lesson, d = 0.84; T2: 5.8 min/lesson, d = 0.91), number of breaks from sitting (T1: 1.3 breaks/lesson, d = 0.49; T2: 1.8 breaks/lesson, d = 0.67), and stepping time (T1: 2.5 min/lesson, d = 0.66). Intervention classroom adolescents reported greater habit strength (d = 0.58), self-efficacy for breaking up sitting time (d = 0.75), and indicated that having a teacher/classmate remind them to stand as helpful (d = 0.50).
CONCLUSION


This intervention shows promise for targeting sitting behaviors in the classroom and indicates that incorporating social and motivational strategies may further enhance outcomes.",2020,"Intervention classroom adolescents reported greater habit strength (d = 0.58), self-efficacy for breaking up sitting time (d = 0.75), and indicated that having a teacher/classmate remind them to stand as helpful (d = 0.50).
","['Six teachers participated in interviews at T2', 'adolescents']",[],"['standing time', 'habit strength', 'self-efficacy for breaking up sitting time', 'sitting time', 'classroom sitting time, social, and motivational factors', 'stepping time', 'time spent in sitting bouts >15 min', 'number of breaks from sitting']","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0445131', 'cui_str': 'Number of breaks'}]",6.0,0.0132516,"Intervention classroom adolescents reported greater habit strength (d = 0.58), self-efficacy for breaking up sitting time (d = 0.75), and indicated that having a teacher/classmate remind them to stand as helpful (d = 0.50).
","[{'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Sudholz', 'Affiliation': 'Pomegranate Community Mental Health, St John of God Social Outreach, Ballarat, VIC 3350, Australia.'}, {'ForeName': 'Ana María Contardo', 'Initials': 'AMC', 'LastName': 'Ayala', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia. Electronic address: a.contardoayala@deakin.edu.au.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Timperio', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia; Physical Activity Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia; Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC 3000, Australia.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Conroy', 'Affiliation': 'Department of Kinesiology, Pennsylvania State University, University Park, PA 16802, USA; Department of Preventive Medicine, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Abbott', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia.'}, {'ForeName': 'Bernie', 'Initials': 'B', 'LastName': 'Holland', 'Affiliation': 'The Australian Council for Health and Physical Education and Recreation, Abbotsford, VIC 3067, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Arundell', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3128, Australia.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.05.002']
3278,32445952,"Low-fat, High-fiber Diet Reduces Markers of Inflammation and Dysbiosis and Improves Quality of Life in Patients With Ulcerative Colitis.","BACKGROUND & AIMS


A high-fat diet has been associated with increased risk of ulcerative colitis (UC). We studied the effects of a low-fat, high-fiber diet (LFD) vs an improved standard American diet (iSAD, included higher quantities of fruits, vegetables, and fiber than a typical SAD). We collected data on quality of life, markers of inflammation, and fecal markers of intestinal dysbiosis in patients with UC.
METHODS


We analyzed data from a parallel-group, cross-over study of 17 patients with UC in remission or mild disease (with a flare within the last 18 months), from February 25, 2015 through September 11, 2018. Participants were randomly assigned to 2 groups and received a LFD (10% of calories from fat) or an iSAD (35%-40% of calories from fat) for the first 4-week period, followed by a 2-week wash-out period, and then switched to the other diet for 4 weeks. All diets were catered and delivered to patients' homes, and each participant served as her or his own control. Serum and stool samples were collected at baseline and week 4 of each diet and analyzed for markers of inflammation. We performed 16s rRNA sequencing and untargeted and targeted metabolomic analyses on stool samples. The primary outcome was quality of life, which was measured by the short inflammatory bowel disease (IBD) questionnaire at baseline and week 4 of the diets. Secondary outcomes included changes in short-form 36 health survey, partial Mayo score, markers of inflammation, microbiome and metabolome analysis, and adherence to the diet.
RESULTS


Participants' baseline diets were unhealthier than either study diet. All patients remained in remission throughout the study period. Compared to baseline, the iSAD and LFD each increased quality of life, based on the short IBD questionnaire and short-form 36 health survey scores (baseline short IBD questionnaire score, 4.98; iSAD, 5.55; LFD, 5.77; baseline vs iSAD P=.02; baseline vs LFD P=.001). Serum amyloid A significantly decreased from 7.99 mg/L at baseline to 4.50 mg/L after LFD (P=.02) but did not decrease significantly compared to iSAD (7.20 mg/L; iSAD vs LFD, P=.07). Serum level of C-reactive protein decreased numerically from 3.23 mg/L at baseline to 2.51 mg/L after LFD (P=.07). Relative abundance of Actinobacteria in fecal samples decreased from 13.69% at baseline to 7.82% after LFD (P=.017), whereas relative abundance of Bacteroidetes increased from 14.6% at baseline to 24.02% on LFD (P=.015). Relative abundance of Faecalibacterium prausnitzii was higher after 4 weeks on the LFD (7.20%) compared with iSAD (5.37%; P=.04). Fecal levels of acetate (an anti-inflammatory metabolite) increased from a relative abundance of 40.37 at baseline to 42.52 on the iSAD and 53.98 on the LFD (baseline vs LFD P=.05; iSAD vs LFD, P=.09). Fecal level of tryptophan decreased from a relative abundance of 1.33 at baseline to 1.08 on the iSAD (P=.43) but increased to a relative abundance of 2.27 on the LFD (baseline vs LFD P=.04; iSAD vs LFD P=.08); fecal levels of lauric acid decreased after LFD (baseline, 203.4; iSAD, 381.4; LFD, 29.91; baseline vs LFD P=.04; iSAD vs LFD P=.02).
CONCLUSIONS


In a cross-over study of patients with UC in remission, we found that a catered, LFD or iSAD were each well tolerated and increased quality of life. However, the LFD decreased markers of inflammation and reduced intestinal dysbiosis in fecal samples. Dietary interventions might therefore benefit patients with UC in remission. ClinicalTrials.gov no: NCT04147598.",2020,"Compared to baseline, the iSAD and LFD each increased quality of life, based on the short IBD questionnaire and short-form 36 health survey scores (baseline short IBD questionnaire score, 4.98; iSAD, 5.55; LFD, 5.77; baseline vs iSAD P=.02; baseline vs LFD P=.001).","['patients with UC in remission', '17 patients with UC in remission or mild disease (with a flare within the last 18 months), from February 25, 2015 through September 11, 2018', 'Patients', 'patients with UC']","['Low-fat, High-fiber Diet', 'low-fat, high-fiber diet (LFD) vs an improved standard American diet (iSAD', 'LFD (10% of calories from fat) or an iSAD']","['relative abundance of Bacteroidetes', 'quality of life, based on the short IBD questionnaire and short-form 36 health survey scores (baseline short IBD questionnaire score', 'Serum amyloid', 'LFD decreased markers of inflammation and reduced intestinal dysbiosis', 'quality of life, markers of inflammation, and fecal markers of intestinal dysbiosis', 'Serum and stool samples', 'risk of ulcerative colitis (UC', 'Inflammation and Dysbiosis and Improves Quality of Life', 'changes in short-form 36 health survey, partial Mayo score, markers of inflammation, microbiome and metabolome analysis, and adherence to the diet', 'Serum level of C-reactive protein', 'Relative abundance of Actinobacteria in fecal samples', 'Relative abundance of Faecalibacterium prausnitzii', 'quality of life, which was measured by the short inflammatory bowel disease (IBD) questionnaire', 'Fecal levels of acetate (an anti-inflammatory metabolite', 'Fecal level of tryptophan', 'fecal levels of lauric acid', 'tolerated and increased quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3697010', 'cui_str': 'Ulcerative colitis in remission'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0301568', 'cui_str': 'High residue diet'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0301568', 'cui_str': 'High residue diet'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4287543', 'cui_str': 'Intestinal dysbiosis'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C3658208', 'cui_str': 'Dysbiosis'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0600148', 'cui_str': 'Class Actinobacteria'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0317558', 'cui_str': 'Faecalibacterium prausnitzii'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0023139', 'cui_str': 'Lauric acid'}]",17.0,0.0684843,"Compared to baseline, the iSAD and LFD each increased quality of life, based on the short IBD questionnaire and short-form 36 health survey scores (baseline short IBD questionnaire score, 4.98; iSAD, 5.55; LFD, 5.77; baseline vs iSAD P=.02; baseline vs LFD P=.001).","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fritsch', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA; Department of Microbiology and Immunology, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garces', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Quintero', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Pignac-Kobinger', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Santander', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Fernández', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Yuguang J', 'Initials': 'YJ', 'LastName': 'Ban', 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Deukwoo', 'Initials': 'D', 'LastName': 'Kwon', 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA; Division of Biostatistics, Department of Public Health Sciences, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Phillips', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Knight', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Mao', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St Paul, Minnesota, USA.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Santaolalla', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Xi S', 'Initials': 'XS', 'LastName': 'Chen', 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA; Division of Biostatistics, Department of Public Health Sciences, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Mukil', 'Initials': 'M', 'LastName': 'Maruthamuthu', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Solis', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Oriana M', 'Initials': 'OM', 'LastName': 'Damas', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Kerman', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Amar R', 'Initials': 'AR', 'LastName': 'Deshpande', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St Paul, Minnesota, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Abreu', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA; Department of Microbiology and Immunology, University of Miami - Leonard Miller School of Medicine, Miami, FL, USA. Electronic address: Mabreu1@med.miami.edu.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.05.026']
3279,32445969,How do oncoming traffic and cyclist lane position influence cyclist overtaking by drivers?,"Overtaking cyclists is challenging for drivers because it requires a well-timed, safe interaction between the driver, the cyclist, and the oncoming traffic. Previous research has investigated this manoeuvre in different experimental environments, including naturalistic driving, naturalistic cycling, and simulator studies. These studies highlight the significance of oncoming traffic-but did not extensively examine the influence of the cyclist's position within the lane. In this study, we performed a test-track experiment to investigate how oncoming traffic and position of the cyclist within the lane influence overtaking. Participants overtook a robot cyclist, which was controlled to ride in two different lateral positions within the lane. At the same time, an oncoming robot vehicle was controlled to meet the participant's vehicle with either 6 or 9 s time-to-collision. The order of scenarios was randomised over participants. We analysed safety metrics for the four different overtaking phases, reflecting drivers' safety margins to rear-end, head-on, and side-swipe collisions, in order to investigate the two binary factors: 1) time gap between ego vehicle and oncoming vehicle, and 2) cyclist lateral position. Finally, the effects of these two factors on the safety metrics and the overtaking strategy (either flying or accelerative depending on whether the overtaking happened before or after the oncoming vehicle had passed) were analysed. The results showed that, both when the cyclist rode closer to the centre of the lane and when the time gap to the oncoming vehicle was shorter, safety margins for all potential collisions decreased. Under these conditions, drivers-particularly female drivers-preferred accelerative over flying manoeuvres. Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.",2020,Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.,[],[],[],[],[],[],,0.0264438,Bayesian statistics modelled these results to inform the development of active safety systems that can support drivers in safely overtaking cyclists.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rasch', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: alexander.rasch@chalmers.se.'}, {'ForeName': 'Christian-Nils', 'Initials': 'CN', 'LastName': 'Boda', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: christian-nils.boda@chalmers.se.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Thalya', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden; Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: prateek.thalya@veoneer.com.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Aderum', 'Affiliation': 'Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: tobias.aderum@veoneer.com.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Knauss', 'Affiliation': 'Veoneer Research, Veoneer Sweden AB, Wallentinsvägen 22, 44737 Vårgårda, Sweden. Electronic address: alessia.knauss@veoneer.com.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Dozza', 'Affiliation': 'Department of Mechanics and Maritime Sciences, Chalmers University of Technology, Hörselgången 4, 41756 Göteborg, Sweden. Electronic address: marco.dozza@chalmers.se.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105569']
3280,32445975,Wii training versus non-Wii task-specific training on motor learning in children with developmental coordination disorder: A randomized controlled trial.,"BACKGROUND


Wii-based interventions have shown significant benefits in motor learning for children with developmental coordination disorder (DCD); however, studies comparing the effects of Wii interventions versus matched non-Wii interventions, such as task-specific training (TST), are scarce.
OBJECTIVE


We compared motor learning in children with DCD who participated in 12 sessions of Wii-based training and those participating in 12 closely matched non-Wii TST sessions as well as when the highest improvements in performance occurred.
METHODS


In total, 32 children with DCD (16 per group) were randomly allocated to receive the Wii intervention or TST during 12 sessions. Motor learning was assessed in 3 consecutive phases during the intervention and was determined by the mean of the games scores obtained in the 1) first 4 sessions, 2) intermediate 4 sessions, and 3) last 4 sessions. Six different tasks (table tennis, frisbee, archery, bowling, tightrope walking/balance beam, and marble balance/balance disc) were performed in every session. Each session lasted 42 min (time on task).
RESULTS


Wii training and TST elicited improvements in motor learning, as assessed by increased scores with the frisbee and marble balance/balance disc tasks. However, Wii training elicited better performance in the archery and bowling tasks, whereas only TST elicited improvements in the balance beam and table tennis tasks.
CONCLUSION


Wii training is not always superior to non-Wii training, and improvements are based on the type of task trained. Thus, each type of intervention benefits a certain skill.",2020,"Wii training is not always superior to non-Wii training, and improvements are based on the type of task trained.","['children with developmental coordination disorder (DCD', 'children with DCD who participated in 12 sessions of Wii-based training and those participating in 12 closely matched non', 'children with developmental coordination disorder', '32 children with DCD (16 per group']","['Wii training versus non-Wii task-specific training', 'motor learning', 'Wii training', 'Wii TST sessions', 'Wii intervention or TST']","['scores with the frisbee and marble balance/balance disc tasks', 'motor learning', 'Motor learning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205689', 'cui_str': 'Marble'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",32.0,0.0193506,"Wii training is not always superior to non-Wii training, and improvements are based on the type of task trained.","[{'ForeName': 'Jorge Lopes Cavalcante', 'Initials': 'JLC', 'LastName': 'Neto', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil; Departament of Human Sciences, Universidade do Estado da Bahia, Jacobina, Bahia, Brazil. Electronic address: jorgelcneto@hotmail.com.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Steenbergen', 'Affiliation': 'Departamento Kinesiologia, Universidad Católica del Maule, Talca, Maule, Chile.'}, {'ForeName': 'Antonio Roberto', 'Initials': 'AR', 'LastName': 'Zamunér', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Tudella', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.03.013']
3281,32446108,Cortisol awakening response in PTSD treatment: Predictor or mechanism of change.,"PTSD is associated with abnormalities in hypothalamic-pituitary-adrenal (HPA) axis activity. This includes enhanced HPA axis negative feedback, attenuated cortisol awakening response, and attenuated cortisol response to personal trauma script. Whether HPA axis function predicts treatment response or treatment related symptom reduction in PTSD remains unclear. In addition, the relative effects of different treatment modalities (i.e., medication and psychotherapy) on HPA axis is unclear. To address this gap in knowledge, the PROGrESS study examined cortisol awakening response across treatment in Veterans with chronic PTSD randomized to receive Prolonged Exposure + Placebo (PE + PLB), Sertraline + PE (SERT + PE) or Sertraline + Enhanced Medication Management (SERT + EMM). Salivary cortisol awakening response (CAR) was assessed at baseline, mid-treatment (week 6 and 12), post-treatment (week 24) and follow-up (week 36 and 52). Among males at baseline, combat veterans with PTSD showed lower CAR Area Under the Curve Increase (AUCi; M = 3.15, SD = 9.57) than Combat controls (M = 7.63, SD = 9.07; p = .02), demonstrating combat veterans with PTSD have a less responsive system than combat controls. Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03). When controlling for PTSD severity, higher baseline CAR AUCi was related to attenuated reduction in PTSD and lower likelihood of high treatment response over treatment (z = -2.06, p = .04).",2020,"Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03).",['Veterans with chronic PTSD'],"['Prolonged Exposure + Placebo (PE + PLB), Sertraline + PE (SERT + PE) or Sertraline + Enhanced Medication Management (SERT + EMM']","['lower CAR Area Under the Curve Increase (AUCi', 'enhanced HPA axis negative feedback, attenuated cortisol awakening response', 'cortisol awakening response', 'Salivary cortisol awakening response (CAR', 'Cortisol awakening response', 'Higher PTSD severity', 'CAR AUCi']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}]","[{'cui': 'C0740379', 'cui_str': 'Cortisol decreased'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0100699,"Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03).","[{'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Atlanta VA Healthcare System, 1670 Clairmont Road, Decatur, GA, 30033, Georgia; Emory University School of Medicine, 12 Executive Park, 3rdFloor, Atlanta, GA, 30029, Georgia. Electronic address: sheila.a.m.rauch@emory.edu.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'King', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'University of Michigan, Consulting for Statistics, Computing and Analytics Research, 3550 Rackham, 950 E. Washington Street, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'University of Michigan, Consulting for Statistics, Computing and Analytics Research, 3550 Rackham, 950 E. Washington Street, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Rajaram', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Venners', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; National Center for PTSD, Dissemination and Training Division, 795 Willow Road, Menlo Park, CA 94025, United States.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'New York University Medical School, Department of Psychiatry, One Park Avenue 8thFloor, New York, NY 10016, United States; Massachusetts General Hospital, Department of Psychiatry, One Bowdoin Square, 6th Floor, Boston, MA 02114, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hamner', 'Affiliation': 'Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston, SC, 29401, United States; Medical University of South Carolina, Department of Psychiatry, 67 President Street, Charleston, SC 29425, United States.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, United States; Texas A&M Health Science Center, Department of Psychiatry and Behavioral Science, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104714']
3282,32446145,Thyroid hormones ratio is a major prognostic marker in advanced metastatic colorectal cancer: Results from the phase III randomised CORRECT trial.,"BACKGROUND


Free triiodothyronine (FT3)/free thyroxine (FT4) ratio is an index estimating the peripheral activity of thyroid hormones. In a previous experience, we identified a prognostic role for FT3/FT4 ratio in chemorefractory patients treated with regorafenib. Therefore, we planned this post hoc analysis of the phase III CORRECT trial of regorafenib versus placebo.
METHODS


Seven hundred fifty-eight out of 760 randomised patients (503 in the regorafenib and 255 in the placebo arm) were evaluable for the present analyses, based on availability of FT3 and FT4 baseline values. Co-primary objectives were to explore the predictive role of FT3/FT4 ratio in patients treated with regorafenib compared with placebo and to validate the prognostic value of FT3/FT4 ratio in the CORRECT trial.
RESULTS


For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively. Hazard ratio (HR) for OS was 0.40 (p < 0.0001) when comparing intermediate versus low and 0.32 (p < 0.0001) when comparing high versus low FT3/FT4 ratio. In the placebo arm, median OS was 3.3, 5.6 and 7.7 months, in the three subgroups. HR for OS was 0.47 (p < 0.0001) when comparing intermediate versus low and 0.33 (p < 0.0001) when comparing high versus low. FT3/FT4 ratio retained its association with OS in the multivariate model in both arms.
CONCLUSIONS


While rejecting the predictive effect of baseline FT3/FT4 ratio, present data strengthen the prognostic role of the ratio, pave the way for direct clinical application, underline the need for a better biological understanding and suggest possible therapeutic implications for thyroid hormones.",2020,"For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively.","['Seven hundred fifty-eight out of 760 randomised patients (503 in the regorafenib and 255 in the', 'advanced metastatic colorectal cancer']","['regorafenib', 'regorafenib versus placebo', 'Thyroid hormones ratio', 'triiodothyronine (FT3)/free thyroxine ', 'placebo']","['Hazard ratio (HR) for OS', 'median OS', 'median overall survival (OS', 'availability of FT3 and FT4 baseline values', 'FT3/FT4 ratio']","[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",760.0,0.121696,"For patients randomised to regorafenib, median overall survival (OS) was 4.0, 7.5 and 9.8 months in low, intermediate and high FT3/FT4 ratio subgroups, respectively.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pasqualetti', 'Affiliation': 'Department of Clinical & Experimental Medicine, Geriatrics Unit, University of Pisa, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Schirripa', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dochy', 'Affiliation': 'Bayer Healthcare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Fassan', 'Affiliation': 'Department of Medicine (DIMED), Surgical Pathology & Cytopathology Unit, University of Padua, Padua, Italy.'}, {'ForeName': 'Pina', 'Initials': 'P', 'LastName': 'Ziranu', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Puzzoni', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Scartozzi', 'Affiliation': 'Department of Medical Science and Public Health, Medical Oncology Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Alberti', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Monzani', 'Affiliation': 'Department of Clinical & Experimental Medicine, Geriatrics Unit, University of Pisa, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Department of Oncology, Unit of Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. Electronic address: fotios.loupakis@iov.veneto.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.023']
3283,32446158,Efficacy of mobile app-based interactive cognitive behavioral therapy using a chatbot for panic disorder.,"BACKGROUND


Cognitive behavioral therapy (CBT) is a well-established treatment for panic disorder, but many fewer patients receive this treatment compared to medication-based therapy. Mobile app-based interactive CBT using a chatbot can increase patient access to CBT. We performed a preliminary study to determine whether short-term use of a newly developed chatbot is feasible and effective for relieving panic symptoms.
METHOD


Forty-one patients were randomly assigned to either a chatbot group (n = 21) or control group (n = 20) for a period of 4 weeks. The chatbot group was guided in the use of the chatbot application, while the control group was provided with a book on panic disorder.
MAIN RESULTS


The severity of panic disorder was significantly decreased in the chatbot group, but not in the control group. The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group.
DISCUSSION AND CONCLUSION


We found that mobile app-based interactive CBT using the chatbot was feasible and effective for reducing the severity of panic symptoms. Using this novel approach to provide CBT would allow clinicians to effect positive therapeutic outcomes with easy accessibility, interactivity, and self-management for patients with panic symptoms.",2020,"The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group.
","['panic disorder', 'patients with panic symptoms', 'Forty-one patients']","['mobile app-based interactive CBT', 'chatbot group (n\u202f=\u202f21) or control group', 'mobile app-based interactive cognitive behavioral therapy', 'Cognitive behavioral therapy (CBT', 'Mobile app-based interactive CBT']","['severity of panic symptoms', 'severity of panic disorder', 'control helplessness score', 'social phobia score']","[{'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018897', 'cui_str': 'Learned Helplessness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]",41.0,0.0195038,"The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group.
","[{'ForeName': 'Jooyoung', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea; Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sooah', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyunji', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Jin', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea; Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: jaejkim@yonsei.ac.kr.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104171']
3284,32446164,Determination of levels of oxidative stress and nitrosative stress in patients with epilepsy.,"BACKGROUND


Epilepsy is one of the most common neurological diseases. The underlying pathophysiological mechanisms in epilepsy are still unknown. Oxidative stress is believed to be one of the factors involved in the pathogenesis of epileptogenesis. In various pathophysiological conditions, reactive nitrogen species (RNS) such as nitrogen and peroxynitrite are produced and these RNSs can bind to free nucleosides and nucleotides or to nucleosides and nucleotides existing in the DNA/RNA structure. 8-Nitroguanine (8-NG) is a typical DNA nucleobase product of nitrosative damage generated by RNS. It has been proposed that F2-isoprostanes, in particular 8-iso-Prostaglandin F2α (8-isoPGF2α), are specific, reliable and non-invasive biomarkers of lipid peroxidation in vivo. In the present study, we compared the levels of lipid oxidative stress biomarker 8-isoPGF2α and nitrosative stress DNA biomarker 8-NG in patients with epilepsy undergoing antiepileptic drug (AEDs) treatment and with those in healthy participants.
METHODS


The present study comprised 90 patients aged between 17 and 53 who were admitted to the Neurology Clinic of Cumhuriyet University and diagnosed with epilepsy. The patients were assigned into the intervention (n = 45) and control (n = 45) groups. Of the participants in the intervention group, 37.7% (n = 17) were treated with levetiracetam (LEV), 33.3% (n = 15) with valproic acid (VA) and 29% (n = 13) with carbamazepine. Serum 8-iso-PGF2α and 8-NG levels of the participants in the intervention and control groups were determined by ELISA.
RESULTS


There was no significant difference between the medication (LEV, VA, Carbamazepine) used by the participants and their 8-iso-PGF2α and 8-NG levels (p > 0.05). However, 8-iso-PGF2α and 8-NG were significantly higher in the participants in the intervention than in the participants in the control group (p < 0.001).
CONCLUSION


Our study demonstrated that there was an increase in oxidative and nitrosative stres markers in patients with epilepsy. There was no significant difference between the 8-iso-PGF2α and 8-NG levels of the participants taking three different AEDs.",2020,"However, 8-iso-PGF2α and 8-NG were significantly higher in the participants in the intervention than in the participants in the control group (p < 0.001).
","['patients with epilepsy undergoing antiepileptic drug (AEDs) treatment and with those in healthy participants', 'patients with epilepsy', '90 patients aged between 17 and 53 who were admitted to the Neurology Clinic of Cumhuriyet University and diagnosed with epilepsy']","['levetiracetam (LEV', 'valproic acid (VA', 'lipid oxidative stress biomarker 8-isoPGF2α and nitrosative stress DNA biomarker 8-NG', 'carbamazepine', '8-Nitroguanine']","['Serum 8-iso-PGF2α and 8-NG levels', 'oxidative stress and nitrosative stress', 'medication (LEV, VA, Carbamazepine', '8-iso-PGF2α and 8-NG', '8-iso-PGF2α and 8-NG levels', 'oxidative and nitrosative stres markers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C4505047', 'cui_str': 'Stress, Nitrosative'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0381956', 'cui_str': '8-nitroguanine'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0381956', 'cui_str': '8-nitroguanine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C4505047', 'cui_str': 'Stress, Nitrosative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",90.0,0.0414708,"However, 8-iso-PGF2α and 8-NG were significantly higher in the participants in the intervention than in the participants in the control group (p < 0.001).
","[{'ForeName': 'Serpil', 'Initials': 'S', 'LastName': 'Ersan', 'Affiliation': 'Nigde Ömer Halisdemir University, Medical Faculty, Department of Biochemistry, Niğde, Turkey. Electronic address: serpilersan@gmail.com.'}, {'ForeName': 'Burhanettin', 'Initials': 'B', 'LastName': 'Cigdem', 'Affiliation': 'Sivas Cumhuriyet University, Medical Faculty, Department of Neurology, Sivas, Turkey.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Bakir', 'Affiliation': 'Sivas Cumhuriyet University, Medical Faculty, Department of Biochemistry, Sivas, Turkey.'}, {'ForeName': 'H Okan', 'Initials': 'HO', 'LastName': 'Dogan', 'Affiliation': 'Sivas Cumhuriyet University, Medical Faculty, Department of Biochemistry, Sivas, Turkey.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106352']
3285,32442118,"Effects of kinesio taping on pain, paresthesia, functional status, and overall health status in patients with symptomatic thoracic outlet syndrome: A single-blind, randomized, placebo-controlled study.","OBJECTIVE


This study aimed to assess the effects of kinesio taping (KT) on pain, paresthesia, functional status, and overall health status in patients with symptomatic thoracic outlet syndrome (sTOS).
METHODS


A single-blind placebo-controlled design was employed in this study. The study duration was defined as 12 months. Analyses were performed on 60 patients with sTOS randomly assigned to KT (4 men and 26 women; mean age=33.5 years, range=20-46 years) and control groups (5 men and 25 women; mean age=26 years, range=20-43 years). KT was applied to the KT group three times. The control group received placebo taping. Pain and paresthesia were evaluated using the visual analogue scale (VAS) pain (10 cm) and VAS paresthesia (10 cm). The upper limb function was assessed using the disabilities of the arm, shoulder, and hand (DASH) questionnaire. The overall health status was evaluated based on the Nottingham Health Profile (NHP). Each assessment was carried out at baseline (t0), posttreatment (t1), and 8 weeks after baseline (t2).
RESULTS


In the KT group, except the social isolation domain of the NHP, all outcome measures showed improvement from t0 to t1. At the second follow-up visit (t2), improvements remained visible compared with baseline. However, none of the variables improved from t1 to t2. Otherwise, all measures deteriorated slightly, and the deteriorations in VAS for pain, NHP pain, NHP sleep, and NHP physical abilities were statistically significant (p=0.041, p=0.048, p=0.013, and p=0.016, respectively). In the control group, only VAS for paresthesia and NHP emotional reaction showed improvement over time (p=0.002 and p=0.044, respectively). When changes in outcome measures between the two groups were compared, except NHP emotional reaction and NHP social isolation, median changes (from t0 to t1) were higher in the KT group than in the control group (p<0.05 for all variables). Regarding VAS pain, VAS paresthesia, DASH, and three NHP domains (energy level, pain, and physical abilities), changes from t0 to t2 were also higher in the KT group (p<0.05 for all variables).
CONCLUSION


KT can provide benefits in terms of relieving pain and paresthesia, as well as improving the upper limb function and quality of life in patients with sTOS.
LEVEL OF EVIDENCE


Level II, Therapeutic study.",2020,"In the KT group, except the social isolation domain of the NHP, all outcome measures showed improvement from t0 to t1.","['patients with symptomatic thoracic outlet syndrome', '60 patients with sTOS randomly assigned to KT (4 men and 26 women; mean age=33.5 years, range=20-46 years) and control groups (5 men and 25 women; mean age=26 years, range=20-43 years', 'patients with sTOS', 'patients with symptomatic thoracic outlet syndrome (sTOS']","['placebo', 'kinesio taping (KT', 'placebo taping', 'kinesio taping']","['deteriorations in VAS for pain, NHP pain, NHP sleep, and NHP physical abilities', 'disabilities of the arm, shoulder, and hand (DASH) questionnaire', 'upper limb function', 'VAS for paresthesia and NHP emotional reaction', 'Pain and paresthesia', 'overall health status', 'VAS pain, VAS paresthesia, DASH, and three NHP domains (energy level, pain, and physical abilities', 'except NHP emotional reaction and NHP social isolation, median changes', 'pain, paresthesia, functional status, and overall health status', 'visual analogue scale (VAS) pain (10 cm) and VAS paresthesia', 'upper limb function and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039984', 'cui_str': 'Thoracic outlet syndrome'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451339', 'cui_str': 'Nottingham health profile'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0221736', 'cui_str': 'Reaction emotional'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0325014,"In the KT group, except the social isolation domain of the NHP, all outcome measures showed improvement from t0 to t1.","[{'ForeName': 'Emine Aygül', 'Initials': 'EA', 'LastName': 'Ortaç', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Çukurova University, School of Medicine, Adana, Turkey.'}, {'ForeName': 'Tunay', 'Initials': 'T', 'LastName': 'Sarpel', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Çukurova University, School of Medicine, Adana, Turkey.'}, {'ForeName': 'İlke', 'Initials': 'İ', 'LastName': 'Coşkun Benlidayı', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Çukurova University, School of Medicine, Adana, Turkey.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.19042']
3286,32442139,Yoga and Aerobic Dance for Pain Management in Juvenile Idiopathic Arthritis: Protocol for a Pilot Randomized Controlled Trial.,"BACKGROUND


Juvenile idiopathic arthritis (JIA) is one of the most common types of arthritis among children . According to JIA guidelines for physical activity (PA), structured PA interventions led to improved health outcomes. However, many PA programs, such as yoga and aerobic dance, have not been studied in this population despite being popular among youth. Web-based PA programs could provide patients with accessible and affordable interventions.
OBJECTIVE


The primary objectives of the proposed pilot randomized controlled trial (RCT) are to examine (1) the feasibility of conducting a full-scale RCT to evaluate the effectiveness of two popular types of PA, a yoga training program and an aerobic dance training program, in female adolescents (aged 13-18 years) with JIA compared with an electronic pamphlet control group and (2) the acceptability of these interventions.
METHODS


A three-arm prospective randomized open-label study with a parallel group design will be used. A total of 25 female adolescents with JIA who have pain will be randomized in a ratio of 2:2:1 to one of the 3 groups: (1) online yoga training program (group A; n=10), (2) online aerobic dance training program (group B; n=10), and (3) electronic pamphlet control group (group C; n=5). Participants in groups A and B will complete 3 individual 1-hour sessions per week using online exercise videos, as well as a 1-hour virtual group session per week using a video-conferencing platform for 12 weeks. Participants from all groups will have access to an electronic educational pamphlet on PA for arthritis developed by the Arthritis Society. All participants will also take part in weekly online consultations with a research coordinator and discussions on Facebook with participants from their own group. Feasibility (ie, recruitment rate, self-reported adherence to the interventions, dropout rates, and percentage of missing data), acceptability, and usability of Facebook and the video-conferencing platform will be assessed at the end of the program. Pain intensity, participation in general PA, morning stiffness, functional status, fatigue, self-efficacy, patient global assessment, disease activity, and adverse events will be assessed using self-administered electronic surveys at baseline, weekly, until the end of the 12-week program.
RESULTS


This pilot RCT has been funded by the Arthritis Health Professions Association. This protocol was approved by the Children's Hospital of Eastern Ontario Research Ethics Board (#17/08X). As of May 11, 2020, recruitment and data collection have not started.
CONCLUSIONS


To our knowledge, this is the first study to evaluate the effectiveness of yoga and aerobic dance as pain management interventions for female adolescents with JIA. The use of online programs to disseminate these 2 PA interventions may facilitate access to alternative methods of pain management. This study can lead to a full-scale RCT.
CLINICALTRIAL


ClinicalTrials.gov NCT03833609; https://clinicaltrials.gov/ct2/show/NCT03833609.",2020,"Pain intensity, participation in general PA, morning stiffness, functional status, fatigue, self-efficacy, patient global assessment, disease activity, and adverse events will be assessed using self-administered electronic surveys at baseline, weekly, until the end of the 12-week program.
","['Juvenile Idiopathic Arthritis', '25 female adolescents with JIA who have pain', 'female adolescents with JIA', 'female adolescents (aged 13-18 years) with JIA compared with an']","['yoga and aerobic dance', 'electronic pamphlet control group', 'online yoga training program', 'electronic educational pamphlet', 'electronic pamphlet control', 'yoga training program and an aerobic dance training program', 'online aerobic dance training program', 'Yoga and Aerobic Dance']","['Feasibility (ie, recruitment rate', 'dropout rates, and percentage of missing data), acceptability, and usability of Facebook and the video-conferencing platform', 'Pain intensity, participation in general PA, morning stiffness, functional status, fatigue, self-efficacy, patient global assessment, disease activity, and adverse events', 'health outcomes']","[{'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0457086', 'cui_str': 'Morning stiffness - joint'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",25.0,0.0845735,"Pain intensity, participation in general PA, morning stiffness, functional status, fatigue, self-efficacy, patient global assessment, disease activity, and adverse events will be assessed using self-administered electronic surveys at baseline, weekly, until the end of the 12-week program.
","[{'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Toupin April', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, 401 Smyth RoadL1147, Ottawa, CA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stinson', 'Affiliation': 'Child Health Evaluative Sciences, The Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, Toronto, CA.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Cavallo', 'Affiliation': 'École de Réadaptation, Université de Montréal, Montréal, CA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Proulx', 'Affiliation': 'Canadian Arthritis Patient Alliance, Ottawa, CA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Wells', 'Affiliation': 'School of Epidemiology and Public Health, Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, CA.'}, {'ForeName': 'Ciarán M', 'Initials': 'CM', 'LastName': 'Duffy', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ottawa, CA.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'ElHindi', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, CA.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Longmuir', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, CA.""}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Brosseau', 'Affiliation': 'Faculty of Health Sciences, School of Rehabilitation Sciences, University of Ottawa, Ottawa, CA.'}]",JMIR research protocols,['10.2196/12823']
3287,32442141,Computer-Based Stratified Primary Care for Musculoskeletal Consultations Compared With Usual Care: Study Protocol for the STarT MSK Cluster Randomized Controlled Trial.,"BACKGROUND


Musculoskeletal (MSK) pain is a major cause of pain and disability. We previously developed a prognostic tool (STarT Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision-making using matched treatments. A logical next step is to determine whether prognostic stratified care has benefits for a broader range of common MSK pain presentations.
OBJECTIVE


This study seeks to determine, in patients with 1 of the 5 most common MSK presentations (back, neck, knee, shoulder, and multisite pain), whether stratified care involving the use of the Keele STarT MSK Tool to allocate individuals into low-, medium-, and high-risk subgroups, and matching these subgroups to recommended matched clinical management options, is clinical and cost effective compared with usual nonstratified primary care.
METHODS


This is a pragmatic, two-arm parallel (stratified vs nonstratified care), cluster randomized controlled trial, with a health economic analysis and mixed methods process evaluation. The setting is UK primary care, involving 24 average-sized general practices randomized (stratified by practice size) in a 1:1 ratio (12 per arm) with blinding of trial statistician and outcome data collectors. Randomization units are general practices, and units of observation are adult MSK consulters without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records are tagged and individuals invited using a general practitioner (GP) point-of-consultation electronic medical record (EMR) template. The intervention is supported by an EMR template (computer-based) housing the Keele STarT MSK Tool (to stratify into prognostic subgroups) and the recommended matched treatment options. The primary outcome using intention-to-treat analysis is pain intensity, measured monthly over 6 months. Secondary outcomes include physical function and quality of life, and an anonymized EMR audit to capture clinician decision making. The economic evaluation is focused on the estimation of incremental quality-adjusted life years and MSK pain-related health care costs. The process evaluation is exploring a range of potential factors influencing the intervention and understanding how it is perceived by patients and clinicians, with quantitative analyses focusing on a priori hypothesized intervention targets and qualitative approaches using focus groups and interviews. The target sample size is 1200 patients from 24 general practices, with >5000 MSK consultations available for anonymized medical record data comparisons.
RESULTS


Trial recruitment commenced on May 18, 2018, and ended on July 15, 2019, after a 14-month recruitment period in 24 GP practices. Follow-up and interview data collection was completed in February 2020.
CONCLUSIONS


This trial is the first attempt, as far as we know, at testing a prognostic stratified care approach for primary care patients with MSK pain. The results of this trial should be available by the summer of 2020.
CLINICALTRIAL


International Standard Randomized Controlled Trial Number (ISRCTN): 15366334; http://www.isrctn.com/ISRCTN15366334.",2020,We previously developed a prognostic tool (STarT Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision-making using matched treatments.,"['primary care patients with MSK pain', '1200 patients from 24 general practices, with >5000 MSK consultations available for anonymized medical record data comparisons', 'Potential participant records are tagged and individuals invited using a general practitioner (GP) point-of-consultation electronic medical record (EMR) template', 'patients with 1 of the 5 most common MSK presentations (back, neck, knee, shoulder, and multisite pain']","['Computer-Based Stratified Primary Care for Musculoskeletal Consultations Compared With Usual Care', 'EMR template (computer-based) housing']","['intention-to-treat analysis is pain intensity', 'physical function and quality of life, and an anonymized EMR audit to capture clinician decision making']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0037293', 'cui_str': 'Skin tag'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0020056', 'cui_str': 'Housed'}]","[{'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",,0.143061,We previously developed a prognostic tool (STarT Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision-making using matched treatments.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, David Weatherall BuildingKeele University, Stoke-on-Trent, GB.'}, {'ForeName': 'Stefannie', 'Initials': 'S', 'LastName': 'Garvin', 'Affiliation': 'Keele Clinical Trials Unit, Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, GB.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, David Weatherall BuildingKeele University, Stoke-on-Trent, GB.'}, {'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Cooper', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, David Weatherall BuildingKeele University, Stoke-on-Trent, GB.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Wathall', 'Affiliation': 'Keele Clinical Trials Unit, Institute for Primary, Community and Social Care, Keele University, Stoke-on-Trent, GB.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Bartlam', 'Affiliation': 'Nanyang Technological University, Singapore, SG.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, David Weatherall BuildingKeele University, Stoke-on-Trent, GB.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, David Weatherall BuildingKeele University, Stoke-on-Trent, GB.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Protheroe', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, David Weatherall BuildingKeele University, Stoke-on-Trent, GB.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chudyk', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, David Weatherall BuildingKeele University, Stoke-on-Trent, GB.'}, {'ForeName': 'Hollie', 'Initials': 'H', 'LastName': 'Birkinshaw', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, David Weatherall BuildingKeele University, Stoke-on-Trent, GB.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Dunn', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, David Weatherall BuildingKeele University, Stoke-on-Trent, GB.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, GB.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Oppong', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, GB.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Hay', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, David Weatherall BuildingKeele University, Stoke-on-Trent, GB.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'van der Windt', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, David Weatherall BuildingKeele University, Stoke-on-Trent, GB.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mallen', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, David Weatherall BuildingKeele University, Stoke-on-Trent, GB.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Institute for Primary, Community and Social Care, Keele University, David Weatherall BuildingKeele University, Stoke-on-Trent, GB.'}]",JMIR research protocols,['10.2196/17939']
3288,32442142,Guided Internet-Based Cognitive Behavioral Therapy in Japanese Patients with Obsessive-Compulsive Disorder: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Cognitive behavioral therapy for obsessive-compulsive disorder has been established, but access to this therapy in Japan is limited. Internet-based cognitive behavioral therapy may improve treatment accessibility and sufficiently improve obsessive-compulsive symptoms. There are few randomized controlled trials examining the effectiveness of internet-based cognitive behavioral therapy in patients with obsessive-compulsive disorder. We designed a randomized controlled trial protocol to assess the effectiveness of guided internet-based cognitive behavioral therapy in Japanese patients with obsessive-compulsive disorder.
OBJECTIVE


We aimed to develop a protocol for a randomized controlled trial of internet-based cognitive behavioral therapy in Japanese patients with obsessive-compulsive disorder.
METHODS


The randomized controlled trial will compare internet-based cognitive behavioral therapy treatment and usual care groups, each consisting of 15 participants (n=30) diagnosed with obsessive-compulsive disorder. We will evaluate the effectiveness of a 12-week intervention. The primary outcome of symptom severity will be measured using the Yale-Brown Obsessive-Compulsive Scale. Secondary outcomes will be assessed with the Obsessive-Compulsive Inventory, Beck Anxiety Inventory, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Working Alliance Inventory-Short Form, and the Euro Qol - 5 Dimension. All measures will be assessed at weeks 0 (baseline) and 12 (follow-up). In the statistical analysis comparing treatment effects, the least-squares means and their 95% CIs will be estimated by analysis of covariance with the change in total outcomes scores at week 12. All comparisons are planned, and all P values will be two-sided, with values <.05 considered statistically significant.
RESULTS


The study will be performed from January 2020 to March 2021, and results are expected to be available in mid-2021.
CONCLUSIONS


The trial will demonstrate whether internet-based cognitive behavioral therapy improves access and is more effective than more usual care for patients with obsessive-compulsive disorder in Japan.
CLINICALTRIAL


University Hospital Medical Information Network (UMIN) 000039375; https://upload.umin.ac.jp/ cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044422.
INTERNATIONAL REGISTERED REPORT


DERR1-10.2196/18216.",2020,"The trial will demonstrate whether internet-based cognitive behavioral therapy improves access and is more effective than more usual care for patients with obsessive-compulsive disorder in Japan.
","['Japanese Patients with Obsessive-Compulsive Disorder', 'Japanese patients with obsessive-compulsive disorder', 'patients with obsessive-compulsive disorder in Japan', 'patients with obsessive-compulsive disorder', '15 participants (n=30) diagnosed with obsessive-compulsive disorder']","['internet-based cognitive behavioral therapy', 'guided internet-based cognitive behavioral therapy', 'Cognitive behavioral therapy', 'Internet-based cognitive behavioral therapy', 'Guided Internet-Based Cognitive Behavioral Therapy']","['symptom severity will be measured using the Yale-Brown Obsessive-Compulsive Scale', 'Obsessive-Compulsive Inventory, Beck Anxiety Inventory, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Working Alliance Inventory-Short Form, and the Euro Qol - 5 Dimension', 'obsessive-compulsive symptoms']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472214', 'cui_str': 'Obsessive compulsive inventory'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}]",,0.1134,"The trial will demonstrate whether internet-based cognitive behavioral therapy improves access and is more effective than more usual care for patients with obsessive-compulsive disorder in Japan.
","[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Research Center for Child Mental Development, Chiba University, Chiba, JP.'}, {'ForeName': 'Sayo', 'Initials': 'S', 'LastName': 'Hamatani', 'Affiliation': 'Research Center for Child Mental Development, Chiba University, Chiba, JP.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Makino', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Fukui, JP.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Uemura', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Fukui, JP.'}, {'ForeName': 'Futoshi', 'Initials': 'F', 'LastName': 'Suzuki', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Fukui, JP.'}, {'ForeName': 'Seina', 'Initials': 'S', 'LastName': 'Shinno', 'Affiliation': 'Department of Integrated Medical Sciences, Graduate School of Medicine, University of Fukui, Fukui, JP.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Ikai', 'Affiliation': 'Department of Primary Health Care, Faculty of Medicine, University of Fukui, Fukui, JP.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Department of Integrated Advanced Medicine, Graduate School of Medicine, University of Fukui, Fukui, JP.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Sutoh', 'Affiliation': 'Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Chiba University, Chiba, JP.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Shimizu', 'Affiliation': 'Research Center for Child Mental Development, Chiba University, Chiba, JP.'}]",JMIR research protocols,['10.2196/18216']
3289,32442746,The effect of mirror therapy after carpal tunnel syndrome surgery: a randomized controlled study.,"The aim of this randomized controlled study was to investigate the effectiveness of mirror therapy (MT) on carpal tunnel syndrome (CTS) patients' symptoms and hand function after surgery. The patients' hand function was evaluated using the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Nine Hole Peg Test. Their pain was evaluated using a visual analog scale, and their sensitivity was evaluated using the Semmes-Weinstein monofilament test before surgery, and at 3 and 6 weeks post-surgery. Thirty-five patients between the ages of 25 and 60 years were included in the study. In the control group (CTG) (n=17), the conventional physiotherapy program was applied for 4 weeks after 2 weeks of immobilization. In addition to conventional physiotherapy, the MT group (MTG) (n=18) did MT during the immobilization period. There were no statistically significant differences between the groups' demographic and clinical characteristics before treatment (p˃0.05). After treatment, all parameters improved in both groups. MTG had statistically lower pain at rest (p=0.004) and nighttime pain (p=0.037) in the 3 rd  week. But there were no statistically significant differences between the other parameters and scores between the groups (p˃0.05). The study indicates improvement in the parameters due to the early introduction of MT after CTS surgery, but once conventional methods were started after immobilization, there were no significant differences between groups. However, the MT had reduced pain and improved sensation and function. Both groups experienced positive effects of the surgical treatment and the physiotherapy in the 6 th  postoperative week.",2020,MTG had statistically lower pain at rest (p=0.004) and nighttime pain (p=0.037) in the 3 rd  week.,"[""carpal tunnel syndrome (CTS) patients' symptoms and hand function after surgery"", 'Thirty-five patients between the ages of 25 and 60 years were included in the study', 'carpal tunnel syndrome surgery']","['conventional physiotherapy program', 'mirror therapy (MT', 'mirror therapy', 'conventional physiotherapy, the MT group (MTG']","['pain and improved sensation and function', 'nighttime pain', 'Boston Carpal Tunnel Syndrome Questionnaire (BCTQ', 'pain']","[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",35.0,0.0252547,MTG had statistically lower pain at rest (p=0.004) and nighttime pain (p=0.037) in the 3 rd  week.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Civi Karaaslan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Division of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpasa, Büyükçekmece Yerleşkesi Alkent 2000 Mh. Yiğittürk Cd. No:5/9/1, 34500, İstanbul, Turkey. Electronic address: tugba.civi@istanbul.edu.tr.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Berkoz', 'Affiliation': 'Hand Surgery Unit, Department of Plastic, Reconstructive and Aesthetic Surgery, Topkapı, Turgut Özal Millet Cd, 34093, Fatih, İstanbul, Turkey.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tarakci', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Division of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpasa, Büyükçekmece Yerleşkesi Alkent 2000 Mh. Yiğittürk Cd. No:5/9/1, 34500, İstanbul, Turkey.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2020.04.011']
3290,32442781,The impact of exposure therapy on stigma and mental health treatment attitudes among active duty U.S. soldiers with combat related PTSD.,"Although cognitive behavioral interventions improve attitudes toward mental health treatment and reduce stigma, little is known about which types of attitudes change, or how this change occurs. Active duty soldiers with PTSD (N = 162) were randomized to 10 sessions of exposure therapy or a waitlist. Soldiers were assessed for PTSD and completed measures of stigma and attitudes towards mental health services before randomization and after 5- and 10- sessions of therapy. At post-treatment, soldiers in exposure therapy demonstrated significant improvements in openness to talking about mental health problems and concerns about what others may think if they knew they were seeking mental health treatment, relative to those in the waitlist. There were significant indirect effects from treatment to changes in stigma and attitudes towards mental health treatment through changes in PTSD symptoms at post-treatment. There was also a significant indirect effect from treatment to changes in stigma at post-treatment through changes in attitudes towards mental health treatment at mid-treatment, suggesting attitude change may occur first. Baseline characteristics did not moderate treatment's change in stigma or attitudes. Improvements in PTSD symptoms and positive changes in attitudes towards mental health treatment appear to separately predict later reductions in stigma.",2020,"At post-treatment, soldiers in exposure therapy demonstrated significant improvements in openness to talking about mental health problems and concerns about what others may think if they knew they were seeking mental health treatment, relative to those in the waitlist.","['stigma and mental health treatment attitudes among active duty U.S. soldiers with combat related PTSD', 'Active duty soldiers with PTSD (N\xa0=\xa0162']","['exposure therapy', 'cognitive behavioral interventions', 'exposure therapy or a waitlist']","['stigma and attitudes towards mental health services', 'openness to talking about mental health problems', 'stigma or attitudes']","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C5191360', 'cui_str': '162'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0547049', 'cui_str': 'Openness'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}]",162.0,0.0278219,"At post-treatment, soldiers in exposure therapy demonstrated significant improvements in openness to talking about mental health problems and concerns about what others may think if they knew they were seeking mental health treatment, relative to those in the waitlist.","[{'ForeName': 'Greg M', 'Initials': 'GM', 'LastName': 'Reger', 'Affiliation': 'VA Puget Sound Health Care System, 9600 Veterans Drive, A-116, Tacoma, WA, 98493, United States; University of Washington School of Medicine, 1959 NE Pacific St, Box 356560, Seattle, WA, 98195-6560, United States. Electronic address: greg.reger@va.gov.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Bourassa', 'Affiliation': 'VA Puget Sound Health Care System, 9600 Veterans Drive, A-116, Tacoma, WA, 98493, United States; Duke University Medical Center, Center for Aging and Human Development, 2020 W. Main St., Durham, NC, 27707, United States.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Norr', 'Affiliation': 'VISN 20 Northwest Network Mental Illness Research, Education and Clinical Center (MIRECC), 1660 S. Columbian Way, Seattle, WA, 98108, United States; University of Washington School of Medicine, 1959 NE Pacific St, Box 356560, Seattle, WA, 98195-6560, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Buck', 'Affiliation': 'VA Puget Sound Health Care System, 9600 Veterans Drive, A-116, Tacoma, WA, 98493, United States; University of Washington School of Medicine, 1959 NE Pacific St, Box 356560, Seattle, WA, 98195-6560, United States.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.005']
3291,32442828,Subgroup analysis of the early paracetamol trial to preterm infants found haemodynamic changes and improved oxygenation.,"BACKGROUND


We previously reported in a randomised trial that early intravenous paracetamol accelerated contraction of ductus arteriosus in very preterm infants (<32 gestation weeks).
AIMS


To monitor sequentially paracetamol effects on the blood pressure and brain tissue oxygenation in the infants participating the trial.
METHODS


In a double-blind trial, intravenous paracetamol or placebo was infused to 48 very premature infants starting within 24 h of birth for four days. Besides the ductus arteriosus, we systematically measured blood pressure, peripheral (spO 2 ) and regional cerebral oxygen saturation (rcSO 2 ), and cerebral fractional tissue oxygen extraction (cFTOE) during the study period.
RESULTS


Compared to the placebo, the paracetamol loading dose transiently decreased the arterial blood pressure. During treatment, the paracetamol-treated infants had higher spO 2  (p = .042) and rcSO 2  (p = .036) values than the placebo group infants. Additionally, the cFTOE values were lower in the paracetamol group during the study without statistical significance. All infants with closed ductus had higher tissue oxygenation and a lower cFTOE than infants with open ductus.
CONCLUSIONS


Paracetamol caused modest haemodynamic effects and increased cerebral oxygenation. They were mostly due to early contraction of ductus. Additional direct drug-effects in brain are not ruled-out.",2020,"During treatment, the paracetamol-treated infants had higher spO 2  (p = .042) and rcSO 2  (p = .036) values than the placebo group infants.","['very preterm infants (<32 gestation weeks', '48 very premature infants starting within 24\u202fh of birth for four days', 'infants participating the trial']","['paracetamol', 'intravenous paracetamol or placebo', 'Paracetamol', 'placebo']","['haemodynamic effects', 'haemodynamic changes and improved oxygenation', 'tissue oxygenation', 'arterial blood pressure', 'blood pressure and brain tissue oxygenation', 'blood pressure, peripheral (spO 2 ) and regional cerebral oxygen saturation (rcSO 2 ), and cerebral fractional tissue oxygen extraction (cFTOE', 'cerebral oxygenation']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0440746', 'cui_str': 'Brain tissue'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]",48.0,0.459725,"During treatment, the paracetamol-treated infants had higher spO 2  (p = .042) and rcSO 2  (p = .036) values than the placebo group infants.","[{'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Härmä', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Aikio', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland. Electronic address: outi.aikio@ppshp.fi.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Härkin', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Leskinen', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Valkama', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Saarela', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}]",Early human development,['10.1016/j.earlhumdev.2020.105042']
3292,32442971,Thick and diffuse cisternal clot independently predicts vasospasm-related morbidity and poor outcome after aneurysmal subarachnoid hemorrhage.,"OBJECTIVE


Aneurysmal subarachnoid hemorrhage (aSAH) is associated with significant morbidity and mortality. The presence of thick, diffuse subarachnoid blood may portend a worse clinical course and outcome, independently of other known prognostic factors such as age, aneurysm size, and initial clinical grade.
METHODS


In this post hoc analysis, patients with aSAH undergoing surgical clipping (n = 383) or endovascular coiling (n = 189) were pooled from the placebo arms of the Clazosentan to Overcome Neurological Ischemia and Infarction Occurring After Subarachnoid Hemorrhage (CONSCIOUS)-2 and CONSCIOUS-3 randomized, double-blind, placebo-controlled phase 3 studies, respectively. Patients without and with thick, diffuse SAH (≥ 4 mm thick and involving ≥ 3 basal cisterns) on admission CT scans were compared. Clot size was centrally adjudicated. All-cause mortality and vasospasm-related morbidity at 6 weeks and Glasgow Outcome Scale-Extended (GOSE) scores at 12 weeks after aSAH were assessed. The effect of the thick and diffuse cisternal aSAH on vasospasm-related morbidity and mortality, and on poor clinical outcome at 12 weeks, was evaluated using logistic regression models.
RESULTS


Overall, 294 patients (51.4%) had thick and diffuse aSAH. Compared to patients with less hemorrhage burden, these patients were older (median age 55 vs 50 years) and more often had World Federation of Neurosurgical Societies (WFNS) grade III-V SAH at admission (24.1% vs 16.5%). At 6 weeks, all-cause mortality and vasospasm-related morbidity occurred in 36.1% (95% CI 30.6%-41.8%) of patients with thick, diffuse SAH and in 14.7% (95% CI 10.8%-19.5%) of those without thick, diffuse SAH. Individual event rates were 7.5% versus 2.5% for all-cause death, 19.4% versus 6.8% for new cerebral infarct, 28.2% versus 9.4% for delayed ischemic neurological deficit, and 24.8% versus 10.8% for rescue therapy due to cerebral vasospasm, respectively. Poor clinical outcome (GOSE score ≥ 4) was observed in 32.7% (95% CI 27.3%-38.3%) and 16.2% (95% CI 12.1%-21.1%) of patients with and without thick, diffuse SAH, respectively.
CONCLUSIONS


In a large, centrally adjudicated population of patients with aSAH, WFNS grade at admission and thick, diffuse SAH independently predicted vasospasm-related morbidity and poor 12-week clinical outcome. Patients with thick, diffuse cisternal SAH may be an important cohort to target in future clinical trials of treatment for vasospasm.",2020,All-cause mortality and vasospasm-related morbidity at 6 weeks and Glasgow Outcome Scale-Extended (GOSE) scores at 12 weeks after aSAH were assessed.,"['After Subarachnoid Hemorrhage', 'Patients with thick, diffuse cisternal', 'patients with aSAH undergoing surgical clipping (n = 383) or', '294 patients (51.4%) had thick and diffuse aSAH']","['Clazosentan', 'endovascular coiling', 'placebo']","['Clot size', 'Individual event rates', 'World Federation of Neurosurgical Societies (WFNS) grade III-V SAH at admission', 'Neurological Ischemia and Infarction Occurring', 'All-cause mortality and vasospasm-related morbidity at 6 weeks and Glasgow Outcome Scale-Extended (GOSE) scores', 'mortality and vasospasm-related morbidity', 'delayed ischemic neurological deficit', 'admission CT scans']","[{'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C1721268', 'cui_str': 'clazosentan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0036001', 'cui_str': 'S-Adenosyl homocysteine'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4285772', 'cui_str': 'Delayed ischaemic neurological deficit'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",189.0,0.207046,All-cause mortality and vasospasm-related morbidity at 6 weeks and Glasgow Outcome Scale-Extended (GOSE) scores at 12 weeks after aSAH were assessed.,"[{'ForeName': 'E François', 'Initials': 'EF', 'LastName': 'Aldrich', 'Affiliation': '1Department of Neurosurgery, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Higashida', 'Affiliation': '2Department of Neurointerventional Radiology, University of California San Francisco Medical Center, San Francisco, California.'}, {'ForeName': 'Abdel', 'Initials': 'A', 'LastName': 'Hmissi', 'Affiliation': '3Global Clinical Development, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Le', 'Affiliation': '1Department of Neurosurgery, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'R Loch', 'Initials': 'RL', 'LastName': 'Macdonald', 'Affiliation': '4Department of Neurological Surgery, University of California San Francisco, Fresno, California.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Marr', 'Affiliation': '3Global Clinical Development, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Mayer', 'Affiliation': '6Department of Neurology, Henry Ford Neuroscience Institute, Wayne State School of Medicine, Detroit, Michigan; and.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Roux', 'Affiliation': '3Global Clinical Development, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bruder', 'Affiliation': '7Department of Anesthesia and Critical Care, Hôpital de la Timone, Aix-Marseille Université, Marseille, France.'}]",Journal of neurosurgery,['10.3171/2020.3.JNS193400']
3293,32443695,The Effects of  Aronia melanocarpa  Juice Consumption on the mRNA Expression Profile in Peripheral Blood Mononuclear Cells in Subjects at Cardiovascular Risk.,"Foods and food products that contain polyphenols are proposed to modulate risk of cardiovascular disease. The aim of this three-arm, crossover, randomized, double-blind, placebo-controlled intervention study was to examine the impact of  Aronia melanocarpa  juice (AMJ), high-polyphenol (AMJ treatment, 1.17 g/100 mL polyphenols) and low-polyphenol (dAMJ treatment, 0.29 g/100 mL polyphenols) dose, on the transcriptome in peripheral blood mononuclear cells (PBMC) of 19 subjects at cardiovascular risk. Transcriptome data were obtained by microarray. Bioinformatic functional annotation analysis was performed on both the whole transcriptome datasets and the differentially expressed genes (DEGs). Expression of selected DEGs was validated by RT-qPCR. Administration of AMJ and dAMJ treatments during the two consecutive four-week treatment periods had additive effects on PBMC transcriptome profiles, with the most pronounced and specific effect noticed for AMJ in the last treatment period (TP3) of the trial. Between the high-dose and low-dose treatments in TP3, there was a multitude of overlapping DEGs and DEG-enriched biological processes and pathways, which primarily included immunomodulation and regulation of cell proliferation/death. Increased expression of  TNF ,  IL1B ,  IL8 ,  RGS1 ,  OSM , and  DUSP2  in TP3 was confirmed by RT-qPCR. The results suggest the immunomodulatory effects of prolonged habitual consumption of polyphenol-rich aronia juice in individuals at cardiovascular risk.",2020,"Increased expression of  TNF ,  IL1B ,  IL8 ,  RGS1 ,  OSM , and  DUSP2  in TP3 was confirmed by RT-qPCR.","['individuals at cardiovascular risk', '19 subjects at cardiovascular risk', 'Subjects at Cardiovascular Risk']","['Aronia melanocarpa  juice (AMJ), high-polyphenol (AMJ treatment, 1.17 g/100 mL polyphenols) and low-polyphenol (dAMJ treatment, 0.29 g/100 mL polyphenols', 'AMJ and dAMJ', 'polyphenol-rich aronia juice', 'Aronia melanocarpa  Juice Consumption', 'placebo']","['peripheral blood mononuclear cells (PBMC', 'Increased expression of  TNF ,  IL1B ,  IL8 ,  RGS1 ,  OSM , and  DUSP2  in TP3', 'Peripheral Blood Mononuclear Cells']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C1449661', 'cui_str': 'Aronia melanocarpa'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517494', 'cui_str': '1.17'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4517446', 'cui_str': '0.29'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1215581', 'cui_str': 'Aronia'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1448758', 'cui_str': 'RGS1 protein, human'}, {'cui': 'C0439186', 'cui_str': 'osmol'}, {'cui': 'C0075032', 'cui_str': 'splenotritin'}]",19.0,0.0972833,"Increased expression of  TNF ,  IL1B ,  IL8 ,  RGS1 ,  OSM , and  DUSP2  in TP3 was confirmed by RT-qPCR.","[{'ForeName': 'Ljiljana', 'Initials': 'L', 'LastName': 'Stojković', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Jovanović', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Zivković', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'Zec', 'Affiliation': 'Centre of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Djurić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Zivotić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Jovana', 'Initials': 'J', 'LastName': 'Kuveljić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Kolaković', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Kolić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Djordjević', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Glibetić', 'Affiliation': 'Centre of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Alavantić', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Stanković', 'Affiliation': 'Laboratory for Radiobiology and Molecular Genetics, ""Vinča"" Institute of Nuclear Sciences, University of Belgrade, 11000 Belgrade, Serbia.'}]",Nutrients,['10.3390/nu12051484']
3294,32443744,Effectiveness of A Pilates Training Program on Cognitive and Functional Abilities in Postmenopausal Women.,"The purpose of this study was to determine the effects of a Pilates exercises program on the cognitive and physical functioning of older Spanish women. This study is a randomized clinical trial; a total of 110 women aged ≥60 years were initially allocated to either a Pilates group (PG, n = 55), who underwent a 12-week Pilates exercise program, or to a control group (CG, n = 55), who did not receive any intervention. Global cognitive function (Mini-Mental State Examination), verbal fluency (Isaacs test), executive function (Trail Making Test), functional flexibility (Back Scratch Test and Chair Sit-and-Reach Test), and lower-body strength (30 s Chair-Stand Test) were assessed before and immediately after the intervention period. The main findings of this study suggest that women in the PG (within-group differences) experienced improvements across all the variables examined except for global cognitive function. When compared with the CG (between-group differences), our analysis revealed significant benefits in the PG for all measures except for global cognitive function and functional flexibility (Back Scratch Test). In conclusion, our results suggest that Pilates has the potential to improve both cognitive and functional abilities among Spanish women aged 60 years and over.",2020,"When compared with the CG (between-group differences), our analysis revealed significant benefits in the PG for all measures except for global cognitive function and functional flexibility (Back Scratch Test).","['Spanish women aged 60 years and over', 'Postmenopausal Women', '110 women aged ≥60 years', 'older Spanish women']","['Pilates Training Program', 'Pilates exercises program', 'Pilates exercise program, or to a control group (CG, n = 55), who did not receive any intervention']","['cognitive and functional abilities', 'global cognitive function and functional flexibility (Back Scratch Test', 'global cognitive function', 'Global cognitive function (Mini-Mental State Examination), verbal fluency (Isaacs test), executive function (Trail Making Test), functional flexibility (Back Scratch Test and Chair Sit-and-Reach Test), and lower-body strength (30 s Chair-Stand Test', 'Cognitive and Functional Abilities', 'cognitive and physical functioning']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1321049', 'cui_str': 'Pilates exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0430562', 'cui_str': 'Scratch test'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",110.0,0.0263371,"When compared with the CG (between-group differences), our analysis revealed significant benefits in the PG for all measures except for global cognitive function and functional flexibility (Back Scratch Test).","[{'ForeName': 'Patricia Alexandra', 'Initials': 'PA', 'LastName': 'García-Garro', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Fidel', 'Initials': 'F', 'LastName': 'Hita-Contreras', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Martínez-Amat', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Achalandabaso-Ochoa', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'José Daniel', 'Initials': 'JD', 'LastName': 'Jiménez-García', 'Affiliation': 'Department of Teaching Physical Education, Fine Arts and Music, University of Cádiz, 11003 Cádiz, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cruz-Díaz', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Aibar-Almazán', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17103580']
3295,32443843,Effect of Exclusive Primer and Adhesive on Microtensile Bond Strength of Self-Adhesive Resin Cement to Dentin.,"The aim of this study was to investigate the effect of G-CEM One Primer (GCOP) and self-etching adhesive on the microtensile bond strength (µTBS) between self-adhesive resin cement G-CEM One (GCO) and dentin. Teeth were sectioned to expose the flat dentin surface and randomly assigned into five groups (n = 15) according to the dentin surface treatment: 1) no surface treatment, 2) GCOP, 3) All-Bond Universal (ABU), 4) GCOP followed by ABU (GCOP/ABU), 5) ABU followed by GCOP (ABU/GCOP). The composite resin blocks were bonded to the dentin surface using GCO. The specimens were stored in distilled water at 37 °C for 24 h, then sectioned into sticks (1 mm × 10 mm). The μTBS values were statistically analyzed using 1-way analysis of variance (ANOVA) and Tukey's honestly significant difference (HSD) test ( α  = 0.05) and failure mode was examined under a stereomicroscope. The bonding interface of each specimen was evaluated using confocal laser scanning microscopy. The GCOP group exhibited the highest µTBS value and there were no significant differences observed between GCOP, GCOP/ABU, ABU/GCOP groups ( p  > 0.05). The use of GCOP with GCO results in the improved µTBS between GCO and dentin. In conclusion, using only GCOP with GCO for bonding of indirect restoration is extremely simple and increasing bond strength.",2020,"The GCOP group exhibited the highest µTBS value and there were no significant differences observed between GCOP, GCOP/ABU, ABU/GCOP groups ( p  > 0.05).",['Self-Adhesive Resin Cement to Dentin'],"['dentin surface treatment: 1) no surface treatment, 2) GCOP, 3) All-Bond Universal (ABU), 4) GCOP followed by ABU (GCOP/ABU), 5) ABU followed by GCOP (ABU/GCOP', 'GCOP', 'G-CEM']","['μTBS values', 'highest µTBS value', 'microtensile bond strength (µTBS']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0376523', 'cui_str': 'Resin Cement'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0045845', 'cui_str': '2-amino-4-phosphonobutyric acid'}, {'cui': 'C0378574', 'cui_str': '2-chloroethyl methyl sulfide'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",,0.0204166,"The GCOP group exhibited the highest µTBS value and there were no significant differences observed between GCOP, GCOP/ABU, ABU/GCOP groups ( p  > 0.05).","[{'ForeName': 'Bit-Na', 'Initials': 'BN', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Pusan National University, Dental Research Institute, Yangsan 50612, Korea.'}, {'ForeName': 'Sung-Ae', 'Initials': 'SA', 'LastName': 'Son', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Pusan National University, Dental Research Institute, Yangsan 50612, Korea.'}, {'ForeName': 'Jeong-Kil', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Pusan National University, Dental Research Institute, Yangsan 50612, Korea.'}]","Materials (Basel, Switzerland)",['10.3390/ma13102353']
3296,32443950,Intervention Design and Trial Protocol: Mindfulness-based Exposure for PAP-associated Claustrophobia.,"Positive airway pressure (PAP) associated claustrophobia is common among obstructive sleep apnea patients and plays a prominent role in low adherence and treatment failure. As there are no evidence-based interventions for PAP-associated claustrophobia, the objective of the present research is to pilot test Mindfulness-based Exposure for PAP-associated Claustrophobia, in sleep apnea adults that present with treatment non-adherence and claustrophobia. This approach combines Mindfulness-based Stress Reduction with exposure-based treatment components to target this treatment-associated claustrophobia. The present article outlines the mindfulness exposure intervention design and methods and reports the pilot trial study protocol. Trial findings are intended to: (a) develop a preliminary effect size of the intervention on PAP-associated claustrophobia; (b) explore differences in treatment adherence by group (intervention vs control); and (c) establish feasibility for expanded protocol implementation, delivery, and participant acceptability of the intervention to support subsequent design of a fully powered randomized controlled trial.",2020,associated claustrophobia is common among obstructive sleep apnea patients and plays a prominent role in low adherence and treatment failure.,"['sleep apnea adults', 'obstructive sleep apnea patients']",[],['Positive airway pressure (PAP'],"[{'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]",,0.0245856,associated claustrophobia is common among obstructive sleep apnea patients and plays a prominent role in low adherence and treatment failure.,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Gawrysiak', 'Affiliation': 'Department of Psychology, West Chester University of Pennsylvania, West Chester, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baime', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Tonya S', 'Initials': 'TS', 'LastName': 'King', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Alexa J', 'Initials': 'AJ', 'LastName': 'Watach', 'Affiliation': 'Center for Sleep and Circadian Neurobiology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Miranda V', 'Initials': 'MV', 'LastName': 'McPhillips', 'Affiliation': 'Center for Sleep and Circadian Neurobiology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Kolanowski', 'Affiliation': 'College of Nursing, Penn State University, University Park, PA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Schutte-Rodin', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Sawyer', 'Affiliation': 'Center for Sleep and Circadian Neurobiology, University of Pennsylvania, Philadelphia, PA, USA.'}]",Western journal of nursing research,['10.1177/0193945920924608']
3297,32443961,Primary Care Clinic Nurse Activities with a Telehealth Monitoring System.,"The purpose of this study was to evaluate differences in the types of nursing activities and communication processes reported in a primary care clinic between patients who used a home-based monitoring system to electronically communicate self-monitored blood glucose and blood pressure values and those who assumed usual care. Data were extracted from electronic medical records from individuals who participated in a randomized controlled trial comparing in-home monitoring and usual care in patients with Type 2 diabetes and hypertension being treated in a primary care clinic. Data about nursing activities initiated by primary care clinic nurses were compared between groups using descriptive statistics and independent  t -tests. Significant differences between groups were identified for the direct care nursing activities of providing lifestyle and health education, medication adjustments, and patient follow-up. This study provides evidence of greater nursing activity reported in a primary care clinic in patients who utilized a home-based monitoring system.",2020,"Significant differences between groups were identified for the direct care nursing activities of providing lifestyle and health education, medication adjustments, and patient follow-up.","['patients with Type 2 diabetes and hypertension being treated in a primary care clinic', 'patients who utilized a home-based monitoring system', 'patients who used a home-based monitoring system to electronically communicate self-monitored blood glucose and blood pressure values and those who assumed usual care']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",[],[],,0.0129672,"Significant differences between groups were identified for the direct care nursing activities of providing lifestyle and health education, medication adjustments, and patient follow-up.","[{'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Howland', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Despins', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Jeri', 'Initials': 'J', 'LastName': 'Sindt', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Wakefield', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Mehr', 'Affiliation': 'Curtis W. and Ann H. Long Department of Family and Community Medicine, School of Medicine, University of Missouri, Columbia, MO, USA.'}]",Western journal of nursing research,['10.1177/0193945920923082']
3298,32444152,Land-walking vs. water-walking interventions in older adults: Effects on aerobic fitness.,"BACKGROUND


Low cardiorespiratory fitness is an independent predictor of all-cause and cardiovascular mortality, and interventions that increase fitness reduce risk. Water-walking decreases musculoskeletal impact and risk of falls in older individuals, but it is unclear whether water-walking improves aerobic fitness in the same way as weight-dependent land-walking. This randomized controlled trial involved 3 intervention groups-a no-exercise control group (CG), a land-walking (LW) group, and a water-walking (WW) group-to investigate the comparative impacts of LW and WW to CG on fitness.
METHODS


Both exercise groups attended individually tailored, center-based, intensity-matched 3 × weekly sessions for 24 weeks, which progressed to 150 min of exercise per week. This was followed by a 24-week no-intervention period. Maximal graded exercise tests were performed on a treadmill at Weeks 0, 24, and 48.
RESULTS


Maximal oxygen uptake increased from Week 0 to Week 24 in both exercise groups (0.57 ± 0.62 mL/kg/min, 0.03 ± 0.04 L/min for LW; 0.93 ± 0.75 mL/kg/min, 0.06 ± 0.06 L/min for WW, mean ± SE) compared to the CG (-1.75 ± 0.78 mL/kg/min, -0.16 ± 0.05 L/min) (group × time, p < 0.05). Time to exhaustion increased significantly following LW only (123.4 ± 25.5 s), which was significantly greater (p = 0.001) than the CG (24.3 ± 18.5 s). By Week 48, the training-induced adaptations in the exercise groups returned to near baseline levels.
CONCLUSION


Our study supports current physical-activity recommendations that 150 min/week of moderate-intensity exercise produces improvements in fitness in previously sedentary older individuals. Also, LW and WW elicit similar improvements in fitness if conducted at the same relative intensities. Exercise-naïve older individuals can benefit from the lower impact forces and decreased risk of falls associated with WW without compromising improvements in cardiorespiratory fitness.",2020,"Time to exhaustion increased significantly following LW only (123.4 ± 25.5 s), which was significantly greater (p = 0.001) than the CG (24.3 ± 18.5 s).","['older individuals', 'Exercise-naïve older individuals', 'previously sedentary older individuals', 'older adults']","['moderate-intensity exercise', 'no-exercise control group (CG), a land-walking (LW) group, and a water-walking (WW', 'Land-walking vs. water-walking interventions', 'Water-walking']","['aerobic fitness', 'Maximal oxygen uptake', 'Time to exhaustion']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}]",,0.0350292,"Time to exhaustion increased significantly following LW only (123.4 ± 25.5 s), which was significantly greater (p = 0.001) than the CG (24.3 ± 18.5 s).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haynes', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Carter', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Spence', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, WA 6102, Australia.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Robey', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia; School of Medicine, The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Maslen', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Lautenschlager', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, VIC 3010, Australia; North Western Mental Health, Melbourne Health, Melbourne, VIC 3010, Australia; Division of Psychiatry, WA Centre for Health & Ageing, The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Nicola D', 'Initials': 'ND', 'LastName': 'Ridgers', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3125, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia. Electronic address: danny.green@uwa.edu.au.'}]",Journal of sport and health science,['10.1016/j.jshs.2019.11.005']
3299,32444161,Using a Mobile Phone Application Versus Telephone Assistance During Cardiopulmonary Resuscitation: A Randomized Comparative Study.,"INTRODUCTION


In recent years, the way CPR instructions are given has changed because of the development of new technology that allows bystanders who witness a cardiac arrest to be guided in performing CPR. This study aimed to compare the effectiveness of using a mobile phone application (app) versus telephone operator assistance in performing cardiopulmonary resuscitation (CPR) techniques in simulated settings.
METHODS


A comparative study was performed with 2 intervention groups: (1) mobile phone app and (2) telephone assistance. A total of 128 students participated and were distributed randomly into each intervention group. A CPR observation checklist and standard CPR quality parameter measurements were used for data collection.
RESULTS


The group that used the app obtained better results than the group that had telephone assistance on 5 items during CPR observation: checking if the area is secure (X 2 (1) = 26.812; P < 0.05), asking for help (X 2 (1) = 66.074; P < 0.05), opening of airways (X 2 (1) = 12.025; P < 0.05), checking for breathing (X 2 (1) = 6.104; P < 0.05), and contacting emergency services (X 2 (1) = 12.405; P < 0.05). Regarding the skill level of CPR, no statistically significant differences were found when comparing the 2 intervention groups (X 2 (1) = 0.908; P = 0.33). As for the parameters measured, there were only statistically significant differences found in the item compression fraction (U = 1,593.000; Z = -2.161; P < 0.05), with the group that used the app obtaining better results.
DISCUSSION


Better outcomes were observed in recognizing if the area was safe, asking for help, opening up the airways, checking for breathing, and calling emergency services in the mobile phone app group. However, the results indicated that there were no differences in the CPR parameters, except compression fraction, when the app was used as opposed to being guided by telephone.",2020,"The group that used the app obtained better results than the group that had telephone assistance on 5 items during CPR observation: checking if the area is secure (X 2 (1) = 26.812; P < 0.05), asking for help (X 2 (1) =","['128 students participated', 'During Cardiopulmonary Resuscitation']","['mobile phone application (app) versus telephone operator assistance', 'Mobile Phone Application Versus Telephone Assistance', 'mobile phone app and (2) telephone assistance']","['CPR parameters, except compression fraction', 'contacting emergency services', 'item compression fraction', 'checking for breathing', 'opening of airways']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",128.0,0.0187919,"The group that used the app obtained better results than the group that had telephone assistance on 5 items during CPR observation: checking if the area is secure (X 2 (1) = 26.812; P < 0.05), asking for help (X 2 (1) =","[{'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Márquez-Hernández', 'Affiliation': ''}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Gutiérrez-Puertas', 'Affiliation': ''}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Garrido-Molina', 'Affiliation': ''}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'García-Viola', 'Affiliation': ''}, {'ForeName': 'Genoveva', 'Initials': 'G', 'LastName': 'Granados-Gámez', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Aguilera-Manrique', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2020.03.015']
3300,32444166,Effective support following recurrent pregnancy loss: a randomized controlled feasibility and acceptability study.,"RESEARCH QUESTION


Is it feasible to perform a future definitive trial to determine the effectiveness of the positive reappraisal coping intervention (PRCI) in improving the psychological well-being of women with recurrent pregnancy loss (RPL) during the early stages of a new pregnancy?
DESIGN


This mixed method study aimed to establish the feasibility of conducting a multicentre randomized controlled trial (RCT) to definitively test the effects of the PRCI on the psychological well-being of women with RPL. Participants (n = 75) were recruited to the study and at the point of a positive pregnancy test, 47 were randomized into two study groups. The intervention group received the PRCI and weekly questionnaire assessment (Hospital Anxiety and Depression Scale and Weekly Record Keeping Form [WRK]) to monitor psychological well-being; the control group received the same questionnaires. Nested within the RCT was a qualitative process evaluation (QPE) exploring participants' subjective experience of study methods and the intervention. The study was conducted over a two-year period between 2014 and 2016.
RESULTS


This study successfully gathered knowledge about the feasibility aspects of conducting a future multicentre definitive study to determine the effects of the PRCI on the psychological well-being of women with RPL. Participants were receptive to its use and the intervention appeared to convey benefits with no apparent downside.
CONCLUSIONS


The study concluded that a definitive RCT of the PRCI is possible and that the model of care already has the potential to be made more widely available as a safe, low-cost, convenient and easily deliverable intervention to provide much-needed support to a vulnerable patient population.",2020,"Participants were receptive to its use and the intervention appeared to convey benefits with no apparent downside.
","['women with recurrent pregnancy loss (RPL) during the early stages of a new pregnancy', 'Participants (n\u202f=\u202f75) were recruited to the study and at the point of a positive pregnancy test, 47 were randomized into two study groups', 'two-year period between 2014 and 2016', 'women with RPL']","['positive reappraisal coping intervention (PRCI', 'PRCI and weekly questionnaire assessment (Hospital Anxiety and Depression Scale and Weekly Record Keeping Form [WRK]) to monitor psychological well-being; the control group received the same questionnaires', 'PRCI']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0240802', 'cui_str': 'Pregnancy test positive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],75.0,0.0546913,"Participants were receptive to its use and the intervention appeared to convey benefits with no apparent downside.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': 'University Hospitals Southampton NHS Foundation Trust, Princess Anne Hospital, Coxford Road, Southampton SO16 5YA, UK; Faculty of Health Sciences, University of Southampton, University Road, Southampton SO17 1BJ, UK. Electronic address: sarahl.bailey@soton.ac.uk.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Boivin', 'Affiliation': 'School of Psychology, Cardiff University, 70 Park Place, Cardiff Wales CF10 3AT, UK.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheong', 'Affiliation': 'Faculty of Medicine, University of Southampton, University Road, Southampton SO17 1BJ, UK; Complete Fertility Centre, Princess Anne Hospital, Coxford Road, Southampton SO16 5YA, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bailey', 'Affiliation': 'Faculty of Health Sciences, University of Southampton, University Road, Southampton SO17 1BJ, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Kitson-Reynolds', 'Affiliation': 'Faculty of Health Sciences, University of Southampton, University Road, Southampton SO17 1BJ, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Macklon', 'Affiliation': 'Faculty of Medicine, University of Southampton, University Road, Southampton SO17 1BJ, UK; Complete Fertility Centre, Princess Anne Hospital, Coxford Road, Southampton SO16 5YA, UK.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.022']
3301,32444190,Investigation of the effect of web-based diabetes education on metabolic parameters in people with type 2 diabetes: A randomized controlled trial.,"OBJECTIVES


The study was done experimentally to test the effect of diabetes on body mass index (BMI), low-density lipoprotein (LDL), high-density lipoprotein (HDL), systolic blood pressure, diastolic blood pressure, fasting blood glucose and postprandial blood glucose.
METHODS


In the randomization performed, with 80 percent power, 80 people with Type 2 diabetes were found to be suitable for sampling. Personal data forms were filled in by conducting a face-to-face interview with both the experimental and control groups for randomization purposes. In the study, monitoring of BMI, LDL, HDL, systolic blood pressure, diastolic blood pressure, fasting blood glucose and postprandial blood glucose were used as outcome measures. Parameters were monitored pre-trial and at the 3rd, 6th, 9th, and 12th months. Data from the experimental group were collected online while data belonging to the control group were collected by the researcher from patients' medical records in the Endocrinology Outpatient Clinic. Repeated measures analysis of variance (rANOVA) was performed to analyze pre-trial, 3rd, 6th, 9th, and 12th-month data.
RESULTS


BMI, LDL, HDL, systolic and diastolic blood pressure, fasting and postprandial blood glucose average of the experimental group at 12 months were proven to be ameliorated compared to the average values at the start of the study (month 0).
CONCLUSIONS


The metabolic data of the experimental group, who had web-based diabetes education, significantly improved between the start of the study (month 0) and the 12th month. In this era of technology, the importance of web-based monitoring of diabetes patients was once again proven.",2020,"RESULTS


BMI, LDL, HDL, systolic and diastolic blood pressure, fasting and postprandial blood glucose average of the experimental group at 12 months were proven to be ameliorated compared to the average values at the start of the study (month 0).
","['people with type 2 diabetes', '80 people with Type 2 diabetes']",['web-based diabetes education'],"['metabolic parameters', 'BMI, LDL, HDL, systolic and diastolic blood pressure, fasting and postprandial blood glucose average', 'body mass index (BMI), low-density lipoprotein (LDL), high-density lipoprotein (HDL), systolic blood pressure, diastolic blood pressure, fasting blood glucose and postprandial blood glucose', 'BMI, LDL, HDL, systolic blood pressure, diastolic blood pressure, fasting blood glucose and postprandial blood glucose']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",80.0,0.0197737,"RESULTS


BMI, LDL, HDL, systolic and diastolic blood pressure, fasting and postprandial blood glucose average of the experimental group at 12 months were proven to be ameliorated compared to the average values at the start of the study (month 0).
","[{'ForeName': 'Elif Unsal', 'Initials': 'EU', 'LastName': 'Avdal', 'Affiliation': 'Izmir Kâtip Çelebi University, Faculty of Health Sciences, Izmir, Turkey. Electronic address: elifunsal2003@yahoo.com.'}, {'ForeName': 'Berna Nilgün Özgürsoy', 'Initials': 'BNÖ', 'LastName': 'Uran', 'Affiliation': 'Izmir Kâtip Çelebi University, Faculty of Health Sciences, Izmir, Turkey.'}, {'ForeName': 'Gulseren', 'Initials': 'G', 'LastName': 'Pamuk', 'Affiliation': 'Izmir Kâtip Çelebi University, Faculty of Medicine, Izmir, Turkey.'}, {'ForeName': 'Julide Gulizar', 'Initials': 'JG', 'LastName': 'Yildirim', 'Affiliation': 'Izmir Kâtip Çelebi University, Faculty of Health Sciences, Izmir, Turkey.'}, {'ForeName': 'Gülbin', 'Initials': 'G', 'LastName': 'Konakçi', 'Affiliation': 'Izmir Demokrasi University. Faculty of Health Science, Izmir, Turkey.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Ateş', 'Affiliation': 'Burdur Mehmet Akif Ersoy University Faculty of Health Science, Burdur, Turkey.'}, {'ForeName': 'Gökşen', 'Initials': 'G', 'LastName': 'Polat', 'Affiliation': 'Izmir Kâtip Çelebi University, Enstitue of Health Sciences, Izmir, Turkey.'}]",Journal of infection and public health,['10.1016/j.jiph.2020.03.008']
3302,32445190,"The Pharmacokinetics, Efficacy, and Safety of a Novel Selective-Dose Cannabis Inhaler in Patients with Chronic Pain: A Randomized, Double-Blinded, Placebo-Controlled Trial.","BACKGROUND


Precise cannabis treatment dosing remains a major challenge, leading to physicians' reluctance to prescribe medical cannabis.
OBJECTIVE


To test the pharmacokinetics, analgesic effect, cognitive performance, and safety effects of an innovative medical device that enables the delivery of inhaled therapeutic doses of Δ 9  -Tetrahydrocannabinol (THC) in patients with chronic pain.
METHODS


In a randomized, 3-arms, double-blinded, placebo-controlled, cross-over trial, 27 patients received a single inhalation of Δ 9  -THC: 0.5mg, 1mg, or a placebo. Δ 9  -THC plasma levels were measured at baseline and up to 150-minutes post-inhalation. Pain intensity and safety parameters were recorded on a 10-cm visual analogue scale (VAS) at pre-defined time points. Cognitive performance was evaluated using the selective sub-tests of the Cambridge Neuropsychological Test Automated Battery (CANTAB).
RESULTS


Following inhalation of 0.5mg or 1mg, Δ 9  -THC plasma C max  ±SD were 14.3±7.7 and 33.8±25.7 ng/ml. T max  ±SD were 3.7±1.4 and 4.4±2.1 minutes, and AUC 0  → infinity  ±SD were 300±144 and 769±331 ng*min/ml respectively. Both doses, but not the placebo, demonstrated a significant reduction in pain intensity compared with baseline and remained stable for 150-minutes. The 1mg dose showed a significant pain decrease compared to the placebo. Adverse events were mostly mild and resolved spontaneously. There was no evidence of consistent impairments in cognitive performance.
CONCLUSION


This feasibility trial demonstrated that a metered-dose cannabis inhaler delivered precise and low THC doses, produced a dose-dependent and safe analgesic effect in patients with neuropathic pain/ complex-regional pain syndrome (CRPS). Thus, it enables individualization of medical cannabis regimens that can be evaluated pharmacokinetically and pharmacodynamically by accepted pharmaceutical models.",2020,"Both doses, but not the placebo, demonstrated a significant reduction in pain intensity compared with baseline and remained stable for 150-minutes.","['Patients with Chronic Pain', '27 patients received a', 'patients with chronic pain', 'patients with neuropathic pain/ complex-regional pain syndrome (CRPS']","['THC', 'Placebo', 'single inhalation of Δ 9  -THC', 'Novel Selective-Dose Cannabis Inhaler', 'Tetrahydrocannabinol', 'placebo']","['pharmacokinetics, analgesic effect, cognitive performance, and safety effects', 'T max  ±SD', 'cognitive performance', 'Pharmacokinetics, Efficacy, and Safety', 'Adverse events', 'pain intensity', 'THC plasma levels', 'Pain intensity and safety parameters', 'pain decrease', 'Cognitive performance', '10-cm visual analogue scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",27.0,0.690991,"Both doses, but not the placebo, demonstrated a significant reduction in pain intensity compared with baseline and remained stable for 150-minutes.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Almog', 'Affiliation': 'Department of Physiology & Pharmacology, Sackler School of Medicine, Tel-Aviv University, and Institute of Pharmacology & Toxicology, Chaim Sheba Medical Center, Tel-Hashomer, Israel.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Aharon-Peretz', 'Affiliation': 'Neuropsychology Unit, Rambam Health Care Campus, Faculty of Medicine, Technion, Haifa, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vulfsons', 'Affiliation': 'Institute of Pain Medicine, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ogintz', 'Affiliation': 'Institute of Pain Medicine, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Abalia', 'Affiliation': 'Syqe Medical LTD, Tel-Aviv, Israel.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lupo', 'Affiliation': 'Syqe Medical LTD, Tel-Aviv, Israel.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hayon', 'Affiliation': 'Syqe Medical LTD, Tel-Aviv, Israel.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Eisenberg', 'Affiliation': 'Institute of Pain Medicine, Rambam Health Care Campus, Haifa, Israel.'}]","European journal of pain (London, England)",['10.1002/ejp.1605']
3303,32445215,Comparative clinical study on microwave ablation combined with cisplatin plus gemcitabine or pemetrexed in treatment of advanced NSCLC.,"OBJECTIVE


Solving the limitations of single chemotherapy in the treatment of non-small cell lung cancer (NSCLC).
METHODS


100 patients with NSCLC treated in First Hospital of Jiaxing, Zhejiang from June 2016 to June 2018 were selected and randomly divided into MPC group and MGC group, with 50 cases in each group. The patients in MPC group were treated with MWA combined with PC while patients in MGC group were given MWA combined with GC. The therapeutic effects of the two groups as well as the complications and ADRs were observed and recorded.
RESULTS


There was no significant difference in disease response rate (MPC group 33.3% vs. MGC group 32.0%), disease control rate (MPC group 86.4% vs. MGC group 78.0%) and overall survival (1-, 2- and 3-year survival, MPC group 65%, 59%, 32.7% vs. MGC group 58%, 46%, 30%) between the two groups. In addition, the ADR myelosuppression was slighter in MPC group. There were 12 cases (23%) developed myelosuppression in the MPC group and 20 cases (42%) in MGC group, with a significant difference between the two groups (P<0.05). The treatment was interrupted for 0 case (0%) in MPC group due to myelosuppression while 4 cases (8.3%) in MGC group.
CONCLUSION


The two therapeutic regimens have similar efficacy in treatment of advanced NSCLC, but MPC causes slighter myelosuppression and can be the first-line therapy for advanced NSCLC.",2020,"There was no significant difference in disease response rate (MPC group 33.3% vs. MGC group 32.0%), disease control rate (MPC group 86.4% vs. MGC group 78.0%) and overall survival (","['100 patients with NSCLC treated in First Hospital of Jiaxing, Zhejiang from June 2016 to June 2018', 'non-small cell lung cancer (NSCLC', 'advanced NSCLC']","['cisplatin plus gemcitabine or pemetrexed', 'single chemotherapy', 'MPC group and MGC', 'MWA combined with GC', 'MWA combined with PC']","['complications and ADRs', 'disease control rate', '1-, 2- and 3-year survival', 'overall survival', 'disease response rate', 'ADR myelosuppression', 'myelosuppression']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}]",100.0,0.0331002,"There was no significant difference in disease response rate (MPC group 33.3% vs. MGC group 32.0%), disease control rate (MPC group 86.4% vs. MGC group 78.0%) and overall survival (","[{'ForeName': 'YingQing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Medicine, First Hospital of Jiaxing, 314000, Jiaxing, CN, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Respiratory Medicine, First Hospital of Jiaxing, 314000, Jiaxing, CN, China.'}, {'ForeName': 'YongLei', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Respiratory Medicine, First Hospital of Jiaxing, 314000, Jiaxing, CN, China.'}, {'ForeName': 'YingXin', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, First Hospital of Jiaxing, 314000, Jiaxing, CN, China.'}, {'ForeName': 'LinLan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation, First Hospital of Jiaxing, 314000, Jiaxing, CN, China.'}]",The clinical respiratory journal,['10.1111/crj.13219']
3304,32445434,Antibacterial prophylaxis of febrile neutropenia is not effective in the pre-engraftment period in pediatric allogeneic hematopoietic stem cell transplantation.,"the recently published guideline by Lehrnbecher et al [1] on antibacterial prophylaxis for prevention of febrile neutropenia in cancer children gives a weak recommendation with a moderate quality evidence not to administer systemic antibacterial prophylaxis for children undergoing allogeneic hematopoietic stem cell transplantation (HSCT). This recommendation was based mainly on a single randomized clinical trial [2], showing no effectiveness of levofloxacin compared to no prophylaxis (effectiveness 11.0% vs 17.3%; risk difference: 6.3%; p =0.06).",2020,"This recommendation was based mainly on a single randomized clinical trial [2], showing no effectiveness of levofloxacin compared to no prophylaxis (effectiveness 11.0% vs 17.3%; risk difference: 6.3%; p =0.06).","['cancer children', 'pediatric allogeneic hematopoietic stem cell transplantation', 'children undergoing allogeneic hematopoietic stem cell transplantation (HSCT']",['levofloxacin'],[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}]",[],2.0,0.0676499,"This recommendation was based mainly on a single randomized clinical trial [2], showing no effectiveness of levofloxacin compared to no prophylaxis (effectiveness 11.0% vs 17.3%; risk difference: 6.3%; p =0.06).","[{'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Ricci', 'Affiliation': ""Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, and Maternal and Children's Sciences, University of Genova, Genova, Italy.""}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Mesini', 'Affiliation': 'Infectious Diseases Unit, Department of Pediatrics, IRCCS Istituto Giannina Gaslini, Genova, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bandettini', 'Affiliation': 'Department of laboratory Medicine, Microbiology Service, IRCCS Istituto Giannina Gaslini, Genova, Italy.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Faraci', 'Affiliation': 'SCT Unit- Paediatric Haematology, Oncology Department, IRCCS Istituto Giannina Gaslini, Genova, Italy.'}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Castagnola', 'Affiliation': 'Infectious Diseases Unit, Department of Pediatrics, IRCCS Istituto Giannina Gaslini, Genova, Italy.'}]",Transplant infectious disease : an official journal of the Transplantation Society,['10.1111/tid.13340']
3305,32445498,Effect of Fremanezumab Monthly and Quarterly Doses on Efficacy Responses.,"OBJECTIVE


Exposure-response (E-R) models were developed to provide a description of the time-course of treatment effect for monthly and quarterly dosing regimens of fremanezumab.
BACKGROUND


Fremanezumab is a monoclonal antibody for preventive treatment of episodic migraine (EM) and chronic migraine (CM). In phase 2b and 3 clinical studies of fremanezumab, significant reductions in migraine and headache days and other clinical endpoints were observed for patients with EM and patients with CM. Development of E-R models relating individual-specific measures of drug exposure to clinical endpoints provides a more granular understanding of the expected effects of different doses on therapeutic outcomes by accounting for variability in pharmacokinetic (PK) properties.
METHODS


Data from 2 phase 2b and 2 phase 3 studies of adults with EM or CM were used. Individual exposures were calculated from a population PK model and related to monthly migraine days in EM and moderate-severe (M/S) headache days in CM. Model-based stochastic simulations were performed to compare predicted responses for the various treatment regimens.
RESULTS


The effect of average fremanezumab concentration compared to placebo on the reduction in migraine days and M/S headache days was predicted by the models to be similar for 225 mg monthly and 675 mg once quarterly over time for both EM and CM patients. Both regimens were associated with better response than placebo. A similar percent of EM and CM responders was predicted across the range of observed body weights.
CONCLUSIONS


Exposure-response evaluations showed that both monthly (225 mg) and quarterly (675 mg) fremanezumab dosing regimens were appropriate in achieving clinical benefit in adult patients with EM or CM.",2020,"In phase 2b and 3 clinical studies of fremanezumab, significant reductions in migraine and headache days and other clinical endpoints were observed for patients with EM and patients with CM.","['adult patients with EM or CM', 'Data from 2 phase 2b and 2 phase 3 studies of adults with EM or CM were used']","['Fremanezumab', 'fremanezumab', 'placebo']","['migraine days and M/S headache days', 'Efficacy Responses', 'migraine and headache days']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0439560', 'cui_str': 'Phase 2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0603915,"In phase 2b and 3 clinical studies of fremanezumab, significant reductions in migraine and headache days and other clinical endpoints were observed for patients with EM and patients with CM.","[{'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Fiedler-Kelly', 'Affiliation': 'Cognigen Corporation (a Simulations Plus company), Buffalo, NY, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Passarell', 'Affiliation': 'Cognigen Corporation (a Simulations Plus company), Buffalo, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ludwig', 'Affiliation': 'Cognigen Corporation (a Simulations Plus company), Buffalo, NY, USA.'}, {'ForeName': 'Micha', 'Initials': 'M', 'LastName': 'Levi', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Cohen-Barak', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Netanya, Israel.'}]",Headache,['10.1111/head.13845']
3306,32441987,A Randomized Trial of Behavioral Nudges to Improve Enrollment in Critical Care Trials.,"RATIONALE


Low and slow patient enrollment remains a barrier to critical care randomized controlled trials (RCTs). Behavioral economic insights suggest that nudges may address some enrollment challenges.
OBJECTIVES


To evaluate the efficacy of a novel pre-consent survey consisting of nudges on critical care RCT enrollment.
METHODS


We conducted an RCT in 10 intensive care units (ICUs) among surrogate decision-makers (SDMs). The novel multi-component behavioral nudge survey was administered immediately prior to soliciting SDMs' informed consent for their patients' participation in a sham trial of two mechanical ventilation weaning approaches in acute respiratory failure (ARF). The primary outcome was the enrollment rate for the sham trial. Secondary outcomes included undue and unjust inducements. We also explored SDM and patient predictors of enrollment using multivariate regression.
RESULTS


Among 182 SDMs, 93 were randomized to receive the intervention survey and 89 to receive standard informed consent. There was no statistically significant difference in enrollment rates between the intervention (29%) and standard consent (34%) groups (percentage difference 5%; 95% CI, -9% to 18%, p=0.50). There was no evidence of undue or unjust inducement. Caucasian SDMs were more likely to enroll the patient compared to non-Caucasian SDMs (OR 3.7, 95%CI 1.1-12.2, p=0.03). SDMs who perceived a higher risk of participation were less likely to enroll the patient (OR 0.57 95%CI 0.46-0.71, p<0.001).
CONCLUSIONS


A pre-consent behavioral nudge survey among SDMs of patients with ARF in the ICU did not increase enrollment rates for a sham RCT compared to standard informed consent procedures. Clinical trial registered with ClinicalTrials.gov (NCT03284359).",2020,"There was no statistically significant difference in enrollment rates between the intervention (29%) and standard consent (34%) groups (percentage difference 5%; 95% CI, -9% to 18%, p=0.50).",['10 intensive care units (ICUs) among surrogate decision-makers (SDMs'],['mechanical ventilation weaning approaches'],"['enrollment rate', 'enrollment rates', 'Caucasian SDMs', 'undue and unjust inducements']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0554244', 'cui_str': 'Maker'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]",2.0,0.317179,"There was no statistically significant difference in enrollment rates between the intervention (29%) and standard consent (34%) groups (percentage difference 5%; 95% CI, -9% to 18%, p=0.50).","[{'ForeName': 'Dustin C', 'Initials': 'DC', 'LastName': 'Krutsinger', 'Affiliation': 'University of Nebraska Medical Center, 12284, Medicine, Omaha, Nebraska, United States; dustin.krutsinger@unmc.edu.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': ""O'Leary"", 'Affiliation': 'CHOP, 6567, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Perelman School of Medicine, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Cody E', 'Initials': 'CE', 'LastName': 'Cotner', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 14640, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Halpern', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 14640, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Courtright', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 14640, Medicine, Philadelphia, Pennsylvania, United States.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202003-194OC']
3307,32442026,The Use of the Apron and Disaster Baby Carriers to Improve the Exclusive Breastfeeding Self-Efficacy of Mothers in Disaster-Affected Zones in Indonesia.,"Disasters have psychological effects on breastfeeding mothers due to the high potential to reduce the production of breast milk, which may affect the ability of breastfeeding mothers to provide nutritious food to their babies. The stress from natural disasters and post-disaster conditions can affect lactation by lowering the oxytocin hormone in nursing mothers. Since supplies of baby food and formula may be limited during a disaster, the most practical and affordable way for a mother to feed her baby is to continue providing breast milk. This research was conducted to identify the effectiveness of the Breastfeeding Education Program (BEP) using apron and Disaster Evacuation Baby Carrier (DEBC) in increasing breastfeeding-mothers' self efficacy in disaster-affected areas. This research employed a quantitative method involving 74 women. The samples were collected using a cluster randomized controlled trial sampling at four sub-districts in Southeast Minahasa Regency, North Sulawesi, Indonesia. Data were analyzed using an independent t-test to determine mean differences between the intervention group and the control group. The results showed differences in mean score of Breastfeeding Self-Efficacy between the control and intervention groups ( p  value = 0.001). Apron and DEBC in the BEP increased the self-efficacy scores of mothers who exclusively breastfeed in disaster-affected zones. Healthcare workers who implement the BEP in disaster-affected zones are encouraged to include breastfeeding success strategies such as apron and DEBC to strengthen mothers' capacity to cope with disaster-related conditions.",2020,Apron and DEBC in the BEP increased the self-efficacy scores of mothers who exclusively breastfeed in disaster-affected zones.,"['nursing mothers', '74 women', 'Healthcare workers']",['Breastfeeding Education Program (BEP) using apron and Disaster Evacuation Baby Carrier (DEBC'],"['self-efficacy scores', 'mean score of Breastfeeding Self-Efficacy']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0418914', 'cui_str': 'Breastfeeding education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0179129', 'cui_str': 'Apron'}, {'cui': 'C0012618', 'cui_str': 'Disasters'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]",74.0,0.0319861,Apron and DEBC in the BEP increased the self-efficacy scores of mothers who exclusively breastfeed in disaster-affected zones.,"[{'ForeName': 'Dorce Sisfiani', 'Initials': 'DS', 'LastName': 'Sarimin', 'Affiliation': 'Department of Pediatric Nursing, Polytechnic Ministry of Health Manado, Manado, Indonesia.'}, {'ForeName': 'Tati Setyawati', 'Initials': 'TS', 'LastName': 'Ponidjan', 'Affiliation': 'Department of Pediatric Nursing, Polytechnic Ministry of Health Manado, Manado, Indonesia.'}, {'ForeName': 'Dessie', 'Initials': 'D', 'LastName': 'Wanda', 'Affiliation': 'Department of Pediatric Nursing, Faculty of Nursing, Universitas Indonesia, Depok, Indonesia.'}]",Comprehensive child and adolescent nursing,['10.1080/24694193.2020.1761481']
3308,32442094,Sevoflurane Consumption During Inhalational Induction in Children: A Randomized Comparison of Minute Ventilation-Based Techniques With Standard Fixed Fresh Gas Flow Technique.,"This study was done to ascertain the optimum fresh gas flow (FGF) offering the best balance between rapid induction and minimal waste in pediatric patients. Forty-five children (weighing 10-20 kg) undergoing elective procedures under general anesthesia were randomly assigned into 3 groups: 0.5 minute ventilation (MV), MV, and S (FGF = 6 L/min). After priming the pediatric closed circuit, anesthesia was induced using a face mask with 8% sevoflurane in 100% oxygen (Draeger Primus Vista 120 anesthesia machine) at FGF-determined MV per group allocation. After loss of eyelash reflex (time 1 [T1]), intravenous cannulation (T2) and laryngeal mask airway (LMA) placement (T3) were done. Total sevoflurane consumed during induction (measured using logbook function) was the primary outcome. The cost of sevoflurane, any reflex movement, tachycardia (heart rate change > 20%), or additional propofol boluses required were also recorded. Sevoflurane consumption (3.8 vs 5.8 vs 9.2 mL) and cost of sevoflurane (104.2 vs 199.4 vs 312.8 rupees) were lowest in group 0.5 MV (P < .001). There was no difference in hemodynamic parameters, movement on cannulation/LMA insertion, and rescue propofol boluses required. For pediatric sevoflurane induction, half the MV-based FGF provided similar anesthetic conditions for LMA insertion with minimum sevoflurane consumption.",2020,"There was no difference in hemodynamic parameters, movement on cannulation/LMA insertion, and rescue propofol boluses required.","['Forty-five children (weighing 10-20 kg) undergoing elective procedures under general anesthesia', 'Children', 'pediatric patients']","['sevoflurane', 'Sevoflurane Consumption', 'Total sevoflurane', 'Minute Ventilation-Based Techniques With Standard Fixed Fresh Gas Flow Technique']","['eyelash reflex (time 1 [T1]), intravenous cannulation (T2) and laryngeal mask airway (LMA) placement (T3', 'cost of sevoflurane', 'cost of sevoflurane, any reflex movement, tachycardia (heart rate change > 20%), or additional propofol boluses', 'hemodynamic parameters, movement on cannulation/LMA insertion, and rescue propofol boluses required', 'Sevoflurane consumption']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0747973', 'cui_str': 'Elective procedure'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0428716', 'cui_str': 'Fresh gas flow'}]","[{'cui': 'C0422906', 'cui_str': 'Eyelash reflex'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0396618', 'cui_str': 'Laryngeal mask airway insertion'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",120.0,0.214744,"There was no difference in hemodynamic parameters, movement on cannulation/LMA insertion, and rescue propofol boluses required.","[{'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'is an assistant professor in the Department of Anaesthesia, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Priyankar K', 'Initials': 'PK', 'LastName': 'Datta', 'Affiliation': 'is an anesthesiologist in the Department of Anaesthesiology and Intensive Care, All India Institute of Medical Sciences, New Delhi, India.'}]",AANA journal,[]
3309,32442301,Adult cord blood transplant results in comparable overall survival and improved GRFS vs matched related transplant.,"We compared outcomes among adult matched related donor (MRD) patients undergoing peripheral blood stem cell transplantation and adult patients undergoing double unit cord blood transplantation (CBT) at our center between 2010 and 2017. A total of 190 CBT patients were compared with 123 MRD patients. Median follow-up was 896 days (range, 169-3350) among surviving CBT patients and 1262 days (range, 249-3327) among surviving MRD patients. Comparing all CBT with all MRD patients, overall survival (OS) was comparable (P = .61) and graft-versus-host disease (GVHD) relapse-free survival (GRFS) was significantly improved among CBT patients (P = .0056), primarily because of decreased moderate to severe chronic GVHD following CBT (P < .0001; hazard ratio [HR], 3.99; 95% confidence interval [CI], 2.26-7.04). Among patients undergoing our most commonly used MRD and umbilical cord blood (CB) myeloablative regimens, OS was comparable (P = .136) and GRFS was significantly improved among CBT patients (P = .006). Cumulative incidence of relapse trended toward decreased in the CBT group (P = .075; HR, 1.85; CI 0.94-3.67), whereas transplant-related mortality (TRM) was comparable (P = .55; HR, 0.75; CI, 0.29-1.95). Among patients undergoing our most commonly used nonmyeloablative regimens, OS and GRFS were comparable (P = .158 and P = .697). Cumulative incidence of both relapse and TRM were comparable (P = .32; HR, 1.35; CI, 0.75-2.5 for relapse and P = .14; HR, 0.482; CI, 0.18-1.23 for TRM). Our outcomes support the efficacy of CBT and suggest that among patients able to tolerate more intensive conditioning regimens at high risk for relapse, CB may be the preferred donor source.",2020,"Cumulative incidence of both relapse and TRM were comparable (P = .32; HR, 1.35; CI, 0.75-2.5 for relapse and P = .14; HR, 0.482; CI, 0.18-1.23 for TRM).","['190 CBT patients were compared with 123 MRD patients', 'adult matched related donor (MRD) patients undergoing peripheral blood stem cell transplantation and adult patients undergoing double unit cord blood transplantation (CBT) at our center between 2010 and 2017']",['CBT'],"['overall survival and improved GRFS', 'nonmyeloablative regimens, OS and GRFS', 'MRD and umbilical cord blood (CB) myeloablative regimens, OS', 'GRFS', 'Cumulative incidence of relapse', 'Cumulative incidence of both relapse and TRM', 'transplant-related mortality (TRM', 'overall survival (OS', 'graft-versus-host disease (GVHD) relapse-free survival (GRFS', 'severe chronic GVHD']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242602', 'cui_str': 'Peripheral blood stem cell graft'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}]",190.0,0.0849146,"Cumulative incidence of both relapse and TRM were comparable (P = .32; HR, 1.35; CI, 0.75-2.5 for relapse and P = .14; HR, 0.482; CI, 0.18-1.23 for TRM).","[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Enkhtsetseg', 'Initials': 'E', 'LastName': 'Purev', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Haverkos', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Pollyea', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Cherry', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Manali', 'Initials': 'M', 'LastName': 'Kamdar', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Tomer', 'Initials': 'T', 'LastName': 'Mark', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Forsberg', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sherbenou', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hammes', 'Affiliation': 'Center for Innovative Design and Analysis, Department of Biostatistics and Informatics, and.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Rabinovitch', 'Affiliation': 'Department of Radiation Oncology, University of Colorado, Aurora, CO.'}, {'ForeName': 'Clayton A', 'Initials': 'CA', 'LastName': 'Smith', 'Affiliation': 'Division of Hematology.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Gutman', 'Affiliation': 'Division of Hematology.'}]",Blood advances,['10.1182/bloodadvances.2020001554']
3310,32442334,Early 3-month treatment with comprehensive physical therapy program restores continence in urinary incontinence patients after radical prostatectomy: A randomized controlled trial.,"AIMS


The objective of this study is to ascertain whether an early three-month treatment with electrotherapy and biofeedback restores continence in urinary incontinence patients after radical prostatectomy (RP).
METHODS


Design: The study performed a randomized, controlled trial of parallel and open groups. Configuration: Secondary care, urology department of a university hospital complex.
PARTICIPANTS


Patients sent for RP due to prostate cancer (n = 60), 47 patients finally completed the study.
INTERVENTIONS


The treatment group (TG) received physiotherapy consisting of electrotherapy and biofeedback, 3 days a week for 3 months, while the control group (CG) received no specific treatment. Both groups received a guide to perform pelvic floor exercises at home. The measurement instruments used were the 1- and 24-hour pad tests and the International Consultation on Incontinence Questionnaire Short-Form. The recording method used was a micturition (urinary) diary.
RESULTS


The results of the 1-hour pad test (PT) show statistically significant differences between groups at 3 months (P = .001) and 6 months (P = .001), in favor of those in the TG. Sixty-four percent of patients in the TG recovered continence as against 9.1% in the CG after 3 months in the 1-hour PT, in line with the objective of this study.
CONCLUSIONS


An early physiotherapy program helps RP patients with urinary incontinence recover continence after 3 months. Moreover, they lead a better quality life.",2020,"Sixty-four percent of patients in the TG recovered continence as against 9.1% in the CG after 3 months in the 1-hour PT, in line with the objective of this study.
","['urinary incontinence patients after radical prostatectomy', 'Patients sent for RP\xa0due to prostate cancer (n\u2009=\u200960), 47 patients finally completed the study', 'urinary incontinence patients after radical prostatectomy (RP']","['Configuration', 'guide to perform pelvic floor exercises at home', 'physiotherapy program', 'control group (CG) received no specific treatment', 'comprehensive physical therapy program restores continence', 'electrotherapy and biofeedback restores continence', 'physiotherapy consisting of electrotherapy\xa0and biofeedback']","['quality life', 'urinary incontinence recover continence']","[{'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0262718', 'cui_str': 'Pelvic floor exercises'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}]",,0.0525782,"Sixty-four percent of patients in the TG recovered continence as against 9.1% in the CG after 3 months in the 1-hour PT, in line with the objective of this study.
","[{'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Soto González', 'Affiliation': 'Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Vigo, Spain.'}, {'ForeName': 'Iria', 'Initials': 'I', 'LastName': 'Da Cuña Carrera', 'Affiliation': 'Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Vigo, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Gutiérrez Nieto', 'Affiliation': 'Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Vigo, Spain.'}, {'ForeName': 'Sabela', 'Initials': 'S', 'LastName': 'López García', 'Affiliation': 'Urology Service, University Hospital Complex of Vigo, Vigo, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ojea Calvo', 'Affiliation': 'Urology Service, University Hospital Complex of Vigo, Vigo, Spain.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Lantarón Caeiro', 'Affiliation': 'Department of Functional Biology and Health Sciences, Faculty of Physiotherapy, University of Vigo, Vigo, Spain.'}]",Neurourology and urodynamics,['10.1002/nau.24389']
3311,32442353,A randomized controlled clinical trial comparing the use of displacement cords and aluminum chloride paste.,"OBJECTIVES


This clinical study measured the change in opening and height of the displaced gingiva using paste and cord retraction materials for definitive impression making of natural teeth and assessed if they were comparable and clinically acceptable.
METHODS


Impressions of 4 maxilla premolars from 10 participants were taken using a split-mouth protocol. All participants were free of periodontal disease, had a thick biotype, a minimal of 3 mm height of keratinized gingival tissue and gingival sulci depths of 2 mm. The bleeding index (BI), gingival index (GI) plaque index (PI), sulcular depth, level of attachment and tooth sensitivity were recorded at baseline, just after retraction, at 24 hours and at 2 weeks. Impressions were poured in stone and then after initial analysis were cross-sectioned to allow measurements of the gingival height change and gap size to be recorded.
RESULTS


The paste produced a slightly smaller gap compared to the cord (0.041 mm less, P = .014) whilst the mean displacement for the cord was 0.282 mm and paste was 0.241 mm respectively. Gingival height with the paste was 0.047 mm lower than that achieved by the cord (P = .208).
CONCLUSIONS


Cord and paste retraction produced comparable clinically acceptable gingival gaps, with the cord producing statistically larger gap size.
CLINICAL SIGNIFICANCE


The cord and paste retraction materials produced comparable clinically acceptable gingival retraction.",2020,"The paste produced a slightly smaller gap compared to the cord (0.041 mm less, P = .014) whilst the mean displacement for the cord was 0.282 mm and paste was 0.241 mm respectively.","['All participants were free of periodontal disease, had a thick biotype, a minimal of 3\u2009mm height of keratinized gingival tissue and gingival sulci depths of 2\u2009mm', 'Impressions of 4 maxilla premolars from 10 participants were taken using a split-mouth protocol']",['displacement cords and aluminum chloride paste'],"['bleeding index (BI), gingival index (GI) plaque index (PI), sulcular depth, level of attachment and tooth sensitivity', 'acceptable gingival retraction', 'Gingival height']","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0441707', 'cui_str': 'Biotyping'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0317562', 'cui_str': 'Eubacterium sulci'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0051512', 'cui_str': 'Aluminum chloride hexahydrate'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",10.0,0.0760322,"The paste produced a slightly smaller gap compared to the cord (0.041 mm less, P = .014) whilst the mean displacement for the cord was 0.282 mm and paste was 0.241 mm respectively.","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Bennani', 'Affiliation': 'Department of Oral Rehabilitation, Faculty of Dentistry, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Aarts', 'Affiliation': 'Department of Oral Rehabilitation, Faculty of Dentistry, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brunton', 'Affiliation': 'Pro Vice Chancellor Health Sciences, University of Otago, Dunedin, New Zealand.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12581']
3312,32443329,A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections.,"BACKGROUND


An increased frequency of toxoplasma encephalitis, caused by Toxoplasma gondii, has been reported in AIDS patients, especially in those with CD4+ T cell counts <100 cells/μL. Several guidelines recommend the combination of pyrimethamine, sulfadiazine, and leucovorin as the preferred regimen for AIDS-associated toxoplasma encephalitis. However, it is not commonly used in China due to limited access to pyrimethamine and sulfadiazine. The synergistic sulfonamides tablet formulation is a combination of trimethoprim (TMP), sulfadiazine and sulfamethoxazole (SMX), and is readily available in China. Considering its constituent components, we hypothesize that this drug may be used as a substitute for sulfadiazine and TMP-SMX. We have therefore designed the present trial, and propose to investigate the efficacy and safety of synergistic sulfonamides combined with clindamycin for the treatment of toxoplasma encephalitis.
METHODS/DESIGN


This study will be an open-labeled, multi-center, prospective, randomized, and controlled trial. A total of 200 patients will be randomized into TMP-SMX plus azithromycin group, and synergistic sulfonamides plus clindamycin group at a ratio of 1:1. All participants will be invited to participate in a 48-week follow-up schedule once enrolled. The primary outcomes will be clinical response rate and all-cause mortality at 12 weeks. The secondary outcomes will be clinical response rate and all-cause mortality at 48 weeks, and adverse events at each visit during the follow-up period.
DISCUSSION


We hope that the results of this study will be able to provide reliable evidence for the efficacy and safety of synergistic sulfonamides for its use in AIDS patients with toxoplasma encephalitis.
TRIAL REGISTRATION


This study was registered as one of 12 clinical trials under the name of a general project at chictr.gov on February 1, 2019, and the registration number of the general project is ChiCTR1900021195. This study is still recruiting now, and the first patient was screened on March 22, 2019.",2020,"The secondary outcomes will be clinical response rate and all-cause mortality at 48 weeks, and adverse events at each visit during the follow-up period.
","['12 clinical trials under the name of a general project at chictr.gov on February 1, 2019, and the registration number of the general project is ChiCTR1900021195', 'difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections', '200 patients', 'AIDS patients with toxoplasma encephalitis']","['clindamycin', 'synergistic sulfonamides plus clindamycin', 'pyrimethamine', 'TMP-SMX plus azithromycin', 'trimethoprim (TMP), sulfadiazine and sulfamethoxazole (SMX', 'pyrimethamine, sulfadiazine, and leucovorin']","['clinical response rate and all-cause mortality', 'clinical response rate and all-cause mortality at 48 weeks, and adverse events']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0085315', 'cui_str': 'Meningoencephalitis due to acquired toxoplasmosis'}]","[{'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0038760', 'cui_str': 'Sulfonamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034283', 'cui_str': 'Pyrimethamine'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0038675', 'cui_str': 'Sulfadiazine'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",200.0,0.11167,"The secondary outcomes will be clinical response rate and all-cause mortality at 48 weeks, and adverse events at each visit during the follow-up period.
","[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yan-Ming', 'Initials': 'YM', 'LastName': 'Zeng', 'Affiliation': ''}, {'ForeName': 'Yan-Qiu', 'Initials': 'YQ', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Qin', 'Affiliation': ''}, {'ForeName': 'Yao-Kai', 'Initials': 'YK', 'LastName': 'Chen', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020146']
3313,32443332,"Research ""recover from illness defense complex"" helper T cell immune mechanisms based on the ""Fuxie"" theory clearing away heat evil thoroughly nourishing kidney treatment of recurrent blood-heat syndrome Psoriasis.","INTRODUCTION


Psoriasis vulgaris (PV) is a chronic, painful, disfiguring, and disabling dermatological disease, which affects the physical and mental health of patients and impacts their quality of life. Current conventional systemic therapies can be costly, present risks of side effects, have limited efficacy and commonly recur following treatment cessation. Some Chinese herbal medicine therapies have shown therapeutic benefits for psoriasis vulgaris, including relieving symptoms and improving quality of life, and a potential of reducing relapse rate. However, explicit evidence has not yet been obtained.
METHODS AND ANALYSIS


This is a pilot randomized controlled trial with the objective of investigating the effect of Jia Wei Liang Xue Xiao Feng San granules on relapse rate of recurrent PV and the correlation between Psoriasis area severity index (PASI) and key psoriasis-related cytokine changes and the number of cells. A total of 102 participants were recruited for this study, including 72 patients with recurrent PV, 15 healthy volunteers and 15 patients with psoriasis vulgaris who have recovered for more than 1 year. A total of 72 patients, with recurrent PV, will be randomized (1:1) to receive the oral Chinese herbal medicine Jia Wei Liang Xue Xiao Feng San or the oral Acitretin Capsule treatments for a period of 8 weeks. After this period, participants whose PASI scores improvement reached more than 75%, will undergo a 52-week follow-up phase.The primary outcome measures are as follows:The secondary study outcomes will include:This trial may provide a novel regimen for recurrent PV patients if the granules decrease recurrence rate without further adverse effects.
ETHICS AND DISSEMINATION


The ethics approval was provided by the Sichuan Traditional Chinese medicine regional ethics review committee. The ethics approval number is 2018KL-055. The design and the results of the study will be disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR1900022766).",2020,"Some Chinese herbal medicine therapies have shown therapeutic benefits for psoriasis vulgaris, including relieving symptoms and improving quality of life, and a potential of reducing relapse rate.","['102 participants were recruited for this study, including 72 patients with recurrent PV, 15 healthy volunteers and 15 patients with psoriasis vulgaris who have recovered for more than 1 year', '72 patients, with recurrent PV']","['oral Chinese herbal medicine Jia Wei Liang Xue', 'Jia Wei Liang Xue Xiao Feng San granules']","['recurrence rate without further adverse effects', 'relapse rate of recurrent PV', 'PASI scores improvement']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",102.0,0.233689,"Some Chinese herbal medicine therapies have shown therapeutic benefits for psoriasis vulgaris, including relieving symptoms and improving quality of life, and a potential of reducing relapse rate.","[{'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Hospital of Chengdu University of traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Ping-Sheng', 'Initials': 'PS', 'LastName': 'Hao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020161']
3314,32443343,Impact of twice- or three-times-weekly maintenance hemodialysis on patient outcomes: A multicenter randomized trial.,"AIM


Maintenance hemodialysis (MHD) frequency is associated with survival and complication rates. Achieving the optimal balance between healthcare, quality of life (QOL), and medical costs is challenging. We compared complications, inflammatory status, nutritional status, and QOL between patients with different MHD frequencies.
MATERIAL AND METHODS


This was a multicenter randomized trial of patients treated between May 2011 and August 2017 at 3 tertiary hospitals in Wenzhou. Patients were grouped according to their treatment schedule over 1 year: twice-weekly or 3-times-weekly. Complications, biochemistry parameters, and QOL (KDQOL-SFTM 1.3 scale) were assessed.
RESULTS


One hundred forty patients were included aged 29 to 68 years (mean age, 50.9 ± 4.3 years). There were no significant differences in infection, heart failure, or cerebral hemorrhage complications between the 2 groups (P = .664). Pre-dialysis hemoglobin, high-sensitivity C-reactive protein, serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction were similar in both groups (P > .05). After 1 year of MHD, both groups exhibited significant improvements in these parameters (all P < .05) with no significant differences between groups. Serum creatinine, blood urea nitrogen (BUN), and weekly standard hemodialysis treatment adequacy did not improve after treatment (all P > .05), although a difference in BUN was observed between the 2 groups (P < .001). QOL was superior in the twice-weekly group than in the 3-times-weekly group (all P < .05), except for social support, which was slightly better in the 3-times-weekly group than in the twice-weekly group.
CONCLUSIONS


Twice- and 3-times-weekly MHD resulted in comparable inflammatory and nutritional clinical outcomes and adverse events. QOL was better for the twice-weekly schedule. Even for patients with economic constraints, twice- or 3-times-weekly MHD should be selected with caution after consideration of BUN levels at baseline.",2020,"serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction were similar in both groups (P > .05).","['patients treated between May 2011 and August 2017 at 3 tertiary hospitals in Wenzhou', 'One hundred forty patients were included aged 29 to 68 years (mean age, 50.9\u200a±\u200a4.3 years', 'patient outcomes']",['twice- or three-times-weekly maintenance hemodialysis'],"['Serum creatinine, blood urea nitrogen (BUN), and weekly standard hemodialysis treatment adequacy', 'serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction', 'QOL', 'BUN', 'inflammatory and nutritional clinical outcomes and adverse events', 'infection, heart failure, or cerebral hemorrhage complications', 'survival and complication rates', 'healthcare, quality of life (QOL), and medical costs', 'Complications, biochemistry parameters, and QOL (KDQOL-SFTM 1.3 scale', 'complications, inflammatory status, nutritional status, and QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}]",140.0,0.0354086,"serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction were similar in both groups (P > .05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': ""Department of Nephrology, Ruian People's Hospital, Ruian City, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Jinnv', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Huanlin', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Fadong', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Zengqi', 'Initials': 'Z', 'LastName': 'Xue', 'Affiliation': ''}, {'ForeName': 'Chusheng', 'Initials': 'C', 'LastName': 'Miao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020202']
3315,32443348,Adductor canal block with periarticular infiltration versus periarticular infiltration alone after total knee arthroplasty: A randomized controlled trial protocol.,"BACKGROUND


Effective postoperative analgesia may enhance early rehabilitation after total knee arthroplasty (TKA). The purpose of this study is to perform a randomized controlled trial to compare the efficiency of adductor canal block (ACB) with periarticular infiltration (PAI) versus PAI alone for early postoperative pain treatment after TKA.
METHODS


After institutional review board approval, written informed consent was obtained from patients undergoing elective TKA. Subjects were randomized into 2 groups as follows: adductor canal blockade with 30 mL of 0.5% ropivacaine and 100 mcg of clonidine. All patients received a periarticular infiltration mixture intraoperatively with scheduled and patient requested oral and IV analgesics postoperatively for breakthrough pain. The primary outcome was morphine consumption in the first 24 hours. Secondary outcomes included pain scores, morphine consumption at 48 hours, opioid-related side effects (post-operative nausea/vomiting, sedation scores), functional outcomes, quadriceps strength, and length of hospital stay.
CONCLUSIONS


For the present trial, we hypothesized that patients receiving adductor canal block + PAI would have significantly lower morphine consumption and pain scores after surgery.
TRIAL REGISTRATION NUMBER


researchregistry5490.",2020,"For the present trial, we hypothesized that patients receiving adductor canal block + PAI would have significantly lower morphine consumption and pain scores after surgery.
","['total knee arthroplasty (TKA', 'after total knee arthroplasty', 'patients undergoing elective TKA', 'early postoperative pain treatment after TKA']","['clonidine', 'periarticular infiltration mixture intraoperatively with scheduled and patient requested oral and IV analgesics', 'Adductor canal block with periarticular infiltration versus periarticular infiltration alone', 'adductor canal block (ACB) with periarticular infiltration (PAI) versus PAI alone', 'adductor canal blockade with 30\u200amL of 0.5% ropivacaine']","['morphine consumption', 'pain scores, morphine consumption at 48\u200ahours, opioid-related side effects (post-operative nausea/vomiting, sedation scores), functional outcomes, quadriceps strength, and length of hospital stay', 'morphine consumption and pain scores']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332153', 'cui_str': 'Requested by patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.331919,"For the present trial, we hypothesized that patients receiving adductor canal block + PAI would have significantly lower morphine consumption and pain scores after surgery.
","[{'ForeName': 'Yongcheng', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Jiacai', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Ophthalmology and Otorhinolaryngology, Qianjiang District Chinese medicine hospital of Chongqing, Chongqing, China.'}]",Medicine,['10.1097/MD.0000000000020213']
3316,32444035,Effects of hydroalcoholic extract of Berberis Integerrima on the anthropometric indices and metabolic profile in active rheumatoid arthritis patients.,"OBJECTIVES


Since, the main cause of death in Rheumatoid arthritis (RA) patients is the presence of type 2 diabetes, abnormal increase in blood lipids, blood pressure and obesity, the aim of this study was to assess the effects of Barberry on the anthropometric indices and metabolic profile in patients with RA.
DESIGN


present study was a double-blinded, placebo-controlled randomized clinical trial.
SETTING


70 active RA patients were randomly allocated into intervention or placebo group INTERVENTION: Participants received 6 capsules of 500 mg barberry extract or placebo for 3 months.
MAIN OUTCOME MEASURES


Serum levels of fasting blood sugar (FBS), triglyceride (TG), LDL cholesterol (LDL-C) and HDL cholesterol (HDL-C), systolic and diastolic blood pressure and anthropometric factors were assessed at baseline and at the end of the trial.
RESULTS


The results of intervention on 62 patients showed that weight, BMI, and conicity index increased in both groups, but this was significant only in the placebo group (p < 0.001). Waist and hip circumference were decreased in the intervention group and increased significantly in the placebo group (p < 0.001). Body fat percent (p = 0.04), LDL-C (p = 0.05) and SBP (p = 0.02) significantly were decreased in the intervention group. The results showed a significant decrease in body fat percent (p = 0.05), hip circumference (p < 0.001), FBS (p = 0.03) and HDL-C (p = 0.03) in the intervention group compared to the placebo.
CONCLUSIONS


Overall, the results of this study demonstrated that the extract of Berberis Integerrima had beneficial effects on metabolic profile and anthropometric indices in RA patients.",2020,"The results showed a significant decrease in body fat percent (p = 0.05), hip circumference (p < 0.001), FBS (p = 0.03) and HDL-C (p = 0.03) in the intervention group compared to the placebo.
","['active rheumatoid arthritis patients', 'RA patients', '70 active RA patients', 'patients with RA']","['placebo', '6 capsules of 500 mg barberry extract or placebo', 'hydroalcoholic extract of Berberis Integerrima']","['hip circumference', 'weight, BMI, and conicity index', 'blood lipids, blood pressure and obesity', 'Serum levels of fasting blood sugar (FBS), triglyceride (TG), LDL cholesterol (LDL-C) and HDL cholesterol (HDL-C), systolic and diastolic blood pressure and anthropometric factors', 'metabolic profile and anthropometric indices', 'anthropometric indices and metabolic profile', 'FBS', 'LDL-C', 'SBP', 'Waist and hip circumference', 'body fat percent']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0873066', 'cui_str': 'Barberry Extract'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0949843', 'cui_str': 'Barberry'}]","[{'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",70.0,0.376301,"The results showed a significant decrease in body fat percent (p = 0.05), hip circumference (p < 0.001), FBS (p = 0.03) and HDL-C (p = 0.03) in the intervention group compared to the placebo.
","[{'ForeName': 'Naheed', 'Initials': 'N', 'LastName': 'Aryaeian', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: aryaeian.n@iums.ac.ir.'}, {'ForeName': 'Sara Khorshidi', 'Initials': 'SK', 'LastName': 'Sedehi', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: Khorshidi.nutritionist@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Khorshidi', 'Affiliation': ""Student Research Committee, Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran; Pediatric Gastroenterology, Hepatology and Nutrition Research Center, Research Institute for Children Health, Mofid Children's Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Khorshidi.2065@gmail.com.""}, {'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Zarezadeh', 'Affiliation': 'Department of Clinical Nutrition, Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Zarezadehm@tbzmed.ac.ir.'}, {'ForeName': 'AghaFatemeh', 'Initials': 'A', 'LastName': 'Hosseini', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: hosseini_f@tums.ac.ir.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Shahram', 'Affiliation': 'Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: shahramf@tums.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102331']
3317,32444036,A mixed methods evaluation of an individualised yoga therapy intervention for rheumatoid arthritis: Pilot study.,"OBJECTIVES


to explore patients' experiences of an individualised yoga therapy intervention for rheumatoid arthritis (RA), specifically in terms of its acceptability and impact on patient-reported outcomes.
DESIGN


Ten patients took part in a 16 week yoga therapy intervention in a hospital setting, consisting of 10 one-to-one consultations with a yoga therapist followed by two group review sessions. Changes in health (EQ-5D, HADS) were assessed pre- and post-intervention and at 12-month follow-up. In-depth interviews were conducted post-intervention and analysed using thematic analysis.
RESULTS


Attendance of the 1-to-1 sessions was high (98 %) and all participants reported strong commitment to their personalised home practice. There were significant improvements in measures of depression, anxiety, pain, quality of life and general health at post-intervention and 12-months (p < 0.05). In interviews, all but one participant reported positive changes to their symptoms and several reported reductions in their medication and broader benefits such as improved sleep, mood and energy, enabling re-engagement with life. The personally tailored nature of the practice and perceived benefits were key motivational factors. Particular value was placed on the therapeutic function of the consultation and provision of tools to manage stress and build resilience.
CONCLUSION


This yoga therapy intervention was positively received by patients with RA, with high levels of adherence to both the treatments and tailored home practice. The findings suggest that yoga therapy has potential as an adjunct therapy to improve RA symptoms, increase self-care behaviours and manage stress and negative affect such as anxiety. A larger multi-centre study is therefore warranted.",2020,"There were significant improvements in measures of depression, anxiety, pain, quality of life and general health at post-intervention and 12-months (p < 0.05).","['Ten patients took part in a 16 week yoga therapy intervention in a hospital setting, consisting of 10 one-to-one consultations with a yoga therapist followed by two group review sessions', 'rheumatoid arthritis']",['individualised yoga therapy intervention'],"['measures of depression, anxiety, pain, quality of life and general health', 'RA symptoms, increase self-care behaviours', 'Changes in health (EQ-5D, HADS', 'improved sleep, mood and energy, enabling re-engagement with life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",10.0,0.0399396,"There were significant improvements in measures of depression, anxiety, pain, quality of life and general health at post-intervention and 12-months (p < 0.05).","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Cartwright', 'Affiliation': 'University of Westminster, London, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Cahill', 'Affiliation': 'University of Westminster, London, UK.'}, {'ForeName': 'Vidhi', 'Initials': 'V', 'LastName': 'Sadana', 'Affiliation': 'Rheumatology Unit, Central Middlesex Hospital, London, UK. Electronic address: Vidhi.sohdi@nhs.net.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102339']
3318,32444038,The effect of Benson's relaxation response on sleep quality and anorexia in cancer patients undergoing chemotherapy: A randomized controlled trial.,"BACKGROUND AND OBJECTIVES


Patients with cancer experience many side effects due to its nature and usual treatments. Sleep disorders and anorexia are the most commonly reported symptoms in cancer patients undergoing chemotherapy. The present study aimed to investigate the effect of Benson's Relaxation Response (BRR) on sleep quality and anorexia in cancer patients undergoing chemotherapy.
METHODOLOGY AND PARTICIPANTS


In the present clinical trial, a total of 84 patients were enrolled and randomly divided into two groups of experimental and control. Benson's relaxation response was administered to the experimental group twice a day over 5 consecutive days. Data was collected using St. Mary's Hospital Sleep Questionnaire (SMHSQ) and anorexia questionnaire with Visual Analog Scale (VAS).
RESULTS


The results of our study showed a significant improvement in the sleep quality in the experimental group at 24 (p = 0.02) and 48 (p = 0.001) hours after the intervention compared to the control group. Benson's relaxation response (BRR) also had a significant effect on the anorexia in the experimental group at 24 (7.5 ± 1.6) and 48 (6.9 ± 2.1) hours after the intervention compared to the control group. No side effects were reported during the study and follow-up period.
CONCLUSION


Benson's relaxation response as a complementary method may improve sleep quality and anorexia in cancer patients undergoing chemotherapy. Further studies with greater sample size and longer follow-up period are needed to confirm the current findings.",2020,Benson's relaxation response (BRR) also had a significant effect on the anorexia in the experimental group at 24 (7.5 ± 1.6) and 48 (6.9 ± 2.1) hours after the intervention compared to the control group.,"['84 patients', 'Patients with cancer experience', 'cancer patients undergoing chemotherapy']","[""Benson's Relaxation Response (BRR"", ""Benson's relaxation response""]","['sleep quality and anorexia', 'Sleep disorders and anorexia', 'anorexia', ""St. Mary's Hospital Sleep Questionnaire (SMHSQ) and anorexia questionnaire with Visual Analog Scale (VAS"", 'relaxation response (BRR', 'sleep quality', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",84.0,0.027634,Benson's relaxation response (BRR) also had a significant effect on the anorexia in the experimental group at 24 (7.5 ± 1.6) and 48 (6.9 ± 2.1) hours after the intervention compared to the control group.,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Harorani', 'Affiliation': 'Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran; Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Arak, Iran. Electronic address: m.harorani@yahoo.com.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Davodabady', 'Affiliation': 'Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran; Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Arak, Iran. Electronic address: F_davodabady@arakmu.ac.ir.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Farahani', 'Affiliation': 'Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran. Electronic address: z.f.h.nursing@gmail.com.'}, {'ForeName': 'Ali Khanmohamadi', 'Initials': 'AK', 'LastName': 'Hezave', 'Affiliation': 'Student Research Committee, Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran. Electronic address: alikhan.nurse@gmail.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rafiei', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: f.rafiei87@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102344']
3319,32444040,"Mineral rich algae with pine bark improved pain, physical function and analgesic use in mild-knee joint osteoarthritis, compared to Glucosamine: A randomized controlled pilot trial.","INTRODUCTION


Osteoarthritis (OA) is characterised by synovial joint pain, functional disability and affects ∼13 % of people worldwide, of which ∼16-27 % report Knee-OA (KOA). Glucosamine (Glu) is the most widely used nutraceutical treatment for OA despite a lack of scientific consensus, therefore alternative nutraceutical treatments are required. The aim of this study was to investigate the effect of Lithothamnion species, seawater-derived magnesium and pine bark (Aq + ) on pain, symptoms and improve physical function in symptomatic (sKOA), compared to Glu.
METHODS


358 participants were screened. In a double-blinded crossover pilot-trial, sKOA participant (n = 30) were randomly assigned to either the Glu group (2000 mg day -1 ) or Aq +  (3056 mg day -1 ) for 12 weeks (clinicaltrials.gov:NCT03106584). The Knee Injury and Osteoarthritis Outcome Score was used to assess subjective pain and symptoms. Timed-up-and-Go (TuG) and Six minute walking distance were used to assess functional change and analgesic use was recorded.
RESULTS


Aq +  improved pain, with a large effect (P < 0.01, d' = 0.73, 95 %CI 0.201-1.265) and no change for Glu (d' = 0.38, P = 0.06). Only Aq +  improved pain (P < 0.05) for males (d' = 0.91, 95 %CI 0.162-1.667) and females (d' = 0.55, 95 %CI 0.210-1.299). In females, Aq +  improved TuG by -7.02 % (d' = 0.92, 95 %CI 1.699-0.141) while Glu worsened performance by 4.18 % (P = 0.04). Aq +  reduced analgesia by 71.6 %, compared to Glu (P = 0.02; d' = 0.82, 95 %CI 1.524-0.123). Aq +  was superior to Glu at improving pain, KOOS subscales, physical function and analgesia use in mild-sKOA. Given these data, Aq +  should be considered as a supplementary treatment for early-stage-KOA and may have the potential to reduce use of pain medication, although larger replication studies are required.",2020,"RESULTS


Aq +  improved pain, with a large effect (P < 0.01, d' = 0.73, 95 %CI 0.201-1.265) and no change for Glu (d' = 0.38, P = 0.06).","['participant (n = 30', '358 participants were screened', 'symptomatic (sKOA', 'mild-knee joint osteoarthritis']","['Glucosamine', 'sKOA', 'Mineral rich algae with pine bark', 'Lithothamnion species, seawater-derived magnesium and pine bark (Aq + ', 'Glucosamine (Glu', 'Glu group (2000 mg day -1 ) or Aq ']","['pain, physical function and analgesic use', 'Knee Injury and Osteoarthritis Outcome Score', 'analgesia', 'pain, symptoms and improve physical function', 'pain', 'subjective pain and symptoms', 'TuG', 'pain, KOOS subscales, physical function and analgesia use in mild-sKOA']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0002028', 'cui_str': 'Algae'}, {'cui': 'C0330186', 'cui_str': 'Pinus'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]",30.0,0.219278,"RESULTS


Aq +  improved pain, with a large effect (P < 0.01, d' = 0.73, 95 %CI 0.201-1.265) and no change for Glu (d' = 0.38, P = 0.06).","[{'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Heffernan', 'Affiliation': 'Applied Sports Science Technology and Medicine Research Centre (A-STEM), College of Engineering, Swansea University, Swansea, UK. Electronic address: s.m.heffernan@swansea.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'McCarthy', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland; Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Eustace', 'Affiliation': 'Cappagh National Orthopaedic Hospital, Dublin, Ireland.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'FitzPatrick', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Delahunt', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'De Vito', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102349']
3320,32444250,Variation of faecal calprotectin level within the first three months after bowel resection is predictive of endoscopic postoperative recurrence in Crohn's disease.,"BACKGROUND


Early prediction of postoperative recurrence (POR) remains a major concern in Crohn's disease (CD).
AIMS


To assess serial faecal calprotectin (Fcal) monitoring within the first three months to predict CD endoscopic POR.
METHODS


In a multicenter randomized controlled trial, CD patients received azathioprine 2.5 mg/kg/day with oral curcumin (3 g/day) or placebo. Fcal was measured at baseline, one month (M1) and M3. Endoscopic POR at M6 was defined as Rutgeerts' index ≥ i2b (central reading).
RESULTS


Among the 48 patients included, there was no significant difference of median Fcal levels at baseline (p = 0.15), M1 (p = 0.44) and M3 (p = 0.28) between patients with or without endoscopic POR at M6. Fcal kinetics during the first 3 months after surgery was significantly different between the patients with or without POR at M6 (p = 0.021). The median variation between Fcal level at baseline and M3 (ΔFcal M3-M0) was significantly higher in patients with endoscopic POR compared to those without POR (p = 0.01). ΔFcal M3-M0 >+10% demonstrated the best performances to predict endoscopic POR at M6 (AUC=0.73, sensitivity=64.7%[41.1-82.7], specificity=87.5%[68.0-96.3], negative predictive value=77.8%[57.5-91.4] and positive predictive value=78.6%[49.2-95.3]).
CONCLUSION


Fcal variation within the first three months after ileocolonic resection is a promising predictor of early endoscopic POR in CD patients.",2020,Fcal kinetics during the first 3 months after surgery was significantly different between the patients with or without POR at M6 (p = 0.021).,"[""Crohn's disease (CD"", ""Crohn's disease"", 'CD patients']","['azathioprine 2.5\u202fmg/kg/day with oral curcumin', 'ileocolonic resection', 'placebo']","['faecal calprotectin level', 'median variation between Fcal level at baseline and M3 (ΔFcal M3-M0', 'Fcal kinetics', 'serial faecal calprotectin (Fcal) monitoring', 'Endoscopic POR', 'Fcal', 'median Fcal levels']","[{'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",48.0,0.135478,Fcal kinetics during the first 3 months after surgery was significantly different between the patients with or without POR at M6 (p = 0.021).,"[{'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Boube', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Laharie', 'Affiliation': 'Gastroenterology Department, University Hospital, Bordeaux, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Nancey', 'Affiliation': 'Hospices Civils de Lyon, Lyon-Sud hospital, Gastroenterology, Pierre Benite, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Hebuterne', 'Affiliation': 'Department of Gastroenterology and Clinical Nutrition, CHU of Nice and University of Nice Sophia-Antipolis, Nice, France.'}, {'ForeName': 'Mathurin', 'Initials': 'M', 'LastName': 'Fumery', 'Affiliation': 'Gastroenterology Department, University Hospital, Amiens, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Pariente', 'Affiliation': 'Gastroenterology Department, University Hospital, Lille, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Roblin', 'Affiliation': 'Gastroenterology Department, University Hospital, Saint-Etienne, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Department of Gastroenterology, CHU Nancy Brabois, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Régine', 'Initials': 'R', 'LastName': 'Minet-Quinard', 'Affiliation': 'CHU Clermont-Ferrand, Laboratoire de Biochimie, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'CHU Clermont-Ferrand, DRCI, Unité de Biostatistiques, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Bommelaer', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Buisson', 'Affiliation': ""Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France. Electronic address: a_buisson@hotmail.fr.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.03.020']
3321,32444264,Effect of Pharmacologic Prophylaxis on Venous Thromboembolism After Radical Prostatectomy: The PREVENTER Randomized Clinical Trial.,"BACKGROUND


Direct high-quality evidence is lacking evaluating perioperative pharmacologic prophylaxis (PP) after radical prostatectomy (RP) to prevent venous thromboembolism (VTE) leading to significant practice variation.
OBJECTIVE


To study the impact of in-hospital PP on symptomatic VTE incidence and adverse events after RP at 30 d, with the secondary objective of evaluating overall VTE in a screening subcohort.
DESIGN, SETTING, AND PARTICIPANTS


A prospective, phase 4, single-center, randomized trial of men with prostate cancer undergoing open or robotic-assisted laparoscopic RP was conducted (July 2017-November 2018).
INTERVENTION


PP (subcutaneous heparin) plus routine care versus routine care alone. The screening subcohort was offered lower extremity duplex ultrasound at 30 d.
OUTCOMES MEASUREMENTS AND STATISTICAL ANALYSIS


The primary efficacy outcome was symptomatic VTE incidence (pulmonary embolism [PE] or deep venous thrombosis [DVT]). Primary safety outcomes included the incidence of symptomatic lymphocele, hematoma, or bleeding after surgery. Secondary outcomes were overall VTE, estimated blood loss, total surgical drain output, complications, and surveillance imaging bias. Fisher's exact test and modified Poisson regression were performed.
RESULTS AND LIMITATIONS


A total of 501 patients (75% robotic) were randomized and >99% (500/501) completed follow-up. At second interim analysis (N = 445), the symptomatic VTE rate was 2.3% (four PE + DVT and one DVT) for routine care versus 0.9% (one PE + DVT and one DVT) for PP (relative risk 0.40 [95% confidence interval 0.08-2.03], p = 0.3) meeting a futility threshold for early stopping. In the screening subcohort, the overall VTE rate was 3.3% versus 2.4% (p = 0.7). Results were similar at the final analysis (symptomatic VTE: 2.0% vs 0.8%, p = 0.3; overall VTE: 2.9% vs 2.8%, p = 1). No differences were observed in safety or secondary outcomes. All VTE events (seven symptomatic and three asymptomatic) occurred in patients undergoing pelvic lymph node dissection.
CONCLUSIONS


This study was not able to demonstrate a statistically significant reduction in symptomatic VTE associated with PP. There was no increase in the development of symptomatic lymphoceles, bleeding, or other adverse events. Given that the event rate was lower than powered for, further research is needed among high-risk patients (Caprini score ≥8) or patients receiving pelvic lymph node dissection.
PATIENT SUMMARY


In this report, we randomized patients undergoing radical prostatectomy to perioperative pharmacologic prophylaxis or routine care alone. We found that pharmacologic prophylaxis did not reduce postoperative symptomatic venous thromboembolism significantly for men at routine risk. Importantly, pharmacologic prophylaxis did not increase adverse events, such as formation of lymphoceles or bleeding, and can safely be implemented when indicated for patients with risk factors undergoing radical prostatectomy.",2020,"Importantly, pharmacologic prophylaxis did not increase adverse events, such as formation of lymphoceles or bleeding, and can safely be implemented when indicated for patients with risk factors undergoing radical prostatectomy.","['men with prostate cancer undergoing open or', 'patients undergoing', 'patients with risk factors undergoing radical prostatectomy', '501 patients (75% robotic']","['Radical Prostatectomy', 'robotic-assisted laparoscopic RP', 'radical prostatectomy (RP', 'Pharmacologic Prophylaxis', 'radical prostatectomy to perioperative pharmacologic prophylaxis or routine care alone', 'PP (subcutaneous heparin) plus routine care versus routine care alone']","['overall VTE rate', 'symptomatic VTE rate', 'incidence of symptomatic lymphocele, hematoma, or bleeding after surgery', 'postoperative symptomatic venous thromboembolism', 'development of symptomatic lymphoceles, bleeding, or other adverse events', 'adverse events', 'symptomatic VTE incidence (pulmonary embolism [PE] or deep venous thrombosis [DVT', 'formation of lymphoceles or bleeding', 'Venous Thromboembolism', 'overall VTE, estimated blood loss, total surgical drain output, complications, and surveillance imaging bias']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2607832', 'cui_str': 'Surgical drain'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]",501.0,0.14869,"Importantly, pharmacologic prophylaxis did not increase adverse events, such as formation of lymphoceles or bleeding, and can safely be implemented when indicated for patients with risk factors undergoing radical prostatectomy.","[{'ForeName': 'Hiten D', 'Initials': 'HD', 'LastName': 'Patel', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: hitenpatel@jhmi.edu.'}, {'ForeName': 'Farzana A', 'Initials': 'FA', 'LastName': 'Faisal', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Trock', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Joice', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Zeyad R', 'Initials': 'ZR', 'LastName': 'Schwen', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phillip M', 'Initials': 'PM', 'LastName': 'Pierorazio', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Johnson', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Trinity J', 'Initials': 'TJ', 'LastName': 'Bivalacqua', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Misop', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gorin', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'H Ballentine', 'Initials': 'HB', 'LastName': 'Carter', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Partin', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Pavlovich', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mohamad E', 'Initials': 'ME', 'LastName': 'Allaf', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",European urology,['10.1016/j.eururo.2020.05.001']
3322,32444296,Intradermal sterile water injection versus diclofenac sodium in acute renal colic pain: A randomized controlled trial.,"OBJECTIVES


We aimed to evaluate the efficacy of intracutaneous sterile water injection (ISWI) to relieve the pain of acute renal colic compared with diclofenac and placebo.
METHODS


The study included 150 patients presented to the Emergency Department with renal colic randomized into 3 groups: control group received intracutaneous injections of 0.5 cm 3  isotonic saline in the flank, group A received intracutaneous injections of 0.5 cm 3  ISWI in the flank, and group B received an intramuscular injection of 75 mg Diclofenac in the gluteal region. The severity of the pain was assessed by a visual analogue scale system at baseline and 30, 45 min, and 60 min after injections. Subjects with inadequate pain relief at 1 h received rescue analgesia.
RESULTS


The mean baseline pain score was 9.6 ± 0.61 in the ISWI group, 9.72 ± 0.64 in the diclofenac group and 9.26 ± 0.89 in the control group. The mean pain score at 30 min of the control group was reduced to 6.9 ± 1.56. This mean at 30 min after ISWI and diclofenac injections were reduced to 1.98 ± 1.41 and 1.88 ± 1.19 respectively. The mean of pain sore of the ISWI and diclofenac group at 45 and 60 min was constant. Rescue analgesics at 1 h were required by 47 patients receiving the saline injection and by 4 patients and by 7 patients receiving ISWI and diclofenac injection respectively.
CONCLUSIONS


ISWI and diclofenac were equally effective for the pain relief of acute renal colic.",2020,"Rescue analgesics at 1 h were required by 47 patients receiving the saline injection and by 4 patients and by 7 patients receiving ISWI and diclofenac injection respectively.
","['acute renal colic pain', 'Subjects with inadequate pain relief at 1\xa0h received rescue analgesia', '150 patients presented to the Emergency Department with renal colic randomized into 3 groups']","['Intradermal sterile water injection versus diclofenac sodium', 'control group received intracutaneous injections of 0.5\xa0cm 3  isotonic saline in the flank, group A received intracutaneous injections of 0.5\xa0cm 3  ISWI in the flank, and group B received an intramuscular injection of 75\xa0mg Diclofenac', 'diclofenac injection respectively', 'intracutaneous sterile water injection (ISWI', 'diclofenac', 'diclofenac and placebo', 'ISWI and diclofenac']","['mean of pain sore', 'severity of the pain', 'visual analogue scale system', 'pain relief of acute renal colic', 'mean pain score', 'mean baseline pain score', 'Rescue analgesics']","[{'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1708484', 'cui_str': 'Inadequate pain relief'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C1163679', 'cui_str': 'Water 1 g/mL solution for injection'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0230171', 'cui_str': 'Structure of lateral region of abdomen'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C4291486', 'cui_str': 'Diclofenac Injection [Dyloject]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",150.0,0.0931731,"Rescue analgesics at 1 h were required by 47 patients receiving the saline injection and by 4 patients and by 7 patients receiving ISWI and diclofenac injection respectively.
","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Moussa', 'Affiliation': 'Head of Urology Department, Zahraa Hospital, University Medical Center, Lebanese University, Beirut, Lebanon.'}, {'ForeName': 'Athanasios G', 'Initials': 'AG', 'LastName': 'Papatsoris', 'Affiliation': '2nd Department of Urology, School of Medicine, Sismanoglio Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Mohamed Abou', 'Initials': 'MA', 'LastName': 'Chakra', 'Affiliation': 'Faculty of Medical Sciences, Department of Urology, Lebanese University, Beirut, Lebanon. Electronic address: mohamedabouchakra@hotmail.com.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.04.079']
3323,32444306,"Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST study.","BACKGROUND


In the LIBERTY ASTHMA QUEST (ClinicalTrials.gov: NCT02414854) study, dupilumab 200 mg and 300 mg every 2 weeks vs matched-volume placebo reduced severe asthma exacerbations and improved lung function (FEV 1 ), asthma control, and quality of life in patients with uncontrolled, moderate-to-severe asthma (N = 1902). Here, we examine the safety and efficacy of dupilumab in the subpopulation of Japanese patients who participated in QUEST (n = 114; 6%).
METHODS


Endpoints assessed were annualized severe exacerbation rates and the effect of treatment over the 52-week treatment period on FEV 1 , asthma control, asthma-related quality of life, and markers of type 2 inflammation.
RESULTS


In Japanese patients, dupilumab 200 and 300 mg every 2 weeks vs matched placebo reduced severe asthma exacerbation rates by 44% (P = 0.33) and 75% (P = 0.03), respectively, and improved FEV 1  at Week 12 by 0.20 L (P = 0.05) and 0.17 L (P = 0.12). FEV 1  improvements were rapid (by Week 2) and sustained throughout treatment. Significant and/or numerical improvements vs placebo in asthma control and quality of life were also observed throughout treatment. For each endpoint, greater efficacy was observed in patients with elevated baseline levels of type 2 inflammatory biomarkers (blood eosinophils or FeNO). Dupilumab treatment significantly reduced levels of FeNO and total IgE, but not blood eosinophils.
CONCLUSIONS


In this subanalysis of QUEST, the efficacy and safety of dupilumab in Japanese patients was comparable to that observed in the overall intention-to-treat population, suggesting no variability in efficacy on the basis of Japanese ethnicity. (Funded by Sanofi and Regeneron Pharmaceuticals, Inc.; ClinicalTrials.gov number: NCT02414854).",2020,"reduced severe asthma exacerbations and improved lung function (FEV 1 ), asthma control, and quality of life in patients with uncontrolled, moderate-to-severe asthma (N = 1902).","['Japanese patients who participated in QUEST (n\xa0=\xa0114; 6', 'Japanese patients with uncontrolled, moderate-to-severe asthma', 'Japanese patients']","['dupilumab', 'placebo']","['annualized severe exacerbation rates', 'Dupilumab efficacy and safety', 'severe asthma exacerbation rates', 'FEV 1 , asthma control, asthma-related quality of life, and markers of type 2 inflammation', 'levels of FeNO and total IgE', 'efficacy and safety', 'safety and efficacy', 'asthma control and quality of life', 'reduced severe asthma exacerbations and improved lung function (FEV 1 ), asthma control, and quality of life']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.10339,"reduced severe asthma exacerbations and improved lung function (FEV 1 ), asthma control, and quality of life in patients with uncontrolled, moderate-to-severe asthma (N = 1902).","[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Tohda', 'Affiliation': 'Kindai University Hospital, Osaka, Japan. Electronic address: tohda@med.kindai.ac.jp.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Yokohama City Minato Red Cross Hospital, Yokohama City, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Fujisawa', 'Affiliation': 'Allergy Center, Mie National Hospital, Tsu, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Ebisawa', 'Affiliation': 'Department of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization, Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Arima', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Miyata', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Rice', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Yamo', 'Initials': 'Y', 'LastName': 'Deniz', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rowe', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Naimish', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Teper', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}]",Allergology international : official journal of the Japanese Society of Allergology,['10.1016/j.alit.2020.04.002']
3324,32438785,Effect of a physical education-based fitness intermittent teaching unit on high school students' cardiorespiratory fitness: a cluster-randomized controlled trial.,"BACKGROUND


The aim of this study was to compare the effect of the intermittent and traditional physical fitness-based teaching units on cardiorespiratory fitness and physical activity levels in high school students during Physical Education sessions.
METHODS


One hundred and three high school students (Mage=13.6±0.7) from six classes, balanced by grade, were cluster-randomly assigned into traditional (TG), intermittent (IG), and control (CG) groups. The TG performed a fitness teaching unit twice a week for nine weeks (35-40 minutes of the main part of each session). The IG worked during the first half of the sessions' main part (18-20 minutes) similarly to the TG, and during the second half they worked on technical-tactical aspects of invasion sports. Students' cardiorespiratory fitness was measured at the beginning and at the end of the teaching unit. Physical activity levels were measured objectively through a heart rate monitor and subjectively by a self-reported scale during Physical Education sessions.
RESULTS


Both traditional and intermittent teaching units developed students' cardiorespiratory fitness levels (Δ post-pre-intervention: TG, M∆=19.8, SE=9.4; IG, M∆=16.6, SE=7.7); P<0.01). Additionally, both TG (M=86.2, SE=9.9) and IG (M=90.9, SE=7.6) had higher physical activity levels than the CG (M=76.3, SE=13.5) (P<0.05). However, no differences in physical activity levels were found between the IG and TG (P>0.05).
CONCLUSIONS


The intermittent teaching unit allowed the simultaneous development of cardiorespiratory fitness and another curricular objective in the same Physical Education sessions.",2020,"Both traditional and intermittent teaching units developed students' cardiorespiratory fitness levels (Δ post-pre-intervention: TG, M∆=19.8, SE=9.4; IG, M∆=16.6, SE=7.7); P<0.01).","[""high school students' cardiorespiratory fitness"", 'high school students during Physical Education sessions', 'One hundred and three high school students (Mage=13.6±0.7) from six classes, balanced by grade, were cluster-randomly assigned into traditional (TG), intermittent (IG), and control (CG) groups']","['intermittent and traditional physical fitness-based teaching units', 'physical education-based fitness intermittent teaching unit']","[""students' cardiorespiratory fitness levels"", 'cardiorespiratory fitness and physical activity levels', ""Students' cardiorespiratory fitness"", 'Physical activity levels', 'physical activity levels']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",103.0,0.0156922,"Both traditional and intermittent teaching units developed students' cardiorespiratory fitness levels (Δ post-pre-intervention: TG, M∆=19.8, SE=9.4; IG, M∆=16.6, SE=7.7); P<0.01).","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Guijarro-Romero', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, Granada, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mayorga-Vega', 'Affiliation': 'Department of Didactics of Musical, Plastic and Corporal Expression, University of Jaen, Jaen, Spain - dmayorgavega@gmail.com.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Casado-Robles', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, Granada, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Viciana', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, Granada, Spain.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10328-1']
3325,32438787,"The effects of straight and alternating sets on volume load, training efficiency, and metabolic response in grapplers.","BACKGROUND


The importance of strength in Brazilian jiu-jitsu (BJJ) has inspired several recommendations of resistance training (RT) in BJJ athletes, yet little is known about their responses to different RT approaches. Thus, we aimed to investigate volume, efficiency, and fatigue responses in two popular RT protocols.
METHODS


In a randomized crossover design, 12 male BJJ athletes (mean age: 24.5±3.1 years; height: 175±5 cm; body mass: 77.1±12.9 kg; body fat: 14.3±5.7%; BMI: 24.8±3.0) completed two separate RT protocols consisting of the same exercises performed either as straight sets (TRAD) or alternating sets (AST) for three sets to failure with a previously established 10-repetition maximum (10RM) load. Maximal number of repetitions (MNR), training duration, volume load (VL), and training efficiency (TE = VL/time), rating of perceived exertion (RPE), and blood lactate concentration (LAC) were assessed in each protocol.
RESULTS


MNR decreased steadily from first to last sets for all exercises, with no difference between protocols (P>0.05), resulting in the same VL. The shorter duration of AST resulted in increased TE (P<0.001), which was accompanied by higher RPE (P<0.001) and LAC (P<0.05), as well as higher session perceived load (P<0.01).
CONCLUSIONS


Given the role of VL as a driver of RT adaptations, both approaches may be suitable for improvements in strength and hypertrophy. The distinct differences in duration and metabolic response should be considered when implementing RT alongside regular sport training.",2020,"RESULTS


MNR decreased steadily from first to last sets for all exercises, with no difference between protocols (P>0.05), resulting in the same VL.","['grapplers', 'Brazilian jiu-jitsu (BJJ', '12 male BJJ athletes (mean age: 24.5±3.1 years; height: 175±5 cm; body mass: 77.1±12.9 kg; body fat: 14.3±5.7%; BMI: 24.8±3.0) completed two separate RT protocols consisting of the']",['same exercises performed either as straight sets (TRAD) or alternating sets (AST'],"['shorter duration of AST', 'volume load, training efficiency, and metabolic response', 'volume, efficiency, and fatigue responses', 'Maximal number of repetitions (MNR), training duration, volume load (VL), and training efficiency (TE = VL/time), rating of perceived exertion (RPE), and blood lactate concentration (LAC', 'duration and metabolic response']","[{'cui': 'C0336959', 'cui_str': 'Jiu-jitsu'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",12.0,0.0178236,"RESULTS


MNR decreased steadily from first to last sets for all exercises, with no difference between protocols (P>0.05), resulting in the same VL.","[{'ForeName': 'Wesley R', 'Initials': 'WR', 'LastName': 'Belo', 'Affiliation': 'School of Physical Education and Sports, Physical Education Postgraduate Program, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Øvretveit', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway - karsten.ovretveit@ntnu.no.'}, {'ForeName': 'Belmiro F', 'Initials': 'BF', 'LastName': 'De Salles', 'Affiliation': 'School of Physical Education and Sports, Physical Education Postgraduate Program, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Luiz G', 'Initials': 'LG', 'LastName': 'Dos Santos', 'Affiliation': 'School of Physical Education and Sports, Physical Education Postgraduate Program, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Fabrício M', 'Initials': 'FM', 'LastName': 'Ribeiro', 'Affiliation': 'School of Physical Education and Sports, Physical Education Postgraduate Program, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Ingrid B', 'Initials': 'IB', 'LastName': 'Dias', 'Affiliation': 'School of Physical Education and Sports, Physical Education Postgraduate Program, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Simão', 'Affiliation': 'School of Physical Education and Sports, Physical Education Postgraduate Program, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10490-0']
3326,32442355,Attention control therapy for acute stress disorder: A randomized controlled trial.,"BACKGROUND


A subset of people exposed to traumatic events develop acute stress disorder (ASD), and approximately half of people with ASD develop posttraumatic stress disorder (PTSD). This randomized controlled trial examined the efficacy of internet-delivered attention control therapy (ACT), previously shown to reduce PTSD symptoms, as an adjuvant to treatment as usual in the community for patients with ASD.
METHODS


About 119 participants with ASD were randomly assigned to ACT or treatment as usual in the community within the first month following their traumatic event. PTSD symptoms and attention patterns were measured.
RESULTS


A significant reduction in stress-related symptoms was noted across participants with no difference between the two groups. Approximately half of the participants developed PTSD 2 months after the trauma. High attention bias variability was associated with elevated PTSD symptoms. However, attention bias variability did not change due to the therapy sessions.
CONCLUSIONS


Internet-delivered ACT was no more effective in reducing risk for PTSD in participants with ASD than treatment as usual in the community. Although elevated attention bias variability was detected in the patients with ASD, ACT failed to engage this cognitive target. Finally, ACT-based prevention research should proceed with caution given the possibility that this intervention might be associated with symptom worsening as indexed by the Clinical Global Impression scale.",2020,"CONCLUSIONS


Internet-delivered ACT was no more effective in reducing risk for PTSD in participants with ASD than treatment as usual in the community.","['people with ASD develop posttraumatic stress disorder (PTSD', '119 participants with ASD', 'acute stress disorder', 'patients with ASD']","['internet-delivered attention control therapy (ACT', 'ACT', 'Attention control therapy']","['stress-related symptoms', 'risk for PTSD', 'PTSD symptoms and attention patterns']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0236816', 'cui_str': 'Acute stress disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",119.0,0.177213,"CONCLUSIONS


Internet-delivered ACT was no more effective in reducing risk for PTSD in participants with ASD than treatment as usual in the community.","[{'ForeName': 'Adva', 'Initials': 'A', 'LastName': 'Segal', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Wald', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Pine', 'Affiliation': 'Section on Development and Affective Neuroscience, Emotion and Development Branch, Intramural Research Program, National Institutes of Mental Health, Bethesda, Maryland.'}, {'ForeName': 'Pinchas', 'Initials': 'P', 'LastName': 'Halpern', 'Affiliation': 'Department of Emergency Medicine, The Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Bar-Haim', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}]",Depression and anxiety,['10.1002/da.23040']
3327,32442384,Cycling reduces blood glucose excursions after an oral glucose tolerance test in pregnant women: A randomized crossover trial.,"The aim of this study was to evaluate the effect of an acute bout of cycling immediately after oral glucose intake on glucose metabolism in pregnant women at risk for gestational diabetes mellitus (GDM). Fifteen pregnant women with BMI ≥ 27kg/m2 were enrolled in a randomized crossover controlled study and underwent two oral glucose tolerance tests (OGTTs) ingesting 75-gram glucose followed by either 20 minutes of stationary cycling at moderate intensity (65-75% maximal heart rate) or rest. Using continuous glucose monitors, glucose was measured up to 48 hours after the OGTT. Glucose, insulin and C-peptide was determined at baseline and after one and two hours. One hour after glucose intake, mean blood glucose was significantly lower after cycling compared to rest (p=0.002). Similarly, mean glucose peak level was significantly lower after cycling than after rest (p=0.039). Lower levels of insulin and C-peptide were observed after one hour (p<0.01). Differences in glucose measurements after two hours and up to 48 hours were not statistically different. We found that twenty minutes of cycling at moderate intensity after glucose intake reduced blood glucose excursions in pregnant women at risk for GDM. Novelty Bullets: • In pregnant women, we found that cycling after glucose intake resulted in significantly lower glucose levels compared to rest. • The exercise intervention studied is feasible for pregnant women and could be readily used to reduce glucose excursions.",2020,"One hour after glucose intake, mean blood glucose was significantly lower after cycling compared to rest (p=0.002).","['pregnant women at risk for GDM. Novelty Bullets: •', 'pregnant women at risk for gestational diabetes mellitus (GDM', 'Fifteen pregnant women with BMI ≥ 27kg/m2', 'pregnant women']","['oral glucose tolerance tests (OGTTs) ingesting 75-gram glucose followed by either 20 minutes of stationary cycling', 'exercise intervention', 'oral glucose intake']","['Glucose, insulin and C-peptide', 'blood glucose excursions', 'glucose measurements', 'glucose levels', 'mean blood glucose', 'glucose metabolism', 'mean glucose peak level', 'Lower levels of insulin and C-peptide']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0336699', 'cui_str': 'Bullet'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439835', 'cui_str': 'Stationary'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556133', 'cui_str': 'Glucose intake'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",15.0,0.0364558,"One hour after glucose intake, mean blood glucose was significantly lower after cycling compared to rest (p=0.002).","[{'ForeName': 'Mette Bisgaard', 'Initials': 'MB', 'LastName': 'Andersen', 'Affiliation': 'Aarhus University Hospital, 11297, Obstetrics and Gynecology, Aarhus N, Denmark , 8200 ; metbisan@rm.dk.'}, {'ForeName': 'Per Glud', 'Initials': 'PG', 'LastName': 'Ovesen', 'Affiliation': 'Aarhus University Hospital, 11297, Obstetrics and Gynecology, Aarhus N, Denmark ; perovese@rm.dk.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Daugaard', 'Affiliation': 'Aarhus University Hospital, 11297, Obstetrics and Gynecology, Aarhus N, Denmark ; merete.daugaard@skejby.rm.dk.'}, {'ForeName': 'Eva Bjerre', 'Initials': 'EB', 'LastName': 'Ostenfeld', 'Affiliation': 'Aarhus University Hospital, 11297, Obstetrics and Gynecology, Aarhus N, Denmark ; dr.ostenfeld@rm.dk.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Fuglsang', 'Affiliation': 'Aarhus University Hospital, 11297, Obstetrics and Gynecology, Aarhus N, Denmark ; jens.fuglsang@skejby.rm.dk.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0020']
3328,32442523,"Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: an open-label, randomised, controlled trial.","BACKGROUND


The globally synchronised introduction of inactivated poliovirus vaccine (IPV) and replacement of trivalent oral poliovirus vaccine (OPV) with bivalent OPV (bOPV) were successfully implemented in China's routine immunisation programme in May, 2016. In response to the global shortage of Salk-strain IPV, Sabin-strain IPV production was encouraged to develop and use in low-income and middle-income countries. We assessed the immunogenicity of the current routine poliovirus vaccination schedule in China and compared it with alternative schedules that use Sabin-strain IPV (sIPV) and bOPV.
METHODS


This open-label, randomised, controlled trial recruited healthy infants aged 60-75 days from two centres in Zhejiang, China. Eligible infants were full-term, due for their first polio vaccination, weighed more than 2·5 kg at birth, were healthy on physical examination with no obvious medical conditions, and had no contraindications to vaccination. Infants were randomly assigned (1:1:1) using permuted block randomisation (block size of 12) to one of three polio vaccination schedules, with the first, second, and third doses given at ages 2 months, 3 months, and 4 months, respectively: sIPV-bOPV-bOPV (1sIPV+2bOPV group; current regimen), sIPV-sIPV-bOPV (2sIPV+1bOPV group), or sIPV-sIPV-sIPV (3sIPV group). The primary endpoint was the proportion of infants with seroconversion to each of the three poliovirus serotypes 1 month after the third dose. Serious and medically important adverse events were monitored for up to 30 days after each vaccination. We assessed immunity in the per-protocol population (all children who completed all three vaccinations and had pre-vaccination and post-vaccination laboratory data) and safety in all children who received at least one dose of study vaccine. This trial is registered with Clinicaltrials.gov, NCT03147560.
RESULTS


Between May 1, 2016, and Dec 1, 2017, we enrolled and randomly assigned 528 eligible infants to one of the three treatment groups (176 in each group); 473 infants (158 in the 1sIPV+2bOPV group, 152 in the 2sIPV+1bOPV group, and 163 in the 3sIPV group) were included in the per-protocol population. 100% seroconversion against poliovirus types 1 and 3 was observed in all three groups. Infants who received an immunisation schedule containing bOPV had significantly higher antibody titres against poliovirus types 1 and 3 than did the sIPV-only group (2048 in all three treatment groups; p<0·0001). Seroconversion against type 2 poliovirus was observed in 98 (62%) infants in the 1sIPV+2bOPV group, 145 (95%) infants in the 2sIPV+1bOPV group, and 161 (99%) infants in the 3sIPV group. No serious adverse events occurred during the study; 14 minor, transient adverse events were observed, with no significant differences across study groups.
INTERPRETATION


All three study schedules were well tolerated and highly immunogenic against poliovirus types 1 and 3. Schedules containing two or three sIPV doses had higher seroconversion rates against poliovirus type 2 than did the schedule with a single dose of sIPV. Our findings support inclusion of two sIPV doses in the routine poliovirus vaccination schedule in China to provide better protection against poliovirus type 2 than provided by the current regimen.
FUNDING


Chinese Center for Disease Control and Prevention and China National Biotec Group Company.",2020,Infants who received an immunisation schedule containing bOPV had significantly higher antibody titres against poliovirus types 1 and 3 than did the sIPV-only group (2048 in all three treatment groups; p<0·0001).,"['healthy infants aged 60-75 days from two centres in Zhejiang, China', 'per-protocol population (all children who completed all three vaccinations and had pre-vaccination and post-vaccination laboratory data) and safety in all children who received at least one dose of study vaccine', 'Eligible infants were full-term, due for their first polio vaccination, weighed more than 2·5 kg at birth, were healthy on physical examination with no obvious medical conditions, and had no contraindications to vaccination', '528 eligible infants to one of the three treatment groups (176 in each group); 473 infants (158 in the 1sIPV+2bOPV group, 152 in the 2sIPV+1bOPV group, and 163 in the 3sIPV group) were included in the per-protocol population', 'Zhejiang, China']","['inactivated poliovirus vaccine (IPV) and replacement of trivalent oral poliovirus vaccine (OPV) with bivalent OPV (bOPV', 'sIPV-bOPV-bOPV (1sIPV+2bOPV group; current regimen), sIPV-sIPV-bOPV (2sIPV+1bOPV group), or sIPV-sIPV-sIPV (3sIPV group', 'Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine']","['Seroconversion against type 2 poliovirus', 'seroconversion rates', 'serious adverse events', 'transient adverse events', 'antibody titres against poliovirus types', 'proportion of infants with seroconversion', 'Immunogenicity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0419714', 'cui_str': 'First polio vaccination'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0852650', 'cui_str': 'Contraindication to vaccination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0206435', 'cui_str': 'Human poliovirus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",528.0,0.155858,Infants who received an immunisation schedule containing bOPV had significantly higher antibody titres against poliovirus types 1 and 3 than did the sIPV-only group (2048 in all three treatment groups; p<0·0001).,"[{'ForeName': 'Hanqing', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Chenyan', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Immunisation Programme Department, Hangzhou Municipal Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Immunisation Programme Department, Quzhou Municipal Center for Disease Control and Prevention, Quzhou, Zhejiang, China.'}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Immunisation Programme Department, Chun'an County Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Zhongbing', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Immunisation Programme Department, Longyou County Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Shuyun', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wen', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'An', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China. Electronic address: zhpchen@cdc.zj.cn.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: wanghq@chinacdc.cn.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30738-8']
3329,32442607,1-Year Patient Survival Correlates with Surgeon Volume following Elective Open Abdominal Aortic Surgery.,"INTRODUCTION


and Objectives: Volume-outcome relationships in surgery have been well established. Recent studies have shown that high-volume surgeons provide improved outcomes performing open abdominal aneurysm repairs. The hypothesis of this study is that high-volume surgeons provide superior short and midterm outcomes performing elective open aortic operations when compared to low-volume surgeons.
METHODS


We evaluated patients undergoing elective open abdominal aortic aneurism repair (AAA), aorto-femoral bypass (AFB), and aorto-mesenteric bypass (AMB) by board certified vascular surgeons using The New York Statewide Planning and Research Cooperative System database from 2002 to 2014. The Contal and O'Quigley technique was used to estimate a cut point objectively and provided an estimate of significance. A division using average yearly volumes (averaged over 3 years) of >/= 7 cases and < 7 case per year returned the highest Q statistic and this grouping was used to classify high and low provider volume groups. Rates of complications during index hospitalization, length of stay, 30-day survival, 90-day survival, 1-year survival and cause of death were analyzed using mixed effect models.
RESULTS


266 board certified vascular surgeons performed 244 AMB, 4,202 AFB, and 6,126 AAA in 118 hospitals over the 13-year period. High volume surgeon's rates of complications during index hospitalization, 30-day survival, 90-day survival, and 1-year survival were superior over low volume surgeons. The Contal and O'Quigley technique returned an estimate of 7 operations per year for optimal survival over 1 year. This cutoff is associated with an adjusted 1-year hazard ratio of 0.687 (p=0.003), a 2.69 percent difference in 1-year all cause survival (p=0.003), a 1.76-day reduction in the mean length of stay at index hospitalization (p<0.001). Higher volume surgeons showed a 25.0, 43.4, 42.4, 40.6, and 45.0% reduction in post-operative rates of acute renal failure (p<0.001), hemorrhage (p<0.001), pulmonary failure (p<0.001), sepsis (p<0.001) and venous thromboembolism (p<0.001), respectively. Abdominal abscess, acute renal failure, hemorrhage, myocardial infarction, and sepsis were associated with increased cardiovascular specific mortality after open aortic operations (p<0.001).
CONCLUSIONS


These data demonstrate that high volume surgeons performing elective open aortic operations provide reduced complications, and improved short and mid-term survival, when compared to low-volume surgeons. It also identifies clinical and post-operative variables that are associated with increased cardiovascular specific mortality. These data provide further evidence that elective open abdominal vascular surgery should be centralized to high volume surgeons.",2020,"Abdominal abscess, acute renal failure, hemorrhage, myocardial infarction, and sepsis were associated with increased cardiovascular specific mortality after open aortic operations (p<0.001).
","['patients undergoing elective open abdominal aortic aneurism repair (AAA), aorto-femoral bypass (AFB), and aorto-mesenteric bypass (AMB) by board certified vascular surgeons using The New York Statewide Planning and Research Cooperative System database from 2002 to 2014']",['Elective Open Abdominal Aortic Surgery'],"['Abdominal abscess, acute renal failure, hemorrhage, myocardial infarction, and sepsis', 'hemorrhage (p<0.001), pulmonary failure (p<0.001), sepsis (p<0.001) and venous thromboembolism', 'cardiovascular specific mortality', 'post-operative rates of acute renal failure', '1-year all cause survival', 'Rates of complications during index hospitalization, length of stay, 30-day survival, 90-day survival, 1-year survival and cause of death', '30-day survival, 90-day survival, and 1-year survival', 'mean length of stay at index hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0025474', 'cui_str': 'Mesenteric'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0586909', 'cui_str': 'Vascular surgeon'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0877130', 'cui_str': 'Aortic surgery'}]","[{'cui': 'C0243001', 'cui_str': 'Abdominal abscess'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0948755', 'cui_str': 'Pulmonary failure'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.168845,"Abdominal abscess, acute renal failure, hemorrhage, myocardial infarction, and sepsis were associated with increased cardiovascular specific mortality after open aortic operations (p<0.001).
","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Geiger', 'Affiliation': 'Division of Vascular Surgery, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Aquina', 'Affiliation': 'Surgical Health Outcomes and Research Enterprise (SHORE), University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Esce', 'Affiliation': 'Division of Vascular Surgery, University of Rochester Medical Center, Rochester, New York; Surgical Health Outcomes and Research Enterprise (SHORE), University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Division of Vascular Surgery, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Roan', 'Initials': 'R', 'LastName': 'Glocker', 'Affiliation': 'Division of Vascular Surgery, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Fergal', 'Initials': 'F', 'LastName': 'Fleming', 'Affiliation': 'Surgical Health Outcomes and Research Enterprise (SHORE), University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Iannuzzi', 'Affiliation': 'Division of Vascular Surgery, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stoner', 'Affiliation': 'Division of Vascular Surgery, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Doyle', 'Affiliation': 'Division of Vascular Surgery, University of Rochester Medical Center, Rochester, New York. Electronic address: Adam_Doyle@urmc.rochester.edu.'}]",Journal of vascular surgery,['10.1016/j.jvs.2020.04.509']
3330,32442673,Salivary oxytocin after oxytocin administration: Examining the moderating role of childhood trauma.,"Although oxytocin administration influences behavior, its effects on peripheral oxytocin concentrations are mixed and derived from studies on healthy subjects. Additionally, trauma attenuates the behavioral effects of oxytocin, but it is unknown whether it also influences its effect on peripheral circulation. This study examined whether salivary oxytocin increased after oxytocin administration and whether trauma attenuated this effect. We conducted a randomized, double-blind, placebo-controlled, within-subjects study in 100 male adolescents living in residential youth care facilities. Participants self-administered intranasally 24 IU of oxytocin and placebo (one week later) and provided a saliva sample before and 15 min after administration. Salivary oxytocin increased significantly after oxytocin administration, but this effect might be inflated by exogenous oxytocin reaching the throat. Trauma did not moderate this effect. Our findings suggest that trauma did not attenuate the effect of oxytocin administration on salivary oxytocin, but more robust methodologies are recommended to draw more solid conclusions.",2020,Trauma did not moderate this effect.,"['100 male adolescents living in residential youth care facilities', 'healthy subjects']","['oxytocin', 'salivary oxytocin', 'Salivary oxytocin', 'oxytocin and placebo', 'placebo']","['Salivary oxytocin', 'peripheral oxytocin concentrations']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",100.0,0.442201,Trauma did not moderate this effect.,"[{'ForeName': 'Iro', 'Initials': 'I', 'LastName': 'Fragkaki', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, the Netherlands. Electronic address: i.fragkaki@pwo.ru.nl.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Glennon', 'Affiliation': 'Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Cima', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, the Netherlands.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107903']
3331,32442688,"A commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - An open labeled, randomized controlled trial"" - What is missing for a careful analysis? The importance of considering all the factors involved.",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.102212,,"[{'ForeName': 'Leandro Ryuchi', 'Initials': 'LR', 'LastName': 'Iuamoto', 'Affiliation': 'Department of Surgery, Laboratory of Medical Research 02, Division of Human Structural Topography, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'General and Gastrointestinal (GI) Surgeon, Hospital Das Clínicas, Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil. Electronic address: alberto.meyer@hc.fm.usp.br.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.045']
3332,32443963,Perceptive-cognitive and physical function in pre-frail older adults: exergaming vs traditional multicomponent training.,"Research highlights the benefits of regular traditional multicomponent training in older adults. The potential effect of exergames on perceptive-cognitive and physical function in pre-frail older adults is still little explored. The study aimed to compare the effects of two physical exercise training programs (exergaming vs. traditional multicomponent) on perceptive-cognitive and physical functions of pre-frail older adults. This study was a randomized controlled trial having 66 pre-frail older adults assigned to two groups (Exergames [EG]: n = 32, 70.84 ± 4.53 years; Multicomponent [MG]: n = 34, 70.76 ± 5.60 years). Frailty phenotype, fall history, basic and advanced cognition, perceptual, physical (mobility, gait speed, and balance) and muscle (strength and power) functions were evaluated. Intervention was conducted during12 weeks. The EG and MG groups performed similar exercise routines involving the main lower limb muscle groups required in daily activities. A mixed model ANOVA and effect size (d) revealed that both programs were effective in postponing frailty status, reducing the fear of falling (EG: d=1.65; MG: d=1.40), increasing fall risk awareness (EG: d=2.14; MG: d=1.60), improving cognitive status (EG: d=0.83 to 2.61; MG: d=0.86 to 1.43), muscle (EG: d=0.54; MG: d=0.51 to 0.73) and physical function (EG: d=0.97 to 1.55; MG: d=1.01 to 2.23). The exergame training might be a better alternative to improve cognition, whereas the multicomponent program might be a better option to provide physical function gains.",2020,"A mixed model ANOVA and effect size (d) revealed that both programs were effective in postponing frailty status, reducing the fear of falling (EG: d=1.65; MG: d=1.40), increasing fall risk awareness (EG: d=2.14; MG: d=1.60), improving cognitive status","['older adults', '66 pre-frail older adults assigned to two groups (Exergames [EG]: n = 32, 70.84 ± 4.53 years', 'pre-frail older adults']","['regular traditional multicomponent training', 'Multicomponent [MG', 'traditional multicomponent training', 'physical exercise training programs (exergaming vs. traditional multicomponent']","['Perceptive-cognitive and physical function', 'fall risk awareness', 'perceptive-cognitive and physical function', 'Frailty phenotype, fall history, basic and advanced cognition, perceptual, physical (mobility, gait speed, and balance) and muscle (strength and power) functions', 'cognitive status', 'perceptive-cognitive and physical functions']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",66.0,0.011829,"A mixed model ANOVA and effect size (d) revealed that both programs were effective in postponing frailty status, reducing the fear of falling (EG: d=1.65; MG: d=1.40), increasing fall risk awareness (EG: d=2.14; MG: d=1.60), improving cognitive status","[{'ForeName': 'Natália Boneti', 'Initials': 'NB', 'LastName': 'Moreira', 'Affiliation': 'Universidade Federal do Parana, 28122, Physiotherapy, Av. Cel. Francisco H. dos Santos, 100, Curitiba, Brazil, 81531-980; nbmoreiraa@gmail.com.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Rodacki', 'Affiliation': 'Federal University of Paraná, Physical education, Curitiba, Paraná, Brazil; rodacki@ufpr.br.'}, {'ForeName': 'Sabrine', 'Initials': 'S', 'LastName': 'Costa', 'Affiliation': 'Universidade Federal do Paraná, 28122, Physical Education, Curitiba, Paraná, Brazil; scosta713@gmail.com.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Pitta', 'Affiliation': 'Federal University of Parana, 28122, Rua Coração de Maria, 92- BR 116-Km 95 Jardim Botânico, Curitiba, Brazil, 80215-370; arthur_pitta@yahoo.com.br.'}, {'ForeName': 'Paulo Cesar', 'Initials': 'PC', 'LastName': 'Bento', 'Affiliation': 'Universidade Federal do Paraná, 28122, Physical Education, Avenida República Argentina, Novo Mundo, Curitiba, Paraná, Brazil, 81050001; p.bento063@gmail.com.'}]",Rejuvenation research,['10.1089/rej.2020.2302']
3333,32443977,"The evaluation of Suchana, a large-scale development program to prevent chronic undernutrition in north-eastern Bangladesh.","Evidence of the impact of community-based nutrition programs is uncommon for two main reasons: the lack of untreated controls, and implementation does not account for the evaluation design. Suchana is a large-scale program to prevent malnutrition in children in Sylhet division, Bangladesh by improving the livelihoods and nutrition knowledge of poor and very poor households. Suchana is being implemented in 157 unions, the smallest administrative unit of government, in two districts of Sylhet. Suchana will deliver a package of interventions to poor people in about 40 randomly selected new unions annually over 4 years, until all are covered. All beneficiaries will receive the normal government nutrition services. For evaluation purposes the last 40 unions will act as a control for the first 40 intervention unions. The remaining unions will receive the program but will not take part in the evaluation. A baseline survey was conducted in both intervention and control unions; it will be repeated after 3 years to estimate the impact on the prevalence of stunted children and other indicators. This stepped wedge design has several advantages for both the implementation and evaluation of services, as well as some disadvantages. The units of delivery are randomized, which controls for other influences on outcomes; the program supports government service delivery systems, so it is replicable and scalable; and the program can be improved over time as lessons are learned. The main disadvantages are the difficulty of estimating the impact of each component of the program, and the geographical distribution of unions, which increases program delivery costs. Stepped implementation allows a cluster randomized trial to be achieved within a large-scale poverty alleviation program and phased-in and scaled-up over a period of time. This paper may encourage evaluators to consider how to estimate attributable impact by using stepped implementation, which allows the counterfactual group eventually to be treated.",2020,"Suchana is a large-scale program to prevent malnutrition in children in Sylhet division, Bangladesh by improving the livelihoods and nutrition knowledge of poor and very poor households.","['chronic undernutrition in north-eastern Bangladesh', '157 unions, the smallest administrative unit of government, in two districts of Sylhet']",['community-based nutrition programs'],[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0018104', 'cui_str': 'Government'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0221132,"Suchana is a large-scale program to prevent malnutrition in children in Sylhet division, Bangladesh by improving the livelihoods and nutrition knowledge of poor and very poor households.","[{'ForeName': 'Nuzhat', 'Initials': 'N', 'LastName': 'Choudhury', 'Affiliation': 'Nutrition and Clinical Services Division, icddrb, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh. nuzhat@icddrb.org.'}, {'ForeName': 'Mohammad Jyoti', 'Initials': 'MJ', 'LastName': 'Raihan', 'Affiliation': 'Nutrition and Clinical Services Division, icddrb, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh.'}, {'ForeName': 'S M Tanvir', 'Initials': 'SMT', 'LastName': 'Ahmed', 'Affiliation': 'Save the Children Bangladesh, House CWN (A) 35, Road 43, Gulshan, Dhaka, Bangladesh.'}, {'ForeName': 'Kazi Eliza', 'Initials': 'KE', 'LastName': 'Islam', 'Affiliation': 'Save the Children Bangladesh, House CWN (A) 35, Road 43, Gulshan, Dhaka, Bangladesh.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Self', 'Affiliation': ""Save the Children U.K., 1 St John's Lane, London, EC1M 4AR, UK.""}, {'ForeName': 'Shahed', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Save the Children Bangladesh, House CWN (A) 35, Road 43, Gulshan, Dhaka, Bangladesh.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Schofield', 'Affiliation': ""Save the Children U.K., 1 St John's Lane, London, EC1M 4AR, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': ""Save the Children U.K., 1 St John's Lane, London, EC1M 4AR, UK.""}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division, icddrb, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh.'}]",BMC public health,['10.1186/s12889-020-08769-4']
3334,32443981,"Study protocol: improving cognition in people with progressive multiple sclerosis: a multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx).","BACKGROUND


Cognitive dysfunction affects up to 70% of people with progressive MS (PMS). It can exert a deleterious effect on activities of daily living, employment and relationships. Preliminary evidence suggests that performance can improve with cognitive rehabilitation (CR) and aerobic exercise (EX), but existing data are predominantly from people with relapsing-remitting MS without cognitive impairment. There is therefore a need to investigate whether this is also the case in people with progressive forms of the disease who have objectively identified cognitive impairment. It is hypothesized that CR and EX are effective treatments for people with PMS who have cognitive impairment, in particular processing speed (PS) deficits, and that a combination of these two treatments is more effective than each individual treatment given alone. We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques.
METHODS


This study is a multisite, randomized, double-blinded, sham controlled clinical trial of CR and aerobic exercise. Three hundred and sixty subjects from 11 sites will be randomly assigned into one of four groups: CR plus aerobic exercise; CR plus sham exercise; CR sham plus aerobic exercise and CR sham plus sham exercise. Subjects will participate in the assigned treatments for 12 weeks, twice a week. All subjects will have a cognitive and physical assessment at baseline, 12 weeks and 24 weeks. In an embedded sub-study, approximately 30% of subjects will undergo structural and functional MRI to investigate the neural mechanisms underlying the behavioral response. The primary outcome is the Symbol Digit Modalities Test (SDMT) measuring PS. Secondary outcome measures include: indices of verbal and non-verbal memory, depression, walking speed and a dual cognitive-motor task and MRI.
DISCUSSION


The study is being undertaken in 6 countries (11 centres) in multiple languages (English, Italian, Danish, Dutch); with testing material validated and standardized in these languages. The rationale for this approach is to obtain a robustly powered sample size and to demonstrate that these two interventions can be given effectively in multiple countries and in different languages.
TRIAL REGISTRATION


The trial was registered on September 20th 2018 at www.clinicaltrials.gov having identifier NCT03679468. Registration was performed before recruitment was initiated.",2020,"We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques.
","['people with progressive MS (PMS', 'people with progressive multiple sclerosis', 'Three hundred and sixty subjects from 11 sites', 'people with PMS who have cognitive impairment', '6 countries (11 centres) in multiple languages (English, Italian, Danish, Dutch); with testing material validated and standardized in these languages', 'people with relapsing-remitting MS without cognitive impairment', 'people with progressive forms of the disease who have objectively identified cognitive impairment']","['cognitive rehabilitation and aerobic exercise (COGEx', 'cognitive rehabilitation (CR) and aerobic exercise (EX', 'CR and aerobic exercise', 'CR plus aerobic exercise; CR plus sham exercise; CR sham plus aerobic exercise and CR sham plus sham exercise']","[' indices of verbal and non-verbal memory, depression, walking speed and a dual cognitive-motor task and MRI', 'Symbol Digit Modalities Test (SDMT) measuring PS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}]",,0.510419,"We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques.
","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Feinstein', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Amato', 'Affiliation': 'Department NEUROFARBA, Section Neurosciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Brichetto', 'Affiliation': 'Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Via Operai 40, 16149, Genoa, Italy.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Chataway', 'Affiliation': 'Queen Square MS Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Chiaravalloti', 'Affiliation': 'Kessler Foundation, East Hanover, NJ, USA.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Section for Sport Science, Department of Public Health, Aarhus University, Dalgas Avenue 4, DK-8000, Aarhus, Denmark. dalgas@ph.au.dk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Kessler Foundation, East Hanover, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Filippi', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, and Neurology unit, IRCCS, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Faculty of Health: Medicine, Dentistry and Human Sciences, University of Plymouth, Devon, UK.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Meza', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Inglese', 'Affiliation': 'Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), and Center of Excellence for Biomedical Research, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Maria Assunta', 'Initials': 'MA', 'LastName': 'Rocca', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, and Neurology unit, IRCCS, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Sandroff', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC neurology,['10.1186/s12883-020-01772-7']
3335,32444033,The effect of lavender herbal tea on the anxiety and depression of the elderly: A randomized clinical trial.,"BACKGROUND


The prevalence of depression and anxiety is increasing among the elderly around the world. It is believed that lavender can stabilize the people's mood, so this study was designed to evaluate the effect of lavender on anxiety and depression of the elderly.
METHODS


This study was a single blind clinical trial with a control group. The participants in the study consisted of 60 elderly subjects (30 in each group) who referred to the Health Center of Larestan city in the south of Iran in 2019. The intervention consisted of using 2 g of lavender teabag, which was prescribed to be used 2 times as decoction in the morning and night. The duration of the intervention was 2 weeks. The eligible participants were randomly assigned to the intervention and control groups using balanced block randomization with a block size of ten. The control group did not receive any placebo. Data collection tools in this study included demographic information questionnaire, Beck Depression and Spiel Berger Anxiety Inventory. Chi-square test and independent t-test were used to analyze the data. The significance level was considered 5 %.
RESULTS


The two groups were similar in terms of age, gender, educational level and marital status and there was no significant difference. The mean score of depression in the intervention group before and after drinking lavender herbal tea was 17.80 ± 1.49 and 16.33 ± 1.49, respectively. The mean score of depression between intervention and control groups after drinking herbal tea were 16.33 ± 1.49 and 18.33 ± 1.84, respectively. This indicated the effect of herbal tea on reducing depression (P < 0.001). Also, mean difference of intervention and control groups after drinking herbal tea in terms of depression and anxiety (state and trait) were (-2.00, 95 % CI (-2.86, -1.13)), (-6.40, 95 % CI (-9.43, -3.36)) and (-4.13, 95 % CI (-7.66, -0.60)), respectively.
CONCLUSION


The results of the present study showed that consumption of lavender herbal tea can reduce depression and anxiety scores and since it is inexpensive and accessible, it is suggested to be used as a complementary treatment in reducing anxiety and depression.",2020,"The two groups were similar in terms of age, gender, educational level and marital status and there was no significant difference.","['anxiety and depression of the elderly', '60 elderly subjects (30 in each group) who referred to the Health Center of Larestan city in the south of Iran in 2019']","['placebo', 'herbal tea', 'lavender herbal tea', 'lavender']","['reducing depression', 'mean score of depression', 'demographic information questionnaire, Beck Depression and Spiel Berger Anxiety Inventory', 'depression and anxiety scores', 'depression and anxiety (state and trait']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019233', 'cui_str': 'Herbal tea'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1301808', 'cui_str': 'State'}]",60.0,0.0480723,"The two groups were similar in terms of age, gender, educational level and marital status and there was no significant difference.","[{'ForeName': 'Mohammad-Rafi', 'Initials': 'MR', 'LastName': 'Bazrafshan', 'Affiliation': 'Department of Nursing, School of Nursing, Larestan University of Medical Sciences, Larestan, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Jokar', 'Affiliation': 'Department of Nursing, Khomein University of Medical Sciences, Khomein, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Shokrpour', 'Affiliation': 'English Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Delam', 'Affiliation': 'Student Research Committee, Larestan University of Medical Sciences, Larestan, Iran. Electronic address: hameddelam8@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102393']
3336,32444201,Guided versus freehand acromioplasty during rotator cuff repair. A randomized prospective study.,"INTRODUCTION


There is no consensus on how to perform acromioplasty, particularly regarding the level and extent of bone resection, which depend on scapular and humeral morphologies.
HYPOTHESIS


We aimed to determine whether computer-assisted acromioplasty planning helps surgeons remove impinging bone, reduce unnecessary resections, and improve short-term outcomes of rotator cuff tears (RCR).
PATIENTS AND METHODS


We randomized 64 patients undergoing RCR of full-thickness supraspinatus tears into two groups: 'guided acromioplasty' (GA) and 'freehand acromioplasty' (FA). The pre- and post-operative scapula models were reconstructed using computed-tomography scans to quantify impinging bone removal, unnecessary bone resections, and identify zones of acromial bone removal. All patients were evaluated preoperatively and at 6 months to assess their range of motion (ROM), functional scores and tendon integrity using ultrasound.
RESULTS


The two groups did not differ in demographics, clinical or morphologic characteristics. Compared to FA, GA tended to lower impinging bone removal (55±26% vs. 43±27%, p=0.087) and to increase unnecessary resection of the total bone removed (49±22% vs. 57±27%, p=0.248). GA resulted in significant anterior under-resection, while FA resulted in significant medial over-resection. Clinical outcomes and ROM improved significantly for all patients, except for internal rotation in the GA group. There were no other significant differences between the two groups, neither in terms of post-operative scores nor in terms of clinical net improvements, nor tendon repair integrity.
CONCLUSIONS


This computer-assisted planning for acromioplasty during RCR proved no benefits in terms of bone removal, tendon healing, or clinical outcomes. Nonetheless such planning tools could help less experienced surgeons improve the efficacy of acromioplasty.
LEVEL OF PROOF


I, Randomized controlled trial (Therapeutic study).",2020,"This computer-assisted planning for acromioplasty during RCR proved no benefits in terms of bone removal, tendon healing, or clinical outcomes.",['64 patients undergoing RCR of full-thickness supraspinatus tears into two groups: '],"['Guided versus freehand acromioplasty during rotator cuff repair', 'computer-assisted acromioplasty planning', ""guided acromioplasty' (GA) and 'freehand acromioplasty' (FA""]","['LEVEL OF PROOF', 'ROM', 'clinical net improvements, nor tendon repair integrity', 'range of motion (ROM), functional scores and tendon integrity using ultrasound', 'unnecessary resection of the total bone', 'impinging bone removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0439059', 'cui_str': 'Supraspinatus tear'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0186663', 'cui_str': 'Acromioplasty of shoulder'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0556981', 'cui_str': '% proof'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0565350', 'cui_str': 'Plastic repair of tendon'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",64.0,0.0640378,"This computer-assisted planning for acromioplasty during RCR proved no benefits in terms of bone removal, tendon healing, or clinical outcomes.","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lädermann', 'Affiliation': 'Division of Orthopaedics and Trauma Surgery, La Tour Hospital, Avenue J.-D.-Maillard 3, 1217 Meyrin, Switzerland; Faculty of Medicine, University of Geneva, Geneva, Switzerland; Division of Orthopaedics and Trauma Surgery, Department of Surgery, Geneva University Hospitals, Geneva, Switzerland. Electronic address: alexandre.laedermann@gmail.com.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Chagué', 'Affiliation': 'Medical Research Department, Artanim Foundation, Meyrin, Switzerland.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Preissmann', 'Affiliation': 'Center for Psychiatric Neuroscience, Department of Psychiatry, Lausanne University Hospital, CH-1008 Prilly, Switzerland.'}, {'ForeName': 'Franck C', 'Initials': 'FC', 'LastName': 'Kolo', 'Affiliation': 'Rive Droite Radiology Center, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Rime', 'Affiliation': 'Division of Physiotherapy, La Tour Hospital, Meyrin, Switzerland.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Kevelham', 'Affiliation': 'Medical Research Department, Artanim Foundation, Meyrin, Switzerland.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Bothorel', 'Affiliation': 'ReSurg SA, Nyon, Switzerland.'}, {'ForeName': 'Caecilia', 'Initials': 'C', 'LastName': 'Charbonnier', 'Affiliation': 'Faculty of Medicine, University of Geneva, Geneva, Switzerland; Medical Research Department, Artanim Foundation, Meyrin, Switzerland.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.02.010']
3337,32444220,A Phase II Randomized Clinical Trial of the Safety and Efficacy of Intravenous Umbilical Cord Blood Infusion for Treatment of Children with Autism Spectrum Disorder.,"OBJECTIVE


To evaluate whether umbilical cord blood (CB) infusion is safe and associated with improved social and communication abilities in children with autism spectrum disorder (ASD).
STUDY DESIGN


This prospective, randomized, placebo-controlled, double-blind study included 180 children with ASD, aged 2-7 years, who received a single intravenous autologous (n = 56) or allogeneic (n = 63) CB infusion vs placebo (n = 61) and were evaluated at 6 months postinfusion.
RESULTS


CB infusion was safe and well tolerated. Analysis of the entire sample showed no evidence that CB was associated with improvements in the primary outcome, social communication (Vineland Adaptive Behavior Scales-3 [VABS-3] Socialization Domain), or the secondary outcomes, autism symptoms (Pervasive Developmental Disorder Behavior Inventory) and vocabulary (Expressive One-Word Picture Vocabulary Test). There was also no overall evidence of differential effects by type of CB infused. In a subanalysis of children without intellectual disability (ID), allogeneic, but not autologous, CB was associated with improvement in a larger percentage of children on the clinician-rated Clinical Global Impression-Improvement scale, but the OR for improvement was not significant. Children without ID treated with CB showed significant improvements in communication skills (VABS-3 Communication Domain), and exploratory measures including attention to toys and sustained attention (eye-tracking) and increased alpha and beta electroencephalographic power.
CONCLUSIONS


Overall, a single infusion of CB was not associated with improved socialization skills or reduced autism symptoms. More research is warranted to determine whether CB infusion is an effective treatment for some children with ASD.",2020,"Children without ID treated with CB showed significant improvements in communication skills (VABS-3 Communication Domain), and exploratory measures including attention to toys and sustained attention (eye-tracking) and increased alpha and beta electroencephalographic power.
","['Children with Autism Spectrum Disorder', 'children with ASD', 'children with autism spectrum disorder (ASD', '180 children with ASD, aged 2-7\xa0years, who received a single intravenous autologous (n\xa0=\xa056) or allogeneic (n\xa0=\xa063']","['CB', 'CB infusion vs placebo', 'Intravenous Umbilical Cord Blood Infusion', 'CB infusion', 'umbilical cord blood (CB) infusion', 'placebo']","['socialization skills or reduced autism symptoms', 'social communication (Vineland Adaptive Behavior Scales-3 [VABS-3] Socialization Domain), or the secondary outcomes, autism symptoms (Pervasive Developmental Disorder Behavior Inventory) and vocabulary (Expressive One-Word Picture Vocabulary Test', 'communication skills (VABS-3 Communication Domain), and exploratory measures including attention to toys and sustained attention (eye-tracking) and increased alpha and beta electroencephalographic power', 'safe and well tolerated']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}]","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales'}, {'cui': 'C0077962', 'cui_str': 'VAB-III protocol'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0042927', 'cui_str': 'Vocabulary Tests'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040565', 'cui_str': 'Toy'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]",180.0,0.486169,"Children without ID treated with CB showed significant improvements in communication skills (VABS-3 Communication Domain), and exploratory measures including attention to toys and sustained attention (eye-tracking) and increased alpha and beta electroencephalographic power.
","[{'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Dawson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC; Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC. Electronic address: geraldine.dawson@duke.edu.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Sun', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Compton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Deaver', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Franz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Heilbron', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Herold', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Horrigan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Howard', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kosinski', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Major', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Murias', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Vinod K', 'Initials': 'VK', 'LastName': 'Prasad', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Sabatos-DeVito', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Sanfilippo', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Linmarie', 'Initials': 'L', 'LastName': 'Sikich', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Simmons', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Song', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC; Duke Brain Imaging and Analysis Center, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Saritha', 'Initials': 'S', 'LastName': 'Vermeer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Waters-Pick', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Troy', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Kurtzberg', 'Affiliation': 'Marcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.03.011']
3338,32444221,Efficacy of a Primary Care-Based Intervention to Promote Parent-Teen Communication and Well-Being: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate the impact of a primary care-based, parent-directed intervention on changes in parent-teen communication, parental beliefs about adolescents, parent and adolescent well-being, adolescent distress, and adolescent positive affect from baseline to 2-month follow-up.
STUDY DESIGN


In this randomized controlled trial, 120 adolescents (13-15 years of age) scheduled for well visits and their parents were randomized to the strength intervention or control group. The intervention included a booklet highlighting 3 key messages about adolescence, instructions to have a discussion with their teen about each other's strengths, and clinician endorsement. Outcomes were assessed before the well visit and 2 months later.
RESULTS


Adolescents were 61% female and 65% black. Parents were primarily female (97%); 72% had a 4-year degree or higher. The intervention had a positive impact on adolescent-reported open communication among adolescents with baseline low open communication scores (B = 3.55; P = .005; 95% CI, 1.07-6.03). Adolescents in the intervention group reported a decrease in distress (-1.54 vs 3.78; P = .05; partial eta squared [η 2 ] = 0.038) and increase in positive affect (1.30 vs -3.64; P = .05; η 2  = 0.04) compared with control group adolescents. The intervention did not affect parent-reported communication, parental beliefs, or adolescent well-being. Control parents demonstrated a marginal increase in well-being, whereas intervention parents did not (0.82 vs -0.18; P = .07; η 2  = 0.029).
CONCLUSIONS


This study highlights the potential impact of primary care-based, universal, low-intensity interventions targeting parents of adolescents on parent-teen communication and important adolescent health outcomes.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT03496155.",2020,Adolescents in the intervention group reported a decrease in distress (-1.54 vs 3.78; P = .05; partial eta squared [η 2 ] = 0.038) and increase in positive affect (1.30 vs -3.64; P = .05; η 2  = 0.04) compared with control group adolescents.,"['120 adolescents (13-15\xa0years of age) scheduled for well visits and their parents', 'Parents were primarily female (97%); 72% had a 4-year degree or higher', 'Adolescents were 61% female and 65% black']","[""booklet highlighting 3 key messages about adolescence, instructions to have a discussion with their teen about each other's strengths, and clinician endorsement"", 'primary care-based, parent-directed intervention', 'Primary Care-Based Intervention to Promote Parent-Teen Communication and Well-Being', 'strength intervention or control group']","['distress', 'communication, parental beliefs, or adolescent well-being']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C4042782', 'cui_str': 'Adolescent Well Being'}]",120.0,0.116073,Adolescents in the intervention group reported a decrease in distress (-1.54 vs 3.78; P = .05; partial eta squared [η 2 ] = 0.038) and increase in positive affect (1.30 vs -3.64; P = .05; η 2  = 0.04) compared with control group adolescents.,"[{'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Miller', 'Affiliation': ""Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, PA; Division of Adolescent Medicine, Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Center for Parent and Teen Communication, Children's Hospital of Philadelphia, Philadelphia, PA. Electronic address: millerv@email.chop.edu.""}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Silva', 'Affiliation': ""Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Friedrich', 'Affiliation': ""Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, PA; Center for Parent and Teen Communication, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Reyneris', 'Initials': 'R', 'LastName': 'Robles', 'Affiliation': ""Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, PA; Center for Parent and Teen Communication, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Ford', 'Affiliation': ""Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, PA; Division of Adolescent Medicine, Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Center for Parent and Teen Communication, Children's Hospital of Philadelphia, Philadelphia, PA.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.03.050']
3339,32444230,"The Impact of Epinephrine in the Periarticular Injection Cocktail using Ropivacaine for Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind Comparison Study.","BACKGROUND


Epinephrine is used in periarticular injection using ropivacaine to produce a synergistic effect when used with local anesthetic agents but the effect has not been proven yet. The purpose of this study is to evaluate how effective epinephrine is on postoperative clinical outcomes in primary total knee arthroplasty (TKA).
METHODS


One hundred sixteen cases (89 patients) who underwent primary TKA were randomized into 2 groups depending on whether epinephrine was mixed. Immediately after the operation, patient-controlled analgesia using fentanyl was initiated. The Numerical Rating Scale, the cumulative dose of fentanyl, active range of motion of the knee joint, and wound complications were evaluated postoperatively.
RESULTS


There were no significant differences in mean postoperative Numerical Rating Scale, cumulative dose of fentanyl, and active range of motion between the 2 groups. Neither skin necrosis nor wound dehiscence requiring operative management for skin care was required in either group.
CONCLUSION


The use of epinephrine in periarticular injection using ropivacaine after TKA did not have any effect on postoperative acute pain control and opioid usage.
THE LEVEL OF EVIDENCE


Therapeutic level I.",2020,"There were no significant differences in mean postoperative Numerical Rating Scale, cumulative dose of fentanyl, and active range of motion between the 2 groups.","['One hundred sixteen cases (89 patients) who underwent primary TKA', 'Total Knee Arthroplasty', 'primary total knee arthroplasty (TKA']","['ropivacaine', 'Epinephrine', 'Ropivacaine', 'epinephrine']","['postoperative acute pain control and opioid usage', 'Numerical Rating Scale, the cumulative dose of fentanyl, active range of motion of the knee joint, and wound complications', 'mean postoperative Numerical Rating Scale, cumulative dose of fentanyl, and active range of motion']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1171175', 'cui_str': 'Acute pain control'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",116.0,0.16959,"There were no significant differences in mean postoperative Numerical Rating Scale, cumulative dose of fentanyl, and active range of motion between the 2 groups.","[{'ForeName': 'Dong Yi', 'Initials': 'DY', 'LastName': 'Kong', 'Affiliation': 'Department of Orthopaedic Surgery, Juan Nanoori Hospital, Incheon, South Korea.'}, {'ForeName': 'Jeong Han', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Orthopaedic Surgery, HeeMyoung General Hospital, Seoul, South Korea.'}, {'ForeName': 'Won Rak', 'Initials': 'WR', 'LastName': 'Choi', 'Affiliation': 'Department of Orthopaedic Surgery, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young-Il', 'Initials': 'YI', 'LastName': 'Ko', 'Affiliation': 'Department of Orthopaedic Surgery, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Choong H', 'Initials': 'CH', 'LastName': 'Choi', 'Affiliation': 'Department of Orthopaedic Surgery, Hanyang University College of Medicine, Seoul, South Korea.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.04.042']
3340,32445004,Effect of Information-Motivation-Behavioral Model Based on Protection Motivation Theory on the Psychological Resilience and Quality of Life of Patients with Type 2 DM.,"Diabetes mellitus (DM) is one of the remarkable disease challenges in the twenty-first century and poses threat to patients' physical health. Given the difficulty of treatment and the high possibility of relapse, patients often have mental illness. A total of 117 patients with type 2 DM were randomly divided into two groups for a 2-month intervention. The intervention group underwent an Information-Motivation-Behavioral skills (IMB) intervention program based on protection motivation theory, and traditional intervention was applied to the control group. No significant difference is found between the intervention and control groups before the intervention (P > 0.05). However, after the intervention, the blood glucose level and depression score of the intervention group are lower than those of the control group (P < 0.05), and the psychological resilience and quality of life are significantly higher than those of the control group (P < 0.05). The blood glucose level and depression score of the intervention group decrease after the intervention (P < 0.05), and the psychological resilience and quality of life are significantly increase (P < 0.05). No significant difference is found in the blood glucose level, depression, psychological resilience, and quality of life of the control group before and after the intervention (P > 0.05). The combination of IMB intervention and protection motivation theory is important to improving the psychological resilience of patients with type 2 DM, raising their quality of life and reducing their blood glucose level.",2020,"No significant difference is found in the blood glucose level, depression, psychological resilience, and quality of life of the control group before and after the intervention (P > 0.05).","['117 patients with type 2 DM', 'Patients with Type 2 DM', 'Diabetes mellitus (DM']","['IMB intervention and protection motivation theory', 'Information-Motivation-Behavioral skills (IMB) intervention program based on protection motivation theory, and traditional intervention', 'Information-Motivation-Behavioral Model']","['psychological resilience and quality of life', 'Psychological Resilience and Quality of Life', 'blood glucose level and depression score', 'blood glucose level, depression, psychological resilience, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",117.0,0.0135115,"No significant difference is found in the blood glucose level, depression, psychological resilience, and quality of life of the control group before and after the intervention (P > 0.05).","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': ""Endoscopy Center, The Xiang'an Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, 361101, Fujian, China.""}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics, The Xiang'an Hospital of Xiamen University, School of Medicine, Xiamen University, No. 2000, Xiang'an East Road, Xiang'an District, Xiamen, 361101, China. zhangll0592@163.com.""}, {'ForeName': 'Jiwei', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': ""Nursing Department, The Xiang'an Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, 361101, Fujian, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopaedics, The 1st Affiliated Hospital of Harbin Medical University, Harbin, 150001, China.'}]",The Psychiatric quarterly,['10.1007/s11126-020-09783-w']
3341,32445052,"PPARγ activation by pioglitazone does not suppress cravings for alcohol, and is associated with a risk of myopathy in treatment seeking alcohol dependent patients: a randomized controlled proof of principle study.","RATIONALE


Proinflammatory processes have been implicated in alcohol addiction, craving, and relapse, while studies in experimental animals have suggested that activation of peroxisome proliferator-activated receptor gamma (PPARγ) inhibits proinflammatory signaling. Accordingly, it is hypothesized that medications with PPARγ activity may have therapeutic potential in alcohol dependence.
OBJECTIVES


We conducted a double-blind, placebo-controlled mechanistic proof of principle study in alcohol-dependent inpatients to investigate the effect of pioglitazone on alcohol craving.
METHODS


Participants were treated for withdrawal, if needed, and then randomized to pioglitazone (target dose 45 mg/day) or placebo. Once at target dose, they completed two experimental manipulations: guided imagery, which used personalized auditory scripts to induce alcohol cravings, and a low-dose challenge with i.v. lipopolysaccharide (LPS; 0.8 ng/kg) or placebo, on two separate sessions, in counterbalanced order. Behavioral and endocrine responses as well as CSF levels of proinflammatory cytokines were evaluated.
RESULTS


The study was prematurely terminated after randomization of 16 subjects, following an independent review that established a high risk of myopathy in the active treatment group. Analysis of those who completed the study indicated that pioglitazone was associated with elevated, rather than suppressed alcohol cravings in response to alcohol-associated stimuli. LPS did not induce cravings for alcohol and thus did not lend itself to evaluating pioglitazone effects; however, pioglitazone increased the neuroendocrine stress response to LPS. CSF levels of IL-6, TNF-α, or MCP-1 were unaffected by pioglitazone treatment.
CONCLUSIONS


Both safety and efficacy biomarker data suggest that pioglitazone lacks potential as a medication for the treatment of alcohol dependence.
CLINICAL TRIAL REGISTRATION


NCT01631630.",2020,"CSF levels of IL-6, TNF-α, or MCP-1 were unaffected by pioglitazone treatment.
",['Participants'],"['pioglitazone', 'LPS', 'lipopolysaccharide', 'placebo']","['alcohol cravings', 'CSF levels of proinflammatory cytokines', 'Behavioral and endocrine responses', 'CSF levels of IL-6, TNF-α, or MCP-1']",[],"[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}]",,0.162741,"CSF levels of IL-6, TNF-α, or MCP-1 were unaffected by pioglitazone treatment.
","[{'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, 10 Center Drive, CRC 1-5330, Bethesda, MD, 20892, USA. melanies@mail.nih.gov.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Diazgranados', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, 10 Center Drive, CRC 1-5330, Bethesda, MD, 20892, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Umhau', 'Affiliation': 'Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration, Washington, DC, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Kwako', 'Affiliation': 'Division of Treatment and Recovery Research, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'George', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, 10 Center Drive, CRC 1-5330, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Center for Social and Affective Neuroscience, Linköping University, Linköping, Sweden.'}]",Psychopharmacology,['10.1007/s00213-020-05540-w']
3342,32445077,Outcomes of ketorolac versus depomedrol infiltrations for subacromial impingement syndrome: a randomized controlled trial.,"PURPOSE


Local subacromial infiltration with steroids is a common method of treatment of subacromial impingement syndrome. However, the use of steroids has concerns like tendon rupture, articular cartilage changes and infections. Local NSAIDs infiltration has recently been tried in literature. This study compares the effect of subacromial injections of ketorolac with steroids.
METHODS


A randomized controlled study was planned with 35 patients in each group. Patients in group-1 were infiltrated with subacromial ketorolac (60 mg with 2% lignocaine) and in group-2 with a steroid (methylprednisolone-40 mg with 2% lignocaine). A similar rehabilitation protocol was followed, and clinical outcomes were analyzed using visual analog scale (VAS) for pain and shoulder pain and disability score (SPADI) and range of motion at one-month and three-months follow-up.
RESULTS


Total data of 67 patients were analyzed, as three patients were lost to follow-up. In group 1, mean VAS improved from 7.9 [Formula: see text] 0.95 to 3.19 [Formula: see text] 0.81 (p < 0.001) and SPADI improved from 61.41 [Formula: see text] 11.86 to 28.91 [Formula: see text] 9.06 (p < 0.001) at three months, respectively. In group 2, mean VAS improved from 8.05 [Formula: see text] 0.94 to 2.9 [Formula: see text] 0.64 (p < 0.001) and SPADI improved from 63.45 [Formula: see text] 9.64 to 25.32 [Formula: see text] 6.87 (p < 0.001) at three months, respectively. However, there were no differences in functional outcomes between the groups (p = 0.21 for VAS, p = 0.16 for SPADI).
CONCLUSION


Subacromial ketorolac infiltration has an equivalent outcome as that of steroid infiltration. Ketorolac could be considered as a reasonable alternative to steroids in cases where it is contraindicated.",2020,"However, there were no differences in functional outcomes between the groups (p = 0.21 for VAS, p = 0.16 for SPADI).
","['subacromial impingement syndrome', '35 patients in each group']","['Ketorolac', 'steroid (methylprednisolone-40\xa0mg with 2% lignocaine', 'steroids', 'ketorolac', 'lignocaine', 'subacromial ketorolac', 'ketorolac with steroids']","['functional outcomes', 'SPADI', 'mean VAS', 'visual analog scale (VAS) for pain and shoulder pain and disability score (SPADI) and range of motion']","[{'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C1125541', 'cui_str': 'Methylprednisolone 40 MG'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",67.0,0.0689275,"However, there were no differences in functional outcomes between the groups (p = 0.21 for VAS, p = 0.16 for SPADI).
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Goyal', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, AIIMS, Virbhadra Marg, Rishikesh, Uttarakhand, 249201, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, AIIMS, Virbhadra Marg, Rishikesh, Uttarakhand, 249201, India.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Sethy', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, AIIMS, Virbhadra Marg, Rishikesh, Uttarakhand, 249201, India. sekhar.ciddharth@gmail.com.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Choudhury', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, AIIMS, Virbhadra Marg, Rishikesh, Uttarakhand, 249201, India.'}]",Musculoskeletal surgery,['10.1007/s12306-020-00667-7']
3343,32445184,Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program.,"INTRODUCTION


Etrolizumab is a next-generation anti-integrin with dual action that targets two pathways of inflammation in the gut. A robust phase 3 clinical program in ulcerative colitis (UC) and Crohn's disease is ongoing and will evaluate the efficacy and safety of etrolizumab in well-defined patient populations in rigorous trials that include direct head-to-head comparisons against approved anti-tumor necrosis factor alpha agents (anti-TNF). The etrolizumab phase 3 clinical program consists of six randomized controlled trials (RCTs; UC: HIBISCUS I and II, GARDENIA, LAUREL, HICKORY; Crohn's disease: BERGAMOT) and two open-label extension trials (OLEs; UC: COTTONWOOD; Crohn's disease: JUNIPER) evaluating patients with moderately to severely active UC or Crohn's disease.
METHODS


In the UC RCTs, patients are randomly assigned according to each protocol to receive etrolizumab, adalimumab, infliximab, or placebo. In BERGAMOT, patients are randomly assigned to receive etrolizumab 105 mg, etrolizumab 210 mg, or placebo. The primary outcomes for the UC RCTs are Mayo Clinic score-based clinical response, remission, and clinical remission; for BERGAMOT, the co-primary outcomes are clinical remission (based on abdominal pain and stool frequency) and endoscopic improvement (based on the Simple Endoscopic Score for Crohn's disease). The OLEs will primarily assess long-term efficacy and safety. Secondary and exploratory endpoints include endoscopy, histology, quality of life, and biomarkers at various timepoints.
DISCUSSION


The etrolizumab phase 3 clinical program is the largest and most comprehensive in inflammatory bowel disease, enrolling more than 3000 patients. The program explores both induction and maintenance regimens. HIBISCUS I and II and GARDENIA are among the first head-to-head trials in UC against an anti-TNF and are the first registrational trials making that comparison. This program will also help address unanswered clinical questions on evaluation of treatment effects and treatment selection across a range of patients with varying treatment histories using an extensive repository of patient samples and data.
TRIAL REGISTRATION


ClinicalTrials.gov: HIBISCUS I (NCT02163759), HIBISCUS II (NCT02171429), GARDENIA (NCT02136069), LAUREL (NCT02165215), HICKORY (NCT02100696), COTTONWOOD (NCT02118584), BERGAMOT (NCT02394028), JUNIPER (NCT02403323).",2020,HIBISCUS ,"['3000 patients', ""Ulcerative Colitis and Crohn's Disease"", ""patients with moderately to severely active UC or Crohn's disease""]","['Etrolizumab', 'etrolizumab, adalimumab, infliximab, or placebo', 'etrolizumab 105\xa0mg, etrolizumab 210\xa0mg, or placebo', 'etrolizumab']","[""UC RCTs are Mayo Clinic score-based clinical response, remission, and clinical remission; for BERGAMOT, the co-primary outcomes are clinical remission (based on abdominal pain and stool frequency) and endoscopic improvement (based on the Simple Endoscopic Score for Crohn's disease"", 'endoscopy, histology, quality of life, and biomarkers at various timepoints']","[{'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3177463', 'cui_str': 'rhuMAb Beta7'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.181287,HIBISCUS ,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Vermeire', 'Affiliation': 'University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tyrrell', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Azra', 'Initials': 'A', 'LastName': 'Hassanali', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lacey', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Tole', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Tatro', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland. amanda.tatro@roche.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-020-01366-2']
3344,31626688,"Erratum to: Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial.",,2020,,['Community-acquired Bacterial Pneumonia'],"['Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic']",[],"[{'cui': 'C0456394', 'cui_str': 'Community acquired'}, {'cui': 'C0004626', 'cui_str': 'Bacterial pneumonia'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0071283', 'cui_str': 'Pleuromutilin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",[],,0.017979,,"[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'File', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Goldberg', 'Affiliation': ''}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': ''}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Sweeney', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Saviski', 'Affiliation': ''}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Gelone', 'Affiliation': ''}, {'ForeName': 'Elyse', 'Initials': 'E', 'LastName': 'Seltzer', 'Affiliation': ''}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Paukner', 'Affiliation': ''}, {'ForeName': 'Wolfgang W', 'Initials': 'WW', 'LastName': 'Wicha', 'Affiliation': ''}, {'ForeName': 'George H', 'Initials': 'GH', 'LastName': 'Talbot', 'Affiliation': ''}, {'ForeName': 'Leanne B', 'Initials': 'LB', 'LastName': 'Gasink', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz710']
3345,30123942,Population Pharmacokinetics of the Interleukin-23 Inhibitor Risankizumab in Subjects with Psoriasis and Crohn's Disease: Analyses of Phase I and II Trials.,"BACKGROUND AND OBJECTIVES


Risankizumab is a humanized anti-interleukin-23 monoclonal antibody in development for the treatment of several inflammatory diseases. This work characterized the pharmacokinetics of risankizumab and evaluated covariates that may affect its exposures using phase I and II trial data in subjects with psoriasis and Crohn's disease.
METHODS


Plasma concentration measurements from a phase I study and a phase II study in subjects with psoriasis (n = 157; single doses of 0.01-5 mg/kg intravenously, 0.25-1 mg/kg subcutaneously, and 18 mg subcutaneously, and multiple doses of 90 and 180 mg subcutaneously), and a phase II study in subjects with Crohn's disease (n = 115; doses of 200 or 600 mg intravenously every 4 weeks followed by 180 mg subcutaneously every 8 weeks) were analyzed using non-linear mixed-effects modeling. The model was qualified using bootstrap and simulation-based diagnostics.
RESULTS


A two-compartment model with first-order absorption and elimination described the pharmacokinetics of risankizumab. Considering the body weight and baseline albumin central tendency differences between disease populations, risankizumab clearance, steady-state volume of distribution, and terminal-phase elimination half-life were estimated to be approximately 0.35 L/day, 11.7 L, and 27 days, respectively, for a typical 90-kg subject with psoriasis with an albumin level of 42 g/L, and 0.31 L/day, 8.45 L, and 22 days, respectively, for a typical 65-kg subject with Crohn's disease with an albumin level of 37 g/L. Risankizumab absolute subcutaneous bioavailability and absorption rate constant were 72% and 0.18 day -1 , respectively. Inter-individual variability for clearance was 37%.
CONCLUSIONS


Risankizumab displayed pharmacokinetic characteristics typical for an IgG1 monoclonal antibody with no apparent target-mediated disposition. Accounting for the effects of body weight and baseline albumin explained the small differences in the pharmacokinetics of risankizumab between psoriasis and Crohn's disease, with no further differences between the patient populations.",2019,"Inter-individual variability for clearance was 37%.
","[""subjects with psoriasis and Crohn's disease"", ""Subjects with Psoriasis and Crohn's Disease"", 'subjects with psoriasis (n\u2009=\u2009157']","['single doses of 0.01-5\xa0mg/kg intravenously, 0.25-1\xa0mg/kg subcutaneously, and 18\xa0mg subcutaneously, and multiple doses of 90 and 180\xa0mg subcutaneously', 'Interleukin-23 Inhibitor Risankizumab']","['risankizumab clearance, steady-state volume of distribution, and terminal-phase elimination half-life', 'Risankizumab absolute subcutaneous bioavailability and absorption rate constant']","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4505511', 'cui_str': 'risankizumab'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]",,0.0558151,"Inter-individual variability for clearance was 37%.
","[{'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Suleiman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Khatri', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Minocha', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA. ahmed.othman@abbvie.com.'}]",Clinical pharmacokinetics,['10.1007/s40262-018-0704-z']
3346,32445228,T-Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial.,"In the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) clinical trial (NCT01631214), 1 year of romosozumab followed by alendronate reduced the risk of vertebral and nonvertebral fractures compared to alendronate alone in women with prevalent fracture. We performed post hoc analyses of data from patients in ARCH (romosozumab, n = 1739; alendronate, n = 1726) who had a baseline BMD measurement and received at least one open-label alendronate dose. We evaluated 1-year mean BMD and corresponding T-score changes; proportions of patients achieving T-scores > -2.5 at the total hip (TH), femoral neck (FN), and lumbar spine (LS); and group differences in fracture rates after 12 months, while all participants were on alendronate. Subsequently, we investigated the relationship between T-scores achieved at the TH, FN, and LS at 12 months and subsequent fracture incidence. At 1 year, mean change from baseline in TH BMD was 6.3% (T-score change 0.31) with romosozumab versus 2.9% (T-score change 0.15) with alendronate (p < .001). The proportion of patients with TH T-score > -2.5 increased from 34% at baseline to 55% after 1 year of romosozumab and from 32% at baseline to 44% after 1 year of alendronate. Compared with patients receiving alendronate in year 1, those receiving romosozumab had a 75% reduction in new or worsening vertebral fracture (p < .001) in year 2, and a 19% reduction in nonvertebral fracture (p = .120) and 40% reduction in hip fracture (p = .041) during the open-label period. TH and FN T-scores achieved at month 12 were associated with subsequent nonvertebral and vertebral fracture rates and the relationships were independent of treatment received. LS T-score at 12 months was associated with vertebral but not nonvertebral fracture risk. We conclude that 1 year of romosozumab leads to larger BMD gains versus alendronate, and that the T-score achieved with either therapy is related to subsequent fracture risk. These data support the use of T-score as a therapeutic target for patients with osteoporosis. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.",2020,TH and FN T-scores achieved at month 12 were associated with subsequent nonvertebral and vertebral fracture rates and the relationships were independent of treatment received.,"['patients in ARCH (romosozumab, n =\u20091739; alendronate, n =\u20091726) who had a baseline BMD measurement and received at least one open-label alendronate dose', '2020', 'women with prevalent fracture', 'Postmenopausal Women With Osteoporosis at High Risk (ARCH', 'patients with osteoporosis']","['alendronate alone', 'Romosozumab or Alendronate', 'alendronate']","['LS T-score', 'fracture rates', 'new or worsening vertebral fracture', 'TH and FN T-scores', 'BMD gains', 'TH BMD', 'nonvertebral and vertebral fracture rates', 'proportion of patients with TH T-score', 'total hip (TH), femoral neck (FN), and lumbar spine (LS', 'hip fracture', 'nonvertebral fracture', 'Fracture Risk', '1-year mean BMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C3661283', 'cui_str': 'romosozumab'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C3661283', 'cui_str': 'romosozumab'}]","[{'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0761765,TH and FN T-scores achieved at month 12 were associated with subsequent nonvertebral and vertebral fracture rates and the relationships were independent of treatment received.,"[{'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'E Michael', 'Initials': 'EM', 'LastName': 'Lewiecki', 'Affiliation': 'New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, USA.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ebeling', 'Affiliation': 'Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hesse', 'Affiliation': 'Institute of Molecular Musculoskeletal Research, Faculty of Medicine, Ludwig-Maximilians-University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Napoli', 'Affiliation': 'Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Fujii Memorial Institute of Medical Sciences, University of Tokushima, Tokushima, Japan.'}, {'ForeName': 'Daria B', 'Initials': 'DB', 'LastName': 'Crittenden', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rojeski', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Libanati', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Ferrari', 'Affiliation': 'Service and Laboratory of Bone Diseases, Geneva University Hospital, Geneva, Switzerland.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3996']
3347,32445247,Benefits of extracorporeal shock waves for keloid treatment: A pilot study.,"Keloids are fibroproliferative skin disorders characterized by the progressive deposition of collagen. Recently, extracorporeal shock wave therapy (ESWT) has been used to treat pathologic scars. Herein, we conducted a study to compare the efficacy of intralesional injections (ILIs) of triamcinolone acetonide (TA) used alone, or in combination with ESWT for keloids. Forty patients were randomized equally into two groups in this 12-week comparative clinical trial. Group A was treated with TA ILIs and ESWT, and group B was treated with TA ILIs alone. At week 12, both groups showed acceptable improvements in nearly all dimensions evaluated, and these improvements were statistically more significant in group A. Group A showed a higher mean percentage reduction in lesion length, width, and height and in the VSS score than group B (all p < 0.05). More patients in group A than in group B had scores of ≥4, which indicated improvements that were good or excellent, on the PGA and IGA. No serious adverse events occurred. This study suggests that ESWT could be a new, effective and acceptable adjuvant treatment option for keloids. This article is protected by copyright. All rights reserved.",2020,"More patients in group A than in group B had scores of ≥4, which indicated improvements that were good or excellent, on the PGA and IGA.",['Forty patients'],"['TA ILIs and ESWT', 'extracorporeal shock wave therapy (ESWT', 'intralesional injections (ILIs) of triamcinolone acetonide (TA', 'ESWT', 'TA ILIs alone', 'extracorporeal shock waves for keloid treatment']","['lesion length, width, and height and in the VSS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0021490', 'cui_str': 'Intralesional injection'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0022548', 'cui_str': 'Keloid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0138915,"More patients in group A than in group B had scores of ≥4, which indicated improvements that were good or excellent, on the PGA and IGA.","[{'ForeName': 'Dong Hee', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.'}, {'ForeName': 'Seok Hyun', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Dermatology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.'}, {'ForeName': 'Ho Seok', 'Initials': 'HS', 'LastName': 'Suh', 'Affiliation': 'Department of Dermatology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.'}, {'ForeName': 'Yu Sung', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.'}]",Dermatologic therapy,['10.1111/dth.13653']
3348,30852244,Effects of a behavioural weight loss intervention in people with serious mental illness: Subgroup analyses from the ACHIEVE trial.,"BACKGROUND


Persons with serious mental illnesses (SMI) such as schizophrenia and bipolar disorder have an increased risk of obesity and related chronic diseases and die 10-20years earlier than the overall population, primarily due to cardiovascular disease. In the ACHIEVE trial, a behavioural weight loss intervention led to clinically significant weight loss in persons with SMI. As the field turns its attention to intervention scale-up, it is important to understand whether the effectiveness of behavioural weight loss interventions for people with SMI, like ACHIEVE, differ for specific subgroups.
METHODS


This study examined whether the effectiveness of the ACHIEVE intervention differed by participant characteristics (e.g. age, sex, race, psychiatric diagnosis, body mass index) and/or their weight-related attitudes and behaviours (e.g. eating, food preparation, and shopping habits). We used likelihood-based mixed effects models to examine whether the baseline to 18 month effects of the ACHIEVE intervention differed across subgroups.
RESULTS


No statistically significant differences were found in the effectiveness of the ACHIEVE intervention across any of the subgroups examined.
CONCLUSIONS


These findings suggest that the ACHIEVE behavioural weight loss intervention is broadly applicable to the diverse population of individuals with SMI.",2019,"No statistically significant differences were found in the effectiveness of the ACHIEVE intervention across any of the subgroups examined.
","['Persons with serious mental illnesses (SMI', 'persons with SMI', 'people with serious mental illness', 'people with SMI']",['behavioural weight loss intervention'],['weight loss'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0385761,"No statistically significant differences were found in the effectiveness of the ACHIEVE intervention across any of the subgroups examined.
","[{'ForeName': 'Eleanore', 'Initials': 'E', 'LastName': 'Alexander', 'Affiliation': 'Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, United States. Electronic address: ealexa12@jhmi.edu.'}, {'ForeName': 'Emma E', 'Initials': 'EE', 'LastName': 'McGinty', 'Affiliation': 'Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, United States.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States; Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, United States; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, United States; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medicine, Baltimore, MD, 21205, United States.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Dalcin', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medicine, Baltimore, MD, 21205, United States.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Jerome', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States; Department of Kinesiology, Towson University, Baltimore, MD, 21252, United States.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medicine, Baltimore, MD, 21205, United States.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Dickerson', 'Affiliation': 'Stanley Research Program, Sheppard Pratt Health System, Baltimore, MD 21204, United States.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Charleston', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medicine, Baltimore, MD, 21205, United States.'}, {'ForeName': 'Deborah R', 'Initials': 'DR', 'LastName': 'Young', 'Affiliation': 'Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, CA, 91024, United States.'}, {'ForeName': 'Joseph V', 'Initials': 'JV', 'LastName': 'Gennusa', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Goldsholl', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medicine, Baltimore, MD, 21205, United States.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medicine, Baltimore, MD, 21205, United States.'}, {'ForeName': 'Gail L', 'Initials': 'GL', 'LastName': 'Daumit', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medicine, Baltimore, MD, 21205, United States.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2019.02.002']
3349,30885718,Serum adiponectin is associated with body composition and cognitive and psychological status in older adults living in long-term nursing homes.,"Frailty is a geriatric syndrome characterized by decreasing functional reserves and increasing vulnerability to falls, injuries and declining health, leading to dependence upon caregivers. Frailty is associated not only with physical decline, but also with cognitive and psychological impairments in aging people. Higher serum adiponectin concentration has been linked to better performance on frailty measures but also to worse cognitive status. Nonetheless, several studies have proposed adiponectin as a frailty biomarker. To further delineate the relationship between adiponectin serum levels and frailty-related parameters, we studied a population of 112 long-term nursing home residents (aged 84.9 ± 6.7) and analyzed their serum adiponectin levels in conjunction with frailty-related parameters including body composition, physical fitness, cognitive function, psychological parameters and quality of life. Frailty was assessed following the Fried Frailty Criteria, the Clinical Frailty Scale and the Tilburg Frailty Indicator. In women, higher serum adiponectin levels were associated with lower body weight, body mass index, body fat mass, fat mass/height 2 , lean mass, lean mass/height 2  and smaller waist circumference and hip circumference (p < 0.05). In men, the association was positive (p < 0.05) between serum adiponectin and percentage of fat mass and negative between serum adiponectin and percentage of lean mass. Interestingly, in men, better cognitive function was inversely related to adiponectin (p < 0.05) while decreased anxiety was linked to a higher concentration of adiponectin in women (p < 0.05). According to the Tilburg Frailty Indicator, frail men had lower levels of adiponectin than those who were not frail (p < 0.05). Variables that predicted adiponectin concentration in multiple regression models were different for women and men. In women, lean mass and anxiety were independent negative predictors of blood adiponectin (β = -0.363, p = 0.002; β = -0.204, p = 0.067, respectively). In men, the Montreal Cognitive Assessment (MOCA) test was the only parameter to remain significant in the regression model (β = -439, p = 0.015). The results of our study show that adiponectin is linked to body composition, cognitive function and anxiety in long-term nursing home residents with differential relationships by sex. Further studies should be conducted to determine whether adiponectin is a valid and reliable frailty biomarker.",2019,"Interestingly, in men, better cognitive function was inversely related to adiponectin (p < 0.05) while decreased anxiety was linked to a higher concentration of adiponectin in women (p < 0.05).","['population of 112 long-term nursing home residents (aged 84.9\u202f±\u202f6.7', 'older adults living in long-term nursing homes']",['adiponectin'],"['concentration of adiponectin', 'blood adiponectin', 'anxiety', 'body composition, physical fitness, cognitive function, psychological parameters and quality of life', 'serum adiponectin levels', 'cognitive function', 'levels of adiponectin', 'Montreal Cognitive Assessment (MOCA) test', 'body composition, cognitive function and anxiety', 'serum adiponectin and percentage of fat mass and negative between serum adiponectin and percentage of lean mass']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",112.0,0.014857,"Interestingly, in men, better cognitive function was inversely related to adiponectin (p < 0.05) while decreased anxiety was linked to a higher concentration of adiponectin in women (p < 0.05).","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sanz', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), P.O. Box 699, 48080 Bilbao, Bizkaia, Spain; BioCruces Health Research Institute, Plaza de Cruces, 48903 Barakaldo, Bizkaia, Spain. Electronic address: mariabegona.sanz@ehu.eus.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Arrieta', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), P.O. Box 699, 48080 Bilbao, Bizkaia, Spain. Electronic address: haritz.arrieta@ehu.eus.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hervás', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), P.O. Box 699, 48080 Bilbao, Bizkaia, Spain. Electronic address: gotzone.hervas@ehu.eus.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rezola-Pardo', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), P.O. Box 699, 48080 Bilbao, Bizkaia, Spain. Electronic address: chloe.rezola@ehu.eus.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ruiz-Litago', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), P.O. Box 699, 48080 Bilbao, Bizkaia, Spain. Electronic address: fatima.ruiz@ehu.eus.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Iturburu', 'Affiliation': 'Matia Instituto, Camino de los Pinos 35, E-20018, Donostia-San Sebastian, Gipuzkoa, Spain. Electronic address: miren.iturburu@matiafundazioa.eus.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Gil', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), P.O. Box 699, 48080 Bilbao, Bizkaia, Spain. Electronic address: Susana.gil@ehu.eus.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rodríguez-Larrad', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), P.O. Box 699, 48080 Bilbao, Bizkaia, Spain. Electronic address: ana.rodriguez@ehu.eus.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Irazusta', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), P.O. Box 699, 48080 Bilbao, Bizkaia, Spain. Electronic address: jon.irazusta@ehu.eus.'}]",Experimental gerontology,['10.1016/j.exger.2019.03.005']
3350,31219175,Adult Day Service Use Decreases Likelihood of a Missed Physician's Appointment Among Dementia Caregivers.,"BACKGROUND/OBJECTIVE


Adult day services (ADSs) that provide community-based supervised support for persons with dementia (PWD) may also function as a respite for familial caregivers to attend to self-care needs. Guided by a revised version of the Andersen Healthcare Utilization Model, the objective of this study was to identify the association between use of ADSs and a missed physician's appointment among family caregivers for community-dwelling familial PWD. A secondary objective was to identify other predisposing, enabling, and need factors associated with a missed physician's appointment.
DESIGN


Secondary analysis of baseline, cross-sectional data from two randomized controlled trials (Advancing Caregiver Training, n = 272; and Care of Persons With Dementia in Their Environments, n = 237).
SETTING


Community.
PARTICIPANTS


Community-dwelling caregivers for PWD (n = 509).
MEASUREMENTS


Missed physician's appointment was measured using the caregivers' self-report of one or more missed physician's appointments (yes/no) in the past 6 months. ADS use was measured using the caregivers' self-report of ADS use (yes/no).
RESULTS


Over a third of the caregivers utilized ADSs for their PWD. Caregivers who utilized ADSs for their familial PWD were 49% less likely (95% confidence interval = 0.32-0.81) to miss a physician's appointment in the past 6 months. More black compared to white caregivers missed appointments regardless of ADS use. Caregivers with increased chronic health conditions were more likely to miss a physician's appointment compared to those with fewer conditions.
CONCLUSION


ADSs' provision of respite enables caregivers the time to address self-care needs by decreasing the likelihood that caregivers miss a physician's appointment. Findings suggest that ADSs may promote positive health behaviors for caregivers and should be expanded as part of comprehensive dementia care for families. Factors associated with missed physician appointments need further examination and intervention to support black caregivers.",2019,Caregivers who utilized ADSs for their familial PWD were 49% less likely (95% confidence interval = 0.32-0.81) to miss a physician's appointment in the past 6 months.,"['Dementia Caregivers', 'persons with dementia (PWD', 'Community', 'Community-dwelling caregivers for PWD (n = 509', 'Persons With Dementia in Their Environments, n = 237', 'family caregivers for community-dwelling familial PWD']",[],"['chronic health conditions', 'positive health behaviors']","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",509.0,0.0348899,Caregivers who utilized ADSs for their familial PWD were 49% less likely (95% confidence interval = 0.32-0.81) to miss a physician's appointment in the past 6 months.,"[{'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Parker', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Gaugler', 'Affiliation': 'Long-Term Care and Aging, School of Public Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Quincy', 'Initials': 'Q', 'LastName': 'Samus', 'Affiliation': 'Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'College of Nursing and Health Professions, Drexel University, Philadelphia, Pennsylvania.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15995']
3351,31225906,Preoperative PET/CT does not accurately detect extrauterine disease in patients with newly diagnosed high-risk endometrial cancer: A prospective study.,"BACKGROUND


The identification of extrauterine disease is critical to the management of patients with high-risk endometrial cancer. The purpose of the current study was to determine the accuracy of preoperative positron emission tomography (PET)/computed tomography (CT) in the detection of extrauterine disease.
METHODS


Women with high-risk endometrial cancer were enrolled prospectively and underwent preoperative PET/CT followed by surgery, including sentinel lymph node biopsy and lymphadenectomy. Primary tumor factors on PET/CT were correlated with lymph node pathology. The sensitivity, specificity, positive predictive value, and negative predictive value were calculated for the detection of lymphadenopathy and peritoneal disease by PET/CT.
RESULTS


A total of 112 patients were enrolled and underwent PET/CT between April 2013 and May 2016, 108 of whom were evaluable. On PET/CT, 21 patients (19.4%) were found to have extrauterine disease, 18 (17%) had positive lymph nodes, and 8 (7%) had peritoneal disease. A total of 108 patients underwent surgery, 103 of whom (95%) underwent lymphadenectomy. The sensitivity of PET/CT to detect positive lymph nodes was 45.8%, with a specificity of 91.1%, positive predictive value of 61.1%, and negative predictive value of 84.7%. The false-negative rate was 54.2%. There was no difference in primary tumor characteristics on imaging noted between patients with positive and negative lymph nodes. The sensitivity of PET/CT to detect peritoneal disease was 37.5%, with a specificity of 97.8%, positive predictive value of 75%, and negative predictive value of 90.0%. The false-negative rate was 62.5%.
CONCLUSIONS


Preoperative PET/CT did not reliably predict the presence of extrauterine disease in women with high-risk endometrial cancer. Given the high false-negative rates, PET/CT should not be used in the preoperative treatment planning of these patients.",2019,"The sensitivity of PET/CT to detect peritoneal disease was 37.5%, with a specificity of 97.8%, positive predictive value of 75%, and negative predictive value of 90.0%.","['108 patients underwent surgery, 103 of whom (95%) underwent', 'patients with high-risk endometrial cancer', 'patients with newly diagnosed high-risk endometrial cancer', 'Women with high-risk endometrial cancer', '112 patients were enrolled and underwent PET/CT between April 2013 and May 2016, 108 of whom were evaluable', 'women with high-risk endometrial cancer']","['preoperative PET/CT followed by surgery, including sentinel lymph node biopsy and lymphadenectomy', 'lymphadenectomy', 'preoperative positron emission tomography (PET)/computed tomography (CT', 'Preoperative PET/CT']","['peritoneal disease', 'sensitivity, specificity, positive predictive value, and negative predictive value', 'sensitivity of PET/CT to detect peritoneal disease', 'sensitivity of PET/CT to detect positive lymph nodes', 'false-negative rate', 'positive lymph nodes']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0032744', 'cui_str': 'Positive beta particle'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}]","[{'cui': 'C0031142', 'cui_str': 'Disorder of peritoneum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0205558', 'cui_str': 'False negative'}]",112.0,0.0352586,"The sensitivity of PET/CT to detect peritoneal disease was 37.5%, with a specificity of 97.8%, positive predictive value of 75%, and negative predictive value of 90.0%.","[{'ForeName': 'Katherine I', 'Initials': 'KI', 'LastName': 'Stewart', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Chasen', 'Affiliation': 'Department of Nuclear Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Erwin', 'Affiliation': 'Department of Imaging Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Fleming', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Westin', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Shayan', 'Initials': 'S', 'LastName': 'Dioun', 'Affiliation': 'Department of Obstetrics and Gynecology, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Frumovitz', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Ramirez', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Lu', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Franklin', 'Initials': 'F', 'LastName': 'Wong', 'Affiliation': 'Department of Nuclear Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Aloia', 'Affiliation': 'Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Pamela T', 'Initials': 'PT', 'LastName': 'Soliman', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Cancer,['10.1002/cncr.32329']
3352,30928678,"Study of the association of DHEAS, testosterone and cortisol with S-Klotho plasma levels in healthy sedentary middle-aged adults.","BACKGROUND


α-Klotho is a recently discovered gene that accelerates ageing when disrupted and extends lifespan when overexpressed. The age-related decline in DHEAS and testosterone secretion and the increase in cortisol are associated with a rise of frailty and mortality.
OBJECTIVE


To investigate the association of DHEAS, cortisol and testosterone plasma levels with S-Klotho plasma levels in healthy sedentary middle-aged adults.
METHODS


73 (39 women) healthy middle-aged sedentary adults (45-65 years old) were recruited for the present study. The blood samples were collected in the morning after fasting for 12 h.
RESULTS


DHEAS was positively associated with S-Klotho in men (β = 0.521, R 2  = 0.248, P = 0.002), whereas no association was observed in women (P ≥ 0.201). Testosterone was positively associated with S-Klotho in both men and women (β = 0.360, R 2  = 0.099, P = 0.047; β = 0.431, R 2  = 0.161, P = 0.010, respectively). No association was found between cortisol and S-Klotho neither in men nor in women (all P ≥ 0.141). The association between DHEAS and testosterone with S-Klotho in men disappeared after adjusting by age (all P ≥ 0.151). Nevertheless, the association between testosterone (β = 0.397, R 2  = 0.423, P = 0.011) and S-Klotho in women remained after adjusting by age.
CONCLUSIONS


DHEAS and testosterone were positively associated with S-Klotho in healthy sedentary middle-aged men while only testosterone was positively associated in women.",2019,No association was found between cortisol and S-Klotho neither in men nor in women (all P ≥ 0.141).,"['73 (39 women) healthy middle-aged sedentary adults (45-65\u202fyears old', 'healthy sedentary middle-aged men', 'healthy sedentary middle-aged adults']","['DHEAS, testosterone and cortisol with S-Klotho plasma levels']","['DHEAS, cortisol and testosterone plasma levels', 'cortisol and S-Klotho', 'blood samples', 'Testosterone']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1144173', 'cui_str': 'KL protein, human'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1144173', 'cui_str': 'KL protein, human'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",73.0,0.0360881,No association was found between cortisol and S-Klotho neither in men nor in women (all P ≥ 0.141).,"[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Dote-Montero', 'Affiliation': 'Department of Medical Physiology, School of Medicine, University of Granada, 18016 Granada, Spain. Electronic address: manueldote@correo.ugr.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Amaro-Gahete', 'Affiliation': 'Department of Medical Physiology, School of Medicine, University of Granada, 18016 Granada, Spain. Electronic address: amarof@ugr.es.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'De-la-O', 'Affiliation': 'Department of Medical Physiology, School of Medicine, University of Granada, 18016 Granada, Spain.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Jurado-Fasoli', 'Affiliation': 'Department of Medical Physiology, School of Medicine, University of Granada, 18016 Granada, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Gutierrez', 'Affiliation': 'Department of Medical Physiology, School of Medicine, University of Granada, 18016 Granada, Spain.'}, {'ForeName': 'Manuel J', 'Initials': 'MJ', 'LastName': 'Castillo', 'Affiliation': 'Department of Medical Physiology, School of Medicine, University of Granada, 18016 Granada, Spain.'}]",Experimental gerontology,['10.1016/j.exger.2019.03.010']
3353,32320482,Using Healthcare Databases to Replicate Trial Findings for Supplemental Indications: Adalimumab in Patients with Ulcerative Colitis.,"Regulators wish to understand whether real world evidence can be used for secondary indications of biologics. Using the secondary indication of adalimumab for ulcerative colitis (UC) as an example, we aimed to replicate the ULTRA-2 randomized controlled trial finding on the effectiveness of adalimumab in patients with UC using realworld data analyses. Adalimumab, a TNF-alpha receptor inhibitor initially approved for Crohn's disease, was approved for moderate to severe UC in 2012. The ULTRA-2 trial had shown improved remission against placebo in patients with UC. Using claims data (2006-2012), we conducted a cohort study of patients with UC who initiated adalimumab and compared them with (i) nonusers and (ii) new users of infliximab using propensity score matching. The coprimary end points were corticosteroid (CS) discontinuation within 8 weeks and 1 year of treatment. We computed hazard ratios (HRs) and 95% confidence intervals (CIs). We identified 398 matched pairs of adalimumab users vs. nonusers and 326 pairs of adalimumab vs. infliximab users. Adalimumab users were 28% more likely to achieve CS-discontinuation compared with nonusers over 1 year (HR = 1.28; 95% CI 0.94-1.73). However, unlike in ULTRA-2, this effect was not observed in the first 8 weeks (HR = 0.79; 95% CI 0.65-0.97). Compared with infliximab, adalimumab initiators showed no incremental benefit over 1 year (HR = 1.08; 95% CI 0.80-1.04), but showed a 22% reduction (HR = 0.78; 95% CI 0.64-0.95) during the first 8 weeks of treatment. In summary, our results highlight opportunities and some limitations of database analysis to identify treatment effects for secondary indications.",2020,"Compared with infliximab, adalimumab initiators showed no incremental benefit over 1 year (HR = 1.08; 95% CI 0.80-1.04), but showed a 22% reduction (HR = 0.78; 95% CI 0.64-0.95) during the first 8 weeks of treatment.","['398 matched pairs of adalimumab users vs. nonusers and 326 pairs of adalimumab vs. infliximab users', 'patients with UC who initiated adalimumab and compared them with (i) nonusers and (ii) new users of', 'ulcerative colitis (UC', 'patients with UC using realworld data analyses', 'Patients with Ulcerative Colitis', 'patients with UC']","['adalimumab', 'Adalimumab', 'infliximab', 'infliximab, adalimumab', 'placebo']","['CS-discontinuation', 'corticosteroid (CS) discontinuation']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.17633,"Compared with infliximab, adalimumab initiators showed no incremental benefit over 1 year (HR = 1.08; 95% CI 0.80-1.04), but showed a 22% reduction (HR = 0.78; 95% CI 0.64-0.95) during the first 8 weeks of treatment.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Spoendlin', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Rishi J', 'Initials': 'RJ', 'LastName': 'Desai', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Franklin', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Payne', 'Affiliation': 'Aetion Inc., Boston, Massachusetts, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schneeweiss', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1861']
3354,32445557,Compression of Myofascial Trigger Points With a Foam Roller or Ball for Exercise-induced Anterior Knee Pain: A Randomized Controlled Trial.,"Objective


The study aimed to evaluate the effectiveness of compression of myofascial trigger points (MTrPs) with a foam roller or ball, combined with static stretching of knee muscles, on exercise-induced, anterior knee pain in fitness runners.
Design


The research team designed a randomized controlled trial.
Setting


The study took place in the Department of Sports Medicine and Rehabilitation Center of the School of Kinesiology at Shanghai University of Sport in Shanghai, China.
Participants


A total of 80 participants, 28 males and 52 females with an average age of 37.2 ± 2.9 years, were recruited at the center.
Intervention


The participants were randomly assigned to one of 4 groups, with 20 participants in each group: (1) the MG+SG group, which received compression with a foam roller or ball (MG) and static stretching (SG); (2) the MG group, which received compression only; (3) the SG group static, which received static stretching only; or (4) the control group (CG), which attended a 30-min class about nutrition or exercise once a month and received no intervention. For the MG intervention, participants' MTrPs were compressed with a foam roller or ball for 30 minutes once every 5 days for 2 months. After each compression, the MG+SG group received static stretching immediately.
Outcome Measures


A visual analog scale (VAS) and a participant's range of motion (ROM) of the knee were assessed at baseline, after 4 weeks of the intervention, immediately postintervention, and at a follow-up at 8 weeks postintervention. The effectiveness of the treatment in the different groups was also compared.
Results


Immediately postintervention, 18 participants (90%) in MG+SG group, 12 (60%) in MG group, and 8 (40%) in the SG group were pain free. Compared with those at baseline, the VAS scores of the MG+SG group significantly improved between baseline and postintervention and were unchanged at the eight-week follow-up. In all groups, the VAS scores and ROMs of the knee increased, but only the MG+SG group's values increased significantly.
Conclusions


Compression of MTrPs with a foam roller or ball, combined with static stretching, was more effective than either the compression only or static stretching only.",2020,"In all groups, the VAS scores and ROMs of the knee increased, but only the MG+SG group's values increased significantly.
","['induced Anterior Knee Pain', 'Participants\n\n\nA total of 80 participants, 28 males and 52 females with an average age of 37.2 ± 2.9 years, were recruited at the center', 'fitness runners', 'Department of Sports Medicine and Rehabilitation Center of the School of Kinesiology at Shanghai University of Sport in Shanghai, China']","['MG+SG', 'MG+SG group, which received compression with a foam roller or ball (MG) and static stretching (SG); (2) the MG group, which received compression only; (3) the SG group static, which received static stretching only; or (4) the control group (CG), which attended a 30-min class about nutrition or exercise once a month and received no intervention', 'compression of myofascial trigger points (MTrPs) with a foam roller or ball, combined with static stretching of knee muscles', 'Foam Roller or Ball for Exercise', 'static stretching immediately']","['VAS scores and ROMs of the knee', ""visual analog scale (VAS) and a participant's range of motion (ROM) of the knee"", 'pain free', 'VAS scores']","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}]",80.0,0.0309948,"In all groups, the VAS scores and ROMs of the knee increased, but only the MG+SG group's values increased significantly.
","[{'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Fujun', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Qiangmin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Opoku Antwi', 'Affiliation': ''}, {'ForeName': 'Thitham', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
3355,32445558,Effect of Electroacupuncture on Postoperative Gastrointestinal Recovery in Patients Undergoing Thoracoscopic Surgery: A Feasibility Study.,"BACKGROUND The aim of this study was to study the feasibility and acceptability of electroacupuncture (EA) for preventing postoperative gastrointestinal complications in patients undergoing thoracoscopic segmentectomy/lobectomy. MATERIAL AND METHODS Sixty patients who underwent video-assisted thoracoscopic (VATS) segmentectomy/lobectomy received either EA treatments plus usual care (EA group) or usual care alone (UC group). Patients in the EA group were given 30 minutes of bilateral electroacupuncture on 3 acupoints [Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37)] at 3 time points (24 hours before surgery, and 4 hours and 24 hours after surgery). The primary outcomes were recruitment, retention, acceptability of the EA intervention, incidence and severity of abdominal distension (AD), and time to first flatus and defecation. Secondary outcomes included postoperative nausea and vomiting (PONV), pain intensity, and duration of hospital stay. RESULTS We recruited 60 participants and 59 were randomized into 2 groups for this study: 30 in the EA group and 29 in the UC group. In total, 57 participants completed the study. With the exception of one participant in the EA group, all participants completed all three sessions of EA. The one exclusion was a case where a paravertebral block was not used during the surgery. Qualitative findings from the acceptability questionnaire indicated that participants viewed the EA treatment as acceptable. After EA treatment, there was a small but statistically significant improvement in participants' acceptance of EA for alleviating postoperative gastrointestinal discomfort (P=0.001). The EA group showed improved outcomes compared to the UC group in terms of time to first flatus (20.8±4.6 versus 24.1±6.2 hours, P=0.026) and defecation (53.9±6.0 versus 57.5±7.2 hours, P=0.046). No significant differences appeared regarding AD, rescue medication, or duration of hospitalization. PONV and pain intensity were similar in both groups at the recorded time periods. CONCLUSIONS EA is feasible and acceptable to patients undergoing VATS surgery. Our preliminary findings of EA promoting postoperative recovery of gastrointestinal function warrants large randomized controlled trials.",2020,"After EA treatment, there was a small but statistically significant improvement in participants' acceptance of EA for alleviating postoperative gastrointestinal discomfort (P=0.001).","['57 participants completed the study', 'Sixty patients who underwent', '60 participants and 59 were randomized into 2 groups for this study: 30 in the EA group and 29 in the UC group', 'patients undergoing VATS surgery', 'patients undergoing thoracoscopic segmentectomy/lobectomy', 'Patients Undergoing Thoracoscopic Surgery']","['electroacupuncture (EA', 'Electroacupuncture', 'bilateral electroacupuncture on 3 acupoints [Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37', 'EA', 'video-assisted thoracoscopic (VATS) segmentectomy/lobectomy received either EA treatments plus usual care (EA group) or usual care alone (UC group']","['time to first flatus', 'PONV and pain intensity', 'postoperative nausea and vomiting (PONV), pain intensity, and duration of hospital stay', 'defecation', 'recruitment, retention, acceptability of the EA intervention, incidence and severity of abdominal distension (AD), and time to first flatus and defecation', 'AD, rescue medication, or duration of hospitalization', 'Postoperative Gastrointestinal Recovery', ""participants' acceptance of EA for alleviating postoperative gastrointestinal discomfort"", 'postoperative gastrointestinal complications']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0024885', 'cui_str': 'Partial mastectomy'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0450534', 'cui_str': 'ST37'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0024885', 'cui_str': 'Partial mastectomy'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0161819', 'cui_str': 'Gastrointestinal complication'}]",60.0,0.0873528,"After EA treatment, there was a small but statistically significant improvement in participants' acceptance of EA for alleviating postoperative gastrointestinal discomfort (P=0.001).","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Libing', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Siying', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Wenzhong', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Acupuncture and Rehabilitation, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Weiqian', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'School of Health and Biomedical Sciences, Royal Melbourne Institute of Technology (RMIT) University, Melbourne, Australia.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Lv', 'Affiliation': 'Department of Pharmacology, Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Fangbing', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.920648']
3356,32445609,Dependency of respiratory system mechanics on positive end-expiratory pressure and recruitment maneuvers in lung healthy pediatric patients - a randomized crossover study.,"BACKGROUND


The lungs of pediatric patients are subjected to tidal derecruitment during mechanical ventilation and in contrast to adult patients this unfavorable condition cannot be resolved with small positive end-expiratory pressure increases. This raises the question if higher end-expiratory pressure increases or recruitment maneuvers may resolve tidal derecruitment in pediatric patients.
AIMS


We hypothesized that higher positive end-expiratory pressure resolves tidal derecruitment in pediatric patients and that recruitment maneuvers between the pressure changes support the improvement of respiratory system mechanics.
METHODS


The effects of end-expiratory pressure changes from 3 to 7 cm H 2  O and vice versa without and with intermediate recruitment maneuvers on respiratory system mechanics and regional ventilation were investigated in 57 mechanically ventilated pediatric patients. The intratidal respiratory system compliance was determined from volume and pressure data before and after PEEP changes and categorized to indicate tidal derecruitment.
RESULTS


Tidal derecruitment occurred comparably frequently at positive end-expiratory pressure 3 cmH 2  O without (13 out of 14 cases) and with recruitment maneuver (14 out of 14 cases) and at positive end-expiratory pressure 7 cmH 2  O without (13 out of 14 cases) and with recruitment maneuver (13 out of 15 cases).
CONCLUSIONS


We conclude that contrary to our hypothesis, positive end-expiratory pressure up to 7 cm H 2  O is not sufficient to resolve tidal derecruitment and that recruitment maneuvers may be dispensable in mechanically ventilated pediatric patients.",2020,The effects of end-expiratory pressure changes from 3 to 7 cm H 2  O and vice versa without and with intermediate recruitment maneuvers on respiratory system mechanics and regional ventilation were investigated in 57 mechanically ventilated pediatric patients.,"['mechanically ventilated pediatric patients', 'lung healthy pediatric patients', 'pediatric patients', '57 mechanically ventilated pediatric patients']",['end-expiratory pressure changes from 3 to 7 cm\xa0H 2  O and vice versa without and with intermediate recruitment maneuvers'],"['respiratory system mechanics and regional ventilation', 'Tidal derecruitment']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0428720', 'cui_str': 'End-expiratory pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",57.0,0.0716177,The effects of end-expiratory pressure changes from 3 to 7 cm H 2  O and vice versa without and with intermediate recruitment maneuvers on respiratory system mechanics and regional ventilation were investigated in 57 mechanically ventilated pediatric patients.,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schumann', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Feth', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Borgmann', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Wirth', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}]",Paediatric anaesthesia,['10.1111/pan.13927']
3357,32446170,"Independent and combined effect of home-based progressive resistance training and nutritional supplementation on muscle strength, muscle mass and physical function in dynapenic older adults with low protein intake: A randomized controlled trial.","BACKGROUND


With the aging phenomenon, there is growing interest in developing effective strategies to counteract dynapenia, the age-related loss of muscle strength. The positive effect of progressive resistance training on muscle strength is well known, however, the effect of nutritional supplementation or its synergistic effect along with exercise on muscle strength is not a consensus in the literature, especially in populations with low protein intake.
METHODS


We analyzed the muscle strength (handgrip strength and sit-to-stand test), muscle mass, body mass index, insulin resistance, and physical function (gait speed, timed up & go test, and single-leg-stance test) of 69 dynapenic older adults with low protein intake, before and after the intervention period of three months. The participants were randomly allocated into four groups: resistance training, supplementation, resistance training plus supplementation, and control.
RESULTS


There was a significant group x time interaction on the following outcome measures: handgrip strength (p <  0.001), gait speed (p =  0.023), and sit-to-stand test (p <  0.001). Considering the outcomes that showed a significant difference between and within groups, only the resistance training group and the resistance training plus supplementation group showed a large effect size in handgrip strength, gait speed, and sit-to-stand test, whereas the supplementation group showed a moderate effect size in gait speed. After the intervention period, there was no difference between the resistance training and the resistance training plus supplementation groups.
CONCLUSION


This study reinforces the value of resistance training in improving muscle strength. The nutritional supplementation added no further benefits in this specific population. Registration number at the Brazilian registry of clinical trials: RBR-4HRQJF.",2020,"There was a significant group x time interaction on the following outcome measures: handgrip strength (p <  0.001), gait speed (p =  0.023), and sit-to-stand test (","['dynapenic older adults with low protein intake', '69 dynapenic older adults with low protein intake, before and after the intervention period of three months']","['home-based progressive resistance training and nutritional supplementation', 'progressive resistance training', 'resistance training, supplementation, resistance training plus supplementation, and control']","['muscle strength (handgrip strength and sit-to-stand test), muscle mass, body mass index, insulin resistance, and physical function (gait speed, timed up & go test, and single-leg-stance test', 'gait speed', 'sit-to-stand test ', 'muscle strength, muscle mass and physical function', 'handgrip strength', 'moderate effect size in gait speed', 'handgrip strength, gait speed, and sit-to-stand test']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0382378,"There was a significant group x time interaction on the following outcome measures: handgrip strength (p <  0.001), gait speed (p =  0.023), and sit-to-stand test (","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'de Carvalho Bastone', 'Affiliation': 'Postgraduate Program in Reabilitation and Functional Performance, Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: ale.bastone@gmail.com.'}, {'ForeName': 'Luciana Neri', 'Initials': 'LN', 'LastName': 'Nobre', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: lunerinobre@yahoo.com.br.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'de Souza Moreira', 'Affiliation': 'Postgraduate Program in Public Health - Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil. Electronic address: onurbsm@yahoo.com.br.'}, {'ForeName': 'Iramaya Francielle', 'Initials': 'IF', 'LastName': 'Rosa', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: iramayafranciellerosa@hotmail.com.'}, {'ForeName': 'Gabrielle Bemfica', 'Initials': 'GB', 'LastName': 'Ferreira', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: gabi_bferreira@hotmail.com.'}, {'ForeName': 'Dayane Deyse Lee', 'Initials': 'DDL', 'LastName': 'Santos', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: dayanedls@hotmail.com.'}, {'ForeName': 'Nancy Krysna Sancha Silva', 'Initials': 'NKSS', 'LastName': 'Monteiro', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: krysnancymonteiro@gmail.com.'}, {'ForeName': 'Michelle Dullya', 'Initials': 'MD', 'LastName': 'Alves', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: mih.dullya@gmail.com.'}, {'ForeName': 'Rômulo Amaral', 'Initials': 'RA', 'LastName': 'Gandra', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: romulogandra@yahoo.com.br.'}, {'ForeName': 'Elane Marinho', 'Initials': 'EM', 'LastName': 'de Lira', 'Affiliation': 'Postgraduate Program in Reabilitation and Functional Performance, Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: e.lira.fisio@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104098']
3358,32446172,Effects of 'participatory group-based care management' on wellbeing of older people living alone: a randomized controlled trial.,"BACKGROUND AND OBJECTIVES


More knowledge is needed of the effectiveness of complex interventions that aim to promote the wellbeing of older people. This study examines the effects of 'participatory group-based care management' conducted among community-dwelling older adults living alone in Central and Eastern Finland. The intervention aimed to promote wellbeing and quality of life (QoL) using a needs-based and participatory approach.
METHODS


The study was carried out as a randomized control trial (intervention group n = 185, control group n = 207). In this article, baseline and 6-month follow-up surveys were used. QoL (WHOQOL-Bref instrument), loneliness (Revised UCLA Loneliness Scale; single-item question), and trust (two items of generalized trust and six items of institutional trust) were used as outcome measurements, and generalized estimating equations (GEE) modeling as the analysis method. Both per-protocol and intention-to-treat analyses were applied.
RESULTS


According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline. Additionally, the intervention enhanced trust in other people and some dimensions of institutional trust. The intention-to-treat analysis did not result in any significant effects on QoL or loneliness, but some small positive changes in institutional trust were found.
CONCLUSIONS


Based on some evidence of small positive effects, the intervention may be beneficial in alleviating loneliness and enhancing trust among older people living alone. Because of the contradictory results, more research is needed to examine the complexity of 'participatory group-based care management´ from the perspective of process evaluation.",2020,"According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline.","['older people', 'community-dwelling older adults living alone in Central and Eastern Finland', 'older people living alone']",['participatory group-based care management'],"['QoL or loneliness', 'wellbeing and quality of life (QoL', 'QoL. Loneliness', 'QoL (WHOQOL-Bref instrument), loneliness (Revised UCLA Loneliness Scale; single-item question), and trust (two items of generalized trust and six items of institutional trust']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439044', 'cui_str': 'Lives alone'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0856593,"According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline.","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Ristolainen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Kannasoja', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Tiilikainen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hakala', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Närhi', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Rissanen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104095']
3359,32446176,"Efficacy and safety of safinamide as an add-on therapy to L-DOPA for patients with Parkinson's disease: A randomized, double-blind, placebo-controlled, phase II/III study.","INTRODUCTION


Safinamide is a reversible and selective monoamine oxidase-B (MAO-B) and sodium channel inhibitor with demonstrated efficacy in mid-to late-stage Parkinson's disease (PD) as an adjunct to l-DOPA. This study aimed to confirm the efficacy and safety of safinamide in PD patients with wearing-off.
METHODS


This 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study included Japanese PD patients with wearing-off on l-DOPA treatment. Patients were randomized to receive placebo (P), safinamide 50 mg/day (S50), or safinamide 100 mg/day (S100). The primary endpoint was the change from baseline in mean daily ON-time without troublesome dyskinesias (ON-time). Other measures included the changes in mean daily OFF-time, the unified Parkinson's disease rating scale (UPDRS) score, and the PDQ-39 summary index.
RESULTS


A total of 406 subjects were randomized, of whom 349 completed the study. Baseline characteristics were balanced. Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group. Changes from baseline in mean daily OFF-time, UPDRS Part II total score (OFF phase), UPDRS Part III total score (ON phase), and UPDRS Part I also showed significant improvements. Adverse events occurred in 58.9%, 60.2%, and 61.4% of the P, S50, and S100 groups, respectively. The most common adverse drug reactions were dyskinesias (2.1%, 8.3%, and 10.6%) and visual hallucinations (1.4%, 3.0%, and 4.5%).
CONCLUSION


As an adjunct to l-DOPA, safinamide safely increased ON-time and improved PD symptoms/signs in PD patients with wearing-off.",2020,Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group.,"[""patients with Parkinson's disease"", 'PD patients with wearing-off', 'Japanese PD patients with wearing-off on l-DOPA treatment', 'A total of 406 subjects were randomized, of whom 349 completed the study']","['sodium channel inhibitor', 'safinamide', 'placebo (P), safinamide 50\xa0mg/day (S50), or safinamide 100\xa0mg/day (S100', 'placebo']","['Adverse events', 'dyskinesias', 'Efficacy and safety', 'mean daily OFF-time, UPDRS Part II total score (OFF phase), UPDRS Part III total score (ON phase), and UPDRS Part', 'visual hallucinations', 'mean daily ON-time', 'efficacy and safety', ""mean daily OFF-time, the unified Parkinson's disease rating scale (UPDRS) score, and the PDQ-39 summary index"", 'change from baseline in mean daily ON-time without troublesome dyskinesias (ON-time', 'ON-time and improved PD symptoms/signs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0872271', 'cui_str': 'Sodium channel blocker'}, {'cui': 'C1098261', 'cui_str': 'safinamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4475891', 'cui_str': 'safinamide 50 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4475900', 'cui_str': 'safinamide 100 MG'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0233763', 'cui_str': 'Visual hallucinations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",406.0,0.175291,Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group.,"[{'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan. Electronic address: nhattori@juntendo.ac.jp.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan. Electronic address: tsuboi@cis.fukuoka-u.ac.jp.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Meiji Seika Pharma Co., Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, 104-8002, Japan. Electronic address: akihiko.yamamoto@meiji.com.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Sasagawa', 'Affiliation': 'Meiji Seika Pharma Co., Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, 104-8002, Japan. Electronic address: yuuji.sasagawa@meiji.com.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Graduate School of Medicine, Ehime University, Shizugawa, Tohon, Ehime, 791-0295, Japan; Saiseikai Imabari Center for Health and Welfare, 7-6-1 Kitamura, Imabari, Ehime, 799-1592, Japan. Electronic address: nomoto@m.ehime-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.04.012']
3360,32446208,Absence seizure provocation during routine EEG: Does position of the child during hyperventilation affect the diagnostic yield?,"PURPOSE


When performed correctly, hyperventilation (HV) for three minutes provokes absence seizures in virtually all children, a finding suggestive of a diagnosis of childhood absence epilepsy (CAE). Interestingly, some children experience absence seizures while performing HV in the office yet do not experience absences during HV on subsequent routine EEG. In most instances, HV during routine EEG is performed in the supine position, while in the office HV is done with the child sitting-up. Therefore, we hypothesized that the position in which HV is performed may influence its yield in provoking absence seizures.
METHODS


We conducted a randomized multi-center controlled trial among children (4-10 years old) with suspected CAE. During a routine EEG, children were asked to perform HV twice, in the supine and sitting positions.
RESULTS


Twenty children (four males) diagnosed with CAE were included in the analysis. Seventeen of the 20 patients experienced absence seizures while sitting and 13 experienced seizures during supine HV (p = 0.031). All patients that had absence seizures during supine HV also had seizures during sitting HV. Among patients with absences in both positions, seizure duration was significantly shorter during sitting HV (mean 8.69 seconds) than during supine HV (mean 12 seconds) (p = 0.042). An opposite tendency was seen in the younger age group (4-7 years), with shorter seizures in the supine HV group (5.6 seconds supine, 7.57 seconds sitting, p = 0.019).
CONCLUSIONS


HV in the sitting position may increase the yield of provoking absence seizures during routine EEGs, thereby improving its sensitivity in the diagnosis of CAE.",2020,"Among patients with absences in both positions, seizure duration was significantly shorter during sitting HV (mean 8.69 seconds) than during supine HV (mean 12 seconds) (p = 0.042).","['children (4-10 years old) with suspected CAE', 'Twenty children (four males) diagnosed with CAE']",['routine EEG'],"['sitting HV', 'seizure duration', 'shorter seizures', 'absence seizures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0014553', 'cui_str': 'Absence seizure'}]",20.0,0.0300237,"Among patients with absences in both positions, seizure duration was significantly shorter during sitting HV (mean 8.69 seconds) than during supine HV (mean 12 seconds) (p = 0.042).","[{'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Rozenblat', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: tal.hakim@gmail.com.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Kraus', 'Affiliation': ""Department of Neurology, Schneider Children's Medical Center of Israel, Petah Tiqva, Israel. Electronic address: Kraus.dror@gmail.com.""}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Mahajnah', 'Affiliation': 'Institute, Hillel Yaffe Medical Center, The Ruth and Bruce Rappaport Faculty of medicine, Technion University, Israel. Electronic address: MohamedM@hy.health.gov.il.'}, {'ForeName': 'Hadassah', 'Initials': 'H', 'LastName': 'Goldberg-Stern', 'Affiliation': ""Department of Neurology, Schneider Children's Medical Center of Israel, Petah Tiqva, Israel. Electronic address: Hagoldberg@clalit.org.il.""}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Watemberg', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: watembergn@walla.co.il.'}]",Seizure,['10.1016/j.seizure.2020.03.013']
3361,32446245,"Me, myself, bye: regional alterations in glutamate and the experience of ego dissolution with psilocybin.","There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression. Accumulating preclinical evidence emphasizes the role of the glutamate system in the acute action of the drug on brain and behavior; however this has never been tested in humans. Following a double-blind, placebo-controlled, parallel group design, we utilized an ultra-high field multimodal brain imaging approach and demonstrated that psilocybin (0.17 mg/kg) induced region-dependent alterations in glutamate, which predicted distortions in the subjective experience of one's self (ego dissolution). Whereas higher levels of medial prefrontal cortical glutamate were associated with negatively experienced ego dissolution, lower levels in hippocampal glutamate were associated with positively experienced ego dissolution. Such findings provide further insights into the underlying neurobiological mechanisms of the psychedelic, as well as the baseline, state. Importantly, they may also provide a neurochemical basis for therapeutic effects as witnessed in ongoing clinical trials.",2020,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.",[],"['psilocybin', 'placebo']","['medial prefrontal cortical glutamate', 'hippocampal glutamate']",[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}]",,0.0862072,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.","[{'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. natasha.mason@maastrichtuniversity.nl.'}, {'ForeName': 'K P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reckweg', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'D H Y', 'Initials': 'DHY', 'LastName': 'Tse', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': 'Institute of Legal Medicine, University of Frankfurt, Kennedyallee 104, D-60596, Frankfurt/Main, Germany.'}, {'ForeName': 'N R P W', 'Initials': 'NRPW', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J F A', 'Initials': 'JFA', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+ (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stiers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, Oxford, OX3 9SY, UK.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. j.ramaekers@maastrichtuniversity.nl.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0718-8']
3362,32446280,Does performance-based financing curb stock-outs of essential medicines? Results from a randomised controlled trial in Cameroon.,"OBJECTIVE


In 2011, the government of Cameroon launched its performance-based financing (PBF) scheme. Our study examined the effects of the PBF intervention on the availability of essential medicines (EM).
METHODS


Randomized control trial whereby PBF and three distinct comparison groups were randomized in a total of 205 health facilities across three regions. Baseline data were collected between March and May 2012 and endline data 36 months later. We defined availability of multiple EM groups by assessing stock-outs for at least one day over the 30 days prior to the survey date and estimated changes attributable to PBF using a series of difference-in-difference regression models, adjusted for relevant facility-level co-variates. Data were analysed stratified by region and area to assess effect heterogeneity.
RESULTS


Our estimates suggest that PBF intervention had no effect on the stock-outs of antenatal care drugs (p=0.160), vaccines (p=0.396), integrated management of childhood illness drugs (p=0.681) and labour and delivery drugs (p=0.589). However, the intervention was associated with a significant reduction of 34% in stock-outs of family planning medicines (p = 0.028). We observed effect heterogeneity across regions and areas, with significant decreases in stock-outs of family planning products in North-West region (p = 0.065) and in rural areas (p = 0.043).
CONCLUSIONS


The PBF intervention in Cameroon had limited effects on the reduction of EMs stock-outs. These poor results were likely the consequence of partial implementation failure, ranging from disruption and discontinuation of services to limited facility autonomy in managing decision-making and considerable delay in performance payment.",2020,"We observed effect heterogeneity across regions and areas, with significant decreases in stock-outs of family planning products in North-West region (p = 0.065) and in rural areas (p = 0.043).
",['205 health facilities across three regions'],"['PBF intervention', 'PBF']","['stock-outs of antenatal care drugs', 'stock-outs of family planning products']","[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243097', 'cui_str': 'financing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0453908', 'cui_str': 'Stocking'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}]",,0.070051,"We observed effect heterogeneity across regions and areas, with significant decreases in stock-outs of family planning products in North-West region (p = 0.065) and in rural areas (p = 0.043).
","[{'ForeName': 'Isidore', 'Initials': 'I', 'LastName': 'Sieleunou', 'Affiliation': 'University of Montreal Public Health Research Institute, Montreal, Canada.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'De Allegri', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Roland Enok Bonong', 'Affiliation': 'School of Public Health, University of Montreal, Montreal, Canada.'}, {'ForeName': 'Samiratou', 'Initials': 'S', 'LastName': 'Ouédraogo', 'Affiliation': 'Institut National de Santé Publique du Québec, Montréal, Canada.'}, {'ForeName': 'Valéry', 'Initials': 'V', 'LastName': 'Ridde', 'Affiliation': 'School of Public Health, University of Montreal, Montreal, Canada.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13447']
3363,30471264,Predictors of postabortion contraception use in Cambodia.,"OBJECTIVE


To evaluate which characteristics collected at the point of abortion are associated with contraceptive use over the extended postabortion period for women in Cambodia.
METHODS


The study includes a cohort of 500 women who attended a Marie Stopes International Cambodia clinic for an induced abortion. The primary outcomes are use of effective contraception ≥80% of the time over the 4- and 12-month period postabortion. We conducted a bivariate analysis to assess the association between each characteristic and the outcome, followed by multivariable modeling to identify the strongest predictors of the outcomes.
RESULTS


Nearly 44% of the women used contraception for more than 80% of the time during both follow-up periods. Several sociodemographic and reproductive factors were crudely associated with the outcomes. In the multivariable model, prior use of contraception, intention to use postabortion contraception, increased number of children and medical abortion were associated with increased contraceptive use over the year postabortion. Occupation was a predictor at 4 months only, and abortion method was a predictor at 12 months only.
CONCLUSIONS


The models were satisfactory in predicting the outcome of contraceptive continuation both at 4 and 12 months. The paper sets out a methodology for modeling these predictors that can help inform more client-centered counseling and services for women.
IMPLICATIONS


Factors known when attending a clinic for induced abortion can help inform more targeted and client-centered postabortion family planning counseling and services for women in Cambodia.",2019,The models were satisfactory in predicting the outcome of contraceptive continuation both at 4 and 12 months.,"['women in Cambodia', '500 women who attended a Marie Stopes International Cambodia clinic for an induced abortion']",[],"['number of children and medical abortion', 'effective contraception ≥80% of the time over the 4- and 12-month period postabortion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006797', 'cui_str': 'Cambodia'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032753', 'cui_str': 'Postabortion'}]",500.0,0.0368537,The models were satisfactory in predicting the outcome of contraceptive continuation both at 4 and 12 months.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Adelman', 'Affiliation': 'London School of Hygiene and Tropical Medicine. Electronic address: sara.elan.adelman@gmail.com.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Free', 'Affiliation': 'London School of Hygiene and Tropical Medicine.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'London School of Hygiene and Tropical Medicine; School of Tropical Medicine and Global Health, Nagasaki University.'}]",Contraception,['10.1016/j.contraception.2018.11.010']
3364,32445440,Remdesivir for the Treatment of Covid-19 - Preliminary Report.,"BACKGROUND


Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), none have yet been shown to be efficacious.
METHODS


We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.
RESULTS


A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%).
CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACCT-1 ClinicalTrials.gov number, NCT04280705.).",2020,"CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","['1059 patients (538 assigned to remdesivir and 521 to', 'adults hospitalized with Covid-19 and evidence of lower respiratory tract infection', '1063 patients underwent randomization', 'adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement']","['remdesivir', 'intravenous remdesivir', 'placebo']","['median recovery time', 'time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0458579', 'cui_str': 'Lower respiratory tract structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1063.0,0.687871,"CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Tomashek', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Dodd', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Zingman', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Kalil', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hohmann', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Luetkemeyer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kline', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Lopez de Castilla', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Finberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Dierberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tapson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lanny', 'Initials': 'L', 'LastName': 'Hsieh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Patterson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Sweeney', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Short', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Giota', 'Initials': 'G', 'LastName': 'Touloumi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'David Chien', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ohmagari', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruiz-Palacios', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Fätkenheuer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Kortepeter', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'C Buddy', 'Initials': 'CB', 'LastName': 'Creech', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Abdel G', 'Initials': 'AG', 'LastName': 'Babiker', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Burgess', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Bonnett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Makowski', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Osinusi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nayak', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2007764']
3365,32445461,Cryoprecipitate Utilization Patterns Observed With a Required Prospective Approval Process vs Electronic Dosing Guidance.,"OBJECTIVES


We evaluated the impact of electronic medical record (EMR)-guided pooled cryoprecipitate dosing vs our previous practice of requiring transfusion medicine (TM) resident approval for every cryoprecipitate transfusion.
METHODS


At our hospital, cryoprecipitate pooled from five donors is dosed for adult patients, while single-donor cryoprecipitate is dosed for pediatric patients (defined as patients <50 kg in weight). EMR-based dosing guidance replaced a previously required TM consultation when cryoprecipitate pools were ordered, but a consultation remained required for single-unit orders. Usage was defined as thawed cryoprecipitate; wastage was defined as cryoprecipitate that expired prior to transfusion.
RESULTS


In the 6 months prior to intervention, 178 ± 13 doses of pooled cryoprecipitate were used per month vs 187 ± 15 doses after the intervention (P = .68). Wastage of pooled cryoprecipitate increased from 7.7% ± 1.5% to 12.7% ± 1.4% (P = .038). There was no change in wastage of pediatric cryoprecipitate doses during the study period. These trends remained unchanged for a full year postimplementation.
CONCLUSIONS


Electronic dosing guidance resulted in similar cryoprecipitate usage as TM auditing. Increased wastage may result from reduced TM oversight. Product wastage should be balanced against the possibility that real-time audits could delay a lifesaving therapy.",2020,Wastage of pooled cryoprecipitate increased from 7.7% ± 1.5% to 12.7% ± 1.4% (P = .038).,[],[],"['Wastage of pooled cryoprecipitate', 'wastage of pediatric cryoprecipitate doses']",[],[],"[{'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0443121', 'cui_str': 'Cryoprecipitate'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]",,0.035965,Wastage of pooled cryoprecipitate increased from 7.7% ± 1.5% to 12.7% ± 1.4% (P = .038).,"[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Kruse', 'Affiliation': 'Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Neally', 'Affiliation': 'Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Parvez M', 'Initials': 'PM', 'LastName': 'Lokhandwala', 'Affiliation': 'Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ness', 'Affiliation': 'Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Frank', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Aaron A R', 'Initials': 'AAR', 'LastName': 'Tobian', 'Affiliation': 'Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Gehrie', 'Affiliation': 'Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}]",American journal of clinical pathology,['10.1093/ajcp/aqaa042']
3366,32445474,Impact of intrapartum oral azithromycin on the acquired macrolide resistome of infants' nasopharynx: a randomised controlled trial.,"In a post-hoc analysis of samples from an intra-partum azithromycin randomized-clinical-trial, we found that children whose mothers had been treated with the drug had higher prevalence of macrolide resistance genes msr(A) and ermC at 28 days but not at 12 months. The two genes were positively associated in the nasopharynx.",2020,The two genes were positively associated in the nasopharynx.,"[""infants' nasopharynx""]",['intrapartum oral azithromycin'],[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}]","[{'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]",[],,0.155401,The two genes were positively associated in the nasopharynx.,"[{'ForeName': 'Abdoulie', 'Initials': 'A', 'LastName': 'Bojang', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Baines', 'Affiliation': 'Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bully', 'Initials': 'B', 'LastName': 'Camara', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Guerillot', 'Affiliation': 'Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Donovan', 'Affiliation': 'Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Raquel Sánchez', 'Initials': 'RS', 'LastName': 'Marqués', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.'}, {'ForeName': 'Ousman', 'Initials': 'O', 'LastName': 'Secka', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': ""D'Alessandro"", 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bottomley', 'Affiliation': 'Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Howden', 'Affiliation': 'Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Roca', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa609']
3367,31344740,[French comment on article Cuff-assisted versus cap-assisted colonoscopy for adenoma detection: results of a randomized study].,,2019,,['adenoma detection'],['Cuff-assisted versus cap-assisted colonoscopy'],[],"[{'cui': 'C0001430', 'cui_str': 'Adenoma'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",[],,0.0257066,,[],Endoscopy,['10.1055/a-0965-1358']
3368,22534451,Mindfulness-based relapse prevention for substance craving.,"Craving, defined as the subjective experience of an urge or desire to use substances, has been identified in clinical, laboratory, and preclinical studies as a significant predictor of substance use, substance use disorder, and relapse following treatment for a substance use disorder. Various models of craving have been proposed from biological, cognitive, and/or affective perspectives, and, collectively, these models of craving have informed the research and treatment of addictive behaviors. In this article we discuss craving from a mindfulness perspective, and specifically how mindfulness-based relapse prevention (MBRP) may be effective in reducing substance craving. We present secondary analyses of data from a randomized controlled trial that examined MBRP as an aftercare treatment for substance use disorders. In the primary analyses of the data from this trial, Bowen and colleagues (2009) found that individuals who received MBRP reported significantly lower levels of craving following treatment, in comparison to a treatment-as-usual control group, which mediated subsequent substance use outcomes. In the current study, we extend these findings to examine potential mechanisms by which MBRP might be associated with lower levels of craving. Results indicated that a latent factor representing scores on measures of acceptance, awareness, and nonjudgment significantly mediated the relation between receiving MBRP and self-reported levels of craving immediately following treatment. The mediation findings are consistent with the goals of MBRP and highlight the importance of interventions that increase acceptance and awareness, and help clients foster a nonjudgmental attitude toward their experience. Attending to these processes may target both the experience of and response to craving.",2013,"The mediation findings are consistent with the goals of MBRP and highlight the importance of interventions that increase acceptance and awareness, and help clients foster a nonjudgmental attitude toward their experience.",[],['MBRP'],['levels of craving'],[],[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",,0.0243303,"The mediation findings are consistent with the goals of MBRP and highlight the importance of interventions that increase acceptance and awareness, and help clients foster a nonjudgmental attitude toward their experience.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, Washington State University-Vancouver, USA. Electronic address: katie.witkiewitz@wsu.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'Center for the Study of Health and Risk Behaviors, Department of Psychiatry, University of Washington, Box\xa0354944, 1100 NE 45th St, Suite 300, Seattle, WA 98105, USA. Electronic address: swbowen@uw.edu.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Douglas', 'Affiliation': 'Department of Psychology, University of Washington, Box\xa0351525, Seattle, WA 98195, USA. Electronic address: hacdougl@uw.edu.'}, {'ForeName': 'Sharon H', 'Initials': 'SH', 'LastName': 'Hsu', 'Affiliation': 'Department of Psychology, University of Washington, Box\xa0351525, Seattle, WA 98195, USA. Electronic address: shsinhsu@gmail.com.'}]",Addictive behaviors,['10.1016/j.addbeh.2012.04.001']
3369,30922885,Delphi procedure in core outcome set development: rating scale and consensus criteria determined outcome selection.,"OBJECTIVE


The objective of this study was to compare two different rating scales within one Delphi study for defining consensus in core outcome set development and to explore the influence of consensus criteria on the outcome selection.
STUDY DESIGN AND SETTING


Randomized controlled parallel group trial with 1:1 allocation within the first Delphi round of the Core Outcome Set in the Incontinence-Associated Dermatitis project. Outcomes were rated on a three-point or nine-point Likert scale. Decisions about which outcomes to retain were determined by commonly used consensus criteria (i.e., [combinations of] proportions with restricted ranges, central tendency within a specific range, and decrease in variance).
RESULTS


Fifty-seven participants (group 1 = 28, group 2 = 29) rated 58 outcomes. The use of the nine-point scale resulted in almost twice as many outcomes being rated as ""critical"" compared with the three-point scale (24 vs. 13). Stricter criteria and combining criteria led to less outcomes being identified as ""critical"".
CONCLUSION


The format of rating scales in Delphi studies for core outcome set development and the definition of the consensus criteria influence outcome selection. The use of the nine-point scale might be recommended to inform the consensus process for a subsequent rating or face-to-face meeting. The three-point scale might be preferred when determining final consensus.",2019,"The use of the nine-point scale resulted in almost twice as many outcomes being rated as ""critical"" compared with the three-point scale (24 vs. 13).",['Fifty-seven participants (group 1\xa0'],[],[],"[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]",[],[],,0.0579712,"The use of the nine-point scale resulted in almost twice as many outcomes being rated as ""critical"" compared with the three-point scale (24 vs. 13).","[{'ForeName': 'Dorien', 'Initials': 'D', 'LastName': 'De Meyer', 'Affiliation': 'Department of Public Health and Primary Care, Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kottner', 'Affiliation': 'Department of Public Health and Primary Care, Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium; Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité-Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Beele', 'Affiliation': 'Department of Dermatology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schmitt', 'Affiliation': 'Center for Evidence-Based Healthcare, Medizinische Fakultät Carl Gustav Carus TU Dresden, Dresden, Germany.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Center for Evidence-Based Healthcare, Medizinische Fakultät Carl Gustav Carus TU Dresden, Dresden, Germany.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Van Hecke', 'Affiliation': 'Department of Public Health and Primary Care, Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium; Nursing Department, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Verhaeghe', 'Affiliation': 'Department of Public Health and Primary Care, Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium; Department Health Care, VIVES University College, Roeselare, Belgium.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Beeckman', 'Affiliation': 'Department of Public Health and Primary Care, Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium; Faculty of Medicine & Health Sciences, School of Nursing and Midwifery, Royal College of Surgeons in Ireland (RCSI), Dublin, Ireland; School of Health Sciences, Örebro University, Örebro, Sweden. Electronic address: Dimitri.Beeckman@UGent.be.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.03.011']
3370,31214935,Application of System Dynamics to Inform a Model of Adolescent SBIRT Implementation in Primary Care Settings.,"System dynamics (SD) modeling is used to compare and contrast strategies for effective implementation of an evidence-based adolescent behavioral health treatment in primary care settings. With qualitative and quantitative data from an on-going cluster-randomized trial in 7 federally qualified health center sites, two implementation conditions were compared: generalist vs. specialist. In the generalist approach, the primary care provider (PCP) delivered brief intervention (BI) for substance misuse (n = 4 clinics). In the specialist approach, BIs were delivered by behavioral health counselors (BHCs) (n = 3 clinics). The resultant SD model compared 'basecase' dynamics to strategic approaches to deploying continuous technical assistance (TA) and performance feedback reporting (PFR). The basecase effectively represented the SBIRT intervention, which reflected actual monthly volume of adolescent primary care visits (N = 9639), screenings (N = 5937), positive screenings (N = 246), and brief interventions (BIs; N = 50) over the 20-month implementation period. Insights gained suggest that implementation outcomes are sensitive to frequency of PFR, with bimonthly events generating the most rapid and sustained screening results. Simulated trends indicated that availability of the BHC directly impacts success of the specialist model. Similarly, understanding PCPs' perception of severity of need for intervention is key to outcomes in either condition.",2020,The resultant SD model compared 'basecase' dynamics to strategic approaches to deploying continuous technical assistance (TA) and performance feedback reporting (PFR).,[],[],[],[],[],[],7.0,0.0147494,The resultant SD model compared 'basecase' dynamics to strategic approaches to deploying continuous technical assistance (TA) and performance feedback reporting (PFR).,"[{'ForeName': 'David William', 'Initials': 'DW', 'LastName': 'Lounsbury', 'Affiliation': 'Montefiore Medical Center, Division of Community Collaboration and Implementation Science, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Bronx, NY, 10461, USA. David.Lounsbury@einstein.yu.edu.'}, {'ForeName': 'Shannon Gwin', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Kristi Ann', 'Initials': 'KA', 'LastName': 'Dusek', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Josh Zhi', 'Initials': 'JZ', 'LastName': 'Li', 'Affiliation': 'College of Global Public Health, New York University, New York, NY, USA.'}, {'ForeName': 'Arethusa S', 'Initials': 'AS', 'LastName': 'Kirk', 'Affiliation': 'Total Health Care, Baltimore, MD, USA.'}, {'ForeName': 'Marla', 'Initials': 'M', 'LastName': 'Oros', 'Affiliation': 'The Mosaic Group, Baltimore, MD, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Hosler', 'Affiliation': 'University of Maryland Baltimore County, Baltimore, MD, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gryczynski', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Monico', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Brown', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}]",The journal of behavioral health services & research,['10.1007/s11414-019-09650-y']
3371,31425397,Implementing Data to Care-What Are the Costs for the Health Department?,"BACKGROUND


The Cooperative Re-Engagement Controlled Trial (CoRECT) is a randomized controlled trial that uses a combined health department-provider data to care (D2C) model to identify out-of-care HIV-infected persons. We present cost data for programmatic aspects of the trial during the start-up period (first 30 days of the study).
METHODS


We used microcosting methods to estimate health department start-up costs. We collected start-up cost data between September 2016 and December 2016; 3 health departments completed a form to capture expenses for the initial 30 days of study implementation; the start date varied by health department. All costs are expressed in 2016 US dollars.
RESULTS


Among the 3 health departments, the total start-up costs ranged from $14,145 to $26,058. Total start-up labor hours ranged from 224 to 640 hours.
CONCLUSIONS


As D2C expands nationally with cooperative agreement, PS 18-1802 health departments may be able to use a similar analysis to consider the labor, time, and resources needed to implement D2C within their jurisdiction.",2019,"Among the 3 health departments, the total start-up costs ranged from $14,145 to $26,058.",[],[],['total start-up costs'],[],[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0477273,"Among the 3 health departments, the total start-up costs ranged from $14,145 to $26,058.","[{'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Neblett Fanfair', 'Affiliation': 'Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Ram K', 'Initials': 'RK', 'LastName': 'Shrestha', 'Affiliation': 'Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Randall', 'Affiliation': 'Massachusetts Department of Public Health, Boston, MA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Lucas', 'Affiliation': 'Philadelphia Department of Public Health, Philadelphia, PA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Nichols', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Nasima M', 'Initials': 'NM', 'LastName': 'Camp', 'Affiliation': 'Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Brady', 'Affiliation': 'Philadelphia Department of Public Health, Philadelphia, PA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Jenkins', 'Affiliation': 'Connecticut Department of Public Health, Hartford, CT.'}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Altice', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Merceditas', 'Initials': 'M', 'LastName': 'Villanueva', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'DeMaria', 'Affiliation': 'Massachusetts Department of Public Health, Boston, MA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000001968']
3372,31115361,"Commentary on ""simplifying the ShangRing technique for circumcision in boys and men: use of the no-flip technique with randomization to removal at 7 days versus spontaneous detachment"".",,2019,,['boys and men'],[],[],"[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],[],,0.020673,,"[{'ForeName': 'Yi-Fei', 'Initials': 'YF', 'LastName': 'Wang', 'Affiliation': '.'}]",Asian journal of andrology,['10.4103/aja.aja_32_19']
3373,31184694,Corrigendum. Mifepristone treatment prior to insertion of a levonorgestrel releasing intrauterine system for improved bleeding control - a randomized controlled trial.,,2019,,[],"['Mifepristone', 'levonorgestrel releasing intrauterine system']",[],[],"[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C1708694', 'cui_str': 'Levonorgestrel-releasing intrauterine system'}]",[],,0.160563,,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Papaikonomou', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University, Stockholm, Sweden.""}, {'ForeName': 'Helena Kopp', 'Initials': 'HK', 'LastName': 'Kallner', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University, Stockholm, Sweden.""}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Söderdahl', 'Affiliation': 'Statisticon AB, Uppsala, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University, Stockholm, Sweden.""}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez092']
3374,31335603,CORR Insights®: Perineal Pressure During Hip Arthroscopy Is Reduced by Use of Trendelenburg: A Prospective Study With Randomized Order of Positioning.,,2019,,[],"['Trendelenburg', 'CORR Insights®: Perineal Pressure', 'Hip Arthroscopy']",[],[],"[{'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}]",[],,0.0267359,,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Leunig', 'Affiliation': 'M. Leunig, Schulthess Clinic, Department of Orthopaedic Surgery, Zürich, Switzerland.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000879']
3375,30988478,A values-alignment intervention protects adolescents from the effects of food marketing.,"Adolescents are exposed to extensive marketing for junk food, which drives overconsumption by creating positive emotional associations with junk food 1-6 . Here we counter this influence with an intervention that frames manipulative food marketing as incompatible with important adolescent values, including social justice and autonomy from adult control. In a preregistered, longitudinal, randomized, controlled field experiment, we show that this framing intervention reduces boys' and girls' implicit positive associations with junk food marketing and substantially improves boys' daily dietary choices in the school cafeteria. Both of these effects were sustained for at least three months. These findings suggest that reframing unhealthy dietary choices as incompatible with important values could be a low-cost, scalable solution to producing lasting, internalized change in adolescents' dietary attitudes and choices.",2019,Both of these effects were sustained for at least three months.,[],[],[],[],[],[],,0.0598307,Both of these effects were sustained for at least three months.,"[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'University of Chicago Booth School of Business, Chicago, IL, USA. christopher.bryan@chicagobooth.edu.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Yeager', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Cintia P', 'Initials': 'CP', 'LastName': 'Hinojosa', 'Affiliation': 'University of Chicago Booth School of Business, Chicago, IL, USA.'}]",Nature human behaviour,['10.1038/s41562-019-0586-6']
3376,30922106,Effectiveness of psychological intervention as add-on to standard cardiac rehabilitation: Time to adopt new methods or keep doing more of the same?,,2019,,[],['psychological intervention'],[],[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]",[],,0.017222,,"[{'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Pedersen', 'Affiliation': '1 Department of Psychology, University of Southern Denmark, Denmark.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Doyle', 'Affiliation': '3 Department of Health Psychology, Royal College of Surgeons in Ireland, Ireland.'}]",European journal of preventive cardiology,['10.1177/2047487319840176']
3377,27910283,Feeding behaviors during home-based treatment of moderate acute malnutrition using corn-soy blends or lipid-based nutrient supplements.,"Feeding behaviors have an important impact on children's nutritional status and are essential to consider when implementing nutrition programs. The objective of this study was to explore and compare feeding behaviors related to supplementary feeding with corn-soy blends (CSB) and lipid-based nutrient supplements (LNS) based on best practice feeding behaviors. The study was conducted as part of a randomized controlled trial assessing the effectiveness of new formulations of CSB and LNS and comprised 1,546 children from 6 to 23 months. The study included a mixed methods approach using questionnaires, focus group discussions and home visits and interviews with a subsample of 20 caretakers of trial participants. We found that LNS, compared to CSB, were more likely to be mixed into other foods (OR [95% CI] 1.7 [1.3-2.2], p = <.001), served with a meal (OR [95% CI] 1.6 [1.1-2.3], p = <.018)or between meals (OR [95% CI] 1.5 [1.1-1.9], p = <.005), and fed using an encouraging feeding style (mean difference in percentage points [95% CI] 23% [6%:40%], p = .01). CSB were more likely to be fed using a forced feeding style (mean difference in percentage points [95% CI] 18% [3%:33%], p = .02) and were often observed to be served unprepared. The main differences in feeding behaviors between the two diet groups were linked to how and when supplements were served. Educational instructions should therefore be adapted according to the supplement provided; when providing CSB, efforts should be made to promote an encouraging feeding style, and emphasis should be made to ensure preparations are made according to recommendations.",2017,"The study was conducted as part of a randomized controlled trial assessing the effectiveness of new formulations of CSB and LNS and comprised 1,546 children from 6 to 23 months.","['1,546 children from 6 to 23\xa0months']","['LNS', 'CSB and LNS', 'corn-soy blends or lipid-based nutrient supplements', 'supplementary feeding with corn-soy blends (CSB) and lipid-based nutrient supplements (LNS']","['feeding behaviors', 'CSB']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",1546.0,0.0579856,"The study was conducted as part of a randomized controlled trial assessing the effectiveness of new formulations of CSB and LNS and comprised 1,546 children from 6 to 23 months.","[{'ForeName': 'Ann-Sophie', 'Initials': 'AS', 'LastName': 'Iuel-Brockdorf', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen and Médecins Sans Frontières, Copenhagen, Denmark.'}, {'ForeName': 'Albertine', 'Initials': 'A', 'LastName': 'Ouedraogo', 'Affiliation': 'The Alliance for International Medical Action, Paris, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tania Aase', 'Initials': 'TA', 'LastName': 'Draebel', 'Affiliation': 'Department of International Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'School of Medicine, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Filteau', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Kim F', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}]",Maternal & child nutrition,['10.1111/mcn.12399']
3378,31388905,"Capsule Commentary on Satre et al., ""Interventions to Reduce Unhealthy Alcohol Use among Primary Care Patients with HIV: the Health and Motivation Randomized Clinical Trial"".",,2019,,['Primary Care Patients with HIV'],['Interventions'],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",[],[],,0.0480839,,"[{'ForeName': 'Lori D', 'Initials': 'LD', 'LastName': 'Karan', 'Affiliation': 'Internal Medicine and Preventive Medicine, Loma Linda University Medical School, Loma Linda, USA. lori.karan@gmail.com.'}]",Journal of general internal medicine,['10.1007/s11606-019-05171-8']
3379,31329518,Questions Regarding the Randomized Phase II Trial of Defactinib as Maintenance Therapy in Malignant Pleural Mesothelioma.,,2019,,['Malignant Pleural Mesothelioma'],['Defactinib'],[],"[{'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura (disorder)'}]","[{'cui': 'C3899400', 'cui_str': 'defactinib'}]",[],,0.0167705,,"[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Masuda', 'Affiliation': 'Ken Masuda, MD and Hiroto Ishiki, MD, National Cancer Center Hospital, Tokyo, Japan; Shunsuke Oyamada, MS, JORTC Data Center, Tokyo, Japan; and Masaki Shimizu, MD; Daisuke Kiuchi, MD; and Eriko Satomi, MD, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Ishiki', 'Affiliation': 'Ken Masuda, MD and Hiroto Ishiki, MD, National Cancer Center Hospital, Tokyo, Japan; Shunsuke Oyamada, MS, JORTC Data Center, Tokyo, Japan; and Masaki Shimizu, MD; Daisuke Kiuchi, MD; and Eriko Satomi, MD, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Oyamada', 'Affiliation': 'Ken Masuda, MD and Hiroto Ishiki, MD, National Cancer Center Hospital, Tokyo, Japan; Shunsuke Oyamada, MS, JORTC Data Center, Tokyo, Japan; and Masaki Shimizu, MD; Daisuke Kiuchi, MD; and Eriko Satomi, MD, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Shimizu', 'Affiliation': 'Ken Masuda, MD and Hiroto Ishiki, MD, National Cancer Center Hospital, Tokyo, Japan; Shunsuke Oyamada, MS, JORTC Data Center, Tokyo, Japan; and Masaki Shimizu, MD; Daisuke Kiuchi, MD; and Eriko Satomi, MD, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kiuchi', 'Affiliation': 'Ken Masuda, MD and Hiroto Ishiki, MD, National Cancer Center Hospital, Tokyo, Japan; Shunsuke Oyamada, MS, JORTC Data Center, Tokyo, Japan; and Masaki Shimizu, MD; Daisuke Kiuchi, MD; and Eriko Satomi, MD, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Satomi', 'Affiliation': 'Ken Masuda, MD and Hiroto Ishiki, MD, National Cancer Center Hospital, Tokyo, Japan; Shunsuke Oyamada, MS, JORTC Data Center, Tokyo, Japan; and Masaki Shimizu, MD; Daisuke Kiuchi, MD; and Eriko Satomi, MD, National Cancer Center Hospital, Tokyo, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00891']
3380,31931509,The acute effects of nicotine on corticostriatal responses to distinct phases of reward processing.,"Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues. This anticipatory effect is selective as no clear evidence has emerged showing that nicotine acutely changes reward receipt reactivity. However, repeated rewarding experiences shift peak brain reactivity from hedonic reward outcome to the motivational anticipatory cue yielding more habitual cue-induced behavior. Given nicotine's influence on NAcc reactivity and connectivity, it is plausible that nicotine acutely induces this shift and alters NAcc functional connectivity during reward processing. To evaluate this currently untested hypothesis, a randomized crossover design was used in which healthy non-smokers were administered placebo and nicotine (2-mg lozenge). Brain activation to monetary reward anticipation and outcome was evaluated with functional magnetic resonance imaging. Relative to placebo, nicotine induced more NAcc reactivity to reward anticipation. Greater NAcc activation during anticipation was significantly associated with lower NAcc activation to outcome. During outcome, nicotine reduced NAcc functional connectivity with cortical regions including the anterior cingulate cortex, orbitofrontal cortex, and insula. These regions showed the same negative relationship between reward anticipation and outcome as noted in the NAcc. The current findings significantly improve our understanding of how nicotine changes corticostriatal circuit function and communication during distinct phases of reward processing and critically show that these alterations happen acutely following a single dose. The implications of this work explain nicotinic modulation of general reward function, which offer insights into the initial drive to smoke and the subsequent difficulty in cessation.",2020,Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues.,['healthy non-smokers'],"['nicotine', 'Nicotine', 'placebo and nicotine (2-mg lozenge', 'placebo, nicotine']","['anterior cingulate cortex, orbitofrontal cortex, and insula', 'Greater NAcc activation', 'habitual cue-induced behavior']","[{'cui': 'C4554605', 'cui_str': 'Nonsmokers'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0321595,Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues.,"[{'ForeName': 'Kainan S', 'Initials': 'KS', 'LastName': 'Wang', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Zegel', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Molokotos', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Lauren V', 'Initials': 'LV', 'LastName': 'Moran', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Olson', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Janes', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA. ajanes@mclean.harvard.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0611-5']
3381,31362999,Lactobacillus bulgaricus  improves antioxidant capacity of black garlic in the prevention of gestational diabetes mellitus: a randomized control trial.,"Objectives:   Lactobacillus bulgaricus  may improve antioxidant capacity of black garlic in the prevention of gestational diabetes mellitus (GDM). Methods:  Black garlic was prepared with or without  L. bulgaricus  Volatile and polysaccharides were analyzed by using LC-MS, Fourier Transform infrared (FTIR) and  13 C nuclear magnetic resonance (NMR). The study design was parallel randomized controlled trial and 226 GDM patients were randomly assigned into BG (black garlic and  L. bulgaricus ) and CG (black garlic) groups, and allocation ratio was 1:1. The treatment duration was 40 weeks. Fasting blood glucose (FBG) and 1- and 2-h blood glucose (1hBG and 2hBG) after oral glucose tolerance test (OGTT) were detected. Antioxidant function of black garlic was determined by measuring plasma malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-PX) and total antioxidant capacity (T-AOC) in GDM patients. The comparison between two groups was made using two independent samples  t  test. Results:  The intake of nutrients was similar between two groups ( P >0.05).  L. bulgaricus  promoted the transformation of the glucopyranoside to glucofuranoside.  L. bulgaricus  increased the abilities of black garlic for scavenging hydroxyl radicals, 2,2'-azino-bis (3-ethylbenzenthiazoline-6-sulfonic) acid (ABTS) and DPPH free radicals.  L. bulgaricus  reduced the levels of FBG, 1hBG and 2hBG, and incidence of perinatal complications ( P <0.01). Plasma MDA level in the BG group was lower than in the CG group, whereas the levels of SOD, GSH-PX and T-AOC in the BG group were higher than in the CG group ( P <0.01). Conclusions:   L. bulgaricus  improves antioxidant capacity of black garlic in the prevention of GDM.",2019,"Plasma MDA level in the BG group was lower than in the CG group, whereas the levels of SOD, GSH-PX and T-AOC in the BG group were higher than in the CG group ( P <0.01).","['226 GDM patients', 'gestational diabetes mellitus', 'GDM patients', 'gestational diabetes mellitus (GDM']","['Black garlic', 'BG (black garlic and  L. bulgaricus ) and CG (black garlic']","['levels of FBG, 1hBG and 2hBG, and incidence of perinatal complications', 'antioxidant capacity', 'Antioxidant function of black garlic', 'levels of SOD, GSH-PX and T-AOC', 'Fasting blood glucose (FBG) and 1- and 2-h blood glucose (1hBG and 2hBG) after oral glucose tolerance test (OGTT', "" 2,2'-azino-bis (3-ethylbenzenthiazoline-6-sulfonic) acid (ABTS) and DPPH free radicals"", 'plasma malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-PX) and total antioxidant capacity (T-AOC', 'Plasma MDA level', 'scavenging hydroxyl radicals', 'intake of nutrients']","[{'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0016693', 'cui_str': 'Free Radicals'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0063146', 'cui_str': 'Hydroxyl'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]",,0.0441565,"Plasma MDA level in the BG group was lower than in the CG group, whereas the levels of SOD, GSH-PX and T-AOC in the BG group were higher than in the CG group ( P <0.01).","[{'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Si', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130000, China.'}, {'ForeName': 'Ruixin', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Department of Genral Surgery, The Second Hospital of Jilin University, Changchun 130000, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130000, China.'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Jian', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130000, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130000, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130000, China.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130000, China yangshulimd@163.com.'}]",Bioscience reports,['10.1042/BSR20182254']
3382,30655627,"Gender difference in the effects of cacao polyphenols on blood pressure and glucose/lipid metabolism in prediabetic subjects: a double-blinded, randomized, placebo-controlled crossover trial.",,2019,,['prediabetic subjects'],"['cacao polyphenols', 'placebo']",['blood pressure and glucose/lipid metabolism'],[],"[{'cui': 'C0006622', 'cui_str': 'Cocoa Plant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",,0.615842,,"[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Shiina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan. tomiyama@tokyo-med.ac.jp.'}, {'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Syunsuke', 'Initials': 'S', 'LastName': 'Komatsu', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Natsume', 'Affiliation': 'R&D Division, Meiji Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Chisato', 'Initials': 'C', 'LastName': 'Oba', 'Affiliation': 'R&D Division, Meiji Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Ohshiba', 'Affiliation': 'R&D Division, Meiji Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Taketo', 'Initials': 'T', 'LastName': 'Yamaji', 'Affiliation': 'R&D Division, Meiji Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Taishiro', 'Initials': 'T', 'LastName': 'Chikamori', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yamashina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0208-8']
3383,31463764,Reply to correspondence letter: Oral vitamin A supplementation in very low birth weight neonates: a randomized controlled trial.,,2019,,['very low birth weight neonates'],"['correspondence letter', 'Oral vitamin A supplementation']",[],"[{'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}]",[],,0.223567,,"[{'ForeName': 'Sriparna', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India. drsriparnabasu@rediffmail.com.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Khanna', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'Ragini', 'Initials': 'R', 'LastName': 'Srivastava', 'Affiliation': 'Department of Biochemistry, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}]",European journal of pediatrics,['10.1007/s00431-019-03454-0']
3384,31537281,Bicuspid Aortic Valve Stenosis: Is it Too Early for a Randomized Trial?,,2019,,['Bicuspid Aortic Valve Stenosis'],[],[],"[{'cui': 'C0149630', 'cui_str': 'Bicuspid aortic valve (disorder)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}]",[],[],,0.0251374,,"[{'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchetche', 'Affiliation': 'Groupe CardioVasculaire Interventionnel, Clinique PASTEUR, Toulouse, France. Electronic address: d.tchetche@clinique-pasteur.com.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.07.007']
3385,31743424,Estimating individualized treatment regimes from crossover designs.,"The field of precision medicine aims to tailor treatment based on patient-specific factors in a reproducible way. To this end, estimating an optimal individualized treatment regime (ITR) that recommends treatment decisions based on patient characteristics to maximize the mean of a prespecified outcome is of particular interest. Several methods have been proposed for estimating an optimal ITR from clinical trial data in the parallel group setting where each subject is randomized to a single intervention. However, little work has been done in the area of estimating the optimal ITR from crossover study designs. Such designs naturally lend themselves to precision medicine since they allow for observing the response to multiple treatments for each patient. In this paper, we introduce a method for estimating the optimal ITR using data from a 2 × 2 crossover study with or without carryover effects. The proposed method is similar to policy search methods such as outcome weighted learning; however, we take advantage of the crossover design by using the difference in responses under each treatment as the observed reward. We establish Fisher and global consistency, present numerical experiments, and analyze data from a feeding trial to demonstrate the improved performance of the proposed method compared to standard methods for a parallel study design.",2019,"We establish Fisher and global consistency, present numerical experiments, and analyze data from a feeding trial to demonstrate the improved performance of the proposed method compared to standard methods for a parallel study design.",[],[],[],[],[],[],,0.0469592,"We establish Fisher and global consistency, present numerical experiments, and analyze data from a feeding trial to demonstrate the improved performance of the proposed method compared to standard methods for a parallel study design.","[{'ForeName': 'Crystal T', 'Initials': 'CT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Luckett', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Kahkoska', 'Affiliation': 'Department of Nutrition, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Shearrer', 'Affiliation': 'Department of Nutrition, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spruijt-Metz', 'Affiliation': 'Center of Economic and Social Research, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Jaimie N', 'Initials': 'JN', 'LastName': 'Davis', 'Affiliation': 'Department of Nutrition, University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Kosorok', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina.'}]",Biometrics,['10.1111/biom.13186']
3386,31700423,Prevention of COPD exacerbations by salmeterol/fluticasone propionate or tiotropium - the INSPIRE study.,,2008,,[],['salmeterol/fluticasone propionate or tiotropium'],['COPD exacerbations'],[],"[{'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]","[{'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}]",,0.194844,,"[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Chair, Family Physician Airways Group of Canada.'}]",Primary care respiratory journal : journal of the General Practice Airways Group,['10.3132/pcrj.2008.00022']
3387,30674702,Mobile self-compassion programme for promotion of public mental health: a randomised controlled trial.,,2019,,['public mental health'],['Mobile self-compassion programme'],[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",[],,0.234923,,"[{'ForeName': 'W W S', 'Initials': 'WWS', 'LastName': 'Mak', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong.'}, {'ForeName': 'C C Y', 'Initials': 'CCY', 'LastName': 'Wong', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong.'}, {'ForeName': 'A T Y', 'Initials': 'ATY', 'LastName': 'Chan', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong.'}, {'ForeName': 'J T F', 'Initials': 'JTF', 'LastName': 'Lau', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[]
3388,31652075,Effects of Feedback on Midwifery Students' Self-Assessed Performance and Their Self-Assessment Ability: A Quasi-Experimental Study.,"This study aimed to evaluate the effects of verbal and written feedback in clinical midwifery placement on students' self-assessed performance and their self-assessment ability. This three-group quasi-experimental study was conducted on 120 students. Participants in the control group received clinical education through the routine method, while in the feedback groups received either verbal or written feedback methods on the basis of the sandwich feedback model. In the last day of clinical education, a checklist was simultaneously filled out by participants and a second instructor. There was significant direct correlation between the scores of performance assessment by both the second instructor and students in the control group ( r  = .38,  p  = .01), the verbal feedback group ( r  = .63,  p  < .001), and the written feedback group ( r  = .74,  p  < .001). The rates of student-instructor agreement in the control, verbal feedback, and written feedback groups were 32.5%, 70%, and 77.5%, respectively. Feedback is effective in significantly improving students' self-assessment ability.",2020,,[],[],"[""Midwifery Students' Self-Assessed Performance and Their Self-Assessment Ability""]",[],[],"[{'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0119658,,"[{'ForeName': 'Mehrnaz', 'Initials': 'M', 'LastName': 'Geranmayeh', 'Affiliation': 'Department of Reproductive Health and Midwifery, School of Nursing and Midwifery, Tehran University of Medical Sciences, Iran.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Khakbazan', 'Affiliation': 'Department of Reproductive Health and Midwifery, School of Nursing and Midwifery, Tehran University of Medical Sciences, Iran.'}, {'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Azizi', 'Affiliation': 'School of Nursing and Midwifery, Astara Azad University, Gilan, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Mehran', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Tehran University of Medical Sciences, Iran.'}]",International quarterly of community health education,['10.1177/0272684X19885512']
3389,31737988,Gradually closing the loop.,"The Lariat device is an epicardial nonimplant suture delivery device capable of left atrial appendage closure. The current study offers promising results but is limited by small sample size and multiple foundational issues with study design. aMaze, a large multi-center prospective randomized trial is currently underway and will provide additional insight into the safety of this device and its efficacy in maintenance of sinus rhythm after atrial fibrillation ablation.",2019,The Lariat device is an epicardial nonimplant suture delivery device capable of left atrial appendage closure.,[],['aMaze'],[],[],"[{'cui': 'C0102901', 'cui_str': 'Amaze'}]",[],,0.0568751,The Lariat device is an epicardial nonimplant suture delivery device capable of left atrial appendage closure.,"[{'ForeName': 'Elliot S', 'Initials': 'ES', 'LastName': 'Jerud', 'Affiliation': 'Department of Cardiology, Lankenau Heart Institute, Wynnewood, Pennsylvania.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Gray', 'Affiliation': 'Interventional Cardiology, Lankenau Heart Institute, Wynnewood, Pennsylvania.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28570']
3390,31419294,"Dose-Dependent Infectivity of Aseptic, Purified, Cryopreserved Plasmodium falciparum 7G8 Sporozoites in Malaria-Naive Adults.","Direct venous inoculation of 3.2 × 103 aseptic, purified, cryopreserved, vialed Plasmodium falciparum (Pf) strain NF54 sporozoites, PfSPZ Challenge (NF54), has been used for controlled human malaria infection (CHMI) in the United States, 4 European countries, and 6 African countries. In nonimmune adults, this results in 100% infection rates. We conducted a double-blind, randomized, dose-escalation study to assess the infectivity of the 7G8 clone of Pf (PfSPZ Challenge [7G8]). Results showed dose-dependent infectivity from 43% for 8 × 102 PfSPZ to 100% for 4.8 × 103 PfSPZ. PfSPZ Challenge (7G8) will allow for more complete assessment by CHMI of antimalarial vaccines and drugs.",2019,Results showed dose-dependent infectivity from 43% for 8x102 PfSPZ to 100% for 4.8x103 PfSPZ.,['malaria-naive adults'],"['7G8 clone of Pf (PfSPZ Challenge [7G8', 'PfSPZ Challenge (7G8']",[],"[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009013', 'cui_str': 'Clones'}]",[],,0.0885804,Results showed dose-dependent infectivity from 43% for 8x102 PfSPZ to 100% for 4.8x103 PfSPZ.,"[{'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Laurens', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Berry', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Travassos', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Strauss', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Adams', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Biraj', 'Initials': 'B', 'LastName': 'Shrestha', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Eappen', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Manoj', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Yonas', 'Initials': 'Y', 'LastName': 'Abebe', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Tooba', 'Initials': 'T', 'LastName': 'Murshedkar', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Gunasekera', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Richie', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Christopher V', 'Initials': 'CV', 'LastName': 'Plowe', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Jessie K', 'Initials': 'JK', 'LastName': 'Kennedy', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Gail E', 'Initials': 'GE', 'LastName': 'Potter', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Deye', 'Affiliation': 'Parasitology and International Programs Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'B K L', 'Initials': 'BKL', 'LastName': 'Sim', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz410']
3391,31463765,Re: Oral vitamin A supplementation in very low birth weight neonates: a randomized controlled trial.,,2019,,['very low birth weight neonates'],['vitamin A supplementation'],[],"[{'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}]",[],,0.314717,,"[{'ForeName': 'Dnyanada', 'Initials': 'D', 'LastName': 'Mhatre', 'Affiliation': 'Surya Hospital, S V Road, Santacruz West, Mumbai, Maharashtra, 400054, India.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Agrawal', 'Affiliation': 'Surya Hospital, S V Road, Santacruz West, Mumbai, Maharashtra, 400054, India.'}, {'ForeName': 'Haribalakrishna', 'Initials': 'H', 'LastName': 'Balasubramanian', 'Affiliation': 'Surya Hospital, S V Road, Santacruz West, Mumbai, Maharashtra, 400054, India. doctorhbk@gmail.com.'}, {'ForeName': 'Nandkishor', 'Initials': 'N', 'LastName': 'Kabra', 'Affiliation': 'Surya Hospital, S V Road, Santacruz West, Mumbai, Maharashtra, 400054, India.'}]",European journal of pediatrics,['10.1007/s00431-019-03449-x']
3392,31740427,An efficient Bayesian platform trial design for borrowing adaptively from historical control data in lymphoma.,"To reduce a clinical trial's cost and ethical risk to its enrollees, some oncology trial designers have suggested borrowing information from similar but already completed trials to reduce the number of patients needed for the current study. Motivated by competing drug therapies for lymphoma, we propose a Bayesian adaptive ""platform"" trial design that uses commensurate prior methods at interim analyses to borrow adaptively from the control group of an earlier-starting trial. The design adjusts the trial's randomization ratio in favor of the novel treatment when the interim posterior indicates commensurability of the two control groups. In this setting, our design can supplement a control arm with historical data, and randomize more new patients to the novel treatments. This design is both ethical and economical, since it shortens the process of introducing new treatments into the market, and any additional costs introduced by this design will be compensated by the savings in control arm sizes. Our approach performs well via simulation across settings with varying degrees of commensurability and true treatment effects, and compares favorably to an adaptive ""all-or-nothing"" approach in which the decision to pool or discard historical controls is based on a simple ad-hoc frequentist test at interim analysis. We also consider a three drug extension where a new imaginary intervention joins the platform, and show again that our procedure performs well via simulation.",2020,"Our approach performs well via simulation across settings with varying degrees of commensurability and true treatment effects, and compares favorably to an adaptive ""all-or-nothing"" approach in which the decision to pool or discard historical controls is based on a simple ad-hoc frequentist test at interim analysis.",['lymphoma'],[],[],"[{'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}]",[],[],,0.0738965,"Our approach performs well via simulation across settings with varying degrees of commensurability and true treatment effects, and compares favorably to an adaptive ""all-or-nothing"" approach in which the decision to pool or discard historical controls is based on a simple ad-hoc frequentist test at interim analysis.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Normington', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, USA. Electronic address: jpnormington@gmail.com.'}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Genentech, Dept. of Biostatistics, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Mattiello', 'Affiliation': 'F. Hoffmann-La Roche, Dept. of Biostatistics, Grenzacherstrasse 124, 4070 Basel, Switzerland.'}, {'ForeName': 'Somnath', 'Initials': 'S', 'LastName': 'Sarkar', 'Affiliation': 'Flatiron Health, New York, NY, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Carlin', 'Affiliation': 'Counterpoint Statistical Consulting, Minneapolis, MN, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105890']
3393,31816478,Differential antiseizure medication sensitivity of the Affective Reactivity Index: A randomized controlled trial in new-onset pediatric focal epilepsy.,"BACKGROUND


Irritability is a adverse effect of many antiseizure medications (ASMs), but there are no validated measures currently available to characterize this behavioral risk. We examined both child and parent/guardian versions of the Affective Reactivity Index (ARI), a validated measure developed for application in adolescent psychiatry, to determine its sensitivity to ASM-related irritability. We hypothesized irritability increases associated with levetiracetam (LEV) but not lamotrigine (LTG) or oxcarbazepine (OXC).
METHOD


The ARI was administered to 71 child and parent/guardian pairs randomized to one of three common ASMs (LEV, LTG, OXC) used to treat new-onset focal (localization-related) epilepsy. Subjects were recruited as part of a prospective multicenter, randomized, open-label, parallel group design. The ARI was administered at baseline prior to treatment initiation and again at 3 months after ASM initiation.
RESULTS


There was a significant increase in ARI ratings for both child and parent/guardian ratings for LEV but not LTG or OXC when assessed 3 months after treatment initiation. When examined on the individual subject level using a criterion of at least a 3-point ARI increase, there was an increase associated with LEV for child ratings but not parent/guardian scores.
CONCLUSION


Both child and parent/guardian versions of the ARI appear sensitive to medication-induced irritability associated with LEV on both the group and individual levels. The findings extend the applicability of ARI from characterizing the presence of clinical irritability as a psychiatric diagnostic feature to a more modifiable aspect of behavior change related to medication management and support its use in clinical trial applications.",2020,There was a significant increase in ARI ratings for both child and parent/guardian ratings for LEV but not LTG or OXC when assessed 3 months after treatment initiation.,[],"['lamotrigine (LTG) or oxcarbazepine (OXC', 'levetiracetam (LEV', 'three common ASMs (LEV, LTG, OXC']","['Affective Reactivity Index (ARI', 'ARI ratings', 'Affective Reactivity Index']",[],"[{'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0069751', 'cui_str': 'oxcarbazepine'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C4521846', 'cui_str': 'Vice Admiral'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0220179,There was a significant increase in ARI ratings for both child and parent/guardian ratings for LEV but not LTG or OXC when assessed 3 months after treatment initiation.,"[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Loring', 'Affiliation': 'Departments of Neurology and Pediatrics, Emory University, Atlanta, GA, United States of America. Electronic address: dloring@emory.edu.'}, {'ForeName': 'Kimford J', 'Initials': 'KJ', 'LastName': 'Meador', 'Affiliation': 'Department of Neurology & Neurological Sciences, Stanford University, Palo Alto, CA, United States of America.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Shinnar', 'Affiliation': 'Departments of Neurology, Pediatrics, Epidemiology & Population Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, United States of America.'}, {'ForeName': 'William Davis', 'Initials': 'WD', 'LastName': 'Gaillard', 'Affiliation': ""Department of Neurology, Children's National Health System, Washington, DC, United States of America.""}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Wheless', 'Affiliation': ""Department of Pediatrics, Division of Neurology, University of Tennessee Health Science Center, Le Bonheur Children's Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Sudha K', 'Initials': 'SK', 'LastName': 'Kessler', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, Departments of Neurology and Pediatrics, University of Pennsylvania, Philadelphia, PA, United States of America.""}, {'ForeName': 'Joan A', 'Initials': 'JA', 'LastName': 'Conry', 'Affiliation': ""Department of Neurology, Children's National Health System, Washington, DC, United States of America.""}, {'ForeName': 'Madison M', 'Initials': 'MM', 'LastName': 'Berl', 'Affiliation': ""Department of Neuropsychology, Children's National Health System, Washington, DC, United States of America.""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Burns', 'Affiliation': ""Department of Neuropsychology, Children's Healthcare of Atlanta, Atlanta, GA, United States of America.""}, {'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Glauser', 'Affiliation': ""Division of Neurology, Cincinnati Children's Hospital Medical Center and Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, United States of America.""}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Kinkead', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Emory University, Atlanta, GA, United States of America.'}, {'ForeName': 'Avital', 'Initials': 'A', 'LastName': 'Cnaan', 'Affiliation': 'Department of Pediatrics, George Washington University, Washington, DC, United States of America.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.106687']
3394,31994178,Five-year survival follow-up of a phase III randomised trial comparing ofatumumab versus physicians' choice for bulky fludarabine-refractory chronic lymphocytic leukaemia: a short report.,"In 2014, an interim analysis of a phase 3 study was performed to evaluate the effectiveness of ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukaemia (BFR CLL) as compared to physician's choice. The five-year follow-up of this phase 3 trial showed that ofatumumab therapy resulted in a numerically but not significantly longer overall survival. As only few patients had the chance to receive a kinase inhibitor later, the study displays the survival of BFR CLL patients in the period prior to receiving small-molecule inhibitors. Ofatumumab is a well-tolerable treatment option in multiresistant advanced CLL.",2020,The five-year follow-up of this phase 3 trial showed that ofatumumab therapy resulted in a numerically but not significantly longer overall survival.,"['refractory chronic lymphocytic leukaemia', 'patients with bulky fludarabine-refractory chronic lymphocytic leukaemia (BFR CLL']",['fludarabine'],['overall survival'],"[{'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}]","[{'cui': 'C0059985', 'cui_str': 'fludarabine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0745172,The five-year follow-up of this phase 3 trial showed that ofatumumab therapy resulted in a numerically but not significantly longer overall survival.,"[{'ForeName': 'Udvardy', 'Initials': 'U', 'LastName': 'Miklos', 'Affiliation': 'Department of Hematology, Debrecen University, Debrecen, Hungary.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Strugov', 'Affiliation': 'Almazov National Medical Research Centre, St. Petersburg, Russian Federation.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Lewerin', 'Affiliation': 'Section of Hematology and Coagulation, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Mazur', 'Affiliation': 'Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Steurer', 'Affiliation': 'Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Montillo', 'Affiliation': 'Department of Onco-Hematology, Division of Hematology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Kryachok', 'Affiliation': 'Oncohematology, National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Middeke', 'Affiliation': 'Medizinische Klinik I, Universitaetsklinikum C.G.Carus, Dresden, Germany.'}, {'ForeName': 'Grygoriy', 'Initials': 'G', 'LastName': 'Rekhtman', 'Affiliation': 'Khmelnytskyi Regional Hospital, Khmelnytskyi, Ukraine.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Stefanelli', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Vincent', 'Affiliation': 'Novartis Pharma S.A.S, Paris, France.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Govindaraju', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Österborg', 'Affiliation': 'Department of Hematology, Karolinska University Hospital, Stockholm, Sweden.'}]",British journal of haematology,['10.1111/bjh.16429']
3395,31543515,"Comment on ""Hyaluronic acid injection in glans penis for treatment of premature ejaculation: a randomized controlled cross-over study"".",,2020,,['premature ejaculation'],['Hyaluronic acid injection'],[],"[{'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]",[],,0.0438367,,"[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Gul', 'Affiliation': 'Department of Urology, Aksaray University School of Medicine, Aksaray, Turkey. drmuratgul@hotmail.com.'}]",International journal of impotence research,['10.1038/s41443-019-0200-5']
3396,31698111,Changes in Dosing and Dose Timing of D-Cycloserine Explain Its Apparent Declining Efficacy for Augmenting Exposure Therapy for Anxiety-related Disorders: An Individual Participant-data Meta-analysis.,"The apparent efficacy of d-cycloserine (DCS) for enhancing exposure treatment for anxiety disorders appears to have declined over the past 14 years. We examined whether variations in how DCS has been administered can account for this ""declining effect"". We also investigated the association between DCS administration characteristics and treatment outcome to find optimal dosing parameters. We conducted a secondary analysis of individual participant data obtained from 1047 participants in 21 studies testing the efficacy of DCS-augmented exposure treatments. Different outcome measures in different studies were harmonized to a 0-100 scale. Intent-to-treat analyses showed that, in participants randomized to DCS augmentation (n = 523), fewer DCS doses, later timing of DCS dose, and lower baseline severity appear to account for this decline effect. More DCS doses were related to better outcomes, but this advantage leveled-off at nine doses. Administering DCS more than 60 minutes before exposures was also related to better outcomes. These predictors were not significant in the placebo arm (n = 521). Results suggested that optimal DCS administration could increase pre-to-follow-up DCS effect size by 50%. In conclusion, the apparent declining effectiveness of DCS over time may be accounted for by how it has been administered. Optimal DCS administration may substantially improve outcomes. Registration: The analysis plan for this manuscript was registered on Open Science Framework (https://osf.io/c39p8/).",2019,These predictors were not significant in the placebo arm (n = 521).,"['Anxiety-related Disorders', 'Registration', '1047 participants in 21 studies testing the efficacy of DCS-augmented exposure treatments']","['placebo', 'd-cycloserine (DCS']",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]",[],1047.0,0.10251,These predictors were not significant in the placebo arm (n = 521).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Department of Psychology, Southern Methodist University, Dallas, USA. Electronic address: drosenfi@smu.edu.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Institute for Mental Health Research and Department of Psychology, The University of Texas, Austin, USA.'}, {'ForeName': 'Stefan G', 'Initials': 'SG', 'LastName': 'Hofmann', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mataix-Cols', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Lorena Fernández', 'Initials': 'LF', 'LastName': 'de la Cruz', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rück', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Monzani', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pérez-Vigil', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Frumento', 'Affiliation': 'Unit of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Rianne A', 'Initials': 'RA', 'LastName': 'de Kleine', 'Affiliation': 'Institute of Psychology, Leiden University, The Netherlands.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Difede', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, NY, USA.'}, {'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Farrell', 'Affiliation': 'School of Applied Psychology, Griffith University, Brisbane, Australia; Menzies Health Institute of Queensland, Brisbane, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Geller', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, USA; Harvard Medical School, Boston, USA.'}, {'ForeName': 'Maryrose', 'Initials': 'M', 'LastName': 'Gerardi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Guastella', 'Affiliation': 'Brain and Mind Research Institute, Central Clinical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Hendriks', 'Affiliation': 'Behavioral Science Institute, Radboud University Nijmegen, The Netherlands; Overwaal Center of Expertise for Anxiety Disorders OCD and PTSD, Institution for Integrated Mental Health Care Pro Persona, Nijmegen, the Netherlands.'}, {'ForeName': 'Matt G', 'Initials': 'MG', 'LastName': 'Kushner', 'Affiliation': 'Department of Psychiatry, University of Minnesota-Twin Cities, Minneapolis, USA.'}, {'ForeName': 'Francis S', 'Initials': 'FS', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, NY, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, USA.'}, {'ForeName': 'Cheri A', 'Initials': 'CA', 'LastName': 'Levinson', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, USA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'McConnell', 'Affiliation': 'Menzies Health Institute of Queensland, Brisbane, Australia; School of Medicine, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Plag', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - University Medicine Berlin, Germany.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Pollack', 'Affiliation': 'Department of Psychiatry, Rush University Medical Center, Chicago, USA.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Ressler', 'Affiliation': 'Harvard Medical School, Boston, USA; McLean Hospital, Belmont, USA.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Rodebaugh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - University Medicine Berlin, Germany.'}, {'ForeName': 'Candyce D', 'Initials': 'CD', 'LastName': 'Tart', 'Affiliation': 'New Mexico VA Health Care System, Albuquerque, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Tolin', 'Affiliation': 'The Institute of Living, Hartford, USA; Yale University School of Medicine, New Haven, USA.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'van Minnen', 'Affiliation': 'Behavioral Science Institute, Radboud University Nijmegen, The Netherlands.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Waters', 'Affiliation': 'School of Applied Psychology, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Carl F', 'Initials': 'CF', 'LastName': 'Weems', 'Affiliation': 'Department of Human Development and Family Studies, Iowa State University, Ames, USA.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, USA; Harvard Medical School, Boston, USA.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wyka', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, NY, USA; City University of New York Graduate School of Public Health and Health Policy, New York, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Altemus', 'Affiliation': 'Yale University School of Medicine, New Haven, USA.'}, {'ForeName': 'Page', 'Initials': 'P', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychology, Georgia State University, Atlanta, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Cukor', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, NY, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Finck', 'Affiliation': 'DRK Kliniken Berlin Wiegmann Klinik, Berlin, Germany.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Geffken', 'Affiliation': 'Geffken Group, PLLC, Gainesville, FL, USA.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Golfels', 'Affiliation': 'Woltersdorf Hospital, Woltersdorf, Germany.'}, {'ForeName': 'Wayne K', 'Initials': 'WK', 'LastName': 'Goodman', 'Affiliation': 'Department of Psychiatry, Baylor College of Medicine, USA.'}, {'ForeName': 'Cassidy A', 'Initials': 'CA', 'LastName': 'Gutner', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, USA.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Heyman', 'Affiliation': 'Great Ormond Street Hospital for Children, London, UK; University College, London, UK.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Jovanovic', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Adam B', 'Initials': 'AB', 'LastName': 'Lewin', 'Affiliation': 'Department of Pediatrics, University of South Florida, Tampa, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, USA.'}, {'ForeName': 'Tanya K', 'Initials': 'TK', 'LastName': 'Murphy', 'Affiliation': 'Department of Pediatrics, University of South Florida, Tampa, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Norrholm', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thuras', 'Affiliation': 'Department of Psychiatry, University of Minnesota-Twin Cities, Minneapolis, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Turner', 'Affiliation': 'Primary Care Clinical Unit, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, USA.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102149']
3397,31488307,3-Year Clinical Outcomes of the PRISON-IV Trial: Ultrathin Struts Versus Conventional Drug-Eluting Stents in Total Coronary Occlusions.,,2019,,['Total Coronary Occlusions'],['Ultrathin Struts Versus Conventional Drug-Eluting Stents'],[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0151814', 'cui_str': 'Coronary Occlusion'}]","[{'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]",[],,0.030361,,"[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Zivelonghi', 'Affiliation': ''}, {'ForeName': 'Pierfrancesco', 'Initials': 'P', 'LastName': 'Agostoni', 'Affiliation': ''}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Teeuwen', 'Affiliation': ''}, {'ForeName': 'Renè J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': ''}, {'ForeName': 'Josè P S', 'Initials': 'JPS', 'LastName': 'Henriques', 'Affiliation': ''}, {'ForeName': 'Paul H M J', 'Initials': 'PHMJ', 'LastName': 'Vermeersch', 'Affiliation': ''}, {'ForeName': 'Mike A R', 'Initials': 'MAR', 'LastName': 'Bosschaert', 'Affiliation': ''}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Kelder', 'Affiliation': ''}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': ''}, {'ForeName': 'Maarten J', 'Initials': 'MJ', 'LastName': 'Suttorp', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.05.044']
3398,30926995,Tackling the outcome bias related to the effectiveness of antibiotics against the common cold: results of a randomized controlled trial applying the Solomon four-group design.,"In recent years, antimicrobial resistance (AMR) has become an international public health priority. In the area of human medicine, the mis- and overuse of antibiotics is an important contributor to the development of AMR. Such a non-prudent use of antibiotics is especially prevalent in the treatment of viral infections such as the common cold. The present study aims to address the misconception, also known as outcome bias, that antibiotics may be an effective treatment against the common cold by providing a ""debiasing"" risk communication intervention. It aims at conveying the non-existence of a cause-effect relationship between antibiotics and the reduction of cold-related symptoms through a visual aid and simple explanatory text. A Solomon four-group design was employed to test for within- and between-subjects effects of the intervention as well as potential sensitization effects of the repeated measurement. A total of 311 participants residing in Germany were randomly assigned to receiving (1) a pretest, the debiasing intervention and post-test (2), a pretest, a control stimulus and post-test (3), the debiasing intervention and post-test, or (4) the post-test only. Outcome measures included knowledge about the effectiveness of antibiotics, the attitude toward using it as treatment against the common cold and the evaluation of a scenario describing an irresponsible use of antibiotics. Within-subjects comparisons found that participants receiving the pre- and post-test and intervention showed improved knowledge (t(77) = -2.53, p = .014), attitude (t(77) = -2.09, p = .040), and evaluation measures (t(77) = -2.23, p = .028). The pretest might, however, have caused a sensitization of participants for knowledge-related questions (t(77) = 2.207, p = .029). Between-subjects comparisons found differences in knowledge levels between the post-test only group and both groups receiving the intervention (F(3, 307) = 5.63, p = .001, η2p = .05]. There were no differences between the intervention and control groups with regard to attitude and evaluation of the scenario. While the risk communication intervention led to an increase in knowledge, the outcomes related to attitude and evaluation of a scenario were only affected positively in one group. Therefore, it seems that communication interventions based on visual aids are a simple method to promote the understanding of the true relationship between antibiotic treatment and the decrease of cold-related symptoms. Variables such as attitude and evaluation of a scenario presenting the irresponsible use of antibiotics require, however, additional interventions facilitating a translation of accurate understanding into respective attitudes and judgments.",2020,There were no differences between the intervention and control groups with regard to attitude and evaluation of the scenario.,['311 participants residing in Germany'],[],"['knowledge levels', 'knowledge about the effectiveness of antibiotics, the attitude toward using it as treatment against the common cold and the evaluation of a scenario describing an irresponsible use of antibiotics']","[{'cui': 'C0017480', 'cui_str': 'Germany'}]",[],"[{'cui': 'C0871796', 'cui_str': 'Knowledge level'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0521124', 'cui_str': 'Against (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",311.0,0.0296454,There were no differences between the intervention and control groups with regard to attitude and evaluation of the scenario.,"[{'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Ludolph', 'Affiliation': 'Institute of Communication and Health, Faculty of Communication Sciences, University of Lugano (Università della Svizzera italiana), Via G. Lugano, Switzerland.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Schulz', 'Affiliation': 'Institute of Communication and Health, Faculty of Communication Sciences, University of Lugano (Università della Svizzera italiana), Via G. Lugano, Switzerland.'}]",Translational behavioral medicine,['10.1093/tbm/iby122']
3399,31838257,Mobility and outcomes for validated evidence - Incentive trial (MOVE IT): Randomized clinical trial study protocol.,,2020,,[],['validated evidence - Incentive trial (MOVE IT'],[],[],"[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0578671', 'cui_str': 'Does move (finding)'}]",[],,0.241525,,"[{'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Greysen', 'Affiliation': 'Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA. Electronic address: hgreysen@upenn.edu.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reale', 'Affiliation': 'University of Pennsylvania Health System, Nudge Unit, Philadelphia, PA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Mercede', 'Affiliation': 'University of Pennsylvania Health System, Nudge Unit, Philadelphia, PA, USA.'}, {'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA; University of Pennsylvania Health System, Nudge Unit, Philadelphia, PA, USA; University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA; University of Pennsylvania, Wharton School, Philadelphia, PA, USA.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Small', 'Affiliation': 'University of Pennsylvania, Wharton School, Philadelphia, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Snider', 'Affiliation': 'University of Pennsylvania Health System, Nudge Unit, Philadelphia, PA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Rareshide', 'Affiliation': 'University of Pennsylvania Health System, Nudge Unit, Philadelphia, PA, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Halpern', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'S Ryan', 'Initials': 'SR', 'LastName': 'Greysen', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105911']
3400,32072863,"Assessing YouTube science news' credibility: The impact of web-search on the role of video, source, and user attributes.","This randomized controlled experiment ( N  = 707) is the first to examine the role of video, source and user attributes in credibility assessment of online science news videos, and the impact of web-search on this role. We created a science news YouTube video in 12 versions (3 × 2 × 2 for source, quality and popularity). Each participant was randomly assigned to one version and was asked to rate the credibility of the source and the scientific information presented in the video. We found that perceived credibility is positively associated with perceived quality, as well as users' YouTube experience. For those participants who did not conduct an online search during the assessment task, there was a positive association between the presenter's perceived credibility and the video's perceived credibility as well as its popularity; however, such associations were not present for participants who did conduct an online search.",2020,"For those participants who did not conduct an online search during the assessment task, there was a positive association between the presenter's perceived credibility and the video's perceived credibility as well as its popularity; however, such associations were not present for participants who did conduct an online search.",[],[],[],[],[],[],,0.0474704,"For those participants who did not conduct an online search during the assessment task, there was a positive association between the presenter's perceived credibility and the video's perceived credibility as well as its popularity; however, such associations were not present for participants who did conduct an online search.","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Michalovich', 'Affiliation': 'University of British Columbia, Canada.'}, {'ForeName': 'Arnon', 'Initials': 'A', 'LastName': 'Hershkovitz', 'Affiliation': 'Tel Aviv University, Israel.'}]","Public understanding of science (Bristol, England)",['10.1177/0963662520905466']
3401,21149431,Intercenter differences in bronchopulmonary dysplasia or death among very low birth weight infants.,"OBJECTIVES


To determine (1) the magnitude of clustering of bronchopulmonary dysplasia (36 weeks) or death (the outcome) across centers of the Eunice Kennedy Shriver National Institute of Child and Human Development National Research Network, (2) the infant-level variables associated with the outcome and estimate their clustering, and (3) the center-specific practices associated with the differences and build predictive models.
METHODS


Data on neonates with a birth weight of <1250 g from the cluster-randomized benchmarking trial were used to determine the magnitude of clustering of the outcome according to alternating logistic regression by using pairwise odds ratio and predictive modeling. Clinical variables associated with the outcome were identified by using multivariate analysis. The magnitude of clustering was then evaluated after correction for infant-level variables. Predictive models were developed by using center-specific and infant-level variables for data from 2001 2004 and projected to 2006.
RESULTS


In 2001-2004, clustering of bronchopulmonary dysplasia/death was significant (pairwise odds ratio: 1.3; P < .001) and increased in 2006 (pairwise odds ratio: 1.6; overall incidence: 52%; range across centers: 32%-74%); center rates were relatively stable over time. Variables that varied according to center and were associated with increased risk of outcome included lower body temperature at NICU admission, use of prophylactic indomethacin, specific drug therapy on day 1, and lack of endotracheal intubation. Center differences remained significant even after correction for clustered variables.
CONCLUSION


Bronchopulmonary dysplasia/death rates demonstrated moderate clustering according to center. Clinical variables associated with the outcome were also clustered. Center differences after correction of clustered variables indicate presence of as-yet unmeasured center variables.",2011,"In 2001-2004, clustering of bronchopulmonary dysplasia/death was significant (pairwise odds ratio: 1.3; P < .001) and increased in 2006 (pairwise odds ratio: 1.6; overall incidence: 52%; range across centers: 32%-74%); center rates were relatively stable over time.","['Data on neonates with a birth weight of <1250 g from the cluster-randomized benchmarking trial', 'very low birth weight infants']",[],"['lower body temperature at NICU admission, use of prophylactic indomethacin, specific drug therapy on day 1, and lack of endotracheal intubation', 'bronchopulmonary dysplasia or death', 'bronchopulmonary dysplasia/death']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}]",[],"[{'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.101137,"In 2001-2004, clustering of bronchopulmonary dysplasia/death was significant (pairwise odds ratio: 1.3; P < .001) and increased in 2006 (pairwise odds ratio: 1.6; overall incidence: 52%; range across centers: 32%-74%); center rates were relatively stable over time.","[{'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL 35249, USA. ambal@uab.edu'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Georgiy', 'Initials': 'G', 'LastName': 'Bobashev', 'Affiliation': ''}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': ''}, {'ForeName': 'Burton', 'Initials': 'B', 'LastName': 'Levine', 'Affiliation': ''}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': ''}, {'ForeName': 'Rosemary D', 'Initials': 'RD', 'LastName': 'Higgins', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatrics,['10.1542/peds.2010-0648']
3402,29652596,Effect of Concurrent Visual Feedback Frequency on Postural Control Learning in Adolescents.,"The purpose was to find better augmented visual feedback frequency (100% or 67%) for learning a balance task in adolescents. Thirty subjects were divided randomly into a control group, and 100% and 67% feedback groups. The three groups performed pretest (3 trials), practice (12 trials), posttest (3 trials) and retention (3 trials, 24 hours later). The reduced feedback group showed lower RMS in the posttest than in the pretest (p = 0.04). The control and reduced feedback groups showed significant lower median frequency in the posttest than in the pretest (p < 0.05). Both feedback groups showed lower values in retention than in the pretest (p < 0.05). Even when the effect of feedback frequency could not be detected in motor learning, 67% of the feedback was recommended for motor adaptation.",2019,The control and reduced feedback groups showed significant lower median frequency in the posttest than in the pretest (p < 0.05).,"['Thirty subjects', 'Adolescents', 'adolescents']",['Concurrent Visual Feedback Frequency'],"['median frequency', 'RMS', 'visual feedback frequency', 'Postural Control Learning']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",30.0,0.0162787,The control and reduced feedback groups showed significant lower median frequency in the posttest than in the pretest (p < 0.05).,"[{'ForeName': 'Adrià', 'Initials': 'A', 'LastName': 'Marco-Ahulló', 'Affiliation': 'a Departamento de Didáctica de la Expresión Musical, Plástica y Corporal , Universidad de Valencia , Valencia , España.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Sánchez-Tormo', 'Affiliation': 'a Departamento de Didáctica de la Expresión Musical, Plástica y Corporal , Universidad de Valencia , Valencia , España.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'García-Pérez', 'Affiliation': 'a Departamento de Didáctica de la Expresión Musical, Plástica y Corporal , Universidad de Valencia , Valencia , España.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Villarrasa-Sapiña', 'Affiliation': 'b Departamento de Educación Física y Deportiva , Universidad de Valencia , Valencia , España.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'González', 'Affiliation': 'b Departamento de Educación Física y Deportiva , Universidad de Valencia , Valencia , España.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'García-Massó', 'Affiliation': 'a Departamento de Didáctica de la Expresión Musical, Plástica y Corporal , Universidad de Valencia , Valencia , España.'}]",Journal of motor behavior,['10.1080/00222895.2018.1454397']
3403,32174130,Low-Attenuation Noncalcified Plaque on Coronary Computed Tomography Angiography Predicts Myocardial Infarction: Results From the Multicenter SCOT-HEART Trial (Scottish Computed Tomography of the HEART).,"BACKGROUND


The future risk of myocardial infarction is commonly assessed using cardiovascular risk scores, coronary artery calcium score, or coronary artery stenosis severity. We assessed whether noncalcified low-attenuation plaque burden on coronary CT angiography (CCTA) might be a better predictor of the future risk of myocardial infarction.
METHODS


In a post hoc analysis of a multicenter randomized controlled trial of CCTA in patients with stable chest pain, we investigated the association between the future risk of fatal or nonfatal myocardial infarction and low-attenuation plaque burden (% plaque to vessel volume), cardiovascular risk score, coronary artery calcium score or obstructive coronary artery stenoses.
RESULTS


In 1769 patients (56% male; 58±10 years) followed up for a median 4.7 (interquartile interval, 4.0-5.7) years, low-attenuation plaque burden correlated weakly with cardiovascular risk score ( r =0.34;  P <0.001), strongly with coronary artery calcium score ( r =0.62;  P <0.001), and very strongly with the severity of luminal coronary stenosis (area stenosis,  r =0.83;  P <0.001). Low-attenuation plaque burden (7.5% [4.8-9.2] versus 4.1% [0-6.8];  P <0.001), coronary artery calcium score (336 [62-1064] versus 19 [0-217] Agatston units;  P <0.001), and the presence of obstructive coronary artery disease (54% versus 25%;  P <0.001) were all higher in the 41 patients who had fatal or nonfatal myocardial infarction. Low-attenuation plaque burden was the strongest predictor of myocardial infarction (adjusted hazard ratio, 1.60 (95% CI, 1.10-2.34) per doubling;  P =0.014), irrespective of cardiovascular risk score, coronary artery calcium score, or coronary artery area stenosis. Patients with low-attenuation plaque burden greater than 4% were nearly 5 times more likely to have subsequent myocardial infarction (hazard ratio, 4.65; 95% CI, 2.06-10.5;  P <0.001).
CONCLUSIONS


In patients presenting with stable chest pain, low-attenuation plaque burden is the strongest predictor of fatal or nonfatal myocardial infarction. These findings challenge the current perception of the supremacy of current classical risk predictors for myocardial infarction, including stenosis severity. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01149590.",2020,,['Myocardial Infarction'],[],[],"[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",[],[],,0.0330488,,"[{'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kwiecinski', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Mhairi', 'Initials': 'M', 'LastName': 'Doris', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'McElhinney', 'Affiliation': 'Cedars-Sinai Medical Centre, Los Angeles, CA (P.M., S.C., P.J.S., D.S.B., D.D.).'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': ""D'Souza"", 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Cadet', 'Affiliation': 'Cedars-Sinai Medical Centre, Los Angeles, CA (P.M., S.C., P.J.S., D.S.B., D.D.).'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Moss', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Shirjel', 'Initials': 'S', 'LastName': 'Alam', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hunter', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Pawade', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Chengjia', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Weir McCall', 'Affiliation': 'University of Cambridge, United Kingdom (J.W.M.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bonnici-Mallia', 'Affiliation': 'Department of Radiology, Ninewells Hospital, Dundee, United Kingdom (M.B-M., C.M.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Murrills', 'Affiliation': 'Department of Radiology, Ninewells Hospital, Dundee, United Kingdom (M.B-M., C.M.).'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Roditi', 'Affiliation': 'Institute of Clinical Sciences, University of Glasgow, United Kingdom (G.R.).'}, {'ForeName': 'Edwin J R', 'Initials': 'EJR', 'LastName': 'van Beek', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': 'Weill Cornell Medical College, New York, NY (L.J.S.).'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Nicol', 'Affiliation': 'Royal Brompton and Harefield NHS Foundation Trust Departments of Cardiology and Radiology; and the National Heart and Lung Institute, Faculty of Medicine, Imperial College, London, United Kingdom (E.D.N.).'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Berman', 'Affiliation': 'Cedars-Sinai Medical Centre, Los Angeles, CA (P.M., S.C., P.J.S., D.S.B., D.D.).'}, {'ForeName': 'Piotr J', 'Initials': 'PJ', 'LastName': 'Slomka', 'Affiliation': 'Cedars-Sinai Medical Centre, Los Angeles, CA (P.M., S.C., P.J.S., D.S.B., D.D.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Damini', 'Initials': 'D', 'LastName': 'Dey', 'Affiliation': 'Cedars-Sinai Medical Centre, Los Angeles, CA (P.M., S.C., P.J.S., D.S.B., D.D.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.044720']
3404,32228328,Not All Green Is Tophi: The Importance of Optimizing Minimum Attenuation and Using a Tin Filter to Minimize Clumpy Artifacts on Foot and Ankle Dual-Energy CT.,"OBJECTIVE.  The clumpy artifact has a high misdiagnosis rate, but the artifact has not been well studied. The aims of this study were to evaluate the frequency and location of clumpy artifacts, the rate of misdiagnosis of clumpy artifacts as gout, and the effects of raising the minimum attenuation value and using a selective photon shield in dual-energy CT (DECT).  MATERIALS AND METHODS.  Forty patients without gout who underwent foot and ankle DECT were enrolled in this study. Images in both sets were randomly assigned a minimum attenuation of 130 HU or 150 HU. Three radiologists independently checked all images for presence, volume, and location of green color-coded pixelation and graded their findings according to a 4-point confidence scale, frequency, and volume. Misdiagnosis rate and misdiagnosis score were compared using the Wilcoxon signed rank and McNemar tests.  RESULTS.  In set 1, the frequency of clumpy artifacts in DECT with the minimum attenuation set to 130 HU and 150 HU were 81% and 68%, respectively. For all three readers, the misdiagnosis rate and misdiagnosis score decreased when changing the minimum attenuation from 130 HU to 150 HU. In set 2, with the minimum attenuation set to 130 HU, the frequency of the clumpy artifact was 44%; with the minimum attenuation set to 150 HU, no clumpy artifacts were seen.  CONCLUSION.  Clumpy artifacts occurred frequently in DECT without a tin filter. Setting the minimum attenuation to the higher value of 150 HU reduced the frequency of clumpy artifacts, and adding a tin filter to DECT greatly reduced their occurrence.",2020,"For all three readers, the misdiagnosis rate and misdiagnosis score decreased when changing the minimum attenuation from 130 HU to 150 HU.",['Forty patients without gout who underwent foot and ankle DECT'],['DECT'],"['Misdiagnosis rate and misdiagnosis score', 'misdiagnosis rate and misdiagnosis score', 'Clumpy artifacts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}]",[],"[{'cui': 'C0679838', 'cui_str': 'Misdiagnosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085089', 'cui_str': 'Artifacts'}]",40.0,0.0186423,"For all three readers, the misdiagnosis rate and misdiagnosis score decreased when changing the minimum attenuation from 130 HU to 150 HU.","[{'ForeName': 'Eun Hae', 'Initials': 'EH', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Chonbuk National University Medical School, Jeonju, Republic of Korea.'}, {'ForeName': 'Wan-Hee', 'Initials': 'WH', 'LastName': 'Yoo', 'Affiliation': 'Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'You Seon', 'Initials': 'YS', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Pusan National University Hospital, Biomedical Research Institute, Pusan, Republic of Korea.'}, {'ForeName': 'Jung Hee', 'Initials': 'JH', 'LastName': 'Byon', 'Affiliation': 'Department of Radiology, Chonbuk National University Medical School, Jeonju, Republic of Korea.'}, {'ForeName': 'Jongjun', 'Initials': 'J', 'LastName': 'Pak', 'Affiliation': 'Siemens Healthineers Ltd., Diagnostic Imaging Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Yunjung', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Republic of Korea.'}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22222']
3405,30872183,"Regarding ""Paracervical Block as a Strategy to Reduce Postoperative Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial"".",,2019,,[],['Laparoscopic Hysterectomy'],['Postoperative Pain'],[],"[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",,0.357147,,"[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Lovett-Carter', 'Affiliation': 'Providence, RI.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2019.02.018']
3406,31877377,"Contribution of Vision, Touch, and Hearing to the Use of Sham Devices in Acupuncture-Related Studies.","This study investigates whether visual deprivation influences participants' accuracy in differentiating between real and sham acupuncture needles. It also evaluates the relative contributions of tactile, visual, and auditory cues that participants use in their decision-making processes. In addition, a simple sensory decision-making model for research using acupuncture sham devices as comparative controls is proposed. Forty healthy individuals underwent two conditions (blindfolded and sighted) in random sequence. Four sham and four real needles were randomly applied to the participants' lower limb acupoints (ST32 to ST39). Participants responded which needle type was applied. Participants then verbally answered a questionnaire on which sensory cues influenced their decision-making. The proportion of correct judgments, P(C), was calculated to indicate the participants' accuracy in distinguishing between the needle types. Visual deprivation did not significantly influence the participants' discrimination accuracy. Tactile cues were the dominant sensory modality used in decision-making, followed by visual and auditory cues. Sharp and blunt sensations were associated with the real and sham needles, respectively, for both conditions. This study confirmed that tactile cues were the main sensory modalities used in participant decision-making during acupuncture administration. Also, short-term blindfolding of participants during procedures will unlikely influence blinding effectiveness. CLINICAL TRIAL REGISTRATION NUMBER: Not applicable. This study does not fall under the definition of a clinical trial under the ICMJE guidelines.",2020,"The proportion of correct judgements, P(C), was calculated to indicate the participants' accuracy of in distinguishing between the needle types.",['Forty healthy individuals underwent two conditions (blindfolded and sighted) in random sequence'],"['visual deprivation', 'limb acupoints (ST32 to ST39']","['Sharp and blunt sensations', 'proportion of correct judgements, P(C', 'Tactile cues', 'Visual deprivation']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0450529', 'cui_str': 'ST32 (body structure)'}, {'cui': 'C0450536', 'cui_str': 'ST39 (body structure)'}]","[{'cui': 'C1444775', 'cui_str': 'Sharp'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C0439815', 'cui_str': 'Tactile (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]",40.0,0.096705,"The proportion of correct judgements, P(C), was calculated to indicate the participants' accuracy of in distinguishing between the needle types.","[{'ForeName': 'Chee-Wee', 'Initials': 'CW', 'LastName': 'Tan', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, United Kingdom. Electronic address: cheewee.tan@gcu.ac.uk.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Santos', 'Affiliation': 'School of Health Sciences, Queen Margaret University, Edinburgh, United Kingdom.'}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2019.12.003']
3407,31407775,The Effects of Vibration and Pressure Treatments in the Early Postoperative Period of Rhinoplasty.,"BACKGROUND


The early postoperative period can be distressing for the patients undergoing rhinoplasty since edema and ecchymosis are common complications.
OBJECTIVES


To analyze the effects of the vibration and pressure treatments in the early postoperative period of rhinoplasty.
METHODS


Sixty patients, who had undergone rhinoplasty, were randomized into 3 groups: group 1 (control group, n = 20) received classic nasal casting, group 2 (n = 20) received nasal cast with an elastic bandage to hold it on the face, and group 3 (n = 20) received vibration treatment in addition to that in group 2 following the rhinoplasty. They were evaluated preoperatively and postoperatively at 3 and 7 days in a prospective study. The postoperative edema and ecchymosis were scored by 2 independent surgeons. The postoperative pain was measured using the visual analog scale, and the necessity of anti-inflammatory medication (and the dose needed) and the cast comfort was questioned. The sebaceous activity of the nose skin was examined. A preoperative and postoperative seventh day sonographic study was performed to evaluate the tissue edema objectively.
RESULTS


The pressure treatment decreased the edema and ecchymosis significantly compared with the control group. The vibration treatment minimized edema, ecchymosis, sebaceous activity of the nose skin, pain score, and the need for anti-inflammatory medication, and increased the cast comfort significantly compared with the other groups (P < 0.0001).
CONCLUSIONS


Rapid regression of edema and ecchymosis may be achieved using the vibrating nasal cast technique that may minimize patient discomfort, pain, and sebaceous activity following rhinoplasty.
LEVEL OF EVIDENCE: 1


",2020,"The vibration treatment minimized edema, ecchymosis, sebaceous activity of the nose skin, pain score, and the need for anti-inflammatory medication, and increased the cast comfort significantly compared with the other groups (p < 0.0001).
","['Sixty patients, who had undergone rhinoplasty', 'Early Postoperative Period of Rhinoplasty']","['vibration treatment', 'Vibration and Pressure Treatments', 'classic nasal casting', 'nasal cast with an elastic bandage']","['cast comfort', 'postoperative pain', 'postoperative edema and ecchymosis', 'edema, ecchymosis, sebaceous activity of the nose skin, pain score, and the need for anti-inflammatory medication', 'tissue edema objectively', 'edema and ecchymosis', 'sebaceous activity of the nose skin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment (regime/therapy)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0336591', 'cui_str': 'Elastic bandage'}]","[{'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0028429', 'cui_str': 'Nose'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]",60.0,0.0139174,"The vibration treatment minimized edema, ecchymosis, sebaceous activity of the nose skin, pain score, and the need for anti-inflammatory medication, and increased the cast comfort significantly compared with the other groups (p < 0.0001).
","[{'ForeName': 'Süleyman', 'Initials': 'S', 'LastName': 'Taş', 'Affiliation': ''}]",Aesthetic surgery journal,['10.1093/asj/sjz226']
3408,31387013,The effects of shame on subsequent reactions to a trauma analog.,"The current study examined the effects of experimentally-induced shame on subsequent reactions to a trauma analog. Participants were 88 college-aged women randomly assigned to a shame prime condition or to a control (neutral) condition. Participants then were presented with an analog trauma audiotape depicting dating violence. Participants reported intrusive thoughts relating to the trauma analog in the two days following the procedure. Negative (shame, guilt) and positive (pride, positive affect) emotions were monitored throughout the procedure. Results indicated that the shame prime successfully increased shame in the Shame condition alone. After the trauma analog, increases in shame were noted in both conditions. In contrast, guilt reduced in the Shame condition, while this emotion increased in the Control condition, contrary to hypothesis. Shame and guilt were somewhat volatile for participants in the Shame condition in the two days following the lab procedure, while individuals in the Control condition reported steadily decreasing levels of these emotions. No between-condition differences were noted in the frequency of intrusions in the two days following the laboratory procedure, contrary to hypothesis. Results are discussed in light of our current understanding of shame and its role in PTSD, with suggestions to guide future research.",2019,"Shame and guilt were somewhat volatile for participants in the Shame condition in the two days following the lab procedure, while individuals in the Control condition reported steadily decreasing levels of these emotions.","['Participants then were presented with an analog trauma audiotape depicting dating violence', 'Participants were 88 college-aged women randomly assigned to a']",['shame prime condition or to a control (neutral) condition'],"['Shame and guilt', 'shame', 'Negative (shame, guilt) and positive (pride, positive affect) emotions']","[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0004295', 'cui_str': 'Audiotapes'}, {'cui': 'C4046106', 'cui_str': 'Dating Violence'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",,0.0232906,"Shame and guilt were somewhat volatile for participants in the Shame condition in the two days following the lab procedure, while individuals in the Control condition reported steadily decreasing levels of these emotions.","[{'ForeName': 'J Gayle', 'Initials': 'JG', 'LastName': 'Beck', 'Affiliation': 'Department of Psychology, The University of Memphis, United States. Electronic address: jgbeck@memphis.edu.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Dodson', 'Affiliation': 'Department of Psychology, The University of Memphis, United States.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Pickover', 'Affiliation': 'Department of Psychology, The University of Memphis, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Woodward', 'Affiliation': 'Department of Psychological Sciences, Western Kentucky University, United States.'}, {'ForeName': 'Alexandra J', 'Initials': 'AJ', 'LastName': 'Lipinski', 'Affiliation': 'Department of Psychology, The University of Memphis, United States.'}, {'ForeName': 'Han N', 'Initials': 'HN', 'LastName': 'Tran', 'Affiliation': 'Department of Psychology, The University of Memphis, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102108']
3409,31407484,Perioperative analgesia with parecoxib sodium improves postoperative pain and immune function in patients undergoing hepatectomy for hepatocellular carcinoma.,"RATIONALE, AIMS, AND OBJECTIVES


Acute postoperative pain can result in immune dysfunction, which can be partly mitigated by efficient pain management. Opioids that have been widely applied to analgesia have been shown to suppress immune function, which has a negative impact on the treatment of patients with cancer. This study investigated the effects of perioperative fentanyl analgesia alone or in combination with parecoxib sodium on postoperative pain, immune function, and prognosis in patients undergoing hepatectomy of hepatocellular carcinoma (HCC).
METHODS


A total of 80 patients scheduled for hepatectomy between October 2013 and August 2014 were included. Patients were randomly divided into two groups (n = 40) and allocated to receive parecoxibsodium 40 mg (group P) or placebo (group C) 30 minutes before induction of anaesthesia, followed by 40 mg every 12 hours for 48 hours after the operation. All patients had access to patient-controlled analgesia with intravenous fentanylpostoperatively. Venous blood samples were collected at the following time points: 30 minutes before induction of anaesthesia (T0), the end of the surgery (T1), 24 hours after surgery (T2), and 72 hours after surgery (T3). The percentages of CD3+, CD4+, CD8+, CD4+/CD8+ T cells, and CD3+CD16+CD56+ (NK) cells at these time points were quantified by flow cytometry (FCM).Visual analogue scale (VAS) scores, total fentanyl consumption, and adverse effects were recorded. The prognostic differences in overall survival (OS) and disease-free survival (DFS) between the two groups was also investigated.
RESULTS


For both groups, the percentages of CD3+, CD4+ T cells, and the ratio of CD4+/CD8+ significantly decreased at T1 and T2 (P < .05). The percentages of CD3+ T cells were significantly lower in group C than that in group P at T2 (P < .05). In group C, the amount of CD3+ T cells was lower at T3 compared with T0 (P < .05). The percentages of NK cells significantly decreased at T1 in both groups (P < .05). The percentages of NK in group P were recovered nearly to baseline (T0) at T2, which was higher than that of group C (P < .05). In group C, the percentages of NK cells have not recovered nearly to baseline at T3 compared with T0 (P < .05). VAS scores at rest and on cough in group P were significantly lower than those in group C at 2, 6, 12, and 24 hours after operation (P < .05), and there were no significant differences in VAS scores between the two groups at 48 hours after surgery (P > .05). There were no significant differences regarding the incidence of adverse effects between the two groups (P > .05). Kaplan-Meier analysis indicated that the DFS time in group P was significantly longer than in group C (19.0 months, 95% confidence interval [CI], 9.8-28.2 vs 14.0 months, 95% CI, 8.1-19.9; P < .05). There was no significant difference in OS time (36.0 months, 95% CI, 13.4-58.9 vs 14.0 months, 95% CI, 10.6-25.4; P > .05) between two groups.
CONCLUSIONS


The present study indicated that perioperative analgesia of parecoxib sodium combined with patient-controlled analgesic fentanyl resulted in better preserved immune function with enhancement of the analgesic efficacy to fentanyl alone of HCC patients undergoing hepatectomy and helped postpone postoperative tumour recurrence.",2020,"In group C, the amount of CD3+ T cells was lower at T3 compared with T0 (P < .05).","['80 patients scheduled for hepatectomy between October 2013 and August 2014 were included', 'patients undergoing hepatectomy for hepatocellular carcinoma', 'All patients had access to patient-controlled analgesia with intravenous fentanylpostoperatively', 'patients with cancer', 'patients undergoing hepatectomy of hepatocellular carcinoma (HCC', 'HCC patients undergoing hepatectomy and helped postpone postoperative tumour recurrence']","['parecoxib sodium combined with patient-controlled analgesic fentanyl', 'parecoxibsodium 40 mg (group P) or placebo', 'parecoxib sodium']","['percentages of CD3+, CD4+, CD8+, CD4+/CD8+ T cells, and CD3+CD16+CD56+ (NK) cells', 'overall survival (OS) and disease-free survival (DFS', 'postoperative pain, immune function, and prognosis', 'amount of CD3+ T cells', 'analgesic efficacy', 'flow cytometry (FCM).Visual analogue scale (VAS) scores, total fentanyl consumption, and adverse effects', 'percentages of CD3+, CD4+ T cells, and the ratio of CD4+/CD8', 'VAS scores', 'DFS time', 'Venous blood samples', 'OS time', 'percentages of CD3+ T cells', 'VAS scores at rest and on cough', 'percentages of NK cells', 'postoperative pain and immune function', 'incidence of adverse effects']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]","[{'cui': 'C0915144', 'cui_str': 'parecoxib sodium'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0016263', 'cui_str': 'Flow Microfluorimetry'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",2014.0,0.0561692,"In group C, the amount of CD3+ T cells was lower at T3 compared with T0 (P < .05).","[{'ForeName': 'Run-Dong', 'Initials': 'RD', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatic Surgery, The First Affiliated Hospital of USTC, Hefei, China.'}, {'ForeName': 'Jian-Yu', 'Initials': 'JY', 'LastName': 'Zhu', 'Affiliation': 'Department of Trauma Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Hepatic Surgery, The First Affiliated Hospital of USTC, Hefei, China.'}, {'ForeName': 'Yong-Sheng', 'Initials': 'YS', 'LastName': 'Ge', 'Affiliation': 'Department of Hepatic Surgery, The First Affiliated Hospital of USTC, Hefei, China.'}, {'ForeName': 'Ge-Liang', 'Initials': 'GL', 'LastName': 'Xu', 'Affiliation': 'Department of Hepatic Surgery, The First Affiliated Hospital of USTC, Hefei, China.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Jia', 'Affiliation': 'Department of Hepatic Surgery, The First Affiliated Hospital of USTC, Hefei, China.'}]",Journal of evaluation in clinical practice,['10.1111/jep.13256']
3410,32118607,CORR Insights®: Did Osteoblastic Cell Therapy Improve the Prognosis of Pre-fracture Osteonecrosis of the Femoral Head? A Randomized Controlled Trial.,,2020,,[],"['CORR Insights®', 'Osteoblastic Cell Therapy']",[],[],"[{'cui': 'C0302189', 'cui_str': 'Cell Therapy'}]",[],,0.233149,,"[{'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Meermans', 'Affiliation': 'G. Meermans, Orthopaedic Surgeon, Bravis Hospital, Department of Orthopaedics, Bergen Op Zoom, Brabant, Netherlands.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001194']
3411,31331773,"Immunogenicity and safety of a liquid Pentavalent (DTwP-Hb-Hib) combination vaccine manufactured by Human Biologicals Institute in 6-8 weeks old healthy infants: A phase III, randomized, single blind, non-inferiority study.","BACKGROUND


A liquid Pentavalent (DTwP-Hb-Hib) combination vaccine, developed by Human Biologicals Institute, underwent a Phase III clinical study in India. In this randomized, single blind, non-inferiority study, the immunogenicity and safety of this Investigational vaccine was compared with Pentavac SD® vaccine in 6-8 weeks old healthy infants.
METHODS


A total of 405 healthy infants aged 6-8 weeks old were randomized in 2:1 ratio to receive three doses of either the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine or Pentavac SD® vaccine at four to six weeks interval. Immunogenicity was compared by estimation of antibody titers before the first dose and 4-6 weeks after the third dose of vaccination. Safety of each vaccine was assessed and compared by collection of data on solicited and unsolicited adverse events throughout the study period.
RESULTS


Out of a total of 405 enrolled subjects, 387 subjects completed the study. The seroconversion rates, seroprotection rates and geometric mean titres of the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine group were found to be comparable and non-inferior to the Pentavac SD® vaccine group at 4-6 weeks after the third dose of vaccination. Pain, erythema and swelling at the site of injection were found to be the most common local adverse events whereas fever, irritability and unusual crying were found to be the most common systemic adverse events in both the vaccine groups. No vaccine related serious adverse event was reported. In this study, both the Investigational vaccine as well as the Comparator vaccine were found to be immunogenic and well tolerated.
CONCLUSION


After assessment of the results of the study it was concluded that the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine developed by Human Biologicals Institute was immunogenic and safe when administered to infants aged 6-8 weeks and was non-inferior in immunogenicity and safety to Pentavac SD® vaccine. Clinical Trial Registry of India Identifier: CTRI/2016/01/006541.",2019,"Pain, erythema and swelling at the site of injection were found to be the most common local adverse events whereas fever, irritability and unusual crying were found to be the most common systemic adverse events in both the vaccine groups.","['405 enrolled subjects, 387 subjects completed the study', '405 healthy infants aged 6-8\u202fweeks old', '6-8\u202fweeks old healthy infants']","['Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine', 'Pentavac SD® vaccine', 'liquid Pentavalent (DTwP-Hb-Hib) combination vaccine manufactured', 'liquid Pentavalent (DTwP-Hb-Hib) combination vaccine', 'Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine or Pentavac SD® vaccine']","['fever, irritability and unusual crying', 'immunogenicity and safety', 'Pain, erythema and swelling', 'immunogenic and well tolerated', 'Immunogenicity and safety', 'seroconversion rates, seroprotection rates and geometric mean titres', 'Immunogenicity', 'antibody titers']","[{'cui': 'C4517768', 'cui_str': 'Four hundred and five'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0206253', 'cui_str': 'Vaccines, Combination'}, {'cui': 'C0971597', 'cui_str': 'Pentavac'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}]",405.0,0.264193,"Pain, erythema and swelling at the site of injection were found to be the most common local adverse events whereas fever, irritability and unusual crying were found to be the most common systemic adverse events in both the vaccine groups.","[{'ForeName': 'Sai Krishna', 'Initials': 'SK', 'LastName': 'Susarla', 'Affiliation': 'Human Biologicals Institute, Hyderabad, India. Electronic address: s.saikrishna@indimmune.com.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Community Medicine, School of Public Health, Postgraduate Institute of Medical Education & Research, Chandigarh, India.'}, {'ForeName': 'Mukta', 'Initials': 'M', 'LastName': 'Mantan', 'Affiliation': 'Department of Paediatrics, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Ramchandra', 'Initials': 'R', 'LastName': 'Dhongade', 'Affiliation': 'Department of Paediatrics, Sant Dnyaneshwar Medical Education Research Centre, Pune, India.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Bhave', 'Affiliation': 'Paediatric Research, KEM Hospital Research Centre, Pune, India.'}, {'ForeName': 'Rajat Kumar', 'Initials': 'RK', 'LastName': 'Das', 'Affiliation': 'Department of Paediatrics, KPC Medical College and Hospital, Kolkata, India.'}, {'ForeName': 'Rajib Kumar', 'Initials': 'RK', 'LastName': 'Ray', 'Affiliation': 'Department of Paediatrics, Hi-Tech Medical College and Hospital, Bhubaneswar, India.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ramesh Babu', 'Affiliation': 'Department of Paediatrics, Gandhi Medical College and Hospital, Secunderabad, India.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Ravi', 'Affiliation': 'Department of Paediatrics, JSS Medical College & Hospital, Mysore, India.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Krishnamurthy', 'Affiliation': 'Department of Paediatrics, Mysore Medical College and Research Institute, Mysore, India.'}, {'ForeName': 'Saji', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Pediatrics, Sri Ramachandra Medical Centre, Chennai, India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sandhya', 'Affiliation': 'Human Biologicals Institute, Hyderabad, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Satish', 'Affiliation': 'Human Biologicals Institute, Hyderabad, India.'}, {'ForeName': 'Devi Prasad', 'Initials': 'DP', 'LastName': 'Sahoo', 'Affiliation': 'Human Biologicals Institute, Hyderabad, India.'}]",Vaccine,['10.1016/j.vaccine.2019.06.067']
3412,31194213,Clinical outcome of intracoronary versus intravenous high-dose bolus administration of tirofiban in diabetic patients undergoing primary percutaneous coronary intervention.,"BACKGROUND


Previous trials remain inconsistent regarding the advantages and hazards related to intracoronary (IC) compared with intravenous (IV) administration of thrombolytics. We aimed to evaluate the safety and effectiveness of IC versus IV tirofiban administration in diabetic patients (DM) with acute ST-segment elevation myocardial infarction (STEMI) during primary percutaneous coronary intervention (PCI).
METHODS


This trial included 95 patients who were randomised to high-dose bolus plus a maintenance dose of tirofiban administered either IV or IC. The groups were compared for the incidence of composite major adverse cardiac events (MACE) at 30 days. Levels of cardiac markers were recorded pre- and post-intervention for myocardial perfusion.
RESULTS


The MACE were not different between the groups, but post-procedure myocardial blush grade (MBG) 3 and thrombolysis in myocardial infarction (TIMI) 3 flow were significant in the IC group (p = 0.45, 0.21, respectively), favouring the IC strategy. Peak values of both creatine kinase-muscle/brain (CK-MB) and high-sensitivity troponin T (hs-TnT) were significantly lower in the IC group (155.68 ± 121, 4291 ± 334 ng/dl) versus the IV group (192.4 ± 86, 5342 ± 286 ng/dl) (p = 0.021, p = 0.035, respectively). The peak value was significantly lower in the IC group than the IV group in terms of ST-segment resolution and 30-day left ventricular ejection fraction (LVEF) (p = 0.016 and 0.023, respectively).
CONCLUSION


Thirty days post PCI, IC tirofiban was more efficient in ameliorating blood flow in the coronary arteries and myocardial tissue perfusion in DM patients after STEMI despite bleeding events, and MACE rates showed no significant difference between the groups. The IC group showed better improvement in LVEF.",2019,"The MACE were not different between the groups, but post-procedure myocardial blush grade (MBG) 3 and thrombolysis in myocardial infarction (TIMI) 3 flow were significant in the IC group (p = 0.45, 0.21, respectively), favouring the IC strategy.","['diabetic patients undergoing primary percutaneous coronary intervention', '95 patients', 'diabetic patients (DM) with acute ST-segment elevation myocardial infarction (STEMI) during primary percutaneous coronary intervention (PCI']","['tirofiban administered either IV or IC', 'intracoronary', 'PCI, IC tirofiban', 'tirofiban']","['ST-segment resolution and 30-day left ventricular ejection fraction (LVEF', 'bleeding events, and MACE rates', 'Peak values of both creatine kinase-muscle/brain (CK-MB) and high-sensitivity troponin T (hs-TnT', 'Levels of cardiac markers', 'ameliorating blood flow', 'LVEF', 'incidence of composite major adverse cardiac events (MACE', 'procedure myocardial blush grade (MBG) 3 and thrombolysis in myocardial infarction (TIMI) 3 flow', 'peak value', 'safety and effectiveness']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]","[{'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0429029', 'cui_str': 'ST segment (observable entity)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0523584', 'cui_str': 'Creatine kinase MB measurement'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0041070', 'cui_str': '2,4,6-Trinitrotoluene'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1271630', 'cui_str': 'Cardiac markers'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0005874', 'cui_str': 'Blushings'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",95.0,0.150448,"The MACE were not different between the groups, but post-procedure myocardial blush grade (MBG) 3 and thrombolysis in myocardial infarction (TIMI) 3 flow were significant in the IC group (p = 0.45, 0.21, respectively), favouring the IC strategy.","[{'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Ghonim', 'Affiliation': 'Department of Cardiovascular Medicine, Naser Institute for Research and Therapy, Cairo, Egypt.'}, {'ForeName': 'Abdalla', 'Initials': 'A', 'LastName': 'Mostafa', 'Affiliation': 'Cardiology Department, Menofia University, Almenofia Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Emara', 'Affiliation': 'Cardiology Department, Menofia University, Almenofia Egypt.'}, {'ForeName': 'Alaa S', 'Initials': 'AS', 'LastName': 'Algazzar', 'Affiliation': 'Cardiology Department, Ahmed Maher Teaching Hospital, Cairo, Egypt. Email: goodminds@hotmail.com.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Qutub', 'Affiliation': 'Division of Cardiology, Department of Medicine, King Abdulaziz University Hospital, Jeddah Saudi Arabia.'}]",Cardiovascular journal of Africa,['10.5830/CVJA-2019-027']
3413,32001384,Randomized double blind clinical trial of ABM/P-15 versus allograft in noninstrumented lumbar fusion surgery.,"BACKGROUND CONTEXT


Due to poor bone stock in the elderly, a noninstrumented fusion is commonly performed in Scandinavia when instability is present. Allograft bone is often used as graft extender with consequent low fusion rates. The use of 15 amino acid residue (ABM/P-15) has shown superior fusion rates in dental and cervical spinal surgery but no clinical studies have been conducted in noninstrumented lumbar fusion surgery.
PURPOSE


To evaluate patient reported outcomes (PROs) and the intertransverse fusion rate in noninstrumented posterolateral fusion with either ABM/P-15 or allograft.
STUDY DESIGN


Double-blind randomized clinical trial.
PATIENT SAMPLE


Patients 60 years or older with degenerative spondylolisthesis undergoing decompression and noninstrumented posterolateral fusion.
OUTCOME MEASURES


Visual analog scales for back and leg pain, Oswestry Disability Index and EuroQoL-5D.
METHODS


One hundred one patients were enrolled in the study and randomized 1:1 to either ABM/P-15 (mixed 50/50, 5cc/level) or allograft bone (30 g/level), both mixed with local bone graft. PROs were collected at baseline and at 12 and 24 months after surgery. The patients underwent 1-year postoperative fine cut computed tomography-scans (0.9 mm) with reconstructions, independently evaluated by three reviewers. Fusion status was concluded by consensus of two of the three as ""fusion"" or ""no fusion.""
RESULTS


There were 49 patients available for analysis in both cohorts. The two groups were similar in terms of sex distribution, age, and number of levels fused. The fusion rate was significantly higher in the ABM/P-15 group with 50% fused compared with 20% in the allograft group. PROs at baseline and at all follow-up time points were similar between the two groups.
CONCLUSIONS


Patients undergoing noninstrumented posterolateral fusion augmented with ABM/P-15 had a statistically significantly higher fusion rate compared with allograft when evaluated with postoperative fine cut computed tomography-scans (0.9 mm) with reconstructions. However, this did not translate to better clinical outcomes.",2020,The fusion rate was significantly higher in the ABM/P-15 group with 50% fused compared with 20% in the allograft group.,"['49 patients available for analysis in both cohorts', 'One hundred one patients', 'Patients 60 years or older with degenerative spondylolisthesis (DS) undergoing decompression and non-instrumented posterolateral fusion', 'SAMPLE', 'non-instrumented lumbar fusion surgery']","['ABM/P-15 (mixed 50/50, 5cc/level) or allograft bone (30g/level), both mixed with local bone graft', 'ABM/P-15 or allograft', 'ABM/P-15 versus allograft', '15 amino acid residue (ABM/P-15']","['PROs', 'fusion rate', 'Visual analog scales (VAS) for back (BP) and leg pain (LP), Oswestry Disability Index and EuroQoL-5D.\nMETHODS', 'intertransverse fusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0264184', 'cui_str': 'Degenerative spondylolisthesis (disorder)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}]","[{'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",101.0,0.271495,The fusion rate was significantly higher in the ABM/P-15 group with 50% fused compared with 20% in the allograft group.,"[{'ForeName': 'Michael Kjær', 'Initials': 'MK', 'LastName': 'Jacobsen', 'Affiliation': 'Center for Spine Surgery & Research, Region of Southern Denmark, Østre Hougvej 55, DK-5500, Middelfart, Denmark; Institute of Regional Health Research, University of Southern Denmark, Winsløwparken 19, 3, DK-5000, Odense C, Denmark.'}, {'ForeName': 'Andreas Killerich', 'Initials': 'AK', 'LastName': 'Andresen', 'Affiliation': 'Center for Spine Surgery & Research, Region of Southern Denmark, Østre Hougvej 55, DK-5500, Middelfart, Denmark; Institute of Regional Health Research, University of Southern Denmark, Winsløwparken 19, 3, DK-5000, Odense C, Denmark.'}, {'ForeName': 'Annette Bennedsgaard', 'Initials': 'AB', 'LastName': 'Jespersen', 'Affiliation': 'Center for Spine Surgery & Research, Region of Southern Denmark, Østre Hougvej 55, DK-5500, Middelfart, Denmark; Institute of Regional Health Research, University of Southern Denmark, Winsløwparken 19, 3, DK-5000, Odense C, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Støttrup', 'Affiliation': 'Center for Spine Surgery & Research, Region of Southern Denmark, Østre Hougvej 55, DK-5500, Middelfart, Denmark; Institute of Regional Health Research, University of Southern Denmark, Winsløwparken 19, 3, DK-5000, Odense C, Denmark.'}, {'ForeName': 'Leah Y', 'Initials': 'LY', 'LastName': 'Carreon', 'Affiliation': 'Center for Spine Surgery & Research, Region of Southern Denmark, Østre Hougvej 55, DK-5500, Middelfart, Denmark; Institute of Regional Health Research, University of Southern Denmark, Winsløwparken 19, 3, DK-5000, Odense C, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Overgaard', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Sdr. Boulevard 29, DK-5000 Odense C, Denmark; Department of Clinical Research, University of Southern Denmark, Winsløwparken 19, 3, DK-5000, Odense C, Denmark.'}, {'ForeName': 'Mikkel Ø', 'Initials': 'MØ', 'LastName': 'Andersen', 'Affiliation': 'Center for Spine Surgery & Research, Region of Southern Denmark, Østre Hougvej 55, DK-5500, Middelfart, Denmark; Institute of Regional Health Research, University of Southern Denmark, Winsløwparken 19, 3, DK-5000, Odense C, Denmark. Electronic address: Mikkel.Andersen2@rsyd.dk.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.01.009']
3414,32124032,Accuracy of tibial positioning in the frontal plane: a prospective study comparing conventional and innovative techniques in total knee arthroplasty.,"BACKGROUND


Coronal alignment of the tibial component determines functional outcome and survival in total knee arthroplasty (TKA). Innovative techniques for tibial instrumentation have been developed to improve accuracy and reduce the rate of outliers.
METHODS


In a prospective study, 300 patients were allocated to four different groups using a randomization process (two innovative and two conventional) techniques of tibial instrumentation (conventional: extramedullary, intramedullary; innovative: navigation and patient-specific instrumentation (PSI); n = 75 for each group). The aims were to reconstruct the medial proximal tibial angle (MPTA) to 90° and the mechanical tibio-femoral axis (mTFA) to 0°. Both angles were evaluated and compared between all groups three months after the surgery. Patients who presented with a postoperative mTFA > 3° were classified as outliers.
RESULTS


The navigation and intramedullary technique both demonstrated that they were significantly more precise in reconstructing a neutral mTFA and MPTA compared to the other two techniques. The odd's ratio (OR) for producing outliers was highest for the PSI method (PSI OR = 5.5, p < 0.05; extramedullary positioning OR = 3.7, p > 0.05; intramedullary positioning OR = 1.7, p > 0.05; navigation OR = 0.04, p < 0.05). We could only observe significant differences between pre- and postoperative MPTA in the navigation and intramedullary group. The MPTA showed a significant negative correlation with the mTFA in all groups preoperatively and in the extramedullary, intramedullary and PSI postoperatively.
CONCLUSION


The navigation and intramedullary instrumentation provided the precise positioning of the tibial component. Outliers were most common within the PSI and extramedullary technique. Optimal alignment is dependent on the technique of tibial instrumentation and tibial component positioning determines the accuracy in TKA since mTFA correlated with MPTA pre- and postoperatively.",2020,"The MPTA showed a significant negative correlation with the mTFA in all groups preoperatively and in the extramedullary, intramedullary and PSI postoperatively.
","['Patients who presented with a postoperative mTFA\u2009>\u20093° were classified as outliers', 'total knee arthroplasty (TKA', 'total knee arthroplasty', '300 patients']","['tibial positioning', 'randomization process (two innovative and two conventional) techniques of tibial instrumentation (conventional: extramedullary, intramedullary; innovative: navigation and patient-specific instrumentation (PSI', 'conventional and innovative techniques']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C2732619', 'cui_str': 'Intramedullary'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1706489', 'cui_str': 'Psi'}]",[],300.0,0.0211651,"The MPTA showed a significant negative correlation with the mTFA in all groups preoperatively and in the extramedullary, intramedullary and PSI postoperatively.
","[{'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Zahn', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Graef', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany. frank.graef@charite.de.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Conrad', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Renner', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Perka', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hommel', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Charitéplatz 1, 10115, Berlin, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03389-4']
3415,31219771,Sex differences in blood pressure regulation during ischemic isometric exercise: the role of the β-adrenergic receptors.,"We sought to investigate whether the β-adrenergic receptors play a pivotal role in sex-related differences in arterial blood pressure (BP) regulation during isometric exercise. Sixteen volunteers (8 women) performed 2 min of ischemic isometric handgrip exercise (IHE) and 2 min of postexercise circulatory occlusion (PECO). Heart rate (HR) and beat-to-beat arterial BP were continuously measured. Beat-to-beat estimates of stroke volume (ModelFlow) were obtained and matched with HR to calculate cardiac output (Q̇) and total peripheral resistance (TPR). Two trials were randomly conducted between placebo and nonselective β-adrenergic blockade (40 mg propranolol). Under the placebo condition, the magnitude of the BP response in IHE was lower in women compared with men. During PECO, the BP remained elevated and the sex differences persisted. The β-blockade attenuated the BP response during IHE in men (∆57 ± 4 vs. ∆45 ± 7 mmHg,  P  = 0.025) due to a reduction in Q̇ (∆3.7 ± 0.5 vs. ∆1.8 ± 0.2 L/min,  P  = 0.012) while TPR was not affected. In women, however, the BP response during IHE was unchanged (∆27 ± 3 vs. ∆28 ± 3 mmHg,  P  = 0.889), despite attenuated Q̇ (∆2.7 ± 0.4 vs. ∆1.3 ± 0.2 L/min,  P  = 0.012). These responses were mediated by a robust increase in TPR under β-blockade (∆-0.2 ± 0.4 vs. ∆2.2 ± 0.7 mmHg·L -1 ·min,  P  = 0.012). These findings demonstrate that the sex differences in arterial BP regulation during ischemic IHE are mediated by β-adrenergic receptors. NEW & NOTEWORTHY  We found that the blood pressure response during isometric exercise in women is mediated by increases in cardiac output, whereas in men it is mediated by increases in both cardiac output and total peripheral resistance. In addition, women showed a robust increase in total peripheral resistance under β-blockade during isometric exercise and muscle metaboreflex activation. These findings demonstrate that sex differences in blood pressure regulation during isometric exercise are mediated by β-adrenergic receptors.",2019,These responses were mediated by a robust increase in TPR under β-blockade,['Sixteen volunteers (8 women'],"['placebo and non-selective β-adrenergic blockade (40mg propranolol', 'ischemic isometric handgrip exercise (IHE) and 2 min of post exercise circulatory occlusion (PECO', 'l/min  vs  ∆', 'L-1.min']","['Blood Pressure Regulation', 'arterial blood pressure (BP) regulation', 'arterial BP regulation', 'cardiac output (Q̇) and total peripheral resistance (TPR', 'Heart rate (HR) and beat-to-beat arterial BP', 'BP response in IHE', 'BP response', 'BP response during IHE', 'TPR under β-blockade']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001637', 'cui_str': 'Adrenergic Drugs'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]",16.0,0.122915,These responses were mediated by a robust increase in TPR under β-blockade,"[{'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Samora', 'Affiliation': 'NeuroV̇ASQ̇-Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasília, Brasilia, Distrito Federal, Brazil.'}, {'ForeName': 'Anthony V', 'Initials': 'AV', 'LastName': 'Incognito', 'Affiliation': 'NeuroV̇ASQ̇-Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasília, Brasilia, Distrito Federal, Brazil.'}, {'ForeName': 'Lauro C', 'Initials': 'LC', 'LastName': 'Vianna', 'Affiliation': 'NeuroV̇ASQ̇-Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasília, Brasilia, Distrito Federal, Brazil.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00270.2019']
3416,31400513,Targeting pregnancy-related weight gain to reduce disparities in obesity: Baseline results from the Healthy Babies trial.,"BACKGROUND


Obesity affects African American women more than any other group in the US. Pregnancy represents a critical life stage of heightened vulnerability for new or persistent obesity, yet few interventions have been effective in reducing excessive gestational weight gain among African American women. We describe the design and baseline findings of Healthy Babies, a two-arm randomized controlled trial testing a mobile health intervention to minimize excessive gestational weight gain versus usual care in this high risk group.
METHODS


African American women in early pregnancy were recruited from two large obstetric practices as well as Philadelphia Women, Infants, and Children's clinics. Participants randomized to the intervention received behavior change goals, daily text messages with feedback, web-based weight gain graphs, health coaching, and a Facebook support group. Data collection included baseline (<22 weeks' gestation), 36-38 weeks' gestation, and 6-month postpartum anthropometric measures and assessments of demographics, contextual factors and behavioral targets. The primary outcome was prevalence of excessive gestational weight gain.
RESULTS


Among participants at baseline (n = 262), the majority met criteria for obesity (63%), were multiparous (62%), single (77%), and were on average 25.6 ± 5.4 years old with a gestational age of 13.9 ± 4.1 weeks. While 82% completed high school, 61% met criteria for inadequate health literacy. Nearly 20% were food insecure. Eighty-eight percent reported a gestational weight gain goal discordant with Institute of Medicine guidelines. There were no significant differences in baseline characteristics between study arms.
CONCLUSIONS


Participants represent a high-risk group for excessive gestational weight gain with demonstrated need for intervention.",2019,"There were no significant differences in baseline characteristics between study arms.
","['African American women', 'Healthy Babies trial', ""African American women in early pregnancy were recruited from two large obstetric practices as well as Philadelphia Women, Infants, and Children's clinics"", 'Healthy Babies', 'Eighty-eight percent reported a gestational weight gain goal discordant with Institute of Medicine guidelines', 'participants at baseline (n\u202f=\u202f262), the majority met criteria for obesity (63%), were multiparous (62%), single (77%), and were on average 25.6\u202f±\u202f5.4\u202fyears old with a gestational age of 13.9\u202f±\u202f4.1\u202fweeks']","['mobile health intervention to minimize excessive gestational weight gain versus usual care', 'behavior change goals, daily text messages with feedback, web-based weight gain graphs, health coaching, and a Facebook support group']","['6-month postpartum anthropometric measures and assessments of demographics, contextual factors and behavioral targets', 'excessive gestational weight gain', 'prevalence of excessive gestational weight gain']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0021621', 'cui_str': 'National Academies of Science, Engineering, and Medicine (US) Health and Medicine Division'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026751', 'cui_str': 'Multiparity'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.278138,"There were no significant differences in baseline characteristics between study arms.
","[{'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America; Department of Obstetrics, Gynecology, and Reproductive Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America; Department of Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America. Electronic address: herris01@temple.edu.'}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Albert', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Niesha', 'Initials': 'N', 'LastName': 'Darden', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Bailer', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Cruice', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Sarmina', 'Initials': 'S', 'LastName': 'Hassan', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Bennett', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, United States of America; Duke Digital Health Science Center, Duke Global Health Institute, Durham, NC, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Goetzl', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, University of Texas Health Center at Houston, Houston, TX, United States of America.'}, {'ForeName': 'Daohai', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Kilby', 'Affiliation': 'Philadelphia Women, Infants and Children Program, Philadelphia, PA, United States of America.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America; Weight Watchers International, New York, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105822']
3417,31313237,Impact of Exercise on Body Composition and Cardiometabolic Risk Factors in Patients Awaiting Bariatric Surgery.,"BACKGROUND


The role of exercise to achieve weight reductions in patients awaiting bariatric surgery has been little studied. The aim of this study was to describe the effects of an exercise program on body composition and cardiometabolic risk factors in patients awaiting bariatric surgery.
METHODS


Twenty-three patients awaiting bariatric surgery were divided into two groups: (a) an exercise group (EG, n = 12) and (b) a control group (CG, n = 11). Both groups received the usual care prior to surgery, but the EG also performed a 12-week exercise program which combined endurance and resistance training. Body composition, cardiometabolic risk factors, physical fitness, basal metabolic rate, and quality of life were assessed at baseline and at the end of the study.
RESULTS


After the exercise program, the EG achieved significant reductions in total weight (- 7.3 ± 4.1 kg, P < 0.01), fat mass (- 7.1 ± 4.7 kg, P < 0.01), and waist circumference (- 5.3 ± 2.1 cm, P < 0.01), while they maintained their fat-free mass and basal metabolic rate levels. Only the EG showed reductions in HbA1c (- 0.4 ± 0.45%, P < 0.05), systolic (- 10.5 ± 12.7 mmHg), and diastolic blood pressure (- 3.9 ± 5.2 mmHg, P < 0.05), as well as a decrease in waist-to-height ratio (- 0.032 ± 0.12, P < 0.01) and an improvement in quality of life.
CONCLUSIONS


The implementation of an exercise program prior to bariatric surgery reduces fat mass and central obesity and improves cardiometabolic risk factors and quality of life, especially in the physical scales.
TRIAL REGISTRATION


The study was registered at ClinicalTrials.gov (NCT03613766).",2019,"Only the EG showed reductions in HbA1c (- 0.4 ± 0.45%, P < 0.05), systolic (- 10.5 ± 12.7 mmHg), and diastolic blood pressure (- 3.9 ± 5.2 mmHg, P < 0.05), as well as a decrease in waist-to-height ratio (- 0.032 ± 0.12, P < 0.01) and an improvement in quality of life.
","['Twenty-three patients awaiting bariatric surgery', 'Patients Awaiting Bariatric Surgery', 'patients awaiting bariatric surgery']","['exercise program', 'Exercise', 'exercise program prior to bariatric surgery', 'usual care prior to surgery, but the EG also performed a 12-week exercise program which combined endurance and resistance training']","['waist-to-height ratio', 'Body composition, cardiometabolic risk factors, physical fitness, basal metabolic rate, and quality of life', 'fat mass and central obesity and improves cardiometabolic risk factors and quality of life', 'diastolic blood pressure', 'total weight', 'Body Composition and Cardiometabolic Risk Factors', 'quality of life', 'weight reductions', 'fat mass', 'systolic', 'waist circumference', 'body composition and cardiometabolic risk factors']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C1821269', 'cui_str': 'Height-Weight Ratio'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0678121', 'cui_str': 'Basal metabolic rate (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4551560', 'cui_str': 'Central obesity (disorder)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",23.0,0.0221704,"Only the EG showed reductions in HbA1c (- 0.4 ± 0.45%, P < 0.05), systolic (- 10.5 ± 12.7 mmHg), and diastolic blood pressure (- 3.9 ± 5.2 mmHg, P < 0.05), as well as a decrease in waist-to-height ratio (- 0.032 ± 0.12, P < 0.01) and an improvement in quality of life.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marc-Hernández', 'Affiliation': 'Laboratory of Training Analysis and Optimization, Sport Research Center, Miguel Hernandez University, Elche, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Center of Excellence for the Diagnosis and Treatment of Obesity and Diabetes, Valladolid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aracil', 'Affiliation': 'Department of Sport Sciences, Sport Research Center, Miguel Hernandez University, Elche, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Guillén', 'Affiliation': 'Laboratory of Training Analysis and Optimization, Sport Research Center, Miguel Hernandez University, Elche, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Moya-Ramón', 'Affiliation': 'Laboratory of Training Analysis and Optimization, Sport Research Center, Miguel Hernandez University, Elche, Spain. mmoya@umh.es.'}]",Obesity surgery,['10.1007/s11695-019-04088-9']
3418,31353257,Effect of mobile phone text messaging for improving the uptake of influenza vaccination in patients with rare diseases.,"OBJECTIVES


Influenza vaccine is recommended in some chronic medical conditions, including several rare diseases. The objectives of the study were to assess the effect of text message reminders on influenza vaccination uptake of patients with selected rare diseases and delayed vaccination, and to describe their characteristics.
METHODS


Quasi-experimental pre-post intervention study performed along the 2016 influenza vaccination campaign in the Autonomous Community of Madrid. Unvaccinated patients diagnosed with a selected rare disease were targeted for intervention. SMS were sent to them at least one month after the beginning of the campaign, in four consecutive weeks. Those with no mobile phones available or no certainty of message reception, were assigned as controls. The association between the reception of the SMS and vaccination uptake was assessed using multiple poisson regression models.
RESULTS


Of 69.040 patients with delayed vaccination, 87.2% received an SMS reminder in the asigned contact mobile telephone. Global influenza vaccine coverage reached 41.3%. The uptake of influenza vaccine was significantly higher among those receiving the reminder (9.3% vs. 7.1% in the control group, p < 0.001). Those who received a SMS reminder were 30% more likely to uptake seasonal influenza vaccine. By sex and age, the reception of the reminder was associated with a significantly higher probability of vaccination in men ≥65 years with at least a concurrent chronic condition (IRR: 1.58, CI95%: 1.25-2.00). Among women, this higher probability was detected in those between 14 and 64 years of age (IRR: 1.41, CI95%: 1.22-1.63), and ≥65 years without concurrent chronic conditions (IRR: 1.40, CI95%: 1.05-1.89).
CONCLUSION


Although the intervention was modestly effective, it proved beneficial in some cases. It can be an additional strategy to improve vaccine uptake, since it is simple, feasible, affordable and easily scalable, particularly when immunization and target population data are available in population registries.",2019,"The uptake of influenza vaccine was significantly higher among those receiving the reminder (9.3% vs. 7.1% in the control group, p < 0.001).","['Unvaccinated patients diagnosed with a selected rare disease', '69.040 patients with delayed vaccination, 87.2% received an SMS reminder in the asigned contact mobile telephone', 'Quasi-experimental pre-post intervention study performed along the 2016 influenza vaccination campaign in the Autonomous Community of Madrid', 'patients with rare diseases', 'patients with selected rare diseases and delayed vaccination, and to describe their characteristics']","['mobile phone text messaging', 'text message reminders']","['SMS and vaccination uptake', 'uptake seasonal influenza vaccine', 'uptake of influenza vaccination', 'Global influenza vaccine coverage', 'influenza vaccination uptake', 'uptake of influenza vaccine']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678236', 'cui_str': 'Rare Diseases'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.0428424,"The uptake of influenza vaccine was significantly higher among those receiving the reminder (9.3% vs. 7.1% in the control group, p < 0.001).","[{'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Esteban-Vasallo', 'Affiliation': 'Servicio de Informes de Salud y Estudios, Subdirección General de Epidemiología, Dirección General de Salud Pública, Autonomous Community of Madrid, Spain. Electronic address: maria.estebanv@salud.madrid.org.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Domínguez-Berjón', 'Affiliation': 'Servicio de Informes de Salud y Estudios, Subdirección General de Epidemiología, Dirección General de Salud Pública, Autonomous Community of Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'García-Riolobos', 'Affiliation': 'Servicio de Informes de Salud y Estudios, Subdirección General de Epidemiología, Dirección General de Salud Pública, Autonomous Community of Madrid, Spain.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Zoni', 'Affiliation': 'Servicio de Informes de Salud y Estudios, Subdirección General de Epidemiología, Dirección General de Salud Pública, Autonomous Community of Madrid, Spain.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Aréjula Torres', 'Affiliation': 'Dirección Técnica de Sistemas de Información, Gerencia Adjunta de Atención Primaria, Autonomous Community of Madrid, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sánchez-Perruca', 'Affiliation': 'Dirección Técnica de Sistemas de Información, Gerencia Adjunta de Atención Primaria, Autonomous Community of Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Astray-Mochales', 'Affiliation': 'Servicio de Epidemiología, Subdirección General de Epidemiología, Dirección General de Salud Pública, Autonomous Community of Madrid, Spain.'}]",Vaccine,['10.1016/j.vaccine.2019.07.062']
3419,32109194,Randomized Phase II Study of First-Line Cladribine With Concurrent or Delayed Rituximab in Patients With Hairy Cell Leukemia.,"PURPOSE


Single-agent purine analog, usually cladribine, has been the standard first-line therapy of hairy cell leukemia (HCL) for 30 years. High complete remission (CR) rates often include minimal residual disease (MRD), leading to relapse and repeated treatments. Rituximab can clear MRD, but long-term results are unknown and optimal timing of rituximab undefined.
PATIENTS AND METHODS


Patients were randomly assigned to first-line cladribine 0.15 mg/kg intravenously days 1-5 with 8 weekly doses of rituximab 375 mg/m 2  begun either day 1 (concurrent, CDAR) or ≥ 6 months later (delayed) after detection of MRD in blood. MRD tests included blood and bone marrow (BM) flow cytometry, and BM immunohistochemistry.
RESULTS


Sixty-eight patients with purine analog-naïve classic HCL were randomly assigned 1:1 to concurrent versus delayed arms. At 6 months after CDAR versus cladribine monotherapy, CR rates were 100% versus 88% ( P  = .11), MRD-free CR rates 97% versus 24% ( P  < .0001, primary end point), and blood MRD-free rates 100% versus 50% ( P  < .0001), respectively. At 96 months median follow-up, 94% versus 12% remained MRD free. Compared with CDAR, delayed rituximab after cladribine achieved lower rate (67% of 21 evaluable patients;  P  = .0034) and durability ( P  = .0081, hazard radio favoring CDAR, 0.094) of MRD-free CR. Nevertheless, 12 patients in the delayed arm remained MRD free when restaged 6-104 (median, 78) months after last delayed rituximab treatment. Compared with cladribine monotherapy, CDAR led to brief grade 3/4 thrombocytopenia (59%  v  9%;  P  < .0001) and platelet transfusions without bleeding (35%  v  0%;  P  = .0002), but higher neutrophil ( P  = .017) and platelet ( P  = .0015) counts at 4 weeks.
CONCLUSION


Achieving MRD-free CR of HCL after first-line cladribine is greatly enhanced by concurrent rituximab and less so by delayed rituximab. Longer follow-up will determine if MRD-free survival leads to less need for additional therapy or cure of HCL.",2020,Longer follow-up will determine if MRD-free survival leads to less need for additional therapy or cure of HCL.,"['hairy cell leukemia (HCL) for 30 years', 'Patients', 'Patients With Hairy Cell Leukemia', 'Sixty-eight patients with purine analog-naïve classic HCL']","['cladribine monotherapy', 'Rituximab', 'rituximab 375 mg/m 2  begun either day 1 (concurrent, CDAR', 'First-Line Cladribine With Concurrent or Delayed Rituximab', 'cladribine']","['platelet transfusions without bleeding', 'CR rates', 'MRD free', 'CDAR led to brief grade 3/4 thrombocytopenia', 'MRD-free CR rates', 'lower rate', 'durability', 'higher neutrophil', 'High complete remission (CR) rates', 'blood and bone marrow (BM) flow cytometry, and BM immunohistochemistry', 'blood MRD-free rates']","[{'cui': 'C0023443', 'cui_str': 'Reticuloendotheliosis, Leukemic'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C1268902', 'cui_str': 'Purine analog'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0443985', 'cui_str': 'Flinders medical center-7 marker (substance)'}]","[{'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0016263', 'cui_str': 'Flow Microfluorimetry'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}]",68.0,0.0305729,Longer follow-up will determine if MRD-free survival leads to less need for additional therapy or cure of HCL.,"[{'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Chihara', 'Affiliation': 'Medical Oncology Service, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Arons', 'Affiliation': 'Laboratory of Molecular Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Maryalice', 'Initials': 'M', 'LastName': 'Stetler-Stevenson', 'Affiliation': 'Laboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Constance M', 'Initials': 'CM', 'LastName': 'Yuan', 'Affiliation': 'Laboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Hao-Wei', 'Initials': 'HW', 'LastName': 'Wang', 'Affiliation': 'Laboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Laboratory of Molecular Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Raffeld', 'Affiliation': 'Laboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Liqiang', 'Initials': 'L', 'LastName': 'Xi', 'Affiliation': 'Laboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Steinberg', 'Affiliation': 'Biostatistics and Data Management Section, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Feurtado', 'Affiliation': 'Office of Research Nursing, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'James', 'Affiliation': 'Laboratory of Molecular Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Wyndham', 'Initials': 'W', 'LastName': 'Wilson', 'Affiliation': 'Lymphoid Malignancies Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Raul C', 'Initials': 'RC', 'LastName': 'Braylan', 'Affiliation': 'Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Calvo', 'Affiliation': 'Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Maric', 'Affiliation': 'Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Dulau-Florea', 'Affiliation': 'Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Kreitman', 'Affiliation': 'Medical Oncology Service, National Cancer Institute, National Institutes of Health, Bethesda, MD.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02250']
3420,30508156,REVERCE: a randomized phase II study of regorafenib followed by cetuximab versus the reverse sequence for previously treated metastatic colorectal cancer patients.,"BACKGROUND


The objective of this randomized phase II trial was to evaluate efficacy and safety of the therapeutic sequence of regorafenib followed by cetuximab, compared with cetuximab followed by regorafenib, as the current standard sequence for metastatic colorectal cancer patients.
PATIENTS AND METHODS


Patients with KRAS exon 2 wild-type metastatic colorectal cancer after failure of fluoropyrimidine, oxaliplatin, and irinotecan were randomized to receive sequential treatment with regorafenib followed by cetuximab ± irinotecan (R-C arm), or the reverse sequence [cetuximab ± irinotecan followed by regorafenib (C-R arm)]. The primary end point was overall survival (OS). Key secondary end points included progression-free survival (PFS) with initial treatment (PFS1), PFS with second treatment (PFS2), safety, and quality of life. Exploratory end points included serial biomarker analyses, including oncogenic alterations from circulating tumor DNA or multiple serum or plasma proteins.
RESULTS


One-hundred one patients were randomized and eligible for efficacy analysis. Sequential treatment was successful in 86% patients in both arms. Median OS for R-C and C-R was 17.4 and 11.6 months, respectively (P = 0.0293), with a hazard ratio (HR) of 0.61 for OS [95% confidence interval (CI) 0.39-0.96]. The HR for PFS1 (regorafenib in R-C versus cetuximab in C-R) was 0.97 (95% CI 0.61-1.54), and PFS2 (C in R-C versus R in C-R) was 0.29 (95% CI 0.17-0.50). No unexpected safety signals were observed. The quality of life scores during the entire treatment period was not significantly different between the two arms. Circulating biomarker analyses showed emerging oncogenic alterations in RAS, BRAF, EGFR, HER2, and MET, which were more commonly detected after cetuximab than after regorafenib.
CONCLUSIONS


The therapeutic sequence of regorafenib followed by cetuximab suggests a longer OS than the current standard sequence.",2019,The quality of life scores during the entire treatment period was not significantly different between the two arms.,"['previously treated metastatic colorectal cancer patients', 'One-hundred one patients', 'Patients with KRAS exon 2 wild-type metastatic colorectal cancer after failure of', 'metastatic colorectal cancer patients']","['regorafenib followed by cetuximab', 'regorafenib', 'cetuximab followed by regorafenib', 'regorafenib followed by cetuximab ± irinotecan (R-C arm), or the reverse sequence [cetuximab ± irinotecan', 'fluoropyrimidine, oxaliplatin, and irinotecan', 'cetuximab']","['HR for PFS1 (regorafenib', 'progression-free survival (PFS) with initial treatment (PFS1), PFS with second treatment (PFS2), safety, and quality of life', 'quality of life scores', 'overall survival (OS', 'serial biomarker analyses, including oncogenic alterations from circulating tumor DNA or multiple serum or plasma proteins', 'efficacy and safety', 'Median OS for R-C and C-R']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032120', 'cui_str': 'Plasma Proteins'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",101.0,0.0701014,The quality of life scores during the entire treatment period was not significantly different between the two arms.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Denda', 'Affiliation': 'Division of Gastroenterology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, Tonan Hospital, Sapporo, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Komatsu', 'Affiliation': 'Division of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Medical Oncology, Kushiro Rosai Hospital, Kushiro, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Okuda', 'Affiliation': 'Department of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Asayama', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Akiyoshi', 'Affiliation': 'Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kagawa', 'Affiliation': 'Department of Surgery, Kansai Rosa Hospital, Amagasaki, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Oki', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ando', 'Affiliation': 'School of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hagiwara', 'Affiliation': 'Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Department of Integrated Science and Engineering for Sustainable Society, Faculty of Science and Engineering, Chuo University, Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. Electronic address: tyoshino@east.ncc.go.jp.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdy526']
3421,32125709,Design of the SILICOFCM study: Effect of sacubitril/valsartan vs lifestyle intervention on functional capacity in patients with hypertrophic cardiomyopathy.,"BACKGROUND


Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiovascular disease with a broad spectrum of disease severity. HCM ranges from a benign course to a progressive disorder characterized by angina, heart failure, malignant arrhythmia, syncope, or sudden cardiac death. So far, no medical treatment has reliably shown to halt or reverse progression of HCM or to alleviate its symptoms. While the angiotensin receptor neprilysin inhibitor sacubitril/valsartan has shown to reduce mortality and hospitalization in heart failure with reduced ejection fraction, data on its effect on HCM are sparse.
HYPOTHESIS


A 4-month pharmacological (sacubitril/valsartan) or lifestyle intervention will significantly improve exercise tolerance (ie, peak oxygen consumption) in patients with nonobstructive HCM compared to the optimal standard therapy (control group).
METHODS


SILICOFCM is a prospective, multicenter, open-label, randomized, controlled, three-arm clinical trial (NCT03832660) that will recruit 240 adult patients with a confirmed diagnosis of nonobstructive HCM. Eligible patients are randomized to sacubitril/valsartan, lifestyle intervention (physical activity and dietary supplementation with inorganic nitrate), or optimal standard therapy alone (control group). The primary endpoint is the change in functional capacity (ie, peak oxygen consumption). Secondary endpoints include: (a) Change in cardiac structure and function as assessed by transthoracic echocardiography and cardiac magnetic resonance (MRI imaging), (b) change in biomarkers (ie, CK, CKMB, and NT-proBNP), (c) physical activity, and (d) quality of life.
RESULTS


Until December 2019, a total of 41 patients were recruited into the ongoing SILICOFCM study and were allocated to the study groups and the control group. There was no significant difference in key baseline characteristics between the three groups.
CONCLUSION


The SILICOFCM study will provide novel evidence about the effect of sacubitril/valsartan or lifestyle intervention on functional capacity, clinical phenotype, injury and stretch activation markers, physical activity, and quality of life in patients with nonobstructive HCM.",2020,"So far, no medical treatment has reliably shown to halt or reverse progression of HCM or to alleviate its symptoms.","['patients with hypertrophic cardiomyopathy', 'patients with nonobstructive HCM', '41 patients were recruited into the ongoing SILICOFCM study', '240 adult patients with a confirmed diagnosis of nonobstructive HCM', 'Until December 2019', 'Eligible patients', 'patients with nonobstructive HCM compared to the optimal standard therapy (control group']","['pharmacological (sacubitril/valsartan) or lifestyle intervention', 'sacubitril/valsartan vs lifestyle intervention', 'sacubitril/valsartan, lifestyle intervention (physical activity and dietary supplementation with inorganic nitrate), or optimal standard therapy alone (control group', 'sacubitril/valsartan or lifestyle intervention']","['exercise tolerance (ie, peak oxygen consumption', 'change in functional capacity (ie, peak oxygen consumption', 'functional capacity, clinical phenotype, injury and stretch activation markers, physical activity, and quality of life', ' (a) Change in cardiac structure and function as assessed by transthoracic echocardiography and cardiac magnetic resonance (MRI imaging), (b) change in biomarkers (ie, CK, CKMB, and NT-proBNP), (c) physical activity, and (d) quality of life', 'functional capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic Cardiomyopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography (procedure)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}]",240.0,0.0563467,"So far, no medical treatment has reliably shown to halt or reverse progression of HCM or to alleviate its symptoms.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tafelmeier', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baessler', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Unsoeld', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Preveden', 'Affiliation': 'Medical Faculty, University of Novi Sad, Novi Sad, Serbia and Institute of cardiovascular diseases of Vojvodina, Sremska Kamenica, Serbia.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Barlocco', 'Affiliation': 'Careggi University Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Tomberli', 'Affiliation': 'Careggi University Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Dejana', 'Initials': 'D', 'LastName': 'Popovic', 'Affiliation': 'Cardiology Department, Clinical Centre of Serbia, Faculties of Medicine and Pharmacy, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brennan', 'Affiliation': 'Cardiovascular Research, Clinical and Translational Research Institute, Newcastle University and Newcastle upon Tyne Hospitals NHF Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Guy A', 'Initials': 'GA', 'LastName': 'MacGowan', 'Affiliation': 'Cardiovascular Research, Clinical and Translational Research Institute, Newcastle University and Newcastle upon Tyne Hospitals NHF Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Arsen', 'Initials': 'A', 'LastName': 'Ristic', 'Affiliation': 'Cardiology Department, Clinical Centre of Serbia, Faculties of Medicine and Pharmacy, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Lazar', 'Initials': 'L', 'LastName': 'Velicki', 'Affiliation': 'Medical Faculty, University of Novi Sad, Novi Sad, Serbia and Institute of cardiovascular diseases of Vojvodina, Sremska Kamenica, Serbia.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Olivotto', 'Affiliation': 'Careggi University Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Djordje G', 'Initials': 'DG', 'LastName': 'Jakovljevic', 'Affiliation': 'Cardiovascular Research, Clinical and Translational Research Institute, Newcastle University and Newcastle upon Tyne Hospitals NHF Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Maier', 'Affiliation': 'Department of Internal Medicine II (Cardiology, Pneumology, and Intensive Care), University Medical Centre Regensburg, Regensburg, Germany.'}]",Clinical cardiology,['10.1002/clc.23346']
3422,32066146,Adverse Effects of Low-Dose Methotrexate: A Randomized Trial.,"Background


Low-dose methotrexate (LD-MTX) is the most commonly used drug for systemic rheumatic diseases worldwide and is the recommended first-line agent for rheumatoid arthritis. Despite extensive clinical use for more than 30 years, few data on adverse event (AE) rates derive from randomized, placebo-controlled trials, where both causality and magnitude of risk can be inferred.
Objective


To investigate AE rates, risk, and risk differences comparing LD-MTX versus placebo.
Design


Prespecified secondary analyses of a double-blind, placebo-controlled, randomized trial. (ClinicalTrials.gov: NCT01594333).
Setting


North America.
Participants


Adults with known cardiovascular disease and diabetes or metabolic syndrome.
Intervention


Random allocation to LD-MTX (≤20 mg/wk) or placebo. All participants received folic acid, 1 mg/d, 6 days per week.
Measurements


Risks for specific AEs of interest, as well as for all AEs, were compared across treatment groups after blinded adjudication.
Results


After an active run-in period, 6158 patients were enrolled and 4786 randomly assigned to a group; median follow-up was 23 months and median dosage 15 mg/wk. Among the randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2. Of 2391 participants assigned to LD-MTX, 2080 (87.0%) had an AE of interest, compared with 1951 of 2395 (81.5%) assigned to placebo (hazard ratio [HR], 1.17 [95% CI, 1.10 to 1.25]). The relative hazards of gastrointestinal (HR, 1.91 [CI, 1.75 to 2.10]), pulmonary (HR, 1.52 [CI, 1.16 to 1.98]), infectious (HR, 1.15 [CI, 1.01 to 1.30]), and hematologic (HR, 1.15 [CI, 1.07 to 1.23]) AEs were elevated for LD-MTX versus placebo. With the exception of increased risk for skin cancer (HR, 2.05 [CI, 1.28 to 3.28]), the treatment groups did not differ in risk for other cancer or mucocutaneous, neuropsychiatric, or musculoskeletal AEs. Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
Limitation


The trial was done in patients without rheumatic disease who tolerated LD-MTX during an active run-in period.
Conclusion


Use of LD-MTX was associated with small to moderate elevations in risks for skin cancer and gastrointestinal, infectious, pulmonary, and hematologic AEs, whereas renal AEs were decreased.
Primary Funding Source


National Institutes of Health.",2020,"Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
","['6158 patients', 'patients without rheumatic disease who tolerated LD-MTX during an active run-in period', 'randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2', '2391 participants assigned to', 'Participants\n\n\nAdults with known cardiovascular disease and diabetes or metabolic syndrome']","['placebo', '\n\n\nLow-dose methotrexate (LD-MTX', 'LD-MTX', 'Low-Dose Methotrexate', 'LD-MTX versus placebo', 'folic acid']","['increased risk for skin cancer', 'Renal AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035435', 'cui_str': 'Rheumatism'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}]",6158.0,0.678699,"Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
","[{'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Karlson', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Fengxin', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Corrigan', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Colls', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'MacFadyen', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Barbhaiya', 'Affiliation': 'Hospital for Special Surgery, New York, New York (M.B.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Berliner', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Dellaripa', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Brendan M', 'Initials': 'BM', 'LastName': 'Everett', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Aruna D', 'Initials': 'AD', 'LastName': 'Pradhan', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Hammond', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Deepak A', 'Initials': 'DA', 'LastName': 'Rao', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Susan Y', 'Initials': 'SY', 'LastName': 'Ritter', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rutherford', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sparks', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Stratton', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Dong H', 'Initials': 'DH', 'LastName': 'Suh', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Tedeschi', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Kathleen M M', 'Initials': 'KMM', 'LastName': 'Vanni', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Nina P', 'Initials': 'NP', 'LastName': 'Paynter', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}]",Annals of internal medicine,['10.7326/M19-3369']
3423,31682462,Echocardiographic Changes with Positive Airway Pressure Therapy in Obesity Hypoventilation Syndrome. Long-Term Pickwick Randomized Controlled Clinical Trial.,"Rationale:  Obesity hypoventilation syndrome (OHS) has been associated with cardiac dysfunction. However, randomized trials assessing the impact of long-term noninvasive ventilation (NIV) or continuous positive airway pressure (CPAP) on cardiac structure and function assessed by echocardiography are lacking. Objectives:  In a prespecified secondary analysis of the largest multicenter randomized controlled trial of OHS (Pickwick Project;  N  = 221 patients with OHS and coexistent severe obstructive sleep apnea), we compared the effectiveness of three years of NIV and CPAP on structural and functional echocardiographic changes. Methods:  At baseline and annually during three sequential years, patients underwent transthoracic two-dimensional and Doppler echocardiography. Echocardiographers at each site were blinded to the treatment allocation. Statistical analysis was performed using a linear mixed-effects model with a treatment group and repeated measures interaction to determine the differential effect between CPAP and NIV. Measurements and Main Results:  A total of 196 patients were analyzed: 102 were treated with CPAP and 94 were treated with NIV. Systolic pulmonary artery pressure decreased from 40.5 ± 1.47 mm Hg at baseline to 35.3 ± 1.33 mm Hg at three years with CPAP, and from 41.5 ± 1.56 mm Hg to 35.5 ± 1.42 with NIV ( P  < 0.0001 for longitudinal intragroup changes for both treatment arms). However, there were no significant differences between groups. NIV and CPAP therapies similarly improved left ventricular diastolic dysfunction and reduced left atrial diameter. Both NIV and CPAP improved respiratory function and dyspnea. Conclusions:  In patients with OHS who have concomitant severe obstructive sleep apnea, long-term treatment with NIV and CPAP led to similar degrees of improvement in pulmonary hypertension and left ventricular diastolic dysfunction.Clinical trial registered with www.clinicaltrials.gov (NCT01405976).",2020,Systolic pulmonary artery pressure decreased from 40.5±1.47 mmHg at baseline to 35.3±1.33 mmHg at 3 years with CPAP and from 41.5±1.56 mmHg to 35.5±1.42 with NIV (p<0.0001 for longitudinal intragroup changes for both treatment arms).,"['196 patients were analysed, 102 treated with CPAP and 94 treated with NIV', 'patients with OHS who have concomitant severe obstructive sleep apnea, long-term treatment with NIV and', 'n=221 patient with OHS and coexistent severe obstructive sleep apnea', 'Obesity Hypoventilation Syndrome']","['Positive Airway Pressure Therapy', 'long-term noninvasive ventilation (NIV) or CPAP', 'NIV and CPAP', 'CPAP']","['left ventricular diastolic dysfunction and reduced left atrial diameter', 'Systolic pulmonary artery pressure', 'pulmonary hypertension and left ventricular diastolic dysfunction', 'respiratory function and dyspnea']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031880', 'cui_str': 'Obesity Hypoventilation Syndrome'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C1273070', 'cui_str': 'Left ventricular diastolic dysfunction'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}]",196.0,0.241593,Systolic pulmonary artery pressure decreased from 40.5±1.47 mmHg at baseline to 35.3±1.33 mmHg at 3 years with CPAP and from 41.5±1.56 mmHg to 35.5±1.42 with NIV (p<0.0001 for longitudinal intragroup changes for both treatment arms).,"[{'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Masa', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Mokhlesi', 'Affiliation': 'Medicine/Pulmonary and Critical Care, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Benítez', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Mogollon', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Gomez de Terreros', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain.'}, {'ForeName': 'Maria Ángeles', 'Initials': 'MÁ', 'LastName': 'Sánchez-Quiroga', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Auxiliadora', 'Initials': 'A', 'LastName': 'Romero', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Candela', 'Initials': 'C', 'LastName': 'Caballero-Eraso', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Maria Luz', 'Initials': 'ML', 'LastName': 'Alonso-Álvarez', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Ordax-Carbajo', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gomez-Garcia', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'González', 'Affiliation': 'Respiratory Department, Valdecilla Hospital, Santander, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'López-Martín', 'Affiliation': 'Respiratory Department, Gregorio Marañon Hospital, Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Marin', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Martí', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Díaz-Cambriles', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Eusebi', 'Initials': 'E', 'LastName': 'Chiner', 'Affiliation': 'Respiratory Department, San Juan Hospital, Alicante, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Egea', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Barca', 'Affiliation': 'Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Badajoz, Spain.'}, {'ForeName': 'Francisco-José', 'Initials': 'FJ', 'LastName': 'Vázquez-Polo', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Negrín', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martel-Escobar', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Barbe', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Corral', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201906-1122OC']
3424,32037213,The James A. Rand Young Investigator's Award: Traditional Intravenous Fluid vs. Oral Fluid Administration in Primary Total Knee Arthroplasty: A Randomized Trial.,"BACKGROUND


Optimal perioperative fluid management has not been established in patients undergoing orthopedic surgical procedures. Our purpose was to investigate the effects of perioperative fluid management (ie, preoperative, intraoperative, and postoperative) on patients undergoing total knee arthroplasty (TKA).
METHODS


One hundred thirty patients who met inclusion criteria undergoing primary unilateral TKA were prospectively randomized into traditional (TFG) vs oral (OFG) perioperative fluid management groups. The primary outcome was change in body weight (BW). Secondary outcome measures included knee motion, leg girth, bioelectrical impendence, quadriceps activation, functional outcomes testing, Knee injury and Osteoarthritis Outcome Score JR, VR-12, laboratory values, vital signs, patient satisfaction, pain scores, and adverse events.
RESULTS


The TFG had increased BW the evening of surgery (7.0 ± 4.3 vs 3.0 ± 3.9, P < .0001), postoperative day (POD) #1 (9.1 ± 4.3 vs 4.7 ± 3.9, P < .0001), and POD #2 (6.2 ± 5.0 vs 4.4 ± 4.0, P = .032). Bioelectrical impedance showed less limb edema in the OFG (4.2 ± 29.7 vs 17.8 ± 30.3, P < .0001) on POD #1. Urine specific gravity differences were seen preoperatively between groups (OFG, more hydrated, P = .002). Systolic blood pressure decrease from the baseline was greater in the OFG on arrival to the floor (19.4 ± 13.5 vs 10.6 ± 12.8, P < .0001) and 8 (23.4 ± 13.3 vs 17.0 ± 12.9, P = .006) and 16 (25.8 ± 13.8 vs 25.8 ± 13.8, P = .046) hours after floor arrival. The TFG had more urine output on POD #1 (3369 mL ± 1343 mL vs 2435 mL ± 1151 mL, P < .0001). The OFG were more likely to go home on POD #1 than the TFG (63 vs 56, P = .02).
CONCLUSION


Oral fluid intake with IVF restriction in the perioperative period after TKA may offer short-term benefits with swelling and BW fluctuations. The authors continue to limit perioperative IVFs and encourage patient initiated fluid intake.",2020,"Urine specific gravity differences were seen preoperatively between groups (OFG, more hydrated, P = .002).","['patients undergoing total knee arthroplasty (TKA', 'One hundred thirty patients who met inclusion criteria undergoing primary unilateral TKA', 'patients undergoing orthopedic surgical procedures', 'Primary Total Knee Arthroplasty']","['traditional (TFG) vs oral (OFG) perioperative fluid management groups', 'Traditional Intravenous Fluid Versus Oral Fluid Administration', 'TFG', 'perioperative fluid management (ie, preoperative, intraoperative, and postoperative']","['knee motion, leg girth, bioelectrical impendence, quadriceps activation, functional outcomes testing, Knee injury and Osteoarthritis Outcome Score JR, VR-12, laboratory values, vital signs, patient satisfaction, pain scores, and adverse events', 'Systolic blood pressure decrease', 'limb edema', 'Urine specific gravity differences', 'postoperative day (POD', 'change in body weight (BW']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1136201', 'cui_str': 'Orthopedic Surgical Procedures'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0553741', 'cui_str': 'Hydration control'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0518766'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0587361', 'cui_str': 'Specific gravity of urine (finding)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",130.0,0.196637,"Urine specific gravity differences were seen preoperatively between groups (OFG, more hydrated, P = .002).","[{'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Jennings', 'Affiliation': 'Colorado Joint Replacement, Porter Adventist Hospital, Denver, CO; Department of Mechanical and Materials Engineering, University of Denver, Denver, CO.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Mejia', 'Affiliation': 'US Anesthesia Partners, Denver, CO.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Williams', 'Affiliation': 'Porter Adventist Hospital, Denver, CO.'}, {'ForeName': 'Roseann M', 'Initials': 'RM', 'LastName': 'Johnson', 'Affiliation': 'Colorado Joint Replacement, Porter Adventist Hospital, Denver, CO.'}, {'ForeName': 'Charlie C', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Colorado Joint Replacement, Porter Adventist Hospital, Denver, CO.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Dennis', 'Affiliation': 'Colorado Joint Replacement, Porter Adventist Hospital, Denver, CO; Department of Mechanical and Materials Engineering, University of Denver, Denver, CO; Department of Orthopaedics, University of Colorado School of Medicine, Denver, CO; Department of Biomedical Engineering, University of Tennessee, Knoxville, TN.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.01.029']
3425,31373615,Incidence and mortality of nasopharyngeal carcinoma: interim analysis of a cluster randomized controlled screening trial (PRO-NPC-001) in southern China.,"BACKGROUND


Previous mass screening studies have shown that IgA antibodies against Epstein-Barr Virus (EBV) can facilitate early detection of nasopharyngeal carcinoma (NPC), but the impact of EBV-antibody screening for NPC-specific mortality remains unknown.
PATIENTS AND METHODS


A prospective, cluster randomized, controlled trial for NPC screening (PRO-NPC-001) was conducted in 3 selected towns of Zhongshan City and 13 selected towns of Sihui City in southern China beginning in 2008. Serum samples of the screening group were tested for two previously selected anti-EBV antibodies. Subjects with serological medium risk were subsequently retested annually for 3 years, and those with serological high risk were referred to otorhinolaryngologists for diagnostic check-up. An interim analysis was carried out to evaluate the primary end points of the NPC-specific mortality and the early diagnostic rate, and the secondary end point of the NPC incidence, through linkage with the database of Zhongshan City.
RESULTS


Among 70 296 total subjects, 29 413 screened participants (41.8% of the total subjects) in the screening group and 50 636 in the control group, 153 (43.3 per 100 000 person-year), 62 (55.3 per 100 000 person-year) and 99 (33.1 per 100 000 person-year) NPC cases were identified. The early diagnostic rates of NPC were significantly higher in the participants (79.0%, P < 0.0001) and the screening group (45.9%, P < 0.0001) compared with the control group (20.6%). Although no differences were found between NPC-specific mortality of the screening group and the control group [relative risk (RR)= 0.82, 95% confidence interval (CI) 0.37-1.79], lower NPC-specific mortality was noticed among participants from the screening group versus the control group (RR = 0.22, 95% CI 0.09-0.49).
CONCLUSION


IgA antibodies against EBV can identify high-risk population and was effective in screening for early asymptomatic NPC. Although the mortality reduction was not significant in the primary end point, we noted encouraging evidence of a mortality reduction in screening participants in this interim analysis.
CLINICAL TRIAL NUMBER


NCT00941538.",2019,"The early diagnositic rates of NPC were significantly higher in the participants (79.0%, P < 0.0001) and the screening group (45.9%, P < 0.0001) compared with the control group (20.6%).","['southern China', '3 selected towns of Zhongshan City and 13 selected towns of Sihui City in southern China beginning in 2008', '70,296 total subjects, 29,413 screened participants (41.8% of the total subjects) in the screening group and 50,636 in the control group, 153 (43.3 per 100,000 person-year), 62 (55.3 per 100,000 person-year) and 99 (33.1 per 100,000 person-year) NPC cases were identified', 'Subjects with serological medium risk were subsequently retested annually for three years, and those with serological high risk were referred to otorhinolaryngologists for diagnostic check-up']",['NPC screening (PRO-NPC-001'],"['Incidence and mortality of nasopharyngeal carcinoma', 'NPC-specific mortality', 'lower NPC-specific mortality', 'NPC-specific mortality and the early disgnositic rate', 'early diagnositic rates of NPC', 'mortality reduction']","[{'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205473', 'cui_str': 'Serologic (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0334893', 'cui_str': 'Otorhinolaryngologist (occupation)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.198412,"The early diagnositic rates of NPC were significantly higher in the participants (79.0%, P < 0.0001) and the screening group (45.9%, P < 0.0001) compared with the control group (20.6%).","[{'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Ji', 'Affiliation': ""Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Sheng', 'Affiliation': ""State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biological Products, School of Public Health, Xiamen University, Xiamen, People's Republic of China.""}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Cheng', 'Affiliation': ""Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China.""}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Ng', 'Affiliation': ""State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biological Products, School of Public Health, Xiamen University, Xiamen, People's Republic of China.""}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Wu', 'Affiliation': ""Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China.""}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Wei', 'Affiliation': ""Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China.""}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Li', 'Affiliation': ""Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China.""}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Lian', 'Affiliation': ""Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China.""}, {'ForeName': 'P P', 'Initials': 'PP', 'LastName': 'Wang', 'Affiliation': ""Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Quan', 'Affiliation': ""Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': ""Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China.""}, {'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Li', 'Affiliation': ""Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China.""}, {'ForeName': 'X D', 'Initials': 'XD', 'LastName': 'Liu', 'Affiliation': ""Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China.""}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Xie', 'Affiliation': ""Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China.""}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Huang', 'Affiliation': ""State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biological Products, School of Public Health, Xiamen University, Xiamen, People's Republic of China.""}, {'ForeName': 'S X', 'Initials': 'SX', 'LastName': 'Ge', 'Affiliation': ""State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biological Products, School of Public Health, Xiamen University, Xiamen, People's Republic of China.""}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Huang', 'Affiliation': ""Xiaolan Public Health Service Center, Zhongshan, People's Republic of China.""}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Liang', 'Affiliation': ""Xiaolan Public Health Service Center, Zhongshan, People's Republic of China.""}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'He', 'Affiliation': ""Xiaolan People's Hospital of Zhongshan City, Zhongshan, People's Republic of China.""}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Huang', 'Affiliation': ""Chen Xinhai Hospital of Xiaolan, Zhongshan, People's Republic of China.""}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Xia', 'Affiliation': ""Zhongshan Center for Disease Control and Prevention, Zhongshan, People's Republic of China.""}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Ng', 'Affiliation': 'State Key Laboratory for Emerging Infectious Diseases, Department of Microbiology and Research Centre of Infection and Immunology, The University of Hong Kong, Hong Kong, SAR.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory for Emerging Infectious Diseases, Department of Microbiology and Research Centre of Infection and Immunology, The University of Hong Kong, Hong Kong, SAR.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Xie', 'Affiliation': ""State Key Laboratory of Oncology in Southern China, Department of Epidemiology, Cancer Prevention Center, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China.""}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""State Key Laboratory of Oncology in Southern China, Department of Epidemiology, Cancer Prevention Center, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China.""}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Hong', 'Affiliation': ""State Key Laboratory of Oncology in Southern China, Department of Epidemiology, Cancer Prevention Center, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""State Key Laboratory of Oncology in Southern China, Department of Epidemiology, Cancer Prevention Center, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': ""Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China.""}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Xia', 'Affiliation': ""State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biological Products, School of Public Health, Xiamen University, Xiamen, People's Republic of China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biological Products, School of Public Health, Xiamen University, Xiamen, People's Republic of China. Electronic address: zhangj@xmu.edu.cn.""}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Cao', 'Affiliation': ""State Key Laboratory of Oncology in Southern China, Department of Epidemiology, Cancer Prevention Center, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. Electronic address: caosm@sysucc.org.cn.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz231']
3426,32114586,Effects of Edaravone on Neurological Function and Tumor Necrosis Factor Alpha and Interleukin 8 Levels in Patients with Cerebral Infarction.,"OBJECTIVE


The present study aimed to explore the effects of edaravone on neurological function, tumor necrosis factor α (TNF-α), and interleukin (IL)-8 levels in patients with cerebral infarction.
METHODS


A total of 96 patients with cerebral -infarction who were admitted to the department of neurology in our hospital were enrolled in the present study, and they were randomly assigned to Group A (n = 48) and Group B (n = 48). Group A was treated with conventional therapy plus edaravone for 2 weeks and Group B with conventional therapy alone for 2 weeks. Enzyme-linked immunosorbent assay was used to determine serum TNF-α and IL-8 levels before and after treatment, and Pearson correlation analysis was conducted to analyze the correlation between serum TNF-α and IL-8 levels as well as National Institutes of Health Stroke Scale (NIHSS) score.
RESULTS


After treatment, Group A had a lower NIHSS score and serum TNF-α and IL-8 levels as well as higher activities of daily living score than Group B (all p < 0.05). In addition, after treatment, no significant differences were observed between the 2 groups in terms of the presence of adverse reactions (p > 0.05). Pearson correlation analysis revealed a significant positive correlation between serum TNF-α and IL-8 levels as well as NIHSS score (r = -0.567 and r = -0.556, both p < 0.05).
CONCLUSION


Edaravone can improve the neurological function of patients without causing evident adverse reactions, thereby improving quality of life, which may be correlated to decreased serum TNF-α and IL-8 levels.",2020,"After treatment, Group A had a lower NIHSS score and serum TNF-α and IL-8 levels as well as higher activities of daily living score than Group B (all p < 0.05).","['Patients with Cerebral Infarction', '96 patients with cerebral -infarction who were admitted to the department of neurology in our hospital were enrolled in the present study', 'patients with cerebral infarction']","['conventional therapy plus edaravone', 'edaravone', 'Edaravone']","['serum TNF-α and IL-8 levels as well as National Institutes of Health Stroke Scale (NIHSS) score', 'Neurological Function and Tumor Necrosis Factor Alpha and Interleukin 8 Levels', 'NIHSS score', 'higher activities of daily living score', 'lower NIHSS score and serum TNF-α and IL-8 levels', 'presence of adverse reactions', 'quality of life', 'serum TNF-α and IL-8 levels', 'neurological function', 'neurological function, tumor necrosis factor α (TNF-α), and interleukin (IL)-8 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007785', 'cui_str': 'Cerebral Infarction'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027767', 'cui_str': 'Nervous System Physiology'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0034380'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}]",96.0,0.0377349,"After treatment, Group A had a lower NIHSS score and serum TNF-α and IL-8 levels as well as higher activities of daily living score than Group B (all p < 0.05).","[{'ForeName': 'Xiushan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of Hebei University of Engineering, Handan, China.'}, {'ForeName': 'Dongzhou', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of Hebei University of Engineering, Handan, China.'}, {'ForeName': 'Guozhu', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': 'Department of Neurosurgery, The Second Hospital of Hebei Medical University, Shijiazhuang, China, gzzzs2@163.com.'}]",European neurology,['10.1159/000505776']
3427,31397261,Effect of community members' willingness to disclose a mental disorder on their psychiatric symptom scores: analysis of data from two randomised controlled trials of mental health first aid training.,"AIMS


The prevalence of common mental disorders has not declined in high-income countries despite substantial increases in service provision. A possible reason for this lack of improvement is that greater willingness to disclose mental disorders might have led to increased reporting of psychiatric symptoms, thus masking reductions in prevalence. This masking hypothesis was tested using data from two trials of interventions that increased willingness to disclose and that also measured symptoms. Both interventions involved Mental Health First Aid (MHFA) training, which is known to reduce stigma, including unwillingness to disclose a mental health problem.
METHODS


A cross-lagged panel analysis was carried out on data from two large Australian randomised controlled trials of MHFA training. The first trial involved 1643 high school students in Year 10 (mean age 15.87 years), who were randomised to receive either teen MHFA training or physical first aid training as the control. The second trial involved 608 Australia public servants who were randomised to receive either eLearning MHFA, blended eLearning MHFA or eLearning physical first aid as the control. In both trials, willingness to disclose a mental disorder as described in vignettes and psychiatric symptoms (K6 scale) were measured pre-training, post-training and at 12-month follow-up.
RESULTS


Both trials found that MHFA training increased willingness to disclose. However, a cross-lagged panel analysis showed no effect of this change on psychiatric symptom scores.
CONCLUSIONS


Greater willingness to disclose did not affect psychiatric symptom scores. Because the trials increased willingness to disclose through a randomly assigned intervention, they provide a strong causal test of the masking hypothesis. It is therefore unlikely that changes in willingness to disclose are masking reductions in prevalence in the population.",2019,"The second trial involved 608 Australia public servants who were randomised to receive either eLearning MHFA, blended eLearning MHFA or eLearning physical first aid as the control.","['608 Australia public servants', '1643 high school students in Year 10 (mean age 15.87 years', ""community members' willingness to disclose a mental disorder on their psychiatric symptom scores"", 'A cross-lagged panel analysis was carried out on data from two large Australian randomised controlled trials of MHFA training']","['eLearning MHFA, blended eLearning MHFA or eLearning physical first aid as the control', 'MHFA training or physical first aid training as the control', 'Mental Health First Aid (MHFA) training', 'MHFA training']",['psychiatric symptom scores'],"[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0016143', 'cui_str': 'First Aid'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1276379', 'cui_str': 'First aid education'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",608.0,0.297707,"The second trial involved 608 Australia public servants who were randomised to receive either eLearning MHFA, blended eLearning MHFA or eLearning physical first aid as the control.","[{'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Jorm', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Mackinnon', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Hart', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Reavley', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Morgan', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796019000404']
3428,32089416,Delirium prevalence and prevention in patients with acute brain injury: A prospective before-and-after intervention study.,"OBJECTIVES


Knowledge regarding delirium prevention in patients with acute brain injury remains limited. We tested the hypothesis that an intervention bundle which targeted sedation, sleep, pain, and mobilisation would reduce delirium in patients with acute brain injury.
DESIGN


A prospective before-after intervention study: a five-month phase of standard care was followed by a six-month intervention phase.
SETTING


The neuro-intensive care unit, University Hospital of Copenhagen, Denmark.
MAIN OUTCOME MEASURES


The Intensive Care Delirium Screening Checklist was used to detect delirium. Primary outcome was delirium duration; secondary outcomes were delirium prevalence, ICU length of stay and one year mortality.
RESULTS


Forty-four patients were included during the standard care phase, and 50 during the intervention phase. Delirium was present in 90% of patients in the standard care group and 88% in the intervention group (p = 1.0), and time with delirium was 4 days vs 3.5 days (p = 0.26), respectively. Also, ICU length of stay (13 vs. 10.5 days (p = 0.4)) and the one year mortality (21% vs 12% (p = 0.38))) were similar between groups.
CONCLUSION


We found a high prevalence of delirium in patients with acute brain injury. The intervention bundle did not significantly reduce prevalence or duration of delirium, ICU length of stay or one year mortality.",2020,"Also, ICU length of stay (13 vs. 10.5 days (p = 0.4)) and the one year mortality (21% vs 12% (p = 0.38))) were similar between groups.
","['patients with acute brain injury', 'Forty-four patients were included during the standard care phase, and 50 during the intervention phase', 'The neuro-intensive care unit, University Hospital of Copenhagen, Denmark']",[],"['ICU length of stay', 'time with delirium', 'delirium duration; secondary outcomes were delirium prevalence, ICU length of stay and one year mortality', 'Delirium', 'year mortality', 'prevalence or duration of delirium, ICU length of stay or one year mortality', 'Delirium prevalence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085742', 'cui_str': 'Injuries, Acute Brain'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]",[],"[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",44.0,0.067984,"Also, ICU length of stay (13 vs. 10.5 days (p = 0.4)) and the one year mortality (21% vs 12% (p = 0.38))) were similar between groups.
","[{'ForeName': 'Laura Krone', 'Initials': 'LK', 'LastName': 'Larsen', 'Affiliation': 'Department of Neuroanaesthesiology, Rigshospitalet, University Hospital of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, Denmark. Electronic address: Laura.krone.larsen@regionh.dk.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Møller', 'Affiliation': 'Department of Neuroanaesthesiology, Rigshospitalet, University Hospital of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, Denmark. Electronic address: kirsten.moeller.01@regionh.dk.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Petersen', 'Affiliation': 'Department of Surgery, Zealand University Hospital, Lykkebækvej 1, 4600 Køge, Denmark. Electronic address: mapete@regionsjaelland.dk.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Egerod', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University Hospital of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, Denmark. Electronic address: Ingrid.egerod@regionh.dk.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2020.102816']
3429,31398593,Feasibility and clinical effects of theta burst stimulation in youth with major depressive disorders: An open-label trial.,"BACKGROUND


Conventional treatments for youth depression, such as antidepressants, have modest efficacy, side effects, and ongoing controversies regarding safety. Repetitive transcranial magnetic stimulation (rTMS), specifically theta burst stimulation (TBS), applied to the dorsolateral prefrontal cortex (DLPFC) has demonstrated efficacy for the treatment of depression in adults. However, the feasibility and clinical response to TBS for youth depression has yet to be explored.
METHODS


Twenty participants between the ages of 16 to 24 years old with MDD were recruited. The intervention consisted of 10 treatment sessions over the course of two weeks, in which participants received intermittent TBS and continuous TBS stimulation to the left and right DLPFC, respectively. Change in the Hamilton Rating Scale for Depression (HRSD-17) score was the primary outcome. Clinical assessments occurred at baseline, after the fifth treatment session, and within a week after treatment completion.
RESULTS


Of the twenty participants, eighteen received all TBS sessions, and seventeen completed all clinical assessments. There was a significant reduction in depressive symptoms following treatment completion (p < 0.001). Four of the twenty patients had more than 50% reduction in their depressive symptoms, two of whom achieved remission. All participants received and tolerated at least six daily TBS treatments with no major adverse events.
LIMITATIONS


Study was an uncontrolled, open-label design.
CONCLUSION


Ten sessions of TBS was feasible, well tolerated, and appeared to have clinical effects for the treatment of depressed youth. Future sham-controlled randomized trials are warranted to validate these findings in a larger cohort of youth depression.",2019,There was a significant reduction in depressive symptoms following treatment completion (p < 0.001).,"['Twenty participants between the ages of 16 to 24 years old with MDD were recruited', 'youth with major depressive disorders', 'adults', 'twenty participants']","['intermittent TBS and continuous TBS stimulation', 'TBS', 'Repetitive transcranial magnetic stimulation (rTMS), specifically theta burst stimulation (TBS', 'theta burst stimulation']","['Hamilton Rating Scale for Depression (HRSD-17) score', 'depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",20.0,0.0452684,There was a significant reduction in depressive symptoms following treatment completion (p < 0.001).,"[{'ForeName': 'Prabhjot', 'Initials': 'P', 'LastName': 'Dhami', 'Affiliation': ""Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Institute of Medical Science, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, Ontario, M5T 1R8, Canada.'}, {'ForeName': 'Sravya', 'Initials': 'S', 'LastName': 'Atluri', 'Affiliation': 'Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Institute of Biomaterial and Biomedical Engineering, Rosebrugh Building, Room 407, 164 College St, Toronto, Ontario, M5S 3G9, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ""Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, Ontario, M5T 1R8, Canada; Institute of Medical Science, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Darren B', 'Initials': 'DB', 'LastName': 'Courtney', 'Affiliation': 'Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, Ontario, M5T 1R8, Canada.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Croarkin', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': ""Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, Ontario, M5T 1R8, Canada; Institute of Medical Science, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': ""Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, Ontario, M5T 1R8, Canada; Institute of Medical Science, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Faranak', 'Initials': 'F', 'LastName': 'Farzan', 'Affiliation': ""Centre for Addiction and Mental Health, 1001 Queen St. W, Toronto, Ontario, M6J 1A8, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, Ontario, M5T 1R8, Canada; Institute of Medical Science, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle, Toronto, Ontario, M5S 1A8, Canada; School of Mechatronic Systems Engineering, Simon Fraser University, 250-13450 102 Avenue, Surrey, British Columbia, V3T 0A3, Canada. Electronic address: ffarzan@sfu.ca.""}]",Journal of affective disorders,['10.1016/j.jad.2019.07.084']
3430,32090464,Association between perioperative intraperitoneal local anaesthetic infusion and long-term survival and cancer recurrence after colectomy: follow-up analysis of a previous randomized controlled trial.,"BACKGROUND


High concentrations of local anaesthetic have an anti-proliferative effect on colonic cancer in vitro. Intraperitoneal local anaesthetic (IPLA) has shown analgesic benefit and improved recovery in the perioperative setting. The long-term effects of IPLA in colon cancer resection have not been examined. This study aims to review the survival and oncological outcomes of a previously conducted trial that compared perioperative IPLA with placebo.
METHODS


Sixty patients underwent colonic resection for benign and malignant disease as part of a double-blinded, randomized, placebo-controlled study between September 2008 and November 2009. The IPLA group received instillation of intraperitoneal ropivacaine before dissection followed by a 3-day infusion. The placebo group was treated identically but with 0.9% saline solution. A follow-up analysis was conducted to evaluate overall survival, disease-free survival and recurrence specifically for patients undergoing resection for stages I-III colon cancer. Kaplan-Meier analysis was performed, and the log-rank test was used to evaluate difference in survival between groups.
RESULTS


Thirty-seven of the 60 patients had stages I-III colon cancer and were included in this analysis. Nineteen patients were in the placebo group. There was no significant difference in overall survival or all-cause mortality. There was a higher incidence of cancer-specific mortality in the local anaesthetic group (P < 0.046).
CONCLUSION


It does not appear that IPLA is associated with a significant survival benefit in patients with colonic malignancy undergoing colectomy. Other studies are needed to analyse the long-term outcomes.",2020,"There was a higher incidence of cancer-specific mortality in the local anaesthetic group (P < 0.046).
","['Thirty-seven of the 60 patients had stages I-III colon cancer', 'Nineteen patients were in the placebo group', 'Sixty patients underwent', 'controlled study between September 2008 and November 2009', 'patients with colonic malignancy undergoing colectomy', 'patients undergoing resection for stages I-III colon cancer']","['IPLA', 'placebo', 'intraperitoneal ropivacaine', 'colonic resection', 'Intraperitoneal local anaesthetic (IPLA', 'saline solution']","['survival benefit', 'overall survival, disease-free survival and recurrence', 'cancer recurrence', 'cancer-specific mortality', 'survival', 'overall survival']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0009274', 'cui_str': 'Large Bowel Resection'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C2830173', 'cui_str': 'iPLA(2)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",19.0,0.762434,"There was a higher incidence of cancer-specific mortality in the local anaesthetic group (P < 0.046).
","[{'ForeName': 'Wiremu S', 'Initials': 'WS', 'LastName': 'MacFater', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Weisi', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ahmed W H', 'Initials': 'AWH', 'LastName': 'Barazanchi', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Hoani S', 'Initials': 'HS', 'LastName': 'MacFater', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lightfoot', 'Affiliation': 'Department of Anaesthesia and Pain Medicine, Counties Manukau Health, Auckland, New Zealand.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Svirskis', 'Affiliation': 'Department of Pharmacy, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Arman A', 'Initials': 'AA', 'LastName': 'Kahokehr', 'Affiliation': 'Division of Surgery and Anaesthetics, Northern Adelaide Local Health Network, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Hill', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}]",ANZ journal of surgery,['10.1111/ans.15753']
3431,32107748,Evaluation of Mortality During Long-Term Treatment with Tafamidis for Transthyretin Amyloidosis with Polyneuropathy: Clinical Trial Results up to 8.5 Years.,"INTRODUCTION


The effects of tafamidis on mortality in Val30Met and non-Val30Met patients with transthyretin amyloidosis with polyneuropathy (ATTR-PN) were evaluated.
METHODS


The analyses were based on cumulative data from the Val30Met patients in the 18-month double-blind registration study and its 12-month open-label extension study, the non-Val30Met patients of the 12-month open-label study, and both patient groups in the ongoing 10-year extension study. Kaplan-Meier analyses of time to death from first treatment dose were performed. For the Val30Met group, two treatment groups were analyzed: those who received tafamidis in both the parent and extension studies (T-T) and those who received placebo in the parent study and switched to tafamidis in the extension studies (P-T).
RESULTS


Kaplan-Meier estimates (95% confidence interval [CI]) were available up to 9 years for the Val30Met group, at which time 85.9% (53.1-96.4) and 91.1% (77.9-96.6) of the patients in the T-T and P-T groups, respectively, were alive. For the non-Val30Met group, estimates were available up to 8 years from the first dose, and the percentage of patients alive was 75.9% (47.7-90.2).
CONCLUSION


Long-term tafamidis treatment may confer survival benefit in patients with ATTR-PN.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00409175, NCT00791492, NCT00630864, and NCT00925002.",2020,"The effects of tafamidis on mortality in Val30Met and non-Val30Met patients with transthyretin amyloidosis with polyneuropathy (ATTR-PN) were evaluated.
","['patients with ATTR-PN', 'Val30Met and non-Val30Met patients with transthyretin amyloidosis with polyneuropathy (ATTR-PN']",['placebo'],"['Mortality', 'survival benefit', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2751492', 'cui_str': 'Familial Transthyretin Cardiac Amyloidosis'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.05698,"The effects of tafamidis on mortality in Val30Met and non-Val30Met patients with transthyretin amyloidosis with polyneuropathy (ATTR-PN) were evaluated.
","[{'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Merlini', 'Affiliation': 'Foundation IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Coelho', 'Affiliation': ""Andrade's Centre, Hospital Santo António, Centro Hospitalar do Porto, Porto, Portugal.""}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Waddington Cruz', 'Affiliation': 'CEPARM National Amyloidosis Referral Center, University Hospital, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Stewart', 'Affiliation': 'Pfizer Inc, New York, NY, USA. michelle.stewart@pfizer.com.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Ebede', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}]",Neurology and therapy,['10.1007/s40120-020-00180-w']
3432,31391223,"Efficacy and safety of ralinepag, a novel oral IP agonist, in PAH patients on mono or dual background therapy: results from a phase 2 randomised, parallel group, placebo-controlled trial.","PURPOSE


This phase 2 study was designed to assess the efficacy, safety and tolerability of immediate-release orally administered ralinepag, a selective, non-prostanoid prostacyclin receptor agonist with a 24-h terminal half-life, compared to placebo in adult patients with symptomatic pulmonary arterial hypertension (PAH).
METHODS


61 PAH patients who were receiving standard care, including mono or dual PAH-targeted background therapy were randomised 2:1 to ralinepag (n=40) or placebo (n=21). The starting dose of ralinepag was 10 μg twice daily. Dosage was then up-titrated as tolerated over the course of the 9-week dose-titration period, to a maximum total daily dose of 600 μg (300 μg twice daily). The primary efficacy end-point was the absolute change in pulmonary vascular resistance (PVR) from baseline to week 22. Additional end-points included percentage change in PVR from baseline, other haemodynamic parameters, 6-min walk distance (6MWD) and safety and tolerability.
RESULTS


Ralinepag significantly decreased PVR by 163.9 dyn·s·cm -5  compared to an increase of 0.7 dyn·s·cm -5  with placebo (p=0.02); the least-squares mean change from baseline PVR was -29.8% compared with placebo (p=0.03). 6MWD increased from baseline by 36.2 m with ralinepag and 29.4 m with placebo (p=0.90). Serious adverse events occurred in 10% of ralinepag patients and 29% of placebo patients. Study discontinuations occurred in 13% of ralinepag patients and 10% of placebo patients.
SUMMARY


Ralinepag reduced PVR compared with placebo in PAH patients on mono (41%) or dual combination (59%) background therapy.",2019,6MWD increased from baseline by 36.2 m with ralinepag and 29.4 m with placebo (p=0.90).,"['Sixty-one PAH patients who were receiving standard of care, including mono or dual PAH -targeted background therapy', 'adult patients with symptomatic pulmonary arterial hypertension (PAH']","['ralinepag', 'placebo', 'immediate-release (IR) orally administered ralinepag, a selective, non-prostanoid prostacyclin receptor (IP) agonist']","['efficacy, safety and tolerability', '6MWD', 'PVR', 'percentage change in PVR from baseline, other hemodynamic parameters, 6-minute walk distance (6MWD), and safety and tolerability', 'absolute change in pulmonary vascular resistance (PVR', 'Efficacy and safety', 'Serious adverse events']","[{'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}]","[{'cui': 'C4508023', 'cui_str': '2-((4-(((4-chlorophenyl)(phenyl)carbamoyl)oxy)methyl)cyclohexyl)methoxy)acetate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0033554', 'cui_str': 'Prostanoids'}, {'cui': 'C4521473', 'cui_str': 'Prostacyclin receptor agonist'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",61.0,0.618949,6MWD increased from baseline by 36.2 m with ralinepag and 29.4 m with placebo (p=0.90).,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'Pulmonary/Critical Care, UT Southwestern Medical Center, William P. Clements Jr University Hospital, Dallas, TX, USA.'}, {'ForeName': 'Harrison', 'Initials': 'H', 'LastName': 'Farber', 'Affiliation': 'Pulmonary and Critical Care, Boston Medical Center, Boston University, Boston, MA, USA.'}, {'ForeName': 'Arsen', 'Initials': 'A', 'LastName': 'Ristic', 'Affiliation': 'Dept of Cardiology, Clinical Center of Serbia and Belgrade University School of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Vallerie', 'Initials': 'V', 'LastName': 'McLaughlin', 'Affiliation': 'Cardiovascular Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Arena Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Jinkun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Arena Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Preston', 'Initials': 'P', 'LastName': 'Klassen', 'Affiliation': 'Arena Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Shanahan', 'Affiliation': 'Hessian Pharmaceuticals, Hayward, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Grundy', 'Affiliation': 'Arena Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Hoffmann', 'Affiliation': 'Arena Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cabell', 'Affiliation': 'Arena Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Escribano Subías', 'Affiliation': 'Dept of Cardiology, Hospital Universitario 12 de Octubre, Complutense University, Madrid, Spain.'}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Sood', 'Affiliation': 'University of Texas, Houston, TX, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Keogh', 'Affiliation': ""Heart Transplant, St Vincent's Hospital, Sydney, Australia.""}, {'ForeName': 'Gwyn', 'Initials': 'G', 'LastName': ""D'Souza"", 'Affiliation': 'Arena Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Rubin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of California, San Diego, CA, USA ljrubin@ucsd.edu.'}]",The European respiratory journal,['10.1183/13993003.01030-2019']
3433,31389599,Therapy with ticagrelor for ST-elevated acute coronary syndrome accompanied by diabetes mellitus.,"OBJECTIVE


To investigate the protective effect of ticagrelor on the myocardium of patients with ST-elevated acute coronary syndrome accompanied by diabetes mellitus.
PATIENTS AND METHODS


210 patients with diabetes mellitus receiving emergency percutaneous coronary intervention (PCI) due to ST-elevated acute coronary syndrome from December 2014 to June 2018 in the Hospital were selected and randomly divided into ticagrelor group and clopidogrel group. The myocardial microcirculation perfusion was evaluated via ST-segment elevation resolution (STR) in electrocardiogram (ECG) and myocardial blush grade (MBG). Myocardial necrosis markers, including creatine kinase (CK), CK-MB, and cardiac troponin I (cTnI), were evaluated. Moreover, the cardiac function was assessed using brain natriuretic peptide (BNP) level and left ventricular ejection fraction (LVEF). Finally, patients were followed up for one month on average, and the adverse cardiovascular and bleeding events were recorded.
RESULTS


The results showed that CK, CK-MB, cTnI, and BNP levels in ticagrelor group were lower than those in clopidogrel group, and the differences were statistically significant (p<0.05). Thrombolysis in myocardial infarction (TIMI) flow grading after the operation had no statistically significant difference between the two groups, and the usage rate of tirofiban in ticagrelor group was lower than that in clopidogrel group (p<0.05). Besides, the myocardial microcirculation perfusion level after the operation in ticagrelor group was significantly higher than that in clopidogrel group. The proportions of STR ≥50% in ECG and MBG2 in ticagrelor group were significantly higher than those in clopidogrel group (p<0.01). The incidence rate of mild bleeding in ticagrelor group was higher than that in clopidogrel group (p<0.05).
CONCLUSIONS


The application of ticagrelor in the treatment of ST-elevated acute coronary syndrome accompanied by diabetes mellitus can increase the level of myocardial microcirculation perfusion and improve the left heart function.",2019,"Thrombolysis in myocardial infarction (TIMI) flow grading after the operation had no statistically significant difference between the two groups, and the usage rate of tirofiban in ticagrelor group was lower than that in clopidogrel group (p<0.05).","['ST-elevated acute coronary syndrome accompanied by diabetes mellitus', '210 patients with diabetes mellitus receiving emergency percutaneous coronary intervention (PCI) due to ST-elevated acute coronary syndrome from December 2014 to June 2018 in the Hospital', 'patients with ST-elevated acute coronary syndrome accompanied by diabetes mellitus']","['ticagrelor', 'ticagrelor group and clopidogrel', 'clopidogrel']","['adverse cardiovascular and bleeding events', 'incidence rate of mild bleeding', 'usage rate of tirofiban', 'myocardial microcirculation perfusion', 'myocardial infarction (TIMI) flow grading', 'Myocardial necrosis markers, including creatine kinase (CK), CK-MB, and cardiac troponin', 'CK, CK-MB, cTnI, and BNP levels', 'brain natriuretic peptide (BNP) level and left ventricular ejection fraction (LVEF', 'myocardial microcirculation perfusion level', 'ST-segment elevation resolution (STR) in electrocardiogram (ECG) and myocardial blush grade (MBG']","[{'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1532297', 'cui_str': 'Emergency percutaneous coronary intervention'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C3854442', 'cui_str': 'Myocardial necrosis marker'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0523584', 'cui_str': 'Creatine kinase MB measurement'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0005874', 'cui_str': 'Blushings'}]",210.0,0.0151215,"Thrombolysis in myocardial infarction (TIMI) flow grading after the operation had no statistically significant difference between the two groups, and the usage rate of tirofiban in ticagrelor group was lower than that in clopidogrel group (p<0.05).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Special Examination, Binzhou City Center Hospital, Binzhou, China. 285880332@qq.com.'}, {'ForeName': 'L-Y', 'Initials': 'LY', 'LastName': 'Ding', 'Affiliation': ''}, {'ForeName': 'X-Z', 'Initials': 'XZ', 'LastName': 'Li', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201908_18662']
3434,31374515,Low-fusing porcelain glaze application does not damage the fatigue strength of Y-TZP.,"This study evaluated and compared the effects of two glaze application methods (brush and spray) on the fatigue strength and surface characteristics (topography and roughness) of a translucent yttrium stabilized partially tetragonal zirconia polycrystal ceramic (Y-TZP) prior to and after grinding. Disc-shaped specimens of translucent Y-TZP (Vita YZ-HT; Vita-Zahnfabrik) were processed (ISO 6872-2015) and randomly allocated into 6 groups, according to the surface treatments performed on the tensile surface: Ctrl - as-sintered (no treatment); Gr - grinding with a diamond bur (181 μm-grit; #3101G); Br - glaze obtained from a powder-liquid mix and applied by brush (Vita Akzent; Vita Zahnfabrik); Sp - glaze application via spray (Vita Akzent Plus; Vita Zahnfabrik); Gr + Br and Gr + Sp - association of grinding + respective glaze method. Analyses of surface roughness (Ra and Rz), fatigue strength (staircase method), surface topography and fractography were carried out. The as-sintered condition had the smoothest surface, while grinding led to the rougher and more heterogeneous topography. Both glaze application methods showed a potential for topography evenness (smoothening effect), while the glaze spray method led to thinner layers of material, showing a limitation in reducing the roughness compared to the brush method. No deleterious effect on fatigue strength of the Y-TZP could be observed, as the glaze-spray application on the as-sintered surface showed the highest values. Fractography depicted two distinct fracture origin regions: from defects in the surface/sub-surface region for the Ctrl and Gr groups; and at the zirconia-glaze layer interface for Br, Sp, Gr + Br and Gr + Sp. The clinical relevance of this work is that the tested glaze application methods did not damage the fatigue strength of the tested Y-TZP.",2019,"No deleterious effect on fatigue strength of the Y-TZP could be observed, as the glaze-spray application on the as-sintered surface showed the highest values.",[],"['Br - glaze obtained from a powder-liquid mix and applied by brush (Vita Akzent; Vita Zahnfabrik); Sp - glaze application via spray (Vita Akzent', 'Ctrl - as-sintered (no treatment); Gr - grinding with a diamond bur', 'glaze application methods (brush and spray', 'translucent yttrium stabilized partially tetragonal zirconia polycrystal ceramic (Y-TZP', 'Plus; Vita Zahnfabrik); Gr\xa0+\xa0Br and Gr\xa0+\xa0Sp - association of grinding\xa0+\xa0respective glaze method']","['surface roughness (Ra and Rz), fatigue strength (staircase method), surface topography and fractography', 'fatigue strength and surface characteristics (topography and roughness', 'fatigue strength']",[],"[{'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding (procedure)'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur (physical object)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0522503', 'cui_str': 'Translucent (qualifier value)'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004083', 'cui_str': 'Association'}]","[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0449588', 'cui_str': 'Surface characteristics (attribute)'}]",,0.0154137,"No deleterious effect on fatigue strength of the Y-TZP could be observed, as the glaze-spray application on the as-sintered surface showed the highest values.","[{'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'MSciD and PhD Post-graduate Program in Oral Science, Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: camila-svs@hotmail.com.'}, {'ForeName': 'Gabriel Kalil Rocha', 'Initials': 'GKR', 'LastName': 'Pereira', 'Affiliation': 'MSciD Post-graduate Program in Dentistry, School of Dentistry, Meridional Faculty - IMED, Passo Fundo, Rio Grande do Sul, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Kiara Serafini', 'Initials': 'KS', 'LastName': 'Dapieve', 'Affiliation': 'MSciD and PhD Post-graduate Program in Oral Science, Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: kiara_s_d@hotmail.com.'}, {'ForeName': 'Marilia Pivetta', 'Initials': 'MP', 'LastName': 'Rippe', 'Affiliation': 'MSciD and PhD Post-graduate Program in Oral Science, Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: mariliarip@hotmail.com.'}, {'ForeName': 'Marco Cícero', 'Initials': 'MC', 'LastName': 'Bottino', 'Affiliation': 'School of Dentistry, Dept. of Cariology, Restorative Sciences, Endodontics, University of Michigan, Ann Arbor, USA. Electronic address: mbottino@umich.edu.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Post-graduate Program in Oral Science, Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.07.022']
3435,31390002,Effects of Nicotinamide Riboside on Endocrine Pancreatic Function and Incretin Hormones in Nondiabetic Men With Obesity.,"OBJECTIVE


Augmenting nicotinamide adenine dinucleotide (NAD+) metabolism through dietary provision of NAD+ precursor vitamins translates to improved glucose handling in rodent models of obesity and diabetes. Preclinical evidence suggests that the NAD+/SIRT1 axis may be implicated in modulating important gut-related aspects of glucose regulation. We sought to test whether NAD+ precursor supplementation with nicotinamide riboside (NR) affects β-cell function, α-cell function, and incretin hormone secretion as well as circulating bile acid levels in humans.
DESIGN


A 12-week randomized, double-blind, placebo-controlled, parallel-group trial in 40 males with obesity and insulin resistance allocated to NR at 1000 mg twice daily (n = 20) or placebo (n = 20). Two-hour 75-g oral glucose tolerance tests were performed before and after the intervention, and plasma concentrations of glucose, insulin, C-peptide, glucagon, glucagon-like peptide 1 (GLP-1), and glucose-dependent insulinotropic polypeptide (GIP) were determined. β-Cell function indices were calculated based on glucose, insulin, and C-peptide measurements. Fasting plasma concentrations of bile acids were determined.
RESULTS


NR supplementation during 12 weeks did not affect fasting or postglucose challenge concentrations of glucose, insulin, C-peptide, glucagon, GLP-1, or GIP, and β-cell function did not respond to the intervention. Additionally, no changes in circulating adipsin or bile acids were observed following NR supplementation.
CONCLUSION


The current study does not provide evidence to support that dietary supplementation with the NAD+ precursor NR serves to impact glucose tolerance, β-cell secretory capacity, α-cell function, and incretin hormone secretion in nondiabetic males with obesity. Moreover, bile acid levels in plasma did not change in response to NR supplementation.",2019,"RESULTS


NR supplementation during 12 weeks neither affected fasting nor post-glucose challenge concentrations of glucose, insulin, C-peptide, glucagon, GLP-1, or GIP, and β-cell function did not respond to the intervention.","['humans', 'obese, non-diabetic males', 'obese, non-diabetic men', '40 obese, insulin-resistant males allocated to NR 1,000 mg twice daily (n = 20) or']","['NAD+ precursor supplementation with nicotinamide riboside (NR', 'placebo', 'nicotinamide riboside']","['glucose, insulin, and C-peptide measurements', 'endocrine pancreatic function and incretin hormones', 'β-cell function indices', 'circulating adipsin or bile acids', 'Fasting plasma concentrations of bile acids', 'plasma concentrations of glucose, insulin, C-peptide, glucagon, GLP-1, and GIP', 'fasting nor post-glucose challenge concentrations of glucose, insulin, C-peptide, glucagon, GLP-1, or GIP, and β-cell function']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0068711', 'cui_str': 'pyridinium, 3-(aminocarbonyl)-1-beta-D-ribofuranosyl-'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement (procedure)'}, {'cui': 'C0232786', 'cui_str': 'Pancreatic function'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0033457', 'cui_str': 'Properdin Factor D'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",40.0,0.138064,"RESULTS


NR supplementation during 12 weeks neither affected fasting nor post-glucose challenge concentrations of glucose, insulin, C-peptide, glucagon, GLP-1, or GIP, and β-cell function did not respond to the intervention.","[{'ForeName': 'Ole L', 'Initials': 'OL', 'LastName': 'Dollerup', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Samuel A J', 'Initials': 'SAJ', 'LastName': 'Trammell', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Gillum', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jonas T', 'Initials': 'JT', 'LastName': 'Treebak', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Department of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-01081']
3436,32107571,Effects of a dopamine agonist on trusting behaviors in females.,"Trust is central to bonding and cooperation. In many social interactions, individuals need to trust another person exclusively on the basis of their subjective impressions of the other's trustworthiness. Such impressions can be formed from social information from faces (e.g., facial trustworthiness and attractiveness) and guide trusting behaviors via activations of dopaminergic brain regions. However, the specific dopaminergic effects on impression-based trust are to date elusive. Here, in a double-blind, placebo-controlled, within-subject design, we administrated a D2/D3 dopamine agonist (pramipexole) to 28 healthy females who subsequently played a one-shot trust game with partners of varying facial trustworthiness. Our results show that by minimizing facial attractiveness information, we could isolate the specific effects of facial trustworthiness on trust in unknown partners. Despite no modulation of trustworthiness impressions, pramipexole intake significantly impacted trusting behaviors. Notably, these effects of pramipexole on trusting behaviors interacted with participants' hormonal contraceptive use. In particular, after pramipexole intake, trust significantly decreased in hormonal contraceptive non-users. This study fills an important gap in the experimental literature on trust and its neural dynamics, unearthing the cognitive and neural modulations of trusting behaviors based on trustworthiness impressions of others.",2020,"Despite no modulation of trustworthiness impressions, pramipexole intake significantly impacted trusting behaviors.","['females', '28 healthy females who subsequently played a one-shot trust game with partners of varying facial trustworthiness']","['placebo', 'dopamine agonist', 'pramipexole', 'D2/D3 dopamine agonist (pramipexole']",['hormonal contraceptive non-users'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0178601', 'cui_str': 'Dopaminergic Agonists'}, {'cui': 'C0074710', 'cui_str': 'Pramipexole'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}]",28.0,0.0589719,"Despite no modulation of trustworthiness impressions, pramipexole intake significantly impacted trusting behaviors.","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Bellucci', 'Affiliation': 'Department of Psychology I, University of Lübeck, 23562, Lübeck, Germany. gbellucc@gmail.com.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Münte', 'Affiliation': 'Department of Neurology, Universitätsklinikum Schleswig-Holstein, 23538, Lübeck, Germany.'}, {'ForeName': 'Soyoung Q', 'Initials': 'SQ', 'LastName': 'Park', 'Affiliation': 'Department of Psychology I, University of Lübeck, 23562, Lübeck, Germany.'}]",Psychopharmacology,['10.1007/s00213-020-05488-x']
3437,30560316,Autonomic Neuromodulation Acutely Ameliorates Left Ventricular Strain in Humans.,"Low-level transcutaneous vagus nerve stimulation at the tragus (LLTS) is anti-adrenergic. We aimed to evaluate the acute effects of LLTS on left ventricular (LV) function and autonomic tone. Patients with diastolic dysfunction and preserved LV ejection fraction were enrolled in a prospective, randomized, double-blind, 2 × 2 cross-over study. Patients received two separate, 1-h sessions, at least 1 day apart, of active LLTS (20 Hz, 1 mA below the discomfort threshold) and sham stimulation. Echocardiography was performed after LLTS or sham stimulation to assess cardiac function. A 5-min ECG was performed to assess heart rate variability (HRV). Twenty-four patients were enrolled. LV global longitudinal strain improved by 1.8 ± 0.9% during active LLTS compared to sham stimulation (p = 0.001). Relative to baseline, HRV frequency domain components (low frequency, high frequency, and their ratio) were favorably altered after LLTS compared to sham stimulation (all p < 0.05). We concluded that LLTS acutely ameliorates cardiac mechanics by modulating the autonomic tone. Trial registration: NCT02983448.",2019,"Relative to baseline, HRV frequency domain components (low frequency, high frequency, and their ratio) were favorably altered after LLTS compared to sham stimulation (all p < 0.05).","['Patients with diastolic dysfunction and preserved LV ejection fraction', 'Twenty-four patients were enrolled', 'Humans']","['LLTS', 'LLTS or sham stimulation', 'Low-level transcutaneous vagus nerve stimulation at the tragus (LLTS', 'active LLTS']","['cardiac mechanics', 'left ventricular (LV) function and autonomic tone', 'HRV frequency domain components (low frequency, high frequency, and their ratio', 'heart rate variability (HRV', 'LV global longitudinal strain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction (finding)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0229312', 'cui_str': 'Tragus structure'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]",24.0,0.269688,"Relative to baseline, HRV frequency domain components (low frequency, high frequency, and their ratio) were favorably altered after LLTS compared to sham stimulation (all p < 0.05).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'University of Oklahoma Health Sciences Center, 800 Stanton L Young Blvd Suite, Oklahoma City, OK, 5400, USA.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Asad', 'Affiliation': 'University of Oklahoma Health Sciences Center, 800 Stanton L Young Blvd Suite, Oklahoma City, OK, 5400, USA.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Elkholey', 'Affiliation': 'University of Oklahoma Health Sciences Center, 800 Stanton L Young Blvd Suite, Oklahoma City, OK, 5400, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Scherlag', 'Affiliation': 'University of Oklahoma Health Sciences Center, 800 Stanton L Young Blvd Suite, Oklahoma City, OK, 5400, USA.'}, {'ForeName': 'Sunny S', 'Initials': 'SS', 'LastName': 'Po', 'Affiliation': 'University of Oklahoma Health Sciences Center, 800 Stanton L Young Blvd Suite, Oklahoma City, OK, 5400, USA.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Stavrakis', 'Affiliation': 'University of Oklahoma Health Sciences Center, 800 Stanton L Young Blvd Suite, Oklahoma City, OK, 5400, USA. stavros-stavrakis@ouhsc.edu.'}]",Journal of cardiovascular translational research,['10.1007/s12265-018-9853-6']
3438,31389607,Observation of efficacy of TACE combined with HIFU on patients with middle-advanced liver cancer.,"OBJECTIVE


To study the efficacy of transarterial chemoembolization (TACE) combined with high-intensity focused ultrasound (HIFU) in patients with middle-advanced liver cancer.
PATIENTS AND METHODS


A total of 100 patients with middle-advanced liver cancer treated in our hospital from January 2015 to January 2018 were selected and randomly divided into TACE group (control group, n=50) and TACE combined with HIFU group (experimental group, n=50) according to different therapeutic regimens. The efficacy was observed after the operation, the blood was collected to detect the postoperative liver function indexes aspartate aminotransferase (AST) and alanine aminotransferase (ALT), the postoperative complications were observed. Also, the immune indexes cluster of differentiation 3+ (CD3+), CD4+, and CD8+ were determined. Moreover, the quality of life (QOL) score was compared between the two groups, the 1-, 2-, 3-, and 5-year survival rates were observed after the operation. Also, the changes in the levels of tumor markers α-L-fucosidase (AFU), alpha-fetoprotein (AFP), carbohydrate antigen 19-9 (CA19-9), and carcinoembryonic antigen (CEA) were observed.
RESULTS


In experimental group, the levels of AST, ALT, and blood urea nitrogen (BUN) after the operation were significantly decreased (p<0.05), while the postoperative efficacy was significantly superior to that in control group (p<0.05). The incidence of postoperative complications was significantly reduced (p<0.05), the levels of CD3+, CD4+, CD8+, and natural killer (NK) cells were markedly increased (p<0.05). Also, the QOL score was evidently better than that in control group (p<0.05) and the 1-, 2-, 3-, and 5- year survival rates after the operation were evidently higher than those in control group (p<0.05). After treatment, the levels of AFU, AFP, CA19-9, and CEA were remarkably lower than those before treatment in both groups, while they were remarkably lower in experimental group than those in control group (p<0.05).
CONCLUSIONS


TACE combined with HIFU in the treatment of patients with middle-advanced liver cancer can restore the hepatic metabolism, enhance the immunity, improve the QOL, prolong the survival time of patients, and significantly reduce the tumor markers. Also, it has fewer adverse reactions and definite overall efficacy, which is worthy of popularization and application.",2019,"The incidence of postoperative complications was significantly reduced (p<0.05),","['100 patients with middle-advanced liver cancer treated in our hospital from January 2015 to January 2018', 'patients with middle-advanced liver cancer']","['TACE combined with HIFU', 'transarterial chemoembolization (TACE) combined with high-intensity focused ultrasound (HIFU', 'TACE']","['incidence of postoperative complications', 'postoperative liver function indexes aspartate aminotransferase (AST) and alanine aminotransferase (ALT), the postoperative complications', 'QOL score', 'immune indexes cluster of differentiation 3+ (CD3+), CD4+, and CD8', 'levels of AFU, AFP, CA19-9, and CEA', 'postoperative efficacy', 'levels of CD3+, CD4+, CD8+, and natural killer (NK) cells', '5-year survival rates', 'survival time', 'levels of AST, ALT, and blood urea nitrogen (BUN', 'quality of life (QOL) score', '5- year survival rates', 'levels of tumor markers α-L-fucosidase (AFU), alpha-fetoprotein (AFP), carbohydrate antigen 19-9 (CA19-9), and carcinoembryonic antigen (CEA']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0345904', 'cui_str': 'Cancer of Liver'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0529196', 'cui_str': 'ADAM-17 Protein'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach (qualifier value)'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0441583', 'cui_str': 'High intensity focused ultrasound (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C0034380'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0682743', 'cui_str': 'Fucosidase (substance)'}, {'cui': 'C0002210', 'cui_str': 'alpha-Fetoproteins'}, {'cui': 'C0201551', 'cui_str': 'CA 199 measurement'}, {'cui': 'C0007082', 'cui_str': 'Antigens, CD66e'}]",2018.0,0.0157888,"The incidence of postoperative complications was significantly reduced (p<0.05),","[{'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Nursing, First People's Hospital of Jingzhou City, First Affiliated Hospital of Yangtze University, Jingzhou, China. sunye1969@163.com.""}, {'ForeName': 'S-Q', 'Initials': 'SQ', 'LastName': 'Bian', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lv', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kou', 'Affiliation': ''}, {'ForeName': 'H-L', 'Initials': 'HL', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'S-S', 'Initials': 'SS', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Z-S', 'Initials': 'ZS', 'LastName': 'Cao', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201908_18653']
3439,31734452,Modified global alignment and proportion scoring with body mass index and bone mineral density (GAPB) for improving predictions of mechanical complications after adult spinal deformity surgery.,"BACKGROUND CONTEXT


The global alignment and proportion (GAP) score for predicting mechanical complications of adult spinal deformity (ASD) surgery has limitations due to its lack of bone quality and patient characteristics such as obesity, which has a significant impact on surgical outcome, especially in the elderly population with ASD.
PURPOSE


This study aimed to improve the predictability of GAP score after ASD surgery by adding body mass index (BMI) and bone mineral density (BMD).
DESIGN


A retrospective comparative study.
PATIENT SAMPLE


Between January 2009 and December 2016, 203 consecutive patients with ASD underwent corrective fusion of more than 4 levels and were followed up for more than 2 years.
OUTCOME MEASURES


The ability of the Scoliosis Research Society (SRS)-Schwab classification, age-adjusted alignment goals, GAP score, and modified global alignment and proportion scoring with BMI and BMD (GAPB) to predict mechanical failure was compared by calculating the area under the receiver operating characteristic curve (AUC).
METHODS


The GAPB was developed and validated in patients randomly assigned to derivation (n=125, 61.6%) and validation (n=78, 38.4%) cohorts. Considering multicollinearity, a multivariable logistic regression model with BMD, BMI, and the GAP score was constructed.
RESULTS


Patients' average age was 66.8±12.28 years, and they were followed for an average of 30.54±10.25 months. Fifty-five patients of the derivation cohort (44%) and 34 patients of the validation cohort (43%) had mechanical complications after ASD surgery. AUCs of the SRS-Schwab classification, GAP score, age-adjusted alignment goals, and GAPB were 0.532 (95% confidence interval [CI], 0.463-0.602), 0.798 (95% CI, 0.720-0.877), 0.568 (95% CI, 0.495-0.641), and 0.885 (95% CI 0.828-0.941), respectively.
CONCLUSIONS


The GAPB system, which includes BMI and BMD, showed improved predictability for predicting mechanical complications compared to the GAP score. Given these results, surgeons should keep in mind the importance of bone quality and BMI as well as proportional alignment.",2020,"The GAPB system, which includes BMI and BMD, showed improved predictability for predicting mechanical complications compared to the GAP score.","['Between January 2009 and December 2016, 203 consecutive patients with ASD underwent corrective fusion of more than 4 levels and were followed up for more than 2 years', 'After Adult Spinal Deformity Surgery', 'SAMPLE', 'elderly population with ASD', 'adult spinal deformity (ASD) surgery']",[],"['Global Alignment and Proportion (GAP) score', 'Mechanical Complications', 'body mass index (BMI) and bone mineral density (BMD', 'mechanical complications', 'predictability of GAP score', 'Modified Global Alignment and Proportion Scoring With Body Mass Index and Bone Mineral Density (GAPB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0575157', 'cui_str': 'Deformity of spine (finding)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",203.0,0.0687465,"The GAPB system, which includes BMI and BMD, showed improved predictability for predicting mechanical complications compared to the GAP score.","[{'ForeName': 'Sung Hyun', 'Initials': 'SH', 'LastName': 'Noh', 'Affiliation': 'Department of Neurosurgery, National Health Insurance Service Ilsan Hospital, Goyang, Korea; Department of Neurosurgery, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yoon', 'Initials': 'Y', 'LastName': 'Ha', 'Affiliation': 'Department of Neurosurgery, Spine and Spinal Cord Institute, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Obeid', 'Affiliation': 'Orthopedic Spinal Surgery Unit 1, Pellegrin Hospital, Place Amélie Raba-Léon, Bordeaux Cedex 33076, France.'}, {'ForeName': 'Jeong Yoon', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Neurosurgery, Spine and Spinal Cord Institute, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung Uk', 'Initials': 'SU', 'LastName': 'Kuh', 'Affiliation': 'Department of Neurosurgery, Spine and Spinal Cord Institute, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dong Kyu', 'Initials': 'DK', 'LastName': 'Chin', 'Affiliation': 'Department of Neurosurgery, Spine and Spinal Cord Institute, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Keun Su', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Spine and Spinal Cord Institute, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yong Eun', 'Initials': 'YE', 'LastName': 'Cho', 'Affiliation': 'Department of Neurosurgery, Spine and Spinal Cord Institute, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hye Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung Hyun', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Spine and Spinal Cord Institute, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. Electronic address: NSKHK@yuhs.ac.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2019.11.006']
3440,30556428,Pilot RCT of a social media parenting intervention for postpartum mothers with depression symptoms.,"Objective : This pilot study describes the adaptation of a parenting group intervention for social media, and examines the feasibility, acceptability and initial outcomes of the adapted intervention for mothers with postpartum depression symptoms.  Background : Postpartum depression can negatively affect parenting and the parent-infant relationship. Mothers with postpartum depression symptoms experience barriers to access in-person parenting interventions.  Methods : A small, randomised controlled trial was conducted with an adapted parenting intervention delivered via social media (Facebook) or in-person for mothers who screened positive for depression in paediatric clinics. Parenting sense of competence, depression symptoms and intervention attendance and satisfaction were assessed. Twenty-four mothers (mean age 26 years; predominantly African American with limited economic resources) participated in the study.  Results : Linear regressions showed that the social media group had significantly improved parenting competence and decreased depression severity when compared to the in-person group. Attendance in the social media group was high (83%), but extremely poor in the in-person group (3%). The mothers rated the intervention positively and the majority of the mothers participated by posting comments on the group page on social media.  Conclusion : The findings suggest the feasibility and benefit of delivering a parenting intervention through social media for postpartum mothers with high levels of depression symptoms.",2019,Linear regressions showed that the social media group had significantly improved parenting competence and decreased depression severity when compared to the in-person group.,"['Mothers with postpartum depression symptoms experience barriers to access in-person parenting interventions', 'Twenty-four mothers (mean age 26\xa0years; predominantly African American with limited economic resources) participated in the study', 'postpartum mothers with depression symptoms', 'mothers who screened positive for depression in paediatric clinics', 'postpartum mothers with high levels of depression symptoms', 'mothers with postpartum depression symptoms']","['social media parenting intervention', 'parenting intervention through social media', ' ', 'adapted parenting intervention delivered via social media (Facebook) or in-person']","['depression severity', 'Attendance', 'parenting competence', 'Parenting sense of competence, depression symptoms and intervention attendance and satisfaction']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]","[{'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0760381,Linear regressions showed that the social media group had significantly improved parenting competence and decreased depression severity when compared to the in-person group.,"[{'ForeName': 'Rhonda C', 'Initials': 'RC', 'LastName': 'Boyd', 'Affiliation': ""a Department of Child and Adolescent Psychiatry and Behavioral Sciences , The Children's Hospital of Philadelphia , Philadelphia , PA , USA.""}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Price', 'Affiliation': ""b Policylab: Center to Bridge Research Practice, & Policy , The Children's Hospital of Philadelphia, Roberts Center for Pediatric Research , Philadelphia , PA , USA.""}, {'ForeName': 'Marjie', 'Initials': 'M', 'LastName': 'Mogul', 'Affiliation': 'c Research Department , Maternity Care Coalition , Philadelphia , PA , USA.'}, {'ForeName': 'Tweety', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': ""d Children's Research Center , University of Illinois , Champaign , IL , USA.""}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Guevara', 'Affiliation': ""b Policylab: Center to Bridge Research Practice, & Policy , The Children's Hospital of Philadelphia, Roberts Center for Pediatric Research , Philadelphia , PA , USA.""}]",Journal of reproductive and infant psychology,['10.1080/02646838.2018.1556788']
3441,31227662,Efficacy of prefabricated carbon-composite ankle foot orthoses for children with unilateral spastic cerebral palsy exhibiting a drop foot pattern.,"PURPOSE


This study aims to evaluate the effectiveness of a prefabricated carbon-composite ankle foot orthoses (c-AFOs) on gait parameters in children with unilateral spastic cerebral palsy (USCP) exhibiting a drop foot pattern.
METHODS


Sixteen ambulatory children with USCP and a drop foot pattern were included (mean age: 9 years; gross motor function classification system: I = 14, II = 2) and three-dimensional gait analysis was applied under randomly assigned conditions (barefoot; shoe; c-AFO). Kinematics, kinetics, time-distance parameters and gait indices were investigated.
RESULTS


Effects on the drop foot pattern were investigated while the children walked in shoes only. The shoes already increased the maximum ankle dorsiflexion in swing (p= 0.004) and initiated more knee flexion during single support (p⩽ 0.013). Compared to shoe walking, the c-AFO led to additional benefits regarding further ankle dorsiflexion during swing (p⩽ 0.001) and initial contact (p< 0.001), ankle movement during loading response (p= 0.002), improved the sole angle during initial contact (p< 0.001) and during mid stance (p= 0.015). Plantarflexion and ankle power generation during push-off decreased when wearing the c-AFO (p⩽ 0.008).
CONCLUSION


Investigated c-AFOs are beneficial for improving drop foot patterns in children with USCP. Significant effects on pathological barefoot pattern were already achieved with the child's regular shoes. This could be considered in clinical decision processes. In comparison to shoe walking, c-AFO additionally improved foot clearance and normalized initial heel contact. The third rocker deteriorates with the c-AFO. Since kinematics improved with the orthoses during swing and early stance phase, c-AFOs might reduce tripping and falling caused by a drop foot during long distance walking.",2019,The shoes already increased the maximum ankle dorsiflexion in swing (p= 0.004) and initiated more knee flexion during single support (p⩽ 0.013).,"['Sixteen ambulatory children with USCP and a drop foot pattern were included (mean age: 9 years; gross motor function classification system: I = 14, II = 2) and three-dimensional gait analysis', 'children with unilateral spastic cerebral palsy (USCP) exhibiting a drop foot pattern', 'children with USCP', 'children with unilateral spastic cerebral palsy exhibiting a drop foot pattern']","['prefabricated carbon-composite ankle foot orthoses', 'prefabricated carbon-composite ankle foot orthoses (c-AFOs']","['knee flexion', 'foot clearance and normalized initial heel contact', 'Plantarflexion and ankle power generation', 'Kinematics, kinetics, time-distance parameters and gait indices', 'pathological barefoot pattern', 'ankle movement during loading response', 'maximum ankle dorsiflexion in swing', 'gait parameters', 'sole angle during initial contact']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0558820', 'cui_str': 'Gait Analysis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1283250', 'cui_str': 'Foot Orthotic Devices'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0277844', 'cui_str': 'Barefoot walking (finding)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}]",16.0,0.0470836,The shoes already increased the maximum ankle dorsiflexion in swing (p= 0.004) and initiated more knee flexion during single support (p⩽ 0.013).,"[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Altschuck', 'Affiliation': 'School of Medicine, Social Pediatrics, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bauer', 'Affiliation': 'kbo-Kinderzentrum München, Munich, Germany.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Nehring', 'Affiliation': 'School of Medicine, Social Pediatrics, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Böhm', 'Affiliation': 'Behandlungszentrum Aschau, Aschau im Chiemgau, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Jakobeit', 'Affiliation': 'kbo-Kinderzentrum München, Munich, Germany.'}, {'ForeName': 'A Sebastian', 'Initials': 'AS', 'LastName': 'Schröder', 'Affiliation': ""Department of Pediatric Neurology and Developmental Medicine, Hauner Children's Hospital, Ludwig-Maximilians-University Munich, Munich, Germany.""}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Mall', 'Affiliation': 'School of Medicine, Social Pediatrics, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Nikolai H', 'Initials': 'NH', 'LastName': 'Jung', 'Affiliation': 'School of Medicine, Social Pediatrics, Technical University of Munich, Munich, Germany.'}]",Journal of pediatric rehabilitation medicine,['10.3233/PRM-170524']
3442,31525489,Peer mentorship to reduce suicide attempts among high-risk adults (PREVAIL): Rationale and design of a randomized controlled effectiveness-implementation trial.,"RATIONALE


Novel approaches to suicide prevention are needed to address increasing rates of suicide deaths. Research suggests that interventions led by certified Peer Specialists may improve suicide protective factors such as hope and connectedness; however, the effectiveness of a Peer Specialist intervention for reducing suicidal thoughts or behaviors has not previously been tested empirically.
DESIGN


We describe the methodology of a randomized controlled hybrid effectiveness-implementation trial of a peer specialist intervention known as PREVAIL (Peers for Valued Living). The primary effectiveness aim is to determine whether the 3-month peer mentorship intervention compared to a minimally enhanced usual care condition reduces suicide attempts and suicidal ideation among adults at high risk for suicide who have been psychiatrically hospitalized. Secondary effectiveness outcomes include medically serious suicide attempts according to chart review and self-reported self-efficacy to avoid suicide. We also describe suicide risk management, supervision, and fidelity monitoring in the context of Peer Specialist providers and our methods for assessing implementation barriers and facilitators.
CONCLUSION


The PREVAIL trial will demonstrate novel methods for incorporating peer providers into a suicide prevention effectiveness trial with high-risk study participants. PREVAIL's hybrid effectiveness-implementation design aims to maximize the likelihood of rapid implementation in the community if shown to be effective.",2019,The primary effectiveness aim is to determine whether the 3-month peer mentorship intervention compared to a minimally enhanced usual care condition reduces suicide attempts and suicidal ideation among adults at high risk for suicide who have been psychiatrically hospitalized.,"['adults at high risk for suicide who have been psychiatrically hospitalized', 'high-risk adults (PREVAIL', 'Peers for Valued Living']","['Peer mentorship', 'peer mentorship intervention', 'Peer Specialist intervention', 'minimally enhanced usual care condition']",['medically serious suicide attempts according to chart review and self-reported self-efficacy to avoid suicide'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C3152857', 'cui_str': 'Prevail'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0541653', 'cui_str': 'Chart review'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",,0.132837,The primary effectiveness aim is to determine whether the 3-month peer mentorship intervention compared to a minimally enhanced usual care condition reduces suicide attempts and suicidal ideation among adults at high risk for suicide who have been psychiatrically hospitalized.,"[{'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Lapidos', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States. Electronic address: alapidos@umich.edu.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Abraham', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, United States; University of Detroit Mercy, Department of Psychology, Detroit, MI, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jagusch', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States; VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Garlick', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States; VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Walters', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States; VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, United States; Consulting for Statistics, Computing & Analytics Research, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Vega', 'Affiliation': 'Humannovations, Los Angeles, CA, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Damschroder', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Forman', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Ahmedani', 'Affiliation': 'Henry Ford Health System, Detroit, MI, United States.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'King', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Pfeiffer', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States; VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105850']
3443,31838879,Effects of a Group-Mediated Cognitive Behavioral Lifestyle Intervention on Select Social Cognitive Outcomes in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy.,"Objective . To compare the effects of a group-mediated cognitive behavioral (GMCB) exercise and dietary (EX+D) intervention with those of standard-of-care (SC) treatment on select social cognitive outcomes in prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT).  Methods . In the single-blind, 2-arm, randomized controlled Individualized Diet and Exercise Adherence-Pilot (IDEA-P) trial, 32 PCa patients (mean age = 66.2 years; SD = 7.8) undergoing ADT were randomly assigned to a 12-week EX+D intervention (n = 16) or SC treatment (n = 16). The exercise component of the personalized EX+D intervention integrated a combination of supervised resistance and aerobic exercise performed twice per week. The dietary component involved counseling and education to modify dietary intake and composition. Blinded assessments of social cognitive outcomes were obtained at baseline and 2-month and 3-month follow-up.  Results . Intent-to-treat analysis of covariance demonstrated that the EX+D intervention resulted in significantly greater improvements in scheduling ( P  < .05), coping ( P  < .01), and exercise self-efficacy ( P  < .05), and satisfaction with function ( P  < .01) at 3 months relative to SC. Results of partial correlation analysis also demonstrated that select social cognitive outcomes were significantly correlated with primary trial outcomes of mobility performance and exercise participation ( P  < .05) at 3-month follow-up.  Conclusions : The GMCB lifestyle intervention yielded more favorable improvements in relevant social cognitive outcomes relative to SC among PCa patients undergoing ADT. Additionally, more favorable social cognitive outcomes were associated with superior mobility performance and exercise participation following the independent maintenance phase of the EX+D intervention.",2019,The GMCB lifestyle intervention yielded more favorable improvements in relevant social cognitive outcomes relative to SC among PCa patients undergoing ADT.,"['32 PCa patients (mean age = 66.2 years; SD = 7.8) undergoing ADT', 'prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT', 'Prostate Cancer Patients']","['Undergoing Androgen Deprivation Therapy', 'Group-Mediated Cognitive Behavioral Lifestyle Intervention', 'group-mediated cognitive behavioral (GMCB) exercise and dietary (EX+D) intervention with those of standard-of-care (SC) treatment', 'EX+D intervention', 'personalized EX+D intervention integrated a combination of supervised resistance and aerobic exercise']","['mobility performance and exercise participation', 'exercise self-efficacy', 'superior mobility performance and exercise participation', 'satisfaction with function', 'favorable social cognitive outcomes', 'relevant social cognitive outcomes', 'social cognitive outcomes', 'Select Social Cognitive Outcomes', 'select social cognitive outcomes']","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0031843', 'cui_str': 'function'}]",32.0,0.0282053,The GMCB lifestyle intervention yielded more favorable improvements in relevant social cognitive outcomes relative to SC among PCa patients undergoing ADT.,"[{'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Focht', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Lucas', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Grainger', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Simpson', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Ciaran M', 'Initials': 'CM', 'LastName': 'Fairman', 'Affiliation': 'Edith Cowan University, Joondalup, Australia Capital Territory, Australia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Thomas-Ahner', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'Chaplow', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Victoria R', 'Initials': 'VR', 'LastName': 'DeScenza', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bowman', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Clinton', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}]",Integrative cancer therapies,['10.1177/1534735419893764']
3444,30785827,"Maintenance Defactinib Versus Placebo After First-Line Chemotherapy in Patients With Merlin-Stratified Pleural Mesothelioma: COMMAND-A Double-Blind, Randomized, Phase II Study.","PURPOSE


Inhibition of focal adhesion kinase has been shown to selectively kill mesothelioma cells that express low levels of moesin-ezrin-radixin-like protein (merlin). On this basis, we designed a randomized, phase II trial to investigate whether defactinib as maintenance therapy after standard first-line chemotherapy could improve progression-free survival (PFS) in patients with malignant pleural mesothelioma (MPM).
METHODS


This global, double-blind, randomized, placebo-controlled trial was conducted in patients with advanced MPM and disease control after at least four cycles of first-line chemotherapy. Patients were stratified for merlin and then randomly assigned (in a 1:1 fashion) to receive either oral defactinib or placebo until disease progression, unacceptable toxicity, or withdrawal occurred. The coprimary end points were PFS and overall survival (OS). Quality of life (QoL) was assessed using the Lung Cancer Symptom Scale for Mesothelioma tool.
RESULTS


Three hundred forty-four patients were randomly assigned to receive either defactinib (n = 173) or placebo (n = 171). The median PFS was 4.1 months (95% CI, 2.9 to 5.6 months) for defactinib versus 4.0 months (95% CI, 2.9 to 4.2 months) for placebo. The median OS was 12.7 months (95% CI, 9.1 to 21 months) for defactinib versus 13.6 months (95% CI, 9.6 to 21.2 months) for placebo (hazard ratio, 1.0; 95% CI, 0.7 to 1.4). Although shorter survival for both defactinib- and placebo-treated patients was observed, in the patients who had merlin-low MPM compared with the patients who had merlin-high MPM, there were no statistical differences in response rate, PFS, OS, or QoL between the treatment groups. The most common grade 3 or worse adverse events were nausea, diarrhea, fatigue, dyspnea, and decreased appetite.
CONCLUSION


Neither PFS nor OS was improved by defactinib after first-line chemotherapy in patients with merlin-low MPM. Defactinib cannot be recommended as maintenance therapy for advanced MPM.",2019,Neither PFS nor OS was improved by defactinib after first-line chemotherapy in patients with merlin-low MPM.,"['patients with merlin-low MPM', 'patients with malignant pleural mesothelioma (MPM', 'Patients', 'Three hundred forty-four patients', 'patients with advanced MPM and disease control after at least four cycles of first-line chemotherapy']","['defactinib', 'Placebo', 'oral defactinib or placebo', 'placebo']","['PFS and overall survival (OS', 'progression-free survival (PFS', 'nausea, diarrhea, fatigue, dyspnea, and decreased appetite', 'PFS nor OS', 'median OS', 'Quality of life (QoL', 'response rate, PFS, OS, or QoL', 'Lung Cancer Symptom Scale for Mesothelioma tool', 'median PFS', 'shorter survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0254121', 'cui_str': 'Falco columbarius (organism)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1742123', 'cui_str': '(11C)MPM'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura (disorder)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C3899400', 'cui_str': 'defactinib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0025500', 'cui_str': 'Mesothelioma'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",344.0,0.51284,Neither PFS nor OS was improved by defactinib after first-line chemotherapy in patients with merlin-low MPM.,"[{'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fennell', 'Affiliation': '1 University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Baas', 'Affiliation': '2 Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': '3 Wythenshawe Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Nowak', 'Affiliation': '4 University of Western Australia and Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gilligan', 'Affiliation': ""5 Cambridge University Hospitals National Health Service Foundation Trust, Addenbrooke's Hospital, Cambridge, United Kingdom.""}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakano', 'Affiliation': '6 Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Pachter', 'Affiliation': '7 Verastem, Boston, MA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Weaver', 'Affiliation': '7 Verastem, Boston, MA.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Scherpereel', 'Affiliation': '8 Calmette Hospital, Regional University Hospital of Lille, Lille Cedex, France.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Pavlakis', 'Affiliation': '9 Northern Cancer Institute, St Leonards, NSW, Australia.'}, {'ForeName': 'Jan P', 'Initials': 'JP', 'LastName': 'van Meerbeeck', 'Affiliation': '10 Universitair Ziekenuis, Antwerp, Belgium.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Cedrés', 'Affiliation': '11 Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Nolan', 'Affiliation': '12 University Hospital, Southampton, United Kingdom.'}, {'ForeName': 'Hedy', 'Initials': 'H', 'LastName': 'Kindler', 'Affiliation': '13 University of Chicago Medical Center, Chicago, IL.'}, {'ForeName': 'Joachim G J V', 'Initials': 'JGJV', 'LastName': 'Aerts', 'Affiliation': '14 Erasmus Medical College, Rotterdam, the Netherlands.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2018.79.0543']
3445,31378087,Intravitreal dexamethasone implant Ozurdex in the treatment of diabetic macular edema in patients not previously treated with any intravitreal drug: a prospective 12-month follow-up study.,"Objective:  To evaluate the mid-long-term efficacy and safety of the dexamethasone intravitreal (DEX) implant (Ozurdex 1 ) in naïve patients with diabetic macular edema (DME). Methods:  Prospective and single-center study conducted on consecutive patients with a diagnosis of DME, who received a DEX implant and were followed up for at least 12 months. The main outcomes measurements were the mean change in best corrected visual acuity (BCVA) and in foveal thickness (FT) as compared to the baseline values. Results:  Of the 84 screened patients 50 were included in the study. The BCVA significantly improved from 52.4 (20.4) letters at baseline to 62.6 (15.6), 61.2 (18.4), 61.6 (18.6), 60.6 (19.0), and 60.6 (18.8) at 2, 4, 6, 12 months and end of follow-up period, respectively (repeated measures ANOVA and the Greenhouse-Geisser correction;  p =  .0008). At the end of the follow-up period, a gain of BCVA of ≥5, ≥10, and ≥15 letters were observed in 26 (52.0%), 18 (36.0%), and 16 (32.0%) patients, respectively. The mean FT was significantly reduced from 446.0 (139.9) µm at baseline to 327.2 (103.6) at the end of follow-up (repeated measures ANOVA and the Greenhouse-Geisser correction;  p =  .0008). During the study follow-up, the patients receive a mean of 3.4 (2.9-3.9) implants. Of the 32 phakic eyes at baseline, 17 (53.1%) either developed new lens opacity or progression of an existing opacity. Conclusion:  In eyes with DME not previously treated with intravitreal drugs, DEX implants provide meaningful functional and anatomical benefits, and these results are sustained mid-long-term.",2019,"In eyes with DME not previously treated with intravitreal drugs, DEX implants provide meaningful functional and anatomical benefits, and these results are sustained mid-long-term.","['84 screened patients 50 were included in the study', 'consecutive patients with a diagnosis of DME, who received', 'naïve patients with diabetic macular edema (DME', 'patients not previously treated with any intravitreal drug']","['DEX implant', 'DEX', 'dexamethasone intravitreal (DEX) implant (Ozurdex', 'Intravitreal dexamethasone implant Ozurdex®']","['BCVA', 'new lens opacity or progression of an existing opacity', 'mean change in best corrected visual acuity (BCVA) and in foveal thickness (FT', 'diabetic macular edema', 'mean FT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1299681', 'cui_str': 'Intravitreal implant'}, {'cui': 'C2702456', 'cui_str': 'Ozurdex'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1510497', 'cui_str': 'Lens Opacities'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1265876', 'cui_str': 'Abnormally opaque structure (morphologic abnormality)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}]",,0.0317161,"In eyes with DME not previously treated with intravitreal drugs, DEX implants provide meaningful functional and anatomical benefits, and these results are sustained mid-long-term.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Menezo', 'Affiliation': 'Hospital Provincial de Castellón, Castellón, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': 'Hospital Comarcal de Vinaròs, Castellón, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Menezo', 'Affiliation': 'Institut Catalá de la Retina (ICR), Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Pascual', 'Affiliation': 'FISABIO-Oftalmología Médica (FOM), Valencia, Spain.'}]",Current medical research and opinion,['10.1080/03007995.2019.1652449']
3446,30528725,Paracervical Block as a Strategy to Reduce Postoperative Pain after Laparoscopic Hysterectomy: A Randomized Controlled Trial.,"STUDY OBJECTIVE


To determine if performing a paracervical block with .5% bupivacaine before laparoscopic hysterectomy reduces postoperative pain.
DESIGN


Double-blind randomized controlled trial (Canadian Task Force classification I).
SETTING


University-affiliated hospital.
PATIENTS


Women aged between 18 and 65 years scheduled to undergo total laparoscopic hysterectomy for benign indications.
INTERVENTIONS


Eligible patients were allocated to control or treatment groups using block randomization. Surgeon administered injection of either .9% NaCl or .5% bupivacaine into the cervical stroma at the 3 and 9 o'clock positions after general anesthesia was established. Pain was assessed using a visual analog scale with a range from 0 to 10 at 30 and 60 minutes after extubation.
MEASUREMENTS AND MAIN RESULTS


Forty-one patients met criteria for analysis. Based on randomization, 20 were allocated to the control arm and 21 to the treatment arm. We used Student t and Pearson χ 2  tests to ensure both groups were homogenous to age (46.5 vs 46, p = .87), body mass index (35 vs 32.7 kg/m 2 , p = .45), minutes of operating time (132.5 vs 119.7, p = .11), specimen weight (138.8 vs 160.6 g, p = .44), and history of cesarean section (p = .58). Pain scores at 30 minutes (5.7 vs 3.2, p = .01) and 60 minutes (5.9 vs 2.3, p <.001) were significantly lower in the treatment arm. We dichotomized results depending on whether patients had successful postoperative pain control, defined as an average pain score of 4 or less. The χ 2  test was used for comparison. Using this definition 25% of patients had successful pain control in the placebo group versus 71.4% in the treatment group. This was statistically significant (p = .003). Mean length of hospital stay (.65 vs .86 days, p = .44) was not statistically different.
CONCLUSION


Performing a paracervical block with .5% bupivacaine before laparoscopic hysterectomy significantly reduces immediate postoperative pain. (ClinicalTrials.gov no.: NCT03027661.).",2019,"Pain scores at 30 minutes (5.7 vs 3.2, p = .01) and 60 minutes (5.9 vs 2.3, p <.001) were significantly lower in the treatment arm.","['University-affiliated hospital', 'Women aged between 18 and 65 years scheduled to undergo total laparoscopic hysterectomy for benign indications', 'after Laparoscopic Hysterectomy']","['bupivacaine', 'Paracervical Block', 'paracervical block with .5% bupivacaine', 'placebo']","['Postoperative Pain', 'visual analog scale', 'immediate postoperative pain', 'Pain', 'specimen weight', 'Mean length of hospital stay', 'history of cesarean section', 'Pain scores', 'successful pain control', 'average pain score', 'body mass index']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0030401', 'cui_str': 'Paracervical Block'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0475172', 'cui_str': 'H/O: cesarean section'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.472878,"Pain scores at 30 minutes (5.7 vs 3.2, p = .01) and 60 minutes (5.9 vs 2.3, p <.001) were significantly lower in the treatment arm.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Radtke', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tennessee College of Medicine, Chattanooga, Tennessee (all authors). Electronic address: dr.radtke@gmail.com.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Boren', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tennessee College of Medicine, Chattanooga, Tennessee (all authors).'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Depasquale', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tennessee College of Medicine, Chattanooga, Tennessee (all authors).'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2018.12.001']
3447,32088668,Efficacy of Live Versus Recorded Harp Music in Reducing Preoperative Stress and Fear Related to Minor Surgery: A Pilot Study.,"Context


Before surgery, people can become concerned about risks that may arise, experiencing fear and stress. It is possible to implement nonpharmacological interventions to reduce fear and preoperative stress using expressive arts, including music therapy.
Objective


The aim of this study was to assess the effectiveness of live harp music and compare it with that of recorded harp music in reducing preoperative stress and fear and changes in blood pressure (BP) and heart rate (HR).
Design


The study was a pilot study, with a quasi-experimental design.
Setting


The study took place in a surgery unit's clinic, held weekly, in a teaching hospital in Milan, Italy.
Participants


Participants were 46 people undergoing day surgery, divided into 2 groups: 24 in the intervention group and 22 in the control group. No one dropped out of the study.
Intervention


The intervention group listened to live harp music and the control group listened to recorded harp music, immediately before a surgical intervention. The research team had defined a musical protocol based on the theoretical principles of harp therapy.
Outcome Measures


Before and after the musical intervention, the research team investigated each patient's level of fear and stress, using the same self-evaluation questionnaire (HR) and blood pressure (BP).
Results


Of the 46 participants, 46% were male, and 54% were female. Fear values were reduced significantly and in equal measure in the intervention (P = .001) and control (P = .0001) groups. The live harp music was more effective in reducing HR (P = .001) and diastolic BP (P = .007), than was recorded harp music, with P = .151 and P = .164, respectively. Based on the results, the research team determined that a randomized controlled trial (RCT) would require 90 patients for both the intervention and control groups.
Conclusions


Harp therapy brought benefits by significantly reducing fear and stress and HR and BP. It would be useful to perform a multicenter RCT to confirm these results.",2020,Fear values were reduced significantly and in equal measure in the intervention (P = .001) and control (P = .0001) groups.,"['46 participants, 46% were male, and 54% were female', 'Participants\n\n\nParticipants were 46 people undergoing day surgery, divided into 2 groups: 24 in the intervention group and 22 in the control group']","['intervention group listened to live harp music and the control group listened to recorded harp music, immediately before a surgical intervention', 'musical intervention', 'recorded harp music', 'live harp music', 'Live Versus Recorded Harp Music']","['diastolic BP', 'preoperative stress and fear and changes in blood pressure (BP) and heart rate (HR', 'Preoperative Stress and Fear Related to Minor Surgery', 'fear and stress and HR and BP', 'self-evaluation questionnaire (HR) and blood pressure (BP', 'Fear values']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0282046', 'cui_str': 'Surgery, Day'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0084084', 'cui_str': 'pleiotropin'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0038904', 'cui_str': 'Minor Surgery'}, {'cui': 'C2936633', 'cui_str': 'Self-Evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",46.0,0.0333677,Fear values were reduced significantly and in equal measure in the intervention (P = .001) and control (P = .0001) groups.,"[{'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Gelatti', 'Affiliation': ''}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Viganò', 'Affiliation': ''}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Borsani', 'Affiliation': ''}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Conistabile', 'Affiliation': ''}, {'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Bonetti', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
3448,32045409,"A multicomponent secondary school health promotion intervention and adolescent health: An extension of the SEHER cluster randomised controlled trial in Bihar, India.","BACKGROUND


Strengthening Evidence base on scHool-based intErventions for pRomoting adolescent health (SEHER) is a multicomponent, whole-school health promotion intervention delivered by a lay counsellor or a teacher in government-run secondary schools in Bihar, India. The objective of this study is to examine the effects of the intervention after two years of follow-up and to evaluate the consistency of the findings observed over time.
METHODS AND FINDINGS


We conducted a cluster randomised trial in which 75 schools were randomised (1:1:1) to receive the SEHER intervention delivered by a lay counsellor (SEHER Mitra [SM]) or a teacher (Teacher as SEHER Mitra [TSM]), respectively, alongside a standardised, classroom-based life skills Adolescence Education Program (AEP), compared to AEP alone (control group). The trial design was a repeat cross-sectional study. Students enrolled in grade 9 (aged 13-15 years) in the 2015-2016 academic year were exposed to the intervention for two years and the outcome assessment was conducted at three time points─at baseline in June 2015; 8-months follow-up in March 2016, when the students were still in grade 9; and endpoint at 17-months follow-up in December 2016 (when the students were in grade 10), the results of which are presented in this paper. The primary outcome, school climate, was measured with the Beyond Blue School Climate Questionnaire (BBSCQ). Intervention effects were estimated using mixed-effects linear or logistic regression, including a random effect to adjust for within-school clustering, minimisation variables, baseline cluster-level score of the outcome, and sociodemographic characteristics. In total, 15,232 students participated in the 17-month survey. Compared with the control group, the participants in the SM intervention group reported improvements in school climate (adjusted mean difference [aMD] = 7.33; 95% CI: 6.60-8.06; p < 0.001) and most secondary outcomes (depression: aMD = -4.64; 95% CI: -5.83-3.45; p < 0.001; attitude towards gender equity: aMD = 1.02; 95% CI: 0.65-1.40; p < 0.001; frequency of bullying: aMD = -2.77; 95% CI: -3.40 to -2.14; p < 0.001; violence victimisation: odds ratio [OR] = 0.08; 95% CI: 0.04-0.14; p < 0.001; and violence perpetration: OR = 0.16; 95% CI: 0.09-0.29; p < 0.001). There was no evidence of an intervention effect in the TSM group compared with control group. The effects of the lay counsellor-delivered intervention were larger for most outcomes at 17-months follow-up compared with those at 8 months: school climate (effect size [ES; 95% CI] = 2.23 [1.97-2.50] versus 1.88 [1.44-2.32], p < 0.001); depression (ES [95% CI] = -1.19 [-1.56 to -0.82] versus -0.27 [-0.44 to -0.11], p < 0.001); attitude towards gender equity (ES [95% CI] = 0.53 [0.27-0.79] versus 0.23 [0.10-0.36], p < 0.001); bullying (ES [95% CI] = -2.22 [-2.84 to -1.60] versus -0.47 [-0.61 to -0.33], p < 0.001); violence victimisation (OR [95% CI] = 0.08 [0.04-0.14] versus 0.62 [0.46-0.84], p < 0.001); and violence perpetration (OR [95% CI] = 0.16 [0.09-0.29] versus 0.68 [0.48-0.96], p < 0.001), suggesting incremental benefits with an extended intervention. A limitation of the study is that 27% of baseline participants did not complete the 17-month outcome assessment.
CONCLUSIONS


The trial showed that the second-year outcomes were similar to the first-year outcomes, with no effect of the teacher-led intervention and larger benefits on school climate and adolescent health accruing from extending lay counsellor-delivered intervention.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02907125.",2020,The effects of the lay counsellor-delivered intervention were larger for most outcomes at 17-months follow-up compared with those at 8 months: school climate (effect size [ES; 95% CI] =,"['A\xa0multicomponent secondary school health promotion intervention and adolescent health', '15,232 students participated in the 17-month survey', '75 schools', 'Students enrolled in grade 9 (aged 13-15 years) in the 2015-2016 academic year']","['TSM', 'SM intervention', 'SEHER intervention delivered by a lay counsellor (SEHER Mitra [SM]) or a teacher (Teacher as SEHER Mitra']","['school climate and adolescent health', 'school climate, was measured with the Beyond Blue School Climate Questionnaire (BBSCQ', 'school climate', 'violence perpetration', 'violence victimisation']","[{'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C1456722', 'cui_str': 'Teen Health'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C1456722', 'cui_str': 'Teen Health'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042693', 'cui_str': 'Violence'}]",15232.0,0.238933,The effects of the lay counsellor-delivered intervention were larger for most outcomes at 17-months follow-up compared with those at 8 months: school climate (effect size [ES; 95% CI] =,"[{'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Shinde', 'Affiliation': 'Sangath, Porvorim, Goa, India.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Prachi', 'Initials': 'P', 'LastName': 'Khandeparkar', 'Affiliation': 'Sangath, Porvorim, Goa, India.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Sangath, Porvorim, Goa, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Sangath, Porvorim, Goa, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Sangath, Porvorim, Goa, India.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ross', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Patton', 'Affiliation': ""Murdoch Children's Research Institute, University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Sangath, Porvorim, Goa, India.'}]",PLoS medicine,['10.1371/journal.pmed.1003021']
3449,31327652,"Immunogenicity of the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered concomitantly with the meningococcal serogroup B (4CMenB) vaccine in infants: A post-hoc analysis in a phase 3b, randomised, controlled trial.","BACKGROUND


No data are currently available on immunogenicity of higher-valent pneumococcal conjugate vaccines when co-administered with a 4-component meningococcal serogroup B vaccine (4CMenB).
METHODS


Post-hoc analysis of pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) immunogenicity when co-administered with 4CMenB (2 + 1 schedule) and/or a CRM-conjugated meningococcal serogroup C vaccine (MenC-CRM) in a trial assessing 4CMenB reduced schedules and co-administration with MenC-CRM (NCT01339923). Infants were randomized to receive 4CMenB and MenC-CRM (Group 1) or MenC-CRM (Group 2) at 3, 5, and 12 months (M) of age. Both groups received PHiD-CV (3 + 1 schedule) as part of the Brazilian national immunisation programme at 3 M, 5 M, 7 M, and 12 M of age. Antibody responses were assessed pre-vaccination, 1 M post-dose 2, pre-booster, and 1 M post-booster.
RESULTS


Anti-pneumococcal antibody responses were in similar ranges in the two study groups.
CONCLUSIONS


4CMenB co-administration did not seem to impact antibody responses to PHiD-CV in infants.",2019,"RESULTS


Anti-pneumococcal antibody responses were in similar ranges in the two study groups.
",['infants'],"['CRM-conjugated meningococcal serogroup C vaccine (MenC-CRM', 'MenC-CRM', '4CMenB and MenC-CRM (Group 1) or MenC-CRM', 'PHiD-CV', 'pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV', 'pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) immunogenicity when co-administered with 4CMenB (2\u202f+\u202f1 schedule', 'meningococcal serogroup B (4CMenB) vaccine']","['Antibody responses', 'Immunogenicity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0138826', 'cui_str': 'surface-exposed lipoprotein D, Haemophilus influenzae'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",,0.1851,"RESULTS


Anti-pneumococcal antibody responses were in similar ranges in the two study groups.
","[{'ForeName': 'Marco Aurelio P', 'Initials': 'MAP', 'LastName': 'Safadi', 'Affiliation': 'Santa Casa de São Paulo School of Medical Sciences and CDEC, São Paulo, Brazil. Electronic address: masafadi@uol.com.br.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Martinon-Torres', 'Affiliation': 'Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela, Spain; Genetics, Vaccines and Pediatrics Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago, University of Santiago de Compostela, Spain. Electronic address: federico.martinon.torres@sergas.es.'}, {'ForeName': 'Lily Yin', 'Initials': 'LY', 'LastName': 'Weckx', 'Affiliation': 'Federal University of Sao Paulo, Brazil. Electronic address: lily.crie@huhsp.org.br.'}, {'ForeName': 'Edson Duarte', 'Initials': 'ED', 'LastName': 'Moreira', 'Affiliation': 'CPEC - Associação Obras Sociais Irma Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Brazil. Electronic address: edson@bahia.fiocruz.br.'}, {'ForeName': 'Eduardo Jorge', 'Initials': 'EJ', 'LastName': 'da Fonseca Lima', 'Affiliation': 'CPEC - Instituto de Medicina Integral Professor Fernando Figueira, Boa Vista Recife, PE, Brazil. Electronic address: eduardojorge@imip.org.br.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Willemsen', 'Affiliation': 'Plus100 B.V. c/o Biostatistics, GSK, Amsterdam, the Netherlands. Electronic address: arnold.x.willemsen@gsk.com.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Toneatto', 'Affiliation': 'GSK, Siena, Italy. Electronic address: daniela.x.toneatto@gsk.com.'}, {'ForeName': 'Md Ahsan', 'Initials': 'MA', 'LastName': 'Habib', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: ahsan.m.habib@gsk.com.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Borys', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: dorota.d.borys@gsk.com.'}]",Vaccine,['10.1016/j.vaccine.2019.07.021']
3450,32078815,"Comparison of shortened mosaic HIV-1 vaccine schedules: a randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) and a preclinical study in rhesus monkeys (NHP 17-22).","BACKGROUND


Current efficacy studies of a mosaic HIV-1 prophylactic vaccine require four vaccination visits over one year, which is a complex regimen that could prove challenging for vaccine delivery at the community level, both for recipients and clinics. In this study, we evaluated the safety, tolerability, and immunogenicity of shorter, simpler regimens of trivalent Ad26.Mos.HIV expressing mosaic HIV-1 Env/Gag/Pol antigens combined with aluminium phosphate-adjuvanted clade C gp140 protein.
METHODS


We did this randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) at Beth Israel Deaconess Medical Center in Boston, MA, USA. We included healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement. We randomly assigned participants via a computer-generated randomisation schedule and interactive web response system to one of three study groups (1:1:1) testing different regimens of trivalent Ad26.Mos.HIV (5 × 10 10  viral particles per 0·5 mL) combined with 250 μg adjuvanted clade C gp140 protein. They were then assigned to treatment or placebo subgroups (5:1) within each of the three main groups. Participants and investigators were masked to treatment allocation until the end of the follow-up period. Group 1 received Ad26.Mos.HIV alone at weeks 0 and 12 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 24 and 48. Group 2 received Ad26.Mos.HIV plus adjuvanted gp140 at weeks 0, 12, and 24. Group 3 received Ad26.Mos.HIV alone at week 0 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 8 and 24. Participants in the control group received 0·5 mL of 0·9% saline. All study interventions were administered intramuscularly. The primary endpoints were Env-specific binding antibody responses at weeks 28, 52, and 72 and safety and tolerability of the vaccine regimens for 28 days after the injection. All participants who received at least one vaccine dose or placebo were included in the safety analysis; immunogenicity was analysed using the per-protocol population. The IPCAVD010/HPX1002 trial is registered with ClinicalTrials.gov, NCT02685020. We also did a parallel preclinical study in rhesus monkeys to test the protective efficacy of the shortened group 3 regimen.
FINDINGS


Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study vaccine or placebo, ten to each vaccine group and two to the corresponding placebo group. 30 (83%) participants completed the full study, and six (17%) discontinued it prematurely because of loss to follow-up, withdrawal of consent, investigator decision, and an unrelated death from a motor vehicle accident. The two shortened regimens elicited comparable antibody titres against autologous clade C Env at peak immunity to the longer, 12-month regimen: geometric mean titre (GMT) 41 007 (95% CI 17 959-93 636) for group 2 and 49 243 (29 346-82 630) for group 3 at week 28 compared with 44 590 (19 345-102 781) for group 1 at week 52). Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72. Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses were detected in all groups. All vaccine regimens were well tolerated. Mild-to-moderate pain or tenderness at the injection site was the most commonly reported solicited local adverse event, reported by 28 vaccine recipients (93%) and two placebo recipients (33%). Grade 3 solicited systemic adverse events were reported by eight (27%) vaccine recipients and no placebo recipients; the most commonly reported grade 3 systemic symptoms were fatigue, myalgia, and chills. The shortened group 3 regimen induced comparable peak immune responses in 30 rhesus monkeys as in humans and resulted in an 83% (95% CI 38·7-95, p=0·004 log-rank test) reduction in per-exposure acquisition risk after six intrarectal challenges with SHIV-SF162P3 at week 54, more than 6 months after final vaccination.
INTERPRETATION


Short, 6-month regimens of a mosaic HIV-1 prophylactic vaccine elicited robust HIV-specific immune responses that were similar to responses elicited by a longer, 12-month schedule. Preclinical data showed partial protective efficacy of one of the short vaccine regimens in rhesus monkeys. Further clinical studies are required to test the suitability of the shortened vaccine regimens in humans. Such shortened regimens would be valuable to increase vaccine delivery at the community level, particularly in resource-limited settings.
FUNDING


Ragon Institute (Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard University; Cambridge, MA, USA) and Janssen Vaccines & Prevention (Leiden, Netherlands).",2020,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"['HIV (5', 'rhesus monkeys (NHP 17-22', 'All participants who received at least one vaccine dose or', 'healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement', 'HIV expressing mosaic HIV-1', 'Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study', 'rhesus monkeys']","['placebo', '0·5 mL of 0·9% saline', 'aluminium phosphate-adjuvanted clade C gp140 protein', 'vaccine or placebo']","['Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses', 'Mild-to-moderate pain or tenderness', 'tolerated', 'Grade 3 solicited systemic adverse events', 'grade 3 systemic symptoms were fatigue, myalgia, and chills', 'safety, tolerability, and immunogenicity', 'partial protective efficacy', 'Env-specific binding antibody responses', 'peak immune responses', 'safety and tolerability', 'Antibody responses', 'protective efficacy', 'safety analysis; immunogenicity']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439750', 'cui_str': 'Mosaic (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0051519', 'cui_str': 'aluminium phosphate'}, {'cui': 'C0061830', 'cui_str': 'GP140'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020859', 'cui_str': 'IgG3'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",36.0,0.574721,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wegmann', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'C Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Ludo', 'Initials': 'L', 'LastName': 'Lavreys', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Howe', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Darla', 'Initials': 'D', 'LastName': 'Quijada', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Esther A', 'Initials': 'EA', 'LastName': 'Bondzie', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hendriks', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Nijs', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Truyers', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Tolboom', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Zahn', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30001-1']
3451,32078096,Intracoronary compared with intravenous bolus tirofiban on the microvascular obstruction in patients with STEMI undergoing PCI: a cardiac MR study.,"To investigate the potential effect of intracoronary administration of the glycoprotein IIb/IIIa inhibitor tirofiban on the microvascular obstruction (MVO) assessed by cardiac magnetic resonance (CMR) imaging compared to the intravenous route in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI). Two hundred eight patients were randomized into two groups (tirofiban i.v. and tirofiban i.c.). CMR was completed within 3-7 days after ST-segment-elevation myocardial infarction. One hundred thirty-two patients had a follow-up CMR at 6 months after discharge. The primary end point was the CMR measurements including myocardium strain, myocardial perfusion index, final infarct size, prevalence and extent of MVO, and the change of left ventricular end-diastolic volume (LVEDV) at six months follow-up. The second endpoint was major adverse cardiovascular events (composite of all-cause death, nonfatal reinfarction and congestive heart failure) in one year. The MVO prevalence and extent [56% versus 36%, p = 0.004; 2.08 (IQR: 1.18-5.07) g versus 1.68 (IQR: 0.30-3.28) g, p = 0.041] showed a significant difference between the intravenous and intracoronary groups. Global left ventricular peak longitudinal strain was significantly different in intracoronary groups compared to intravenous groups, - 12.5 [IQR: - 13.4 to - 10.9] versus - 12.3 [IQR: - 13.4 to - 10.4], respectively (P = 0.042). Infarcted myocardial perfusion index was significantly different in intracoronary groups compared to intravenous groups, 0.11 [IQR: 0.08 to 0.15] versus 0.09 [IQR: 0.07 to 0.14], respectively (P = 0.026). Intracoronary tirofiban was associated with a higher change in LVEDV compared with intravenous group (- 10.2% [IQR: - 13.7% to - 2.6%] versus 1.3% [IQR: - 5.6% to 6.1%], p < 0.001). Intracoronary tirofiban application showed no benefit on the occurrence of major adverse cardiovascular events during follow-up compared to intravenous administration. This CMR study in ST-segment-elevation myocardial infarction patients showed a benefit in MVO and left ventricular remodeling for intracoronary tirofiban administration compared to intravenous administration in patients undergoing PCI.",2020,"The MVO prevalence and extent [56% versus 36%, p = 0.004; 2.08 (IQR: 1.18-5.07)","['patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI', 'patients with STEMI undergoing PCI', 'Two hundred eight patients', 'patients undergoing PCI']","['Intracoronary tirofiban', 'glycoprotein IIb/IIIa inhibitor tirofiban', 'intracoronary tirofiban', 'intravenous bolus tirofiban', 'Intracoronary', 'tirofiban i.v. and tirofiban', 'cardiac magnetic resonance (CMR) imaging']","['microvascular obstruction', 'CMR', 'microvascular obstruction (MVO', 'major adverse cardiovascular events (composite of all-cause death, nonfatal reinfarction and congestive heart failure', 'Global left ventricular peak longitudinal strain', 'CMR measurements including myocardium strain, myocardial perfusion index, final infarct size, prevalence and extent of MVO, and the change of left ventricular end-diastolic volume (LVEDV', 'occurrence of major adverse cardiovascular events', 'LVEDV', 'Infarcted myocardial perfusion index', 'MVO prevalence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027061', 'cui_str': 'Muscle, Cardiac'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",208.0,0.0251666,"The MVO prevalence and extent [56% versus 36%, p = 0.004; 2.08 (IQR: 1.18-5.07)","[{'ForeName': 'Quanmei', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China.""}, {'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China.""}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China.""}, {'ForeName': 'Tongtong', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Duan', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Jiake', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Zongyu', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Yundi', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Zhaoqing', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China. houyang_1973@sina.com.""}]",The international journal of cardiovascular imaging,['10.1007/s10554-020-01800-0']
3452,32078337,Reducing training frequency from 3 or 4 sessions/week to 2 sessions/week does not attenuate improvements in maximal aerobic capacity with reduced-exertion high-intensity interval training (REHIT).,"In the present randomised-controlled trial we investigated the effect of reduced-exertion high-intensity interval training (REHIT) training frequency (2, 3, or 4 sessions/week for 6 weeks) on maximal aerobic capacity in 42 inactive individuals (13 women; mean ± SD age: 25 ± 5 years, maximal aerobic capacity: 35 ± 5 mL·kg -1 ·min -1 ). Changes in maximal aerobic capacity were not significantly different between the 3 groups (2 sessions/week: +10.2%; 3 sessions/week: +8.1%; 4 sessions per week: +7.3%). In conclusion, a training frequency of 2 sessions/week is sufficient for REHIT to improve maximal aerobic capacity.  Novelty  We demonstrate that reducing REHIT training frequency from 3 or 4 to 2 sessions/week does not attenuate improvements in the key health marker of maximal aerobic capacity.",2020,Changes in V̇O2max were not significantly different between the three groups (2 sessions/week: +10.2%; 3 sessions/week: +8.1%; 4 sessions per week: +7.3%).,"['42 inactive individuals (13 women; mean±SD age: 25±5 y, V̇O2max: 35±5 mL·kg-1·min-1']",['REHIT training frequency'],"['maximal aerobic capacity with reduced-exertion high-intensity interval training (REHIT', 'maximal aerobic capacity (V̇O2max', 'Changes in V̇O2max', 'Novelty']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",42.0,0.0158426,Changes in V̇O2max were not significantly different between the three groups (2 sessions/week: +10.2%; 3 sessions/week: +8.1%; 4 sessions per week: +7.3%).,"[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Thomas', 'Affiliation': 'School of Sport & Exercise Science, University of Worcester, Worcester, WR2 6AJ, UK.'}, {'ForeName': 'Preeyaphorn', 'Initials': 'P', 'LastName': 'Songsorn', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, FK9 4LA, UK.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Gorman', 'Affiliation': 'Sport and Exercise Sciences Research Institute, Ulster University, BT37 0QB, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Brackenridge', 'Affiliation': 'Sport and Exercise Sciences Research Institute, Ulster University, BT37 0QB, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Cullen', 'Affiliation': 'School of Sport & Exercise Science, University of Worcester, Worcester, WR2 6AJ, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Fitzpatrick', 'Affiliation': 'Sport and Exercise Sciences Research Institute, Ulster University, BT37 0QB, UK.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Metcalfe', 'Affiliation': 'Applied Sports Science Technology and Medicine Research Centre (A-STEM), Swansea University, Swansea, SA1 8EN, UK.'}, {'ForeName': 'Niels B J', 'Initials': 'NBJ', 'LastName': 'Vollaard', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, FK9 4LA, UK.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0750']
3453,31301919,Randomized study of immune responses to two Tdap vaccines among adolescents primed with DTaP and comparison with results among adolescents primed with DTwP.,"BACKGROUND


It has been reported that persons primed with acellular (DTaP) pertussis vaccines have reduced duration of pertussis protection compared with those primed with whole-cell (DTwP) vaccines. However, due to the rapid transition to acellular vaccines, studies attempting directly to compare protection among DTaP-primed vs DTwP-primed individuals are subject to confounding by age and other limitations of ecological studies. Using validated assay results and stored sera from multiple Tdap studies, we evaluated two licensed Tdap vaccines among DTaP-primed adolescents to allow comparison with results obtained in the same laboratory from earlier studies involving DTwP-primed adolescents.
METHODS


Participants 11-12 years of age who had received exactly 5 doses of DTaP vaccine prior to 7 years of age were randomly assigned in 2012 to receive one of two licensed Tdap vaccines. Serum specimens obtained pre- and post-vaccination were assayed for responses to the vaccines. Current results were then compared to results obtained in the same laboratory from prior randomized Tdap studies conducted among adolescents primed with DTwP or DTaP.
RESULTS


Both Tdap vaccines produced strong antibody responses to diphtheria and tetanus; responses to contained pertussis antigens were consistent with the differing levels of those antigens in each Tdap vaccine. However, postvaccination pertussis antibody responses were as much as 71% lower in these DTaP-primed adolescents compared with responses among DTwP-primed adolescents in a prior study of the same two Tdap vaccines. In contrast, results from the present study were similar to those seen in another study of Tdap among DTaP-primed adolescents.
DISCUSSION


Taken together, these results from randomized clinical trials provide direct evidence of reduced antibody responses to both licensed Tdap vaccines among adolescents primed with DTaP vaccine, compared with adolescents primed with DTwP vaccine. Clinical trial registry number: ClinicalTrials.gov, NCT01629589.",2019,Both Tdap vaccines produced strong antibody responses to diphtheria and tetanus; responses to contained pertussis antigens were consistent with the differing levels of those antigens in each Tdap vaccine.,"['adolescents primed with DTaP and comparison with results among adolescents primed with DTwP', 'adolescents primed with DTwP or DTaP.\nRESULTS', 'Participants 11-12\u202fyears of age who had received exactly 5 doses of DTaP vaccine prior to 7\u202fyears of age']","['DTaP vaccine', 'Tdap vaccines', 'DTwP vaccine']",['postvaccination pertussis antibody responses'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0535644', 'cui_str': 'DTaP Vaccines'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0535644', 'cui_str': 'DTaP Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1277100', 'cui_str': 'DPT Vaccine'}]","[{'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",,0.0207865,Both Tdap vaccines produced strong antibody responses to diphtheria and tetanus; responses to contained pertussis antigens were consistent with the differing levels of those antigens in each Tdap vaccine.,"[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Decker', 'Affiliation': 'US Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA; Department of Health Policy, Vanderbilt University School of Medicine, Nashville, TN, USA. Electronic address: td551@mdd1.org.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Greenberg', 'Affiliation': 'US Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA; Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Johnson', 'Affiliation': 'Global Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Vitali', 'Initials': 'V', 'LastName': 'Pool', 'Affiliation': 'US Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.07.015']
3454,31362537,Improving Teacher Practices With Children Under Five: Experimental Evidence From the Mississippi Buildings Blocks.,"BACKGROUND


The literature on the effects of teacher coaching in early childhood (EC) education programs is underdeveloped but emerging. Using the theory of action in professional development as our theoretical framework, we hypothesize that active coaching improves teaching methods and creates a more effective classroom environment for enhancing children's learning and skills.
OBJECTIVES


This study evaluates the effects of the Mississippi Building Blocks (MBB) program, an EC intervention with a strong emphasis on supervisor and coaching training.
RESEARCH DESIGN


We conduct a randomized controlled experiment in which data were collected at baseline, midpoint (Month 3), and postintervention (Month 6) in 24 preschool classrooms in Mississippi.
SUBJECTS


The experiment included 195 preschoolers, of which 95 were in classrooms led by teachers who received coaching (treatment) and 100 were in classrooms without coaching (control).
MEASURES


We measured child's emergent language and literacy, fine motor skills, gross motor skills, print language skills, problem-solving, math skills, and socioemotional development.
RESULTS


We find that MBB coaching led to substantial improvements in child outcomes relative to the control group, particularly in gross motor skills, print language skills, and socioemotional development. We also find some evidence that MBB coaching improved math skills, though these estimates are on the margin of statistical significance. Finally, a mediator analysis indicates that improvements in the classroom learning environment brought about by MBB coaching improved child outcomes.
CONCLUSIONS


Our findings suggest that an intensive form of classroom coaching for teachers leads to significant gains in child outcomes.",2019,"We find that MBB coaching led to substantial improvements in child outcomes relative to the control group, particularly in gross motor skills, print language skills, and socioemotional development.","['24 preschool classrooms in Mississippi', 'The experiment included 195 preschoolers, of which 95 were in classrooms led by teachers who received']","['teacher coaching', 'MBB coaching', 'coaching (treatment) and 100 were in classrooms without coaching (control', 'Mississippi Building Blocks (MBB) program, an EC intervention']","['gross motor skills, print language skills, and socioemotional development', ""child's emergent language and literacy, fine motor skills, gross motor skills, print language skills, problem-solving, math skills, and socioemotional development"", 'math skills']","[{'cui': 'C0026221', 'cui_str': 'Mississippi'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}]",95.0,0.0346993,"We find that MBB coaching led to substantial improvements in child outcomes relative to the control group, particularly in gross motor skills, print language skills, and socioemotional development.","[{'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Arteaga', 'Affiliation': 'Truman School of Public Affairs, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Thornburg', 'Affiliation': 'Center for Family and Policy Research, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Darolia', 'Affiliation': 'Truman School of Public Affairs, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hawks', 'Affiliation': 'Center for Family and Policy Research, University of Missouri, Columbia, MO, USA.'}]",Evaluation review,['10.1177/0193841X19865070']
3455,32060679,Efficacy of wheat hot pack (dry heat) and pottery hot pack (moist heat) on eyelid temperature and tissue blood flow in healthy eyes: a randomized control trial.,"PURPOSE


To investigate the eyelid temperature (Temp) and tissue blood flow (TBF) changes in healthy eyes using wheat hot pack (WHP) and pottery hot pack (PHP).
METHODS


A randomized, double-blind, within-subject crossover study design was conducted in a Thai tertiary care center. All healthy subjects received warm compress treatment with WHP and PHP. The subjects were randomized to receive the WHP or the PHP at the first sequence. Temp and TBF measurements were taken at baseline, and every 2 min during the 10-min application of the heated compresses, and every 2 min for a 10-min duration after the compresses were removed.
RESULTS


There were 29 females (96.7%) and 1 male. The mean (SD) age of the subjects was 33.17 (5.21) years. Two warm compresses were able to increase the surface lid Temp significantly from the baseline Temp at every time point of measurement and location. For the WHP application, the maximum surface Temp (SD) of the outer upper lid, outer lower lid, and inner lower lid were 40.07 (0.80) °C, 38.44 (0.91) °C, and 35.83 (0.71) °C, respectively (all P value < 0.001) and under the PHP application, the highest surface Temp (SD) were 40.63 (0.97) °C, 38.32 (1.27) °C, and 35.82 (0.71) °C, respectively (all P value < 0.001). Both WHP and PHP were able to increase TBF significantly with no adverse events and these effects can be sustained until 20 min.
CONCLUSIONS


The results of this study suggest the potential of using these warm compresses for meibomian gland dysfunction. Further clinical research is needed.",2020,"Both WHP and PHP were able to increase TBF significantly with no adverse events and these effects can be sustained until 20 min.
","['All healthy subjects received', 'Thai tertiary care center', '29 females (96.7%) and 1 male', 'healthy eyes', 'healthy eyes using']","['warm compress treatment with WHP and PHP', 'wheat hot pack (dry heat) and pottery hot pack (moist heat', 'WHP', 'wheat hot pack (WHP) and pottery hot pack (PHP']","['eyelid temperature and tissue blood flow', 'surface lid Temp', 'TBF', 'Temp and TBF measurements', 'eyelid temperature (Temp) and tissue blood flow (TBF) changes']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0332260', 'cui_str': 'Compressing (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}]","[{'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",29.0,0.0334943,"Both WHP and PHP were able to increase TBF significantly with no adverse events and these effects can be sustained until 20 min.
","[{'ForeName': 'Thidarat', 'Initials': 'T', 'LastName': 'Leeungurasatien', 'Affiliation': 'Glaucoma Division, Department of Ophthalmology, Faculty of Medicine, Chiang Mai University, 110 Intavarorot Road, Tambon Sripoom, Amphur Muang, Chiang Mai, 50200, Thailand. tleeungu@gmail.com.'}, {'ForeName': 'Aatit', 'Initials': 'A', 'LastName': 'Paungmali', 'Affiliation': 'Neuro-Musculoskeletal Pain and Research Unit, Department of Physical Therapy, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Apichat', 'Initials': 'A', 'LastName': 'Tantraworasin', 'Affiliation': 'General Thoracic Surgery Division, Department of Surgery, and Clinical Epidemiology and Clinical Statistic Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",International ophthalmology,['10.1007/s10792-020-01300-z']
3456,31278808,Treatment for human visceral leishmaniasis: a cost-effectiveness analysis for Brazil.,"OBJECTIVE


To estimate the cost-effectiveness of strategies for the treatment of VL in Brazil.
METHODS


Cost-effectiveness study comparing three therapeutic options: meglumine antimoniate (MA), liposomal amphotericin B (LAMB) and a combination of LAMB plus MA (LAMB plus MA), from public health system and societal perspectives. An analytical decision-making model was used to compare strategies for the following outcomes: early therapeutic failure avoided at 30 days, days of hospitalisation avoided and VL cure at 180 days. The efficacy and safety parameters of the drugs came from a randomised, open-label trial and the cost data came from a cost-of-illness study, both carried out in Brazil.
RESULTS


For all outcomes analysed, the LAMB strategy was more effective. The MA strategy was inferior to the LAMB plus MA strategy for the outcomes early therapeutic failure avoided and cure. When only LAMB and MA were compared from a societal perspective, a cost of US$ 278.56 was estimated for each additional early therapeutic failure avoided, a cost of US$ 26.88 for each additional day of hospitalisation avoided and a cost of US$ 89.88 for each additional case of cured VL, for the LAMB strategy vs. MA.
CONCLUSION


In Brazil, the LAMB strategy proved to be cost-effective for treating VL, considering a GDP per capita as the willingness-to-pay threshold, for all of the outcomes analysed in comparison to MA.",2019,"An analytical decision-making model was used to compare strategies for the following outcomes: early therapeutic failure avoided at 30 days, days of hospitalisation avoided and VL cure at 180 days.",['human visceral leishmaniasis'],"['LAMB plus MA (LAMB plus MA', 'meglumine antimoniate (MA), liposomal amphotericin B (LAMB']",['efficacy and safety parameters'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0023290', 'cui_str': 'Black Fever'}]","[{'cui': 'C0452875', 'cui_str': 'Lamb - meat (substance)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1096768', 'cui_str': 'meglumine antimoniate'}, {'cui': 'C1145701', 'cui_str': 'amphotericin B liposomal'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0309565,"An analytical decision-making model was used to compare strategies for the following outcomes: early therapeutic failure avoided at 30 days, days of hospitalisation avoided and VL cure at 180 days.","[{'ForeName': 'Isis Polianna Silva Ferreira', 'Initials': 'IPSF', 'LastName': 'de Carvalho', 'Affiliation': 'Centre for Tropical Medicine, University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Henry Maia', 'Initials': 'HM', 'LastName': 'Peixoto', 'Affiliation': 'Centre for Tropical Medicine, University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Gustavo Adolfo Sierra', 'Initials': 'GAS', 'LastName': 'Romero', 'Affiliation': 'Centre for Tropical Medicine, University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Maria Regina Fernandes', 'Initials': 'MRF', 'LastName': 'de Oliveira', 'Affiliation': 'Centre for Tropical Medicine, University of Brasilia, Brasilia, Brazil.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13284']
3457,31367931,"Firearm-related behaviors following firearm injury: changes in ownership, carrying and storage.","Individuals who sustain nonfatal gunshot wound (GSW) injuries are at substantially increased risk of subsequent firearm injury. There is a dearth of literature examining what, if any, firearm-related behavior changes occur among adults as a result of GSW injuries. Using survey data on firearm-related behaviors from an ongoing randomized controlled trial, we sought to describe changes in reported firearm-related behaviors among GSW patients following their injury. Our results suggest that patients with a GSW, especially firearm owners, may change their firearm-related behaviors following injury, some by increasing firearm-related safety and others by increasing frequency of behaviors that may place them at increased risk of subsequent injury. This study highlights the need for further examination of firearm-related behavior change among GSW patients and development of interventions to promote firearm safety among this population.",2019,Individuals who sustain nonfatal gunshot wound (GSW) injuries are at substantially increased risk of subsequent firearm injury.,"['Individuals who sustain nonfatal gunshot wound (GSW) injuries', 'GSW patients following their injury']",[],[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0043252', 'cui_str': 'Gunshot wound (morphologic abnormality)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]",[],[],,0.0594926,Individuals who sustain nonfatal gunshot wound (GSW) injuries are at substantially increased risk of subsequent firearm injury.,"[{'ForeName': 'Vivian H', 'Initials': 'VH', 'LastName': 'Lyons', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, USA. vlyons@uw.edu.'}, {'ForeName': 'Frederick P', 'Initials': 'FP', 'LastName': 'Rivara', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Alice Ning-Xue', 'Initials': 'AN', 'LastName': 'Yan', 'Affiliation': 'Harborview Injury Prevention and Research Center, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Currier', 'Affiliation': 'Harborview Injury Prevention and Research Center, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Ballsmith', 'Affiliation': 'Harborview Injury Prevention and Research Center, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Haggerty', 'Affiliation': 'Harborview Injury Prevention and Research Center, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Whiteside', 'Affiliation': 'Harborview Injury Prevention and Research Center, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Floyd', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Anjum', 'Initials': 'A', 'LastName': 'Hajat', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rowhani-Rahbar', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00052-1']
3458,31370976,Effects of ascending buprenorphine doses on measures of experimental pain: A pilot study.,"BACKGROUND


Buprenorphine is widely used in the treatment of opioid use disorder and pain management. Little is known about the analgesic effects of high-dose sublingual buprenorphine, particularly in doses of >8 mg. The aim of this study was to examine the effect of ascending doses of buprenorphine upon acute pain measures in patients stabilized on buprenorphine as treatment for opioid dependence.
METHODS


The pilot study (n = 7) was a randomised, controlled, double-blind, double-dummy, within-subject crossover study examining cold-pressor threshold and tolerance testing under different buprenorphine dose conditions. Each participant attended three sessions to test the analgesic effect of buprenorphine in their usual dose (100%), 150% and 200% of their usual daily dose.
RESULTS


No significant effects of increased dose were seen on experimental pain measures. Expected physiological effects on pupil size and pulse were observed with increasing dose. No effect of buprenorphine condition was seen on subjective ratings of drug strength, or self-reported sedation, though lower ratings drug liking were seen with 150% and 200% conditions, and lower ratings of 'bad effects' and intoxication were reported with the 200% buprenorphine dose condition. No safety concerns with the 150 and 200% buprenorphine dose condition were observed.
DISCUSSION


This pilot study suggests that a ceiling effect on analgesia may be observed in people maintained on buprenorphine, though larger studies may confirm this finding. Clinical Trial Number: ACTRN12614001038684.",2019,"No effect of buprenorphine condition was seen on subjective ratings of drug strength, or self-reported sedation, though lower ratings drug liking were seen with 150% and 200% conditions, and lower ratings of 'bad effects' and intoxication were reported with the 200% buprenorphine dose condition.","['patients stabilized on', 'The pilot study (n\u202f=\u202f7']","['Buprenorphine', 'buprenorphine']","['experimental pain', 'subjective ratings of drug strength, or self-reported sedation', 'pupil size and pulse', 'experimental pain measures', ""lower ratings of 'bad effects' and intoxication"", 'acute pain measures', 'ratings drug liking']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}]",,0.138001,"No effect of buprenorphine condition was seen on subjective ratings of drug strength, or self-reported sedation, though lower ratings drug liking were seen with 150% and 200% conditions, and lower ratings of 'bad effects' and intoxication were reported with the 200% buprenorphine dose condition.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'Monash Addiction Research Centre, Monash University, Melbourne, Australia; National Drug and Alcohol Research Centre, UNSW Sydney, Randwick, Australia; Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia. Electronic address: Suzanne.nielsen@monash.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rivas', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Demirkol', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia; University of Sydney, Division Addiction Medicine, Faculty of Medicine and Health, Sydney, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network, Sydney, Australia.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.07.002']
3459,32064725,A randomized clinical trial on the acute therapeutic effect of TRPA1 and TRPM8 agonists in patients with oropharyngeal dysphagia.,"BACKGROUND


Oropharyngeal dysphagia (OD) treatment is moving away from compensatory strategies toward active treatments that improve swallowing function. The aim of this study was to assess the acute therapeutic effect of TRPA1/M8 agonists in improving swallowing function in OD patients.
METHODS


Fifty-eight patients with OD caused by aging, stroke, or neurodegenerative disease were included in a three-arm, quadruple-blind, randomized clinical trial (NCT02193438). Swallowing safety and efficacy and the kinematics of the swallow response were assessed by videofluoroscopy (VFS) during the swallow of 182 ± 2 mPa·s viscosity (nectar) boluses of a xanthan gum thickener supplemented with (a) 756.6 μmol/L cinnamaldehyde and 70 μmol/L zinc (CIN-Zn) (TRPA1 agonists), (b) 1.6 mmol/L citral (CIT) (TRPA1 agonist), or (c) 1.6 mmol/L citral and 1.3 mmol/L isopulegol (CIT-ISO) (TRPA1 and TRPM8 agonists). The effects on pharyngeal event-related potentials (ERP) were assessed by electroencephalography.
KEY RESULTS


TRPA1 stimulation with either CIN-Zn or CIT reduced time to laryngeal vestibule closure (CIN-Zn P = .002, CIT P = .023) and upper esophageal sphincter opening (CIN-Zn P = .007, CIT P = .035). In addition, CIN-Zn reduced the penetration-aspiration scale score (P = .009), increased the prevalence of safe swallows (P = .041), and reduced the latency of the P2 peak of the ERP. CIT-ISO had no positive effect on biomechanics or neurophysiology. No significant adverse events were observed.
CONCLUSIONS AND INFERENCES


TRPA1 stimulation with CIN-Zn or CIT improves the swallow response which, in the case of CIN-Zn, is associated with a significant improvement in cortical activation and safety of swallow. These results provide the basis for the development of new active treatments for OD using TRPA1 agonists.",2020,"In addition, CIN-Zn reduced the penetration-aspiration scale score (P = .009), increased the prevalence of safe swallows (P = .041), and reduced the latency of the P2 peak of the ERP.","['Fifty-eight patients with OD caused by aging, stroke, or neurodegenerative disease', 'patients with oropharyngeal dysphagia', 'OD patients']","['CIN-Zn or CIT', 'videofluoroscopy (VFS) during the swallow of 182\xa0±\xa02\xa0mPa·s viscosity (nectar) boluses of a xanthan gum thickener supplemented with (a) 756.6\xa0μmol/L cinnamaldehyde and 70\xa0μmol/L zinc (CIN-Zn) (TRPA1 agonists', 'TRPA1/M8 agonists', 'TRPA1 and TRPM8 agonists']","['cortical activation and safety of swallow', 'swallow response', 'latency of the P2 peak of the ERP', 'time to laryngeal vestibule closure', 'penetration-aspiration scale score', 'adverse events', 'swallowing function', 'upper esophageal sphincter opening', 'pharyngeal event-related potentials (ERP', 'Swallowing safety and efficacy and the kinematics of the swallow response', 'prevalence of safe swallows']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0524851', 'cui_str': 'Degenerative Neurologic Disorders'}, {'cui': 'C0267071', 'cui_str': 'Oropharyngeal Dysphagia'}]","[{'cui': 'C0607063', 'cui_str': 'serum P-component'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C4301986', 'cui_str': 'Viscosity (property) (qualifier value)'}, {'cui': 'C0078596', 'cui_str': 'xanthan gum'}, {'cui': 'C0055754', 'cui_str': 'cinnamaldehyde'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0337380', 'cui_str': 'Endoscopic retrograde pancreatography (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0225564', 'cui_str': 'Structure of vestibule of larynx'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1451819', 'cui_str': 'Upper Esophageal Sphincter'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0282171', 'cui_str': 'Potentials, Event-Related'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",58.0,0.0548621,"In addition, CIN-Zn reduced the penetration-aspiration scale score (P = .009), increased the prevalence of safe swallows (P = .041), and reduced the latency of the P2 peak of the ERP.","[{'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Tomsen', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Barcelona, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Alvarez-Berdugo', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Rofes', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Barcelona, Spain.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Ortega', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Barcelona, Spain.'}, {'ForeName': 'Viridiana', 'Initials': 'V', 'LastName': 'Arreola', 'Affiliation': 'Gastrointestinal Motility Laboratory, Hospital de Mataró, Consorci Sanitari del Maresme, Mataró, Spain.'}, {'ForeName': 'Weslania', 'Initials': 'W', 'LastName': 'Nascimento', 'Affiliation': 'Gastrointestinal Motility Laboratory, Hospital de Mataró, Consorci Sanitari del Maresme, Mataró, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Gastrointestinal Motility Laboratory, Hospital de Mataró, Consorci Sanitari del Maresme, Mataró, Spain.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cabib', 'Affiliation': 'Gastrointestinal Motility Laboratory, Hospital de Mataró, Consorci Sanitari del Maresme, Mataró, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Bolivar-Prados', 'Affiliation': 'Gastrointestinal Motility Laboratory, Hospital de Mataró, Consorci Sanitari del Maresme, Mataró, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Mundet', 'Affiliation': 'Gastrointestinal Motility Laboratory, Hospital de Mataró, Consorci Sanitari del Maresme, Mataró, Spain.'}, {'ForeName': 'Coline', 'Initials': 'C', 'LastName': 'Legrand', 'Affiliation': 'Nestlé Research, Lausanne, Switzerland.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Clavé', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Barcelona, Spain.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Michlig', 'Affiliation': 'Nestlé Research, Lausanne, Switzerland.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13821']
3460,31265147,Development of a group structured education programme to support safe exercise in people with Type 1 diabetes: the EXTOD education programme.,"AIM


To develop a structured education programme for individuals with Type 1 diabetes who are engaging in regular exercise.
METHOD


A multidisciplinary team of experts in supporting exercise and physical activity for people with Type 1 diabetes, alongside researchers with experience of developing self-management education, developed an exercise programme using the Medical Research Council framework. The programme was informed by a review of the evidence relating to Type 1 diabetes and exercise, the behaviour change literature (including the behaviour change taxonomy), and qualitative interviews with stakeholders. The programme and supporting resources were refined using an iterative process of testing, delivery and collecting feedback from participants and the wider development team.
RESULTS


The outcome of the intervention development was the design of a feasible and acceptable intervention for people with Type 1 diabetes to support safe exercise. The pilot allowed refinement of the intervention prior to testing in a two-site feasibility randomized controlled trial. Key findings from the pilot informed minor restructuring of the timetable (timings and order) and adaptation of supporting educational materials (participant handbook and teaching materials).
CONCLUSION


The 'EXercise in people with Type One Diabetes' (EXTOD) education programme has been developed using robust methodology for the generation of educational interventions. It now needs testing in a randomized controlled trial.",2020,"The programme and supporting resources were refined using an iterative process of testing, delivery and collecting feedback from participants and the wider development team.
","['individuals with Type 1 diabetes who are engaging in regular exercise', ""people with Type One Diabetes' (EXTOD) education programme"", 'people with Type 1 diabetes']","['structured education programme', 'education programme to support safe exercise']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],,0.0758452,"The programme and supporting resources were refined using an iterative process of testing, delivery and collecting feedback from participants and the wider development team.
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Narendran', 'Affiliation': 'Department of Diabetes, University Hospitals Birmingham NHS Foundation Trust, Birmingham.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Greenfield', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Troughton', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals Leicester, Leicester.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Doherty', 'Affiliation': 'Department of Psychological Medicine, York Teaching Hospitals NHS Foundation Trust, York.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Quann', 'Affiliation': 'Leicester Clinical Trials Unit, College of Life Sciences, University of Leicester, Leicester.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': 'Department of Diabetes, Taunton and Somerset NHS Foundation Trust, Taunton.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Litchfield', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Andrews', 'Affiliation': 'Department of Diabetes, Taunton and Somerset NHS Foundation Trust, Taunton.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14064']
3461,31944250,Effects of a Parent-Administered Exercise Program in the Neonatal Intensive Care Unit: Dose Does Matter-A Randomized Controlled Trial.,"BACKGROUND


Despite the risk of delayed motor development in infants born preterm, knowledge about interventions in the neonatal intensive care unitt (NICU) and the effects of dosing is sparse.
OBJECTIVE


The objectives of this study were to examine the effectiveness of a parent-administered exercise program in the NICU on motor outcome at 3 months corrected age (CA) and the effect of dosing on motor performance.
DESIGN


This was a randomized clinical trial.
SETTING


The study was conducted at 3 university hospitals in Tromsø, Trondheim, and Oslo, Norway.
PARTICIPANTS


A total of 153 infants with gestational age <32 weeks at birth were randomly assigned to intervention or control groups.
INTERVENTION


A 3-week parent-administered intervention designed to facilitate movements in preterm infants was performed in the NICU. Parents were asked to administer the intervention 10 minutes twice a day.
MEASUREMENTS


Test of Infant Motor Performance (TIMP) was used to assess short-term outcome at 3 months CA.
RESULTS


No significant difference in the TIMP z-score was found between intervention and control groups at follow-up 3 months CA, but a significant positive relationship was found between total intervention dose and TIMP z-scores. The adjusted odds of having a clinical z-score < 0 at 3 months CA was about 6 times higher for infants with less than median intervention time than for infants with a longer intervention time.
LIMITATIONS


The number of infants born before 28 weeks was small. A spillover effect in favor of the control group was possible. We do not know if the infants received physical therapy after discharge from the hospital.
CONCLUSIONS


There was no difference in motor performance between the intervention group and the control group at 3 months CA. However, an increased intervention dose was positively associated with improved motor outcome.",2020,"No significant difference in the TIMP z-score was found between intervention and control groups at follow-up 3 months CA, but a significant positive relationship was found between total intervention dose and TIMP z-scores.","['3 university hospitals in Tromsø, Trondheim, and Oslo, Norway', 'A total of 153 infants with gestational age < 32 weeks at birth', 'infants born preterm', 'Neonatal Intensive Care Unit']","['parent-administered exercise program', 'physical therapy', 'Patient-Administered Exercise Program']","['TIMP z-score', 'motor outcome', 'Test of Infant Motor Performance (TIMP', 'motor performance', 'total intervention dose and TIMP z-scores']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",153.0,0.132704,"No significant difference in the TIMP z-score was found between intervention and control groups at follow-up 3 months CA, but a significant positive relationship was found between total intervention dose and TIMP z-scores.","[{'ForeName': 'Gunn Kristin', 'Initials': 'GK', 'LastName': 'Øberg', 'Affiliation': 'Department of Health and Care Sciences, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway, PB 6050 Langnes, Tromsø, 9037 Norway; and Department of Clinical Therapeutic Services, University Hospital North Norway, Tromsø, Norway.'}, {'ForeName': 'Gay L', 'Initials': 'GL', 'LastName': 'Girolami', 'Affiliation': 'Department of Physical Therapy, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Suzann K', 'Initials': 'SK', 'LastName': 'Campbell', 'Affiliation': 'University of Illinois at Chicago.'}, {'ForeName': 'Tordis', 'Initials': 'T', 'LastName': 'Ustad', 'Affiliation': 'Department of Clinical Services, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Ivar', 'Initials': 'I', 'LastName': 'Heuch', 'Affiliation': 'Department of Mathematics, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bjarne K', 'Initials': 'BK', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Community Medicine, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway; and Centre for Sami Health Research, Department of Community Medicine, University of Tromsø, The Arctic University of Norway.'}, {'ForeName': 'Per Ivar', 'Initials': 'PI', 'LastName': 'Kaaresen', 'Affiliation': 'Pediatric and Adolescent Department, University Hospital North Norway; and Department of Clinical Medicine, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway.'}, {'ForeName': 'Vibeke Smith', 'Initials': 'VS', 'LastName': 'Aulie', 'Affiliation': 'Section of Physiotherapy, Oslo University Hospital, Ullevål, Oslo, Norway.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Health and Care Sciences, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway; and Department of Clinical Therapeutic Services, University Hospital North Norway.'}]",Physical therapy,['10.1093/ptj/pzaa014']
3462,31372757,"Transdermal estradiol for postpartum depression: results from a pilot randomized, double-blind, placebo-controlled study.","Postpartum depression (PPD) is a common complication following delivery, though evidence-based treatment options are limited. This study explores the feasibility and efficacy of outpatient PPD treatment with transdermal estradiol (TE). In a pilot, double-blind, placebo-controlled trial, women with PPD were randomized to receive transdermal 17β-estradiol (100 mcg/day) or placebo patch. Over 6 weeks, women completed weekly ratings on the Beck Depression Inventory (BDI), Edinburgh Postnatal Depression Scale (EPDS), and Hamilton Depression Scale (HAM-D). Primary outcome measures were treatment response (> 50% decrease from baseline BDI) and remission (BDI < 10) at 6 weeks, and secondary outcome measures included severity on all scales at weeks 3 and 6. Of 12 recruited women, 6 received TE and 6 received placebo. By week 6, 5 women receiving TE responded to treatment and 4 showed symptom remission, compared to 2 responders and 1 remitter in the placebo group. This difference was not significant (p = 0.24). In a mixed-model of BDI ratings, TE was associated with a 9.2 point decrease at 3 weeks (95%CI - 19.5 to + 1.0, p = 0.074) and a 10.5 point decrease at 6 weeks (95%CI - 21.0-0.0, p = 0.049) compared to placebo, though these differences did not survive multiple comparisons correction. Analogous effects were found for HAM-D but not EPDS scores. Interestingly, no significant difference in plasma estradiol levels existed between groups. We were unable to demonstrate a significant therapeutic benefit of TE compared with placebo in PPD. Although limited by under-recruitment and loss to follow-up, our results suggest TE is a feasible option for outpatient PPD management, with preliminary evidence (based on secondary outcomes) for efficacy. Therapeutic effects may be seen as early as 3 weeks and may not directly depend on peripheral measures of estradiol.",2020,"In a mixed-model of BDI ratings, TE was associated with a 9.2 point decrease at 3 weeks (95%CI - 19.5 to + 1.0, p = 0.074) and a 10.5 point decrease at 6 weeks (95%CI - 21.0-0.0, p = 0.049) compared to placebo, though these differences did not survive multiple comparisons correction.","['Of 12 recruited women, 6 received TE and 6 received', 'postpartum depression', 'women with PPD']","['Transdermal estradiol', 'placebo', 'placebo patch', 'transdermal 17β-estradiol', 'outpatient PPD treatment with transdermal estradiol (TE']","['plasma estradiol levels', 'Postpartum depression (PPD', 'symptom remission', 'treatment response (>\u200950% decrease from baseline BDI) and remission', 'Beck Depression Inventory (BDI), Edinburgh Postnatal Depression Scale (EPDS), and Hamilton Depression Scale (HAM-D']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1277973', 'cui_str': 'Plasma estradiol measurement'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}]",12.0,0.768545,"In a mixed-model of BDI ratings, TE was associated with a 9.2 point decrease at 3 weeks (95%CI - 19.5 to + 1.0, p = 0.074) and a 10.5 point decrease at 6 weeks (95%CI - 21.0-0.0, p = 0.049) compared to placebo, though these differences did not survive multiple comparisons correction.","[{'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Pedro E', 'Initials': 'PE', 'LastName': 'Martinez', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Xiaobai', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Biostatistics and Epidemiology, National Institutes of Health Clinical Center, Bethesda, MD, USA.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Schenkel', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lynnette K', 'Initials': 'LK', 'LastName': 'Nieman', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Rubinow', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Schmidt', 'Affiliation': 'Section on Behavioral Endocrinology, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. PeterSchmidt@mail.nih.gov.'}]",Archives of women's mental health,['10.1007/s00737-019-00991-3']
3463,32073955,Improvement in Patient-Reported Outcomes With Intensity-Modulated Radiotherapy (RT) Compared With Standard RT: A Report From the NRG Oncology RTOG 1203 Study.,"PURPOSE


In oncology trials, the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) is the standard tool for reporting adverse events (AEs), but it may underreport symptoms experienced by patients. This analysis of the NRG Oncology RTOG 1203 compared symptom reporting by patients and clinicians during radiotherapy (RT).
PATIENTS AND METHODS


Patients with cervical or endometrial cancer requiring postoperative RT were randomly assigned to standard 4-field RT or intensity-modulated RT (IMRT). Patients completed the 6-item patient-reported outcomes version of the CTCAE (PRO-CTCAE) for GI toxicity assessing abdominal pain, diarrhea, and fecal incontinence at various time points. Patients reported symptoms on a 5-point scale. Clinicians recorded these AEs as CTCAE grades 1 to 5. Clinician- and patient-reported AEs were compared using McNemar's test for rates > 0%.
RESULTS


Of 278 eligible patients, 234 consented and completed the PRO-CTCAE. Patients reported high-grade abdominal pain 19.1% ( P  < .0001), high-grade diarrhea 38.5% ( P  < .0001), and fecal incontinence 6.8% more frequently than clinicians. Similar effects were seen between grade ≥ 1 CTCAE toxicity and any-grade patient-reported toxicity. Between-arm comparison of patient-reported high-grade AEs revealed that at 5 weeks of RT, patients who received IMRT experienced fewer GI AEs than patients who received 4-field pelvic RT with regard to frequency of diarrhea (18.2% difference;  P  = .01), frequency of fecal incontinence (8.2% difference;  P  = .01), and interference of fecal incontinence (8.5% difference;  P  = .04).
CONCLUSION


Patient-reported AEs showed a reduction in symptoms with IMRT compared with standard RT, whereas clinician-reported AEs revealed no difference. Clinicians also underreported symptomatic GI AEs compared with patients. This suggests that patient-reported symptomatic AEs are important to assess in this disease setting.",2020,"Patients reported high-grade abdominal pain 19.1% ( P  < .0001), high-grade diarrhea 38.5% ( P  < .0001), and fecal incontinence 6.8% more frequently than clinicians.","['patients and clinicians during radiotherapy (RT', '278 eligible patients, 234 consented and completed the PRO-CTCAE', 'Patients with cervical or endometrial cancer requiring postoperative RT']","['Standard RT', 'Intensity-Modulated Radiotherapy (RT', 'IMRT', 'standard 4-field RT or intensity-modulated RT (IMRT']","['6-item patient-reported outcomes version of the CTCAE (PRO-CTCAE) for GI toxicity assessing abdominal pain, diarrhea, and fecal incontinence', 'interference of fecal incontinence', 'frequency of fecal incontinence', 'frequency of diarrhea', 'toxicity', 'high-grade abdominal pain', 'high-grade diarrhea', 'fecal incontinence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}]",278.0,0.168368,"Patients reported high-grade abdominal pain 19.1% ( P  < .0001), high-grade diarrhea 38.5% ( P  < .0001), and fecal incontinence 6.8% more frequently than clinicians.","[{'ForeName': 'Anamaria R', 'Initials': 'AR', 'LastName': 'Yeung', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Pugh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Klopp', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Gil', 'Affiliation': 'Summa Health System, Akron, OH.'}, {'ForeName': 'Lari', 'Initials': 'L', 'LastName': 'Wenzel', 'Affiliation': 'University of California Irvine, Irvine, CA.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Westin', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Gaffney', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Small', 'Affiliation': 'Loyola University Chicago, Chicago, IL.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Thompson', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Desiree E', 'Initials': 'DE', 'LastName': 'Doncals', 'Affiliation': 'Cooper Cancer Center, Summa Akron City Hospital, Akron, OH.'}, {'ForeName': 'Guilherme H C', 'Initials': 'GHC', 'LastName': 'Cantuaria', 'Affiliation': 'Northside Hospital, Atlanta, GA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Yaremko', 'Affiliation': 'London Regional Cancer Program, London, United Kingdom.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ""Pamela Youde Nethersole Eastern Hospital, Hong Kong, Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Vijayananda', 'Initials': 'V', 'LastName': 'Kundapur', 'Affiliation': 'Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Dasarahally S', 'Initials': 'DS', 'LastName': 'Mohan', 'Affiliation': 'Kaiser Permanente Cancer Treatment Center, South San Francisco, CA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Haas', 'Affiliation': 'Reading Hospital, Reading, PA.'}, {'ForeName': 'Yong Bae', 'Initials': 'YB', 'LastName': 'Kim', 'Affiliation': 'Severance Hospital, Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Ferguson', 'Affiliation': 'Georgia Regents University, Augusta, GA.'}, {'ForeName': 'Snehal', 'Initials': 'S', 'LastName': 'Deshmukh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Deborah W', 'Initials': 'DW', 'LastName': 'Bruner', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kachnic', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02381']
3464,32032355,The effect of assessing genetic risk of prostate cancer on the use of PSA tests in primary care: A cluster randomized controlled trial.,"BACKGROUND


Assessing genetic lifetime risk for prostate cancer has been proposed as a means of risk stratification to identify those for whom prostate-specific antigen (PSA) testing is likely to be most valuable. This project aimed to test the effect of introducing a genetic test for lifetime risk of prostate cancer in general practice on future PSA testing.
METHODS AND FINDINGS


We performed a cluster randomized controlled trial with randomization at the level of general practices (73 in each of two arms) in the Central Region (Region Midtjylland) of Denmark. In intervention practices, men were offered a genetic test (based on genotyping of 33 risk-associated single nucleotide polymorphisms) in addition to the standard PSA test that informed them about lifetime genetic risk of prostate cancer and distinguished between ""normal"" and ""high"" risk. The primary outcome was the proportion of men having a repeated PSA test within 2 years. A multilevel logistic regression model was used to test the association. After applying the exclusion criteria, 3,558 men were recruited in intervention practices, with 1,235 (34.7%) receiving the genetic test, and 4,242 men were recruited in control practices. Men with high genetic risk had a higher propensity for repeated PSA testing within 2 years than men with normal genetic risk (odds ratio [OR] = 8.94, p < 0.01). The study was conducted in routine practice and had some selection bias, which is evidenced by the relatively large proportion of younger and higher income participants taking the genetic test.
CONCLUSIONS


Providing general practitioners (GPs) with access to a genetic test to assess lifetime risk of prostate cancer did not reduce the overall number of future PSA tests. However, among men who had a genetic test, knowledge of genetic risk significantly influenced future PSA testing.
TRIAL REGISTRATION


This study is registered with ClinicalTrials.gov, number NCT01739062.",2020,"Men with high genetic risk had a higher propensity for repeated PSA testing within 2 years than men with normal genetic risk (odds ratio [OR] = 8.94, p < 0.01).","['Men with high genetic risk', '3,558 men were recruited in intervention practices, with 1,235 (34.7%) receiving the genetic test, and 4,242 men were recruited in control practices', 'primary care', 'general practices (73 in each of two arms) in the Central Region (Region Midtjylland) of Denmark']",[],['proportion of men having a repeated PSA test'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0679560', 'cui_str': 'Genetic Testing'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0454907', 'cui_str': 'Central region (geographic location)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]",[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]",4242.0,0.223805,"Men with high genetic risk had a higher propensity for repeated PSA testing within 2 years than men with normal genetic risk (odds ratio [OR] = 8.94, p < 0.01).","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Fredsøe', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Koetsenruyter', 'Affiliation': 'Research Unit for General Practice, The Research Centre for Cancer Diagnosis in Primary Care (Cap), Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vedsted', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Kirkegaard', 'Affiliation': 'Department of Public Health, Randers Regional Hospital, Randers, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Væth', 'Affiliation': 'Department of Public Health, Section of Biostatistics, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Torben F', 'Initials': 'TF', 'LastName': 'Ørntoft', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Karina D', 'Initials': 'KD', 'LastName': 'Sørensen', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Bro', 'Affiliation': 'Research Unit for General Practice, The Research Centre for Cancer Diagnosis in Primary Care (Cap), Aarhus University, Aarhus, Denmark.'}]",PLoS medicine,['10.1371/journal.pmed.1003033']
3465,31538948,Telemonitoring of Crohn's Disease and Ulcerative Colitis (TECCU): Cost-Effectiveness Analysis.,"BACKGROUND


Although electronic health interventions are considered safe and efficient, evidence regarding the cost-effectiveness of telemonitoring in inflammatory bowel disease is lacking.
OBJECTIVE


We aimed to evaluate the cost-effectiveness and cost-utility of the Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa (Telemonitoring of Crohn's Disease and Ulcerative Colitis [TECCU]) Web platform (G_TECCU intervention group) for telemonitoring complex inflammatory bowel disease, compared with standard care (G_control) and nurse-assisted telephone care (G_NT intervention group).
METHODS


We analyzed cost-effectiveness from a societal perspective by comparing the 3 follow-up methods used in a previous 24-week randomized controlled trial, conducted at a tertiary university hospital in Spain. Patients with inflammatory bowel disease who initiated immunosuppressants or biologic agents, or both, to control inflammatory activity were recruited consecutively. Data on the effects on disease activity (using clinical indexes) and quality-adjusted life-years (using the EuroQol 5 dimensions questionnaire) were collected. We calculated the costs of health care, equipment, and patients' productivity and social activity impairment. We compared the mean costs per patient, utilities, and bootstrapped differences.
RESULTS


We included 63 patients (21 patients per group). TECCU saved €1005 (US $1100) per additional patient in remission compared with G_control (95% CI €-13,518 to 3137; US $-14,798 to 3434), with a 79.96% probability of being more effective at lower costs. Compared with G_NT, TECCU saved €2250 (US $2463) per additional patient in remission (95% CI €-15,363 to 11,086; US $-16,817 to 12,135), and G_NT saved €538 (US $589) compared with G_control (95% CI €-6475 to 5303; US $-7088 to 5805). G_TECCU and G_NT showed an 84% and 67% probability, respectively, of producing a cost saving per additional quality-adjusted life-year (QALY) compared with G_control, considering those simulations that involved negative incremental QALYs as well.
CONCLUSIONS


There is a high probability that the TECCU Web platform is more cost-effective than standard and telephone care in the short term. Further research considering larger cohorts and longer time horizons is required.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (http://www. webcitation.org/746CRRtDN).",2019,"Compared with G_NT, TECCU saved €2250 (US $2463) per additional patient in remission (95% CI €-15,363 to 11,086; US $-16,817 to 12,135), and G_NT saved €538 (US $589) compared with G_control (95% CI €-6475 to 5303; US $-7088 to 5805).","['de la Enfermedad de Crohn y Colitis Ulcerosa', 'Patients with inflammatory bowel disease who initiated immunosuppressants or biologic agents, or both, to control inflammatory activity were recruited consecutively', '63 patients (21 patients per group', 'tertiary university hospital in Spain']","['Telemonitorización', 'G_TECCU and G_NT', 'TECCU Web platform', 'Web platform (G_TECCU intervention', 'standard care (G_control) and nurse-assisted telephone care (G_NT intervention group', 'TECCU', 'G_NT, TECCU']","['cost-effectiveness and cost-utility', 'mean costs per patient, utilities, and bootstrapped differences', ""costs of health care, equipment, and patients' productivity and social activity impairment"", 'disease activity (using clinical indexes) and quality-adjusted life-years']","[{'cui': 'C0010346', 'cui_str': 'Regional Enteritis'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressants'}, {'cui': 'C0005515', 'cui_str': 'Biological Agents'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0220824', 'cui_str': 'equipment'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",63.0,0.212745,"Compared with G_NT, TECCU saved €2250 (US $2463) per additional patient in remission (95% CI €-15,363 to 11,086; US $-16,817 to 12,135), and G_NT saved €538 (US $589) compared with G_control (95% CI €-6475 to 5303; US $-7088 to 5805).","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Del Hoyo', 'Affiliation': 'Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Nos', 'Affiliation': 'Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Bastida', 'Affiliation': 'Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Faubel', 'Affiliation': 'Physiotherapy Department, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Garrido-Marín', 'Affiliation': 'Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Valero-Pérez', 'Affiliation': 'Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bejar-Serrano', 'Affiliation': 'Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Aguas', 'Affiliation': 'Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain.'}]",Journal of medical Internet research,['10.2196/15505']
3466,31325110,Long-Term Effect of Immediate Versus Delayed Fingolimod Treatment in Young Adult Patients with Relapsing-Remitting Multiple Sclerosis: Pooled Analysis from the FREEDOMS/FREEDOMS II Trials.,"INTRODUCTION


Fingolimod has demonstrated clinical and MRI benefits versus placebo/interferon β-1a in young adults with multiple sclerosis (MS). Here we report the long-term effects of fingolimod 0.5 mg on clinical and MRI outcomes in young adults with MS aged ≤ 30 years followed up for up to 8 years (96 months).
METHODS


This post hoc analysis of pooled FREEDOMS/FREEDOMS II studies included patients who either received fingolimod 0.5 mg from randomization (immediate; N = 163) or switched from placebo to fingolimod at month (M) 24 (delayed; N = 147). The 6-month confirmed disability improvement [6m-CDI: based on Expanded Disability Status Scale (EDSS)], 6m-CDI-plus (6m-CDI+; EDSS, 9-Hole Peg Test, Timed 25-Foot Walk Test), 6-month confirmed disability progression (6m-CDP), time to EDSS score ≥ 4, annualized relapse rates (ARRs), new/newly enlarging T2 (neT2) lesions, and annual rate of brain volume loss (BVL) were analyzed from baseline to M24, M48, and M96. Cox regression and negative binomial regression models were used to analyze measured outcomes.
RESULTS


At baseline, more than two-thirds of young adult patients were treatment naïve, had more than two relapses in the previous 2 years, and EDSS score < 2. From M0 to M96, a significantly higher proportion of young adult patients in the immediate group (vs. delayed group) achieved 6m-CDI (58.2% vs. 30.5%, p = 0.0206) and 6m-CDI+ (70.6% vs. 42.3%, p = 0.0149); significantly fewer patients reached 6m-CDP (20.1% vs. 34.7%, p = 0.0058) and EDSS ≥ 4 (24.1% vs. 34.1%, p = 0.0041). Up to M96, young adults in the immediate versus delayed group had lower ARRs (0.16 vs. 0.38, p < 0.0001) and a higher proportion of patients were free of neT2 lesions at M48 (31.0% vs. 5.0%, p = 0.0011).
CONCLUSION


In young adult patients with MS, immediate versus delayed fingolimod treatment was associated with improved disease outcomes and greater long-term benefits in both disease activity and disability progression.
FUNDING


Novartis Pharma AG.",2019,"In young adult patients with MS, immediate versus delayed fingolimod treatment was associated with improved disease outcomes and greater long-term benefits in both disease activity and disability progression.
","['young adults with MS aged\u2009≤\u200930\xa0years followed up for up to 8\xa0years (96\xa0months', 'young adults with multiple sclerosis (MS', 'Young Adult Patients with Relapsing-Remitting Multiple Sclerosis', 'II studies included patients who either received']","['Immediate Versus Delayed Fingolimod Treatment', 'fingolimod', 'placebo/interferon β-1a', 'fingolimod 0.5\xa0mg from randomization (immediate; N\u2009=\u2009163) or switched from placebo']","['Expanded Disability Status Scale (EDSS)], 6m-CDI-plus (6m-CDI+; EDSS, 9-Hole', '6m-CDI', 'Peg Test, Timed 25-Foot Walk Test), 6-month confirmed disability progression (6m-CDP), time to EDSS score\u2009≥\u20094, annualized relapse rates (ARRs), new/newly enlarging T2 (neT2) lesions, and annual rate of brain volume loss (BVL', 'disease outcomes and greater long-term benefits in both disease activity and disability progression', 'lower ARRs', 'clinical and MRI outcomes']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C2938759', 'cui_str': 'fingolimod 0.5 MG'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0010724', 'cui_str': 'CDP'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0442800', 'cui_str': 'Enlarged (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",,0.0317428,"In young adult patients with MS, immediate versus delayed fingolimod treatment was associated with improved disease outcomes and greater long-term benefits in both disease activity and disability progression.
","[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Ghezzi', 'Affiliation': 'Centro Studi Sclerosi Multipla, Gallarate, Italy. angelo.ghezzi@asst-valleolona.it.'}, {'ForeName': 'Tanuja', 'Initials': 'T', 'LastName': 'Chitnis', 'Affiliation': 'Partners Pediatric Multiple Sclerosis Centre, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Annik', 'Initials': 'A', 'LastName': 'K-Laflamme', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Meinert', 'Affiliation': 'DATAMAP GmbH, Freiburg, Germany.'}, {'ForeName': 'Dieter A', 'Initials': 'DA', 'LastName': 'Häring', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pohl', 'Affiliation': ""Division of Neurology, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.""}]",Neurology and therapy,['10.1007/s40120-019-0146-z']
3467,31120518,Circulating Biomarkers of Testosterone's Anabolic Effects on Fat-Free Mass.,"BACKGROUND


Biomarkers that predict response to anabolic therapies could expedite the development of function promoting anabolic drugs. This study aimed to identify serum biomarkers that are responsive to testosterone administration and associated with increases in fat-free mass (FFM).
METHODS


Serum samples were obtained from the 5α-Reductase Trial, a randomized trial that compared the effects of graded doses of testosterone enanthate for 20-weeks in healthy men randomized to placebo or dutasteride (dual SRD5A inhibitor). Testosterone's effects on FFM or strength measures did not differ between placebo vs dutasteride groups. Accordingly, 54 subjects treated with testosterone plus placebo were included in the Discovery Cohort, and 48 randomized to dutasteride were included in the Validation Cohort. 1162 biomarkers were evaluated using pre-specified criteria.
RESULTS


In the Discovery Cohort, testosterone administration increased PRO-C3 and PRO-C6 levels in a dose- and concentration-dependent manner; increases in these biomarkers from baseline to week-12 were associated with changes in FFM from baseline to week-20 (PRO-C3: r2=0.437, p<0.001; PRO-C6: r2=0.434, p<0.001). Changes in PRO-C3 and PRO-C6 levels were significantly associated with changes in chest press strength (PRO-C3: r2=0.394, p<0.001; PRO-C6: r2=0.530, p<0.001). In the SOMAscan, changes in insulin-like growth factor binding protein-6 (IGFBP6) and Glypican 3 (GPC3) were associated with changes in total and free testosterone levels and FFM. These findings were replicated in the Validation Cohort.
CONCLUSION


PRO-C3, PRO-C6, IGFBP6 and GPC3 fulfilled the pre-specified criteria for biomarkers of testosterone-induced muscle anabolism: changes in these biomarkers were associated with changes in total and free testosterone concentrations and with testosterone-induced gains in FFM.",2019,"-C6 levels were significantly associated with changes in chest press strength (PRO-C3: r2=0.394, p<0.001; PRO-C6: r2=0.530, p<0.001).","['healthy men randomized to', '54 subjects treated with']","['testosterone plus placebo', 'Testosterone', 'placebo', 'dutasteride', 'testosterone enanthate', 'placebo or dutasteride (dual SRD5A inhibitor']","['PRO-C3 and PRO-C6 levels', 'chest press strength', 'PRO-C3 and PRO', 'fat-free mass (FFM', 'C6 levels', 'total and free testosterone levels and FFM', 'Fat-Free Mass', 'FFM or strength measures', 'insulin-like growth factor binding protein-6 (IGFBP6) and Glypican 3 (GPC3']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C0076189', 'cui_str': 'testosterone enanthate'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0071997', 'cui_str': 'C3 Precursor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443483', 'cui_str': 'Free testosterone (substance)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0169975', 'cui_str': 'Insulin-Like Growth Factor Binding Protein 6'}, {'cui': 'C0386983'}]",1162.0,0.0695954,"-C6 levels were significantly associated with changes in chest press strength (PRO-C3: r2=0.394, p<0.001; PRO-C6: r2=0.530, p<0.001).","[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Section of Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital-Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Guilherme V', 'Initials': 'GV', 'LastName': 'Rocha', 'Affiliation': 'Eli Lilly and Co., Indianapolis, IN, USA.'}, {'ForeName': 'Karol M', 'Initials': 'KM', 'LastName': 'Pencina', 'Affiliation': ""Section of Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital-Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cox', 'Affiliation': 'Eli Lilly and Co., Indianapolis, IN, USA.'}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Krishnan', 'Affiliation': 'Eli Lilly and Co., Indianapolis, IN, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Henriksen', 'Affiliation': 'Nordic Bioscience Biomarkers & Research, Dept. of Endocrinology, Herlev, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mitchell', 'Affiliation': 'Eli Lilly and Co., Indianapolis, IN, USA.'}, {'ForeName': 'Sean E', 'Initials': 'SE', 'LastName': 'Sissons', 'Affiliation': 'Eli Lilly and Co., Indianapolis, IN, USA.'}, {'ForeName': 'Zhuoying', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Section of Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital-Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Anders F', 'Initials': 'AF', 'LastName': 'Nedergaard', 'Affiliation': 'Nordic Bioscience Biomarkers & Research, Dept. of Endocrinology, Herlev, Denmark.'}, {'ForeName': 'Morten A', 'Initials': 'MA', 'LastName': 'Karsdal', 'Affiliation': 'Nordic Bioscience Biomarkers & Research, Dept. of Endocrinology, Herlev, Denmark.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Nordic Bioscience Biomarkers & Research, Dept. of Endocrinology, Herlev, Denmark.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Storer', 'Affiliation': ""Section of Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital-Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""Section of Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital-Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Section of Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital-Harvard Medical School, Boston, MA, USA.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00505']
3468,31999876,Effects of progressive aquatic resistance training on symptoms and quality of life in women with knee osteoarthritis: A secondary analysis.,"OBJECTIVE


To conduct a secondary analysis to study the effects, those 4 months of aquatic resistance training have on self-assessed symptoms and quality of life in post-menopausal women with mild knee osteoarthritis (OA), after the intervention and after a 12-month follow-up period.
METHODS


A total of 87 post-menopausal volunteer women, aged 60-68 years, with mild knee OA were recruited in a randomized, controlled, 4-month aquatic training trial (RCT) and randomly assigned to an intervention (n = 43) and a control (n = 44) group. The intervention group participated in 48 supervised aquatic resistance training sessions over 4 months while the control group maintained their usual level of physical activity. Additionally, 77 participants completed the 12-month post-intervention follow-up period. Self-assessed symptoms were estimated using the OA-specific Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and Health-related Quality of life (HRQoL) using the generic Short-form Health Survey (SF-36).
RESULTS


After 4 months of aquatic resistance training, there was a significant decrease in the stiffness dimension of WOMAC -8.5 mm (95% CI = -14.9 to -2.0, P = .006) in the training group compared to the controls. After the cessation of the training, this benefit was no longer observed during the 12-month follow-up. No between-group differences were observed in any of the SF-36 dimensions.
CONCLUSIONS


The results of this study show that participation in an intensive aquatic resistance training program did not have any short- or long-term impact on pain and physical function or quality of life in women with mild knee OA. However, a small short-term decrease in knee stiffness was observed.",2020,"No between-group differences were observed in any of the SF-36 dimensions.
","['women with knee osteoarthritis', 'women with mild knee OA', '87 postmenopausal volunteer women, aged 60-68 years, with mild knee OA', 'postmenopausal women with mild knee osteoarthritis (OA', '77 participants completed the 12-month post-intervention follow-up period']","['48 supervised aquatic resistance training sessions', 'aquatic training trial (RCT', 'progressive aquatic resistance training', 'aquatic resistance training']","['symptoms and quality of life', 'knee stiffness', 'stiffness dimension of WOMAC', 'self-assessed symptoms and quality of life', 'SF-36 dimensions', 'pain and physical function or quality of life', 'OA-specific Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and Health-related Quality of life (HRQoL']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",87.0,0.056066,"No between-group differences were observed in any of the SF-36 dimensions.
","[{'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Munukka', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Waller', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Arja', 'Initials': 'A', 'LastName': 'Häkkinen', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Miika T', 'Initials': 'MT', 'LastName': 'Nieminen', 'Affiliation': 'Research Unit of Medical Imaging, Physics and Technology, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Eveliina', 'Initials': 'E', 'LastName': 'Lammentausta', 'Affiliation': 'Department of Diagnostic Radiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Urho M', 'Initials': 'UM', 'LastName': 'Kujala', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Paloneva', 'Affiliation': 'Department of Surgery, Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Kiviranta', 'Affiliation': 'Department of Orthopaedics and Traumatology, University of Helsinki, and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Heinonen', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13630']
3469,31375422,"Correction of hypomagnesemia by dapagliflozin in patients with type 2 diabetes: A post hoc analysis of 10 randomized, placebo-controlled trials.","AIMS


Hypomagnesemia (serum magnesium [Mg] <0.74 mmol/L [<1.8 mg/dL]) is commonly observed in patients with type 2 diabetes (T2D). This study investigated the effect of treatment with dapagliflozin 10 mg on Mg concentrations in patients with T2D.
METHODS


In this post hoc analysis, we used pooled data from 10 placebo-controlled studies of dapagliflozin over 24 weeks of treatment in patients with T2D. We evaluated the change in Mg in patients receiving dapagliflozin vs. placebo overall, and in subgroups with baseline hypomagnesemia and normal/hypermagnesemia (≥0.74 mmol/L [≥1.8 mg/dL]). We determined the proportion of patients with baseline hypomagnesemia who achieved Mg ≥0.74 mmol/L (≥1.8 mg/dL).
RESULTS


A total of 4398 patients with T2D were included. The mean change from baseline to week 24 in Mg was significantly larger with dapagliflozin vs. placebo; difference, 0.06 mmol/L (95% confidence interval [CI]: 0.05, 0.06). The proportion of patients with Mg within the population reference range after 24 weeks of treatment was significantly higher with dapagliflozin vs. placebo; difference, 47.8% (95% CI: 41.4, 53.9). The proportion of patients displaying hypermagnesemia did not increase with dapagliflozin treatment.
CONCLUSIONS


Treatment with dapagliflozin 10 mg resulted in correction of Mg concentrations in patients with T2D and hypomagnesemia.",2019,"The proportion of patients with Mg within the population reference range after 24 weeks of treatment was significantly higher with dapagliflozin vs. placebo; difference, 47.8% (95% CI: 41.4, 53.9).","['patients with T2D.\nMETHODS', '4398 patients with T2D were included', 'patients with T2D and hypomagnesemia', 'patients with type 2 diabetes (T2D', 'patients with T2D', 'patients with baseline hypomagnesemia who achieved Mg', 'patients with type 2 diabetes']","['dapagliflozin vs. placebo', 'placebo', 'dapagliflozin', 'Hypomagnesemia (serum magnesium [Mg] <0.74\u202fmmol/L [<1.8\u202fmg/dL', 'hypomagnesemia by dapagliflozin']","['correction of Mg concentrations', 'baseline hypomagnesemia and normal/hypermagnesemia', 'proportion of patients displaying hypermagnesemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia (disorder)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia (disorder)'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum (procedure)'}, {'cui': 'C4517478', 'cui_str': '0.74 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia (disorder)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0151714', 'cui_str': 'Hypermagnesemia (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",4398.0,0.316952,"The proportion of patients with Mg within the population reference range after 24 weeks of treatment was significantly higher with dapagliflozin vs. placebo; difference, 47.8% (95% CI: 41.4, 53.9).","[{'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Toto', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: robert.toto@utsouthwestern.edu.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Goldenberg', 'Affiliation': 'LMC Diabetes & Endocrinology, Thornhill, ON, Canada.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Cain', 'Affiliation': 'Bogier Clinical and IT Solutions, Raleigh, NC, USA.'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefánsson', 'Affiliation': 'Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sartipy', 'Affiliation': 'Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Systems Biology Research Center, School of Bioscience, University of Skövde, Skövde, Sweden.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.06.007']
3470,31073087,"Effect of domiciliary oxygen therapy on exercise capacity and quality of life in patients with pulmonary arterial or chronic thromboembolic pulmonary hypertension: a randomised, placebo-controlled trial.","STUDY QUESTION


We investigated whether domiciliary oxygen therapy (DOXT) increases exercise capacity and quality of life in patients with pulmonary arterial or distal chronic thromboembolic pulmonary hypertension (PAH/CTEPH) presenting with mild resting hypoxaemia and exercise-induced oxygen desaturation.
MATERIALS AND METHODS


30 patients with PAH/CTEPH, mean±sd age 60±15 years, pulmonary artery pressure 39±11 mmHg, resting arterial oxygen saturation measured by pulse oximetry ( S   pO 2  ) ≥90%,  S   pO 2  drop during a 6-min walk test ≥4%, on pulmonary hypertension-targeted medication, were randomised in a double-blind crossover protocol to DOXT and placebo (ambient air) treatment, each over 5 weeks, at 3 L·min -1   via  nasal cannula overnight and when resting during the day. Treatment periods were separated by 2 weeks of washout. Co-primary outcomes were changes in 6-min walk distance (6MWD, breathing ambient air) and physical functioning scale of the 36-item short-form medical outcome questionnaire during treatment periods.
RESULTS


DOXT increased the 6MWD from baseline 478±113 m by a mean (95% CI) of 19 (6-32) m, and physical functioning from 52±29 by 4 (0-8) points. Corresponding changes with placebo were 1 (-11-13) m in 6MWD and -2 (-6-2) points in physical functioning. Between-treatment differences in changes were 6MWD 18 (1-35) m (p=0.042) and physical functioning 6 (1-11) points (p=0.029). DOXT significantly improved the New York Heart Association functional class  versus  placebo.
ANSWER TO THE QUESTION


This first randomised trial in PAH/CTEPH patients with exercise-induced hypoxaemia demonstrates that DOXT improves exercise capacity, quality of life and functional class. The results support large long-term randomised trials of DOXT in PAH/CTEPH.",2019,"Between-treatment differences in changes were 6MWD 18 m (1 to 35, p=0.042) and PF 6 points (1 to 11, p=0.029).","['patients with pulmonary arterial or chronic thromboembolic pulmonary hypertension', 'patients with pulmonary arterial or distal chronic thromboembolic pulmonary hypertension (PAH/CTEPH) presenting with mild resting hypoxemia and exercise-induced oxygen desaturation', '30 patients with PAH/CTEPH, mean age (±sd) 60±15']","['DOXT and placebo', 'domiciliary oxygen therapy (DOXT', 'placebo', 'DOXT', 'domiciliary oxygen therapy']","['6-min walk distance (6MWD, breathing ambient air) and physical functioning scale (PF) of the short form medical outcome questionnaire (SF-36', 'exercise capacity and quality of life', 'exercise capacity, quality of life and functional class']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363973', 'cui_str': 'Thromboembolic pulmonary hypertension (disorder)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0338047', 'cui_str': 'Domiciliary (environment)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",30.0,0.346332,"Between-treatment differences in changes were 6MWD 18 m (1 to 35, p=0.042) and PF 6 points (1 to 11, p=0.029).","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ulrich', 'Affiliation': 'University Hospital Zurich, Dept of Respiratory Medicine, Pulmonary Hypertension Unit, Zurich, Switzerland silvia.ulrich@usz.ch.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Saxer', 'Affiliation': 'University Hospital Zurich, Dept of Respiratory Medicine, Pulmonary Hypertension Unit, Zurich, Switzerland.'}, {'ForeName': 'Elisabeth D', 'Initials': 'ED', 'LastName': 'Hasler', 'Affiliation': 'University Hospital Zurich, Dept of Respiratory Medicine, Pulmonary Hypertension Unit, Zurich, Switzerland.'}, {'ForeName': 'Esther I', 'Initials': 'EI', 'LastName': 'Schwarz', 'Affiliation': 'University Hospital Zurich, Dept of Respiratory Medicine, Pulmonary Hypertension Unit, Zurich, Switzerland.'}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Schneider', 'Affiliation': 'University Hospital Zurich, Dept of Respiratory Medicine, Pulmonary Hypertension Unit, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Furian', 'Affiliation': 'University Hospital Zurich, Dept of Respiratory Medicine, Pulmonary Hypertension Unit, Zurich, Switzerland.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Bader', 'Affiliation': 'University Hospital Zurich, Dept of Respiratory Medicine, Pulmonary Hypertension Unit, Zurich, Switzerland.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Lichtblau', 'Affiliation': 'University Hospital Zurich, Dept of Respiratory Medicine, Pulmonary Hypertension Unit, Zurich, Switzerland.'}, {'ForeName': 'Konrad E', 'Initials': 'KE', 'LastName': 'Bloch', 'Affiliation': 'University Hospital Zurich, Dept of Respiratory Medicine, Pulmonary Hypertension Unit, Zurich, Switzerland.'}]",The European respiratory journal,['10.1183/13993003.002762019']
3471,32062791,Phase 3 Multicenter Study of Revusiran in Patients with Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with Cardiomyopathy (ENDEAVOUR).,"PURPOSE


The Phase 3 ENDEAVOUR study evaluated revusiran, an investigational RNA interference therapeutic targeting hepatic transthyretin (TTR) production, for treating cardiomyopathy caused by hereditary transthyretin-mediated (hATTR) amyloidosis.
METHODS


Patients with hATTR amyloidosis with cardiomyopathy were randomized 2:1 to receive subcutaneous daily revusiran 500 mg (n = 140) or placebo (n = 66) for 5 days over a week followed by weekly doses. Co-primary endpoints were 6-min walk test distance and serum TTR reduction.
RESULTS


Revusiran treatment was stopped after a median of 6.71 months; the study Sponsor prematurely discontinued dosing due to an observed mortality imbalance between treatment arms. Eighteen (12.9%) patients on revusiran and 2 (3.0%) on placebo died during the on-treatment period. Most deaths in both treatment arms were adjudicated as cardiovascular due to heart failure (HF), consistent with the natural history of the disease. A post hoc safety investigation of patients treated with revusiran found that, at baseline, a greater proportion of those who died were ≥ 75 years and showed clinical evidence of more advanced HF compared with those who were alive throughout treatment. Revusiran pharmacokinetic exposures and TTR lowering did not show meaningful differences between patients who died and who were alive. Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
CONCLUSIONS


Causes for the observed mortality imbalance associated with revusiran were thoroughly investigated and no clear causative mechanism could be identified. Although the results suggest similar progression of cardiac parameters in both treatment arms, a role for revusiran cannot be excluded.
CLINICAL TRIAL REGISTRATION


NCT02319005.",2020,"Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
","['Patients with hATTR amyloidosis with cardiomyopathy', 'Patients with Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with Cardiomyopathy (ENDEAVOUR']","['Revusiran', 'subcutaneous daily revusiran 500\xa0mg (n\u2009=\u2009140) or placebo']","['6-min walk test distance and serum TTR reduction', 'echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events', 'mortality imbalance', 'Revusiran pharmacokinetic exposures and TTR lowering']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]","[{'cui': 'C4505592', 'cui_str': 'revusiran'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4505592', 'cui_str': 'revusiran'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",,0.0976805,"Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
","[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Judge', 'Affiliation': 'Johns Hopkins Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Arnt V', 'Initials': 'AV', 'LastName': 'Kristen', 'Affiliation': 'Department of Cardiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Grogan', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mathew S', 'Initials': 'MS', 'LastName': 'Maurer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Rodney H', 'Initials': 'RH', 'LastName': 'Falk', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Gillmore', 'Affiliation': 'National Amyloidosis Centre, Division of Medicine, UCL Medical School Royal Free Hospital Rowland Hill Street, NW3 2PF, London, UK.'}, {'ForeName': 'Pushkal', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Akshay K', 'Initials': 'AK', 'LastName': 'Vaishnaw', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Harrop', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Karsten', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vest', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Hawkins', 'Affiliation': 'National Amyloidosis Centre, Division of Medicine, UCL Medical School Royal Free Hospital Rowland Hill Street, NW3 2PF, London, UK. p.hawkins@ucl.ac.uk.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-019-06919-4']
3472,32080862,Treprostinil Hydrogel Iontophoresis in Systemic Sclerosis-Related Digital Skin Ulcers: A Safety Study.,"Digital skin ulcers are a severe complication of systemic sclerosis. The first-line treatment is intravenous iloprost, but it induces dose-limiting adverse effects. Local administration of treprostinil through skin iontophoresis may be a safe alternative. We conducted a 2-stage, randomized, placebo-controlled single-ascending-dose study in healthy volunteers and patients with systemic sclerosis-related digital ulcer. We further explored the effect of the procedure on skin blood flux. In a first group of healthy subjects, treprostinil and placebo iontophoresis were performed at 3 locations (ie, 6 skin sites): the sole of the foot, the leg, and the fingers. We used a 1-mg/mL hydrogel of treprostinil. We then randomly treated systemic sclerosis-related digital ulcers in a 3:1 ratio of treprostinil or placebo. We used concentrations from 0.1 to 1 mg/mL. All adverse events were recorded and rated according to the Common Terminology Criteria for Adverse Events (CTCAE), whereas skin microvascular blood flux was recorded with laser speckle contrast imaging. Among the 12 healthy volunteers, we observed 60 local adverse effects: burns, skin pain, erythema, and pruritus, graded 1 or 2 on the 5-point CTCAE scale. Treprostinil iontophoresis significantly increased skin blood flux on the leg (AUC 0-4 h  at 88 460% ± 6436% versus 12 730% ± 3397% baseline flux.min respectively; P < .001) and on the sole of the foot (AUC 0-3 h  at 20 124% ± 6119% versus 3142% ± 3036% baseline flux.min, respectively; P = .018) with a trend on the finger. Among 5 patients with systemic sclerosis-related digital ulcer, 2 resolutive local adverse effects were reported. Iontophoresis of treprostinil hydrogel was safe in systemic sclerosis patients with digital ulcer.",2020,"Treprostinil iontophoresis significantly increased skin blood flux on the leg (AUC 0-4 h  at 88 460% ± 6436% versus 12 730% ± 3397% baseline flux.min respectively; P < .001) and on the sole of the foot (AUC 0-3 h  at 20 124% ± 6119% versus 3142% ± 3036% baseline flux.min, respectively; P = .018) with a trend on the finger.","['healthy volunteers and patients with systemic sclerosis-related digital ulcer', 'systemic sclerosis patients with digital ulcer', '5 patients with systemic sclerosis-related digital ulcer', '12 healthy volunteers', 'Systemic Sclerosis-Related Digital Skin', 'Ulcers']","['treprostinil', 'placebo', 'Treprostinil Hydrogel Iontophoresis', 'treprostinil hydrogel', 'treprostinil and placebo iontophoresis', 'treprostinil or placebo', 'Treprostinil iontophoresis', '1-mg/mL hydrogel of treprostinil']","['skin blood flux', 'Digital skin ulcers', 'skin microvascular blood flux', 'local adverse effects: burns, skin pain, erythema, and pruritus, graded 1 or 2 on the 5-point CTCAE scale']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036421', 'cui_str': 'Systemic Scleroderma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3267035', 'cui_str': 'Digital ulcer'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]","[{'cui': 'C1145760', 'cui_str': 'Treprostinil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0022024', 'cui_str': 'Iontophoresis'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0005768'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0037299', 'cui_str': 'Skin Ulcer'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0222045'}]",12.0,0.0330762,"Treprostinil iontophoresis significantly increased skin blood flux on the leg (AUC 0-4 h  at 88 460% ± 6436% versus 12 730% ± 3397% baseline flux.min respectively; P < .001) and on the sole of the foot (AUC 0-3 h  at 20 124% ± 6119% versus 3142% ± 3036% baseline flux.min, respectively; P = .018) with a trend on the finger.","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Guigui', 'Affiliation': 'Grenoble Alpes University Hospital, Clinical Pharmacology, Grenoble, France.'}, {'ForeName': 'Roseline', 'Initials': 'R', 'LastName': 'Mazet', 'Affiliation': 'Grenoble Alpes University Hospital, Pharmacy, Grenoble, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Blaise', 'Affiliation': 'Univ. Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Cracowski', 'Affiliation': 'Grenoble Alpes University Hospital, Clinical Pharmacology, Grenoble, France.'}, {'ForeName': 'Myrtille', 'Initials': 'M', 'LastName': 'Beau-Guillaumot', 'Affiliation': 'Grenoble Alpes University Hospital, Clinical Pharmacology, Grenoble, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Kotzki', 'Affiliation': 'Univ. Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Roustit', 'Affiliation': 'Grenoble Alpes University Hospital, Clinical Pharmacology, Grenoble, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Cracowski', 'Affiliation': 'Grenoble Alpes University Hospital, Clinical Pharmacology, Grenoble, France.'}]",Journal of clinical pharmacology,['10.1002/jcph.1574']
3473,31806127,Risk Factors for Infections Involving Cardiac Implanted Electronic Devices.,"BACKGROUND


Cardiac implantable electronic device infection is a major complication that usually requires device removal. PADIT (Prevention of Arrhythmia Device Infection Trial) was a large cluster crossover trial of conventional versus incremental antibiotics.
OBJECTIVES


This study sought to investigate independent predictors of device infection in PADIT and develop a novel infection risk score.
METHODS


In brief, over 4 6-month periods, 28 centers used either conventional or incremental prophylactic antibiotic treatment in all patients. The primary outcome was hospitalization for device infection within 1 year (blinded endpoint adjudication). Multivariable logistic prediction modeling was used to identify the independent predictors and develop a risk score for device infection. The prediction models were internally validated with bootstrap methods.
RESULTS


Device procedures were performed in 19,603 patients, and hospitalization for infection occurred in 177 (0.90%) within 1 year of follow-up. The final prediction model identified 5 independent predictors of device infection (prior procedures [P], age [A], depressed renal function [D], immunocompromised [I], and procedure type [T]) with an optimism-corrected C-statistic of 0.704 (95% confidence interval: 0.660 to 0.744). A PADIT risk score ranging from 0 to 15 points classified patients into low (0 to 4), intermediate (5 to 6) and high (≥7) risk groups with rates of hospitalization for infection of 0.51%, 1.42%, and 3.41%, respectively.
CONCLUSIONS


This study identified 5 independent predictors of device infection and developed a novel infection risk score in the largest cardiac implantable electronic device trial to date, warranting validation in an independent cohort. The 5 independent predictors in the PADIT score are readily adopted into clinical practice. (Prevention of Arrhythmia Device Infection Trial [PADIT Pilot]; NCT01002911).",2019,"RESULTS


Device procedures were performed in 19,603 patients, and hospitalization for infection occurred in 177 (0.90%) within 1 year of follow-up.",[],"['conventional or incremental prophylactic antibiotic treatment', 'conventional versus incremental antibiotics']","['novel infection risk score', 'depressed renal function [D], immunocompromised [I], and procedure type [T]) with an optimism-corrected C-statistic of 0.704', 'hospitalization for infection', 'hospitalization for device infection']",[],"[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}, {'cui': 'C0455713', 'cui_str': 'Procedure type (qualifier value)'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",19603.0,0.110691,"RESULTS


Device procedures were performed in 19,603 patients, and hospitalization for infection occurred in 177 (0.90%) within 1 year of follow-up.","[{'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Birnie', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Alings', 'Affiliation': 'Amphia Ziekenhuis and Working Group on Cardiovascular Research the Netherlands, Breda, the Netherlands.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Philippon', 'Affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec, Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Ratika', 'Initials': 'R', 'LastName': 'Parkash', 'Affiliation': 'Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Jaimie', 'Initials': 'J', 'LastName': 'Manlucu', 'Affiliation': 'Lawson Health Research Institute, London Health Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Angaran', 'Affiliation': 'Department of Medicine, University of Toronto, Division of Cardiology, St. Michael Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rinne', 'Affiliation': ""St. Mary's General Hospital, Kitchener, Ontario, Canada.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Coutu', 'Affiliation': ""Centre hospitalier de l'Université de Montréal, University of Montreal, Montreal, Quebec, Canada.""}, {'ForeName': 'R Aaron', 'Initials': 'RA', 'LastName': 'Low', 'Affiliation': 'Chinook Regional Hospital, Lethbridge, Alberta, Canada.'}, {'ForeName': 'Vidal', 'Initials': 'V', 'LastName': 'Essebag', 'Affiliation': 'McGill University Health Center, Montreal, Quebec, Canada.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Morillo', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Redfearn', 'Affiliation': ""Kingston General Hospital, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Toal', 'Affiliation': 'Horizon Health Network, Saint John, New Brunswick, Canada.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Becker', 'Affiliation': 'Hôpital du Sacré-Coeur de Montréal, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Degrâce', 'Affiliation': 'Hôtel-Dieu de Lévis, Lévis, Quebec, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Thibault', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Crystal', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Tung', 'Affiliation': ""St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'LeMaitre', 'Affiliation': 'Royal Columbian Hospital, New Westminster, British Columbia, Canada.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Sultan', 'Affiliation': 'Regina General Hospital, Saskatchewan Health Authority, Regina, Saskatchewan, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bennett', 'Affiliation': 'Regina General Hospital, Saskatchewan Health Authority, Regina, Saskatchewan, Canada; Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jamil', 'Initials': 'J', 'LastName': 'Bashir', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ayala-Paredes', 'Affiliation': 'Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gervais', 'Affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec, Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Rioux', 'Affiliation': 'Centre de santé et de services sociaux de Rimouski-Neigette, Rimouski, Quebec, Canada.'}, {'ForeName': 'Martin E W', 'Initials': 'MEW', 'LastName': 'Hemels', 'Affiliation': 'Rijnstate Hospital, Arnhem, the Netherlands; Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Leon H R', 'Initials': 'LHR', 'LastName': 'Bouwels', 'Affiliation': 'Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands.'}, {'ForeName': 'Derek V', 'Initials': 'DV', 'LastName': 'Exner', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': 'Department of Medicine, University of Toronto, Division of Cardiology, St. Michael Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Longtin', 'Affiliation': 'Jewish General Hospital Sir Mortimer B. Davis, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krahn', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: akrahn@mail.ubc.ca.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.060']
3474,32076963,Flattened flanged intrascleral intraocular lens fixation technique.,"AIM


To evaluate the visual outcomes of the patients who had undergone sutureless scleral fixated IOL implantation operation in which a new modified Yamane technique called flattened flanged intrascleral intraocular lens fixation technique was applied.
MATERIALS AND METHODS


Forty-two eyes of 42 patients who had undergone scleral IOL fixation operation with Yamane technique comprised Group 1. The mean age of this group was 60.24 ± 14.3 (20-77) years. Out of 42 patients, 25 of them (60%) were males and 17 of them (40%) were females. Forty-three eyes of 43 patients who had undergone scleral IOL fixation operation with flattened flange technique comprised Group 2. The mean age of this group was 55.35 ± 15.77 (18-79) years. Out of 43 patients, 23 (53.4%) of them were males and 20 (46.6%) were females.
RESULTS


There were no significant differences between two groups in respect to mean preoperative UCVA, postoperative UCVA, preoperative BCVA, and postoperative BCVA (p values 0.35, 0.11, 0.28, and 0.16, respectively). The mean postoperative UCVA and preoperative BCVA were significantly higher than those of preoperative values in both groups (p < 0.05). Intraoperative haptic sliding occurred in three eyes (7%) in the first group, and there was no intraoperative haptic sliding in the second group (0%) (p = 0.05). Postoperative IOL dislocation occurred in one eye (2.5%) in the first group, and there was no postoperative IOL dislocation in the second group (0%) (p = 0.32).
CONCLUSION


In conclusion, this technique does not require sutures, decreases intraoperative haptic sliding, may provide more IOL stability and less tilt, and facilitates the implantation of the second haptic. For long-term results, further studies should be conducted.",2020,"There were no significant differences between two groups in respect to mean preoperative UCVA, postoperative UCVA, preoperative BCVA, and postoperative BCVA (p values 0.35, 0.11, 0.28, and 0.16, respectively).","['The mean age of this group was 60.24\u2009±\u200914.3 (20-77) years', '43 patients, 23 (53.4%) of them were males and 20 (46.6%) were females', 'patients who had undergone sutureless scleral fixated IOL implantation operation in which a new modified Yamane technique called flattened flanged intrascleral intraocular lens fixation technique was applied', '42 patients, 25 of them (60%) were males and 17 of them (40%) were females', 'Forty-three eyes of 43 patients who had undergone scleral IOL fixation operation with flattened flange technique comprised Group 2', 'Forty-two eyes of 42 patients who had undergone scleral IOL fixation operation with Yamane technique comprised Group 1']",['Flattened flanged intrascleral intraocular lens fixation technique'],"['Postoperative IOL dislocation', 'mean postoperative UCVA and preoperative BCVA', 'postoperative IOL dislocation', 'mean preoperative UCVA, postoperative UCVA, preoperative BCVA, and postoperative BCVA', 'intraoperative haptic sliding', 'Intraoperative haptic sliding']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]","[{'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0948292', 'cui_str': 'IOL dislocation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]",42.0,0.0112746,"There were no significant differences between two groups in respect to mean preoperative UCVA, postoperative UCVA, preoperative BCVA, and postoperative BCVA (p values 0.35, 0.11, 0.28, and 0.16, respectively).","[{'ForeName': 'Fikret', 'Initials': 'F', 'LastName': 'Ucar', 'Affiliation': 'Konyagoz Eye Hospital, Sancak Mah. Unluer Sok. No:13, 42000, Selcuklu, Konya, Turkey. fikretucar@konyagoz.com.'}, {'ForeName': 'Servet', 'Initials': 'S', 'LastName': 'Cetinkaya', 'Affiliation': 'Konyagoz Eye Hospital, Sancak Mah. Unluer Sok. No:13, 42000, Selcuklu, Konya, Turkey.'}]",International ophthalmology,['10.1007/s10792-020-01312-9']
3475,32076964,"Corneal topography, anterior segment and high-order aberration assessments in children with ≥ 2 diopter astigmatism.","PURPOSE


To assess topographic findings, anterior segment parameters and high-order aberrations (HOAs) by using corneal tomography in children with 2 diopters (dp) or more astigmatism.
METHODS


Children with 2 dp or more astigmatism (study group) and children with astigmatism less than 1 dp (control group) were recruited. Corneal astigmatism, mean, steep, flat keratometry (K) findings, anterior and posterior K results and anterior segment parameters including anterior chamber depth, kappa distance, horizontal corneal diameter, mean, central, middle, peripheral corneal thicknesses (CT), white-to-white (WTW) distance and pupil diameter were measured by Galilei G4 Dual Scheimpflug corneal tomography. HOAs were also assessed and compared between groups.
RESULTS


Fifty-eight eyes of 37 children in the study group and 37 eyes of 37 children in the control group were enrolled. The mean ages of groups were 9.7 ± 2.4 years and 9.3 ± 1.6 years in study and control groups, respectively. The mean astigmatism was 3.3 ± 1.1 dp and 0.5 ± 0.3 dp in study and control groups, respectively (p < 0.05). Total corneal astigmatism was 3.3 ± 0.84 dp and 1.14 ± 0.47 dp in study and control groups, respectively (p < 0.05). There was a significant difference between groups in terms of posterior steep K and posterior astigmatism values. Among anterior segment parameters, mean CT and WTW values were statistically different between groups. HOAs were found to be statistically different between groups.
CONCLUSION


Higher posterior corneal astigmatism, thinner mean CT and lower WTW distance were found in children with 2 dp or more astigmatism. Besides, HOAs were much more in these astigmatic children.",2020,"Higher posterior corneal astigmatism, thinner mean CT and lower WTW distance were found in children with 2 dp or more astigmatism.","['Fifty-eight eyes of 37 children in the study group and 37 eyes of 37 children in the control group were enrolled', 'children with 2\xa0diopters (dp) or more astigmatism', 'Children with 2\xa0dp or more astigmatism (study group) and children with astigmatism less than 1\xa0dp (control group) were recruited', 'The mean ages of groups were 9.7\u2009±\u20092.4\xa0years and 9.3\u2009±\u20091.6\xa0years in study and control groups, respectively', 'children with ≥\u20092 diopter astigmatism']",[],"['Higher posterior corneal astigmatism, thinner mean CT and lower WTW distance', 'Corneal astigmatism, mean, steep, flat keratometry (K) findings, anterior and posterior K results and anterior segment parameters including anterior chamber depth, kappa distance, horizontal corneal diameter, mean, central, middle, peripheral corneal thicknesses (CT), white-to-white (WTW) distance and pupil diameter', 'posterior steep K and posterior astigmatism values', 'Total corneal astigmatism', 'HOAs', 'mean astigmatism', 'Corneal topography, anterior segment and high-order aberration assessments', 'mean CT and WTW values']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0339682', 'cui_str': 'Corneal astigmatism'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205324', 'cui_str': 'Flat (qualifier value)'}, {'cui': 'C0430885', 'cui_str': 'Keratometry (procedure)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0348014', 'cui_str': 'Anterior segment (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0003151', 'cui_str': 'Anterior Chamber'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0429515', 'cui_str': 'Horizontal corneal diameter (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness (observable entity)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0524957', 'cui_str': 'Corneal Topography'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",37.0,0.0181475,"Higher posterior corneal astigmatism, thinner mean CT and lower WTW distance were found in children with 2 dp or more astigmatism.","[{'ForeName': 'Burçin', 'Initials': 'B', 'LastName': 'Çakır', 'Affiliation': 'Sakarya University Education and Research Hospital, Sakarya, Turkey. b_koklu@yahoo.com.'}, {'ForeName': 'Nilgün Özkan', 'Initials': 'NÖ', 'LastName': 'Aksoy', 'Affiliation': 'Sakarya University Education and Research Hospital, Sakarya, Turkey.'}, {'ForeName': 'Sedat', 'Initials': 'S', 'LastName': 'Özmen', 'Affiliation': 'Sakarya University Education and Research Hospital, Sakarya, Turkey.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Bursalı', 'Affiliation': 'Sakarya University Education and Research Hospital, Sakarya, Turkey.'}, {'ForeName': 'Erkan', 'Initials': 'E', 'LastName': 'Çelik', 'Affiliation': 'Sakarya University Education and Research Hospital, Sakarya, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Horozoğlu', 'Affiliation': 'Tekirdağ Namık Kemal University, Tekirdağ, Turkey.'}]",International ophthalmology,['10.1007/s10792-020-01313-8']
3476,32076966,Comparison of visual quality after Femto-LASIK and TransPRK in patients with low and moderate myopia.,"PURPOSE


To compare the visual quality after surgery of femtosecond-assisted laser in situ keratomileusis (Femto-LASIK) and transepithelial photorefractive keratectomy (TransPRK) in low and moderate myopia patients.
METHODS


A prospective controlled study was performed on 114 eyes of 62 patients with low to moderate myopia, including 64 eyes of 36 cases in Femto-LASIK group and 50 eyes of 26 cases in TransPRK group. The uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), residual spherical equivalent (SE), wavefront aberration and contrast sensitivity were examined and analyses preoperatively, 1 month and 3 months postoperatively.
RESULTS


The UCVA over 0.8 was 100% in two groups at 1 month and 3 months postoperatively. Femto-LASIK group (96.49%) had a higher percentage than TransPRK group (67.39%) of UCVA over 1.0 at 1 month postoperatively (p < 0.001), but it was similar in two groups (97.78%, 90.48%) at 3 months postoperatively (p = 0.15). Femto-LASIK group (77.19%, 86.67%) had a higher percentage than TransPRK group (30.43%, 52.38%) of UCVA over 1.2 at 1 month and 3 months postoperatively (p < 0.001, p = 0.001). The SE of Femto-LASIK group was 0.07 ± 0.21 D, 0.02 ± 0.23 D at 1 month and 3 months postoperatively, and of TransPRK group was 0.11 ± 0.31 D, 0.14 ± 0.38 D; two groups had no significant differences (p = 0.57, p = 0.08). The safety index was 2.0 in Femto-LASIK group and 1.6 in TransPRK, while the efficacy index was 1.67 and 0.4, respectively. The vertical coma, spherical and higher-order aberrations of Femto-LASIK group were 0.37 ± 0.54 μm, 0.31 ± 0.27 μm, 0.89 ± 0.49 μm at 1 month postoperatively, and of TransPRK group were 0.12 ± 0.38 μm, 0.14 ± 0.28 μm, 0.71 ± 0.26 μm. There was significant difference between two groups at 1 months postoperatively (p < 0.001, p = 0.001, p = 0.006), but no significant difference at 3 months (p > 0.05). The contrast sensitivity without glare in 18 c/d spatial frequencies of Femto-LASIK group was 1.08 ± 0.26 at 1 month postoperatively, and that in TransPRK group was 0.99 ± 0.22. There was significant difference between two groups (p = 0.02). The contrast sensitivity with glare in 12 c/d and 18 c/d spatial frequencies at 1 month postoperatively had significant differences between Femto-LASIK and TransPRK groups (1.52 ± 0.17, 1.10 ± 0.23 vs 1.38 ± 0.39, 1.00 ± 0.27, p = 0.02, p = 0.03). While there were no significant differences at 3 months postoperatively (p > 0.05).
CONCLUSION


Femto-LASIK had a higher increase in whole eye higher-order aberrations and contrast sensitivity than TransPRK at 1 month postoperatively, but they were similar at 3 months postoperatively in low and moderate myopia patients.",2020,"While there were no significant differences at 3 months postoperatively (p > 0.05).
","['114 eyes of 62 patients with low to moderate myopia, including 64 eyes of 36 cases in Femto-LASIK group and 50 eyes of 26 cases in TransPRK group', 'patients with low and moderate myopia', 'low and moderate myopia patients']","['femtosecond-assisted laser in situ keratomileusis (Femto-LASIK) and transepithelial photorefractive keratectomy (TransPRK', 'Femto-LASIK', 'Femto-LASIK and TransPRK']","['contrast sensitivity without glare', 'contrast sensitivity with glare', 'UCVA', 'visual quality', 'uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), residual spherical equivalent (SE), wavefront aberration and contrast sensitivity', 'efficacy index', 'safety index']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0752094', 'cui_str': 'Laser-Assisted Stromal In Situ Keratomileusis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0752094', 'cui_str': 'Laser-Assisted Stromal In Situ Keratomileusis'}, {'cui': 'C0395416', 'cui_str': 'Photorefractive Keratectomy'}]","[{'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C3887688', 'cui_str': 'Glare (finding)'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1532952', 'cui_str': 'Wavefront aberration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",62.0,0.0287523,"While there were no significant differences at 3 months postoperatively (p > 0.05).
","[{'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong, Dong Xia North Road, Shantou, Guangdong Province, China.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Jhanji', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh, USA.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong, Dong Xia North Road, Shantou, Guangdong Province, China.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong, Dong Xia North Road, Shantou, Guangdong Province, China.'}, {'ForeName': 'Riping', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong, Dong Xia North Road, Shantou, Guangdong Province, China. zrp@jsiec.org.'}]",International ophthalmology,['10.1007/s10792-020-01308-5']
3477,31369089,Safety and Efficacy of 5 Years of Treatment With Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism.,"CONTEXT


Conventional hypoparathyroidism treatment with oral calcium and active vitamin D is aimed at correcting hypocalcemia but does not address other physiologic defects caused by PTH deficiency.
OBJECTIVE


To evaluate long-term safety and tolerability of recombinant human PTH (1-84) [rhPTH(1-84)].
DESIGN


Open-label extension study; 5-year interim analysis.
SETTING


12 US centers.
PATIENTS


Adults (N = 49) with chronic hypoparathyroidism.
INTERVENTION(S)


rhPTH(1-84) 25 or 50 µg/d initially, with 25-µg adjustments permitted to a 100 µg/d maximum.
MAIN OUTCOME MEASURE(S)


Safety parameters; composite efficacy outcome was the proportion of patients with ≥50% reduction in oral calcium (or ≤500 mg/d) and calcitriol (or ≤0.25 µg/d) doses, and albumin-corrected serum calcium normalized or maintained compared with baseline, not exceeding upper limit of normal.
RESULTS


Forty patients completed 60 months of treatment. Mean albumin-corrected serum calcium levels remained between 8.2 and 8.7 mg/dL. Between baseline and month 60, levels ± SD of urinary calcium, serum phosphorus, and calcium-phosphorus product decreased by 101.2 ± 236.24 mg/24 hours, 1.0 ± 0.78 mg/dL, and 8.5 ± 8.29 mg2/dL2, respectively. Serum creatinine level and estimated glomerular filtration rate were unchanged. Treatment-emergent adverse events (AEs) were reported in 48 patients (98.0%; hypocalcemia, 36.7%; muscle spasms, 32.7%; paresthesia, 30.6%; sinusitis, 30.6%; nausea, 30.6%) and serious AEs in 13 (26.5%). At month 60, 28 patients (70.0%) achieved the composite efficacy outcome. Bone turnover markers increased, peaked at ∼12 months, and then declined to values that remained above baseline.
CONCLUSION


Treatment with rhPTH(1-84) for 5 years demonstrated a safety profile consistent with previous studies and improved key biochemical parameters.",2019,Serum creatinine and estimated glomerular filtration rate were unchanged.,"['Forty patients completed 60 months of treatment', '12 US centers', 'Adults (N=49) with chronic hypoparathyroidism', 'Adults With Hypoparathyroidism']","['recombinant human PTH(1-84) (rhPTH[1-84', 'oral calcium', 'calcitriol', 'oral calcium and active vitamin D', 'Recombinant Human Parathyroid Hormone', 'rhPTH(1-84']","['Serum creatinine and estimated glomerular filtration rate', 'composite efficacy outcome', 'calcium-phosphorus product', 'serum phosphorus', 'urinary calcium', 'Mean albumin-corrected serum calcium', 'Safety and Efficacy', 'Bone turnover markers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0006674', 'cui_str': '1,25-dihydroxycholecalciferol'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0020063', 'cui_str': 'hPTH(1-84)'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C3811844'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}]",40.0,0.0483122,Serum creatinine and estimated glomerular filtration rate were unchanged.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mannstadt', 'Affiliation': 'Endocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Clarke', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Bilezikian', 'Affiliation': 'Division of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Bone', 'Affiliation': 'Michigan Bone and Mineral Clinic, PC, Detroit, Michigan.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Denham', 'Affiliation': 'Clinical Trials of Texas, Inc., San Antonio, Texas.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Levine', 'Affiliation': ""Division of Endocrinology and Diabetes and Center for Bone Health, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Munro', 'Initials': 'M', 'LastName': 'Peacock', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Rothman', 'Affiliation': 'University Physicians Group - Research Division, Staten Island, New York.'}, {'ForeName': 'Dolores M', 'Initials': 'DM', 'LastName': 'Shoback', 'Affiliation': 'Endocrine Research Unit, Department of Medicine, San Francisco Veterans Affairs Medical Center, University of California, San Francisco, California.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Warren', 'Affiliation': 'Endocrinology and Metabolism, Physicians East, Greenville, North Carolina.'}, {'ForeName': 'Nelson B', 'Initials': 'NB', 'LastName': 'Watts', 'Affiliation': 'Osteoporosis and Bone Health Services, Mercy Health, Cincinnati, Ohio.'}, {'ForeName': 'Hak-Myung', 'Initials': 'HM', 'LastName': 'Lee', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a member of the Takeda group of companies, Lexington, Massachusetts.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sherry', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a member of the Takeda group of companies, Cambridge, Massachusetts.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Vokes', 'Affiliation': 'Section of Endocrinology, University of Chicago Medicine, Chicago, Illinois.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-01010']
3478,31362674,Effect of Levetiracetam on Cognitive Function and Clonic Seizure Frequency in Children with Epilepsy.,"OBJECTIVE


This study aimed to explore the clinical effect of levetiracetam in the treatment of children with epilepsy.
METHODS


136 children with epilepsy were selected from January 2017 to December 2017. According to the random number table method, they were divided into the experimental group and the conventional group, with 68 cases in each group. The conventional group was treated with valproate, while the experimental group was treated with levetiracetam. The effective rate, the cognitive function and the frequency of clonic seizures in the two groups were compared.
RESULTS


There was no significant difference in the total effective rate between the two groups (P>0.05). There was no significant difference in attention, executive ability, abstract and orientation scores between the two groups before treatment (P>0.05). After treatment, the focus of attention (106.54±6.56), executive ability (105.76±6.77), abstract and directional score (106.65±6.57) were significantly higher than that of the conventional group. The difference in the two groups was statistically significant (P<0.05). After 3 months of treatment, the frequency of myoclonic seizures (9.22±0.95) and the frequency of tonic-clonic seizures (11.68±1.36) were found to be significantly lower than those of the conventional group, and the difference between the two groups was statistically significant (P<0.05).
CONCLUSION


Levetiracetam is effective in the treatment of children with epilepsy. It can effectively improve the cognitive function of the patients, reduce the frequency of myoclonic seizures and tonic-clonic seizures, and has a high promotion value.",2019,"There was no significant difference in attention, executive ability, abstract and orientation scores between the two groups before treatment (P>0.05).","['136 children with epilepsy were selected from January 2017 to December 2017', 'children with epilepsy']","['valproate', 'Levetiracetam', 'levetiracetam']","['cognitive function and clonic seizure frequency', 'attention, executive ability, abstract and orientation scores', 'effective rate, the cognitive function and the frequency of clonic seizures', 'frequency of myoclonic seizures', 'frequency of tonic clonic seizures', 'concentration of attention (106.54±6.56), executive ability (105.76±6.77), abstract and directional score', 'cognitive function', 'total effective rate']","[{'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}]","[{'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0234535', 'cui_str': 'Clonic Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600678', 'cui_str': 'Abstracts'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C4317123', 'cui_str': 'Myoclonic Seizures'}, {'cui': 'C0494475', 'cui_str': 'Generalized Tonic-Clonic Seizures'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",136.0,0.0211517,"There was no significant difference in attention, executive ability, abstract and orientation scores between the two groups before treatment (P>0.05).","[{'ForeName': 'Shihao', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Genetic and Eugenics,Changsha Hospital for Maternal and Child Health Care, Changsha, Hunan, 410011, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Zhan', 'Affiliation': 'Department of Neurology, Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China.'}]",Current molecular medicine,['10.2174/1566524019666190729113321']
3479,31586370,Cost-Effectiveness of Therapist-Guided Internet-Based Cognitive Behavioral Therapy for Stress-Related Disorders: Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND


Stress-related disorders are associated with significant suffering, functional impairment, and high societal costs. Internet-based cognitive behavioral therapy (ICBT) is a promising treatment for stress-related disorders but has so far not been subjected to health economic evaluation.
OBJECTIVE


The objective of this study was to evaluate the cost-effectiveness and cost-utility of ICBT for patients with stress-related disorders in the form of adjustment disorder (AD) or exhaustion disorder (ED). We hypothesized that ICBT, compared with a waitlist control (WLC) group, would generate improvements at low net costs, thereby making it cost-effective.
METHODS


Health economic data were obtained in tandem with a randomized controlled trial of a 12-week ICBT in which patients (N=100) were randomized to an ICBT (n=50) or a WLC (n=50) group. Health outcomes and costs were surveyed pre- and posttreatment. We calculated incremental cost-effectiveness ratios (ICERs) based on remission rates and incremental cost-utility ratios (ICURs) based on health-related quality of life. Bootstrap sampling was used to assess the uncertainty of our results.
RESULTS


The ICER indicated that the most likely scenario was that ICBT led to higher remission rates compared with the WLC and was associated with slightly larger reductions in costs from pre- to posttreatment. ICBT had a 60% probability of being cost-effective at a willingness to pay (WTP) of US $0 and a 96% probability of being cost-effective at a WTP of US $1000. The ICUR indicated that ICBT also led to improvements in quality of life at no net societal cost. Sensitivity analyses supported the robustness of our results.
CONCLUSIONS


The results suggest that ICBT is a cost-effective treatment for patients suffering from AD or ED. Compared with no treatment, ICBT for these patients yields large effects at no or minimal societal net costs.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02540317; https://clinicaltrials.gov/ct2/show/NCT02540317.",2019,The ICER indicated that the most likely scenario was that ICBT led to higher remission rates compared with the WLC and was associated with slightly larger reductions in costs from pre- to posttreatment.,"['patients suffering from AD or ED', 'patients with stress-related disorders in the form of adjustment disorder (AD) or exhaustion disorder (ED', 'Stress-Related Disorders', 'patients (N=100']","['Therapist-Guided Internet-Based Cognitive Behavioral Therapy', 'Internet-based cognitive behavioral therapy (ICBT', 'ICBT', 'WLC', 'waitlist control (WLC']","['cost-effectiveness and cost-utility', 'remission rates', 'incremental cost-effectiveness ratios (ICERs) based on remission rates and incremental cost-utility ratios (ICURs) based on health-related quality of life', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0001546', 'cui_str': 'Reactive Disorders'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.119681,The ICER indicated that the most likely scenario was that ICBT led to higher remission rates compared with the WLC and was associated with slightly larger reductions in costs from pre- to posttreatment.,"[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Lindsäter', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Axelsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Salomonsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Santoft', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Åkerstedt', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",Journal of medical Internet research,['10.2196/14675']
3480,31358329,Levosimendan in patients with reduced left ventricular function undergoing isolated coronary or valve surgery.,"OBJECTIVE


In the Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial, no differences in clinical outcomes were observed between levosimendan and placebo in a broad population of patients undergoing cardiac surgery. In previous studies, the benefits of levosimendan were most clearly evident in patients undergoing isolated coronary artery bypass grafting (CABG) surgery. In a prespecified analysis of LEVO-CTS, we compared treatment-related outcomes and costs across types of cardiac surgical procedures.
METHODS


Overall, 563 (66.4%) patients underwent isolated CABG, 97 (11.4%) isolated valve, and 188 (22.2%) combined CABG/valve surgery. Outcomes included the co-primary 4-component composite (30-day mortality, 30-day renal replacement, 5-day myocardial infarction, or 5-day mechanical circulatory support), the 2-component composite (30-day mortality or 5-day mechanical circulatory support), 90-day mortality, low cardiac output syndrome (LCOS), and 30-day medical costs.
RESULTS


The 4- and 2-component outcomes were not significantly different with levosimendan and placebo in patients undergoing CABG (15.2% vs 19.3% and 7.8% vs 10.4%), valve (49.0% vs 33.3% and 22.4% vs 2.1%), or combined procedures (39.6% vs 35.9% and 24.0% vs 19.6%). Ninety-day mortality was lower with levosimendan in isolated CABG (2.1% vs 7.9%; hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.11-0.64), but not significantly different in valve (8.3% vs 2.0%; HR, 4.10; 95% CI, 0.46-36.72) or combined procedures (10.4% vs 7.6%; HR, 1.39; 95% CI, 0.53-3.64; interaction P = .011). LCOS (12.0% vs 22.1%; odds ratio, 0.48; 95% CI, 0.30-0.76; interaction P = .118) was significantly lower in levosimendan-treated patients undergoing isolated CABG. Excluding study drug costs, median and mean 30-day costs were $53,707 and $65,852 for levosimendan and $54,636 and $67,122 for placebo, with a 30-day mean difference (levosimendan - placebo) of -$1270 (bootstrap 95% CI, -$8722 to $6165).
CONCLUSIONS


Levosimendan was associated with lower 90-day mortality and LCOS in patients undergoing isolated CABG, but not in those undergoing isolated valve or combined CABG/valve procedures.",2020,"The 4- and 2-component outcomes were not significantly different with levosimendan and placebo in patients undergoing CABG (15.2% vs 19.3% and 7.8% vs 10.4%), valve (49.0% vs 33.3% and 22.4% vs 2.1%), or combined procedures (39.6% vs 35.9% and 24.0% vs 19.6%).","['patients undergoing isolated coronary artery bypass grafting (CABG) surgery', 'patients undergoing cardiac surgery', 'Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial', 'patients with reduced left ventricular function undergoing isolated coronary or valve surgery']","['placebo', 'levosimendan', 'Levosimendan', 'levosimendan and placebo']","['co-primary 4-component composite (30-day mortality, 30-day renal replacement, 5-day myocardial infarction, or 5-day mechanical circulatory support), the 2-component composite (30-day mortality or 5-day mechanical circulatory support), 90-day mortality, low cardiac output syndrome (LCOS), and 30-day medical costs', 'valve', 'LCOS', 'median and mean 30-day costs', '90-day mortality and LCOS', 'Ninety-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0246904', 'cui_str': 'Levosimendan'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0600177', 'cui_str': 'Low Cardiac Output Syndrome'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}]",,0.314909,"The 4- and 2-component outcomes were not significantly different with levosimendan and placebo in patients undergoing CABG (15.2% vs 19.3% and 7.8% vs 10.4%), valve (49.0% vs 33.3% and 22.4% vs 2.1%), or combined procedures (39.6% vs 35.9% and 24.0% vs 19.6%).","[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'van Diepen', 'Affiliation': 'Division of Cardiology, Departments of Critical Care and Medicine, University of Alberta, Edmonton, Alberta, Canada; Canadian VIGOUR Center, University of Alberta, Edmonton, Alberta, Canada. Electronic address: sv9@ualberta.ca.'}, {'ForeName': 'Rajendra H', 'Initials': 'RH', 'LastName': 'Mehta', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Leimberger', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian VIGOUR Center, University of Alberta, Edmonton, Alberta, Canada; Terrence Donnelly Heart Centre, Division of Cardiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Fremes', 'Affiliation': 'Schulich Heart Center, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Jankowich', 'Affiliation': 'Tenax Therapeutics, Morrisville, NC.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Heringlake', 'Affiliation': 'University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jerrold H', 'Initials': 'JH', 'LastName': 'Levy', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Luber', 'Affiliation': 'Franciscan Health System, Tacoma, Wash.'}, {'ForeName': 'A Dave', 'Initials': 'AD', 'LastName': 'Nagpal', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Andra E', 'Initials': 'AE', 'LastName': 'Duncan', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Argenziano', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Toller', 'Affiliation': 'Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Teoh', 'Affiliation': 'Southlake Regional Health Center, Newmarket, Ontario, Canada.'}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Knight', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cowper', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.06.020']
3481,31356558,Oral Nano Vitamin D Supplementation Reduces Disease Activity in Ulcerative Colitis: A Double-Blind Randomized Parallel Group Placebo-controlled Trial.,"INTRODUCTION


Vitamin D possesses anti-inflammatory properties and could be beneficial in ulcerative colitis (UC).
METHODS


We studied the effect of oral nano vitamin D3 supplementation on disease activity in active UC [ulcerative colitis disease activity index (UCDAI)≥3]. Patients with active UC and vitamin D <40 ng/mL were randomized to receive either oral nano vitamin D (60,000 IU/d×8 d) or placebo. They were evaluated for disease activity (UCDAI scores, C-reactive protein, erythrocyte sedimentation rate, and fecal calprotectin) at baseline and reassessed at 4 weeks. The response was defined as a 3-point reduction in UCDAI score at 4 weeks and reduction in inflammatory markers.
RESULTS


The median vitamin D levels increased from 15.4 to 40.83 mg/dL in vitamin D group (P≤0.001) and marginally from 13.45 to 18.85 mg/dL (P=0.027) in controls. The 3-point reduction in UCDAI was seen more often in vitamin D group as compared with the control (53% vs. 13%; P=0.001). Increase in vitamin D levels correlated with reduction in UCDAI score (P≤0.001; ρ=-0.713), C-reactive protein (P≤0.001; ρ=-0.603), and calprotectin (P=0.004; ρ=-0.368). Patients who achieved target vitamin D of >40 ng/mL (n=17) more often had a 3-point reduction in UCDAI (80% vs. 20%; P≤0.001) and reduction in grade of severity from 60% to 35% (P=0.038). Vitamin D administration (odds ratio, 9.17; 95% confidence interval, 2.02-41.67) and baseline histologic activity (odds ratio, 1.92; 95% confidence intervals, 1.2-3.08) independently predicted response.
CONCLUSIONS


Oral nano vitamin D supplementation in active UC is associated with a reduction in disease activity and severity grade and is seen more often in those who achieved a target vitamin D level of 40 ng/mL.",2019,"Vitamin D administration (odds ratio, 9.17; 95% confidence interval, 2.02-41.67) and baseline histologic activity (odds ratio, 1.92; 95% confidence intervals, 1.2-3.08) independently predicted response.
","['Patients with active UC and', 'Ulcerative Colitis', 'Patients who achieved target vitamin D of >40\u2009ng/mL']","['placebo', 'Oral Nano Vitamin D Supplementation', 'vitamin D', 'oral nano vitamin D3 supplementation', 'Placebo', 'Vitamin D', 'oral nano vitamin D']","['median vitamin D levels', '3-point reduction in UCDAI', 'grade of severity', 'C-reactive protein', 'vitamin D levels', 'UCDAI', 'disease activity (UCDAI scores, C-reactive protein, erythrocyte sedimentation rate, and fecal calprotectin', 'UCDAI score', 'baseline histologic activity', 'Disease Activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}]",,0.691689,"Vitamin D administration (odds ratio, 9.17; 95% confidence interval, 2.02-41.67) and baseline histologic activity (odds ratio, 1.92; 95% confidence intervals, 1.2-3.08) independently predicted response.
","[{'ForeName': 'Rizwan', 'Initials': 'R', 'LastName': 'Ahamed Z', 'Affiliation': 'Department of Gastroenterology.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Dutta', 'Affiliation': 'Department of Gastroenterology.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Department of Gastroenterology.'}, {'ForeName': 'Kaushal Kishor', 'Initials': 'KK', 'LastName': 'Prasad', 'Affiliation': 'Department of Gastroenterology.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Popli', 'Affiliation': 'Department of Gastroenterology.'}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Kalsi', 'Affiliation': 'Department of Gastroenterology.'}, {'ForeName': 'Chetana', 'Initials': 'C', 'LastName': 'Vaishnavi', 'Affiliation': 'Department of Gastroenterology.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Gastroenterology.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kochhar', 'Affiliation': 'Department of Gastroenterology.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001233']
3482,31939768,Intergroup anxiety in pain care: impact on treatment recommendations made by white providers for black patients.,"Race disparities in pain care are well-documented. Given that most black patients are treated by white providers, patient-provider racial discordance is one hypothesized contributor to these disparities. Research and theory suggest that providers' trait-level intergroup anxiety impacts their state-level comfort while treating patients, which, in turn, impacts their pain treatment decisions. To test these hypothesized relationships, we conducted a planned secondary analysis of data from a randomized controlled trial of a perspective-taking intervention to reduce pain treatment disparities. Mediation analyses were conducted on treatment decision data from white providers for black virtual patients with chronic pain. Results indicated that white providers with higher trait-level intergroup anxiety reported lower state-level comfort treating black patients and were thereby more likely to recommend opioid (indirect effect = 0.76, 95% confidence interval [CI]: 0.21-1.51) and pain specialty (indirect effect = 0.91, 95% CI: 0.26-1.78) treatments and less likely to recommend nonopioid analgesics (indirect effect = -0.45, 95% CI: -0.94 to -0.12). Neither trait-level intergroup anxiety nor state-level comfort significantly influenced provider decisions for physical therapy. This study provides important new information about intrapersonal and interpersonal contributors to race disparities in chronic pain care. These findings suggest that intergroup anxiety and the resulting situational discomfort encroach on the clinical decision-making process by influencing white providers' decisions about which pain treatments to recommend to black patients. Should these findings be replicated in future studies, they would support interventions to help providers become more aware of their trait-level intergroup anxiety and manage their state-level reactions to patients who are racially/ethnically different from themselves.",2020,Neither trait-level intergroup anxiety nor state-level comfort significantly influenced provider decisions for physical therapy.,"['Black virtual patients with chronic pain', 'White providers for Black patients']",['perspective-taking intervention'],['pain specialty'],"[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0745156,Neither trait-level intergroup anxiety nor state-level comfort significantly influenced provider decisions for physical therapy.,"[{'ForeName': 'Alexis D', 'Initials': 'AD', 'LastName': 'Grant', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Miller', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Hollingshead', 'Affiliation': 'Department of Family Medicine, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Tracy M', 'Initials': 'TM', 'LastName': 'Anastas', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Hirsh', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, United States.'}]",Pain,['10.1097/j.pain.0000000000001806']
3483,31805822,"Comparing Three Established Methods for Tinnitus Pitch Matching With Respect to Reliability, Matching Duration, and Subjective Satisfaction.","The pitch of tinnitus sound is a key characteristic that is of importance to research and sound therapies relying on exact tinnitus pitch matches. The identification of this tinnitus pitch is a challenging task as there is no objective measurement available. During the tinnitus pitch-matching procedure, the participant identifies an external sound that is most similar to the subjective perception of the tinnitus. Several methods have been developed to perform this pitch-matching procedure with tinnitus sufferers. In this study, we aimed to compare the method of adjustment, the two-alternative forced-choice (2AFC) method, and the likeness rating (LR) with respect to reliability, matching duration, and subjective satisfaction. Fifty-nine participants with chronic tinnitus were recruited and performed five consecutive runs of tinnitus matching. The participants were randomized to the three different pitch-matching methods. The intraclass correlation coefficients were .67 for method of adjustment, .63 for 2AFC, and .69 for LR, which can be interpreted as good reliability for all the three methods. However, the 2AFC method revealed significant larger within-subject variability than the other measures. Across the five runs and the three different methods, all participants learned to perform the pitch matching faster and with better self-rated accuracy. Comparing the three pitch-matching methods, LR is more time consuming and the participants were less satisfied with the 2AFC method. Overall, the three pitch-matching methods show good reliability. However, we identified differential aspects for improvement in all methods, which are discussed in this article.",2019,"Across the five runs and the three different methods, all participants learned to perform the pitch matching faster and with better self-rated accuracy.",['Fifty-nine participants with chronic tinnitus'],[],[],"[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]",[],[],59.0,0.0457088,"Across the five runs and the three different methods, all participants learned to perform the pitch matching faster and with better self-rated accuracy.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neff', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Langguth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schecklmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'Hannemann', 'Affiliation': 'Sivantos GmbH, Erlangen, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Schlee', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}]",Trends in hearing,['10.1177/2331216519887247']
3484,31358336,The del Nido versus cold blood cardioplegia in aortic valve replacement: A randomized trial.,"OBJECTIVES


To compare the cardioprotective efficacy of a solution that requires only a single infusion at the start of the ischemic duration versus a solution that requires multiple infusions.
METHODS


Aortic valve replacement was performed for 150 patients, who were randomized into the del Nido (DN) cardioplegia group or the cold blood (CB) cardioplegia group. The DN cardioplegia was delivered every 90 minutes and the CB cardioplegia was delivered every 20 to 30 minutes, or whenever cardiac activity was observed. The primary endpoints were electrical cardiac activity during crossclamp, ventricular fibrillation during reperfusion, and postoperative troponin and creatine kinase (CK-MB isoenzyme) at 24 and 48 hours.
RESULTS


Electrical activity during crossclamp occurred in 29 (39.7%) patients in the DN group versus 34 (45.3%) patients in the CB group (adjusted P = 1.0). The number of procedures with ventricular fibrillation after removing the crossclamp was 41 (54.7%) in the CB group versus 17 (22.7%) in the DN group (adjusted P = .001; relative risk, 2.41). Troponin values appeared to be lower in the DN group (median, 223.10; interquartile range, 168.35-364.77 pg/mL vs 285.5; 196.20-419.45 pg/mL at 24 hours and 159.60; 125.42-217.20 pg/mL vs 201.60; 160.62-268.45 pg/mL at 48 hours) and CK-MB (median, 14.94; interquartile range, 12.16-20.39 ng/mL vs 17.43; 13.66-22.43 ng/mL at 24 hours and 6.19; 4.41-7.63 ng/mL vs 7.38; 4.74-10.20 ng/mL at 48 hours), but no significance was found.
CONCLUSIONS


The del Nido cardioplegia protocol is an acceptable alternative for cold blood cardioplegia in patients undergoing aortic valve replacement.",2020,"The number of procedures with ventricular fibrillation after removing the crossclamp was 41 (54.7%) in the CB group versus 17 (22.7%) in the DN group (adjusted P = .001; relative risk, 2.41).","['patients undergoing aortic valve replacement', 'aortic valve replacement', 'Aortic valve replacement was performed for 150 patients']","['cold blood cardioplegia', 'CB cardioplegia', 'del Nido (DN) cardioplegia group or the cold blood (CB) cardioplegia group']","['number of procedures with ventricular fibrillation', 'Troponin values', 'electrical cardiac activity during crossclamp, ventricular fibrillation during reperfusion, and postoperative troponin and creatine kinase (CK-MB isoenzyme', 'cardioprotective efficacy', 'Electrical activity during crossclamp']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0005768'}, {'cui': 'C0018791', 'cui_str': 'Cardioplegia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0042510', 'cui_str': 'Ventricular Fibrillation'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0443168', 'cui_str': 'Cardiac activity (observable entity)'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0523584', 'cui_str': 'Creatine kinase MB measurement'}, {'cui': 'C0022173', 'cui_str': 'Isozymes'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",150.0,0.149311,"The number of procedures with ventricular fibrillation after removing the crossclamp was 41 (54.7%) in the CB group versus 17 (22.7%) in the DN group (adjusted P = .001; relative risk, 2.41).","[{'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Sanetra', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland. Electronic address: krzyssan@poczta.onet.pl.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Gerber', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Shrestha', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Domaradzki', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Krzych', 'Affiliation': 'Department of Anesthesiology and Intensive Therapy, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Zembala', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery and Transplantology, Zabrze, Poland; Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Cisowski', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland; Department of Cardiac, Vascular and Endovascular Surgery and Transplantology, Zabrze, Poland; Medical University of Silesia, Katowice, Poland.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.05.083']
3485,32049283,Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial.,"AIMS


Transcatheter aortic valve implantation (TAVI) has emerged as established treatment option in patients with symptomatic aortic stenosis. Technical developments in valve design have addressed previous limitations such as suboptimal deployment, conduction disturbances, and paravalvular leakage. However, there are only limited data available for the comparison of newer generation self-expandable valve (SEV) and balloon-expandable valve (BEV).
METHODS AND RESULTS


SOLVE-TAVI is a multicentre, open-label, 2 × 2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA). The primary efficacy composite endpoint of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days was powered for equivalence (equivalence margin 10% with significance level 0.05). The primary composite endpoint occurred in 28.4% of SEV patients and 26.1% of BEV patients meeting the prespecified criteria of equivalence [rate difference -2.39 (90% confidence interval, CI -9.45 to 4.66); Pequivalence = 0.04]. Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3% [rate difference -0.93 (90% CI -4.78 to 2.92); Pequivalence < 0.001], stroke 0.5% vs. 4.7% [rate difference 4.20 (90% CI 0.12 to 8.27); Pequivalence = 0.003], moderate/severe paravalvular leak 3.4% vs. 1.5% [rate difference -1.89 (90% CI -5.86 to 2.08); Pequivalence = 0.0001], and permanent pacemaker implantation 23.0% vs. 19.2% [rate difference -3.85 (90% CI -10.41 to 2.72) in SEV vs. BEV patients; Pequivalence = 0.06].
CONCLUSION


In patients with aortic stenosis undergoing transfemoral TAVI, newer generation SEV and BEV are equivalent for the primary valve-related efficacy endpoint. These findings support the safe application of these newer generation percutaneous valves in the majority of patients with some specific preferences based on individual valve anatomy.",2020,Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3%,"['patients with symptomatic aortic stenosis', '447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA', 'transcatheter aortic valve implantation', 'patients with aortic stenosis undergoing']","['Transcatheter aortic valve implantation (TAVI', 'transfemoral TAVI', 'generation self-expandable vs. balloon-expandable valves']","['moderate/severe paravalvular leak', 'cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter Aortic Valve Implantation'}, {'cui': 'C0458216', 'cui_str': 'Sev (substance)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter Aortic Valve Implantation'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1709508', 'cui_str': 'Paravalvular leak'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0336548', 'cui_str': 'Prosthetic valve'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",447.0,0.108761,Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3%,"[{'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kurz', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Stachel', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Hartung', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Eitel', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Marquetand', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Nef', 'Affiliation': 'Medizinische Klinik I, Abteilung für Kardiologie, Universitätsklinikum Marburg/Gießen, Klinikstr. 33, D-35392 Gießen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Doerr', 'Affiliation': 'Medizinische Klinik I, Abteilung für Kardiologie, Universitätsklinikum Marburg/Gießen, Klinikstr. 33, D-35392 Gießen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lauten', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Holzhey', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borger', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Ince', 'Affiliation': 'Medizinische Klinik I im Zentrum für Innere Medizin (ZIM), Universitätsklinikum Rostock, Ernst-Heydemann-Str. 6, D-18057 Rostock, Germany.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Öner', 'Affiliation': 'Medizinische Klinik I im Zentrum für Innere Medizin (ZIM), Universitätsklinikum Rostock, Ernst-Heydemann-Str. 6, D-18057 Rostock, Germany.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Meyer-Saraei', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'Wienbergen', 'Affiliation': 'Klinikum Links der Weser, Herzzentrum Bremen, Senator-Wessling-Str. 1, D-28277 Bremen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fach', 'Affiliation': 'Klinikum Links der Weser, Herzzentrum Bremen, Senator-Wessling-Str. 1, D-28277 Bremen, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Frey', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Inke R', 'Initials': 'IR', 'LastName': 'König', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Vonthein', 'Affiliation': 'Institut für Medizinische Biometrie und Statistik, Universität zu Lübeck, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Ratzeburger Allee 160, D-23562 Lübeck, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Rückert', 'Affiliation': 'Leipzig Heart Institute, Russenstraße 69a, D-04289 Leipzig, Germany.'}, {'ForeName': 'Anne-Kathrin', 'Initials': 'AK', 'LastName': 'Funkat', 'Affiliation': 'Leipzig Heart Institute, Russenstraße 69a, D-04289 Leipzig, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Ratzeburger Allee 160, D-23538 Lübeck, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.'}]",European heart journal,['10.1093/eurheartj/ehaa036']
3486,31303296,"Unpacking the null: a post-hoc analysis of a cluster-randomised controlled trial of the WHO Safe Childbirth Checklist in Uttar Pradesh, India (BetterBirth).","BACKGROUND


A coaching-based implementation of the WHO Safe Childbirth Checklist in Uttar Pradesh, India, improved adherence to evidence-based practices, but did not reduce perinatal mortality, maternal morbidity, or maternal mortality. We examined facility-level correlates of the outcomes, which varied widely across the 120 study facilities.
METHODS


We did a post-hoc analysis of the coaching-based implementation of the WHO Safe Childbirth Checklist in Uttar Pradesh. We used multivariable modelling to identify correlations between 30 facility-level characteristics and each health outcome (perinatal mortality, maternal morbidity, or maternal mortality). To identify contexts in which the intervention might have had an effect, we then ran the models on data restricted to the period of intensive coaching and among patients not referred out of the facilities.
FINDINGS


In the multivariable context, perinatal mortality was associated with only 3 of the 30 variables: female literacy at the district level, geographical location, and previous neonatal mortality. Maternal morbidity was only associated with geographical location. No facility-level predictors were associated with maternal mortality. Among facilities in the lowest tertile of birth volume (<95 births per month), our models estimated perinatal mortality was 17 (95% CI 11·7-24·8) per 1000 births in the intervention group versus 38 (31·6-44·8) per 1000 in the control group (p<0·0001).
INTERPRETATION


Mortality was not directly associated with measured facility-level indicators but was associated with general risk factors. The absence of correlation between expected predictors and patient outcomes and the association between improved outcomes and the intervention in smaller facilities suggest a need for additional measures of quality of care that take into account complexity.
FUNDING


Bill & Melinda Gates Foundation.",2019,"In the multivariable context, perinatal mortality was associated with only 3 of the 30 variables: female literacy at the district level, geographical location, and previous neonatal mortality.","['WHO Safe Childbirth Checklist in Uttar Pradesh, India (BetterBirth']",[],"['Maternal morbidity', 'health outcome (perinatal mortality, maternal morbidity, or maternal mortality', 'perinatal mortality, maternal morbidity, or maternal mortality', 'perinatal mortality', 'birth volume', 'maternal mortality']","[{'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0024923', 'cui_str': 'Maternal Mortality'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",95.0,0.067101,"In the multivariable context, perinatal mortality was associated with only 3 of the 30 variables: female literacy at the district level, geographical location, and previous neonatal mortality.","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Marx Delaney', 'Affiliation': 'Ariadne Labs, Boston, MA, USA.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Miller', 'Affiliation': 'Ariadne Labs, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Bobanski', 'Affiliation': 'Ariadne Labs, Boston, MA, USA.'}, {'ForeName': 'Shambhavi', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Community Empowerment Lab, Lucknow, India.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Community Empowerment Lab, Lucknow, India.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Karlage', 'Affiliation': 'Ariadne Labs, Boston, MA, USA.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Tuller', 'Affiliation': 'Ariadne Labs, Boston, MA, USA.'}, {'ForeName': 'Atul A', 'Initials': 'AA', 'LastName': 'Gawande', 'Affiliation': ""Ariadne Labs, Boston, MA, USA; Brigham and Women's Hospital, Boston, MA, USA; Harvard T H Chan School of Public Health, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Katherine E A', 'Initials': 'KEA', 'LastName': 'Semrau', 'Affiliation': ""Ariadne Labs, Boston, MA, USA; Brigham and Women's Hospital, Boston, MA, USA; Harvard T H Chan School of Public Health, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: ksemrau@ariadnelabs.org.""}]",The Lancet. Global health,['10.1016/S2214-109X(19)30261-X']
3487,31103498,Ropivacaine/Fentanyl vs. Bupivacaine/Fentanyl for Pain Control in Children after Thoracic Surgery: A Randomized Study.,"BACKGROUND


Although bupivacaine remains a standard local anesthetic for postoperative epidural infusions in pediatric patients, it is increasingly being replaced with ropivacaine by many anesthesiologists. Ropivacaine is associated with less risk for cardiac and central nervous system toxicity.
AIMS


The purpose of this study was to compare analgesic efficacy and adverse events of postoperative epidural analgesia with ropivacaine/fentanyl versus bupivacaine/fentanyl in children after the Ravitch procedure and thoracotomy.
DESIGN


This was a prospective randomized controlled study.
SETTINGS


This study was conducted at the Department of Thoracic Surgery of the Institute of Tuberculosis and Lung Diseases in Rabka Zdroj, Poland.
PARTICIPANTS/SUBJECTS


94 patients undergoing elective thoracic surgery.
METHODS


Patients aged 7-17 years were randomly allocated into a ropivacaine 0.2% (RF, n = 45) or bupivacaine 0.125% (BF, n = 45) group; 1 mL of each analgesic solution contained 5 μg fentanyl. All patients received acetaminophen and nonsteroidal anti-inflammatory drugs. Nurses assessed pain intensity and incidence of adverse events over 72 hours after surgery and modified analgesia if patient pain intensity was greater than 2 out of 10.
RESULTS


There was no statistically significant difference in median pain scores and incidence of adverse events between the RF group and the BF group. The analgesia was excellent (median pain intensity scores at rest, during deep breathing, and when coughing was less than 1 out of 10 in all patients). Adverse events included incidents of desaturation (64/90), nausea (18/90), vomiting (31/90), pruritus (12/90), urinary retention (2/90), paresthesia (11/90), anisocoria (2/90), and Horner syndrome (2/90).
CONCLUSIONS


Thoracic epidural analgesia using an RF and BF solution resulted in similar pain relief and adverse event profiles.",2019,There was no statistically significant difference in median pain scores and incidence of adverse events between the RF group and the BF group.,"['children after the Ravitch procedure and thoracotomy', 'pediatric patients', 'Children after Thoracic Surgery', 'Department of Thoracic Surgery of the Institute of Tuberculosis and Lung Diseases in Rabka Zdroj, Poland', '94 patients undergoing elective thoracic surgery', 'Patients aged 7-17\xa0years']","['Ropivacaine', 'ropivacaine/fentanyl', 'bupivacaine', 'RF and BF solution', 'ropivacaine', 'Ropivacaine/Fentanyl vs. Bupivacaine/Fentanyl', 'bupivacaine 0.125% (BF, n\xa0=\xa045) group; 1\xa0mL of each analgesic solution contained 5\xa0μg fentanyl', 'bupivacaine/fentanyl', 'acetaminophen and nonsteroidal anti-inflammatory drugs']","['pain relief and adverse event profiles', 'analgesic efficacy', 'incidents of desaturation (64/90), nausea (18/90), vomiting (31/90), pruritus (12/90), urinary retention (2/90), paresthesia (11/90), anisocoria (2/90), and Horner syndrome', 'patient pain intensity', 'median pain scores and incidence of adverse events', 'pain intensity and incidence of adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0003079', 'cui_str': 'Pupil Diameter Unequal'}, {'cui': 'C0019937', 'cui_str': 'Oculosympathetic Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",94.0,0.080933,There was no statistically significant difference in median pain scores and incidence of adverse events between the RF group and the BF group.,"[{'ForeName': 'Lucyna', 'Initials': 'L', 'LastName': 'Tomaszek', 'Affiliation': 'Division of Specialist Nursing, Department of Nursing, Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, Krakow, Poland; Pediatric Division, Department of Thoracic Surgery, Institute for Tuberculosis and Lung Diseases, Rabka-Zdroj, Poland. Electronic address: ltomaszek@igrabka.edu.pl.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Fenikowski', 'Affiliation': 'Pediatric Division, Department of Thoracic Surgery, Institute for Tuberculosis and Lung Diseases, Rabka-Zdroj, Poland.'}, {'ForeName': 'Halina', 'Initials': 'H', 'LastName': 'Komotajtys', 'Affiliation': 'Pediatric Division, Department of Thoracic Surgery, Institute for Tuberculosis and Lung Diseases, Rabka-Zdroj, Poland.'}, {'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Gawron', 'Affiliation': 'Pediatric Division, Department of Thoracic Surgery, Institute for Tuberculosis and Lung Diseases, Rabka-Zdroj, Poland.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2019.02.007']
3488,31752850,Incidence of new-onset diabetes with 1 mg versus 4 mg pitavastatin in patients at high risk of developing diabetes during a 3-year follow-up.,"BACKGROUND


Statin therapy reduces the risk of cardiovascular events across a broad spectrum of patients; however, it increases the risk of new-onset diabetes (NOD). Although the highest dose pitavastatin is considered to not be associated with NOD, there are limited data regarding the impact of long-term highest dose pitavastatin use on the development of NOD in patients at high risk of developing diabetes. Therefore, we prospectively compared the differences in the development of NOD between the lowest and the highest dose of pitavastatin in patients at high risk of developing diabetes during a 3-year follow-up.
METHODS


This post hoc analysis of a prospective, single-blinded, randomized study compared the risk of NOD between the highest dose of pitavastatin (4 mg) and the lowest dose of pitavastatin (1 mg) over a 3-year follow-up in patients with acute coronary syndrome. Among 1044 patients of the original study, 667 patients at high risk of developing type 2 diabetes mellitus were in the subgroup analysis. The primary endpoint was a comparison of the differences in the cumulative incidence of NOD in the pitavastatin 1 mg and 4 mg groups during a 3-year follow-up.
RESULTS


With propensity score matching, there were no significant differences in baseline demographic characteristics between the 2 groups. Incidence of NOD was similar between the pitavastatin 1 mg and 4 mg groups [12 of 289 patients (4.2%) and 8 of 289 patients (2.8%), respectively; p = 0.36]. In a prespecified analysis, there were no significant differences in NOD events according to sex, age, diagnosis, body mass index, glucose intolerance, or dyslipidemia.
CONCLUSIONS


Administration of highest-dose pitavastatin did not increase the risk of NOD in patients at high risk of developing diabetes during the 3-year follow-up. Moreover, various risk factors for NOD such as metabolic syndrome components, glucose intolerance, dyslipidemia, obesity, or hypertension did not affect the development of NOD during pitavastatin administration. Thus, the highest dose pitavastatin can be safely used in patients with metabolic syndrome who are at high risk of developing diabetes. Trial registration Clinical Trial registration information. URL: https://clinicaltrials.gov/ct2/show/NCT02545231. Unique identifier: NCT02545231.",2019,"Incidence of NOD was similar between the pitavastatin 1 mg and 4 mg groups [12 of 289 patients (4.2%) and 8 of 289 patients (2.8%), respectively; p = 0.36].","['patients with metabolic syndrome who are at high risk of developing diabetes', '1044 patients of the original study, 667 patients at high risk of developing type 2 diabetes mellitus', 'patients at high risk of developing diabetes during a 3-year follow-up', 'patients at high risk of developing diabetes', 'patients with acute coronary syndrome']","['URL', 'pitavastatin']","['baseline demographic characteristics', 'cumulative incidence of NOD', 'risk of cardiovascular events', 'glucose intolerance, dyslipidemia, obesity, or hypertension', 'risk of NOD', 'Incidence of new-onset diabetes', 'NOD events according to sex, age, diagnosis, body mass index, glucose intolerance, or dyslipidemia', 'Incidence of NOD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517851', 'cui_str': '667 (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C3541384', 'cui_str': 'Uniform resource locator (foundation metadata concept)'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",1044.0,0.0793499,"Incidence of NOD was similar between the pitavastatin 1 mg and 4 mg groups [12 of 289 patients (4.2%) and 8 of 289 patients (2.8%), respectively; p = 0.36].","[{'ForeName': 'Han Saem', 'Initials': 'HS', 'LastName': 'Jeong', 'Affiliation': ""Heart Diseases Research Institute, Dr. Jeong's Heart Clinic, Jeonju, Republic of Korea.""}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, 126-1, 5ka, Anam-dong, Sungbuk-ku, Seoul, 136-705, Republic of Korea. psyche94@gmail.com.'}, {'ForeName': 'Serhim', 'Initials': 'S', 'LastName': 'Son', 'Affiliation': 'Department of Biostatistics, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Hyonggin', 'Initials': 'H', 'LastName': 'An', 'Affiliation': 'Department of Biostatistics, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Hyungdon', 'Initials': 'H', 'LastName': 'Kook', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, 126-1, 5ka, Anam-dong, Sungbuk-ku, Seoul, 136-705, Republic of Korea.'}, {'ForeName': 'Hyung Joon', 'Initials': 'HJ', 'LastName': 'Joo', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, 126-1, 5ka, Anam-dong, Sungbuk-ku, Seoul, 136-705, Republic of Korea.'}, {'ForeName': 'Jae Hyoung', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, 126-1, 5ka, Anam-dong, Sungbuk-ku, Seoul, 136-705, Republic of Korea.'}, {'ForeName': 'Cheol Woong', 'Initials': 'CW', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, 126-1, 5ka, Anam-dong, Sungbuk-ku, Seoul, 136-705, Republic of Korea.'}, {'ForeName': 'Do-Sun', 'Initials': 'DS', 'LastName': 'Lim', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, 126-1, 5ka, Anam-dong, Sungbuk-ku, Seoul, 136-705, Republic of Korea.'}]",Cardiovascular diabetology,['10.1186/s12933-019-0969-z']
3489,32048788,Acupuncture of different treatment frequency in postprandial distress syndrome: A pilot randomized clinical trial.,"BACKGROUND


The evidence for different frequencies of acupuncture treatment in postprandial distress syndrome (PDS) is insufficient. This study determined whether 3 sessions per week of acupuncture treatment are superior to 1 session per week for symptomatic outcomes in PDS.
METHODS


This 16-week randomized clinical pilot trial was conducted in an outpatient setting in China. Patients with PDS were randomly assigned to receive 3 sessions per week of acupuncture (group H) or 1 session per week of acupuncture (group L) for 4 weeks. The primary outcome was the complete elimination of core symptoms at week 4. Secondary outcomes included overall treatment efficacy, dyspepsia symptoms, quality of life, anxiety, and depression.
KEY RESULTS


Sixty patients were randomized of whom 53 (88.3%) completed this trial. The complete elimination rate of core symptoms was 26.7% (95% CI 12.3%-45.9%) in group H and 10.0% (95% CI 2.1%-26.5%) in group L at week 4 (P = .095). There was a significant difference between H and group L at weeks 8, 12, and 16 (P = .038, .02, and .02). All secondary outcomes were better in group H at all time points. No serious adverse events occurred in either groups.
CONCLUSIONS


This trial showed that acupuncture, at 3 sessions per week, tended to improve symptoms and the quality of life among patients with PDS as compared to once a week. Acupuncture treatment for 4 weeks was feasible and safe. A larger sample, multicenter, randomized controlled trial of acupuncture for PDS appears to be justified in the future.",2020,"There was a significant difference between H and group L at weeks 8, 12, and 16 (P = .038, .02, and .02).","['Sixty patients were randomized of whom 53 (88.3%) completed this trial', 'Patients with PDS', 'postprandial distress syndrome', 'postprandial distress syndrome (PDS', 'outpatient setting in China']","['acupuncture', 'Acupuncture']","['serious adverse events', 'complete elimination of core symptoms', 'overall treatment efficacy, dyspepsia symptoms, quality of life, anxiety, and depression', 'symptoms and the quality of life', 'feasible and safe', 'complete elimination rate of core symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",60.0,0.223066,"There was a significant difference between H and group L at weeks 8, 12, and 16 (P = .038, .02, and .02).","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ya-Quan', 'Initials': 'YQ', 'LastName': 'Hou', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jia-Kai', 'Initials': 'JK', 'LastName': 'Shao', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Na-Na', 'Initials': 'NN', 'LastName': 'Yang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13812']
3490,32058628,Preventing postpartum depressive symptoms using an educational video on infant crying: A cluster randomized controlled trial.,"BACKGROUND


The aim of this study was to examine the impact of watching an educational video on infant crying within 1 week of age after delivery at maternity wards to reduce the prevalence of postpartum depressive symptoms at 1 month after giving birth.
METHODS


The study design was a cluster randomized controlled trial. The intervention hospitals were randomly assigned, stratified by area and function of the hospital. Participants included 47 obstetrics hospitals or clinics out of 150 hospitals or clinics in Osaka Prefecture, Japan. In total, 44 hospitals or clinics completed the trial and 2,601 (intervention group = 1,040, control group = 1,561) caregivers responded to the questionnaire on postpartum depression (response rate: 55.1%). Mothers in the intervention group watched an educational video, within 1 week of age, during hospitalization at maternity wards. Primary outcome in this study was postpartum depression assessed by the Edinburgh Postnatal Depression Scale as 9+ and assessed via questionnaire at a 1-month health checkup.
RESULTS


In the intervention group, 142 (13.7%) mothers reported postpartum depression compared to 250 (16.0%) in the control group. Intention-to-treat analysis showed no significant difference in the prevalence of postpartum depression between the groups. However, among young mothers (<25 years), the analysis showed a 67.0% reduction in postpartum depression (odds ratio: 0.33, 95% CI: 0.15-0.72).
CONCLUSIONS


Watching an educational video on infant crying within 1 week after delivery at maternity wards did not reduce postpartum depression at 1 month after giving birth, but it was effective for young mothers aged <25 years.",2020,"Watching an educational video on infant crying within 1 week after delivery at maternity wards did not reduce postpartum depression at 1 month after giving birth, but it was effective for young mothers aged <25 years.","['young mothers aged <25 years', 'In total, 44 hospitals or clinics completed the trial and 2,601 (intervention group\u2009=\u20091,040, control group\u2009=\u20091,561) caregivers responded to the questionnaire on postpartum depression (response rate: 55.1', 'on infant crying', 'Participants included 47 obstetrics hospitals or clinics out of 150 hospitals or clinics in Osaka Prefecture, Japan', 'infant crying within 1 week of age after delivery at maternity wards to reduce the prevalence of postpartum depressive symptoms at 1 month after giving birth']","['Watching an educational video', 'educational video', 'watching an educational video']","['postpartum depressive symptoms', 'prevalence of postpartum depression', 'postpartum depression assessed by the Edinburgh Postnatal Depression Scale as 9+ and assessed via questionnaire at a 1-month health checkup', 'postpartum depression']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.203418,"Watching an educational video on infant crying within 1 week after delivery at maternity wards did not reduce postpartum depression at 1 month after giving birth, but it was effective for young mothers aged <25 years.","[{'ForeName': 'Satomi', 'Initials': 'S', 'LastName': 'Doi', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Isumi', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Mitsuda', 'Affiliation': 'Department of Maternal Fetal Medicine, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan.'}]",Depression and anxiety,['10.1002/da.23002']
3491,30931761,Unconscious Racial Bias May Affect Dentists' Clinical Decisions on Tooth Restorability: A Randomized Clinical Trial.,"METHODS


In this single-center cross-sectional survey, 57 dentists were given a clinical scenario in combination with a patient's relevant clinical photographs and radiographs depicting either a Black or White patient presenting with a decayed tooth and associated symptoms of irreversible pulpitis. Explicit bias was measured through a questionnaire, which evaluated participants' course of treatment, strength of recommendation, and their perception of patients' dental cooperativeness. Implicit bias was evaluated through brief implicit associate tests.
RESULTS


Recommendation for root canal treatment (RCT) in the White patient condition was significantly higher than in the Black patient condition (χ 2  = 4.77, P < 0.05). Overall, participants were significantly more likely to recommend root canal treatment to White patients (t = 2.46, P = 0.0172) and significantly more likely to recommend extraction for Black patients (t = 3.03, P = 0.0034). In total, 91.23% and 78.95% of all participants displayed high Brief Implicit Association Test race and cooperation scores, respectively, showing a pro-White bias in both categories. This trend was shown to be irrespective of the patient condition.
CONCLUSIONS


Dentists' decision making was affected by the race of the patient, resulting in a greater likelihood of extractions (less RCT) for Black patients presenting with a broken-down tooth and symptoms of irreversible pulpitis.
KNOWLEDGE TRANSFER STATEMENT


The results of this study can be used by clinicians to understand the impact that unconscious racial bias may have on their treatment planning decisions. This information can create awareness, thereby reducing the impact that potential biases can have on the treatment patients receive.",2019,"Overall, participants were significantly more likely to recommend root canal treatment to White patients (t = 2.46, P = 0.0172) and significantly more likely to recommend extraction for Black patients (t = 3.03, P = 0.0034).","['Black patients presenting with a broken-down tooth and symptoms of irreversible pulpitis', 'White patient condition']","['Recommendation for root canal treatment (RCT', ""clinical scenario in combination with a patient's relevant clinical photographs and radiographs depicting either a Black or White patient presenting with a decayed tooth""]","['high Brief Implicit Association Test race and cooperation scores', 'Implicit bias']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0399406', 'cui_str': 'Irreversible pulpitis'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1265875', 'cui_str': 'Disintegration'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]",57.0,0.0581474,"Overall, participants were significantly more likely to recommend root canal treatment to White patients (t = 2.46, P = 0.0172) and significantly more likely to recommend extraction for Black patients (t = 3.03, P = 0.0034).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': '1 Kings College London, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': '1 Kings College London, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cotti', 'Affiliation': '2 Università degli studi di Cagliari, Cagliari, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bardini', 'Affiliation': '2 Università degli studi di Cagliari, Cagliari, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mannocci', 'Affiliation': '1 Kings College London, London, UK.'}]",JDR clinical and translational research,['10.1177/2380084418812886']
3492,31919035,Predictive modelling of the physical demands during training and competition in professional soccer players.,"OBJECTIVES


The present study aimed to predict the cut-off point-values that best differentiate the physical demands of training and competition tasks including friendly matches (FM), small sided games (SSG), large sided games (LSG), mini-goal games (MG) and ball circuit-training (CT) in professional soccer players.
DESIGN


Experimental randomized controlled trial.
METHODS


Fourteen professional players participated in all tasks with the CT, SSG and MG consisting of 8 repetitions of 4-min game play, interspersed by 2-min of active recovery. The training data were compared to the first 32-min of the LSG and two competitive FM per player. All movement patterns from walking to sprint running were recorded using 10Hz GPS devices while player perception of exertion was recorded via a visual analogue scale, post-task. Decision tree induction was applied to the dataset to assess the cut-off point-values from four training drills (SSG, LSG, MG, and CT) and FM for every parameter combination.
RESULTS


Distance covered during jogging (2.3-3.3m/s; >436m), number of decelerations (≤730.5) and accelerations (≤663), and maximum velocity reached (>5.48m/s) characterized the physical demands during competition (FM) with great variability amongst training drills.
CONCLUSION


The use of these novel, cut-off points may aid coaches in the design and use of training drills to accurately prepare athletes for soccer competition.",2020,"The use of these novel, cut-off points may aid coaches in the design and use of training drills to accurately prepare athletes for soccer competition.","['professional soccer players', 'Fourteen professional players participated in all tasks with the']","['CT, SSG and MG consisting of 8 repetitions of 4-min game play, interspersed by 2-min of active recovery', 'training and competition tasks including friendly matches (FM), small sided games (SSG), large sided games (LSG), mini-goal games (MG) and ball circuit-training (CT']","['number of decelerations (≤730.5) and accelerations (≤663), and maximum velocity']","[{'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",14.0,0.0367734,"The use of these novel, cut-off points may aid coaches in the design and use of training drills to accurately prepare athletes for soccer competition.","[{'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Giménez', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain. Electronic address: jesus.gimenezdegalanes@universidadeuropea.es.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Jiménez-Linares', 'Affiliation': 'School Computer Science, Department of Information Technologies and Systems, University of Castilla-la Mancha, Spain.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Leicht', 'Affiliation': 'Sport and Exercise Science, James Cook University, Australia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Gómez', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences, Polytechnic University of Madrid, Spain.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2019.12.008']
3493,29165029,Brief Report: Active Ingredients for Adherence to a Tracker-Based Physical Activity Intervention in Older Adults.,"OBJECTIVES


To identify factors associated with weekly adherence to a 12-week tracker-based activity intervention in older adults.
METHOD


Using generalized linear mixed models in a secondary analysis ( N = 35), we examined factors associated with weekly adherence (defined as wore the Jawbone Up24 tracker for ≥5 days and completed weekly calls). Factors examined included individual characteristics, gave and received virtual support, achieved step goals, barrier and task self-efficacy, and self-comment.
RESULTS


Participants' ( M age  = 61.7, SD age  = 5.7) adherence changed from 86% (Week 1) to 74% (Week 12). Achieved the previous week's goal (β = 1.13, p = .01) and received virtual support (β = 0.01, p = .02) significantly increased the odds of weekly adherence.
DISCUSSION


Achieved step goals and received virtual support were associated with improved adherence to our tracker-based activity intervention, which has promising potential to be translated into the clinical setting to promote active lifestyles.",2019,"Achieved step goals and received virtual support were associated with improved adherence to our tracker-based activity intervention, which has promising potential to be translated into the clinical setting to promote active lifestyles.","[""Participants' ( M age  = 61.7, SD age  = 5.7) adherence changed from 86% (Week 1) to 74% (Week 12"", 'Older Adults', 'older adults']","['Tracker-Based Physical Activity Intervention', 'tracker-based activity intervention']","['odds of weekly adherence', 'step goals, barrier and task self-efficacy, and self-comment']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0282411', 'cui_str': 'Commentary'}]",,0.0154601,"Achieved step goals and received virtual support were associated with improved adherence to our tracker-based activity intervention, which has promising potential to be translated into the clinical setting to promote active lifestyles.","[{'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Swartz', 'Affiliation': '1 The University of Texas Medical Branch, Galveston, USA.'}, {'ForeName': 'Zakkoyya H', 'Initials': 'ZH', 'LastName': 'Lewis', 'Affiliation': '1 The University of Texas Medical Branch, Galveston, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Swartz', 'Affiliation': '3 The University of Texas Health Science Center, Houston, USA.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': '1 The University of Texas Medical Branch, Galveston, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Lyons', 'Affiliation': '1 The University of Texas Medical Branch, Galveston, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464817739350']
3494,31996813,Validation of preferred salt concentration in soup based on a randomized blinded experiment in multiple regions in Japan-influence of umami (L-glutamate) on saltiness and palatability of low-salt solutions.,"Sodium reduction is an important public health goal. Individual and population approaches are necessary for reducing the sodium content of processed foods and meals. The aim of the present study is to affirm the effect of monosodium L-glutamate (MSG), an umami substance, on the saltiness or palatability of low-salt solutions and to explore the preferred salt concentration in soup. Five hundred and eighty-four healthy participants from nineteen regions in Japan tasted 0.3, 0.6, and 0.9% NaCl solutions with or without 0.3% MSG. Evaluations of saltiness and palatability for each solution were conducted using a visual analog scale in a double-blinded randomized manner. Saltiness gradually increased depending on the concentration of NaCl. The saltiness of the 0.3% NaCl solution with MSG was rated significantly higher than that without MSG. The palatability ratings were higher for the solutions with MSG than for those without MSG for all NaCl concentrations. In particular, the palatability rating of the 0.3% NaCl solution with MSG was twice as high as that without MSG and was significantly higher than that of the other five test solutions. Furthermore, these results were observed to be approximately the same, irrespective of sex, age, region, etc. Salt reduction is believed to result in a loss of palatability. However, our results suggest that umami can compensate for the loss of palatability caused by salt reduction and that the addition of an appropriate amount of an umami substance can facilitate salt reduction from 0.9 to 0.3% without sacrificing palatability.",2020,The palatability ratings were higher for the solutions with MSG than for those without MSG for all NaCl concentrations.,"['Five hundred and eighty-four healthy participants from nineteen regions in Japan tasted 0.3, 0.6, and 0.9% NaCl solutions with or without 0.3% MSG', 'multiple regions in Japan-influence of umami (L-glutamate) on saltiness and palatability of low-salt solutions']","['MSG', 'monosodium L-glutamate (MSG']","['palatability ratings', 'concentration of NaCl', 'palatability rating']","[{'cui': 'C4517818', 'cui_str': 'Five hundred and eighty'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C4521594', 'cui_str': 'Senior Chief Petty Officer'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3653289', 'cui_str': 'Salt irrigating solutions'}]","[{'cui': 'C4521594', 'cui_str': 'Senior Chief Petty Officer'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]",584.0,0.0340356,The palatability ratings were higher for the solutions with MSG than for those without MSG for all NaCl concentrations.,"[{'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Hayabuchi', 'Affiliation': ""Department of Food Science and Nutrition, Faculty of Human Life and Environment, Nara Women's University, Nara, Japan. s-hayabuchi@fwu.ac.jp.""}, {'ForeName': 'Rieko', 'Initials': 'R', 'LastName': 'Morita', 'Affiliation': ""Graduate School of Health and Environmental Sciences, Fukuoka Women's University, Fukuoka, Japan.""}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Ohta', 'Affiliation': ""Graduate School of Health and Environmental Sciences, Fukuoka Women's University, Fukuoka, Japan.""}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Nanri', 'Affiliation': ""Graduate School of Health and Environmental Sciences, Fukuoka Women's University, Fukuoka, Japan.""}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co., Inc, Kawasaki, Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Fujitani', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co., Inc, Kawasaki, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co., Inc, Kawasaki, Japan.'}, {'ForeName': 'Sadayoshi', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Division of Nephrology, Endocrinology and Hypertension, Tohoku University Graduate Medicine, Sendai, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Sakima', 'Affiliation': 'Health Administration Center, University of the Ryukyus, Okinawa, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Takase', 'Affiliation': 'Enshu Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Kusaka', 'Affiliation': 'Kusaka Clinic, Kure, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Tsuchihashi', 'Affiliation': 'Steel Memorial Yawata Hospital, Kitakyushu, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-020-0397-1']
3495,32043561,Improving Glycemic Control in African Americans With Diabetes and Mild Cognitive Impairment.,"BACKGROUND/OBJECTIVES


Improving glycemic control in older African Americans with diabetes and mild cognitive impairment (MCI) is important as the population ages and becomes more racially diverse.
DESIGN


Randomized controlled trial.
SETTING


Recruitment from primary care practices of an urban academic medical center. Community-based treatment delivery.
PARTICIPANTS


Older African Americans with MCI, low medication adherence, and poor glycemic control (N = 101).
INTERVENTIONS


Occupational therapy (OT) behavioral intervention and diabetes self-management education.
MEASUREMENTS


The primary outcome was a reduction in hemoglobin A1c level of at least 0.5% at 6 months, with maintenance effects assessed at 12 months.
RESULTS


At 6 months, 25 of 41 (61.0%) OT participants and 22 of 46 (48.2%) diabetes self-management education participants had a reduction in hemoglobin A1c level of at least 0.5%. The model-estimated rates were 58% (95% confidence interval [CI] = 45%-75%) and 48% (95% CI = 36%-64%), respectively (relative risk [RR] = 1.21; 95% CI = 0.84-1.75; P = .31). At 12 months, the respective rates were 21 of 39 (53.8%) OT participants and 24 of 49 (49.0%) diabetes self-management education participants. The model-estimated rates were 50% (95% CI = 37%-68%) and 48% (95% CI = 36%-64%), respectively (RR = 1.05; 95% CI = 0.70-1.57; P = .81).
CONCLUSION


Both interventions improved glycemic control in older African Americans with MCI and poor glycemic control. This result reinforces the American Diabetes Association's recommendation to assess cognition in older persons with diabetes and demonstrates the potential to improve glycemic control in this high-risk population. J Am Geriatr Soc 68:1015-1022, 2020.",2020,"At 12 months, the respective rates were 21 of 39 (53.8%) OT participants and 24 of 49 (49.0%) diabetes self-management education participants.","['older African Americans with MCI and poor glycemic control', 'Recruitment from primary care practices of an urban academic medical center', 'older African Americans with diabetes and mild cognitive impairment (MCI', 'African Americans With Diabetes and Mild Cognitive Impairment', 'Older African Americans with MCI, low medication adherence, and poor glycemic control (N = 101', 'older persons with diabetes']",['Occupational therapy (OT) behavioral intervention and diabetes self-management education'],"['reduction in hemoglobin A1c level', 'respective rates', 'glycemic control', 'hemoglobin A1c level']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control (disorder)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",101.0,0.087014,"At 12 months, the respective rates were 21 of 39 (53.8%) OT participants and 24 of 49 (49.0%) diabetes self-management education participants.","[{'ForeName': 'Barry W', 'Initials': 'BW', 'LastName': 'Rovner', 'Affiliation': 'Departments of Psychiatry and Neurology (BR), Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Casten', 'Affiliation': 'Department of Psychiatry and Human Behavior, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Catherine Verrier', 'Initials': 'CV', 'LastName': 'Piersol', 'Affiliation': 'Department of Occupational Therapy, Jefferson College of Rehabilitation Sciences of Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Neva', 'Initials': 'N', 'LastName': 'White', 'Affiliation': 'Center for Urban Health, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kelley', 'Affiliation': 'Department of Neurology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Leiby', 'Affiliation': 'Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16339']
3496,31361535,"Pemetrexed, Bevacizumab, or the Combination As Maintenance Therapy for Advanced Nonsquamous Non-Small-Cell Lung Cancer: ECOG-ACRIN 5508.","PURPOSE


Pemetrexed or bevacizumab is used for maintenance therapy of advanced nonsquamous non-small-cell lung cancer (NSCLC). The combination of bevacizumab and pemetrexed has also demonstrated efficacy. We conducted a randomized study to determine the optimal maintenance therapy.
PATIENTS AND METHODS


Patients with advanced nonsquamous NSCLC and no prior systemic therapy received carboplatin (area under the curve, 6), paclitaxel (200 mg/m 2 ), and bevacizumab (15 mg/kg) for up to four cycles. Patients without progression after four cycles were randomly assigned to maintenance therapy with bevacizumab (15 mg/kg), pemetrexed (500 mg/m 2 ), or a combination of the two agents. The primary end point was overall survival, with bevacizumab serving as the control group.
RESULTS


Of the 1,516 patients enrolled, 874 (57%) were randomly assigned after induction therapy to one of the three maintenance therapy groups. With a median follow-up of 50.6 months, median survival with pemetrexed was 15.9 months, compared with 14.4 months with bevacizumab (hazard ratio [HR], 0.86;  P  = .12); median survival with pemetrexed and bevacizumab was 16.4 months (HR, 0.9;  P  = .28); median progression-free survival was 4.2, 5.1 (HR, 0.85;  P  = .06), and 7.5 months (HR, 0.67;  P  < .001) for the three groups, respectively. Incidence of worst grade 3 to 4 toxicity was 29%, 37%, and 51%, respectively, for bevacizumab, pemetrexed, and the combination regimen.
CONCLUSION


Single-agent bevacizumab or pemetrexed is efficacious as maintenance therapy for advanced nonsquamous NSCLC. Because of a lack of survival benefit and higher toxicity, the combination of bevacizumab and pemetrexed cannot be recommended.",2019,"Incidence of worst grade 3 to 4 toxicity was 29%, 37%, and 51%, respectively, for bevacizumab, pemetrexed, and the combination regimen.
","['Patients with advanced nonsquamous NSCLC and no prior systemic therapy received', 'advanced nonsquamous NSCLC', 'Patients without progression after four cycles', 'Advanced Nonsquamous Non-Small-Cell Lung Cancer', '1,516 patients enrolled, 874 (57', 'advanced nonsquamous non-small-cell lung cancer (NSCLC']","['bevacizumab and pemetrexed', 'bevacizumab', 'pemetrexed', 'maintenance therapy with bevacizumab', 'Pemetrexed or bevacizumab', 'bevacizumab, pemetrexed', 'bevacizumab or pemetrexed', 'Pemetrexed, Bevacizumab, or the Combination', 'carboplatin (area under the curve, 6), paclitaxel']","['median survival', 'overall survival', ' median progression-free survival', 'survival benefit and higher toxicity', 'Incidence of worst grade 3 to 4 toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",1516.0,0.118515,"Incidence of worst grade 3 to 4 toxicity was 29%, 37%, and 51%, respectively, for bevacizumab, pemetrexed, and the combination regimen.
","[{'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Dahlberg', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Chandra P', 'Initials': 'CP', 'LastName': 'Belani', 'Affiliation': 'Penn State Health Milton S. Hershey Medical Center, Hershey, PA.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Saltzman', 'Affiliation': 'University Hospitals Seidman Cancer Center, Cleveland, OH.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Pennell', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Gopakumar S', 'Initials': 'GS', 'LastName': 'Nambudiri', 'Affiliation': ""St John's Hospital, Maplewood, MN.""}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'McCann', 'Affiliation': 'Baystate Health, Springfield, MA.'}, {'ForeName': 'Jerome D', 'Initials': 'JD', 'LastName': 'Winegarden', 'Affiliation': 'St Joseph Mercy Ann Arbor Hospital, Ann Arbor, MI.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Kassem', 'Affiliation': 'Sinai Cancer Care and Infusion Center, Chicago, IL.'}, {'ForeName': 'Mohamed K', 'Initials': 'MK', 'LastName': 'Mohamed', 'Affiliation': 'Moses H. Cone Memorial Hospital, Greensboro, NC.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Rothman', 'Affiliation': 'Hillman Cancer Center, University Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Lyss', 'Affiliation': 'Missouri Baptist Medical Center, St Louis, MO.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Stinchcombe', 'Affiliation': 'Duke University, Durham, NC.'}, {'ForeName': 'Joan H', 'Initials': 'JH', 'LastName': 'Schiller', 'Affiliation': 'Inova Schar Cancer Center, Fairfax, VA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01006']
3497,31971678,Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids.,"BACKGROUND


Uterine fibroids are hormone-responsive neoplasms that are associated with heavy menstrual bleeding. Elagolix, an oral gonadotropin-releasing hormone antagonist resulting in rapid, reversible suppression of ovarian sex hormones, may reduce fibroid-associated bleeding.
METHODS


We conducted two identical, double-blind, randomized, placebo-controlled, 6-month phase 3 trials (Elaris Uterine Fibroids 1 and 2 [UF-1 and UF-2]) to evaluate the efficacy and safety of elagolix at a dose of 300 mg twice daily with hormonal ""add-back"" therapy (to replace reduced levels of endogenous hormones; in this case, estradiol, 1 mg, and norethindrone acetate, 0.5 mg, once daily) in women with fibroid-associated bleeding. An elagolix-alone group was included to assess the impact of add-back therapy on the hypoestrogenic effects of elagolix. The primary end point was menstrual blood loss of less than 80 ml during the final month of treatment and at least a 50% reduction in menstrual blood loss from baseline to the final month; missing data were imputed with the use of multiple imputation.
RESULTS


A total of 412 women in UF-1 and 378 women in UF-2 underwent randomization, received elagolix or placebo, and were included in the analyses. Criteria for the primary end point were met in 68.5% of 206 women in UF-1 and in 76.5% of 189 women in UF-2 who received elagolix plus add-back therapy, as compared with 8.7% of 102 women and 10% of 94 women, respectively, who received placebo (P<0.001 for both trials). Among the women who received elagolix alone, the primary end point was met in 84.1% of 104 women in UF-1 and in 77% of 95 women in UF-2. Hot flushes (in both trials) and metrorrhagia (in UF-1) occurred significantly more commonly with elagolix plus add-back therapy than with placebo. Hypoestrogenic effects of elagolix, especially decreases in bone mineral density, were attenuated with add-back therapy.
CONCLUSIONS


Elagolix with add-back therapy was effective in reducing heavy menstrual bleeding in women with uterine fibroids. (Funded by AbbVie; Elaris UF-1 and Elaris UF-2 ClinicalTrials.gov numbers, NCT02654054 and NCT02691494.).",2020,"Hypoestrogenic effects of elagolix, especially decreases in bone mineral density, were attenuated with add-back therapy.
","['Women with Uterine Fibroids', '412 women in UF-1 and 378 women in UF-2 underwent randomization, received', '206 women in UF-1 and in 76.5% of 189 women in UF-2 who received', 'women with uterine fibroids', 'women with fibroid-associated bleeding', '104 women in UF-1 and in 77% of 95 women in UF-2']","['Elagolix with add-back therapy', 'elagolix plus add-back therapy', 'norethindrone acetate', 'Elagolix', 'elagolix', 'elagolix or placebo', 'placebo', 'hormonal ""add-back"" therapy', 'elagolix alone']","['levels of endogenous hormones', 'metrorrhagia', 'Hot flushes', 'bone mineral density', 'menstrual blood loss', 'heavy menstrual bleeding']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C2714632', 'cui_str': 'elagolix'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0068980', 'cui_str': 'norethindrone acetate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0025874', 'cui_str': 'Dysfunctional Uterine Bleeding'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood (substance)'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}]",412.0,0.646826,"Hypoestrogenic effects of elagolix, especially decreases in bone mineral density, were attenuated with add-back therapy.
","[{'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Schlaff', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Ronald T', 'Initials': 'RT', 'LastName': 'Ackerman', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Al-Hendy', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Archer', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Linda D', 'Initials': 'LD', 'LastName': 'Bradley', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Carr', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Eve C', 'Initials': 'EC', 'LastName': 'Feinberg', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Hurtado', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'JinHee', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'R Garn', 'Initials': 'RG', 'LastName': 'Mabey', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Charlotte D', 'Initials': 'CD', 'LastName': 'Owens', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Poindexter', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Puscheck', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Rodriguez-Ginorio', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stewart', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Nelson B', 'Initials': 'NB', 'LastName': 'Watts', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}, {'ForeName': 'Ozgul', 'Initials': 'O', 'LastName': 'Muneyyirci-Delale', 'Affiliation': 'From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).'}]",The New England journal of medicine,['10.1056/NEJMoa1904351']
3498,31919012,"Effects of milrinone on renal perfusion, filtration and oxygenation in patients with acute heart failure and low cardiac output early after cardiac surgery.","PURPOSE


Early postoperative heart failure is common after cardiac surgery, and inotrope treatment may impact renal perfusion and oxygenation. We aimed to study the renal effects of the inodilator milrinone when used for the treatment of heart failure after weaning from cardiopulmonary bypass (CPB).
MATERIAL AND METHODS


In 26 patients undergoing cardiac surgery with CPB, we used renal vein catheterization to prospectively measure renal blood flow (RBF), glomerular filtration rate (GFR), and renal oxygenation. Patients who developed acute heart failure and low cardiac output (cardiac index <2.1 L/min/m 2 ) at 30 min after weaning from CPB (n = 7) were given milrinone, and the remaining patients (n = 19) served as controls. Additional measurements were made at 60 min after CPB.
RESULTS


In patients with acute postoperative heart failure, before receiving milrinone, renal blood flow was lower (-33%, p < .05) while renal oxygen extraction was higher (41%, p < .05) compared to the control group. Milrinone increased cardiac index (21%, p < .001), RBF (36%, p < .01) and renal oxygen delivery (35%, p < .01), with no significant change in GFR and oxygen consumption compared to the control group.
CONCLUSIONS


In patients with acute heart failure after weaning from CPB, the milrinone-induced increase in cardiac output was accompanied by improved renal oxygenation.
TRIAL REGISTRATION


ClinicalTrials.gov; identifier NCT02405195, date of registration; March 27, 2015, and NCT02549066, date of registration; 9 September 2015.",2020,"Milrinone increased cardiac index (21%, p < .001), RBF (36%, p < .01) and renal oxygen delivery (35%, p < .01), with no significant change in GFR and oxygen consumption compared to the control group.
","['heart failure after weaning from cardiopulmonary bypass (CPB', 'Patients who developed acute heart failure and low cardiac output', 'patients with acute heart failure and low cardiac output early after cardiac surgery', '26 patients undergoing cardiac surgery with CPB']","['Milrinone', 'inodilator milrinone', 'milrinone']","['renal blood flow (RBF), glomerular filtration rate (GFR), and renal oxygenation', 'renal oxygenation', 'renal oxygen extraction', 'GFR and oxygen consumption', 'RBF', 'renal oxygen delivery', 'cardiac index', 'cardiac output', 'renal perfusion, filtration and oxygenation', 'renal blood flow']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0007166', 'cui_str': 'Low Cardiac Output'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0128513', 'cui_str': 'Milrinone'}]","[{'cui': 'C1527409', 'cui_str': 'Renal blood flow, function (observable entity)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery (observable entity)'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}]",,0.104012,"Milrinone increased cardiac index (21%, p < .001), RBF (36%, p < .01) and renal oxygen delivery (35%, p < .01), with no significant change in GFR and oxygen consumption compared to the control group.
","[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Lannemyr', 'Affiliation': 'All at the Department of Anesthesiology and Intensive Care Medicine at the Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital Gothenburg, S-413 45 Gothenburg, Sweden. Electronic address: lukas.lannemyr@vgregion.se.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Bragadottir', 'Affiliation': 'All at the Department of Anesthesiology and Intensive Care Medicine at the Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital Gothenburg, S-413 45 Gothenburg, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'All at the Department of Anesthesiology and Intensive Care Medicine at the Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital Gothenburg, S-413 45 Gothenburg, Sweden.'}, {'ForeName': 'Sven-Erik', 'Initials': 'SE', 'LastName': 'Ricksten', 'Affiliation': 'All at the Department of Anesthesiology and Intensive Care Medicine at the Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital Gothenburg, S-413 45 Gothenburg, Sweden.'}]",Journal of critical care,['10.1016/j.jcrc.2019.12.022']
3499,32054897,Machine Learning Algorithms for Predicting the Recurrence of Stage IV Colorectal Cancer After Tumor Resection.,"The aim of this study is to explore the feasibility of using machine learning (ML) technology to predict postoperative recurrence risk among stage IV colorectal cancer patients. Four basic ML algorithms were used for prediction-logistic regression, decision tree, GradientBoosting and lightGBM. The research samples were randomly divided into a training group and a testing group at a ratio of 8:2. 999 patients with stage 4 colorectal cancer were included in this study. In the training group, the GradientBoosting model's AUC value was the highest, at 0.881. The Logistic model's AUC value was the lowest, at 0.734. The GradientBoosting model had the highest F1_score (0.912). In the test group, the AUC Logistic model had the lowest AUC value (0.692). The GradientBoosting model's AUC value was 0.734, which can still predict cancer progress. However, the gbm model had the highest AUC value (0.761), and the gbm model had the highest F1_score (0.974). The GradientBoosting model and the gbm model performed better than the other two algorithms. The weight matrix diagram of the GradientBoosting algorithm shows that chemotherapy, age, LogCEA, CEA and anesthesia time were the five most influential risk factors for tumor recurrence. The four machine learning algorithms can each predict the risk of tumor recurrence in patients with stage IV colorectal cancer after surgery. Among them, GradientBoosting and gbm performed best. Moreover, the GradientBoosting weight matrix shows that the five most influential variables accounting for postoperative tumor recurrence are chemotherapy, age, LogCEA, CEA and anesthesia time.",2020,"In the training group, the GradientBoosting model's AUC value was the highest, at 0.881.","['patients with stage IV colorectal cancer after surgery', 'Stage IV Colorectal Cancer', 'stage IV colorectal cancer patients', '999 patients with stage 4 colorectal cancer']","['Machine Learning Algorithms', 'machine learning (ML) technology']",['weight matrix diagram'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0002045'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}]",999.0,0.0140783,"In the training group, the GradientBoosting model's AUC value was the highest, at 0.881.","[{'ForeName': 'Yucan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Henan, China.'}, {'ForeName': 'Lingsha', 'Initials': 'L', 'LastName': 'Ju', 'Affiliation': 'Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Henan, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Tong', 'Affiliation': 'Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Henan, China.'}, {'ForeName': 'Cheng-Mao', 'Initials': 'CM', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Henan, China. zhouchengmao187@foxmail.com.'}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Henan, China. yjyangjj@126.com.'}]",Scientific reports,['10.1038/s41598-020-59115-y']
3500,32056129,"Cladribine Tablets and Relapsing-Remitting Multiple Sclerosis: A Pragmatic, Narrative Review of What Physicians Need to Know.","Immune reconstitution therapy (IRT) is an emerging management concept for multiple sclerosis, whereby a short course of treatment provides long-lasting suppression of disease activity. ""Cladribine tablets 10 mg"" refers to a total cumulative dose of cladribine given over 2 years (henceforth referred to as cladribine tablets 3.5 mg/kg); it is a relatively new treatment option that is hypothesised to act as an IRT acting preferentially on the adaptive immune system. A randomised, 2-year, placebo-controlled trial (CLARITY) showed that treatment with cladribine tablets reduced indices of disease activity (relapses, lesions on magnetic resonance images, disability progression) and that this effect outlasted the pharmacologic effect of the treatment on the immune system (mainly a reduction in circulating B and T cells, with little effect on components of the innate immune system such as monocytes). CLARITY Extension, a 2-year extension to this trial, demonstrated durable efficacy, also in patients who received the standard 2-year course of cladribine tablets 3.5 mg/kg and were re-randomised to placebo for a further 2 years. Relative risk reductions for relapse rate with cladribine tablets 3.5 mg/kg were similar for patients with or without prior high disease activity. Reductions in disability progression with cladribine tablets 3.5 mg/kg were higher in patients with prior high relapse rates with or without prior treatment non-response. In this review, we describe the therapeutic profile of cladribine tablets 3.5 mg/kg and provide practical information on initiating this treatment option in the most appropriate patients.",2020,Reductions in disability progression with cladribine tablets 3.5 mg/kg were higher in patients with prior high relapse rates with or without prior treatment non-response.,['and Relapsing-Remitting Multiple Sclerosis'],"['cladribine tablets', 'Immune reconstitution therapy (IRT', 'placebo', 'Cladribine', 'Cladribine Tablets', 'cladribine']","['disability progression', 'disease activity (relapses, lesions on magnetic resonance images, disability progression']","[{'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}]","[{'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C4505207', 'cui_str': 'Immune Regeneration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",,0.0957267,Reductions in disability progression with cladribine tablets 3.5 mg/kg were higher in patients with prior high relapse rates with or without prior treatment non-response.,"[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'AlJumah', 'Affiliation': 'King Fahad Medical City, Ministry of Health, Riyadh, Kingdom of Saudi Arabia. jumahm@gmail.com.'}, {'ForeName': 'Mona Marwan', 'Initials': 'MM', 'LastName': 'Alkhawajah', 'Affiliation': 'King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Shireen', 'Initials': 'S', 'LastName': 'Qureshi', 'Affiliation': 'Johns Hopkins Aramco Healthcare, Dhahran, Kingdom of Saudi Arabia.'}, {'ForeName': 'Ibtisam', 'Initials': 'I', 'LastName': 'Al-Thubaiti', 'Affiliation': 'King Fahad Military Medical Complex, Dhahran, Kingdom of Saudi Arabia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Ayoub', 'Affiliation': 'King Abdulaziz University, Jeddah, Kingdom of Saudi Arabia.'}, {'ForeName': 'Saeed A', 'Initials': 'SA', 'LastName': 'Bohlega', 'Affiliation': 'King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'Bushnag', 'Affiliation': 'International Medical Center, Jeddah, Kingdom of Saudi Arabia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cupler', 'Affiliation': 'King Faisal Specialist Hospital and Research Center, Jeddah, Kingdom of Saudi Arabia.'}, {'ForeName': 'Abdulkader', 'Initials': 'A', 'LastName': 'Daif', 'Affiliation': 'King Khaled University Hospital, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El Boghdady', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'King Faisal Specialist Hospital and Research Center, Jeddah, Kingdom of Saudi Arabia.'}, {'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Al Malik', 'Affiliation': 'King Saud Bin Abdulaziz University for Health Sciences (KSBU-HS), King Abdulaziz Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Jameelah', 'Initials': 'J', 'LastName': 'Saeedi', 'Affiliation': 'King Abdullah Bin Abdulaziz University Hospital, KAAUH, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Fawzia', 'Initials': 'F', 'LastName': 'Al-Shamrany', 'Affiliation': 'Imam Abdulrahman Bin Faisal University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Eslam', 'Initials': 'E', 'LastName': 'Shosha', 'Affiliation': 'King Khaled Hospital, Al-Majmaah, Kingdom of Saudi Arabia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rieckmann', 'Affiliation': 'Bamberg Hospital and University of Erlangen, Bamberg, Germany.'}]",Neurology and therapy,['10.1007/s40120-020-00177-5']
3501,32039864,The effect of educational intervention on the knowledge and attitude of intensive care nurses in the prevention of pressure ulcers.,"BACKGROUND


Pressure ulcers can cause disability, which can lead to a default in patients' safety and results in frequent complications for patients.
OBJECTIVES


This study aimed to determine the effect of educational intervention on nurses' knowledge and attitude in preventing pressure ulcers.
METHODS


In this study, 67 nurses of ICU wards at Ilam University of Medical Sciences were randomly assigned to the experimental or control group. Data collection tools included the demographic characteristics questionnaire, the Pieper Pressure Ulcer Knowledge test (PUKT) and the Attitude toward Pressure Ulcer tool (APuP). In the experimental group, the nurses were allocated into groups of four-five persons and for each group four face-to-face training sessions and two virtual training sessions by means of educational videos on bed sores were performed. Gathered data were analyzed using SPSS software version 16, and descriptive and analytical tests were performed.
RESULTS


PUKT questionnaire score in the experimental group improved from 15.68 (3.42) to 29.75 (12.33) (P = 0.000), while in the control group it was 16.40 (3.13) and 17.54 (6.62) before intervention, which was not significant (P > 0.05). Furthermore, the APUP questionnaire score in the experimental group improved from 27.12 (2.13) to 39.37 (3.21) (P = 0.000), while in the control group it was 27.65 (1.71) and 28.37 (5.00) before intervention, which was not significant (P > 0.05).
CONCLUSIONS


Since educational intervention improved the knowledge and attitude of nurses in preventing pressure ulcers, it is required to conduct appropriate educational interventions to improve their knowledge and attitude.",2020,"RESULTS


PUKT questionnaire score in the experimental group improved from 15.68 (3.42) to 29.75 (12.33)",['67 nurses of ICU wards at Ilam University of Medical Sciences'],"['virtual training sessions by means of educational videos', 'educational intervention']","['APUP questionnaire score', 'PUKT questionnaire score', 'questionnaires of demographic characteristics, Pieper Pressure Ulcer Knowledge test (PUKT) and Attitude toward Pressure Ulcer tool (APuP']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0050822', 'cui_str': 'ApUp'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",67.0,0.0152738,"RESULTS


PUKT questionnaire score in the experimental group improved from 15.68 (3.42) to 29.75 (12.33)","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Karimian', 'Affiliation': 'Assistant Professor of Vascular Surgery, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Khalighi', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salimi', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Borji', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Tarjoman', 'Affiliation': 'Student Research Committee, Department of Nursing, Faculty of Nursing and Midwifery, Ilam University of Medical Sciences, Ilam, Iran.'}, {'ForeName': 'Yosof', 'Initials': 'Y', 'LastName': 'Mahmoudi', 'Affiliation': 'Student Research Committee, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",The International journal of risk & safety in medicine,['10.3233/JRS-191038']
3502,31831599,Sacral anatomical interspace landmark for lumbar puncture in pregnancy: A randomized trial.,"OBJECTIVE


To determine whether the sacral anatomical interspace landmark (SAIL) technique is more accurate than the classic intercristal line (ICL) technique in pregnant patients and to assess the percentage of clinical determinations above the third lumbar vertebra.
METHODS


In this prospective, randomized, open-label trial, there were 110 singleton pregnant patients with gestational age greater than 37 weeks included. Selection procedure was a convenience sample of pregnant patients who presented for office visits or vaginal or cesarean delivery between March 15 and July 31, 2018, at a single-center obstetric tertiary care university hospital. Both techniques were evaluated by 2 physicians independently assessing each method. Before data collection, we hypothesized that the SAIL technique would be more accurate than the ICL technique in determining the L4-L5 interspace, and that the SAIL technique would produce more estimations below the third lumbar vertebra than the ICL technique. Therefore, the primary outcome was accuracy in identifying the L4-L5 lumbar interspace with SAIL vs ICL. The secondary outcome was difference in clinical assessments above the third lumbar vertebra. Both outcomes were measured via ultrasonography.
RESULTS


Patients were 31 ± 5 years of age (mean ± SD) and had body mass index of 31.8 ± 5.7 kg/m 2  and gestational age of 38.8 ± 1.1 weeks. A total of 110 patients were analyzed. SAIL correctly identified the L4-L5 interspace 49% of the time vs 8% using ICL ( p  < 0.0001). Estimations above L3 were 1% for SAIL vs 31% for ICL ( p  < 0.0001).
CONCLUSIONS


Our study shows improved accuracy in identifying intervertebral space using the SAIL technique; this may prevent direct mechanical trauma to the conus medullaris when lumbar punctures are performed in pregnancy.
CLINICALTRIALSGOV IDENTIFIER


NCT03433612.",2020,"Estimations above L3 were 1% for SAIL vs 31% for ICL ( p  < 0.0001).
","['A total of 110 patients were analyzed', '110 singleton pregnant patients with gestational age greater than 37 weeks included', 'lumbar puncture in pregnancy', 'Patients were 31 ± 5 years of age (mean ± SD) and had body mass index of 31.8 ± 5.7 kg/m 2  and gestational age of 38.8 ± 1.1 weeks', 'pregnant patients who presented for office visits or vaginal or cesarean delivery between March 15 and July 31, 2018, at a single-center obstetric tertiary care university hospital', 'pregnant patients']",['sacral anatomical interspace landmark (SAIL) technique'],['clinical assessments above the third lumbar vertebra'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0553794', 'cui_str': 'Diagnostic lumbar puncture (procedure)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0028900', 'cui_str': 'Office Visits'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0223522', 'cui_str': 'Bone structure of L3 (body structure)'}]",110.0,0.0758897,"Estimations above L3 were 1% for SAIL vs 31% for ICL ( p  < 0.0001).
","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Pancaro', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor. cpancaro@med.umich.edu.'}, {'ForeName': 'Baskar', 'Initials': 'B', 'LastName': 'Rajala', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Christie', 'Initials': 'C', 'LastName': 'Vahabzadeh', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Cassidy', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Thomas T', 'Initials': 'TT', 'LastName': 'Klumpner', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Joanna A', 'Initials': 'JA', 'LastName': 'Kountanis', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'McCabe', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Rector', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Aman', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Keerthana', 'Initials': 'K', 'LastName': 'Sankar', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schoenfeld', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Milo', 'Initials': 'M', 'LastName': 'Engoren', 'Affiliation': 'From the Department of Anesthesiology, University of Michigan, Ann Arbor.'}]",Neurology,['10.1212/WNL.0000000000008749']
3503,32040141,Comparison of Integrated Outpatient Palliative Care With Standard Care in Patients With Parkinson Disease and Related Disorders: A Randomized Clinical Trial.,"Importance


Parkinson disease and related disorders (PDRD) have consequences for quality of life (QoL) and are the 14th leading cause of death in the United States. Despite growing interest in palliative care (PC) for persons with PDRD, few studies are available supporting its effectiveness.
Objective


To determine if outpatient PC is associated with improvements in patient-centered outcomes compared with standard care among patients with PDRD and their caregivers.
Design, Setting, and Participants


This randomized clinical trial enrolled participants at 3 academic tertiary care centers between November 1, 2015, and September 30, 2017, and followed them up for 1 year. A total of 584 persons with PDRD were referred to the study. Of those, 351 persons were excluded by phone and 23 were excluded during in-person screenings. Patients were eligible to participate if they had PDRD and moderate to high PC needs. Patients were excluded if they had urgent PC needs, another diagnosis meriting PC, were already receiving PC, or were unable or unwilling to follow the study protocol. Enrolled participants were assigned to receive standard care plus outpatient integrated PC or standard care alone. Data were analyzed between November 1, 2018, and December 9, 2019.
Interventions


Outpatient integrated PC administered by a neurologist, social worker, chaplain, and nurse using PC checklists, with guidance and selective involvement from a palliative medicine specialist. Standard care was provided by a neurologist and a primary care practitioner.
Main Outcomes and Measures


The primary outcomes were the differences in patient quality of life (QoL; measured by the Quality of Life in Alzheimer Disease scale) and caregiver burden (measured by the Zarit Burden Interview) between the PC intervention and standard care groups at 6 months.
Results


A total of 210 patients with PDRD (135 men [64.3%]; mean [SD] age, 70.1 [8.2] years) and 175 caregivers (128 women [73.1%]; mean [SD] age, 66.1 [11.1] years) were enrolled in the study; 193 participants (91.9%) were white and non-Hispanic. Compared with participants receiving standard care alone at 6 months, participants receiving the PC intervention had better QoL (mean [SD], 0.66 [5.5] improvement vs 0.84 [4.2] worsening; treatment effect estimate, 1.87; 95% CI, 0.47-3.27; P = .009). No significant difference was observed in caregiver burden (mean [SD], 2.3 [5.0] improvement vs 1.2 [5.6] improvement in the standard care group; treatment effect estimate, -1.62; 95% CI, -3.32 to 0.09; P = .06). Other significant differences favoring the PC intervention included nonmotor symptom burden, motor symptom severity, completion of advance directives, caregiver anxiety, and caregiver burden at 12 months. No outcomes favored standard care alone. Secondary analyses suggested that benefits were greater for persons with higher PC needs.
Conclusions and Relevance


Outpatient PC is associated with benefits among patients with PDRD compared with standard care alone. This study supports efforts to integrate PC into PDRD care. The lack of diversity and implementation of PC at experienced centers suggests a need for implementation research in other populations and care settings.
Trial Registration


ClinicalTrials.gov Identifier: NCT02533921.",2020,"Other significant differences favoring the PC intervention included nonmotor symptom burden, motor symptom severity, completion of advance directives, caregiver anxiety, and caregiver burden at 12 months.","['584 persons with PDRD', 'persons with PDRD', 'patients with PDRD and their caregivers', 'patients with PDRD', 'Patients were excluded if they had urgent PC needs, another diagnosis meriting PC, were already receiving PC, or were unable or unwilling to follow the study protocol', 'Patients were eligible to participate if they had PDRD and moderate to high PC needs', 'Patients With Parkinson Disease and Related Disorders', '210 patients with PDRD (135 men [64.3%]; mean [SD] age, 70.1\u2009[8.2] years) and 175 caregivers (128 women [73.1%]; mean [SD] age, 66.1 [11.1] years) were enrolled in the study; 193 participants (91.9', '351 persons were excluded by phone and 23 were excluded during in-person screenings', 'participants at 3 academic tertiary care centers between November 1, 2015, and September 30, 2017, and followed them up for 1 year']","['Integrated Outpatient Palliative Care', 'standard care plus outpatient integrated PC or standard care alone', 'PC intervention']","['nonmotor symptom burden, motor symptom severity, completion of advance directives, caregiver anxiety, and caregiver burden', 'caregiver burden', 'patient quality of life (QoL; measured by the Quality of Life in Alzheimer Disease scale) and caregiver burden (measured by the Zarit Burden Interview']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0222045'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",210.0,0.101226,"Other significant differences favoring the PC intervention included nonmotor symptom burden, motor symptom severity, completion of advance directives, caregiver anxiety, and caregiver burden at 12 months.","[{'ForeName': 'Benzi M', 'Initials': 'BM', 'LastName': 'Kluger', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Miyasaki', 'Affiliation': 'Department of Neurology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Katz', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Galifianakis', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Hall', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pantilat', 'Affiliation': 'Division of Palliative Medicine, Department of Medicine, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Cari', 'Initials': 'C', 'LastName': 'Friedman', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Cernik', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Yuika', 'Initials': 'Y', 'LastName': 'Goto', 'Affiliation': 'Division of Palliative Medicine, Department of Medicine, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Fairclough', 'Affiliation': 'Department of Biostatistics and Informatics, School of Public Health, University of Colorado, Aurora.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sillau', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Kutner', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, School of Medicine, University of Colorado, Aurora.'}]",JAMA neurology,['10.1001/jamaneurol.2019.4992']
3504,32036584,Benefits of exercise in patients with rheumatoid arthritis: a randomized controlled trial of a patient-specific exercise programme.,"BACKGROUND


Patients with rheumatoid arthritis (RA) tend to be more overweight, take less physical exercise, exhibit decreased cardiorespiratory fitness and demonstrate reduced muscle strength compared with age- and sex-matched controls. Impaired cognitive function in RA is an important associated factor, although it has been less well-recognized. The aim of this study was to investigate the effects of a specifically designed exercise programme on body composition, aerobic capacity, muscle strength and cognition in RA.
METHODS


Sixty-six patients with RA were randomized to a specifically designed, personalized exercise programme or standard care. Assessments included body composition, fitness, grip strength and cognitive testing, in addition to disease related measures.
RESULTS


Significant improvements in C-reactive protein (p = 0.025), fatigue scores (p = 0.047) and truncal fat (p = 0.004) were observed in the exercise group compared with controls. Median waist circumference was significantly reduced (94.0 to 91.4 cm, p < 0.0001). Improvements were also seen in aerobic capacity (23.2 to 27.6 ml/kg/min, p = 0.002) and in median right (12.0 to 13.0 kg, p = 0.025) and left grip strength (8.0 to 10 kg, p = 0.005). Cognitive function improved in the exercise group, with median Montreal Cognitive Assessment score 25.5 at 0 months compared to 28.0 at 3 months (p = 0.001).
CONCLUSION


This study demonstrates that exercise has a significant and positive impact on cognitive function in RA. Furthermore, physical activity is safe and effective in chronic inflammatory joint disease and is recommended as a vital component in the holistic management of these patients.Key Points• A dedicated physical exercise programme is feasible and safe in patients with rheumatoid arthritis (RA).• Physical exercise helps reduce fatigue scores and improves cardiovascular fitness in stable RA patients.• Physical exercise has a positive impact on cognition in patients with RA.• A structured exercise programme should be an integral part of chronic disease management protocols for patients with RA.",2020,"RESULTS


Significant improvements in C-reactive protein (p = 0.025), fatigue scores (p = 0.047) and truncal fat (p = 0.004) were observed in the exercise group compared with controls.","['patients with rheumatoid arthritis', 'stable RA patients.•', 'Patients with rheumatoid arthritis (RA', 'patients with RA', 'Sixty-six patients with RA', 'patients with RA.• A']","['exercise programme', 'personalized exercise programme or standard care', 'physical exercise programme', 'exercise', 'structured exercise programme', 'patient-specific exercise programme', 'Physical exercise']","['median right', 'C-reactive protein', 'Cognitive function', 'Median waist circumference', 'left grip strength', 'cardiovascular fitness', 'body composition, aerobic capacity, muscle strength and cognition in RA', 'fatigue scores', 'truncal fat', 'median Montreal Cognitive Assessment score', 'aerobic capacity', 'body composition, fitness, grip strength and cognitive testing, in addition to disease related measures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",66.0,0.033772,"RESULTS


Significant improvements in C-reactive protein (p = 0.025), fatigue scores (p = 0.047) and truncal fat (p = 0.004) were observed in the exercise group compared with controls.","[{'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Azeez', 'Affiliation': ""Department of Rheumatology, St James's Hospital, Dublin, Ireland. mahaazeez@hotmail.com.""}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'Clancy', 'Affiliation': ""Department of Physiotherapy, St. James's Hospital and Trinity College Dublin, Dublin, Ireland.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': ""O'Dwyer"", 'Affiliation': ""Department of Physiotherapy, St. James's Hospital and Trinity College Dublin, Dublin, Ireland.""}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Lahiff', 'Affiliation': ""Department of Rheumatology, St James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Wilson', 'Affiliation': ""Department of Physiotherapy, St. James's Hospital and Trinity College Dublin, Dublin, Ireland.""}, {'ForeName': 'Gaye', 'Initials': 'G', 'LastName': 'Cunnane', 'Affiliation': ""Department of Rheumatology, St James's Hospital, Dublin, Ireland.""}]",Clinical rheumatology,['10.1007/s10067-020-04937-4']
3505,32039955,No Difference in 5-year Clinical or Radiographic Outcomes Between Kinematic and Mechanical Alignment in TKA: A Randomized Controlled Trial.,"BACKGROUND


In kinematic alignment in TKA, the aim is to match the implant's position to the pre-arthritic anatomy of an individual patient, in contrast to the traditional goal of neutral mechanical alignment. However, there are limited mid-term, comparative data for survivorship and functional outcomes for these two techniques.
QUESTIONS/PURPOSES


In the setting of a randomized, controlled trial at 5 years, is there a difference between kinematic alignment and mechanical alignment in TKA in terms of (1) patient-reported outcome measures, (2) survivorship free from revision or reoperation, and (3) the incidence of radiographic aseptic loosening?
METHODS


In the initial study, 99 primary TKAs for osteoarthritis were randomized to either the mechanical alignment (n = 50) or kinematic alignment (n = 49) group. Computer navigation was used in the mechanical alignment group, and patient-specific cutting blocks were used in the kinematic alignment group. At 5 years, 95% (48 of 50) of mechanical alignment and 96% (47 of 49) of kinematic alignment TKAs were available for follow-up. Knee function was assessed using the Knee Society Score (KSS), VAS, Oxford Knee Score (OKS), WOMAC, Forgotten Joint Score (FJS) and EuroQol 5D. Survivorship free from reoperation (any reason) and revision (change or addition of any component) was determined via Kaplan-Meier analysis. Radiographs were assessed for signs of aseptic loosening (as defined by the presence of progressive radiolucent lines in two or more zones) by a single blinded observer.
RESULTS


At 5 years, there were no differences in any patient-reported outcome measure between the two groups. For example, the mean OKS did not differ between the two groups (kinematic alignment: 41.4 ± 7.2 versus mechanical alignment: 41.7 ± 6.3; difference -0.3 [95% confidence interval - 3.2 to 2.5]; p = 0.99). At 5 years, survivorship free from reoperation was 92.2 (95% CI 80.4 to 97.0) for mechanical alignment and 89.7 (95% CI 77.0 to 95.6) for kinematic alignment (log rank test; p = 0.674), survivorship free from revision was 94.1 (95% CI 82.9 to 98.1) for mechanical alignment and 95.9 (95% CI 84.5 to 99.0) for kinematic alignment (log rank test; p = 0.681). At 5 years, one patient demonstrated radiographic aseptic loosening for the mechanical alignment group; no cases were identified for the kinematic alignment group.
CONCLUSIONS


We found no mid-term functional or radiographic differences between TKAs with mechanical alignment or kinematic alignment. The anticipated improvements in patient-reported outcomes with kinematic alignment were not realized. Because kinematic alignment results in a high proportion of patients whose tibial components are inserted in varus, loosening remains a potential long-term concern. Given the unknown impact on long-term survivorship of the substantial alignment alterations with kinematic alignment, our findings do not support the routine use of kinematic alignment outside of a research setting.
LEVEL OF EVIDENCE


Level I, therapeutic study.",2020,"At 5 years, survivorship free from reoperation was 92.2 (95% CI 80.4 to 97.0) for mechanical alignment and 89.7 (95% CI 77.0 to 95.6) for kinematic alignment (log rank test; p = 0.674), survivorship free from revision was 94.1 (95% CI 82.9 to 98.1) for mechanical alignment and 95.9 (95% CI 84.5 to 99.0) for kinematic alignment (log rank test; p = 0.681).","['99 primary TKAs for osteoarthritis', 'TKA']",['mechanical alignment (n = 50) or kinematic alignment'],"['Knee Society Score (KSS), VAS, Oxford Knee Score (OKS), WOMAC, Forgotten Joint Score (FJS) and EuroQol 5D. Survivorship free from reoperation (any reason) and revision (change or addition of any component', 'survivorship free from revision', '5-year Clinical or Radiographic Outcomes', 'survivorship free from reoperation', 'mean OKS', 'Knee function', 'radiographic aseptic loosening', 'signs of aseptic loosening']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0038955'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0333050', 'cui_str': 'Loosening (morphologic abnormality)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}]",99.0,0.152917,"At 5 years, survivorship free from reoperation was 92.2 (95% CI 80.4 to 97.0) for mechanical alignment and 89.7 (95% CI 77.0 to 95.6) for kinematic alignment (log rank test; p = 0.674), survivorship free from revision was 94.1 (95% CI 82.9 to 98.1) for mechanical alignment and 95.9 (95% CI 84.5 to 99.0) for kinematic alignment (log rank test; p = 0.681).","[{'ForeName': 'Simon W', 'Initials': 'SW', 'LastName': 'Young', 'Affiliation': 'S. W. Young, Department of Surgery, University of Auckland, Auckland, New Zealand S. W. Young, M. L. Walker, S. Holland, A. Bayan, B. Farrington, Department of Orthopaedic Surgery, North Shore Hospital, Auckland New Zealand N. P. T. Sullivan, Orthopaedic Department, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Niall P T', 'Initials': 'NPT', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Sherina', 'Initials': 'S', 'LastName': 'Holland', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bayan', 'Affiliation': ''}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Farrington', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001150']
3506,32032096,"Preoperative Cognitive Abnormality, Intraoperative Electroencephalogram Suppression, and Postoperative Delirium: A Mediation Analysis.","BACKGROUND


Postoperative delirium is a common complication that hinders recovery after surgery. Intraoperative electroencephalogram suppression has been linked to postoperative delirium, but it is unknown if this relationship is causal or if electroencephalogram suppression is merely a marker of underlying cognitive abnormalities. The hypothesis of this study was that intraoperative electroencephalogram suppression mediates a nonzero portion of the effect between preoperative abnormal cognition and postoperative delirium.
METHODS


This is a prespecified secondary analysis of the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) randomized trial, which enrolled patients age 60 yr or older undergoing surgery with general anesthesia at a single academic medical center between January 2015 and May 2018. Patients were randomized to electroencephalogram-guided anesthesia or usual care. Preoperative abnormal cognition was defined as a composite of previous delirium, Short Blessed Test cognitive score greater than 4 points, or Eight Item Interview to Differentiate Aging and Dementia score greater than 1 point. Duration of intraoperative electroencephalogram suppression was defined as number of minutes with suppression ratio greater than 1%. Postoperative delirium was detected via Confusion Assessment Method or chart review on postoperative days 1 to 5.
RESULTS


Among 1,113 patients, 430 patients showed evidence of preoperative abnormal cognition. These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001). Of this 17.2% total effect size (99.5% CI, 9.3 to 25.1%), an absolute 2.4% (99.5% CI, 0.6 to 4.8%) was an indirect effect mediated by electroencephalogram suppression, while an absolute 14.8% (99.5% CI, 7.2 to 22.5%) was a direct effect of preoperative abnormal cognition. Randomization to electroencephalogram-guided anesthesia did not change the mediated effect size (P = 0.078 for moderation).
CONCLUSIONS


A small portion of the total effect of preoperative abnormal cognition on postoperative delirium was mediated by electroencephalogram suppression. Study precision was too low to determine if the intervention changed the mediated effect.",2020,"These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001).","['1,113 patients, 430 patients', 'patients with preexisting cognitive impairment', 'enrolled patients age 60 yr or older undergoing surgery with general anesthesia at a single academic medical center between January 2015 and May 2018']","['Intraoperative electroencephalogram suppression', 'Electroencephalography Guidance of Anesthesia', 'electroencephalogram-guided anesthesia or usual care', 'intraoperative electroencephalogram suppression']","['Postoperative delirium', 'Duration of intraoperative electroencephalogram suppression', 'incidence of postoperative delirium', 'Preoperative abnormal cognition', 'preoperative abnormal cognition', 'postoperative delirium', 'Preoperative Cognitive Abnormality, Intraoperative Electroencephalogram Suppression, and Postoperative Delirium']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",,0.120379,"These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001).","[{'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Fritz', 'Affiliation': 'From the Department of Anesthesiology (B.A.F., C.R.K., A.B., A.M.M., T.P.B., J.O., D.P., H.R.M., T.S.W., M.S.A) the Division of Biostatistics (N.L.), Washington University School of Medicine, St. Louis, Missouri the Department of Mathematics and Statistics, Washington University in St. Louis, St. Louis, Missouri (N.L.). Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, University of Manitoba, Winnipeg, Canada Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Occupational Therapy, Washington University School of Medicine, St. Louis, Missouri Department of Occupational Therapy, Washington University School of Medicine, St. Louis, Missouri Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri Department of Surgery, Washington University School of Medicine, St. Louis, Missouri Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Arbi', 'Initials': 'A', 'LastName': 'Ben Abdallah', 'Affiliation': ''}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Mickle', 'Affiliation': ''}, {'ForeName': 'Thaddeus P', 'Initials': 'TP', 'LastName': 'Budelier', 'Affiliation': ''}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Oberhaus', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Maybrier', 'Affiliation': ''}, {'ForeName': 'Troy S', 'Initials': 'TS', 'LastName': 'Wildes', 'Affiliation': ''}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': ''}, {'ForeName': 'Ginika', 'Initials': 'G', 'LastName': 'Apakama', 'Affiliation': ''}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Aranake-Chrisinger', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bolzenius', 'Affiliation': ''}, {'ForeName': 'Jamila', 'Initials': 'J', 'LastName': 'Burton', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Emmert', 'Affiliation': ''}, {'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Goswami', 'Affiliation': ''}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Graetz', 'Affiliation': ''}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Jordan', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kronzer', 'Affiliation': ''}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'McKinnon', 'Affiliation': ''}, {'ForeName': 'Maxwell R', 'Initials': 'MR', 'LastName': 'Muench', 'Affiliation': ''}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Palanca', 'Affiliation': ''}, {'ForeName': 'Aamil', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Spencer', 'Affiliation': ''}, {'ForeName': 'Tracey W', 'Initials': 'TW', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Strutz', 'Affiliation': ''}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tedeschi', 'Affiliation': ''}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Torres', 'Affiliation': ''}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Trammel', 'Affiliation': ''}, {'ForeName': 'Ravi T', 'Initials': 'RT', 'LastName': 'Upadhyayula', 'Affiliation': ''}, {'ForeName': 'Anke C', 'Initials': 'AC', 'LastName': 'Winter', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jacobsohn', 'Affiliation': ''}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Fong', 'Affiliation': ''}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': ''}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Inouye', 'Affiliation': ''}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Schmitt', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Somerville', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stark', 'Affiliation': ''}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': ''}, {'ForeName': 'Spencer J', 'Initials': 'SJ', 'LastName': 'Melby', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Tappenden', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003181']
3507,32037583,Effectiveness of virtual patients in teaching clinical decision-making skills to dental students.,"OBJECTIVES


The aim of this study was to investigate the effect of virtual patient-based training on the clinical decision-making ability of dental students.
METHODS


This quasi-experimental study with pretest and posttest design was conducted on 76 (2015 admitted) dental students of Shiraz Dental School in 2018-2019. The study samples were randomly divided into 2 groups: intervention (web-based virtual patient training = 36) and control (face-to-face case-based training, n = 40). The data collection tools in this study included a questionnaire consisting of 2 sections: demographic information and procedural knowledge. The key-feature test was used to measure procedural knowledge and problem-solving ability in students. Content validity was confirmed by 7 faculty members. Statistical analysis was carried out using SPSS Statistics version 23.0. Descriptive statistics were used to describe the samples, Independent-t test was used to compare the scores between the 2 groups, and repeated measures ANOVA was used to assess the effect of time on the training provided. P < 0.05 was considered as the acceptable significance level.
RESULTS


The mean clinical-decision-making score in the intervention group (11.3 ± 88.88) was more than the control group (8.2 ± 45.54) in Posttest 1 (1 week after intervention), and the difference was statistically significant (P < 0.001). Besides, the scores in the control group (8.2 ± 45.54) rose more significantly than the intervention group (11.3 ± 0.86) in Posttest 2 (1 month after intervention) (P < 0.001).
CONCLUSION


The results of the present research showed that application of virtual patient (VP)-based training can improve learning and clinical decision-making ability of dental students. Moreover, group discussions in physical classrooms should be held alongside VP programs in order to ensure the maximum retention of the topics learned.",2020,"Besides, the scores in the control group (8.2 ± 45.54) rose more significantly than the intervention group (11.3 ± 0.86) in Posttest 2 (1 month after intervention)","['virtual patients in teaching clinical decision-making skills to dental students', '76 (2015 admitted) dental students of Shiraz Dental School in 2018-2019', 'students', 'dental students']","['virtual patient (VP)-based training', 'intervention (web-based virtual patient training\xa0=\xa036) and control (face-to-face case-based training, n\xa0=\xa040', 'virtual patient-based training']","['mean clinical-decision-making score', 'Content validity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0038493', 'cui_str': 'Students, Dental'}, {'cui': 'C0036376', 'cui_str': 'Schools, Dental'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",,0.017891,"Besides, the scores in the control group (8.2 ± 45.54) rose more significantly than the intervention group (11.3 ± 0.86) in Posttest 2 (1 month after intervention)","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mardani', 'Affiliation': 'Oral and Dental Disease Research Center, Department of Oral and Maxillofacial Medicine, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Cheraghian', 'Affiliation': 'School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Soheyl Khaje', 'Initials': 'SK', 'LastName': 'Naeeni', 'Affiliation': 'School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Zarifsanaiey', 'Affiliation': 'Virtual School, and Center of Excellence for e-Learning in Medical Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of dental education,['10.1002/jdd.12045']
3508,32019551,A behavioural change intervention study for the prevention of childhood obesity in South Africa: protocol for a randomized controlled trial.,"BACKGROUND


South Africa is currently undergoing a nutrition transition, and overweight and obesity is on the increase in South African children. Urbanization and other health determinants have led to reduced physical activity and unhealthy eating that have increased the risk of adverse chronic health conditions. This study aims to provide evidence of the effectiveness of a school-based intervention study that targets diet and physical activity for the prevention of child and adolescent overweight and/or obesity.
METHODS


We will employ a mixed method study design which is divided into two phases. Phase 1, namely the qualitative elicitation research phase will inform the development of the quantitative intervention phase (phase 2), consisting of a cluster-randomized trial, based on input from key stakeholders. The study will be undertaken in 16 government-funded primary schools in the iLembe district of KwaZulu-Natal, South Africa. The study will target learners in Grades 4 and 7, their parents, Life Orientation educators, school principals and members of school governing bodies. Assessment for the primary objective (BMI Z scores), and the secondary objectives (change in knowledge, attitudes and behaviours regarding diet and physical activity) in both study arms will be conducted at baseline in March 2020 and at the end of the study in October 2020.
DISCUSSION


The study will be a novel combined mixed methods/RCT design that focuses on diet, physical activity school and family-based interventions in the context of rapidly increasing overweight and obesity prevalence in KwaZulu-Natal. To encourage behaviour change and management of malnutrition, education including diet and physical activity, is an important strategy that must be considered. Nutrition education extends beyond the dissemination of food information; it includes addressing the needs of participants, empowers and encourages decision-making and choice of foods, change in nutrition attitudes, beliefs and influences based on resources available and within cultural boundaries.
TRIAL REGISTRATION


Pan African Clinical Trial Registry PACTR201711002699153. Protocol registered on 16 November 2017.",2020,"Nutrition education extends beyond the dissemination of food information; it includes addressing the needs of participants, empowers and encourages decision-making and choice of foods, change in nutrition attitudes, beliefs and influences based on resources available and within cultural boundaries.
","['Protocol registered on 16 November 2017', '16 government-funded primary schools in the iLembe district of KwaZulu-Natal, South Africa', 'childhood obesity in South Africa', 'South African children', 'learners in Grades 4 and 7, their parents, Life Orientation educators, school principals and members of school governing bodies', 'child and adolescent overweight and/or obesity']",[],"['secondary objectives (change in knowledge, attitudes and behaviours regarding diet and physical activity']","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0454729', 'cui_str': 'Natal (geographic location)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0401925', 'cui_str': 'Teaching principal (occupation)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C4704956', 'cui_str': 'Adolescent Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0751109,"Nutrition education extends beyond the dissemination of food information; it includes addressing the needs of participants, empowers and encourages decision-making and choice of foods, change in nutrition attitudes, beliefs and influences based on resources available and within cultural boundaries.
","[{'ForeName': 'Natisha', 'Initials': 'N', 'LastName': 'Dukhi', 'Affiliation': 'Social Aspects of Public Health, Human Sciences Research Council, Cape Town, South Africa. doctordukhi@gmail.com.'}, {'ForeName': 'Benn', 'Initials': 'B', 'LastName': 'Sartorius', 'Affiliation': 'Discipline of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'Discipline of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}]",BMC public health,['10.1186/s12889-020-8272-1']
3509,32043961,Effect of wearables on sleep in healthy individuals: a randomized crossover trial and validation study.,"STUDY OBJECTIVES


The purpose of this study was to determine whether a wearable sleep-tracker improves perceived sleep quality in healthy participants and to test whether wearables reliably measure sleep quantity and quality compared with polysomnography.
METHODS


This study included a single-center randomized crossover trial of community-based participants without medical conditions or sleep disorders. A wearable device (WHOOP, Inc.) was used that provided feedback regarding sleep information to the participant for 1 week and maintained sleep logs versus 1 week of maintained sleep logs alone. Self-reported daily sleep behaviors were documented in sleep logs. Polysomnography was performed on 1 night when wearing the wearable. The Patient-Reported Outcomes Measurement Information System sleep disturbance sleep scale was measured at baseline, day 7 and day 14 of study participation.
RESULTS


In 32 participants (21 women; 23.8 ± 5 years), wearables improved nighttime sleep quality (Patient-Reported Outcomes Measurement Information System sleep disturbance: B = -1.69; 95% confidence interval, -3.11 to -0.27; P = .021) after adjusting for age, sex, baseline, and order effect. There was a small increase in self-reported daytime naps when wearing the device (B = 3.2; SE, 1.4; P = .023), but total daily sleep remained unchanged (P = .43). The wearable had low bias (13.8 minutes) and precision (17.8 minutes) errors for measuring sleep duration and measured dream sleep and slow wave sleep accurately (intraclass coefficient, 0.74 ± 0.28 and 0.85 ± 0.15, respectively). Bias and precision error for heart rate (bias, -0.17%; precision, 1.5%) and respiratory rate (bias, 1.8%; precision, 6.7%) were very low compared with that measured by electrocardiogram and inductance plethysmography during polysomnography.
CONCLUSIONS


In healthy people, wearables can improve sleep quality and accurately measure sleep and cardiorespiratory variables.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: Assessment of Sleep by WHOOP in Ambulatory Subjects; Identifier: NCT03692195.",2020,"Bias and precision error for heart rate (bias -0.17%; precision 1.5%) and respiratory rate (bias 1.8%, precision 6.7%) were very low when compared to that measured by electrocardiogram and inductance plethysmography during polysomnography.
","['Healthy Individuals', 'healthy subjects', 'community-based participants without medical conditions or sleep disorders']",['wearable sleep-tracker'],"['sleep duration and measured dream sleep and slow wave sleep accurately', 'sleep quantity and quality', 'Bias and precision error for heart rate', 'respiratory rate', 'Self-reported daily sleep behaviors', 'sleep quality', 'nighttime sleep quality (PROMIS sleep disturbance', 'PROMIS Sleep disturbance sleep scale', 'total daily sleep', 'self-reported daytime naps']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}]",,0.0267606,"Bias and precision error for heart rate (bias -0.17%; precision 1.5%) and respiratory rate (bias 1.8%, precision 6.7%) were very low when compared to that measured by electrocardiogram and inductance plethysmography during polysomnography.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Berryhill', 'Affiliation': 'University of Arizona Health Sciences Center for Sleep and Circadian Sciences, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Morton', 'Affiliation': 'University of Arizona Health Sciences Center for Sleep and Circadian Sciences, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'University of Arizona Health Sciences Center for Sleep and Circadian Sciences, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Berryhill', 'Affiliation': 'University of Arizona Health Sciences Center for Sleep and Circadian Sciences, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Provencio-Dean', 'Affiliation': 'University of Arizona Health Sciences Center for Sleep and Circadian Sciences, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Salma I', 'Initials': 'SI', 'LastName': 'Patel', 'Affiliation': 'University of Arizona Health Sciences Center for Sleep and Circadian Sciences, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Estep', 'Affiliation': 'University of Arizona Health Sciences Center for Sleep and Circadian Sciences, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Combs', 'Affiliation': 'University of Arizona Health Sciences Center for Sleep and Circadian Sciences, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Saif', 'Initials': 'S', 'LastName': 'Mashaqi', 'Affiliation': 'University of Arizona Health Sciences Center for Sleep and Circadian Sciences, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Lynn B', 'Initials': 'LB', 'LastName': 'Gerald', 'Affiliation': 'Asthma and Airway Diseases Research Center, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Krishnan', 'Affiliation': 'Breathe Chicago Center, Division of Pulmonary, Critical Care, Sleep, & Allergy, University of Illinois, Chicago, Illinois.'}, {'ForeName': 'Sairam', 'Initials': 'S', 'LastName': 'Parthasarathy', 'Affiliation': 'University of Arizona Health Sciences Center for Sleep and Circadian Sciences, University of Arizona, Tucson, Arizona.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8356']
3510,31930364,Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea in Adults: A Randomized Clinical Trial.,"Importance


RimabotulinumtoxinB (RIMA) may be preferable as an anti-sialorrhea treatment compared with current oral anticholinergic drugs in people with neurological disorders.
Objective


To assess the safety, efficacy, and tolerability of RIMA injections for the treatment of sialorrhea in adults.
Design, Setting, and Participants


This randomized, parallel, double-blind, placebo-controlled clinical trial of RIMA 2500 U and 3500 U was conducted from November 14, 2013, to January 23, 2017. A total of 249 adult patients with troublesome sialorrhea secondary to any disorder or cause were screened. Of them, 13 refused further participation in the study or were lost to follow-up and 49 did not fulfill the criteria for participation; 187 were ultimately enrolled. Patients had to have a minimum unstimulated salivary flow rate (USFR) of 0.2 g/min and a minimum Drooling Frequency and Severity Scale score of 4.
Exposures


Patients were randomized 1:1:1 to RIMA, 2500 U (n = 63); RIMA, 3500 U (n = 64); or placebo (n = 60).
Main Outcomes and Measures


Primary outcomes were the change in USFR from baseline to week 4 and the Clinical Global Impression of Change (CGI-C) at week 4. The CGI-C scores were recorded on a 7-point scale ranging from very much improved to very much worse. Adverse events were recorded throughout the trial period.
Results


Of 187 patients enrolled (147 men [78.6%]; mean [SD] age, 63.9 [13.3] years), 122 patients had Parkinson disease (65.2%), 13 (7.0%) were stroke survivors, 12 had amyotrophic lateral sclerosis (6.4%), 6 had medication-induced sialorrhea (3.2%), 4 had adult cerebral palsy (2.1%), and 30 had sialorrhea owing to other causes (16.0%). A total of 176 completed the study. Treatment with both doses of RIMA significantly reduced USFR at week 4 vs placebo (mean treatment difference, -0.30 g/min [95% CI, -0.39 to -0.21] for both doses vs placebo, P < .001). The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14 [95% CI, -1.49 to -0.80] for 3500 U, both P < .001). Treatment benefits were seen as early as 1 week after injection and were maintained over the treatment cycle of approximately 13 weeks. The RIMA injections were well tolerated compared with placebo. The most common adverse events were self-limited mild to moderate dry mouth, dysphagia, and dental caries.
Conclusions and Relevance


Treatment with RIMA (2500 U and 3500 U) in adults was well tolerated and reduced sialorrhea, with the onset of the effect at 1 week after the injection. These data support the clinical use of RIMA in the management of sialorrhea in adults.
Trial Registration


ClinicalTrials.gov Identifier: NCT01994109.",2020,"The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14","['187 patients enrolled (147 men [78.6%]; mean [SD] age, 63.9 [13.3] years', 'A total of 176 completed the study', '122 patients had Parkinson disease (65.2%), 13 (7.0', 'Sialorrhea in Adults', '249 adult patients with troublesome sialorrhea secondary to any disorder or cause were screened', 'Of them, 13 refused further participation in the study or were lost to follow-up and 49 did not fulfill the criteria for participation; 187 were ultimately enrolled', 'people with neurological disorders', 'sialorrhea in adults']","['RIMA', 'RIMA injections', 'RimabotulinumtoxinB', 'placebo', 'RimabotulinumtoxinB (RIMA']","['adult cerebral palsy', 'amyotrophic lateral sclerosis', 'Safety and Efficacy', 'change in USFR from baseline to week 4 and the Clinical Global Impression of Change (CGI-C', 'tolerated and reduced sialorrhea', 'Adverse events', 'safety, efficacy, and tolerability', 'CGI-C scores', 'USFR', 'minimum Drooling Frequency and Severity Scale score of 4', 'minimum unstimulated salivary flow rate (USFR']","[{'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}]","[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2719430', 'cui_str': 'rimabotulinumtoxinB'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated (qualifier value)'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate (observable entity)'}]",249.0,0.347529,"The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14","[{'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorder Center of Boca Raton, Boca Raton, Florida.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ondo', 'Affiliation': 'Houston Methodist Neurological Institute, Houston, Texas.'}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'The University of Texas Health Science Center, San Antonio.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Trosch', 'Affiliation': 'Franklin Neurology, Farmington Hills, Michigan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Molho', 'Affiliation': ""Parkinson's Disease and Movement Disorder Center, Albany Medical Center, Albany, New York.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lew', 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles.'}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Dashtipour', 'Affiliation': 'Loma Linda University Schools of Medicine and Pharmacy, Loma Linda, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clinch', 'Affiliation': 'US WorldMeds LLC, Louisville, Kentucky.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Espay', 'Affiliation': ""James J. and Joan A. Gardner Family Center for Parkinson's Disease and Movement Disorders, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2019.4565']
3511,32014696,Trainee Performance After Laparoscopic Simulator Training Using a Blackbox versus LapMentor.,"BACKGROUND


Training using laparoscopic high-fidelity simulators (LHFSs) to proficiency levels improves laparoscopic cholecystectomy skills. However, high-cost simulators and their limited availability could negatively impact residents' laparoscopic training opportunities. We aimed to assess whether motivation and surgical skill performance differ after basic skills training (BST) using a low-cost (Blackbox) versus LHFS (LapMentor) among medical students.
MATERIALS AND METHODS


Sixty-three medical students from Karolinska Institutet volunteered, completing written informed consent, questionnaire regarding expectations of the simulation training, and a visuospatial ability test. They were randomized into two groups that received BST using Blackbox (n = 32) or LapMentor (n = 31). However, seven students absence resulted in 56 participants, followed by another 9 dropouts. Subsequently, after training, 47 students took up three consecutive tests using the minimally invasive surgical trainer-virtual reality (MIST-VR) simulator, finalizing a questionnaire.
RESULTS


More Blackbox group participants completed all MIST-VR tests (29/31 versus 18/25). Students anticipated mastering LapMentor would be more difficult than Blackbox (P = 0.04). In those completing the simulation training, a trend toward an increase was noted in how well participants in the Blackbox group liked the simulator training (P = 0.07). Subgroup analysis of motivation and difficulty in liking the training regardless of simulator was found only in women (Blackbox [P = 0.02]; LapMentor [P = 0.06]). In the Blackbox group, the perceived difficulty of training, facilitation, and liking the Blackbox training (significant only in women) were significantly correlated with the students' performance in the MIST-simulator. No such correlations were found in the LapMentor group.
CONCLUSIONS


Results indicate an important role for low-tech/low-cost Blackbox laparoscopic BST of students in an otherwise high-tech surrounding. Furthermore, experience of Blackbox BST procedures correlate with students' performance in the MIST-VR simulator, with some gender-specific differences.",2020,"In those completing the simulation training, a trend toward an increase was noted in how well participants in the Blackbox group liked the simulator training (P = 0.07).","['Sixty-three medical students from Karolinska Institutet volunteered, completing written informed consent, questionnaire regarding expectations of the simulation training, and a visuospatial ability test', '47 students took up three consecutive tests using the', 'medical students']","['minimally invasive surgical trainer-virtual reality (MIST-VR) simulator, finalizing a questionnaire', 'Blackbox versus LapMentor', 'Blackbox', 'Training using laparoscopic high-fidelity simulators (LHFSs', 'basic skills training (BST) using a low-cost (Blackbox) versus LHFS (LapMentor', 'BST using Blackbox', 'LapMentor']","['perceived difficulty of training, facilitation, and liking the Blackbox training', 'MIST-VR tests', 'Trainee Performance']","[{'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",63.0,0.0271268,"In those completing the simulation training, a trend toward an increase was noted in how well participants in the Blackbox group liked the simulator training (P = 0.07).","[{'ForeName': 'Ninos', 'Initials': 'N', 'LastName': 'Oussi', 'Affiliation': 'Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden; Centre for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden; Center for Advanced Medical Simulation and Training, Karolinska University Hospital, Stockholm, Sweden. Electronic address: ninos.oussi@ki.se.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Enochsson', 'Affiliation': 'Center for Advanced Medical Simulation and Training, Karolinska University Hospital, Stockholm, Sweden; Division of Surgery, Department of Surgical and Perioperative Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Henningsohn', 'Affiliation': 'Center for Advanced Medical Simulation and Training, Karolinska University Hospital, Stockholm, Sweden; Division of Urology, CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Castegren', 'Affiliation': 'Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden; Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital, Sweden.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'Medical Physics Laboratory and Simulation Center, Medical School, University of Athens, Athens, Greece.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Kjellin', 'Affiliation': 'Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden; Center for Advanced Medical Simulation and Training, Karolinska University Hospital, Stockholm, Sweden.'}]",The Journal of surgical research,['10.1016/j.jss.2019.12.039']
3512,32019559,Process evaluation of a workplace-based health promotion and exercise cluster-randomised trial to increase productivity and reduce neck pain in office workers: a RE-AIM approach.,"BACKGROUND


This study uses the RE-AIM framework to provide a process evaluation of a workplace-based cluster randomised trial comparing an ergonomic plus exercise intervention to an ergonomic plus health promotion intervention; and to highlight variations across organisations; and consider the implications of the findings for intervention translation.
METHOD


This study applied the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) methodology to examine the interventions' implementation and to explore the extent to which differences between participating organisations contributed to the variations in findings. Qualitative and quantitative data collected from individual participants, research team observations and organisations were interrogated to report on the five RE-AIM domains.
RESULTS


Overall reach was 22.7% but varied across organisations (range 9 to 83%). Participants were generally representative of the recruitment pool though more females (n = 452 or 59%) were recruited than were in the pool (49%). Effectiveness measures (health-related productivity loss and neck pain) varied across all organisations, with no clear pattern emerging to indicate the source of the variation. Organisation-level adoption (66%) and staffing level adoption (91%) were high. The interventions were implemented with minimal protocol variations and high staffing consistency, but organisations varied in their provision of resources (e.g. training space, seniority of liaisons). Mean adherence of participants to the EET intervention was 56% during the intervention period, but varied from 41 to 71% across organisations. At 12 months, 15% of participants reported regular EET adherence. Overall mean (SD) adherence to EHP was 56% (29%) across organisations during the intervention period (range 28 to 77%), with 62% of participants reporting regular adherence at 12 months. No organisations continued the interventions after the follow-up period.
CONCLUSION


Although the study protocol was implemented with high consistency and fidelity, variations in four domains (reach, effectiveness, adoption and implementation) arose between the 14 participating organisations. These variations may be the source of mixed effectiveness across organisations. Factors known to increase the success of workplace interventions, such as strong management support, a visible commitment to employee wellbeing and participant engagement in intervention design should be considered and adequately measured for future interventions.
TRIAL REGISTRATION


ACTRN12612001154897; 29 October 2012.",2020,"Effectiveness measures (health-related productivity loss and neck pain) varied across all organisations, with no clear pattern emerging to indicate the source of the variation.","['Participants were generally representative of the recruitment pool though more females (n\u2009=\u2009452 or 59%) were recruited than were in the pool (49', 'office workers']",['ergonomic plus exercise intervention'],"['neck pain', 'Effectiveness measures (health-related productivity loss and neck pain', 'Mean adherence', 'regular EET adherence', 'Overall mean (SD) adherence to EHP']","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0086246', 'cui_str': 'Ergonomics'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0575092,"Effectiveness measures (health-related productivity loss and neck pain) varied across all organisations, with no clear pattern emerging to indicate the source of the variation.","[{'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Welch', 'Affiliation': 'School of Public Health, The University of Queensland, Brisbane, 4072, Australia. a.welch1@uq.edu.au.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Healy', 'Affiliation': 'School of Public Health, The University of Queensland, Brisbane, 4072, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Straker', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, 6845, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Comans', 'Affiliation': 'Centre for Health Services Research, The University of Queensland, Brisbane, 4072, Australia.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': ""O'Leary"", 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, 4072, Australia.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Melloh', 'Affiliation': 'Institute of Health Sciences, Zurich University of Applied Sciences, 8401, Winterthur, Switzerland.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Sjøgaard', 'Affiliation': 'Department of Sport Sciences and Clinical Biomechanics, Faculty of Health Sciences, University of Southern Denmark, 5230, Odense, Denmark.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Pereira', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, 4072, Australia.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, 4072, Australia.'}, {'ForeName': 'Venerina', 'Initials': 'V', 'LastName': 'Johnston', 'Affiliation': 'RECOVER Injury Research Centre, The University of Queensland, Brisbane, 4072, Australia.'}]",BMC public health,['10.1186/s12889-020-8208-9']
3513,32028455,Footwear and Cadence Affect Gait Variability in Runners with Patellofemoral Pain.,"PURPOSE


To examine the effects of increased cadence and minimalist footwear on lower-limb variability in runners with patellofemoral pain (PFP).
METHODS


Fifteen (12 female, 3 male) runners with PFP ran on an instrumented treadmill with three-dimensional motion capture in three randomly ordered conditions: (i) standard shoe at preferred cadence, (ii) standard shoe +10% cadence, and (iii) minimalist shoe at preferred cadence. Vector coding was used to calculate coordination variability between strides for select lower-limb joint couplings. Approximate entropy was calculated to assess continuous variability for segment kinematic and kinetic data and compared between conditions using repeated-measures ANOVA. One-dimensional statistical parametric mapping repeated-measures ANOVA was performed on the coordination variability data. Cohen's d effect size was calculated for all comparisons.
RESULTS


Larger approximate entropy values (i.e., greater variability) were observed for the standard shoe +10% cadence versus the standard shoe at preferred cadence for hip flexion/extension (P < 0.001; d = 1.12), hip adduction/abduction (P < 0.001; d = 0.99) and ankle dorsiflexion/plantarflexion (P < 0.001; d = 1.37) kinematics, and knee flexion/extension moments (P < 0.001; d = 0.93). Greater variability was also observed in the minimalist shoe versus the standard shoe at preferred cadence for hip internal/external rotation moments (P < 0.001; d = 0.76), knee adduction/abduction moments (P < 0.001; d = 0.51), and knee internal/external rotation moments (P < 0.001; d = 1.02). One-dimensional statistical parametric mapping repeated-measures ANOVA revealed no significant differences in coordination variability between running conditions.
CONCLUSIONS


Greater hip and knee kinematic and kinetic variability observed with either increased cadence or minimalist footwear may be beneficial for those with PFP.",2020,"RESULTS


Larger ApEn values (i.e. greater variability) were observed for the standard shoe +10% cadence versus the standard shoe at preferred cadence for hip flexion/extension (p < 0.001; d = 1.12), hip adduction/abduction (p < 0.001; d = 0.99) and ankle dorsiflexion/plantarflexion (p < 0.001; d = 1.37) kinematics, and knee flexion/extension moments (p < 0.001; d = 0.93).","['Runners with Patellofemoral Pain', 'runners with patellofemoral pain (PFP', 'Fifteen (12 female, 3 male) runners with PFP ran on an']",['instrumented treadmill with 3-dimensional motion capture in three randomly ordered conditions: (i) standard shoe at preferred cadence; (ii) standard shoe +10% cadence; and (iii) minimalist shoe at preferred cadence'],"['ankle dorsiflexion/plantarflexion', 'knee adduction/abduction moments', 'coordination variability', 'hip adduction/abduction', 'Gait Variability', 'knee internal/external rotation moments', 'knee flexion/extension moments', 'Greater variability', 'Greater hip and knee kinematic and kinetic variability']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}]","[{'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0185506', 'cui_str': 'Shoeing'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}]","[{'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231457', 'cui_str': 'Adduction, function (observable entity)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0442222', 'cui_str': 'Internal/external rotation (qualifier value)'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",,0.0382908,"RESULTS


Larger ApEn values (i.e. greater variability) were observed for the standard shoe +10% cadence versus the standard shoe at preferred cadence for hip flexion/extension (p < 0.001; d = 1.12), hip adduction/abduction (p < 0.001; d = 0.99) and ankle dorsiflexion/plantarflexion (p < 0.001; d = 1.37) kinematics, and knee flexion/extension moments (p < 0.001; d = 0.93).","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bonacci', 'Affiliation': 'Centre for Sports Research, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, AUSTRALIA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Fox', 'Affiliation': 'Centre for Sports Research, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, AUSTRALIA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, University of Melbourne, AUSTRALIA.'}, {'ForeName': 'Joel T', 'Initials': 'JT', 'LastName': 'Fuller', 'Affiliation': 'Faculty of Medicine and Health Science, Macquarie University, AUSTRALIA.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'School of Health and Rehabilitation Sciences, Physiotherapy, University of Queensland, AUSTRALIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002267']
3514,32029070,Comparison of upper airway obstruction during zolpidem-induced sleep and propofol-induced sleep in patients with obstructive sleep apnea: a pilot study.,"STUDY OBJECTIVES


Drug-induced sleep endoscopy (DISE) using propofol is commonly used to identify the pharyngeal structure involved in collapse among patients with obstructive sleep apnea. DISE has never been compared with zolpidem-induced sleep endoscopy. We hypothesized that propofol at recommended sedation levels does not influence upper airway collapsibility nor the frequency of multilevel pharyngeal collapse as compared with zolpidem-induced sleep.
METHODS


Twenty-one patients with obstructive sleep apnea underwent polysomnography and sleep endoscopy during zolpidem-induced sleep and during DISE with propofol. A propofol target-controlled infusion was titrated to achieve a bispectral index between 50 and 70. Airway collapsibility was estimated and compared in both conditions by peak inspiratory flow and the magnitude of negative effort dependence. Respiratory drive was estimated by the difference between end-expiratory and peak-negative inspiratory pharyngeal pressure (driving pressure). Site and configuration of pharyngeal collapse during zolpidem-induced sleep and DISE with propofol were compared.
RESULTS


The frequency of multilevel collapse during zolpidem-induced sleep was similar to that observed during DISE with propofol (72% vs 86%, respectively; difference: 14%; 95% confidence interval: -12% to 40%; P = .453). The endoscopic classification of pharyngeal collapse during both conditions were similar. Peak inspiratory flow, respiratory drive (effect size: 0.05 and 0.03, respectively), and negative effort dependence (difference: -6%; 95% confidence interval: -16% to 4%) were also similar in both procedures.
CONCLUSIONS


In this pilot study, recommended propofol doses did not significantly increase multilevel pharyngeal collapse or affect upper airway collapsibility and respiratory drive as compared with zolpidem-induced sleep.
CLINICAL TRIAL REGISTRATION


Registry: clinicaltrials.gov; Name: Natural and Drug Sleep Endoscopy; URL: https://clinicaltrials.gov/ct2/show/study/NCT03004014; Identifier: NCT03004014.",2020,"In this pilot study, recommended propofol doses did not significantly increase multilevel pharyngeal collapse or affect upper airway collapsibility and respiratory drive as compared to zolpidem-induced sleep.","['Patients With Obstructive Sleep Apnea', 'obstructive sleep apnea (OSA) patients']","['Zolpidem-Induced Sleep and Propofol-Induced Sleep', 'polysomnography and sleep endoscopy during zolpidem-induced sleep and during DISE with propofol', 'propofol', 'Upper Airway Obstruction']","['multilevel pharyngeal collapse', 'Respiratory drive', 'Airway collapsibility', 'frequency of multilevel collapse', 'end-expiratory and peak-negative inspiratory pharyngeal pressure (driving pressure', 'Peak inspiratory flow, respiratory drive']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0396283', 'cui_str': 'Sleep nasendoscopy (procedure)'}, {'cui': 'C0740852', 'cui_str': 'Upper airway obstruction'}]","[{'cui': 'C0392748', 'cui_str': 'Collapsed (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",21.0,0.016251,"In this pilot study, recommended propofol doses did not significantly increase multilevel pharyngeal collapse or affect upper airway collapsibility and respiratory drive as compared to zolpidem-induced sleep.","[{'ForeName': 'Alexandre Beraldo', 'Initials': 'AB', 'LastName': 'Ordones', 'Affiliation': 'Department of Otolaryngology, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Gustavo Freitas', 'Initials': 'GF', 'LastName': 'Grad', 'Affiliation': 'Pulmonary Division, Heart Institute (InCor), Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Michel Burihan', 'Initials': 'MB', 'LastName': 'Cahali', 'Affiliation': 'Department of Otolaryngology, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Lorenzi-Filho', 'Affiliation': 'Pulmonary Division, Heart Institute (InCor), Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luiz Ubirajara', 'Initials': 'LU', 'LastName': 'Sennes', 'Affiliation': 'Department of Otolaryngology, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Pedro Rodrigues', 'Initials': 'PR', 'LastName': 'Genta', 'Affiliation': 'Pulmonary Division, Heart Institute (InCor), Universidade de São Paulo, São Paulo, Brazil.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8334']
3515,32031088,Changes in serological bone turnover markers in bisphosphonate induced osteonecrosis of the jaws: A case control study.,"Background


There are a lot study confirmed the relationship of bone serum markers changes and skeletal irregularities. But there is no sufficient case control studies about the role of these markers on bisphosphonate induced osteonecrosis of jaws (BRONJ).
Aims


The aim of this study is to find out if there is any derangement of bone markers in bisphosphonate-treated patients with ONJ.
Methods


We obtained serum bone markers and other relevant endocrine assays on 20 patients with osteonecrosis of the jaw (ONJ) and 20 randomized healthy volunteers. All of the ONJ group treated with zoledronic acid and had been withdrawn from bisphosphonate for at least 6 months. Diagnostic criteria for ONJ were those formulated by the American Association of Oral and Maxillofacial Surgeons. Serum levels of several indices of bone remodeling were evaluated using commercial enzyme-linked immunosorbent assays. The biochemical assays were performed on N-Telopeptides of type I collagen (NTX), bone-specific alkaline phosphatase (ALP), calcitonin, osteocalcin, intact parathyroid hormone (PTH), T3, T4, TSH, and Vitamin D 25 hydroxy (Vit-D).
Results


In ONJ group, PTH level is statistically higher and TSH, Vit-D, osteocalcin and NTX levels statistically lower compared to control group.
Conclusion


We conclude that these changes in PTH, Vit-D, TSH, osteocalcin and NTX levels maybe have a role in the pathophysiology of BRONJ. But the data need to be confirmed by future studies.",2020,"In ONJ group, PTH level is statistically higher and TSH, Vit-D, osteocalcin and NTX levels statistically lower compared to control group.
","['treated patients with ONJ', '20 patients with osteonecrosis of the jaw (ONJ) and 20 randomized healthy volunteers']","['zoledronic acid', 'bisphosphonate']","['Serum levels of several indices of bone remodeling', 'TSH, Vit-D, osteocalcin and NTX levels', 'type I collagen (NTX), bone-specific alkaline phosphatase (ALP), calcitonin, osteocalcin, intact parathyroid hormone (PTH), T3, T4, TSH, and Vitamin D 25 hydroxy (Vit-D']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0073994', 'cui_str': 'calcitonin (salmon synthetic)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]",20.0,0.0386223,"In ONJ group, PTH level is statistically higher and TSH, Vit-D, osteocalcin and NTX levels statistically lower compared to control group.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Demircan', 'Affiliation': 'Department of Dental Prosthetic Technology, Beykent University Vocational School, Beykent, Istanbul, Turkey.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Isler', 'Affiliation': 'Department of Oral Surgery, İstanbul University Faculty of Dentistry, Beykent, Istanbul, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_374_19']
3516,32031091,Postoperative analgesic effect of intrathecal dexmedetomidine on bupivacaine subarachnoid block for open reduction and internal fixation of femoral fractures.,"Background


One of the drawbacks of subarachnoid block is the short duration of analgesia particularly when adjuvants are not added to local anesthetics agent used. However, dexmedetomidine an α 2- adrenergic agent has been found to possess analgesic effect.
Aims


This study seeks to determine the analgesic efficacy of intrathecal 7.5 μg of dexmedetomidine and its side effects when used for open reduction and internal fixation (ORIF) of femoral fractures.
Methodology


It is a prospective randomized, double-blinded study that was carried out in a Nnamdi Azikiwe University Teaching Hospital, Nnewi in Nigeria. Seventy American Society of Anesthesiologists I or II patients were randomized into two groups of 35 each to receive 3 ml of 0.5% hyperbaric bupivacaine combined with either 7.5 μg of dexmedetomidine in 0.3 ml of normal saline (Group D) or 0.3 ml of normal saline alone (Group S). Patient's outcome measures noted (time to first request of analgesia, proportion of patients with pain score <4 postoperatively using numerical rating scale [NRS], and total analgesic consumed in 24 h.).
Results


The patients in Group D had a longer time to first request of analgesia, larger proportion of patients with pain score <4 using NRS in the 2 nd  h postoperatively and lower amount of total analgesic consumed compared to those in Group S. These differences between the two groups were all statistically significant. Furthermore, there was no difference in the incidences of side effects between the two groups (P > 0.05). However, the patient satisfaction was better in Group D.
Conclusion


The addition of 7.5 μg of dexmedetomidine to bupivacaine for subarachnoid block in the management of femoral fractures using ORIF provided better anesthetic profile, particularly prolonged duration of postoperative analgesia without significant side effects.",2020,"Furthermore, there was no difference in the incidences of side effects between the two groups (P > 0.05).","['Seventy American Society of Anesthesiologists', 'Nnamdi Azikiwe University Teaching Hospital, Nnewi in Nigeria']","['bupivacaine', 'dexmedetomidine', '3 ml of 0.5% hyperbaric bupivacaine combined with either 7.5 μg of dexmedetomidine in 0.3 ml of normal saline (Group D) or 0.3 ml of normal saline alone', 'intrathecal dexmedetomidine', 'bupivacaine subarachnoid block']","['time to first request of analgesia, proportion of patients with pain score <4 postoperatively using numerical rating scale [NRS], and total analgesic consumed in 24 h', 'internal fixation of femoral fractures', 'analgesic efficacy', 'patient satisfaction', 'total analgesic', 'longer time to first request of analgesia, larger proportion of patients with pain score', 'incidences of side effects']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0441838', 'cui_str': 'Group D (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",70.0,0.104228,"Furthermore, there was no difference in the incidences of side effects between the two groups (P > 0.05).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nwachukwu', 'Affiliation': 'Department of Anaesthesiology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Anambra State, Nigeria.'}, {'ForeName': 'H O', 'Initials': 'HO', 'LastName': 'Idehen', 'Affiliation': 'Department of Anaesthesiology, University of Benin Teaching Hospital, Benin City, Edo State, Nigeria.'}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Edomwonyi', 'Affiliation': 'Department of Anaesthesiology, University of Benin Teaching Hospital, Benin City, Edo State, Nigeria.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Umeh', 'Affiliation': 'Department of Anaesthesiology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Anambra State, Nigeria.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_142_19']
3517,32028315,Intramedullary Nailing Versus External Fixation in the Treatment of Open Tibial Fractures in Tanzania: Results of a Randomized Clinical Trial.,"BACKGROUND


Open tibial fractures are common injuries in low and middle-income countries, but there is no consensus regarding treatment with intramedullary nailing versus external fixation. The purpose of the present study was to compare the outcomes of initial treatment with intramedullary nailing or external fixation in adults with open tibial fractures.
METHODS


We conducted a randomized clinical trial (RCT) at a tertiary orthopaedic center in Tanzania. Adults with acute diaphyseal open tibial fractures were randomly assigned to statically locked, hand-reamed intramedullary nailing or uniplanar external fixation. The primary outcome was death or reoperation for the treatment of deep infection, nonunion, or malalignment. Secondary outcomes included quality of life as measured with the EuroQol-5 Dimensions (EQ-5D) questionnaire, radiographic alignment, and healing as measured with the modified Radiographic Union Scale for Tibial fractures (mRUST).
RESULTS


Of the 240 patients who were enrolled, 221 (92.1%) (including 111 managed with intramedullary nailing and 110 managed with external fixation) completed 1-year follow-up. There were 44 primary outcome events (with rates of 18.0% and 21.9% in the intramedullary nailing and external fixation groups, respectively) (relative risk [RR] = 0.83 [95% confidence interval (CI), 0.49 to 1.41]; p = 0.505). There was no significant difference between the groups in terms of the rate of deep infection. Intramedullary nailing was associated with a lower risk of coronal malalignment (RR = 0.11 [95% CI, 0.01 to 0.85]; p = 0.01) and sagittal malalignment (RR = 0.17 [95% CI, 0.02 to 1.35]; p = 0.065) at 1 year. The EQ-5D index favored intramedullary nailing at 6 weeks (mean difference [MD] = 0.07 [95% CI = 0.03 to 0.11]; p < 0.001), but this difference dissipated by 1 year. Radiographic healing (mRUST) favored intramedullary nailing at 6 weeks (MD = 1.2 [95% CI = 0.4 to 2.0]; p = 0.005), 12 weeks (MD = 1.0 [95% CI = 0.3 to 1.7]; p = 0.005), and 1 year (MD = 0.8 [95% CI = 0.2 to 1.5]; p = 0.013).
CONCLUSIONS


To our knowledge, the present study is the first RCT assessing intramedullary nailing versus external fixation for the treatment of open tibial fractures in sub-Saharan Africa. Differences in primary events were not detected, and only coronal alignment significantly favored the use of intramedullary nailing.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"Differences in primary events were not detected, and only coronal alignment significantly favored the use of intramedullary nailing.
","['tertiary orthopaedic center in Tanzania', 'open tibial fractures in sub-Saharan Africa', 'Open Tibial Fractures in Tanzania', 'Adults with acute diaphyseal open tibial fractures', '240 patients who were enrolled, 221 (92.1%) (including 111 managed with intramedullary nailing and 110 managed with external fixation) completed 1-year follow-up', 'adults with open tibial fractures']","['Intramedullary nailing', 'Intramedullary Nailing Versus External Fixation', 'intramedullary nailing and external fixation', 'intramedullary nailing', 'intramedullary nailing or external fixation', 'intramedullary nailing versus external fixation', 'statically locked, hand-reamed intramedullary nailing or uniplanar external fixation', 'RCT assessing intramedullary nailing versus external fixation']","['Radiographic healing (mRUST', 'sagittal malalignment', 'death or reoperation for the treatment of deep infection, nonunion, or malalignment', 'lower risk of coronal malalignment', 'EQ-5D index favored intramedullary nailing', 'rate of deep infection', 'quality of life as measured with the EuroQol-5 Dimensions (EQ-5D) questionnaire, radiographic alignment, and healing as measured with the modified Radiographic Union Scale for Tibial fractures (mRUST']","[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0040185', 'cui_str': 'Tibial Fractures'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0443339', 'cui_str': 'Uniplanar (qualifier value)'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0040185', 'cui_str': 'Tibial Fractures'}]",240.0,0.135656,"Differences in primary events were not detected, and only coronal alignment significantly favored the use of intramedullary nailing.
","[{'ForeName': 'Billy T', 'Initials': 'BT', 'LastName': 'Haonga', 'Affiliation': 'Muhimbili Orthopaedic Institute, Muhimbili National Hospital, Dar es Salaam, Tanzania.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Institute for Global Orthopaedics and Traumatology, Department of Orthopaedic Surgery, University of California San Francisco School of Medicine, San Francisco, California.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Albright', 'Affiliation': 'Institute for Global Orthopaedics and Traumatology, Department of Orthopaedic Surgery, University of California San Francisco School of Medicine, San Francisco, California.'}, {'ForeName': 'Sravya T', 'Initials': 'ST', 'LastName': 'Challa', 'Affiliation': 'Institute for Global Orthopaedics and Traumatology, Department of Orthopaedic Surgery, University of California San Francisco School of Medicine, San Francisco, California.'}, {'ForeName': 'Syed H', 'Initials': 'SH', 'LastName': 'Ali', 'Affiliation': 'Institute for Global Orthopaedics and Traumatology, Department of Orthopaedic Surgery, University of California San Francisco School of Medicine, San Francisco, California.'}, {'ForeName': 'Ann A', 'Initials': 'AA', 'LastName': 'Lazar', 'Affiliation': 'Division of Oral Epidemiology, School of Dentistry, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Edmund N', 'Initials': 'EN', 'LastName': 'Eliezer', 'Affiliation': 'Muhimbili Orthopaedic Institute, Muhimbili National Hospital, Dar es Salaam, Tanzania.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Shearer', 'Affiliation': 'Institute for Global Orthopaedics and Traumatology, Department of Orthopaedic Surgery, University of California San Francisco School of Medicine, San Francisco, California.'}, {'ForeName': 'Saam', 'Initials': 'S', 'LastName': 'Morshed', 'Affiliation': 'Institute for Global Orthopaedics and Traumatology, Department of Orthopaedic Surgery, University of California San Francisco School of Medicine, San Francisco, California.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00563']
3518,32026826,Impact of hypertonic saline nebulisation combined with oscillatory positive expiratory pressure on sputum expectoration and related symptoms in cystic fibrosis: a randomised crossover trial.,"OBJECTIVE


To evaluate the impact of combining nebulised hyaluronic acid plus hypertonic saline (HA+HS) with oscillatory positive expiratory pressure (oscillatory-PEP) on sputum expectoration and related symptoms in adults with cystic fibrosis (CF).
DESIGN


Randomised crossover trial.
SETTING


Seven centres.
PARTICIPANTS


Twenty-two outpatients with CF.
INTERVENTIONS


Usual care (HA+HS followed by autogenic drainage) and combined therapy (HA+HS with oscillatory-PEP followed by autogenic drainage]. Each treatment was performed for 5 days.
MAIN OUTCOME MEASURES


Sputum expectoration was measured during the nebulisation period (primary outcome), during autogenic drainage and for 24hours post intervention. The Cough and Sputum Assessment Questionnaire (CASA-Q) and its domains (cough symptoms, cough impact, sputum symptoms and sputum impact), the Leicester Cough Questionnaire (LCQ) and lung function tests were used. Tolerance and patient preference were registered.
RESULTS


Twenty-two participants [mean age 25 (standard deviation 8) years, percentage predicted forced expiratory volume in 1second 67 (22)] were recruited. Combined therapy promoted greater sputum expectoration than usual care during the nebulisation period {median difference 1.8ml [95% confidence interval (CI) 0.2-6.2]}. Both treatments led to similar expectoration during autogenic drainage and for 24hours post intervention. Combined therapy led to a greater improvement in the sputum symptoms domain [6.7 points (95% CI 3.3-13.3] and total CASA-Q score [2.4 points (95% CI 0.1-9.3)] compared with usual care. No differences in LCQ score or lung function were observed. Fewer adverse events were reported using combined therapy, which was selected as the preferred intervention.
CONCLUSIONS


Combined nebulisation increased immediate sputum expectoration, improved sputum symptoms and reduced adverse events compared with usual care in patients with CF.
CLINICAL TRIAL NUMBER


NCT02303808.",2020,Combined therapy promoted greater sputum expectoration than usual care during the nebulisation period {median difference 1.8ml [95% confidence interval (CI) 0.2-6.2]}.,"['Twenty-two participants [mean age 25 (standard deviation 8) years, percentage predicted forced expiratory volume in 1second 67 (22)] were recruited', 'Seven centres', 'cystic fibrosis', 'adults with cystic fibrosis (CF', 'Twenty-two outpatients with CF']","['Usual care (HA+HS followed by autogenic drainage) and combined therapy (HA+HS with oscillatory-PEP followed by autogenic drainage', 'hypertonic saline nebulisation combined with oscillatory positive expiratory pressure', 'nebulised hyaluronic acid plus hypertonic saline (HA+HS) with oscillatory positive expiratory pressure (oscillatory-PEP']","['Cough and Sputum Assessment Questionnaire (CASA-Q) and its domains (cough symptoms, cough impact, sputum symptoms and sputum impact), the Leicester Cough Questionnaire (LCQ) and lung function tests', 'sputum expectoration', 'total CASA-Q score', 'Sputum expectoration', 'LCQ score or lung function', 'sputum symptoms domain', 'adverse events', 'immediate sputum expectoration, improved sputum symptoms and reduced adverse events']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0454507', 'cui_str': 'Autogenic pulmonary drainage'}, {'cui': 'C0033972', 'cui_str': 'Psychotherapy, Multiple'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0425512', 'cui_str': 'Sputum - symptom (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",22.0,0.224361,Combined therapy promoted greater sputum expectoration than usual care during the nebulisation period {median difference 1.8ml [95% confidence interval (CI) 0.2-6.2]}.,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'San Miguel-Pagola', 'Affiliation': 'Universidad San Jorge, Autovía Mudéjar, km. 299, Villanueva de Gállego, 50830, Zaragoza, Spain; Institut de Recherche Expérimentale et Clinique (IREC), Pneumologie, ORL and Dermatologie, Cliniques Universitaires Saint-Luc, Avenue Hippocrate 10, Woluwe-Saint-Lambert, 1200, Brussels, Belgium. Electronic address: msanmiguelpagola@gmail.com.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Pneumologie, ORL and Dermatologie, Cliniques Universitaires Saint-Luc, Avenue Hippocrate 10, Woluwe-Saint-Lambert, 1200, Brussels, Belgium; Service de Pneumologie, Cliniques Universitaires Saint-Luc, Avenue Hippocrate 10, Woluwe-Saint-Lambert, 1200, Brussels, Belgium. Electronic address: gregory.reychler@uclouvain.be.'}, {'ForeName': 'María A', 'Initials': 'MA', 'LastName': 'Cebrià I Iranzo', 'Affiliation': 'Department of Physiotherapy, Universitat de València, Av. de Blasco Ibáñez, 13, 46010, Valencia, Spain; Physiotherapy, Cardiorespiratory Rehabilitation Service, Hospital Universitari i Politècnic La Fe, Avinguda de Fernando Abril Martorell, 106, 46026, Valencia, Cáceres, Spain. Electronic address: Angeles.Cebria@uv.es.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Gómez-Romero', 'Affiliation': 'Physiotherapy, Cystic Fibrosis Association, Carrera 8, bajo, 10002, Cáceres, Extremadura, Spain. Electronic address: margomrom@hotmail.com.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Díaz-Gutiérrez', 'Affiliation': 'Physiotherapy, Virgen del Rocío Hospital, Avda. Manuel Siurot, s/n, 41013, Sevilla, Spain. Electronic address: ferdigu@hotmail.com.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Herrero-Cortina', 'Affiliation': 'Universidad San Jorge, Autovía Mudéjar, km. 299, Villanueva de Gállego, 50830, Zaragoza, Spain. Electronic address: beafisiorespi@gmail.com.'}]",Physiotherapy,['10.1016/j.physio.2019.11.001']
3519,32026820,Telerehabilitation is non-inferior to usual care following total hip replacement - a randomized controlled non-inferiority trial.,"OBJECTIVES


Determine if outpatient physiotherapy care via telerehabilitation is as effective as in-person physiotherapy care after total hip replacement.
DESIGN


Randomised, single-blind, controlled, non-inferiority clinical trial.
SETTING


QEII Jubilee Hospital, Brisbane, Australia.
PARTICIPANTS


Seventy patients receiving a total hip replacement entered the study, sixty-nine completed the study.
INTERVENTIONS


The control group (n=35; x¯ age 67; female 60%) received in-person outpatient physiotherapy and a paper-based home exercise programme. The intervention group (n=35; x¯ age 62; female 66%) received remotely delivered telerehabilitation directly into their homes and a technology-based home exercise program using an iPad application.
MAIN OUTCOME MEASURES


The primary outcome was the quality of life subscale of the Hip disability and Osteoarthritis Outcome Score measured at six weeks post-operatively. Secondary outcomes included objective strength and balance outcomes, self-reported function and satisfaction outcomes, and home exercise program compliance.
RESULTS


No between group difference was detected in the Hip disability and Osteoarthritis Outcome Score quality of life subscale at the primary end point of six weeks (P=0.970). Strength, balance and self-reported function showed no between group differences. Overall satisfaction was high across both groups, with the intervention group scoring higher for ease of attending appointments (intervention 95 (10), control 86 (18), mean difference 9 (95% CI 2 to 16), P=0.017. The intervention group were more compliant with their home exercise programme (intervention 86% (20%), control 74% (26%), mean difference 12% (95% CI 1% to 23%), P=0.048).
CONCLUSIONS


Telerehabilitation programmes can be delivered to total hip replacement patients in their own homes, using readily available technology while maintaining high levels of satisfaction. More importantly, telerehabilitation patients appear to achieve non-inferior physical and functional outcomes as those receiving in-person rehabilitation programmes.
TRIAL REGISTRATION


ACTRN12615000824561. (Australian New Zealand Clinical Trials Registry).",2020,No between group difference was detected in the Hip disability and Osteoarthritis Outcome Score quality of life subscale at the primary end point of six weeks (P=0.970).,"['Seventy patients receiving a total hip replacement entered the study, sixty-nine completed the study', 'person physiotherapy care after total hip replacement', 'QEII Jubilee Hospital, Brisbane, Australia', 'The intervention group (n=35; x¯ age 62; female 66%) received']","['person outpatient physiotherapy and a paper-based home exercise programme', 'compliant with their home exercise programme', 'remotely delivered telerehabilitation directly into their homes and a technology-based home exercise program using an iPad application']","['Hip disability and Osteoarthritis Outcome Score quality of life subscale', 'Overall satisfaction', 'objective strength and balance outcomes, self-reported function and satisfaction outcomes, and home exercise program compliance', 'quality of life subscale of the Hip disability and Osteoarthritis Outcome Score', 'Strength, balance and self-reported function']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0566588', 'cui_str': 'Compliant (qualifier value)'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C2960679', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.126545,No between group difference was detected in the Hip disability and Osteoarthritis Outcome Score quality of life subscale at the primary end point of six weeks (P=0.970).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'QEII Jubilee Hospital, Metro South Hospital and Health Service, Brisbane, Australia. Electronic address: mark.nelson@health.qld.gov.au.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bourke', 'Affiliation': 'Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia. Electronic address: m.bourke@uq.edu.au.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Crossley', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, College of Science, Health and Engineering, Melbourne, Australia. Electronic address: k.crossley@latrobe.edu.au.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Russell', 'Affiliation': 'Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia. Electronic address: t.russell@uq.edu.au.'}]",Physiotherapy,['10.1016/j.physio.2019.06.006']
3520,32026839,"Volume of water added to crushed ice affects the efficacy of cryotherapy: a randomised, single-blind, crossover trial.","OBJECTIVE


To compare the effects of different cryotherapeutic preparations.
DESIGN


Randomised, single-blind, crossover trial.
SETTING


University laboratory.
PARTICIPANTS


Sixteen healthy women.
INTERVENTIONS


Participants were randomised to receive three cryotherapeutic preparations: pure ice (500g), watered ice (500g of ice in 500ml of water) and wetted ice (500g of ice in 50ml of water).
MAIN OUTCOME MEASURES


The primary outcome was skin surface temperature after cryotherapy, measured at the central point of application, and the minimum temperature of the region of interest (ROI). The secondary outcome was the surface area cooled to <13.6°C, which is the recommended temperature to achieve therapeutic effects.
RESULTS


After application of ice, mean skin surface temperature at the central point was 4.6 [standard deviation (SD) 1.9] °C for the pure ice preparation, 4.9 (SD 2.5) °C for the wetted ice preparation, and 9.6 (SD 1.8) °C for the watered ice preparation. When compared with the watered ice preparation, this represented a mean difference (MD) of 5.0°C for the pure ice preparation [95% confidence interval (CI) 4.0 to 6.0; P<0.001] and an MD of 4.7°C for the wetted ice preparation (95% CI 2.5 to 6.8; P<0.001). The minimum temperatures in the ROI were also lower for the pure ice preparation 3.0 (SD 0.9) °C and the wetted ice preparation 2.8 (SD 0.6) °C than the watered ice preparation 7.9 (SD 1.5) °C. This represented an MD of 4.8°C for the pure ice preparation (95% CI 4.0 to 5.7; P<0.001) and 5.1°C for the wetted ice preparation (95% CI 4.0 to 6.2; P<0.001].
CONCLUSIONS


Application of pure ice or wetted ice led to a greater decrease in skin surface temperature compared with watered ice. For clinical purposes, combining equal parts of water and ice could decrease this effect.
CLINICAL TRIAL REGISTRATION NUMBER


Clinicaltrials.gov (NCT03414346).",2020,"CONCLUSIONS


Application of pure ice or wetted ice led to a greater decrease in skin surface temperature compared with watered ice.","['University laboratory', 'Sixteen healthy women']","['cryotherapy', 'cryotherapeutic preparations: pure ice (500g), watered ice (500g of ice in 500ml of water) and wetted ice (500g of ice in 50ml of water']","['skin surface temperature after cryotherapy, measured at the central point of application, and the minimum temperature of the region of interest (ROI', 'skin surface temperature', 'mean skin surface temperature', 'therapeutic effects']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0349714', 'cui_str': 'Icing (substance)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1527144'}]",16.0,0.2698,"CONCLUSIONS


Application of pure ice or wetted ice led to a greater decrease in skin surface temperature compared with watered ice.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'de Estéfani', 'Affiliation': 'Aging, Resources and Rheumatology Laboratory, Federal University of Santa Catarina, Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ruschel', 'Affiliation': 'Health and Sports Science Centre, Santa Catarina State University, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Inaihá Laureano', 'Initials': 'IL', 'LastName': 'Benincá', 'Affiliation': 'Aging, Resources and Rheumatology Laboratory, Federal University of Santa Catarina, Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Daniela Pacheco', 'Initials': 'DP', 'LastName': 'Dos Santos Haupenthal', 'Affiliation': 'Laboratory of Cellular and Molecular Biology, University of the Extreme South of Santa Catarina, Criciuma, Santa Catarina, Brazil.'}, {'ForeName': 'Núbia Carelli Pereira', 'Initials': 'NCP', 'LastName': 'de Avelar', 'Affiliation': 'Aging, Resources and Rheumatology Laboratory, Federal University of Santa Catarina, Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Haupenthal', 'Affiliation': 'Aging, Resources and Rheumatology Laboratory, Federal University of Santa Catarina, Araranguá, Santa Catarina, Brazil. Electronic address: alessandro.haupenthal@ufsc.br.'}]",Physiotherapy,['10.1016/j.physio.2019.12.005']
3521,32024584,Effects on obstructive sleep apnea severity following a tailored behavioral sleep medicine intervention aimed at increased physical activity and sound eating: an 18-month follow-up of a randomized controlled trial.,"STUDY OBJECTIVES


Positive effects have been reported following a behavioral sleep medicine (BSM) intervention targeting physical activity and eating behavior in addition to continuous positive airway pressure (CPAP) treatment in patients with obstructive sleep apnea (OSA). Long-term follow-up remains to be explored. The aim was to examine the long-term effects of a tailored BSM intervention addressing physical activity and eating behavior in addition to CPAP treatment in patients with moderate to severe OSA combined with overweight and physical inactivity. Further, the aim was to identify variables at baseline, associated with treatment success regarding OSA severity.
METHODS


Sixty participants (body mass index: 34.5 ± 5.0 kg/m²; apnea-hypopnea index [AHI]: 43.7 ± 21.2 events/h) completed the randomized controlled trial with a follow-up at 18 months. The participants were randomized to either a control group treated with CPAP or an experimental group treated with CPAP and a BSM intervention targeting physical activity and eating behavior changes. OSA was categorized as mild (AHI: 5 to <14.9 events/h), moderate (AHI: 15 to <29.9 events/h), or severe (AHI ≥30 events/h).
RESULTS


Being in the experimental group was associated with a larger improvement (B = -9.353, P = .029) in AHI at the 18-month follow-up compared with being in the control group when adjusting for baseline AHI and body mass index. Improvement in OSA category occurred more frequently in the experimental group participants (n = 11; 36.7%) compared with the control group (n = 2; 6.7%). Deterioration in OSA category was found in 1 (3.3%) participant in the experimental group and 3 (10%) in the control group.
CONCLUSIONS


The importance of a BSM intervention as an adjunct treatment in patients with OSA is emphasized due to its long-term benefits.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: Lifestyle changes in obstructive sleep apnea; Identifier: NCT01102920.",2020,"RESULTS


Being in the experimental group was associated with a larger improvement (B=-9.353 p=0.029) in AHI at the 18-month follow-up compared with being in the control group when adjusting for baseline AHI and BMI.","['Sixty participants (BMI 34.5 +5.0, AHI 43.7 +21.2', 'patients with moderate to severe OSA combined with overweight and physical inactivity', 'patients with OSA', 'patients with obstructive sleep apnoea (OSA']","['BSM intervention', 'tailored behavioural sleep medicine intervention', 'control group treated with CPAP', 'tailored BSM intervention', 'behavioural sleep medicine (BSM) intervention', 'CPAP and a BSM intervention', 'continuous positive airway preassure (CPAP) treatment']","['obstructive sleep apnoea severity', 'Deterioration in OSA category', 'OSA', 'OSA category', 'physical activity and sound eating']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C4304028', 'cui_str': 'Sleep medicine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",60.0,0.0665526,"RESULTS


Being in the experimental group was associated with a larger improvement (B=-9.353 p=0.029) in AHI at the 18-month follow-up compared with being in the control group when adjusting for baseline AHI and BMI.","[{'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Spörndly-Nees', 'Affiliation': 'Department of Neuroscience, Physiotherapy, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Åsenlöf', 'Affiliation': 'Department of Neuroscience, Physiotherapy, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lindberg', 'Affiliation': 'Department of Medical Sciences, Respiratory, Allergy, and Sleep Research, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Emtner', 'Affiliation': 'Department of Neuroscience, Physiotherapy, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Igelström', 'Affiliation': 'Department of Neuroscience, Physiotherapy, Uppsala University, Uppsala, Sweden.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8322']
3522,30076614,Terlipressin Is Superior to Noradrenaline in the Management of Acute Kidney Injury in Acute on Chronic Liver Failure.,"Hepatorenal syndrome (HRS) carries a high short-term mortality in patients with cirrhosis and acute on chronic liver failure (ACLF). Terlipressin and noradrenaline are routinely used in cirrhosis with HRS and have been found to be equally effective. There are no data comparing the efficacy of terlipressin with noradrenaline in ACLF patients with HRS. In an open-label, randomized controlled trial (RCT), consecutive patients with ACLF diagnosed with HRS acute kidney injury (AKI) were randomized to albumin with infusion of terlipressin (2-12 mg/day; n = 60) or noradrenaline (0.5-3.0 mg/h; n = 60). Response to treatment, course of AKI, and outcome were studied. Baseline characteristics, including AKI stage and sepsis-related HRS-AKI, were comparable between groups. Compared to noradrenaline, terlipressin achieved greater day 4 (26.1% vs. 11.7%; P = 0.03) and day 7 (41.7% vs. 20%; P = 0.01) response. Reversal of HRS was also better with terlipressin (40% vs. 16.7%; P = 0.004), with a significant reduction in the requirement of renal replacement therapy (RRT; 56.6% vs. 80%; P = 0.006) and improved 28-day survival (48.3% vs. 20%; P = 0.001). Adverse events limiting use of drugs were higher with terlipressin than noradrenaline (23.3% vs. 8.3%; P = 0.02), but were reversible. On multivariate analysis, high Model for End-Stage Liver Disease (MELD; odds ratio [OR], 1.10; confidence interval [CI] = 1.009-1.20; P = 0.03) and noradrenaline compared to terlipressin (OR, 3.05; CI = 1.27-7.33; P = 0.01) predicted nonresponse to therapy. Use of noradrenaline compared to terlipressin was also predictive of higher mortality (hazard ratio [HR], 2.08; CI = 1.32-3.30; P = 0.002). Conclusion: AKI in ACLF carries a high mortality. Infusion of terlipressin gives earlier and higher response than noradrenaline, with improved survival in ACLF patients with HRS-AKI.",2020,"Infusion of terlipressin gives earlier and higher response than noradrenaline, with improved survival in ACLF patients with HRS-AKI.","['ACLF patients with HRS-AKI', 'Acute Kidney Injury in Acute on Chronic Liver Failure', 'patients with cirrhosis and acute on chronic liver failure (ACLF', 'ACLF patients with HRS', 'consecutive patients with ACLF diagnosed with HRS acute kidney injury (AKI']","['albumin with infusion of terlipressin', 'terlipressin', 'ACLF', 'Terlipressin and noradrenaline', 'noradrenaline', 'Terlipressin', 'Noradrenaline']","['survival', 'requirement of renal replacement therapy', 'Reversal of HRS', '28-day survival', 'Hepatorenal syndrome (HRS', 'AKI stage and sepsis-related HRS-AKI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C3850141', 'cui_str': 'Acute-On-Chronic Liver Failure (ACLF)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]","[{'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0145185', 'cui_str': 'terlipressin'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019212', 'cui_str': 'Hepatorenal Syndrome'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.192818,"Infusion of terlipressin gives earlier and higher response than noradrenaline, with improved survival in ACLF patients with HRS-AKI.","[{'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Arora', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Rakhi', 'Initials': 'R', 'LastName': 'Maiwall', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Vijayaraghavan', 'Initials': 'V', 'LastName': 'Rajan', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Jindal', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Saggere', 'Initials': 'S', 'LastName': 'Muralikrishna Shasthry', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Guresh', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Department of Clinical Research and Biostatistics, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Jain', 'Affiliation': 'Department of Clinical Research and Biostatistics, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Shiv Kumar', 'Initials': 'SK', 'LastName': 'Sarin', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30208']
3523,32026829,"""WALK30X5"": a feasibility study of a physiotherapy walking programme for people with mild to moderate musculoskeletal conditions.","OBJECTIVES


To explore the feasibility of delivering and evaluating a web-based walking intervention for people with long term musculoskeletal conditions (LTMCs), to determine its acceptability and the feasibility of conducting a definitive trial.
DESIGN


Prospective randomised feasibility study, with blind outcome assessment at baseline, 3 and 6 months.
SETTING


Hospital based physiotherapy service.
PARTICIPANTS


Forty one adults referred for assessment and advice for any mild/moderate LTMCs. doing <120minutes of moderate intensity activity per week.
INTERVENTIONS


Participants randomised to: 1. Usual care: one usual physiotherapy advice and assessment session, including setting a physical activity goal and one follow up session (8 weeks). 2. ""Walk30×5"": session one, usual care plus intervention of walking programme. Participants were shown the website and podcasts and practiced how to use them. One follow up session (8 weeks).
OUTCOME MEASURES


Primary: timed six minute walk test (T6MWT). Secondary: step count, self-reported pain, fatigue, mood, self-efficacy, happiness, objective blood pressure, peak expiratory flow rate, and self-report and accelerometer measured physical activity.
RESULTS


Recruitment target achieved. No adverse events occurred. Adherence was high and the intervention acceptable. Loss to follow up n=3 (7%) at 3 months, n=8 (20%) at 6 months. T6MWT and step count proved suitable outcomes, unlike accelerometry. Estimated sample size for a definitive trial is 216.
CONCLUSIONS


""Walk30×5"" is ready for evaluation in a future, appropriately powered (n=216), phase III trial. If effective, the intervention will provide a cheap, highly accessible intervention to enable people with mild/moderate LTMCs to achieve UK physical activity guidelines.
CLINICAL TRIAL REGISTRATION NUMBER


ISRCTN78581097.",2020,No adverse events occurred.,"['people with long term musculoskeletal conditions (LTMCs', 'Forty one adults referred for assessment and advice for any mild/moderate LTMCs', 'people with mild to moderate musculoskeletal conditions', 'Hospital based physiotherapy service']","['delivering and evaluating a web-based walking intervention', 'usual physiotherapy advice and assessment session', 'physiotherapy walking programme']","['six minute walk test (T6MWT', 'Adherence', 'count, self-reported pain, fatigue, mood, self-efficacy, happiness, objective blood pressure, peak expiratory flow rate, and self-report and accelerometer measured physical activity']","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0587631', 'cui_str': 'Hospital-based physiotherapy service (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1542834', 'cui_str': 'Peak expiratory flow rate (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",41.0,0.110074,No adverse events occurred.,"[{'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Minns Lowe', 'Affiliation': 'Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Windmill Road, Headington, Oxford OX3 7HE, UK. Electronic address: catherine.minnslowe@ouh.nhs.uk.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kelly', 'Affiliation': 'Institute for Sport, Physical Education and Health Sciences (ISPEHS), Moray House School of Education, University of Edinburgh, EH8 8AQ, UK. Electronic address: p.kelly@ed.ac.uk.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Milton', 'Affiliation': 'The British Heart Foundation Centre on Population Approaches for Non-Communicable Disease Prevention, Nuffield Department of Population Health, UK. Electronic address: k.milton@uea.ac.uk.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Foster', 'Affiliation': 'The British Heart Foundation Centre on Population Approaches for Non-Communicable Disease Prevention, Nuffield Department of Population Health, UK. Electronic address: charlie.foster@bristol.ac.uk.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Barker', 'Affiliation': 'Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Windmill Road, Headington, Oxford OX3 7HE, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK. Electronic address: karen.barker@ouh.nhs.uk.'}]",Physiotherapy,['10.1016/j.physio.2019.08.010']
3524,32026836,Effects of land- and water-based exercise programmes on postural balance in individuals with COPD: additional results from a randomised clinical trial.,"OBJECTIVE


To investigate the effects of water-based exercise training on postural balance in individuals with chronic obstructive pulmonary disease (COPD), and compare the effects of two similar protocols of land- and water-based exercise programmes on postural balance in this population.
DESIGN


Randomised clinical trial.
SETTING


University-based, outpatient, physical therapy clinic.
SUBJECTS


Fifty individuals with COPD.
INTERVENTIONS


Participants were assigned at random to the land group (LG; n=27) or the water group (WG; n=23), and underwent high-intensity endurance and strength training three times per week for 3months.
MAIN OUTCOME MEASURES


Functional balance was assessed by the timed up and go test (TUG), and static balance was assessed with a force platform in the following conditions: standing with feet hip-width apart and eyes open; standing with feet hip-width apart and eyes closed; standing on a short base; and one-legged stance.
RESULTS


Seventeen subjects completed the intervention in the LG {nine males, mean age 64 [standard deviation (SD) 8] years, mean forced expiratory volume in 1 second (FEV 1 ) 48 (SD 17) %predicted} compared with 14 subjects in the WG [nine males, mean age 65 (SD 8) years, FEV 1  51 (SD 15) %predicted]. Water-based exercise training had a positive effect on functional balance [TUG: mean difference -1.17 (-1.93 to -0.41 95% confidence interval) seconds; P=0.006], whereas static balance remained unaltered for both groups. There was no between-group difference in postural balance after exercise training; however, a higher proportion of participants who had a clinically relevant improvement in the TUG were in the WG (LG 35%, WG 64%; P<0.001).
CONCLUSION


Functional balance improved after 3months of high-intensity exercise training performed in water. Despite the environment, non-specific training seems to be insufficient to improve static balance.
CLINICAL TRIAL REGISTRATION NUMBER


clinicalTrials.gov NCT01691131.",2020,"Water-based exercise training had a positive effect on functional balance [TUG: mean difference -1.17 (-1.93 to -0.41 95% confidence interval) seconds; P=0.006], whereas static balance remained unaltered for both groups.","['Seventeen subjects completed the intervention in the LG {nine males, mean age 64 [standard deviation (SD) 8] years', 'individuals with chronic obstructive pulmonary disease (COPD', 'University-based, outpatient, physical therapy clinic', 'Fifty individuals with COPD', 'individuals with COPD']","['Water-based exercise training', 'high-intensity endurance and strength training three times per week for 3months', 'water-based exercise training', 'land- and water-based exercise programmes']","['static balance', 'functional balance', 'postural balance', 'mean forced expiratory volume', 'timed up and go test (TUG), and static balance']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",50.0,0.102356,"Water-based exercise training had a positive effect on functional balance [TUG: mean difference -1.17 (-1.93 to -0.41 95% confidence interval) seconds; P=0.006], whereas static balance remained unaltered for both groups.","[{'ForeName': 'Larissa A', 'Initials': 'LA', 'LastName': 'de Castro', 'Affiliation': 'Research Centre in Health Sciences, University of North Parana, Londrina, Brazil; Centre of Research and Post-Graduation in Health Sciences, Londrina State University, Londrina, Brazil; Masters and Doctoral Programme in Rehabilitation Sciences, Physiotherapy Department, Londrina State University, Londrina, Brazil; University of North Parana, Londrina, Brazil; Laboratory of Research in Respiratory Physiotherapy, Physiotherapy Department, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Josiane M', 'Initials': 'JM', 'LastName': 'Felcar', 'Affiliation': 'Research Centre in Health Sciences, University of North Parana, Londrina, Brazil; Centre of Research and Post-Graduation in Health Sciences, Londrina State University, Londrina, Brazil; Masters and Doctoral Programme in Rehabilitation Sciences, Physiotherapy Department, Londrina State University, Londrina, Brazil; University of North Parana, Londrina, Brazil; Laboratory of Research in Respiratory Physiotherapy, Physiotherapy Department, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Débora R', 'Initials': 'DR', 'LastName': 'de Carvalho', 'Affiliation': 'Research Centre in Health Sciences, University of North Parana, Londrina, Brazil; Centre of Research and Post-Graduation in Health Sciences, Londrina State University, Londrina, Brazil; Masters and Doctoral Programme in Rehabilitation Sciences, Physiotherapy Department, Londrina State University, Londrina, Brazil; University of North Parana, Londrina, Brazil; Laboratory of Research in Respiratory Physiotherapy, Physiotherapy Department, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Laís S', 'Initials': 'LS', 'LastName': 'Vidotto', 'Affiliation': 'Research Centre in Health Sciences, University of North Parana, Londrina, Brazil; Masters and Doctoral Programme in Rehabilitation Sciences, Physiotherapy Department, Londrina State University, Londrina, Brazil; University of North Parana, Londrina, Brazil.'}, {'ForeName': 'Rubens A', 'Initials': 'RA', 'LastName': 'da Silva', 'Affiliation': 'Research Centre in Health Sciences, University of North Parana, Londrina, Brazil; Masters and Doctoral Programme in Rehabilitation Sciences, Physiotherapy Department, Londrina State University, Londrina, Brazil; University of North Parana, Londrina, Brazil.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Pitta', 'Affiliation': 'Masters and Doctoral Programme in Rehabilitation Sciences, Physiotherapy Department, Londrina State University, Londrina, Brazil; Laboratory of Research in Respiratory Physiotherapy, Physiotherapy Department, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Probst', 'Affiliation': 'Research Centre in Health Sciences, University of North Parana, Londrina, Brazil; Centre of Research and Post-Graduation in Health Sciences, Londrina State University, Londrina, Brazil; Masters and Doctoral Programme in Rehabilitation Sciences, Physiotherapy Department, Londrina State University, Londrina, Brazil; University of North Parana, Londrina, Brazil. Electronic address: vanessaprobst@gmail.com.'}]",Physiotherapy,['10.1016/j.physio.2019.08.001']
3525,32026838,Effectiveness of spinal manipulation and myofascial release compared with spinal manipulation alone on health-related outcomes in individuals with non-specific low back pain: randomized controlled trial.,"OBJECTIVE


To investigate the effectiveness of spinal manipulation combined with myofascial release compared with spinal manipulation alone, in individuals with chronic non-specific low back pain (CNLBP).
DESIGN


Randomized controlled trial with three months follow-up.
SETTING


Rehabilitation clinic.
PARTICIPANTS


Seventy-two individuals (between 18 and 50 years of age; CNLBP ≥12 consecutive weeks) were enrolled and randomly allocated to one of two groups: (1) Spinal manipulation and myofascial release - SMMRG; n=36) or (2) Spinal manipulation alone (SMG; n=36).
INTERVENTIONS


Combined spinal manipulation (characterized by high velocity/low amplitude thrusts) of the sacroiliac and lumbar spine and myofascial release of lumbar and sacroiliac muscles vs manipulation of the sacroiliac and lumbar spine alone, twice a week, for three weeks.
MAIN OUTCOME MEASURES


Assessments were performed at baseline, three weeks post intervention and three months follow-up. Primary outcomes were pain intensity and disability. Secondary outcomes were quality of life, pressure pain-threshold and dynamic balance.
RESULTS


No significant differences were found between SMMRG vs SMG in pain intensity and disability post intervention and at follow-up. We found an overall significant difference between-groups for CNLBP disability (SMG-SMMRG: mean difference of 5.0; 95% confidence interval of difference 9.9; -0.1), though this effect was not clinically important and was not sustained at follow-up.
CONCLUSIONS


We demonstrated that spinal manipulation combined with myofascial release was not more effective compared to spinal manipulation alone for patients with CNLBP.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03113292.",2020,No significant differences were found between SMMRG vs SMG in pain intensity and disability post intervention and at follow-up.,"['individuals with chronic non-specific low back pain (CNLBP', 'Seventy-two individuals (between 18 and 50 years of age; CNLBP ≥12 consecutive weeks', 'patients with CNLBP', 'individuals with non-specific low back pain', 'Rehabilitation clinic']","['spinal manipulation alone', 'spinal manipulation combined with myofascial release', 'Spinal manipulation and myofascial release - SMMRG; n=36) or (2) Spinal manipulation alone (SMG; n=36', 'SMMRG vs SMG', 'spinal manipulation and myofascial release', 'Combined spinal manipulation (characterized by high velocity/low amplitude thrusts) of the sacroiliac and lumbar spine and myofascial release of lumbar and sacroiliac muscles vs manipulation of the sacroiliac and lumbar spine alone']","['CNLBP disability', 'quality of life, pressure pain-threshold and dynamic balance', 'pain intensity and disability', 'health-related outcomes', 'pain intensity and disability post intervention']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic (environment)'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release (regime/therapy)'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0555898', 'cui_str': 'Sacroiliac (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",,0.152935,No significant differences were found between SMMRG vs SMG in pain intensity and disability post intervention and at follow-up.,"[{'ForeName': 'Taise Angeli', 'Initials': 'TA', 'LastName': 'Boff', 'Affiliation': 'Master in Rehabilitation Sciences, Universidade de Brasília (UnB), Campus UnB Ceilândia, Brasília, Brazil; Núcleo de Evidências e Tecnologias em Saúde (NETecS), Universidade de Brasília (UnB), Campus UnB Ceilândia, Brasília, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Pasinato', 'Affiliation': 'Núcleo de Evidências e Tecnologias em Saúde (NETecS), Universidade de Brasília (UnB), Campus UnB Ceilândia, Brasília, Brazil; School of Physical Therapy, Universidade de Brasília (UnB), Campus UnB Ceilândia, Brasília, Brazil.'}, {'ForeName': 'Ângela Jornada', 'Initials': 'ÂJ', 'LastName': 'Ben', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, The Netherlands.'}, {'ForeName': 'Maurits', 'Initials': 'M', 'LastName': 'van Tulder', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, The Netherlands; Department Physiotherapy & Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Rodrigo Luiz', 'Initials': 'RL', 'LastName': 'Carregaro', 'Affiliation': 'Master in Rehabilitation Sciences, Universidade de Brasília (UnB), Campus UnB Ceilândia, Brasília, Brazil; Núcleo de Evidências e Tecnologias em Saúde (NETecS), Universidade de Brasília (UnB), Campus UnB Ceilândia, Brasília, Brazil; School of Physical Therapy, Universidade de Brasília (UnB), Campus UnB Ceilândia, Brasília, Brazil. Electronic address: rodrigocarregaro@unb.br.'}]",Physiotherapy,['10.1016/j.physio.2019.11.002']
3526,31856052,"Stratified pain management counseling and implementation improving patient satisfaction: a prospective, pilot study.","BACKGROUND


Post-operative pain is unpleasant for patients and may worsen surgical recovery. Peri-operative multimodal analgesia has been used for many years; however, its efficacy still needs improvement. In the present study, a thorough peri-operative pain counseling and stratified management program based on risk assessment was implemented, with the goal of improving post-operative analgesia and patient satisfaction.
METHODS


This prospective, controlled, pilot study included 361 patients who underwent elective surgery. Of these 361 patients, 187 received peri-operative pain risk assessment and stratified analgesia and counseling (stratified analgesia group), while 174 received conventional multimodal analgesia (conventional group). The two groups were compared regarding the post-operative pain intensity, rescue analgesia administration, post-operative quality of recovery as assessed via the quality of recovery 40 questionnaire, total dosage of peri-operative opioids, analgesic satisfaction, and analgesic costs.
RESULTS


Compared with the conventional group, the stratified analgesia group reported decreased pain intensity during motion at 24 h post-operatively and required lower dosages of rescue analgesia (P = 0.03). The total quality of recovery 40 questionnaire score and the scores for physical wellbeing and pain were significantly better in the stratified analgesia group than the conventional group (P = 0.04); the stratified analgesia group also reported better scores for analgesic satisfaction (P = 0.03) and received lower dosages of opioids (P = 0.03). Analgesic costs were lower in the stratified analgesia group than the conventional group; the cost-effective ratio was 109 in the conventional group and 62 in the stratified analgesia group.
CONCLUSIONS


The analgesic efficacy was improved by the implementation of stratified analgesia based on surgical pain risk assessment and counseling. This stratified analgesia protocol increased the patients' analgesic satisfaction and improved the quality of recovery without increasing healthcare costs. The present findings may help improve the efficacy of peri-operative multimodal analgesia in clinical practice.
CLINICAL TRIAL REGISTRY


NCT02728973; https://clinicaltrials.gov/ct2/show/NCT02728973?term=NCT02728973&draw=2&rank=1.",2019,"Compared with the conventional group, the stratified analgesia group reported decreased pain intensity during motion at 24 h post-operatively and required lower dosages of rescue analgesia (P = 0.03).","['361 patients, 187 received peri-operative pain risk assessment and stratified analgesia and counseling (stratified analgesia group), while 174 received', '361 patients who underwent elective surgery']","['conventional multimodal analgesia (conventional group', 'Stratified pain management counseling and implementation']","['post-operative pain intensity, rescue analgesia administration, post-operative quality of recovery as assessed via the quality of recovery 40 questionnaire, total dosage of peri-operative opioids, analgesic satisfaction, and analgesic costs', 'total quality of recovery 40 questionnaire score and the scores for physical wellbeing and pain', 'analgesic satisfaction', 'cost-effective ratio', 'pain intensity', 'Analgesic costs', 'analgesic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",361.0,0.0677428,"Compared with the conventional group, the stratified analgesia group reported decreased pain intensity during motion at 24 h post-operatively and required lower dosages of rescue analgesia (P = 0.03).","[{'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': ''}, {'ForeName': 'Ju-Ying', 'Initials': 'JY', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Wen-Jian', 'Initials': 'WJ', 'LastName': 'Wang', 'Affiliation': ''}]",Chinese medical journal,['10.1097/CM9.0000000000000540']
3527,32037283,Brain activation and subjective anxiety during an anticipatory anxiety task is related to clinical outcome during prazosin treatment for alcohol use disorder.,"BACKGROUND


Higher levels of anxiety, negative affect, and impaired emotion regulation are associated with alcohol use disorder (AUD) and contribute to relapse and worse treatment outcomes. Prazosin, while typically used to treat post-traumatic stress disorder (PTSD) and other anxiety disorders, has shown promise for treating AUD. In order to better understand these underlying neural processes in individuals with AUD, our aims in this study were to measure brain activation during an anticipatory anxiety task before treatment to determine whether observed patterns supported previous work. We then aimed to measure the effects of prazosin on patients with AUD and explore whether greater baseline anticipatory anxiety (as measured by subjective and neural measures) predicts better treatment outcomes.
METHODS


Thirty-four individuals seeking treatment for AUD participated in a six-week placebo-controlled study of prazosin and underwent an anticipatory anxiety task during fMRI scans at baseline and three weeks. Alcohol use over six weeks was measured.
RESULTS


Greater levels of subjective anxiety and deactivation in posterior cingulate cortex (PCC) and ventromedial prefrontal cortex (vmPFC) were observed during high-threat stimuli compared to low-threat stimuli. Compared to placebo, prazosin reduced subjective anxiety to high-threat stimuli but there were no observed significant effects of prazosin on brain activation during the task. However, AUD patients with greater vmPFC deactivation during high threat relative to low threat and patients with low baseline anticipatory anxiety during the task had worse clinical outcomes on prazosin.
CONCLUSIONS


Deactivation in PCC and vmPFC to high-threat stimuli replicated previous work and shows promise for further study as a marker for AUD. Although prazosin did not affect brain activation in the regions of interest during the anticipatory anxiety task, subjective levels of anxiety and brain activation in vmPFC predicted treatment outcomes in individuals with AUD undergoing treatment with prazosin, highlighting individuals more likely to benefit from prazosin than others.",2020,"Compared to placebo, prazosin reduced subjective anxiety to high-threat stimuli but there were no observed significant effects of prazosin on brain activation during the task.","['individuals with AUD undergoing treatment with', 'individuals with AUD', 'Thirty-four individuals seeking treatment for AUD participated in a six-week', 'patients with AUD']","['prazosin and underwent an anticipatory anxiety task', 'placebo, prazosin', 'Prazosin', 'placebo', 'prazosin']","['baseline anticipatory anxiety', 'subjective anxiety', 'Brain activation and subjective anxiety', 'anticipatory anxiety task, subjective levels of anxiety and brain activation', 'brain activation', 'subjective anxiety and deactivation in posterior cingulate cortex (PCC) and ventromedial prefrontal cortex (vmPFC']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0032912', 'cui_str': 'Prazosin'}, {'cui': 'C0231397', 'cui_str': 'Anticipatory anxiety (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231397', 'cui_str': 'Anticipatory anxiety (finding)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}]",34.0,0.0217835,"Compared to placebo, prazosin reduced subjective anxiety to high-threat stimuli but there were no observed significant effects of prazosin on brain activation during the task.","[{'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wilcox', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA. Electronic address: cwilcox@mrn.org.'}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390, USA; VA North Texas Health Care System, 4500 S Lancaster Rd, Dallas, TX 75216, USA; Department of Psychiatry, School of Medicine, University of Colorado, 13001 E 17th Place, Aurora, CO 80045, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Clifford', 'Affiliation': 'Department of Psychiatry, University of New Mexico, 2400 Tucker NE, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, Center on Alcoholism, Substance Abuse & Addictions, University of New Mexico, 2650 Yale Blvd. SE, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Mayer', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Kylar M', 'Initials': 'KM', 'LastName': 'Boggs', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Eck', 'Affiliation': 'Mind Research Network, 1101 Yale Blvd. NE, Albuquerque, NM 87106, USA; University of Southern California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bogenschutz', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, NY 10016, USA.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102162']
3528,31938818,Effect of vitamin D on bone strength in older African Americans: a randomized controlled trial.,"There is controversy over whether African Americans have higher vitamin D requirements than recommended by the Institute of Medicine. We previously reported that maintaining serum 25(OH)D above 30 ng/mL does not prevent age-related bone loss. Herein, we report that bone strength is also unaffected by maintaining this level in this population.
INTRODUCTION


The role of vitamin D in bone strength has not been investigated in the African American (AA) population.
METHODS


A 3-year randomized controlled trial was designed to examine the effect of vitamin D supplementation on physical performance, bone loss, and bone strength in healthy older AA women. A total of 260 postmenopausal AA women, ages ≥ 60 years were randomized to a vitamin D 3  or placebo arm. Vitamin D 3  dose was adjusted to maintain serum 25OHD > 30 ng/mL. Bone mineral density, femoral axis length, and femoral neck (FN) width were measured by dual-energy X-ray absorptiometry. Composite indices of FN strength [compression strength index (CSI), bending strength index (BSI), and impact strength index (ISI)] were computed.
RESULTS


The mean age of participants was 68.2 ± 4.9 years. Baseline characteristics between groups were similar. The average dose of vitamin D 3  was 3490 ± 1465 IU/day in the active group. The mean serum 25OHD was 46.8 ± 1.2 ng/mL versus 20.7 ± 1.1 ng/mL in the active versus placebo group. Serum 25OHD did not correlate with any composite indices. The longitudinal differences observed in FN width, CSI, BSI, and ISI in both groups were not statistically significant (all p values > 0.05). Further, there was no group × time interaction effect for any of the composite indices (all p values > 0.05).
CONCLUSION


Maintaining serum 25OHD > 30 ng/mL (75 nmol/L) does not affect bone strength in older AA women. There is no evidence to support vitamin D intake greater than the recommended RDA by the Institute of Medicine in this population for bone strength.",2020,"The longitudinal differences observed in FN width, CSI, BSI, and ISI in both groups were not statistically significant (all p values > 0.05).","['African American (AA) population', '60\xa0years', 'healthy older AA women', 'The mean age of participants was 68.2\u2009±\u20094.9\xa0years', '30', 'African Americans', 'older African Americans', 'older AA women', '260 postmenopausal AA women, ages ≥']","['vitamin D supplementation', 'vitamin D', 'vitamin D 3  or placebo', 'placebo']","['bone strength', 'Bone mineral density, femoral axis length, and femoral neck ', 'FN strength [compression strength index (CSI), bending strength index (BSI), and impact strength index (ISI', 'FN width, CSI, BSI, and ISI', 'vitamin D requirements', 'physical performance, bone loss, and bone strength', 'Serum 25OHD', 'serum 25OHD', 'mean serum 25OHD']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4704755', 'cui_str': 'Flexural Properties'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C2607857'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",260.0,0.342175,"The longitudinal differences observed in FN width, CSI, BSI, and ISI in both groups were not statistically significant (all p values > 0.05).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dhaliwal', 'Affiliation': 'Metabolic Bone Disease Center, State University of New York Upstate Medical University, 750 East Adams Street, Syracuse, NY, 13210, USA. dhaliwar@upstate.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'Bone Mineral Research Center, NYU-Long Island School of Medicine, Mineola, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mikhail', 'Affiliation': 'Bone Mineral Research Center, NYU-Long Island School of Medicine, Mineola, NY, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ragolia', 'Affiliation': 'Bone Mineral Research Center, NYU-Long Island School of Medicine, Mineola, NY, USA.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Aloia', 'Affiliation': 'Bone Mineral Research Center, NYU-Long Island School of Medicine, Mineola, NY, USA.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-05275-1']
3529,31891295,An Evaluation of Ibuprofen Versus Ibuprofen/Acetaminophen for Postoperative Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis.,"The purpose of this investigation was to compare ibuprofen versus an ibuprofen/acetaminophen combination for postoperative pain control in a patient model specific to teeth diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis. One hundred and two patients presenting with moderate to severe pain from a maxillary or mandibular posterior tooth diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis were included. Following local anesthetic administration, complete endodontic cleaning and shaping was performed. Patients were randomly assigned to receive identically appearing tablets of ibuprofen 200 mg or a combination of ibuprofen 200 mg/acetaminophen 216.7 mg with instructions to take 3 tablets every 6 hours as needed for pain. Patients were also given a prescription for an escape medication to take if the study medications did not adequately control their pain. A 4-day diary was used to record pain ratings and medication use. Moderate to severe pain was experienced by 59-61% of the patients on postoperative day 1 and 50-57% of the patients on day 2, with the pain ratings decreasing over the next 2 days. There were no statistically significant differences between the 2 groups in postoperative pain, percussion pain, or medication use. There was no difference between ibuprofen and the combination of ibuprofen/acetaminophen in the reduction of postoperative pain following endodontic debridement in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis.",2019,There was no difference between ibuprofen and the combination of ibuprofen/acetaminophen in the reduction of postoperative pain following endodontic debridement in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis.,"['One hundred and two patients presenting with moderate to severe pain from a maxillary or mandibular posterior tooth diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis', 'Patients', 'patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis', 'postoperative pain control in a patient model specific to teeth diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis']","['ibuprofen/acetaminophen', 'ibuprofen', 'Ibuprofen Versus Ibuprofen/Acetaminophen', 'ibuprofen/acetaminophen combination', 'ibuprofen 200 mg or a combination of ibuprofen 200 mg/acetaminophen']","['postoperative pain', 'Moderate to severe pain', 'postoperative pain, percussion pain, or medication use', 'pain ratings', 'Postoperative Endodontic Pain']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C4039735', 'cui_str': 'Symptomatic irreversible pulpitis (disorder)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0031030', 'cui_str': 'Periodontitis, Apical'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C2741117', 'cui_str': 'Ibuprofen 200 MG [Ultraprin]'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}]",102.0,0.145842,There was no difference between ibuprofen and the combination of ibuprofen/acetaminophen in the reduction of postoperative pain following endodontic debridement in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis.,"[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Stamos', 'Affiliation': 'Former Graduate Student in Endodontics, The Ohio State University.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Drum', 'Affiliation': 'Professor and Graduate Program Director, Division of Endodontics, The Ohio State University.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Reader', 'Affiliation': 'Emeritus Professor, Division of Endodontics, The Ohio State University.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nusstein', 'Affiliation': 'Professor and Chair, Division of Endodontics, The Ohio State University.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Fowler', 'Affiliation': 'Assistant Professor and Predoctoral Director, Division of Endodontics, The Ohio State University.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Beck', 'Affiliation': 'Emeritus Associate Professor, Division of Biosciences, The Ohio State University.'}]",Anesthesia progress,['10.2344/anpr-66-03-06']
3530,31764336,"The ""Cough Trick"" Reduces Pain During Removal of Closed-suction Drains after Total Knee Arthroplasty: A Randomized Trial.","BACKGROUND


Drain removal after TKA can be painful. Prior research suggests that the ""cough trick,"" in which a patient coughs at the same time she or he receives an injection, effectively decreases pain. To our knowledge, this intervention has not been evaluated as a way to reduce pain during other brief but painful interventions, such as removal of closed-suction drains after orthopaedic surgery.
QUESTION/PURPOSE


Does the cough trick reduce pain while a surgeon is removing a closed-suction drain after TKA?
METHODS


Fifty-six patients with primary osteoarthritis who underwent primary TKA were randomized into two groups: drain removal as the patient coughed (n = 28 patients; three men, 25 women) or drain removal using the usual process, without the cough trick (n = 28 patients; three men, 25 women). The study groups were not different in terms of gender, BMI, surgical time, or other baseline variables, and other than the addition of the cough trick, there were no differences in surgical treatment or other elements of aftercare. Likewise, at baseline, the verbal numeric rating scale (VNRS) score for pain before the drain was removed was not different between the groups (3.1 ± 1.7 versus 3.3 ± 1.3; p = 0.72). The level of pain before and during drain removal was recorded using a VNRS by an orthopaedic surgeon who was not involved in the care of the study patients. We considered the minimum clinically important difference on the 10-point scale to be 2 points, based on prior evidence.
RESULTS


The mean ± SD VNRS for the pain level during drain removal was lower in the cough trick group than that in the control group (1.6 ± 1.0 versus 3.7 ± 1.9, mean difference 2.1; 95% CI, 1.3-2.9; p < 0.001).
CONCLUSIONS


The cough trick during removal of a closed-suction drain tube in patients undergoing TKA reduced the level of pain in this small randomized trial. We suggest that surgeons consider this technique when removing drains after TKA because it is a noninvasive technique and it is easy to perform. Because the cough trick has been shown by others to be effective at reducing pain during venipuncture and parenteral injections, and we found it was effective for that purpose during drain removal after TKA, we believe this finding probably generalizes well to most minor procedures that cause transient, sharp pain. We suggest that it could be used to make such procedures more comfortable for patients, as well as for drain removal in other types of surgery where drains still are commonly used (including spine surgery and tumor surgery).
LEVEL OF EVIDENCE


Level I, therapeutic study.",2019,"The mean ± SD VNRS for the pain level during drain removal was lower in the cough trick group than that in the control group (1.6 ± 1.0 versus 3.7 ± 1.9, mean difference 2.1; 95% CI, 1.3-2.9; p < 0.001).
","['n = 28 patients; three men, 25 women', 'after Total Knee Arthroplasty', 'n = 28 patients; three men, 25 women) or', 'Fifty-six patients with primary osteoarthritis who underwent primary TKA']","['drain removal as the patient coughed', 'Cough Trick"" Reduces Pain During Removal of Closed-suction Drains', 'drain removal using the usual process, without the cough trick']","['verbal numeric rating scale (VNRS) score for pain before the drain', 'level of pain', 'mean ± SD VNRS for the pain level during drain removal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1384584', 'cui_str': 'Generalized osteoarthritis (disorder)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0441139', 'cui_str': 'Suction drain (physical object)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}]",25.0,0.143798,"The mean ± SD VNRS for the pain level during drain removal was lower in the cough trick group than that in the control group (1.6 ± 1.0 versus 3.7 ± 1.9, mean difference 2.1; 95% CI, 1.3-2.9; p < 0.001).
","[{'ForeName': 'Varah', 'Initials': 'V', 'LastName': 'Yuenyongviwat', 'Affiliation': 'V. Yuenyongviwat, K. Iamthanaporn, P. Tuntarattanapong, T. Hongnaparak, Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Songkhla Thailand.'}, {'ForeName': 'Khanin', 'Initials': 'K', 'LastName': 'Iamthanaporn', 'Affiliation': ''}, {'ForeName': 'Pakjai', 'Initials': 'P', 'LastName': 'Tuntarattanapong', 'Affiliation': ''}, {'ForeName': 'Theerawit', 'Initials': 'T', 'LastName': 'Hongnaparak', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000901']
3531,32017643,Vaccine hesitancy and influenza beliefs among parents of children requiring a second dose of influenza vaccine in a season: An American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) study.,"To receive adequate protection against influenza, some children 6 months through 8 y old need two doses of influenza vaccine in a given season. Currently, only half of those receiving the first dose receive a second. Our objective was to assess vaccine hesitancy and influenza disease and vaccine knowledge, attitudes, and beliefs among caregivers of children who received the first of their two needed doses. As part of a national-randomized control trial of second dose text-message influenza vaccine reminders (2017-2018 season), a telephone survey collected caregiver and index child demographic information. Each child had received the first of two needed influenza vaccine doses. Caregivers completed a measure of general vaccine hesitancy - the five-question Parent Attitudes About Childhood Vaccines Survey Tool (PACV-5) - and questions about influenza infection and vaccine. We assessed associations between participant demographic characteristics, vaccine hesitancy, and influenza beliefs and calculated the standardized proportion of caregivers endorsing each outcome using logistic regression. Analyses included responses from 256 participants from 36 primary care practices in 24 states. Some caregivers (11.7%) reported moderate/high vaccine hesitancy and many had misperceptions about influenza disease and vaccine. In multivariable models, no single variable was consistently associated with inaccurate knowledge, attitudes, and beliefs. These results demonstrate that caregivers whose children received the first dose of influenza vaccine may still be vaccine hesitant and have inaccurate influenza beliefs. Pediatricians should consider broadly addressing inaccurate beliefs and promoting vaccination even after caregivers agree to the first dose.",2020,Caregivers completed a measure of general vaccine hesitancy - the five-question Parent Attitudes,"['caregivers of children who received the first of their two needed doses', 'parents of children requiring a second dose of', '256 participants from 36 primary care practices in 24 states']","['text-message influenza vaccine reminders', 'general vaccine hesitancy - the five-question Parent Attitudes', 'influenza vaccine']","['inaccurate knowledge, attitudes, and beliefs', 'participant demographic characteristics, vaccine hesitancy, and influenza beliefs']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine (finding)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0443236', 'cui_str': 'Inaccurate (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine (finding)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}]",,0.0425927,Caregivers completed a measure of general vaccine hesitancy - the five-question Parent Attitudes,"[{'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Nekrasova', 'Affiliation': ""Department of Pediatrics, Center for Pediatric Clinical Effectiveness & PolicyLab, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Melissa S', 'Initials': 'MS', 'LastName': 'Stockwell', 'Affiliation': 'Department of Pediatrics, Department of Population and Family Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Localio', 'Affiliation': 'Department of Biostatistics, Epidemiology & Informatics, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Shults', 'Affiliation': 'Department of Biostatistics, Epidemiology & Informatics, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Wynn', 'Affiliation': 'Department of Pediatrics, Columbia University, New York, NY, USA.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Shone', 'Affiliation': 'Department of Research, American Academy of Pediatrics, Itasca, IL, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Berrigan', 'Affiliation': ""Department of Pediatrics, Center for Pediatric Clinical Effectiveness & PolicyLab, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Kolff', 'Affiliation': 'Department of Pediatrics, Department of Population and Family Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Griffith', 'Affiliation': 'Department of Research, American Academy of Pediatrics, Itasca, IL, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': ""Department of Pediatrics, Center for Pediatric Clinical Effectiveness & PolicyLab, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Torres', 'Affiliation': 'Department of Research, American Academy of Pediatrics, Itasca, IL, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Opel', 'Affiliation': ""University of Washington School of Medicine and Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Fiks', 'Affiliation': ""Department of Pediatrics, Center for Pediatric Clinical Effectiveness & PolicyLab, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1707006']
3532,21282282,Differential efficacy of three cycles of CMF followed by tamoxifen in patients with ER-positive and ER-negative tumors: long-term follow up on IBCSG Trial IX.,"BACKGROUND


The benefit of adjuvant chemotherapy in postmenopausal patients with estrogen receptor (ER)-positive lymph node-negative breast cancer is being reassessed.
PATIENTS AND METHODS


After stratification by ER status, 1669 postmenopausal patients with operable lymph node-negative breast cancer were randomly assigned to three 28-day courses of 'classical' CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy followed by tamoxifen for 57 months (CMF→tamoxifen) or to tamoxifen alone for 5 years.
RESULTS


ERs were positive in 81% of tumors. At a median follow-up of 13.1 years, patients with ER-positive breast cancers did not benefit from CMF [13-year disease-free survival (DFS) 64% CMF→tamoxifen, 66% tamoxifen; P = 0.99], whereas CMF substantially improved the prognosis of patients with ER-negative breast cancer (13-year DFS 73% versus 57%, P = 0.001). Similarly, breast cancer-free interval (BCFI) was identical in the ER-positive cohort but significantly improved by chemotherapy in the ER-negative cohort (13-year BCFI 80% versus 63%, P = 0.001). CMF had no influence on second nonbreast malignancies or deaths from other causes.
CONCLUSION


CMF is not beneficial in postmenopausal patients with node-negative ER-positive breast cancer but is highly effective within the ER-negative cohort. In the future, other markers of chemotherapy response may define a subset of patients with ER-positive tumors who may benefit from adjuvant chemotherapy.",2011,"(13-year DFS 73% versus 57%, P = 0.001).","['patients with ER-negative breast cancer', 'postmenopausal patients with node-negative ER-positive breast cancer', 'patients with ER-positive tumors who may benefit from adjuvant chemotherapy', '1669 postmenopausal patients with operable lymph node-negative breast cancer', 'patients with ER-positive and ER-negative tumors', 'postmenopausal patients with estrogen receptor (ER)-positive lymph node-negative breast cancer']","['CMF', 'adjuvant chemotherapy', ""classical' CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy followed by tamoxifen for 57 months (CMF→tamoxifen) or to tamoxifen alone"", 'tamoxifen']","['breast cancer-free interval (BCFI', 'CMF [13-year disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}]","[{'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",1669.0,0.107085,"(13-year DFS 73% versus 57%, P = 0.001).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Aebi', 'Affiliation': 'Division of Medical Oncology, Berne University Hospital and Swiss Group for Clinical Cancer research, Berne, Switzerland. stefan.aebi@onkologie.ch'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Braun', 'Affiliation': ''}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Castiglione-Gertsch', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rabaglio', 'Affiliation': ''}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Crivellari', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lindtner', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Snyder', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simoncini', 'Affiliation': ''}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Gusterson', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': ''}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq754']
3533,32022664,"Safety of lemborexant versus placebo and zolpidem: effects on auditory awakening threshold, postural stability, and cognitive performance in healthy older participants in the middle of the night and upon morning awakening.","STUDY OBJECTIVES


Our aim was to evaluate the effect of lemborexant versus zolpidem tartrate extended release 6.25 mg (ZOL) or placebo (PBO) on postural stability, auditory awakening threshold (AAT), and cognitive performance (cognitive performance assessment battery [CPAB]).
METHODS


Healthy women (≥ 55 years) and men (≥ 65 years) were randomized, double-blind, to 1 of 4-period, single-dose crossover sequences, starting with lemborexant 5 mg (LEM5), 10 mg (LEM10), ZOL, or PBO. A ≥ 14-day washout followed all 4 treatments. Assessments were middle-of-the-night (MOTN) change from baseline in postural stability (primary prespecified comparison: LEM vs ZOL), AAT, absolute AAT, and CPAB for LEM5 and LEM10 versus ZOL and PBO; and morning change from baseline in postural stability and CPAB for LEM5 and LEM10 versus ZOL and PBO. Change from baseline measures were time-matched to a baseline night/morning when no study drug was administered.
RESULTS


MOTN: Mean MOTN change from baseline in body sway was significantly higher for ZOL versus both lemborexant doses. There were no differences among the treatments regarding decibels required to awaken a participant. LEM5 was not statistically different from PBO on any CPAB domain; LEM10 and ZOL showed poorer performance on some tests of attention and/or memory. Morning: Body sway and cognitive performance following LEM5 or LEM10 did not differ from PBO; body sway was significantly higher for ZOL than PBO. Rates of treatment-emergent adverse events were low; there were no serious adverse events.
CONCLUSIONS


Lemborexant causes less postural instability than a commonly used sedative-hypnotic and does not impair the ability to awaken to auditory signals.
CLINICAL TRIALS REGISTRATION


Registry: ClinicalTrials.gov; Name: Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older; URL: https://clinicaltrials.gov/ct2/show/NCT03008447; Identifier: NCT03008447.",2020,Morning: Body sway and cognitive performance following LEM5 or LEM10 did not differ from PBO; body sway was significantly higher for ZOL than PBO.,"['MOTN', 'Healthy Older Subjects in the Middle of the Night and Upon Morning Awakening', 'Healthy females (≥55 years) and males (≥65 years']","['ZOL', 'Lemborexant Versus Placebo and Zolpidem', 'LEM5 or LEM10', 'lemborexant 5 mg (LEM5), 10 mg (LEM10), ZOL, or PBO', 'lemborexant versus zolpidem tartrate extended release 6.25 mg (ZOL) or placebo (PBO']","['Auditory Awakening Threshold, Postural Stability, and Cognitive Performance', 'postural stability, auditory awakening threshold (AAT), and cognitive performance (cognitive performance assessment battery [CPAB', 'postural stability and CPAB for LEM5 and LEM10 versus ZOL and PBO', 'postural instability', 'AAT, absolute AAT, and CPAB for LEM5 and LEM10 versus ZOL and PBO', 'Morning: Body sway and cognitive performance', 'middle-of-the-night (MOTN) change from baseline in postural stability']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0724725', 'cui_str': 'Zolpidem tartrate'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4517821', 'cui_str': '6.25'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.114546,Morning: Body sway and cognitive performance following LEM5 or LEM10 did not differ from PBO; body sway was significantly higher for ZOL than PBO.,"[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Murphy', 'Affiliation': 'Formerly of Eisai Inc., Woodcliff Lake, New Jersey.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Eisai Inc., Woodcliff Lake, New Jersey.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs Drug Development Corporation, New York, New York.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Rosenberg', 'Affiliation': 'NeuroTrials Research Inc., Atlanta, Georgia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc., Woodcliff Lake, New Jersey.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8294']
3534,21325445,Long-term results of International Breast Cancer Study Group Trial VIII: adjuvant chemotherapy plus goserelin compared with either therapy alone for premenopausal patients with node-negative breast cancer.,"BACKGROUND


The International Breast Cancer Study Group Trial VIII compared long-term efficacy of endocrine therapy (goserelin), chemotherapy [cyclophosphamide, methotrexate and fluorouracil (CMF)], and chemoendocrine therapy (CMF followed by goserelin) for pre/perimenopausal women with lymph-node-negative breast cancer.
PATIENTS AND METHODS


From 1990 to 1999, 1063 patients were randomized to receive (i) goserelin for 24 months (n = 346), (ii) six courses of 'classical' CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy (n = 360), or (iii) six courses of CMF plus 18 months goserelin (CMF→ goserelin; n = 357). Tumors were classified as estrogen receptor (ER) negative (19%), ER positive (80%), or ER unknown (1%); 19% of patients were younger than 40. Median follow-up was 12.1 years.
RESULTS


For the ER-positive cohort, sequential therapy provided a statistically significant benefit in disease-free survival (DFS) (12-year DFS = 77%) compared with CMF alone (69%) and goserelin alone (68%) (P = 0.04 for each comparison), due largely to the effect in younger patients. Patients with ER-negative tumors whose treatment included CMF had similar DFS (12-year DFS CMF = 67%; 12-year DFS CMF→ goserelin = 69%) compared with goserelin alone (12-year DFS = 61%, P= NS).
CONCLUSIONS


For pre/perimenopausal women with lymph-node-negative ER-positive breast cancer, CMF followed by goserelin improved DFS in comparison with either modality alone. The improvement was the most pronounced in those aged below 40, suggesting an endocrine effect of prolonged CMF-induced amenorrhea.",2011,"For the ER-positive cohort, sequential therapy provided a statistically significant benefit in disease-free survival (DFS) (12-year DFS = 77%) compared with CMF alone (69%) and goserelin alone (68%)","['From 1990 to 1999, 1063 patients', 'perimenopausal women with lymph-node-negative ER-positive breast cancer', 'premenopausal patients with node-negative breast cancer', 'Patients with ER-negative tumors', 'pre/perimenopausal women with lymph-node-negative breast cancer']","['CMF', ""classical' CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy (n = 360), or (iii) six courses of CMF plus 18 months goserelin (CMF→ goserelin"", 'chemoendocrine therapy (CMF followed by goserelin', 'endocrine therapy (goserelin), chemotherapy [cyclophosphamide, methotrexate and fluorouracil (CMF', 'goserelin', 'chemotherapy plus goserelin']","['endocrine effect of prolonged CMF-induced amenorrhea', 'disease-free survival (DFS', 'estrogen receptor (ER) negative']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",1063.0,0.0567957,"For the ER-positive cohort, sequential therapy provided a statistically significant benefit in disease-free survival (DFS) (12-year DFS = 77%) compared with CMF alone (69%) and goserelin alone (68%)","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden. per.karlsson@oncology.gu.se'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Braun', 'Affiliation': ''}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Castiglione-Gertsch', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rabaglio', 'Affiliation': ''}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Crivellari', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Murray', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': ''}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Gusterson', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': ''}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq735']
3535,31986239,"Evaluating body composition in infancy and childhood: A comparison between 4C, QMR, DXA, and ADP.","BACKGROUND


Accurate and precise methods to measure of body composition in infancy and childhood are needed.
OBJECTIVES


This study evaluated differences and precision of three methods when compared with the four-compartment (4C) model for estimating fat mass (FM).
METHODS


FM of children (age 14 days to 6 years of age, N = 346) was obtained using quantitative nuclear magnetic resonance (QMR, EchoMRI-AH), air-displacement plethysmography (ADP, PeaPod, less than or equal to 8 kg, BodPod age 6 years or older), and dual-energy X-ray absorptiometry (DXA, Hologic QDR). The 4C model was computed. Correlation, concordance, and Bland-Altman analyses were performed.
RESULTS


In infants, PeaPod had high individual FM accuracy, whereas DXA had high group FM accuracy compared with 4C. In children, DXA had high group and individual FM accuracies compared with 4C. QMR underestimated group FM in infants and children (300 and 510 g, respectively). The instrument FM precision was best for QMR (10 g) followed by BodPod (34 g), PeaPod (38 g), and DXA (45 g).
CONCLUSIONS


In infants, PeaPod was the best method to estimate individual FM whereas DXA was best to estimate group FM. In children, DXA was best to estimate individual and group FM. QMR had the highest instrument precision.",2020,"In children, DXA had high group and individual FM accuracies compared with 4C. QMR underestimated group FM in infants and children (300 and 510 g, respectively).","['infancy and childhood', 'FM of children (age 14\u2009days to 6\u2009years of age, N = 346']","['quantitative nuclear magnetic resonance (QMR, EchoMRI-AH), air-displacement plethysmography (ADP, PeaPod, less than or equal to 8 kg, BodPod age 6\u2009years or older), and dual-energy X-ray absorptiometry (DXA, Hologic QDR']","['individual FM accuracy', 'individual FM accuracies', 'FM accuracy']","[{'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",,0.0298047,"In children, DXA had high group and individual FM accuracies compared with 4C. QMR underestimated group FM in infants and children (300 and 510 g, respectively).","[{'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'Heard-Lipsmeyer', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Hull', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Clark R', 'Initials': 'CR', 'LastName': 'Sims', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Cleves', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Andres', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}]",Pediatric obesity,['10.1111/ijpo.12617']
3536,30862526,Periodized and non-periodized resistance training programs on body composition and physical function of older women.,"BACKGROUND AND PURPOSE


Although combining classical resistance (RT) and power training (PT) might be an efficient strategy to achieve optimal enhancements in body composition and physical function in older adults, the most effective approach to combine these different types of exercise training is still unknown. Periodization, an organizational model that refers to a succession of cycle that will vary in exercise intensity and/or volume to allow for the training stimulus to remain biologically challenging and effective, may represent an interesting approach. Among the different types of periodization, daily undulating periodization (DUP) has attracted considerable attention given its superiority in comparison to nonperiodized (NP) RT programs to elicit neuromuscular improvements in young adults. However, whether a DUP program combining PT and traditional RT can produce similar or greater improvements in body composition and physical function in older adults than a NP RT program has not yet been established. Therefore, the present study compared the effects of a DUP and NP programs on body composition and physical function in healthy community-dwelling older women.
METHODS


Forty-two older women (60-79 years) were randomized into one of the three experimental groups: NP, DUP, and control group (CG). Body composition and physical function were assessed at baseline and after the intervention. The sessions of exercises were performed twice a week over 22 weeks. In NP, the two exercise sessions were based on three sets of 8-10 repetitions at a ""difficult"" intensity (i.e., 5-6) prescribed based on the Rating of Perceived Exertion (RPE) scale. In DUP, the first session was based on PT (three sets of 8-10 repetitions at a ""moderate"" intensity, i.e., 3, performed as fast as possible), while the second session was similar to the NP.
RESULTS


There were no significant changes in body composition in any of the groups. Relative to baseline, participants assigned to NP showed significant improvements in countermovement jump (+55.7%), timed ""Up and Go"" (TUG) test (-43.2%, faster), walking speed (+12.0%), and one-leg-stand (+154.5%). In contrast, DUP only improved TUG performance (-53.2%, faster).
CONCLUSION


NP and DUP improved physical function in community-dwelling older women, with greater improvements in physical parameters only observed after NP.",2019,"Relative to baseline, participants assigned to NP showed significant improvements in countermovement jump (+55.7%), timed ""Up and Go"" (TUG) test (-43.2%, faster), walking speed (+12.0%), and one-leg-stand (+154.5%).","['young adults', 'community-dwelling older women', 'older adults', 'healthy community-dwelling older women', 'older women', 'Forty-two older women (60-79\u202fyears']","['NP, DUP, and control group (CG', 'Periodized and non-periodized resistance training programs', 'DUP and NP programs', 'NP and DUP', 'nonperiodized (NP) RT programs', 'classical resistance (RT) and power training (PT', 'periodization, daily undulating periodization (DUP']","['physical function', 'walking speed', 'Rating of Perceived Exertion (RPE) scale', 'timed ""Up and Go"" (TUG) test', 'body composition', 'Body composition and physical function', 'countermovement jump', 'physical parameters', 'TUG performance', 'body composition and physical function']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}]",42.0,0.0158944,"Relative to baseline, participants assigned to NP showed significant improvements in countermovement jump (+55.7%), timed ""Up and Go"" (TUG) test (-43.2%, faster), walking speed (+12.0%), and one-leg-stand (+154.5%).","[{'ForeName': 'Hélio José', 'Initials': 'HJ', 'LastName': 'Coelho-Júnior', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Av. Érico Veríssimo, 701, Cidade Universitária ""Zeferino Vaz"", Barão Geraldo, CEP: 13.083-851 Campinas, SP, Brazil; Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: helio.j.coelho.junior@gmail.com.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'de Oliveira Gonçalvez', 'Affiliation': 'Center of Health Sciences, University of Mogi das Cruzes, Mogi das Cruzes, Brazil.'}, {'ForeName': 'Ricardo Aurélio Carvalho', 'Initials': 'RAC', 'LastName': 'Sampaio', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Av. Érico Veríssimo, 701, Cidade Universitária ""Zeferino Vaz"", Barão Geraldo, CEP: 13.083-851 Campinas, SP, Brazil.'}, {'ForeName': 'Priscila Yukari', 'Initials': 'PY', 'LastName': 'Sewo Sampaio', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Av. Érico Veríssimo, 701, Cidade Universitária ""Zeferino Vaz"", Barão Geraldo, CEP: 13.083-851 Campinas, SP, Brazil.'}, {'ForeName': 'Eduardo Lusa', 'Initials': 'EL', 'LastName': 'Cadore', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Department of Health Sciences, Public University of Navarre, CIBERFES (CB16/10/00315), Pamplona, Navarre, Spain.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Marzetti', 'Affiliation': 'Università Cattolica del Sacro Cuore, Rome, Italy; Fondazione Policlinico Universitario ""Agostino Gemelli"" IRCCS, Rome, Italy.'}, {'ForeName': 'Marco Carlos', 'Initials': 'MC', 'LastName': 'Uchida', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Av. Érico Veríssimo, 701, Cidade Universitária ""Zeferino Vaz"", Barão Geraldo, CEP: 13.083-851 Campinas, SP, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2019.03.001']
3537,31818053,The application of musculoskeletal ultrasonography in sports injuries of lower limbs in Chongqing Marathon competition.,"BACKGROUND


High incidence of sports injury occurring during marathon competitions urges a pressing demand for a convenient and accurate diagnostic tool of such injuries. However, contemporary information on the application of musculoskeletal ultrasonography (MSUS) in sports injury is not sufficient.
METHODS


A repeated measures study was used to describe the distribution of lower limb injuries in the Chongqing marathon and the application of MSUS in assessing these sports injuries. To verify the diagnostic accuracy of MSUS for sports injury, participants were assigned to group A (MSUS group) or group B (Sports medicine physician, i.e. SMP group), each group had an independent procedure of making a diagnosis. That is, ultrasound physicians in group A made a diagnosis from the ultrasonographic images while sports medicine physicians in group B synthesizing symptoms and signs of patients to identify the exact injury.
RESULTS


No statistically significant difference was found in the participants of the baseline characteristics between the two groups (P>0.05). In both groups, the knee was accounted as the vast majority of running injury sites, followed by the ankle (P=0.152). Tendons and ligaments injuries (χ2=48.437 and P=0.000) were the most common types of injury. Visual Analog Scale (VAS), a higher score of which indicates severer pain (0 to 10), was used to evaluate the severity of pain from injuries. VAS scores decreased significantly (P<0.05) in both groups after immediate treatment and the decrease in group A was significantly greater than group B (P=0.007). For athletes with pain sustained or exacerbated, further MRI exam showed a concordance rate of approximately 100% between MSUS and MRI diagnosis.
CONCLUSIONS


Musculoskeletal ultrasonography could be applied as an efficient method for the diagnosis of sports injuries in the athletic competition field.",2020,VAS scores decreased significantly (P<0.05) in both groups after immediate treatment and the decrease in group A was significantly greater than group B (P=0.007).,['sports injuries of lower limbs in Chongqing Marathon competition'],['musculoskeletal ultrasonography (MSUS'],"['Tendons and ligaments injuries', 'VAS scores', 'concordance rate', 'Visual Analog Scale (VAS']","[{'cui': 'C0004161', 'cui_str': 'Sports Injuries'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0041618', 'cui_str': 'Echotomography'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0435001', 'cui_str': 'Ligament injury (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",,0.0220795,VAS scores decreased significantly (P<0.05) in both groups after immediate treatment and the decrease in group A was significantly greater than group B (P=0.007).,"[{'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation Medicine, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Gongwei', 'Initials': 'G', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Zonghui', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Sport Rehabilitation Research Institute, Southwest University, Chongqing, China.'}, {'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China - 303518@cqmu.edu.cn.'}, {'ForeName': 'Lehua', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.19.09925-0']
3538,31565909,Physical performance is not improved with vitamin D repletion: a randomized trial.,"BACKGROUND


Studies enrolling physically active participants have used various vitamin D dosing strategies which can result in diverse post supplementation vitamin D status due to individual body weight and initial vitamin D status. Emerging evidence suggests serum 25(OH)D levels of 100-120 nmol/L are optimal for peak performance, however, studies generally administer the same dose for all participants regardless of initial 25(OH)D status and body weight. This approach will not likely get all participants to the optimal 25(OH)D level proposed for optimal physical performance. Therefore, it's important to enroll vitamin D insufficient/deficient participants to observe the effects of vitamin D supplementation on physical performance. We assessed vitamin D repletion on markers of anaerobic performance in physically active adults by replenishing insufficient/deficient vitamin D to the target of 100-120 nmol/L suggested for optimal physical performance.
METHODS


We conducted a double-blind randomized control trial in 42 physically active participants, 18-42 years of age in the winter months. Physically active participants with insufficient/deficient 25(OH)D status (<75 nmol/L) were supplemented with an individualized dosing strategy to achieve 25(OH)D of 120 nmol/L with eight weeks of supplementation using the following formula: Dose (IU)=40•[Target 25(OH)D3 - Initial 25(OH)D3]•Body Weight (kg). A modified Wingate test, 10m and 40m sprints, vertical jump, hand grip strength, pushups, and isokinetic knee flexion and extension were assessed before and after repletion of 25(OH)D.
RESULTS


Thirty-nine out of 42 participants completed the study. Twenty-seven participants in the vitamin D group significantly increased 25(OH)D from 61 nmol/L to 123 nmol/L (P<0.001). 12 participants in the Placebo group had a significant decrease in 25(OH)D from 98 nmol/L to 83 nmol/L (P=0.02). Despite these changes in 25(OH)D status in each group, no significant changes in anaerobic performance markers were found.
CONCLUSIONS


These findings indicate that vitamin D repletion to levels sufficient for optimal physical performance does not improve anaerobic physical performance.",2020,"Despite these changes in 25(OH)D status in each group, no significant changes in anaerobic performance markers were found.
","['physically active adults', 'Physically active participants with insufficient/deficient 25(OH)D status (< 75 nmol/L', '27 participants in the', '42 physically active participants, 18-42 years of age in the winter months']","['Placebo', 'vitamin D supplementation', 'vitamin D', 'vitamin D repletion']","['anaerobic performance markers', 'anaerobic physical performance', 'physical performance', 'Physical performance']","[{'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]",[{'cui': 'C2607857'}],27.0,0.128759,"Despite these changes in 25(OH)D status in each group, no significant changes in anaerobic performance markers were found.
","[{'ForeName': 'Shane D', 'Initials': 'SD', 'LastName': 'Scholten', 'Affiliation': 'Exercise and Sport Sciences, Augustana University, Sioux Falls, SD, USA - shane.scholten@augie.edu.'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Ferley', 'Affiliation': 'Avera Sports Institute, Avera McKennan Hospital and University Health Center, Sioux Falls, SD, USA.'}, {'ForeName': 'Chad B', 'Initials': 'CB', 'LastName': 'Birger', 'Affiliation': 'Human Resources, MetaBank, Sioux Falls, SD, USA.'}, {'ForeName': 'Cortney', 'Initials': 'C', 'LastName': 'Dowling', 'Affiliation': 'Department of Chemistry, Liberty University, Lynchburg, VA, USA.'}, {'ForeName': 'Mikenzie', 'Initials': 'M', 'LastName': 'Mikkelson', 'Affiliation': 'Department of Natural Sciences, Black Hills State University, Spearfish, SD, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Springer', 'Affiliation': 'Department of Natural Sciences, University of Sioux Falls, Sioux Falls, SD, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Lucs', 'Affiliation': 'Department of Physical Therapy, Des Moines University, Des Moines, IA, USA.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.19.09607-5']
3539,31000010,Complete Revascularization Versus Culprit Lesion Only in Patients With ST-Segment Elevation Myocardial Infarction and Multivessel Disease: A DANAMI-3-PRIMULTI Cardiac Magnetic Resonance Substudy.,"OBJECTIVES


The aim of this study was to evaluate the effect of fractional flow reserve (FFR)-guided revascularization compared with culprit-only percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) on infarct size, left ventricular (LV), function, LV remodeling, and the presence of nonculprit infarctions.
BACKGROUND


Patients with STEMI with multivessel disease might have improved clinical outcomes after complete revascularization compared with PCI of the infarct-related artery only, but the impact on infarct size, LV function, and remodeling as well as the risk for periprocedural infarction are unknown.
METHODS


In this substudy of the DANAMI-3 (Third Danish Trial in Acute Myocardial Infarction)-PRIMULTI (Primary PCI in Patients With ST-Elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization) randomized trial, patients with STEMI with multivessel disease were randomized to receive either complete FFR-guided revascularization or PCI of the culprit vessel only. The patients underwent cardiac magnetic resonance imaging during index admission and at 3-month follow-up.
RESULTS


A total of 280 patients (136 patients with infarct-related and 144 with complete FFR-guided revascularization) were included. There were no differences in final infarct size (median 12% [interquartile range: 5% to 19%] vs. 11% [interquartile range: 4% to 18%]; p = 0.62), myocardial salvage index (median 0.71 [interquartile range: 0.54 to 0.89] vs. 0.66 [interquartile range: 0.55 to 0.87]; p = 0.49), LV ejection fraction (mean 58 ± 9% vs. 59 ± 9%; p = 0.39), and LV end-systolic volume remodeling (mean 7 ± 22 ml vs. 7 ± 19 ml; p = 0.63). New nonculprit infarction occurring after the nonculprit intervention was numerically more frequent among patients treated with complete revascularization (6 [4.5%] vs. 1 [0.8%]; p = 0.12).
CONCLUSIONS


Complete FFR-guided revascularization in patients with STEMI and multivessel disease did not affect final infarct size, LV function, or remodeling compared with culprit-only PCI.",2019,"There were no differences in final infarct size (median 12% [interquartile range: 5% to 19%] vs. 11% [interquartile range: 4% to 18%]; p = 0.62), myocardial salvage index (median 0.71 [interquartile range: 0.54 to 0.89] vs. 0.66 [interquartile range: 0.55 to 0.87]; p = 0.49), LV ejection fraction (mean 58 ± 9% vs. 59 ± 9%; p = 0.39), and LV end-systolic volume remodeling (mean 7 ± 22 ml vs. 7 ± 19 ml; p = 0.63).","['patients with STEMI with multivessel disease', 'patients with ST-segment elevation myocardial\xa0infarction (STEMI', 'Patients With ST-Elevation Myocardial Infarction and Multivessel Disease', '280 patients (136 patients with infarct-related and 144 with complete FFR-guided revascularization', 'Patients With ST-Segment Elevation Myocardial Infarction and Multivessel Disease', 'Patients with STEMI with multivessel disease']","['complete FFR-guided revascularization or PCI of the culprit vessel only', 'fractional flow reserve (FFR)-guided revascularization compared with culprit-only percutaneous coronary intervention (PCI', 'cardiac magnetic resonance imaging']","['final infarct size', 'LV end-systolic volume remodeling', 'LV ejection fraction', 'myocardial salvage index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",280.0,0.118493,"There were no differences in final infarct size (median 12% [interquartile range: 5% to 19%] vs. 11% [interquartile range: 4% to 18%]; p = 0.62), myocardial salvage index (median 0.71 [interquartile range: 0.54 to 0.89] vs. 0.66 [interquartile range: 0.55 to 0.87]; p = 0.49), LV ejection fraction (mean 58 ± 9% vs. 59 ± 9%; p = 0.39), and LV end-systolic volume remodeling (mean 7 ± 22 ml vs. 7 ± 19 ml; p = 0.63).","[{'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Kyhl', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark. Electronic address: kasperkyhl@gmail.com.'}, {'ForeName': 'Kiril Aleksov', 'Initials': 'KA', 'LastName': 'Ahtarovski', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nepper-Christensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Ekström', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Adam Ali', 'Initials': 'AA', 'LastName': 'Ghotbi', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Schoos', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Göransson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Litten', 'Initials': 'L', 'LastName': 'Bertelsen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Helqvist', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Holmvang', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Frants', 'Initials': 'F', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Saunamäki', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Clemmensen', 'Affiliation': 'Department of Medicine, Nykoebing F Hospital, Nykoebing F and University of Southern Denmark, Odense, Denmark; University Clinic of Hamburg-Eppendorf, The Heart Centre, Hamburg, Germany.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'De Backer', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Dan Eik', 'Initials': 'DE', 'LastName': 'Høfsten', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbæk', 'Affiliation': 'Department of Cardiology, Zealand University, Roskilde, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Vejlstrup', 'Affiliation': 'Department of Cardiology, Zealand University, Roskilde, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Lønborg', 'Affiliation': 'Department of Cardiology, Zealand University, Roskilde, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark; Department of Cardiology, University of Lund, Lund, Sweden.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.01.248']
3540,31262544,Resting-state functional connectivity after hydrocortisone administration in patients with post-traumatic stress disorder and borderline personality disorder.,"In a previous study, we found that - in contrast to healthy individuals - patients with borderline personality disorder (BPD) and post-traumatic stress disorder (PTSD) showed better memory retrieval performance after hydrocortisone administration compared to placebo. As these results suggest an altered function of corticosteroid receptors in the brain in PTSD and BPD, we examined the effect of hydrocortisone on brain activation in both disorders. We recruited 40 female healthy controls, 20 female unmedicated patients with PTSD and 18 female unmedicated patients with BPD. We conducted a placebo-controlled cross-over study, in which all participants underwent two resting state MRI measurements after they received either a placebo or 10 mg hydrocortisone orally and in randomized order. There was a time interval of one week between the measurements. We analysed resting state functional connectivity (RSFC) with the hippocampus and the amygdala as seed regions. Compared to healthy controls, both patient groups showed reduced hippocampus RSFC to dorsomedial prefrontal cortex (dmPFC). Positive hippocampus dmPFC RSFC correlated negatively with childhood trauma (r = -0.47) and with severity of clinical symptoms, measured with the Borderline Symptom List (r = -0.44) and the Posttraumatic Stress Diagnostic Scale (r = -0.45). We found neither differences in amygdala RSFC nor an effect of hydrocortisone administration. Childhood trauma might lead to decreased positive hippocampus dmPFC RSFC. This might explain symptoms of PTSD and BPD that are characterized by dysfunctional fear regulation.",2019,"Compared to healthy controls, both patient groups showed reduced hippocampus RSFC to dorsomedial prefrontal cortex (dmPFC).","['40 female healthy controls, 20 female unmedicated patients with PTSD and 18 female unmedicated patients with BPD', 'healthy individuals - patients with borderline personality disorder (BPD) and post-traumatic stress disorder (PTSD', 'patients with post-traumatic stress disorder and borderline personality disorder']","['hydrocortisone', 'placebo']","['hippocampus RSFC to dorsomedial prefrontal cortex (dmPFC', 'Posttraumatic Stress Diagnostic Scale', 'memory retrieval performance', 'Positive hippocampus dmPFC RSFC', 'brain activation', 'severity of clinical symptoms']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0222045'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",40.0,0.0487814,"Compared to healthy controls, both patient groups showed reduced hippocampus RSFC to dorsomedial prefrontal cortex (dmPFC).","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany. Electronic address: sophie.metz@charite.de.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Fleischer', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Grimm', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany; MSB Medical School Berlin, Berlin, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Switzerland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Gärnter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany; MSB Medical School Berlin, Berlin, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Golde', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Institute of Cognitive Neuroscience, Department of Cognitive Psychology, Ruhr University Bochum, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.05.008']
3541,31997146,The Effects of Personalizing Colorectal Cancer Risk Communication on Risk Perceptions and Health Behavior Intentions: a Randomized Trial of Average-Risk Adults.,"Risk assessment tools may help individuals gauge cancer risk and motivate lifestyle and screening behavior changes. Despite the evermore common availability of such tools, little is known about their potential utility in average-risk population approaches to cancer prevention. We evaluated the effects of providing personalized (vs. generic) information concerning colorectal cancer (CRC) risk factors on average-risk individuals' risk perceptions and intentions to engage in three risk-reducing behaviors: CRC screening, diet, and physical activity. Further, we explored whether the receipt of CRC-specific risk assessment feedback influenced individuals' breast cancer risk perceptions and mammography intentions. Using an online survey, N = 419 survey respondents aged 50-75 with no personal or family history of CRC were randomized to receive an average estimate of CRC lifetime risk and risk factor information that was either personalized (treatment) or invariant/non-personalized (control). Respondent risk perceptions and behavioral intentions were ascertained before and after risk assessment administration. No differences were observed in risk perceptions or behavioral intentions by study arm. However, regardless of study arm, CRC screening intentions significantly increased after risk assessment feedback was provided. This occurred despite a significant reduction in risk perceptions. Results support the role simple cancer risk assessment information could play in promoting screening behaviors while improving the accuracy of cancer risk perceptions. Providing cancer risk assessment information may decrease individuals' perceptions of cancer risk to more realistic levels while simultaneously facilitating screening intentions among an average-risk population, regardless of whether provided risk information is personalized.",2020,No differences were observed in risk perceptions or behavioral intentions by study arm.,"[""individuals' breast cancer risk perceptions and mammography intentions"", 'Average-Risk Adults', '419 survey respondents aged 50-75 with no personal or family history of CRC']","['CRC lifetime risk and risk factor information that was either personalized (treatment) or invariant/non-personalized (control', 'Personalizing Colorectal Cancer Risk Communication', 'CRC-specific risk assessment feedback']","['Risk Perceptions and Health Behavior Intentions', 'Respondent risk perceptions and behavioral intentions', 'risk perceptions or behavioral intentions', 'CRC screening intentions', 'risk perceptions']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}]","[{'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018687'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",,0.0133177,No differences were observed in risk perceptions or behavioral intentions by study arm.,"[{'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Miller', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, and Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA. carrie.a.miller@vcuhealth.org.'}, {'ForeName': 'Jennifer Elston', 'Initials': 'JE', 'LastName': 'Lafata', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy and UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.'}, {'ForeName': 'Maria D', 'Initials': 'MD', 'LastName': 'Thomson', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, VA, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01694-5']
3542,31679821,Evaluation of OM3-PL/FFA Pharmacokinetics After Single and Multiple Oral Doses in Healthy Volunteers.,"PURPOSE


The US Food and Drug Administration has approved several omega-3 (OM3)-containing prescription drugs for the treatment of severe hypertriglyceridemia (HTG). However, there is still a need to develop formulations with high bioavailability irrespective of the fat content and time of the meal. OM3-phospholipid (PL)/free fatty acid (FFA) is an investigational drug for the treatment of severe HTG containing naturally derived krill oil mixture of OM3, mainly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as PL esters and as FFA. Both forms in OM3-PL/FFA are believed to be readily bioavailable. Per gram, OM3-PL/FFA contains a lower dose of EPA/DHA in comparison with already approved prescription drugs. The study aim was to evaluate OM3-PL/FFA pharmacokinetic (PK) properties after single and multiple oral doses of 1, 2, and 4 g in healthy subjects when receiving a Therapeutic Lifestyle Change (TLC) diet. The dose proportionality of the study drug, the effect of a high-fat (HF) meal on its PK properties and its safety profile after multiple administration were also explored.
METHODS


In this Phase I, open-label, randomized, multiple-dose, single-center, parallel-design study, 42 healthy volunteers following a TLC diet were randomly assigned into 1 of 3 treatment groups in a 1:1:1 ratio to receive a single dose at day 1, followed by multiple oral doses of 1, 2, and 4 g/d for 14 days. At day 15, all subjects received a HF breakfast.
FINDINGS


After once-daily dosing, based on graphic assessment, OM3-PL/FFA levels reached steady state within 7-10 days. Exposure of total EPA + DHA, total DHA, and total EPA (C max  and AUC) appeared to be approximately proportional over the 1-4 g/d dose range. After 14 days of repeated daily dosing, accumulation was observed and was greater at the higher dose of the study product. When administered after a HF breakfast on day 15, median t max , the geometric mean of AUC 0-24  and C max  were comparable with the values on day 14 across the 3 dose levels.
IMPLICATIONS


OM3-PL/FFA was found to be well tolerated in healthy subjects. The study drug PK properties appeared to be approximately dose proportional over the 1-4 g/d dose range. The bioavailability of OM3-PL/FFA did not appear to be meaningfully affected by the fat content of the meal consumed before dose administration. This is clinically relevant because a low-fat diet is part of the management of patients with HTG.",2019,The bioavailability of OM3-PL/FFA did not appear to be meaningfully affected by the fat content of the meal consumed before dose administration.,"['42 healthy volunteers following a TLC diet', 'Healthy Volunteers', 'healthy subjects when receiving a Therapeutic Lifestyle Change (TLC) diet', 'patients with HTG', 'severe hypertriglyceridemia (HTG', 'healthy subjects']","['OM3-phospholipid (PL)/free fatty acid (FFA', 'high-fat (HF) meal', 'OM3-PL/FFA Pharmacokinetics', 'HF breakfast']","['bioavailability of OM3-PL/FFA', 'OM3-PL/FFA pharmacokinetic (PK) properties', 'total EPA\xa0+\xa0DHA, total DHA, and total EPA (C max  and AUC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}]","[{'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",42.0,0.0400967,The bioavailability of OM3-PL/FFA did not appear to be meaningfully affected by the fat content of the meal consumed before dose administration.,"[{'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Lapointe', 'Affiliation': 'Acasti Pharma Inc, Laval, Quebec, Canada. Electronic address: j-f.lapointe@acastipharma.com.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Harvey', 'Affiliation': 'Acasti Pharma Inc, Laval, Quebec, Canada.'}, {'ForeName': 'Sarya', 'Initials': 'S', 'LastName': 'Aziz', 'Affiliation': 'Acasti Pharma Inc, Laval, Quebec, Canada.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hegele', 'Affiliation': 'Robarts Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Lemieux', 'Affiliation': 'Acasti Pharma Inc, Laval, Quebec, Canada.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.10.003']
3543,31036503,Morbidity and mortality after lifestyle intervention for people with impaired glucose tolerance: 30-year results of the Da Qing Diabetes Prevention Outcome Study.,"BACKGROUND


Lifestyle interventions can delay the onset of type 2 diabetes in people with impaired glucose tolerance, but whether this leads subsequently to fewer complications or to increased longevity is uncertain. We aimed to assess the long-term effects of lifestyle interventions in people with impaired glucose tolerance on the incidence of diabetes, its complications, and mortality.
METHODS


The original study was a cluster randomised trial, started in 1986, in which 33 clinics in Da Qing, China, were randomly assigned to either be a control clinic or provide one of three interventions (diet, exercise, or diet plus exercise) for 6 years for 577 adults with impaired glucose tolerance who usually receive their medical care from the clinics. Subsequently, participants were followed for up to 30 years to assess the effects of intervention on the incidence of diabetes, cardiovascular disease events, composite microvascular complications, cardiovascular disease death, all-cause mortality, and life expectancy.
FINDINGS


Of the 577 participants, 438 were assigned to an intervention group and 138 to the control group (one refused baseline examination). After 30 years of follow-up, 540 (94%) of 576 participants were assessed for outcomes (135 in the control group, 405 in the intervention group). During the 30-year follow-up, compared with control, the combined intervention group had a median delay in diabetes onset of 3·96 years (95% CI 1·25 to 6·67; p=0·0042), fewer cardiovascular disease events (hazard ratio 0·74, 95% CI 0·59-0·92; p=0·0060), a lower incidence of microvascular complications (0·65, 0·45-0·95; p=0·025), fewer cardiovascular disease deaths (0·67, 0·48-0·94; p=0·022), fewer all-cause deaths (0·74, 0·61-0·89; p=0·0015), and an average increase in life expectancy of 1·44 years (95% CI 0·20-2·68; p=0·023).
INTERPRETATION


Lifestyle intervention in people with impaired glucose tolerance delayed the onset of type 2 diabetes and reduced the incidence of cardiovascular events, microvascular complications, and cardiovascular and all-cause mortality, and increased life expectancy. These findings provide strong justification to continue to implement and expand the use of such interventions to curb the global epidemic of type 2 diabetes and its consequences.
FUNDING


US Centers for Disease Control and Prevention, WHO, Chinese Center for Disease Control and Prevention, World Bank, Ministry of Public Health of the People's Republic of China, Da Qing First Hospital, China-Japan Friendship Hospital, and National Center for Cardiovascular Diseases & Fuwai Hospital.",2019,"During the 30-year follow-up, compared with control, the combined intervention group had a median delay in diabetes onset of 3·96 years (95% CI 1·25 to 6·67; p=0·0042), fewer cardiovascular disease events (hazard ratio 0·74, 95% CI 0·59-0·92; p=0·0060), a lower incidence of microvascular complications (0·65, 0·45-0·95; p=0·025), fewer cardiovascular disease deaths (0·67, 0·48-0·94; p=0·022), fewer all-cause deaths (0·74, 0·61-0·89; p=0·0015), and an average increase in life expectancy of 1·44 years (95% CI 0·20-2·68; p=0·023).
","['1986, in which 33 clinics in Da Qing, China', '577 participants', '577 adults with impaired glucose tolerance who usually receive their medical care from the clinics', 'people with impaired glucose tolerance']","['lifestyle interventions', 'control clinic or provide one of three interventions (diet, exercise, or diet plus exercise', 'lifestyle intervention']","['cardiovascular disease events', 'incidence of cardiovascular events, microvascular complications, and cardiovascular and all-cause mortality, and increased life expectancy', 'life expectancy', 'incidence of diabetes, cardiovascular disease events, composite microvascular complications, cardiovascular disease death, all-cause mortality, and life expectancy', 'median delay in diabetes onset of 3·96 years', 'cardiovascular disease deaths', 'incidence of diabetes, its complications, and mortality', 'microvascular complications', 'Morbidity and mortality']","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",576.0,0.0715643,"During the 30-year follow-up, compared with control, the combined intervention group had a median delay in diabetes onset of 3·96 years (95% CI 1·25 to 6·67; p=0·0042), fewer cardiovascular disease events (hazard ratio 0·74, 95% CI 0·59-0·92; p=0·0060), a lower incidence of microvascular complications (0·65, 0·45-0·95; p=0·025), fewer cardiovascular disease deaths (0·67, 0·48-0·94; p=0·022), fewer all-cause deaths (0·74, 0·61-0·89; p=0·0015), and an average increase in life expectancy of 1·44 years (95% CI 0·20-2·68; p=0·023).
","[{'ForeName': 'Qiuhong', 'Initials': 'Q', 'LastName': 'Gong', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Division of Diabetes Translation, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Da Qing First Hospital, Da Qing, China.'}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Division of Non-Communicable Disease Control and Community Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'An', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xinxing', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Da Qing First Hospital, Da Qing, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yiling J', 'Initials': 'YJ', 'LastName': 'Cheng', 'Affiliation': 'Division of Diabetes Translation, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Gregg', 'Affiliation': 'Division of Diabetes Translation, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Yinghua', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiology, Da Qing First Hospital, Da Qing, China.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Bennett', 'Affiliation': 'Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Guangwei', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China; China-Japan Friendship Hospital, Beijing, China. Electronic address: guangwei_li45@126.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30093-2']
3544,31096275,Cuff-assisted versus cap-assisted colonoscopy for adenoma detection: results of a randomized study.,"BACKGROUND


The adenoma detection rate (ADR) is the most important marker of colonoscopy quality. Devices to improve adenoma detection have been developed, such as the Endocuff and transparent cap. The aim of the current study was to examine whether there was a difference in ADR between Endocuff-assisted (EAC) and cap-assisted colonoscopy (CAC).
METHODS


A randomized prospective trial was conducted. Eligible patients included adults ≥ 18 years referred because of symptoms, surveillance, or colonoscopies as part of the Bowel Cancer Screening Programme (BCSP). The primary outcome measure was ADR. Secondary outcomes included mean number of adenomas, mean number of polyps, polyp detection rate, cecal intubation rate, and time to cecal intubation. Procedural measures, device removal rate, and adverse events were also recorded.
RESULTS


A total of 711 patients (51.1 % men; median age 63 years) were included, of whom 357 patients were randomized to EAC and 354 patients to CAC. In the intention-to-treat analysis, the ADR was similar in both groups: EAC 50.4 % (95 % confidence interval [CI] 45.1 - 55.7) vs. CAC 50.6 % (95 %CI 45.2 - 55.9). Similar results were obtained in the per-protocol analysis: EAC 51.6 % (95 %CI 46.2 - 57) vs. CAC 51.4 % (95 %CI 46 - 56.8). There were no differences between the two devices in ADR according to the mean number of adenomas and polyps per procedure, polyp detection rate, cecal intubation rate, and time to cecal intubation. Device removal rate and adverse events were also similar.
CONCLUSION


In this randomized study, no differences in ADR were found between Endocuff- and cap-assisted colonoscopy.",2019,"There were no differences between the two devices in ADR according to the mean number of adenomas and polyps per procedure, polyp detection rate, cecal intubation rate, and time to cecal intubation.","['adenoma detection', 'Eligible patients included adults ≥\u200a18 years referred because of symptoms, surveillance, or colonoscopies as part of the Bowel Cancer Screening Programme (BCSP', 'and 354 patients to CAC', '711 patients (51.1\u200a% men; median age 63 years) were included, of whom 357 patients']","['EAC', 'Cuff-assisted versus cap-assisted colonoscopy', 'Endocuff- and cap-assisted colonoscopy', 'Endocuff-assisted (EAC) and cap-assisted colonoscopy (CAC']","['mean number of adenomas and polyps per procedure, polyp detection rate, cecal intubation rate, and time to cecal intubation', 'Procedural measures, device removal rate, and adverse events', 'ADR', 'Device removal rate and adverse events', 'mean number of adenomas, mean number of polyps, polyp detection rate, cecal intubation rate, and time to cecal intubation']","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0346627', 'cui_str': 'Cancer of Intestines'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0752250', 'cui_str': 'Device Removal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}]",711.0,0.308492,"There were no differences between the two devices in ADR according to the mean number of adenomas and polyps per procedure, polyp detection rate, cecal intubation rate, and time to cecal intubation.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sola-Vera', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Catalá', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Uceda', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Picó', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Pérez Rabasco', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Sáez', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Jiménez', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Arjona', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Fernández', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Girona', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}, {'ForeName': 'Mariana Fe', 'Initials': 'MF', 'LastName': 'García-Sepulcre', 'Affiliation': 'Gastroenterology Department, Hospital General Universitario de Elche, Elche, Spain.'}]",Endoscopy,['10.1055/a-0901-7306']
3545,31994638,Belief patterns and drug use in a sample of Brazilian youth: an exploratory latent class analysis.,"OBJECTIVE


Adolescent substance abuse is a public health concern worldwide, and its prevention is the subject of numerous programmatic efforts. Yet, little research exists on the structure of drug-related belief patterns in youth and their utility in preventive program planning. The aim of this study is to determine the structure of drug-related beliefs among 12-15-year-old students in Brazil using latent class analysis.
METHODS


De-identified survey data were obtained from the baseline sample (n=6,176) of a randomized controlled trial on the #Tamojunto drug use prevention program in Brazilian middle schools. Using 11 survey items assessing drug-related beliefs as indicators, four models were run and assessed for goodness-of-fit. For the best fitting model, demographic variables and substance use across latent classes were assessed.
RESULTS


Model fit statistics indicated that the best fit was a three-class solution, comprising a large Drug-Averse Beliefs class (80.9%), a smaller Permissive Beliefs class (12.7%), and an Inconsistent Beliefs class (6.4%). Respondents in the Permissive Beliefs and Inconsistent Beliefs classes reported greater past-year drug use, were slightly older and less likely to be female than those in the Drug-Averse Beliefs class.
CONCLUSIONS


These results indicate that conceptualizing drug beliefs as a categorical latent variable may be useful for informing prevention. Longitudinal studies are needed to establish temporality and assess further applicability of this construct.",2020,"Respondents in the Permissive Beliefs and Inconsistent Beliefs classes reported greater past-year drug use, were slightly older and less likely to be female than those in the Drug-Averse Beliefs class.
","['De-identified survey data were obtained from the baseline sample (n=6,176) of a randomized controlled trial on the #Tamojunto drug use prevention program in Brazilian middle schools', '12-15-year-old students in Brazil using latent class analysis']",[],['smaller Permissive Beliefs class'],"[{'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C4704739', 'cui_str': 'Latent Variable Modeling'}]",[],"[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",,0.022726,"Respondents in the Permissive Beliefs and Inconsistent Beliefs classes reported greater past-year drug use, were slightly older and less likely to be female than those in the Drug-Averse Beliefs class.
","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Healy', 'Affiliation': 'Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY, USA.'}, {'ForeName': 'Silvia S', 'Initials': 'SS', 'LastName': 'Martins', 'Affiliation': 'Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY, USA.'}, {'ForeName': 'Thiago M', 'Initials': 'TM', 'LastName': 'Fidalgo', 'Affiliation': 'Departamento de Psiquiatria, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Zila M', 'Initials': 'ZM', 'LastName': 'Sanchez', 'Affiliation': 'Departamento de Medicina Preventiva, UNIFESP, São Paulo, SP, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0706']
3546,32005622,"The Effect of the IPACK Block on Pain After Primary TKA: A Double-Blinded, Prospective, Randomized Trial.","BACKGROUND


The purpose of this study was to determine if infiltration of local anesthetic between the interspace between the popliteal artery and capsule of the knee (IPACK) provides benefit in total knee arthroplasty.
METHODS


Patients were randomized into continuous adductor canal block with IPACK block or continuous adductor canal block with sham subcutaneous saline injection. Only the anesthesiologist performing the block was aware of randomization status. After surgery, a blinded assessor recorded opioid consumption, pain scores, and gait distance.
RESULTS


There were 35 patients in the IPACK group and 34 in the NO IPACK group. There was no difference demographically between the groups. In the postanesthesia care unit (PACU), the average (P = .0122) and worst (P = .0168) pain scores at rest were statistically lower in the IPACK group. There was no difference in the pain scores during physical therapy (P = .2080). There was no difference in opioid consumption in the PACU (P = .7928), or at 24 hours (P = .7456). There was no difference in pain scores on POD 1 in the AM (P = .4597) or PM (P = .6273), or in the walking distance (P = .5197). There was also no difference in length of stay in the PACU (P = .9426) or hospital (P = .2141).
CONCLUSION


The IPACK group had lower pain scores at rest in the PACU, but this is likely not clinically significant. The routine use of the IPACK is not supported by the results of this study. There may be indications for the use of the IPACK block as a rescue block or in patients who have contraindications to our standard multimodal treatment regimen or in patients with chronic pain or opioid dependence.",2020,"There was no difference in opioid consumption in the PACU (P = .7928), or at 24 hours (P = .7456).","['After Primary TKA', 'patients who have contraindications to our standard multimodal treatment regimen or in patients with chronic pain or opioid dependence', 'Patients', '35 patients in the IPACK group and 34 in the NO IPACK group', 'total knee arthroplasty']","['continuous adductor canal block with IPACK block or continuous adductor canal block with sham subcutaneous saline injection', 'knee (IPACK', 'IPACK Block', 'IPACK']","['Pain', 'length of stay', 'opioid consumption', 'pain scores', 'opioid consumption, pain scores, and gait distance']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0009429', 'cui_str': 'Multimodal Treatment'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0524662', 'cui_str': 'Opiate Dependence'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",35.0,0.159555,"There was no difference in opioid consumption in the PACU (P = .7928), or at 24 hours (P = .7456).","[{'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Patterson', 'Affiliation': 'Department of Anesthesiology, Ochsner Medical Center, New Orleans, LA; The University of Queensland School of Medicine, Ochsner Clinical School, New Orleans, LA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Vitter', 'Affiliation': 'Department of Anesthesiology, Ochsner Medical Center, New Orleans, LA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Bland', 'Affiliation': 'Department of Anesthesiology, Ochsner Medical Center, New Orleans, LA.'}, {'ForeName': 'Bobby D', 'Initials': 'BD', 'LastName': 'Nossaman', 'Affiliation': 'Department of Anesthesiology, Ochsner Medical Center, New Orleans, LA; The University of Queensland School of Medicine, Ochsner Clinical School, New Orleans, LA.'}, {'ForeName': 'Leslie C', 'Initials': 'LC', 'LastName': 'Thomas', 'Affiliation': 'Department of Anesthesiology, Ochsner Medical Center, New Orleans, LA; The University of Queensland School of Medicine, Ochsner Clinical School, New Orleans, LA.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Chimento', 'Affiliation': 'The University of Queensland School of Medicine, Ochsner Clinical School, New Orleans, LA; Department of Orthopaedic Surgery, Ochsner Medical Center, New Orleans, LA.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.01.014']
3547,31348430,The Effects of Exposure Time on Systemic Inflammation in Subjects With Exposure to Zinc- and Copper-Containing Brazing Fumes.,"INTRODUCTION


Inhalation of copper and zinc containing brazing fumes (2.5 mg/m for 6 hours) is able to induce asymptomatic systemic inflammation which is supposed to be connected with an increased risk for cardiovascular disease. In this study it was investigated if inflammation can be prevented by reducing the exposure time.
METHODS


A total of 15 healthy male subjects were exposed to such brazing fumes in a crossover design for 3, 4, and 5 hours in randomized order. Before and 24 hours after exposure, blood samples were taken and c-reactive protein (CRP) as marker for an acute phase reaction was measured.
RESULTS


Five-hour exposure induced an increase of CRP, whereas the shorter exposure times did not result in a significant inflammatory reaction.
CONCLUSIONS


Reducing daily exposure times below 5 hours is able to prevent systemic inflammatory reactions.",2019,"RESULTS


Five hour exposure induced an increase of CRP, whereas the shorter exposure times did not result in a significant inflammatory reaction.
","['15 healthy male subjects', 'Subjects with Exposure to Zinc- and Copper-Containing Brazing Fumes']",[],"['CRP', 'Systemic Inflammation']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0337109', 'cui_str': 'Brazing (qualifier value)'}, {'cui': 'C0457553', 'cui_str': 'Fume (substance)'}]",[],"[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",15.0,0.0397094,"RESULTS


Five hour exposure induced an increase of CRP, whereas the shorter exposure times did not result in a significant inflammatory reaction.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brand', 'Affiliation': 'Institute of Occupational, Social and Environmental Medicine, Medical Faculty Aachen, RWTH Aachen, Aachen, Germany (Dr Brand, Beilmann, Thomas, Dr Kraus, Mr Krichel, Reisgen, and Dr Krabbe); ISF-Welding and Joining Institute, RWTH Aachen, Aachen, Germany (Mr Krichel and Ms Schmidt).'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Beilmann', 'Affiliation': ''}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraus', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Krichel', 'Affiliation': ''}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Reisgen', 'Affiliation': ''}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Krabbe', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001676']
3548,32019699,Beyond Performance Metrics: Automatic Deep Learning Retinal OCT Analysis Reproduces Clinical Trial Outcome.,"PURPOSE


To validate the efficacy of a fully automatic, deep learning-based segmentation algorithm beyond conventional performance metrics by measuring the primary outcome of a clinical trial for macular telangiectasia type 2 (MacTel2).
DESIGN


Evaluation of diagnostic test or technology.
PARTICIPANTS


A total of 92 eyes from 62 participants with MacTel2 from a phase 2 clinical trial (NCT01949324) randomized to 1 of 2 treatment groups METHODS: The ellipsoid zone (EZ) defect areas were measured on spectral domain OCT images of each eye at 2 time points (baseline and month 24) by a fully automatic, deep learning-based segmentation algorithm. The change in EZ defect area from baseline to month 24 was calculated and analyzed according to the clinical trial protocol.
MAIN OUTCOME MEASURE


Difference in the change in EZ defect area from baseline to month 24 between the 2 treatment groups.
RESULTS


The difference in the change in EZ defect area from baseline to month 24 between the 2 treatment groups measured by the fully automatic segmentation algorithm was 0.072±0.035 mm 2  (P = 0.021). This was comparable to the outcome of the clinical trial using semiautomatic measurements by expert readers, 0.065±0.033 mm 2  (P = 0.025).
CONCLUSIONS


The fully automatic segmentation algorithm was as accurate as semiautomatic expert segmentation to assess EZ defect areas and was able to reliably reproduce the statistically significant primary outcome measure of the clinical trial. This approach, to validate the performance of an automatic segmentation algorithm on the primary clinical trial end point, provides a robust gauge of its clinical applicability.",2020,"CONCLUSIONS


The fully automatic segmentation algorithm was as accurate as semiautomatic expert segmentation to assess EZ defect areas and was able to reliably reproduce the statistically significant primary outcome measure of the clinical trial.","['A total of 92 eyes from 62 participants with MacTel2 from a phase 2 clinical trial (NCT01949324', 'macular telangiectasia type 2 (MacTel2']","['ellipsoid zone (EZ) defect areas were measured on spectral domain OCT images of each eye at 2 time points (baseline and month 24) by a fully automatic, deep learning-based segmentation algorithm', 'fully automatic, deep learning-based segmentation algorithm beyond conventional performance metrics']",['change in EZ defect area'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1096779', 'cui_str': 'Clinical Trial, Phase 2'}, {'cui': 'C4521693', 'cui_str': 'Telangiectasia of macula lutea'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C4704761', 'cui_str': 'Deep Learning'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0700381', 'cui_str': 'Segmentation (qualifier value)'}, {'cui': 'C0002045'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",92.0,0.117519,"CONCLUSIONS


The fully automatic segmentation algorithm was as accurate as semiautomatic expert segmentation to assess EZ defect areas and was able to reliably reproduce the statistically significant primary outcome measure of the clinical trial.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Loo', 'Affiliation': 'Department of Biomedical Engineering, Duke University, Durham, North Carolina.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'Ophthalmology, Emmes, Rockville, Maryland.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, Bethesda, Maryland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Department of Molecular Medicine, The Scripps Research Institute, La Jolla, California; The Lowy Medical Research Institute, La Jolla, California.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Farsiu', 'Affiliation': 'Department of Biomedical Engineering, Duke University, Durham, North Carolina; Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina. Electronic address: sina.farsiu@duke.edu.'}]",Ophthalmology,['10.1016/j.ophtha.2019.12.015']
3549,30935742,Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials.,"BACKGROUND


The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.
METHODS


Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period.
RESULTS


Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race.
CONCLUSIONS


No safety concerns arose, supporting the favorable benefit-risk profile of RZV.",2019,"Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race.
","['Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years', 'herpes zoster in adults']","['RZV or placebo', 'placebo', 'recombinant zoster vaccine (RZV', 'Placebo', 'adjuvanted recombinant zoster vaccine']","['occurrence of overall SAEs', 'unsolicited AEs', 'Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs', 'Solicited and unsolicited adverse events (AEs', 'transient injection site and solicited systemic reactions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]",,0.548038,"Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race.
","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'López-Fauqued', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: marta.x.lopez-fauqed@gsk.com.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Campora', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: laura.e.campora@gsk.com.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Delannois', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: frederique.x.delannois@gsk.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Idrissi', 'Affiliation': 'GSK, Rixensart, Belgium. Electronic address: mohamed.s.elidrissi@gsk.com.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: cornelia.oostvogels@orange.fr.'}, {'ForeName': 'Ferdinandus J', 'Initials': 'FJ', 'LastName': 'De Looze', 'Affiliation': 'AusTrials Pty Ltd, Sherwood and School of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: f.delooze@trialworks.com.au.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Diez-Domingo', 'Affiliation': 'Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain. Electronic address: jdiezdomingo@gmail.com.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Heineman', 'Affiliation': 'GSK, King of Prussia, PA, USA. Electronic address: tch3768@gmail.com.'}, {'ForeName': 'Himal', 'Initials': 'H', 'LastName': 'Lal', 'Affiliation': 'GSK, King of Prussia, PA, USA. Electronic address: himallal@yahoo.com.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'McElhaney', 'Affiliation': 'Health Sciences North Research Institute, Sudbury, Ontario, Canada. Electronic address: jmcelhaney@hsnri.ca.'}, {'ForeName': 'Shelly A', 'Initials': 'SA', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: Shelly.McNeil@nshealth.ca.'}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Yeo', 'Affiliation': 'School of Medicine, University of Wollongong, Wollongong, Australia. Electronic address: wilf@uow.edu.au.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Tavares-Da-Silva', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: fernanda.tavares@gsk.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2019.03.043']
3550,31856049,First-line atezolizumab plus chemotherapy in treatment of extensive small cell lung cancer: a cost-effectiveness analysis from China.,"BACKGROUND


IMpower 133 trial first confirmed the efficacy and safety of adding atezolizumab or placebo to first-line treatment with chemotherapy in patients with extensive-stage small-cell lung cancer (SCLC). While, overprice limited its broad use in clinical. The aim of this study was to evaluate the cost-effectiveness of atezolizumab plus chemotherapy in treatment of extensive SCLC as first line in China.
METHODS


A Markov model was established by extracting data from the IMpower 133 trial with untreated extensive SCLC patients. Utility values were obtained from published studies, and the costs were acquired from real world and literature. Additionally, sensitivity analyses based on a willingness-to-pay (WTP) threshold were performed to identify the uncertain parameters of Markov model.
RESULTS


Total costs of atezolizumab group were $48,129, while cost of chemotherapy alone was just $12,920 in placebo group. The quality-adjusted life-years (QALYs) in atezolizumab group was just 0.072 higher than that in placebo group (0.858 QALYs vs. 0.786 QALYs). The cost-effectiveness ratio between atezolizumab combination with chemotherapy and chemotherapy alone was $489,013/QALY in China. The net benefit of placebo group was significantly higher than atezolizumab group. One-way sensitivity analyses highlighted that utilities of the progression-free survival (PFS) and progression disease state in placebo group were the most influential parameter.
CONCLUSIONS


Atezolizumab combination therapy was not more cost-effective than chemotherapy alone at a WTP threshold of $25,929/QALY in China.",2019,The quality-adjusted life-years (QALYs) in atezolizumab group was just 0.072 higher than that in placebo group (0.858 QALYs vs. 0.786 QALYs).,"['patients with extensive-stage small-cell lung cancer (SCLC', 'extensive small cell lung cancer']","['atezolizumab combination with chemotherapy and chemotherapy', 'atezolizumab or placebo', 'chemotherapy', 'atezolizumab', 'Atezolizumab combination therapy', 'atezolizumab plus chemotherapy', 'placebo']","['progression-free survival (PFS) and progression disease state', 'cost-effective', 'efficacy and safety', 'quality-adjusted life-years (QALYs', 'cost-effectiveness', 'cost-effectiveness ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0836499,The quality-adjusted life-years (QALYs) in atezolizumab group was just 0.072 higher than that in placebo group (0.858 QALYs vs. 0.786 QALYs).,"[{'ForeName': 'Ling-Yu', 'Initials': 'LY', 'LastName': 'Li', 'Affiliation': 'The Cancer Center of the First Hospital of Jilin University, Changchun, Jilin 130021, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Wen-Qian', 'Initials': 'WQ', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Jiu-Wei', 'Initials': 'JW', 'LastName': 'Cui', 'Affiliation': ''}]",Chinese medical journal,['10.1097/CM9.0000000000000536']
3551,32012319,"Effect of brain training through visual mirror feedback, action observation and motor imagery on orofacial sensorimotor variables: A single-blind randomized controlled trial.","OBJECTIVES


The main objective was to evaluate the effects of action observation (AO), visual mirror feedback (VMF) and motor imagery (MI), combined with an oro-facial exercise programme, on sensorimotor variables in asymptomatic participants.
METHODS


We designed a randomised, single-blind, controlled trial that included 52 asymptomatic participants who were randomly assigned to 4 groups, 13 to each of the VMF, MI and AO groups and 13 to the control group (CG), which only performed the exercise programme. The primary outcomes were pain pressure sensitivity and tongue muscle strength. The secondary outcomes were maximum mouth opening, tongue length and the ability to generate mental motor images. Each group underwent a 3-session intervention using their respective exercise. Measurements were performed before starting the intervention and after each of the 3 sessions (pre, mid1, mid2 and post).
RESULTS


ANOVA revealed significant changes in PPTs in the masseter muscle region in the MI and AO groups in the pre-post and mid1-post changes. ANOVA revealed significant differences in tongue muscle strength in the anterior direction only in the AO group in the pre-mid2 and pre-post changes.
CONCLUSIONS


AO and MI, in conjunction with exercise, could induce changes in PPTs for the masseter muscle. In addition, only AO produced changes in tongue muscle strength. More research is needed to determine the role of brain representation techniques in the oro-facial region and transferring this exercise to the rehabilitation setting.",2020,"ANOVA revealed significant differences in tongue muscle strength in the anterior direction only in the AO group in the pre-mid2 and pre-post changes.
","['asymptomatic participants', '52 asymptomatic participants who were randomly assigned to 4 groups, 13 to each of the VMF, MI, and AO groups and 13 to the']","['action observation (AO), visual mirror feedback (VMF), and motor imagery (MI), combined with an orofacial exercise program', '3-session intervention using their respective exercise', 'control group (CG), which only performed the exercise program', 'brain training']","['pain pressure sensitivity and tongue muscle strength', 'maximum mouth opening, tongue length, and the ability to generate mental motor images', 'tongue muscle strength']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",52.0,0.0680824,"ANOVA revealed significant differences in tongue muscle strength in the anterior direction only in the AO group in the pre-mid2 and pre-post changes.
","[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'La Touche', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Herranz-Gómez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Destenay', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Gey-Seedorf', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cuenca-Martínez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Paris-Alemany', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Suso-Martí', 'Affiliation': 'Motion in Brains Research Group, Institute of Neuroscience and Sciences of the Movement (INCIMOV), Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}]",Journal of oral rehabilitation,['10.1111/joor.12942']
3552,31295222,"Type-Specific Human Papillomavirus Prevalence, Incident Cases, Persistence, and Associated Pregnancy Outcomes Among HIV-Infected Women in Kenya.","BACKGROUND


Persistent infection with high-risk types of human papillomavirus (HPV) is the preeminent factor driving the development of cervical cancer. There are large gaps in knowledge about both the role of pregnancy in the natural history of HPV infection and the impact of HPV on pregnancy outcomes.
METHODS


This single-site prospective cohort substudy, nested within an international multisite randomized controlled trial, assessed prevalence, incident cases, and persistence of type-specific HPV infection, and the association between persistence of high-risk HPV infection with pregnancy outcomes among HIV-infected pregnant women in Kenya, including HIV transmission to infants. Type-specific HPV was assessed using a line probe assay in pregnancy and again at 3 months after delivery. HIV status of children was determined using polymerase chain reaction at 6 weeks.
RESULTS


In total, 84.1% (206/245) of women had a high-risk HPV infection at enrollment. Three quarters (157/206) of these infections persisted postpartum. Persistence of HPV16 and/or HPV18 types was observed in more than half (53.4%; 39/73) of women with this infection at enrollment. Almost two-thirds had an incident high-risk HPV infection postpartum, which was not present in pregnancy (62.5%), most commonly HPV52 (19.0%). After adjustments, no association was detected between persistent high-risk HPV and preterm birth. All mothers of the 7 cases of infant HIV infection had persistent high-risk HPV infection (P = 0.044).
CONCLUSIONS


High levels of high-risk HPV infection and type-specific persistence were documented, heightening the urgency of mass role out of HPV vaccination. The association between HPV persistence and HIV transmission is a novel finding, warranting further study.",2019,"All mothers of the 7 cases of infant HIV infection had persistent high-risk HPV infection (P = 0.044).
","['HIV-Infected Women in Kenya', 'HIV-infected pregnant women in Kenya, including HIV transmission to infants']",['HPV16'],"['persistent high-risk HPV infection', 'incident high-risk HPV infection postpartum', 'persistent high-risk HPV and preterm birth', 'high-risk HPV infection']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}]",,0.166128,"All mothers of the 7 cases of infant HIV infection had persistent high-risk HPV infection (P = 0.044).
","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Vyankandondera', 'Affiliation': ''}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Wambua', 'Affiliation': 'International Centre for Reproductive Health.'}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Irungu', 'Affiliation': 'International Centre for Reproductive Health.'}, {'ForeName': 'Kishor', 'Initials': 'K', 'LastName': 'Mandaliya', 'Affiliation': ''}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Temmerman', 'Affiliation': ''}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': ''}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Mohamed', 'Affiliation': ''}, {'ForeName': 'Davy', 'Initials': 'D', 'LastName': 'Vanden Broeck', 'Affiliation': ''}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Verhelst', 'Affiliation': 'Ghent University, Ghent, Belgium.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Chersich', 'Affiliation': ''}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Luchters', 'Affiliation': ''}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001029']
3553,31688572,"Early onset of action with a 17β-estradiol, softgel, vaginal insert for treating vulvar and vaginal atrophy and moderate to severe dyspareunia.","OBJECTIVE


The softgel 17β-estradiol (E2) vaginal inserts (4 and 10 μg; Imvexxy; TherapeuticsMD, Boca Raton, FL) are FDA approved for treating moderate to severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy (VVA). The objective here was to determine responder rates at week 2 and whether week-2 findings predicted week-12 responders in the REJOICE trial.
METHODS


Postmenopausal women received E2 vaginal inserts 4, 10, or 25 μg, or placebo for 12 weeks. Proportion of responders (having ≥2 of the following: vaginal superficial cells >5%, vaginal pH <5.0, or dyspareunia improvement of ≥1 category) were calculated. Odds ratios (ORs) for positive response at week 12 given a positive response at week 2 were determined in the efficacy evaluable (EE) population.
RESULTS


The responder rate (in EE population [n = 695]) was 74% to 82% with E2 inserts versus 24% with placebo at week 2, and 72% to 80% versus 33% at week 12. Positive treatment responses were 9- to 14-fold higher with vaginal E2 than with placebo at week 2, and 5- to 8-fold higher at week 12. Response at week 2 predicted response at week 12 in the total population (OR 13.1; 95% CI, 8.8-19.7) and with active treatment only (OR 7.9; 95% CI, 4.7-13.2).
CONCLUSIONS


A high percentage of postmenopausal women with moderate to severe dyspareunia responded with the E2 softgel vaginal insert at week 2, and a positive response at week 2 predicted a positive response at week 12.",2019,"Positive treatment responses were 9- to 14-fold higher with vaginal E2 than with placebo at week 2, and 5- to 8-fold higher at week 12.","['Postmenopausal women received E2 vaginal inserts 4, 10, or 25\u200aμg, or', 'postmenopausal women with moderate to severe dyspareunia']","['placebo', 'softgel 17β-estradiol (E2) vaginal inserts (4 and 10\u200aμg; Imvexxy; TherapeuticsMD, Boca Raton, FL']","['Odds ratios (ORs) for positive response', 'responder rates', 'responder rate']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1719963', 'cui_str': 'Conventional release vaginal insert'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1719963', 'cui_str': 'Conventional release vaginal insert'}, {'cui': 'C4704162', 'cui_str': 'Imvexxy'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",,0.173882,"Positive treatment responses were 9- to 14-fold higher with vaginal E2 than with placebo at week 2, and 5- to 8-fold higher at week 12.","[{'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Constantine', 'Affiliation': 'EndoRheum Consultants, LLC, Malvern, PA.'}, {'ForeName': 'Leah S', 'Initials': 'LS', 'LastName': 'Millheiser', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaunitz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, FL.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Parish', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Graham', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001394']
3554,31688575,Improved periodontal disease and prevention of tooth loss in osteoporosis patients receiving once-yearly zoledronic acid: a randomized clinical trial.,"OBJECTIVE


This randomized, clinical trial investigated whether zoledronic acid combined with oral health maintenance can improve periodontal disease associated with osteoporosis, thus reducing the risk of tooth loss.
METHODS


Participants were those of the ZONE (ZOledroNate treatment in efficacy to osteoporosis) study. None of the participants had symptomatic periodontal disease at baseline. Participants received either zoledronic acid (5 mg; n = 333 [male 21, female 312]) or placebo (n = 332 [male 19, female 313]) once yearly for 2 years, and their age was 74.0 ± 5.3 (65-88) and 74.3 ± 5.4 (65-87) years, respectively. Participants were instructed to maintain good oral hygiene at baseline and every 3 months. Participants with signs or symptoms involving their oral cavity at the monthly visit with their physician were referred to dentists for examination of oral disease. All cases were included to analyze adverse events in this study. Testing for significance was conducted using Fisher exact test (P < 0.05).
RESULTS


The incidence of oral adverse events was significantly higher in the control group (67 cases, 20.2%) than in the zoledronic acid group (47 cases, 14.1%; P = 0.04). The frequency of symptomatic periodontal disease observed during the study was significantly higher in the control group (40 cases, 12.0%) than in the zoledronic acid group (18 cases, 5.4%; P = 0.002). Loss of teeth was more frequent in the control group (36 cases, 10.8%) than in the zoledronic acid group (24 cases, 7.2%), although the difference was not significant.
CONCLUSIONS


Zoledronic acid effectively prevented symptomatic periodontal disease in patients with osteoporosis who maintained good oral hygiene. : Video Summary: Supplemental Digital Content 1, http://links.lww.com/MENO/A438.",2019,"Loss of teeth was more frequent in the control group (36 cases, 10.8%) than in the zoledronic acid group (24 cases, 7.2%), although the difference was not significant.
","['patients with osteoporosis who maintained good oral hygiene', 'Participants with signs or symptoms involving their oral cavity at the monthly visit with their physician were referred to dentists for examination of oral disease', 'osteoporosis patients receiving once-yearly', 'n\u200a=\u200a332 [male 19, female 313]) once yearly for 2 years, and their age was 74.0\u200a±\u200a5.3 (65-88) and 74.3\u200a±\u200a5.4 (65-87) years, respectively', '5\u200amg; n\u200a=\u200a333 [male 21, female 312]) or', 'Participants were those of the']","['ZONE (ZOledroNate treatment', 'placebo', 'Zoledronic acid', 'zoledronic acid combined with oral health maintenance', 'zoledronic acid', ' Video Summary: Supplemental Digital Content 1, http://links.lww.com/MENO/A438']","['incidence of oral adverse events', 'symptomatic periodontal disease', 'frequency of symptomatic periodontal disease', 'periodontal disease and prevention of tooth loss', 'Loss of teeth']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0457639', 'cui_str': 'Good oral hygiene (finding)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0226896', 'cui_str': 'Cavitas Oris'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0420354', 'cui_str': 'Referred to dentist (finding)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C4517724', 'cui_str': 'Three hundred and thirty-three'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}]","[{'cui': 'C0392938', 'cui_str': 'Zoledronate (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0150289', 'cui_str': 'Oral health maintenance'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0080233', 'cui_str': 'Tooth Loss'}]",,0.0557918,"Loss of teeth was more frequent in the control group (36 cases, 10.8%) than in the zoledronic acid group (24 cases, 7.2%), although the difference was not significant.
","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Taguchi', 'Affiliation': 'Department of Oral and Maxillofacial Radiology, Matsumoto Dental University, Nagano, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Shiraki', 'Affiliation': 'Research Institute and Practice for Involutional Diseases, Nagano, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Asahi Kasei Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Hideyo', 'Initials': 'H', 'LastName': 'Ohshige', 'Affiliation': 'Asahi Kasei Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Touto Sangenjaya Rehabilitation Hospital, Tokyo, Japan.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001393']
3555,31343149,"In-season in-field variable resistance training: effects on strength, power, and anthropometry of junior soccer players.","BACKGROUND


Soccer players' leg muscular strength and power have been shown to be significant due to their association with soccer-specific performance including jumps, sprints, tackles and kicks. The aim of this study, therefore, was to examine the effects of an in-season in-field variable resistance training (VRT) program on strength, power, and anthropometry of junior soccer players.
METHODS


A team of male soccer players were randomly assigned into Experimental (N.=10) and Control groups (N.=10). The Control group performed 8 weeks of soccer training alone. The Experimental group performed squat VRT using chains in addition to soccer training. Measures before and after training included squat strength, countermovement jump, and anthropometric estimation of thigh muscle cross sectional area (CSA).
RESULTS


The VRT induced large improvements in absolute (34.45%; P=0.001; Cohen's d=1.78) and relative strength to thigh muscle CSA (21.53%; P=0.002; Cohen's d=1.04). Similarly, there were large (18.07%, P=0.007; Cohen's d=1.5) increases in jump height and medium gains in absolute peak power output (16.13%; P=0.009; Cohen's d=0.34) and relative peak power output to thigh muscle CSA (9.6%; P=0.002; Cohen's d=0.31). Further, there was a medium increase (5.9%, P=0.03; Cohen's d=0.36) in thigh muscle CSA. No significant changes were observed in the Control group.
CONCLUSIONS


In-season in-field biweekly squat VRT enhanced strength and power measures in junior soccer players.",2020,The VRT induced large improvements in absolute (34.45%; p=0.001; Cohen's d=1.78) and relative strength to thigh muscle CSA (21.53%; p=0.002; Cohen's d=1.04).,"['A team of male soccer players', 'junior soccer players']","['season in- field variable resistance training (VRT) program', 'squat VRT using chains in addition to soccer training', 'soccer training alone']","['strength and power measures', 'jump height and medium gains in absolute peak power output', 'strength, power, and anthropometry', 'relative strength to thigh muscle CSA', 'repetition maximum (1RM) of squat, countermovement jump (CMJ), and anthropometric estimation of thigh muscle cross sectional area (CSA']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}]","[{'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",,0.0217341,The VRT induced large improvements in absolute (34.45%; p=0.001; Cohen's d=1.78) and relative strength to thigh muscle CSA (21.53%; p=0.002; Cohen's d=1.04).,"[{'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Izadi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, Rasht, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Arazi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, Rasht, Iran - amid.arazi@guilan.ac.ir.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Laboratory of Human Performance, Quality of Life and Wellness Research Group, Department of Physical Activity Sciences, Universidad de Los Lagos, Osorno, Chile.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mirzaei', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, Rasht, Iran.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Saidie', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, Rasht, Iran.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.19.09937-7']
3556,31787434,Epiaortic Ultrasound for Assessment of Intraluminal Atheroma; Insights from the REGROUP Trial.,"OBJECTIVES


To assess the use of epiaortic ultrasound in contemporary cardiac surgery, as well as its impact on surgical cannulation strategy and cerebrovascular events.
DESIGN


Epiaortic ultrasound data was prospectively collected in the Randomized Endovein Graft Prospective (REGROUP) trial (VA Cooperative Studies Program #588, ClinicalTrials.gov, NCT01850082), which randomized 1,150 coronary artery bypass graft patients between 2014 and 2017 to endoscopic or open-vein graft harvest.
SETTING


Sixteen cardiac surgery programs within the Veterans Affairs Healthcare System with expertise at performing endoscopic vein-graft harvesting.
PARTICIPANTS


Veterans Affairs patients, greater than 18 years of age, undergoing elective or urgent coronary artery bypass grafting with cardiopulmonary bypass and cardioplegic arrest with at least one planned saphenous vein graft were eligible for enrollment.
INTERVENTIONS


Epiaortic ultrasound was performed by the surgeon using a high frequency (>7 MHz) ultrasound transducer. Two-dimensional images of the ascending aorta in multiple planes were acquired before aortic cannulation and cross-clamping.
MEASUREMENTS AND MAIN RESULTS


Epiaortic ultrasound was performed in 34.1% (269 of 790) of patients in REGROUP. Among these patients, simple intraluminal atheroma was observed in 21.9% (59 269), and complex intraluminal atheroma comprised 2.2% (6 of 269). The aortic cannulation or cross-clamp strategy was modified based on these findings in 7.1% of cases (19 of 269). There was no difference in stroke between patients who underwent epiaortic ultrasound and those who did not (1.9% v 1.2% p = 0.523).
CONCLUSIONS


Despite current guidelines recommending routine use of epiaortic ultrasound (IIa/B) to reduce the risk of stroke in cardiac surgery, in this contemporary trial, use remains infrequent, with significant site-to-site variability.",2020,"There was no difference in stroke between patients who underwent epiaortic ultrasound and those who did not (1.9% v 1.2% p = 0.523).
","['Veterans Affairs patients, greater than 18 years of age, undergoing elective or urgent coronary artery bypass grafting with cardiopulmonary bypass and cardioplegic arrest with at least one planned saphenous vein graft were eligible for enrollment', 'Sixteen cardiac surgery programs within the Veterans Affairs Healthcare System with expertise at performing endoscopic vein-graft harvesting', '1,150 coronary artery bypass graft patients between 2014 and 2017 to']","['epiaortic ultrasound (IIa/B', 'endoscopic or open-vein graft harvest', 'epiaortic ultrasound']","['stroke', 'simple intraluminal atheroma']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft (substance)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal (qualifier value)'}, {'cui': 'C0264956', 'cui_str': 'Atheromatous Plaques'}]",1150.0,0.0730764,"There was no difference in stroke between patients who underwent epiaortic ultrasound and those who did not (1.9% v 1.2% p = 0.523).
","[{'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Shapeton', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD. Electronic address: alexander.shapeton@va.gov.'}, {'ForeName': 'Kay B', 'Initials': 'KB', 'LastName': 'Leissner', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD.'}, {'ForeName': 'Suzana M', 'Initials': 'SM', 'LastName': 'Zorca', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD.'}, {'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Amirfarzan', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Stock', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD.'}, {'ForeName': 'Kousick', 'Initials': 'K', 'LastName': 'Biswas', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Haime', 'Affiliation': 'Division of Cardiac Surgery, Veterans Affairs Boston Healthcare System and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Srinivasa', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Veterans Affairs Boston Healthcare System and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Jacquelyn A', 'Initials': 'JA', 'LastName': 'Quin', 'Affiliation': 'Division of Cardiac Surgery, Veterans Affairs Boston Healthcare System and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Zenati', 'Affiliation': 'Division of Cardiac Surgery, Veterans Affairs Boston Healthcare System and Harvard Medical School, Boston, MA.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.10.053']
3557,32097203,Comparison of cell salvage with one and two suction devices during cesarean section in patients with placenta previa and/or accrete: a randomized controlled trial.,"BACKGROUND


Cell salvage has recently been recommended for obstetric use in cases with a high risk of massive hemorrhage during cesarean section (CS). However, limited data are available to support the use of one suction device to collect lost blood. This study aimed to investigate the volume of red blood cells (RBCs) salvaged and the components of amniotic fluid (AF) in blood salvaged by one suction device or two devices during CS in patients with placenta previa and/or accrete.
METHODS


Thirty patients with placenta previa and/or accrete undergoing elective CS in the Women's Hospital of Zhejiang University School of Medicine were recruited for the present study from November 1, 2017 to December 1, 2018. The patients were randomly assigned to one of the two groups according to an Excel-generated random number sheet: Group 1 (n = 15), in which only one suction device was used to aspirate all blood and AF, and Group 2 (n = 15), in which a second suction device was mainly used to aspirate AF before the delivery of the placenta. Three samples of blood per patient (pre-wash, post-wash, and post-filtration) were collected to measure AF components. The salvaged RBC volumes were recorded. Continuous data of pre-wash, post-wash, and post-filtration samples were analyzed by using one-way analysis of variance with Tukey's test for multiple comparisons, or Kruskal-Wallis test with Dunn test for multiple comparisons. Comparisons of continuous data between Group 1 and Group 2 were conducted using Student's t test or Mann-Whitney U test.
RESULTS


The salvaged RBC volume was significantly higher in Group 1 than that in Group 2 (401.6 ± 77.2 mL vs. 330.1 ± 53.3 mL, t = 4.175, P < 0.001). In both groups, squamous cells, lamellar bodies, and fat were significantly reduced by washing (all P<0.001) and squamous cells were further reduced by filtering (P < 0.001). Squamous cells were found in six post-filtration samples (three from each group). Lamellar bodies and fat were completely removed by filtering. Insulin-like growth factor binding protein 1, alpha-fetoprotein, albumin, lactate dehydrogenase, and potassium were significantly reduced post-wash (all P < 0.05), with no further significant reduction after filtration in either group (all P > 0.05). The mean percentage of fetal RBCs post-filtration was (1.8 ± 0.8)% with a range of 1.0% to 3.5% and (1.9 ± 0.9)% with a range of 0.7% to 4.0% in Groups 1 and 2, respectively, showing no significant difference between the two groups (U = 188.5, P = 0.651).
CONCLUSION


Cell salvage performed by one suction device could result in higher volume of salvaged RBCs and can be used safely for CS in patients with placenta previa and/or accrete when massive hemorrhage occurs.
TRIAL REGISTRATION NUMBER


ChiCTR-INR-17012926, http://www.chictr.org.cn/ Chinese Clinical Trial Registry.",2020,"In both groups, squamous cells, lamellar bodies, and fat were significantly reduced by washing (all P<0.001) and squamous cells were further reduced by filtering (P < 0.001).","['cases with a high risk of massive hemorrhage during cesarean section (CS', 'patients with placenta previa and/or accrete', ""Thirty patients with placenta previa and/or accrete undergoing elective CS in the Women's Hospital of Zhejiang University School of Medicine were recruited for the present study from November 1, 2017 to December 1, 2018""]","['Excel-generated random number sheet: Group 1 (n\u200a=\u200a15), in which only one suction device was used to aspirate all blood and AF', 'cell salvage with one and two suction devices']","['squamous cells, lamellar bodies, and fat', 'salvaged RBC volume', 'mean percentage of fetal RBCs post-filtration', 'salvaged RBC volumes', 'Insulin-like growth factor binding protein 1, alpha-fetoprotein, albumin, lactate dehydrogenase, and potassium']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0333279', 'cui_str': 'Massive hemorrhage (morphologic abnormality)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032046', 'cui_str': 'Placenta Previa'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2740529', 'cui_str': 'Excel'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439643', 'cui_str': 'Sheets (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0370199', 'cui_str': 'Aspirate'}, {'cui': 'C0005768'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}]","[{'cui': 'C0221910', 'cui_str': 'Squamous Cells'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0123256', 'cui_str': 'IGFBP-1'}, {'cui': 'C0002210', 'cui_str': 'alpha-Fetoproteins'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}]",30.0,0.0970965,"In both groups, squamous cells, lamellar bodies, and fat were significantly reduced by washing (all P<0.001) and squamous cells were further reduced by filtering (P < 0.001).","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310006, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310006, China.""}, {'ForeName': 'Pei-Xin', 'Initials': 'PX', 'LastName': 'Luo', 'Affiliation': ""Department of Clinical Laboratory, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310006, China.""}, {'ForeName': 'Yi-Fang', 'Initials': 'YF', 'LastName': 'Shen', 'Affiliation': ""Department of Clinical Laboratory, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310006, China.""}, {'ForeName': 'Chang-Cheng', 'Initials': 'CC', 'LastName': 'Lyu', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310006, China.""}, {'ForeName': 'Xiao-Wei', 'Initials': 'XW', 'LastName': 'Qian', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310006, China.""}, {'ForeName': 'Xin-Zhong', 'Initials': 'XZ', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310006, China.""}]",Chinese medical journal,['10.1097/CM9.0000000000000699']
3558,32197107,"Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2-17 years: a randomised, placebo-controlled, phase 2 trial.","BACKGROUND


An unmet clinical need remains for an effective tetravalent dengue vaccine suitable for all age groups, regardless of serostatus. We assessed the immunogenicity and safety of three different dose schedules of a tetravalent dengue vaccine (TAK-003) over a 48-month period in children living in dengue-endemic countries.
METHODS


We did a large, phase 2, double-blind, placebo-controlled trial at three sites in the Dominican Republic, Panama, and the Philippines. Healthy participants aged 2-17 years were randomly assigned 1:2:5:1 using an interactive web response system with stratification by age to receive either a two-dose primary series (days 1 and 91), one primary dose (day 1), one primary dose plus booster (days 1 and 365), or placebo. Participants and relevant study personnel were masked to the random assignment until completion of the study at month 48. To maintain masking, TAK-003 recipients were administered placebo doses when appropriate. The primary objective was assessment of neutralising geometric mean titres for each serotype to month 48 assessed in the per-protocol immunogenicity subset. Secondary safety endpoints included proportions of participants with serious adverse events and symptomatic virologically confirmed dengue. This study is registered with ClinicalTrials.gov, NCT02302066.
FINDINGS


Between Dec 5, 2014, and Feb 13, 2015, 1800 children were randomly assigned to the following groups: two-dose primary series (n=201), one primary dose (n=398), one primary dose plus 1-year booster (n=1002), and placebo (n=199). Of them, 1479 (82%) participants completed the 48-month study. Immunogenicity endpoints were assessed in 562 participants enrolled in the immunogenicity subset, of whom 509 were included in the per-protocol subset. At month 48, antibody titres remained elevated in all TAK-003 groups compared with placebo, irrespective of baseline serostatus. At month 48, geometric mean titres were 378 (95% CI 226-632) in two-dose, 421 (285-622) in one-dose, 719 (538-960) in one-dose plus 1-year booster, and 100 (50-201) in placebo recipients against DENV 1; 1052 (732-1511), 1319 (970-1794), 1200 (927-1553), and 208 (99-437) against DENV 2; 183 (113-298), 201 (135-298), 288 (211-392), and 71 (37-139) against DENV 3; and 152 (97-239), 164 (114-236), 219 (165-290), and 46 (26-82) against DENV 4; and tetravalent seropositivity rate was 89% (79-96), 86% (80-92), 97% (93-99), and 60% (47-72), respectively. Virologically confirmed dengue was recorded in 37 (2%) TAK-003 and 13 (7%) placebo participants, with a relative risk of 0·35 (0·19-0·65). No vaccine-related serious adverse events or severe dengue virus disease were reported.
INTERPRETATION


TAK-003 elicited antibody responses against all four serotypes, which persisted to 48 months post-vaccination, regardless of baseline serostatus. No important safety risks were identified. We observed a long-term reduction in risk of symptomatic dengue virus disease in vaccinees. Results from this study provide a long-term safety database and support assessment of the vaccine in the ongoing phase 3 efficacy study.
FUNDING


Takeda Vaccines.",2020,"At month 48, antibody titres remained elevated in all TAK-003 groups compared with placebo, irrespective of baseline serostatus.","['1800 children', '562 participants enrolled in the immunogenicity subset, of whom 509 were included in the per-protocol subset', 'children aged 2-17 years', 'Healthy participants aged 2-17 years', 'children living in dengue-endemic countries', 'vaccinees', 'Of them, 1479 (82%) participants completed the 48-month study']","['tetravalent dengue vaccine (TAK-003', 'placebo', 'tetravalent dengue vaccine']","['geometric mean titres', 'proportions of participants with serious adverse events and symptomatic virologically confirmed dengue', 'tetravalent seropositivity rate', 'neutralising geometric mean titres', 'Safety and immunogenicity', 'immunogenicity and safety', 'antibody titres']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}]",562.0,0.773625,"At month 48, antibody titres remained elevated in all TAK-003 groups compared with placebo, irrespective of baseline serostatus.","[{'ForeName': 'Vianney', 'Initials': 'V', 'LastName': 'Tricou', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland. Electronic address: vianney.tricou@takeda.com.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Sáez-Llorens', 'Affiliation': 'Hospital del Niño Dr José Renán Esquivel, Panama City, Panama; Sistema Nacional de Investigación, Secretaría Nacional de Ciencia, Tecnología e Innovación, Panama City, Panama.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'De La Salle Health Sciences Institute, Cavite, Philippines.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Rivera', 'Affiliation': 'Hospital Universitario Maternidad Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Jimeno', 'Affiliation': 'Centro de Vacunación Internacional (Cevaxin), Panama City, Panama.'}, {'ForeName': 'Ana Cecilia', 'Initials': 'AC', 'LastName': 'Villarreal', 'Affiliation': 'Centro de Vacunación Internacional (Cevaxin), Panama City, Panama.'}, {'ForeName': 'Epiphany', 'Initials': 'E', 'LastName': 'Dato', 'Affiliation': 'De La Salle Health Sciences Institute, Cavite, Philippines.'}, {'ForeName': 'Onix', 'Initials': 'O', 'LastName': 'Saldaña de Suman', 'Affiliation': 'Centro de Vacunación Internacional (Cevaxin), Panama City, Panama.'}, {'ForeName': 'Nathali', 'Initials': 'N', 'LastName': 'Montenegro', 'Affiliation': 'Centro de Vacunación Internacional (Cevaxin), Panama City, Panama.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'DeAntonio', 'Affiliation': 'Sistema Nacional de Investigación, Secretaría Nacional de Ciencia, Tecnología e Innovación, Panama City, Panama; Centro de Vacunación Internacional (Cevaxin), Panama City, Panama.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Mazara', 'Affiliation': 'Hospital Universitario Maternidad Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vargas', 'Affiliation': 'Hospital Universitario Maternidad Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Mendoza', 'Affiliation': 'Takeda Vaccines, Singapore, Singapore.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Rauscher', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'Brose', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Lefevre', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Suely', 'Initials': 'S', 'LastName': 'Tuboi', 'Affiliation': 'Takeda Pharmaceuticals, Rio de Janeiro, Brazil.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'Takeda Vaccines, Cambridge, MA, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30556-0']
3559,30098513,"Marital distress, depression, and a leaky gut: Translocation of bacterial endotoxin as a pathway to inflammation.","BACKGROUND


Marital distress and depression work in tandem to escalate risks for inflammation-related disorders. Translocation of bacterial endotoxin (lipopolysaccharide, LPS) from the gut microbiota to blood circulation stimulates systemic inflammatory responses.
METHODS


To investigate increased gut permeability (a ""leaky gut"") as one potential mechanistic pathway from marital distress and depression to heightened inflammation, this secondary analysis of a double-blind, randomized crossover study examined serial assessments of two endotoxin biomarkers, LPS-binding protein (LBP) and soluble CD14 (sCD14), as well as C-reactive protein (CRP), interleukin 6 (IL-6), and tumor necrosis factor alpha (TNF-α) during two separate 9.5 h visits. The 43 (N = 86) healthy married couples, ages 24-61 (mean = 38.22), discussed a marital disagreement during both visits; behavioral coding of these interactions provided data on hostile marital behaviors, a hallmark of marital distress. The Structured Diagnostic Interview for DSM-IV assessed participants' mood disorder history.
RESULTS


Participants with more hostile marital interactions had higher LBP than those who were less hostile. Additionally, the combination of more hostile marital interactions with a mood disorder history was associated with higher LBP/sCD14 ratios. Higher LBP and LBP/sCD14 were associated with greater CRP production; for example, only 21% of low LBP participants (lowest quartile) had average CRP across the day > 3, compared to 79% of those in the highest quartile. Higher sCD14 was associated with higher IL-6.
CONCLUSIONS


These bacterial LPS translocation data illustrate how a distressed marriage and a mood disorder history can promote a proinflammatory milieu through increased gut permeability, thus fueling inflammation-related disorders.",2018,Higher sCD14 was associated with higher,"['43 (N\u202f=\u202f86) healthy married couples, ages 24-61 (mean\u202f=\u202f38.22), discussed a marital disagreement during both visits; behavioral coding of these interactions provided data on hostile marital behaviors, a hallmark of marital distress']","['bacterial endotoxin (lipopolysaccharide, LPS']","['CRP production', 'Higher LBP and LBP/sCD14', 'LBP/sCD14 ratios', 'LPS-binding protein (LBP) and soluble CD14 (sCD14), as well as C-reactive protein (CRP), interleukin 6 (IL-6), and tumor necrosis factor alpha (TNF-α', 'gut permeability', 'average CRP']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]","[{'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}]","[{'cui': 'C0033268'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0065054', 'cui_str': 'LPS-binding protein'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]",86.0,0.0249957,Higher sCD14 was associated with higher,"[{'ForeName': 'Janice K', 'Initials': 'JK', 'LastName': 'Kiecolt-Glaser', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA; Department of Psychiatry and Behavioral Health, The Ohio State University College of Medicine, Columbus, OH, USA. Electronic address: Janice.Kiecolt-Glaser@osumc.edu.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Wilson', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Bailey', 'Affiliation': ""Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA; Department of Pediatrics, The Ohio State College of Medicine and Center for Microbial Pathogenesis, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Andridge', 'Affiliation': 'Division of Biostatistics, College of Public Health, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Center for Biostatistics, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Jaremka', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Fagundes', 'Affiliation': 'Department of Psychology, Rice University, Houston, TX, USA; Department of Behavioral Science, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Malarkey', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA; Department of Internal Medicine, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Laskowski', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Belury', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA; Department of Human Sciences, College of Education and Human Ecology, The Ohio State University, Columbus, OH, USA.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2018.08.007']
3560,31782643,A double-blind randomized controlled trial of total knee replacement using patient-specific cutting block instrumentation versus standard instrumentation,"Background


Patient-specific cutting blocks in total knee arthroplasty have been promoted to improve mechanical alignment, reduce alignment outliers and improve patient outcomes. The aim of this study was to compare the efficacy of patient-specific instrumentation (PSI) and conventional instrumentation (CI) in achieving neutral alignment and accurate component positioning in total knee arthroplasty.
Methods


We conducted a double-blinded randomized controlled trial in which patients were randomly assigned to treatment with either PSI or CI.
Results


Fifty-four patients were included in the study. No relevant improvement in coronal alignment was found between the PSI and CI groups with post-hoc power of 0.91. Tibial slope was found to be more accurately reproduced to the preoperative target of 3° with PSI than with CI (3.8°± 3.1° v. 7.7°± 3.6°, respectively, p < 0.001). There were no differences found in patient-reported outcome measures, surgical time or length of hospital stay.
Conclusion


Given the added cost of the PSI technique, its use is difficult to justify given the small improvement in only a single alignment parameter.
Clinical trial registration


Clinicaltrials.gov, no. NCT03416946",2019,No relevant improvement in coronal alignment was found between the PSI and CI groups with post-hoc power of 0.91.,"['total knee arthroplasty', 'Fifty-four patients were included in the study']","['PSI technique', 'patient-specific instrumentation (PSI) and conventional instrumentation (CI', 'PSI or CI', 'total knee replacement using patient-specific cutting block instrumentation versus standard instrumentation']","['coronal alignment', 'Tibial slope', 'surgical time or length of hospital stay']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1706489', 'cui_str': 'Psi'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",54.0,0.524409,No relevant improvement in coronal alignment was found between the PSI and CI groups with post-hoc power of 0.91.,"[{'ForeName': 'Thomas R.', 'Initials': 'TR', 'LastName': 'Turgeon', 'Affiliation': 'From the Department of Surgery, Section of Orthopaedics, Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); the Concordia Joint Replacement Group, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); and the Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Cameron).'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Cameron', 'Affiliation': 'From the Department of Surgery, Section of Orthopaedics, Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); the Concordia Joint Replacement Group, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); and the Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Cameron).'}, {'ForeName': 'Colin D.', 'Initials': 'CD', 'LastName': 'Burnell', 'Affiliation': 'From the Department of Surgery, Section of Orthopaedics, Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); the Concordia Joint Replacement Group, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); and the Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Cameron).'}, {'ForeName': 'David R.', 'Initials': 'DR', 'LastName': 'Hedden', 'Affiliation': 'From the Department of Surgery, Section of Orthopaedics, Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); the Concordia Joint Replacement Group, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); and the Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Cameron).'}, {'ForeName': 'Eric R.', 'Initials': 'ER', 'LastName': 'Bohm', 'Affiliation': 'From the Department of Surgery, Section of Orthopaedics, Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); the Concordia Joint Replacement Group, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); and the Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Cameron).'}]",Canadian journal of surgery. Journal canadien de chirurgie,['10.1503/cjs.018318']
3561,31080095,Diagnostic accuracy of whole-body MRI versus standard imaging pathways for metastatic disease in newly diagnosed colorectal cancer: the prospective Streamline C trial.,"BACKGROUND


Whole-body MRI (WB-MRI) could be an alternative to multimodality staging of colorectal cancer, but its diagnostic accuracy, effect on staging times, number of tests needed, cost, and effect on treatment decisions are unknown. We aimed to prospectively compare the diagnostic accuracy and efficiency of WB-MRI-based staging pathways with standard pathways in colorectal cancer.
METHODS


The Streamline C trial was a prospective, multicentre trial done in 16 hospitals in England. Eligible patients were 18 years or older, with newly diagnosed colorectal cancer. Exclusion criteria were severe systemic disease, pregnancy, contraindications to MRI, or polyp cancer. Patients underwent WB-MRI, the result of which was withheld until standard staging investigations were complete and the first treatment decision made. The multidisciplinary team recorded its treatment decision based on standard investigations, then on the WB-MRI staging pathway (WB-MRI plus additional tests generated), and finally on all tests. The primary outcome was difference in per-patient sensitivity for metastases between standard and WB-MRI staging pathways against a consensus reference standard at 12 months, in the per-protocol population. Secondary outcomes were difference in per-patient specificity for metastatic disease detection between standard and WB-MRI staging pathways, differences in treatment decisions, staging efficiency (time taken, test number, and costs), and per-organ sensitivity and specificity for metastases and per-patient agreement for local T and N stage. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN43958015, and is complete.
FINDINGS


Between March 26, 2013, and Aug 19, 2016, 1020 patients were screened for eligibility. 370 patients were recruited, 299 of whom completed the trial; 68 (23%) had metastasis at baseline. Pathway sensitivity was 67% (95% CI 56 to 78) for WB-MRI and 63% (51 to 74) for standard pathways, a difference in sensitivity of 4% (-5 to 13, p=0·51). No adverse events related to imaging were reported. Specificity did not differ between WB-MRI (95% [95% CI 92-97]) and standard pathways (93% [90-96], p=0·48). Agreement with the multidisciplinary team's final treatment decision was 96% for WB-MRI and 95% for the standard pathway. Time to complete staging was shorter for WB-MRI (median, 8 days [IQR 6-9]) than for the standard pathway (13 days [11-15]); a 5-day (3-7) difference. WB-MRI required fewer tests (median, one [95% CI 1 to 1]) than did standard pathways (two [2 to 2]), a difference of one (1 to 1). Mean per-patient staging costs were £216 (95% CI 211-221) for WB-MRI and £285 (260-310) for standard pathways.
INTERPRETATION


WB-MRI staging pathways have similar accuracy to standard pathways and reduce the number of tests needed, staging time, and cost.
FUNDING


UK National Institute for Health Research.",2019,"Time to complete staging was shorter for WB-MRI (median, 8 days [IQR 6-9]) than for the standard pathway (13 days [11-15]); a 5-day (3-7) difference.","['newly diagnosed colorectal cancer', '370 patients were recruited, 299 of whom completed the trial; 68 (23%) had metastasis at baseline', '16 hospitals in England', 'Eligible patients were 18 years or older, with newly diagnosed colorectal cancer', 'Between March 26, 2013, and Aug 19, 2016, 1020 patients were screened for eligibility']","['whole-body MRI versus standard imaging pathways', 'Whole-body MRI (WB-MRI']","['Specificity', 'Pathway sensitivity', 'per-patient sensitivity for metastases', 'Mean per-patient staging costs', 'severe systemic disease, pregnancy, contraindications to MRI, or polyp cancer', 'per-patient specificity for metastatic disease detection between standard and WB-MRI staging pathways, differences in treatment decisions, staging efficiency (time taken, test number, and costs), and per-organ sensitivity and specificity for metastases and per-patient agreement for local T and N stage']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C1142375', 'cui_str': 'Magnetic resonance imaging of whole body'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0442893', 'cui_str': 'Systemic illness (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0456532', 'cui_str': 'N category'}]",1020.0,0.205953,"Time to complete staging was shorter for WB-MRI (median, 8 days [IQR 6-9]) than for the standard pathway (13 days [11-15]); a 5-day (3-7) difference.","[{'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Taylor', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK. Electronic address: stuart.taylor@ucl.ac.uk.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Mallett', 'Affiliation': 'Institute of Applied Health Research, NIHR Birmingham Biomedical Research Centre, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Beare', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}, {'ForeName': 'Gauraang', 'Initials': 'G', 'LastName': 'Bhatnagar', 'Affiliation': 'Frimley Park Hospital, Frimley, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Blunt', 'Affiliation': 'Imaging Department, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Boavida', 'Affiliation': 'Department of Radiology, Homerton Hospital, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'UCL Cancer Institute, London, UK.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Clarke', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Duggan', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Ellis', 'Affiliation': 'Department of Radiology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Mount Vernon Centre for Cancer Treatment, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Goh', 'Affiliation': ""Department of Cancer Imaging, School of Biomedical Engineering and Imaging Sciences, King's College London, King's Health Partners, London, UK.""}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Groves', 'Affiliation': 'Institute of Nuclear Medicine, University College London, London, UK.'}, {'ForeName': 'Ayshea', 'Initials': 'A', 'LastName': 'Hameeduddin', 'Affiliation': 'Department of Radiology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Sam M', 'Initials': 'SM', 'LastName': 'Janes', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, University College London, London, UK; Department of Thoracic Medicine, University College London Hospitals, UK.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Johnston', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK.'}, {'ForeName': 'Dow-Mu', 'Initials': 'DM', 'LastName': 'Koh', 'Affiliation': 'Department of Radiology, Royal Marsden Hospital, Sutton, Surrey, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Miles', 'Affiliation': 'Department of Psychological Sciences, Birkbeck University of London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Department of Applied Health Research, University College London, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Morton', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Navani', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, University College London, London, UK; Department of Thoracic Medicine, University College London Hospitals, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Donohue"", 'Affiliation': 'Department of Gastroenterology, Lewisham Hospital, London, UK.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Oliver', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK.'}, {'ForeName': 'Anwar R', 'Initials': 'AR', 'LastName': 'Padhani', 'Affiliation': 'Paul Strickland Scanner Centre, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Pardoe', 'Affiliation': 'Department of Surgery, Homerton Hospital, London, UK.'}, {'ForeName': 'Uday', 'Initials': 'U', 'LastName': 'Patel', 'Affiliation': ""Intestinal Imaging Centre, St Mark's Hospital, LNWUH NHS Trust, Harrow, UK.""}, {'ForeName': 'Shonit', 'Initials': 'S', 'LastName': 'Punwani', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Quinn', 'Affiliation': 'Institute of Applied Health Research, NIHR Birmingham Biomedical Research Centre, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Hameed', 'Initials': 'H', 'LastName': 'Rafiee', 'Affiliation': 'Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Reczko', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}, {'ForeName': 'Andrea G', 'Initials': 'AG', 'LastName': 'Rockall', 'Affiliation': 'Department of Radiology, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK; Department of Cancer and Surgery, Imperial College London, London, UK.'}, {'ForeName': 'Khawaja', 'Initials': 'K', 'LastName': 'Shahabuddin', 'Affiliation': 'Department of Radiology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Harbir S', 'Initials': 'HS', 'LastName': 'Sidhu', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Teague', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Thaha', 'Affiliation': 'Blizard Institute, National Bowel Research Centre, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK; Department of Surgery, Barts Health NHS Trust, The Royal London Hospital, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Train', 'Affiliation': 'Department of Radiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'van Ree', 'Affiliation': 'Imaging Department, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Sanjaya', 'Initials': 'S', 'LastName': 'Wijeyekoon', 'Affiliation': 'Department of Surgery, Homerton Hospital, London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Halligan', 'Affiliation': 'Centre for Medical Imaging, University College London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30056-1']
3562,31739856,Long-Term Objective Adherence to Mandibular Advancement Device Therapy Versus Continuous Positive Airway Pressure in Patients With Moderate Obstructive Sleep Apnea.,"STUDY OBJECTIVES


Comparable health effects of mandibular advancement device (MAD) and continuous positive airway pressure (CPAP) therapy have been attributed to higher adherence with MAD compared with CPAP therapy. The objective of this study was to make a direct comparison of the objective adherence between MAD and CPAP in patients with moderate obstructive sleep apnea (OSA).
METHODS


Adherence was monitored for 12 months in 59 patients with moderate OSA (apnea-hypopnea index 15-30 events/h) as part of a randomized controlled trial. Objective adherence with MAD was assessed using the TheraMon microsensor. Objective adherence with CPAP was assessed using the built-in registration software with readout on SD card. Self-reported adherence with both therapies was assessed using a questionnaire.
RESULTS


Forty patients (68%) completed the study with the therapy to which they were randomly assigned. Median (interquartile range) objective adherence (h/night) in the 3rd month was 7.4 (5.2-8.2) for MAD and 6.8 (5.7-7.6) for CPAP (P = .41), compared to 6.9 (3.5-7.9) with MAD and 6.8 (5.2-7.6) with CPAP (P = .85) in the 12th month. There were no significant changes between the 3rd and 12th month for both MAD (P = .21) and CPAP (P = .46). Changes in adherence were not significantly different between MAD and CPAP (P = .51). Self-reported adherence was significantly higher with MAD than CPAP at all follow-ups. Self-reported adherence with CPAP was lower than objective CPAP adherence at the 6th and 12th month (P = .02).
CONCLUSIONS


Objective adherence with MAD and CPAP is comparable and consistent over time. Self-reported adherence is higher with MAD than with CPAP giving rise to interesting discrepancy between objective and self-reported adherence with CPAP.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Identifier: NCT01588275.",2019,There were no significant changes between the 3rd and 12th month for both MAD (P = .21) and CPAP (P = .46).,"['patients with moderate obstructive sleep apnea (OSA', 'Patients With Moderate Obstructive Sleep Apnea', '59 patients with moderate OSA (apnea-hypopnea index 15-30 events/h', 'Forty patients (68%) completed the study with the therapy to which they were randomly assigned']","['Mandibular Advancement Device Therapy Versus Continuous Positive Airway Pressure', 'mandibular advancement device (MAD) and continuous positive airway pressure (CPAP) therapy', 'CPAP therapy', 'MAD and CPAP']","['Objective adherence with MAD', 'Median (interquartile range) objective adherence', 'CPAP', 'Self-reported adherence', 'objective CPAP adherence', 'Objective adherence with CPAP', 'Changes in adherence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0376461', 'cui_str': 'Mandibular Advancement'}, {'cui': 'C1504335', 'cui_str': 'Device therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0671759', 'cui_str': 'MAD'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",40.0,0.0685954,There were no significant changes between the 3rd and 12th month for both MAD (P = .21) and CPAP (P = .46).,"[{'ForeName': 'Grietje E', 'Initials': 'GE', 'LastName': 'de Vries', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Aarnoud', 'Initials': 'A', 'LastName': 'Hoekema', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Johannes Q P J', 'Initials': 'JQPJ', 'LastName': 'Claessen', 'Affiliation': 'Department of Ear, Nose and Throat Surgery, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Stellingsma', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Stegenga', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Wijkstra', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8034']
3563,32044401,Long-term growth and bone development in children of HBV-infected mothers with and without fetal exposure to tenofovir disoproxil fumarate.,"BACKGROUND & AIMS


Tenofovir disoproxil fumarate (TDF) is the preferred treatment to prevent maternal transmission of HBV, owing to its efficacy and safety. However, data are lacking on the long-term safety outcomes in children following fetal exposure to TDF.
METHODS


Children participating in a prospective, multisite trial of maternal TDF treatment during late pregnancy were recruited for follow-up visits once a year. Growth parameters, serum biochemistry, HBV serology, and bone mineral density (BMD) by dual-energy x-ray absorptiometery scan were measured.
RESULTS


One hundred and twenty-eight children, 71 in the TDF and 57 in the control group, completed 255 follow-up visits at the age of 2 to 7 (median, 4.08) years. No differences in z-scores for weight-for-age (0.26 ± 0.90 vs. 0.22 ± 0.99, p = 0.481), z-scores for height-for-age (0.20 ± 1.02 vs. 0.25 ± 0.98, p = 0.812), and estimated glomerular filtration rate (169.12 ± 50.48 vs. 169.06 ± 34.46 ml/min/1.73m 2 , p = 0.479) were detected. After adjustment for age, sex and HBV status by multiple linear regression, children in the TDF and control group had comparable levels of serum calcium, phosphorus, bone-specific alkaline phosphatase, calcidiol and BMD of lumbar spines (0.55 ± 0.01 vs. 0.57 ± 0.01 g/cm 2 , p = 0.159) and left hip (0.56 ± 0.01 vs. 0.56 ± 0.01 g/cm 2 , p = 0.926).
CONCLUSIONS


Children of HBV-infected mothers who did or did not receive tenofovir disoproxil fumarate treatment during late pregnancy had comparable long-term growth, renal function, and bone development up to 6-7 years after delivery.
CLINICAL TRIAL NUMBER


NCT01312012 (ClinicalTrials.gov) LAY SUMMARY: Currently there are insufficient long-term safety data in children born to mothers who took antiviral agents during pregnancy to prevent mother-to-infant transmission of hepatitis B virus (HBV). In this study, we found that children of HBV-infected mothers who did or did not receive tenofovir disoproxil fumarate treatment during late pregnancy had comparable long-term growth, renal function, and bone development up to 6-7 years after delivery.",2020,"No differences in z-scores for weight-for-age (0.26 ± 0.90 vs. 0.22 ± 0.99, P = 0.481), z-scores for height-for-age (0.20 ± 1.02 vs. 0.25 ± 0.98, P = 0.812), and estimated glomerular filtration rate (169.12 ± 50.48 vs. 169.06 ± 34.46 ml/min/1.73mˆ2, P = 0.479) were detected.","['Children participating in a prospective, multisite trial of maternal TDF treatment during late pregnancy were recruited for follow-up visit once a year', 'children of HBV-infected mothers with and without fetal exposure to', 'children with fetal exposure to', 'One hundred and twenty-eight children, 71 in TDF and 57 in control group, completed 255 follow-up visits at the age of 2 to 7 (median, 4.08) years']","['tenofovir disoproxil fumarate', 'tenofovir disoproxil fumarate (TDF']","['levels of serum calcium', 'z-scores', 'bone specific alkaline phosphatase', 'glomerular filtration rate', 'BMD of lumbar spines', 'Growth parameters, serum biochemistry, HBV serology, and bone mineral density (BMD) by dual-energy x-ray absorptiometery scan', 'long-term growth, renal function, and bone development']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0036745', 'cui_str': 'Serology'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0441633'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0005939', 'cui_str': 'Bone Development'}]",128.0,0.0529129,"No differences in z-scores for weight-for-age (0.26 ± 0.90 vs. 0.22 ± 0.99, P = 0.481), z-scores for height-for-age (0.20 ± 1.02 vs. 0.25 ± 0.98, P = 0.812), and estimated glomerular filtration rate (169.12 ± 50.48 vs. 169.06 ± 34.46 ml/min/1.73mˆ2, P = 0.479) were detected.","[{'ForeName': 'Wan-Hsin', 'Initials': 'WH', 'LastName': 'Wen', 'Affiliation': 'Department of Pediatrics, Cardinal Tien Hospital, New Taipei City, Taiwan; School of Medicine, College of Medicine, Fu-Jen Catholic University, New Taipei City, Taiwan.'}, {'ForeName': 'Huey-Ling', 'Initials': 'HL', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan; Department and Graduate Institute of Medical Education and Bioethics, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Tiffany Ting-Fang', 'Initials': 'TT', 'LastName': 'Shih', 'Affiliation': 'Department of Radiology, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jia-Feng', 'Initials': 'JF', 'LastName': 'Wu', 'Affiliation': 'Department of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yen-Hsuan', 'Initials': 'YH', 'LastName': 'Ni', 'Affiliation': 'Department of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chien-Nan', 'Initials': 'CN', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Zhao', 'Affiliation': 'Department of Pediatrics, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, New Taipei City, Taiwan.'}, {'ForeName': 'Ming-Wei', 'Initials': 'MW', 'LastName': 'Lai', 'Affiliation': 'Division of Pediatric Gastroenterology, Department of Pediatrics; Liver Research Center, Chang Gung Memorial Hospital, Linkou Branch, Taiwan.'}, {'ForeName': 'Shu-Chi', 'Initials': 'SC', 'LastName': 'Mu', 'Affiliation': 'Department of Pediatrics, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yi-Ching', 'Initials': 'YC', 'LastName': 'Tung', 'Affiliation': 'Department of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hong-Yuan', 'Initials': 'HY', 'LastName': 'Hsu', 'Affiliation': 'Department of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan; Department and Graduate Institute of Medical Education and Bioethics, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Mei-Hwei', 'Initials': 'MH', 'LastName': 'Chang', 'Affiliation': 'Department of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan. Electronic address: changmh@ntu.edu.tw.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hepatology,['10.1016/j.jhep.2020.01.021']
3564,32154928,"NRG/RTOG 1122: A phase 2, double-blinded, placebo-controlled study of bevacizumab with and without trebananib in patients with recurrent glioblastoma or gliosarcoma.","BACKGROUND


Targeting vascular endothelial growth factor (VEGF) alone does not improve overall survival (OS) in recurrent glioblastoma (rGBM). The angiopoiein (Ang)-TIE2 system may play a role in tumor survival under VEGF inhibition. We conducted a phase 2, double-blinded, placebo-controlled trial of bevacizumab plus trebananib (a novel Fc fusion protein that sequesters Ang1/Ang2) over bevacizumab alone in rGBM.
METHODS


Patients ≥18 years of age with a Karnofsky performance status ≥70 and GBM or variants in first or second relapse were randomized to bevacizumab 10 mg/kg every 2 weeks plus trebananib 15 mg/kg every week or bevacizumab plus placebo. The primary endpoint was 6-month progression-free survival (PFS).
RESULTS


After an initial 6-patient lead-in cohort confirmed the safety of combining bevacizumab and trebananib, 115 eligible patients were randomized to the control (n = 58) or experimental treatment (n = 57). In the control arm, 6-month PFS was 41.1%, median survival time was 11.5 months (95% CI, 8.4-14.2 months), median PFS was 4.8 months (95% CI, 3.8-7.1 months), and radiographic response (RR) was 5.9%. In the experimental arm, 6-month PFS was 22.6%, median survival time was 7.5 months (95% CI, 6.8-10.1 months), median PFS was 4.2 months (95% CI, 3.7-5.6 months), and RR was 4.2%. The rate of severe toxicities was not significantly different between arms.
CONCLUSION


The combination of bevacizumab and trebananib was well tolerated but did not significantly improve 6-month PFS rate, PFS, or OS for patients with rGBM over bevacizumab alone. The shorter PFS in the experimental arm with a hazard ratio of 1.51 (P = .04) suggests that the addition of trebananib to bevacizumab is detrimental.",2020,"The combination of bevacizumab and trebananib was well tolerated but did not significantly improve 6-month PFS rate, PFS, or OS for patients with rGBM over bevacizumab alone.","['patients with recurrent glioblastoma or gliosarcoma', '115 eligible patients', 'Patients ≥18\xa0years of age with a Karnofsky performance status ≥70 and GBM or variants in first or second relapse']","['bevacizumab plus trebananib', 'bevacizumab 10\xa0mg/kg every 2\xa0weeks plus trebananib 15\xa0mg/kg every week or bevacizumab plus placebo', 'placebo', 'bevacizumab with and without trebananib', 'bevacizumab', 'bevacizumab and trebananib', 'angiopoiein']","['radiographic response (RR', '6-month PFS rate, PFS, or OS', 'overall survival (OS', 'rate of severe toxicities', 'shorter PFS', 'median survival time', '6-month progression-free survival (PFS', '6-month PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0206726', 'cui_str': 'Sarcomatous Glioma'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky Scale'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3660912', 'cui_str': 'trenananib'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",115.0,0.680496,"The combination of bevacizumab and trebananib was well tolerated but did not significantly improve 6-month PFS rate, PFS, or OS for patients with rGBM over bevacizumab alone.","[{'ForeName': 'Eudocia Q', 'Initials': 'EQ', 'LastName': 'Lee', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.""}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania.'}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.""}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Gerstner', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Reardon', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.""}, {'ForeName': 'Kenneth D', 'Initials': 'KD', 'LastName': 'Aldape', 'Affiliation': 'Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'deGroot', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Pan', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Raizer', 'Affiliation': 'Northwestern University, Evanston, Illinois.'}, {'ForeName': 'Lyndon J', 'Initials': 'LJ', 'LastName': 'Kim', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Chmura', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'H Ian', 'Initials': 'HI', 'LastName': 'Robins', 'Affiliation': 'University of Wisconsin Hospital and Clinics, Madison, Wisconsin.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Connelly', 'Affiliation': 'Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Battiste', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Villano', 'Affiliation': 'University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Wagle', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Merrell', 'Affiliation': 'North Shore University Health System, Evanston, Illinois.'}, {'ForeName': 'Merideth M', 'Initials': 'MM', 'LastName': 'Wendland', 'Affiliation': 'The US Oncology Network-Willamette Valley Cancer Institute, Eugene, Oregon.'}, {'ForeName': 'Minesh P', 'Initials': 'MP', 'LastName': 'Mehta', 'Affiliation': 'Baptist Hospital of Miami, Miami, Florida.'}]",Cancer,['10.1002/cncr.32811']
3565,32026827,Development and implementation of the physiotherapy-led exercise interventions for the treatment of rotator cuff disorders for the 'Getting it Right: Addressing Shoulder Pain' (GRASP) trial.,"OBJECTIVES


The Getting it Right: Addressing Shoulder Pain (GRASP) trial is a large-scale, multicentre, 2×2 factorial randomised controlled trial investigating clinical and cost-effectiveness of a progressive exercise programme versus best-practice advice, with or without corticosteroid injection, for treating people with rotator cuff disorders. Here we describe the development, implementation and details of the physiotherapy-led interventions.
METHODS


Medical Research Council guidance for developing complex interventions were used, taking into account clinical guidelines, expert and patient opinion, research evidence, current practice variation, and deliverability. A stakeholder meeting of 26 experts, clinicians, researchers, and patient representatives was used to design key components of the interventions. Stakeholders prioritised strengthening posterior rotator cuff muscles and using practical, easy-to-do exercises. The interventions were designed to be deliverable across the UK National Health Service.
RESULTS


Progressive exercise consists of up to six sessions with a physiotherapist over 16 weeks. The best-practice advice consists of one face-to-face session with a physiotherapist with substantially greater reliance on self-management. Both interventions include self-management advice, home-exercise instruction, and behaviour-change strategies to target exercise adherence. All participants receive a Participant Information Booklet. The best-practice advice intervention is a self-guided system of progressively challenging exercises, with demonstration videos and written materials. The progressive exercise intervention has a wider range of exercise options, and greater flexibility for tailoring, progression, supervised practice and feedback.
CONCLUSION


GRASP has recruited 708 participants and will provide high quality evidence to inform management of people with shoulder pain due to a rotator cuff disorder. Results are anticipated in 2020.
TRIAL REGISTRATION NUMBER


ISRCTN16539266; EudraCT number:2016-002991-28.",2020,"The progressive exercise intervention has a wider range of exercise options, and greater flexibility for tailoring, progression, supervised practice and feedback.
","['people with rotator cuff disorders', 'Right']","['progressive exercise intervention', 'progressive exercise programme versus best-practice advice, with or without corticosteroid injection', 'physiotherapy-led exercise interventions']",[],"[{'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",[],,0.0901959,"The progressive exercise intervention has a wider range of exercise options, and greater flexibility for tailoring, progression, supervised practice and feedback.
","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Keene', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Electronic address: david.keene@ndorms.ox.ac.uk.'}, {'ForeName': 'Hessam', 'Initials': 'H', 'LastName': 'Soutakbar', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hopewell', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Heine', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Jaggi', 'Affiliation': 'Royal National Orthopaedic Hospital NHS Trust, Stanmore, Middlesex, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Littlewood', 'Affiliation': 'Primary Care and Health Sciences, Keele University, Keele, UK.'}, {'ForeName': 'Zara', 'Initials': 'Z', 'LastName': 'Hansen', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Barker', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Willie', 'Initials': 'W', 'LastName': 'Hamilton', 'Affiliation': 'Institute of Health Research, University of Exeter, Exeter, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carr', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]",Physiotherapy,['10.1016/j.physio.2019.07.002']
3566,31434543,Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke.,"Background and Purpose- The amount of task-specific stepping practice provided during rehabilitation poststroke can influence locomotor recovery and reflects one aspect of exercise dose that can affect the efficacy of specific interventions. Emerging data suggest that markedly increasing the intensity and variability of stepping practice may also be critical, although such strategies are discouraged during traditional rehabilitation. The goal of this study was to determine the individual and combined contributions of intensity and variability of stepping practice to improving walking speed and distance in individuals poststroke. Methods- This phase 2, randomized, blinded assessor clinical trial was performed between May 2015 and November 2018. Individuals between 18 and 85 years old with hemiparesis poststroke of >6 months duration were recruited. Of the 152 individuals screened, 97 were randomly assigned to 1 of 3 training groups, with 90 completing >10 sessions. Interventions consisted of either high-intensity stepping (70%-80% heart rate reserve) of variable, difficult stepping tasks (high variable), high-intensity stepping performing only forward walking (high forward), and low-intensity stepping in variable contexts at 30% to 40% heart rate reserve (low variable). Participants received up to 30 sessions over 2 months, with testing at baseline, post-training, and a 3-month follow-up. Primary outcomes included walking speeds and timed distance, with secondary measures of dynamic balance, transfers, spatiotemporal kinematics, and metabolic measures. Results- All walking gains were significantly greater following either high-intensity group versus low-variable training (all P<0.001) with significant correlations with stepping amount and rate (r=0.48-60; P<0.01). Additional gains in spatiotemporal symmetry were observed with high-intensity training, and balance confidence increased only following high-variable training in individuals with severe impairments. Conclusions- High-intensity stepping training resulted in greater improvements in walking ability and gait symmetry than low-intensity training in individuals with chronic stroke, with potential greater improvements in balance confidence. Clinical Trial Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT02507466.",2019,"Additional gains in spatiotemporal symmetry were observed with high-intensity training, and balance confidence increased only following high-variable training in individuals with severe impairments.","['individuals with chronic stroke', '152 individuals screened, 97', 'individuals with severe impairments', 'May 2015 and November 2018', 'Individuals Poststroke', 'individuals poststroke', 'Individuals between 18 and 85 years old with hemiparesis poststroke of >6 months duration were recruited']","['Methods', 'Conclusions- High-intensity stepping training', ' and Purpose', 'high-intensity stepping (70%-80% heart rate reserve) of variable, difficult stepping tasks (high variable), high-intensity stepping performing only forward walking (high forward), and low-intensity stepping', 'low-intensity training']","['walking ability and gait symmetry', 'walking speeds and timed distance, with secondary measures of dynamic balance, transfers, spatiotemporal kinematics, and metabolic measures', 'balance confidence', 'All walking gains']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0457436', 'cui_str': 'Left hemiparesis (disorder)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}]","[{'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",97.0,0.0707049,"Additional gains in spatiotemporal symmetry were observed with high-intensity training, and balance confidence increased only following high-variable training in individuals with severe impairments.","[{'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, Indiana University School of Medicine (T.G.H., C.E.H., M.A.).'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Henderson', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, Indiana University School of Medicine (T.G.H., C.E.H., M.A.).'}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Plawecki', 'Affiliation': 'Rehabilitation Hospital of Indiana (T.G.H., C.E.H., A.P., E.L., J.L., M.H., M.A.).'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Lucas', 'Affiliation': 'Rehabilitation Hospital of Indiana (T.G.H., C.E.H., A.P., E.L., J.L., M.H., M.A.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lotter', 'Affiliation': 'Rehabilitation Hospital of Indiana (T.G.H., C.E.H., A.P., E.L., J.L., M.H., M.A.).'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Holthus', 'Affiliation': 'Rehabilitation Hospital of Indiana (T.G.H., C.E.H., A.P., E.L., J.L., M.H., M.A.).'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Brazg', 'Affiliation': 'Shirley Ryan Ability Lab, Chicago, IL (G.B., M.F., J.W., E.J.R.).'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Fahey', 'Affiliation': 'Shirley Ryan Ability Lab, Chicago, IL (G.B., M.F., J.W., E.J.R.).'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Woodward', 'Affiliation': 'Shirley Ryan Ability Lab, Chicago, IL (G.B., M.F., J.W., E.J.R.).'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Ardestani', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, Indiana University School of Medicine (T.G.H., C.E.H., M.A.).'}, {'ForeName': 'Elliot J', 'Initials': 'EJ', 'LastName': 'Roth', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University, Chicago, IL (T.G.H., E.J.R.).'}]",Stroke,['10.1161/STROKEAHA.119.026254']
3567,32109257,An adaptable implementation package targeting evidence-based indicators in primary care: A pragmatic cluster-randomised evaluation.,"BACKGROUND


In primary care, multiple priorities and system pressures make closing the gap between evidence and practice challenging. Most implementation studies focus on single conditions, limiting generalisability. We compared an adaptable implementation package against an implementation control and assessed effects on adherence to four different evidence-based quality indicators.
METHODS AND FINDINGS


We undertook two parallel, pragmatic cluster-randomised trials using balanced incomplete block designs in general practices in West Yorkshire, England. We used 'opt-out' recruitment, and we randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF) (Trial 2). Within trials, each arm acted as the implementation control comparison for the other targeted indicator. For example, practices assigned to the diabetes control package acted as the comparison for practices assigned to the risky prescribing package. The implementation package embedded behaviour change techniques within audit and feedback, educational outreach, and computerised support, with content tailored to each indicator. Respective patient-level primary endpoints at 11 months comprised the following: achievement of all recommended levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing. Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients. We stratified computer-generated randomisation by area, list size, and pre-intervention outcome achievement. In April 2015, we randomised 80 practices to Trial 1 (40 per arm) and 64 to Trial 2 (32 per arm). Practices and trial personnel were not blind to allocation. Two practices were lost to follow-up but provided some outcome data. We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at patient level (sex, age) and practice level (list size, locality, pre-intervention achievement against primary outcomes, total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness. The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67-0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89-1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96-1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75-1.09, p = 0.214). No statistically significant effects were observed in any secondary outcome except for reduced co-prescription of aspirin and clopidogrel without gastro-protection in patients aged 65 and over (adjusted OR 0.62; 97.5% CI 0.39-0.99; p = 0.021). Main study limitations concern our inability to make any inferences about the relative effects of individual intervention components, given the multifaceted nature of the implementation package, and that the composite endpoint for diabetes control may have been too challenging to achieve.
CONCLUSIONS


In this study, we observed that a multifaceted implementation package was clinically and cost-effective for targeting prescribing behaviours within the control of clinicians but not for more complex behaviours that also required patient engagement.
TRIAL REGISTRATION


The study is registered with the ISRCTN registry (ISRCTN91989345).",2020,"The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67-0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89-1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96-1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75-1.09, p = 0.214).","['general practices in West Yorkshire, England', 'Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients']",['randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF'],"['levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing', 'reduced co-prescription of aspirin and clopidogrel without gastro-protection', 'total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness']","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0454879', 'cui_str': 'West Yorkshire (geographic location)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",2.0,0.258025,"The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67-0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89-1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96-1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75-1.09, p = 0.214).","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Willis', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Collinson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Glidewell', 'Affiliation': 'Department of Health Sciences, Hull York Medical School, University of York, York, United Kingdom.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Holland', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Petty', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of Bradford, Bradford, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alderson', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Vargas-Palacios', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Carder', 'Affiliation': 'West Yorkshire Research and Development, NHS Bradford Districts CCG, Bradford, United Kingdom.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'West Yorkshire Research and Development, NHS Bradford Districts CCG, Bradford, United Kingdom.'}, {'ForeName': 'Robbie', 'Initials': 'R', 'LastName': 'Foy', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003045']
3568,31079087,Does soft tissue balancing using intraoperative pressure sensors improve clinical outcomes in total knee arthroplasty? A protocol of a multicentre randomised controlled trial.,"INTRODUCTION


Soft tissue imbalance is considered to be a major surgical cause of dissatisfaction following total knee arthroplasty (TKA). Surgeon-determined manual assessment of ligament tension has been shown to be a poor determinant of the true knee balance state. The recent introduction of intraoperative sensors, however, allows surgeons to precisely quantify knee compartment pressures and tibiofemoral kinematics, thereby optimising coronal and sagittal plane soft tissue balance. The primary hypothesis of this study is that achieving knee balance with use of sensors in TKA will improve patient-reported outcomes when compared with manual balancing.
METHODS AND ANALYSIS


A multicentred, randomised controlled trial will compare patient-reported outcomes in 222 patients undergoing TKA using sensor-guided balancing versus manual balancing. The sensor will be used in both arms for purposes of data collection; however, surgeons will be blinded to the pressure data in patients randomised to manual balancing. The primary outcome will be the change from baseline to 1 year postoperatively in the mean of the four subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS 4 ) that are most specific to TKA recovery: pain, symptoms, function and knee-related quality of life. Secondary outcomes will include the surgeon's capacity to determine knee balance, radiographic and functional measures and additional patient-reported outcomes. Normality of data will be assessed, and a Student's t-test and equivalent non-parametric tests will be used to compare differences in means among the two groups.
ETHICS AND DISSEMINATION


Ethics approval was obtained from South Eastern Sydney Local Health District, Approval (HREC/18/POWH/320). Results of the trial will be presented at orthopaedic surgical meetings and submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ACTRN#12618000817246.",2019,"The recent introduction of intraoperative sensors, however, allows surgeons to precisely quantify knee compartment pressures and tibiofemoral kinematics, thereby optimising coronal and sagittal plane soft tissue balance.","['Ethics approval was obtained from South Eastern Sydney Local Health District, Approval (HREC/18/POWH/320', 'total knee arthroplasty', '222 patients undergoing']","['TKA using sensor-guided balancing versus manual balancing', 'intraoperative pressure sensors']","[""surgeon's capacity to determine knee balance, radiographic and functional measures and additional patient-reported outcomes"", 'change from baseline to 1\u2009year postoperatively in the mean of the four subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS 4 ) that are most specific to TKA recovery: pain, symptoms, function and knee-related quality of life']","[{'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",222.0,0.223821,"The recent introduction of intraoperative sensors, however, allows surgeons to precisely quantify knee compartment pressures and tibiofemoral kinematics, thereby optimising coronal and sagittal plane soft tissue balance.","[{'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'MacDessi', 'Affiliation': 'Orthopaedic Surgery, St George Private Hospital, Kogarah, New South Wales, Australia.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Bhimani', 'Affiliation': 'Orthopaedic Surgery, Wollongong Private Hospital, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Alexander W R', 'Initials': 'AWR', 'LastName': 'Burns', 'Affiliation': 'Orthopaedic Surgery, Canberra Private Hospital, Deakin, Australian Capital Territory, Australia.'}, {'ForeName': 'Darren B', 'Initials': 'DB', 'LastName': 'Chen', 'Affiliation': 'Orthopaedic Surgery, St George Private Hospital, Kogarah, New South Wales, Australia.'}, {'ForeName': 'Anthony K L', 'Initials': 'AKL', 'LastName': 'Leong', 'Affiliation': 'Orthopaedic Surgery, Wollongong Private Hospital, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Molnar', 'Affiliation': 'Orthopaedic Surgery, St George Private Hospital, Kogarah, New South Wales, Australia.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Mulford', 'Affiliation': ""Orthopaedic Surgery, Calvary St Luke's Hospital, Launceston, Tasmania, Australia.""}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Walker', 'Affiliation': 'Orthopaedic Surgery, Sydney Southwest Private Hospital, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Harris', 'Affiliation': 'South West Sydney Clinical School, University of New South Wales, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Diwan', 'Affiliation': 'Orthopaedic Surgery, St George Private Hospital, Kogarah, New South Wales, Australia.'}, {'ForeName': 'Jil A', 'Initials': 'JA', 'LastName': 'Wood', 'Affiliation': 'Clinical Research, Sydney Knee Specialists, Kogarah, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-027812']
3569,32181499,Objective and subjective reduction of cellulite volume using a localized vibrational massage device in a 24-week randomized intra-individual single-blind regression study.,"Cellulite occurs in females and is a common condition of altered connective tissue matrix and increased adipogenicity with visible dimples and orange-peel appearance on the skins surface. Whilst advancements in methods continue to help our understanding, attempts to correct the appearance of cellulite topically have yielded limited success. Various kinds of non-invasive body contouring methods such as whole body vibration have been reported with demonstrable visible improvements in the cellulite condition. The aim of this study was to evaluate volume reduction and improvement of the visible appearance of cellulite as judged both objectively (AEVA-HE phase-shift 3-D fringe projection, macrophotography image grading) and subjectively (questionnaires) after application of a hand-held localized vibrational device over 24-weeks. The study was conducted on 40 healthy female volunteers who were instructed how to use the device on defined areas of cellulite of the outside and rear of the thighs (iliotibial band, and over biceps femoris region respectively). The initial 12 weeks of continuous massage application of the study were followed by a 12 week phase in which volunteers were split into 2 subgroups - one for assessment of regression effects and one for continuous application effects. AEVA (skin surface volume) measurements of cellulite-related dimples correlated with questionnaires and visual image evaluation scoring, in that in the iliotibial region cellulite was significantly reduced at 12 weeks. In the regression subgroup cellulite returned to initial values soon after cessation of treatment, whereas in the continuous application subgroup, cellulite remained diminished. The effect of this device to reduce cellulite as observed in this study proves that continuous use of vibrational massage is beneficial to mitigate visible signs of cellulite.",2020,The effect of this device to reduce cellulite as observed in this study is proves that continuous use of vibrational massage is beneficial to mitigate visible signs of cellulite.,"['40 healthy female volunteers who were instructed how to use the device on defined areas of cellulite of the outside and rear of the thighs (iliotibial band, and over biceps femoris region respectively']",['localized vibrational massage device'],['iliotibial region cellulite'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0424624', 'cui_str': 'Cellulite'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0424624', 'cui_str': 'Cellulite'}]",40.0,0.0183326,The effect of this device to reduce cellulite as observed in this study is proves that continuous use of vibrational massage is beneficial to mitigate visible signs of cellulite.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sadowski', 'Affiliation': 'proDERM Institute of Applied Dermatological Research GmbH, 22869, Schenefeld-Hamburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bielfeldt', 'Affiliation': 'proDERM Institute of Applied Dermatological Research GmbH, 22869, Schenefeld-Hamburg, Germany.'}, {'ForeName': 'K-P', 'Initials': 'KP', 'LastName': 'Wilhelm', 'Affiliation': 'proDERM Institute of Applied Dermatological Research GmbH, 22869, Schenefeld-Hamburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sukopp', 'Affiliation': 'Beurer GmbH, 89077, Ulm-Donau, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gordon', 'Affiliation': 'CIT Research Institute, Ahornstr. 31, 70597, Stuttgart, Germany.'}]",International journal of cosmetic science,['10.1111/ics.12613']
3570,31270506,Investigation of the role of typhoid toxin in acute typhoid fever in a human challenge model.,"Salmonella Typhi is a human host-restricted pathogen that is responsible for typhoid fever in approximately 10.9 million people annually 1 . The typhoid toxin is postulated to have a central role in disease pathogenesis, the establishment of chronic infection and human host restriction 2-6 . However, its precise role in typhoid disease in humans is not fully defined. We studied the role of typhoid toxin in acute infection using a randomized, double-blind S. Typhi human challenge model 7 . Forty healthy volunteers were randomized (1:1) to oral challenge with 10 4  colony-forming units of wild-type or an isogenic typhoid toxin deletion mutant (TN) of S. Typhi. We observed no significant difference in the rate of typhoid infection (fever ≥38 °C for ≥12 h and/or S. Typhi bacteremia) between participants challenged with wild-type or TN S. Typhi (15 out of 21 (71%) versus 15 out of 19 (79%); P = 0.58). The duration of bacteremia was significantly longer in participants challenged with the TN strain compared with wild-type (47.6 hours (28.9-97.0) versus 30.3(3.6-49.4); P ≤ 0.001). The clinical syndrome was otherwise indistinguishable between wild-type and TN groups. These data suggest that the typhoid toxin is not required for infection and the development of early typhoid fever symptoms within the context of a human challenge model. Further clinical data are required to assess the role of typhoid toxin in severe disease or the establishment of bacterial carriage.",2019,The duration of bacteremia was significantly longer in participants challenged with the TN strain compared with wild-type (47.6 hours (28.9-97.0) versus 30.3(3.6-49.4); P ≤ 0.001).,['Forty healthy volunteers'],"['oral challenge with 10 4  colony-forming units of wild-type or an isogenic typhoid toxin deletion mutant (TN) of S. Typhi', 'typhoid toxin']","['rate of typhoid infection', 'duration of bacteremia']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}]","[{'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}]",40.0,0.136122,The duration of bacteremia was significantly longer in participants challenged with the TN strain compared with wild-type (47.6 hours (28.9-97.0) versus 30.3(3.6-49.4); P ≤ 0.001).,"[{'ForeName': 'Malick M', 'Initials': 'MM', 'LastName': 'Gibani', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK. malick.gibani@paediatrics.ox.ac.uk.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Barton', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Meek', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Camara', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Ushma', 'Initials': 'U', 'LastName': 'Galal', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Heinz', 'Affiliation': 'Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, UK.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Rosenberg-Hasson', 'Affiliation': 'Human Immune Monitoring Center, Institute for Immunity, Transplantation and Infection, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Gerlinde', 'Initials': 'G', 'LastName': 'Obermoser', 'Affiliation': 'Human Immune Monitoring Center, Institute for Immunity, Transplantation and Infection, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Black', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Thomaides-Brears', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Darlow', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dold', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Silva-Reyes', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Blackwell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lara-Tejero', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Xuyao', 'Initials': 'X', 'LastName': 'Jiao', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Stack', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Christoph J', 'Initials': 'CJ', 'LastName': 'Blohmke', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Dougan', 'Affiliation': 'Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, UK.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Galán', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}]",Nature medicine,['10.1038/s41591-019-0505-4']
3571,31893580,Lipoprotein(a) Reduction in Persons with Cardiovascular Disease.,"BACKGROUND


Lipoprotein(a) levels are genetically determined and, when elevated, are a risk factor for cardiovascular disease and aortic stenosis. There are no approved pharmacologic therapies to lower lipoprotein(a) levels.
METHODS


We conducted a randomized, double-blind, placebo-controlled, dose-ranging trial involving 286 patients with established cardiovascular disease and screening lipoprotein(a) levels of at least 60 mg per deciliter (150 nmol per liter). Patients received the hepatocyte-directed antisense oligonucleotide AKCEA-APO(a)-L Rx , referred to here as APO(a)-L Rx  (20, 40, or 60 mg every 4 weeks; 20 mg every 2 weeks; or 20 mg every week), or saline placebo subcutaneously for 6 to 12 months. The lipoprotein(a) level was measured with an isoform-independent assay. The primary end point was the percent change in lipoprotein(a) level from baseline to month 6 of exposure (week 25 in the groups that received monthly doses and week 27 in the groups that received more frequent doses).
RESULTS


The median baseline lipoprotein(a) levels in the six groups ranged from 204.5 to 246.6 nmol per liter. Administration of APO(a)-L Rx  resulted in dose-dependent decreases in lipoprotein(a) levels, with mean percent decreases of 35% at a dose of 20 mg every 4 weeks, 56% at 40 mg every 4 weeks, 58% at 20 mg every 2 weeks, 72% at 60 mg every 4 weeks, and 80% at 20 mg every week, as compared with 6% with placebo (P values for the comparison with placebo ranged from 0.003 to <0.001). There were no significant differences between any APO(a)-L Rx  dose and placebo with respect to platelet counts, liver and renal measures, or influenza-like symptoms. The most common adverse events were injection-site reactions.
CONCLUSIONS


APO(a)-L Rx  reduced lipoprotein(a) levels in a dose-dependent manner in patients who had elevated lipoprotein(a) levels and established cardiovascular disease. (Funded by Akcea Therapeutics; ClinicalTrials.gov number, NCT03070782.).",2020,Rx  reduced lipoprotein(a) levels in a dose-dependent manner in patients who had elevated lipoprotein(a) levels and established cardiovascular disease.,"['286 patients with established cardiovascular disease and screening lipoprotein(a) levels of at least 60 mg per deciliter (150 nmol per liter', 'Persons with Cardiovascular Disease', 'patients who had elevated lipoprotein(a) levels and established cardiovascular disease']","['APO(a)-L', 'placebo', 'APO(a)-L Rx', 'saline placebo', 'hepatocyte-directed antisense oligonucleotide AKCEA-APO(a)-L Rx , referred to here as APO(a)-L Rx']","['median baseline lipoprotein(a) levels', 'lipoprotein(a) level', 'percent change in lipoprotein(a) level', 'platelet counts, liver and renal measures, or influenza-like symptoms', 'lipoprotein(a) levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439191', 'cui_str': 'nmol'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0227525', 'cui_str': 'Hepatic Cells'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0079925', 'cui_str': 'Anti-Sense Oligonucleotides'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms (finding)'}]",286.0,0.410757,Rx  reduced lipoprotein(a) levels in a dose-dependent manner in patients who had elevated lipoprotein(a) levels and established cardiovascular disease.,"[{'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Karwatowska-Prokopczuk', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Gouni-Berthold', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Seth J', 'Initials': 'SJ', 'LastName': 'Baum', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Steinhagen-Thiessen', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Shapiro', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Erik S', 'Initials': 'ES', 'LastName': 'Stroes', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Moriarty', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Børge G', 'Initials': 'BG', 'LastName': 'Nordestgaard', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Guerriero', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Viney', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': ""O'Dea"", 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Witztum', 'Affiliation': 'From the Divisions of Cardiovascular Medicine (S.T.) and Endocrinology and Metabolism (J.L.W.), University of California, San Diego, La Jolla, and Ionis Pharmaceuticals, Carlsbad (S.T., S.X., N.J.V.) - both in California; Akcea Therapeutics, Boston (E.K.-P., J.G., L.O.); Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany (I.G.-B.); Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.); Excel Medical Clinical Trials, Boca Raton, FL (S.J.B.); the Department of Endocrinology and Metabolism, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität Berlin, Berlin Institute of Health, Berlin (E.S.-T.), and the Division of Geriatrics, University Medicine Greifswald, Greifswald (E.S.-T.) - both in Germany; the Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.D.S.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.S.); the Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City (P.M.M.); and the Department of Clinical Biochemistry and the Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev (B.G.N.), and the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen (B.G.N.) - all in Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1905239']
3572,32159711,Effectiveness of an internet-based self-guided program to treat depression in a sample of Brazilian users: a study protocol.,"Although psychological treatments for depressive disorders are available, they are often expensive or inaccessible for many. Web-based interventions that require minimal or no contact with therapists have been shown effective. To the best of our knowledge, no study using this treatment format has been conducted in Brazil. The Deprexis program was designed using empirically established principles of cognitive-behavioral therapy to reduce depressive symptoms. The objective of this study was to evaluate the effectiveness of Deprexis in Brazil. This randomized controlled trial will include 128 Brazilians with clinically significant depression symptoms or who have been diagnosed with depressive disorder (major depressive disorder or dysthymia), recruited over the internet (Brazilian forums, social networks, or e-mail lists). Individuals with other psychiatric diagnoses that require significant attention (e.g., bipolar disorder, psychosis) will not be included in the trial. Participants will be randomly assigned to 1) treatment as usual plus immediate access to Deprexis or 2) treatment as usual plus delayed access to Deprexis (after 8 weeks). Participants will be able to obtain other treatment types in addition to the online intervention. If found effective, this web-based intervention would increase the evidence-based care options for depression treatment in Brazil.",2020,Participants will be randomly assigned to 1) treatment as usual plus immediate access to Deprexis or 2) treatment as usual plus delayed access to Deprexis (after 8 weeks).,"['128 Brazilians with clinically significant depression symptoms or who have been diagnosed with depressive disorder (major depressive disorder or dysthymia), recruited over the internet (Brazilian forums, social networks, or e-mail lists', 'Individuals with other psychiatric diagnoses', 'a sample of Brazilian users']","['usual plus immediate access to Deprexis or 2) treatment as usual plus delayed access to Deprexis', 'internet-based self-guided program']",[],"[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0013415', 'cui_str': 'Dysthymic Disorder'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0376338', 'cui_str': 'Diagnosis, Psychiatric'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],128.0,0.130412,Participants will be randomly assigned to 1) treatment as usual plus immediate access to Deprexis or 2) treatment as usual plus delayed access to Deprexis (after 8 weeks).,"[{'ForeName': 'Rodrigo T', 'Initials': 'RT', 'LastName': 'Lopes', 'Affiliation': 'Universidade Católica de Petrópolis, RJ, Brazil.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Gaia Group, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Svacina', 'Affiliation': 'Universidade Católica de Petrópolis, RJ, Brazil.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0582']
3573,31542128,Efficacy of an m-Health Physical Activity and Sleep Health Intervention for Adults: A Randomized Waitlist-Controlled Trial.,"INTRODUCTION


Interventions that improve both physical activity and sleep quality may be more effective in improving overall health. The purpose of the Synergy Study is to test the efficacy of a mobile health combined behavior intervention targeting physical activity and sleep quality.
STUDY DESIGN


Randomized, waitlist-controlled trial.
SETTING/PARTICIPANTS


This study had an app-based delivery mode, Australia-wide. The participants were 160 adults who reported insufficient physical activity and poor sleep quality in an eligibility survey.
INTERVENTION


The intervention was a mobile app providing educational resources, goal setting, self-monitoring, and feedback strategies. It included 12 weeks of personalized support including weekly reports, tool sheets, and prompts.
MAIN OUTCOME MEASURES


Outcomes were assessed at baseline, 3 months (primary), and 6 months (secondary endpoint). Self-reported minutes of moderate-to-vigorous intensity physical activity and sleep quality were co-primary outcomes. Resistance training; sitting time; sleep hygiene; sleep timing variability; insomnia severity; daytime sleepiness; quality of life; and depression, anxiety, and stress symptoms were secondary outcomes. Data were collected between June 2017 and February 2018 and analyzed in August 2018.
RESULTS


At 3 months, between-group differences in moderate-to-vigorous intensity physical activity were not statistically significant (p=0.139). Significantly more participants in the intervention group engaged in ≥2 days/week (p=0.004) of resistance training. The intervention group reported better overall sleep quality (p=0.009), subjective sleep quality (p=0.017), sleep onset latency (p=0.013), waketime variability (p=0.018), sleep hygiene (p=0.027), insomnia severity (p=0.002), and lower stress symptoms (p=0.032) relative to waitlist controls. At 6 months, group differences were maintained for sleep hygiene (p=0.048), insomnia severity (p=0.002), and stress symptoms (p=0.006). Differences were observed for bedtime variability (p=0.023), sleepiness (p<0.001), daytime dysfunction (p=0.039), and anxiety symptoms (p=0.003) at 6 months, but not 3 months.
CONCLUSIONS


This remotely delivered intervention did not produce statistically significant between-group differences in minutes of moderate-to-vigorous intensity physical activity. Significant short-term differences in resistance training and short- and medium-term differences in sleep health in favor of the intervention were observed.
TRIAL REGISTRATION


This study is registered at anzctr.org.au ACTRN12617000376347.",2019,This remotely delivered intervention did not produce statistically significant between-group differences in minutes of moderate-to-vigorous intensity physical activity.,"['participants were 160 adults who reported insufficient physical activity and poor sleep quality in an eligibility survey', 'Adults', 'Data were collected between June 2017 and February 2018 and analyzed in August 2018']","['mobile health combined behavior intervention', 'm-Health Physical Activity and Sleep Health Intervention']","['sleep onset latency', 'lower stress symptoms', 'sleep hygiene', 'stress symptoms', 'anxiety symptoms', 'sleepiness (p<0.001), daytime dysfunction', 'moderate-to-vigorous intensity physical activity', 'subjective sleep quality', 'bedtime variability', 'sleep health', 'overall sleep quality', 'insomnia severity', 'depression, anxiety, and stress symptoms', 'waketime variability']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",160.0,0.0733544,This remotely delivered intervention did not produce statistically significant between-group differences in minutes of moderate-to-vigorous intensity physical activity.,"[{'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Murawski', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia; Faculty of Health and Medicine, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Plotnikoff', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia; Faculty of Education and Arts, School of Education, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Anna T', 'Initials': 'AT', 'LastName': 'Rayward', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia; Faculty of Health and Medicine, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Faculty of Health and Medicine, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia; Faculty of Health, Center for Clinical Epidemiology and Biostatistics, Callaghan, New South Wales, Australia; Clinical Research Design and Statistics Unit, Hunter Medical Research Institute, New Lambton, New South Wales, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Physical Activity Research Group, Appleton Institute, Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Brown', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, University of Queensland, St. Lucia, Queensland, Australia.'}, {'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia; Faculty of Health and Medicine, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia. Electronic address: mitch.duncan@newcastle.edu.au.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.05.009']
3574,31227528,Evaluating probiotics for the prevention of ventilator-associated pneumonia: a randomised placebo-controlled multicentre trial protocol and statistical analysis plan for PROSPECT.,"INTRODUCTION


Ventilator-associated pneumonia (VAP) is the most common healthcare-associated infection in critically ill patients. Prior studies suggest that probiotics may reduce VAP and other infections in critically ill patients; however, most previous randomised trials were small, single centre studies. The Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT) aims to determine the impact of the probiotic  Lactobacillus rhamnosus  GG on VAP and other clinically important outcomes in critically ill adults.
METHODS


PROSPECT is a multicentre, concealed, randomised, stratified, blinded, controlled trial in patients ≥18 years old, anticipated to be mechanically ventilated ≥72 hours, in intensive care units (ICUs) in Canada, the USA and Saudi Arabia. Patients receive either 1×10 10  colony forming units of  L. rhamnosus  GG twice daily or an identical appearing placebo. Those at increased risk of probiotic infection are excluded. The primary outcome is VAP. Secondary outcomes are other ICU-acquired infections including  Clostridioides difficile  infection, diarrhoea (including antibiotic-associated diarrhoea), antimicrobial use, ICU and hospital length of stay and mortality. The planned sample size of 2650 patients is based on an estimated 15% VAP rate and will provide 80% power to detect a 25% relative risk reduction.
ETHICS AND DISSEMINATION


This protocol and statistical analysis plan outlines the methodology, primary and secondary analyses, sensitivity analyses and subgroup analyses. PROSPECT is approved by Health Canada (#9427-M1133-45C), the research ethics boards of all participating hospitals and Public Health Ontario. Results will be disseminated via academic channels (peer reviewed journal publications, professional healthcare fora including international conferences) and conventional and social media. The results of PROSPECT will inform practice guidelines worldwide.
TRIALREGISTRATION NUMBER


NCT02462590; Pre-results.",2019,"Secondary outcomes are other ICU-acquired infections including  Clostridioides difficile  infection, diarrhoea (including antibiotic-associated diarrhoea), antimicrobial use, ICU and hospital length of stay and mortality.","['ventilator-associated pneumonia', 'critically ill patients', 'patients ≥18 years old, anticipated to be mechanically ventilated ≥72\u2009hours, in intensive care units (ICUs) in Canada, the USA and Saudi Arabia', 'critically ill adults']","['1×10 10 \u2009colony forming units of  L. rhamnosus  GG twice daily or an identical appearing placebo', 'placebo', 'probiotic  Lactobacillus rhamnosus  GG']","['VAP', 'ICU-acquired infections including  Clostridioides difficile  infection, diarrhoea (including antibiotic-associated diarrhoea), antimicrobial use, ICU and hospital length of stay and mortality']","[{'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0036243', 'cui_str': 'Kingdom of Saudi Arabia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",2650.0,0.536264,"Secondary outcomes are other ICU-acquired infections including  Clostridioides difficile  infection, diarrhoea (including antibiotic-associated diarrhoea), antimicrobial use, ICU and hospital length of stay and mortality.","[{'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Johnstone', 'Affiliation': 'Public Health Ontario, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Meade', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': ""Surgery/Critical Care Medicine, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Lauzier', 'Affiliation': 'Critical Care, CHU de Quebec-Universite Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'Erick Huaileigh', 'Initials': 'EH', 'LastName': 'Duan', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Zytaruk', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daphnee', 'Initials': 'D', 'LastName': 'Lamarche', 'Affiliation': 'Department of Biochemistry and Biomedical Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Surette', 'Affiliation': 'Department of Biochemistry and Biomedical Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cook', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-025228']
3575,31812956,Interaction of Blood Pressure Lowering and Alteplase Dose in Acute Ischemic Stroke: Results of the Enhanced Control of Hypertension and Thrombolysis Stroke Study.,"OBJECTIVE


To determine the extent to which the effects of intensive blood pressure (BP) lowering are modified by doses of alteplase in thrombolysis-eligible acute ischemic stroke (AIS) patients.
METHODS


Prespecified analyses of the Enhanced Control of Hypertension and Thrombolysis Stroke Study for patients enrolled in both arms: (i) low-dose (0.6 mg/kg body weight) or standard-dose (0.9 mg/kg) alteplase and (ii) intensive (target systolic BP [SBP] 130-140 mm Hg) or guideline-recommended (target SBP <180 mm Hg) BP management. The primary outcome was functional recovery, measured by a shift in scores on modified Rankin scale at 90 days. The safety outcome was any intracranial hemorrhage (ICH).
RESULTS


There were 925 participants (mean age 67 years, 39% female, 77% Asian) randomized to both arms: 242 randomly assigned to guideline/standard-dose (GS); 234 to guideline/low-dose (GL); 227 to intensive/standard-dose (IS); and 222 to intensive/low-dose (IL). Overall, average SBP levels within 24 h were lower in the low-dose compared to standard-dose alteplase group (146 and 144 vs. 151 and 150 mm Hg, for GS and GL vs. IS and IL, respectively, p < 0.0001). There was no heterogeneity of the effects of BP lowering (intensive vs. guideline) on functional recovery between standard-dose (OR 0.81, 95% CI 0.59-1.12) and low-dose alteplase (1.06, 0.77-1.47; p = 0.25 for interaction). Similar results were observed for ICH (p = 0.50 for interaction).
CONCLUSIONS


In thrombolysis-treated patients with predominantly mild-to-moderate severity AIS, intensive BP lowering neither improve functional recovery, either with low- or standard-dose intravenous alteplase, nor beneficially interact with low-dose alteplase in reducing ICH.
TRIAL REGISTRATION


The trial is registered with ClinicalTrials.gov (NCT01422616).",2019,"Overall, average SBP levels within 24 h were lower in the low-dose compared to standard-dose alteplase group (146 and 144 vs. 151 and 150 mm Hg, for GS and GL vs. IS and IL, respectively, p < 0.0001).","['925 participants (mean age 67 years, 39% female, 77% Asian) randomized to both arms: 242 randomly assigned to', 'patients enrolled in both arms: (i) low-dose (0.6 mg/kg body weight) or standard-dose (0.9 mg/kg', 'Acute Ischemic Stroke', 'thrombolysis-eligible acute ischemic stroke (AIS) patients']","['guideline/standard-dose (GS); 234 to guideline/low-dose (GL); 227 to intensive/standard-dose (IS); and 222 to intensive/low-dose (IL', 'alteplase', 'alteplase and (ii) intensive (target systolic BP [SBP] 130-140 mm Hg) or guideline-recommended (target SBP <180 mm Hg', 'Blood Pressure Lowering and Alteplase Dose', 'intensive blood pressure (BP']","['functional recovery, measured by a shift in scores on modified Rankin scale', 'average SBP levels', 'intracranial hemorrhage (ICH', 'BP lowering', 'functional recovery']","[{'cui': 'C4517904', 'cui_str': 'Nine hundred and twenty-five'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms (body structure)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0560741', 'cui_str': 'milligram/kg body weight'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}]",925.0,0.290739,"Overall, average SBP levels within 24 h were lower in the low-dose compared to standard-dose alteplase group (146 and 144 vs. 151 and 150 mm Hg, for GS and GL vs. IS and IL, respectively, p < 0.0001).","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'The George Institute China at Peking University Health Science Centre, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Chengdu Medical College, Chengdu, China.'}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'The George Institute China at Peking University Health Science Centre, Beijing, China.'}, {'ForeName': 'Tom J', 'Initials': 'TJ', 'LastName': 'Moullaali', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Else Charlotte', 'Initials': 'EC', 'LastName': 'Sandset', 'Affiliation': 'Department of Neurology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Sydney Medical School, Westmead Hospital, Discipline of Medicine, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Thompson G', 'Initials': 'TG', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Jatinder S', 'Initials': 'JS', 'LastName': 'Minhas', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Public Health, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jong S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Division of Neurology, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Ji-Guang', 'Initials': 'JG', 'LastName': 'Wang', 'Affiliation': 'Shanghai Institute for Hypertension, Rui Jin Hospital and Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Octávio', 'Initials': 'O', 'LastName': 'Pontes-Neto', 'Affiliation': 'Stroke Service, Division of Neurology, Department of Neuroscience and Behavioral Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': 'Departamento de Neurologia y Psiquiateria, Clinica Alemana de Santiago, Facultad de Medicina, Clinica Alemana Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': 'Departamento de Neurologia y Psiquiateria, Clinica Alemana de Santiago, Facultad de Medicina, Clinica Alemana Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Tsong-Hai', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Levi', 'Affiliation': 'University of Newcastle, School of Medicine and Public Health, University Drive, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Sheila O', 'Initials': 'SO', 'LastName': 'Martins', 'Affiliation': 'Stroke Division of Neurology Service, Hospital de Clinicas de Porto Alegre, University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Nguyen H', 'Initials': 'NH', 'LastName': 'Thang', 'Affiliation': 'Department of Cerebrovascular Disease, The People 115 Hospital, Ho Chi Min City, Vietnam.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia, canderson@george.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000504745']
3576,31712342,Sedation AND Weaning In Children (SANDWICH): protocol for a cluster randomised stepped wedge trial.,"INTRODUCTION


Weaning from ventilation is a complex process involving several stages that include recognition of patient readiness to begin the weaning process, steps to reduce ventilation while optimising sedation in order not to induce distress and removing the endotracheal tube. Delay at any stage can prolong the duration of mechanical ventilation. We developed a multicomponent intervention targeted at helping clinicians to safely expedite this process and minimise the harms associated with unnecessary mechanical ventilation.
METHODS AND ANALYSIS


This is a 20-month cluster randomised stepped wedge clinical and cost-effectiveness trial with an internal pilot and a process evaluation. It is being conducted in 18 paediatric intensive care units in the UK to evaluate a protocol-based intervention for reducing the duration of invasive mechanical ventilation. Following an initial 8-week baseline data collection period in all sites, one site will be randomly chosen to transition to the intervention every 4 weeks and will start an 8-week training period after which it will continue the intervention for the remaining duration of the study. We aim to recruit approximately 10 000 patients. The primary analysis will compare data from before the training (control) with that from after the training (intervention) in each site. Full details of the analyses will be in the statistical analysis plan.
ETHICS AND DISSEMINATION


This protocol was reviewed and approved by NRES Committee East Midlands-Nottingham 1 Research Ethics Committee (reference: 17/EM/0301). All sites started patient recruitment on 5 February 2018 before randomisation in April 2018. Results will be disseminated in 2020. The results will be presented at national and international conferences and published in peer-reviewed medical journals.
TRIAL REGISTRATION NUMBER


ISRCTN16998143.",2019,"We developed a multicomponent intervention targeted at helping clinicians to safely expedite this process and minimise the harms associated with unnecessary mechanical ventilation.
","['recruit approximately 10\u2009000 patients', '18 paediatric intensive care units in the UK']",['Sedation AND Weaning'],['duration of mechanical ventilation'],"[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]",18.0,0.137875,"We developed a multicomponent intervention targeted at helping clinicians to safely expedite this process and minimise the harms associated with unnecessary mechanical ventilation.
","[{'ForeName': 'Bronagh', 'Initials': 'B', 'LastName': 'Blackwood', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK b.blackwood@qub.ac.uk MargaretX.Murray@nictu.hscni.net.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Agus', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Roisin', 'Initials': 'R', 'LastName': 'Boyle', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""Centre for Public Health, Institute of Clinical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Public Health, Epidemiology and Biostatistics, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Macrae', 'Affiliation': 'Paediatric Intensive Care Unit, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Daniel Francis', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Clíona', 'Initials': 'C', 'LastName': 'McDowell', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McIlmurray', 'Affiliation': ""Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Morris', 'Affiliation': ""Paediatric Intensive Care Unit, Birmingham Women's and Children's Hospital, Birmingham, UK.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK b.blackwood@qub.ac.uk MargaretX.Murray@nictu.hscni.net.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Parslow', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Peters', 'Affiliation': 'Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Trust, London, UK.'}, {'ForeName': 'Lyvonne N', 'Initials': 'LN', 'LastName': 'Tume', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': ""MRC Centre for Inflammation Research, The Queen's Medical Research Institute, The University of Edinburgh, Edinburgh, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-031630']
3577,31492475,Text message reminders to improve infant immunization in Guatemala: A randomized clinical trial.,"OBJECTIVE


Millions of infants worldwide remain under-immunized and at risk for unnecessary morbidity and mortality. Text messaging may offer a low-cost solution. We aimed to evaluate text message reminders to improve infant immunization in Guatemala.
METHODS


A randomized clinical trial was conducted at four public health clinics in rural and urban Guatemala. Infants ages six weeks to six months presenting for the first visit of the primary immunization series were randomly and equally allocated to an intervention or usual care group. Intervention participants were sent three text reminders before the second and third vaccine visits. The main outcome was timeliness of the second and third visits of the primary immunization series.
RESULTS


Of 1088 families approached for enrollment between March to November 2016, 871 were eligible and 720 (82.7%) participated; only 54 families did not own a cell phone. Due to country-wide vaccine shortages, visit completion was used as a proxy for overall immunization coverage. In intention to treat analysis, both intervention and usual care groups had high rates of visit completion, but intervention participants presented on the scheduled date more often (151 [42.2%] of 358 intervention vs. 111 [30.7%] of 362 usual care participants for visit 2, p = 0.001, and 112 [34.0%] of 329 intervention vs. 90 [27.0%] of 333 usual care participants for visit 3, p = 0.05). Intervention caregivers were significantly more likely to want to receive future text message reminders for vaccines and other appointments and were more willing to pay for these reminders.
CONCLUSION


Caregivers who were sent text message reminders in urban and rural Guatemala were less delayed for their child's immunization visits and reported high user satisfaction. Text message reminders may be an effective tool to increase infant vaccination coverage in low-income settings by reminding parents to vaccinate.
TRIAL REGISTRATION


NCT02567006 at clinicaltrials.gov.",2019,"CONCLUSION


Caregivers who were sent text message reminders in urban and rural Guatemala were less delayed for their child's immunization visits and reported high user satisfaction.","['infant immunization in Guatemala', 'Of 1088 families approached for enrollment between March to November 2016, 871 were eligible and 720 (82.7%) participated; only 54 families did not own a cell phone', 'four public health clinics in rural and urban Guatemala', 'Infants ages six weeks to six months presenting for the first visit of the primary immunization series']",['intervention or usual care group'],"['timeliness of the second and third visits of the primary immunization series', 'rates of visit completion']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1136359', 'cui_str': 'Cell Phone'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1328526', 'cui_str': 'Primary immunization'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1328526', 'cui_str': 'Primary immunization'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}]",871.0,0.107779,"CONCLUSION


Caregivers who were sent text message reminders in urban and rural Guatemala were less delayed for their child's immunization visits and reported high user satisfaction.","[{'ForeName': 'Gretchen J', 'Initials': 'GJ', 'LastName': 'Domek', 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, B065, 13123 E. 16th Ave., Aurora, CO 80045, USA; Center for Global Health, Colorado School of Public Health, A090, 13199 E. Montview Blvd., Suite 310, Aurora, CO 80045, USA. Electronic address: gretchen.domek@childrenscolorado.org.'}, {'ForeName': 'Ingrid L', 'Initials': 'IL', 'LastName': 'Contreras-Roldan', 'Affiliation': 'Center for Health Studies, Universidad del Valle de Guatemala, 18 Av. 11-95, Zona 15, Vista Hermosa III, Guatemala City, Guatemala.'}, {'ForeName': 'Sheana', 'Initials': 'S', 'LastName': 'Bull', 'Affiliation': 'Center for Global Health, Colorado School of Public Health, A090, 13199 E. Montview Blvd., Suite 310, Aurora, CO 80045, USA; Department of Community and Behavioral Health, Colorado School of Public Health, B119, 13001 E. 17th Place, Aurora, CO 80045, USA.'}, {'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, B065, 13123 E. 16th Ave., Aurora, CO 80045, USA; Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado Anschutz Medical Campus, F443, 13199 E. Montview Blvd., Suite 300, Aurora, CO 80045, USA.'}, {'ForeName': 'Guillermo Antonio', 'Initials': 'GA', 'LastName': 'Bolaños Ventura', 'Affiliation': 'Center for Human Development at the Southwest Trifinio, Finca Mojarras, Aldea Los Encuentros, Caballo Blanco, Retalhuleu, Guatemala.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bronsert', 'Affiliation': 'Center for Global Health, Colorado School of Public Health, A090, 13199 E. Montview Blvd., Suite 310, Aurora, CO 80045, USA; Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado Anschutz Medical Campus, F443, 13199 E. Montview Blvd., Suite 300, Aurora, CO 80045, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kempe', 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, B065, 13123 E. 16th Ave., Aurora, CO 80045, USA; Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado Anschutz Medical Campus, F443, 13199 E. Montview Blvd., Suite 300, Aurora, CO 80045, USA.'}, {'ForeName': 'Edwin J', 'Initials': 'EJ', 'LastName': 'Asturias', 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, B065, 13123 E. 16th Ave., Aurora, CO 80045, USA; Center for Global Health, Colorado School of Public Health, A090, 13199 E. Montview Blvd., Suite 310, Aurora, CO 80045, USA; Department of Epidemiology, Colorado School of Public Health, B119, 13001 E. 17th Place, Aurora, CO 80045, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.08.046']
3578,32092060,Safety and immune responses after a 12-month booster in healthy HIV-uninfected adults in HVTN 100 in South Africa: A randomized double-blind placebo-controlled trial of ALVAC-HIV (vCP2438) and bivalent subtype C gp120/MF59 vaccines.,"BACKGROUND


HVTN 100 evaluated the safety and immunogenicity of an HIV subtype C pox-protein vaccine regimen, investigating a 12-month booster to extend vaccine-induced immune responses.
METHODS AND FINDINGS


A phase 1-2 randomized double-blind placebo-controlled trial enrolled 252 participants (210 vaccine/42 placebo; median age 23 years; 43% female) between 9 February 2015 and 26 May 2015. Vaccine recipients received ALVAC-HIV (vCP2438) alone at months 0 and 1 and with bivalent subtype C gp120/MF59 at months 3, 6, and 12. Antibody (IgG, IgG3 binding, and neutralizing) and CD4+ T-cell (expressing interferon-gamma, interleukin-2, and CD40 ligand) responses were evaluated at month 6.5 for all participants and at months 12, 12.5, and 18 for a randomly selected subset. The primary analysis compared IgG binding antibody (bAb) responses and CD4+ T-cell responses to 3 vaccine-matched antigens at peak (month 6.5 versus 12.5) and durability (month 12 versus 18) timepoints; IgG responses to CaseA2_gp70_V1V2.B, a primary correlate of risk in RV144, were also compared at these same timepoints. Secondary and exploratory analyses compared IgG3 bAb responses, IgG bAb breadth scores, neutralizing antibody (nAb) responses, antibody-dependent cellular phagocytosis, CD4+ polyfunctionality responses, and CD4+ memory sub-population responses at the same timepoints. Vaccines were generally safe and well tolerated. During the study, there were 2 deaths (both in the vaccine group and both unrelated to study products). Ten participants became HIV-infected during the trial, 7% (3/42) of placebo recipients and 3% (7/210) of vaccine recipients. All 8 serious adverse events were unrelated to study products. Less waning of immune responses was seen after the fifth vaccination than after the fourth, with higher antibody and cellular response rates at month 18 than at month 12: IgG bAb response rates to 1086.C V1V2, 21.0% versus 9.7% (difference = 11.3%, 95% CI = 0.6%-22.0%, P = 0.039), and ZM96.C V1V2, 21.0% versus 6.5% (difference = 14.5%, 95% CI = 4.1%-24.9%, P = 0.004). IgG bAb response rates to all 4 primary V1V2 antigens were higher 2 weeks after the fifth vaccination than 2 weeks after the fourth vaccination: 87.7% versus 75.4% (difference = 12.3%, 95% CI = 1.7%-22.9%, P = 0.022) for 1086.C V1V2, 86.0% versus 63.2% (difference = 22.8%, 95% CI = 9.1%-36.5%, P = 0.001) for TV1c8.2.C V1V2, 67.7% versus 44.6% (difference = 23.1%, 95% CI = 10.4%-35.7%, P < 0.001) for ZM96.C V1V2, and 81.5% versus 60.0% (difference = 21.5%, 95% CI = 7.6%-35.5%, P = 0.002) for CaseA2_gp70_V1V2.B. IgG bAb response rates to the 3 primary vaccine-matched gp120 antigens were all above 90% at both peak timepoints, with no significant differences seen, except a higher response rate to ZM96.C gp120 at month 18 versus month 12: 64.5% versus 1.6% (difference = 62.9%, 95% CI = 49.3%-76.5%, P < 0.001). CD4+ T-cell response rates were higher at month 18 than month 12 for all 3 primary vaccine-matched antigens: 47.3% versus 29.1% (difference = 18.2%, 95% CI = 2.9%-33.4%, P = 0.021) for 1086.C, 61.8% versus 38.2% (difference = 23.6%, 95% CI = 9.5%-37.8%, P = 0.001) for TV1.C, and 63.6% versus 41.8% (difference = 21.8%, 95% CI = 5.1%-38.5%, P = 0.007) for ZM96.C, with no significant differences seen at the peak timepoints. Limitations were that higher doses of gp120 were not evaluated, this study was not designed to investigate HIV prevention efficacy, and the clinical significance of the observed immunological effects is uncertain.
CONCLUSIONS


In this study, a 12-month booster of subtype C pox-protein vaccines restored immune responses, and slowed response decay compared to the 6-month vaccination.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02404311. South African National Clinical Trials Registry (SANCTR number: DOH--27-0215-4796).",2020,"CD4+ T-cell response rates were higher at month 18 than month 12 for all 3 primary vaccine-matched antigens: 47.3% versus 29.1% (difference = 18.2%, 95% CI = 2.9%-33.4%, P = 0.021) for 1086.C, 61.8% versus 38.2% (difference = 23.6%, 95% CI = 9.5%-37.8%, P = 0.001) for TV1.C, and 63.6% versus 41.8% (difference = 21.8%, 95% CI = 5.1%-38.5%, P = 0.007) for ZM96.C, with no significant differences seen at the peak timepoints.","['252 participants (210 vaccine/42 placebo; median age 23 years; 43% female) between 9 February 2015 and 26 May 2015', 'healthy HIV-uninfected adults in HVTN 100 in South Africa']","['placebo', 'ALVAC-HIV (vCP2438) alone at months 0 and 1 and with bivalent subtype C gp120/MF59', 'expressing interferon-gamma, interleukin-2, and CD40 ligand', 'ALVAC-HIV (vCP2438) and bivalent subtype C gp120/MF59 vaccines']","['safe and well tolerated', 'cellular response rates', 'CD4+ T-cell response rates', 'IgG binding antibody (bAb) responses and CD4+ T-cell responses', 'IgG bAb response rates', 'HIV prevention efficacy', 'durability', 'Antibody (IgG, IgG3 binding, and neutralizing) and CD4+ T-cell ', 'Safety and immune responses', 'IgG3 bAb responses, IgG bAb breadth scores, neutralizing antibody (nAb) responses, antibody-dependent cellular phagocytosis, CD4+ polyfunctionality responses, and CD4+ memory sub-population responses']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0675907', 'cui_str': 'ALVAC-HIV'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0019691', 'cui_str': 'Envelope Glycoprotein gp120, HIV'}, {'cui': 'C0289787', 'cui_str': 'MF59'}, {'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0167627', 'cui_str': 'T-B Cell Activating Molecule'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0020859', 'cui_str': 'IgG3'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",252.0,0.458219,"CD4+ T-cell response rates were higher at month 18 than month 12 for all 3 primary vaccine-matched antigens: 47.3% versus 29.1% (difference = 18.2%, 95% CI = 2.9%-33.4%, P = 0.021) for 1086.C, 61.8% versus 38.2% (difference = 23.6%, 95% CI = 9.5%-37.8%, P = 0.001) for TV1.C, and 63.6% versus 41.8% (difference = 21.8%, 95% CI = 5.1%-38.5%, P = 0.007) for ZM96.C, with no significant differences seen at the peak timepoints.","[{'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Laher', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Moodie', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Kristen W', 'Initials': 'KW', 'LastName': 'Cohen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Grunenberg', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Yates', 'Affiliation': 'Departments of Surgery and Immunology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'Mookho', 'Initials': 'M', 'LastName': 'Malahleha', 'Affiliation': 'Setshaba Research Centre, Soshanguve, South Africa.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Mngadi', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, Durban, South Africa.'}, {'ForeName': 'Brodie', 'Initials': 'B', 'LastName': 'Daniels', 'Affiliation': 'South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Innes', 'Affiliation': 'Aurum Institute, Klerksdorp Research Centre, Klerksdorp, South Africa.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Saunders', 'Affiliation': 'Departments of Surgery and Immunology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Grant', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Phogat', 'Affiliation': 'Sanofi Pasteur, Swiftwater, Pennsylvania, United States of America.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'DiazGranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, Pennsylvania, United States of America.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Koutsoukos', 'Affiliation': 'GSK Vaccines, Rixensart, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Van Der Meeren', 'Affiliation': 'GSK Vaccines, Rixensart, Belgium.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Bentley', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Nonhlanhla N', 'Initials': 'NN', 'LastName': 'Mkhize', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Pensiero', 'Affiliation': 'Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Vijay L', 'Initials': 'VL', 'LastName': 'Mehra', 'Affiliation': 'Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Departments of Surgery and Immunology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.'}, {'ForeName': 'Glenda E', 'Initials': 'GE', 'LastName': 'Gray', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Departments of Surgery and Immunology, Duke Human Vaccine Institute, Durham, North Carolina, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003038']
3579,30514795,Randomized controlled trial of individualized treatment summary and survivorship care plans for hematopoietic cell transplantation survivors.,"Survivorship Care Plans (SCPs) may facilitate long-term care for cancer survivors, but their effectiveness has not been established in hematopoietic cell transplantation recipients. We evaluated the impact of individualized SCPs on patient-reported outcomes among transplant survivors. Adult (≥18 years at transplant) survivors who were 1-5 years post transplantation, proficient in English, and without relapse or secondary cancers were eligible for this multicenter randomized trial. SCPs were developed based on risk-factors and treatment exposures using patient data routinely submitted by transplant centers to the Center for International Blood and Marrow Transplant Research and published guidelines for long-term follow up of transplant survivors. Phone surveys assessing patient-reported outcomes were conducted at baseline and at 6 months. The primary end point was confidence in survivorship information, and secondary end points included cancer and treatment distress, knowledge of transplant exposures, health care utilization, and health-related quality of life. Of 495 patients enrolled, 458 completed a baseline survey and were randomized (care plan=231, standard care=227); 200 (87%) and 199 (88%) completed the 6-month assessments, respectively. Patients' characteristics were similar in the two arms. Participants on the care plan arm reported significantly lower distress scores at 6 months and an increase in the Mental Component Summary quality of life score assessed by the Short Form 12 (SF-12) instrument. No effect was observed on the end point of confidence in survivorship information or other secondary outcomes. Provision of individualized SCPs generated using registry data was associated with reduced distress and improved mental domain of quality of life among 1-5 year hematopoietic cell transplantation survivors. Trial registered at  clinicaltrials.gov 02200133 .",2019,Participants on the care plan arm reported significantly lower distress scores at 6 months and an increase in the Mental Component Summary quality of life score assessed by the Short Form 12 (SF-12) instrument.,"['survivors who were 1-5 years post transplantation, proficient in English, and without relapse or secondary cancers', '495 patients enrolled, 458 completed a baseline survey and were randomized (care plan=231, standard care=227); 200 (87%) and 199 (88%) completed the 6-month assessments, respectively', 'cancer survivors', 'Adult (≥18 years at transplant', 'hematopoietic cell transplantation survivors', 'hematopoietic cell transplantation recipients', 'transplant survivors']","['individualized SCPs', 'Survivorship Care Plans (SCPs', 'individualized treatment summary and survivorship care plans']","['reduced distress and improved mental domain of quality of life', 'lower distress scores', 'Mental Component Summary quality of life score', 'confidence in survivorship information, and secondary end points included cancer and treatment distress, knowledge of transplant exposures, health care utilization, and health-related quality of life']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4534427', 'cui_str': 'Proficient in English (finding)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2939419', 'cui_str': 'Metastatic cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]","[{'cui': 'C0038955'}, {'cui': 'C0178916', 'cui_str': 'Care plan (record artifact)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0034380'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0038955'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",495.0,0.142494,Participants on the care plan arm reported significantly lower distress scores at 6 months and an increase in the Mental Component Summary quality of life score assessed by the Short Form 12 (SF-12) instrument.,"[{'ForeName': 'Navneet S', 'Initials': 'NS', 'LastName': 'Majhail', 'Affiliation': 'Blood and Marrow Transplant Program, Cleveland Clinic, OH majhain@ccf.org.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Murphy', 'Affiliation': 'National Marrow Donor Program/Be The Match, Minneapolis, MN.'}, {'ForeName': 'Purushottam', 'Initials': 'P', 'LastName': 'Laud', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Jaime M', 'Initials': 'JM', 'LastName': 'Preussler', 'Affiliation': 'National Marrow Donor Program/Be The Match, Minneapolis, MN.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Denzen', 'Affiliation': 'National Marrow Donor Program/Be The Match, Minneapolis, MN.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Abetti', 'Affiliation': 'Leukemia and Lymphoma Society, White Plains, NY.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Minneapolis, MN.'}, {'ForeName': 'RaeAnne', 'Initials': 'R', 'LastName': 'Besser', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Minneapolis, MN.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Burns', 'Affiliation': 'National Marrow Donor Program/Be The Match, Minneapolis, MN.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Cerny', 'Affiliation': 'UMass Memorial Medical Center, Worcester, MA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Drexler', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Minneapolis, MN.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Hahn', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Lensa', 'Initials': 'L', 'LastName': 'Idossa', 'Affiliation': 'National Marrow Donor Program/Be The Match, Minneapolis, MN.'}, {'ForeName': 'Balkrishna', 'Initials': 'B', 'LastName': 'Jahagirdar', 'Affiliation': 'Regions Hospital, St Paul, MN.'}, {'ForeName': 'Naynesh', 'Initials': 'N', 'LastName': 'Kamani', 'Affiliation': 'AABB, Bethesda, MD.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Loren', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Mattila', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Minneapolis, MN.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'McGuirk', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Moore', 'Affiliation': 'National Marrow Donor Program/Be The Match, Minneapolis, MN.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Reynolds', 'Affiliation': 'Baylor University Medical Center, Dallas, TX.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Saber', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Lizette', 'Initials': 'L', 'LastName': 'Salazar', 'Affiliation': 'Haledon, NJ.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Schatz', 'Affiliation': 'Loyola University Medical Center, Chicago, IL.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stiff', 'Affiliation': 'Loyola University Medical Center, Chicago, IL.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Wingard', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Syrjala', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'K Scott', 'Initials': 'KS', 'LastName': 'Baker', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}]",Haematologica,['10.3324/haematol.2018.203919']
3580,31211416,Effect of Vitamin K2 on Postural Sway in Older People Who Fall: A Randomized Controlled Trial.,"OBJECTIVES


Vitamin K is thought to be involved in both bone health and maintenance of neuromuscular function. We tested the effect of vitamin K2 supplementation on postural sway, falls, healthcare costs, and indices of physical function in older people at risk of falls.
DESIGN


Parallel-group double-blind randomized placebo-controlled trial.
SETTING


Fourteen primary care practices in Scotland, UK.
PARTICIPANTS


A total of 95 community-dwelling participants aged 65 and older with at least two falls, or one injurious fall, in the previous year.
INTERVENTION


Once/day placebo, 200 μg or 400 μg of oral vitamin K2 for 1 year.
MEASUREMENTS


The primary outcome was anteroposterior sway measured using sway plates at 12 months, adjusted for baseline. Secondary outcomes included the Short Physical Performance Battery, Berg Balance Scale, Timed Up & Go Test, quality of life, health and social care costs, falls, and adverse events.
RESULTS


Mean participant age was 75 (standard deviation [SD] = 7) years. Overall, 58 of 95 (61%) were female; 77 of 95 (81%) attended the 12-month visit. No significant effect of either vitamin K2 dose was seen on the primary outcome of anteroposterior sway (200 μg vs placebo: -.19 cm [95% confidence interval [CI] -.68 to .30; P = .44]; 400 μg vs placebo: .17 cm [95% CI -.33 to .66; P = .50]; or 400 μg vs 200 μg: .36 cm [95% CI -.11 to .83; P = .14]). Adjusted falls rates were similar in each group. No significant treatment effects were seen for other measures of sway or secondary outcomes. Costs were higher in both vitamin K2 arms than in the placebo arm.
CONCLUSION


Oral vitamin K2 supplementation did not improve postural sway or physical function in older people at risk of falls. J Am Geriatr Soc 67:2102-2107, 2019.",2019,No significant effect of either vitamin K2 dose was seen on the primary outcome of anteroposterior sway (200 μg vs placebo: -.19 ,"['Mean participant age was 75 (standard deviation [SD] = 7) years', 'Fourteen primary care practices in Scotland, UK', 'Older People', '95 community-dwelling participants aged 65 and older with at least two falls, or one injurious fall, in the previous year', 'older people at risk of falls', 'Who Fall']","['placebo', 'vitamin K2', 'Oral vitamin K2 supplementation', 'Vitamin K2', 'vitamin K2 supplementation']","['anteroposterior sway', 'anteroposterior sway measured using sway plates', 'Short Physical Performance Battery, Berg Balance Scale, Timed Up & Go Test, quality of life, health and social care costs, falls, and adverse events', 'postural sway or physical function', 'Adjusted falls rates', 'postural sway, falls, healthcare costs, and indices of physical function', 'Costs', 'Postural Sway']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care (regime/therapy)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",95.0,0.792045,No significant effect of either vitamin K2 dose was seen on the primary outcome of anteroposterior sway (200 μg vs placebo: -.19 ,"[{'ForeName': 'Miles D', 'Initials': 'MD', 'LastName': 'Witham', 'Affiliation': 'AGE Research Group, NIHR Newcastle Biomedical Research Centre, Newcastle University and Newcastle upon Tyne Hospitals Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Rosemary J G', 'Initials': 'RJG', 'LastName': 'Price', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Band', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Hannah', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Roberta L', 'Initials': 'RL', 'LastName': 'Fulton', 'Affiliation': 'School of Nursing, Abertay University, Dundee, United Kingdom.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Clarke', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McNamee', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Cvoro', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK and NHS Fife, Kirkcaldy, United Kingdom.'}, {'ForeName': 'Roy L', 'Initials': 'RL', 'LastName': 'Soiza', 'Affiliation': 'Ageing Clinical and Experimental Research, School of Medicine & Dentistry, University of Aberdeen, Aberdeen, United Kingdom.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16024']
3581,30514803,Imatinib dose reduction in major molecular response of chronic myeloid leukemia: results from the German Chronic Myeloid Leukemia-Study IV.,"Standard first-line therapy of chronic myeloid leukemia is treatment with imatinib. In the randomized German Chronic Myeloid Leukemia-Study IV, more potent BCR-ABL inhibition with 800 mg ('high-dose') imatinib accelerated achievement of a deep molecular remission. However, whether and when a de-escalation of the dose intensity under high-dose imatinib can be safely performed without increasing the risk of losing deep molecular response is unknown. To gain insights into this clinically relevant question, we analyzed the outcome of imatinib dose reductions from 800 mg to 400 mg daily in the Chronic Myeloid Leukemia-Study IV. Of the 422 patients that were randomized to the 800 mg arm, 68 reduced imatinib to 400 mg after they had achieved at least a stable major molecular response. Of these 68 patients, 61 (90%) maintained major molecular remission on imatinib at 400 mg. Five of the seven patients who lost major molecular remission on the imatinib standard dose regained major molecular remission while still on 400 mg imatinib. Only two of 68 patients had to switch to more potent kinase inhibition to regain major molecular remission. Importantly, the lengths of the intervals between imatinib high-dose treatment before and after achieving major molecular remission were associated with the probabilities of maintaining major molecular remission with the standard dose of imatinib. Taken together, the data support the view that a deep molecular remission achieved with high-dose imatinib can be safely maintained with standard dose in most patients. Study protocol registered at  clinicaltrials.gov 00055874 .",2019,"In the randomized German Chronic Myeloid Leukemia-Study IV, more potent BCR-ABL inhibition with 800 mg ('high-dose') imatinib accelerated achievement of a deep molecular remission.","['422 patients', 'chronic myeloid leukemia']","['imatinib', 'Imatinib']",['major molecular remission'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}]","[{'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.0579106,"In the randomized German Chronic Myeloid Leukemia-Study IV, more potent BCR-ABL inhibition with 800 mg ('high-dose') imatinib accelerated achievement of a deep molecular remission.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Michel', 'Affiliation': 'Universitätsklinikum Gießen und Marburg, Campus Marburg, Klinik für Hämatologie, Onkologie und Immunologie, Philipps Universität Marburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Burchert', 'Affiliation': 'Universitätsklinikum Gießen und Marburg, Campus Marburg, Klinik für Hämatologie, Onkologie und Immunologie, Philipps Universität Marburg, Germany burchert@staff.uni-marburg.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': 'Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie, Jena, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Saussele', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, University Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Neubauer', 'Affiliation': 'Universitätsklinikum Gießen und Marburg, Campus Marburg, Klinik für Hämatologie, Onkologie und Immunologie, Philipps Universität Marburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lauseker', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'Stefan W', 'Initials': 'SW', 'LastName': 'Krause', 'Affiliation': 'Medizinische Klinik 5, Universitätsklinikum, Erlangen, Germany.'}, {'ForeName': 'Hans-Jochem', 'Initials': 'HJ', 'LastName': 'Kolb', 'Affiliation': 'Medizinische Klinik III, Universität München, Germany.'}, {'ForeName': 'Dieter Kurt', 'Initials': 'DK', 'LastName': 'Hossfeld', 'Affiliation': 'Medizinische Klinik, Universitätsklinikum Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nerl', 'Affiliation': 'Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Gabriela M', 'Initials': 'GM', 'LastName': 'Baerlocher', 'Affiliation': 'Inselspital, Bern, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Heim', 'Affiliation': 'Universitätsspital, Basel, Switzerland.'}, {'ForeName': 'Tim H', 'Initials': 'TH', 'LastName': 'Brümmendorf', 'Affiliation': 'RWTH, Aachen, Germany.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Fabarius', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, University Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Haferlach', 'Affiliation': 'MLL, Munich, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Schlegelberger', 'Affiliation': 'Institut für Humangenetik, MHH, Hannover, Germany.'}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Balleisen', 'Affiliation': 'Ev. Krankenhaus, Hamm, Germany.'}, {'ForeName': 'Maria-Elisabeth', 'Initials': 'ME', 'LastName': 'Goebeler', 'Affiliation': 'Comprehensive Cancer Center Mainfranken und Medizinische Klinik II, Zentrum für Innere Medizin, Würzburg, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hänel', 'Affiliation': 'Klinik für Innere Medizin 3, Chemnitz, Germany.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ho', 'Affiliation': 'Medizinische Klinik V, Universität Heidelberg, Germany.'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Dengler', 'Affiliation': 'Onkologische Schwerpunktpraxis, Heilbronn, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Falge', 'Affiliation': 'Medizinische Klinik 5, Klinikum Nürnberg-Nord, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Möhle', 'Affiliation': 'Medizinische Abteilung 2, Universitätsklinikum, Tübingen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kremers', 'Affiliation': 'Caritas Krankenhaus, Lebach, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kneba', 'Affiliation': '2. Medizinische Klinik und Poliklinik, Universitätsklinikum Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Stegelmann', 'Affiliation': 'Klinik für Innere Medizin 3, Universitätsklinikum, Ulm, Germany.'}, {'ForeName': 'Claus-Henning', 'Initials': 'CH', 'LastName': 'Köhne', 'Affiliation': 'Universitätsklinik für Onkologie und Hämatologie, Oldenburg, Germany.'}, {'ForeName': 'Hans-Walter', 'Initials': 'HW', 'LastName': 'Lindemann', 'Affiliation': 'St Marien-Hospital, Hagen, Germany.'}, {'ForeName': 'Cornelius F', 'Initials': 'CF', 'LastName': 'Waller', 'Affiliation': 'Innere Medizin 1, Universitätsklinikum, Freiburg, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Spiekermann', 'Affiliation': 'Medizinische Klinik III, Universität München, Germany.'}, {'ForeName': 'Wolfgang E', 'Initials': 'WE', 'LastName': 'Berdel', 'Affiliation': 'Medizinische Klinik A, Universitätsklinikum, Münster, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Müller', 'Affiliation': 'Onkologie Leer Unter Ems, Leer, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Edinger', 'Affiliation': 'Klinik und Poliklinik für Innere Medizin 3, Universitätsklinikum, Regensburg, Germany.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Mayer', 'Affiliation': 'Masaryk University Hospital, Brno, Czech Republic.'}, {'ForeName': 'Dietrich W', 'Initials': 'DW', 'LastName': 'Beelen', 'Affiliation': 'Klinik für Knochenmarktransplantation, Essen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bentz', 'Affiliation': 'Medizinische Klinik 3, Städtisches Klinikum, Karlsruhe, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Link', 'Affiliation': 'Hematology, Medical Oncology, Kaiserslautern, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': '1. Medizinische Klinik, Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Fuchs', 'Affiliation': 'RWTH, Aachen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wernli', 'Affiliation': 'Kantonsspital, Aarau, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schlegel', 'Affiliation': 'St Antonius-Hospital, Eschweiler, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Schlag', 'Affiliation': 'Hämatologische-Onkologische Schwerpunktpraxis, Würzburg, Germany.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'de Wit', 'Affiliation': 'Klinik für Innere Medizin II, Hämatologie, Onkologie und Palliativmedizin, Vivantes Klinikum Neukölln, Berlin, Germany.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Trümper', 'Affiliation': 'Klinik für Hämatologie und medizinische Onkologie, Universitätsmedizin, Göttingen, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Hebart', 'Affiliation': 'Stauferklinikum Schwäbisch Gmünd, Mutlangen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hahn', 'Affiliation': 'Onkologie Zentrum, Ansbach, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Thomalla', 'Affiliation': 'Praxisklinik für Hämatologie und Onkologie, Koblenz, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Scheid', 'Affiliation': 'Klinik 1 für Innere Medizin, Universitätsklinikum, Köln, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'Medizinische Klinik, Universitätsklinikum Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Verbeek', 'Affiliation': 'Ambulante Hämatologie und Onkologie, Bonn, Germany.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Eckart', 'Affiliation': 'Internistische Schwerpunktpraxis, Erlangen, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Gassmann', 'Affiliation': 'St Marien-Krankenhaus, Siegen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenk', 'Affiliation': 'Barmherzige Brüder, Regensburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brossart', 'Affiliation': 'Medizinische Klinik 3, Universität, Bonn, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wündisch', 'Affiliation': 'Universitätsklinikum Gießen und Marburg, Campus Marburg, Klinik für Hämatologie, Onkologie und Immunologie, Philipps Universität Marburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Geer', 'Affiliation': 'Diakonie, Schwäbisch Hall, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Bildat', 'Affiliation': 'Medizinische Klinik 2, Herford, Germany.'}, {'ForeName': 'Erhardt', 'Initials': 'E', 'LastName': 'Schäfer', 'Affiliation': 'Onkologische Schwerpunktpraxis, Bielefeld, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Hehlmann', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, University Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pfirrmann', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität München, Munich, Germany.'}]",Haematologica,['10.3324/haematol.2018.206797']
3582,32142501,"What Is the Effect of Vitamin C on Finger Stiffness After Distal Radius Fracture? A Double-blind, Placebo-controlled Randomized Trial.","BACKGROUND


It is proposed that vitamin C administration can reduce disproportionate pain and stiffness after distal radius fracture; however, randomized trials that tested this hypothesis have had inconsistent results.
QUESTIONS/PURPOSES


(1) Is administering vitamin C after distal radius fracture associated with better ROM, patient-reported upper extremity function, and pain scores? (2) What factors are associated with post-fracture finger stiffness and worse upper extremity function?
METHODS


This is a double-blind, randomized, placebo-controlled, noncrossover study. Between August 2014 and July 2017, we approached 204 consecutive patients, of which 195 were eligible, and 134 chose to participate. Participants were randomized to receive once-daily 500 mg vitamin C (67 participants) or placebo (67 participants) within 2 weeks after distal radius fracture. All patients received usual care at the discretion of their surgeon. The mean age of participants was 49 ± 17 years, 99 patients (74%) were women, and 83 (62%) were treated nonoperatively. The primary outcome was the distance between the fingertip and distal palmar crease 6 weeks after fracture. This measure is easy to obtain and previously has been shown to correlate with aggregate ROM of all finger joints. The secondary outcomes were total active finger motion, total active thumb motion, upper extremity-specific limitations, and pain intensity.An a priori power analysis suggested 126 patients would provide 80% power to detect a difference of 2 cm (SD 4.0) fingertip distance to palmar crease with α set at 0.05 using a two-tailed Student's t-test. Accounting for 5% lost to followup, we included 134 patients.All analyses were intention-to-treat. Ten participants of the intervention group and five of the placebo group were lost to followup. Their missing data were addressed by multiple imputation, after which we performed linear regression analysis for our outcome variables.
RESULTS


Administration of vitamin C was not associated with ROM, function, or pain scores at 6 weeks (distance to palmar crease: β -0.23; 95% CI -1.7 to 1.2; p = 0.754; finger ROM: β 4.9; 95% CI, -40 to 50; p = 0.829; thumb ROM: β 0.98; 95% CI, -18 to 20; p = 0.918, Patient-Reported Outcomes Measurement Information System [PROMIS] score: β 0.32; 95% CI, -2.6 to 3.2; p = 0.828; pain score: β -0.62; 95% CI, -0.62 to 0.89; p = 0.729) nor at 6 months (PROMIS score: β -0.21; 95% CI, -3.7 to 3.3; p = 0.904; pain score: β 0.31; 95% CI, -0.74 to 1.4; p = 0.559). At 6 weeks, we found that more finger stiffness was mildly associated with greater age (β -1.5; 95% CI, -2.8 to -0.083; p = 0.038). Thumb stiffness was mildly associated with greater age (β -0.72; 95% CI, -1.3 to -0.18; p = 0.009) and strongly associated with operative treatment (β -32; 95% CI, -50 to -13; p = 0.001). Greater pain interference was modestly associated with greater functional limitations at 6 weeks (β -0.32; 95% CI, -0.52 to -0.12; p = 0.002) and 6 months (β -0.36; 95% CI, -0.60 to -0.11; p = 0.004).
CONCLUSIONS


Vitamin C does not seem to facilitate recovery after distal radius fracture, but amelioration of maladaptation to nociception (pain interference) merits greater attention.
LEVEL OF EVIDENCE


Level I, therapeutic study.",2019,"Thumb stiffness was mildly associated with greater age (β -0.72; 95% CI, -1.3 to -0.18; p = 0.009) and strongly associated with operative treatment (","['The mean age of participants was 49 ± 17 years, 99 patients (74%) were women, and 83 (62%) were treated nonoperatively', '134 patients', 'Between August 2014 and July 2017, we approached 204 consecutive patients, of which 195 were eligible, and 134 chose to participate']","['Vitamin C', 'Placebo', 'placebo', 'vitamin C administration', 'vitamin C']","['Greater pain interference', 'ROM, function, or pain scores', 'Thumb stiffness', 'finger stiffness', 'total active finger motion, total active thumb motion, upper extremity-specific limitations, and pain intensity', 'distance between the fingertip and distal palmar crease 6 weeks after fracture', 'Finger Stiffness']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0647859', 'cui_str': 'AM49'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0040067', 'cui_str': 'Thumb'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0239596'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0424730', 'cui_str': 'Finding of palmar crease'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]",204.0,0.596166,"Thumb stiffness was mildly associated with greater age (β -0.72; 95% CI, -1.3 to -0.18; p = 0.009) and strongly associated with operative treatment (","[{'ForeName': 'Sezai', 'Initials': 'S', 'LastName': 'Özkan', 'Affiliation': 'S. Özkan, Hand and Upper Extremity Service, Department of Orthopedic Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA; Department of Trauma Surgery, VU University Medical Center, Amsterdam, the Netherlands T. Teunis, Department of Plastic Surgery, University Medical Center Utrecht, Utrecht, the Netherlands D. C. Ring, Department of Surgery and Perioperative Care, Dell Medical School, The University of Texas at Austin, Austin, TX, USA N. C. Chen, Hand and Upper Extremity Service, Department of Orthopedic Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'Teunis', 'Affiliation': ''}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Ring', 'Affiliation': ''}, {'ForeName': 'Neal C', 'Initials': 'NC', 'LastName': 'Chen', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000807']
3583,31426749,Effects of ezetimibe/simvastatin 10/10 mg versus Rosuvastatin 10 mg on carotid atherosclerotic plaque inflammation.,"BACKGROUND


Using  18 F-fluorodeoxyglucose ( 18 FDG) positron emission tomography-computed tomography (PET/CT) imaging, we examined the effects of ezetimibe/simvastatin 10/10 mg versus rosuvastatin 10 mg on carotid atherosclerotic plaque inflammation. Whether the combination therapy of ezetimibe with low-dose statin is as effective as potent statin monotherapy in attenuating carotid atherosclerotic plaque inflammation remains unclear.
METHODS


In this 2-by-2 factorial trial, 50 patients with  18 FDG uptake (target-to-background ratio [TBR] ≥1.6) in the carotid artery and acute coronary syndrome were randomized to receive either simvastatin/ezetimibe 10/10 mg or rosuvastatin 10 mg.  18 FDG PET/CT examinations were performed at baseline and at 6 months. The percent change in the TBR of the index vessel at the most diseased segment (MDS) was the primary endpoint.
RESULTS


Baseline characteristics of the two groups were largely similar. At 6-month follow-up, the MDS TBR of the index vessel and aorta significantly decreased in ezetimibe/simvastatin group and tended to decrease in rosuvastatin group. However, the percent change in the MDS TBR of the index vessel was similar between the 2 groups (- 10.22 ± 17.49% vs. -5.84 ± 15.78%, respectively, p = 0.357), as was the percent change in the whole vessel TBR of the index vessel. Likewise, the changes in the MDS TBR or whole vessel TBR of the aorta were similar in both groups. Total cholesterol and low-density lipoprotein cholesterol levels improved to a similar degree in both groups.
CONCLUSION


Treatment with ezetimibe/simvastatin versus rosuvastatin resulted in a similar improvement of carotid atherosclerotic plaque inflammation, suggesting their equivalent anti-inflammatory effects.
TRIAL REGISTRATION


The trial is registered at ClinicalTrials.gov : NCT02378064, 3-4-2015. /IRB No. 2015-0194.",2019,"Total cholesterol and low-density lipoprotein cholesterol levels improved to a similar degree in both groups.
",['50 patients with  18 FDG uptake (target-to-background ratio [TBR] ≥1.6) in the carotid artery and acute coronary syndrome'],"['ezetimibe/simvastatin versus rosuvastatin', 'ezetimibe/simvastatin', 'rosuvastatin', 'Rosuvastatin', 'simvastatin/ezetimibe 10/10\u2009mg or rosuvastatin 10\u2009mg', 'IRB', 'ezetimibe with low-dose statin', '18 F-fluorodeoxyglucose ( 18 FDG) positron emission tomography-computed tomography (PET/CT']","['Total cholesterol and low-density lipoprotein cholesterol levels', 'MDS TBR of the index vessel and aorta', 'MDS TBR or whole vessel TBR of the aorta', 'carotid atherosclerotic plaque inflammation', 'MDS TBR of the index vessel', 'whole vessel TBR of the index vessel']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0007272', 'cui_str': 'Carotid Arteries'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C1532737', 'cui_str': 'ezetimibe / Simvastatin'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C4553797', 'cui_str': 'Fluorodeoxyglucose'}, {'cui': 'C1699633', 'cui_str': 'Positron Emission Tomography Computed Tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C2936350', 'cui_str': 'Plaque, Atherosclerotic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",18.0,0.0817676,"Total cholesterol and low-density lipoprotein cholesterol levels improved to a similar degree in both groups.
","[{'ForeName': 'Minyoung', 'Initials': 'M', 'LastName': 'Oh', 'Affiliation': 'Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyunji', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Eon Woo', 'Initials': 'EW', 'LastName': 'Shin', 'Affiliation': 'Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Changhwan', 'Initials': 'C', 'LastName': 'Sung', 'Affiliation': 'Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Do-Hoon', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dae Hyuk', 'Initials': 'DH', 'LastName': 'Moon', 'Affiliation': 'Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Cheol Whan', 'Initials': 'CW', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. cheolwlee@amc.seoul.kr.'}]",BMC cardiovascular disorders,['10.1186/s12872-019-1184-2']
3584,31464189,The Effect of the Interactive Mobile Health and Rehabilitation System on Health and Psychosocial Outcomes in Spinal Cord Injury: Randomized Controlled Trial.,"BACKGROUND


Individuals with spinal cord injury (SCI) are at risk for secondary medical complications, such as urinary tract infections (UTIs) and pressure injuries, that could potentially be mitigated through improved self-management techniques. The Interactive Mobile Health and Rehabilitation (iMHere) mobile health (mHealth) system was developed to support self-management for individuals with disabilities.
OBJECTIVE


The main objective of this study was to determine if the use of iMHere would be associated with improved health outcomes over a 9-month period. A secondary objective was to determine if the use of iMHere would be associated with improved psychosocial outcomes. Phone usage, app usage, and training time data were also collected to analyze trends in iMHere use.
METHODS


Overall, 38 participants with SCI were randomized into either the intervention group who used the iMHere system and received standard care or the control group who received standard care without any technology intervention. Health outcomes were recorded for the year before entry into the study and during the 9 months of the study. Participants completed surveys at baseline and every 3 months to measure psychosocial outcomes.
RESULTS


The intervention group had a statistically significant reduction in UTIs (0.47 events per person; P=.03; number needed to treat=2.11). Although no psychosocial outcomes changed significantly, there was a nonsignificant trend toward a reduction in mood symptoms in the intervention group compared with the control group meeting the threshold for clinical significance. Approximately 34 min per participant per month were needed on average to manage the system and provide technical support through this mHealth system.
CONCLUSIONS


The use of the iMHere mHealth system may be a valuable tool in the prevention of UTIs or reductions in depressive symptoms. Given these findings, iMHere has potential scalability for larger populations.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02592291; https://clinicaltrials.gov/ct2/show/NCT02592291.",2019,The intervention group had a statistically significant reduction in UTIs (0.47 events per person;,"['Spinal Cord Injury', '38 participants with SCI', 'individuals with disabilities', 'Individuals with spinal cord injury (SCI']","['Interactive Mobile Health and Rehabilitation System', 'intervention group who used the iMHere system and received standard care or the control group who received standard care without any technology intervention', 'Interactive Mobile Health and Rehabilitation (iMHere) mobile health (mHealth) system']","['Health and Psychosocial Outcomes', 'psychosocial outcomes', 'health outcomes', 'UTIs', 'mood symptoms']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",38.0,0.116473,The intervention group had a statistically significant reduction in UTIs (0.47 events per person;,"[{'ForeName': 'Michael Alan', 'Initials': 'MA', 'LastName': 'Kryger', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Crytzer', 'Affiliation': 'Human Engineering Research Laboratories, Department of Veterans Affairs, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fairman', 'Affiliation': 'Department of Occupational Therapy, MGH Institute of Health Professions, Boston, MA, United States.'}, {'ForeName': 'Eleanor J', 'Initials': 'EJ', 'LastName': 'Quinby', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Karavolis', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Gede', 'Initials': 'G', 'LastName': 'Pramana', 'Affiliation': 'Department of Health Information Management, School of Health and Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'I Made Agus', 'Initials': 'IMA', 'LastName': 'Setiawan', 'Affiliation': 'Department of Health Information Management, School of Health and Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Gina Pugliano', 'Initials': 'GP', 'LastName': 'McKernan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Bambang', 'Initials': 'B', 'LastName': 'Parmanto', 'Affiliation': 'Human Engineering Research Laboratories, Department of Veterans Affairs, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States.'}, {'ForeName': 'Brad E', 'Initials': 'BE', 'LastName': 'Dicianno', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States.'}]",Journal of medical Internet research,['10.2196/14305']
3585,31174162,The contribution of childhood adversity to cortisol measures of early life stress amongst infants in rural India: Findings from the early life stress sub-study of the SPRING cluster randomised controlled trial (SPRING-ELS).,"BACKGROUND


The majority of the world's children live in low- and middle-income countries and face multiple obstacles to optimal wellbeing. The mechanisms by which adversities - social, cultural, psychological, environmental, economic - get 'under the skin' in the early days of life and become biologically embedded remain an important line of enquiry. We therefore examined the contribution of childhood adversity through pregnancy and the first year of life to hair and salivary cortisol measures of early life stress in the India SPRING home visits cluster RCT which aims to improve early childhood development.
METHODS


We assessed 22 adversities across four domains: socioeconomic, maternal stress, family-child relationship, and child and summed them to make a cumulative adversity score & quintiles, and four subscale scores. We cut 3 cm of hair from the posterior vertex and took three saliva samples from morning till late afternoon on each of two days (total six samples). We analysed both for cortisol concentration using ELISA techniques. We used multiple linear regression techniques to assess the relationship between cumulative adversity and log hair cortisol concentration and saliva diurnal slope and area under the curve.
RESULTS


We assessed 712 children for hair, and 752 children for saliva cortisol at 12 months of age. We found a strong positive relationship between adversity and hair cortisol; each additional adversity factor was associated with hair cortisol increases of 6.1% (95% CI 2.8, 9.4, p < 0.001) and the increase from adversity quintile one to five was 59.4%. Socioeconomic, relationship and child scales were independent predictors of hair cortisol (socioeconomic 6.4% (95% CI -0.4, 13.6); relationship 11.8% (95% CI 1.4, 23.2); child 7.9% (95% CI -0.5, 16.9). We did not find any association between any measures of adversity and either of the saliva cortisol outcomes.
DISCUSSION


This is the largest study of hair cortisol in young children, and the first in a low- and middle-income country setting. Whilst the short-term diurnal measures of cortisol did not appear to be linked with adversity, chronic exposure over several months appears to be strongly associated with cumulative adversity. These findings should spur further work to understand the specific ways in which adversity becomes biologically embedded, and how this can be tackled. They also lend support to ongoing action to tackle childhood adversity in communities around the world.",2019,"We found a strong positive relationship between adversity and hair cortisol; each additional adversity factor was associated with hair cortisol increases of 6.1% (95% CI 2.8, 9.4, p < 0.001) and the increase from adversity quintile one to five was 59.4%.","['712 children for hair, and 752 children for saliva cortisol at 12 months of age', 'young children', 'infants in rural India']",[],"['hair cortisol increases', 'cumulative adversity and log hair cortisol concentration and saliva diurnal slope and area under the curve']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]",[],"[{'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0541847', 'cui_str': 'Cortisol increased'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",712.0,0.0706011,"We found a strong positive relationship between adversity and hair cortisol; each additional adversity factor was associated with hair cortisol increases of 6.1% (95% CI 2.8, 9.4, p < 0.001) and the increase from adversity quintile one to five was 59.4%.","[{'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhopal', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, United Kingdom. Electronic address: Sunil.Bhopal@lshtm.ac.uk.'}, {'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Verma', 'Affiliation': 'Sangath, New Delhi, India. Electronic address: Deepali.Verma@sangath.in.'}, {'ForeName': 'Reetabrata', 'Initials': 'R', 'LastName': 'Roy', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, United Kingdom. Electronic address: Reetabrata.Roy@lshtm.ac.uk.'}, {'ForeName': 'Seyi', 'Initials': 'S', 'LastName': 'Soremekun', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, United Kingdom. Electronic address: Seyi.Soremekun@lshtm.ac.uk.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Sangath, New Delhi, India. Electronic address: Divya.Kumar@sangath.in.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Bristow', 'Affiliation': 'School of Psychology and Sports Science, Anglia Ruskin University, Cambridge, United Kingdom. Electronic address: Matt.Bristow@anglia.ac.uk.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Bhanushali', 'Affiliation': 'Research & Development Division, SRL Laboratories Ltd, Mumbai, India. Electronic address: Aparna.Bhanushali@srl.in.'}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Divan', 'Affiliation': 'Sangath, New Delhi, India. Electronic address: Gauri.Divan@sangath.in.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Kirkwood', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, United Kingdom. Electronic address: Betty.Kirkwood@lshtm.ac.uk.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.05.012']
3586,31106381,"Effects on resident work hours, sleep duration, and work experience in a randomized order safety trial evaluating resident-physician schedules (ROSTERS).","STUDY OBJECTIVES


We compared resident physician work hours and sleep in a multicenter clustered-randomized crossover clinical trial that randomized resident physicians to an Extended Duration Work Roster (EDWR) with extended-duration (≥24 hr) shifts or a Rapidly Cycling Work Roster (RCWR), in which scheduled shift lengths were limited to 16 or fewer consecutive hours.
METHODS


Three hundred two resident physicians were enrolled and completed 370 1 month pediatric intensive care unit rotations in six US academic medical centers. Sleep was objectively estimated with wrist-worn actigraphs. Work hours and subjective sleep data were collected via daily electronic diary.
RESULTS


Resident physicians worked fewer total hours per week during the RCWR compared with the EDWR (61.9 ± 4.8 versus 68.4 ± 7.4, respectively; p < 0.0001). During the RCWR, 73% of work hours occurred within shifts of ≤16 consecutive hours. In contrast, during the EDWR, 38% of work hours occurred on shifts of ≤16 consecutive hours. Resident physicians obtained significantly more sleep per week on the RCWR (52.9 ± 6.0 hr) compared with the EDWR (49.1 ± 5.8 hr, p < 0.0001). The percentage of 24 hr intervals with less than 4 hr of actigraphically measured sleep was 9% on the RCWR and 25% on the EDWR (p < 0.0001).
CONCLUSIONS


RCWRs were effective in reducing weekly work hours and the occurrence of >16 consecutive hour shifts, and improving sleep duration of resident physicians. Although inclusion of the six operational healthcare sites increases the generalizability of these findings, there was heterogeneity in schedule implementation. Additional research is needed to optimize scheduling practices allowing for sufficient sleep prior to all work shifts.Clinical Trial: Multicenter Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety (ROSTERS), https://clinicaltrials.gov/ct2/show/NCT02134847.",2019,"Resident physicians obtained significantly more sleep per week on the RCWR (52.9±6.0 hours) compared to the EDWR (49.1±5.8 hours, p<0.0001).",['302 resident physicians were enrolled and completed 370 one-month pediatric intensive care unit rotations in six U.S. academic medical centers'],['Extended Duration Work Roster (EDWR) with extended-duration (≥24 hours) shifts or a Rapidly Cycling Work Roster (RCWR'],"['Work hours and subjective sleep data', 'Sleep', 'percentage of 24-hour intervals']","[{'cui': 'C1320928', 'cui_str': 'Resident physician (occupation)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.0379673,"Resident physicians obtained significantly more sleep per week on the RCWR (52.9±6.0 hours) compared to the EDWR (49.1±5.8 hours, p<0.0001).","[{'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Barger', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Sullivan', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Blackwell', 'Affiliation': 'California Pacific Medical Center Research Institute, San Francisco, CA.'}, {'ForeName': 'Conor S', 'Initials': 'CS', 'LastName': ""O'Brien"", 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'St Hilaire', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Shadab A', 'Initials': 'SA', 'LastName': 'Rahman', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Andrew J K', 'Initials': 'AJK', 'LastName': 'Phillips', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Qadri', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Segar', 'Affiliation': ""University of Iowa Stead Family Children's Hospital, Iowa City, IA.""}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'McGuire', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Vitiello', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Horacio O', 'Initials': 'HO', 'LastName': 'de la Iglesia', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Poynter', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH.""}, {'ForeName': 'Pearl L', 'Initials': 'PL', 'LastName': 'Yu', 'Affiliation': ""University of Virginia Children's Hospital, Charlottesville, VA.""}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Zee', 'Affiliation': 'Department of Neurology, Northwestern University, Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Sanderson', 'Affiliation': ""Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Halbower', 'Affiliation': ""Children's Hospital Colorado Anschutz Medical Campus, Aurora, CO.""}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Landrigan', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Stone', 'Affiliation': 'California Pacific Medical Center Research Institute, San Francisco, CA.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Czeisler', 'Affiliation': ""Department of Medicine and Neurology, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Sleep,['10.1093/sleep/zsz110']
3587,30545921,Replacing cyclophosphamide/cytarabine/mercaptopurine with cyclophosphamide/etoposide during consolidation/delayed intensification does not improve outcome for pediatric B-cell acute lymphoblastic leukemia: a report from the COG.,"With modern chemotherapy, approximately 90% of patients with pediatric acute lymphoblastic leukemia are now cured. However, subsets of patients can be identified who remain at very high risk of relapse with expected 4-year disease-free survival rates <80%; such patients are appropriate candidates for intensive therapeutic strategies designed to improve survival. The AALL1131 trial was designed to determine, in a randomized fashion, whether substitution with cyclophosphamide/etoposide (experimental arm 1) would improve the 4-year disease-free survival of children, adolescents, and young adults with very high-risk B-cell acute lymphoblastic leukemia compared to a modified Berlin-Frankfurt-Münster regimen (control arm). Patients 1-30 years of age with newly diagnosed very high-risk B-cell acute lymphoblastic leukemia were randomized after induction in a 1:2 fashion to the control arm or experimental arm 1 in which they were given cyclophosphamide (440 mg/m 2  days 1-5)/etoposide (100 mg/m 2  days 1-5) during part 2 of consolidation and delayed intensification. Prospective interim monitoring rules for efficacy and futility were included where futility would be determined for a one-sided P-value ≥0.7664. The study was stopped for futility as the interim monitoring boundary was crossed [hazard ratio 0.606 (95% confidence interval: 0.297 - 1.237)] and the very high-risk arm of AALL1131 was closed in February 2017. Using data current as of December 31, 2017, 4-year disease-free survival rates were 85.5±6.8% (control arm) versus 72.3±6.3% (experimental arm 1) (P-value = 0.76). There were no significant differences in grade 3/4 adverse events between the two arms. Substitution of this therapy for very high-risk B-cell acute lymphoblastic leukemia patients on the Children's Oncology Group AALL1131 trial (NCT02883049) randomized to cyclophosphamide/etoposide during part 2 of consolidation and delayed intensification did not improve disease-free survival.",2019,There were no significant differences in grade 3/4 adverse events between the two arms.,"['Patients 1-30 years of age with newly diagnosed very high-risk B-cell acute lymphoblastic leukemia', 'pediatric B-cell acute lymphoblastic leukemia', 'patients with pediatric acute lymphoblastic leukemia', 'very high-risk B-cell acute lymphoblastic leukemia patients', 'children, adolescents, and young adults with very high-risk B-cell acute lymphoblastic leukemia']","['modern chemotherapy', 'cyclophosphamide/etoposide', 'cyclophosphamide/cytarabine/mercaptopurine with cyclophosphamide/etoposide', 'cyclophosphamide', 'modified Berlin-Frankfurt-Münster regimen (control arm']","['survival', '4-year disease-free survival rates', 'grade 3/4 adverse events', 'disease-free survival', '4-year disease-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1292769', 'cui_str': 'c-ALL'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.044324,There were no significant differences in grade 3/4 adverse events between the two arms.,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Burke', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Wisconsin, Milwaukee, WI mmburke@mcw.edu.""}, {'ForeName': 'Wanda L', 'Initials': 'WL', 'LastName': 'Salzer', 'Affiliation': 'U.S. Army Medical Research and Materiel Command, Fort Detrick, MD.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine and Public Health & Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine and Public Health & Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Gore', 'Affiliation': ""Department of Pediatrics, Center for Cancer and Blood Disorders, Children's Hospital Colorado and The University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Hilden', 'Affiliation': ""Department of Pediatrics, Center for Cancer and Blood Disorders, Children's Hospital Colorado and The University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Larsen', 'Affiliation': ""Department of Pediatrics, Maine Children's Cancer Program, Scarborough, ME.""}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Rabin', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Zweidler-McKay', 'Affiliation': 'ImmunoGen, Inc, Waltham, MA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': 'Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Wood', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'Department of Pathology, The Ohio State University School of Medicine, Columbus, OH.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, AL.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Winick', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Department of Pediatrics, Perlmutter Cancer Center, New York University Langone Health, New York, NY.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Department of Pediatrics, Perlmutter Cancer Center, New York University Langone Health, New York, NY.'}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California at San Francisco, CA.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.""}]",Haematologica,['10.3324/haematol.2018.204545']
3588,32188697,Effect of Low-Sodium versus Conventional Sodium Dialysate on Left Ventricular Mass in Home and Self-Care Satellite Facility Hemodialysis Patients: A Randomized Clinical Trial.,"BACKGROUND


Fluid overload in patients undergoing hemodialysis contributes to cardiovascular morbidity and mortality. There is a global trend to lower dialysate sodium with the goal of reducing fluid overload.
METHODS


To investigate whether lower dialysate sodium during hemodialysis reduces left ventricular mass, we conducted a randomized trial in which patients received either low-sodium dialysate (135 mM) or conventional dialysate (140 mM) for 12 months. We included participants who were aged >18 years old, had a predialysis serum sodium ≥135 mM, and were receiving hemodialysis at home or a self-care satellite facility. Exclusion criteria included hemodialysis frequency >3.5 times per week and use of sodium profiling or hemodiafiltration. The main outcome was left ventricular mass index by cardiac magnetic resonance imaging.
RESULTS


The 99 participants had a median age of 51 years old; 67 were men, 31 had diabetes mellitus, and 59 had left ventricular hypertrophy. Over 12 months of follow-up, relative to control, a dialysate sodium concentration of 135 mmol/L did not change the left ventricular mass index, despite significant reductions at 6 and 12 months in interdialytic weight gain, in extracellular fluid volume, and in plasma B-type natriuretic peptide concentration (ratio of intervention to control). The intervention increased intradialytic hypotension (odds ratio [OR], 7.5; 95% confidence interval [95% CI], 1.1 to 49.8 at 6 months and OR, 3.6; 95% CI, 0.5 to 28.8 at 12 months). Five participants in the intervention arm could not complete the trial because of hypotension. We found no effect on health-related quality of life measures, perceived thirst or xerostomia, or dietary sodium intake.
CONCLUSIONS


Dialysate sodium of 135 mmol/L did not reduce left ventricular mass relative to control, despite improving fluid status.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


The Australian New Zealand Clinical Trials Registry, ACTRN12611000975998.",2020,"The intervention increased intradialytic hypotension (odds ratio [OR], 7.5; 95% confidence interval [95% CI], 1.1 to 49.8 at 6 months and OR, 3.6; 95% CI, 0.5 to 28.8 at 12 months).","['hemodialysis reduces left ventricular mass', 'patients undergoing hemodialysis', 'Home and Self-Care Satellite Facility Hemodialysis Patients', 'participants who were aged >18 years old, had a predialysis serum sodium ≥135 mM, and were receiving hemodialysis at home or a self-care satellite facility', '99 participants had a median age of 51 years old; 67 were men, 31 had diabetes mellitus, and 59 had left ventricular hypertrophy']","['sodium profiling or hemodiafiltration', 'low-sodium dialysate (135 mM) or conventional dialysate', 'Low-Sodium versus Conventional Sodium Dialysate', 'dialysate sodium']","['left ventricular mass index by cardiac magnetic resonance imaging', 'Left Ventricular Mass', 'health-related quality of life measures, perceived thirst or xerostomia, or dietary sodium intake', 'intradialytic hypotension', 'interdialytic weight gain, in extracellular fluid volume, and in plasma B-type natriuretic peptide concentration']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0332221', 'cui_str': 'Satellite (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0149721', 'cui_str': 'Left Ventricular Hypertrophy'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake (observable entity)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0015349', 'cui_str': 'Extracellular Fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.202177,"The intervention increased intradialytic hypotension (odds ratio [OR], 7.5; 95% confidence interval [95% CI], 1.1 to 49.8 at 6 months and OR, 3.6; 95% CI, 0.5 to 28.8 at 12 months).","[{'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Marshall', 'Affiliation': 'Department of Renal Medicine, Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand; markrogermarshall@icloud.com.'}, {'ForeName': 'Alain C', 'Initials': 'AC', 'LastName': 'Vandal', 'Affiliation': 'Department of Statistics, Faculty of Science, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': 'Department of Renal Medicine, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Ruvin S', 'Initials': 'RS', 'LastName': 'Gabriel', 'Affiliation': 'Department of Cardiology, Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Imad A', 'Initials': 'IA', 'LastName': 'Haloob', 'Affiliation': 'Department of Renal Medicine, Bathurst Base Hospital, New South Wales, Bathurst, Australia.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Hood', 'Affiliation': 'Department of Renal Medicine, Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Irvine', 'Affiliation': 'Department of Nephrology, Christchurch Hospital, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Matheson', 'Affiliation': 'Department of Nephrology, Wellington Hospital, Capital & Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'David O R', 'Initials': 'DOR', 'LastName': 'McGregor', 'Affiliation': 'Department of Nephrology, Christchurch Hospital, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Kannaiyan S', 'Initials': 'KS', 'LastName': 'Rabindranath', 'Affiliation': 'Department of Nephrology, Waikato Hospital, Waikato District Health Board, Hamilton, New Zealand.'}, {'ForeName': 'John B W', 'Initials': 'JBW', 'LastName': 'Schollum', 'Affiliation': 'Nephrology Service, Dunedin Hospital, Southern District Health Board, Dunedin, New Zealand.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Semple', 'Affiliation': 'Department of Renal Medicine, Auckland City Hospital, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Zhengxiu', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Middlemore Clinical Trials, Auckland, New Zealand; and.'}, {'ForeName': 'Tian Min', 'Initials': 'TM', 'LastName': 'Ma', 'Affiliation': 'Department of Renal Medicine, Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand; markrogermarshall@icloud.com.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Sisk', 'Affiliation': 'Division of Informatics, Imaging & Data Sciences, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Dunlop', 'Affiliation': 'Department of Renal Medicine, Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019090877']
3589,32156544,"Efficacy and safety of intravenous lidocaine in propofol-based sedation for ERCP procedures: a prospective, randomized, double-blinded, controlled trial.","BACKGROUND AND AIMS


Propofol-based sedation is widely used in ERCP procedures, but adverse respiratory or cardiovascular events commonly occur. Intravenous injection of lidocaine has an analgesic effect and can reduce the requirements of fentanyl and propofol during abdominal surgery. The objective of this study was to assess the efficacy and safety of intravenous lidocaine on propofol requirements during ERCP procedures.
METHODS


Forty-eight patients scheduled for ERCP were randomly divided into 2 groups, the lidocaine group and the control group. All patients received .02 mg/kg midazolam and .1 μg/kg sufentanil intravenously as premedication. A bolus of propofol was applied for induction of sedation, and perfusion of propofol was applied for maintenance. Patients in the lidocaine group received a bolus of 1.5 mg/kg lidocaine intravenously followed by continuous infusion of 2 mg/kg/h, whereas the control group received the same volumes of saline solution. The primary outcome was the propofol requirement during ERCP.
RESULTS


Compared with the control group, propofol requirements were reduced by 33.8% in the lidocaine group (212.0 ± 118.2 mg vs 320.0 ± 189.6 mg, P = .023). Involuntary movement was less common in the lidocaine group than in the control group (12.5% vs 41.7%, P = .049). In the lidocaine group, postprocedure pain and fatigue, as measured by the visual analog scale, were significantly reduced (0 [range, 0-4] vs 3 [range, 0-5], P = .005; 2 [range, 0-4] vs 5 [range, 2-8], P < .001).The incidence of oxygen desaturation, hypotension, and bradycardia tended to be lower in the lidocaine group.
CONCLUSIONS


Intravenous lidocaine can significantly decrease propofol requirements during ERCP, with higher sedation quality and endoscopist satisfaction. (Clinical trial registration number: NCT03996577.).",2020,"Involuntary movement was less common in the lidocaine group than in the control group (12.5% vs 41.7%, p=0.049).",['Forty-eight patients scheduled for ERCP'],"['midazolam', 'propofol', 'propofol-based sedation', 'sufentanil', 'saline solution', 'lidocaine']","['propofol requirement during ERCP', 'Efficacy and safety', 'oxygen desaturation, hypotension, and bradycardia', 'efficacy and safety', 'Involuntary movement', 'sedation quality and endoscopist satisfaction', 'propofol requirements', 'postprocedure pain and fatigue']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0427086', 'cui_str': 'Involuntary Movements'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",48.0,0.0527241,"Involuntary movement was less common in the lidocaine group than in the control group (12.5% vs 41.7%, p=0.049).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China; Department of Anesthesiology, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ji', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Yan-Qing', 'Initials': 'YQ', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China; Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China; Robot Engineering Laboratory for Precise Diagnosis and Therapy of GI Tumor, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.02.050']
3590,31187344,Interventions to Reduce Unhealthy Alcohol Use among Primary Care Patients with HIV: the Health and Motivation Randomized Clinical Trial.,"BACKGROUND


Unhealthy alcohol use has adverse effects on HIV treatment. Screening, brief intervention, and referral to treatment (SBIRT) has some evidence of efficacy but may not be sufficient for those with low motivation or comorbid substance use.
OBJECTIVE


To examine the effectiveness of motivational interviewing (MI) and emailed feedback (EF) among primary care HIV-positive patients, compared with treatment as usual care (UC) only, which included SBIRT.
DESIGN


Randomized clinical trial.
PARTICIPANTS


Six hundred fourteen adult HIV-positive patients in Kaiser Permanente Northern California who reported prior-year unhealthy alcohol use.
INTERVENTION


Participants were randomized to either three sessions of MI (one in person and two by phone), information regarding alcohol risks via EF through a patient portal, or UC alone. MI and EF participants who reported unhealthy alcohol use at 6 months were offered additional MI and EF treatment, respectively.
MAIN MEASURES


Participant-reported unhealthy alcohol use (defined as ≥ 4/≥ 5 drinks per day for women/men), alcohol problems at 12 months, based on blinded telephone interviews. Secondary outcomes included drug use and antiretroviral (ART) adherence.
KEY RESULTS


At 12 months, there were no overall group differences, but in all three arms, there were declines in unhealthy alcohol use and alcohol-related problems (p < 0.001). Participants reporting low motivation to reduce drinking at baseline were less likely to report unhealthy alcohol use if they received MI vs. EF and UC (p = 0.013). At 6 months, reported illegal drug use/misuse of prescription drugs other than marijuana was lower in the MI arm than EF or UC (p = 0.012). There were no differences in ART adherence between groups.
CONCLUSIONS


In a randomized trial of HIV-positive patients using two behavioral interventions compared with SBIRT alone, participants in all three conditions reduced unhealthy alcohol use. MI may provide added benefit for patients with low motivation or who report illegal drug use/misuse of prescription drugs.
TRIAL REGISTRATION


NCT01671501 ( ClinicalTrials.gov ).",2019,"At 6 months, reported illegal drug use/misuse of prescription drugs other than marijuana was lower in the MI arm than EF or UC (p = 0.012).","['Six hundred fourteen adult HIV-positive patients in Kaiser Permanente Northern California who reported prior-year unhealthy alcohol use', 'HIV-positive patients using two', 'primary care HIV-positive patients, compared with treatment as usual care (UC) only, which included SBIRT', 'patients with low motivation or who report illegal drug use/misuse of prescription drugs', 'Primary Care Patients with HIV']","['MI (one in person and two by phone), information regarding alcohol risks via EF through a patient portal, or UC alone', 'motivational interviewing (MI) and emailed feedback (EF', 'behavioral interventions', 'SBIRT alone']","['illegal drug use/misuse of prescription drugs', 'ART adherence', 'unhealthy alcohol use and alcohol-related problems', 'drug use and antiretroviral (ART) adherence']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0558078', 'cui_str': 'Low motivation (finding)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}]",614.0,0.193652,"At 6 months, reported illegal drug use/misuse of prescription drugs other than marijuana was lower in the MI arm than EF or UC (p = 0.012).","[{'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, Box 0984, San Francisco, 401 Parnassus Avenue, San Francisco, CA, 94143, USA. derek.satre@ucsf.edu.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Leibowitz', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Leyden', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Catz', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, 2450 48th Street, Suite 2600, Sacramento, CA, 95817, USA.'}, {'ForeName': 'C Bradley', 'Initials': 'CB', 'LastName': 'Hare', 'Affiliation': 'Kaiser Permanente San Francisco Medical Center, 2238 Geary Blvd, San Francisco, CA, 94115, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Jang', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Lam', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Constance M', 'Initials': 'CM', 'LastName': 'Weisner', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, Box 0984, San Francisco, 401 Parnassus Avenue, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Sterling', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horberg', 'Affiliation': 'Mid-Atlantic Permanente Research Institute, Kaiser Permanente Mid-Atlantic States, 2101 East Jefferson, Rockville, MD, 20852, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Volberding', 'Affiliation': 'AIDS Research Institute, University of California, San Francisco, CA, 94158, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Silverberg', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05065-9']
3591,31544806,Responses to growth hormone (GH) therapy in short children with normal GH secretion and no bone age delay: an analysis of potential factors affecting their response to rhGH therapy. A controlled study.,"BACKGROUND


Variability still exist about the growth response to growth hormone (GH) therapy in children with idiopathic short stature (ISS). We describe the growth response to rhGH therapy for >2 years in 20 prepubertal children with idiopathic short stature (ISS) and 18 children with GH deficiency (GHD) and compared them with 15 children with ISS who did not receive rhGH therapy.
PATIENTS AND METHODS


Our study included 35 prepubertal and peripubertal (Tanner 1 and 2) children with short stature (Ht-SDS <-2) and/or Ht-SDS >1SD below their mid parental height SD (MP-Ht-SDS) with slow growth velocity (<-1 SD), with normal peak GH response to provocation tests (15.5±6.5 ng/dl), normal IGF-I SDS (-0.9±0.6), and no bone age delay (± 1 year from chronological age) (ISS). 20 children were treated for 2.5±1.5 years with rhGH 0.05 mg/kg/day and 15 children were not treated with rhGH. 18 children with diagnosis of GHD, diagnosed in the same period, receiving rhGH therapy served as controls. We assessed the linear growth and IGF-I levels of all children for an average of 2 years.
RESULTS


Children with ISS on rhGH therapy had a height gain of 0.77 SD in 2 years versus 1.05 SD in GHD children, with significant increase in IGF-I and normal progression of bone age and puberty. Children with ISS who did not receive rhGH had no gain in the changes of Ht-SDS inspite of normal progression of bone age and puberty. The difference between children Ht-SDS and mid-parental height SDS (MP-Ht-SDS) changed significantly from -1.1±3 to -0.3±0.5 in the ISS group and from -1.35±0.5 to -0.3±0.25 in the GHD group, after an average of 2 years of treatment. In the treated ISS group, the Ht-SDS gain was correlated positively with the duration of rhGH therapy (r = 0.82, p<0.0001), negatively with the age at the start of treatment (r = -0.544, p = 0.01), and positively with the bone age (r =-0.44, p = 0.04).
DISCUSSION


The Ht-SDS of children with ISS on rhGH treatment closely approached their MP-Ht-SDS after 2 years of rhGH therapy while those who did not receive rhGH kept the same distance from their MP-Ht-SDS after 2 years. Analysis of possible factors affecting linear growth in children with ISS on rhGH therapy showed that children below 9 years with Ht-SDS <-2.5 SD and those with Ht-SDS >1SD below MP-Ht-SDS grew better on rhGH therapy compared to older children and those with Ht-SDS >-2.5 and were less than 1SD from their MP-HT-SD. Higher doses of rhGH (to keep IGF-I in high normal levels) and longer duration of therapy improved the Ht-SDS gain of these children.
CONCLUSION


We report significant gain in Ht-SDS in prepubertal children with ISS on rhGH therapy and better response in younger children and in those with Ht-SDS > 1 SD below their MP-Ht-SDS.",2019,The Ht-SDS of children with ISS on rhGH treatment closely approached their MP-Ht-SDS after 2 years of rhGH therapy while those who did not receive rhGH kept the same distance from their MP-Ht-SDS after 2 years.,"['20 children', 'Children with ISS who did not receive', '35 prepubertal and peripubertal (Tanner 1 and 2) children with short stature (Ht-SDS <-2', 'prepubertal children with ISS', 'children with ISS', '18 children with diagnosis of GHD, diagnosed in the same period, receiving rhGH therapy served as controls', 'short children with normal GH secretion and no bone age delay', 'children with idiopathic short stature (ISS', '20 prepubertal children with idiopathic short stature (ISS) and 18 children with GH deficiency (GHD) and compared them with 15 children with ISS who did not receive rhGH therapy']","['rhGH', 'growth hormone (GH) therapy', 'and/or Ht-SDS', 'rhGH therapy']","['duration of rhGH therapy', 'Ht-SDS gain', 'height gain', 'children Ht-SDS and mid-parental height SDS (MP-Ht-SDS', 'IGF', 'linear growth and IGF-I levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0335730', 'cui_str': 'Tanner (occupation)'}, {'cui': 'C0013336', 'cui_str': 'Nanism'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0429620', 'cui_str': 'Bone age'}, {'cui': 'C1740819', 'cui_str': 'Idiopathic short stature'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",20.0,0.0238006,The Ht-SDS of children with ISS on rhGH treatment closely approached their MP-Ht-SDS after 2 years of rhGH therapy while those who did not receive rhGH kept the same distance from their MP-Ht-SDS after 2 years.,"[{'ForeName': 'Ashraf T', 'Initials': 'AT', 'LastName': 'Soliman', 'Affiliation': 'Department of Pediatrics, University of Alexandria, Alexandria, Egypt. atsoliman@yahoo.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elawwa', 'Affiliation': ''}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Itani', 'Affiliation': ''}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Jour', 'Affiliation': ''}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'De Sanctis', 'Affiliation': ''}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v90i8-S.8506']
3592,31838259,Wood stove interventions and child respiratory infections in rural communities: KidsAir rationale and methods.,"BACKGROUND


Acute lower respiratory tract infections (LRTIs) account for >27% of all hospitalizations among US children under five years of age. Residential burning of biomass for heat leads to elevated indoor levels of fine particulate matter (PM 2.5 ) that often exceed current health based air quality standards. This is concerning as PM 2.5  exposure is associated with many adverse health outcomes, including a greater than three-fold increased risk of LRTIs. Evidence-based efforts are warranted in rural and American Indian/Alaska Native (AI/AN) communities in the US that suffer from elevated rates of childhood LRTI and commonly use wood for residential heating.
DESIGN


In three rural and underserved settings, we conducted a three-arm randomized controlled, post-only intervention trial in wood stove homes with children less than five years old. Education and household training on best-burn practices were introduced as one intervention arm (Tx1). This intervention was evaluated against an indoor air filtration unit arm (Tx2), as well as a control arm (Tx3). The primary outcome was LRTI incidence among children under five years of age.
DISCUSSION


To date, exposure reduction strategies in wood stove homes have been either inconsistently effective or include factors that limit widespread dissemination and continued compliance in rural and economically disadvantaged populations. As part of the ""KidsAIR"" study described herein, the overall hypothesis was that a low-cost, educational intervention targeting indoor wood smoke PM 2.5  exposures would be a sustainable approach for reducing children's risk of LRTI in rural and AI/AN communities.",2020,Residential burning of biomass for heat leads to elevated indoor levels of fine particulate matter (PM 2.5 ) that often exceed current health based air quality standards.,"['wood stove homes with children less than five years old', 'rural communities', 'In three rural and underserved settings']","['Education and household training', 'Wood stove interventions']",['LRTI incidence among children under five years of age'],"[{'cui': 'C1268550', 'cui_str': 'Wood stove'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1268550', 'cui_str': 'Wood stove'}]","[{'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",,0.0646851,Residential burning of biomass for heat leads to elevated indoor levels of fine particulate matter (PM 2.5 ) that often exceed current health based air quality standards.,"[{'ForeName': 'Curtis W', 'Initials': 'CW', 'LastName': 'Noonan', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA. Electronic address: curtis.noonan@umontana.edu.'}, {'ForeName': 'Erin O', 'Initials': 'EO', 'LastName': 'Semmens', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA.'}, {'ForeName': 'Desirae', 'Initials': 'D', 'LastName': 'Ware', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA.'}, {'ForeName': 'Bert B', 'Initials': 'BB', 'LastName': 'Boyer', 'Affiliation': 'Center for Alaska Native Health Research, University of Alaska Fairbanks, AK, USA; Oregon Health Science University, Portland, OR, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Erdei', 'Affiliation': 'Community Environmental Health Program, University of New Mexico College of Pharmacy, Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Scarlett E', 'Initials': 'SE', 'LastName': 'Hopkins', 'Affiliation': 'Center for Alaska Native Health Research, University of Alaska Fairbanks, AK, USA; Oregon Health Science University, Portland, OR, USA.'}, {'ForeName': 'Johnnye', 'Initials': 'J', 'LastName': 'Lewis', 'Affiliation': 'Community Environmental Health Program, University of New Mexico College of Pharmacy, Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Tony J', 'Initials': 'TJ', 'LastName': 'Ward', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105909']
3593,31430366,Intervention planning for Antibiotic Review Kit (ARK): a digital and behavioural intervention to safely review and reduce antibiotic prescriptions in acute and general medicine.,"BACKGROUND


Hospital antimicrobial stewardship strategies, such as 'Start Smart, Then Focus' in the UK, balance the need for prompt, effective antibiotic treatment with the need to limit antibiotic overuse using 'review and revise'. However, only a minority of review decisions are to stop antibiotics. Research suggests that this is due to both behavioural and organizational factors.
OBJECTIVES


To develop and optimize the Antibiotic Review Kit (ARK) intervention. ARK is a complex digital, organizational and behavioural intervention that supports implementation of 'review and revise' to help healthcare professionals safely stop unnecessary antibiotics.
METHODS


A theory-, evidence- and person-based approach was used to develop and optimize ARK and its implementation. This was done through iterative stakeholder consultation and in-depth qualitative research with doctors, nurses and pharmacists in UK hospitals. Barriers to and facilitators of the intervention and its implementation, and ways to address them, were identified and then used to inform the intervention's development.
RESULTS


A key barrier to stopping antibiotics was reportedly a lack of information about the original prescriber's rationale for and their degree of certainty about the need for antibiotics. An integral component of ARK was the development and optimization of a Decision Aid and its implementation to increase transparency around initial prescribing decisions.
CONCLUSIONS


The key output of this research is a digital and behavioural intervention targeting important barriers to stopping antibiotics at review (see http://bsac-vle.com/ark-the-antibiotic-review-kit/ and http://antibioticreviewkit.org.uk/). ARK will be evaluated in a feasibility study and, if successful, a stepped-wedge cluster-randomized controlled trial at acute hospitals across the NHS.",2019,"An integral component of ARK was the development and optimization of a Decision Aid and its implementation to increase transparency around initial prescribing decisions.
",['acute and general medicine'],['Antibiotic Review Kit (ARK) intervention'],[],"[{'cui': 'C0086343', 'cui_str': 'General Practice'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1690540', 'cui_str': 'Kit'}]",[],,0.0621841,"An integral component of ARK was the development and optimization of a Decision Aid and its implementation to increase transparency around initial prescribing decisions.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Santillo', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sivyer', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Krusche', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mowbray', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Jones', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'T E A', 'Initials': 'TEA', 'LastName': 'Peto', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Llewelyn', 'Affiliation': 'Brighton and Sussex Medical School, University of Sussex, Falmer, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz333']
3594,31352122,Higher striatal D2-receptor availability in aerobically fit older adults but non-selective intervention effects after aerobic versus resistance training.,"There is much evidence that dopamine is vital for cognitive functioning in aging. Here we tested the hypothesis that aerobic exercise and fitness influence dopaminergic neurotransmission in the striatum, and in turn performance on offline working-memory updating tasks. Dopaminergic neurotransmission was measured by positron emission tomography (PET) and the non-displacable binding potential (BP ND ) of [ 11 C]raclopride, i.e. dopamine (DA) D2-receptor (D2R) availability. Fifty-four sedentary older adults underwent a six-months exercise intervention, performing either aerobic exercise or stretching, toning, and resistance active control training. At baseline, higher aerobic fitness levels (VO 2 peak ) were associated with higher BP ND  in the striatum, providing evidence of a link between an objective measure of aerobic fitness and D2R in older adults. BP ND  decreased substantially over the intervention in both groups but the intervention effects were non-selective with respect to exercise group. The decrease was several times larger than any previously estimated annual decline in D2R, potentially due to increased endogenous DA. Working-memory was unrelated to D2R both at baseline and following the intervention. To conclude, we provide partial evidence for a link between physical exercise and DA. Utilizing a PET protocol able to disentangle both D2R and DA levels could shed further light on whether, and how, aerobic exercise impacts the dopaminergic system in older adults.",2019,BP ND  decreased substantially over the intervention in both groups but the intervention effects were non-selective with respect to exercise group.,"['older adults', 'Fifty-four sedentary older adults']","['aerobic exercise', 'dopamine', 'six-months exercise intervention, performing either aerobic exercise or stretching, toning, and resistance active control training']","['Dopaminergic neurotransmission', 'aerobic fitness levels', 'BP ND']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0027793', 'cui_str': 'Neural Transmission'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",54.0,0.0411754,BP ND  decreased substantially over the intervention in both groups but the intervention effects were non-selective with respect to exercise group.,"[{'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Jonasson', 'Affiliation': 'Department of Integrative Medical Biology, Physiology, Umeå University, Umeå, Sweden; Umeå Center for Functional Brain Imaging, Umeå University, Umeå, Sweden. Electronic address: lars.jonasson@umu.se.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nyberg', 'Affiliation': 'Department of Integrative Medical Biology, Physiology, Umeå University, Umeå, Sweden; Umeå Center for Functional Brain Imaging, Umeå University, Umeå, Sweden; Department of Radiation Sciences, Umeå University, Umeå, Sweden. Electronic address: lars.nyberg@umu.se.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Axelsson', 'Affiliation': 'Umeå Center for Functional Brain Imaging, Umeå University, Umeå, Sweden; Department of Radiation Sciences, Umeå University, Umeå, Sweden. Electronic address: jan.axelsson@umu.se.'}, {'ForeName': 'Arthur F', 'Initials': 'AF', 'LastName': 'Kramer', 'Affiliation': 'Departments of Psychology and Mechanical and Industrial Engineering, Northeastern University, Boston, MA, USA; Beckman Institute, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL, USA. Electronic address: a.kramer@northeastern.edu.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Riklund', 'Affiliation': 'Umeå Center for Functional Brain Imaging, Umeå University, Umeå, Sweden; Department of Radiation Sciences, Umeå University, Umeå, Sweden. Electronic address: katrine.riklund@umu.se.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Boraxbekk', 'Affiliation': 'Umeå Center for Functional Brain Imaging, Umeå University, Umeå, Sweden; Center for Demographic and Aging Research, Umeå University, Umeå, Sweden; Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: cj@drcmr.dk.'}]",NeuroImage,['10.1016/j.neuroimage.2019.116044']
3595,31206305,Substantial Biomechanical Improvement by Extracorporeal Shockwave Therapy After Surgical Repair of Rodent Chronic Rotator Cuff Tears.,"BACKGROUND


Characteristics of chronic rotator cuff tears include continuous loss of tendon structure as well as tendon elasticity, followed by a high failure rate after surgical reconstruction. Several studies have already shown the beneficial effect of extracorporeal shockwave therapy (ESWT) on tissue regeneration in tendon pathologies.
HYPOTHESIS


ESWT improves biomechanical tendon properties as well as functional shoulder outcomes in chronic rotator cuff reconstruction in rodents.
STUDY DESIGN


Controlled laboratory study.
METHODS


After tendon detachment and 3 weeks of degeneration, a subsequent transosseous reattachment of the supraspinatus tendon was performed in 48 adult male Sprague-Dawley rats (n = 16 per group). Rodents were randomly assigned to 3 study groups: no ESWT/control group, intraoperative ESWT (IntraESWT), and intra- and postoperative ESWT (IntraPostESWT). Shoulder joint function, as determined by gait analysis, was assessed repeatedly during the observation period. Eight weeks after tendon reconstruction, the rats were euthanized, and biomechanical and gene expression analyses were performed.
RESULTS


Macroscopically, all repairs were intact at the time of euthanasia, with no ruptures detectable. Biomechanical analyses showed significantly improved load-to-failure testing results in both ESWT groups in comparison with the control group (control, 0.629; IntraESWT, 1.102; IntraPostESWT, 0.924; IntraESWT vs control,  P ≤ .001; IntraPostESWT vs control,  P ≤ .05). Furthermore, functional gait analyses showed a significant enhancement in intensity measurements for the IntraPostESWT group in comparison with the control group ( P ≤ .05). Gene expression analysis revealed no significant differences among the 3 groups.
CONCLUSION


Clearly improved biomechanical results were shown in the single-application and repetitive ESWT groups. Furthermore, functional evaluation showed significantly improved intensity measurements for the repetitive ESWT group.
CLINICAL RELEVANCE


This study underpins a new additional treatment possibility to prevent healing failure. Improved biomechanical stability and functionality may enable faster remobilization as well as an accelerated return to work and sports activities. Furthermore, as shockwave therapy is a noninvasive, easy-to-perform, cost-effective treatment tool with no undesired side effects, this study is of high clinical relevance in orthopaedic surgery. Based on these study results, a clinical study has already been initiated to clinically confirm the improved functionality by ESWT.",2019,"Biomechanical analyses showed significantly improved load-to-failure testing results in both ESWT groups in comparison with the control group (control, 0.629; IntraESWT, 1.102; IntraPostESWT, 0.924; IntraESWT vs control,  P ≤ .001; IntraPostESWT vs control,  P ≤ .05).","['48 adult male Sprague-Dawley rats (n = 16 per group', 'chronic rotator cuff reconstruction in rodents', 'Rodent Chronic Rotator Cuff Tears']","['Extracorporeal Shockwave Therapy', 'extracorporeal shockwave therapy (ESWT', 'shockwave therapy', 'no ESWT/control group, intraoperative ESWT (IntraESWT), and intra- and postoperative ESWT (IntraPostESWT']","['healing failure', 'intensity measurements', 'Shoulder joint function', 'biomechanical tendon properties', 'load-to-failure testing results']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0035804', 'cui_str': 'Rodentias'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0037009', 'cui_str': 'Glenohumeral Joint'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",48.0,0.0251012,"Biomechanical analyses showed significantly improved load-to-failure testing results in both ESWT groups in comparison with the control group (control, 0.629; IntraESWT, 1.102; IntraPostESWT, 0.924; IntraESWT vs control,  P ≤ .001; IntraPostESWT vs control,  P ≤ .05).","[{'ForeName': 'Xaver', 'Initials': 'X', 'LastName': 'Feichtinger', 'Affiliation': 'Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, Vienna, Austria.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Monforte', 'Affiliation': 'Austrian Cluster for Tissue Regeneration, Vienna, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Keibl', 'Affiliation': 'Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, Vienna, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hercher', 'Affiliation': 'Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, Vienna, Austria.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Schanda', 'Affiliation': 'Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, Vienna, Austria.'}, {'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Teuschl', 'Affiliation': 'Austrian Cluster for Tissue Regeneration, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Muschitz', 'Affiliation': 'Metabolic Bone Diseases Unit, St Vincent Hospital, Vienna, Austria.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Redl', 'Affiliation': 'Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fialka', 'Affiliation': 'AUVA Trauma Center Vienna-Meidling, Vienna, Austria.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Mittermayr', 'Affiliation': 'Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, Vienna, Austria.'}]",The American journal of sports medicine,['10.1177/0363546519854760']
3596,32068484,"International Phase III, Randomized, Double-Blind, Placebo and Active Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR.","PURPOSE


We assessed efficacy, safety and tolerability of vibegron, a novel, potent, highly selective β 3 -adrenoceptor agonist, administered 12 weeks at 75 mg once daily to patients with overactive bladder in an international phase III trial with placebo and active control.
MATERIALS AND METHODS


Adult patients with overactive bladder with 8.0 or more micturitions per day were randomized 5:5:4 to 75 mg vibegron, placebo or extended-release 4 mg tolterodine. Up to 25% of patients could have dry overactive bladder (less than 1.0 urge incontinence episode per day). Patients completed 7-day voiding diaries at baseline and weeks 2, 4, 8 and 12.
RESULTS


Of 1,518 randomized patients 90.4% completed the trial. At 12 weeks micturitions decreased by an adjusted mean of 1.8 episodes per day for vibegron vs 1.3 for placebo (p <0.001, co-primary end point) and 1.6 for tolterodine. Among incontinent patients urge incontinence episodes decreased by an adjusted mean 2.0 episodes per day for vibegron vs 1.4 for placebo (p <0.0001, co-primary end point) and 1.8 for tolterodine. Moreover, vibegron was statistically significantly superior to placebo for key secondary measures of number of urgency episodes, volume per micturition and proportion of incontinent patients with a 75% or greater reduction in urge incontinence episodes (all p <0.01). Among vibegron treated patients 1.7% discontinued treatment because of adverse events vs 1.1% for placebo and 3.3% for tolterodine. Incidence of hypertension was 1.7% for vibegron and for placebo.
CONCLUSIONS


Once daily 75 mg vibegron provided statistically significant reductions in micturitions, urgency episodes and urge incontinence, and increased the volume per micturition. Treatment was well tolerated, with a favorable safety profile.",2020,"CONCLUSIONS


Once-daily vibegron 75 mg provided statistically significant reductions in micturitions, urgency episodes, urge incontinence, and increased the volume per micturition.","['Adult patients with overactive bladder with ≥8.0 micturitions/day', 'Patients with Symptoms of Overactive Bladder', 'patients with overactive bladder in an international phase III trial with']","['vibegron 75 mg, placebo, or extended-release tolterodine 4 mg', 'Vibegron', 'placebo', 'placebo and active control', 'tolterodine', 'Placebo']","['efficacy, safety, and tolerability', 'number of urgency episodes, volume per micturition', 'Safety and Efficacy', '7-day voiding diaries', 'micturitions, urgency episodes, urge incontinence, and increased the volume per micturition', 'adverse events', 'urge-incontinence episodes', 'Incidence of hypertension', 'dry overactive bladder']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4279743', 'cui_str': 'vibegron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0150045', 'cui_str': 'Urinary Reflex Incontinence'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}]",1518.0,0.512834,"CONCLUSIONS


Once-daily vibegron 75 mg provided statistically significant reductions in micturitions, urgency episodes, urge incontinence, and increased the volume per micturition.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': 'Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Frankel', 'Affiliation': 'Seattle Urology Research Center, Seattle, Washington.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Varano', 'Affiliation': 'Clinical Research Consulting, Milford, Connecticut.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Shortino', 'Affiliation': 'Urovant Sciences, Irvine, California.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Jankowich', 'Affiliation': 'Urovant Sciences, Irvine, California.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Mudd', 'Affiliation': 'Urovant Sciences, Irvine, California.'}]",The Journal of urology,['10.1097/JU.0000000000000807']
3597,31760780,Associations between Self-Reported Daily Affect Ratings and Sleep Duration during the First Two Weeks of Antidepressant Therapy.,"Background : In the context of a randomized controlled trial evaluating the efficacy of augmenting fluoxetine treatment in young adults with major depressive disorder (MDD) using a modified repeated partial sleep deprivation protocol contrasting 2 weeks of restricted time in bed (i.e., 6 h TIB) to no time in bed restriction (i.e., 8 h TIB) the study examines whether sleep duration and the timing of repeated partial sleep deprivation predicts patient-reported affect ratings. Participants : Participants included 58 young adults with DSM-IV-diagnosed MDD. Methods : Daily ratings of affect and sleep were collected during the first 2 weeks of initiating fluoxetine treatment, yielding 630 person-days. Actigraphy monitoring was employed to assess compliance with time in bed condition. Results : Negative affect ratings and positivity ratios in the morning were more improved among participants assigned to the 6 h TIB condition compared to the 8 h TIB group. Participants whose bedtime was delayed by 2-h nightly demonstrated the most significant improvement in negative affect and positivity ratio during the first 2 weeks of fluoxetine therapy. Moreover, the trajectory of morning negative affect ratings in the first 2 weeks was predictive of remission after 4 weeks of fluoxetine therapy. Conclusions : These findings suggest that monitoring changes in daily affect may be a valuable marker of early treatment response in young adults with MDD.",2019,Negative affect ratings and positivity ratios in the morning were more improved among participants assigned to the 6 h TIB condition compared to the 8 h TIB group.,"['Participants included 58 young adults with DSM-IV-diagnosed MDD', 'young adults with major depressive disorder (MDD', 'Participants ', 'young adults with MDD']","['fluoxetine', ' ']","['Negative affect ratings and positivity ratios', 'negative affect and positivity ratio', 'Daily ratings of affect and sleep']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",58.0,0.0203169,Negative affect ratings and positivity ratios in the morning were more improved among participants assigned to the 6 h TIB condition compared to the 8 h TIB group.,"[{'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Huntley', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Swanson', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Giselle E', 'Initials': 'GE', 'LastName': 'Kolenic', 'Affiliation': ""Program on Women's Health Care Effectiveness Research, Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, USA.""}, {'ForeName': 'Holli', 'Initials': 'H', 'LastName': 'Bertram', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Mooney', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Dopp', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'J Todd', 'Initials': 'JT', 'LastName': 'Arnedt', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}]",Behavioral sleep medicine,['10.1080/15402002.2019.1695617']
3598,30978556,"Rationale and design of the randomized, controlled Early Valve Replacement Guided by Biomarkers of Left Ventricular Decompensation in Asymptomatic Patients with Severe Aortic Stenosis (EVOLVED) trial.","BACKGROUND


The optimal timing of aortic valve replacement in asymptomatic patients with aortic stenosis is uncertain. Replacement fibrosis, as assessed by midwall (nonischemic) late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR) imaging, is an irreversible marker of left ventricular decompensation in aortic stenosis. Once established, it progresses rapidly and is associated with poor long-term prognosis in a dose-dependent manner.
TRIAL DESIGN


The objective of this multicenter prospective randomized controlled trial is to determine whether early aortic valve replacement in asymptomatic patients with severe aortic stenosis can improve the adverse prognosis associated with midwall LGE. Patients will be screened for likelihood of having LGE with electrocardiography or high-sensitivity troponin I. Those at high risk will proceed to CMR imaging. Approximately 400 patients with midwall LGE will be randomized 1:1 to early valve replacement or routine care. Those who do not exhibit midwall LGE will continue with routine care and be randomized to a study registry or no further follow-up. Follow-up will be annual for approximately 3 years until the number of required outcome events is achieved. The primary endpoint is a composite of all-cause mortality and unplanned aortic stenosis-related hospitalization. The expected event rate is 25.0% in the routine care arm and 13.4% in the early intervention arm over the first 2 years; 88 observed primary outcome events will give 90% power at 5% significance level. Key secondary endpoints include all-cause mortality, sudden cardiac death, stroke, and symptomatic status.
CONCLUSION


The EVOLVED trial is the first multicenter randomized controlled trial to compare early aortic valve replacement to routine care in asymptomatic patients with severe aortic stenosis and midwall LGE.",2019,The expected event rate is 25.0% in the routine care arm and 13.4% in the early intervention arm over the first 2 years; 88 observed primary outcome events will give 90% power at 5% significance level.,"['asymptomatic patients with severe aortic stenosis', 'aortic stenosis', 'asymptomatic patients with aortic stenosis', 'Patients will be screened for likelihood of having LGE with electrocardiography or high-sensitivity troponin I', 'Asymptomatic Patients with Severe Aortic Stenosis (EVOLVED) trial', 'asymptomatic patients with severe aortic stenosis and midwall LGE', 'Approximately 400 patients with midwall LGE']","['early aortic valve replacement', 'early valve replacement or routine care', 'aortic valve replacement']","['cause mortality, sudden cardiac death, stroke, and symptomatic status', 'composite of all-cause mortality and unplanned aortic stenosis-related hospitalization', 'event rate']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0085298', 'cui_str': 'Sudden Cardiac Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",400.0,0.140741,The expected event rate is 25.0% in the routine care arm and 13.4% in the early intervention arm over the first 2 years; 88 observed primary outcome events will give 90% power at 5% significance level.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Everett', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Tuck', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Semple', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Steff', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Harkess', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Treibel', 'Affiliation': 'Barts Health NHS Trust and University College London, London, United Kingdom.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Prasad', 'Affiliation': 'Imperial College London and Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, and the NIHR Leicester Biomedical Research Centre, Leicester, United Kingdom.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom. Electronic address: Marc.dweck@ed.ac.uk.'}]",American heart journal,['10.1016/j.ahj.2019.02.018']
3599,32061834,Online Couple-Based Meditation Intervention for Patients With Primary or Metastatic Brain Tumors and Their Partners: Results of a Pilot Randomized Controlled Trial.,"OBJECTIVES


Although patients with primary and metastatic brain tumors and their partners are at risk of experiencing high symptom burden, they are often excluded from psychosocial intervention studies. Thus, we sought to examine the feasibility and preliminary efficacy of a couple-based meditation (CBM) program targeting symptom and well-being outcomes.
METHODS


Couples completed baseline measures assessing symptom and well-being outcomes and were randomized to the CBM or a usual care control group. Couples in the CBM groups attended four weekly (60 minutes each) therapist-led sessions that were delivered via FaceTime (Apple Inc, Cupertino, CA). The CBM program focused on cultivating mindfulness, compassion, gratitude and purpose, and integrated emotional disclosure exercises. Both groups were reassessed six and 12 weeks after baseline.
RESULTS


We approached 60 eligible dyads, of which 37 (62%) consented, 35 (95%) were randomized, and 22 (63%) completed all assessments. Couples in the CBM group attended a mean of 3.33 sessions (SD 1.09). For patients, significant group differences in favor of the CBM group were found for cognitive (d = 1.05) and general disease symptoms (d = 0.93), and relationship well-being (d = 0.68) and compassion (d = 0.96). No significant group differences were revealed for partners.
CONCLUSION


It seems to be feasible, acceptable, and possibly efficacious to deliver a dyadic intervention via FaceTime to brain tumor couples. Although both patients and partners in the CBM group rated the intervention as beneficial, significant group differences with medium-to-large effect sizes were only found for patients.",2020,"For patients, significant group differences in favor of the CBM group were found for cognitive (d=1.05) and general disease symptoms (d=.93), and relationship well-being (d=.68) and compassion (d=.96).","['60 eligible dyads of which 37 (62%) consented and 35 (95%) were randomized and 22 (63%) completed all assessments', 'Patients with Primary or Metastatic Brain Tumors and their Partners', 'patients with primary and metastatic brain tumors (BT) and their partners']","['CBM or a usual care control (UC', 'CBM', 'couple-based meditation (CBM) program', 'Online Couple-Based Meditation Intervention']","['cultivating mindfulness, compassion, gratitude and purpose and integrated emotional disclosure exercises', 'general disease symptoms']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0006118', 'cui_str': 'Brain Tumors'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150277'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",60.0,0.0473221,"For patients, significant group differences in favor of the CBM group were found for cognitive (d=1.05) and general disease symptoms (d=.93), and relationship well-being (d=.68) and compassion (d=.96).","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Milbury', 'Affiliation': 'Department of Behavioral Science, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: kmilbury@mdanderson.org.'}, {'ForeName': 'Shiao-Pei', 'Initials': 'SP', 'LastName': 'Weathers', 'Affiliation': 'Department of Neuro-Oncology, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Sania', 'Initials': 'S', 'LastName': 'Durrani', 'Affiliation': 'Department of Behavioral Science, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Whisenant', 'Affiliation': 'Department of Symptom Research, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Lim', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Weinberg', 'Affiliation': 'Department of Neurosurgery, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Shelli R', 'Initials': 'SR', 'LastName': 'Kesler', 'Affiliation': 'Department of Oncology, Dell Medical School, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Palliative, Rehabilitation & Integrative Medicine, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative, Rehabilitation & Integrative Medicine, The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.02.004']
3600,30445488,Pair Matcher (PaM): fast model-based optimization of treatment/case-control matches.,"MOTIVATION


In clinical trials, individuals are matched using demographic criteria, paired and then randomly assigned to treatment and control groups to determine a drug's efficacy. A chief cause for the irreproducibility of results across pilot to Phase-III trials is population stratification bias caused by the uneven distribution of ancestries in the treatment and control groups.
RESULTS


Pair Matcher (PaM) addresses stratification bias by optimizing pairing assignments a priori and/or a posteriori to the trial using both genetic and demographic criteria. Using simulated and real datasets, we show that PaM identifies ideal and near-ideal pairs that are more genetically homogeneous than those identified based on competing methods, including the commonly used principal component analysis (PCA). Homogenizing the treatment (or case) and control groups can be expected to improve the accuracy and reproducibility of the trial or genetic study. PaM's ancestral inferences also allow characterizing responders and developing a precision medicine approach to treatment.
AVAILABILITY AND IMPLEMENTATION


PaM is freely available via Rhttps://github.com/eelhaik/PAM and a web-interface at http://elhaik-matcher.sheffield.ac.uk/ElhaikLab/.
SUPPLEMENTARY INFORMATION


Supplementary data are available at Bioinformatics online.",2019,Homogenising the treatment (or case) and control groups can be expected to improve the accuracy and reproducibility of the trial or genetic study.,[],[],['Motivation'],[],[],"[{'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.0321776,Homogenising the treatment (or case) and control groups can be expected to improve the accuracy and reproducibility of the trial or genetic study.,"[{'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Elhaik', 'Affiliation': 'Department of Animal and Plant Sciences, University of Sheffield, Sheffield UK, UK.'}, {'ForeName': 'Desmond M', 'Initials': 'DM', 'LastName': 'Ryan', 'Affiliation': 'Department of Animal and Plant Sciences, University of Sheffield, Sheffield UK, UK.'}]","Bioinformatics (Oxford, England)",['10.1093/bioinformatics/bty946']
3601,32147750,"Pharmacokinetics, pharmacodynamics, safety, tolerability, and mass balance of single and continuous intravenous infusion of SPT-07A in healthy volunteers.","PURPOSE


SPT-07A is an intravenous injection of (+)-2-borneol being developed for the treatment of acute ischemic stroke. This study aimed to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability, and mass balance of SPT-07A after sequentially administered single and multiple infusions of SPT-07A at 10 mg, 20 mg, or 40 mg.
METHODS


This phase I, double-blind, randomized, placebo-controlled, dose-escalation study was conducted in 36 Chinese healthy volunteers. Each cohort enrolled 12 eligible subjects, who were 9:3 randomized to receive SPT-07A or matching placebo during the two study occasions, that is, an initial single-dose occasion followed by a 7-day multiple-dose occasion with a dosing interval of 12 h. Pharmacokinetic, pharmacodynamic assessments regarding effects on the central nervous system (CNS) were performed pre-dose and several times post-dose. Safety and tolerability were evaluated throughout the study for each cohort.
RESULTS


Following single intravenous (i.v.) administration of 10 mg to 40 mg SPT-07A, the plasma SPT-07A concentration reached its peak by the end of infusion. Thereafter, the plasma concentration declined in a multiphase exponential manner with an average terminal elimination half-life of 3.85 to 8.93 h. The exposure parameters of SPT-07A increased dose proportionally. Steady state of SPT-07A was reached after 12-hourly i.v. administrations for 4 days with minimal accumulations. No significant difference of change-from-baseline was observed in the pharmacodynamic measurements between each of the three SPT-07A-treated groups and the placebo group. A total of 41 adverse events (AEs) were reported in 77.8% subjects at 10 mg (7/9), 20 mg (7/9), and 40 mg (7/9), respectively. The AE incidence in placebo group was also 77.8% (7/9). All AEs were mild or moderate in severity and self-limited. SPT-07A was mainly excreted in human urine in glucuronic acid conjugate forms. The total urine recovery rate approximated 84.69% of the administered dose.
CONCLUSIONS


SPT-07A was safe and well tolerated after single and multiple intravenous administrations of SPT-07A in the range of 10 mg to 40 mg. SPT-07A presented linear pharmacokinetics in human. Based on plasma exposure, the doses of 10-40 mg twice daily resulted in exposure levels comparable with those obtained at doses demonstrating potential efficacy on AIS animal models and were thus recommended as therapeutic exploratory doses in the phase II clinical trial.",2020,No significant difference of change-from-baseline was observed in the pharmacodynamic measurements between each of the three SPT-07A-treated groups and the placebo group.,"['36 Chinese healthy volunteers', 'healthy volunteers', 'Each cohort enrolled 12 eligible subjects', 'acute ischemic stroke']","['SPT-07A or matching placebo', 'placebo', 'SPT-07A']","['plasma SPT-07A concentration', 'Steady state of SPT-07A', 'pharmacodynamic measurements', 'total urine recovery rate', 'Pharmacokinetics, pharmacodynamics, safety, tolerability, and mass balance', 'plasma concentration', 'pharmacokinetics, pharmacodynamics, safety, tolerability, and mass balance of SPT-07A', 'Safety and tolerability', 'safe and well tolerated']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",12.0,0.11996,No significant difference of change-from-baseline was observed in the pharmacodynamic measurements between each of the three SPT-07A-treated groups and the placebo group.,"[{'ForeName': 'Weicong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China.""}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': ""Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China.""}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': ""Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China.""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China. connie_6096@126.com.""}]",European journal of clinical pharmacology,['10.1007/s00228-020-02851-x']
3602,31622733,Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC-Update from PACIFIC.,"INTRODUCTION


In the phase 3 PACIFIC study of patients with unresectable stage III NSCLC without progression after chemoradiotherapy, durvalumab demonstrated significant improvements versus placebo in the primary end points of progression-free survival (hazard ratio [HR] = 0.52, 95% confidence interval [CI]: 0.42-65, p < 0.0001) and overall survival (OS) (HR = 0.68, 95% CI: 0.53-0.87, p = 0.00251), with manageable safety and no detrimental effect on patient-reported outcomes. Here, we report 3-year OS rates for all patients randomized in the PACIFIC study.
METHODS


Patients, stratified by age, sex, and smoking history, were randomized (2:1) to receive durvalumab, 10 mg/kg intravenously every 2 weeks, or placebo for up to 12 months. OS was analyzed by using a stratified log-rank test in the intention-to-treat population. Medians and rates at 12, 24, and 36 months were estimated by the Kaplan-Meier method.
RESULTS


As of January 31, 2019, 48.2% of patients had died (44.1% and 56.5% in the durvalumab and placebo groups, respectively). The median duration of follow-up was 33.3 months. The updated OS remained consistent with that previously reported (stratified HR = 0.69 [95% CI: 0.55-0.86]); the median OS was not reached with durvalumab but was 29.1 months with placebo. The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively. All secondary outcomes examined showed improvements consistent with previous analyses.
CONCLUSIONS


Updated OS data from PACIFIC, including 3-year survival rates, demonstrate the long-term clinical benefit with durvalumab after chemoradiotherapy and further establish the PACIFIC regimen as the standard of care in this population.",2020,"The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively.","['patients with unresectable, Stage III NSCLC without progression after chemoradiotherapy (CRT', 'Stage III NSCLC - Update from PACIFIC', 'Patients, stratified by age, sex and smoking history']","['placebo', 'durvalumab 10 mg/kg intravenously every 2 weeks or placebo', 'durvalumab and placebo', 'durvalumab after chemoradiotherapy']","['3-year OS rates', 'died', 'progression-free survival', 'median OS', 'overall survival', '3-year survival rates', 'Median duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.557291,"The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively.","[{'ForeName': 'Jhanelle E', 'Initials': 'JE', 'LastName': 'Gray', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. Electronic address: Jhanelle.Gray@moffitt.org.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Villegas', 'Affiliation': 'Cancer Specialists of North Florida, Jacksonville, Florida.'}, {'ForeName': 'Davey', 'Initials': 'D', 'LastName': 'Daniel', 'Affiliation': 'Tennessee Oncology, Chattanooga, Tennessee; Sarah Cannon Research Institute, Nashville, Tennessee.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'University Hospital Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Murakami', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Westmead Hospital, Sydney, New South Wales, Australia; University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Kurata', 'Affiliation': 'Kansai Medical University Hospital, Hirakata, Japan.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Chiappori', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'University Hospital October 12, CiberOnc, Complutense University of Madrid, Madrid, Spain; National Cancer Research Center, Madrid, Spain.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'The University of Manchester and The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Vansteenkiste', 'Affiliation': 'University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, Tennessee.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wadsworth', 'Affiliation': 'AstraZeneca, Alderley Park, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Taboada', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Dennis', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpasa, Cerrahpasa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.10.002']
3603,30586751,Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis.,"BACKGROUND


The ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) previously reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not prevent postthrombotic syndrome (PTS) in patients with acute proximal deep vein thrombosis. In the current analysis, we examine the effect of PCDT in ATTRACT patients with iliofemoral deep vein thrombosis.
METHODS


Within a large multicenter randomized trial, 391 patients with acute deep vein thrombosis involving the iliac or common femoral veins were randomized to PCDT with anticoagulation versus anticoagulation alone (No-PCDT) and were followed for 24 months to compare short-term and long-term outcomes.
RESULTS


Between 6 and 24 months, there was no difference in the occurrence of PTS (Villalta scale ≥5 or ulcer: 49% PCDT versus 51% No-PCDT; risk ratio, 0.95; 95% CI, 0.78-1.15; P=0.59). PCDT led to reduced PTS severity as shown by lower mean Villalta and Venous Clinical Severity Scores ( P<0.01 for comparisons at 6, 12, 18, and 24 months), and fewer patients with moderate-or-severe PTS (Villalta scale ≥10 or ulcer: 18% versus 28%; risk ratio, 0.65; 95% CI, 0.45-0.94; P=0.021) or severe PTS (Villalta scale ≥15 or ulcer: 8.7% versus 15%; risk ratio, 0.57; 95% CI, 0.32-1.01; P=0.048; and Venous Clinical Severity Score ≥8: 6.6% versus 14%; risk ratio, 0.46; 95% CI, 0.24-0.87; P=0.013). From baseline, PCDT led to greater reduction in leg pain and swelling ( P<0.01 for comparisons at 10 and 30 days) and greater improvement in venous disease-specific quality of life (Venous Insufficiency Epidemiological and Economic Study Quality of Life unit difference 5.6 through 24 months, P=0.029), but no difference in generic quality of life ( P>0.2 for comparisons of SF-36 mental and physical component summary scores through 24 months). In patients having PCDT versus No-PCDT, major bleeding within 10 days occurred in 1.5% versus 0.5% ( P=0.32), and recurrent venous thromboembolism over 24 months was observed in 13% versus 9.2% ( P=0.21).
CONCLUSIONS


In patients with acute iliofemoral deep vein thrombosis, PCDT did not influence the occurrence of PTS or recurrent venous thromboembolism. However, PCDT significantly reduced early leg symptoms and, over 24 months, reduced PTS severity scores, reduced the proportion of patients who developed moderate-or-severe PTS, and resulted in greater improvement in venous disease-specific quality of life.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov . Unique identifier: NCT00790335.",2019,"From baseline, PCDT led to greater reduction in leg pain and swelling ( P<0.01 for comparisons at 10 and 30 days) and greater improvement in venous disease-specific quality of life (Venous Insufficiency Epidemiological and Economic Study Quality of Life unit difference 5.6 through 24 months, P=0.029), but no difference in generic quality of life ( P>0.2 for comparisons of SF-36 mental and physical component summary scores through 24 months).","['391 patients with acute deep vein thrombosis involving the iliac or common femoral veins', 'Acute Iliofemoral Deep Vein Thrombosis', 'patients with acute proximal deep vein thrombosis', 'patients with iliofemoral deep vein thrombosis']","['Endovascular Thrombus Removal', 'PCDT', 'pharmacomechanical catheter-directed thrombolysis (PCDT', 'Adjunctive Catheter-Directed Thrombolysis', 'PCDT with anticoagulation versus anticoagulation alone (No-PCDT']","['venous disease-specific quality of life (Venous Insufficiency Epidemiological and Economic Study Quality of Life', 'recurrent venous thromboembolism', 'leg pain and swelling', 'PTS severity', 'severe PTS', 'Venous Clinical Severity Score', 'PTS severity scores', 'occurrence of PTS (Villalta scale ≥5 or ulcer', 'generic quality of life', 'mean Villalta and Venous Clinical Severity Scores', 'major bleeding', 'early leg symptoms', 'occurrence of PTS or recurrent venous thromboembolism', 'venous disease-specific quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1275667', 'cui_str': 'Common femoral vein'}, {'cui': 'C0340714', 'cui_str': 'IFVT - Iliofemoral vein thrombosis'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}]","[{'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}]","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0042485', 'cui_str': 'Venous Insufficiency'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C4720900', 'cui_str': 'Villalta scale (assessment scale)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",391.0,0.1634,"From baseline, PCDT led to greater reduction in leg pain and swelling ( P<0.01 for comparisons at 10 and 30 days) and greater improvement in venous disease-specific quality of life (Venous Insufficiency Epidemiological and Economic Study Quality of Life unit difference 5.6 through 24 months, P=0.029), but no difference in generic quality of life ( P>0.2 for comparisons of SF-36 mental and physical component summary scores through 24 months).","[{'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Comerota', 'Affiliation': 'Inova Heart and Vascular Institute, Inova Alexandria Hospital, VA (A.J.C.).'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Kearon', 'Affiliation': 'Thrombosis and Atherosclerosis Research Institute (C.K.), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Chu-Shu', 'Initials': 'CS', 'LastName': 'Gu', 'Affiliation': 'Department of Oncology (C.-S.G., J.A.J.), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jim A', 'Initials': 'JA', 'LastName': 'Julian', 'Affiliation': 'Department of Oncology (C.-S.G., J.A.J.), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA (S.Z.G.).""}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Jewish General Hospital, Lady Davis Institute, Center for Clinical Epidemiology, Montreal, QC, Canada (S.R.K.).'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': 'Newton-Wellesley Hospital, and Harvard Medical School, Boston, MA (M.R.J.).'}, {'ForeName': 'Mahmood K', 'Initials': 'MK', 'LastName': 'Razavi', 'Affiliation': ""St. Joseph's Hospital, Orange, CA (M.K.R.).""}, {'ForeName': 'Andrei L', 'Initials': 'AL', 'LastName': 'Kindzelski', 'Affiliation': 'National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD (A.L.K.).'}, {'ForeName': 'Riyaz', 'Initials': 'R', 'LastName': 'Bashir', 'Affiliation': 'Department of Medicine, Temple University Hospital, Philadelphia, PA (R.B.).'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Department of Radiology, Medical College of Wisconsin, Milwaukee (P.P.).'}, {'ForeName': 'Mel', 'Initials': 'M', 'LastName': 'Sharafuddin', 'Affiliation': 'Division of Vascular Surgery, University of Iowa, Iowa City (M.S.).'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sichlau', 'Affiliation': 'Vascular and Interventional Professionals LLC, Hinsdale, IL (M.J.S.).'}, {'ForeName': 'Wael E', 'Initials': 'WE', 'LastName': 'Saad', 'Affiliation': 'Department of Radiology, University of Michigan, Ann Arbor (W.E.S.).'}, {'ForeName': 'Zakaria', 'Initials': 'Z', 'LastName': 'Assi', 'Affiliation': 'Toledo Radiological Associates, Vascular & Interventional Radiology, OH (Z.A.).'}, {'ForeName': 'Lawrence V', 'Initials': 'LV', 'LastName': 'Hofmann', 'Affiliation': 'Department of Radiology, Stanford University, CA (L.V.H.).'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kennedy', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC (M.K.).'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Vedantham', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University in St. Louis, MO (S.V.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.118.037425']
3604,31385001,"A drug-drug interaction study to assess the potential effect of acid-reducing agent, lansoprazole, on quizartinib pharmacokinetics.","PURPOSE


Quizartinib, a potent, selective FMS-like tyrosine kinase 3 (FLT3) inhibitor, is currently in phase 3 development for patients with FLT3-internal tandem duplication-mutated acute myeloid leukemia (AML). Acid-reducing agents (ARAs; e.g., proton pump inhibitors) are frequently used during AML treatment. Since quizartinib demonstrates pH-dependent solubility, the effect of lansoprazole coadministration on pharmacokinetics (PK) of quizartinib tablet formulation was assessed.
METHODS


An open-label, parallel-group study randomized 64 healthy adults to single-dose quizartinib 30 mg alone (reference) or lansoprazole (60 mg once daily, days 1-5) + single-dose quizartinib 30 mg (day 5) (test). Plasma concentrations of quizartinib and its active metabolite, AC886, were measured to 504 h postdose; the effect of lansoprazole on quizartinib PK was assessed by analysis of variance.
RESULTS


Quizartinib geometric mean ratios (test/reference) and 90% confidence intervals for maximum observed plasma concentration (C max ), area under the concentration-time curve to last measurable drug concentration (AUC last ), and AUC to infinity were 86.11% (78.4%, 94.6%), 93.96% (79.6%, 110.9%), and 95.30% (80.2%, 113.3%), respectively. Comparisons showed a modest decrease in quizartinib absorption when co-administered with lansoprazole, with lower limits for C max  and AUC last  just below 80-125% limits. Treatment-emergent adverse events were mild or moderate; the most frequent in either treatment group were headache [quizartinib alone: (n = 3) 10%], upper respiratory tract infection [quizartinib alone: (n = 2) 6.7%; lansoprazole + quizartinib: (n = 3) 9.1%], and muscle tightness [quizartinib alone: (n = 2) 6.7%].
CONCLUSIONS


Concomitant lansoprazole had minimal effect on quizartinib PK as a formulated tablet, indicating that quizartinib can be administered with ARAs.",2019,"Comparisons showed a modest decrease in quizartinib absorption when co-administered with lansoprazole, with lower limits for C max  and AUC last  just below 80-125% limits.","['patients with FLT3-internal tandem duplication-mutated acute myeloid leukemia (AML', '64 healthy adults to']","['Acid-reducing agents (ARAs; e.g., proton pump inhibitors', 'lansoprazole\u2009+\u2009quizartinib', 'acid-reducing agent, lansoprazole', 'single-dose quizartinib 30\xa0mg alone (reference) or lansoprazole', 'lansoprazole']","['headache', 'quizartinib PK', 'plasma concentration (C max ), area under the concentration-time curve to last measurable drug concentration (AUC last ), and AUC to infinity', 'Quizartinib geometric mean ratios', 'Plasma concentrations of quizartinib and its active metabolite, AC886', 'upper respiratory tract infection', 'quizartinib absorption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332597', 'cui_str': 'Duplication (finding)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0376446', 'cui_str': 'Reductants'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C2980091', 'cui_str': 'AC220 compound'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C2980091', 'cui_str': 'AC220 compound'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}]",64.0,0.031407,"Comparisons showed a modest decrease in quizartinib absorption when co-administered with lansoprazole, with lower limits for C max  and AUC last  just below 80-125% limits.","[{'ForeName': 'Jianke', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Daiichi Sankyo, Inc., 10201 Wateridge Circle, Suite 240, San Diego, CA, 92121, USA. jiankelius@yahoo.com.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Trone', 'Affiliation': 'Daiichi Sankyo, Inc., 10201 Wateridge Circle, Suite 240, San Diego, CA, 92121, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Mendell', 'Affiliation': 'Daiichi Sankyo, Inc., Basking Ridge, NJ, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': ""O'Donnell"", 'Affiliation': 'Daiichi Sankyo, Inc., 10201 Wateridge Circle, Suite 240, San Diego, CA, 92121, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Cook', 'Affiliation': 'Daiichi Sankyo, Inc., 10201 Wateridge Circle, Suite 240, San Diego, CA, 92121, USA.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03915-1']
3605,32149427,Aromatic L-Amino Acid Decarboxylase Gene Therapy Enhances Levodopa Response in Parkinson's Disease.,"BACKGROUND


As Parkinson's disease progresses, levodopa treatment loses efficacy, partly through the loss of the endogenous dopamine-synthesizing enzyme L-amino acid decarboxylase (AADC). In the phase I PD-1101 study, putaminal administration of VY-AADC01, an investigational adeno-associated virus serotype-2 vector for delivery of the AADC gene in patients with advanced Parkinson's disease, was well tolerated, improved motor function, and reduced antiparkinsonian medication requirements.
OBJECTIVES


This substudy aimed to determine whether the timing and magnitude of motor response to intravenous levodopa changed in PD-1101 patients after VY-AADC01 administration.
METHODS


Participants received 2-hour threshold (0.6 mg/kg/h) and suprathreshold (1.2 mg/kg/h) levodopa infusions on each of 2 days, both before and approximately 6 months after VY-AADC01. Infusion order was randomized and double blinded. Unified Parkinson's Disease Rating Scale motor scores, finger-tapping speeds, and dyskinesia rating scores were assessed every 30 minutes for 1 hour before and ≥3 hours after start of levodopa infusion.
RESULTS


Of 15 PD-1101 patients, 13 participated in the substudy. Unified Parkinson's Disease Rating Scale motor score area under the curve responses to threshold and suprathreshold levodopa infusions increased by 168% and 67%, respectively, after VY-AADC01; finger-tapping speeds improved by 162% and 113%, and dyskinesia scores increased by 208% and 72%, respectively, after VY-AADC01. Adverse events (mild/moderate severity) were reported in 5 participants during levodopa infusions pre-VY-AADC01 and 2 participants post-VY-AADC01 administration.
CONCLUSIONS


VY-AADC01 improved motor responses to intravenous levodopa given under controlled conditions. These data and findings from the parent study support further clinical development of AADC gene therapy for people with Parkinson's disease. © 2020 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.",2020,"Unified Parkinson's Disease Rating Scale motor score area under the curve responses to threshold and suprathreshold levodopa infusions increased by 168% and 67%, respectively, after VY-AADC01; finger-tapping speeds improved by 162% and 113%, and dyskinesia scores increased by 208% and 72%, respectively, after VY-AADC01.","['2020', ""patients with advanced Parkinson's disease"", ""people with Parkinson's disease"", 'PD-1101 patients after VY-AADC01 administration', ""Parkinson's Disease"", 'Of 15 PD-1101 patients, 13 participated in the substudy']","['levodopa', 'Aromatic L-Amino Acid Decarboxylase Gene Therapy', 'levodopa infusions']","['dyskinesia scores', 'Adverse events', 'tapping speeds', 'Levodopa Response', ""Unified Parkinson's Disease Rating Scale motor score area under the curve responses to threshold and suprathreshold levodopa infusions"", 'motor responses', ""Unified Parkinson's Disease Rating Scale motor scores, finger-tapping speeds, and dyskinesia rating scores""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C1412028', 'cui_str': '5-Hydroxytryptophan Decarboxylase'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy (procedure)'}]","[{'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}]",,0.114359,"Unified Parkinson's Disease Rating Scale motor score area under the curve responses to threshold and suprathreshold levodopa infusions increased by 168% and 67%, respectively, after VY-AADC01; finger-tapping speeds improved by 162% and 113%, and dyskinesia scores increased by 208% and 72%, respectively, after VY-AADC01.","[{'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Nutt', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Curtze', 'Affiliation': 'Department of Biomechanics, University of Nebraska at Omaha, Omaha, Nebraska, USA.'}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Hiller', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Larson', 'Affiliation': 'Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Amber D', 'Initials': 'AD', 'LastName': 'Van Laar', 'Affiliation': 'Department of Neurology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'R Mark', 'Initials': 'RM', 'LastName': 'Richardson', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Marin E', 'Initials': 'ME', 'LastName': 'Thompson', 'Affiliation': 'Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sedkov', 'Affiliation': 'Voyager Therapeutics, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': 'Clinical Data Science GmbH, Basel, Switzerland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Ravina', 'Affiliation': 'Voyager Therapeutics, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Krystof S', 'Initials': 'KS', 'LastName': 'Bankiewicz', 'Affiliation': 'Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Chadwick W', 'Initials': 'CW', 'LastName': 'Christine', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.27993']
3606,31239021,Early Engagement is Associated with Better Weight Loss in Emerging Adults.,"Objectives:  Predictors of success among emerging adults (EAs; ages 18-25) within behavioral weight loss (BWL) trials are largely unknown. We examined whether early program engagement predicted overall engagement and weight loss in EAs.  Methods:  Data were pooled from 2 randomized controlled pilot trials in EAs. Participants (N = 99, 80% female, BMI = 33.7±5.1 kg/m²) received a 3-month BWL intervention. Weight was objectively assessed at 0 and 3 months; engagement was tracked weekly; retention was assessed at 3 months.  Results:  Greater engagement during the initial 4 weeks of treatment predicted greater weight loss (p = .001). Compared to those who did not engage in all 4 initial weeks, participants meeting this threshold experienced greater overall engagement (9.6 vs 4.2 weeks, p < .001), weight losses (intent-to-treat = -3.8% vs -1.3%, p = .004), and retention (78% vs 53%, p = .012).  Conclusions:  Early engagement in BWL is associated with better outcomes among EAs. Monitoring engagement in real-time during the initial 4 weeks of treatment may be necessary to intervene effectively. Early engagement did not vary by sex or race; future work should identify characteristics associated with poor early engagement.",2019,Results:  Greater engagement during the initial 4 weeks of treatment predicted greater weight loss (p = .001).,"['adults (EAs', ' ages 18-25) within behavioral weight loss (BWL) trials are largely unknown', 'Participants (N = 99, 80% female, BMI = 33.7±5.1 kg/m²']",[],"['weight loss', 'weight losses', 'overall engagement', 'Weight', 'Weight Loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.117057,Results:  Greater engagement during the initial 4 weeks of treatment predicted greater weight loss (p = .001).,"[{'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': 'Associate Professor, Virginia Commonwealth University School of Medicine, Department of Health Behavior and Policy, Richmond, VA;, Email: jessica.larose@vcuhealth.org.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Fava', 'Affiliation': 'Research Associate, The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI.'}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Lanoye', 'Affiliation': 'Postdoctoral Fellow, Virginia Commonwealth University School of Medicine, Department of Health Behavior and Policy, Richmond, VA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Caccavale', 'Affiliation': ""Postdoctoral Fellow, Children's Hospital of Richmond at Virginia Commonwealth University, Healthy Lifestyles Center, Richmond, VA.""}]",American journal of health behavior,['10.5993/AJHB.43.4.12']
3607,31182442,Evaluation of a prescription support-tool for chronic management of oral antithrombotic combinations in adults using clinical vignettes: protocol of a randomised controlled trial.,"INTRODUCTION


Improving the appropriateness of prescriptions of oral antithrombotic (AT) drugs, especially AT combinations, is crucial because these drugs are implicated in bleeding events. We developed a prescription support-tool synthesising guidelines on chronic management of oral AT combinations. Our main objective is to assess the impact of this tool on improving the prescription of oral ATs to comply with guidelines.
METHODS AND ANALYSIS


A randomised controlled trial will be conducted among French general practitioners and cardiologists involved in outpatient settings. Physicians will be invited to participate to an online survey by email via physician associations, social networks or word of mouth. They will be randomised to two arms: the experimental arm (access to the prescription support-tool) or the control arm (no prescription support-tool). Then, all participants will be presented three different clinical vignettes illustrating outpatient clinical situations and will be asked to propose prescriptions for each vignette (number of ATs, type, dosage and duration). A computer-generated randomisation scheme implemented in the online survey will be used to allocate physicians to the experimental or control arm and then stratified by medical specialty. The primary outcome will be fully appropriate prescription of oral ATs ie, that comply with the guidelines in terms of number of drugs, drug class, dosage and duration. To demonstrate a 5% increase in this proportion, we will need to include a minimum of 230 physicians per arm. A logistic mixed model with a clinical vignette-effect and a physician-effect nested in the arm of the study will be used.
ETHICS AND DISSEMINATION


The  Institutional Review Board  of Inserm (IRB00003888) approved our research project (no. 18-492). If the prescription support-tool improves the prescription of oral ATs, we will create an interactive web tool and will assess its impact in terms of clinical outcomes in real-life.
TRIAL REGISTRATION NUMBER


NCT03630874; Pre-results.",2019,They will be randomised to two arms: the experimental arm (access to the prescription support-tool) or the control arm (no prescription support-tool).,"['French general practitioners and cardiologists involved in outpatient settings', 'adults using clinical vignettes']",['prescription support-tool'],['fully appropriate prescription of oral ATs'],"[{'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0175906', 'cui_str': 'Cardiologists'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",,0.134631,They will be randomised to two arms: the experimental arm (access to the prescription support-tool) or the control arm (no prescription support-tool).,"[{'ForeName': 'Lorene', 'Initials': 'L', 'LastName': 'Zerah', 'Affiliation': ""INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université, Paris, France.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Bonnet-Zamponi', 'Affiliation': ""INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université, Paris, France.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Frappé', 'Affiliation': 'IRMG, Institut de recherche en médecine générale, Paris, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'Sorbonne Université, AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière - Charles Foix, Département de cardiologie, Paris, France.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'De Rycke', 'Affiliation': ""INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université, Paris, France.""}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Magnier', 'Affiliation': 'Département de médecine générale, Sorbonne Université, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pautas', 'Affiliation': 'AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière - Charles Foix, Département de gériatrie, Sorbonne Université, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Charles', 'Affiliation': 'Médecine Interne, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': 'Sorbonne Université, AP-HP, Hôpitaux Universitaires Pitié-Salpêtrière - Charles Foix, Département de cardiologie, Paris, France.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Dechartres', 'Affiliation': ""INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université, Paris, France.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Tubach', 'Affiliation': ""INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université, Paris, France.""}]",BMJ open,['10.1136/bmjopen-2018-025544']
3608,31164362,Can goal-setting for patients with multimorbidity improve outcomes in primary care? Cluster randomised feasibility trial.,"INTRODUCTION


Goal-setting is recommended for patients with multimorbidity, but there is little evidence to support its use in general practice.
OBJECTIVE


To assess the feasibility of goal-setting for patients with multimorbidity, before undertaking a definitive trial.
DESIGN AND SETTING


Cluster-randomised controlled feasibility trial of goal-setting compared with control in six general practices.
PARTICIPANTS


Adults with two or more long term health conditions and at risk of unplanned hospital admission.
INTERVENTIONS


General practitioners (GPs) underwent training and patients were asked to consider goals before an initial goal-setting consultation and a follow-up consultation 6 months later. The control group received usual care planning.
OUTCOME MEASURES


Health-related quality of life (EQ-5D-5L), capability (ICEpop CAPability measure for Older people), Patient Assessment of Chronic Illness Care and healthcare use. All consultations were video-recorded or audio-recorded, and focus groups were held with participating GPs and patients.
RESULTS


Fifty-two participants were recruited with a response rate of 12%. Full follow-up data were available for 41. In the goal-setting group, mean age was 80.4 years, 54% were female and the median number of prescribed medications was 13, compared with 77.2 years, 39% female and 11.5 medications in the control group. The mean initial consultation time was 23.0 min in the goal-setting group and 19.2 in the control group. Overall 28% of patient participants had no cognitive impairment. Participants set between one and three goals on a wide range of subjects, such as chronic disease management, walking, maintaining social and leisure interests, and weight management. Patient participants found goal-setting acceptable and would have liked more frequent follow-up. GPs unanimously liked goal-setting and felt it delivered more patient-centred care, and they highlighted the importance of training.
CONCLUSIONS


This goal-setting intervention was feasible to deliver in general practice. A larger, definitive study is needed to test its effectiveness.
TRIAL REGISTRATION NUMBER


ISRCTN13248305; Post-results.",2019,The mean initial consultation time was 23.0 min in the goal-setting group and 19.2 in the control group.,"['Adults with two or more long term health conditions and at risk of unplanned hospital admission', 'six general practices', 'patients with multimorbidity', 'Fifty-two participants were recruited with a response rate of 12', 'patients with multimorbidity, before undertaking a definitive trial', 'mean age was 80.4 years, 54% were female and the median number of prescribed medications was 13, compared with 77.2 years, 39% female and 11.5 medications in the control group', 'Participants set between one and three goals on a wide range of subjects, such as chronic disease management, walking, maintaining social and leisure interests, and weight management']",['usual care planning'],"['cognitive impairment', 'Health-related quality of life (EQ-5D-5L), capability (ICEpop CAPability measure for Older people), Patient Assessment of Chronic Illness Care and healthcare use', 'mean initial consultation time']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0444864', 'cui_str': 'AM 13 (qualifier value)'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",52.0,0.108989,The mean initial consultation time was 23.0 min in the goal-setting group and 19.2 in the control group.,"[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ford', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lenaghan', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Salter', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Shiner', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Allan B', 'Initials': 'AB', 'LastName': 'Clark', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Murdoch', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Patient and public involvement representative, Norwich, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Koopmans', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Lipp', 'Affiliation': 'NHS England Midlands & East (East), Fulbourn, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Moseley', 'Affiliation': 'Patient and public involvement representative, Norwich, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Wade', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Winterburn', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Steel', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}]",BMJ open,['10.1136/bmjopen-2018-025332']
3609,32068667,"A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain.","This clinical trial evaluated the independent and combined effects of a tricyclic antidepressant (desipramine) and cognitive behavioral therapy (CBT) for chronic back pain relative to an active placebo treatment. Participants (n = 142) were patients experiencing daily chronic back pain at an intensity of ≥4/10 who were randomized to a single-center, double-blind, 12-week, 4-arm, parallel groups controlled clinical trial of (1) low concentration desipramine titrated to reach a serum concentration level of 15 to 65 ng/mL; (2) CBT and active placebo medication (benztropine mesylate, 0.125 mg); (3) low concentration desipramine and CBT; and (4) active benztropine placebo medication. Participants completed the Differential Description Scale and Roland Morris Disability Questionnaires before and after treatment as validated measures of outcomes in back pain intensity and disability, respectively. Participants within each condition showed significant reductions from pre-treatment to post-treatment in pain intensity (mean changes ranged from = -2.58 to 3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04 to 4.29, Cohen's d's = 0.54-0.88). However, intent-to-treat analyses at post-treatment showed no significant differences between any condition, with small effect sizes ranging from 0.06 to 0.27. The results from this clinical trial did not support the hypothesis that desipramine, CBT, or their combination would be statistically superior to an active medicine placebo for reducing chronic back pain intensity or disability. Key limitations included recruiting 71% of the planned sample size and use of multiple inclusion/exclusion criteria that may limit generalizability to broader populations of patients with chronic back pain.",2020,"Participants within each condition showed significant reductions from pre to post-treatment in pain intensity (mean changes ranged from = -2.58-3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04-4.29, Cohen's d's = 0.54-0.88).","['patients with chronic back pain', 'low back pain', 'Participants (n=142) were patients experiencing daily chronic back pain at an intensity of ≥4/10 who']","['medicine placebo', 'tricyclic antidepressant (desipramine) and cognitive behavioral therapy (CBT', 'desipramine, CBT', 'placebo', 'CBT and active placebo medication (benzotropine mesylate, 0.125mg); 3) low concentration desipramine and CBT; and 4) active benztropine placebo medication', 'desipramine, cognitive behavioral therapy, and active placebo therapy', 'low concentration desipramine']","['Differential Description Scale and Roland-Morris Disability Questionnaires pre', 'pain intensity', 'pain disability', 'chronic back pain intensity or disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain (finding)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003290', 'cui_str': 'Antidepressant Drugs, Tricyclic'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0011685', 'cui_str': 'Desipramine'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3645051', 'cui_str': 'mesylate'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005098', 'cui_str': 'benzatropine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",142.0,0.562883,"Participants within each condition showed significant reductions from pre to post-treatment in pain intensity (mean changes ranged from = -2.58-3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04-4.29, Cohen's d's = 0.54-0.88).","[{'ForeName': 'Hilary M', 'Initials': 'HM', 'LastName': 'Gould', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Joseph Hampton', 'Initials': 'JH', 'LastName': 'Atkinson', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Chircop-Rollick', 'Affiliation': 'University of California, San Diego, CA, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DʼAndrea', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Garfin', 'Affiliation': 'University of California, San Diego, CA, United States.'}, {'ForeName': 'Shetal M', 'Initials': 'SM', 'LastName': 'Patel', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Funk', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'University of California, San Diego, CA, United States.'}, {'ForeName': 'Donald B', 'Initials': 'DB', 'LastName': 'Penzien', 'Affiliation': 'Wake Forest School of Medicine, Winston Salem, NC, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'University of California, San Diego, CA, United States.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Weickgenanta', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Slater', 'Affiliation': 'HonorHealth Research Institute, Scottsdale, AZ, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rutledge', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}]",Pain,['10.1097/j.pain.0000000000001834']
3610,31796073,NSABP FB-7: a phase II randomized neoadjuvant trial with paclitaxel + trastuzumab and/or neratinib followed by chemotherapy and postoperative trastuzumab in HER2 +  breast cancer.,"PURPOSE


The primary aim of NSABP FB-7 was to determine the pathologic complete response (pCR) rate in locally advanced HER2-positive (HER2 + ) breast cancer patients treated with neoadjuvant trastuzumab or neratinib or the combination and weekly paclitaxel followed by standard doxorubicin plus cyclophosphamide. The secondary aims include biomarker analyses.
EXPERIMENTAL DESIGN


pCR was tested for association with treatment, gene expression, and a single nucleotide polymorphism (SNP) in the Fc fragment of the IgG receptor IIIa-158V/F (FCGR3A). Pre-treatment biopsies and residual tumors were also compared to identify molecular changes.
RESULTS


The numerical pCR rate in the trastuzumab plus neratinib arm (50% [95%CI 34-66%]) was greater than that for single-targeted therapies with trastuzumab (38% [95%CI 24-54]) or neratinib (33% [95%CI 20-50]) in the overall cohort but was not statistically significant. Hormone receptor-negative (HR - ) tumors had a higher pCR rate than HR +  tumors in all three treatment arms, with the highest pCR rate in the combination arm. Diarrhea was the most frequent adverse event and occurred in virtually all patients who received neratinib-based therapy. Grade 3 diarrhea was reported in 31% of patients; there were no grade 4 events. Our 8-gene signature, previously validated for trastuzumab benefit in two different clinical trials in the adjuvant setting, was correlated with pCR across all arms of NSABP FB-7. Specifically, patients predicted to receive no trastuzumab benefit had a significantly lower pCR rate than did patients predicted to receive the most benefit (P = 0.03). FCGR genotyping showed that patients who were homozygous for the Fc low-binding phenylalanine (F) allele for FCGR3A-158V/F were less likely to achieve pCR.
CONCLUSIONS


Combining trastuzumab plus neratinib with paclitaxel increased the absolute pCR rate in the overall cohort and in HR -  patients. The 8-gene signature, which is validated for predicting trastuzumab benefit in the adjuvant setting, was associated with pCR in the neoadjuvant setting, but remains to be validated as a predictive marker in a larger neoadjuvant clinical trial. HR status, and the FCGR3A-158V/F genotype, also warrant further investigation to identify HER2 +  patients who may benefit from additional anti-HER2 therapies beyond trastuzumab. All of these markers will require further validation in the neoadjuvant setting.
TRIALS REGISTRATION


ClinicalTrials.gov, NCT01008150. Retrospectively registered on October 5, 2010.",2019,"Hormone receptor-negative (HR - ) tumors had a higher pCR rate than HR +  tumors in all three treatment arms, with the highest pCR rate in the combination arm.","['locally advanced HER2-positive (HER2 + ) breast cancer patients treated with', 'HER2 +  breast cancer']","['paclitaxel + trastuzumab and/or neratinib followed by chemotherapy and postoperative trastuzumab', 'paclitaxel', 'NSABP FB-7', 'trastuzumab', 'neoadjuvant trastuzumab or neratinib or the combination and weekly paclitaxel followed by standard doxorubicin plus cyclophosphamide']","['Grade 3 diarrhea', 'Diarrhea', 'pCR rate', 'numerical pCR rate', 'absolute pCR rate', 'pathologic complete response (pCR) rate']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C2713008', 'cui_str': 'neratinib'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.0757929,"Hormone receptor-negative (HR - ) tumors had a higher pCR rate than HR +  tumors in all three treatment arms, with the highest pCR rate in the combination arm.","[{'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Jacobs', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA. samuel.jacobs@nsabp.org.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Robidoux', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Jame', 'Initials': 'J', 'LastName': 'Abraham', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Pérez-Garcia', 'Affiliation': 'QuironSalud Group, IOB Institute of Oncology, Madrid, Barcelona, Spain.'}, {'ForeName': 'Nicla', 'Initials': 'N', 'LastName': 'La Verde', 'Affiliation': 'Present address: ASST Fatebenefratelli Sacco - PO Luigi Sacco, Milan, Italy.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Orcutt', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Marina E', 'Initials': 'ME', 'LastName': 'Cazzaniga', 'Affiliation': 'Medica Scientia Innovation Research (MedSIR), Barcelona, Spain.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Piette', 'Affiliation': 'International Drug Development Institute (IDDI), Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Antolín', 'Affiliation': 'Hospital Universitario, Coruña, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Aguirre', 'Affiliation': 'Medica Scientia Innovation Research (MedSIR), Barcelona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': 'QuironSalud Group, IOB Institute of Oncology, Madrid, Barcelona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Llombart-Cussac', 'Affiliation': 'Medica Scientia Innovation Research (MedSIR), Barcelona, Spain.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Di Cosimo', 'Affiliation': 'Medica Scientia Innovation Research (MedSIR), Barcelona, Spain.'}, {'ForeName': 'Rim S', 'Initials': 'RS', 'LastName': 'Kim', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Huichen', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Lipchik', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Lucas', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Srinivasan', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Song', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Gavin', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'April D', 'Initials': 'AD', 'LastName': 'Balousek', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Soonmyung', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Carmen J', 'Initials': 'CJ', 'LastName': 'Allegra', 'Affiliation': 'Department of Medicine, University of Florida Health, Gainsville, FL, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Pogue-Geile', 'Affiliation': 'NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center - Ste 1200, Pittsburgh, PA, 15212, USA.'}]",Breast cancer research : BCR,['10.1186/s13058-019-1196-y']
3611,31116392,The translation of an evidence-based preschool physical activity intervention from in-person to online delivery of professional development to preschool teachers.,"Study of Health and Activity in Preschool Environments (SHAPES) aimed to increase preschoolers' physical activity by engaging preschool teachers in professional development designed to modify instructional practices. SHAPES originated as a randomized controlled trial, tested in 16 preschools and disseminated to 4 control schools, and was shown to be effective in increasing preschool children's physical activity (Phase I, 2008-2012). This article describes the steps taken to translate an evidence-based physical activity intervention, SHAPES, from in-person delivery to online delivery of professional development to preschool teachers. In Phase II (2013-2016), professional development delivery was modified from an in-person to an online program for preschool teachers. Teacher implementation completeness and fidelity were examined in 10 pilot preschools and then replicated in 30 preschools. Large-scale dissemination of SHAPES began in Phase III (2017-2019), reaching 818 teachers from 228 unique centers after 2 years. The final SHAPES program consisted of six online modules, an accompanying guidebook, over 90 activities, self-assessment techniques, a video library, and an electronic community forum. The SHAPES core elements, defined in Phase I, were retained throughout all three phases. The Phase II change to online delivery was characterized by high levels of implementation completeness and fidelity. Results of Phase III statewide dissemination revealed comparable implementation completeness and fidelity. An intervention shown to be effective in a randomized controlled trial can be translated into an online professional development program and disseminated on a large scale in a timely manner.",2019,An intervention shown to be effective in a randomized controlled trial can be translated into an online professional development program and disseminated on a large scale in a timely manner.,"['10 pilot preschools and then replicated in 30 preschools', ""preschool children's physical activity (Phase I, 2008-2012"", 'preschool teachers', '16 preschools and disseminated to 4 control schools']","['preschool physical activity intervention', 'professional development delivery was modified from an in-person to an online program']",['implementation completeness and fidelity'],"[{'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0205221', 'cui_str': 'Disseminated (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439812', 'cui_str': 'Completeness (qualifier value)'}]",,0.0223651,An intervention shown to be effective in a randomized controlled trial can be translated into an online professional development program and disseminated on a large scale in a timely manner.,"[{'ForeName': 'Ruth P', 'Initials': 'RP', 'LastName': 'Saunders', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Public Health Research Center, University of South Carolina, Suite, Columbia, SC, USA.'}, {'ForeName': 'Michaela A', 'Initials': 'MA', 'LastName': 'Schenkelberg', 'Affiliation': 'Department of Health Promotion, University of Nebraska Medical Center, Maurer Center for Public Health, Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Moyer', 'Affiliation': 'Department of Exercise Science, Public Health Research Center, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Howie', 'Affiliation': 'Department of Health, Human Performance, and Recreation, University of Arkansas, Fayetteville, AR, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Brown', 'Affiliation': 'Educational Studies, Wardlaw College, University of South Carolina, Columbia, USA.'}, {'ForeName': 'Russell R', 'Initials': 'RR', 'LastName': 'Pate', 'Affiliation': 'Department of Exercise Science, Public Health Research Center, University of South Carolina, Columbia, SC, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz076']
3612,32145005,Relations between gait characteristics and subjective visual vertical results in young adults.,"OBJECTIVE


Subjective visual vertical (SVV) deviation can indicate impairments of motion perception and spatial orientation in individuals with vestibular disorders. This study investigated the influence of SVV on tandem gait ability by assessing differences between temporal, spatial, and kinematic characteristics in young adults.
METHODS


We recruited sixteen young adults with increased SVV and 17 age-matched control subjects. All subjects recruited for this study were with no history of neurological or musculoskeletal diseases. Knee and hip-joint kinematic data, spatio-temporal parameters, and gait variability were measured during tandem gait.
RESULTS


Stride time variability and stride velocity variability were significantly greater in the experimental group than the control group (p < 0.05). In addition, a significant correlation was observed between stride time variability and SVV results (r = 0.345, p < 0.05). However, hip and knee joint angles were non-significantly different in the experimental and control groups (p > 0.05) and spatio-temporal parameters were similar between the two groups (p > 0.05).
CONCLUSION


Stride time variability and stride velocity variability during tandem gait were significantly different in the experimental and control groups. We presume that increased SVV deviation is related to greater gait variability during tandem gait.",2020,"RESULTS


Stride time variability and stride velocity variability were significantly greater in the experimental group than the control group (p < 0.05).","['young adults', 'All subjects recruited for this study were with no history of neurological or musculoskeletal diseases', 'sixteen young adults with increased SVV and 17 age-matched control subjects', 'individuals with vestibular disorders']","['SVV', 'Subjective visual vertical (SVV) deviation']","['Stride time variability and stride velocity variability', 'Knee and hip-joint kinematic data, spatio-temporal parameters, and gait variability', 'hip and knee joint angles', 'SVV deviation', 'stride time variability and SVV results', 'Stride time variability and stride velocity variability during tandem gait']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0026857', 'cui_str': 'Orthopedic Disorders'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2609434', 'cui_str': 'Vestibular disorders (SMQ)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0019558', 'cui_str': 'Acetabulofemoral Joint'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231779', 'cui_str': 'Heel toe gait (finding)'}]",16.0,0.019152,"RESULTS


Stride time variability and stride velocity variability were significantly greater in the experimental group than the control group (p < 0.05).","[{'ForeName': 'In Hee', 'Initials': 'IH', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Science, Graduate School of Health and Welfare, Dankook University, Republic of Korea.'}, {'ForeName': 'Jung Won', 'Initials': 'JW', 'LastName': 'Kwon', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Dankook University, Republic of Korea.'}, {'ForeName': 'Sang Seok', 'Initials': 'SS', 'LastName': 'Yeo', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Dankook University, Republic of Korea.'}]",Journal of vestibular research : equilibrium & orientation,['10.3233/VES-200694']
3613,31135546,Do Skills Acquired from Training with a Wire Navigation Simulator Transfer to a Mock Operating Room Environment?,"BACKGROUND


Skills training and simulation play an increasingly important role in orthopaedic surgical education. The intent of simulation is to improve performance in the operating room (OR), a trait known as transfer validity. No prior studies have explored how simulator-based wire navigation training can transfer to higher-level tasks. Additionally, there is a lack of knowledge on the format in which wire navigation training should be deployed.
QUESTIONS/PURPOSES


(1) Which training methods (didactic content, deliberate practice, or proficiency-based practice) lead to the greatest improvement in performing a wire navigation task? (2) Does a resident's performance using a wire navigation simulator correlate with his or her performance on a higher-level simulation task in a mock OR involving a C-arm, a radiopaque femur model, and a large soft tissue surrogate surrounding the femur?
METHODS


Fifty-five residents from four different medical centers participated in this study over the course of 2 years. The residents were divided into three groups: traditional training (included first-year residents from the University of Iowa, University of Minnesota, and the Mayo Clinic), deliberate practice (included first-year residents from the University of Nebraska and the University of Minnesota), and proficiency training (included first-year residents from the University of Minnesota and the Mayo Clinic). Residents in each group received a didactic introduction covering the task of placing a wire to treat an intertrochanteric fracture, and this was considered traditional training. Deliberate practice involved training on a radiation-free simulator that provided specific feedback throughout the practice sessions. Proficiency training used the same simulator to train on specific components of wire navigation, like finding the correct starting point, to proficiency before moving to assessment. The wire navigation simulator uses a camera system to track the wire and provide computer-generated fluoroscopy. After training, task performance was assessed in a mock OR. Residents from each group were assessed in the mock OR based on their use of fluoroscopy, total time, and tip-apex distance. Correlation analysis was performed to examine the relationship between resident performance on the simulator and in the mock OR.
RESULTS


Residents in the two simulation-based training groups had a lower tip-apex distance than those in the traditional training group (didactic training tip-apex distance: 24 ± 7 mm, 95% CI, 20-27; deliberate practice tip-apex distance: 16 ± 5 mm, 95% CI, 13-19, p = 0.001; proficiency training tip-apex distance: 15 ± 4 mm, 95% CI, 13-18, p < 0.001). Residents in the proficiency training group used more images than those in the other groups (didactic training: 22 ± 12 images, p = 0.041; deliberate practice: 19 ± 8 images; p = 0.012, proficiency training: 31 ± 14 images). In the two simulation-based training groups, resident performance on the simulator, that is, tip-apex distance, image use, and overall time, was correlated with performance in the mock OR (r-square = 0.15 [p = 0.030], 0.61 [p < 0.001], and 0.43 [p < 0.001], respectively).
CONCLUSIONS


As residency programs are designing their curriculum to train wire navigation skills, emphasis should be placed on providing an environment that allows for deliberate practice with immediate feedback about their performance. Simulators such as the one presented in this study offer a safe environment for residents to learn this key skill.
LEVEL OF EVIDENCE


Level II, therapeutic study.",2019,"RESULTS


Residents in the two simulation-based training groups had a lower tip-apex distance than those in the traditional training group (didactic training tip-apex distance: 24 ± 7 mm, 95% CI, 20-27; deliberate practice tip-apex distance: 16 ± 5 mm, 95% CI, 13-19, p = 0.001; proficiency training tip-apex distance: 15 ± 4 mm, 95% CI, 13-18, p < 0.001).","['Fifty-five residents from four different medical centers participated in this study over the course of 2 years', 'included first-year residents from the University of Iowa, University of Minnesota, and the Mayo Clinic), deliberate practice (included first-year residents from the University of Nebraska and the University of Minnesota), and proficiency training (included first-year residents from the University of Minnesota and the Mayo Clinic', '1']","['traditional training', 'wire navigation simulator', 'didactic introduction covering the task of placing a wire to treat an intertrochanteric fracture, and this was considered traditional training', 'simulator-based wire navigation training']",['lower tip-apex distance'],"[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0027523', 'cui_str': 'Nebraska'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005978', 'cui_str': 'Bone Wires'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0162385', 'cui_str': 'Intertrochanteric Fractures'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",,0.0236574,"RESULTS


Residents in the two simulation-based training groups had a lower tip-apex distance than those in the traditional training group (didactic training tip-apex distance: 24 ± 7 mm, 95% CI, 20-27; deliberate practice tip-apex distance: 16 ± 5 mm, 95% CI, 13-19, p = 0.001; proficiency training tip-apex distance: 15 ± 4 mm, 95% CI, 13-18, p < 0.001).","[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Long', 'Affiliation': 'S. A. Long, G. Thomas, M. D. Karam, D. D. Anderson, Department of Orthopedics and Rehabilitation, The University of Iowa, Iowa City, IA, USA S. A. Long, D. D. Anderson, Department of Biomedical Engineering, University of Iowa, Iowa City, IA, USA G. Thomas, D. D. Anderson, Department of Industrial and Systems Engineering, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Geb', 'Initials': 'G', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Karam', 'Affiliation': ''}, {'ForeName': 'Donald D', 'Initials': 'DD', 'LastName': 'Anderson', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000799']
3614,30246923,Feasibility and acceptability of a motivational interviewing breastfeeding peer support intervention.,"An uncontrolled study with process evaluation was conducted in three U.K. community maternity sites to establish the feasibility and acceptability of delivering a novel breastfeeding peer-support intervention informed by motivational interviewing (MI; Mam-Kind). Peer-supporters were trained to deliver the Mam-Kind intervention that provided intensive one-to-one peer-support, including (a) antenatal contact, (b) face-to-face contact within 48 hr of birth, (c) proactive (peer-supporter led) alternate day contact for 2 weeks after birth, and (d) mother-led contact for a further 6 weeks. Peer-supporters completed structured diaries and audio-recorded face-to-face sessions with mothers. Semistructured interviews were conducted with a purposive sample of mothers, health professionals, and all peer-supporters. Interview data were analysed thematically to assess intervention acceptability. Audio-recorded peer-support sessions were assessed for intervention fidelity and the use of MI techniques, using the MITI 4.2 tool. Eight peer-supporters delivered the Mam-Kind intervention to 70 mothers in three National Health Service maternity services. Qualitative interviews with mothers (n = 28), peer-supporters (n = 8), and health professionals (n = 12) indicated that the intervention was acceptable, and health professionals felt it could be integrated with existing services. There was high fidelity to intervention content; 93% of intervention objectives were met during sessions. However, peer-supporters reported difficulties in adapting from an expert-by-experience role to a collaborative role. We have established the feasibility and acceptability of providing breastfeeding peer-support using a MI-informed approach. Refinement of the intervention is needed to further develop peer-supporters' skills in providing mother-centred support. The refined intervention should be tested for effectiveness in a randomised controlled trial.",2019,"Audio-recorded peer-support sessions were assessed for intervention fidelity and the use of MI techniques, using the MITI 4.2 tool.","['70 mothers in three National Health Service maternity services', 'Qualitative interviews with mothers (n\xa0=\xa028), peer-supporters (n\xa0=\xa08), and health professionals (n\xa0=\xa012']","['Eight peer-supporters delivered the Mam-Kind intervention', 'Peer-supporters completed structured diaries and audio-recorded face-to-face sessions with mothers', 'novel breastfeeding peer-support intervention informed by motivational interviewing (MI; Mam-Kind', 'Mam-Kind intervention that provided intensive one-to-one peer-support, including (a) antenatal contact, (b) face-to-face contact within 48\xa0hr of birth, (c) proactive (peer-supporter led) alternate day contact', 'motivational interviewing breastfeeding peer support intervention']",['Feasibility and acceptability'],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0558287', 'cui_str': 'Alternate days (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0335016,"Audio-recorded peer-support sessions were assessed for intervention fidelity and the use of MI techniques, using the MITI 4.2 tool.","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Copeland', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Merrett', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'McQuire', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Grant', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gobat', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Tedstone', 'Affiliation': 'Royal United Hospitals Bath, NHS Foundation Trust, Bath, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Playle', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Hunter', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Department of Public Health, Policy and Social Sciences, Swansea University, Swansea, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Fitzsimmons', 'Affiliation': 'Department of Public Health, Policy and Social Sciences, Swansea University, Swansea, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Shantini', 'Initials': 'S', 'LastName': 'Paranjothy', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}]",Maternal & child nutrition,['10.1111/mcn.12703']
3615,31176205,Postoperative adjuvant IMRT for patients with HCC and portal vein tumor thrombus: An open-label randomized controlled trial.,"AIMS


To investigate the impact of postoperative intensity modulated radiation therapy (IMRT) in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT) after partial hepatectomy +/- thrombectomy.
METHODS


From July 2013 to June 2016, consecutive patients with HCC and PVTT who underwent partial hepatectomy were randomly assigned to 2 groups: a control group and an adjuvant IMRT group. Survival outcomes in the 2 groups were studied.
RESULTS


The 52 patients in this study were equally randomized into 2 groups with comparable clinicopathological data. The median disease-free survival (DFS) and overall survival (OS) were 9.1 ± 1.6 months, 18.9 ± 1.8 months for the adjuvant RT group and 4.1 ± 0.5 months, 10.8 ± 1.3 months for the control group, respectively. The 1-, 2- and 3-years overall survival rates were significantly better in the adjuvant IMRT group (76.9%, 19.2%, and 11.5%; respectively) than the control group (26.9%, 11.5% and 0%, respectively; p = 0.005).
CONCLUSIONS


Postoperative IMRT significantly improved the overall survival outcomes in patients with HCC and PVTT after partial hepatectomy +/- thrombectomy.",2019,"The 1-, 2- and 3-years overall survival rates were significantly better in the adjuvant IMRT group (76.9%, 19.2%, and 11.5%; respectively) than the control group (26.9%, 11.5% and 0%, respectively; p = 0.005).
","['52 patients', 'From July 2013 to June 2016, consecutive patients with HCC and PVTT who underwent partial hepatectomy', 'patients with HCC and PVTT after partial hepatectomy ', 'patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT) after partial hepatectomy ', 'patients with HCC and portal vein tumor thrombus']","['control group and an adjuvant IMRT', 'Postoperative adjuvant IMRT', 'adjuvant IMRT', 'postoperative intensity modulated radiation therapy (IMRT']","['overall survival outcomes', 'Survival outcomes', 'median disease-free survival (DFS) and overall survival (OS', 'overall survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0193398', 'cui_str': 'Partial hepatectomy (procedure)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C3163918', 'cui_str': 'Tumor thrombus'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0738758,"The 1-, 2- and 3-years overall survival rates were significantly better in the adjuvant IMRT group (76.9%, 19.2%, and 11.5%; respectively) than the control group (26.9%, 11.5% and 0%, respectively; p = 0.005).
","[{'ForeName': 'Juxian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Radiotherapy, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xiuping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zongtao', 'Initials': 'Z', 'LastName': 'Chai', 'Affiliation': 'Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Wan Yee', 'Initials': 'WY', 'LastName': 'Lau', 'Affiliation': 'Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China; Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'Department of Radiotherapy, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China. Electronic address: yanmeng_ehbh@163.com.'}, {'ForeName': 'Shu-Qun', 'Initials': 'SQ', 'LastName': 'Cheng', 'Affiliation': 'Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China. Electronic address: chengshuqun@aliyun.com.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2019.05.006']
3616,31864519,Adding Chiropractic Treatment to Individual Rehabilitation for Persistent Pelvic Girdle Pain 3 to 6 Months After Delivery: A Pilot Randomized Trial.,"OBJECTIVE


The purpose of this study was to investigate the feasibility of conducting a study examining the influence of individualized rehabilitation and chiropractic treatment, compared with individualized rehabilitation alone, in women with persistent dominating 1-sided pelvic girdle pain (PGP) 3 to 6 months after delivery.
METHODS


Women were recruited from an outpatient clinic at Stavanger University Hospital, Norway and in a private chiropractic clinic in Stavanger. Those with persistent, dominating 1-sided PGP were included in this pilot study. Those who met inclusion criteria were randomized into 2 groups, one group received individualized rehabilitation and chiropractic treatment and the other group women received individualized rehabilitation alone. Treatment was measured for 20 weeks.
RESULTS


Of 330 consenting women who were recruited who reported pelvic pain during pregnancy, 68 reported PGP or low back pain, and 63 consented to fill in a questionnaire. Forty-seven women underwent a clinical examination 3 to 6 months after delivery. During the examination, the women were diagnosed into subgroups for PGP. After exclusion of the women with low back pain only, a total of 13 women were diagnosed with dominating 1-sided PGP and thus included in this study. Six were randomized to the individualized rehabilitation and chiropractic treatment group and 5 to the individualized rehabilitation alone group. After 20 weeks of intervention, both groups reported improvement in disability and pain, but not in general health status. No serious or long-lasting adverse events were registered after treatment or training.
CONCLUSION


We found that a study of this nature is feasible. However, the conditions of patient recruitment need to be considered carefully. We learned that a trial to investigate the effect of chiropractic treatment for PGP pain should include all subgroups of PGP to reach an acceptable sample size.",2019,"No serious or long-lasting adverse events were registered after treatment or training.
","['330 consenting women who were recruited who reported pelvic pain during pregnancy, 68 reported PGP or low back pain, and 63 consented to fill in a questionnaire', 'Women were recruited from an outpatient clinic at Stavanger University Hospital, Norway and in a private chiropractic clinic in Stavanger', 'Forty-seven women underwent a clinical examination 3 to 6 months after delivery', 'women with persistent dominating 1-sided pelvic girdle pain (PGP) 3 to 6 months after delivery']","['individualized rehabilitation alone', 'individualized rehabilitation and chiropractic treatment and the other group women received individualized rehabilitation alone', 'individualized rehabilitation and chiropractic treatment group and 5 to the individualized rehabilitation alone group', 'individualized rehabilitation and chiropractic treatment']","['disability and pain', 'No serious or long-lasting adverse events', 'general health status']","[{'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0240682', 'cui_str': 'Pelvic Girdle Pain'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",47.0,0.0633577,"No serious or long-lasting adverse events were registered after treatment or training.
","[{'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Gausel', 'Affiliation': 'Department of Obstetrics and Gynecology, Stavanger University Hospital, Stavanger, Norway. Electronic address: amgausel@hotmail.com.'}, {'ForeName': 'Ingvild', 'Initials': 'I', 'LastName': 'Dalen', 'Affiliation': 'Department of Research, Section of Biostatistics, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Kjærmann', 'Affiliation': 'Department of Research, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Malmqvist', 'Affiliation': 'The Norwegian Centre for Movement Disorders, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Andersen', 'Affiliation': 'Department of Research, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Jan Petter', 'Initials': 'JP', 'LastName': 'Larsen', 'Affiliation': 'Network for Medical Sciences, University of Stavanger, Stavanger, Norway.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Økland', 'Affiliation': 'Department of Obstetrics and Gynecology, Stavanger University Hospital, Stavanger, Norway.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2018.12.006']
3617,31347444,Debiasing Training Improves Decision Making in the Field.,"The primary objection to debiasing-training interventions is a lack of evidence that they improve decision making in field settings, where reminders of bias are absent. We gave graduate students in three professional programs ( N  = 290) a one-shot training intervention that reduces confirmation bias in laboratory experiments. Natural variance in the training schedule assigned participants to receive training before or after solving an unannounced business case modeled on the decision to launch the Space Shuttle Challenger. We used case solutions to surreptitiously measure participants' susceptibility to confirmation bias. Trained participants were 29% less likely to choose the inferior hypothesis-confirming solution than untrained participants. Analysis of case write-ups suggests that a reduction in confirmatory hypothesis testing accounts for their improved decision making in the case. The results provide promising evidence that debiasing-training effects transfer to field settings and can improve decision making in professional and private life.",2019,Analysis of case write-ups suggests that a reduction in confirmatory hypothesis testing accounts for their improved decision making in the case.,['graduate students in three professional programs ( N  = 290) a'],"['Debiasing Training', 'one-shot training intervention']",[],"[{'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],,0.0553888,Analysis of case write-ups suggests that a reduction in confirmatory hypothesis testing accounts for their improved decision making in the case.,"[{'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Sellier', 'Affiliation': 'Marketing Department, HEC Paris.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Scopelliti', 'Affiliation': 'Faculty of Management, Cass Business School, City, University of London.'}, {'ForeName': 'Carey K', 'Initials': 'CK', 'LastName': 'Morewedge', 'Affiliation': 'Department of Marketing, Questrom School of Business, Boston University.'}]",Psychological science,['10.1177/0956797619861429']
3618,30952500,"Kinetics of maternally-derived serogroup A, C, Y and W-specific meningococcal immunoglobulin G in Malian women and infants.","A prospective, randomised, controlled observer-blind trial measuring the efficacy and immunogenicity of trivalent influenza vaccine (TIV) and the immunogenicity of quadrivalent meningococcal conjugate vaccine (MCV) in pregnant women and their infants up to 6 months of age was conducted in Mali. Here we reported the immunogenicity of MCV, which was used as a comparator vaccine to TIV, in this population. Third-trimester pregnant Malian women were randomized to receive TIV or MCV. Blood samples were collected from women prior to vaccination, 28 days post-vaccination, at delivery and 3 and 6 months post-delivery and from infants at birth and 3 and 6 months of age. Meningococcal-specific serogroup (Men) A, C, Y and W-specific antibodies were measured by enzyme linked immunosorbent assay in a randomly selected subset of 50 mother-infant pairs where the mother had received MCV. At birth, 94.0% (47/50) of infants had MenA specific IgG levels ≥ 2 µg/mL decreasing to 72.9% and 30.4% at 3 and 6 months of age. For MenC, 81.3% (39/48) of infants had MenC specific IgG levels ≥ 2 µg/mL at birth decreasing to 29.4% and 17.8% at 3 and 6 months of age. For MenY, 89.6% (43/48) of infants had MenY specific IgG levels ≥ 2 µg/mL at birth decreasing to 64.6% and 62.5% at 3 and 6 months of age. For MenW, 89.6% (43/48) of infants had MenW specific IgG levels ≥ 2 μg/ml at birth decreasing to 62.5% and 41.7% at 3 and 6 months of age. Maternal immunization with MCV conveyed protective levels of IgG at birth through to 3 months of age in the majority of infants.",2019,"For MenY, 89.6% (43/48) of infants had MenY specific IgG levels ≥ ","['pregnant women and their infants up to 6\u202fmonths of age was conducted in Mali', 'Third-trimester pregnant Malian women', 'Malian women and infants']","['TIV or MCV', 'trivalent influenza vaccine (TIV', 'MCV', 'quadrivalent meningococcal conjugate vaccine (MCV']",['MenC specific IgG levels\u202f≥'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C1961129', 'cui_str': 'Microvolt'}, {'cui': 'C0770694'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.121359,"For MenY, 89.6% (43/48) of infants had MenY specific IgG levels ≥ ","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Findlow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK. Electronic address: helenfindlow@hotmail.com.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Tapia', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'S O', 'Initials': 'SO', 'LastName': 'Sow', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Haidara', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Coulibaly', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Keita', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Diallo', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Doumbia', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Traore', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Schluterman', 'Affiliation': 'Department of Epidemiology, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Clark', 'Affiliation': 'Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borrow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Levine', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.03.045']
3619,32065415,"Ascending-Dose Study of Controlled-Release Ketamine Tablets in Healthy Volunteers: Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability.","Parenteral ketamine has fast-onset antidepressant and antianxiety effects; however, it causes dissociation, hypertension, and tachycardia shortly after dosing. Ketamine's antidepressant effects may be due to active metabolites rather than to ketamine itself. We hypothesized that oral controlled-release ketamine tablets would improve safety and tolerability compared with injected ketamine by reducing peak ketamine exposures compared with dosing by injection. In this randomized, placebo-controlled ascending-dose study, ketamine doses of 60, 120, or 240 mg or matching placebo (single dose followed by every-12-hours dosing for 5 doses) were given to 24 healthy volunteers. Pharmacokinetics, pharmacodynamics (brain-derived neurotropic factor), adverse events, and vital signs were assessed up to 72 hours. Drug release occurred over ∼10 hours, with most drug substance present as norketamine (∼90%). Area under the concentration-time curve and peak concentration were dose proportional. Elimination half-life was prolonged (7-9 hours) compared with published data from immediate-release oral formulations. There were no changes in blood pressure or heart rate after any dose. Mild dissociation was reported after 240 mg but not lower doses; mean dissociation ratings in this group were minimal (1-2/76). There were no clinically significant changes in ECGs or safety laboratory tests at any time. Compared with injected ketamine, oral controlled-release ketamine tablets did not increase blood pressure or heart rate, and only at doses of 240 mg was dissociation of mild intensity reported. Reducing and delaying ketamine peak concentration by oral dosing with controlled-release ketamine tablets improve this drug's tolerability for patients with depression/anxiety.",2020,"Compared with injected ketamine, oral controlled-release ketamine tablets did not increase blood pressure or heart rate, and only at doses of 240 mg was dissociation of mild intensity reported.","['24 healthy volunteers', 'Healthy Volunteers', 'patients with depression/anxiety']","['Ketamine', 'matching placebo', 'placebo', 'ketamine', 'Parenteral ketamine', 'ketamine, oral controlled-release ketamine tablets', 'Controlled-Release Ketamine Tablets']","['mean dissociation ratings', 'Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability', 'concentration-time curve and peak concentration', 'Pharmacokinetics, pharmacodynamics (brain-derived neurotropic factor), adverse events, and vital signs', 'blood pressure or heart rate', 'Drug release', 'ECGs or safety laboratory tests', 'Mild dissociation', 'safety and tolerability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086168', 'cui_str': 'Dissociation'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3850077', 'cui_str': 'Drug Dissolution'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}]",24.0,0.0592331,"Compared with injected ketamine, oral controlled-release ketamine tablets did not increase blood pressure or heart rate, and only at doses of 240 mg was dissociation of mild intensity reported.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Glue', 'Affiliation': 'Psychological Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Medlicott', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Surman', 'Affiliation': 'Douglas Pharmaceuticals, Auckland, New Zealand.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Lam', 'Affiliation': 'Zenith Technology Ltd, Dunedin, New Zealand.'}, {'ForeName': 'Noelyn', 'Initials': 'N', 'LastName': 'Hung', 'Affiliation': 'Zenith Technology Ltd, Dunedin, New Zealand.'}, {'ForeName': 'C Tak', 'Initials': 'CT', 'LastName': 'Hung', 'Affiliation': 'Zenith Technology Ltd, Dunedin, New Zealand.'}]",Journal of clinical pharmacology,['10.1002/jcph.1573']
3620,31821109,NSABP B-47/NRG Oncology Phase III Randomized Trial Comparing Adjuvant Chemotherapy With or Without Trastuzumab in High-Risk Invasive Breast Cancer Negative for HER2 by FISH and With IHC 1+ or 2.,"PURPOSE


Adjuvant trastuzumab reduces invasive breast cancer (IBC) recurrence and risk for death in patients with HER2-amplified or overexpressing IBC. A subset of patients in the landmark trastuzumab adjuvant trials who originally tested HER2-positive but were HER2-negative by central HER2 testing appeared to possibly benefit from trastuzumab. The objective for the NSABP B-47 trial was to determine whether the addition of trastuzumab to adjuvant chemotherapy (CRx) would improve invasive disease-free survival (IDFS) in patients with HER2-negative breast cancer.
PATIENTS AND METHODS


A total of 3,270 women with high-risk primary IBC were randomly assigned to CRx with or without 1 year of trastuzumab. Eligibility criteria included immunohistochemistry (IHC) score 1+ or 2+ with fluorescence in situ hybridization ratio (FISH) < 2.0 or, if ratio was not performed, HER2 gene copy number < 4.0. CRx was either docetaxel plus cyclophosphamide or doxorubicin and cyclophosphamide followed by weekly paclitaxel for 12 weeks.
RESULTS


At a median follow-up of 46 months, the addition of trastuzumab to CRx did not improve IDFS (5-year IDFS: 89.8% with CRx plus trastuzumab [CRxT]  v  89.2% with CRx alone; hazard ratio [HR], 0.98; 95% CI, 0.76 to 1.25;  P  = .85). These findings did not differ by level of HER2 IHC expression, lymph node involvement, or hormone-receptor status. For distant recurrence-free interval, 5-year estimates were 92.7% with CRxT compared with 93.6% for CRx alone (HR, 1.10; 95% CI, 0.81 to 1.50;  P  = .55) and for overall survival (OS) were 94.8% with CRxT and 96.3% in CRx alone (HR, 1.33; 95% CI, 0.90 to 1.95;  P  = .15). There were no unexpected toxicities from the addition of trastuzumab to CRx.
CONCLUSION


The addition of trastuzumab to CRx did not improve IDFS, distant recurrence-free interval, or OS in women with non-HER2-overexpressing IBC. Trastuzumab does not benefit women without IHC 3+ or FISH ratio-amplified breast cancer.",2020,"The addition of trastuzumab to CRx did not improve IDFS, distant recurrence-free interval, or OS in women with non-HER2-overexpressing IBC.","['3,270 women with high-risk primary IBC', 'patients with HER2-negative breast cancer', 'patients with HER2-amplified or overexpressing IBC']","['trastuzumab to adjuvant chemotherapy (CRx', 'Adjuvant Chemotherapy', 'CRx with or without 1 year of trastuzumab', 'CRx plus trastuzumab [CRxT', 'Trastuzumab', 'docetaxel plus cyclophosphamide or doxorubicin and cyclophosphamide', 'trastuzumab']","['IDFS, distant recurrence-free interval, or OS', 'invasive disease-free survival (IDFS', 'level of HER2 IHC expression, lymph node involvement, or hormone-receptor status', 'toxicities', 'IDFS ', 'distant recurrence-free interval, 5-year estimates', '5-year IDFS', 'overall survival (OS', 'invasive breast cancer (IBC) recurrence and risk for death']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0449443', 'cui_str': 'Receptor status (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",3270.0,0.231243,"The addition of trastuzumab to CRx did not improve IDFS, distant recurrence-free interval, or OS in women with non-HER2-overexpressing IBC.","[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fehrenbacher', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Reena S', 'Initials': 'RS', 'LastName': 'Cecchini', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Costantino', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Atkins', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Crown', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Polikoff', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Boileau', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Provencher', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Stokoe', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Moore', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Robidoux', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Flynn', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Virginia F', 'Initials': 'VF', 'LastName': 'Borges', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Swain', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Soonmyung', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Eleftherios P', 'Initials': 'EP', 'LastName': 'Mamounas', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01455']
3621,32073676,"Beta-blockers withdrawal in patients with heart failure with preserved ejection fraction and chronotropic incompetence: Effect on functional capacity rationale and study design of a prospective, randomized, controlled trial (The Preserve-HR trial).","BACKGROUND


The pathophysiology of heart failure with preserved ejection fraction (HFpEF) is complex and multifactorial. Chronotropic incompetence (ChI) has emerged as a crucial pathophysiological mechanism. Beta-blockers, drugs with negative chronotropic effects, are commonly used in HFpEF, although current evidence does not support its routine use in these patients.
HYPOTHESIS


We postulate beta-blockers may have deleterious effects in HFpEF and ChI. This work aims to evaluate the short-term effect of beta-blockers withdrawal on functional capacity assessed by the maximal oxygen uptake (peakVO2) in patients with HFpEF and ChI.
METHODS


This is a prospective, crossover, randomized (1:1) and multicenter study. After randomization, the clinical and cardiac rhythm will be continuously registered for 30 days. PeakVO2 is assessed by cardiopulmonary exercise testing (CPET) at 15 and 30 days in both groups. Secondary endpoints include quality of life, cognitive, and safety assessment. Patients with stable HFpEF, functional class New York Heart Association (NYHA) II-III, chronic treatment with beta-blockers, and ChI will be enrolled. A sample size estimation [alfa: 0.05, power: 90%, a 20% loss rate, and delta change of mean peakVO2: +1.2 mL/kg/min (SD ± 2.0)] of 52 patients is necessary to test our hypothesis.
RESULTS


Patients started enrolling in October 2018. As January 14th, 2020, 28 patients have been enrolled. It is projected to enroll the last patient at the end of July 2020.
CONCLUSIONS


Optimizing therapy that improves functional capacity remains an unmeet priority in HFpEF. Deprescribing beta-blockers in patients with HFpEF and ChI seems a plausible intervention to improve functional capacity. This trial is an attempt towards precision medicine in this complex syndrome.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03871803.",2020,Deprescribing beta-blockers in patients with HFpEF and ChI seems a plausible intervention to improve functional capacity.,"['Patients started enrolling in October 2018', 'patients with heart failure with preserved ejection fraction and chronotropic incompetence', '28 patients have been enrolled', 'Patients with stable HFpEF, functional class New York Heart Association (NYHA) II-III, chronic treatment with beta-blockers, and ChI will be enrolled', 'patients with HFpEF and ChI', 'patients with HFpEF and ChI.\nMETHODS']",[],"['loss rate, and delta change of mean peakVO2', 'quality of life, cognitive, and safety assessment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1997984', 'cui_str': 'Chronotropic incompetence (finding)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C1720589', 'cui_str': 'Greek letter chi'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",[],"[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.124945,Deprescribing beta-blockers in patients with HFpEF and ChI seems a plausible intervention to improve functional capacity.,"[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Palau', 'Affiliation': 'FISABIO. Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Seller', 'Affiliation': 'Cardiology Department, Hospital de Denia, Alicante, Spain.'}, {'ForeName': 'Eloy', 'Initials': 'E', 'LastName': 'Domínguez', 'Affiliation': 'FISABIO. Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Gómez', 'Affiliation': 'Cardiology Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Ramón', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Sastre', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de la Espriella', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Santas', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Miñana', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Chorro', 'Affiliation': 'CIBERCV, Madrid, Spain.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'González-Juanatey', 'Affiliation': 'Cardiology Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Núñez', 'Affiliation': 'CIBERCV, Madrid, Spain.'}]",Clinical cardiology,['10.1002/clc.23345']
3622,32115311,Aggression Prevention Training for Individuals With Dementia and Their Caregivers: A Randomized Controlled Trial.,"OBJECTIVE


International appeals call for interventions to prevent aggression and other behavioral problems in individuals with dementia (IWD). Aggression Prevention Training (APT), based on intervening in three contributors to development of aggression (IWD pain, IWD depression, and caregiver-IWD relationship problems) aims to reduce incidence of aggression in IWD over 1 year.
DESIGN


Randomized, controlled trial.
SETTING


Three clinics that assess, diagnose, and treat dementia.
PARTICIPANTS


Two hundred twenty-eight caregiver-IWD dyads who screened positive for IWD pain, IWD depression, or caregiver-IWD relationship problems randomized to APT or Enhanced Usual Primary Care (EU-PC).
INTERVENTION


APT, a skills-based intervention delivered over 3 months to address pain/depression/caregiver-IWD relationship issues. EU-PC included printed material on dementia and community resources; and eight brief, weekly support calls.
MEASUREMENTS


The primary outcome was incidence of aggression over 1 year, determined by the Cohen Mansfield Agitation Inventory-Aggression Subscale. Secondary outcomes included pain, depression, caregiver-IWD relationship, caregiver burden, positive caregiving, behavior problems, and anxiety.
RESULTS


Aggression incidence and secondary outcomes did not differ between groups. However, in those screening positive for IWD depression or caregiver-IWD relationship problems, those receiving EU-PC had significant increases in depression and significant decreases in quality of the caregiver-IWD relationship, whereas those receiving APT showed no changes in these outcomes over time.
CONCLUSION


The cost to patients, family, and society of behavioral problems in IWD, along with modest efficacy of most pharmacologic and nonpharmacologic interventions, calls for more study of novel preventive approaches.",2020,"RESULTS


Aggression incidence and secondary outcomes did not differ between groups.","['Two hundred twenty-eight caregiver-IWD dyads who screened positive for IWD pain, IWD depression, or caregiver-IWD relationship problems randomized to APT or Enhanced Usual Primary Care (EU-PC', 'Three clinics that assess, diagnose, and treat dementia', 'individuals with dementia (IWD', 'Individuals With Dementia and Their Caregivers']","['Aggression Prevention Training', 'Aggression Prevention Training (APT']","['incidence of aggression over 1 year, determined by the Cohen Mansfield Agitation Inventory-Aggression Subscale', 'IWD pain, IWD depression, and caregiver-IWD relationship problems', 'depression', 'quality of the caregiver-IWD relationship', 'pain, depression, caregiver-IWD relationship, caregiver burden, positive caregiving, behavior problems, and anxiety']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0425168', 'cui_str': 'Relationship problems (finding)'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0003645', 'cui_str': 'APT'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0425168', 'cui_str': 'Relationship problems (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",228.0,0.24421,"RESULTS


Aggression incidence and secondary outcomes did not differ between groups.","[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Kunik', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (MEK, DR, TE, ABA), Houston, TX; VA South Central Mental Illness Research, Education and Clinical Center (a virtual center) (MEK, DR, TE, ABA); Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX; Michael E. DeBakey VA Medical Center (MEK, SR, JF), Houston, TX. Electronic address: mkunik@bcm.edu.'}, {'ForeName': 'Melinda A', 'Initials': 'MA', 'LastName': 'Stanley', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Srijana', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX; Wheaton College (SS), Norton, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ramsey', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (MEK, DR, TE, ABA), Houston, TX; VA South Central Mental Illness Research, Education and Clinical Center (a virtual center) (MEK, DR, TE, ABA); Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Richey', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX; Michael E. DeBakey VA Medical Center (MEK, SR, JF), Houston, TX.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Snow', 'Affiliation': 'Tuscaloosa VA Medical Center (LS), Tuscaloosa, AL; The University of Alabama Center for Mental Health and Aging (LS), Tuscaloosa, AL.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Freshour', 'Affiliation': 'Michael E. DeBakey VA Medical Center (MEK, SR, JF), Houston, TX.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Evans', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (MEK, DR, TE, ABA), Houston, TX; VA South Central Mental Illness Research, Education and Clinical Center (a virtual center) (MEK, DR, TE, ABA); Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Newmark', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX; Kelsey Seybold Research Foundation (MN), West University Place, TX.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}, {'ForeName': 'Amber B', 'Initials': 'AB', 'LastName': 'Amspoker', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (MEK, DR, TE, ABA), Houston, TX; VA South Central Mental Illness Research, Education and Clinical Center (a virtual center) (MEK, DR, TE, ABA); Baylor College of Medicine (MEK, MAS, SS, DR, SR, TE, MN, SW, NW, ABA), Houston, TX.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.01.190']
3623,32098716,Masked comparison of two silicone hydrogel bandage contact lenses after photorefractive keratectomy.,"PURPOSE


To compare the efficiency and safety of two bandage contact lenses after photorefractive keratectomy (PRK).
METHODS


In this double-blind study, 45 patients (90 eyes) received PRK in both eyes and wore bandage contact lenses (BCLs), PureVision (Bausch & Lomb, Rochester, NY, USA) in one eye and PureVision2 (Bausch & Lomb, Rochester, NY, USA) in the other eye, randomly assigned. The medication regimen after surgery was the same for both eyes. The epithelial defect's size, conjunctival hyperemia and lens centration were graded objectively using slit-lamp biomicroscopy on days 1, 3 and 5 after surgery. Also ocular symptoms of discomfort including tearing, photophobia, foreign body sensation and visual fluctuations were assessed subjectively at each visit.
RESULTS


The mean epithelial defect size on the first day after operation was similar in eyes fitted with PureVision (30.08 ± 5.30 mm²) and PureVision2 (30.25 ± 5.72 mm 2 ) lenses. (p = 0.79) Contact lens deposits and bulbar hyperaemia on days 1 and 3 after PRK were similar between the two eyes, but were significantly greater on day 5 for PureVision2 lenses. (p = 0.02; p = 0.04 respectively) There was no difference in contact lens decentration, and discomfort symptoms including pain, tearing, foreign body sensation, photophobia and visual fluctuations between the eyes fitted with PureVision and PureVision2. (p > 0.05) CONCLUSIONS: PureVision and PureVision2 contact lenses are equivalent as bandage lenses in important aspects such as corneal re-epithelialization and subjective comfort., although PureVision2 led to a higher incidence of contact lens deposits and conjunctival hyperemia early post-PRK.",2020,"There was no difference in contact lens decentration, and discomfort symptoms including pain, tearing, foreign body sensation, photophobia and visual fluctuations between the eyes fitted with PureVision and PureVision2.",['45 patients (90 eyes) received'],"['PureVision and PureVision2 contact lenses', 'PRK in both eyes and wore bandage contact lenses (BCLs), PureVision (Bausch & Lomb, Rochester, NY, USA', 'bandage contact lenses after photorefractive keratectomy (PRK', 'silicone hydrogel bandage contact lenses']","[""epithelial defect's size, conjunctival hyperemia and lens centration"", 'ocular symptoms of discomfort including tearing, photophobia, foreign body sensation and visual fluctuations', 'efficiency and safety', 'mean epithelial defect size', 'contact lens decentration, and discomfort symptoms including pain, tearing, foreign body sensation, photophobia and visual fluctuations', 'Contact lens deposits and bulbar hyperaemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0395416', 'cui_str': 'Photorefractive Keratectomy'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage (procedure)'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C1449669', 'cui_str': 'Bandages, Hydrogel'}]","[{'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia (finding)'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation (finding)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}]",45.0,0.067977,"There was no difference in contact lens decentration, and discomfort symptoms including pain, tearing, foreign body sensation, photophobia and visual fluctuations between the eyes fitted with PureVision and PureVision2.","[{'ForeName': 'Homa', 'Initials': 'H', 'LastName': 'Bagherian', 'Affiliation': 'Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Zarei-Ghanavati', 'Affiliation': 'Health Promotion Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Momeni-Moghaddam', 'Affiliation': 'Health Promotion Research Center, Zahedan University of Medical Sciences, Zahedan, Iran; Department of Optometry, School of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: hmomeni_opt@zaums.ac.ir.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Wolffsohn', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Sedaghat', 'Affiliation': 'Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shehzad A', 'Initials': 'SA', 'LastName': 'Naroo', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Naeemeh', 'Initials': 'N', 'LastName': 'Monfared', 'Affiliation': 'Department of Optometry, School of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.02.005']
3624,31394276,Recombinant Zoster Vaccine Significantly Reduces the Impact on Quality of Life Caused by Herpes Zoster in Adult Autologous Hematopoietic Stem Cell Transplant Recipients: A Randomized Placebo-Controlled Trial (ZOE-HSCT).,"Herpes zoster (HZ) can have a substantial impact on quality of life (QoL). The vaccine efficacy (VE) of a recombinant zoster vaccine (RZV) was 68.2% (95% confidence interval [CI], 55.6% to 77.5%) in a phase 3 study in adult autologous hematopoietic stem cell transplant (HSCT) recipients (NCT01610414). Herein, we report the impact of RZV on patients' QoL. Autologous HSCT recipients were randomized 1:1 to receive 2 doses of RZV or placebo, given 1 to 2 months apart. QoL was measured by the Short Form Survey-36 and Euro-QoL-5 Dimension at baseline, 1 month, and 1 year postdose 2 and during suspected HZ episodes with the Zoster Brief Pain Inventory (ZBPI). The RZV impact on ZBPI burden of illness and burden of interference scores was estimated. The 2 scores were calculated from the area under the curve (days 0 to 182) of the ZBPI worst pain and ZBPI activities of daily living scores, respectively, assuming a score of 0 for patients not having a confirmed HZ episode. The ZBPI maximum worst pain score was significantly lower in the RZV than placebo group (mean: 5.8 versus 7.1, P = .011). Consequently, the VE estimates for HZ burden of illness (82.5%; 95% CI, 73.6 to 91.4) and burden of interference (82.8%; 95% CI, 73.3 to 92.3) were higher than the HZ VE estimate (ie, 68.2%). RZV showed significantly better QoL scores than placebo 1 week following rash onset among patients with confirmed HZ. In addition to reducing the risk of HZ and its complications, RZV significantly reduced the impact of HZ on patients' QoL in those who developed breakthrough disease.",2019,"The vaccine efficacy (VE) of a recombinant zoster vaccine (RZV) was 68.2% (95% confidence interval [CI], 55.6% to 77.5%) in a phase 3 study in adult autologous hematopoietic stem cell transplant (HSCT) recipients (NCT01610414).","['Adult Autologous Hematopoietic Stem Cell Transplant Recipients', ""patients' QoL. Autologous HSCT recipients""]","['Herpes zoster (HZ', 'RZV', 'recombinant zoster vaccine (RZV', 'placebo', 'RZV or placebo', 'HZ', 'Recombinant Zoster Vaccine', 'Placebo']","['QoL', 'quality of life (QoL', 'HZ burden of illness', 'risk of HZ', 'QoL scores', 'ZBPI maximum worst pain score', 'ZBPI worst pain and ZBPI activities of daily living scores', 'burden of interference', 'ZBPI burden of illness and burden of interference scores', 'Quality of Life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0034380'}, {'cui': 'C0162698', 'cui_str': 'Economic Burden of Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001288', 'cui_str': 'ADL'}]",,0.549255,"The vaccine efficacy (VE) of a recombinant zoster vaccine (RZV) was 68.2% (95% confidence interval [CI], 55.6% to 77.5%) in a phase 3 study in adult autologous hematopoietic stem cell transplant (HSCT) recipients (NCT01610414).","[{'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Curran', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: desmond.x.curran@gsk.com.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Matthews', 'Affiliation': 'Freelance c/o GSK, Wavre, Belgium.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Rowley', 'Affiliation': 'Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Jo-Anne H', 'Initials': 'JH', 'LastName': 'Young', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Bastidas', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Anagnostopoulos', 'Affiliation': 'Haematology Department, G. Papanikolaou General Hospital of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Barista', 'Affiliation': 'Hacettepe University Medical Faculty, Ankara, Turkey.'}, {'ForeName': 'Pranatharthi Haran', 'Initials': 'PH', 'LastName': 'Chandrasekar', 'Affiliation': 'Karmanos Cancer Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dickinson', 'Affiliation': 'Clinical Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, Victoria, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Idrissi', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Heras', 'Affiliation': 'Hospital General Universitario J. M. Morales Meseguer, Murcia, Spain.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Milliken', 'Affiliation': ""Department of Haematology, St Vincent's Hospital, Darlinghurst, New South Wales, Australia.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Monserrat Coll', 'Affiliation': 'Hospital Virgen de la Arrixaca, Murcia (El Palmar), Spain.'}, {'ForeName': 'María Belén', 'Initials': 'MB', 'LastName': 'Navarro Matilla', 'Affiliation': 'Hospital Puerta de Hierro, Majadahonda (Madrid), Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Piątkowska-Jakubas', 'Affiliation': 'Department of Haematology, Jagiellonian University Medical College, Cracow, Poland.'}, {'ForeName': 'Dimas', 'Initials': 'D', 'LastName': 'Quiel', 'Affiliation': 'Complejo Hospitalario Dr. Arnulfo Arias Madrid, Panama, Panama.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Sabry', 'Affiliation': 'Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schwartz', 'Affiliation': 'Department of Hematology and Oncology, Charité University Medical Center, Berlin, Germany.'}, {'ForeName': 'Dominik L D', 'Initials': 'DLD', 'LastName': 'Selleslag', 'Affiliation': 'Hematologie, AZ Sint-Jan Brugge-Oostende AV-Campus Sint-Jan, Brugge, Belgium.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Sullivan', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Theunissen', 'Affiliation': 'Jessa Ziekenhuis-Campus Virga Jesse, Hasselt, Belgium.'}, {'ForeName': 'Zeynep Arzu', 'Initials': 'ZA', 'LastName': 'Yegin', 'Affiliation': 'Gazi University Medical Faculty, Ankara, Turkey.'}, {'ForeName': 'Su-Peng', 'Initials': 'SP', 'LastName': 'Yeh', 'Affiliation': 'Department of Hematology, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Zaja', 'Affiliation': 'Clinica Ematologica, Azienda Ospedaliero Universitaria S. Maria Misericordia, Friuli-Venezia-Giulia, Udine, Italy.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Szer', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.07.036']
3625,31380605,Hemodialysis without anticoagulation: Less clotting in conventional hemodialysis than in predilution hemodiafiltration.,"INTRODUCTION


Hemodialysis patients with contraindication to systemic anticoagulation require a heparin-free hemodialysis technique. Among several alternatives to heparin, predilution hemodiafiltration (HDF) is often used, albeit without any confirmation of its effectiveness.
METHODS


Patients hospitalized in a nephrology ICU and hemodialysed for stage 5 CKD or AKI and with contraindication to systemic anticoagulation were randomized to either standard HD with a polysulfone membrane, or to predilution HDF with the same membrane. Coagulation activation was evaluated clinically by the need for premature termination and by the measurement of D-dimers.
FINDINGS


Two hundred dialysis sessions were performed in 155 patients. Survival curves showed better circuit survival in HD (P = 0.046). In HD, 12% of sessions were interrupted for coagulation versus 23% in predilution HDF (P = 0.04).
DISCUSSION


Predilution HDF was associated with more premature clotting than conventional HD without improvement in dialysis duration or performance epuration indices. When aiming for a 4-hour duration session, conventional heparin-free hemodialysis can be safely proposed in most patients with high bleeding risk.",2019,"DISCUSSION


Predilution HDF was associated with more premature clotting than conventional HD without improvement in dialysis duration or performance epuration indices.","['Patients hospitalized in a nephrology ICU and hemodialysed for stage 5 CKD or AKI and with contraindication to systemic anticoagulation', 'patients with high bleeding risk', 'Hemodialysis patients with contraindication to systemic anticoagulation require a']","['standard HD with a polysulfone membrane, or to predilution HDF with the same membrane', 'heparin-free hemodialysis technique', 'Hemodialysis without anticoagulation', 'heparin, predilution hemodiafiltration (HDF']","['Coagulation activation', 'circuit survival in HD', 'dialysis duration or performance epuration indices']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0441777', 'cui_str': 'Stage level 5 (qualifier value)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0137909', 'cui_str': 'polysulfone'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C2960256', 'cui_str': 'Hemodialysis technique (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}]","[{'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",200.0,0.0159138,"DISCUSSION


Predilution HDF was associated with more premature clotting than conventional HD without improvement in dialysis duration or performance epuration indices.","[{'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Krummel', 'Affiliation': 'Department of Nephrology and Dialysis, University Hospital of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Cellot', 'Affiliation': 'Department of Nephrology, General Hospital of Annecy, Annecy, France.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Thiery', 'Affiliation': 'Department of Public Health, Centre Paul Strauss, Strasbourg, France.'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'De Geyer', 'Affiliation': 'Department of Nephrology and Dialysis, University Hospital of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Keller', 'Affiliation': 'Department of Nephrology and Dialysis, University Hospital of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Hannedouche', 'Affiliation': 'Department of Nephrology and Dialysis, University Hospital of Strasbourg, Strasbourg, France.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12774']
3626,31358408,A randomized open-label trial of 2-dose or 3-dose pre-exposure rabies prophylaxis among Thai children.,"BACKGROUND


World Health Organization changed the recommendation for pre-exposure rabies prophylaxis from 3-dose to 2-dose regimen in 2018. Given limited data of 2-dose regimens in pediatric population, this study aimed to compare the immunogenicity between 2-dose and 3-dose pre-exposure rabies immunization.
METHODS


This study was conducted among healthy children aged 2-12 years. They were randomized to 2-dose vaccination (2D) on days 0 and 28 or 3-dose vaccination (3D) on days 0, 7, and 28. Purified Vero cell rabies vaccine (PVRV-Verorab™) was administered intramuscularly. Rabies virus neutralizing antibody (RVNA) titers were measured at 3 time points: 14-day after complete vaccination, 1-year pre-booster vaccination, and 7-day post-booster dose to mimic scenario of rabies exposure. RVNA titers ≥0.5 IU/ml were considered adequate antibody. T cell specific response to rabies vaccine antigen was measured using the interferon-gamma enzyme linked immunospot assay.
RESULTS


From September to October 2017, 107 participants (51% males), 78 in 2D group and 29 in 3D group were enrolled. Median age was 5.8 years (IQR 4.4-7.3). All participants had RVNA titers ≥0.5 IU/ml after primary vaccination [GMT 2D: 18.6 (95%CI 15.9-21.8) and 3D: 16.3 (95%CI 13.2-20.1 IU/ml), p = 0.35]. At 1-year prior to receiving the booster, only 80% of the children in 2D group maintained RVNA titers ≥0.5 IU/ml compared to 100% of the children in 3D group (p = 0.01). However, all participants in both groups had RVNA ≥0.5 IU/ml at 7-day post booster vaccination [GMT 2D: 20.9 (95%CI 17.4-25.3) and 3D: 22.2 (95%CI 15.8-31.4) IU/ml (P = 0.75)]. The median number of IFN-γ secreting cells at 7-day post-booster dose was 98 and 128 SFCs per 10 6  PBMCs in the 2D and 3D groups, respectively (P = 0.30).
CONCLUSIONS


Two-dose primary rabies immunization provided adequate antibody at post primary vaccination and post booster. The results support 2-dose regimen of pre-exposure rabies immunization in the pediatric population.",2019,"Rabies virus neutralizing antibody (RVNA) titers were measured at 3 time points: 14-day after complete vaccination, 1-year pre-booster vaccination, and 7-day post-booster dose to mimic scenario of rabies exposure.","['From September to October 2017, 107 participants (51% males), 78 in 2D group and 29 in 3D group were enrolled', 'healthy children aged 2-12\u202fyears', 'pediatric population', 'Thai children']","['Purified Vero cell rabies vaccine (PVRV-Verorab™', '2-dose or 3-dose pre-exposure rabies prophylaxis']","['median number of IFN-γ secreting cells', 'RVNA titers']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0042542', 'cui_str': 'Vero Cells'}, {'cui': 'C0034496', 'cui_str': 'Rabies Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1320204', 'cui_str': 'Rabies prophylaxis'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",107.0,0.148799,"Rabies virus neutralizing antibody (RVNA) titers were measured at 3 time points: 14-day after complete vaccination, 1-year pre-booster vaccination, and 7-day post-booster dose to mimic scenario of rabies exposure.","[{'ForeName': 'Pakpoom', 'Initials': 'P', 'LastName': 'Janewongwirot', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: Pakpoom.J@chula.ac.th.'}, {'ForeName': 'Watsamon', 'Initials': 'W', 'LastName': 'Jantarabenjakul', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Thai Red Cross Emerging Infectious Diseases Clinical Center (TRC-EID), King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Suvaporn', 'Initials': 'S', 'LastName': 'Anugulruengkitt', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Orawan', 'Initials': 'O', 'LastName': 'Anunsittichai', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Wachiraporn', 'Initials': 'W', 'LastName': 'Saengseesom', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Supranee', 'Initials': 'S', 'LastName': 'Buranapraditkun', 'Affiliation': 'Cellular Immunology Laboratory, Allergy and Clinical Immunology Unit, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Jiratchaya', 'Initials': 'J', 'LastName': 'Sophonphan', 'Affiliation': 'HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Noppadol', 'Initials': 'N', 'LastName': 'Wacharachaisurapol', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Nattapong', 'Initials': 'N', 'LastName': 'Jitrungruengnij', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Chitsanu', 'Initials': 'C', 'LastName': 'Pancharoen', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",Vaccine,['10.1016/j.vaccine.2019.07.055']
3627,32087257,The influence of prolonged temperature management on acute kidney injury after out-of-hospital cardiac arrest: A post hoc analysis of the TTH48 trial.,"BACKGROUND


Acute kidney injury (AKI) is common after cardiac arrest and targeted temperature management (TTM). The impact of different lengths of cooling on the development of AKI has not been well studied. In this study of patients included in a randomised controlled trial of TTM at 33 °C for 24 versus 48 h after cardiac arrest (TTH48 trial), we examined the influence of prolonged TTM on AKI and the incidence and factors associated with the development of AKI. We also examined the impact of AKI on survival.
METHODS


This study was a sub-study of the TTH48 trial, which included patients cooled to 33 ± 1 °C after out-of-hospital cardiac arrest for 24 versus 48 h. AKI was classified according to the KDIGO AKI criteria based on serum creatinine and urine output collected until ICU discharge for a maximum of seven days. Survival was followed for up to six months. The association of admission factors on AKI was analysed with multivariate analysis and the association of AKI on mortality was analysed with Cox regression using the time to AKI as a time-dependent covariate.
RESULTS


Of the 349 patients included in the study, 159 (45.5%) developed AKI. There was no significant difference in the incidence, severity or time to AKI between the 24- and 48-h groups. Serum creatinine values had significantly different trajectories for the two groups with a sharp rise occurring during rewarming. Age, time to return of spontaneous circulation, serum creatinine at admission and body mass index were independent predictors of AKI. Patients with AKI had a higher mortality than patients without AKI (hospital mortality 36.5% vs 12.5%, p < 0.001), but only AKI stages 2 and 3 were independently associated with mortality.
CONCLUSIONS


We did not find any association between prolonged TTM at 33 °C and the risk of AKI during the first seven days in the ICU. AKI is prevalent after cardiac arrest and TTM and occurs in almost half of all ICU admitted patients and more commonly in the elderly, with an increasing BMI and longer arrest duration. AKI after cardiac arrest is an independent predictor of time to death.",2020,"There was no significant difference in the incidence, severity or time to AKI between the 24- and 48-hour groups.","['TTH48 trial, which included patients cooled to 33±1˚C after out-of-hospital cardiac arrest for 24 versus 48hours', '349 patients included in the study, 159 (45.5%) developed AKI', 'acute kidney injury after out-of-hospital cardiac arrest']","['prolonged temperature management', 'TTM']","['higher mortality', 'mortality', 'Serum creatinine values', 'Survival', 'incidence, severity or time to AKI', 'Age, time to return of spontaneous circulation, serum creatinine at admission and body mass index']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",349.0,0.11476,"There was no significant difference in the incidence, severity or time to AKI between the 24- and 48-hour groups.","[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Strand', 'Affiliation': 'Department of Intensive Care, Stavanger University Hospital, Norway. Electronic address: kristian.strand@sus.no.'}, {'ForeName': 'Eldar', 'Initials': 'E', 'LastName': 'Søreide', 'Affiliation': 'Critical Care and Anaesthesiology Research Group, Stavanger University Hospital, Stavanger, Norway; Department Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kirkegaard', 'Affiliation': 'Research Centre for Emergency Medicine and Emergency Department, Aarhus University and Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Fabio Silvio', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Belgium.'}, {'ForeName': 'Anders Morten', 'Initials': 'AM', 'LastName': 'Grejs', 'Affiliation': 'Department of Intensive Care Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Christophe Henri Valdemar', 'Initials': 'CHV', 'LastName': 'Duez', 'Affiliation': 'Research Centre for Emergency Medicine and Emergency Department, Aarhus University and Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anni Nørgaard', 'Initials': 'AN', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Storm', 'Affiliation': 'Department of Internal Medicine, Nephrology and Intensive Care, Charité-University, Berlin, Germany.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Aalborg University Hospital, and Clinical Institute, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Laitio', 'Affiliation': 'Division of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku, Finland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Rigshospitalet and Dept of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Valdo', 'Initials': 'V', 'LastName': 'Toome', 'Affiliation': 'Department of Intensive Cardiac Care, North Estonia Medical Centre, Tallinn, Estonia.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Paine Medicine, University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Skrifvars', 'Affiliation': 'Department of Emergency Care and Services, Helsinki University Hospital, Finland.'}]",Resuscitation,['10.1016/j.resuscitation.2020.01.039']
3628,28925580,"Nutrition, hygiene, and stimulation education to improve growth, cognitive, language, and motor development among infants in Uganda: A cluster-randomized trial.","Stunting is associated with impaired cognitive and motor function. The effect of an education intervention including nutrition, stimulation, sanitation, and hygiene on child growth and cognitive/language/motor development, delivered to impoverished mothers in Uganda, was assessed. In a community-based, open cluster-randomized trial, 511 mother/children dyads aged 6-8 months were enrolled to an intervention (n = 263) or control (n = 248) group. The primary outcome was change in length-for-age z-score at age 20-24 months. Secondary outcomes included anthropometry and scores on the 2 developmental scales: Bayley Scales of Infant and Toddler Development-III and the Ages and Stages Questionnaire. There was no evidence of a difference in mean length-for-age z-score at 20-24 months between the 2 study groups: 0.10, 95% CI [-0.17, 0.36], p = .49. The intervention group had higher mean composite development scores than the controls on Bayley Scales of Infant and Toddler Development-III, the mean difference being 15.6, 95% CI [10.9, 20.2], p = .0001; 9.9, 95% CI [6.4, 13.2], p = .0001; and 14.6, 95% CI [10.9, 18.2], p = .0001, for cognitive, language, and motor composite scores, respectively. The mean difference in scores from the Ages and Stages Questionnaire were 7.0, 95% CI [2.9, 11.3], p = .001; 5.9, 95% CI [1.2, 10.3], p = .01; 4.2, 95% CI [1.7, 6.7], p = .001; 8.9, 95% CI [5.3, 12.3], p = .0001; and 4.4, 95% CI [0.0, 8.8], p = .05, for communication, gross motor, fine motor, problem solving, and personal-social development, respectively. The intervention education delivered to mothers promoted early development domains in cognitive, language, and motor development but not linear growth of small children in impoverished rural communities in Uganda. Our study showed that child development may be improved with a relatively low cost intervention strategy. This trial was registered at ClinicalTrials.gov as NCT02098031.",2018,"The intervention group had higher mean composite development scores than the controls on Bayley Scales of Infant and Toddler Development-III, the mean difference being 15.6, 95% CI [10.9, 20.2],","['infants in Uganda', 'small children in impoverished rural communities in Uganda', '511 mother/children dyads aged 6-8\xa0months were enrolled to an intervention (n\xa0=\xa0263) or control (n\xa0=\xa0248) group']","['intervention education delivered to mothers promoted early development domains in cognitive, language, and motor development']","['cognitive, language, and motor composite scores', 'mean length-for-age z-score', 'nutrition, stimulation, sanitation, and hygiene on child growth and cognitive/language/motor development', 'communication, gross motor, fine motor, problem solving, and personal-social development', 'Nutrition, hygiene, and stimulation education to improve growth, cognitive, language, and motor development', 'anthropometry and scores on the 2 developmental scales: Bayley Scales of Infant and Toddler Development-III and the Ages and Stages Questionnaire', 'change in length-for-age z-score', 'mean composite development scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0023008', 'cui_str': 'Languages'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0037409', 'cui_str': 'Social Development'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",511.0,0.215268,"The intervention group had higher mean composite development scores than the controls on Bayley Scales of Infant and Toddler Development-III, the mean difference being 15.6, 95% CI [10.9, 20.2],","[{'ForeName': 'Grace K M', 'Initials': 'GKM', 'LastName': 'Muhoozi', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Prudence', 'Initials': 'P', 'LastName': 'Atukunda', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lien M', 'Initials': 'LM', 'LastName': 'Diep', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mwadime', 'Affiliation': 'SPRING/Uganda (USAID Project), Kampala, Uganda.'}, {'ForeName': 'Archileo N', 'Initials': 'AN', 'LastName': 'Kaaya', 'Affiliation': 'School of Food Technology, Nutrition and Bioengineering, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Skaare', 'Affiliation': 'Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Tiril', 'Initials': 'T', 'LastName': 'Willumsen', 'Affiliation': 'Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ane C', 'Initials': 'AC', 'LastName': 'Westerberg', 'Affiliation': 'Institute of Health Sciences, Kristiania University College, Oslo, Norway.'}, {'ForeName': 'Per O', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}]",Maternal & child nutrition,['10.1111/mcn.12527']
3629,31399275,"Immunogenicity and safety of an inactivated enterovirus A71 vaccine in children 3-6 years and 2-35 months of age- an open-label, randomized phase IIb clinical trial.","BACKGROUND


Enterovirus A71 (EV-A71) infection can cause severe debilitating complications and even death in young children. The immunogenicity and safety of an inactivated whole EV-A71 virus vaccine were assessed in children 2 months to 6 years of age.
METHODS


This was an open-label, multi-center and randomized phase IIb study, which divided into part A and B. In part A, children 36 months to 6 years of age were enrolled and randomized into 3 groups, receiving 0.5 μg total viral protein (TP) with adjuvant Al(OH)3, 1.0 μg TP with Al(OH)3 or 1.0 μg TP only. Two doses of vaccines were administered at a 28-day interval and blood was taken before immunization, at week 4, 8, 28 and 52 (optional) for virus neutralization assay. Safety profiles were also monitored. After safety profiles had shown no concerns, children 2 months to 35 months of age (part B) were subsequently enrolled following the same protocol.
RESULTS


A total of 135 children completed two doses of immunization, including 58 in part A and 77 in part B. Both adjuvanted 0.5 μg and 1.0 μg TP elicited significant raise of neutralizing antibody titers and seroconversion rate was up to 93.75-100.0% after 2 doses of immunization. Adjuvanted 1.0 μg TP induced higher titers of neutralizing antibodies than adjuvanted 0.5 μg TP. By contrast, non-adjuvanted 1.0 μg TP was not immunogenic. No major adverse events were reported.
CONCLUSIONS


This EV-A71 vaccine containing adjuvant is immunogenic and safe in children 2 months to 6 years of age.
CLINICAL TRIALS REGISTRATION


NCT03268083.",2019,Adjuvanted 1.0 μg TP induced higher titers of neutralizing antibodies than adjuvanted 0.5 μg TP.,"['135 children completed two doses of immunization, including 58 in part A and 77 in part', 'young children', 'children 2\u202fmonths to 6\u202fyears of age', 'children 36\u202fmonths to 6\u202fyears of age', 'children 3-6\u202fyears and 2-35\u202fmonths of age- an open-label, randomized phase IIb clinical trial']","['inactivated whole EV-A71 virus vaccine', 'inactivated enterovirus A71 vaccine', 'receiving 0.5\u202fμg total viral protein (TP) with adjuvant Al(OH)3, 1.0\u202fμg TP with Al(OH)3 or 1.0\u202fμg TP only']","['Immunogenicity and safety', 'neutralizing antibody titers and seroconversion rate', 'immunogenicity and safety', 'higher titers of neutralizing antibodies']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0014383', 'cui_str': 'Enterovirus'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042736', 'cui_str': 'Viral Gene Products'}, {'cui': 'C0077287', 'cui_str': 'tris(acetylacetonate) aluminum(III)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",135.0,0.0535504,Adjuvanted 1.0 μg TP induced higher titers of neutralizing antibodies than adjuvanted 0.5 μg TP.,"[{'ForeName': 'Miao-Chiu', 'Initials': 'MC', 'LastName': 'Hung', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan, ROC. Electronic address: mchung@vghtpe.gov.tw.'}, {'ForeName': 'Ching-Yi', 'Initials': 'CY', 'LastName': 'Cho', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chun-Jen', 'Initials': 'CJ', 'LastName': 'Chen', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chou-Cheng', 'Initials': 'CC', 'LastName': 'Lai', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Keh-Gong', 'Initials': 'KG', 'LastName': 'Wu', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan, ROC. Electronic address: kgwu@vghtpe.gov.tw.'}]",Vaccine,['10.1016/j.vaccine.2019.07.096']
3630,30719753,Editorial Comment to Autologous platelet-rich plasma covering urethroplasty versus dartos flap in distal hypospadias repair: A prospective randomized study.,,2019,,['distal hypospadias repair'],['Autologous platelet-rich plasma covering urethroplasty versus dartos flap'],[],"[{'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra (procedure)'}, {'cui': 'C0440926', 'cui_str': 'Dartos flap (substance)'}]",[],,0.0193272,,"[{'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Nishinaka', 'Affiliation': 'Department of Pediatric Urology, Hokkaido Medical Center for Child Health and Rehabilitation, Sapporo, Hokkaido, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.13920']
3631,30439760,Probiotic Yogurt for the Prevention of Antibiotic-associated Diarrhea in Adults: A Randomized Double-blind Placebo-controlled Trial.,"GOAL


To evaluate the effect of yogurt supplemented with probiotic bacteria on the prevention of antibiotic-associated diarrhea (AAD) in hospitalized patients.
BACKGROUND


Diarrhea following antibiotic administration is a frequent clinical problem. The usefulness of probiotics for the prevention of AAD in the hospitalized adult population remains unclear.
STUDY


A randomized, double-blind, placebo-controlled clinical trial was conducted in hospitalized patients who started antibiotic treatment. Patients were randomized (2:2:1) to receive a daily amount of 200 mL of placebo-yogurt (Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus), 200 mL of probiotic yogurt (previous plus Lactobacillus acidophilus La-5, Bifidobacterium animalis subsp. lactis Bb-12 and Lactobacillus casei subsp. casei Lc-01 or no yogurt (unblinded control) within 48 hours of beginning the antibiotic therapy and up to 5 days after stopping the antibiotic. Patients were followed up with for 1 month to determine occurrence of diarrhea.
RESULTS


We included 314 patients, mean age 76 years. The rate of diarrhea was 23.0% in the probiotic group versus 17.6% in the placebo group, absolute risk reduction -5.35% (95% confidence interval, -15.4% to 4.7%; P=0.30). Rate of diarrhea was similar in the unblinded external control and in the blinded study groups combined (20.9% vs. 20.2% respectively; P=0.91). There was no difference in the duration of diarrhea, maximum number of bowel movements or prolonged admission because of diarrhea among the groups. All-cause mortality did not differ between groups.
CONCLUSIONS


The combined probiotic strains LA-5, BB-12, and LC-01 do not have an effect in the prevention of AAD in hospitalized patients.",2019,"There was no difference in the duration of diarrhea, maximum number of bowel movements or prolonged admission because of diarrhea among the groups.","['hospitalized patients', '314 patients, mean age 76 years', 'Antibiotic-associated Diarrhea in Adults', 'hospitalized patients who started antibiotic treatment']","['yogurt supplemented with probiotic bacteria', 'placebo', 'lactis Bb-12 and Lactobacillus casei subsp', 'Placebo', 'casei Lc-01 or no yogurt (unblinded control', 'placebo-yogurt (Streptococcus thermophilus and Lactobacillus delbrueckii subsp', 'probiotics', 'probiotic yogurt (previous plus Lactobacillus acidophilus La-5, Bifidobacterium animalis subsp']","['Diarrhea', 'rate of diarrhea', 'Rate of diarrhea', 'absolute risk reduction', 'diarrhea', 'antibiotic-associated diarrhea (AAD', 'duration of diarrhea, maximum number of bowel movements or prolonged admission because of diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0317588', 'cui_str': 'Lactobacillus delbrueckii'}, {'cui': 'C3853203', 'cui_str': 'Probiotic yogurt'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]",314.0,0.433502,"There was no difference in the duration of diarrhea, maximum number of bowel movements or prolonged admission because of diarrhea among the groups.","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Velasco', 'Affiliation': 'Infectious Diseases Section, Internal Medicine.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Requena', 'Affiliation': 'Department of Biotechnology and Food Microbiology, Institute of Food Science Research CIAL, Consejo Superior de Investigaciones Científicas CSIC, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Delgado-Iribarren', 'Affiliation': 'Microbiology Department, Hospital Universitario Fundación Alcorcón, Alcorcón.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Peláez', 'Affiliation': 'Department of Biotechnology and Food Microbiology, Institute of Food Science Research CIAL, Consejo Superior de Investigaciones Científicas CSIC, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Guijarro', 'Affiliation': 'Infectious Diseases Section, Internal Medicine.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001131']
3632,29576001,Impact of Metformin on IVF Outcomes in Overweight and Obese Women With Polycystic Ovary Syndrome: A Randomized Double-Blind Controlled Trial.,"OBJECTIVES


To evaluate the impact of metformin on in vitro fertilization (IVF) outcomes in overweight and obese women with polycystic ovary syndrome (PCOS).
METHODS


This was a randomized double-blind placebo-controlled study ( ClinicalTrials.gov : NCT02910817) carried out in a University IVF Center. The study included 102 overweight and obese women (body mass index [BMI] >24 kg/m 2 ) with PCOS who underwent their first fresh autologous IVF-embryo transfer cycle and agreed to participate in the study. The study participants were randomized into 2 groups: metformin group received metformin (1000 mg per day) at the start of controlled ovarian stimulation (COH) until the day of the pregnancy check, and placebo group received placebo tablets in the same duration. The primary outcome measure was the total number of retrieved oocytes.
RESULTS


Both groups were homogenous in baseline demographic characteristics. Metformin group versus the placebo group demonstrated decrease in the mean number of the retrieved oocytes (9.06 ± 4.23 vs 16.86 ± 8.3,  P  < .01) and similar live birth rate (LBR; 25.5% vs 17.6%,  P  = .34). The number of fertilized oocytes was lower in the metformin group (5.65 ± 2.66 vs 9 ± 4.55,  P  < .01). However, the fertilization rate was similar in both groups (62.3% vs 53.4%,  P  = .10). There was no difference in the implantation rate (15.7% vs 11.8%,  P  = .32), multiple pregnancy rate (13.4% vs 3.9%,  P  = .08), or miscarriage rate (23.5% vs 35.7%,  P  = .46). No cases of ovarian hyperstimulation syndrome (OHSS) were observed in both groups.
CONCLUSION


Short-term administration of metformin to overweight or obese women with PCOS undergoing IVF decreased number of the retrieved oocytes but did not improve the LBR.
SYNOPSIS


Metformin use could decrease the number of retrieved oocytes in overweight and obese women with polycystic ovary syndrome undergoing IVF.",2019,"There was no difference in the implantation rate (15.7% vs 11.8%, P = .32), multiple pregnancy rate (13.4% vs 3.9%, P = .08), or miscarriage rate (23.5% vs 35.7%, P = .46).","['overweight and obese women with polycystic ovary syndrome undergoing IVF', 'Overweight and Obese Women With Polycystic Ovary Syndrome', 'overweight and obese women with polycystic ovary syndrome (PCOS', 'University IVF Center', '102 overweight and obese women (body mass index [BMI] >24 kg/m 2 ) with PCOS who underwent their first fresh autologous IVF-embryo transfer cycle and agreed to participate in the study']","['Synopsis Metformin', 'placebo tablets', 'placebo', 'metformin', 'Metformin', 'metformin group received metformin']","['fertilization rate', 'ovarian hyperstimulation syndrome (OHSS', 'total number of retrieved oocytes', 'similar live birth rate', 'miscarriage rate', 'IVF Outcomes', 'multiple pregnancy rate', 'number of retrieved oocytes', 'implantation rate', 'number of fertilized oocytes', 'mean number of the retrieved oocytes', 'vitro fertilization (IVF) outcomes']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0085083', 'cui_str': 'Ovarian Hyperstimulation Syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0032989', 'cui_str': 'Multiple Pregnancy'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",102.0,0.520805,"There was no difference in the implantation rate (15.7% vs 11.8%, P = .32), multiple pregnancy rate (13.4% vs 3.9%, P = .08), or miscarriage rate (23.5% vs 35.7%, P = .46).","[{'ForeName': 'Osama S', 'Initials': 'OS', 'LastName': 'Abdalmageed', 'Affiliation': 'Assiut IVF center, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Tarek A', 'Initials': 'TA', 'LastName': 'Farghaly', 'Affiliation': 'Assiut IVF center, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Abdelaleem', 'Affiliation': 'Assiut IVF center, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed E', 'Initials': 'AE', 'LastName': 'Abdelmagied', 'Affiliation': 'Assiut IVF center, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohammed K', 'Initials': 'MK', 'LastName': 'Ali', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abbas', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1177/1933719118765985']
3633,31174846,Cholinergic Modulation of Exposure Disrupts Hippocampal Processes and Augments Extinction: Proof-of-Concept Study With Social Anxiety Disorder.,"BACKGROUND


In rodents, context specificity of Pavlovian extinction is attenuated by manipulations that impair hippocampal function, including systemic administration of scopolamine, a muscarinic-cholinergic receptor antagonist. Context renewal translates into return of fear following exposure therapy to feared situations. We evaluated the effectiveness of scopolamine for attenuating context renewal of phobic fear in humans.
METHODS


A total of 60 participants (35 female, 22 male, 1 transgender, 2 undeclared) with social anxiety disorder and fear of public speaking were randomized to placebo, 0.5 mg scopolamine, or 0.6 mg scopolamine. They completed seven exposure sessions in an exposure context and subsequently tested in the exposure context (extinction retest) versus a different context (context renewal test), which were counterbalanced. Testing 1 month later occurred in the exposure context (long-term extinction retest). Fear measures included skin conductance and self-reported distress during speeches. Hippocampus-dependent cognitive tasks were completed as well.
RESULTS


Scopolamine augmented extinction across exposure sessions on skin conductance response and skin conductance level. Lower skin conductance response at context renewal in scopolamine groups relative to the placebo group was constrained to simple effects and complicated by unexpected outcomes within placebo and on self-reported fear. Scopolamine led to lower skin conductance response at long-term extinction retest. Scopolamine impaired performance on a cognitive task of hippocampal function.
CONCLUSIONS


Noninvasive and well-tolerated scopolamine impaired hippocampal processes and augmented extinction during exposure. Drug-free effects persisted 1 month later. Findings at context renewal were limited and suggestive only. Further investigation is warranted with varying scopolamine dosages.",2019,Lower skin conductance response at context renewal in scopolamine groups relative to the placebo group was constrained to simple effects and complicated by unexpected outcomes within placebo and on self-reported fear.,"['phobic fear in humans', '60 participants (35 female, 22 male, 1 transgender, 2 undeclared) with social anxiety disorder and fear of public speaking']","['placebo, 0.5 mg scopolamine, or 0.6 mg scopolamine', 'placebo', 'Scopolamine', 'scopolamine']","['Lower skin conductance response', 'skin conductance and self-reported distress', 'lower skin conductance response', 'skin conductance response and skin conductance level']","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0558141', 'cui_str': 'Transsexual (finding)'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0424169', 'cui_str': 'Fear of public speaking (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",60.0,0.0385867,Lower skin conductance response at context renewal in scopolamine groups relative to the placebo group was constrained to simple effects and complicated by unexpected outcomes within placebo and on self-reported fear.,"[{'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Staglin Center for Brain and Behavioral Health, Department of Psychology, Los Angeles, California; Department of Psychiatry and Biobehavioral Sciences, University of California-Los Angeles, Los Angeles, California. Electronic address: mcraske@mednet.ucla.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fanselow', 'Affiliation': 'Staglin Center for Brain and Behavioral Health, Department of Psychology, Los Angeles, California; Department of Psychiatry and Biobehavioral Sciences, University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Treanor', 'Affiliation': 'Staglin Center for Brain and Behavioral Health, Department of Psychology, Los Angeles, California; Department of Psychiatry and Biobehavioral Sciences, University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bystritksy', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California-Los Angeles, Los Angeles, California.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.04.012']
3634,31614214,Telephone interventions for co-morbid insomnia and osteoarthritis pain: The OsteoArthritis and Therapy for Sleep (OATS) randomized trial design.,"The OsteoArthritis and Therapy for Sleep (OATS) study is a population-based randomized controlled trial of cognitive behavioral therapy for insomnia (CBTI) with four innovative methodological aims. These are to: (1) Enroll representative participants across Washington state, including those from medically underserved communities; (2) Enroll persons with persistent insomnia and chronic osteoarthritis (OA) pain; (3) Test a scalable CBT-I intervention; and (4) Evaluate patient-reported outcomes (insomnia, pain severity, fatigue, depression) and cost-effectiveness over one year. This paper describes progress towards achieving these aims. The target population was persons age 60+ who had received OA care within the Kaiser Permanente Washington (KPW) health care system. We employed a two-phase screening via mail survey and telephone follow-up, with a 3-week interval between screens to exclude persons with spontaneous improvement in sleep or pain symptoms. Participants were randomized to a 6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC). Blinded outcome assessments (completed online or on mailed paper forms) included primary and secondary sleep and pain outcome measures and quality of life measures. We obtained healthcare utilization from administrative claims data. Intent to treat analyses, including all participants randomized when they scheduled the first telephone session, will be conducted to compare CBT-I and EOC outcomes. The trial will be the largest experimental evaluation of telephone CBT-I to date, and the first to evaluate its cost-effectiveness. Trial registration: ClinicalTrials.gov identifier: NCT02946957.",2019,Participants were randomized to a 6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC).,"['co-morbid insomnia and osteoarthritis pain', 'Enroll representative participants across Washington state, including those from medically underserved communities; (2) Enroll persons with persistent insomnia and chronic osteoarthritis (OA) pain; (3', 'target population was persons age 60+ who had received OA care within the Kaiser Permanente Washington (KPW) health care system']","['6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC', 'Telephone interventions', 'cognitive behavioral therapy']","['primary and secondary sleep and pain outcome measures and quality of life measures', 'sleep or pain symptoms', 'outcomes (insomnia, pain severity, fatigue, depression) and cost-effectiveness']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0393758', 'cui_str': 'Persistent insomnia (disorder)'}, {'cui': 'C0263778', 'cui_str': 'Chronic osteoarthritis (disorder)'}, {'cui': 'C0039309', 'cui_str': 'Target Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0977968,Participants were randomized to a 6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC).,"[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'McCurry', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, WA, United States of America. Electronic address: smccurry@uw.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Von Korff', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'Department of Psychology, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cunningham', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, WA, United States of America.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Pike', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, WA, United States of America.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Thakral', 'Affiliation': 'Department of Nursing, University of Massachusetts Boston, Boston, MA, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wellman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Yeung', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Vitiello', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105851']
3635,31931160,"Efficacy of inhaled Lavandula angustifolia Mill. Essential oil on sleep quality, quality of life and metabolic control in patients with diabetes mellitus type II and insomnia.","ETHNOPHARMACOLOGIC RELEVANCE


Lavandula angustifolia Mill (lavender) odor was traditionally used as sleep enhancer. Previous studies have shown interaction between insomnia, quality of life and control of diabetes mellitus (DM). Insomnia is suggested to increase the risk of depression and decrease the quality of life in diabetic patients. The aim of this study was to evaluate the efficacy of inhaled Lavandula angustifolia Mill. as a complementary therapy for insomnia in diabetic patients.
METHODS


In a randomized crossover placebo-controlled clinical trial, 52 patients with type II diabetes mellitus (DM) and insomnia, defined as Pittsburgh Insomnia Rating Scale-20(PIRS-20)>5,were treated with inhaled lavender or placebo for two periods of 4 weeks duration with one week interval as washing period. Sleep quality, quality of life and mood status were assessed by PIRS-20, WHO Quality of Life-BREF(WHOQOL-BREF) Questionnaire and Beck Depression Inventory (BDI) scale respectively, at baseline and end of each period of study. Fasting blood glucose (FBS), calorie intake and physical activity were measured before and after the interventions.
RESULTS


At the end of study, data of 37 patients (all received both lavender and placebo in cross-over design) were analyzed. Based on crossover analysis the first treatment was not effective on the second treatment. Inhaled lavender resulted in a significant better outcome compared to placebo according to mean PIRS-20, WHOQOL-BREF and Beck Depression Inventory scores in both crossover arms. Likewise there was a significant better outcome in PIRS-20 domains for quality and quantity of sleep after Inhaled lavender compared to placebo. No significant improvement was observed in fasting glucose in lavender compared to placebo administration period.
CONCLUSION


Inhaled lavender can improve sleep quality and quantity, quality of life and mood in diabetic patients suffering from insomnia with no significant effect on metabolic status.",2020,Likewise there was a significant better outcome in PIRS-20 domains for quality and quantity of sleep after Inhaled lavender compared to placebo.,"['patients with diabetes mellitus type II and insomnia', '37 patients (all received both', '52 patients with type II diabetes mellitus (DM) and insomnia, defined as Pittsburgh Insomnia Rating Scale-20(PIRS-20)>5,were treated with', 'diabetic patients', 'diabetic patients suffering from insomnia']","['inhaled lavender or placebo', 'Inhaled lavender', 'inhaled Lavandula angustifolia Mill', 'Essential oil', 'placebo', 'lavender and placebo']","['Sleep quality, quality of life and mood status', 'Fasting blood glucose(FBS), calorie intake and physical activity', 'fasting glucose', 'Questionnaire and Beck Depression Inventory(BDI) scale', 'quality of life', 'PIRS-20 domains for quality and quantity of sleep', 'mean PIRS-20, WHOQOL-BREF and Beck Depression Inventory scores', 'PIRS-20, WHO Quality of Life-BREF(WHOQOL-BREF', 'safety and efficacy', 'sleep quality and quantity, quality of life and mood', 'sleep quality, quality of life and metabolic control']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0222045'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1623196', 'cui_str': 'Lavandula angustifolia'}, {'cui': 'C0599997', 'cui_str': 'Mill (environment)'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",52.0,0.0638379,Likewise there was a significant better outcome in PIRS-20 domains for quality and quantity of sleep after Inhaled lavender compared to placebo.,"[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Nasiri Lari', 'Affiliation': 'Department of Traditional Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran; Essence of Parsiyan Wisdom Institute, Traditional Medicine and Medicinal Plant Incubator, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahdie', 'Initials': 'M', 'LastName': 'Hajimonfarednejad', 'Affiliation': 'Department of Traditional Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran; Essence of Parsiyan Wisdom Institute, Traditional Medicine and Medicinal Plant Incubator, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryamsadat', 'Initials': 'M', 'LastName': 'Riasatian', 'Affiliation': 'Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Abolhassanzadeh', 'Affiliation': 'Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Iraji', 'Affiliation': 'Central Research Laboratory, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Vojoud', 'Affiliation': 'Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Heydari', 'Affiliation': 'Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mesbah', 'Initials': 'M', 'LastName': 'Shams', 'Affiliation': 'Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: shams@sums.ac.ir.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.112560']
3636,30704933,A Frontline Approach With Peripherally Inserted Versus Centrally Inserted Central Venous Catheters for Remission Induction Chemotherapy Phase of Acute Myeloid Leukemia: A Randomized Comparison.,"BACKGROUND


The incidence of peripherally inserted central catheter (PICC)-related adverse events has been uncertain in the setting of acute myeloid leukemia (AML) compared with the incidence of centrally inserted central catheter (CICC) adverse events.
PATIENTS AND METHODS


We conducted a monocentric, randomized trial of patients with previously untreated AML. Of the 93 patients, 46 had received a PICC and 47 had received a CICC as frontline intravascular device. Thereafter, all patients underwent intensive chemotherapy for hematologic remission induction. The primary endpoint was catheter-related (CR)-bloodstream infection (BSI) and venous thrombosis (VT) rate. The secondary endpoints catheter malfunction, catheter removal, and patient overall survival.
RESULTS


The CR-BSI and CR-VT rate in the PICC and CICC groups was 13% and 49%, respectively, with a difference of 36 percentage points (relative risk for CR-BSI or CR-VT, 0.266; P = .0003). The CR-BSI incidence was 1.4 and 7.8 per 1000 catheters daily in the PICC and CICC groups, respectively. Among the CR thromboses, the symptomatic VT rate was 2.1% in the PICC group and 10.6% in the CICC group. In the CICC group, 16 of the 47 patients (34%) had the catheter removed for BSI (n = 5), septic thrombophlebitis (n = 4), VT (n = 2), or malfunction (n = 5) a median of 7 days after insertion. In the PICC group, only 6 of the 46 patients (13%) required catheter removal for VT (n = 2) or malfunction (n = 4). At a median follow-up of 30 days, 6 patients in the CICC group died of CR complications versus none of the patients in the PICC group (P = .012). Using PICCs, the reduction in BSI and symptomatic VT decreased mortality from CR infection and venous thromboembolism. In contrast, the CICC approach led to early catheter removal mostly for difficult-to-treat infectious pathogens.
CONCLUSION


Our data have confirmed that BSI and symptomatic VT are the major complications affecting frontline central intravascular device-related morbidity in the leukemia setting. The use of a PICC is safer than that of a CICC and maintains the effectiveness for patients with AML undergoing chemotherapy, with an approximate fourfold lower combined risk of infection or thrombosis at 30 days.",2019,The primary endpoint was catheter-related (CR)-bloodstream infection (BSI) and venous thrombosis (VT) rate.,"['93 patients, 46 had received a PICC and 47 had received a', 'Acute Myeloid Leukemia', 'patients with previously untreated AML', 'patients with AML undergoing']","['Peripherally Inserted Versus Centrally Inserted Central Venous Catheters', 'chemotherapy', 'intensive chemotherapy', 'CICC', 'PICC']","['CR-BSI and CR-VT rate', 'catheter removal', 'CR-BSI incidence', 'hematologic remission induction', 'died of CR complications', 'septic thrombophlebitis', 'symptomatic VT rate', 'catheter-related (CR)-bloodstream infection (BSI) and venous thrombosis (VT) rate', 'secondary endpoints catheter malfunction, catheter removal, and patient overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C1145640', 'cui_str': 'Central Venous Catheters'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0394884', 'cui_str': 'Removal of catheter (procedure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0035052', 'cui_str': 'Remission Induction'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0740341', 'cui_str': 'Septic thrombophlebitis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.129003,The primary endpoint was catheter-related (CR)-bloodstream infection (BSI) and venous thrombosis (VT) rate.,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Picardi', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University Medical School, Naples, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Della Pepa', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cerchione', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Italy.'}, {'ForeName': 'Novella', 'Initials': 'N', 'LastName': 'Pugliese', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Italy. Electronic address: novypugliese@yahoo.it.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Mortaruolo', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Trastulli', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Giordano', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Grimaldi', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Zacheo', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Raimondo', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Chiurazzi', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Pane', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Italy.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2018.12.008']
3637,30721997,The Effects of Recombinant Human Lactoferrin on Immune Activation and the Intestinal Microbiome Among Persons Living with Human Immunodeficiency Virus and Receiving Antiretroviral Therapy.,"Lactoferrin modulates mucosal immunity and targets mechanisms contributing to inflammation during human immunodeficiency virus disease. A randomized placebo-controlled crossover clinical trial of recombinant human (rh) lactoferrin was conducted among 54 human immunodeficiency virus-infected participants with viral suppression. Outcomes were tolerability, inflammatory, and immunologic measures, and the intestinal microbiome. The median age was 51 years, and the median CD4+ cell count was 651/µL. Adherence and adverse events did not differ between rh-lactoferrin and placebo. There was no significant effect on plasma interleukin-6 or D-dimer levels, nor on monocyte/T-cell activation, mucosal integrity, or intestinal microbiota diversity. Oral administration of rh-lactoferrin was safe but did not reduce inflammation and immune activation. Clinical Trials Registration: NCT01830595.",2019,"There was no significant effect on plasma interleukin-6 or D-dimer levels, nor on monocyte/T-cell activation, mucosal integrity, or intestinal microbiota diversity.","['human immunodeficiency virus disease', '54 human immunodeficiency virus-infected participants with viral suppression', 'Persons Living with Human Immunodeficiency Virus and Receiving Antiretroviral Therapy']","['placebo', 'rh-lactoferrin', 'Lactoferrin', 'Recombinant Human Lactoferrin', 'recombinant human (rh) lactoferrin']","['tolerability, inflammatory, and immunologic measures, and the intestinal microbiome', 'Immune Activation and the Intestinal Microbiome', 'median CD4+ cell count was 651/µL. Adherence and adverse events', 'plasma interleukin-6 or D-dimer levels, nor on monocyte/T-cell activation, mucosal integrity, or intestinal microbiota diversity', 'inflammation and immune activation']","[{'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",54.0,0.107784,"There was no significant effect on plasma interleukin-6 or D-dimer levels, nor on monocyte/T-cell activation, mucosal integrity, or intestinal microbiota diversity.","[{'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Sortino', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.'}, {'ForeName': 'Kathy Huppler', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'Leidos Biomedical Research, Frederick, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Richards', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Rupert', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Minnesota.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schminke', 'Affiliation': 'Hennepin Healthcare Research Institute, Minneapolis.'}, {'ForeName': 'Namo', 'Initials': 'N', 'LastName': 'Tetekpor', 'Affiliation': 'Hennepin Healthcare Research Institute, Minneapolis.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Quinones', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Prosser', 'Affiliation': 'Hennepin Healthcare Research Institute, Minneapolis.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schacker', 'Affiliation': 'Leidos Biomedical Research, Frederick, Maryland.'}, {'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Sereti', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.'}, {'ForeName': 'Jason V', 'Initials': 'JV', 'LastName': 'Baker', 'Affiliation': 'Leidos Biomedical Research, Frederick, Maryland.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz042']
3638,31517759,Effects of a Physical Therapist Led Workplace Personal-Fitness Management Program for Manufacturing Industry Workers: A Randomized Controlled Trial.,"OBJECTIVE


Workplace fitness programs are used to improve worker physical capacity. We aimed to evaluate the effectiveness of physical therapist (PT) led personal-fitness management programs (PP) on manufacturing worker physical performance assessed using a 30-second chair stand (CS-30) test.
METHODS


This assessor-blinded, randomized controlled trial enrolled 60 manufacturing workers allocated to a workplace PP group (PPG) or control group (CG). The PPG received monthly, PT managed, individualized PP for 6 months. The CG received a 90-minute group-fitness management course once during the study period.
RESULTS


CS-30 significantly improved in both groups (PPG and CG, P < 0.001) following the intervention. There were significant group-time interaction effects, and the PPG experienced a significantly greater improvement in CS-30 results compared with CG (P < 0.001).
CONCLUSIONS


Individualized PT-led workplace PP may be more effective in improving worker physical performance.",2019,"CS-30 significantly improved in both groups (PPG and CG, P < 0.001) following the intervention.","['60 manufacturing workers', 'Manufacturing Industry Workers']","['physical therapist (PT) led personal-fitness management programs (PP', 'workplace PP group (PPG) or control group (CG', 'Physical Therapist Led Workplace Personal-Fitness Management Program']","['CS-30 results', 'worker physical performance', 'CS-30', 'time interaction effects']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0021267', 'cui_str': 'Industry'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C2607857'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",60.0,0.0822112,"CS-30 significantly improved in both groups (PPG and CG, P < 0.001) following the intervention.","[{'ForeName': 'Ryutaro', 'Initials': 'R', 'LastName': 'Matsugaki', 'Affiliation': 'Graduate School of Medical Science, University of Occupational and Environmental Health (Mr Matsugaki); Rehabilitation Center, University Hospital of Occupational and Environmental Health (Mr Matsugaki); Renesas Electronics Corporation, Oita Factory, Oita (Ms Sakata); Department of Rehabilitation Medicine (Dr Itoh, Dr Matsushima, Dr Saeki), University of Occupational and Environmental Health, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Sakata', 'Affiliation': ''}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': ''}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Matsushima', 'Affiliation': ''}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saeki', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001712']
3639,31525422,"Electrospun P(LLA-CL) Nanoscale Fibrinogen Patch vs Porcine Small Intestine Submucosa Graft Repair of Inguinal Hernia in Adults: A Randomized, Single-Blind, Controlled, Multicenter, Noninferiority Trial.","BACKGROUND


The aim of this study was to compare primary efficacy indicators of a low-cost, electrospun, nanoscale P(LLA-CL)/fibrinogen patch with a porcine small intestine submucosa patch for hernia repair.
STUDY DESIGN


A randomized, single-blind, controlled multicenter trial was performed in 3 hospitals in Shanghai. Eligible patients (20 to 75 years old) with primary unilateral, reducible groin hernias were randomly assigned (1:1) to electrospun nanoscale P(LLA-CL)/fibrinogen patch (experimental group) or porcine small intestine submucosa (control group) patch groups. Patients were treated with the Lichtenstein technique, and the primary endpoint was hernia recurrence at 33 months after surgery. The secondary endpoints were postoperative complications including groin pain and operative site infections.
RESULTS


Between July 2014 and February 2016, 172 patients were assigned to experimental (n = 86) and control (n = 86) groups. At 6-month follow-up, postoperative complications occurred in 5 patients (5 of 86, 5.81%) and 2 (2 of 86, 2.35%) patients in the control and experimental groups, respectively (p < 0.05). At 33-month follow-up, recurrence was observed in 2 patients (2 of 79, 2.53%) in the control group vs none in the experimental group (0 of 78) (the 95% CI difference between the experimental and control groups was -0.93% to 6.00% and within the preset noninferior margin of Δ10%). No significant differences were found in the degree of chronic pain and complications 33 months after surgery between the 2 groups.
CONCLUSIONS


Because the recurrence rates and postoperative complications after 33 months were not inferior in the experimental group, we believe that the P(LLA-CL)/fibrinogen patch, as a low cost alternative, has prospects for widespread clinical use.",2019,"At 33 months follow-up, recurrence was observed in 2 patients (2/79, 2·53%) in the control group vs none in the experimental group (0/78) (the 95% CI difference between the experimental and control groups was -0·93-6·00% and within the preset non-inferior margin of Δ10%).","['Between July 2014 and February 2016, 172 patients were assigned to experimental (n = 86) and control (n = 86) groups', 'Eligible patients (20-75 years old) with primary unilateral reducible groin hernias', 'of Inguinal Hernia in Adults', '3 hospitals in Shanghai']","['Electrospun P(LLA-CL', 'electrospun nanoscale P(LLA-CL)/fibrinogen patch (experimental group) or porcine small intestine submucosa (control group) patch groups', 'low-cost, electrospun, nanoscale P(LLA-CL)/fibrinogen patch with a porcine small intestine submucosa patch', 'Lichtenstein technique', 'Nanoscale Fibrinogen Patch vs Porcine Small Intestine Submucosa Graft Repair']","['recurrence rates and postoperative complications', 'degree of chronic pain and complications', 'postoperative complications', 'recurrence', 'hernia recurrence', 'postoperative complications including groin pain and operative site infections']","[{'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0205337', 'cui_str': 'Reducible (qualifier value)'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0227268', 'cui_str': 'Small intestine submucosa (body structure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain (finding)'}, {'cui': 'C0332850', 'cui_str': 'Operative site (morphologic abnormality)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",172.0,0.104384,"At 33 months follow-up, recurrence was observed in 2 patients (2/79, 2·53%) in the control group vs none in the experimental group (0/78) (the 95% CI difference between the experimental and control groups was -0·93-6·00% and within the preset non-inferior margin of Δ10%).","[{'ForeName': 'Shaojie', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Surgery, Huadong Hospital, affiliated with Fudan University, Shanghai, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': ""Department of Surgery, Tenth People's Hospital of Tongji University, Shanghai, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'P&P Biotech Co, Ltd, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Hua', 'Affiliation': 'Department of Surgery, Putuo Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Qiu', 'Affiliation': 'Ultrasound Department, Huadong Hospital, affiliated with Fudan University, Shanghai, China.'}, {'ForeName': 'Xingchen', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Surgery, Huadong Hospital, affiliated with Fudan University, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Ping', 'Affiliation': ""Department of Surgery, Tenth People's Hospital of Tongji University, Shanghai, China.""}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Zheng', 'Affiliation': 'Department of Surgery, Putuo Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'P&P Biotech Co, Ltd, Shanghai, China; Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiangxiong', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Surgery, Huadong Hospital, affiliated with Fudan University, Shanghai, China. Electronic address: johnxiong@china.com.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2019.08.1446']
3640,30761530,Post-extubation continuous positive airway pressure improves oxygenation after pediatric laparoscopic surgery: A randomized controlled trial.,"BACKGROUND


Effects of intraoperative recruitment maneuvers (RMs) on oxygenation and pulmonary compliance are lost during recovery if high inspired oxygen and airway suctioning are used. We investigated the effect of post-extubation noninvasive CPAP mask application on the alveolar arterial oxygen difference [(A-a) DO 2  ] after pediatric laparoscopic surgery.
METHODS


Sixty patients (1-6 years) were randomly allocated to three groups of 20 patients, to receive zero end-expiratory pressure (ZEEP group), RM with decremental PEEP titration only (RM group), or followed with post-extubation CPAP for 5 minutes (RM-CPAP group). Primary outcome was [(A-a) DO 2  ] at 1 hour postoperatively. Secondary outcomes were respiratory mechanics, arterial blood gas analysis, hemodynamics, and adverse events.
RESULTS


At 1 hour postoperatively, mean [(A-a) DO 2  ] (mm Hg) was lower in the RM-CPAP group (41.5 ± 13.2, [95% CI 37.6-45.8]) compared to (80.2 ± 13.7 [72.6-87.5], P < 0.0001] and (59.2 ± 14.6, [54.8-62.6], P < 0.001) in the ZEEP and RM groups. The mean PaO 2  (mm Hg) at 1 hour postoperatively was higher in the RM-CPAP group (156.2 ± 18.3 [95% CI 147.6-164.7]) compared with the ZEEP (95.9 ± 15.9 [88.5-103.3], P < 0.0001) and RM groups (129.1 ± 15.9 [121.6-136.5], P < 0.0001). At 12 hours postoperatively, mean [(A-a) DO 2  ] and PaO 2  were (9.6 ± 2.1 [8.4-10.8]) and (91.9 ± 9.4 [87.5-96.3]) in the RM-CPAP group compared to (25.8 ± 5.5 [23.6-27.6]) and (69.9 ± 5.5 [67.4-72.5], P < 0.0001) in the ZEEP group and (34.3 ± 13.2, [28.4-40.2], P < 0.0001) and (74.03 ± 9.8 [69.5-78.6], P < 0.0001) in the RM group. No significant differences of perioperative adverse effects were found between groups.
CONCLUSIONS


An RM done after pneumoperitoneum inflation followed by decremental PEEP titration improved oxygenation at 1 hour postoperatively. The addition of an early post-extubation noninvasive CPAP mask ventilation improved oxygenation at 12 hours postoperatively.",2019,"No significant differences of perioperative adverse effects were found between groups.
","['pediatric laparoscopic surgery', 'Sixty patients (1-6\xa0years']","['intraoperative recruitment maneuvers (RMs', 'post-extubation noninvasive CPAP mask application', 'zero end-expiratory pressure (ZEEP group), RM with decremental PEEP titration only (RM group), or followed with post-extubation CPAP', 'ZEEP']","['perioperative adverse effects', 'mean PaO 2', 'respiratory mechanics, arterial blood gas analysis, hemodynamics, and adverse events']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0428720', 'cui_str': 'End-expiratory pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.487076,"No significant differences of perioperative adverse effects were found between groups.
","[{'ForeName': 'Hala S', 'Initials': 'HS', 'LastName': 'Abdel-Ghaffar', 'Affiliation': 'Anesthesia and Intensive Care Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Hamdy A', 'Initials': 'HA', 'LastName': 'Youseff', 'Affiliation': 'Anesthesia and Intensive Care Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Fatma A', 'Initials': 'FA', 'LastName': 'Abdelal', 'Affiliation': 'Anesthesia and Intensive Care Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Osman', 'Affiliation': 'Pediatric Surgery Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Jehan A', 'Initials': 'JA', 'LastName': 'Sayed', 'Affiliation': 'Anesthesia and Intensive Care Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed Amir Fathy', 'Initials': 'MAF', 'LastName': 'Riad', 'Affiliation': 'Pediatrics Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Marwa M', 'Initials': 'MM', 'LastName': 'Abdel-Rady', 'Affiliation': 'Anesthesia and Intensive Care Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13324']
3641,30958543,Immunogenicity and Safety of a Sabin Strain-Based Inactivated Polio Vaccine: A Phase 3 Clinical Trial.,"BACKGROUND


The Sabin strain-based inactivated polio vaccine (sIPV) plays a vital role in eradicating poliomyelitis in developing countries.
METHODS


The study was designed as a randomized, controlled, double-blinded, noninferiority trial. A total of 1200 healthy infants aged 60-90 days were enrolled and randomly assigned to receive 3 doses of either sIPV (the experimental arm) or IPV (the control arm) at days 0, 30, and 60. Immunogenicity and safety outcomes were assessed using the per-protocol and safety populations, respectively.
RESULTS


A total of 553 and 562 participants in the sIPV and IPV groups, respectively, were included in the per-protocol population. Seroconversion rates in the sIPV and IPV groups were 98.0% and 94.1%, respectively, for type 1 poliovirus (P < .01); 94.8% and 84.0%, respectively, for type 2 (P < .01); and 98.9% and 97.7%, respectively, for type 3 (P = .11). A total of 599 and 600 participants in the sIPV and IPV groups, respectively, were included in the safety population. Fever was the most common adverse event, occurring in 61.6% and 49.8% of participants in the experimental and control arms, respectively (P < .01).
CONCLUSIONS


The sIPV demonstrated an immunogenicity profile noninferior to that of the conventional IPV and had a good safety profile.
CLINICAL TRIALS REGISTRATION


NCT03526978.",2019,"The sIPV demonstrated an immunogenicity profile noninferior to that of the conventional IPV and had a good safety profile.
","['A total of 553 and 562 participants in the sIPV and IPV groups, respectively, were included in the per-protocol population', 'A total of 599 and 600 participants in the sIPV and IPV groups, respectively, were included in the safety population', '1200 healthy infants aged 60-90 days']","['Sabin strain-based inactivated polio vaccine (sIPV', 'Sabin Strain-Based Inactivated Polio Vaccine', 'IPV', 'sIPV']","['Immunogenicity and Safety', 'Seroconversion rates', 'Immunogenicity and safety outcomes']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",1200.0,0.508302,"The sIPV demonstrated an immunogenicity profile noninferior to that of the conventional IPV and had a good safety profile.
","[{'ForeName': 'Yuemei', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Vaccine Evaluation, Nanjing.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Sinovac Biotech, Beijing.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Department of Clinical Research, Sinovac Biotech, Beijing.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Department of Vaccine Evaluation, Nanjing.'}, {'ForeName': 'Deyu', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Center of Research and Development, Sinovac Biotech, Beijing.'}, {'ForeName': 'Fengdong', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Guanyun County Center for Disease Control and Prevention, Guanyun.'}, {'ForeName': 'Zhifang', 'Initials': 'Z', 'LastName': 'Ying', 'Affiliation': 'Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Sinovac Biotech, Beijing.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Pizhou County Center for Disease Control and Prevention, Pizhou, China.'}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Sinovac Biotech, Beijing.'}, {'ForeName': 'Fengcai', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Office of the Deputy Director, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'Office of the General Manager, Sinovac Biotech, Beijing.'}]",The Journal of infectious diseases,['10.1093/infdis/jiy736']
3642,31721327,"Safety and efficacy of topical, fixed-dose combination calcipotriene (0.005%) and betamethasone (0.064% as dipropionate) gel in adolescent patients with scalp and body psoriasis: a phase II trial.","BACKGROUND


Psoriasis is a disease that commonly manifests in adolescence. Up to half of adults with psoriasis develop it before the age of 20. Topical formulations containing corticosteroids and/or vitamin D3 analogs are recommended for treatment.
OBJECTIVE


This phase II study aimed to evaluate the safety, including any potential effect on the hypothalamic-pituitary-adrenal axis and calcium metabolism, and efficacy of fixed-dose combination calcipotriene (0.005%) and betamethasone (0.064% as dipropionate) (Cal/BD) gel in adolescents with psoriasis.
METHODS


Patients aged 12 to <17 years, with at least mild psoriasis on the body and scalp, received topical Cal/BD gel once daily for ≤8 weeks. Safety response criteria included adverse drug reactions [ADRs; any adverse event (AE) possibly or probably related to treatment as determined by the investigator; a primary response criterion] and AEs (a secondary response criterion). Only treatment-emergent AEs (events that occurred after the first application of Cal/BD gel or events which started before this and increased in intensity after the first application of Cal/BD gel) are presented here. Efficacy response criteria included controlled disease, by physician's global assessment of disease severity (PGA), following Cal/BD gel treatment.
RESULTS


A total of 107 patients (median age 14 years; range 12-16) were enrolled and treated. Eight ADRs were observed in 7 (7%) patients and 38 (36%) patients experienced ≥1 AE. The most common AEs were headache [6 (6%) patients], nasopharyngitis [6 (6%) patients] and blood parathyroid hormone increased [4 (4%) patients]. One severe AE was reported (attempted suicide) but was considered unrelated to treatment. At the end of treatment, 58% of patients had controlled disease on the body and 69% on the scalp according to PGA.
CONCLUSION


In this uncontrolled phase II study, Cal/BD gel was well tolerated and effective for treating scalp and body psoriasis in adolescents.",2020,"At the end of treatment, 58% of patients had controlled disease on the body and 69% on the scalp according to PGA","['adolescents', 'adolescents with psoriasis', '107 patients (median age 14 years; range 12-16', 'adolescent patients with scalp and body psoriasis', 'Patients aged 12 to <17 years, with at least mild psoriasis on the body and scalp received', 'once daily for ≤8 weeks']","['topical, fixed-dose combination calcipotriene', 'dipropionate', 'Cal/BD gel', 'PGA', 'corticosteroids and/or vitamin D3 analogs', 'betamethasone', 'fixed-dose combination calcipotriene', 'dipropionate) gel', 'topical Cal/BD gel']","['adverse drug reactions (ADRs; any adverse event [AE', 'Safety and efficacy', 'Eight ADRs', 'nasopharyngitis', 'headache', 'tolerated and effective', 'blood parathyroid hormone']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0065767', 'cui_str': 'calcipotriol'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}]","[{'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0853132', 'cui_str': 'Blood parathyroid hormone'}]",107.0,0.0384445,"At the end of treatment, 58% of patients had controlled disease on the body and 69% on the scalp according to PGA","[{'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': ""University of California, San Diego and Rady Children's Hospital, San Diego, CA, USA.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Marcoux', 'Affiliation': 'Sainte-Justine University Hospital Center, Montreal, QC, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kurvits', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Liljedahl', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16077']
3643,30975567,An ODE-based mixed modelling approach for B- and T-cell dynamics induced by Varicella-Zoster Virus vaccines in adults shows higher T-cell proliferation with Shingrix than with Varilrix.,"Clinical trials covering the immunogenicity of a vaccine aim to study the longitudinal dynamics of certain immune cells after vaccination. The corresponding immunogenicity datasets are mainly analyzed by the use of statistical (mixed effects) models. This paper proposes the use of mathematical ordinary differential equation (ODE) models, combined with a mixed effects approach. ODE models are capable of translating underlying immunological post vaccination processes into mathematical formulas thereby enabling a testable data analysis. Mixed models include both population-averaged parameters (fixed effects) and individual-specific parameters (random effects) for dealing with inter- and intra-individual variability, respectively. This paper models B-cell and T-cell datasets of a phase I/II, open-label, randomized, parallel-group study (NCT00492648) in which the immunogenicity of a new Herpes Zoster vaccine (Shingrix) is compared with the original Varicella Zoster Virus vaccine (Varilrix). Since few significant correlations were found between the B-cell and T-cell datasets, each dataset was modeled separately. By following a general approach to both the formulation of several different models and the procedure of selecting the most suitable model, we were able to propose a mathematical ODE mixed-effects model for each dataset. As such, the use of ODE-based mixed effects models offers a suitable framework for handling longitudinal vaccine immunogenicity data. Moreover, this approach allows testing for differences in immunological processes between vaccines or schedules. We found that the Shingrix vaccination schedule led to a more pronounced proliferation of T-cells, without a difference in T-cell decay rate compared to the Varilrix vaccination schedule.",2019,"We found that the Shingrix vaccination schedule led to a more pronounced proliferation of T-cells, without a difference in T-cell decay rate compared to the Varilrix vaccination schedule.",[],['new Herpes Zoster vaccine (Shingrix'],"['proliferation of T-cells', 'T-cell decay rate']",[],"[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C4530100', 'cui_str': 'Shingrix'}]","[{'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C1265875', 'cui_str': 'Disintegration'}]",,0.025461,"We found that the Shingrix vaccination schedule led to a more pronounced proliferation of T-cells, without a difference in T-cell decay rate compared to the Varilrix vaccination schedule.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Keersmaekers', 'Affiliation': 'Centre for Health Economics Research & Modeling Infectious Diseases (CHERMID), Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium; Antwerp Unit for Data Analysis and Computation in Immunology and Sequencing (AUDACIS), University of Antwerp, Antwerp, Belgium. Electronic address: nina.keersmaekers@uantwerp.be.'}, {'ForeName': 'Benson', 'Initials': 'B', 'LastName': 'Ogunjimi', 'Affiliation': 'Centre for Health Economics Research & Modeling Infectious Diseases (CHERMID), Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium; Antwerp Unit for Data Analysis and Computation in Immunology and Sequencing (AUDACIS), University of Antwerp, Antwerp, Belgium; Antwerp Center for Translational Immunology and Virology (ACTIV), Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium; Department of Paediatrics, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Van Damme', 'Affiliation': 'Antwerp Unit for Data Analysis and Computation in Immunology and Sequencing (AUDACIS), University of Antwerp, Antwerp, Belgium; Centre for the Evaluation of Vaccination (CEV), Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Beutels', 'Affiliation': 'Centre for Health Economics Research & Modeling Infectious Diseases (CHERMID), Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium; Antwerp Unit for Data Analysis and Computation in Immunology and Sequencing (AUDACIS), University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Niel', 'Initials': 'N', 'LastName': 'Hens', 'Affiliation': 'Centre for Health Economics Research & Modeling Infectious Diseases (CHERMID), Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium; Antwerp Unit for Data Analysis and Computation in Immunology and Sequencing (AUDACIS), University of Antwerp, Antwerp, Belgium; Interuniversity Institute for Biostatistics and statistical Bioinformatics, Hasselt University, Diepenbeek, Belgium.'}]",Vaccine,['10.1016/j.vaccine.2019.03.075']
3644,31495592,Phase 1 trial of a 20-valent pneumococcal conjugate vaccine in healthy adults.,"INTRODUCTION


Streptococcus pneumoniae is a leading cause of bacteremia, bacterial pneumonia, and meningitis, and is associated with substantial morbidity and mortality, particularly in those under 2 years of age and those over 65 years of age. While significant progress against S. pneumoniae-related disease has been made as a result of the introduction of pneumococcal conjugate vaccines (PCV7, PCV10 and PCV13), there remains value in further expanding pneumococcal vaccine serotype coverage. Here we present the first report of a 20-valent pneumococcal conjugate vaccine (PCV20) containing capsular polysaccharide conjugates present in PCV13 as well as 7 new serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) which are important contributors to pneumococcal disease.
METHODS


This Phase I first-in-human study was a randomized, controlled, observer-blinded study with a two-arm parallel design to assess the safety, tolerability, and immunogenicity of PCV20 in adults. A total of 66 healthy adults 18-49 years of age with no history of pneumococcal vaccination were enrolled and randomized to receive a single dose of PCV20 or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) control. Local injection site reactions, select systemic symptoms, laboratory studies, and adverse events were assessed. Opsonophagocytic activity (OPA) titers and IgG concentrations were measured in sera collected prior to, and approximately one month (28-35 days) after vaccination.
RESULTS


Vaccination with PCV20 elicited substantial IgG and functional bactericidal immune responses as demonstrated by increases in IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) to the 20 vaccine serotypes. The overall safety profile of PCV20 was similar to Tdap, and generally consistent with that observed after PCV13 administration.
CONCLUSIONS


Vaccination with PCV20 was well tolerated and induced substantial functional (OPA) and IgG responses to all vaccine serotypes. There were no safety issues identified in this Phase 1 study, and the data supported further evaluation of PCV20.",2019,"RESULTS


Vaccination with PCV20 elicited substantial IgG and functional bactericidal immune responses as demonstrated by increases in IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) to the 20 vaccine serotypes.","['adults', 'healthy adults', 'those under 2\u202fyears of age and those over 65\u202fyears of age', '66 healthy adults 18-49\u202fyears of age with no history of pneumococcal vaccination']","['PCV20', 'PCV20 or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) control', '20-valent pneumococcal conjugate vaccine', '20-valent pneumococcal conjugate vaccine (PCV20']","['tolerated and induced substantial functional (OPA) and IgG responses', 'overall safety profile of PCV20', 'IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs', 'Opsonophagocytic activity (OPA) titers and IgG concentrations', 'safety, tolerability, and immunogenicity of PCV20']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0419707', 'cui_str': 'Pneumococcal vaccination (procedure)'}]","[{'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0206253', 'cui_str': 'Vaccines, Combination'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}]","[{'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",66.0,0.216656,"RESULTS


Vaccination with PCV20 elicited substantial IgG and functional bactericidal immune responses as demonstrated by increases in IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) to the 20 vaccine serotypes.","[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Pearl River, NY, United States.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lamberth', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Collegeville, PA, United States. Electronic address: Erik.Lamberth@Pfizer.com.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Severs', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Pearl River, NY, United States.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Scully', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Pearl River, NY, United States.'}, {'ForeName': 'Sanela', 'Initials': 'S', 'LastName': 'Tarabar', 'Affiliation': 'Pfizer Clinical Research Unit, Pfizer, Inc., New Haven, CT, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ginis', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Collegeville, PA, United States.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Pearl River, NY, United States.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Pearl River, NY, United States.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Scott', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Collegeville, PA, United States.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Watson', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Collegeville, PA, United States.'}]",Vaccine,['10.1016/j.vaccine.2019.08.048']
3645,31343945,Aortic diastolic pressure decay modulates relation between worsened aortic stiffness and myocardial oxygen supply/demand balance after resistance exercise.,"High-intensity resistance exercise (RE) increases aortic stiffness and decreases the index of myocardial oxygen supply/demand balance (Buckberg index, BI); there is a correlation between the changes in these parameters. Central hemodynamics during diastole can explain the correlation. We aimed to investigate whether the aortic diastolic decay index mediates the association between changes in aortic stiffness and BI by high-intensity RE. We evaluated the effect of high-intensity RE on aortic stiffness, BI, aortic decay index, and their associations in 52 young men. Subjects were studied under parallel experimental conditions on two separate days. The order of experiments was randomized between RE (5 sets of 10 repetitions at 75% of 1-repetition maximum) and sham control (seated rest). Aortic pulse wave velocity (PWV; index of aortic stiffness), BI, and aortic decay index were measured in all subjects. Aortic decay index was quantified by fitting an exponential curve: P( t ) = P 0 e -λ t  (where λ is decay index, P 0  is end-systolic pressure and  t  is time from end-systole). Aortic PWV and decay index increased and BI decreased after RE. RE conditions showed that change in the aortic decay index was associated with changes in aortic PWV and changes in aortic PWV were related to changes in BI, although the PWV-BI relationship was not significant after accounting for decay index change. Mediation analysis revealed the mediating effect of the aortic decay index on the relationship between changes in aortic PWV and BI. The present findings suggest that high-intensity RE-induced aortic stiffening worsens myocardial viability by accelerating aortic diastolic exponential decay. NEW & NOTEWORTHY  Aortic pulse wave velocity (PWV) and diastolic decay index increased and Buckberg index (BI) decreased after resistance exercise (RE). Mediation analysis revealed a mediating effect of aortic decay index on the relationship between changes in aortic PWV and BI. The present study provides evidence that high-intensity RE-induced aortic stiffening accelerates aortic decay and aortic decay can account for the relationship between aortic stiffening and a deteriorated surrogate marker of myocardial oxygen supply/demand balance induced by high-intensity RE.",2019,Aortic PWV and decay index increased and BI decreased after RE.,['52 young men'],"['high-intensity RE', 'High-intensity resistance exercise (RE']","['Aortic PWV and decay index increased and BI', 'aortic stiffness, BI, aortic decay index', 'aortic decay index', 'aortic stiffness and decreases index of myocardial oxygen supply/demand balance (Buckberg index, BI', 'aortic PWV, and changes in aortic PWV', 'Aortic pulse wave velocity (PWV; index of aortic stiffness), BI, and aortic decay index', 'Aortic decay index']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C1265875', 'cui_str': 'Disintegration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}]",52.0,0.0185146,Aortic PWV and decay index increased and BI decreased after RE.,"[{'ForeName': 'Kaname', 'Initials': 'K', 'LastName': 'Tagawa', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Akari', 'Initials': 'A', 'LastName': 'Takahashi', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Atsumu', 'Initials': 'A', 'LastName': 'Yokota', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Tomohito', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Maeda', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00117.2019']
3646,30707771,Effect of Monthly High-Dose Vitamin D on Mental Health in Older Adults: Secondary Analysis of a RCT.,"OBJECTIVES


To test the effect of monthly high-dose vitamin D supplementation on mental health in pre-frail older adults.
DESIGN


Ancillary study of a 1-year double-blind randomized clinical trial conducted in Zurich, Switzerland.
SETTING AND PARTICIPANTS


A total of 200 community-dwelling adults 70 years and older with a prior fall event in the last year. Participants were randomized to receive 24 000 IU vitamin D 3  (considered standard of care), 60 000 IU vitamin D 3  , or 24 000 IU vitamin D 3  plus 300 μg calcifediol per month.
MEASURES


The primary end point was the Mental Component Summary (MCS) of the SF-36. Secondary end points were the SF-36 Mental Health (MH) subscale and the Geriatric Depression Scale (GDS-15).
RESULTS


Participants' mean age was 78 years (67% women), and 58% were vitamin D deficient (<20 ng/mL). Over time, primary and secondary end points did not differ significantly among the three treatment groups or in subgroups by vitamin D status at baseline. Given the lack of a true placebo group, we explored in a predefined observational analysis the change in mental health scales by achieved 25(OH)D levels at 12 months. After adjusting for confounders, participants achieving the highest 25(OH)D quartile (Q) at 12 months (44.7-98.9 ng/mL) had the greatest improvements in MCS (Q4 = 0.79 vs Q1 = -2.9; p = .03) and MH scales (Q4 = 2.54 vs Q1 = -3.07; p = .03); these associations were strongest among participants who were vitamin D deficient at baseline. No association was found for GDS (p = .89).
CONCLUSIONS


For mental health, our study suggests no benefit of higher monthly doses of vitamin D 3  compared with the standard monthly dose of 24 000 IU. However, irrespective of vitamin D treatment dose, achieving higher 25(OH)D levels at 12-month follow-up was associated with a small, clinically uncertain but statistically significant improvement in mental health scores.",2019,"Over time, primary and secondary end points did not differ significantly among the three treatment groups or in subgroups by vitamin D status at baseline.","[""Participants' mean age was 78\u2009years (67% women"", 'A total of 200 community-dwelling adults 70\u2009years and older with a prior fall event in the last year', 'pre-frail older adults', 'Older Adults']","['vitamin D', 'vitamin D supplementation', 'placebo', 'vitamin D 3  plus 300\u2009μg calcifediol per month', '24 000\u2009IU vitamin D 3  (considered standard of care', 'Monthly High-Dose Vitamin D']","['Mental Health', 'SF-36 Mental Health (MH) subscale and the Geriatric Depression Scale (GDS-15', 'mental health', '25(OH)D levels', 'Mental Component Summary (MCS) of the SF-36', 'MCS', 'MH scales', 'mental health scores', 'mental health scales']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",200.0,0.580412,"Over time, primary and secondary end points did not differ significantly among the three treatment groups or in subgroups by vitamin D status at baseline.","[{'ForeName': 'Alenka', 'Initials': 'A', 'LastName': 'Gugger', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Marzel', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': 'Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Willett', 'Affiliation': 'Departments of Nutrition and Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Theiler', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Freystätter', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Egli', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland.'}, {'ForeName': 'Heike A', 'Initials': 'HA', 'LastName': 'Bischoff-Ferrari', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15808']
3647,30738171,"GBR 830, an anti-OX40, improves skin gene signatures and clinical scores in patients with atopic dermatitis.","BACKGROUND


GBR 830 is a humanized mAb against OX40, a costimulatory receptor on activated T cells. OX40 inhibition might have a therapeutic role in T cell-mediated diseases, including atopic dermatitis (AD).
OBJECTIVE


This exploratory phase 2a study investigated the safety, efficacy, and tissue effects of GBR 830 in patients with AD.
METHODS


Patients with moderate-to-severe AD (affected body surface area, ≥10%; Eczema Area and Severity Index score, ≥12; and inadequate response to topical treatments) were randomized 3:1 to 10 mg/kg intravenous GBR 830 or placebo on day 1 (baseline) and day 29. Biopsy specimens were collected (n = 40) at days 1, 29, and 71. Primary end points included treatment-emergent adverse events (TEAEs) and changes from baseline in biomarkers (epidermal hyperplasia/cytokines) at days 29 and 71.
RESULTS


GBR 830 was well tolerated, with equal TEAE distribution (GBR 830, 63.0% [29/46]; placebo, 63.0% [10/16]). One serious TEAE in the GBR 830 group was deemed unrelated to study drug. At day 71, the proportion of intent-to-treat subjects achieving 50% or greater improvement in Eczema Area and Severity Index score was greater with GBR 830 (76.9% [20/26]) versus placebo (37.5% [3/8]). GBR 830 induced significant progressive reductions in T H 1 (IFN-γ/CXCL10), T H 2 (IL-31/CCL11/CCL17), and T H 17/T H 22 (IL-23p19/IL-8/S100A12) mRNA expression in lesional skin. Significant progressive reductions until day 71 in the drug group were seen in OX40 +  T cells and OX40L +  dendritic cells (P < .001). Hyperplasia measures (thickness/keratin 16/Ki67) showed greater reductions with GBR 830 (P < .001).
CONCLUSIONS


Two doses of GBR 830 administered 4 weeks apart were well tolerated and induced significant progressive tissue and clinical changes until day 71 (42 days after the last dose), highlighting the potential of OX40 targeting in patients with AD.",2019,"Hyperplasia measures (thickness/keratin 16/Ki67) showed greater reductions with GBR 830 (P < .001).
","['Patients with moderate-to-severe AD (affected body surface area, ≥10%; Eczema Area and Severity Index score, ≥12; and inadequate response to topical treatments', 'patients with atopic dermatitis', 'patients with AD']","['intravenous GBR 830 or placebo', 'placebo', 'GBR']","['safety, efficacy, and tissue effects', 'OX40 +  T cells and OX40L +  dendritic cells', 'tolerated and induced significant progressive tissue and clinical changes', 'progressive reductions in T H 1 (IFN-γ/CXCL10), T H 2 (IL-31/CCL11/CCL17), and T H 17/T H 22 (IL-23p19/IL-8/S100A12) mRNA expression in lesional skin', 'treatment-emergent adverse events (TEAEs) and changes from baseline in biomarkers (epidermal hyperplasia/cytokines', 'Hyperplasia measures', 'skin gene signatures and clinical scores', 'Eczema Area and Severity Index score', 'Significant progressive reductions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4517889', 'cui_str': '830 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0011306', 'cui_str': 'Dendritic Cells'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1311140', 'cui_str': 'IL-23p19'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C4019423', 'cui_str': 'ENRAGE Protein'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",830.0,0.309132,"Hyperplasia measures (thickness/keratin 16/Ki67) showed greater reductions with GBR 830 (P < .001).
","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: emma.guttman@mountsinai.org.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Pavel', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Yeriel D', 'Initials': 'YD', 'LastName': 'Estrada', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Huei-Chi', 'Initials': 'HC', 'LastName': 'Wen', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Panayiota', 'Initials': 'P', 'LastName': 'Govas', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Gudi', 'Affiliation': 'Glenmark Pharmaceuticals, Inc, Paramus, NJ.'}, {'ForeName': 'Vinu', 'Initials': 'V', 'LastName': 'Ca', 'Affiliation': 'Glenmark Pharmaceuticals, Ltd, Mumbai, India.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'Glenmark Pharmaceuticals, Inc, Paramus, NJ.'}, {'ForeName': 'Yacine', 'Initials': 'Y', 'LastName': 'Salhi', 'Affiliation': 'Glenmark Pharmaceuticals, Inc, Paramus, NJ.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Back', 'Affiliation': 'Glenmark Pharmaceuticals, SA, La Chaux-de-Fonds, Switzerland.'}, {'ForeName': 'Venkateshwar', 'Initials': 'V', 'LastName': 'Reddy', 'Affiliation': 'Glenmark Pharmaceuticals, Inc, Paramus, NJ.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Inovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'Inovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Grossman', 'Affiliation': 'Glenmark Pharmaceuticals, Inc, Paramus, NJ.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Wolff', 'Affiliation': 'Glenmark Pharmaceuticals, Inc, Paramus, NJ.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2018.11.053']
3648,31082689,Comment on 'Randomised phase 2 study of pembrolizumab plus CC-486 versus pembrolizumab plus placebo in patients with previously treated advanced non-small cell lung cancer'-No support for de-escalation of immunotherapy.,,2019,,"[""patients with previously treated advanced non-small cell lung cancer'-No support for de-escalation of immunotherapy""]",['pembrolizumab plus CC-486 versus pembrolizumab plus placebo'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0621534,,"[{'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Georgiou', 'Affiliation': 'The Royal Marsden Hospital Foundation Trust, UK. Electronic address: a.georgiou@nhs.net.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Minchom', 'Affiliation': 'The Royal Marsden Hospital Foundation Trust, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""O'Brien"", 'Affiliation': 'The Royal Marsden Hospital Foundation Trust, UK.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.04.011']
3649,30829117,Robot-assisted gait training is not superior to intensive overground walking in multiple sclerosis with severe disability (the RAGTIME study): A randomized controlled trial.,"BACKGROUND


Rehabilitation may attenuate the impact on mobility of patients with progressive multiple sclerosis (MS) and severe gait disabilities.
OBJECTIVE


In this randomized controlled trial, we compared robot-assisted gait training (RAGT) with conventional therapy (CT) in terms of gait speed, mobility, balance, fatigue and quality of life (QoL).
METHODS


Seventy-two patients with MS (expanded disability status scale score 6.0-7.0) were randomized to receive 12 training sessions over a 4-week period of RAGT ( n  = 36) or overground walking therapy ( n  = 36). The primary outcome was gait speed, assessed by the timed 25-foot walk test. Secondary outcome measures were walking endurance, balance, depression, fatigue and QoL. Tests were performed at baseline, intermediate, at the end of treatment and at a 3-month follow-up.
RESULTS


Sixty-six patients completed the treatments. At the end of treatment with respect to baseline, both groups significantly improved gait speed ( p  < 0.001) and most secondary outcomes without between-group differences. Outcome values returned to baseline at follow-up.
CONCLUSIONS


RAGT was not superior to CT in improving gait speed in patients with progressive MS and severe gait disabilities where a positive, even transitory, effect of rehabilitation was observed.",2020,"At the end of treatment with respect to baseline, both groups significantly improved gait speed ( p < 0.001) and most secondary outcomes without between-group differences.","['patients with progressive multiple sclerosis (MS) and severe gait disabilities', '\n\n\nSeventy-two patients with MS (expanded disability status scale score 6.0-7.0', 'multiple sclerosis with severe disability']","['12 training sessions over a 4-week period of RAGT ( n\u2009=\u200936) or overground walking therapy', 'robot-assisted gait training (RAGT) with conventional therapy (CT', 'RAGT', 'CT', 'Robot-assisted gait training']","['gait speed, mobility, balance, fatigue and quality of life (QoL', 'walking endurance, balance, depression, fatigue and QoL. Tests', 'gait speed, assessed by the timed 25-foot walk test', 'gait speed', 'severe gait disabilities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",72.0,0.102542,"At the end of treatment with respect to baseline, both groups significantly improved gait speed ( p < 0.001) and most secondary outcomes without between-group differences.","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, Ferrara, Italy/ Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Martinuzzi', 'Affiliation': 'Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Maietti', 'Affiliation': 'Center for Clinical Epidemiology, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, Ferrara, Italy/ Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519833901']
3650,31375378,Cost-effectiveness of coronary artery bypass grafting plus mitral valve repair versus coronary artery bypass grafting alone for moderate ischemic mitral regurgitation.,"OBJECTIVE


The Cardiothoracic Surgical Trials Network reported that left ventricular reverse remodeling at 2 years did not differ between patients with moderate ischemic mitral regurgitation randomized to coronary artery bypass grafting plus mitral valve repair (n = 150) or coronary artery bypass grafting alone (n = 151). To address health resource use implications, we compared costs and quality-adjusted survival.
METHODS


We used individual patient data from the Cardiothoracic Surgical Trials Network trial on survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years. A microsimulation model was developed to extrapolate to 10 years. Bootstrap and deterministic sensitivity analyses were performed to address uncertainty.
RESULTS


In-hospital costs were $59,745 for coronary artery bypass grafting plus mitral valve repair versus $51,326 for coronary artery bypass grafting alone (difference $8419; 95% uncertainty interval, 2259-18,757). Two-year costs were $81,263 versus $67,341 (difference 13,922 [2370 to 28,888]), and quality-adjusted life years were 1.35 versus 1.30 (difference 0.05; -0.04 to 0.14), resulting in an incremental cost-effectiveness ratio of $308,343/quality-adjusted life year for coronary artery bypass grafting plus mitral valve repair. At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [-3866 to 56,826]) and quality-adjusted life years showed no difference (-0.92 to 0.87), with 5.08 versus 5.08. The likelihood that coronary artery bypass grafting plus mitral valve repair would be considered cost-effective at 10 years based on a cost-effectiveness threshold of $100K/quality-adjusted life year did not exceed 37%. Only when this procedure reduces the death rate by a relative 5% will the incremental cost-effectiveness ratio fall below $100K/quality-adjusted life year.
CONCLUSIONS


The addition of mitral valve repair to coronary artery bypass grafting for patients with moderate ischemic mitral regurgitation is unlikely to be cost-effective. Only if late mortality benefits can be demonstrated will it meet commonly used cost-effectiveness criteria.",2020,"At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [-3866 to 56,826]) and quality-adjusted life years showed no difference (-0.92 to 0.87), with 5.08 versus 5.08.","['patients with moderate ischemic mitral regurgitation randomized to', 'patients with moderate ischemic mitral regurgitation', 'moderate ischemic mitral regurgitation']","['coronary artery bypass grafting plus mitral valve repair', 'coronary artery bypass grafting plus mitral valve\xa0repair (n\xa0=\xa0150) or coronary artery bypass grafting alone', 'mitral valve repair to coronary artery bypass grafting', 'coronary artery bypass grafting alone', 'coronary artery bypass grafting plus mitral valve repair versus coronary artery bypass grafting alone']","['Cost-effectiveness', 'costs and quality-adjusted survival', 'death rate', 'survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years', 'quality-adjusted life years', 'incremental cost-effectiveness ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4087284', 'cui_str': 'Ischaemic mitral regurgitation'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0396849', 'cui_str': 'Repair of mitral valve (procedure)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0034380'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0789585,"At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [-3866 to 56,826]) and quality-adjusted life years showed no difference (-0.92 to 0.87), with 5.08 versus 5.08.","[{'ForeName': 'Bart S', 'Initials': 'BS', 'LastName': 'Ferket', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'Department of Cardiac Surgery, MedStar Heart & Vascular Institute, Washington, DC; Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Ga.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Voisine', 'Affiliation': 'Institut Universitaire de Cardiologie et Pneumonologie de Québec, Hôpital Laval, Québec, Quebec, Canada.'}, {'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Hohmann', 'Affiliation': 'Center for Advanced Analytics, Vizient, Chicago, Ill.'}, {'ForeName': 'Helena L', 'Initials': 'HL', 'LastName': 'Chang', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Smith', 'Affiliation': 'Department of Surgery, Division of Cardiovascular and Thoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Michler', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY.'}, {'ForeName': 'Gorav', 'Initials': 'G', 'LastName': 'Ailawadi', 'Affiliation': 'Division of Thoracic and Cardiovascular Surgery, University of Virginia School of Medicine, Charlottesville, Va.'}, {'ForeName': 'Louis P', 'Initials': 'LP', 'LastName': 'Perrault', 'Affiliation': 'Montréal Heart Institute, University of Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Marissa A', 'Initials': 'MA', 'LastName': 'Miller', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Md.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': ""O'Sullivan"", 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Mick', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Bagiella', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Acker', 'Affiliation': 'Department of Surgery, Division of Cardiovascular Surgery, University of Pennsylvania School of Medicine, Philadelphia, Pa.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Moquete', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Judy W', 'Initials': 'JW', 'LastName': 'Hung', 'Affiliation': 'Division of Cardiology, Massachusetts General Hospital, Boston, Mass.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Overbey', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Iraola', 'Affiliation': 'Cardiovascular Services, Suburban Hospital of Johns Hopkins Medicine, Bethesda, Md.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Gammie', 'Affiliation': 'Department of Surgery, Division of Cardiac Surgery, University of Maryland Medical Center, Baltimore, Md.'}, {'ForeName': 'Annetine C', 'Initials': 'AC', 'LastName': 'Gelijns', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: annetine.gelijns@mssm.edu.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': ""O'Gara"", 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Moskowitz', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.06.040']
3651,30796054,Modified Goldmann prism intraocular pressure measurement accuracy and correlation to corneal biomechanical metrics: multicentre randomised clinical trial.,"PURPOSE


Clinically evaluate intraocular pressure (IOP) measurements taken with a Goldmann applanation tonometer (GAT) prism and a modified surface Goldmann prism examining measurement differences correlated to central corneal thickness (CCT) and corneal hysteresis (CH) values.
DESIGN


Prospective, open-label, randomised, controlled, multicentre reference device accuracy analysis.
METHODS


A GAT and a modified surface GAT prism measured IOP on 243 unique eyes. The study design and methodology complied with International Standard Organization (ISO) tonometer evaluation guidelines, except the inclusion of thin (<500 µm) and thick (>600 µm) corneas. All eyes were randomised to IOP measurement by one of five standard Goldmann prisms and five modified prisms. Pressures were measured by six investigators, two times with each prism for a total of 1936 IOP measurements. Analysis included a multiple linear regression including CCT and CH correlation.
RESULTS


The difference in IOP measurements of the standard and modified Goldmann prisms correlated well to CCT particularly in thin (<500 µm) and thick (>600 µm) corneas (R 2 =0.404, p=0.007). Corneal hysteresis (CH) also significantly correlated to the difference in prism measurements (R 2 =0.125, p=0.039). There was no significant overall mean IOP bias between the two prisms (+0.43 mm Hg in modified, p=0.19).
DISCUSSION


The paired IOP measurement difference between GAT and a modified surface Goldmann replacement prism indicated a statistically significant correlation to CCT and CH. A simple modified replacement prism for any Goldmann-type tonometer may significantly improve IOP measurement accuracy by minimising corneal biomechanical errors associated with CCT and CH.
TRIAL REGISTRATION NUMBER


NCT02990169 and NCT02989909.",2019,"The difference in IOP measurements of the standard and modified Goldmann prisms correlated well to CCT particularly in thin (<500 µm) and thick (>600 µm) corneas (R 2 =0.404, p=0.007).",['243 unique eyes'],"['modified surface GAT prism measured IOP', 'Goldmann applanation tonometer (GAT) prism']","['central corneal thickness (CCT) and corneal hysteresis (CH) values', 'corneal biomechanical metrics', 'intraocular pressure (IOP) measurements', 'Corneal hysteresis (CH', 'overall mean IOP bias', 'IOP measurement accuracy', 'IOP measurements']","[{'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0124604', 'cui_str': 'Miraa'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]",1936.0,0.146695,"The difference in IOP measurements of the standard and modified Goldmann prisms correlated well to CCT particularly in thin (<500 µm) and thick (>600 µm) corneas (R 2 =0.404, p=0.007).","[{'ForeName': 'Sean Joseph', 'Initials': 'SJ', 'LastName': 'McCafferty', 'Affiliation': 'Arizona Eye Consultants, Tucson, Arizona, USA sjmccafferty66@hotmail.com.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Tetrault', 'Affiliation': 'Arizona Eye Consultants, Tucson, Arizona, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'McColgin', 'Affiliation': 'Arizona Eye Consultants, Tucson, Arizona, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Chue', 'Affiliation': 'Arizona Eye Consultants, Tucson, Arizona, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Levine', 'Affiliation': 'Arizona Eye Consultants, Tucson, Arizona, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Muller', 'Affiliation': 'Arizona Eye Consultants, Tucson, Arizona, USA.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313470']
3652,30839428,Time for change: an experimental investigation of chronic pain patients' emotional and attitudinal responses to simulated opioid-tapering advice.,"Clinicians report reluctance to deliver opioid-tapering advice to patients with chronic pain, in part due to concerns that patients will be angry and dissatisfied. An experiment was conducted to examine chronic pain patients' emotional and attitudinal responses to simulated opioid-tapering advice. Patients scheduled for an initial assessment at a tertiary pain clinic and currently taking opioid medications for pain (N = 196) were randomly assigned to view video footage of a standardized patient receiving 1 of 3 forms of treatment advice: (1) stay on current medication (2) change to a different pain medication, or (3) taper off pain medications and participate in a CBT-based pain self-management program. Participants reported how positive/enthusiastic, anxious/worried, and angry/irritable they felt in response to the simulated treatment advice, and how satisfied with and willing they would be to accept and follow the advice. Participants expressed more positive emotional and attitudinal responses to simulated opioid-tapering advice than to simulated opioid-maintenance advice. Furthermore, participants' responses to simulated opioid-tapering and opioid-change advice were not significantly different, suggesting that participants responded positively to the prospect of change in treatment strategy. Additional analyses revealed that participants with a longer history of chronic pain and opioid use responded less positively to simulated opioid-tapering advice. The results of this study contribute to our understanding of factors that may shape chronic pain patients' responses to opioid-tapering advice and suggest that patients may respond more positively to opioid-tapering advice if it is presented together with an alternative treatment approach.",2019,Participants expressed more positive emotional and attitudinal responses to simulated opioid-tapering advice than to simulated opioid-maintenance advice.,"['chronic pain patients', 'Patients scheduled for an initial assessment at a tertiary pain clinic and currently taking opioid medications for pain (N = 196']","['simulated opioid-tapering advice', 'opioid-tapering advice', 'view video footage of a standardized patient receiving 1 of 3 forms of treatment advice: (1) stay on current medication (2) change to a different pain medication, or (3) taper off pain medications and participate in a CBT-based pain self-management program']","['positive emotional and attitudinal responses', ""chronic pain patients' emotional and attitudinal responses"", 'emotional and attitudinal responses']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0242936', 'cui_str': 'Pain Centers'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517625', 'cui_str': '196'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",196.0,0.031286,Participants expressed more positive emotional and attitudinal responses to simulated opioid-tapering advice than to simulated opioid-maintenance advice.,"[{'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Ashton-James', 'Affiliation': ''}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Chemke-Dreyfus', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Glare', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000001543']
3653,30928442,Pre-Dilatation Versus No Pre-Dilatation for Implantation of a Self-Expanding Valve in All Comers Undergoing TAVR: The DIRECT Trial.,"OBJECTIVES


The aim of this study was to compare the implantation of a self-expanding valve with or without balloon aortic valvuloplasty (BAV) in an open-label, noninferiority, randomized trial.
BACKGROUND


There are no randomized studies comparing the implantation of a self-expanding valve with (pre-BAV) or without BAV.
METHODS


Consecutive patients with severe aortic stenosis were randomly assigned to undergo transcatheter aortic valve replacement with the use of self-expanding prostheses with (pre-BAV) or without (no-BAV) pre-dilatation. The primary endpoint was device success according to the Valve Academic Research Consortium 2 criteria. Secondary endpoints included periprocedural mortality and stroke, new permanent pacemaker implantation, vascular complications, and 1-year mortality. The trial was scheduled to show noninferiority (Δ = 15%) of the direct versus the pre-BAV approach.
RESULTS


A total of 171 patients were randomized at 4 centers. Of these, 86 underwent transcatheter aortic valve replacement with pre-dilatation and 85 without. Device success was noninferior in the no-BAV group compared with the pre-BAV group (65 of 85 [76.5%] for no-BAV vs. 64 of 86 [74.4%] for pre-BAV; mean difference 2.1%; 90% confidence interval: -8.9% to 13%). In the no-BAV group, 25 patients (29.4%) underwent post-balloon dilatation, and in the pre-BAV group, 13 patients (15.1%) underwent post-balloon dilatation (p = 0.03). Regarding major vascular complications and permanent pacemaker implantation, there was no difference between the 2 groups (log-rank p = 0.49, log-rank p = 0.54). In 1-month completed follow-up for all patients, there was 1 periprocedural stroke (0.5%), without any deaths.
CONCLUSIONS


Direct, without balloon pre-dilatation, transcatheter aortic valve replacement with a self-expanding prosthesis system is noninferior to the pre-dilatation procedure. Lower post-dilatation rates were encountered in the group with pre-dilatation. (The Predilatation in Transcatheter Aortic Valve Implantation Trial [DIRECT]; NCT02448927).",2019,"Regarding major vascular complications and permanent pacemaker implantation, there was no difference between the 2 groups (log-rank p = 0.49, log-rank p = 0.54).","['171 patients were randomized at 4 centers', 'Consecutive patients with severe aortic stenosis']","['TAVR', 'transcatheter aortic valve replacement with pre-dilatation', 'Pre-Dilatation Versus No Pre-Dilatation', 'self-expanding valve with or without balloon aortic valvuloplasty (BAV', 'transcatheter aortic valve replacement with the use of self-expanding prostheses with (pre-BAV) or without (no-BAV) pre-dilatation', 'BAV']","['periprocedural mortality and stroke, new permanent pacemaker implantation, vascular complications, and 1-year mortality', 'periprocedural stroke', 'Device success', 'Lower post-dilatation rates', 'device success']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0396949', 'cui_str': 'Valvuloplasty of aortic valve (procedure)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]",171.0,0.107858,"Regarding major vascular complications and permanent pacemaker implantation, there was no difference between the 2 groups (log-rank p = 0.49, log-rank p = 0.54).","[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Toutouzas', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece. Electronic address: ktoutouz@gmail.com.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Benetos', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'Vasilis', 'Initials': 'V', 'LastName': 'Voudris', 'Affiliation': 'Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Drakopoulou', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Stathogiannis', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Latsios', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Synetos', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Antonopoulos', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kosmas', 'Affiliation': 'Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Iakovou', 'Affiliation': 'Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Katsimagklis', 'Affiliation': 'Naval Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Mastrokostopoulos', 'Affiliation': 'Naval Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Sotiris', 'Initials': 'S', 'LastName': 'Moraitis', 'Affiliation': 'Naval Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Zeniou', 'Affiliation': 'Heart Institute, Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Haim', 'Initials': 'H', 'LastName': 'Danenberg', 'Affiliation': 'Heart Institute, Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Manolis', 'Initials': 'M', 'LastName': 'Vavuranakis', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Tousoulis', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.02.005']
3654,31725362,Low-load blood flow restriction training induces similar morphological and mechanical Achilles tendon adaptations compared with high-load resistance training.,"Low-load blood flow restriction (LL-BFR) training has gained increasing interest in the scientific community by demonstrating that increases in muscle mass and strength are comparable to conventional high-load (HL) resistance training. Although adaptations on the muscular level are well documented, there is little evidence on how LL-BFR training affects human myotendinous properties. Therefore, the aim of the present study was to investigate morphological and mechanical Achilles tendon adaptations after 14 wk of strength training. Fifty-five male volunteers (27.9 ± 5.1 yr) were randomly allocated into the following three groups: LL-BFR [20-35% of one-repetition maximum (1RM)], HL (70-85% 1RM), or a nonexercising control (CON) group. The LL-BFR and HL groups completed a resistance training program for 14 wk, and tendon morphology, mechanical as well as material properties, and muscle cross-sectional area (CSA) and isometric strength were assessed before and after the intervention. Both HL (+40.7%) and LL-BFR (+36.1%) training induced significant increases in tendon stiffness ( P  < 0.05) as well as tendon CSA (HL: +4.6%, LL-BFR: +7.8%,  P  < 0.001). These changes were comparable between groups without significant changes in Young's modulus. Furthermore, gastrocnemius medialis muscle CSA and plantar flexor strength significantly increased in both training groups ( P  < 0.05), whereas the CON group did not show significant changes in any of the evaluated parameters. In conclusion, the adaptive change in Achilles tendon properties following low-load resistance training with partial vascular occlusion appears comparable to that evoked by high-load resistance training. NEW & NOTEWORTHY  Low-load blood flow restriction (LL-BFR) training has been shown to induce beneficial adaptations at the muscular level. However, studies examining the effects on human tendon properties are rare. The findings provide first evidence that LL-BFR can increase Achilles tendon mechanical and morphological properties to a similar extent as conventional high-load resistance training. This is of particular importance for individuals who may not tolerate heavy training loads but still aim for improvements in myotendinous function.",2019,"Furthermore, gastrocnemius medialis muscle CSA and plantar flexor strength significantly increased in both training groups ( p  < 0.05), while the CON group did not show significant changes in any of the evaluated parameters.",['Fifty-five male volunteers (27.9 ± 5.1 years'],"['strength training', 'Low-load blood flow restriction training', 'HL (70-85% 1RM) or a non-exercising control group (CON', 'LL-BFR', 'Low-load blood flow restriction (LL-BFR) training', 'CON']","['tendon stiffness', 'LL-BFR', 'Furthermore, gastrocnemius medialis muscle CSA and plantar flexor strength']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042950', 'cui_str': 'Will'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0042950', 'cui_str': 'Will'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}]",55.0,0.0158298,"Furthermore, gastrocnemius medialis muscle CSA and plantar flexor strength significantly increased in both training groups ( p  < 0.05), while the CON group did not show significant changes in any of the evaluated parameters.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Centner', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Lauber', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Olivier R', 'Initials': 'OR', 'LastName': 'Seynnes', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Jerger', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Sohnius', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Gollhofer', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'König', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg, Germany.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00602.2019']
3655,31758850,Achieving the composite end-point of glycated hemoglobin <7.0% without weight gain or hypoglycemia with once-weekly dulaglutide in Chinese patients with type 2 diabetes: A post-hoc analysis.,"AIMS/INTRODUCTION


To assess the effect of dulaglutide (DU) 1.5/0.75 mg in comparison with glimepiride (GLIM) or insulin glargine (GLAR) on the composite end-point in Chinese type 2 diabetes patients.
MATERIALS AND METHODS


Post-hoc analyses of two randomized phase III trials (NCT01644500 and NCT01648582) were carried out using Fisher's exact test. The primary composite end-point was the number of patients reaching glycated hemoglobin (HbA1c) <7.0%, without weight gain and hypoglycemia. Secondary composite end-points included the number of patients reaching HbA1c <7.0% without weight gain and HbA1c <7.0% without hypoglycemia.
RESULTS


Data of 1,147 Chinese type 2 diabetes patients were analyzed (NCT01644500 = 556; NCT01648582 = 591). In each analyzed trial, 40-48% of patients received DU (1.5 mg), 30-39% of patients received DU (0.75 mg) and 15-20% of patients on active comparators (GLIM/GLAR) reached the primary composite end-point at week 26 (P < 0.001 for DU vs GLIM/GLAR). At 52 weeks, 26% of patients that received DU (1.5 mg), 23% of patients that received DU (0.75 mg) and 7% of patients that received GLAR attained the primary composite end-point (P < 0.001 for DU vs GLAR). A similar trend of results was found for secondary composite end-points.
CONCLUSIONS


Dulaglutide is found to be an effective therapeutic alternative for Chinese type 2 diabetes patients. Compared with GLIM/GLAR, significantly greater proportions of patients on DU attained the HbA1c target of <7.0% without weight gain or hypoglycemia.",2020,"Compared to GLIM/GLAR, significantly greater proportions of patients on DU attained the HbA1c target of less than 7.0% without WG or hypoglycemia.","['Chinese T2D patients', 'Chinese patients with type 2 diabetes', 'Chinese type 2 diabetes (T2D) patients', '1147 Chinese T2D patients']","['GLIM/GLAR', 'dulaglutide (DU', 'GLAR', 'glimepiride (GLIM) or insulin glargine (GLAR']","['number of patients reaching HbA1c less', 'weight gain (WG), and hypoglycemia', 'hypoglycemia']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",1147.0,0.0576304,"Compared to GLIM/GLAR, significantly greater proportions of patients on DU attained the HbA1c target of less than 7.0% without WG or hypoglycemia.","[{'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Endocrinology, Key Laboratory of Endocrinology, National Health Commission, Chinese Academy of Medical Science, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Changjiang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The First Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Lai', 'Affiliation': 'The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': 'Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Clinical Research Physician, Diabetes Therapeutic Area, Eli Lilly and Company, Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Institute of Metabolism and Endocrinology, Key Laboratory of Diabetes Immunology, Ministry of Education, National Clinical Research Center for Metabolic Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}]",Journal of diabetes investigation,['10.1111/jdi.13187']
3656,31363925,"Psychological treatments for depression among women experiencing intimate partner violence: findings from a randomized controlled trial for behavioral activation in Goa, India.","Intimate partner violence (IPV) strongly predicts depression, but it is unknown if women experiencing IPV can benefit from depression treatments in contexts where depression and IPV are prevalent. This study explored whether women experiencing IPV in Goa, India, can benefit from the Healthy Activity Program (HAP), a culturally adapted behavioral activation treatment, compared with enhanced usual care (EUC). Cross-sectional and longitudinal analyses were performed on data from a clinical trial. Measures assessed at baseline and 3 and 12 months included depressive symptoms. Measures assessed at 3 and 12 months included activation and IPV. Independent t tests were conducted to assess if participants experiencing IPV had higher depressive symptoms and lower activation at 3 and 12 months; hierarchical linear regression was conducted to determine if 3-month IPV predicted 12-month depressive symptoms across trial arms (Hypothesis 1). Hierarchical linear regression was then conducted to examine if the relationship between 3-month activation and 12-month depressive symptoms was moderated by 3-month IPV within each trial arm (Hypothesis 2). As expected, participants experiencing IPV had significantly lower activation levels and higher depressive symptoms compared with participants who did not experience IPV at 3 and 12 months in cross-sectional analyses. Similarly, IPV endorsed at 3 months significantly predicted depressive symptoms at 12 months. However, activation was significantly associated with less severe depressive symptoms at 12 months, irrespective of IPV endorsement among HAP participants. For EUC participants, IPV remained the only significant predictor of depressive symptoms at 12 months. Results suggest that women experiencing IPV can still benefit from behavioral activation.",2019,"As expected, participants experiencing IPV had significantly lower activation levels and higher depressive symptoms compared with participants who did not experience IPV at 3 and 12 months in cross-sectional analyses.","['women experiencing IPV in Goa, India, can benefit from the Healthy Activity Program (HAP', 'women experiencing intimate partner violence']",['Psychological treatments'],"['severe depressive symptoms', 'depressive symptoms', 'activation and IPV', 'activation levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0694035,"As expected, participants experiencing IPV had significantly lower activation levels and higher depressive symptoms compared with participants who did not experience IPV at 3 and 12 months in cross-sectional analyses.","[{'ForeName': 'Anushka Rajesh', 'Initials': 'AR', 'LastName': 'Patel', 'Affiliation': 'Department of Psychology, The University of Tulsa, 800 S. Tucker Drive, Tulsa, OK, 74104, USA.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Weobong', 'Affiliation': 'School of Public Health, Department of Social and Behavioural Sciences, College of Health Sciences, University of Ghana, Accra, Ghana.'}, {'ForeName': 'Vikram Harshad', 'Initials': 'VH', 'LastName': 'Patel', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, 641 Huntington Avenue, Boston, MA, 02115, USA.'}, {'ForeName': 'Daisy Radha', 'Initials': 'DR', 'LastName': 'Singla', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sinai Health System, 600 University Ave, Rm914A, Toronto, Ontario, M5T 1R8, Canada. daisy.singla@utoronto.ca.'}]",Archives of women's mental health,['10.1007/s00737-019-00992-2']
3657,31669193,"Adjuvant effect of TLR7 agonist adsorbed on aluminum hydroxide (AS37): A phase I randomized, dose escalation study of an AS37-adjuvanted meningococcal C conjugated vaccine.","An adjuvant system (AS37) has been developed containing a synthetic toll-like receptor agonist (TLR7a). We conducted a phase I randomized, observer-blind, dose-escalation study to assess the safety and immunogenicity of an investigational AS37-adjuvanted meningococcus C (MenC) conjugate vaccine in healthy adults (NCT02639351). A control group received a licensed MenC conjugate alum-adjuvanted vaccine. Eighty participants were randomized to receive one dose of control or investigational vaccine containing AS37 (TLR7a dose 12.5, 25, 50, 100 μg). All vaccines were well tolerated, apart from in the TLR7a 100 μg dose group, which had three reports (18.8%) of severe systemic adverse events. Four weeks after vaccination, human complement serum bactericidal assay seroresponse rates against MenC were 56-81% in all groups, and ELISA seroresponses were ≥81% for all AS37-adjuvanted vaccine groups (100% in 50 and 100 μg dose groups) and 88% in the control group. Antibody responses were maintained at six months after vaccination.",2019,"Four weeks after vaccination, human complement serum bactericidal assay seroresponse rates against MenC were 56-81% in all groups, and ELISA seroresponses were ≥81% for all AS37-adjuvanted vaccine groups (100% in 50 and 100 μg dose groups) and 88% in the control group.","['Eighty participants', 'healthy adults (NCT02639351']","['TLR7 agonist', 'adjuvant system (AS37', 'control or investigational vaccine containing AS37 (TLR7a', 'aluminum hydroxide (AS37', 'AS37-adjuvanted meningococcal C conjugated vaccine', 'licensed MenC conjugate alum-adjuvanted vaccine', 'investigational AS37-adjuvanted meningococcus C (MenC) conjugate vaccine']","['tolerated', 'Antibody responses', 'ELISA seroresponses', 'safety and immunogenicity', 'severe systemic adverse events']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}, {'cui': 'C0915344', 'cui_str': 'serogroup C meningococcal conjugate vaccine'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0137988', 'cui_str': 'alum'}, {'cui': 'C0027575', 'cui_str': 'Neisseria meningitidis'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",80.0,0.132402,"Four weeks after vaccination, human complement serum bactericidal assay seroresponse rates against MenC were 56-81% in all groups, and ELISA seroresponses were ≥81% for all AS37-adjuvanted vaccine groups (100% in 50 and 100 μg dose groups) and 88% in the control group.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gonzalez-Lopez', 'Affiliation': 'GSK Slaoui Center for Vaccines Research, 14200 Shady Grove Rd, Rockville, MD, USA.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Oostendorp', 'Affiliation': 'GSK Slaoui Center for Vaccines Research, 14200 Shady Grove Rd, Rockville, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Koernicke', 'Affiliation': 'PAREXEL International GmbH, Spandauer Damm 130, D-14050 Berlin, Germany.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Fadini', 'Affiliation': 'PAREXEL International GmbH, Spandauer Damm 130, D-14050 Berlin, Germany.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': ""D'Oro"", 'Affiliation': 'GSK, Via Fiorentina 1, Siena, Italy.'}, {'ForeName': 'Sherryl', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'GSK Slaoui Center for Vaccines Research, 14200 Shady Grove Rd, Rockville, MD, USA.'}, {'ForeName': 'Derek T', 'Initials': 'DT', 'LastName': ""O'Hagan"", 'Affiliation': 'GSK Slaoui Center for Vaccines Research, 14200 Shady Grove Rd, Rockville, MD, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Del Giudice', 'Affiliation': 'GSK, Via Fiorentina 1, Siena, Italy.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Siena', 'Affiliation': 'GSK, Via Fiorentina 1, Siena, Italy.'}, {'ForeName': 'Oretta', 'Initials': 'O', 'LastName': 'Finco', 'Affiliation': 'GSK, Via Fiorentina 1, Siena, Italy.'}, {'ForeName': 'Duccio', 'Initials': 'D', 'LastName': 'Medini', 'Affiliation': 'GSK, Via Fiorentina 1, Siena, Italy. Electronic address: duccio.x.medini@gsk.com.'}]","Clinical immunology (Orlando, Fla.)",['10.1016/j.clim.2019.108275']
3658,31740723,Oxytocin reduces the functional connectivity between brain regions involved in eating behavior in men with overweight and obesity.,"BACKGROUND


Oxytocin (OXT), shown to decrease food intake in animal models and men, is a promising novel treatment for obesity. We have shown that in men with overweight and obesity, intranasal (IN) OXT reduced the functional magnetic resonance imaging (fMRI) blood oxygenation level-dependent signal in the ventral tegmental area (VTA), the origin of the mesolimbic dopaminergic reward system, in response to high-calorie food vs. nonfood images. Here, we employed functional connectivity fMRI analysis, which measures the synchrony in activation between neural systems in a context-dependent manner. We hypothesized that OXT would attenuate the functional connectivity of the VTA with key food motivation brain areas only when participants viewed high-calorie food stimuli.
METHODS


This randomized, double-blind, and placebo-controlled crossover study of 24 IU IN OXT included ten men with overweight or obesity (mean ± SEM BMI: 28.9 ± 0.8 kg/m 2 ). Following drug administration, subjects completed an fMRI food motivation paradigm including images of high and low-calorie foods, nonfood objects, and fixation stimuli. A psychophysiological interaction analysis was performed with the VTA as seed region.
RESULTS


Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05). There was no difference in functional connectivity between VTA and these brain areas when comparing OXT and placebo for low-calorie food, nonfood, and fixation images.
CONCLUSION


In men with overweight and obesity, OXT attenuates the functional connectivity between the VTA and food motivation brain regions in response to high-calorie visual food images. These findings could partially explain the observed anorexigenic effect of OXT, providing insight into the mechanism through which OXT ameliorates food cue-induced reward anticipation in patients with obesity. Additional studies are ongoing to further delineate the anorexigenic effect of OXT in obesity.",2020,"Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05).","['men with overweight and obesity', 'ten men with overweight or obesity (mean\u2009±\u2009SEM BMI: 28.9\u2009±\u20090.8\u2009kg/m 2 ', 'men with overweight and obesity, intranasal (IN', 'patients with obesity']","['OXT', '24 IU IN OXT', 'placebo', 'Oxytocin', 'OXT and placebo', 'Oxytocin (OXT']","['insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods', 'functional connectivity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0228262', 'cui_str': 'Operculum structure'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0453831', 'cui_str': 'High energy food (substance)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.191194,"Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05).","[{'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Kerem', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nouchine', 'Initials': 'N', 'LastName': 'Hadjikhani', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Holsen', 'Affiliation': ""Division of Women's Health, Department of Medicine and Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Lawson', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. ealawson@partners.org.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Plessow', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. fplessow@mgh.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-019-0489-7']
3659,31402718,"Longer analgesic effect with naproxen sodium than ibuprofen in post-surgical dental pain: a randomized, double-blind, placebo-controlled, single-dose trial.","Background:  Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as first-line medications in mild-to-moderate acute pain. However, comparative data regarding the duration of analgesia for commonly-used NSAIDs at non-prescription doses is lacking. This study evaluated the time to rescue medication following a single dose of naproxen sodium (NAPSO) vs ibuprofen (IBU) and placebo in subjects with moderate-to-severe post-surgical dental pain. Methods:  This single-center, randomized, double-blind, parallel group, placebo-controlled study included healthy subjects with moderate-to-severe baseline pain (Categorical Pain Intensity Scale) who also rated their pain ≥ 5 on a 0-10 pain intensity Numerical Rating Scale following extraction of two impacted mandibular third molars. A single oral dose of NAPSO (440 mg), IBU (400 mg), or placebo was administered. The primary efficacy endpoint was the time to first rescue medication, while secondary endpoints included the sum of pain intensity difference (SPID) and total pain relief (TOTPAR) over 24 h. ClinicalTrials.gov trial registration number: NCT03404206 (EudraCT 2017-005049-67). Results:  In the per protocol population ( n  = 385; mean age = 19 years), the time to rescue medication was significantly ( p  < .001) longer with NAPSO than IBU and placebo. After treatment, the greatest separation of NAPSO from IBU occurred at 9-14 h and from placebo at 1-6 h. Fewer NAPSO subjects required rescue medication (58/166, 34.9%) compared with IBU (137/165, 83.0%) and placebo (44/54, 81.5%). SPID 0-24 h and TOTPAR 0-24 h were both greater with NAPSO than IBU or placebo. Conclusions:  The duration of pain relief after a single dose of NAPSO was significantly longer than after IBU, and significantly fewer NAPSO-treated subjects required rescue medication over a 24-h period.",2019,-24 h and TOTPAR 0-24 h were both greater with NAPSO than IBU or placebo.  ,"['post-surgical dental pain', 'healthy subjects with moderate-to-severe baseline pain (Categorical Pain Intensity Scale) who also rated their pain ≥ 5 on a 0-10 pain intensity Numerical Rating Scale following extraction of two impacted mandibular third molars', 'subjects with moderate-to-severe post-surgical dental pain']","['placebo', ':  Non-steroidal anti-inflammatory drugs (NSAIDs', 'naproxen sodium (NAPSO) vs ibuprofen (IBU) and placebo', 'naproxen sodium', 'ibuprofen', 'NAPSO']","['time to rescue medication', 'greatest separation of NAPSO from IBU', 'rescue medication', 'duration of pain relief', 'time to first rescue medication', 'sum of pain intensity difference (SPID) and total pain relief (TOTPAR']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0546873', 'cui_str': 'Naproxen sodium'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0721022', 'cui_str': 'Ibu'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.729776,-24 h and TOTPAR 0-24 h were both greater with NAPSO than IBU or placebo.  ,"[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Cooper', 'Affiliation': 'Stephen A. Cooper, DMD, PhD, LLC, Palm Beach Gardens, FL, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Desjardins', 'Affiliation': 'Desjardins Associates, LLC, Maplewood, NJ, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Brain', 'Affiliation': 'Jean Brown Research, Salt Lake City, UT, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Paredes-Diaz', 'Affiliation': 'Global Medical Affairs, Bayer Consumer Health, Whippany, NJ, USA.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Troullos', 'Affiliation': 'Global Medical Affairs, Bayer Consumer Health, Whippany, NJ, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Centofanti', 'Affiliation': 'Clinical Development, Bayer Consumer Health, Whippany, NJ, USA.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'An', 'Affiliation': 'Biostatistics, Bayer Consumer Health, Whippany, NJ, USA.'}]",Current medical research and opinion,['10.1080/03007995.2019.1655257']
3660,31767591,Improvement of perioperative care of the elderly patient (PeriAge): protocol of a controlled interventional feasibility study.,"INTRODUCTION


Geriatric patients have a pronounced risk to suffer from postoperative complications. While effective risk-specific perioperative measures have been studied in controlled experimental settings, they are rarely found in routine healthcare. This study aims (1) to implement a multicomponent preoperative and intraoperative intervention, and investigate its feasibility, and (2) exploratorily assess the effectiveness of the intervention in routine healthcare.
METHODS AND ANALYSIS


Feasibility and exploratory effectiveness of the intervention will be investigated in a monocentric, prospective, non-randomised, controlled trial. The intervention includes systematic information for patients and family about measures to prevent postoperative complications; preoperative screening for frailty, malnutrition, strength and mobility with nutrient supplementation and physical exercise (prehabilitation) as needed. Further components focus on potentially inadequate medication, patient blood-management and carbohydrate loading prior to surgery, retainment of orientation aids in the operating room and a geriatric anaesthesia concept. Data will successively be collected from control, implementation and intervention groups. Patients aged 65+ with impending surgery will be included. A sample size of 240, n=80 per group, is planned. Assessments will take place at inclusion and 2, 30 and 180 days after surgery. Mixed-methods analyses will be performed. Exploratory effectiveness will be assessed using mixed segmented regressions. The primary endpoint is functional status. Secondary endpoints include cognitive performance, health-related quality of life, length of inpatient stay and occurrence of postoperative complications. Feasibility will be assessed through semi-structured interviews with staff and patients and quantitative analyses of the data quality, focussing on practicability, acceptance, adoption and fidelity to protocol.
ETHICS AND DISSEMINATION


The study will be carried out in accordance with the Helsinki Declaration and to principles of good scientific practice. The Ethics Committee of the Medical Association Hamburg, Germany, approved the protocol (study ID: PV5596). Results will be disseminated in scientific journals and healthcare conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Identifier: NCT03325413.",2019,"Secondary endpoints include cognitive performance, health-related quality of life, length of inpatient stay and occurrence of postoperative complications.","['Geriatric patients', 'Patients aged 65+ with impending surgery will be included']","['multicomponent preoperative and intraoperative intervention', 'nutrient supplementation and physical exercise (prehabilitation']","['cognitive performance, health-related quality of life, length of inpatient stay and occurrence of postoperative complications', 'functional status', 'Exploratory effectiveness']","[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0420512', 'cui_str': 'Inpatient stay (finding)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0980783,"Secondary endpoints include cognitive performance, health-related quality of life, length of inpatient stay and occurrence of postoperative complications.","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Olotu', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lebherz', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany l.lebherz@uke.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mende', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Plümer', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alwin E', 'Initials': 'AE', 'LastName': 'Goetz', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Zöllner', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Kiefmann', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-031837']
3661,30962095,A phase 1 randomized study assessing safety and immunogenicity of two 3-dose regimens of a Clostridium difficile vaccine in healthy older Japanese adults.,"BACKGROUND


Clostridium difficile infection (CDI) is a major global cause of nosocomial and community-acquired infections. Despite potentially severe or fatal complications and frequent recurrence, no preventive vaccine is currently available. This randomized, observer-blinded, placebo-controlled phase 1 study in older Japanese adults evaluated safety and immunogenicity of an investigational C difficile vaccine containing a mixture of genetically detoxified and chemically inactivated toxoids, A and B.
METHODS


Healthy Japanese adults aged 65 to 85 years were randomized in a 3:3:2 ratio to receive 100 or 200 μg of C difficile vaccine or placebo, respectively, at 0, 1, and 6 months (month regimen) or 1, 8, and 30 days (day regimen). The primary objective was safety evaluation. Vaccine immunogenicity, the secondary objective, was determined by assessing toxin A- and toxin B-specific neutralizing antibody levels in human sera.
RESULTS


Local reactions were reported by up to 33.3% of subjects per dose in the month regimen; percentages were generally higher in the 200-μg group. Such reactions were all mild or moderate in severity and generally transient. No adverse events in the month regimen led to subject withdrawal, and no serious adverse events were considered vaccine related. Further enrollment and dosing in the day regimen were discontinued after 3 subjects in the 100-μg group reported severe redness after dose 2. In the month regimen study arm, immune responses as measured by toxin-neutralizing antibody geometric mean concentrations, geometric mean fold rises, and proportions of subjects achieving prespecified fold rises were generally higher in the 200-μg group, peaked at month 7, and remained elevated at month 12.
CONCLUSIONS


The C difficile vaccine candidate was safe, well tolerated, and immunogenic when administered to healthy older Japanese adults at 0, 1, and 6 months. Results support continued development of the vaccine for the prevention of CDI. ClinicalTrials.gov identifier: NCT02725437.",2019,"No adverse events in the month regimen led to subject withdrawal, and no serious adverse events were considered vaccine related.","['Healthy Japanese adults aged 65 to 85\u202fyears', 'healthy older Japanese adults', 'older Japanese adults', 'human sera']","['C difficile vaccine or placebo', 'Clostridium difficile vaccine', 'placebo', 'investigational C difficile vaccine containing a mixture of genetically detoxified and chemically inactivated toxoids, A and B']","['adverse events', 'toxin-neutralizing antibody geometric mean concentrations, geometric mean fold rises, and proportions of subjects achieving prespecified fold rises', 'toxin A- and toxin B-specific neutralizing antibody levels', 'severe redness', 'safety and immunogenicity']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0040555', 'cui_str': 'Toxoids'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0076851', 'cui_str': 'toxin A (Pseudomonas)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.155125,"No adverse events in the month regimen led to subject withdrawal, and no serious adverse events were considered vaccine related.","[{'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'SOUSEIKAI PS Clinic, Fukuoka, Japan (former employee). Electronic address: megumi.inoue8577@gmail.com.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Yonemura', 'Affiliation': 'SOUSEIKAI Sumida Hospital, Tokyo, Japan. Electronic address: takuma-yonemura@lta-med.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'de Solom', 'Affiliation': 'Pfizer Australia, Sydney, NSW, Australia. Electronic address: richard.desolom@pfizer.com.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Yamaji', 'Affiliation': 'Pfizer R&D Japan G.K., Tokyo, Japan. Electronic address: masako.yamaji@pfizer.com.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Aizawa', 'Affiliation': 'Pfizer R&D Japan G.K., Tokyo, Japan. Electronic address: masakazu.aizawa@pfizer.com.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Knirsch', 'Affiliation': 'Pfizer Inc, Pearl River, NY, USA. Electronic address: charles.knirsch@pfizer.com.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Pride', 'Affiliation': 'Pfizer Inc, Pearl River, NY, USA. Electronic address: michael.pride@pfizer.com.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Pfizer Inc, Pearl River, NY, USA. Electronic address: kathrin.jansen@pfizer.com.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gruber', 'Affiliation': 'Pfizer Inc, Pearl River, NY, USA. Electronic address: bill.gruber@pfizer.com.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Webber', 'Affiliation': 'Pfizer Inc, Pearl River, NY, USA. Electronic address: chris.webber@pfizer.com.'}]",Vaccine,['10.1016/j.vaccine.2019.03.014']
3662,30953768,Emotional expressions of the sick face.,"To handle the substantial threat posed by infectious diseases, behaviors that promote avoidance of contagion are crucial. Based on the fact that sickness depresses mood and that emotional expressions reveal inner states of individuals to others, which in turn affect approach/avoidance behaviors, we hypothesized that facial expressions of emotion may play a role in sickness detection. Using an experimental model of sickness, 22 volunteers were intravenously injected with either endotoxin (lipopolysaccharide; 2 ng/kg body weight) and placebo using a randomized cross-over design. The volunteers were two hours later asked to keep a relaxed expression on their face while their facial photograph was taken. To assess the emotional expression of the sick face, 49 participants were recruited and were asked to rate the emotional expression of the facial photographs of the volunteers when sick and when healthy. Our results indicate that the emotional expression of faces changed two hours after being made temporarily sick by an endotoxin injection. Sick faces were perceived as more sick/less healthy, but also as expressing more negative emotions, such as sadness and disgust, and less happiness and surprise. The emotional expressions mediated 59.1% of the treatment-dependent change in rated health. The inclusion of physical features associated with emotional expressions to the mediation analysis supported these results. We conclude that emotional expressions may contribute to detection and avoidance of infectious individuals and thereby be part of a behavioral defense against disease.",2019,"Sick faces were perceived as more sick/less healthy, but also as expressing more negative emotions, such as sadness and disgust, and less happiness and surprise.",['49 participants were recruited and were asked to rate the emotional expression of the facial photographs of the volunteers when sick and when healthy'],"['endotoxin (lipopolysaccharide', 'placebo']","['Emotional expressions', 'emotional expressions']","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",49.0,0.0349709,"Sick faces were perceived as more sick/less healthy, but also as expressing more negative emotions, such as sadness and disgust, and less happiness and surprise.","[{'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Sarolidou', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. Electronic address: georgia.sarolidou@ki.se.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Axelsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stress Research Institute, Stockholm University, Stockholm, Sweden; Osher Center for Integrative Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Sundelin', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stress Research Institute, Stockholm University, Stockholm, Sweden; Department of Social Psychology, New York University, New York, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lasselin', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stress Research Institute, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Regenbogen', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Institute of Neuroscience and Medicine: JARA-Institute Brain Structure Function Relationship (INM-10), Research Center Jülich, Jülich, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Sorjonen', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Johan N', 'Initials': 'JN', 'LastName': 'Lundström', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Monell Chemical Senses Center, Philadelphia, USA; Department of Psychology, University of Pennsylvania, Philadelphia, USA; Stockholm University Brain Imaging Centre, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stress Research Institute, Stockholm University, Stockholm, Sweden; Osher Center for Integrative Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mats J', 'Initials': 'MJ', 'LastName': 'Olsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.04.003']
3663,31100611,The effects of transcranial direct current stimulation compared to standard bupropion for the treatment of tobacco dependence: A randomized sham-controlled trial.,"BACKGROUND


Current treatments for smoking cessation are not effective for most smokers. This study aims to examine the effectiveness of transcranial Direct Current Stimulation (tDCS) on smoking cessation.
METHODS


In this randomized, sham-controlled trial study, tobacco-dependent (by DSM-5) male participants were recruited from the general public invitation. Participants were randomly allocated to 5 groups; (A), treatment with 300 mg bupropion for 8 weeks; (B), active tDCS (20 sessions for 4 weeks); (C), sham for group B ; (D), active tDCS (20 sessions for 12 weeks), and (E), sham for group D. The electrode montage was anode F3 and cathode F4. Study outcomes include salivary cotinine, Fagerstrom test for nicotine dependence, and smoked cigarette per day, were examined on three time points. Repeated-measures analysis of variances and the generalized estimation equation (GEE) model were employed for data analysis.
RESULTS


Among 210 volunteers, 170 participants completed the study. Mean age of participants was 42.9 years, ranging from 21 to 64 years. The 6-month point abstinence rates in groups A, B and D were 20%, 7% and 25.7%, and in C, D sham groups were 3.1% and 3% respectively. Results of the GEE model showed that although group D was not different from group A in abstinence rate, i.e., salivary cotinine >4 (p = 0.266), nicotine dependency by Fagerstrom test was lower in this group compared to group A (p = 0.019).
CONCLUSIONS


The 12-week tDCS had a clinically good therapeutic effect on smoking cessation and its dependency. It may be a substitute for bupropion treatment.",2019,"Results of the GEE model showed that although group D was not different from group A in abstinence rate, i.e., salivary cotinine >4 (p = 0.266), nicotine dependency by Fagerstrom test was lower in this group compared to group A (p = 0.019).
","['tobacco dependence', '210 volunteers, 170 participants completed the study', 'Mean age of participants was 42.9 years, ranging from 21 to 64 years', 'tobacco-dependent (by DSM-5) male participants were recruited from the general public invitation']","['bupropion', 'active tDCS', 'transcranial direct current stimulation', 'standard bupropion', 'transcranial Direct Current Stimulation (tDCS']","['smoking cessation', '6-month point abstinence rates', 'salivary cotinine, Fagerstrom test for nicotine dependence, and smoked cigarette per day', 'nicotine dependency by Fagerstrom test']","[{'cui': 'C0040332', 'cui_str': 'Tobacco Dependence'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517773', 'cui_str': 'Forty-two point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0451156', 'cui_str': 'Fagerstrom test for nicotine dependence (assessment scale)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",210.0,0.0739456,"Results of the GEE model showed that although group D was not different from group A in abstinence rate, i.e., salivary cotinine >4 (p = 0.266), nicotine dependency by Fagerstrom test was lower in this group compared to group A (p = 0.019).
","[{'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Ghorbani Behnam', 'Affiliation': 'Student Research Committee, School of Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Seyed Abbas', 'Initials': 'SA', 'LastName': 'Mousavi', 'Affiliation': 'Center for Health Related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Mohammad Hassan', 'Initials': 'MH', 'LastName': 'Emamian', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shahroud University of Medical Sciences, Shahroud, Iran. Electronic address: emamian@shmu.ac.ir.'}]",European psychiatry : the journal of the Association of European Psychiatrists,['10.1016/j.eurpsy.2019.04.010']
3664,31173422,"Effectiveness of a large-scale handwashing promotion intervention on handwashing behaviour in Dhaka, Bangladesh.","OBJECTIVE


The behavioural effect of large-scale handwashing promotion programmes has been infrequently evaluated, and variation in the effect over time has not been described. We assess the effect of a large-scale handwashing promotion programme on handwashing outcomes in a community setting in Dhaka, Bangladesh.
METHODS


We analysed data from a cluster-randomised trial that included three arms: vaccine-and-behaviour-change intervention (VBC), vaccine-only (V) and no intervention (Control). Data collectors randomly selected different subsets of households each month during the study period and assessed: (i) temporal variation in availability of soap and water at handwashing place; (ii) the use of water and soap by participants when asked to demonstrate handwashing, and; (iii) handwashing behaviour according to structured observation. We used log-binomial regression analyses to calculate prevalence ratios (PRs) and 95% confidence intervals and compare outcomes by study arms.
RESULTS


Data collectors surveyed 9325 households over 28 months. In VBC, there was a significant positive trend on availability of water and soap from baseline to 9 months after the start of the intervention (P-for-trends <0.001), and no significant trend during months 10-28 (P-for-trend = 0.297). In the entire study period, availability of water and soap was higher in VBC (43%) than in V (23%) (PR = 1.92; CI = 1.72, 2.15) and Control (28%) (PR = 1.53; CI = 1.38, 1.69) households. There were no differences between study arms with regard to use of soap during handwashing demonstrations. Observed handwashing with soap after toilet use was higher in VBC (17%) than in V (8%) (PR = 1.47, CI = 0.58, 3.75) and Control (2%) (PR = 3.47, CI = 0.48, 23.33) groups. At other possible pathogen transmission events, the prevalence of handwashing with soap was ≤3%.
CONCLUSION


VBC households maintained soap and water for handwashing, but the prevalence of observed handwashing was low in all study arms. The results underscore the need to strengthen scalable behaviour change approaches.",2019,"In VBC, there was a significant positive trend on availability of water and soap from baseline to 9 months after the start of the intervention (P-for-trends <0.001), and no significant trend during months 10-28 (P-for-trend = 0.297).","['Data collectors randomly selected different subsets of households each month during the study period and assessed: (i) temporal variation in availability of soap and water at handwashing place; (ii) the use of water and soap by participants when asked to demonstrate handwashing, and; (iii) handwashing behaviour according to structured observation', 'a community setting in Dhaka, Bangladesh', 'Data collectors surveyed 9325 households over 28\xa0months', 'handwashing behaviour in Dhaka, Bangladesh']","['large-scale handwashing promotion intervention', 'large-scale handwashing promotion programme', 'vaccine-and-behaviour-change intervention (VBC), vaccine-only (V) and no intervention (Control']","['availability of water and soap', 'prevalence of handwashing with soap']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}]",9325.0,0.0525134,"In VBC, there was a significant positive trend on availability of water and soap from baseline to 9 months after the start of the intervention (P-for-trends <0.001), and no significant trend during months 10-28 (P-for-trend = 0.297).","[{'ForeName': 'Wit', 'Initials': 'W', 'LastName': 'Wichaidit', 'Affiliation': 'Department of Epidemiology and Environmental Health, State University of New York, Buffalo, NY, USA.'}, {'ForeName': 'Shwapon', 'Initials': 'S', 'LastName': 'Biswas', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Begum', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Yeasmin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Fosiul Alam', 'Initials': 'FA', 'LastName': 'Nizame', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Najnin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Elli', 'Initials': 'E', 'LastName': 'Leontsini', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Winch', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Unicomb', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Pavani K', 'Initials': 'PK', 'LastName': 'Ram', 'Affiliation': 'Department of Epidemiology and Environmental Health, State University of New York, Buffalo, NY, USA.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13277']
3665,31182338,Sitagliptin improves diastolic cardiac function but not cardiorespiratory fitness in adults with type 2 diabetes.,"BACKGROUND


People with type 2 diabetes mellitus (T2D) have preclinical cardiac and vascular dysfunction associated with low cardiorespiratory fitness (CRF). This is especially concerning because CRF is a powerful predictor of cardiovascular mortality, a primary issue in T2D management. Glucagon-like pepetide-1 (GLP-1) augments cardiovascular function and our previous data in rodents demonstrate that potentiating the GLP-1 signal with a dipeptidyl peptidase-4 (DPP4) inhibitor augments CRF. Lacking are pharmacological treatments which can target T2D-specific physiological barriers to exercise to potentially permit adaptations necessary to improve CRF and thereby health outcomes in people with T2D. We therefore hypothesized that administration of a DPP4-inhibitor (sitagliptin) would improve CRF in adults with T2D.
METHODS AND RESULTS


Thirty-eight participants (64 ± 1 years; mean ± SE) with T2D were randomized in a double-blinded study to receive 100 mg/day sitagliptin, 2 mg/day glimepiride, or placebo for 3 months after baseline measurements. Fasting glucose decreased with both glimepiride and sitagliptin compared with placebo (P = 0.002). CRF did not change in any group (Placebo: Pre: 15.4 ± 0.9 vs. Post: 16.1 ± 1.1 ml/kg/min vs. Glimepiride: 18.5 ± 1.0 vs. 17.7 ± 1.2 ml/kg/min vs. Sitagliptin: 19.1 ± 1.2 vs. 18.3 ± 1.1 ml/kg/min; P = 0.3). Sitagliptin improved measures of cardiac diastolic function, however, measures of vascular function did not change with any treatment.
CONCLUSIONS


Three months of sitagliptin improved diastolic cardiac function, however, CRF did not change. These data suggest that targeting the physiological contributors to CRF with sitagliptin alone is not an adequate strategy to improve CRF in people with T2D.
CLINICAL TRIALS REGISTRATION


www.clinicaltrials.gov NCT01951339.",2019,"Sitagliptin improved measures of cardiac diastolic function, however, measures of vascular function did not change with any treatment.
","['Thirty-eight participants (64\u202f±\u202f1\u202fyears; mean\u202f±\u202fSE) with T2D', 'adults with type 2 diabetes', 'People with type 2 diabetes mellitus (T2D', 'people with T2D']","['Glimepiride', 'placebo', 'glimepiride', 'Sitagliptin', 'DPP4-inhibitor (sitagliptin', 'Glucagon-like pepetide-1', '100\u202fmg/day sitagliptin, 2\u202fmg/day glimepiride, or placebo']","['diastolic cardiac function', 'CRF', 'cardiac diastolic function', 'vascular function', 'Fasting glucose']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",,0.204482,"Sitagliptin improved measures of cardiac diastolic function, however, measures of vascular function did not change with any treatment.
","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Scalzo', 'Affiliation': ""Division of Endocrinology, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America; Rocky Mountain Regional Veterans Administration Medical Center, United States of America. Electronic address: rebecca.scalzo@ucdenver.edu.""}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Rafferty', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, United States of America.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schauer', 'Affiliation': ""Division of Endocrinology, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America; Rocky Mountain Regional Veterans Administration Medical Center, United States of America.""}, {'ForeName': 'Amy G', 'Initials': 'AG', 'LastName': 'Huebschmann', 'Affiliation': ""Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cree-Green', 'Affiliation': ""Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America; Division of Pediatric Endocrinology, University of Colorado School of Medicine, United States of America.""}, {'ForeName': 'Jane E B', 'Initials': 'JEB', 'LastName': 'Reusch', 'Affiliation': ""Division of Endocrinology, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America; Rocky Mountain Regional Veterans Administration Medical Center, United States of America.""}, {'ForeName': 'Judith G', 'Initials': 'JG', 'LastName': 'Regensteiner', 'Affiliation': ""Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America.""}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.05.002']
3666,31588974,Endotracheal suctioning for prevention of meconium aspiration syndrome: a randomized controlled trial.,"The current version of Neonatal Resuscitation Program no longer favors routine endotracheal suctioning (ETS) in non-vigorous newborns with meconium-stained amniotic fluid (MSAF) due to possibility of procedure-related harms and questionable benefits. However, it calls for additional research on this procedure to provide a definitive answer. The present study was conducted to evaluate the role of ETS in non-vigorous neonates of ≥ 34 weeks' gestation born through MSAF on the incidence of meconium aspiration syndrome (MAS). In this open-label randomized controlled trial, 132 non-vigorous neonates with MSAF were randomized to receive ETS (n = 66) or no-ETS (n = 66) during delivery room resuscitation (DRR). Primary outcome variable was incidence of MAS. Secondary outcome variables were requirement of DRR, need of respiratory support, development of complications, duration of hospitalization, and mortality. Both the groups were comparable with respect to maternal and neonatal characteristics. Incidence of MAS was 21 (31.8%) and 15 (22.7%) cases in ETS and no-ETS groups, respectively (relative risk (RR), 1.400, 95% confidence interval (CI), 0.793-2.470). The two groups did not differ with regard to DRR, need for respiratory support, and development of complications. Nine (13.6%) neonates in ETS group, and 5 (7.5%) in no-ETS group died (p > 0.05). Median (interquartile range) duration of hospital stay was 54 (31-141) h and 44 (26-102) h in ETS and no-ETS groups, respectively (p > 0.05).Conclusions: Routine ETS at birth is not useful in preventing MAS in non-vigorous neonates of ≥ 34 weeks' gestation born through MSAF.Trial registration: Clinical Trials Registry of India (CTRI/2015/04/008819).What is Known:• Routine endotracheal suctioning is of questionable benefit in non-vigorous newborns with meconium stained amniotic fluid and may have a possibility of procedure-related harms.What is New:• Routine endotracheal suctioning at birth is not useful in preventing meconium aspiration syndrome in non-vigorous newborns of ≥ 34 weeks' gestation born through meconium stained amniotic fluid.",2019,Routine endotracheal suctioning at birth is not useful in preventing meconium aspiration syndrome in non-vigorous newborns of ≥ 34 weeks' gestation born through meconium stained amniotic fluid.,"['non-vigorous neonates of ≥', ""34\xa0weeks' gestation born through MSAF.Trial registration"", 'meconium aspiration syndrome', 'non-vigorous newborns with meconium-stained amniotic fluid (MSAF', ""non-vigorous newborns of ≥ 34 weeks' gestation born through meconium stained amniotic fluid"", '132 non-vigorous neonates with MSAF']","['Neonatal Resuscitation Program no longer favors routine endotracheal suctioning (ETS', 'Routine endotracheal suctioning', 'Endotracheal suctioning', 'MSAF', 'ETS (n\u2009=\u200966) or no-ETS (n\u2009=\u200966) during delivery room resuscitation (DRR', 'ETS']","['meconium aspiration syndrome (MAS', 'meconium aspiration syndrome', 'requirement of DRR, need of respiratory support, development of complications, duration of hospitalization, and mortality', 'Incidence of MAS', 'DRR, need for respiratory support, and development of complications', 'incidence of MAS', 'Median (interquartile range) duration of hospital stay']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0025048', 'cui_str': 'Meconium Aspiration Syndrome'}, {'cui': 'C0426209', 'cui_str': 'Amniotic fluid -meconium stain (finding)'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0011212', 'cui_str': 'Centers, Hospital Birth'}]","[{'cui': 'C0025048', 'cui_str': 'Meconium Aspiration Syndrome'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.19261,Routine endotracheal suctioning at birth is not useful in preventing meconium aspiration syndrome in non-vigorous newborns of ≥ 34 weeks' gestation born through meconium stained amniotic fluid.,"[{'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India. ashokkumar_bhu@hotmail.com.'}, {'ForeName': 'Preetam', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India.'}, {'ForeName': 'Sriparna', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Neonatology, All India Institute of Medical Sciences, Rishikesh, India.'}]",European journal of pediatrics,['10.1007/s00431-019-03463-z']
3667,31772347,Differences in high-definition transcranial direct current stimulation over the motor hotspot versus the premotor cortex on motor network excitability.,"The effectiveness of transcranial direct current stimulation (tDCS) placed over the motor hotspot (thought to represent the primary motor cortex (M1)) to modulate motor network excitability is highly variable. The premotor cortex-particularly the dorsal premotor cortex (PMd)-may be a promising alternative target to reliably modulate motor excitability, as it influences motor control across multiple pathways, one independent of M1 and one with direct connections to M1. This double-blind, placebo-controlled preliminary study aimed to differentially excite motor and premotor regions using high-definition tDCS (HD-tDCS) with concurrent functional magnetic resonance imaging (fMRI). HD-tDCS applied over either the motor hotspot or the premotor cortex demonstrated high inter-individual variability in changes on cortical motor excitability. However, HD-tDCS over the premotor cortex led to a higher number of responders and greater changes in local fMRI-based complexity than HD-tDCS over the motor hotspot. Furthermore, an analysis of individual motor hotspot anatomical locations revealed that, in more than half of the participants, the motor hotspot is not located over anatomical M1 boundaries, despite using a canonical definition of the motor hotspot. This heterogeneity in stimulation site may contribute to the variability of tDCS results. Altogether, these preliminary findings provide new considerations to enhance tDCS reliability.",2019,HD-tDCS applied over either the motor hotspot or the premotor cortex demonstrated high inter-individual variability in changes on cortical motor excitability.,[],"['transcranial direct current stimulation (tDCS', 'placebo', 'HD-tDCS', 'high-definition tDCS (HD-tDCS) with concurrent functional magnetic resonance imaging (fMRI']",[],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]",[],,0.0726255,HD-tDCS applied over either the motor hotspot or the premotor cortex demonstrated high inter-individual variability in changes on cortical motor excitability.,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lefebvre', 'Affiliation': 'Neural Plasticity and Neurorehabilitation Laboratory, Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Jann', 'Affiliation': 'Laboratory of FMRI Technology (LOFT), USC Stevens Neuroimaging and Informatics Institute, Keck School of Medicine of USC, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Schmiesing', 'Affiliation': 'Neural Plasticity and Neurorehabilitation Laboratory, Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Neural Plasticity and Neurorehabilitation Laboratory, Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Jog', 'Affiliation': 'Laboratory of FMRI Technology (LOFT), USC Stevens Neuroimaging and Informatics Institute, Keck School of Medicine of USC, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Schweighofer', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Danny J J', 'Initials': 'DJJ', 'LastName': 'Wang', 'Affiliation': 'Laboratory of FMRI Technology (LOFT), USC Stevens Neuroimaging and Informatics Institute, Keck School of Medicine of USC, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Sook-Lei', 'Initials': 'SL', 'LastName': 'Liew', 'Affiliation': 'Neural Plasticity and Neurorehabilitation Laboratory, Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, United States. sliew@chan.usc.edu.'}]",Scientific reports,['10.1038/s41598-019-53985-7']
3668,31774713,Cluster Randomized Trial to Facilitate Breast Cancer Early Diagnosis in a Rural District of Rwanda.,"PURPOSE


Feasible and effective strategies are needed to facilitate earlier diagnosis of breast cancer in low-income countries. The goal of this study was to examine the impact of health worker breast health training on health care utilization, patient diagnoses, and cancer stage in a rural Rwandan district.
METHODS


We conducted a cluster randomized trial of a training intervention at 12 of the 19 health centers (HCs) in Burera District, Rwanda, in 2 phases. We evaluated the trainings' impact on the volume of patient visits for breast concerns using difference-in-difference models. We used generalized estimating equations to evaluate incidence of HC and hospital visits for breast concerns, biopsies, benign breast diagnoses, breast cancer, and early-stage disease in catchment areas served by intervention versus control HCs.
RESULTS


From April 2015 to April 2017, 1,484 patients visited intervention HCs, and 308 visited control HCs for breast concerns. The intervention led to an increase of 4.7 visits/month for phase 1 HCs ( P  = .001) and 7.9 visits/month for phase 2 HCs ( P  = .007) compared with control HCs. The population served by intervention HCs had more hospital visits (115.1  v  20.5/100,000 person-years,  P  < .001) and biopsies (36.6  v  8.9/100,000 person-years,  P  < .001) and higher breast cancer incidence (6.9  v  3.3/100,000 person-years;  P  = .28). The incidence of early-stage breast cancer was 3.3 per 100,000 in intervention areas and 0.7 per 100,000 in control areas ( P  = .048).
CONCLUSION


In this cluster randomized trial in rural Rwanda, the training of health workers and establishment of regular breast clinics were associated with increased numbers of patients who presented with breast concerns at health facilities, more breast biopsies, and a higher incidence of benign breast diagnoses and early-stage breast cancers.",2019,The intervention led to an increase of 4.7 visits/month for phase 1 HCs ( P  = .001) and 7.9 visits/month for phase 2 HCs ( P  = .007) compared with control HCs.,"['health care utilization, patient diagnoses, and cancer stage in a rural Rwandan district', 'at 12 of the 19 health centers (HCs) in Burera District, Rwanda, in 2 phases', 'Early Diagnosis in a Rural District of Rwanda', '1,484 patients visited intervention HCs, and 308 visited control HCs for breast concerns', 'patients who presented with breast concerns at health facilities, more breast biopsies, and a higher incidence of benign breast diagnoses and early-stage breast cancers', 'From April 2015 to April 2017']","['health worker breast health training', 'training intervention']","['breast cancer incidence', 'incidence of early-stage breast cancer', 'hospital visits']","[{'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0035978', 'cui_str': 'Ruanda'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0405352', 'cui_str': 'Biopsy of breast (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",1484.0,0.0429565,The intervention led to an increase of 4.7 visits/month for phase 1 HCs ( P  = .001) and 7.9 visits/month for phase 2 HCs ( P  = .007) compared with control HCs.,"[{'ForeName': 'Lydia E', 'Initials': 'LE', 'LastName': 'Pace', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Jean Marie Vianney', 'Initials': 'JMV', 'LastName': 'Dusengimana', 'Affiliation': 'Partners in Health, Kigali, Rwanda.'}, {'ForeName': 'Lawrence N', 'Initials': 'LN', 'LastName': 'Shulman', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Schleimer', 'Affiliation': 'Harvard Medical School, Boston, MA.'}, {'ForeName': 'Cyprien', 'Initials': 'C', 'LastName': 'Shyirambere', 'Affiliation': 'Partners in Health, Kigali, Rwanda.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rusangwa', 'Affiliation': 'Partners in Health, Kigali, Rwanda.'}, {'ForeName': 'Gaspard', 'Initials': 'G', 'LastName': 'Muvugabigwi', 'Affiliation': 'Ministry of Health, Kigali, Rwanda.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Park', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'ChuanChin', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Jean Bosco', 'Initials': 'JB', 'LastName': 'Bigirimana', 'Affiliation': 'Partners in Health, Kigali, Rwanda.'}, {'ForeName': 'Vedaste', 'Initials': 'V', 'LastName': 'Hategekimana', 'Affiliation': 'Rwanda Biomedical Centre, Kigali, Rwanda.'}, {'ForeName': 'Vestine', 'Initials': 'V', 'LastName': 'Rugema', 'Affiliation': 'Ministry of Health, Kigali, Rwanda.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Umwizerwa', 'Affiliation': 'Ministry of Health, Kigali, Rwanda.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Keating', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Tharcisse', 'Initials': 'T', 'LastName': 'Mpunga', 'Affiliation': 'Ministry of Health, Kigali, Rwanda.'}]",Journal of global oncology,['10.1200/JGO.19.00209']
3669,31211392,Morning (Fasting) vs Afternoon Resistance Exercise in Individuals With Type 1 Diabetes: A Randomized Crossover Study.,"OBJECTIVE


To determine the effect of morning exercise in the fasting condition vs afternoon exercise on blood glucose responses to resistance exercise (RE).
RESEARCH DESIGN AND METHODS


For this randomized crossover design, 12 participants with type 1 diabetes mellitus [nine females; aged 31 ± 8.9 years; diabetes duration, 19.1 ± 8.3 years; HbA1c, 7.4% ± 0.8% (57.4 ± 8.5 mmol/mol)] performed ∼40 minutes of RE (three sets of eight repetitions, seven exercises, at the individual's predetermined eight repetition maximum) at either 7 am (fasting) or 5 pm. Sessions were performed at least 48 hours apart. Venous blood samples were collected immediately preexercise, immediately postexercise, and 60 minutes postexercise. Interstitial glucose was monitored overnight postexercise by continuous glucose monitoring (CGM).
RESULTS


Data are presented as mean ± SD. Blood glucose rose during fasting morning exercise (9.5 ± 3.0 to 10.4 ± 3.0 mmol/L), whereas it declined with afternoon exercise (8.2 ± 2.5 to 7.4 ± 2.6 mmol/L; P = 0.031 for time-by-treatment interaction). Sixty minutes postexercise, blood glucose concentration was significantly higher after fasting morning exercise than after afternoon exercise (10.9 ± 3.2 vs 7.9 ± 2.9 mmol/L; P = 0.019). CGM data indicated more glucose variability (2.7 ± 1.1 vs 2.0 ± 0.7 mmol/L; P = 0.019) and more frequent hyperglycemia (12 events vs five events; P = 0.025) after morning RE than after afternoon RE.
CONCLUSIONS


Compared with afternoon RE, morning (fasting) RE was associated with distinctly different blood glucose responses and postexercise profiles.",2019,"Sixty minutes post-exercise, blood glucose concentration was significantly higher after fasting morning exercise compared to afternoon exercise (10.9 ± 3.2 vs. 7.9 ± 2.9; p=0.019).","['Individuals with Type 1 Diabetes', '12 participants with type 1 diabetes [9 females, aged 31 ± 8.9 years, diabetes duration 19.1 ± 8.3 years, HbA1c = 7.4 ± 0.8% (57.4 ± 8.5 mmol/mol']","['morning exercise', 'Interstitial glucose was monitored overnight post-exercise by continuous glucose monitoring (CGM', 'Afternoon Resistance Exercise', 'afternoon exercise']","['frequent hyperglycemia', 'Blood glucose', 'blood glucose responses', 'blood glucose concentration', 'glucose variability', 'Venous blood samples', 'hypoglycemic events']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}]","[{'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",12.0,0.027726,"Sixty minutes post-exercise, blood glucose concentration was significantly higher after fasting morning exercise compared to afternoon exercise (10.9 ± 3.2 vs. 7.9 ± 2.9; p=0.019).","[{'ForeName': 'Saeed Reza', 'Initials': 'SR', 'LastName': 'Toghi-Eshghi', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Yardley', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, Alberta, Canada.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-02384']
3670,31122860,Immunogenicity and safety of a new live attenuated herpes zoster vaccine (NBP608) compared to Zostavax® in healthy adults aged 50 years and older.,"A multi-centre, randomised, double-blinded, active-controlled, parallel-group clinical trial was carried out to assess the immunogenicity and safety of NBP608-a newly developed live-attenuated zoster vaccine in Korea-relative to Zostavax® in healthy adults aged 50 years or older. Immune responses to the vaccine were evaluated by glycoprotein enzyme-linked immunosorbent assay (gpELISA) and enzyme-linked immunosorbent spot (ELISPOT) assays using the interferon (IFN)-γ and interleukin (IL)-2 FluoroSpot kit 6 weeks after vaccination. Safety was monitored for 26 weeks based on subjects' diaries, spontaneous reports from subjects, and history taking by the investigators. A total of 845 subjects participated in the screening, and 823 received the vaccination (413 in the NBP608 group and 411 in the comparator group). The gpELISA-determined geometric mean fold rise from baseline to post NBP608 vaccination was 2.75 [95% confidence interval, CI (2.57, 2.94)]. The gpELISA-determined adjusted geometric mean titers (GMTs) of NBP608 and the comparator were 1346.37 [95% CI (1273.99, 1422.87)] and 1674.94 [95% CI (1585.35, 1769.58)], respectively. The adjusted GMT ratio of NBP608 to the comparator was 0.80 [95% CI (0.75, 0.87)]. There was no statistically significant difference between two groups in terms of the geometric mean spot numbers determined by IFN-γ and IL-2 ELISPOT assays at 6 weeks post vaccination (P = 0.7232, 0.3844). The incidence of adverse events (AEs) within 6 weeks post vaccination was 49.82% overall (410/823, 941 cases), 50.73% (209/412, 474 cases) in the NBP608 group, and 48.91% (201/411, 467 cases) in the comparator group. The difference in AE rate between the two groups was not statistically significant (P = 0.6010). Most AEs were mild, with a rate of 83.12% in the NBP608 group and 75.37% in the comparator group. Thus, NBP608 is non-inferior to Zostavax® in terms of inducing the immune response and can be safely administered to adults aged 50 years or older. ClinicalTrials.gov Identifier: NCT03120364.",2019,"The incidence of adverse events (AEs) within 6 weeks post vaccination was 49.82% overall (410/823, 941 cases), 50.73% (209/412, 474 cases) in the NBP608 group, and 48.91% (201/411, 467 cases) in the comparator group.","['845 subjects participated in the screening, and 823 received the vaccination (413 in the NBP608 group and 411 in the comparator group', 'healthy adults aged 50 years and older', 'healthy adults aged 50\u202fyears or older', 'adults aged 50\u202fyears or older']","['interferon (IFN)-γ and interleukin (IL)-2 FluoroSpot', 'Zostavax®', 'NBP608-a newly developed live-attenuated zoster vaccine', 'new live attenuated herpes zoster vaccine (NBP608']","['geometric mean spot numbers determined by IFN-γ and IL-2 ELISPOT assays', 'AE rate', 'glycoprotein enzyme-linked immunosorbent assay (gpELISA) and enzyme-linked immunosorbent spot (ELISPOT) assays', 'incidence of adverse events (AEs', 'adjusted GMT ratio of NBP608', 'immunogenicity and safety', 'Immunogenicity and safety', 'Safety']","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C1720919', 'cui_str': 'Zostavax'}, {'cui': 'C1720918', 'cui_str': 'Zoster Vaccine'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0920508', 'cui_str': 'ELISPOT'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",845.0,0.380719,"The incidence of adverse events (AEs) within 6 weeks post vaccination was 49.82% overall (410/823, 941 cases), 50.73% (209/412, 474 cases) in the NBP608 group, and 48.91% (201/411, 467 cases) in the comparator group.","[{'ForeName': 'Won Suk', 'Initials': 'WS', 'LastName': 'Choi', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Hyun', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': ""Division of Infectious Diseases, Department of Internal Medicine, The Catholic University of Korea, Incheon St. Mary's Hospital, Incheon, Republic of Korea.""}, {'ForeName': 'Dong Sik', 'Initials': 'DS', 'LastName': 'Jung', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Hee Jung', 'Initials': 'HJ', 'LastName': 'Choi', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Yeon-Sook', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Chungnam National University School of Medicine, Daejon, Republic of Korea.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Hee-Chang', 'Initials': 'HC', 'LastName': 'Jang', 'Affiliation': 'Department of Infectious Diseases, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Eui-Cheol', 'Initials': 'EC', 'LastName': 'Shin', 'Affiliation': 'Laboratory of Immunology and Infectious Diseases, Graduate School of Medical Science & Engineering, KAIST, Daejeon, Republic of Korea.'}, {'ForeName': 'Jun-Sik', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Laboratory of Immunology and Infectious Diseases, Graduate School of Medical Science & Engineering, KAIST, Daejeon, Republic of Korea.'}, {'ForeName': 'Hun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Life Science Research Institute, SK Bioscience, Seongnam, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Hee Jin', 'Initials': 'HJ', 'LastName': 'Cheong', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea. Electronic address: heejinmd@korea.ac.kr.'}]",Vaccine,['10.1016/j.vaccine.2019.04.046']
3671,31784559,Presynaptic dopamine function measured with [ 18 F]fluorodopa and L-DOPA effects on impulsive choice.,"We previously reported that L-DOPA effects on reward-based decision-making in a randomized, placebo-controlled, double-blind, crossover study were consistent with an inverted U-shaped function whereby both low and high extremes of dopamine signaling are associated with high-impulsive choice. To test this hypothesis, we performed [ 18 F]DOPA positron emission tomography in 60 of the 87 participants in that study, and measured the effective distribution volume ratio (EDVR) of [ 18 F]DOPA influx rate to [ 18 F]dopamine washout rate, an index of presynaptic dopaminergic function. Participants with higher baseline EDVR self-reported lower impulsivity, and discounted rewards as a function of delay more strongly after receiving L-DOPA, whereas the opposite was detected for those with lower baseline EDVR. Our findings support a relationship of striatal dopaminergic activity to trait impulsivity, and the view that there is a non-linear, possibly inverted U-shaped relationship of striatal dopaminergic function with delay discounting. Individuals with optimal dopamine signaling would become more impulsive when receiving dopamine-enhancing drugs, whereas those with suboptimal dopaminergic signaling would benefit and exhibit less impulsive choice. Consideration of differences in endogenous dopamine signaling and possibly also other neurotransmitter activity may be crucial to advance understanding of the neurobiochemical mechanisms of impulsive decision-making and related mental disorders.",2019,"Participants with higher baseline EDVR self-reported lower impulsivity, and discounted rewards as a function of delay more strongly after receiving L-DOPA, whereas the opposite was detected for those with lower baseline EDVR.",['in 60 of the 87 participants in that study'],"['placebo', 'F]DOPA positron emission tomography']","['effective distribution volume ratio (EDVR) of [ 18 F]DOPA influx rate to [ 18 F]dopamine washout rate, an index of presynaptic dopaminergic function']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'function'}]",87.0,0.115468,"Participants with higher baseline EDVR self-reported lower impulsivity, and discounted rewards as a function of delay more strongly after receiving L-DOPA, whereas the opposite was detected for those with lower baseline EDVR.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Petzold', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Shakoor', 'Initials': 'S', 'LastName': 'Pooseh', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Liane', 'Initials': 'L', 'LastName': 'Oehme', 'Affiliation': 'Department of Nuclear Medicine, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Beuthien-Baumann', 'Affiliation': 'Department of Nuclear Medicine, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Edythe D', 'Initials': 'ED', 'LastName': 'London', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Department of Molecular and Medical Pharmacology and the Brain Research Institute, University of California at Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Goschke', 'Affiliation': 'Department of Psychology and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Smolka', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany. michael.smolka@tu-dresden.de.'}]",Scientific reports,['10.1038/s41598-019-54329-1']
3672,31122856,"Effectiveness of the 10-valent pneumococcal conjugate vaccine among girls, boys, preterm and low-birth-weight infants - Results from a randomized, double-blind vaccine trial.","BACKGROUND


Several studies have shown differences in susceptibility to infections and immune response to vaccines by sex. Prematurely born infants are at higher risk for pneumococcal diseases, with lower effectiveness for some vaccines compared to term infants. We have reported the effectiveness of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) on several endpoints in the Finnish Invasive Pneumococcal disease (FinIP) vaccine trial. Now, we present the results of a post-hoc analysis evaluating PHiD-CV10 effectiveness in subgroups by sex, gestational age, and birth weight.
METHODS


The FinIP trial was a phase III/IV cluster-randomized, double-blind trial. Infants enrolled < 7 months of age received PHiD-CV10 in two thirds of clusters (3 + 1 or 2 + 1 schedule) and hepatitis B vaccine as control in remaining third. Outcome data included invasive pneumococcal disease, pneumonia, tympanostomy tube placements, and antimicrobial purchases collected through national, routinely used health registers. Negative binomial model was used in the incidence and vaccine effectiveness estimation, and differences in incidences between subgroups were tested among control children.
RESULTS


Of the 30,527 infants enrolled 51% were boys. The incidences of hospital-diagnosed pneumonia and otitis-related outcomes were higher among boys in control groups. There were no significant sex differences in the vaccine effectiveness estimates. Altogether, 1519 (5%) infants were born before 37th gestational week. The incidences of pneumonia outcomes were higher among premature infants when compared to term infants. The vaccine effectiveness estimates among preterm infants were not statistically significant except for antimicrobial purchases, but all point estimates were at the same level among preterm infants as among term infants. There was no significant difference between 2 + 1 and 3 + 1 schedules in any of the subgroups analysed.
CONCLUSION


PHiD-CV10 had a similar effectiveness in both sexes, and seemed to be protective in preterm infants.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00861380 and NCT00839254.",2019,The incidences of hospital-diagnosed pneumonia and otitis-related outcomes were higher among boys in control groups.,"['girls, boys, preterm and low-birth-weight infants ', '30,527 infants enrolled 51% were boys', 'Infants enrolled\u202f<\u202f7\u202fmonths of age received', 'Finnish Invasive Pneumococcal disease (FinIP) vaccine trial', 'preterm infants']","['hepatitis B vaccine', '10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10', '10-valent pneumococcal conjugate vaccine', 'PHiD-CV10']","['incidences of hospital-diagnosed pneumonia and otitis-related outcomes', 'invasive pneumococcal disease, pneumonia, tympanostomy tube placements, and antimicrobial purchases collected through national, routinely used health registers', 'incidences of pneumonia outcomes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0021288', 'cui_str': 'Low Birth Weight Infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1320214', 'cui_str': 'Invasive Streptococcus pneumoniae disease'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0138826', 'cui_str': 'surface-exposed lipoprotein D, Haemophilus influenzae'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0450819', 'cui_str': 'CV10 (body structure)'}, {'cui': 'C3849486', 'cui_str': 'ten-valent PCV'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0029877', 'cui_str': 'Ear Inflammation'}, {'cui': 'C1320214', 'cui_str': 'Invasive Streptococcus pneumoniae disease'}, {'cui': 'C0850121', 'cui_str': 'Ventilation tube'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]",51.0,0.561733,The incidences of hospital-diagnosed pneumonia and otitis-related outcomes were higher among boys in control groups.,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nieminen', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, FinnMedi I, Biokatu 6, FI-33520 Tampere, Finland. Electronic address: heta.nieminen@thl.fi.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rinta-Kokko', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, P.O. Box 30, FI-00271 Helsinki, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jokinen', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, P.O. Box 30, FI-00271 Helsinki, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Puumalainen', 'Affiliation': 'Department of Health Security, National Institute for Health and Welfare, P.O. Box 30, FI-00271 Helsinki, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moreira', 'Affiliation': 'GSK, Avenue Fleming 20, B-1300 Wavre, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Borys', 'Affiliation': 'GSK, Avenue Fleming 20, B-1300 Wavre, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Schuerman', 'Affiliation': 'GSK, Avenue Fleming 20, B-1300 Wavre, Belgium.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Palmu', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, FinnMedi I, Biokatu 6, FI-33520 Tampere, Finland.'}]",Vaccine,['10.1016/j.vaccine.2019.05.033']
3673,31250099,Gut microbiota is associated with adiposity markers and probiotics may impact specific genera.,"PURPOSE


It has been suggested that restoring gut microbiota alterations with probiotics represents a potential clinical target for the treatment of gut microbiota-related diseases, such as obesity. Here, we apply 16S rDNA microbiota profiling to establish which bacteria in the human gut are associated with obesity and cardiometabolic risk factors, and to evaluate whether probiotic supplementation modulates gut microbiota.
METHODS


We evaluated the effects of a probiotic mixture (2 × 10 10  CFU/day of Lactobacillus acidophilus LA-14, Lactobacillus casei LC-11, Lactococcus lactis LL-23, Bifidobacterium bifidum BB-06, and Bifidobacterium lactis BL-4) in 32 overweight or obese women in a double-blind, randomized, placebo-controlled study. Using 16S rDNA sequencing, we characterized fecal samples and investigated the relationships between microbiome data and diet, body composition, antioxidant enzymes, and inflammatory profile. In addition, we characterized the degree of variation among fecal communities after the intervention.
RESULTS


BMI, weight, fat mass, lean mass, conicity index, protein intake, monounsaturated fat intake, glycated hemoglobin, TNF-α, and IL6/IL10 were significantly correlated with microbiome composition. The candidate division TM7 was strongly associated with all adiposity markers and Clostridiaceae associated negatively with TNF-α. The family Clostridiaceae increased and TM7 tended to decrease after the probiotic mixture supplementation. Subjects were clustered according to body composition, and a higher proportion of TM7 was observed in those with higher adiposity.
CONCLUSIONS


Ecosystem-wide analysis of probiotic use effects on the gut microbiota revealed a genera specific influence, and one of which (TM7) represents a promising novel target for obesity treatment.
TRIAL REGISTRATION NUMBER


U1111-1137-4566.",2020,The candidate division TM7 was strongly associated with all adiposity markers and Clostridiaceae associated negatively with TNF-α.,['32 overweight or obese women'],"['TNF-α', 'probiotic mixture', 'Lactobacillus acidophilus LA-14, Lactobacillus casei LC-11, Lactococcus lactis LL-23, Bifidobacterium bifidum BB-06, and Bifidobacterium lactis BL-4', 'placebo']","['TM7', 'BMI, weight, fat mass, lean mass, conicity index, protein intake, monounsaturated fat intake, glycated hemoglobin, TNF-α, and IL6/IL10']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0038408', 'cui_str': 'Streptococcus lactis'}, {'cui': 'C0042950', 'cui_str': 'Will'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis subsp. lactis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0556121', 'cui_str': 'Monounsaturated fat intake (observable entity)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.0853835,The candidate division TM7 was strongly associated with all adiposity markers and Clostridiaceae associated negatively with TNF-α.,"[{'ForeName': 'Aline Corado', 'Initials': 'AC', 'LastName': 'Gomes', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goias, St. 227, Block 68, Setor Leste Universitário, Goiânia, GO, 74.605-080, Brazil.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Food Sciences and Experimental Nutrition, School of Pharmaceutical Sciences, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'João Felipe', 'Initials': 'JF', 'LastName': 'Mota', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goias, St. 227, Block 68, Setor Leste Universitário, Goiânia, GO, 74.605-080, Brazil. jfemota@gmail.com.'}]",European journal of nutrition,['10.1007/s00394-019-02034-0']
3674,30249443,Glucose and lipid-related biomarkers and the antidepressant response to infliximab in patients with treatment-resistant depression.,"The tumor necrosis factor (TNF) antagonist infliximab was previously found to reduce depressive symptoms in patients with treatment-resistant major depression (TRD) who exhibited high baseline inflammation, as reflected by plasma C-reactive protein (CRP) >5 mg/L. Further predictors of antidepressant response to infliximab included differential expression of peripheral blood gene transcripts that were related not only to inflammation but also to glucose and lipid metabolism. To determine whether plasma biomarkers of glucose and lipid metabolism were similarly associated with antidepressant response to infliximab and with relevant gene transcripts, we measured concentrations of glucose, insulin, and protein hormones that regulate glucose homeostasis and metabolism (leptin, resistin, and adiponectin), as well as cholesterols, triglycerides, and non-esterified fatty acids (NEFA), in medically-stable TRD outpatients at baseline and 2 weeks after the first infusion of infliximab (n = 26) or placebo (n = 26). Treatment response was defined as 50% reduction in depressive symptoms at any point during the 12-week trial. We found that baseline cholesterol (total, low-density lipoprotein [LDL], and non-high-density lipoprotein [non-HDL]), triglycerides and NEFA were elevated in patients who exhibited an antidepressant response to infliximab (all p < 0.05) but not placebo (all p > 0.299). HDL and non-HDL cholesterol concentrations also correlated with two lipid-related gene transcripts that were predictive of antidepressant response (r = 0.33 to 0.39, p < 0.05). Although not associated with response to infliximab, resistin correlated with numerous glucose-related transcripts (r = -0.32 to 0.37, p < 0.05) and was higher at 2 weeks post-infusion in patients treated with infliximab compared to placebo (p = 0.028). Concentrations of cholesterol (total, LDL, HDL, non-HDL) were also lower at 2 weeks in patients treated with infliximab compared to placebo, but only in those patients with CRP >5 mg/L at baseline (all p < 0.05). These results are consistent with previous work showing that high inflammation in patients with depression is associated with metabolic alterations, which together predict response to both traditional and experimental antidepressant therapies. Additionally, our findings suggest a causal relationship between increased inflammation and high cholesterol in depression, as a single infusion of infliximab reduced cholesterol in TRD patients with high CRP compared to placebo.",2018,"Concentrations of cholesterol (total, LDL, HDL, non-HDL) were also lower at 2 weeks in patients treated with infliximab compared to placebo, but only in those patients with CRP >5 mg/L at baseline (all p < 0.05).","['TRD patients with high CRP', 'patients with treatment-resistant depression']","['infliximab', 'placebo']","['plasma biomarkers of glucose and lipid metabolism', 'depressive symptoms', 'baseline cholesterol (total, low-density lipoprotein [LDL], and non-high-density lipoprotein [non-HDL]), triglycerides and NEFA', 'Concentrations of cholesterol (total, LDL, HDL, non-HDL', 'HDL and non-HDL cholesterol concentrations', 'concentrations of glucose, insulin, and protein hormones that regulate glucose homeostasis and metabolism (leptin, resistin, and adiponectin), as well as cholesterols, triglycerides, and non-esterified fatty acids (NEFA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0682768', 'cui_str': 'Protein hormone'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0369212', 'cui_str': 'Fatty Acids, Esterified'}]",,0.065705,"Concentrations of cholesterol (total, LDL, HDL, non-HDL) were also lower at 2 weeks in patients treated with infliximab compared to placebo, but only in those patients with CRP >5 mg/L at baseline (all p < 0.05).","[{'ForeName': 'Mandakh', 'Initials': 'M', 'LastName': 'Bekhbat', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University, Atlanta, GA, 30322, United States.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University, Atlanta, GA, 30322, United States.'}, {'ForeName': 'Ngoc-Anh', 'Initials': 'NA', 'LastName': 'Le', 'Affiliation': 'Biomarker Core Laboratory, Atlanta VAMC, Decatur, GA, 30033, United States.'}, {'ForeName': 'Bobbi J', 'Initials': 'BJ', 'LastName': 'Woolwine', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University, Atlanta, GA, 30322, United States.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Haroon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University, Atlanta, GA, 30322, United States; The Winship Cancer Institute, Emory University, Atlanta, GA, 30322, United States.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University, Atlanta, GA, 30322, United States; The Winship Cancer Institute, Emory University, Atlanta, GA, 30322, United States.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Felger', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University, Atlanta, GA, 30322, United States; The Winship Cancer Institute, Emory University, Atlanta, GA, 30322, United States. Electronic address: jfelger@emory.edu.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2018.09.004']
3675,31076186,Functional remediation improves bipolar disorder functioning with no effects on brain-derived neurotrophic factor levels.,"The main aim of this study is to evaluate the impact of functional remediation (FR) in serum brain derived neurotrophic factor (BDNF) levels in euthymic adult patients with Bipolar Disorder (BD). A total of 128 participants were recruited at the Hospital Clinic of Barcelona. They were assessed at baseline and at the end of follow-up by the means of Hamilton Depression Scale (HAM-D), Young Mania Rating Scale (YMRS) and Functioning Assessment Short Test (FAST), as well as a clinical structured interview to collect clinical and demographic variables of interest. Blood samples were also collected to assess BDNF levels. After baseline assessment, patients received FR, Psychoeducation or treatment as usual (TAU). One hundred and two out of 126 participants finished the study distributed as follows: FR group (n = 39); Psychoeducation group (n = 47) and TAU group (n = 16). Longitudinal repeated-measures analyses addressing the treatment effect on BDNF levels showed non-significant differences between the three groups (Pillai's trace = 0.06; F (2,97) = 0.28; p = 0.75), suggesting no interaction between treatment allocation and time on BDNF levels. The results of this study suggest that FR has no effect on peripheral BDNF levels in euthymic patients with BD, despite the improvement in psychosocial functioning.",2019,"Longitudinal repeated-measures analyses addressing the treatment effect on BDNF levels showed non-significant differences between the three groups (Pillai's trace = 0.06; F (2,97) = 0.28; p = 0.75), suggesting no interaction between treatment allocation and time on BDNF levels.","['A total of 128 participants were recruited at the Hospital Clinic of Barcelona', 'euthymic adult patients with Bipolar Disorder (BD', 'One hundred and two out of 126 participants finished the study distributed as follows: FR group (n\u202f=\u202f39', 'euthymic patients with BD']","['FR, Psychoeducation or treatment as usual (TAU', 'Psychoeducation group (n\u202f=\u202f47) and TAU', 'functional remediation (FR', 'FR', 'Functional remediation']","['Hamilton Depression Scale (HAM-D), Young Mania Rating Scale (YMRS) and Functioning Assessment Short Test (FAST), as well as a clinical structured interview to collect clinical and demographic variables of interest', 'neurotrophic factor (BDNF) levels', 'peripheral BDNF levels', 'bipolar disorder functioning', 'BDNF levels']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0027754', 'cui_str': 'Neurotrophic Factors'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]",128.0,0.0926952,"Longitudinal repeated-measures analyses addressing the treatment effect on BDNF levels showed non-significant differences between the three groups (Pillai's trace = 0.06; F (2,97) = 0.28; p = 0.75), suggesting no interaction between treatment allocation and time on BDNF levels.","[{'ForeName': 'Caterina Del Mar', 'Initials': 'CDM', 'LastName': 'Bonnin', 'Affiliation': 'Barcelona Bipolar and Depressive Disorders Program, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clinic of Barcelona, Catalonia, Spain.'}, {'ForeName': 'Elia', 'Initials': 'E', 'LastName': 'Valls', 'Affiliation': 'Barcelona Bipolar and Depressive Disorders Program, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clinic of Barcelona, Catalonia, Spain.'}, {'ForeName': 'Adriane R', 'Initials': 'AR', 'LastName': 'Rosa', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Reinares', 'Affiliation': 'Barcelona Bipolar and Depressive Disorders Program, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clinic of Barcelona, Catalonia, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Jimenez', 'Affiliation': 'Barcelona Bipolar and Depressive Disorders Program, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clinic of Barcelona, Catalonia, Spain.'}, {'ForeName': 'Brisa', 'Initials': 'B', 'LastName': 'Solé', 'Affiliation': 'Barcelona Bipolar and Depressive Disorders Program, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clinic of Barcelona, Catalonia, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Montejo', 'Affiliation': 'Barcelona Bipolar and Depressive Disorders Program, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clinic of Barcelona, Catalonia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Meseguer', 'Affiliation': 'Barcelona Clinic Schizophrenia Unit, Hospital Clinic of Barcelona, Neuroscience Institute, University of Barcelona, Catalonia, Spain.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Pacchiarotti', 'Affiliation': 'Barcelona Bipolar and Depressive Disorders Program, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clinic of Barcelona, Catalonia, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Colom', 'Affiliation': ""Mental Health Group, IMIM (Institut Hospital del Mar d'Investigacions Mèdiques)-Hospital del Mar, CIBERSAM, Barcelona, Catalonia, Spain.""}, {'ForeName': 'Anabel', 'Initials': 'A', 'LastName': 'Martinez-Aran', 'Affiliation': 'Barcelona Bipolar and Depressive Disorders Program, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clinic of Barcelona, Catalonia, Spain. Electronic address: amartiar@clinic.ub.es.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Tomioka', 'Affiliation': 'Barcelona Bipolar and Depressive Disorders Program, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clinic of Barcelona, Catalonia, Spain.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Vieta', 'Affiliation': 'Barcelona Bipolar and Depressive Disorders Program, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clinic of Barcelona, Catalonia, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Torrent', 'Affiliation': 'Barcelona Bipolar and Depressive Disorders Program, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Hospital Clinic of Barcelona, Catalonia, Spain.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.04.002']
3676,31227666,Improving postural symmetry: The effectiveness of the CATCH (Combined Approach to Treatment for Children with Hemiplegia) protocol.,"PURPOSE


To evaluate postural symmetry in sitting and standing for children with hemiplegic cerebral palsy (hCP) following the Combined Approach to Treatment for Children with Hemiplegia (CATCH) protocol, an intervention combining Constraint Induced Movement Therapy, Bimanual Intensive Therapy and Neuro-Developmental Treatment.
METHODS


The study included 10 children with a diagnosis of hCP and 10 typically developing age-matched peers. Subjects participated in a CATCH camp for six hours daily for eight consecutive days. Postural symmetry measurements in quiet sitting and standing were obtained using a Boditrak pressure-mapping system at four time points: prior to start of camp (T1), first day of camp (T2), last day of camp (T3), and one month post-camp (T4).
RESULTS


Significant differences (p< 0.05) were found in quiet sitting when comparing postural symmetry pre-intervention and one-month post camp. In quiet standing, significant differences (p< 0.05) were found when pre-intervention was compared to one-month post-intervention. One month post-intervention, the intervention group showed no significant difference from the comparison group.
CONCLUSIONS


Children with hCP demonstrate improvement in postural symmetry in sitting and standing following participation in a CATCH camp. Following the intervention, children with hCP continued to improve postural symmetry and approach age-matched peers.",2019,"In quiet standing, significant differences (p< 0.05) were found when pre-intervention was compared to one-month post-intervention.","['10 children with a diagnosis of hCP and 10 typically developing age-matched peers', 'children with hemiplegic cerebral palsy (hCP', 'Children with Hemiplegia (CATCH', 'children with hemiplegia) protocol']","['CATCH camp', 'postural symmetry in sitting and standing', 'intervention combining Constraint Induced Movement Therapy, Bimanual Intensive Therapy and Neuro-Developmental Treatment', 'CATCH']","['quiet sitting', 'postural symmetry']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy (disorder)'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy (regime/therapy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}]","[{'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}]",10.0,0.0164673,"In quiet standing, significant differences (p< 0.05) were found when pre-intervention was compared to one-month post-intervention.","[{'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Holland', 'Affiliation': 'Rehabilitation Therapies, University of North Carolina Health Care, Chapel Hill, NC, USA.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Blazek', 'Affiliation': 'Rehabilitation Therapies, University of North Carolina Health Care, Chapel Hill, NC, USA.'}, {'ForeName': 'Margo Prim', 'Initials': 'MP', 'LastName': 'Haynes', 'Affiliation': 'NDT Pediatric Therapy, Adjunct Faculty UNC-CH in the Division of Physical Therapy, Rockingham, NC, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Dallman', 'Affiliation': 'Occupational Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Journal of pediatric rehabilitation medicine,['10.3233/PRM-180550']
3677,31119689,"Pharmacokinetic Drug Interactions Between Amlodipine, Valsartan, and Rosuvastatin in Healthy Volunteers.","INTRODUCTION


Amlodipine, valsartan, and rosuvastatin are among the medications widely coadministered for the treatment of hyperlipidemia accompanied by hypertension. The aim of this study was to investigate the possible pharmacokinetic drug-drug interactions between amlodipine, valsartan, and rosuvastatin in healthy Korean male volunteers.
METHODS


In this phase 1, open-label, multiple-dose, two-part, two-period, fixed-sequence study, the enrolled subjects were randomized into two parts (A and B). In part A (n = 32), each subject received one fixed-dose combination (FDC) tablet of amlodipine/valsartan 10 mg/160 mg alone for 10 consecutive days in period I, and the same FDC for 10 days with concomitant 7-day administration of 20 mg rosuvastatin in period II. In part B (n = 25), each subject received rosuvastatin alone for 7 days in period I, and the FDC for 10 days with concomitant 7-day administration of rosuvastatin in period II. In both parts, there was a 12-day washout between periods. Serial blood samples were collected for up to 72 h for amlodipine and rosuvastatin, and for up to 48 h for valsartan after the last dose of each period. The plasma concentrations of amlodipine, valsartan, and rosuvastatin were determined by using liquid chromatography-tandem mass spectrometry.
RESULTS


Fifty-seven subjects were enrolled; 30 and 25 subjects completed part A and part B, respectively. The geometric mean ratios and 90% confidence intervals for the maximum plasma concentration at steady state (C max,ss ) and the area under the plasma concentration-time curve over the dosing interval at steady state (AUC τ,ss ) were 0.9389 (0.9029-0.9763) and 0.9316 (0.8970-0.9675) for amlodipine, 0.7698 (0.6503-0.9114) and 0.7888 (0.6943-0.8962) for valsartan, and 0.9737 (0.8312-1.1407) and 0.9596 (0.8826-1.0433) for rosuvastatin, respectively. Of the 57 subjects enrolled in this study, 10 subjects experienced 13 adverse events (AEs); no severe or serious AEs were reported.
CONCLUSION


When amlodipine, valsartan, and rosuvastatin were coadministered to healthy volunteers, the pharmacokinetic exposure to valsartan was decreased, but no change in exposure to amlodipine and rosuvastatin occurred. All treatments were well tolerated.
CLINICAL TRIAL REGISTRATION


https://cris.nih.go.kr CRIS KCT0001660.
FUNDING


KyungDong Pharmaceutical Corp. Ltd., Seoul, Republic of Korea.",2019,"All treatments were well tolerated.
","['Fifty-seven subjects were enrolled; 30 and 25 subjects completed part A and part B, respectively', 'Healthy Volunteers', 'healthy volunteers', '57 subjects enrolled in this study, 10 subjects experienced 13', 'healthy Korean male volunteers']","['amlodipine and rosuvastatin, and for up to 48\xa0h for valsartan', 'Amlodipine, Valsartan, and Rosuvastatin', 'amlodipine, valsartan, and rosuvastatin', 'Amlodipine, valsartan, and rosuvastatin', 'amlodipine', 'valsartan, and 0.9737 ', 'amlodipine/valsartan', 'amlodipine and rosuvastatin', 'rosuvastatin', 'rosuvastatin alone']","['tolerated', 'geometric mean ratios', 'maximum plasma concentration at steady state (C max,ss ) and the area under the plasma concentration-time curve', 'pharmacokinetic exposure to valsartan', 'plasma concentrations of amlodipine, valsartan, and rosuvastatin', 'adverse events (AEs); no severe or serious AEs']","[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C1962523', 'cui_str': 'Amlodipine / valsartan'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",57.0,0.0172649,"All treatments were well tolerated.
","[{'ForeName': 'Sook Jin', 'Initials': 'SJ', 'LastName': 'Seong', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Boram', 'Initials': 'B', 'LastName': 'Ohk', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Woo Youl', 'Initials': 'WY', 'LastName': 'Kang', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Mi-Ri', 'Initials': 'MR', 'LastName': 'Gwon', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Bo Kyung', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Seungil', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Dong Heon', 'Initials': 'DH', 'LastName': 'Yang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Hae Won', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea. haewonbbc@gmail.com.'}, {'ForeName': 'Young-Ran', 'Initials': 'YR', 'LastName': 'Yoon', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea. yry@knu.ac.kr.'}]",Advances in therapy,['10.1007/s12325-019-00976-9']
3678,31272931,Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial.,"BACKGROUND


After acute coronary syndrome, diabetes conveys an excess risk of ischaemic cardiovascular events. A reduction in mean LDL cholesterol to 1·4-1·8 mmol/L with ezetimibe or statins reduces cardiovascular events in patients with an acute coronary syndrome and diabetes. However, the efficacy and safety of further reduction in LDL cholesterol with an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) after acute coronary syndrome is unknown. We aimed to explore this issue in a prespecified analysis of the ODYSSEY OUTCOMES trial of the PCSK9 inhibitor alirocumab, assessing its effects on cardiovascular outcomes by baseline glycaemic status, while also assessing its effects on glycaemic measures including risk of new-onset diabetes.
METHODS


ODYSSEY OUTCOMES was a randomised, double-blind, placebo-controlled trial, done at 1315 sites in 57 countries, that compared alirocumab with placebo in patients who had been admitted to hospital with an acute coronary syndrome (myocardial infarction or unstable angina) 1-12 months before randomisation and who had raised concentrations of atherogenic lipoproteins despite use of high-intensity statins. Patients were randomly assigned (1:1) to receive alirocumab or placebo every 2 weeks; randomisation was stratified by country and was done centrally with an interactive voice-response or web-response system. Alirocumab was titrated to target LDL cholesterol concentrations of 0·65-1·30 mmol/L. In this prespecified analysis, we investigated the effect of alirocumab on cardiovascular events by glycaemic status at baseline (diabetes, prediabetes, or normoglycaemia)-defined on the basis of patient history, review of medical records, or baseline HbA 1c  or fasting serum glucose-and risk of new-onset diabetes among those without diabetes at baseline. The primary endpoint was a composite of death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischaemic stroke, or unstable angina requiring hospital admission. ODYSSEY OUTCOMES is registered with ClinicalTrials.gov, number NCT01663402.
FINDINGS


At study baseline, 5444 patients (28·8%) had diabetes, 8246 (43·6%) had prediabetes, and 5234 (27·7%) had normoglycaemia. There were no significant differences across glycaemic categories in median LDL cholesterol at baseline (2·20-2·28 mmol/L), after 4 months' treatment with alirocumab (0·80 mmol/L), or after 4 months' treatment with placebo (2·25-2·28 mmol/L). In the placebo group, the incidence of the primary endpoint over a median of 2·8 years was greater in patients with diabetes (16·4%) than in those with prediabetes (9·2%) or normoglycaemia (8·5%); hazard ratio (HR) for diabetes versus normoglycaemia 2·09 (95% CI 1·78-2·46, p<0·0001) and for diabetes versus prediabetes 1·90 (1·65-2·17, p<0·0001). Alirocumab resulted in similar relative reductions in the incidence of the primary endpoint in each glycaemic category, but a greater absolute reduction in the incidence of the primary endpoint in patients with diabetes (2·3%, 95% CI 0·4 to 4·2) than in those with prediabetes (1·2%, 0·0 to 2·4) or normoglycaemia (1·2%, -0·3 to 2·7; absolute risk reduction p interaction =0·0019). Among patients without diabetes at baseline, 676 (10·1%) developed diabetes in the placebo group, compared with 648 (9·6%) in the alirocumab group; alirocumab did not increase the risk of new-onset diabetes (HR 1·00, 95% CI 0·89-1·11). HRs were 0·97 (95% CI 0·87-1·09) for patients with prediabetes and 1·30 (95% CI 0·93-1·81) for those with normoglycaemia (p interaction =0·11).
INTERPRETATION


After a recent acute coronary syndrome, alirocumab treatment targeting an LDL cholesterol concentration of 0·65-1·30 mmol/L produced about twice the absolute reduction in cardiovascular events among patients with diabetes as in those without diabetes. Alirocumab treatment did not increase the risk of new-onset diabetes.
FUNDING


Sanofi and Regeneron Pharmaceuticals.",2019,HRs were 0·97,"['patients with diabetes', 'acute coronary syndrome in patients with or without diabetes', 'patients with an acute coronary syndrome and diabetes', 'patients with prediabetes and 1·30', '5444 patients (28·8%) had diabetes, 8246 (43·6%) had prediabetes, and 5234 (27·7%) had normoglycaemia', 'patients who had been admitted to hospital with an acute coronary syndrome (myocardial infarction or unstable angina) 1-12 months before randomisation and who had raised concentrations of atherogenic lipoproteins despite use of high-intensity statins']","['alirocumab', 'ezetimibe or statins', 'alirocumab with placebo', 'placebo', 'alirocumab or placebo', 'Alirocumab']","['glycaemic categories in median LDL cholesterol', 'diabetes', 'risk of new-onset diabetes', 'composite of death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischaemic stroke, or unstable angina requiring hospital admission', 'mean LDL cholesterol', 'normoglycaemia', 'efficacy and safety', 'cardiovascular events', 'cardiovascular and metabolic outcomes', 'median of 2·8 years']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.567059,HRs were 0·97,"[{'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London, UK. Electronic address: k.ray@imperial.ac.uk.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'University of Edinburgh, Edinburgh, Scotland, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn, NY, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Baccara-Dinet', 'Affiliation': 'Sanofi, Montpellier, France.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Heart & Vascular Center, Brigham and Women's Hospital Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Andrzej J', 'Initials': 'AJ', 'LastName': 'Budaj', 'Affiliation': 'Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Cardiológicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada; St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Hanotin', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Loizeau', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Duke University, Durham, NC, USA.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Moryusef', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Murin', 'Affiliation': '1st Internal Department, Comenius University, University Hospital, Bratislava, Slovakia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'Arsen D', 'Initials': 'AD', 'LastName': 'Ristic', 'Affiliation': 'Department of Cardiology, Clinical Center of Serbia, Belgrade University School of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Tuñón', 'Affiliation': 'Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Hospital, Imperial College London, London, UK; Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université de Paris, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30158-5']
3679,31791416,A randomized trial comparing the Tennant Biomodulator to transcutaneous electrical nerve stimulation and traditional Chinese acupuncture for the treatment of chronic pain in military service members.,"BACKGROUND


The present investigation tested the efficacy of the Tennant Biomodulator, a novel pain management intervention that uses biofeedback-modulated electrical stimulation, to reduce chronic pain and its psychosocial sequelae in a sample of current and former military service members. The Tennant Biomodulator used on its most basic setting was compared to two commonly used, non-pharmacological pain treatments-traditional Chinese acupuncture and transcutaneous electrical nerve stimulation (TENS)-in a comparative efficacy, randomized, open-label trial.
METHODS


Participants included 100 active duty and retired service men and women with chronic pain undergoing treatment at the Brooke Army Medical Center in Texas, USA, randomly assigned to receive six, weekly sessions of either Tennant Biomodulator treatment, traditional Chinese acupuncture, or TENS, in addition to usual care. Recruitment was conducted between May 2010 to September 2013. Outcome measures were collected at intake, before and after each treatment session, and at a 1-month follow-up. Intent-to-treat analyses were used throughout, with mixed models used to investigate main effects of group, time, and group × time interactions with consideration given to quadratic effects. Outcomes measured included ratings of chronic pain, pain-related functional disability, and symptoms of post-traumatic stress disorder (PTSD) and depression.
RESULTS


On average, regardless of their treatment group, participants exhibited a 16% reduction in pain measured by the Brooke Army Medical Center's Clinic Pain Log [F(1, 335) = 55.7, P <  0.0001] and an 11% reduction in pain-related disability measured by the Million Visual Analog Scale [MVAS: F(1, 84) = 28.3, P <  0.0001] from baseline to the end of treatment, but no one treatment performed better than the other, and the reductions in pain and pain-related disability were largely lost by 1-month follow-up. Symptoms of PTSD and depression did not change significantly as a function of time or group.
CONCLUSIONS


Findings build on previous work suggesting that traditional Chinese acupuncture and TENS can reduce pain and its functional sequelae without risks associated with pharmacological pain management. The Tennant Biomodulator used on its most basic setting performs as well as these other interventions. Based on the present findings, large, randomized controlled trials on the Tennant Biomodulator are indicated. Future work should test this device using its full range of settings for pain-related psychological health.
TRIAL REGISTRATION


Clincialtrials.gov (NCT01752010); registered December 14, 2012.",2019,"On average, regardless of their treatment group, participants exhibited a 16% reduction in pain measured by the Brooke Army Medical Center's Clinic Pain Log [F(1, 335) = 55.7, P <  0.0001] and an 11% reduction in pain-related disability measured by the Million Visual Analog Scale [MVAS: F(1, 84) = 28.3, P <  0.0001] from baseline to the end of treatment, but no one treatment performed better than the other, and the reductions in pain and pain-related disability were largely lost by 1-month follow-up.","['Participants included 100 active duty and retired service men and women with chronic pain undergoing treatment at the Brooke Army Medical Center in Texas, USA', 'chronic pain in military service members']","['Chinese acupuncture and transcutaneous electrical nerve stimulation (TENS)-in', 'traditional Chinese acupuncture and TENS', 'Tennant Biomodulator to transcutaneous electrical nerve stimulation and traditional Chinese acupuncture', 'Tennant Biomodulator treatment, traditional Chinese acupuncture, or TENS, in addition to usual care']","['Symptoms of PTSD and depression', 'pain and pain-related disability', 'pain', 'ratings of chronic pain, pain-related functional disability, and symptoms of post-traumatic stress disorder (PTSD) and depression', 'chronic pain', 'pain-related disability']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}]","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C0005525', 'cui_str': 'Biological Response Modifiers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",100.0,0.0850316,"On average, regardless of their treatment group, participants exhibited a 16% reduction in pain measured by the Brooke Army Medical Center's Clinic Pain Log [F(1, 335) = 55.7, P <  0.0001] and an 11% reduction in pain-related disability measured by the Million Visual Analog Scale [MVAS: F(1, 84) = 28.3, P <  0.0001] from baseline to the end of treatment, but no one treatment performed better than the other, and the reductions in pain and pain-related disability were largely lost by 1-month follow-up.","[{'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Peacock', 'Affiliation': 'University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Stoerkel', 'Affiliation': 'TLI Foundation, 1750 Tysons Boulevard, McLean, Virginia, 22102, USA.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Libretto', 'Affiliation': 'Henry M. Jackson Foundation, 6720A Rockledge Drive, Bethesda, MD, 20817, USA.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'BD Life Sciences, 1 Becton Drive, Franklin Lakes, NJ, 07417, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Inman', 'Affiliation': 'Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, TX, 78234, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schlicher', 'Affiliation': 'Madigan Army Medical Center, 9040A Jackson Ave, Joint Base Lewis-McChord, WA, 98431, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Cowsar', 'Affiliation': 'MedPost Urgent Care Center, 513 Cibolo Valley Drive, Cibolo, TX, 78108, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Eddie', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, 151 Merrimac St. 6th Floor, Boston, MA, 02114, USA. deddie@mgh.harvard.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': 'H&S Ventures, Samueli Integrative Health Program, 1800 Diagonal Road, Suite 617, Alexandria, VA, 22314, USA.'}]",Military Medical Research,['10.1186/s40779-019-0227-4']
3680,31221304,Complications of Peripheral Vascular Intervention: Time to Stop the Bleeding.,,2019,,[],['Peripheral Vascular\xa0Intervention'],['Time to Stop the Bleeding'],[],"[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]",,0.0157452,,"[{'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Drachman', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts. Electronic address: ddrachman@partners.org.'}, {'ForeName': 'Beau M', 'Initials': 'BM', 'LastName': 'Hawkins', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.04.021']
3681,31230147,"The combination of wheat peptides and fucoidan protects against chronic superficial gastritis and alters gut microbiota: a double-blinded, placebo-controlled study.","PURPOSE


Chronic gastritis is observed in almost half world population. Traditional medications against chronic gastritis might produce adverse effects, so alternative nutritional strategies are needed to prevent the aggravation of gastric mucosal damage. The aim of this study is to evaluate the protective effect of the combination of wheat peptides and fucoidan (WPF) on adults diagnosed with chronic superficial gastritis in a randomized, double-blind, placebo-controlled clinical trial.
METHODS


Participants were randomized to receive WPF (N = 53) or placebo (N = 53) once daily for 45 days. Pathological grading of gastric mucosal damage was scored using gastroscopy. Fecal samples were collected for the determination of calprotectin, short chain fatty acids (SCFA) levels and metagenomics analysis. Questionnaires for self-reported gastrointestinal discomforts, life quality and food frequency were collected throughout the study.
RESULTS


WPF intervention reduced gastric mucosal damage in 70% subjects (P < 0.001). Significantly less stomach pain (P < 0.001), belching (P = 0.028), bloating (P < 0.001), acid reflux (P < 0.001), loss of appetite (P = 0.021), increased food intake (P = 0.020), and promoted life quality (P = 0.014) were reported in the WPF group. WPF intervention significantly decreased fecal calprotectin level (P = 0.003) while slightly increased fecal SCFAs level (P = 0.092). In addition, we found altered microbiota composition post-intervention with increased Bifidobacterium pseudocatenulatum (P = 0.032), Eubacterium siraeum (P = 0.036), Bacteroides intestinalis (P = 0.024) and decreased Prevotella copri (P = 0.055).
CONCLUSIONS


WPF intervention could be utilized as a nutritional alternative to mitigate the progression of chronic gastritis. Furthermore, WPF played an important role in altering gut microbial profile and SCFA production, which might benefit the lower gastrointestinal tract.",2020,"Significantly less stomach pain (P < 0.001), belching (P = 0.028), bloating (P < 0.001), acid reflux (P < 0.001), loss of appetite (P = 0.021), increased food intake (P = 0.020), and promoted life quality (P = 0.014) were reported in the WPF group.","['adults diagnosed with chronic superficial gastritis', 'Participants']","['WPF intervention', 'wheat peptides and fucoidan (WPF', 'placebo', 'WPF', 'wheat peptides and fucoidan']","['fecal SCFAs level', 'bloating', 'loss of appetite', 'Bacteroides intestinalis', 'acid reflux', 'life quality', 'Eubacterium siraeum', 'fecal calprotectin level', 'food intake', 'Questionnaires for self-reported gastrointestinal discomforts, life quality and food frequency', 'Pathological grading of gastric mucosal damage', 'stomach pain', 'belching', 'gastric mucosal damage', 'chronic superficial gastritis and alters gut microbiota']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348893', 'cui_str': 'Chronic superficial gastritis (disorder)'}]","[{'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0060794', 'cui_str': 'fucan sulfate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0856449', 'cui_str': 'Acid reflux (oesophageal)'}, {'cui': 'C0034380'}, {'cui': 'C0317501', 'cui_str': 'Eubacterium siraeum (organism)'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0221512', 'cui_str': 'Stomach ache (finding)'}, {'cui': 'C0014724', 'cui_str': 'Belching'}, {'cui': 'C0348893', 'cui_str': 'Chronic superficial gastritis (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]",70.0,0.300088,"Significantly less stomach pain (P < 0.001), belching (P = 0.028), bloating (P < 0.001), acid reflux (P < 0.001), loss of appetite (P = 0.021), increased food intake (P = 0.020), and promoted life quality (P = 0.014) were reported in the WPF group.","[{'ForeName': 'Juntao', 'Initials': 'J', 'LastName': 'Kan', 'Affiliation': 'Nutrilite Health Institute, Amway R&D Center, 720 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Junrui', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Nutrilite Health Institute, Amway R&D Center, 720 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Leiming', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, 200092, China.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Hood', 'Affiliation': 'Nutrilite Health Institute, Amway R&D Center, Ada, MI, 49355, USA.'}, {'ForeName': 'Dingfu', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': 'Department of Gastroenterology, Jinhua Wenrong Hospital, Jinhua, 321013, Zhejiang, China.'}, {'ForeName': 'Meijiao', 'Initials': 'M', 'LastName': 'Cheng', 'Affiliation': 'QuantiHealth, Beijing, 100070, China.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Nutrilite Health Institute, Amway R&D Center, 720 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Nutrilite Health Institute, Amway R&D Center, 720 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Nutrilite Health Institute, Amway R&D Center, 720 Cailun Road, Shanghai, 201203, China. Eric.du@amway.com.'}]",European journal of nutrition,['10.1007/s00394-019-02020-6']
3682,31174224,Endocuff-assisted colonoscopy for surveillance of serrated polyposis syndrome: a multicenter randomized controlled trial.,"BACKGROUND AND STUDY AIMS


Serrated polyposis syndrome (SPS) is a condition with high risk for colorectal cancer. The Endocuff device has been shown to increase adenoma detection in the general and screening population. We aimed to ascertain whether Endocuff-assisted colonoscopy increases detection of serrated lesions in comparison with standard colonoscopy during the surveillance of patients with SPS.  METHODS:  In a multicenter randomized controlled study, patients who met SPS criteria I and/or III under surveillance (previous resection of all serrated lesions ≥ 4 mm) were consecutively randomly allocated 1:1 to Endocuff-assisted colonoscopy or standard colonoscopy, performed by expert endoscopists. The main outcome was the mean number of serrated lesions detected per patient.
RESULTS


122 patients (standard colonoscopy n = 60; Endocuff-assisted colonoscopy n = 62; 59 % men; mean age 60.6 (standard deviation [SD] 7.5) were included at 4 centers. Baseline variables (demographic data, SPS phenotype, colorectal cancer [CRC] history, cumulative polyps, and follow-up), cecal intubation rate, and withdrawal time were similar between groups. There was no statistically significant difference between Endocuff-assisted colonoscopy and standard colonoscopy for the mean number of serrated lesions detected per patient: 5.8 (95 % confidence interval [95 %CI] 4.4 - 7.2) and 5.0 (3.9 - 6.1), respectively ( P  = 0.36). There were also no differences between Endocuff-assisted and standard colonoscopy for detection of sessile serrated lesions (mean number per patient 2.5 [1.3 - 3.6] vs. 2.0 [1.1 - 3.0],  P  = 0.54) and adenomas (0.9 [0.5 - 1.3] vs. 0.5 [0.3 - 0.7],  P  = 0.12).
CONCLUSION


Use of Endocuff-assisted colonoscopy did not significantly increase the number of serrated lesion detected per patient during surveillance of SPS.",2019,"There was no statistically significant difference between Endocuff-assisted colonoscopy and standard colonoscopy for the mean number of serrated lesions detected per patient: 5.8 (95 % confidence interval [95 %CI] 4.4 - 7.2) and 5.0 (3.9 - 6.1), respectively ( P  = 0.36).","['serrated polyposis syndrome', 'patients who met SPS criteria I and/or III under surveillance (previous resection of all serrated lesions ≥\u200a4\u200amm', '122 patients (standard colonoscopy n\u200a=\u200a60; Endocuff-assisted colonoscopy n\u200a=\u200a62; 59\u200a% men; mean age 60.6 (standard deviation [SD] 7.5) were included at 4 centers', 'patients with SPS']","['standard colonoscopy', 'Endocuff-assisted colonoscopy or standard colonoscopy', 'Endocuff-assisted colonoscopy']","['mean number of serrated lesions detected per patient', 'Baseline variables (demographic data, SPS phenotype, colorectal cancer [CRC] history, cumulative polyps, and follow-up), cecal intubation rate, and withdrawal time', 'Endocuff-assisted colonoscopy and standard colonoscopy for the mean number of serrated lesions', 'Endocuff-assisted and standard colonoscopy for detection of sessile serrated lesions', 'number of serrated lesion']","[{'cui': 'C0334108', 'cui_str': 'Multiple polyps (morphologic abnormality)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4255078', 'cui_str': 'SPS'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C4255078', 'cui_str': 'SPS'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205348', 'cui_str': 'Sessile (qualifier value)'}]",122.0,0.297438,"There was no statistically significant difference between Endocuff-assisted colonoscopy and standard colonoscopy for the mean number of serrated lesions detected per patient: 5.8 (95 % confidence interval [95 %CI] 4.4 - 7.2) and 5.0 (3.9 - 6.1), respectively ( P  = 0.36).","[{'ForeName': 'Liseth', 'Initials': 'L', 'LastName': 'Rivero-Sánchez', 'Affiliation': ""Hospital Clinic de Barcelona, Department of Gastroenterology, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Center for Biomedical Research in the Hepatic and Digestive Diseases Network (CIBERehd), Barcelona, Spain.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'López Vicente', 'Affiliation': 'Hospital Universitario de Móstoles, Digestive System Service, Móstoles, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Hernandez Villalba', 'Affiliation': 'Hospital Santos Reyes, Digestive System Service, Aranda de Duero, Spain.'}, {'ForeName': 'Ignasi', 'Initials': 'I', 'LastName': 'Puig', 'Affiliation': 'Althaia, Xarxa Assistencial Universitària de Manresa, Digestive System Service, Manresa, Spain.'}, {'ForeName': 'Coral', 'Initials': 'C', 'LastName': 'Arnau-Collell', 'Affiliation': ""Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': ""Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Díaz', 'Affiliation': ""Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rodriguez de Miguel', 'Affiliation': 'Hospital Clinic de Barcelona, Digestive Endoscopy Unit, Barcelona, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Ocaña', 'Affiliation': 'Hospital Clinic de Barcelona, Department of Gastroenterology, Barcelona, Spain.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Moreira', 'Affiliation': ""Hospital Clinic de Barcelona, Department of Gastroenterology, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Center for Biomedical Research in the Hepatic and Digestive Diseases Network (CIBERehd), Barcelona, Spain.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Cuatrecasas', 'Affiliation': 'Hospital Clinic de Barcelona, Department of Pathology, Barcelona, Spain.'}, {'ForeName': 'Sabela', 'Initials': 'S', 'LastName': 'Carballal', 'Affiliation': ""Hospital Clinic de Barcelona, Department of Gastroenterology, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Center for Biomedical Research in the Hepatic and Digestive Diseases Network (CIBERehd), Barcelona, Spain.""}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Sánchez', 'Affiliation': ""Hospital Clinic de Barcelona, Department of Gastroenterology, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Center for Biomedical Research in the Hepatic and Digestive Diseases Network (CIBERehd), Barcelona, Spain.""}, {'ForeName': 'Oswaldo', 'Initials': 'O', 'LastName': 'Ortiz', 'Affiliation': 'Hospital Clinic de Barcelona, Department of Gastroenterology, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Llach', 'Affiliation': 'Hospital Clinic de Barcelona, Digestive Endoscopy Unit, Barcelona, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Balaguer', 'Affiliation': ""Hospital Clinic de Barcelona, Department of Gastroenterology, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Center for Biomedical Research in the Hepatic and Digestive Diseases Network (CIBERehd), Barcelona, Spain.""}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Pellisé', 'Affiliation': ""Hospital Clinic de Barcelona, Department of Gastroenterology, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Center for Biomedical Research in the Hepatic and Digestive Diseases Network (CIBERehd), Barcelona, Spain.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Endoscopy,['10.1055/a-0925-4956']
3683,31925833,"A randomized, controlled, behavioral intervention to promote walking after abdominal organ transplantation: results from the LIFT study.","Kidney transplant recipients (KTRs) and liver transplant recipients (LTRs) have significant post-transplant weight gain and low physical activity. We conducted a home-based, remotely monitored intervention using wearable accelerometer devices to promote post-transplant physical activity. We randomized 61 KTRs and 66 LTRs within 24 months of transplant to: (i) control, (ii) accelerometer or (iii) intervention: accelerometer paired with financial incentives and health engagement questions to increase steps by 15% from baseline every 2 weeks. The primary outcome was weight change. A co-primary outcome for the two accelerometer arms was steps. Participants were recruited at a median of 9.5 [3-17] months post-transplant. At 3 months, there were no significant differences in weight change across the three arms. The intervention arm was more likely to achieve ≥7000 steps compared to control with device (OR 1.99, 95% CI: 1.03-3.87); effect remained significant after adjusting for demographics, allograft, time from transplant and baseline weight. Adherence to target step goals was 74% in the intervention arm, 84% of health engagement questions were answered correctly. A pilot study with financial incentives and health engagement questions was feasible and led KTRs and LTRs to walk more, but did not affect weight. A definitive trial is warranted.",2020,"The intervention arm was more likely to achieve ≥7000 steps compared to control with device (OR 1.99, 95% CI:1.03-3.87); effect remained significant after adjusting for demographics, allograft, time from transplant, and baseline weight.","['after Abdominal Organ Transplantation', 'Participants were recruited at a median of 9.5 [3-17] months post-transplant', 'Kidney transplant recipients (KTRs) and liver transplant recipients (LTRs']","['Behavioral Intervention to Promote Walking', 'control, 2) accelerometer, or 3) intervention: accelerometer paired with financial incentives and health engagement questions']",['weight change'],"[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0029216', 'cui_str': 'Grafting, Organ'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C3811922', 'cui_str': 'Transplanted liver present (finding)'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",,0.101783,"The intervention arm was more likely to achieve ≥7000 steps compared to control with device (OR 1.99, 95% CI:1.03-3.87); effect remained significant after adjusting for demographics, allograft, time from transplant, and baseline weight.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Serper', 'Affiliation': 'Division of Gastroenterology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Iwan', 'Initials': 'I', 'LastName': 'Barankay', 'Affiliation': 'The Wharton School, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sakshum', 'Initials': 'S', 'LastName': 'Chadha', 'Affiliation': 'Renal-Electrolyte and Hypertension Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Shults', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Jones', 'Affiliation': 'Division of Gastroenterology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Olthoff', 'Affiliation': 'Department of Surgery, Division of Transplant Surgery, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Reese', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13570']
3684,31189517,"Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial.","BACKGROUND


Oral semaglutide is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist for glycaemic control in patients with type 2 diabetes. Type 2 diabetes is commonly associated with renal impairment, restricting treatment options. We aimed to investigate the efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment.
METHODS


This randomised, double-blind, phase 3a trial was undertaken at 88 sites in eight countries. Patients aged 18 years and older, with type 2 diabetes, an estimated glomerular filtration rate of 30-59 mL/min per 1·73 m 2 , and who had been receiving a stable dose of metformin or sulfonylurea, or both, or basal insulin with or without metformin for the past 90 days were eligible. Participants were randomly assigned (1:1) by use of an interactive web-response system, with stratification by glucose-lowering medication and renal function, to receive oral semaglutide (dose escalated to 14 mg once daily) or matching placebo for 26 weeks, in addition to background medication. Participants and site staff were masked to assignment. Two efficacy-related estimands were defined: treatment policy (regardless of treatment discontinuation or rescue medication) and trial product (on treatment without rescue medication) in all participants randomly assigned. Endpoints were change from baseline to week 26 in HbA 1c  (primary endpoint) and bodyweight (confirmatory secondary endpoint), assessed in all participants with sufficient data. Safety was assessed in all participants who received at least one dose of study drug. This trial is registered on ClinicalTrials.gov, number NCT02827708, and the European Clinical Trials Registry, number EudraCT 2015-005326-19, and is now complete.
FINDINGS


Between Sept 20, 2016, and Sept 29, 2017, of 721 patients screened, 324 were eligible and randomly assigned to oral semaglutide (n=163) or placebo (n=161). Mean age at baseline was 70 years (SD 8), and 168 (52%) of participants were female. 133 (82%) participants in the oral semaglutide group and 141 (88%) in the placebo group completed 26 weeks on treatment. At 26 weeks, oral semaglutide was superior to placebo in decreasing HbA 1c  (estimated mean change of -1·0 percentage point (SE 0·1; -11 mmol/mol [SE 0·8]) vs -0·2 percentage points (SE 0·1; -2 mmol/mol [SE 0·8]); estimated treatment difference [ETD]: -0·8 percentage points, 95% CI -1·0 to -0·6; p<0·0001) and bodyweight (estimated mean change of -3·4 kg [SE 0·3] vs -0·9 kg [SE 0·3]; ETD, -2·5, 95% CI -3·2 to -1·8; p<0·0001) by the treatment policy estimand. Significant differences were seen for the trial product estimand: mean change in HbA 1c  -1·1 percentage points (SE 0·1; -12 mmol/mol [SE 0·8] versus -0·1 percentage points (SE 0·1; -1 mmol/mol [SE 0·8]; ETD -1·0 percentage points, 95% CI -1·2 to -0·8; p<0·0001); mean change in bodyweight -3·7 kg (SE 0·3) versus -1·1 kg (SE 0·3; ETD -2·7 kg, 95% CI -3·5 to -1·9; p<0·0001). More patients taking oral semaglutide than placebo had adverse events (120 [74%] of 163 vs 105 [65%] of 161), and discontinued treatment as a result (24 [15%] vs eight [5%]). Gastrointestinal events, mainly mild-to-moderate nausea, were more common with oral semaglutide than with placebo. Three deaths occurred during the treatment period that were not condsidered to be treatment related, one in the semaglutide group and two in the placebo group.
INTERPRETATION


Oral semaglutide was effective in patients with type 2 diabetes and moderate renal impairment, potentially providing a new treatment option for this population. Safety, including renal safety, was consistent with the GLP-1 receptor agonist class.
FUNDING


Novo Nordisk A/S.",2019,"At 26 weeks, oral semaglutide was superior to placebo in decreasing HbA 1c  (estimated mean change of -1·0 percentage point (SE 0·1; -11 mmol/mol [SE 0·8])","['patients with type 2 diabetes and moderate renal impairment', 'Patients aged 18 years and older, with type 2 diabetes, an estimated glomerular filtration rate of 30-59 mL/min per 1·73 m 2 , and who had been receiving a stable dose of metformin or sulfonylurea, or both, or basal insulin with or without metformin for the past 90 days were eligible', 'Between Sept 20, 2016, and Sept 29, 2017, of 721 patients screened, 324 were eligible and randomly assigned to', 'participants who received at least one dose of study drug', 'Mean age at baseline was 70 years (SD 8), and 168 (52%) of participants were female', '88 sites in eight countries', 'patients with type 2 diabetes']","['GLP-1) receptor agonist', 'oral semaglutide', 'placebo', 'interactive web-response system, with stratification by glucose-lowering medication and renal function, to receive oral semaglutide (dose escalated to 14 mg once daily) or matching placebo']","['Gastrointestinal events, mainly mild-to-moderate nausea', 'renal safety', 'adverse events', 'Efficacy and safety', 'efficacy and safety', 'deaths', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3811844'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",324.0,0.63011,"At 26 weeks, oral semaglutide was superior to placebo in decreasing HbA 1c  (estimated mean change of -1·0 percentage point (SE 0·1; -11 mmol/mol [SE 0·8])","[{'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Division of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel. Electronic address: ofrim@hadassah.org.il.'}, {'ForeName': 'Thalia Marie', 'Initials': 'TM', 'LastName': 'Blicher', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Rosenlund', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Eriksson', 'Affiliation': 'Clinical Diabetology and Metabolism, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Heller', 'Affiliation': 'Academic Unit of Diabetes, Endocrinology and Metabolism, Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ole Holm', 'Initials': 'OH', 'LastName': 'Hels', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute for Metabolism and Diabetes, Orlando, FL, USA.'}, {'ForeName': 'Thozhukat', 'Initials': 'T', 'LastName': 'Sathyapalan', 'Affiliation': 'Academic Diabetes, Endocrinology and Metabolism Research Group, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Desouza', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30192-5']
3685,31249253,"Premedication effect of melatonin on propofol induction dose for anesthesia, anxiety, orientation and sedation after abdominal surgery: a double-blinded randomized trial.","The present study addressed the effect of melatonin premedication on propofol induction dose for anesthesia in abdominal surgery. This is a double-blinded clinical trial in which abdominal surgery patients admitted to the Valiasr Hospital, Iran (n = 88) were enrolled and individually randomized into two groups: melatonin and placebo groups sublingually administered 3 mg of melatonin and placebo, respectively, 50 minutes before surgery. Their anxiety, orientation, and sedation were recorded before melatonin administration, anesthesia induction, and recovery, while we also recorded the propofol induction dose required for general anesthesia. Anxiety was seen less in the melatonin group than the placebo group (P < 0.05), whereas orientation was significantly different before anesthesia induction (P = 0.044) and sedation was the same before the induction (P = 0.044) and recovery (P = 0.049) in both groups, with a better efficiency in the melatonin group in which a lower dose of propofol was used (P = 0.002). The sedation, anxiety, and propofol dose used were lower in the melatonin group than the placebo group. The recommended dosage was 3 mg of melatonin once to achieve an anesthetic depth index or a bispectral index of 40. The study was approved by Ethical Committee of Arak University of Medical Sciences with IR.ARAKMU.REC.1395.432 code in July 2016, and the trial was registered in Iranian Registry of Clinical Trials with IRCT20141209020258N98 in September 2016.",2019,"Anxiety was seen less in the melatonin group than the placebo group (P < 0.05), whereas orientation was significantly different before anesthesia induction (P = 0.044) and sedation was the same before the induction (P = 0.044) and recovery (P = 0.049) in both groups, with a better efficiency in the melatonin group in which a lower dose of propofol was used (P = 0.002).","['Arak University of Medical Sciences with IR.ARAKMU.REC.1395.432 code in July 2016, and the trial was registered in Iranian Registry of Clinical Trials with IRCT20141209020258N98 in September 2016', 'abdominal surgery patients admitted to the Valiasr Hospital, Iran (n = 88', 'after abdominal surgery', 'anesthesia in abdominal surgery']","['melatonin', 'placebo', 'propofol', 'melatonin and placebo groups sublingually administered 3 mg of melatonin and placebo', 'melatonin premedication']","['Their anxiety, orientation, and sedation', 'anesthesia, anxiety, orientation and sedation', 'Anxiety']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}]","[{'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",88.0,0.243036,"Anxiety was seen less in the melatonin group than the placebo group (P < 0.05), whereas orientation was significantly different before anesthesia induction (P = 0.044) and sedation was the same before the induction (P = 0.044) and recovery (P = 0.049) in both groups, with a better efficiency in the melatonin group in which a lower dose of propofol was used (P = 0.002).","[{'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Norouzi', 'Affiliation': 'Department of Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Fateh', 'Affiliation': 'Department of surgery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Hesameddin', 'Initials': 'H', 'LastName': 'Modir', 'Affiliation': 'Department of Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Kamali', 'Affiliation': 'Department of Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Akrami', 'Affiliation': 'Department of Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran.'}]",Medical gas research,['10.4103/2045-9912.260646']
3686,30621974,Assessment of Platelet REACtivity After Transcatheter Aortic Valve Replacement: The REAC-TAVI Trial.,"OBJECTIVES


The REAC-TAVI (Assessment of platelet REACtivity after Transcatheter Aortic Valve Implantation) trial enrolled patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) pre-treated with aspirin + clopidogrel, aimed to compare the efficacy of clopidogrel and ticagrelor in suppressing high platelet reactivity (HPR) after TAVI.
BACKGROUND


Current recommendations support short-term use of aspirin + clopidogrel for patients with severe AS undergoing TAVR despite the lack of compelling evidence.
METHODS


This was a prospective, randomized, multicenter investigation. Platelet reactivity was measured at 6 different time points with the VerifyNow assay (Accriva Diagnostics, San Diego, California). HPR was defined as (P2Y 12  reaction units (PRU) ≥208. Patients with HPR before TAVR were randomized to either aspirin + ticagrelor or aspirin + clopidogrel for 3 months. Patients without HPR continued with aspirin + clopidogrel (registry cohort). The primary endpoint was non-HPR status (PRU <208) in ≥70% of patients treated with ticagrelor at 90 days post-TAVR.
RESULTS


A total of 68 patients were included. Of these, 48 (71%) had HPR (PRU 273 ± 09) and were randomized to aspirin + ticagrelor (n = 24, PRU 277 ± 08) or continued with aspirin + clopidogrel (n = 24, PRU 269 ± 49). The remaining 20 patients (29%) without HPR (PRU 133 ± 12) were included in the registry. Overall, platelet reactivity across all the study time points after TAVR was lower in patients randomized to ticagrelor compared with those treated with clopidogrel, including those enrolled in the registry (p < 0.001). The primary endpoint was achieved in 100% of patients with ticagrelor compared with 21% with clopidogrel (p < 0.001). Interestingly, 33% of clopidogrel responder patients at baseline developed HPR status during the first month after TAVR.
CONCLUSIONS


HPR to clopidogrel is present in a considerable number of patients with AS undergoing TAVR. Ticagrelor achieves a better and faster effect, providing sustained suppression of HPR to these patients. (Platelet Reactivity After TAVI: A Multicenter Pilot Study [REAC-TAVI]; NCT02224066).",2019,"Overall, platelet reactivity across all the study time points after TAVR was lower in patients randomized to ticagrelor compared with those treated with clopidogrel, including those enrolled in the registry (p < 0.001).","['Patients without HPR continued with', 'Transcatheter Aortic Valve Implantation) trial enrolled patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) pre-treated with', 'patients with AS undergoing TAVR', 'patients with severe AS undergoing TAVR', '20 patients (29%) without HPR (PRU 133 ± 12) were included in the registry', '48 (71%) had HPR (PRU 273 ± 09', 'Patients with HPR before TAVR', 'A total of 68 patients were included']","['clopidogrel and ticagrelor', 'Transcatheter Aortic Valve Replacement', 'aspirin\xa0+ clopidogrel', 'ticagrelor', 'Ticagrelor', 'aspirin\xa0+ ticagrelor', 'TAVI', 'aspirin\xa0+ ticagrelor or aspirin\xa0+ clopidogrel', 'clopidogrel']","['platelet reactivity', 'Platelet Reactivity', 'non-HPR status', 'HPR', 'Platelet REACtivity', 'HPR status', 'Platelet reactivity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter Aortic Valve Implantation'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",68.0,0.0594887,"Overall, platelet reactivity across all the study time points after TAVR was lower in patients randomized to ticagrelor compared with those treated with clopidogrel, including those enrolled in the registry (p < 0.001).","[{'ForeName': 'Victor Alfonso', 'Initials': 'VA', 'LastName': 'Jimenez Diaz', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain; Cardiovascular Research Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain. Electronic address: victor.alfonso.jimenez.diaz@sergas.es.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Tello-Montoliu', 'Affiliation': 'Cardiology Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Murcia, Spain; Centro de Investigación en Red de Enfermedades Cardiovasculares (Network Research Center for Cardiovascular Diseases), CIBER-CV, Madrid, Spain.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'Cardiology Department, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Cruz Gonzalez', 'Affiliation': 'Centro de Investigación en Red de Enfermedades Cardiovasculares (Network Research Center for Cardiovascular Diseases), CIBER-CV, Madrid, Spain; Cardiology Department, Hospital Universitario de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Baz Alonso', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romaguera', 'Affiliation': 'Cardiology Department, Hospital Universitario de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Molina Navarro', 'Affiliation': 'Cardiology Department, Hospital Universitario Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Juan Salvadores', 'Affiliation': 'Cardiovascular Research Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain; Cardiovascular Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Paredes Galan', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'De Miguel Castro', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Bastos Fernandez', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ortiz Saez', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Saleta', 'Initials': 'S', 'LastName': 'Fernandez Barbeira', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Raposeiras Roubin', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Ocampo Miguez', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Serra Peñaranda', 'Affiliation': 'Cardiology Department, Hospital Universitario San Pau, Barcelona, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Valdes Chavarri', 'Affiliation': 'Cardiology Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Murcia, Spain; Centro de Investigación en Red de Enfermedades Cardiovasculares (Network Research Center for Cardiovascular Diseases), CIBER-CV, Madrid, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Cequier Fillat', 'Affiliation': 'Centro de Investigación en Red de Enfermedades Cardiovasculares (Network Research Center for Cardiovascular Diseases), CIBER-CV, Madrid, Spain; Cardiology Department, Hospital Universitario de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Calvo Iglesias', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Iñiguez Romo', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain; Centro de Investigación en Red de Enfermedades Cardiovasculares (Network Research Center for Cardiovascular Diseases), CIBER-CV, Madrid, Spain.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2018.10.005']
3687,31207030,"Effect of tadalafil 5 mg on post-micturition dribble in men with lower urinary tract symptoms: a multicentre, double-blind, randomized, placebo-controlled trial.","OBJECTIVES


To compare the effects of taking tadalafil 5 mg and placebo once daily on post-micturition dribble (PMD) in men with lower urinary tract symptoms (LUTS).
PATIENTS AND METHODS


Our prospective, randomized, double-blind, placebo-controlled, multicentre trial enrolled 102 men with PMD and other LUTS. PMD was assessed using the Hallym Post-Micturition Dribble Questionnaire (HPMDQ) and according to PMD volume. Over a 12-week period, patients took either tadalafil 5 mg (n = 51) or placebo (n = 51) once daily and their HPMDQ and PMD volume results were evaluated. Adverse events (AEs) were also reported.
RESULTS


Over the course of 12 weeks, total HPMDQscores and PMD volumes improved significantly more in the tadalafil group than in the placebo group (reduction of total HPMDQ score of ≥2 points in the tadalafil and placebo group in 68.8% and 31.9% of patients (P < 0.001) and decreased mean PMD volume in the tadalafil and placebo group at 0.48 mL and 0.22  mL, respectively (P = 0.046). Specifically, PMD frequency decreased and quality of life increased significantly more in the tadalafil group than in the placebo group (P = 0.029 and P < 0.001, respectively). Furthermore, 66.7% of the tadalafil group reported moderate and significant PMD improvement, whereas only 4.2% reported that tadalafil was ineffective. Treatment-emergent AEs did not significantly differ between the groups (all P > 0.05), and no serious AEs were observed.
CONCLUSION


Taking tadalafil 5 mg once daily reduced PMD symptom severity and PMD volume in men with PMD, without inducing serious AEs, more effectively than placebo, suggesting that taking tadalafil 5 mg once daily may be an effective and well-tolerated PMD treatment.",2019,"Over 12 weeks, the total HPMDQ scores and PMD volumes improved significantly more in the tadalafil group than in the placebo group (reduction of total HPMDQ score by ≥ 2 points in the tadalafil and placebo group in 68.8% and 31.9% of patients, p < 0.001 and decreased mean PMD volume in the tadalafil and placebo group at 0.48 mL and 0.22 mL, p = 0.046, respectively).","['men with lower urinary tract symptoms', 'male PMD patients', 'men with lower urinary tract symptoms (LUTSs', '102 male patients with PMD and other LUTSs']","['tadalafil', 'placebo', 'placebos', 'tadalafil 5mg and placebos']","['total HPMDQ scores and PMD volumes', 'PMD symptom severity and PMD volume', 'total HPMDQ score', 'Hallym PostMicturition Dribble Questionnaire (HPMDQ) and using PMD volume', 'quality of life', 'PMD', 'mean PMD volume', 'PMD frequency', 'moderate and significant PMD improvement']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1594297', 'cui_str': 'tadalafil 5 MG [Cialis]'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",102.0,0.441844,"Over 12 weeks, the total HPMDQ scores and PMD volumes improved significantly more in the tadalafil group than in the placebo group (reduction of total HPMDQ score by ≥ 2 points in the tadalafil and placebo group in 68.8% and 31.9% of patients, p < 0.001 and decreased mean PMD volume in the tadalafil and placebo group at 0.48 mL and 0.22 mL, p = 0.046, respectively).","[{'ForeName': 'Dae Yul', 'Initials': 'DY', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, College of Medicine, Kangdong Sacred Heart Hospital, Hallym Unversity, Seoul, Korea.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Jeong', 'Affiliation': 'Department of Urology, College of Medicine, Kangdong Sacred Heart Hospital, Hallym Unversity, Seoul, Korea.'}, {'ForeName': 'Kyungtae', 'Initials': 'K', 'LastName': 'Ko', 'Affiliation': 'Department of Urology, College of Medicine, Kangdong Sacred Heart Hospital, Hallym Unversity, Seoul, Korea.'}, {'ForeName': 'Seong Ho', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Dongtan Sacred Heart Hospital, Hallym Unversity, Hwaseong, Korea.'}, {'ForeName': 'Sang Kon', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Chuncheon Sacred Heart Hospital, Hallym Unversity, Chuncheon, Korea.'}, {'ForeName': 'Tae Young', 'Initials': 'TY', 'LastName': 'Shin', 'Affiliation': 'Department of Urology, College of Medicine, Chuncheon Sacred Heart Hospital, Hallym Unversity, Chuncheon, Korea.'}, {'ForeName': 'Jin Seon', 'Initials': 'JS', 'LastName': 'Cho', 'Affiliation': 'Department of Urology, College of Medicine, Hallym University Sacred Heart Hospital, Hallym Unversity, Anyang, Korea.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Chuncheon Sacred Heart Hospital, Hallym Unversity, Chuncheon, Korea.'}]",BJU international,['10.1111/bju.14849']
3688,31136070,Recommended antibiotic prophylaxis regimen in retrograde intrarenal surgery: evidence from a randomised controlled trial.,"OBJECTIVE


To study the incidence of postoperative systemic inflammatory response syndrome (SIRS) following different antibiotic prophylaxis (ABP) regimens in retrograde intrarenal surgery (RIRS).
PATIENTS AND METHODS


Single-centre, randomised, controlled trial (August 2014-September 2017) including 426 patients with renal stones with preoperative sterile urine managed by RIRS (ClinicalTrials.gov NCT02304822). Different ciprofloxacin-based ABP regimens were used and included a zero dose, single dose (30 min before surgery) or two doses (first dose at 30 min before RIRS and additional dose within 6 h after RIRS). The incidence of SIRS was compared using intention-to-treat (ITT) and per-protocol (PP) analyses.
RESULTS


Each group enrolled 142 patients. In the ITT analysis, a zero dose of ABP was statistically similar to the two ABP regimes for the incidence of SIRS (9.9% vs single dose 4.9%, P = 0.112; vs two doses 4.2%, P = 0.062). There were also no relevant differences across groups in the PP analysis; no urosepsis was recorded. In subgroup analysis with stratification by stone area, the three regimens all had a low and similar incidence of SIRS for stones of ≤200 mm 2  in the ITT analysis with a sufficient power value (5.4% vs 6.2% vs 3.6%, P = 0.945 vs single dose and P = 0.553 vs two doses). However, there was a greater chance of SIRS in patients who received no ABP with stones of >200 mm 2  (18% vs single dose 4.3%, P = 0.036; vs two doses 5.5%, P = 0.044). Similar trends were seen in the PP analysis.
CONCLUSIONS


For patients with preoperative sterile urine, ABP is not strongly recommended in patients with stones of ≤200 mm 2  , but for stones >200 mm 2  single-dose ABP is still required.",2019,"In subgroup analysis with stratification by stone area, the three regimens all had a low and similar incidence of SIRS for stones of ≤200 mm 2  in the ITT analysis with a sufficient power value (5.4% vs 6.2% vs 3.6%, P = 0.945 vs single dose and P = ","['Each group enrolled 142 patients', '426 patients with renal stones with preoperative sterile urine managed by RIRS (ClinicalTrials.gov NCT02304822']","['antibiotic prophylaxis regimen', 'antibiotic prophylaxis (ABP) regimens', 'ciprofloxacin-based ABP regimens']","['chance of SIRS', 'incidence of SIRS']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0042037'}]","[{'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0050372', 'cui_str': 'ABP regimen'}]","[{'cui': 'C0242966', 'cui_str': 'Sepsis Syndrome'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",142.0,0.468888,"In subgroup analysis with stratification by stone area, the three regimens all had a low and similar incidence of SIRS for stones of ≤200 mm 2  in the ITT analysis with a sufficient power value (5.4% vs 6.2% vs 3.6%, P = 0.945 vs single dose and P = ","[{'ForeName': 'Zhijian', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Hongling', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yongda', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Wenqi', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'de la Rosette', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Pilar Laguna Pes', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}]",BJU international,['10.1111/bju.14832']
3689,30476654,Colistin monotherapy versus colistin/rifampicin combination therapy in pneumonia caused by colistin-resistant Acinetobacter baumannii: A randomised controlled trial.,"OBJECTIVES


The aim of this study was to confirm the synergistic effect of colistin/rifampicin combination therapy compared with colistin monotherapy in pneumonia caused by colistin-resistant Acinetobacter baumannii (CoRAB). The utility of the Etest was also assessed.
METHODS


Nine subjects with pneumonia caused by CoRAB were enrolled from 20 July 2016 to 21 June 2018. Subjects were randomised to colistin/rifampicin combination therapy or colistin monotherapy. After exclusion of one patient who dropped out, the microbiological response (MR) and clinical response (CR) on Day 14 and mortality on Day 30 were assessed. Etest was conducted using CoRAB isolated at study enrolment.
RESULTS


The MR rate in the colistin/rifampicin combination group (100.0%) was better than that in the colistin group (40.0%), however the difference was not statistically significant (P=0.196). The CR rate was not significantly different between the two groups. The MR (100.0%) and CR (100.0%) rates in subjects with 'partial synergy' as shown by Etest were higher than those (25.0% and 50.0%, respectively) in subjects with 'indifferent' results (i.e. no synergistic effect), however the difference was not statistically significant (P=0.143 and 0.429, respectively). Mortality occurred in two subjects with 'indifferent' results by Etest.
CONCLUSIONS


Colistin/rifampicin combination therapy may have potential to achieve MR in pneumonia caused by CoRAB; however, achieving CR with this treatment is doubtful. 'Partial synergy' of colistin and rifampicin, as shown by Etest, may be a good prognostic factor [ClinicalTrial.gov ID: NCT03622918].",2019,The CR rate was not significantly different between the two groups.,"['Nine subjects with pneumonia caused by CoRAB were enrolled from 20 July 2016 to 21 June 2018', 'pneumonia caused by colistin-resistant Acinetobacter baumannii', 'pneumonia caused by colistin-resistant Acinetobacter baumannii (CoRAB']","['colistin/rifampicin combination therapy or colistin monotherapy', 'colistin monotherapy', 'Colistin monotherapy versus colistin/rifampicin combination therapy', 'rifampicin', 'colistin and rifampicin', 'colistin/rifampicin combination therapy', 'rifampicin combination therapy']","['MR rate', 'Mortality', 'CR rate', 'microbiological response (MR) and clinical response (CR) on Day 14 and mortality']","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0314787', 'cui_str': 'Acinetobacter baumannii'}]","[{'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",9.0,0.0247346,The CR rate was not significantly different between the two groups.,"[{'ForeName': 'Hye Jung', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro Gangnam-gu, Seoul 06273, South Korea.'}, {'ForeName': 'Jae Hwa', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Division of Pulmonology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro Gangnam-gu, Seoul 06273, South Korea.'}, {'ForeName': 'Hyung Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro Gangnam-gu, Seoul 06273, South Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seok Hoon', 'Initials': 'SH', 'LastName': 'Jeong', 'Affiliation': 'Department of Laboratory Medicine and Research Institute of Bacterial Resistance, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro Gangnam-gu, Seoul 06273, South Korea. Electronic address: kscpjsh@yuhs.ac.'}, {'ForeName': 'Min Kwang', 'Initials': 'MK', 'LastName': 'Byun', 'Affiliation': 'Division of Pulmonology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro Gangnam-gu, Seoul 06273, South Korea. Electronic address: littmann@yuhs.ac.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2018.11.016']
3690,30130691,Impact of early life adversity on the stress biobehavioral response during nicotine withdrawal.,"Exposure to early life adversity (ELA) is associated with increased subsequent risk for addiction and relapse. We examined changes in psychobiological responses to stress in dependent smokers and nonsmoking controls and evaluated how history of early adversity may exacerbate acute changes during nicotine withdrawal and acute stress. Smokers were randomly assigned to one of two conditions; 24 h withdrawal (66 smokers) from smoking and all nicotine-containing products or smoking ad libitum (46 smokers) prior to an acute laboratory stress induction session; and 44 nonsmokers provided normal referencing. The laboratory session included a baseline rest, stress and recovery periods. Plasma and saliva samples for the measurement stress hormones and cardiovascular and self-report mood measures were collected multiple times during the session. Multivariate analysis confirmed that all groups showed stress-related increases in negative mood, cardiovascular measures and stress hormones, particularly smokers in the withdrawal condition. Individuals with high ELA showed greater adrenocorticotropic hormone (ACTH), but lower plasma and salivary cortisol levels, than those with low ELA. Cortisol differences were abolished during tobacco withdrawal. These findings demonstrate that ELA moderates the effects of withdrawal on stress-related biobehavioral changes.",2018,"Individuals with high ELA showed greater adrenocorticotropic hormone (ACTH), but lower plasma and salivary cortisol levels, than those with low ELA.",[],"['nicotine withdrawal', '24\u2009h withdrawal (66 smokers) from smoking and all nicotine-containing products or smoking ad libitum (46 smokers) prior to an acute laboratory stress induction session; and 44 nonsmokers provided normal referencing', 'ELA']","['negative mood, cardiovascular measures and stress hormones', 'plasma and salivary cortisol levels', 'Cortisol differences', 'stress biobehavioral response', 'adrenocorticotropic hormone (ACTH']",[],"[{'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal (disorder)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}]",,0.0184606,"Individuals with high ELA showed greater adrenocorticotropic hormone (ACTH), but lower plasma and salivary cortisol levels, than those with low ELA.","[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': ""al'Absi"", 'Affiliation': 'Department of Family Medicine and Biobehavioral Health University of Minnesota Medical School, Duluth, MN, USA. Electronic address: malabsi@umn.edu.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Nakajima', 'Affiliation': 'Department of Family Medicine and Biobehavioral Health University of Minnesota Medical School, Duluth, MN, USA.'}, {'ForeName': 'Andrine', 'Initials': 'A', 'LastName': 'Lemieux', 'Affiliation': 'Department of Family Medicine and Biobehavioral Health University of Minnesota Medical School, Duluth, MN, USA.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2018.08.022']
3691,31235374,"Safety, immunogenicity and lot-to-lot consistency of a new Bivalent Oral Polio Vaccine (bOPV) in healthy Infants: Results of a Phase III, observer blind, randomized, controlled clinical study.","BACKGROUND


Poliomyelitis infection continues to be endemic in few countries despite rigorous efforts for eradication. A new Bivalent Oral Polio Vaccine (BBio bOPV) was tested in a Phase III Clinical study.
METHODS


An observer blind, randomized, controlled clinical study was conducted comparing BBio bOPV with a licensed bOPV (SII bOPV). Initially in Part 1, 40 children 5-6 years of age were given a single dose of either vaccine in 1:1 ratio. In Part 2, 1080 infants of 6-8 weeks of age were received in 1:1:1:1 ratio one of the 3 lots of BBio bOPV or SII bOPV at 6, 10 and 14 weeks of age. Blood samples were collected to assess neutralizing antibody responses against Polio Type 1 and 3 viruses. Safety of the vaccines were recorded.
RESULTS


All children were seroprotected against both Type 1 and Type 3 polioviruses post-vaccination. More than 96% of the infants demonstrated seroconversion as well as seroprotection against both types of polioviruses. The geometric mean titres (GMT) for Type 1 and Type 3 antibodies were comparable between the groups. The 3 lots of BBio bOPV generated similar GMTs of Type 1 and Type 3 antibodies. In total 387 participants reported at least one adverse event and 18 serious adverse events. None of these events were vaccine related.
CONCLUSIONS


The new bOPV vaccine demonstrated immunogenicity that was non-inferior to a licensed bOPV vaccine. Consistency in immune response by 3 consecutively manufactured lots was also demonstrated. The vaccine did not cause any adverse event. Clinicaltrials.gov.identifier: NCT02766816.",2019,More than 96% of the infants demonstrated seroconversion as well as seroprotection against both types of polioviruses.,"['40 children 5-6\u202fyears of age', 'healthy Infants', '1080 infants of 6-8\u202fweeks of age']","['new Bivalent Oral Polio Vaccine (bOPV', 'Oral Polio Vaccine (BBio bOPV', 'BBio bOPV or SII bOPV', 'vaccine', 'BBio bOPV with a licensed bOPV (SII bOPV']","['adverse event and 18 serious adverse events', 'geometric mean titres (GMT']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0023636', 'cui_str': 'Permits'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.115087,More than 96% of the infants demonstrated seroconversion as well as seroprotection against both types of polioviruses.,"[{'ForeName': 'Khalequ', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh. Electronic address: kzaman@icddrb.org.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kingma', 'Affiliation': 'Bilthoven Biologicals, Bilthoven, Netherlands.'}, {'ForeName': 'Md', 'Initials': 'M', 'LastName': 'Yunus', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Ineke', 'Initials': 'I', 'LastName': 'van Straaten', 'Affiliation': 'Bilthoven Biologicals, Bilthoven, Netherlands.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Mekkes', 'Affiliation': 'Bilthoven Biologicals, Bilthoven, Netherlands.'}, {'ForeName': 'Xandra', 'Initials': 'X', 'LastName': 'Bouwstra', 'Affiliation': 'Bilthoven Biologicals, Bilthoven, Netherlands.'}, {'ForeName': 'Bhagwat', 'Initials': 'B', 'LastName': 'Gunale', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Prasad S', 'Initials': 'PS', 'LastName': 'Kulkarni', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}]",Vaccine,['10.1016/j.vaccine.2019.06.048']
3692,31895867,Three-month Storage of Human Corneas in an Active Storage Machine.,"BACKGROUND


Corneal storage for the very long term, without degradation, would make it possible to optimize a very limited resource worldwide. We previously demonstrated the superiority, compared to conventional 4-week passive organ culture (OC), of an active storage machine (ASM) that restores intraocular pressure and medium renewal. Here, we investigate eye banking for up to 3 months.
METHODS


In a randomized preclinical trial with 24 paired corneas, 1 was stored in OC and the other in ASM, using the same medium. Assessments were done on the second day and at 3 months: endothelial cell density (ECD in cells/mm), corneal transparency and thickness. At day 86, OC corneas were deswelled in a common hyperosmotic medium, but not the ASM corneas, which had remained thin. In addition, at day 88, viable ECD was measured using a live/dead assay, and endothelial expression of Na/K ATPase, Cox IV, ZO-1, N-CAM, and CD166 was observed.
RESULTS


The ASM extended storage to 3 months with unprecedented endothelial cell quality: no OC corneas remained suitable for transplantation, but one-third of ASM corneas were compliant (ECD > 2000/mm). Given that corneas with ECD > 1600/mm were also usable for emergency, 58% of ASM corneas were usable versus 33% in OC. EC survival was 53% higher in ASM (P < 0.001), structural and functional proteins of ECs were much better preserved in ASM, and it prevented the constant major edema of OC.
CONCLUSIONS


By extending graft survival to 3 months, the ASM will optimize eye banking and open up new perspectives in experimental research.",2020,"EC survival was 53% higher in ASM (p<0.001), structural and functional proteins of ECs were much better preserved in ASM, and it prevented the constant major edema of OC.
",[],"['conventional 4-week passive organ culture (OC), of an active storage machine (ASM']","['live/dead assay, and endothelial expression of Na/KATPase, Cox-IV, ZO-1, N-CAM and CD166', 'endothelial cell density (ECD in cells/mm), corneal transparency and thickness', 'EC survival']",[],"[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0029205', 'cui_str': 'Organ Culture Techniques'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}]","[{'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0431232,"EC survival was 53% higher in ASM (p<0.001), structural and functional proteins of ECs were much better preserved in ASM, and it prevented the constant major edema of OC.
","[{'ForeName': 'Thibaud', 'Initials': 'T', 'LastName': 'Garcin', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Gauthier', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Crouzet', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Herbepin', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Perrache', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Acquart', 'Affiliation': 'Eye Bank, French Blood Center, Saint-Etienne, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Cognasse', 'Affiliation': 'Eye Bank, French Blood Center, Saint-Etienne, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Forest', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gain', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Thuret', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}]",Transplantation,['10.1097/TP.0000000000003109']
3693,31429960,Of Drowning Children and Doubtful Analogies.,"In this issue of the Hastings Center Report, James Sabin and his colleagues ask what responsibility investigators in a learning health organization have to patients when research-particularly research of which patients might be unaware-illuminates problematic aspects of the patients' care. Sabin and his colleagues were confronted by this question in the midst of designing a randomized controlled trial that sought to determine if an educational intervention targeted at patients with atrial fibrillation and their clinicians reduces underuse of oral anticoagulants. Worried about harm that might befall patients in the control group and fearing that they would be negligent bystanders if they knew these patients were at risk and did nothing, the investigators adopted a ""workaround."" But the ""workaround,"" I suggest, was not a solution to the negligent bystander problem. Nor was it a solution to the problem as I would alternatively frame it-how to address instances of suboptimal patient care identified through research within learning health organizations.",2019,"Worried about harm that might befall patients in the control group and fearing that they would be negligent bystanders if they knew these patients were at risk and did nothing, the investigators adopted a ""workaround.""",['patients with atrial fibrillation and their clinicians reduces underuse of oral anticoagulants'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}]",[],[],,0.0344128,"Worried about harm that might befall patients in the control group and fearing that they would be negligent bystanders if they knew these patients were at risk and did nothing, the investigators adopted a ""workaround.""","[{'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Largent', 'Affiliation': ''}]",The Hastings Center report,['10.1002/hast.1032']
3694,31863046,10 year comparison of glass ionomer and composite resin restoration materials in class 1 and 2 cavities.,"Data sources A prospective randomised, double-blinded controlled trial Study selection Those requiring routine dental care in Sihhiye, Turkey were eligible to participate. Eighty-seven participants were identified and assessed for eligibility by calibrated researchers who ensured that the inclusion and exclusion criteria were met. Fifty-nine participants were successfully recruited with an average age of 24 years (range 15-37).Restoration type were randomly allocated [glass ionomer (GI) or composite resin (CR)] using a table of random numbers with software 'Research Randomised Program' and four experimental groups were created.Two dentists with 5 years experience were calibrated by them placing ten trial restorations , which were not included in the study. One hundred and forty restorations were then placed adhering to a strict treatment protocol. Cavities which did not meet the specifications of the criteria were excluded. The study received ethical approval by the Human Ethics in Clinical Research Committee of the University.Data extraction and synthesis Restorations were assessed at baseline (1 week), 1, 2, 3, 4, 5, 6, 8 and 10 years by blinded calibrated examiners with the aid of colour photographs using an objective criteria. Scanning electron microscopy (SEM) analysis was performed for one randomly selected restoration per group at each assessment. Data analysis adhered to the intention-to-treat CONSORT protocol. The restoration retention rates were calculated, and statistical analysis preformed using IBM SPSS version 22.0. The performance of the restorative materials over the study period were analysed with Cochran's Q test, according to USPHS criteria. Whilst the McNemar test was used to assess aspects of each material with baseline for each cavity type in addition to difference between cavity types. Marginal adaption, marginal discolouration and colour scores in each study group were compared with the p value set at 0.05.Results Eighty-seven patients with 203 lesions were included in the study, with 59 (140 lesions) eligible. Eleven patients were excluded for not meeting the inclusion/ exclusion criteria with 17 refusing to participate. Four randomly allocated groups were created at baseline, as combinations of cavity type and restorative material. 86.4% (n=51) of participants were evaluated after 10 years. The cumulative failure rate (CRF) was 3.17%.Marginal discolouration was observed in all groups at 10 years. With a significant difference observed between Class I and Class II cavities with GI restorations (p = 0.022). In addition, a significant change in colour match in GI restorations after 10 years(<0.005) was found.Over the ten-year period, no significant change was observed in terms of marginal adaption, anatomical form, secondary caries, postoperative sensitivity, surface texture, and retention for either restorative material (p >0.05) or with SEM inspections.Conclusions Both GI and CR are suitable and similar restorative materials for class 1 and class 2 cavities. However, differences can occur in colour change within the materials with glass ionomer restorations showing greater colour change from baseline over this period.",2019,With a significant difference observed between Class I and Class II cavities with GI restorations (p = 0.022).,"['Fifty-nine participants were successfully recruited with an average age of 24 years (range 15-37).Restoration type', 'Eleven patients were excluded for not meeting the inclusion/ exclusion criteria with 17 refusing to participate', '10 year comparison of glass ionomer and composite resin restoration materials in class 1 and 2 cavities', 'One hundred and forty restorations', 'Eighty-seven participants were identified and assessed for eligibility by calibrated researchers who ensured that the inclusion and exclusion criteria were met', '0.05.Results Eighty-seven patients with 203 lesions were included in the study, with 59 (140 lesions) eligible', 'Two dentists with 5 years experience were calibrated by them placing ten trial restorations , which were not included in the study']",['glass ionomer (GI) or composite resin (CR'],"['colour match in GI restorations', 'cumulative failure rate (CRF', 'Marginal adaption, marginal discolouration and colour scores', 'Class I and Class II cavities with GI restorations', 'Data extraction and synthesis Restorations', 'marginal adaption, anatomical form, secondary caries, postoperative sensitivity, surface texture, and retention for either restorative material', 'restoration retention rates']","[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}]","[{'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1882989', 'cui_str': 'Secondary caries'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]",87.0,0.0562563,With a significant difference observed between Class I and Class II cavities with GI restorations (p = 0.022).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hutchison', 'Affiliation': 'Glasgow Dental Hospital and School, Glasgow, Scotland, UK. clare.hutchison1@nhs.ne.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cave', 'Affiliation': 'Glasgow Dental Hospital and School, Glasgow, Scotland, UK.'}]",Evidence-based dentistry,['10.1038/s41432-019-0059-9']
3695,31923472,Study protocol: CareAvenue program to improve unmet social risk factors and diabetes outcomes- A randomized controlled trial.,"Despite the burdens costs can place on adults with diabetes, few evidence-based, scalable interventions have been identified that address prevalent health-related financial burdens and unmet social risk factors that serve as major obstacles to effective diabetes management. In this study, we will test the effectiveness of CareAvenue - an automated e-health tool that screens for unmet social risk factors and informs and activates individuals to take steps to connect to resources and engage in self-care. We will determine the effectiveness of CareAvenue relative to standard care with respect to improving glycemic control and patient-centered outcomes such as cost-related non-adherence (CRN) behaviors and perceived financial burden. We will also examine the role of patient risk factors (moderators) and behavioral factors (mediators) on the effectiveness of CareAvenue in improving outcomes. We will recruit 720 patients in a large health system with uncontrolled Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) who engage in CRN or perceive financial burden. Participants will be randomized to one of two arms: 1) receipt of a 15-20 min web-based program with routine follow-up (CareAvenue); or 2) receipt of contact information for existing health system assistance services. Outcomes will be assessed at baseline and 6- and 12-month follow-up. Clinical Trial Registration: ClinicalTrials.gov ID NCT03950973, May 2019.",2020,"In this study, we will test the effectiveness of CareAvenue - an automated e-health tool that screens for unmet social risk factors and informs and activates individuals to take steps to connect to resources and engage in self-care.","['720 patients in a large health system with uncontrolled Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) who engage in CRN or perceive financial burden', 'adults with diabetes']",['receipt of a 15-20\u202fmin web-based program with routine follow-up (CareAvenue); or 2) receipt of contact information for existing health system assistance services'],['unmet social risk factors and diabetes outcomes'],"[{'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",720.0,0.0729143,"In this study, we will test the effectiveness of CareAvenue - an automated e-health tool that screens for unmet social risk factors and informs and activates individuals to take steps to connect to resources and engage in self-care.","[{'ForeName': 'Minal R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America. Electronic address: minalrp@umich.edu.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America; Department of Internal Medicine, Michigan Medicine, United States of America; U.S. Department of Veterans Affairs VA, Ann Arbor Healthcare System, United States of America.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Piette', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America; U.S. Department of Veterans Affairs VA, Ann Arbor Healthcare System, United States of America.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Peter X K', 'Initials': 'PXK', 'LastName': 'Song', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Hae Mi', 'Initials': 'HM', 'LastName': 'Choe', 'Affiliation': 'College of Pharmacy, University of Michigan, United States of America; University of Michigan Medical Group, United States of America.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Tobi', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105933']